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20-02-2019 12:18:07

Genmab 2018 Annual Report

Company Announcement

Copenhagen, Denmark; February 20, 2019 –

Genmab A/S (Nasdaq Copenhagen: GEN) announced today its Annual Report for 2018.  Below is a summary of business progress and financial performance for the year, and financial outlook for 2019 from the report. 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 https://2018overview.genmab.com.

2018 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

  • FDA and EMA decision on Phase III ALCYONE multiple myeloma (MM) submission - Achieved
  • Start new Phase III MM study - Achieved
  • Report early clinical data in solid tumors – Not achieved
  • Phase III MAIA MM efficacy analysis in frontline - Achieved
  • Phase III CASSIOPEIA MM efficacy analysis in frontline - Achieved

Optimize ofatumumab value

  • Complete recruitment Phase III subcutaneous ofatumumab relapsing MS studies – Achieved

Maximize tisotumab vedotin progress

  • Start two Phase II studies in cervical cancer (recurrent / metastatic & combination study in frontline) – One Phase II study with tisotumab vedotin in cervical cancer was started in 2018. A Phase I/II study in cervical cancer was posted on www.clinicaltrials.gov in 2018, but had not started before year end.
  • Start Phase II study in additional solid tumor indications - Achieved

Strengthen differentiated product pipeline and technology partnership portfolio

  • Start HuMax-AXL-ADC expansion phase in ongoing Phase I/II study - Achieved
  • Progress HexaBody-DR5/DR5 Phase I/II study - Achieved
  • Progress DuoBody-CD3xCD20 Phase I/II study - Achieved
  • Accelerate proprietary Immuno-Oncology DuoBody programs towards clinic - Achieved
  • Enter new technology or product collaborations – Genmab entered one new technology collaboration, with Immatics, during 2018.

             

Disciplined financial management and building a commercial footprint

  • Execute controlled company growth with selective investments in product & technology pipeline – Achieved
  • Continue investing in building commercialization and launch capabilities

Financial Performance

  • Revenue was DKK 3,025 million in 2018 compared to DKK 2,365 million in 2017. The increase of DKK 660 million, or 28%, was mainly driven by higher DARZALEX royalties under our daratumumab collaboration with Janssen, the payment from Novartis of USD 50 million (DKK 304 million) and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by a decrease in DARZALEX milestones.
  • Operating expenses increased by DKK 624 million, or 61%, from DKK 1,021 million in 2017 to DKK 1,645 million in 2018 driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support the expansion of our pipeline.
  • Operating income was DKK 1,380 million in 2018 compared to DKK 1,344 million in 2017. The improvement of DKK 36 million, or 3%, was driven by higher revenue, which was mostly offset by increased operating expenses.
  • 2018 year end cash position of DKK 6,106 million, an increase of DKK 683 million, or 13%, from DKK 5,423 million as of December 31, 2017.

             

2018 OUTLOOK

MDKK

2019 Guidance

2018 Actual Result

Revenue4,600 3,025 
Operating expenses(2,600)(1,645)
Operating income2,000 1,380 

Revenue

We expect our 2019 revenue to be approximately DKK 4,600 million, compared to DKK 3,025 million in 2018, an increase of DKK 1,575 million or 52%.  Our projected revenue for 2019 primarily consists of DARZALEX royalties of DKK 2,685 million, based on estimated net sales of USD 3.0 billion. We project DARZALEX milestones of approximately DKK 1,500 million related to commercial net-sales based milestones for achieving net-sales in a calendar year of both USD 2.5 billion and USD 3.0 billion respectively. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.

Operating Expenses

We anticipate that our 2019 operating expenses will be approximately DKK 2,600 million, an increase of DKK 955 million or 58% compared to 2018. The increase is driven by the advancement of our clinical programs, particularly tisotumab vedotin and enapotamab vedotin.

Operating Result

We expect the operating income to be approximately DKK 2,000 million in 2019 compared to DKK 1,380 million in 2018, an increase of DKK 620 million or 45%.

More information on the Risks and Assumptions for the 2019 Financial Guidance can be found in the 2018 Annual Report available on our website www.genmab.com.

Conference Call

Genmab will hold a conference call in English to discuss the results for the full year results for 2018 today, February 20, 2019 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call dial +1 866 966 1396 (US participants) or +44 2071 928000 (international participants) and provide conference code 8793105.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

About Genmab

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications and other blood cancers.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies and the HexElect™ platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products.  Genmab has alliances with top tier pharmaceutical and biotechnology companies.    For more information visit www.genmab.com.

Contact:          

Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications

T: +45 33 44 77 20 E: rcg@genmab.com

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, 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. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody™; HexElect™; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

Company Announcement no. 07

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

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