CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq:CERS) announced today financial results for
the first quarter ended March 31, 2018, and raised its full year
guidance for product revenue.
First Quarter Highlights and Recent Events
-
First quarter product revenue of $13.6 million
-
Year-over-year Q1 worldwide disposable kit volume up over 100%
-
Raising full year product revenue guidance range to $53 million to $55
million from $51 million to $53 million
-
Cash and cash equivalents balance of $105.9 million at March 31, 2018
-
Received Canadian regulatory approval for INTERCEPT Blood Systems for
platelets
-
Expanded enrollment sites for the phase 3 RedeS clinical trial of
INTERCEPT-treated red blood cells into Texas and Florida
“The commercial momentum we experienced exiting 2017 continued into 2018
with first quarter product revenue of $13.6 million, exceeding our
expectations. Global demand for platelet kits continued to be robust
with first quarter platelet kit sales volumes more than doubling
compared to the prior year, led by increased shipments in France and in
the U.S.,” said William ‘Obi’ Greenman, Cerus’ president and chief
executive officer. “Given the strong first quarter results and the
current visibility into our commercial pipeline, we are raising our full
year product revenue guidance range to $53 million to $55 million
compared to our previous range of $51 million to $53 million.”
“We continue to push forward with our mission to establish INTERCEPT as
the global standard of care for transfused blood components,” continued
Greenman. “In the U.S., blood centers are continuing to increase
production of INTERCEPT platelets to meet the ever growing hospital
demand for pathogen-reduced platelets. In France, we gained additional
regulatory approvals on our dual storage processing set for INTERCEPT
platelets and shelf-life extension from five to seven days which should
allow for increased blood center operational efficiencies and lower
product wastage.”
During the quarter, the Company’s development programs continued to
progress with the Ultra-Performance Liquid Chromatography (UPLC) lot
release assay achieving validation to support its anticipated CE Mark
submission for INTERCEPT red cells, and the INTERCEPT cryoprecipitate
program advancing the required stability studies for its planned
premarket approval (PMA) supplement submission to the U.S. Food and Drug
Administration (FDA).
Revenue
Product revenue for the first quarter of 2018 was $13.6 million,
compared to $7.0 million during the same period in 2017. The increase in
product revenue was driven by quarter-over-quarter increases in platelet
kit demand, partially offset by declines in plasma kits and illuminator
sales. Reported product revenue in the quarter also benefitted from
favorable foreign currency exchange rates.
Government contract revenue from the Company’s Biomedical Advanced
Research and Development Authority (BARDA) agreement was $3.5 million in
the first quarter of 2018 compared to $1.4 million during the same
period in 2017 as a result of increasing INTERCEPT red cell clinical and
development activities. BARDA is part of the Office of the Assistant
Secretary for Preparedness and Response within the U.S. Department of
Health and Human Services.
Gross Margins
Gross margins on product revenue for the first quarter of 2018 were 46%,
compared to 47% for the first quarter of 2017. Gross margins on product
sales remained relatively stable due to a variety of factors including
economies of scale and lower costs due to increased platelet production,
pricing for high volume customers, and foreign exchange rates.
Operating Expenses
Total operating expenses were $23.0 million for the quarter ended March
31, 2018, compared to $22.8 million for the quarter ended March 31, 2017.
Selling, general, and administrative expenses for the first quarter of
2018 remained relatively flat at $13.6 million, compared to $13.7
million for the first quarter of 2017 as the Company continued to
leverage its existing commercial and back-office infrastructure.
Research and development (R&D) expenses for the first quarter of 2018
were $9.4 million compared to $9.2 million for the first quarter of
2017. Expenses associated with the clinical development of the Company’s
INTERCEPT red blood cell program increased while non-BARDA related R&D
expenses declined as the Company re-allocated R&D personnel to the BARDA
activities.
Operating and Net Loss
Operating losses during the first quarter of 2018 were $13.4 million,
compared to $18.1 million during the first quarter of 2017.
Net loss for the first quarter of 2018 was $13.9 million, or $0.11 per
diluted share, compared to a net loss of $18.6 million, or $0.18 per
diluted share, for the first quarter of 2017.
Cash, Cash Equivalents and Investments
At March 31, 2018, the Company had cash, cash equivalents and short-term
investments of $105.9 million compared to $60.7 million at December 31,
2017.
At March 31, 2018, the Company had approximately $29.8 million in
outstanding debt under its loan agreement with Oxford Finance. The loan
agreement provides for an additional $10 million term loan (and, if
drawn, an extension of the interest only period) upon the Company
achieving pre-determined revenue levels. The Company achieved the
pre-determined revenue levels as of March 31, 2018, but has not
currently exercised its option on the additional $10 million term loan
and interest only extension. The option expires on May 14, 2018.
QUARTERLY CONFERENCE CALL
The Company will host a conference call and webcast at 4:15 p.m. Eastern
time today to discuss its financial results and provide a general
business overview and outlook. To access the live webcast, please visit
the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
Alternatively, you may access the live conference call by dialing (866)
235-9006 (U.S.) or (631) 291-4549 (international).
A replay will be available on the Company’s website, or by dialing (855)
859-2056 (U.S.) or (404) 537-3406 (international) and entering
conference ID number 2366225. The replay will be available approximately
three hours after the call through May 22, 2018.
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 concerning Cerus’
2018 annual product revenue guidance; Cerus’ mission to establish
INTERCEPT as the global standard of care for transfused blood
components; Cerus’ planned INTERCEPT red blood cell system CE Mark
submission; Cerus’ planned PMA supplement submission for
INTERCEPT-treated extended storage cryoprecipitate from plasma; Cerus’
expectation that additional French regulatory approvals on its dual
storage processing set for INTERCEPT platelets and shelf-life extension
should allow for increased blood center operational efficiencies and
lower product wastage; 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 European markets, including in
France, and/or realize expected revenue contribution resulting from its
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; 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; 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, 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’ Annual Report on Form 10-K for the year
ended December 31, 2017, filed with the SEC on March 8, 2018. Cerus
disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release.
|
|
|
|
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED
STATEMENTS OF OPERATIONS
(in thousands, except per
share information)
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2018
|
|
2017
|
Product revenue
|
|
$
|
13,564
|
|
|
$
|
7,006
|
|
Cost of product revenue
|
|
|
7,330
|
|
|
|
3,694
|
|
Gross profit on product revenue
|
|
|
6,234
|
|
|
|
3,312
|
|
Government contract revenue
|
|
|
3,455
|
|
|
|
1,428
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
|
9,437
|
|
|
|
9,150
|
|
Selling, general and administrative
|
|
|
13,607
|
|
|
|
13,683
|
|
Total operating expenses
|
|
|
23,044
|
|
|
|
22,833
|
|
Loss from operations
|
|
|
(13,355
|
)
|
|
|
(18,093
|
)
|
Non-operating expense, net
|
|
|
(476
|
)
|
|
|
(470
|
)
|
Loss before income taxes
|
|
|
(13,831
|
)
|
|
|
(18,563
|
)
|
Provision for income taxes
|
|
|
54
|
|
|
|
35
|
|
Net loss
|
|
$
|
(13,885
|
)
|
|
$
|
(18,598
|
)
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
Basic
|
|
$
|
(0.11
|
)
|
|
$
|
(0.18
|
)
|
Diluted
|
|
$
|
(0.11
|
)
|
|
$
|
(0.18
|
)
|
Weighted average shares outstanding used for calculating net loss
per share:
|
|
|
|
|
Basic
|
|
|
124,814
|
|
|
|
103,564
|
|
Diluted
|
|
|
124,814
|
|
|
|
103,564
|
|
|
|
|
|
|
|
|
|
|
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED
BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2018
|
|
2017
|
ASSETS
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
14,877
|
|
$
|
13,683
|
Short-term investments
|
|
|
90,988
|
|
|
47,013
|
Accounts receivable
|
|
|
10,489
|
|
|
12,415
|
Inventories
|
|
|
13,165
|
|
|
14,457
|
Other current assets
|
|
|
4,257
|
|
|
2,330
|
Total current assets
|
|
|
133,776
|
|
|
89,898
|
Non-current assets:
|
|
|
|
|
Property and equipment, net
|
|
|
1,969
|
|
|
2,119
|
Goodwill and intangible assets, net
|
|
|
1,802
|
|
|
1,852
|
Restricted cash and other assets
|
|
|
6,874
|
|
|
4,375
|
Total assets
|
|
$
|
144,421
|
|
$
|
98,244
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
21,588
|
|
$
|
22,686
|
Debt - current
|
|
|
1,429
|
|
|
-
|
Deferred product revenue - current
|
|
|
639
|
|
|
445
|
Total current liabilities
|
|
|
23,656
|
|
|
23,131
|
Non-current liabilities:
|
|
|
|
|
Debt - non-current
|
|
|
28,387
|
|
|
29,798
|
Manufacturing and development obligations - non-current
|
|
|
5,996
|
|
|
5,766
|
Other non-current liabilities
|
|
|
784
|
|
|
609
|
Total liabilities
|
|
|
58,823
|
|
|
59,304
|
Stockholders' equity
|
|
|
85,598
|
|
|
38,940
|
Total liabilities and stockholders' equity
|
|
$
|
144,421
|
|
$
|
98,244
|
|
|
|
|
|
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180508006408/en/
Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
Source: Cerus Corporation