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Post by compound26 on Nov 12, 2015 18:05:19 GMT -5
Why? Evidence is showing that those using Afrezza need less basal. That's why. Unless Sanofi truly understands the game changing nature of Afrezza, and evidence seems to point that they are slow playing Afrezza, I don't see Sanofi sticking by Afrezza if sales don't pick up by 2Q of 2016. But that might be their plan to begin with. Only time will tell. Sanofi understands everything about Afrezza imo, and they're not stupid. Like I said, we won't have long to wait to put this to rest. You may be right, but for now, I highly doubt it. I agree that Sanofi must have been doing something in the background. The total expenses on the JV end is around $45 million per quarter. That's some serious money. If Sanofi is just putting minimum efforts I would not think Mannkind would agree to charge the JV $45 million per quarter. |
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Post by compound26 on Nov 12, 2015 17:00:25 GMT -5
A signed TS Partnership, you're kidding right ?? It depends on what the deal is and for what. Remember, the Afrezza deal was not well received by most and did not truly help the share price. Go look and see how the stock tanked right after the deal was announced on Aug 11, 2014. It was all downhill from there in general to where we now sit. Disappointing would not adequately explain where Mannkind is with Techsnosphere. There might be a lot of interest but if no one is willing to actually partner with Mannkind to bring something to market, then the company is most likely doomed unless Afrezza starts to get a foothold. And that brings yet another concern. Sanofi is having a problem with Toujeo gaining acceptance and if Matt Bendall is onto something with Tresiba being the optimal basal to go with Afrezza and not Toujeo, Sanofi will most like ditch Afrezza and use all its resources to try and resurrect Toujeo imo. That scenario again puts the screws to Mannkind. Maybe there is a white knight out there like Teva that will bail Mannkind out. Would Novo make a move? I dunno but Mannkind is radioactive right now. If Toujeo does not work well, it is because Tresiba is better product. And why would Sanofi ditch Afrezza if Afrezza works well with Tresiba. They are getting 65% profit from Afrezza. If they ditch Afrezza, they are getting none. If they ditch Afrezza, Novo can pick up Afrezza and make a combo of Tresiba+Afrezza. Wouldn't that put Sanofi in a much worse competitive position to defend its market share of Toujeo? |
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Post by compound26 on Nov 12, 2015 15:33:36 GMT -5
I guess Mannkind isplaying the same (hard to figure out) game then the shorts are playing? This is confusing to say the least. We are not informed as to anyones playbook so how do survive this type of game of chess? Is Mannkind deaperate or outsmarting the shorts? I certainly have no clue but I think we will soon find out. Fascinating stuff! This is the most fascinating stock I've ever held, Sherlock Holmes himself wouldn't be able to figure out the next move. Hopefully Al is our Holmes. I was thinking maybe we can get some of the best known authors to write a book on Mannkind's history so far. Perhaps we can have another blockbuster like "Barbarians at the Gate" or "The Great Short". Maybe a film will be made someday as well. Mannkind's history is so intriguing, with interesting characters like Martin Shkreli, Adam F and the insider trading at FDA. One candidate I am thinking of is Barry Werth, who wrote "The Antidote: Inside the World of New Pharma" and "The Billion-Dollar Molecule: The Quest for the Perfect Drug", both were about Vertex, a bio-tech company. |
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Post by compound26 on Nov 12, 2015 11:04:41 GMT -5
The TASE site indicates a closing price of NIS 10.48, which equals to $2.7248 (using an exchange rate of NIS to USD= 0.26; www.google.com/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=nis%20to%20usd). Still very good price (especially considering this is + 30.67%), which will yield to about $127 million for Mannkind, assuming Mannkind sells 50 million shares at that price (and taking out discount (3%) and placement fees/commissions (3.5%)). You will note that the price of NIS 10.48 has a "C" notation on it. You move your mouse over to the notation, it says Closing Price. It appears this is the final closing price. www.tase.co.il/Eng/General/Company/Pages/companyMainData.aspx?ShareID=01136639&CompanyID=001652&subDataType=0&This $127 million number is much better than most people expected yesterday (especially during the morning hours) as I think a lot of us at that point would expect Mannkind to be able raise less than $100 million. That additional $27 million will be able to support at least one (and probably a little bit over one) additional quarter of cash burn of Mannkind. |
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Post by compound26 on Nov 11, 2015 18:39:19 GMT -5
Some insightful comments from tudiabetes.org: www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/286People with diabetes tend to be skeptical... For good reason... They've been the target of countless "miracle cures" "diets" and snake oils of all kinds for many years. They're also people who learned a very rigid way of thinking about how insulin works and how it must be dosed. When your life, day in and day out depends on thinking within a rigid box, it becomes very hard to think outside it for many people. It didn't help that the fda added additional warnings, and more strict prescribing guidelines, against the recommendations of its expert committee, which raised some alarm that it might be dangerous, although there was no evidence of this... The fda had blew it with a lot of drugs in not too distant past so is very very cautious in covering their a$$ nowadays. Also bear in mind that most people with diabetes don't even know about it yet. It's a wonderful treatment, but it's not the only treatment. Other insulin are still effective, so the urgent "must have it" phenomenon that investors were counting on didn't materialize (this isn't viagra)--- it' will take a while to catch on. I will keep telling anyone who wants to listen how well it has worked for me. I think over time it will become more and more mainstream... I think the overall "internet sensationalism" of afrezza has also probably made some people more skeptical about it than they otherwise would be too--- wanting to not get involved when it seems like a lot of hype. My main concern at this point is that if it doesn't become a commercial success 1) it'd be a terrible shame, because it would not have the opportunity to tremendously improve the quality of life of millions of people, And 2) mostly, it won't be available to me. Those two reasons are why I'll keep preaching about how awesome it is... |
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Post by compound26 on Nov 11, 2015 18:27:18 GMT -5
And they conveniently not mentioning that Mannkind is raising additional funds while stating "After all, MannKind exited the third quarter with a mere $32.9 million in cash and cash equivalents. So, even with some additional funds available through its loan agreement with the Mann Group and sales of its common stock, MannKind would probably be hard pressed to execute such a monumental undertaking on its own. As such, investors may want to avoid trying to catch this falling knife for the time being.
"
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Post by compound26 on Nov 10, 2015 16:13:14 GMT -5
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Post by compound26 on Nov 10, 2015 13:23:16 GMT -5
Mike P's latest updates/comments (really appreciate Mike being a pioneer on Afrezza and sharing his experience with others along the way): www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/280Hi all - just wanted to post a quick follow up. I had my Spirometry FEV-1 test done again after being on Afrezza for a little over 6 months and it came out great. Doc said it actually improved a bit!! This is very refreshing news as I'm using Afrezza exclusively for all meal boluses and corrections. www.tudiabetes.org/forum/t/my-condition/48365/51Larry - welcome. 11.8 a1c is running close to 300 on average. No wonder you are always tired and feel terrible. It's great that you came here for help. Great people, great advice, very informative BUT you have to commit to putting the effort in to help yourself get better. No more, "well I should be doing this or I should be doing that", you have to take control and do it. No more excuses. -I was very reluctant years ago to wear a pump . . . it changed my life. -I was hesitant at first to wear a CGM . . . it's now my road map I cannot live without. - I dove head first into Afrezza and it has given me control and a1c's I never could have imagined while living a very normal life. It all may seem overwhelming but we will help you, this is a family in my eyes. We know what you are going through, the feeling of helplessness, nobody understands etc. . . . we've all been there and I still get there sometimes. None of us are perfect, but we are doing the best we can. You need to be able to look yourself in the mirror and ask yourself "Am I doing the best I can?" Right now, I think you know the answer to that question. Hopefully with your efforts, your doctors help, maybe a CDE and a couple books and this outstanding community that answer can change. Take care buddy, let's make it happen!!! |
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Post by compound26 on Nov 9, 2015 23:37:42 GMT -5
I think her performance actually improved quite a lot in this last interview. This interview is much more informative to the PWDs and public than the other several interviews we saw a few days earlier. Apparently she (and the Sanofi team) is learning and adjusting. That's a good thing.
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Post by compound26 on Nov 9, 2015 20:07:51 GMT -5
My fear is they cannot afford to pay the right people (people with proven resumes) their asking price to run this company. So we're either stuck with what we've got or we pick someone with a lot of potential that may not have a lot of experience and hope for the best. That's a little extreme. These guys did a great technical job, did great job with regulators, great jobs with patents, but then came Sanofi and all of this QUIET period about what we do not know. If this were a Silicon Valley Co. it would be worth multiples of ten billion. That's all I have to say. It is easy to say the management did not do well with hinder-sight. I think neither us (or most of us here), nor the management, nor even Sanofi expect that the uptick for the scripts were this slow. Exubera had better script numbers than Afrezza. How could anyone have thought than Afrezza will have a slower start than Exubera? The better choice would of course for the management to offer the shares to the market when the PPS was around $7. If only the scripts are double or triple the current count, management wouldn't be subject to such pressure right now. But on the other hand, if you think how much resources Pfizer probably put into the marketing of Exubera, you would not be surprised Afrezza's sales are so slow at this point. Given the unexpected slow uptick of scripts and the unprecedented shorting on Mannkind, I think the TASE offering overall is a pretty good solution to the cash situation. Kind of feeling that the TASE offering will be a turning point to Mannkind like when Ford had a second offering at $5 in 2009/2010 or when Solomon Brothers did the public offering for Geico to buttress its capital back in the 1970s. |
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Post by compound26 on Nov 9, 2015 19:18:30 GMT -5
Absolutely! And although dilutive to earnings this was probably the most shareholder friendly way to do it. Mannkind will be selling shares directly to the funds and essentially the funds will just hold them, not put them on the open market. Also they are not allowed to lend them short sellers. They will buy them in the next week or so if I heard correctly so I'm hoping we get a little move up in the next couple of days so Mannkind will get more money out of the deal. Three trading days to set the price for trading on the TASE. Three more days for Shorts to drive the PPS down. Any guesses on Thursday's closing price? I wonder if they will (can) push it down to 2 or so. If $2 on Thursday, then 50M shares @ $2 equals $100M. Of that MNKD gets $97M after 3% transaction fee. Not even a full year's worth of cash outflow per what Matt said today. He said 10 to 12 million a month, MAYBE 8 to 10 after recent cutbacks take affect. I think we will see the PPS decline each of the next three days. I hope and pray I am wrong. I think it's really two trading days here in the US. The offering price will be determined by the TASE closing price of 12 November. By the time we started trading here in the US on 12 November 2015, the TASE's trading day for 12 November will have closed. As for cash burn, the last quarter was around $18 million (6.3 R&D + 11.5 G&A = 17.8 million in total) per quarter (with manufacturing cost roughly balanced out by payment for product shipment and therefore not counted). Assuming manufacturing cost will continue to be roughly balanced out by payment for product shipment going forward, I do not see the cash burn rate going up in the coming quarters. As Matt has mentioned there was actually some restructuring charges for the last quarter. Below was my rough calculation of the numbers based on the last quarter's numbers. 107 cash balance on 30 June 2015 - 64.3 debt repayment - 6.3 R&D
- 11.5 G&A
- 8.1 manufacturing cost
+ 0.7 proceeds from warrant and option exercise + 7.2 payment for product shipment
+ 12.2 proceeds from ATM = 36.9 By my calculation, based on the numbers released in the press release, Mannkind should have around 36.9 million, not 32.9 million cash. That's a difference of about $4 million. Maybe that's for interest payment and other expenses. Or perhaps I missed something in my calculation. If so, guys please let me know. |
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Post by compound26 on Nov 9, 2015 16:48:48 GMT -5
By my calculation, based on the numbers released in the press release, Mannkind should have around 36.9 million, not 32.9 million cash. That's a difference of about $4 million. Maybe that's for interest payment and other expenses. Or perhaps I missed something in my calculation below. If so, guys please let me know. It appears Mannkind's cash burn per quarter is right now at around 18 million (6.3 R&D = 11.5 G&A), assuming manufacturing cost is roughly balanced out by payment for product shipment. The available cash balance (taking out the 25 million marked as not freely usable, it is about 8 million freely useable), ATM (37.5 million) and Mann Group facility (30 million) will be able to support another four quarters of cash burn without additional cash infusion. Within the next four quarters, we should expect to receive some type of milestone payments, Sanofi insulin supply, EU/Japan approval, and likely some payments in regard to another TS application in the pipeline. Receipt of one of such milestone payments will be able to support Mannkind's cash burn for another one or two quarters, which will in turn increase the likelihood for Mannkind to receive additional milestone payments before it needs to get additional cash infusion.
| 107 | cash balance on 30 June 2015 | | - | 64.3 | debt repayment | | - | 6.3 | R&D | | - | 11.5 | G&A | | - | 8.1 | manufacturing cost | | + | 0.7 | proceeds from warrant and option exercise | | + | 7.2 | payment for product shipment | | + | 12.2 | proceeds from ATM | | = | 36.9 |
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_______________________________________________________________________________ VALENCIA, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today reported financial results for the third quarter ended September 30, 2015. For the three and nine months ended September 30, 2015, product shipments of Afrezza, our novel rapid-acting inhaled insulin therapy, were $4.1 million and $17.1 million, respectively, which we recorded as deferred product sales from our collaboration with Sanofi. For the quarter ended September 30, 2015, our portion of the loss sharing arrangement with Sanofi related to Afrezza was $14.7 million, which we subsequently financed by way of an advance under the loan facility with an affiliate of Sanofi after September 30, 2015. The amount currently outstanding under the Sanofi loan facility is now $43.7 million, which includes $0.8 million in paid-in-kind interest. For the third quarter of 2015, total operating expenses decreased from $38.3 million to $26.0 million, a decline of 32.1%, compared to the same quarter in 2014, primarily due to Afrezza having moved out of clinical development into the commercial market. Additionally, non-cash stock compensation from the non-recurring achievement of performance and modification events in 2014 decreased in the third quarter of 2015 as compared to the third quarter of 2014. Research and development expenses decreased from $19.2 million to $6.3 million, a decrease of 67.2%, reflecting the transition from development to commercial activities. General and administrative expenses decreased from $19.1 million to $11.5 million, a reduction of 39.8%, mainly due to the decrease in non-cash stock compensation expense. Offsetting the total decrease of $20.5 million in R&D and G&A for the third quarter of 2015 were product manufacturing variance costs of $8.1 million. We did not recognize any product manufacturing costs in the third quarter of 2014 as we had not yet commenced commercialization of Afrezza. For the first nine months of 2015, operating expenses were $71.8 million, a decline of 52.0% compared to the same period in 2014. Total research and development expenses for the nine months ended September 30, 2015 were $23.5 million, a decline of 71.6% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement of performance and modification events in 2014 and in the first quarter of 2015. General and administrative expenses for the nine months ended September 30, 2015 were $32.6 million, a decrease of 51.2% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement and modification events in 2014 and in the first quarter of 2015. The net loss for the third quarter of 2015 was $31.9 million, or $0.08 per share, based on 405.2 million weighted average shares outstanding, compared with a net loss of $36.5 million, or $0.09 per share, based on 394.2 million weighted average shares outstanding for the third quarter of 2014. The number of common shares outstanding at September 30, 2015 was 418.3 million. Cash and cash equivalents were $32.9 million at September 30, 2015, compared to $107.2 million in the second quarter of 2015. During the third quarter of 2015, we paid $64.3 million upon maturity of the 2015 notes and received $0.7 million in proceeds from warrant and option exercises, $7.2 million in payments from Sanofi for product shipments, and $12.2 million in net proceeds from our at-the-market sales facility. Currently, $30.1 million remains available to borrow under our amended loan arrangement with The Mann Group and $37.5 million of common stock remains available for sale under our at-the-market sales facility. |
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Post by compound26 on Nov 9, 2015 14:52:24 GMT -5
See how good a control this Afrezza user has on his blood sugar. As a non-diabetic, I recall my last time fasting BG is 90 something. And PWDs with average BGs in the 80s and BGs not to rise above 120? At the same time, eat like a king?www.tudiabetes.org/forum/t/do-you-always-do-a-finger-stick-before-meals-or-do-you-use-your-cgm-instead/48493/26" I eat like a king. I do eat what most people would consider pretty extreme low-carb, but I eat foods that satisfy me--- I see no example in human evolution (or religion, if you prefer) of any reason why I need to eat breads or other processed grains on any kind on a regular basis. I use Lantus and novolog, and as of lately, primarily afrezza for bolus-- though I still find novolog to work better for fattier meals... Afrezza sure makes it easy thoughMy average BGs are probably in the 80s. I don't have any noteworthy hypoglycemia if I'm careful, which I am. I try not to let my BG rise above 120, though of course it does sometimes. I don't pump. I also find that exercising a lot seems to help me quite a bit..." |
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Post by compound26 on Nov 9, 2015 13:20:19 GMT -5
Guys, for your consideration, a comment that was just posted in Tudiabetes.org: www.tudiabetes.org/forum/t/type-2-new-to-cgm-getting-a-g5-what-to-expect/48355/5What to expect. Expect to have everything you know about how your body deals with food changed in a good way. I've been a T1 for 32 years and have had the G4 for a bit over 3 months. It will give you a very real and workable picture of your health. In my opinion (always ask your Dr. or Endo) you can not only see trends more accurately but most importantly you can see how just say a cold, stomach bug etc affects your blood sugar and how your diabetes medication brings down your sugars.. (I'm sure we all know how a sick day of any day can wreak havoc on our control) My only recommendation as far as the Dexcom goes is the sensor insertion. I know they (Dexcom) say it's only supposed to be used on the stomach but I've had poor success with it there. I'm also very skinny which makes real estate for insertion hard. I wear mine on the upper part of the arm (back) think where a Dr or parent would pinch the back part of your arm to do a shot (reverse side of bicep) I've had a sensor last 25-26 days there opposed to no more of 7 on the stomach. If your sensor is working fine when it says to remove it, don't you can just restart the sensor and act like it's a new one... it's works like a charm and saves on the pocket (and anxiety over inserting it though it doesn't hurt, just a pinch) Steer Clear of muscle, wherever you decide to place it make a muscle and make sure there is enough space between the skin and muscle to the wire does not graze the muscle. If this ever happens I recommend removing the damn thing and call Dexcom tell them you had a bad insertion and they will replace it, that easy. Just say you were using it in your stomach not an alternate placement as they will spend 20 minutes explaining why (cost too much to get FDA approval on other sites is what it boils down too) If you do decide to tough it out you more than likely will get a lot of  readings and gaps in readings. If you have any questions please ask. Sincerely, [XXX] [note; name edited out from the original post on Tudiabetes.org] T1 since 1984 Meters: Dexcom G4, Verio IQ Insulin: Afrezza 4U & 8U, Toujeo U300 Insulin
Hba1C: most recent 6.4, 3 months prior 7.7, 3 months prior 9.4
9.4 was prior to being on Afrezza
7.7 was the day before I got the Dexcom
6.4 was 3 months after the Dexcom
Presently my Dexcom says my 3 month average is at a
5.9, lowest I've ever had it. Proof is in the puding as they say! |
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Post by compound26 on Nov 9, 2015 12:21:48 GMT -5
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readings and gaps in readings. If you have any questions please ask.