Core Points - The World Health Organization (WHO) has updated its Essential Medicines List (EML) and the Essential Medicines List for Children (EMLc) to better align with international clinical guidelines for managing hemophilia and von Willebrand Disease (VWD) [1][2][3] - These revisions are expected to positively impact the lives of people with bleeding disorders (PWBDs) globally [1][4] Changes to EML and EMLc - New medicines added to the EML and EMLc include bi-specific monoclonal antibody emicizumab, recombinant FVIII and FIX clotting factor concentrates (CFCs), and desmopressin [7] - Plasma-derived FVIII and FIX CFCs were moved from the complementary to the core list, while both pathogen-reduced and non-pathogen reduced cryoprecipitate were removed as treatment options for hemophilia and VWD [7] - Factor IX Complex (prothrombin complex concentrate) was deleted as a therapeutic alternative to FIX CFCs [7] Impact and Collaboration - The updates to the WHO EML are seen as a significant advancement in ensuring access to modern and effective treatments for bleeding disorders [8][9] - The World Federation of Hemophilia (WFH) led a global effort involving various organizations and experts to advocate for these updates, highlighting the importance of collaboration in achieving this milestone [10][12]

Summary of Cirrus Corporation (CERS) Conference Call Company Overview - Cirrus Corporation is focused on transforming transfusion medicine, particularly through its Intercept blood systems, aiming to establish them as the global standard of care [3][6] - The company was founded in the early 1990s during the HIV and hepatitis epidemics, with a mission to safeguard blood components [6][7] Financial Performance - Reported a 16% year-over-year revenue growth, with updated guidance for total revenue between $200 million and $203 million [9][10] - The IFC product revenue guidance was increased to $16 million to $18 million, indicating significant growth potential [9][10] - The company burned $3 million in cash during the first half of the year but expects to generate positive operating cash flow for the full year [10][11] - Aiming for a second consecutive year of positive adjusted EBITDA, with confidence in achieving this based on current guidance [11] Product Insights Intercept FibroGen Complex (IFC) - IFC is a pathogen-reduced cryoprecipitate with a five-day shelf life, designed for immediate availability during major bleeding events [12][13] - The product addresses inefficiencies in traditional cryoprecipitate, which has longer preparation times and higher waste rates [13][14] - The total addressable market (TAM) for IFC is estimated at $300 million, indicating substantial growth opportunities [15] Platelet Business - The INTERCEPT product for platelets has seen over 20% annual growth rates due to FDA guidance on bacterial safety [21][22] - The U.S. market penetration is around 65-70%, with significant growth potential remaining [21][22] - In international markets, penetration varies significantly, with some countries fully adopting INTERCEPT while others lag behind [22][23] Red Blood Cells - Red blood cells account for approximately 70% of all transfusions globally, and the company is under regulatory review in Europe for its red blood cell product [32][33] - The company aims to capture 20% of the TAM for irradiated red cells upon approval, which would significantly enhance its market position [39][40] Regulatory and Market Strategy - The primary focus for commercialization is currently in the U.S., with plans to expand into international markets like the UK and Asia Pacific in the long term [17][19][20] - The company is navigating regulatory pathways in China and Japan, with ongoing discussions with local partners [29][30][31] Financial Strategy and Risks - The company has a term debt of $65 million, with plans to manage it through operational cash flows and potential refinancing [62][63] - The focus is on maintaining inventory levels to support growth while managing accounts receivable and payable effectively [63] Conclusion - Cirrus Corporation is positioned for significant growth in the transfusion medicine market, with innovative products and a strong financial outlook. The company is focused on expanding its market presence and achieving regulatory approvals to enhance its product offerings globally [65][66]

Financial Data and Key Metrics Changes - The company reported product revenue of $52.4 million for Q2 2025, representing a 16% year-over-year increase [22][28] - For the first half of 2025, product revenue increased 15% to $95.7 million compared to the same period in 2024 [22] - Non-GAAP adjusted EBITDA for Q2 2025 was $935,000, marking the fifth consecutive quarter of positive adjusted EBITDA [28] Business Line Data and Key Metrics Changes - IFC revenue for Q2 2025 was $5.6 million, up from $2 million in the prior year period, with strong demand driving growth [24] - The core platelet franchise continues to be a key revenue driver, with increasing adoption of pathogen-reduced platelets in the U.S. and international markets [9][14] - The INT-two 100 illuminator was launched, receiving positive feedback and contributing to product growth [10][15] Market Data and Key Metrics Changes - North American product revenues increased 17% year-over-year in Q2 2025, while EMEA product revenues rose 21% [23] - Canadian Blood Services transitioned to 100% routine use of INTERCEPT platelets, and growth was noted in the Middle East [15] - The company is addressing regulatory requirements in China to strengthen its market position [16][17] Company Strategy and Development Direction - The company aims to transform blood safety and availability through its INTERCEPT product portfolio, with a focus on expanding its market presence [6][31] - The anticipated regulatory approval of the INTERCEPT red blood cell program in Europe is expected to enhance customer relationships [32] - The company is committed to achieving positive non-GAAP adjusted EBITDA for the full year 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in exceeding the full-year 2025 product revenue guidance due to strong customer demand [7][31] - The company remains mindful of macroeconomic and geopolitical factors but believes its value proposition and pipeline position it well for future growth [20] - The strong commercial results and product development progress indicate a sustainable growth trajectory [20][31] Other Important Information - The company received a $7.2 million award from the U.S. Defense Department for a study evaluating the utility of early IFC in trauma patients [12] - The company ended Q2 2025 with $78 million in cash and equivalents, slightly down from $80.5 million in the prior year [29] Q&A Session Summary Question: Revenue guidance for the year and expected cadence - Management expects continued growth in the back half of the year, with a flattening from Q2 to Q3 due to seasonal factors and deferred revenue recognized in Q2 [35][36] Question: EU red blood cell opportunity and TAM - The expanded CE Mark submission allows access to all patient populations, reducing initial limitations and opening up new opportunities [37][38] Question: Key drivers for IFC guidance and quarterly cadence - The strong pipeline of new hospital customers and increased supply position are expected to drive growth, despite some backlog being cleared in the first half [42][44] Question: Operating expenses and investment growth - The increase in operating expenses is primarily due to government contract activity and cost of living adjustments, with no significant one-time expenses [45]

PART I FINANCIAL INFORMATION This section presents Cerus Corporation's unaudited condensed consolidated financial statements and detailed notes on accounting policies, financial instruments, and key agreements [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section details Cerus Corporation's unaudited condensed consolidated financial statements and comprehensive notes on accounting policies and financial instruments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%E2%80%93%20June%2030%2C%202025%20and%20December%2031%2C%202024) Total assets and liabilities increased from December 2024 to June 2025, driven by higher inventories and current debt, while equity slightly decreased Metric (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | **Assets** | | | | Total current assets | $168,534 | $152,022 | | Total assets | $213,071 | $200,917 | | **Liabilities** | | | | Total current liabilities | $84,358 | $63,608 | | Total liabilities | $156,901 | $144,021 | | **Equity** | | | | Total stockholders' equity | $55,428 | $56,145 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%E2%80%93%20Three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Product and government contract revenue increased for both periods ended June 30, 2025, leading to a narrowed net loss despite continued losses Metric (in thousands, except per share) | Metric (in thousands, except per share) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Product revenue | $52,445 | $45,079 | $95,684 | $83,444 | | Government contract revenue | $7,684 | $5,440 | $13,298 | $10,470 | | Gross profit on product revenue | $28,975 | $24,666 | $54,399 | $45,938 | | Research and development | $18,900 | $14,969 | $35,505 | $29,451 | | Selling, general and administrative | $21,182 | $18,973 | $41,468 | $38,772 | | Loss from operations | $(3,423) | $(3,836) | $(9,276) | $(11,815) | | Net loss attributable to Cerus Corporation | $(5,707) | $(5,775) | $(13,424) | $(15,463) | | Basic and diluted net loss per share | $(0.03) | $(0.03) | $(0.07) | $(0.08) | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20%E2%80%93%20Three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Comprehensive loss decreased for both periods ended June 30, 2025, due to a reduced net loss and changes in investment gains/losses Metric (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(5,715) | $(5,775) | $(13,433) | $(15,465) | | Foreign currency translation gain (loss) adjustment | $5 | $(3) | $8 | $(11) | | Unrealized (losses) gains on available-for-sale investments, net of taxes | $(12) | $258 | $119 | $418 | | Total comprehensive loss attributable to Cerus Corporation | $(5,714) | $(5,520) | $(13,297) | $(15,056) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%E2%80%93%20Three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Stockholders' equity remained stable, with increased paid-in capital from stock compensation offset by accumulated deficit from net losses Metric (in thousands) | Metric (in thousands) | December 31, 2024 | March 31, 2025 | June 30, 2025 | | :-------------------- | :---------------- | :------------- | :------------ | | Common Stock (Amount) | $186 | $191 | $191 | | Additional Paid-in Capital | $1,121,887 | $1,128,814 | $1,134,462 | | Accumulated Deficit | $(1,065,528) | $(1,073,242) | $(1,078,952) | | Total Stockholders' Equity | $56,896 | $56,242 | $56,170 | - Issuance of common stock from vesting of restricted stock units and ESPP purchases contributed to an increase in common stock and additional paid-in capital[16](index=16&type=chunk) - Stock-based compensation added **$6,635 thousand** for the three months ended March 31, 2025, and **$5,681 thousand** for the three months ended June 30, 2025, to additional paid-in capital[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%93%20Six%20months%20ended%20June%2030%2C%202025%20and%202024) Operating cash flow shifted to negative in 2025 due to inventory, while investing and financing activities provided less cash than in 2024 Metric (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Net cash (used in) provided by operating activities | $(3,290) | $2,360 | | Net cash used in investing activities | $(2,278) | $(5,661) | | Net cash provided by financing activities | $942 | $4,158 | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(4,230) | $751 | | Cash, cash equivalents, and restricted cash, end of period | $17,131 | $14,110 | - The shift in operating cash flow from positive to negative was primarily driven by increased inventory-related purchases and the timing of cash collections and payments in 2025[171](index=171&type=chunk) - The decrease in net cash from financing activities was mainly due to proceeds from the Term Loan Credit Agreement during the six months ended June 30, 2024, which did not recur in 2025[173](index=173&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, financial instruments, liabilities, debt, leases, equity, income taxes, and development agreements, including BARDA funding updates [Note 1. Summary of Significant Accounting Policies](index=9&type=section&id=Note%201.%20Summary%20of%20Significant%20Accounting%20Policies) This note details Cerus Corporation's accounting policies, covering revenue recognition, R&D, investments, inventories, stock-based compensation, and foreign currency - Revenue is recognized based on a five-step model, with product revenue from sales of INTERCEPT Blood System components and services, and government contract revenue recognized as costs are incurred or milestones are met[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) Product Revenue by Geographical Location (in thousands) | Region | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | North America | $35,286 | $30,097 | $65,886 | $55,195 | | Europe, Middle East and Africa | $16,612 | $13,725 | $28,824 | $26,439 | | Other | $547 | $1,257 | $974 | $1,810 | | Total product revenue | $52,445 | $45,079 | $95,684 | $83,444 | - The company consolidates its joint venture in China (Cerus Zhongbaokang (Shandong) Biomedical Co., LTD.) as a variable interest entity where it is the primary beneficiary[52](index=52&type=chunk) [Note 2. Available-for-sale Securities and Fair Value on Financial Instruments](index=19&type=section&id=Note%202.%20Available-for-sale%20Securities%20and%20Fair%20Value%20on%20Financial%20Instruments) Available-for-sale securities, primarily U.S. government and corporate debt, totaled $63.3 million, with no credit losses recognized Available-for-sale Securities (in thousands) | Category | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :-------------------------- | :----------------------- | :--------------------------- | | Money market funds | $1,269 | $1,773 | | United States government agency securities | $23,810 | $24,062 | | Corporate debt securities | $35,549 | $33,371 | | Mortgage-backed securities | $2,675 | $2,753 | | Total available-for-sale securities | $63,303 | $61,959 | Available-for-sale Securities by Contractual Maturity (in thousands) | Maturity | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :-------------------------- | :----------------------- | :--------------------------- | | One year or less | $45,734 | $38,173 | | Greater than one year and less than five years | $17,569 | $23,786 | | Total available-for-sale securities | $63,303 | $61,959 | - The company did not recognize any expected credit losses on its available-for-sale securities during the three and six months ended June 30, 2025 and 2024[67](index=67&type=chunk) [Note 3. Inventories](index=21&type=section&id=Note%203.%20Inventories) Total inventories increased to $68.9 million by June 2025, primarily due to a rise in finished goods Inventories (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Raw materials | $10,208 | $8,641 | | Work-in-process | $22,803 | $22,522 | | Finished goods | $35,867 | $21,132 | | Total inventories | $68,878 | $52,295 | | Less: non-current inventories | $14,349 | $14,145 | | Total current inventories | $54,529 | $38,150 | [Note 4. Accrued Liabilities](index=21&type=section&id=Note%204.%20Accrued%20Liabilities) Accrued liabilities rose to $20.9 million by June 2025, mainly from increased compensation and professional services Accrued Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued compensation and related costs | $12,628 | $11,939 | | Accrued professional services | $4,528 | $3,406 | | Other accrued expenses | $3,744 | $3,598 | | Total accrued liabilities | $20,900 | $18,943 | [Note 5. Debt](index=22&type=section&id=Note%205.%20Debt) Total debt increased to $84.9 million by June 2025, with a significant portion reclassified as current, under secured loan agreements Debt (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Term Loan | $64,891 | $64,862 | | Revolving Loan | $20,000 | $19,297 | | Total debt | $84,891 | $84,159 | | Less: current portion | $28,125 | $19,297 | | Non-current portion | $56,766 | $64,862 | Expected Principal, Interest and Fee Payments on Term Loan (in thousands) | Year ended December 31, | Principal | Interest and Fees | Total | | :---------------------- | :-------- | :---------------- | :---- | | 2025 | $0 | $3,725 | $3,725 | | 2026 | $24,375 | $6,499 | $30,874 | | 2027 | $32,500 | $2,939 | $35,439 | | 2028 | $8,125 | $1,456 | $9,581 | | Total | $65,000 | $14,619 | $79,619 | - The Term Loan Credit Agreement bears interest at a floating rate of Term SOFR (subject to a **1.00% floor**) plus **6.50%**, approximately **11.2%** at June 30, 2025[78](index=78&type=chunk) [Note 6. Leases](index=24&type=section&id=Note%206.%20Leases) Operating leases for facilities and equipment have a 4.1-year average term, with $1.972 million in expense for H1 2025 Operating Lease Information | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Weighted-average remaining lease term | 4.1 years | 4.8 years | | Weighted-average discount rate | 8.9% | 8.6% | Operating Lease Expense (in thousands) | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Operating lease expense | $1,007 | $1,000 | $1,972 | $1,964 | [Note 7. Commitments and Contingencies](index=26&type=section&id=Note%207.%20Commitments%20and%20Contingencies) Cerus had $26.0 million in short-term and $3.3 million in long-term purchase commitments for INTERCEPT Blood System components - Short-term purchase commitments totaled **$26.0 million** as of June 30, 2025[92](index=92&type=chunk) - Long-term purchase commitments totaled **$3.3 million** as of June 30, 2025[92](index=92&type=chunk) [Note 8. Stockholders' Equity](index=26&type=section&id=Note%208.%20Stockholders%27%20Equity) An Amended Sales Agreement allows for $96.8 million in common stock sales, with no activity in H1 2025 - The Amended Sales Agreement allows for the issuance and sale of up to **$96.8 million** of common stock[94](index=94&type=chunk) - No shares were sold under the Amended Sales Agreement during the six months ended June 30, 2025[95](index=95&type=chunk) - Approximately **$96.8 million** of common stock was available for sale under the Amended Sales Agreement as of June 30, 2025[95](index=95&type=chunk) [Note 9. Stock-Based Compensation](index=27&type=section&id=Note%209.%20Stock-Based%20Compensation) Cerus maintains ESPP and equity incentive plans, with 2.1 million shares available for ESPP and 14.6 million for the 2024 Plan Stock Options Activity (in thousands, except per share amounts) | Metric | Number of Options Outstanding | | :-------------------------- | :---------------------------- | | Balance at December 31, 2024 | 12,297 | | Forfeited/canceled | (1,713) | | Balance at June 30, 2025 | 10,584 | RSUs Activity (in thousands, except per share amounts) | Metric | Number of RSUs Unvested | | :-------------------------- | :---------------------- | | Balance at December 31, 2024 | 13,661 | | Granted | 10,830 | | Vested | (5,589) | | Forfeited | (738) | | Balance at June 30, 2025 | 18,164 | - As of June 30, 2025, approximately **14.6 million shares** were available for future issuance under the 2024 Plan[100](index=100&type=chunk) [Note 10. Income Taxes](index=29&type=section&id=Note%2010.%20Income%20Taxes) Income tax expense was $76 thousand (Q2) and $150 thousand (H1) from the European subsidiary, with a U.S. deferred tax valuation allowance Income Tax Expense (Benefit) (in thousands) | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Provision for (benefit from) income taxes | $76 | $(56) | $150 | $18 | - Income tax expenses were primarily related to the operating activities of the Cerus Europe B.V. subsidiary[103](index=103&type=chunk)[167](index=167&type=chunk) - A valuation allowance is maintained on substantially all U.S. net deferred tax assets due to a history of cumulative operating losses[168](index=168&type=chunk) [Note 11. Development and License Agreements](index=29&type=section&id=Note%2011.%20Development%20and%20License%20Agreements) Cerus has a supply agreement with Fresenius and government contracts (BARDA, FDA, DoD) funding R&D for pathogen reduction technologies - The 2022 Agreement with Fresenius for manufacturing disposable kits for platelet and plasma systems extends until **December 31, 2031**[104](index=104&type=chunk) - BARDA committed funding under the 2016 BARDA Agreement increased to **$185.5 million** as of June 30, 2025, with a total funding opportunity of **$270.2 million** through September 2026 if subsequent Option Periods are exercised[107](index=107&type=chunk) - The 2024 BARDA Agreement includes committed funding of up to **$32.1 million** for the base period, with a total funding opportunity of **$188.4 million** if subsequent option periods are exercised, supporting the red blood cell system's development[108](index=108&type=chunk) - The DoD agreement for pathogen-reduced, lyophilized cryoprecipitate was extended to **February 2027**, increasing the total contract value from **$9.1 million** to **$17.8 million**[110](index=110&type=chunk) [Note 12. Segment, Customer and Geographic Information](index=33&type=section&id=Note%2012.%20Segment%2C%20Customer%20and%20Geographic%20Information) Cerus operates as one segment, with U.S. and European operations, and key customers including American Red Cross and Établissement Français du Sang - The company operates in one reportable segment, with the CEO as the Chief Operating Decision Maker[113](index=113&type=chunk) Significant Customers (% of Total Product Revenue) | Customer | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :---------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | American Red Cross | 33% | 36% | 36% | 36% | | OneBlood | 11% | * | * | * | | Établissement Français du Sang | 10% | 11% | 10% | 13% | - The One Big Beautiful Bill Act (OBBBA) was enacted on **July 4, 2025**[117](index=117&type=chunk) [Note 13. Subsequent Events](index=33&type=section&id=Note%2013.%20Subsequent%20Events) The One Big Beautiful Bill Act (OBBBA) was enacted in July 2025, amending U.S. tax law, with its financial impact under evaluation - The One Big Beautiful Bill Act (OBBBA) was enacted on **July 4, 2025**[117](index=117&type=chunk) - OBBBA amends U.S. tax law, including provisions related to bonus depreciation, research and development expenses, and foreign derived intangible income[117](index=117&type=chunk) - The company is currently evaluating the impact of OBBBA on its condensed consolidated financial statements[117](index=117&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Cerus Corporation's financial performance, liquidity, and capital resources, highlighting revenue growth, operating expenses, and INTERCEPT Blood System development [Overview](index=36&type=section&id=Overview) Cerus commercializes INTERCEPT Blood System for platelets/plasma, develops the red blood cell system, and relies on government funding and capital for growth - The INTERCEPT Blood System for platelets and plasma is marketed and sold globally, including the U.S. and Europe, with FDA approval and CE Certificates of Conformity[121](index=121&type=chunk)[122](index=122&type=chunk) - The red blood cell system is currently in development and has not been commercialized; its MDR application in Europe was closed due to insufficient data on impurity profiles, requiring resubmission and ongoing product development costs[123](index=123&type=chunk)[125](index=125&type=chunk) - For U.S. FDA approval of the red blood cell system, additional clinical trial data (beyond ReCePI and RedeS studies) is anticipated, with RedeS enrollment expected by end of **2025** and completion in **H2 2026**[125](index=125&type=chunk) - The company relies on BARDA agreements for significant funding for the red blood cell system's development, but faces risks of funding reductions or delays, potentially requiring self-funding or additional capital[126](index=126&type=chunk) - Commercialization of INTERCEPT Fibrinogen Complex (IFC) in the U.S. is dependent on blood center partners obtaining site-specific BLAs from the FDA, with delays impacting nationwide availability[127](index=127&type=chunk)[128](index=128&type=chunk) [Fresenius](index=42&type=section&id=Fresenius) Fresenius manufactures INTERCEPT platelet and plasma systems; production delays could hinder Cerus's growth and increase costs - Fresenius is the sole manufacturer and supplier of disposable kits for the INTERCEPT platelet and plasma systems under an agreement until **December 31, 2031**[138](index=138&type=chunk) - Delays in Fresenius qualifying and licensing new production facilities may adversely impact Cerus's ability to grow its platelet and plasma business[139](index=139&type=chunk) [Government contracts](index=42&type=section&id=Government%20contracts) Cerus holds BARDA, FDA, and DoD contracts funding pathogen reduction R&D, subject to audits, termination, and cost restrictions - The 2016 BARDA Agreement provides up to **$185.5 million** in committed funding for red blood cell system development, but BARDA will no longer exercise unexercised options[142](index=142&type=chunk)[143](index=143&type=chunk) - The 2024 BARDA Agreement offers up to **$32.1 million** in committed funding for its base period, with a total funding opportunity of **$188.4 million** if subsequent options are exercised, supporting FDA PMA application and improved red blood cell system development[144](index=144&type=chunk) - A five-year agreement with the FDA for next-generation pathogen reduction compounds has a total contract value of **$11.1 million**[145](index=145&type=chunk) - The DoD agreement for pathogen-reduced, lyophilized cryoprecipitate was amended to extend to **February 2027** and increased to a total contract value of **$17.8 million**[146](index=146&type=chunk) [Equity Agreements](index=44&type=section&id=Equity%20Agreements) Equity agreement details are provided in Note 8, Stockholders' Equity - Information on equity agreements is detailed in Note 8, Stockholders' Equity[147](index=147&type=chunk) [Debt Agreements](index=44&type=section&id=Debt%20Agreements) Debt agreement details are provided in Note 5, Debt - Information on debt agreements is detailed in Note 5, Debt[148](index=148&type=chunk) [Critical Accounting Policies and Management Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Management%20Estimates) Critical accounting policies and estimates remain consistent with the 2024 Annual Report on Form 10-K - Critical accounting policies and significant estimates have not substantially changed from the 2024 Annual Report on Form 10-K[149](index=149&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) Cerus saw revenue growth and narrowed net loss in H1 2025, despite increased R&D and SG&A, with non-operating expenses impacted by foreign exchange [Revenue](index=45&type=section&id=Revenue) Total revenue grew 19% to $60.1 million (Q2) and 16% to $109.0 million (H1) in 2025, driven by product and BARDA contract revenue Revenue (in thousands, except percentages) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Product revenue | $52,445 | $45,079 | $7,366 | 16% | $95,684 | $83,444 | $12,240 | 15% | | Government contract revenue | $7,684 | $5,440 | $2,244 | 41% | $13,298 | $10,470 | $2,828 | 27% | | Total revenue | $60,129 | $50,519 | $9,610 | 19% | $108,982 | $93,914 | $15,068 | 16% | - Product revenue growth was primarily due to increased sales volume of disposable platelet kits in Europe for the three-month period and to U.S. customers for the six-month period[150](index=150&type=chunk) - Government contract revenue increased due to higher revenue from BARDA, particularly from the 2024 BARDA Agreement executed in **Q4 2024**[151](index=151&type=chunk) [Cost of Product Revenue](index=45&type=section&id=Cost%20of%20Product%20Revenue) Cost of product revenue increased, with gross margin at 55% (Q2) and 57% (H1), influenced by product mix and favorable variances Cost of Product Revenue (in thousands, except percentages) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Cost of product revenue | $23,470 | $20,413 | $3,057 | 15% | $41,285 | $37,506 | $3,779 | 10% | - Gross margin on product sales was **55%** for the three months ended June 30, 2025 and 2024, and **57%** for the six months ended June 30, 2025, up from **55%** in the prior year[154](index=154&type=chunk) - The increase in six-month gross margin was primarily due to capitalization of inventoriable charges and nonrecurring release of previously accounted for favorable variances[154](index=154&type=chunk) [Research and Development Expenses](index=46&type=section&id=Research%20and%20Development%20Expenses) R&D expenses rose 26% (Q2) and 21% (H1) to $18.9 million and $35.5 million, driven by new illuminator, compensation, and BARDA activities Research and Development Expenses (in thousands, except percentages) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $18,900 | $14,969 | $3,931 | 26% | $35,505 | $29,451 | $6,054 | 21% | - The increase was primarily driven by costs related to the new LED-based illuminator, increased compensation, and work performed related to BARDA agreements[157](index=157&type=chunk) - Additional R&D costs are expected due to inflationary pressures, regulatory approvals for new products/geographies, and ongoing clinical development of the red blood cell system[158](index=158&type=chunk) [Selling, General and Administrative Expenses](index=46&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) SG&A expenses increased 12% (Q2) and 7% (H1) to $21.2 million and $41.5 million, mainly due to higher compensation costs Selling, General and Administrative Expenses (in thousands, except percentages) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Selling, general and administrative | $21,182 | $18,973 | $2,209 | 12% | $41,468 | $38,772 | $2,696 | 7% | - The increase was primarily driven by increased compensation costs[160](index=160&type=chunk) - Additional SG&A costs are expected due to inflationary pressures on labor and vendor costs, and escalating trade tensions and tariffs[159](index=159&type=chunk) [Non-Operating Expense, Net](index=46&type=section&id=Non-Operating%20Expense%2C%20Net) Non-operating expense, net, increased 11% (Q2) and 10% (H1) to $2.2 million and $4.0 million, driven by foreign exchange losses Non-Operating Expense, Net (in thousands, except percentages) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :---------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Foreign exchange (loss) gain | $(911) | $(77) | $(834) | 1,083% | $(1,198) | $68 | $(1,266) | (1,862%) | | Interest expense | $(2,150) | $(2,330) | $180 | (8%) | $(4,260) | $(4,564) | $304 | (7%) | | Other income, net | $845 | $412 | $433 | 105% | $1,451 | $864 | $587 | 68% | | Total non-operating expense, net | $(2,216) | $(1,995) | $(221) | 11% | $(4,007) | $(3,632) | $(375) | 10% | [Foreign Exchange (Loss) Gain](index=47&type=section&id=Foreign%20Exchange%20%28Loss%29%20Gain) Foreign exchange losses occurred in Q2 and H1 2025, primarily due to Euro-U.S. dollar exchange rate fluctuations - Foreign exchange loss for the three months ended June 30, 2025, was **$(911) thousand**, compared to **$(77) thousand** in 2024[163](index=163&type=chunk) - Foreign exchange loss for the six months ended June 30, 2025, was **$(1,198) thousand**, compared to a gain of **$68 thousand** in 2024[163](index=163&type=chunk) - These fluctuations are primarily due to foreign exchange variations between the Euro and the U.S. dollar[164](index=164&type=chunk) [Interest Expense](index=47&type=section&id=Interest%20Expense) Interest expense decreased by 8% (Q2) and 7% (H1) due to lower interest rates on the Term Loan - Interest expense decreased by **$180 thousand (8%)** for the three months ended June 30, 2025, and by **$304 thousand (7%)** for the six months ended June 30, 2025[163](index=163&type=chunk) - The decrease was primarily due to a decrease in interest rates on the Term Loan[165](index=165&type=chunk) [Other Income, net](index=47&type=section&id=Other%20Income%2C%20net) Other income, net, increased 105% (Q2) to $845 thousand and 68% (H1) to $1.451 million in 2025 - Other income, net, increased by **$433 thousand (105%)** for the three months ended June 30, 2025[163](index=163&type=chunk) - Other income, net, increased by **$587 thousand (68%)** for the six months ended June 30, 2025[163](index=163&type=chunk) [Provision for Income Taxes](index=47&type=section&id=Provision%20for%20Income%20Taxes) Income tax expense was $76 thousand (Q2) and $150 thousand (H1) from the European subsidiary, with a U.S. deferred tax valuation allowance Provision for (benefit from) Income Taxes (in thousands, except percentages) | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Provision for (benefit from) income taxes | $76 | $(56) | $132 | (236%) | $150 | $18 | $132 | 733% | - Tax expenses were primarily a result of the Cerus Europe B.V. subsidiary's activities[167](index=167&type=chunk) - Substantially all U.S. deferred tax assets are subject to a valuation allowance due to cumulative operating losses[168](index=168&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) Cerus's liquidity, totaling $79.2 million, relies on diverse capital sources, with operating cash flow shifting to negative due to inventory Cash, Cash Equivalents, Short-term Investments, and Restricted Cash (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $15,991 | $20,266 | | Short-term investments | $62,034 | $60,186 | | Restricted cash | $1,140 | $1,095 | | Total | $79,165 | $81,547 | Indebtedness (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Debt – current | $28,125 | $19,297 | | Debt – non-current | $56,766 | $64,862 | | Total | $84,891 | $84,159 | - Net cash used in operating activities was **$(3,290) thousand** for the six months ended June 30, 2025, compared to net cash provided of **$2,360 thousand** in the same period of 2024, primarily due to increased inventory purchases[171](index=171&type=chunk) - Working capital decreased to **$84,584 thousand** at June 30, 2025, from **$88,890 thousand** at December 31, 2024, mainly due to increased accounts payable and accrued liabilities, and reclassification of long-term debt to short-term[174](index=174&type=chunk) - The company believes its available cash, cash equivalents, short-term investments, and cash from product sales and government contracts will be sufficient for at least the next **12 months**[176](index=176&type=chunk) [Commitments](index=52&type=section&id=Commitments) Financial commitments are detailed in Notes 5, 6, and 7; no off-balance sheet arrangements existed - Detailed information on commitments can be found in Note 5 (Debt), Note 6 (Leases), and Note 7 (Commitments and Contingencies)[185](index=185&type=chunk) - The company did not have any off-balance sheet arrangements as of June 30, 2025[186](index=186&type=chunk) [Financial Instruments](index=53&type=section&id=Financial%20Instruments) Investment policy prioritizes principal preservation and liquidity, with no credit losses recorded on Level 1 and Level 2 financial instruments - Cash and cash equivalents are invested in money market funds (Level 1)[187](index=187&type=chunk) - Available-for-sale securities (corporate debt, U.S. government agency securities) are classified as Level 2[187](index=187&type=chunk) - No credit losses were recorded during the three and six months ended June 30, 2025 and 2024[187](index=187&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures occurred during the six months ended June 30, 2025 - No material changes to market risk disclosures occurred during the six months ended June 30, 2025[188](index=188&type=chunk) [Item 4. Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=53&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) CEO and CFO concluded disclosure controls and procedures were effective as of June 30, 2025 - CEO and CFO concluded that disclosure controls and procedures are effective as of June 30, 2025[189](index=189&type=chunk) [Changes

Executive Summary & Business Outlook Cerus Corporation reported strong Q2 2025 commercial and financial results, driven by INTERCEPT product growth and pipeline advancements, leading to an upward revision of full-year 2025 product revenue guidance [CEO Commentary](index=1&type=section&id=CEO%20Commentary) Cerus Corporation's CEO highlighted strong Q2 2025 commercial results, driven by the INTERCEPT product portfolio and global adoption, with advancements in the product development pipeline and an upward revision of full-year 2025 product revenue guidance - Commercial results in Q2 2025 demonstrate progress in multiple geographies and across the INTERCEPT product portfolio, with a singular focus on advancing blood safety and availability[4](index=4&type=chunk) - The early launch and adoption of the next-generation, LED-based INT200 illumination device continue to surpass expectations regarding performance and customer experience[4](index=4&type=chunk) - Advancements in the product development pipeline are encouraging, including the early resubmission for RBC CE Mark and the recent DoD award for the CRYO-First study[4](index=4&type=chunk) - Strong commercial and financial execution in Q2 resulted in record product sales, a year-over-year narrowing of net loss attributable to Cerus, and another quarter of positive non-GAAP adjusted EBITDA[5](index=5&type=chunk) [Key Financial Highlights (Q2 2025)](index=1&type=section&id=Key%20Financial%20Highlights%20(Q2%202025)) Cerus reported robust financial performance for Q2 2025, with total revenue reaching $60.1 million, a 19% increase year-over-year, driven by record product revenue and positive non-GAAP adjusted EBITDA | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Total Revenue | $60.1 | $50.5 | $9.6 | 19% | | Product Revenue | $52.4 | $45.1 | $7.4 | 16% | | Government Contract Revenue | $7.7 | $5.4 | $2.2 | 41% | | IFC Revenue | $5.6 | $2.0 | $3.6 | 180% | | Net Loss Attributable to Cerus | $(5.7) | $(5.8) | $0.1 | -1.7% | | Non-GAAP Adjusted EBITDA | $0.9 | $0.8 | $0.1 | 12.5% | - Customer demand for Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (IFC) continues to increase, with Q2 IFC revenue reaching **$5.6 million**, a significant increase from **$2.0 million** in the prior year period[5](index=5&type=chunk)[6](index=6&type=chunk) - Cash, cash equivalents, and short-term investments stood at **$78.0 million** at June 30, 2025[10](index=10&type=chunk)[16](index=16&type=chunk) [Full-Year 2025 Guidance Update](index=1&type=section&id=Full-Year%202025%20Guidance%20Update) Cerus Corporation has raised its full-year 2025 product revenue guidance range to $200 million - $203 million, reflecting strong first-half performance and anticipated second-half growth | Metric | Previous Guidance (Millions $) | Updated Guidance (Millions $) | Change (Millions $) | | :-------------------- | :----------------------------- | :---------------------------- | :------------------ | | Full-Year 2025 Product Revenue | $194 - $200 | $200 - $203 | Up $3 - $6 | | Full-Year 2025 IFC Revenue | $12 - $15 | $16 - $18 | Up $3 - $4 | - The company remains committed to its goal of achieving positive, full-year 2025 non-GAAP adjusted EBITDA[5](index=5&type=chunk)[15](index=15&type=chunk) Second Quarter 2025 Financial Results Cerus Corporation's Q2 2025 financial results demonstrate strong revenue growth across product and government contracts, alongside strategic investments in operating expenses, leading to a narrowed net loss and positive adjusted EBITDA [Total Revenue Analysis](index=1&type=section&id=Total%20Revenue%20Analysis) Cerus' total revenue for Q2 2025 increased by 19% year-over-year to $60.1 million, driven by strong product revenue growth and a significant increase in government contract revenue | Revenue Type | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Product Revenue | $52.4 | $45.1 | $7.4 | 16% | | Government Contract Revenue | $7.7 | $5.4 | $2.2 | 41% | | Total Revenue | $60.1 | $50.5 | $9.6 | 19% | [Product Revenue](index=1&type=section&id=Product%20Revenue) Product revenue for Q2 2025 reached a record $52.4 million, a 16% increase from the prior year, primarily fueled by strong global platelet sales and a substantial increase in U.S. sales of INTERCEPT Fibrinogen Complex (IFC) | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Product Revenue | $52.4 | $45.1 | $7.4 | 16% | | U.S. IFC Sales | $5.6 | $2.0 | $3.6 | 180% | - The year-over-year increase in product revenue was led by growth in IFC and global platelet sales[6](index=6&type=chunk) [Government Contract Revenue](index=1&type=section&id=Government%20Contract%20Revenue) Government contract revenue increased by 41% to $7.7 million in Q2 2025, primarily supporting R&D activities for the INTERCEPT RBC program, next-generation pathogen reduction technology, and lyophilized IFC development | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Government Contract Revenue | $7.7 | $5.4 | $2.2 | 41% | - Revenue was comprised of funding for R&D activities related to the INTERCEPT RBC program, next-generation pathogen reduction technology for whole-blood, and development of lyophilized IFC[7](index=7&type=chunk) - The increase was primarily driven by increasing enrollment in the Phase 3 RedeS trial and activities for the advancement of the INTERCEPT RBC system under BARDA contracts[7](index=7&type=chunk) [Revenue by Region](index=8&type=section&id=Revenue%20by%20Region) North America and EMEA regions showed significant product revenue growth in Q2 2025, with North America increasing by 17% and EMEA by 21%, while the 'Other' category experienced a decline | Region | Q2 2025 (Thousands $) | Q2 2024 (Thousands $) | Change ($) | Change (%) | | :-------------------------- | :-------------------- | :-------------------- | :--------- | :--------- | | North America | $35,286 | $30,097 | $5,189 | 17% | | Europe, Middle East and Africa | $16,612 | $13,725 | $2,887 | 21% | | Other | $547 | $1,257 | $(710) | -56% | | Total product revenue | $52,445 | $45,079 | $7,366 | 16% | [Product Gross Profit and Margin](index=2&type=section&id=Product%20Gross%20Profit%20and%20Margin) Product gross profit for Q2 2025 increased by 17% to $29.0 million, aligning with revenue growth, while the product gross margin remained relatively stable at 55.2% | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Product Gross Profit | $29.0 | $24.7 | $4.3 | 17% | | Product Gross Margin | 55.2% | 54.7% | 0.5 pp | - | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses for Q2 2025 increased by 18% to $40.1 million, reflecting strategic investments in both R&D and SG&A to drive future revenue growth | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | Total Operating Expenses | $40.1 | $33.9 | $6.2 | 18% | - The increase in operating expenses reflects investments in the business to drive future revenue growth[9](index=9&type=chunk) [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses rose by 26% to $18.9 million in Q2 2025, driven by development costs for the new LED-based INT200 device, higher government contract costs, and elevated employee compensation | Metric | Q2 2025 (Millions $) | Q2 2024 (Millions $) | Change ($) | Change (%) | | :-------------------- | :------------------- | :------------------- | :--------- | :--------- | | R&D Expenses | $18.9 | $15.0 | $3.9 | 26% | - Primary drivers for the increase were development costs on INT200, higher government contract costs, and higher employee compensation expenses[10](index=10&type=chunk)[11](index=11&type=chunk) - The European regulatory review of the CE Mark application

Financial Performance & Guidance - Cerus is raising its full-year 2024 product revenue guidance to $177 - $179 million, anticipating a 12-14% increase compared to full-year 2023 product revenue[13] - The bottom end of the 2024 IFC guidance range has been raised to $9 - $10 million, from the prior $8 - $10 million[13] - In Q3 2024, Non-GAAP Adjusted EBITDA reached $4.4 million[32] Product & Market - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential growth to over $1.5 billion in 5-7 years[22] - The U S addressable market is $150 million, with potential growth to over $200 million in 5-7 years[22] - Cerus' preliminary 2023 product revenue was $156 million[22] Strategic Initiatives - Cerus has a new BARDA contract for INTERCEPT RBCs[11] - The company submitted a CE Mark for its LED Illuminator[11] - Cerus is focused on adjusted EBITDA and operating cash flow goals[25]

Financial Performance & Outlook - Cerus achieved positive non-GAAP adjusted EBITDA for Q4 and full year 2024 [9] - The company anticipates product revenue growth of 8% to 11% year-over-year in 2025 [9] - Cerus is committed to sustaining positive adjusted EBITDA for fiscal year 2025 [9] - GAAP net loss attributable to Cerus improved by over 40% in 2024 compared to 2023 [9] - In 2024, Cerus achieved 15% topline growth due to strong team performance and blood center partnerships [10] Market & Product Expansion - Cerus is focused on the continued global expansion of its platelet franchise [9] - The company expects increasing uptake of INTERCEPT Fibrinogen Complex (IFC) in the US [9] - The global addressable market for INTERCEPT products is currently $1.3 billion and is expected to grow to over $1.5 billion in the next 5-7 years [16] - The U S addressable market is $150 million and is expected to grow to over $200 million in the next 5-7 years [16] Technology & Impact - Cumulative kit sales for over 16 million INTERCEPT treated doses of platelets & plasma [5]

Financial Performance & Guidance - Cerus' annual product revenue has shown consistent growth from 2017 to 2022, with a compound annual growth rate (CAGR) of 30%[10] - In 2022, Cerus achieved product revenues of $162 million[33] - The company projects 2023 product revenue to be in the range of $165 million to $170 million[51] - Cerus anticipates reaching cash flow breakeven during 2023 and expects improvement across margins, cash flow, and operating expense leverage[3, 51] Market Opportunity & Growth Strategy - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential to grow to over $1.5 billion in the next 5-7 years[33] - The U S market represents a $150 million opportunity, expected to exceed $200 million in 5-7 years[33] - Cerus is focused on geographic expansion, including new markets like China, to extend its global reach[3, 53] Technology & Product - The INTERCEPT Blood System targets DNA and RNA to prevent pathogen proliferation in blood products[19, 20] - Over 10 million cumulative kits of INTERCEPT-treated blood products have been sold[40] - Cerus has an FDA-approved product for pathogen-reduced platelets in the U S [20, 58]

Financial Data and Key Metrics Changes - The company achieved a positive non-GAAP adjusted EBITDA for 2024 and is committed to maintaining this for 2025, indicating an improving financial profile [7][42] - Current revenue guidance for 2025 is between $194 million to $200 million, representing a sub-10% penetration of the total addressable market (TAM) of $2.5 billion for existing licensed products [8][11] Business Line Data and Key Metrics Changes - The INTERCEPT Fibrinogen Complex product is projected to generate $12 million to $15 million in revenue for 2025, showing significant growth potential [11][31] - The INTERCEPT technology has been developed to treat all four transfused blood components: platelets, plasma, red cells, and fibrinogen complex, with a strong market presence in the platelet transfusion sector [4][5] Market Data and Key Metrics Changes - The total addressable market for the platelet opportunity is expected to reach at least $1.5 billion by 2030, with organic growth in the platelet market typically ranging from 3% to 5% annually [9][10] - The red cell market opportunity is the largest, estimated at $5 billion globally, highlighting the importance of getting the INTERCEPT Red Cell program approved [10] Company Strategy and Development Direction - The company aims to extend its leadership position in the INTERCEPT blood system for platelets and plasma, targeting additional market share in the U.S. and expanding into markets like China, Brazil, and Germany [42][43] - The focus is on developing real-world outcomes data for the INTERCEPT Fibrinogen Complex and targeting international opportunities [44] Management's Comments on Operating Environment and Future Outlook - Management emphasized the strong and improving financial profile, with sustained revenue growth expected through the end of the decade due to existing and new products [7][42] - The company is well-positioned to leverage its established customer base and recurring revenue model to drive growth [5][6] Other Important Information - The company has a strong cash position, which supports its growth initiatives and operational stability [7] - The INTERCEPT technology addresses significant unmet needs in transfusion medicine, particularly in pathogen reduction and safety [15][18] Q&A Session Summary Question: What is the outlook for the INTERCEPT Red Cell program? - The company is nearing completion of enrollment for the ReCePI study in the U.S., which is required for the PMA submission with the FDA [34] Question: How is the INTERCEPT Fibrinogen Complex performing in the market? - The product is gaining traction in major academic hospitals, with a projected revenue of $12 million to $15 million for 2025 and a significant market opportunity in the U.S. [31][32]

Group 1 - Cerus reported a quarterly loss of $0.04 per share, better than the Zacks Consensus Estimate of a loss of $0.05, representing an earnings surprise of 20% [1] - The company posted revenues of $43.24 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 2.95%, and up from $38.37 million a year ago [2] - Cerus has surpassed consensus EPS estimates three times over the last four quarters [2] Group 2 - The stock has underperformed, losing about 14.3% since the beginning of the year, compared to the S&P 500's decline of 5.3% [3] - The current consensus EPS estimate for the coming quarter is -$0.02 on revenues of $49.5 million, and -$0.10 on revenues of $198 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Products is in the bottom 28% of over 250 Zacks industries, indicating potential challenges for stock performance [8]