[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) This section details the Form 10-Q filing, registrant status, outstanding shares, and stock exchange listing [Filing Details](index=1&type=section&id=Filing%20Details) Confirms Form 10-Q filing, registrant status, outstanding shares, and stock exchange listing - The registrant is a **large accelerated filer** and has filed all required reports during the preceding 12 months[2](index=2&type=chunk) - As of October 21, 2019, there were **142,088,830 shares** of the registrant's common stock outstanding[2](index=2&type=chunk) - The company's common stock (CERS) is registered on The Nasdaq Stock Market LLC[4](index=4&type=chunk) [PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents unaudited condensed consolidated financial statements and management's discussion and analysis [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Presents Cerus Corporation's unaudited condensed consolidated financial statements and detailed notes [Unaudited Condensed Consolidated Balance Sheets](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Balance sheets show slight asset increase, notable liability increase, and decreased stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Category | Sep 30, 2019 | Dec 31, 2018 | | :-------------------------- | :----------- | :----------- | | Total Assets | $164,438 | $163,460 | | Total Liabilities | $103,630 | $78,941 | | Total Stockholders' Equity | $60,808 | $84,519 | | Current Assets | $126,317 | $146,902 | | Current Liabilities | $45,559 | $52,678 | [Unaudited Condensed Consolidated Statements of Operations](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) Statements of operations show increased revenue, higher R&D and SG&A expenses, and a larger net loss Key Operating Results (in thousands, except per share data) | Category | Three Months Sep 2019 | Three Months Sep 2018 | Nine Months Sep 2019 | Nine Months Sep 2018 | | :----------------------------------- | :-------------------- | :-------------------- | :------------------- | :------------------- | | Product revenue | $18,019 | $15,399 | $53,732 | $44,383 | | Government contract revenue | $4,827 | $3,928 | $13,554 | $11,430 | | Total operating expenses | $32,221 | $24,789 | $92,979 | $72,151 | | Net loss | $(17,967) | $(14,192) | $(54,321) | $(41,359) | | Net loss per share (Basic and diluted) | $(0.13) | $(0.11) | $(0.39) | $(0.32) | - Product revenue increased by **17%** for the three months and **21%** for the nine months ended September 30, 2019, year-over-year[13](index=13&type=chunk) - Research and development expenses increased by **49%** for the three months and **46%** for the nine months ended September 30, 2019, year-over-year[13](index=13&type=chunk) [Unaudited Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Statements of comprehensive loss detail net loss and other comprehensive income/loss from available-for-sale investments Comprehensive Loss (in thousands) | Category | Three Months Sep 2019 | Three Months Sep 2018 | Nine Months Sep 2019 | Nine Months Sep 2018 | | :------------------------------------------------------ | :-------------------- | :-------------------- | :------------------- | :------------------- | | Net loss | $(17,967) | $(14,192) | $(54,321) | $(41,359) | | Unrealized gains (losses) on available-for-sale investments, net of taxes | $48 | $91 | $420 | $(229) | | Comprehensive loss | $(17,919) | $(14,101) | $(53,901) | $(41,588) | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity statements detail changes from December 2018 to September 2019, reflecting stock issuances, compensation, and net losses Stockholders' Equity Changes (in thousands) | Category | Dec 31, 2018 | Sep 30, 2019 | | :---------------------------------------------------------------------------------------------------- | :----------- | :----------- | | Total Stockholders' Equity | $84,519 | $60,808 | | Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (9 months) | $684 (Q1), $558 (Q2), $1,586 (Q3) | | | Issuance of common stock from public offering, net of offering costs (9 months) | $9,836 (Q2), $7,914 (Q3) | | | Stock-based compensation (9 months) | $2,878 (Q1), $3,139 (Q2), $3,595 (Q3) | | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements show increased cash used in operations, a shift to cash provided by investing, and reduced cash from financing Cash Flow Summary (in thousands) | Category | Nine Months Sep 2019 | Nine Months Sep 2018 | | :-------------------------------------------------- | :------------------- | :------------------- | | Net cash used in operating activities | $(57,277) | $(24,151) | | Net cash provided by (used in) investing activities | $18,784 | $(51,075) | | Net cash provided by financing activities | $34,003 | $86,352 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(4,490) | $11,126 | | Cash, cash equivalents and restricted cash, end of period | $27,097 | $25,056 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes explain accounting policies, financial instruments, inventory, liabilities, debt, commitments, equity, compensation, taxes, and agreements [Note 1. Summary of Significant Accounting Policies](index=8&type=section&id=Note%201.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines significant accounting policies, including revenue recognition, R&D, cash, investments, inventory, stock compensation, income taxes, and new pronouncements - The company's main source of revenue is product sales of the INTERCEPT Blood System (platelet and plasma systems, illuminators, spare parts, maintenance services)[29](index=29&type=chunk) - Revenue from the BARDA government contract is recognized as qualified direct and indirect costs are incurred[31](index=31&type=chunk) Product Revenue by Geographical Location (in thousands) | Region | Three Months Sep 2019 | Three Months Sep 2018 | Nine Months Sep 2019 | Nine Months Sep 2018 | | :--------------------------- | :-------------------- | :-------------------- | :------------------- | :------------------- | | Europe, Middle East and Africa | $12,806 | $11,866 | $38,207 | $34,890 | | North America | $4,792 | $3,117 | $14,501 | $8,653 | | Other | $421 | $416 | $1,024 | $840 | | **Total product revenue** | **$18,019** | **$15,399** | **$53,732** | **$44,383** | - The company adopted ASU No. 2016-02 (Leases) on January 1, 2019, recognizing **$2.4 million** in right-of-use assets and lease liabilities[71](index=71&type=chunk) [Note 2. Available-for-sale Securities and Fair Value on Financial Instruments](index=14&type=section&id=Note%202.%20Available-for-sale%20Securities%20and%20Fair%20Value%20on%20Financial%20Instruments) This note details available-for-sale securities, including money market funds, U.S. government agency securities, and corporate debt, with fair value measurements Available-for-sale Securities at September 30, 2019 (in thousands) | Category | Amortized Cost | Unrealized Gross Gain | Unrealized Gross Loss | Fair Value | | :--------------------------------- | :------------- | :-------------------- | :-------------------- | :--------- | | Money market funds | $10,493 | $— | $— | $10,493 | | United States government agency securities | $14,511 | $8 | $— | $14,519 | | Corporate debt securities | $46,036 | $131 | $— | $46,167 | | **Total available-for-sale securities** | **$71,040** | **$139** | **$—** | **$71,179** | Available-for-sale Securities at December 31, 2018 (in thousands) | Category | Amortized Cost | Unrealized Gross Gain | Unrealized Gross Loss | Fair Value | | :--------------------------------- | :------------- | :-------------------- | :-------------------- | :--------- | | Money market funds | $6,167 | $— | $— | $6,167 | | United States government agency securities | $15,971 | $— | $(23) | $15,948 | | Corporate debt securities | $73,028 | $2 | $(260) | $72,770 | | **Total available-for-sale securities** | **$95,166** | **$2** | **$(283)** | **$94,885** | Fair Value Hierarchy of Financial Assets at September 30, 2019 (in thousands) | Category | Total | Level 1 | Level 2 | Level 3 | | :--------------------------------- | :------ | :------ | :------ | :------ | | Money market funds | $10,493 | $10,493 | $— | $— | | United States government agency securities | $14,519 | $— | $14,519 | $— | | Corporate debt securities | $46,167 | $— | $46,167 | $— | | **Total financial assets** | **$71,179** | **$10,493** | **$60,686** | **$—** | [Note 3. Inventories](index=16&type=section&id=Note%203.%20Inventories) Inventory, comprising work-in-process and finished goods, increased from December 2018 to September 2019 Inventories (in thousands) | Category | Sep 30, 2019 | Dec 31, 2018 | | :---------------- | :----------- | :----------- | | Work-in-process | $5,453 | $3,075 | | Finished goods | $15,453 | $10,464 | | **Total inventories** | **$20,906** | **$13,539** | [Note 4. Accrued Liabilities](index=16&type=section&id=Note%204.%20Accrued%20Liabilities) Accrued liabilities slightly decreased from December 2018 to September 2019, mainly due to reduced compensation Accrued Liabilities (in thousands) | Category | Sep 30, 2019 | Dec 31, 2018 | | :----------------------------------- | :----------- | :----------- | | Accrued compensation and related costs | $9,082 | $10,765 | | Accrued professional services | $4,337 | $4,544 | | Accrued development costs | $1,804 | $1,965 | | Other accrued expenses | $3,226 | $2,526 | | **Total accrued liabilities** | **$18,449** | **$19,800** | [Note 5. Debt](index=16&type=section&id=Note%205.%20Debt) The company refinanced its debt in March 2019 with MidCap Financial Trust, replacing the Oxford Term Loan and incurring a $2.1 million extinguishment loss Debt at September 30, 2019 (in thousands) | Category | Principal | Unamortized Discount | Total | | :------------------------- | :-------- | :------------------- | :------ | | Term Loan Credit Agreement | $40,000 | $(629) | $39,371 | | **Debt – non-current** | **$40,000** | **$(629)** | **$39,371** | Debt at December 31, 2018 (in thousands) | Category | Principal | Unamortized Discount | Net Carrying Value | | :------------------------- | :-------- | :------------------- | :----------------- | | Oxford Term Loan Agreement | $30,000 | $(130) | $29,870 | | Less: debt – current | $(7,857) | $— | $(7,857) | | **Debt – non-current** | **$22,143** | **$(130)** | **$22,013** | - On March 29, 2019, the company drew **$40.0 million** from a new Term Loan Credit Agreement with MidCap Financial Trust, using proceeds to repay the Oxford Term Loan Agreement, resulting in a **$2.1 million** loss on extinguishment[87](index=87&type=chunk) - As of September 30, 2019, the company had borrowed approximately **$5.0 million** under a Revolving Loan Credit Agreement with MidCap[88](index=88&type=chunk) [Note 6. Commitments and Contingencies](index=17&type=section&id=Note%206.%20Commitments%20and%20Contingencies) This note details operating lease commitments for facilities and equipment, outlining future minimum non-cancelable payments Future Minimum Non-Cancelable Operating Lease Payments (in thousands) | Year Ended December 31, | Operating Leases | | :------------------------ | :--------------- | | Remainder of 2019 | $854 | | 2020 | $3,114 | | 2021 | $3,139 | | 2022 | $2,768 | | 2023 | $2,644 | | Thereafter | $18,701 | | **Total future lease payments** | **$31,220** | | Less imputed interest | $11,170 | | **Present value of lease liabilities** | **$20,050** | - Weighted-average remaining lease term was **9.6 years** and weighted-average discount rate was **9.0%** as of September 30, 2019[91](index=91&type=chunk) [Note 7. Stockholders' Equity](index=18&type=section&id=Note%207.%20Stockholders%27%20Equity) The company sold **3.5 million** shares for **$17.7 million** net proceeds, with **$23.5 million** remaining available - During the nine months ended September 30, 2019, **3.5 million** shares of common stock were sold under the Amended Cantor Agreement for net proceeds of **$17.7 million**[95](index=95&type=chunk) - As of September 30, 2019, approximately **$23.5 million** of common stock remained available for sale under the Amended Cantor Agreement[95](index=95&type=chunk) [Note 8. Stock-Based Compensation](index=18&type=section&id=Note%208.%20Stock-Based%20Compensation) This note details stock option and restricted stock unit activity under equity incentive plans for the nine months ended September 30, 2019 Stock Options Activity (in thousands, except per share amounts) | | Number of Options Outstanding | Weighted Average Exercise Price per Share | | :-------------------------- | :---------------------------- | :---------------------------------------- | | Balances at December 31, 2018 | 17,560 | $4.47 | | Granted | 515 | $5.68 | | Exercised | (586) | $3.05 | | Forfeited/canceled | (410) | $5.54 | | **Balances at September 30, 2019** | **17,079** | **$4.53** | Restricted Stock Units (RSUs) Activity (in thousands, except per share amounts) | | Number of RSUs Unvested | Weighted Average Grant Date Fair Value per Share | | :-------------------------- | :------------------------ | :----------------------------------------------- | | Balances at December 31, 2018 | 2,001 | $4.56 | | Granted | 3,167 | $5.57 | | Vested | (879) | $4.68 | | Forfeited | (193) | $5.98 | | **Balances at September 30, 2019** | **4,096** | **$5.25** | - As of September 30, 2019, approximately **31.5 million** shares were subject to outstanding options or unvested RSUs, or remained available for future issuance under the Amended 2008 Plan[100](index=100&type=chunk) [Note 9. Income Taxes](index=19&type=section&id=Note%209.%20Income%20Taxes) Income tax expense remained consistent at **$0.1 million** (three months) and **$0.2 million** (nine months) for 2019 and 2018, primarily from Cerus Europe B.V. operating profit - Income tax expense was **$0.1 million** for both the three months ended September 30, 2019 and 2018, and **$0.2 million** for both the nine months ended September 30, 2019 and 2018[103](index=103&type=chunk) - The tax expenses primarily resulted from the operating profit of the Cerus Europe B.V. subsidiary[103](index=103&type=chunk) - A valuation allowance is maintained on substantially all U.S. deferred tax assets due to cumulative operating losses[169](index=169&type=chunk) [Note 10. Development and License Agreements](index=19&type=section&id=Note%2010.%20Development%20and%20License%20Agreements) This note details key agreements, including the supply agreement with Fresenius for INTERCEPT components and the BARDA agreement for red blood cell development funding - The company has a Supply Agreement with Fresenius Kabi AG for the manufacture and supply of INTERCEPT Blood System disposable kits[104](index=104&type=chunk) - In August 2019, the company paid the remaining **€5.5 million** of Manufacturing and Development Payments to Fresenius[105](index=105&type=chunk) Payments to Fresenius for Product Manufacturing (in thousands) | Period | 2019 | 2018 | | :-------------------- | :----- | :----- | | Three Months Sep 30 | $9,800 | $5,600 | | Nine Months Sep 30 | $23,300 | $15,700 | - The five-year agreement with BARDA provides committed funding of up to **$103.2 million** for clinical development of the red blood cell system, with a total funding opportunity of **$201.2 million** if all options are exercised[110](index=110&type=chunk) - As of September 30, 2019, **$4.1 million** of billed and unbilled amounts related to BARDA were included in accounts receivable[112](index=112&type=chunk) [Note 11. Segment, Customer and Geographic Information](index=21&type=section&id=Note%2011.%20Segment%2C%20Customer%20and%20Geographic%20Information) The company operates in a single blood safety segment, with product revenues attributed geographically and significant customers - The company operates in only one segment: blood safety[113](index=113&type=chunk) Significant Customers' Contribution to Product Revenue | Customer | Three Months Sep 2019 | Three Months Sep 2018 | Nine Months Sep 2019 | Nine Months Sep 2018 | | :----------------------------- | :-------------------- | :-------------------- | :------------------- | :------------------- | | Établissement Français du Sang | 28% | 41% | 28% | 40% | | American Red Cross | 12% | <10% | 13% | <10% | [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=22&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses financial performance, operational highlights, revenue/expense trends, liquidity, capital resources, and critical accounting policies [Overview](index=23&type=section&id=Overview) The company focuses on the INTERCEPT Blood System; platelet and plasma systems are commercialized, while the red blood cell system is in development, with continued losses expected - The INTERCEPT Blood System for platelets and plasma are FDA approved and marketed globally, while the red blood cell system is in development with CE Mark application filed in December 2018, but regulatory approvals not expected before 2022[122](index=122&type=chunk)[124](index=124&type=chunk) - U.S. commercial efforts for platelet and plasma systems focus on implementation and awareness, with new FDA guidance requiring compliance with bacterial risk control strategies for platelets within 18 months[132](index=132&type=chunk) - The company expects to continue generating losses until widespread commercial adoption and positive net cash flows from operations are achieved[134](index=134&type=chunk

Financial Data and Key Metrics Changes - The company reported a record quarterly product revenue of $18.2 million for Q2 2019, an 18% increase from $15.4 million in Q2 2018 [26] - Year-to-date product revenue reached $35.7 million, up 23% compared to $29 million in the first half of 2018 [26] - Gross margins on product sales improved to 55% in Q2 2019 from 50% in Q2 2018, driven by economies of scale [34] - The net loss for Q2 2019 was $17.6 million, or $0.13 per diluted share, compared to a net loss of $13.3 million, or $0.10 per diluted share in the prior year [38] Business Line Data and Key Metrics Changes - INTERCEPT platelet kits accounted for approximately 90% of reported product revenue [31] - Global demand for INTERCEPT kits increased by 23% in Q2 2019 compared to the prior year, with a 40% increase in the number of treated platelet doses [29][30] - Government contract revenue for Q2 totaled $4.3 million, up from $4.0 million in the prior year [31] Market Data and Key Metrics Changes - The U.S. platelet market is concentrated, with the top five blood center networks distributing about 70% of the total platelet supply [16] - The American Red Cross is a significant customer, producing INTERCEPT at 17 sites, with 13 sites having BLA clearance [17] Company Strategy and Development Direction - The company raised its product revenue guidance for 2019 to a range of $72 million to $75 million, reflecting strong demand for INTERCEPT [8][33] - The company is focusing on expanding its product lines, including INTERCEPT plasma and pathogen-reduced cryoprecipitate, with anticipated market opportunities exceeding $200 million annually [44][47] - The company aims to double its product revenue base from existing product lines over four to five years, targeting a compound annual growth rate of 15% to 20% [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued adoption of pathogen reduction technology and its implications for global business growth [14] - The company anticipates increased engagement with major blood centers following the expected issuance of FDA guidance on bacterial safety [19][20] - Management acknowledged potential FX headwinds and seasonal impacts on revenue but remains optimistic about growth in the U.S. and EMEA markets [33][66] Other Important Information - The company ended Q2 with approximately $96.2 million in cash and short-term investments, utilizing a revolving line of credit to finance working capital [39] - The FDA has prioritized pathogen reduction technology, which is expected to influence regulatory approaches globally [14] Q&A Session Summary Question: Clarification on BLA clearance for American Red Cross sites - All manufacturing sites are receiving a BLA, with 17 sites currently manufacturing and 13 having a BLA while the other 4 are in process [49] Question: Timeline for red cell trials enrollment ramp-up - Enrollment is progressing well, with expectations for increased activity in the second half of the year [50][52] Question: Update on red blood cell review process in Europe - Qualifying a new GSH supplier is a priority, with expectations for completion by mid-next year, but timelines for CD Mark approval remain uncertain [54] Question: Distribution of revenue generation among U.S. blood centers - The American Red Cross is the largest customer, representing about 40% of the market, with the remaining centers at varying production levels [59] Question: Capacity to handle increased demand post-FDA guidance - The company is confident in its capacity to meet increased demand with additional capacity coming online in 2020 [60] Question: Next steps for INTERCEPT cryo submission and approval - Anticipated submission in the first half of 2020 with potential approval in the second half, expecting revenue contributions in 2020 [62] Question: Conversion of double dose kits in France - The current split is about 70-30 between double dose and single dose kits, with continued conversion expected [71] Question: Contributions from Germany - No contributions were seen in the quarter, but significant revenue is expected to start in 2020 [73]

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, 2019 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 (NASDAQ:CERS) Q1 2019 Earnings Conference Call May 7, 2019 4:30 PM ET Company Participants Tim Lee - Director, IR Obi Greenman - President & CEO Carol Moore - SVP, Regulatory Affairs & Quality Kevin Green - CFO Vivek Jayaraman - Chief Commercial Officer Conference Call Participants Sung Ji Nam - BTIG Drew Jones - Stephens Josh Jennings - Cowen Jordan Abrams - Cantor Fitzgerald Operator Good day ladies and gentlemen, and welcome to the Cerus Corporation First Quarter 2019 Earnings Conferenc ...

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, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to | --- | --- | |---------------------------------------------------------------------------------------|------------------------------------------------- ...

Cerus Corporation (NASDAQ:CERS) Q4 2018 Earnings Conference Call February 26, 2019 4:30 PM ET Company Participants Tim Lee - Investor Relations Director Obi Greenman - President and Chief Executive Officer Kevin Green - Chief Financial Officer Vivek Jayaraman - Chief Commercial Officer Laurence Corash - Chief Scientific Officer Carol Moore - Senior Vice President, Regulatory Affairs and Quality Conference Call Participants Catherine Schulte - Baird Mason Carrico - Stephens Josh Jennings - Cowen Jordan Abram ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------------|------------------------ ...