Genmab A/S (Copenhagen:GEN)
today
published its Annual Report for 2012. Below is a
summary from the report of business progress and financial
performance for the year and financial outlook for 2013. The full
report is attached in PDF form or can be found on the investor
section of the company's website, www.genmab.com.
IMPRESSIVE 2012 ACHIEVEMENTS
Business Progress
Maximizing the Value of Ofatumumab
> Reported
Phase II data in fludarabine and alemtuzumab refractory chronic
lymphocytic leukemia (CLL) at American Society of Clinical Oncology
(ASCO) meeting
> Independent
Data Monitoring Committee (IDMC) recommended continuing Phase III
study of ofatumumab plus chemotherapy versus rituximab plus
chemotherapy in diffuse large B-cell lymphoma (DLBCL) following
interim analysis
> Data from
11 Investigator Sponsored Studies (ISS) presented at three major
medical conferences o Amended protocol for Phase
III head-to-head DLBCL study, bringing timeline forward by one year
o Completed patient enrollment in Phase III study
of ofatumumab in combination with fludarabine and cyclophosphamide
(FC) vs FC in patients with relapsed CLL
o Initiated new Phase I/II study of ofatumumab
plus chlorambucil in previously untreated Japanese patients with
CLL o Completed patient enrollment in Phase II
study of ofatumumab in combination with bendamustine for treatment
of front line and relapsed CLL o Completed patient
enrollment in Phase IV observational study in CLL
o Presented Phase II follicular lymphoma (FL) data
at American Society of Hematology (ASH) meeting
x Phase III CLL
maintenance safety interim data analysis expected H1 2013, no
impact on trial timeline
Expansion of Arzerra(r)
> First
launch in South America; launched in 26 countries by end of 2012
> GlaxoSmithKline
(GSK) submitted New Drug Application (NDA) in Japan
o GSK sales increased in British pounds by 38%,
resulting in DKK 111 million in royalty income to Genmab
Advancing Daratumumab
> Reported
efficacy data from Phase I/II study in refractory multiple myeloma
> Initiated
Phase I/II study of daratumumab in combination with Revlimid
> Entered
partnership agreement with Janssen Biotech, Inc., one of the
Janssen Pharmaceutical Companies
Expanding Our Pipeline
> Presented
proof-of-concept for DuoBody(r) technology platform
> Presented
proof-of-concept for HuMax(r)-TF-ADC
Progressing Next Generation Technologies
> Entered
DuoBody Platform collaborations with Novartis, Janssen and Kyowa
Hakko Kirin
> Janssen
activated three DuoBody programs; achieved technical
proof-of-concept milestone o Unveiled proprietary
HexaBody(tm) technology platform
Driving Value through Collaborations
> Achieved
second and third pre-clinical milestones in Lundbeck collaboration
> Outlicensed
HuMax-IL8 to Cormorant Pharmaceuticals
x Progress on
partnered clinical programs not yet reported
Manage and Control Cash Burn
> Reduced
cash burn & lengthened cash runway
> Improved
loss from continuing operations three times
x Wrote down value
of manufacturing facility in 2012, sale executed in Q1 2013
Financial Performance
o Revenue increased by DKK 134 million, 38%,
from DKK 351 million in 2011 to DKK 485 million, mainly due to
revenue related to our daratumumab and DuoBody collaborations with
Janssen, higher Arzerra royalties, and a milestone payment from
GSK. o As the operating expenses remained at the
same level as 2011, the operating loss improved by DKK 132 million,
or 53%, from DKK 249 million in 2011 to DKK 117 million in 2012.
o Due to continued uncertainty, we wrote down the
value of the facility from USD 58 million to zero, which resulted
in the recognition of a non-cash impairment charge of approximately
DKK 331 million. o 2012 year end cash position of
DKK 1,516 million, compared to DKK 1,105 million as of December 31,
2011. The improvement was driven by the proceeds of approximately
DKK 800 million received from the daratumumab deal,partially offset
by the ongoing investment in our research and development
activities.
> = Stated objective met o = Other achievement x = Stated
objective not met
2013 OUTLOOK
MDKK |
2013 Guidance |
2012 Actual Result |
Revenue |
540 - 580 |
485 |
Operating expenses |
(600) - (650) |
(602) |
Operating loss continuing operations |
(40) - (90) |
(117) |
Discontinued operation |
40 |
(376) |
Cash position beginning of year* |
1,516 |
1,105 |
Cash used in operations |
(250) - (300) |
(389) |
Cash from license & share subscription
agreement |
- |
800 |
MN facility sale |
50 |
- |
Cash position at end of year* |
1,266 - 1,316 |
1,516 |
*Cash, cash equivalents, and
marketable securities |
Conference Call
Genmab will hold a conference call in English to discuss the
results for the full year 2012 today, Thursday, March 7, at 6:00pm
CET, 5:00pm GMT or 12:00pm EST. The dial in numbers are:
+1 866 682 8490 (US participants) and ask for the Genmab
conference call +44 1452 555131 (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 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 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. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement
nor to confirm such statements in relation to actual results,
unless required by law.
Genmab A/S and its subsidiaries own the following trademarks:
Genmab(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r);
DuoBody(r), HexaBodyTM and UniBody(r). Arzerra(r) is a trademark of
GlaxoSmithKline.
Company Announcement no. 06 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