Cerus Corporation (Nasdaq: CERS) today announced financial
results for the fourth quarter and year ended December 31,
2020.
Recent developments and highlights include:
- Record total fourth quarter and full year 2020 revenues of
$33.6 million and $114.2 million, respectively. Total revenue was
composed of (in millions, except %):
Revenue by Segment
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020
2019
Change
2020
2019
Change
Product revenue
$
28.2
$
20.9
35
%
$
91.9
$
74.6
23
%
Government contract revenue
$
5.4
$
5.6
-3
%
$
22.3
$
19.1
17
%
Total revenue
$
33.6
$
26.5
27
%
$
114.2
$
93.8
22
%
- Provided 2021 annual product revenue guidance of $106 million
to $110 million, representing an approximately 15% to 20% increase
over 2020 reported product revenue.
- Received FDA approval for the INTERCEPT Blood System for
Cryoprecipitation, which can now be used to produce two products:
Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo FC)
for the treatment and control of bleeding, including massive
hemorrhage, associated with fibrinogen deficiency, and a derivative
product, called Pathogen Reduced Plasma, Cryoprecipitate
Reduced.
- Announced the formation of a joint venture with Shandong
Zhongbaokang Medical Implements that intends to develop, register,
manufacture and commercialize the INTERCEPT Blood System for
platelets and red blood cells in China.
- Announced Brazilian distribution partner, CEI, was awarded a
three-year tender award for the INTERCEPT Blood System for
platelets with the HemoMinas Foundation of Brazil.
- Ended 2020 with cash, cash equivalents, and short-term
investments of $133.6 million at December 31, 2020.
“The COVID-19 pandemic has fundamentally altered the way the
world thinks about pandemic preparedness. As we recognize a record
quarter and year for our business, there remains much work to do
with blood centers and hospitals around the world to ensure the
safety and availability of the blood supply and protect patients
from infectious viral diseases and bacterial contaminants. During a
year unlike any other, I am proud of the significant commercial
momentum we generated in 2020 to help advance pathogen reduced
blood products towards the standard of care in transfusion
medicine,” said William ‘Obi’ Greenman, Cerus’ president and chief
executive officer. “With customers continuing to increase
production of INTERCEPT platelets, we are poised for another year
of solid top-line growth in 2021. Additionally, our team is working
to launch our recently FDA approved Pathogen Reduced Cryoprecipitated Fibrinogen
Complex product and to advance our pipeline programs. While
we have made tremendous progress, we still have much work to do to
realize our mission to safeguard the global blood supply. We look
forward to updating our stakeholders as we make progress towards
our key milestones over the course of the year.”
Revenue
Product revenue during the fourth quarter of 2020 was $28.2
million, compared to $20.9 million during the same period in 2019.
Product revenue growth in the quarter benefited from strong
continued demand for INTERCEPT platelet kits in the U.S., continued
growth in platelet kit demand in EMEA, and strong illuminator
sales. For the full year, product revenue totaled $91.9 million, an
increase of 23% compared to the same period in 2019.
Although the Company generally had more activity during 2020 for
its INTERCEPT red blood cell system covered through its contract
with the Biomedical Advanced Research and Development Authority
(BARDA), there were a number of COVID-19 related delays and
disruptions to clinical activities. Accordingly, government
contract revenue primarily from the BARDA agreement was $5.4
million during the fourth quarter of 2020, compared to $5.6 million
during the same period in 2019. Full year 2020 government contract
revenue totaled $22.3 million compared to $19.1 million in the same
period of the year prior. The total potential value of the current
BARDA agreement is $214 million, with $66.4 million cumulatively
recognized as government contract revenue through December 31,
2020.
BARDA is part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services. The development of the INTERCEPT red blood cell
program has been funded in whole or in part with Federal funds from
the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201600009C.
Gross Margins
Gross margins on product revenue during the fourth quarter of
2020 were 56.8% compared to 55.6% for the fourth quarter of 2019.
The increase in gross margin was tied to increased volumes of
INTERCEPT kits sold, driving economies of scale within our
production cycle, and favorable foreign exchange rates with a
weakening U.S. dollar relative to the Euro. Gross margins on
product revenue for the full year 2020 and 2019 were 55.2%.
Operating Expenses
Total operating expenses for the fourth quarter of 2020 were
$35.8 million compared to $33.6 million for the same period of the
prior year. Full year 2020 operating expenses totaled $131.4
million compared to $126.6 million for the full-year 2019.
Selling, general, and administrative (SG&A) expenses for the
fourth quarter of 2020 totaled $18.7 million, compared to $17.2
million for the fourth quarter of 2019. The year-over-year increase
in SG&A expenses was tied to increased non-cash stock-based
compensation, and investments ahead of the Company’s anticipated
PR-Cryo FC launch. Full-year 2020 SG&A expenses totaled $67.0
million compared to $66.2 million for the full-year 2019.
Research and development (R&D) expenses for the fourth
quarter of 2020 were $17.1 million, compared to $16.4 million for
the fourth quarter of 2019. The year-over-year increase in R&D
expenses was largely due to non-cash stock-based compensation and
product enhancements and initiatives for expanded label claims.
Full-year 2020 R&D expenses totaled $64.4 million compared to
$60.4 million for the full-year 2019.
Net Loss
Net loss for the fourth quarter of 2020 was $14.4 million, or
$0.09 per basic and diluted share, compared to a net loss of $16.9
million, or $0.12 per basic and diluted share, for the fourth
quarter of 2019. Full-year 2020 net loss was $59.9 million, or
$0.37 per basic and diluted share, compared to $71.2 million, or
$0.51 per basic and diluted share, for the same period in 2019.
Balance Sheet
At December 31, 2020, the Company had cash, cash equivalents and
short-term investments of $133.6 million, compared to $85.7 million
at December 31, 2019.
At December 31, 2020, the Company had approximately $39.6
million in outstanding term loan debt and $8.5 million of
borrowings under its revolving loan credit agreement, compared to
$39.4 million in outstanding term loan debt and $5.0 million of
borrowings under its revolving loan credit agreement at December
31, 2019.
2021 Product Revenue Guidance
The Company expects 2021 product revenue to be in the range of
$106 million to $110 million. The guidance range represents
approximately 15% to 20% growth compared to 2020 reported product
revenue.
QUARTERLY CONFERENCE CALL
The Company will host a conference call at 4:30 P.M. EDT this
afternoon, during which management will discuss the Company’s
financial results and provide a general business overview and
outlook. To listen to 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 1267389. The replay will be available
approximately three hours after the call through March 11,
2021.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System 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. For more information
about Cerus, visit www.cerus.com and follow us on LinkedIn.
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’ 2021 annual product revenue guidance; Cerus’
formation of a joint venture with
Shandong Zhongbaokang Medical (ZBK) and its intent to develop,
register, manufacture and commercialize the INTERCEPT Blood System
for platelets and red blood cells in China; the anticipated launch of the
INTERCEPT Blood System for Cryoprecipitation; the advancement of
Cerus’ pipeline programs and
Cerus’ efforts to offer its complete INTERCEPT product portfolio
for the market; the total potential value of Cerus’ agreement with
BARDA; and other statements that are not historical
fact.; 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 2021 annual
product revenue guidance, (b) effectively launch and commercialize
the INTERCEPT Blood System for Cryoprecipitation, (c) grow sales
globally, including in its U.S. and European markets, and/or
realize expected revenue contribution resulting from its U.S. and
European market agreements, (d) 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 (e) realize any revenue contribution from its
pipeline product candidates, whether due to Cerus’ inability to
obtain regulatory approval of its pipeline programs, or otherwise;
risks associated with the ultimate duration and severity of the
COVID-19 pandemic and resulting global economic and financial
disruptions, and the current and potential future negative impacts
to Cerus’ business operations and financial results such as the
current and potential additional disruptions to the U.S. and EMEA
blood supply resulting from the evolving effects of the COVID-19
pandemic; risks associated with Cerus’ lack of commercialization
experience with the INTERCEPT Blood System for Cryoprecipitation
and in the United States generally, 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 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 and, as it relates to
the joint venture, ZBK’s ability, to demonstrate to the transfusion
medicine community and other health care constituencies that
pathogen reduction, including PR-Cryo FC for the treatment and
control of bleeding, and the INTERCEPT Blood System is safe,
effective and economical; risks related to Cerus’ ability to
maintain its joint venture with ZBK and to achieve its intended
benefits; Cerus’ ultimate reliance on ZBK and the joint venture to
develop, seek regulatory approval for, and if approved, to market,
sell, distribute and maintain the INTERCEPT Blood System for
platelets and red blood cells in China; risks related to the
uncertain and time-consuming development and regulatory process,
including the risks that (a) Cerus may be unable to comply with the
FDA’s post-approval requirements for the INTERCEPT Blood System,
including by successfully completing required post-approval
studies, which could result in a loss of U.S. marketing approval(s)
for the INTERCEPT Blood System, (b) manufacturing site Biologics
License Applications necessary for Cerus to begin distributing the
INTERCEPT Blood System for Cryoprecipitation may not be obtained in
a timely manner or at all, (c) the INTERCEPT Blood System for
platelets and red blood cells may not receive the requisite
regulatory approvals to be commercialized in China in a timely
manner or at all, and (d) that Cerus may otherwise be unable to
obtain the requisite regulatory approvals to advance its pipeline
programs and bring them to market in a timely manner or at all;
risks associated with Cerus’ lack of experience in marketing
products directly to hospitals and expertise complying with
regulations governing finished biologics; 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 that may
adversely affect the availability of funding under Cerus’ BARDA
agreement and/or BARDA’s exercise of any potential subsequent
option periods, including in connection with the general economic
environment and uncertainty associated with the evolving effects of
the COVID-19 pandemic, such that the anticipated activities that
Cerus expects to conduct with the funds available from BARDA may be
further 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 continued or more severe weakening in
economic conditions resulting from the evolving effects of the
COVID-19 pandemic or otherwise 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, secure
manufacturing supply chain, including the risks that (a) Cerus’
supply chain could be negatively impacted as a result of the
evolving effects of the COVID-19 pandemic, (b) Cerus’ manufacturers
could be unable to comply with extensive FDA and foreign regulatory
agency requirements, and (c) Cerus may be unable to maintain its
primary kit manufacturing agreement and its other supply agreements
with its third party suppliers; Cerus’ ability to identify and
obtain additional partners to manufacture the INTERCEPT Blood
System for Cryoprecipitation; risks associated with Cerus’ ability
to meet its debt service obligations and its need for additional
funding; 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
under the heading “Risk Factors” in Exhibit 99.1 to Cerus’ Current
Report on Form 8-K, filed with the SEC on December 11, 2020. In
addition, to the extent that the COVID-19 pandemic adversely
affects Cerus’ business and financial results, it may also have the
effect of heightening many of the other risks and uncertainties
described above. Cerus disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this
press release.
Supplemental Tables
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020 vs. 2019
2020 vs. 2019
Platelet Kit Growth
U.S.
76%
62%
Rest of World
10%
-3%
Worldwide
34%
19%
Change in Calculated Number of
Treatable Platelet Doses*
U.S.
68%
53%
Rest of World
17%
3%
Worldwide
34%
18%
* Dose treated calculation based on the
number of kits sold and the product configuration (single, double,
and triple dose kits)
CERUS CORPORATION
PRODUCT REVENUE BY
REGION
(in thousands, except
percentages)
Three Months Ended
Twelve Months Ended
December 31,
Change
December 31,
Change
2020
2019
$
%
2020
2019
$
%
Europe, Middle East and Africa
$
16,217
$
14,292
$
1,925
13
%
$
57,427
$
52,499
$
4,928
9
%
North America
11,438
6,435
5,003
78
%
32,380
20,936
11,444
55
%
Other
544
190
354
186
%
2,113
1,214
899
74
%
Total product revenue
$
28,199
$
20,917
$
7,282
35
%
$
91,920
$
74,649
$
17,271
23
%
CERUS CORPORATION
CONDENSED CONSOLIDATED
UNAUDITED STATEMENTS OF OPERATIONS
(in thousands, except per
share information)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019*
Product revenue
$
28,199
$
20,917
$
91,920
$
74,649
Cost of product revenue
12,179
9,293
41,157
33,419
Gross profit on product revenue
16,020
11,624
50,763
41,230
Government contract revenue
5,391
5,571
22,329
19,125
Operating expenses:
Research and development
17,061
16,438
64,410
60,376
Selling, general and administrative
18,691
17,164
67,015
66,205
Total operating expenses
35,752
33,602
131,425
126,581
Loss from operations
(14,341
)
(16,407
)
(58,333
)
(66,226
)
Total non-operating income (expense),
net
52
(434
)
(1,240
)
(4,755
)
Loss before income taxes
(14,289
)
(16,841
)
(59,573
)
(70,981
)
Provision for income taxes
92
82
284
263
Net loss
$
(14,381
)
$
(16,923
)
$
(59,857
)
$
(71,244
)
Net loss per share:
Basic and diluted
$
(0.09
)
$
(0.12
)
$
(0.37
)
$
(0.51
)
Weighted average shares used for
calculating net loss per share:
Basic and diluted
167,372
142,952
163,949
139,831
* Derived from the audited
consolidated financial statements.
CERUS CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,
December 31,
2020
2019*
ASSETS
(unaudited)
Current assets:
Cash and cash equivalents
$
36,594
$
34,986
Short-term investments
97,000
50,732
Accounts receivable
21,166
16,882
Inventories, net
23,254
19,490
Prepaid and other current assets
5,417
6,018
Total current assets
183,431
128,108
Non-current assets:
Property and equipment, net
13,867
14,898
Goodwill and intangible assets, net
1,316
1,448
Operating lease right-of-use assets
13,122
14,122
Restricted cash and other assets
9,679
6,959
Total assets
$
221,415
$
165,535
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable and accrued
liabilities
$
48,966
$
43,136
Debt – current
8,516
5,017
Operating lease liabilities – current
1,915
1,613
Deferred product revenue – current
577
570
Total current liabilities
59,974
50,336
Non-current liabilities:
Debt – non-current
39,588
39,414
Operating lease liabilities –
non-current
16,873
18,406
Other non-current liabilities
1,174
327
Total liabilities
117,609
108,483
Stockholders' equity:
103,806
57,052
Total liabilities and stockholders'
equity
$
221,415
$
165,535
* Derived from the audited
consolidated financial statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210225006077/en/
Matt Notarianni – Senior Director, Investor Relations Cerus
Corporation 925-288-6137
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