Company Anticipates No Impact on U.S. and
European Royalty Revenues from DARZALEX
FASPRO® and SC through at least 2030
Reiterates 2023 Revenue Guidance of
$815 million to $845 million and Royalty Revenue of $445 million to $455 million
SAN
DIEGO, March 15, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today provides an
update on a decision by the Opposition Division of the European
Patent Office ("EPO") regarding one of the Janssen Biotech, Inc.
(Janssen) co-formulation patents for DARZALEX®
(daratumumab) SC.
"We remain confident in our strong royalty revenue potential
across our diverse partner pipeline. Today's decision in
Europe on a single co-formulation
patent has no impact on our current full year 2023 revenue
guidance. Janssen will continue to pay royalties to Halozyme on
U.S. and European sales of DARZALEX FASPRO® and SC, in
line with our total royalty revenue projection of approximately
$1 billion by 2027, and thereafter to
at least 2030. We also do not believe this decision will impact the
ability of any other Halozyme licensee to obtain co-formulation
patents for their innovations. Furthermore, today's decision has no
impact on the composition of matter patents in the U.S. and
Europe for ENHANZE®,"
said Dr. Helen Torley, president and
chief executive officer of Halozyme.
"We are disappointed with the Opposition Division's oral
decision to revoke Janssen's European Patent EP3370770B1. We
expect a written decision to be provided in the next several
months. If an appeal is filed, it would suspend today's decision
and the patent would remain in force until the case is finally
decided on any such appeal," concluded Dr. Torley.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20,
Halozyme's commercially-validated solution is used to facilitate
the delivery of injected drugs and fluids in order to reduce the
treatment burden to patients. Having touched more than 600,000
patient lives in post-marketing use in five commercialized products
across more than 100 global markets, Halozyme has licensed its
ENHANZE® technology to leading pharmaceutical and
biotechnology companies including Roche, Takeda, Pfizer, AbbVie,
Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon
Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED®, TLANDO® and
NOCDURNA® and partnered commercial products and ongoing
product development programs with several pharmaceutical companies
including Teva Pharmaceutical, Covis Pharma, Pfizer and Idorsia
Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's expected
future financial performance (including the Company's financial
outlook for 2023) and expectations for future growth,
profitability, total revenue, and royalty revenue. Forward-looking
statements regarding the Company's business may include
potential growth and receipt of royalty payments driven by our
partners' development and commercialization efforts and the
potential impact of the decision on a co-formulation patent
referenced in this press release on the Company's 2023 financial
guidance, ability of our licensees to obtain co-formulation patents
and on certain composition of matter patents and the impact of
appealing the decision. These forward-looking statements are
typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected levels of revenues,
expenditures and costs, unexpected impact of the co-formulation
patent decision referenced in this press release including
unexpected results or delays in our licensees' ability to obtain
co-formulation patents or in appealing the decision, the growth of
the Company's business, or in the development, regulatory review or
commercialization of the Company's partnered or proprietary
products, regulatory approval requirements, unexpected adverse
events or patient outcomes and competitive conditions. These and
other factors that may result in differences are discussed in
greater detail in the Company's most recently filed Annual Report
on Form 10-K filed with the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@antarespharma.com
Dawn Schottlandt / Claudia Styslinger
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Media:
David Rosen
Argot Partners
david.rosen@argotpartners.com
212-600-1902
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SOURCE Halozyme Therapeutics, Inc.