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Cerus(CERS) - 2020 Q2 - Earnings Call Transcript
2020-08-05 02:47
Financial Data and Key Metrics Changes - The company reported record product revenue of $21.5 million for Q2 2020, an 18% increase from $18.2 million in Q2 2019 [9][42] - Year-to-date product revenue reached $40.1 million, up 12% from $35.7 million in the first half of 2019 [42] - The net loss for Q2 2020 was $14.9 million, or $0.09 per diluted share, compared to a net loss of $17.6 million, or $0.13 per diluted share in the prior year [52] - The company ended Q2 2020 with approximately $136.5 million in cash, cash equivalents, and short-term investments [53] Business Line Data and Key Metrics Changes - Platelet kit sales in the U.S. showed robust year-over-year growth, accounting for approximately 82% of total kit sales, while plasma sales accounted for about 18% [12][45] - Government contract revenue from BARDA collaboration totaled $5.3 million in Q2 2020, compared to $4.3 million in the prior year [46] Market Data and Key Metrics Changes - The overall market opportunity for INTERCEPT platelets in the U.S. is approximately $150 million per year [17] - The American Red Cross has approximately 25% of their platelets now being INTERCEPT treated, with 20 of 23 production sites producing INTERCEPT platelets [13][16] Company Strategy and Development Direction - The company aims to capture as much of the U.S. INTERCEPT platelet market opportunity as possible over the next few years, with a goal for INTERCEPT to become the Standard of Care for platelets [17] - A five-year contract with the Hong Kong Red Cross was announced, representing a strategic account for expanding presence in the Asia-Pacific region [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving product revenue guidance of $89 million to $93 million for the year despite ongoing COVID-19 challenges [22] - The company is focused on ensuring support for blood center customers while preparing for two key product launches [60] Other Important Information - The company is on track for a PMA submission for pathogen-reduced cryoprecipitated fibrinogen complex by the end of the year, with potential FDA approval expected in early 2021 [25][26] - The INTERCEPT red blood cell program is progressing, with CE Mark approval expected in 2022 [40] Q&A Session Summary Question: What was the INTERCEPT platelet mix at the Red Cross at the end of 2019? - Management indicated that the American Red Cross has been steadily increasing their INTERCEPT platelet mix, with significant progress noted [61] Question: Is the seven-day U.S. platelet label just a label change? - Management confirmed that it is primarily a label change, which could enhance operational efficiency and justify a premium price for INTERCEPT [63][64] Question: What is the opportunity in Asia Pacific following the Hong Kong contract? - Management highlighted the importance of the Hong Kong Red Cross as a key opinion leader in the Asia-Pacific region, providing a critical entry point for further expansion [68][70] Question: Has the pace of INTERCEPT adoption changed with the FDA guidance deadline approaching? - Management noted that while there have been challenges due to COVID-19, there is a methodical move towards compliance with the FDA guidance, indicating solid growth in the U.S. platelet business [72]
Cerus(CERS) - 2020 Q2 - Quarterly Report
2020-08-04 22:20
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, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 19 ...
Cerus(CERS) - 2020 Q1 - Earnings Call Transcript
2020-05-06 02:56
Cerus Corporation (NASDAQ:CERS) Q1 2020 Earnings Conference Call April 5, 2020 4:30 PM ET Company Participants Tim Lee - Investor Relations Obi Greenman - President and Chief Executive Officer Kevin Green - Chief Financial Officer Vivek Jayaraman - Chief Operating Officer Carol Moore - SVP of Regulatory Affairs and Quality Conference Call Participants Mathew Blackman - Stifel Josh Jennings - Cowen and Company, LLC Jacob Johnson - Stephens Inc. Operator Ladies and gentlemen, thank you for standing by and wel ...
Cerus(CERS) - 2020 Q1 - Quarterly Report
2020-05-05 21:28
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, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1 ...
Cerus(CERS) - 2019 Q4 - Annual Report
2020-02-21 21:20
PART I [Business](index=4&type=section&id=Item%201.%20Business) Cerus Corporation develops and commercializes the INTERCEPT Blood System for blood safety, with platelet and plasma systems commercialized and red blood cell system in late-stage development - The company's core focus is the development and commercialization of the **INTERCEPT Blood System** to reduce blood-borne pathogens in donated blood components[11](index=11&type=chunk) Product Development Status | Product System | Status | | :--- | :--- | | **Platelets & Plasma** | Commercialized in the U.S., Europe, CIS, Middle East, and other regions. Received FDA approval and CE Marks. Refiling for CE Mark under new Medical Device Regulation (MDR) is planned | | **Red Blood Cells** | Currently in development. Two Phase 3 clinical trials (RedeS and ReCePI) are ongoing in the U.S. European Phase 3 trials are complete, but CE Mark approval under the new MDR is not expected until 2022 | - Manufacturing is outsourced to third parties, with a **sole-source reliance on Fresenius Kabi AG** for disposable kits for the platelet and plasma systems[38](index=38&type=chunk) - The market is highly concentrated, with key customers including the **American Red Cross** in the U.S. and national blood services like **Établissement Français du Sang (EFS)** in France[46](index=46&type=chunk)[50](index=50&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including dependence on INTERCEPT Blood System commercial success, low market adoption, financial losses, extensive regulation, and BARDA funding dependency - The company's business is substantially dependent on its ability to successfully commercialize the **INTERCEPT Blood System** for platelets and plasma in the U.S. market[100](index=100&type=chunk) - Broad market adoption is not guaranteed and is affected by factors such as cost, perceived efficacy, operational integration challenges for blood centers, and competition from alternative technologies[107](index=107&type=chunk)[108](index=108&type=chunk)[114](index=114&type=chunk) - The company has a history of **substantial losses** and expects losses to continue due to high R&D and SG&A expenses, with profitability dependent on widespread commercial adoption which may not occur[123](index=123&type=chunk) - Cerus and its products are subject to **extensive and rigorous regulation** by the FDA and foreign authorities, with the red blood cell system requiring significant additional testing and development before potential approval[132](index=132&type=chunk)[143](index=143&type=chunk) - A significant portion of funding for the red blood cell system's development comes from a **BARDA agreement**, which can be reduced, delayed, or terminated, posing a risk to the program's continuation[165](index=165&type=chunk) - The company relies on a complex manufacturing supply chain with a number of third-party suppliers, many of whom are **sole suppliers** for specific components, exposing Cerus to significant supply chain risks[194](index=194&type=chunk)[195](index=195&type=chunk) [Unresolved Staff Comments](index=53&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - There are **no unresolved staff comments**[290](index=290&type=chunk) [Properties](index=53&type=section&id=Item%202.%20Properties) Cerus Corporation's headquarters and R&D are in a leased 84,631 sq ft facility in Concord, California, with a European office in Amersfoort - The main corporate headquarters and R&D facility is an **84,631 sq. ft. leased space** in Concord, California[291](index=291&type=chunk) - A separate leased facility in Amersfoort, the Netherlands, supports European sales and administration[291](index=291&type=chunk) [Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no legal proceedings to disclose for the period - The company has **no legal proceedings** to report[292](index=292&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[293](index=293&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=54&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Cerus Corporation's common stock trades on Nasdaq under CERS, with no dividends paid or planned, and a 5-year performance graph provided - The company's common stock trades on the **Nasdaq Global Market** under the ticker **CERS**[295](index=295&type=chunk) - Cerus has **not paid dividends** and does not plan to in the foreseeable future[297](index=297&type=chunk) 5-Year Cumulative Total Return on Investment ($100) | Year | Cerus Corporation | Nasdaq Biotech Index | Nasdaq Index | | :--- | :--- | :--- | :--- | | **2014** | $100.00 | $100.00 | $100.00 | | **2015** | $101.28 | $111.42 | $105.73 | | **2016** | $69.71 | $87.26 | $113.66 | | **2017** | $54.17 | $105.64 | $145.76 | | **2018** | $81.25 | $95.79 | $140.10 | | **2019** | $67.63 | $119.17 | $189.45 | [Selected Financial Data](index=55&type=section&id=Item%206.%20Selected%20Financial%20Data) This section summarizes five years of financial data (2015-2019), showing consistent product revenue growth, increasing government contract revenue, and annual net losses Selected Consolidated Statements of Operations Data (in thousands) | Metric | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | **Product revenue** | $74,649 | $60,908 | $43,568 | $37,183 | $34,223 | | **Government contract revenue** | $19,125 | $15,143 | $7,758 | $2,092 | $— | | **Loss from operations** | $(66,226) | $(54,988) | $(57,530) | $(61,447) | $(61,075) | | **Net loss** | $(71,244) | $(57,564) | $(60,585) | $(62,906) | $(55,868) | | **Net loss per share (Basic)** | $(0.51) | $(0.44) | $(0.56) | $(0.62) | $(0.58) | Selected Consolidated Balance Sheets Data (in thousands) | Metric | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | **Cash, cash equivalents and short-term investments** | $85,718 | $117,577 | $60,696 | $71,628 | $107,879 | | **Working capital** | $77,772 | $94,224 | $66,767 | $67,217 | $108,544 | | **Total assets** | $165,535 | $163,460 | $98,244 | $103,476 | $139,402 | | **Total stockholders' equity** | $57,052 | $84,519 | $38,940 | $57,787 | $94,765 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=56&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses 2019 financial performance, noting a 23% total revenue increase, significant R&D and SG&A expense rises, a $71.2 million net loss, and reliance on future financing and BARDA funding Revenue Performance (2017-2019) | Revenue Source | 2019 | 2018 | 2017 | % Change (2019 vs 2018) | | :--- | :--- | :--- | :--- | :--- | | **Product revenue** | $74,649 | $60,908 | $43,568 | 23% | | **Government contract revenue** | $19,125 | $15,143 | $7,758 | 26% | | **Total revenue** | $93,774 | $76,051 | $51,326 | 23% | - The **2019 product revenue increase** was primarily due to sales volume growth of disposable kits in the U.S. and the Middle East[336](index=336&type=chunk)[337](index=337&type=chunk) - Research and development expenses increased by **42% in 2019 to $60.4 million**, driven by product enhancements, BARDA-related activities, and development for extended-storage cryoprecipitate[350](index=350&type=chunk) - Selling, general, and administrative expenses increased by **16% in 2019 to $66.2 million**, due to higher stock compensation and investments in supply chain and commercial launch preparations[354](index=354&type=chunk) - Net cash used in operating activities increased to **$65.8 million in 2019** from $31.2 million in 2018, mainly due to higher operating expenditures and a one-time **$6.1 million payment to Fresenius**[370](index=370&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=67&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rates and foreign currency, with hypothetical increases impacting 2019 net interest expense by $0.4 million and foreign exchange by $1.0 million - The company's primary market risks are **interest rate risk** and **foreign currency risk**[390](index=390&type=chunk)[393](index=393&type=chunk) - A hypothetical **100 basis point increase** in interest rates would have increased 2019 net interest expense by approximately **$0.4 million** due to variable-rate debt[392](index=392&type=chunk) - A hypothetical **10% unfavorable change** in foreign currency exchange rates at year-end 2019 would have negatively impacted annual financial results by **$1.0 million**, as many international sales are denominated in Euros[394](index=394&type=chunk) [Financial Statements and Supplementary Data](index=67&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section indicates consolidated financial statements, notes, and the independent auditor's report are included in Item 15(a) - The consolidated financial statements and the independent auditor's report are located in **Item 15(a)** of the Form 10-K[395](index=395&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=67&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None reported[395](index=395&type=chunk) [Controls and Procedures](index=68&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2019, with an unqualified auditor opinion - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2019[397](index=397&type=chunk) - Management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2019[400](index=400&type=chunk) - The independent auditor, Ernst & Young LLP, issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of December 31, 2019[401](index=401&type=chunk)[405](index=405&type=chunk) [Other Information](index=70&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[412](index=412&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accountant Fees](index=71&type=section&id=Items%2010-14) Information for Items 10 through 14, covering directors, executive officers, corporate governance, executive compensation, security ownership, related transactions, and principal accountant fees, is incorporated by reference from the 2020 proxy statement - Information for **Items 10, 11, 12, 13, and 14** is incorporated by reference from the company's **2020 Proxy Statement**[414](index=414&type=chunk)[415](index=415&type=chunk)[418](index=418&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics**, which is available on its website[416](index=416&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=72&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section contains the company's consolidated financial statements for the fiscal year ended December 31, 2019, the independent auditor's report, and a comprehensive list of filed exhibits - This section includes the **audited consolidated financial statements** for the three years ended December 31, 2019, and the independent auditor's report[424](index=424&type=chunk)[461](index=461&type=chunk) - A comprehensive list of exhibits filed with the report is provided, including material agreements related to manufacturing, supply, and financing[430](index=430&type=chunk)[431](index=431&type=chunk)[434](index=434&type=chunk) 2019 Key Financial Statement Balances (in thousands) | Account | Amount | | :--- | :--- | | **Total Assets** | $165,535 | | **Total Liabilities** | $108,483 | | **Total Stockholders' Equity** | $57,052 | | **Total Revenue** | $93,774 | | **Net Loss** | $(71,244) | [Form 10-K Summary](index=77&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that there is no Form 10-K summary provided - None[458](index=458&type=chunk)
Cerus(CERS) - 2019 Q4 - Earnings Call Transcript
2020-02-21 03:03
Cerus Corporation (NASDAQ:CERS) Q4 2019 Earnings Conference Call February 20, 2020 4:30 PM ET Company Participants Tim Lee - Investor Relations Obi Greenman - President and Chief Executive Officer Kevin Green - Chief Financial Officer Carol Moore - SVP of Regulatory Affairs and Quality Conference Call Participants Mathew Blackman - Stifel Jacobs Johnson - Stephens Operator Ladies and gentlemen, thank you for standing by and welcome to the Cerus Corporation Fourth Quarter and Full Year 2019 Earnings Conferen ...
Cerus(CERS) - 2019 Q3 - Earnings Call Transcript
2019-10-31 02:54
Cerus Corporation (NASDAQ:CERS) Q3 2019 Earnings Conference Call October 30, 2019 4:30 PM ET Company Participants Tim Lee – Investor Relations Obi Greenman – President and Chief Executive Officer Laurence Corash – Co-Founder and Chief Scientific Officer Vivek Jayaraman – Chief Commercial Officer Kevin Green – Chief Financial Officer Conference Call Participants Craig Bijou – Cantor Fitzgerald Mathew Blackman – Stifel Catherine Schulte – Baird Jacob Johnson – Stephens Operator Good afternoon, ladies and gent ...
Cerus(CERS) - 2019 Q3 - Quarterly Report
2019-10-30 21:24
[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
Cerus(CERS) - 2019 Q2 - Earnings Call Transcript
2019-08-02 01:51
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]
Cerus(CERS) - 2019 Q2 - Quarterly Report
2019-08-01 21:11
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 | --- | --- | --- | |-----------------------------------------------------|--------------------------------------------- ...