Post by ronw77077 on Sept 12, 2024 8:48:31 GMT -5
Between Sept. 4th and Sept. 10th MNKD has appeared at the Wells Fargo, Morgan Stanley and H.C. Wainwright Investor Conferences. During this time frame UTHR appeared at the Morgan Stanley and Wells Fargo conferences. Following are take-a-ways from CEO Castagna at MNKD and from UTHR re: TDPI and IPF.
MNKD
General
There is so much great news coming out in Q4
In Q4 we will have the Inhale 3 (pump comparison) 30-week data readout (done in over 20 sites) vs. the 17-week data readout presented at the ADA meeting
MNKD is self-funding now
Should be cash flow positive going forward (with possible exceptions)
MNKD is now focused on paying down debt/convertibles as it wants to reduce potential dilution from conversion of the convertibles
Expect Afrezza to be marketed in India next year
MNKD already has the structure in place to market both Nintedanib and Clofazimine, including specialty distribution, reimbursement support and patient training.
Clofazimine 101 (for NTM) [every 1,000 patients should generate $100 million in revenue]
Initially will market in a nebulized form since it is the fastest way to get the drug on the market.
The market size is 100,000 in the U.S. and 100,000 in Japan
There are no barriers in front of us.
Clofazimine should be launched in the next 5 years
The regimen will be once a day for 28 days followed by 2 months of no drug and then a second 28-day period of once a day.
There will be 2 dose courses; the U.S. trial kicked off June this year in the U.S. and in Japan next year
Six months is the primary endpoint
MNKD will go right to Phase 3
There are 180 patients enrolling at 30 sites in Japan and 50 U.S. sites
Our program reduces toxicity.
When we are 50% enrolled, we will reassess the study.
There is a lot of interest in Japan
We are working on different DPI level formulations and will select one shortly
Nintedanib 201(for IPF) (existing product Ofev has ~4 billion in annual sales)
We want a better result than Ofev
1 out of 2 people cannot tolerate the current drug side effects
Diarrhea is the worst reaction currently.
This is a high mortality disease
With efficacy of a lower dosage in which MNKD can reduce the G.I. effect, the product will have a home run
Nintedanib should go to the market in 2026
Phase 1 in humans this year with data to be revealed in Q4
Phase 1 could be a twice a day treatment
Phase 1 will give us confidence on tolerability
At the end of Phase 1MNKD will go to the FDA; the FDA is requiring 52-week endpoints, but MNKD is trying for 26-week endpoints or 36 weeks
So, phase 2 could be 16 weeks if the FDA requires it,
MNKD believes 1 trial should be enough to go to Phase 2
MNKD could share risk with a partner
Mike foresees Nintedanib as a core part of a coming combination treatment program such as with Bristol Myers or B-I
MNKD is meeting with KOLs
Pediatrics
Q4 – data readout will be a pivotal moment for MNKD
At that point we will have 75% of the patient data done.
Then the question is whether the FDA will let us file or if they will require us have another 6 months of data for the remaining 25%; either way we will file for in the first half of 2025. The FDA will then spend 10 months in review.
Goal is 30-40% of pediatrics market; each 10% will generate $150 million in revenue
annually
MNKD has hired a team for pediatrics
MNKD feels “very confident” about pediatrics’ success
UTHR
General
Generated $10-15 Million revenue per quarter last year and $15-20 million per quarter this year
UTHR’s total revenue growth in Q2 was 20%, including TDPI’s 25% growth in the quarter
UTHR believes there is a great opportunity which will continue
The PAH side of the business is stable and growing
Inventory is in great shape both at UTHR and MNKD
More capacity is coming online at the end of the year
PAH- ILD
They now have 15% penetration of the 30,000 PAH-ILD market with a lot of room to grow
On Jan. 1 a new commercial team was put in place to educate physicians
Patients with ILD may also get PAH; doctors can now treat both
They have doubled the number of prescribers
They continue to be encouraged
The PAH-ILD prescribers are 40% bigger than the PAH subscriber base
Once a patient is on TDPI for about 3 months they will typically continue it for 3 years
IPF
The U.S. market is 100,000 with Europe being about the same size
The upside for UTHR is a $1-$3 billion opportunity
If MNKD only gets 10% royalty that will be $100 million-$300 million
80% of patients with IPF die in 5 years
TDPI is actually improving lung function, a significant factor
The investment in IPF will be immaterial to the benefit from that market
IPF will be a phase 3 program with data readout in 2025
Teton 2 (outside the U.S.) data will read out before Teton 1(U.S.) but they will already have data from both when they file as 1 trial
MNKD
General
There is so much great news coming out in Q4
In Q4 we will have the Inhale 3 (pump comparison) 30-week data readout (done in over 20 sites) vs. the 17-week data readout presented at the ADA meeting
MNKD is self-funding now
Should be cash flow positive going forward (with possible exceptions)
MNKD is now focused on paying down debt/convertibles as it wants to reduce potential dilution from conversion of the convertibles
Expect Afrezza to be marketed in India next year
MNKD already has the structure in place to market both Nintedanib and Clofazimine, including specialty distribution, reimbursement support and patient training.
Clofazimine 101 (for NTM) [every 1,000 patients should generate $100 million in revenue]
Initially will market in a nebulized form since it is the fastest way to get the drug on the market.
The market size is 100,000 in the U.S. and 100,000 in Japan
There are no barriers in front of us.
Clofazimine should be launched in the next 5 years
The regimen will be once a day for 28 days followed by 2 months of no drug and then a second 28-day period of once a day.
There will be 2 dose courses; the U.S. trial kicked off June this year in the U.S. and in Japan next year
Six months is the primary endpoint
MNKD will go right to Phase 3
There are 180 patients enrolling at 30 sites in Japan and 50 U.S. sites
Our program reduces toxicity.
When we are 50% enrolled, we will reassess the study.
There is a lot of interest in Japan
We are working on different DPI level formulations and will select one shortly
Nintedanib 201(for IPF) (existing product Ofev has ~4 billion in annual sales)
We want a better result than Ofev
1 out of 2 people cannot tolerate the current drug side effects
Diarrhea is the worst reaction currently.
This is a high mortality disease
With efficacy of a lower dosage in which MNKD can reduce the G.I. effect, the product will have a home run
Nintedanib should go to the market in 2026
Phase 1 in humans this year with data to be revealed in Q4
Phase 1 could be a twice a day treatment
Phase 1 will give us confidence on tolerability
At the end of Phase 1MNKD will go to the FDA; the FDA is requiring 52-week endpoints, but MNKD is trying for 26-week endpoints or 36 weeks
So, phase 2 could be 16 weeks if the FDA requires it,
MNKD believes 1 trial should be enough to go to Phase 2
MNKD could share risk with a partner
Mike foresees Nintedanib as a core part of a coming combination treatment program such as with Bristol Myers or B-I
MNKD is meeting with KOLs
Pediatrics
Q4 – data readout will be a pivotal moment for MNKD
At that point we will have 75% of the patient data done.
Then the question is whether the FDA will let us file or if they will require us have another 6 months of data for the remaining 25%; either way we will file for in the first half of 2025. The FDA will then spend 10 months in review.
Goal is 30-40% of pediatrics market; each 10% will generate $150 million in revenue
annually
MNKD has hired a team for pediatrics
MNKD feels “very confident” about pediatrics’ success
UTHR
General
Generated $10-15 Million revenue per quarter last year and $15-20 million per quarter this year
UTHR’s total revenue growth in Q2 was 20%, including TDPI’s 25% growth in the quarter
UTHR believes there is a great opportunity which will continue
The PAH side of the business is stable and growing
Inventory is in great shape both at UTHR and MNKD
More capacity is coming online at the end of the year
PAH- ILD
They now have 15% penetration of the 30,000 PAH-ILD market with a lot of room to grow
On Jan. 1 a new commercial team was put in place to educate physicians
Patients with ILD may also get PAH; doctors can now treat both
They have doubled the number of prescribers
They continue to be encouraged
The PAH-ILD prescribers are 40% bigger than the PAH subscriber base
Once a patient is on TDPI for about 3 months they will typically continue it for 3 years
IPF
The U.S. market is 100,000 with Europe being about the same size
The upside for UTHR is a $1-$3 billion opportunity
If MNKD only gets 10% royalty that will be $100 million-$300 million
80% of patients with IPF die in 5 years
TDPI is actually improving lung function, a significant factor
The investment in IPF will be immaterial to the benefit from that market
IPF will be a phase 3 program with data readout in 2025
Teton 2 (outside the U.S.) data will read out before Teton 1(U.S.) but they will already have data from both when they file as 1 trial
