Cerus Corporation Announces Preliminary Product Revenue Results for Fourth Quarter and Full Year 2017
January 08 2018 - 8:30AM
Business Wire
Record preliminary product revenue reported
along with expected strong 2018 growth
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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Cerus CorporationTim Lee, 925-288-6137Investor Relations
Director
Cerus (NASDAQ:CERS)
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