Post by Clement on May 14, 2024 10:57:55 GMT -5
from UTHR earnings call transcript for Q1 2023, Rothblatt in the Q&A:
"So Jess, we are pretty bullish on our forecast for Tyvaso DPI and the maximum capacity of the MannKind facility up in Danbury, Connecticut, will be by the beginning of next year, will be for 25,000 DPI patients. So we'll be entering '24 with a capacity for 25,000 patients.
Now as I mentioned in my introductory remarks, our company's goals for the middle of the decade are 25 -- being able to treat 25,000 pulmonary hypertension patients. So if a large proportion of those 25,000 patients are on Tyvaso DPI, which is, I think, reasonable, then it would be like, well, where is the production capacity for the go big on pulmonary fibrosis, whereas the production capacity for what we think the pulmonary fibrosis market will be.
Well, best as we can tell, we expect the pulmonary fibrosis market to actually be for Tyvaso DPI even larger than the pulmonary hypertension market. So we would need more than an additional 25,000 patient capacity for the pulmonary fibrosis market and indeed, the market research and the disease-modifying hypotheses that we have for Tyvaso DPI in pulmonary fibrosis is such that we could easily expect to have 50,000 pulmonary fibrosis patients being treated in addition to the 25,000 mid-decade pulmonary hypertension patients. So that's the reason why we need to start now deploying a substantial amount of capital to build this brand-new Tyvaso DPI production facility in Research Clinical Park, North Carolina.
As Mike mentioned, even that facility, even though its launch capacity will be 50,000 patients, it will have a surge capacity to go up to 75,000 patients. So we think between the 25,000 at MannKind, the 50,000 in North Carolina, the surge to 75,000 in North Carolina, as we enter the 2026 time frame, we then have a capacity to support 75,000 to 100,000 DPI patients which would cover our needs for both Group I pulmonary hypertension, Group III pulmonary hypertension, idiopathic pulmonary fibrosis and additional forms of pulmonary fibrosis that go under the rubric of proliferative -- progressive pulmonary fibrosis, which in fact, we are embarking on the other additional Phase III trial for."
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"So Jess, we are pretty bullish on our forecast for Tyvaso DPI and the maximum capacity of the MannKind facility up in Danbury, Connecticut, will be by the beginning of next year, will be for 25,000 DPI patients. So we'll be entering '24 with a capacity for 25,000 patients.
Now as I mentioned in my introductory remarks, our company's goals for the middle of the decade are 25 -- being able to treat 25,000 pulmonary hypertension patients. So if a large proportion of those 25,000 patients are on Tyvaso DPI, which is, I think, reasonable, then it would be like, well, where is the production capacity for the go big on pulmonary fibrosis, whereas the production capacity for what we think the pulmonary fibrosis market will be.
Well, best as we can tell, we expect the pulmonary fibrosis market to actually be for Tyvaso DPI even larger than the pulmonary hypertension market. So we would need more than an additional 25,000 patient capacity for the pulmonary fibrosis market and indeed, the market research and the disease-modifying hypotheses that we have for Tyvaso DPI in pulmonary fibrosis is such that we could easily expect to have 50,000 pulmonary fibrosis patients being treated in addition to the 25,000 mid-decade pulmonary hypertension patients. So that's the reason why we need to start now deploying a substantial amount of capital to build this brand-new Tyvaso DPI production facility in Research Clinical Park, North Carolina.
As Mike mentioned, even that facility, even though its launch capacity will be 50,000 patients, it will have a surge capacity to go up to 75,000 patients. So we think between the 25,000 at MannKind, the 50,000 in North Carolina, the surge to 75,000 in North Carolina, as we enter the 2026 time frame, we then have a capacity to support 75,000 to 100,000 DPI patients which would cover our needs for both Group I pulmonary hypertension, Group III pulmonary hypertension, idiopathic pulmonary fibrosis and additional forms of pulmonary fibrosis that go under the rubric of proliferative -- progressive pulmonary fibrosis, which in fact, we are embarking on the other additional Phase III trial for."
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