Genmab Announces Financial Results for the First Half of 2016 and Improves 2016 Financial Guidance

COPENHAGEN, Denmark, Aug. 9, 2016 (GLOBE NEWSWIRE) -- Interim Report for First Half 2016

Highlights

  • Net Sales of DARZALEX(r) (daratumumab) by Janssen for the first half of 2016 were USD 209 million, resulting in royalty income of USD 25 million (DKK 168 million)
  • 2016 financial guidance improved
  • Announced European conditional marketing authorization of DARZALEX for heavily pre-treated or double-refractory multiple myeloma
  • Achieved USD 30 million milestone for first commercial sale of DARZALEX in Europe
  • Announced positive topline result in Phase III POLLUX study of daratumumab in relapsed or refractory multiple myeloma
  • Announced that U.S. Food and Drug Administration (FDA) granted priority review to sBLA for ofatumumab (Arzerra(r)) in combination with fludarabine and cyclophosphamide (FC) in relapsed chronic lymphocytic leukemia (CLL)
  • Announced that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Arzerra as maintenance therapy in relapsed CLL
  • Announced Phase III studies of ofatumumab in relapsing multiple sclerosis

"The two major highlights during the second quarter were the rapid European approval of DARZALEX and positive Phase III data from the POLLUX study. DARZALEX was successfully launched by our collaboration partner Janssen shortly after the approval, triggering a milestone payment of USD 30 million to Genmab. We were also very excited about the Phase III POLLUX study data which showed that daratumumab in combination with lenalidomide and dexamethasone led to a significant improvement in progression free survival in treatment of relapsed or refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half

  • Revenue was DKK 524 million in the first half of 2016 compared to DKK 281 million in the first half of 2015. The increase of DKK 243 million, or 86%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
  • Operating expenses were DKK 366 million in the first half of 2016 compared to DKK 244 million in the first half of 2015. The increase of DKK 122 million, or 50%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax(r)-AXL-ADC, HexaBody(r)-DR5/DR5, DuoBody(r)-CD3xCD20, and our other pre-clinical programs.
  • Operating income was DKK 158 million in the first half of 2016 compared to DKK 212 million in the first half of 2015. The decrease of DKK 54 million, or 25%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015 combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
  • On June 30, 2016, Genmab had a cash position of DKK 3,762 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 269 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants for DKK 82 million.

Business Progress Second Quarter

Daratumumab

  • May: Achieved a USD 30 million milestone triggered by the first commercial sale of DARZALEX in Europe.
  • May: Announced that the European Commission (EC) granted a conditional marketing authorization for DARZALEX for heavily pre-treated or double-refractory multiple myeloma. The approval followed a positive recommendation for DARZALEX from the CHMP of the European Medicines Agency (EMA) in April.
  • May: Announced that the Phase III POLLUX study (MMY3003) of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p<0.0001). Patients who received treatment with daratumumab in combination with lenalidomide and dexamethasone had a 63% reduction in risk of their disease progressing, compared to those who did not receive daratumumab. The median progression free survival (PFS) for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 18.4 months for patients who received lenalidomide and dexamethasone alone. Janssen will engage in a dialogue with health authorities about the potential for a regulatory submission for this indication.
  • April: Reported more detailed data from the Phase III CASTOR (MMY3004) study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met the primary endpoint of improving PFS; HR = 0.39, p<0.0001. The median PFS for patients treated with daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab.
  • April: Announced that MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Janssen Biotech, Inc. (Janssen), for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the manufacture, use and sale of DARZALEX in the United States. Genmab and Janssen disagree with the allegations made by MorphoSys in its complaint for patent infringement and intend to vigorously contest those allegations.

Ofatumumab

  • June: Announced that the CHMP of the EMA issued a negative opinion on the use of Arzerra as maintenance therapy for patients with relapsed CLL.
  • June: Announced that Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrollment of patients to start in September 2016.
  • May: Announced that the U.S. FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab in combination with FC for the treatment of patients with relapsed CLL.

Subsequent Event

  • July: The U.S. FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy.

Outlook
Genmab is improving its 2016 financial guidance published on April 20, 2016 and reiterated on May 10, 2016, due to increased revenue and operating expenses resulting in increased operating income and cash position.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2016 today, Tuesday, August 9, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:

+1 212 444 0481 (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.

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.

Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); the Y-shaped Genmab logo(r); Genmab in combination with the Y-shaped Genmab logo(tm); the DuoBody logo(r); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(r) and UniBody(r). Arzerra(r) is a trademark of Novartis AG or its affiliates. DARZALEX(r) is a trademark of Janssen Biotech, Inc.

CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

Download the full Interim Report for the first half of 2016 on attachment or at www.genmab.com.

Source:Genmab A/S