August 13, 2014; Copenhagen, Denmark;
Interim Report First Half 2014
- Announced three new Phase III studies of daratumumab in multiple myeloma and improved guidance twice
- Achieved USD 25 million milestone payment under Janssen Biotech, Inc. collaboration for daratumumab
- Arzerra® (ofatumumab) label expansion in US and 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 GSK plans to start pivotal studies of subcutaneous ofatumumab in relapsing-remitting multiple sclerosis (RRMS) and neuromyelitis optica (NMO)
- Signed first HexaBody™ technology platform research collaboration agreement
- Reported topline data from two Phase III studies of ofatumumab – primary endpoints not met
- Improved operating result by DKK 54 million over H1 2013
“We continue to make solid progress across our business as the year progresses. The label expansion for Arzerra to include treatment of first-line patients with CLL in the US in combination with chlorambucil in April was followed closely by approval in Europe for Arzerra in combination with chlorambucil or bendamustine. We were pleased to announce that the Phase III study of ofatumumab as maintenance therapy in relapsed CLL met its primary endpoint at an interim analysis. Furthermore, we announced three new Phase III studies of daratumumab in combination with backbone therapies, one in relapsed or refractory multiple myeloma and two in first line multiple myeloma. In July we reached a USD 25 million milestone based on progress in the first Phase III study under our collaboration with Janssen and have again been able to improve our financial guidance,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
- Genmab’s revenue increased DKK 65 million or 22% to DKK 363 million in the first half 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 GSK.
- Operating expenses were DKK 298 million in the first half of 2014, compared to DKK 287 million in the first half of 2013, an increase of DKK 11 million or 4%.
- Operating income was DKK 65 million in the first half of 2014 compared to an operating income of DKK 11 million in the corresponding period for 2013, an improvement of DKK 54 million, which was driven by increased revenue, partly offset by the increase in operating expenses.
- On June 30, 2014, Genmab had a cash position of DKK 2,584 million. This represented a net increase of DKK 1,027 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 Second Quarter to Present
Ofatumumab
- 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, reached the predefined significance level for efficacy (p<0.001). The interim analysis demonstrated that treatment with ofatumumab met the primary endpoint of improving progression free survival (PFS).
- July: GlaxoSmithKline (GSK) reported net sales for Arzerra for the second quarter of 2014 of GBP 12.8 million, resulting in royalty income of approximately DKK 23 million to Genmab.
- 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.
- June: Topline data from the Phase III study of ofatumumab versus physician’s choice in patients with bulky fludarabine-refractory CLL showed that the study did not meet its primary endpoint.
- May: Announced that GSK has taken the decision to start Phase III studies of subcutaneous ofatumumab in RRMS in 2015, and plans to file an Investigational New Drug application (IND) for a potential pivotal study of subcutaneous ofatumumab in NMO in 2014.
- May: Topline results from the Phase III study (ORCHARRD) of ofatumumab in combination with chemotherapy versus rituximab in combination with chemotherapy for relapsed or refractory DLBCL showed that the study did not meet its primary endpoint.
- April: The US FDA approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
Daratumumab
- August: Announced a Phase III study 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 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 of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.
- May: A Phase III study investigating daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma was announced. 2014 guidance was improved on May 1 due to the inclusion of an anticipated milestone related to this Phase III study.
Technology
- 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.
- June: Entered a research collaboration with an undisclosed major biotechnology company which will use and evaluate the DuoBody and HexaBody platforms. This is the first collaboration for the HexaBody platform.
Outlook
Genmab is improving its 2014 financial guidance published on May 1, 2014, due to increased revenue.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2014 today, Wednesday, August 13, 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.
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 Half 2014 on attachment or at www.genmab.com.
