www.cerus.com<\/a> and follow us on LinkedIn.<\/p>\n\nINTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.<\/p>\n
Forward Looking Statements<\/b><\/p>\n
\nExcept for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus\u2019 products, prospects and expected results, including statements relating to Cerus\u2019 2023 annual product revenue guidance; Cerus\u2019 ability to return to growth for the duration of 2023; Cerus\u2019 expectations regarding continued adoption of its products in non-US geographies in 2023; Cerus\u2019 ability to meet commercial milestones in 2023, including the ongoing roll-out of INTERCEPT platelets in Canada and regulatory progress in China via its joint venture; Cerus\u2019 ability to reinvest in continued growth, including margin expansion and scale and new product development; Cerus\u2019 expectations regarding the U.S. customer inventory drawdown having been largely completed; Cerus\u2019 expectations regarding continued margin expansion; Cerus\u2019 access to $17 million under its revolving line of credit; 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 2023 annual product revenue guidance, (b) effectively continue to 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\u2019 commercial agreements with these customers, (e) effectively expand its commercialization activities into additional geographies and\/or (f) realize any revenue contribution from its pipeline product candidates, whether due to Cerus\u2019 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\u2019 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\u2019 lack of longer-term 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 the highly concentrated market for the INTERCEPT Blood System; risks related to how any future platelet additive solution (PAS) supply disruption could affect INTERCEPT\u2019s acceptance in the marketplace; risks related to how any future PAS supply disruption might affect current commercial contracts; risks related to Cerus\u2019 ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction, including IFC for the treatment and control of bleeding, 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 that (a) Cerus may be unable to comply with the FDA\u2019s 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) additional manufacturing site Biologics License Applications necessary for Cerus to more broadly distribute the INTERCEPT Blood System for Cryoprecipitation may not be obtained in a timely manner or at all, (c) Cerus may be unable to complete enrollment in its ReCePI and RedeS studies in a timely manner or at all, and (d) Cerus may 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 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, rising interest rates, inflation or otherwise in the markets where Cerus currently sells and is anticipated to sell its products; Cerus\u2019 reliance on third parties to market, sell, distribute and maintain its products; Cerus\u2019 ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus\u2019 supply chain could be negatively impacted as a result of the evolving impact of macroeconomic developments, including the ongoing conflict in Ukraine and the evolving effects of the COVID-19 pandemic, (b) Cerus\u2019 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\u2019 ability to identify and obtain additional partners to manufacture the INTERCEPT Blood System for Cryoprecipitation; risks associated with Cerus\u2019 ability to access additional funds under its revolving line of credit and 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\u2019 future capital requirements and its future revenues and other financial performance and results, as well as other risks detailed in Cerus\u2019 filings with the Securities and Exchange Commission, including under the heading \u201cRisk Factors\u201d in Cerus\u2019 Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.<\/p>\n
Use of Non-GAAP Financial Measures<\/b><\/p>\n
\nCerus has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including adjusted EBITDA. We define adjusted EBITDA as net income (loss) attributable to Cerus Corporation as reported on the consolidated statement of operations, as adjusted to exclude (i) net income (loss) attributable to noncontrolling interest, (ii) provision for (benefit from) income taxes, (iii) foreign exchange (loss)\/gain, (iv) interest expense, (v) other income (expense), net (vi) depreciation and amortization, (vii) share-based compensation, (viii) goodwill and asset impairments, (ix) costs associated with our noncontrolling interest in our joint venture in China, and (x) revenue and direct costs associated with our government contracts. We are presenting this non-GAAP financial measure to assist investors in assessing our operating results. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Cerus\u2019 GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Cerus\u2019 operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly-titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables.<\/p>\n
Supplemental Tables<\/b><\/p>\n\n\n| \n \n\u00a0<\/p>\n<\/td>\n | \n Three Months Ended<\/b><\/p>\n<\/td>\n<\/tr>\n\n | \n\n March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n\n | \n\n 2023 vs. 2022<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n Platelet Kit Growth<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \nNorth America<\/p>\n<\/td>\n | \n \n-28%<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nInternational<\/p>\n<\/td>\n | \n \n-5%<\/p>\n<\/td>\n<\/tr>\n | \n| \n Worldwide<\/b><\/p>\n<\/td>\n | \n -21%<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n Change in Calculated Number of Treatable Platelet Doses*<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \nNorth America<\/p>\n<\/td>\n | \n \n-30%<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nInternational<\/p>\n<\/td>\n | \n \n-7%<\/p>\n<\/td>\n<\/tr>\n | \n| \n Worldwide<\/b><\/p>\n<\/td>\n | \n -22%<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \n* Dose treatable calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits)<\/p>\n<\/td>\n<\/tr>\n<\/table>\n | | | | | | | |
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