November 5, 2014; Copenhagen, Denmark;
Interim Report for the Nine Months Ended September 30, 2014
- Announced two new Phase III studies of daratumumab in multiple myeloma
- Achieved USD 25 million and USD 10 million milestone payments under Janssen Biotech, Inc. collaboration for daratumumab
- Entered into an agreement with GSK and Novartis, transferring ofatumumab collaboration with GSK to Novartis, conditional on the satisfaction of certain conditions
- Arzerra® (ofatumumab) launch in US and label expansion in EU for first-line chronic lymphocytic leukemia (CLL)
- Phase III PROLONG study of ofatumumab maintenance therapy in relapsed CLL met primary endpoint at interim analysis
- Announced new antibody-drug conjugate (ADC) collaboration with Seattle Genetics for HuMax®-AXL
- Improved first nine month operating income by DKK 188 million over 2013
“The third quarter was solid from both a financial and clinical development perspective. Operating income increased through significant revenue growth combined with our disciplined financial management which kept our operating expenses flat year over year. The daratumumab program is making excellent progress with two Phase III studies recruiting patients and two others which will start recruiting patients over the next few months. Our first marketed product, Arzerra (ofatumumab) is now approved in Europe in combination with chlorambucil or bendamustine to treat first line CLL patients who are not eligible for fludarabine-based therapy. Ofatumumab is still in clinical development for other indications and we were very pleased to have met the primary endpoint in the interim analysis of the Phase III maintenance study in relapsed CLL in July. We remain focused on developing our future pipeline and to that end announced a collaboration to use Seattle Genetics’ clinically validated ADC technology with our newly named pre-clinical antibody, HuMax-AXL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months
- Genmab’s revenue increased DKK 187 million or 42% to DKK 635 million in the first nine months of 2014. The increase was mainly driven by higher revenue related to our daratumumab collaboration with Janssen Biotech, Inc. (Janssen); partly offset by lower milestones and royalties related to our collaboration with GlaxoSmithKline (GSK).
- Operating expenses were held flat year over year and were DKK 431 million in the first nine months of 2014 compared to DKK 432 million in the first nine months of 2013.
- Operating income was DKK 204 million in the first nine months of 2014 compared to DKK 16 million in the corresponding period for 2013, an improvement of DKK 188 million which was driven by increased revenue.
· On September 30, 2014, Genmab had a cash position of DKK 2,639 million. This represented a net increase of DKK 1,082 million from the beginning of 2014. The increase was driven by net proceeds of DKK 972 million received from the private placement in January 2014.
Business Progress Third Quarter to Present
Ofatumumab
- November: Entered into an agreement with GSK and Novartis to transfer the ofatumumab collaboration with GSK to Novartis. The parties have also agreed that Genmab would not be required to pay existing funding liabilities (approximately GBP 19 million) or to fund research and development costs for ofatumumab beyond December 31, 2014. In aggregate, this could reduce Genmab’s funding commitment by up to GBP 60 million. The transfer of the collaboration will only become effective upon closing of the GSK/Novartis Transaction, which is currently expected in the first half of 2015.
- October: GSK reported net sales for Arzerra for the third quarter of 2014 of GBP 13.8 million, resulting in royalty income of approximately DKK 27 million to Genmab.
- July: An Independent Data Monitoring Committee (IDMC) interim analysis of a Phase III study, PROLONG, evaluating ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed CLL who responded to treatment at relapse met the primary endpoint of improving progression free survival (PFS), reaching the predefined significance level for efficacy (p<0.001). The study is no longer recruiting patients.
- July: Marketing authorization was granted in the EU for the use of Arzerra in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Daratumumab
- October: Reached the fourth milestone in the daratumumab collaboration with Janssen, triggering a USD 10 million payment to Genmab for progress in the ongoing Phase III study (“Castor” MMY3004) of daratumumab in combination with bortezomib and dexamethasone compared to bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.
- August: Announced a Phase III study (“Maia” MMY3008) of daratumumab in combination with lenalidomide and dexamethasone compared to lenalidomide and dexamethasone alone as front line treatment for multiple myeloma patients who are not considered candidates for stem cell transplantation (SCT). The study is planned to start in the first half of 2015.
- July: Announced a Phase III study (“Alcyone” MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone compared to bortezomib, melphalan and prednisone alone as front line treatment for multiple myeloma patients who are not considered candidates for SCT. The study is expected to start in the fourth quarter of 2014.
- July: Reached the third milestone in the daratumumab collaboration with Janssen triggering a USD 25 million payment to Genmab for progress in the ongoing Phase III study (“Pollux” MMY3003) of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.
Other
- September: Entered a collaboration to utilize Seattle Genetics’ ADC technology with our HuMax-AXL antibody, currently in pre-clinical development.
- July: Reached a milestone in the DuoBody® technology platform collaboration with Janssen, triggering a USD 3 million milestone payment for pre-clinical progress with a DuoBody product candidate in autoimmune disease.
Outlook
Genmab is maintaining the 2014 financial guidance published on August 13, 2014.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2014 today, Wednesday, November 5, 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
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.
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
Download the full Interim Report for the First Nine Months of 2014 on attachment or at www.genmab.com.
