分组1 - Amicus Therapeutics reported quarterly earnings of $0.09 per share, missing the Zacks Consensus Estimate of $0.10 per share, compared to a loss of $0.11 per share a year ago, representing an earnings surprise of -10% [1] - The company posted revenues of $149.71 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.13%, and this is an increase from year-ago revenues of $115.08 million [2] - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $141.25 million, and for the current fiscal year, it is $0.43 on revenues of $638.94 million [7] 分组2 - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the top 28% of over 250 Zacks industries, indicating that the industry is performing well [8] - Amicus Therapeutics has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates two times in the same period [2] - The stock has added about 3.7% since the beginning of the year, compared to the S&P 500's gain of 4% [3]

Revenue Growth - Total revenue for FY 2024 reached approximately $528 million, representing a 32% growth compared to the previous year[4] - Full-Year 2025 total revenue growth guidance is projected to be between 17% to 24%[55] - Galafold revenue growth is expected to be between 10% to 15% for FY 2025[55] - Pombiliti and Opfolda revenue growth is anticipated to be between 65% to 85% for FY 2025[55] Market Potential - The global Fabry market is expected to grow from approximately $2.1 billion in 2024 to over $3 billion by 2029, driven by improved diagnosis and treatment rates[10][11] - The global Pompe disease market is projected to grow from approximately $1.5 billion in 2024 to over $2 billion by 2029, driven by increased diagnosis and treatment[29] Patient Demographics - The number of patients treated for Fabry disease has more than doubled since 2015, with approximately 12,000 currently treated in the U.S.[13][22] - The company has identified over 100,000 undiagnosed individuals with Fabry disease in the U.S., highlighting a significant unmet need in the market[21] - The company serves over 3,000 patients living with rare diseases[52] Product Performance - Galafold continues to be the leading oral treatment for Fabry disease, capturing over 60% of the share among treated amenable patients[15] - Pombiliti and Opfolda generated $70.3 million in revenue in FY 2024, with expectations of 65-85% growth in FY 2025[49] Clinical Development - Ongoing clinical studies are focused on expanding the label for Pombiliti and Opfolda, with evidence generation supporting their differentiated mechanism of action[46] Geographic Expansion - The company anticipates launching in up to 10 new countries in 2025, expanding access to therapies for over 650 late-onset Pompe disease patients[44] - The company has expanded access to 40 patients across 16 countries as of November 2024[60] Financial Considerations - A 4% variance in USD exchange rates could negatively impact total revenue by approximately $15 million in 2025[57] - Approximately 60% of the company's revenue is generated outside the U.S.[55] Commitment to Pricing - The company has committed to never raising the annual price of its products more than consumer inflation[60] Community Engagement - As of December 31, 2023, the company has allocated $1,980,516 to U.S. community programs[60] Revenue Distribution - The average quarterly distribution of Galafold revenue over the past 5 years shows Q4 at 28%[58]

Core Insights - Amicus Therapeutics reported total revenue of $528.3 million for the year 2024, marking a 33% increase year-over-year [1][4][3] - The company projects revenue growth for 2025 to be between 17% and 24% at constant exchange rates (CER) [1][4][7] - Amicus anticipates achieving positive GAAP net income during the second half of 2025 [1][7][12] Financial Performance - Total revenues for 2024 were $528.3 million, with a fourth-quarter revenue of $149.7 million, reflecting a 30% increase year-over-year [4][5] - Galafold® net product sales for 2024 were $458.1 million, an 18% increase year-over-year, while Pombiliti® + Opfolda® sales reached $70.2 million, a significant increase of 507% [5][6][12] - The company reported a GAAP net loss of $56.1 million for 2024, an improvement from a loss of $151.6 million in 2023 [12][24] Product Insights - Galafold is indicated for treating Fabry disease and is approved in over 40 countries, with approximately 2,730 patients using the drug by the end of 2024 [12][13] - Pombiliti + Opfolda received regulatory approval in multiple countries, including Australia, and is expected to see first commercial patients treated in early 2025 [5][12][16] Future Guidance - For 2025, Amicus expects Galafold revenue growth of 10% to 15% and Pombiliti + Opfolda growth of 65% to 85% at CER [7][12] - The company aims to surpass $1 billion in total sales by 2028, driven by its current product portfolio [6][12] Operational Highlights - Total GAAP operating expenses for 2024 were $450.5 million, a slight increase from $439.2 million in 2023 [12][24] - Cash, cash equivalents, and marketable securities totaled $249.9 million at the end of 2024, showing stability compared to previous quarters [12][24]

2024 Total Revenue of $528.3M, a 33% Increase Year-over-Year Projecting 2025 Total Revenue Growth of 17-24% at CER Anticipate Achieving Positive GAAP Net Income During H2 2025 Conference Call and Webcast Today at 8:30 a.m. ET PRINCETON, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the full-year ended December 31, 2 ...

NEW YORK, Feb. 17, 2025 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Amicus Therapeutics, Inc. (NASDAQ:FOLD) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. If you are a long-term FOLD stockholder please contact Justin Kuehn, Esq. here, by email at justin@kuehn.law, or call (833) 672-0814.  The cons ...

Core Insights - Amicus Therapeutics (FOLD) is expected to report quarterly earnings of $0.10 per share, reflecting a year-over-year increase of 190.9% [1] - Anticipated revenues for the quarter are projected to be $149.53 million, representing a 29.9% increase compared to the same quarter last year [1] Earnings Estimates Revision - The consensus EPS estimate for the quarter has been revised downward by 80% over the past 30 days, indicating a significant reassessment by analysts [2] - Revisions to earnings estimates are crucial indicators for predicting investor actions regarding the stock [3] Revenue Projections - Analysts predict 'Net Product Revenues- Galafold' will reach $140.98 million, showing a year-over-year change of +32.3% [5] - 'Geographic revenues- Ex-U.S' are expected to be $94.04 million, indicating a +30.8% change from the previous year [5] - 'Geographic revenues- United States' are forecasted to be $55.85 million, suggesting a +29.4% year-over-year change [5] Stock Performance - Over the past month, Amicus Therapeutics shares have recorded a return of +3.8%, compared to the Zacks S&P 500 composite's +4.7% change [6] - Based on its Zacks Rank 3 (Hold), FOLD is likely to perform in line with the overall market in the upcoming period [6]

Wall Street expects a year-over-year increase in earnings on higher revenues when Amicus Therapeutics (FOLD) reports results for the quarter ended December 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on February 19, 2025, might help the stock move higher if these key numbers are bet ...

PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, February 19, 2025, at 8:30 a.m. ET to discuss financial results for the full-year ended December 31, 2024. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal ...

PRINCETON, N.J., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced that two oral presentations and 20 posters across its development programs will be included at the 21st Annual WORLDSymposium™ 2025, being held February 3-7, 2025 in San Diego, CA. “As part of our ongoing efforts to advance our scientific leadership in Fabry and Pompe diseases, Amicus researchers will present two oral presentations and 20 posters at this year’s WORLDSymposium,” said Bradley Campbell, Presi ...

Washington, D.C., Jan. 23, 2025 (GLOBE NEWSWIRE) -- The New Civil Liberties Alliance has filed an amicus curiae brief in Burgess v. Whang, urging the U.S. Court of Appeals for the Fifth Circuit to uphold a preliminary injunction stopping the Federal Deposit Insurance Corporation’s (FDIC) unconstitutional administrative enforcement proceeding against Cornelius Campbell Burgess. FDIC is trying to heavily fine Mr. Burgess, a former executive for a small Texas bank, and ban him from the banking industry for lif ...