Slowly but steadily, Bayer is starting to emerge from under the cloud cast by litigation over the weed killer.

By Christiane Truelove • chris.truelove@medadnews.com

Bayer

51368 Leverkusen, Germany

+49 214 30-1 • bayer.com

Best-selling pharma products

All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2021: €1.183. 

2021 sales

• Xarelto $5,602 
• Eylea $3,452 
• Mirena, Kyleena, Jaydess $1,384 
  
• Kogenate, Kovaltry, Jivi $974 
  
• Adalat $903
• Yaz, Yasmin, Yasminelle $875
  
• Adempas $873 
• Aspirin Cardio $802 
• Stivarga $564 
• Nexavar $515 
• Gadovist product family $494 
  
• Ultravist $422 
• Betaseron/Betaferon $398 
  
• Xofigo $308

1H 2022 sales

• Xarelto $2,603 
• Eylea $1,870 
• Mirena, Kyleena, Jaydess $711 
  
• Adalat $534 
• Kogenate, Kovaltry, Jivi $497
  
• Yaz, Yasmin, Yasminelle $485
  
• Aspirin Cardio $459 
• Adempas $373 
• Stivarga $354 
• Gadovist product family $279 
  
• Ultravist $257 
• Nubeqa $214 
• Nexavar $195 
• Betaseron/Betaferon $187 
  

Outcomes Creativity Index Score: 13

• Manny Awards — N/A
• Cannes Lions — 9
• Clio Health — N/A
• Creative Floor Awards — 4
• London International Awards – N/A
• MM+M Awards — N/A
• One Show — N/A

Chairman Werner Baumann

As Bayer continues to deal with the impact of Roundup litigation and other legal problems from the company’s acquisition of Monsanto, Chairman Werner Baumann may be encouraged to move on. 

Bloomberg reported in September 2022 that Bayer’s supervisory board had begun to search for a successor to Baumann, who had indicated that he would not be seeking for his contract to be renewed in 2024.

Baumann had told Bloomberg that despite the criticism over his strategy for the company’s diversified portfolio, he feels comfortable in his position as chairman. Baumann oversaw the $63 billion acquisition of Monsanto during 2018, which made Bayer the world’s largest agricultural company. But the acquisition also brought in a burden of litigation over Monsanto’s weed killer Roundup that Bayer is still struggling to deal with. And according to Bloomberg, investors are arguing that Bayer’s different divisions – Crop Science, Pharmaceuticals, and Consumer Health – would be more successful as individual companies.

This concern is not shared by Baumann or the supervisory board, as the company raised its guidance for the Crop Science and Consumer Health divisions, and the group as a whole, for 2022. Management expects the company to generate sales of €47 billion to €48 billion in 2022, up from about €46 billion, corresponding to an increase of about 8 percent (previously around 5 percent) on a currency- and portfolio-adjusted basis. 

“I enjoy what I’m doing,” Baumann told Bloomberg. “We have a strategy that you see in action that plays out very, very nicely. We have very, very strong operation results. We have just upgraded our guidance, so I’m a happy man.” 

To streamline the Crop Science Division and enhance future profitability, in March 2022 Bayer entered into a definitive agreement with Cinven to sell Bayer’s Environmental Science Professional business for $2.6 billion. 

“This divestment represents a very attractive purchase price and allows us to focus on our core agricultural business and the successful implementation of our Crop Science Division growth strategy,” stated Rodrigo Santos, member of the board of management of Bayer AG and president of the Crop Science division.

Environmental Science Professional is a global leader offering environmental solutions to control pests, diseases, and weeds in non-agricultural areas such as vector control, professional pest management, vegetation management, forestry, and turf and ornamentals. In 2021, the business had about 800 employees supporting operations and sales in more than 100 countries, with headquarters in Cary, N.C. Bayer had announced its decision to divest the business in February 2021.

“Driven by a shared belief in people and purpose, Cinven will enable the Environmental Science Professional business to advance towards its vision of healthy environments for everyone, everywhere,” Santos said. “We are convinced by Cinven’s focus and its commitment to the long-term growth potential for the business and its people.”

The transaction was expected to close in the second half of this year, with its net proceeds to be used to reduce Bayer’s net financial debt.

Managing roundup

Bayer won the company’s fifth consecutive case against claims that its herbicide Roundup causes cancer.

Bayer has prevailed in court against some of the lawsuits claiming that Roundup caused plaintiffs’ cancer. The company won its fifth consecutive lawsuit in September 2022 in St. Louis County, Mo.

All of the trials have focused on whether the chemical used in Roundup, glyphosate, causes cancer. The trial in St. Louis heard the claims of three plaintiffs in their 60s and 70s who accused Monsanto of withholding information about glyphosate causing cancer.

Bayer in May 2021 unveiled a five-point plan for the closure of U.S. glyphosate litigation, “which will allow our company, our customers, and our shareholders to move on, put the uncertainty behind us, and focus on our performance, innovations, and contributions to society.”

The company wants to see a positive ruling from the U.S. Supreme Court; continue to manage current cases; activate a claims plan to manage future cases; introduce new formulations of Roundup; and promote its new safety study webpage.

While the safety study webpage is up and running and Bayer is on track to replace glyphosate products in the U.S. residential lawn and garden market with new formulations that have alternative active ingredients beginning in 2023, getting a positive ruling from the Supreme Court has not occurred. 

In June 2022, the court chose not to hear Bayer’s cases, Monsanto Co. v. Edwin Hardeman and Monsanto Co. v. Alberta Pilliod and Alva Pilliod. In not accepting the cases, the court let previous judgments stand.

Bayer was ordered to pay the $87 million awarded in the Pilliod case and the $25 million awarded to Hardeman.

At the time the court rejected the Pilliod case, Bayer stated that it “respectfully disagrees” with the decision, but “There are likely to be future cases, including Roundup cases, that present the U.S. Supreme Court with preemption questions like Pilliod and Hardeman and could also create a Circuit split and potentially change the legal environment.”

Performance & Outlook

In talking about 2021 results, Baumann highlighted that it was a good year for Bayer. “When I look back at 2021, it was much more than just the year of transition that we announced at the beginning,” he stated. “Fiscal 2021 was a really good year for Bayer – both operationally and strategically. We posted substantial growth, strengthened our innovation pipeline and made progress toward our sustainability targets. All this shows that Bayer is on the right track!”

Touting its advancements in innovation, Baumann pointed out the launches of the kidney disease drug Kerendia; new Intacta 2 Xtend soybeans; and the Bepanthen Derma skin care product. 

“We invested a record €5.4 billion ($6.4 billion) in research and development in 2021,” he stated. “And we also further expanded our innovation capabilities with numerous acquisitions, investments and partnerships. Our Leaps by Bayer unit now holds stakes in more than 50 innovative biotech startups.”

The company generated total revenue of €44.08 billion ($52.15 billion) in 2021, 6.5 percent more than in the previous year. Net income was €1 billion ($1.18 billion) compared with a net loss of €10.5 billion ($12.42 billion) in 2020. Earnings per share were €1.02 ($1.21) compared with 2020’s loss per share of €10.68 ($12.63).

For the first half of 2022, sales were €27.46 billion ($32.48 billion), 18.4 percent more than in the first half of 2021. Net income was €2.99 billion ($3.54 billion) compared with a net loss of €246 million ($291 million) in the same period last year. Earnings per share for first-half 2022 were €3.05 ($3.61) compared with a loss per share of €0.25 (30 cents).

“We delivered strong operational performance,” Baumann says. “In terms of sales, we posted significant gains at Crop Science and strong growth at Consumer Health, as well as a slight increase at Pharmaceuticals, too. And with EBITDA before special items, we even achieved growth of 30 percent.”

Bayer’s Pharmaceuticals division generated sales of €18.35 billion ($21.71 billion) in 2021, 6.4 percent more than in 2020. Half-year 2022 sales for this division were €9.44 billion ($11.17 billion), 6.6 percent more than in first-half 2021.

The Crop Science division had 2021 sales of €20.21 billion ($23.90 billion), an increase of 7.3 percent versus the prior year’s total. In first-half 2022, sales reached €14.91 billion ($17.64 billion), 27.8 percent more than in the same period last year.

In announcing half-year results, Baumann stated that Bayer is not seeing any material financial impact in 2022 from any potential gas supply bottlenecks as a result of the war in Ukraine. The company has taken steps to ensure that the direct impact of any potential gas shortages on its own production capabilities this year is contained to the greatest degree possible, he explained. 

“From a technical perspective, we are well prepared to significantly reduce our reliance on natural gas by switching to alternative and renewable sources of energy,” Baumann says. “We have also launched programs to save energy and have built up our stocks of products where possible.” 

A higher degree of uncertainty stems from the company’s indirect exposure via its global supplier network, Baumann says. “That’s why we are expanding our network of suppliers and building up additional inventory of key raw materials and packaging materials.”

The Consumer Health division had 2021 sales of €5.29 billion ($6.25 billion), an increase of 4.7 percent. For the first half of this year, sales increased 18.3 percent from first-half 2021, to €3.01 billion ($3.56 billion).

In August 2022, Bayer’s Consumer Health leaders published a new paper, Science-Led Self-Care: Principles for Best Practice, that sets out five key principles that should underpin all self-care products improving personal health and wellness. The paper is intended to spark a conversation within the industry and its key stakeholders around the need to promote science-led self-care for the benefit of consumers.

Management stated that in the wake of the pandemic and the rise of accessible, digital information, consumers are becoming increasingly interested in maintaining and managing their own health. “Enabling this shift means consumers will need to have trust that the choices they make are the best,” they say. “The paper proposes that sound science is a core component to earning that trust.”

“We owe it to the consumer to help them navigate the self-care landscape and identify the products and services that are grounded in science and will help them to prevent disease and live healthy lives,” says Abbie Lennox, global chief regulatory, medical, safety, and compliance officer, Consumer Health division of Bayer. “Our five Principles of Science-Led Self-Care can be a blueprint for deeper discussion within our industry about how best we help consumers navigate a confusing landscape.”

Bayer’s five Principles of Science-Led Self-Care are:

• The Science of the Human – Self-care products rooted in a thorough understanding of human biology, medical insights and unmet needs.
• The Science of Regulation – Independent regulation, to ensure safety and efficacy through transparent communication, accurate labeling, and supported claims.
• The Science of Collaboration – Carefully judged collaborations focused on win-win outcomes can help to improve access to self-care, making products available more widely and empowering more consumers to take charge of their health.
• The Science of Discovery – Self-care products that have been rigorously researched, founded on scientific principles and developed with a deep understanding of consumers’ unmet needs.
• The Science of the Consumer-Product Experience — A seamless experience beginning with the initial search for information, continuing through to the physical interaction with the product itself that helps consumer better use self-care products.

Sales of Bayer’s top-selling product Xarelto pushed past $5.6 billion in 2021 and $2.6 billion during first-half 2022.

“We believe these principles will enable better self-care as we look to push the boundaries of how science and innovation can continue the amazing journey of people living better, healthier lives,” says David Evendon-Challis, chief scientific officer, Consumer Health division of Bayer. “We think these principles can also benefit others who are committed to this vision – greater consumer confidence will help boost the reputation of the self-care industry as a whole.”

Bayer’s top-selling pharmaceutical product is the blood thinner Xarelto, which generated €4.74 billion ($5.6 billion) during 2021, 4.9 percent more than in 2020. First-half 2022 sales were €2.2 billion ($2.6 billion), 4.4 percent less than in first-half 2021. Company executives say the decline was mainly due to tender procedures in China and the expiration of Bayer’s patent in Brazil.

Second in 2021 sales was the opthalmology drug Eylea at €2.92 billion ($3.45 billion), 18.2 percent more than in the previous year. Eylea’s sales were also strong in the first half of 2022 at €1.58 billion ($1.87 billion), 14.4 percent more than in the same period last year. Sales were strong in all regions, and especially in Europe due to the ongoing launch of Eylea prefilled syringes, executives say.

In the wake of the overturning of Roe v. Wade by the U.S. Supreme Court, Bayer received approval that extends the use of the IUD Mirena to eight years.

Bayer’s third-highest selling pharmaceutical product is the birth control family Mirena/Kyleena/Jaydess at €1.17 billion ($1.38 billion), an increase from 2020 of 8.2 percent. First-half 2022 sales of these products totaled €601 million ($711 million), a decline of 1.8 percent from first-half 2021.

No. 4 in 2021 sales was the hemophilia treatments Kogenate/Kovaltry/Jivi, at €828 million ($974 million), a decline of 3.3 percent. Sales went up 6.1 percent in the first half of 2022, to €420 million ($497 million).

Coming in fifth in sales was the cardiac drug Adalat at €763 million ($903 million, 24.5 percent more than in 2020. First-half 2022 sales were €451 million ($534 million), an increase of 29.2 percent compared with the first half of 2021. Sales were driven by demand in China.

Bayer’s sixth best-selling product line for 2021 consists of the birth control pills Yaz/Yasmin/Yasminelle, bringing in €740 million ($875 million), 10.4 percent more than in 2020. Sales in the first half of 2022 were €410 million ($485 million), 9 percent more than the same period last year.

The pulmonary hypertension treatment Adempas generated €738 million ($873 million) during 2021, 17.5 percent more than in 202o. Sales in the first half of 2022 continued to increase, particularly in the United States, with the global total amounting to €315 million ($373 million), 17.5 percent more than first-half 2021.

Bayer’s Aspirin Cardio, for the secondary prevention of heart attacks, totaled €678 million ($802 million) for 2021, 6.1 percent more than the previous year. Half-year 2022 sales were €388 million ($459 million), growth of 13.1 percent compared with the first six months of last year. Like Adalat, strong growth in China drove sales of Aspirin Cardio.

The cancer drug Stivarga posted €477 million ($564 million) in sales, up slightly versus the amount in 2020. Sales in the first six months of this year were €299 million ($354 million), 28.3 percent more than in first-half 2021. Bayer executives attributed the increase mainly to expanded volumes in China and the United States.

The cancer drug Nexavar posted sales of €435 million ($515 million), a decrease of 31.9 percent from 2020. This was especially noted in China, where the drug faced strong competition and modified tender procedures for various classes of active ingredients. Sales in the first half of 2022 continued to trend downward, at €165 million ($195 million), 28.6 percent less than in first-half 2021. 

The Gadovist family of radiology contrasts generated 2021 sales of €418 million ($494 million), 8.6 percent more than in 2020. Sales of the product family grew 15.7 percent in first-half 2022 to €236 million ($279 million).

The contrast Ultravist generated €357 million ($422 million), with growth of 17.8 percent over the 2020 total. Half-year 2022 sales were €217 million ($257 million), 27.6 percent more than in the same period last year.

Driven by competitive pressures – especially in the United States – sales of the multiple sclerosis drug Betaseron/Betaferon continued to decline in 2021, falling to €337 million ($398 million), 16.6 percent less than in 2020. The downward trend continued in the first six months of 2022, as the drug had sales of €158 million ($187 million), 6.5 percent less than in first-half 2021. 

 R&D Progress

Bayer continued to advance the company’s pipeline in 2021 and 2022.

In September 2022, the company announced a U.S. label update for the chronic kidney disease drug Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist, to include findings from the FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Bayer executives say FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage (1-2) CKD (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2) with albuminuria to show CV benefit in patients with CKD associated with T2D.

Results from the clinical trial have demonstrated that Kerendia provides dual cardiorenal risk reduction in adults with CKD associated with T2D. The drug received U.S. approval in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI), and hospitalization for heart failure in adult patients with CKD associated with T2D.

Management says with the addition of these study findings, the U.S. label now includes data from Kerendia’s comprehensive Phase III clinical trial program investigating kidney and CV outcomes in more than 13,000 patients with CKD associated with T2D.

“Our large body of clinical data demonstrates that Kerendia preserves kidney function and provides dual cardiorenal risk reduction in type 2 diabetes patients with a broad range of chronic kidney disease severity,” states Sameer Bansilal, M.D., M.S., FACC, VP, cardiovascular, U.S. medical affairs at Bayer. 

In another clinical trials results announcement in September, Bayer stated that the primary endpoint was met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) at week 48. Aflibercept is the active chemical in Eylea.

Sales of Eylea grew to $3.45 billion in 2021 and $1.87 billion in first-half 2022.

The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the non-inferiority of the two aflibercept 8 mg extended-
dosing regimens in terms of best corrected visual acuity (BCVA), compared to Eylea (aflibercept 2 mg) dosed every 8-week following initial monthly doses. In these trials, the safety of aflibercept 8 mg was consistent with the well-established safety profile of Eylea. Bayer will submit these data to regulatory authorities outside of the United States.

“These data mark a new era, as the extended dosing intervals of aflibercept 8 mg significantly reduced the treatment burden for a large majority of patients compared to the more intensive injection frequency currently required,” said Dr. Christian Rommel, member of the executive committee of Bayer’s Pharmaceutical Division and head of research and development. “All of this was accomplished while improving and maintaining vision with comparable safety to Eylea.”

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron Pharmaceuticals. While Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the United States, Bayer has licensed the exclusive marketing rights outside the United States, where the companies equally share the profits from Eylea’s sales.

Near the end of September 2022, Eylea was approved in Japan for the treatment of preterm infants with retinopathy of prematurity. The marketing clearance is based on the Phase III trial FIREFLEYE and data from the follow-up study FIREFLEYE NEXT. The medicine has been approved for six indications in Japan.

In August 2022, the company initiated a Phase III clinical development program, “OCEANIC,” to investigate the efficacy and safety of asundexian (BAY 2433334), an investigational oral Factor XIa (FXIa) inhibitor, in patients with atrial fibrillation (irregular heartbeat) and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (a stroke that lasts only a few minutes).

The initiation of the OCEANIC program is based on data from the PACIFIC Phase IIb clinical trial program, which consisted of one study in each of the following medical conditions: atrial fibrillation, a recent non-cardioembolic ischemic stroke, or a recent acute myocardial infarction (heart attack) for a total of three studies. Results from the PACIFIC-STROKE and PACIFIC-AMI studies were presented at the European Society of Cardiology Congress (ESC 2022) in Barcelona, Spain. Data from the PACIFIC-AF (atrial fibrillation) study were published in The Lancet and presented at the American College of Cardiology’s 71st Annual Scientific Session.

The OCEANIC Phase III clinical development program will start with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enroll up to 30,000 patients in more than 40 countries. 

OCEANIC-AF (Phase III program of the Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotic- Atrial Fibrillation study) will investigate asundexian compared to apixaban in patients with atrial fibrillation at risk for stroke. The primary objectives of OCEANIC-AF are to determine the effects on prevention of stroke and systemic embolism as well as compare the incidence of International Society on Thrombosis and Hemostatis (ISTH) major bleeding.

OCEANIC-STROKE (Phase III program of the Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC – STROKE study) will be a
placebo-controlled study on top of standard-of-care antiplatelet therapy. The primary objectives are to investigate asundexian for non-cardioembolic ischemic stroke or high-risk ischemic attack compared to placebo as well as compare the incidence of ISTH major bleeding.

“With deep experience and disease understanding, Bayer is particularly strong in the field of anticoagulation and has made significant contributions to the lives of patients. Focusing on Factor XIa inhibition, we are investigating a potential new class of antithrombotics,” Rommel said. “The underlying science of FXIa and Phase II PACIFIC data provide a foundation on which to advance asundexian forward into the OCEANIC Phase III program, one of the largest Phase III endeavors Bayer has undertaken.”

Also in August 2022, the FDA  approved a supplemental new drug application (sNDA) that extends the duration of use for Bayer’s IUD Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one more year, making it available to prevent pregnancy for up to eight years.

The approval is based on results from a Phase III extension trial evaluating the efficacy and safety of Mirena.

“Now more than ever, it’s important to help ensure that women have the options they need when it comes to contraception needs at various stages of their reproductive life,” stated Yesmean Wahdan, VP, U.S. medical affairs, Bayer Women’s Healthcare. “A large part of our ‘We’re For Her’ mission is helping to ensure education, access, and options. The investment in an eight-year indication will give women who are looking for birth control another option to discuss with their healthcare provider that may meet their needs and personal choice.”

Mirena, the first hormonal IUD to be approved for use in the United States in 2000, was previously approved to prevent pregnancy for up to seven years. Mirena also is the only FDA-
approved IUD to treat heavy periods for up to five years in women who choose intrauterine contraception and can be used in women if they have previously given birth or not. 

Also in August, the FDA approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on results of the Phase III ARASENS trial that demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint, with a reduction in the risk of death by 32 percent for those treated with Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel. Treatment with Nubeqa plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.

The ARASENS results were presented at the 2022 ASCO GU Cancers Symposium and simultaneously published in the New England Journal of Medicine. Nubeqa is also indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa is being investigated in further studies across various stages of prostate cancer.

“With compelling data from the Phase III ARASENS and ARAMIS trials, Nubeqa has demonstrated significant efficacy in mHSPC and nmCRPC,” says Christine Roth, member of the executive committee of Bayer’s Pharmaceutical Division and head of the Oncology strategic business unit at Bayer. “The expansion of Nubeqa’s indication to reach a broader population in the U.S. reaffirms Bayer’s commitment to provide proven and tolerable treatment options to eligible patients across different stages of prostate cancer.”

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