On November 3, 2015 Genmab reported Interim Report for the Nine Months Ended September 30, 2015 (Press release, Genmab, NOV 3, 2015, View Source [SID:1234507921]).

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Daratumumab granted Priority Review by U.S. Food and Drug Administration (FDA) and accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)

Achieved USD 25 million in milestone payments from Janssen related to the regulatory applications submitted to the FDA and EMA for daratumumab

Regulatory submissions for ofatumumab (Arzerra) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA — Priority Review granted by FDA

Entered commercial license agreement with Novo Nordisk for DuoBody technology

Improved operating result by DKK 151 million over the first nine months of 2014

2015 financial guidance improved

"The third quarter was certainly a busy one in terms of regulatory filings for our antibody programs. We were very pleased that the FDA granted Priority Review and the EMA granted accelerated assessment to the regulatory applications for daratumumab in heavily pretreated or double refractory multiple myeloma patients. Regulatory submissions for ofatumumab as maintenance treatment for relapsed CLL were also submitted in the US and Europe and the US application received Priority Review. We also announced a new commercial agreement for the DuoBody technology with Novo Nordisk this quarter. With the end of the year coming up fast, we will continue to work towards our annual goals, while maintaining our focus on our vision of transforming cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months
Revenue was DKK 558 million in the first nine months of 2015 compared to DKK 635 million in the first nine months of 2014. The decrease of DKK 77 million or 12% was mainly driven by lower milestone and cost reimbursement revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 380 million in the first nine months of 2015 compared to DKK 431 million in the first nine months of 2014. The decrease of DKK 51 million or 12% 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 development pipeline.
Operating income was DKK 355 million in the first nine months of 2015 compared to DKK 204 million in the first nine months of 2014. The improvement of DKK 151 million was driven by the positive effect from the reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.

On September 30, 2015, Genmab had a cash position of DKK 3,206 million. This represented a net increase of DKK 545 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 598 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.

Business Progress Third Quarter to Present

Daratumumab
September: The CHMP of the EMA granted accelerated assessment to the Marketing Authorization Application (MAA) for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma.

September: The MAA for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma was submitted to the EMA by Janssen-Cilag International NV. The submission triggered a USD 10 million milestone payment to Genmab from Janssen.

September: The U.S. FDA granted Priority Review to the Biologics License Application (BLA) for daratumumab as a treatment for patients with double refractory multiple myeloma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

July: The rolling submission of a BLA to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab.

Other
September: The U.S. FDA granted Priority Review to the sBLA for ofatumumab as maintenance therapy for patients with relapsed CLL. The FDA assigned a PDUFA target date of January 21, 2016.

August: Entered an agreement granting Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs.

July: Announced that Novartis submitted regulatory applications to the EMA and FDA for the use of ofatumumab as maintenance therapy for patients with relapsed CLL.

Q4 Events
October: Achieved five pre-clinical milestones under our DuoBody technology collaboration with Janssen, triggering total payments of USD 8.5 million to Genmab.

Outlook
Genmab is improving its 2015 financial guidance published on August 19, 2015, due to increased revenue and lower operating expenses resulting in increased operating income and cash position.