Amicus Therapeutics (FOLD) came out with quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.08 per share. This compares to loss of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -62.50%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.10 per share when it actually produced earnings of $0.09, delivering a surprise of -10%.Over the last four quarters ...

Amicus Therapeutics (FOLD) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics first quarter twenty twenty five financial results conference call and webcast. At this time, participants are in a listen only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call, it is being recorded. I would now like to turn the conference call over to your host, ...

AT THE FOREFRONT OF THERAPIES FOR RARE DISEASES 1Q25 Results Conference Call & Webcast May 1, 2025 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the prospects and timing of the potential regulatory and pricing approval of our products, commercialization plans, manufacturing and supply plans, financing plans, the collaboration with Dimerix, and the projected revenues and cash position f ...

Exhibit 99.1 Amicus Therapeutics Announces First Quarter 2025 Financial Results and Corporate Updates 1Q 2025 Total Revenue of $125.2M, a 15% Increase Year-over-Year at CER Expanding Portfolio through In-Licensing of DMX-200 Phase 3 Program for Rare Kidney Disease with Significant Market Potential in the U.S. Maintaining 2025 Guidance for Galafold, Reflecting Strong Underlying Demand Updating 2025 Pombiliti + Opfolda Guidance with New Patient Starts Accelerating in 2H Adjusting 2025 Total Revenue Growth Gui ...

1Q 2025 Total Revenue of $125.2M, a 15% Increase Year-over-Year at CER Expanding Portfolio through In-Licensing of DMX-200 Phase 3 Program for Rare Kidney Disease with Significant Market Potential in the U.S. Maintaining 2025 Guidance for Galafold, Reflecting Strong Underlying Demand Updating 2025 Pombiliti + Opfolda Guidance with New Patient Starts Accelerating in 2H Adjusting 2025 Total Revenue Growth Guidance to 15-22% at CER Reiterating GAAP Profitability During H2 2025 Conference Call and Webcast Toda ...

Amicus licenses exclusive U.S. rights to commercialize DMX-200 for the treatmentof Focal Segmental Glomerulosclerosis (FSGS) DMX-200 is in a pivotal Phase 3 trial for FSGS, a rare and fatal kidney disease with no FDA-approved therapies Dimerix successfully completed Type C meeting with the FDA in March 2025, aligning on proteinuria as the primary endpoint for approval Dimerix to receive US$30 million (~AU$48 million) upfront payment, up to US$560 million (~AU$892 million) for success-based milestone paymen ...

I covered Amicus Therapeutics, Inc. (NASDAQ: FOLD ) two years ago, when it was waiting for approval for the Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) program in Pompe Disease. That approval happened a month after myAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material ...

Core Points - The U.S. Court of Appeals for the D.C. Circuit has stayed a district court's permanent injunction, allowing President Trump to remove Hampton Dellinger from the U.S. Office of Special Counsel [1] - Dellinger announced he will end his lawsuit following the circuit court's ruling, which affirms the President's authority to remove top executive branch officials [1][3] - The New Civil Liberties Alliance (NCLA) supports the D.C. Circuit's decision, emphasizing the President's constitutional authority to remove executive officials [1][4] Summary by Sections Legal Authority - The Constitution grants the President broad authority to remove executive branch officials, as confirmed by the Supreme Court in the 2020 Seila Law case [2] - The removal authority is essential for the President to ensure that laws are faithfully executed, and there are no constitutional limits on this power [2][3] Court Rulings - A federal district court judge overstepped by attempting to bar the President from firing a top executive branch official, which is a violation of the President's Article II authority [3] - The D.C. Circuit's reversal of the district court's decision is seen as a correction of judicial overreach [3] NCLA Statements - NCLA representatives expressed satisfaction with the D.C. Circuit's decision, highlighting the importance of maintaining the separation of powers [4][5] - The organization criticized the district court's attempt to dictate who serves in the Executive Branch, reaffirming that executive power resides with the President [4]

Core Insights - Amicus Therapeutics will participate in several investor conferences in March 2025, indicating active engagement with the investment community [1][4] Company Overview - Amicus Therapeutics is a global biotechnology company dedicated to developing high-quality medicines for rare diseases, emphasizing patient focus and innovation [3] - The company aims to advance a pipeline of first- or best-in-class medicines, showcasing its commitment to addressing unmet medical needs in rare diseases [3] Upcoming Events - The company will present at the TD Cowen 45th Annual Health Care Conference in Boston, MA, on March 4, 2025, at 9:50 a.m. ET [4] - Additionally, Amicus Therapeutics will participate in the Leerink Partners 2025 Global Healthcare Conference in Miami, FL, on March 10, 2025, at 10:00 a.m. ET [4]

Core Viewpoint - Amicus Therapeutics reported mixed financial results for Q4 2024, with adjusted earnings missing estimates but revenues showing significant year-over-year growth driven by product sales, particularly from Galafold and the newly approved Pombiliti + Opfolda [1][2][3]. Financial Performance - Adjusted earnings for Q4 2024 were 9 cents per share, below the Zacks Consensus Estimate of 10 cents, compared to 1 cent per share in the same quarter last year [1]. - Revenues for Q4 totaled $149.7 million, reflecting a 30% increase year over year, slightly exceeding the Zacks Consensus Estimate of $149 million [2]. - Galafold sales reached $127.5 million in Q4, up 20% year over year at constant currency, but fell short of the Zacks Consensus Estimate of $141 million [5]. - Net product sales of Pombiliti + Opfolda were $22.2 million, showing a sequential growth of 5.2%, narrowly missing the Zacks Consensus Estimate of $22.3 million [6]. Full-Year Results - For the full year 2024, Amicus generated revenues of $528.3 million, a 33% increase year over year [9]. - The company reported adjusted earnings of 24 cents per share, a significant improvement from a loss of 13 cents per share in the previous year [9]. 2025 Guidance - Amicus reiterated its revenue guidance for 2025, expecting total revenues to grow between 17%-24% on a constant exchange rate [10]. - Revenue from Galafold is anticipated to grow by 10%-15% at constant exchange rates in 2025, while Pombiliti + Opfolda is expected to see growth of 65%-85% [10]. - Total adjusted operating expenses are projected to be between $350 million and $370 million [10]. Cash Position - As of December 31, 2024, Amicus had cash, cash equivalents, and marketable securities totaling $249.9 million, slightly up from $249.8 million as of September 30, 2024 [8]. Patent Litigation Settlement - In October 2024, Amicus signed a licensing agreement with Teva Pharmaceuticals, resolving a patent lawsuit regarding Galafold, preventing Teva from selling a generic version until January 2037 [12][13].