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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)

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Thousands)$123 $0 $24
Total Operating Expenses ($USD Thousands)$11,583 $9,097 $9,277
Loss from Operations ($USD Thousands)$(11,460) $(9,097) $(9,253)
Net Loss ($USD Thousands)$(10,542) $(8,097) $(8,303)
EPS, Basic & Diluted ($)$(0.34) $(0.25) $(0.25)

Operating Expense Mix

MetricQ2 2023Q1 2024Q2 2024
Research & Development ($USD Thousands)$3,688 $3,683 $4,406
Selling & Marketing ($USD Thousands)$2,872 $1,227 $1,099
General & Administrative ($USD Thousands)$4,943 $4,170 $3,752

Balance Sheet and Liquidity

MetricDec 31, 2023Mar 31, 2024Jun 30, 2024
Cash & Cash Equivalents ($USD Thousands)$3,880 $4,239 $4,664
Marketable Securities – Current ($USD Thousands)$45,199 $48,734 $46,276
Marketable Securities – Long‑Term ($USD Thousands)$30,841 $32,386 $30,006
Deferred Revenue ($USD Thousands)$20,235 $20,231 $20,228
Total Assets ($USD Thousands)$95,441 $89,886 $84,861
Cash, Cash Equivalents & AFS Securities (Mgmt Quote)≈$80.9M (as of 6/30/24)

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

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Operating ExpensesFY 2024N/AAround $26M New disclosure
Cash RunwayMulti‑yearN/A“Well into 2027” New disclosure
Revenue/EPSFY/QtrNone providedNone providedMaintained
Capital MarketsN/AN/AFiled S‑3; entered ATM with TD Cowen New facility (flexibility)

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

TopicPrevious Mentions (Q‑2)Previous Mentions (Q‑1 2024)Current Period (Q2 2024)Trend
Evidence (AVERT/PRIME)Not available in archiveSubmitted PRIME interim for publication; PRIME deliveries complete; AVERT/PRIME central to adoption AVERT published (front cover); PRIME database lock targeted mid‑Sep; aim to publish around spring conferences; engaging guideline bodies Execution progressed
Sample Collection & COGSN/AValidated ambient whole‑blood kits; new lab workflow; up to ~60% COGS reduction; higher capacity/throughput Receiving commercial samples; NY conditional approval; expecting 35–50%+ COGS reduction vs old process Operationalization and validation
Commercial AwarenessN/ATV programs planned; state targeting; international exploration Launched campaign with leading medical network; ~22,000 HCPs targeted, 23.4% “deep engagement”; TV programs to air before year‑end Scaling outreach and channels
Payer/GuildelinesN/AActive engagement; to reconvene near publication Positive payer feedback on economic value (NICU day savings: screening 3–4 mothers per NICU day); more payer meetings this fall Building momentum
Capital & RunwayN/ACash $85.4M (3/31/24); disciplined opex; optional $5M investments as warranted Cash ≈$80.9M (6/30/24); FY24 cash opex ~ $26M; runway into 2027; S‑3/ATM established Runway reiterated; added flexibility

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.