MannKind: Playing Poker In A High Stakes Game Holding A Busted Flush Hand

Summary

• Latest prescriptions data will be shared with my readers.
• I will respectfully give my opinion that is contrary to another SA contributor's latest article.
• Technosphere continues to be an antiquated technology that hasn't made other drug companies worry about MannKind's patents on their inhaled technology. They continue to develop and get FDA approvals.

(The Poker Player with All the Chips is Calling MannKind's All-In Busted Flush Hand)

The purpose of this article is designed to be respectful of the numerous articles that another SA contributor has made about MannKind (NASDAQ:MNKD). Spencer Osborne has played a major role in creating charts and sharing data that outline the issues that MannKind faces and will continue to face. Many of those who truly believe that Afrezza will be a paradigm change for how we treat the horrible disease of diabetes, in my opinion, will be sorely disappointed. Mr. Osborne's articles have given investors a clear picture of the critical data that proves MannKind is approaching just the next binary event outlining their clear need for another infusion of cash. A need where it will be necessary once again to dilute shareholders' investment in MannKind's stock.

In his latest article, he makes valid use of his detailed and creative charts and graphs. However, I respectfully disagree with some of the issues stated within the article and subsequent comments section about the potential of partnership deals and where they will come from.

But first an update on where MannKind currently stands:

First Q-2018 Results with One Week's Data to Collect:

Now into the fourth calendar year experiment in convincing doctors, patients and third-party payors adopting the use of Afrezza, we see the quarterly results now having one week left in the 1^st Q-2018. Twelve weeks into the quarter we see total prescriptions falling below the last 12 weeks of 2017. Unless Afrezza prescription breaks above 600 total prescriptions in this last week of reporting, quarterly sequential growth will show a decline in prescriptions.

2017 Growth Pattern Per Quarter:
	TRXs	%+ or -
1stQ:	3,203
2ndQ:	3,507	9.49%
3rdQ:	4,875	39.00%
4thQ:	5,705	17.00%
Last 12
Wks.2017	5,300
First 12
WKs.2018	5,098	-3.80%

Click to enlarge

Tracking the last 28 weeks, all the way back to September 17, 2017, we see that New Prescriptions currently show the cumulative total of such prescriptions hasn't shown any growth. In fact, the New Prescriptions data show negative cumulative numbers for this vital data point needed to generate sustainable revenues. The fact is we have seen three separate launches of Afrezza. with two of these launches under the total control of MannKind-led efforts based on their initial promise they would prove how wrong Sanofi's (SNY) efforts were conducted and being such a dismal failure. In addition, they stated they would be able to do it with less operating funds and fewer sales representatives than Sanofi used in their efforts. The fact being in their last quarterly report MannKind's financials indicated they spent over $30 million dollars, their highest rate of spending since the product was launched.

Growth Pattern for Afrezza Prescriptions:
	TRxs	NRxs	Week+/-	Cum.Tot.
9/17/2017	428	244
2	417	245	1	1
3	442	254	9	10
4	409	225	-29	-19
5	404	209	-16	-35
6	412	247	38	3
7	446	267	20	23
8	440	247	-20	3
9	449	253	6	9
10	486	270	17	26
11	360	199	-71	-45
12	474	247	48	3
13	470	251	4	7
14	481	256	5	12
15	502	295	39	51
16	370	183	-112	-41
17	345	160	-23	-64
18	419	229	69	5
19	380	185	-44	-39
20	429	246	61	22
21	423	238	-8	13
22	424	227	-11	2
23	448	222	-5	-3
24	446	232	10	7
25	449	227	-5	2
26	389	196	-31	-29
27	452	207	11	-18
28	494	209	2	-16
Total:	12,088	6,470
Wk.Avg.	431	231

Click to enlarge

In the final quarter of 2017, their executives apparently decided to go 'all-in' with the small amount of cash they had in the till because they had a new label change that would open the doors to prosperity. In addition, they decided to spend $5 million in TV ads in major markets and on critically acclaimed television shows. This was a follow-up to a cable TV program dedicated to diabetes that MannKind personally sponsored. What is amazing about this 'all-in' spending on TV ads is at the same time the major drug companies were cutting their TV ad budget by millions of dollars - leaving MannKind's executives once again going against the decisions made by big and successful pharmaceutical companies. First it was Sanofi pulling in their marketing budget for Afrezza, but MannKind bulling ahead with assurances they would be successful against the long odds. This was in 2015, and now going into 2018, once again we see the efforts from this $30 million was wasted money. They have proven they can't market Afrezza any better than Sanofi. At this point in time, inhaled insulin has been a failure for Pfizer, Sanofi. Now MannKind's efforts are the worst of the three companies having tried to sell inhaled insulin to patients and doctors.

As I write this article, it's March 31, 2018, the last day of the 1^st quarter, 2018. Probably at 12:00 p.m. in California, MannKind's financials will indicate they have broken the covenants of their loan agreements. With the lack of cash to honor their bills, I truly find it ironic that MannKind's CEO is flying to Europe. Monaco to be exact! A gambling mecca where he will attend a financial conference being conducted by what many might consider the last bastion of financing hope for a company desperate for loans.

H.C. Wainwright admits they are -"H.C. Wainwright's team is ranked as the #1 Placement Agent in terms of aggregate PIPE and RD transactions cumulatively since 1998." If an investor isn't knowledgeable about PIPE transactions, just know they are normally used by companies that are desperate for cash. And one can't argue the fact that MannKind is desperate for cash.

I just find it odd! MannKind once had all the major Wall Street investment firms following and reporting on every tidbit of information being generated by the company. Now on their CCs none of them are still around or showing any interest in the company. With cash so tight for the company, why would a CEO fly to a European gambling mecca seeking funding? All I can say, the CEO better win at least at the Black Jack tables, because now he holds a busted flush with his high card being an eight.

I Beg to Differ with Mr. Osborne's Last MannKind Article on Certain Points:

In his last article, his charts, graphs, and projections of various data points are spot-on for revealing pertinent information that normal investors should pay heed to what they reveal. However, it's the following statement in the body of his article and later him expounding on this point in the Comment Section of the article that I have a problem with.

I estimate that unless a move is made, MannKind will be out of cash prior to the end of Q2. This means that some form of capital infusion is needed in the near term. In my opinion, it will get a small injection ($10 million to $20 million) from a proposed international deal that is in the term sheet phase but management indicates will happen in Q2. This would still mean that dilution will be required."

Later in the comments section he responds to another person's question about where this international deal might come from -

I suspect that the first step will be somewhere in the Middle East. It is the least complicated for a few reasons.

1. It is not a huge market, so it does not take too much away from the possibility of a big partner wanting multiple countries or regions.

2. It will not be a region that includes China, because Amphastar has right of first refusal on China."

Quickly another MannKind investor followed up with this comment-

Deals with Saudi/UAE's will be better than deal with many larger countries at this point. These small countries spent a lot more on health care/prescription drugs than China, India, etc."

My Rebuttal:

First, let me correct the assumption by the latter MannKind true believer who believes that Saudi Arabia spends more on healthcare than China. I've added the United States in my response to this person's ill-advised claim:

• Saudi Arabia spends 4.7% of their GDP on healthcare - Latest GDP for the Saudi's - $708.796 billion
• China spends 5.5% of their GDP for healthcare - their latest GDP was a mere $13,118.690 trillion.
• United States spends 17.1% of our GDP - Latest GDP is running at $20,199.960 trillion.

Just like most European countries, the Middle East nations have joined together as a consortium when it comes to dealing with their healthcare system needs. Saudi Arabia is the leader of this effort, and sets the standards for their respective programs.

Saudi Arabia has a very active medical community made up by some of the best trained medical physicians in the world within their healthcare system. They even have a highly respected medical journal that screens medical research and subsequently publishes detailed journal articles. This source for the medical community is highly relevant information for such professional caregivers. The following is a basic outline of their healthcare standards and how they are paid by Saudi Arabia -

In Saudi Arabia, the provision of health care is dominated by public-sector providers, primarily the Ministry of Health (MOH). The government plays a central role in providing healthcare services, accounting perspective for about 75% of the total healthcare spending in the country. The pharmaceutical market remains reliant on pharmaceutical imports, particularly for high-tech patented drugs. In addition, the market is highly regulated, given that the MOH, previously did not, and currently, the Saudi Food and Drug Authority (Saudi FDA) does not allow the sale of any pharmaceutical product that has not met the country's licensing requirement. In addition, the Saudi FDA has strict price control policies in place to limit both public and private spending on branded, generic and over-the-counter (OTC) pharmaceuticals. The forecast is that total pharmaceutical spending in Saudi Arabia will increase from $2.65 billion in 2008 to $3.68 billion by 2013, representing a compound annual growth rate of 6.8% in US dollar terms. The main driver for such growth is thought to be the increasing burden of respiratory diseases in the country, along with diabetes, hypertension and cancer. Furthermore, the Saudi Arabian government has recognized that the population is projected to increase to 27.6 million people by 2013 and has admitted that it is challenging to finance a sustainable healthcare sector."

What are the Issues:

Let's step back and look at the issue up for debate. The Saudi government through their MOH pays for 75% of their healthcare spending. So, who would make up the 25% left for consideration? We know historically, these petroleum-rich Middle Eastern nations import all their manual laborers and house-hold servants, etc. Therefore, I think it a safe assumption these non-Saudi citizens would not be covered under their MOH system. We also know the pay scale for these non-Saudi citizens is low paying jobs.

• We now know, according to this Saudi medical journal, the healthcare market is highly regulated.
• Saudi Arabia has strict price control, especially for branded drugs.
• If an individual residing in Saudi Arabia and they aren't getting coverage under their national healthcare program MOH, why would anyone think these individuals have discretionary funds to purchase the world's most expensive insulin-based product on the market?

What does this mean for Afrezza?

• With the Saudi government covering 75% all healthcare expenses in their nation, and set the standard for other Middle East nations, which Middle Eastern government or partner, in their right mind, would offer MannKind an upfront payment of $20 million when all they would have to do is order the drug directly from MannKind. The MOH leaders aren't stupid people, the Saudi government is cracking down on their healthcare cost structure. The price they pay for drugs is at the top of their list.
• Does anyone think that Saudi Arabia will remove their strict price control policies for Afrezza?
• Afrezza would have to undergo a strict licensing requirement in Saudi Arabia. The very first thing that Saudi Arabian medical professionals admit is their largest medical concern deals with respiratory diseases. Just this issue alone and the clear fact that here in the United States, the two issues preventing any growth in the initial uptake and then the refill disaster are cost and adverse events impacting their respiratory system. Does any MannKind true believer think that Saudi doctors aren't aware there are major medical issues that impede Afrezza adoption by patients relates to the requirement their patients would have to undergo spirometry testing?

After all the claims made for years that Afrezza would be submitted for European approval (remember-Exubera was approved in Europe before it was approved in the US) there is no talk about MannKind having plans to submit their product for European approval, anytime soon. Now the speculation is shifting to the Middle Eastern nations. Where with some basic due diligence, investors would understand breaking into this market would be the most difficult market in the world to peddle Afrezza. Let's not forget, MannKind has already tipped their hand - the only "potential" partnership that has been openly discussed is with Brazil. And this deal didn't involve one cent of upfront payments being made by the partner who isn't exactly one of the most reputable operations in Latin America.

Truly amazing there would be anyone thinking with the Saudis having probably the strictest criteria for approving a medication for use in their nation, and then add they also have the strictest price control and the true believers think the leadership team for the MOH is going to allow Afrezza being approved for use in their country and thus exacerbate the #1 health issue they face - respiratory problems.

Last Article I Wrote About Afrezza:

In my previous article I went into details outlining the manufacturing issues MannKind faces with the production of Afrezza. Let me once again highlight the nature of the White Elephant facility that MannKind has in Danbury, Connecticut.

• MannKind's Technosphere has been around for at least two decades.
• Technosphere, for two decades, MannKind has sought partnership deals using their product. This would make Technosphere probably the most reviewed delivery system in the history of medical development. Now twenty years for the product being reviewed, there has never been one meaningful partner secured that has led to a FDA-approved clinical trial.
• As stated in my previous article, the Technosphere technology obviously has issues that have prevented other large pharmaceutical companies from using Technosphere. This lack of use by others hasn't prevented the massive growth in inhaled products coming onto the market, approved by the FDA.
• As pointed out in my previous article, over the last four years there has been 1,350 active inhalation clinic trials. This fact alone proves that with all the patent claims made by MannKind about their inhalation technology, NOT one other company hasn't been stopped from infringing on MannKind's patents. Simply meaning, they are worthless patents, or at least patents that other drug development companies care 'one iota' about them.
• The mere fact that MannKind makes great claims about their patents, the previously stated fact of growth in inhaled products, this massive growth hasn't and will not be impeded by all the patents MannKind claims they have for Technosphere.
• Let me repeat one more time - Technosphere and the antiquated process that it entails in making a finished insulin product - Afrezza - involves massive mixing vats, a drug-wetting process, massive ovens to dry the products, and then throw in the excessive packaging requirements with the inhaler and numerous individual packets of various doses of the product. This makes Afrezza the most expensive insulin product on the market. Therefore, all the other major insulin marketing pharmaceutical companies will always be able to beat MannKind's cost of production. All MannKind's competitors are lowering their cost of product, and now we have the true believers thinking Saudi Arabia is going to be their white knight in shining armor. So let me remind those who believe this scenario, throw these new issues into Afrezza being the most expensive insulin product. If Saudi Arabia should opt to cut a deal for Afrezza use in their country - MannKind or the 'partnership' would have to add the shipping cost of the product from Danbury - add on the additional cost of the special packaging that Saudi Arabia REQUIRES on all drugs marketed in their country with each separate item having Saudi special codes on each of them.
• Look at the gross revenue numbers that MannKind is currently generating with Afrezza sales in the United States. Now look at the net revenue generated for the most expensive insulin on the market. And one will now think that Saudi Arabia will never agree to this price, add in the additional cost related just to Saudi Arabia, and the paltry net revenues in the United States will be totally exacerbated by the revenue being generated in Saudi Arabia.

One simple question - why would anyone expect a Saudi Arabia partnership to hand over $20,000,000 to MannKind in an upfront payment? The only thing MannKind could hope for is to find a wholesaler to take on distrusting Afrezza in Saudi Arabia. But once again that is the problem!

The United States spends 17.1 % of their GDP ($20,199.960 trillion) for medical care expenses. Saudi Arabia spends 4.7% of their GDP (708.796 billion) for medical care expenses. The reality of such comparisons, MannKind can't find a partner in the United States, they can't for a wholesaler willing to take on the distribution of Afrezza. But Saudi Arabia is 'chomping at the bit' to continue the 'next greatest' fool theory is going to save those invested in MannKind's stock? Not hardly!

Final Point:

In 2015, 2016, and 2017 the true believers were quick to state that the lack of refills wasn't important, the only thing that counted was the growth in new prescriptions. Now that we see new prescriptions are running less than half of the rate in those early years, now they've shifted their claim that it's only the refill data that counts. Apparently forgetting that refills are always predicated on new prescriptions that are then compounded to make a company profitable! That magic word that, in my opinion, MannKind will never see - profitability.

In the 3^rd Quarter of 2015, Sanofi generated 6,667 prescriptions with Afrezza. With this final week of the 1^st quarter of 2018, MannKind has achieved 5,098 prescriptions with their efforts. Go back three years and compare results for now - the 4th calendar year that MannKind has promised stellar results. This Friday, unless by some miracle, if MannKind doesn't show 1,569 prescriptions for the week, they have failed in their stated goal. Never forget - Sanofi opted to wipe their hands off Afrezza due to it being a lost cause. Why would MannKind think anything different? When the money runs out - the CEO can't expect free expense paid trips to Monaco!

Conclusion:

It has always been my hope and desire that Afrezza will remain available for those patients that need options for treating their medical condition. Afrezza is insulin, and for decades we have known that insulin is beneficial for treating diabetes. The simple issues as they relate to Afrezza - with its cost and efficacy issues, where even MannKind executives have stated exist, can Afrezza ever turn a profit for MannKind?

Though I disagree with some of Spencer Osborne's positions in his latest article, going forward I would suggest all investors should pay attention to his detailed charts, graphs and projections. As always, they offer valid information that helps one doing due diligence on the involved company.

Good luck with your future investing decisions!

Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Comments

[Looking For Diogenes]

Stock is down to $0.33 per share based on pre-reverse split. Kastanes thinks he sees ship laden with gold pulling into his dock!! Maybe tomorrow!

[what3sixteen]

MNKD shareholders have been holding a 32 offsuit on a A K10 7 4 rainbow board, and think they have a straight...

[Looking For Diogenes]

What a deal! Boy can MNKD skin a cat more than one way. Suckers can buy this $2.00 offering and automatically be $3.40 in the hole in the stock's valuation. And there is no guarantee that the underwriter can do the deal for the full 14,000,000 shares. Typical MNKD cat skinning endeavor.

"You will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase.
Since the price per share of our common stock being offered is substantially higher than the net tangible book deficit per share of our common stock, you will suffer immediate and substantial dilution in the net tangible book value of the common stock you purchase in this offering. As of December 31, 2017, our net tangible book deficit was approximately $(214.7) million, or $(1.80) per share. Based on the combined offering price of $2.00 per share of common stock and accompanying warrant offered hereby, and our net tangible book deficit as of December 31, 2017, if you purchase securities in this offering, you will suffer immediate and substantial dilution of $3.42 per share with respect to the net tangible book value of the common stock. "

[RisingSKEPTIC]

"What a deal!"???

Speaking of a deal, did you notice in the golden parachute section of the 14A the provision for health insurance costs:

"Continuing health and welfare benefits(1)...

...(1) Represents the estimated cost of providing or paying for continuing medical and dental coverage for 18 months. The amounts for medical and dental insurance coverage are based on rates charged to our employees for post-employment coverage provided in accordance with the Consolidated Omnibus Reconciliation Act of 1985, or COBRA."

For those with the parachute, that number is between 40 and 50 THOUSAND dollars awarded to provide 18 MONTHS of coverage.

For THAT amount of money, I could cover a family of four for three YEARS with an obamacare GOLD plan.

[matese16]

Diogenes, and it never ends. Year after year it's the same excuses. This holiday, that event, this hope, that deal. Meanwhile, the only meaningful deal which was SNY, and, I thought that deal was terrible when announced - and that lasted all of about 18 months. Of course, it's because of the new CEO. Cant' be that they saw the writing on the wall. I like watching zombie movies but mnkd takes the cake and blows the walking dead right out of the water.

[User 47525423]

Get with it Rising-

What are sales?

[Looking For Diogenes]

Mate,
The classic example of how irrational the true believers see things, on their highly censored Proboard where on dare not make a negative comment, they are now blaming Good Friday for causing the dismal prescriptions data.

[matese16]

It's the same story repeating itself over and over. And yet the true believers still say things like "just wait a few more months", and "this dilution doesn't matter". lol.....Anyone who is still holding shares purchased from the time of FDA approval is sooooo diluted right now. Glad I dumped this company when I did. What a nightmare! When this company's SP goes sub a buck, again, they won't be able to dilute themselves to profitability as some idiot posters believe. Who was it? Adam F from thestreet that called it "death spiral financing"? And he was attacked over and over for saying it. Meanwhile, a few years later - that's exactly what's been playing out. Death spiral financing. I can hear the slurping around the drain. Meanwhile, mnkd management continues to spin their "good news" and the rabble eats it up like it's steak and lobster. Sorry folks, you've been fed gruel.

[Looking For Diogenes]

Stock is down 25% today and the CEO comes back from Monaco sporting a nice tan and more money in the till to spend for insider's huge salaries and bonuses for their good work. The believers on Proboard---once again spinning their glee over how savvy their CEO is and moving out their ship docking with their gold---all until TOMORROW.

The CEO brags about more than doubling the net revenue in 2018 from 2017. Doubling! And now with the 1st Q, 2018, they have a sequential quarterly growth in the negative from the previous Q---1/3 of the year gone---so guess what they will now need over the remaining month to see a double in net revenue---! My TI calculator can't even handle such a massive number. Bless those pure True Believers who think if they could only hold on until Tomorrow. Their day will come!

[Looking For Diogenes]

This is how desperate MNKD finds themselves.On October 11, 2017, they pumped the stock to $6.96 and got off a secondary for 10,166,000 shares at $6.00.

Now a mere 5 months later they forced to issue another offering--but this time they could pump the shares like they did in October. This time they were forced to increase the offering by 40% more shares and are getting only $2.00 for these shares.
The suckers from the October offering are now suffering a loss of 67% of their investment dollars.
Those foolish enough to once again feed the kitty, with this latest offering--stock is down more than 22% today.

But guess who is making money--the deal makers who short the heck out of the stock like the October deal @$6,00. Those 10,000,000 shares have allowed them to make $40,000,000 merely buy shorting high and cover their short position with one more offering.

Problem is--without the ability to pump the shares--they are now down to $2.00 offering-------slowly, but surely, the money source is dwindling. Look at the reality--October it was 10,000,000 shares to generate $61 million---five months later the $61 million has been spent. The latest it takes 40% more shares, but they are only generating $28m. So with the obvious burn rate--$60 million in 5 months---this current $28 million will be spent by July.

Wake up True Believers---Take off your rose colored glasses!

[RisingSKEPTIC]

It's funny! Proboards opening page has a little strip with changing mottos. The latest is:

"''You can avoid reality, but you cannot avoid the consequences of avoiding reality.'

Ayn Rand"

How many times have Mannkind shareholders had to learn THAT lesson!

[Looking For Diogenes]

The CEO revealed his busted hand last night and now the True Believers once again get spanked as MNKD trading below $2.00. Down and Down They Go! Below $1.00 within months and then another reverse split! OUCH! When Will They Ever Learn?

[nitrousoxide]

Every dog has his day.

[A doc]

“not one hasn’t” where i went to school that means one has. “go figure”

[Tugman]

May $10 Calls. Anyone?

[Looking For Diogenes]

Let me attempt to simplify the issue about Technosphere being an antiquated technology that has become a White Elephant product. MNKD’s 20-year attempt to make a deal with any other partnership deal has never happened for a simple reason—the process used by MNKD is the most expense process in the market place. With growing use of price controls, drug manufacturers are seeking ways to control their cost. As part of this solution new technology and manufacturing methods have been developed.
I cite the fact about 1,350 inhalation based clinical trials have been initiated over the last four years and none of these trials other than MNKD self-directed efforts has used Technosphere. The core reason is the fact that other companies have developed more cost-effective manufacturing processes and none of them infringe on the vast number of patents that MNKD boast about. One more time—MNKD’s patents are worthless, because there are parties interested in them.
The science of the dated process of drug wetting in the production drugs is complex. However, if one wants to read the massive number of research articles that have been compiled over the last two decades—simply Google the term—drug wetting process.
In one simple explanation of what is involved in this process—the following are laymen terms of the elaborate and costly process:
“Wet granulation is a process of drying mixing, wet mixing, and particle size enlargement and is a process of particle attachment(agglomerati...
It consists of six steps:
1) Dry Mixing
2) Wet Mixing
3) Milling of the Wetted Mass
4) Drying
5) Milling of the Dried Mass
6) Final blending

This is a link for the Liquidia Clinical Trial where if you read in deal you will see that Liquidia is using a Non-Wetting Process in making their Phase 3 treprostinil trials.
http://bit.ly/2Gxaipl
Look under the section –Detailed Description and you will find the following claim-
“Liquidia is using Liquidia’s PRINT technology (Particle Replication in Non-Wetting Templates) PRINT.
I’ve shared all the mixing vats and oven used by MNKD—this makes the Danbury plant a White Elephant because it uses outdated methods used for making a dry powder medication. Please understand—Technosphere’s process makes it a process that will always make their product the most expensive manufacture. This is why no one has opted to use their delivery system—and that being over 20 years of rejection. All their claimed patents aren’t worth a plugged nickel!

[RisingSKEPTIC]

Speaking of patents not "worth a plug nickel," does anyone recall how the "forlorn hope" of Mannkind used to plug Mannkind's deal with Mintaka Foundation to develop an inhaled oxytocin:

http://bit.ly/2GymhmF

"Heat-Stable Dry Powder Oxytocin Formulations for Delivery by Oral Inhalation"

However, that appears to have gone down in the same flames as the promised TS-epinephrine!

MEANWHILE, back at the ranch, Glaxo/Smith/Kline has its OWN dry powder oxytocin formulation working its way through phase TWO:

http://bit.ly/2uMaFqJ

"Increasing Access to Oxytocin for the Prevention of Postpartum Hemorrhage"

The thing I found MOST interesting is that they just use their true ANTIQUE "rotohaler" device to deliver the drug and, apparently, it works just FINE! AND it DOESN'T need FDKP! Go FIGURE!

Even MORE interesting is this recent review of all the dry powder inhalers:

http://bit.ly/2H9lu8Q

Wow! There's a BUNCH of'em, isn't there! But guess who ISN'T on the list! That's right! Not word ONE about "dreamboat" or "cricket" or afrezza or Mannkind! Go figure!

Even BETTER, published only a couple of MONTHS ago, this guy practically GUSHES enthusiasm over dry powder inhaled meds:

http://bit.ly/2uQ0Vff

"Imagine the Superiority of Dry Powder Inhalers from Carrier Engineering"

Oh, my:

"At last, this continued advancement will benefit clinicians and patients, allowing easy delivery of various therapeutic agents as dry powder inhalers with improved in vivo efficacy, better patient adherence, and reduced adverse effects."

But not ONE word about FDKP! Not ONE word about afrezza! Not ONE word about Mannkind!

Think maybe there's a HINT in there someplace?

[RisingSKEPTIC]

Addendum -- the first link to "Review of Dry Powder Inhaler Devices" may not work because it's to some sort of secure server, but if you're interested, you still can google "american pharmaceutical review Review-of-Dry-Powder-I... and that will take you there.

[harshad31]

Product is great. Mgmt should align with sale numbers with a payroll.

[4bama1139]

Interesting article. There’s always 3 sides to every story or opposing opinions and I don’t necessarily disagree with the article cause sales are sales and sales have not ramped up like I prefer to see.

However I used to hear the similar arguments when Sirius and/or XM when they delayed launch of business or had to raise funds to launch new satellites. At least a quarter billion at a time roughly to launch new birds.

The money was always raised whether debt or stock offering. Will be no different with mnkd when needed. The question is at what cost and how much stock dilution or could they work out a more generous debt offering with an investor outside the USA and payoff Deerfield?

To me a potential factor that could have an impact in the long run is if trumps executive order allows insurance companies to start competing across state line. More competition is a win win for everybody especially the consumer. That could impact mnkd and insurance coverage down the road.

As far as cost just like Sirius xm when they started the more you sell the lower your cost but mnkd needs better insurance coverage so they can ramp up sales which definitely wouldn’t hurt the cost to produce. I think people who use the product prefer a afreeza but it’s the cost that’s my personal opinion on the refills. Not all people have a lot of money left over. I know I could not shell out 1,000 month or whatever it cost. I don’t have this health issue.

In my opinion this is a similar story to Sirius Xm except they never did a reverse split to get into compliance. Mnkd is a stock that can definitely be traded. Sirius xm was saved by liberty media. Mnkd could pull a Sirius but just like Sirius odds are against but you never know. Sirius in a matter of 72 hours went from almost having to bankrupt to negotiating a deal

[RisingSKEPTIC]

Questions have arisen on proboards about a form:

"Questions raised elsewhere by this form -- afrezza.aspnprograms.c...

Mine [digger]-- what is a Mannkind Cares Pharmacy and are titration packs available only at such a pharmacy?

Peppy -- what is an afrezza approved pharmacy?

Dreamboatcruise -- "The "Start Out Program" with a note that it isn't available to patients covered by state or federal programs... and it appears that the titration packs my only be available within this Start Out Program. Does anyone know what this "Start Out Program" is? and are titration packs really not available to patients covered by Medicare and other government programs?"

The questions arise from a section of the prior approval form that Mannkind Cares uses where it says:

"Request Start Out Program: oYes oNo

AFREZZA Titration Pack (NDC 47918-880-18) 1 pack, 2 refills
AFREZZA Titration Pack (NDC 47918-902 -18) 1 pack 2 refills

(For commercially insured patients only . Not available for Medicare, Medicaid, or other federal or state healthcare programs). Only filled through a MannKind Cares Pharmacy"

My OWN question is that it says the titration packs come with TWO refills. Now bear in mind that the 180 DOSES in EACH pack SHOULD last upwards to TWO MONTHS. So are they implying that it might take SIX months to "titrate" afrezza?

That certainly would agree with the data they presented to the FDA:

http://bit.ly/2wYVI4X

[whomeshanghai]

The best stretch of trx started oct 2015 over 5 weeks
627
583
560
603
581
But that revenue wasn't much different than now
Those same 5 weeks
371,000
304,000
297,000
322,000
280,000
----------------------...
7/14/2017----253.000
7/21----314.000
7/28----297.000
8/4-----290.000
8/11----322.000
8/18----312.000
8/25----337.000

[Looking For Diogenes]

Kastanes,
1) They don't have to file a SEC document at this time--but you can bet good money that Deerfield and the Mann Trust knows the situation. They still have a small amount of money in the till, so they ride it out for a few more weeks. As stated before---Deerfield and the Mann group converted worthless debt instruments for common stock. Their stock is the only thing that has an value, but as you can see if that is getting sliced and diced nearly everyday. Deerfield has made a tidy annual return on the interest they have collected, now they are shorting stock received for the face amount of their debt instruments. By shorting and let the stock go to zero they merely cover their short with the stock they got for the debt. Skinning the cat two ways at the expense of those holding the stock. YOU!
2) Can the Saudi government purchase Afrezza for their citizens! I would guess the rulers of this nation could do anything they want--it's not exactly a democracy they have. But, the recent event where many of the royal princes and wealthy operators were all arrested and held in a local hotel, this new kid on the block has shown that they must cut their nation's operating expenses--they no longer can dictate the international oil market. The elaborate and long approval process they have in place would require months or years to get a new drug approved. As stated in my article--Afrezza has the two most critical issues stacked against them. #1 is the cost of Afrezza. MNKD can never make their cost structure for Afrezza being the cheapest insulin product. Simply look at the gross revenues they have in the US--then look at their net revenue. Afrezza price of production and distribution is eating them alive. The Saudis have told you---price control, price controls--and MNKD can't afford to play their game, but Novo can. As the old adage is proven--10% profit on 100% of the pool of money is better than 100% of nothing.
Kastanes--I admit that I rub you wrong on occasions, but please, please don't let the trees get in your way of seeing the forest. Drug products fail everyday--ask Dendreon and consider they have hundreds of million of dollars in revenue, but their manufacturing cost eroded their chance of ever making a profit. Think about that, Kastanes!

[RisingSKEPTIC]

"...please don't let the trees..."???

Speaking of TREES, it appears that Receptor Life Sciences is still doing NOTHING but LOOKING at theirs:

https://receptorlife.com

Those must be very INTERESTING trees since RLS has been STARING at them for THREE YEARS now!

[bearrr]

Got to know when to Holdem and when to foldem son