Strata Critical Medical (NasdaqCM:BLDE) 2025 Investor Day November 17, 2025 02:00 PM ET Company ParticipantsKeith Trepanero - Chief Safety OfficerAndrew Murrill - Director of Business DevelopmentScott Silvestri - Organ Recovery and Service Line Champion and Medical DirectorMatt Schneider - VP of Finance and Investor Relations and CFO of Clinical ServicesScott Wunsch - CEO of LogisticsJustin Wang - Equity Research AssociateEric Moore - VP of Software Development and EngineeringChristie Campbell - VP of Clini ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $157.4 million, representing approximately 38% year-over-year growth and about 10% sequential growth from Q1 2025 [10] - Operating profit for Q2 was approximately $36.6 million, representing more than 23% of total revenue, up from $27.4 million or 19% of total revenue in Q1 2025 [12] - Net income for Q2 was $35 million, representing a 186% year-over-year increase and 36% sequentially [43] - The company ended Q2 with over $400 million in cash, an increase of approximately $90 million from Q1 2025 [12][43] Business Line Data and Key Metrics Changes - U.S. transplant revenue was approximately $152 million, up 40% year-over-year and 10% sequentially, with liver contributing $116 million, heart $32 million, and lung $4 million [39] - Product revenue for Q2 reached $96 million, up 34% year-over-year and 9% sequentially, driven by increasing organ utilization in liver and OCS adoption across both liver and heart [40] - Service revenue for Q2 reached $61 million, up 44% year-over-year and 11% sequentially, primarily driven by logistics revenue, which grew 56% year-over-year and 14% sequentially [40] Market Data and Key Metrics Changes - OCS Lung experienced approximately 14% sequential growth in Q2 [11] - The company covered 79% of its NOP missions requiring air transport in Q2, nearly reaching its target of 80% to 85% [15] Company Strategy and Development Direction - The company aims to grow OCS NOP volumes beyond the planned 10,000 for 2028 and is exploring options for international expansion, particularly in Europe [13][14] - The company is focused on expanding its infrastructure footprint, delivering on its OCS platform pipeline, and capitalizing on national modernization initiatives [32][34] - The company plans to invest in R&D to advance its pipeline and improve operational efficiencies [45][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving and surpassing the target of 10,000 U.S. NOP transplants by 2028, with plans to exceed that in subsequent years [13] - The company raised its full-year 2025 revenue guidance to between $585 million and $605 million, reflecting approximately 35% growth over 2024 at the midpoint [36][44] - Management acknowledged the potential for seasonality in Q3 but expects a strong finish to the year [35][36] Other Important Information - The company received FDA conditional approval for the OCS Lung IDE in July and is close to reaching an agreement for the OCS Heart IDE [16] - Management emphasized the importance of transparency and collaboration with stakeholders in the U.S. transplant ecosystem [27][28] Q&A Session Summary Question: What are the signs of seasonality observed in July? - Management noted some signs of seasonality in July, but the impact appears slightly less than last year, and it is still early to establish a trend [54] Question: Concerns about oversight over OPOs and DCD usage? - Management believes that increased oversight could benefit the transplant market, especially in DCD, and sees it as an opportunity rather than a concern [56][58] Question: Updates on the lung trial and any changes in design? - Management confirmed that there were no substantive changes to the clinical trial design as agreed with the FDA [60] Question: Thoughts on the U.S. heart market and its growth? - Management indicated that the heart market has experienced fluctuations but expects normalization with the introduction of next-gen technology [64] Question: Any headwinds anticipated as the U.S. transplant network evolves? - Management does not foresee headwinds, citing clear data supporting the success of their NOP and OCS initiatives [71][72] Question: Status of DCD donations and utilization? - Management reported that DCD donation remains stable and is an essential part of the organ transplantation renaissance [85] Question: Revenue generation from the cold storage arm of the clinical trials? - Management indicated that there may be some revenue generated from logistics in the control arm, but specifics will be clarified once the trial starts [91]

Core Points - The investigation by the U.S. Department of Health and Human Services (HHS) revealed that some organ procurement organizations began organ harvesting activities while patients were still alive, raising ethical concerns about organ transplantation [1][3] - The HHS investigation reviewed 351 cases of authorized but incomplete organ donations, finding that in Kentucky, 73 patients exhibited neurological signs inconsistent with organ donation, and at least 28 patients may not have been deceased when procurement procedures were initiated [1][3] - HHS Secretary Xavier Becerra emphasized the need for accountability among organ procurement organizations and called for systemic reforms to ensure respect for potential donors' lives [3] Investigation Findings - The investigation uncovered insufficient neurological assessments of organ donors, issues with informed consent procedures, and misclassification of causes of death in several cases [3] - The "Network for Hope," a federally funded organ procurement organization serving parts of Kentucky, Ohio, and West Virginia, has been mandated to implement corrective measures or risk losing its certification [3] Ethical Concerns - The incident has reignited debates over organ donation standards, particularly regarding the timing of organ removal after cardiac arrest, as brain activity may not cease immediately [4] - Experts highlight that it typically takes over four minutes for brain neurons to die completely after cardiac arrest, complicating the organ removal timeline [4] Standards and Practices - The director of NYU Langone Transplant Institute stated that their hospital adheres to strict protocols, requiring a five-minute wait after declaring circulatory death before organ removal [5] - In contrast, a domestic transplant expert noted that organ transplantation in China requires meeting both brain death and circulatory death criteria, with brain death being a necessary condition [6]