Cerus Corporation Announces Record Third Quarter 2020 Results CONCORD, CA

Cerus Corporation Announces Record Third Quarter 2020 Results

CONCORD, CA, Oct 29, 2020 - Cerus Corporation (Nasdaq: CERS) today announced financial results for the third quarter ended September 30, 2020.

Recent developments and highlights include:

We are pleased to report another record quarter with U.S. platelet kit sales fueling top line growth as blood centers and

hospitals continue to embrace the INTERCEPT Blood System to comply with the FDA guidance on bacterial safety, said William Obi Greenman, Cerus president and chief executive officer. While

COVID-19 has successfully underscored the global importance of pathogen reduction for pandemic

preparedness, the potential for additional disruptions to the blood supply this fall and winter leads us to narrow our 2020 guidance range due to recent sharp rises in new COVID cases in certain

regions, including Europe. We remain confident in our longer term growth opportunities, especially in the U.S. and with an anticipated continued increase in INTERCEPT adoption even beyond the March 2021 FDA compliance deadline.

Product revenue during the third quarter of 2020

was $23.6 million, compared to $18.0 million during the same period in 2019, an increase of 31%. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand in

our EMEA region. Year-to-date product revenue totaled $63.7 million, an increase of 19% compared to the same period in 2019.

Government contract revenue from the Company s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.6 million during the

third quarter of 2020, compared to $4.8 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities.

Year-to-date government contract revenue totaled $16.9 million, compared to $13.6 million during the first three quarters of 2019. The total potential value of

the current BARDA agreement is $214 million with $61 million recognized as revenue to date. The Company has not yet recognized any revenue to date from the recently awarded whole-blood pathogen reduction FDA contract.

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 partially 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 third quarter of 2020 were 54% compared to 58% in the prior year period. Gross margins during the quarter were

negatively impacted by an $870,000 non-routine period charge tied to certain inventoried components that failed to meet the Company s quality standards. This

non-routine period charge negatively impacted Q3 2020 gross margins by 3.7 percentage points. Gross margins during the first nine months of 2020 were 55% and consistent with those reported in the same period

expenses for the third quarter of 2020 were $32.2 million and essentially flat compared with the same period during the prior year. Year to date, operating expenses totaled $95.7 million compared to $93.0 million for the first nine

Selling, general, and administrative (SG&A) expenses for the third quarter of 2020 totaled $16.3 million, compared to

$16.1 million for the third quarter of 2019. Year-to-date SG&A expenses totaled $48.3 million compared to $49.0 million for the first nine months of

Research and development (R&D) expenses for the third quarter of 2020 were $15.9 million, compared to $16.1 million for the third

quarter of 2019. Year-to-date R&D

expenses totaled $47.3 million compared to $43.9 million for the first nine months of 2019 with the increase primarily tied to costs related to the red blood cell program as well as

increased costs tied to product enhancements and expanded label claims for INTERCEPT-treated platelets.

Net loss for the third quarter of 2020 was $14.1 million, or $0.08 per diluted share, compared to a net loss of $18.0 million, or $0.13 per diluted

share, for the third quarter of 2019. Year-to-date net loss was $45.5 million, or $0.28 per diluted share, compared to $54.3 million, or $0.39 per diluted

share, in the first nine months of 2019.

Cash, Cash Equivalents and Investments

At September 30, 2020, the Company had cash, cash equivalents and short-term investments of $135.1 million, compared to $85.7 million at

At September 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to

$39.4 million in outstanding term loan debt at December 31, 2019.

2020 Product Revenue Guidance

The Company is narrowing its previously stated product revenue guidance range. The Company expects 2020 product revenue to be in the range of $89 million

to $91 million, compared to our previous guidance range of $89 million to $93 million.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast 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 and view the presentation slides, please visit the Investor Relations page of the Cerus website at 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 7249794. The replay will be available approximately three hours after the call through November 12, 2020.

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

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 2020 annual product revenue guidance, including

Cerus reasons for narrowing its 2020 annual product revenue guidance; Cerus belief in its longer term growth opportunities, including its expectation of continued increase in INTERCEPT adoption beyond the March 2021 FDA compliance

deadline; the total potential value of Cerus agreement with BARDA; 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 2020 annual product revenue guidance,

(b) 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, (c) 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

(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 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 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; risks related to the uncertain and time-consuming development and regulatory process, including the risks (a) that the INTERCEPT Blood

System does not have approved label claims for SARS-CoV-2 inactivation and may not successfully inactivate SARS-CoV-2; (b) that convalescent plasma therapies are unproven in treating, and may be ineffective in treating, patients with COVID-19, (c) that Cerus will continue to

experience delays in successfully initiating, conducting or completing clinical trials as a result of the COVID-19 pandemic, (d) 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, (e) that Cerus

may be unable to obtain U.S. marketing or CE Mark approvals, or any other regulatory approvals, of the INTERCEPT red blood cell system in a timely manner or at all, (f) 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 pathogen-reduced cryoprecipitated fibrinogen complex, which will require additional regulatory approvals, (g) that Cerus premarket approval

supplement (PMA-S) for pathogen-reduced cryoprecipitated fibrinogen complex may not be accepted or approved in a timely manner or at all, (h) 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, including Cerus PMA-S for pathogen-reduced

cryoprecipitated fibrinogen complex, in a timely manner or at all, and (i) that even if Cerus regulatory submissions are approved, Cerus may not receive label claims for all requested indications or for indications with the highest unmet

need or market acceptance; 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

negative 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 pathogen-reduced

cryoprecipitate; 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 Cerus Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on

August 4, 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.

Tim Lee Investor Relations Director

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