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Post by mnholdem on Dec 20, 2019 20:43:54 GMT -5
This study aka Affinity-1 was the basis for the 13-1 Adcom vote to approve. Here is the original PR from 2013. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-positive-clinical-data-afrezza-both-affinityThe primary focus was A1c reduction. All insulin reduces A1c. The more insulin the greater the reduction. The problem is not getting a hypo. afrezza in 171 was non-inferior in A1c but superior in hypos. However, the lower hypos were not discussed much back in in the day. Dr. Kendall is now laying the foundation for the "ultra acting" class showing afrezza is a game changer because of the biggest issue insulin has - hypoglycemia. CMO David Kendall made a point last year when he stated that data from more than ten years of trials and studies remained unpublished. MannKind never had a Chief Medical Officer with the credentials and experience to make sense of all that data until they hired Dr. Kendall, one of the medical industry’s leading expert in diabetes research. I was annoyed by the unexplained delay, but I am delighted that this information is finally being disseminated. |
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Post by mnholdem on Dec 18, 2019 12:35:59 GMT -5
There was an index mannkind was added to? Or more investors are buying Index(aka getting back in the market)? In changes from last quarter the three largest buyers were all trackers. Biggest institutional holder - Blackrock Inc aka. iShare ETFs. People (including me  ) will believe what they want which is what makes investing interesting. The most interesting large new buyer is the Bruce Fund, but I am not sure if that warrants they are holding or real stock. From Page 28 of MannKind's 10-Q filed with the SEC on Aug 7, 2019: "Exchange of 2021 Convertible Notes for 2024 Convertible Notes and the Indenture for the 2024 Convertible Notes
On August 6, 2019, MannKind entered into a privately-negotiated exchange agreement (the “2021 Note Exchange Agreement”) with Bruce & Co., Inc., for itself and on behalf of the beneficial owners of the holders of MannKind’s outstanding 2021 notes, pursuant to which MannKind agreed to, among other things, (i) repay $1,470,147 in cash to such holders ($1,500,000 less the amount of interest accruing under the 2021 notes between August 6, 2019 and August 15, 2019), (ii) issue 4,017,857 shares of MannKind’s common stock to such holders (at a conversion price of $1.12 per share), (iii) issue new 5.75% Convertible Senior Subordinated Exchange Notes due 2024 (the “2024 convertible notes”) to such holders pursuant to the provisions of an indenture (the “Indenture”) in an aggregate principal amount of $5,000,000 and (iv) issue two non-interest bearing promissory notes to such holders, each in the amount of $2,630,750, one of which will mature on June 30, 2020 (the “June 2020 note”) and the other of which will mature on December 31, 2020 (the “December 2020 note”, and together with the June 2020 note, the “2020 notes”), in exchange for the cancellation of the $18.7 million in principal amount of the 2021 notes. The 2020 notes may be prepaid at any time on or prior to their respective maturity dates at the option of MannKind. In addition, MannKind may elect to pay the 2020 notes at any time on or prior to their respective maturity dates, if certain conditions are met, in shares of MannKind’s common stock at a price per share equal to the last reported sale price on the trading day immediately prior to the payment date. The exchange pursuant to the 2021 Note Exchange Agreement was effected on August 6, 2019." |
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Post by mnholdem on Dec 10, 2019 12:34:22 GMT -5
liane and BD double the moderators' pay every year.
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Post by mnholdem on Dec 9, 2019 8:54:25 GMT -5
The facts are that Director Hooper is simply replacing retired Director MacCallum's seat and it's reasonable to assume that the addition of the new Director is not some attempt to prevent HfM from securing a majority of the Board votes via the nomination process. As I said the other day, I prefer facts over fiction.  if this is true, which I am quite sure it is, then Bill McCulloughs recent letter to shareholders was highly unnecessary and too reactionary. Not at all. In fact, I do agree with Mr. McCullough that the Board of Directors may be too heavily weighted with pharmaceutical executives. |
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Post by mnholdem on Dec 8, 2019 11:58:02 GMT -5
If UT becomes the majority SH of a future profitable Mnkd who pays no tax for a foreseeable future due to $3B NOL, Ops margin becomes pure profit margin. Furthermore, UT could potentially give generous mfgr and R&D contracts to Mnkd to make MNKD more profitable while not paying tax, maybe dividend. Even SO saw it too. He said UT could buy in phases to take advantage of $3B NOL. Once UT becomes majority SH, UT and Mnkd’s interest align. UT would want to make Mnkd tax free profitable. Mnkd would become an outsourced R&D and mfgr arm of UT plus tax free royalty - a legal non-Bermuda tax shelter for both companies. You can ask if the future Mnkd Director, mnholdem, likes the idea such as how much % for the initial stake, valuation, 2nd stake, 2nd valuation, the trigger. Let’s start the mock interview before he becomes the official Director, then can’t say much. It’s a golden opps to pick his brain as he can freely talk now. Mnholdem’s chance of being elected is high as I believe Thompson will certify 5%, then he will get more than enough vote. I’d treat Mnholdem as Director elected now. Pick his brain everyone for all biz matter. I still believe UT may likely take the initial stake before next May ASH meeting, before the new slate of Directors getting elected when it will be harder to get a unanimous approval and valuation will be higher. This is a somewhat tricky question to answer, primarily because in 2017 the IRS made changes related to Section 382 and the handling of NOLs under Section 172 in regard to change of ownership after an owner/equity structure shift. After an acquisition, say of MannKind for example, Section 382 will limit the amount of MannKind NOLs available to offset future taxable income. Also, CEO Castagna and CFO Binder secured the current MidCap financing with valuable IP, so MannKind NOLS could be subject to additional limitations caused by early ownership changes incurred during rounds of financing. It's complicated but the new code basically states the following: Section 382 Limitation
After an ownership change, the new loss corporation may only deduct its pre-change losses against taxable income in an amount equal to the Sec. 382 limitation amount. There are now three components or attributes to the Sec. 382 limitation as a result of the TCJA:
1. Base limitation, which is driven by the value of the stock
2. Built-in gain/loss, which is driven by the value of the assets, and
3. Disallowed interest expense that exceeds the limits ascribed in Section 163(j).
Notice 2010-50
For Sec. 382 purposes any change in proportionate ownership which is attributable solely to fluctuations in relative FMVs of different classes of stock will not be taken into account. Under Notice 2010-50, the IRS will not challenge the reasonable application of the following two methods as long as either is applied consistently:
1. Full Value Methodology, in which the determination of the percentage of stock owned by any person is made on the basis of the relative fair market value of the stock owned by such person to the total fair market value of the outstanding stock of the corporation, or
2. Hold Constant Principal, in which the value of a share, relative to the value of all other stock of the corporation, is established on the date that share is acquired by a particular shareholder.
Changes to Section 172
Subsequent to the enactment of TCJA, the NOL deduction for a tax year is equal to the lesser of:
1. The aggregate of the NOL carryover to such year, plus the NOL carrybacks to such year, or
2. 80 percent of taxable income (determined without regard to the deduction.)
Generally, NOLs can no longer be carried back but are now allowed to be carried forward indefinitely. Prior tax law generally allowed for a carryback of NOLs for two years and a carryforward of NOLs for 20 years. The change to Sec. 172 will impact the valuations of NOL benefits for both tax and financial reporting purposes going forward.
--- I'm not dodging your question. I'm simply pointing out that the the NOL issue can be complicated. MannKind should definitely be assessing all business opportunities and evaluating their financial impacts - positive and negative. I wouldn't be too eager to give away long-term assets for short-term benefits. |
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Post by mnholdem on Dec 7, 2019 23:17:00 GMT -5
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Post by mnholdem on Dec 7, 2019 16:49:14 GMT -5
Let me guess...the Erectile Dysfunction API? (LOL)
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Post by mnholdem on Dec 6, 2019 20:07:34 GMT -5
Google "presentation by david kendall md diabetes" and select videos. There are quite a few, including this one of Dr Kendall from ADA 2018. vimeo.com/292936650 |
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Post by mnholdem on Dec 6, 2019 8:28:59 GMT -5
The facts are that Director Hooper is simply replacing retired Director MacCallum's seat and it's reasonable to assume that the addition of the new Director is not some attempt to prevent HfM from securing a majority of the Board votes via the nomination process. As I said the other day, I prefer facts over fiction. |
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Post by mnholdem on Dec 6, 2019 8:17:38 GMT -5
Contrary to some posted suggestions, MannKind Corporation has NOT expanded the Board of Directors from 7 to 8 members. ELECTION OF DIRECTORS
MannKind’s Board of Directors currently consists of eight directors. There are seven nominees for director this year, all of whom were nominated by our Board of Directors, consisting of our incumbent directors other than Mr. David MacCallum, who we did not nominate for reelection at the annual meeting as a result of his preference to retire from the Board at the end of his current term. Each director to be elected will hold office until the next annual meeting of stockholders and until his or her successor is elected, or until the director’s earlier death, resignation or removal. All nominees listed below are currently our directors and were previously elected by our stockholders at the 2018 Annual Meeting of Stockholders, except for Ms. Christine Mundkur who was appointed to the Board in November 2018. It is our policy that directors are invited and expected to attend annual meetings. All of the then-standing directors, except Messrs. MacCallum and Nordhoff, attended the 2018 Annual Meeting of Stockholders.
Source: 2019 Schedule 14A Proxy Statement www.sec.gov/Archives/edgar/data/899460/000114036119005883/bp18389x2_def14a.htm#tPROP1 |
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Post by mnholdem on Dec 3, 2019 22:11:25 GMT -5
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Post by mnholdem on Dec 2, 2019 13:18:15 GMT -5
Having problems with your caps key? Ok lets go through this: - The number of scripts you are quoting per location is flatly wrong, it's not even the same number as Mike claimed! Truth is you have no idea how many scripts they issue. - How do you know they don't take Medicare? As an aside limiting Medicare patients is a survival tactic given Medicare rates - my endo doesn't take new Medicare patients, only those that were with him before they started Medicare. - I do think the barrier to entry for the protocol is low, but that's offset by the apparent unwillingness of anyone else to attempt this work given that we have seen no other publicity from clinics. - "Once endos become comfortable..." Any time scale for that? My bet would be not this side of a superiority trial at scale and with at least a six month duration. So right now VDEX looks pretty attractive. I was being facetious. VDEX has little impact on MNKD revenues. They have been around as long as MNKD has had a sales force (maybe longer) and the percentage is 5% vs 95% when it comes to Afrezza scripts. We don't know anything about what VDEX does. They are too cagey and only reveals what they want you to know. If they were on the level and want investor support they need to lay every thing out there. They want to attack MNKD (may I remind you it's a personal investor attack) for not explaining their strategy or marketing plan. Tell them to its time to PONY UP. I've had 2 friends go through VDEX's "PROTOCOL" and they felt like it was an insurance SCAM. They were going back 4 or 5 visits which they thought were unnecessary. They said 2 visits max was fine. Let's see how long insurance companies allow this. Mike has said this was going to be a slow rollout and it's proving out. This is a new therapy and we all know the behavior of diabetics. Another issue......MNKD vs VDEX - It's easier for diabetics to go to their Doctor vs a diabetics clinic which you really don't know it's a D Clinic bc they share an office with another company. But the point is that MOST patients are creatures of habit and takes a while for them to change therapies especially if they are having good control. You gain more coverage when you have 75-100 sales people around the country than you do with 5 clinics in a couple of states. But you know all of this....... Securing insurance coverage for poorly-tiered drugs basically involves proving results. Afrezza typically doesn't even get prescribed until the patient has had a few visits where they learn to use a CGM to monitor and understand how their body reacts to their present diabetes treatment... only then is Afrezza prescribed. Before and After data based upon recorded data can be much more convincing to insurers than to simply claim a lower A1c. I suspect that your two friends who allegedly told you they went through the VDex protocol are filling you with BS. As agedhippie points out, it takes time to go through the titration process. The idea of 2 visits max is laughable, IMO. |
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Post by mnholdem on Nov 23, 2019 17:32:29 GMT -5
I appreciate your reply, although I don’t see the label as a roadblock to successfully positioning Afrezza to capture a substantial share of the insulin market. I see the current business plan (which the CEO seems to change every six months) as the roadblock.
Regardless, I appreciate your thoughts.
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Post by mnholdem on Nov 23, 2019 15:04:31 GMT -5
To their credit, the Compensation Committee of the Board of Directors has revised executive compensation to be performance-based. The Board has communicated to shareholders that the performance standards are set sufficiently high as to require considerable effort by executives to achieve compensation for reaching those performance standards.
I think that it’s possible that Mr. Cooper will be valuable in assessing whether performance standards are too low, as well as providing guidance related to the 3-5 year business plan.
I hope Hooper is both aggressive and assertive largely because of the way I have implemented my business philosophy over 35 years in middle and executive management. I believe in pushing for paradigm changes. For example, if you set +10% as a goal, it’s quite likely that your managers will continue doing things the same way, only harder. If you set +200% as a near-term goal, you force management to think differently and, hopefully, to adopt a new paradigm with better results.
Technosphere Insulin is a breakthrough therapy for treatment of diabetes and it requires a completely different paradigm than conventional insulin treatments.
Insulin may be out of Mr. Hooper’s area of expertise but it’s my hope that he immediately recognizes the potential of Afrezza and brings his considerable expertise to help the company achieve the potential of its flagship product.
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Post by mnholdem on Nov 23, 2019 14:41:01 GMT -5
That wasn’t my intent, but I have do have firm convictions about what the roles of the Board of Directors should entail and what their priorities should be, including oversight of management’s performance related to the health of the company, the public image of the company and transparency by the Board to company shareholders.
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) will believe what they want which is what makes investing interesting.
