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Genmab 2016 Annual Report

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Company Announcement

Copenhagen, Denmark; February 22, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today its Annual Report for 2016.  Below is a summary of business progress and financial performance for the year, and financial outlook for 2017 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.

2016 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

  • Launch DARZALEX in US and other approved territories - Achieved

  • CHMP decision on monotherapy application - Achieved

  • Phase III multiple myeloma (MM) interim efficacy analysis in relapsed / refractory MM settings [POLLUX and CASTOR trials] - Achieved

  • File for label in relapsed / refractory settings if results of interim analyses are favorable - Achieved

  • Start multiple clinical trials in MM and non-MM indications - Achieved

  • Report initial clinical data non-MM indications – Clinical data from a non-MM indication for daratumumab is anticipated in 2017.

Optimize ofatumumab value

  • Start Phase III subcutaneous autoimmune trials - Achieved

  • Regulatory decision for CLL maintenance - Achieved

  • File for label in relapsed CLL - Achieved

  • Phase III refractory follicular lymphoma (FL) interim efficacy data – Study continued at interim analysis. Full data expected 2017.

Strengthen differentiated product pipeline

  • Phase I/II tisotumab vedotin additional data - Achieved

  • IND for HuMax-AXL-ADC and start clinical trial - Achieved

  • Progress HexaBody-DR5/DR5 program - Achieved

  • Progress pre-clinical DuoBody & HexaBody projects - Achieved

Broaden partnership portfolio with next generation technologies

  • Sign new / expanded DuoBody & HexaBody collaborations – Goal was to sign two or more commercial collaborations; partially achieved goal with one commercial agreement for DuoBody technology with Gilead Sciences.

  • Progress partnered programs - Achieved

  • New IND filings – Achieved

Disciplined financial management

  • Selectively invest to progress and broaden differentiated product pipeline - Achieved

Financial Performance

  • Revenue was DKK 1,816 million in 2016 compared to DKK 1,133 million in 2015. The increase of DKK 683 million, or 60%, was mainly driven by higher milestone and royalty revenue under our daratumumab collaboration with Janssen, partly offset by a decrease in our deferred revenue.

  • Operating expenses increased by DKK 184 million, or 32%, from DKK 579 million in 2015 to DKK 763 million in 2016 driven by the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our early stage pre-clinical programs.

  • Operating income was DKK 1,053 million in 2016 compared to DKK 730 million in 2015. The improvement of DKK 323 million, or 44%, was driven by higher revenue, which was partly offset by increased operating expenses in 2016 and the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015.

  • 2016 year end cash position of DKK 3,922 million, an increase of DKK 429 million, or 12%, from DKK 3,493 million as of December 31, 2015.

     

2017 OUTLOOK

MDKK

2017 Guidance

2016 Actual Result

Revenue

1,950 – 2,150

1,816

Operating expenses

(1,000) – (1,100)

(763)

Operating income

900 – 1,100

1,053

Cash position at end of year*

> 4,500

3,922

*Cash, cash equivalents, and marketable securities

 

Conference Call

Genmab will hold a conference call in English to discuss the results for the full year 2016 today, February 22, at 6.00 pm CET, 5.00 pm GMT or noon EST. The dial in numbers are:

 

+1 646 254 3363 (US participants) and ask for the Genmab conference call

+44 20 3427 1912 (international participants) and ask for the Genmab conference call

 

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, other blood cancers, and solid tumors.  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, and the HexaBody® platform which creates effector function enhanced antibodies.  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; M: +45 25 12 62 60; E: r.gravesen@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 in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX™ is a trademark of Janssen Biotech, Inc.

 

Company Announcement no. 06

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Bredgade 34E

1260 Copenhagen K

Denmark

Vedhæftet fil: 06 Genmab_AR16_220217.pdf

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