Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Genmab Interim / Quarterly Report 2016

May 10, 2016

Preview isn't available for this file type.

Download source file

May 10, 2016; Copenhagen, Denmark;
Interim Report for the First Quarter of 2016

-- Net Sales of DARZALEX® (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® (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: [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 AG or its affiliates.
DARZALEX® 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