Cerus Corporation (NASDAQ:CERS) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Jessica Hanover – Vice President-Corporate Affairs Obi Greenman – President and Chief Executive Officer Vivek Jayaraman – Chief Operating Officer Kevin Green – Chief Financial Officer Conference Call Participants Brandon Folkes – Cantor Fitzgerald Matt Blackman – Stifel Operator Good day, and welcome to the Cerus Corporation’s First Quarter 2023 Earnings Conference Call. At this time all participant ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (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, 2023 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 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Common Stock, pa ...

Cerus Corp (NASDAQ:CERS) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Joel Trujillo - Senior Director, IR William Greenman - President, CEO & Director Vivek Jayaraman - COO Kevin Green - VP, Finance & CFO Carol Moore - SVP, Regulatory Affairs, Quality & Clinical Conference Call Participants Mathew Blackman - Stifel, Nicolaus & Company Jacob Johnson - Stephens Inc. Brandon Folkes - Cantor Fitzgerald Joshua Jennings - Cowen and Company Operator Good day, ladies and gentle ...

60 See Note 7, Debt, in Part IV, Item 15, "Exhibits and Financial Statement Schedules" of this Annual Report on Form 10-K for more information on the debt under our Term Loan Credit Agreement and the Revolving Loan Credit Agreement. Critical Accounting Policies and Management Estimates Results of Operations Cost of Product Revenue Research and Development Expenses uncertainties associated with the successful completion of our research and development projects, which risks and uncertainties are discussed in ...

Cerus Corporation (NASDAQ:CERS) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Jessica Hanover - Vice President, Corporate Affairs Obi Greenman - President and Chief Executive Officer Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Conference Call Participants Mathew Blackman - Stifel Brandon Folkes - Cantor Fitzgerald Operator Good day and thank you for standing by. Welcome to the Cerus Corporation’s Quarter Three 2022 Earnings Conference C ...

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 September 30, 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 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) ...

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 | --- | --- | --- | |--------------------------------------------------------------------------------------|----------- ...