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Sera Prognostics, Inc.
11/13/2025
afternoon and welcome to the Sarah Prognostics conference call to review third quarter fiscal year 2025 results. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would like to turn the call over to Jennifer Zibuda, Sarah's Head of Investor Relations, for a few introductory comments. Sarah, please go ahead.
Thank you, operator. Good afternoon, everyone. Welcome to Sarah Prognostics' third quarter fiscal year 2025 earnings conference call. At the close of market today, Sarah Prognostics released its financial results for the quarter ended September 30, 2025. Presenting for the company today will be Jenya Lingard, President and CEO, and Austin Ertz, our CFO. During the call, we will review the financial results we released today, after which we will host a question and answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at sarah.com. This call can be heard live via webcast at sarah.com, and a recording will be archived in the investors section of our website. Please note some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities. These statements are based on management's current expectations and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward-looking statements. I will now turn the call over to Jenya.
Thank you, Jennifer, and good afternoon, everyone. Building on the momentum from our prime study and ongoing commercialization efforts in the third quarter of 2025 marked continued progress in our transition toward preterm test adoption. We advanced our geographically focused strategy. In these regions, we are executing an integrated approach to achieving fair coverage, physician education, and patient awareness. We've continued to build visibility through key industry events and data presentations. Earlier this week, we presented health economics data at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Europe Conference. In October, Dr. Brian Erie delivered a compelling presentation of prime study outcomes at the inaugural Renaissance Conference, The Three Ages of the Woman, titled Dismantling the Preterm Barrier, biomarker-guided bundle care to improve neonatal outcomes. Links to both the poster and the presentation are now available in our press release issued today. We remain on track to publish the full results of our prime study in a peer-reviewed journal by the end of the year. We're very far along through the process of preparing a publication, and we look forward to sharing it with all stakeholders. What you can expect from us is a press release upon acceptance for publication, followed by an investor and analyst event with our principal investigators to discuss the strong primary outcomes we shared earlier this year, as well as some new and compelling data points from the study demonstrating the efficacy of the preterm test. Following prime, we plan to maintain a steady cadence of data publications and presentations focused on key topics including health economic benefits, population analysis, for example, first-time moms versus other moms, and Medicaid expected cost savings associated with SARA preterm tests. These data subsets will build on the robust evidence base already established by our prime and overt clinical studies. Together, They will not only reinforce the clinical and economic value of preterm, but also help support its adoption into standard prenatal care. Let's now shift to our commercial strategy and progress. And for those newer to our story, I'll start with a quick overview. Our sales and marketing efforts are concentrated in select regions where we see strong alignment across several factors. Headway with payer and Medicaid program discussions, support from influential local opinion leaders, engagement from early adopter institutions, and presence of prime study sites. By focusing on areas where these elements converge, we're creating conditions for meaningful clinical update of the preterm test. We've made real strides with Medicaid plan pilot programs, and our inaugural pilot in Nevada is actively enrolling patients. We're engaging payers, In our first wave of six target states, collectively representing a strong commercial opportunity covering approximately 33% of U.S. births and 35% of Medicaid births annually. Beyond this first wave, we've initiated outreach to the next tier of target states, expanding our footprint of states in discussion to 13 in total. We're also in discussions with organizations with regional and national reach across multiple lines of business. These early signals of market engagement give us confidence that we are well positioned to drive meaningful coverage and adoption in our target states and beyond. Our commercialization strategy is anchored in getting coverage first. It is built on a two-prong approach. First, targeting state engagement across first and second wave states, for example, Nevada, Texas, and Massachusetts. that have shown interest, face high preterm burdens, and have leveraged tools to adopt innovative programs in prenatal care. Second, payer-driven adoption through pilots and alignment to value-based care programs. By engaging state and payer leadership and connecting to the efforts of local institutions driving improvement in prenatal and maternal care quality outcomes, we're building a local flywheel of adoption that aims to accelerate provider buy-in and lays the groundwork for broader coverage. With Medicaid financing over 40% of 3.6 million U.S. births annually, the opportunity to drive meaningful cost savings and improve outcomes is substantial. We believe the preterm test offers a differentiated, data-driven solution for states seeking to reduce neonatal complications and manage Medicaid expenditures more efficiently. Our health economics data shows potential in-year savings from preterm tests screening of low-risk pregnancies. The path from initial state Medicaid director engagement to a state coverage decision takes time. Initially, we anticipate a cycle of about 24 months or more driven by the nature of prenatal testing and claims data availability. For example, the blood draw occurs between weeks 18 and 20 of pregnancy and followed by four to five months until delivery of babies and another three months or so for claims data to become available for analysis. Once the data is reviewed, we present the pilot results to the Medicaid plan and other state stakeholders to inform coverage decisions. As additional pilots launch, we will use the resulting data to demonstrate feasibility and build a strong business case for statewide coverage. Our commercialization strategy in the immediate term will focus on the target geography adoption wave by wave until guideline inclusion. Success of these efforts depends on achieving coverage in Medicaid and commercial plans, value-based care arrangements, and activating physician adoption and advocacy. Engagement with clinical leaders and alignment on target populations will be critical to securing guideline inclusion and accelerating adoption. Post-guidelines will scale nationally with a field sales force aiming for broader their coverage and expand national awareness building through traditional marketing channels. Although guideline inclusion is a long-term milestone, our focused efforts, both in evidence generation, KOL engagement, targeted state coverage, and physician adoption, are all needed to support it. Ultimately, the strategy positions us to drive meaningful revenue growth while improving outcomes for mothers and babies nationwide in helping address healthcare utilization trends, including rising costs associated with rising NICU admission rates, and longer hospital stays surrounding maternal and neonatal care. To provide clear visibility into our accelerating commercial execution, even at this early stage, we will begin sharing some key traction indicators, such as Medicaid pilot momentum, including number of live pilots, enrollment completion milestones, and expanding pipeline of states in discussions that will serve as tangible markers of progress as we build towards sustainable revenue growth. we're gaining meaningful traction across the payer landscape. We're actively engaging with 10 payers across 13 states, a diverse mix, both national and regional, Medicaid and commercial, who are focused on offering competitive healthcare benefits while managing rising costs. Our strategy targets forward-thinking organizations with strong member bases in key states where our sales reps are positioned well to maximize pull-throughs. We're also prioritizing institutions with value-based payment models, aligning incentives for providers and payers in preventing preterm birth complications. Prime and avert data strongly support a value-based approach and can accelerate preterm uptake where positive outcomes translate into payer, provider, and patient success. To recap our commercial progress, momentum is building. Our first Medicaid pilot is now live. We're in active dialogue with all six of our initial target states, and we've already begun engagement with the next wave of states, setting the stage for broader adoption and impact. To support our fundamental clinical and commercial efforts, we've made high-impact leadership appointments to the SARA team. As announced in October, Dr. Tiffany Inglis was appointed chief medical officer. An accomplished OBGYN with over 20 years of experience, including a decade in clinical practice and recent leadership at Elevance Health and CareLon Health, Dr. Inglis excels at driving women's health initiatives, payer coverage, and cost-effective outcomes. She will spearhead our medical affairs and strategy to accelerate preterm test adoption and establish it as a standard of care for preterm birth risk. In preparation for broader adoption of the preterm tests in our target states and beyond, we appointed Marisol Urbano as the head of commercial operations. With 20 years of healthcare experience and a proven track record in diagnostics, her leadership will be instrumental in accelerating customer onboarding and supporting clinical integration, key enablers of commercial traction during this foundational growth period. Complementing this leadership, we have successfully completed the hiring of sales representatives, across all six of our target states, and are well-positioned to expand market access and preterm utilization. Lastly, beyond our progress in the United States, we continue to explore Europe, a region that fully appreciates the pressing gap in preterm birth risk screening. We remain engaged in productive discussions with European regulatory bodies and are on track to submit our dossiers in early 2026. In closing, we've made significant strides in laying a strong foundation for adoption and reimbursement, setting the stage for future growth. Looking ahead, we're optimistic about the flywheel effect and these initiatives, which we believe will drive meaningful adoption and contribute to better maternal and neonatal outcomes. With that, I'll turn it over to Austin, our CFO, for a review of our financial results. Austin?
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