Sera Prognostics(US:SERA)2025-08-06 22:00Financial Data and Key Metrics Changes - Net revenue for the second quarter of fiscal year 2025 was $17 million, down from $24 million in the same quarter of 2024 [18] - Total operating expenses remained flat at $9.3 million compared to the previous year [18] - Research and development expenses decreased by approximately 24% to $3.3 million from $4.4 million due to lower clinical study costs [18] - Selling, general and administrative expenses increased to $6 million from $4.9 million as the company invests in targeted commercial activities [18] - Net loss for the quarter was $8 million, slightly improved from $8.3 million in the prior year [18] - As of June 30, 2025, the company had cash and cash equivalents of approximately $108.5 million, expected to fund operations through significant adoption and commercial milestones until 2028 [18] Business Line Data and Key Metrics Changes - The company is focusing on commercial strategies and tactics to enhance market awareness through data generation, particularly with the PRIME study results [5][6] - The company plans to publish additional data on health economic benefits and subpopulation analysis to support its reimbursement strategy [6][7] Market Data and Key Metrics Changes - The company is targeting Medicaid plan pilots in states with above-average premature birth rates, with hopes to sign two to four pilot programs in the coming months [9][10] - The company is also expanding its commercial reach in Europe, particularly in the UK, France, and Germany, where there is a recognized unmet need for preterm birth risk assessment [15][16] Company Strategy and Development Direction - The company aims to build market awareness and revenue through strategic partnerships and by enhancing its commercial team [12][13] - The transition of the preterm test from mass spectrometry to an immunoassay is part of the strategy to facilitate market entry in Europe [16][17] - The company is focused on generating evidence that meets regulatory standards for approval and reimbursement in Europe [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming publication of the PRIME study results and the potential impact on reimbursement strategies [6][25] - The company is actively engaging with healthcare provider organizations and opinion leaders to drive clinical utilization of its tests [9][10] - Management highlighted the importance of the upcoming medical conferences for sharing data and increasing awareness among clinicians [13][14] Other Important Information - The company has made key strategic leadership hires to enhance its commercial capabilities, including a new Chief Commercial Officer and head of market access [11][12] - The company plans to report on key commercialization performance indicators in the coming quarters [15] Q&A Session Summary Question: Can you discuss the milestones in your commercial efforts since adding Lee? - Management noted that Lee has emphasized the test's role in augmenting care protocols and has focused on expanding the commercial team with experienced sales leaders [22][23] Question: What is the rationale for expanding into the EU market? - Management explained that European opinion leaders encouraged the company to expand, and they plan to partner with local entities to minimize costs [29][30] Question: How many sales representatives have been hired, and how will Medicaid coverage affect hiring? - Management indicated that they currently have a 10% sales force and are prepared to hire more as reimbursement traction is achieved in targeted states [31][32] Question: Any updates on feedback regarding the ACOG bulletin? - Management highlighted the positive shift in ACOG's approach towards tailored care pathways, which aligns with the company's objectives [34][36]