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EX - 99.1 2 ptct - 20211028ex9914df365.htm EX - 99.1 PTC / THERAPEUTICS TM PTC Therapeutics Provides a Corporate Update and Reports Third Quarter 2021 Financial Results EXHIBIT 99.1 - Total quarterly revenue of $ 139 million ; 17 % increase over third quarter 2020 - Raises 2021 DMD franchise revenue guidance to $ 400- $ 420M from $ 370- $ 390M - - Continues to advance robust clinical pipeline by initiating a fifth registration - directed trial , APHENITY Phase 3 trial of PTC923 in phenylketonuria ( PKU ) – - Brazil achievements include Category 1 pricing for Tegsedi® , regulatory approval of Waylivra ™ and expansion of the Translarna TM label to include patients as young as 2 years of age - SOUTH PLAINFIELD , N.J. , Oct 28 , 2021 PTC Therapeutics , Inc. ( NASDAQ : PTCT ) today announced a corporate update and financial results for the third quarter ending September 30 , 2021 . " The stellar growth of our DMD franchise is remarkable . " said Stuart W. Peltz , Ph.D. , Chief Executive Officer , PTC Therapeutics , Inc. " I continue to be impressed by the team's performance . The commercial performance , along with the milestones achieved in Brazil , and the continued advancements in our pipeline , with initiating a fifth registration - directed trial , allows us continued value creation for all of our stakeholders . " ● Key Third Quarter and Other Corporate Updates : The Duchenne muscular dystrophy ( DMD ) franchise grew 39 % over the third quarter of 2020 , demonstrating PTC's continued strong commercial performance . Quarterly net product revenue for the franchise was $ 114 million in the third quarter of 2021 . O Translarna ™ M ( ataluren ) revenue growth was driven by geographic expansion and new patient identification . O Emflaza® ( deflazacort ) revenue growth was driven primarily by new patient starts and maintained high compliance . Evrysdi TM ( risdiplam ) continues to show strong global uptake . The first commercial sale of Evrysdi ™ in Japan occurred in August 2021 , resulting in a $ 10 million milestone payment from Roche to PTC with $ 325 million in sales - based milestones remaining . EvrysdiTM is a product of a collaboration between PTC , Roche and the SMA Foundation . ● Waylivra ™ ( volanesorsen ) was approved by the Brazilian Health Regulatory Agency , ANVISA ( Agência Nacional de Vigilância Sanitária ) , as the first treatment for familial chylomicronemia syndrome ( FCS ) in Brazil . Tegsedi® ( inotersen ) has successfully received Category 1 classification from CMED ( Drug Market Regulation Chamber ) in Brazil . Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care and allows for pricing in line with international markets .