Amicus Therapeutics(FOLD) - 2022 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION 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) 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 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 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 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 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][30] - The FDA extended the PDUFA action dates for AT-GAA components to August 29, 2022, and October 29, 2022[30] - The company believes its current cash position, including expected revenues, is sufficient to fund operations to achieve self-sustainability[31] - An impairment charge of $6.6 million was recognized in Q1 2022 due to the strategic prioritization of its gene therapy portfolio[46] 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 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][94] - 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] 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] - Total cash, cash equivalents, and marketable securities as of March 31, 2022, was $411.2 million[85][99] Item 3. Quantitative and Qualitative Disclosures about Market Risk 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] Item 4. Controls and Procedures 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] - No material changes were made to the company's internal control over financial reporting during the quarter[118] PART II. OTHER INFORMATION 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 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] - 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] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[123] Item 4. Mine Safety Disclosures The company reported no mine safety disclosures - None[124] Item 5. Other Information The company reported no other information - None[125] Item 6. Exhibits 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] Signatures This section contains the required signatures, affirming the accuracy and completeness of the filed report