The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Martin, I wanted to start out talking about your goals for the year ahead. So maybe with that, you can outline some of the recent progress of United
Therapeutics. And then just share what you're looking forward to this year.
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. Maybe to now look farther ahead, I also wanted to spend some time talking about your 2025 goal, your 25 by '25 goal. So 25,000
patients is a locking number, clearly, one you see is achievable. I guess I want to understand how you accomplish that and what we envision the
business looking like when you do? So I guess, first, just thinking about the baseline where we are now, how many patients are on Tyvaso, Remodulin
and Orenitram today?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. So we talked about kind of the near term, talked about the long term a little bit. I want to drill down on Tyvaso. Now your largest
product after the very successful early start to the PH-ILD launch. I guess, first, you've talked about adding these 3,000 patients by the end of '22.
Can you tell us how many patients were added in the fourth quarter? And just to confirm, do you still expect to meet that 3,000 patient add target?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. And I guess related to that, can you walk us through where things stand with CMS reimbursement for Tyvaso in PH-ILD? And tell us
maybe how you plan to communicate that to investors once it's received?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And to the extent you have some government pay patients currently receiving free Tyvaso, when could they start being reimbursed?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. And you've alluded a couple of times to maybe some anecdotal reports of warehousing dynamic where some physicians are waiting for
CMS reimbursement to kick in before going through the process of initiating a patient on Tyvaso. Can you elaborate a little bit on that?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Can you give us a breakdown of how you see the number of PAH versus PH-ILD patients currently on Tyvaso and how you think about that changing
over time?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. And how are you thinking about the Tyvaso franchise outside of the U.S.? What do you need to do to get approved in Europe? And
would you potentially pursue a partner?
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JANUARY 06, 2022 / 1:00PM, JPM.N - United Therapeutics Corp Fireside Chat Hosted By JPMorgan
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. And I think there were some headlines over the holidays on this, but what's the latest status of the Tyvaso litigation with Liquidia?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Maybe switching to Tyvaso, DPI. Can you talk about how you see sales of Tyvaso or that franchise evolving with the introduction of the DPI?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. Bit of a specific question, but now that you have resubmitted the NDA as of December, any inclination yet as to whether you expect FDA to
classify it as a Class I or Class II response?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And can you tell us if the resubmission was based on resolving the inspection with the third-party vendor? Or did you move that function they
were providing elsewhere in order to resubmit?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Right. We've just got an investor question popping up here that's relevant to this topic. Do you need any inspection at the facility that you moved
this function to?
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JANUARY 06, 2022 / 1:00PM, JPM.N - United Therapeutics Corp Fireside Chat Hosted By JPMorgan
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. Maybe last one on Tyvaso DPI. I'm curious how you think about emerging competition like Insmed's TPIP, which is early, but might have the
potential for less frequent dosing?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Makes sense. Maybe switching to the Remodulin franchise. What's the feedback you're hearing from physicians and patients using Remunity?
And Martine, at the beginning, you kind of alluded to full launch for Remunity this year. Can you just elaborate a little bit on what that means
relative to what was happening in '21?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And I guess looking ahead, understanding there's probably a mix of new patient starts and switches to Remunity, what makes someone
eligible or likely to be switched from Remodulin and its current form, current pump onto Remunity and then why?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Maybe it's a good time to turn to RemoPro. So what exactly is the status there? And how much larger the patient population do you think it could
capture compare to Remodulin.
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. Let me sticking with pipeline opportunities, you partially answered this one earlier, but can you just provide a status update on both the
TETON and PERFECT studies? Talk about how enrollment is going and when we could see data?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. Maybe one more question on the pipeline before we wrap up because we're running out of time here. For the PERFECT study, curious
how similar or different the PH that COPD patients get is from the PH that ILD patients get and whether the increased results read across to success
in PH COPD and why or maybe why not?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. So maybe just to wrap up, we kind of talked about near-term business opportunities, we talked about longer-term pipeline opportunities.
I was hoping you could tie it all together and talk about your long-term vision for the company and what we should be looking forward to?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. Well, we'll leave it there. So thank you so much, Martine and Michael and James and Dewey for joining us today, and Happy New Year,
everyone.
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