Financial Data and Key Metrics Changes - Product revenues for Q2 2022 reached $41 million, reflecting a year-over-year growth of 30% [26] - Net loss attributable to Cerus for Q2 2022 was $8.4 million, a significant reduction from $15.4 million in the same period of 2021 [35] - Non-GAAP adjusted EBITDA improved to negative $2.4 million in Q2 2022, compared to negative $8.2 million in Q2 2021 [36] Business Line Data and Key Metrics Changes - North American product sales increased by 75% year-over-year, significantly contributing to overall revenue growth [18] - The calculated number of treatable platelet doses grew by 65% year-over-year in the U.S. and 22% internationally for Q2 2022 [29] - INTERCEPT disposable kits accounted for over 96% of Q2 product revenue [30] Market Data and Key Metrics Changes - EMEA region experienced positive growth despite currency headwinds, particularly in the Middle East [20] - The strengthening U.S. dollar posed a 6% headwind to top-line revenue for the quarter [57] Company Strategy and Development Direction - The company aims to make INTERCEPT the standard of care in transfusion medicine globally, with a focus on expanding patient access [10] - Plans to self-fund future growth as the company approaches cash flow breakeven [16] - Continued emphasis on building a strong body of evidence around INTERCEPT Fibrinogen Complex's utility [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit product revenue growth in the second half of 2022 despite economic headwinds [40] - The company reiterated its full-year 2022 product revenue guidance range of $160 million to $165 million, reflecting year-over-year growth of 22% to 26% [41] Other Important Information - The company is progressing with its INTERCEPT red blood cell efforts, with ongoing Phase III trials [42] - The review process for the European regulatory submission for INTERCEPT red blood cells has commenced [49] - Dr. Hua Shan was welcomed to the Board, bringing expertise in blood safety and pathogen reduction [54] Q&A Session Summary Question: What was the FX impact on the top line in the quarter? - The company experienced about a 6% headwind from FX for the quarter, with expectations of 3 to 4 million dollars in incremental FX impact for the back half of the year [57][58] Question: How should the third quarter be viewed in terms of seasonality? - Management indicated that while there are headwinds, underlying product growth remains robust, and they do not provide quarterly guidance [60][62] Question: What is resonating most in terms of uptake for IFC? - Early availability and lower wastage rates are key factors driving interest among clinicians [73][75] Question: What changes are expected to accelerate adoption of IFC? - The company aims to increase awareness through case studies and registry data, while overcoming staffing challenges in hospitals [78] Question: Are timelines for submitting INTERCEPT Platelets to the NMPA still intact? - The company remains on track for submission before the end of the year despite challenges from COVID lockdowns [81] Question: How is the inflationary environment impacting the business? - The company is managing price increases and does not foresee alarming impacts on reaching adjusted EBITDA neutrality [83]

Regulatory Approvals and Product Development - The INTERCEPT Blood System has received regulatory approvals including FDA approval and CE Certificates for its platelet and plasma systems, allowing sales in multiple regions including the U.S. and Europe[107] - The red blood cell system is still in development, with a CE Certificate application submitted in December 2018, and a decision is not expected for at least another 12 months[109] - In June 2022, the company extended its agreement with BARDA through December 2025, providing funding for the development of the red blood cell system and related clinical programs[112] - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020, with the first sale of IFC completed in 2021[113] Financial Performance - Product revenue for the three months ended June 30, 2022, was $40,999, a 30% increase from $31,484 in the same period of 2021, driven by sales volume growth in disposable platelet system kits[133] - Total revenue for the six months ended June 30, 2022, was $90,651, representing a 34.6% increase from $67,329 in the same period of 2021[133] - Government contract revenue for the six months ended June 30, 2022, was $12,208, slightly down from $12,466 in the same period of 2021, indicating stability in government contracts despite COVID-19 impacts[134] Cost and Expenses - Cost of product revenue for the three months ended June 30, 2022, was $19,718, a 29% increase from $15,323 in the same period of 2021, primarily due to increased sales volume and foreign exchange impacts[135] - Gross margin on product sales was 52% for both the three and six months ended June 30, 2022, consistent with the same periods in 2021[135] - Research and development expenses decreased by 11% to $15,216,000 for the three months ended June 30, 2022, compared to $17,083,000 for the same period in 2021[139] - Selling, general and administrative expenses remained relatively flat at $19,532,000 for the three months ended June 30, 2022, compared to $19,758,000 for the same period in 2021, but increased by 3% to $40,267,000 for the six months ended June 30, 2022, compared to $38,928,000 for the same period in 2021[142] Cash Flow and Liquidity - Total cash and cash equivalents decreased to $32,309,000 as of June 30, 2022, from $48,759,000 as of December 31, 2021[151] - Total short-term investments decreased to $74,738,000 as of June 30, 2022, from $80,600,000 as of December 31, 2021[151] - Net cash used in operating activities improved to $(21,801,000) for the six months ended June 30, 2022, compared to $(26,118,000) for the same period in 2021[154] - Working capital decreased to $85,393,000 as of June 30, 2022, from $108,546,000 as of December 31, 2021, primarily due to cash usage for product enhancements and inventory[156] Funding and Capital Needs - The company has borrowed capital and may seek additional funding through various agreements, which could involve restrictive covenants and potential dilution for shareholders[114] - The BARDA agreement could provide up to $246.5 million in funding through December 31, 2025, contingent on meeting certain milestones[126] - The company expects to receive significant funding under the agreement with BARDA, but this is subject to various risks, including the ability to achieve required milestones and potential termination of the agreement[163] - The company may need to obtain additional funds to complete development activities for the red blood cell system necessary for potential regulatory approval in the EU[168] Market and Economic Conditions - Economic conditions, including inflation and rising interest rates, may negatively affect the company's liquidity and operational costs[115] - The company faces potential cost pressures due to inflation, increased transportation costs, and supply chain inefficiencies, which could impact future gross margins[135] - The general economic environment and uncertainty associated with the COVID-19 pandemic have led to a decline in available government funding, impacting the company's revenue and cash flows[163] Operational Challenges - The company is facing potential delays in clinical trials due to the COVID-19 pandemic, which could impact the timeline for regulatory approvals[111] - The company is actively monitoring the impacts of the COVID-19 pandemic on its operations, which may affect product revenues and clinical trials[130] - The company continues to invest in inventory to meet future demand and mitigate supply chain disruptions[139] - The company may need to curtail planned development or commercialization activities if unable to raise additional capital due to volatile global financial markets[165] Shareholder Considerations - The company has sold 0.4 million shares of common stock under the Sales Agreement for net proceeds of $3.1 million, out of a potential $100.0 million[162] - The company may experience substantial dilution if it raises additional capital by issuing equity securities[161] Interest and Non-Operating Expenses - Interest expense increased by 18% to $(2,728,000) for the six months ended June 30, 2022, compared to $(2,310,000) for the same period in 2021[147] - Non-operating expenses increased by 114% to $(3,842,000) for the six months ended June 30, 2022, compared to $(1,795,000) for the same period in 2021[144] Foreign Exchange and Hedging - The company does not currently enter into any hedging contracts to mitigate foreign exchange fluctuations, which could materially affect future results[164]

Financial Data and Key Metrics Changes - Product revenues for Q1 2022 reached $37.4 million, reflecting a year-over-year growth of 60% [25] - Gross profit for Q1 was $19.4 million, an increase of 58% year-over-year compared to $12.3 million in the prior year [29] - The net loss attributable to the company for Q1 2022 decreased to $12.3 million or $0.07 per diluted share, compared to $17.5 million or $0.10 per diluted share for the same period in 2021 [33] - The company raised its 2022 product revenue guidance from $157 million to $164 million to a new range of $160 million to $165 million, indicating a year-over-year growth of 22% to 26% [37] Business Line Data and Key Metrics Changes - Strong growth in the U.S. platelet business, which was up over 130% year-over-year [14] - The calculated number of treatable platelet doses in the U.S. increased by 141% year-over-year, while international growth was 28% [28] - Sales of INTERCEPT disposable kits represented nearly 98% of Q1 product revenue [28] Market Data and Key Metrics Changes - North America led sales growth with a 130% increase year-over-year, with Q1 revenue in North America nearly matching total global product revenue from Q1 2021 [26] - EMEA region saw an 11% year-over-year growth, and 19% growth when excluding negative foreign currency impacts [27] Company Strategy and Development Direction - The company is focused on establishing a new safety standard in transfusion medicine, expanding access to INTERCEPT treated blood components [10] - Plans to diversify growth with the nationwide launch of INTERCEPT Fibrinogen Complex (IFC) across the U.S. [15] - The company aims to increase manufacturing capacity to meet growing demand and improve cost profiles through new agreements [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for INTERCEPT products despite geopolitical and economic uncertainties [13] - The company is optimistic about the future growth trajectory, particularly with the anticipated increase in demand for Fibrinogen and the successful rollout of IFC [17][39] - Management highlighted the importance of the American Red Cross contract extension for future demand forecasting and operational planning [20][51] Other Important Information - The company reported a non-GAAP adjusted EBITDA of negative $3.7 million for Q1 2022, an improvement from negative $11.5 million in Q1 2021 [35] - Cash and cash equivalents at the end of Q1 2022 stood at $108.6 million, indicating a strong cash position [36] Q&A Session Summary Question: FX impact in Q1 and guidance adjustments - The FX impact for Q1 was approximately $1 million, with adjustments made in the new guidance to account for currency fluctuations [48] Question: Red Cross contract implications - The contract extension with the American Red Cross enhances demand management and operational planning, providing greater visibility for future growth [49][51] Question: International market opportunities - The company is pursuing opportunities in Canada and Germany, with expectations for progress in these markets over the next few years [61][62] Question: IFC launch timeline - The IFC product is expected to gain traction in 2023, with ongoing efforts to engage hospitals and clinicians [64][66]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Commission File Number 000-21937 | --- | --- | --- | |--------------------------------------------------------------------------------------|----------- ...

Cerus Corporation (NASDAQ:CERS) Q4 2021 Results Conference Call February 22, 2022 4:30 PM ET Company Participants Matt Notarianni - Senior Director, IR Obi Greenman - President and CEO Kevin Green - CFO Carol Moore - SVP, Regulatory Affairs and Quality Jessica Hanover - VP, Corporate Affairs Conference Call Participants Josh Jennings - Cowen Jacob Johnson - Stephens Brandon Folkes - Cantor Fitzgerald Operator Good day, ladies and gentlemen. Thank you for standing by. And welcome to the Cerus Corporation Fou ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |---------------------------------------------------------------------|-------------------------------------------------------------------------------- ...

Financial Data and Key Metrics Changes - Cerus Corporation reported record product revenue of $36.1 million for Q3 2021, representing a 53% year-over-year increase and a 15% sequential growth from Q2 2021 [18][25] - Year-to-date product revenues at the end of Q3 were only about $1 million shy of the full year 2020 product revenues, indicating strong growth momentum [26] - Gross profit for Q3 reached $18.5 million, the highest in the company's history, compared to $12.7 million in the prior year [30] - The net loss attributable to Cerus improved to $12.4 million, or $0.07 per diluted share, compared to a net loss of $14.1 million, or $0.08 per diluted share, in the prior year [37] Business Line Data and Key Metrics Changes - Product sales in North America grew 146% year-over-year, while EMEA sales grew 3% [19] - Sales to the top five US blood centers increased over 170% compared to Q3 2020, contributing significantly to overall revenue growth [20] - INTERCEPT platelet kits represented over 80% of total product sales, with cumulative kit sales recently surpassing 10 million doses globally [14][27] Market Data and Key Metrics Changes - The US platelet market is experiencing mid-single digit organic growth, creating demand for efficient supply chain solutions [51] - The INTERCEPT blood system is becoming the standard of care in the US platelet market, with INTERCEPT treated platelets now representing the majority of platelets produced [12][62] Company Strategy and Development Direction - The company aims to establish the INTERCEPT blood system as the global standard of care in transfusion medicine, focusing on expanding its market presence and product adoption [15][47] - Cerus is committed to advancing its pipeline, with several important product launches anticipated in the coming years [47] - The company plans to strip out government contract revenue and expenses from its financial metrics to highlight core business performance [29] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about continued growth in 2022, driven by the size of the market and the increasing adoption of INTERCEPT products [51] - The company is focused on achieving cash flow breakeven while investing in growth for both the short and long term [38] - The ongoing blood supply shortage in the US is a concern, but it is not expected to significantly impact Cerus's immediate growth trajectory [59] Other Important Information - The company has signed a multiyear contract extension with EFS, France's national transfusion service, validating its business model and commitment to blood safety [46] - The INTERCEPT Fibrinogen Complex (IFC) product has seen initial commercial sales, with plans for a nationwide rollout pending regulatory approvals [21][24] Q&A Session Summary Question: What is the sustainable growth trajectory for Cerus going into 2022 and 2023? - Management expressed confidence in sustaining growth domestically and internationally, citing strong demand from blood centers and hospitals for INTERCEPT treated platelets [50][52] Question: Can you provide updates on the INTERCEPT Fibrinogen Complex and its market potential? - The total addressable market for IFC is estimated at $300 million in the US, with growth driven by increased use of fibrinogen concentrates in surgical procedures [53][54] Question: How is the company addressing the blood shortage in the US? - Management noted that the blood shortage continues but does not significantly impact Cerus's growth trajectory, emphasizing the need for increased platelet supply [59] Question: What are the expectations for gross margins moving forward? - Gross margins are expected to remain stable in the near term, with potential for expansion as the company increases production efficiency and shifts to double dose kits [60][72] Question: What is the status of the red blood cell studies and expected launch timelines? - Enrollment for the Phase III studies is ongoing, with updates expected in the first half of 2022, while a product launch in Europe is anticipated in 2023 [77][78]

Product Development and Approvals - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020, and sales began in Q3 2021, primarily targeting hospitals [125]. - The red blood cell system is currently in development, with CE Mark application resubmitted under the new European Medical Device Regulation as of June 2021, but approval is not expected within the next twelve months [124]. - The company has extended its agreement with BARDA through December 2023, which provides funding for the development of the red blood cell system and related clinical programs [124]. - The platelet system is approved in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components, with two post-approval studies required by the FDA [122]. - The plasma system is approved for ex vivo preparation of pathogen-reduced plasma, aimed at reducing the risk of transfusion-transmitted infection [122]. - The company may need to generate additional safety data from commercial use to achieve broader market acceptance for the red blood cell system [124]. Financial Performance - Product revenue for the three months ended September 30, 2021, was $36,131,000, a 53% increase from $23,607,000 in the same period of 2020 [146]. - Total revenue for the nine months ended September 30, 2021, was $109,430,000, representing a 36% increase from $80,659,000 in the same period of 2020 [146]. - Government contract revenue for the three months ended September 30, 2021, was $5,970,000, a 7% increase from $5,584,000 in the same period of 2020 [147]. - Cost of product revenue for the three months ended September 30, 2021, was $17,582,000, a 61% increase from $10,953,000 in the same period of 2020 [149]. - Gross margin on product sales for the three months ended September 30, 2021, was 51%, down from 54% in the same period of 2020 [151]. - The company anticipates increased product revenue from INTERCEPT disposable kits due to expanded U.S. sales and market acceptance [146]. Expenses and Cash Flow - Research and development expenses for the three months ended September 30, 2021, decreased by 4% to $15,288, compared to $15,921 for the same period in 2020, while expenses for the nine months increased by 2% to $48,119 from $47,349 [154]. - Selling, general, and administrative expenses increased by 25% to $20,357 for the three months ended September 30, 2021, compared to $16,299 in the same period of 2020, and increased by 23% to $59,285 for the nine months from $48,324 [158]. - Total non-operating expense, net for the three months ended September 30, 2021, was $(1,238), a significant increase of 1,291% compared to $(89) in the same period of 2020 [160]. - As of September 30, 2021, cash and cash equivalents totaled $78,460, short-term investments were $41,501, and total liquidity amounted to $122,239, compared to $135,903 as of December 31, 2020 [167]. - The company incurred a net cash used in operating activities of $(32,700) for the nine months ended September 30, 2021, which remained relatively flat compared to $(32,910) for the same period in 2020 [168]. - Net cash provided by investing activities was $52,978 for the nine months ended September 30, 2021, compared to $(57,160) for the same period in 2020 [169]. - Net cash provided by financing activities decreased to $22,196 for the nine months ended September 30, 2021, from $83,496 in the same period of 2020 [171]. Capital and Funding - The BARDA agreement could provide up to $223.5 million in funding through December 31, 2023, contingent on meeting certain milestones [138]. - The company is responsible for co-investment of approximately $5.0 million under the BARDA agreement, with potential additional responsibilities if further options are exercised [138]. - The company expects to meet its capital requirements for at least the next 12 months based on available cash, cash equivalents, and short-term investments [175]. - The company has the potential to issue and sell up to $100.0 million of common stock under a Sales Agreement, but has not yet sold any shares [177]. - The company may need to borrow additional capital from institutional and commercial banking sources, which could include restrictive covenants and high effective interest rates [176]. - The company’s ability to obtain expected funding from BARDA is subject to risks, including the potential for funding to be reduced or delayed due to the COVID-19 pandemic [178]. Market and Economic Conditions - The company is actively working to identify additional manufacturing partners for the INTERCEPT Blood System for Cryoprecipitation, which may create pricing pressures and competition for hospital business [125]. - The company is facing risks related to the COVID-19 pandemic, which may impact trial enrollment and regulatory approvals [124]. - The COVID-19 pandemic continues to affect business operations, potentially delaying research and development activities and impacting overall financial projections [143]. - The company faces potential impacts on product revenues due to fluctuations in the Euro relative to the U.S. dollar, as a significant portion of revenue is expected from Euro-denominated markets [146]. - Foreign exchange losses were reported at $(164) for the three months ended September 30, 2021, compared to gains of $490 in the same period of 2020, primarily due to unfavorable currency variations [161]. - The general economic environment and uncertainty from the COVID-19 pandemic may limit the company’s ability to access capital, negatively affecting liquidity [182]. Risk Management - The company does not currently enter into hedging contracts to mitigate foreign exchange fluctuations, which could materially affect future results [181]. - The company may need additional funds for the development of the red blood cell system in Europe if costs exceed expectations or delays occur [183]. - The company has not recorded any credit losses during the three and nine months ended September 30, 2021 [185]. - The company’s investment policy focuses on preserving principal and liquidity while maximizing returns to support operations [185]. - The company has no off-balance sheet arrangements as of September 30, 2021 [184].

Cerus Corporation (NASDAQ:CERS) Q2 2021 Earnings Conference Call August 3, 2021 4:30 PM ET Company Participants Matt Notarianni - Senior Director of Investor Relations Obi Greenman - President and Chief Executive Officer Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Carol Moore - Senior Vice President of Regulatory Affairs and Quality Jessica Hanover - Vice President of Corporate Affairs Conference Call Participants Matthew Blackman - Stifel Brandon Folkes - Cantor Fitzgera ...

Regulatory Approvals and Product Development - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020, intended for treatment of bleeding associated with fibrinogen deficiency [122]. - The red blood cell system is currently in development, with CE Mark application resubmitted under the new European Medical Device Regulation, but approval is not expected until 2022 [121]. - The platelet system is approved in the U.S. for pathogen-reduced apheresis platelet components, with two post-approval studies required by the FDA [119]. - The INTERCEPT Blood System has received CE Marks and FDA approval for both platelet and plasma systems, which are marketed in multiple countries [118]. Financial Performance - Product revenue for the three months ended June 30, 2021, was $31.5 million, a 46% increase from $21.5 million in the same period of 2020 [142]. - Total revenue for the six months ended June 30, 2021, reached $67.3 million, up 31% from $51.5 million in the same period of 2020 [142]. - Government contract revenue for the three months ended June 30, 2021, was $6.3 million, an 18% increase from $5.3 million in the same period of 2020 [143]. - The company recognized $12.5 million in government contract revenue for the six months ended June 30, 2021, compared to $11.4 million in the same period of 2020, reflecting ongoing contract activities [143]. Expenses and Financial Challenges - Cost of product revenue for the three months ended June 30, 2021, was $15.3 million, a 58% increase from $9.7 million in the same period of 2020 [146]. - Gross margin on product sales decreased to 51% for the three months ended June 30, 2021, down from 55% for the same period in 2020 [147]. - Research and development expenses increased by 9% to $17,083,000 for the three months ended June 30, 2021, compared to $15,618,000 for the same period in 2020 [150]. - Selling, general, and administrative expenses rose by 23% to $19,758,000 for the three months ended June 30, 2021, compared to $16,112,000 for the same period in 2020 [154]. - Interest expense increased by 44% to $(1,338,000) for the three months ended June 30, 2021, compared to $(929,000) for the same period in 2020 [159]. Cash Flow and Capital Requirements - Total cash and cash equivalents decreased to $59,030,000 as of June 30, 2021, from $36,594,000 as of December 31, 2020 [164]. - Total debt increased to $64,011,000 as of June 30, 2021, compared to $48,104,000 as of December 31, 2020 [165]. - Net cash used in operating activities improved to $(26,118,000) for the six months ended June 30, 2021, from $(27,721,000) for the same period in 2020 [166]. - Net cash provided by investing activities was $31,249,000 for the six months ended June 30, 2021, compared to $(51,780,000) for the same period in 2020 [167]. - Net cash provided by financing activities decreased to $17,615,000 for the six months ended June 30, 2021, from $79,325,000 for the same period in 2020 [169]. - Working capital decreased to $119,775,000 as of June 30, 2021, from $123,457,000 as of December 31, 2020 [170]. - The company expects to meet its capital requirements for at least the next 12 months, relying on cash from product sales and government contracts [172]. Strategic Initiatives and Market Challenges - The company plans to transition to a direct sales model for the INTERCEPT Blood System in the U.S., focusing on hospital customers [118]. - The company is actively seeking additional manufacturing partners for the extended-storage cryoprecipitate product to enhance market reach [122]. - The company may experience pricing pressures and competition for hospital business due to its strategy of selling products to non-manufacturing partner blood centers [122]. - The company plans to begin a limited launch of IFC to U.S. hospital customers this year [142]. - The company faces potential challenges in achieving profitability if widespread commercial adoption of its blood safety products does not occur [129]. Risks and Uncertainties - The company faces risks related to the COVID-19 pandemic, which may delay clinical trial enrollment and regulatory approvals [121]. - The COVID-19 pandemic continues to impact the company's operations and may delay research and development activities [139]. - The company may need to raise additional capital to support the development and regulatory approval of the red blood cell system [121]. - Funding under the agreement with BARDA is subject to risks, including the ability to achieve required milestones and potential termination of the agreement [175]. - The company may need additional funds for the development of the red blood cell system and to conduct clinical trials if costs exceed expectations [180].