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AMICUS THERAPEUTICS, INC. (FOLD)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 delivered double‑digit growth and first GAAP profitability of 2025: revenue $169.1M (+19% reported; +17% CER) and GAAP EPS $0.06; non‑GAAP EPS $0.17; ex‑US accounted for 58% of revenue and FX tailwind was ~+$4M .
  • Both franchises grew: Galafold $138.3M (+15% YoY reported; +12% CER) on record new patient starts; Pombiliti + Opfolda $30.7M (+45% reported; +42% CER) with broadening reimbursement and launches (e.g., Japan) .
  • Guidance reiterated: 2025 total revenue growth +15–22% (CER); Galafold +10–15%; Pombiliti + Opfolda +50–65%; gross margin mid‑80s; non‑GAAP OpEx $380–$400M; positive GAAP net income in H2 2025 .
  • Key catalysts/stock narrative: sustained double‑digit growth with profitability inflection, accelerating Pombiliti + Opfolda adoption and country adds, and late‑stage DMX‑200 progress toward full enrollment by year‑end (U.S. rights in‑licensed) .

What Went Well and What Went Wrong

What Went Well

  • Record commercial demand: “strongest quarter ever for new commercial demand for both Galafold and Pombiliti + Opfolda,” with Galafold patient demand +13% YoY and rising naïve starts mix (~65%) .
  • Profitability and cash generation: first positive GAAP net income in 2025 ($17.3M) and cash/marketable securities increased by $32.8M Q/Q to $263.8M .
  • Evidence and market access momentum for Pompe: 4‑year PROPEL OLE data showed stability/improvement on muscle function/strength/biomarkers; reimbursement/launch progress including Japan and 15 reimbursed countries YTD .

What Went Wrong

  • Gross margin mixed sequentially: gross profit margin was ~88.5% in Q3 vs ~90.2% in Q2 as COGS increased to 12% of sales due to hybrid inventory cost dynamics for Pombiliti + Opfolda through Q4 .
  • OpEx drifted higher: non‑GAAP operating expenses rose to $95.4M (+15% YoY), and management guided to the high end of the $380–$400M range for 2025 .
  • Prior UK VPAG pressure and ordering patterns earlier in 2025 underscore sensitivity to ex‑US market mechanics, though Q3 benefited from FX and sustained demand .

Financial Results

Summary P&L vs prior periods

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Product Sales ($M)141.5 125.2 154.7 169.1
Gross Profit ($M)128.2 113.6 139.5 149.6
Gross Margin (%)90.6% (128.2/141.5) 90.7% (113.6/125.2) 90.2% (139.5/154.7) 88.5% (149.6/169.1)
GAAP Net Income ($M)(6.7) (21.7) (24.4) 17.3
GAAP EPS ($)(0.02) (0.07) (0.08) 0.06
Non‑GAAP Net Income ($M)30.8 9.0 1.9 54.2
Non‑GAAP EPS (diluted) ($)0.10 0.03 0.01 0.17

Notes: CFO cited COGS at 12% of sales in Q3 (vs 9% in Q3 2024) and reiterated non‑linearity of early profitability .

Segment/Product Revenue

Product Revenue ($M)Q3 2024Q1 2025Q2 2025Q3 2025
Galafold120.4 104.2 128.9 138.3
Pombiliti + Opfolda21.1 21.0 25.8 30.7
Total Net Product Revenue141.5 125.2 154.7 169.1

KPIs and Mix

  • Ex‑US revenue mix: 58% of total in Q3; U.S. 42% .
  • FX impact: ~+$4M tailwind in Q3 .
  • Galafold: +13% YoY patient demand; ~65% naïve / 35% switch mix; ~69% share of treated amenable patients .
  • Pombiliti + Opfolda: strong adoption; U.S. ~43% of Q3 franchise revenue; 15 reimbursed countries YTD; first commercial patients in Japan .

Actuals vs S&P Global Consensus (Q3 2025)

MetricConsensusActualSurprise
Revenue ($M)165.7*169.1 +$3.4M (≈+2.1%)*
Non‑GAAP EPS (Primary EPS) ($)0.039*0.17 +$0.13*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue Growth (CER)FY2025+17% to +24% (Q1 prior) +15% to +22% (reiterated in Q2/Q3) Lowered in Q1; maintained Q2/Q3
Galafold Revenue Growth (CER)FY2025+10% to +15% +10% to +15% Maintained
Pombiliti + Opfolda Revenue Growth (CER)FY2025+65% to +85% (prior) → +50% to +65% (Q1 update) +50% to +65% Lowered in Q1; maintained Q2/Q3
Gross MarginFY2025Mid‑80% Mid‑80% Maintained
Non‑GAAP Operating ExpensesFY2025$350–$370M (prior) → $380–$400M (Q1 update) $380–$400M (at high end) Raised in Q1; maintained
GAAP Net Income2H 2025Positive Positive (achieved Q3; reiterated for 2H) Maintained; achieved Q3

Earnings Call Themes & Trends

TopicQ1 2025 (Q‑2)Q2 2025 (Q‑1)Q3 2025 (Current)Trend
Product performanceGalafold demand strong; VPAG headwind; P+O guidance reset to +50–65% CER Galafold +12% CER; P+O +58% CER; “highest demand quarter since launch” Record demand both products; Galafold demand +13% YoY; U.S. ~43% of P+O Strengthening
Regional mix~60% ex‑US revs FY24 baseline; new country ramps ahead New launches contributed; reimbursement broadening 58% ex‑US; first patients in Japan Ex‑US remains key
Supply chain/ManufacturingAdded U.S. drug product site (Sharp Sterile) –EMA approved Dundalk, Ireland site for Pombiliti De‑risking footprint
Regulatory/AccessCanada/Australia approvals; Netherlands preferred therapy Japan approval (June) Multiple new reimbursement deals incl. Japan/Belgium; 15 reimbursed countries YTD Expanding access
R&D executionIn‑licensed DMX‑200 (U.S. rights); ACTION3 progressing ACTION3 on track to complete enrollment by year‑end >90% enrolled; FDA alignment on proteinuria endpoint; next FDA meeting planned Advancing toward key readouts
Macro/Tariffs/Policy“Limited tariff impact” and supply chain diversification –Biosecure 2.0 not a concern; friend‑shored Ireland supply highlighted Managed risk

Management Commentary

  • CEO opening: “another great quarter… strong revenue growth, GAAP profitability… strongest quarter ever for new commercial demand for both Galafold and Pombiliti and Opfolda… on track to deliver combined sales of $1 billion in 2028” .
  • Commercial lead on Galafold: “revenue reached $138.3 million… underlying growth in patient demand increased by 13%… ~69% share of treated amenable patients” .
  • CFO on profitability and mix: “total revenue of $169.1 million… COGS 12%… positive GAAP net income… cash… increased by $32.8 million during the third quarter” .
  • Development on Pombiliti + Opfolda evidence: “new four‑year data from PROPEL OLE… durability… stability or improvements in key endpoints” .

Q&A Highlights

  • Pombiliti adoption drivers: Real‑world evidence (including U.K. comparisons) and accumulating case studies are influencing physician switches; pediatric label expansions targeted with adolescent LOPD submission expected “mid‑next year” .
  • U.S. Pombiliti momentum and 2026 trajectory: Q3 saw largest ever net commercial demand; faster reimbursement timelines; expanding sites/prescribers; Netherlands switches progressing with expectation for substantial share .
  • Galafold patient adds: Growth led by core countries with standard‑of‑care positioning for newly diagnosed amenable patients; underdiagnosis remains large opportunity .
  • Policy/biosecurity: Management expects stable U.S. supply given Ireland manufacturing approval and friend‑shoring; not concerned about evolving Biosecure 2.0 proposals .
  • DMX‑200 biomarkers: Higher MCP‑1 levels correlated with greater proteinuria response in Phase 2; Phase 3 measures MCP‑1 prospectively without entry threshold .

Estimates Context

  • Q3 2025 results vs S&P Global consensus: Revenue $169.1M vs $165.7M* (≈+2.1%); non‑GAAP EPS (Primary EPS) $0.17 vs $0.039* (material beat). Management said full‑year revenues are “trending in line with full year consensus numbers” .
  • Implications: Consensus likely to move higher on P&L leverage and Pombiliti momentum; FX tailwind (~$4M Q3) normalizes, while COGS mix normalizes after Q4 per inventory dynamics .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • The growth/profitability flywheel is turning: positive GAAP earnings with strong non‑GAAP EPS and cash generation; management expects positive GAAP net income for 2H .
  • Galafold remains a durable engine, with rising naïve share and high adherence, supported by underdiagnosis tailwinds and >60% ex‑US exposure .
  • Pombiliti + Opfolda adoption is accelerating with expanding reimbursement (incl. Japan) and real‑world evidence—setting up multi‑year contribution and potential peak leadership (>50% share over time per management) .
  • 2025 guidance intact across revenue/gross margin/OpEx, de‑risking near‑term outlook; watch for Q4 dynamics as Pombiliti COGS fully expensed through year‑end .
  • Pipeline option value: DMX‑200 Phase 3 ACTION3 nearing full enrollment with FDA endpoint alignment; additional updates/meetings in coming quarters are catalysts .
  • Supply chain resiliency improved via EMA‑approved Ireland site and U.S. drug product capacity, mitigating policy/tariff risks .
  • Near‑term trading skew: estimate revisions positive on EPS/revenue beats and reiterated guide; monitor FX and Q4 COGS cadence, plus cadence of Japan and other new market ramps .