• Approval granted for all indications and all age groups including children and newborns
• First high relaxivity low-dose MRI contrast agent in Japan – 60 percent less gadolinium compared to products on the Japanese market
• Further submissions to health authorities worldwide ongoing to secure marketing authorization in additional markets
   

Berlin, March 23, 2026 – Bayer today announced the world’s first approval of the MRI contrast agent gadoquatrane by the Ministry of Health, Labour, and Welfare in Japan. The next-generation high relaxivity low-dose macrocyclic gadolinium-based contrast agent (GBCA) is approved under the brand name Ambelvist™ for detecting and visualizing known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including newborns. The product delivers the lowest gadolinium (Gd) dose of all macrocyclic MRI contrast agents, with a 60% reduction per procedure compared to current options on the Japanese market, while maintaining image quality.

In light of health authority guidance and medical societies consistently recommending the lowest dose to achieve diagnostic goals, there is a clear demand for low-dose MRI contrast agents worldwide, including Japan. “All medicines should be administered at the lowest effective dose, and MRI contrast agents are no exception,” said Prof. Kohsuke Kudo, Department of Diagnostic Imaging, Hokkaido University, Japan. “Reducing patients’ lifetime exposure to gadolinium is therefore an important consideration. This is particularly relevant for patients with chronic conditions such as cancer and cardiovascular disease who require repeated MRI examinations, as well as for those with renal impairment and for pediatric patients. By substantially reducing the gadolinium dose while maintaining diagnostic image quality, gadoquatrane may represent a highly valuable option in advancing patient-centered care.”

With an aging population and an increase in chronic diseases such as cancer and heart disease, Japan has the highest number of MRI scanners per capita worldwide. Gadoquatrane is the first low-dose MRI contrast agent available on the Japanese market.

The approval is based on the clinical development program for gadoquatrane including the pivotal Phase III QUANTI studies and a Phase I/III pediatric study.

“This first approval for Ambelvist™ is supported by compelling clinical data, underlining its diagnostic value for broad clinical use. The approved comprehensive label in Japan comprises all patient populations and age groups, reducing the need for alternative agents for different patient populations,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “With this next generation high-relaxivity, low-dose MRI contrast agent demonstrating high stability, Bayer responds to the evolving demand for low-dose options to achieve diagnostic goals. This also showcases our commitment to advancing radiology with innovations that support patients and their treating physicians in getting clear answers about their health.”

Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world, including the U.S., the EU, and China, with more to follow. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available on the respective markets.

About QUANTI
The pivotal QUANTI clinical development program for gadoquatrane consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study in children. All studies evaluated gadoquatrane with a dose of 0.04 mmol gadolinium (Gd) per kilogram body weight. Images were assessed in a blinded, independent central read, with similar visualization scores for gadoquatrane compared to the macrocyclic trial comparators dosed at 0.1 mmol Gd/kg body weight while reducing the gadolinium dose by 60 percent. Several sub-analyses – including cardiac, abdominal and CNS imaging as well as magnetic resonance angiography (MRA) – confirmed the non-inferior performance of gadoquatrane in several clinical settings compared to the trial comparators. The pediatric study demonstrated similar pharmacokinetic and safety profiles for gadoquatrane in the pediatric population and adults, indicating that its diagnostic performance in adults can also be applied to children.

Across all studies, the observed safety profile was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.

About gadoquatrane
Gadoquatrane is Bayer’s extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.

The compound has been approved in Japan under the brand name Ambelvist™ in March 2026. It has not been approved in any other jurisdiction. Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world.

About MRI
MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. MRI contrast agents commonly contain gadolinium. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide. Cumulatively, since 1988, more than 900 million GBCA doses have been delivered globally.

About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

“We are pleased the Court granted preliminary approval of the class settlement, which is designed to resolve current and potential future Roundup claims relating to NHL,” said Bill Dodero, Senior Vice President & General Counsel of Bayer. “This is the first major step in putting this settlement into effect, and we remain confident that the long-term and well-financed class settlement plan, which is supported by leading plaintiffs’ law firms, warrants final approval by the court.”

Following preliminary approval, the next step in the legal process involves notice to potential class members and a 90-day period, ending on June 4, during which members of the class can opt out or file objections. Once this next phase is complete, the court will hold a fairness hearing on July 9 and decide whether to grant final approval of the settlement, which will be subject to potential appeals. All lawsuits in Missouri brought by class settlement members are stayed, except for opt outs, until the Court reaches a final judgement on the class settlement.

The class settlement follows a decision by the U.S. Supreme Court to grant review of the Durnell case. The expectation of Supreme Court review of the cross-cutting question in this litigation – whether state claims based on failure-to-warn theories are preempted by federal law – helped make this settlement possible. The Supreme Court case is unaffected by the settlement and is critical to resolving substantial outstanding damage awards subject to pending appeals, which are not covered by the settlement. The Supreme Court case is also critical to resolving the regulatory uncertainty which jeopardizes the availability of current and future agricultural innovations, with potentially severe consequences for farmers and the American food system.

“The proposed class, combined with Supreme Court review in Durnell, are independently necessary and mutually reinforcing steps in the Company’s multipronged strategy to significantly contain the Roundup™ litigation,” Dodero continued.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Looking ahead, Bayer expects 2026 to be a year of solid sales and stable earnings on a currency-adjusted basis. “That outlook is emblematic of the company’s current strategic position: strong signs of progress, but still working on a comprehensive turnaround. We’ve made major gains across the company, but that work is not yet complete,” Anderson explained, adding: “We have a clear picture of what needs to be done in every area.” Moreover, Bayer’s multi-pronged strategy to contain the U.S. litigations proceeds apace, he noted, with the company having last month announced a class settlement agreement to resolve current and future claims relating to Roundup™ (glyphosate). In addition, Bayer continues to implement Dynamic Shared Ownership and expects to realize the targeted two billion euros in savings through the new operating model.

Group sales edge higher (Fx & portfolio adj.), net financial debt reduced

Group sales rose by 1.1 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 45.575 billion euros in 2025. There was a negative currency effect of 1.742 billion euros. EBITDA before special items decreased by 4.5 percent to 9.669 billion euros, and included a negative currency effect of 491 million euros that impacted all divisions. EBIT amounted to minus 1.077 billion euros (2024: minus 71 million euros) after net special charges of 6.185 billion euros (2024: 5.507 billion euros) that mainly resulted from litigation-related expenses. Net income came in at minus 3.620 billion euros (2024: minus 2.552 billion euros). Core earnings per share decreased by 2.8 percent to 4.91 euros, mainly due to the decline in earnings in the Pharmaceuticals and Crop Science divisions. However, the improved financial result had a positive impact.

Free cash flow declined by 32.9 percent to 2.084 billion euros. Net financial debt as of December 31, 2025, came in at 29.843 billion euros, representing a reduction of 8.5 percent against year-end 2024 that was mainly driven by cash inflows from operating activities as well as positive currency effects of 1.370 billion euros. At the upcoming Annual Stockholders’ Meeting on April 24, 2026, the company will be proposing a dividend of 0.11 euros per share for 2025, in line with the dividend paid for 2024.

Gains in corn seed business drive topline growth (Fx & portfolio adj.) at Crop Science

In the agricultural business (Crop Science), sales advanced by 1.1 percent (Fx & portfolio adj.) to 21.622 billion euros, with growth mainly driven by Corn Seed & Traits. Buoyed by gains across all regions, the Corn business registered a 13.2 percent (Fx & portfolio adj.) rise in global sales thanks to strong product performance, an increase in planted area and the resolution of a licensing agreement with Corteva in North America. Factoring out the resolution of the licensing agreement, sales at Corn Seed & Traits would have still grown just under 10 percent (Fx & portfolio adj.). Business was also up at Vegetable Seeds, with sales advancing 7.5 percent (Fx & portfolio adj.) due to higher prices and volumes in nearly all regions. Sales at Herbicides were at the prior-year level (Fx & portfolio adj. plus 0.5 percent), with sales of glyphosate-based products also remaining stable year on year (Fx & portfolio adj. plus 0.1 percent). Business at Fungicides was down 4.8 percent (Fx & portfolio adj.) against the prior year, largely due to declines in North America and Asia/Pacific from market- and weather-related factors. Sales at Insecticides declined 12.2 percent (Fx & portfolio adj.), with business impacted by the expiration of the Movento™ registration in Europe. As anticipated, sales at Soybean Seed & Traits and Cotton Seed decreased – by 7.7 percent (Fx & portfolio adj.) and 22.9 percent (Fx & portfolio adj.), respectively – due to the vacatur of the label for dicamba-based crop protection products in the United States.

EBITDA before special items at Crop Science decreased by 3.2 percent to 4.188 billion euros, and included a negative currency effect of 208 million euros (2024: positive currency effect of 37 million euros). Earnings benefited from strong growth at Corn Seed & Traits and cost savings from efficiency programs. By contrast, earnings were impacted by regulatory headwinds, higher expenses for the Group-wide short-term incentive (STI) program and strategic actions, including costs associated with portfolio streamlining and the absence of prior-year income from the divestment of noncore businesses. The EBITDA margin before special items came in at 19.4 percent, and was therefore unchanged from the prior-year figure.

Pharmaceuticals posts higher sales (Fx & portfolio adj.) thanks mainly to gains for Nubeqa™ and Kerendia™

Sales of prescription medicines (Pharmaceuticals) increased by 1.7 percent (Fx & portfolio adj.) to 17.829 billion euros. Bayer again registered significant gains for Nubeqa™, for the treatment of cancer, and Kerendia™, for the treatment of chronic kidney disease associated with type 2 diabetes, as well as heart failure. Sales of these two products rose by 62.4 percent and 88.0 percent (Fx & portfolio adj.), respectively. In addition, sales of the long-term contraceptives in the Mirena™ product family continued to advance substantially, with business up 12.5 percent (Fx & portfolio adj.) thanks to higher volumes in the United States. The Radiology business also continued to post strong gains that were fueled by volume growth for Ultravist™ und CT Fluid Delivery. By contrast, business headwinds mainly related to declines for Xarelto™ and Eylea™. Sales of the oral anticoagulant fell by 31.6 percent (Fx & portfolio adj.) due to patent expirations, while the ophthalmology drug saw a decline of 3.7 percent (Fx & portfolio adj.) that was primarily attributable to lower prices, especially in Canada, the United Kingdom and Japan, as well as competitive pressure from generics. However, the launch of  Eylea™ 8 mg offering extended treatment intervals provided a significant boost and accounted for a growing share of overall Eylea™ sales (around 38 percent in the fourth quarter).

EBITDA before special items at Pharmaceuticals decreased by 4.2 percent to 4.525 billion euros. The decline in earnings was mainly attributable to an increase in selling expenses that primarily related to the launch of Nubeqa™ and Kerendia™ in new indications, as well as the market launch of Lynkuet™ (active ingredient: elinzanetant), a hormone-free treatment for symptoms associated with the menopause, the cardiology drug Beyonttra™ (active ingredient: acoramidis) and Hyrnuo™ (active ingredient: sevabertinib), for the treatment of patients with previously treated advanced HER2-mutant non-small cell lung cancer. There was also a negative currency effect of 213 million euros (2024: 491 million euros). Earnings were additionally diminished by higher investments in early-stage research and in cell and gene therapy and chemoproteomics technologies. By contrast, an inventory write-down reversal and lower expenses for late-stage clinical development projects had a positive impact. In addition, negative pricing developments in connection with patent expirations and the Inflation Reduction Act in the United States were fully offset by a strong increase in volumes. The EBITDA margin before special items declined by 0.6 percentage points to 25.4 percent.

Consumer Health: Stable sales (Fx & portfolio adj.) amid challenging market environment

Sales of self-care products (Consumer Health) came in at 5.802 billion euros, in line with the prior year (Fx & portfolio adj. minus 0.1 percent), as the division navigated a challenging environment in key markets, notably in the United States and China. Business was up in the Digestive Health, Dermatology and Pain & Cardio categories, with gains of 3.7 percent, 2.4 percent and 2.1 percent (Fx & portfolio adj.), respectively. By contrast, sales declined by 3.9 percent (Fx & portfolio adj.) at Nutritionals and by 3.0 percent (Fx & portfolio adj.) at Allergy & Cold, with business in the latter category primarily impacted by a soft allergy season in North America and lower sales of cough and cold products in Latin America.

EBITDA before special items at Consumer Health decreased by 1.8 percent to 1.341 billion euros. Earnings were impacted by a negative currency effect of 73 million euros (2024: 46 million euros) that the division was able to partially offset thanks to its continuous cost and price management efforts. Investments in product marketing were at the prior-year level, while overall selling expenses were down. The EBITDA margin before special items came in at 23.1 percent, 0.2 percentage points below the prior-year level.

Group outlook for 2026: Stable sales and earnings (Fx adj.)

On a currency-adjusted basis (i.e. based on the average monthly exchange rates in 2025), Bayer expects to generate sales of 45 billion to 47 billion euros in 2026. This corresponds to a year-on-year change of 0 to plus 3 percent on a currency- and portfolio-adjusted basis. As part of its currency-adjusted forecast, the company also expects to post EBITDA before special items of 9.6 billion to 10.1 billion euros. With respect to core earnings per share, the company is updating the way it calculates this metric in order to provide enhanced transparency around its current operational performance. In addition to the depreciation of property, plant and equipment that is already accounted for as part of the existing approach, the updated methodology also factors in the amortization of certain intangible assets, in particular software. Had the new methodology been applied for 2025, core earnings per share would have amounted to 4.57 euros (compared with 4.91 euros based on the existing approach). Applying the updated methodology, currency-adjusted core earnings per share are expected to come in at 4.30 to 4.80 euros in 2026. Free cash flow is projected to amount to between minus 2.5 billion and minus 1.5 billion euros, reflecting approximately 5 billion euros in payouts in connection with litigations, as previously communicated. In addition, net financial debt as of year-end is expected to amount to 32.0 billion to 33.0 billion euros.

Bayer has also prepared its guidance based on the closing exchange rates as of December 31, 2025. With the company anticipating significant currency fluctuations in 2026, this guidance deviates from the currency-adjusted forecast above as follows: At Group level, Bayer expects to post sales of 44 billion to 46 billion euros, EBITDA before special items of 9.1 billion to 9.6 billion, and core earnings per share of 4.00 to 4.50 euros (based on the updated methodology outlined above).

Sustainability: Bayer makes further progress towards achieving its targets

Bayer remains well on track to hit its sustainability targets. Regarding its social sustainability targets, the company last year expanded access to self-care to 82 million people in economically or medically underserved communities, provided 68 million women in low- and middle-income countries with access to modern contraception, and supported 53 million smallholder farmers with products and services. Bayer is aiming to hit the 100-million mark in each of these areas by 2030.

Bayer is also making good progress on the climate action front. In 2025, for example, over half of the electricity purchased by the company came from renewable sources, marking the first time it has crossed this threshold. Bayer sites in Brazil, France and Spain are already utilizing renewables to satisfy 100 percent of their energy needs.

The company’s continued strides in the field of sustainability are also gaining recognition from rating agencies, with Bayer securing an AA rating from MSCI solutions for the first time. In addition, Sustainalytics lifted its “red flag” for Bayer at the end of 2025, pointing to the headway made in containing the litigation risk relating to glyphosate. This means that, overall, Bayer now has the best sustainability rating profile in its history across the various rating agencies.

Two new candidates for the Supervisory Board

At the upcoming Annual Stockholders’ Meeting on April 24, 2026, two stockholder representatives will be put forward for election to the Supervisory Board. The candidates being proposed by the Supervisory Board are Marcel Smits (64) and Alfred Stern (61). Marcel Smits was formerly Chairman and CEO of Asia Pacific and Global Head of Strategy at Cargill from 2018 to 2022. Prior to this role, he spent over five years as Cargill’s CFO. He currently operates as a seed and early-stage investor of several start-ups. His experience managing global agricultural and food businesses with complex supply chains will be highly valuable to the Supervisory Board. Alfred Stern is currently the CEO and Chairman of the Executive Board at OMV, where he has led the transition of the business to focus on integrated sustainable energy, fuels and chemicals. He has held this role since 2021 and will be stepping down after his term ends this coming August. Alfred Stern brings executive leadership experience, deep knowledge of the DACH region, and governance, environment and sustainability expertise to the Supervisory Board. Long-serving Supervisory Board members Paul Achleitner (69) and Colleen Goggins (71) will not be standing for reelection once their terms of office come to an end at the 2026 Annual Stockholders’ Meeting.

Notes:

The following tables contain the key data for the Bayer Group and its divisions for the full year and the fourth quarter of 2025.

The complete Annual Report 2025 is published online at:
www.bayer.com/annualreport. There is also a digital version available featuring selected sections of the report.

The speech given by the Bayer Board of Management to the media will be available online from around 10 a.m. CET at: www.bayer.com/speeches

Live broadcast of the Financial News Conference from around 10 a.m. CET and recording available from around 1 p.m. CET at: www.bayer.com/live-mc

Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CET) and recording (from around 6 p.m. CET) available at: www.bayer.com/live-ic

Print-quality photos will be available here shortly after the news conference.

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

“A stroke is a life-changing event for patients and a major public health burden. The findings from OCEANIC-STROKE are a notable research achievement, demonstrating a substantial reduction in the risk of stroke with asundexian compared to placebo, alongside a sustained treatment effect and a safety profile with no observed increase in ISTH major bleeding,” said Mike Sharma, Principal Investigator of the OCEANIC-STROKE study, Michael G. DeGroote Chair in Stroke Prevention, McMaster University and Senior Scientist at Population Health Research Institute, a joint institute of McMaster University and Hamilton Health Sciences. “For clinicians and researchers who have spent decades working to reduce the global burden of secondary stroke, the OCEANIC-STROKE results represent the kind of scientific progress the field has long been striving to achieve.”

Alongside the primary findings, secondary endpoints showed asundexian reduced the risk of a stroke of any kind (ischemic and hemorrhagic) by 26 percent (6.6% vs. 8.8%; csHR 0.74; 95% CI, 0.65–0.84; p<.0001) compared to placebo. In addition, the following secondary efficacy endpoints were met for asundexian compared to placebo, when both were given in combination with antiplatelet therapy: the composite endpoint of cardiovascular death, myocardial infarction (MI) or stroke, and the composite of death from any cause, MI or stroke.

The analysis of the primary safety endpoint showed that there was no increase in the rate of ISTH major bleeding with asundexian compared to placebo (1.9% vs. 1.7%; HR 1.10; 95% CI, 0.85–1.44). For the pre-specified secondary safety endpoints, the risk of bleeding was similar compared to the rates seen in the placebo-arm.

OCEANIC-STROKE enrolled all common stroke subtypes in its design, classified by the TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. Among patients with an index ischemic stroke, the study enrolled patients with large-artery atherosclerosis (43 percent), small-vessel occlusion (lacune) (23 percent), stroke of undetermined etiology (30 percent), other determined etiology (3 percent), and cardioembolic stroke (2 percent). Across all TOAST subtypes evaluated, rates of recurrent ischemic stroke were lower with asundexian compared with placebo.

“The consistent reduction in secondary events with asundexian across all types of strokes included in the trial, is particularly striking” said Ashkan Shoamanesh, Co-Principal Investigator of OCEANIC-STROKE study and PHRI senior scientist. “OCEANIC-STROKE was deliberately designed with the goal of making the findings generalizable to the many ways stroke presents in clinical practice. These results provide confidence that, if approved, asundexian could become an important option for secondary stroke prevention across a broad range of stroke patients.”

Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30 percent will be a recurrent stroke.^1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high. One in five stroke survivors will have another stroke within five years.³ Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.^2,4,5

“Stroke is a public health crisis and with the groundbreaking results of OCEANIC-STROKE, I believe Asundexian can contribute meaningfully to improve life for patients and care partners, delivering positive impact to health systems worldwide,” said Christian Rommel, Ph.D., Global Head of Research and Development, Bayer Pharmaceuticals. “We would like to offer our sincere appreciation to investigators and patients who participated in this study and look forward to discuss the results with regulatory authorities as a next step.”

Bayer will submit the data from OCEANIC-STROKE to health authorities forapproval of marketing authorizations of asundexian. The compound has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.

About OCEANIC-STROKE 
The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary endpoint was time to ischemic stroke; the primary safety endpoint was major bleeding.

About FXIa inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.

Asundexian is a once daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. 

About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. The company has set a clear focus on developing innovative therapies to treat such diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

^1.         Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29.

^2.         Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206.

^3.         Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935.

^4.         Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552.

^5.         Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42.

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.¹ In China, the burden of prostate cancer has increased significantly in recent years; it’s expected incidence and mortality rates will continue to rise in the next decade, with an estimated 315,310 new cases and 81,540 deaths by 2030.²

“mHSPC is a crucial treatment window to delay progression to poor prognosis mCRPC.” said Professor Xing Nianzeng, Cancer Hospital Chinese Academy of Medical Sciences, China. “Over the past decade, the treatment for mHSPC has evolved from ADT alone to combination regimens. Darolutamide, new-generation androgenreceptor inhibitor, is increasingly becoming standard therapy for mHSPC. Darolutamide plus ADT (with docetaxel in ARASENS) improves overall survival, and ARANOTE shows an effective darolutamide-based option without docetaxel for patients who cannot or will not receive chemotherapy.”

“The rising incidence of prostate cancer in China poses a serious threat to men’s health, and highlights that patients need personalized support,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This third approval for darolutamide is supported by compelling clinical data from the ARANOTE trial which reaffirms its efficacy, safety and tolerability. Darolutamide can now be used with or without chemotherapy in China, offering physicians greater flexibility to tailor treatment plans to better meet the individual needs of patients, helping to improve clinical outcomes for men with mHSPC.”

With this latest approval, darolutamide plus ADT is indicated in China for the treatment of adult patients with mHSPC, either with or without docetaxel. Darolutamide, under the brand name Nubeqa™ is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets around the world, including China. It’s also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world, including China.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARANOTE Trial
The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is radiological progression-free survival (rPFS), measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti- cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of all adverse events (AE), including the incidence of serious and grade 3 and grade 4 AE, in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide's low potential for blood-brain barrier penetration.

Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were similar to the respective comparator arm. With this tolerability profile and a limited risk of potentially critical interactions with other medications, darolutamide offers a very good option in treatment management for physicians and patients.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone-sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Darolutamide is also being investigated in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy.

About Metastatic Hormone-Sensitive Prostate Cancer
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is an advanced form of prostate cancer, when the cancer has spread beyond the prostate to other organs but is still responding to hormone therapy that lowers testosterone, such as androgen deprivation therapy (ADT). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival. ^3,4

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, developing and providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹ Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
² Huang Q, Zi H, Luo L et al. Secular trends of morbidity and mortality of prostate, bladder, and kidney cancers in China, 1990 to 2019 and their predictions to 2030. BMC Cancer. 2022 Nov 11;22(1):1164. doi: 10.1186/s12885-022-10244-9
³ Siegel, DA et al. MMWR Morb Mortal Wkly Rep 2020; 69:1473–1480
⁴ Hahn, A et al. Am Soc Clin Oncol Educ Book. 2018; 23;38:363–371

“The positive CHMP opinion for finerenone in heart failure with mildly reduced or preserved LVEF marks a significant step forward in addressing the high cardiovascular risks of this large and growing group of patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Based on the pivotal FINEARTS-HF study where finerenone showed early, consistent and sustained efficacy across a range of patient profiles and in addition to usual care, we are confident about the potential of finerenone to become a relevant therapy for these patients."

Heart failure is a rapidly growing public health issue affecting over 64 million people worldwide and at least 15 million people in Europe alone. Approximately half of these patients suffer from HF with LVEF of ≥40%, which is frequently associated with multiple comorbidities such as chronic kidney disease, hypertension and atrial fibrillation, contributing to hospitalizations and mortality. Currently, these patients have only limited approved and guideline-directed therapy options, while facing a high risk for cardiovascular events. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. Repeated hospitalizations are a major contributor to heart failure-related costs, which in the EU are estimated at 29 billion Euros annually.

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with left ventricular ejection fraction (LVEF) ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S. In the U.S. and in Japan, finerenone is also approved for the treatment of heart failure with LVEF ≥ 40%. Applications in HF with LVEF ≥ 40% in additional markets, including China, are under review.

The CHMP recommendation is based on the positive results from the pivotal Phase III FINEARTS-HF study, which showed that finerenone significantly reduced the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events, defined as hospitalizations for HF or urgent HF visits, versus placebo in addition to usual therapy. The benefits of finerenone shown in the primary endpoint were consistent regardless of background therapy, comorbidities, or hospitalization status, including patient subgroups based on ejection fraction or baseline use of SGLT2is. The FINEARTS-HF results were presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine. The study is part of the ongoing MOONRAKER program, one of the largest Phase III clinical trial programs to date in heart failure, including over 15,000 patients, which aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies FIND-CKD, FIONA, and FIONA-OLE.

About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 64 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

• Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%
• Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
• Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases 
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“The Supreme Court decision to take the case is good news for U.S. farmers, who need regulatory clarity,” said Bayer CEO Bill Anderson. “It’s also an important step in our multi-pronged strategy to significantly contain this litigation. It is time for the U.S. legal system to establish that companies should not be punished under state laws for complying with federal warning label requirements.” Every leading regulator worldwide has concluded that glyphosate-based herbicides can be used safely.

The Supreme Court previously called for the views of the Solicitor General, who submitted a brief in December on behalf of the United States Government agreeing with the company that the Court should hear the case, resolve the circuit split and rule in the company’s favor.

In his brief, Solicitor General John Sauer argued that upholding the Durnell decision would allow juries to ignore the expert scientific decisions made by the U.S. EPA regarding the safety of glyphosate, saying, "EPA has repeatedly determined that glyphosate is not likely to be carcinogenic in humans, and the agency has repeatedly approved Roundup labels that did not contain cancer warnings….This Court’s intervention is warranted to give FIFRA’s preemption provision its proper force.”

He also warned of the consequences of upholding Durnell, citing a prior Supreme Court holding: writing "where, as here, EPA has specified the health warnings that should appear on a particular pesticide’s label, a manufacturer should not be left subject to ‘50 different labeling regimes prescribing’ different requirements.”

 In its petition, the company argues that a split among federal circuit courts in the Roundup™ litigation warrants review and resolution by the country’s top court. The Third Circuit Court of Appeals unanimously held in Schaffner that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts the plaintiff’s claims which were based on state failure-to-warn theories like those in Durnell. The Ninth and Eleventh Circuits and Missouri’s intermediate appellate court have reached different conclusions, and the petition argues that state and federal courts require guidance that only the U.S. Supreme Court can provide.

In October 2023, Durnell was tried in the Missouri Circuit Court for the City of St. Louis and the jury returned a verdict in favor of the plaintiff on just one of three claims. The jury found the company failed to warn of the product’s risk and awarded 1.25 million US-Dollars, but rejected all other claims and declined to award punitive damages. The company appealed the verdict in August 2024 and the Missouri Court of Appeals, Eastern District upheld the verdict in February 2025. Monsanto promptly filed a writ to transfer the case to the Missouri Supreme Court and it declined review on April 1, making it ripe for U.S. Supreme Court review. Monsanto filed its petition for certiorari just three days later.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact for media inquiries:
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Email: brian.leake@bayer.com

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Email: philipp.blank@bayer.com

Contact for investor inquiries:
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Contact for U.S. investor inquiries:
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Email: erica.mulligan@bayer.com

“Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age. Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. In the Phase III clinical trial QUASAR, Eylea 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a favorable safety profile,” said Richard Gale, Professor of Ophthalmology Hull York Medical School (HYMS), University of York, and Consultant Medical Ophthalmologist, and one of the trial investigators.

In the early treatment phase of RVO, treatment is intensive, with intravitreal injections usually administered in monthly intervals (every 4 weeks). In the QUASAR trial, Eylea 8 mg achieved non-inferior functional and anatomic outcomes compared to Eylea 2 mg, with three times fewer patients requiring monthly intervals (every 4 weeks), despite patients in all treatment arms having the option to extend dosing intervals. Patients treated with Eylea 8 mg (after 3 initial monthly injections) not only maintained their visual acuity but required an average of 2-3 fewer injections than those receiving Eylea 2 mg (8.4 vs. 11.7) by week 64. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with dosing intervals of Eylea 2 mg. The study results also showed that Eylea 8 mg was well tolerated, and its safety profile was consistent with results from previous clinical trials.

“Eylea 8 mg represents a new treatment option for patients with macular edema due to retinal vein occlusion, addressing the demand for more durable therapies. The recent approval in the European Union expands the range of retinal indications for Eylea 8 mg – now encompassing wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

The QUASAR clinical study met its primary endpoint at week 36, demonstrating that patients receiving Eylea 8 mg every 2 months (after 3 or 5 initial monthly injections) achieved non-inferior visual acuity gains and robust fluid control compared to those receiving Eylea 2 mg (aflibercept 2 mg) monthly. Additional submitted data show that visual acuity was maintained with Eylea 8 mg, and unparalleled durability was demonstrated through the end of the study at week 64. More than 60% of patients receiving aflibercept 8 mg were able to achieve a last assigned treatment interval of four months and longer, with 40% having a last assigned interval of five months.

Eylea 8 mg has been approved to date in more than 60 markets for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Eylea 8 mg is the first and only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 6 months both in nAMD and DME in the EU and UK.

Eylea 8 mg (in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.

About RVO
Retinal vein occlusion (RVO) is a chronic condition that currently affects 28 million adults globally and can lead to sudden, rapid vision loss. There are two main types of RVO – central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve. BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. Hemiretinal vein occlusion (HRVO) refers to the occlusion of a vein that supplies one half of the retina. RVO can lead to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein can cause fluid and blood to leak into the retina resulting in swelling and bleeding within the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This swelling is called macular edema, and VEGF plays a major role in driving this pathology.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy / OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor / Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting the results at an upcoming scientific congress

Berlin, November 23, 2025 – Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.

Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.^1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high. One in five stroke survivors will have another stroke within five years.³ Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.^2,4,5

“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families²,” said Mike Sharma, MD, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study, Senior Scientist at PHRI (a joint institute of McMaster University and Hamilton Health Sciences), Director of the Stroke Program at Hamilton Health Sciences, and Michael G. DeGroote Chair in Stroke Prevention at McMaster University. “Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention.”

“We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention. We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”

Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.

About OCEANIC-STROKE 
The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients. The main study results will be presented at an upcoming scientific congress.

About FXIa inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. 

About Bayer’s Commitment in Cardiovascular Diseases
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat cardiovascular diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Our strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

^1.         Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29.

^2.         Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206.

^3.         Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935.

^4.         Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552.

^5.         Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42.

Lynkuet™ (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer

Elinzanetant, now approved in the EU under the brand name Lynkuet™ is a dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and the only hormone-free treatment for moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer / European approval in these two indications is based on positive results from the OASIS Phase III program, comprising four clinical studies (OASIS-1-4), in which elinzanetant significantly reduced the frequency and severity of moderate to severe VMS in women experiencing menopause or receiving endocrine therapy for breast cancer and demonstrated a favorable safety profile

Berlin, November 19, 2025 – The European Commission has granted marketing authorization in the European Union (EU) for elinzanetant, under the brand name Lynkuet™. The compound is approved for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.

“The European approval of Lynkuet™ brings a new option to women whose daily lives are disrupted by vasomotor symptoms,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceutical Leadership Team at Bayer. “We understand how challenging and isolating these symptoms can be, often interfering with daily rhythm, personal productivity, and overall quality of life. Our commitment is to support women with solutions that truly address their needs, helping them feel like them themselves again by supporting health and wellbeing at every stage.”

By 2030, it is estimated that 1.2 billion women globally will be experiencing menopause.¹ VMS affect up to 80% of women during the menopausal transition.² In Europe, approximately 40% of women report moderate to severe VMS,³ highlighting the substantial burden of these symptoms on daily life and overall well-being.

“Menopause symptoms, including hot flashes, can greatly affect women's quality of life,” said Nick Panay, Principal Investigator for OASIS-3, Consultant Gynecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and Immediate Past President of the International Menopause Society. “This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalized treatment.”

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer. Breast cancer remains the most common cancer diagnosed in women worldwide, with approximately 70% of cases categorized as hormone-receptor positive (HR+).^4,5 Endocrine therapy, an established treatment for women with HR+ breast cancer, can often result in VMS^6,7 impacting quality of life and treatment adherence.

“Menopausal symptoms are common side effects of endocrine therapy for breast cancer, frequently leading to treatment discontinuation, which highlights the importance of managing these symptoms in breast cancer care,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon, Portugal. “With the approval of this hormone-free therapy, we now have the first approved treatment option for this indication that will help in addressing an important unmet medical need of women and improve their quality of life during this challenging time.”

The approval of elinzanetant in the EU is based on the positive results from the OASIS Phase III clinical development program, comprising OASIS-1, -2, -3 and -4, which met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile. Data have been published in diverse medical journals: OASIS-1 and –2 in August 2024 in The Journal of the American Medical Association (JAMA)⁸, OASIS-3 in The Journal of the American Medical Association (JAMA) Internal Medicine in September 2025⁹ and OASIS-4 in the New England Journal of Medicine (NEJM) in June 2025.¹⁰

About elinzanetant (Lynkuet^™)
Elinzanetant is the first dual neurokinin (NK)-targeted therapy, (NK-1 and NK- 3 receptor antagonist), globally developed for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation. Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbances.

Elinzanetant is approved under the brand name Lynkuet™ in Australia, Canada, the UK, the U.S., and Switzerland for the treatment of VMS associated with menopause and in the EU for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer. Submissions for marketing authorizations for elinzanetant are also ongoing in other markets around the world.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for treatment or prevention of hormone receptor positive (HR+) breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function usually occurring in their late 40s or early 50s. Menopause symptoms can also be a consequence of surgical or medical treatment such as breast cancer treatment. The most frequently reported and disruptive menopause symptoms are VMS and sleep disturbances, which can substantially affect a woman’s health, quality of life and work productivity. Addressing disruptive menopause symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1      Hill K. The demography of menopause. Maturitas. 1996 Mar 1;23(2):113-27.

2      Gold EB, et al. Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity Across the Menopausal Transition: Study of Women’s Health Across the Nation. American journal of public health. 2006 Jul;96(7):1226-35.

3      Nappi RE, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 Aug 1;28(8):875-82.

4      Breast cancer. World Health Organization. 2024. Available at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer. Last accessed: September 2025.

5      Selli C, et al. Accurate prediction of response to endocrine therapy in breast cancer patients: current and future biomarkers. Breast Cancer Research. 2016 Dec;18:1-0.

6      Burstein HJ, et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. Journal of Clinical Oncology. 2019 Feb 10;37(5):423-38.

7      Cucciniello L, et al. Estrogen deprivation effects of endocrine therapy in breast cancer patients: Incidence, management and outcome. Cancer Treatment Reviews. 2023 Nov 1;120:102624.

8      Pinkerton JV, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024 Oct 22;332(16):1343-54.

9      Panay N, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Internal Medicine. 2025 Sep 8.

10   Cardoso F, et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. New England Journal of Medicine. 2025 Jun 2.

Bayer has also made progress strategically, Anderson noted. Regarding the Pharmaceuticals pipeline, for instance, the company expects to launch Lynkuet™ (active ingredient: elinzanetant), a hormone-free treatment for symptoms associated with the menopause, in the US market this month. Meanwhile, the Crop Science division is focused on executing its Five-Year Framework. Last week, the Plenexos™ insecticide was launched in Latin America, highlighting the division’s focus on innovative crop solutions, Anderson explained. In addition, the company has further reduced its net financial debt, he noted, and Dynamic Shared Ownership is generating returns, with the operating model delivering benefits on the top and bottom line. “Our organization continues to get leaner and more efficient, and we’re seeing benefits in terms of speed and focus.”

Anderson also addressed the litigations in the United States. “We’re convinced our multi-pronged strategy is the right one. As we continue to advance it, we’ll continuously adjust our approaches to resolution.” Bayer is making significant progress, Anderson said, adding that he is confident the company will be able to significantly contain the litigation risk by the end of 2026. “Overall, we know that we have a crucial and highly dynamic phase ahead of us,” Anderson explained. This dynamic is reflected in the company’s provisions, which were adjusted upwards over the past quarter due to a range of factors, he noted. For example, Bayer recently announced that it had reached a number of settlements, and, as expected, this was then followed by a moderate increase in glyphosate case filings. This in turn led to additional provisions and higher litigation costs, as did the negative verdict recently issued by the Washington Supreme Court in the Erickson PCB case. The company will continue to evaluate all options to significantly contain the litigation risk.

Substantial increase in EBITDA before special items and core earnings per share

Group sales came in at 9.660 billion euros in the third quarter of 2025, up 0.9 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). There was a negative currency effect of 447 million euros (Q3 2024: 436 million euros). EBITDA before special items rose by 20.8 percent to 1.511 billion euros, mainly thanks to earnings growth at the Crop Science Division and in the Reconciliation. There was a negative currency effect of 42 million euros (Q3 2024: 94 million euros). EBIT amounted to minus 543 million euros (Q3 2024: minus 3.822 billion euros) after net special charges of 1.064 billion euros (Q3 2024: 4.088 billion euros) that primarily related to allocations to provisions for litigations. Net income amounted to minus 963 million euros (Q3 2024: minus 4.183 billion euros). Core earnings per share more than doubled to 0.57 euros. This increase was likewise partly driven by the growth in earnings at the Crop Science Division and in the Reconciliation.

Free cash flow declined by 48.1 percent to 596 million euros, mainly due to higher settlement payments. This figure is in line with the company’s projections and reflects the seasonality of its business. Net financial debt as of September 30 came in at 32.708 billion euros, representing a reduction of 1.7 percent against June 30, 2025, that was mainly driven by cash inflows from operating activities. Compared to September 30, 2024, net financial debt was down 6.6 percent.

Crop Science benefits from strong corn seed demand

In the agricultural business (Crop Science), sales increased by 1.3 percent (Fx & portfolio adj.) to 3.858 billion euros. The division registered significant gains at Corn Seed & Traits, with sales up 22.4 percent (Fx & portfolio adj.) thanks to higher volumes in all regions. Growth at this strategic business entity was mainly driven by higher planted area in North America and a solid start to the season in Latin America. Business was also up at Herbicides, which saw sales rise 2.8 percent (Fx & portfolio adj.). Growth was primarily fueled by higher volumes for non-glyphosate-based products, while sales of glyphosate-based products came in at the prior-year level (Fx & portfolio adj.). By contrast, the division recorded declines at Soybean Seed & Traits and Insecticides as anticipated, with sales falling 9.6 percent and 9.3 percent (Fx & portfolio adj.), respectively, due to regulatory headwinds impacting Soybean Seed & Traits in the United States and Insecticides in Europe.

EBITDA before special items at Crop Science came in at 172 million euros, representing an almost five-fold increase against the prior year in the third quarter, which is a seasonally low quarter for the agricultural business. Earnings growth was mainly driven by a decline in the cost of goods sold as well as cost savings generated by efficiency programs. By contrast, there was a negative currency effect of 21 million euros (Q3 2024: positive currency effect of 32 million euros). The EBITDA margin before special items rose by 3.6 percentage points to 4.5 percent.

Pharmaceuticals records further gains for Nubeqa™ and Kerendia™

Sales of prescription medicines (Pharmaceuticals) came in at 4.335 billion euros, up 0.4 percent (Fx & portfolio adj.). The division again registered significant gains for Nubeqa™, for the treatment of prostate cancer, and Kerendia™, for the treatment of chronic kidney disease associated with type 2 diabetes, as well as heart failure. Sales of these two products rose by 56.2 percent and 85.4 percent (Fx & portfolio adj.), respectively. Sales of the long-term contraceptives in the Mirena™ product family also advanced substantially, with an increase of 22.9 percent (Fx & portfolio adj.) that was primarily driven by gains in the United States, where business benefited from a special order. In addition, the Radiology business posted considerably higher sales thanks to increased volumes and prices, especially for Ultravist™ and CT Fluid Delivery. By contrast, business headwinds mainly related to declines for Xarelto™ and Eylea™. Sales of the oral anticoagulant fell by 31.4 percent (Fx & portfolio adj.) due to patent expirations, while the ophthalmology drug saw a decline of 11.2 percent (Fx & portfolio adj.) that was primarily attributable to lower prices and competitive pressure from generics. Eylea™ sales were also negatively impacted by phasing into the fourth quarter in Japan. In addition, the prior-year quarter had benefited from a positive one-time effect arising from a reimbursement in the United Kingdom. The division nonetheless continues to target stable full-year Eylea™ sales versus the prior year.

EBITDA before special items at Pharmaceuticals declined by 5.2 percent to 1.045 billion euros. Earnings were mainly impacted by a negative currency effect of 46 million euros (Q3 2024: 134 million euros) and an increase in R&D expenses that was partly attributable to higher investments in early-stage research and in cell and gene therapy and chemoproteomics technologies. In addition, negative pricing developments in connection with patent expirations and the Inflation Reduction Act in the United States were only partially offset by a strong increase in volumes. By contrast, earnings benefited from cost savings generated by efficiency programs as well as lower allocations to provisions for the Group-wide short-term incentive (STI) program. The EBITDA margin before special items decreased by 0.3 percentage points to 24.1 percent.

Consumer Health posts moderate sales growth (Fx & portfolio adj.)

Sales of self-care products (Consumer Health) increased by 2.0 percent (Fx & portfolio adj.) to 1.415 billion euros. Growth was held back by an increasingly challenging environment in key markets in North America and Asia/Pacific. Business was mainly up in the Dermatology, Digestive Health and Pain & Cardio categories, with gains of 7.0 percent, 6.5 percent and 6.5 percent (Fx & portfolio adj.), respectively. By contrast, sales at Allergy & Cold were down 7.8 percent (Fx & portfolio adj.).

EBITDA before special items at Consumer Health came in at 363 million euros, representing an increase of 0.8 percent against the prior-year level. Earnings benefited from the increase in sales as well as the division’s continuous cost management efforts, which primarily resulted in lower selling expenses. By contrast, the division registered a negative currency effect of 25 million euros (Q3 2024: positive currency effect of 7 million euros) and an increase in the cost of goods sold. The EBITDA margin before special items rose by 0.2 percentage points to 25.7 percent.

Group guidance for 2025 confirmed

Based on the company’s solid business performance overall in the first nine months of the year, Anderson confirmed the upgraded full-year Group guidance that was published in the 2025 Half-Year Financial Report. For Consumer Health, Bayer now projects currency- and portfolio-adjusted sales growth of minus 1 to plus 1 percent as the division navigates an increasingly challenging market environment. The company had previously expected currency- and portfolio-adjusted sales growth at the division to come in at the lower end of the projected range of 2 to 5 percent. However, it does not anticipate any impact with respect to its guidance for the division’s EBITDA margin before special items. In view of the additional allocations to provisions for litigations in the third quarter, Bayer now expects special items in full-year Group EBITDA to come in at minus 4.0 to minus 3.5 billion euros (previous forecast: minus 3.5 to minus 2.5 billion euros), and special items in full-year Group EBIT to come in at minus 3.0 to minus 2.5 billion euros (previous forecast: minus 2.5 to minus 1.5 billion euros).

Looking ahead, Chief Financial Officer Wolfgang Nickl outlined Bayer’s prospects for 2026, including some comments on the main known business drivers for next year for the three divisions. For example, he pointed to product launches and patent expirations at Pharmaceuticals. Regarding Crop Science, Nickl said: “While the agricultural market outlook remains quite dynamic, we look forward to bringing innovation to farmers and pursuing our profitability goals.” For Consumer Health, he added: “Following some challenges in key markets this year, we see the general market growth trends intact.” The company expects significant currency headwinds to continue in 2026. “Overall, we’re fully focused on effectively managing what we control, adjusting to new realities quickly and advancing in our transformation,” said Nickl. The company will provide specific guidance with the full-year 2025 results at the end of February next year.

Notes:

The following tables contain the key data for the Bayer Group and its divisions for the third quarter and the first nine months of 2025.

The full quarterly statement for the third quarter is available online at: www.bayer.com/quarterly-statement

The speech given by Bill Anderson and Wolfgang Nickl to the media will be available online from around 10 a.m. CET at: www.bayer.com/speeches

Live broadcast of the Media Update from around 10 a.m. CET and recording available from around 1 p.m. CET at: www.bayer.com/live-mc

Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CET) and recording (from around 6 p.m. CET) available at: www.bayer.com/live-ic

Print-quality photos can be found online at: www.bayer.com/photo-footage

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

“With Judith Hartmann, Bayer is gaining a highly accomplished leader with vast international experience. She brings both strategic insight and strong operational skills. Throughout her career, she has demonstrated transformational leadership – guiding businesses through challenges and discovering new opportunities. We are convinced that she will make a great contribution to the future of the company,” said Professor Dr. Norbert Winkeljohann, Chairman of the Supervisory Board of Bayer AG. “Wolfgang Nickl has built a strong foundation over the past seven years as CFO. Under his leadership, the structure and operations have been dramatically simplified with further improvements in the effectiveness of the organization and extensive efficiency gains. We are very grateful for this.”

Dr. Judith Hartmann studied at the Vienna University of Economics and Business, where she received a master’s degree in business administration, and a Ph.D. in Economics in 1997. She joined The Walt Disney Company in Paris, before moving to General Electric (GE) in 2000, where she worked in roles of increasing responsibility in both financial and operational capacities across the USA, Europe and Latin America, including positions with GE’s healthcare and energy divisions. In 2012 Dr. Hartmann was appointed Group CFO at Bertelsmann. She joined ENGIE in 2015, where she held several leadership positions, including Deputy CEO and Group CFO, later also serving as interim Co-CEO. In addition to her global responsibilities, she also oversaw ENGIE’s regional operations in North America and the UK & Ireland. In 2023 she took on her current role of Operating Partner at Sandbrook Capital.

Alongside her executive roles, Dr. Hartmann is an accomplished Non-Executive Director of several large companies. She served on the Board of Unilever, a global consumer goods company, from 2015 to 2024 and joined the Board of Directors of Marsh McLennan, a global professional services company, in 2023. In 2025 she joined the Board of Ørsted, the world’s largest offshore wind energy company. She was also a Non-Executive Director at Suez from 2015 to 2020, and rejoined the Board in 2023 after the company’s privatization. Earlier in her career she was on the Boards of RTL Group, as well as Electrabel, International Power, Penguin Random House and Gruner & Jahr.

Outside of her professional life, Dr. Hartmann is a skilled mountaineer, including high-altitude expeditions, and proficient skier. She is also active in the arts, with a focus on painting and supporting artists.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes

Finerenone is the first medicine in over 30 years to provide positive results in a Phase III study addressing the high risk of kidney disease progression and cardiovascular events in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D) / In the global FINE-ONE Phase III study, finerenone significantly reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline (ratio to baseline) over 6 months compared to placebo / CKD associated with T1D is a major public health challenge: 30% of people with T1D develop CKD, and CKD associated with T1D significantly increases the risk of kidney failure and cardiovascular events, contributing to CKD being a leading cause of death in T1D / Treatment options in people with CKD associated with T1D are limited, and residual risk remains high in these patients despite guideline-recommended therapies to control hyperglycemia, hypertension, and albuminuria

Berlin, November 6, 2025 – Bayer today announced results from the pivotal Phase III FINE-ONE study, demonstrating that finerenone (Kerendia™/ Firialta™) in addition to standard of care is superior to placebo in showing a statistically significant reduction in urine albumin-to-creatinine ratio (UACR) from baseline (ratio to baseline) over 6 months in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Elevated UACR is associated with a higher risk of kidney disease progression and kidney failure, and is a predictor of cardiovascular events. Reduction of UACR with finerenone in the pivotal Phase III studies in CKD in type 2 diabetes (FIDELIO-DKD, FIGARO-DKD) was strongly associated with delay of kidney disease progression and kidney failure, as well as with a reduction of cardiovascular events. The FINE-ONE findings were presented today as “Featured High-Impact Clinical Trial” during the Opening Plenary session of the American Society of Nephrology’s (ASN) Kidney Week 2025.

“Patients living with type 1 diabetes and chronic kidney disease face an increased risk of kidney failure and cardiovascular disease, impacting quality of life and life expectancy,” said Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Chair of the study’s Steering Committee. “UACR reduction is highly correlated with a reduction in kidney and cardiovascular events. The positive results of the FINE-ONE study represent a landmark moment and give hope to patients with chronic kidney disease associated with type 1 diabetes who currently have very limited treatment options.”

 In FINE-ONE, finerenone significantly reduced the primary endpoint of relative change in UACR by 25% (percentage reduction, least squares geometric mean (LSGM) ratio 0.75 [95% CI, 0.65-0.87; p=0.0001]) from baseline over 6 months versus placebo. At any time post-baseline, 81 out of 119 participants (68.1%) in the finerenone arm, versus 54 out of 116 participants (46.6%) in the placebo arm achieved at least a 30% reduction in UACR, a threshold established by the American Diabetes Association (ADA) as being associated with slower CKD progression in patients with CKD associated with type 2 diabetes. Based on the outcome of FINE-ONE, the non-steroidal mineralocorticoid receptor antagonist (nsMRA) finerenone is the first medicine since the 1990s to provide positive results in a Phase III study addressing the high risk of kidney disease progression and cardiovascular events in patients with CKD associated with T1D.

"People with type 1 diabetes and chronic kidney disease face an immense burden due to their increased risk for both kidney and cardiovascular events," said Jonathan Rosen, PhD, Research Director at Breakthrough T1D, the leading global type 1 diabetes research and advocacy organization. "Breakthrough T1D remains committed to collaborating with Bayer to improve kidney care for people with type 1 diabetes."

CKD affects 30% of people with T1D and approximately one in four of these individuals will progress to end-stage kidney disease. In 2025, more than 9.5 million people are living with T1D worldwide, with prevalence projected to rise to between 13.5 - 17.4 million in 2040. People with both T1D and CKD face a significantly increased risk of kidney failure and cardiovascular disease (CVD). In the U.S., 1.4 million adults aged 20 years or older are living with type 1 diabetes, representing 5.2% of all US adults with diagnosed diabetes. More than half of new T1D diagnoses in the U.S. occur in people aged 20 and older, and around 85% of these cases arise in people with no known family history of the condition.

“UACR is an important predictor of kidney and cardiovascular events in chronic kidney disease associated with diabetes, with elevated levels indicating worsening kidney damage. For more than three decades, no kidney-specific disease modifying therapies have been approved in chronic kidney disease associated with type 1 diabetes,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “Finerenone has demonstrated its ability to reduce UACR in patients with CKD associated with T1D, and we are excited about the prospect of offering a potential new treatment option for these patients, whose condition has been under-researched for so long.”

The results of the FINE-ONE study are consistent with and add to the robust body of evidence of finerenone, showing a significant reduction in UACR over 6 months. There is a strong association between elevated UACR (albuminuria) and kidney disease progression in both types of diabetes, and UACR reduction is highly correlated with a reduction in kidney and cardiovascular events. Data from the FIDELITY pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD studies in patients with CKD associated with type 2 diabetes showed that more than 80% of the kidney benefit of finerenone was explained by UACR reduction. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors.

Finerenone was well-tolerated in the FINE-ONE study, which is consistent with the well-established safety profile of finerenone. No new safety signals were identified. The overall incidence of treatment-emergent serious adverse events was comparable between finerenone and placebo groups. Hyperkalemia-related adverse events occurred more frequently with finerenone than placebo (in 12 patients or 10.1% in the finerenone arm, versus in 4 patients or 3.3% in the placebo arm, respectively). There were no fatal adverse events of hyperkalemia in either treatment group, and the rate of hospitalization or discontinuation due to hyperkalemia was low.

Bayer plans to provide the data to health authorities for regulatory assessment of finerenone for the treatment of CKD associated with T1D in due course.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in the U.S.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies FIND-CKD, FIONA, and FIONA-OLE.

About FINE-ONE
In FINE-ONE, 242 participants were randomized from more than 80 sites across 9 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

In FINE-ONE, finerenone significantly reduced the primary endpoint of relative change in UACR by 25% (percentage reduction, least squares geometric mean (LSGM) ratio 0.75 [95% CI, 0.65-0.87; p=0.0001]) from baseline over 6 months versus placebo. At any time post-baseline, 81 out of 119 participants (68.1%) in the finerenone arm, versus 54 out of 116 (46.6%) participants in the placebo arm achieved at least a 30% reduction in UACR, a threshold established by the American Diabetes Association (ADA) as being associated with slower CKD progression in patients with CKD associated with type 2 diabetes. The safety profile of finerenone in FINE-ONE was consistent with previous studies and no new safety signals were identified.

FINE-ONE is a global, randomized, placebo-controlled, double-blind, multicenter Phase III study in people with CKD and T1D. The primary objective was to demonstrate whether the addition of finerenone to standard of care is superior to placebo in reducing UACR from baseline over six months. Secondary endpoints included the number of participants with treatment emergent adverse events and hyperkalemia (adverse event of special interest).

Participants were randomly assigned 1:1 to finerenone (10 or 20 mg OD) or a finerenone-matched placebo. The starting dose depended on estimated glomerular filtration rate (eGFR) level (10 mg for eGFR ≥25–<60 mL/min/1.73 m²; 20 mg for eGFR ≥60 mL/min/1.73 m². Finerenone was uptitrated to the 20 mg target dose after 30 days if the serum/plasma [K+] is ≤4.8 mmol/L and the eGFR decrease is <30% compared with the value measured at the prior visit. Safety was assessed at all scheduled visits, including serum potassium determined both centrally and locally. Blood pressure was assessed at screening and all follow-up visits. UACR was assessed at screening, baseline, month 3, month 6 and at the follow-up visit one month post treatment.

About Chronic Kidney Disease associated with Type 1 Diabetes
Type 1 Diabetes (T1D) is a chronic autoimmune disorder characterized by destruction of pancreatic beta cells leading to insulin deficiency and requiring lifelong insulin treatment. Among the US population overall, crude estimates for 2018 indicated that 1.4 million adults aged 20 years or older (or 5.2% of all US adults with diagnosed diabetes), reported both having T1D and using insulin.

CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.

CKD affects 30% of people with T1D. In a systematic analysis for the Global Burden of Disease study, it was reported that the prevalence of CKD associated with T1D had increased by 58.2% from 1990 to 2007 and by 21.7% from 2007 to 2017. The 2017 global prevalence of CKD due to T1D was an estimated 32.5 per 100,000 individuals.

The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in kidney function as measured by estimated glomerular filtration rate (eGFR). The treatment of T1D consists of insulin treatment to control hyperglycemia. In people with T1D, blood glucose intervention targeting HbA1c levels ≤7% can slow onset and progression of kidney disease. Despite guideline-recommended treatment with ACEIs and ARBs, residual risk remains high in people with CKD and T1D, with up to a quarter progressing to end-stage-kidney-disease. CKD associated with T1D significantly increases the risk of cardiovascular events and kidney failure, contributing to CKD being a leading cause of death in T1D.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases 
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The company disagrees with the Supreme Court’s decision to reverse the Court of Appeals in Erickson and deny Monsanto’s cross-petition regarding the availability of punitive damages. In particular, the company believes that the Court’s choice-of-law analyses underlying its rulings on punitive damages and the statute of repose are wrong and contrary to the U.S. Constitution because the rulings unlawfully discriminate against out of state companies doing business in Washington. Three dissenting justices found in favor of the company on its entitlement to a statue of repose defense under Washington law, writing: ‘…courts are not supposed to start their analysis with policy preferences when there’s a state statute right on point.’ The company is considering its legal options.

Erickson was the first case involving allegations of PCB exposure at SVEC to go to trial in 2021. On appeal, the intermediate appellate court vacated the judgment and reversed the trial court on three cross-cutting issues in the litigation. Plaintiffs then filed an appeal with the state Supreme Court and Monsanto cross-petitioned on punitive damages, arguing that Washington’s Product Liability Law under which this and subsequent cases were tried does not permit them.

The company has appeals or post-trial motions pending in eight other SVEC cases. These actions raise additional questions of law beyond those at issue in Erickson and will move forward through the appellate process. Each case is unique and has its own factual and legal record. Examples of the range of issues raised in these other cases include the application of Missouri’s offset statute for punitive damages—which generally prohibits punishing a defendant more than once for the same conduct—along with due-process limits on punitive damages; the trial courts’ exclusion of evidence of alternative causes and pre-existing conditions for the injuries at issue; and the courts’ refusal to instruct the jury on superseding cause.

In August, the company announced it had reached agreements in principle to resolve all SVEC cases, except Erickson and eight other prior adverse verdicts which remain on appeal. The terms of the agreements in principle are confidential. The company is confident in its legal strategy and prepared to defend itself at trial but will consider resolving cases when it is strategically advantageous to do so.

Monsanto also has a case pending in Missouri to enforce its indemnity agreements with former purchasers of PCBs who manufactured electrical equipment in order to recover legal costs, settlements and judgments.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause

This approval is supported by data from the Phase III OASIS clinical program evaluating Lynkuet™ (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes), due to menopause1 / In OASIS 1 and 2, elinzanetant met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1 / Hot flashes are a common symptom of menopause2 and one of the main reasons women seek treatment3, hot flashes may impact women differently4 and some can be disruptive5 / Elinzanetant is the first dual neurokinin (NK) targeted therapy,1 NK1 and NK3 receptor antagonist

Berlin, October 24, 2025 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved elinzanetant as the first dual neurokinin (NK) targeted therapy¹, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, under the brand name Lynkuet™ for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) due to menopause. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons with elinzanetant can modulate neuronal activity in the thermoregulation associated with hot flashes.¹ The FDA approval is supported by data from three Phase III clinical studies (OASIS 1, OASIS 2 and OASIS 3) that evaluated the efficacy and safety of elinzanetant for the treatment of moderate to severe VMS due to menopause.

“For more than a century, Bayer has been dedicated to pioneering advances in women’s health, and this FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “There is a need for more individualized approaches to menopause care, and Lynkuet™ addresses a significant gap in treatment options. The approval in the U.S. reflects our unwavering commitment to delivering science-driven solutions that meet women’s evolving healthcare needs and empower them to take charge of their health at every stage of life.”

The efficacy of elinzanetant for the treatment of moderate to severe VMS due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women.¹ The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe VMS from baselines to weeks 4 and 12, including day and night hot flashes.¹ The safety of elinzanetant was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2 and OASIS 3) in 1420 women. In OASIS 3, 627 women received elinzanetant or placebo for up to 52 weeks to evaluate long-term safety.¹

“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.” 

Hot flashes are a common symptom of menopause² that may impact women differently⁴. Hot flashes can be disruptive⁵ and are a common reason for which women in menopause seek treatment³.

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” said Claire Gill, President and Founder of the National Menopause Foundation.

Elinzanetant is expected to be available in the U.S. beginning in November 2025.

About elinzanetant
Elinzanetant is the first dual neurokinin (NK) targeted therapy,¹ neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, approved in the U.S. for the treatment of moderate to severe VMS due to menopause.¹ 

The compound is being developed globally for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation. Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbance.

Elinzanetant has been approved under the brand name Lynkuet™ in the U.S. as well as in Australia, Canada, the UK, and Switzerland. It is pending approval in the European Union and under review in other markets around the world.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. Menopause symptoms can also be a consequence of surgical (such as bilateral oophorectomy) or medical treatment (such as endocrine therapy for breast cancer). The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.^6-8Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

¹LYNKUET^® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2025
²Thurston, R. C., & Joffe, H. (2011). Vasomotor symptoms and menopause: Findings from the Study of Women's Health across the Nation. Obstetrics and Gynecology Clinics of North America, 38(3), 489–501. https://doi.org/10.1016/j.ogc.2011.05.006.
³Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr. 2010;140(7):1380S-5S.
⁴Shepherd JA, Shiozawa A, Schild AL, Singh D, Mancuso SA. Retrospective text and qualitative analyses of patient experience and management of vasomotor symptoms due to menopause: voices from the PatientsLikeMe community. Menopause. 2024 Sep 1;31(9):789-795. doi: 10.1097/GME.0000000000002391. Epub 2024 Jul 8. PMID: 38980735; PMCID: PMC11469626.
⁵US Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy. Accessed October 23, 2025.
⁶Thurston & Joffe, Obstet Gynecol Clin North Am. 2011 September ; 38(3): 489–501.
⁷Thurston, Climacteric 2018 April; 21(2): 96-100 6. Thurston RC et al, Sleep. 2019;42(9)
⁸.Utian, W.H. Health Qual Life Outcomes 3, 47 (2005)

“Our dual approach in addressing Parkinson’s disease through both cell and gene therapies exemplifies our strategic vision and maximizes our chances of offering renewed hope for Parkinson’s patients who have been waiting for new therapies for too long,” said Christian Rommel, Global Head of Research and Development of Bayer’s Pharmaceutical Division. “We are energized by being at the forefront of the development of disease modifying therapies that have the potential to make a meaningful impact on Parkinson’s patients lives.”

Bayer is setting a global benchmark in the development, manufacturing, and commercialization of cell and gene therapies based on the establishment of a comprehensive end-to-end approach that covers the entire spectrum from research to production and includes state-of-the-art production facilities worldwide.

“Parkinson’s disease is characterized by the loss of dopamine producing cells in the brain resulting in motor impairments,” said Gabi Belfort, MD, PhD, Senior Vice President and Bemdaneprocel Product Lead at BlueRock Therapeutics. “Bemdaneprocel aims to replace these lost cells with new dopamine producing neurons and we are excited that the pivotal Phase III exPDite-2 clinical trial to explore this approach is now underway.”

“We believe there is a significant need for neurorestorative therapies in Parkinson’s, and AskBio is committed to exploring the potential of investigational gene therapy AB-1005 in the treatment of this severe, progressive chronic disease,” said Adrian Kells, PhD, Senior Vice President, Integrated Product Team Lead, Parkinsons and MSA, at AskBio. “We are excited to share the news of the advancement of our REGENERATE-PD clinical trial in Europe, which we believe is an important update for patients and the medical community.”

Bemdaneprocel and AB-1005 are investigational therapies which have not been approved by any regulatory authority, and their efficacy and safety have not been established or fully evaluated. 

About Parkinson’s Disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack the holistic management of symptoms so there is an urgent need for new therapies.

About Bemdaneprocel (BRT-DA01)
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.

About exPDite-2
exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson’s disease. In a Phase I study with 12 participants, bemdaneprocel was well tolerated, with no serious adverse events related to drug product at 24 months post-surgery. In addition, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson’s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life. For more information about the exPDite-2 clinical trial, visit clinicaltrials.gov (NCT06944522), or visit bluerocktx.com.

Depending upon the outcome, the results from this trial are intended to be part of a data package to support regulatory submissions for marketing authorization.

About AB-1005
AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery. In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons. Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as PD, marked by progressive degeneration of midbrain dopaminergic neurons. Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, one can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.

About REGENERATE-PD
REGENERATE-PD is a Phase II, randomized, double-blind, surgery controlled trial of the efficacy and safety of intraputaminally administered investigational gene therapy AB-1005 in the treatment of adults (45–75 years) with moderate-stage Parkinson’s disease. The trial will include an estimated 87 participants with trial sites located in Germany, Poland, the United Kingdom, and the United States. For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (NCT06285643), or visit askbio.com.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

By focusing on the “translation” of medicine, the Berlin Center for Gene and Cell Therapies aims to accelerate the rate at which groundbreaking technologies are translated from basic research into treatment options more quickly. Gene and cell therapies bring hope to people when conventional therapies have failed or when no effective treatment options exist.

This initiative aims to create a biotech ecosystem which supports start-ups to bring their novel therapeutic approaches into clinical development. The center is significantly funded by the Federal Ministry of Education and Research as well as the State of Berlin.

Since the project’s launch in June 2024, Charité and Bayer have welcomed the Berlin Institute of Health (BIH) as an additional partner. Today, together with project developer iQ spaces, the three partners participated in a groundbreaking ceremony for a new building that will serve as the centerpiece of the project.

At Berlin’s Nordhafen, a state-of-the-art building with approximately 20,000 m² is being constructed to house the BC GCT. Among the tenants will be Bayer Co.Lab, Bayer's start-up incubator that has been supporting biopharma startups since 2024 with fully equipped labs, offices, expertise, and networks. With its relocation and expansion in 2028, Bayer Co.Lab will contribute its experience to the new project and the community that is taking shape around it.

The BC GCT will feature an incubator with fully equipped laboratory and office space, providing room for 15 to 20 start-ups at various stages of development. An additional aspect is a facility certified by Good Manufacturing Practice (GMP) production facility for the development of gene and cell therapies up to clinical phase II.

The architectural firm HENN has been commissioned with the general planning. The incubator will be operated by Gene and Cell Therapies Incubator Berlin GmbH, which Charité and Bayer founded specifically for this purpose. BIH has commissioned the Berlin-based CDMO ProBioGen AG to operate the GMP facility. The Berlin Center for Gene and Cell Therapies is scheduled to open in 2028.

Comments on the groundbreaking ceremony

Lars Klingbeil, Federal Minister of Finance: "We are investing in growth and innovation. In doing so, we are focusing specifically on future-oriented industries such as biotech. The Berlin Center for Gene and Cell Therapies supports startups in bringing innovative treatments directly to patients – while also creating high-quality jobs with strong prospects for the future in Germany."

Dorothee Bär, Federal Minister of Research, Technology, and Space: The groundbreaking ceremony today for the Berlin Center for Gene and Cell Therapies demonstrates a successful public-private partnership between Charité, the Berlin Institute of Health, Bayer AG, and ProBioGen AG, and serves as an exemplary model for Germany's High-Tech Agenda. The Berlin Center for Gene and Cell Therapies brings together researchers and entrepreneurs, thereby enabling real innovations. This also signifies that the National Strategy for Gene and Cell Therapies has become a reality. This not only brings new momentum to the biotech sector in Germany but also offers hope to a large number of patients and those affected by severe and rare diseases.

Kai Wegner, Governing Mayor of Berlin: "Our goal is clearly defined: we want to create a ‘Boston on the Spree’ – and develop novel, future-ready therapies for patients here in Berlin in a biotech center. The translation Center for Gene and Cell Therapies is the first essential building-block of a Life Science Campus in the heart of Berlin, at which science and research, start-ups and established companies will work on the future of medicine. With the ground-breaking ceremony for the new biotech center, two top players in the health economy – Charité and Bayer AG – have shown an impressive commitment to Berlin as a science, innovation and technology location.”

Franziska Giffey, Mayor and Senator for Economics, Energy, and Public Enterprises of the State of Berlin: "This groundbreaking ceremony is a milestone for a flagship project that will have an impact far beyond Berlin! It sends a clear signal about the future of medicine in Berlin and strengthens Germany's position in the global biotech competition. Work is being done here to better diagnose, treat, and, in the best case, cure previously incurable diseases. This means hope for patients and a boost for our city's healthcare industry. The close cooperation between science, industry, and start-ups demonstrates the strengths of Berlin's ecosystem. My thanks go to everyone who is working tirelessly for the success of this project—together, we are securing Berlin's place as Europe's leading innovation metropolis."

Dr. Henry Marx, State Secretary for Science and Research of the State of Berlin: "With the new Berlin Center for Gene and Cell Therapies, we are further expanding Berlin's position as one of Europe's most important science locations. The project impressively demonstrates how groundbreaking research is being conducted here, from basic research to therapy for patients – all under one roof. This proves once again that when it comes to medicine and life sciences - Berlin is leading the way."

Stefan Oelrich, member of the Board of Management of Bayer AG and Head of the Pharmaceuticals Division: "The groundbreaking ceremony of the new building for the Berlin Center for Gene and Cell Therapies and the Berlin Co.Lab is a signal that Germany wants to play a leading role in the key technologies of the 21st century as an innovation and industrial location. Our goal is for startups 'Made in Germany' to grow locally and for globally successful therapy options to continue to be developed in Germany. The public-private partnership between Charité, the Berlin Institute of Health, and Bayer demonstrates how crucial collaborative engagement is to fully unleash the potential of transformative technologies – for the benefit of patients worldwide."

Prof. Heyo K. Kroemer, Chairman of the Executive Board of Charité: "With gene and cell therapies, we are pushing the boundaries of what is medically possible. By bringing together both research and production of these highly innovative drugs under one roof, the Berlin Center for Gene and Cell Therapies shortens the path from the experimental stage to application. In this way, we are ensuring that patients benefit from significant medical advances as quickly as possible. With this center, Charité is fulfilling its responsibility as a university hospital while also strengthening Berlin's profile as an internationally visible biomedical location."

Prof. Christopher Baum, Chairman of the BIH Executive Board and Director of Translational Research at Charité: " With the groundbreaking ceremony of BC GCT, the National Strategy for Gene and Cell-Based Therapies is becoming a reality: With the help of funding from the Federal Ministry of Education and Research, which amounts to €76.5 million over the next 10 years, we are building a state-of-the-art GMP facility for the production of gene and cell therapeutics within the center. We are delighted to have found a competent and experienced partner in the Berlin-based company ProBioGen AG for the construction and operation of the GMP facility. This will enable us to set new standards for the safe and sustainable manufacture of pharmaceutical products and bring research directly into application."

About gene and cell therapies
Gene and cell therapies (Advanced Therapy Medicinal Products, ATMPs) are among the most important innovations in healthcare. They have the potential to fundamentally transform the treatment of cancer, autoimmune diseases, neurodegenerative diseases, and many rare genetic diseases. These novel therapies are based on genes, tissues, or cells and therefore often contain living components. These products, also known as "living drugs," can be tailored to individual patients more effectively than traditional medicines and are particularly suitable for treating diseases that were previously untreatable or difficult to treat. Although hundreds of clinical trials are underway to develop gene and cell therapies, only a few products have been approved in Europe to date. Bridging this translation gap is the goal of the Berlin Center for Gene and Cell Therapies, a joint initiative of Charité and Bayer.

About the Berlin Center for Gene and Cell Therapies (BC GCT)
The Berlin Center for Gene and Cell Therapies is an innovative public-private partnership that brings together research, development, and production of gene and cell therapies under one roof. The initiative was launched by Bayer AG, Charité – Universitätsmedizin Berlin, and the Berlin Institute of Health at Charité. With an incubator for start-ups that can host 15 to 20 companies, as well as a GMP-certified manufacturing facility, the center creates optimal conditions for the translation of novel therapies from the lab to clinical application. Funding from the State of Berlin and the Federal Ministry for Research, Technology, and Space supports the expansion of the infrastructure and ensures the long-term quality and safety of medicinal products. The GMP facility is operated by ProBioGen AG, ensuring compliance with international quality standards. The building is being developed by iQ spaces as project developer and is in proximity to the Bayer campus in Berlin, with completion scheduled for 2028.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

About Charité – Universitätsmedizin Berlin
With more than 100 departments and institutes across four campuses and 3,293 beds, Charité – Universitätsmedizin Berlin is one of Europe’s largest university medical centers. At Charité, the areas of research, teaching, and medical and patient care are closely interconnected. Averaging about 20,600 employees Charité-wide and some 24,300 across the entire group of companies, Berlin’s university medicine organization remained one of the capital city’s largest employers in 2024. Charité is a leader in diagnosis and treatment of particularly severe, complex, and rare diseases and health conditions. A medical school and university medical center in one, Charité enjoys an outstanding reputation worldwide, combining first-class patient care with excellence in research and innovation, state-of-the-art teaching, and high-quality training and education. Everything Charité does revolves around people and their health. Charité pursues translational research in which scientific findings are applied to prevention, diagnostics, and treatment and clinical observations inform new approaches in research in turn. At Charité, the goal is to actively help shape the medicine of the future to benefit patients. https://www.charite.de/en/

About the Berlin Institute of Health at Charité (BIH)
The Berlin Institute of Health at Charité (BIH) is dedicated to biomedical translation. Its mission is to translate research findings into personalized prevention, diagnostics, and therapies to benefit patients and provide the scientific community with effective tools. With approximately 750 employees, the BIH specializes in translational method development, precision medicine, regenerative therapies, and biomedical data science.  Closely integrated with Charité, the BIH promotes excellent research and facilitates the accelerated transfer of new discoveries into clinical practice through its supporting platforms and programs. Through these efforts, the BIH builds strong partnerships and fosters innovation-driven medicine in both national and international context.

Links

Photos from the event (© Bayer & Charité | Norbert Ittermann; Picture to follow as soon as possible) https://www.picdrop.com/norbertittermann/6RFv7ZP7X2 

Berlin Center for Gene and Cell Therapies 

Gemeinsam für Innovation: Charité und Bayer gründen Berlin Center for Gene and Cell Therapies (Pressemitteilung vom 21. Juni 2024) 
Gen- und Zelltherapien: Charité und Bayer gründen gemeinsame Gesellschaft (Meldung vom 4. Dezember 2024) 
Nationale Strategie für gen- und zellbasierte Therapien 

Find more information at https://pharma.bayer.com 
Follow us on Facebook: http://www.facebook.com/bayer 

Follow us on Twitter: @BayerPharma 

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries :

Bayer
Ulrike Schröder, phone +49 30 4681 92206
E-Mail: ulrike.schroeder@bayer.com

Charité:  
Markus Heggen, phone +49 30 450 570 400
E-Mail: markus.heggen@charite.de

BIH
Mirjam Kaplow, phone +49 30 450 543 343, mobile +49 162 7247266
E-Mail: mirjam.kaplow@bih-charite.de

The terms of the agreements in principle are confidential and subject to approval of final settlement agreements by the parties. The cost of the additional settlements is covered by the PCB litigation provision taken in Q2, which also covers the previously announced settlement of the Burke case as well as other PCB-related litigation costs. While the company remains confident in its legal strategy and defenses, and is fully prepared to defend cases at trial, it has maintained it will consider resolving cases on appropriate terms when it is strategically advantageous to help mitigate the risks and uncertainties of this litigation. The company continues to pursue a multi-pronged strategy to significantly contain the risks of this litigation by the end of 2026.

The adverse jury decisions in nine prior cases (49 plaintiffs) remain under appeal and are not included in the settlement agreements. Each of these cases has its own unique factual and legal record, and all of these appeals raise additional questions of law that are not before the Washington State Supreme Court in Erickson, a case that is still pending.

The company filed a complaint in Missouri to enforce its rights under indemnity contracts signed in 1972 by its largest, former electrical manufacturing customers. Under these agreements, these former customers agreed to fully defend and indemnify Monsanto as a condition of continuing to receive bulk PCBs for use in their closed-end finished products.

Widely recognized as nonflammable safety fluids, PCBs were once specified by many electrical and building codes and insurance companies to protect against serious fire risk, and their production was required by the federal government to protect the nation’s electrical grid. In 1972, the Interdepartmental Task Force on PCBs, comprised of eight federal agencies and sub-agencies, including EPA, found that continued manufacture and sale of PCBs for certain electrical applications was necessary. Monsanto voluntarily ceased all PCB production in 1977.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact for media inquiries:
Brian Leake, phone +1 314-370-3285
Email: brian.leake@bayer.com

Philipp Blank, phone +49 214 30-20499
Email: philipp.blank@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Bayer issued an advance update on Thursday, July 31, in which it provided information on key financial performance indicators for the second quarter and upgraded its full-year guidance for currency-adjusted sales and earnings. As part of that communication, it also reported an increase in provisions and liabilities for litigation in the United States.

“We affirm our objective to significantly contain the litigation risk by the end of 2026,” Anderson noted on Wednesday. As part of its multi-pronged strategy, the company continues to press ahead at full speed as it looks to limit its exposure to the litigation industry, he added. As previously reported, Bayer recognized approximately 1.2 billion euros in additional provisions for glyphosate and approximately 530 million euros in provisions and liabilities for PCBs in the second quarter. In the glyphosate litigation, an appeals court in Missouri upheld an adverse verdict against the company in the Anderson et al. case in May. As a result, Bayer increased its provisions. The company continues to appeal the verdict. “In addition, we’ve recently taken thousands of cases off the table through confidential settlements on a low cost-per-case average in the glyphosate litigation,” Anderson explained. In the glyphosate litigation, in June the Supreme Court of the United States requested a recommendation from the Solicitor General on whether or not to hear the Durnell case. With this decision, the broader timeline of having such a ruling by summer of next year remains intact. However, Bayer’s strategy to tackle the glyphosate litigation is not solely dependent on a positive decision by the Supreme Court. The company also remains active outside of the courtroom and is examining additional options to protect itself, with Anderson noting that “everything remains on the table.” In the litigation surrounding PCBs, Bayer has settled the Burke case on confidential terms. In addition, the company is provisioning for potential settlements with plaintiffs from the Sky Valley Education Center and other litigation costs. The company continues to await a ruling from the Washington State Supreme Court on the Erickson case.

Addressing the additional strategic priorities that Bayer is pursuing, Anderson began by highlighting Pharmaceuticals’ performance. “Beyond the operational success of our Pharma business, we continue to see newsflow on our pipeline and launch assets.” The company is also making headway on its plan to improve profitability in the agricultural business, Anderson said, adding that the Crop Science Division is now in a position to streamline production and operations. The division has also reached a number of important milestones for its crop protection portfolio, with the Environmental Protection Agency (EPA) proposing approval for dicamba in the United States, for instance. In addition, Bayer recently submitted icafolin, a herbicide molecule with blockbuster potential, for approval in the United States, Canada, Brazil and the European Union.

Stable Group sales (Fx & portfolio adj.) and EBITDA before special items

Group sales came in at 10.739 billion euros in the second quarter of 2025, up 0.9 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). There was a negative currency effect of 550 million euros (Q2 2024: 240 million euros). EBITDA before special items amounted to 2.105 billion euros (minus 0.3 percent), and were diminished by a negative currency effect of 184 million euros (Q2 2024: 129 million euros). EBIT came in at 13 million euros (Q2 2024: 525 million euros) after net special charges of 981 million euros (Q2 2024: 490 million euros) that primarily related to allocations to provisions for litigations, impairment loss reversals in the Crop Science Division, and expenses for restructuring. Net income amounted to minus 199 million euros (Q2 2024: minus 34 million euros). Core earnings per share increased by 30.9 percent to 1.23 euros, mainly due to an improved financial result and lower tax expense.

Free cash flow was down 90.2 percent, at 125 million euros. This decline was mainly due to a decrease in operating cash flow that was primarily attributable to higher payments for the Group-wide short-term incentive (STI) program and effects arising from the quarterly shift in the reduction of receivables in the Crop Science Division in the prior year. Net financial debt as of June 30, 2025, stood at 33.274 billion euros, representing a reduction of 2.9 percent against March 31, 2025, that was mainly due to positive currency effects. Compared to June 30, 2024, net financial debt was down 9.5 percent.

Crop Science: Sales up (Fx & portfolio adj.) thanks to corn seed business

In the agricultural business (Crop Science), sales increased by 2.2 percent (Fx & portfolio adj.) to 4.788 billion euros. Corn Seed & Traits sales rose by 29.5 percent (Fx & portfolio adj.) on global price increases and acreage expansion. Business in North America also benefited from volume phasing from the first quarter due to a strategic adjustment of the distribution network. As anticipated, sales at Soybean Seed & Traits and Cotton Seed declined – by 18.1 percent and 25.5 percent (Fx & portfolio adj.), respectively – due to the vacatur of the label for dicamba-based crop protection products in the United States. The overall increase in sales for the seed and traits strategic business entities more than offset an overall decline in sales of crop protection products. The Insecticides business, for instance, was impacted by the expiration of the Movento™ registration in Europe, with sales decreasing 13.1 percent (Fx & portfolio adj.). By contrast, Herbicides sales were up by 1.4 percent (Fx & portfolio adj.), with sales of the glyphosate-based products coming in at the prior-year level as volumes increased, while prices declined.

EBITDA before special items at Crop Science increased by 32.3 percent to 693 million euros, largely thanks to volume phasing from the previous quarter in the corn seed business as well as lower costs. These positive effects more than offset the negative impact from regulatory headwinds. The EBITDA margin before special items rose by 4.0 percentage points to 14.5 percent.

Pharmaceuticals: Nubeqa™ and Kerendia™ continue to post significant gains

Sales of prescription medicines (Pharmaceuticals) came in at 4.470 billion euros, up 0.6 percent (Fx & portfolio adj.). The division again registered particularly strong gains for Nubeqa™, for the treatment of prostate cancer, and Kerendia™, for the treatment of chronic kidney disease associated with type 2 diabetes, with sales rising 50.5 and 67.1 percent (Fx & portfolio adj.), respectively. The Radiology business also delivered substantial growth, primarily driven by higher volumes for Ultravist™ and CT Fluid Delivery. In addition, sales of the ophthalmology drug Eylea™ advanced by 4.3 percent (Fx & portfolio adj.), with business receiving a significant boost from the launch of Eylea™ 8 mg offering extended treatment intervals. These positive effects were partially offset by declines for Xarelto™ in particular, with sales of the oral anticoagulant falling 27.1 percent (Fx & portfolio adj.) due to patent expirations.

EBITDA before special items at Pharmaceuticals decreased by 17.2 percent to 1.094 billion euros. Earnings were impacted by shifts in the product mix, reflecting declines for Xarelto™ and higher sales for Nubeqa™ and Eylea™ in particular, as well as the related increase in license fees. The division also registered a rise in selling and R&D expenses that was partly attributable to the market launch of the heart drug Beyonttra™ (acoramidis) and preparations to support the launch of Lynkuet™ (elinzanetant), a hormone-free treatment for symptoms associated with menopause. Earnings were also diminished by higher investments in early-stage research and in cell and gene therapy and chemoproteomics technologies. Furthermore, the division’s better-than-expected performance resulted in increased expenses for the STI program. By contrast, earnings benefited from cost savings generated by efficiency programs as well as an increase in income from the sale of non-core businesses. The EBITDA margin before special items declined by 4.2 percentage points to 24.5 percent.

Consumer Health: Sales at prior-year level (Fx & portfolio adj.)

Sales of self-care products (Consumer Health) came in at 1.427 billion euros, up 0.2 percent (Fx & portfolio adj.). The division navigated a challenging market environment in the United States and China, characterized by muted consumer sentiment, store closures and market consolidation. Sales were mainly up at Dermatology, with growth of 4.4 percent (Fx & portfolio adj.), and at Allergy & Cold, which posted a gain of 5.7 percent (Fx & portfolio adj.) against a weak prior-year quarter. By contrast, the division recorded a decline of 7.0 percent (Fx & portfolio adj.) at Nutritionals, impacted by market softness in China and cycling over the discontinuation of the direct-to-consumer business under the Care/of brand in the prior year in the United States. In addition, sales at Digestive Health were down 3.8 percent (Fx & portfolio adj.) against a strong prior-year quarter that had benefited from a normalized supply situation.

EBITDA before special items at Consumer Health rose by 5.4 percent to 331 million euros. The growth in earnings was largely due to a decline in the cost of goods sold and a decrease in selling expenses that were driven by efficiencies arising from the division’s continuous cost management efforts. The EBITDA margin before special items increased by 1.7 percentage points to 23.2 percent.

Notes:

The following tables contain the key data for the Bayer Group and its divisions for the second quarter and the first six months of 2025.

The full Half-Year Financial Report is available online at:
www.bayer.com/halfyearreport

The speech given by Bill Anderson and Wolfgang Nickl to the media will be available online from around 10 a.m. CEST at: www.bayer.com/speeches

Live broadcast of the Media Update from around 10 a.m. CEST and recording available from around 3 p.m. CEST at: www.bayer.com/live-mc

Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CEST) and recording (from around 6 p.m. CEST) available at: www.bayer.com/live-ic

Print-quality photos can be found online at: www.bayer.com/photo-footage

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

For the Pharmaceuticals Division, Bayer now expects to post currency- and portfolio-adjusted sales growth of 0 to plus 3 percent (previous forecast: minus 4 to minus 1 percent) and a currency-adjusted EBITDA margin before special items of 24 to 26 percent (previous forecast: 23 to 26 percent). For Crop Science, the company is reaffirming its previous guidance. For the Consumer Health Division, the company now expects currency- and portfolio-adjusted sales growth to come in at the lower end of the projected range of plus 2 to plus 5 percent, while the forecast for the currency-adjusted EBITDA margin before special items remains unchanged at 23 to 24 percent.

Bayer is continuously evaluating the impacts of the current geopolitical developments, especially in relation to tariffs from the US government. The currently projected financial effects are accounted for in the updated full-year guidance.

Bayer expects currency effects to diminish Group sales by around 2 billion euros, EBITDA before special items by approximately 500 million euros, and core earnings per share by about 0.35 euros. Regarding net financial debt, the company expects a positive impact of 1.2 billion euros from currency.

Business performance in the second quarter

Subject to a final audit of its figures, Bayer generated Group sales of approximately 10.7 billion euros in the second quarter of 2025. While the Crop Science Division increased sales by 2.2 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.), the Pharmaceuticals and Consumer Health divisions saw sales come in at prior-year levels, at plus 0.6 percent and plus 0.2 percent (Fx & portfolio adj.), respectively. Group EBITDA before special items came in at around 2.1 billion euros. At divisional level, EBITDA before special items increased to 0.7 billion euros at Crop Science and declined to 1.1 billion euros at Pharmaceuticals. At Consumer Health, EBITDA before special items was slightly above the prior-year level, coming in at 0.3 billion euros. In Reconciliation, EBITDA before special items improved to minus 13 million euros.

Core earnings per share increased to 1.23 euros, mainly driven by a year-on-year improvement in the financial result and lower tax expense. Free cash flow came in at around 0.1 billion euros, while net financial debt amounted to 33.3 billion euros.

Special items in EBIT totaled approximately minus 1 billion euros, and mainly related to approximately 0.8 billion euros in impairment loss reversals from impairment testing at Crop Science as well as approximately 1.7 billion euros in provisions and liabilities for litigation in the United States.

For the full-year, Bayer now expects special items in EBITDA to amount to minus 3.5 to minus 2.5 billion euros (previous forecast: minus 1.5 to minus 0.5 billion euros).

Litigation in the United States

Bayer has established additional provisions of around 1.2 billion euros for the Roundup™ (glyphosate) litigation. This figure is included in the around 1.7 billion euro total mentioned above. In addition to covering defense costs, these additional provisions were mainly attributable to an adverse verdict on the company’s appeal in the Anderson et al. case. The company has taken further legal action against the ruling and filed an application for the case to be transferred to the Missouri Supreme Court for review.

Furthermore, the company has achieved a major settlement with a plaintiffs’ law firm, reducing the total number of unresolved glyphosate claims to 61,000. Of the 192,000 claims in total, 131,000 have been settled or are not eligible.

Settlements are part of the company’s multi-pronged strategy to significantly contain the US litigation by the end of 2026.

For PCBs, Bayer recorded 530 million euros in additional provisions and liabilities for the Burke case, potential future settlements related to the Sky Valley Education Center (SVEC) in the US state of Washington, and other litigation costs. This figure is likewise included in the around 1.7 billion euro total mentioned above. Most of the claims alleging personal injury due to PCB exposure relate to the SVEC, a school building in the Seattle area. With respect to the past SVEC verdicts, Bayer continues to await a ruling from the Washington Supreme Court on the Erickson case.

Bayer will publish detailed results for the second quarter on August 6, 2025. Definitions of the key performance indicators applied can be found on pages 76 to 78 of the 2024 Annual Report.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide.  References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Icafolin belongs to a new chemical class providing unique properties that allow for lower dose rates, more targeted applications, and is expected to demonstrate an exceptional safety and sustainability profile. In addition, Icafolin is complementary to existing herbicides, such as glyphosate, adding a novel solution in the fight against weed resistance, a top priority for farmers. Weed resistances have increased globally over the last years and are a threat to food security as resistant weeds are competing with crops on sunlight and nutrients, thus significantly reducing yield and harvest quality.

“Weeds threaten food security and farmer livelihoods, which is why investing in game-changing innovations like Icafolin is so vitally important,” said Mike Graham, Head of Research & Development for the Crop Science division of Bayer. “Access to an entirely new herbicide class that complements the existing toolbox not only helps farmers combat and prevent weed resistance, but it also helps farmers adopt and maintain no-till and reduced tillage practices that improve soil health, which is a cornerstone of regenerative agriculture.”

Icafolin has been developed for initial uses in soybean, cereals, pulses, and oil seed crops, as well as pome and stone fruits, tree nuts, grapes, and citrus. As a novel mode of action, it has unique properties and benefits. Treated weeds become “frozen” in the fields, meaning they stop competing with crops for water, nutrients and sunlight, but the dead weeds remain in the field longer because they largely maintain their structure. This creates a mulch layer that helps prevent erosion and trap moisture in the soil. By providing effective weed control it reduces the need for tillage, supporting regenerative practices in agriculture that can improve soil health.

Additionally, Icafolin's intrinsic properties make it suitable for targeted spray applications and lower dose rates, which allowed Bayer to submit registration applications under reduced risk status. Icafolin is the first product to utilize CropKey, Bayer’s breakthrough R&D approach to developing new crop protection products, which optimized the formulation recipe by considering multiple dimensions including efficacy, safety and sustainability criteria, and farmer convenience. CropKey will continue to accelerate how researchers design instead of screen for new molecules, supporting faster development of future products targeting specific proteins in weeds, pests, and crop diseases.

“With CropKey we're not just responding to current agricultural challenges more quickly, we're being proactive and anticipating future needs,” said Rachel Rama, Senior Vice President and Head of Small Molecules at Bayer's Crop Science division. “Leveraging artificial intelligence greatly accelerates our journey from concept to market, so farmers gain access to the most effective and environmentally responsible crop protection products.”

Following the first expected launch from 2028 onward in Brazil, Bayer anticipates selling Icafolin in the U.S, Canada, EU and other geographies over subsequent years.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries:
Benjamin Eberle, phone +1 314 2586187
Email: benjamin.eberle@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Darolutamide, under the brand name Nubeqa™, is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease.

“Today’s approval of darolutamide plus ADT means that it can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients and improve clinical outcomes for men with mHSPC,” said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial. “Results from the ARANOTE trial demonstrate that darolutamide plus ADT delays disease progression and extends survival, and just as importantly, due to its high tolerability, enables patients to maintain their daily living with minimal disruption.”

Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.

“The third European approval of darolutamide represents a significant step forward for men with advanced prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Darolutamide is the first androgen receptor inhibitor to show clinically meaningful health-related quality of life benefits, offering patients an effective and well tolerated treatment. Backed by compelling clinical data from the ARANOTE, ARASENS, and ARAMIS trials, we believe darolutamide has the potential to become a leading therapy across various stages of prostate cancer. We are committed to ensuring its broad availability to benefit as many eligible patients as possible.”

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARANOTE Trial
The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint is radiological progression free survival (rPFS), measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in rPFS were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of all adverse events (AE), including the incidence of serious and grade 3 and grade 4 AE, in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide's low potential for blood-brain barrier penetration.

Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were similar to the respective comparator arm. With this tolerability profile and limited risk of interactions with other medications, Nubeqa offers an advancement in treatment management for physicians and patients.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy.

About Metastatic Hormone-Sensitive Prostate Cancer
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed. For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an ARi.

Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer has initiated numerous measures to address its five strategic priorities: strengthening the Pharmaceuticals pipeline, improving profitability at Crop Science, becoming leaner and more innovative through the new operating model, deleveraging and containing the legal risks in the United States. These measures are now starting to deliver tangible impact. For example, Bayer has successfully advanced the Pharmaceuticals pipeline. Building on the division’s strong foundations, the new product launches have displayed highly encouraging growth momentum. Regarding profitability in the Crop Science business, the company is already executing initial measures as part of a comprehensive five-year framework. Bayer is also making headway in implementing Dynamic Shared Ownership. This new operating model is designed to radically eliminate bureaucracy and significantly speed up decision-making by placing it mainly in the hands of those closest to customers and products. Since rolling out the new operating model, the company has significantly reduced the number of hierarchy layers in the organization, with the number of management positions having been roughly halved. There are now around 11,000 fewer positions overall at Bayer. Through these measures, the company is progressing in delivering the two billion euros in planned savings for 2026. Bayer has also been able to reduce debt. Finally, the company is executing a multi-pronged strategy as part of its efforts to significantly contain the legal risks in the United States.

Anderson believes the company is making good progress. Bayer has numerous opportunities to capitalize on, as well as some serious challenges that it is diligently addressing, he said. “With our mission of ‘Health for all, Hunger for none’, we serve the needs of people all around the world. That’s what motivates my colleagues – and it’s also something that inspires me each and every day. I truly believe that our team has the right focus and the right plan to become the leanest, fastest, and most innovative life science company. Team Bayer is all in and we are totally up to the task. I’m delighted to be a part of Team Bayer and I’d like to thank the members of the Supervisory Board – the stockholder and employee representatives alike – for the trust they have placed in me,” Anderson said.

Born in 1966, William N. (Bill) Anderson is an American chemical engineer and executive. He started his professional career in 1989. Following roles at Ethyl Corporation and Raychem Corporation, he joined Biogen, an American biotechnology firm, in 1997. After serving in various leadership roles, Anderson was appointed General Manager of Biogen’s Neurology Unit, the company’s largest business unit. In 2006, he joined Genentech, a pioneering American biotechnology company, eventually serving as Senior Vice President in the firm’s BioOncology Unit.

Anderson left this role in 2013 to join Roche Pharmaceuticals, the parent company of Genentech, as Head of Global Product Strategy and Chief Marketing Officer. After serving in this position until 2016, he moved back to Genentech to assume the position of Head of North American Operations before becoming CEO of the company in 2017. In 2019, Anderson became CEO of Roche Pharmaceuticals. Bill Anderson is married and the father of three adult children.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Note:
Print-quality photos can be downloaded from our website at 
https://www.bayer.com/en/media/visual-assets-board-of-management

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

1.     Lynkuet 60 mg soft capsules. UK SmPC.

2.     Avis NE, et al. Vasomotor symptoms across the menopause transition: differences among women. Obstetrics and gynecology clinics of North America. 2018 Oct 25;45(4):629.

3.     S. Kinsberg, et al. Real-world evaluation of treatment utilization by women experiencing vasomotor symptoms associated with menopause in the United States and Europe: Findings from the REALISE study. Maturitas 189 (2024) 108096. https://doi.org/10.1016/j.maturitas.2024.108096

4.     Pinkerton JV, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024 Oct 22;332(16):1343-54.

5.     Angelo SD, et al. Impact of Menopausal Symptoms on Work: Findings from Women in the Health and Employment after Fifty (HEAF) Study. Int. J. Environ. Res. Public Health 2023, 20, 295. https://doi.org/10.3390/ijerph20010295.

6.     Kenneth Hill. The demography of menopause. Maturitas 23 (1996) 113-127. Journal of the Climacteric & Postmenopause. SSDI 0327-5122(95)00968-R.

7.     Menopause. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/menopause. Last accessed: June 2025.

8.     Wulf H Utian. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes 2005, 3:47 doi:10.1186/1477-7525-3-47

*       In the UK, this medicine is subject to additional monitoring. This will allow quick identification of new safety information. Side effects will be reported directly via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk/. By reporting side effects, more information on the safety of this medicine can be provided.

“We see this request as an encouraging step and look forward to hearing the views of the government on FIFRA’s federal preemption provision, which relies on language common to several federal laws that cover a number of industries,” said Bayer CEO Bill Anderson. “The security and affordability of the food supply depend on companies’ and farmers’ ability to rely on decisions made by responsible federal regulatory authorities. When courts permit companies to be punished under state law for following federal law, it makes companies like ours a prime target of the litigation industry and threatens farmers and innovations that patients and consumers need for their nutrition and health.”

In its petition, the company argues that a split among federal circuit courts in the Roundup™ litigation warrants review and resolution by the country’s top court. The 3rd Circuit Court of Appeals unanimously held in the Schaffner case that the Federal Insecticide Fungicide and Rodenticide Act (FIRFA) expressly preempted the plaintiff’s state claims based on failure-to-warn theories. The 9th and 11th Circuits and Missouri’s intermediate appellate court in Durnell have reached different conclusions on the preemption question and the petition argues that both state and federal courts require guidance that only the U.S. Supreme Court can provide. Durnell is the first case for which Monsanto has sought Supreme Court review since the Schaffner decision created a split among the federal circuit courts.

Once the Solicitor General provides its views, the Supreme Court will then make a decision on the company’s petition during the 2025-2026 Court session. If the Court accepts the case, a decision on the merits could still happen during the Court’s next session which ends in June 2026. A positive ruling on the central, cross-cutting issue in the Roundup™ litigation – whether federal law preempts claims based on state failure-to-warn theories – could help to largely contain this litigation.

In the past weeks, 18 organizations and coalitions, representing agriculture, legal thought leaders, U.S. manufacturers, scientific communities, and a broad swath of business leaders from across the nation, filed amicus briefs urging the Supreme Court to grant Monsanto's petition. The Chamber of Commerce wrote: “The stakes of this case, and others like it, are enormous … [I]f federal preemption is discarded in cases like this one, manufacturers will routinely face potentially crushing liability under state law for failing to give warnings that federal law forbids.” 

Several grower groups like the American Farm Bureau Federation wrote in their amici briefs: “Put simply, America’s agricultural industry could not operate without glyphosate ... Immediate devastation will occur for agricultural operations and American food supply.”

“The litigation industry is spending hundreds of millions of dollars targeting Monsanto for not providing warnings they allege are required under state law, even though the U.S. Environmental Protection Agency (EPA) and every other health regulator worldwide that has assessed the safety of glyphosate has found that it is safe to use and does not cause cancer,” Anderson said.

Bayer remains committed to significantly containing the U.S. litigation by the end of 2026. To achieve this goal, the company will continue its multipronged strategy. The company supports regulatory measures that would reinforce the preemptive effect of the EPA’s human health assessments and approved labeling for products registered under FIFRA). FIFRA already prohibits states from imposing ‘any requirements for labeling or packaging in addition to or different from’ those required under federal law. The company supports a petition filed by 11 state Attorneys General calling on the agency to strengthen its regulations and specify that state labeling requirements, which are different than those determined by the EPA, would render the product misbranded. This petition, which received broad industry support, is now under consideration by the EPA.

Building off the efforts of elected officials and farmers in Georgia and North Dakota, the company will continue to work with state and federal legislators, along with more than 360 grower and industry groups, to reinforce that compliance with federal labels is sufficient to meet state warning requirements, consistent with the uniformity provision of FIFRA.

The company has obtained favorable outcomes in 17 of the last 25 trials and will continue to try cases based on the overwhelming scientific support for glyphosate’s safety. It will also consider resolving claims by settlements if the terms are in Monsanto’s strategic interest.

Additional options under consideration include state and federal executive branch actions consistent with current FIFRA policy on preemption, and limiting or ending the sale of glyphosate-based products. Lastly, the company continues to assess other options that would help protect the company and its other products from the financial threats posed by the litigation industry and its ceaseless attacks on glyphosate-based products.

In October 2023, Durnell was tried in Missouri Circuit Court for the City of St. Louis and the jury returned a verdict in favor of the plaintiff. The jury found the company failed to warn of the product’s risk and awarded 1.25 million U.S. dollar to the plaintiff, but it rejected all other claims and declined to award punitive damages. The company appealed the verdict in August 2024 and the Missouri Court of Appeals, Eastern District upheld the verdict in February 2025. Monsanto promptly filed a writ to transfer the case to the Missouri Supreme Court, and it declined review on April 1, making it ripe for U.S. Supreme Court review.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide.  References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” stated Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This translates to decreased burden of disease for patients and may enhance adherence to treatment. For ophthalmologists, it allows for greater capacity to treat additional patients. Given its distinctive product profile, Eylea 8 mg has the potential to establish a new standard of care for retinal diseases.”

The EC decision is based on additional positive results from the third year open-label extension phase of the pivotal clinical trials PULSAR in nAMD and PHOTON in DME. In both extension phases (study weeks 96-156), patients originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of three years.

The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including for patients switching from Eylea 2 mg to Eylea 8 mg at week 96. The rates for ocular treatment emergent adverse events were similar across all treatment groups.

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 89 million applications and more than 13 million patient-years of experience worldwide.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.

About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.

Diabetic macular edema (DME) is a common complication in the eyes of people living with diabetes. DME occurs when high levels of blood sugar leads to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME affects around 27 million people globally.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

With this approval, Nubeqa plus ADT is indicated in the U.S. for the treatment of adult patients with mHSPC, either with or without docetaxel. In addition, Nubeqa is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

“Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with androgen-deprivation therapy,” said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial. “Combined with the strong clinical efficacy demonstrated in the ARASENS trial (Nubeqa plus ADT and docetaxel), today’s approval further expands options for how physicians can use Nubeqa in the treatment of mHSPC, giving them greater flexibility in choosing treatment plans for their patients.”

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.

“Patients with mHSPC want treatments that delay disease progression and extend life - without compromising their ability to stay active,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This approval, supported by compelling clinical data, reaffirms Nubeqa’s potential to become a leading therapy across various stages of prostate cancer, underscoring our commitment to deliver meaningful outcomes for patients and their loved ones.”

Darolutamide under the brand name Nubeqa™ is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets around the world. It’s also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world. An approval process in the EU for the treatment of mHSPC in combination with ADT (without Docetaxel) is already underway.

Nubeqa achieved blockbuster status in September 2024, with annual sales reaching €1.52 billion for the full year of 2024.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARANOTE Trial
The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti- cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of all adverse events (AE), including the incidence of serious and grade 3 and grade 4 AE, in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration.

Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile in both registrational studies in mHSPC where the incidences of adverse events were similar to the respective comparator arm. With this tolerability profile and limited risk of interactions with other medications, Nubeqa offers an advancement in treatment management for physicians and patients.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.

About Metastatic Hormone-Sensitive Prostate Cancer
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed. For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi).

Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon, Portugal. “With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options.”

In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline at week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data ^{1, 2, 3} on elinzanetant in postmenopausal women with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.

The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001). Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo.

“The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may impact their ability to adhere to other treatments,” said Dr. Christian Rommel, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Global Head of Research and Development. “Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women.”

Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis.⁴

Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence⁵. Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy.

Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the Journal of the American Medical Association (JAMA)³ in August 2024. Detailed results of the Phase III study OASIS-3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for treatment or prevention of hormone receptor positive (HR+) breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.

About Elinzanetant
Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK- 3 receptors, globally in late-stage clinical development for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

¹ Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.

² Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.

³ Pinkerton JV, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024 Oct 22;332(16):1343-54.

⁴ Davies C, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. The Lancet. 2013 Mar 9;381(9869):805-16.

⁵ Smith, K.L., Verma, N., Blackford, A.L. et al. Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation. npj Breast Cancer 8, 53 (2022). https://doi.org/10.1038/s41523-022-00414-0

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“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, sevabertinib will help address critical unmet needs and improve outcomes for these patients, who currently have a poor prognosis and limited treatment options.”

The regulatory application for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced NSCLC harboring a HER2-activating mutation, with disease progression after ≥1 systemic therapies for advanced disease, and who were naïve to treatment with a HER2-targeted TKI.

The Breakthrough Therapy designation for sevabertinib was supported by preliminary clinical evidence from the SOHO-01 trial. A Breakthrough Therapy designation is specifically designed to expedite the development and review of investigational medicines that have the potential to provide substantial improvement over available therapies in areas of high unmet medical need. By expediting the development and review process via a Breakthrough Therapy designation, promising therapies can be made available to patients as quickly and as safely as possible.

Results from SOHO-01 (NCT05099172)^[2]

SOHO-01 is an ongoing, open-label, multicenter Phase I/II study. The latest results are from two expansion cohorts; patients with advanced NSCLC with HER2-activating mutations who had disease progression after ≥1 systemic therapies and were either naïve to HER2-targeted therapy (Cohort D) or previously treated with HER2-targeted antibody-drug conjugates (Cohort E). Both cohorts received oral sevabertinib 20 mg twice daily.

As of October 14, 2024, 44 patients from cohort D and 34 patients from cohort E were treated. The investigator-assessed objective response rate was 70.5% (95% CI 54.8, 83.2) in D and 35.3% (95% CI 19.7, 53.5) in E. The disease control rates (response or stable disease for ≥12 weeks) were 81.8% (D) and 52.9% (E). Median duration of response (DOR) was 8.7 months (95% CI 4.5, not estimable [NE]) in D and 9.5 months (95% CI 4.1, NE) in E.

The safety profile of sevabertinib was found to be manageable, and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 97.4% of patients; diarrhea was the most common TRAE leading to dose reduction, but no patients discontinued treatment due to diarrhea. There were no cases of interstitial lung disease.

About sevabertinib (BAY 2927088)
Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations. The ongoing Phase III SOHO-02 trial (NCT 06452277) is evaluating BAY 2927088 as a first-line treatment option for these patients. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations (panSOHO), excluding advanced non-small cell lung cancer (NSCLC). Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

^[1] U.S. Food and Drug Administration. “Priority Review.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed April 23, 2025. 

^[2] N. Girard, H.H.F. Loong, B-C. Goh et al. 30: Phase I/II SOHO-01 study of BAY 2927088 in patients with previously treated HER2-mutant NSCLC: Safety and efficacy results from 2 expansion cohorts, Journal of Thoracic Oncology,Volume 20, Issue 3, Supplement 1,2025,Pages S5-S6,ISSN 1556-0864. Available at: https://www.sciencedirect.com/science/article/pii/S1556086425001984

“Following approval of the European Commission, extended treatment intervals with Eylea 8 mg of up to 6 months can significantly reduce the frequency of injections and visits to the clinic for patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “These extended intervals, combined with the unique product profile of Eylea 8 mg, position it to become a new standard of care for retinal diseases.”

The CHMP opinion is based on positive three-year results from open-label extension studies of the pivotal clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg at baseline maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of three years.

The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including for patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar across all treatment groups.

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing. Eylea 8 mg is the only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 5 months (after 3 initial monthly injections) for both nAMD and DME, in the EU and UK.

Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 88 million applications and more than 12 million patient-years of experience worldwide.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.

About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.

Diabetic macular edema (DME) is a common complication in the eyes of people living with diabetes. DME occurs when high levels of blood sugar leads to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME affects around 27 million people globally.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Five-year plan for Crop Science to strengthen the company

Bayer has a plan in place to advance its strategic priorities, said Anderson, who had provided a detailed update on the progress being made at the Annual Stockholders’ Meeting in late April. Profitability at Crop Science was added as a focus area at the start of the year. On Tuesday, Bayer confirmed the mid-term ambition for Crop Science. The division is expected to achieve above-market growth and deliver more than 3.5 billion euros of incremental sales from innovation by 2029. By the same year, the division is targeting an EBITDA margin before special items in the mid-20s percentage range. Cash productivity is also set to increase, with Crop Science targeting a free operating cash flow of over 3 billion euros in 2029.

The division has a comprehensive strategy in place to achieve these goals, and has already begun executing it. As previously communicated, the company has launched a five-year plan to combat industry-wide cost pressures, especially in the crop protection business. The measures include streamlining the product portfolio, focusing research and development (R&D) on value-generating innovations, and optimizing the production network. In doing so, the Crop Science Division aims to not only improve its position in the mid-term but also increase resilience and adaptability across the entire organization to manage macroeconomic and geopolitical uncertainties.

With the global population reaching 10 billion in 2050, the future for agriculture lies in innovative solutions that enable farmers to produce more while reducing the environmental impact and restoring soil health. As the innovation leader of the industry, the Crop Science Division is committed to delivering new blockbuster products and providing tools that enable regenerative agricultural systems. Examples include the Preceon™ Smart Corn System, Vyconic™ soybeans, an industry-first trait package with tolerance to five herbicides, as well as the new herbicide icafolin.

“We are radically focusing on improving profitability, delivering top-notch innovation and leveraging new value pools. We are taking decisive action on our challenges, and we are focusing the business to deliver innovations faster than ever before,” said Rodrigo Santos, member of the Board of Management of Bayer AG and head of the Crop Science Division, at a webinar for investors.

Group sales level year on year

Group sales came in at 13.738 billion euros in the first quarter of 2025. After adjusting for currency and portfolio effects (Fx & portfolio adj.), sales were level with the prior-year quarter (minus 0.1 percent). There was a negative currency effect of 55 million euros (Q1 2024: 525 million euros). EBITDA before special items decreased by 7.4 percent to 4.085 billion euros. Earnings were held back by the business performance in the Crop Science Division, higher expenses for the Group-wide long-term incentive (LTI) program and a negative currency effect of 165 million euros (Q1 2024: 206 million euros) arising primarily from hyperinflationary impacts. EBIT declined by 24.8 percent to 2.324 billion euros after net special charges of 587 million euros (Q1 2024: 207 million euros). The special charges primarily related to allocations to provisions for the Roundup™ litigations as well as to expenses for ongoing restructuring measures. Net income decreased by 35.1 percent to 1.299 billion euros, while core earnings per share fell by 11.7 percent to 2.49 euros, mainly due to the decline in EBITDA before special items in the Crop Science Division.

Free cash flow improved to minus 1.528 billion euros (Q1 2024: minus 2.626 billion euros), mainly thanks to advance payments from Crop Science customers partially offsetting negative seasonal impacts relating to the cyclical nature of the division’s business. Net financial debt as of March 31, 2025, amounted to 34.255 billion euros, marking a 5.0 percent increase from year-end 2024 that was mainly due to seasonal cash outflows from operating activities in the first quarter. However, compared to March 31, 2024, net financial debt was down 8.6 percent.

Crop Science posts moderate decline in sales as expected

Sales in the agricultural business decreased as expected, falling 3.3 percent (Fx & portfolio adj.) to 7.580 billion euros. Business was mainly down due to the vacatur of the label for the company’s dicamba-based crop protection products in the United States, which weighed on seeds and traits, as well as to the expiration of the Movento™ registration in Europe, which resulted in sales declines at Insecticides. As previously communicated, seeds and traits were additionally impacted by planned volume phasing into the second quarter in North America following a strategic change of distribution network. In the Herbicides business, sales of glyphosate-based products fell substantially, largely due to volume phasing into subsequent quarters in Latin America and North America, whereas non-glyphosate-based products saw higher volumes against a soft prior-year quarter. Sales at Fungicides were roughly level with the prior-year quarter, with volume recovery slightly outweighing a decline in prices.

EBITDA before special items at Crop Science decreased by 10.2 percent to 2.557 billion euros, with earnings mainly held back by the decline in sales due to regulatory impacts. The EBITDA margin before special items declined by 2.3 percentage points to 33.7 percent.

Pharmaceuticals: Sales gains drive earnings growth

Sales of prescription medicines (Pharmaceuticals) increased by 4.1 percent (Fx & portfolio adj.) to 4.548 billion euros. The division’s new products achieved significant gains, with growth rates of 77.5 percent (Fx & portfolio adj.) for the cancer drug Nubeqa™ and 86.6 percent (Fx & portfolio adj.) for Kerendia™, for the treatment of chronic kidney disease associated with type 2 diabetes. Pharmaceuticals also posted continued sales growth for the ophthalmology drug Eylea™, with an increase of 4.7 percent (Fx & portfolio adj.), as well as in the Radiology business, largely driven by higher volumes for CT Fluid Delivery and Ultravist™. The Mirena™ and YAZ™ families of contraceptive products likewise saw strong growth, registering gains of 18.4 percent and 14.1 percent (Fx & portfolio adj.), respectively. These positive effects were partially offset by declines for Xarelto™ in particular. Sales of the oral anticoagulant fell 31.2 percent (Fx & portfolio adj.) due to competitive pressure from generics, especially in Europe and Japan.

EBITDA before special items at Pharmaceuticals increased by 12.4 percent to 1.342 billion euros, mainly thanks to the increase in sales. Earnings also benefited from cost savings generated by efficiency programs and one-time effects. The EBITDA margin before special items rose by 2.1 percentage points to 29.5 percent.

Consumer Health: Sales up thanks to volume growth in North America and Asia/Pacific

Sales of self-care products (Consumer Health) increased by 2.5 percent (Fx & portfolio adj.) to 1.499 billion euros, with business up in three out of four regions. Growth was largely fueled by higher volumes in North America and Asia/Pacific. Additional drivers included a 12.7 percent increase in sales (Fx & portfolio adj.) at Digestive Health, with contributions from all regions, as well as higher sales of cough and cold products in the United States following a slow start to the season in the previous quarter. By contrast, sales were down in the allergy business and the Nutritionals category, with the latter recording a decline of 5.2 percent (Fx & portfolio adj.).

EBITDA before special items at Consumer Health rose by 3.3 percent to 342 million euros, largely due to the increase in sales. In addition, the division’s continuous cost management efforts had a positive impact, including a reduction in the cost of goods sold. By contrast, earnings were held back by higher investments in marketing innovative products. In addition, the prior-year quarter benefited from income from the sale of minor, non-strategic brands. The EBITDA margin before special items declined by 0.3 percentage points to 22.8 percent.

Currency-adjusted Group guidance for 2025 confirmed

Bayer has confirmed its currency-adjusted Group outlook for 2025. The company now expects sales growth (Fx & portfolio adj.) and the EBITDA margin before special items at the Pharmaceuticals Division to come in at the upper end of the range given in the Annual Report 2024. In view of developments with respect to the legal risks, Bayer expects the special items in both EBIT and EBITDA to come in at the upper end of the range given in the guidance (approximately minus 1.5 billion euros). The company is continuously evaluating the impacts of the current geopolitical developments, especially in relation to potential tariffs. Based on current calculations of the financial effects, Bayer does not see a need to revise the full-year guidance. However, there is considerable uncertainty concerning the future impacts of any potential further developments in relation to this issue, as well as with respect to exchange-rate developments.

Notes:

The following tables contain the key data for the Bayer Group and its divisions for the first quarter of 2025.

The full Quarterly Statement for the first quarter is available online at: www.bayer.com/quarterly-statement

The speech given by Bill Anderson and Wolfgang Nickl to the media will be available online from around 9 a.m. CEST at: www.bayer.com/speeches

Live broadcast of the media update from around 9 a.m. CEST and recording available from around 2 p.m. CEST at: www.bayer.com/live-mc

Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CEST) and recording (from around 6 p.m. CEST) available at: www.bayer.com/live-ic

Access to the live broadcast of the Crop Science Investor Webinar (from around 4 p.m. CEST) and recording (as soon as possible after the event) available at: www.bayer.com/cs-webinar

Print-quality photos can be found online at: www.bayer.com/photo-footage

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments..

Commenting on Bayer’s strategic priorities, Anderson highlighted the rapid progress the company has made in its Pharmaceuticals pipeline. “In less than two years, our team has advanced or completed more than 25 clinical trials. Since November of 2023, we’ve announced nine positive Phase III readouts.” This year, the company is launching two new molecules and two new indications. These new launches will help mitigate headwinds from the expiration of patents on the oral anticoagulant Xarelto™, which is expected to impact 2025 sales by between 1 and 1.5 billion euros. The Pharmaceuticals Division plans to return to growth as of 2027. Looking ahead, Anderson has high hopes for cell and gene therapies in the treatment of Parkinson’s disease, for example. “No other company in the world can claim as much progress in this area as we can,” he said, while acknowledging that “we’re still years away from a potential market launch.”

Bayer is committed to significantly containing litigation by the end of 2026. The company continues to defend itself vigorously in court and is appealing all adverse verdicts. Three weeks ago, Bayer filed a petition with the US Supreme Court to review the critical issue of whether or not US federal law preempts failure-to-warn claims relating to glyphosate-based products. The company is pursuing a multi-pronged strategy and is making the case with lawmakers that US farmers deserve regulatory clarity, with initial successes achieved in the US states of Georgia and North Dakota. “The status quo is not an option. And the stakes are really high, for us and for US farmers,” Anderson said, adding: “In fact, we’re nearing a point where the litigation industry could force us to even stop selling this vital product. That’s not something we want to do, but we need to be prepared for all outcomes.”

“Authorized capital is in shareholder interests”

Anderson also talked about Bayer’s cash and deleveraging efforts, with the company having reduced its net financial debt to 32.6 billion euros last year. However, this figure is still too high, he said, noting that Bayer’s focus on further reducing its debt is closely connected to its efforts to contain the litigation threat. In order to gain important flexibility in containing litigation while maintaining a credit rating at an appropriate level, the company is seeking shareholder approval at the Annual Stockholders’ Meeting for a potential capital increase of up to 35 percent, with subscription rights available to all stockholders. “We feel strongly that authorized capital is in shareholder interests,” Anderson said. The company currently has no specific plans to make use of the authorized capital, he noted. “If we were to make use of it, we would only do so in connection with measures to substantially contain litigation in the US – and only after first considering other financing options.” The dividend proposal for 2024 also supports the company’s efforts to reduce its debt. As communicated last year, Bayer is proposing paying out only the statutory minimum, resulting in an unchanged dividend of 0.11 euros per share.

Anderson also pointed to the major strides Bayer has made in fighting bureaucracy. In less than two years, Bayer has reduced the number of hierarchy layers from as many as 12 down to six or seven throughout most of the organization, and there are some 10,000 positions fewer overall. In addition, the number of management positions has been roughly halved, while the number of people assigned to a single manager has more than doubled. “As a Group, in 2025 we’re planning on expanding decision-making power to more Bayer people and generating 800 million euros of savings toward our 2026 goal of 2 billion euros in organizational savings,” the Bayer CEO said.

Anderson also addressed the topic of Crop Science profitability, which has been added as a fifth strategic priority. He reiterated Bayer’s mid-term ambition for the Crop Science business: The company is targeting above-market growth, including more than 3.5 billion euros of incremental sales from innovation and an EBITDA margin improvement before special items to the mid-20s by 2029. The Crop Science team has a far-reaching five-year plan, which includes focusing the portfolio and getting the most out of the pipeline, he said, noting that more information will be shared on May 13.

In fiscal 2024, Bayer achieved its adjusted full-year guidance. Sales came in at 46.6 billion euros, representing an increase of approximately 1 percent on a currency- and portfolio-adjusted basis. Core earnings per share amounted to 5.05 euros (minus 21 percent), while free cash flow came in at 3.1 billion, exceeding the company’s guidance. Bayer expects 2025 to be the most difficult year of its turnaround. On a Group level, it anticipates net sales roughly in line with and earnings and free cash flow behind the prior year. It sees an improved trajectory for the company from 2026 onwards.

Notes:

Further information is available online at www.bayer.com/stockholders-meeting:

- Livestream of the entire Annual Stockholders’ Meeting (from approx. 10 a.m. CEST)
- Recording of the speeches by Prof. Dr. Norbert Winkeljohann and Bill Anderson (as soon as possible after the event)
- Voting results (as soon as possible after the event)
- Agenda and further information on the event

Further information is available at www.bayer.com/news

- Addresses by Prof. Dr. Norbert Winkeljohann and Bill Anderson
- Recent Bayer photo material and images from the Annual Stockholders’ Meeting (as soon as they are available)

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The security and affordability of the food supply depend on having innovative agricultural tools like Roundup™ available to farmers with uniform and science-based labels that everyone in the stream of commerce can rely on, as dictated by federal law. Yet the litigation industry is spending hundreds of millions of dollars, based on a single outlier report that is now a decade old, in an effort to punish the company for marketing a product without a cancer warning, even though the EPA and every other health regulator worldwide that has assessed the safety of glyphosate, the active ingredient in Roundup™, has found that it does not cause cancer. A favorable ruling by the Supreme Court could largely curtail this litigation.

The company argues that the Third Circuit Court of Appeals was correct when it unanimously held in Schaffner that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempted the plaintiff’s failure-to-warn claim, because a jury verdict in his favor would impose labeling requirements different from what EPA requires in administering FIFRA. FIFRA’s express preemption clause declares that a state ‘shall not impose or continue in effect any requirements for labeling…in addition to or different from those required’ under federal law.

In Durnell, the jury’s verdict rests solely on the claim that Missouri law requires the company to warn that Roundup™ is carcinogenic, the precise warning that EPA rejects. This claim is plainly in conflict with the product label EPA approved under federal law, based on the agency’s rigorous scientific assessment, and cannot be changed without agency approval. Thus, it is expressly preempted.

The 9th and 11th Circuits and Missouri’s intermediate appellate court have reached different conclusions on the preemption question and the petition argues that state and federal courts require guidance that only the U.S. Supreme Court can provide. The petition states that courts in Hardeman, Carson and Durnell erred because they ignored EPA regulations that require agency approval in advance of any label change, especially precautionary statements regarding human health. Thus, a state-based requirement to provide a cancer warning not currently on the EPA approved label is ‘in addition to or different from’ federal requirements and thus expressly preempted by FIFRA’s labeling requirements. Moreover, these contrary holdings would open the door to 50 different state-required labels for glyphosate-containing herbicides, and any other products governed by FIFRA, in conflict with the clear intent and letter of the Uniformity provision of this federal law.

The petition also notes that there is preemption language similar to FIFRA in statutes regulating medical devices, poultry products, meat and motor vehicles that make resolution of this preemption split even more important, as courts often are guided by prior decisions interpreting similar language in other statutes.

Monsanto’s petition argues that Durnell’s state-based failure-to-warn claim also should be dismissed under implied preemption because it is impossible for the company to comply with both federal and state requirements for the same reasons already noted.

Monsanto filed two prior petitions in the Roundup™ litigation on the federal preemption question with the U.S. Supreme Court, in Hardeman and Pilliod, the second and third cases to go to trial. Significantly, both petitions were filed before the U.S. Court of Appeals for the Third Circuit ruled in the company’s favor in Schaffner in August 2024, creating a circuit split.

In October 2023, Durnell was tried in Missouri Circuit Court for the City of St. Louis and the jury returned a verdict in favor of the plaintiff. The jury found the Company failed to warn of the product’s risk and awarded 1.25 million US-Dollars to the plaintiff, but it rejected all other claims and declined to award punitive damages. The company appealed the verdict in August 2024 and the Missouri Court of Appeals, Eastern District upheld the verdict in February 2025. Monsanto promptly filed a writ to transfer the case to the Missouri Supreme Court and it declined review on April 1, making it ripe for U.S. Supreme Court review and the petition filed just three days later.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries:
Philipp Blank, phone +49 214 30-20499
Email: philipp.blank@bayer.com

Brian Leake, phone +1-314-370-3285
Email: brian.leake@bayer.com

Contact for U.S. investor inquiries:
Erica Mulligan, phone +49 214 30-72704
Email: erica.mulligan@bayer.com

Contact for global investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

“Millions of people around the world, particularly in Sub-Saharan Africa, suffer from severe food insecurity. Ending hunger is central to our mission at Bayer. With our new seed facility in Zambia, we want to make a meaningful contribution to that crucial goal,” said Chief Executive Officer Bill Anderson, who inaugurated the site alongside his excellency Hakainde Hichilema, President of Zambia.

Facility to Benefit Smallholder Farmers Who Are Essential to Food Security

Despite its vast arable land and significant agricultural potential, particularly in Sub-Saharan Africa, one in five people on the continent face food and nutrition insecurity. Key reasons for this include limited agronomic knowledge and access to modern technology. With its new site, Bayer is helping to address these challenges by increasing both the quantity and especially the quality of available certified seeds, offering higher yields and enhanced resilience to climate and disease. Alongside stewardship and agronomic training, these conventional hybrid maize seeds empower farmers in Zambia and neighboring countries to produce more food more efficiently, thereby increasing their productivity and contributing to food security.

This particularly accounts for smallholder farmers, who on average cultivate crops on less than 10 hectares and produce up to 70 percent of the food consumed on the continent. “Enhanced productivity not only increases food security, but it makes a tremendous difference for the livelihoods of smallholder farmers, their families, and even their communities,” said Debra Mallowah, Head for Bayer’s Crop Science Division in Africa. By addressing up to 10 million smallholder farmers, the investment significantly helps to advance Bayer’s goal of reaching 21.5 million smallholders in Africa and 100 million globally by 2030.

Investment Is an Important Pillar for Bayer’s Growth Strategy in Africa

While addressing food security challenges in the region and supporting smallholder farmers, the investment also represents a significant business opportunity for Bayer. Africa is one of the fastest-growing markets with substantial agricultural potential. The demand for Bayer’s Dekalb brand hybrids has shown considerable growth over the years, surpassing supply. As such, the site is a key component of Bayer’s growth strategy for Africa, with the aspiration of doubling the Crop Science Division’s business on the continent by 2030.

To this end, another 35 million euros until 2028 are earmarked for further expansion of the seed production network across Sub-Saharan Africa. Bayer’s expertise in maize seed breeding and production holds particular potential because it is a staple food crop in Africa; for instance, in Zambia, a maize meal known as “nshima,” constitutes a significant part of the daily diet, providing 60 per cent of caloric needs.

Bayer to Support the Economy and Local Communities in the Kabwe Area

The new facility is anticipated to stimulate economic growth in the region by creating jobs and business opportunities. Bayer plans to employ 80 permanent staff members and over 100 seasonal workers and contractors at the site. Additionally, approximately 15,000 seasonal on-farm jobs will be generated through Bayer’s field operations and those of contract growers to produce the seeds.

Bayer is committed to being an active member of the communities it operates in. As such, two initiatives to support the communities around Kabwe are underway. The neighborhood next to the new facility will benefit from improved water accessibility and storage through a revived borehole for water supply, a new tank, and pipes, funded by Bayer.

As a life science company, Bayer is also supporting the local healthcare system. Currently, residents living near the site must travel up to 20 kilometers to access the nearest health facility, disproportionately affecting women and children. Based on a Public Private Partnership model in collaboration with Zambia’s Ministry of Health, the Municipality of Kabwe, the NGO Project Concern Zambia, and the local community, Bayer will fund the establishment of a new health center, which aims to provide essential healthcare services to more than 10,000 residents, including Bayer employees and their dependents.

“The new facility will help us improve food security, empower smallholder farmers, and support communities in numerous countries on the African continent. It’s also a great business opportunity for Bayer. We can’t wait to ramp up production," concluded Bill Anderson.

Images of the site can be downloaded here.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.


Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries:
Alexander Gutmann, +49 174 730 6349
Email: alexander.gutmann@bayer.com

Liza Bohlmann, +27 72 209 3584
Email: liza.bohlmann@bayer.com

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would offer significant improvements in the efficacy or safety of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies. Based on a priority review designation, the FDA’s goal is to take action on a New Drug Application within 6 months of submission, compared to 10 months under standard review. This would result in a PDUFA date and a potential approval of Kerendia in the U.S. in heart failure with an LVEF of ≥40% in the third quarter of 2025.

“The FDA’s Priority Review designation reinforces the potential of finerenone to emerge as a new pillar of therapy, advancing the treatment paradigm in heart failure with a left ventricular ejection fraction (LVEF) of ≥40%,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Currently, there are limited treatment options with proven efficacy available to physicians. We are excited about the Priority Review designation for finerenone, as this brings us an important step closer to bringing finerenone to patients as quickly as possible."

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and an LVEF of ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.

The supplemental New Drug Application submitted to the U.S. FDA is based on positive data from the FINEARTS-HF study, which is part of the ongoing MOONRAKER study program with finerenone. Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU, and Japan, and these applications are currently under review. Further regulatory applications to health authorities in other markets worldwide will follow.

About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is currently not approved for the treatment of heart failure.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE.

About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the aging population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

·       Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%

·       Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump

·       Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited guideline-directed treatment options for HF with LVEF ≥40%.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

In the Pharmaceuticals Division, for example, the company expects to increase the combined sales of the cancer drug Nubeqa™ and Kerendia™, for the treatment of chronic kidney disease associated with type 2 diabetes, from around 2 billion euros to more than 2.5 billion euros in 2025, Anderson said. This year, it is also planning to launch the heart drug Beyonttra™ (active ingredient: acoramidis) and elinzanetant, a non-hormonal treatment for menopause symptoms. The Pharmaceuticals Division is projected to return to sales growth from 2027 onwards and expand margins beginning in 2028, he added. Furthermore, the company remains active in its efforts to address the US litigations, both inside and outside the courtroom, with Anderson seeing tangible steps toward containment on the horizon this year. Bayer is committed to significantly containing the related risks by the end of 2026, he explained. In addition, the company remains focused on deleveraging and advancing Dynamic Shared Ownership, Anderson said. The new operating model is expected to deliver savings of 800 million euros for 2025, on top of the approximately 500 million euros in savings that were targeted and achieved in 2024, he added.

The plan to boost profitability at Crop Science centers around key measures regarding the product portfolio, research and development, production, commercial and enabling functions, totaling more than one billion euros in annual earnings contributions by 2029. It also includes a far-reaching cash productivity program. Bayer is targeting above-market growth for Crop Science during the coming years, with more than 3.5 billion euros of incremental sales from innovation by 2029. By the same year, the division is targeting an EBITDA margin before special items in the mid-20s percentage. “We recognize the need to take action, our team has a plan, and they’ve got what it takes to deliver,” Bill Anderson said.

Group sales at prior-year level, free cash flow slightly higher than projected

Group sales came in at 46.606 billion euros in 2024, up 0.7 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). There was a negative currency effect of 1.349 billion euros (2023: 1.964 billion euros). EBITDA before special items decreased by 13.5 percent to 10.123 billion euros. This figure included a negative currency effect of 573 million euros (2023: 375 million euros). EBIT amounted to minus 71 million euros (2023: plus 612 million euros) after net special charges of 5.507 billion euros (2023: 6.977 billion euros). The special charges mainly resulted from impairment losses, which were primarily attributable to the Crop Science Division. Net income came in at minus 2.552 billion euros (2023: minus 2.941 billion euros), while core earnings per share declined by 21.0 percent to 5.05 euros.

Free cash flow more than doubled against the prior year, rising to 3.107 billion euros and slightly exceeding the company’s expectations. Net financial debt amounted to 32.626 billion euros as of December 31, 2024, down 5.4 percent from year-end 2023. In order to further reduce debt and gain greater flexibility, the company intends to pay out the legal minimum in dividends for 2024, as previously announced. It is therefore proposing an unchanged dividend of 0.11 euros per share entitled to the dividend at the Annual Stockholders’ Meeting on April 25, 2025.

Crop Science impacted by lower prices in crop protection business

Sales at Crop Science decreased by 2.0 percent (Fx & portfolio adj.) to 22.259 billion euros. Business was primarily impacted by lower prices in the crop protection business driven by competitive pricing pressure. Lower volumes in seeds and traits due to lower planted area were offset by volume growth in crop protection. Sales in Latin America were down due to lower planted corn area and reduced crop protection prices. By contrast, North America delivered slightly higher sales driven by higher crop protection volumes and soybean planted area, partially offset by lower corn planted area.

EBITDA before special items at Crop Science decreased by 14.2 percent to 4.325 billion euros, mainly due to significant price declines in the crop protection business. Earnings were also impacted by higher provisions for the Group-wide short-term incentive (STI) program as well as inflationary cost increases, whereas the cost of goods sold improved due to efficiencies, especially for crop protection products. There was also a positive currency effect of 37 million euros (2023: 103 million euros). The EBITDA margin before special items declined by 2.3 percentage points to 19.4 percent.

New products drive sales growth at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) rose by 3.3 percent (Fx & portfolio adj.) to 18.131 billion euros. The division’s new products achieved significant gains, with growth rates of 78.2 percent (Fx & portfolio adj.) for Nubeqa™ and 73.9 percent (Fx & portfolio adj.) for Kerendia™. It also posted continued sales growth for the ophthalmology drug Eylea™, with an increase of 5.1 percent (Fx & portfolio adj.), as well as in the Radiology business, largely driven by higher volumes and prices for CT Fluid Delivery and Ultravist™. In addition, sales of the pulmonary hypertension treatment Adempas™ rose by a substantial 10.5 percent (Fx & portfolio adj.), with particularly strong gains in the United States. These positive effects were partially offset by declines for Xarelto™ in particular, with sales of the oral anticoagulant falling 13.0 percent (Fx & portfolio adj.) due to patent expirations.

EBITDA before special items at Pharmaceuticals decreased by 9.0 percent to 4.722 billion euros, mainly due to a negative currency effect of 491 million euros (2023: 221 million euros). Earnings were also impacted by higher provisions for the STI program as well as shifts in the product mix, reflecting declines for Xarelto™ and higher sales for Nubeqa™ and Eylea™ in particular, as well as the related increase in license fees. However, Pharmaceuticals was able to partially offset these effects thanks to lower expenses for projects in advanced clinical development and decreased selling expenses for its more mature products, while simultaneously increasing investments in early-stage research as well as in cell and gene therapy and chemoproteomics technologies. The EBITDA margin before special items decreased by 2.7 percentage points to 26.0 percent.

Consumer Health registers growth (Fx & portfolio adj.) in almost all categories

Sales of self-care products (Consumer Health) rose by 1.9 percent (Fx & portfolio adj.) to 5.870 billion euros against a strong prior year, with gains in almost all categories. Sales growth was strongest at Dermatology, which saw a 9.7 percent increase (Fx & portfolio adj.) that was primarily driven by continued strong demand for Bepanthen™. Business was also up by a substantial 8.2 percent (Fx & portfolio adj.) at Digestive Health, partly thanks to a normalized supply situation. By contrast, the division registered considerable declines in the Allergy & Cold business against a strong prior year, with sales falling 11.5 percent (Fx & portfolio adj.) due to a weaker season and inventory optimization by customers in the United States.

EBITDA before special items at Consumer Health decreased by 3.2 percent to 1.366 billion euros, mainly due to a negative currency effect of 46 million euros (2023: 133 million euros). Thanks to its continuous cost and price management efforts, the division was able to offset an increase in the cost of goods sold and higher investments in marketing and developing products. The EBITDA margin before special items came in at 23.3 percent, down 0.1 percentage points.

Group outlook: 2025 sales roughly at prior-year level

On a currency-adjusted basis (i.e. based on the average monthly exchange rates in 2024), Bayer expects to generate sales of 45 billion to 47 billion euros in 2025. This corresponds to a change of minus 3 to plus 1 percent on a currency- and portfolio-adjusted basis. On a currency-adjusted basis, the company anticipates EBITDA before special items of 9.5 billion to 10.0 billion euros, core earnings per share of 4.50 to 5.00 euros, and free cash flow of 1.5 billion to 2.5 billion euros. Net financial debt as of year-end 2025 is expected to amount to 31.0 billion to 32.0 billion euros on a currency-adjusted basis.

Bayer has also prepared its guidance based on the closing exchange rates as of December 31, 2024, and the differences to the currency-adjusted forecast above are as follows: At Group level, it expects to post EBITDA before special items of 9.3 billion to 9.8 billion euros, core earnings per share of 4.25 to 4.75 euros, free cash flow of 1.3 billion to 2.3 billion euros, and net financial debt of 31.2 billion to 32.2 billion as of year-end 2025.

Sustainability: Top marks for climate and water efforts

Bayer once again made major progress in its sustainability endeavors in 2024. The company is well on track to achieve its three “100 million” targets by 2030, which involve supporting smallholder farmers and providing access to modern contraception as well as self-care products. As part of its Climate Transition and Transformation Plan, Bayer last year defined concrete targets and mapped out the measures it plans to take in order to achieve net zero emissions across its entire value chain by 2050. The Science Based Targets initiative recently confirmed the company’s targets for reducing greenhouse gas emissions and validated its path to net zero. As the most important step in this regard, Bayer will continue its efforts to switch to renewable sources to meet its power and energy needs. In 2024, the company entered into agreements to secure significant amounts of power from renewable energy sources.

Bayer’s sustainability targets and related commitments to supporting people and protecting the environment will continue to be an integral part of its Group strategy moving forward, with the Board of Management having reaffirmed the sustainability strategy at the end of last year. CDP, a prominent non-profit organization, has recognized the company’s efforts in this area, having awarded Bayer the highest score of A in the categories of water and climate.

Notes:

The following tables contain the key data for the Bayer Group and its divisions for the full year and the fourth quarter of 2024.

The complete Annual Report 2024 is available on the internet at: www.bayer.com/annualreport

The speech given by the Bayer Board of Management to the media will be available online from around 10 a.m. CET at: www.bayer.com/speeches

Live broadcast of the Financial News Conference from around 10 a.m. CET and recording available from around 3 p.m. CET at: www.bayer.com/live-mc

Additional information for investors, including presentation charts, and access to the live broadcast of the Investor Video Call (from around 2 p.m. CET) and recording (from around 6 p.m. CET) available at: www.bayer.com/live-ic

Print-quality photos will be available here shortly after the news conference.

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

“The FDA’s decision to grant RMAT designation to AB-1005 is exciting news for people living with Parkinson’s disease and their loved ones,” said Gustavo Pesquin, CEO, AskBio. “This milestone could potentially expedite the development of our important investigational gene therapy program, and it highlights our promising data and the potential of AB-1005 for patients and the medical community. We look forward to working closely with the FDA to accelerate our program.”

The FDA determined that AB-1005, an investigational gene therapy intended to slow disease progression and improve motor outcomes in patients with PD, met the criteria for RMAT designation. This decision follows a review of information and data provided by AskBio, including clinical evidence from the open label, uncontrolled study Phase Ib trial of AB-1005.

AskBio’s 36-month Phase Ib data showed that the administration of AB-1005 was well tolerated with no product-related serious adverse events.¹ Further, the moderate PD cohort showed trends for improvement or stability on several PD-relevant clinical scales at 36 months compared to baseline, including Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and self-reported PD motor diaries, together with trends in reductions in Parkinson’s medications (levodopa-equivalent daily dose [LEDD]).¹ Most participants in the mild PD cohort showed an overall stable clinical status with little change in MDS-UPDRS, the self-reported PD motor diary, or LEDD.¹

RMAT is a designation granted by the FDA to regenerative therapies, including gene therapies, being developed to treat, modify, reverse, or cure serious or life-threatening diseases or conditions.² Investigational products receiving this designation must have produced preliminary clinical evidence indicating that they may have the potential to address unmet medical needs for such diseases or conditions.² RMAT provides recipients with enhanced access to the FDA, which could include intensive guidance on efficient drug development, rolling Biologics License Application (BLA) review, and other actions to expedite review.²

“The RMAT designation for AB-1005 underscores the high unmet medical need and the potential of this investigational gene therapy to make a difference for patients with Parkinson’s disease,” said Christian Rommel, Executive Vice President, Global Head of Research and Development and Member of the Pharmaceuticals Leadership Team at Bayer. “This is the latest example of what can be achieved through the joint commitment of AskBio and Bayer to deliver breakthrough innovation for patients.”

The first participants in the AB-1005 Phase II REGENERATE-PD clinical trial have been randomized in the United States, and the trial is currently recruiting.³ Additional study sites in the United States, Germany, Poland, and the United Kingdom are expected to be opened for enrollment in first half of 2025.³

AB-1005 has not been approved by any regulatory authority, and its efficacy and safety have not been fully established or evaluated.

About Parkinson’s disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function.⁴ Symptoms include tremors, muscle rigidity, and slowness of movement.⁴ Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, congestive issues, and depression.⁴ Symptoms typically intensify over time and make everyday tasks increasingly demanding.⁴ The prevalence of PD has doubled over the past 25 years.⁵ Today, more than 10 million people worldwide are estimated to be living with PD.⁶ This makes it the world’s second most prevalent neurodegenerative disease.⁷ It is also the most frequent movement disorder.^8,9 At present there is no cure, and current treatment options lack the holistic management of symptoms, so new therapies are needed.^10,11

About the AB-1005 Phase Ib trial
In this Phase Ib, multi-center, multi-site, open-label, uncontrolled trial, 11 patients were administered AB-1005 to the putamen via one-time bilateral convection-enhanced delivery. Patients were enrolled into two cohorts, mild (6 patients) and moderate (5 patients), based upon the duration and stage of their PD. The objective of this investigation was to evaluate the safety and potential clinical effect of AB-1005 delivered to the putamen in patients with early/mild or moderate PD. The outcomes assessed at 36 months were incidence of Treatment-Emergent Adverse Events (TEAEs) as reported by the patients or assessed clinically by physical and neurological examinations, motor symptoms as reported via the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and PD Motor Diary self-assessments, non-motor symptoms of PD, and brain dopaminergic network integrity as measured by DaTSCAN.1 These assessments will continue for up to five years. For more information, visit clinicaltrials.gov (NCT#04167540 or askbio.com).

About REGENERATE-PD
REGENERATE-PD is a Phase II, randomized, double-blind, sham-controlled trial of the efficacy and safety of intraputaminal AB-1005 in the treatment of adults (45-75 years) with moderate-stage Parkinson's disease. The trial will include an estimated 87 subjects with trial sites located in the United States, Germany, Poland, and the United Kingdom. For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (NCT06285643), or visit askbio.com.

About AB-1005
AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery.¹² In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons.^13,14 Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as Parkinson’s disease (PD), marked by progressive degeneration of midbrain dopaminergic neurons.¹⁵ Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, we can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.¹⁵

About AskBio
AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. An early innovator in the gene therapy field, with over 900 employees in five countries, the company holds more than 600 patents and patent applications in areas such as AAV production and chimeric capsids. Learn more at www.askbio.com or follow us on LinkedIn.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

AskBio Forward-Looking Statements
This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding AskBio’s clinical trials. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned clinical and regulatory milestones and timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office. Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
 

References:
 

1.     Nicolas M, et al. Preliminary Efficacy of GDNF Gene Therapy (AAV2-GDNF; AB-1005) in Parkinson’s Disease: 36-Month Follow-Up From a Phase 1b Study. Presented at the International Congress of Parkinson’s Disease and Movement Disorders 2024.

2.     Food and Drug Administration. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. Available at: https://www.fda.gov/media/120267/download.  Accessed: February 2025.

3.     AskBio.com. First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease. Available at: https://www.askbio.com/first-participants-randomized-in-askbio-phase-ii-gene-therapy-trial-for-parkinsons-disease/. Accessed: February 2025. 

4.     National Institutes of Health. Parkinson’s Disease Available at: https://www.ninds.nih.gov/health-information/disorders/parkinsons-disease. Accessed: February 2025.

5.     World Health Organization. Parkinson disease. Available at: https://www.who.int/news-room/fact-sheets/detail/parkinson-disease. Accessed: February 2025.

6.     Parkinson’s Foundation. Who has Parkinson’s? Available Parkinson’s Foundation. Who has Parkinson’s? Available at: https://www.parkinson.org/understanding-parkinsons/statistics. Accessed: February 2025.

7.     National Institute of Environmental Health Sciences. Neurodegenerative Diseases. Available at: https://www.niehs.nih.gov/research/supported/health/neurodegenerative. Accessed: February 2025.

8.     World Health Organization. Parkinson disease. Available at: https://www.who.int/news-room/fact-sheets/detail/parkinson-disease. Accessed: February 2025.

9.     Stoker TB, Barker RA. Recent developments in the treatment of Parkinson's Disease. 2020 

10.  Mayo Clinic. Parkinson’s disease. Available at: https://www.mayoclinic.org/diseases-conditions/parkinsons-disease/diagnosis-treatment/drc-20376062. Accessed: February 2025.

11.  Rizek P, An update on the diagnosis and treatment of Parkinson’s disease. 2016.

12.  Heiss JD, et al. Trial of magnetic resonance-guided putaminal gene therapy for advanced Parkinson’s disease. Mov Disord. 2019 Jul;34(7):1073-1078.

13.  Kells AP, et al. Regeneration of the MPTP-lesioned dopaminergic system after convection-enhanced delivery of AAV2-GDNF. J Neurosci. 2010 Jul 14;30(28):9567-77.

14.  Lin LF, Doherty DH, Lile JD, Bektesh S, Collins F. GDNF: a glial cell line-derived neurotrophic factor for midbrain dopaminergic neurons. Science. 1993;260(5111):1130-1132.

15.  Barker RA, et al. GDNF and Parkinson's Disease: Where Next? A Summary from a Recent Workshop. J Parkinsons Dis. 2020;10(3):875-891.

Contact for media inquiries Bayer:
Dr. Imke Meyer, phone +49 (214) 60001275
Email: imke.meyer@bayer.com

Contact for media inquiries AskBio:
Phil McNamara, phone +1 (984) 5207211
Email: pmcnamara@askbio.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of ≥40% in a Phase III study (FINEARTS-HF). Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

“According to estimates, 1.2 million people in Japan are living with heart failure, and 60% of these patients suffer from heart failure with an LVEF of ≥40%, who have a multitude of comorbidities such as hypertension and atrial fibrillation, and a high risk for cardiovascular events, providing a significant challenge for their treating physicians,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “As physicians navigate the complexities of multiple comorbidities, at the same time they are facing a lack of proven treatment options, limiting their ability to help these patients. Finerenone, if approved, has the potential to become a new pillar of treatment for this common form of heart failure, alleviating the burden of serious outcomes in an underserved patient population.”

Heart failure (HF) is a rapidly growing public health issue affecting over 60 million people worldwide. It is the leading cause of hospitalization in people over 65. An estimated 1.2 million people in Japan are affected. As the population ages, the number of patients with HF in Japan continues to increase and is estimated to exceed 1.3 million by 2030. Approximately 60% of these patients suffer from HF with a LVEF of ≥40%, which is associated with multiple comorbidities, making the condition complex to manage.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.

The submission of finerenone to the MHLW is based on positive data from the Phase III FINEARTS-HF study, which is part of MOONRAKER, one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings. Finerenone has also been submitted for marketing authorization in this common form of heart failure in China, the EU, and the U.S., and these applications are currently under review. Further regulatory applications to health authorities in other markets worldwide will follow.

About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is currently not approved for the treatment of heart failure.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE.

About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

• Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%
• Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
• Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“Beyonttra is an important advancement broadening the therapeutic landscape of ATTR-CM, an underdiagnosed, progressive heart disease caused by the destabilization of transthyretin, leading to amyloid buildup in the heart, which can result in heart failure and arrhythmias,” said Marianna Fontana, Professor of Cardiology at University College London (UCL) and Honorary Consultant Cardiologist at the National Amyloidosis Centre, UK. “Ongoing advancements in treatment are important because they have the potential to significantly improve outcomes in this fatal disease. Beyonttra was specifically developed to decelerate symptom progression and improve outcomes in patients with ATTR-CM by providing near-complete stabilization of transthyretin.”

“Heart failure remains one of the most pressing challenges in global healthcare, with conditions like ATTR-CM often an undiagnosed cause. The EU approval of Beyonttra marks an important milestone bringing renewed optimism for patients living with ATTR-CM and offers physicians an additional fast-acting treatment option to protect these vulnerable patients by reducing their risk of cardiovascular events and slowing disease progression,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “We are dedicated to working closely with healthcare providers and regulatory bodies to ensure timely access to this therapy.”

The approval of Beyonttra (acoramidis) in the EU is based on the pivotal results of the ATTRibute-CM study. The Phase III trial investigated the efficacy and safety of acoramidis (compared to placebo) in patients with ATTR-CM. Acoramidis was superior to placebo in reducing the composite of all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH). Acoramidis demonstrated near-complete TTR stabilization thus reducing toxic amyloid precursors and minimizing amyloid formation. In the Phase III ATTRibute-CM study, acoramidis has shown clear benefits on cardiovascular endpoints starting as early as 3 months after treatment initiation.

As a follow-up to the pivotal Phase III study, the OLE (Open-Label Extension) data for acoramidis demonstrated a relative risk reduction in ACM of 34% by 42 months, highlighting its potential to improve long-term survival outcomes. Additionally, the OLE study underscores the early benefit in patients who switched from placebo to acoramidis at 30 months, further underscoring the efficacy of acoramidis in stabilizing TTR and offering a promising treatment option for those living with ATTR-CM.

Following this EU approval, Bayer will launch acoramidis in Europe in the first half of this year. Acoramidis, developed by BridgeBio Pharma, Inc. (Nasdaq: BBIO), was approved by the Food and Drug Administration (FDA) for the U.S. in November 2024 with a label specifying near-complete stabilization of TTR. BridgeBio holds the marketing rights for acoramidis in the U.S., while Bayer holds the exclusive marketing rights for the product in Europe.

Since March 2024, Bayer and BridgeBio have pursued a collaboration for acoramidis in Europe. This partnership leverages Bayer’s long legacy of expertise in cardiovascular disease and its established European cardiovascular infrastructure paired with BridgeBio’s leadership in the emerging field of ATTR-CM. 

About ATTR-CM
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive and fatal disease, characterized by the deposition of abnormal protein in the heart muscle. It occurs when a tetrameric protein called transthyretin (TTR) becomes unstable, caused by an inherited mutation in the TTR gene or due to aging, and dissociates into monomers. These monomers misfold, aggregate, and form amyloid fibrils that deposit in the heart muscle, leading eventually to heart failure. The disease is often diagnosed late, when the accumulation of amyloid has already occurred, and patients are symptomatic. Once diagnosed, ATTR-CM patients have a median survival of 3-5 years if left untreated.

About Beyonttra^™ (acoramidis) and the Phase III study results
Beyonttra^™ is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. Beyonttra was designed to provide effective TTR tetramer stabilization by mimicking a naturally occurring "protective mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. Acoramidis has demonstrated near-complete (≥90%) TTR stabilization, minimizing amyloid formation. In the Phase III ATTRibute-CM study, acoramidis has shown clear benefits on cardiovascular endpoints.

In the Phase III ATTRibute-CM study, acoramidis met the primary endpoint. The trial investigated the efficacy and safety of acoramidis (given twice daily compared to placebo) in patients with ATTR-CM.

When compared to placebo, acoramidis twice daily was superior demonstrating a rapid and sustained clinical benefit on the composite endpoint of all-cause mortality and cardiovascular-related hospitalization (CVH) in ATTR-CM patients through month 30:

• Significant benefit in the primary endpoint
• 36% risk reduction in the combined endpoint of all-cause mortality or first cardiovascular hospitalization vs placebo at 30 months, showing benefits already after starting as early as 3 months of treatment initiation (secondary endpoint)
• 50% relative risk reduction in annualized cardiovascular hospitalizations compared to placebo at 30 months (secondary endpoint)  

Beyonttra is generally well-tolerated.

As a follow-up to the pivotal Phase III study, the OLE (Open-Label Extension) data for acoramidis demonstrated a 34% relative risk reduction in all-cause mortality vs placebo at 42 months highlighting its potential to improve long-term survival outcomes.

About Bayer’s Commitment in Cardiovascular Diseases
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The submission is based on positive three-year results from open-label extension studies of the clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements, with 28% of patients in DME and 24% of patients in nAMD having a last assigned dosing interval of 6 months at the end of three years.

“Longer dosing intervals address a critical unmet medical need and offer patients living with retinal diseases greater flexibility and a reduced burden from frequent injections and hospital visits. This is also important to those that care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Eylea 8 mg was the first anti-VEGF to receive a 5-month label in the EU, and the new data support a substantial proportion of patients have the potential to maintain 6-month extended treatment intervals.”

The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups.

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 85 million applications and more than 12 million patient-years of experience worldwide.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.

About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.

Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar leads to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME affects around 27 million people globally.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

“Treating heart failure with an LVEF of 40% or greater poses unique challenges, leaving patients with few effective therapeutic options,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, finerenone has the potential to become a new pillar in addressing this common form of heart failure, offering hope for improved outcomes in a patient population that has long been underserved."

Heart failure (HF) is a rapidly growing public health issue affecting over 60 million people worldwide and at least 15 million people in Europe alone. Approximately half of these patients suffer from HF with a LVEF of ≥40%, which is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. According to a study, the estimated costs related to heart failure in the EU in one year is about 29 billion Euros. The bulk of the costs is driven by repeat hospitalizations.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.

Finerenone has also been submitted for marketing authorization in this common form of heart failure in the U.S. and in China, and these applications are currently under review. Further regulatory applications to health authorities in other countries worldwide will follow. Submissions are based on positive data from the FINEARTS-HF study, which is part of MOONRAKER, one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is currently not approved for the treatment of heart failure.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE.

About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

• Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%
• Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
• Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“We are successfully delivering on our ambitious business goals despite significant headwinds. At the same time, the value of our pipeline is growing by accelerating breakthrough innovations,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.”

Topline improved and poised for future growth

Bayer continues to strengthen its leadership position in Prostate Cancer with the anticipated launch of a third indication for darolutamide (marketed under the brand name Nubeqa™) in 2025, which is supported by strong data from the ARANOTE trial. Darolutamide plus ADT now has positive data both with and without chemotherapy (docetaxel) based on two pivotal Phase III studies (ARASENS and ARANOTE) in metastatic hormone-sensitive prostate cancer. Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide, in addition to filings in the EU and the U.S. earlier in 2024. Nubeqa achieved blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales. Additionally, Nubeqa is now the fastest growing androgen receptor inhibitor in the U.S., with 100,000 patients treated around the world as of the end of 2024.

In Cardiovascular, Bayer also recently submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and to the CDE of China’s NMPA for finerenone (Kerendia™) in heart failure, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch as early as end of 2025. Filing submissions are supported by data from FINEARTS-HF Phase III trial, where finerenone demonstrated statistically significant cardiovascular benefits in patients with heart failure and a left ventricular ejection fraction of greater than or equal to 40%. The robust data from Kerendia’s clinical development program underscore its potential to become an important therapy for both patients with kidney disease and heart failure.

Additionally, in early 2025, EU approval is anticipated for acoramidis, which demonstrated near-complete stabilization (≥90%) of transthyretin (TTR), for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). This follows positive Committee for Medicinal Products for Human Use (CHMP) opinion in December 2024.

In the area of Women’s Healthcare, elinzanetant marked another significant clinical milestone in early 2025 following three positive Phase III read-outs in 2024 (OASIS 1-3). OASIS 4, the first pivotal international Phase III study evaluating a treatment for vasomotor symptoms (VMS, also known as hot flashes) caused by adjuvant endocrine therapy in women being treated or at high risk for breast cancer, met all primary and key secondary endpoints with elinzanetant, demonstrating statistically significant reductions in the frequency of moderate to severe VMS compared to placebo. Elinzanetant also reduced the severity of VMS and improved sleep disturbances and quality of life. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. With regulatory submissions under review around the world, Bayer anticipates a potential launch this year, aiming for fast market penetration building on Bayer's strength in women's healthcare. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist with potential to transform the management of menopause, broadening treatment choices, and addressing major unmet needs in women’s health.

In Ophthalmology, Eylea 8mg (aflibercept 8 mg) has the potential to become the new standard of care in the treatment of certain exudative retinal diseases. In the global Phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch, hemi-retinal vein occlusion, the primary endpoint at week 36 was met. Patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy Eylea 2 mg (aflibercept 2 mg) every four weeks.

In Radiology, Bayer substantially advanced the development of innovative contrast agents for magnetic resonance imaging (MRI), achieving a significant milestone with its Phase III QUANTI clinical development program. The first data from the program show that the investigational gadolinium-based MRI contrast agent gadoquatrane successfully met the primary and main secondary diagnostic efficacy and safety endpoints in patients using a 60% lower gadolinium dose compared to trial comparators. The QUANTI program showcases Bayer's commitment as a leader in radiology, bringing forward innovation in medical imaging.

Pipeline value improved and early lead positions strengthened

Bayer is making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson’s disease.

Bemdaneprocel will directly advance to Phase III clinical development in Parkinson’s disease, based on positive data from the Phase I exPDite trial. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson's disease.

AB-1005 is advancing in Phase II, with the randomization of participants in the REGENERATE-PD clinical trial focusing on patients with moderate-stage Parkinson's disease. AB-1005 is an investigational AAV-based gene therapy that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially protect and restore dopamine-generating neurons. AB-1005 has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations, highlighting its potential to address significant unmet medical needs.

As part of its transformation, Bayer has sharpened its focus in R&D to build a highly differentiated pipeline for long-term growth in oncology, cardiology and renal diseases, neurology and rare diseases, and immunology. Through rigorous assessment and prioritization, Bayer Pharmaceuticals is now fully focused on the areas of greatest unmet need and highest value potential.

Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipeline. With Vividion’s acquisition of the precision oncology platform company Tavros Therapeutics, Bayer continues to leverage its chemoproteomics platform technology to unlock traditionally undruggable targets with precision small-molecule therapeutics. It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies, and also has IND-enabling programs including a RAS-PIK3CA program for RAS-driven cancers.

Additionally in the field of precision oncology, investigational BAY 2927088, an oral, small molecule, tyrosine kinase inhibitor as a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations, showed promising results as a second line therapy in the ongoing Phase I/II SOHO-01 study evaluating safety and efficacy. Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese Centre for Drug Evaluation (CDE). Beyond the SOHO-01 trial, BAY 2927088 is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the SOHO-02 trial. Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated. The open-label, first-in-human, dose escalation study will evaluate patients with KRAS G12C-mutated metastatic cancer. This innovative approach has the potential to enhance the treatment options available for patients, offering the possibility to reduce or stop tumor progression.

Targeted Radionuclide Therapy (TRT) is a strategic area of focus in Oncology precision drug development at Bayer, building on more than 10 years of real-world experience with Xofigo^TM as the first and only targeted alpha therapy for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes new targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules. ²²⁵Ac-pelgifatamab (BAY 3546828) and ²²⁵Ac-PSMA-Trillium (BAY 3563254), two candidates targeting PSMA (prostate specific membrane antigen), are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer (mCRPC).

In the field of cardiovascular diseases, Bayer is making progress with its Phase II assets. With BAY3283142, an investigational soluble guanylate cyclase (sGC) activator in patients with chronic kidney disease (CKD), Bayer has entered into a Phase II clinical study. By modulating sGC via a heme-independent pathway, the investigational sGC activator now represents a new class of potential future drugs that could offer an advantage in conditions of high oxidative stress such as in diabetic nephropathy.

With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. This antibody specifically blocks the endogenous plasmin inhibitor α2AP leading to the lysis of acute embolic or thrombotic clots without an increase in bleeding. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and will potentially be suitable for treatment in indications of high medical relevance.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Link to live webcast presentation of Bayer AG at J.P. Morgan’s 43rd Annual Healthcare Conference:

Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division will present updates on the company’s pharmaceutical growth strategy and pipeline advancements on Tuesday, January 14, 2025, from 10:30 – 11:10am PST.

Investors, analysts, media professionals and members of the life sciences industry are invited to join the live webcast of the presentation via this link: https://jpmorgan.metameetings.net/events/healthcare25/sessions/58226-bayer/webcast?gpu_only=true&kiosk=true

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“We are thrilled to take this critical step in our development program towards further investigating a potential new therapeutic option for people living with Parkinson’s disease,” said Amit Rakhit, MD, MBA, Chief Development and Medical Officer at BlueRock Therapeutics. “exPDite-2 is the first registrational Phase III clinical trial for an investigational pluripotent stem cell derived therapy in Parkinson’s disease and we look forward to working closely with clinical investigators and the Parkinson’s disease community as we initiate this trial.”

In a Phase I study with 12 participants, bemdaneprocel demonstrated tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The trial is designed to enroll approximately 102 participants with moderate Parkinson’s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to capture objective measures of movement, safety and tolerability, and instruments that capture activities of daily living and quality of life.

The advancement to this registrational trial follows discussions with the U.S. Food and Drug Administration (FDA) under the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2024.

“With the planned initiation of the Phase III clinical trial, we are committed to bringing bemdaneprocel faster to patients in need,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division, and Global Head of Research and Development. “It represents a significant milestone in our efforts to advance our cell and gene therapy pipeline and deliver on our ambition to be an industry leader in this space.”

Depending upon the outcome, the results from this trial are intended to be part of a robust data package to support regulatory submissions for marketing authorization.

About bemdaneprocel (BRT-DA01)
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from pluripotent stem cells that are human embryonic stem cells developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.

About Parkinson’s disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options lack the holistic management of symptoms so new therapies are needed.

About BlueRock Therapeutics LP

BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is expected to begin a Phase III clinical trial in H1 2025. OpCT-001 is expected to begin Phase I clinical testing in H1 2025. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer

Find information at www.bluerocktx.com
Follow us on LinkedIN: www.linkedin.com/company/bluerocktx

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries Bayer:
Dr. Imke Meyer, phone +49 (214) 3021253
Email: imke.meyer@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Contact for media inquiries BlueRock Therapeutics:
Jeff Lockwood, phone +1 (617) 510 6997 
Email: jlockwood@bluerocktx.com

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with this common form of HF in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

“Heart failure represents a serious global health challenge, particularly for patients with a left ventricular ejection fraction of ≥40%, who are difficult to treat”, said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, finerenone could emerge as a new pillar of treatment for this common form of heart failure, offering the potential to improve cardiovascular outcomes for patients who currently have limited treatment options with proven efficacy.”

Heart failure (HF) affects over 60 million people worldwide and is a rapidly growing public health issue. Approximately half of these patients suffer from HF with a LVEF of ≥40%. HF with a LVEF ≥40% is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.

The New Drug Applications submitted to the U.S. FDA and to the CDE of China’s National Medical Products Administration are based on positive data from the FINEARTS-HF study, which is part of one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is not approved for the treatment of heart failure.

The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE.

About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

• Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%
• Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
• Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

“Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed the efficacy and safety for the treatment moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, Head of Research and Development and Member of the Executive Committee of Bayer’s Pharmaceuticals Division. “Importantly, OASIS 4 is the first pivotal international study to assess the safety and efficacy of a non-hormonal treatment approach for women with or at high risk of breast cancer who are suffering from VMS caused by adjuvant endocrine therapy, reaffirming our commitment at Bayer to advancing innovative treatments for the different needs of women and their health.”

Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020, with nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen or aromatase inhibitors) for up to 10 years substantially reduces the breast cancer mortality rate throughout the 2 decades after diagnosis.⁴ Adjuvant endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. VMS (also referred to as hot flashes) is a common adverse reaction of the adjuvant endocrine therapy, which may affect quality of life and treatment compliance, with potential impact on recurrence and long term outcomes⁵. There is unmet medical need for an effective non-hormonal treatment for VMS caused by adjuvant endocrine therapy as currently no approved treatment options are available.

“For women undergoing endocrine therapy against breast cancer, menopausal symptoms like VMS and sleep disturbances are very common and can significantly affect quality of life, potentially impacting treatment adherence,” said Dr. Fatima Cardoso, Principal Investigator of OASIS 4, from Lisbon, Portugal. “The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.”

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer, administered orally once daily. OASIS 4 (NCT05587296) is the first pivotal international Phase III study to assess the safety and efficacy of a non-hormonal treatment of moderate to severe VMS caused by adjuvant endocrine therapy. It is the fourth Phase III study in the OASIS clinical development program with positive topline results, with details planned to be presented at upcoming scientific congresses. Data from OASIS 1 and 2 were published in the Journal of the American Medical Association (JAMA)³ in August 2024. Detailed results of the Phase III study OASIS 3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS 4 is a double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and optionally for an additional 2 years in women with, or at high risk for developing hormone-receptor positive breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.

About Elinzanetant
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1, 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or adjuvant endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by adjuvant endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Menopausal symptoms can also be the result of surgical or medical treatment. Addressing the symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:
1 Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-findingclinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246. 
2 Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505. 
3 https://jamanetwork.com/journals/jama/fullarticle/2822766
4 Davies et al. Lancet 2013 
5 Pistilli et al. J Clin Oncol 38:2762-2772 

 

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

“Renewable fuels are playing an important role in the decarbonization of transportation and energy while global targets continue to shape biofuel markets and accelerate demand for biomass-based feedstocks going forward,” said Frank Terhorst, Head of Strategy & Sustainability for Bayer’s Crop Science Division. “We are committed to supporting farmers’ ability to deliver low-carbon feedstocks on demand, through investments in new crops like winter canola and advancements in sustainable cropping systems.”

Bayer aims to launch hybrid TruFlex winter canola in 2027. It offers many benefits to farmers as it includes Roundup Ready and pod shatter resistance technology, delivering excellent product stability and performance. Used as a new alternative rotational crop, winter canola helps sequester carbon in the soil and can improve soil health by increasing its organic matter content and water-holding capacity, leading to enhanced soil fertility and productivity.

“We are excited to partner with Neste to enable profitable new crop options for farmers, while delivering on the unmet demand for renewable fuel,” said Jennifer Ozimkiewicz, Head of Crop Strategy Soy & Biofuels at Bayer’s Crop Science Division. “We believe our next generation TruFlex products will provide farmers a new profitable rotational crop option, while offering potential sustainability benefits such as increased biodiversity, soil health and agronomic rotation to reduce pest, disease and weed pressure. Bayer is committed to continue to lead the way with alternative biomass-based feedstocks and regenerative agricultural solutions.”

Leading up to launch, Bayer will work with Neste, the value chain, and farmers to introduce winter canola as a biomass-based feedstock that delivers fuel with lower carbon intensity than traditional fuel sources. Bayer and Neste expect to finalize a definitive agreement in 2025.

“This collaboration with Bayer strengthens our strategy to develop together with value chain partners regenerative agriculture concepts that can be scaled up and can play an important role in diversifying and growing the raw materials pool for all of our renewable products,” said Artturi Mikkola, Senior Vice President Feedstock Sourcing & Trading at Neste. “We believe winter canola can bring environmental benefits to cropping systems and result in lower carbon intensity feedstocks that help replace fossil resources with renewable raw materials.”

Renewable fuels play a key role in decarbonizing the transportation sector as electrification will take time in the hard-to-abate sectors, such as aviation. Renewable fuels have a lower carbon intensity than fossil fuels and can significantly reduce greenhouse gas emissions over the life cycle compared to traditional fossil fuels, playing a key role in mitigating climate change. On top, they can provide farmers with new revenue streams through the cultivation of biomass-based feedstocks.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

About Neste
Neste (NESTE, Nasdaq Helsinki) uses science and innovative technology to transform waste and other resources into renewable fuels and circular raw materials. The company creates solutions for mitigating climate change and accelerating a shift to a circular economy. Being the world’s leading producer of sustainable aviation fuel (SAF) and renewable diesel and a forerunner in developing renewable and circular feedstock solutions for polymers and chemicals, the company aims to help its customers to reduce their greenhouse gas emissions by at least 20 million tons annually by 2030.

The company’s ambition is to make the Porvoo oil refinery in Finland the most sustainable refinery in Europe. Neste is committed to reaching carbon-neutral production by 2035 and will reduce the carbon emission intensity of sold products by 50 percent by 2040. Neste has also set high standards for biodiversity, human rights and the supply chain. The company has consistently been included in the CDP and the DJSI lists of the world’s most sustainable companies. In 2023, Neste's revenue stood at EUR 22.9 billion. Read more: www.neste.com

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact for media inquiries:

Bayer (global)
Alexander Hennig, +49 175 3089736
Email: alexander.hennig@bayer.com

Bayer (US)
Kyel Richard, +1 573 3560241
Email: kyel.richard@bayer.com

Neste
Media Service, +358 800 94025
Email: media@neste.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Find more information at www.bayer.com.

Aflibercept 8 mg was well tolerated, and its safety profile was consistent with previous clinical trials.

“These encouraging data demonstrate that aflibercept 8 mg has the potential to become a new standard of care in the treatment of exudative retinal diseases including patients living with retinal vein occlusion, which is known to have a high VEGF load,” said Professor Richard Gale, Clinical Director at York Teaching Hospital, UK.

“The successful outcome of the study establishes the capacity of aflibercept 8 mg to provide sustained disease control,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “Aflibercept 8 mg delivers rapid and resilient fluid control and allows long treatment intervals with vision gains and tolerability comparable to Eylea 2 mg.”

In QUASAR the vast majority of aflibercept 8 mg patients (approximately 90%) were extended to every 8-week dosing and maintained their interval through 36 weeks. Almost 70% were assigned every 12-week dosing at the week 32 visit, potentially further alleviating the burden associated with frequent injections. Aflibercept 8 mg also demonstrated rapid and robust reduction of fluid in the retina similar to Eylea 2 mg, as measured by changes in central subfield thickness (CST) from baseline through week 36. Reduction of fluid in the retina and reducing CST are associated with disease control. The mean number of injections through week 36 was reduced to 6.1 or 6.9 injections with aflibercept 8 mg dosed every 8 weeks (following 3 or 5 initial monthly doses) versus 8.8 injections with Eylea 2 mg dosed every 4 weeks. Despite fewer injections, aflibercept 8 mg every 8 weeks achieved similar efficacy and safety to Eylea 2 mg every 4 weeks at week 36.

Detailed results will be submitted to regulatory authorities worldwide and presented at upcoming medical meetings.

Aflibercept 8 mg is approved in more than 50 countries for the indications neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) under the brand name Eylea^TM 8 mg. Eylea 8 mg became the first anti-VEGF treatment approved in major markets such as the EU and UK for treatment intervals of up to 5 months in DME and nAMD. In the EU and further countries. Eylea 8 mg is available in a vial and a pre-filled syringe that simplifies the accurate delivery of the recommended dose.

Eylea 8 mg (aflibercept 8 mg; in the United States and Canada: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg following any regulatory approvals.

About QUASAR
The QUASAR trial is a global randomized, double-masked, active-controlled phase III study evaluating the efficacy and safety of Eylea 8 mg used with extended dosing intervals in treatment-naïve patients with macular edema secondary to retinal vein occlusion including central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO) and hemiretinal vein occlusion (HRVO). The primary endpoint of this study is to document change in best corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from the date of randomization through 36 weeks of treatment. The study compares BCVA changes between patients who received Eylea 8 mg every 8 weeks following either 3 or 5 initial monthly doses compared to Eylea 2 mg every 4 weeks. Treatment intervals could be further adjusted based on treatment response continuously evaluated under clinically relevant dose regimen modification (DRM) criteria. Treatment intervals could be shortened by 4 weeks at any dosing visit if patients met DRM criteria. Treatment intervals could be extended based on DRM criteria from week 32 (for the study arms with aflibercept 2 mg and aflibercept 8 mg following 3 initial monthly doses) or week 40 (for the study arm with aflibercept 8 mg following 5 initial monthly doses). Patients will be treated up to week 60 followed by a monitoring period until week 64. The trial has enrolled more than 800 patients from 27 countries.

About RVO
Retinal vein occlusion (RVO) is a chronic condition that currently affects 28 million adults globally and can lead to sudden, rapid vision loss. There are two main types of RVO – central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve. BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. RVO leads to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein can cause fluid and blood to leak into the retina resulting in a swelling and bleeding of the macula, the center of the retina responsible for fine vision. This swelling is called macular edema, and VEGF plays a major role in driving this pathology.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The positive CHMP opinion for acoramidis is based on the pivotal ATTRibute-CM study results. The study investigated the efficacy and safety of acoramidis given twice daily compared to placebo, in patients with ATTR-CM.¹ In the ATTRibute-CM Phase III study, acoramidis was superior to placebo in reducing the composite of all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH).¹

“ATTR-CM is often delayed in its recognition or is misdiagnosed, which can have a negative impact on patients’ outcomes. It is a condition that invariably progresses in the absence of treatment, and is ultimately fatal,” said Julian Gillmore, Professor of Medicine, University College London (UCL) Centre for Amyloidosis, UK. “The CHMP's positive opinion offers hope to individuals living with ATTR-CM. We are encouraged by the prospect of additional treatment, which provides near-complete stabilization of TTR, to slow the progression of symptoms and improve outcomes in patients with ATTR-CM.”

“Patients living with ATTR-CM often see a decline in their quality of life due to the physical and functional challenges posed by their condition. There is a clear need for continued innovation and further options for patients affected,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This positive recommendation from the CHMP represents a significant milestone in the fight against this life-threatening heart disease. We eagerly anticipate the European Medicines Agency's approval for acoramidis, expected in early 2025 and are striving to make this new treatment available to patients as soon as possible.”

The final decision from the European Commission on the marketing authorization is expected in the coming months. Acoramidis, developed by BridgeBio Pharma, Inc. (Nasdaq: BBIO), was recently approved by the Food and Drug Administration (FDA) for the U.S. with a label specifying near-complete stabilization of TTR.³ BridgeBio holds the marketing rights for acoramidis in the U.S., while Bayer holds the exclusive marketing rights for the product in Europe. Pending approval, Bayer plans to launch acoramidis in Europe in the first half of 2025.

Since March 2024, Bayer and BridgeBio and affiliates, have pursued a collaboration for acoramidis. This partnership leverages Bayer’s long legacy of expertise in cardiovascular disease and its established European cardiovascular infrastructure paired with BridgeBio’s leadership in the emerging field of ATTR-CM. 

About ATTR-CM
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive and fatal disease in elderly adults, characterized by the deposition of abnormal protein in the heart. It occurs when a tetrameric protein called transthyretin (TTR) becomes unstable, caused by an inherited mutation in the TTR gene or due to aging, and dissociates into monomers. These monomers misfold, aggregate, and form amyloid fibrils that deposit in the heart muscle, leading eventually to heart failure. The disease is often diagnosed late, when the accumulation of amyloid has already occurred, and patients are symptomatic. Once diagnosed, ATTR-CM patients have a median survival of 3-5 years if left untreated.⁴

About Acoramidis and the Phase III study results
Acoramidis is an investigational, orally administered, highly potent selective small molecule stabilizer of transthyretin (TTR). Acoramidis was designed to mimic a naturally occurring "rescue mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. In vitro, acoramidis, demonstrated near-complete (≥90%)² TTR stabilization. In the Phase III study ATTRibute-CM, acoramidis has been shown clear benefits on cardiovascular endpoints.

In the ATTRibute-CM Phase III study, acoramidis met the primary endpoint. The primary objective of the ATTRibute-CM Phase III study was to establish superiority of acoramidis versus placebo on a hierarchical endpoint that included all-cause mortality (ACM) and cumulative frequency of cardiovascular-related hospitalizations (CVH).

When compared to placebo, acoramidis twice daily demonstrated a rapid and sustained clinical benefit on the composite endpoint of all-cause mortality and cardiovascular hospitalization in ATTR-CM patients through month 30⁵:

•Significant benefit in the primary endpoint

• 36% reduction in the combined endpoint of all-cause mortality or first cardiovascular hospitalization, showing benefits already after 3 months of treatment

• 50% reduction in cardiovascular hospitalizations

• 45% of individuals, relative to placebo with 9% experienced a reduction (improvement from baseline) in NT-proBNP⁵

• 40% of individuals, relative to placebo with 22% experienced an increase (improvement from baseline) in 6-minute walk distance⁵

Acoramidis was well-tolerated.⁶

About Bayer’s Commitment in Cardiovascular Diseases
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1.     Gillmore JD, Judge DP, Cappelli F, Fontana M, Garcia-Pavia P, Gibbs S, Grogan M, Hanna M, Hoffman J, Masri A, Maurer MS. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. New England Journal of Medicine. 2024 Jan 11;390(2):132-42.

2.     Miller M, Pal A, Albusairi W, Joo H, Pappas B, Haque Tuhin MT, Liang D, Jampala R, Liu F, Khan J, Faaij M. Enthalpy-driven stabilization of transthyretin by AG10 mimics a naturally occurring genetic variant that protects from transthyretin amyloidosis. Journal of medicinal chemistry. 2018 Aug 22;61(17):7862-76.

3.     Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients

4.     Dungu JN, et al. Cardiac transthyretin amyloidosis. Heart. 2012 Nov 1;98(21):1546-54.

5.     BridgeBio. BridgeBio presents detailed positive results from Phase 3 ATTRibute-CM study of acoramidis for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) at European Society of Cardiology Congress 2023. Available at: https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-presents-detailed-positive-results-phase-3-attribute [November 2024]

6.     BridgeBio. bridgebio pharma presents cardiac magnetic resonance (cmr) imaging evidence consistent with clinical improvement observed in the attribute-cm phase 3 study in patients with transthyretin amyloid cardiomyopathy (attr-cm). Available at: https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-presents-cardiac-magnetic-resonance-cmr-imaging [November 2024].