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Interesting SO’s discussion. Your thoughts?

“Over the last month, many diabetes advocates were excited to see Congress get involved in the pricing of insulin via various hearings. That is great news for diabetics, but less than thrilling news for investors. The big players in insulin have responded with various cost-cutting measures. This dynamic makes life more difficult for Afrezza. With the price gap between Afrezza and other treatments getting bigger, it becomes more challenging for consumers to make the leap to a premium product. Many long-term MannKind investors reveled in seeing big pharma get slapped about on Capitol Hill, but that is in many ways a hollow victory in terms of your investment. It is clear that Afrezza cannot match the cost-cutting ability of the bigger and more established players. If Afrezza is forced into fighting a pricing battle, it will be tough sledding.

The flip side of that discussion might be whether or not Afrezza in the hands of others can open a window to a revenue driver for that entity. There could be a sound argument for Afrezza commanding premium prices that insulates a big player from getting slapped around. It is a tough argument to make, as the consumer market has spoken pretty loudly with low sales, but it is possible that some move could happen.“

SO had the final word bailing out MC (strange bed fellow). MC couldn’t have explained better than this. MC simply needs to reiterate the following at 1Q19 CC and ASM. Can we all get along? ✌️ With Elon Musk latest episode using Twitter, of course MC should stay social media silent. Don’t blame him.

It is renewing the current shelf. It is not dilution unless the company authorizes new shares, and that requires shareholder approval.
At this point it's a nothing burger.

MannKind has 280,000,000 authorized shares, and of that number, there are 187,774,030 outstanding. That leaves the company with 92,225,970 shares to work with. Of that number, the following have been spoken for:
..........
Shares authorized 280M
Shares accounted for 275,197,874
Shares available 4,802,126

As you can see, the shelf is virtually empty of shares. Any person assessing this situation realistically understands that having no shares on the shelf could create a number of issues. Some analysts believe that the 14 million shares tied to the $2.38 warrants would get exercised. That has not been my belief. With a bit over a week to go, I would think that most people think these shares getting exercised is not likely. If they are not exercised, the 14,000,000 shares associated with them will come back to the shelf. That would give the company 18.8 million shares to work with.

Given the cash situation at the company, it is my belief that MannKind will negotiate again with Deerfield to handle interest and principal with shares. With some quick numbers, I see that interest and principal due to Deerfield in the next few months total about $13.5 million. If we assume that the company is able to issue shares at $1.75 in lieu of cash, the matter would require 7.7 million shares. This would leave 11.1 million shares on the shelf, whilst preserving much needed cash.

The next shares that could become available are the warrants at $1.60 which expire in December. There are 26.67 million shares tied to those warrants. Here is the catch 22. If exercised, the shelf remains virtually empty of shares. If not exercised, the company gets that back, but it essentially means that the stock is trading at a level most shareholders do not want to see at that stage.

The Mann Group has 21.9 million shares tied to its debt. That equates to a conversion price of $4 per share. With the equity trading at under $2 per share, and the debt due in two years, it is not a foregone conclusion that the stock will be at a price point where conversion can be assumed. As early as Q3 of this year, the Street will begin to focus on that debt maturity. MannKind should, at some point in the not too distant future, begin to negotiate with the Mann Group on this debt. Those negotiations could extend that debt to a later date, as well as set a new conversion price to convert the debt to shares. Having only 11 million shares on the shelf to work with makes such negotiations difficult.

The bottom line is simple. Shares on the shelf is responsible business. In my opinion, it is not a question of if more shares are sought; it is a question of when. Yes, shares on the shelf allow for possible dilution, but investors in this equity simply need to be aware that the cash situation and debt markets virtually guarantee that shares will be used in an attempt to get this company over its hurdles.
seekingalpha.com/article/4251922-mannkind-annual-meeting-afrezza-scripts-cash

Public info:

“We have been working diligently with our partner in Brazil and regulatory authorities to secure our first approval outside the U.S. and hope to have an update for you on this surely as the holidays slowed down our review unfortunately. We need to finish our part one of our pediatric program to file what is known as a PIP in the EU before we can engage in a meaningful filing application for Europe.

We anticipate filing in Canada in the first half of 2019 and meeting with the European regulatory authorities to start a [indiscernible] over there as these are the two most common places where we get requests for Afrezza from our international inquiries.

We know it takes time to gain regulatory approval in these markets and we’ll make appropriate call to look for one go-to-partner ex-U.S. or continue to find key partners in each market like we did with Brazil and India.”

You ain’t see nothing yet.

“We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore.

We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.”

The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs for at least 6 months. Think of it as speeding up Time To A1C Target (TTT).

clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1

Brief Summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.

Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.

Afrezza Inhalant Product
Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm.

Primary Outcome Measures :
Percentage change from baseline HbA1c [ Time Frame: 3 months ]
Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.

Secondary Outcome Measures :
Percentage of patients having HbA1c under 7% [ Time Frame: 3 months ]
Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.

Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ]
Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.

United licensed MannKind's dry powder formulation of treprostinil, and has the option to collaborate on additional active pharmaceutical ingredients.

United licensed Arena's ralinepag for $950 million, and has the option to create an inhalable formulation for an additional $250 million using MannKind’s Technosphere.

MannKind's drug delivery platform will likely be applied to United’s currently approved medications, and compounds in development generating revenues for both companies.
www.google.com/amp/s/seekingalpha.com/amp/article/4223623-closer-inspection-collaboration-mannkind-united-therapeutics

On September 3, 2018, MannKind and United Therapeutics also entered into a research agreement (the “Research Agreement”) for the conduct of research by MannKind in connection with multiple potential products, including evaluating the feasibility of preparing a dry powder formulation of a compound within additional classes of active ingredients (outside the scope of the License Agreement) for the treatment of pulmonary hypertension. MannKind received an upfront payment of $10 million in consideration for its performance under the Research Agreement. In addition, United Therapeutics, at its option, may obtain a license to develop, manufacture and commercialize products based on specified compounds within the drug classes covered by the Research Agreement (the “Option”). Each specified compound advanced into development and commercialization under such a license would be subject to the payment to MannKind of additional milestone payments of up to $30 million and a low double-digit royalty on net sales of such products. The Research Agreement will terminate in the event that United Therapeutics does not exercise the Option within five years following the date of the Research Agreement, or in the event United Therapeutics exercises the Option and the parties enter into a separate license agreement as contemplated by the Option. United Therapeutics may terminate the Research Agreement without cause upon 30 days’ prior written notice to MannKind, and either party may terminate the Research Agreement in the event of liquidation, bankruptcy or insolvency of the other party.

secfilings.nasdaq.com/filingFrameset.asp?FilingID=12951922&RcvdDate=9/6/2018&CoName=MANNKIND%20CORP&FormType=8-K&View=html

Milestone A is $12.5 million
Milestone B is $12.5 million
Milestone C is $12.5 million
Milestone D is $12.5 million
Milestone E is $15 million
Milestone F is $15 million

Milestone Payments (A) through (D) shall be made no more than once (and each only upon the first achievement of the corresponding milestone), irrespective of how many Products achieve the corresponding milestone.

Milestone Payments (E) and (F) above may be paid more than once (i.e., if there are multiple Optioned Agents), but each shall be paid only once for the first Optioned Product for each Optioned Agent that reaches the corresponding milestone.

No unachieved Milestone Payments shall accrue and be due if notice has been given by United Therapeutics for termination of the Agreement

seekingalpha.com/article/4218970
A+B+C+D = $50M for Trep-T which may have multiple products.

E+F = $30M per first Optioned Product for each Optioned Agent which may spawn multiple products.

MC mentioned $37.5 M over 18 mos refered to A+B+C.