Genmab A/S Tel: +45 7020 2728 Company Announcement no. 21
Bredgade 34E Fax: +45 7020 2729 Page 1/32
1260 Copenhagen K, Denmark http://www.genmab.com" onclick="window.open(this.href);return false; CVR no. 2102 3884
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
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.
http://www.genmab.com/docs/default-sour ... f?sfvrsn=2" onclick="window.open(this.href);return false;
http://www.econotimes.com/Genmab-Announ ... oma-211608" onclick="window.open(this.href);return false;
BRIEF-Genmab: Breakthrough Therapy Designation for Daratumumab
Genmab A/S :
* Daratumumab receives Breakthrough Therapy Designation in combination with standard of care regimens for multiple myeloma patients who have received at least one prior line of therapy
* Potential for accelerated review
* Daratumumab is being developed by Janssen Biotech, Inc. under exclusive worldwide license
• New commercial DuoBody technology platform collaboration with Gilead
• Genmab granted Gilead an exclusive license to create a bispecific antibody with the DuoBody technology and an option to obtain a second exclusive license
Copenhagen, Denmark; August 10, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody® technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab will receive an upfront payment of USD 5 million from Gilead Sciences.
Genmab is entitled to potential development, regulatory and sales milestones of up to USD 277 million for the first product and further milestones for subsequent products. In addition, Genmab will be entitled to single-digit royalties on Gilead's sales of any commercialized products. Similar terms would apply if Gilead exercises the option to the second license.
"We are pleased to add this agreement with Gilead to our growing list of commercial collaborations for our innovative DuoBody platform and we are particularly excited that the potential for DuoBody bispecific antibodies for treating HIV will be explored," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
This commercial license agreement follows a research collaboration between Genmab and Gilead Sciences for the DuoBody technology signed in 2014.
This agreement is not expected to have a material impact on Genmab's 2016 financial guidance.
About the DuoBody Platform
The DuoBody platform is an innovative platform for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer, autoimmune, infectious and central nervous system disease. Bispecific antibodies bind to two different epitopes either on the same, or on different targets (also known as dual-targeting) which may improve the antibodies' specificity and efficacy in inactivating the disease targets. DuoBody molecules are unique in combining the benefits of bispecificity with the strengths of conventional antibodies which allows DuoBody molecules to be administered and dosed as other antibody therapeutics. Genmab's DuoBody platform generates bispecific antibodies via a fast and broadly applicable process which is easily performed at standard bench, as well as commercial, manufacturing scale.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin's lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit http://www.genmab.com" onclick="window.open(this.href);return false;.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.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 http://www.genmab.com" onclick="window.open(this.href);return false;. 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®; 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.
Company Announcement no. 33
CVR no. 2102 3884
1260 Copenhagen K
Genmab Announces Financial Results for the First Nine Months of 2016 and Improves 2016 Financial Guidance
Interim Report for the Nine Months Ended September 30, 2016
November 2, 2016; Copenhagen, Denmark;
Interim Report for First Nine Months Ended September 30, 2016
• Net Sales of DARZALEX® (daratumumab) by Janssen for the first nine months of 2016 were USD 372 million, resulting in royalty income of USD 45 million (DKK 298 million)
• Announced U.S. and European regulatory submissions for daratumumab in relapsed or refractory multiple myeloma, triggering USD 25 million in milestone payments
• Daratumumab received second Breakthrough Therapy Designation from U.S. Food and Drug Administration (FDA)
• Announced FDA approval of Arzerra® (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed chronic lymphocytic leukemia (CLL)
• Entered commercial license agreement with Gilead Sciences for DuoBody® Technology
• 2016 financial guidance improved
"Throughout the third quarter we continued to see excellent progress in our DARZALEX program with Janssen. Regulatory applications to expand the label for daratumumab to include relapsed or refractory multiple myeloma were submitted in the U.S. and Europe, triggering USD 25 million in milestone payments. Daratumumab also received its second Breakthrough Therapy Designation from the FDA. We continued to see progress with Arzerra too, with another CLL indication approved in the U.S., and we made progress with our DuoBody technology, with a new commercial agreement with Gilead Sciences," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
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