May 7, 2014; Copenhagen, Denmark;
Interim Report First Quarter 2014
- Arzerra® (ofatumumab) was approved by the FDA in combination with chlorambucil for previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate
- Achieved USD 22 million milestone payment under Janssen Biotech, Inc. collaboration for daratumumab
- Announced two Phase III studies for daratumumab in multiple myeloma
- Successful international equity private placement
- Improved operating result by DKK 67 million over first quarter 2013
- Original guidance improved
“During the first quarter, we made substantial progress towards meeting our 2014 goals. We successfully launched a private placement, bringing DKK 972 million into the company and further strengthening our financial position. We made significant progress in our daratumumab collaboration with Janssen, as we announced two Phase III studies in our broad and robust development program and reached a USD 22 million milestone based on progress in an ongoing Phase II study. In April we were also very pleased that the US regulatory authorities approved an additional indication for Arzerra in combination with chlorambucil to treat CLL patients in the first-line setting. We look forward to further data readouts this year from ongoing Phase III studies with ofatumumab which could lead to other potential regulatory applications to expand the label,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
- Genmab’s revenue increased DKK 87 million or 55% to DKK 247 million in the first quarter of 2014. The increase was mainly driven by higher revenue related to our daratumumab collaboration with Janssen.
- Operating expenses were DKK 151 million in the first quarter of 2014, compared to DKK 131 million in the first quarter of 2013. The increase of DKK 20 million or 15% was primarily related to an increased investment in daratumumab and in our other research programs, partly offset by a decrease in costs associated with the ofatumumab program.
- Operating income was DKK 96 million in the first quarter of 2014 compared to an operating income of DKK 29 million in the corresponding period for 2013, an improvement of DKK 67 million, which was driven by increased revenue, partly offset by the increase in operating expenses.
- On March 31, 2014, Genmab had a cash position of DKK 2,530 million. This represented a net increase of DKK 973 million from the beginning of 2014. The increase was driven by the net proceeds of DKK 972 million received from the private placement in January 2014.
Business Progress First Quarter to Present
- May: A Phase III study investigating daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma was announced. 2014 guidance improved due to the inclusion of an anticipated milestone related to this Phase III study.
- April: The US FDA approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
- April: GlaxoSmithKline (GSK) reported net sales for Arzerra for the first quarter of 2014 of GBP 15.6 million, resulting in royalty income of approximately DKK 28 million to Genmab. The first quarter 2014 net sales did not include sales related to the supply of ofatumumab for clinical trials run by other parties. Sales in the first quarter of 2013 were impacted by clinical trial supply sales.
- March: A USD 22 million (DKK 119 million) milestone payment to Genmab was triggered by progress in the ongoing Phase II study of daratumumab in double refractory multiple myeloma under the collaboration with Janssen.
- March: A Phase III study investigating daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma was announced.
- January: Raised net proceeds of DKK 972 million following a private placement of 4.6 million new shares in the company.
- January: Announced a research collaboration with Eli Lilly and Company to use and evaluate the DuoBody technology platform.
Outlook Genmab is maintaining the improved 2014 financial guidance published on May 1, 2014.
Conference Call Genmab will hold a conference call in English to discuss the results for the first quarter of 2014 today, Wednesday, May 7, 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 .
About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications, a clinical pipeline with both late and early stage programs, and an innovative pre-clinical 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. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab’s strategy and the company 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 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 this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this 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 TM and UniBody ® . Arzerra ® is a registered trademark of the GlaxoSmithKline group of companies.
Company Announcement no. 22 CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark
