Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2023 Earnings Call Transcript

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Reni Benjamin: Thanks for taking the questions.

Operator: Our next question comes from Andrea Tan with Goldman Sachs. Your line is open.

Andrea Tan: Good afternoon. Thanks for taking our question. Friedrich, maybe a follow-up to the last question there, but I just wanted to confirm if you could share any more details on the basis of the partial clinical hold if it was any different from your initial thoughts back in December, that would be helpful? Thank you.

Friedrich Finckenstein: No. There’s nothing — there’s no information or no new aspects that we would have learned in the meantime from our interactions with the FDA. So, the basis, we discussed in quite a bit of detail in December, we’ve been working on addressing that. And as we said, we have addressed and are expecting a response about the enrollment of new patients. Again, just as a reminder, this was a partial hold, right? So, we are in agreement with the FDA to be able to offer the therapy to patients who were already enrolled and who had available products. So, that also hasn’t changed. So, again, no new information, no — nothing unexpected or new that we didn’t know back then.

Operator: One moment for our next question. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Kelsey Goodwin: Hey, good afternoon. Thank you for taking my question. I guess just to build a bit on some prior questions. First, for the.

Fred Vogt: Your voice is breaking, Kelsey.

Kelsey Goodwin: Okay. Can you hear me better now?

Fred Vogt: Operator, we’re unable to hear Kelsey’s question.

Operator: One moment. We’ll move on to the next question and come back to Kelsey one moment. Can you guys still hear me?

Fred Vogt: Yes. Operator, we can hear you. We’re just having a difficult time hearing the analysts.

Operator: Our next question comes from Ben Burnett with Stifel. Your line is open.

Ben Burnett: Great. Thank you very much. I just had just a question to help with the model. Can you talk about the price of Proleukin and just how much incremental revenue per patient this will be? And I guess as sort of a follow-up to that, is this handled the same regardless of if it’s — if the patient has commercial insurance versus government insurance?

Fred Vogt: Could you repeat the question, please? The first part of the question was cut off?

Ben Burnett: Apologies. I wanted to ask about Proleukin and how much incremental revenue per patient you might expect on top of the Amtagvi price tag? And then sort of the follow-up to that was, would that be handled the same, regardless of commercial insurance is involved versus government insurance?

Fred Vogt: Sure. Why don’t I take the first part and then Jean-Marc, you can jump in. So as you know, for the Amtagvi regimen Proleukin would be used six doses on average, 18 vials per dose at a whack of 5,551. What I would share is that the cost would be the same. The reimbursement would be the same, whether you are a commercial or government at this point with the exception of mandatory discounts for government sectors.

Ben Burnett: I see. Okay. That’s helpful. Thank you. And just maybe one question for Jean-Marc. To what extent does the cash runway assumption that you mentioned earlier, incorporate a revenue estimate for Amtagvi?

Raj Puri: Hello, Jean-Marc, are you there? Could you repeat that question one more time, Ben?

Ben Burnett: Certainly. I was just curious, to what extent is the cash runway assumption that was mentioned earlier in the prepared remarks, I guess, incorporated revenue estimate for Amtagvi. I’m curious if you could maybe speak to that estimate.

Jean-Marc Bellemin: Can you hear me now?

Raj Puri: Yes, we can hear you now.

Jean-Marc Bellemin: Okay. Sorry, we’re having some technical difficulties there. So thank you for the question, Ben. So yes, we do have take into account some revenue from Amtagvi and Proleukin into our cash runway. But, of course, obviously, we have been very conservative in the way we have taken those revenues. I’m not disclosing more. But again, conservatively on the revenue side, we have enough cash well into the second half of 2025.

Ben Burnett: Understand. Thanks so much.

Operator: Ladies and gentlemen, this does conclude today’s presentation. I would now like to turn the call back over to Fred for any closing remarks.

Fred Vogt: And operator, can you confirm that you can hear me just because of the technical difficulties.

Operator: Yes, I can hear you.

Fred Vogt: Thank you again for joining the Iovance Biotherapeutics fourth quarter and full year 2020 financial results and corporate update conference call. 2024 is already off to an incredible start for Iovance. Our mission is to remain the global leader in innovating, developing and delivering health therapies, and we have now planned a firm stake in the ground as the pioneers of the first commercial TIL therapy. It’s also a momentous occasion for the oncology community that has been advancing research, cell therapy for solid tumors for decades. We’re thankful to all the scientists, researchers, healthcare providers and institutions who have contributed to the field, to the patients and their loved ones who have participated in TIL therapy clinical trials.

It takes a large and coordinated effort to deliver this type of first-in-class category therapy to patients, and this achievement is a testament to the unwavering commitment expertise and collaborative efforts of many. Thank you to those in the healthcare advocacy and patient communities, as well as the regulators, our partners and the local communities in Philadelphia, San Carlos and Tampa that made this US approval possible. I would also like to thank our shareholders and covering analysts for their support; and lastly, I want to thank our exceptional Iovance team, we could not be here without their cross-functional efforts and our collective steadfast commitment to following the science. We look forward to providing further updates on the Amtagvi launch and our pipeline on the first quarter 2024 conference call in May.

Please feel free to reach out to our Investor Relations team for a follow-up and apologies for the technical difficulties today. Thank you.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

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