Viridian Therapeutics, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

Thanks. Thanks for having us.

Yeah. Sure. We are two months into the Lumvoa IV launch, which is great. All systems go there. I am sure we will get into more details as to what we are looking for there. We are preparing our BLA submission for our sub-Q program, elegrobart for thyroid eye disease. We expect to submit that BLA for our sub-Q program, in the first quarter of 2027, so right around the corner now. We have a TSHR program, a TSHR antagonist that we are expecting to submit the IND and get into the clinic. IND will go in this year, Q4. We will get into the clinic early next year. That is an exciting program with applicability in both thyroid eye disease and with Graves' disease, and there is some overlap in those diseases in terms of population, so that is a good complementary part of the portfolio.

We also have FcRn data coming as well, so we have a half-life extended FcRn program that we are working through the first-in-human trials. We are going to collect that data, and we said we would come out and present it or disclose it and give our indication, our clinical development plans going forward, for the half-life extended program. We also have another program which is an Fc fragment, very similar to the VYVGART approach, where we have already characterized that data. That study is complete, so we know that data hit the IgG suppression thresholds that you would want to see, and that it was albumin sparing. So we decided we wanted to see how the half-life extended program played out in the first-in-human, and again, we will have that this year, and then we will be able to decide what to do going forward.

Excellent. That is great. That is the portfolio in a nutshell.

Yeah. Operationally we are doing very well. The teams are doing a great job, and that goes with the sales reps, it goes with medical affairs, patient access liaisons, which is basically a patient support services team, supply chain. All systems are clicking, and that's really important to see, and all the support teams that go with that. Operationally, very exciting to see. Our PDUFA date was June 30. We actually got approval on June 26, which has some advantages in terms of J-code, and I'm sure we'll get into that detail. But we had our Q2 earnings in mid-August, so we were about 6 weeks into launch at that point. We indicated there were 3 main categories that we're tracking to understand how well launch is going. First is field engagement. Are we getting access to the physicians that make up the core prescribing base?

We know from profiling that there are about 2,000 core prescribers that make up 80%-90% of all TEPEZZA scripts that are written today. Our strategy is to make sure that we're engaging with them, and trying to make sure that they're aware of our data and our new label. We did say in that Q2 earnings release that we had engaged with 95% of that 2,000 core prescriber group within 6 weeks after launch, so really good field execution. Great to see. That's a metric that's really important to us, and this is actually real engagement. This is not just sending emails. This is actually talking. Really important there. Second element is market access. We have to get out and make sure that we're talking to the payers and trying to get policy adoption for Lumvoa.

We have been doing payer research for a number of years. We did our pre-approval information exchange with payers starting in January, knowing that we had a June 30 PDUFA date. Those conversations were productive. Essentially the guidance that we got from payers at that time was for parity pricing. We could expect parity coverage. Just as a reminder, TEPEZZA roughly has 85% of covered lives today. It took them 5, 6 years to get there. But that's a great footprint for us to step into, particularly with the guidance that we got from payers. Now we're just simply working through those conversations in a post-approval setting. We did guide to parity pricing on our approval call.

Again, we're going to be able to step into that footprint of coverage. That's a second element that we're tracking for launch. Then finally, and obviously critically important, is demand. What kind of physician demand are we seeing? How's that translating into patient demand? We're obviously paying very close to that. What we said in the Q2 earnings release was that based on the patient enrollment forms that we were seeing, that we saw broad and actually deep demand, too. We were seeing physicians not only on the breadth side, but also seeing multiple scripts coming out of them. All of the three categories that we track, and there's tons of subparts that go underneath those, but they all look good.

Yeah. There's three key elements. This is the basis of our Breakthrough Therapy designation. We applied based on three elements. As you know, we got Breakthrough Therapy and Priority Review for Lumvoa. The application was based on rapid onset of treatment effect. We were seeing a majority of patients respond on their proptosis. Just as a reminder to folks in the audience that this disease primarily affects women in their 40s and 50s. Proptosis is a bulging of the eyes. It can be disfiguring. Then there's also an element of diplopia, which is double vision. Can't read, can't drive. It's very difficult to live your daily life with double vision. There's also elements of pain and friction and redness that come in the eye, too.