On February 19, 2020 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2019 (Press release, Genmab, FEB 19, 2020, View Source [SID1234554499]). Below is a summary of business progress in 2019, financial performance for the year and the financial outlook for 2020. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source
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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2019 today, February 19, 2020 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 4887886.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
2019 ACHIEVEMENTS
Business Progress
Daratumumab
U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission – achieved
U.S. FDA decision on Phase III CASSIOPEIA MM submission – achieved
Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis – achieved
Ofatumumab
·Phase III ASCLEPIOS I & II relapsing multiple sclerosis SubQ ofatumumab study completion and reporting – achieved
Tisotumab vedotin
·Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study enrollment complete by mid-year – achieved
Innovative Pipeline
Phase II enapotamab vedotin expansion cohort efficacy analysis – achieved
Phase I/II HexaBody-DR5/DR5 initial clinical data – initial data now anticipated in 2020
Phase I/II epcoritamab (DuoBody-CD3xCD20) clinical data dose escalation cohorts – achieved
File INDs and/or CTAs for 3 new product candidates – achieved
U.S. IPO
Genmab successfully completed an initial public offering (IPO) of American Depositary Shares (ADSs) on the Nasdaq Global Select Market
Achievement made Genmab a dual-listed company listed on both the Nasdaq Copenhagen in Denmark and the Nasdaq Global Select Market in the U.S.
Financial Performance
Revenue was DKK 5,366 million in 2019 compared to DKK 3,025 million in 2018. The increase of DKK 2,341 million, or 77%, was mainly driven by higher DARZALEX royalties and milestones achieved under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 1,083 million, or 66%, from DKK 1,645 million in 2018 to DKK 2,728 million in 2019 driven by the advancement of tisotumab vedotin and enapotamab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 2,638 million in 2019 compared to DKK 1,380 million in 2018. The improvement of DKK 1,258 million, or 91%, was driven by higher revenue, which was partly offset by increased operating expenses.
2019 year-end cash position of DKK 10,971 million, an increase of DKK 4,865 million, or 80%, from DKK 6,106 million as of December 31, 2018.
2020 OUTLOOK
Revenue
We expect our 2020 revenue to be in the range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million in 2019. Our revenue in 2019 included DKK 1,684 million related to one-time sales milestones for DARZALEX net sales exceeding USD 2.5 billion and 3.0 billion in a calendar year.
Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 – 4,475 million. Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019. Such royalties are based on estimated DARZALEX net sales of USD 3.9 – 4.2 billion. We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties.
Operating Expenses
We anticipate our 2020 operating expenses to be in the range of DKK 3,850 – 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3x-CD20) and DuoBody-PD-L1x4-1BB.
Operating Result
We expect our operating income to be in the range of DKK 850 – 1,250 million in 2020 compared to DKK 2,638 million in 2019.