On November 14, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the first commercial sale of DARZALEX (daratumumab) in Japan has taken place, triggering USD 25 million in milestone payments from Janssen Biotech, Inc. (Janssen). The milestone was mentioned at the time of the September 2017 announcement of the approval of DARZALEX for the treatment of adults with relapsed or refractory multiple myeloma in Japan (Press release, Genmab, NOV 14, 2017, View Source [SID1234522064]). As a result of this milestone, Genmab is updating its 2017 financial guidance.
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"We’re pleased that DARZALEX is now commercially available for patients with relapsed or refractory multiple myeloma who are living in Japan," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
OUTLOOK
MDKK Revised Guidance Previous Guidance
Revenue 2,110 — 2,310 1,950 — 2,150
Operating expenses (1,000) — 1,100) (1,000) — (1,100)
Operating income 1,060 — 1,260 900 — 1,100
Cash position at end of year* >4,900 >4,500
*Cash, cash equivalents, and marketable securities
Genmab is improving its 2017 financial guidance last published on November 8, 2017 due to the inclusion of the DARZALEX milestones totaling USD 25 million associated with first commercial sale of DARZALEX in Japan.
Operating Result
We expect our 2017 revenue to be in the range of DKK 2,110 — 2,310 million, an increase of DKK 160 million compared to the previous guidance. We have increased our projected daratumumab milestones to DKK 960 million (previously DKK 800 million) due to inclusion of USD 25 million in milestone payments triggered by the first commercial sale of DARZALEX in Japan. We expect DARZALEX royalties to remain in the range of DKK 930 — 1,100 million, which are based on an estimated USD 1,100 — 1,300 million of DARZALEX sales in 2017. The remainder of the revenue mainly consists of Arzerra royalties, DuoBody milestones, and non-cash amortization of deferred revenue.
We anticipate that our 2017 operating expenses will remain in the range of DKK 1,000 —1,100 million.
As a result of the increased revenue, we now expect the operating income for 2017 to be approximately DKK 1,060 — 1,260 million, compared to DKK 900 — 1,100 million in the previous guidance.
Cash Position
As a result of the above and proceeds from the exercise of warrants during the year, we are now projecting a cash position at the end of 2017 of greater than DKK 4,900 million.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX and Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2017 that could materially affect the results.