Revance Therapeutics, Inc. (NASDAQ:RVNC) Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET
Company Participants
Jessica Serra – Head-Investor Relations and ESG
Mark Foley – Chief Executive Officer
Dustin Sjuts – President
Toby Schilke – Chief Financial Officer
Conference Call Participants
Ken Cacciatore – Cowen and Co
Seamus Fernandez – Guggenheim
David Amsellem – Piper Sander
Annabel Samimy – Stifel
Balaji Prasad – Barclays
Vamil Divan – Mizuho Securities
Douglas Tsao – H.C. Wainwright
Rohit Bhasin – Needham
Operator
Welcome to the Revance Therapeutics’ First Quarter 2022 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, May 10, 2022.
I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.
Jessica Serra
Thank you, Nika. Joining us on the call today from Revance, are Chief Executive Officer, Mark Foley; President, Dustin Sjuts; and Chief Financial Officer, Toby Schilke.
During this conference call, management will make forward-looking statements, including statements related to the regulatory process and potentional approval and timing of approval of DaxibotulinumtoxinA for Injection in glabellar lines and a therapeutic indication, plans related to RHA Redensity and OPUL platform the benefits to us practices and patients of our products and services, our financial performance, 2022 guidance, expected cash runway, strategic priorities, and capital allocation plans, our market and revenue opportunity and the market demand for our products and services, portfolio growth and our business strategy, planned operations and commercialization plans.
With that I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?
Mark Foley
Thank you, Jessica. Good afternoon everyone, and thank you for joining our first quarter 2022 financial results conference call. We had a very productive start to the year delivering on several important objectives. First and most importantly, the FDA accepted our BLA resubmission for DaxibotulinumtoxinA for Injection for glabellar lines. With the acceptance, we received a new PDUFA date of September 8, 2022, which reflects a Class 2 resubmission and will include a reinspection of our manufacturing facility.
This important regulatory milestone was made possible by the completion of our new working cell bank qualification package in Q1. And I would like to thank the technical operations, clinical and regulatory teams for all of their hard work in achieving this objective. Having a PDUFA date is key. This will be the first time since our deferred action in November, 2020, that we are working towards a specific date. We will continue to work with the FDA to facilitate their timely review while recognizing that we are now one step closer to a potential approval later this year.