Company Announcement
- Genmab and AbbVie entered into a broad collaboration to
jointly develop and commercialize three of Genmab’s next-generation
bispecific antibody products, including epcoritamab
- Companies establish a discovery research collaboration
to create additional differentiated antibody therapeutics for
cancer
- AbbVie to pay Genmab an upfront payment of USD 750
million with total potential milestone payments of up to USD 3.15
billion
Copenhagen, Denmark and North Chicago, Illinois; June
10, 2020 – Genmab A/S (Nasdaq: GMAB) and AbbVie Inc.
(NYSE: ABBV) announced today that Genmab and AbbVie have signed a
broad collaboration agreement to jointly develop and commercialize
three of Genmab’s early-stage investigational bispecific antibody
product candidates and enter into a discovery research
collaboration for future differentiated antibody therapeutics for
cancer. The companies will partner to develop Genmab’s
next-generation bispecific antibody programs, epcoritamab
(DuoBody®-CD3xCD20), DuoHexaBody®-CD37 and DuoBody-CD3x5T4. The
collaboration combines Genmab’s world-class discovery and
development engine and next-generation bispecific antibody
therapeutic candidates with AbbVie’s deep clinical expertise,
innovative antibody-drug conjugate (ADC) platform and global
commercial leadership in hematological cancers.
The discovery research collaboration will combine proprietary
antibodies from both companies along with Genmab’s DuoBody
technology and AbbVie’s payload and ADC technology to select and
develop up to four additional differentiated next-generation
antibody-based product candidates, potentially across both solid
tumors and hematological malignancies. Genmab’s DuoBody-CD3
technology engages and directs cytotoxic T cells selectively to
tumors to elicit an immune response towards malignant tumor cells.
AbbVie’s ADC technology allows the delivery of a therapeutic toxin
directly to cancer cells while sparing normal, healthy cells,
providing for a more targeted, less toxic treatment approach.
“This transformative collaboration will allow us to accelerate,
broaden and maximize the development of some of our promising
early-stage bispecific antibodies, including epcoritamab, with the
ultimate goal of bringing these potential therapies much faster to
cancer patients,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “Today’s announcement marks the beginning of a
new journey for Genmab that combines our world-class knowledge in
antibody biology and deep expertise in truly innovative
next-generation antibody technology platforms, with AbbVie’s
R&D prowess and their leadership position in hematological
cancers.”
“Epcoritamab is a strong fit for our robust hematological
oncology franchise”, said Michael Severino, M.D., Vice Chairman and
President, AbbVie. “By combining the strengths of our two
organizations, we can advance the treatment landscape for patients
battling cancer.”
Collaboration DetailsThis collaboration will
provide for the joint development and commercialization of the
three bispecific antibody therapeutic candidates. For epcoritamab,
the companies will share commercial responsibilities in the U.S.
and Japan, with AbbVie responsible for further global
commercialization. Genmab will book net sales in the U.S. and Japan
and receive tiered royalties on remaining global sales. For
DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates
developed as a result of the companies’ discovery research
collaboration, Genmab and AbbVie will share responsibilities for
global development and commercialization in the U.S. and Japan.
Genmab retains the right to co-commercialize these products, along
with AbbVie, outside of the U.S. and Japan. For the discovery
research partnership, Genmab will conduct Phase 1 studies for these
programs. AbbVie retains the right to opt-in to program
development.
Financial TermsUnder the terms of the
agreement, AbbVie will pay Genmab USD 750 million in upfront
payment with the potential for Genmab to receive up to USD 3.15
billion in additional development, regulatory and sales milestone
payments for all programs as well as tiered royalties between 22%
and 26% on net sales for epcoritamab outside the U.S. and Japan.
Except for these royalty-bearing sales, the parties share in
pre-tax profits from the sale of products on a 50:50 basis.
Included in these potential milestones are up to USD 1.15 billion
in payments related to clinical development and commercial success
across the three existing bispecific antibody programs. In
addition, if all four next-generation antibody product candidates
developed as a result of the discovery research collaboration are
successful, Genmab is eligible to receive up to USD 2.0 billion in
option exercise and success-based milestone payments.
As a result of this agreement, Genmab is improving its financial
guidance for 2020.
OUTLOOK
(DKK million) |
Revised Guidance |
Previous Guidance |
Revenue |
9,100 - 9,500 |
4,750 - 5,150 |
Operating expenses |
(3,850) - (3,950) |
(3,850) - (3,950) |
Operating income |
5,200 - 5,600 |
850 - 1,250 |
RevenueWe expect our 2020 revenue to be in the
range of DKK 9,100 - DKK 9,500 million, an increase of DKK 4,350
million compared to our previous guidance. The increase is due to
nearly 90% of the USD 750 million upfront payment from this
agreement being recognized immediately with the remainder being
recognized over a number of years. The other elements of our
original revenue guidance remain unchanged and are primarily
related to DARZALEX royalties of DKK 4,075 – 4,475 million. Such
royalties are based on estimated DARZALEX net sales of USD 3.9 –
4.2 billion. We project cost reimbursement income of approximately
DKK 475 million which is related to our collaborations with Seattle
Genetics and BioNTech. The remainder of our revenue is
approximately DKK 200 million and consists of milestones and other
royalties.
Operating ExpensesWe anticipate our 2020
operating expenses will continue to be in the range of DKK 3,850 –
3,950 million. From the execution date of the agreement, our
operating costs will include 50% of the costs for epcoritamab,
DuoHexaBody-CD37 and DuoBody-CD3x5T4 and 100% of the costs for the
discovery research collaboration. We expect that the reduction in
our operating costs due to partner contribution to the existing
clinical programs will be offset by increased investment to further
expand and accelerate the partnership programs.
Operating ResultWe now expect our operating
income to be approximately DKK 5,200 to DKK 5,600 million in
2020.
In addition to factors already mentioned, the estimates above
are subject to change due to numerous reasons, including but not
limited to the achievement of certain milestones associated with
our collaboration agreements; the timing and variation of
development activities (including activities carried out by our
collaboration partners) and related income and costs; DARZALEX
sales and corresponding royalties to Genmab; and currency exchange
rates (the 2020 guidance assumes a USD/DKK exchange rate of 6.5).
The financial guidance assumes that no significant new agreements
are entered into during 2020 that could materially affect the
results. Conference CallGenmab will hold a
conference call in English to discuss this news today, Wednesday,
June 10, 2020, at 6:00 AM CDT / 7:00 AM EDT / 1:00 PM CEST. The
dial in numbers are:
+1 855 857 0686 (US participants) +44 3333000804 (international
participants)
Confirmation code: 48035919
A live and archived webcast of the call and relevant slides will
be available at www.genmab.com.
About Epcoritamab (DuoBody-CD3xCD20)Epcoritamab
(DuoBody-CD3xCD20) is a bispecific antibody created using Genmab’s
proprietary DuoBody technology. Epcoritamab is designed to target
CD3, which is expressed on T cells and is part of the T cell
receptor signaling complex, and CD20, a clinically well validated
therapeutic target. CD20 is expressed on a majority of B cell
malignancies, including chronic lymphocytic leukemia (CLL), diffuse
large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle
cell lymphoma (MCL). In a number of laboratory models, epcoritamab
has shown highly effective killing of CD20+ tumors and induced
potent tumor cell lysis across a panel of B cell tumor lines.
Epcoritamab is currently evaluated in a Phase 1/2 study for
multiple hematological B cell malignancies.
Complete dose escalation data for epcoritamab was presented at
the American Society of Clinical Oncology 2020 (ASCO20) Virtual
Scientific Program. The data and preliminary activity from the
Phase 1/2 study of subcutaneous epcoritamab in patients with
relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL) are
highly encouraging showing substantial single-agent activity for
epcoritamab with a manageable safety profile. In the study,
epcoritamab induced rapid and deep responses in heavily pretreated
patients with B-NHL across different subtypes and no dose-limiting
toxicities were observed.
About Genmab 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 is the creator of
three approved antibodies: DARZALEX® (daratumumab, under agreement
with Janssen Biotech, Inc.) for the treatment of certain multiple
myeloma indications in territories including the U.S., Europe and
Japan, Arzerra® (ofatumumab, under agreement with Novartis AG), for
the treatment of certain chronic lymphocytic leukemia indications
in the U.S., Japan and certain other territories and TEPEZZA™
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, DARZALEX
FASPRO™ (daratumumab and hyaluronidase-fihj), has been approved in
the U.S. for the treatment of adult patients with certain multiple
myeloma indications. Daratumumab is in clinical development by
Janssen for the treatment of additional multiple myeloma
indications, other blood cancers and amyloidosis. A subcutaneous
formulation of ofatumumab is in development by Novartis for the
treatment of relapsing multiple sclerosis. 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, the HexaBody® platform, which creates effector function
enhanced antibodies, the HexElect® platform, which combines two
co-dependently acting HexaBody molecules to introduce selectivity
while maximizing therapeutic potency and the DuoHexaBody® platform,
which enhances the potential potency of bispecific antibodies
through hexamerization. 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. Genmab is headquartered in Copenhagen,
Denmark with sites in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan.
About AbbVieAbbVie’s mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people’s lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women’s health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Contacts for Genmab: Marisol Peron,
Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior Director,
Investor RelationsT: +45 3377 9558; E: acn@genmab.com
Contacts for AbbVie:Media: Adelle
Infante847-938-8745Adelle.infante@abbvie.com
Investors:Liz Shea847-935-2211Liz.shea@abbvie.com
Forward-Looking Statements for GenmabThis 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 or technologies 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 www.genmab.com and the
risk factors included in Genmab’s most recent Annual Report on Form
20-F and other filings with the U.S. Securities and Exchange
Commission (SEC), which are available at www.sec.gov. Genmab does
not undertake any obligation to update or revise forward looking
statements in this Company Announcement nor to confirm such
statements to reflect subsequent events or circumstances after the
date made or in relation to actual results, unless required by
law.
Forward-Looking Statements for AbbVie Some
statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words “believe,”“expect,”
“anticipate,” “project” and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie’s acquisition of Allergan
plc (“Allergan”), failure to promptly and effectively integrate
Allergan’s businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, “Risk Factors,” of
AbbVie's 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law. Genmab A/S and/or its subsidiaries own the
following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in
combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®;
DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody
in combination with the HexaBody logo®; DuoHexaBody®; HexElect®;
and UniBody®. Arzerra® is a trademark of Novartis AG or its
affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of
Janssen Pharmaceutica NV. TEPEZZA™ is a trademark of Horizon
Therapeutics plc.
Company Announcement no. 25CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 100620_CA25_Genmab_AbbVie
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