Headcount: 99,723
Revenues: $52,57  (-1%)
Pharma Revenues: $19,955 (flat)
Net Income: $4,383 (-20%)
R&D: $5,928 (-18%)

Sales in Bayer’s Pharmaceuticals business unit were $19.96 billion, which were flat compared to the year before when adjusted for currency. The Pharmaceuticals division’s most recent product launches achieved significant gains in 2023, with growth rates of 87% for the cancer drug Nubeqa and 152% for Kerendia for the treatment of chronic kidney disease associated with type 2 diabetes.

The division also posted continued sales growth for the ophthalmology drug Eylea, with an increase of 1%, as well as in the radiology business, which includes the Ultravist, CT Fluid Delivery and Gadovist product families. By contrast, sales of the cardiovascular drug Adalat decreased by 32%. In addition, sales of the oral anticoagulant Xarelto were also down, falling 10% as a result of competition and pricing pressure from generics.

In line with building up its Pharmaceuticals pipeline, Bayer entered several new alliances and collaborations in the past year. In June, Bayer announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics’ CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers. That month, Bayer also joined forces with Acuitas Therapeutics, a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas’ LNP technology will support Bayer’s in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the liver.

In October, Bayer entered an antibody discovery, option, and license agreement with Twist Bioscience Corporation, a company offering synthetic DNA using its silicon platform. In March, Bayer and Aignostics GmbH announced a strategic collaboration on several artificial intelligence (AI)-powered approaches with applications in precision oncology drug research and development.

In terms of investments, Bayer is spending $250 million in a new cell therapy manufacturing facility in Berkeley, CA, that will supply cell therapy products for additional clinical trials and future product launches. Furthermore, the company has inaugurated the “Bayer Co.Lab” incubator in Cambridge, MA, focused on cell and gene therapy startups with the aim of accelerating innovation and fostering collaborations within vibrant biotech ecosystems.

Headcount: 101,369
Pharma Revenues: $20.551 (+5%)
Net Income: $4,430 (+76%)
R&D: $3,626 (+8%)

Pharma sales for Bayer were $20.5 billion, up 4.9% for the year despite increasing inflation, rising interest rates, recessionary concerns and the effects of Russia’s war in Ukraine.  Over half a billion euros in sales came from the division’s new products: the cancer drug Nubeqa and Kerendia for the treatment of chronic kidney disease associated with type 2 diabetes. Sales of Nubeqa, for instance, almost doubled year on year. Strong growth was also recorded for the ophthalmology drug Eylea and in the radiology business, which includes the Gadovist and Ultravist product lines.

Bayer’s short- and mid-term growth will be further fueled by key products such as Eylea, Nubeqa, Verquvo and Kerendia, as well as late-stage R&D pipeline candidates, including elinzanetant and asundexian.

Building on its acquisitions of the U.S. companies BlueRock Therapeutics and Asklepios BioPharmaceutical, Bayer is further expanding its cell and gene therapy activities. By entering a partnership with U.S.-based Mammoth Biosciences, Bayer has secured access to novel gene-editing technology complementing its existing technology platforms. Last year’s acquisition of Vividion Therapeutics, also in the U.S., strengthens Bayer’s drug discovery capabilities. The company is also enhancing its technological capabilities through the targeted expansion of its digital R&D infrastructure. Moreover, Bayer is expanding its efforts to access external innovation through research collaborations and in-licensing, capturing continued growth opportunities in biologics and novel technologies.

In Oncology, Bayer continues to build its integrated Research & Early Development organization. With its new precision molecular oncology research center in Boston-Cambridge, Bayer will drive the development of novel targeted cancer therapies for people with unmet medical needs.

Bayer further expanded its development portfolio in the areas of cell and gene therapies. It currently contains seven projects at different stages of clinical development,

Bayer also made considerable progress in developing its late-stage pharmaceutical pipeline and its launches of promising medicines. In the case of Nubeqa, Bayer secured approval last year in the United States for an additional indication in patients with a specific type of prostate cancer. Furthermore, Kerendia was successfully launched in the U.S, Europe and Japan and obtained marketing authorization in China.

In October 2022, Vividion Therapeutics, a wholly owned subsidiary of Bayer, entered into a collaboration agreement with Tavros Therapeutics to discover or target four oncology targets across an initial 5-year term. The partnership aims to deliver multiple breakthrough discoveries for cancer patients in need.

Headcount: 99,673
Pharma Revenues: $20,803 (+6%)
EARNINGS: $1,132
R&D: $3,555 (+13)

TOP SELLING DRUGS

Pharma sales for Bayer were $20.8 billion, up 6.4% for the year as its business recovered from the impact of Covid-19 restrictions. The company is focused on prescription products, especially for cardiology and women’s healthcare, and on specialty therapeutics focused on the areas of oncology, hematology, ophthalmology, and cell and gene therapy.

Bayer’s near-term growth is driven by key products, such as Xarelto and Eylea, while its near- and mid-term growth will be further fueled by launch products, such as Nubeqa, Verquvo and Kerendia, and late-stage R&D pipeline candidates, such as elinzanetant.

Last year, Bayer’s Pharmaceutical division invested heavily in R&D in therapeutic areas with substantial need for innovation. Building on its acquisitions of the U.S. companies BlueRock Therapeutics LP, and Asklepios BioPharmaceutical, Inc. (AskBio), Bayer is further expanding its cell and gene therapy activities. The recent acquisition of Vividion Therapeutics, Inc., United States, strengthens Bayer’s drug discovery capabilities with a chemoproteomics platform. Vividion’s approach identifies previously unknown binding pockets in undruggable targets to generate novel compounds. Bayer is also enhancing its technological capabilities through the targeted expansion of its digital R&D infrastructure. Moreover, Bayer is expanding its efforts to access external innovation through research collaborations and inlicensing, capturing continued growth opportunities in biologics and novel technologies.

In September 2021, Bayer entered a collaboration with Huma Therapeutics. The joint research project is aimed at simplifying the analysis of computed tomography (CT) images with the help of machine learning. In October, Bayer’s U.S. partner Informed Data Systems Inc. (One Drop) introduced a One Drop module for cardiovascular disease prevention. The first product jointly developed with Bayer utilizes artificial intelligence to offer a personalized health program.  In January 2022, Bayer and Mammoth Biosciences inked an agreement for the use of Mammoth’s CRISPR systems to develop in vivo gene-editing therapies. Through Leaps by Bayer, an investment in Cellino Biotech aims to make stem cell-based regenerative medicines accessible for all eligible patients. Most recently, BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer, established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany.

Headquarters: Leverkusen, Germany
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www.bayerpharma.com

Headcount: 99,538
Pharma Revenues: $14,037 (-6%)
Loss: $12,881 (n/m)
R&D: $3,369 (+11)

TOP SELLING DRUGS

Pharma sales for Bayer were $14 billion, down 6% for the year. The company is focused on prescription products, for cardiology and women’s healthcare, as well as specialty therapeutics in the areas of oncology, hematology, ophthalmology and cell and gene therapy.

Bayer’s near- to medium-term growth is driven by key products such as Xarelto and Eylea, and will be further fueled by several promising late-stage R&D candidates, such as finerenone, and recently launched products, such as Verquvo and Nubeqa.
Last year, Bayer’s Pharmaceuticals Division invested heavily in external innovation, concluding more than 25 collaboration agreements and acquisitions. It took a major step forward in particular with the acquisition of Asklepios BioPharmaceutical (AskBio). This transaction, together with the acquisition of BlueRock Therapeutics in 2019, has put the company among the leading players in the promising and rapidly expanding area of cell and gene therapies.

Another fundamental element of the company’s new cell and gene therapy strategy is the partnership with Atara Biotherapeutics, which strengthens its cell therapy pipeline.

Bayer is also invested in external growth with the acquisition of KaNDy Therapeutics, which further expands its development portfolio in women’s healthcare. KaNDy’s recently completed Phase IIb for a non-hormonal oral compound, with positive data for the treatment of frequent symptoms of menopause.

Bayer also purchased an exclusive license from Systems Oncology for preclinical oral drug candidate ERSO, a treatment for women with metastatic estrogen receptor-positive breast cancer.

Through Leaps by Bayer, an investment in Metagenomi Technologies aims to find ways to cure genetic diseases through novel gene editing technologies. It also invested in Vesigen Therapeutics, with the goal of focusing modern cell and gene therapies on specific cells in the body, which is considered an especially critical supporting technology. Furthermore, the company has joined a financing round for Senti Biosciences, Inc., a U.S. biotech company which is a leader in the use of synthetic biology to engineer gene circuits to improve cell and gene therapy products.

In the area of immuno-oncology, Bayer invested in Triumvira Immunologics Inc., a company in the field of T-cell therapy. In microbiome research, it invested in Azitra Inc., with the aim of assembling a joint platform to develop novel antimicrobial dermatological products. Leaps by Bayer also invested in the foundation and incubation of early-stage biotech companies as part of the Israeli company FutuRx Ltd.

Most recently, amid sliding sales for prostate cancer drug Xofigo, Bayer bolstered its portfolio of targeted alpha therapies with the acquisition of radiotherapeutics biotech Noria Therapeutics and subsidiary PSMA Therapeutics. Bayer picked up exclusive rights to two investigational therapies in prostate cancer.

Headcount: 116,998
Pharma Revenues: $20,151 (+5%)
Net Income: $4,580 (+140%)
R&D: $3,082 (-5%)

TOP SELLING DRUGS

This past year, Bayer advanced several assets and submitted applications for a number of drug candidates and approval expansions for key products. The most notable of which are Nubeqa (darolutamide) in castration-resistant non-metastatic prostate cancer, and Xarelto (rivaroxaban) for Venous thromboembolism (VTE) treatment in children.

Offering significantly increased overall survival, Nubeqa was approved in the U.S. for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) based data from the Phase III ARAMIS trial demonstrating that Nubeqa, a nonsteroidal androgen receptor antagonist, in combination with androgen deprivation therapy, delays worsening of disease-related symptoms in men with nmCRPC. In January 2020, Nubeqa was approved in Japan for nmCRPC, followed by approval in the EU.

Bayer’s top seller Xarelto was approved by the FDA in October for the prevention of VTE in acutely ill patients at risk for thromboembolic complications who are not at high risk of bleeding. Further, findings from the Phase III EINSTEIN-Jr. trial showed efficacy and safety of Xarelto in children with venous thromboembolism, similar to those seen in previous studies in adults. In November, Bayer submitted an application to the European Medicines Agency (EMA) seeking approval.

Also notable, in September, the European Society of Cardiology (ESC) recommended that Xarelto vascular dose plus aspirin low dose should be considered in the treatment of patients with chronic coronary syndromes at high risk of further events. Another ESC guideline recommends this regimen in patients with diabetes and lower extremity arterial disease.

In oncology, several candidates are advancing. Bayer was granted Breakthrough Therapy designation for Aliqopa (copanlisib) for the treatment of patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is a form of indolent non-Hodgkin lymphoma (iNHL).

Also, precision oncology therapy Vitrakvi (larotrectinib) achieved a high level of efficacy in both adults and children with tropomyosin receptor kinase (TRK) fusion cancer and brain metastases–primary tumors of the central nervous system. In addition, clinical data showed a high response rate even with an expanded dataset, while median overall survival was more than three years.
In November, the Phase III study VICTORIA evaluating the use of vericiguat in patients with chronic heart failure with reduced ejection fraction (HFrEF) met its primary endpoint, reducing the risk of cardiovascular death or heart failure hospitalization versus placebo, when given in combination with available heart failure therapies. Vericiguat, a first-in- class soluble guanylate cyclase (sGC) stimulator, is designed to boost a cell signaling pathway that helps relax blood vessels and increase blood flow. It’s being jointly developed with Merck in the U.S. and Canada to treat patients with worsening chronic heart failure.

Other key approvals include Vitrakvi and Gadavist. Vitrakvi received tumor-agnostic approval in the EU for the treatment of solid tumors that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion with locally advanced, metastatic disease, or where surgery is likely to result in severe morbidity, and where no satisfactory treatment options exist.
Lastly, Gadavist was approved by the FDA as the first and only contrast agent for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD).

Discontinued Assets
In September, the company discontinued the development program for its anti-TFPI antibody BAY 1093884 for the treatment of hemophilia for safety reasons after a Phase II trial investigating the safety and tolerability of BAY in hemophilia A or B with or without inhibitors was halted.

Shortly thereafter, development of its TASK channel blocker BAY 2253651 was discontinued after it failed to demonstrate sufficient efficacy in a Phase II trial in the treatment of obstructive sleep apnea.

Also, earlier this year Bayer stopped development of fadaltran, an alpha2c AR antagonist after failing to meet efficacy endpoints in a Phase IIa trial.

Alliances
Several oncology alliances aim to advance Stivarga and Vitrakvi. A clinical collaboration with Bristol-Myers Squibb and Ono Pharmaceutical Co., will test the combination of Bayer’s multikinase inhibitor Stivarga (regorafenib) and BMS / Ono’s immuno-oncology treatment Opdivo (nivolumab) in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC), the most common form of mCRC.

Following the acquisition of Loxo Oncology by Lilly in February, Bayer exercised a change of control clause in its licensing agreements with Loxo Oncology. As a result, Bayer now has exclusive licensing rights for the global development and commercialization of Vitrakvi (larotrectinib), including the U.S., and the investigational drug selitrectinib (BAY 2731954, formerly: LOXO-195). Bayer is also working with Foundation Medicine Inc. for the development of companion diagnostics based on its next-generation sequencing for new cancer drugs. The first project will be to develop a CDx test in the U.S. for Vitrakvi.

Also, a collaboration with Arvinas, Inc. aims to develop next-generation medicines for cardiovascular, oncological and gynecological diseases. The four-year agreement includes an upfront payment and R&D support, as well as a direct equity investment.

Further, an agreement with Exscientia Ltd. will explore early research projects to treat cardiovascular and oncological diseases leveraging Exscientia’s AI-driven drug discovery and design. Under the agreement, which is initially set to run for three years, the companies aim to identify and optimize novel lead structures for potential drug candidates.

Additional alliances focus on cardiovascular and women’s health. In November, Bayer entered into an option, research and license agreement with Dewpoint Therapeutics, leveraging Dewpoint’s platform for biomolecular condensates and Bayer’s small molecule compound library to develop new treatments for cardiovascular and gynecological diseases.

Also, an expanded partnership with Evotec SE in women’s health includes a new five-year, multi-target collaboration to develop multiple clinical candidates for the treatment of polycystic ovary syndrome (PCOS). PCOS is the most frequent endocrine disorder in women linked to metabolic dysfunction and the most frequent cause of female infertility.

Finally, Bayer entered an exclusive license agreement with Daré Bioscience for Ovaprene, a hormone-free, intravaginal ring that is currently in clinical development for pregnancy prevention. If approved, it could be the first monthly non-hormonal contraceptive product.

Headcount: 116,998
Revenues: $45,278  (+13%)
Pharma Revenues: $19,154 (-1%)
Net Income: $1,934 (-77%)
R&D: $6,000  (+16%)

TOP SELLING DRUGS   

After Bayer made the mega $63 billion deal for Monsanto, turning it into the world’s largest agro-chemical maker and seed producer, it was forced to make some major overhauls.

The company announced at the end of the year it would be axing 12,000 jobs throughout the crop science, pharma and consumer units. Of the job losses, roughly 1,250 were in pharma with 350 related directly to a new manufacturing facility in Wuppertal, Germany that the company will not use, focusing all recombinant factor VIII production at its Berkeley, CA site instead.

In addition, as this issue went to press Bayer had already sold off the iconic Coppertone skin care brand and was still looking for a buyer for the Dr. Scholl’s foot care brand and its animal health unit. China’s Fosun International, parent of Fosun Pharma, was on the hunt for the animal health business, looking to partner with private equity to make an offer—the sale could be worth nearly $8 billion if it goes down.

With all the shake-ups, pharma sales were off by just one percent for the year ($19.2 bn) when factoring in exchange rates. Growth in pharma is being driven primarily driven by its top selling drug Xarelto and Eylea, with several promising late-stage R&D pipeline candidates. Sales of the oral anticoagulant Xarelto were up 17% and eye medicine Eylea climbed 21% while cancer drugs Stivarga and Xofigo, and the pulmonary hypertension treatment Adempas advanced by 13.5%.

Looking ahead to the eventual loss of exclusivity for Xarelto and Eylea, Bayer is amping up its oncology pipeline. At the end of 2017 it made a deal with Loxo Oncology to develop and commercialize larotrectinib and LOXO-195, Loxo Oncology’s franchise of highly selective TRK inhibitors for patients with TRK fusion cancers. A year later, in November 2018, FDA approved larotrectinib, which is now sold under the brand name Vitrakvi.

More good news came on the cancer treatment front when Bayer reported positive results of the Phase III study of darolutamide, a novel androgen receptor antagonist of for the oral treatment of prostate cancer that is being developed jointly by Bayer and the Finnish biopharmaceutical company Orion Corporation.

Research and development of new immunotherapy approaches in oncology continued through a partnership with Compugen Ltd., a company focused on predictive discovery and development of therapeutics for cancer immunotherapy. COM902, its lead anti-TIGIT antibody, advanced into manufacturing for an investigational new drug (IND) application that was anticipated in 2019. The companies entered into a process development and manufacturing service agreement to produce COM902 for future use in clinical trials.

With the University of Texas MD Anderson Cancer Center it signed a five-year collaboration agreement to accelerate the development of novel targeted treatments based on patient or tumor characteristics for which current therapies have not shown satisfactory clinical efficacy. Bayer will contribute early stage as well as clinical assets from its development pipeline for further clinical development at MD Anderson Cancer Center. The MD Anderson Cancer Center will bring in its translational and clinical expertise to help accelerate ongoing and future clinical trials.

Beyond cancer
Bayer entered a few collaborations during the year outside the cancer realm. With the Broad Institute of MIT and Harvard, Bayer launched the joint Precision Cardiology Laboratory, which will pursue novel scientific insights to enable the development of new therapies for patients with cardiovascular diseases such as heart failure. Heart failure—a general diagnosis given when the heart doesn’t pump effectively—is a composite of multiple factors, and as such requires new tools and methods to gain deeper knowledge to benefit patients. The scientists at the joint laboratory will combine Broad Institute’s methods for basic science discovery such as single cell sequencing and clinical expertise with Bayer’s long experience in drug development to discover new potential therapeutics.

Furthermore, Bayer and Haplogen GmbH, a Vienna-based biotechnology company, entered into a multi-year research collaboration agreement to identify new drug candidates for the treatment of pulmonary diseases such as chronic obstructive pulmonary disease (COPD). COPD is a common and heterogeneous respiratory disease that causes breathlessness and predisposes to exacerbations and serious illness. Respiratory viral infections are one frequent cause of COPD exacerbations. One possible treatment approach for COPD exacerbations is to disrupt the multiplication of the responsible virus by inhibiting its replication. The goal of the research alliance is to develop new antiviral compounds addressing the high unmet medical need in reducing COPD exacerbations.

At the start of 2019, Bayer and Kyoto University agreed on a strategic research alliance to jointly identify new drug targets for the treatment of pulmonary diseases such as idiopathic pulmonary fibrosis. The goal of the research alliance is to identify specific targets and pathways that are causing the disease and to discover new treatments to modulate these pathways and prevent further lung functions decline. Bayer has an option for the exclusive use of the collaboration results.

Headcount: 99,820
Revenues: $41,943 (+3%)
Pharma Revenues: $20,180 (+3%)
Net Income: $9,696 (+68%)
R&D: $5,395 (+2%)

TOP SELLING DRUGS   

Maintaining its position, Bayer’s Pharmaceutical segment saw modest growth in 2017, as pricing pressure, generic competition and health care reforms led to lower growth across all regions. Key growth products Xarelto, Eylea, Stivarga, Xofigo and Adempas performed well with combined sales up 16%. Bayer’s flagship oral anticoagulant Xarelto continued to develop successfully with new indications approved and sales growth in Europe, Japan and China. Bayer also posted further gains for its license revenues – recognized as sales in the U.S. – where Xarelto is marketed by a subsidiary of Johnson & Johnson.

Bayer’s second highest seller, eye drug Eylea grew 16% attributed to expanded volumes in Europe, Canada and Japan.

Xofigo sales were up 23% to $489 million due mainly to its market launch in Japan in 2016 and higher demand in the U.S. Also, sales of cancer drug Stivarga were up 15% to $377 million, benefiting from new approvals in 2017 as a second-line treatment for patients with hepatocellular carcinoma, and pulmonary hypertension treatment Adempas saw $353 million in sales, up 16% mainly as a result of sales growth in the U.S.

Offsetting some of this growth, Kogenate sales suffered due to lower order volumes being placed for the active ingredient by a distribution partner ahead of the planned contract termination at the end of the year. Also, sales of multiple sclerosis drug Betaferon continued to fall primarily as a result of a highly competitive market.

R&D Efforts

Bayer’s Pharmaceutical segment focuses on products for cardiology and women’s healthcare, specialty oncology, hematology and ophthalmology, as well as diagnostic imaging and contrast agents, and in 2017, Bayer managed to transfer ten new molecular entities from its research pipeline into preclinical development.

Bayer picked up several key approvals this past year. In August, the European Commission (EC) expanded the prescribing information for Xarelto to include patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention with stent placement and require oral anticoagulation.

Also, the company’s oral multikinase inhibitor Stivarga picked up an additional indication to treat patients with hepatocellular carcinoma (HCC) who had previously been treated with Nexavar. Stivarga is the first medicine to show a significant improvement in overall survival in second-line treatment of patients with HCC for whom there was previously no further treatment option. The product had been approved for second-line treatment of HCC in the U.S. in April 2017 and in Japan in June 2017.

Additionally, the FDA approved copanlisib under the brand name Aliqopa for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior therapies. Accelerated approval was granted for this indication based on overall response rate. Copanlisib is the only approved PI3K inhibitor with inhibitory activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It’s also the only one to be administered intravenously on an intermittent schedule. In the trial, copanlisib achieved an impressive overall response rate of 59%, with 14% of patients achieving a complete response, and a median duration of response of 12.2 months.

Late Stage Hits & Misses

Bayer has several late-stage assets moving through the pipeline, with some trials ongoing, and others that have been terminated. Bayer and development partner Janssen R&D ended the Phase III NAVIGATE ESUS trial of Xarelto for the secondary prevention of strokes and systemic embolisms in patients who had recently suffered an embolic stroke of unknown origin. Following interim analysis, an independent Data Monitoring Committee recommended that the trial be terminated early since the efficacy of rivaroxaban compared with acetylsalicylic acid (ASA) was similar in the treatment groups and offered limited potential for clinical benefit.

Also, the global Phase III program INHALE, which investigated Amikacin Inhale in intubated and mechanically ventilated patients with Gram-negative pneumonia in addition to standard treatment, did not demonstrate any clinical superiority versus the standard treatment. Neither the primary endpoint nor the secondary endpoints were achieved, and as a result, Bayer terminated its Amikacin Inhale research collaboration with Nektar Therapeutics.

Moreover, following the recommendation of an independent data monitoring committee, Bayer unblinded ahead of schedule a Phase III trial of radium-223 dichloride in combination with abiraterone acetate and prednisone / prednisolone in patients with metastatic castration-resistant prostate cancer, following the observance of an imbalance in terms of more fractures and deaths in the treatment arm.

Moving forward, following positive Phase II data, Bayer launched a Phase III study investigating molidustat in patients with renal anemia. Molidustat is an inhibitor of the enzyme hypoxia-inducible factor-prolyl hydroxylase that stimulates the production of erythropoietin and the formation of red blood cells.

Also, the ASTEROID Phase III program is underway investigating vilaprisan in women with symptomatic uterine fibroids. Vilaprisan is a novel orally dosed, selective progesterone receptor modulator developed by Bayer for enabling long-term treatment of uterine fibroids.

Lastly, a study program is currently investigating the efficacy and safety of rivaroxaban for the treatment and secondary prevention of venous thromboembolism in children. Should this program see successful completion, Bayer would gain extended patent protection for Xarelto in Europe and the U.S. by a further six months.

Early Research Alliances

Several early research alliances aim to uncover new pathways in kidney diseases and oncology. A five-year strategic research alliance with Vanderbilt University Medical Center in Nashville aims to develop new compounds for treating kidney diseases. The goal is to rapidly transfer innovative approaches from the lab to preclinical development.

Additionally, Bayer and PeptiDream Inc., a Japanese biopharmaceutical company, entered a drug discovery agreement covering various therapeutic areas such as oncology and cardiology, as well as classes of drug targets. Using PeptiDream’s Peptide Discovery Platform System technology, the partners will work to identify novel drug discovery candidates for target structures that are difficult to address.

Also, an exclusive alliance with Loxo Oncology aims to develop and commercialize larotrectinib (LOXO-101) and LOXO-195 for the treatment of cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

In recent news, Bayer and the University of Texas MD Anderson Cancer Center signed a five-year collaboration aimed at accelerating the development of new targeted treatments based on patient or tumor characteristics for which current therapies have not shown clinical efficacy. Bayer will contribute early stage as well as clinical assets from its development pipeline for further clinical development at MD Anderson Cancer Center. MD Anderson will apply its translational and clinical expertise to help accelerate ongoing and future clinical trials.

Headcount: 115,200
Revenues: $49,274 (-3%)
Pharma Revenues: $17,300 (+15%)
Net Income: $4,330 (-4%)
R&D: $2,936(+15%)

TOP SELLING DRUGS

Leverkusen, Germany-based Bayer rounds out this year’s top 15, jumping up four spots from number 19 on $17.3 billion in revenues, which grew from $15 billion in 2015. The Pharmaceuticals segment focuses on cardiology and women’s healthcare, and on specialty therapeutics in the areas of oncology, hematology and ophthalmology.

Pharmaceuticals performed well driven by key growth products, including the cardiovascular drug Xarelto, and Eylea, for macular degeneration. Xarelto sales jumped 25% to $3 billion, due to expanded volumes in Europe and Japan, while Eylea also made substantial gains, seeing its sales rise 28% to $1.7 billion.

Phase III and beyond

In May 2016, a Phase III study investigating regorafenib (Stivarga) in unresectable liver cancer reached its primary endpoint, a statistically significant improvement of overall survival. The study investigated regorafenib in patients with hepatocellular carcinoma whose disease had further progressed during prior treatment with sorafenib (Nexavar). Based on these data, it submitted regorafenib for marketing authorization for the treatment of unresectable liver cancer in Europe, Japan and the U.S. in 3Q16.

In June 2016, Bayer agreed with Orion Corp. to expand the global clinical development program for the androgen receptor (AR) antagonist BAY-1841788 (ODM-201). A new Phase III study is evaluating BAY-1841788 in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who are starting first-line hormone therapy.

Also in June, Bayer formed a new research partnership with the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) for a Phase III study that will investigate regorafenib as a single agent for adjuvant treatment following completion of standard adjuvant chemotherapy in patients with advanced but not yet metastatic colon cancer.

In September 2016, a Phase III trial was initiated to evaluate vericiguat, a soluble guanylate cyclase (sGC) stimulator, in patients suffering from chronic heart failure with reduced ejection fraction. The development and commercialization of vericiguat are part of the worldwide strategic collaboration between Bayer and Merck & Co. in the field of sGC modulation.

In terms of filings and approvals during the year, in February 2016, Bayer received approval from the European Commission for Kovaltry for the treatment of hemophilia A in patients of all age groups. Kovaltry is an unmodified recombinant factor VIII product that in clinical trials has demonstrated efficacy and tolerability as an on-demand therapy and for prophylactic use two or three times per week by hemophilia A patients. In March 2016, Kovaltry was approved by the FDA and the Japanese Ministry of Health, Labour and Welfare (MHLW).

Also in March 2016, the Japanese MHLW granted marketing authorization for Xofigo for the treatment of adult patients with castration-resistant prostate cancer and bone metastases.

In May 2016, the FDA approved Gadavist/Gadovist (gadobutrol) as the first contrast agent for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in patients of all ages.

Additionally, the FDA approved Bayer’s new low-dose levonorgestrel-releasing intrauterine system with the brand name Kyleena. The new system releases the lowest daily hormone dose in an intrauterine system for up to five years of protection against pregnancy. Bayer also completed the corresponding decentralized registration procedure for the EU. On this basis, it is expected that the health authorities of the EU member states will grant national marketing authorizations in the coming months.

In November 2016, an expansion of indications was filed for Stivarga (regorafenib) in the U.S., Japan and Europe. The filings pertain to the second-line treatment of patients with unresectable hepatocellular carcinoma. The FDA granted priority review status to regorafenib in the registration process for the expansion of indications. The Japanese Ministry of Health, Labour and Welfare (MHLW) granted priority review status for the registration filing in January 2017.

Partnerships

During the year, Bayer entered several partnerships to advance its drug development initiatives. Bayer and Evotec entered into a five-year, multi-target research partnership to develop multiple clinical candidates for the treatment of kidney diseases such as chronic kidney disease in diabetes patients. Both companies will contribute drug targets and a comprehensive set of high-quality technology platforms to jointly develop innovative treatment options for these severe conditions. The partners will share responsibilities during preclinical development of potential candidates.

Bayer receives exclusive access to selected candidates as well as to Evotec’s CureNephron target pipeline. Bayer will be responsible for any subsequent clinical development and commercialization. Evotec will receive a minimum of €14 million over the contract period including research payments and an undisclosed license fee. In addition, Evotec is eligible to receive preclinical, clinical and sales milestones of potentially over €300 million.

Back in 2012, Bayer and Evotec entered into a five-year partnership in the therapeutic area of endometriosis. Currently in its fourth year, this alliance has delivered four preclinical candidates and one first-in-class clinical program has been initiated.

Bayer and X-Chem entered an expanded global drug discovery collaboration across multiple therapeutic areas and target classes. Bayer has expanded access to X-Chem’s DEX technology, which is based on DNA-encoded libraries of small molecules with more than 120 billion molecules. The collaboration aims to discover lead structures for complex drug targets in areas of high unmet medical need. X-Chem received an upfront payment, research and development funding, as well as development milestones totaling as much as $528 million. Bayer has an exclusive option to license any programs under the collaboration. X-Chem will also receive royalties and sales milestones. The companies have been working together since 2012 and Bayer has licensed two programs of small molecules from X-Chem that address complex target structures such as protein:protein interactions. The new multi-year collaboration expands the scope and duration of the partnership.

Regeneron Pharmaceuticals and Bayer will jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody nesvacumab and the vascular endothelial growth factor (VEGF) trap aflibercept, for the treatment of serious eye diseases. Two separate Phase II studies are evaluating the combination therapy as a co-formulated single intravitreal injection in patients with wet age-related macular degeneration or diabetic macular edema.

Preclinical data demonstrates that angiopoietins act together with the VEGF family to promote the formation and maturation of blood and lymphatic vessels in the eye. Ang2 and VEGF together therefore have the potential to influence the pathological development of new blood vessels and the permeability of blood vessel walls in certain diseases of the eye.

Regeneron and Bayer currently collaborate on the global development and commercialization of Eylea (aflibercept) Injection and on the global development of REGN2176-3, the Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) antibody rinucumab co-formulated in a single intravitreal injection with aflibercept, which is currently in Phase II trials in patients with wet age-related macular degeneration.

With the Broad Institute it formed a strategic partnership in the field of genome and drug research in cardiology aimed at using findings from human genetics to develop new cardiovascular therapies, and in the field of oncology, to identify and develop active ingredients that target tumor-specific gene alterations.

Also, with the German Cancer Research Center it formed a partnership for the development of new therapeutic options in oncology, especially in immunotherapy. It teamed up with ImmunoGen in the field of antibody-drug conjugates (ADCs) for novel tumor therapies. With Janssen Research & Development, Bayer is furthering development of Xarelto (rivaroxaban), and with MorphoSys AG, partnered on antibody-drug conjugates using MorphoSys’s HuCAL technology.

Headcount: 111,800
Revenues: $50,611 (+12%)
Pharma Revenues: $15,017 (+13%)
Net Income: $4,490 (+20%)
R&D: $2,549 (+12%)

TOP SELLING DRUGS 

Sales of Bayer’s pharmaceuticals segment climbed nearly 10 percent in 2015 driven by five recently launched products—Xarelto, Eylea, Stivarga, Xofigo and Adempas.

At the end of the year, the company established its new Bayer Life Science Center. This strategic innovation unit has been designed to help uncover, encourage and unlock breakthrough cross-species technologies and know-how for Bayer by enabling collaborations with entrepreneurial best-in-class companies. The first of these partnerships is a joint venture with Crispr Therapeutics AG, a company specialized in utilizing the new crispr-cas9 gene editing technology.

The partnership will focus on the discovery, development and commercialization of therapeutics for blood disorders, blindness and congenital heart disease. Crispr Therapeutics will contribute its crispr-cas9 gene-editing technology and intellectual property, while Bayer will provide protein engineering expertise and relevant disease knowledge.

The joint venture will be based in London, UK, with operations in Cambridge, MA. This long-term strategic partnership represents the first of its kind investment in the development of target delivery systems in an effort to bring systemic in vivo crispr-cas9 gene editing technology applications to patients.

This is the first investment by the newly established Bayer LifeScience Center, which operates as a strategic innovation unit within Bayer aimed at discovering scientific and medical breakthroughs more rapidly by enabling innovative partnerships. Bayer will provide a minimum of $300 million in R&D investments during the next five years and will acquire a minority stake in Crispr Therapeutics for $35 million.

During the year Bayer and The Johns Hopkins University entered into a five-year collaboration agreement to develop new ophthalmic therapies targeting retinal diseases. The partners will jointly work on the discovery and development of innovative drugs for the treatment of serious back-of-the-eye diseases that affect many people worldwide, including age-related macular degeneration (AMD), diabetic macular edema (DME), geographic atrophy, Stargardt’s disease, and retinal vein occlusion (RVO).

Bayer also licensed a thrombosis drug from Ionis and as part of the deal will assume clinical development and commercialization of it as well. The deal relates to Isis-FXIRx, an antisense investigational drug in development for the prevention of thrombosis. Bayer will further develop and commercialize Isis-FXIRx in areas of high unmet medical need.

Bayer HealthCare and Aronora entered a strategic alliance to manufacture Aronora’s AB-022 compound for the treatment of cardiovascular diseases.

In other news, Bayer unveiled plans to invest $100 million in its Berkeley, CA manufacturing site to build a product testing facility that will support the next generation of treatments for hemophilia A.

Headcount: 60,700
Revenues: $51,341 (+5%)
Pharma Revenues: $14,649 (-5%)
Net Income: $2,982 (-13%)
R&D: $2,283 (+1%)

TOP SELLING DRUGS   

The big news during the year for the number one German pharma company was its purchase of Merck’s OTC business for $14.2 billion. Bayer recorded a 5% percent drop in revenue in 2014 with $14.6 billion, and maybe this deal will help swing sales in a positive direction. Included in the deal are the global trademark and prescription rights for Claritin and Afrin.

The companies also entered a clinical development collaboration to market and develop a portfolio of soluble guanylate cyclase (sGC) modulators, including Bayer’s Adempas (riociguat), which is approved to treat pulmonary arterial hypertension (PAH) and patients with chronic thromboembolic pulmonary hypertension (CTEPH). Adempas is currently marketed in the U.S., Europe and Japan. The companies will share costs and profits from the collaboration and implement a joint development and commercialization strategy.

The collaboration also includes development of vericiguat (BAY102), which is currently in Phase II trials for worsening heart failure, as well as opt-in rights for other early-stage sGC compounds in development at Bayer. In turn, Merck will make available its early-stage sGC compounds under similar terms.

Bayer also entered a global partnership with Orion Corp. for the development and commercialization of ODM-201, an investigational oral androgen receptor inhibitor entering Phase III development for the treatment of prostate cancer. The companies will jointly develop ODM-201, with Bayer covering the majority of development costs and responsibility for global commercialization.

Headcount: 56,000
Pharma Revenues: $15,32 (69%)
Total Revenues: $25,92 (32%)
Net Income: $15,32 (64%)
R&D Budget: $2,26 (56%)

TOP SELLING DRUGS 

The pharma arm of a large, diversified chemical and technology company in Germany, Bayer’s pharmaceutical business is divided into pharmaceutical and consumer healthcare divisions.

Recently, the company extended its reach in the consumer healthcare business by acquiring Merck and Company’s consumer healthcare business assets for $14.2 billion, which include such household names as Claritin. It stands to become the world’s second largest consumer healthcare company.

Last year, the company saw its pharmaceuticals business grow by 3%, driven mainly by emerging market growth, consumer healthcare by 4%, and animal health by 4%.

In its name brand pharma business, Bayer is focusing on oncology, hematology and ophthalmology therapies, as well as on hormonal therapies and contraceptives.  The company relies on a network of research partnerships to drive innovation, and also explores synergies between biopharmaceutical research projects involving its human, animal and plant health divisions.  Healthcare and crop sciences, for instance, are studying energy metabolism and gene regulation.

The company’s pharmaceuticals division has launched five products recently:
• Xarelto (rivaroxaban), an anti-coagulant that is being developed in a license with Janssen
• Stivarga (regorafenib), an oral multikinase inhibitor treatment for colorectal and gastrointestinal cancers, copromoted by Bayer and Amgen’s Onyx Pharmaceuticals, which provides a foothold in the orphan drugs market.
• Xofigo, a treatment for bone metastases in prostate cancer, based o radium 223 dichloride, jointly developed with Algeta SAS of Norway
• Eyelea (aflibercept), jointly developed with Regeneron, a treatment for various eye diseases that blocks natural growth factor (vascular endothelial growth factor (VEGF), preventing abnormal formation of new blood vessels.  It was developed for the treatment of wet age-related macular degeneration and edema
• Riociquat, a treatment for pulmonary hypertension that has been approved in the U.S. and Japan.  It is the first member of a new class of vasodilating agents

In other areas, the company is working on cancer stem cell research (rather than stem cell research in general) with OncoMed Pharmaceuticals. It is collaborating on BiTe antibodies with Amgen, mitogen-activated ERK kinase inhibitors with Arden Biosciences, and with the BioInvest International on antibodies, and Broad Institute on oncology gene mutation.

Bayer also has joint research projects in place with Peking and Tsinghua universities in China, and has been involved with Oxford University in the U.K. in R&D involving women’s health. The company is working with Prometheus Labs and Qiagen on diagnostics tools that would be used for personalized medicine therapies.

In antibody drug conjugates (ADCs) for the oncology market, Bayer is currently licensing technology from Seattle Genetics. It is also working with Dimension Therapeutics on new gene therapies, and with Nektar and Novartis on antibiotic
inhalation therapies.

The company set up a CoLaborator incubator in San Francisco two years ago, to fund interesting new product ideas and now plans to establish a second one in Berlin. Bayer also addresses biotech research via its Bayer Technology Services division.

Headcount: 110,500
Pharma Revenues: $13,8900%
Total Revenues: $51,12 (31%)
Net Income: $3,145 (-9%_
R&D Budget: $2,014 (-7%)

Top Selling Drugs

Account for 64% of total pharma sales, down from 65% in 2011

Last year, we noted that Bayer is pushing to hit a goal of 26% overall growth in pharma revenues between 2011 and 2014, from €9.9 billion to €11.5, so 2012’s 9% sales growth (in Euros) makes a very good start. In fact, the company was so happy that it made a 2015 target of €13.0 billion in pharma revenues!

Bayer more than offset generic losses to Yasmin with strong performance from other established products. In 1Q13, Bayer saw an additional €200 million in revenues from new products like Xarelto, Eylea and Stivarga, and expects solid results from newly approved prostate cancer treatment Xofigo. Bayer hopes to add first-in-class pulmonary hypertension treatment Riociguat to that stable of new products. All told, the company expects those five drugs to generate total sales of €5.5 billion at peak, albeit including partners’ shares.

As part of that goal, Bayer and partner J&J are trying to get Xarelto’s label expanded, but failed to get approval for prevention of heart attacks and strokes in patients with serious chest pain or history of cardiac illness. FDA approved it for treatment of deep vein thrombosis and pulmonary embolism in November 2012. Bayer will need all five new and pending drugs to perform, as multiple sclerosis treatment Betaferon declines against the pressure of next-generation MS drugs. The company has some lofty performance goals ahead, but some wise partnering efforts have put it in a position to succeed.

Acquisition News
Target: Steigerwald Arzneimittelwerk
Price: not disclosed
Announced: May 2013
What they said: “This acquisition broadens our product offering for the treatment of gastrointestinal disorders and gives us the opportunity to enhance our presence in Germany, the fast-growing regions of East-Central Europe, and the CIS countries.”

—Dr. Marijn Dekkers, chief executive officer, Bayer AG

Target: Conceptus
Price: $1.1 billion
Announced: April 2013
What they said: “Our experience in the field of gynecology combined with our sales and distribution expertise will help to further develop Conceptus’ business.”

—Andreas Fibig, president, Bayer HealthCare Pharmaceuticals

Target: Teva Animal Health (U.S.)
Price: $60 million, plus $85 million in milestones
Announced: September 2012
What they said: “Teva’s animal health business is a great strategic fit that allows us to strengthen and broaden our range of animal care solutions for our customers.”

—Dr. Joerg Reinhardt, chief executive officer, Bayer HealthCare

Headcount: 111,400
Pharma Revenues: $14,485 (-1%/+4%*)
Total Revenues: $46,593 (7%/+13%*)
Net Income: $1,728 (-9%/-4%*)
R&D Budget: $2,325 (6%/+11%*)

* Converted at avg. exch. rate / based on reported currency (EUR)

Top-Selling Drugs in 2010

Account for 56% of total pharma sales, down from 57% in 2009.

PROFILE

Bayer had a rough 2010, following what it called a “crisis year” of 2009. Yasmin lost patent protection in the U.S. in June 2010, leading to a 17% revenue drop for the year, while top seller Betaferon slipped 5% (flat in Euros) due to competition.  Times are so tough, the company decided to change the name of its pharma unit; “Bayer Schering” has become “Bayer Healthcare,” as part of a January 2001 streamlining. (Also, the company stopped giving info for its diagnostic imaging business, so those revenues are now counted as part of pharma sales.)

The bright spots were Nexavar and Kogenate, which posted double-digit gains (in Euros) due to market growth, but they weren’t enough to offset the long-term decline of top products. In November 2010, parent company Bayer AG announced a restructuring plan that would cover all of its major units. More than one-third of the 4,500 layoffs planned in the $1.3 billion overhaul will come from Germany; 2,500 new hires are also planned, primarily in emerging markets. The company didn’t break down the layoffs by unit — Healthcare, Crop Science and Material Science — but it’s believed that pharma will take the brunt of it. The moves are expected to generate $1.1 billion in annual savings.

Bayer’s prospects for growth appear tied to Xarelto, its warfarin- and Lovenox-buster co-developed with J&J. Xarelto has been available in Europe since 2008 and is on the market in 75 countries, but the FDA has yet to clear it. Bayer predicts peak sales of nearly $3.0 billion for the drug, but it’ll need to convince the agency that the benefits offset the bleeding risks. The company also has high hopes for its age-related macular degeneration treatment, VEGF Trap-Eye.

In May 2011, Bayer AG’s new chief executive officer, Marijn Dekkers (appointed in October 2010), mentioned that he was open to a “merger of equals” for the healthcare unit, as long as it won’t cost too much and Bayer doesn’t give up control. Thus ends the competition for the most unrealistic comment by an industry CEO this year.  —GYR

Previous Profile: Takeda // Next Profile: Boehringer-Ingelheim

Headcount: 36,300 (Pharma)
Pharma Revenues: $13,344 (-1%/+5%)
Total Revenues: $43,468 (-10%/-5%)
Net Income: $1,895 (-25%/-21%)
R&D Budget: $2,19 (2flat/+6%)

Revenues converted at average exchange rate / based on reported currency (Euro)

Account for 62% of total pharma sales, up from 61% in 2008.

PROFILE

Last year, Bayer promised to build some oncology partnerships to grow its pipeline, and it sure followed through, inking deals with Celera (June 2009), Algeta (Sept. 2009), Micromet (Dec. 2009), Prometheus (March 2010), and OncoMed (June 2010). That’s a good thing, because the company’s non-oncology products were in the doldrums in 2009, with none showing greater than 6% growth in Euros. Taking the Euro’s depreciation into account, none of Bayer’s major pharma products were up more than 1% in 2009, except for cancer treatment Nexavar, which posted 24% boost (30% in Euros).

It didn’t help that top seller Yasmin was under attack on two sides in the U.S. market: an authorized generic from Barr, and a possible connection to venous thrombosis. In May 2010, Bayer received approval for Natazia, a new class of oral contraceptive (available in the EU since May 2009). The company predicts peak U.S. sales of Natazia around $600 million, which would be a great boost for Bayer’s women’s health franchise, consider the Yaz family dropped another 10% (in Euros) in 1Q10. Overall, the company anticipates “below-market growth” for its pharma unit in 2010.

Luckily, Nexavar’s still going strong. Currently approved to treat liver and advanced kidney cancers, Nexavar is in trials for beast, ovarian and thyroid cancers. Bayer and partner Onyx were dealt a setback in June 2010 when Nexavar failed to prolong survival in advanced non-small cell lung cancer. However, the drug did manage to satisfy its progression-free survival goal in that trial, so there’s a chance that it can still get an NSCLC indication in combination with other treatments.

Bayer’s oncology pipeline may also get a boost from regorafenib, which entered Phase III trials for metastatic colorectal cancer in May 2010. Unfortunately, regorafenib is so similar to Nexavar that Onyx filed suit against Bayer last year for secretly synthesizing and patenting Nexavar analogs, in violation of their partnership.

The company’s other pipeline hope is riociguat, an oral treatment for pulmonary hypertension. After strong Phase II results, the drug is currently enrolling for Phase III trials in several indications, including pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD).

Of course, it’s not all great news In January 2010, the company threw in the towel on BAY79-4980, its long-acting recombinant factor VIII for hemophilia, after interim Phase II results couldn’t demonstrate non-inferiority against Bayer’s Kogenate. It’s still working on a long-acting hemophilia treatment, with the goal of developing a once-a-week treatment. The company plans to start trials of a PEGylated factor VIII later this year, as that version had a doubled half-life in preclinical models.

Bayer is facing a year in the doldrums, but Natazia and Nexavar give it a little light.

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Headcount: 108,600 (53,100 in pharma)
Pharma Revenues: $13,803 (+12%/+5%*)
Total Revenues: $48,434 (+9%/+2%*)
Net Income: $2,529 (-61%/-64%*)
R&D Budget: $2,266 (+9%/+1%*)

* converted at avg. exch. rate / based on local currency (Euro)

Account for 63% of total pharma sales, up from 59% in 2007.

PROFILE

Bayer Schering Pharma’s 2008, following up the most successful year in its history — attributed in part to the Schering integration — was sobering for Germany’s largest drug-maker. Bayer’s corporate strategy however, appears to be on the right track (if we consider investment in R&D to be the right track). According to Werner Wenning, chairman of the board of management, “In these turbulent times we could, of course, help to improve earnings in the short term by cutting back on research. But that would not be a sustainable strategy. It would simply be short-sighted.”

The company plans to fortify its research activities with a $4.0 billion R&D budget for 2009, the highest in the company’s history. Some recent R&D investments include bulking up its oncology pipeline through alliances, and license deals, as well as the acquisition of Maxygen’s hemophilia program assets, including next-gen recombinant Factor VIIa protein MAXY-VII, in a transaction valued at $90 million.

Bayer’s investment in the Asia Pacific region has been escalating. Of its $15.4 billion in 2008 sales, Asia Pacific accounted for $2.3 billion, up 13%. Bayer will invest as much as $14 million in R&D activities in Singapore during the next five to eight years through cancer research pact with the National University of Singaporeand will invest approximately $140 million during the next five years to establish a global R&D center in Beijing, China.

On the other hand, in June, Bayer officially handed over worldwide rights to Campath to Genzyme, who will take over responsibility for the development and commercialization of the drug in MS. Bayer has also relinquished worldwide marketing and distribution rights to oncology drugs Fludara and Leukine. In turn, Bayer will receive future payments based on revenue.

In 2008, cancer drug Nexavar achieved 76% growth, offsetting the drop in hematology/cardiology sales (-13%), impacted by the suspension of Trasylol back in November 2007. The company also began marketing anti-thrombosis drug Xarelto in the EU. However, the NDA, filed in July 2008 by Bayer’s U.S. partner J&J, was met with a Complete Response Letter. Although no new clinical studies are required for approval, the FDA has some questions.

Fortunately, sales for the YAZ family of oral contraceptives, which despite the launch of a generic competitor for Yasmin, were up 22%. A deal with generics manufacturer Barr, supplements these revenues. As of July 2008, Bayer supplies Barr with a generic version of Yasmin and gets a fixed percentage of the revenues. The two companies have a similar agreement for the generic version of Yaz in the U.S. starting July 2011.

On the whole, the 2009 outlook remains dominated by uncertainty, but with any luck, Bayer will be rewarded for its faith in R&D.—KB

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Headcount: 106,200 (40,000 in pharma)
Pharma Revenues*: $12,294 (+44%)
Total Revenues*: $44,391 (+22%)
Net Income: $6,458 (+205%)
R&D Budget**: $2,081 (+32%)

* Pharma unit, not including diagnostic imaging revenues of $1.8 billion
** R&D only for Bayer Healthcare Pharmaceuticals unit

Account for 65% of total pharma sales, up from 58% in 2006.

*** First full year of sales

PROFILE

Bayer’s acquisition of Schering AG became official in mid-2006, creating Bayer Schering Pharma. The move led to a boost of nearly 50% in Bayer’s pharma revenues, enough to bump the company from 16 to 14 on our list, and leaving it temporarily within shouting distance of Schering-Plough.

SP will be moving on up, post-Organon, and Bayer Schering may be facing big problems in 2008. In March, a court overturned a key patent for Bayer’s top seller, Yasmin oral contraceptive, opening the door for Barr Laboratories to launch a generic. The drug accounted for around $500 million in U.S. sales in 2007 and was part of the Schering acquisition.

In June 2008, Bayer announced an authorized generic Yasmin with Barr beginning July 1, 2008, as well as an authorized generic of next-generation oral contraceptive Yaz by July 2011. The agreement stipulates that if Bayer gets the patent restored, it will receive a larger percentage of sales from Barr. Meanwhile, Bayer is suing Watson and Sandoz over their generic filing for Yasmin.

In worse news, BS pulled Trasylol, a treatment for bleeding during coronary artery bypass surgery, after a study reported a shocking increase in mortality among patients, compared to older treatments. One doctor estimated that use of Trasylol — and Bayer’s lack of disclosure about a post-market study of it — may have led to as many as 22,000 deaths. Here’s hoping Bayer saved some cash for a legal liabilities fund after spending around $23 billion to pick up Schering.