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BIOCRYST PHARMACEUTICALS INC (BCRX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered strong top-line growth and significant profitability: total revenue $159.4M (+36% y/y), ORLADEYO net revenue $159.1M (+37% y/y), GAAP operating income $29.6M (+285% y/y), GAAP net income $12.9M (vs. loss in Q3’24) .
  • Guidance raised and costs lowered: FY25 ORLADEYO revenue raised to $590–$600M; FY25 non-GAAP operating expenses lowered to $430–$440M; management “on track” for FY25 net income and positive cash flow .
  • Strategic actions enhance financial profile: sale of European ORLADEYO business and full prepayment of Pharmakon term debt in October; pro forma cash $294M at 9/30/25, term debt $0 .
  • Versus estimates: Q3 non-GAAP EPS materially beat; revenue modestly missed; EBITDA below consensus. Expect estimate revisions on EPS upward; revenue/EBITDA near-term adjustments likely given “other revenue” decline and mix shift. Values retrieved from S&P Global*.
  • Near-term catalysts: Dec 12, 2025 PDUFA for pediatric ORLADEYO granules; Astria Therapeutics acquisition (navenibart) expected to close Q1 2026 .

What Went Well and What Went Wrong

What Went Well

  • ORLADEYO momentum held despite new prophylactic competitors: net revenue $159.1M (+37% y/y), US contribution 89% ($141.6M) .
  • Profitability and leverage improved: GAAP operating income $29.6M (vs. $7.7M in Q3’24); non-GAAP operating income $51.7M (+107% y/y), reflecting operating leverage .
  • Management quotes: “ORLADEYO remains the most differentiated option… prescriber confidence driving continued growth” — Charlie Gayer ; “paid off our debt… very strong financial position, generating operating profit and positive cash flow” — Jon Stonehouse .

What Went Wrong

  • “Other” revenue fell materially ($0.3M vs. $18.1M in Q3’24), reducing total revenue and contributing to the small revenue shortfall vs. consensus .
  • Non-GAAP operating expenses rose y/y to ~$108M, driven by R&D investment and SG&A reclassification (though FY25 guidance lowered) .
  • Interest expense remained elevated at $19.7M in Q3 (albeit -21% y/y); debt service pressure only fully relieved post-quarter via October prepayment .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Total Revenues ($USD Millions)$117.085 $145.534 $163.353 $159.395
ORLADEYO Net Revenue ($USD Millions)$116.319 $134.243 $156.837 $159.077
Operating Income ($USD Millions)$7.692 $21.227 $29.786 $29.591
GAAP Net Income ($USD Millions)$(14.033) $0.032 $5.085 $12.899
GAAP Diluted EPS ($USD)$(0.07) $0.00 $0.02 $0.06
Non-GAAP Operating Income ($USD Millions)$24.941 $42.595 $56.978 $51.687
Non-GAAP Diluted EPS ($USD)$0.02 —$0.15 $0.16
Operating Margin % (Calculated)6.6%14.6%18.2%18.5%
Note: Operating margin is calculated from cited revenue and operating income figures.

Segment breakdown (ORLADEYO):

SegmentQ2 2025Q3 2025
US ORLADEYO Revenue ($USD Millions)$140.3M (89.5% of ORLADEYO) $141.6M (89% of ORLADEYO)
Total ORLADEYO Revenue ($USD Millions)$156.8 $159.1

KPIs:

KPIQ1 2025Q2 2025Q3 2025
New Prescribers (US)59 69 64
Paid Patient Rate (%)84% —82%
1-year Retention (%)——60%
Gross-to-Net (%)——~15% (15–20% expected in 2026)
C1 Normal Share of Patients—“bolus” from new data ~1/3 of patients

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ORLADEYO Global Net Revenue ($USD Millions)FY 2025$580–$600 (Q2 update) $590–$600 Raised
Non-GAAP Operating Expenses ($USD Millions)FY 2025$440–$450 (Q2 update) $430–$440 Lowered
Profitability & Cash FlowFY 2025On track for net income and positive cash flow Remains on track Maintained
Pediatric ORLADEYO Granules (PDUFA)Q4 2025Dec 12, 2025 Dec 12, 2025 Maintained
Astria Acquisition CloseQ1 2026Announced Oct; expected close Q1 2026 Expected close Q1 2026 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1, Q2)Current Period (Q3 2025)Trend
Competitive landscape (new injectables)Confidence that ORLADEYO growth persists; high new patient demand Retention unchanged; new Rx “slightly exceeded” Q3’24; ORLADEYO seen as most differentiated oral prophylaxis Stable-positive
Pediatric ORLADEYO granulesNDA submitted; Dec 12 PDUFA targeted ACAAI data show sustained attack reduction; first targeted oral prophylaxis for age 2–<12 if approved Building momentum
Royalty tail and blended rateStep-down expected over time (OMERS)Blended rate in early teens; continues to decline into single digits over time Improving
Paid patient rate / gross-to-netPaid rate accelerated to 84% in Q1; GtN ~15% Paid rate 82% in Q3; GtN ~15% (15–20% in 2026) Seasonal dip; structurally strong
Debt & balance sheet$75M prepayment; plan to retire term debt post EU sale EU sale closed; ~$199M repaid; zero term debt; pro forma cash $294M Stronger
Pipeline: Netherton (BCX-17725)IND open; initial data 2025 Phase 1 HV data show epidermal distribution; NS data expected Q1’26; exploring IV and SC dosing Advancing
DME (avoralstat)Phase 1 enrolling Strategy to partner/spin-out to focus capital on rare diseases Deprioritized

Management Commentary

  • CEO Jon Stonehouse: “Closed the sale of our European business and paid off our Pharmakon debt… put us in a very strong financial position, generating operating profit and positive cash flow” .
  • President & CCO Charlie Gayer: “Even as two new prophylactic products launched… new prescriptions for ORLADEYO continued at the same strong pace… slightly exceeded the new patient prescription total from the third quarter a year ago” .
  • CFO Babar Ghias: “Non-GAAP operating profit… $51.7M… pro forma cash… ~$294M and zero term debt… anticipate reaching $1B in cash during 2029” .
  • CDO Dr. Bill Sheridan: “Drug… distributed throughout the epidermis… important findings… access to the target enzyme KLK5” (BCX-17725 HV data) .

Q&A Highlights

  • Growth drivers: 37% y/y ORLADEYO growth driven by price/mix via improved paid rate (Medicare) and steady volume; gross-to-net ~15%, expected 15–20% next year .
  • Competitive dynamics: Some switching to injectables expected; overall retention and new patient prescribing patterns unchanged; ORLADEYO patients are “sticky” per market simulation .
  • Royalty burden: Blended royalty rate in early teens, declining toward single digits as thresholds are met and liabilities amortize .
  • Q4 seasonality clarification: One-time drop due to removal of European revenue post-sale; not indicative of ongoing seasonality .
  • Pediatric launch: PDUFA Dec 12; payer position strong; potential initial bolus of pediatric patients post-approval; team already calling on treating physicians .

Estimates Context

MetricConsensus (Q3 2025)Reported Actual (Q3 2025)Surprise
Revenue ($USD Millions)$163.0*$159.395 Slight miss
Primary EPS ($USD)$0.071*$0.16 (non-GAAP diluted) Bold beat
EBITDA ($USD Millions)$43.0*$29.926*Miss
EPS Estimates Count5*——
Revenue Estimates Count10*——
Values retrieved from S&P Global*.

Implications: Expect upward EPS estimate revisions given the magnitude of the beat and lowered FY25 opex guidance; modest downward tweaks to revenue/EBITDA near term as analysts reconcile “other revenue” decline and mix.

Key Takeaways for Investors

  • ORLADEYO demand resilience through competitor launches underpins sustained revenue growth and operating leverage; US share remains ~89% .
  • FY25 guidance raised (revenue) and lowered (non-GAAP opex) while profitability and cash generation targets reaffirmed; this supports multiple expansion arguments .
  • Balance sheet de-risked via European sale and debt retirement; pro forma cash $294M, zero term debt, positioning for Astria close and commercialization investments .
  • Near-term catalysts: pediatric granules PDUFA (Dec 12) and ACAAI data bolstering pediatric efficacy/continuation rates—potential for incremental prescribers and patient adds .
  • Pipeline adds optionality: navenibart expected to drive double-digit HAE revenue growth into 2030s; BCX-17725 early signals de-risk epidermal target engagement .
  • Watch Q4 optics: one-time revenue step-down from EU divestiture should not be extrapolated; company guided that normal Q4 trajectory resumes in 2026 .
  • Trading lens: EPS beat and opex guidance cut are positive near-term catalysts; any volatility around PDUFA, Astria-close financing, and royalty rate trajectory could create entry points.

Citations: Press release and 8-K Q3 2025 ; Earnings call transcript Q3 2025 ; Q2 2025 8-K ; Q1 2025 8-K ; ACAAI pediatric data PR .