Replimune's Second Quarter Fiscal 2027 Earnings Conference Call - REPLIMUNE GROUP INC

Good day, and thank you for standing by. Welcome to the Rapid Immune's second quarter fiscal 2027 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. I would now like to hand the conference over to your first speaker, Arlene Goldenberg, Head of Investor Relations. Please go ahead. Thank you, Operator, and good morning, everyone. Thank you for joining us for RepLemune's earnings call following the launch of TudraCab. Earlier today, we issued a press release reporting our financial results for the fiscal second quarter ended September 30, 2026. The release accompanying today's webcast is available in the Investors section of our website at replimune.com. With me on today's call are Sushil Patel, our Chief Executive Officer, Michelle DiNapoli, our chief commercial officer, and Emily Hill, our cheap financial officer. Before we begin, I'd like to remind everyone that today's remarks include forward-looking statements within the meaning of the federal securities laws. Items we discuss today will include forward-looking statements about topics including, but not limited to, our future financial performance, projections and assumptions about the commercial launch of Sujicab, and management's plans and objectives for future operations. Actual results may differ materially from those presented or implied by these forward- looking statements and are subject to risks and uncertainties that could cause actual results to differ. We encourage you to review the risk factors in our most recent Form 10-K and Form 10Q on file with the Securities and Exchange Commission. Any forward-looking statements that we make on this call are based on our assumptions as of today. Unless required by law, we undertake no obligation to update or revise these statements as a result of new information or future events. With that, I'll turn the call over to Sushil. Thank you, Arlene, and thank you for joining us today. This is a defining moment for RepRimmune. TutorKev is the first commercial product from our RPX platform. We are excited to now be delivering TutorKev to patients, and its availability has been met with excitement from the melanoma community. We are very encouraged by the early traction, and in just the first three weeks since launch, a number of leading melanoma institutions have already ordered, and many others have identified patients to treat. The unmet need and demand are clearly there. Most of our prepared remarks on this call will focus on the commercial launch, including how we will track progress and our plans to bring Tudor Kev to as many patients as possible. Michelle will provide more detail in a few moments. Importantly, the Tudors Kev broad label reflects how physicians prescribe, and they're enthusiastic about it. It allows them to treat a range of patients progressing on PD-1-based therapy with no requirement for prior BRAF-targeted therapy. Since approval, we have moved with urgency and focused on the following three priorities. First, and most importantly, meeting the unmet need of patients and the physicians who treat them. There are approximately 10,000 addressable patients in the U.S., and nearly 8,500 patients die of melanoma every year. Once patients fail PD-1-based therapy, treatment options are very limited, and we are seeing real urgency from healthcare providers to gain access to TutorCare. Next, ensuring supply is ready and getting product to patients quickly with next-day delivery. We are ready to meet the demand with more than a year of inventory on hand produced at our in-house manufacturing facility. Finally, we are focused on attracting top talent to rebuild our commercial team. We are now almost fully staffed and right-sized to execute our launch plan. With that, I'll turn over to our Chief Commercial Officer, Michelle. Thank you and good morning, everyone. I am thrilled to lead the launch efforts to bring Tudor Kev to patients in need. In the first few weeks of Tudor Kev availability, what has struck me most is the positive reception from melanoma treaters and the sense of urgency to adopt. Both academic and community oncologists, as well as interventional radiologists, are showing real interest in using Tudra Kev and eager to include it into their practice quickly. They value the broad label, which provides them the flexibility to treat the real-world population they see in their clinics and appreciate the ability to bring this therapy to their patients. TruDraCav can be delivered the next day and injections happen in the outpatient setting so physicians can treat quickly which matters for patients who often cannot wait. TruDracav has been utilized by oncologists and interventional radiologists and feedback has been positive. We're encouraged by the number of accounts that have identified and already started treating patients. Our top priority is setting up each account so that customers and patients have a positive first experience that supports repeat orders with optimal utilization that is a focus of our full customer facing team which is in place and engaging with target customers it includes account managers supported by our operational excellence team a cross-functional group of oncology nurses pharmacists and interventional radiology experts who partner with the facilities to establish Tudor Kev workflows. To date, we have held more than 50 meetings with melanoma treaters and sites are putting treatment plans and workflows in place. We've been especially encouraged by the reception from interventional radiologists and we will continue working with this group across our priority accounts to ensure image guided injections can be done routinely. Interest is also extending beyond our initial target list of 200 accounts. We have received proactive outreach from community practices driven by the unmet need of their patients, and accounts with no prior Tudor Kev experience have already treated patients in these first weeks. This gives us confidence that this modality can be broadly adopted. Today, we aim to provide metrics to highlight the successful trajectory of our initial launch. We think about the launch as a funnel. First, we are focused on engaging the right accounts to identify patients and drive demand for Tudor Kev. Next, we secure access and establish operations to support a positive experience for both the facility and patients. Accounts then order products and patients are treated. Today, we're pleased to report our progress at each stage. First, engagement. We have had proactive engagement with more than 70% of our initial 200 target accounts, reflecting real interest in Tudor Kev and our team's ability to reach priority customers. Next, access. About 20 accounts have swiftly placed Tudra Kev on formulary. And last, orders. As of Friday, over 15 institutions have written one or more Tudor Kev prescriptions, a strong start in less than 20 business days. To give some additional color, some of the highest volume melanoma institutions, including Moffitt and Memorial Sloan Kettering, have moved quickly to add Tudra Kev to formulary and treat patients. The speed of formulary action shows that access is a priority and demand is there. Additionally, other sites have told us that they are expediting and in some cases bypassing the usual formulary review to get Tudor Kev to patients without delay. We think these examples demonstrate the unmet need and the urgency that exists to adopt Tudra Kev and momentum continues to build each week. In terms of securing coverage, Tudr Kev was very rapidly listed in the NCCN guidelines as a category 2a recommendation to date many commercial payers have already published policies that cover to label which includes retreatment if clinically appropriate we are very pleased with how rapidly these policies have been established as they include major national and regional payers influencer policies that other payers commonly reference are also in place and favorable for two truck of coverage these policies already represent a majority of commercially covered lives in addition Medicare coverage has been established so in totality we have rapidly secured broad coverage in line with the Tudor cab label across patients we expect to treat we anticipate other policies to be in place in the near future all of this progress was achieved with the miscellaneous J code we submitted for a permanent J code which we anticipate having in place by April 20 27 and at At that time, we expect this to foster even broader adoption, including by the community. We have also made it easier for patients to get started on Tudrakev. RepliMe and Connect Plus, our patient support program, is now live, providing a comprehensive range of support services to facilitate patient access. In summary, we are very pleased with how the first weeks of launch are going. There is clear patient demand for a well-tolerated therapy after progression on a PD-1 based regimen and we are seeing great interest from melanoma treaters. We are encouraged with how swiftly oncologists and interventional radiologists are adopting both superficial and image-guided injections and their ability to integrate Tudor Kev into their practices. We are very excited about the early days of bringing Tudra Kev to patients and I'm confident in the team's ability to execute. With that, I'll turn it over to Emily. Thank you, Michelle. As a reminder, RepliMun is a March fiscal year company, so today I will provide an overview of our fiscal second quarter results. We did not record product revenue in the quarter as first commercial shipments occurred in early October. We look forward to reporting our first product revenue and our fiscal third quarter. Research and development expenses were $34.4 million for the quarter compared to $49.3 million in the fiscal first quarter. Selling, general, and administrative expenses were $21.9 million compared to $19 million in fiscal first quarter. The increase reflects the build-out of our commercial organization, including field hiring, launch readiness, and patient support programs. Net loss for the quarter was $57.1 million, compared to a net loss of $69.8 million in fiscal first quarter. We ended the quarter with $307.8 million in cash and cash equivalents. This includes the net proceeds of $141 million from our August offering. For reference, we held $195.3 million in cash at June 30th. Based on our current operating plan, we expect our cash position will enable us to fund operations for greater than 12 months. That plan includes the commercial launch investments for TudorCav and continued funding of IGNITE3 in support of our REVEAL study in uveal melanoma. Let me give you a few additional points to help you model the launch. The list price of TudraCav is $450,000 per course of therapy before customary rebates and discounts. The actual cost per patient will vary with tumor burden and the number of cycles a patient receives since dosing is based on the size of the lesions injected and patients may receive eight or more cycles because product is shipped for each treatment visit and a course runs over several months revenue from a patient starting therapy may be recognized over more than one quarter we will not be providing revenue guidance at this time with that operator please open the line for questions As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, press star 1 again. Please stand by while we compile our Q&A roster. And our first question will come from the line of Evan Segerman of BMO Capital Markets. Your line is open. Hi, guys. Thank you so much for taking my question. You know, as we think about kind of the cadence of the launch and getting, you know, the large centers online, what are some of the gating factors that we should really be drilling down in our model? And as we look towards next year, appreciating that you're not giving guidance, but any sort of metrics, number of patients, or even accounts engaged that we shouldn't be doing? What should we be thinking about as we model? Thank you so much. Thank you, Evan, for the question. Yeah, in terms of some of gating matters, I mean, so far, as I mentioned, the launch is going very, very well. We've really been surprised and pleased with the level of enthusiasm and the ability for customers to quickly get Tudor Kevon formulary. I'm going to hand over to Michelle and then Emily to talk a little bit around some of the cadence of things that we would expect in the coming weeks and months, and then Emily will talk a bit about the metrics, including why at this point we're not providing patient numbers. Thank you. I think we are thinking about the launch as a funnel, as I said in my prepared remarks, but we're very excited about how we're seeing facilities move through the process to access Tudor Kev. So we think about the cadence of, are we engaging with the right melanoma treaters? Is our team able to execute and help facilities operationalize workflows? are these accounts then ordering and identifying patients and putting plans in place to make sure it's a seamless process so as we've stated I mean as of this morning we have closer to 20 accounts who have ordered and put those workflows in place and have begun treating patients and we are continuing to see that momentum I mean I were looking forward to in November several more of these facilities have tutor keV coming through formulary so we would expect them to be treating. And we think by the end of the year, we could sort of double the number of accounts that we're seeing already initiate patients. Hey, Evan, I'll just add some commentary on the metrics we're providing now and the metrics that we think will be useful to track. We obviously thought very carefully about the metrics we could provide at this point, you know, as we mentioned, just 20 business days into the launch that would help you gain insight into our early success, and then track our strong trajectory. As you know, Chudrakev treatment is based on a patient volume with about one mil per centimeter used for patients. So, as we see these initial robust orders come in, it is difficult for us to track the exact patient numbers. And therefore, as Michelle communicated, the most useful metrics to track at this time are those that follow the funnel, so accounts on formulary and accounts that have written a first script. And we would expect to provide updates on those metrics. Once we've seen a cohort of patients complete their eight or more cycles, we'll start to gain insights on the average volume used by patients in the real world, and we'll provide further insight at a later time. Great. Thank you so much. And our next question will be coming from the line of Allison Bradsell of Piper Sandler. Allison, your line is open. Hey, thanks. Good morning, and thanks for taking the questions. Just a couple for me. So I think, you know, you talked about the number of institutions who have prescribed TutraCav. Could you talk to maybe how many have actually administered a dose and what is the typical time from prescription to first injection? And then among accounts maybe that have prescribed but not yet treated, you know, what's the most common holdup, you know access scheduling with interventional radiology or something else. And then last question, but just you know just thinking about the average price per patient you know for patients maybe identified and started on treatment so far do you have a sense just on how tumor burden compares with what you saw in IGNITE and how representative IGNite is of the real world population. Thank you. Thank you, Alison. I know there's a number of questions there, so we'll try and break that down. Just as a reminder, though, Tudor Kev is delivered the next day and can be used rapidly by accounts, and we're definitely seeing that. I'm going to hand over to Michelle. We'll cover a couple of those topics in terms of prescriptions, et cetera, time to dosing, and any sort of holdups that we've been seeing. Yes, thank you. I think one of the features, as Tush has said, of our distribution model is that we can deliver the next day. So we have seen accounts, when they order, they are administering to their patients pretty quickly. We've seen cases where they've ordered on a Friday to dose a patient on Tuesday. We have seen instances where accounts have ordered on Monday and started the patient on Tuesday. So our distribution is working for kind of just-in-time treatment, and I think what we're seeing is the accounts are engaging oftentimes with us to help put their operational workflows in place with expediencies because they have patients in mind and then treat that patient pretty quickly after getting those workflows in play. In terms of the interventional radiologists, in these priority accounts, we've seen a lot of receptivity and enthusiasm from this group as well. They're part of that workflow process. And that's really key and a priority for us is to ensure the oncologist and the interventional radiologist are making these plans together. We find that that is sort of the most seamless approach. And as I said, there's been a lot receptivity on the part of the interventionable radiologists to fit this into their approach as well. And a best practice of that is just being very planful, right? If we can schedule, what they're finding is if they can schedule the patient for their eight cycles with interventional radiology when appropriate, that is working best. And we're seeing that be syndicated in these other accounts. I think there's a question on average price and sort of volume and whether that's going to be similar to Ignite. And in general, Alison, Can I just say it's a little too early to get into that? Obviously, that's something we're going to be monitoring as we have more data, but I'll let Emily add any additional color to that. Yeah, I think, you know, the only thing that we are watching is we do believe that IGNITE was a representative population of the real world. What we are seeing in early days is obviously physicians now have experience with injecting deep visceral lesions. And as Michelle mentioned, we are Seeing Early Adoption by Interventional Radiologists. Yeah, and in terms of holdups, I wouldn't say that there's been anything that's been a major hold-up. I mean, these accounts just work at different places, and some have been able to move very, very quickly. Others have more sort of, you know, restricted sort of guidance on when they have P&T, et cetera. So it's not because the physicians within those practices are not eager to treat, to do care. It's just sometimes they just take a little longer, and we've got examples of accounts where it's said, it's all on you guys. You provide us everything we need. It is really on us just to go through our process, and they are very much committed to doing that. And in terms of your final question, well, your first question on prescribing, all of those accounts have ordered and will be treating patients, and most of them are already treated patients. Excellent. Thank you. And our next question will be coming from the line of Dana Graybosh of Leerink Partners. Your line is open. Hey, good morning. Thanks for the question. I've got a bill on for Dana. So, which one for me? Of the 140-ish institutions you engage in your initial 200 target, can you give us a breakdown of their readiness to start ordering and prescribing? And what are the, I guess, the critical path steps for an institution to start ordering? Are there any specific challenges that have been surprising? And how has the commercial team been addressing that? Thank you. Yeah, thanks for the question. I'm going to hand that over to Michelle, who will go into some detail on that. Yeah, thank you. So, of the 140 accounts, I think the way that this is working is our team is engaging early on to help understand what processes they have in place. Each institution operates a little bit differently, but often the first step is getting the tutor cap on formulary, so there is access within the institution. But very important, and sometimes that can be bypassed, and we've seen that be bypass because patients are in need. I think overall, you know, overarchingly in my experience and what we're seeing here is that when there is an unmet need, these physicians in these facilities will do what they need to to get the drug to patients. So we're see that happen here. But our team has been very successful in engaging and oftentimes being proactively asked to help partner with these facilities to put these workflows in place that include the interventional radiologist. And we think that's the best way to set these accounts up well so that they can not only have a successful first patient treatment, but also subsequent patients can go through the process and have a seamless experience. So the bottleneck isn't really something that, it's certainly not anything that's insurmountable. It's just working through the process. And we're seeing every day more and more accounts sort of come online, so to speak, so that they can successfully deliver Tudraka. We're also seeing accounts outside of this initial 200 that don't have experience or haven't had experience with Tudrakas that are sort of figuring out the process and have successfully treated patients as well. So as you know, we had said that gives confidence that this can be therapy that can be adopted quite systematically. Yeah, one thing to Maybe we have an operational excellence team that really works cross-functionally at the site, including with pharmacy, IR, the oncologists, and really all the necessary departments and functions to make sure that we can actually address all the steps that they need to go through, and that's been very successful so far. And we've had more than 50 of those meetings to really make sure that all the workflows are established and things go smoothly. So, again, haven't really seen any major holdups. As Michelle said, every account is a little different, and it just can take more time in some accounts versus others. Got it. Thank you. And our next question will be coming from the line of Anya Pimrama of J.P. Morgan. Your line is open. Hey, guys. Thanks so much for taking the question, and congrats on some of the early progress here with the launch. I wanted to ask a quick question. In your opening comments, you talked about continuing to evolve the sales force a little bit. Can you remind us what you had in place prior to the approval regarding the Salesforce, where you are now, and kind of what hires or deployment needs to happen here in the next couple weeks and months? Yes, so thank you for the question. We are very encouraged with how quickly we've been able to rebuild the commercial team overall. specifically to the sales force we have all we've 23 account management positions that are in place and an operational excellence team that is almost fully in place but this group has been out engaging customers as you saw we're having proactive engagements we've penetrated over 70% of our target accounts so we feel like we're in a very good state of copacetic state for the sales force and the customer facing team and I'm sorry now your last part of the question yeah what else needs to be done in the next couple weeks and months on the sales force to get it you know I think complete yeah I think yeah thank you I think we're in good shape and the team is just going to continue to execute in terms of driving breadth and depth in these accounts yeah I can add up on this really nothing on the Salesforce side right now, beyond just completing the training, getting out the accounts and customers, and completing the engagement with 200 accounts, which I think will happen quite rapidly, and then moving beyond that initial 200 to the next wave of accounts. But really, on the Salesforce and Michelle's team, there really isn't much. There's a couple of internal positions we're trying to hire, which should be filled very quickly. Thanks for taking the question. And our next question will come from the line of Roger Song of Jefferies. Roger your line is open great um thanks for taking the question a couple quick ones one is the do you have some visibility regarding the patient are being treated and intended to be treated they are superficial only patient or our lesion patient or visceral mix and then also in terms of formulary so when When the drug is put on the formulary, do they have some limitation on how much the volume it could be reimbursed? Is that up to 80 milliliter or that's based on the tumor volume? And just lastly, when you launch, get approval, you have some rough timeline on the focus six months for the early adopter in the next nine to twelve months for that the next wave 450 accounts just curious now you're thinking based on the experience you have in this timeline can be accelerated and then how should we think about the site engagement versus the first order from those two waves 200 accounts and then 450 accounts thank you and just to take your first question no We're definitely seeing adoption of both superficial as well as image-guided injections. And as you know, Roger, this has been a big focus of ours. We really believe to sort of maximize the opportunity and benefit for patients that we need to do those image-aguided injections, and in these early few weeks, we're definitely seeing those image guided injections already happening, which is, I think, encouraging. It's something that we'll continue to focus on. I'll let Michelle talk about formulary. My only comment on formulary is a lot of it is actually dependent on the payer policies, and they haven't restricted us in any way in terms of retreatment, so I wouldn't expect the institutional formularies to be more restrictive than the payer formularis, but Michelle, you can comment on that. Yes, I think that's exactly right. So the short answer is no, we're not seeing any restrictions on formulary in terms of usage. We all have been supportive of Tudorkev to label. I think importantly, as Michelle had said, we are very encouraged with how quickly published policies have been put in place and these are really exactly to the tutor kept labels supporting not only the eight cycles but retreatment as necessary there are no volume restrictions and any of these published policies in fact some of the policies the it allows for doses up to 24 doses so if the label is eight and then retreatment so but nothing on volume which is obviously very encouraging then your next question was around launch success and yes our priority in the first six months we've said is in these top 200 accounts that is because they cover a high concentration of melanoma patients about 30% that are treated nationally each year annually within the US we plan to think about accelerating into the next wave of 250 accounts that would represent another 20% of the melanoma population some of these places have already proactively engaged with us some have already begun treating patients on their own be which just I think reflects the demand that's out there and the unmet need that is out there so we will continue to assess accelerating moving into these sort of regional centers and then into the community as swiftly as possible but I I think, Roger, as Michelle said, what's important for us is we're doing this right. And I think if we're going to optimize treatment and get repeat treatments and have a really good patient and physician experience, we want to make sure we do it right. So certainly, if we are ready to accelerate into that next wave, given how good the early traction has been, we'll certainly be able and ready to do that. But we'll do it at the right time when we feel it's ready and that we've fully penetrated those 200 accounts. Excellent. Thank you. And our next question will be coming from Mubeen Moshaheb of Cantor. Your line is open. Hey, good morning. This is Mubean on . Congrats on all the progress and on the first shipment. I have one particular question on the superficial versus the deep injections. Can you talk about the proportion of patients that are getting the superficial injection versus a deep injection, and how does that affect the volume of treatment? Thank you. I'm sorry, could you repeat the question? I think I got the volume. Was it the volume used for superficial versus deep? Yeah, exactly, yeah. Again, it's too early to comment on volume differences by lesion type and lesion location. In the past, when we've looked at this on IGNITE, we have seen that when you do deep injections such as lung and liver, they tend to have a higher volume. But again, even the superficial, it'll depend on how many superficial lesions the patient has. Every patient's a little different. So it's really hard to sort of generalize that volume will be different for superficial versus deep, but then particularly at this point in the launch. Okay. Thank you. And our next question will be coming from the line of Rami O'Connor of Kempin, your line is open, Rami. Hi, team. Thank you so much for the presentation today and for my questions. I have two. So the first, of the 15-plus institutions that I've prescribed to UDRI-KEV, can you provide some color on what centers these actually represent? So are they predominantly the larger academic centers? Are you also seeing the adoption across more regional community centers? and how does that mix compare with your initial expectations? And then a second, maybe more broader question would be with the evolving treatment landscape in PD-1 refractive melanoma, I'm just curious to hear your view on how you think physicians are positioning to treat Kevin clinical practice. It might be too early to say, but are you seeing preference for immediate use or still post-checkpoint? Thank you. So, to your question around characterization of our initial treaters in the 15 accounts, these are mostly within our expectations. These are purposefully academic and hospital-based centers. We expected these to be the first adopters because these are institutions that have intratumoral experience. They may have been involved in our clinical trials. They have IR on board, they're comfortable with the miscellaneous J-code. So as expected, the majority of these accounts are those, and they tend to be sort of the higher volume melanoma centers in the country. So as I expected, a lot of these account are from that group, but what has been surprising is there are a few that are from the more regional centers that have adopted very, very quickly and very successfully to use Tudor Kev in both superficial and deep injections. So we're excited about that progress. And we're continuing to see, beyond the 15, we're continuing to the early adopter accounts or the priority one accounts continue to accelerate and momentum build in terms of them working through their processes, identifying patients, and we expect to see even more continue to come on board in the next weeks and months. In terms of your question on the treatment landscape and how we are seeing sort of a tutor care already being positioned, you are right. It's a little too early, but as a reminder, we have a really broad label that allows patients to be treated on progression of whatever PD-1-based treatment they were on before. That includes patients from the adjuvant setting, front line, second line, et cetera. So we would very much expect physicians, and what we're hearing is they're willing to use it early as well as, in some cases, later line patients depending on what the need is at the time. Super clear, thank you. And I would now like to hand the conference back to Sasho for closing remarks. Thank you, operator, and thank you all for your questions and for joining us today. Before we close, I just wanted to share a few final thoughts. We're very proud of what this team has accomplished, and we're excited about what is ahead. To do care is approved with a broad, practical label, and physician enthusiasm is evident. Early adoption has been very encouraging. The commercial launch of Tudor Kev is our number one priority, and we are focused on bringing Tudors Kev to a broad range of patients in need. Our revealed study of RP2 in uveal melanoma, as well as our confirmatory melanoma study, I3, which is now open to additional sites in Europe, are both enrolling very well. We look forward to sharing updates on these studies and our pipeline at upcoming investor conferences. Thank you for your time. And this concludes today's program. Thank you. Thank you all for participating. You may now disconnect. Thank you.