November 6, 2013; Copenhagen, Denmark;
Interim Report the Nine Months Ended September 30, 2013
- Applications to expand Arzerra® (ofatumumab) label submitted in US & EU
- Received Breakthrough Therapy Designation for ofatumumab
- Sales of Arzerra in first nine months increased 23% over prior year
- Improved operating result by DKK 125 million over nine months 2012
- Guidance maintained
“Throughout the year Genmab has consistently delivered on the goals we communicated to the market. We’ve reported positive data on ofatumumab, started a new study with daratumumab, are set to start the first clinical trial with HuMax-TF-ADC, have filed applications to expand the label and access to ofatumumab, and have delivered positive financial results. We’re also proud to be among a select few companies who have received Breakthrough Therapy Designations for two products and believe this accomplishment is reflective of the leading-edge innovation that is at the heart of Genmab,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months
- Genmab’s revenue was DKK 448 million for the first nine months of 2013 compared to DKK 322 million for the corresponding period in 2012. The increase of DKK 126 million or 39% was mainly driven by higher revenue related to our daratumumab and DuoBody collaborations with Janssen as well as to Arzerra royalties.
- Operating expenses were virtually flat at DKK 432 million in the first nine months of 2013, compared to DKK 430 million in the first nine months of 2012.
- Operating income was DKK 16 million in the first nine months of 2013 compared to an operating loss of DKK 109 million in the corresponding period for 2012, an improvement of DKK 125 million, which was primarily driven by increased revenue.
- The net result for discontinued operation amounted to a net income of DKK 42 million in the first nine months of 2013. The net income in 2013 related to the final few months of running costs of the Minnesota manufacturing facility of DKK 10 million prior to its divestiture and a gain on the sale of DKK 52 million. The facility maintenance cost amounted to DKK 31 million in the first nine months of 2012.
- On September 30, 2013, Genmab had a cash position of DKK 1,498 million. This represented a net decrease of DKK 18 million from the beginning of 2013 which related to the ongoing operating activities, partially offset by the proceeds received from the sale of the manufacturing facility and the exercise of warrants in the first nine months of 2013.
Business Progress Third Quarter to Present
- October: GSK reported net sales for Arzerra for the third quarter of 2013 of GBP 17.8 million, resulting in royalty income of DKK 31 million to Genmab.
- October: Genmab and GSK submitted a supplemental Biologics License Application (sBLA) to the US FDA to expand the label of Arzerra to include use of Arzerra in combination with an alkylator-based therapy for the treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
- October: Genmab and GSK submitted an application (a variation to the Marketing Authorization) to broaden the label for Arzerra to include use of Arzerra in combination with an alkylator-based therapy for the treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy to the European Medicines Agency (EMA).
- October: Positive top-line data from a Phase II study of subcutaneous ofatumumab in RRMS was reported. The results showed a clear separation from placebo on the cumulative number of new gadolinium enhancing lesions (active brain lesions) over a period of 12 weeks in patients treated with all doses of ofatumumab compared to patients treated with placebo.
- September: The US FDA granted Breakthrough Therapy designation for Arzerra in combination with chlorambucil for the treatment of patients with CLL who have not received prior treatment and are inappropriate for fludarabine-based therapy.
- September: Announced that Janssen will start a new Phase II study of daratumumab in multiple myeloma patients who have received at least three different lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD.
- August: Reached a technical proof-of-concept milestone in the DuoBody collaboration with Janssen, triggering a milestone payment to Genmab of USD 1 million.
- July: Filed an Investigational New Drug application (IND) with the US FDA for HuMax®-TF-ADC in solid tumors.
- July: Announced a Phase III study of ofatumumab, given subcutaneously to treat pemphigus vulgaris (PV) a rare autoimmune disorder of the skin, run by GSK.
- July: In April, the US Court of Appeals for the Federal Circuit upheld the US District Court's judgment in favor of GSK in a patent infringement case involving Arzerra brought against GSK by Genentech and Biogen Idec. A request for a re-hearing was filed by Genentech and Biogen Idec in May and subsequently refused by the US Court of Appeals in July. This decision is now final as Genentech and Biogen Idec have not requested further review by the Supreme Court.
Outlook
Genmab is maintaining the 2013 financial guidance published on August 14, 2013.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2013 today, Wednesday, November 6, at 6.00 pm CET, 5.00 pm GMT or noon EST. 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
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 logoTM; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of GlaxoSmithKline.
Company Announcement no. 46
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
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