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PI

PRECIGEN, INC. (PGEN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $2.92M, a significant beat vs Wall Street consensus ($0.50M), driven by collaboration/licensing recognition and early launch activities for PAPZIMEOS . Consensus revenue was $0.50M* while actual revenue was $2.92M .
  • GAAP diluted EPS was $(1.06), missing consensus of $(0.095)*, largely due to non‑cash items: $111.5M warrant liability increase and a $179.0M deemed dividend tied to preferred conversion, together impacting EPS by ~$0.95 per share .
  • PAPZIMEOS launch momentum: drug shipping; >90% target institutions engaged; >100 patients registered in the Patient Hub; payer coverage progressing rapidly (press release “>100M lives” vs call “>80M lives”; Medicare/Medicaid in place) .
  • Balance sheet strengthened: cash, cash equivalents, and investments $123.6M; $100M first tranche from a $125M non‑dilutive credit facility; CFO expects cash plus PAPZIMEOS revenues to fund operations to cash flow break‑even by end of 2026 .
  • Regulatory catalysts: EMA MAA submitted in November for adult RRP; pediatric RRP trial preparation and potential redosing opportunities discussed, supporting medium‑term adoption and durability narrative .

What Went Well and What Went Wrong

What Went Well

  • PAPZIMEOS approval and commercial readiness: full FDA approval with broad adult RRP label; drug shipping; rapid engagement across institutions; strong early patient identification .
  • Payer coverage and access: more than 100M covered lives in release, Medicare/Medicaid coverage, and robust formulary progress; management cites “pent‑up demand” and >100 patients registered .
  • Durability data supports standard‑of‑care positioning: 83% (15/18) complete responders still surgery‑free at median 36 months; surgery reduction in 86%/91%/95% of patients in Years 1/2/3; no new safety signals; EMA filing broadens runway .

Management quotes:

  • “PAPZIMEOS…represents the best data…ever generated in adults with RRP…51% complete response…durability…three years” — CEO Helen Sabzevari .
  • “Our field team has now engaged with 90% of our target institutions…over 100 patients registered…payer coverage coming through” — CCO Phil Tennant .
  • “We expect…gross‑to‑net…in the high teens to low 20%” — CFO Harry Thomasian .

What Went Wrong

  • Large non‑cash charges and GAAP optics: warrant liability (+$111.5M) and deemed dividend ($179.0M) drove net loss to $(325.3)M and EPS $(1.06), obscuring operating progress .
  • SG&A surged +$14.2M (+144% y/y) to support commercial launch, reflecting higher sales/marketing and professional fees; Q4 will carry ongoing launch costs .
  • Near‑term visibility limited: no revenue guidance; management will not disclose dosing specifics until Q4, adding uncertainty on early uptake trajectory .

Financial Results

P&L and Balance Sheet (quarterly trend and vs estimates)

MetricQ1 2025Q2 2025Q3 2025Consensus Q3 2025
Revenue ($USD)$1.34M $0.82M*$2.92M $0.50M*
Net Income ($USD)$(54.15)M $(26.64)M*$(146.34)M —
Diluted EPS ($USD)$(0.18)* $(0.09)*$(1.06) $(0.095)*
Operating Loss / EBIT ($USD)$(22.60)M $(27.86)M*$(34.48)M —
Total Operating Expenses ($USD)$23.94M $28.71M*$37.40M —
Cash & Equivalents ($USD)$6.06M $13.76M*$14.32M —
Total Debt ($USD)$5.42M*$5.15M*$92.89M —

Values with an asterisk (*) retrieved from S&P Global.

Estimate comparison (Q3 2025):

  • Revenue: $2.92M vs $0.50M consensus — bold beat .
  • EPS: $(1.06) vs $(0.095) consensus — bold miss, driven by non‑cash items .

Revenue Composition (Q3 2025)

Revenue ComponentQ3 2025 ($USD)
Collaboration & Licensing$1.818M
Product Revenues$0.162M
Service Revenues$0.942M
Other Revenues$0.000M
Total$2.922M

KPIs (Launch/Commercial)

  • Patients registered in PAPZIMEOS Patient Hub: >100 .
  • Institutions engaged: >90% of target .
  • Covered lives: >100M (press release) vs >80M (call timing reference); Medicare/Medicaid coverage confirmed .
  • Inventory: ~$3.06M at quarter‑end .
  • Revenue recognition: upon receipt by specialty pharmacy/IDN; not at injection .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue guidanceFY/Q4 2025NoneNone; no revenue guidance provided Maintained (no guide)
Gross‑to‑Net Adjustment (%)Ongoingn/aHigh teens to low 20% New detail
Cash Flow BreakevenBy end 2026n/aTarget cash flow breakeven by end of 2026 New target
Revenue Recognition PolicyOngoingn/aRecognize upon receipt by specialty pharmacy/IDN Clarified
EMA Filing2025n/aMAA submitted Nov 2025 for adult RRP New milestone
Pediatric RRP Trial2026+n/aWorking toward initiation; redosing data generation planned New development focus

Earnings Call Themes & Trends

TopicPrevious Mentions (Q‑2 and Q‑1)Current Period (Q3 2025)Trend
Regulatory/ApprovalQ1: BLA accepted; PDUFA Aug 27, 2025 Full FDA approval with broad adult RRP label; EMA MAA submitted Positive progression
Commercial LaunchQ1: Readiness activities; EVERSANA selected Drug shipping; >90% institutions engaged; >100 patients registered; strong HCP enthusiasm Accelerating
Payer CoverageQ1: Planning; market sizing (27k adult RRP) >100M covered lives in release; Medicare/Medicaid; call noted >80M as of prior week Rapidly improving
Manufacturing/SupplyQ1: Manufacturing readiness In‑house cGMP drug substance manufacturing; validated cold chain; no adoption impact Robust infrastructure
Durability/Clinical ValueQ1: 51% CR; durable beyond 12 months 83% CR sustained at median 36 months; 86–95% surgery reduction over 3 years; no new safety events Strengthening evidence
Redosing OpportunityQ1: n/aFDA encouraged redosing; physician discretion; payer support via durability data Emerging lever
Geography ExpansionQ1: EU interest implied (ODD) EMA MAA filed November Advancing
Financial StrategyQ1: Cash runway into 2026 $100M tranche drawn; $123.6M cash/investments; breakeven targeted end 2026 Strengthened

Management Commentary

  • “PAPZIMEOS…addresses the underlying root cause…51% complete response…15 of 18 complete responders remaining surgery‑free at a median duration of three years…broad label for all adult RRP patients” — CEO Helen Sabzevari .
  • “Drug is available and has started shipping…field team engaged with 90% of target institutions…over 100 patients registered…payer coverage advancing rapidly” — CCO Phil Tennant .
  • “We operate a dedicated in‑house cGMP facility…validated logistics…no impact from cold chain on adoption” — COO Rutul Shah .
  • “Gross‑to‑net…in the high teens to low 20%…we expect our cash and investment balance plus PAPZIMEOS revenues to fund operations to cash breakeven” — CFO Harry Thomasian .

Q&A Highlights

  • Reimbursement/dosing cadence: Shipping begun; reimbursement policies progressing; specifics on dosed patients to be shared with Q4 results .
  • Hub conversion: Expect majority of hub‑registered patients to pull through to treatment; institutions also using their own hubs; strong funnel momentum .
  • Cash breakeven: Company not guiding revenue; targets cash flow breakeven by end of 2026 .
  • Bolus duration: Pent‑up demand expected to last “quite a while” given 27k adult RRP pool plus incident cases; broad label supports early intervention .
  • Redosing: FDA encouraged; physician discretion; payer acceptance supported by durability data (1–3 years) .
  • Revenue recognition: Revenue recognized upon receipt by specialty pharmacy/IDN, not at injection .

Estimates Context

  • Revenue: Actual $2.92M vs consensus $0.50M* — bold beat .
  • EPS: Actual $(1.06) vs consensus $(0.095)* — bold miss due to non‑cash warrant liability and deemed dividend impacts totaling ~$0.95/share .
  • Coverage: Consensus based on limited analyst participation (# of estimates: 2 for both revenue and EPS)*, suggesting higher volatility in near‑term modeling.

Values with an asterisk (*) retrieved from S&P Global.

MetricQ3 2025 ConsensusQ3 2025 Actual
Revenue ($USD)$0.50M*$2.92M
Primary EPS ($USD)$(0.095)*$(1.06)
Primary EPS – # of Estimates2*—
Revenue – # of Estimates2*—

Key Takeaways for Investors

  • Launch momentum and access are tracking ahead of early expectations (institutions engaged, hub registrations, payer coverage), positioning PAPZIMEOS to become standard of care in adult RRP .
  • Near‑term financial optics are noisy due to non‑cash items; focus on operating loss trajectory and revenue recognition mechanics (upon receipt), which should show clearer progress starting in Q4 .
  • Durability and redosing create compelling economic value for payers and patients, supporting longer‑term adoption and potential retreatment revenue streams .
  • Global expansion and pediatric development provide incremental TAM expansion; EMA MAA filing adds 2026+ optionality .
  • Gross‑to‑net in the high‑teens/low‑20% range should be factored into top‑line modeling; SG&A will remain elevated near term to support launch .
  • Liquidity is solid with $123.6M cash/investments plus $100M facility draw; management targets cash flow breakeven by end 2026, contingent on launch execution .
  • Watch Q4 disclosures for initial dosing/revenue details, payer traction updates, and formulary approvals — likely stock catalysts tied to tangible launch KPIs .