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AMICUS THERAPEUTICS, INC. (FOLD)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net product revenue was $149.7M (+30% YoY) driven by Galafold $127.5M (+20% YoY) and Pombiliti+Opfolda $22.2M (+162% YoY); non-GAAP net income was $29.2M and GAAP EPS was $0.05 .
  • 2025 guidance: total revenue growth +17% to +24% (CER), Galafold +10% to +15% (CER), Pombiliti+Opfolda +65% to +85% (CER), gross margin mid-80s, non-GAAP OpEx $350M–$370M, GAAP net income positive in H2 2025 .
  • Strategic catalysts: Netherlands reimbursement (high-prevalence Pompe market) with first commercial patients expected H1 2025; approvals anticipated in Canada and Japan; Australia approved; ~220 Pompe patients treated/scheduled by YE 2024 .
  • Management highlighted momentum in rare disease infrastructure and reiterated goal to surpass $1B total revenue in 2028; FX sensitivity remains meaningful (~$4M per ±1% USD move vs YE’24 rates) .

What Went Well and What Went Wrong

What Went Well

  • “We closed 2024 beating expectations with exceptional revenue growth of 33 percent… a clear path to deliver continued revenue growth and accelerating profitability in 2025” — CEO Bradley Campbell .
  • Galafold continued to show robust demand with ~2,730 patients on therapy; 2024 Galafold revenue $458.1M (+19% at CER) and strong compliance/adherence (>90%) .
  • Pombiliti+Opfolda delivered its first full commercial year: $70.2M in FY2024; ~220 patients treated or scheduled; breadth of prescribers expanding; first-line positioning in Sweden; new reimbursement agreements (Italy, Sweden, Switzerland, Czech Republic, Netherlands) .

What Went Wrong

  • Gross margin expected to step down to mid-80s in 2025 as previously expensed inventory runs off (“hybrid year”); COGS recognition for Pombiliti+Opfolda begins to flow through P&L, lowering margin vs ~90% in 2024 .
  • FX remains a tail risk with no hedging program; ±1% USD change vs YE’24 rates could move 2025 revenues by ~$4M given ~60% ex-US mix .
  • Continued litigation risk remains on Galafold IP with Aurobindo (Lupin stay in place); though Teva settlement sets U.S. generic entry no earlier than Jan 2037, residual legal uncertainty persists .

Financial Results

Quarterly Financials vs Prior Year and Prior Quarter

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Net Product Revenues ($USD Millions)$115.1 $126.7 $141.5 $149.7
GAAP Net Income (Loss) ($USD Millions)$(33.8) $(15.7) $(6.7) $14.7
GAAP EPS ($USD)$(0.11) $(0.05) $(0.02) $0.05
Non-GAAP Net Income ($USD Millions)$2.6 $18.5 $30.8 $29.2
Non-GAAP EPS – Basic ($USD)$0.01 $0.06 $0.10 $0.10
Non-GAAP EPS – Diluted ($USD)$0.01 $0.06 $0.10 $0.09
Cost of Goods Sold ($USD Millions)$11.3 $11.3 $13.3 $14.8
GAAP Operating Expenses ($USD Millions)$107.5 $100.4 $106.6 $118.9
Non-GAAP Operating Expenses ($USD Millions)$87.2 $82.1 $82.6 $97.6

Notes: Q3 metrics per 8-K tables; Q4 metrics per FY24 results slide/table. All figures are reported, not estimates .

Segment Revenue Breakdown

SegmentQ4 2023Q2 2024Q3 2024Q4 2024
Galafold ($USD Thousands)$106,601 $110,817 $120,381 $127,497
Pombiliti + Opfolda ($USD Thousands)$8,481 $15,852 $21,136 $22,209
Net Product Revenues ($USD Thousands)$115,082 $126,669 $141,517 $149,706

KPIs

KPIQ2 2024Q3 2024Q4 2024
Pombiliti+Opfolda patients treated/scheduled186 (5 markets) 203 (end of Oct) ~220 (YE 2024)
Galafold patients on therapy——~2,730 (YE 2024)
Compliance/adherence (Galafold; P+O)>90%>90%>90%
Ex-US revenue mix—60% (Q3) 61% (FY 2024)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue Growth (CER)FY 202426%–31% 30%–32% Raised
Galafold Revenue Growth (CER)FY 202414%–18% 16%–18% Raised
Pombiliti+Opfolda Revenue (CER)FY 2024$62M–$67M $69M–$71M Raised
Non-GAAP Operating ExpenseFY 2024$345M–$360M $340M–$350M Lowered
Total Revenue Growth (CER)FY 2025—17%–24% New
Galafold Revenue Growth (CER)FY 2025—10%–15% New
Pombiliti+Opfolda Revenue Growth (CER)FY 2025—65%–85% New
Gross MarginFY 2025—Mid-80% New
Non-GAAP Operating ExpenseFY 2025—$350M–$370M New
GAAP Net IncomeFY 2025—Positive in H2 2025 New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 & Q-1)Current Period (Q4 2024)Trend
AI/technology initiatives (diagnosis)Not highlighted in Q2 PR; focus on guidance and Swissmedic approval . Q3 call emphasized market execution, Teva settlement .OM1 AI screening with Penn: 580K+ records screened; top-100 high-risk identified; outreach for genetic testing; plan to publish outcomes H2’25 .Increasing emphasis on AI-enabled patient identification.
Supply chain/second source manufacturingNo second-site detail in Q2/Q3 PRs.Second manufacturing site (Dundalk, Ireland with WuXi): successful PPQ, EU inspection; Europe commercial supply in H2’25, U.S. to follow .Risk mitigation via dual-site manufacturing progressing.
Tariffs/macroFX sensitivity disclosed (±$15M for ±5% in 2024) .Minimal tariff exposure in 2025–2026; guidance assumes tariffs remain; FX sensitivity ~$4M per ±1% USD move .Persistent FX exposure; tariff impact limited near term.
Product performanceQ2: Galafold $110.8M (+17% YoY); P+O $15.9M; guidance raised . Q3: Galafold $120.4M; P+O $21.1M; 203 patients treated/scheduled .Q4: Galafold $127.5M; P+O $22.2M; ~220 patients treated/scheduled; >90% adherence .Sustained QoQ growth across both products.
Regional trendsQ2: building reimbursement dossiers; Swissmedic approval . Q3: expanding payor interactions; Czech Republic pricing .Netherlands reimbursement (high-prevalence Pompe market); first commercial patients expected Q1/Q2’25; Italy regional green lights; Sweden first-line positioning .Accelerating EU access; cadence of country launches in H1/H2’25.
Regulatory/legalQ2: Swissmedic approval; JNDA filed later . Q3: Teva settlement (generic entry Jan 2037) .Australia approval; anticipate Canada/Japan decisions in 2025; litigation continues vs Aurobindo, Lupin stay remains .Strengthening IP runway and geographic expansion.
R&D executionQ2: pediatric LOPD/IOPD studies ongoing . Q3: JNDA filed; ongoing registry .Adolescent LOPD submission to FDA in 2025; younger LOPD last patient in 2025; IOPD enrollment to finish by end of 2026; emphasis on real-world evidence .Programmatic progress toward label expansions.

Management Commentary

  • “We have firmly established Amicus as a unique biotechnology company: two growing medicines with long runways… and the financial strength to continue to build the business” — Bradley Campbell, CEO .
  • “We anticipate surpassing $1 billion in total sales in 2028” — FY25 conference presentation .
  • “In terms of FX… a one percentage point move in the dollar up or down is roughly a $4 million revenue impact” — Simon Harford, CFO .
  • “Second manufacturing site… on track for commercial product to come into the supply chain in Europe, probably in the back half of this year and the U.S. the following year” — Bradley Campbell .
  • “OM1 AI diagnostic pilot… identified the top 100 people… with suspicion of undiagnosed Fabry; outreach underway for confirmatory testing” — Jeffrey Castelli, CDO .

Q&A Highlights

  • Switching dynamics: Physicians often wait 12–24 months before switching therapies; growing pool of Nexviazyme patients reaching ~2-year mark supports switch opportunity to P+O in 2025 .
  • Netherlands market: ~125 adult LOPD patients currently treated; first commercial patients expected by late Q1/early Q2’25; five EU markets secured reimbursement with launches ramping through H1’25 .
  • FX/hedging: No hedging program; FX can impact reported revenues; disclosure of ±$4M per ±1% USD move .
  • Tariffs and manufacturing: Minimal tariff exposure expected; dual-site manufacturing progressing (Dundalk) with EU supply H2’25 .
  • Pediatric Pompe timelines: Adolescent LOPD submission in 2025; younger LOPD last patient in 2025; IOPD enrollment by end of 2026; real-world evidence building .
  • Business development: Focus on late-stage, near-commercial assets, regional rights outside U.S.; leverage global rare disease infrastructure .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable at the time of this analysis due to data access limits; therefore, estimate comparison is not included. Values retrieved from S&P Global were not accessible due to request-limit errors.*

Where estimates may need to adjust: Strong Q4 reported growth and 2025 guide (+17–24% CER total revenue; mid-80s GM; GAAP NI positive in H2’25) suggest upward revisions to P+O ramp assumptions and sustained double-digit Galafold growth, while factoring FX headwinds and margin normalization .

Key Takeaways for Investors

  • Q4 delivered broad-based growth with GAAP profitability for the quarter and full-year non-GAAP profitability; 2025 guide implies continued double-digit growth with improving earnings profile in H2’25 .
  • Near-term catalysts: Netherlands launch (Pompe center of excellence), additional EU reimbursement wins, and regulatory decisions in Canada/Japan; expect first patients across new EU markets in H1’25 .
  • Watch margin trajectory: 2024 gross margins ~90% will normalize to mid-80s in 2025 as P+O COGS flow through; monitor pace of second-site supply onboarding .
  • FX is a material variable given ~60% ex-US mix; hedging absent; consider USD sensitivity when modeling reported revenues .
  • Switching cadence in U.S. should accelerate as more Nexviazyme patients hit the 12–24 month window; prescriber breadth/depth expanding across markets .
  • IP runway strengthened via Teva settlement (U.S. generic entry not before Jan 2037), supporting Galafold’s long-term cash generation; residual litigation continues vs Aurobindo .
  • Medium-term thesis: Two commercial assets with expanding access, leverageable infrastructure, and a path to >$1B revenue by 2028; incremental upside from pediatric label expansions and BD-driven portfolio additions .