May 12, 2015; Copenhagen, Denmark; Interim Report First Quarter 2015
- Positive preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma
- Positive top-line results from the Phase III COMPLEMENT 2 study of Arzerra ® plus fludarabine and cyclophosphamide in relapsed CLL
- Entered DuoBody ® platform collaboration with BioNovion and acquired antibody assets from iDD Biotech
- Transfer of the ofatumumab collaboration from GlaxoSmithKline (GSK) to Novartis became effective
- Improved operating result by DKK 77 million over first quarter 2014
“We have already announced significant achievements during the first quarter this year. We were very encouraged by the positive preliminary data in the Phase II study of daratumumab in double refractory multiple myeloma. The transfer of the ofatumumab agreement from GSK to Novartis was successfully completed and we are already working with Novartis on the future of the ofatumumab development program in cancer indications. We also announced the first technology collaboration agreement of the year, under which we will work together with BioNovion on DuoBody platform products in immuno-oncology. Additionally, we added a new pre-clinical program to our pipeline with the acquisition of antibodies directed to DR5 from iDD Biotech,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
- Genmab’s revenue was DKK 107 million in the first quarter of 2015, compared to DKK 247 million in the first quarter of 2014. The decrease of DKK 140 million or 57% was mainly driven by lower milestone revenue under our daratumumab collaboration with Janssen.
- Operating expenses were DKK 110 million in the first quarter of 2015, compared to DKK 151 million in the first quarter of 2014. The decrease of DKK 41 million or 27% was primarily related to a decrease in costs associated with the ofatumumab and daratumumab programs, which was partly offset by increased investment in our research and technology platforms.
- Operating income was DKK 173 million in the first quarter of 2015 compared to DKK 96 million in the corresponding period for 2014. The improvement of DKK 77 million was driven by the income from reversal of the ofatumumab funding liability of DKK 176 million, which was partly offset by decreased revenue.
- On March 31, 2015, Genmab had a cash position of DKK 2,945 million. This represented a net increase of DKK 285 million from the beginning of 2015, which was driven primarily by the proceeds from exercise of warrants of DKK 317 million partly offset by the ongoing investment in our research and development activities.
Business Progress First Quarter to Present
- May: Announced net sales of Arzerra by GSK & Novartis for the first quarter of 2015 of GBP 11.1 million, resulting in royalty income of approximately DKK 22 million to Genmab.
- April: Announced positive top-line results from the Phase III COMPLEMENT 2 study which showed that treatment with Arzerra plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (p = 0.0036) compared to those given fludarabine and cyclophosphamide alone. The data will be shared with the US and EU regulatory agencies to evaluate the potential for future regulatory filings.
- April: Achieved a USD 10 million milestone payment in the daratumumab collaboration with Janssen Biotech, Inc. for progress in the ongoing Phase III study (“Alcyone” MMY3007) which compares daratumumab in combination with bortezomib, melphalan and prednisone (VMP) to VMP alone as front line treatment for multiple myeloma patients who are not considered candidates for stem cell transplantation.
- March: Announced an agreement to purchase antibodies and related patents and know-how from iDD Biotech SAS.
- March: Announced the decision not to exercise co-development right for HuMax ® -TAC-ADC under our agreement with ADC Therapeutics Sarl. Genmab will retain 25% of the rights to the product.
- March: Announced the agreement to transfer the ofatumumab collaboration from GSK to Novartis became effective. As a result of the transfer, Genmab is not liable for any ofatumumab development costs in 2015 and beyond, and is not required to pay the existing deferred funding liability of DKK 176 million. GSK licensed the rights to continue development of ofatumumab in autoimmune indications from Novartis.
- February: Entered a co-development and commercialization agreement with BioNovion to evaluate a number of DuoBody product candidates targeting immune checkpoints.
- February: Announced preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma. The data are being discussed with the health authorities.
Outlook Genmab is maintaining its updated 2015 financial guidance published on March 11, 2015.
Conference Call Genmab will hold a conference call in English to discuss the results for the first quarter of 2015 today, Tuesday, May 12, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:
+1 866 682 8490 (US participants) and ask for the Genmab conference call +44 1452 555 131 (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 .
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 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 its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo TM ; the DuoBody logo ® ; the HexaBody™ logo; HuMax ® ; HuMax-CD20 ® ; DuoBody ® , HexaBody ® and UniBody ® . Arzerra ® is trademark of Novartis Pharma AG. CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark Download the full Interim Report for the First Quarter of 2015 on attachment or at www.genmab.com .
