United Therapeutics Corp Morgan Stanley 24th Annual Global Healthcare Conference

Thanks so much. Sure. Terence, thank you so much for inviting us here.

We appreciate it. It's great to have the opportunity to give some framing comments because this is a very unique point. No other point is like this quarter in United Therapeutics' entire history, because this is the quarter that we have gone ahead and inflected ourselves from being an orphan drug, pulmonary hypertension company, which was our history, developing great medicines, multiple great medicines for pulmonary hypertension and building ourselves up to a few billion USD a year in recurring revenue and inflecting ourselves into a pulmonary fibrosis company, that will be treating hundreds of thousands of patients with a best-in-class drug for idiopathic pulmonary fibrosis. We're pretty confident we'll soon show similar results in progressive pulmonary fibrosis, which is not an orphan disease.

On top of all of that, due to some new products that we've developed, such as our coughless Tresmi inhaler, we'll be launching studies next year into a form of COPD called COPD-PH, which can be uniquely treated by our drug and has a prevalence in the United States of 400,000 to 800,000 patients.

It's just amazing, Terence, I know you've been with us for quite a number of years, monitoring the company, to be at this point in time when you look behind you and you see, okay, you've gone from nothing to being the largest player in pulmonary hypertension, building up this several billion USD recurring revenue, and then looking forward and saying, "Oh my God, we're about to launch into becoming like a major bracket biotech company with something like $50 billion to $100 billion in pharma revenue, mostly in non-orphan indications," all based on clinical trial results that have been now submitted to the FDA and in the estimation of all of the experts, whether in PAH for our medicine, YUTREPIA, once daily pill for pulmonary hypertension, or in IPF for our medicine, nebulized Tyvaso.

In everyone's estimation, these are the best drugs in these 2 different diseases with the best clinical trial results that have ever been shown. It's a hell of a point to be giving you framing comments right now.

Yeah. I pinch myself, actually, because I remember when we were 5 people and now 2,000 people with 14 drugs in active development.

Sure. The $8 billion we see coming from all of our core business where we are continuing to grow in all of our legacy products like Remodulin, Orenitram, and Tyvaso. But especially in the newly launched projects, which include, first of all, nebulized Tyvaso for IPF. We've submitted that to the FDA. We've got our PDUFA dates. We're pretty confident of launching that product in the middle of next year. That product will be launched into an indication with 100,000 prevalence in the U.S. The only alternative drug that has been shown to give an improvement over some very old, very toxic medicines is a Boehringer Ingelheim drug called JASCAYD. We're really happy to see that medicine launched, but our medicine, nebulized Tyvaso, showed in two separate phase III well-controlled studies, dramatically greater improvement than JASCAYD.

When you break it down to how many years of life an average patient can expect, they would be able to expect multiple years more of life on nebulized Tyvaso than on any other product in the IPF space. So we certainly expect several of those billions of dollars a year to grow in IPF. In the meantime, Terence, we just fully enrolled another study in a much larger indication called PPF, and we fully enrolled this study, 700 patients. We'll have data about this time next year, and we feel very confident that our drug will work in that indication as well.

When you look at the combination of 100,000 patients in IPF, 300,000 patients in PPF, that's 400,000 patients, and that will take you far beyond the $8 billion revenue run to what we expect will be in the fibrotic-type conditions like this a $40 billion pharma revenue. That's the near term. As I mentioned briefly in the framing remarks, I'll just touch on very quickly. Other products that we are developing for the IPF market, including Tyvaso DPI, and CoughFree, Tresmi, and then once-daily Roledpi, we will be bringing those products in to further solidify our hold on the IPF and PPF market. So $40 billion is, it's of course a lot of money, but we have a straight shot at it. We have the clinical trial data for the base of it.

I should mention that the company has been able to successfully garner intellectual property protection for its fibrotic applications of its medicines out to the 2040s, and composition of matter, IP protection for ralinepag also to the 2040s.