Galafold Performance and Outlook - Galafold achieved revenue of $329 million in 2022, with a 16% operational growth at Constant Exchange Rates (CER)[17, 37] - Q4 2022 Galafold revenue reached $88 million[14] - The company anticipates Galafold revenue growth of 12-17% at CER in 2023[3, 9, 25] - Galafold has treated over 2,000 individuals globally[18, 20] AT-GAA Development and Regulatory Status - AT-GAA is under global regulatory review for Pompe disease[3] - Regulatory approvals for AT-GAA in the three largest Pompe markets are anticipated in 2023[31] - The European Commission (EC) decision for Pombiliti™ (cipaglucosidase alfa) is expected in Q1 2023, with a CHMP opinion for Miglustat expected in Q2 2023 and an EC decision in Q3 2023[31] - FDA approval for AT-GAA is anticipated in Q3 2023[31] Financial Goals and Profitability - The company is focused on prudent expense management and aims to achieve non-GAAP profitability in the second half of 2023[3, 25, 39] - 2023 non-GAAP operating expense guidance is set at $340 million to $360 million[25] - Cash as of December 31, 2022, was $294 million[3] AT-GAA Clinical Data - Approximately 200 people living with Pompe disease are currently receiving AT-GAA through extension studies and expanded access programs[23]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 Jurisdicti ...

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, 2022 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 J ...

Galafold Performance and Outlook - Galafold achieved $80.7 million in revenue for 2Q22[10], contributing to $1594 million in 1H22 revenue, representing a 109% reported growth[11] and 178% operational growth at CER[11] - The company is reiterating FY22 Galafold revenue guidance of $350 million to $365 million at CER, indicating a 15% to 20% growth at CER[4, 8, 10, 12] - The company anticipates near-term growth to $500 million, driven by continued penetration into existing markets, expansion into new geographies, and broadening of labels[13] AT-GAA Development and Launch - AT-GAA is under global regulatory reviews, with a U S PDUFA date in 2H2022 and a CHMP opinion expected late 2022[4, 20, 21] - Over 175 people living with Pompe disease are currently receiving AT-GAA through clinical extension studies and expanded access programs[20] - Phase 3 PROPEL study results showed greater improvement with AT-GAA vs alglucosidase alfa in ERT-naïve and ERT-experienced patients[18] Financial Position and Strategy - The company reported $386.8 million in cash as of June 30, 2022[4] - The company is focused on prudent expense management to achieve profitability in 2023[4, 5, 39] - 2Q22 operating expenses increased, reflecting manufacturing costs for AT-GAA launch and non-recurring expenses related to gene therapy portfolio reprioritization[37] - The company's 2022 non-GAAP operating expense guidance is $470 million to $485 million[39]

PART I. FINANCIAL INFORMATION [Consolidated Financial Statements and Notes (unaudited)](index=6&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20and%20Notes%20(unaudited)) The company's Q2 2022 financial statements reflect increased revenue but a wider net loss, driven by higher operating expenses and a non-recurring charge [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2022, total assets decreased to **$800.6 million**, liabilities increased to **$627.2 million**, and stockholders' equity declined to **$173.4 million** Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $235,639 | $245,197 | | Total current assets | $497,643 | $596,834 | | Total Assets | $800,589 | $905,140 | | **Liabilities & Equity** | | | | Total current liabilities | $164,625 | $145,975 | | Long-term debt | $390,652 | $389,357 | | Total liabilities | $627,164 | $597,771 | | Total stockholders' equity | $173,425 | $307,369 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) Q2 2022 net product sales increased to **$80.7 million**, but net loss widened to **$62.2 million** due to higher R&D and SG&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $80,731 | $77,413 | $159,446 | $143,815 | | Gross profit | $72,534 | $69,033 | $143,667 | $128,896 | | Research and development | $78,319 | $63,003 | $159,836 | $127,120 | | Selling, general, and administrative | $53,379 | $42,276 | $111,495 | $89,002 | | Loss from operations | $(60,613) | $(38,834) | $(135,952) | $(91,889) | | Net loss | $(62,157) | $(51,225) | $(147,417) | $(116,889) | | Net loss per share | $(0.21) | $(0.19) | $(0.51) | $(0.44) | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$74.2 million** in H1 2022, with overall cash decreasing by **$9.6 million** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(74,177) | $(108,277) | | Net cash provided by investing activities | $84,505 | $112,278 | | Net cash (used in) provided by financing activities | $(7,461) | $11,064 | | **Net (decrease) increase in cash** | **$(9,595)** | **$13,626** | [Notes to Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail business focus, accounting policies, AT-GAA regulatory status, a **$20.0 million** non-recurring charge, **$6.6 million** asset impairment, **$400 million** term loan, and **$19.3 million** contingent consideration - The company's lead pipeline biologic, AT-GAA for Pompe disease, is under review by the FDA and EMA. The FDA extended the PDUFA action dates to August 29, 2022 (for miglustat) and October 29, 2022 (for cipaglucosidase alfa)[38](index=38&type=chunk) - In Q2 2022, due to a strategic prioritization of its gene therapy portfolio, the company recorded a non-recurring **$20.0 million** liability for contractual obligations and recognized a **$6.6 million** impairment charge on fixed assets[60](index=60&type=chunk)[54](index=54&type=chunk) - The company's debt consists of a **$400 million** Senior Secured Term Loan due 2026, with a net carrying value of **$390.7 million** as of June 30, 2022[69](index=69&type=chunk) - Contingent consideration payable for the ATB200 Pompe disease program (from the Callidus acquisition) was valued at **$19.3 million** as of June 30, 2022, classified as a Level 3 liability[80](index=80&type=chunk)[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Galafold's success, AT-GAA's progress, and H1 2022 financial results showing revenue growth offset by wider losses due to increased expenses and one-time charges - The company's strategy is to develop first- or best-in-class medicines for rare diseases, leveraging its global capabilities to broaden its lead franchises in Fabry and Pompe disease[89](index=89&type=chunk) - Total cash, cash equivalents, and marketable securities were **$386.8 million** as of June 30, 2022. The company believes this position is sufficient to fund operations to achieve self-sustainability[92](index=92&type=chunk)[112](index=112&type=chunk) - The company faces significant future potential milestone payments related to its acquisitions and collaborations, including up to **$88 million** remaining for the Callidus acquisition (Pompe program) and up to **$88 million** per indication for its collaboration with the University of Pennsylvania[120](index=120&type=chunk)[123](index=123&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Net product sales increased year-over-year, but operating expenses rose significantly due to non-recurring charges and higher personnel costs, leading to wider net losses Comparison of Three Months Ended June 30, 2022 and 2021 (in thousands) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $80,731 | $77,413 | $3,318 | | Research and development | $78,319 | $63,003 | $15,316 | | Selling, general, and administrative | $53,379 | $42,276 | $11,103 | | Net loss | $(62,157) | $(51,225) | $(10,932) | - The **$15.3 million** increase in Q2 2022 R&D costs was primarily driven by a non-recurring expense from a contractual obligation related to the strategic prioritization of the gene therapy portfolio[103](index=103&type=chunk) Comparison of Six Months Ended June 30, 2022 and 2021 (in thousands) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $159,446 | $143,815 | $15,631 | | Research and development | $159,836 | $127,120 | $32,716 | | Selling, general, and administrative | $111,495 | $89,002 | $22,493 | | Loss on impairment of assets | $6,616 | $— | $6,616 | | Net loss | $(147,417) | $(116,889) | $(30,528) | - For H1 2022, net product sales growth of **$15.6 million** was partially offset by an unfavorable foreign currency impact of **$9.9 million**[106](index=106&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q2 2022 with **$386.8 million** in cash and marketable securities, believing it sufficient to fund operations to self-sustainability - As of June 30, 2022, the company had cash, cash equivalents, and marketable securities of **$386.8 million**[112](index=112&type=chunk) - Net cash used in operating activities for H1 2022 was **$74.2 million**, an improvement from **$108.3 million** in H1 2021. The change was primarily due to non-cash adjustments and timing of payments for R&D and other expenses[113](index=113&type=chunk) - The company has significant potential future milestone and royalty payment obligations to partners including Callidus, Celenex, Nationwide Children's Hospital, University of Pennsylvania, and GSK[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No material changes to the company's market risks or their management have occurred since December 31, 2021 - As of June 30, 2022, there have been no material changes to the company's market risks since the fiscal year ended December 31, 2021[129](index=129&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes in internal control over financial reporting - An evaluation concluded that the company's disclosure controls and procedures are effective as of the end of the period covered by the report[130](index=130&type=chunk) - No change in internal control over financial reporting occurred during the last fiscal quarter that has materially affected, or is reasonably likely to materially affect, internal controls[131](index=131&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[132](index=132&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the Annual Report on Form 10-K for FY2021 - No material changes have been made to the risk factors disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[133](index=133&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities, but withheld **40,812** shares at **$8.15** per share for tax obligations - There were no recent sales of unregistered securities[134](index=134&type=chunk) Issuer Purchases of Equity Securities (Q2 2022) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2022 | 6,588 | $8.31 | | May 2022 | 23,164 | $7.64 | | June 2022 | 11,060 | $9.13 | | **Total** | **40,812** | **$8.15** | [Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[136](index=136&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) The report lists various exhibits filed with the SEC, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include CEO and CFO certifications pursuant to Rules 13a-14 and 15d-14, and Section 906 of the Sarbanes-Oxley Act[139](index=139&type=chunk)

PART I. [FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited consolidated financial statements, including balance sheets, statements of operations, cash flows, and related notes, along with management's discussion and analysis [Item 1. Consolidated Financial Statements and Notes (unaudited)](index=5&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20and%20Notes%20(unaudited)) This section presents Amicus Therapeutics, Inc.'s unaudited consolidated financial statements, detailing financial position, operational results, and cash flows for the period ended March 31, 2022 [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2022, the company reported total assets of $826.9 million, a decrease from $905.1 million at year-end 2021, primarily due to a reduction in cash, cash equivalents, and marketable securities Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $233,317 | $245,197 | | Investments in marketable securities | $177,878 | $237,299 | | Total current assets | $518,900 | $596,834 | | Total Assets | $826,938 | $905,140 | | **Liabilities & Equity** | | | | Total current liabilities | $129,699 | $145,975 | | Long-term debt | $389,994 | $389,357 | | Total liabilities | $588,321 | $597,771 | | Total stockholders' equity | $238,617 | $307,369 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2022, net product sales grew to $78.7 million from $66.4 million in the prior-year period, while net loss widened to $85.3 million due to increased expenses and an impairment charge Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net product sales | $78,715 | $66,402 | | Gross profit | $71,133 | $59,863 | | Research and development | $81,517 | $64,117 | | Selling, general, and administrative | $58,116 | $46,726 | | Loss from operations | ($75,339) | ($53,055) | | Net loss | ($85,260) | ($65,664) | | Net loss per share — basic and diluted | ($0.30) | ($0.25) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the first quarter of 2022, net cash used in operating activities was $58.3 million, offset by $58.2 million provided by investing activities, resulting in a net decrease in cash of $11.6 million Consolidated Cash Flow Summary (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($58,315) | ($72,354) | | Net cash provided by investing activities | $58,213 | $86,565 | | Net cash (used in) provided by financing activities | ($8,154) | $8,829 | | Net (decrease) increase in cash | ($11,633) | $21,887 | | Cash at end of period | $237,823 | $188,049 | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section details the company's business, accounting policies, and financial statement components, including product pipeline updates and cash sufficiency outlook - The company's lead product is **Galafold®** for **Fabry disease**, and its lead pipeline candidate is **AT-GAA** for **Pompe disease**, which is under review by the **FDA** and **EMA**[29](index=29&type=chunk)[30](index=30&type=chunk) - The **FDA** extended the **PDUFA action dates** for **AT-GAA** components to **August 29, 2022**, and **October 29, 2022**[30](index=30&type=chunk) - The company believes its current cash position, including expected revenues, is **sufficient to fund operations to achieve self-sustainability**[31](index=31&type=chunk) - An **impairment charge** of **$6.6 million** was recognized in **Q1 2022** due to the strategic prioritization of its gene therapy portfolio[46](index=46&type=chunk) Net Product Sales of Galafold® by Geographic Area (in thousands) | Region | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | U.S. | $24,178 | $20,858 | | Ex-U.S. | $54,537 | $45,544 | | **Total** | **$78,715** | **$66,402** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operational results for Q1 2022, focusing on revenue growth, increased net loss, and liquidity position - **Galafold® revenue** for **Q1 2022** was **$78.7 million**, an **increase of $12.3 million (19%)** compared to **Q1 2021**, driven by growth in the U.S., Europe, and Japan[82](index=82&type=chunk)[94](index=94&type=chunk) - The company's lead pipeline biologic, **AT-GAA** for **Pompe disease**, is under review by the **FDA** and **EMA**, with **revised PDUFA dates** in **August and October 2022**[80](index=80&type=chunk) Comparison of Operating Results (in thousands) | Line Item | Q1 2022 | Q1 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $78,715 | $66,402 | $12,313 | | Research and development | $81,517 | $64,117 | $17,400 | | Selling, general, and administrative | $58,116 | $46,726 | $11,390 | | Loss on impairment of assets | $6,616 | $— | $6,616 | | Net loss | ($85,260) | ($65,664) | ($19,596) | - The **increase in R&D costs** was primarily due to **manufacturing costs for the Pompe program**, **contract exit costs for gene therapy programs**, and **higher personnel costs**[95](index=95&type=chunk) - Total cash, cash equivalents, and marketable securities as of **March 31, 2022**, was **$411.2 million**[85](index=85&type=chunk)[99](index=99&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that as of March 31, 2022, there have been no material changes to its market risks or the management of such risks since the disclosures made in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 - There have been **no material changes** to the company's market risks since **December 31, 2021**[116](index=116&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of the company's disclosure controls and procedures, concluding they were effective with no material changes in internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of the end of the period[117](index=117&type=chunk) - **No material changes** were made to the company's internal control over financial reporting during the quarter[118](index=118&type=chunk) PART II. [OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional disclosures, including legal proceedings, risk factors, equity security sales, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is **not currently involved in any material legal proceedings**[119](index=119&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors that were previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 - There have been **no material changes** to the risk factors disclosed in the company's **2021 Form 10-K**[120](index=120&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period and detailed issuer purchases of equity securities for tax obligations related to vested restricted stock units - There were **no sales of unregistered securities** in the quarter[121](index=121&type=chunk) - The company repurchased **797,911 shares** of common stock at an average price of **$11.38 per share** to satisfy taxes related to vested restricted stock units[122](index=122&type=chunk) [Item 3. Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[123](index=123&type=chunk) [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - None[124](index=124&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[125](index=125&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a termination agreement, an employment agreement, officer certifications, and interactive data files (XBRL) - Exhibits filed include a **termination agreement**, an **employment agreement** for John F. Crowley, and **certifications** by the Principal Executive Officer and Principal Financial Officer[127](index=127&type=chunk) [Signatures](index=31&type=section&id=SIGNATURES) This section contains the required signatures, affirming the accuracy and completeness of the filed report

| --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2 Forward-Looking Statements This presentation contains"forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinic ...

Financial Data and Key Metrics Changes - For the full year 2021, Galafold revenue was $306 million, reflecting a 17% increase over 2020, with operational revenue growth at constant currency rates of 14% and a positive currency impact of 3% [7][42] - The net loss for 2021 was $250.5 million or $0.92 per share, compared to a net loss of $276.9 million or $1.07 per share for the prior year [42] - Cash, cash equivalents, and marketable securities were $482.5 million at December 31, 2021, compared to $483.3 million at the end of 2020 [46] Business Line Data and Key Metrics Changes - Galafold's total product revenue was $306 million globally, with $210 million (69%) generated outside the U.S. and $95 million (31%) from within the U.S. [23][24] - The company ended 2021 with over 1,750 patients on Galafold globally, achieving nearly half of the global market share of treated amenable patients [28] - Compliance and adherence rates for Galafold exceeded 90%, indicating strong patient retention [30] Market Data and Key Metrics Changes - In Europe, the company achieved an 80% to 90% market share of switch patients, while in the U.S. and Japan, the market remains approximately 50/50 between switch and naïve patients [29] - New markets in Latin America and Asia Pacific are showing greater traction, contributing to growth expectations for the coming years [29] Company Strategy and Development Direction - The company has decided not to spin off its gene therapy programs due to unfavorable market conditions and will focus on core franchises in Fabry and Pompe diseases [11][12] - Strategic investments will be made in the global growth of Galafold and the launch of AT-GAA, with a target of achieving profitability in 2023 [10][12] - The company anticipates approximately $400 million in net cost savings through 2026 by streamlining its R&D operations [13][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory approval of AT-GAA, with a PDUFA action date set for May 29, 2022, and July 29, 2022, for the NDA and BLA, respectively [8][36] - The company remains committed to maintaining a strong financial position and achieving profitability without the need for dilutive financing [10][45] - Management highlighted the importance of patient access to Galafold and the anticipated demand for AT-GAA, indicating a positive outlook for future growth [30][40] Other Important Information - The company is preparing for the global launch of AT-GAA, leveraging its existing commercial organization that has experience in rare disease markets [32][40] - The leadership transition is set for August 1, 2022, with Bradley Campbell succeeding John Crowley as CEO [20] Q&A Session Summary Question: Inquiry about mid-cycle review and inspections - Management indicated a positive mid-cycle review with no surprises and confirmed that inspections of the WuXi facility are planned [49][50] Question: Inventory position and supply chain management - The company confirmed a strong inventory position to support launches in the U.S. and Europe, with effective supply chain management in place [51][53] Question: Trends in patient initiation for Galafold - Management noted that patient initiation trends are improving, with a return to normalcy in interactions between patients and physicians [56][58] Question: Uptake expectations for AT-GAA compared to Neo-GAA - Management expressed confidence in the uptake of AT-GAA, particularly among switch patients, based on compelling clinical data [60][63] Question: Gene therapy strategies and differentiation - Management clarified that gene therapy programs will not move into the clinic in the near term, focusing instead on core science and technology [67][71]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 Jurisdicti ...

| --- | --- | --- | --- | --- | --- | --- | --- | |--------------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 40th Annual J.P. Morgan Healthcare Conference | | | | | | | | | At the Forefront of Therapies | | | | | | | | | January 12, 2022 for Rare Diseases | | | | | | | | 2 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Priva ...