Send Message
View as an RSS Feed
  • More Products On The Way For MannKind?  [View article]
    A year for FDA approval, even with an existing drug, would be a phenomenal accomplishment. An exception might be a drug already approved for inhalation (asthma drugs), but then what would be the benefit of using Technosphere. Possibly 1-shot deals like vaccines would be something which could be fast tracked, but still it seems likely the FDA would require long testing, beginning with animals, and then progressing to humans. Seems intra-nasal delivery will be a competitor for TS, one which eliminates the possibility of lung damage and possibly the molecule size restrictions involved in TS delivery. Afrezza took what(?) 15 years to get through the FDA gauntlet...and it involves insulin vs some 'foreign' drug not already attuned and natural to the human body. I will be pleased but surprised if MNKD's TS delivery is approved for any other drug in under 3 years.
    Jun 6, 2015. 04:03 PM | Likes Like |Link to Comment
  • MannKind Corporation: Afrezza Is Better Than Weak Launch Suggests  [View article]
    Something to consider, especially in view of the recent warning about the potential dangers of SGLT2 (from memory) oral diabetes meds, is that Afrezza , without any serious side effects, appears to allow for discontinuation of oral meds with their list of potentially quite dangerous side effects....not to mention the potential cost savings of eliminating the oral meds.

    So possibly weigh the additional cost of Afrezza against the savings of eliminating costly oral meds; of course this will need to be weighed by each insurance provider and worked out with the prescribing physician as well.

    My guess though, is that as increasing evidence continues to indicate Afrezza's superior efficacy over ALL competitors, as well as the likely increase in compliance, that the insurance companies and physicians will eventually see the wisdom of 'paying up' for Afrezza.
    May 20, 2015. 12:44 PM | 2 Likes Like |Link to Comment
  • MannKind Corporation: Afrezza Is Better Than Weak Launch Suggests  [View article]
    For those truly interested and not yet aware - simply google 'afrezzauser blog' and you can see first-hand real-world before and after stats from 8 early Afrezza adopters; results indicate stunning improvements in BG levels and 'time-in-range' numbers - far in excess of what was demonstrated in the FDA's inflexible protocol approval trials.

    *Sam Finta 'afrezzauser' has an A1c reduction of from 10.2 'before Afrezza' to 6.5 with Afrezza, and Brian Sharp had a 10.1 A1c before Afrezza which dropped to 5.7 with Afrezza; btw 5.7 is considered non-diabetic!

    **Since Afrezza has only been available for going on 15 weeks, and a valid 'on Afrezza' A1c can't be performed for 90 days after beginning use - these A1c test results are just now beginning to accumulate; when it becomes evident, to prescribing physicians, that such phenomenal improvements are the norm...look for weekly avg. Afrezza scripts to increase significantly.

    Sanofi apparently has indicated the genuine 'hard' launch, the aggressive promotion which will include Direct to Consumer advertising will begin in early Q3 - so possibly by July...this time frame will allow for many more A1c results to have been received, as well as more complete physician education to have been accomplished.

    Afrezza's weekly scripts have been increasing over the last couple of months at above a 5% rate....without serious promotion by Sanofi - it seems logical that once serious promotion begins, that weekly average will increase, but even at 5.5% average weekly RX increase, Afrezza will reach approx. 1 million users in 3 years; that equates to approximately $2.4 billion to Sanofi, well into the 'blockbuster' category and likely resulting in a MNKD share price in excess of $25

    In all probability, once DTC promotion begins in July//August, the weekly RX increase will likely climb to at least 8% vs the current 5%; and then by 2017, or sometime therein, Afrezza sales will have begun in Europe and some South American countries as well...can availability in China abd India be far behind?
    May 19, 2015. 06:25 PM | 11 Likes Like |Link to Comment
  • Biotech Weekly: Small Cap Biotechs Under $1 Billion Market Cap To Watch Into ASCO 2015  [View article]
    Fair enough Daniel - ASCO it is....will be watching your picks and others, especially interested in ARNI as I haven't heard of it previously. You might want to put APHB and CRMD on your list for future research; thinking CRMD, though up sig. from the $2 area, and off the recent highs a good bit, is still a likely acquisition target.

    *BTW...MNKD is up ~ 20% in last 2 days.
    May 18, 2015. 05:29 PM | Likes Like |Link to Comment
  • Biotech Weekly: Small Cap Biotechs Under $1 Billion Market Cap To Watch Into ASCO 2015  [View article]
    *By the Way - 'woefully ignorant' isn't really a perjorative characterization...more an observation and statement of fact in this case.

    As mentioned, previously, Afrezza sales are averaging a 20% weekly increase through week 14 - this is impressive but likely not sustainable over the long haul....but it doesn't have to be since an average weekly increase of just 5.5% over 3 years will result in roughly 1 million users, just in the US; that 1 million prescriptions will generate roughly $2.4 billion in revenue - so well into and past the $1 billion revenue figure generally considered required to achieve the "blockbuster" status.

    Are you aware that Sanofi's stated "Initial" target for the US is 3.1 million users - and this was before there was such irrefutable evidence that Afrezza, in 'real-world' use was capable of achieving such stunning efficacy - efficacy far superior to what was achieved in the approval trials.

    By 2017 or therein, it is expected that Afrezza will be available in both Europe and South America, and I doubt China and India will be far behind.

    As the truth begins to get out regarding Afrezza's superior efficacy and safety, not to mention the elimination of multiple daily insulin injections, demand for Afrezza will very possibly outstrip MNKD's ability to supply it.

    *With the latest news of SGLT2 diabetes meds having yet another potentially serious side effect, it is even more likely that educated providers will be switching their patients to an alternate medication, which besides achieving superior BG control, also does so without any serious side effects whatsoever - in fact no side effects except the stated transient cough.

    It isn't rocket science Daniel - and you really should visit the sites I previously mentioned so as to educate yourself before trying to comment further on Afrezza and it's potential to reach blockbuster status.
    May 17, 2015. 06:37 PM | Likes Like |Link to Comment
  • Biotech Weekly: Small Cap Biotechs Under $1 Billion Market Cap To Watch Into ASCO 2015  [View article]
    Sorry you fail to 'appreciate' my characterization - the truth can hurt at times; and again, you comment without requisite knowledge or research.

    My comment was regarding your claim that Afrezza will not reach 'blockbuster' status - you are wrong on that, and you are also now wrong about the convertible since Mathew Pfeffer just mentioned at the recent CC that he absolutely will NOT dilute for the Aug. $100M convertible.

    Something else to consider is that the Sanofi launch also includes a 1 month sample of Afrezza, of which approx. 54,000 have been distributed to date...these do not require a prescription. So it is easy to see how the RX figures to date could easily fail to reflect genuine demand.

    Sales of Afrezza thru week 14 is averaging about 20% weekly increase, and that is with a limited promotional campaign - when one considers that it can take 2 to 3 months just to get an appointment with many Endos, your so-called 'extremely slow' sales is nothing of the sort.

    You actually are displaying what appears to be a pattern of failure to do proper DD before answering questions as if you know what you are talking about.
    May 17, 2015. 05:46 PM | Likes Like |Link to Comment
  • Biotech Weekly: Small Cap Biotechs Under $1 Billion Market Cap To Watch Into ASCO 2015  [View article]
    You are woefully ignorant if you think Afrezza won't be a muti-blockbuster. Afrezza has only been on the market for roughly 14 weeks, and Sanofi has engaged in a limited 'soft' launch to date - the aggressive promotion, which will include DTC ads, is not really scheduled until early Q3.

    As regards efficacy - show me ANY other diabetes medication which can reduce A1c results as drastically as Afrezza....Nothing even comes close, and that with no side effects but a transient cough in roughly 40% of users.

    As more of these irrefutable A1c results from early adopters accumulate, along with DTC advertising, you will see a huge increase in demand for Afrezza.

    Do yourself and those who follow you a favor and research the Afrezza report by Amy Tenderich, editor at DiabetesMine...once a skeptic, now an outright advocate as she can hardly believe the superior BG control and increased 'time-in-range' Afrezza has allowed her - all without multiple daily injections as well. Or you could just google 'afrezzauser blog' and read of the phenomenal results being recorded by a group of early Afrezza adopters. You might also educate yourself on the accumulating short interest and check out the latest Afrezza note by Jefferies' analyst Shaunak Deepak. Of course you could also just follow the lead of Nate Pile and accumulate - you do know who Nate Pile is right?

    *See, in real-world use, use unencumbered by absurd FDA trial protocols, Afrezza is proving to be far far superior to the misleading 'non-inferior' endpoint achieved in the approval would know that if you did proper DD previous to responding to a question regarding Afrezza; never too late though.
    May 17, 2015. 12:06 AM | 1 Like Like |Link to Comment
  • Afrezza Officially 'Unofficially' Hits $1 Million In Sales  [View article]
    Actually the Reward potential seems much better for MNKD.

    Keep in mind that MNKD lost about $200M last year, and has already received at least $200M in milestone payments to date, not sure what the next milestone qualifier is. Assuming milestones meet or even exceed total operating expenses, any sales of Afrezza likely go straight to profit.

    The MNKD script chart at InvestorsHub has MNKD scripts increasing at an avg. 23% for the first 13 weeks of sales with 2223 written as of 4/24 (avg. retail script cost of $457)....assuming this drops to 16% going forward, Afrezza scripts would reach 100,000 at about the end of Q12016, or beginning of Q2. Last weekly RX #s only increased at 8%, with some recent weeks indicating flat or neg. increases, so an argument can be made that 16% is too high, but keep in mind Afrezza sales to date have been achieved without any serious promotional campaign...the 'hard' launch with DTC ads is not expected until Aug. or Sept. With further milestone payments in 2015 or some additional upfront cash from TS collaborations MNKD could achieve profitability much sooner than might first be expected. Wondering if another $200M in milestones will follow in 2016 as well.
    May 4, 2015. 11:54 AM | 4 Likes Like |Link to Comment
  • MannKind Corporation: A Good Risk/Reward Play For The Long Haul  [View article]
    First off Steve, there is no lung safety issue, or the FDA wouldn't have approved Afrezza; however, last I checked there are a whole slew of known safety issues with oral diabetes meds, not to mention the known health issues arising from poorly controlled BG arising from Diabetes.

    My understanding is that a sig. greater percentage of prandial insulin injectors greatly dislike their need to inject themselves 3 or 4 times per day than the 10 to 15 percent you mention in your article; besides, instead of asking how many "fear" their injections, were one to ask how many would jump at the chance to eliminate the need to inject in favor of an equally effective inhalable prandial insulin...I have no doubt the percentage of affirmative answers would greatly increase. And btw, reports from early Afrezza adopters are indicating that not only is Afrezza safer, but it is proving, in real world use (not hindered by rigid trial protocols), to be far more effective than what was demonstrated in the approval trials; you would know that had you done some proper due diligence.

    Why don't you do some after the fact investigation and look into the first-hand report of Afrezza by Amy Tenderich, the editor of DiabetesMine (she was a skeptic at first, but now has become an outright advocate as she can hardly believe the superior BG control and 'time in range', over all other RAA insulin, which Afrezza has allowed her to achieve).

    As regards superior safety maybe this reported quote regarding Afrezza by Dr. S. Edelman of UC San Diego, a lead investigator in the Afrezza approval trials, will be enlightening: "I can say it has been shown in clinical trials to reduce hypoglycemia, but FDA won’t let (Sanofi) put that in the labeling. I was at the FDA public hearing in Washington, DC, and they spent all the time trying to refute the data instead of trying to understand it… It’s just a total shame FDA didn’t allow them to put that benefit in the label."

    Considering the ever growing reports by early Afrezza adopters of both astoundingly superior safety and efficacy, it is my view that Afrezza will indeed be a blockbuster treatment and a game changer for all insulin supplementing diabetics who give it a try....the reports are that good!

    Apr 25, 2015. 12:06 AM | 23 Likes Like |Link to Comment
  • MannKind Corporation: A Good Risk/Reward Play For The Long Haul  [View article]
    You only have Al to 'blame' for the ridiculously high compensation; of course the adjective of choice chosen by MNKD mngt. would more likely be 'thank' than blame. Now if he would just demonstrate a similar concern for the company's actual share price, or any concern whatsoever, we all might be happier campers. Oh there I go slipping into that hyper-critical mode again.
    Apr 24, 2015. 10:58 PM | 8 Likes Like |Link to Comment
  • MannKind Valuation Scenarios  [View article]
    First off a P/S multiple of 8 seems oddly and unrealistically low - why not utilize a P/S multiple of say 16ish, similar to that of REGN, or maybe the 27ish P/S multiple of PCYC, or even the 36ish P/S multiple which ISIS is sporting? Anyway - it's your model, but it of course makes a huge difference.

    Also, as you are likely aware, or should be, the reports beginning to accumulate from early Afrezza adopters indicate efficacy far surpassing what was achieved in the recent approval trials, not to mention superior safety (as one has to really try to get a hypo while using Afrezza), and superior convenience (translate that as increased compliance); afrezzauser (Sam Finta...Afrezza trial participant and AdCom Speaker) and others are reporting non-diabetic BG levels and 'time within range' numbers which they never have achieved previously. So considering this amazing efficacy, it seems reasonably logical that Afrezza could easily capture 60% of the existing RAA market in the US and Europe within 4 or 5 years, let alone 8 years; then there is the Asian market as well.

    Honestly, what percentage of people (except those medically contraindicated) will choose to continue forcing a metal shaft into their flesh 3 or 4 times per day when there is a superior product available which doesn't require it? And for any who would argue whether Afrezza is superior in efficacy and safety - don't bother as you will just look foolish or biased.

    So 60% of a global market which is increasing at roughly 7% annually (some studies indicate RAA adoption is outpacing diabetes incidence significantly) seems quite achievable.

    Still....appreciate the effort you put into this article.
    Mar 31, 2015. 07:18 PM | 6 Likes Like |Link to Comment
  • MannKind Valuation Scenarios  [View article]
    Of course one has to keep in mind that "currently" a large percentage of the diagnosed US diabetics aren't utilizing insulin (though many more 'should' be than are). And then of course there is the huge 'pre-diabetic' US market which apparently numbers in excess of 80 million - time will tell on that front.

    Considering Afrezza's potential and ascribing some value to the underlying TS platform, a P/E metric of 35 seems justifiable, though I prefer using the P/S metric.

    REGN is currently sporting a P/E of 35ish, and PCYC is currently at a Forward P/E of 59ish, so there is indeed precedence for using a sig. higher P/E than 20.

    Also, considering the astounding reports, from early adopters, of Afrezza's superior efficacy and safety, not to mention convenience (translate that to increased compliance), it seems quite logical that Afrezza could easily capture 60% of the US RAA market; in 'real-world' use, Afrezza IS
    proving superior to any RAA competition, regardless of what the recent trials indicated - that fact will become ever more evident as early adopters begin turning in their latest A1C test results (new users must be on Afrezza at least 12 weeks before they can test accurately).

    *Note that Sanofi, previously has gone on record indicating that their "initial" target for US Afrezza adoption is roughly 3 million users; one should be able to assume at least an equal amount of 'initial' users from Europe as well....granted Afrezza may not be available in Europe 2016/2017.
    Mar 31, 2015. 06:19 PM | 3 Likes Like |Link to Comment
  • MannKind Stock Approaching Pre-FDA Approval Price: Is A Bottom Coming?  [View article]
    "Since AL went out of his way to make retail investors believe that the Pfizer insulin was a hugh liquid asset, post approval, and it is not; he should personally take an interest in fixing the capital structure before he fully disengages from the company."

    Agreed, without question - also, without question, don't hold your breath.
    Mar 28, 2015. 01:37 PM | Likes Like |Link to Comment
  • Forget Biased Analysts, Diabetics Love MannKind's Afrezza  [View article]
    Here is a recent (3/2/15) Twitter comment from Brian Sharp, a pilot and T1 diabetic, representative of many Afrezza 'early adopters' experiences which are popping up on Twitter, other social media sites, and diabetic groups: "My 7 day average is 119.4, the lowest I had in 16 years! Go Afrezza! Yesterdays average was 94.6, You can super control your BG with Afrezza"

    Such reports indicating Afrezza efficacy far surpassing that achieved in the FDA approval trials, and indicating quite superior efficacy to any other competing RAA available, are quickly finding their way back to the prescribing Endos and PCPs as well; soon it will be hard to find a doubting Endo.

    Soon this initial trickle of reports, will become a stream, then a flood...Afrezza will then be in such demand I wonder if MNKD will be able to produce it fast enough. Imagine a painless, vastly superior alternative to the 'buggy whip' barbarity of jabbing metal shafts into one's belly 3 or 4 times per day - wait, you don't have to imagine it since it is already available.
    Mar 3, 2015. 08:05 PM | 6 Likes Like |Link to Comment
  • MannKind Is Tripling Production To Meet Future Demand  [View article]
    Thanks for your input doc - very valuable.
    Feb 26, 2015. 09:09 AM | 1 Like Like |Link to Comment