Replimune Group, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah. We are at a very exciting stage for Replimune. We are now a commercial stage company. Got our first FDA approval of TUDRIQEV, now known as TujuCare, in combination with nivolumab for unresectable advanced melanoma patients who progress on a PD1-containing regimen. We are very excited about that, and now we are very much geared up to getting that product in channel into patients. And we previously guided, after the August 6th approval, that within 60 days we should have product to patients, and we are still tracking very much to that timeline.

Yeah. We are right on track. After the approval, we had product, and now we have product approved for release.

That's triggered a number of things. We have API printed, and we're doing the artwork, packaging, and serialization, working with our 3PL to make sure that we can then ship the product to customers. The other aspect of it is just making sure that we build the commercial infrastructure so that we can get this to patients. On that front, we announced in August Michelle Donathalie is our Chief Commercial Officer, so she's been on board, getting up to speed with the team and the plans. The other aspect is that we're now just really re-hiring the team. We've hired about 70% of the team already, and should have the full commercial team in place by the time product is in channel. We already have reps out there talking to customers and making them aware of the product.

Obviously, there was high awareness already, but they're also focusing on making sure the operationalization happens in a very quick fashion once we get product to the end user.

There really isn't- To- too much there.

It's really just around training and onboarding.

About a third of the commercial team was actually previously at Replimune, so we brought them back. So that's been really good because they already have very Yeah good familiarity with the product, the customers, what we need to do from the workflow perspective to get this to patients.

So that's been really helpful, and they've been helping onboard the new people coming on board. So it's really just sort of getting them trained and getting them out in front of customers. Now waiting to get the product to the customers so that we can get it to patients.

Yeah. The number one factor for us is to have a positive customer and patient experience.

It's not about, for us that means being very deliberate in our launch and our approach. What we've done is we've taken a very targeted approach to doing this because we want to get it right. Because we believe if we get it right, that's going to lead to long-term sustainable growth and uptake of the product. By that, we've focused on these 200 target accounts. The reason we focused on these, what we call early adopter target accounts, is the hospital academic accounts that have all the infrastructure and experience to really uptake and onboard and utilize TUDRIQEV quickly. That means they've got interventional radiology there because we need to do these deep injections to maximize the patient opportunity. They have T-VEC experience. They've got prior RPx experience.