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AMRX cannot have agreed to too high of a commission if the deal was for levothyroxine. This is a very old drug that has been around since at least the 1960's, was off patent by some time in the 1970's, and forty-years later there is plenty of generic competition. All of that translates to thin margins (like on most generics) so there is not a lot of extra profit to share with a commissioned sales partner.

That aside, if MNKD wants to drive sales of Afrezza then they need to get "face time" with endocrinologists. Even if MNKD never makes a penny in commission, so long as AMRX is subsidizing the cost of the sales force then it is a positive because it results in MNKD being able to afford more office visits which translates into more NRx. The other upside is that getting face time in any clinical environment has gotten very difficult and salespersons with more than one drug in their bag are generally more successful in getting that valuable face time.

As for why their market cap is what it is, consider the segment they are in. Generic drug companies have very limited ability to increase prices and the infrastructure costs are considerable. Until and unless some of their branded drugs take off, they are going to get generic drug company valuations. They also have a huge debt load, even for a generics company, which weighs down the equity value.

Two years after start of trial is a minimum depending on what FDA asks for.  There is that pesky trial that the company agreed to run on lung function that has never been completed, and while many think this is something MNKD will never have to address, FDA may think differently (they have a long memory).  If FDA does give a pass on this requirement, and doesn't think of any new requirements, then two years is entirely plausible.

I do not think it is feasible to find a partner that will market the drug to the pediatric and Type II segment unless than partner also has the Type I segment.  There are several examples of companies that tried to co-market the exact same drug using two different marketing channels for different indications and all of these arrangements wound up a mess.  Suffice it to say that keeping track of which dose goes to a Type I patient versus a dose to Type II is nearly impossible, and if the co-promoters do not coordinate pricing very carefully pharmacists and the payors rapidly figure out which channel is the cheapest and they buy all their product from the low cost option.  That makes one partner very happy and one partner very unhappy which is why these deals tend to fall apart quickly.

No partner is going to help pay for a trial unless they have significant say over the trial design and label claims.  That is pretty normal in the industry.  The difficulty will be finding a partner willing to take on Afrezza given the history with Sanofi.  Lilly and Novo are not going to be volunteering to cannibalize their injectables market, and finding a third party that wants to jump into the pricing scrum around insulin products is going to be a real challenge.  I don't think a 1Q21 start date is realistic given that the partner has yet to sign up.  Once a partner is announced, it will be 3-6 months before the first patient is trialed because the trial has to be designed, submitted to FDA, investigators have to be recruited, the plan has to be submitted to the institutional review boards, and so on.  None of that happens overnight, even with the most capable partner.

I have said for a long time that MNKD needs to have its own drugs in the pipeline so this is a very positive step.  TS delivery is an interesting technology but the economic benefits of any new drug accrue mainly to the holder of the patent on the drug, not the delivery system.  There have been many companies founded to commercialize drug delivery technologies that never made it because despite all the research the spoils went to the owner of the molecule, not the delivery system.  That is why TS delivery for generic drugs is never going to be a big profit driver and why all those compound remain unpartnered.

There are more companies out there with novel drugs that have potential for treating respiratory diseases, and most of the past market leaders in this segment (notably Pfizer) have abandoned respiratory drugs altogether.  This may be the change of focus that this company has needed for a long time.

Yes, the minimums have been lowered significantly and future growth has been reduced as well.  The details can be found in the 8K filed on EDGAR.  The previous minimums looked unachievable from the start, requiring hockey stick growth intervals, while the new minimums look reasonably achievable.  There has been a lot of water under the bridge since the original credit facility was set up, including a certain virus we all know about, and these changes simply reflect the reality of the situation.  Lenders never want to put a company in default if they can avoid it because it is usually not in their best interest.

Stability testing is standardized for a reason, and all regulatory agencies follow similar procedures.  If the company had data that Afrezza was stable without refrigeration for three months, then they could have gotten that on the label BUT if they could only show three months then they would also have gotten a three month expiration date.  Three month expiration is not as bad as, say radiopharmaceuticals, but in the real world that is a very short shelf life; many customers will not accept product without at least six months remaining before expiration barring exceptional circumstances.

When a company submits the CTD to the agency either the data supports room temperature storage or it does not.  The tests are extremely simple to do; the drug and packaging are placed inside a test facility with specific temperatures, lighting, humidity, etc. and samples are drawn out at set intervals and the product is tested to see if the molecule or protein has changed.  If there is no change then the drug is considered stable under the specified conditions (there are companies that do nothing but stability testing for the industry).  Approval of the label copy is not a matter of what BP wants, what competitors want, or what the company itself wants.  If the required data from properly administered tests exists then that is what goes on the label.  It is not a political decision, it is a chemistry test.

This looks like a typical directed development project.  When you see a company getting a series of grants, especially if previous grants have come from DARPA or the DoD, then somebody has built a very effective political presence in Washington.  Congress has the ability to create new grant programs and, simultaneously, direct the agency that is managing the grant program to award a large chunk to a particular company.  You don't get $590 million in federal money to build out production of an unapproved product unless there is a friendly senator or representative working behind the scenes.  The fact that the jobs are going to NC, which is rapidly becoming a battleground state, doesn't hurt either.

Mike needs more than a phone number; he needs an effective government affairs executive that knows how things really get done.