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Genmab 2017 Annual Report

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Company Announcement 

Copenhagen, Denmark; February 21, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today its Annual Report for 2017.  Below is a summary of business progress and financial performance for the year, and financial outlook for 2018 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 http://2017overview.genmab.com.

2017 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress   

  • EMA decision & launch in 2nd line + multiple myeloma (MM) relapsed / refractory setting - Achieved

  • FDA decision 3rd line MM setting (daratumumab + pomalidomide) - Achieved

  • Phase III MM interim efficacy analysis in frontline (ALCYONE trial) - Achieved

  • Start Phase III subcutaneous trial - Achieved

  • Start trials in solid tumors and non-MM blood cancers - Achieved

  • Report non-MM clinical data – Expected in 2018

Optimize ofatumumab value

  • Phase III refractory FL headline results – Expected in 2018

Strengthen differentiated product pipeline   

  • Phase I/II tisotumab vedotin data - Achieved

  • Progress HuMax®-AXL-ADC Phase I/II clinical trial - Achieved

  • IND/CTA submission HexaBody®-DR5/DR5 - Achieved

  • IND/CTA submission DuoBody®-CD3xCD20 - Achieved

  • Progress pre-clinical pipeline – Achieved 

Strengthen partnership portfolio with next generation technologies

  • Enter new technology collaborations – Not achieved

  • Progress partnered programs – Achieved 

Disciplined financial management

  • Execute controlled company growth with selective investments in product pipeline – Achieved 

Financial Performance

  • Revenue was DKK 2,365 million in 2017 compared to DKK 1,816 million in 2016. The increase of DKK 549 million, or 30%, was mainly driven by higher DARZALEX® royalties under our daratumumab collaboration with Janssen.

  • Operating expenses increased by DKK 258 million, or 34%, from DKK 763 million in 2016 to DKK 1,021 million in 2017 driven by the advancement of tisotumab vedotin, the addi­tional investment in our product pipeline, and the increase in employees to support the expansion of our pipeline.

  • Operating income was DKK 1,344 million in 2017 compared to DKK 1,053 million in 2016. The improvement of DKK 291 million, or 28%, was driven by higher revenue, which was partly offset by increased operating expenses.

  • 2017 year end cash position of DKK 5,423 million, an increase of DKK 1,501 million, or 38%, from DKK 3,922 million as of December 31, 2016.  

2018 OUTLOOK  

MDKK

2018 Guidance

2017 Actual Result

Revenue

2,700 – 3,100

2,365

Operating expenses

(1,400) – (1,600)

(1,021)

Operating income

1,300 – 1,500

1,344

Revenue

We expect our 2018 revenue to be in the range of DKK 2,700 – 3,100 million, compared to DKK 2,365 million in 2017. Our projected revenue for 2018 consists primarily of DARZALEX royalties of approximately DKK 1,750 million that are based on an estimated USD 2.0 – 2.3 billion of DARZALEX net sales in 2018. We project DARZALEX milestones of approximately DKK 550 million in 2018, consisting primarily of a commercial net sales-based milestone, compared to DKK 1,109 million in 2017. In addition, the 2018 guidance includes the one-time payment from Novartis of approximately DKK 300 million related to the transition of Arzerra® from commercial availability to compassionate use programs in non-US markets. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.   

The overall increase in revenue compared to 2017 is primarily due to a one-time payment from Novartis combined with higher DARZALEX royalties which were partly offset by a decrease in DARZALEX milestones.

Operating Result

We anticipate that our 2018 operating expenses will be in the range of DKK 1,400 – 1,600 million, compared to 2017 operating expenses of DKK 1,021 million. The increase is driven by the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and an increase in employees to support the expansion of our product pipeline.   

We expect the operating income for 2018 to be approximately DKK 1,300 – 1,500 million compared to DKK 1,344 million reported for 2017. 

More information on the Risks and Assumptions for the 2018 Financial Guidance can be found in the 2017 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 2017 today, February 21, 2018 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call by phone, dial one of the following numbers and ask for the Genmab conference call: 

US: + 1 646 828 8156

UK: + 44 330 336 9411

DK: + 45 35 15 81 21

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: 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®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

Company Announcement no. 05

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Vedhæftet fil: 05_Genmab_AR17_210218.pdf

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