2024-03-11 12:09:08 ET
Legend Biotech Corporation (LEGN)
Q4 2023 Earnings Conference
March 11, 2024 08:00 AM ET
Company Participants
Jessie Yeung - Head of Investor Relations and Public Relations
Ying Huang - Chief Executive Officer
Lori Macomber - Chief Financial Officer
Guowei Fang - Chief Scientific Officer and Head of Business Development
Steve Gavel - Senior Vice President, Commercial Development, US and Europe
Conference Call Participants
Jessica Fye - J.P. Morgan
Jonathan Miller - Evercore ISI
Ziyi Chen - Goldman Sachs
Dave Windley - Jefferies
Leonid Timashev - RBC Capital Markets
Vikram Purohit - Morgan Stanley
Kostas Biliouris - BMO Capital Markets
Ashwani Verma - UBS
Edward Tenthoff - Piper Sandler
Justin Zelin - BTIG
Mitchell Kapoor - H.C. Wainwright
George Farmer - Scotiabank
Gena Wang - Barclays
Kelsey Goodwin - Guggenheim
Presentation
Operator
Good day, and welcome to Legend Biotech Reports Fourth Quarter Earnings Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this call is being recorded.
I would now like to hand the call over to Jessie Yeung, Head of Investor Relations and Public Relations. You may begin.
Jessie Yeung
Good morning. This is Jessie Yeung, Head of Investor Relations and Public Relations at Legend Biotech. Thank you for joining our Conference Call today to review our Fourth Quarter and Full Year 2023 Performance.
Joining me on today's call are Ying Huang, the company's Chief Executive Officer; and Lori Macomber, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for a Q&A. We have Guowei Fang, Chief Scientific Officer; and Steve Gavel, Head of Commercial Development for the US and Europe, joining the Q&A session.
During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the Investors section of our company website. Thank you.
I will now turn the call over to Ying.
Ying Huang
Good morning, everyone. We're glad you could join us today because a lot has happened since our last earnings call. First, we're excited at the prospect of bringing our lead therapy CARVYKTI to more multiple myeloma patients in Europe. As many of you have heard, CARVYKTI received a positive opinion from the Committee for Medicinal Products for Human Use to expand into earlier lines of treatment. CARVYKTI is the first CAR-T therapy to receive a positive CHMP opinion in the second-line setting for patients with relapsed and lenalidomide-refractory multiple myeloma. The formal European Commission decision is expected in April.
As for the approval of CARVYKTI in the United States in the second-line, we are scheduled to meet with the FDA's oncologic drugs advisory committee this Friday, the 15th, to answer any outstanding questions they have. We are preparing for a potential launch in this expanded indication on the PDUFA date of April 5th, and we will, of course, keep you posted....
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Legend Biotech Corporation (LEGN) Q4 2023 Earnings Call Transcript