United Therapeutics Corp Bernstein Insights: Healthcare Leaders and Disruptors – 3rd Annual Healthcare Forum

Thank you so much for joining us today. We are real excited here from our Healthcare Leaders and Disruptors Conference. It is excellent to have such a great community be here to hear from what I would say are our healthcare leaders and disruptors, and we are here to talk to our next set from United Therapeutics. I have the pleasure to introduce Dr. Martine Rothblatt, founder and Chief Executive Officer, as well as James Edgemond, Chief Financial Officer. Before we get into Q&A, we are going to spend a couple minutes where both of them have some prepared remarks. I will turn it over to them.

Thanks so much, Jeffrey. Super happy to be here at the Bernstein Conference. United Therapeutics is poised right now for an exponential growth trajectory unlike anything that we have yet experienced and really unlike much that you can ever see in the biotechnology industry. We are right now in the middle of launching 14 significant products that will completely transform the revenue and profit profile of our company. Those 14 products are a nebulized form of Tyvaso for IPF and PPF. These are two different lung fibrotic diseases. The NDA for Tyvaso for IPF has already been accepted for filing by the FDA, with a PDUFA date coming up early next year. This drug in its phase III trials demonstrated the greatest improvement in patient outcome of any drug that had ever been tried or developed in pulmonary fibrosis.

Just a radical improvement in life expectancy for patients with pulmonary fibrosis. Drug launches number 3 and number 4 are our DPI Tyvaso, again for IPF and PPF. DPI Tyvaso is a product that is already approved and the number 1 product prescribed in PH-ILD, and this product will next be launched into the IPF and the PPF market so that patients in that huge 400,000 patient indication, 100,000 in IPF and 400,000 combined with PPF and IPF, will then have an option of either using nebulized Tyvaso or DPI Tyvaso. So those are product launches 1, 2, 3, and 4. Coming right on the heels of those launches, we plan to launch a new product called CoughLess Trezmi, and this product will be launched for ILD, IPF, and PPF.

This is a CoughLess inhaled product based on a soft mist inhaler, and the NDA for this product will be filed before the end of the year, and we expect to launch that product next year. So that is product 5, 6, and 7. We have got three new products beyond that called Once Daily Ralpi, and this is a brand-new molecule that has the best efficacy ever shown in pulmonary hypertension and even stronger anti-fibrotic activity than treprostinil in pulmonary fibrosis, plus a PK profile that allows you to use it just once a day. So this product will be developed for IPF and PPF as well as ILD. Those are products 8, 9, and 10. We feel that we have an amazing spectrum of products that can each address ever larger portions of the population with IPF, PPF, and even ILD.

Beyond those products, we have some other amazing products that are being very soon launched. The one that I think is most dramatic is ralinepag, a once-daily pill for pulmonary hypertension. This is something that this entire field has clamored for many years. We developed this product internally, and it has a strong IP protection out until the 2040s. Most significantly, it is the only drug ever tested in the pulmonary hypertension field that showed clinical improvement in the patients with pulmonary hypertension, not just slowing the rate of decline, which it certainly did that as well. This product has been submitted to the FDA. It has been given a PDUFA date of June 24th, I believe, of next year, and we expect it to become the number one product prescribed in pulmonary hypertension.

Right on the heels of that product, we have another product, which is a triple combo form of ralinepag, that is ralinepag plus the two most commonly prescribed oral drugs, a PDE5 inhibitor, and an ERA. That will make the patient's pill burden easier and again, just one pill once a day all formulated in there. On top of all of that, we have a development of our TRESMI product for a condition called COPD-PH. This is the 13th product I mentioned. This is an indication with 600,000 patients in the U.S., Jeffrey, not one single approved drug for that indication. These patients are hurting. We feel very confident that this new product, TRESMI, for COPD-PH, will be able to capture a lion's share of those 600,000 patients.

When you stack them with the 400,000 in the PF/IPF, you are looking at 1 million patients that we will be able to address over just the next handful of years. Last but not least, we have a 14th product in development, which is a rescue inhaler for PH, something the field has never had before. It is called ILO Tra. It is a combination of two different prostacyclin-type molecules. We are busy as can ever be, Jeffrey, and the amount of drug development, product development at United Therapeutics, I would say is more robust, certainly in the pulmonary space, than any other pharmaceutical company, any biotechnology company, and we look forward to exponential growth in revenues over the next few years.

Yeah. Counting all that money is our great CFO, James Edgemond.

Great. Thank you, Martine, and Jeff, thanks for having us again this year. As Martine talked about, we are poised right now for explosive growth going forward. A lot of questions that we've had this morning were really around use of capital for us. We try to be very good financial stewards, make thoughtful investments that grow the organization. One of those uses right now is we're repurchasing our shares. We think with this explosive growth on the horizon and where we see the value of the stock today is one of the best uses of capital that we are pursuing right now. We actually are in the market completing what the board authorized earlier this year, which was a $2 billion share repurchase authorization.

We are in the market because we believe at this point, based upon all the products Martine talked about, that this is a great use of capital at this time.

That's great. I mean, that was a lot of drug development that you just covered. I mean, It's a full-time job.

It's a full, I mean, 32 minutes. Way to get to the highlights of all of that. It's on me and it's on us to make sure that we dive into the details of what you just talked about for some select programs. I'm actually going to start with a question that you just asked me before we started. You asked me, "Is United Therapeutics a leader or a disruptor?" And I said, "From what I know, both." And it's because of the drug development that you've highlighted and because of the results you've had so far. I'm going to put this back to the two of you. What is your answer to that question?

My answer is we are a disruptor.

Okay. The reason for that is currently we sit with about a $20-something billion market cap, and it's really hard for me to consider that a leader in the pharmaceutical or even in the biotech area.