COPENHAGEN, Denmark, May 7, 2013 (GLOBE NEWSWIRE) -- Interim Report First Quarter 2013
- Arzerra(r) received approval in Japan
- Arzerra net sales increased 65% over Q1 2012
- Manufacturing facility sold to Baxter
- Improved operating result by DKK 73 million over Q1 2012
"We expect 2013 to be another exciting and productive year at Genmab and are working hard to fulfill the objectives we set for this year. We were pleased to gain approval for Arzerra in Japan, the first Asian territory to give marketing authorization to the product, as well as to see growing sales during Q1. We recently reported impressive top line results from a Phase II study using ofatumumab together with bendamustine to treat CLL patients and look forward to reporting important Phase III data from our frontline CLL study with ofatumumab in the coming time," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
- Genmab's revenue was DKK 160 million for the first quarter of 2013 compared to DKK 94 million for the corresponding period in 2012. The increase of DKK 66 million or 70% was mainly driven by higher Arzerra royalties, revenue related to our daratumumab collaboration with Janssen Biotech (Janssen) and the achievement of a milestone under our collaboration with GlaxoSmithKline (GSK).
- Operating expenses decreased 5% from DKK 138 million in the first quarter of 2012 to DKK 131 million in the first quarter of 2013.
- Operating income was DKK 29 million in the first quarter of 2013 compared to an operating loss of DKK 44 million in the corresponding period for 2012, an improvement of DKK 73 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 quarter 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 10 million in the first quarter of 2012.
- On March 31, 2013, Genmab had a cash position of DKK 1,554 million. This represented a net increase of DKK 38 million from the beginning of 2013, which was primarily related to proceeds received from the sale of the manufacturing facility. The cash burn for the first quarter of 2012 was DKK 74 million.
Business Progress First Quarter to Present
- February: The Minnesota manufacturing facility was sold to Baxter Healthcare (Baxter) Corporation for USD 10 million.
- March: Arzerra received approval in Japan for use in patients with relapsed/refractory CD20-positive chronic lymphocytic leukemia (CLL). The approval triggered a milestone payment of DKK 20 million from GSK to Genmab.
- April: The US Food and Drug Administration (FDA) granted Fast Track designation for daratumumab. This designation covers 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: GSK reported net sales for Arzerra for the first quarter of 2013 of GBP 20.5 million, an increase of 65% over Q1 2012, resulting in royalty income of DKK 36 million to Genmab. A large portion of the rest of the world sales in the first quarter of 2013 were related to the supply of ofatumumab for clinical trials run by other companies, and as such does not reflect ongoing commercial demand.
- April: The U.S. Court of Appeals for the Federal Circuit upheld the U.S. District Court's judgment in favor of GSK in a patent infringement case involving Arzerra brought against GSK by Genentech and Biogen Idec.
- May: Reported impressive 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: The US FDA granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD or who are refractory to a PI and an IMiD.
Genmab is maintaining 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 quarter of 2013 today, Tuesday, 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's first marketed antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of 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.
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(r); the Y-shaped Genmab logo(r); the DuoBody logo(r); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(tm) and UniBody(r)are all trademarks of Genmab A/S. Arzerra(r) is a trademark of GlaxoSmithKline.
Company Announcement no. 20
CVR no. 2102 3884
1260 Copenhagen K
CONTACT: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60 E: email@example.comSource:Genmab A/S