0001178879 FALSE--12-31 2025 Q3 475 339 494 162 xbrli:shares iso4217:USD iso4217:USD xbrli:shares fold:segment xbrli:pure 0001178879 2025-01-01 2025-09-30 0001178879 2025-10-24 0001178879 2025-09-30 0001178879 2024-12-31 0001178879 2025-07-01 2025-09-30 0001178879 2024-07-01 2024-09-30 0001178879 2024-01-01 2024-09-30 0001178879 us-gaap:CommonStockMember 2025-06-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2025-06-30 0001178879 us-gaap:TreasuryStockCommonMember 2025-06-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-06-30 0001178879 us-gaap:RetainedEarningsMember 2025-06-30 0001178879 2025-06-30 0001178879 us-gaap:CommonStockMember 2025-07-01 2025-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2025-07-01 2025-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-07-01 2025-09-30 0001178879 us-gaap:RetainedEarningsMember 2025-07-01 2025-09-30 0001178879 us-gaap:CommonStockMember 2025-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2025-09-30 0001178879 us-gaap:TreasuryStockCommonMember 2025-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-09-30 0001178879 us-gaap:RetainedEarningsMember 2025-09-30 0001178879 us-gaap:CommonStockMember 2024-12-31 0001178879 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001178879 us-gaap:WarrantMember 2024-12-31 0001178879 us-gaap:TreasuryStockCommonMember 2024-12-31 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-12-31 0001178879 us-gaap:RetainedEarningsMember 2024-12-31 0001178879 us-gaap:CommonStockMember 2025-01-01 2025-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2025-01-01 2025-09-30 0001178879 us-gaap:WarrantMember 2025-01-01 2025-09-30 0001178879 us-gaap:TreasuryStockCommonMember 2025-01-01 2025-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-01-01 2025-09-30 0001178879 us-gaap:RetainedEarningsMember 2025-01-01 2025-09-30 0001178879 us-gaap:WarrantMember 2025-09-30 0001178879 us-gaap:CommonStockMember 2024-06-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2024-06-30 0001178879 us-gaap:WarrantMember 2024-06-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-06-30 0001178879 us-gaap:RetainedEarningsMember 2024-06-30 0001178879 2024-06-30 0001178879 us-gaap:CommonStockMember 2024-07-01 2024-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2024-07-01 2024-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-07-01 2024-09-30 0001178879 us-gaap:RetainedEarningsMember 2024-07-01 2024-09-30 0001178879 us-gaap:CommonStockMember 2024-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2024-09-30 0001178879 us-gaap:WarrantMember 2024-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-09-30 0001178879 us-gaap:RetainedEarningsMember 2024-09-30 0001178879 2024-09-30 0001178879 us-gaap:CommonStockMember 2023-12-31 0001178879 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001178879 us-gaap:WarrantMember 2023-12-31 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-12-31 0001178879 us-gaap:RetainedEarningsMember 2023-12-31 0001178879 2023-12-31 0001178879 us-gaap:CommonStockMember 2024-01-01 2024-09-30 0001178879 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-09-30 0001178879 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-01-01 2024-09-30 0001178879 us-gaap:RetainedEarningsMember 2024-01-01 2024-09-30 0001178879 fold:GalafoldMember country:US 2025-07-01 2025-09-30 0001178879 fold:GalafoldMember country:US 2024-07-01 2024-09-30 0001178879 fold:GalafoldMember country:US 2025-01-01 2025-09-30 0001178879 fold:GalafoldMember country:US 2024-01-01 2024-09-30 0001178879 fold:GalafoldMember us-gaap:NonUsMember 2025-07-01 2025-09-30 0001178879 fold:GalafoldMember us-gaap:NonUsMember 2024-07-01 2024-09-30 0001178879 fold:GalafoldMember us-gaap:NonUsMember 2025-01-01 2025-09-30 0001178879 fold:GalafoldMember us-gaap:NonUsMember 2024-01-01 2024-09-30 0001178879 fold:GalafoldMember 2025-07-01 2025-09-30 0001178879 fold:GalafoldMember 2024-07-01 2024-09-30 0001178879 fold:GalafoldMember 2025-01-01 2025-09-30 0001178879 fold:GalafoldMember 2024-01-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember country:US 2025-07-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember country:US 2024-07-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember country:US 2025-01-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember country:US 2024-01-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember us-gaap:NonUsMember 2025-07-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember us-gaap:NonUsMember 2024-07-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember us-gaap:NonUsMember 2025-01-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember us-gaap:NonUsMember 2024-01-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember 2025-07-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember 2024-07-01 2024-09-30 0001178879 fold:PombilitiOpfoldaMember 2025-01-01 2025-09-30 0001178879 fold:PombilitiOpfoldaMember 2024-01-01 2024-09-30 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2025-09-30 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember 2025-09-30 0001178879 us-gaap:CorporateDebtSecuritiesMember 2025-09-30 0001178879 us-gaap:MoneyMarketFundsMember 2025-09-30 0001178879 us-gaap:CertificatesOfDepositMember 2025-09-30 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember 2024-12-31 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2024-12-31 0001178879 us-gaap:CorporateDebtSecuritiesMember 2024-12-31 0001178879 us-gaap:MoneyMarketFundsMember 2024-12-31 0001178879 us-gaap:CertificatesOfDepositMember 2024-12-31 0001178879 fold:SeniorSecuredTermLoanDue2029Member us-gaap:SeniorLoansMember 2025-09-30 0001178879 fold:SeniorSecuredTermLoanDue2029Member us-gaap:SeniorLoansMember 2024-12-31 0001178879 fold:DimerixLimitedMember us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember 2025-04-30 2025-04-30 0001178879 fold:SuccessBasedDevelopmentAndRegulatoryMilestoneMember us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember fold:DimerixLimitedMember 2025-04-30 0001178879 fold:RegulatoryMilestoneMember us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember fold:DimerixLimitedMember 2025-04-30 0001178879 fold:CommercialMilestoneMember us-gaap:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementMember fold:DimerixLimitedMember 2025-04-30 0001178879 fold:A2025EquityPlanMember 2025-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2025-07-01 2025-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2024-07-01 2024-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2025-01-01 2025-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2025-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2024-12-31 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2025-09-30 0001178879 us-gaap:ResearchAndDevelopmentExpenseMember 2025-07-01 2025-09-30 0001178879 us-gaap:ResearchAndDevelopmentExpenseMember 2024-07-01 2024-09-30 0001178879 us-gaap:ResearchAndDevelopmentExpenseMember 2025-01-01 2025-09-30 0001178879 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-09-30 0001178879 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2025-07-01 2025-09-30 0001178879 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2024-07-01 2024-09-30 0001178879 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2025-01-01 2025-09-30 0001178879 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2024-01-01 2024-09-30 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member 2025-09-30 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member 2025-09-30 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember us-gaap:FairValueInputsLevel1Member 2025-09-30 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember us-gaap:FairValueInputsLevel2Member 2025-09-30 0001178879 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member 2025-09-30 0001178879 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member 2025-09-30 0001178879 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member 2025-09-30 0001178879 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel2Member 2025-09-30 0001178879 us-gaap:FairValueInputsLevel1Member 2025-09-30 0001178879 us-gaap:FairValueInputsLevel2Member 2025-09-30 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001178879 us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001178879 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001178879 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001178879 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001178879 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001178879 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001178879 us-gaap:FairValueInputsLevel1Member 2024-12-31 0001178879 us-gaap:FairValueInputsLevel2Member 2024-12-31 0001178879 us-gaap:EmployeeStockOptionMember 2025-07-01 2025-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2024-07-01 2024-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2025-01-01 2025-09-30 0001178879 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2025-07-01 2025-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2024-07-01 2024-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-09-30 0001178879 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-09-30 0001178879 fold:BradleyCampbellMember 2025-07-01 2025-09-30 0001178879 fold:DavidClarkMember 2025-07-01 2025-09-30 0001178879 fold:EllenRosenbergMember 2025-07-01 2025-09-30 0001178879 fold:JeffreyCastelliMember 2025-07-01 2025-09-30 0001178879 fold:JeffreyCastelliMember 2025-09-30 0001178879 fold:BradleyCampbellMember 2025-09-30 0001178879 fold:JeffreyCastelliMember fold:JeffreyCastelliTradingArrangementStockOptionsMember 2025-09-30 0001178879 fold:JeffreyCastelliMember fold:JeffreyCastelliTradingArrangementCommonStockUnderlyingStockOptionsMember 2025-09-30 0001178879 fold:JeffreyCastelliMember fold:JeffreyCastelliTradingArrangementCommonStockMember 2025-09-30

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number 001-33497
Amicus Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)

Delaware |  | 71-0869350
(State or Other Jurisdiction of |  | (I.R.S. Employer
Incorporation or Organization) |  | Identification Number)
47 Hulfish Street, Princeton, NJ |  | 08542
(Address of Principal Executive Offices) |  | (Zip Code)
(609) | 662-2000
(Registrant's Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class | Trading Symbol(s) | Name of each exchange on which registered
Common Stock, par value $0.01 per share | FOLD | NASDAQ Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer | ☒ |  | Accelerated filer | ☐
Non-accelerated filer | ☐ |  | Smaller reporting company | ☐
|  |  | Emerging growth company | ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the registrant's common stock, $0.01 par value per share, as of October 24, 2025 was 308,533,548 shares.

AMICUS THERAPEUTICS, INC.
Form 10-Q for the Quarterly Period Ended September 30, 2025

| Page
PART I. FINANCIAL INFORMATION |  | 3
| Item 1. | Consolidated Financial Statements and Notes (unaudited) | 3
|  | Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 | 3
|  | Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025 and 2024 | 4
|  | Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2025 and 2024 | 5
|  | Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2025 and 2024 | 6
|  | Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 | 8
|  | Notes to Consolidated Financial Statements | 9
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 19
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 27
| Item 4. | Controls and Procedures | 27
PART II. OTHER INFORMATION | 27
| Item 1. | Legal Proceedings | 27
| Item 1A. | Risk Factors | 27
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 28
| Item 3. | Defaults Upon Senior Securities | 28
| Item 4. | Mine Safety Disclosures | 28
| Item 5. | Other Information | 29
| Item 6. | Exhibits | 30
SIGNATURES | 31

i

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks, uncertainties, and assumptions. Forward-looking statements are all statements, other than statements of historical facts, that discuss our current expectation and projections relating to our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management. These statements may be preceded by, followed by or include the words "aim," "anticipate," "believe," "can," "could," "estimate," "expect," "forecast," "intend," "likely," "may," "might," "outlook," "plan," "potential," "predict," "project," "seek," "should," "will," "would," the negatives or plurals thereof, and other words and terms of similar meaning, although not all forward-looking statements contain these identifying words.
We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct. You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements:
•the scope, progress, results and costs of clinical trials for our drug candidates;
•the cost of manufacturing drug supply for our commercial, clinical and preclinical studies, including the cost of manufacturing Pombiliti® (also referred to as "ATB200" or "cipaglucosidase alfa");
•the future results of preclinical research and subsequent clinical trials for pipeline candidates we may identify from time to time, including our ability to obtain regulatory approvals and commercialize such therapies;
•the costs, timing, and outcome of regulatory review of our product candidates;
•any changes in regulatory standards relating to the review of our product candidates;
•any changes in laws, rules or regulations, including the imposition of tariffs or other trade restrictions, affecting our ability to manufacture, transport, test, develop, or commercialize our products, including Galafold®, Pombiliti® + Opfolda®, or our product candidates;
•the costs of commercialization activities, including product marketing, sales, and distribution;
•the emergence of competing technologies and other adverse market developments;
•the estimates regarding the potential market opportunity for our products and product candidates;
•our ability to successfully commercialize Galafold® (also referred to as "migalastat HCl");
•our ability to successfully commercialize Pombiliti® + Opfolda® in the E.U., U.K., and U.S., and elsewhere, if regulatory applications are approved;
•our ability to manufacture or supply sufficient clinical or commercial products, including Galafold® and Pombiliti® + Opfolda®;
•our ability to obtain reimbursement for Galafold® and Pombiliti® + Opfolda®;
•our ability to satisfy post-marketing commitments or requirements for continued regulatory approval of Galafold® and Pombiliti® + Opfolda®;
•our ability to obtain market acceptance of Galafold® and Pombiliti® + Opfolda®, or any other product developed or acquired that has received regulatory approval;
•the costs of preparing, filing, and prosecuting patent applications and maintaining, enforcing, and defending intellectual property-related claims, including Hatch-Waxman litigation;
•the impact of litigation that has been or may be brought against us or of litigation that we are pursuing or may pursue against others, including Hatch-Waxman litigation;
•the extent to which we acquire or invest in businesses, products, and technologies;
•our ability to successfully integrate acquired products and technologies into our business, or successfully divest or license existing products and technologies from our business, including the possibility that the expected benefits of the transactions will not be fully realized by us or may take longer to realize than expected;
•our ability to establish licensing agreements, collaborations, partnerships or other similar arrangements and to obtain milestone, royalty, or other economic benefits from any such collaborators;
1

•the costs associated with, and our ability to comply with, emerging sustainability standards, including climate reporting requirements at the local, state and national levels, especially abroad;
•our ability to successfully protect our information technology systems and maintain our global operations and supply chain without interruption;
•our ability to accurately forecast revenue, operating expenditures, or other metrics impacting profitability;
•fluctuations in foreign currency exchange rates; and
•changes in accounting standards.
In light of these risks and uncertainties, we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in Part I Item 1A — Risk Factors of the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Those factors and the other risk factors described herein are not necessarily all of the important factors that could cause actual results or developments to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results. Our forward-looking statements do not reflect the potential impact of any future collaborations, alliances, business combinations, partnerships, strategic out-licensing of certain assets, the acquisition of preclinical-stage, clinical-stage, marketed products or platform technologies or other investments we may make. Consequently, there can be no assurance that actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Given these uncertainties, investors are cautioned not to place undue reliance on such forward-looking statements.
You should read this Quarterly Report on Form 10-Q in conjunction with our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (including the documents incorporated by reference therein) completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements speak only as of the date of this report. We undertake no obligation, and specifically decline any obligation, to publicly update or revise any forward-looking statements, even if experience or future developments make it clear that projected results expressed or implied in such statements will not be realized, except as may be required by law.
2

PART I. FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS AND NOTES (UNAUDITED)
Amicus Therapeutics, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)

| September 30, 2025 |  | December 31, 2024
Assets |  |  |
Current assets: |  |  |
Cash and cash equivalents | $ | 190,553 |  |  | $ | 213,752 |
Investments in marketable securities | 73,290 |  |  | 36,194 |
Accounts receivable | 113,838 |  |  | 101,099 |
Inventories | 177,928 |  |  | 118,782 |
Prepaid expenses and other current assets | 38,457 |  |  | 34,909 |
Total current assets | 594,066 |  |  | 504,736 |
Operating lease right-of-use assets, net | 21,549 |  |  | 22,278 |
Property and equipment, less accumulated depreciation of $31,271 and $28,775 at September 30, 2025 and December 31, 2024, respectively | 27,759 |  |  | 29,383 |
Intangible assets, less accumulated amortization of $8,257 and $5,802 at September 30, 2025 and December 31, 2024, respectively | 14,743 |  |  | 17,198 |
Goodwill | 197,797 |  |  | 197,797 |
Other non-current assets | 12,897 |  |  | 13,641 |
Total Assets | $ | 868,811 |  |  | $ | 785,033 |
Liabilities and Stockholders’ Equity |  |  |
Current liabilities: |  |  |
Accounts payable | $ | 19,103 |  |  | $ | 12,947 |
Accrued expenses and other current liabilities | 171,165 |  |  | 127,300 |
Operating lease liabilities | 8,662 |  |  | 8,455 |
Total current liabilities | 198,930 |  |  | 148,702 |
Long-term debt | 391,985 |  |  | 390,111 |
Operating lease liabilities | 42,174 |  |  | 45,078 |
Other non-current liabilities | 5,298 |  |  | 7,097 |
Total liabilities | 638,387 |  |  | 590,988 |
Commitments and contingencies |  |  |
Stockholders’ equity: |  |  |
Common stock, $0.01 par value, 500,000,000 shares authorized, 308,499,614 and 299,041,653 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | 3,017 |  |  | 2,944 |
Common stock in treasury, at cost; 7,390 shares as of September 30, 2025 | (71) |  |  | — |
Additional paid-in capital | 2,973,625 |  |  | 2,926,115 |
Accumulated other comprehensive income (loss): |  |  |
Foreign currency translation adjustment | 22,886 |  |  | 5,302 |
Unrealized loss on available-for-sale securities | (53) |  |  | (207) |
Warrants | — |  |  | 71 |
Accumulated deficit | (2,768,980) |  |  | (2,740,180) |
Total stockholders’ equity | 230,424 |  |  | 194,045 |
Total Liabilities and Stockholders’ Equity | $ | 868,811 |  |  | $ | 785,033 |

See accompanying Notes to Consolidated Financial Statements
3

Amicus Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)

| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2025 |  | 2024 |  | 2025 |  | 2024
Net product sales | $ | 169,061 |  |  | $ | 141,517 |  |  | $ | 448,998 |  |  | $ | 378,589 |
Cost of goods sold | 19,467 |  |  | 13,279 |  |  | 46,382 |  |  | 38,107 |
Gross profit | 149,594 |  |  | 128,238 |  |  | 402,616 |  |  | 340,482 |
Operating expenses: |  |  |  |  |  |  |
Research and development | 23,415 |  |  | 26,160 |  |  | 112,102 |  |  | 79,172 |
Selling, general, and administrative | 90,036 |  |  | 75,106 |  |  | 266,406 |  |  | 236,711 |
Restructuring charges | — |  |  | 3,143 |  |  | — |  |  | 9,188 |
Loss on impairment of assets | — |  |  | — |  |  | 1,702 |  |  | — |
Depreciation and amortization | 1,874 |  |  | 2,170 |  |  | 5,563 |  |  | 6,506 |
Total operating expenses | 115,325 |  |  | 106,579 |  |  | 385,773 |  |  | 331,577 |
Income from operations | 34,269 |  |  | 21,659 |  |  | 16,843 |  |  | 8,905 |
Other expense: |  |  |  |  |  |  |
Interest income | 829 |  |  | 1,081 |  |  | 2,484 |  |  | 3,991 |
Interest expense | (11,711) |  |  | (12,692) |  |  | (34,731) |  |  | (37,640) |
Other income (expense) | 10,887 |  |  | (3,263) |  |  | 12,452 |  |  | (11,946) |
Income (loss) before income tax | 34,274 |  |  | 6,785 |  |  | (2,952) |  |  | (36,690) |
Income tax expense | (16,968) |  |  | (13,514) |  |  | (25,848) |  |  | (34,155) |
Net income (loss) attributable to common stockholders | $ | 17,306 |  |  | $ | (6,729) |  |  | $ | (28,800) |  |  | $ | (70,845) |
Net income (loss) attributable to common stockholders per common share — basic | $ | 0.06 |  |  | $ | (0.02) |  |  | $ | (0.09) |  |  | $ | (0.23) |
Net income (loss) attributable to common stockholders per common share — diluted | 0.06 |  |  | (0.02) |  |  | (0.09) |  |  | (0.23) |
Weighted-average common shares outstanding — basic | 308,468,423 |  | 304,690,596 |  | 308,139,134 |  | 303,792,479
Weighted-average common shares outstanding — diluted | 310,433,494 |  | 304,690,596 |  | 308,139,134 |  | 303,792,479

See accompanying Notes to Consolidated Financial Statements
4

Amicus Therapeutics, Inc.
Consolidated Statements of Comprehensive Income (Loss)
(Unaudited)
(in thousands)

| Three Months Ended September 30, |  | Nine Months Ended September 30,
| 2025 |  | 2024 |  | 2025 |  | 2024
Net income (loss) | $ | 17,306 |  |  | $ | (6,729) |  |  | $ | (28,800) |  |  | $ | (70,845) |
Other comprehensive (loss) income, net of tax: |  |  |  |  |  |  |
Foreign currency translation adjustment | (8,049) |  |  | 16,168 |  |  | 17,584 |  |  | 19,730 |
Unrealized gain on available-for-sale securities | 76 |  |  | 9 |  |  | 154 |  |  | — |
Other comprehensive (loss) income | (7,973) |  |  | 16,177 |  |  | 17,738 |  |  | 19,730 |
Comprehensive income (loss) | $ | 9,333 |  |  | $ | 9,448 |  |  | $ | (11,062) |  |  | $ | (51,115) |

See accompanying Notes to Consolidated Financial Statements
5

Amicus Therapeutics, Inc.
Consolidated Statements of Changes in Stockholders' Equity
(Unaudited)
(in thousands, except share amounts)

Three Months Ended September 30, 2025
| Common Stock |  | Additional Paid-In Capital |  | Treasury Stock |  | Other Comprehensive Income |  | Accumulated Deficit |  | Total Stockholders' Equity
| Shares |  | Amount | Shares |  | Amount
Balance at June 30, 2025 | 308,064,329 |  |  | $ | 3,016 |  |  | $ | 2,956,839 |  |  | 7,390 |  |  | $ | (71) |  |  | $ | 30,806 |  |  | $ | (2,786,286) |  |  | $ | 204,304 |
Stock options exercised, net | 60,004 |  |  | 1 |  |  | 338 |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 339 |
Vesting of restricted stock units, net of taxes | 375,281 |  |  | — |  |  | (1,641) |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (1,641) |
Stock-based compensation | — |  |  | — |  |  | 18,089 |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 18,089 |
Unrealized gain on available-for-sale securities | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 76 |  |  | — |  |  | 76 |
Foreign currency translation adjustment | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (8,049) |  |  | — |  |  | (8,049) |
Net income | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 17,306 |  |  | 17,306 |
Balance at September 30, 2025 | 308,499,614 |  |  | $ | 3,017 |  |  | $ | 2,973,625 |  |  | 7,390 |  |  | $ | (71) |  |  | $ | 22,833 |  |  | $ | (2,768,980) |  |  | $ | 230,424 |

Nine Months Ended September 30, 2025
| Common Stock |  | Additional Paid-In Capital |  | Warrants |  | Treasury Stock |  | Other Comprehensive Income |  | Accumulated Deficit |  | Total Stockholders' Equity
| Shares |  | Amount |  | Shares |  | Amount
Balance at December 31, 2024 | 299,041,653 |  |  | $ | 2,944 |  |  | $ | 2,926,115 |  |  | $ | 71 |  |  | — |  |  | $ | — |  |  | $ | 5,095 |  |  | $ | (2,740,180) |  |  | $ | 194,045 |
Stock options exercised, net | 79,448 |  |  | 2 |  |  | 482 |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 484 |
Vesting of restricted stock units, net of taxes | 2,256,298 |  |  | — |  |  | (13,863) |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (13,863) |
Stock-based compensation | — |  |  | — |  |  | 60,820 |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 60,820 |
Warrants exercised | 7,129,605 |  |  | 71 |  |  | — |  |  | (71) |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |
Treasury stock | (7,390) |  |  | — |  |  | 71 |  |  | — |  |  | 7,390 |  |  | (71) |  |  | — |  |  | — |  |  | — |
Unrealized gain on available-for-sale securities | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 154 |  |  | — |  |  | 154 |
Foreign currency translation adjustment | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | 17,584 |  |  | — |  |  | 17,584 |
Net loss | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (28,800) |  |  | (28,800) |
Balance at September 30, 2025 | 308,499,614 |  |  | $ | 3,017 |  |  | $ | 2,973,625 |  |  | $ | — |  |  | 7,390 |  |  | $ | (71) |  |  | $ | 22,833 |  |  | $ | (2,768,980) |  |  | $ | 230,424 |

6

Three Months Ended September 30, 2024
| Common Stock |  | Additional Paid-In Capital |  | Warrants |  | Other Comprehensive Income |  | Accumulated Deficit |  | Total Stockholders' Equity
| Shares |  | Amount |
Balance at June 30, 2024 | 296,428,877 |  |  | $ | 2,923 |  |  | $ | 2,868,925 |  |  | $ | 71 |  |  | $ | 8,794 |  |  | $ | (2,748,190) |  |  | $ | 132,523 |
Stock options exercised, net | 215,653 |  |  | 2 |  |  | 1,803 |  |  | — |  |  | — |  |  | — |  |  | 1,805 |
Vesting of restricted stock units, net of taxes | 354,273 |  |  | — |  |  | (2,792) |  |  | — |  |  | — |  |  | — |  |  | (2,792) |
Stock-based compensation | — |  |  | — |  |  | 18,688 |  |  | — |  |  | — |  |  | — |  |  | 18,688 |
Issuance of shares in connection with at-the-market offering, net of issuance costs | 1,692,291 |  |  | 17 |  |  | 19,136 |  |  |  |  |  |  |  |  | 19,153 |
Unrealized gain on available-for-sale securities | — |  |  | — |  |  | — |  |  | — |  |  | 9 |  |  | — |  |  | 9 |
Foreign currency translation adjustment | — |  |  | — |  |  | — |  |  | — |  |  | 16,168 |  |  | — |  |  | 16,168 |
Net loss | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (6,729) |  |  | (6,729) |
Balance at September 30, 2024 | 298,691,094 |  |  | $ | 2,942 |  |  | $ | 2,905,760 |  |  | $ | 71 |  |  | $ | 24,971 |  |  | $ | (2,754,919) |  |  | $ | 178,825 |

Nine Months Ended September 30, 2024
| Common Stock |  | Additional Paid-In Capital |  | Warrants |  | Other Comprehensive Income |  | Accumulated Deficit |  | Total Stockholders' Equity
| Shares |  | Amount |
Balance at December 31, 2023 | 293,594,209 |  |  | $ | 2,918 |  |  | $ | 2,836,018 |  |  | $ | 71 |  |  | $ | 5,241 |  |  | $ | (2,684,074) |  |  | $ | 160,174 |
Stock options exercised, net | 796,202 |  |  | 7 |  |  | 6,115 |  |  | — |  |  | — |  |  | — |  |  | 6,122 |
Vesting of restricted stock units, net of taxes | 2,608,392 |  |  | — |  |  | (21,197) |  |  | — |  |  | — |  |  | — |  |  | (21,197) |
Stock-based compensation | — |  |  | — |  |  | 65,688 |  |  | — |  |  | — |  |  | — |  |  | 65,688 |
Issuance of shares in connection with at-the-market offering, net of issuance costs | 1,692,291 |  |  | 17 |  |  | 19,136 |  |  |  |  |  |  |  |  | 19,153 |
Foreign currency translation adjustment | — |  |  | — |  |  | — |  |  | — |  |  | 19,730 |  |  | — |  |  | 19,730 |
Net loss | — |  |  | — |  |  | — |  |  | — |  |  | — |  |  | (70,845) |  |  | (70,845) |
Balance at September 30, 2024 | 298,691,094 |  |  | $ | 2,942 |  |  | $ | 2,905,760 |  |  | $ | 71 |  |  | $ | 24,971 |  |  | $ | (2,754,919) |  |  | $ | 178,825 |

See accompanying Notes to Consolidated Financial Statements
7

Amicus Therapeutics, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)

| Nine Months Ended September 30,
| 2025 |  | 2024
Operating activities |  |  |
Net loss | $ | (28,800) |  |  | $ | (70,845) |
Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
Amortization of debt discount and deferred financing | 1,894 |  |  | 1,665 |
Depreciation and amortization | 5,563 |  |  | 6,506 |
Stock-based compensation | 60,820 |  |  | 65,688 |
Foreign currency remeasurement loss | 7,208 |  |  | 15,167 |
Other | 3,134 |  |  | 7,048 |
Changes in operating assets and liabilities: |  |  |
Accounts receivable | (5,246) |  |  | (9,090) |
Inventories | (67,187) |  |  | (61,632) |
Prepaid expenses and other current assets | (787) |  |  | 28,216 |
Accounts payable, accrued expenses, and other current liabilities | 44,634 |  |  | (11,483) |
Other non-current assets and liabilities | (4,341) |  |  | (1,215) |
Net cash provided by (used in) operating activities | $ | 16,892 |  |  | $ | (29,975) |
Investing activities |  |  |
Sale and redemption of marketable securities | 34,412 |  |  | 101,875 |
Purchases of marketable securities | (71,353) |  |  | (78,778) |
Capital expenditures | (2,997) |  |  | (3,265) |
Net cash (used in) provided by investing activities | $ | (39,938) |  |  | $ | 19,832 |
Financing activities |  |  |
Payment of finance leases | (40) |  |  | (54) |
Withholding taxes paid on vested restricted stock units | (13,863) |  |  | (21,197) |
Proceeds from stock options exercised, net | 484 |  |  | 6,122 |
Proceeds from the issuance of shares in connection with at-the-market offering, net of issuance costs | — |  |  | 19,153 |
Net cash (used in) provided by financing activities | $ | (13,419) |  |  | $ | 4,024 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | $ | 13,606 |  |  | $ | (7,138) |
Net decrease in cash, cash equivalents, and restricted cash at the end of the period | (22,859) |  |  | (13,257) |
Cash, cash equivalents, and restricted cash at the beginning of period | 216,716 |  |  | 250,077 |
Cash, cash equivalents, and restricted cash at the end of period | $ | 193,857 |  |  | $ | 236,820 |
Supplemental disclosures of cash flow information |  |  |
Cash paid during the period for interest | $ | 32,852 |  |  | $ | 47,587 |
Cash paid for taxes | $ | 2,345 |  |  | $ | 2,729 |
Supplemental disclosure of non-cash investing and financing activities |  |  |
Tenant improvements paid through lease incentives | $ | 292 |  |  | $ | 217 |
Capital expenditures unpaid at the end of period | $ | — |  |  | $ | 168 |
Cashless exercise of warrants | $ | 71 |  |  | $ | — |

See accompanying Notes to Consolidated Financial Statements
8

Amicus Therapeutics, Inc.
Notes to the Consolidated Financial Statements
(Unaudited)
1. Description of Business
Amicus Therapeutics, Inc. (the "Company") is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. The Company seeks to deliver the highest quality therapies that have the potential to obsolete current treatments, provide significant benefits to patients, and be first- or best-in-class. The Company's two marketed therapies are Galafold®, the first oral monotherapy for people living with Fabry disease who have amenable genetic variants, and Pombiliti® + Opfolda®, a novel two-component treatment for adults living with late-onset Pompe disease.
Galafold® (also referred to as "migalastat"), is approved in over 40 countries around the world, including the United States ("U.S."), European Union ("E.U."), United Kingdom ("U.K."), and Japan. Additionally, Galafold® has been granted orphan drug designation in the U.S., E.U., U.K., Japan and several other countries.
Pombiliti® + Opfolda® (also referred to as "cipaglucosidase alfa-atga/miglustat"), is approved in the U.S., the E.U., the U.K., Canada, Australia, Switzerland, and Japan. Multiple regulatory submissions and reimbursement processes with global health authorities are currently underway. Additionally, Pombiliti® + Opfolda® has been granted orphan drug designation or status in the U.S., U.K., Switzerland, and Japan and data exclusivity in the E.U.
On April 30, 2025, the Company entered into an exclusive license agreement with Dimerix Bioscience Pty Limited ("Dimerix") for the commercialization of Dimerix' Phase 3 drug candidate, DMX-200, in the United States for treatment of Focal Segmental Glomerulosclerosis ("FSGS") and other indications. Refer to "— Note 6. Licensing Agreement," in our Notes to Consolidated Financial Statements.
The Company had an accumulated deficit of $2.8 billion as of September 30, 2025 and anticipates incurring losses through the fiscal year ending December 31, 2025. The Company has historically funded its operations through stock offerings, product revenues, debt issuances, collaborations, and other financing arrangements.
Based on its current operating model, which includes expected revenues, the Company believes the current cash position is sufficient to fund the Company's operations and ongoing research programs for at least the next 12 months. Potential business development opportunities, pipeline expansion, and investment in manufacturing capabilities could impact the Company's long-term capital requirements.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with the U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, certain financial information that is normally included in annual financial statements prepared in accordance with U.S. GAAP, but that is not required for interim reporting purposes, has been omitted. In the opinion of management, the accompanying unaudited Consolidated Financial Statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's interim financial information. Management has determined that the Company operates in one segment focused on discovering, developing, and delivering novel medicines for rare diseases.
The accompanying unaudited Consolidated Financial Statements and related notes should be read in conjunction with the Company's financial statements and related notes as contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024. For a complete description of the Company's accounting policies, please refer to the Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Consolidation
The Consolidated Financial Statements include the accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation.
9

Foreign Currency Transactions
The functional currency for most of the Company's foreign subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the weighted average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of stockholders' equity. Transactions which are not in the functional currency of the entity are remeasured into the functional currency with gains or losses resulting from the remeasurement recorded in other income (expense).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash
The Company considers all highly liquid investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents. Marketable securities consist of fixed income investments with a maturity of greater than three months and other highly liquid investments that can be readily purchased or sold using established markets. These investments are classified as available-for-sale and are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are reported within other comprehensive (loss) income in the Company's Consolidated Statements of Comprehensive Income (Loss). Fair value is based on available market information including quoted market prices, broker or dealer quotations, or other observable inputs. The cost of securities sold is based on the specific identification method.
Restricted cash consists primarily of funds held to satisfy the requirements of certain agreements that are restricted in their use and is included as a component of other non-current assets on the Company's Consolidated Balance Sheets.
Concentration of Credit Risk
The Company's financial instruments that are exposed to concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities.
The Company maintains its cash and cash equivalents in bank accounts, which, at times, exceed federally insured limits. The Company invests its marketable securities in high-quality commercial financial instruments. The Company has not recognized any losses from credit risks on such accounts during any of the periods presented. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents, or marketable securities.
The Company is subject to credit risk from its accounts receivable primarily related to its product sales of Galafold® and Pombiliti® + Opfolda®. The Company's accounts receivable at September 30, 2025 have arisen from product sales primarily in Europe, the U.S., and Japan. The Company periodically assesses the financial strength of its customers to establish allowances for anticipated losses, if any. The Company's allowance for doubtful accounts was $2.7 million and $3.0 million as of September 30, 2025 and December 31, 2024, respectively.
Revenue Recognition
The Company has recorded revenue on sales where its products are available either on a commercial basis or through a reimbursed early access program. Product orders are generally received from distributors and pharmacies.
The Company recognizes revenue when its performance obligations to its customers have been satisfied, which occurs at a point in time when the pharmacies or distributors obtain control of the products. The transaction price is determined based on fixed consideration in the Company's customer contracts and is recorded net of estimates for variable consideration, which primarily consist of third-party discounts and rebates. The identified variable consideration is recorded as a reduction of revenue at the time revenue from the sale is recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.
10

The following table summarizes the Company's net product sales disaggregated by product and geographic area:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(in thousands) |  | 2025 |  | 2024 |  | 2025 |  | 2024
Galafold® U.S. |  | $ | 57,198 |  |  | $ | 47,333 |  |  | $ | 150,964 |  |  | $ | 124,218 |
Galafold® Ex-U.S. |  | 81,149 |  |  | 73,048 |  |  | 220,499 |  |  | 206,339 |
Total Galafold® sales |  | $ | 138,347 |  |  | $ | 120,381 |  |  | $ | 371,463 |  |  | $ | 330,557 |
Pombiliti® + Opfolda® U.S. |  | $ | 13,070 |  |  | 8,859 |  |  | 33,627 |  |  | 19,487 |
Pombiliti® + Opfolda® Ex-U.S. |  | 17,644 |  |  | 12,277 |  |  | 43,908 |  |  | 28,545 |
Total Pombiliti® + Opfolda® sales |  | $ | 30,714 |  |  | $ | 21,136 |  |  | $ | 77,535 |  |  | $ | 48,032 |
Total net product sales |  | $ | 169,061 |  |  | $ | 141,517 |  |  | $ | 448,998 |  |  | $ | 378,589 |

Inventories and Cost of Goods Sold
Until regulatory approval of Pombiliti® + Opfolda®, the Company expensed all manufacturing costs as research and development expense. Upon regulatory approval, the Company began capitalizing costs related to the purchase and manufacture of Pombiliti® + Opfolda®.
Inventories are stated at the lower of cost and net realizable value, determined by the first-in, first-out method. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on projected sales activity as well as product shelf-life. In evaluating the recoverability of inventories produced, the probability that revenue will be obtained from the future sale of the related inventory is considered and inventory value is written down for inventory quantities in excess of expected requirements. Expired inventory is disposed of and the related costs are recognized as cost of goods sold in the Company's Consolidated Statements of Operations.
Cost of goods sold includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, provisions for excess and obsolete inventory, as well as royalties payable. A portion of inventory available for sale was expensed as research and development costs prior to regulatory approval and as such, the cost of goods sold and related gross margins are not necessarily indicative of future costs of goods sold and gross margin.
Income Taxes
The Company’s tax returns are subject to examination by U.S. Federal, state, and foreign taxing jurisdictions. The impact of an uncertain tax position taken or expected to be taken on an income tax return must be recognized in the financial statements at the largest amount that is more likely than not to be sustained. An uncertain income tax position will not be recognized in the financial statements unless it is more likely than not to be sustained.
The ending amount of unrecognized tax benefits was $20.0 million and $13.8 million as of September 30, 2025, and December 31, 2024, respectively. For the three and nine months ended September 30, 2025, approximately $5.8 million and $6.2 million of unrecognized tax benefits would, if recognized, impact the Company’s effective tax rate, respectively, compared to $1.1 million and $6.1 million in the same periods for the prior year.
Earnings (loss) per common share
The Company calculates earnings (loss) per share as a measurement of the Company's performance while giving effect to all dilutive potential common shares that were outstanding during the reporting period. Basic earnings (loss) per share is computed based on net income (loss) attributable to common stockholders divided by the weighted average number of common shares outstanding during the period. Diluted earnings (loss) per share is computed consistently with the basic computation plus the effect of dilutive potential common shares outstanding during the period. Dilutive potential common shares include shares that the Company could be obligated to issue from its outstanding stock-based compensation awards. In periods in which a net loss is presented, the inclusion of common stock options and unvested restricted stock units would be anti-dilutive. For purposes of computing diluted earnings (loss) per share, weighted average common shares do not include potentially dilutive shares if their effect is anti-dilutive. As such, the shares the Company could be obligated to issue from its stock options are excluded from the earnings (loss) per share calculation if the exercise price exceeds the average market price of common shares. The Company uses the treasury stock method to calculate the dilutive effect of outstanding stock-based compensation.
11

Segment Information
The Company currently operates in one business segment focused on discovering, developing, and delivering novel medicines for rare diseases. The Company is not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision maker ("CODM"), its Chief Executive Officer, who comprehensively manages the entire business. The Company and its CODM evaluate performance and allocate resources primarily based on Net product sales and Net income (loss) within the Consolidated Statement of Operations that is regularly provided. Net income (loss) is used to monitor budget to actual results and actuals against prior periods. The Company does not accumulate discrete financial information with respect to separate service lines, and thus there is one reportable segment. The Company does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Consolidated Statements of Operations and Consolidated Balance Sheets provide information regarding significant segment expenses and segment assets. Revenue segregation by product line and geographic area is presented in the revenue recognition section earlier in this footnote.
Recent Accounting Developments - Guidance Adopted in 2025
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, must be applied prospectively with an option to apply retrospectively, and early adoption is permitted. The Company adopted this guidance on January 1, 2025. This ASU applies to disclosure requirements only, and the Company will provide required annual disclosures as part of the 2025 Annual Report on Form 10-K. The adoption of this guidance is not expected to have a significant impact on the Company's Consolidated Financial Statements.
Recent Accounting Developments - Guidance Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, "Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses." The standard is intended to require more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is currently assessing the impact this standard will have on its Consolidated Financial Statements.
In July 2025, the FASB issued ASU 2025-05, "Financial Instruments - Credit Losses (Topic 326)". The standard is intended to simplify the calculation of current expected credit losses by allowing companies to elect a practical expedient to assume that current market conditions as of the balance sheet date will not change over the life of the asset. This ASU is effective for fiscal years beginning after December 15, 2025. Early adoption is permitted. The Company is currently assessing the impact this standard will have on its Consolidated Financial Statements.
In September 2025, the FASB issued ASU 2025-06, "Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) related to accounting for internal-use software costs. The amendments in this update improve the operability of the guidance by removing all references to software development project stages so that the guidance is neutral to different software development methods. This update is effective for annual periods beginning after December 15, 2027, including interim periods within those fiscal years, though early adoption is permitted. The Company is currently assessing the impact this standard will have on its Consolidated Financial Statements.
12

3. Cash, Cash Equivalents, Marketable Securities, and Restricted Cash
As of September 30, 2025, the Company held $190.6 million in cash and cash equivalents and $73.3 million of marketable securities which are reported at fair value on the Company's Consolidated Balance Sheets. Unrealized holding gains and losses are generally reported within other comprehensive loss (income) in the Consolidated Statements of Comprehensive Income (Loss). If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other-than-temporary or if an available-for-sale debt security’s fair value is determined to be less than the amortized cost and the Company intends or is more than likely to sell the security before recovery and it is not considered a credit loss, such security is written down to its estimated fair value as a new cost basis and the amount of the write-down is included in the Consolidated Statements of Operations as an impairment charge. If the unrealized loss of an available-for-sale debt security is determined to be a result of credit loss, the Company would recognize an allowance and the corresponding credit loss would be included in the Consolidated Statements of Operations.
The Company regularly invests excess operating cash in deposits with major financial institutions, money market funds, notes issued by the U.S. government, as well as fixed income investments and U.S. bond funds, both of which can be readily purchased and sold using established markets. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated as, in accordance with Company policy, such securities are of high credit rating. Investments that have original maturities greater than three months but less than one year are classified as current. All marketable securities represent the investment of funds available for current operations, notwithstanding their contractual maturities.
Cash, cash equivalents and marketable securities are classified as current unless mentioned otherwise below and consisted of the following:

|  | As of September 30, 2025
(in thousands) |  | Cost |  | Gross Unrealized Gain |  | Gross Unrealized Loss |  | Fair Value
Cash and cash equivalents |  | $ | 190,553 |  |  | $ | — |  |  | $ | — |  |  | $ | 190,553 |
U.S. government agency bonds |  | 42,123 |  |  | 126 |  |  | (9) |  |  | 42,240 |
Commercial paper |  | 18,385 |  |  | 5 |  |  | — |  |  | 18,390 |
Corporate debt securities |  | 12,484 |  |  | 24 |  |  | (1) |  |  | 12,507 |
Money market |  | 100 |  |  | — |  |  | — |  |  | 100 |
Certificates of deposit |  | 53 |  |  | — |  |  | — |  |  | 53 |
|  | $ | 263,698 |  |  | $ | 155 |  |  | $ | (10) |  |  | $ | 263,843 |
Included in cash and cash equivalents |  | $ | 190,553 |  |  | $ | — |  |  | $ | — |  |  | $ | 190,553 |
Included in marketable securities |  | 73,145 |  |  | 155 |  |  | (10) |  |  | 73,290 |
Total cash, cash equivalents, and marketable securities |  | $ | 263,698 |  |  | $ | 155 |  |  | $ | (10) |  |  | $ | 263,843 |

|  | As of December 31, 2024
(in thousands) |  | Cost |  | Gross Unrealized Gain |  | Gross Unrealized Loss |  | Fair Value
Cash and cash equivalents |  | $ | 213,752 |  |  | $ | — |  |  | $ | — |  |  | $ | 213,752 |
Commercial paper |  | 18,082 |  |  | 3 |  |  | (4) |  |  | 18,081 |
U.S. government agency bonds |  | 16,524 |  |  | 1 |  |  | (7) |  |  | 16,518 |
Corporate debt securities |  | 1,446 |  |  | — |  |  | (2) |  |  | 1,444 |
Money market |  | 100 |  |  | — |  |  | — |  |  | 100 |
Certificate of deposit |  | 51 |  |  | — |  |  | — |  |  | 51 |
|  | $ | 249,955 |  |  | $ | 4 |  |  | $ | (13) |  |  | $ | 249,946 |
Included in cash and cash equivalents |  | $ | 213,752 |  |  | $ | — |  |  | $ | — |  |  | $ | 213,752 |
Included in marketable securities |  | 36,203 |  |  | 4 |  |  | (13) |  |  | 36,194
Total cash, cash equivalents, and marketable securities |  | $ | 249,955 |  |  | $ | 4 |  |  | $ | (13) |  |  | $ | 249,946 |

13

For both the nine months ended September 30, 2025 and September 30, 2024, there were no realized gains or losses.
Unrealized loss positions in the marketable securities as of September 30, 2025 reflect temporary impairments and are not a result of credit loss. Additionally, as these positions have been in a loss position for less than twelve months and the Company does not intend to sell these securities before recovery, the losses are recognized as a component of other comprehensive income (loss). The fair value of these marketable securities in unrealized loss positions are $8.7 million and $23.7 million as of September 30, 2025 and December 31, 2024, respectively.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheets that sum to the total shown in the Consolidated Statements of Cash Flows.

|  | As of September 30,
(in thousands) |  | 2025 |  | 2024
Cash and cash equivalents |  | $ | 190,553 |  |  | $ | 233,647 |
Restricted cash |  | 3,304 |  |  | 3,173 |
Cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows |  | $ | 193,857 |  |  | $ | 236,820 |

4. Inventories
The following table summarizes the components of the Company’s inventories for each of the periods indicated:

(in thousands) |  | September 30, 2025 |  | December 31, 2024
Raw materials |  | $ | 105,295 |  |  | $ | 87,916 |
Work-in-process |  | 39,263 |  |  | 21,223 |
Finished goods |  | 33,370 |  |  | 9,643 |
Total inventories |  | $ | 177,928 |  |  | $ | 118,782 |

The Company's reserve for inventory was $2.2 million and $3.3 million as of September 30, 2025 and December 31, 2024, respectively.
5. Debt
The following table summarizes the Company's debt for each of the periods indicated:

(in thousands) |  | September 30, 2025 |  | December 31, 2024
Senior Secured Term Loan due 2029: |  |  |  |
Principal |  | $ | 400,000 |  |  | $ | 400,000 |
Less: debt discount (1) |  | (6,355) |  |  | (7,863) |
Less: deferred financing (1) |  | (1,660) |  |  | (2,026) |
Net carrying value of long-term debt |  | $ | 391,985 |  |  | $ | 390,111 |

______________________________
(1) Included in the Company's Consolidated Balance Sheets within long-term debt and amortized to interest expense over the remaining life of the Senior Secured Term Loan due 2029 using the effective interest rate method.
14

Interest Expense
The following table sets forth interest expense recognized related to the Company's debt for each of the periods indicated:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30, |  |
(in thousands) |  | 2025 |  | 2024 |  | 2025 |  | 2024 |  |  |  |
Contractual interest expense |  | $ | 11,044 |  |  | $ | 12,106 |  |  | $ | 32,815 |  |  | $ | 36,021 |  |  |  |  |
Amortization of debt discount |  | $ | 523 |  |  | $ | 455 |  |  | $ | 1,507 |  |  | $ | 1,313 |  |  |  |  |
Amortization of deferred financing |  | $ | 134 |  |  | $ | 119 |  |  | $ | 387 |  |  | $ | 352 |  |  |  |  |

6. Licensing Agreement
Dimerix Limited
On April 30, 2025, the Company entered into an exclusive license agreement with Dimerix Limited ("Dimerix") for the commercialization of Dimerix' Phase 3 drug candidate, DMX-200, in the United States for treatment of Focal Segmental Glomerulosclerosis ("FSGS") and other indications. In exchange for these rights, the Company paid Dimerix an upfront payment of $30 million, which was recorded as a component of research and development expense in the Company's Consolidated Statement of Operations. The Company will be obligated to pay Dimerix for certain success-based development and regulatory milestones for FSGS of up to a maximum aggregate amount of $75 million, regulatory milestones for other indications of up to a maximum aggregate amount of $40 million, commercial milestones of up to a maximum aggregate amount of $445 million, and tiered royalties of DMX-200 net sales in the U.S. ranging from the low-teens to low-twenties.
Dimerix will continue to fund and execute the Phase 3 study of DMX-200 ("ACTION3"), and Amicus will be responsible for submission and maintenance of the regulatory dossier in the United States, as well as all costs of commercialization activities. Additionally, Amicus will have the exclusive rights to develop DMX-200 in other future indications in the United States. Amicus and Dimerix have formed a Joint Steering Committee to align the development and commercialization of DMX-200 in FSGS in U.S. The agreement otherwise contains terms common for an arrangement of this kind.
7. Stock-Based Compensation
The Company's stockholders approved the 2025 Equity Incentive Plan (the "2025 Equity Plan") at the 2025 Annual Meeting of Stockholders, held on June 5, 2025 (the “Annual Meeting”), to replace the expiring Amended and Restated 2007 Equity Incentive Plan (the "2007 Equity Plan"). Following approval of the 2025 Equity Plan, no future awards are permitted to be granted under the 2007 Equity Plan. The maximum number of shares of our common stock that may be issued under the 2025 Equity Plan (subject to certain adjustments) is the sum of (i) 9.0 million shares which were approved by stockholders at the Annual Meeting; plus (ii) the number of shares reserved for issuance under the 2007 Equity Plan that remained available for grant under the 2007 Equity Plan as of the Annual Meeting; plus (iii) any shares underlying 2007 Equity Plan awards that may become available for issuance under the 2025 Equity Plan in accordance with the 2025 Equity Plan provisions.
Stock Option Grants
The fair value of the stock options granted were estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30, |  |
|  | 2025 |  | 2024 |  | 2025 |  | 2024 |  |  |  |
Expected stock price volatility |  | 55.1 | % |  | 55.5 | % |  | 55.5 | % |  | 57.1 | % |  |  |  |
Risk free interest rate |  | 3.8 | % |  | 3.9 | % |  | 4.2 | % |  | 4.0 | % |  |  |  |
Expected life of options (years) |  | 5.6 |  | 5.6 |  | 5.6 |  | 5.6 |  |  |  |
Expected annual dividend per share |  | $ | — |  |  | $ | — |  |  | $ | — |  |  | $ | — |  |  |  |  |

A summary of the Company's stock options for the nine months ended September 30, 2025 were as follows:
15

|  | Number of Shares |  | Weighted Average Exercise Price |  | Weighted Average Remaining Years |  | Aggregate Intrinsic Value
|  | (in thousands) |  |  |  |  |  | (in millions)
Options outstanding, December 31, 2024 |  | 26,013 |  |  | $ | 12.11 |  |  |  |  |
Granted |  | 4,012 |  |  | $ | 8.45 |  |  |  |  |
Exercised |  | (79) |  |  | $ | 6.06 |  |  |  |  |
Forfeited |  | (477) |  |  | $ | 11.33 |  |  |  |  |
Expired |  | (1,127) |  |  | $ | 13.10 |  |  |  |  |
Options outstanding, September 30, 2025 |  | 28,342 |  |  | $ | 11.58 |  |  | 5.6 |  | $ | 4.3 |
Vested and non-vested expected to vest, September 30, 2025 |  | 27,274 |  |  | $ | 11.60 |  |  | 5.5 |  | $ | 4.2 |
Exercisable at September 30, 2025 |  | 20,138 |  |  | $ | 11.93 |  |  | 4.5 |  | $ | 2.6 |

As of September 30, 2025, the total unrecognized compensation cost related to non-vested stock options granted was $35.4 million and is expected to be recognized over a weighted average period of two years.
Restricted Stock Units and Performance-Based Restricted Stock Units (collectively "RSUs")
RSUs awarded are generally subject to graded vesting and are contingent on an employee's continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. A summary of non-vested RSU activity for the nine months ended September 30, 2025 is as follows:

|  | Number of Shares |  | Weighted Average Grant Date Fair Value |  | Weighted Average Remaining Years |  | Aggregate Intrinsic Value
|  | (in thousands) |  |  |  |  |  | (in millions)
Non-vested units as of December 31, 2024 |  | 8,277 |  |  | $ | 13.59 |  |  |  |  |
Granted |  | 7,608 |  |  | $ | 8.75 |  |  |  |  |
Vested |  | (2,786) |  |  | $ | 11.10 |  |  |  |  |
Forfeited |  | (948) |  |  | $ | 10.68 |  |  |  |  |
Non-vested units as of September 30, 2025 |  | 12,151 |  |  | $ | 11.01 |  |  | 2.4 |  | $ | 95.8 |

As of September 30, 2025, there was $74.3 million of total unrecognized compensation cost related to non-vested RSUs with service-based vesting conditions. These costs are expected to be recognized over a weighted average period of two years.
Compensation Expense Related to Equity Awards
The following table summarizes information related to compensation expense recognized in the Company's Consolidated Statements of Operations related to the equity awards:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(in thousands) |  | 2025 |  | 2024 |  | 2025 |  | 2024
Research and development expense |  | $ | 2,368 |  |  | $ | 4,397 |  |  | $ | 8,765 |  |  | $ | 12,329 |
Selling, general, and administrative expense |  | 15,721 |  |  | 14,291 |  |  | 52,055 |  |  | 53,359 |
Total equity compensation expense |  | $ | 18,089 |  |  | $ | 18,688 |  |  | $ | 60,820 |  |  | $ | 65,688 |

16

8. Assets and Liabilities Measured at Fair Value
The Company's financial assets and liabilities are measured at fair value and classified within the fair value hierarchy, which is defined as follows:
Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly.
Level 3 — Inputs that are unobservable for the asset or liability.
A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of September 30, 2025 are identified in the following tables:

(in thousands) |  | Level 1 |  | Level 2 |  | Total
Assets: |  |  |  |  |  |
U.S. government agency bonds |  | $ | — |  |  | $ | 42,240 |  |  | $ | 42,240 |
Commercial paper |  | — |  |  | 18,390 |  |  | 18,390 |
Corporate debt securities |  | — |  |  | 12,507 |  |  | 12,507 |
Money market |  | 2,180 |  |  | — |  |  | 2,180 |
|  | $ | 2,180 |  |  | $ | 73,137 |  |  | $ | 75,317 |

(in thousands) |  | Level 1 |  | Level 2 |  | Total
Liabilities: |  |  |  |  |  |
Deferred compensation plan liability |  | $ | 2,080 |  |  | $ | — |  |  | $ | 2,080 |
|  | $ | 2,080 |  |  | $ | — |  |  | $ | 2,080 |

A summary of the fair value of the Company's recurring assets and liabilities aggregated by the level in the fair value hierarchy within which those measurements fall as of December 31, 2024 are identified in the following tables:

(in thousands) |  | Level 1 |  | Level 2 |  | Total
Assets: |  |  |  |  |  |
Commercial paper |  | $ | — |  |  | $ | 18,081 |  |  | $ | 18,081 |
U.S. government agency bonds |  | — |  |  | 16,518 |  |  | 16,518 |
Corporate debt securities |  | — |  |  | 1,444 |  |  | 1,444 |
Money market |  | 2,318 |  |  | — |  |  | 2,318 |
|  | $ | 2,318 |  |  | $ | 36,043 |  |  | $ | 38,361 |

(in thousands) |  | Level 1 |  | Level 2 |  | Total
Liabilities: |  |  |  |  |  |
Deferred compensation plan liability |  | 2,218 |  |  | — |  |  | 2,218 |
|  | $ | 2,218 |  |  | $ | — |  |  | $ | 2,218 |

17

Deferred compensation plan liability is recorded as a component of other non-current liabilities on the Company's Consolidated Balance Sheets. The Company did not have any Level 3 assets or liabilities as of September 30, 2025 or December 31, 2024.
Cash, Money Market Funds, and Marketable Securities
The Company classifies its cash and money market funds within the fair value hierarchy as Level 1 as these assets are valued using quoted prices in an active market for identical assets at the measurement date. The Company considers its investments in marketable securities as available-for-sale and classifies these assets within the fair value hierarchy as Level 2 primarily utilizing broker quotes in a non-active market for valuation of these securities.
9. Basic and Diluted Net Earnings (Loss) per Common Share
The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted earnings per share:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(in thousands, except per share amounts) |  | 2025 |  | 2024 |  | 2025 |  | 2024
Numerator: |  |  |  |  |  |  |  |
Net income (loss) attributable to common stockholders |  | $ | 17,306 |  |  | $ | (6,729) |  |  | $ | (28,800) |  |  | $ | (70,845) |
Denominator: |  |  |  |  |  |  |  |
Weighted average common shares outstanding — basic |  | 308,468,423 |  |  | 304,690,596 |  |  | 308,139,134 |  |  | 303,792,479 |
Dilutive effect of stock based compensation awards (a) |  | 1,965,071 |  |  | — |  |  | — |  |  | — |
Weighted average common shares outstanding — diluted |  | 310,433,494 |  |  | 304,690,596 |  |  | 308,139,134 |  |  | 303,792,479 |
Earnings (loss) per share attributable to common shareholders: |  |  |  |  |  |  |  |
Basic earnings (loss) per share |  | 0.06 |  |  | (0.02) |  |  | (0.09) |  |  | (0.23) |
Diluted earnings (loss) per share |  | 0.06 |  |  | (0.02) |  |  | (0.09) |  |  | (0.23) |

______________________________
(a) The Company was in a net loss position for the nine months ended September 30, 2025 and both the three and nine months ended September 30, 2024 and therefore the impact of stock-based compensation awards was excluded from the computation of dilutive loss per share as the inclusion of such amounts would be anti-dilutive.
The table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method. Because the Company had a net loss for both comparative periods, the weighted average shares used to calculate both basic and diluted earnings per share are the same:

|  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(in thousands) |  | 2025 |  | 2024 |  | 2025 |  | 2024
Options to purchase common stock |  | 27,026 |  |  | 26,139 |  |  | 28,342 |  |  | 26,139 |
Non-vested restricted stock units |  | 8,601 |  |  | 9,453 |  |  | 12,151 |  |  | 9,453 |
Total number of potentially issuable shares |  | 35,627 |  |  | 35,592 |  |  | 40,493 |  |  | 35,592 |

18

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the unaudited Consolidated Financial Statements and the notes thereto included in this Quarterly Report on Form 10-Q and the audited Consolidated Financial Statements and the notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Some of the statements we make in this section are forward-looking statements within the meaning of the federal securities laws. For a complete discussion of forward-looking statements, see the section in this Quarterly Report on Form 10-Q entitled “Special Note Regarding Forward-Looking Statements”. Certain risk factors may cause actual results, performance or achievements to differ materially from those expressed or implied by the following discussion. For a discussion of such risk factors, see the section in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 entitled “Risk Factors”.
Overview
We are a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. We seek to deliver the highest quality therapies that have the potential to obsolete current treatments, provide significant benefits to patients, and be first- or best-in-class. Our two marketed therapies are Galafold®, the first oral monotherapy for people living with Fabry disease who have amenable genetic variants, and Pombiliti® + Opfolda®, a novel two-component treatment for adults living with late-onset Pompe disease.
Galafold® (also referred to as "migalastat") is approved in over 40 countries around the world, including the United States ("U.S."), European Union ("E.U."), United Kingdom ("U.K."), and Japan. Additionally, Galafold® has been granted orphan drug designation in the U.S., E.U., U.K., Japan and several other countries.
Pombiliti® + Opfolda® (also referred to as "cipaglucosidase alfa-atga/miglustat") is approved in the U.S., the E.U., the U.K., Canada, Australia, Switzerland, and Japan. Multiple regulatory submissions and reimbursement processes with global health authorities are currently underway. Additionally, Pombiliti® + Opfolda® has been granted orphan drug designation or status in the U.S., U.K., Switzerland, and Japan and data exclusivity in the E.U.
On April 30, 2025, we entered into an exclusive license agreement with Dimerix Bioscience Pty Limited ("Dimerix") for the United States commercialization rights of Dimerix' Phase 3 drug candidate, DMX-200 for treatment of Focal Segmental Glomerulosclerosis ("FSGS") and other indications. In exchange for these rights, we paid Dimerix an upfront payment of $30 million. We will be obligated to pay Dimerix for certain success-based development and regulatory milestones for FSGS of up to a maximum aggregate amount of $75 million, regulatory milestones for other indications of up to a maximum aggregate amount of $40 million, commercial milestones of up to a maximum aggregate amount of $445 million, and tiered royalties of DMX-200 net sales in the U.S. ranging from the low-teens to low-twenties. Dimerix will continue to fund and execute the ACTION3 study, and we will be responsible for submission and maintenance of the regulatory dossier in the United States, as well as all costs of commercialization activities. Additionally, we will have the exclusive rights to develop DMX-200 in other future indications in the United States. Amicus and Dimerix have formed a Joint Steering Committee to align the development and commercialization of DMX-200 in FSGS in U.S.
Our Strategy
Our strategy is to create, manufacture, test, and deliver the highest quality medicines for people living with rare diseases through internally developed, jointly developed, acquired, or in-licensed products and product candidates. We are leveraging our global capabilities to develop and broaden our franchises in Fabry and Pompe disease, with focused discovery work on next generation therapies and novel technologies.
Highlights of our progress include:
•Commercial success in Fabry disease. For the nine months ended September 30, 2025, Galafold® revenue was $371.5 million of consolidated revenue, which represented an increase of $40.9 million compared to the same period in the prior year. We continue to see strong commercial momentum and expansion into additional geographies.
•Commercial and regulatory success in Pompe disease. For the nine months ended September 30, 2025, Pombiliti® + Opfolda® revenue was $77.5 million of consolidated revenue. As of September 30, 2025, Pombiliti® + Opfolda® has been approved by the respective regulatory authorities in the E.U., U.S., U.K., Canada, Switzerland, Australia, and Japan. Additionally, throughout 2024 and 2025, we established reimbursement agreements in multiple E.U. countries.
19

•Pipeline advancement and growth. On April 30, 2025, Amicus licensed exclusive rights to commercialize DMX-200, a small molecule currently in a pivotal Phase 3 study ("ACTION3"), in the United States for treatment of FSGS and other indications.
•Financial strength. Total cash, cash equivalents, and marketable securities as of September 30, 2025 was $263.8 million.
Our Commercial Products and Product Candidates
Galafold® (migalastat HCl) for Fabry Disease
Our oral precision medicine, Galafold®, was granted accelerated approval by the FDA in August 2018 for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ("GLA") variant based on in vitro assay data. Galafold® was approved in the E.U. and U.K. in May 2016 as a first-line therapy for long-term treatment of adults and adolescents, aged 16 years and older, with a confirmed diagnosis of Fabry disease and who have an amenable variant. Marketing authorization approvals as well as approvals for adolescents aged 12 years and older weighing 45 kg or more have been granted in over 40 countries around the world. We plan to continue to launch Galafold® in additional countries upon receipt of marketing authorization.
As an orally administered monotherapy, Galafold® is designed to bind to and stabilize an endogenous alpha-galactosidase A ("alpha-Gal A") enzyme in those patients with genetic variants identified as amenable in a Good Laboratory Practice ("GLP") cell-based amenability assay.
Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease
We have leveraged our biologics capabilities to develop Pombiliti® + Opfolda®, a novel two-component treatment paradigm for Pompe disease. Pombiliti® + Opfolda® was approved by the European Commission ("EC"), the Medicines and Healthcare products Regulatory Agency ("MHRA"), and the FDA in 2023, the Swissmedic and the Therapeutics Good Administration in Australia in 2024, and Health Canada, and Japan's Ministry of Health, Labor and Welfare in 2025 for adult late-onset Pompe disease ("LOPD") patients. Additional regulatory submissions and reimbursement processes with global health authorities are currently underway.
Pombiliti® + Opfolda® consists of a uniquely engineered recombinant human acid alpha-glucosidase ("rhGAA") enzyme, cipaglucosidase alfa-atga, with an optimized carbohydrate structure to enhance cellular uptake, administered intravenously in combination with orally administered miglustat. Miglustat binds to and stabilizes the cipaglucosidase alfa-atga in circulation reducing inactivation of rhGAA in circulation to improve the uptake of active enzyme into key disease relevant tissues. Miglustat is not an active ingredient that contributes directly to glycogen reduction.
In addition, clinical studies are ongoing in pediatric patients for both the LOPD and infantile-onset Pompe disease ("IOPD") populations.
DMX-200 for Focal Segmental Glomerulosclerosis (FSGS)
DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2) under development in a pivotal Phase 3 study (ACTION3), for the treatment of FSGS kidney disease. In early 2024, Dimerix reported positive interim results from the ACTION3 trial in FSGS showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date. An additional blinded interim analysis is planned once the revised primary and secondary endpoints have been pre-specified in the protocol and agreed with the FDA. In a March 2025 Type C meeting, Dimerix successfully aligned with the FDA on proteinuria as an appropriate primary endpoint for traditional marketing approval for DMX-200.
FSGS is a rare, serious kidney disorder characterized by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to leakage of protein into the urine (proteinuria), and progressive loss of kidney function leading to end-stage kidney disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and children. There are no therapies specifically approved for FSGS in the U.S. Management of the disease relies on non-specific immunosuppressive and supportive therapies. In patients with progressive or treatment-resistant FSGS, the average time from diagnosis to end-stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases, underscoring the urgent need for new, disease-modifying treatments. DMX-200 is the only clinical-stage kidney disease program that
20

specifically targets monocyte-driven inflammation, a mechanistic approach distinct from all other known therapies in development. Several other agents are in late-stage clinical development for FSGS, targeting alternative pathways including endothelin receptor antagonists and APOL1 inhibitors. Preclinical in vitro data supports potential mechanistic synergy between DMX-200 and endothelin antagonists.
Next Generation Therapies
We are committed to continued innovation for all people living with Fabry or Pompe disease. As part of our long-term commitment, we are also continuing discovery for next-generation genetic medicines for Fabry and Pompe disease.
Strategic Alliances and Arrangements
We will continue to evaluate business development opportunities to build stockholder value and provide us with access to the financial, technical, clinical, commercial resources, and intellectual property necessary to develop and market technologies or products in rare and orphan diseases. We are exploring potential collaborations, alliances, and various other business development opportunities on a regular basis. These opportunities may include business combinations, partnerships, the strategic in-licensing or out-licensing of certain assets, or the acquisition of preclinical-stage, clinical-stage, or marketed products or novel technologies consistent with our corporate strategy to develop and provide therapies to patients living with rare and orphan diseases.
Consolidated Results of Operations
Three Months Ended September 30, 2025 compared to September 30, 2024
The following table provides selected financial information for the Company:

|  | Three Months Ended September 30,
(in thousands) |  | 2025 |  | 2024 |  | Change
Net product sales |  | $ | 169,061 |  |  | $ | 141,517 |  |  | $ | 27,544 |
Cost of goods sold |  | 19,467 |  |  | 13,279 |  |  | 6,188 |
Gross profit |  | 149,594 |  |  | 128,238 |  |  | 21,356 |
Operating expenses: |  |  |  |  |  |
Research and development |  | 23,415 |  |  | 26,160 |  |  | (2,745) |
Selling, general, and administrative |  | 90,036 |  |  | 75,106 |  |  | 14,930 |
Restructuring charges |  | — |  |  | 3,143 |  |  | (3,143) |
Depreciation and amortization |  | 1,874 |  |  | 2,170 |  |  | (296) |
Other expense: |  |  |  |  |  |
Interest income |  | 829 |  |  | 1,081 |  |  | (252) |
Interest expense |  | (11,711) |  |  | (12,692) |  |  | 981 |
Other income (expense) |  | 10,887 |  |  | (3,263) |  |  | 14,150 |
Income tax expense |  | (16,968) |  |  | (13,514) |  |  | (3,454) |
Net income (loss) attributable to common stockholders |  | $ | 17,306 |  |  | $ | (6,729) |  |  | $ | 24,035 |

Net Product Sales. Net product sales increased $27.5 million during the three months ended September 30, 2025 compared to the same period in the prior year. The increase was due to the continued growth of Galafold® and Pombiliti® + Opfolda® in Europe and the U.S. and a $3.8 million favorable impact of foreign currency exchange.
21

Cost of Goods Sold. Cost of goods sold includes manufacturing costs as well as royalties associated with net product sales. Cost of goods sold increased by $6.2 million primarily related to the increase in net product sales. A portion of Pombiliti® inventory was expensed as research and development costs prior to regulatory approval and as such, the cost of goods sold and related gross margins are not necessarily indicative of future costs of goods sold and gross margin.
Research and Development Expense. The following table summarizes our principal development programs and the expenses incurred:

(in thousands) |  | Three Months Ended September 30,
Projects |  | 2025 |  | 2024
Third party direct project expenses |  |  |  |
Galafold® (Fabry disease) |  | $ | 2,771 |  |  | $ | 2,380 |
Pombiliti® + Opfolda® (Pompe disease) |  | 10,145 |  |  | 10,590 |
Pre-clinical and other programs |  | 413 |  |  | 646 |
Total third-party direct project expenses |  | 13,329 |  |  | 13,616 |
Other project costs |  |  |  |
Personnel costs |  | 7,467 |  |  | 9,707 |
Other costs |  | 2,619 |  |  | 2,837 |
Total other project costs |  | 10,086 |  |  | 12,544 |
Total research and development costs |  | $ | 23,415 |  |  | $ | 26,160 |

The $2.7 million decrease in research and development costs was primarily driven by lower personnel costs.
Selling, General, and Administrative Expense. Selling, general, and administrative expense increased $14.9 million, primarily driven by higher professional fees to support ongoing legal efforts and increased personnel costs resulting from an increase in headcount to support the supply of our products.
Other Income (Expense). The net change of $14.2 million was primarily related to movement in foreign exchange rates caused by remeasurement of foreign-denominated balances.
Income Tax Expense. We are subject to income taxes in various jurisdictions. Our tax liabilities are largely dependent on the mix of pre-tax earnings among the many jurisdictions in which we operate and differences in the timing of the recognition of such earnings under the relevant accounting standards and tax rules.
22

Nine Months Ended September 30, 2025 compared to September 30, 2024
The following table provides selected financial information for the Company:

|  | Nine Months Ended September 30, 2025
(in thousands) |  | 2025 |  | 2024 |  | Change
Net product sales |  | $ | 448,998 |  |  | $ | 378,589 |  |  | $ | 70,409 |
Cost of goods sold |  | 46,382 |  |  | 38,107 |  |  | 8,275 |
Gross profit |  | 402,616 |  |  | 340,482 |  |  | 62,134 |
Operating expenses: |  |  |  |  |  |
Research and development |  | 112,102 |  |  | 79,172 |  |  | 32,930 |
Selling, general, and administrative |  | 266,406 |  |  | 236,711 |  |  | 29,695 |
Restructuring charges |  | — |  |  | 9,188 |  |  | (9,188) |
Loss on impairment of assets |  | 1,702 |  |  | — |  |  | 1,702 |
Depreciation and amortization |  | 5,563 |  |  | 6,506 |  |  | (943) |
Other expense: |  |  |  |  |  |
Interest income |  | 2,484 |  |  | 3,991 |  |  | (1,507) |
Interest expense |  | (34,731) |  |  | (37,640) |  |  | 2,909 |
Other income (expense) |  | 12,452 |  |  | (11,946) |  |  | 24,398 |
Income tax expense |  | (25,848) |  |  | (34,155) |  |  | 8,307 |
Net loss attributable to common stockholders |  | $ | (28,800) |  |  | $ | (70,845) |  |  | $ | 42,045 |

Net Product Sales. Net product sales increased $70.4 million during the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was due to the continued growth of Galafold® and Pombiliti® + Opfolda® in Europe and the U.S. and a $7.7 million favorable impact of foreign currency exchange.
Cost of Goods Sold. Cost of goods sold includes manufacturing costs as well as royalties associated with net product sales. Cost of goods sold increased by $8.3 million primarily related to the increase in net product sales. A portion of Pombiliti® inventory was expensed as research and development costs prior to regulatory approval and as such, the cost of goods sold and related gross margins are not necessarily indicative of future costs of goods sold and gross margin.
Research and Development Expense. The following table summarizes our principal development programs and expenses incurred:

(in thousands) |  | Nine Months Ended September 30, 2025
Projects |  | 2025 |  | 2024
Third party direct project expenses |  |  |  |
Galafold® (Fabry disease) |  | $ | 9,912 |  |  | $ | 6,420 |
Pombiliti® + Opfolda® (Pompe disease) |  | 38,629 |  |  | 31,003 |
DMX-200 (FSGS kidney disease) |  | 30,000 |  |  | — |
Pre-clinical and other programs |  | 1,238 |  |  | 2,095 |
Total third-party direct project expenses |  | 79,779 |  |  | 39,518 |
Other project costs |  |  |  |
Personnel costs |  | 24,639 |  |  | 31,287 |
Other costs |  | 7,684 |  |  | 8,367 |
Total other project costs |  | 32,323 |  |  | 39,654 |
Total research and development costs |  | $ | 112,102 |  |  | $ | 79,172 |

The $32.9 million increase in research and development costs was primarily driven by the $30.0 million upfront license payment to Dimerix.
23

Selling, General, and Administrative Expense. Selling, general, and administrative expense increased $29.7 million, primarily driven by $13.6 million of higher personnel costs resulting from an increase in headcount to support the supply of our products, $7.2 million of higher professional fees to support ongoing legal efforts, and $5.7 million of higher expense in connection with our continuing expansion of manufacturing capabilities.
Restructuring Charges. In the first quarter of 2024, restructuring charges were primarily related to an initiative to reduce operating costs by abandoning a lease that was no longer useful in our operations.
Other Income (Expense). The net change of $24.4 million was primarily related to movement in foreign exchange rates caused by remeasurement of foreign-denominated balances.
Income Tax Expense. We are subject to income taxes in various jurisdictions. Our tax liabilities are largely dependent on the mix of pre-tax earnings among the many jurisdictions in which we operate and differences in the timing of the recognition of such earnings under the relevant accounting standards and tax rules.
Liquidity and Capital Resources
As a result of our significant research and development expenditures, as well as expenditures to build a commercial organization to support the launch of Galafold® and Pombiliti® + Opfolda®, we have not been profitable and have generated operating losses since we were incorporated in 2002. We have historically funded our operations through stock offerings, product revenues, debt issuance, collaborations, and other financing arrangements.
Sources of Liquidity
In November 2022, we entered into a Sales Agreement with Goldman Sachs & Co. LLC to create an at-the-market equity program ("ATM program"), pursuant to which we may offer to sell shares of our common stock having an aggregate offering gross proceeds of up to $250.0 million. As of September 30, 2025, an aggregate of $164.2 million worth of shares remain available to be issued and sold under the ATM program.
Cash Flow Discussion
As of September 30, 2025, we had cash, cash equivalents, and marketable securities of $263.8 million. We invest cash in excess of our immediate requirements in regard to liquidity and capital preservation in a variety of interest-bearing instruments, including obligations of U.S. government agencies and money market accounts. Wherever possible, we seek to minimize the potential effects of concentration and degrees of risk. Although we maintain cash balances with financial institutions in excess of insured limits, we do not anticipate any losses with respect to such cash balances. For more details on the cash, cash equivalents, and marketable securities, refer to "— Note 3. Cash, Cash Equivalents, Marketable Securities, and Restricted Cash," in our Notes to Consolidated Financial Statements.
Net Cash Provided by (Used in) Operating Activities
Net cash provided by operations for the nine months ended September 30, 2025 was $16.9 million. The components of net cash provided by operations primarily reflect net loss of $28.8 million adjusted for non-cash expenses of $78.6 million, which includes $60.8 million of stock compensation and $5.6 million of depreciation expense. This is further driven by a net increase in operating assets and liabilities of $32.9 million. The changes in operating assets and liabilities were primarily driven by an increase in inventory of $67.2 million to support our continued commercial growth and an increase in other non-current assets and liabilities of $4.3 million, partially offset by a $44.6 million increase in accounts payable and accrued expenses.
Net cash used in operations for the nine months ended September 30, 2024 was $30.0 million. The components of net cash used in operations included the net loss for the nine months ended September 30, 2024 of $70.8 million and a net decrease in changes in operating assets and liabilities of $55.2 million, offset by $65.7 million of stock compensation and $30.4 million of other non-cash adjustments. The changes in operating assets and liabilities were primarily due to an increase in inventory of $61.6 million to support our continued commercial growth and an increase in accounts receivable of $9.1 million, partially offset by a decrease in prepaid expenses and other current assets of $28.2 million and a decrease in accounts payable and accrued expenses of $11.5 million associated with timing of payments.
24

Net Cash Used in (Provided by) Investing Activities
Net cash used in investing activities for the nine months ended September 30, 2025 was $39.9 million. Our investing activities have consisted primarily of purchases, sales, and maturities of investments and capital expenditures. Net cash used in investing activities reflects $71.4 million for the purchase of marketable securities, partially offset by $34.4 million from the sale and redemption of marketable securities and $3.0 million for capital expenditures.
Net cash provided by investing activities for the nine months ended September 30, 2024 was $19.8 million. Our investing activities have consisted primarily of purchases, sales and maturities of investments and capital expenditures. Net cash provided by investing activities reflects $101.9 million from the sale and redemption of marketable securities, partially offset by $78.8 million for the purchase of marketable securities and $3.3 million for capital expenditures.
Net Cash Used in (Provided by) Financing Activities
Net cash used in financing activities for the nine months ended September 30, 2025 was $13.4 million. Net cash used in financing activities primarily reflects withholding taxes paid on vested restricted stock units of $13.9 million.
Net cash provided by financing activities for the nine months ended September 30, 2024 was $4.0 million. Net cash provided by financing activities primarily reflects $19.2 million of proceeds from the issuance of shares in connection with the ATM program offering, net of issuance costs, and $6.1 million of proceeds from the exercise of stock options, partially offset by the withholding taxes paid on vested restricted stock units of $21.2 million.
Funding Requirements
We expect to continue incurring significant costs in the foreseeable future primarily due to research and development expenses, including expenses related to conducting clinical trials. Our future capital requirements will depend on a number of factors, including:
•the scope, progress, results and costs of clinical trials for our drug candidates;
•the cost of manufacturing drug supply for our commercial, clinical and preclinical studies, including the cost of manufacturing Pombiliti® (also referred to as "ATB200" or "cipaglucosidase alfa");
•the future results of preclinical research and subsequent clinical trials for pipeline candidates we may identify from time to time, including our ability to obtain regulatory approvals and commercialize such therapies;
•the costs, timing, and outcome of regulatory review of our product candidates;
•any changes in regulatory standards relating to the review of our product candidates;
•any changes in laws, rules or regulations, including the imposition of tariffs or other trade restrictions, affecting our ability to manufacture, transport, test, develop, or commercialize our products, including Galafold®, Pombiliti® + Opfolda®, or our product candidates;
•the costs of commercialization activities, including product marketing, sales, and distribution;
•the emergence of competing technologies and other adverse market developments;
•the estimates regarding the potential market opportunity for our products and product candidates;
•our ability to successfully commercialize Galafold® (also referred to as "migalastat HCl");
•our ability to successfully commercialize Pombiliti® + Opfolda® in the E.U., U.K., Japan, and U.S., and elsewhere, if regulatory applications are approved;
•our ability to manufacture or supply sufficient clinical or commercial products, including Galafold® and Pombiliti® + Opfolda®;
•our ability to obtain reimbursement for Galafold® and Pombiliti® + Opfolda®;
•our ability to satisfy post-marketing commitments or requirements for continued regulatory approval of Galafold® and Pombiliti® + Opfolda®;
25

•our ability to obtain market acceptance of Galafold® and Pombiliti® + Opfolda® or any other product developed or acquired that has received regulatory approval;
•the costs of preparing, filing, and prosecuting patent applications and maintaining, enforcing, and defending intellectual property-related claims, including Hatch-Waxman litigation;
•the impact of litigation that has been or may be brought against us or of litigation that we are pursuing or may pursue against others, including Hatch-Waxman litigation;
•the extent to which we acquire or invest in businesses, products, and technologies;
•our ability to successfully integrate acquired products and technologies into our business, or successfully divest or license existing products and technologies from our business, including the possibility that the expected benefits of the transactions will not be fully realized by us or may take longer to realize than expected;
•our ability to establish licensing agreements, collaborations, partnerships or other similar arrangements and to obtain milestone, royalty, or other economic benefits from any such collaborators;
•the costs associated with, and our ability to comply with, emerging sustainability standards, including climate reporting requirements at the local, state and national levels, especially abroad;
•our ability to successfully protect our information technology systems and maintain our global operations and supply chain without interruption;
•our ability to accurately forecast revenue, operating expenditures, or other metrics impacting profitability;
•fluctuations in foreign currency exchange rates; and
•changes in accounting standards.
We may seek additional funding through public or private financings of debt or equity. Based on our current operating model, which includes expected revenues, we believe that the current cash position is sufficient to fund our operations and ongoing research programs for at least the next 12 months. Potential impacts of business development collaborations, pipeline expansion, and investment in manufacturing capabilities could impact our long-term capital requirements.
Critical Accounting Policies and Significant Judgments
The discussion and analysis of our financial condition and results of operations are based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments and make changes when necessary. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There were no significant changes during the nine months ended September 30, 2025 to the items that we disclosed as our significant accounting policies and estimates described in "—Note 2. Summary of Significant Accounting Policies" to the Company's financial statements as contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Recent Accounting Pronouncements
Please refer to "—Note 2. Summary of Significant Accounting Policies" in our Notes to Consolidated Financial Statements.
26

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our market risks, and the way we manage them, are summarized in Part II, Item 7A, "Quantitative and Qualitative Disclosures About Market Risk" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. As of September 30, 2025, there have been no material changes to our market risks or to our management of such risks since December 31, 2024.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, an evaluation of the effectiveness of our disclosure controls and procedures (pursuant to Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act") was carried out under the supervision of our Principal Executive Officer and Principal Financial Officer, with the participation of our management. Based on that evaluation, the Principal Executive Officer and the Principal Financial Officer concluded that, as of the end of such period, our disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the Exchange Act and are effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
During the fiscal quarter covered by this report, there has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In the fourth quarter of 2022, the Company received Paragraph IV Certification Notice Letters from Teva Pharmaceuticals USA, Inc. ("Teva"), Aurobindo Pharma Limited ("Aurobindo"), and Lupin Limited ("Lupin") in connection with Abbreviated New Drug Applications (“ANDA”) filed with the FDA requesting approval to market generic Galafold®. In November 2022, the Company filed four lawsuits against Teva, Lupin, and Aurobindo in the U.S. District Court for the District of Delaware (the "District Court") for infringement of its Orange Book-listed patents. In the fourth quarter of 2023, a stipulation order to stay litigation with respect to Lupin was ordered. Additionally, in the first quarter of 2024, a stipulation was filed with the court and approved by the presiding judge, whereby the parties agreed to accept the Company’s definition of the terms that were in dispute. As such, the scheduled Markman hearing was deemed unneeded and cancelled.
In October 2024, the Company entered into a non-exclusive, non-transferable, royalty-free, fully paid-up license with Teva which will allow Teva to market its generic version of Galafold® in the United States beginning on January 30, 2037, or earlier in certain circumstances. In accordance with the license agreement, a consent judgment and permanent injunction was entered with the District Court and all Hatch-Waxman litigation between Amicus and Teva has been terminated. As required by law, Amicus and Teva have submitted the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
From September 29, 2025 to October 1, 2025, the District Court held a three-day trial to hear evidence and argument as to the disputed patent issues between Aurobindo and the Company. Following the conclusion of the trial, the Company and Aurobindo will submit a post-trial briefing that is scheduled to conclude by December 16, 2025. The Company anticipates that the District Court will render its decision after considering the post-trial briefing. Once the District Court has issued its substantive decision, the Company will update the market by filing a Form 8-K within four business days.
The litigation stay continues to remain in place for Lupin. The Company has, and will continue to, vigorously enforce its Galafold® intellectual property rights.
ITEM 1A. RISK FACTORS
There have been no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
27

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
The following table provides certain information with respect to purchase of our common stock during the three months ended September 30, 2025:

Period |  | Total Number of Shares Purchased (1) |  | Average Price Paid per Share |  | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs |  | Maximum Number (or Approximate Dollar Value) of Shares That May Yet Be Purchased Under the Plans or Programs
July 1, 2025 through July 31, 2025 |  | 136,435 |  |  | $ | 5.98 |  |  | — |  |  | — |
August 1, 2025 through August 31, 2025 |  | 111,563 |  |  | $ | 7.21 |  |  | — |  |  | — |
September 1, 2025 through September 30, 2025 |  | 12,991 |  |  | $ | 7.73 |  |  | — |  |  | — |
Total |  | 260,989 |  |  | $ | 6.59 |  |  | — |  |  | — |

______________________________
(1) Represents shares of common stock withheld to satisfy taxes associated with the vesting of restricted stock units
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
None.
28

ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Plans
The following table describes, for the quarterly period covered by this report, each director and officer (as defined in Rule 16a-1(f) under the Exchange Act) who has adopted, modified, or terminated a trading plan intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act (each plan, a "Rule 10b5-1 Trading Plan"). Each Rule 10b5-1 Trading Plan described below was adopted during an open insider trading window and in accordance with the Company's policies regarding both insider trading and transactions relating to Company securities.

Name (Title) |  | Action Taken (Date of Action) |  | Rule 10b5-1 Trading Plan Provides for Purchase/Sale |  | Duration of the Trading Plan(1) |  | Aggregate Number of Securities
Bradley Campbell (President & Chief Executive Officer) |  | Adoption (September 12, 2025) (2) |  | Sale |  | December 31, 2026 |  | Indeterminable(3)
David Clark (Chief People Officer) |  | Adoption (September 10, 2025) (4) |  | Sale |  | August 15, 2026 |  | Indeterminable(5)
Ellen Rosenberg (Chief Legal Officer) |  | Adoption (August 27, 2025)(6) |  | Sale |  | January 3, 2027 |  | Indeterminable(7)
Jeffrey Castelli (Chief Development Officer) |  | Adoption (August 22, 2025) |  | Sale |  | January 31, 2026 |  | 76,158(8)

____________________________
(1) The dates in this column represent the scheduled expiration date of each officer’s Rule 10b5-1 Trading Plan. Each Rule 10b5-1 Trading Plan may terminate earlier than the date provided should all transactions contemplated thereunder occur prior to such date.
(2) Trading under Mr. Campbell’s new Rule 10b5-1 Trading Plan may not commence until January 19, 2026, which is after the expiration date of Mr. Campbell’s existing Rule 10b5-1 Trading Plan, adopted on September 13, 2024 (the “Existing Campbell Plan”), and disclosed in the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2024.
(3) Mr. Campbell’s new Rule 10b5-1 Trading Plan provides for the (i) sale of 90,000 shares of common stock which have been obtained from the vesting of restricted stock unit (“RSU”) and performance restricted stock unit (“PRSU”) awards; and (ii) exercise, and subsequent sale of underlying common stock, of an indeterminable number of stock options. The total number of stock options exercised, and sale of underlying shares of common stock, is dependent on the number of stock options exercised, and sale of underlying shares of common stock, that are ultimately sold under the Exiting Campbell Plan.
(4) Trading under Mr. Clark’s new Rule 10b5-1 Trading Plan may not commence until January 2, 2026, which is after the expiration date of Mr. Clark’s existing Rule 10b5-1 Trading Plan, adopted on March 14, 2025 (the “Existing Clark Plan”), and disclosed in the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2025.
(5) Mr. Clark’s new Rule 10b5-1 Trading Plan provides for the sale of an indeterminable number of shares of common stock which have been obtained from the vesting of RSU and PRSU awards. The total number of shares of common stock available for sale is dependent on the number of shares that are ultimately sold under the Exiting Clark Plan.
(6) Trading under Ms. Rosenberg’s new Rule 10b5-1 Trading Plan may not commence until January 2, 2026, which is after the expiration date of Ms. Rosenberg’s existing Rule 10b5-1 Trading Plan, adopted on September 10, 2024 (the “Existing Rosenberg Plan”), and disclosed in the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2024.
(7) Ms. Rosenberg’s new Rule 10b5-1 Trading Plan provides for the exercise, and subsequent sale of underlying common stock, of an indeterminable number of stock options. The total number of stock options exercised, and sale of underlying shares of common stock, is dependent on the number of stock options exercised, and sale of underlying shares of common stock, that are ultimately sold under the Exiting Rosenberg Plan.
(8) Mr. Castelli’s Rule 10b5-1 Trading Plan provides for (i) the exercise of up to 50,000 stock options and the sale of up to 50,000 underlying shares of common stock; and (ii) the sale of 26,158 shares of common stock which have been obtained from the vesting of RSU and PRSU awards.
29

ITEM 6. EXHIBITS

Exhibit Number |  | Description |
*10.1 |  | Second Amendment to the Supply and Manufacturing Services Agreement dated March 31, 2023 by and among the Company, WuXi Biologics (Hong Kong) Limited, WuXi Biologics Ireland Limited and WuXi Biologics Germany GmbH (filed herewith) |
*10.2 |  | Third Amendment to the Supply and Manufacturing Services Agreement dated March 31, 2023 by and among the Company, WuXi Biologics (Hong Kong) Limited, WuXi Biologics Ireland Limited and WuXi Biologics Germany GmbH (filed herewith) |
31.1 |  | Certification of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant to the Securities Exchange Act of 1934, as amended |
31.2 |  | Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant to the Securities Exchange Act of 1934, as amended |
32.1 |  | Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
101.INS |  | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
101.SCH |  | Inline XBRL Taxonomy Extension Schema Document |
101.CAL |  | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.LAB |  | Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |  | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
101.DEF |  | Inline XBRL Taxonomy Extension Definition Linkbase Document |
104 |  | Cover Page Interactive Data File (formatted in Inline XBRL and included in Exhibit 101) |

* Portions of the exhibit have been omitted in accordance with CFR § 229.601(b)(10)(iv).
____________________________________________________________________
30

SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

|  | AMICUS THERAPEUTICS, INC.
Date: | November 4, 2025 | By: | /s/ Bradley L. Campbell
|  |  | Bradley L. Campbell
|  |  | President and Chief Executive Officer
|  |  | (Principal Executive Officer)
Date: | November 4, 2025 | By: | /s/ Simon Harford
|  |  | Simon Harford
|  |  | Chief Financial Officer
|  |  | (Principal Financial Officer)

31