Legend Biotech Corporation (NASDAQ:LEGN) Q3 2023 Earnings Call Transcript

Ying Huang: Thank you, Kostas, for your questions. So on CARTITUDE-5, we’re very much on track to complete the ex-US enrollment of CARTITUDE-5 by end of this year. And now we’re looking at potentially over-enrolling CARTITUDE-5 in the US because as I mentioned previously in this call, we would like to have a very representative US patient population in the overall patient enrolled in CARTITUDE-5. So we’re going to probably extend the US enrollment by about one quarter into the first quarter of next year. But at this point, I can tell you that we’re very pleased with the enrollment status. Like I said, we’re pretty much down for the ex-US portion for CARTITUDE-5 by end of this year. So everything is going according to plan, but we do want to over-enroll in the US, given the demand from patients and also given the fact that we would like to have a higher percentage of US patients in this trial.

On CARTITUDE-6, we just started our first patient last month in Spain and it will probably take us about a couple of years while we enroll. So regarding to the production, we likely will utilize our Ghent facility that’s coming online next month to start production of CARTITUDE-6. We could also use additional capacity from our CDMO to satisfy that demand for CARTITUDE-6 production. That is our current plan now.

Operator: Thank you. One moment for our next question. And our next question coming from the line of Justin Zelin with BTIG. Your line is open.

Justin Zelin: Thanks for taking the questions and congrats on the strong quarter. So can you give us an update on the out-of-spec rate for CARVYKTI today? Just how things have been trending? And second, just on pipeline strategy, will you look to continue to seek partnerships for your pipeline assets in the future or could you internally develop them and bring them forward? Thank you.

Ying Huang: So, Justin, I’ll talk about the out-of-spec rate question. We’re very pleased where things have been trending in the last six months or so. Our out-of-spec rate has been decreasing and also stabilizing and it’s been consistently in the teens range and right now, it does stand below the 18% on-label out-of-spec rate, thanks to the very hard — very much hard work from the Legend team and J&J team in the New Jersey facility. We have really tried very hard to refine our manufacturing protocol by looking at various reasons for OS and also improving OS on various work streams. So that’s where we are. I don’t think we’re very much different from the competitions out-of-spec rate at this point. So I think, you know, we’re seeing a very encouraging trend. And like I mentioned, we do expect this to continue to go down, especially after FDA approves the second line indication. On the pipeline, the BD question, I’m going to refer that to our colleague, Guowei.

Guowei Fang: Yeah, thanks for the question. In terms of pipeline development strategy, we are open to both internal development, as well as seeking out the collaboration partnership. Our goal of pipeline development is to accelerate the development timeline and maximize the value for each individual asset so that we can bring differentiated and potentially transformative therapy to patients sooner. In this particular case, for LB2102, we see a unique synergy between ourselves and Novartis. We have a unique product design, a unique CAR construct sequence, and a unique armor mechanism to facilitate the immune cell infiltration and overcome the immune suppression in the tumor microenvironment. Whereas, Novartis has its unique manufacturing process, which is particularly important for a disease of small cell lung cancer.

As you know that disease progress very fast and faster manufacture process would add value to the product profile. So in this case, we see the synergy, and then in the future, we will continue to evaluate the asset by asset and try to find the synergy and realize the additional value where it’s possible. At the same time, if we have asset we can develop by ourselves, we will also do it in that way. Thank you.

Justin Zelin: Thanks for taking my questions.

Operator: Thank you. One moment for our next question. And our next question coming from the line of Mitchell Kapoor from H.C. Wainwright. Your line is open.

Mitchell Kapoor: Hi, everyone. Thanks for taking the questions. I just wanted to ask a little bit more about the supply constraints and if you could give kind of a quantitative sense of where we are in terms of meeting demand. I think at one point, there was a lot of supply exceeding demand in terms of, you know, I think there was about 15% being able to be met. Could you just talk about where we’re at today? And if you can’t, you know, give a quantitative number, could you just kind of help us understand the trend?

Ying Huang: Good morning, Mitch. Thanks for the question. And I’m going to answer this one. So, if you look at the reported revenue last quarter, which was $152 million and $140 million coming from the US, you sort of can guesstimate the number of patients we served in the commercial setting last quarter. I cannot give you exactly the percentage of demand we are satisfying, but I can tell you, starting from the beginning of the year, we always track our backlog in terms of patients waiting in the queue every month. And I can tell you from January until now, really, essentially, we’re seeing exactly pretty much the same number of patients in the backlog in the queue. So we’re not seeing any difference in terms of demand for this product at this point.

And we’re working very hard to ensure a robust and reliable supply. So we are going to continue to expand our supply. As you just heard from our colleagues on the call, we did receive the second FDA approval in the increase of our capacity recently. So we’re continuing to ramp up, given that approval, and then we’re planning additional increases in capacity from our New Jersey facility next year as well. If you look at the number of patients we think are within the so-called addressable market in the US, about 13,000 patients die every year, unfortunately, from multiple myeloma and probably around 8,000 to 9,000 patients are eligible for receiving CAR-T therapy. So at this point, given our supply, we think still we’re nowhere near being able to supply all the demand for our CARVYKTI at this point.