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BIOCRYST PHARMACEUTICALS INC (BCRX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was BioCryst’s strongest quarter to date, with total revenue of $163.4M (+50% y/y) and ORLADEYO net revenue of $156.8M (+45% y/y), driving GAAP operating profit of $29.8M and non-GAAP operating profit of $57.0M .
  • Results exceeded Wall Street: revenue beat consensus by ~$13.5M and S&P “Primary EPS” came in above the estimate; GAAP EPS was $0.02 and non-GAAP EPS $0.15, with ORLADEYO demand, paid shipments efficiency, fewer discontinuations, and gross-to-net improvements supporting the beat .
  • Guidance maintained: FY25 global net ORLADEYO revenue $580–$600M; non-GAAP OpEx $440–$450M; management expects full-year net income and positive cash flow in 2025 .
  • Strategic catalyst: definitive agreement to sell European ORLADEYO business for up to $264M (closing expected early Oct.), enabling retirement of all remaining term debt and improving margins and cash generation .

What Went Well and What Went Wrong

  • What Went Well

    • Record ORLADEYO quarter: $156.8M (+45% y/y); total revenue $163.4M (+50% y/y); GAAP operating profit $29.8M and non-GAAP operating profit $57.0M .
    • Commercial execution: highest-ever new patient prescriptions; US ORLADEYO revenue ~$140.3M (89.5% of global), 69 new US prescribers vs 59 in Q1; gross-to-net near lower end of 15–20% range .
    • Management confidence: “best in the company’s history” and “path to $1B at peak” with sustained demand and operating profit acceleration; “upper half” of FY25 revenue guidance after removing Q4 Europe .

  • What Went Wrong

    • OpEx mix shift and deal costs: SG&A rose to $87.4M (+43% y/y), including ~$10.7M deal-related costs/stock comp and ~$6.5M ORLADEYO regulatory/safety/quality/manufacturing expenses reclassified from R&D .
    • Interest and extinguishment charges: interest expense $21.6M, plus a $4.2M loss on extinguishment of debt; although down y/y, still a headwind to GAAP EPS .
    • Pending European divestiture uncertainty and MFN policy monitoring: guidance notes updated OpEx post-close; management watching MFN risks; Medicaid exposure ~10–15% of patients .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Total Revenues ($M)$131.5 $145.5 $163.4
ORLADEYO Net Revenue ($M)$124.2 $134.2 $156.8
Other Revenue ($M)$7.3 $11.3 $6.5
Operating Income ($M)$(4.5) $21.2 $29.8
Net Income ($M)$(26.8) $0.03 $5.1
GAAP Diluted EPS$(0.13) $0.00 $0.02
Non-GAAP Operating Income ($M)$16.8 $42.6 $57.0
Non-GAAP Net Income ($M)N/AN/A$32.3

Margins (GAAP, computed)

MetricQ4 2024Q1 2025Q2 2025
Gross Margin %95.4% (=(131.5-6.1)/131.5) 96.9% (=(145.5-4.6)/145.5) 98.3% (=(163.4-2.8)/163.4)
EBIT Margin %(3.4%) (=(−4.5)/131.5) 14.6% (=21.2/145.5) 18.2% (=29.8/163.4)
Net Income Margin %(20.4%) (=(−26.8)/131.5) 0.0% (=0.03/145.5) 3.1% (=5.1/163.4)

Segment/geography breakdown (ORLADEYO)

MetricQ4 2024Q1 2025Q2 2025
ORLADEYO US Revenue ($M)$107.0 (124.2−17.2) $120.2 $140.3
ORLADEYO ex-US Revenue ($M)$17.2 $14.0 (approx. 10.5% of $134.2M) ~$16.5 (10.5% of $156.8M)
US Share of ORLADEYO (%)86.1% 89.5% 89.5%

KPIs

KPIQ4 2024Q1 2025Q2 2025
New US Prescribers (count)N/A59 69
Paid Patients Rate (%)73.5% at Q4-end ~84% at end-April Expected drift modestly down through year
Gross-to-Net (% of net price)~20% in early Q1, improving to ~15% full-year target Lower portion of 15–20% range Near lower end (closer to 15%)
Discontinuation/Persistency~60% reach 1-year persistency; very sticky beyond 12 months Consistent year-over-year Consistent; slightly improving overall discontinuation

Estimate comparison (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Revenue Consensus Mean ($M)127.8*149.8*163.0*
Revenue Actual ($M)145.5 163.4 (beat) 159.4
Primary EPS Consensus Mean(0.052)*0.0258*0.0710*
Primary EPS Actual0.00 0.038 (beat)*0.16*

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

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Global net ORLADEYO revenueFY 2025$580–$600M (raised in Q1) $580–$600M Maintained
Non-GAAP Operating ExpensesFY 2025$440–$450M (ex-stock comp) $440–$450M (ex-stock comp; update planned post EU sale close) Maintained (update pending)
Net Income & Positive Cash FlowFY 2025Expect net income and positive cash flow Expect net income and positive cash flow Maintained
Term Debt2025$75M prepayment in April +$50M paid in July; intend to retire all remaining term debt upon EU sale close Strengthened balance sheet

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
ORLADEYO demand & paid rateRaised FY25 revenue guidance on IRA tailwind; paid rate improving to ~80–84%; strong prescriber intent Highest-ever new Rx; US revenue ~$140.3M; 69 new prescribers; paid shipments efficiency; fewer discontinuations Strengthening demand; sustained execution
Gross-to-net & pricingTarget full-year ~15% gross-to-net; early Q1 closer to 20% Near lower end of 15–20%; closer to 15% Improving mix/execution
Regulatory/pediatricAPeX-P late-breaker data supports pediatric NDA; filings planned US/EU/JP PDUFA date Dec 12, 2025; straightforward pediatric extrapolation Clear near-term catalyst
Macro/MFN & MedicaidMonitoring MFN; FX headwinds; EU variability Monitoring MFN; Medicaid ~10–15% of patients Neutral risk watch
R&D execution (Netherton, DME)Moving BCX17725/DME into clinic; expectation for initial patient data in 2025 On track for initial data by year-end; detailed Phase I objectives (KLK5 suppression; CSFT reduction) Progressing to patient readouts
Capital allocation & EU saleGuidance raised; early debt paydown EU sale up to $264M; retire term debt post-close; margin uplift; cash to ~$700M by 2027 Positive de-leveraging

Management Commentary

  • “The financial performance this quarter is the best in the company’s history resulting from better-than-expected revenue growth and very meaningful operating profit.” — Jon Stonehouse, CEO .
  • “ORLADEYO continued its upward trajectory… Growth was fueled by increasing demand in the U.S. and internationally, improved efficiency in getting paid shipments, fewer discontinuations, gross-to-net improvements, and continued impact of our real-world evidence.” — Charlie Gayer, President & CCO .
  • “Non-GAAP operating profit for the quarter… was $57M… we generated $45M of cash in the second quarter before any debt prepayment.” — Jon Stonehouse, acting CFO .
  • “Our strong cash flow profile combined with an unlevered balance sheet going forward provides us the ability to deploy capital… whether licensing, acquisitions, or even return of capital.” — Babar Ghias, CFO & Head of Corporate Development .

Q&A Highlights

  • Growth drivers mix: Q2 overperformance driven by volume, gross-to-net improvement, and more efficient paid shipments; demand spike seen as most important for long-term growth .
  • Discontinuation/persistency: ~60% reach one-year persistency; overall discontinuation rate trending slightly down as patient base grows .
  • Competition impact: New HAE approvals (e.g., on-demand oral) not dampening ORLADEYO demand; physicians “aren’t waiting” and prophy remains backbone .
  • Pediatric PDUFA delay: Major amendment extended to Dec 12, 2025; still on track for approval this year .
  • MFN/Medicaid: Monitoring MFN; Medicaid ~10–15% of patients; no immediate impact expected .
  • FY trajectory: Expect paid rate to drift modestly down as mix shifts to new patients; Q3/Q4 growth aligned to new patient demand; Q4 to exclude Europe post-close; management aims for upper half of $580–$600M .

Estimates Context

  • Revenue beat: Q2 2025 revenue $163.4M vs consensus $149.8M — a ~$13.5M beat (drivers: demand, paid shipments, gross-to-net, fewer discontinuations) .
  • EPS beat (S&P “Primary EPS”): Actual 0.038 vs 0.0258 estimate; GAAP diluted EPS reported at $0.02 and non-GAAP EPS at $0.15; definitional differences explain discrepancy between “Primary EPS” and GAAP diluted EPS .
  • Forward quarters: Q3 2025 consensus revenue ~$163.0M and consensus EPS ~0.071; company maintained FY revenue guidance and expects upper-half after removing Q4 Europe .

Values with asterisks in tables were retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue quality improving: beat driven by underlying demand and operational levers (paid shipments, gross-to-net), not one-time items; operating leverage expanding (EBIT margin 18.2%) .
  • Deleveraging and margin uplift: EU sale proceeds expected to retire term debt; ~90% cumulative net interest savings cited over life of loan; improved margin structure post-close .
  • Near-term catalysts: Pediatric ORLADEYO PDUFA (Dec 12), initial patient data in Netherton (KLK5 inhibition) and DME (CSFT reduction) by year-end .
  • Guidance stance: FY25 ORLADEYO revenue $580–$600M maintained; management signaled “upper half” despite removing Q4 Europe; full-year net income and positive cash flow reaffirmed .
  • Competitive narrative: Prophy remains backbone; real-world evidence and physician confidence underpin stickiness; new entrants not disrupting trajectory as per Q2 data/feedback .
  • Execution consistency: New prescribers increased to 69; US share steady at 89.5%; gross-to-net tracking toward ~15% .
  • Strategy evolution: Leadership transition (new CEO in 2026, new CFO) positions BioCryst to consolidate rare disease assets leveraging stronger balance sheet and commercial infrastructure .