We are an international biotechnology company specializing in antibody therapeutics for the treatment of cancer and other diseases. Our core purpose is to improve the lives of patients by creating and developing innovative antibody products. Our vision is to transform cancer treatment by launching our own proprietary product by 2025 and advancing our pipeline of differentiated and well-tolerated antibodies. We are building and expanding our late-stage development and commercial capabilities to allow us to bring our proprietary products to market in the future. Today, we have a well-diversified portfolio of products, product candidates and technologies. Our portfolio includes two marketed partnered products, daratumumab, marketed as DARZALEX® for the treatment of certain indications of multiple myeloma, or MM, and ofatumumab, marketed as Arzerra® for the treatment of certain indications of chronic lymphocytic leukemia, or CLL, in addition to a broad pipeline of differentiated product candidates. Our pipeline includes five proprietary product candidates in clinical development and approximately 20 proprietary and partnered pre-clinical programs, including two proprietary product candidates for which we have submitted or intend to submit an application for an investigational new drug, or IND, to the U.S. Food and Drug Administration, or FDA, and/or a clinical trial application, or a CTA, to the European Medicines Agency, or EMA, in 2019. In addition to our proprietary clinical product candidates and our partners' ongoing label expansion studies for daratumumab and ofatumumab, our partners have ten additional product candidates in clinical development through collaboration agreements with us. Our portfolio also includes four proprietary antibody technologies that play a key role in building our product pipeline, enhancing our partnerships and generating revenue. We selectively enter into strategic alliances with other biotechnology and pharmaceutical companies that build our network in the biotechnology space and give us access to complementary novel technologies or products that move us closer to achieving our vision and fulfilling our core purpose.
Use of proceeds:We estimate that the net proceeds from this offering will be approximately $472.6 million (DKK 3,132.2 million), after deducting the underwriting commission and estimated offering expenses payable by us, based on an assumed initial public offering price of $18.11 per ADS, the U.S. dollar equivalent of the closing price of our shares on Nasdaq Copenhagen of DKK 1,200.50 on July 5, 2019, at the U.S. dollar/DKK exchange rate of DKK 6.6283 per $1.00 as of July 5, 2019, multiplied by the ADS-to-share ratio of 10 to 1.If the underwriters exercise their option to purchase additional ADSs in full, we estimate that the net proceeds to us from this offering will be approximately $543.9 million (DKK 3,605.3 million), after deducting the underwriting commission and estimated offering expenses payable by us.Each $1.00 increase (decrease) in the assumed initial public offering price of $18.11 per ADS would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting commission and estimated offering expenses payable by us, by $26.3 million, assuming that the number of ADSs offered by us, as set forth on the cover page of this prospectus, remains the same.We may also increase or decrease the number of ADSs we are offering.An increase (decrease) of 10% in the number of ADSs we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting commission and estimated offering expenses payable by us, by $47.6 million, assuming the assumed initial public offering price stays the same.We intend to use the net proceeds from this offering to continue the development of our proprietary product candidates, to continue our pre-commercial activities, to continue building our commercial capabilities and to advance earlier stage product candidates.We intend to use the net proceeds from the offering as follows: • approximately $100.0 million to advance tisotumab vedotin to commercialization in recurrent and/or metastatic cervical cancer, to progress tisotumab vedotin in other solid tumor indications and to continue building our commercial capabilities in connection with the potential future approval of tisotumab vedotin; and • approximately $275.0 million to fund drug discovery efforts, to further our development of existing and new technology platforms, and to fund the development of our earlier stage clinical and pre-clinical programs, including: • the ongoing development of enapotamab vedotin in various solid tumor indications; • the ongoing Phase I/II clinical trial of HexaBody-DR5/DR5 for the treatment of solid tumors; • the ongoing Phase I/II clinical trial of DuoBody-CD3xCD20 for the treatment of B-cell malignancies; and • the launch and conduct of Phase I/II clinical trials following submission of INDs and/or CTAs in 2019 for DuoBody-PD-L1x4-1BB, DuoBody-CD40x4-1BB and DuoHexaBody-CD37.We intend to use any remaining net proceeds to maximize relationships with partners, to increase strategic flexibility to potentially retain significant ownership and value of select products and product candidates and for general corporate purposes.This expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve.We cannot predict with certainty all of the particular uses of the net proceeds of this offering or the amounts that we will actually spend on the uses set forth above.The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the relative success and cost of our research, pre-clinical and clinical development programs, our ability to obtain regulatory approvals in respect of our product candidates, changes in the competitive landscape, ongoing developments in our relationships with current and future partners, reduction in existing royalty streams and any unforeseen cash needs.As a result, management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding the application of the net proceeds of this offering.Pending our application of the net proceeds from this offering as described above, we plan to invest such proceeds in a variety of capital preservation investments, including short- and intermediate-term interest-bearing obligations and certificates of deposit.
Competition:The biotechnology and pharmaceutical industries generally, and the cancer drug sector specifically, are characterized by rapidly advancing technologies, evolving understanding of disease etiology, intense competition and a strong emphasis on intellectual property.While we believe that our product candidates and our knowledge and experience provide us with competitive advantages, we face substantial potential competition from many different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions and governmental agencies and public and private research institutions.Many of our current or potential competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical studies, conducting clinical trials and marketing approved products than we do.Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.Accordingly, our competitors may be more successful than we may be in developing, commercializing and achieving widespread market acceptance.In addition, our competitors' products may be more effective or more effectively marketed and sold than any treatment we or our development partners may commercialize and may render our product candidates obsolete or noncompetitive before we can recover the expenses related to developing and commercializing our product candidates.Below is a description of competition in certain of our products and product candidates.With respect to daratumumab, there are numerous other FDA-approved drugs for the treatment of MM, including immunomodulating agents such as Celgene's Revlimid and Pomalyst®; PIs such as Janssen and Takeda's Velcade®, Amgen's Kyprolis®, and Takeda's Ninlaro®; histone deacetylase inhibitors such as Novartis' Farydak®; and mAbs such as BMS' Empliciti™.Several of these drugs are used in combination with chemotherapy and corticosteroids.The competition daratumumab faces from these and other therapies is intensifying.Additionally, Sanofi is conducting several Phase III clinical trials with isatuximab, a CD38 antibody, for the treatment of MM and presented data from its Phase III study of isatuximab in combination with pomalidomide and dexamethasone, or Pom-d, at ASCO in June 2019, reporting that isatuximab improved PFS in patients with R/R MM compared to treatment with Pom-d alone.We are also aware of numerous additional investigational agents that are currently being studied.If any of these investigational agents are successful they may compete with daratumumab in the future.Data have also been presented on several developing technologies and related potential products, including bispecific antibodies, ADCs and CAR-Ts that may compete with daratumumab in the future.Ofatumumab is currently being investigated by Novartis in a low dose subQ formulation for the treatment of RMS in the Phase III ASCLEPIOS I and II clinical studies.Competition in the MS market is intense.There are numerous FDA-approved drugs for the treatment of the various forms of MS, including Biogen Inc.'s Tecfidera®, Novartis' GILENYA®, Sanofi's AUBAGIO® and several mAbs such as Genentech's OCREVUS® (a CD20 antibody), Sanofi's LEMTRADA®, Biogen's TYSABRI®; glatiramer acetate-based therapies such as Teva Pharmaceutical Industries Limited's COPAXONE® and Sandoz's Glatopa®; and interferon-beta-based therapies such as Biogen's AVONEX® and PLEGRIDY®, Bayer AG's BETASERON®/Betaferon®, Novartis' EXTAVIA®, and Merck KGaA's Rebif®.A number of companies are also working to develop additional potential treatments for MS that may in the future further intensify the competition in the MS market, such as Celgene's Ozanimod and Novartis' Siponimod currently being evaluated in Phase III clinical trials.Potential future sales may also be negatively impacted by the introduction of generics, prodrugs of existing therapeutics or biosimilars of existing products and other technologies.With respect to tisotumab vedotin, we are aware of other companies that currently have products in development for the treatment of late-stage cervical cancer which could be competitive with tisotumab vedotin, including checkpoint inhibitors from Agenus Inc., Regeneron Pharmaceuticals Inc., BMS, Merck, Roche, and Innovent Biologics, Inc. as well as other drugs in development from companies such as Immunomedics.In addition, many other pharmaceutical and biotechnology companies are developing and/or marketing therapies for the same types of cancer that our products and product candidates are designed and being developed to treat.We are also aware of other companies that have or are developing technologies that may be competitive with ours, including bispecific antibody, CAR-T and RNA-based technologies.In addition, our DuoBody and other technology partners may develop compounds utilizing our technology that may compete with product candidates that we are developing.In addition, in the United States, the Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" or "biosimilar" to or "interchangeable" with an FDA-approved biological product.This pathway allows competitors to reference the FDA's prior approvals regarding innovative biological products and data submitted with a BLA to obtain approval of a biosimilar application 12 years after the time of approval of the innovative biological product.The 12-year exclusivity period runs from the initial approval of the innovator product and not from approval of a new indication.In addition, the 12-year exclusivity period does not prevent another company from independently developing a product that is highly similar to the innovative product, generating all the data necessary for a full BLA and seeking approval.Data exclusivity only assures that another company cannot rely on the FDA's prior approvals in approving a BLA for an innovator's biological product to support the biosimilar product's approval.Further, under the FDA's current interpretation, it is possible that a biosimilar applicant could obtain approval for one or more of the indications approved for the innovator product by extrapolating clinical data from one indication to support approval for other indications.In the European Union, the European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued since 2005.We are aware of many pharmaceutical and biotechnology companies, as well as other companies that are actively engaged in research and development of biosimilars or interchangeable products.It is possible that our competitors will succeed in developing technologies that are more effective than our products or our product candidates or that would render our technology obsolete or noncompetitive, or will succeed in developing biosimilar or interchangeable products for our products or our product candidates.We anticipate that we will continue to face increasing competition in the future as new companies enter our market and scientific developments surrounding biosimilars and other cancer therapies continue to accelerate.We cannot predict to what extent the entry of biosimilars or other competing products will impact potential future sales of our products or our product candidates.With respect to our current and potential future product candidates, we believe that our ability to compete effectively and develop products that can be manufactured cost-effectively and marketed successfully will depend on our ability to: • advance our products, product candidates and technology platforms; • license additional technology; • complete clinical trials which position our products for regulatory and commercial success; • maintain a proprietary position in our technologies and products; • obtain required government and other public and private approvals on a timely basis; • attract and retain key personnel; • commercialize effectively; • obtain reimbursement for our products in approved indications; • establish efficient manufacturing processes and supply chain; • comply with applicable laws, regulations and regulatory requirements and restrictions with respect to our business, including the commercialization of our products, including with respect to any changed or increased regulatory restrictions; and • enter into additional collaborations to advance the development and commercialization of our product candidates.