CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) is presenting its strategic roadmap and
outlining its multi-year growth strategy at the 2018 Cerus Institutional
Investor Meeting today in Boston.
“Our efforts to establish the INTERCEPT Blood System as the standard of
care for transfused blood components globally continue to gain
traction,” commented William ‘Obi’ Greenman, Cerus’ president and chief
executive officer. “With the increasing visibility into our commercial
opportunities and the advances in our research and development pipeline,
we believe that we are poised to sustain meaningful product revenue
growth for the next several years.”
“Our preliminary Q3 product revenue of $15.4 million underscores the
strong market demand for the INTERCEPT Blood System during the quarter,
especially in the U.S. Given our preliminary Q3 results, we are raising
our full year product revenue guidance from a range of $56 million to
$58 million to our new range of $58 million to $60
million, representing an increase of 33% to 38% compared to 2017
product revenue,” continued Greenman.
“Growth in 2018 has been largely driven by the conversion of the French
platelet market to INTERCEPT-treated platelets and from strong growth in
the U.S.,” noted Kevin D. Green, Cerus’ vice president and chief
financial officer. “As we look ahead to 2019, we anticipate revenue
growth from continued U.S. market adoption, with or without a final FDA
guidance document on bacterial safety of platelets, and contribution
from the German market toward the latter part of 2019. In 2020 and
beyond, we anticipate revenue growth to accelerate due to the
anticipated regulatory approval and commercialization of our pipeline
product candidates, including INTERCEPT red blood cells in Europe and
extended storage pathogen-reduced cryoprecipitate.”
The agenda for today’s meeting will cover the following:
INTERCEPT Red Blood Cells: Dr. Richard Benjamin, Cerus’ chief
medical officer will provide a framework on our U.S. and European
clinical development efforts and the timelines for regulatory
submission. The Company is on track to submit its CE Mark filing by the
end of this year.
Pathogen-Reduced Cryoprecipitate: Dr. Laurence Corash, Cerus’
co-founder and chief scientific officer will outline the clinical
rationale for pathogen-reduced cryoprecipitate with a targeted post-thaw
shelf life of five days compared to four to six hours for conventional
cryoprecipitate. The Company anticipates submitting the PMA-supplement
for pathogen-reduced cryoprecipitate in the second half of 2019.
Commercial Update: Vivek K. Jayaraman, Cerus’ chief commercial
officer, will provide an update on the Company’s domestic and
international growth opportunities.
Financial Update: Kevin D. Green, Cerus vice president of finance
and chief financial officer will provide a framework on the Company’s
anticipated near to mid-term product revenue growth prospects, the
potential impact of increasing kit volumes on gross margin, and the
anticipated operating leverage from the Company’s commercial
infrastructure as the business scales.
Guest speakers at today’s meeting include:
Dr. Edward Snyder, Professor Laboratory Medicine, Yale University
Medical School, Director, Blood and Tissue Bank Services. Dr. Snyder
will discuss Yale’s experience with INTERCEPT platelets and the clinical
need for pathogen-reduced red blood cells.
Dr. Melissa Cushing, Associate Professor of Clinical Pathology and
Laboratory Medicine at Weill Cornell Medical College, Associate Director
of Clinical Laboratories and the Director of Transfusion Medicine and
Cellular Therapy at New York-Presbyterian Hospital, Weill Cornell
Campus. Dr. Cushing will discuss the critical role of rapid
cryoprecipitate transfusion in treating coagulopathy in bleeding
patients.
Dr. Susan Stramer, Vice President, Scientific Affairs, Biomedical
Services, American Red Cross. Dr. Stramer will discuss the American Red
Cross’ strategy and plans to more broadly roll-out pathogen-reduced
platelets.
Webcast Information
A live webcast of Cerus’ Institutional Investor Meeting will be
available today, October 16, starting at 9:30 a.m. E.T. and
can be accessed from the Investor Relations page of the Cerus web site
at http://www.cerus.com/ir.
A replay will be available for approximately two weeks following the
completion of the event.
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 concerning Cerus’
adjusted 2018 annual product revenue guidance; the potential contract
value of Cerus’ amended agreement with BARDA; the potential to avoid
septic platelet transfusions with the INTERCEPT Blood System; the
potential to expand the usage claims for the INTERCEPT Blood System;
Cerus’ planned INTERCEPT red blood cell system CE Mark submission and
the anticipated timing thereof; Cerus’ mission to establish INTERCEPT
Blood Systems as the standard of care for transfused blood components
globally; Cerus’ belief that it is poised to sustain meaningful product
revenue growth for the next several years; Cerus’ expectation for
revenue growth in 2019 and in 2020 and beyond, and the anticipated
reasons therefor; anticipated regulatory approval and commercialization
of Cerus’ pipeline product candidates, including INTERCEPT red blood
cells in Europe and extended storage pathogen-reduced cryoprecipitate,
and the anticipated timing thereof; Cerus’ planned INTERCEPT red blood
cell system CE Mark submission and planned PMA supplement for extended
storage pathogen-reduced cryoprecipitate, and the anticipated timing
thereof; Cerus’ expectations for increasing kit volumes and future
operating leverage; and other statements that are not historical facts.
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 adjusted revenue
guidance for 2018, (b) grow sales in its U.S. and European markets,
including in France, and/or realize expected revenue contribution
resulting from its U.S. and European market agreements, 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; 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 file for CE Mark approval of the red blood cell system in
Europe on 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,
(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, and (f) 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; risk 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, and Cerus’ ability to maintain
its primary kit manufacturing agreement and its other supply agreements
with its third party suppliers; 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 June 30, 2018, filed
with the SEC on August 2, 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 ended September 30, 2018. Cerus is currently in
the process of finalizing its full financial results for the quarter
ended September 30, 2018, and the preliminary product revenue results
presented in this press release is based only upon preliminary
information available to Cerus as of October 16, 2018. Cerus’
preliminary product revenue results should not be viewed as a substitute
for full interim 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 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 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 from the product revenue results that will be reflected in Cerus’
complete condensed consolidated financial statements for the three
months ended September 30, 2018.