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Post by prcgorman2 on Aug 22, 2019 15:58:24 GMT -5
Yup. The molecule is a swell product.
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Post by ktim on Aug 22, 2019 16:02:49 GMT -5
A couple of hours ago I received a surprisingly complete and generally positive by Spencer Osborne. I think Spencer may have turned the corner on MNKD, as he seems to finally understand Mike's vision and direction, and I think it also puts to bed the VDEX activism issue. What I found particularly interesting are: 1) In discussing the revisions to the Amphastar agreement, Mike noted: "Additionally, we were able to free up the Afrezza rights in China, for which previously Amphastar had right of first refusal." That is a potentially significant income stream down the road. 2) Mike was ever so clear as to why MNKD Management has rejected the activist moves by Bill McCullough (VDEX/EFM), the most significant point being Bill's promotional tactics, which Mike described as: "Vdex’s marketing practices and statements about Afrezza triggered a letter of inquiry to us from the FDA. As a result of their tactics, we cannot be associated with Vdex without creating the perception that we condone off-label promotion. We made Bill aware of this issue, but his meeting notes and subsequent videos in which he criticizes MannKind management as unimaginative and constrained to conventional pharma thinking suggests that he doesn’t take FDA compliance seriously." 3) In discussing UTHR's next molecule, Spencer has speculated in prior articles it will be Adcirca. Mike has not yet disclosed what it will be, but Spencer noted: "Adcirca is Tadalifiol, the same active ingredient for the erectile dysfunction drug Cialis. United licensed Tadalifil from Lilly (LLY)for PAH treatment. If (and that is a big if) the undisclosed molecule is Adcirca, the United rights are limited to PAH. This would mean that MannKind would retain the rights for an ED indication." That is also a potentially significant income stream down the road. Here's the link to the full article, if you have not received... seekingalpha.com/article/4287312-mannkind-fireside-chat-ceo-mike-castagnaYou know I am loving this. Paraphrasing Mike C: " The molecule has high customer demand." That must mean it's an opiod
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paul
Researcher
Posts: 134
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Post by paul on Aug 22, 2019 16:04:17 GMT -5
I don't see being "able to free up the Afrezza rights in China" as a positive. Why would Amphastar give up right of first refusal to a country the size of China? Did they decide it wouldn't be a viable market for inhaled insulin?
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Post by ktim on Aug 22, 2019 16:27:02 GMT -5
I don't see being "able to free up the Afrezza rights in China" as a positive. Why would Amphastar give up right of first refusal to a country the size of China? Did they decide it wouldn't be a viable market for inhaled insulin? I wouldn't read that much into it. Lot's of potential dimensions to a business decision like that.
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Post by akemp3000 on Aug 22, 2019 18:00:08 GMT -5
I don't see being "able to free up the Afrezza rights in China" as a positive. Why would Amphastar give up right of first refusal to a country the size of China? Did they decide it wouldn't be a viable market for inhaled insulin? I wouldn't read that much into it. Lot's of potential dimensions to a business decision like that. Exactly. It was probably one of many topics being negotiated. It's positive in that Mannkind now has the rights and control if desired in future negotiations with any BP. It also gives Mannkind the ability to go it alone unencumbered.
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Post by prcgorman2 on Aug 22, 2019 18:08:41 GMT -5
I don't see being "able to free up the Afrezza rights in China" as a positive. Why would Amphastar give up right of first refusal to a country the size of China? Did they decide it wouldn't be a viable market for inhaled insulin? The right of first refusal would not be free. Think about it.
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Post by wgreystone on Aug 22, 2019 18:45:28 GMT -5
I don't see being "able to free up the Afrezza rights in China" as a positive. Why would Amphastar give up right of first refusal to a country the size of China? Did they decide it wouldn't be a viable market for inhaled insulin? The right of first refusal would not be free. Think about it. So why Amphastar gave it up seemly for free?
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Post by ktim on Aug 22, 2019 19:20:54 GMT -5
The right of first refusal would not be free. Think about it. So why Amphastar gave it up seemly for free? Even if they thought there was an opportunity, they might have decided it didn't fit with their overall strategy. In those situations it might have more value to MNKD than to Amphastar (and undoubtedly not a right that Amphastar could sell/transfer to anyone else). Those are good chips to have in negotiation where you can give something up that the other party values, but doesn't have much value to you. I'm presuming that Amphastar, for whatever reason, decided they didn't won't to market in China since they've had a long time to commence something and have chosen not to.
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Post by sportsrancho on Aug 22, 2019 19:23:17 GMT -5
Could we have a China partner in the wings?
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Post by apidistra on Aug 22, 2019 19:52:14 GMT -5
Let's hope not. China distribution is fraught with extraordinary problems that never, and I mean never, play to success.
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Post by prcgorman2 on Aug 22, 2019 20:07:57 GMT -5
Success? Hmmm, it's an enormous market opportunity. How many ways could it present opportunities for success? MC has mentioned in the past that both Brazil and India are not likely to be big money makers but could help defray cost of manufacturing Afrezza. India has more than 1 billion people. China does too. Success doesn't have to be in terms of dramatic profit on shipments to China, but could be in lowering costs in the U.S. I also wonder if a large pool of Afrezza users in China could, over time, provide a valuable resource for data mining. (I wonder how many CGMs are manufactured in China?)
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Post by awesomo on Aug 22, 2019 20:08:24 GMT -5
Let's hope not. China distribution is fraught with extraordinary problems that never, and I mean never, play to success. Never play to success? Pretty sure almost every company would love to be a player in China.
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Post by sportsrancho on Aug 22, 2019 20:14:06 GMT -5
Here’s some of Spencer‘s comments I thought you guys might find interesting .....
United is only licensed for tadalafil (cialis) for the indication of PAH. They can not and do not market Adcirca for ED. United licensing with mannkind is only for the indication of PAH. Months ago I covered that the undisclosed PAH molecule is most likely Adcirca. Mannkind retains the rights to any indication outside PAH. If Adcirca is selected, the UTHR path would be for PAH. A lot of the clinical trial data (safety data, profile data, etc.) for inhaled Adcirca could cross over and be used by Mannkind to persue a dry powder inhaled tadalifil indication for ED on its own if it desired to take that path. At this moment, given the licensing structure of united/lilly and united/mnkd, the indication is only for PAH. Part 1 part 2. The lily/united deal has united paying $325,000 per $1 million in net revenue PLUS a 10% royalty. That deal is through the end of 2020. The first issue united has to decide is how substantial the generic competition will be after 2020 and whether it feels it can hold share with an inhaled version. If it decides it can, it will move forward...but...lily controls all regulatory actions related to tadalufil. This is a very complex deal with a lot of moving parts. Generic adcirca is already chipping away at sales. Between fixed supply costs for tadalifil a tough payment and royalty structure, and perhaps new royalties to mannkind, united is facing giving up over half of its net revenue on the drug, while facing a deal that expires december 31, 2020.
few things...1)the guard at the entry (I will leave his name private) recognized my name. Great guy. 2) the positive attitude of everyone I came across and saw 3) a lot of extra space at the property (underutilized at present) 4) I got more candor than I expected....guard was great. First employee I met coming in the gate. Asked my name, and perked up because he recognized it. We had a great talk.
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Post by sportsrancho on Aug 22, 2019 20:21:43 GMT -5
Could we have a China partner in the wings? Kevinmik....Mike did mention in the interview that Mannkind successfully freed up Afrezza in China from Amphastar, who had first right of refusal. Reasons why Amphastar agreed could be Mannkind has a partner ready to go in China and Amphastar refused to exercise their first right of refusal option. Either Amphastar isn't ready or willing to commercialize Afrezza in China or Mannkind has a solid partner who may use Amphastar to supply the insulin. There may be other reasons that we will never know about. If Mannkind announces a China partner, they we know Amphastar likely refused to override the deal.
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Post by prcgorman2 on Aug 22, 2019 22:37:02 GMT -5
MC did also mention "other" partnerships that might come along. And, SO said Mike was being conservative. SO also said his opinion was MNKD is a trader stock for the next 2 to 6 quarters, but how much was MC sharing Mannkind's cards? Crap. I'm getting nervous about how long to wait on my next (and potentially last) MNKD purchase.
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