August 14, 2013; Copenhagen, Denmark;
Interim Report First Half 2013
Reported positive top line results in Phase III study of ofatumumab in previously untreated chronic lymphocytic leukemia (CLL)
Received Breakthrough Therapy Designation for daratumumab
First half net sales of Arzerra® increased 40% over prior year
Improved operating result by DKK 93 million over H1 2012
Improved guidance and year-end cash balance
“The strength and value of our pipeline is becoming very clear as we achieve our goals with ofatumumab and daratumumab. We reported two strong sets of data on ofatumumab in chronic lymphocytic leukemia during the second quarter which show the future promise of this therapy. We were also very pleased that daratumumab was awarded Breakthrough Therapy Designation by the FDA, which we hope will expedite bringing this treatment to the market. These achievements, together with our improved financial guidance, continue to move Genmab forward to our goal of becoming sustainably profitable,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
Genmab’s revenue was DKK 298 million for the first half of 2013 compared to DKK 206 million for the corresponding period in 2012. The increase of DKK 92 million or 45% was mainly driven by revenue related to our daratumumab collaboration with Janssen Biotech (Janssen) as well as higher Arzerra royalties.
Operating expenses were unchanged at DKK 287 million compared to the first half of 2012.
Operating income was DKK 11 million in the first half of 2013 compared to an operating loss of DKK 82 million in the corresponding period for 2012, an improvement of DKK 93 million. The improved operating result was driven by increased revenue and continued strong focus on cost control.
The net result for discontinued operation amounted to a net income of DKK 42 million in the first half 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 20 million in the first half of 2012.
On June 30, 2013, Genmab had a cash position of DKK 1,547 million. This represented a net increase of DKK 31 million from the beginning of 2013 which was primarily related to proceeds from the sale of the manufacturing facility and proceeds from the exercise of warrants in the first half of 2013, partially offset by the ongoing investment in our research and development activities. The cash burn for the first half of 2012 was DKK 153 million.
Business Progress Second Quarter to Present
April & May: The US Food and Drug Administration (FDA) granted Breakthrough Therapy, Fast Track and Orphan Drug Designations for daratumumab. The designations cover patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or are double refractory to a PI and an IMiD.
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.
May: Reported positive top line data from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed CLL. The overall response rate (ORR) in the study was 95% in previously untreated patients and 74% in patients with relapsed CLL.
May: Reported positive top line results from a Phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in patients with previously untreated CLL. A 9.3 month improvement in median progression free survival (PFS) was seen in patients who received ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
May: Launched Sponsored Level 1 American Depositary Receipt (ADR Program) under the ticker symbol GMXAY.
June: Phase II development of teprotumumab (RG1507, an antibody created by Genmab in collaboration with Roche) in active thyroid eye disease was restarted by River Vision Development Corporation, who licensed the product from Roche.
July: A Phase III study of ofatumumab given subcutaneously to treat pemphigus vulgaris (PV), a rare autoimmune disorder of the skin, is being started by GSK.
July: Filed an Investigational New Drug application (IND) with the US FDA for HuMax®-TF-ADC in solid tumors.
July: GSK reported net sales for Arzerra for the second quarter of 2013 of GBP 17.8 million, an increase of 19% over Q2 2012, resulting in royalty income of DKK 31 million to Genmab.
Genmab is improving its 2013 financial guidance as announced on March 7, 2013.
Genmab will hold a conference call in English to discuss the results for the first half of 2013 today, Wednesday, August 14, 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.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: firstname.lastname@example.org
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™; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of GlaxoSmithKline.
Company Announcement no. 34
CVR no. 2102 3884
1260 Copenhagen K