could you expound on what you feel the adverse affects on long term lung function? Are you talking about changes in lung capacity
You need to nail this point over and over again and explain the significance of this on your website. This is the physiologic advantage of Afrezza which will lead to early adoption as tier 2 drug. All other products treat only half of the equation the pancreas. The other half of the equation is the liver. Affrezza appears to be sufficient in suppressing glucose production by the liver. Other RRA are not sufficient in this regard. They could do it but they would kill you in the process. Best of luck to you and your lightning in an inhaler.
I would expect that a company like MNKD would try to match production to demand as close as possible, while keeping approximately 1-2 months of inventory based upon the demand. They would then adjust production and warehoused inventory according to actual script demand. Could someone experienced in this field provide input. Afrezza has a shelf life I believe about 24 months from production. They must strive to provide SNY with product with 18 months expiration but 15 is acceptable per contract per their contract.
As long as the lines are for the production of Afrezza, SNY will reimburse the cost of those lines so I think its a mute point. Full capacity, if demand is good and product sold around the world then Danbury could not support alone. Danbury could barely support US sales for spectrum of diabetes. For ROW I would guess that 3-4 plants would be necessary. Certainly I would anticipate a facility in EU to coincide with EU approval since the EU is slightly larger than US. From what I read Russia and or China are protective of their markets and demand that raw materials and perhaps this could include the technosphere facilities are home grown. Approval of the sNDA for larger cartridge sizes could impact this prediction, not only from standpoint of 50% increase in output but also reduction in capital expansion.
He was outed as Peter Dodd from a talent agency in California. On facebook and linkedin. By his response or denial when outed I would say it was spot on.
"The average annual price of $3,100 will be almost dead on, so change it at your own peril"
I would also caution you that this is a retail number and not what SNY will derive. DWAC is approx. 20% less.
Please check your math.
165,000 + 50% (2x175000)= 340,000
Thanks rad. Im starting to see these numbers when I sleep. Here is the bottom line. For ten years we have been hearing that this will be a blockbuster or mega blockbuster drug out of the gate. We have been told that SNY also independently confirmed managements sales projections. Why would anyone expect that we would go to market not having the capacity to reach a billion dollars in sales the first year?
I provide some stats you could then use for your next napkin.
Commercial production of Afrezza started on Nov 1 and was revealed at Nov 3 CC.
Obviously pre commercial product was being produced in October. This inventory can be sold as well as the commercial production, so a considerable amount of product is manufactured during the certification process.
New machinery is at least 10% more efficient than the first line. This I confirmed directly with Matt. Just how much more efficient he would not say so only comfortable with 10%.
The initial line was capable of servicing 167,000 patients with product. So newer lines should support about 184,000 patients with product, with smaller cartridge sizes.
Lines are restricted by number of cartridges produced not patients served, so when larger cartridges are approved production capacity could be increased as much as 50%.
Based upon current cartridge type Danbury could support fully expanded 12 lines which would service 2million patients. 2mil/12lines=166,666 patients (167k). Again this is based upon the initial slower line and current smaller cartridges. Furthermore, management has stated the 2 mil patients supported could provide sales worth 4 billion. I give you this number only because it supports the DWAC pricing of Afrezza at $2000. If a single line is up and running based on smaller cartridge size they could support 167,000. As new lines are certified this year Danbury will have the capacity to service 535,000 patients in 2015. This number could drastically rise if larger cartridge sizes are approved.1 line running 1 full year and 2 lines running perhaps9 months provides capacity for about 445,000 patients in fiscal 2015. This should be worth just shy of 1 billion in sales to the JV, or somewhere in the realm of 250m to MNKD. Of course this assumes demand is equal to production and no other lines are installed. Add the current 200 mil in milestone payments and your good to go. Bartender, can I get another napkin!
I will agree if Fuerstein publishes an article that is supportive of Afrezza. A total mea culpa! Either they just want to be on the winning side in the end or something spooked Cramer.
Second sight and other business ventures that Al is a part of are just that, ventures.
Technosphere and Afrezza are Al's babies. He has nurtured, raised and supported his babies to adulthood. A parent usually only releases the responsibility of their child when they can support themselves or when they are married to a good supportive fostering spouse. Did Al step away from his baby prematurely or does he have complete confidence in the partner(s) he has found for his babies. Hmm.
In that regard a CT order and terms of the partnership does not prohibit a competitive bid for Afrezza rights or a partnership/sale of Technosphere rights.
The agreement provides a right of first negotiation if a competitive bid comes in, and oddly provides for continued rights to Afrezza if a change in control occurs by a redacted (singular?) entity.
Like many on this board, I sense there is more to come. Yes, Sanofi has rights to Afrezza and may someday own them outright. The bulk of MNKD, Technosphere, may have garnished the interest of another player. The silence is deafening, but something else is afoot. Sanofi knows who the entitiy is and has agreed to their involvement. Quite frankly at this point in time, MNKD is the only entity that explains the collaboration of MDT and SNY. Neither Sanofi or MDT has offered any physical result of their diabetes collaboration agreement to date. Both companies share a history or relationship with Al Mann and MNKD. I always felt that agreement between SNY and MNKD was agreed to hastily to preserve what they had at the time. Odd for a relationship which was in the making for years. The only thing I can reconcile this with is that it was done without participation of the third party MDT due to the regulatory problems they experienced with their inversion.
"(b) In the case MannKind, BV or TICV undergoes a Change of Control involving […***…], Sanofi may by written notice delivered to
MannKind within thirty (30) days after the first public announcement of such Change in Control, elect to retain its rights to Product hereunder and
discontinue MannKind’s participation in the Development, Manufacture, and Commercialization of Product hereunder, in which case Section 13.4(b) shall
There is only one reason for the redaction. The redaction consists of a singular named entity. If it was a vague entity or vague description of possible reason for change in control there is not a reason to redact. If a singular entity is named it only means that at the time of partnership negotiations a dialogue of sorts existed between MNKD and said entity.
It does not mean that buyout talks or sales of intellectual property are imminent, only that another party expressed some kind of interest in what MNKD has to offer, and MNKD believed to protect their interest in that it be spelled out. Sanofi has agreed therefore that only a singular entity noted is allowed to gain control of everything but Afrezza, quite different than the right of first negotiation (refusal).
Did you ever sign a contract with a realtor, knowing that you had first contact with a potential buyer, and wanted that buyer excluded from the contract?
It does help explain management's slow adoption of TS applications. They have known the top applications for some time and could have given guidance several quarters ago. They decided to be slow and deliberate as if waiting for something to occur first.
As a very long long as well, I have witnessed,
Al Mann is a senile old fart
Exubera first to market first to success
Afrezza is no better than Exubera
Afrezza will fail like Exubera
All big pharmas drop inhaled insulin because there is no market and no benefit
If BP cant do it MNKD cant possible do it
Trials will not succeed
MNKD manipulated trial results
MNKD withheld trial data from FDA
Needles don't bother diabetics
Status quo is good
It too expensive
They will never partner
It will never pass Adcom
SNY not interested in success of Afrezza
Too many side effects
The list goes on and on, and Afrezza and MNKD have proven each of these as false assumptions. Im not saying we should put the label of success on just now but since the first Rx were written yesterday it certainly time to stop, celebrate a certain level of success and forge forward to help spread the word of its availability.
This is first and foremost a rollout to educated the physicians first, that's why you have seen no commercial advertising. Clearly, SNY wants to educate the physicians directly about the advantages of the product. You may be surprised that many physicians are reluctant to prescribe medications when asked for by name by the patients. In the case of narcotics, patients may be perceived as educated shoppers. In drugs like Afrezza, the physicians risks looking as if he is unaware of current advances and ego may inhibit the prescription. SNY understands the patients and the physicians well. Introduce and educate the product to physicians first and when the patients request to try the product the whole process will be easier.
Never under estimate an individual’s desire to live a better life. The market, hedge funds, competitive companies, even supporting companies have differing motivating factors that generally focus upon the bottom line as single most important factor in the success of a product. In the end, the ultimate success or failure of a product comes down to the end user and in t his case the type1 or type2 diabetic.
The type 1 diabetic has been around since the dawn of history. Prior to the discovery of insulin in 1922 the patient had zero treatment options and the diagnosis was simply a death sentence. Great strides in diabetic treatment have occurred since that time. Although the diagnosis of type1 diabetes is no longer a death sentence, it is universally understood that the life span of a diabetic is restricted and the generally quality of life is reduced. The reduction of the quality life is reduced not only from the significant morbidity of end organ destruction from the disease, the quality of life is diminished from the strict adherence of multiple injections, finger testing, office visits it take to be “in control” of the disease. The constant threat of death always hangs over the patient even with treatment as a result of severe hypoglycemia.
My point being, the success of Afrezza comes down to the patient. If Afrezza even provides a small benefit to the lifestyle of the diabetic, if it provides benefit in any way to reduce diabetic morbidity, if it in any way reduces the potential for mortality then diabetics will request the treatment if they are aware. For some, Afrezza will not provide any benefit, but for most it will improve the quality of their life and quality of their treatment. The paradigm shift in the treatment, monitoring of diabetes is about to begin. The algorithms of care of both type1 and type2 diabetics are soon to be re-written. I see a well deserved Nobel prize in someone’s future. GLTA especially those burdened with the disease! Hope has arrived.