Amicus Therapeutics(FOLD) - 2024 Q4 - Annual Report

Financial Performance - Net product sales increased by $128.9 million to$528.3 million in 2024, driven by growth in Galafold and the launch of Pombiliti + Opfolda[330]. - Net product sales for 2024 reached $528,295, an increase of 32.4$399,356 in 2023[391]. - Gross profit for 2024 was $475,352, reflecting a gross margin of approximately 90$56,106, a significant improvement from a loss of $151,584 in 2023[391]. - The net loss for the year ended December 31, 2024, was$56,106 thousand, a decrease from the net loss of $151,584 thousand in 2023 and$236,568 thousand in 2022, indicating a 63.0% improvement year-over-year[399]. - The Company reported a total income (loss) before income taxes of $(28.8) million for 2024, an improvement from$(150.1) million in 2023[497]. Expenses - Cost of goods sold as a percentage of net product sales rose to 10.0% in 2024 from 9.3% in 2023, primarily due to inventory write-offs[330]. - Research and development expenses decreased by $43.0 million to$109.4 million, mainly due to reduced clinical spending following the commercial launch of Pombiliti + Opfolda[331]. - Selling, general, and administrative expenses increased by $48.1 million to$323.4 million, attributed to higher personnel costs for commercial launch activities[331]. - The total operating expenses for 2024 were $450,476, slightly higher than$439,241 in 2023[391]. - The total stock-based compensation expense for 2024 was $84,905 thousand, slightly lower than$86,077 thousand in 2023[399]. - The Company incurred approximately $32.7 million in royalty expenses under the GSK collaboration agreement for the year ended December 31, 2024[506]. Cash Flow and Financing - Cash, cash equivalents, and marketable securities totaled$249.9 million as of December 31, 2024[343]. - Net cash used in operating activities was $33.9 million in 2024, a decrease from$69.1 million in 2023[344][345]. - The company issued 1,732,204 shares through its ATM program, generating net proceeds of $19.6 million in 2024[341]. - The company prepaid the Senior Secured Term Loan due 2026, recognizing a loss on extinguishment of debt of$13.9 million[333]. - Net cash provided by financing activities for the year ended December 31, 2023 was $61.7 million, primarily reflecting$387.4 million from a Senior Secured Loan due in 2029[349]. - The company raised $19,566 thousand from the issuance of shares in connection with at-the-market offerings in 2024, compared to$63,108 thousand in 2023[399]. Assets and Liabilities - Total assets as of December 31, 2024, were $785,033, a slight increase from$777,880 in 2023[389]. - Total liabilities decreased to $590,988 in 2024 from$617,706 in 2023, a reduction of 4.3%[389]. - Stockholders' equity increased to $194,045 in 2024, up from$160,174 in 2023, reflecting a growth of 21.1%[389]. - The company had an accumulated deficit of $2.7 billion as of December 31, 2024, and anticipates continuing to incur losses into the second half of 2025[403]. - The company reported accrued expenses and other current liabilities of$127.3 million as of December 31, 2024, a decrease from $144.2 million in 2023[464]. Research and Development - Total research and development costs for 2024 were$109.4 million, down from $152.4 million in 2023[331]. - Research and development expenses decreased to$109,362 in 2024 from $152,381 in 2023, a reduction of 28.2$390.1 million as of December 31, 2024, compared to $387.9 million in 2023, reflecting a slight increase[486]. - The Senior Secured Term Loan due 2029 has a principal amount of$400 million with an effective interest rate of 12.0% for 2024, down from 12.8% in 2023[491]. - Interest expense for the Company was $47.4 million in 2024, slightly decreasing from$47.6 million in 2023[491]. Commitments and Contingencies - The company has binding minimum purchase and manufacturing commitments totaling $179.7 million, with$102.7 million and $77.0 million expected in 2025 and 2026, respectively[354]. - The Company has a contingent milestone payment of$4.7 million due to GSK as of December 31, 2024[505]. Tax and Regulatory - The gross unrecognized tax benefits increased to $13.8 million in 2024 from$4.9 million in 2023, indicating a significant rise in uncertain tax positions[499]. - Deferred tax assets totaled $617.2 million in 2024, with a valuation allowance of the same amount, reflecting uncertainty regarding the realization of these assets[500]. - The Company has U.S. federal research and experimentation credit carryforwards of approximately$19.1 million, expiring between 2030 and 2043[502]. - The Company has state research and development tax credit carryforwards of $13.5 million, subject to a full valuation allowance[502]. - The Company does not expect the OECD's BEPS Pillar 2 rules to apply until it meets the minimum global revenue threshold[504]. Miscellaneous - The Company operates in one business segment focused on advanced therapies for rare diseases, with performance evaluated based on net product sales and net loss[441]. - The Company entered into a non-exclusive license with Teva allowing them to market a generic version of Galafold in the U.S. starting January 30, 2037[508].