Orchard Therapeutics plc (NASDAQ:ORTX) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET

Company Participants

Bobby Gaspar - Chief Executive Officer

Frank Thomas - President and COO

Braden Parker - Chief Commercial Officer

Conference Call Participants

Robert Finke - Guggenheim Securities

Pete Stavropoulos - Cantor Fitzgerald

Brendan Smith - TD Cowen

Operator

Good day and thank you for standing by. Welcome to the Orchard Therapeutic Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only-mode. [Operator instructions]. Again, please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today. Bobby Gaspar, CEO and Co-founder.

Bobby Gaspar

Hello, everyone. I'm Bobby Gaspar, CEO and Co-founder of Orchard Therapeutics. Welcome to our second quarter 2023 conference call. We're especially delighted to share with you some important regulatory and business updates, as well as provide our quarterly financial results. Before we get started, I want to remind everyone that throughout this call, we will be making forward-looking statements. Please refer to the supplemental presentation materials and our latest SEC filings for more information.

As we'll highlight on today's call, Orchard continues to successfully execute across all aspects of our business, including commercial, regulatory, [ph]R&D, as well as operational management. The news we announced this morning reinforces Orchard's leadership position in the HSC gene therapy field. I have two members of the leadership team joining me on today's call. Following my remarks, Frank Thomas, President and Chief Operating Officer, will provide a summary of our momentum in Europe, as well as an overview of our financial results for the quarter. Braden Parker, our Chief Commercial Officer, will also be joining for Q&A.

We will keep our prepared remarks focused on three primary topics. First, you'll hear about the continued progress we are making to advance OTL-200 towards a potential U.S approval.

Second, we'll share updates regarding the commercial momentum we are building in Europe. And third, we'll provide a general business update and outline our quarterly financial results. Let's start with an update on the regulatory status of OTL-200 in the U.S.,which is intended for the treatment of early onset Metachromatic Leukodystrophy, or MLD. In the most severe form of MLD, babies develop normally, in late infancies start to rapidly lose the ability to walk, talk and interact with the world around them. These children may require 24 hours care, and the majority pass away within five years of disease onset, creating an enormous burden on patients, their families and healthcare systems. The medical need is significant, and we are seeing the value of our gene therapy for MLD being recognized by peers throughout Europe, where it has been approved since late 2020.