Yahoo Finance Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q4 2023 Earnings Call Transcript
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q4 2023 Earnings Call Transcript March 6, 2024
Adaptimmune Therapeutics plc isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Hello and welcome to Adaptimmune's Fourth Quarter and Year-End Conference Call and Business Update. I will now turn the call over to Juli Miller. Juli, please go ahead.
Juli Miller: Good morning, thank you for joining us. Welcome to our Q4 and full-year 2023 update and I refer you to our disclaimer here, as well as our forward-looking statements in this morning's press release. For the prepared portion of the call, Adrian Rawcliffe, our CEO, is with us, and other members of our management team are available for Q&A. With that, I'll turn the call over to Adrian. Ad?
Adrian Rawcliffe: Thanks Julie. Thanks everyone for joining today. So I planned today to recap the progress we made in 2023 and share a little bit about our plans for 2024. I'll be focused primarily on a Afamicel, which will be our first commercial product in our sarcoma franchise. 2023 was a year of transformation for Adaptimmune. We completed a corporate restructuring and a merger with TCR Squared. And following that, we undertook a clinical pipeline review focusing on the highest priority and value assets. We recovered Letecel and PRAME from GSK. I want to remind you that Letecel came with a fully enrolled pivotal trial that has already met its primary endpoint for efficacy at the interim analysis, which was disclosed late last year.
We also submitted the BLA for a Afamicel. This is a significant milestone for adapting, you know, obviously, but it's also a significant milestone for the sector as the first ever BLA for an engineered cell therapy for a solid tumor indication. As well as the submission, we took the opportunity working with the RMAT designation to understand the FDA's requirements on a number of areas and de-risk that file and also sought the FDA's agreement on the opportunity for the second cohort of that SPEARHEAD-1 trial to provide the confirmatory evidence for full approval. Afamicel is the first product in our sarcoma franchise, a franchise that we estimate has PTO sales of up to $400 million. And as such, it's a beachhead for innovative cell therapy products in the solid tumor space.
It's the first product of our wholly-owned pipeline of cell therapy products with the most significant of those in clinical development being a product that was previously known as ADPA2M4CD8, but has now been granted the user name of uzatresgene autoleucel or uzacel. Uzacel has been developed in ovarian, bladder and head and neck cancer, and all of this is enabled by our long-term investment in the capabilities needed to be a cell therapy company. That means that at this point, we have the opportunity to transition into a fully integrated commercial stage company, discovering, developing, and now importantly delivering cell therapy products to patients. I want to touch a bit on our launch preparedness. As a Afamicel is currently undergoing its priority review at the FDA.
We've been informed that the FDA does not currently anticipate an adcom for Afamicel, but we are clearly on the FDA's clock now. Everything is proceeding as you would anticipate for a product with priority review and a PDUFA date in August. Afamicel is a highly anticipated product and we intend to be in the position to commercialize Afamicel on approval in August. To that end, I'm delighted to welcome back Cintia Piccina as our Chief Commercial Officer. She will lead our commercial efforts for Afamacel, in due course for Letecel, and the rest of the pipeline that I talked about. We are in the final stages of recruiting the commercial team, with the majority of that headcount secured and the remaining few roles will be in place by the middle of the second quarter.
Same goes for the medical affairs team with the majority of that team recruited and the remaining members of that team due to join us over the next few weeks. We've also bolstered the manufacturing team and we'll be scaling that up to meet the commercial demand for Afamicel. I want to put -- remind everybody that we have manufacturer Afamicel in-house at the Navy Yard facility in Philadelphia. We believe this is a key differentiator giving us not only control and the ability to scale demand according to our needs, but also the opportunity to produce Afamicel at a margin that will be very attractive, and we've referred previously to a 70% margin for our sarcoma franchise at peak year sales. As you see from this slide, we have a clear plan to stand up the necessary infrastructure and we're on track to do so for that launch, including a sponsored testing plan for the major four diagnostic and the patient support infrastructure necessary to help patients and the providers navigate through treating patients with Afamicel.
Subject to FDA's approval around that PDUFA date we anticipate actually infusing our first patients with Afamicel in Q4 2024. We will be updating as we go through this process to register and launch Afamicel. And I want to tell everybody that the first such update will occur on our Investor Day on Thursday, the 18th of April. There we will discuss not only our plans and preparation for the commercial of the first engineered T-cell for solid tumor, but also we -- how we see the opportunity in advanced sarcomas, the paucity of existing treatment options, and the opportunity to hear from patient advisory groups and providers about the opportunity represented by Afamicel for these patients. With Afamicel BLA filed and awaiting approval, we're executing on our plans for our sarcoma franchise.
As I referred to earlier, Letecel has now been recovered from GSK. The pivotal trial has finished enrollment. The primary endpoint for efficacy has been met, and it's now clear that Letecel is a product in its own right and has the opportunity to go through exactly the same commercial channels that we'll be developing for Afamicel, resulting in substantial synergies for these overlapping patient populations. We have the opportunity to reach $400 million in peak sales with these cell therapies with an addressable patient population a little north of a thousand patients per year with synovial sarcoma and MRCLS. I just want to make the point that, that is in the United States in the launch indications that we anticipate only. We're proud of the progress that we made in 2023.
We view this as securing our place on the starting line to make cell therapy products available for people with solid tumors, beginning with our sarcoma franchise. This gives us the immediate opportunity to create near-term commercial value in 2024 and 2025, and set the company up for long-term success with our wholly-owned pipeline of cell therapy products. And with that, I'll turn over to the operator for Q&A. Operator?
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