Genmab Announces Financial Results for the First Nine Months of 2019
November 06 2019 - 11:01AM
November 6, 2019; Copenhagen,
Denmark; Interim Report for the First Nine Months
Ended September 30, 2019
Highlights
- Completion of public offering
and listing of American Depository Shares (ADSs) on Nasdaq Global
Select Market under the symbol “GMAB.” Total gross proceeds from
the issuance of new shares amounted to USD 582 million (DKK 3,873
million) with a corresponding increase in share capital of
3,277,500 ordinary shares or 32,775,000 ADSs
- Positive data reported by
Novartis for the Phase III ASCLEPIOS I & II studies of
subcutaneous ofatumumab in relapsing multiple sclerosis
(RMS)
- DARZALEX® (daratumumab) approved in the U.S. in
combination with bortezomib, thalidomide and dexamethasone (VTd)
and in Japan in combination with bortezomib, melphalan and
prednisone (VMP) in various multiple myeloma frontline
settings
- Positive topline results for
daratumumab in both the Phase III CANDOR and Phase II GRIFFIN
studies in various multiple myeloma settings
- Biologics License Application
(BLA) submitted to U.S. Food and Drug Administration (U.S. FDA) for
the subcutaneous formulation of daratumumab; standard review
received. An extension of marketing authorization for this
formulation was also submitted to the European Medicines Agency
(EMA)
- DARZALEX net sales increased
50% compared to the first nine months of 2018 to USD 2,168 million,
resulting in royalty income of DKK 2,033 million
- Genmab is improving its 2019 financial guidance mainly
due to positive foreign exchange movements between the USD and DKK
resulting in increased milestone income and royalties on sales of
DARZALEX
“Genmab made excellent progress across many areas
of the business during the third quarter of 2019. Of key
significance was the completion of our public offering of American
Depositary Shares and listing on the Nasdaq Global Select Market in
the U.S. Genmab’s status as a dual listed company both increases
our visibility as an innovation powerhouse and provides additional
support for the development of our exciting pipeline of antibody
product candidates,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “Over the past three months advances to this
pipeline included positive data readouts for ofatumumab in
relapsing multiple sclerosis and daratumumab in multiple myeloma,
regulatory submissions for daratumumab and teprotumumab and
additional approvals for daratumumab in the U.S. and Asia. In
addition, we entered into new strategic collaborations with
companies such as Tempus and BliNK Biomedical, which will allow us
to expand our pipeline in new directions as Genmab continues to
move towards our goal of transforming cancer treatment.”
Financial Performance First Nine Months of
2019
- Revenue was DKK 2,405 million in the
first nine months of 2019 compared to DKK 1,789 million in the
first nine months of 2018. The increase of DKK 616 million, or 34%,
was mainly driven by higher DARZALEX royalties and reimbursement
income from our collaborations with Seattle Genetics and BioNTech,
partly offset by the one-time payment from Novartis of USD 50
million (DKK 304 million) during the first nine months 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-U.S. markets.
- Net sales of DARZALEX by Janssen were
USD 2,168 million in the first nine months of 2019 compared to USD
1,441 million in the first nine months of 2018, an increase of USD
727 million, or 50%.
- Operating expenses were DKK 1,943
million in the first nine months of 2019 compared to DKK 1,130
million in the first nine months of 2018. The increase of DKK 813
million, or 72%, was driven by the advancement of tisotumab vedotin
and enapotamab vedotin, additional investments in our product
pipeline, and the increase in new employees to support the
expansion of our product pipeline.
- Operating income was DKK 462 million
in the first nine months of 2019 compared to DKK 659 million in the
first nine months of 2018. As anticipated, the decrease of DKK 197
million, or 30%, was driven primarily by increased operating
expenses and the one-time payment from Novartis in 2018.
Outlook
Genmab is improving its 2019 financial guidance published on August
14, 2019 mainly due to positive foreign exchange movements between
the USD and DKK resulting in increased milestone income and
royalties on sales of DARZALEX.
MDKK |
Revised Guidance |
Previous Guidance |
Revenue |
5,100 |
4,800 |
Operating expenses |
(2,750) |
(2,750) |
Operating income |
2,350 |
2,050 |
Conference CallGenmab will hold a
conference call in English to discuss the results for the first
nine months of 2019 today, Wednesday, November 6, at 6:00 pm CET,
5:00 pm GMT or 12:00 pm EST. To join the call dial +1 631 510 7495
(U.S. participants) or +44 2071 928000 (international participants)
and provide conference code 7996106. 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: mmp@genmab.com
For Investor Relations: Andrew
Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E:
acn@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 pre-clinical and clinical development of
products, 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 that may render our products
or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s final prospectus for our U.S. public offering and listing
and other filings with the U.S. Securities and Exchange Commission
(SEC), available at www.sec.gov.Genmab does not undertake any
obligation to update or revise forward looking statements in the
interim report nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law. Genmab A/S and/or its
subsidiaries own the following trademarks: Genmab®; the Y-shaped
Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®;
HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®;
HexaBody®; HexaBody in combination with the HexaBody logo®;
DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of
Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen
Pharmaceutica NV.
Download the full Interim Report for the First Nine
Months of 2019 on attachment or at www.genmab.com.
CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122
Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark
- 191106_Q3 2019 Interim Report
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