MannKind: Weekly Data Updates
Oct. 12, 2015 12:16 PM ET | About: MannKind Corporation (MNKD), Includes: GSK, SNY
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Summary
•The latest weekly data for new Afrezza prescriptions and renewals.
•My weekly interpretations of the data, plus commentary on the weekly stock trend.
•The latest news relating to the diabetes market that could impact MannKind.
Three-Month Chart for MannKind:
Chart Provided by Yahoo.
The above chart reflects the last three months of trading in MannKind's (NASDAQ:MNKD) stock. Considering that MannKind's inhaled formulation for its insulin product is now being marketed by Sanofi (NYSE:SNY), if revenues are important for a stock price, this report where I'm sharing the third weekly new prescriptions and other relevant data should help my readers evaluate the underlying critical information relating to MannKind.
I opted to start this weekly endeavor by applying the starting point for the weekly data ending 2nd quarter, 2015 (6/26/15). With the 3rd quarter now ended, this will give my readers the data that should indicate what they can expect when both Sanofi and MannKind report their respective financials for this quarter.
The prescription data that I cite is provided by IMS and Symphony, as they represent the best sourcing of information that relates to tracking drug industry information. I obtain my initial information on the Nrx, Trx and Projected Revenue numbers from the MNKD.Proboard. One can find several boards that track the data on a weekly basis. It should be noted that these boards require one to join the site before having access to their information. Plus, I verify the NRx and TRx data from an associate that has normal access to this information. I assume the data being provided by my sources is accurate. Readers can form their own assumptions as for the validity of my sources and their data input.
Comments on Weekly Data for Afrezza:
With the drug now going into the ninth month on the market, the trend in prescriptions being written for Afrezza needs to start showing a major improvement - and soon. Over the last fifteen (15) weeks, we have seen weekly NRx going up only seven (7) times while going down (8) weeks. The latest week shows a drop of 6.50% in NRx. The more important data point of TRx showing another downturn in getting refills doesn't indicate the willingness for physicians or patients opting for continuing the use of Afrezza.
Comments on Weekly Stock Activity:
If there is validity in stock prices going hand-in-hand with revenues generated by a company, the continuing struggle for MannKind's stock doesn't bode well for investors. During the recent week, while the overall market was showing strength, MannKind's stock came within $0.02 of touching its 52 week low. However, at the close on Friday, the stock was down another 7% from the previous week.
At an investor conference this past week, the CFO alluded to the outstanding debt issue that has been around since mid-August. Instead of giving investors any firm data, he once again deferred to some future date for sharing any information on what has become a critical issue for evaluating the future for MannKind. Current debt obligations, along with the addition of more and more debt with the resolution being tied with generating sustainable profits, the stock price and the lack of success to date in the marketing of Afrezza doesn't indicate a bright future. The CFO has now gone for more than a year without providing an explanation for how the Sanofi partnership works and is now demurring from giving any explanation for a debt obligation due two months ago - that should be a surefire way to instill doubt for anyone invested in MannKind's stock.
Latest Industry News:
For many years now, Mannkind has touted the potential for expanding into new products with its Technosphere technology. Earlier this year, it made another effort to revive this business expansion plan, where it recycled back the same claims and potential products made many times before. To confirm this recycling effort and ponder why it continues to defer from providing investors any firm information, as opposed to its secrecy claim for keeping its competitors and investors in the dark, I went back several years and looked at its annual reports. In these SEC filed reports, one would hope there is some degree of accuracy in what information is being imparted to its investors. In just one annual report, it made the following comments about its Technosphere technology. Twice in this one annual report it stated the technology had been well received. If one goes back even further in its history, they can find the company commenting on how well the product was being received and it was actively exploring opportunities to out-license its technology.
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"AFREZZA utilizes our proprietary Technosphere© formulation technology; however, this technology is not limited to insulin delivery. We believe it represents a versatile drug delivery platform that may allow pulmonary administration of certain drugs that currently require administration by injection. Beyond convenience, we believe the key advantage of drugs inhaled as Technosphere© formulations is that they can be absorbed very rapidly into the arterial circulation, essentially mimicking intra-arterial administration. Currently, we are actively working with several parties to assess the feasibility of formulating different active ingredients on Technosphere© particles. Additionally, our inhaler technology has been well received and has the potential to be utilized for the administration of dry powder formulations for various other applications.
Capitalize on our proprietary Technosphere© and inhaler technology for the delivery of active pharmaceutical ingredients. We are actively exploring opportunities to out-license our proprietary Technosphere© formulation technology. We believe that Technosphere© formulations of active pharmaceutical ingredients have the potential to demonstrate clinical advantages over existing therapeutic options in a variety of therapeutic areas. Additionally, our inhaler technology has been well received and has the potential to be utilized for the administration of dry powder formulations for various other applications."
Now after years and years of laudatory comments such as 'well received', 'potential to be utilized', 'various other applications' - if one surveys the inhaler medication market and related drug development efforts, one could point out to MannKind that this market has numerous trains that have left the station with the company standing on the station platform still looking for its ticket to its mythical town of WellreceivedVille. Considering the old adage about promises, MannKind apparently has forgotten that they are meant to be kept. - "Promises are meant to be kept, for they are like precious pearls in an ocean, their value is high and quality genuine and true, and once they are made they can never be broken."
Inhaled medications have been utilized for decades. Today, most of the major pharmaceutical companies have development projects in this method of medication dosing. So, if all this development is taking place throughout the industry, it would beg one to ask why hasn't MannKind been able to secure a partnership with one of these major companies that actually has the monies to fund the clinical development of such an inhaled product? Instead, the only visibility for MannKind has been with operations that have no history of drug development or entities that have no funds to conduct any clinical trials. For proof of this lack of viable interest in using MannKind's Technosphere product and its 'potential', one can find one example of a clinical trial utilizing Technosphere for a new drug application, other than Afrezza.
One example of current clinical development for a new inhaled product can be seen in the efforts being put forth by Pulmatrix (NASDAQ:PULM) and its partnership deal with another drug company. What is unique about this company's efforts is that it has even received funding from the National Institute of Health, the governmental agency that funds promising products. Considering this funding source and all the years MannKind has touted the potential, it could be asked why MannKind hasn't sought or received funding from the NIH if the company has something worthy of continued development. Apparently, the NIH saw merit with Pulmatrix's inhaled technology!
*** (Note that I'm not recommending anyone to invest in Pulmatrix's stock. It is years away from gaining any drug approvals. I cite it only as an example of what is happening with inhaled drugs.)
But if one wants to see what major drug companies are doing in the inhaled technology area, I would suggest looking at what GlaxoSmithKline (NYSE:GSK) is doing. Instead of MannKind's secretive efforts with nondescript and underfunded partnerships where no money is being paid to MannKind for its technology, the recent expansion announced by Glaxo and Liquidia speaks volumes to what happens when someone has a inhaled technology deemed worthy for cash, development funding and royalties on products flowing from their partnership.
MannKind makes only unverifiable promises and operates under a cloak of secrecy with the pretense that it doesn't want competitors knowing what it is doing with its 'blockbuster' potential inhaled technology. But this is what GSK publicly submits to its investors:
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"We are pleased to continue our collaboration with Liquidia. The exercise of our option supports our commitment to explore advances in science and technology by investing in new platform technologies. These could have the potential to improve current approaches and offer new alternatives to patients," said John Baldoni, Senior Vice President, Platform Technology & Science at GSK.
I have no proof for why there has been no validation of the Technosphere technology where it's being utilized beyond mere MannKind's promises of great interest from others. However, I might speculate as to why there has been no one beating a path to MannKind's door offering to utilize its technology. We know that Sanofi has priced Afrezza at about a 70% premium to regular insulin. Such pricing should allow one to assume that the conversion process for turning a drug into an inhalable powder formulation is a very costly process when using the Technosphere platform. There is no magic to the inhaler, as such products are a commodity item in the drug industry and have been for years. So the exorbitant pricing for Afrezza must come from the insulin conversion methodology.
If one does any research on the capabilities of the platform being offered by Liquidia, they can see the scalability and wide application its technology provides and with what appears to be cost-effective creation of the end-product. Spend some time reviewing the basis of the Liquidia platform and compare what it states about its capability and the cost-saving merits of its approach, and then note that for all the years of MannKind's promises, it has never shown anything comparable as for what the Technosphere product can offer other potential partnerships. At the end of the day, and with the many years that MannKind has promoted the potential for others using its technology, nothing has been provided for public consideration that shows anyone having any interest in MannKind's promises of the product being 'well received'. Is it true secrecy from competitors learning about Technosphere's applications that MannKind is promoting, or is it really a case of its technology being the red-headed stepchild at the family reunion?
Good luck with your investing decision! It's my sincere hope that Afrezza will continue to be available for those patients who need options in treating their medical condition.
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