Genmab’s 20th anniversary year was truly a momentous one for the company, with breakthroughs achieved in all areas of our business. We advanced our innovative proprietary pipeline through additional products in the clinic and a variety of new strategic partnerships. Genmab’s partnered products also made tremendous progress with exciting data and multiple regulatory submissions and approvals. In addition to these developments with our pipeline, we more than accomplished our goals with our extremely successful Initial Public Offering (IPO) in the U.S., making Genmab a dual-listed company.
Our early-stage proprietary pipeline had unprecedented progress in its development over the course of 2019. We began the year with four Genmab owned (at least 50% ownership) products in clinical development and as of the end of the year this total was raised to six as DuoBody-PD-L1x4-1BB (GEN1046) and DuoBody-CD40x4-1BB (GEN1042), our products in co-development with BioNTech, entered into the clinic. With an investigational new drug (IND) filing for DuoHexaBody-CD37 in mid-November, we anticipate this total will soon be at seven, with more INDs planned for the coming year. We further broadened and strengthened our pipeline with multiple new strategic partnerships including an exclusive worldwide license and option agreement with Janssen for the development of HexaBody-CD38, a next-generation human CD38 monoclonal antibody product; a collaboration with Tempus to combine their sequencing capabilities and industry-leading platform of integrated clinical and molecular data with Genmab’s state-of-the-art translational, biomarker and target discovery expertise; and in December, we entered into an agreement with CureVac that will focus on the research and development of differentiated mRNA-based antibody products.
Following spectacular data in relapsing multiple sclerosis (RMS) in the third quarter of the year, the focus for ofatumumab now shifts to its potential in that indication. The highly anticipated data from the Phase III ASCLEPIOS I & II studies of subcutaneous ofatumumab was presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The trials met both the primary endpoints and key secondary endpoints with a safety profile in line with observations from prior Phase II results. Novartis, which is developing and commercializing ofatumumab, has stated that based on this data, they initiated a submission to U.S. health authorities for ofatumumab in RMS at the end of 2019. We are hopeful that in 2020 ofatumumab will become a new treatment option for patients with RMS.
This year was also a transformational one for DARZALEX, which is being developed and commercialized by Janssen Biotech, Inc. (Janssen), as over 100,000 patients have now been treated with DARZALEX since its launch in 2015. Approaching triple-blockbuster status for use in relapsed or refractory multiple myeloma, in 2019 DARZALEX received key approvals for newly diagnosed multiple myeloma as well as approvals and regulatory submissions for vastly more convenient modes of administration. In June, following review under the U.S. Food and Drug Administration’s (U.S. FDA) Real-Time Oncology Review (RTOR) pilot program, DARZALEX was approved in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This same indication was approved in Europe in November. An additional frontline indication, in combination with bortezomib, thalidomide and dexamethasone was approved in the U.S. in September. The key distinction with this approval is that it was for patients eligible for ASCT, making this the first quadruplet therapy approved for this patient population. Along with these new indications, the option to split the first infusion of DARZALEX over two days was approved in both the U.S. and in Europe. Even more convenient dosing may potentially be possible in 2020 based on Janssen’s regulatory submissions for approval of the subcutaneous formulation of daratumumab in the U.S. and in Europe. If approved this new formulation could become a game-changer as it reduces the time needed for dosing of daratumumab from several hours to just five minutes.
Of key importance in 2019 was our U.S. IPO, which enabled us to become a dual-listed company, trading on both the Nasdaq Copenhagen in Denmark and the Nasdaq Global Select Market in the U.S. Completed in July, the public offering and listing of American Depository Shares (ADSs) on the Nasdaq Global Select Market under the symbol “GMAB” led to gross proceeds from the issuance of new shares of USD 582 million (DKK 3,873 million) with a corresponding increase in share capital of 3,277,500 ordinary shares or 32,775,000 ADSs. This was the largest U.S. equity issuance by a biotechnology company in 2019, the second largest U.S. IPO ever by a biotechnology company and the largest IPO of ADSs by a European healthcare company.
This IPO was more than just an impressive one-time event; it allows us to diversify our shareholder base, support our growth into new competencies - including Translational Research, Data Sciences, Medical Affairs and Commercial - and it also increases Genmab’s visibility as a world-class antibody innovation powerhouse within the biotechnology industry and among key thought leaders in academia and the financial community.
Along with the Board of Directors and Senior Leadership at Genmab, I am committed to Genmab’s business-driven Corporate Social Responsibility (CSR) strategy as well as our efforts to build a sustainable organization that meets environment, social and governance (ESG) criteria of relevance to our business operations. Our CSR Committee is chaired by a member of our Executive Management Team and is comprised of representatives from a variety of development functions. Together, their goal is to ensure that Genmab carries out our CSR activities effectively and proactively communicates the results. In 2020, our goal is to review ESG considerations in closer detail and to integrate these into our strategic planning and risk management process. To this end, I am pleased to report that in 2020 we will form our first ever sustainability task force, which will be chaired by myself, to determine ESG matters of relevance to our business operations and establish clear goals to measure our performance.
Taken together, the events of the past year reveal a bright and exciting future for Genmab. We have delivered on our promise of building a robust and innovative pipeline of antibody therapeutics that creates value for both patients and for shareholders, and yet we are only at the beginning. Genmab is on a transformational journey both as a company, which grew by 200 employees in 2019, and as we work to revolutionize cancer treatment. I would like to thank the patients who participate in our clinical trials, the investigators who help us trailblaze innovations, our shareholders who believe in our commitment to transform cancer treatment and the dedicated team of Genmab colleagues who are determined to achieve our 2025 vision through our world-class expertise in antibody biology, innovation and technology.
Jan van de Winkel, Ph.D.
President & Chief Executive Officer