Can sales get to $450M to $500M in 2026?

[prcgorman2]

In the FY 2023 Forecast thread rickf asked: "It would be interesting to know how many folks on this board think that sales can get to $450 -$500M with a share price of $21 - $35 by 2026. My thoughts (based only on gut feel and the history of the company) is that there is no way we get there by 2026. What does everyone else think?"

[Clement]

When rickf asked the question, I thought he meant what is the annual run rate at end of 2026 (4 x Q42026).  Now that I re-read the quote above, I wonder if he is asking about the annual run rate at end of 2025.  Please clarify.

[prcgorman2]

I assumed end of 2026, but rickf will have to clarify what he meant.

[rebby]

Definition is key here. By the start of 2026 (FY25), by the end of 2026 (FY26), or run rate by the end of ‘26 should be materially different.

[letitride]

The survey is in 2026 and yeah it can happen

[rickf]

Jan 23, 2024 12:30:36 GMT -5 prcgorman2 said:

I assumed end of 2026, but rickf will have to clarify what he meant.

Sorry all - I did mean at he end of 2026.

[prcgorman2]

21 of 35 voters are of the opinion MNKD revenue can reach $450M to $500M in 2026. Let’s hope it will be a case of under-promising and over-delivering!

[sayhey24]

I am not sure its about hope. Its about decisions and execution. MNKD has the greatest advance in diabetes care in 100+ years. It also has the greatest advance in GLP1 care patented. Its really up to Mike to get'er done.

Afrezza has 3 issues which need to be fixed
1. label
2. SoC
3. cost

Assuming the India results and Kids results are great - the label can be fixed. Additionally, some changes to the SoC should be able to be made but there will be great pushback and my concern is "inhaled insulin" will be put in parentheses as it was this year in the SoC. The solution to this is broad based use prior to 2026 through a pricing action. Depending on what the 2026 SoC says will dictate insurance coverage in 2027 which of course addresses the cost issue.

Mike just needs to make the right choices. There is no need for hope. Now, if you want to see the pps rocket lets announce the inhalable GLP1. Pfizer's pill is not looking great but put it on Technosphere and that would be huge. The great part is we filed for the patent last year. Getting a partner like UTHR for MNKD-101 is also needed.

[prcgorman2]

I think your 3 Afrezza issues follow from the 2 most important challenges: prescriber reluctance (because of a lack of clinical data), and insurer reluctance.

The clinical data and insurance underwriting have to be solved or your 1 and 2 are going to continue to languish. Your #3 is a complicated bit I don’t have time right now to elaborate on but I agree it is very important.

[sayhey24]

Cost is solved by insurance coverage by both Medicare and private. However afrezza will get neither until its properly represented in the SoC. My concern is even with great trial data it will be "suppressed" as we saw in the 2024 SoC when "inhaled insulin" was put in parentheses.

Bill from VDex suggested if afrezza had a large enough subscriber 25k-50k base the ADA would no longer be able to ignore/suppress it. I agree. The problem is getting to that base at its current price is not possible. As Sports has mentioned cost is an issue and VDex often has to go to the next best thing. Aged has posted one of the ADA's arguments why metformin should be subscribed 1st in the SoC - it's cheap.

[Thundersnow]

Jan 27, 2024 11:35:58 GMT -5 sayhey24 said:

Cost is solved by insurance coverage by both Medicare and private. However afrezza will get neither until its properly represented in the SoC. My concern is even with great trial data it will be "suppressed" as we saw in the 2024 SoC when "inhaled insulin" was put in parentheses.

Bill from VDex suggested if afrezza had a large enough subscriber 25k-50k base the ADA would no longer be able to ignore/suppress it. I agree. The problem is getting to that base at its current price is not possible. As Sports has mentioned cost is an issue and VDex often has to go to the next best thing. Aged has posted one of the ADA's arguments why metformin should be subscribed 1st in the SoC - it's cheap.

I doubt Mike will sacrifice margins especially if the NEW DATA is far superior.  The NEW DATA will be the BUILD IT AND THEY WILL COME.  Once PEDS is approved it will force the insurance companies to take notice.   Changing SOC is a monumental task and will take YEARS.  

OK SAYHEY...It's time to give up on your fantasy dream of an Inhalable GLP-1.  It's not going to happen. 

Also MNKD could get to $450M in Revenues by the EOY '26 but they can't do it alone.  They will need a Partner to roll out Afrezza for KIDS.  MNKD does not have the personnel nor the MUSCLE to MARKET AFREZZA.   

[sayhey24]

Jan 27, 2024 12:23:40 GMT -5 Thundersnow said:

Jan 27, 2024 11:35:58 GMT -5 sayhey24 said:

Cost is solved by insurance coverage by both Medicare and private. However afrezza will get neither until its properly represented in the SoC. My concern is even with great trial data it will be "suppressed" as we saw in the 2024 SoC when "inhaled insulin" was put in parentheses.

Bill from VDex suggested if afrezza had a large enough subscriber 25k-50k base the ADA would no longer be able to ignore/suppress it. I agree. The problem is getting to that base at its current price is not possible. As Sports has mentioned cost is an issue and VDex often has to go to the next best thing. Aged has posted one of the ADA's arguments why metformin should be subscribed 1st in the SoC - it's cheap.

I doubt Mike will sacrifice margins especially if the NEW DATA is far superior.  The NEW DATA will be the BUILD IT AND THEY WILL COME.  Once PEDS is approved it will force the insurance companies to take notice.   Changing SOC is a monumental task and will take YEARS.  

OK SAYHEY...It's time to give up on your fantasy dream of an Inhalable GLP-1.  It's not going to happen. 

Also MNKD could get to $450M in Revenues by the EOY '26 but they can't do it alone.  They will need a Partner to roll out Afrezza for KIDS.  MNKD does not have the personnel nor the MUSCLE to MARKET AFREZZA.   

The inhalable GLP1 fantasy is not a fantasy.  MNKD filed the patent for it last year.  Of course that was after me whining about it here on Proboards and Mike not being aware of the Phase 1 work done by Al Mann and Peter Richardson.  If it is a fantasy then it was Al Mann's fantasy but the Phase 1 results were just too good to ignore.  What has not been done is marry Technosphere with a proper GLP1 analog although its in the patent and very doable.  Lets just do the pilot with Victozia and if it doesn't work out I will give up on MNKD $100 pps.  Who expected 10 years ago GLP1s to explode in the diet community the way they have.

Now explain to me what BP is going to partner to sell afrezza?  There is no BP partnering as long as afrezza is marginalized.  As long as there is no insurance coverage, few kid's mom's will be able to afford it.  They may want to come and use it but with no insurance coverage they won't be able to afford the price of admission.   The last BP's mission (Sanofi) was to doom afrezza not to sell afrezza.  Day 1 they were suppose to start the large scale trials and they did none.  They were suppose to fix the label - nope, it did not happen.  They were suppose to get it in the SoC - nope again.

What margins would Mike be sacrificing?  Scripts have been sub-1k for how many years now?  When something ain't selling the margins are the last thing to worry about.  Lets get some sales and grow the base and then we can talk margins.  For now Tyvaso DPI is paying the bills.  If we want to save some money we can put V-Go back in the dumpster instead of now worrying about it being destructive to our key accounts - again predicted here on Proboards.

Now - here is an interesting statement by Al Mann.  He knew they could make afrezza for cheap even though it has been premium priced.  The newer "antiglycemic agents" he mentions are the SGLT2 and GLP1s.  Without a significant price action until afrezza is step 2 in the SoC, its not going anywhere.  Heck, VDex can't even provide it for all their patients because its too damn expensive.  They need to use the "next best thing".

From Al - 
"Another issue is that many of the newer, more advanced antiglycemic agents are very expensive. If only there were a physiologic ultra-fast-acting insulin that would reduce postprandial hyperglycemia to within normal guidelines without the risk of hypoglycemia or weight gain and without the complexity of titration or the need for multiple daily measurements of glucose. Such a prandial insulin would far better deal with postprandial excursions throughout the entire spectrum of diabetes. Moreover, key opinion leaders assert that, by reducing pancreatic and hepatic stress, such an insulin would slow and perhaps even stop progression of Type 2 diabetes and prediabetes. Surely, that would seem to offer a far better solution than those alternative drugs. Moreover, a therapy that does not require the inconvenience and discomfort of multiple daily injections, would certainly be more patient-friendly"

[ktim]

It sure doesn't seem from the projected revenue to 2032 that Mike is expecting some paradigm shift based on peds or India trial (at least he's not wanting to be judged against that). Incremental increase in revenue, yes, but doesn't seem anticipation of significant change in insurance coverage or SoC (beyond adding kids to the label).

[MnkdWASmyRtrmntPlan]

2022 revenue was $100 million.
2023 revenue consensus is $194 million
So, 2023 will be almost double 2022's revenue, which is considering a half-year of Martine's T-DPI income gift.

Getting to 450 million is 2.3 times $194 million, which is annual growth of .524 per year, which may not be too much of a stretch of the imagination. I'm sure there are others here that have a better handle than I do on how much T-DPI growth is left including PAH and PH-ILD (and, is there a third indication?) and when the remaining indication(s) may come online generating revenue to get a better picture of 2026 revenue potential.

Of course, that revenue potential would only be driven by increased T-DPI (royalty & mfg) and Afrezza sales (I’m intentionally not mentioning V-go, which will be under $10M in 2023). The only other contributor might be MNKD 101 (Clofazimine), but my opinion is that, at the earliest, it may just start to be sold in Q4 2026. I welcome other opinions about that.

So, is it possible to get to $450,000,000 revenue per year by year-2026 with just 2 revenue sources? Sure. Is it likely? Well, that depends, as Sayhey said, on Mike, and he has not impressed me yet with the speed that he works.

So, that’s the revenue, but, getting from $3.35 to $21, let alone $35 per share, is another story. $21 would be a growth of over 6 times, which is just not realistic IMHO.

6-analyst consensus 1-year stock-price forecast at EOY 2024 is $6.67, and I don't recall Mannkind EVER! actually achieving their 1-year forecasted price.

As of Sept 30, 2023, there was over $273 Million in debt due by end of 2026. My impression is that much debt will take more than "some", "a few" or even "several" quarters to pay off, so it's going to be an epic journey before MNKD will be seeing another profitable quarter. Maybe not Hobbit/Lord of the Rings-type of Epic Journey, but certainly not by 2026.

I don’t know how much potential million$ MNKD 101 will be capable of generating, and we have yet to see Mike’s “one new pipeline candidate per year” even being thought about. I wouldn’t doubt if MNKD 201, 401 and 501 sit dormant in Pre-IND status until 101 is making money. I don’t think Mike likes to do two things at once. Perhaps he is not paid enough. Perhaps if he was paid more in dollars and less in shares he wouldn’t be such a red flashing stop-sign to new potential investors with his monthly million$ of shares sold in every month in 2023. Will that continue in 2024?  The best thing that could happen to MNKD is a new CEO. The CEO needs to start hiring new business recruits to work the upcoming pipeline before this company turns into an anchor.

Now, if anyone wants, I'll tell ya how I "REALLY"  feel.

[agedhippie]

Jan 27, 2024 19:29:39 GMT -5 ktim said:

It sure doesn't seem from the projected revenue to 2032 that Mike is expecting some paradigm shift based on peds or India trial (at least he's not wanting to be judged against that). Incremental increase in revenue, yes, but doesn't seem anticipation of significant change in insurance coverage or SoC (beyond adding kids to the label).

I would expect the pediatric approval to add about 40% to the Afrezza sales. The problem will be the insurance cover and the bias to putting kids on pumps. The pediatric group is 4 - 18 years so a 14 year range. The adult group is 18 upwards giving three times the population. The result is that to match the adult revenue you need three times as many kids on Afrezza to match the revenue Mike shared in that chart. In other words the chart actually is quite aggressive.