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Post by greg on Feb 23, 2016 12:42:26 GMT -5
Brentie, Your quotation of Markey is dated by many months. In any case, I just listened to a replay of the webcast and feel very optimistic. I liked Matt's tone and confidence. He also comes across as extremely honest and credible, which is very important to me. I would encourage all longs to listen to the webcast, instead of relying on other's assessments. $59.5 million -$5 million owed to Deerfield this year=$54.5 million. Do you really think they can cut the spending down to the $4.54 million a month it would take to make it last a year? By the way, I don't think Matt said it would last a year. I would urge all longs not to base their investing decisions on Matt's tone and confidence. But it's your money. If your expectation is that MNKD will get no cash for the balance of the year, than your comment makes sense as does your advice. And if this is indeed your expectation, than I don't understand your presence on this page. My expectation, on the other hand, and the reason I remain long, is that some money is forthcoming and that the company remains a viable entity. I could be proven wrong but I believe there's reason for optimism. Anyway.....
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Post by dreamboatcruise on Feb 23, 2016 12:44:09 GMT -5
Thanks a lot Sla and Lab Rat! I'll listen to the call now. The only thing I see conflicting in the call breakdown is the cash point. I've only seen reports that it will take us into 2H 2016. I haven't seen any reports that we are good into 2017 yet. I'll listen now, thanks again! Obviously how long it will last is totally dependent on how much MNKD cuts their burn... which only MNKD management could know. So what you have seen is probably estimates of cash runway based on assumptions about spending at current level. It certainly seems that it would be hard to market Afrezza at all if they cut spending to levels that extend cash through end of 2016, but perhaps that is their strategy unless other cash comes in from deals in the meantime.
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Post by dreamboatcruise on Feb 23, 2016 12:45:44 GMT -5
lakers... hopefully that's settlement instead of indemnity.
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Post by BlueCat on Feb 23, 2016 12:47:47 GMT -5
Thanks a lot Sla and Lab Rat! I'll listen to the call now. The only thing I see conflicting in the call breakdown is the cash point. I've only seen reports that it will take us into 2H 2016. I haven't seen any reports that we are good into 2017 yet. I'll listen now, thanks again! Obviously how long it will last is totally dependent on how much MNKD cuts their burn... which only MNKD management could know. So what you have seen is probably estimates of cash runway based on assumptions about spending at current level. It certainly seems that it would be hard to market Afrezza at all if they cut spending to levels that extend cash through end of 2016, but perhaps that is their strategy unless other cash comes in from deals in the meantime. Matt's gotta walk a careful line between cost containment and strategic investment. General business wisdom is when chips are down, to invest in sales, reduce in other areas. As best I can tell, that's primarily what he's saying, without saying it too strongly and spooking Street.
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Post by mnholdem on Feb 23, 2016 12:52:49 GMT -5
I think it will be the deals with ex-U.S distributors and their upfront payments that we'll see first. I was very encouraged that, according to Pfeffer, two drug distributors called the day after Sanofi announced termination - and that these were companies that had been in talks before for the rights to distribute Afrezza outside the U.S.
It seems to me that as much as some people down-play the social media factor, with the lack of disclosure and Sanofi's not publishing anything about Afrezza, many other drug distributors may have been going to the only source of information available... the blogs and testimonials from early adopters.
Frankly, I don't think Sanofi is fooling anybody with their line, "we gave it our best effort". Other BPs may being seeing great potential, where Sanofi saw danger to their diabetes franchise. Guess what, messiers? You're are going to have BIG trouble when Afrezza gets in the hands of motivated pharmaceutical companies.
CASH will be coming sooner that we think, I suspect, but agreements cannot be signed before the L&CA with Sanofi is closed and the rights to Afrezza come home.
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Post by brentie on Feb 23, 2016 13:22:35 GMT -5
$59.5 million -$5 million owed to Deerfield this year=$54.5 million. Do you really think they can cut the spending down to the $4.54 million a month it would take to make it last a year? By the way, I don't think Matt said it would last a year. I would urge all longs not to base their investing decisions on Matt's tone and confidence. But it's your money. If your expectation is that MNKD will get no cash for the balance of the year, than your comment makes sense as does your advice. And if this is indeed your expectation, than I don't understand your presence on this page. My expectation, on the other hand, and the reason I remain long, is that some money is forthcoming and that the company remains a viable entity. I could be proven wrong but I believe there's reason for optimism. Anyway..... Greg, I never said that. I think they will get more money, we just don't know how yet or how much. My point in the original post was to point out that Kevin was mistaken when he said that $59 1/2 million would take MNKD to the end of the year.
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Post by dreamboatcruise on Feb 23, 2016 13:23:04 GMT -5
I think it will be the deals with ex-U.S distributors and their upfront payments that we'll see first. I was very encouraged that, according to Pfeffer, two drug distributors called the day after Sanofi announced termination - and that these were companies that had been in talks before for the rights to distribute Afrezza outside the U.S. It seems to me that as much as some people down-play the social media factor, with the lack of disclosure and Sanofi's not publishing anything about Afrezza, many other drug distributors may have been going to the only source of information available... the blogs and testimonials from early adopters. Frankly, I don't think Sanofi is fooling anybody with their line, "we gave it our best effort". Other BPs may being seeing great potential, where Sanofi saw danger to their diabetes franchise. Guess what, messiers? You're are going to have BIG trouble when Afrezza gets in the hands of motivated pharmaceutical companies. CASH will be coming sooner that we think, I suspect, but agreements cannot be signed before the L&CA with Sanofi is closed and the rights to Afrezza come home. Hopefully in addition to anecdotal tweets, there is a small but growing number of medical professionals that believe in Afrezza that MNKD can provide as references to potential partners.
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Post by Deleted on Feb 23, 2016 13:53:19 GMT -5
Remember, starting in April MannKind keeps all Afrezza revenues. While not much, it does extend the runway.
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Post by sccrbrg on Feb 23, 2016 14:00:57 GMT -5
They also have to start absorbing 100% of the cost - and I highly doubt they are operating at break even on 600 scripts per week.
If anything, I would imagine that shortens the runway. You're only looking at the better half of the equation.
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Post by agedhippie on Feb 23, 2016 14:12:15 GMT -5
Remember, starting in April MannKind keeps all Afrezza revenues. While not much, it does extend the runway. Before I go and dig through the numbers does anyone know if the extra revenue offsets the loss of the loan facility from a cashflow standpoint?
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Post by mnholdem on Feb 23, 2016 15:02:45 GMT -5
They also have to start absorbing 100% of the cost - and I highly doubt they are operating at break even on 600 scripts per week. If anything, I would imagine that shortens the runway. You're only looking at the better half of the equation. Very true, U.S. sales growth is needed big time to achieve break-even, but the possibility of sales outside the U.S. will add thousands of units for stocking foreign pharmacies initially, followed by however many scripts Afrezza may generate in those countries.
MannKind probably has quite a large inventory, whose COGS has already been put in the ledger and consumed cash. Post-April sales will return 100% of the revenue to MannKind, except for sales of units already purchased by Sanofi, which will bring in 35% of the revenue. That equates to much-needed cash to extend the runway.
I expect ex-U.S. partnerships will be formed, which means that there will be upfront payment(s) in exchange for the distributors cut of the profits. That cash will be used to continue pipeline development, unless a domestic sales partner for Afrezza cannot be signed, in which case the upfront payments will be used for marketing in the U.S.
I have no doubt whatsoever that MannKind 2.0 is being played out and Matt's priority is generating cash ASAP by getting Afrezza sales into other countries. What I'm really interested in is who those countries are, what the current drug prices are in those markets and how much margin can be realized there (ex-U.S. Afrezza is where the estimated $1Billion stockpile of pre-paid Pfizer insulin may also come into play).
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Post by lakers on Feb 23, 2016 15:23:08 GMT -5
12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind 13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential
14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency TrialsFormer Mylan CMO Ray said, "The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around. They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option. Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need. " Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz411J1bXsHMylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi's Auvi-Q® (epinephrine injection, USP) Recallwww.prnewswire.com/news-releases/mylan-confirms-availability-of-epipen-epinephrine-injection-auto-injector-for-us-patients-affected-by-sanofis-auvi-q-epinephrine-injection-usp-recall-300168925.htmlAccording to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences. [ Imagine Mnkd partners with Mylan for inhaled Epinephrine to beat Sanofi]
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Post by dreamboatcruise on Feb 23, 2016 15:50:02 GMT -5
Remember, starting in April MannKind keeps all Afrezza revenues. While not much, it does extend the runway. Before I go and dig through the numbers does anyone know if the extra revenue offsets the loss of the loan facility from a cashflow standpoint? No, if MNKD is doing any sales/marketing, Afrezza is not going to be cashflow positive. With the loan facility, all Afrezza activities were cash flow neutral for MNKD. Certainly, that cash coming in should be counted as to how long the runway is, but having SNY bail is not extending the runway as MNKD is certainly taking on more cash burn than the 65% of the revenue will cover.
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Post by suebeeee1 on Feb 23, 2016 16:36:38 GMT -5
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Post by agedhippie on Feb 23, 2016 16:55:54 GMT -5
Before I go and dig through the numbers does anyone know if the extra revenue offsets the loss of the loan facility from a cashflow standpoint? No, if MNKD is doing any sales/marketing, Afrezza is not going to be cashflow positive. With the loan facility, all Afrezza activities were cash flow neutral for MNKD. Certainly, that cash coming in should be counted as to how long the runway is, but having SNY bail is not extending the runway as MNKD is certainly taking on more cash burn than the 65% of the revenue will cover. Ok I did the math. Last quarter where we have numbers Mannkind drew down $14.7 million as it's share of the losses so the total losses would be about $42 million, giving an increase in the burn rate of $13 million per month minus monthly sales. Obviously any future operation is going to have to be a lot lighter touch!
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