|
|
Post by saxcmann on Oct 6, 2016 19:48:27 GMT -5
Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? I recall the studies showed a 30%/50% (can't recall exactly as I can not get access to the full report any more) plus reduction in hypo rate. www.easdvirtualmeeting.org/resources/reduced-hypoglycaemia-is-observed-with-inhaled-insulin-versus-subcutaneous-insulin-aspart-in-patients-with-type-1-diabetes-mellitus--2Interestingly, in the this video of Al Mann (the discussion regarding the hypo events starts at around 11 minutes of the video), it appears in the main study (I assume it is the study for Type ones, study 171), Al Mann mentioned that in that study, there is one person who accounted for more than half of all the hypo events in the study. Al Mann said in the video that Mannkind would investigate why this person had so many hypo events. Wonder if they have found anything. Anyway, if you take out that person (an outlier), the hypo events would have dropped another 50%. That would mean Afrezza probably reduced the hypo rate for all the other users (i.e., excluding this one outlier) by 75% plus. Imagine Mannkind can claim that in the label!
And this result seems to be consistent with the observations shared by the real world Afrezza users (that Afrezza is less likely to cause a hypo in the first place and even if it causes a hypo, because its fast-in and fast-out nature, the hypo event would be less severe). Wondering if Mannkind has any plan to use the less hypo data for label change or anything else? If they did and get approved it would be much better than "ultra" on label, my endo friend says. Unlikely because not enough data to support tho. |
|
|
|
Post by saxcmann on Oct 4, 2016 12:54:18 GMT -5
One innovative vehicle for raising capital that is generating attention in the market lately is royalty-based financing. Instead of purchasing an equity interest in a company, the investor lends the company a set amount of funds, just like a regular loan. Repayment, however, can be structured with more flexibility than a loan. For example, the company could make repayments that are calculated solely as a percentage of the company’s revenue stream over a period of time.
To illustrate how royalty-based financing works, suppose a company needs a $50-million investment. It is possible that the company could find an investor willing to lend the money on a 10-year repayment plan with an interest-only repayment in the first year, principal and interest repaid in equal monthly installments over the next nine years and, perhaps, payments of three percent of the company’s monthly revenues during that same nine-year repayment period. The investor would reap a return on principal, together with interest and the royalty amount, and the company will have achieved fairly low-cost financing without giving up any equity in the company. This same repayment scenario would play out even if the loan did not have an interest component to it, but if it just involved repayment of the loan based on a percentage of the company’s revenues. In this context, the same $50-million investment may require a longer repayment period, and the revenue stream to the investor would be more susceptible to swings in the company’s revenues. On the other hand, without the interest component, the repayment of the $50-million investment carries less risk of default since all payments to the investor are from the company’s revenues. Under either structure, it appears to be a win-win for all. And, if like many of these royalty-based financing investors, the investor takes a warrant for a small equity position, the investor could see some additional reward from a future sale of the company without taking any additional risk.
Of course, this type of financing would depend on the investor's assessment of whether a drug will succeed if funded.
and does Mann foundation have the funds to do such financing? With so much invested thus far, it would make logical sense to take it to the final step? If they do have funds , whats the incentive for others to invest , when they themselves are not stepping in? Good question! Why not take final step especially if Al said so? Just not sure how much money they have either? What are they waiting for? Maybe waiting on something?...scripts increase?, new deal/partner?, SNY settlement?? |
|
|
|
Post by saxcmann on Oct 2, 2016 11:33:18 GMT -5
Well aren't we just sunshine and happiness this morning. I think most investors on this board are painfully aware that script sales are very low. There is tremendous risk with the current cash position of MannKind and its current cash burn rate. But you totally ignore the progress being made with word getting out through multiple venues, including social media, conferences and even JDRF walks like this weekend. MannKind is present at no less then 12 walks this weekend all over the country. Until the insurance coverage is better and Endos understand Afrezza better, TV commercials would be wasting that precious money you mention above. Your post reminds me so much of my many years following the Yahoo Message Board. The negativity there was very intentional. Is yours? Has any progress been made with spirometry? Or any with insurance reimbursement? If anything, insurance seems to be getting worse. Afrezza isn't even showing up on the medicare plan search page anymore. The one I found still had it as tier 4 but used the old NDC. Getting word out and walking until the cows come home home won't do much good if endos refuse to prescribe and if patients find the price tag is too high. Pure FUD. In fact simply the opposite is true. Insurance is improving and spirometry is a non issue. My endo friend says all insurance is going thru. His staff sends patient information to mnkdcares and they take care of everything. Really easy on his part. In my opinion we need more patient awareness thru advertising and medical education conferences, etc. Still as Sports suggest, PWD still don't know about afrezza...yet! |
|
|
|
Post by saxcmann on Sept 29, 2016 19:43:50 GMT -5
This positive guy picked "no". i hope so.. but the new me is looking for upside surprise  Oh please gambler! I expected no from you...We all remember you from yahoo days! 😊 |
|
|
|
Cash
Sept 27, 2016 9:03:20 GMT -5
via mobile
Post by saxcmann on Sept 27, 2016 9:03:20 GMT -5
Mannkind is going to need some and I understand it takes a bit of time to raise. So the question for the board, what is the most realistic scenario? Common Equity - at current SP, more dilution would mean SP below what, $0.44 or a bit lower and is this even a possibility for a company that has received a delisting notice? Debt - are there any assets to be used as collateral? Publicly Traded Debt - not sure what ramifications are. What Knight - business partner who kicks in a minimum of $50 mm Sanofi settlement - does not seem likely Company X (If profitable with positive Cash Flow) does a reverse merger into Mannkind - would this allow the losses to be used and is it even legal? Insulin Put - modest amount of money that would not provide much runway to continue operations. If anyone has other ideas as to how we raise $$, please share your thoughts. I know Matt P said there is enough to get us to Q1 '17. To me this means maybe mid-Jan but it would not surprise me if there is only enough to get us through early December. Either way, its not like any of this can be done in a week or two so realistic to think Mannkind is working diligently to address this. Last question, when do you think is the latest possible date we will hear something about additional cash being raised? -Mann Foundation Still several months to fund. Everyone watching scripts growth...October will be crucial. |
|
|
|
Post by saxcmann on Sept 23, 2016 19:11:20 GMT -5
I could be wrong, but I thought it was that sample packs were free, but not titration packs. Sample packs free and titration packs free through mnkd cares. |
|
|
|
Post by saxcmann on Sept 22, 2016 20:55:38 GMT -5
I tell you what. You are the second person to comment on this thread today. If the board wants, I'll stop the thread. I know volume on this stock pretty well now. With that caveat, when the stock went from .69 to 2.24 last time, I caught the volume pretty well. A couple of people messaging me made it out pretty well. I did mention when price failed. Pep Don't stop. Mnkdfann is no fan of mnkd. |
|
|
|
Post by saxcmann on Sept 22, 2016 14:47:57 GMT -5
Agree... Time is of the essence to infuse more cash into the business. I have to wonder how Castagna was convinced to take the CCO position given the state of affairs at the time of recruitment. Cash was an issue then as it is now. I can't believe he took the position without assurances from management that cash would be forthcoming to adequately fund the business, either that or that he would be rewarded monetarily for the risk he is taking should sufficient cash prove impossible to raise. Dilution is certainly an option, but I would much prefer that the cash come from elsewhere - perhaps a setttlement with Sanofi, a milestone payment from RLS or a sizeable gift from Mann's estate for example. In my wildest dreams I fantasize that Castagna is a plant from Allergan sent to Mannkind to assess the internal state of affairs prior to a takeover bid- haha. I don't know, but I'm getting concerned about the cash crunch. Perhaps Friday's scipts will so large as to ease my concerns but the number would have to be a blowout and I don't see that in the cards as yet. Oh well, nothing to do but wait and see what happens. Let's hope Matt pulls a rabbit out of his hat. I totally agree with the observation about Mike Castagna. He has demonstrated he is competent and determined. He clearly knew what he was doing, and I don't think his stock purchase was a head fake. The company has a plan, and I agree that they also have contingency plans for funding that we will learn soon enough. There have been a few bumps in this 2.0 launch but scripts are trending in the right direction. There has been lots of speculation here about a looming "pop" in the numbers, but that remains to be seen. Consider the number of representatives and what they realistically are able to accomplish. Paradigm change (disruptive technology) takes a while to develop. Opinion leader Endos prescribing for the first time need to see results from their patients and get comfortable with a new tool. The real dramatic growth, IMO, will come from patient demand; and we've heard time and time again that PWD's don't yet know about Afrezza. Let's face it, whether by intent or incompetence, SNY did a poor job of marketing, and they had deeper pockets and a larger sales force. Their strategy was different and perhaps they underestimated the time needed to gain traction. Or, perhaps they never intended to be in it for the long term. Overall, my opinion is that their performance was lackluster by design once Brandicourt took the reins. They phoned it in and ran out the clock, but they still managed to get the weekly new Rx count to well over 300 before they re-deployed their efforts. I hope not, with lots of long shares averaged down to $3.0 in my deeply underwater MNKD account, but it may be that the ramp to break even is just longer than the current resources will support. I'm praying that skillful DTC advertising will be the saving "Hail Mary". Let's hope so. GLTAL Chris Great post Chris! I agree and same boat. Not sure this is my buddy from yahoo? but seeing more and more familiar posters from over there. |
|
|
|
Post by saxcmann on Sept 22, 2016 12:01:57 GMT -5
Matt, honest question here. Why wouldn't Mann Foundation increase credit line $100 million rather than approve 20-1 reverse split? This would give about a year for mnkd to get scripts to increase and see if afrezza can succeed in market place. Lets say Mannkind Foundation already invested $900 million at $1 and reverse split is approved by BOD then wouldn't Mann Foundation net worth drop to $45 million? Why would they do that?? Part of Al's last wishes was give mnkd every chance to succeed so in my opinion they would rather increase credit line than R/S. reverse split doesnt cause networth go down. Market cap remains same. reverse split followed by dilution , may get the share price down in which case the value goes down and also you get to own lesser piece of the pie cos sharing with the others. the last dilution of 100 mil shares already reduced the %age owned by Mann foundation Good point. Not sure what I was thinking. I guess I was thinking share price would go down again after R/S because I assumed more dilution coming. Percentage owned by Mann Foundation would be reduced again with dilution. Not sure they want this but maybe no choice. We sure need a new deal or scripts to start increasing soon. My projections have scripts jumping up in 2-3 weeks. Hope I'm right... |
|
|
|
Dilution?
Sept 22, 2016 11:52:28 GMT -5
via mobile
Post by saxcmann on Sept 22, 2016 11:52:28 GMT -5
$100,000,000 line of credit wouldn't guarantee the price would rise over $1 per share and may even dilute it further. Also, with the trustees involved now, they don't make emotional decisions like Al may have done with his namesake company. Right now the company is bleeding heavily and a trustee would potentially open himself up for a lawsuit if they piss any money away on a company with a balance sheet like MNKD. Never said 100 million would get pps over $1 but scripts would if more time for runway. I don't think increasing credit line by trustees is an emotional decision either. Trustee lawsuit for adding credit line if Al wanted?...lol Okay newbie! |
|
|
|
Post by saxcmann on Sept 22, 2016 10:19:50 GMT -5
Would there be enough buyers for that number of shares without some empirical data that 2nd launch will be more successful than first? I think it is pure guessing game as to when and at what price dilution will occur. I just don't have that sort of feeling that enough people would have a grasp on probabilities to have anything meaningful "baked" into current price. We've held steady at levels before only to crash through them. There are always buyers but it won't be at 70 cents. I have seen a lot of biotechs go through this kind of situation, looming delisting notice with scarce cash, and there are never any "good" buyers. The true healthcare investment funds (Orbimed, Atlas, etc.) will not touch MNKD because it is not the kind of stock they invest in. The good funds want biotechs with novel drugs, preferably first in class, that have a strong marketing partner and a clear playing field. Insulins have become a commodity and even big players like Sanofi are about to feel the pain of the PBM and managed care companies trimming their formularies. Yes, I know you will all say that Afrezza is the best rapid acting insulin and that it should not be compared to other insulins, but it is the market perception that counts and not the reality of the drug. Venture capital firms spend the time to get into details on their investments on private companies, but funds that trade public companies do not so the details aren't relevant to the investment decision.
So what you are left with is the other funds (several adjectives come to mind but this is a family friendly forum so I will refrain from using them). These guys invest to get the discounted shares and sell them quickly, usually within 20-30 days. They don't care if Mannkind sells insulin, mobile telephones, solar panels, or t-shirts; a discount is a discount and in any case they are not hanging around for more than a few weeks so why care about the product. Their primary metrics for whether they will make an investment is the size of the discount, the average daily volume of shares traded (they need somebody to buy the shares they plan to sell), and the volatility since they want an extra pop on the warrants they will demand. The level of analysis is rarely more sophisticated than that.
As for the dilution being built-in to the present price, there is some of that to be sure. When the market knows that a company will have to raise more funding the price inevitably starts to drop and when the funding actually hits there is another drop (because the new buyers want their discount from whatever the market price is as the time). The worst mistake companies make is to wait; the longer Matt goes without pulling the trigger the more the PPS will decline due to the looming dilution which will only make the share price that much lower for the new deal. Had Mannkind stepped up and done a funding when the share price was $1.00, it might have dropped the PPS to 70 cents, but by waiting the overhang and uncertainty let the price move to 70 cents anyway and now the next funding will almost certainly drop it below 50 cents. The price also takes a hit on reverse splits, and one of those is in the near future as well. None of that is a secret to the market.
Time to rip off the Band-Aid. Go ahead and man up, tell the shareholders the bad news that a reverse split is coming (personally I would do something like 1 for 20), conduct the shareholder vote to authorize it, and get back in NASDAQ compliance. Then do the funding with more like a $10 price (less discounts and warrants) and hope for the best. The balance sheet is not going to fix itself, and doing incremental steps with a stock trading under $1.00 is only going to end badly. It might end badly anyway, but at least there is a fighting chance with an investable price.
Matt, honest question here. Why wouldn't Mann Foundation increase credit line $100 million rather than approve 20-1 reverse split? This would give about a year for mnkd to get scripts to increase and see if afrezza can succeed in market place. Lets say Mannkind Foundation already invested $900 million at $1 and reverse split is approved by BOD then wouldn't Mann Foundation net worth drop to $45 million? Why would they do that?? Part of Al's last wishes was give mnkd every chance to succeed so in my opinion they would rather increase credit line than R/S. |
|
|
|
Post by saxcmann on Sept 21, 2016 20:49:55 GMT -5
If the Mann foundation would up the loan to say 100 million, that would get us back to a a share price with good volume to even enable us to sell additional shares to bring in an additional $100 million . We would not only be set with cash for another year but we would also have enough to do some serious marketing and keep the ball rolling long enough to be profitable with sales in the US and oversees. That's what is going to happen by the way. That's my story and I'm sticking to it. I think your story is close. Besides $100 million from Mann Foundation we get another partnership deal (dexcom and/or Epi?), RLS milestone, and maybe Sanofi settlement within 6 months. Scripts will grow and B/O offer will come down the road maybe end of 2017 or 2018. From what I hear mnkd isn't planning on closing shop anytime soon. They are hiring doctors to speak and moving forward with Mike'so strategy. |
|
|
|
Post by saxcmann on Sept 19, 2016 12:11:03 GMT -5
Wow...just when you thought... Like they say, "s__t happens," but why did it take 20 months to realize there was such an issue? No real issue. Docs received plenty of inhalers. just not in same pkg. |
|
|
|
Post by saxcmann on Sept 18, 2016 20:45:25 GMT -5
This has been such a long time coming following 8,000 trial participants over ten years, delayed action by the FDA who mandated antiquated trial protocols be used, a failed Sanofi partnership, relentless bashing, market manipulation and the passing of the great Al Mann. Fortunately there's a reason Afrezza and MNKD have survived through all this and it's all based on superior science. We now know Afrezza is the greatest advancement in a generation for treating the world's largest disease but now it's time that the world learns this as well. It appears Matt, Mike and team have made a monumental effort to resurrect knowledge and scripts with the 2.0 launch that began slowly in July. At the time, they said we should begin seeing a rise in scripts in the September and October time period. Now we're here and the next month is going to provide the answer. I remain optimistic that the forthcoming success will be comparably as great as the pain of the past has been. Diabetics first and then longs deserve the reward that has been a long time coming. Like your enthusiasm but sorry I have to disagree. Dont see this as a binary moment at all nor do I believe that MNKD sees it that way either. I think that this will be a longer process than many of us think or are prepared for. If you are expecting to see the answer in October I think you may be setting yourself up for disappointment. October is still too early to assess script trends since the direct to patient efforts are just beginning and we just also found out that the packaging cartridge/inhaler issue will not be solved until November according to Matt. Some particular individuals may see October as a binary moment in which to decide to stay or get out which is up to them but I don't think this describes the process of what we are seeing as a whole including MNKD's timeline. Not sure about binary moment either but I do think we'll have a significant jump in scripts in October. If we can't get NRx's above 200+ we are not trending fast enough in my opinion. 60 reps should be able to achieve 1 prescription per week from docs. |
|
|
|
Is it me?
Sept 16, 2016 19:20:56 GMT -5
via mobile
Post by saxcmann on Sept 16, 2016 19:20:56 GMT -5
Or disorientation,from all the punishment he's taken from owning this stock, mistaken for insight. More than a hunch but honestly Surplus is probably right. I have headaches lately from this stock! |
|
