Good day, and thank you for standing by. Welcome to the Replimune 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 one one on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. I would now like to hand the conference over to your first speaker, Arleen Goldenberg, Head of Investor Relations. Please go ahead.
Thank you, operator, and good morning, everyone. Thank you for joining us for Replimune's earnings call following the launch of TUDRIQEV. Earlier today, we issued a press release reporting our financial results for the fiscal second quarter ended September 30th, 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 Chief 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 TUDRIQEV, 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 10-Q 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, Arleen, and thank you for joining us today. This is a defining moment for Replimune. TUDRIQEV is the first commercial product from our RPx platform. We are excited to now be delivering TUDRIQEV 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 TUDRIQEV to as many patients as possible. Michelle will provide more details in a few moments. Importantly, the TUDRIQEV 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 TUDRIQEV. 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 it over to our Chief Commercial Officer, Michelle.
Thank you, and good morning, everyone. I am thrilled to lead the launch efforts to bring TUDRIQEV to patients in need. In the first few weeks of TUDRIQEV 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 TUDRIQEV 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. TUDRIQEV 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. TUDRIQEV 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 TUDRIQEV 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
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 TUDRIQEV 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 TUDRIQEV. Next, we secure access and establish operations to support a positive experience for both the facility and patients. Accounts then order product, and patients are treated. Today, we are 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 TUDRIQEV and our team's ability to reach priority customers. Next, access. About 20 accounts have swiftly placed TUDRIQEV on formulary. Last, orders. As of Friday, over 15 institutions have written one or more TUDRIQEV 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 TUDRIQEV 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 TUDRIQEV to patients without delay.
We think these examples demonstrate the unmet need and the urgency that exists to adopt TUDRIQEV, and momentum continues to build each week. In terms of securing coverage, TUDRIQEV 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 TUDRIQEV 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 TUDRIQEV 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 2027, and 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 TUDRIQEV. ReplimuneConnect 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 week 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 TUDRIQEV into their practices.
We are very excited about the early days of bringing TUDRIQEV 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, Replimune 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 in 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 the 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 the 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 TUDRIQEV and continued funding of IGNYTE-3 and 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 TUDRIQEV 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 one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile our Q&A roster. Our first question will come from the line of Evan Seigerman of BMO Capital Markets. Your line is open.
Hi guys. Thank you so much for taking my question. As we think about the cadence of the launch and getting the large centers online, what are some of the gating factors that we should really be drilling down in our model? 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 should be thinking about as we model? Thank you so much.
Thank you, Evan, for the question. In terms of some of the gating factors, so far as we mentioned, the launch is going very well. We've really been surprised and pleased with the level of enthusiasm and the ability for customers to quickly get TUDRIQEV on 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 little 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 TUDRIQEV. 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? As we've stated, 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.
We're looking forward to, in November, several more of these facilities have TUDRIQEV 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, 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, TUDRIQEV treatment is based on a patient volume with about 1 mL 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 Bratzel of Piper Sandler. Allison, your line is open.
Hey, thanks. Good morning, and thanks for taking the questions. Just a couple from me. I think you talked about the number of institutions who have prescribed TUDRIQEV. Could you talk to maybe how many have actually administered a dose, and what is the typical time from prescription to first injection? Then among accounts maybe that have prescribed but not yet treated, what's the most common hold up, access, scheduling with interventional radiology or something else? Then last question, but just thinking about the average price per patient, just 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 IGNYTE and how representative IGNYTE is of the real-world population? Thank you.
Thank you, Allison. I know there's a number of questions there, so we'll try and break that down. Just as a reminder, though, TUDRIQEV 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, who will cover a couple of those topics in terms of prescriptions, et cetera, time to dosing, and any sort of hold ups that we've been seeing.
Yeah. Thank you. I think one of the features, as Sush had 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've 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 expediency because they have patients in mind and then treat that patient pretty quickly after getting those workflows in place. 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 are part of that workflow process, and that is really key and a priority for us is to ensure the oncologists and the interventional radiologists are making these plans together. We find that that is sort of the most seamless approach. As I said, there has been a lot of receptivity on the part of the interventional radiologists to fit this into their approach as well. A best practice of that is just being very planful. If we can schedule what they are finding, is if they can schedule the patient for their eight cycles with interventional radiology when appropriate, that is working best. We are seeing that be replicated in these other accounts.
I think there was a question on average price and sort of volume and whether that is going to be similar to IGNYTE. In general, Allison, I might just say it is a little too early to get into that. Obviously, that is something we are going to be monitoring as we have more data, but I will let Emily add any additional color to that.
Yeah, I think, the only thing that we are watching is we do believe that IGNYTE 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. As Michelle mentioned, we are seeing early adoption by interventional radiologists.
Yeah. In terms of hold ups, I would not say that there has been anything that has been a major hold up. These accounts just work at different paces and some have been able to move very quickly. Others have more sort of restricted, sort of guidance on when they have P&T, et cetera. So, it is not because the physicians within those practices are not eager to treat TUDRIQEV, it is just sometimes they just take a little longer. We have got examples of accounts where it said, "It is not on you guys. You provide us everything we need. It is really on us just to go through our process." They are very much committed to doing that. In terms of your first question on prescribing, all of those accounts have ordered and will be treating patients, and most of them have already treated patients.
Excellent. Thank you.
Our next question will be coming from the line of Daina Graybosch of Leerink Partners. Your line is open.
Hey, good morning. Thanks for the question. I got Bill on for Daina. This one from me. Of the 140-ish institutions you engaged in your initial 200 target, can you give us a breakdown of their readiness to start ordering and prescribing? What are 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 am 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 TUDRIQEV on formulary so there is access within the institution. Sometimes that can be bypassed, and we've seen that be bypassed because patients are in need. I think overarchingly in my experience and what we're seeing here is that when there is an unmet need, these physicians and these facilities will do what they need to to get the drug to patients. We're seeing 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 radiologists.
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. The bottleneck is 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 TUDRIQEV. We're also seeing accounts outside of this initial 200 that don't have experience or haven't had experience with TUDRIQEV that are sort of figuring out the process, and have successfully treated patients as well. So, as we had said, that gives confidence that this can be a therapy that can be adopted quite systematically.
Yeah. One thing to add maybe is 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. Again, haven't really seen any major hold ups. But as Michelle said, every account's a little different, and it just can take more time in some accounts versus others.
Got it. Thank you.
Our next question will be coming from the line of Anupam Rama of JP 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 sales force, where you are now, and 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 23 account management positions that are in place and an operational excellence team that is almost fully in place. 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 copacetic state for the sales force and the customer-facing team. I'm sorry, now your last part of the question.
Yeah. What else needs to be done in the next couple of weeks and months on the sales force to get it complete?
Yeah. Thank you. I think we're in good shape, and the team's just going to continue to execute in terms of driving breadth and depth in these accounts.
Yeah. I think, Anupam, there's really nothing on the sales force side right now beyond just completing the training, getting out to the accounts and customers, and completing the engagement with 200 accounts, which I think will happen quite rapidly. Then moving beyond that initial 200 to the next wave of accounts. But really on the sales force 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.
Our next question will come from the line of Roger Song of Jefferies. Roger, your line is open.
Great. Thanks for taking the question. A couple quick ones. One is, do you have some visibility regarding the patients are being treated and the candidates to be treated? They are superficial only patient or lesion patient or visceral mix? Also in terms of formulary, so when a 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 mL, or that is based on the tumor volume? Just lastly, when you launch, get approval, you have some rough timeline on the focus, six months for the early adopter and the next 9-12 months for the next wave, 450 accounts.
Just curious now you are thinking based on the experience you have, if 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.
Yeah. Just to take your first question, no, we are definitely seeing adoption of both superficial as well as image-guided injections. 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-guided injections. In these early few weeks, we are definitely seeing those image-guided injections already happening, which is, I think, encouraging, and it is something that we will continue to focus on. I will let Michelle talk about formulary. My only comment on formulary is a lot of it is actually dependent on the payer policies, and they have not restricted us in any way in terms of retreatment. So I would not expect the institutional formularies to be more restrictive than the payer formularies. But, Michelle, you can comment on that.
Yes, I think that is exactly right. So the short answer is no, we are not seeing any restrictions on formulary in terms of usage. All have been supportive of TUDRIQEV to label. I think importantly, as Sushil had said, we are very encouraged with how quickly published policies have been put in place, and these are really exactly to the TUDRIQEV label, supporting not only the eight cycles but retreatment as necessary. There are no volume restrictions in any of these published policies. In fact, some of the policies, it allows for doses up to 24 doses. So if the label is eight and then retreatment. But nothing on volume, which is obviously very encouraging. So your next question was around launch success, and yes, our priority in the first six months we have 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 U.S. 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, which just, I think, reflects the demand that is out there and the unmet need that is out there. We will continue to assess accelerating, moving into these sort of regional centers and then into the community as swiftly as possible.
But I think, Roger, as Michelle said, what is important for us is we do this right, and I think if we are 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. Certainly, if we are ready to accelerate into that next wave, given how good the early traction has been, we will certainly be able and ready to do that. But we will do it at the right time when we feel it is ready and that we have fully penetrated those 200 accounts.
Excellent. Thank you.
Our next question will be coming from Mubeen Mosaheb of Cantor. Your line is open.
Hey, good morning. This is Mubeen on for Li. 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 a superficial injection versus a deep injection. How does that affect the volume of treatment? Thank you.
I'm sorry, could you repeat the question on the I think I got the volume of, 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 IGNYTE, we have seen that when you do deep injections such as lung and liver, they tend to have a higher volume. 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 generalize that volume will be different for superficial versus deep, and in particular at this point in the launch.
Okay. Thank you.
Our next question will be coming from the line of Romy O'Connor of Kempen. Your line is open, Romy.
Hi, team. Thank you so much for the presentation today and for my questions. I have two. The first, of the 15 + institutions that have prescribed TUDRIQEV, can you provide some color on what centers these actually represent? Are they predominantly the larger academic centers? Are you also seeing the adoption across more regional community centers? How does that mix compare with your initial expectations? Then a second, maybe more broader question would be, with the evolving treatment landscape in PD-1 refractory melanoma, I'm just curious to hear your view on how you think physicians are positioning TUDRIQEV in clinical practice. It might be too early to say, but are you seeing preference for immediate use or still post-checkpoints? Thank you.
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. As expected, the majority of these accounts are those, and they tend to be sort of the higher volume melanoma centers in the country. As expected, a lot of these accounts 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 TUDRIQEV in both superficial and deep injections. We're excited about that progress.
We are continuing to see, beyond the 15, we are continuing to see 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 TUDRIQEV already being positioned, you are right. It is 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 are hearing is they are 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.
I would now like to hand the conference back to Sushil 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 are very proud of what this team has accomplished, and we are excited about what is ahead. TUDRIQEV is approved with a broad practical label, and physician enthusiasm is evident. Early adoption has been very encouraging. The commercial launch of TUDRIQEV is our number one priority, and we are focused on bringing TUDRIQEV to a broad range of patients in need. Our REVEAL study of RP2 in uveal melanoma, as well as our confirmatory melanoma study, IGNYTE-3, 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.
This concludes today's program. Thank you for participating. You may now disconnect.