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Pricing will be up to UTHR and that doesn't usually get announced until the product is approved or very late in the approval process.  Normally a company will charge a premium for a new formulation, but there are Tyvaso competitors that will be eating into UTHR's market share so a "new and improved" formulation at about the same price is a good way to retain market share.  So long as it does not result in a huge price hike, it may not cause much of a stink with managed care companies.

The unknown is what happens with Liquida's product.  Liquida and UTHR are doing the usual dance in court as UTHR tries to slow its competitor, but they are destined to lose that game (although a six month delay in market entry might justify the legal expenses).  When Liquida hits the market with their inhaled version, that will set the bar for how much UTHR can charge for TreT.  Sometimes companies are happy to price high and enjoy some of the spoils from owning part of a highly-priced therapeutic segment, while others will try to compete on price and grab market share by undercutting established players.  It is impossible to say what Liquida is thinking at this stage.

You are comparing apples and oranges.  Some drugs do a better job of keeping patients out of the hospital or otherwise improve healthcare outcomes, and those are readily prescribed.  If an insurance company is asked to pay a $1,000 premium per year for a cardiovascular drug that substantially reduces the chance of a three-day inpatient stay, they will gladly pay it.  If the new drug has a $1,000,000 per year premium, they will not pay for it because the certainty of the drug cost is not outweighed by the cost savings it might provide.  While most people don't like to think about the cost-benefit analysis that takes place in insurance providers every day, I assure you that the industry has it down to a fine science and that is precisely how they look at drug prices.

Afrezza claims certain benefits over other insulins.  MNKD tends to do small and underpowered studies, which is why they fail to demonstrate superiority in a statistical sense, but even if we assume that the benefits are real the economics are not quantified.  It we assume that patients consume at least 1 box per month, and that a box of Afrezza is at least $1,000 more expensive than RAI analogs, that tells us that Afrezza adds $12,000 a year to the cost of care.  Most people claim that Afrezza users need more units of Afrezza than injectable, so $12,000 is a conservative estimate.  Now, how many hypo events are avoided and how many of those events require an emergency room visit and what do all those emergency room visits cost?  If 1,000 patients are on Afrezza at a $12,000 premium, do the avoided emergency room visits cost more or less than $12 million?  What is the cost impact of "superior post prandial control" for a T1 patient?  Is better time-in-range worth $100 a year, $1,000 a year, $10,000 a year, or some other amount?

None of those numbers are easy to come up with, but they can be calculated.  That is what Mannkind has failed to do.  As I said above, there are clinical attributes that potentially justify the higher cost, but simply demonstrating that the attributes exist is not the same thing as economically justifying the price of the product.  In a country where healthcare costs absorb 18% of GDP, it is necessary to quantify the economic savings if you want to sell a product at a higher price. 

Sorry, my crystal ball is in the shop for its annual service so I am unable to answer that question.  However, consider that the cash flow from operations through six months was $-14.9 million and that the number included $16.4 million in collaboration payments from UTHR.  In other words, but for the UTHR payments cash flow from operations for six months would have been $-31.3 million.  If that loss rate continues going forward, then the cash balance of $63.3 million should suffice until year end which leaves the balance at around $30 million at year end of which $15 million is required to satisfy a MidCap covenant.  In other words the company will be down to around one quarter of cash flow by December net of the MidCap covenant. 

However, it is never as simple as this and a few events could change that answer.  If UTHR makes its fourth and final milestone payment, the cash can last a bit longer.  Are there other UTHR-type deals in the works?  Those could extend the runway significantly.  If the government agrees to convert the PPP loan to a permanently-forgiven subsidy that will likewise help, but if the government decides that MNKD had adequate access to the capital markets and didn't really qualify for the PPP then the loan will come due sooner.  Commercial sales of Afrezza are unlikely to be a material contributor of cash in the next few quarters. 

Given the overall economic environment management might simply decide that they need more of a cash cushion due to the reduced ability to forecast the future, and that would argue for more balance sheet cash.  The number one rule in biotech is to raise money when you can and not when you need it.  If the financial markets remain cooperative, I cannot fault any development stage company for raising more money.  

I think that particular ship has already sailed.  The company pretty much admitted that they would not be hitting the targets in the previous 10Q:

"An assessment was performed as of March 31, 2020 to determine if the Company was on target to achieve certain milestone conditions that are required in order for the Company to access further borrowings under the MidCap Credit Facility. The Company determined that such milestone conditions related to Afrezza trailing net revenue are unlikely to be achieved. As a result of this assessment, a $1.5 million asset impairment was recognized for the three months ended March 31, 2020."

Any good executive recruiter will have a list of ten fully-vetted candidates that can replace Mike within 45-60 days.  There is plenty of talent out there.

The problem is lack of capital and, as agedhippie noted, a lack of comprehensive trials that proves the value of the drug.  You cannot charge a premium price for a drug unless you have the data and you can't generate the data without capital.  Unfortunately, at this point the company is not producing enough revenue to self-fund the necessary trials and the balance sheet was too impaired to have any realistic hope of raising the necessary capital, and that was before COVID took its toll on the financial markets.  Absent a handful of tech stocks, nobody is raising serious money at the moment.

It is not that hard to replace Mike, but any successor will run up against the exact same hurdles that Mike has to deal with.  If anybody thinks the US financial markets can simply be charmed out of a few hundred million dollar by a new face then you need to think again.  I don't think Mike is particularly stupid, lazy, or inept at raising money; he is just trying to bluff his way through a poker tournament with nothing more than a pair of twos in his hand.  Mike inherited a business model that is inherently broken and has been unable to fix it, and any replacement executive will not be in any better position.  The choice is to abandon the business model or watch the company run in circles indefinitely.

The available evidence suggest that both insulin and Vitamin D exert their effects by their effects on the toll-like receptors which are usually the starting point for an severe inflammatory reaction.  Vitamin D, in particular, up-regulates production of cathelicidins and defensins which are two classes of molecules that attack pathogens as part of the immune response.  Neither insulin nor Vitamin D are a cure for viral pathogens, but they do help to maintain immune competency for those who would otherwise be immune compromised. 

The growing body of evidence is that all the people who have been exposed to COVID but who either were asymptomatic or recovered spontaneously without suffering significant effects did so through activation of T-cell responses from a healthy immune system.  That is why many of these recovering patients do not test positive for antibodies, which are produced by B-cells rather than T-cells, and it also explains why COVID has a more severe set of implications for older patients because the innate ability to mount strong T-cell responses declines with age. T and B cells are both part of the immune system, but they work in different ways and B cell responses normally need T-helper cells to accomplish their effect while T-cell immunity can often do the job by itself.  Either way, a strong immune system is your best defense against any pathogen.

So no, Afrezza is not a magic bullet that will kill off COVID, but a healthy immune system might.  If you are a diabetic and your disease is not well-controlled then now is a really good time to get it under control.  If you live in a northern climate or do not get outdoors very much, a little extra Vitamin D in your diet (or via supplements) is not a bad idea either.

Insurance companies are rational; they want to charge enough in premium to settle future claims and make some profit.  When you cannot forecast your future claims, that spells risk and no business likes to take on excess risk.  That is the main reason why companies shifted from "occurrence" policies to "claims made" policies because if your underwriters are seriously in error the company is only exposed to that bad judgment for a single year.

When rates started to get way out of control in Florida (around 2003) some neurosurgeons were paying $400K for a $1 million policy.  Many of the patients a neurosurgeon treats are trauma and crime victims that roll through the emergency room door, and not surprisingly many of those have no medical insurance.  Many surgical specialists simply refused to treat any emergency patients because the personal financial risk wasn't worth it, at which point the Florida legislature was compelled to limit "pain and suffering" damages to bring premiums back to earth (they are now around $200K for general surgeons).  The eye-popping malpractice awards are not for true compensatory damages, they usually result from non-compensatory awards.

My wife did not quit practicing due to the overhead, she quit because I had a job opportunity in Asia that was very compelling, and at that point she was tired of juggling a husband with a heavy international travel schedule, the demands of her practice, and raising three children.  I don't know any dentists priced out of the market due to malpractice insurance, the claims are never that big in dentistry, but I know a few physicians that decided it simply wasn't worth it and retired prematurely.  We are all worse off when experienced practitioners simply walk away because the administrative hassles overwhelm the pleasure of practicing their chosen profession.