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Post by agedhippie on Jan 7, 2024 15:00:04 GMT -5
I assume the “optionality” refers to the excess income from interest income on the $150M above and beyond the interest expense on the $230M convertible notes, and on the reduced expense associated with the Amphastar insulin. It means, debt can be paid down faster, or be reinvested in operations, etc., or simply allowed to accumulate in the bank. Just my guess. I think it was an attempt to contain the damage from the position that this money is going on settling our debts. I am willing to bet that wasn't well received. What I feel he is saying is basically what you said, it's use isn't cast in stone.
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Post by agedhippie on Jan 7, 2024 8:17:17 GMT -5
so far that is the case. Things change. Say aged, you are knowledge to know this..... What is the dollar cost of a submission?..... even over your objection? I mean since insulin is a $35 co charge now. ... ;By the way, I had no clue how many type two's end up in renal failure. I had to study up and look at the glomerulus. The capillaries around the glomerulus clog up with glucose or fructose and the glomerulus loses its nutrient supply and dies? It's hard to submit a request for something that no-longer exists. This is Monty Python Norwegian Blue territory The dirty little secret of diabetic CKD is that it is driven far more by blood pressure than it is by glucose levels. This is a problem in Type 2 is that it's a metabolic disfunction and part of that is high lipids and high blood pressure - so a perfect storm.
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Post by agedhippie on Jan 7, 2024 7:39:30 GMT -5
What does ATTD abbreviate in the clinical trials? And at the end of the conference call on the Segard deal mike closed with a statement of ( we now have optionality on our company). I liked the way that sounds! ATTD is a journal and conference on technology in diabetes isn’t it? The full quote on optionally is: We now have optionality on our company to pay down our debt and continue to grow our company for success.
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Post by agedhippie on Jan 6, 2024 23:17:54 GMT -5
He is not presenting on Wednesday, he is presenting on Thursday at 11:15 am Pacific time. LQDA is presenting on Wednesday, also at 11:15 oddly enough.
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Post by agedhippie on Jan 6, 2024 23:16:21 GMT -5
Afrezza over the counter. I think a push should be made for that. Regular inulin is over the counter. Afrezza is regular insulin. Regular insulin with a device. A syringe is a device. A pump is a device. It would solve the problems. Price could come right down as the lines ramped up. No way the FDA ever allow Afrezza to be sold OTC. The existing exceptions are the result of grandfathering under a law that no longer exists and are specific to Lilly and Novo Nordisk as the only manufacturers at that point in time.
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Post by agedhippie on Jan 6, 2024 11:17:08 GMT -5
But if we price it at $35 we could be losing money on each prescription. We shareholders don't know the actual cost. The largest cost is the sales force but was the care and feeding of the empty factory until Tyvaso DPI filled it up. We do know afrezza is now profitable thanks to factory cost sharing with Tyvaso DPI and sales force restructuring, i.e. Mike had lay-offs. ... I strongly advise that you go away and read the last 10Q and consider what it means to reduce the Afrezza sales revenue by an order of magnitude. The TLDR is that it absolutely would not be profitable.
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Post by agedhippie on Jan 6, 2024 11:11:14 GMT -5
Another reason to fire 37% of the sales force. What was it before? I thought earnings call said q4. I believe what Mike said is we will have the numbers by Q4. I don't think that is changing. FDA approval should be 3Q2025 but should be the talk of ADA2025 along with any impacts the Cipla results can make to 2025 T2 SoC and label changes. He will have an update on this when he presents on Wednesday. It's not changing, it already has changed! The old date: Primary Completion: December 2023, the new date: February 2024. The last endpoint will be six months after that so roughly Q3 before there are numbers. Then there is the QC phase which is another six months which is how we land at April 2025 for the final results from pediatrics.
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Post by agedhippie on Jan 5, 2024 23:21:59 GMT -5
Apparently not. The EMA could find no causal link, and since they see literally all the prescriptions and outcomes not to mention cancer cases in Europe, it seems like that one can be put to bed. Tell it to the FDA. Black box warning WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. ... The FDA relies on the drug companies to do the work, the EMA goes out and collects the data from the EU national health systems proactively. So while the FDA says it cancer in the mouse model the EMA have done the research to discover that it doesn't cause cancer in humans. The mouse model (rats and mice) is seldom a close match for humans, but if you are going to test to destruction you cannot use people. After all they can cure Type 1 diabetes in mice...
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Post by agedhippie on Jan 5, 2024 19:49:03 GMT -5
I think it will be well received because it shows that an independent firm valued the Tyvaso DPI revenue stream as being worth $1.5 billion presently. That I think will resonate a bit in the market when you have a company that is either break even or close to break even and is only currently valued at ~$1 billion. It depends on what period Sagard expect to recover their money over. Since it's unlikely to be one year I think we can safely dispose of the idea that MNKD is holding a $1.5B annual revenue stream.
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Post by agedhippie on Jan 5, 2024 19:45:42 GMT -5
Your welcome. Saxenda® (liraglutide)Ozempic® (semaglutide)
as long as the word ends in tide. You look good.........That is not a thyroid tumor. Apparently not. The EMA could find no causal link, and since they see literally all the prescriptions and outcomes not to mention cancer cases in Europe, it seems like that one can be put to bed.
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Post by agedhippie on Jan 5, 2024 9:12:16 GMT -5
Maybe insiders are prohibited from buying right now. If they have anything material to announce at the JPM conference, then they can't legally front-run the news. TBH if I was Mike (or any company officer) I wouldn't trade ahead of the conference. In all likelihood it wouldn't be illegal, but it's better to avoid the risk of frivolous lawsuits claiming that it was.
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Post by agedhippie on Jan 4, 2024 21:26:54 GMT -5
What was said on the conference call was “under-valued”, not “suppressed”. I agree that insider buying would underscore that assertion much better than it just hanging out there unsupported. On the other hand, my gut says MNKD has been heavily manipulated from time to time so “supressed” might be how the execs feel versus “under-valued”. If you thought the price has been manipulated and suppressed, seemingly at will (ah, but whose will?), would you have the guts to throw a lot of your salary at insider buying? Now, if there was an ESPP and it permitted generous buying, at a discount, then the buy can be hedged, but even then, is there any guarantee the action will yield the desired result? Obviously, no. It’s easy to bravely talk about how other people ought to spend THEIR money, but if it was your money, how would you behave? ... If I knew the price was being suppressed then I absolutely would buy, but if I only suspected then I wouldn't because the risk of confirmation bias is far to high. Undervalued is a different story. There is the old saying, the market can remain irrational longer than you can remain solvent. I avoid stocks that are "undervalued" unless I can see a binary event with a high probability of removing the reason the market is undervaluing them with a solid timeline, and then I would probably buy calls.
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Post by agedhippie on Jan 4, 2024 20:56:08 GMT -5
I don't know about anyone else, but I consider a buy to be more bullish than a sale to be bearish. The sales may be the only way an insider can raise cash because life happens (divorce or otherwise. I had an unexpected need for cash recently and I just had to dump stuff. I tried to take a little from every possible source, but someone focused on, say, some particular sale of mine because it happens to be of shares of the company I work for, would not be aware of the context). OTOH, if I see an insider choose to buy shares, that's a pretty unambiguous endorsement of that equity. So now tell me how I'm oversimplifying it, because I assume I probably am. I heartily agree with this with the exception that buy and hold is bullish, buy and immediately sell is not. I don't really care about insiders selling because sometimes you have to. As an example Amazon used to make you take around half your salary as RSUs so unless could live on half pay you were going to be selling the stock as it was granted!
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Post by agedhippie on Jan 4, 2024 19:18:57 GMT -5
I realize Nates Notes is out of bounds for our readers (and mods) on this forum. If anyone has an interest in updates to the Standard of Care for diabetes 2024 he has great news from his type 1 dad on ST. What is it? And Nates Notes is not out of bounds as far as I know, it provides great entertainment
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Post by agedhippie on Jan 4, 2024 19:17:25 GMT -5
Thank you for correcting my math.... If UTHR revenue on Tyvaso DPI = $4B/yr (currently its at ~$1B/yr), then MNKD gets $400M/year (less 10% to Sagard) = $360M/yr. Sagard gets $40M/yr. $150M divided by $40M/yr = 3.75 years for Sagard to get their $$ back!Is the quick analysis above correct? If so, didn't Mannkind drastically short-change itself by selling off a long-term royalty stream for so little? Even worse, with interest rates heavily anticipated to drop in the next year, the present value of the long-term royalty stream will probably increase by, conservatively, at least 20% in the next year or two. Discuss? It's over-simplified. The net revenue has to get to $4B and that's not happening overnight, and second I think it's pretty certain that there will be an extra $45M or $50M milestones so I would have used $200M rather than $150M. It is a good deal for Sagard though because it's a 20 year revenue stream. It's the same principle as selling an annuity - think JG Wentworth
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