Sera Prognostics (SERA) 2025 Conference Transcript

Summary of Sera Prognostics (SERA) 2025 Conference Call Company Overview - Company: Sera Prognostics (SERA) - Industry: Diagnostics, specifically focused on preterm birth prediction Key Points and Arguments Preterm Birth Prediction - Current methods for predicting preterm births are limited, primarily relying on previous preterm births and short cervix, which only applies to a small percentage of mothers [1][2] - Approximately 3.6 million mothers give birth annually, with a significant portion being first-time mothers who lack identifiable risk factors for preterm birth [1] Test Approval and Regulation - The preterm test is classified as a lab-developed test (LDT) and is overseen by CAP and CLIA, not the FDA [4] - There is no current risk to commercialization despite potential future FDA oversight of LDTs [6][7] Reimbursement Strategy - Sera Prognostics has partnered with national payer Elevance to facilitate reimbursement, which is expected to expedite coverage compared to typical timelines for diagnostic companies [9][10] - The company has a Medicare code for the test priced at $750, with expectations for both commercial and Medicaid plans to provide coverage [14][10] Market Opportunity - The total addressable market (TAM) for the test is estimated at approximately 3.2 million women annually, representing a multibillion-dollar opportunity [16] - The company plans to target specific states with high rates of preterm births to drive adoption [18] Economic Impact - The test has demonstrated significant cost savings, with estimates showing that screening three to four mothers can save one NICU day, which costs between$4,500 and $20,000 [34][35] - The overall economic burden of preterm births in the U.S. is over$25 billion, with childbirth-related costs representing 27% of all inpatient costs in Medicaid [36] Clinical Utility and Data Collection - The PRIME study showed that the test could keep one out of five babies out of the NICU, generating excitement in the clinical community [31][39] - Sera Prognostics is collecting extensive data on pregnancy-related proteins, with plans to develop additional women's health products [29][30] Sales and Marketing Strategy - The company is expanding its sales force and has appointed a new Chief Commercial Officer to enhance its market presence [22] - Initial efforts will focus on three to five states with high preterm birth rates, leveraging relationships with key opinion leaders and payers [18] Financial Position - Sera Prognostics has raised $57 million, bringing total funding to$215 million, providing a runway until the end of 2028 to reach profitability [23][24] - The annual cash burn rate is between $25 million and$30 million, allowing for strategic growth and marketing efforts [24] Future Catalysts - Upcoming publications detailing the test's efficacy and economic impact are anticipated, along with traction with Medicaid plans [41][42] - The company aims to provide revenue guidance for fiscal 2026 as it gains visibility on volume and market uptake [43] Additional Important Insights - The test's pricing strategy is designed to ensure broad adoption, especially in light of potential Medicaid budget cuts [38] - The clinical community is eager for innovations that can significantly impact preterm birth outcomes, highlighting the test's potential to transform care [39][40]