Company Projects No Impact on U.S. or European
Royalty Revenues from DARZALEX FASPRO® and SC through
2032
Reiterates 2024 Royalty Revenue Guidance of
$520-555 million and Expectations to
Generate >$1 billion in
2027
Conference Call Scheduled Today, Thursday, October 24 at 5:30am PT/8:30am
ET
SAN
DIEGO, Oct. 24, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today provided an update
following a decision by the Opposition Division of the European
Patent Office ("EPO") to revoke one of the Janssen Biotech, Inc.
(Janssen) co-formulation patents for DARZALEX®
(daratumumab) SC (Patent EP 3827845).
"We remain confident in our strong royalty revenue projections
with 8 approved partner products on the market today, which is
expected to reach 10 by 2025. The EPO decision on a single
co-formulation patent in Europe
has no impact on our 2024 royalty revenue projections and
expectations to exceed $1 billion in
royalty revenues in 2027. We also project no impact on our U.S. or
European royalty revenues on sales of DARZALEX FASPRO and SC
through 2032. Additionally, this decision has no impact on
the ability of any other Halozyme licensee to obtain co-formulation
patents for their innovations," said Dr. Helen Torley, president and chief executive
officer.
"While we are disappointed with the EPO's decision today, if
Janssen files an appeal in the case, today's decision would be
suspended and the patent would remain in force until the case is
finally decided," Dr. Torley concluded.
Today's decision by the EPO has no impact on Halozyme's
composition of matter patents in the U.S. and Europe for ENHANZE®.
Halozyme will provide additional details on today's EPO decision
and its intellectual property portfolio during an Investor Update
conference call today, Thursday, October
24 at 5:30am PT/8:30am ET. A webcast of the live call and
presentation will be available through the "Investors" section of
Halozyme's corporate website at ir.halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive
solutions to improve patient experiences and outcomes for emerging
and established therapies. As the innovators of ENHANZE® drug
delivery technology with the proprietary enzyme rHuPH20, Halozyme's
commercially-validated solution is used to facilitate the
subcutaneous delivery of injected drugs and fluids, with the goal
of improving the patient experience with rapid subcutaneous
delivery and reduced treatment burden. Having touched more than
800,000 patient lives in post-marketing use in eight commercialized
products across more than 100 global markets, Halozyme has licensed
its ENHANZE® technology to leading pharmaceutical and biotechnology
companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli
Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai
Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technologies that are designed to provide
commercial or functional advantages such as improved convenience,
reliability and tolerability, and enhanced patient comfort and
adherence. The Company has two commercial proprietary products,
Hylenex® and XYOSTED®, partnered commercial products and ongoing
product development programs with several pharmaceutical companies
including Teva Pharmaceuticals 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 royalty
revenue projections for 2024, 2027 and through 2032).
Forward-looking statements regarding the Company's business may
include statements about the expected number of future approved
partnered products, 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 2024 royalty revenue guidance and future royalty revenues
through 2032, and the 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 "expect," "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,
unexpected impacts on our composition of matter patents, unexpected
results regarding the growth of the Company's business or number of
future approved partnered products, 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 and Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission. Except as
required by law, the Company undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
