November 14, 2018; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2018
Highlights
- USD 1,441 million in net sales of DARZALEX® (daratumumab), resulting in royalty income of DKK 1,111 million
- DARZALEX approved in Europe in combination with bortezomib, melphalan and prednisone (VMP) for frontline multiple myeloma, triggering USD 13 million milestone payment from Janssen
- Entered strategic collaboration with Immatics to discover and develop next-generation bispecific cancer immunotherapies
“During the third quarter, Genmab continued to push ahead towards completing our goals for 2018. This quarter’s highlights included the European approval of DARZALEX in combination with other standard therapies for the treatment of frontline multiple myeloma and the strategic collaboration we signed with Immatics to fuel the growth of Genmab’s innovative immunotherapy pipeline in the future,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2018
- Revenue was DKK 1,789 million in the first nine months of 2018 compared to DKK 1,348 million in the first nine months of 2017. The increase of DKK 441 million, or 33%, was mainly driven by higher DARZALEX royalties, the payment from Novartis of USD 50 million and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by a decrease in DARZALEX milestones.
- Operating expenses were DKK 1,130 million in the first nine months of 2018 compared to DKK 707 million in the first nine months of 2017. The increase of DKK 423 million, or 60%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
- Operating income was DKK 659 million in the first nine months of 2018 compared to DKK 641 million in the first nine months of 2017. The increase of DKK 18 million, or 3%, was driven by higher revenue, which was offset by increased operating expenses.
Subsequent Events
- October: The Phase III CASSIOPEIA study (MMY3006) of daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) versus VTD alone as frontline treatment for multiple myeloma patients who are candidates for autologous stem cell transplant (ASCT) met its primary endpoint of number of patients that achieved a stringent Complete Response (sCR), which was reported in 28.9% of patients treated with daratumumab in combination with VTD, compared to 20.3% of patients who received VTD alone with an odds ratio of 1.60 (95% CI: 1.21 – 2.12, p ≤ 0.001). The safety profile of daratumumab in combination with VTD is consistent with the known safety profile of the VTD regimen used in patients receiving ASCT and the known safety profile for daratumumab.
- October: The Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and ASCT met its primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p < 0.0001), resulting in a 45% reduction in the risk of progression or death in patients treated with DRd. The median PFS for patients treated with DRd has not been reached, compared to an estimated median PFS of 31.9 months for patients who received Rd alone. Overall, the safety profile of daratumumab in combination with Rd is consistent with both the known safety profiles of the Rd regimen and daratumumab.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2018 today, Wednesday, November 14, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EST. To join the call dial
+1 646 828 8193 (US participants) or +44 330 336 9411 (international participants) and provide conference code 4314747.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; E: rcg@genmab.com
The interim report 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 product discovery and development, 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 section “Risk Management” in Genmab’s annual report, which is available on www.genmab.com and the “Significant Risks and Uncertainties” section in the interim report. Genmab does not undertake any obligation to update or revise forward looking statements in the interim report nor to confirm such statements 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 Biotech, Inc.
Download the full Interim Report for the Nine Months Ended September 30, 2018 on attachment or at www.genmab.com.
Company Announcement no. 33
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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