MannKind Corp. (MNKD)

[COO2002COO]

To Refute Short Seller Comments by frumenti

Much of what I say here I have tweeted but I think the paragraphs below makes the tweets coherent and gives links to the actual documents so you do not have to rely only on my comments alone. All links in these comments must be copied and pasted into a web browser.


Script counts for Afrezza are below expectations for some of us. I am still very bullish on MNKD. I am a Type ll diabetic and I tried to get a prescription for Afrezza from my family doctor and he refused to prescribe it. He said the usual procedure for such a drug is to wait until endocrinologists had prescribed the drug and see what the results are and if it works then family practice doctors would prescribe it. Doctors that take that attitude will obviously will slow down sales. MNKD also has to overcome the bad publicity the previous “inhaled insulin” drug that failed received. Some comparisons have been made of Afrezza with a failed insulin inhaler Exubera. Here is an excellent article that explains why Exubera failed: www.nature.com/nbt/journal/v25/n12/full/nbt1207-1331.html Look at the size of the inhaler!!!!!! Would you take that out and use it in a restaurant or even carry that outside your home? Would it require a small suitcase? That alone would be cause for failure.


For those of you that think the Sanofi contract was a mistake I want to point out that Sanofi has 113,000 employees and MNDK has 268 employees. Which company has the organization to market Afrezza internationally and to market Afrezza quickly? Some people doubted Sanofi management's commitment to Afrezza. Sanofi included in management's annual letter to shareholders what could only be described as a full page ad for Afrezza. Not only was it a full page ad of Afrezza, it also included a picture of the inhaler. No management is going out on a limb like that for a product if they were not completely behind it. These annual letters also send a message to the entire organization what is expected of them in the coming year. The message is clear: get behind Afrezza and make it successful. Sanofi's own new drug for diabetes Tujeo is barely mentioned in the letter to shareholders.

Here is a link to the letter: http://en.sanofi.com/Images/38551_Letter_to_shareholders_N40_EN.pdf



Here is a quote from the announcement by the FDA of the approval of Afrezza;

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.” These were the FDA's words not MKND. I think the statement was very positive.

Here is a link to the news release: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm


Here is a link to the briefing document submitted to the FDA Advisory Committee

http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf


Quote from page 17 of the document:

“Barriers that limit effective glycemic control and impede compliance with starting/maintaining insulin therapy, such as clinical inertia, suboptimal insulin dosing and use, and fear of weight gain and hypoglycemia, contribute substantially to a patient’s glycemic burden. Earlier initiation of insulin remains an important unmet medical need. New insulin therapies that provide convenience, ease of use, and clinical benefit could be important additional therapeutic options for individualized DM management.” The FDA worded this document, not MNKD


The “shorters” should prove their points by providing links to facts. There was a recent article in SA that appeared to me to use a lot of data from a FDA document but came to a totally different conclusion than the writer of brief, and I think he ignored some positive information in the document I saw. I saw a 217 page document but could not find the 248 page FDA document he referenced.


Another article in SA tried to convince people there was a serious chance that MNKD might not be able to meet its debt obligation August 15 when a $100 million debt comes due. I think that article could only be described as ludicrous. I believe MNKD has enough money now to meet the obligation and will receive additional payments from Sanofi as provided for in the contract. Ask yourself: What is the agenda of people who make outrageous claims without documentation or projections which include all elements of future cash flow or no projection of cash flow at all ?
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The essence of the article was: Oh! There is a big debt coming due August 15, what ever will they do?

“Shorters” are claiming Afrezza has warnings about what might happen if you take the drug. I do not know of any new prescription drug that does not have warnings. It is part of the process for clinical trials. It appears to me they report every thing patients in the trial claim. Get any thousand and/or even hundred people together and there will be many comments and in my opinion many are not credible. If the comments raised serious health issues and the FDA thought them credible the FDA would not approve the drug. My doctor is a graduate of Harvard Medical School and 35 years of experience. He told my wife me not to read the warnings that come with prescriptions. Any drug new or old has risk. We weren't designed to eat or inject or inhale drugs of any kind.


What do we have documentary proof of? The FDA actually thinks Afrezza fills a gap in the treatment of diabetes and may improve patient compliance which has been a problem with diabetics. The FDA states that Afrezza may supply an “important unmet medical need”. Diabetes early stages has no pain and is easy to ignore. Sanofi management actually is very enthusiastic about Afrezza and told the company's shareholders that. Sanofi will bear the cost of getting the drug approved and marketed in the rest of the world. Sanofi is a giant company with 113,000 employees compared to MNKD with 268 employees. Sanofi has enormous resources in many countries and a contract with an incentive that Sanofi needs. The warnings on Afrezza are no more frightening than what is on most prescription drugs I have taken. Look at the labels on your prescriptions at home or listen to the warnings stated when you see a TV ad. The warnings read out to the viewer are often so scary I wonder why anyone who sees the ad would use drug..

Read more: http://mnkd.proboards.com/thread/2026/documents-refute-short-seller-comments#ixzz3VBSBu77D