|
Post by agedhippie on May 15, 2023 13:16:18 GMT -5
I have never written a patent but I thought there was supposed to be something "novel" about it. But thanks for reminding me about the reality of the situation. The design of VGO is pretty. But it also looks like something that, on a larger scale, Uncle Joe and his dog Bucky would assemble for one of the oil company research labs. Figure 1 www.mdpi.com/2226-4787/8/4/215It's novel until it's challenged. I have a couple of patents in my name, only one of which I think could withstand scrutiny, but that's what the customer wanted...
|
|
|
Post by agedhippie on May 15, 2023 13:13:00 GMT -5
There is a takeover case that isn't much talked about. If a company generates more cash than it would take to service the debt required to purchase the company then there is a takeover risk. This can happen when the share price under-performs the revenue and is why the CFO dog and pony shows are so important. When you're sitting on cash, substantial and increasing royalties and sales revenue, patents, and a credible pipeline, and debt with good interest terms, M&A and other deals seem like a more real possibility. You don't need any of that beyond your free cash flow being able to service the debt. This is a particular problem for companies that are royalty or franchise based because the acquirer can dump all the expensive staff to save their salaries and run it with a skeleton crew whilst cashing the cheques. I worked with a company that had this problem and their answer was to take on debt for share buy backs which increased their share price and reduced their free cash flow making them less exposed.
|
|
|
Post by agedhippie on May 15, 2023 10:24:52 GMT -5
Thank you. Very interesting. Floating-piston transfer cylinders and restrictors have been in public domain for several decades. You can patent anything provided it's not obviously flawed, but it will get overturned if it matters (mostly nobody cares so they skate by.) However, a bad patent has it's use as it enables you to delay your competitor by continually appealing the judgement overturning the patent and so delaying your competitor. Companies build arsenals of patents for exactly this reason, they don't need to ultimately be valid, they just need to burn time. The UTHR case against LQDA is a fine example of this.
|
|
|
Post by agedhippie on May 15, 2023 10:16:00 GMT -5
There is a takeover case that isn't much talked about. If a company generates more cash than it would take to service the debt required to purchase the company then there is a takeover risk. This can happen when the share price under-performs the revenue and is why the CFO dog and pony shows are so important.
|
|
|
Post by agedhippie on May 15, 2023 10:13:14 GMT -5
"Anticipated" has no legal standing and in that context is being used to give an estimated value for forward calculations. Under the CSA the only case in which UTHR would be liable is if they asked MNKD to scheduled an order and then cancelled (the orders are based on a rolling schedule.) Mannkind is obliged to accept any order up to 90% of existing capacity plus expansion capacity as defined by schedule C which is helpfully excised! UTHR also has the right to assign manufacturing to a 3rd party under the terms of the licensing agreement. On investment by UTHR in equipment; UTHR retains title, and any space required for the equipment at Danbury will be provided at cost (not cost plus).
|
|
|
Post by agedhippie on May 14, 2023 15:50:45 GMT -5
Mike actually said hostile takeover?🤦🏼♀️ "The additional shares of common stock that would become available for issuance if the proposal is adopted could also be used by the Company to oppose a hostile takeover attempt or to delay or prevent changes in control or management" from page 22 of the PRE 14A. investors.mannkindcorp.com/node/18861/html#proposal2 That's a boilerplate clause that you always find in every proposal to increase the share count. Certainly it's in the 2020 and the 2017 share increases. You will find it in other companies filings as well. It sounds better than dilution
|
|
|
Post by agedhippie on May 14, 2023 15:35:28 GMT -5
First, UTHR has a 10 year commitment to manufacture Tyvaso-DPI with MNKD. I have heard Mike say that one of the reasons for the extra shares is to prevent a hostile take over. That’s conceivable in my mind when companies realize the royalty payments for MNKD no matter who produces it. There is a 10 year commitment in the contract. but there is no quantity mentioned in that contract so it's basically grants UTHR the right to have MNKD manufacture Tyvaso-DPI as and when UTHR requires. MNKD cannot force UTHR to use them for manufacturing Tyvaso-DPI as things currently stand, and the agreement expressly says that. This is not to say that UTHR are going to take manufacturing away tomorrow, but if this becomes a blockbuster drug then they absolutely will take manufacturing into their own plant, but probably retain MNKD as a backup if needed via the 10 year agreement. Of course if it ever reaches that stage MNKD will be making so much money from the royalties that the manufacturing revenue will be irrelevant.
|
|
|
Post by agedhippie on May 14, 2023 11:01:46 GMT -5
I suppose I should also say that UTHR building their own plant within Danbury gives them the option to take over the production there at a later point. When the Tyvaso and Afrezza lines are co-mingled that would be almost impossible. Once there is an area with lines dedicated to Tyvaso it's a lot easier. That said I doubt they do take it over because of the operational implications (a small plant remote from their existing facilities that they would need to staff and maintain), but it gives an option.
|
|
|
Post by agedhippie on May 14, 2023 10:54:59 GMT -5
UTHR paying for plant expansion would certainly bring up interesting speculation since Mannkind no longer owns the plant but is leasing it back. Sorry, let me use different words to explain. UTHR is paying for the increased manufacturing capacity coming this quarter and later this year. MC has said several times that the Danbury facility has plenty of "shell space". So UTHR is not paying for a new building in Danbury, but it is paying for improvements and another assembly line to increase manufacturing capacity. So basically UTHR will own the equipment and pay for the labor to install it on the existing site? Since the manufacturing is a cost plus deal that would make sense since any associated costs would be passed to UTHR any way under the contract. That equipment would then be dedicated to Tyvaso DPI which would free up existing capacity for Afrezza. I would expect UTHR to grow capacity incrementally since it makes no sense to incur capital costs for idle equipment.
|
|
|
Post by agedhippie on May 13, 2023 10:05:44 GMT -5
This is the newer version of that debate from last year. Note the disclaimers about the pump not being CGM linked AID pumps (which is what they both use IRL) www.youtube.com/watch?v=9YT4RbfJk6wThanks - my take away is Hirsh and Edelman are now both afrezza fans and users. I think afrezza got more earned advertising on this video than any other insulin. Why did it take Hirsh all these years to finally come around? Aged - now that Hirsh is on-board, I guess its your turn. Hirsch has been using it for a long time, and prescribing it since release. Both he and Edelman use it as a supplement and not their primary treatment.
|
|
|
Post by agedhippie on May 13, 2023 9:36:03 GMT -5
Hope this is not an overly simplified post but why would a doctor prescribe LQDA's product that requires 60% more of it to do the same thing as Tyvaso DPI? ... I think it is a huge over simplification. The quantity of drug is irrelevant if the delivery is easy - a case in point is Afrezza which is definitely not efficient in terms of the quantity of insulin needed in it's manufacture, but has an easy delivery making that inefficiency irrelevant. If the LQDA delivery is easy then nobody will care if it uses 60% more of the active component for the same effect. What's really funny is that I remember Looking For Diogenes making exactly this argument against Afrezza. I clipped the bit on sales strategy since I have no idea how the LQDA reps sales pitch would go. I suppose whatever pharma reps sales usually do.
|
|
|
Post by agedhippie on May 12, 2023 22:39:14 GMT -5
This is the newer version of that debate from last year. Note the disclaimers about the pump not being CGM linked AID pumps (which is what they both use IRL) www.youtube.com/watch?v=9YT4RbfJk6w
|
|
|
Post by agedhippie on May 12, 2023 18:46:17 GMT -5
That would be unsurprising. If you have a rapidly growing product line you need to be able to meet demand. UTHR have a recurrent nightmare that they run out of road to continue blocking LQDA and LQDA vacuum up all the unmet demand. UTHR need to be meeting demand by the time LQDA launches which is probably about a year out. Havent been keeping up with LQDA, but does LQDA have a large manufacturing plant(or building one right now) to produce the volume they would need to do this? They have a manufacturing plant, no idea of the the size though. UTHR is going to get the bulk of the market, LQDA is going to get a chunk of the rest so they don't need a huge plant (they may have visions of a bigger share, but I think that's mostly to support the share price.) Fundamentally this is a rerun of the RAA vs. Afrezza show, but with MNKD on the side of the gorilla this time.
|
|
|
Post by agedhippie on May 12, 2023 18:38:46 GMT -5
That's big news. I wonder what aged thinks of this. I remember him and Edleman doing a debate/presentation years ago. Edelman uses Afrezza too. I Any video of the debate? So, Irl Hirsh is suppose to be an "expert" in diabetes. Why did it take him so long to start using it? He has talked about it going back to 2010, and prescribed it since it first launched. Both he and Steve Edelman are on AID pumps using Afrezza as a supplement. I have followed his academic work for years - definitely an expert (helped by the fact that he has Type 1).
|
|
|
Post by agedhippie on May 12, 2023 17:45:41 GMT -5
That's big news. I wonder what aged thinks of this. I remember him and Edleman doing a debate/presentation years ago. Edelman uses Afrezza too. I He has used it for a while and even talked about it. He primarily uses a looped pump, but he uses Afrezza for occasional fast carbs. This is why I keep on saying they should do a study combining an AID pump with Afrezza for rescue. Rescue is a bit misleading though and does Afrezza a disservice, really it's for flattening a spike you know the pump is going to screw up. The latest generation of pumps are pretty good at handling minor unannounced excursions, but at a certain point they lose the plot and then it takes time to reestablish baseline. What you are seeing is people largely leaving their pump to run things, but using Afrezza when they know the pump is going to lose it (risotto anyone?). The pump is going to eliminate the need for a follow-on dose because that's in the range it can handle. I think it would be relatively easy to design a protocol where you used Afrezza if there were more than a certain amount of fast carbs and offset those carbs in what you told the pump you had eaten, the pumps not going to be shocked by an unexpected spike and will adjust to clean up the remainder. Why not use Afrezza all the time? It's increasing the burden, let the pump handle the easy stuff - they are good at it. So it reiterate a much earlier post - do a trial with AID pumps with Afrezza support. That will get attention and traction. Replacing pumps is a pipe dream (put a reminder in to correct me in five years )
|
|