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Post by tarheelblue004 on Sept 12, 2023 13:32:36 GMT -5
Lots of posts from me today! I am on a 9-hour flight back to the U.S. from Italy and had a few thoughts I wanted to articulate when I had the time. Which is definitely now…
Based on UT’s goal of 25 by 25 (25k patients by the end of 2025), and the rapid uptake we’ve seen of Tyvaso DPI, here are some early thoughts on where we will be in 2.5 years. As always, this is just v1 to be updated as we learn more. I tried to use round numbers and avoid precision given how little precision we have for forecasts 2.5 years out. Feedback / other thoughts are always welcome.
In summary, by the end of FY25 I expect:
- Net Income: $1 / share
- Share Price: $40+
Rationale:
UT has mentioned on each quarterly CC that they are on track for their goal of 25k patients by 2025. I expect ~16k will be on a Tyvaso product, with 75% (~12k) on Tyvaso DPI. This would mean MNKD will do ~$350m per year in high-margin Tyvaso DPI revenue 2.5 years from now. We are already doing ~$125m in annualized Tyvaso DPI revenue, 1 year post launch. So by end of 2025 we would be doing $225m more than today, gaining ~ $1 / share in net income from the Tyvaso revenue stream. Let’s conservatively say the rest of MNKD just breaks even at the end of 2025 to keep this simple. At an industry multiple of 20x P/E, MNKD net income would result in a $20 share price. I think the PE ratio will be much higher, 40+, reflecting MNKD’s growth rate being much higher than industry peers. This would put the share price above $40 by the end of FY25.
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Post by Thundersnow on Sept 12, 2023 14:20:37 GMT -5
Lots of posts from me today! I am on a 9-hour flight back to the U.S. from Italy and had a few thoughts I wanted to articulate when I had the time. Which is definitely now… Based on UT’s goal of 25 by 25 (25k patients by the end of 2025), and the rapid uptake we’ve seen of Tyvaso DPI, here are some early thoughts on where we will be in 2.5 years. As always, this is just v1 to be updated as we learn more. I tried to use round numbers and avoid precision given how little precision we have for forecasts 2.5 years out. Feedback / other thoughts are always welcome. In summary, by the end of FY25 I expect: - Net Income: $1 / share - Share Price: $40+ Rationale: UT has mentioned on each quarterly CC that they are on track for their goal of 25k patients by 2025. I expect ~16k will be on Tyvaso and ~12k on Tyvaso DPI. This would mean MNKD will do ~$350m per year in high-margin Tyvaso DPI revenue 2.5 years from now. We are already doing ~$125m in annualized Tyvaso DPI revenue, 1 year post launch. So by end of 2025 we would be doing $225m more than today, gaining ~ $1 / share in net income from the Tyvaso revenue stream. Let’s conservatively say the rest of MNKD just breaks even at the end of 2025 to keep this simple. At an industry multiple of 20x P/E, MNKD net income would result in a $20 share price. I think the PE ratio will be much higher, 40+, reflecting MNKD’s growth rate being much higher than industry peers. This would put the share price above $40 by the end of FY25. Glad you had time to evaluate but after UTHRs investor presentation the CFO said they are about done in converting Tyvaso patients to DPI so I would say Tyvaso users will be ~10K and DPI users ~15K+ which will raise your estimates. The CFO did say there will always be patients on the nebulized Tyvaso. Tarheel clarified his numbers which included all of UTHRs products. I am in agreement $40 by YE25 is very possible. |
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Post by tarheelblue004 on Sept 12, 2023 14:34:02 GMT -5
Thanks Thundersnow! I have adjusted the text in the original post to make it clear, but I had meant to say that Tyvaso nebulizar + DPI = 16k patients, with DPI as 75% of that ~12k patients. The total 25k number includes all of UT’s drugs - Remodulin, Oremitran, Unituxin, Adcirca along with Tyvaso nebulizar + DPI. I am saying total patients on a Tyvaso product will “only” be 16k of the 25k patients, with the rest on these other 4 drugs. Definitely possible though that Tyvaso total patients goes even higher than 16k! |
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Post by ronw77077 on Sept 13, 2023 9:14:02 GMT -5
Tarheelblue – how bold of you, but perhaps not bold enough!
Let me start with several informative comments made during the 9/11 MNKD-Wainwright Conference, the 9/12 UTHR-Morgan Stanley Conference and the 9/13 MNKD-Morgan Stanley Conference. We have heard some these or similar comments before. They lead to observations about 2024 and 2025, though I will focus on 2025.
Wainwright conference – Mike Castagna
Every 10,000 patients on DPI are worth $250-$300 million to MNKD (including payments for manufacturing). We are well on track to hit 10,000 patients.
The pipeline gives the company the 10X opportunity.
Over the next 12-18 months we expect continued growth of patients.
The Clofazamine trial is expected to begin in Q2 2024. There will be a 13–15-month enrollment in both the U.S. and Japan.
Over the next 12-18 months MNKD will be known as an IPF (Idiopathic pulmonary Fibrosis) company.
Morgan Stanley - James Edgemond CFO UTHR
In 2024 MNKD will increase production to support 25,000 patients on an annual basis and those will come in next year.
The PAH-ILD market is about 30,000.
Tyvaso DPI is the only approved drug available to treat PAH-ILD.
PAH-ILD [patient growth] has a consistent trend continuing.
At the end of Q2 2023 UTHR had a “low double-digit penetration”. [If I assume 12%, that means ~3,600 patients]
UTHR has about one quarter of the PAH market. [Previously, UTHR said there were 50,000 patients in the U.S. with 30-35% being treated].
UTHR now has 9,000-10,000 PAH patients.
Over time PAH-ILD will have more patients then does PAH.
Conversion of patients from the Nebulizer to DPI has largely been completed.
The current split of 70/30 is expected to continue.
Each year UTHR’s sales are strongest between Q2 and Q3 due to seasonality in Q1 and Q4 attendant to insurance plan changes.
Morgan Stanley – Mike Castagna
MNKD is in the middle of a large plant expansion [$60 million cost funded by UTHR].
It should come on line early next year. [This will increase 2024 revenues significantly]
IPF could be 100,000 patients.
PEDS first launch will be in 2025. [Previously MNKD said that for every 10% share of the pediatric market (i.e., 4–17-year-olds), MNKD would get ~$150 million in net revenue].
Clofazamine will launch in Q2 2024 for clinical trials at 75 sites around the world including 25-30 in Japan.
Clofazamine has a “high probability of success”. [Previously MKND said the market was ~100,000 in the U.S. and ~100,000 in Japan. Every 1,000 patients on Clofazamine will generate $100 million in annual revenues to MNKD.]
70% of MNKD shareholders are institutions.
Now for some deductions:
Assume UTHR has 9,500 PAH patients. .
At a 70/30 split there are 6,650 patients receiving DPI.
If there are 3,600 with PAH-ILD (see above), I’ll guess that UTHR adds 10% of the PAH-ILD population each year or about 3,000 per year. By 2025 that would be about 10,000 from PAH-ILD alone.
Assuming modest growth of PAH patients from 6,650 to 8,000, we get to a total of 18,000 total patients receiving DPI by 2025.
Using $275 million (i.e., midpoint of $250-$300 million above) per 10,000 users equals $27,500 per user – and 18,000 users would yield $495 million to MNKD.
By 2025 Afrezza /V-Go revenues should conservatively be $80 million/year, Afrezza PEDS notwithstanding.
It also seems reasonable to expect some Clofazamine revenue by that time,
Excluding Clofazamine, PEDS increases and the ALL important IPF, the foregoing points to 2025 revenue approaching $600 million.
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Post by JEvans on Sept 13, 2023 15:17:00 GMT -5
Looks like PPS will fluctuate btw $3-$6 until 2025, then the big move comes. Nobody wants to miss that move!
Longs keep doing what you're doing, Shorts keep doing what you're doing.....
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Post by tarheelblue004 on Sept 13, 2023 16:08:17 GMT -5
JE, though we’re forecasting end of FY25 numbers it won’t be a big bang then. Each successive quarterly call will show growth towards these / the actual numbers.
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Post by MnkdWASmyRtrmntPlan on Sept 13, 2023 17:27:23 GMT -5
... Clofazamine has a “high probability of success”. [Previously MKND said the market was ~100,000 in the U.S. and ~100,000 in Japan. Every 1,000 patients on Clofazamine will generate $100 million in annual revenues to MNKD.] ...Hi Ronw, I love the optimism. I think that one scenario is a little too optimistic, though. 100,000 patients in both US and Japan is 200,000. If every 1,000 patients generated $100,000,000 in annual revenue, that would be $100,000 for each patient and the calculation would be 200 x $100,000,000 = $20,000,000,000 (AKA $20 Billion). Maybe I'm wrong, but that seems like a little too much to dream for. I think $100,000/year would be a little too much for that Rx. But, I hope I'm wrong. I don't feel so bad when insurance companies are footing the bill. |
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Post by JEvans on Sept 13, 2023 21:28:19 GMT -5
JE, though we’re forecasting end of FY25 numbers it won’t be a big bang then. Each successive quarterly call will show growth towards these / the actual numbers. Going off of MC statements during 9/12/23 MS conference call....2025 seems to be the year where many things will culminate ! As things get closer we'll know more fore sure, but like I said until then, Shorts be short and Longs be long....and like Deion Sanders and the Colorado Buffaloes, "We Coming"!!! |
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Post by ronw77077 on Sept 14, 2023 9:29:46 GMT -5
MNKD is myRetirement Plan - you make a great observation. Do note that it is not my optimism that is in question, it is Mike Castagna's. The statement appears on page 19 of the First Quarter earnings call on May 9, 2023, so it was not an offhand remark. Let us all hope it is close to actuality. For what it is worth, Mike used to say that every 10,000 DPI patients would garner $200-$240 million in revenue. He now says it will garner $250-$300 million. Perhaps he is being conservative in his Clofazimine numbers too  |
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Post by centralcoastinvestor on Sept 14, 2023 12:46:37 GMT -5
MNKD is myRetirement Plan - you make a great observation. Do note that it is not my optimism that is in question, it is Mike Castagna's. The statement appears on page 19 of the First Quarter earnings call on May 9, 2023, so it was not an offhand remark. Let us all hope it is close to actuality. For what it is worth, Mike used to say that every 10,000 DPI patients would garner $200-$240 million in revenue. He now says it will garner $250-$300 million. Perhaps he is being conservative in his Clofazimine numbers too In general, I think that it is wise for a CEO to be conservative in what they project. By conservative, I mean that they should provide projections that are lower than what they expect. Under promise and over deliver is the best approach. |
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Post by Thundersnow on Sept 14, 2023 13:38:12 GMT -5
Tarheelblue – how bold of you, but perhaps not bold enough! Let me start with several informative comments made during the 9/11 MNKD-Wainwright Conference, the 9/12 UTHR-Morgan Stanley Conference and the 9/13 MNKD-Morgan Stanley Conference. We have heard some these or similar comments before. They lead to observations about 2024 and 2025, though I will focus on 2025. Wainwright conference – Mike Castagna
Every 10,000 patients on DPI are worth $250-$300 million to MNKD (including payments for manufacturing). We are well on track to hit 10,000 patients. The pipeline gives the company the 10X opportunity. Over the next 12-18 months we expect continued growth of patients. The Clofazamine trial is expected to begin in Q2 2024. There will be a 13–15-month enrollment in both the U.S. and Japan. Over the next 12-18 months MNKD will be known as an IPF (Idiopathic pulmonary Fibrosis) company. Morgan Stanley - James Edgemond CFO UTHR
In 2024 MNKD will increase production to support 25,000 patients on an annual basis and those will come in next year. The PAH-ILD market is about 30,000. Tyvaso DPI is the only approved drug available to treat PAH-ILD. PAH-ILD [patient growth] has a consistent trend continuing. At the end of Q2 2023 UTHR had a “low double-digit penetration”. [If I assume 12%, that means ~3,600 patients] UTHR has about one quarter of the PAH market. [Previously, UTHR said there were 50,000 patients in the U.S. with 30-35% being treated]. UTHR now has 9,000-10,000 PAH patients. Over time PAH-ILD will have more patients then does PAH.
Conversion of patients from the Nebulizer to DPI has largely been completed. The current split of 70/30 is expected to continue. Each year UTHR’s sales are strongest between Q2 and Q3 due to seasonality in Q1 and Q4 attendant to insurance plan changes. Morgan Stanley – Mike Castagna
MNKD is in the middle of a large plant expansion [$60 million cost funded by UTHR]. It should come on line early next year. [This will increase 2024 revenues significantly]
IPF could be 100,000 patients. PEDS first launch will be in 2025. [Previously MNKD said that for every 10% share of the pediatric market (i.e., 4–17-year-olds), MNKD would get ~$150 million in net revenue]. Clofazamine will launch in Q2 2024 for clinical trials at 75 sites around the world including 25-30 in Japan. Clofazamine has a “high probability of success”. [Previously MKND said the market was ~100,000 in the U.S. and ~100,000 in Japan. Every 1,000 patients on Clofazamine will generate $100 million in annual revenues to MNKD.] 70% of MNKD shareholders are institutions. Now for some deductions:
Assume UTHR has 9,500 PAH patients. .
At a 70/30 split there are 6,650 patients receiving DPI.
If there are 3,600 with PAH-ILD (see above), I’ll guess that UTHR adds 10% of the PAH-ILD population each year or about 3,000 per year. By 2025 that would be about 10,000 from PAH-ILD alone.
Assuming modest growth of PAH patients from 6,650 to 8,000, we get to a total of 18,000 total patients receiving DPI by 2025.
Using $275 million (i.e., midpoint of $250-$300 million above) per 10,000 users equals $27,500 per user – and 18,000 users would yield $495 million to MNKD.
By 2025 Afrezza /V-Go revenues should conservatively be $80 million/year, Afrezza PEDS notwithstanding.
It also seems reasonable to expect some Clofazamine revenue by that time,
Excluding Clofazamine, PEDS increases and the ALL important IPF, the foregoing points to 2025 revenue approaching $600 million.
Excellent analysis!!! Do you have any stock price projections based upon your Revenue Estimates?? |
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Post by ronw77077 on Sept 14, 2023 16:10:15 GMT -5
Unfortunately I have spotted a math error in the numbers I put forth. Specifically, of the ~6,650 DPI users, if 3,600 are ILD patients then the number of non-ILD PAH patients total ~3,000. Therefore, ILD patients climb by 3,000/year to ~10,000 in 2025. But the remaining PAH users of ~3,000 would presumably grow at a rate of 1,000/year, meaning that group would number ~5,000 in 2025.
Below are the corrected deductions.
Now for some deductions:
Assume UTHR has 9,500 PAH patients. .
At a 70/30 split there are 6,650 patients receiving DPI.
If there are 3,600 with PAH-ILD (see above), I’ll guess that UTHR adds 10% of the PAH-ILD population each year or about 3,000 per year. By 2025 that would be about 10,000 from PAH-ILD alone.
Assuming modest growth of PAH patients from 3,000 to 5,000, we get to a total of 15,000 total patients receiving DPI by 2025.
Using $275 million (i.e., midpoint of $250-$300 million above) per 10,000 users equals $27,500 per user – and 15,000 users would yield $412 million to MNKD.
This is remarkably close to Tarheelblue's estimate of $350 million.
By 2025 Afrezza /V-Go revenues should conservatively be $80 million/year, Afrezza PEDS notwithstanding.
It also seems reasonable to expect some Clofazamine revenue by that time,
Excluding Clofazamine, PEDS increases and the ALL important IPF, the foregoing points to 2025 revenue approaching $500 million.
As to predicting stock price, I like Tarheelblue's approach.
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Post by tarheelblue004 on Sept 14, 2023 16:13:31 GMT -5
ronw, I really like how you break down Tyvaso DPI forecasts to the patient sub-population level. Kudos on the analyses.
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Post by sayhey24 on Sept 14, 2023 17:30:38 GMT -5
Lots of posts from me today! I am on a 9-hour flight back to the U.S. from Italy and had a few thoughts I wanted to articulate when I had the time. Which is definitely now… Based on UT’s goal of 25 by 25 (25k patients by the end of 2025), and the rapid uptake we’ve seen of Tyvaso DPI, here are some early thoughts on where we will be in 2.5 years. As always, this is just v1 to be updated as we learn more. I tried to use round numbers and avoid precision given how little precision we have for forecasts 2.5 years out. Feedback / other thoughts are always welcome. In summary, by the end of FY25 I expect: - Net Income: $1 / share - Share Price: $40+ Rationale: UT has mentioned on each quarterly CC that they are on track for their goal of 25k patients by 2025. I expect ~16k will be on a Tyvaso product, with 75% (~12k) on Tyvaso DPI. This would mean MNKD will do ~$350m per year in high-margin Tyvaso DPI revenue 2.5 years from now. We are already doing ~$125m in annualized Tyvaso DPI revenue, 1 year post launch. So by end of 2025 we would be doing $225m more than today, gaining ~ $1 / share in net income from the Tyvaso revenue stream. Let’s conservatively say the rest of MNKD just breaks even at the end of 2025 to keep this simple. At an industry multiple of 20x P/E, MNKD net income would result in a $20 share price. I think the PE ratio will be much higher, 40+, reflecting MNKD’s growth rate being much higher than industry peers. This would put the share price above $40 by the end of FY25. During the conference yesterday Mike mentioned about 10X-ing the pps. This was the first time I have heard him say that in public. He did not mention his timeframe. You just may be on the right track. |
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Post by cedafuntennis on Sept 14, 2023 19:19:02 GMT -5
So, at $600 and assuming a price to sales ratio of 4.2, that puts us at around $10 in 2025? This without any other income from anything else and no hype from announcements, developments, etc.
What do you guys think?
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