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]

Product Development and Regulatory Approval - The INTERCEPT Blood System is designed to reduce blood-borne pathogens in donated blood components, including platelets, plasma, and red blood cells, and has received FDA approval and CE Mark in various regions [16]. - The red blood cell system is in Phase 3 clinical trials in the U.S., with two studies assessing safety and efficacy compared to conventional red blood cells [17]. - The company completed a European Phase 3 clinical trial for acute anemia, meeting its primary endpoint with INTERCEPT-treated RBCs showing a mean hemoglobin content of 53.1g [29]. - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020 and is being marketed to blood centers and hospitals [25]. - The CE Mark application for the red blood cell system was resubmitted in June 2021, but approval is not expected for at least another 12 months [19]. - The company anticipates increasing research and development expenses related to the licensure of the red blood cell system, including ongoing clinical studies and regulatory submissions [78]. - The company is required to conduct post-approval studies for the platelet system, including a recovery study, to maintain FDA approval [85]. - The company must obtain FDA approval for any significant modifications to its platelet and plasma systems, which could delay or prevent marketing of modified systems [88]. - The company has detected two S-303 antibody events without evidence of hemolysis in the RedeS study and three similar events in the ReCePI study [189]. - The company may need to conduct additional Phase 3 clinical trials to demonstrate non-inferiority of INTERCEPT red blood cells compared to conventional red blood cells, which could further delay regulatory approvals [190]. - Regulatory compliance is complex and has become more stringent, potentially limiting operational expansion and increasing costs [206]. Clinical Trials and Studies - The company successfully completed a Phase 2 recovery and lifespan study and initiated a double-blind Phase 3 clinical study, known as the RedeS study, to assess INTERCEPT-treated RBCs against conventional RBCs in regions affected by the Zika virus [30]. - The RedeS study has been expanded to include up to 800 subjects, with a primary endpoint of hemoglobin increment following transfusion, and will support chronic use assessment for FDA approval [30]. - The ReCePI study, designed to evaluate INTERCEPT-treated RBCs for acute blood loss during surgery, is expected to enroll up to 600 subjects across 19 sites in the U.S. [30]. - Both RedeS and ReCePI trials have faced significant delays in subject recruitment due to COVID-19, impacting the timely completion of clinical trials [30]. - The company has experienced delays in clinical trials due to various factors, including the COVID-19 pandemic and difficulties in patient enrollment [177]. Financial Performance and Market Adoption - The company anticipates significant operating losses due to high research, development, and regulatory compliance costs, which may hinder profitability [20]. - Budget constraints in healthcare facilities may limit the adoption of INTERCEPT products, especially in the context of COVID-19-related financial pressures [57]. - The company relies heavily on the commercial success of the INTERCEPT Blood System, and any inability to successfully commercialize it in the U.S. could adversely affect financial performance [125]. - The ongoing pandemic has disrupted supply chains and may impact the ability to meet increased demand for products, affecting sales and operating results [120]. - The INTERCEPT Blood System's market adoption in the U.S. is uncertain, with potential customers needing to comply with the FDA's Final Guidance Document, which may lead them to choose competing products if INTERCEPT is not successfully commercialized [127]. Manufacturing and Supply Chain - The company relies on Fresenius Kabi AG for the manufacture of disposable kits, with an agreement extending through July 1, 2025, and pricing adjustments based on a price index starting in 2022 [41]. - The company is actively seeking alternative manufacturers for several components, as it currently does not have alternate suppliers for many critical components [41]. - The manufacturing facility for platelet and plasma systems was recently audited by the FDA, with no objectionable conditions observed, but compliance with audit findings may incur additional costs [89]. - The complexity of manufacturing products increases the risk of supply chain disruptions if suppliers fail to meet FDA standards [208]. Competitive Landscape - The company faces competition in the U.S. from Octapharma AG and other diagnostic companies approved for pathogen detection in donated blood products [68]. - The company may face significant competition from other pathogen reduction technologies, which could reduce market opportunities and impact sales [166]. - The consolidation of the U.S. blood banking market may further concentrate the customer base, impacting potential sales [49]. Regulatory Challenges - The company must comply with various data privacy laws, including the GDPR and CCPA, which may impose additional operational requirements [99]. - Regulatory authorities may impose sanctions or require product withdrawals if compliance issues arise, which could harm the company's business [201]. - The EU's MDR has introduced stricter requirements for clinical evidence and premarket assessment, which may lead to substantial costs for the company [90]. - The company must address operational and technical problems that customers may experience with the INTERCEPT Blood System to avoid reduced market acceptance [138]. Workforce and Corporate Governance - As of December 31, 2021, the company had 294 employees, with approximately 82% being women and 45% of U.S. employees identifying as non-white [103]. - The voluntary employee turnover rate was 9.4%, indicating a stable workforce [104]. - The company is in the process of designing and implementing a corporate Environmental, Social and Governance (ESG) program, with expectations to report progress annually starting in 2023 [105]. - The company is committed to fostering a diverse and inclusive workforce, recognizing it as a key factor for long-term success [106].

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].

Financial Data and Key Metrics Changes - The company reported record product revenue of $31.5 million for Q2 2021, a 46% increase from $21.5 million in Q2 2020, marking the largest product revenue quarter in the company's history [18] - Product revenue guidance for 2021 has been raised to $118 to $122 million, up from the previous guidance of $110 to $114 million, reflecting a growth of 28% to 33% compared to 2020 [26] - The net loss for Q2 2021 was $15.4 million, or $0.09 per diluted share, compared to a net loss of $14.9 million, also $0.09 per diluted share, in the prior year [24] Business Line Data and Key Metrics Changes - Product sales for INTERCEPT platelet kits accounted for approximately 91% of total kit sales in Q2 2021, with kit sales representing 97% of total product sales [18] - The calculated number of treatable platelet doses increased by 67% year over year [18] - The INTERCEPT Fibrinogen Complex (IFC) product is expected to ramp up delivery to early adopters in the second half of 2021, with several hospital contracts already signed [11] Market Data and Key Metrics Changes - North American sales increased by 128% year over year, driven by robust demand for platelet kits, with sales to the top five blood centers growing by 150% [19] - EMEA region sales grew by 12% year over year, with strong demand from larger accounts [20] - Government contract revenue totaled $6.3 million in Q2 2021, up from $5.3 million in Q2 2020, with expectations for further increases in the second half of 2021 [20] Company Strategy and Development Direction - The company aims to make INTERCEPT the new standard of care for platelet safety in the US, with a focus on increasing production capacity and improving supply chain continuity [10] - The company is also targeting a nationwide launch of IFC in the second half of 2022, following the receipt of necessary approvals [12] - The company is committed to addressing the blood shortage in the US by increasing the availability of platelets and plasma through its INTERCEPT technology [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth through the second half of 2021 and into 2022, driven by the rapid adoption of INTERCEPT technology [8] - The company believes that the INTERCEPT platform can help alleviate blood shortages and improve donor eligibility [14] - Management anticipates that hospitals will continue to prefer pathogen-reduced platelets, which will support pricing flexibility for INTERCEPT products [40] Other Important Information - The company ended Q2 2021 with approximately $122.8 million in cash, cash equivalents, and short-term investments [24] - Cash used from operations improved to $8.7 million in Q2 2021, down from $18 million in Q1 2021 [25] - The company has received a positive final decision from CMS for the new technology Add-On Payment for IFC, effective October 1 [12] Q&A Session Summary Question: What is the expected growth trajectory for the second half of the year? - Management indicated that Q4 is expected to be stronger than Q3, driven by US customers preparing for the compliance deadline on October 1 [33] Question: How is the company addressing the pricing for INTERCEPT products? - Management noted that blood centers are benefiting from pricing flexibility due to the value provided by pathogen-reduced platelets, which has been accepted at the hospital level [40][43] Question: What is the status of the Canadian Blood Services collaboration? - The Canadian market for platelets is significant, and the company is working closely with Canadian Blood Services to achieve full adoption of INTERCEPT technology [66] Question: What are the expectations for the US platelet market outside of the top five blood centers? - Management reported strong growth across all blood centers in the US, with increasing adoption of INTERCEPT technology [49] Question: What is the timeline for the rollout of red blood cells in Europe? - The planned rollout for red blood cells in Europe is expected in the second half of 2022, pending review by the competent authority and notified body [53]

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]

Regulatory Approvals - The INTERCEPT Blood System has received FDA approval for Cryoprecipitation, which is intended for the treatment of massive hemorrhage associated with fibrinogen deficiency [122]. - The platelet system is approved in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components, reducing the risk of transfusion-transmitted infection [118]. - The company is currently developing the red blood cell system, which has not yet been commercialized, with CE Mark approval expected in 2022 [119]. - The company has extended its agreement with BARDA through December 2021, providing funding for the development of the red blood cell system and related clinical programs [121]. - The BARDA agreement has committed up to $116.9 million for reimbursement of expenses related to the clinical development of the red blood cell system, with potential total funding reaching $213.9 million if additional option periods are exercised [134]. - The company has entered into a five-year agreement with the FDA for the development of next-generation compounds, with a total potential contract value of $11.1 million [135]. Financial Performance - Product revenue for the three months ended March 31, 2021, was $23.4 million, a 26% increase from $18.6 million in the same period in 2020, driven by sales volume growth in disposable platelet system kits in the U.S. and increased plasma system kit sales in Europe and the Middle East [142]. - Total revenue for the three months ended March 31, 2021, was $29.6 million, up 20% from $24.6 million in the same period in 2020 [142]. - Government contract revenue recognized during the three months ended March 31, 2021, was $6.2 million, compared to $6.0 million in the same period in 2020, reflecting ongoing activities under the BARDA agreement [143]. - Cost of product revenue increased by 33% to $11.1 million for the three months ended March 31, 2021, compared to $8.3 million in the same period in 2020, primarily due to increased sales and foreign exchange impacts [145]. - Gross margin on product sales decreased to 53% for the three months ended March 31, 2021, down from 55% in the same period in 2020, attributed to unfavorable product mix and currency exchange effects [147]. Operational Challenges - The company faces risks related to the COVID-19 pandemic, which may delay clinical trial enrollment and regulatory approvals [121]. - The company is actively monitoring the impacts of the COVID-19 pandemic on its operations, which may affect product revenues and clinical trials [139]. - The company expects to incur additional research and development costs for post-approval studies and regulatory approvals, but the costs are uncertain due to various risks including government regulations and the impact of the COVID-19 pandemic [151]. - The company may need to raise additional capital to support the development and regulatory approval of the red blood cell system [119]. - The company may need to obtain additional funds for the development of the red blood cell system for potential regulatory approval in Europe if costs exceed expectations or delays occur [175]. Sales and Marketing Strategy - The company plans to transition distribution of the INTERCEPT Blood System from third parties to a direct sales model in certain international markets [114]. - The company anticipates potential pricing pressures and competition for hospital business due to its strategy of selling INTERCEPT Blood System for Cryoprecipitation kits to strategic blood centers [122]. - The company plans to begin a limited launch of PRCFC to U.S. hospital customers within the year, anticipating increased product revenue from this initiative [142]. Financial Position - Cash and cash equivalents increased to $57,607 thousand as of March 31, 2021, from $36,594 thousand as of December 31, 2020 [162]. - Total debt increased to $64,554 thousand as of March 31, 2021, compared to $48,104 thousand as of December 31, 2020, with current debt at $9,938 thousand and non-current debt at $54,616 thousand [164]. - Working capital increased slightly to $126,508 thousand as of March 31, 2021, compared to $123,457 thousand as of December 31, 2020, mainly due to borrowing under the Term Loan Credit Agreement [167]. Expenses - Research and development expenses remained relatively flat at $15,748 thousand for the three months ended March 31, 2021, compared to $15,810 thousand for the same period in 2020, reflecting a change of (62) thousand or (0%) [150]. - Selling, general, and administrative expenses increased by 20% to $19,170 thousand for the three months ended March 31, 2021, up from $15,913 thousand in the same period in 2020, primarily due to stock-based compensation and investments for the commercial launch of PRCFC [153]. - Total non-operating expense, net decreased by 9% to $(912) thousand for the three months ended March 31, 2021, compared to $(1,007) thousand for the same period in 2020 [156]. - Foreign exchange loss increased by 78% to $(396) thousand for the three months ended March 31, 2021, compared to $(223) thousand for the same period in 2020, primarily due to unfavorable foreign exchange variations [156]. Investment and Market Risk - The investment policy focuses on preserving principal and liquidity while maximizing returns on marketable securities to fund operations [178]. - Money market funds are classified as Level 1 in the fair value hierarchy, with a reasonable estimate of fair value due to their short maturity [178]. - Available-for-sale securities related to corporate debt and U.S. government agency securities are classified as Level 2 in the fair value hierarchy [178]. - No credit losses were recorded during the three months ended March 31, 2021 and 2020 [178]. - There were no material changes to market risk disclosures during the three months ended March 31, 2021 [180].

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 ...