Orchard Therapeutics plc (NASDAQ:ORTX) Q4 2022 Earnings Conference Call March 6, 2023 8:00 AM ET

Company Participants

Bobby Gaspar - Chief Executive Officer

Frank Thomas - President and COO

Braden Parker - Chief Commercial Officer

Leslie Meltzer - Chief Medical Officer

Conference Call Participants

Dae Gon Ha - Stifel

Hartaj Singh - Oppenheimer

Brendan Smith - TD Cowen

David Hoang - SMBC Nikko Securities

Robert Finke - Guggenheim Securities

Pete Stavropoulos - Cantor Fitzgerald

Bobby Gaspar

Hello, everyone. I'm Bobby Gaspar, CEO and Co-Founder of Orchard. I'm especially delighted to host our fourth quarter 2022 conference call, where we have a number of important corporate and regulatory updates, along with providing our full financial results. Before we get started, I want to remind everyone that this presentation contains forward-looking statements. Please refer to this slide and our latest SEC filings for more information.

I believe in news we announced this morning and that we will discuss during this call constitute a breakthrough moment in the evolution of our company and our HSC gene therapy platform. I have three members of the leadership team joining me on today's call. Following my remarks, Frank Thomas, President and Chief Operating Officer, will provide more view on the financing we announced this morning, along with a summary of our financial results for the quarter; Braden Parker, our Chief Commercial Officer; and Leslie Meltzer, our Chief Medical Officer, will also be joining for Q&A.

Our plan is to keep our prepared remarks focused on 3 primary topics during this call. First, to provide you an update on Libmeldy commercialization in Europe. Second, we will cover recent significant developments in the U.S. with our interactions with the FDA. And third, to review the financing that we announced this morning that will take the need for additional capital off the table for the foreseeable future.

Let's start with Libmeldy. We've always believed HSC gene therapy will be the future for treating certain severe neurometabolic disorders. And with the approval and launch of Libmeldy in Europe, we are making that future a reality for patients with MLD. Our commercial and medical teams continue to identify, refer and support treatment of eligible MLD patients and we are seeing signs that disease awareness is growing among the physicians diagnosing and managing patients. In fact, we expect will be reflected in our annual revenue figures for 2023.

Libmeldy generated just under $20 million in sales in 2022 during its first year of launch, and that was only with a few reimbursement agreements in place. As we expand access and reimbursement to other markets in Europe and see the implementation of additional newborn screening studies, we are optimistic that sales will continue to grow in 2023 in Europe, while we also prepare for a potential 2024 launch in the U.S.