Financial Data and Key Metrics Changes - Cerus Corporation reported record Q4 2021 product revenue of $39.9 million, reflecting a year-over-year growth of 41% and a sequential growth of 10% [23] - For the full year 2021, product revenue totaled $130.9 million, a 42% increase compared to 2020 [23] - The net loss attributable to Cerus for Q4 was $9.1 million or $0.05 per diluted share, an improvement from a net loss of $14.4 million or $0.09 per diluted share in the prior year [33] - The full year net loss attributable to Cerus was $54.4 million or $0.32 per diluted share, compared to $59.9 million or $0.37 per diluted share in the prior year [33] Business Line Data and Key Metrics Changes - Sales of INTERCEPT consumable products represented nearly 97% of Q4 product revenue [25] - The calculated number of treatable platelet doses in Q4 reflected a 132% year-over-year increase in the U.S. and a 4% decline internationally [24] - Government contract revenue totaled $10.2 million in Q4 and $28.7 million for the full year, compared to $5.4 million and $22.3 million in the prior year respectively [26] Market Data and Key Metrics Changes - Fourth quarter sales in North America grew by 108% versus the prior year period, while EMEA was roughly flat when adjusting for foreign currency [23] - The global total addressable market (TAM) for INTERCEPT platelets is estimated to be about $1.3 billion, with the U.S. opportunity representing about $150 million [14] Company Strategy and Development Direction - Cerus aims to safeguard the global blood supply and is committed to bringing products to market that protect blood components from known and future threats [12] - The company plans to extend its leadership in currently served markets and penetrate untapped geographies like China, alongside the commercial success of new products [13] - The company is focused on advancing R&D programs to innovate pathogen inactivation and develop enhancements to improve customer experience and cost profile [43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving cash flow breakeven and highlighted the importance of financial discipline in driving growth [38] - The company anticipates strong double-digit growth in 2022, primarily driven by INTERCEPT platelets in the U.S. [37] - Management acknowledged challenges related to COVID-19 impacting hospital access but remains confident in the growth potential of the INTERCEPT product line [72] Other Important Information - The company ended 2021 with $129.4 million in cash and cash equivalents, indicating a strong financial position [34] - Operating expenses for Q4 totaled $37.6 million, with a focus on maintaining expense leverage as revenue grows [30] Q&A Session Summary Question: Opportunities for OUS growth - Management noted that while 2022 may not see significant contributions from OUS markets, there is potential for growth in EMEA and China, with ongoing efforts to secure market share [50][52] Question: Commercial collaborations for IFC - Management discussed partnerships with OneBlood and Blood Centers of America to facilitate the nationwide launch of IFC, emphasizing the importance of these collaborations for market penetration [54][58] Question: Drivers for IFC adoption - Management highlighted the importance of real-world experience data and clinical studies in driving demand for IFC, with expectations for significant impact from upcoming data releases [62] Question: SG&A trends and capital allocation - Management indicated that SG&A expenses may increase slightly but at a slower pace than revenue growth, with a focus on leveraging existing commercial infrastructure to address TAM expansion [66][68]

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].

Financial Data and Key Metrics Changes - The company reported Q1 2021 product revenue of $23.4 million, a 26% increase from $18.6 million in Q1 2020 [25] - Gross margins for Q1 were 52.5%, down from 55.3% in the prior year, reflecting a 280 basis point decline due to a shift in product mix [28][29] - The net loss for Q1 was $17.5 million, compared to $16.5 million in the same period last year [32] Business Line Data and Key Metrics Changes - INTERCEPT platelet kits demand in North America grew 51% year-over-year, with sales to the top 5 blood centers increasing 59% [18] - Kit sales represented 95% of Q1 product sales, with platelet kits accounting for approximately 90% and plasma kits for 10% [26] - Government contract revenue totaled $6.2 million in Q1, slightly up from $6 million in Q1 2020 [27] Market Data and Key Metrics Changes - In the EMEA region, product revenue increased 9% year-over-year, driven by major customers in established markets [20] - The company anticipates continued growth in international markets, particularly in Asia Pacific and Latin America [13] Company Strategy and Development Direction - The company raised its 2021 product revenue guidance to a range of $110 million to $114 million, reflecting a year-over-year growth of 20% to 24% [11][35] - The company is focusing on expanding its market presence and product offerings, including the anticipated launch of INTERCEPT Fibrinogen Complex [41] - The total addressable market for INTERCEPT products is estimated at $7 billion, with significant opportunities in geographies where products are not yet approved [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of hospital adoption and the potential for continued revenue growth throughout the year [41] - The company is preparing for a nationwide launch of INTERCEPT Fibrinogen Complex, with positive market reception anticipated [41] - Management highlighted the importance of the upcoming FDA compliance deadline as a driver for increased production capabilities among blood centers [46] Other Important Information - The company is working on a clinical trial for INTERCEPT plasma in burn injury treatment, showcasing its potential applications [39] - The company is in discussions with additional production partners to enhance capacity and expedite market entry in various regions [23] Q&A Session Summary Question: What is driving the improved guidance? - The guidance revision is primarily driven by strong performance in the U.S. market, with increasing confidence in production capabilities and hospital access as the COVID pandemic subsides [44][46] Question: Is the pricing for the cryoprecipitate fibrinogen complex included in the TAM calculations? - The proposed pricing of $3,900 per patient is included in the total addressable market calculations for the product [48][50] Question: Can you provide more details on U.S. platelet adoption? - There is accelerated adoption among blood centers, with some moving faster than anticipated, driven by increased awareness of safety needs due to the pandemic [58][62] Question: What is the timeline for the cryo product launch? - The BLA submissions are expected to occur mid-year, with a nationwide rollout anticipated in mid-2022 [75] Question: How are partnerships in LATAM and China progressing? - The company is securing tenders in Brazil, but COVID-19 has posed challenges for further penetration in Latin America [78]

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, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 19 ...

Cerus Corporation (NASDAQ:CERS) Q4 2020 Results Earnings Conference Call February 25, 2021 4:30 PM ET Company Participants Matt Notarianni - Senior Director, Investor Relations Obi Greenman - President and CEO Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Carol Moore - Senior Vice President, Regulatory Affairs and Quality Conference Call Participants Nathan Leiphardt - Stephens, Inc. Matthew Blackman - Stifel Brandon Folkes - Cantor Fitzgerald Operator Ladies and gentlemen, ...

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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Preferred Share Purchase Rights (Title of Class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Ye ...