Iovance Biotherapeutics, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Iovance Therapeutics reported strong second quarter sales of AMTAGVI at $91 million, up from $60 million in the first quarter, driven by growing real-world evidence, increased physician awareness, and expansion of authorized treatment centers (ATCs) to nearly 100 in the U.S.
- The company expects to have about 110 authorized treatment centers by year-end, with approximately one-third in community settings, facilitating patient access.
- Proluken sales were $9 million in Q2, down from $11 million in Q1, with strong demand expected to continue in the second half of the year.
- Gross margin improved to 56% in Q2 from 41% in Q1, primarily due to in-house manufacturing efficiencies and volume growth; management targets a long-term margin goal of around 70%.
- The LU1202 Phase 2 registrational trial for second-line refractory non-small cell lung cancer is nearing completion, with updated data expected in Q4 2024 and a supplemental BLA submission planned for 2027.
- Interim lung cancer data showed a 26% response rate with duration of response not reached, indicating potential for durable benefit.
- The TALVANCE 301 Phase 3 trial in first-line melanoma is progressing well with accelerated enrollment and multiple data cuts planned.
- Additional pipeline programs include a Phase 2 registrational trial for soft tissue sarcoma (Saratoga) and biomarker-driven studies in endometrial cancer, with promising early results.
- Iovance is developing next-generation TIL therapies including 4001 (PD-1 inactivated) and 5001 (expressing tethered IL-12) to enhance efficacy and expand indications.
- Cash and equivalents totaled over $300 million at the end of Q2, providing runway into the second half of 2028.
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Transcript
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Okay. Great. Thanks everyone for being here. My name is Yanan Zhu, and I'm one of the biotech analysts here at Wells Fargo. It is my great pleasure to be joined by the management team of Iovance Biotherapeutics. With me here are Corleen Roche, CFO, and Brian Gastman, EVP Translational Medicine and Research. Thanks, Corleen and Brian, for joining us.
Thanks for having us. Our pleasure.
Great. I was wondering if the team can kick off with a brief overview of the company before we dive into questions.
Sure. Our company is based on a therapy called TIL therapy, which is essentially taking immune cells that the body deems the most important to fight against the tumor, but there is just not enough of them out of the patient. We manufacture those to the billions, and then we prep the patient ahead of time, give those same cells that came from the patient, that are actually unmodified, right back to the patient. This therapy style has been around for decades. There are patients who are alive with refractory melanoma over 30 years since their treatment. We are building on the shoulder of giants. We are also based on a registrational trial that completed its five-year study. It has been published and really unprecedented long-term outcomes for these patients.
Great, thank you. Let us talk about the commercial performance of AMTAGVI. Congrats on a very strong second quarter, where you had $91 million in sales compared to $60 million in the first quarter. That is a big jump. Can you remind us what drove the increase in sales?
Absolutely. I will probably boil it down to a few things. I would say, just to remind everyone, we have a growing body of real-world evidence, which is showing response rates over 50% in true second line. I think having that communication with the physicians, them having that data, is giving them even more confidence to treat and to treat earlier. We have done some surveys, and our physician awareness over the past year has grown threefold. We have also grown our network of authorized treatment centers, so we have breadth as well as depth, and we are continuing to do so. We have mentioned before we will have at least 110 authorized treatment centers by the end of the year.
Got it. I think at the earnings call, you did mention you have good visibility into the third quarter back then at the earnings call. Can you give us any update on the observation back then that demand continues to grow, the trends were still very positive? Any update to that statement, and how would you project sales for the third quarter?
Yep. I won't guide for the third quarter, but let me tell you this. We're continuing to see those positive demand trends. And they're happening as we sit here, which is actually really, really good news as they continue to grow. As far as our forecast, we have mentioned that we will update our full year guidance. That'll give you a view into the full second half, Q3 and Q4, and we'll do that within this quarter. We mentioned that at the call.
Before the next earnings call, you would update the guidance?
Yes. Okay, great. Any comment on the fourth quarter sales?
I don't know how much visibility you have, but when you make the guidance, how much confidence do you have for the fourth quarter?
I'll go back to an earlier comment. It's early days on the fourth quarter. We do have visibility because of the process. We are continuing to see positive demand trends. That's what I can tell you about the fourth quarter. And when we give that guidance, we'll have even a little bit more visibility, right? Not full, but we'll have a good sense of what's going on. But the positive demand trends are a good indicator.
Okay. I was wondering, in terms of quarter-over-quarter change, could we expect continued quarter-over-quarter growth for the rest of the year?
Yes, that's the goal. I believe you will see quarter-over-quarter growth. Now, I do have to give one caveat. The first quarter and second quarter had a little bit of timing offset, so that growth percentage might be a little bit inflated because of the timing of some maintenance we did in the first quarter, but you will definitely be seeing growth.
That's great to hear. Thank you. Let's talk about the ATC network. Could you provide an update on the number of centers currently offering AMTAGVI and your expectation for the network's expansion through the end of the year?
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