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Post by sayhey24 on May 21, 2024 7:06:59 GMT -5
Rumor has it Johan Wäborg is a big fan of Proboards and is going to put Saxenda on his DPI. Too bad Johan is not MNKD's CEO. |
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Post by peppy on May 21, 2024 7:18:36 GMT -5
Rumor has it Johan Wäborg is a big fan of Proboards and is going to put Saxenda on his DPI. Too bad Johan is not MNKD's CEO. Sayhey, I see you were correct. I still do not understand the timing of this inhaled drug. GLP-1 is a one week injection. How often would it be inhaled? how long is the therapeutic effect of inhaled GLP-1? What is the benefit? "As a leading inhalation company, with a range of fully developed inhaler platforms and the competence to formulate pharmaceutical compounds into powders, we are in a perfect position to take a step into reformulation of selected high-value products in areas where inhalation can offer significant patient benefits. We are very excited to take this important step towards the development of a next generation of patient-friendly GLP-1 treatments with sustained efficacy”, says Johan Wäborg, CEO of Iconovo." |
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Post by sayhey24 on May 21, 2024 7:48:23 GMT -5
Rumor has it Johan Wäborg is a big fan of Proboards and is going to put Saxenda on his DPI. Too bad Johan is not MNKD's CEO. Sayhey, I see you were correct. I still do not understand the timing of this inhaled drug. GLP-1 is a one week injection. How often would it be inhaled? how long is the therapeutic effect of inhaled GLP-1? What is the benefit? "As a leading inhalation company, with a range of fully developed inhaler platforms and the competence to formulate pharmaceutical compounds into powders, we are in a perfect position to take a step into reformulation of selected high-value products in areas where inhalation can offer significant patient benefits. We are very excited to take this important step towards the development of a next generation of patient-friendly GLP-1 treatments with sustained efficacy”, says Johan Wäborg, CEO of Iconovo." Saxenda is a daily GLP1 analog not weekly. We would need to do some studies but I am assuming daily. Maybe twice daily if that provides benefit to reducing the nausea. The key is pricing. This will not get insurance. The advantage is it is coming off patent and our biggest cost would be the packaging and inhaler so if properly priced it would be a super blockbuster. Peter Richardson believed a number of side effects like nausea could be reduced by inhaling and if you are taking smaller amounts maybe other issues too but we would need studies to follow up on Peters work. A big one is Saxenda is the only approved GLP1 approved for kids. Another is I see this as a maintenance drug for those who lost a lot of weight on Ozempic but can't afford it or want a less severe weight loss alternative. The thing is we already have the patent. What we need is Johan. |
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limo
Researcher
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Post by limo on May 21, 2024 9:37:48 GMT -5
Sayhey, I see you were correct. I still do not understand the timing of this inhaled drug. GLP-1 is a one week injection. How often would it be inhaled? how long is the therapeutic effect of inhaled GLP-1? What is the benefit? "As a leading inhalation company, with a range of fully developed inhaler platforms and the competence to formulate pharmaceutical compounds into powders, we are in a perfect position to take a step into reformulation of selected high-value products in areas where inhalation can offer significant patient benefits. We are very excited to take this important step towards the development of a next generation of patient-friendly GLP-1 treatments with sustained efficacy”, says Johan Wäborg, CEO of Iconovo." Saxenda is a daily GLP1 analog not weekly. We would need to do some studies but I am assuming daily. Maybe twice daily if that provides benefit to reducing the nausea. The key is pricing. This will not get insurance. The advantage is it is coming off patent and our biggest cost would be the packaging and inhaler so if properly priced it would be a super blockbuster. Peter Richardson believed a number of side effects like nausea could be reduced by inhaling and if you are taking smaller amounts maybe other issues too but we would need studies to follow up on Peters work. A big one is Saxenda is the only approved GLP1 approved for kids. Another is I see this as a maintenance drug for those who lost a lot of weight on Ozempic but can't afford it or want a less severe weight loss alternative. The thing is we already have the patent. What we need is Johan. i think it would work well in the T2D mkt, today NOVO NORDISK EXEC SAYS HAS SEEN PRECLINICAL, EARLY DATA FOR AMYCRETIN DRUG THAT MAKES CO "REALLY CONFIDENT" THAT THIS COULD BE THE NEXT BIG THING. thats their oral version. |
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Post by sayhey24 on May 21, 2024 11:31:23 GMT -5
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Post by ktim on May 21, 2024 16:47:35 GMT -5
Maybe we need to have a separate section of the board for "Things we wish MNKD were going to do that they won't"  |
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Post by prcgorman2 on May 21, 2024 16:55:30 GMT -5
I can't blame MannKind for wanting to focus on pipeline candidates which although are not blockbuster's in the wings, they appear to be potentially very profitable and orphan and therefore it can be hoped there is not a ton of competition from enormous BP behemoths.
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Post by castlerockchris on May 21, 2024 17:06:01 GMT -5
prcgorman2 - Not sure why you don't see anything in the pipeline as a blockbuster. Isn't a blockbuster drug defined as one billion in annual revenue? If MNKD 101 does everything they say it does... and the market is 200,000+ potential patients and growing, like they say it is... and the company will bring in $100,000,000 million in revenue for every 1,000 patients, like they say it will...how can it not be considered a potential blockbuster? It would take roughly 5% market share for MNKD 101 to bring in $1 billion in revenue (200,000 potential users X 5%= 10,000 users, that's 10 X $100mm). Or is it you don't believe MNKD can pull it off? Or do you not believe their math? Gonna look silly if I don't have my assumptions right. I have a great memory, it is just a little short! 
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Post by ktim on May 21, 2024 18:59:24 GMT -5
prcgorman2 - Not sure why you don't see anything in the pipeline as a blockbuster. Isn't a blockbuster drug defined as one billion in annual revenue? If MNKD 101 does everything they say it does... and the market is 200,000+ potential patients and growing, like they say it is... and the company will bring in $100,000,000 million in revenue for every 1,000 patients, like they say it will...how can it not be considered a potential blockbuster? It would take roughly 5% market share for MNKD 101 to bring in $1 billion in revenue (200,000 potential users X 5%= 10,000 users, that's 10 X $100mm). Or is it you don't believe MNKD can pull it off? Or do you not believe their math? Gonna look silly if I don't have my assumptions right. I have a great memory, it is just a little short! If you look at the revenue projections presented by MNKD for Clofazimine, it seems to be about $400M in 2030 and then pretty much flatten after that through the end of the projection period of 2032. They didn't present their math at how they arrive at that, but obviously their math is considerably different than yours. Though part of the math may be to reduce enough that there is little chance of it being overpromising. |
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Post by hellodolly on May 21, 2024 19:01:39 GMT -5
Paraphrasing - Mike said, (I think at RBC Healthcare or JPM), the decision has already been made by the Board to focus on the current pipeline, not spend the time, effort and energy outside the orphan lung disease space HOWEVER, they would not turn away from an opportunity if it were available at a fire sale.
My guess we won't see any GLP1 self-initiated efforts anytime soon unless, MNKD get's the call off the bench to come in and a new contract was offered that were too good to ignore, for the right terms...maybe similar to a UTHR deal...repurposing an already approved version of a GLP1.
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Post by prcgorman2 on May 22, 2024 6:19:55 GMT -5
prcgorman2 - Not sure why you don't see anything in the pipeline as a blockbuster. Isn't a blockbuster drug defined as one billion in annual revenue? If MNKD 101 does everything they say it does... and the market is 200,000+ potential patients and growing, like they say it is... and the company will bring in $100,000,000 million in revenue for every 1,000 patients, like they say it will...how can it not be considered a potential blockbuster? It would take roughly 5% market share for MNKD 101 to bring in $1 billion in revenue (200,000 potential users X 5%= 10,000 users, that's 10 X $100mm). Or is it you don't believe MNKD can pull it off? Or do you not believe their math? Gonna look silly if I don't have my assumptions right. I have a great memory, it is just a little short! If you look at the revenue projections presented by MNKD for Clofazimine, it seems to be about $400M in 2030 and then pretty much flatten after that through the end of the projection period of 2032. They didn't present their math at how they arrive at that, but obviously their math is considerably different than yours. Though part of the math may be to reduce enough that there is little chance of it being overpromising. Good comments both. Thank you. I agree with both of you. Yes, I agree the $100,000,000 per 1,000 patients is a “blockbuster” number in a market of 200K+. But the math is the problem. I am frankly shocked by those numbers. I think it was lennymnkd that reminded me an important assumption is insurance companies will be asked to pay (~$16,600 a month for six-months per patient?). It is even more than that per unit of dosage assuming the treatment regimen is alternating phases of dose and no dose. Just because I am shocked does not mean hospital insurance companies won’t pay. I do not know what is possible or customary. (Note: agedhippie is who suggested coverage may be via hospital insurance. I didn’t even know there was such a thing.) The awe filled bewilderment on my part is why I agree with what ktim said. The revenue projections and the apparent cost per unit of dose suggest very low penetration of the estimated quantity of patients. $400M equates to less than 4% of the patient population. I don’t want to assume less than 10% of the patient population can benefit from Clofazimine DPI. But I actually find it difficult to assume mega(?) blockbuster status (although I was unaware of $1B as a generally accepted definition of “blockbuster”). It isn’t that it isn’t possible so much as I am unable to imagine such success for such an apparently high-cost treatment. |
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Post by dpjerryb on May 22, 2024 7:00:02 GMT -5
NTM ie MAC is a re-emerging near chronic infection that adapts to antibiotic 18 mo treatments
Symptoms are chronic fatigue at the least
101 if as adv could be fast effective treatment
Do question 100k per treatment for two 30 day regimines?
But penetration above 5% seems likely given current treatment implies reoccurance
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Post by letitride on May 22, 2024 7:28:29 GMT -5
NTM ie MAC is a re-emerging near chronic infection that adapts to antibiotic 18 mo treatments Symptoms are chronic fatigue at the least 101 if as adv could be fast effective treatment Do question 100k per treatment for two 30 day regimines? But penetration above 5% seems likely given current treatment implies reoccurance Study completion 22 months past primary endpoint may reveal better effectiveness to current treatments. Time will tell one can hope. |
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Post by castlerockchris on May 22, 2024 12:41:42 GMT -5
A couple of points for clarification: - I should have mentioned that the $1billion annual being a blockbuster came from UTHR's conference call when Dr. M.R. said that Tyvaso had achieved $1billion in annual revenue and could now be considered a blockbuster drug.
- Dr. M.C. made it clear when sharing the stacked bar revenue graph that I believe many people are referring to for guidance that it was more a depiction than a projection and was intended to show how the pipeline would effect product mix revenue on proportionate basis. He was very clear it was not a projection.
- As for the price of 101, I can only assume (yes I know what they say about assuming), that MNKD has done their homework. It only takes keeping someone out of the hospital for a couple of days to justify spending $100,000 on a drug to cure them.
Again, I will stress, if what Dr. M.C. is claiming about MNKD 101 becomes reality at the end of the trial, I believe reaching 5,000 annual users in three years should not be a real stretch. The trail needs to prove out the efficacy. I am guessing that Dr. M.C. and the team (and possibly the FDA given the status they have assigned it) have seen something in the earlier trial's or lab testing data that is giving them the confidence with which they are speaking. Or at least that is my hope.My back of the napkin math, again caveated by the above "it does what it says it is going to do," 101 alone, has the potential to impact share price per the table below. The assumptions built into the model are- Total addressable universe 200,000 - static, stock price prior to approval $6.5, 30% bump upon approval, MNKD 101 has a 30% net margin contribution, 25X multiple (P/E) on net margin, available share float increases by 2.5mm per year. Revenue presented is the forward 12 month run rate. Share price does not include impact of Tyvaso DPI, Afrezza or V-go (hahaha) growth or any future drugs. Those all would be incremental.
| Mkt Penetration | Patients | Revenue RR
| Net Margin | Market Cap | Share Float | Share Price
| | Starting Price |
| | | | 1.77B | 272.5m | $6.5
| | Approval |
| | | | 2.4B | 275.0m
| $8.5 | EOY 1
| .5% | 1,000 | 100m | 30m | 3.12B | 277.5m
| $11.23 | | EOY 2 | 1.3% | 2,600 | 260m | 78m | 4.3B | 280.0m
| $15.41
| | EOY 3 | 2.5% | 5,000 | 500m | 150m | 6.1B | 282.5m | $21.65 | | EOY 4 | 4.5% | 9,000 | 900m | 270m | 9.1B | 285.0m | $31.99 | | EOY 5 | 6.5% | 13,000 | 1.3B | 390m | 12.1 | 287.5m | $42.14 |
Thoughts? |
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Post by ktim on May 22, 2024 14:13:30 GMT -5
castlerockchris, Though I suppose I was using that graph for "guidance" of my expectations, it is really an "outlook" (as it is labeled), which perhaps is a "projection" that is more of a "depiction" and less of an "estimate". My knowledge of financial terms doesn't extend to the nuances between those. Obviously numbers going out 8 years should be taken with a Tbsp of salt, a wedge of lime and a swig of tequila. Though for some reason this "depiction" of a "projection" Mike chose to offer does show Clofazimine plateauing after the first 4 years of sales at a level around $400M. There must have been something behind depicting growth essentially stopping... market penetration saturation... competition and price erosion ?? Your illustration is a very titillating vision. However, I know some here would prefer you adjust the parameters so that share price is $100. Just a note, if share price increases like you show we'll be considerably over strike price of convertible debt at end of 2026, so you'd need to factor in the debt being converted on share count.
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