Record preliminary product revenue reported along with expected
strong 2018 growth
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced unaudited preliminary
product revenue for the fourth quarter and full year 2017 and provided
2018 product revenue guidance.
Cerus’ unaudited preliminary product revenue for the fourth quarter of
2017 was $16.2 million, an increase of 60% compared to fourth quarter of
2016. Driving the growth was an increase in global demand for INTERCEPT
platelet kits of more than 100%. Preliminary results in the quarter
reflect the initial rollout for broad use of the INTERCEPT Blood Systems
for platelets in France. Based on the fourth quarter unaudited
preliminary product revenue, the Company expects full year 2017 product
revenue to be $43.6 million, representing an increase of 17% compared to
prior year product revenue. The preliminary product revenue results
reported have not been audited and are subject to change.
“Preliminary fourth quarter sales results exceeded our expectations and
would mark the highest quarterly product revenue ever reported by Cerus.
We finished 2017 on a solid note and look forward to building on this
success throughout 2018,” said William ‘Obi’ Greenman, Cerus’ president
and chief executive officer.
“As we enter 2018, we are excited to expand patient access to INTERCEPT
across the EMEA markets, to continue to drive U.S. product adoption, and
to expand our INTERCEPT commercial portfolio with the anticipated CE
Mark submission for red cells and the progress on our planned
cryoprecipitate PMA supplement submission. We anticipate 2018 product
revenue to be in the range of $51 million to $53 million, representing
17 to 22% growth,” continued Greenman.
Cerus will provide complete fourth quarter and full year 2017 financial
results and host a call in early March.
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
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’
expected product revenue for the fourth quarter and year ended December
31, 2017; Cerus’ expectation of expanding patient access to INTERCEPT
across the EMEA markets and continuing to drive U.S. product adoption;
Cerus‘ planned INTERCEPT red blood cell CE Mark submission; anticipated
progress with Cerus’ planned cryoprecipitate PMA supplement submission;
Cerus’ anticipated 2018 annual product revenue; 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 related to preliminary financial
results, including the risks (a) that the preliminary financial results
reported in this press release only reflect information available to
Cerus at this time and may differ from actual results, (b) that the
preliminary financial results reported in this press release have not
been reviewed or audited by Cerus’ independent registered public
accounting firm, which independent registered public accounting firm has
not expressed any opinion or any other form of assurance with respect to
such preliminary financial results, and (c) that there can be no
assurance that Cerus’ actual financial results for the periods presented
in this press release will not differ from the preliminary financial
results presented in this press release and such differences could be
material; 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 annual revenue
guidance for 2018, (b) grow sales in its EMEA and other major
international markets, and/or (c) realize meaningful 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; 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 commercialize the INTERCEPT Blood System
in the United States without infringing on the intellectual property
rights of others; 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,
which will require additional regulatory approvals, (c) related to
unanticipated difficulties in meeting the planned cryoprecipitate PMA
supplement requirements, including the risk that the FDA could require
additional clinical data to support potential approval, (d) that Cerus’
blood center customers may be unable to obtain approvals by the FDA of
BLAs they have submitted to the FDA allowing for interstate transport of
blood components processed using the INTERCEPT Blood System in a timely
manner or at all, which could significantly delay or preclude Cerus’
ability to successfully commercialize the INTERCEPT Blood System to
those customers for the portion of their business involved in interstate
commerce, and (e) that Cerus may be unable to file for CE Mark approval
of the red blood cell system in Europe in the anticipated timeframe or
at all, and even if filed, 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; 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 sells 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; 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 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, 2017, filed with
the SEC on November 3, 2017. In addition, the preliminary financial
results reported in this press release should not be viewed as a
substitute for full financial statements prepared in accordance with
GAAP and are not necessarily indicative of the results to be achieved
for any future periods. Cerus disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this press
release.
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Source: Cerus Corporation