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Post by peppy on Sept 16, 2021 16:19:08 GMT -5
MNKD volume at 1 hour of trade. real time, 645,313 summary, 1,012,354 Avg. Volume 2,984,431 4.5050. -0.1650. (-3.5332%) As of 10:30AM EDT. Market open. added, volume at 2 hours of trade, real time, 922,241 summary, 1,481,589 4.5100. -0.1600 (-3.4261%) As of 11:30AM EDT. Market open. MNKD Volume at the half day of trade. real time, 1,063,963 shares. Summary. 1,773,623 4.505. -0.165. (-3.5332%) As of 12:45PM EDT. Market open. MNKD Nasdaq real time volume, 2,092,710 shares. MNKD Nasdaq summary volume, 3,027,421 shares. $4.56. -0.11 (-2.36%) At close: 4:00PM EDT  |
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Post by Chris-C on Sept 16, 2021 16:19:30 GMT -5
So with last reported short interest on this board: Short Interest 8/13/21 : 31,380,956 My question is: With a pending FDA decision on Trep T, due in less than a month on October 15 as I understand it, that most people/investors seem to think will be positive given the previously announced results of the Phase 3 study by UTHR; Why are the shorts not exiting and why is the share price going down...? Does anyone else find it strange...? Oh I forgot this is Mannkind... GLTAL's!!!  I think the part about “most people/investors seem to think it will be positive” is key. If this is the expected outcome, there isn’t going to be any surprise. Large market movements happen when there are surprises (earnings blowout, partnerships, regulatory hits, etc.). Unlike most others here (shocking right?), I don’t think approval alone is going to spike the share price in a sustained manner. What will increase the share price is patient conversion to Tyvaso and sales, where the royalties kick in. In general, I agree. It's probably accurate that the regulars on this board are atypical in many respects with respect to the ownership of shares in MNKD. Observers here follow every nuance closely (sometimes, perhaps, too closely). There is no way for us to know how many of those 31 million shares held short are owned by funds and tutes, and how many of them are held as hedges that are meant as "security" and not related to expectations about the company. So much trading is determined by algorithms that simply look at statistics and patterns derived from what the stock has done and what it is doing, with a goal of predicting and exploiting expected trends. I will say that it surprises me that there are as many shares short as reported; but to the casual observer, looking at the SP today versus where it was a year ago, perhaps it makes sense (given MNKD's history) to bet that (absent big news) it moves down as long as the volume stays relatively low. It's good to remind ourselves that the benefits of an approved drug for UTHR to MNKD are indirect. The risk resides in UTHR. Unless the wheels fall off the wagon, worst case scenario for Tyvaso would be a delayed approval. That delays royalty and cost plus manufacturing payments to MNKD (which possibly increases profit for Afrezza by making the production facility more efficient.) Meantime, MNKD (hopefully) continues to work on other partnerships and continues to grow awareness of Afrezza. When revenues come in that indicate sustainable profit for MNKD, sentiment will change. The strength of that change will depend on growth in profit. In my mind, the next important milestone is a quarterly report that shows profit and not loss followed by additional quarterlies that show continuing growth in revenue and profit. As those days get nearer, I have to stop and remind myself not to get too far out ahead of my skis (as they say in Minnesota). This means that if I expect a big jump in share price in MNKD if the drug is approved, I could be disappointed. Time will tell. I do not agree with the notion that MNKD is "sunk" if the approval is delayed. I'm not sure anyone can reliably estimate how much of the current share price is explained by anticipation of revenue from that expected approval. GLTAL Chris C |
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Post by cretin11 on Sept 16, 2021 17:47:59 GMT -5
The school of thought that approval is mostly priced in makes sense. It’s no secret, and it seems highly likely to happen.
I haven’t seen any speculation that MNKD is sunk if approval is delayed, and that would be too extreme of a statement for anyone to reasonably make. However, if we do get delayed (or worse) then I’d expect us to take a significant hit in share price.
That being said, I still feel bullish about approval, just not expecting our share price to rocket up (a modest move up, yes). For a major move, we need revenues and profit. Oh, and perhaps guidance!
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Post by sportsrancho on Sept 16, 2021 18:10:43 GMT -5
I haven’t heard any sunk talk either.
My feeling is it is not priced it yet🤷🏼♀️ But I also know launches most of the time get shorted. So it will be a while between launch and profitability ..that may be why the high short count.
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Post by jkendra on Sept 16, 2021 18:55:58 GMT -5
LOL
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Post by cretin11 on Sept 16, 2021 23:18:05 GMT -5
I haven’t heard any sunk talk either. My feeling is it is not priced in yet🤷🏼♀️ But I also know launches most of the time get shorted. So it will be a while between launch and profitability ..that may be why the high short count. Yep, and that is the big question, is it priced in and/or to what extent. I hope you are right. Anyone holding calls needs that to be true. |
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Post by akemp3000 on Sept 17, 2021 5:16:58 GMT -5
It seems to me that if it were priced in, the average daily volumes would have been higher due to attention on the forthcoming decision whereas volumes have remained relatively low for quite some time. I do not know if such a correlation exists, just speculating.
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Post by prcgorman2 on Sept 17, 2021 6:58:50 GMT -5
The Priority Review Voucher is supposed to provide an approval (or not) within 8 months after FDA acceptance of the voucher which was in June. That means the FDA has until next February to provide a response.
The press release from UTHR in June is what set the expectation that the FDA would be able to provide a response in October. Reading it again, the information in the press release was specific enough that I have to assume that the media/legal teams at FDA and UTHR collaborated on the UTHR press release. I think that’s where the confidence in the October timeframe comes from.
Even so, sometimes what looks doable in June with an expected result in October takes longer. Knowing corporations and the government, I won’t be surprised if October comes and goes and there is no announcement. And, I think the SP action may reflect I am not the only one who isn’t betting on an October announcement.
As for post-approval (if that happens), I do expect a pretty sharp jump in SP, followed by a re-trace to a higher floor than what we have now. And, I agree with Awesomo that it is business fundamentals that will raise the floor over time. My wild ass guess is the new floor will be between 6 and 8. And it is only a guess (although I told my wife 8 so I’ll almost certainly be wrong on that number).
I am unconcerned about the current price movement. We are solidly in the $4s. Some of that is expectations around approval of UTHR’s Tyvaso DPI, and some of that is from business fundamentals in terms of executing on the UTHR agreement (i.e., milestones) and on the improved debt financing.
I think that what is important about being in the $4s (other than it was predicted by some analysts) is that the SP movement post-approval of Tyvaso DPI should lift the floor into the $5s or higher and insitutional investment can and likely will increase and that means more volume, and hopefully less volatility, which may translate into, more volume.
I trust UTHR to achieve their predicted sales results, and that will be positive for MNKD. As I’ve said before, the closer MNKD is to cash flow break even, or crosses over into profitability with a positive EPS and a meaningful P/E ratio, the better the rates of interest on operating capital. I would not be surprised if the MidCap loan was re-negotiated in 2022 or 2023.
It’s been a long strange trip. Let’s hope it’s finally starting to look “normal”. GLTAL’s.
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Post by sportsrancho on Sept 17, 2021 7:21:03 GMT -5
The Priority Review Voucher is supposed to provide an approval (or not) within 8 months after FDA acceptance of the voucher which was in June. That means the FDA has until next February to provide a response. The press release from UTHR in June is what set the expectation that the FDA would be able to provide a response in October. Reading it again, the information in the press release was specific enough that I have to assume that the media/legal teams at FDA and UTHR collaborated on the UTHR press release. I think that’s where the confidence in the October timeframe comes from. Even so, sometimes what looks doable in June with an expected result in October takes longer. Knowing corporations and the government, I won’t be surprised if October comes and goes and there is no announcement. And, I think the SP action may reflect I am not the only one who isn’t betting on an October announcement. As for post-approval (if that happens), I do expect a pretty sharp jump in SP, followed by a re-trace to a higher floor than what we have now. And, I agree with Awesomo that it is business fundamentals that will raise the floor over time. My wild ass guess is the new floor will be between 6 and 8. And it is only a guess (although I told my wife 8 so I’ll almost certainly be wrong on that number). I am unconcerned about the current price movement. We are solidly in the $4s. Some of that is expectations around approval of UTHR’s Tyvaso DPI, and some of that is from business fundamentals in terms of executing on the UTHR agreement (i.e., milestones) and on the improved debt financing. I think that what is important about being in the $4s (other than it was predicted by some analysts) is that the SP movement post-approval of Tyvaso DPI should lift the floor into the $5s or higher and insitutional investment can and likely will increase and that means more volume, and hopefully less volatility, which may translate into, more volume. I trust UTHR to achieve their predicted sales results, and that will be positive for MNKD. As I’ve said before, the closer MNKD is to cash flow break even, or crosses over into profitability with a positive EPS and a meaningful P/E ratio, the better the rates of interest on operating capital. I would not be surprised if the MidCap loan was re-negotiated in 2022 or 2023. It’s been a long strange trip. Let’s hope it’s finally starting to look “normal”. GLTAL’s. |
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Post by Clement on Sept 17, 2021 7:33:25 GMT -5
The Priority Review Voucher is supposed to provide an approval (or not) within 8 months after FDA acceptance of the voucher which was in June. That means the FDA has until next February to provide a response. The press release from UTHR in June is what set the expectation that the FDA would be able to provide a response in October. Reading it again, the information in the press release was specific enough that I have to assume that the media/legal teams at FDA and UTHR collaborated on the UTHR press release. I think that’s where the confidence in the October timeframe comes from. Even so, sometimes what looks doable in June with an expected result in October takes longer. Knowing corporations and the government, I won’t be surprised if October comes and goes and there is no announcement. And, I think the SP action may reflect I am not the only one who isn’t betting on an October announcement. . . It’s been a long strange trip. Let’s hope it’s finally starting to look “normal”. GLTAL’s. "Welcome to BioPharmCatalyst. Our USERGUIDE provides an in-depth overview of tools for PREMIUM and NON-PREMIUM users. A summary of current tools available is noted below but we strongly recommend all users to read the USERGUIDE for a much more thorough overview. BioPharmCatalyst is an online resource for stock market investors of biotech and pharmaceutical companies listed on U.S. markets (NASDAQ and NYSE). Approximately 550 companies are tracked. The primary function of BioPharmCatalyst is to track pipelines of drugs in clinical development. For a drug to receive marketing approval from the Food and Drug Administration (FDA), companies must conduct human clinical trials, generally in three phases (Phase 1-3) before submitting a regulatory filing, normally a New Drug Application, to the FDA for marketing approval. However, BioPharmCatalyst provides much more than just a database to track the development of drug pipelines. Throughout the USERGUIDE we will provide an overview as to which tools are available for both PREMIUM and NON-PREMIUM users and how to best use them." www.biopharmcatalyst.com/about/website-guide |
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Post by casualinvestor on Sept 17, 2021 8:32:22 GMT -5
I'll be a waffle and say Tyvaso DPI is partially priced in. I think it is generally accepted that approval will happen. But it's a lot more than a binary event for MNKD. How fast will UTHR be in converting users? What % of acceptance will users/physicians have? Will there be off-label use for PAH-ILD (is this allowed? I know UTHR has no say, but can physicians make this decision)?
If memory serves, we've seen estimate numbers such as 50-70% converted from Tyvaso in a year. But with a better inhalation system and better results, how many people will be pulled in from other products too? Late Oct/early Nov could see some news for this at the Q3 meeting. That makes for a really rocky timeframe for shorts, but they could just cover with options.
Then on to the next indication. What will the FDA need to approve TyvasoDPI for PAH-ILD? Since Tyvaso is approved for ILD, and TyvasoDPI will have just been approved for PAH, I'm hoping it's a short study.
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Post by Clement on Sept 17, 2021 9:19:05 GMT -5
I'll be a waffle and say Tyvaso DPI is partially priced in. I think it is generally accepted that approval will happen. But it's a lot more than a binary event for MNKD. How fast will UTHR be in converting users? What % of acceptance will users/physicians have? Will there be off-label use for PAH-ILD (is this allowed? I know UTHR has no say, but can physicians make this decision)? If memory serves, we've seen estimate numbers such as 50-70% converted from Tyvaso in a year. But with a better inhalation system and better results, how many people will be pulled in from other products too? Late Oct/early Nov could see some news for this at the Q3 meeting. That makes for a really rocky timeframe for shorts, but they could just cover with options. Then on to the next indication. What will the FDA need to approve TyvasoDPI for PAH-ILD? Since Tyvaso is approved for ILD, and TyvasoDPI will have just been approved for PAH, I'm hoping it's a short study. p 28 of UTHR's latest 10Q (2Q 2021): "Tyvaso DPI We have developed a dry powder formulation of inhaled treprostinil called Tyvaso DPI, under an in-license from MannKind Corporation (MannKind). Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. If the FDA approves Tyvaso DPI, we believe this new inhaled treprostinil therapy will provide substantial lifestyle benefits to PAH and PH-ILD patients" ". In April 2021, we filed an NDA with the FDA seeking approval for Tyvaso DPI to treat both PAH and PH-ILD." s1.q4cdn.com/284080987/files/doc_financials/2021/q2/UTHR-10Q-Q2-2021-Draft-8-(with-exhibits)-August-3-2021-8PM.pdf |
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Post by Clement on Sept 17, 2021 15:03:00 GMT -5
How do you like that extra 3M shares right at the very end of the day!
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Post by peppy on Sept 17, 2021 15:06:59 GMT -5
MNKD NASDAQ real time volume, 8,480,556 shares. (do the math. x $4.50 = 38 million.) MNKD nasdaq summary volume, 6,181,575. (3 million shares came in at the end of the day.) Avg. Volume 2,909,546 4.53. -0.03 (-0.66%) At close: 4:00PM EDT  |
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Post by mymann on Sept 17, 2021 15:38:13 GMT -5
What happened? At the end of Friday.
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