Company also provides 2021 product revenue
guidance
Cerus Corporation (Nasdaq: CERS) announced today preliminary
product revenue for the fourth quarter and full year 2020 and
provided 2021 product revenue guidance.
Cerus’ unaudited preliminary product revenue for the fourth
quarter of 2020 totaled $28.2 million, an increase of 35% over the
$20.9 million recognized during the same period in the prior year.
Based on its fourth quarter unaudited preliminary product revenue,
the Company expects full year 2020 product revenue of $91.9
million, exceeding the Company’s current 2020 product guidance
range of $89 million to $91 million. The preliminary product
revenue results have not been audited and are subject to
change.
Preliminary fourth quarter product revenue would represent the
highest quarterly product revenue ever reported by Cerus.
“Despite the challenges that our blood center customers,
hospitals and we have faced with the COVID-19 pandemic, demand for
INTERCEPT continues to grow impressively. While we anticipate that
COVID-19 may still impact our access to blood centers and hospitals
in the U.S. and western Europe in 2021, we nonetheless expect to
see continued growth in INTERCEPT platelet kit demand, particularly
in the U.S. as the new October 1 deadline for compliance with the
FDA guidance on bacterial safety approaches,” said William ‘Obi’
Greenman, Cerus’ president and chief executive officer.
“2021 will also mark our first sales of a biologic therapeutic
product – Pathogen Reduced Cryoprecipitated Fibrinogen Complex. Our
initial, limited launch will be a building phase ahead of a much
broader, nationally focused rollout we expect in 2022. Based on our
interactions and work to date, we are encouraged by the clinician
reception to the new product and look forward to introducing the
first manufactured products to hospitals for transfusion to
patients this year,” continued Greenman.
Despite ongoing pandemic-related customer access limitations,
the Company expects full year 2021 product revenue will be in the
range of $106 million to $110 million, representing growth of
approximately 15% to 20% compared to preliminary unaudited 2020
full year results. This growth is expected to be driven by strong
platelet kit demand in the U.S., as well as expected continued
market adoption in targeted international markets.
Cerus will provide complete fourth quarter and full year 2020
financial results and host a call to discuss both 2020 results and
2021 expectations in late February.
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 production of Pathogen
Reduced Cryoprecipitated 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’ 2021 annual product revenue guidance; Cerus’
expectations for continued growth in INTERCEPT platelet kit demand
in the U.S.; the anticipated limited launch and first sales of
pathogen reduced cryoprecipitated fibrinogen complex and the
subsequent nationally focused rollout, and the anticipated timing
thereof; 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 2021 annual
product revenue guidance, (b) effectively 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, and/or (e) realize any revenue contribution from its
pipeline product candidates, whether due to Cerus’ inability to
obtain regulatory approval of its pipeline product candidates, or
otherwise; risks associated with the ultimate duration and severity
of 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
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 Fresenius Kabi’s efforts
to assure an uninterrupted supply of platelet additive solution
(PAS); risks related to how any future 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 pathogen
reduced cryoprecipitated fibrinogen complex 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, and (b) manufacturing site
Biologics License Applications necessary for Cerus to begin
distributing the INTERCEPT Blood System for Cryoprecipitation may
not be obtained in a timely manner or at all; risks associated with
Cerus’ lack of experience in marketing products directly to
hospitals and expertise complying with regulations governing
finished biologics; risks associated with the uncertain nature of
BARDA’s funding over which Cerus has no control as well as actions
of Congress and governmental agencies that may adversely affect the
availability of funding under Cerus’ BARDA agreement and/or BARDA’s
exercise of any potential subsequent option periods, including in
connection with the general economic environment and uncertainty
associated with the evolving effects of the COVID-19 pandemic, such
that the anticipated activities that Cerus expects to conduct with
the funds available from BARDA may be further delayed or halted and
that Cerus may not otherwise realize the total potential value
under its agreement with BARDA; 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 the
evolving effects of the COVID-19 pandemic 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 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 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, as well as other risks
detailed in Cerus’ filings with the Securities and Exchange
Commission, including under the heading “Risk Factors” in Exhibit
99.1 to Cerus’ Current Report on Form 8-K, filed with the SEC on
December 11, 2020. In addition, to the extent that the COVID-19
pandemic adversely affects Cerus’ business and financial results,
it may also have the effect of heightening many of the other risks
and uncertainties described above. 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, 2020. Cerus is
currently in the process of finalizing its full financial results
for the quarter and year ended December 31, 2020, and the
preliminary product revenue results presented in this press release
are based only upon preliminary information available to Cerus as
of January 11, 2021. 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, 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20210111005419/en/
Jessica Hanover – VP, Corporate Affairs Cerus Corporation
925-288-6137
Cerus (NASDAQ:CERS)
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