Regulatory Approvals and Product Development - The INTERCEPT Blood System has received regulatory approvals and is marketed in multiple regions, including the U.S., Europe, and Latin America[102]. - The red blood cell system is still in development and has not been commercialized, with a CE application closed due to insufficient data[105]. - The company plans to initiate a modular PMA application for the red blood cell system upon completion of the RedeS clinical trial, previously expected in the second half of 2026[105]. - The company has agreements with BARDA for funding to support the development of the red blood cell system, with the initial agreement expiring in September 2026 and a new agreement expiring in September 2030[106]. - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020, with ongoing efforts to support blood centers in obtaining necessary licenses[107]. - The company is assessing strategies for a potential new MDR application for the red blood cell system following the closure of the previous application[105]. - The ReCePI study demonstrated non-inferiority of INTERCEPT RBCs compared to conventional RBCs, meeting its primary efficacy endpoint[105]. Financial Performance - Product revenue for the three months ended September 30, 2024, increased by 16% to $46,017,000 compared to $39,772,000 in the same period of 2023, driven by sales volume growth in disposable platelet kit sales to U.S. customers[123]. - Government contract revenue for the three months ended September 30, 2024, decreased by 38% to $4,639,000 compared to $7,479,000 in the same period of 2023, primarily due to a decrease in revenue from BARDA[123]. - Total revenue for the three months ended September 30, 2024, increased by 7% to $50,656,000 compared to $47,251,000 in the same period of 2023[123]. - The company expects product revenue for INTERCEPT disposable kits to increase in future periods due to growth in the global platelet business and increased market acceptance of the INTERCEPT Blood System[123]. Funding and Capital Requirements - As of September 30, 2024, BARDA has committed to reimburse certain expenses related to the clinical development of the red blood cell system, with a total funding opportunity of up to $188.4 million under the 2024 BARDA Agreement[117]. - The 2024 BARDA Agreement includes a base period with committed funding of up to $32.1 million and subsequent option periods that could increase total funding[117]. - The company may need to curtail planned development or commercialization activities if unable to raise additional capital due to volatile global financial markets[110]. - The company anticipates that government contract revenue will increase in future periods as multiple contracts are active and activities supporting those contracts ramp up[123]. - The company expects to continue seeking access to equity capital markets to support development efforts, which may lead to substantial dilution for existing shareholders[148]. - The company’s near-term capital requirements are heavily reliant on successful commercialization of the INTERCEPT Blood System and ongoing studies, with potential funding from government contracts and equity markets[145]. - The company faces risks related to BARDA funding, which is subject to various uncertainties, including the ability to meet required milestones and potential budget cuts[150]. Expenses and Cash Flow - Cost of product revenue increased by 10% to $19,818,000 for the three months ended September 30, 2024, compared to $17,956,000 for the same period in 2023[124]. - Gross margin on product sales improved to 57% for the three months ended September 30, 2024, up from 55% in the same period of 2023[125]. - Research and development expenses decreased by 17% to $14,013,000 for the three months ended September 30, 2024, compared to $16,783,000 for the same period in 2023[128]. - Selling, general and administrative expenses increased by 10% to $17,786,000 for the three months ended September 30, 2024, compared to $16,155,000 for the same period in 2023[132]. - Total cash and cash equivalents as of September 30, 2024, were $21,575,000, an increase from $11,647,000 as of December 31, 2023[140]. - Total debt increased to $83,368,000 as of September 30, 2024, compared to $79,796,000 as of December 31, 2023[141]. - Net cash provided by operating activities was $6,430,000 for the nine months ended September 30, 2024, compared to net cash used of $27,985,000 during the same period in 2023[142]. - The company expects to incur additional research and development costs due to inflationary pressures and potential regulatory approvals in new geographies[129]. - The restructuring plan initiated in June 2023 resulted in a reduction in force, with restructuring charges of $1,600,000 recorded in the three months ended September 30, 2023[133]. - Foreign exchange losses were reported during the three and nine months ended September 30, 2024, compared to gains in the same periods of 2023, primarily due to variations between the Euro and the U.S. dollar[135]. - Net cash used in investing activities for the nine months ended September 30, 2024, was lower compared to net cash provided during the same period in 2023, primarily due to decreased net proceeds from investments[143]. - Net cash provided by financing activities decreased to $4,218,000 for the nine months ended September 30, 2024, down from $9,490,000 in the same period in 2023, mainly due to payments related to the Revolving Loan Credit Agreement[144]. - Working capital increased to $87,008,000 as of September 30, 2024, compared to $78,392,000 as of December 31, 2023, driven by increased product sales and collections[144]. - The company may experience substantial dilution if additional capital is raised by issuing equity securities[109]. - The principal amounts outstanding under the Term Loan Credit Agreement will begin amortizing by April 1, 2026, which could negatively impact available working capital[109]. - The company has not recorded any credit losses during the three and nine months ended September 30, 2024, and 2023, respectively[154]. - The company may need additional funds to complete development activities for the red blood cell system if costs exceed expectations or delays occur[152].

Financial Data and Key Metrics Changes - The company reported product revenue of $46 million for Q3 2024, representing a year-over-year growth of 16% [28] - For the first nine months of 2024, product revenue reached $129.5 million, up 18% from the prior year [29] - The net loss attributable to the company narrowed by 60% to $2.9 million for Q3 2024, compared to $7.3 million in the prior year [39] - Non-GAAP adjusted EBITDA for Q3 2024 was positive at $4.4 million, compared to a loss of nearly $1 million for the prior year [39] Business Line Data and Key Metrics Changes - North American platelet sales were the major contributor to product revenue growth during the quarter [29] - The U.S. platelet business saw product revenues exceed prior year levels by 17% [30] - ISC product revenue increased to $2.3 million in Q3 2024, up from $1.7 million in the prior year [31] Market Data and Key Metrics Changes - EMEA product revenues were stable to slightly higher compared to the prior year and the second quarter of 2024 [30] - FX rates provided a slight tailwind for the EMEA business, benefiting the top-line results by approximately 40 basis points [30] Company Strategy and Development Direction - The company is raising its full-year 2024 product revenue guidance to a range of $177 to $179 million, up from the previous range of $175 to $178 million [43] - The company is focused on expanding its manufacturing capacity to meet growing demand for IFC products [48] - The company is collaborating with BARDA to fund further development and regulatory activities for INTERCEPT RBCs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive outlook for the full year 2024, driven by strong commercial performance [9] - The company noted the ongoing need for pathogen inactivation due to rising incidences of emerging viruses [13] - Management highlighted the importance of customer confidence in the INTERCEPT technology as a key driver for growth [46] Other Important Information - The company ended Q3 2024 with a cash position of $75.6 million [41] - Operating cash flows for Q3 were positive at $4.1 million, compared to cash used for operations of $10.5 million during the same period in 2023 [42] Q&A Session Summary Question: Anticipation of additional manufacturing capacity for IFC - Management indicated that they are working with blood centers to add manufacturers for IFC and anticipate continued growth in supply as demand increases [48][49] Question: Timeline for LED illuminator approval - The company is targeting a launch for the LED illuminator in Europe in 2025, with a PMA submission in the U.S. likely in 2026 [51] Question: Growth drivers for IFC - Growth is coming from both new customer acquisition and deeper penetration within existing accounts, with approximately 55-60% of customers added this year being new [56] Question: Sustainability of cash flow - Management noted that they expect to generate operating cash flows due to growth in the top line and effective management of margins and operating expenses [90] Question: Government contract revenue expectations - The company expects government contract revenue to increase in 2025 as new BARDA contract activities ramp up alongside ongoing initiatives [84]

Company Performance - Cerus reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, and an improvement from a loss of $0.03 per share a year ago, representing an earnings surprise of 33.33% [1] - The company posted revenues of $46.02 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 4.35% and up from $39.77 million in the same quarter last year [2] - Over the last four quarters, Cerus has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - Cerus shares have declined approximately 21.3% since the beginning of the year, contrasting with the S&P 500's gain of 22.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $49.2 million, and for the current fiscal year, it is -$0.13 on revenues of $176.7 million [7] Industry Context - The Medical - Products industry, to which Cerus belongs, is currently ranked in the top 25% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Cerus's stock performance [5]

Revenue Performance - Product revenue for Q3 2024 was $46.0 million, a 16% increase from $39.8 million in Q3 2023[4] - Total revenue for the first nine months of 2024 was $144.6 million, an 8% increase from $133.5 million in the same period of 2023[2] - The company raised its full-year 2024 product revenue guidance to a range of $177 million to $179 million[15] - Government contract revenue for Q3 2024 was $4.6 million, a 38% decrease from $7.5 million in Q3 2023[5] - Total product revenue for Q3 2024 was $46.017 million, a 16% increase from $39.772 million in Q3 2023[29] - Nine-month product revenue for 2024 reached $129.461 million, up 18% from $109.599 million in the same period of 2023[30] - North America generated $31.514 million in revenue for Q3 2024, a 21% increase from $25.983 million in Q3 2023[29] Profitability and Loss - Product gross profit for Q3 2024 was $26.2 million, a 20% increase from the prior year, with a gross margin of 56.9%[6] - Gross profit on product revenue for Q3 2024 was $26.199 million, compared to $21.816 million in Q3 2023, reflecting a significant improvement[30] - Net loss attributable to Cerus Corporation for Q3 2024 was $2.9 million, significantly improved from a loss of $7.3 million in Q3 2023[11] - The net loss attributable to Cerus Corporation for Q3 2024 was $(2.934) million, an improvement from $(7.267) million in Q3 2023[30] - The company reported a net loss per share of $(0.02) for Q3 2024, compared to $(0.04) for Q3 2023[30] - Non-GAAP adjusted EBITDA for Q3 2024 was a positive $4.4 million, compared to a loss of $1.0 million in Q3 2023[12] - The company anticipates a non-GAAP adjusted EBITDA for 2024, but has not provided a reconciliation to projected GAAP net loss due to variability in certain components[26] - The company reported a loss from operations of $961,000 for the three months ended September 2024, compared to a loss of $5,243,000 for the same period in 2023, indicating a significant improvement[32] Operating Expenses - Operating expenses for Q3 2024 decreased by 8% to $31.8 million compared to $34.5 million in Q3 2023[7] - Operating expenses for research and development in Q3 2024 were $14.013 million, down from $16.783 million in Q3 2023[30] - Share-based compensation for the three months ended September 2024 was $5,830,000, up from $3,979,000 for the same period in 2023, an increase of about 46%[32] Cash Flow and Assets - The company generated positive cash flows of $4.1 million from operations in Q3 2024, compared to cash used in operations of $10.5 million in the prior year[14] - Cash and cash equivalents increased significantly from $11,647,000 in December 2023 to $21,575,000 in September 2024, representing an increase of about 85%[31] - Total current assets decreased from $144,441,000 in December 2023 to $140,612,000 in September 2024, a decline of approximately 2%[31] Liabilities - Total liabilities decreased from $144,304,000 in December 2023 to $135,258,000 in September 2024, a reduction of approximately 6%[31] - Current liabilities decreased from $67,521,000 in December 2023 to $54,345,000 in September 2024, a decline of about 19%[31] - Non-current inventories decreased from $19,501,000 in December 2023 to $14,811,000 in September 2024, a decrease of approximately 24%[31] - Operating lease liabilities – current decreased from $2,452,000 in December 2023 to $2,260,000 in September 2024, a decline of approximately 8%[31] Manufacturing and Supply Chain - Cerus expanded U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex following new BLA approvals, addressing growing demand[3] - Cerus is reliant on third-party suppliers for manufacturing and distribution, which poses additional risks to its supply chain[24] - The company faces risks related to regulatory approvals and market acceptance of the INTERCEPT Blood System, which could impact future revenues[24]

Financial Data and Key Metrics Changes - The company reported product revenue of $45.1 million for Q2 2024, representing a year-over-year growth of 16% and bringing the first half revenue to $83.4 million, up 20% from the first half of last year [18][19] - The net loss attributable to the company for Q2 narrowed by 56% to $5.8 million or $0.03 per diluted share, compared to $13.3 million or $0.07 per diluted share for the prior year period [23] - Non-GAAP adjusted EBITDA for Q2 2024 generated positive adjusted EBITDA of just under $1 million, compared to a loss of $4.7 million for the prior year period [23] Business Line Data and Key Metrics Changes - North American platelet sales were the major contributor to product revenue growth, with U.S. second quarter 2024 product revenues exceeding prior year levels by 19% [19] - INTERCEPT Fibrinogen Complex (IFC) product revenue was $2 million, up from $1.4 million in the prior year period, driven by new hospital users and increased adoption [19][15] - The company expects annual IFC revenue guidance to remain in the range of $8 million to $10 million [25] Market Data and Key Metrics Changes - Canadian Blood Services completed the implementation of INTERCEPT across its entire platelet production operation, achieving 100% pathogen inactivation [13] - The international business showed solid growth, particularly in regions like the Middle East, Latin America, and Asia-Pacific, with ongoing validation efforts in Canada and Hema-Quebec [14][19] Company Strategy and Development Direction - The company raised its annual product revenue guidance range for the full year to $175 million to $178 million, up from the previous range of $172 million to $175 million, reflecting confidence in growth [6][25] - The company is focused on expanding the INTERCEPT blood system and advancing the IFC business, with plans for new product approvals and geographic expansion [26][27] - The introduction of the new LED illuminator is expected to enhance operational efficiency and customer satisfaction, with a regulatory submission planned for later this year [9][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting and exceeding product revenue expectations, citing the growing number of blood centers and hospitals using INTERCEPT [6] - The management highlighted the importance of pathogen inactivation in blood safety strategies, especially in light of rising health threats like dengue [7] - The company aims to achieve adjusted EBITDA breakeven for the full year 2024, with a focus on improving bottom-line results and managing working capital [10][25] Other Important Information - The company ended Q2 with a cash position of $71.2 million, with a positive operating cash flow of $0.4 million for the quarter, compared to cash used from operations of $7.6 million during the prior year period [24] - The company is not currently forecasting any rebuild of customer-level inventory as a driver of revenue upside, focusing instead on sustained growth from INTERCEPT adoption [48] Q&A Session Summary Question: Inventory rebuilding following extended shelf life - Management anticipates filing for an 18-month shelf life later this year, but did not see significant rebuilding of inventories in Q2 [29] Question: Status of Hema-Quebec validation process - Hema-Quebec's validation is effectively complete, with initial pathogen reduction expected in 2025 and full implementation in 2026 [30] Question: Outlook for IFC growth and capacity constraints - There is significant opportunity for growth both from existing customers and new hospital acquisitions, with sufficient production capacity expected to support growth [34][36] Question: Roadmap for IFC growth in 2025 - While not providing formal guidance for 2025, management indicated that IFC could represent 10% of total sales, with significant growth potential [38][40] Question: Update on INTERCEPT red blood cell program in the EU - The company is awaiting feedback from the competent authority in the Netherlands, with expectations for a response after the summer holidays [44] Question: Sources of upside to the 2024 guidance - Management does not anticipate inventory rebuilds as a revenue driver, but sees growth from increased hospital demand and IFC adoption [46][48] Question: Features and improvements of the next-gen illuminator - The new illuminator is designed to be more space-efficient and user-friendly, with a regulatory submission expected soon [49][50] Question: Update on international opportunities - The company is making progress in China and the Middle East, with strong growth potential in these regions [55][57]

Financial Performance - Cerus reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.04, and improved from a loss of $0.07 per share a year ago, representing an earnings surprise of 25% [1] - The company posted revenues of $45.08 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 6.07%, compared to year-ago revenues of $38.85 million [2] - Over the last four quarters, Cerus has exceeded consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance and Outlook - Cerus shares have increased by approximately 4.6% since the beginning of the year, while the S&P 500 has gained 15.8% [3] - The company's earnings outlook will be crucial for future stock movements, with current consensus EPS estimates at -$0.02 on $43.7 million in revenues for the coming quarter and -$0.10 on $174 million in revenues for the current fiscal year [4][7] Industry Context - The Medical - Products industry, to which Cerus belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Cerus may also be influenced by the overall industry outlook, as empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions [5][8]

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 June 30, 2024 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 (Exact name of registrant as specified in its charter) Delaware 68-0262011 (State or other jurisdiction ...

Exhibit 99.1 Cerus Corporation Announces Second Quarter 2024 Financial Results and Increases Full-Year 2024 Product Revenue Guidance Range First Half of 2024 Product Revenue Increased 20% from Prior Year Period Increasing Full-Year 2024 Product Revenue Guidance Range from $172-175 Million to $175-178 Million CONCORD, CA, August 1, 2024 - Cerus Corporation (Nasdaq: CERS) today announced financial results for its second quarter and six months ended June 30, 2024. Total revenue for the three and six months end ...

Financial Data and Key Metrics Changes - The company reported product revenue of $38.4 million for Q1 2024, representing a year-over-year growth of 24% [29] - Operating expenses for Q1 2024 totaled $34.3 million, a decrease of 12% from $38.9 million in the prior year [32] - The net loss attributable to the company narrowed by 38% to $9.7 million or $0.05 per diluted share compared to $15.6 million or $0.09 per diluted share for the prior year [55] Business Line Data and Key Metrics Changes - The U.S. INTERCEPT Fibrinogen Complex (IFC) generated revenue of $1.9 million in Q1, driven by national sales agreements with large U.S. blood center partners [53] - North American platelet sales were the major contributor to product revenue growth, exceeding prior year levels by more than 40% [29] - EMEA product revenues decreased by 9% year-over-year, primarily due to delays in order fulfillment [30] Market Data and Key Metrics Changes - The Canadian market is nearing full implementation of INTERCEPT platelets, with nearly 100% adoption across Canadian Blood Services [52] - The Gulf region is identified as a targeted growth area due to increased healthcare investments and a focus on blood safety [49] - The company expects growth in EMEA and the U.S. following the resolution of timing issues related to order patterns [64] Company Strategy and Development Direction - The company is committed to achieving adjusted EBITDA breakeven for the full year 2024 [23] - The growth strategy includes expanding the INTERCEPT platelet business in North America and Europe, as well as increasing uptake of IFC in the U.S. [34] - The company is actively working to increase manufacturing capacity to meet anticipated demand [91] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism for continued growth in the top line and stable gross margins [8] - The company is increasingly confident in its growth expectations for 2024, reiterating product revenue guidance of $172 million to $175 million [34] - Management noted that the extended shelf life of products is expected to relieve supply chain pressure and mitigate risks of product obsolescence [25] Other Important Information - The company generated positive operating cash flows of $2 million for Q1 2024, compared to cash used from operations of $8.5 million in the prior year [81] - The company is awaiting feedback from the Netherlands competent authority regarding regulatory questions [3] Q&A Session Summary Question: What is the status of reimbursement for IFC? - Management confirmed that reimbursement for IFC is linked to the NTAP and is optimistic about its evolution [93] Question: Can you provide more details on the international business weakness? - Management clarified that the decline in EMEA was primarily due to timing issues rather than fundamental weaknesses, expecting a rebound [64] Question: What is the update on regulatory progress in China? - The company is awaiting additional questions from the NPA and expects to provide clarity on timing for approval in the second quarter [65] Question: Are expectations for guidance trending towards the higher end? - Management indicated increased confidence in guidance but emphasized the need to see Q2 results before making definitive statements [67][68] Question: What are the trends in IFC growth with blood centers? - Management noted a material increase in orders from blood centers directly distributing IFC, validating the strength of that channel [90]

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, 2024 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 (Exact name of registrant as specified in its charter) Delaware 68-0262011 (State or other jurisdiction ...