Business
PTC Therapeutics Provides Corporate Update and Reports Second Quarter Financial Results
– Second-quarter 2023 total revenue of $214 million, representing 29% year-over-year growth – – Positive APHENITY and PIVOT-HD data readouts in the second
About this update from Ptc Therapeutics, Inc.
[{"type":"text","content":"– Second-quarter 2023 total revenue of $214 million, representing 29% year-over-year growth –\n– Positive APHENITY and PIVOT-HD data readouts in the second quarter –\n– Numerous regulatory milestones planned for the second half of 2023 – \nSOUTH PLAINFIELD, N.J., Aug. 3, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and financial results for the second quarter ending June 30, 2023. \n\"I am extremely proud of the revenue growth in the first half of 2023 providing us confidence that we will meet our full-year total revenue guidance,\" said Matthew Klein, M.D., Chief Executive Officer, PTC Therapeutics, Inc. \"In addition, the great results from the APHENITY and PIVOT-HD trials position us well for future growth.\" \nKey Corporate Updates: \nSecond quarter 2023 revenue for the Duchenne muscular dystrophy (DMD) franchise was $162 million, representing 21% year-over-year growth.Translarna™ (ataluren) quarterly net product revenue was $96 million, with growth coming from treatment of new patients and continued geographic expansion.Emflaza® (deflazacort) quarterly net product revenue was $66 million, driven by new patients, and high compliance.Key Clinical and Regulatory Updates: \nThe primary endpoint of blood phenylalanine reduction in the APHENITY trial for sepiapterin in PKU was achieved, with highly statistically significant and clinically meaningful results.PTC expects to file an NDA for sepiapterin in the fourth quarter of 2023, pending FDA feedback.All key objectives were met in the 12-week interim data analysis of the PIVOT-HD trial of PTC518 in Huntington's disease patients.PTC expects to submit the BLA for Upstaza in the third quarter of 2023.PTC expects a CHMP opinion on the Type II variation to support the conversion of the conditional marketing authorization for Translarna to a standard marketing authorization in the third quarter of 2023.PTC expects additional regulatory meetings in the second half of 2023 including:Type C meeting with the FDA for vatiquinone in FAType C meeting with the FDA for Translarna in DMDSecond Quarter 2023 Financial Highlights:\nTotal revenues were $213.8 million for the second quarter of 2023, compared to $165.5 million for the second quarter of 2022.Total revenues include net product revenue across the commercial portfolio of $174.6 million for ...