Replimune Group Q4 2025 Earnings Call Transcript

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Provided by Quartr
May 22, 2025
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Operator

Good morning and welcome to the RepliMune Fiscal Year Fourth Quarter twenty twenty five Financial Results and Corporate Update Conference Call. Currently, all participants are in listen only mode. This call is being webcast live on the Investors and Media section of RepliMune's website at repliimmune.com and a recording will be available after the call. I would like to introduce Arlene Goldenberg from Replimmune. Please go ahead.

Arleen Goldenberg
Arleen Goldenberg
VP - Communications at Replimune Group

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Replumin's fiscal year fourth quarter twenty twenty five business highlights and financial results. Leading the call today will be Sushil Patel, our chief executive officer. He will be joined by Chris Sarkey, our Chief Commercial Officer and Emily Hill, our Chief Financial Officer. After our prepared remarks, we will open the call for Q and A.

Arleen Goldenberg
Arleen Goldenberg
VP - Communications at Replimune Group

An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward looking statements, including without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations, plans, and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC, including our annual report on Form 10 ks and our Form 10 Q filed today. Forward looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made, including the non occurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of Replumine's normal course of business.

Arleen Goldenberg
Arleen Goldenberg
VP - Communications at Replimune Group

You are cautioned not to place undue reliance on these forward looking statements, which are made as of today, 05/22/2025. Replumune disclaims any obligation to update such statements, even if management's views change, except as required by law. With that, let me turn the call over to Susheel Patel, Replimune's Chief Executive Officer.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Thank you, Arlene, and welcome, everyone, to today's earnings call. We appreciate you joining us as we review our fiscal fourth quarter and full year 2025 results. Today, we'll highlight the significant progress we've made across regulatory, clinical and commercial as we approach the potential approval and launch of RP-one. You'll also hear updates on our confirmatory IGNITE-three trial, pipeline developments for RP-two and our financial position as we prepare for commercial readiness. I'll begin with a strategic overview before turning the call over to Chris to walk through launch preparation and Emily to cover our financials.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Repimmune was founded to pioneer the next generation of on clinical immunotherapy and is now poised to realize that promise with a substantial body of evidence supporting our mission. In particular, data from the IGNITE study shows that roughly one third of patients are able to achieve durable response in a high unmet need setting with few options. I am delighted with the tremendous organizational advances we've made, allowing us, if approved, to be ready for a strong commercial launch of our first therapy in anti PD-one failed melanoma. This would not have been possible without the efforts of the entire Replumium team. Over the past year, we have made significant regulatory progress resulting in a recognition of RP-one as a breakthrough therapy with priority review and a PDUFA date of 07/22/2025.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

We remain actively engaged with the FDA and recently completed the late cycle meeting and manufacturing inspections. The IGNITE-three confirmatory study is underway and has a primary endpoint overall survival. Enrollment in The US is on track with over 100 sites planned globally. While we have seen important advances in the melanoma treatment landscape, the unmet need remains significant. We believe upon FDA approval, RP-one will be well positioned to be the first choice for advanced melanoma patients who have previously received an anti PD-one containing regimen.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

This is based on a combination of compelling safety and efficacy data, a comprehensive understanding of the patient population and prescriber base, and a launch model optimized to unlock the potential of intratumoral injections. Building upon the strong systemic and visceral activity we've seen with RP-one in advanced melanoma, we are equally excited about our pipeline development, which are focused on the potential of deep lesion injections with RPX to benefit patients beyond skin cancer. We look forward establishing our RPX platform as a new interventional immuno oncology treatment paradigm, which we believe will be enabled through the collaboration between oncologists and interventional radiologists. Our US manufacturing facility has produced commercial inventory to support the RP-one launch with capacity to support long term global demand. We are well capitalized to execute on our commercialization plans and have recently completed the build out of our customer facing organization.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Now let me turn the call over to Chris Sarke, Chief Commercial Officer of Revenue, to discuss the RP-one launch in more detail. Chris?

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Thanks, Sush. Before I get into our commercial plans, perhaps a brief introduction for those of you on the call who I haven't yet had the opportunity to meet. I joined Replimune about two and a half years ago to help lead our commercial organization. Prior to joining Replimune, I helped spearhead the launch of Libtayo as a new standard of care for the treatment of cutaneous squamous cell carcinoma.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Upon approval, the successful launch of RP one will be my tenth oncology product launch that I've had the opportunity to be a part of. And now I look forward to helping to build Replumine into a leading oncology company. Our team is really excited and ready to launch RP one for a broad range of patients upon approval. We believe RP one will be well positioned for most patients who progress on a PD one containing regimen based on the deep and durable response rates, as well as the safety profile demonstrated in our ignite registrational trial. With our PDUFA date fast approaching, our primary focus has been on the commercial preparations.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

We have a deep understanding of the market landscape, prescriber adoption and referral patterns, and an established launch plan that's optimized for intertumor delivery across all customer segments. The commercial opportunity for RP one to help improve the lives of those with advanced melanoma is considerable. We estimate approximately thirteen thousand patients progress on or after PD one treatment annual in The US, and about eighty percent of these patients would be eligible for RP one distributed evenly across hospital and nonhospital settings. Importantly, RP one is administered in the outpatient setting and doesn't require hospitalization. For community based oncology, we believe the introduction of RP one will allow providers to maintain treatment continuity for their patients within their practice for the full course of RP one as well as nivolumab for up to two years.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

For superficial injections, we anticipate administration will most often take place in the patient exam room. And while medical oncologists may be some of the early injectors, the primary injector over time will likely be advanced practice providers. We expect that this approach will help support the broad and rapid adoption of RP one into clinical practice. From our research, we know that for patients in the advanced melanoma setting who would be candidates for RP one, about eight in ten will have deep lesions or a combination of both superficial and deep. In these cases, interventional radiologists will work closely with the oncologist and play a key role using image guidance.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Interventional radiologists are excited that RP one may afford them the opportunity to play an even greater role actively treating patients. Both oncologists as well as interventional radiologists are impressed with the data showing the systemic activity of RP one plus nivolumab in non injected visceral lesions, which provides them with added confidence in selecting tumors for injections. Interventional radiologists have also expressed that administering RP one is straightforward and can be readily adopted into practice upon approval. Importantly, procedural codes already exist to support RP one deep and superficial injections with a routine RP1 drug buy and bill reimbursement process that further minimizes barriers to access across all settings. The geographic distribution of patients with advanced melanoma allows us to be very focused and targeted in our launch efforts.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Even more importantly, there's a high and overlapping concentration of providers, primarily interventional radiologists and medical oncologists, who treat most melanoma patients. We've identified roughly 350 key accounts that we believe treat half of the melanoma population. Beyond that, we know that nearly all of these patients are being treated in health care settings that have interventional radiology on-site or readily accessible through existing referral processes, further supporting our belief in the broad and rapid adoption of RP one. Our comprehensive understanding of the market drove how we've built our commercial organization, which we believe will accelerate the launch of RP one. We recently completed the build out of our commercial infrastructure.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

The customer facing team has been trained and comprised of approximately 60 people with half focused on demand generation and the remainder on supporting pull through. A new and differentiated role we've created is the interventional radiology oncology coordinator or IIROC. This team has a significant level of experience working in the interventional radiology space. Their focus will be coordination between medical oncology and interventional radiology, ensuring that we're able to connect the dots between these functions while supporting RP one image guided administration. We also have a team of oncology nurse educators who will provide guidance on superficial administration, drive positive early experiences with RP one, and work across the medical oncology multidisciplinary team.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Our national accounts team is actively engaged with payers, and our field reimbursement specialists, regional marketers, and strategic account managers round out our customer facing teams. Our distribution model is now complete with specialty distributor agreements and key state licenses in place, which will support next day delivery to accounts across the country. At launch, our patient support hub, Replimmune Connect Plus, will provide critical services to patients and caregivers to ensure a positive treatment experience. You may have noticed several programs already in market. Our HCP unbranded awareness effort, the Oncolytic Frontier, which highlights the importance of collaboration across multidisciplinary treatment teams is live online now.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

A few months ago, we also launched a program called Melanoma Path, focused on unbranded disease education featuring real advanced melanoma patients and caregivers. Much of this content was created with the support of our advanced melanoma patient steering committee. We've been actively engaged with the melanoma community for the support of many key organizations, including the Melanoma Research Foundation. We're excited to be one of two presenting sponsors at their annual breakthrough consortium meeting later this year at ASCO, the consortium of 30 cancer centers of excellence collaborating to develop the most promising therapies in melanoma. As you can hear, we're excited with our progress to date and looking forward to hitting the ground running. Of course, ultimately our goal is to ensure that no patient is left behind and all appropriate patients for RP1 are offered this valuable treatment once available. Our team is confident in the plans we put in place to help deliver on this important goal. With that update, I'll turn the call over to Emily to discuss our financial results. Emily?

Emily Hill
Chief Financial Officer at Replimune Group

Thank you, Chris. I'm going to start today with an update on the investor relations front. We are excited to be in the process of planning an upcoming Investor Day for June 24. During Investor Day, you will be able to hear from our management team and leading key opinion leaders on the current melanoma landscape and the opportunity to deliver oncolytic immunotherapy to patients and our RP one roadmap for commercial success upon approval in anti PD one failed melanoma. Our KOL panel includes expert interventional radiologists, medical oncologists, and pharmacists in the melanoma space.

Emily Hill
Chief Financial Officer at Replimune Group

We will also share more about our future development of RP two, including our registration directed trial REVEAL in uveal melanoma and our study in hepatocellular carcinoma. Finally, we will discuss our strategy for RPX long term pipeline development. Now turning to our financial results for the fiscal year and quarter ended 03/31/2025. We ended the fiscal year with cash and cash equivalents totaling $483,800,000 as compared to 420,700,000.0 as the fiscal year ended 03/31/2024. Based on the current operating plan, the company believes that existing cash, cash equivalents, and short term investments as of 03/31/2025 will enable the company to fund operations into the fourth quarter of twenty twenty six, which includes scale up for the potential commercialization of r p one in skin cancers and for working capital and general corporate purposes.

Emily Hill
Chief Financial Officer at Replimune Group

This current cash runway excludes any potential revenue expected. Research and development expenses were 54,000,000 for the fiscal fourth quarter and a hundred and 89,400,000.0 for the fiscal year ended 03/31/2025 as compared to 42,600,000.0 for the fiscal fourth quarter and a hundred and 75,000,000 for the fiscal year ended 03/31/2024. This increase was primarily due to an increase in personnel related costs as we scaled operations in preparation for commercial launch, as well as consulting and facility related costs. Research and development expenses included 4,500,000.0 in stock based compensation expenses for the fiscal fourth quarter and 18,400,000.0 for the fiscal year ended 03/31/2025. Selling, general, and administrative expenses were 25,400,000.0 for the fiscal fourth quarter and 72,200,000.0 for the fiscal year ended 03/31/2025 as compared to 16,200,000.0 for the fiscal fourth quarter and 59,800,000.0 for the fiscal year ended 03/31/2024.

Emily Hill
Chief Financial Officer at Replimune Group

Selling, general, and administrative expenses included 3,800,000.0 in stock based compensation expenses for the fiscal fourth quarter and 16,600,000.0 for the fiscal year ended 03/31/2025. The company's net loss was 74,100,000.0 for the fiscal fourth quarter and $247,300,000 for the fiscal year ended 03/31/2025, as compared to a net loss of $55,100,000 for the fiscal fourth quarter and $215,800,000 for the fiscal year ended 03/31/2024. I will now turn the call over to the operator to open our question and answer session. Operator?

Operator

Thank you. Our first question comes from Anupam Rama with JPMorgan. Your line is open.

Anupam Rama
Anupam Rama
Analyst at JP Morgan

Hey, guys. Thanks so much for taking the question. With the PDUFA around the corner, what sort of medical education work are you going to be doing at ASCO ahead of the launch of RP-one? I noticed that you guys had a couple of posters at the conference. Thanks so much.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Good morning, Anupam. Thanks for the question. Yeah, we've got a busy ASCO coming up. We have a couple of important posters as you mentioned, in bullet bill data that we presented previously on IGNITE showing systemic and visceral activity including a non injected liver and lung metastases. What we'll be doing at ASCO is actually sharing what the response rate looks like when you inject superficial lesions versus a combination of superficial visceral lesions versus visual only lesions such as lung and liver metastases.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

And I think that data is going to show that there's going to be a strong rationale for physicians to want to inject deeper lesions to maximize outcomes for patients. We also have a bio distribution and safety poster, which is going to show that you can use routine cleaning, using disinfectants that are routinely available for physicians in their practices, and that RP-one is neutralized very rapidly. And then that also that patients don't see infections or their close contacts. So we're excited about that data and I think it's going to build on the evidence of the data we previously presented with the IGNITE data.

Anupam Rama
Anupam Rama
Analyst at JP Morgan

Thanks so much for taking our question.

Operator

Thank you. Our next question comes from Roger Song with Jefferies. Your line is open.

Roger Song
Roger Song
Analyst at Jefferies Financial Group

Great. Thanks for the update and taking our questions. So maybe given the dynamic for the launch between the oncologists and interventional radiologists, can you just give us some color around your expectation for the launch trajectory, considering some of them are superficial only, the lesion and then some of them are mixed and then some of them are visceral only? Thank you.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Thanks, Roger. This is Chris. So we are anticipating a broad and rapid adoption across, hospitals and communities, really, with a heavier lift initially within the hospital setting. We've identified, as you heard, around three fifty of our top accounts across the country. We, by the time of the launch, expect that roughly 150 of these accounts will have experience with intramural injections or have been trained on that by the time we get approved.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

The vast majority of these accounts will have access to interventional radiology within their centers. You know, we've done a lot of research, as you can imagine, across the space between medical oncologists and interventional radiologists, and over 90% of the folks we've spoken to are willing to utilize RP1 routinely upon approval. And so when you think about this level of excitement, the familiarity, and experience, this really does support broad and rapid adoption of RP1 post approval.

Roger Song
Roger Song
Analyst at Jefferies Financial Group

Got it. Thank you. If I can have a follow-up question. Assuming you will get approval for the PD-one cell, the melanoma in the upcoming PDUFA date, what would be your NCCN listing strategy to maybe potentially expand to some other subgroup and then also maybe beyond the melanoma like a CACT? Thank you.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Thank you for the question, Roger. In terms of the IGNITE data, obviously, we'll be able to get approval straight away when we get the FDA approval for anti PD-one failed melanoma. And yes, we would though still submit that data once we have the publication, which we're hoping to have around the time of the PDUFA date, which will again just further sort of solidify our position in NCCN, although it's not necessary as we will have FDA approval. As we think about future indications, I think what we're going to do is obviously see what the data looks like from those different indications, whether that's non melanoma skin cancers such as SURPASS or the Articus data in solid organ transplant. We'll be publishing the data and then determining the best path to provide access to patients, Roger.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Yeah. In addition to that, Roger, upon approval, we'll be immediately submitting our information to the drug compendia so that hospitals can download this into the system. What we've done is to make sure that we have rapid adoption within the electronic medical record systems as quick as we can. On day one, we'll be submitting a package to the companies that represent roughly 85% of all the electronic medical records databases in the country. And we put in place sort of a reactive mode as well so that for those that don't readily adopt into their EMR system, our customer facing teams will have an app they can go to right away, reach out and let the third party group we're working with know where those haven't taken place yet, and we'll resolve those issues very, very quickly to ensure we minimize barriers to access, as Sush was saying.

Roger Song
Roger Song
Analyst at Jefferies Financial Group

Excellent. Thanks for the comments. Congrats.

Operator

Thank you. Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.

Jonathan Chang
Senior Managing Director at Leerink Partners

Hi, guys. Good morning. Thanks for taking the questions. Congrats on the progress and for hosting what I believe is your first earnings call. First question, can you discuss the impact you're seeing from the recent regulatory changes and can provide any color on recent FDA interactions?

Jonathan Chang
Senior Managing Director at Leerink Partners

And then on second question on IGNITE, can you discuss the translation of response rate into metrics like PFS and OS? And what benchmarks are you pointing to for PFS and OS in the anti PD-one failed melanoma setting? Thank you.

Emily Hill
Chief Financial Officer at Replimune Group

Thanks, Jonathan. This is Emily. I'll take the first segment of your question. So, just as a reminder for those on the call, we received breakthrough designation late last year and then submitted our BLA for RP-one in PD-one failed melanoma. Our BLA was accepted in January with a priority review, and since that January, we've been responding to information requests from the FDA in a timely and thorough manner.

Emily Hill
Chief Financial Officer at Replimune Group

We're very grateful to have seen committed and consistent engagement from our review team, and we haven't seen any changes to the cadence of that commitment. Having recently completed both our late cycle meeting with the FDA and our manufacturing inspections. We're very pleased with the outcome of those interactions, and we believe there are no impediments. We're on track for our July 22 PDUFA.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

And Jonathan, just to address your second question, and yes, you're right. This is our first call, which we're very excited about. So in terms of the data that we've seen for IGNITE, just as a reminder, we've seen around a third patient a third of patients achieve durable responses, which you look at median duration response of more than twenty months. This is a single arm study as you're aware and so obviously there are some limitations of PFS and OS in this study. However, we've seen a PFS around four months and their overall survival which I think is actually very impressive where we've seen more than fifty five percent of patients still alive at three years And so we think that's going be very meaningful relative to other options in this space.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

You asked about the benchmarks we should be using and I think it is important to remember that you know the IGNITE did use a very strict criteria for anti PD-one failure and there isn't exact apples to apples comparisons, but if you think about some of the other studies and assets or molecules used in this space such as ipinivo or optulag having failed either ipinivo or optulag in the frontline setting, you see about a twelve percent response rate and typically physicians and KOLs would tell you would not expect to see median overall survival of more than twelve months. So I think that's a reasonable benchmark that most people use. Further checkpoint inhibition after failure of prior checkpoint inhibition really only results in a response rate of six percent or seven percent with very modest overall survival benefits.

Jonathan Chang
Senior Managing Director at Leerink Partners

Understood. Thanks for taking my questions.

Operator

Thank you. Our next question comes from Allison Bratzel with Piper Sandler. Your line is open.

Allison Bratzel
Allison Bratzel
Senior Research Analyst at Piper Sandler Companies

Hey, good morning. Thanks guys for taking the question. Just on the confirmatory IGNITE III trial, I think you initiated dosing of patients last summer. So, could you just talk to your experience to date with that trial and what you're seeing in terms of enrollment, opening of trial sites and things like that. And just expectations on a timeline for completing enrollment.

Allison Bratzel
Allison Bratzel
Senior Research Analyst at Piper Sandler Companies

Any color there would be helpful. And second, could you talk to your expectations on the potential label or label discussions for RP-one and just what gives you confidence in a broad label and achieving broad access? Thank you.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Good morning, Allison. Thanks for those questions. So just in terms of IGNITE or RPHA-three, just as a reminder for people, this is a large randomized study, a confirmatory Phase three trial with 400 patients where we're combining RP1 with nivolumab versus limited dealers choice, which includes Optualag chemotherapy or single agent checkpoint inhibition. This is a trial that's going to have more than 100 sites globally and as you can imagine we've been providing the agency the updates on the timelines for the overall study and enrollment updates on a regular basis. We expect the trial to take a couple of years to complete enrollment given the study population and size of the study.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

And as you can imagine right now, we're intentionally focusing on enrolling in US sites given the upcoming PDUFA and we realize that at approval patients will not want to be randomized onto the control arm. So given that we're really focusing our efforts and driving enrollment in The US, it's going very well. There's a lot of excitement around the trial and what we're actually now doing is spending a lot of time on the rest of world expansion so that at PDUFA we would continue to see enrollment in that study in countries such as The UK, Australia and Europe. And again, there's equally high level excitement from ex US investigators around the trial. We look forward to speaking to many of them at the upcoming ASCO meeting.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

And then you asked the second question, I believe, on the broad label. Is that correct? Yeah, just as a reminder, IGNITE really enrolled a real world population which included really pretty much every type of anti PD-one failed presentation and we saw a consistent benefit across all the subgroups. So we would expect the label and as you know now that we've finished the late cycle meeting we'll be going into labeling discussions to very much reflect the study population that we investigated in the NIGHT trial and would expect a label to reflect that broad population.

Allison Bratzel
Allison Bratzel
Senior Research Analyst at Piper Sandler Companies

Thank you.

Operator

Thank you. Our next question comes from Evan Seigerman with BMO Capital Markets. Your line is open.

Analyst

This is Connor on for Evan. Thanks for taking our question. Ahead of the potential commercial launch, can you maybe talk a little bit about how you're planning for manufacturing resiliency, including second sites to provide RP1 product? And then I also believe you have an attractive cost of goods profile with RP-one. Can you maybe remind us what the drivers are there? Thank you.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Yes. So just in terms of the manufacturing, and again, as a reminder, we're manufacturing our own product to that facility that was designed specifically for the manufacture of RPX in framing them in The US. And yes, you're right, we have attractive cost of goods. It was one of the strategic reasons that we actually invested in the manufacturing early and we do anticipate to have a off the shelf product that physicians will utilize, order and use the next day. We'll have sufficient inventory for, you know, rapid and broad support at launch and also have sufficient supply to ensure that we have mid to long term supply for expansion of RP-one.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

In terms of the capacity, again, we have a lot of redundancy within the facility to produce sufficient supply way beyond the initial launch. And we're also looking to produce other product including RP2 and RP3 at the facility in the future.

Analyst

Great. Thank you.

Operator

Our next question comes from Peter Lawson with Barclays. Your line is open.

Peter Lawson
Peter Lawson
Analyst at Barclays Capital

Great. Thank you so much. I wonder if you could just talk through any of the gating factors that exist between now PDUFA date, especially on CMC? And then kind of your your thoughts around, kind of in light learnings from the two launches, how you're thinking about, giving revenue guidance and thinking about market penetration? Thank you.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Yes, I'll just take the first question. As I mentioned earlier, we did complete our late cycle meeting and we did complete our factoring inspections both at our Milton Park facility, which does our process validation and analytical methods and then the main manufacturing facility in Framingham. So, we feel we're well positioned there. And as you would imagine, there was discussions on CMC and other clinical questions at the late cycle meeting and we remain on track.

Emily Hill
Chief Financial Officer at Replimune Group

In terms of revenue guidance, I anticipate that we'll be providing metrics for you to track the success of the launch, including ultimately patient numbers and payers and we'll hold off on revenue guidance until further into the launch.

Peter Lawson
Peter Lawson
Analyst at Barclays Capital

Thank you. Is there any kind of formal or informal feedback you've got from the FDA regarding, I guess, manufacturing or any other components there?

Emily Hill
Chief Financial Officer at Replimune Group

Yeah. I mean, of course, we are under an active BLA review. We have completed the inspections, and so there is formal feedback associated with those inspections, and none of that formal feedback should provide a bottleneck towards our July 22 PDUFA.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

Peter, thank you for the second question. You know, while there have been, you know, significant advances in the treatment of advanced melanoma in recent years, there still remains a pretty significant unmet need when it comes to either deep responses, durable responses, or safety profiles. And so, we know that today when patients progress on a PD-one, they start on a PD-one therapy, the frontline setting, half of them are going to progress within six months. And so for these patients, they don't have oftentimes six, eight, or ten weeks for the next treatment option to be employed. When we talk to physicians in the community, melanoma experts around the country, when they start patient on a treatment and it's working well and it's tolerated well, they they will rarely remove that patient from treatment.

Chris Sarchi
Chris Sarchi
CCO at Replimune Group

And so our position is that RP one will be positioned as a first line option for patients who progress on PD one therapy based upon our deep and durable response rates, our safety profile, and our next day distribution and off the shelf use of convenience, which, again, really helps to support broad and rapid adoption once approved.

Peter Lawson
Peter Lawson
Analyst at Barclays Capital

Thank you.

Operator

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Shasheel Patel for closing remarks.

Sushil Patel
Sushil Patel
CEO & Director at Replimune Group

Thank you. So in summary, it's been a productive few months and with a very exciting inflection point as we prepare for our first approval and commercial launch with RP-one. We look forward to our upcoming milestones including data updates on our deep and visceral activity and safety at ASCO and our upcoming Investor Day and potential approval announcement. Finally, just want to acknowledge everyone at Refugu. I'm proud of the efforts of our team and want to thank them for their dedication as we work to deliver important treatment options to patients in need. Thank you for joining our call today.

Operator

Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.

Executives
    • Arleen Goldenberg
      Arleen Goldenberg
      VP - Communications
    • Sushil Patel
      Sushil Patel
      CEO & Director
    • Chris Sarchi
      Chris Sarchi
      CCO
Analysts
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Key Takeaways

  • RepliMune’s lead therapy, RP-1, holds Breakthrough Therapy designation with a PDUFA date of July 22, 2025, and the company has completed its FDA late-cycle meeting and manufacturing inspections ahead of potential approval.
  • The confirmatory Phase III IGNITE-3 trial of RP-1 plus nivolumab versus physician’s choice is underway at over 100 global sites, with U.S. enrollment on track and overall survival as the primary endpoint.
  • RepliMune has built a 60-person commercial organization—including novel Interventional Radiology Oncology Coordinators and oncology nurse educators—secured specialty distribution for next-day delivery, and launched a patient support hub to ensure a streamlined RP-1 rollout.
  • RepliMune estimates ~13,000 U.S. patients progress after anti–PD-1 therapy each year, ~80% of whom could receive outpatient RP-1 injections, and it has mapped ~350 key accounts to drive rapid adoption among both oncologists and interventional radiologists.
  • With $483.8 million in cash and equivalents as of March 31, 2025, RepliMune is funded into Q4 2026, reflecting increased R&D and SG&A spending to scale operations for the RP-1 commercial launch.
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Earnings Conference Call
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