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Post by rickf on Nov 14, 2023 15:34:27 GMT -5
MNKD 2024 and 2025With the Q3 disappointment and gnashing of teeth this is a good moment to look at 2024 and 2025. UT has reiterated multiple times its projection of a $4 billion run rate by the end of 2025. As an aside, at the UBS Biopharma conference call today, the MNKD speaker stated that what UT means is a quarter with $1 billion revenue. The question I am trying to solve is “What will TDPI revenues have to be to reach the $4 billion?” If we can figure that out, we can deduce royalties to MNKD, and in turn, total MNKD revenues. Below is a revenue projection model. Key to the numbers is: • UT’s actual revenues reported for Q3. • UT reported its year over year growth percentage for each drug as shown in the Table 1. Table 1 shows those growth percentages and applies them by product for 2024 and 2025. Note that using those growth percentages for the two years results in revenue of just over $3 billion ($3,057) in 2025, well below $4 billion. Tyvaso is the only product with significant growth potential. Table 2 instead applies growth rates of 50% and 25% to TDPI and Nebulizer, respectfully. The split assumed is approximately 2/3rd and 1/3rd . UT has said the split is in that range and is expected to continue. Those rates result in 2025 revenue of about $4 billion. The resulting royalties are $123 M and $185 M in 2024 and 2025, respectively. Table 3 has actual MNKD results for Q1-Q3 and estimated Q4 revenues. I use a WAG of $25 M for Q4 royalties. As shown, I assume that in in 2024 and 2025 Afrezza grows by 16%, V-Go is flat and Coll & Svcs grows by 6% each year. These numbers result in ~30% total revenue growth in both 2024 and 2025. When adding royalties and Coll & Svcs revenue the total revenues from UT are $175 M and $240 M. These are below the $250- $300 M per 10,000 users Mike C has stated; this suggests that either the percentage growth is understated, Mike C’s broad statement is high, or the user number has not yet reached 10,000. What is not included is any revenue from PEDS, IPF, or Clofazimine. Based on comments made, while PEDS and IPF may be approved by 12/2025 it is unlikely that revenues will be recognized in 2025. On the other hand, it seems quite likely that Clofazimine will generate revenue in 2025, perhaps even in 2024; I have no basis to assume what such amounts may be. The foregoing statements and numbers below posit many assumptions which should be questioned. I invite all of you to do so. If the projections are reasonable, we should all be pleased with a company able to report 30% annual top line growth.  This looks amazing -- any idea what it will do to the actual share price for 2024 and 2025? |
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rebby
Researcher
Posts: 59
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Post by rebby on Nov 14, 2023 19:05:25 GMT -5
Rickf - that’s the million dollar question!
While the revenue is expected to grow significantly over the next two years, Binder mentioned that our net income will be near break even for the next few quarters. Now, those dollars can be assumed that they are going to the pipeline to advance Afrezza, Clomifazine, NTM, etc., which should lead to additional revenue and profitability.
Amazon did this for years and saw their SP grow despite not having a profit, but their leadership team was successfully able to convey the vision that caused people to want to buy in. Eventually, those “early” investors were rewarded. MNKD is not Amazon, but the parallels are the same and it comes down to articulating the vision. I’ve said this after the Q3 ER, I believe we will be relatively flat for a few quarters and then we will pop…and if a couple of those opportunities hit, it could be magical!
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Post by peppy on Nov 14, 2023 19:27:06 GMT -5
Rickf - that’s the million dollar question! While the revenue is expected to grow significantly over the next two years, Binder mentioned that our net income will be near break even for the next few quarters. Now, those dollars can be assumed that they are going to the pipeline to advance Afrezza, Clomifazine, NTM, etc., which should lead to additional revenue and profitability. Amazon did this for years and saw their SP grow despite not having a profit, but their leadership team was successfully able to convey the vision that caused people to want to buy in. Eventually, those “early” investors were rewarded. MNKD is not Amazon, but the parallels are the same and it comes down to articulating the vision. I’ve said this after the Q3 ER, I believe we will be relatively flat for a few quarters and then we will pop…and if a couple of those opportunities hit, it could be magical! A bit off topic. I was thinking about this the other day, then it dawned on me while Amazon had no profit, the revenues must have been growing. ? |
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Post by cretin11 on Nov 14, 2023 21:32:59 GMT -5
rebby you said it, “their leadership team was successfully able to convey the vision that caused people to want to buy in.” Aye, there’s the rub.
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Post by longliner on Nov 14, 2023 21:39:33 GMT -5
rebby you said it, “their leadership team was successfully able to convey the vision that caused people to want to buy in.” Aye, there’s the rub. At least you have your cat |
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Post by cretin11 on Nov 14, 2023 22:16:26 GMT -5
rebby you said it, “their leadership team was successfully able to convey the vision that caused people to want to buy in.” Aye, there’s the rub. At least you have your cat You got that right, that and four bucks can buy a cup of coffee… or a share of MNKD and you get some change. Weehaw! Sorry, just kidding around, maybe been celebrating $4.20 a bit early… or is that too late? It’s so confusing, weehaw! |
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Post by longliner on Nov 15, 2023 1:11:18 GMT -5
At least you have your cat You got that right, that and four bucks can buy a cup of coffee… or a share of MNKD and you get some change. Weehaw! Sorry, just kidding around, maybe been celebrating $4.20 a bit early… or is that too late? It’s so confusing, weehaw! You're good. Don't let the little stuff get to you. Heck, you're a Missouri fan if I remember correctly (Grandpa). What a year! Georgia is really a powerhouse and may win it all, so no shame in that loss. PRC probably has it right, I took a break from this nonsense for a bit, and it was all good. You all were still here when I came back. Unless there's a buyout, we'll all still be around when you come back, if you take a break. If you don't take break, take a breath, there's a new opportunity every day. |
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Post by cretin11 on Nov 15, 2023 5:16:58 GMT -5
Been a great year for the Tigers, thanks for noticing! Any year beating Tenn by a fat margin is nice. Competing in the modern SEC is tough, not many easy weeks, this ain’t your father’s Big Eight conference!
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Post by dh4mizzou on Nov 15, 2023 6:59:02 GMT -5
cretin11, I was at the game, and it was one of the best atmosphere's since Henry Josie made that 57 yard TD run against TAMU to seal Mizzou's first SEC East title in 2013. youtu.be/sIbHJQGaqhMI was at that game too BTW. |
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Post by standup on Nov 15, 2023 9:00:43 GMT -5
Rickf - that’s the million dollar question! While the revenue is expected to grow significantly over the next two years, Binder mentioned that our net income will be near break even for the next few quarters. Now, those dollars can be assumed that they are going to the pipeline to advance Afrezza, Clomifazine, NTM, etc., which should lead to additional revenue and profitability. Amazon did this for years and saw their SP grow despite not having a profit, but their leadership team was successfully able to convey the vision that caused people to want to buy in. Eventually, those “early” investors were rewarded. MNKD is not Amazon, but the parallels are the same and it comes down to articulating the vision. I’ve said this after the Q3 ER, I believe we will be relatively flat for a few quarters and then we will pop…and if a couple of those opportunities hit, it could be magical! A bit off topic. I was thinking about this the other day, then it dawned on me while Amazon had no profit, the revenues must have been growing. ? While Amazon was losing money from a GAAP net income perspective they were generating significant cash flow from operations as their revenue continued to grow. |
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Post by ronw77077 on Nov 21, 2023 12:13:12 GMT -5
TIMELINES
Kudos to beardog on Nov. 13 for:
“Why do you feel Clofazimine may generate revenue in 2024? We haven't even done a Phase 3 trial on it. Does the trial take only a few weeks or something? Doesn't approval take about a year after submission?”
This raises several questions concerning timelines. I’d like to enlist the help of board members to pitch in since I have limited insights on the following. For each 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
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?
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
• As tarheelblue brilliantly recently asserted, the delimiting factor in sales has been production of T-DPI
• At the recent 11/8 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. 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?
6. Will MNKD earn royalties but not manufacturing cost reimbursement for RT production?
I’m always impressed by the breadth of knowledge of board participants. And I deeply appreciate the Board Administrators’ efforts in herding all of us cats.
I look forward to reading the collective comments.
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Post by Clement on Nov 21, 2023 12:50:54 GMT -5
Ron, I would like to add a question about clofazimine manufacturing. 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. Is MNKD now capable of producing sufficient amounts for trials?
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Post by Clement on Nov 21, 2023 13:01:28 GMT -5
TDPI question 4
"4. Does the foregoing suggest that MNKD will need to support IPF for some period (e.g., prior to the new factory producing)?"
I don't have a direct answer but during Q&A at the UTHR Q3 EC, Dr. Peterson said UTHR is talking to FDA about how much additional work (in addition to TETON trial) might have to do to allow TDPI to be sold for IPF. Note: TETON trial is being done with the nebulizer.
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Post by Clement on Nov 21, 2023 13:04:18 GMT -5
TDPI question 6.
"6. Will MNKD earn royalties but not manufacturing cost reimbursement for RT production?"
There was a recent comment from MNKD that answered this as yes. I will try to find the reference.
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