01
April
2026
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13:00 PM
Europe/Amsterdam

Bayer’s strongest-ever pharma portfolio and promising pipeline drive future growth

Not intended for U.S. and UK Media

Summary

Five growth catalysts fuel the pharma portfolio of Bayer / Record-breaking 2025 with five first-approvals (three new product approvals; two new indications) and six positive Phase III readouts / Multiple key pipeline milestones expected in 2026 in priority therapeutic areas / Bayer confirms dual ambition for Pharmaceuticals to return to mid-single-digit growth from 2027 onwards, and from 2028 to achieve an operating margin expansion towards 30 percent by 2030

Berlin, April 1, 2026 – On the occasion of Bayer’s Pharma Media Day 2026, Stefan Oelrich, Member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division, revealed how a sustained focus on science- and business-prioritization is driving a projected growth trajectory towards 2030.

“With our unwavering focus on our strategic priorities and scientific rigor, we are seeing the rewards of our transformative strategy to drive growth,” said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division. “Thanks to our strongest ever Pharma portfolio, our multimodal pipeline, and an increasingly AI-enabled operating model, we are on track to return to mid-single-digit growth from 2027 onwards, and to expand our margin from 2028 towards 30 percent by 2030.”

Five growth catalysts to drive Pharmaceuticals’ performance into the next decade

“Our intention is to be first- or best-in-class because patients deserve no less,” said Christine Roth, Executive Vice President, Global Head of Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “The bold choices we’ve made over the past few years, along with our empowered teams, are accelerating innovation and delivering real impact for patients and for Bayer.”

ASUNDEXIAN (Development Candidate)

Latest updates
  • Bayer has a factor XIa-inhibitor in clinical development. Asundexian has demonstrated superiority in reducing ischemic stroke, compared to placebo, when both were combined with antiplatelet therapy, in patients who experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
  • Asundexian has received Fast Track Designation from the U.S. Food and Drug Administration (FDA).
  • Factor XIa is a protein in the blood coagulation pathway. The goal of inhibiting Factor XIa is to uncouple hemostasis from thrombosis, thus preventing pathological clot formation while leaving hemostasis intact.1,2,3
  • To date, asundexian has not yet been approved by any health authority for use in any country, for any indication.
Why this mattersAround 12 million people worldwide experience a stroke each year,4 of which 80 percent are ischemic strokes.5 Approximately one in five ischemic stroke survivors will have another stroke within five years, even with available secondary stroke prevention strategies.6

DAROLUTAMIDE / NUBEQA™

Latest updates
  • Darolutamide is the first androgen receptor inhibitor (ARi) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), with or without chemotherapy.
  • Bayer’s ambition is to globally lead this second generation class of ARis.
  • Looking ahead, a Phase III trial is evaluating darolutamide plus ADT vs ADT alone in HSPC, in patients with high-risk biochemical recurrence (BCR) with no evidence of metastatic disease by conventional imaging and a positive positron emission tomography / computer tomography (PSMA PET/CT) at baseline.
  • Darolutamide has a unique chemical structure. It inhibits the receptor function of androgens (male hormones) and through this inhibits the growth of prostate cancer cells.
Why this mattersProstate cancer is the second most common cancer in men.7 In 2022, almost 400,000 men died from the disease worldwide.8

FINERENONE / KERENDIA™

Latest updates
  • Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist (nsMRA), and the first drug targeting the MR pathway that has demonstrated clinically proven heart and/or kidney benefits in five pivotal Phase III studies in patients with:

o   Heart failure with left ventricular ejection fraction (LVEF) ≥40%
o   Chronic kidney disease (CKD) associated with type 2 diabetes
o   CKD associated with type 1 diabetes
o   CKD of non-diabetic causes

  • Based on its proven outcomes in heart and kidney disease, we expect finerenone to become an important pillar within comprehensive care.
  • Finerenone is marketed as Kerendia™ or in selected countries as Firialta™, and is approved in more than 100 countries worldwide for the treatment of adult patients with CKD associated with type 2 diabetes. In the U.S., in the EU, in Japan and some other markets, finerenone is also approved for the treatment of heart failure (HF) with LVEF ≥40%. Applications in HF in additional markets, including China, are under review.
  • The clinical study program with finerenone currently comprises ten Phase III studies with dedicated programs in heart failure (HF) and CKD, respectively, five of which have been completed.
  • Finerenone is a selective nsMRA with a distinct mode of action addressing the inflammatory and fibrotic disease pathophysiology involved in both heart and kidney disease.
Why this mattersMore than 875 million people globally are affected by CKD and/or HF,9,10 with the likelihood of developing both conditions escalating due to global lifestyle trends, an aging population, and the rising incidence of diabetes.9,11,12,13,14 Patients suffering from either CKD or HF face lower survival rates, and the risks of hospitalization, disease progression, and death increase when both conditions coexist.15

ACORAMIDIS / BEYONTTRA™

Latest updates
  • Beyonttra is 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 transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
  • Bayer is striving for a rapid and sustained market-uptake of Beyonttra in ATTR-CM-treatment in Europe.
  • Beyonttra is approved in the EU for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).16
Why this mattersATTR-CM is an often underdiagnosed, progressive potentially fatal heart disease caused by the destabilization of transthyretin (TTR). This destabilization leads to the deposition of amyloid in the heart, which can result in significant impairments in heart function.17,18 ATTR-CM is estimated to affect 400,000 people globally19 and approximately 190,000 people in Europe.20

ELINZANENTANT / LYNKUET™

Latest updates
  • Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK‑1 and NK‑3 antagonist).
  • Elinzanetant is approved under the brand name Lynkuet™ in the U.S. and other markets for the treatment of vasomotor symptoms (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, making it the only approved option in the EU in this indication.
  • Increasing evidence shows that declining estrogen activity leads to hyperactive kisspeptin, neurokinin B, and dynorphin (KNDy) - which express NK1 and NK3 receptors - leading to dysregulation of the centers that regulate temperature and sleep, resulting in VMS.
  • Elinzanetant works by antagonizing the NK1 and NK3 receptors, reducing frequency and severity of VMS, with additional benefits on improving sleep disturbance and quality of life.
Why this mattersBy 2030, the global population of women experiencing menopause is forecast to increase to 1.2 billion, with menopause affecting women at a time where they are very active socially and professionally.21 In 2020, there were 2.3 million new cases of breast cancer globally, and nearly 70 percent of tumors being hormone-receptor positive, requiring anti-estrogen treatment which may trigger menopause symptoms.22,23,24,25

Rejuvenated pipeline fuels future growth

“Our rigorous strategy to rejuvenate our pipeline with innovative and differentiated assets is showing its potential, as seen in our record performance in 2025. Three new product approvals, two new indications for our growth drivers, as well as six positive Phase III readouts,” said Christian Rommel, Executive Vice President, Global Head of Research and Development and Member of the Pharmaceuticals Leadership Team. “In 2026, we anticipate several key milestones further validating our strategy of impact-by-innovation, such as precision medicine in our core therapeutic areas of cardiovascular and oncology, regenerative cell and gene therapies, as well as in molecular imaging.”

Advancements in precision drug development

225Ac-PSMA-Trillium (BAY 3563254)

Latest updates
  • 225Ac-PSMA-Trillium (BAY 3563254) is an investigational targeted alpha therapy (TAT) for patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
  • Encouraging results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study support advancing 225Ac-PSMA-Trillium to the next phase of clinical development.
  • TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC.
Why this mattersProstate cancer is the second most common cancer in men worldwide7 with less than three years median overall survival among metastatic patients, who have developed castration-resistance.26,27

‘‘Small molecule medicines remain one of the most effective ways to deliver impactful therapies through their accessibility, predictability, and global scalability,” said Aleksandra Rizo, M.D, Ph.D, President and CEO, Vividion Therapeutics. “We are advancing oral therapies for cancer and immunologic diseases that target drivers previously considered undruggable, enabled by our chemoproteomics screening platform. With three internally developed molecules now in clinical development, we are focused on translating this work into potentially transforming new medicines for patients.”

WRN inhibitor (VVD-214)

Latest updates
  • WRN inhibitor (VVD-214) is a novel covalent, irreversible inhibitor of the enzyme Werner helicase (WRN) designed to exploit the dependency of microsatellite instability (MSI)-high cancer cells on WRN-mediated DNA repair. This cancer-specific mechanism has the potential to impact disease progression and improve patient survival with limited toxicity and side effects. It was the first covalent inhibitor of WRN to enter clinical trials worldwide.
  • In a Phase I clinical trial VVD-214 was well tolerated and showed promising signs of activity in patients with MSI-high solid tumors.
  • The company plans to continue the Phase Ib and initiate Phase II clinical trials evaluating VVD-214 in patients with advanced MSI-high or dMMR colorectal cancer.
Why this mattersColorectal cancer (CRC) is the third most common cancer worldwide, with nearly two million new cases diagnosed each year.28 Approximately 15 percent of CRC tumors are MSI-high,29 representing the largest MSI-high patient population and a significant opportunity for targeted therapies. VVD-214 also has potential for therapeutic benefit in other MSI-high cancers, including endometrial, ovarian, and gastric.

GIRK4 inhibitor (BAY 3670549)

Latest updates
  • GIRK4 inhibitor (BAY 3670549) is a highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).
  • GIRK4 inhibitor derives from the strategic research alliance with the Broad Institute of MIT and Harvard.
  • Phase I study initiated.
Why this mattersAFib is the most common type of cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure.30,31,32

Sevabertinib

Latest updates
  • Sevabertinib is a new oral, reversible Tyrosine Kinase Inhibitor (TKI) which blocks certain enzymes called tyrosine kinases involved in the growth of cancer cells.
  • Sevabertinib has Breakthrough Therapy Designation in the U.S. and China as a first-line treatment for patients with HER2-mutant non-small cell lung cancer (NSCLC).
  • HER2-mutant NSCLC is approved in the U.S. and Canada under the brand name Hyrnuo™ for adults with previously treated advanced HER2-mutant NSCLC.
Why this mattersNSCLC is the most common type of lung cancer, accounting for more than 85 percent of cases,33 2-4 percent of which represent HER2-mutant NSCLC.34,35

Gene therapy and cell therapy portfolios with potential to deliver transformative patient impact

Gene Therapy

“By combining AskBio’s integrated Adeno Associated Virus platform - from capsid innovation to manufacturing - with Bayer’s global development and operational capabilities, we are working to develop medicines with the potential to transform patient lives across both rare and more common diseases,” said Gustavo Pesquin, Chief Executive Officer, AskBio.

AB-1002

Latest updates
  • AB-1002 is a single-dose investigational gene therapy being developed as a potential treatment for heart failure with reduced ejection fraction (HFrEF).
  • The final participant has been randomized in the Phase II study.
Why this mattersAn estimated 64 million people worldwide are living with heart failure. Despite advances in treatment, mortality and morbidity remain very high.36,37

Ametefgene parvec (AB-1005)

Latest updates
  • Ametefgene parvec is an investigational one-time gene therapy designed to address the underlying biology of Parkinson’s Disease (PD), aiming to restore neuronal function and potentially slow disease progression.
  • An ongoing Phase II trial enrolls participants across clinical centers in the U.S., Germany, Poland and the U.K.
Why this mattersThe prevalence of PD has doubled over the past 25 years. Almost 12 million people live with PD globally. The effect of existing treatment options commonly fades after some years, and motor-fluctuations and treatment-dependent dyskinesia occur.38,39

Cell Therapy

“For diseases characterized by irreversible cell loss, regenerative medicine offers a fundamentally new approach,” said Seth Ettenberg, President and CEO of BlueRock Therapeutics. “We are advancing novel cell therapies into clinical development along with scalable, reproducible manufacturing.”

Bemdaneprocel

Latest updates
  • Bemdaneprocel is a single-dose investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s Disease (PD).
  • Bemdaneprocel is currently under evaluation in a Phase III study across clinical centers in the U.S., Canada and Australia.
Why this mattersThe prevalence of PD has doubled over the past 25 years. Almost 12 million people live with PD globally. The effect of existing treatment options commonly fades after some years, and motor-fluctuations and treatment-dependent dyskinesia occur.38,39

OpCT-001

Latest updates
  • OpCT-001 is an investigational induced pluripotent stem cell (iPSC) derived photoreceptor cell therapy for the treatment of primary photoreceptor diseases.
  • OpCT-001 has received U.S. FDA Fast Track designation and is progressing in its Phase I/IIa study. The U.S. FDA granted OpCT-001 Orphan Drug Designation for treating retinitis pigmentosa.
Why this mattersPrimary photoreceptor diseases are a subgroup of inherited retinal disorders, leading to irreversible vision loss in children and adults. Limited treatment options currently exist for treating primary photoreceptor diseases which affect an estimated 110,000 people in the U.S. alone.40,41,42

Advancing innovation across Medical Imaging

“Medical imaging is rapidly evolving to become more personalized and integrated into the patient’s journey,” said Konstanze Diefenbach, Head of Radiology R&D at Bayer. “At Bayer, we are pioneering the innovations that drive this evolution – from low-dose contrast agents and smarter, connected workflows to new molecular approaches. By enabling earlier, more accurate diagnosis, we empower clinicians to select precise treatment and improve care for their patients.”

Gadoquatrane

Latest updates
  • Gadoquatrane is a next-generation high relaxivity low-dose macrocyclic gadolinium-based MRI contrast agent for detecting and visualizing pathologies in all body regions and the central nervous system in adults and pediatric patients including newborns.
  • Gadoquatrane delivers the lowest gadolinium dose of all macrocyclic MRI contrast agents, with an up to 60 percent gadolinium reduction per procedure compared to current options on the market while maintaining image quality.
  • Bayer announced in March 2026 the world’s first approval in Japan under the brand name Ambelvist™. Further submissions to health authorities worldwide are underway.
Why this mattersMRI contrast agents support diagnosis, inform treatment, and enable monitoring of a vast variety of diseases. A low-dose MRI contrast agent matters because of reducing patients’ lifetime gadolinium exposure. Health authority guidance and medical societies consistently recommend the lowest gadolinium dose required to achieve diagnostic goals. This is relevant for all patients and particularly for those requiring multiple MRI examinations, for example with chronic conditions like cancer, as well as for those with renal impairment and for children. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide.43

Molecular Tracers T-01 and AT-05

Latest updates
  • AT-01 and AT-05 are investigational non-invasive pan-amyloid molecular imaging agents specifically designed to detect amyloid deposits with high sensitivity and specificity, supporting accurate diagnosis of cardiac as well as other types of systemic amyloidosis.
  • By entering into diagnostic tracers, Bayer reinforces its ambition to expand in molecular imaging, while bolstering its position in precision cardiology.
  • AT-01 (124-Iodine evuzamitide) is a PET (Positron Emission Tomography) tracer and the first amyloid-deposit imaging agent to receive U.S. FDA Breakthrough Therapy Designation for cardiac amyloidosis and has Orphan Drug status in both the U.S. and EU, with its Phase III study having completed dosing.
  • AT-05 (99mTc-p5+14) is a SPECT (Single Photon Emission Computed Tomography) tracer currently in Phase I that has the potential to broaden diagnostic options.
Why this mattersWith new therapies emerging for often insufficiently treated conditions, it becomes increasingly relevant to precisely detect and monitor diseases on the molecular level. The development of AT-01 and AT-05 has the potential to address the urgent need for earlier and accurate diagnosis of systemic and specifically cardiac amyloidosis, a currently underdiagnosed and often fatal heart disease that affects more than 400,000 people globally.44,45

Boosting R&D productivity by synergizing in-house AI with strategic partnerships

“Our ambition is to leverage AI to increase R&D productivity by 40 percent by 2030,” said Sai Jasti, Senior Vice President, Head of Data Science & Artificial Intelligence, Bayer Pharmaceuticals R&D. “By integrating AI platform architecture with anonymized patient-centric data, our data scientists are empowered to maximize our in-house biologics portfolio, validate AI models, and scale solutions, thereby ultimately speeding up drug discovery.”

Bayer’s strategic partnerships with organizations Vanderbilt University Medical Center in the U.S., FinnGen in Finland, and PRECISE in Singapore, leverage a global ecosystem that combines anonymized data and AI-driven analytics, expediting drug discovery in critical areas like cardiovascular and renal diseases.

Bayer has also recently signed a partnership with Cradle, a company whose platform is designed to compress development timelines and advance higher-quality molecules into clinical development with greater speed and precision.

Across the value chain, AI is increasingly becoming an integral part of Bayer’s operations. From end-to-end planning across products and worldwide markets to a next-generation suite of agentic tools, employees are empowered with AI-enabled ways of working.

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.

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.

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.

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44 Kim M, et al. Comparative Outcomes of a Transthyretin Amyloid Cardiomyopathy Cohort Versus Patients With Heart Failure With Preserved Ejection Fraction Enrolled in the TOPCAT Trial. J Am Heart Assoc. 2023;12(15):e029705. https://doi.org/10.1161/JAHA.123.029705.

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Contact for media inquiries:

Strategic Communications
Krysia Sommers, phone +49 175 3058308
Email: krysia.sommers@bayer.com

Product Communications
Astrid Kranz, phone +49 30 221541596
Email: astrid.kranz@bayer.com

R&D Communications
Julia Schulze, phone +49 175 5866432
Email: julia.schulze@bayer.com

Cell & Gene Therapy Communications
Imke Meyer, phone +49 214 60001275
Email: imke.meyer@bayer.com

Radiology Communications
Anna Koch, phone +49 160 5873010
Email: anna.koch@bayer.com

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