Preliminary Fourth Quarter and Full-Year 2023
Product Revenues of $46.8 million and $156.4 million,
respectively
2024 Product Revenues expected to be between
$172-$175 million, reflecting 10%-12% growth year over year
Cerus Corporation (Nasdaq: CERS) today announced preliminary
product revenue for the fourth quarter and full-year 2023 and
provided product revenue guidance for full-year 2024.
Cerus’ unaudited preliminary product revenue for the fourth
quarter of 2023 totaled $46.8 million, representing an increase of
6% over the $44.0 million recognized during the fourth quarter of
2022 and 18% sequentially. The Company expects its unaudited
preliminary full-year 2023 product revenue to be $156.4 million, in
line with the Company’s 2023 product revenue guidance range of
$155-$158 million. These preliminary product revenue results have
not been audited and are subject to change.
“We are pleased with the return to meaningful growth, evidenced
by our strong performance in the fourth quarter of 2023. We also
anticipate double-digit product revenue growth for full-year 2024,
driven by continued growth in the INTERCEPT Platelet franchises in
both the U.S. and internationally as well as in the INTERCEPT
Fibrinogen Complex business,” stated William “Obi” Greenman, Cerus’
president and chief executive officer.
The Company expects full-year 2024 product revenue will be in
the range of $172-$175 million. Percentage growth for the first
quarter of 2024 is expected to be in the high teens to low 20’s
range, given the seasonality of the business as well as the unusual
Q1 2023 results.
“Additionally, we continue to expect to realize adjusted EBITDA
breakeven for the fourth quarter 2023 when we report complete
fourth quarter 2023 and year-end results,” continued Greenman.
“This milestone will be important in the Company’s pursuit to fund
its future growth, and we expect its durability for 2024.”
“Beyond our commercial progress, we anticipate that 2024 will be
a meaningful year for our INTERCEPT Red Blood Cell (RBC) program.
We remain on track to provide the top-line readout from ReCePI, the
first of our two U.S. phase 3 trials for INTERCEPT RBCs, in the
first quarter of 2024, and we expect an approval decision for CE
Mark for INTERCEPT RBCs in the second half of 2024. These will be
key catalysts for advancing this program towards
commercialization,” added Greenman.
Cerus will provide complete fourth quarter and full-year 2023
financial results and host a call to discuss both 2023 results and
2024 expectations by mid-March.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Headquartered in Concord, California, the company
develops and supplies vital technologies and pathogen-protected
blood components to blood centers, hospitals, and ultimately
patients who rely on safe blood. The INTERCEPT Blood System for
platelets and plasma is available globally and remains the only
pathogen reduction system with both CE mark and FDA approval for
these two blood components. The INTERCEPT red blood cell system is
under regulatory review in Europe, and in late-stage clinical
development in the US. Also in the US, the INTERCEPT Blood System
for Cryoprecipitation is approved for the production of Pathogen
Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to
as INTERCEPT Fibrinogen Complex), a therapeutic product for the
treatment and control of bleeding, including massive hemorrhage,
associated with fibrinogen deficiency. For more information about
Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Forward Looking Statements and Preliminary Product Revenue
Results
Except for the historical statements contained herein, this
press release contains forward-looking statements concerning Cerus’
products, prospects and expected results, including statements
relating to: Cerus’ preliminary fourth quarter and full-year 2023
product revenues; Cerus’ 2024 annual product revenue guidance and
related anticipated growth percentage rate; Cerus’ expectations
regarding anticipated continued growth in the INTERCEPT Platelet
franchise in the U.S. and internationally as well as for IFC; Cerus
expecting to post non-GAAP adjusted EBITDA breakeven for the fourth
quarter of 2023 and the expected durability thereof for 2024;
Cerus’ pursuit to fund its future growth; Cerus’ expectations for
its INTERCEPT Red Blood Cell (RBC) program, including with respect
to providing the top-line readout from ReCePI in the first quarter
of 2024, Cerus’ expectation of an approval decision for CE Mark for
INTERCEPT RBCs in the second half of 2024, and the potential
commercialization of INTERCEPT RBCs; and other statements that are
not historical fact. Actual results could differ materially from
these forward-looking statements as a result of certain factors,
including, without limitation: risks associated with the
commercialization and market acceptance of, and customer demand
for, the INTERCEPT Blood System, including the risks that Cerus may
not (a) meet its 2024 annual product revenue guidance, (b)
effectively continue to launch and commercialize the INTERCEPT
Blood System for Cryoprecipitation, (c) grow sales globally,
including in its U.S. and European markets, and/or realize expected
revenue contribution resulting from its U.S. and European market
agreements, (d) realize meaningful and/or increasing revenue
contributions from U.S. customers in the near term or at all,
particularly since Cerus cannot guarantee the volume or timing of
commercial purchases, if any, that its U.S. customers may make
under Cerus’ commercial agreements with these customers, (e)
effectively expand its commercialization activities into additional
geographies and/or (f) realize any revenue contribution from its
pipeline product candidates, whether due to Cerus’ inability to
obtain regulatory approval of its pipeline programs, or otherwise;
risks associated with macroeconomic developments, including ongoing
military conflicts in Ukraine and Israel and the COVID-19 pandemic
and resulting global economic and financial disruptions, and the
current and potential future negative impacts to Cerus’ business
operations and financial results such as the current and potential
additional disruptions to the U.S. and EMEA blood supply resulting
from the evolving effects of the COVID-19 pandemic; risks
associated with Cerus’ lack of longer-term commercialization
experience with the INTERCEPT Blood System for Cryoprecipitation
and in the United States generally, and its ability to develop and
maintain an effective and qualified U.S.-based commercial
organization, as well as the resulting uncertainty of its ability
to achieve market acceptance of and otherwise successfully
commercialize the INTERCEPT Blood System in the United States,
including as a result of licensure requirements that must be
satisfied by U.S. customers prior to their engaging in interstate
transport of blood components processed using the INTERCEPT Blood
System; risks related to the highly concentrated market for the
INTERCEPT Blood System; risks related to how any future platelet
additive solution (PAS) supply disruption could affect INTERCEPT’s
acceptance in the marketplace; risks related to how any future PAS
supply disruption might affect current commercial contracts; risks
related to Cerus’ ability to demonstrate to the transfusion
medicine community and other health care constituencies that
pathogen reduction, including IFC for the treatment and control of
bleeding, and the INTERCEPT Blood System is safe, effective and
economical; risks related to the uncertain and time-consuming
development and regulatory process, including the risks that (a)
Cerus may be unable to comply with the FDA’s post-approval
requirements for the INTERCEPT Blood System, including by
successfully completing required post-approval studies, which could
result in a loss of U.S. marketing approval(s) for the INTERCEPT
Blood System, (b) additional manufacturing site Biologics License
Applications necessary for Cerus to more broadly distribute the
INTERCEPT Blood System for Cryoprecipitation may not be obtained in
a timely manner or at all, (c) Cerus may be unable to report data
from its ReCePI study in a timely manner or at all, (d) Cerus may
be unable to obtain CE Mark approval, or any other regulatory
approvals, of the INTERCEPT RBC system in a timely manner or at
all, and (e) Cerus may be unable to obtain the requisite regulatory
approvals to advance its pipeline programs and bring them to market
in a timely manner or at all; risks related to product safety,
including the risk that the septic platelet transfusions may not be
avoidable with the INTERCEPT Blood System; risks related to adverse
market and economic conditions, including continued or more severe
adverse fluctuations in foreign exchange rates and/or continued or
more severe weakening in economic conditions resulting from
military conflicts, the COVID-19 pandemic, rising interest rates,
inflation or otherwise in the markets where Cerus currently sells
and is anticipated to sell its products; Cerus’ reliance on third
parties to market, sell, distribute and maintain its products;
Cerus’ ability to maintain an effective, secure manufacturing
supply chain, including the risks that (a) Cerus’ supply chain
could be negatively impacted as a result of the evolving impact of
macroeconomic developments, including the ongoing military
conflicts in Ukraine and Israel, rising interest rates, inflation
and the evolving effects of the COVID-19 pandemic, (b) Cerus’
manufacturers could be unable to comply with extensive FDA and
foreign regulatory agency requirements, and (c) Cerus may be unable
to maintain its primary kit manufacturing agreement and its other
supply agreements with its third party suppliers; Cerus’ ability to
identify and obtain additional partners to manufacture the
INTERCEPT Blood System for Cryoprecipitation; risks associated with
Cerus’ ability to access additional funds under its credit facility
and to meet its debt service obligations, and its need for
additional funding; the impact of legislative or regulatory
healthcare reforms that may make it more difficult and costly for
Cerus to produce, market and distribute its products; risks related
to future opportunities and plans, including the uncertainty of
Cerus’ future capital requirements and its future revenues and
other financial performance and results, including as it relates to
Cerus expecting to post non-GAAP adjusted EBITDA breakeven for the
fourth quarter of 2023 and Cerus’ pursuit to fund its future
growth, as well as other risks detailed in Cerus’ filings with the
Securities and Exchange Commission, including under the heading
“Risk Factors” in Cerus’ Quarterly Report on Form 10-Q for the
quarter ended September 30, 2023, filed with the SEC on November 2,
2023. Cerus disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press
release.
This press release includes Cerus’ preliminary product revenue
results for the quarter and year ended December 31, 2023. Cerus is
currently in the process of finalizing its full financial results
for the quarter and year ended December 31, 2023, and the
preliminary product revenue results presented in this press release
are based only upon preliminary information available to Cerus as
of January 8, 2024. Cerus’ preliminary product revenue results
should not be viewed as a substitute for full audited financial
statements prepared in accordance with U.S. GAAP, and undue
reliance should not be placed on Cerus’ preliminary product revenue
results. In addition, Cerus’ independent registered public
accounting firm has not audited or reviewed the preliminary product
revenue results included in this press release or expressed any
opinion or other form of assurance on such preliminary product
revenue results. In addition, items or events may be identified or
occur after the date hereof due to the completion of operational
and financial closing procedures, final audit adjustments and other
developments may arise that would require Cerus to make material
adjustments to the preliminary product revenue results included in
this press release. Therefore, the preliminary product revenue
results included in this press release may differ, perhaps
materially, from the product revenue results that will be reflected
in Cerus’ audited consolidated financial statements for the year
ended December 31, 2023.
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net income (loss) attributable to
Cerus Corporation as reported on the consolidated statement of
operations, as adjusted to exclude (i) net income (loss)
attributable to noncontrolling interest, (ii) provision for
(benefit from) income taxes, (iii) foreign exchange (loss)/gain,
(iv) interest expense, (v) other income (expense), net (vi)
depreciation and amortization, (vii) share-based compensation,
(viii) goodwill and asset impairments, (ix) costs associated with
our noncontrolling interest in our joint venture in China, (x)
revenue and direct costs associated with our government contracts
and (xi) restructuring charges. We are presenting this non-GAAP
financial measure to assist investors in assessing our operating
results. Management believes this non-GAAP information is useful
for investors, when considered in conjunction with Cerus’ GAAP
financial statements, because management uses such information
internally for its operating, budgeting and financial planning
purposes. Non-GAAP information is not prepared under a
comprehensive set of accounting rules and should only be used to
supplement an understanding of Cerus’ operating results as reported
under GAAP. This non-GAAP financial measure should not be
considered in isolation from, or as a substitute for, financial
information prepared in accordance with GAAP. This non-GAAP
financial measure is not necessarily comparable to similarly-titled
measures presented by other companies. Cerus has not provided a
reconciliation of its anticipated non-GAAP adjusted EBITDA
breakeven in the fourth quarter of 2023 to estimated fourth quarter
2023 GAAP net loss attributable to Cerus Corporation because many
items that are components of GAAP net loss attributable to Cerus
Corporation cannot be reasonably estimated at this time pending
completion of Cerus Corporation’s ongoing year-end financial
closing procedures. These components of GAAP net loss attributable
to Cerus Corporation could significantly impact the reported GAAP
net loss attributable to Cerus Corporation.
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Jessica Hanover – Vice President, Corporate Affairs Cerus
Corporation 925-288-6137
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