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In connection with this (cash situation of Mannkind), I recall at one point Mannkind put its headquarter in California up for sale?  Does anyone know whether it was sold? I vaguely recall it was up for sale for a price of $10/20 M, can't remember correctly. Buy, hey, $10/20 M helps at this point.

Also, someone posted that the upcoming $25M milestone seems to be related to certification of Sanofi's insulin as a supply to Mannkind, does anyone have any update on that?

DBC, I think it depends on how much Mannkind gets out of the total sales. Does Mannkind get $330MM out of $1.32B sales, or does it get $115M out of 1.32B sales. I hope it's $330MM, but you seem to think it is $115M.  Hope we can at least get the $115M profit soon. 

My understanding is that Sanofi (and probably Mannkind) has just adjusted their strategy after they got the data of sales from the last several months.  Originally, I think both Sanofi and Mannkind were always mentioning both the insulin intensification patients (T1s) and insulin initiation patients (T2s) as their targeted markets, with them sometimes even emphasizing the second group as their core target market. 

However, as we have seen in the last several months, apparently, T1s are more enthusiastic about Afrezza than T2s, even though the overall population of T1s are much smaller. I recall this board has discussed this phenomenon. Probably T1s are generally more concerned about managing their BG and are more knowledgeable about the subject. I also think it is much easier to dial in Afrezza if you have a CGM. Most T2s do not wear a CGM, while many T1s do. In that sense, T1s appear to be an easier market for Afrezza (compared with T2s).  Perhaps it is also easier for T1s to get insurance prior authorization cleared.

If indeed this is an adjustment in their marketing strategy. I think this is the right move. Once Sanofi and Mannkind take care of the T1s market, it will be much easier for them to move to the T2s market.

Off topic: could Mannkind's market cap be 10 times higher if we have someone like Elon Musk to do all the PRs. 

Agree. Sanofi should be very concerned now that Tresiba is approved by FDA. Per Matt's videos uploaded in the last couple weeks, it appears Tresiba has an edge over Lantus (and most likely Toujeo) and Tresiba + Afrezza is a better combination vs Lantus + Afrezza. 

Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count?  I don't know how this works.  If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday?

blindhog1, you probably can shed some light on this since you are being included in a study.

For what it is worth, here is the google translation of the article:

Enter measures on 15 November. The current market capitalization of the company stands at $ 1.5 billion, allowing a share to enter the TA-75 Index, TA-Biomed and other measures. A slight increase in market value may make the stock even Tel Aviv 25 Index.

The effect of this move has been felt on Sunday with a record turnover TA75 stocks and a decline of 0.66% in the index, against the market trend was positive. In an attempt to mitigate the impact TASE CEO announced that the first stage there will be no diminution of existing shares indices following the entry of Mankind . However, Mankind's entrance to the stock exchange in Israel is expected to make a mess in leading indices, and stimulate significant demand per share amounts editors from 300 to 500 million ₪ only the part of the ETF. Institutional investors are also attached to the indices will have to decide on the share of the company is foreign to them.

Let's start from the end:

Company Mankind landed in Tel Aviv when it is in trouble financially, and the only product that has - inhaler insulin - already marketed by its partner Sanofi in February this year is growing slowly. The market of insulin indeed huge, but highly competitive and did not seem to have ventilator insulin of Mankind clinical benefit on the faces competing with insulin injections beyond fear that some patients of syringe stabbings.

We believe that a company value of $ 1.5 billion taking into account an optimistic scenario much about sales potential of the inhaler, and does not reflect the commercial risk exists only product of the company, the strategic risk eliminate the likelihood of agreement with Sanofi and financial risk inherent in the volume of low cash and Peripherals high debt, while significant cash flows yet to appear on the horizon.

If the inhaler will eventually become a huge success Mankind will earn big, but in the meantime what greater is the risk.

Who, Mankind?

Company Mankind (MannKind), that is unknown to investors in Israel, specializes in inhalers introduction of drugs through the respiratory system, with a single product inhaler insulin (AFREZZA) approved for the treatment of patients with diabetes and was launched earlier this year by Sanofi. Sales at this stage is still very low and does not manifest reflected in revenue.

An initial indication of what people think the stock of Mankind Wall Straight can be learned through the volume of short positions stands at 45% of the floating shares. Also according to data compiled by Bloomberg only three out of nine analysts covering the stock recommend the stock Kenya. Bottom line, the receipt of approval from the FDA about a year and a quarter of Mankind's stock has lost about two-thirds of its value.

The main question to be asked - why Mankind must fly so far and land precisely B"flntt Tel Aviv "? What Israel is searching for her missing Wall straight?

To try to answer the questions need to understand what the company does Mankind, especially acknowledge the company's flagship product AFREZZA, the Company's collaboration with pharmaceutical giant Sanofi and of course the financial situation.

The company's flagship product, an insulin inhaler immediate treatment (Rapid Acting), received in June 2014 FDA approval for marketing as a treatment for patients with type 1 diabetes and type 2 insulin dose in need of closely meals, to prevent the sharp rise in blood sugar levels. The face is a revolutionary product obviate the use of insulin injectors immediate treatment, and has tremendous sales potential for a huge and growing market, as of 2014 was $ 24 billion in sales per year worldwide. Although insulin market is very competitive, but all products are direct injection or pump. Only in the category of immediate-release insulin products, there have been three major products: Novolog (Novo), Humalog (Lilly) and Apidra (Sanofi).

Mankind's product was launched in February 2015 by Sanofi. At this time the launch progresses slowly, with the second quarter of 2015 sales of the inhaler were only $ 2.2 million. During the third quarter, Sanofi launched a campaign to aggressive marketing and advertising, the fruits of which we will see, if at all, only after the publication of quarterly results.

Importantly inhaler of Mankind is not the first attempt to launch the Ainsoliin inhaler. About 10 years ago, Pfizer competitor launched a similar product named Exubera, but less than two years after launch, with disappointing sales rate of 12 million a year, Pfizer pulled the product from the market on the grounds' that the product failed and was not accepted as a treatment for diabetes patients or among doctors ". Analyzing the reasons for the failure were several points including: the cumbersome size of the facility, the inability to accurately dose inhaled insulin incoming and fear of the side effects, especially the rise in the incidence of lung cancer. Other companies also stopped the development of inhaled insulin, such as Eli Lilly, despite her inhaler was smaller and easier to use.

The weak sales pace of Mankind's new inhaler, AFREZZA, can attest to that Sanofi may have encountered problems similar to the problems encountered Pfizer. Despite improved inhaler

Mankind much smaller and user-friendly, some problems still exist. The product has few side effects not unique for the provision of insulin through the lungs, coughing, among other things, a decrease in lung function, and concern increased incidence of lung cancer. Respiratory system naturally would make small molecules of oxygen into the bloodstream, and is not built or designed to absorb large proteins such as insulin. FDA approval of the product emphasized that the product is not intended for use in patients who have lung diseases like asthma and COPD. It is also required to perform pulmonary function test (Spirometer), a test that could present a particular barrier against passage of insulin injection insulin inhaler.

We believe that the level of effectiveness of the treatment, insulin AFREZZA product no significant clinical advantage over injectable products. However, there are side effects associated with the provision of specific insulin through the respiratory system. Although the company is trying to paint their product clinical advantages over the competition, in the FDA refused to accept their claims and confirm the allegations Diagram of the drug. In our opinion, ease of use of the product and the natural fear of needles stabbing there will not be enough for a big chunk immediate-release insulin.

Sanofi could under the agreement to announce the agreement with Mankind from January 2016. There is concern that if the product launch phase will not rise, Sanofi does exercise its option to exit the agreement, which of course would be a severe blow to Mankind. Reinforcing concerns can also get the deal structure with Sanofi signed after completion of the clinical development and approval from the FDA. The agreement includes the distribution of profits (and losses), Mankind's share is only 35%, plus milestones payments totaling only 725 million dollars, mainly related to sales volume. We believe that the structure of the agreement and its terms indicate that Sanofi concerns about the commercial potential of the product and Sanofi's desire to participate Mankind company with high commercial risk that product. If the inhaler will eventually become a huge success Mankind will earn big, but in the meantime what greater is the risk.

The company's financial situation is problematic, as the dwindling cash reserves can not serve in the debt and expenditures of the company. How difficult the situation can be seen only after the publication of the reports of the third quarter, which is expected early November. At the end of the second quarter were $ 107 million, of which the Company used $ 50 million as reimbursement of debt holders in addition to the current cash burn rate. We believe that cash reserves expected to be approximately $ 30 million alone, the amount of which can hold a maximum two quarters the Company and the Company will have to raise capital in the immediate term.

Steven Tepper, pharma and biotech analyst at the IBI Investment House

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