COPENHAGEN K, Denmark, May 10, 2016 (GLOBE NEWSWIRE) -- Interim Report for the First Quarter of 2016
- Net Sales of DARZALEX(r) (daratumumab) by Janssen for the first quarter of 2016 were USD 101.9 million,
resulting in royalty income of DKK 83 million
- Announced positive interim result in Phase III Castor study of daratumumab in relapsed or refractory multiple
myeloma
- Announced studies of daratumumab in combination with atezolizumab in a solid tumor and multiple myeloma
- Achieved USD 5 million milestone for progress in the Phase II study of daratumumab in non-Hodgkin's lymphoma (NHL)
under collaboration with Janssen
- Announced updated development plans for ofatumumab in autoimmune indications
- U.S. Food and Drug Administration (FDA) Approval of Arzerra(r) (ofatumumab) as extended treatment for
recurrent or progressive chronic lymphocytic leukemia (CLL)
- U.S. and EU regulatory submissions for ofatumumab in combination with fludarabine and cyclophosphamide for relapsed
CLL
"The first quarter of 2016 saw continued rapid progress in the development of daratumumab with Janssen: We reported positive
interim data in the Phase III Castor study of daratumumab in combination with bortezomib and dexamethasone, achieved the second
milestone in the Phase II NHL study, and announced the first study to combine daratumumab with Roche's anti-PDL1 antibody
atezolizumab, in a solid tumor and multiple myeloma. We also started off the year with a number of achievements under our Arzerra
collaboration with Novartis. Arzerra was approved in the U.S. as extended treatment for recurrent or progressive CLL and
regulatory submissions for ofatumumab in combination with fludarabine and cyclophosamide in relapsed CLL were submitted in the U.S.
and Europe. Furthermore, we announced that development of the subcutaneous formulation of ofatumumab in autoimmune indications will
be focused on relapsing multiple sclerosis, with large Phase III studies run by Novartis expected to start later this year," said
Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter
- Revenue was DKK 170 million in the first quarter of 2016 compared to DKK 107 million in the first quarter of 2015. The
increase of DKK 63 million, or 59%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration
with Janssen.
- Operating expenses were DKK 154 million in the first quarter of 2016 compared to DKK 110 million in the first quarter of
2015. The increase of DKK 44 million, or 40%, was due to the additional investment in our pipeline of products, including the
advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
- Operating income was DKK 16 million in the first quarter of 2016 compared to DKK 173 million in the first quarter of
2015. The decrease of DKK 157 million was driven by the one-time reversal of the ofatumumab funding liability of DKK 176
million in 2015 combined with increased operating expenses, which were partly offset by higher revenue.
- On March 31, 2016, Genmab had a cash position of DKK 3,491 million, similar to the cash position of DKK 3,493 million at
December 31, 2015.
Business Progress First Quarter to Present
Daratumumab
- March: Announced that the Phase III Castor study (MMY3004) of daratumumab in combination with bortezomib and dexamethasone
versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of
improving progression free survival (PFS) in a planned interim analysis (p<0.0001). Janssen will engage in a dialogue with the
health authorities about the potential for these data to serve as the basis for a regulatory submission.
- March: Announced that daratumumab will be investigated in Phase Ib clinical studies in combination with atezolizumab, an
anti-PD-L1 antibody, in a solid tumor and multiple myeloma. The studies will be conducted under a collaboration agreement between
Janssen Biotech, Inc. (Janssen) and Genentech, a member of the Roche Group.
- March: Achieved the second milestone in the ongoing Phase II study of daratumumab in NHL, triggering a USD 5 million payment
from Janssen.
Ofatumumab
- March: Announced that supplemental regulatory applications for the use of Arzerra in combination with fludarabine and
cyclophosphamide for the treatment of patients with relapsed CLL were submitted in the U.S. and EU by Novartis.
- March: Announced an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple
sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the
end of 2015. Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis are expected to be
initiated by Novartis during the second half of 2016. The Phase III study of the subcutaneous formulation of ofatumumab in
pemphigus vulgaris, which was started by GSK, will be discontinued.
- January: The U.S. FDA approved a supplemental Biologics License Application (sBLA) for the use of Arzerra for extended
treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive
CLL.
Subsequent Events
- April: Reported additional data from the Phase III Castor study of daratumumab in combination with bortezomib and
dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met
the primary endpoint of improving PFS; Hazard Ratio (HR) = 0.39, p<0.0001. The median PFS for patients treated with
daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab. Data from
this study was accepted for oral presentation in a Plenary Session at the 2016 American Society of Clinical Oncology (ASCO)
Annual Meeting.
- April: Announced that MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Genmab's
collaboration partner Janssen, for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the
manufacture, use and sale of DARZALEX in the United States. Genmab and Janssen disagree with the allegations made by MorphoSys in
its complaint for patent infringement related to CD38 antibodies and intend to vigorously contest those allegations.
- April: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive
opinion recommending the granting of a conditional marketing authorization for DARZALEX intended for the treatment of relapsed
and refractory multiple myeloma. The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients
with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory
agent and who have demonstrated disease progression on the last therapy.
Outlook
Genmab is maintaining its 2016 revised financial guidance published on April 20, 2016.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2016 today, Tuesday, May 10, at 6.00
pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:
+1 212 444 0412 (US participants) and ask for the Genmab conference call
+44 20 3427 1917 (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: r.gravesen@genmab.com
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(r); the Y-shaped Genmab logo(r); Genmab in combination with
the Y-shaped Genmab logo(tm); the DuoBody logo(r); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(r) and
UniBody(r). Arzerra(r) is a trademark of Novartis AG or its affiliates. DARZALEX(r) is a trademark of Janssen Biotech, Inc.
Download the full Interim Report for the first quarter of 2016 on attachment or at www.genmab.com.
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
