Replimune Group, Inc. (REPL) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the TUDRIQEV FDA Accelerated Approval Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Arleen Goldenberg, Vice President, Corporate Communications. Please go ahead.

Thank you, operator. Welcome, and thank you all for joining us on this exciting day to discuss the FDA Accelerated Approval of TUDRIQEV. I'm Arleen Goldenberg, and I'm joined on the call today by Sushil Patel, our Chief Executive Officer; Kostas Xynos, our Chief Medical Officer; and Emily Hill, our Chief Financial Officer. A short time ago, we issued a press release announcing the FDA accelerated approval of TUDRIQEV. The press release and the slide presentation to accompany today's call are available in the Investor Relations section of our website at replimune.com. Before we begin, I'd like to remind you that any statements made during this call that are not historical are considered to be forward-looking statements. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the Risk Factors section in the company's most recent quarterly report on Form 10-Q as well as other reports filed with the SEC. Any forward-looking statements may represent our views as of today, August 6, 2026, only. A replay of the call will be available on the company's website following its completion. On today's call, we will discuss the U.S. Food and Drug Administration's accelerated approval of TUDRIQEV, including plans for commercial launch. Following our prepared remarks, we will open the call for your questions. And with that, I am pleased to turn the call over to Sushil Patel, Chief Executive Officer of Replimune, who will take us from Slide 3.

Thank you for joining us today to discuss the FDA accelerated approval of TUDRIQEV, formerly known as RP1. This is a key milestone for Replimune and an even more important moment for advanced melanoma patients who are in desperate need of new treatment options. I want to take a moment to acknowledge the hard work and dedication of the entire Replimune team in getting us to this pivotal stage in our mission. The focus of today's call will be to review highlights of our broad label, reflective of the real-world population we enrolled in the IGNYTE trial. In addition to the label, we will also discuss the launch strategy and key activities that we believe will enable successful commercialization. We have always operated with a focus on patients and today marks an important step in the journey to help as many of them as possible. Patients like Erin, whose treatment had failed to respond to initial immunotherapy for advanced melanoma. Erin received TUDRIQEV in combination with nivolumab as part of the IGNYTE clinical trial, and she has no evidence of disease since completing the treatment, which has allowed her to continue to enjoy life with her friends and family. We are incredibly grateful to the patients, families and clinicians who participated in our clinical trials as well as the many others, including leading melanoma experts from around the globe as well as advocacy groups who have supported our work over the past year. Today would not be possible without you. Slide 5. Replimune was founded to develop the next generation of oncolytic immunotherapies. To date, the RPx platform has been tested in approximately 1,000 patients, and we have now reached a major milestone with our first FDA approval. This marks an important moment and opportunity to potentially help thousands living with advanced melanoma. Today, we are proud to announce that the FDA has approved TUDRIQEV in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma that progressed on a PD-1 antibody-based regimen. Slide 5 -- Slide 7, sorry. We are pleased that our label reflects a broad population of advanced melanoma patients, inclusive of all subgroups studied in our trial. The label describes the meaningful clinical effect in non-injected lesions, the ability to treat superficial, deep and visceral lesions and has no requirement for prior BRAF treatment. The label also allows for the retreatment of those who are benefiting from therapy after their initial 8 doses. With that, I will turn over to Kostas Xynos, our Chief Medical Officer, who will review some of the more specifics of the U.S. prescribing information.

Thank you, Sushil. Please advance to Slide 9. Good afternoon. My name is Kostas Xynos, and I'm thrilled to be here today. I will share with you the main points of our U.S. label. I would like to start with a brief overview of the IGNYTE study, our global multicenter trial that formed the basis of TUDRIQEV's accelerated approval. IGNYTE was designed to evaluate RP1 in combination with nivolumab in patients with advanced melanoma using rigorous criteria for PD-1 failure as patients had to progress while on treatment. This is an important distinction as it represents patients with true resistance to checkpoint inhibition, where existing treatment options are limited. In addition, patients without confirmed disease progression were able to continue or reinitiate treatment with RP1 if it was clinically indicated by the treating physician. This feature reflects how patients are managed in real-world practice and allows the treating physicians the flexibility to tailor the therapy based on the ongoing clinical benefit. Next slide, please. The patients enrolled in IGNYTE were representative of a real-world hard-to-treat advanced melanoma population, reflecting what clinicians usually see in their practice. The study included challenging to treat subgroups such as patients with Stage IV disease, those with prior adjuvant treatment, PD-1 neg -- PD-L1 negative patients and those with lung and liver lesions. Nearly half of the patients had lung lesions and 1/4 of them had liver lesions. Important note is that we observed no overall difference in safety or effectiveness in elderly patients who often represent a significant portion of the advanced melanoma population. Next slide, please. Moving on to the core efficacy data and starting with our primary endpoint, the label reflects the efficacy analysis of 91 patients with non-injected lesion response. TUDRIQEV plus nivolumab achieved an objective response rate of 24.2%. The median duration of response was 14.1 months with 55% of the patients remaining in response for 12 months or longer. The clinical results from the IGNYTE trial are further detailed in the primary publication in the Journal of Clinical Oncology. Overall, this data demonstrate that TUDRIQEV delivers deep, durable and clinically meaningful responses that support its long-term value in this disease setting. Next slide, please. TUDRIQEV is an off-the-shelf treatment practically for everyday clinical practice that minimizes logistical complexity and treatment delays and ensures that patients with aggressive disease receive immediate care. Dosing and administration is designed to be simple and flexible for health care professionals with a dose calculated as 1 milliliter per centimeter of tumor diameter with up to maximum of 10 milliliters injected. Clinicians will have versatility when choosing which lesion to inject, including both superficial and visceral lesions. Our guidance is to prioritize the most rapidly growing or largest lesions, whether new or existing, provided they are suitable for injection. Importantly, in terms of scheduling, TUDRIQEV does not need to be given the same day as nivolumab. Next slide, please. Here, I want to briefly show you how intuitively our therapy is administered. TUDRIQEV is injected directly into the tumor. All images are included in the USPI guiding injections. This slide illustrates the injection techniques for superficial tumors and demonstrate the straightforward and versatile administration techniques for TUDRIQEV, making it easy for health care providers to deliver the drug effectively to both superficial non-ulcerated as well as ulcerated tumors. These are standard and well-understood injection techniques, both in dermatology and oncology, requiring minimal specialized training and can be performed by all HCPs, including physicians, physician assistants, nurse practitioners and registered nurses. Next slide, please. These images address how our therapy is delivered to deep or visceral tumors, which are often the site of more advanced disease in organs such as the lung, the liver, the kidney or deep lymph nodes. Interventional radiologists are very familiar with these injections as they routinely perform them. These injections can be considered simpler than a biopsy as a much thinner needle is used. These injections are performed under image guidance, typically ultrasound for more accessible organs like the liver or CT scan for deeper lesions like the lung, assuring accurate placement and maximize safety. For IRs, this is their everyday life as these are routine procedures, common daily practice for them. Next slide, please. TUDRIQEV combined with nivolumab is a generally well-tolerated regimen with no reported contraindications. The most common adverse reactions were generally mild to moderate, consistent with previously reported data and were predominantly grade 1 and 2 constitutional type side effects. Importantly, there were no grade 4 or 5 common adverse events. On the right-hand side of the slide, you can see some additional safety highlights. A critical safety finding is that there has been no reported transmission to close contacts. Furthermore, TUDRIQEV can be managed as biosafety level 1, which is the lowest possible biosafety level and can be effectively cleaned using standard disinfectant procedures. Next slide, please. In closing, this is the trial design of our confirmatory study, IGNYTE-3, that will also serve as the foundation of our global patient access. IGNYTE-3 is a global randomized trial of RP1 in combination with nivolumab versus physician's choice in advanced melanoma patients with the primary endpoint of overall survival. The study is well underway, and it is expected to complete enrollment in 2030. Thank you very much for your attention, and I will now pass it back to Sushil to walk you through our commercial strategy.

Moving to Slide 17. Thank you, Kostas. We are now laser-focused on delivering TUDRIQEV to advanced melanoma patients. We know there are roughly 10,000 advanced melanoma patients a year in the U.S. who progress on a PD-1 containing regimen who could be candidates for TUDRIQEV plus nivolumab. Roughly 20% of these patients will present with superficial lesions only. 20% will present with both superficial and deep lesions and the remaining 60% tend to present with deep lesions only. It's important to remember that until today, there really was only one FDA-approved option. We very much look forward to providing a much-needed additional option for a broader population of these patients, including those with hard-to-treat visceral disease. Slide 19. As our team begins product promotion, our strategic focus will be to position TUDRIQEV as the first choice after progression on a PD-1 containing regimen. In an effort to generate awareness and demand for TUDRIQEV, our specific launch strategy will be grounded in 3 critical success factors. Firstly, instilling confidence to drive targeted and rapid adoption. Second, we really want to ensure a positive experience and seamless patient journey. And one of the unique groups we've established to enable this is the operational excellence team. This is a cross-functional group of oncology nurses, pharmacists and interventional radiology experts dedicated to working with new treatment centers to establish TUDRIQEV's operational workflows. The team's efforts will accelerate site activation and ensure that positive first experience and drive repeat use. And finally, we want to ensure that we deliver a meaningful value proposition for all stakeholders. Slide 20. During profiling last year, our teams met with nearly all of our early adopter accounts with several key insights identified throughout that profiling process. For example, our teams have a clear path in understanding who the interventional radiology and medical oncology champions are in roughly 90% of these accounts. The team has also received significant proactive requests for engagement immediately following approval. Slide 21. In regards to the early adopters that I just mentioned, these 200 accounts represent the accounts with the highest patient treatment potential based on claims data. They typically have the most well-integrated interventional radiology teams within their centers and all have prior intratumoral injection experience. In order to establish a strong launch foundation, our team's initial focus will be on establishing TUDRIQEV in the early account -- adopter accounts. These represent about 30% of the national melanoma patients treated annually. Once established in early adopters, we'll then add to our focus the next 250 accounts, which will represent in total, just over half of the patient treatment volume in the U.S. Longer term, we'll then roll into the next 750 accounts, which will allow us to reach about 80% of the potential patients treated annually. Early in the launch, the majority of our patients will be treated in the hospital setting with this evolving to a more balanced mix across hospital and nonhospital settings over time. Slide 21 -- Slide 22. Our team will continue to ensure payer coverage is in place to support usage. To date, the team has presented pre-approval information exchange presentations to national and regional payers who represent nearly 80% of medically insured lives, which we believe will help establish a streamlined process for coverage policies, and we'll continue to focus on this closely in the months to come. Whether patients are injected with TUDRIQEV by an interventional radiologist in the hospital for deep lesions or a medical oncologist or nurse in their office, meaningful procedure codes already exist. Finally, during the period of time when a new oncology product is approved and awaiting a permanent J-code to help facilitate reimbursement, we typically see a site of care shift from the community into the hospital setting where reimbursement is more easily supported. For the majority of patients with deep lesions, this is exactly where we want them to go since this is where interventional radiologists tend to practice. Once there, in addition to the procedure codes being in place, most accounts will benefit from 340B pricing since TUDRIQEV is administered on an outpatient basis. Finally, for oncologists who want to maintain that patient treatment continuity, they can begin administering nivolumab for up to 2 years in their office where reimbursement is already reestablished. So again, we believe that today's reimbursement model supports the patient journey that we're looking to establish with the availability of TUDRIQEV. Now this patient journey shown here on Slide 23, begins once a patient has progressed on the PD-1 therapy and the medical oncologist selects TUDRIQEV for their patient. The treatment selection process has become more streamlined given that our final label doesn't require prior BRAF-targeted therapy before starting treatment with TUDRIQEV. To expand a little further on the patient journey, once TUDRIQEV is chosen, the key next step in the process takes place when the multidisciplinary treatment team collaborates on establishing a patient treatment workflow, where the team will review the scan and create a plan. We surveyed more than 100 medical oncologists and 97% said they are willing and interested to collaborate with interventional radiology, and the IR community has been very enthusiastic to adopt RP1. Selecting an appropriate dose based on patients' tumors has also been simplified with our straightforward label dosing guidance of 1 milliliter per centimeter. Once product is in the channel, we will be implementing our drop ship next-day delivery model across treatment settings to quickly meet the anticipated demand while demonstrating a strong sense of urgency for patients. On the day of administration, TUDRIQEV injections are administered in the outpatient setting with standard cleaning procedures in place to help further support routine usage. Another critical step in the treatment journey is, of course, having a meaningful patient and provider support program in place to ensure that positive treatment experience. Next slide, Slide 24. On that front, I'm really pleased to announce that the ReplimuneConnect Plus, our patient and provider support program will be available in the coming weeks ahead of drug in channel. In addition to the traditional offerings, we are proud that ReplimuneConnect Plus will have a suite of concierge-level offerings, including on-staff nursing support to address treatment-related questions, text message reminders of scheduling and appointments through our case workers with additional support services available to caregivers. In establishing our depth of understanding of the advanced melanoma market as well as our patient resources, which include the development of Connect Plus, an important step in the process was ensuring we stayed close to the needs of our providers and the voice of our patients. With that, I'll turn it over to Emily Hill, our Chief Financial Officer.

Thanks, Sush. On Slide 26, I'd like to start by describing some of the pillars for the RP1 platform to drive our long-term success. First, we are proud to have our own in-house manufacturing facility based right here in Massachusetts, where we have the capacity to support not just the imminent launch, but long-term global commercial supply of RP1 and future RPx expansion. We expect to start shipping TUDRIQEV from this facility within approximately 60 days. We expect the cost for a typical TUDRIQEV real-world patient to be approximately $450,000 for a course of therapy. Overall, we believe this pricing is in line with comparable treatments for advanced melanoma and reflects the efficacy and differentiated safety profile of TUDRIQEV. On Slide 27, with this approval, we have derisked the RPx platform and now have the opportunity to unlock additional value. Our pipeline here shows how we will start to achieve that value for patients and shareholders. These trials are designed with the aim to bring benefit to patients beyond skin cancers. We are proud to have achieved the milestone of TUDRIQEV approval. We have a number of exciting milestones ahead of us. As we transition to a commercial company, we look forward to our first time reporting TUDRIQEV revenue and future data publications to support potential NCCN listings for RP1. In addition, we look forward to sharing updates from our REVEAL and HCC/BTC studies. Replimune has the right components to become a leading and highly valuable oncolytic immunotherapy company with an experienced team, a development plan guided by clinical evidence and now our first approved product. We look forward to delivering on our long-term potential. With that, I'll turn the call over to the operator for Q&A.

[Operator Instructions] Our first question comes from Ally Bratzel with Piper Sandler.

Big congratulations on the news today. Maybe just the first question for me. How has the widely publicized nature of the RP1 review process just affected physician and patient awareness and expected adoption trends? And then just a second one for me. Just looking at the efficacy data on the label, Section 14, it looks like FDA got their 91 patient 24% ORR analysis in there. Does that matter at all to docs or to payers? Just any thoughts there?

Thank you for the question. Firstly, you're absolutely right. We've had tremendous awareness. And I think one of the sort of benefits of the AdCom was just the tremendous sort of public and physician support and awareness it's created for RP1. And I think when you listen to the open public forum, it was very clear that this is a treatment that patients very much need and physicians want. So in that regard, we think this is actually a very positive thing for us and actually looking forward to being able to meet that demand. In terms of the 24% number, yes, we believe that's determined from the efficacy evaluable population from the FDA, and that's 91 patients with at least one non-injected lesion, which resulted in an ORR of 24.2%. We don't believe that that's going to be a challenge for us in any way, shape or form, given the unmet need, given, I think, the breadth of the profile, the efficacy and safety profile we bring to these patients who are clearly an unmet need, we don't believe this will be a significant hurdle to adoption and actually are very much looking forward to communicating the efficacy and safety benefits of TUDRIQEV to our prescribing population. And again, we don't also expect any payer issues with the data given the FDA approval. The data will also be submitted to NCCN in the very near future.

Our next question comes from Roger Song with Jefferies.

And my huge congrats for this achievement. Maybe 2 from us. One is given the label and then the pricing and the awareness, how do you think about this launch ramp going to look like? Second is in terms of the confirmatory study, understanding FDA used to have some comments around the design. And then just curious, have you get alignment on the confirmatory study comparator arm and then the primary endpoint? And then when should we expect to see the data from the confirmatory study?

Thank you for those questions, Roger. I'll take the first question. And on the confirmatory trial, I'll ask Kari Jeschke, our regulatory lead to take that one. So firstly, I think we have a very competitive label. And in terms of what the commercial uptake looks like, I think this is a profile that physicians and patients want, as I mentioned. But however, we really want to make sure that physicians and patients have a positive initial experience, and we're in the process of rehiring our commercial team. As I mentioned in my prepared remarks, we expect the initial uptake to be in hospital-based settings where temporary J-codes can be utilized and there are in-house interventional radiologists. And over time, Roger, we expect to expand into these community practices. We do believe that TUDRIQEV will become a new standard of care for patients who progress on a PD-1 containing regimen. And given the size of the patient population and pricing, we believe this represents a significant market opportunity. And then Kari, I think you had a question on the confirmatory trial and whether there was any communication with the agency in terms of the appropriateness of that study.

Right. Thank you. No, we have not had any request from the FDA to make any changes to that study. We've discussed it with them along the course of the way. And at this point, we're expecting to have our overall survival data endpoint readout in 2030.

Our next question comes from Daina Graybosch with Leerink Partners.

Congratulations from me as well. Many questions here. The first one in this 91-patient subset, the 24% that made on the label, that looks pretty much the same as what we saw in the briefing documents. And FDA separately had some concerns with response analysis for some patients. Was there no overlap? Or did they get over their concerns? I just wondered where that landed and how you ended up with this 91-patient response analysis? And then the second question is if you can help us understand the pricing breakdown for the average real-world patient where you quoted a price per course?

Okay. Thank you. In terms of the 91, our understanding is the patient -- the FDA determined an evaluable patient needs to have at least one noninjected target lesion. So that's all we can really comment in terms of how they got to the 91 patients. It was very similar, as you mentioned, to the sensitivity analysis they had in their briefing book that presented at the AdCom. And in terms of the pricing breakdown, I'm going to hand that over to Emily, who will address that.

Thanks, Sush. So we described a price of $450,000 per typical real-world patient. That's based on a volume use of 18 milliliters. As you may be aware, the volume of TUDRIQEV per patient is based on their tumor burden. And in our IGNYTE study, we saw a median use of 18 mls. Of course, there is a range of volume used in patients that will be above and below that. So we are basing the typical real-world patient price off of the median experience in the IGNYTE study.

Our next question comes from Anupam Rama with JPMorgan.