Roger Jeffs
Analyst · Jefferies
Thanks, Jason, and good morning, everyone. We're delighted to share our business results and clinical progress with you today. One year ago, we launched YUTREPIA and believed the medical community would find value in our differentiated approach to inhaled treprostinil. One year later, we have the answer. Physicians are prescribing it; patients are starting to switch to it and referrals and starts continue to accrue at a robust and sustained pace. As you saw in our numbers this morning, as of July 31, we have received approximately 5,900 unique patient prescriptions, started more than 5,000 patients on therapy and had more than 1,100 physicians write for the product. 30% of those physicians have prescribed to 5 or more patients. What's especially notable is where that growth is coming from. The overall inhaled prostacyclin market grew again this quarter from $573 million in Q1 to $607 million in Q2 or approximately 6%. And YUTREPIA's growth alone was larger than the growth of the entire category, even as we saw flat to declining use of oral infused and competing inhaled formulations. That tells us something important. Not only are the numbers of new starts for inhaled treprostinil growing, YUTREPIA has taken an ever-growing share of the total market for inhaled treprostinil. On a net revenue basis, YUTREPIA is approaching 30% of the entire inhaled market, a tremendous result just over a year into launch, especially as the market is growing in concert with YUTREPIA's growth. This implies the majority of new patient starts are coming to YUTREPIA. What matters more than the numbers is the impact we're seeing in patient lives. I spent my career in this field and have watched the delivery of prostacyclin move from complex IV and subcutaneous infusion to cumbersome nebulized therapy to intolerable oral formulations and now to inhaled dry powder delivery. Across that history, one simplistic but guiding principle has remained constant. Better tolerability enables higher dosing, higher dosing can drive greater efficacy and greater efficacy can support durable clinical benefit. The linchpin in this therapeutic chain is solving first and foremost for tolerability as the ability to drive dose and improve symptoms while minimizing both off and on-target adverse events is the holy grail. That's the lesson I've learned from my 30-plus years in the field, and to me, explains why YUTREPIA has had such broad adoption and early commercial success to date as it offers all of these attributes. This critical link between tolerability, dose and efficacy was beautifully demonstrated in our 24-week ASCENT study in PH-ILD patients. Specifically, progressively higher median doses of YUTREPIA at weeks 8, 16 and 24 was accompanied by progressive improvements in 6-minute walk distance of 21.5, 31.5 and 41 meters, respectively, without worsening cough scores. The only caveat is that YUTREPIA requires a 4 times daily dose regimen, which is why we are going from strength to strength and aggressively building on these same principles with twice daily L606, which we believe has the potential to raise the tolerability bar even further. As we've previously shown, in our 48-week open-label study, L606 patients titrated across a broad range while incurring a low burden of adverse events, most notably the lowest incidence of cough we are aware of in any study of an inhaled treprostinil formulation, and we were able to observe enduring clinical benefit as peak 6-minute walk improvements were preserved at trough, or said another way, throughout the dosing interval. These results are especially impressive when you consider that patients enrolled reflected the prevalent population in the U.S. and were on combinatory background standard of care. We are not aware of any other product in clinical development that has matched the dose range, tolerability and durability that we have already seen with L606. We believe YUTREPIA and L606 have significantly raised the bar that every current and future product in this space will be measured against. And it is with this confidence that we've stood up a thoughtful R&D plan to best elucidate the current and future uses of inhaled treprostinil across a wide array of indications. In fact, between YUTREPIA and L606, we now have 10 clinical studies either underway or planned to begin over the next 12 months. And as Mike will explain, we can confidently make these investments because of the cash flow that this business now generates. With that, I'll turn it over to Mike.