Amicus Therapeutics(US:FOLD) ZACKS·2025-11-05 16:11Core Insights - Amicus Therapeutics (FOLD) reported adjusted earnings of 17 cents per share for Q3 2025, surpassing the Zacks Consensus Estimate of 12 cents and up from 10 cents in the same quarter last year [1][6] - Revenues for Q3 totaled $169.1 million, reflecting a 19% year-over-year increase and exceeding the Zacks Consensus Estimate of $165 million [2][6] - The revenue growth was driven by sales of Galafold and the newly approved combination therapy Pombiliti + Opfolda, which is aimed at treating late-onset Pompe disease [2][3] Financial Performance - Galafold sales reached $138.3 million, a 12% increase year-over-year at constant exchange rates, although it fell short of the Zacks Consensus Estimate of $150 million [4][6] - Sales of Pombiliti + Opfolda amounted to $30.7 million, surpassing both the Zacks Consensus Estimate of $29.7 million and the internal estimate of $29.4 million [7] - Adjusted operating expenses rose by 15% to $95.4 million in Q3 2025, while cash and marketable securities increased to $263.8 million from $231 million as of June 30, 2025 [7] Guidance and Future Outlook - Amicus reaffirmed its 2025 guidance, projecting total revenue growth of 15-22% at constant exchange rates, with Galafold expected to grow by 10-15% and Pombiliti + Opfolda by 50-65% [8] - The company anticipates achieving positive GAAP net income in the second half of 2025 and aims to exceed $1 billion in total sales by 2028 [9] Recent Developments - Amicus licensed exclusive rights for Dimerix's phase III program, DMX-200, in the U.S., targeting FSGS, a rare kidney disease, with the pivotal ACTION3 study on track for full enrollment by the end of 2025 [10]