On May 8, 2019 Genmab reported that Interim Report for the First Quarter Ended March 31, 2019 (Press release, Genmab, MAY 8, 2019, View Source [SID1234535921])
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Highlights
Regulatory applications for daratumumab in combination with lenalidomide and dexamethasone based on the MAIA study in frontline multiple myeloma submitted in U.S. and Europe
Regulatory applications for daratumumab in combination with bortezomib, thalidomide and dexamethasone based on the CASSIOPEIA study in frontline multiple myeloma submitted in U.S. and Europe
Positive topline results from Phase III COLUMBA study of subcutaneous daratumumab for relapsed or refractory multiple myeloma
MorphoSys patent infringement complaint against Genmab and Janssen Biotech, Inc. dismissed, MorphoSys patents ruled invalid for lack of enablement, case ended
DARZALEX net sales increased 46% over Q1 2018 to USD 629 million, resulting in royalty income of DKK 502 million
"The first quarter was filled with regulatory news for DARZALEX, with our collaboration partner Janssen filing multiple new regulatory applications and achieving one new approval. In addition, we reported positive topline data for subcutaneous daratumumab in relapsed or refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "During the first quarter we also continued to invest in and advance our innovative proprietary products under development using Genmab’s expertise in antibody drug development to create truly differentiated products to help cancer patients."
Financial Performance First Quarter of 2019
Revenue was DKK 591 million in the first quarter of 2019 compared to DKK 681 million in the first quarter of 2018. The decrease of DKK 90 million, or 13%, was mainly driven by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first quarter of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets, partly offset by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech.
Operating expenses were DKK 617 million in the first quarter of 2019 compared to DKK 357 million in the first quarter of 2018. The increase of DKK 260 million, or 73%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating loss was DKK 26 million in the first quarter of 2019 compared to operating income of DKK 324 million in the first quarter of 2018. As anticipated, the decrease of DKK 350 million, or 108%, was driven primarily by the one-time payment from Novartis in 2018 and increased operating expenses.
Outlook
Genmab is maintaining its 2019 financial guidance published on February 20, 2019.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2019 today, Wednesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. To join the call dial
+1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 8692103.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
Contact:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: [email protected]
For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: [email protected]