Amicus Therapeutics(FOLD) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Consolidated Financial Statements and Notes (unaudited) This section provides unaudited consolidated financial statements, highlighting product sales growth, increased net loss for the quarter, and decreased cash Consolidated Balance Sheets Total assets increased to $815.3 million by June 30, 2025, while cash and equivalents decreased to $158.7 million Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $158,702 | $213,752 | | Total current assets | $538,007 | $504,736 | | Total Assets | $815,303 | $785,033 | | Total current liabilities | $167,647 | $148,702 | | Long-term debt | $391,322 | $390,111 | | Total Liabilities | $610,999 | $590,988 | | Total stockholders' equity | $204,304 | $194,045 | Consolidated Statements of Operations Net product sales grew to $154.7 million in Q2 2025, but increased R&D expenses led to a $24.4 million net loss Quarterly Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net product sales | $154,688 | $126,669 | | Gross profit | $139,471 | $115,408 | | Research and development | $60,848 | $24,683 | | Selling, general, and administrative | $84,543 | $73,576 | | Loss from operations | $(9,474) | $14,967 | | Net loss | $(24,420) | $(15,697) | | Net loss per share | $(0.08) | $(0.05) | Six-Month Statement of Operations (in thousands, except per share data) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net product sales | $279,937 | $237,072 | | Gross profit | $253,022 | $212,244 | | Research and development | $88,687 | $53,012 | | Selling, general, and administrative | $176,370 | $161,605 | | Loss from operations | $(17,426) | $(12,754) | | Net loss | $(46,106) | $(64,116) | | Net loss per share | $(0.15) | $(0.21) | Consolidated Statements of Cash Flows Net cash used in operating activities increased to $18.8 million for H1 2025, resulting in a $54.7 million net cash decrease Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,768) | $(7,004) | | Net cash used in investing activities | $(38,639) | $(14,440) | | Net cash used in financing activities | $(12,100) | $(14,166) | | Net decrease in cash | $(54,701) | $(37,720) | | Cash at end of period | $162,015 | $212,357 | Notes to Consolidated Financial Statements Notes detail business operations, accounting policies, product revenue growth, and the $30 million Dimerix licensing agreement - The company markets Galafold® and Pombiliti® + Opfolda® for rare diseases, approved in major global markets[33] - An exclusive license agreement with Dimerix for DMX-200 involved a $30 million upfront payment and up to $560 million in potential milestones[33][65] Net Product Sales by Product and Geography (in thousands) | Product/Region | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Galafold® sales | $128,872 | $110,817 | $233,116 | $210,176 | | - Galafold® U.S. | $53,600 | $42,770 | $93,766 | $76,885 | | - Galafold® Ex-U.S. | $75,272 | $68,047 | $139,350 | $133,291 | | Total Pombiliti® + Opfolda® sales | $25,816 | $15,852 | $46,821 | $26,896 | | - Pombiliti® + Opfolda® U.S. | $10,730 | $7,368 | $20,557 | $10,628 | | - Pombiliti® + Opfolda® Ex-U.S. | $15,086 | $8,484 | $26,264 | $16,268 | | Total net product sales | $154,688 | $126,669 | $279,937 | $237,072 | - Inventories increased to $154.9 million by June 30, 2025, from $118.8 million at year-end 2024, supporting commercial growth[62] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial performance, strategic progress, and liquidity, highlighting commercial growth and the DMX-200 licensing deal Overview and Strategy The company's strategy focuses on developing and commercializing rare disease therapies, expanding its pipeline with DMX-200 - The company's strategy involves developing and delivering high-quality rare disease medicines through various means[82] - Pipeline advancement includes licensing exclusive U.S. commercialization rights for DMX-200, a Phase 3 candidate for FSGS[81][88] - Continued focus remains on Fabry and Pompe disease franchises, with ongoing discovery for next-generation therapies[82][90] Consolidated Results of Operations Q2 2025 net product sales increased 22% to $154.7 million, while R&D expenses surged due to a $30.0 million license payment Q2 2025 vs Q2 2024 Financial Comparison (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $154,688 | $126,669 | $28,019 | | Research and development | $60,848 | $24,683 | $36,165 | | Selling, general, and administrative | $84,543 | $73,576 | $10,967 | | Net loss | $(24,420) | $(15,697) | $(8,723) | - The $36.2 million increase in Q2 R&D costs was primarily due to the $30.0 million upfront Dimerix license payment[93] H1 2025 vs H1 2024 Financial Comparison (in thousands) | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $279,937 | $237,072 | $42,865 | | Research and development | $88,687 | $53,012 | $35,675 | | Selling, general, and administrative | $176,370 | $161,605 | $14,765 | | Net loss | $(46,106) | $(64,116) | $18,010 | Liquidity and Capital Resources The company held $231.0 million in cash and equivalents, with $18.8 million net cash used in operations for H1 2025 - Total cash, cash equivalents, and marketable securities amounted to $231.0 million as of June 30, 2025[88][102] - Net cash used in operations for H1 2025 was $18.8 million, reflecting net loss and increased inventory[103] - An at-the-market (ATM) equity program has $164.2 million remaining capacity as of June 30, 2025[101] - Management believes current cash is sufficient to fund operations and research programs for at least the next 12 months[110] Item 3. Quantitative and Qualitative Disclosures about Market Risk No material changes to market risks or their management have occurred since December 31, 2024 - No material changes to the company's market risks have occurred since December 31, 2024[115] Item 4. Controls and Procedures Disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Disclosure controls and procedures were concluded effective by key officers as of the reporting period end[116] - No material changes to internal control over financial reporting occurred during the last fiscal quarter[117] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is involved in Hatch-Waxman litigation for Galafold®, settling with Teva while continuing cases against others - Litigation is ongoing against Teva, Aurobindo, and Lupin concerning generic Galafold® ANDA filings[118] - A settlement with Teva grants a generic Galafold® license in the U.S. starting January 30, 2037, resolving their litigation[119] - Litigation remains active against Aurobindo, with a stay in place for the Lupin case[119] Item 1A. Risk Factors No material changes to risk factors were reported compared to the prior Annual Report on Form 10-K - No material changes to risk factors were reported compared to the Annual Report on Form 10-K for fiscal year 2024[120] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred, but 28,748 shares were purchased to cover tax obligations - No unregistered sales of equity securities occurred during the period[121] Issuer Purchases of Equity Securities (Q2 2025) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2025 | 4,374 | $6.92 | | May 2025 | 16,494 | $6.31 | | June 2025 | 7,880 | $6.04 | | Total | 28,748 | $6.33 | - Purchased shares represent common stock withheld to satisfy taxes from restricted stock unit vesting[122] Item 5. Other Information No Rule 10b5-1 trading arrangement changes occurred, and the Cash Deferral Plan was frozen by the Board - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[125] - The Board of Directors froze the company's Cash Deferral Plan on July 29, 2025, preventing new deferrals[126] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including the Equity Incentive Plan and Dimerix license agreement - Key exhibits include the 2025 Equity Incentive Plan, loan agreement amendments, and the Dimerix Biosciences license agreement[128]