2023 Total Revenue Guidance of $815 to $845
Million Representing >20% Growth Over Expected 2022
Revenue
2023 Recurring Revenues from Royalties
Projected to Grow by >20% to $445
to $455 Million
2023 EBITDA Projected to Grow by >30%
Year-Over-Year to $415 to
$440 Million
2023 Non-GAAP Diluted EPS Guidance of
$2.50 to $2.65
SAN
DIEGO, Jan. 10, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced its 2023
financial guidance and commented on its outlook for the upcoming
year.
"In 2022, we project we achieved record revenue of greater than
$655 million and we completed the
acquisition of Antares Pharma, opening up an expanded set of
opportunities for our subcutaneous drug delivery business," said
Dr. Helen Torley, president and
chief executive officer. "In 2023, we project record revenue of
$815 to $845M and greater than 30% growth in EBITDA to
$415 to $440
million. As our ENHANZE pipeline advances, we are excited
about the future royalty revenue opportunities represented in 2023
by the potential for two new commercial launches, SC efgartigimod
and SC atezolizumab."
Anticipated 2023 Key
Events:
- Projected growth of >20% in the Company's high-margin,
recurring revenue stream from royalties to approximately
$445 to $455 million driven by continued strength in
Wave 2 products, including DARZALEX® SC
(daratumumab) and Phesgo® (pertuzumab, trastuzumab
and hyaluronidase) utilizing ENHANZE® technology,
as well as full year auto-injector royalty contribution.
- Two ENHANZE® subcutaneous (SC) approvals and
commercial launches by collaboration partners, including SC
efgartigimod and SC atezolizumab.
- Four Phase 3 study data readouts from products utilizing
ENHANZE® by the Company's collaboration partners
-
- SC efgartigimod in CIDP, ITP and Pemphigus (autoimmune
disorders of the nervous system, blood and skin)
- SC ocrelizumab for certain patients with multiple
sclerosis
- At least 2 new products utilizing ENHANZE® entering
Phase 1 development by the Company's collaboration partners.
- At least one new collaboration and licensing agreement for
ENHANZE®, for a partner to test our developmental large
volume auto-injector plus ENHANZE®, and for our small
volume auto-injector.
- Initiation of a clinical study to continue to evaluate the
feasibility testing of our large volume auto-injector.
- Up to $150 million in share
repurchases, dependent on market conditions and other factors, as
part of the $750 million three-year
share repurchase plan authorized by Halozyme's board of directors
in December 2021 demonstrating the
Company's continued commitment to a balanced capital allocation
strategy.
2023 Financial Guidance:
- Revenue: Halozyme expects total revenue of $815 million to $845
million, representing growth of >20% over 2022 expected
total revenue. The Company expects revenue from royalties to
increase >20% over expected revenue from royalties in 2022, to a
range of $445 million to $455 million.
- EBITDA: Halozyme expects EBITDA of $415 million to $440
million, representing growth of >30% over 2022 expected
EBITDA and excludes the impact of amortization costs in 2023
related to the Antares Pharma acquisition.
- Earnings per Share: Halozyme expects Non-GAAP diluted
earnings per share of $2.50 to
$2.65. The Company's earnings
per share guidance does not consider the impact of potential future
share repurchases.
Table 1. 2023 Financial
Guidance
|
Guidance
Range
|
Total
Revenue
|
$815 to $845
million
|
Royalty
Revenue
|
$445 to $455
million
|
EBITDA
|
$415 to $440
million
|
Non-GAAP Diluted
EPS
|
$2.50 to
$2.65
|
About Halozyme Therapeutics,
Inc.
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.
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) 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, debt extinguishment expense, intangible asset
amortization, changes in contingent liabilities, transaction costs
for business combinations and certain adjustments to income tax
expense. 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 Halozyme'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. Halozyme 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 the Company's expected
future financial performance (including the Company's financial
outlook for 2022 and 2023) and expectations for future growth,
profitability, total revenue and royalty revenue, net income,
EBITDA and earnings-per-share and to repurchase shares under its
share repurchase program and expand the Company's platform through
potential acquisitions. Forward-looking statements regarding the
Company's ENHANZE® drug delivery technology may include
the possible benefits and attributes of ENHANZE®, its
potential application to aid in the dispersion and absorption of
other injected therapeutic drugs and facilitating more rapid
delivery and administration of larger volumes of injectable
medications through subcutaneous delivery and the Company's plans
to develop a large volume auto-injector. Forward-looking statements
regarding the Company's business may include potential growth and
receipt of royalty and milestone payments driven by our partners'
development and commercialization efforts, potential new clinical
trial study starts and readouts, regulatory submissions and product
launches, the size and growth prospects of our partners' drug
franchises, potential new collaborations and collaborative targets,
potential partnership to test our planned large volume
auto-injector and regulatory review and potential approvals of new
partnered or proprietary products. 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 delays in the execution of the
Company's share repurchase program or planned platform
expansion, unexpected results or delays in the growth of the
Company's business including any delays in entering into new
collaboration agreements, or in the development, regulatory review
or commercialization of the Company's partnered or proprietary
products, unexpected delays in the Company's plans to develop a
large volume auto-injector, including any potential delays caused
by the current COVID-19 global pandemic, 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.
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
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SOURCE Halozyme Therapeutics, Inc.