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

Ying Huang: Thanks Kelly. So we’re very pleased to announce that the first patient has been enrolled last month in Spain. So we officially have kicked off the initiation of CARTITUDE-6 and we are going to initiate the enrollment in the US also very soon. At this point, I can tell you that we will promise to enroll a certain percentage of US-based patients because we have to submit the data to the agency later to make sure that we have a representative US patient population in the overall patient. Although probably the majority of the patients will be enrolled ex-US for CARTITUDE-6.

Kelly Shi: Thank you very much.

Operator: Thank you. And our next question coming from the line of Vikram Purohit from Morgan Stanley. Your line is open.

Vikram Purohit: Hi. Good morning. Thank you for taking our questions. This is Vikram. We have two. First, assuming you were to obtain approval for CARVYKTI for the expanded label based on the CARTITUDE-4 data by next April. Could you just walk us through your latest thinking on what you expect the ramp to look like in earlier line use in 2024 onwards? And then secondly, back to the topic of competition. So Bristol Myers and 2seventy have mentioned that they’re making a bigger commercial push for Abecma that includes site expansion to broaden out access for the therapy. I wanted to see if you’ve noticed any competitive impact at this point from those efforts and if you and J&J feel the need to increase your marketing and promotional spend behind CARVYKTI in response to the efforts from Bristol Myers and 2seventy. Thanks.

Steve Gavel: Yeah. Hi. It’s Steve. So let me try to take them. I think the second part of your question had to do with site expansion, also promotional spend. We’ll continue to expand sites over time. We’ll exit this year we think right around 70 sites and we’ll see — our site expansion is predicated on delivering and our manufacturing capacity increasing. So we are targeting by the end of next year to be exiting at about between 90 to 100. So that hopefully answers your question around site expansion. And as I remember just, as I continue to state there, this is more than just site expansion. All these sites are not created equal in terms of the numbers of patients that they treat. Our philosophy is continue to increase our site expansion to ensure that we can accommodate the demand within those sites. I think your second question had to do with CARTITUDE-4. Can somebody help me here?

Lori Macomber: The ramp.

Steve Gavel: The ramp. Yeah. So thanks. So how we’re planning the CARTITUDE-4 ramp in terms of the forecast perspective, we were initially, and we continue to assume a very quick ramp up, especially in the high-risk population in second line plus. In some of the research that we fielded post-ASCO, once we released the CARTITUDE-4 data, we’re also seeing high demand also in the standard risk population. So generally speaking, again, we’re very excited, as you can imagine, in launching CARTITUDE-4 for our patients, but we see it much broader than we were initially thinking beyond the higher-risk group.

Vikram Purohit: Got it. Thank you.

Operator: Thank you. One moment for our next question. And our next question coming from the line of Leonid Timashev from RBC Capital Markets. Your line is open.

Leonid Timashev: Hi, guys. Thanks for taking my question and congrats on the quarter. I wanted to stick with the competition discussion for just a little bit. We’ve been hearing that there’s actually been capacity constraints in the CAR-T space as a whole with actually BCMA and CD19-directed CAR-Ts competing for beds and infusion capacity. I guess, is this something that you’re seeing as you’re continuing to launch CARVYKTI? And do you expect these dynamics to lift or continue? Thanks.

Steve Gavel: Yeah. Hi. It’s Steve. I’ll take that again. I think that’s a very, very good point. So that’s why it’s so important. This is why you’re seeing a large percentage now of sites moving to hospital outpatient for cilta-cel. So yes. So to your point, it’s a very valid point that you cannot continue to treat CAR-T therapies as just a single inpatient modality. We knew that leading into launch and it was the reason why we were continuing to monitor how the market was moving to outpatient to increase capacity to your point. So you address capacity, in two, in essence two ways, right? So you continue to monitor to see how the market’s moving in the outpatient setting. And as I stated earlier, we’re running at about 3 out of 10 patients now being treated that way, and we see that continuing to grow significantly over time.

So that’s the first piece of that, of solving that issue. And then the second way you resolve that is by increasing sites themselves. And we’ll continue to do that as well. So it’s a combination of a number of different moving parts. So we’ll see how the market is moving in the outpatient setting, and then we’ll also continue to add more and more sites to accommodate. To your point, the patient volume to ensure that we have enough or the sites have enough volume to pull through the volume of patients for our indication.

Ying Huang: And Leonid, this is Ying. Maybe I want to add that, you know, if you look at the number of transplants that are performed in a setting of myeloma, it’s about 9,000 transplants that’s performed every year in the United States market. So we think at this point, at least for multiple myeloma, we’re not approaching that limit in terms of hospital beds yet. As you know, if you look at our supply into the market, right, we’re nowhere near that 9,000 number yet. Thank you.

Operator: Thank you. One moment please for our next question. And our next question coming from the line of Yaron Werber with TD Cowen. Your line is open.