-Hepatitis C: FDA decision on NDA for INCIVEK TM (telaprevir) expected this month- -Cystic Fibrosis: Phase 3 program for VX-770 supports applications for approval in U.S. and E.U., with NDA and MAA planned for second half of 2011- -Financial: Vertex enters second quarter with more than $820 million
-Approximately 600 people with cystic fibrosis have started treatment with KALYDECO since approval on January 31 - -Multiple ongoing clinical trials to generate data beginning in second quarter, including study of KALYDECO combined with VX-809 in cystic fibrosis and first data for Alios nucleotides
-First quarter 2013 total revenues of $328 million , including net product revenues of $206 million for INCIVEK in hepatitis C and $62 million for KALYDECO in cystic fibrosis- -Cystic fibrosis: Enrollment ongoing in Phase 3 program for VX-809 in combination with ivacaftor for people with two copies
-Net product revenues of $100 million for KALYDECO in cystic fibrosis- -Cash, cash equivalents and marketable securities of $1.32 billion on March 31, 2014 - -Six-month dosing period complete for Phase 3 TRAFFIC and TRANSPORT studies of lumacaftor in combination with ivacaftor for people with CF
-First quarter 2015 total revenues of $139 million , including net product revenues of $130 million for KALYDECO ® (ivacaftor) in cystic fibrosis- -Cash, cash equivalents and marketable securities of approximately $1.2 billion on March 31, 2015 - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
-First quarter 2016 cystic fibrosis product revenues of $394 million ; $223 million for ORKAMBI ® (lumacaftor/ivacaftor) and $171 million for KALYDECO ® (ivacaftor)- -Provides 2016 guidance for ORKAMBI product revenues of $1.0 to $1.1 billion ; increases 2016 guidance for KALYDECO product revenues
— Product revenues of $2.10 billion , a 22% increase compared to Q1 2021 — — Company reiterates full year 2022 product revenue guidance of $8.4 to $8.6 billion — — Mid- and late-stage clinical pipeline now spans 6 disease areas — BOSTON --(BUSINESS WIRE)--May 5, 2022-- Vertex Pharmaceuticals
— Product revenue of $2.37 billion , a 13% increase compared to Q1 2022 — — Company reiterates full year 2023 financial guidance, including product revenue guidance of $9.55 to $9.7 billion — — TRIKAFTA approved in U.S. for children with cystic fibrosis 2 to 5 years of age — — Pipeline advancement
-First-quarter 2017 cystic fibrosis product revenues of $481 million ; $295 million for ORKAMBI and $186 million for KALYDECO- -Company reiterates 2017 guidance for ORKAMBI product revenues of $1.1 to $1.3 billion and increases 2017 guidance for KALYDECO product revenues to $710 to $730 million -
-First-quarter 2018 total CF product revenues of $638 million , a 33% increase compared to $481 million in the first quarter of 2017- -Company reiterates full-year 2018 total CF product revenue guidance of $2.65 to $2.80 billion and combined non-GAAP R&D and SG&A expense guidance of $1.50 to $1.55
