Boehringer Ingelheim

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Company Headquarters

900 Ridgefield Road, Ridgefield, CT 06877

Driving Directions

Brand Description

We have been transforming lives in healthcare since 1885. Our 53,000 employees in 130 markets create value through innovation by infusing long-term, sustainable thinking into our Human Pharma and Animal Health units.

Key Personnel

NAME
JOB TITLE
  • Hubertus von Baumbach
    CEO / President
  • Clive Wood
    Corporate Senior Vice President - Global Head, Discovery Research, Human Pharma Innovation Unit
  • Martha Brown
    Executive Director, Discovery Research Coordination
  • Randolph Legg
    Vice President, Sales
  • Khosrow Fozouni
    VP Respiratory Marketing and Established Brands
  • Christian Orth
    CFO
  • John learson
    Executive Director Global Head - End User Services
  • Christine Grygon
    Executive Director, Business Development and Licensing
  • Tina Patel
    Executive Director, Business Innovation & Access Solutions
  • Bonnie Donato
    Executive Director, HEOR VDT Primary Care
  • Sven Meyer
    Vice President, Insights & Analytics
  • Christine Marsh
    Vice President, Market Access
  • Everett Hoekstra
    Chief Financial Officer
  • Thomas Seck
    Senior Vice President Medicine & Regulatory Affairs
  • Richard Azan
    Executive Director, Head of U.S Marketing - ILD Business Unit
  • Debra Forster
    Vice President, Litigation, Government Investigations and Risk Management
  • Michele Baer
    Executive Director - Head, US Pharma Communications
  • John Bonasera
    Executive Director, Customer-Facing Effectiveness and Incentives
  • Steve Boren
    Vice President -Livestock Business and Head of US Swine Business
  • Kathy Collins
    Vice President & Head US Regulatory Affairs
  • Walter Comeaux
    Executive Director, US Animal Health Customer Experience
  • Scott DeWire
    Exec. Director, Head of BD&L, USA
  • David Edwards
    Executive Director Cardiovascular Marketing
  • Karen Iannella
    Vice President, US Communications & Patient Affairs; President BI Cares Foundation
  • Andrea Lockenour
    VP of US Intellectual Property, Human Pharma
  • Stephen Pagnotta
    Executive Director US Marketing Interstitial Lung Disease
  • Paul Petraro
    Executive Director, Global Head Real World Evidence Analytic (RWE) Center of Excellence
  • David Roberts
    Vice President Finance
  • Bjo?rn Ru?ter
    Therapeutic Area Head, Executive Director, CDMA Specialty Care, Oncology
  • Timothy Schmidt
    Vice President, Sales
  • Dean Seiler
    Executive Director, Health Systems Marketing
  • Sandy Sommer
    Senior Vice President Cardio/Metabolic Franchise
  • Rajeev Sukumaran
    Executive Director, IT
  • Duane Taylor
    Vice President of US Human Pharmaceutial Operations
  • Rene Ward
    Director of Executive, Change and Employee Communications

Yearly results

Sales: 22.9 Billion

Headcount: 53,565
Revenues: $28,265 (+6%)
R&D: $6,364 (+14%)
Pharma Revenues: $22,927 (+10%)

Sales in Boehringer Ingelheim’s pharma business increased 10% in 2023 to $23 billion, mainly driven by the established products of the Jardiance family as well as OFEV. The growing licensing business—in particular, the Skyrizi product licensed out to and sold by AbbVie—also contributed significantly to the positive development of the business.

Jardiance, a medicine for the treatment of type 2 diabetes that also reduces the risk of cardiovascular diseases for type 2 diabetics with pre-existing cardiovascular conditions, was the group’s best-selling pharma product for the fifth consecutive year. In addition, it has also been used since 2023 to treat people with chronic kidney disease. Overall, the Jardiance family generated sales of $7.4 billion, 27% higher than the previous year.

OFEV, the second most successful product in terms of net sales in 2023, recorded net sales of $3.5 billion and a growth rate of 9%. Furthermore, sales of the products Trajenta and Jentadueto for the treatment of type-2 diabetes increased slightly by 0.2% to $1.8 billion.

Meanwhile, Spirivia, which is used to treat chronic obstructive pulmonary disease (COPD) and asthma, saw net sales decline 17% while the anticoagulant Pradaxa fell by 24% compared to the previous year, despite continuing to be one of Boehringer Ingelheim’s top-selling medicines.

On the collaboration front, in October 2023 Boehringer Ingelheim and ZEISS Medical Technology entered a long-term strategic partnership to develop predictive analytics to enable early detection of eye diseases and prevent vision loss for people with serious eye diseases. Also in October, Boehringer Ingelheim joined forces with Precision Health Research, Singapore (PRECISE) in a new partnership with the joint aim of transforming healthcare and improving patient outcomes in Singapore and beyond.

In November 2023, Boehringer Ingelheim acquired privately-held T3 Pharmaceuticals AG, a clinical stage Swiss biotech company, for up to $501.7 million. T3 Pharma has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor micro-environments. T3 Pharma’s technology will bolster Boehringer Ingelheim’s array of novel immune-modulatory cancer treatments.

Also in November, Boehringer Ingelheim and IBM announced an agreement that will enable Boehringer to use IBM’s foundation model technologies to discover novel candidate antibodies for the development of efficient therapeutics.

In corporate restructuring news, in 2023 the BioXcellence division (biopharmaceutical contract production) was integrated into the pharma business. This organizational change aims to improve collaboration and increase efficiencies to provide patients with medicines even more reliably. The BioXcellence division achieved net sales of $1.2 billion in 2023, an increase of 6.5% compared to the previous year, driven by increased demand for market products from the company’s business partners.

Sales: 19.7 Billion

Headcount: 53,155
Revenues: $19,707 (+21%)
Net Income: $3,396 (+1%)
R&D: $5,388 (+22%)

In 2022, Boehringer-Ingelheim’s pharma revenue rose 21% to $19,707 million despite uncertainties such as Russia’s war in Ukraine, which caused rising energy prices, sharp increases in cost of living and geopolitical tensions. The company’s research focuses on cardiovascular and metabolic diseases, oncology, respiratory diseases, immunology, diseases of the central nervous system (CNS) and retinal health.

Jardiance, a medicine for treatment of type 2 diabetes that also reduces the risk of cardiovascular diseases for type 2 diabetics with pre-existing cardiovascular conditions, was the group’s best-selling Human Pharma product for the fourth consecutive year. In addition, in 2022, Jardiance was approved by the U.S (FDA) and the European (EMA) regulatory authorities for the treatment of heart failure with preserved ejection fraction.

Three other products also played a significant role in Boehringer Ingelheim’s success: Spirivia, which is used for the treatment of chronic obstructive pulmonary disease (COPD) as well as asthma, Trajenta, which is used for the treatment if type 2 diabetes, and Pradaxa, which is used to prevent strokes in patients with atrial fibrillation and for the prevention and treatment of thromboembolic disorders. Another milestone was reached in September 2022 with the approval of Spevigo (spesolimab) in Japan and the U.S. Spevigo is the first product to receive FDA approval for the treatment of generalized pustular psoriasis (GPP)—a rare, life-threatening neutrophilic disease.

Boehringer Ingelheim also launched several new partnerships and was able to strengthen its pipeline on this basis. For example, the company is working with Lifebit Biotech, a biomedical data analytics provider, to build a scalable data, analytics and infrastructure platform. The aim of this collaboration is to collect findings from large external biobanks, thereby accelerating the development of new drugs. Together with Evotec SE and bioMérieux, Boehringer Ingelheim also launched the company Aurobac Therapeutics SAS, which aims to develop novel antibiotic precision therapies to combat antimicrobial resistance.

A new grant program in partnership with the University of Tübingen, Germany, aims to explore new approaches to improving human and animal health through AI and data science methods. After the successful start of an initial joint development in 2020, the company also started another collaboration with Click Therapeutics to develop another digital health application for prescribing to patients with schizophrenia, which could be used alone or in combination with the drug therapy.

In April 2023, Boehringer Ingelheim inaugurated its state-of-the-art Biologicals Development Center (BDC) in Biberach an der Riss, Germany. The new high-tech facility underlines the company’s strong commitment to Germany and Europe as location for research and development for the care of patients around the world. With the investment of $382 million, Boehringer Ingelheim significantly enhances its innovation power and development of biopharmaceutical development capabilities in Germany.

Most recently, in May 2023, Boehringer Ingelheim broke ground on a major investment of $313 million to build a new Chemical Innovation Plant at its headquarters in Ingelheim, Germany.

Sales: 17.3 Billion

Headcount: 52,391
Pharma Revenues: $17,319 (+6%)
Net Income: $3,857
R&D: $4,673 (+26%)

TOP SELLING DRUGS

Drug Indication 2021 Sales (+/-%)
Jardiance Diabetes, type 2 $4,133 26%
Ofev Idiopathic pulmonar fibrosis $2,613 21%
Trajenta/Jentadueto Diabetes, Type 2 $1,628 3%
Spirivia COPD, asthma $1,624 -14%

In 2021, Boehringer Ingelheim’s pharma revenue rose 6% to $17,319 million despite logistical and production challenges caused by COVID-19. The company’s research focuses on cardiovascular and metabolic diseases, oncology, respiratory diseases, immunology, diseases of the central nervous system (CNS) and retinal health. Its major emphasis is on the development of medicines and new approaches and therapies to prevent, detect and treat chronic diseases.

Jardiance, a medicine for treatment of type 2 diabetes, which also reduces the risk of cardiovascular diseases for type 2 diabetics with pre-existing cardiovascular conditions, was the group’s biggest selling Human Pharma product for the third consecutive year. In addition, in 2021, the FDA awarded Jardiance a Breakthrough Therapy Designation for extended use in the treatment of heart failure. Moreover, this medicine was awarded a new indication through the EU’s approval of its use for the treatment of heart failure with reduced ejection fraction. At the same time, Ofev, which is used for the treatment of the rare respiratory disease idiopathic pulmonary fibrosis and increasingly also in a further indication—systematic sclerosis with interstitial lung disease—registered strong growth.

Three other products also played a significant role in Boehringer Ingelheim’s success: Spiriva, which is used for the treatment of chronic obstructive pulmonary disease as well as asthma, Trajenta, which is used for treatment of type 2 diabetes, and Pradaxa, which is used to prevent strokes in patients with atrial fibrillation and for the prevention and treatment of thromboembolic disorders.

In its Human Pharma business, the company completed its acquisition of NBE-Therapeutics AG at the start of the year. The Swiss biotech company supplements Boehringer Ingelheim’s research activities through an innovative platform for the development of an antibody-drug conjugate pipeline.

Furthermore, the company completed its acquisition of contract manufacturer Labor Dr. Merck & Kollegen GmbH, which was subsequently renamed to Boehringer Ingelheim Therapeutics GmbH. It is an important component of the company’s research activities in the field of oncology—which it has significantly stepped up over the past few years through its acquisition of Abexxa Biologics Inc. in September 2021.

Boehringer Ingelheim also expanded its portfolio of partnerships in the past financial year: the company is now working with the Lieber Institute for Brain Development in researching new methods for treating neuropsychiatric diseases. It also entered into a collaboration with the Twist Bioscience Corporation to utilize Twist’s proprietary antibody library to identify potential antibody candidates in various therapeutic areas.

In January 2022 Boehringer Ingelheim entered a target drug discovery partnership with Evotec SE focused on induced pluripotent stem cell (iPSC)-based disease modelling for ophthalmologic disorders. Through phenotypic screening of human iPSC-derived cells, supported by Evotec’s PanOmics platform, Evotec will identify small molecules able to modulate disease phenotypes, and then validate the underlying promising targets for potential therapeutic interventions.

Most recently, in June 2022, Boehringer Ingelheim signed an option to acquire Trutino Biosciences Inc., a San Diego-based biotech company. Trutino Biosciences is a pre-clinical stage biotech company dedicated to the discovery and development of next-generation cytokine therapies to treat immuno-oncology and autoimmune diseases. The ongoing research partnership between Boehringer Ingelheim and Trutino is part of an overarching effort to mobilize a patient’s immune system to fight cancer.

Sales: 17.7 Billion

Headcount: 51,944
Pharma Revenues: $17,705 (+3%)
Net Income: $3,761 (+13)
R&D: $3,696 (+7%)

TOP SELLING DRUGS

Drug Indication 2020 Sales (+/-%)
Jardiance Diabetes, type 2 $3,015 15%
Ofev Idiopathic pulmonary fibrosis $2,498 38%
Spirivia COPD, asthma $2,180 -13%
Trajenta/Jentadueto Diabetes, Type 2 $1,838 -3%
Pradaxa Atrial fibrillation $1,814 -2%

In 2020, Boehringer Ingelheim’s pharma revenue rose 3% to $17,705 million despite the Covid-19 pandemic. The company’s research focuses on cardiovascular and metabolic diseases, oncology, respiratory diseases, immunology, diseases of the central nervous system (CNS) and retinal health. Its major emphasis is on the development of medicines and new approaches and therapies to prevent, detect and treat chronic diseases.

The type 2 diabetes medicine jardiance, which also reduces the risk of cardiovascular diseases for type 2 diabetics with pre-existing cardiovascular conditions, was the group’s biggest selling Human Pharma product for the second consecutive year.
At the same time, ofev, which is used for the treatment of the rare respiratory disease idiopathic pulmonary fibrosis and increasingly also in a further indication—systemic sclerosis with interstitial lung disease—registered especially strong growth.

Three other products also played a significant role in Boehringer’s success: Spiriva, which is used for the treatment of chronic obstructive pulmonary disease (COPD) as well as asthma, Trajenta, which is used for treatment of type 2 diabetes, and pradaxa, which is used to prevent strokes in patients with atrial fibrillation and for the prevention and treatment of thromboembolic disorders.

In positive pipeline news, the European Commission approved an additional indication for Nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF). The approval came after the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in May 2020.

Also, the U.S. FDA recently granted Fast Track status to Boehringer and Zealand Pharma’s GLP-1/glucagon dual antagonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). BI 456906 is currently being evaluated in a Phase II study in adults with NASH and liver fibrosis with and without diabetes. The primary endpoint of the trial is the histological improvement of steatohepatitis without worsening of fibrosis after 48 weeks of treatment.

Still, not all projects can be completed successfully: In 2020, Boehringer and Bridge Biotherapeutics mutually agreed on the termination of the collaboration on an autotaxin inhibitor for fibrosing interstitial lung diseases including idiopathic pulmonary fibrosis (IPF).

In 2020, Boehringer reinforced its position in the area of immunoncology therapies by acquiring shares in the Canadian company Northern Biologics Inc., which was subsequently renamed BI IO Canada Inc. The group also expanded its portfolio of collaborations and partnerships: In the past year, Boehringer entered into new partnerships which include relationships with the U.S. firm Mirati Therapeutics, Inc., which is investigating the use of “PAN-KRAS” inhibitors in the fight against tumors, and with the Swiss company Numab Therapeutics AG, with the goal of developing and commercializing multi-specific antibody therapies for potential treatment of lung and gastrointestinal cancers as well as geographic atrophy. Another new partner, CDR-Life Inc., which is likewise headquartered in Switzerland, also focuses on the latter indication. On the other hand, Boehringer’s new cooperation with the British company Enara Bio Ltd. aims to discover novel antigens for future cancer immunotherapies.

With Click Therapeutics, the group is pursuing the development of a digital therapeutic for the treatment of schizophrenia. Boehringer signed an agreement to acquire NBE-Therapeutics AG in the area of oncology and lastly, Boehringer negotiated the acquisition of contract manufacturer Labor Dr. Merk & Kollegen GmbH.

Sales: 15.6 Billion

Headcount: 51,015
Pharma Revenues: $15,634 (+3%)
Net Income: $3,046 (+28%)
R&D: $3,038 (-16%)

TOP SELLING DRUGS

Drug Indication 2019 Sales (+/-%)
Jardiance type 2 diabetes $2,409 40%
Spiriva COPD, asthma $2,304 -19%
Trajenta type 2 diabetes $1,745 6%
Pradaxa atrial fibrillation $1,712 -2%
Ofev idiopathic pulmonary fibrosis $1,669 28%
Micardis hypertension $822 1%
Glyxambi diabetes $810 64%
Activase myocardial infarction, acute, Pulmonary embolism, stroke $502 11%
Atrovent asthma, COPD $479 6%
Stiolto Respimat COAD/COPD $471 24%

During the year, Boehringer Ingelheim strengthened its cancer immunology portfolio when it paid $366 million to acquire AMAL Therapeutics and its novel cancer vaccines platform. The Swiss biotech is focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform KISIMA. AMAL’s lead vaccine ATP128 is currently developed for stage IV colorectal cancer and recently began first-in-human trials. Boehringer plans to develop new therapies by combining assets from its cancer immunology portfolio with AMAL’s KISIMA immunization platform.

In positive pipeline news, Boehringer received approval from the U.S. FDA for Ofev (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.

Expanding its global reach and footprint in China, Boehringer initiated a capacity expansion at its commercial manufacturing site for biologics in China. The expansion covers an additional bioreactor and includes utilities and infrastructure to support GMP operations of 2x 2.000L single use bioreactor manufacturing lines.

Through its biopharmaceutical contract manufacturing business, the company began manufacturing the commercial supply of a monoclonal antibody out of its China manufacturing OASIS facility in 2019. This will be the first commercial drug manufactured in the Shanghai facility. Following the commercial manufacturing of a client’s antibody, a number of investigational drugs are in Boehringer’s contract manufacturing business pipeline for potential future market launch and commercial supply out of Shanghai.

On the research front, Boehringer entered several collaborations during the year to advance it pipeline. With the University of Texas MD Anderson Cancer Center it set up a new multi-year partnership to conduct collaborative research to advance therapies for various types of cancers, including gastrointestinal and lung cancers. The deal includes the establishment of a joint Virtual Research and Development Center, designed to enable effective data sharing and analysis between the organizations. New potential gastrointestinal and lung cancer therapies from Boehringer’s pipeline will be combined with MD’s drug development capabilities.

A collaboration and license agreement with Yuhan Corp. aims to develop a first-in-class dual agonist for the treatment of nonalcoholic steatohepatitis (NASH) and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. Yuhan will provide its expertise in FGF21 biology, obesity and NASH.

With Bridge Biotherapeutics, Boehringer formed a new collaboration and license agreement with the goal of developing Bridge’s autotaxin inhibitor, BBT-877, for patients with fibrosing interstitial lung diseases, including Idiopathic Pulmonary Fibrosis (IPF).

Lastly, Boehringer Ingelheim and Inflammasome Therapeutics inked a co-development and license agreement to develop up to three therapies for patients with retinal diseases. By combining Inflammasome’s unique intravitreal (IVT) drug delivery technologies with Boehringer Ingelheim’s compounds from its retinal disease pipeline portfolio, Boehringer aims to develop novel therapies for retinal diseases.

Sales: 15.2 Billion

Headcount: 50,370
Reveneus: $20,014 (-3%)
Pharma Revenues: $15,204 (flat)
Net Income: $2,373  (NM)
R&D: $3,619  (+3%)

TOP SELLING DRUGS  

Drug Indication 2018 Sales (+/-%)
Spiriva COPD, asthma $2,849 -11%
Pradaxa atrial fibrillation $1,755 8%
Trajenta type 2 diabetes $1,650 18%
Jardiance type 2 diabetes $1,726 51%
Ofev idiopathic pulmonary fibrosis $1,299 25%
Micardis hypertension $942 -5%
Glyxambi diabetes $493 143%

Boehringer Ingelheim ended 2018 with flat pharma sales of $15.2 billion. As in previous years, the respiratory medicine Spiriva achieved the highest sales contributions with $2.8 billion, but this was an 11% drop from the year before due mostly to patent expiry. All other major products in Boehringer’s portfolio performed well. The anticoagulant Pradaxa was the next top seller with $1.8 billion in sales followed by type 2 diabetes drugs Jardiance, which grew 51% to $1.7 billion and Trajenta, which grew 18% to $1.6 billion. Rounding out the companies billion dollar performers was idiopathic pulmonary fibrosis treatment Ofev, which recorded $1.3 billion, up 25%.

In June 2018, Boehringer unveiled major investment plans on the biologics R&D front, pumping roughly $262 million into a new Biologicals Development Center (BDC) at the company’s site in Biberach, Germany. The BDC is part of the company’s long-term strategy to grow its biologics pipeline, specifically immune oncology and immunology. The company’s share of new biologics has been consistently increasing over the past few years and has now reached 40%.

The BDC will integrate biologics analytical and process development as well as manufacturing for clinical studies into one unit, while at the same time increasing development capacity. Following a staggered launch beginning in 2020, the new building will be home to 500 employees.

The new BDC adds to a number of major recent investments in its global biopharmaceuticals network aimed at increasing mammalian cell culture capabilities. This includes a large scale biopharmaceutical facility in Vienna, Austria, a new biopharmaceutical facility in Shanghai, China, and the expansion of existing large scale biopharmaceutical capacities in Fremont, CA.

On the cancer research front, Boehringer and Vanderbilt University expanded an existing collaboration to develop anti-cancer compounds, and formed a collaboration with OSE Immunotherapeutics to jointly develop OSE-172, a cancer immunotherapy.

In terms of filings, FDA granted Fast Track to Boehringer’s nintedanib for the treatment of systemic sclerosis with associated lung disease. In addition, positive results were reported from a Phase III study confirming that Cyltezo, the first biosimilar from Boehringer to be approved by FDA, is equivalent to Humira. This is the first U.S. study to investigate an interchangeability designation for an adalimumab biosimilar.

Sales: 15.9 Billion

Headcount:  50,000
Pharma Revenues:  $15,930 (+5%)
LOSS: $235 (-112%)
R&D:  $3,687 (-1%)

TOP SELLING DRUGS  

Drug Indication 2017 Sales (+/-%)
Spiriva COPD, asthma $3,385 -6%
Pradaxa atrial fibrillation $1,723 4%
Trajenta type 2 diabetes $1,597 18%
Jardiance type 2 diabetes $1,207 133%

Boehringer spent much of the year working to get at the forefront of immuno-oncology research. 2017 brought great progress within external partnerships, with agreements in place investigating both cancer cell-directed therapies and immune cell-directed therapies. In a collaboration with UCLA’s Technology Development Group, Boehringer aims to develop a promising vaccine technology platform based on using the protein shell of a plant virus to deliver a self-replicating RNA vaccine cargo to cancer patients’ antigen-presenting cells, which in turn would direct the immune system to eliminate the cancer.

Another immuno-oncology partnership with Siama Therapeutics is trying to identify anti-cancer therapeutics that target tumor associated carbohydrate antigens (TACAs), which are present in the majority of solid tumors including ovarian, pancreatic, prostate, colon, gastric and breast. A third cancer-focused collaboration with AbeXXa Biologics aims to identify a new series of selective molecular targets for cancer from the many thousands of proteins found on the interior of a tumor cell. AbeXXa has received funding through the Boehringer Ingelheim Venture Fund for this research. In addition, Boehringer and Vanderbilt University expanded their already successful existing collaboration to develop novel anti-cancer compounds.

Boehringer is on the rise in the digital space as well, building Digital Lab “BI X” with focus on innovative digital solutions in healthcare. The start-up came after a €10 million investment, and will work with multiple business units including Biopharmaceuticals and Human Pharma within the company to develop prototypes for new products and solutions, and then test them together in pilot phases. In November 2017, Boehringer also launched a second digital platform, opnMe.com. The platform offers free and open access to selected preclinical molecules for non-clinical investigation to scientists worldwide. The goal is to create possibilities for further independent and collaborative discovery as well as the identification of novel treatment approaches for patients.

In other news, Boehringer announced a €230 million investment into a new Biologics Development Center at the company’s R&D site in Biberach, Germany. The center bundles biologics development, increases capacity, and expands the clinical supply network. The facility will launch in 2020, and will employ more than 500 staff.

Sales: 16.7 Billion

Headcount: 45,692
Revenues: $16,699 (+3%)
Net Income: $1,952 (+13%)
R&D: $3,279 (flat)

TOP SELLING DRUGS 

Drug Indication 2016 Sales (+/-%)
Spiriva COPD $3,155 -19%
Pradaxa atrial fibrillation $1,459 4%
Trajenta type 2 diabetes $1,188 20%
Micardis hypertension $1,010 -3%

While Boehringer’s top seller Spiriva fell faster than expected in 2016, diabetes drug Jardiance, with $460 million in sales, has the potential to surpass the company’s flagship product. With its new cardiovascular label, which was approved in the U.S. at the end of last year, EvaluatePharma estimates that 2017 in-market Jardiance revenues could top $929 million, rising to $3.5 billion by 2022.

Over the course of the next few years, Jardiance prospects could be further augmented if upcoming trials succeed in chronic heart failure patients with or without diabetes. However, Jardiance will compete with other products in the SGLT2 inhibitor class. Contenders include Johnson & Johnson’s Invokana, with trial results expected this year, and Astrazeneca’s Farxiga.

Boehringer has not been at the forefront of the immuno-oncology revolution, but it’s trying to make a mark in this field with a focus on combinations, specifically with cancer vaccines. Its strategy hinges on developing its anti-PD-1 antibody, BI 754091, which is only in Phase I development. The company plans to pair BI 754091 with various cancer vaccine approaches, including those using peptides, RNA and vectors, the most advanced of which are currently in clinical development.

The company also expanded its immuo-oncology efforts via an alliance with ViraTherapeutics to jointly develop a next-gen oncolytic virus therapy platform and to investigate ViraTherapeutic’s lead candidate VSV-GP alone and with other therapies.

Boehringer’s biosimilar endeavors include both early and late stage assets. Following postive results from the Phase III VOLTAIRE-RA study of its adalimumab biosimilar candidate BI 695501, the company is seeking regulatory approval from the FDA and EMA. Also, in a Phase I study, its bevacizumab biosimilar candidate has demonstrated bioequivalence to Avastin, an angiogenesis inhibitor that is used to treat a variety of cancers.

In the way of investments, the company established a digital lab as an independent subsidiary focused on digital solutions in healthcare, and opened a commercial production site for biopharmaceuticals in China. With the founding of BI X, Boehringer will develop prototypes for new products and solutions and test them with the company’s business units in pilot phases to help ensure that data accrued at BI X are being quickly integrated into the digital lab’s parent house.

Additionally, as part of the company’s efforts to grow its contract development and manufacturing of mAbs and recombinant proteins in China, the company recently opened a commercial production site in Shanghai. With an initial investment of more than €70 million, the site represents the first biopharma facility established by a leading, multinational biopharma manufacturer in China utilizing mammalian cell culture technology.

Sales: 16.2 Billion

Headcount: 47,501
Revenues: $16,167 (+11%)
Net Income: $1,723 (+51%)
R&D: $3,282 (+13%)

TOP SELLING DRUGS 

Drug Indication 2015 Sales (+/-%)
Spiriva COPD $3,882 10%
Pradaxa atrial fibrillation $1,406 7%
Micardis hypertension $1,044 -12%
Trajenta type 2 diabetes $993 43%

Jumping four spots to 15, this year proved more successful for Boehringer Ingelheim, having overcome market challenges with pricing in the U.S. for its top selling drugs, and winning approval of Praxbind, a much needed reversal agent for Pradaxa, which helped boost sales that were beginning to slip in 2014 due to the potential dangers of internal bleeding.

Having been named one of the most innovative companies worldwide in 2015, this research-driven pharmaceutical company ranked among the 100 leading global innovators named by news agency Thomson Reuters. Key efforts to remain highly competitive included the sale of its generics business, U.S. subsidiary Roxane, and at the end of 2015. Also, Boehringer entered strategic negotiations with Sanofi to trade its consumer health care business for Sanofi’s animal health business. Shortly thereafter, Boehringer made a strategic investment of .5 billion euros to expands its biopharmaceutical production facility in Vienna.

While the company is pursuing biosimilars, we’ll focus on innovative efforts for the sake of space. With looming patent expirations for Boehringer’s bestseller, respiratory drug Spiriva, it won’t be long before new products are needed to replace future lost sales of the $3.9 billion drug. The significant approval of Praxbind in the U.S. and Europe means that Boehringer now has an agent that reverses the anticoagulant effect of Pradaxa, which is Boehringer’s second top seller.

In Boehringer’s prime indication area, respiratory diseases, the company gained key product approvals in several countries: Spiriva Respimat for asthma, Spiolto for chronic-obstructive pulmonary disease (COPD) and OFEV, which is used to treat the rare disease idiopathic pulmonary fibrosis (IPF) and has been shown to slow disease progression. A Phase III study of OFEV (Nintedanib) in people with systemic sclerosis and lung fibrosis is underway.

Further, the FDA approved Gilotrif (afatinib) as a new oral treatment option for patients with squamous cell lung cancer, providing a new second-line treatment option for patients with the second largest sub-type of non-small cell lung cancer (NSCLC), representing about 20-30% of cases. Studies showed significantly improved overall survival and progression-free survival compared to Genentech’s Tarceva (erlotinib). Gilotrif is already approved in more than 60 countries for the treatment of distinct types of EGFR mutation-positive NSCLC.

Additionally, a head-to-head study demonstrated Gilotrif significantly improved clinical outcomes compared to AstraZeneca’s Iressa (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer.

In metabolic diseases, under the Boehringer/Lilly alliance, the FDA approved Synjardy (empagliflozin and metformin hydrochloride) tablets for the treatment of type 2 diabetes. Synjardy is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi

(empagliflozin/linagliptin). The Synjardy combination uses complementary mechanisms of action to help control blood glucose. Empagliflozin is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death in a dedicated outcome trial.

Among late stage assets and alliances, Boehringer and AbbVie partnered to develop and commercialize BI 655066, an anti-IL-23 monoclonal antibody in Phase III development for psoriasis. Boehringer’s BI 655066 cleared skin better, faster and for longer than Janssen’s Stelara (ustekinumab) in a Phase II psoriasis trial. The companies are also evaluating the drug’s potential in Crohn’s disease, psoriatic arthritis and asthma.

Boehringer’s third generation EGFR TKI, BI 1482694, received FDA Breakthrough Therapy Designation for the treatment of non-small cell lung cancer and has the potential to become a new treatment option for patients. Phase I/II data showed 62% objective responses in patients, including 46% with confirmed tumor response. A new global Phase II trial is enrolling patients.

Additionally, Boehringer expanded its position in lung cancer obtaining exclusive rights from Hanmi Pharmaceutical to HM61713, a novel 3rd generation EGFR targeted therapy. This new partnership aims to achieve market authorization for HM61713 for patients with EGFR mutation-positive NSCLC by 2017 in the U.S.

Some early stage R&D efforts include collaborations with Inventiva, BioMed X, and The University of Texas MD Anderson Cancer Center. The Inventiva alliance is and example of Boehringer’s focus on external innovation and aims to develop potential new treatments for idiopathic pulmonary fibrosis and other fibrotic diseases. The BioMed X collaboration aims to identify novel approaches for the treatment psychiatric diseases, and the alliance with MD Anderson Cancer Center will explore new medicines to treat pancreatic ductal adenocarcinoma (PDAC).

Lastly, Boehringer exercised its option under the Oxford Bio Alliance, gaining exclusive rights to an oncology target. This is the second option exercised under the companies’ oncology alliance established in 2013. Boehringer appears well positioned to resume steady growth.

Sales: 12.9 Billion

Headcount: 47,700
Revenues: $12,887 (-17%)
Net Income: $1,064 (flat)
R&D: $3,316 (-1%)

TOP SELLING DRUGS  

Drug  Indication 2014 Sales (+/-%)
Spiriva COPD $3,935 -9%
Pradaxa atrial fibrillation $1,456 -1%
Micardis hypertension $1,322 -21%
Combivent COPD $684 -21%

In 2014 Boehringer managed to emerge no worse for the wear despite market challenges, particularly in the U.S. where sales were down 7%. Tougher regulation and pricing pressures hit the pharma business hard, impacting sales of its top sellers Spiriva, Micardis, and Combivent, and Pradaxa’s plight following reports of internal bleeding didn’t help matters.

BI did manage to resolve some of its U.S. woes, where severe cuts as a result of healthcare reform weren’t the company’s only problems. The FDA lifted a warning letter issued regarding the company’s manufacturing facility in Ingelheim, Germany that cited cGMP violations for the manufacture of APIs and finished products. BI also sold its U.S. subsidiary Ben Venue (similarly fraught with manufacturing violations), and settled litigation regarding Pradaxa, reaffirming the safety and efficacy profile following injury lawsuits in the U.S.

Furthermore, Idarucizumab, a drug to reverse blood thinning, was granted priority review by the FDA in April after data showed the potential to provide immediate reversal of the anticoagulant effect of Pradaxa, which was the first to market in a new class of drugs to replace warfarin. However, this and other anticoagulants including J&J’s Xarelto and BMS and Pfizer’s Eliquis, can cause internal bleeding if the active ingredient fails to break down properly, thus creating a need for reversal agents. Should it gain approval, Idarucizumab may help bolster Pradaxa sales.

In the coming years BI hopes to compensate for sales declines with growth drivers Trajenta for type 2 diabetes, which already generated a 34% jump in sales to €636 million, and Pradaxa, which contributed €1.2 billion in sales in 2014.

While it may have been a challenging year, R&D successes saw the approval/launch of Striverdi Respimat for COPD, Jardiance, a combination of linagliptin and empagliflozin for type 2 diabetes, and Nintedanib for the treatment of idiopathic pulmonary fibrosis, and most recently approved for advanced lung cancer, which will be marketed as Ofev and Vargatef, respectively.

In addition to R&D assets listed above, BI is working on treatments for Alzheimer’s disease, schizophrenia, and other psychiatric disorders, and its immunology pipeline includes projects for severe psoriasis, spondylarthritis, and Crohn’s disease.

Sales: 19.4 Billion

Headcount: 46,228
Pharma Revenues: $14,919 (-5%)
Total Revenues: $19,26 (72%)
Net Income: $1,813 (-50%)
R&D Budget: $3,863 (-17%)

TOP SELLING PRODUCTS

Drug Indication  2013 sales (+/- %)
Spiriva COPD $4,866 0%
Micardis hypertension $1,933 -15%
Pradaxa atrial fibrillation $1,698 9%
Combivent COPD $974  -13%

Last year was a challenging one for Boehringer-Ingelheim, which shut down its Ben Venue sterile injectables plant and CMO business. The company has made some difficult decisions, for instance, leaving the Hepatitis C therapy business.  Boehringer-Ingelheim was several years of research into its experimental drug, faldaprevir, which has been fully validated and granted accelerated assessment by the European Medicines Agency, and had been the foundation of Boehringer Ingelheim’s hepatitis C treatment pipeline.

The decision seems pragmatic, since Gilead, AbbVie, J&J and BMS have all developed competing products. Boehringer Ingelheim will withdraw all pending marketing applications and is discontinuing development.

The company is focusing its efforts on immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.

Orphan drugs: B-I to participate in New expanded access program for IFP
The company’s New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA) and granted Priority Review designation. The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF), a rare, progressive and fatal lung disease.

In addition, the company has launched an open-label, multicenter expanded access program (EAP) in the U.S. for nintedanib, which will be available to patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have been diagnosed with the disease within the last five years, in accordance with the most recent guidelines according to the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT). The trial will not compare nintedanib as treatment with any other IPF therapy.

In diabetes, the Lantus biosimilar that the company developed with Eli Lilly has been approved for review in the E.U., and Boehringer-Ingelheim has resubmitted an NDA for its investigational sodium glucose co-transporter-2 (SGLT2) inhibitor. The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

Empagliflozin is an investigational SGLT2 inhibitor being studied for the reduction of blood glucose levels in adults with diabetes. The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. The drug was studied in one of the largest clinical trial programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with type 2 diabetes.

In the respiratory therapy area, Boehringer Ingelheim has filed marketing authorization applications in 31 European countries for a new chronic obstructive pulmonary disease (COPD) therapy.  It is a daily,  fixed-dose combination of tiotropium and olodaterol, delivered via the Respimat Soft Mist Inhaler as a maintenance bronchodilator treatment for COPD patients.

Tiotropium, marketed under the brand name Spiriva, has been proven to consistently reduce the risk of COPD exacerbations, while providing long-term quality of life benefits and a favourable impact on survival. Meanwhile, olodaterol—also known as Striverdi—was specifically designed as a combination partner to tiotropium.

Boehringer Ingelheim is evaluating the new combination in the Phase III clinical trial program, which involves more than 8,000 patients and has already generated encouraging data.

In addition, the company has received European approval for its blood clot treatment, Pradaxa, used in the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism.   FDA has also given breakthrough status to idarucizumab, an antidote to its drug, Pradaxa.

Pradaxa has been developed as a more convenient alternative to warfarin and heparin.  However, there have been no antidotes to reverse its effects when patients develop severe bleeding. This fast-track status gives the company a competitive advance in a market where it competes with Bayer/Janssen’s Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban).

Sales: 14.7 Billion

Headcount: 46,228
Pharma Revenues: $14,66 (54%)

Total Revenues$18,89 (03%)

Net Income$3,594 (75%)

R&D Budget $3,29 (60%)

Top Selling Drugs

Drug Indication $ (+/- %)
Spiriva COPD $4,580 4%
Micardis hypertension $2,087 -6%
Pradaxa atrial fibrillation $1,425 63%
Combivent COPD $1,135 6%

Account for 63% of total pharma sales, up from 51% in 2011

Pradaxa remains the big story at Boehringer Ingelheim, in more ways than one. The oral anticoagulant posted mammoth results in 2012, reaching blockbuster status in its second full year, with $1.4 billion in sales. It’s also attracted a sizable amount of injury lawsuits in the U.S. due to internal bleeding side effects. The FDA has received a large number of post-marketing reports of GI bleeding in patients who have used Pradaxa, but in November 2012, the agency concluded that those rates are no higher than with new users of the standard treatment, warfarin, but will continue to evaluate the data for its ongoing safety review. (It doesn’t hurt that an “antidote” for Pradaxa is in development, to help counter some of those excessive bleeding episodes.)

Pradaxa now has two competitors on the market in J&J/Bayer’s Xarelto and Pfizer/BMS’ Eliquis, but those drugs have plenty of ground to make up, after Pradaxa’s huge U.S. launch. In 1Q13, Xarelto posted $158 million in sales, while Eliquis, which was approved in December 2012, launched with $22 million in revenues. With three of these anticoagulants on the market, we’ll see how the FDA chooses balances the risk-benefit ratio as more data comes in.

Pradaxa was approved in China in February 2013, a critical market for BI. The company reported 32% growth in China in 2012, one of only three companies to increase market share in that span.

In January 2013, the FDA gave priority review (and orphan drug) status to BI’s non-small cell lung cancer treatment afatinib, which recently demonstrated a near-doubling of progression-free survival against chemotherapy. BI expects the agency to take action on the NDA by 3Q13, along with a companion diagnostic co-developed with Qiagen.

BI is also making progress in its diabetes partnership with Lilly. Following on the approval of Tradjenta, the companies submitted empagliflozin, an oral SGLT2 inhibitor, for approval in both the EU and U.S. for the reduction of blood gluclose levels in patients with type 2 diabetes.

However, in January 2013, BI terminated development of one of the Lilly compounds it was working on, a novel basal insulin analog, citing “independent strategic portfolio considerations.” Lilly plans to continue development and submit the treatment to the FDA as early as 2014.

With Spiriva showing solid growth (13% in Euros) and Pradaxa continuing its boom, BI’s position seems secure.

Sales: 14.1 Billion

Headcount: 44,094
Pharma Revenues: $14,058 (9%)
Total Revenues: $18,339 (10%)
Net Income: $2,055 (74%)
R&D Budget: $3,303 (8%)

Top-Selling Drugs

Drug Indication $ (+/- %)
Spiriva COPD $4,390 16%
Micardis hypertension $2,218 8%
Combivent COPD $1,067 11%
Pradaxa atrial fibrillation $876 965%
Account for 61% of total pharma sales, up from 54% in 2010
PROFILE

Boehringer Ingelheim’s oral anticoagulant Pradaxa had one of the great launches in recent memory, posting $872 million in revenues in its first full year. That success offset the loss of Mirapex revenues ($887 million in 2010, unreported in 2011), but how long will it last?
Not only is Pradaxa going to face competition from Xarelto and (presumably) Eliquis, the drug’s safety has been questioned by the FDA and EMA. BI has argued that the rate of serious adverse events (particularly fatal bleeding) among Pradaxa patients has been lower than would have been experienced had the patients been using Warfarin, the standard of treatment, but both regulatory bodies are considering adding guidance for doctors and patients on lowering bleeding risks. This may include a change in dosing. Xarelto has already received a black box on its label and received a negative recommendation to expand its label; it remains to be seen whether Pradaxa will have similar problems.
BI is also optimistic that Tradjenta, the DPP-4 inhibitor it launched with Lilly in May 2011, will take off, especially in a combination form with Metformin to compete with Merck’s Janumet. For now, neither BI nor Lilly revealed Tradjenta revenues in their 2011 statements, and Lilly didn’t report numbers for it in 1Q12. Onglyza, BMS and AZ’s DPP-4 inhibitor, took some time to build momentum in the market, reaching $475 million in revenues in its second full year on the market.
BI and Lilly will have to find that momentum outside of BI’s home country. Germany’s new pricing policy, based on comparator cost-effectiveness, has put the kibosh on Tradjenta’s launch there.
While BI develops these two new products, as well as its late-stage pipeline, like lung cancer treatment afatinib, the company also has to keep an eye on its top moneymaker, Spiriva. A meta-analysis in British Medical Journal last year found an increase in mortality risk for people using Spiriva in its Respimat mist form (a dosage that’s not approved in the U.S.). A more recent meta-study published in BMJ Open in May 2012 found a lower mortality risk for Spiriva, but an increase in stroke, angina and myocardial infarction.
For the moment, Pradaxa will let Boehringer Ingelheim breathe a little easier.

Sales: 12.9 Billion

Headcount: 42,224
Pharma Revenues: $12,883 (-8%/-4%*)
Total Revenues:$16,713 (-6%/-1%*)
Net Income: $1,179 (-52%/-50%*)
R&D Budget: $3,257 (5%/+11%*)

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

Top-Selling Drugs in 2010

Drug

Indication

$

(+/- %)

Spiriva

COPD

$3,802

13%

Micardis

hypertension

$2,065

6%

Sifrol/Mirapex

Parkinson’s disease, restless legs

$887 -21%

Combivent

bronchodilation

$965

6%

Account for 60% of total pharma sales, up from 52% in 2009.

PROFILE

Boehringer-Ingelheim took a tumble in this year’s ranks, impaired by a weakening Euro and the loss of patent protection for Flomax and Mirapex. That double-whammy led to the second-largest revenue drop among our companies (the currency shift accounted for around half of the drop), more than offsetting a strong performance by COPD drug Spiriva.

BI didn’t break out its 2010 Flomax revenues (nor return my calls about it), but here’s a point of reference for how much it may have lost: 2009 sales were $2.0 billion, and the 8-week exclusivity period for Impax Pharmaceuticals’ generic version, launched March 2, 2010, brought that company $200 million in revenues. Add in another seven months of sales by multiple generics firms, and it’s not hard to see why Flomax didn’t make BI’s top-sellers list. BI is trying to recoup some of its sales by shifting Flomax to OTC status in UK, a process it hopes to repeat in other regions.

Thanks to those expirations, BI’s revenues in the Americas dropped 17% (12% in Euros) $6.1 billion. The Asia, Australasia and Africa (AAA) region grew 10% (15% in Euros) to $2.8 billion, illustrating that region’s importance.

So where’s the new revenue going to come from, besides AAA? In October 2010, BI gained FDA approval for Pradaxa, an oral anticoagulant, in reduction of stroke risk in patients with non-valvular atrial fibrillation. Pradaxa will compete in that area with grand-daddy Lovenox, along with Bayer/J&J’s Xarelto, AZ’s Brilinta, and Pfizer/BMS’ Eliquis, in a market that some analysts believe could reach $14 billion by 2018.

BI also has high hopes for its diabetes drug Tradjenta, a DPP-4 inhibitor. The drug was approved by the FDA in May 2011 and is supposed to be marketed in the U.S. by Lilly. “Supposed”, because Lilly’s other diabetes partner, Amylin, is suing to block the partnerships, contending it violates their long-standing diabetes pact. (See Lilly’s profile for more on that kerfluffle.) If the pact holds up, it could be worth billions for BI, since Tradjenta is easier on patients’ kidneys compared to existing DPP-4 inhibitors like Januvia and Onglyza. Some analysts project the DPP-4 market could reach $7 billion by 2015.

As long as Spiriva continues to rake in the sales and Pradaxa and Tradjenta can start to pick up some of the slack, BI should be able to keep pushing its R&D programs, which are heavy on oncology, cardiometabolic, and respiratory.  —GYR

Previous Profile: Bayer Healthcare // Next Profile: Astellas Pharma

Sales: 14 Billion

Headcount: 41,534
Pharma Revenues: $14,027 (+5%/+10%)
Total Revenues: $17,741 (+4%/+10%)
Net Income: $2,460 (+17%/+24%)
R&D Budget: $3,089 (flat/+5%)

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

2009 Top Selling Drugs
Drug Indication Sales (+/-%)
Spiriva COPD $3,353 +10%
Flomax prostate $1,972 +25%
Micardis hypertension $1,943 +8%
Sifrol/Mirapex Parkinson’s disease, restless legs syndrome $1,117 +1%

Account for 60% of total pharma sales, up from 56% in 2008.

 

PROFILE

Boehringer-Ingelheim posted mid-single digit gains (at average currency rates) and nearly passed Takeda in 2009 pharma sales. The company anticipates a flat 2010, as U.S. generic competition takes its toll Flomax, Mirapex/Sifrol and Catapresan TTS. BI doesn’t list sales of the latter drug, a hypertensive, but the company’s total U.S. pharma market comprised $6.3 billion last year, so they’re preparing to take a hit.

Relief may not come from Europe, where sales in local currency increased only 2% in 2009, but BI saw much better results from its pharma efforts in AAA (Asia, Australasia, Africa): sales were up 15% (in Euros) to $2.5 billion. In a press statement, Engelbert Tjeenk Willink, a member of BI’s board responsible for the pharma unit, remarked, “The fast growing markets such as Brazil, Russia, India and China in particular will offer Boehringer Ingelheim growth options in the future from which we intend to benefit.”

Acquisition News

Target: Fort Dodge Animal Health

Price: not disclosed

Announced: October 2009

What they said: “It significantly strengthens our position in vaccines and expands our reach in the companion animal and cattle segments. The widening of our segment focus and our product portfolio is driven by the opportunity to add further momentum to our internal growth strategy. We will build more capabilities, especially in the core vaccine segment, and expand our already strong product lines in vaccines and pharmaceuticals. This was an important step to achieve critical mass in the rapidly consolidating worldwide animal health industry.” —annual report

BI offered some fodder to chat-show monologues with its NDA filing for flibanserin, a treatment for hypoactive sexual desire disorder in premenopausal women. Jokes about “the female Viagra” abounded, but I promise not to repeat any of them here (or make new ones, although I will point out that it was sort of bizarre to name the various Phase III studies BOUQUET, DAISY, VIOLET and ORCHID). The drug got pummeled 11 to zero by an FDA advisory committee, which ascribed its decision to lack of proven efficacy along with such side effects as dizziness, nausea and fatigue. Several females members of the advisory panel encouraged BI to continue research in the field.

While flibanserin was making the momentary headlines, the real story at BI is Pradaxa, an anticoagulant that may turn into a billion-dollar baby. Already approved in the EU for the prevention of thrombosis and potentially life-threatening pulmonary embolisms following hip or knee replacement surgery, the drug may find a huge market if it succeeds in preventing strokes in patients with atrial fibrillation.

In its original indication, Pradaxa recently turned in Phase III results with hip surgery patients in which it demonstrated a comparable safety profile to Lovenox while faring much better in reducing venous thromboembolism (VTE) and VTE-related deaths.

The Lowe Down

Now, Boehringer Ingelheim stands out from everyone else in this list in an important way: they’re not a public company. And while that does, in theory, increase their cost of capital, it’s not like many people have been raising gigantic sums on the stock market for the last couple of years. Look what they get on the plus side, though: they can generally tell the public as much or as little as they want, and on their own timetable. No one wonders what Decision X or News Y is going to do to the stock (or their own stock options). Instead of a shareholder’s meeting, they have an Annual Press Conference. It’s a different world — hard to imagine, really.

Spiriva brings in the long green for them, for sure, and they have several other solid performers. But the recent fiasco with flibanserin for low female desire makes the company look a bit on the wrong side of the line that separates “innovative” from “desperate.”

One thing you don’t hear them doing very much is buying up other companies. Does the lack of stock make that harder, or do they just not want to go that route? In the same way, being privately held makes them basically immune to takeover rumors — like I said, it’s a different world. —Derek Lowe

BI celebrated the “topping-off” — more novel than a groundbreaking, in my opinion — of a Pradaxa manufacturing site in Ingelheim, Germany. Due to come online in 2011, the site will boost BI’s Pradaxa manufacturing capacity to 1.5 billion capsules a year. If it manages to get that stroke-prevention indication — and the company contends that a recent trial shows it could prevent one million strokes per year, besting standard-of-care warfarin — then it’ll need all the capsules it can make.

Why hasn’t BI filed an NDA/MAA for Pradaxa in this indication yet? Well, the same trial that showed a marked improvement against warfarin also showed a higher incidence of myocardial infarction (MI). Apparently, the incidences reached the level of statistical significance, so researchers are trying to figure out if warfarin is simply more cardio-protective than Pradaxa, or if there’s some other mechanism at work. That said, even the patients who suffered MIs had fewer strokes than the warfarin group.

Along with Pradaxa, BI’s R&D department also finished Phase III trials for its first DPP-4 inhibitor, linagliptin. DPP-4 inhibitors comprise a crowded marketplace, but the drug performed well enough that BI thinks it can carve out a niche. The company’s also pursuing a novel diabetes treatment, sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), which block tubular reabsorption of glucose in the kidney. BI is running Phase II trials in this class. In June 2010, the company signed a research pact with Neurocrine Biosciences to pursue a GPCR agonist to treat Type 2 diabetes.

In addition to diabetes, BI is also trying to build its oncology portfolio. The company is optimistic about the prospects of its new cancer treatment, an EGFR and HER2 receptor tyrosine kinase. The compound demonstrated anti-tumor effects in head and neck cancers, as well as non-small cell lung cancer, with Phase III data in NSCLC coming in soon. The company inked a pair of collaborations in the field in 2010. BI will pay Priaxon as much as $123 million in upfront payments and milestones for developments in mdm2/p53 regulators, and as much as $72 million in payments to Micromet to commercialize a BiTE antibody to treat multiple myeloma. Both pacts include royalties for commercialized products.

BI’s position as a privately held company (the only one in either of our lists) reduces the quarter-to-quarter pressure that its competitors feel. That doesn’t take the company completely off the hook when generics come calling, but it must make it easier to pursue its R&D agenda.

 

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Sales: 13.4 Billion

Headcount: 41,300
Pharma Revenues: $13,405 (+13%/+6%*)
Total Revenues: $17,060 (+14%/+6%*)
Net Income: $2,101 (-15%/-21%*)
R&D Budget: $3,103 (+19%/11%*)

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

2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Spiriva COPD $3,046 +24%
Micardis antihypertensive $1,794 +17%
Flomax prostate $1,582 +13%
Sifrol/Mirapex Parkinson’s disease, restless legs $1,106 +25%
Combivent respiratory $814 -8%

Account for 62% of total pharma sales, up from 60% in 2006.

PROFILE

COPD treatment Spiriva continues to rake in cash for Boehringer-Ingelheim, passing the $3.0 billion mark in 2008. Two of its other three blockbusters — Flomax and Mirapex — go generic in 2010, so the company is already anticipating a drop in earnings in the next few years. Until that happens, it’ll market those two products as best it can. BI is also working on a new extended release version of Mirapex.

As with every other company in our ranks, BI is optimistic about its pipeline. In its annual report, the company touted its boost in R&D spending, at a time when other companies are touting their cuts. Chairman Andreas Barner remarked, “High R&D costs with disproportionately large increases are a good sign at Boehringer Ingelheim: [it means] our pipeline is well-filled, in particular with substances in late-stage clinical development.”

And BI isn’t just trying to follow-on its own products with new formulations. In June 2009, BI presented results from Phase II trials for linagliptin at the American Diabetes Association annual meeting. The company hopes to establish itself in the Type 2 diabetes market with the once-daily oral treatment, which has five Phase III trials in progress at present. Linagliptin (no trade name yet) is a DPP-IV inhibitor, which puts it in the same class as Merck’s Januvia, last seen doubling its sales in 2008 to $1.4 billion (and jumping 51% in 1Q09 to $411 million). That class also includes BMS/AZ’s Onglyza, and Novartis’ Galvus and a slew of others in development.

BI also plans to expand its Alzheimer’s program with a research collaboration. The company entered a pact with its diabetes partner Vitae Pharmaceuticals in June 2009, to explore beta-secretase (BACE) inhibitors for the treatment of Alzheimer’s disease. The initial deal was for as much as $250 million in upfront payments and pre-royalty milestones.

Later this summer, BI plans to present data from several large trials of Pradaxa, its oral anticoagulant that reached the European market in March 2008. Pradaxa is being tested against stroke prevention in atrial fibrillation, treatment of acute venous thromboembolic events (VTE), secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome (ACS).

BI is looking at some bumps in the road with Flomax and Mirapex’s expirations next year, but its replacements are going after some high-profile targets.

 


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Sales: 11.1 Billion

Headcount: 39,800
Pharma Revenues: $11,103 (+15/+6%*)
Total Revenues: $15,012 (+13/4%*)
Net Income: $2,484 (+14/5%*)
R&D Budget: $2,371 (+20/10%*)

* Change based on local currency (Euro)

Top Selling Drugs
Drug Indication Sales (+/-%)
Spiriva COPD $2,456 +42%
Micardis antihypertensive $1,539 +27%
Flomax prostate $1,398 +21%
Combivent respiratory $887 +5%
Sifrol/Mirapex Parkinson’s disease, restless legs $883 +31%

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

PROFILE

On our charts, Boehringer Ingelheim’s results got a boost from the exchange rate, but even in local currencies, the German drug company’s top sellers posted solid growth in 2007, driven by Spiriva. This help it offset a loss of approximately $387 million from the patent expiration of Mobic. Overall, however, the company suffered a bit for its European base of operations, posting growth of only 3.6% in Euro terms. Unlike most of the companies in our ranks, BI actually increased its workforce in 2007, adding 1,400 people. Since 2003, the company has added 5,500 staffers.

The company did lose several people recently, as chairman Dr. Alessandro Banchi announced his retirement in June 2008, effective at the end of the year. His role will be filled by Dr. Andreas Barner, who was responsible for the R&D and Medicine division of the company’s board. Dr. Banchi, 62, spent 35 years at BI. Several more of BI’s long-time board members are retiring this year: Dr. Hans-Jurgen Leuchs (operations, animal health) and Prof. Marbod Muff (finance, HR).

In 2007, BI’s mature products produced the bulk of its sales growth, but the company is also developing a number of newer products with serious commercial potential. The company is trying to gain new indications for Cymbalta, which it co-markets with Lilly. Given Cymbalta’s performance in the U.S. ($1.8 billion in 2007 sales in that market), there’s reason to believe that BI will find some lucre with it in Europe.

BI’s new product with the biggest potential is Pradaxa, an anticoagulant that will battle Lovenox. The drug’s March 2008 EU approval beat a new entrant from Bayer by at least a year, allowing BI to build sales in a worldwide market where the top seller brought in $3.5 billion in 2007. If it can gain compelling post-market data from its EU (and Canadian) patients, BI may be poised to make a big splash in the U.S., but there’s no word on when an FDA submission is planned.

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