Genmab Announces Financial Results for the First Quarter 2012
Genmab A/S
15.05.2012 17:01
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May 15, 2012; Copenhagen, Denmark;
Interim Report for the First Quarter 2012
-- Arzerra(r) net sales increased 32% over Q1 2011
-- New Drug Application for ofatumumab submitted in Japan
-- Amended protocol for ofatumumab Phase III head to head study vs rituximab
in DLBCL; moved estimated primary data readout forward
-- Improved operating result year on year due to lower operating expenses and
increased revenues
'We have achieved a number of business milestones during the last months
including the filing of the New Drug Application (NDA) in Japan for ofatumumab
and another milestone in our Lundbeck collaboration. We also continue to focus
on resources and in the first quarter of the year we have improved the
operating result and lowered operating expenses compared to the same period
last year,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
-- Genmab's revenues were DKK 94 million for the first quarter of 2012
compared to DKK 83 million for the corresponding period in 2011. The
increase was mainly driven by higher Arzerra(r) royalties and the inclusion
of one milestone under our collaboration with Lundbeck.
-- Operating expenses decreased 5% from DKK 145 million in the first quarter
of 2011 to DKK 138 million in the first quarter of 2012.
-- An operating loss of DKK 44 million in the first quarter of 2012 compared
to DKK 62 million in the corresponding period for 2011. The improved
operating result was driven by increased revenues, and continued strong
focus on cost control.
-- On March 31, 2012, Genmab had a cash position of DKK 1,030 million
resulting in a cash burn of DKK 74 million in the first quarter of 2012.
This was a reduction of DKK 20 million compared to the corresponding period
in 2011.
Business Progress First Quarter to Present
-- February: Achieved second preclinical milestone in Lundbeck collaboration,
triggering EUR 1 million payment to Genmab.
-- March: Announced submission of protocol amendment for ofatumumab Phase III
head to head study vs rituximab in diffuse large B-cell lymphoma (DLBCL).
Estimate for primary data readout moved forward.
-- March:
Announced that GlaxoSmithKline (GSK) had entered a settlement resolving all
litigation related to ofatumumab under both the Cabilly II and the Cabilly
III patent.
-- April: GSK reported net sales for Arzerra for the first quarter of 2012 of
GBP 12.4 million, resulting in royalty income of DKK 22 million to Genmab.
-- April: GSK submitted a NDA for ofatumumab to regulatory authorities in
Japan for the treatment of patients with chronic lymphocytic leukemia (CLL)
who have received prior treatment.
Outlook
Genmab is maintaining its 2012 financial guidance as announced on March 7, 2012.
Conference Call
Genmab will hold a conference call in English to discuss the results for the
first quarter of 2012 today, Tuesday, May 15, at 6.00 pm CEST, 5.00 pm BST or
noon EDT. The dial in numbers are:
+1 718 354 1226 (US participants) and ask for the Genmab conference call
+44 207 509 5139 (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.
To read the full PDF version of the Interim Report for the First Quarter 2012,
visit Genmab's website at http://ir.genmab.com/annuals.cfm.
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@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); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr;
HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-TF-ADC; HuMax(r)-Her2;
HuMax(r)-cMet, HuMax(r)-CD74, DuoBody(tm) and UniBody(r) are all trademarks of Genmab
A/S. Arzerra(r) is a trademark of GlaxoSmithKline.
Company Announcement no. 14
CVR no. 2102 3884
Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark
Click on, or paste the following link into your web browser, to view the associated documents
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=392869
News Source: NASDAQ OMX
15.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genmab A/S
DÀnemark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Genmab A/S
15.05.2012 17:01
---------------------------------------------------------------------------
May 15, 2012; Copenhagen, Denmark;
Interim Report for the First Quarter 2012
-- Arzerra(r) net sales increased 32% over Q1 2011
-- New Drug Application for ofatumumab submitted in Japan
-- Amended protocol for ofatumumab Phase III head to head study vs rituximab
in DLBCL; moved estimated primary data readout forward
-- Improved operating result year on year due to lower operating expenses and
increased revenues
'We have achieved a number of business milestones during the last months
including the filing of the New Drug Application (NDA) in Japan for ofatumumab
and another milestone in our Lundbeck collaboration. We also continue to focus
on resources and in the first quarter of the year we have improved the
operating result and lowered operating expenses compared to the same period
last year,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
-- Genmab's revenues were DKK 94 million for the first quarter of 2012
compared to DKK 83 million for the corresponding period in 2011. The
increase was mainly driven by higher Arzerra(r) royalties and the inclusion
of one milestone under our collaboration with Lundbeck.
-- Operating expenses decreased 5% from DKK 145 million in the first quarter
of 2011 to DKK 138 million in the first quarter of 2012.
-- An operating loss of DKK 44 million in the first quarter of 2012 compared
to DKK 62 million in the corresponding period for 2011. The improved
operating result was driven by increased revenues, and continued strong
focus on cost control.
-- On March 31, 2012, Genmab had a cash position of DKK 1,030 million
resulting in a cash burn of DKK 74 million in the first quarter of 2012.
This was a reduction of DKK 20 million compared to the corresponding period
in 2011.
Business Progress First Quarter to Present
-- February: Achieved second preclinical milestone in Lundbeck collaboration,
triggering EUR 1 million payment to Genmab.
-- March: Announced submission of protocol amendment for ofatumumab Phase III
head to head study vs rituximab in diffuse large B-cell lymphoma (DLBCL).
Estimate for primary data readout moved forward.
-- March:
Announced that GlaxoSmithKline (GSK) had entered a settlement resolving all
litigation related to ofatumumab under both the Cabilly II and the Cabilly
III patent.
-- April: GSK reported net sales for Arzerra for the first quarter of 2012 of
GBP 12.4 million, resulting in royalty income of DKK 22 million to Genmab.
-- April: GSK submitted a NDA for ofatumumab to regulatory authorities in
Japan for the treatment of patients with chronic lymphocytic leukemia (CLL)
who have received prior treatment.
Outlook
Genmab is maintaining its 2012 financial guidance as announced on March 7, 2012.
Conference Call
Genmab will hold a conference call in English to discuss the results for the
first quarter of 2012 today, Tuesday, May 15, at 6.00 pm CEST, 5.00 pm BST or
noon EDT. The dial in numbers are:
+1 718 354 1226 (US participants) and ask for the Genmab conference call
+44 207 509 5139 (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.
To read the full PDF version of the Interim Report for the First Quarter 2012,
visit Genmab's website at http://ir.genmab.com/annuals.cfm.
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@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); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr;
HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-TF-ADC; HuMax(r)-Her2;
HuMax(r)-cMet, HuMax(r)-CD74, DuoBody(tm) and UniBody(r) are all trademarks of Genmab
A/S. Arzerra(r) is a trademark of GlaxoSmithKline.
Company Announcement no. 14
CVR no. 2102 3884
Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark
Click on, or paste the following link into your web browser, to view the associated documents
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=392869
News Source: NASDAQ OMX
15.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genmab A/S
DÀnemark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service
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