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SERA PROGNOSTICS, INC. (SERA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results remained de minimis on revenue as Sera continues to prioritize evidence-generation and commercialization groundwork: revenue $0.024M, net loss $8.6M, EPS $(0.25) . EPS modestly missed consensus by $0.01 while revenue trivially exceeded a near-zero consensus estimate (thin coverage) . Q4 2024 consensus: EPS $(0.24), revenue $0.
  • PRIME outcomes presented in Jan 2025 showed meaningful clinical impact (25% reduction in NMI; 18% reduction in neonatal length of stay in the modified ITT population), strengthening the case for payer engagement and future guideline consideration .
  • Liquidity improved with a $57.5M follow-on in Feb 2025; runway guided “into 2028,” enabling a step-up in 2025 commercial investments (cash OpEx guidance $30–$35M) to drive adoption, Medicaid pilots, and EU immunoassay development .
  • Near-term stock catalysts: peer‑reviewed PRIME publication; initial Medicaid/state partnerships; early commercialization signals in targeted geographies; progress on EU immunoassay and Time‑to‑Birth/predictive analytics product rollouts .

What Went Well and What Went Wrong

  • What Went Well

    • PRIME results demonstrated clinically meaningful reductions in neonatal complications and utilization, with 25% lower NMI and 18% shorter neonatal LOS (modified ITT), and 22% reduction in NICU admissions (ITT); management believes this resonates with payers seeking cost savings .
    • Strengthened balance sheet and runway: raised $57.5M in Feb 2025; management reiterated cash runway into 2028, supporting measured commercial expansion .
    • 2024 gross cash expense contained at ~$28.6M vs prior expectation of “< $30M,” demonstrating cost discipline ahead of a 2025 commercial ramp .

  • What Went Wrong

    • Revenue remains minimal and declined year over year: Q4 2024 revenue $0.024M vs $0.041M in Q4 2023; continued low volumes ahead of coverage/guideline inflection .
    • Operating expense mix shifted toward commercialization, lifting SG&A and widening net loss: Q4 SG&A $6.3M (vs $5.0M prior year); net loss $8.6M vs $7.9M a year ago .
    • Slight EPS miss vs consensus ($(0.25) vs $(0.24)*) amid thin analyst coverage, underscoring that estimate visibility remains limited near-term .

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.041 $0.024 $0.029 $0.024
Net Loss ($USD Millions)$(7.925) $(8.303) $(7.919) $(8.579)
Diluted EPS ($)$(0.25) $(0.25) $(0.24) $(0.25)

  • Operating expenses components (select): | Metric | Q2 2024 | Q3 2024 | Q4 2024 | |---|---|---|---| | R&D Expense ($USD Millions) | $4.41 | $3.50 | $3.14 | | SG&A Expense ($USD Millions) | $4.9 | $5.4 | $6.3 |

  • Liquidity/KPIs: | KPI | Period | Value | |---|---|---| | Cash, cash equivalents and available‑for‑sale securities ($USD Millions) | 12/31/2024 | $68.2 | | 2024 Gross Cash Expense ($USD Millions) | FY 2024 | ~$28.6 |

Vs. Estimates (S&P Global)

MetricPeriodConsensus*ActualBeat/Miss
Revenue ($USD)Q4 2024$0*$24,000 Beat
EPS ($)Q4 2024$(0.24)*$(0.25) Miss

Values retrieved from S&P Global.

Note: Margins are not decision-useful at current scale given de minimis revenue; focus remains on OpEx trajectory and evidence/commercial milestones .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Operating Expenses (gross cash expense)FY 2025—$30–$35M New
Cash RunwayMulti‑year—Into/through 2028 Extended (post raise)

Management did not provide explicit revenue/margin guidance; focus is on evidence publication, commercialization build‑out, reimbursement progress, and geographic expansion .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Evidence/publication (PRIME/AVERT)AVERT published; PRIME analysis underway; targeting spring conference timelines PRIME presented; planning peer‑reviewed publication; multiple PI‑led analyses expected Accelerating
Commercialization rampBuilding cost‑effective awareness, selective hires; consumer‑initiated testing, ambient whole blood rollout 2025 OpEx ramp to $30–$35M for targeted geo rollout, awareness, field teams, rev cycle optimization Accelerating
Payer/Medicaid strategyLaying groundwork; awareness to support coverage Targeting states with high preterm rates; partnering to demonstrate cost savings; Medicaid ~43% of births New emphasis
EU/assay strategy—Agreement to develop immunoassay for EU to enable decentralized model New
Pipeline (Time‑to‑Birth, Predictive Analytics)Predictive analytics in beta (Q3) Time‑to‑Birth targeted 2H 2025; predictive analytics production‑scale 2H; Time‑to‑Birth priced ~$150 Advancing
Operational efficiency/cash2024 OpEx reductions; narrowed net loss (Q2) 2024 gross cash expense ~$28.6M; runway guided into 2028 after $57.5M raise Stable/Improving

Management Commentary

  • “We are pleased with our progress during the year and, more recently, with the results of our full PRIME study… which we believe will promote our mission to mitigate the societal and healthcare costs of spontaneous premature birth…” — Zhenya (Evguenia) Lindgardt, CEO .
  • PRIME outcomes: “both primary outcomes met success criteria, showing a 25% reduction in [NMI] and an 18% reduction in neonatal length of hospital stay… a 20% reduction in NMI and 22% reduction in NICU admissions [in ITT].” .
  • Commercial ramp and OpEx: “For 2025… targeted range for cash operating expenses is $30 million to $35 million… driven by planned… investments in commercialization.” — CFO Austin Aerts .
  • Medicaid opportunity/timing: “It is unusual for a screening test to generate savings within a year… we think… not a multiyear affair… could make some really nice inroads even this year.” — CEO .

Q&A Highlights

  • Path to guidelines: Three pillars — more publications (incl. multiple PRIME sub‑analyses), real‑world evidence studies, and clinical adoption to spur society action; timing uncertain but plausible within 1–3 years given last ACOG 234 update in Aug 2021 .
  • Medicaid/state focus: Early partnerships to measure cost of care; initial geographies include NV, LA, TX, CA; emphasis on high preterm‑rate states and ROI from reduced NICU admissions/days .
  • 2025 spending and runway: Commercial spend to drive adoption; cash runway into 2028 under current plans; revenue assumptions in runway model modest (not disclosed) .
  • Commercial buildout: Regional account managers, medical liaisons, revenue cycle and payer team expansion in targeted waves; coordinated with payer/employer engagement .
  • Pipeline: Time‑to‑Birth (consumer‑directed) and predictive analytics targeted for 2H 2025; Time‑to‑Birth price point around $150 .

Estimates Context

  • Q4 2024 vs consensus: EPS $(0.25) vs $(0.24)* (miss by $0.01); revenue $24k vs $0* (trivial beat). Coverage remains thin (2 EPS and 2 revenue estimates for Q4 2024*), limiting signal quality .
    Values retrieved from S&P Global.
  • Forward implications: With 2025 OpEx stepping up to fund commercialization, estimate models may need higher SG&A while revenue ramps remain contingent on PRIME publication, early Medicaid partnerships, and EU assay progress .

Key Takeaways for Investors

  • PRIME outcomes materially strengthen the clinical and economic case, key to payer conversations and guideline consideration; peer‑reviewed publication is a major near‑term catalyst .
  • Liquidity runway into 2028 post $57.5M raise provides time to execute measured commercialization and evidence programs without near‑term financing overhang .
  • 2025 is an investment year: cash OpEx $30–$35M targeted toward targeted geo rollouts, field buildout, payer engagement, and awareness; monitor spend discipline vs adoption KPIs .
  • Medicaid/state pilots could unlock early coverage pathways given immediate NICU‑related savings potential; watch NV/LA/TX/CA for first proof points .
  • EU optionality via immunoassay development broadens addressable market with a decentralized model aligned to European systems .
  • Revenue near-term remains minimal; valuation sensitive to evidence/publication timing, early payer wins, and initial volume indicators as commercialization scales .
  • Pipeline milestones (Time‑to‑Birth ~2H 2025 at ~$150; predictive analytics scale‑up) offer incremental engagement and potential revenue layers beyond PreTRM .

Supporting detail and sources:

  • Q4 2024 press release (financials, PRIME highlights, cash runway and raise)
  • 8‑K (Item 2.02, financial tables, press release exhibit)
  • Q4 2024 earnings call transcript (prepared remarks, guidance, strategy, Q&A)
  • Prior quarters’ press releases (trend context)