COPENHAGEN, Denmark, Aug. 12, 2015 (GLOBE NEWSWIRE) -- Interim Report First Half 2015
- Rolling submission of BLA to U.S. FDA for daratumumab in double refractory multiple myeloma completed by Janssen, triggering a USD 15 million milestone payment
- Regulatory submissions for ofatumumab (Arzerra®) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA
- Achieved USD 10 million milestone payment under daratumumab collaboration with Janssen for progress in Phase III study ("Alcyone" MMY3007)
- Positive top-line results from the Phase III COMPLEMENT 2 study of ofatumumab plus fludarabine and cyclophosphamide in relapsed CLL
- Entered commercial agreement for DuoBody® platform with BioNTech in the field of immuno-oncology
- Improved operating result by DKK 147 million over the first half of 2014
"During the second quarter we continued to see steady advances in our two most advanced programs, daratumumab and ofatumumab. The daratumumab program continues to progress very rapidly with the first regulatory application submitted in the U.S. by Janssen Biotech, Inc. under our collaboration. Together with Novartis, we reported positive top-line results in a pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL; the data will be shared with the regulatory authorities to determine the potential for regulatory filings. Regulatory submissions for ofatumumab as maintenance therapy in relapsed CLL were submitted by Novartis to the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in July. We also continue to focus on our technologies and effectively progress a robust early stage pipeline, having entered an agreement with BioNTech for the DuoBody platform in the field of immuno-oncology and obtaining a license from Bristol-Myers Squibb for antibodies targeting CD19," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
- Revenue was DKK 281 million in the first half of 2015 compared to DKK 363 million in the first half of 2014. The decrease of DKK 82 million or 23% was mainly driven by lower milestone revenue under our daratumumab collaboration with Janssen.
- Operating expenses were DKK 244 million in the first half of 2015 compared to DKK 298 million in the first half of 2014. The decrease of DKK 54 million or 18% 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 212 million in the first half of 2015 compared to DKK 65 million in the first half of 2014. The improvement of DKK 147 million was driven by the income from reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.
- On June 30, 2015, Genmab had a cash position of DKK 2,958 million. This represented a net increase of DKK 297 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 478 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.
Business Progress Second Quarter to Present
- July: The rolling submission of a Biologics License Application (BLA) to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab. The initiation of the rolling submission was announced in June. (Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab in 2012.)
- July: Announced that regulatory applications were submitted to the EMA and FDA for the use of ofatumumab as maintenance therapy of patients with relapsed CLL by Novartis.
- June: Entered an agreement for an exclusive license from Bristol-Myers Squibb to a panel of human antibodies targeting CD19.
- May: Entered an agreement with BioNTech AG to jointly research, develop and commercialize bispecific antibody products within the field of immuno-oncology using the DuoBody technology platform.
- May: Presented first preliminary clinical data from the ongoing Phase I study of HuMax®-TF-ADC in solid tumors, showing that HuMax-TF-ADC can be dosed safely in therapeutically meaningful doses and with encouraging early signs of efficacy.
- 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 (HR 0.67, p = 0.0032) 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 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.
Genmab is maintaining its updated 2015 financial guidance published on May 20, 2015.
Genmab will hold a conference call in English to discuss the results for the first half of 2015 today, Tuesday, August 11, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:
+1 646 254 3363 (US participants) and ask for the Genmab conference call
+44 20 3427 1914 (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
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™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis Pharma AG.
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Download the full Interim Report for the first half of 2015 on attachment or at www.genmab.com.