Sera Prognostics (SERA) FY Conference Transcript

Summary of Sera Prognostics Conference Call Company Overview - Company: Sera Prognostics - Industry: Healthcare, specifically focused on pregnancy and preterm birth risk assessment - Product: PreTRM Test, a clinically validated test for screening risks of spontaneous premature birth [2][3][4] Key Points and Arguments Challenges in Preterm Birth - Prevalence: 1 in 10 babies are born prematurely, defined as birth before 37 weeks of gestation [2][3] - Trends: Preterm birth rates in the U.S. have increased from 9.4% in 2013 to 10.4% in 2023, indicating a double-digit compound growth rate [5] - Healthcare Costs: Prematurity costs the U.S. healthcare system approximately $25 billion annually [4] - NICU Costs: Average NICU stay costs around $4,500 per day, with extremely premature babies costing up to $20,000 per day [6] PreTRM Test Overview - Unique Selling Proposition: The PreTRM Test is the only clinically validated test for early prediction of premature birth, utilizing proteomics to measure biomarkers [10][15] - Biomarkers: The test measures the ratio of IGFBP4 and SHBG proteins to assess risk for spontaneous preterm birth [10][11] - Timing: The test is conducted during weeks 18 to 20 of pregnancy, integrating into standard care [11] Clinical Validation and Efficacy - Clinical Studies: The PreTRM Test has been validated through studies like AVERT and PRIME, showing significant reductions in NICU admissions and improved neonatal health outcomes [16][19] - Efficiency: The number needed to screen to avoid one NICU admission is 40, compared to 150 for traditional methods [17] - Cost Savings: Only four women need to be screened to avoid one NICU day stay [20] Commercialization Strategy - Funding: Sera Prognostics is well-funded with approximately $110 million in cash and a $30 million annual operating budget [4] - Targeted States: The company is focusing on six key states for commercialization, with a sales force and access team to ensure reimbursement and awareness [21][22] - Partnerships: Collaborations with payers and digital education channels to increase awareness among clinicians and expectant mothers [23][25] Future Outlook - Guideline Inclusion: Aiming for inclusion in clinical guidelines and payer coverage based on clinical evidence [21] - Health Economic Model: The breakeven for deploying the test could be achieved within a year, presenting data at the ISPOR Europe Conference [24] - Community Impact: The goal is to empower mothers and educate providers to improve health outcomes for babies [25] Additional Important Information - Healthcare System Impact: The implications of preterm birth extend beyond immediate healthcare costs, affecting long-term health and economic outcomes for families [6][7] - Awareness Gap: Only 20% of expectant mothers are informed about the risks of preterm birth during their first appointment [9] - Technological Investment: Sera Prognostics is investing in AI and machine learning to enhance predictive algorithms for the PreTRM Test [13][14] This summary encapsulates the critical insights from the conference call, highlighting the challenges, solutions, and strategic direction of Sera Prognostics in addressing preterm birth risks.