United Therapeutics Corp Wells Fargo 21st Annual Healthcare Conference

Sure, Ben. Glad to do so. United Therapeutics is right now at a major inflection point where we are rolling out 14 new products over the next few years that cumulatively will provide us, we believe, somewhere between $50 billion-$100 billion a year in pharma revenue, moving us to the very top tier of pharma companies. I'll maybe march through these new products, Ben, quickly. The first one that I think most people are aware is the NDA that we submitted a few months ago and now has its PDUFA timing, which is nebulized Tyvaso for idiopathic pulmonary fibrosis. In its pivotal trial, it produced far and away the best clinical trial data ever from any registration study for pulmonary fibrosis.

Coming right behind that is our development of that same product for progressive pulmonary fibrosis or PPF, which is a 3 times larger indication, and we just announced about a month ago or so that we had fully enrolled that study already. That is on its way for its 12-month endpoint measurement. Right behind those two products, we have our dry powder inhaler for both IPF and for PPF. Right behind those four products, and all of these coming at a very rapid clip of more than one new product introduction per year. We have a coughless product called Tyvaso DPI for both ILD, PPF, and IPF, and that product is a truly amazing one in terms of its convenience and its ability to get rid of the number one side effect that patients in these indications have.

Coming right behind that product is a once-daily inhalation product called ralinepag, which we are developing again in three different indications, ILD, IPF, and PPF. Right there, Ben, is 10 new products over the next few years, and there is even more. The one that I have to say, people often ask me which is my favorite. Probably my favorite is the Tresmi product for PH-COPD. This is a very debilitating condition. It is a small proportion of people with COPD for whom their pulmonary hypertension is all out of proportion, and they are the people with the severest disease and the rapid decline into fatality. Our coughless Tresmi for PH-COPD can address a market of somewhere between 400,000 and 800,000 patients in the U.S. alone.

Moving over to pulmonary hypertension, we already filed an NDA, have a PDUFA date for our ralinepag product, once-daily pill for pulmonary hypertension. Again, produced the best clinical trial data of any product in pulmonary hypertension ever. That one will be queued up for FDA approval in June of next year. Right on its heels, we have what we call triple ralinepag, which is that once-daily pill together with the two background medications we demonstrated as efficacy over PDE5 and ERA. That takes us up to 12 new products. Last but not least, we have two very exciting products to roll out on top of all of that. We have a treprostinil/iloprost combination product that can be used as a PRN, meaning that you just use this product as necessary during the course of the day.

It does not matter if your background therapy is one of our therapies or one of our competitor's therapies. This will be the first "rescue inhaler" for pulmonary hypertension. You add all of these 14 products up. You are looking at a half million patients with PH-COPD. You are looking at 400,000 patients with the pulmonary fibrosis type of conditions. Another 100,000 patients with the pulmonary hypertension conditions. So it is a million addressable patients. All million should be captured by one product or another. But even with a 50% capture rate, we are looking at $50 billion in pharmaceutical revenue over the next few years.

Wow. That is really the reason, Ben, that we are excited to announce at this Wells Fargo conference, that we have done an accelerated share repurchase with a half billion dollars, bringing up our total repurchases just in the past near term to upwards of $4 billion.

The reason for that is it just makes no sense to us at all that the company is at a market cap of around $20 billion when, based on produced clinical trial revenues, filed NDAs, best results in the industry, multiple moats in terms of intellectual property protection to the 2040s, composition of matter protection for ralinepag to the 2040s. We have a super clear, straight shot at $50 billion to $100 billion in pharmaceutical revenue.

I see the market evolving to a place where the physician will ask themself, "Do I want to slow my patient's rate of decline or do I want to provide them actual clinical improvement?" Only one product out of the 12, 13, 14, I have actually lost track of products approved in pulmonary hypertension, has shown in its phase III clinical trial data actual probability of having a clinical improvement, and that is this product we call ralinepag with a trade name, ralinepag. Furthermore, that product is the easiest to take, just one pill once a day. I think physicians are going to move their patients from whatever other therapies they are on into just one pill once a day to actually get a clinical improvement in their patients.

Now, some physicians will say, "Well, my patient has been on a background PDE5 or ERA for a long time." That is why right on the heels of ralinepag's approval, we plan to file for approval of what we call triple ralinepag, which is a single pill in which the ralinepag has been blended together in a very specific technical way with a PDE5 and an ERA, so you get three MOAs, endothelin receptor antagonist, phosphodiesterase 5 inhibition, and the super prostacyclin activity that ralinepag offers. One pill, once a day, three MOAs. I think more than 80% of all the PH patients are going to be on that certainly by the end of this decade.

That one, the NDA we filed for ralinepag, and we received an acceptance of filing from the FDA and a PDUFA date, best of my recollection, June 27th of next year. Then coming right on the heels of that would be a filing of ralinepag triple combination, and we think because the basic ralinepag would've already been approved, that we would have a rapid turnaround from the FDA on the ralinepag triple combination, not more than 12-24 months later. So well in time for those.