Company Granted New European Patent for
ENHANZE® Drug Delivery Platform
SAN
DIEGO, June 6, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
the Company is raising its full year 2024 financial guidance and
updating its 5-year financial outlook based on the grant of
European Patent No. 4269578, covering the ENHANZE®
rHuPH20 product obtained from Halozyme's ENHANZE®
manufacturing methods that the Company provides to its current and
future licensees. The new patent is licensed under all of
Halozyme's ENHANZE® licenses. It will be validated in 37
European countries and expires on March 6,
2029.
"We are pleased to be able to raise our full year 2024 financial
guidance and 5-year financial outlook, which now reflect the
original royalty rate for DARZALEX SC in Europe from the granting of this new European
patent, which is valid through March 6,
2029," said Dr. Helen Torley,
president and chief executive officer of Halozyme.
Under the terms of Halozyme's ENHANZE® license with
Janssen, the newly granted patent prevents the reduction in the
royalty rate on sales of DARZALEX® SC in the European
countries where it is validated until the patent expires. The new
patent is not expected to have any impact to royalties under other
ENHANZE® licenses with an issued or pending
collaboration patent, as current royalty rates for these licenses
already are expected to extend beyond expiration of the new
patent.
Based on the new European patent for ENHANZE®, the
Company is raising its full year 2024 financial guidance and
updating its 5-year financial outlook during its investor
presentation.
For the full year 2024, the Company expects:
- Total revenue of $935 million to
$1,015 million, representing growth
of 13% to 22% over 2023, primarily driven by increases in royalty
revenue, collaboration revenue and growth in product sales from
XYOSTED®.
- Revenue from royalties of $520
million to $555 million,
representing growth of 16% to 24% over 2023.
- Adjusted EBITDA of $555 million
to $615 million, representing growth
of 30% to 44% over 2023.
- Non-GAAP diluted earnings per share of $3.65 to $4.05,
representing growth of 32% to 46% over 2023. The Company's earnings
per share guidance does not consider the impact of potential future
share repurchases.
2024 Financial Guidance
|
|
Updated Guidance
Range
|
|
Previous Guidance
Range
|
Total
Revenue
|
|
$935 to $1,015
million
|
|
$915 to $985
million
|
Royalty
Revenue
|
|
$520 to $555
million
|
|
$500 to $525
million
|
Adjusted
EBITDA
|
|
$555 to $615
million
|
|
$535 to $585
million
|
Non-GAAP Diluted
EPS
|
|
$3.65 to
$4.05
|
|
$3.55 to
$3.90
|
Halozyme will provide additional details on the new European
patent and its 5-year financial outlook on a conference call on
Thursday, June 6 at 5:30am PT/8:30am
ET. The call and presentation are available through the
"Investors" section of Halozyme's corporate website. To access the
webcast and presentation, please visit 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 reducing treatment burden for patients. Having touched more
than 800,000 patient lives in post-marketing use in seven
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.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in
accordance with U.S. generally accepted accounting principles
("GAAP"), this press release and the accompanying tables contain
certain non-GAAP financial measures. The Company reports earnings
before interest, taxes, depreciation, and amortization ("EBITDA"),
adjusted EBITDA and Non-GAAP diluted earnings per share, and
guidance with respect to those measures, in addition to, and not as
a substitute for, or superior to, financial measures calculated in
accordance with GAAP. The Company calculates non-GAAP diluted
earnings per share excluding share-based compensation expense,
amortization of debt discount, intangible asset amortization,
transaction costs for business combinations, realized gains or
losses on marketable security sales and certain adjustments to
income tax expense. The Company calculates EBITDA excluding
interest, taxes, depreciation and amortization. The Company
calculates adjusted EBITDA excluding transaction costs for business
combinations. Reconciliations between GAAP and Non-GAAP financial
measures are included at the end of this press release. The Company
does not provide reconciliations of forward-looking adjusted
measures to GAAP due to the inherent difficulty in forecasting and
quantifying certain amounts that are necessary for such
reconciliation, including adjustments that could be made for
changes in contingent liabilities, share-based compensation expense
and the effects of any discrete income tax items. The Company
evaluates other items of income and expense on an individual basis
for potential inclusion in the calculation of Non-GAAP financial
measures and considers both the quantitative and qualitative
aspects of the item, including (i) its size and nature, (ii)
whether or not it relates to the Company's ongoing business
operations and (iii) whether or not the Company expects it to occur
as part of the Company's normal business on a regular basis.
Non-GAAP financial measures do not have any standardized meaning
and are therefore unlikely to be comparable to similarly titled
measures presented by other companies. These non-GAAP financial
measures are not meant to be considered in isolation and should be
read in conjunction with the Company's consolidated financial
statements prepared in accordance with GAAP; and are not prepared
under any comprehensive set of accounting rules or principles. In
addition, from time to time in the future there may be other items
that the Company may exclude for purposes of its non-GAAP financial
measures; and the Company may in the future cease to exclude items
that it has historically excluded for purposes of its non-GAAP
financial measures. The Company considers these non-GAAP financial
measures to be important because they provide useful measures of
the operating performance of the Company, exclusive of factors that
do not directly affect what the Company considers to be its core
operating performance, as well as unusual events. The non-GAAP
measures also allow investors and analysts to make additional
comparisons of the operating activities of the Company's core
business over time and with respect to other companies, as well as
assessing trends and future expectations. The Company uses non-GAAP
financial information in assessing what it believes is a meaningful
and comparable set of financial performance measures to evaluate
operating trends, as well as in establishing portions of our
performance-based incentive compensation programs.
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 Halozyme's financial
performance (including Halozyme's financial outlook for 2024 and
five year longer term financial outlook) and expectations for total
revenue, royalty and collaboration revenue, product sales, Adjusted
EBITDA and non-GAAP diluted earnings-per-share.
Forward-looking statements also include statements concerning the
recent grant of Halozyme's European Patent No. 4269578 covering
Halozyme's ENHANZE® drug delivery technology rHuPH20
product including the expected validation of the patent in
thirty-seven European countries, the future expected expiration
date of the patent, the expected impact the patent will have on
Halozyme's current and future ENHANZE® licenses,
including the expected prevention of the reduction in the royalty
rate Halozyme receives under the Janssen license on sales of
products co-formulated with ENHANZE® in the European
countries where the patent is validated.
These forward-looking statements are typically, but not always,
identified through use of the words "believe," "expected,"
"pending," "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 results or delays in the
validation of the recently issued European patent in European
countries and termination of the European patent prior to the
expected date of expiration. These and other factors that may
result in differences are discussed in greater detail in Halozyme's
most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission.
Except as required by law, Halozyme undertakes no duty or
obligation to update forward-looking statements to reflect events
after the date of this press 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.