Delivering on Our Commitment

Total Page:16

File Type:pdf, Size:1020Kb

Delivering on Our Commitment Delivering on Our Commitment 2020 Annual Report Genmab A/S CVR No. 21 02 38 84 Table of Management’s Financial Contents Review Statements Using Science to Turn Insights into Medicine Our Purpose To improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is our reason for being. 2 2020 Annual Report Table of Management’s Financial Contents Review Statements Table of Contents Management’s Review Financial Statements 5 About Genmab 22 Our Business 85 Financial Statements for the Genmab Group 7 Timeline 23 Research and Development 8 2020 at a Glance Capabilities 133 Financial Statements of the Parent Company 9 Progress Toward Our 2025 Vision 24 Antibody Discovery and Development 149 Directors’ and Management’s 10 Chair’s Statement 25 Product Pipeline Statement on the Annual Report 12 Letter from the CEO 52 Antibody Technologies 150 Independent Auditor’s Report 15 Market Overview 59 Risk Management 17 2020 Achievements 63 Financial Review 18 Consolidated Key Figures 69 Shareholders and Share Information 153 Glossary 19 2021 Outlook 154 Forward Looking Statement 19 Key 2021 Priorities 71 Environmental, Social, and 155 Contact Information 20 Business Model Governance 21 Our Strategy 72 Commitment to Building a Sustainable and Socially Responsible Biotech Our Vision 73 Corporate Social Responsibility and Sustainability Commitments By 2025, our own 75 Human Capital Management 76 Stakeholder Engagement product has transformed 78 Corporate Governance cancer treatment, 80 Board of Directors and we have a pipeline 83 Senior Leadership of knock-your-socks-off antibodies 3 2020 Annual Report / Table of Contents Table of Management’s Financial Contents Review Statements Management’s Review 5 About Genmab 7 Timeline Management’s 8 2020 at a Glance 9 Progress Toward Our 2025 Vision 10 Chair’s Statement 12 Letter from the CEO Review 15 Market Overview 17 2020 Achievements 18 Consolidated Key Figures Genmab is at an inflection point in a transformational 19 2021 Outlook journey as the company evolves into a fully integrated 19 Key 2021 Priorities biotechnology innovation powerhouse, driven by its 20 Business Model mission to impact patients’ lives. 21 Our Strategy 22 Our Business 71 Environmental, Social, and Governance 4 2020 Annual Report / Management’s Review Table of Management’s Financial Contents Review Statements About Genmab Our Purpose Our Core Values To improve the lives of patients with cancer by creating In our quest to turn science into medicine, we use these guideposts and developing innovative and differentiated antibody to transform the future of cancer treatment: products. It is our reason for being. • Passion for innovation • Determination — being the best at what we do • Integrity — we do the right thing • We work as one team and respect each other Genmab’s Growing Organization Utrecht, NL – Research and Growing Presence – Translational Research – Antibody Product Creation – Corporate Functions Our Key Accomplishments Princeton, USA – Translational Research Tokyo, JP – Development – Clinical Copenhagen, DK – Commercial – Commercial – HQ Each of our achievements stands as evidence of our unyielding – Corporate Functions – Corporate Functions – CMC Operations determination, including: – Clinical Operations – Corporate Functions • Creators of multiple marketed products* • Inventors of four proprietary antibody technologies • Growing multiple proprietary clinical programs • Pioneers of a robust pre- clinical pipeline • World-class team with antibody and R&D expertise • Partnerships with industry leaders and innovators • Solid financial foundation • Building and expanding our capabilities with more than 750 employees across our four international locations * Products developed and marketed by others incorporating Genmab technology and innovation 5 2020 Annual Report / Management’s Review / About Genmab Table of Management’s Financial Contents Review Statements About Genmab Focused on Cancer Approved Medicines Created Our Pipeline by Genmab* Millions of people are diagnosed with cancer each year. Cancer DARZALEX® (daratumumab) Genmab is building a strong pipeline of proprietary antibody is the second leading cause of death worldwide, with about products that have the potential to make a real impact on the lives • Approved for the treatment of certain one in six deaths attributed to cancer. We believe antibody of cancer patients. When we consider which programs to develop, multiple myeloma indications in therapies are one of the keys to improving the lives of patients we look for differentiated antibodies that are first-in-class, offer territories including the U.S., Europe living with cancer. Our antibodies target two main categories of better efficacy than current treatments, or are better tolerated, and and Japan cancer: solid tumors and hematological cancers. have the potential to improve outcomes for cancer patients. In this • A subcutaneous (SubQ) formulation way we are building a knock-your-socks-off pipeline that offers Solid Tumors (daratumumab and hyaluronidase- multiple possibilities for success and the potential to meet our 2025 fihj), known as DARZALEX FASPRO® in the U.S., is approved Vision, while balancing the risks inherent in drug development. We A solid tumor is an abnormal mass of tissue for the treatment of certain multiple myeloma indications are also working on an extensive portfolio of pre- clinical programs that usually does not contain any liquid in the U.S. and Europe to fuel our pipeline of the future and bring us closer to achieving our or cysts. Solid tumors may be malignant • Marketed by Janssen Biotech Inc. (Janssen) 2025 Vision. (cancerous) or benign (non- cancerous). Solid tumors can occur in several places ® in the body, including the bones, muscles Kesimpta (ofatumumab) and organs. Sarcomas and carcinomas are • Approved in 2020 in the U.S. examples of solid tumors. in relapsing forms of multiple sclerosis (RMS) Hematological Cancers • Marketed by Novartis International AG Hematological cancers, also called blood (Novartis) cancers, begin in the tissues that form blood, 7Genmab-owned ≥50% products 3approved medicines ® such as the bone marrow, or in the cells of TEPEZZA (teprotumumab) in clinical development in collaboration the immune system. The three main types • Approved in 2020 in the U.S. in thyroid of blood cancers are leukemia, lymphoma eye disease (TED) and myeloma. • Marketed by Horizon Therapeutics plc (Horizon) Please see pages 28–37 of this Annual Report for detailed 15product candidates built on 4proprietary antibody indication and safety information. Genmab’s innovation in clinical technologies * Products developed and marketed by others incorporating Genmab technology development by other companies and innovation. 6 2020 Annual Report / Management’s Review / About Genmab Table of Management’s Financial Contents Review Statements Timeline A history of accomplishments rooted in science: From our start in Copenhagen in 1999, our continued commitment to oncology has given us purpose and a drive to improve the lives Key Events in Genmab’s of patients with cancer. We strive to achieve this goal by working together as one team and building on our world-class research in antibodies to expand our capabilities beyond the lab. 22-year Journey While we are proud of our past accomplishments for getting us to this point, we keep our eyes and minds focused on what is next. Our history has been powered by a dedication to developing antibody-based therapeutics. It is this same spirit that will guide us into the future. 1999–2002 2003–2007 2008–2011 2012–2015 2016–2018 2019 2020 • Genmab founded • CD38 MAbs generated • Arzerra® first U.S. and EU • Janssen DuoBody® • DARZALEX® first EU and • U.S. IPO • AbbVie Inc. (AbbVie) • Copenhagen IPO • Daratumumab selected approvals Research and License Japan approvals • Ofatumumab RMS sBLA partnership • First partnership (Roche) • GSK agreement • DuoBody® platform Agreement • HexElect® platform • CureVac AG agreement • First Phase 3 epcoritamab1 • Ofatumumab program ofatumumab • Strategy update • Janssen agreement • Immatics Biotechnologies • HexaBody-CD38 study announced announced • First collaboration daratumumab GmbH (Immatics) agreement (Janssen) • First clinical data with Seattle Genetics • HexaBody® platform agreement presented for DuoBody- (Seagen Inc.) • DARZALEX® first U.S. PD- L1x4-1BB2 approval • Very favorable topline • BioNTech SE (BioNTech) results in tisotumab agreement vedotin3 Phase 2 innovaTV 204 study • U.S. approvals for: – Kesimpta®4 – DARZALEX FASPRO®5 – TEPEZZA®6 • First regulatory submissions for product candidate created using DuoBody® technology7 1. Epcoritamab 50:50 partnership with AbbVie 3. Tisotumab vedotin 50:50 partnership with Seagen 5. DARZALEX® (daratumumab) and DARZALEX FASPRO® 6. TEPEZZA® (teprotumumab) developed by Horizon 2. DuoBody-PD-L1x4-1BB 50:50 partnership with BioNTech 4. Kesimpta® (ofatumumab) developed by Novartis (daratumumab and hyaluronidase-fihj) developed by Janssen 7. Amivantamab, developed by Janssen 7 2020 Annual Report / Management’s Review / Timeline 2 (C) Gensler Table of Management’s Financial Contents Review Statements 2020 at a Glance Operational Financial Approved Medicines in Collaboration Dual- listed DKK DKK • DARZALEX® marketed by Janssen in the U.S., in Denmark and in the U.S. Europe, Japan and multiple other countries 161B 16,079M • Kesimpta® marketed by Novartis in the U.S. 2020 year-end market cap 2020 year-end cash position†
Recommended publications
  • Genmab Announces Data to Be Presented at 2017 ASCO Annual Meeting
    Genmab Announces Data to be Presented at 2017 ASCO Annual Meeting Media Release 8 abstracts on Genmab programs scheduled for presentation at ASCO Two daratumumab oral presentations and five daratumumab poster presentations Copenhagen, Denmark; April 20, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that seven daratumumab abstracts have been accepted for presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 2 – 6. These abstracts, submitted by our collaboration partner, Janssen Biotech, Inc., include updates for the POLLUX and CASTOR trials, and the first data for a Phase I study evaluating daratumumab with carfilzomib, lenalidomide and dexamethasone in front line multiple myeloma patients, which will be presented in an oral presentation. In addition, descriptions of the Phase Ib/II study of daratumumab plus atezolizumab in non-small cell lung cancer and of our Phase I/II study with HuMax-AXL-ADC are scheduled for poster presentations at the meeting. The titles of the abstracts are currently available on the ASCO website with the full abstracts scheduled to be published on May 17, 2017. “We are very pleased that, once again, a number of abstracts based on exciting work with Genmab’s innovative therapeutic antibody products have been accepted for presentation at the prestigious ASCO conference,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. List of abstracts: Daratumumab: Efficacy Of Daratumumab In Combination with Lenalidomide Plus Dexamethasone (DRd) or
    [Show full text]
  • Genmab's 2020 Capital Markets
    WELCOME Genmab’s 2020 Capital Markets Day November 13, 2020 Webcast Live from Utrecht and Princeton Forward Looking Statement This presentation contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors.
    [Show full text]
  • Second Pre-Clinical Milestone Met in Lundbeck Collaboration - €1 Million Milestone Payment to Genmab
    GENMAB REACHES SECOND MILESTONE IN LUNDBECK COLLABORATION - Second pre-clinical milestone met in Lundbeck collaboration - €1 million milestone payment to Genmab Copenhagen, Denmark; February 10, 2012 – Genmab A/S (OMX: GEN) announced today it had reached the second pre-clinical milestone in the collaboration with H. Lundbeck A/S, triggering a €1 million payment. Genmab has reached the second milestone in the collaboration with H. Lundbeck A/S to create and develop human antibody therapeutics for disorders of the central nervous system (CNS). The milestone triggers a payment of €1 million to Genmab. Under the collaboration with Lundbeck Genmab creates novel human antibodies to three targets identified by Lundbeck and Lundbeck has access to Genmab’s antibody creation and development capabilities, including its state of the art, fully automated pre-clinical antibody screening and characterization capabilities and its proprietary stabilized IgG4 and UniBody therapeutic antibody platforms. Under the terms of the agreement, Genmab received an upfront payment of €7.5 million in October 2010 (approximately DKK 56 million). Lundbeck fully funds the development of the antibodies. If all milestones in the agreement are achieved, the total value of the agreement to Genmab would be approximately €38 million (approximately DKK 283 million), plus single-digit royalties. “We are very pleased to have met the in vitro proof of concept milestone for another target in the Lundbeck collaboration. This partnership is progressing well, with this second milestone coming shortly after we achieved the first preclinical milestone in December last year,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    [Show full text]
  • Bristol-Myers Squibb 2019 Annual Report
    We’re inspired by a single vision: 2019 ANNUAL REPORT Our Mission To discover, develop and deliver innovative medicines that help patients prevail over serious diseases Our Vision To be the world's leading biopharma company that transforms patients' lives through science The patient stories shared in this Annual Report depict individual patient responses to our medicines or investigational compounds and are not representative of all patient responses. In addition, there is no guarantee that potential drugs or indications still in development will receive regulatory approval. Bristol Myers Squibb 2019 Annual Report Myers Bristol Made Strong® is a registered mark of the Made Strong organization. Used with permission. Letter from the Chairman and CEO At Bristol Myers Squibb, we are inspired by our mission – to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Every day, we focus on innovations that drive meaningful breakthroughs so we can bring life-saving medicines to people around the world. 2019 was a transformative year for us. A BIOPHARMA LEADER THE POWER OF FOLLOWING THE SCIENCE The acquisition of Celgene Corporation significantly We start this next chapter at a time when unprecedented advanced our strategy to create a leading biopharma scientific breakthroughs are advancing the treatment company by bringing together the speed and agility of disease as never before. Bristol Myers Squibb is well of a biotech with the global scale and resources of an positioned in scientific hubs of innovation in the U.S. and established pharmaceutical company. Our new company globally, and we collaborate with a broad network of global has strong commercial franchises in oncology, hematology, partners across our disease areas of focus to sustain our immunology and cardiovascular disease, one of the most leadership and continue to transform patient outcomes.
    [Show full text]
  • Interim Report for the First Quarter of 2020
    Genmab Announces Financial Results for the First Quarter of 2020 May 6, 2020; Copenhagen, Denmark; Interim Report for the First Quarter Ended March 31, 2020 Highlights DARZALEX® (daratumumab) net sales increased approximately 49% compared to the first quarter of 2019 to USD 937 million, resulting in royalty income of DKK 775 million DARZALEX approved in Europe in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant U.S. FDA approved TEPEZZA™ (teprotumumab-trbw), developed and commercialized by Horizon Therapeutics, for thyroid eye disease U.S. FDA accepted, with priority review, Novartis’ supplemental Biologics License Application for subcutaneous ofatumumab in relapsing multiple sclerosis Anthony Pagano appointed Chief Financial Officer Anthony Mancini appointed Chief Operating Officer “Despite the unprecedented challenges posed by the coronavirus (COVID-19) pandemic, we will continue to invest in our innovative proprietary products, technologies and capabilities and use our world-class expertise in antibody drug development to create truly differentiated products with the potential to help cancer patients. While Genmab is closely monitoring the developments in the rapidly evolving landscape, we are extremely fortunate to have a solid financial foundation and a fabulous and committed team to carry us through these uncertain times,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Quarter of 2020 Revenue was DKK 892 million in the first quarter of 2020 compared to DKK 591 million in the first quarter of 2019. The increase of DKK 301 million, or 51%, was mainly driven by higher DARZALEX royalties.
    [Show full text]
  • Portfolio of Investments
    PORTFOLIO OF INVESTMENTS CTIVP® – Lazard International Equity Advantage Fund, September 30, 2020 (Unaudited) (Percentages represent value of investments compared to net assets) Investments in securities Common Stocks 97.6% Common Stocks (continued) Issuer Shares Value ($) Issuer Shares Value ($) Australia 6.9% Finland 1.0% AGL Energy Ltd. 437,255 4,269,500 Metso OYJ 153,708 2,078,669 ASX Ltd. 80,181 4,687,834 UPM-Kymmene OYJ 36,364 1,106,808 BHP Group Ltd. 349,229 9,021,842 Valmet OYJ 469,080 11,570,861 Breville Group Ltd. 153,867 2,792,438 Total 14,756,338 Charter Hall Group 424,482 3,808,865 France 9.5% CSL Ltd. 21,611 4,464,114 Air Liquide SA 47,014 7,452,175 Data#3 Ltd. 392,648 1,866,463 Capgemini SE 88,945 11,411,232 Fortescue Metals Group Ltd. 2,622,808 30,812,817 Cie de Saint-Gobain(a) 595,105 24,927,266 IGO Ltd. 596,008 1,796,212 Cie Generale des Etablissements Michelin CSA 24,191 2,596,845 Ingenia Communities Group 665,283 2,191,435 Electricite de France SA 417,761 4,413,001 Kogan.com Ltd. 138,444 2,021,176 Elis SA(a) 76,713 968,415 Netwealth Group Ltd. 477,201 5,254,788 Legrand SA 22,398 1,783,985 Omni Bridgeway Ltd. 435,744 1,234,193 L’Oreal SA 119,452 38,873,153 REA Group Ltd. 23,810 1,895,961 Orange SA 298,281 3,106,763 Regis Resources Ltd.
    [Show full text]
  • Portfolio of Investments
    PORTFOLIO OF INVESTMENTS Variable Portfolio – Partners International Value Fund, September 30, 2020 (Unaudited) (Percentages represent value of investments compared to net assets) Investments in securities Common Stocks 97.9% Common Stocks (continued) Issuer Shares Value ($) Issuer Shares Value ($) Australia 4.2% UCB SA 3,232 367,070 AMP Ltd. 247,119 232,705 Total 13,350,657 Aurizon Holdings Ltd. 64,744 199,177 China 0.6% Australia & New Zealand Banking Group Ltd. 340,950 4,253,691 Baidu, Inc., ADR(a) 15,000 1,898,850 Bendigo & Adelaide Bank Ltd. 30,812 134,198 China Mobile Ltd. 658,000 4,223,890 BlueScope Steel Ltd. 132,090 1,217,053 Total 6,122,740 Boral Ltd. 177,752 587,387 Denmark 1.9% Challenger Ltd. 802,400 2,232,907 AP Moller - Maersk A/S, Class A 160 234,206 Cleanaway Waste Management Ltd. 273,032 412,273 AP Moller - Maersk A/S, Class B 3,945 6,236,577 Crown Resorts Ltd. 31,489 200,032 Carlsberg A/S, Class B 12,199 1,643,476 Fortescue Metals Group Ltd. 194,057 2,279,787 Danske Bank A/S(a) 35,892 485,479 Harvey Norman Holdings Ltd. 144,797 471,278 Demant A/S(a) 8,210 257,475 Incitec Pivot Ltd. 377,247 552,746 Drilling Co. of 1972 A/S (The)(a) 40,700 879,052 LendLease Group 485,961 3,882,083 DSV PANALPINA A/S 15,851 2,571,083 Macquarie Group Ltd. 65,800 5,703,825 Genmab A/S(a) 1,071 388,672 National Australia Bank Ltd.
    [Show full text]
  • Quarterly Commentary—Artisan Non-U.S. Small-Mid Growth Strategy
    QUARTERLY Artisan Non-U.S. Small-Mid Growth Strategy FactCommentary Sheet As of 30 June 2019 Investment Process We seek long-term investments in high-quality businesses exposed to structural growth themes that can be acquired at sensible valuations in a contrarian fashion and are led by excellent management teams. Investing with Tailwinds We identify structural themes at the intersection of growth and change with the objective of investing in companies having meaningful exposure to these trends. Themes can be identified from both bottom-up and top-down perspectives. High-Quality Businesses We seek future leaders with attractive growth characteristics that we can own for the long term. Our fundamental analysis focuses on those companies exhibiting unique and defensible business models, high barriers to entry, proven management teams, favorable positions within their industry value chains and high or improving returns on capital. In short, we look to invest in small companies that have potential to become large. A Contrarian Approach to Valuation We seek to invest in high-quality businesses in a contrarian fashion. Mismatches between stock price and long-term business value are created by market dislocations, temporary slowdowns in individual businesses or misperceptions in the investment community. We also examine business transformation brought about by management change or restructuring. Manage Unique Risks of International Small- and Mid-Cap Equities International small- and mid-cap equities are exposed to unique investment risks that require managing. We define risk as permanent loss of capital, not share price volatility. We manage this risk by having a long-term ownership focus, understanding the direct and indirect security risks for each business, constructing the portfolio on a well-diversified basis and sizing positions according to individual risk characteristics.
    [Show full text]
  • Citi Pure Growth Europe Long-Short Net TR Series II Index (CIISGRE2)
    Date: 23-May-21 Index Weights as of monthly rebalance date 12-May-21 Citi Pure Growth Europe Long-Short Net TR Series II Index (CIISGRE2) Long Exposure Short Exposure Constituent Bloomberg Ticker Constituent Name Weight(%) Constituent Bloomberg Ticker Constituent Name Weight(%) 1 AAL LN Equity Anglo American Plc 1.62% 1 1COV GY Equity Covestro AG -0.89% 2 ACA FP Equity Credit Agricole SA 1.37% 2 ABBN SE Equity ABB LTD-REG -0.31% 3 ADM LN Equity Admiral Group 0.09% 3 ABF LN Equity Associated British Foods -0.62% 4 ADS GY Equity Adidas AG 1.01% 4 ABN NA Equity ABN AMRO Group NV -1.24% 5 ADYEN NA Equity Adyen NV 2.43% 5 AC FP Equity Accor -1.54% 6 AD NA Equity Ahold NV 0.61% 6 ADEN SE Equity ADECCO GROUP AG-REG -0.49% 7 AHT LN Equity Ashtead Group 0.24% 7 AENA SQ Equity AENA SA -1.05% 8 ALC SE Equity ALCON AG CHF0.04 0.70% 8 AGN NA Equity Aegon NV -0.71% 9 ALFA SS Equity Alfa Laval AB 0.11% 9 AI FP Equity Air Liquide -0.69% 10 ALO FP Equity Alstom 0.45% 10 AKZA NA Equity AKZO NOBEL NV EUR0.50(POST REV SPLIT) -0.37% 11 AMBUB DC Equity Ambu A/S 1.41% 11 ALV GY Equity Allianz SE -0.79% 12 AMP IM Equity Amplifon SpA 0.45% 12 AMS SQ Equity Amadeus IT Hldg SA -1.78% 13 ANTO LN Equity Antofagasta Hldgs 1.62% 13 VNA GY Equity Deutsche Annington Immobilien -0.27% 14 ASM NA Equity ASM Intl 0.65% 14 ASSAB SS Equity Assa Abloy B -1.11% 15 ASML NA Equity ASML Holding NV 0.82% 15 ATCOA SS Equity Atlas Copco AB A -0.68% 16 ATO FP Equity AtoS 0.51% 16 ATCOB SS Equity Atlas Copco AB B -0.66% 17 AZN LN Equity AstraZeneca Plc 0.38% 17 AV/ LN Equity Aviva -0.07%
    [Show full text]
  • Genmab Announces Antibody Development Collaboration with Lundbeck
    GENMAB ANNOUNCES ANTIBODY DEVELOPMENT COLLABORATION WITH LUNDBECK Summary: Genmab and Lundbeck enter into an agreement to develop antibody therapeutics. Copenhagen, Denmark; October 13, 2010 – Genmab A/S (OMX: GEN) announced today an agreement to create and develop human antibody therapeutics for disorders of the central nervous system (CNS) with H. Lundbeck A/S. Genmab will create novel human antibodies to three targets identified by Lundbeck. Lundbeck will have access to Genmab’s antibody creation and development capabilities, including its state of the art, fully automated pre-clinical antibody screening and characterization capabilities and its proprietary stabilized IgG4 and UniBody therapeutic antibody platforms. Lundbeck will have an option to take selected antibodies into clinical development at its own cost and subject to the payment of milestones and single-digit royalties to Genmab upon successful development and commercialization. Genmab will have a similar option to take selected antibodies into clinical development for cancer indications at its own cost and subject to the payment of milestones and single-digit royalties to Lundbeck. Under the terms of the agreement, Genmab will receive an upfront payment of €7.5 million (approximately DKK 56 million). Lundbeck will fully fund the development of the antibodies. If all milestones in the agreement are achieved, the total value of the agreement to Genmab would be approximately €38 million (approximately DKK 283 million), plus single-digit royalties. “We are pleased to enter into this collaboration with Lundbeck, world experts in the development of CNS therapeutics. It gives Genmab the opportunity to leverage our antibody technology and expertise and to expand our pipeline into a new and exciting therapeutic area without assuming a financial obligation,” said Jan van de Winkel, Chief Executive Officer of Genmab.
    [Show full text]
  • Bristol-Myers Squibb 2009 Annual Report
    DELIVERING ON OUR COMMITMENTS 2009 ANNUAL REPORT Bristol-Myers Squibb 345 Park Avenue • New York, NY 10154-0037 This QR-Code can be read with most standard 212-546-4000 • www.bms.com Smartphone QR-Code Reader Apps. ACME-COVER-2009 BMS AR.indd 1 3/8/10 4:59 PM FINANCIAL HIGHLIGHTS Net Sales Dollars in billions ON THE BACK COVER 2009 $18.8 Curtis Horne, a law enforcement officer, was 2008 $17.7 raised on “all the good things that tasted great.” All those “good things” caught up to him one 2007 $15.6 day in 2003 when he collapsed from a heart attack. Now, Curtis takes his medications and Earnings Per Share does everything that his doctor advises. “I eat (from continuing operations attributable to Bristol-Myers Squibb) fruits and vegetables and exercise regularly. GAAP These are the really ‘good things’ that are good for you,” he says. And when he plays with his 2009 $1.63 five grandchildren, he thinks, “I almost wasn’t here for this.” 2008 $1.35 At Bristol-Myers Squibb we believe that the 2007 $0.65 will of the patient, matched by our desire to Non-GAAP find breakthrough medicines, can make all the difference. For more about Curtis and others 2009 $1.85 who are prevailing over serious diseases, visit www.bms.com. 2008 $1.49 2007 $1.04 For further detail on management's use of non-GAAP financial information and reconciliation of non-GAAP to GAAP EPS, see “Management's Discussion and Analysis of Financial Condition and Results of Operations – Non-GAAP Financial Measures” enclosed and the “Quarterly Package of Financial Information” on the company's website at www.bms.com.
    [Show full text]
  • Nivolumab) from the U.S
    December 26, 2014 Bristol-Myers Squibb Receives Accelerated Approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration (Princeton, NJ – December 22, 2014) – Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human anti-human programmed death receptor-1 (PD-1) monoclonal antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy® (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Opdivo is a human anti-human PD-1 monoclonal antibody generated under a research collaboration entered into in May 2005 between ONO PHARMACEUTICAL CO.,LTD. (“ONO”) and the US-based company Medarex,Inc. When Medarex, Inc. was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the human anti-human PD-1 monoclonal antibody in North America. Through the collaboration agreement entered into in September 2011 between ONO and BMS, ONO granted BMS exclusive rights to develop and commercialize Opdivo in the rest of the world, except in Japan, Korea and Taiwan where ONO had retained all rights to develop and commercialize the compound. On July 23, 2014, ONO and BMS signed a new collaboration agreement in which the companies agreed to jointly develop and commercialize Opdivo, ipilimumab and three early-stage immunotherapies in Japan, South Korea and Taiwan. Furthermore, BMS has a robust clinical development program in a variety of tumor types overseas, including: Non-Small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC), Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Bladder Cancer.
    [Show full text]