Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) Q3 2023 Earnings Call Transcript November 6, 2023 4:30 PM ET

Company Participants

Susie Lisa - CFA, Senior Vice President of Investor Relations

Reshma Kewalramani - President & Chief Executive Officer

Stuart Arbuckle - Executive Vice President & Chief Operating Officer

Charlie Wagner - Executive Vice President & Chief Financial Officer

Conference Call Participants

Geoff Meacham - Bank of America

Robyn Karnauskas - Truist Securities

Salveen Richter - Goldman Sachs

Phil Nadeau - TD Cowen

Mohit Bansal - Wells Fargo

Jessica Fye - JPMorgan

David Risinger - Leerink Partners

Evan Seigerman - BMO Capital Markets

Liisa Bayko - Evercore ISI

Michael Yee - Jefferies

Terence Flynn - Morgan Stanley

Operator

Good day and welcome to the Vertex Pharmaceuticals Third Quarter 2023 Conference Call. All participants will be in a listen only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded.

I would now like to turn the conference over to Ms. Susie Lisa. Please go ahead, ma'am.

Susie Lisa

Good evening all. My name is Susie Lisa, and as the Senior Vice President of Investor Relations, it is my pleasure to welcome you to our third quarter 2023 financial results conference call. On tonight's call, making prepared remarks, we have Dr. Reshma Kewalramani, Vertex's CEO and President; Stuart Arbuckle, Chief Operating Officer, and Charlie Wagner, Chief Financial Officer. We recommend that you access the webcast slides as you listen to this call. The call is being recorded and a replay will be available on our website.

We will make forward-looking statements on this call that are subjects to the risks and uncertainties discussed in detail in today's press release and in our filings with the Securities and Exchange Commission. These statements, including without limitation, those regarding Vertex's marketed cystic fibrosis medicines, our pipeline, and Vertex's future financial performance are based on management's current assumptions. Actual outcomes and events could differ materially. I would also note that select financial results and guidance that we will review on the call this evening are presented on a non-GAAP basis. In addition, the impact of foreign exchange is presented inclusive of our foreign exchange risk management program.

I'll now turn the call over to Reshma.

Reshma Kewalramani

Thanks, Susie. Good evening all, and thank you for joining us on the call today. We've delivered another strong quarter and continue to drive execution across the company. By reaching more CF patients, third quarter global product revenue grew 6% versus the prior year period and we are raising full year 2023 CF product revenue guidance to approximately $9.85 billion. We are delivering on our marketed medicines in CF, while simultaneously preparing for commercial excellence in multiple areas ahead of our potential near-term launches, including exa-cel in both severe sickle cell disease and transfusion dependent beta thalassemia, VX-548 for acute pain and longer term in peripheral neuropathic pain, and our vanzacaftor triple combination therapy for cystic fibrosis. Most notably, we are tracking towards an exa-cel PDUFA date for sickle cell disease on December 8th of this year and for TDT on March 30th of next year, with global regulatory reviews also underway in Europe and the UK. Phase 3 pivotal trial readouts in early 2024 from both our vanzacaftor triple NCF and our VX-548 program in acute pain, a Phase 2 trial readout by year end 2023 from our VX-548 trial in diabetic peripheral neuropathy, and completion of enrollment in the Phase 2 portion of the VX-147 Phase 2/3 program in AMKD later this year.