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Genmab — Interim / Quarterly Report 2015
Aug 11, 2015
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Download source fileAugust 11, 2015; Copenhagen, Denmark;
Interim Report First Half 2015
-- Rolling submission of BLA to U.S. FDA for daratumumab in double refractory
multiple myeloma completed by Janssen, triggering a USD 15 million
milestone payment
-- Regulatory submissions for ofatumumab (Arzerra®) as maintenance therapy for
relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the
EMA and FDA
-- Achieved USD 10 million milestone payment under daratumumab collaboration
with Janssen for progress in Phase III study (“Alcyone” MMY3007)
-- Positive top-line results from the Phase III COMPLEMENT 2 study of
ofatumumab plus fludarabine and cyclophosphamide in relapsed CLL
-- Entered commercial agreement for DuoBody® platform with BioNTech in the
field of immuno-oncology
-- Improved operating result by DKK 147 million over the first half of 2014
“During the second quarter we continued to see steady advances in our two most
advanced programs, daratumumab and ofatumumab. The daratumumab program
continues to progress very rapidly with the first regulatory application
submitted in the U.S. by Janssen Biotech, Inc. under our collaboration.
Together with Novartis, we reported positive top-line results in a pivotal
study of ofatumumab in combination with fludarabine and cyclophosphamide in
relapsed CLL; the data will be shared with the regulatory authorities to
determine the potential for regulatory filings. Regulatory submissions for
ofatumumab as maintenance therapy in relapsed CLL were submitted by Novartis to
the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)
in July. We also continue to focus on our technologies and effectively progress
a robust early stage pipeline, having entered an agreement with BioNTech for
the DuoBody platform in the field of immuno-oncology and obtaining a license
from Bristol-Myers Squibb for antibodies targeting CD19,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
-- Revenue was DKK 281 million in the first half of 2015 compared to DKK 363
million in the first half of 2014. The decrease of DKK 82 million or 23%
was mainly driven by lower milestone revenue under our daratumumab
collaboration with Janssen.
-- Operating expenses were DKK 244 million in the first half of 2015 compared
to DKK 298 million in the first half of 2014. The decrease of DKK 54
million or 18% was primarily related to a decrease in costs associated with
the ofatumumab and daratumumab programs, which was partly offset by
increased investment in our research and technology platforms.
-- Operating income was DKK 212 million in the first half of 2015 compared to
DKK 65 million in the first half of 2014. The improvement of DKK 147
million was driven by the income from reversal of the ofatumumab funding
liability of DKK 176 million combined with lower expenses, which were
partly offset by decreased revenue.
-- On June 30, 2015, Genmab had a cash position of DKK 2,958 million. This
represented a net increase of DKK 297 million from December 31, 2014, which
was driven primarily by the proceeds from exercise of warrants of DKK 478
million partly offset by the increased investment in our research and
development activities to advance our pipeline of products.
Business Progress Second Quarter to Present
-- July: The rolling submission of a Biologics License Application (BLA) to
the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15
million milestone payment to Genmab. The initiation of the rolling
submission was announced in June. (Genmab granted Janssen an exclusive
worldwide license to develop, manufacture and commercialize daratumumab in
2012.)
-- July: Announced that regulatory applications were submitted to the EMA and
FDA for the use of ofatumumab as maintenance therapy of patients with
relapsed CLL by Novartis.
-- June: Entered an agreement for an exclusive license from Bristol-Myers
Squibb to a panel of human antibodies targeting CD19.
-- May: Entered an agreement with BioNTech AG to jointly research, develop and
commercialize bispecific antibody products within the field of
immuno-oncology using the DuoBody technology platform.
-- May: Presented first preliminary clinical data from the ongoing Phase I
study of HuMax®-TF-ADC in solid tumors, showing that HuMax-TF-ADC can be
dosed safely in therapeutically meaningful doses and with encouraging early
signs of efficacy.
-- April: Announced positive top-line results from the Phase III COMPLEMENT 2
study which showed that treatment with Arzerra plus fludarabine and
cyclophosphamide met the primary endpoint of improved progression-free
survival (PFS) in patients with relapsed CLL (HR 0.67, p = 0.0032) compared
to those given fludarabine and cyclophosphamide alone. The data will be
shared with the US and EU regulatory agencies to evaluate the potential for
future regulatory filings.
-- April: Achieved a USD 10 million milestone payment in the daratumumab
collaboration with Janssen for progress in the ongoing Phase III study
(“Alcyone” MMY3007) which compares daratumumab in combination with
bortezomib, melphalan and prednisone (VMP) to VMP alone as front line
treatment for multiple myeloma patients who are not considered candidates
for stem cell transplantation.
Outlook
Genmab is maintaining its updated 2015 financial guidance published on May 20,
2015.
Conference Call
Genmab will hold a conference call in English to discuss the results for the
first half of 2015 today, Tuesday, August 11, at 6.00 pm CEST, 5.00 pm BST or
noon EDT. The dial in numbers are:
+1 646 254 3363 (US participants) and ask for the Genmab conference call
+44 20 3427 1914 (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.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]
The 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 the
interim report. Genmab does not undertake any obligation to update or revise
forward looking statements in the interim report 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®; the
Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™;
the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody®
and UniBody®. Arzerra® is a trademark of Novartis Pharma AG.
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
Download the full Interim Report for the first half of 2015 on attachment or at
www.genmab.com.