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BIOCRYST PHARMACEUTICALS INC (BCRX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 total revenue rose 40.8% year over year to $131.5M, driven by ORLADEYO net revenue of $124.2M (+36.6% y/y); FY 2024 ORLADEYO revenue reached $437.7M (+34.3% y/y) .
  • Management raised FY 2025 guidance: ORLADEYO net revenue to $535–$550M (from $515–$535M) and total revenue to $560–$575M (from $540–$560M), citing stronger Medicare paid therapy under the Inflation Reduction Act and robust demand; non-GAAP OpEx reiterated at $425–$435M .
  • Q4 GAAP operating loss narrowed to $4.5M vs. $42.7M last year; non-GAAP operating profit was $16.8M; net loss improved to $26.8M (−$0.13 EPS) vs. $61.7M (−$0.31 EPS) in Q4 2023 .
  • Key 2025 catalysts: pediatric NDA filing to expand ORLADEYO to ages 2–11 (granules), initial clinical data for BCX17725 (Netherton syndrome) and avoralstat (DME) by year-end; management targets approaching positive quarterly EPS and cash flow in 2H 2025 .
  • Note: Wall Street consensus estimates from S&P Global were unavailable due to request limit; estimate comparison not provided [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • Strong topline: Q4 total revenue +40.8% y/y to $131.5M; ORLADEYO net revenue +36.6% y/y to $124.2M; ex-U.S. ORLADEYO mix increased to 13.9% in Q4 (11.8% for FY) .
  • Profitability trajectory: FY 2024 non-GAAP operating profit of $62.9M; Q4 non-GAAP operating profit of $16.8M; management expects approaching positive EPS and cash flow in 2H 2025 .
  • Commercial momentum and payer tailwinds: “We are seeing favorable early signs that many more Medicare patients taking ORLADEYO are able to afford therapy because their copayments are lower under the Inflation Reduction Act,” raising 2025 ORLADEYO guidance to $535–$550M .

What Went Wrong

  • Q4 GAAP operating loss persisted (−$4.5M) and net loss remained (−$26.8M; −$0.13 EPS), reflecting ongoing SG&A investments and interest expense ($24.4M) despite improved revenue .
  • Reauthorization dynamics likely flatten Q1 revenue vs. Q4 due to temporary free product and gross-to-net impacts; FX headwind ~$5M expected in EU .
  • IP headwind: paragraph IV ANDA challenge against certain ORLADEYO patents (exp. 2039); company intends to vigorously defend .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($USD Millions)$109.3 $117.1 $131.5
ORLADEYO Net Revenue ($USD Millions)$108.3 $116.3 $124.2
Other/RAPIVAB-related Revenue ($USD Millions)$1.0 $0.8 $7.3
Cost of Product Sales ($USD Millions)$1.7 $3.2 $6.1
R&D Expense ($USD Millions)$37.6 $41.1 $49.4
SG&A Expense ($USD Millions)$61.2 $65.1 $80.5
GAAP Operating Income (Loss) ($USD Millions)$8.8 $7.7 $(4.5)
Non-GAAP Operating Profit ($USD Millions)$21.9 $24.9 $16.8
Interest Expense ($USD Millions)$24.7 $24.8 $24.4
Net Loss ($USD Millions)$(12.7) $(14.0) $(26.8)
Diluted EPS ($)$(0.06) $(0.07) $(0.13)
Operating Cash Use ($USD Millions)$0.2 (use) $13.1 (increase) $8.4 (use)
Segment/GeographyQ2 2024Q3 2024Q4 2024
ORLADEYO Net Revenue ($USD Millions)$108.3 $116.3 $124.2
ORLADEYO ex-U.S. Mix (%)11% 11.4% 13.9%
RAPIVAB-related Revenue ($USD Millions)$1.0 $0.8 $7.3
Margin MetricQ2 2024Q3 2024Q4 2024
GAAP Operating Margin (%)8.0% 6.6% −3.4%
Net Income Margin (%)−11.6% −12.0% −20.4%
KPIsQ2 2024Q3 2024Q4 2024
Paid Product Rate (U.S., %)74.4% 74.8% 73.5%
ORLADEYO ex-U.S. Mix (%)11% 11.4% 13.9%
New U.S. Prescribers Added—67 —
Patient Retention on Paid Therapy (≥1 year)~60% (company observation) ~60% ~60%
Cash, Cash Equivalents & Investments (Period-End, $USD Millions)$336.3 $349.4 $341.2

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ORLADEYO Net Revenue ($USD Millions)FY 2025$515–$535 $535–$550 Raised
Total Revenue ($USD Millions)FY 2025$540–$560 $560–$575 Raised
Non-GAAP Operating Expenses ($USD Millions)FY 2025$425–$435 $425–$435 (reiterated) Maintained
GAAP Operating Expenses ($USD Millions)FY 2025$485–$495 Not updated in Q4 release —
Profitability Outlook2H 2025Approach positive EPS & cash flow Approach positive EPS & cash flow Maintained

Drivers of changes: Medicare copay affordability under IRA increasing paid therapy in Medicare, strong new prescription demand, with modest FX headwind (~$5M in EU) embedded in guidance .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
Medicare/IRA impact on paid ratesPaid rate improved to 74.4% in Q2; 74.8% in Q3; demand strong Faster-than-expected Medicare paid therapy; raising 2025 guidance Improving tailwind
Pediatric ORLADEYO (APeX-P) & NDAPeds label expansion planned for 2025 Interim analysis shows safety, sustained attack reduction; NDA this year De-risking; regulatory catalyst
Netherton (BCX17725)Advanced to clinic; initial data expected 2025 Phase 1 progressing; aim for “functional cure”; early patient dosing mid–3Q; biomarker KLK5 suppression targeted Advancing; potential high-impact
DME (avoralstat)Plan to enter clinic in 2025 Phase 1 directly in patients; suprachoroidal injection; durability signals from preclinical imaging Moving into clinic
Ex-U.S. growth and FXEx-U.S. mix ~11–11.4% in Q2/Q3 Ex-U.S. mix 13.9% in Q4; FX headwind ~$5M in EU in guidance Mixed: growth vs FX headwind
IP/Generic risk—ANDA paragraph IV challenge to patents expiring 2039; company to defend Elevated regulatory risk

Management Commentary

  • CEO: “We ended 2024 with the strongest execution and performance in the company's history…we not only generated a non-GAAP operating profit…over $60 million…The magnitude of the free cash flow we now expect over the next 3 years will likely further transform our company.”
  • CCO: “A much higher percentage of Medicare patients on ORLADEYO can afford their copayments…As a result, we are raising our ORLADEYO revenue guidance…to $535–$550M.”
  • CFO: “Total revenue for the quarter came in at $131.5M…non-GAAP operating profit of $62.9M for the year…we expect to have more than $600M of cash on hand [by 2027]…reinforcing our position that we are capital markets independent.”
  • Chief R&D Officer: “APeX-P…oral granule formulation…safe and well tolerated…median monthly attack rate remained at 0 through month 12…on track to file our NDA this year.”

Q&A Highlights

  • Medicare paid mix and guidance: Paid rate across the book was 73.5% at year-end; Medicare paid rate ~55–56% with expectation of improvement in 2025; Q1 revenue likely flat to slightly down vs Q4 due to reauth/free product and gross-to-net; FX headwind ~$5M in EU included in guidance .
  • Netherton development: Expect initial patient dosing around mid-year to 3Q; looking for robust KLK5 suppression and skin healing; small patient numbers may suffice for efficacy signal; potential single pivotal trial depending on effect size .
  • Ex-U.S. cadence: Q4 ex-U.S. ORLADEYO % higher due to distributor shipments and improved Japan economics; 2025 mix may be slightly deflated by stronger U.S. growth despite continued ex-U.S. momentum .
  • Pediatric retention/tolerability: 25 of 29 children remained on study; tolerability and PK aligned with adult/adolescent experience; U.S., EU, JP regulatory paths discussed .
  • Avoralstat TPP & design: Aim for infrequent injections (q3–6 months) to reduce burden; Phase 1 directly in patients with suprachoroidal injection and edema/visual acuity assessments over 4–16 weeks .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS, revenue, and EBITDA was unavailable due to request limit. As a result, we cannot quantify beats/misses versus Street for this quarter. We attempted to retrieve “Primary EPS Consensus Mean,” “Revenue Consensus Mean,” and “EBITDA Consensus Mean,” but encountered a daily request cap [GetEstimates error].
MetricQ4 2024 ActualQ4 2024 ConsensusVariance
Revenue ($USD Millions)$131.5 Unavailable—
EPS (GAAP, $)$(0.13) Unavailable—
Non-GAAP Operating Profit ($USD Millions)$16.8 Unavailable—

Implication: Given raised FY 2025 guidance and qualitative demand tailwinds, Street models may need upward revisions on ORLADEYO and total revenue; FX and Q1 reauthorization dynamics should be reflected in near-term quarterly phasing .

Key Takeaways for Investors

  • Revenue momentum is intact: Q4 ORLADEYO net revenue +36.6% y/y; ex-U.S. mix rising to 13.9%; FY non-GAAP operating profit of $62.9M signals operating leverage .
  • 2025 guidance raised early: ORLADEYO $535–$550M, total revenue $560–$575M; driver is improved Medicare affordability under IRA and robust demand; watch FX headwind (~$5M) .
  • Near-term phasing: Expect Q1 revenue flat to slightly down vs Q4 due to reauthorization/free product and gross-to-net; strength should resume after reauth season .
  • Clinical catalysts: Pediatric ORLADEYO NDA in 2025; interim APeX-P shows sustained attack rate reduction; initial data readouts for BCX17725 and avoralstat by year-end offer optionality beyond HAE .
  • Risk monitor: Paragraph IV ANDA challenge to ORLADEYO patents (2039 expirations) introduces IP overhang; management intends to defend aggressively .
  • Balance sheet and capital allocation: ~$341M cash at year-end; management targets capital markets independence with >$600M cash by 2027; debt reduction and cost of capital focus .
  • Trading lens: Near-term catalyst stack (raised guidance, pediatric NDA path, upcoming clinical data) and improving payer dynamics create upside narrative; monitor Q1 print for reauth impacts and FX, and any developments on the ORLADEYO IP front .