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to Cerus Current Report on Form 8-K, filed with the SEC on

Key Takeaway: Cerus Corporation Announces Record Fourth Quarter and Full Year 2020 Financial Results CONCORD, CA, February 25, 2021 Cerus Corporation (Nasdaq: CERS) today announced financial results for the fourth quarter and year ended Recent developments and highlights include: Revenue by

Full Press Release Details

Cerus Corporation Announces Record Fourth Quarter and Full Year 2020 Financial Results
CONCORD, CA, February 25, 2021 Cerus Corporation (Nasdaq: CERS) today announced financial results for the fourth quarter and year ended
Recent developments and highlights include:
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 %
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.
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 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 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
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 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.
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.
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.
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
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.
Matt Notarianni Senior Director, Investor Relations
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 %
PRODUCT REVENUE BY REGION
(in thousands, except percentages)
Three Months Ended December 31, Change Twelve Months Ended 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 %
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
CONDENSED CONSOLIDATED BALANCE SHEETS
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
Last updated: Feb 25, 2021