Replimune Group 2027 Q2 Earnings Call

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 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 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 DiNapoli.

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.