Hard as we try we are not making this stuff up.
Diabetic Investor is seriously considering sending a thank you note to the many companies in the diabetes market who make our job so easy. Today set of news is yet another example that as hard as we may try we just can’t make this stuff up.
The first piece of news comes from our friends at MannKind (NASDAQ:MNKD) who continue to believe that one day Afrezza will magically morph into a multi-billion dollar product. Never mind that the drug has yet to make through the FDA or that it may never make through the FDA. Or that the company has more problems than Tom Brady has passing yards, MannKind is once again hitting investor up for additional funds. According to a company issued press release;
“MannKind Corporation (Nasdaq: MNKD) today announced that it proposes to offer, subject to market conditions, senior secured discount notes due 2017 (the “Notes”) expected to yield gross proceeds of approximately $370.0 million.
If the offering is consummated, the net proceeds from the offering of the notes would be used for development and operating capital, including completion of the Phase 3 clinical trials of MannKind’s lead product candidate, AFREZZA, preparing for commercialization of AFREZZA, continuing the build-out of MannKind’s Danbury, Connecticut manufacturing facility, ongoing research and development efforts, and general corporate purposes.”
Now Diabetic Investor hates to cast dispersions on MannKind but one has to wonder who would be nutty enough to buy this notes. As we noted on several occasions even if the company is successful at getting Afrezza to market, a huge IF, the product will face several obstacles and require even more millions to market the product. To Diabetic Investor this announcement is further evidence that the company is unlikely to survive over the long term and could soon be toast, burnt toast that is.
Under the category of how best to lose customers insulin pump maker Animas, a unit of Johnson and Johnson (NYSE:JNJ), seems to be having some issues of their own. For some time Diabetic Investor has been aware that Animas customers have been having a hard getting pump supplies from the company and worse having problems getting through to the company. Making matters worse Animas customer service personnel, when a customer actually gets through and speaks to one, have been offering a wide range of explanations for this supply disruption. The situation has become so bad that the company has actually sent a letter out to their customers.
The letter states:
“Animas is currently aware of some delays that patients are experiencing in reaching our call center for supply order status updates. We are currently putting additional resources and processes in place to help ensure that we follow up on every call as soon as possible.
In response to recent supplemental payor requirements, as it relates to prescriptions and Certificate of Medical Necessity (CMN) forms, it is highly likely that Animas may need to contact your physician for an updated prescription and/or CMN form. This does not in any way affect your ability to continue receiving supplies from Animas. Additionally, once any supplemental paperwork has been verified and received, you will no longer experience any potential delays. Our primary goal is to ensure that you have the proper amount of supplies needed, while also ensuring we have the appropriate documentation on file. Animas is doing everything possible to meet your demand for supplies quickly and accurately, with as little affect as possible on you directly.
In the meantime, if you have a critically low amount of supplies on hand, please feel free to call us at (877) 937-7867 immediately. Otherwise, please continue your commitment to Animas as we work through getting the appropriate paperwork required by your insurance company.”
Although the many insulin pump companies getting set to enter the market may have a difficult time going up against market leader Medtronic (NYSE:MDT), situations such as this will make it much easier to steal share from Animas and Insulet (NASDAQ:PODD), as Diabetic Investor has noted previously Insulet has its own share of issues. What all pump companies seem to forget is that while there are some differences between systems all pumps do basically the same thing. They also seem to forget that pump patients are some of the most vocal patients in the diabetes community and word spreads quickly when things go wrong. Most of all they seem to forget the cardinal rule when it comes to the insulin pump market, customer service is everything.
Finally comes the following statement from the FDA’s Diagnostic and Devices Letter, and please try not to laugh, “The FDA should write clearer definitions and add flexibility to its regulatory approach to mobile device medical applications (apps), experts at an FDA workshop said.” Really, ya think. Now Diabetic Investor does not know who these “experts” are but whoever they are you’ve got to hand it to them for overstating the obvious.
Saying that the FDA needs greater clarity and flexibility in this area is about as groundbreaking as stating that the Bears offensive line needs to do a better job protecting Jay Cutler to have any chance at all at beating the Packers this Sunday. No kidding.
Like we said before we are not making this stuff up no matter how wacky it sounds. As a good friend of Diabetic Investor has stated many times; “No matter how hard we try real life provides us with situations that no fiction writer could make up no matter how hard they work.”