United Therapeutics Corporation (NASDAQ:UTHR) Q3 2023 Earnings Call Transcript

So to the extent that reimbursement challenges are a reason for using the nebulizer that might tilt things a little bit more towards DPI. But as I said in my opening comments, I continue to think that there’s going to be a role for nebulizer. I think what we have learned over the 25 years to 30 years that we’ve been in this space is that patients are very different and some react better to one delivery device over another and vice versa. And so, we’re just really happy that we have multiple options to offer patients. And at the end of the day we’re really, we’re kind of agnostic as to which device it is because either way they’re running United – the patients are benefiting from a United Therapeutics product.

Martine Rothblatt: Thank you so much, Mike. And Jess, thank you for the question. We’re at the end of the call. But we have time for just one last question. Operator, last question, please.

Operator: Thank you. Our final question today comes from Ash Verma with UBS. Please go ahead.

Ash Verma: Great. Congrats on the quarter. Thanks for taking our question. So I have two. On the manufacturing expansion for Tyvaso at your partner MannKind for the DPI that was up 2.5x in June. Is that now allowing you to fulfill the minimum contractual levels at your distributors, or would that level of supply only be fully enabled by the second production line that MannKind is building? That’s first. And I mean, there’s a lot of pipeline for Tyvaso, very excited about PPF, IPF, but just curious the timelines for the enrolling these studies are a little bit protracted. Is that primarily because of the heterogeneity of the disease or just curious if there is any other factor playing in that? Thanks.

Martine Rothblatt: Okay. Ash, thanks for that question or that compound question. So let’s have the first part of your question relating to manufacturing be answered by our Executive Vice President for Technical Operations, Pat Poisson. And when he’s done answering the first part of your question, the second part of your question relating to the timelines for enrollment in the pulmonary fibrosis studies that one will be answered by Dr. Leigh Peterson. Pat, can you go first?

Pat Poisson: Sure. Thanks, Martine. And thanks for the question. So the process improvements we implemented earlier this year will fulfill demand both near and midterm for Tyvaso DPI, longer term, as we see growth in ILD will certainly need the new equipment that is coming online in the first half of 2024. So as of right now we’re able to fulfill demand and maintain inventory levels at the SPs [ph] and we’ll be able to do so until the new equipment comes online. And then we’ll be well prepared for the future.

Martine Rothblatt: Thank you, Pat. Dr. Peterson?

Leigh Peterson: Yes. So thanks for the question on our TETON program. We actually haven’t increased our timeline. I mean, we’re still on target to finish enrollment of the TETON studies at the end of 2024. But you’re right, we have increased the sample size and we’re now targeting the enrollment of the 576 patients in each study. And the reason for that is you’re exactly right. You mentioned the variability of the disease and we do routine blinded data looks and that is what we saw there was some basically standard deviations of the FEC and the completers prompted us to just out of caution to increase the sample size to increase the chance of success. But again just because of the pace of enrollment into these studies, which is fairly rapid. We haven’t increased our overall timeline to enroll those additional patients.