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Cerus(CERS) - 2022 Q4 - Annual Report
2023-02-28 16:00
60 See Note 7, Debt, in Part IV, Item 15, "Exhibits and Financial Statement Schedules" of this Annual Report on Form 10-K for more information on the debt under our Term Loan Credit Agreement and the Revolving Loan Credit Agreement. Critical Accounting Policies and Management Estimates Results of Operations Cost of Product Revenue Research and Development Expenses uncertainties associated with the successful completion of our research and development projects, which risks and uncertainties are discussed in ...
Cerus(CERS) - 2022 Q3 - Earnings Call Transcript
2022-11-03 21:50
Cerus Corporation (NASDAQ:CERS) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Jessica Hanover - Vice President, Corporate Affairs Obi Greenman - President and Chief Executive Officer Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Conference Call Participants Mathew Blackman - Stifel Brandon Folkes - Cantor Fitzgerald Operator Good day and thank you for standing by. Welcome to the Cerus Corporation’s Quarter Three 2022 Earnings Conference C ...
Cerus(CERS) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
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, 2022 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 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) ...
Cerus(CERS) - 2022 Q2 - Earnings Call Transcript
2022-08-04 22:31
Financial Data and Key Metrics Changes - Product revenues for Q2 2022 reached $41 million, reflecting a year-over-year growth of 30% [26] - Net loss attributable to Cerus for Q2 2022 was $8.4 million, a significant reduction from $15.4 million in the same period of 2021 [35] - Non-GAAP adjusted EBITDA improved to negative $2.4 million in Q2 2022, compared to negative $8.2 million in Q2 2021 [36] Business Line Data and Key Metrics Changes - North American product sales increased by 75% year-over-year, significantly contributing to overall revenue growth [18] - The calculated number of treatable platelet doses grew by 65% year-over-year in the U.S. and 22% internationally for Q2 2022 [29] - INTERCEPT disposable kits accounted for over 96% of Q2 product revenue [30] Market Data and Key Metrics Changes - EMEA region experienced positive growth despite currency headwinds, particularly in the Middle East [20] - The strengthening U.S. dollar posed a 6% headwind to top-line revenue for the quarter [57] Company Strategy and Development Direction - The company aims to make INTERCEPT the standard of care in transfusion medicine globally, with a focus on expanding patient access [10] - Plans to self-fund future growth as the company approaches cash flow breakeven [16] - Continued emphasis on building a strong body of evidence around INTERCEPT Fibrinogen Complex's utility [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit product revenue growth in the second half of 2022 despite economic headwinds [40] - The company reiterated its full-year 2022 product revenue guidance range of $160 million to $165 million, reflecting year-over-year growth of 22% to 26% [41] Other Important Information - The company is progressing with its INTERCEPT red blood cell efforts, with ongoing Phase III trials [42] - The review process for the European regulatory submission for INTERCEPT red blood cells has commenced [49] - Dr. Hua Shan was welcomed to the Board, bringing expertise in blood safety and pathogen reduction [54] Q&A Session Summary Question: What was the FX impact on the top line in the quarter? - The company experienced about a 6% headwind from FX for the quarter, with expectations of 3 to 4 million dollars in incremental FX impact for the back half of the year [57][58] Question: How should the third quarter be viewed in terms of seasonality? - Management indicated that while there are headwinds, underlying product growth remains robust, and they do not provide quarterly guidance [60][62] Question: What is resonating most in terms of uptake for IFC? - Early availability and lower wastage rates are key factors driving interest among clinicians [73][75] Question: What changes are expected to accelerate adoption of IFC? - The company aims to increase awareness through case studies and registry data, while overcoming staffing challenges in hospitals [78] Question: Are timelines for submitting INTERCEPT Platelets to the NMPA still intact? - The company remains on track for submission before the end of the year despite challenges from COVID lockdowns [81] Question: How is the inflationary environment impacting the business? - The company is managing price increases and does not foresee alarming impacts on reaching adjusted EBITDA neutrality [83]
Cerus(CERS) - 2022 Q2 - Quarterly Report
2022-08-03 16:00
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, 2022 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 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of t ...
Cerus(CERS) - 2022 Q1 - Earnings Call Transcript
2022-05-06 02:15
Financial Data and Key Metrics Changes - Product revenues for Q1 2022 reached $37.4 million, reflecting a year-over-year growth of 60% [25] - Gross profit for Q1 was $19.4 million, an increase of 58% year-over-year compared to $12.3 million in the prior year [29] - The net loss attributable to the company for Q1 2022 decreased to $12.3 million or $0.07 per diluted share, compared to $17.5 million or $0.10 per diluted share for the same period in 2021 [33] - The company raised its 2022 product revenue guidance from $157 million to $164 million to a new range of $160 million to $165 million, indicating a year-over-year growth of 22% to 26% [37] Business Line Data and Key Metrics Changes - Strong growth in the U.S. platelet business, which was up over 130% year-over-year [14] - The calculated number of treatable platelet doses in the U.S. increased by 141% year-over-year, while international growth was 28% [28] - Sales of INTERCEPT disposable kits represented nearly 98% of Q1 product revenue [28] Market Data and Key Metrics Changes - North America led sales growth with a 130% increase year-over-year, with Q1 revenue in North America nearly matching total global product revenue from Q1 2021 [26] - EMEA region saw an 11% year-over-year growth, and 19% growth when excluding negative foreign currency impacts [27] Company Strategy and Development Direction - The company is focused on establishing a new safety standard in transfusion medicine, expanding access to INTERCEPT treated blood components [10] - Plans to diversify growth with the nationwide launch of INTERCEPT Fibrinogen Complex (IFC) across the U.S. [15] - The company aims to increase manufacturing capacity to meet growing demand and improve cost profiles through new agreements [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for INTERCEPT products despite geopolitical and economic uncertainties [13] - The company is optimistic about the future growth trajectory, particularly with the anticipated increase in demand for Fibrinogen and the successful rollout of IFC [17][39] - Management highlighted the importance of the American Red Cross contract extension for future demand forecasting and operational planning [20][51] Other Important Information - The company reported a non-GAAP adjusted EBITDA of negative $3.7 million for Q1 2022, an improvement from negative $11.5 million in Q1 2021 [35] - Cash and cash equivalents at the end of Q1 2022 stood at $108.6 million, indicating a strong cash position [36] Q&A Session Summary Question: FX impact in Q1 and guidance adjustments - The FX impact for Q1 was approximately $1 million, with adjustments made in the new guidance to account for currency fluctuations [48] Question: Red Cross contract implications - The contract extension with the American Red Cross enhances demand management and operational planning, providing greater visibility for future growth [49][51] Question: International market opportunities - The company is pursuing opportunities in Canada and Germany, with expectations for progress in these markets over the next few years [61][62] Question: IFC launch timeline - The IFC product is expected to gain traction in 2023, with ongoing efforts to engage hospitals and clinicians [64][66]
Cerus(CERS) - 2022 Q1 - Quarterly Report
2022-05-04 16:00
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, 2022 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(CERS) - 2021 Q4 - Earnings Call Transcript
2022-02-23 01:00
Cerus Corporation (NASDAQ:CERS) Q4 2021 Results Conference Call February 22, 2022 4:30 PM ET Company Participants Matt Notarianni - Senior Director, IR Obi Greenman - President and CEO Kevin Green - CFO Carol Moore - SVP, Regulatory Affairs and Quality Jessica Hanover - VP, Corporate Affairs Conference Call Participants Josh Jennings - Cowen Jacob Johnson - Stephens Brandon Folkes - Cantor Fitzgerald Operator Good day, ladies and gentlemen. Thank you for standing by. And welcome to the Cerus Corporation Fou ...
Cerus(CERS) - 2021 Q4 - Annual Report
2022-02-21 16:00
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |---------------------------------------------------------------------|-------------------------------------------------------------------------------- ...
Cerus(CERS) - 2021 Q3 - Earnings Call Transcript
2021-11-03 02:09
Financial Data and Key Metrics Changes - Cerus Corporation reported record product revenue of $36.1 million for Q3 2021, representing a 53% year-over-year increase and a 15% sequential growth from Q2 2021 [18][25] - Year-to-date product revenues at the end of Q3 were only about $1 million shy of the full year 2020 product revenues, indicating strong growth momentum [26] - Gross profit for Q3 reached $18.5 million, the highest in the company's history, compared to $12.7 million in the prior year [30] - The net loss attributable to Cerus improved to $12.4 million, or $0.07 per diluted share, compared to a net loss of $14.1 million, or $0.08 per diluted share, in the prior year [37] Business Line Data and Key Metrics Changes - Product sales in North America grew 146% year-over-year, while EMEA sales grew 3% [19] - Sales to the top five US blood centers increased over 170% compared to Q3 2020, contributing significantly to overall revenue growth [20] - INTERCEPT platelet kits represented over 80% of total product sales, with cumulative kit sales recently surpassing 10 million doses globally [14][27] Market Data and Key Metrics Changes - The US platelet market is experiencing mid-single digit organic growth, creating demand for efficient supply chain solutions [51] - The INTERCEPT blood system is becoming the standard of care in the US platelet market, with INTERCEPT treated platelets now representing the majority of platelets produced [12][62] Company Strategy and Development Direction - The company aims to establish the INTERCEPT blood system as the global standard of care in transfusion medicine, focusing on expanding its market presence and product adoption [15][47] - Cerus is committed to advancing its pipeline, with several important product launches anticipated in the coming years [47] - The company plans to strip out government contract revenue and expenses from its financial metrics to highlight core business performance [29] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about continued growth in 2022, driven by the size of the market and the increasing adoption of INTERCEPT products [51] - The company is focused on achieving cash flow breakeven while investing in growth for both the short and long term [38] - The ongoing blood supply shortage in the US is a concern, but it is not expected to significantly impact Cerus's immediate growth trajectory [59] Other Important Information - The company has signed a multiyear contract extension with EFS, France's national transfusion service, validating its business model and commitment to blood safety [46] - The INTERCEPT Fibrinogen Complex (IFC) product has seen initial commercial sales, with plans for a nationwide rollout pending regulatory approvals [21][24] Q&A Session Summary Question: What is the sustainable growth trajectory for Cerus going into 2022 and 2023? - Management expressed confidence in sustaining growth domestically and internationally, citing strong demand from blood centers and hospitals for INTERCEPT treated platelets [50][52] Question: Can you provide updates on the INTERCEPT Fibrinogen Complex and its market potential? - The total addressable market for IFC is estimated at $300 million in the US, with growth driven by increased use of fibrinogen concentrates in surgical procedures [53][54] Question: How is the company addressing the blood shortage in the US? - Management noted that the blood shortage continues but does not significantly impact Cerus's growth trajectory, emphasizing the need for increased platelet supply [59] Question: What are the expectations for gross margins moving forward? - Gross margins are expected to remain stable in the near term, with potential for expansion as the company increases production efficiency and shifts to double dose kits [60][72] Question: What is the status of the red blood cell studies and expected launch timelines? - Enrollment for the Phase III studies is ongoing, with updates expected in the first half of 2022, while a product launch in Europe is anticipated in 2023 [77][78]