Company Announcement
- Genmab licenses daratumumab to Janssen Biotech, Inc.,
one of the Janssen Pharmaceutical Companies of Johnson &
Johnson
- $55 million upfront payment to Genmab
- Johnson & Johnson Development Corporation invests
DKK 475 million (approx. $80 million) in new Genmab
shares
- Total potential agreement value including upfront
payment, equity investment and milestones in excess of $1.1
billion
COPENHAGEN, Denmark, Aug. 30, 2012 (GLOBE NEWSWIRE)
-- Genmab A/S (Copenhagen:GEN)
announced today a global license and development agreement
for daratumumab (HuMax(r)-CD38), a human CD38 monoclonal antibody
with Janssen Biotech, Inc., one of the Janssen Pharmaceutical
Companies of Johnson & Johnson (Janssen). Daratumumab
is currently in development for multiple myeloma and may have
potential in other cancer indications such as acute myeloid
leukemia. Under the terms of the agreement, Genmab will grant
Janssen an exclusive worldwide license to develop and commercialize
daratumumab as well as a backup human CD38 antibody.
Under the terms of the agreement, Genmab will receive an upfront
license fee of $55 million (approximately DKK 327 million) and
Johnson & Johnson Development Corporation (JJDC) will invest
DKK 475 million, (approximately $80 million) to subscribe for 5.4
million new shares of Genmab at a price of DKK 88 per share.
Genmab's closing share price on August 29, 2012 was DKK 67.85.
Genmab could also be entitled to up to $1 billion in development,
regulatory and sales milestones, in addition to tiered double digit
royalties. Janssen will be fully responsible for all costs
associated with developing and commercializing daratumumab going
forward, including the costs of two ongoing Phase I/II studies.
"Janssen was one of the first companies to recognize the power
and promise of monoclonal antibodies and today is a world leader in
biologics; we look forward to applying that same expertise to
daratumumab to help meet the needs of patients with multiple
myeloma," said William N. Hait, M.D., Ph.D., Head of Janssen
Research & Development, LLC. "Daratumumab is an exciting,
innovative compound, and we are delighted to add it to our
portfolio."
"We are very pleased to partner with Janssen on another Genmab
innovation and look forward to working with them to accelerate the
development of daratumumab and to maximize the value of this
product," said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab. "This agreement significantly strengthens our
financial position, ensuring that Genmab can continue to develop
much needed differentiated antibody therapeutics to help cancer
patients in the future."
The transaction is subject to customary closing conditions,
including approval of a prospectus by the Danish Financial
Supervisory Authority and clearance by the US antitrust authorities
under the Hart-Scott-Rodino Act, and will become final as soon as
these conditions have been met.
OUTLOOK
MDKK |
Revised
Guidance** August 30, 2012 |
Previous
Guidance August 15, 2012 |
Revenue |
435 - 460 |
375 - 400 |
Operating expenses |
(600) - (625) |
(600) - (625) |
Operating loss continuing operations |
(140) - (190) |
(200) - (250) |
Discontinued operation |
(40) |
(40) |
Cash position beginning of year* |
1,105 |
1,105 |
Cash used in operations |
(375) - (400) |
(375) - (400) |
Cash from license agreement & share
subscription agreement |
800 |
- |
Cash position at end of year* excl. MN sale |
1,505 - 1,530 |
705 - 730 |
Facility sale |
320 |
320 |
Cash position at end of
year* |
1,825 - 1,850 |
1,025 - 1,050 |
*Cash, cash equivalents, and
marketable securities **Dependent on closing of the transaction
with Janssen and JJDC |
Continuing Operations
We expect our 2012 revenue to now be in the range of DKK 435 -
460 million, an improvement of DKK 60 million from the previous DKK
375 - 400 million. The increased revenue is primarily due to the
daratumumab license agreement and share subscription agreement
entered into with Janssen and JJDC, respectively. The agreements
include reimbursement of certain research and development costs and
the amortization of the upfront payment and a part of the share
premium which initially is recognized as deferred income and
allocated as revenue over a number of years.
Our revenue consists primarily of non-cash amortization of
deferred revenue totaling DKK 250 million (previous guidance was
DKK 230 million) and royalties on sales of Arzerra, which still are
expected to be in the range of DKK 90 - 100 million. We anticipate
that our 2012 operating expenses from continuing operations will
remain the same as the previous guidance at DKK 600 - 625 million.
With the increase in revenue and no change to the operating expense
guidance, the operating loss also improves. We expect the operating
loss from continuing operations for 2012 to be approximately DKK
140 - 190 million, an improvement of DKK 60 million over the
previous guidance of DKK 200 - 250 million. Discontinued
Operation
The discontinued operation guidance of DKK 40 million relates to
the ongoing running costs of maintaining the Minnesota
manufacturing facility in a validated state and represents a full
12 months of activity. This expense could be lower if the facility
is sold before the end of the year. The fair value of the facility
less cost to sell is currently estimated to be USD 58 million,
approximately DKK 320 million at an assumed exchange rate of USD
1.00 = DKK 5.50. As of August 29, 2012, the exchange rate between
USD and DKK was 5.9388. We remain focused on entering a sales
agreement and anticipate the sale of the facility in 2012.
Cash Position
As of December 31, 2011, we had a cash position of DKK 1,105
million and are still projecting a cash burn from operations in
2012 of DKK 375 - 400 million as the reimbursement of certain
research and development costs under the daratumumab license
agreement will be received in early 2013. We are now projecting a
cash position at the end of 2012, excluding the facility sale, of
DKK 1,505 - 1,530 million, an increase of DKK 800 million compared
to the previous guidance of DKK 705 - 730 million. The improvement
is due to the equity investment and upfront payment related to the
daratumumab license agreement and share subscription agreement.
Taking into account the planned sale of the facility, the projected
cash position at the end of 2012 would increase by DKK 320 million
to DKK 1,825 - 1,850 million, compared to the previous guidance of
DKK 1,025 - 1,050 million. In addition to factors already
mentioned, the estimates above are subject to change for numerous
reasons, including but not limited to, closing of the transaction
with Janssen and JJDC, the timing and variation of development
activities (including activities carried out by our collaboration
partners) and related income and costs; the successful completion
of the manufacturing facility sale; fluctuations in the value of
our marketable securities; Arzerra sales and corresponding
royalties to Genmab; and currency exchange rates. The financial
guidance also assumes that no significant new agreements are
entered into during 2012 that could materially affect the
results.
Conference Call
Genmab will hold a conference call in English to discuss this
news today, Thursday August 30, 2012, at 9:00 am CEST, 08:00 am BST
(3:00 am EDT). The dial in numbers are:
+1 718 354 1226 (US participants) and ask for the Genmab
conference call
+44 207 509 5139 (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.
About daratumumab
Daratumumab is a human CD38 monoclonal antibody with
broad-spectrum killing activity. Daratumumab is in clinical
development for multiple myeloma (MM). Daratumumab targets the CD38
molecule which is highly expressed on the surface of multiple
myeloma cells. Daratumumab could also have potential in other
tumors on which CD38 is expressed.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company
specializing in the creation and development of differentiated
human antibody therapeutics for the treatment of cancer. Founded in
1999, the company's first marketed antibody, ofatumumab
(Arzerra(r)), was approved to treat chronic lymphocytic leukemia in
patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next
generation antibody technologies are expected to provide a steady
stream of future product candidates. Partnering of innovative
product candidates and technologies is a key focus of Genmab's
strategy and the company has alliances with top tier pharmaceutical
and biotechnology companies. For more information visit
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
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
www.genmab.com. 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(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R);
HuMax(R)-EGFr; HuMax(R)-IL8; HuMax(R)-TAC; HuMax(R)-CD38;
HuMax(R)-TF; HuMax(R)-TF-ADC; HuMax(R)-Her2; HuMax(R)-cMet,
HuMax(R)-CD74, DuoBody(TM) and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(R) is a trademark of GlaxoSmithKline.
Company Announcement no. 20 CVR no. 2102 3884
Genmab A/S Bredgade 34 1260 Copenhagen K Denmark