May 10, 2017; Copenhagen, Denmark;
Interim Report for the First Quarter of 2017
Highlights
USD 255 million in net sales of DARZALEX® (daratumumab); resulting in royalty income of DKK 211 million
DARZALEX received positive opinion from European regulatory authorities for relapsed or refractory multiple myeloma
Judith Klimovsky, MD appointed Chief Development Officer
Phase II study of daratumumab in non-Hodgkin's lymphoma (CARINA) did not proceed to stage 2 of trial
"In the first quarter of 2017 we received a positive regulatory opinion for DARZALEX in combination with standard therapies for relapsed or refractory multiple myeloma in the EU, and continued to progress our other pipeline projects. As part of our aim to grow into a sustainably profitable company, we also strengthened our executive management team with the appointment of Judith Klimovsky, MD, as Executive Vice President and Chief Development Officer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2017
Revenue was DKK 251 million in the first quarter of 2017 compared to DKK 170 million in the first quarter of 2016. The increase of DKK 81 million, or 48%, was mainly driven by increased DARZALEX royalties, partly offset by a decrease in milestone income.
Operating expenses were DKK 205 million in the first quarter of 2017 compared to DKK 154 million in the first quarter of 2016. The increase of DKK 51 million, or 33%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax®-AXL-ADC, HexaBody®-DR5/DR5, DuoBody®-CD3xCD20, and the various products in our pre-clinical pipeline.
Operating income was DKK 46 million in the first quarter of 2017 compared to DKK 16 million in the first quarter of 2016. The increase of DKK 30 million, or 188%, was driven by higher revenue which was partly offset by the increased operating expenses in 2017.
On March 31, 2017, Genmab had a cash position of DKK 4,751 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 829 million, which was mainly driven by positive working capital adjustments of DKK 665 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, proceeds from the exercise of warrants of DKK 103 million, and operating income.
Subsequent Event
April: The European Commission granted a marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The approval converts the previous conditional marketing authorization for DARZALEX to a full approval. Genmab will receive milestone payments totaling USD 48 million from Janssen in connection with the first commercial sales of DARZALEX under the expanded label. The sales are expected to occur quickly after the approval.
Outlook
Genmab is maintaining its 2017 financial guidance published on February 22, 2017.