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SERA PROGNOSTICS, INC. (SERA)·Q2 2024 Earnings Summary
Executive Summary
- Q2 2024 was a transitional execution quarter: revenue remained minimal while Sera advanced key prerequisites (AVERT publication, PRIME timeline, NY conditional approval for ambient whole‑blood kits) to support potential adoption and revenue inflection in 2025+ .
- Revenue was $0.02M and EPS was ($0.25); operating expenses fell 20% YoY as the company maintained tight cost control ahead of expected commercial expansion; net loss narrowed 21% YoY to $8.3M .
- Balance sheet remains strong with approximately $80.9M in cash, cash equivalents and marketable securities at 6/30/24; FY24 cash opex budget remains around $26M; runway “well into 2027.” S-3 shelf and an ATM with TD Cowen were established for flexibility .
- Catalysts and likely stock drivers: publication/presentation of PRIME full dataset (database lock targeted mid‑September; aim to publish in time for spring conferences), payer/guideline momentum, and commercialization of whole‑blood collection (COGS reductions, capacity) .
What Went Well and What Went Wrong
What Went Well
- Evidence milestone: AVERT PRETERM Trial published in Diagnostics (front cover), showing 18% reduction in severe neonatal morbidity/mortality, 7‑day reduction in mean hospital LOS for longest‑stay babies, +2.5 weeks gestational age and 28‑day NICU LOS reduction in <32‑week births; strong narrative for clinical and economic value .
- Commercial scalability: Conditional approval from New York State for the new ambient whole‑blood collection method; Sera began receiving commercial samples and processing them, improving access, margins, and capacity .
- Cost discipline and runway: Total opex down 20% YoY; net loss narrowed 21% YoY; cash, cash equivalents and marketable securities ~ $80.9M with cash opex budget ~ $26M and runway into 2027 .
What Went Wrong
- Revenue traction remains limited: Q2 revenue was $24K vs $123K YoY as the company deliberately focuses spend on prerequisites versus near‑term volume; sequential revenue remains de minimis .
- R&D spend ticked up: R&D rose ~19% YoY to $4.4M, driven by new product development; while strategic, it partially offset SG&A efficiencies .
- Estimate benchmarking: Wall Street consensus (S&P Global) was unavailable via our tool at analysis time, limiting vs‑estimate framing in this report (see Estimates Context).
Financial Results
Income Statement (selected)
Operating Expense Mix
Balance Sheet and Liquidity
Notes: Revenues are primarily from the PreTRM Test .
Estimates vs Actuals (Q2 2024)
- Consensus estimates from S&P Global were unavailable via our tool at analysis time; therefore, vs‑consensus comparisons are not presented (see Estimates Context).
Guidance Changes
Management did not issue formal revenue, margin, or EPS guidance for Q2/Q3; focus remains on evidence publication, market access, and cost discipline .
Earnings Call Themes & Trends
Management Commentary
- “Publication illustrated that our PreTRM test‑and‑treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length of stay.”
- “We’ve begun receiving commercial samples from [ambient whole‑blood] kits… benefits… improved physician and patient access… significantly lower cost of goods and significantly increased lab capacity.”
- “We… received conditional approval from the New York State for our PreTRM Test utilizing this new collection method… [now] offer… nationwide.”
- “As of June 30, 2024, the company had… approximately $80.9 million [in cash and marketable securities]… budgeted cash operating expenses of around $26 million in 2024… runway… well into 2027… filed an S‑3… and entered into an… ATM with TD Cowen.”
Q&A Highlights
- Payer reaction to AVERT: Positive, emphasizing NICU day savings; Sera notes only 3–4 expectant mothers need screening to save one NICU day, supporting swift payer ROI; more payer engagements planned in fall .
- Investments ahead of 2025: Building key account management, medical science liaisons, rev‑cycle/collections to support scale .
- PRIME publication process: Timing partially dependent on full dataset availability; aiming for spring conference submissions/publication once data locked; actively coordinating with journals .
- Pipeline economics: While PreTRM expected to be majority of revenue in ~3 years, management expects meaningful contributions from new products (e.g., Time‑to‑Birth) over time .
- Unit economics: New workflow expected to reduce COGS by ~35%–50%+, on top of already “really great margins” .
Estimates Context
- We attempted to retrieve S&P Global consensus for Q2 2024 revenue/EPS/EBITDA but were unable to access estimates via the tool at analysis time (request‑limit error). As a result, vs‑consensus comparisons are not presented. If needed, we can refresh once S&P Global access is available.
Key Takeaways for Investors
- Evidence stack strengthened: AVERT publication provides robust clinical and economic validation; PRIME full dataset and publication next—key catalysts for guideline adoption, payer coverage, and ordering behavior .
- Scalability unlocked: Ambient whole‑blood collection and lab workflow now commercial, with NY conditional approval; expected 35–50%+ COGS reduction and higher capacity position Sera for a 2025+ volume inflection .
- Prudent spend with runway: Opex down 20% YoY; cash/marketable securities ≈ $80.9M; FY24 cash opex ~ $26M; runway into 2027—enables disciplined execution without near‑term financing needs, while S‑3/ATM add flexibility .
- Near‑term prints likely remain light: Q2 revenue was $24K as the company prioritizes pre‑commercial prerequisites; focus remains on evidence, access, and awareness .
- Commercial readiness building: Deep HCP engagement (23.4% “deep engagement” across ~22k targets), upcoming TV campaigns, and payer economic models should support awareness and coverage discussions into year‑end .
- Watch for guideline and payer milestones: Any guideline statements and payer coverage wins could materially shift adoption and valuation narrative .
- Stock setup: High‑beta, catalyst‑driven path—results/publications (PRIME), guideline activity, and early commercialization uptake of whole‑blood collection are likely share‑movement triggers; ATM presence provides capital flexibility but could be an overhang depending on use .
Additional Documents Reviewed (Q2‑relevant)
- Q2 2024 8‑K (Item 2.02) with Exhibit 99.1 press release and full financial tables .
- Q2 2024 earnings call transcript (August 7, 2024) .
- July 9, 2024 AVERT publication press release .
- Q1 2024 press release and call (for sequential trend) .
Where we looked for prior two quarters: We included Q1 2024 (press release and transcript). Q4 2023 documents were not available in the archive we searched; if you’d like, we can supplement with 10‑K or other sources once provided.