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Cerus(CERS) - 2025 Q2 - Earnings Call Transcript
2025-08-05 21:30
Financial Data and Key Metrics Changes - The company reported product revenue of $52.4 million for Q2 2025, representing a 16% year-over-year increase [22][28] - For the first half of 2025, product revenue increased 15% to $95.7 million compared to the same period in 2024 [22] - Non-GAAP adjusted EBITDA for Q2 2025 was $935,000, marking the fifth consecutive quarter of positive adjusted EBITDA [28] Business Line Data and Key Metrics Changes - IFC revenue for Q2 2025 was $5.6 million, up from $2 million in the prior year period, with strong demand driving growth [24] - The core platelet franchise continues to be a key revenue driver, with increasing adoption of pathogen-reduced platelets in the U.S. and international markets [9][14] - The INT-two 100 illuminator was launched, receiving positive feedback and contributing to product growth [10][15] Market Data and Key Metrics Changes - North American product revenues increased 17% year-over-year in Q2 2025, while EMEA product revenues rose 21% [23] - Canadian Blood Services transitioned to 100% routine use of INTERCEPT platelets, and growth was noted in the Middle East [15] - The company is addressing regulatory requirements in China to strengthen its market position [16][17] Company Strategy and Development Direction - The company aims to transform blood safety and availability through its INTERCEPT product portfolio, with a focus on expanding its market presence [6][31] - The anticipated regulatory approval of the INTERCEPT red blood cell program in Europe is expected to enhance customer relationships [32] - The company is committed to achieving positive non-GAAP adjusted EBITDA for the full year 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in exceeding the full-year 2025 product revenue guidance due to strong customer demand [7][31] - The company remains mindful of macroeconomic and geopolitical factors but believes its value proposition and pipeline position it well for future growth [20] - The strong commercial results and product development progress indicate a sustainable growth trajectory [20][31] Other Important Information - The company received a $7.2 million award from the U.S. Defense Department for a study evaluating the utility of early IFC in trauma patients [12] - The company ended Q2 2025 with $78 million in cash and equivalents, slightly down from $80.5 million in the prior year [29] Q&A Session Summary Question: Revenue guidance for the year and expected cadence - Management expects continued growth in the back half of the year, with a flattening from Q2 to Q3 due to seasonal factors and deferred revenue recognized in Q2 [35][36] Question: EU red blood cell opportunity and TAM - The expanded CE Mark submission allows access to all patient populations, reducing initial limitations and opening up new opportunities [37][38] Question: Key drivers for IFC guidance and quarterly cadence - The strong pipeline of new hospital customers and increased supply position are expected to drive growth, despite some backlog being cleared in the first half [42][44] Question: Operating expenses and investment growth - The increase in operating expenses is primarily due to government contract activity and cost of living adjustments, with no significant one-time expenses [45]
Cerus(CERS) - 2025 Q2 - Quarterly Report
2025-08-05 20:52
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, 2025 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 (Exact name of registrant as specified in its charter) Delaware 68-0262011 (State or other jurisdiction ...
Cerus(CERS) - 2025 Q2 - Quarterly Results
2025-08-05 20:02
Exhibit 99.1 Cerus Corporation Announces Second Quarter 2025 Financial Results Second Quarter Total Revenue of $60.1 Million; Record Product Revenue of $52.4 Million, Up 16% Year-Over- Year Raising Full-Year 2025 Product Revenue Guidance Range to $200 Million - $203 Million Conference Call Today at 4:30 pm ET CONCORD, CA, August 5, 2025- Cerus Corporation (Nasdaq:CERS) announced financial results for the second quarter ended June 30, 2025, and provided a business update. Additional highlights include: • Sec ...
Cerus(CERS) - 2024 Q3 - Earnings Call Presentation
2025-07-09 13:11
Financial Performance & Guidance - Cerus is raising its full-year 2024 product revenue guidance to $177 - $179 million, anticipating a 12-14% increase compared to full-year 2023 product revenue[13] - The bottom end of the 2024 IFC guidance range has been raised to $9 - $10 million, from the prior $8 - $10 million[13] - In Q3 2024, Non-GAAP Adjusted EBITDA reached $4.4 million[32] Product & Market - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential growth to over $1.5 billion in 5-7 years[22] - The U S addressable market is $150 million, with potential growth to over $200 million in 5-7 years[22] - Cerus' preliminary 2023 product revenue was $156 million[22] Strategic Initiatives - Cerus has a new BARDA contract for INTERCEPT RBCs[11] - The company submitted a CE Mark for its LED Illuminator[11] - Cerus is focused on adjusted EBITDA and operating cash flow goals[25]
Cerus(CERS) - 2024 Q4 - Earnings Call Presentation
2025-07-09 13:11
Financial Performance & Outlook - Cerus achieved positive non-GAAP adjusted EBITDA for Q4 and full year 2024 [9] - The company anticipates product revenue growth of 8% to 11% year-over-year in 2025 [9] - Cerus is committed to sustaining positive adjusted EBITDA for fiscal year 2025 [9] - GAAP net loss attributable to Cerus improved by over 40% in 2024 compared to 2023 [9] - In 2024, Cerus achieved 15% topline growth due to strong team performance and blood center partnerships [10] Market & Product Expansion - Cerus is focused on the continued global expansion of its platelet franchise [9] - The company expects increasing uptake of INTERCEPT Fibrinogen Complex (IFC) in the US [9] - The global addressable market for INTERCEPT products is currently $1.3 billion and is expected to grow to over $1.5 billion in the next 5-7 years [16] - The U S addressable market is $150 million and is expected to grow to over $200 million in the next 5-7 years [16] Technology & Impact - Cumulative kit sales for over 16 million INTERCEPT treated doses of platelets & plasma [5]
Cerus (CERS) Earnings Call Presentation
2025-07-02 15:07
Financial Performance & Guidance - Cerus' annual product revenue has shown consistent growth from 2017 to 2022, with a compound annual growth rate (CAGR) of 30%[10] - In 2022, Cerus achieved product revenues of $162 million[33] - The company projects 2023 product revenue to be in the range of $165 million to $170 million[51] - Cerus anticipates reaching cash flow breakeven during 2023 and expects improvement across margins, cash flow, and operating expense leverage[3, 51] Market Opportunity & Growth Strategy - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential to grow to over $1.5 billion in the next 5-7 years[33] - The U S market represents a $150 million opportunity, expected to exceed $200 million in 5-7 years[33] - Cerus is focused on geographic expansion, including new markets like China, to extend its global reach[3, 53] Technology & Product - The INTERCEPT Blood System targets DNA and RNA to prevent pathogen proliferation in blood products[19, 20] - Over 10 million cumulative kits of INTERCEPT-treated blood products have been sold[40] - Cerus has an FDA-approved product for pathogen-reduced platelets in the U S [20, 58]
Cerus(CERS) - 2025 FY - Earnings Call Transcript
2025-06-11 13:40
Financial Data and Key Metrics Changes - The company achieved a positive non-GAAP adjusted EBITDA for 2024 and is committed to maintaining this for 2025, indicating an improving financial profile [7][42] - Current revenue guidance for 2025 is between $194 million to $200 million, representing a sub-10% penetration of the total addressable market (TAM) of $2.5 billion for existing licensed products [8][11] Business Line Data and Key Metrics Changes - The INTERCEPT Fibrinogen Complex product is projected to generate $12 million to $15 million in revenue for 2025, showing significant growth potential [11][31] - The INTERCEPT technology has been developed to treat all four transfused blood components: platelets, plasma, red cells, and fibrinogen complex, with a strong market presence in the platelet transfusion sector [4][5] Market Data and Key Metrics Changes - The total addressable market for the platelet opportunity is expected to reach at least $1.5 billion by 2030, with organic growth in the platelet market typically ranging from 3% to 5% annually [9][10] - The red cell market opportunity is the largest, estimated at $5 billion globally, highlighting the importance of getting the INTERCEPT Red Cell program approved [10] Company Strategy and Development Direction - The company aims to extend its leadership position in the INTERCEPT blood system for platelets and plasma, targeting additional market share in the U.S. and expanding into markets like China, Brazil, and Germany [42][43] - The focus is on developing real-world outcomes data for the INTERCEPT Fibrinogen Complex and targeting international opportunities [44] Management's Comments on Operating Environment and Future Outlook - Management emphasized the strong and improving financial profile, with sustained revenue growth expected through the end of the decade due to existing and new products [7][42] - The company is well-positioned to leverage its established customer base and recurring revenue model to drive growth [5][6] Other Important Information - The company has a strong cash position, which supports its growth initiatives and operational stability [7] - The INTERCEPT technology addresses significant unmet needs in transfusion medicine, particularly in pathogen reduction and safety [15][18] Q&A Session Summary Question: What is the outlook for the INTERCEPT Red Cell program? - The company is nearing completion of enrollment for the ReCePI study in the U.S., which is required for the PMA submission with the FDA [34] Question: How is the INTERCEPT Fibrinogen Complex performing in the market? - The product is gaining traction in major academic hospitals, with a projected revenue of $12 million to $15 million for 2025 and a significant market opportunity in the U.S. [31][32]
Cerus (CERS) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-01 22:05
Group 1 - Cerus reported a quarterly loss of $0.04 per share, better than the Zacks Consensus Estimate of a loss of $0.05, representing an earnings surprise of 20% [1] - The company posted revenues of $43.24 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 2.95%, and up from $38.37 million a year ago [2] - Cerus has surpassed consensus EPS estimates three times over the last four quarters [2] Group 2 - The stock has underperformed, losing about 14.3% since the beginning of the year, compared to the S&P 500's decline of 5.3% [3] - The current consensus EPS estimate for the coming quarter is -$0.02 on revenues of $49.5 million, and -$0.10 on revenues of $198 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Products is in the bottom 28% of over 250 Zacks industries, indicating potential challenges for stock performance [8]
Cerus(CERS) - 2025 Q1 - Earnings Call Transcript
2025-05-01 21:32
Financial Data and Key Metrics Changes - For Q1 2025, the company reported product revenue of $43.2 million, a 13% increase year-over-year, aligning with the guidance of 10% to 15% growth [21][22] - North American product revenues increased by 22% compared to the same period last year, driven by higher platelet sales and increasing demand for IFC [22][23] - First quarter product gross profit was $25.4 million, up from $21.3 million for the same period last year, representing a 20% increase [24] - The net loss attributable to the company was $7.7 million, or $0.04 per share, compared to a net loss of $9.7 million, or $0.05 per share, for the prior year period, indicating a 20% improvement [28] Business Line Data and Key Metrics Changes - The growth in product revenue was primarily led by robust North American platelet kit sales, with increasing demand in both the U.S. and Canada [18][22] - U.S. IFC sales totaled $3 million in Q1 2025, compared to $1.9 million in Q1 2024, reflecting strong customer demand [23] - EMEA product revenue declined by 4% year-over-year, with a 1% decline on a non-GAAP basis when excluding foreign exchange impacts [22] Market Data and Key Metrics Changes - The INTERCEPT system is now used in over 40 countries, with a significant presence in North America and Europe [8] - The company anticipates continued growth in international markets, particularly in regions with emerging demand for pathogen-reduced blood products [18][72] Company Strategy and Development Direction - The company aims to expand its platelet market share in the U.S. and improve IFC supply to meet growing customer demand [9][20] - The phased global launch of the INT200 device is expected to enhance the usability and efficiency of the system, supporting future geographic expansion [8][9] - The company remains focused on securing global regulatory approvals for its INTERCEPT product portfolio to improve blood safety and availability [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating geopolitical and macroeconomic uncertainties, emphasizing the compelling value proposition of INTERCEPT [16][17] - The company is optimistic about achieving positive non-GAAP adjusted EBITDA for the full year 2025, despite potential impacts from tariffs [29][30] - Management highlighted the importance of customer feedback and real-world experience in driving growth and validating the technology [72][75] Other Important Information - The company ended Q1 2025 with $80.9 million in cash and cash equivalents, a slight increase from $80.5 million at the end of 2024 [29] - Cash used from operations was minimal at $800,000, primarily tied to investments in working capital [30] Q&A Session Summary Question: Can you provide details on the 22% growth in North American product revenue in Q1? - Management noted that growth was driven by underlying demand in the U.S. franchise, with significant contributions from both platelet and IFC sales [35][38] Question: What are the next steps regarding the CE Mark application for the INTERCEPT red blood cell system? - Management indicated that TUV is conducting a clinical review, and they are optimistic about the application due to strong prior communications and a solid submission [43][45] Question: How is the EMEA business performing, particularly in France? - Management confirmed that the French platelet market remains stable, contributing positively to overall growth, with plans to initiate activity on the plasma side [48][50] Question: What are the plans to increase production capacity for IFC? - Management explained that several blood center production partners have received biologic license application approvals, allowing them to ramp up manufacturing to meet growing demand [51][53] Question: Can you discuss the assumptions in your guidance for the year? - Management clarified that the guidance includes anticipated revenue from the INT200 device and assumes a ramp-up in IFC production throughout the year [56][60]
Cerus(CERS) - 2025 Q1 - Quarterly Report
2025-05-01 21:06
Product Development and Regulatory Approvals - The INTERCEPT Blood System for red blood cells is currently in development and has not been commercialized anywhere in the world[122]. - The company received FDA approval for the INTERCEPT Blood System for Cryoprecipitation in November 2020, and it is being sold directly to hospitals and through blood centers[126]. - The ReCePI study, which evaluated the efficacy and safety of INTERCEPT-treated red blood cells, met its primary efficacy endpoint, demonstrating non-inferiority compared to conventional red blood cells[124]. - The company has two agreements with BARDA for funding to support the development of the red blood cell system, with the initial agreement expiring in September 2026 and a new agreement expiring in September 2030[125]. - The company plans to initiate a modular PMA application to the FDA upon anticipated completion of the RedeS clinical trial, which is expected in the second half of 2026[124]. - The company is facing challenges with the regulatory approval process for the red blood cell system, including a recent closure of its MDR application due to insufficient data[124]. - The company is required to obtain new PMAs for the INTERCEPT Blood System for Platelets and Plasma with the new LED-based illuminator[131]. Financial Performance - Product revenue for the three months ended March 31, 2025, was $43,239,000, representing a 13% increase from $38,365,000 in the same period of 2024[148]. - Government contract revenue increased to $5,614,000 for the three months ended March 31, 2025, up 12% from $5,030,000 in the prior year[148]. - Total revenue for the three months ended March 31, 2025, reached $48,853,000, a 13% increase compared to $43,395,000 in the same period of 2024[148]. - The increase in product revenue was primarily driven by year-over-year sales volume growth in disposable platelet kit sales to U.S. customers[149]. - The company expects continued growth in product revenue for INTERCEPT disposable kits due to increased market acceptance and adoption of the INTERCEPT Blood System[149]. - The company has a commitment from BARDA to reimburse up to $185.5 million for expenses related to the clinical development of the red blood cell system as of March 31, 2025[140]. - The 2024 BARDA Agreement includes committed funding of up to $32.1 million, with a total funding opportunity of $188.4 million if all options are exercised[142]. Costs and Expenses - Cost of product revenue increased by 4% to $17,815,000 for the three months ended March 31, 2025, compared to $17,093,000 for the same period in 2024[152]. - Gross margin on product sales improved to 59% in Q1 2025 from 55% in Q1 2024, driven by a favorable product mix and capitalization of inventoriable charges[153]. - Research and development expenses rose by 15% to $16,605,000 in Q1 2025, up from $14,482,000 in Q1 2024, mainly due to costs related to a new LED-based illuminator[156]. - Selling, general and administrative expenses increased by 2% to $20,286,000 in Q1 2025, compared to $19,799,000 in Q1 2024, primarily due to higher compensation costs[159]. Cash Flow and Working Capital - Net cash used in operating activities was $(844,000) for Q1 2025, a decrease from $1,959,000 provided in Q1 2024, attributed to increased inventory purchases[169]. - Net cash used in investing activities was $(1,189,000) in Q1 2025, compared to $1,446,000 provided in Q1 2024, primarily due to investment purchases[170]. - Working capital increased to $91,940,000 as of March 31, 2025, from $88,890,000 as of December 31, 2024, mainly due to higher inventory levels[172]. Risks and Financial Position - The company may need to curtail planned development or commercialization activities if unable to raise additional capital due to volatile global financial markets[129]. - The principal amounts under the Term Loan Credit Agreement will begin amortizing on April 1, 2026, which could negatively impact available working capital[128]. - The company expects to meet its capital requirements for at least the next 12 months through available cash, cash equivalents, and short-term investments, alongside revenue from product sales and government contracts[173]. - The company has the potential to borrow additional capital under existing credit agreements, which may include restrictive covenants that could impact operational flexibility[174]. - Funding from BARDA is subject to risks, including potential termination of agreements and the need to achieve specific milestones, which could significantly impact revenues and cash flows[179]. - The company does not currently hedge against foreign exchange fluctuations, which could materially affect future results[180]. - Economic uncertainties, including inflation and trade tensions, may limit the company's access to capital and negatively impact liquidity[181]. - Additional funding may be required to complete development activities for the red blood cell system, especially if costs exceed expectations or delays occur[182]. - The company has no off-balance sheet arrangements as of March 31, 2025, indicating a straightforward financial position[184]. Investment and Market Risk - The investment policy focuses on preserving principal and liquidity while maximizing returns, with no recorded credit losses during the three months ended March 31, 2025[185]. - There were no material changes to market risk disclosures during the three months ended March 31, 2025, indicating stability in risk management practices[186].