2019 product revenue guidance of $70 million to $73 million,
representing growth of 15% to 20% over preliminary 2018 results
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) today announced unaudited preliminary
product revenue for the fourth quarter and full year 2018 and provided
2019 product revenue guidance.
Cerus’ unaudited preliminary product revenue for the fourth quarter of
2018 totaled $16.5 million compared to $16.2 million during the same
period the prior year. Based on the fourth quarter unaudited preliminary
product revenue, the Company expects full year 2018 product revenue to
be $60.9 million, ahead of the top end of the range of the Company’s
most recent guidance of $58 million to $60 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 the Company. Cerus expects
2019 product revenue to be in the range of $70 million to $73 million,
representing 15% to 20% growth compared to the preliminary 2018 results.
“The revenue growth we generated in 2018 underscores the increasing
demand for safer blood components. We finished 2018 strong with
quarter-over-quarter and year-to-date growth in disposable kits led by
French national conversion and U.S. demand,” said William ‘Obi’
Greenman, Cerus’ president and chief executive officer.
“Over the past few months, U.S. customer orders for INTERCEPT platelets
have been increasing. With the recent FDA publication of the draft
guidance document on bacterial risk control strategies for platelet
collection and transfusion, we could potentially experience further
acceleration in customer demand in the U.S.,” continued Greenman.
Heading into 2019, the Company will continue to advance its mission to
make INTERCEPT the standard of care for transfused blood components
globally and to enable its customers to deliver safe and effective blood
products to patients. In addition to delivering on the stated revenue
growth goals, other anticipated 2019 milestones include the planned U.S.
regulatory submission on pathogen-reduced cryoprecipitate, additional
cryoprecipitate manufacturing partnerships, and progress on the U.S.
INTERCEPT red blood cell clinical studies.
Cerus will provide complete fourth quarter and full year 2018 financial
results and host a call to discuss both 2018 results and 2019
expectations in late February.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections by inactivating a
broad range of pathogens such as viruses, bacteria and parasites that
may be present in donated blood. The nucleic acid targeting mechanism of
action of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as hepatitis B and C, HIV, West Nile virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. Cerus currently markets and sells the INTERCEPT Blood System for
both platelets and plasma in the United States, Europe, the Commonwealth
of Independent States, the Middle East and selected countries in other
regions around the world. The INTERCEPT Red Blood Cell system is in
clinical development. See http://www.cerus.com
for information about Cerus.
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’
2019 annual product revenue guidance; the potential for further
acceleration in customer demand in the U.S.; Cerus’ mission to make
INTERCEPT the standard of care for transfused blood components globally
and to enable its customers to deliver safe and effective blood products
to patients; Cerus’ anticipated 2019 milestones, including the planned
U.S. regulatory submission on pathogen-reduced cryoprecipitate,
additional cryoprecipitate manufacturing partnerships, and ongoing
advancement of its U.S. red blood cell clinical program; 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 2019 annual product revenue guidance, (b) grow sales in its U.S. and
European markets and/or realize expected revenue contribution resulting
from its U.S. and European market agreements, and/or (c) 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 (d) 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 Cerus’ lack of commercialization experience in the
United States 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 for platelets and
plasma 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 and the INTERCEPT Blood System is safe, effective and
economical; the uncertain and time-consuming development and regulatory
process, including the risks (a) that Cerus may be unable to comply with
the FDA’s post-approval requirements for the INTERCEPT platelet and
plasma systems, including by successfully completing required
post-approval studies, which could result in a loss of U.S. marketing
approval for the INTERCEPT platelet and/or plasma systems, (b) related
to Cerus’ ability to expand the label claims and product configurations
for the INTERCEPT platelet and plasma systems in the United States,
including for INTERCEPT-treated extended storage cryoprecipitate from
plasma, which will require additional regulatory approvals, (c) that
Cerus may be unable to obtain CE Mark approval, or any other regulatory
approvals, of the red blood cell system in a timely manner or at all,
(d) that Cerus may be unable to submit its planned PMA supplement to the
FDA for INTERCEPT-treated extended storage cryoprecipitate from plasma
on the anticipated timeframe or at all, and even if submitted, Cerus may
be unable to obtain FDA approval, or any other regulatory approvals, of
INTERCEPT-treated extended storage cryoprecipitate from plasma in a
timely manner or at all, (e) that applicable regulatory authorities may
disagree with Cerus‘ interpretations of the data from its clinical
studies and/or may otherwise determine not to approve Cerus’ regulatory
submissions in a timely manner or at all, (f) that Cerus may be unable
to obtain FDA clearance to initiate a potential additional Phase 3
clinical trial of the red blood cell system and may otherwise be unable
to advance the development of the red blood cell system in the U.S. in a
timely manner or at all, and (g) that anticipated clinical trials of the
INTERCEPT Blood System may not be initiated on the anticipated timing or
at all, or if initiated, may be extended, delayed, suspended or
terminated, including as result of safety concerns; 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 which
may adversely affect the availability of funding under Cerus’ BARDA
agreement and/or BARDA’s exercise of any potential subsequent option
periods, such that the anticipated activities that Cerus expects to
conduct with the funds available from BARDA may be 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 weakening economic conditions 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
manufacturing supply chain, including the ability of its manufacturers
to comply with extensive FDA and foreign regulatory agency requirements,
Cerus’ ability to maintain its primary kit manufacturing agreement and
its other supply agreements with its third party suppliers, and Cerus’
ability to identify and obtain additional partners to manufacture
extended-storage cryoprecipitate; 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
Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30,
2018, filed with the SEC on November 1, 2018. 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, 2018. Cerus is currently in
the process of finalizing its full financial results for the quarter and
year ended December 31, 2018, and the preliminary product revenue
results presented in this press release are based only upon preliminary
information available to Cerus as of January 7, 2019. 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, 2018.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20190107005303/en/
Tim Lee – Investor Relations Director
Cerus Corporation
925-288-6137
Source: Cerus Corporation