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AMICUS THERAPEUTICS, INC. (FOLD)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $125.2M, up 13% reported and 15% at constant exchange rates; Galafold grew 5% (6% CER) to $104.2M and Pombiliti + Opfolda grew 90% (92% CER) to $21.0M .
  • Primary EPS (non-GAAP normalized) was $0.03 versus consensus of -$0.052, a clear beat; revenue missed consensus of $136.3M by ~$11.1M as ex-U.S. order timing and a higher UK VPAG rebate weighed on the quarter *.
  • Guidance was adjusted: Total revenue growth to 15–22% (from 17–24%), Pombiliti + Opfolda growth to 50–65% (from 65–85%); Galafold 10–15% maintained; non-GAAP OpEx raised to $380–400M to include $30M DMX-200 upfront. GAAP profitability still expected in H2 2025 .
  • Portfolio catalyst: Exclusive U.S. license for DMX-200 (Phase 3 in FSGS) with modest upfront ($30M) and success-based milestones; FDA alignment on proteinuria as primary endpoint supports de-risked path .

What Went Well and What Went Wrong

What Went Well

  • Strong underlying demand: Galafold patient demand grew 14% YoY and reached ~69% share of treated amenable patients; U.S. Galafold up 18% with record patient counts in Australia .
  • Pombiliti + Opfolda momentum: +92% growth at CER; net new patients and prescriber depth increased; first patients started in newly reimbursed markets (Sweden, Switzerland), with Italy, Czech Republic, Portugal, Netherlands ramping in Q2 .
  • Strategic expansion: In-licensed DMX-200 U.S. rights; FDA aligned on proteinuria primary endpoint; transaction structured with tiered royalties and success-based milestones .

Management quotes:

  • “While some unexpected factors impacted revenue in the quarter, the key performance indicators for both products are very strong and we remain on-track to achieve GAAP profitability during the second half of 2025.” — Bradley Campbell, CEO .

What Went Wrong

  • Revenue miss vs Street: Reported net sales $125.2M vs consensus $136.3M, driven by ex-U.S. order timing and higher-than-anticipated UK VPAG rebate (industry guidance 12–15% vs actual 22%) *.
  • Pombiliti + Opfolda guidance reduced: Patient starts in new launch countries shifted right; VPAG headwind in UK; growth guidance lowered to 50–65% at CER for 2025 .
  • Currency and FX sensitivity: ~60% ex-U.S. revenue; 1% USD move ≈ ~$4M revenue impact, adding volatility to reported results .

Financial Results

Revenue, EPS, Margins (comparisons vs prior quarters and YoY)

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$141.517 $149.706 $125.249
GAAP Diluted EPS ($)$(0.02) $0.05 $(0.07)
Non-GAAP Diluted EPS ($)$0.10 $0.09 $0.03
Gross Profit ($USD Millions)$128.238 N/A$113.551
Gross Margin % (computed)90.6% N/A90.7%

Notes: Gross margin % computed from gross profit/net sales. Q4 2024 gross margin disclosed at ~90% for full-year 2024, and mid-80s expected in 2025 as PomOp COGS phase-in begins .

Segment Revenue Breakdown

Product Revenue ($USD Millions)Q3 2024Q4 2024Q1 2025
Galafold$120.381 $127.497 $104.244
Pombiliti + Opfolda$21.136 $22.209 $21.005
Total Net Product Revenues$141.517 $149.706 $125.249

KPIs

KPIQ1 2025Prior Year / Notes
Galafold patient demand growth+14% YoY Supported by naive population uptake
Share of treated amenable patients (Galafold)~69% Potential to reach 85–90% in mature markets
Ex-U.S. share of total revenue~60% FX sensitivity: ±1% USD ≈ ~$4M
Non-GAAP OpEx ($M)$94.5 +10.4% YoY; GAAP OpEx $121.5M (-2.5% YoY)
Non-GAAP Net Income ($M)$9.0 Versus non-GAAP net loss ($4.6M) in Q1 2024
Cash & Marketable Securities ($M)$250.6 Slightly up vs $249.9 at 12/31/2024

Margins YoY

Margin MetricQ1 2024Q1 2025
Net Sales ($M)$110.403 $125.249
Gross Profit ($M)$96.836 $113.551
Gross Margin % (computed)87.8% 90.7%
COGS % of Sales (Mgmt disclosure)12.3% 9.3%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue Growth (CER)FY 202517%–24% 15%–22% Lowered
Galafold Revenue Growth (CER)FY 202510%–15% 10%–15% Maintained
Pombiliti + Opfolda Growth (CER)FY 202565%–85% 50%–65% Lowered
Gross MarginFY 2025Mid-80% Mid-80% Maintained
Non-GAAP Operating ExpensesFY 2025$350M–$370M $380M–$400M (incl. $30M DMX-200 upfront) Raised
GAAP Net IncomeFY 2025Positive in H2 2025 Positive in H2 2025 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
AI/technology initiatives (diagnosis)Detailed OM1 AI pilot at Penn; UK health inequity diagnostics initiative Reiterated progress and plan to share outcomes; continued collaboration Continuing; building evidence
Supply chain & tariffsSecond-source manufacturing in Ireland; limited tariff impact expected; inventory planning Onshoring drug product with Sharp Sterile; 2025 U.S. inventory in place; no material impact expected Diversification; low near-term tariff risk
Product performanceQ3: Galafold +20% YoY; Pom-Op momentum; non-GAAP profitability Galafold +5% (6% CER); Pom-Op +92% (CER); April showed best month for new commercial starts Strong demand; timing/VPAG headwinds
Regulatory/legalTeva settlement allows U.S. generic entry only from Jan 2037 Netherlands first-position for Pom-Op; approvals in Australia/Canada; Japan decision expected in 2025 Access expanding; EU traction
R&D executionPediatric Pompe studies enrollment; registry evidence Long-term data reinforcing Pom-Op; pediatric LOPD cohort submission planned; IOPD enrollment ongoing Advancing label expansion
Macro/FX60% ex-U.S. revenue; ±1% USD ≈ ~$4M impact Same sensitivity reiterated; CER used for guidance Ongoing exposure managed

Management Commentary

  • “We have delivered yet another quarter of strong double-digit revenue growth… we reiterated that we are on track to achieve GAAP profitability in the second half this year.” — Bradley Campbell, CEO .
  • “Galafold revenue reached $104.2M, up 6% at CER… new patient starts globally up 14% in the quarter.” — Sébastien Martel, Chief Business Officer .
  • “We do not expect a material impact to our business operations this year [from tariffs]… announcing manufacturing with Sharp Sterile in the U.S.” — Sébastien Martel .
  • “DMX-200… FDA alignment on proteinuria as a primary endpoint for approval… Phase III enrollment at 185 of 286 patients.” — Jeffrey Castelli, Chief Development Officer .

Q&A Highlights

  • UK VPAG rebate surprise: Industry guided 12–15% but settled at 22%, creating an in-quarter and full-year headwind; Galafold expected to offset via demand; Pom-Op guidance adjusted accordingly .
  • Netherlands impact: First-position selection for adults with LOPD (~150+ patients), but a single-center bottleneck will push starts into Q2–H2; Sweden also first-position with broad uptake .
  • U.S. Pom-Op switches: Acceleration observed in April (best month for new commercial starts); majority of switches from Nexviazyme as patients reach ~2-year window .
  • DMX-200 differentiation: Downstream CCR2 signaling blockade avoids MCP-1 rebound; FDA aligned on proteinuria for full approval; interim analysis timeline tied to PARASOL dataset work (3–6 months) and subsequent FDA meeting .
  • FX policy: No hedging program; ±1% USD move ≈ ~$4M revenue impact, highlighting reporting volatility .

Estimates Context

Metric (Q1 2025)ActualConsensusSurprise ($)Surprise (%)# Estimates
Revenue ($USD)$125.249M $136.346M*-$11.097M*-8.1%*10*
Primary EPS (Normalized) ($)$0.03 -$0.0523*+$0.0823*N/M*8*

Values retrieved from S&P Global.*

Implications:

  • Revenue miss driven by ex-U.S. order timing and UK VPAG; sequential cadence expected to improve as new markets ramp in H2 .
  • EPS beat reflects high gross margin and disciplined OpEx; non-GAAP profitability achieved despite GAAP loss .

Key Takeaways for Investors

  • Demand indicators strong for both assets; expect sequential acceleration as Netherlands and other EU markets ramp, and U.S. switches increase into H2 — set up for back-half weighted year .
  • Guidance reset appears prudent: lower total and Pom-Op growth reflect timing and VPAG; watch Q2 patient starts and April trends to confirm reacceleration .
  • DMX-200 adds late-stage optionality with FDA-aligned endpoint; modest upfront limits balance sheet risk; monitor interim analysis and enrollment pace .
  • Margin durability remains high; 2025 mid-80s gross margin guided as Pom-Op COGS phases in; GAAP profitability in H2 still intact — potential valuation inflection .
  • FX remains a swing factor with ~60% ex-U.S. exposure; consider CER context when modeling reported results .
  • Near-term trading: Expect focus on VPAG headwind vs April/2H demand signals; beats/misses likely driven by cadence of EU launches and U.S. switch dynamics .
  • Medium-term thesis: Two commercial assets with expanding labels/geographies and a de-risked renal asset underpin double-digit growth path to ~$1B total sales by 2028 .