Cerus(CERS)
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Cerus(CERS) - 2020 Q3 - Earnings Call Presentation
2020-10-30 17:15
Q3 2020 Earnings Call & Business Update October 29, 2020 cerus © Forward Looking Statements The following presentation contains forward-looking statements concerning Cerus' products, prospects and expected results, including statements relating to Cerus' 2020 annual product revenue guidance, including Cerus' reasons for narrowing its 2020 annual product revenue guidance; Cerus' belief in its longer term growth opportunities, including its expectation of continued increase in INTERCEPT adoption beyond the Ma ...
Cerus(CERS) - 2020 Q3 - Earnings Call Transcript
2020-10-30 02:41
Cerus Corporation (NASDAQ:CERS) Q3 2020 Earnings Conference Call October 29, 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 Matthew Blackman - Stifel Mark Massaro - BTIG Jacob Johnson - Stephens Inc. Brandon Folkes - Cantor Fitzgerald Operator Ladies and gentlemen, thank you fo ...
Cerus(CERS) - 2020 Q3 - Quarterly Report
2020-10-29 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 o ...
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 ...