Core Insights - Amicus Therapeutics (FOLD) has signed a licensing agreement with Teva Pharmaceuticals (TEVA), resolving a patent lawsuit related to its drug Galafold, leading to a 14% increase in FOLD's stock price [1][2]. Group 1: Licensing Agreement and Litigation - The agreement allows Teva to sell a generic version of Galafold in the U.S. starting January 30, 2037, pending FDA approval [2]. - The settlement ends all ongoing litigation between Amicus and Teva regarding Galafold patents, but litigation against Aurobindo Pharma continues [2]. Group 2: Galafold Performance - Galafold, Amicus' lead drug, generated $210.2 million in sales in the first half of 2024, reflecting a 17% year-over-year increase at constant currency [5]. - Amicus has raised its revenue guidance for Galafold for 2024 to a growth range of 14-18%, up from the previous 13-17% [5]. - The drug is protected by a strong intellectual property portfolio in the U.S. until 2038, with potential for label expansion and approvals in new markets [5]. Group 3: Additional Drug Portfolio - Amicus has a second FDA-approved drug, Pombiliti + Opfolda, for treating late-onset Pompe disease, which was approved in September 2023 [6]. - The approval of Pombiliti + Opfolda provides significant commercial opportunities and alleviates revenue pressure on Galafold [6]. Group 4: Stock Performance and Rankings - Year-to-date, FOLD shares have decreased by 15.6%, while the industry has seen a decline of 1.3% [4]. - Amicus currently holds a Zacks Rank 1 (Strong Buy), indicating positive market sentiment [7].

Amicus Therapeutics (FOLD) shares ended the last trading session 14% higher at $11.97. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 3.8% loss over the past four weeks. The sudden rise in the stock price was observed after Amicus announced signing a licensing agreement with Teva Pharmaceuticals which resolves the patent lawsuit filed earlier by FOLD. The litigation arose after Teva submitted an abbreviated new dr ...

PRINCETON, N.J., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced that three posters highlighting its development program for Pompe disease will be included at the 29th Annual Congress of the World Muscle Society being held October 8-12, 2024 in Prague, Czechia. Poster Session: Pompe Disease Abstract Title: Cipaglucosidase alfa + miglustat in late-onset Pompe disease: two non-ambulatory patients switching from high-dose, high-frequency alglucosidase alfa (Poster #657P) P ...

PRINCETON, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in September. Morgan Stanley 22nd Annual Global Healthcare Conference in New York, NY, on Thursday, September 5, 2024, at 10:00 a.m. ET Cantor Global Healthcare Conference 2024 in New York, NY on Tuesday, September 17, 2024, at 1:55 p.m. ET A live audio webcast of each presentation can also be accessed via the ...

PRINCETON, N.J., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in September. Morgan Stanley 22nd Annual Global Healthcare Conference in New York, NY, on Thursday, September 5, 2024, at 10:00 a.m. ET Cantor Global Healthcare Conference 2024 in New York, NY on Tuesday, September 17, 2024, at 1:55 p.m. ET A live audio webcast of each presentation can also be accessed via the i ...

NicoElNino/iStock via Getty Images Amicus Therapeutics, Inc. (NASDAQ:FOLD) focuses on rare and orphan diseases, particularly Fabry and Pompe. The company's portfolio includes Galafold and Pombiliti. Notably, Galafold is an oral treatment that seems effective for Fabry by stabilizing the dysfunctional enzyme alpha-Gal A. FOLD's Pombiliti is a combination therapy with Opfolda, indicated for Pompe disease. Pombiliti replaces and stabilizes deficient or dysfunctional GAA enzymes needed for glycogen breakdown, h ...

Amicus Therapeutics (FOLD) reported second-quarter 2024 adjusted earnings of 6 cents per share, beating the Zacks Consensus Estimate of 3 cents. The company had incurred a loss of 7 cents per share in the year-ago quarter. Please note that the company achieved non-GAAP profitability for the first time in the reported quarter. The year-over-year improvement can be attributed to higher revenues from Galafold (migalastat) sales and incremental revenues from the sale of the newly approved combo drug, Pombiliti ...

| --- | --- | --- | --- | |--------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | AT THE FOREFRONT OF THERAPIES FOR RARE DISEASES | | | | | 2Q24 Results Conference Call & Webcast | | | | | August 8, 2024 | | | | | | | | | 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 can ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 reached $127 million, representing a 34% year-over-year growth or 36% on a constant currency basis [6][30] - The company has increased its total revenue guidance for the full year to 26% to 31%, up from the previous range of 25% to 30% [6][32] - Non-GAAP net income for Q2 was $18 million or $0.06 per share, compared to a loss of $20 million or $0.07 per share in the same period last year [32] Business Line Data and Key Metrics Changes - Galafold generated $111 million in global revenue for the quarter, reflecting a 19% growth year-over-year on a constant currency basis [7][14] - Pombiliti and Opfolda reported revenue of $16 million for Q2 2024, marking a 44% increase compared to Q1 2024 [20][21] Market Data and Key Metrics Changes - The U.S. market saw the highest number of net new patients for Galafold in over five years, indicating strong demand [14][19] - The company holds over 60% of the global market share for treated Fabry patients with amenable mutations [13][14] Company Strategy and Development Direction - The company aims to sustain double-digit revenue growth for Galafold and maximize the number of patients on therapy for Pombiliti and Opfolda by year-end [13][24] - Amicus is focused on expanding into new markets and enhancing patient access through reimbursement efforts [10][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year non-GAAP profitability in 2024, supported by strong commercial execution and revenue growth [12][33] - The company anticipates continued growth driven by increased patient identification and improved diagnosis in the Fabry market [18][63] Other Important Information - The Swissmedic approved Pombiliti and Opfolda for adults with late-onset Pompe disease in July 2024 [11][22] - The company has narrowed its full-year 2024 non-GAAP operating expense guidance to $345 million to $360 million [33] Q&A Session Summary Question: How should the cadence of the Europe launch be compared to the U.S. launch? - Management noted that both markets are progressing well, with the U.S. expected to see a stronger rate of new patients due to its size, while Europe is adding new countries and gaining traction [36] Question: What trends are seen in patients switching from Nexviazyme? - The majority of patients switching from Nexviazyme have been on treatment for one to two years, with some switching earlier due to positive word-of-mouth [42] Question: Are there regional variations in Galafold growth? - Strong growth is observed in all key markets, particularly in the U.S. and Japan, with a growing proportion of newly diagnosed patients being treated with Galafold [46][49] Question: What is the current status of the Pom-Opf launch? - The rate of new patients is expected to build momentum as new countries are opened, with a focus on maximizing the number of patients on therapy by year-end [52] Question: How is the competitive landscape with Genzyme's Nexviazyme? - Management emphasized the unique efficacy of Pombiliti and Opfolda, highlighting improvements shown in clinical trials compared to competitors [55][56] Question: What is the status of insurance coverage for Opfolda? - There have been no reported denials for coverage of either component, with improvements in the time from prescription to infusion [59]

Amicus Therapeutics (FOLD) reported $126.67 million in revenue for the quarter ended June 2024, representing a year-over-year increase of 34%. EPS of $0.06 for the same period compares to -$0.15 a year ago. The reported revenue represents a surprise of +4.90% over the Zacks Consensus Estimate of $120.76 million. With the consensus EPS estimate being $0.03, the EPS surprise was +100.00%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare t ...