Genmab Announces Financial Results for the First Quarter of 2013
07 Mai 2013 - 5:08PM
Interim Report First Quarter 2013
- Arzerra(r) received approval in Japan
- Arzerra net sales increased 65% over Q1
2012
- Manufacturing facility sold to Baxter
- Improved operating result by DKK 73 million over Q1
2012
"We expect 2013 to be another exciting and productive year at
Genmab and are working hard to fulfill the objectives we set for
this year. We were pleased to gain approval for Arzerra in Japan,
the first Asian territory to give marketing authorization to the
product, as well as to see growing sales during Q1. We recently
reported impressive top line results from a Phase II study using
ofatumumab together with bendamustine to treat CLL patients and
look forward to reporting important Phase III data from our
frontline CLL study with ofatumumab in the coming time," said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
- Genmab's revenue was DKK 160 million for the first quarter of
2013 compared to DKK 94 million for the corresponding period in
2012. The increase of DKK 66 million or 70% was mainly driven by
higher Arzerra royalties, revenue related to our daratumumab
collaboration with Janssen Biotech (Janssen) and the achievement of
a milestone under our collaboration with GlaxoSmithKline
(GSK).
- Operating expenses decreased 5% from DKK 138 million in the
first quarter of 2012 to DKK 131 million in the first quarter of
2013.
- Operating income was DKK 29 million in the first quarter of
2013 compared to an operating loss of DKK 44 million in the
corresponding period for 2012, an improvement of DKK 73 million.
The improved operating result was driven by increased revenue and
continued strong focus on cost control.
- The net result for discontinued operation amounted to a net
income of DKK 42 million in the first quarter of 2013. The net
income in 2013 related to the final few months of running costs of
the Minnesota manufacturing facility of DKK 10 million prior to its
divestiture and a gain on the sale of DKK 52 million. The facility
maintenance cost amounted to DKK 10 million in the first quarter of
2012.
- On March 31, 2013, Genmab had a cash position of DKK 1,554
million. This represented a net increase of DKK 38 million from the
beginning of 2013, which was primarily related to proceeds received
from the sale of the manufacturing facility. The cash burn for the
first quarter of 2012 was DKK 74 million.
Business Progress First Quarter to Present
- February: The Minnesota manufacturing facility was sold to
Baxter Healthcare (Baxter) Corporation for USD 10 million.
- March: Arzerra received approval in Japan for use in patients
with relapsed/refractory CD20-positive chronic lymphocytic leukemia
(CLL). The approval triggered a milestone payment of DKK 20 million
from GSK to Genmab.
- April: The US Food and Drug Administration (FDA) granted Fast
Track designation for daratumumab. This designation covers patients
with multiple myeloma who have received at least three prior lines
of therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent (IMiD) or are double refractory to a PI and
an IMiD.
- April: GSK reported net sales for Arzerra for the first quarter
of 2013 of GBP 20.5 million, an increase of 65% over Q1 2012,
resulting in royalty income of DKK 36 million to Genmab. A large
portion of the rest of the world sales in the first quarter of 2013
were related to the supply of ofatumumab for clinical trials run by
other companies, and as such does not reflect ongoing commercial
demand.
- April: The U.S. Court of Appeals for the Federal Circuit upheld
the U.S. District Court's judgment in favor of GSK in a patent
infringement case involving Arzerra brought against GSK by
Genentech and Biogen Idec.
- May: Reported impressive top line data from a Phase II study of
ofatumumab in combination with bendamustine in patients with
untreated or relapsed CLL. The overall response rate (ORR) in the
study was 95% in previously untreated patients and 74% in patients
with relapsed CLL.
- May: The US FDA granted Breakthrough Therapy Designation for
daratumumab for the treatment of patients with multiple myeloma who
have received at least three prior lines of therapy including a PI
and an IMiD or who are refractory to a PI and an IMiD.
Outlook
Genmab is maintaining its 2013 financial guidance as announced
on March 7, 2013.
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first quarter of 2013 today, Tuesday, May 7, at
6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:
+1 866 682 8490 (US participants) and ask for the Genmab
conference call +44 1452 555 131 (international participants) and
ask for the Genmab conference call A live and archived webcast of
the call and relevant slides will be available at
www.genmab.com.
ABOUT GENMAB A/S Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated human antibody therapeutics for
the treatment of cancer. Founded in 1999, the company's first
marketed antibody, ofatumumab (Arzerra(r)), was approved to treat
chronic lymphocytic leukemia in patients who are refractory to
fludarabine and alemtuzumab after less than eight years in
development. Genmab's validated and next generation antibody
technologies are expected to provide a steady stream of future
product candidates. Partnering of innovative product candidates and
technologies is a key focus of Genmab's strategy and the company
has alliances with top tier pharmaceutical and biotechnology
companies. For more information visit www.genmab.com.
This 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 product discovery and development, 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 obsolete, and other
factors. For a further discussion of these risks, please refer to
the section "Risk Management" in Genmab's annual report, which is
available on www.genmab.com and the "Significant Risks and
Uncertainties" section in this interim report. Genmab does not
undertake any obligation to update or revise forward looking
statements in this interim report nor to confirm such statements in
relation to actual results, unless required by law.
Genmab(r); the Y-shaped Genmab logo(r); the DuoBody logo(r);
HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(tm) and UniBody(r)are
all trademarks of Genmab A/S. Arzerra(r) is a trademark of
GlaxoSmithKline.
Company Announcement no. 20 CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark
CONTACT: Rachel Curtis Gravesen, Senior Vice President,
Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60
E: r.gravesen@genmab.com