Company Announcement
Copenhagen, Denmark; February 19, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today the publication
of its Annual Report for 2019. Below is a summary of
business progress in 2019, financial performance for the year and
the financial outlook for 2020. The full report is attached as a
PDF file and can be found on the investor section of the company’s
website, www.genmab.com. An online summary of the report is
available at https://2019overview.genmab.com.
Conference CallGenmab will hold a conference
call in English to discuss the full year results for 2019 today,
February 19, 2020 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join
the call dial +1 631 510 7495 (US participants) or +44 2071 928000
(international participants) and provide conference code
4887886.
A live and archived webcast of the call and relevant slides will
be available at www.genmab.com.
2019 ACHIEVEMENTSBusiness
ProgressDaratumumab
- U.S. FDA decision on Phase III MAIA multiple myeloma (MM)
submission - achieved
- U.S. FDA decision on Phase III CASSIOPEIA MM submission -
achieved
- Phase III COLUMBA MM subcutaneous daratumumab safety and
efficacy analysis - achieved
Ofatumumab ·Phase III
ASCLEPIOS I & II relapsing multiple sclerosis SubQ ofatumumab
study completion and reporting – achieved
Tisotumab vedotin ·Phase II
innovaTV 204 tisotumab vedotin recurrent / metastatic cervical
cancer study enrollment complete by mid-year - achieved
Innovative Pipeline
- Phase II enapotamab vedotin expansion cohort efficacy analysis
- achieved
- Phase I/II HexaBody®-DR5/DR5 initial clinical data – initial
data now anticipated in 2020
- Phase I/II epcoritamab (DuoBody®-CD3xCD20) clinical data dose
escalation cohorts - achieved
- File INDs and/or CTAs for 3 new product candidates -
achieved
U.S. IPO
- Genmab successfully completed an initial public offering (IPO)
of American Depositary Shares (ADSs) on the Nasdaq Global Select
Market
- Achievement made Genmab a dual-listed company listed on both
the Nasdaq Copenhagen in Denmark and the Nasdaq Global Select
Market in the U.S.
Financial Performance
- Revenue was DKK 5,366 million in 2019 compared to DKK 3,025
million in 2018. The increase of DKK 2,341 million, or 77%, was
mainly driven by higher DARZALEX royalties and milestones achieved
under our daratumumab collaboration with Janssen.
- Operating expenses increased by DKK 1,083 million, or 66%, from
DKK 1,645 million in 2018 to DKK 2,728 million in 2019 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 2,638 million in 2019 compared to DKK
1,380 million in 2018. The improvement of DKK 1,258 million, or
91%, was driven by higher revenue, which was partly offset by
increased operating expenses.
- 2019 year-end cash position of DKK 10,971 million, an increase
of DKK 4,865 million, or 80%, from DKK 6,106 million as of December
31, 2018.
2020 OUTLOOK
DKK million |
2020 Guidance |
2019 Actual Result |
Revenue |
4,750 – 5,150 |
5,366 |
Operating expenses |
(3,850) – (3,950) |
(2,728) |
Operating income |
850 – 1,250 |
2,638 |
Revenue We expect our 2020 revenue to be in the
range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million
in 2019. Our revenue in 2019 included DKK 1,684 million related to
one-time sales milestones for DARZALEX net sales exceeding USD 2.5
billion and 3.0 billion in a calendar year.
Our projected revenue for 2020 primarily consists of DARZALEX
royalties of DKK 4,075 – 4,475 million. Our 2020 guidance for
DARZALEX royalties represents a 30% to 43% increase compared to
2019. Such royalties are based on estimated DARZALEX net sales of
USD 3.9 – 4.2 billion. We project cost reimbursement income of
approximately DKK 475 million which is related to our
collaborations with Seattle Genetics and BioNTech. The remainder of
our revenue is approximately DKK 200 million and consists of
milestones and other royalties.
Operating Expenses We anticipate our 2020
operating expenses to be in the range of DKK 3,850 – 3,950 million,
compared to DKK 2,728 million in 2019. The increase is driven by
the advancement of our clinical programs, particularly epcoritamab
(DuoBody-CD3x-CD20) and DuoBody-PD-L1x4-1BB.
Operating Result We expect our operating income
to be in the range of DKK 850 – 1,250 million in 2020 compared to
DKK 2,638 million in 2019.
More information on the Risks and Assumptions for the 2020
Financial Guidance can be found in the 2019 Annual Report available
on our website www.genmab.com.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
three approved antibodies: DARZALEX® (daratumumab, under agreement
with Janssen Biotech, Inc.) for the treatment of certain multiple
myeloma indications in territories including the U.S., Europe and
Japan, Arzerra® (ofatumumab, under agreement with Novartis AG), for
the treatment of certain chronic lymphocytic leukemia indications
in the U.S., Japan and certain other territories and TEPEZZA™
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. Daratumumab is in clinical development by Janssen for
the treatment of additional multiple myeloma indications, other
blood cancers and amyloidosis. A subcutaneous formulation of
ofatumumab is in development by Novartis for the treatment of
relapsing multiple sclerosis. Genmab also has a broad clinical and
pre-clinical product pipeline. Genmab's technology base consists of
validated and proprietary next generation antibody technologies -
the DuoBody® platform for generation of bispecific antibodies, the
HexaBody® platform, which creates effector function enhanced
antibodies, the HexElect® platform, which combines two
co-dependently acting HexaBody molecules to introduce selectivity
while maximizing therapeutic potency and the DuoHexaBody® platform,
which enhances the potential potency of bispecific antibodies
through hexamerization. The company intends to leverage these
technologies to create opportunities for full or co-ownership of
future products. Genmab has alliances with top tier pharmaceutical
and biotechnology companies. Genmab is headquartered in Copenhagen,
Denmark with sites in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan.
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
This Company Announcement 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 which 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), which are available at www.sec.gov. Genmab does not
undertake any obligation to update or revise forward looking
statements in this Company Announcement 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. TEPEZZA™ is a trademark of
Horizon Therapeutics plc.
CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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