Executive Summary

FOLD delivered Q2 2025 revenue of $154.7M, +22% reported YoY (+18% CER), with Galafold $128.9M (+16% reported) and Pombiliti + Opfolda $25.8M (+63% reported). Currency was a ~$5M tailwind; ex-US represented ~58% of revenue .
Results exceeded S&P Global consensus: revenue $154.7M vs $146.7M (+$8.0M, +5.5%)* and non-GAAP EPS $0.01 vs -$0.12*, while GAAP EPS was -$0.08 (non-GAAP beat driven by stronger top line despite $30M DMX-200 upfront in opex)* .
Guidance reiterated: FY25 total revenue growth +15–22% CER; Galafold +10–15% CER; Pombiliti + Opfolda +50–65% CER; gross margin mid-80s; non-GAAP opex $380–$400M (incl. $30M DMX-200 upfront); positive GAAP net income in H2 2025 .
Strategic catalysts: Japan approval for Pombiliti + Opfolda (June), acceleration in new EU launches (Netherlands preferred therapy), and DMX-200 Phase 3 enrollment on track with FDA alignment on proteinuria endpoint; management reiterated a path to >$1B revenue by 2028 .

What Went Well and What Went Wrong

What Went Well

Strong top line and segment momentum: Q2 revenue +22% reported (Galafold +16% reported; Pombiliti + Opfolda +63% reported), with ex-US 58% mix and currency tailwind aiding reported growth .
Geographic and access wins for Pombiliti + Opfolda: regulatory approval in Japan; Netherlands selected as preferred treatment; six countries recorded first patient starts in H1 2025; up to 10 new launch countries in 2025 .
Management conviction and execution: “seventeenth consecutive quarter of double-digit gains at CER,” reiteration of H2 GAAP profitability; CEO: “firmly positioned to reach GAAP profitability in the second half of 2025” .

What Went Wrong

Higher operating expenses: GAAP opex +48% YoY to $148.9M (non-GAAP +56% to $127.8M), including the $30M DMX-200 U.S. licensing upfront .
GAAP EPS negative: -$0.08 vs -$0.05 YoY, despite non-GAAP profitability; CFO noted GAAP would have been positive excluding the $30M payment .
Sequential non-GAAP EPS softness: $0.01 in Q2 vs $0.03 in Q1 as the company absorbed higher opex and began transitioning to recognizing Pombiliti + Opfolda COGS in H2, with gross margin guided to mid-80s for FY25 .

Financial Results

Summary financials vs prior year and prior quarter

Metric	Q2 2024	Q1 2025	Q2 2025
Total Revenue ($M)	$126.669	$125.249	$154.688
GAAP EPS ($)	$(0.05)	$(0.07)	$(0.08)
Non-GAAP EPS ($)	$0.06	$0.03	$0.01
COGS % of Sales	9% (CFO)	~9.3% (derived from table)	10% (CFO)

Notes: Q2 2025 CER growth +18%; currency tailwind ~$5M .

Segment revenue breakdown (quarterly)

Segment ($M)	Q4 2024	Q1 2025	Q2 2025
Galafold	$127.5	$104.244	$128.872
Pombiliti + Opfolda	$22.209	$21.005	$25.816
Total Net Product Revenue	$149.706	$125.249	$154.688

KPIs and other operating metrics

Ex-US revenue mix: 58% of Q2 total; U.S. 42% .
Galafold market share in treated amenable Fabry: >69% global .
Cash, cash equivalents, and marketable securities: $231.0M at 6/30/25 .
Compliance/adherence: company targets >90% for both products (narrative) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue Growth (CER)	FY 2025	15%–22% (updated May 1, 2025)	15%–22% (reiterated Jul 31, 2025)	Maintained
Galafold Revenue Growth (CER)	FY 2025	10%–15% (updated May 1, 2025)	10%–15% (reiterated Jul 31, 2025)	Maintained
Pombiliti + Opfolda Growth (CER)	FY 2025	50%–65% (lowered May 1, 2025 from 65%–85%)	50%–65% (reiterated Jul 31, 2025)	Maintained vs Q1 (Lowered vs initial FY guide)
Gross Margin	FY 2025	Mid-80%	Mid-80%	Maintained
Non-GAAP Operating Expenses	FY 2025	$380M–$400M (incl. $30M DMX-200 upfront)	$380M–$400M (incl. $30M DMX-200 upfront)	Maintained
GAAP Net Income	FY 2025	Positive during H2 2025	Positive during H2 2025	Maintained

Context: Initial FY25 guidance on Feb 19, 2025 was Total +17–24% CER and P+O +65–85% CER; these were reduced on May 1 and reiterated on July 31 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4’24)	Previous Mentions (Q1’25)	Current Period (Q2’25)	Trend
Supply chain/tariffs/manufacturing	FY25 guide given; building inventory; not detailed on tariffs	Onshoring Pombiliti drug product with Sharp (U.S.)	No material 2025 tariff P&L impact; Ireland DS to enter EU supply H2’25 and U.S. in 2026; diversified supply incl. China/Leverkusen/Sharp	Improving resilience
Product performance (Galafold)	FY24 Galafold $458.1M (+18%)	Q1 demand strong but UK VPAG rebate/order timing weighed on revenue; reiterated +10–15% CER	Q2 revenue $128.9M (+12% CER); 13% YoY patient growth; >69% share	Accelerating after Q1 noise
Product performance (P+O)	FY24 $70.2M; ramp in US/EU; more reimbursements	Updated FY25 growth to +50–65% CER; Netherlands preferred treatment	Q2 $25.8M (+58% CER); 11 countries revenue; 6 new H1 starts; Japan approval	Broadening adoption
Regulatory/Access	Reimbursement wins: Italy, Sweden, Switzerland, Czech Republic, Netherlands; AU approval	Canada & Australia approvals; up to 10 new launch countries in 2025	Japan approval; Netherlands center actively transitioning patients; up to 10 launch countries in 2025	Expanding
R&D execution	—	Licensed DMX-200 U.S. rights (Phase 3)	ACTION3 >75% enrolled; FDA alignment on proteinuria primary; next FDA meeting planned	De-risking path
Legal/IP (Galafold)	—	—	Confident in IP vs Aurobindo; Teva settlement supportive; expect typical pathway to settlement	Supportive

Management Commentary

CEO: “We delivered strong second quarter growth of 18%… seventeenth consecutive quarter of double-digit gains at CER… firmly positioned to reach GAAP profitability in the second half of 2025… anticipate exceeding $1 billion in total revenue in 2028” .
CFO: “Excluding the $30 million upfront payment related to the DMX-200 agreement, we would have delivered positive GAAP net income for the quarter” .
CBO on P+O: “Q2 showed strong sales growth… record levels of patient demand… launched into five new markets in Q2… Japan approval and Netherlands preferred status will be key drivers” .
CDO on DMX-200: “FDA alignment on proteinuria as the primary endpoint… ACTION3 enrollment >75%… positioned to be a meaningful advancement for FSGS patients” .

Q&A Highlights

Supply chain/tariffs: All P+O material needed for 2025 commercial/clinical use already in U.S.; no material tariff impact in 2025; Ireland DS to enter EU supply in H2’25 and U.S. next year; diversified global manufacturing footprint (incl. Sharp U.S. DP) .
IP litigation: Confident in Galafold IP; Teva settlement strengthens position vs remaining litigants; most such cases settle over time .
P+O switches: Majority of new U.S. patients now switching from Nexviazyme; physicians consider biomarkers, 6MWD, FVC, muscle strength, QoL; earlier switches often in declining/severe patients; proactive switching expected as evidence grows .
DMX-200 regulatory: FDA minutes confirmed proteinuria primary endpoint; AdCom outcome on a different product (FILSPARI) seen as informative either way; ACTION3 LPI by YE25 and 2-year topline by 2027 .
Geographic ramp: Strong performance in UK, Germany, Spain; Sweden with disproportionate share; Italy launching; four more countries expected in 2H (incl. Japan) .

Estimates Context

Metric	Q2 2025 Actual	Q2 2025 Consensus*	Surprise
Revenue ($M)	$154.688	$146.681*	+$8.007 (+5.5%)
Primary (Non-GAAP) EPS ($)	$0.01	$(0.12)*	+$0.13

Values marked with * retrieved from S&P Global.
Implications: Revenue beat driven by strong Galafold momentum and accelerating P+O adoption with a currency tailwind . EPS outperformance versus negative consensus occurred despite the $30M DMX-200 upfront expensed in Q2, underscoring operating leverage as the commercial base scales .

Key Takeaways for Investors

Beat/raise check: Clear top-line and non-GAAP EPS beat vs consensus; guidance reiterated across all metrics, maintaining H2 GAAP profitability target .
Galafold steady compounding: High share in amenable Fabry, 13% YoY patient growth, and expanding diagnosis/access support multi-year growth .
P+O entering broader adoption phase: Access wins (Netherlands preferred), Japan approval, and multiple new EU launches support sustained growth into 2H and 2026 .
Margin trajectory: FY25 gross margin guided mid-80s as P+O COGS recognition normalizes in H2; Q2 COGS ~10% of sales vs 9% YoY .
Optionality from DMX-200: Late-stage FSGS asset with FDA-aligned endpoint and strong enrollment could add medium-term pipeline value without near-term development spend burden .
Risk watch: IP litigation ongoing (Galafold), UK VPAG-like dynamics, and execution on manufacturing diversification; management actions aim to mitigate .
Trading setup: Near-term catalysts include continued P+O country launches and access updates, progress on ACTION3, and delivery of H2 GAAP profitability; positive estimate revisions likely on revenue/EPS given beats and momentum .

Appendix: Additional Detail Tables

Revenue by product vs prior year (YoY)

Metric	Q2 2024	Q2 2025	YoY
Galafold ($M)	$110.817	$128.872	+16% reported; +12% CER
P+O ($M)	$15.852	$25.816	+63% reported; +58% CER
Total ($M)	$126.669	$154.688	+22% reported; +18% CER

Income statement line items (selected)

Metric ($M)	Q2 2024	Q2 2025
Net Product Sales	$126.669	$154.688
Cost of Goods Sold	$11.261	$15.217
Gross Profit	$115.408	$139.471
GAAP Operating Expenses	$100.441	$148.945 (incl. $30M DMX-200 upfront)
GAAP Net Income (Loss)	$(15.697)	$(24.420)
Non-GAAP Net Income	$18.487	$1.932

Balance sheet highlights

Cash, cash equivalents, and marketable securities: $231.0M at 6/30/2025 vs $249.9M at 12/31/2024 .
Long-term debt: $391.3M at 6/30/2025 .

Footnote: Values marked with * retrieved from S&P Global.

AMICUS THERAPEUTICS, INC. (FOLD)·Q2 2025 Earnings Summary