Post by ronw77077 on Dec 1, 2023 12:54:03 GMT -5
I recently put out a version of this under MNKD 2024 & 2025. After reflecting on Clements observation that even with IPF’s FDA approval using a nebulizer, there will need to be a further period before approval of T-DPI for IPF. With that in mind I think the timelines for revenue recognition expectations need be reassessed.
I’d like to solicit board members’ input. For each product I state what MNKD and/or UT has said, and then pose questions.
Colofazimine
May: Trials will begin in the fall (i.e., Q3 2023) at 70 sites
May: We have a great partner in Japan
Sept.: Phase 2/3 will start in Q2 for clinical trials at 75 sites around the world including 25-30 in Japan
There will be a 13–15-month enrollment in both the U.S. and Japan
The treatment regimen will be 28 days on, 56 days off and 28 days on - four times a year
MNKD expects just 1 trial will be needed to file for FDA approval
After the factory fire in Germany, the manufacturing of clofazimine was moved to Danbury. MC told us (at the UBS conference) that MNKD was manufacturing its first clofazimine on that day.
Questions:
1 How does a 13–15-month enrollment relate to trials starting in Q2?
2 When would the trial reasonably be completed?
3 How long should it take for FDA approval?
4 When can we expect sales to commence?
5 Do we still have a partner?
6 Is MNKD now capable of producing sufficient amounts for the trials? [Clement]
PEDS
Q1 2023: Trials are underway to treat 4-17 year olds
We should have a trial readout in the first half of 2024
Trials should be completed in 2024
PEDS will be filed with the FDA in 2025
PEDS first launch will be in 2025
Sept: MNKD just hired a new marketer to get us ready for PEDS next year
Both MNKD and JP Morgan asserted that every 10% of the pediatric market captured by MNKD would generate $150 M in revenues
Questions:
1 Do you believe there will be any meaningful sales to PEDs in 2025?
2 What is the size of the PEDS market?
T-DPI
The delimiting factor in sales has been production of T-DPI
At the Nov 8 UBS call they cogently stated demand is outstripping supply
Completion of the MNKD factory expansion in 4-6 months will have an immediate impact on sales
Per Mike C, it should come online “early next year”
Construction has begun in the Research Triangle, NC [RT}; it will take 2 years to build out the new factory
Then they will qualify it with the FDA
It will have the capacity to support 50,000 patients in the 2027 time frame and then be able to support an additional 25,000
The IPF Teton studies will be fully enrolled by 12/24
Data will be known at the end of 2025 (whatever that means)
Questions:
1 Does this imply that UT will not be able to seek IPF approval until 2026?
2 How long might factory approval take; is it like building a house with multiple inspections during construction and a short inspection upon completion?
3 Does product approval coincide with factory approval?
4 Does the foregoing suggest that MNKD will need to support IPF for some period (e.g., prior to the new factory producing)?
5 Dr. Peterson said UTHR is talking to FDA about how much additional work (in addition to TETON trial) might have to do to allow T-DPI to be sold for IPF. [Clement] Does this suggest that T-DPI for IPF should not be expected until 2027?
6 What will MNKD’s role be (i.e., will all of the processes be performed in RT or will MNKD continue to make the dry powder in Danbury?
7 Will MNKD earn royalties but not manufacturing cost reimbursement for RT production? Clement reports there was a recent comment from MNKD saying yes.
I look forward to reading the collective comments.
I’d like to solicit board members’ input. For each product I state what MNKD and/or UT has said, and then pose questions.
Colofazimine
May: Trials will begin in the fall (i.e., Q3 2023) at 70 sites
May: We have a great partner in Japan
Sept.: Phase 2/3 will start in Q2 for clinical trials at 75 sites around the world including 25-30 in Japan
There will be a 13–15-month enrollment in both the U.S. and Japan
The treatment regimen will be 28 days on, 56 days off and 28 days on - four times a year
MNKD expects just 1 trial will be needed to file for FDA approval
After the factory fire in Germany, the manufacturing of clofazimine was moved to Danbury. MC told us (at the UBS conference) that MNKD was manufacturing its first clofazimine on that day.
Questions:
1 How does a 13–15-month enrollment relate to trials starting in Q2?
2 When would the trial reasonably be completed?
3 How long should it take for FDA approval?
4 When can we expect sales to commence?
5 Do we still have a partner?
6 Is MNKD now capable of producing sufficient amounts for the trials? [Clement]
PEDS
Q1 2023: Trials are underway to treat 4-17 year olds
We should have a trial readout in the first half of 2024
Trials should be completed in 2024
PEDS will be filed with the FDA in 2025
PEDS first launch will be in 2025
Sept: MNKD just hired a new marketer to get us ready for PEDS next year
Both MNKD and JP Morgan asserted that every 10% of the pediatric market captured by MNKD would generate $150 M in revenues
Questions:
1 Do you believe there will be any meaningful sales to PEDs in 2025?
2 What is the size of the PEDS market?
T-DPI
The delimiting factor in sales has been production of T-DPI
At the Nov 8 UBS call they cogently stated demand is outstripping supply
Completion of the MNKD factory expansion in 4-6 months will have an immediate impact on sales
Per Mike C, it should come online “early next year”
Construction has begun in the Research Triangle, NC [RT}; it will take 2 years to build out the new factory
Then they will qualify it with the FDA
It will have the capacity to support 50,000 patients in the 2027 time frame and then be able to support an additional 25,000
The IPF Teton studies will be fully enrolled by 12/24
Data will be known at the end of 2025 (whatever that means)
Questions:
1 Does this imply that UT will not be able to seek IPF approval until 2026?
2 How long might factory approval take; is it like building a house with multiple inspections during construction and a short inspection upon completion?
3 Does product approval coincide with factory approval?
4 Does the foregoing suggest that MNKD will need to support IPF for some period (e.g., prior to the new factory producing)?
5 Dr. Peterson said UTHR is talking to FDA about how much additional work (in addition to TETON trial) might have to do to allow T-DPI to be sold for IPF. [Clement] Does this suggest that T-DPI for IPF should not be expected until 2027?
6 What will MNKD’s role be (i.e., will all of the processes be performed in RT or will MNKD continue to make the dry powder in Danbury?
7 Will MNKD earn royalties but not manufacturing cost reimbursement for RT production? Clement reports there was a recent comment from MNKD saying yes.
I look forward to reading the collective comments.
