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 ...

Amicus Therapeutics (FOLD) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 100%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $0.06 per share when it actually produced a loss of $0.02, delivering a surprise of 66.67%. Over the last four quarters, t ...

The Board of Governors of the Federal Reserve System (the Fed) adopted Regulation II in 2011, establishing fees for debit-card transactions. Corner Post began operating in 2018 and filed its lawsuit challenging Regulation II in 2021, claiming it had incurred excessive interchange fees under the rule. The U.S. Court of Appeals for the Eighth Circuit ruled that Corner Post's opportunity to file suit had expired in 2017, six years after the rule first issued. "Because an APA plaintiff may not file suit and obt ...

Core Viewpoint - The U.S. Court of Appeals for the Tenth Circuit has reversed a district court decision regarding warrantless searches of dog training businesses, indicating potential violations of the Fourth Amendment rights of the appellants [1]. Group 1: Legal Context - The New Civil Liberties Alliance (NCLA) filed an amicus curiae brief arguing that the Kansas state law allowing warrantless searches infringes on the Fourth Amendment rights of individuals [1]. - The Tenth Circuit affirmed the dismissal of the claim regarding the right to travel but remanded the case to determine the applicability of the Fourth Amendment to warrantless searches of dog training businesses [1][4]. Group 2: Case Background - Scott Johnson and Harlene Hoyt operate Covey Find Kennel, a licensed dog training business, which is subject to unannounced inspections under the Kansas Pet Animal Act [2]. - The law requires one of the owners to be present for inspections with only 30 minutes' notice, allowing the Kansas Department of Agriculture to conduct searches without probable cause [2]. Group 3: Court's Reasoning - The Tenth Circuit found insufficient information to determine if Covey Find Kennel is a "closely regulated" business exempt from Fourth Amendment protections, criticizing the district court's broad application of this exception [4]. - The court's decision prevents the potential for widespread intrusions across various regulated industries in Kansas [4]. Group 4: NCLA's Position - NCLA argues that applying the Fourth Amendment exception for closely regulated businesses to dog training facilities is unreasonable and should be rejected by the district court [5]. - NCLA emphasizes the need to protect constitutional rights from being overridden by state licensing requirements [3].

Washington, D.C., June 05, 2024 (GLOBE NEWSWIRE) -- Today, the U.S. Court of Appeals for the Fifth Circuit issued a decision in National Association of Private Fund Managers v. Securities and Exchange Commission vacating SEC's recent final rule restricting—and in some cases prohibiting—certain common contractual agreements between private investment funds and investment advisers. Following the New Civil Liberties Alliance amicus curiae brief's advice, the Court declared that SEC exceeded its statutory autho ...