DGAP-News: Genmab 2012 Annual Report
(firmenpresse) - Genmab A/S
07.03.2013 17:02
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Company Announcement
Copenhagen, Denmark; March 7, 2013 - Genmab A/S (OMX: 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 2012 Actual
Guidance Result
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Revenue 540 - 580 485
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Operating expenses (600) - (602)
(650)
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Operating loss continuing operations (40) - (90) (117)
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Discontinued operation 40 (376)
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Cash position beginning of year* 1,516 1,105
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Cash used in operations (250) - (389)
(300)
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Cash from license&share subscription - 800
agreement
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MN facility sale 50 -
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Cash position at end of year* 1,266 - 1,516
1,316
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*Cash, cash equivalents, and marketable securities
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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.
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(at)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), HexaBody(TM) 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
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Language: English
Company: Genmab A/S
Dänemark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service
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Datum: 07.03.2013 - 17:02 Uhr
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