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Post by yossarian on Feb 4, 2016 0:17:13 GMT -5
I listened to the conference call and found little factual information to be optimistic about. Matt confirmed that Mannkind can do nothing with AFREZZA until they get the franchise back from Sanofi. He gave no date as to when this is likely to happen. Asked about Mannkind's financial situation he said wait for the quarterly report. Unasked was whether Mannkind had the resources to do anything with AFREZZA once they get the franchise back. I've seen bandied about that this could happen in April and under the terms of the partnership agreement should happen no later than June. So in the meantime AFREZZA is left to limp along with a partner who is leaving thus has no incentive to really do anything in regards to marketing it. If it takes until June to get the franchise back, Mannkind may be just about out of money. Nothing said at the conference call provided anything to refute this.
There was a little information given about Receptor Life Sciences except to say it once had another name, which he did not disclose. He did indicate a Mannkind employee was with Receptor. Otherwise, nothing.
Two drugs were named as being developed for Technosphere. No time line was given. I've seen some posts that say FDA approval would not be needed for already approved drugs. I have that dubious. It's a little like saying the hypodermic needle was approved so had drug administered with it does not need FDA approval when administered with it. I would hope the FDA would be concerned with whether a new method of administration posed any new health concerns.
All in all, I found little reason for optimism in the conference call.
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Post by lorcan458 on Feb 4, 2016 0:41:06 GMT -5
Matt confirmed that Mannkind can do nothing with AFREZZA until they get the franchise back from Sanofi. That isn't accurate. Matt can email (for records) his Sanofi contact and say, we strongly believe lowering the price immediately to be on par with injectable insulin is the best way to negotiate tier 2 coverage. We have ample evidence that patients dropped Afrezza solely due to cost. Will you lower the price immediately? If they say no, now we build a paper trail for the lawsuit. Matt needs to ask and make Sanofi deny the request. They deny it at their own peril. He gave no date as to when this is likely to happen. That isn't accurate. He said April unless Mannkind requests an extension. Asked about Mannkind's financial situation he said wait for the quarterly report. That isn't accurate. He said they have between 59 and 60 million once the audit is done. So in the meantime AFREZZA is left to limp along with a partner who is leaving thus has no incentive to really do anything in regards to marketing it. That isn't accurate. Sanofi is under the spotlight with a lawsuit for sandbagging already. If Mannkind makes a request, like lower the price, and Sanofi denies it, they are opening a huge area of attack for the Mannkind lawsuit, should it be filed. Two drugs were named as being developed for Technosphere. No time line was given. That isn't accurate. There was a timeline graph for the stages of development accurate down to the quarter.
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Post by 4allthemarbles on Feb 4, 2016 0:49:27 GMT -5
I believe the date Matt used was April 5th...
Make no doubt this will be a long road, but the original post is way off.
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Post by yossarian on Feb 4, 2016 0:54:10 GMT -5
From the Conference Call Transcript: " In order to clear up any misconception until the transition is complete, MannKind will not be promoting Afrezza neither can we affect any change in sales strategy, pricing or negotiate with peers. MannKind is also unable to make any regulatory filings including filing for approval in other jurisdictions until the NDA is transferred back to us." Mannkind can do many of things you say in your post. Laying out a paper trail to sue Sanofi is certainly one of those things. But I am dubious that that makes Mannkind an attractive investment. Look I have a lot of money tied up in Mannkind, but I'm beginning to be convinced that who is going to benefit from AFREZZA and Technosphere is going to be the entity that gets them either in bankruptcy or in a fire sale. I hope I'm wrong, but . . . You are correct in pointing out that Mannkind may get AFREZZA back in April. Again from the Conference Call Transcript: "MannKind is targeting April 5th as the transition date of the license to develop and commercialize Afrezza but we may request that Sanofi agree to a later date. There are many factors that influence when the transition will occur including a myriad of regulatory, commercial and development activities many of which involve third-party vendors, our regulatory authorities and out of which needed to be transferred in a smooth and coordinated fashion." Hopefully Sanofi is shooting for the same date. As to Mannkind's financial situation, you are correct that Matt said Mannkind said, "As far as cash, the only guidance we’ve given at this point realizing we’re still under audit and closing the books, so one of the few numbers you can handle on pretty quickly is cash. So I went not very far out of the limb and said it was going to be between 59 million and 60 million at the end of the year. So I said that previously, I’ll repeat that here, it’s true. Nothing has changed there." But that does not tell me much about Mannkind's financial situation. How much will be eaten up between the end of the year and when Mannkind gets the AFREZZA license back? ? How much will Mannkind need to market AFREZZA in a better way than Sanofi? That is what I was referring to when I said nothing was said about Mannkind's financial situation. I am sure Mannkind can continue until its gets the AFREZZA license back, but will it have an financial resources left to meaningfully exploit it? The once area of optimism was on international expansion. Matt said: "Now regarding international expansion, prior to signing the agreement with Sanofi, MannKind was in discussions with multiple international groups representing substantial regional markets. Those discussions have now been restarted in recent weeks with our priority being those regions in which we can use our U.S. approval as a basis for regulatory submission without additional trials. As these plans firm up, we’ll be sharing them with you." It's a little disconcerting that Sanofi apparently did not pursue this.
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Post by patten1962 on Feb 4, 2016 6:46:00 GMT -5
I am NOT a money guy but I did not get the impression from listening to Matt that they will be running out of money right after Sanofi deal is over in April. Sounds like he has plans in place restructuring debt and making some money and foreign markets. If I am incorrect please explain.
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Post by mindovermatter on Feb 4, 2016 6:49:26 GMT -5
I am NOT a money guy but I did not get the impression from listening to Matt that they will be running out of money right after Sanofi deal is over in April. Sounds like he has plans in place restructuring debt and making some money and foreign markets. If I am incorrect please explain. 4 things. Seems the only thing outside of SNY moving Afrezza up to the split day is the clinic that hopefully will open soon that will be successful and help slowly increase Afrezza scripts. Next, possible negotiation of money from Sanofi (not a sure bet). And then your points of restructuring debt (if that happens) and hopefull "in place and ready to run" deals with foreign countries to increase volume.
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Post by falconquest on Feb 4, 2016 7:26:55 GMT -5
My take is that nothing is going to happen quickly. Ok, the clinic may open in New Jersey but that isn't going to add to the bottom line in any sudden fashion. Matt seems to be headed in the right direction it's just that the steps to generate revenue are longer term and the cash position requires more near term solutions. This disparity is a huge negative right now. I think they have to partner/sell Afrezza (which they can't do until at least April)..........and soon!
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Post by wmdhunt on Feb 4, 2016 11:17:32 GMT -5
Totally in absolute spite of the negativity here I just bought more MNKD. I expect in a year to be pleased with my investment and find the current level of PPS a bargain. Matt is doing all that he can and IS taking the company in the right direction.
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Post by dreamboatcruise on Feb 4, 2016 11:27:59 GMT -5
I am NOT a money guy but I did not get the impression from listening to Matt that they will be running out of money right after Sanofi deal is over in April. Sounds like he has plans in place restructuring debt and making some money and foreign markets. If I am incorrect please explain. Probably 95% of companies that go bankrupt have plans to restructure debt and make money. Bankruptcy occurs when those plans do not come to fruition. You are correct that insolvency will not occur in Apr. MNKD has stated that their available cash should get them into second half of year, so based on what is stated the implication is that there would be no bankruptcy before July. Matt has suggested that they have means of extending this, but short of putting everything into hibernation mode pretty quickly they aren't going to have many options by the time the second half rolls around if we have not received money from some partnership or distribution deal or settlement.
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Post by dreamboatcruise on Feb 4, 2016 11:38:21 GMT -5
I am NOT a money guy but I did not get the impression from listening to Matt that they will be running out of money right after Sanofi deal is over in April. Sounds like he has plans in place restructuring debt and making some money and foreign markets. If I am incorrect please explain. 4 things. Seems the only thing outside of SNY moving Afrezza up to the split day is the clinic that hopefully will open soon that will be successful and help slowly increase Afrezza scripts. Next, possible negotiation of money from Sanofi (not a sure bet). And then your points of restructuring debt (if that happens) and hopefull "in place and ready to run" deals with foreign countries to increase volume. How many doctors do you think this clinic might have and how many scripts does one doctor write in a day? I don't think these clinics will make much difference in script numbers for some time... there would need to be many of them and that will take time. My best hope for the clinic is that it will quickly attract some media attention and maybe being a separate entity from MNKD somehow patient results can be better highlighted. I had hoped it might be some new reimbursement model with insurers... paid for actually lowering patients A1c. That would probably be great free media... "pioneering new business model in healthcare". My fear is that these will not even come to fruition. Someone posted an article about how many other attempts at diabetes clinics, even ones run by well established hospitals, have been closed down because they couldn't make the finances work with restrictions on reimbursement from insurers. Worst case is that these 3rd party investors come to the conclusion that it would be throwing money away and don't open them. That would be a huge black eye for MNKD at a time it doesn't need it.
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Post by rvc on Feb 4, 2016 11:53:42 GMT -5
it sounded to me that Mankind is in no hurry to get back the marketing rights from SNY. Matt mentioned April 5th as the earliest date, but he also emphasized that Mankind could request that the date be pushed back. Maybe it was his tone, but it appeared to me that Mankind wasn't in any particular hurry to get back the marketing rights. I would have been much more hopeful about MNKD's future if Matt had indicated that he was looking forward to the marketing shift from SNY to MNKD, but I didn't get that impression.
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Post by bearcatmax on Feb 4, 2016 11:57:43 GMT -5
it sounded to me that Mankind is in no hurry to get back the marketing rights from SNY. Matt mentioned April 5th as the earliest date, but he also emphasized that Mankind could request that the date be pushed back. Maybe it was his tone, but it appeared to me that Mankind wasn't in any particular hurry to get back the marketing rights. I would have been much more hopeful about MNKD's future if Matt had indicated that he was looking forward to the marketing shift from SNY to MNKD, but I didn't get that impression. I agree with this. I have to believe MNKD is going to get some sort of cash settlement from SNY and the details of this amount might have been redacted in the original agreement. Matt knows that they will be receiving some sort of amount of %. Just speculation but it might be why they don't feel too rushed and want to make sure the transition is smooth.
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Post by dreamboatcruise on Feb 4, 2016 11:58:25 GMT -5
it sounded to me that Mankind is in no hurry to get back the marketing rights from SNY. Matt mentioned April 5th as the earliest date, but he also emphasized that Mankind could request that the date be pushed back. Maybe it was his tone, but it appeared to me that Mankind wasn't in any particular hurry to get back the marketing rights. I would have been much more hopeful about MNKD's future if Matt had indicated that he was looking forward to the marketing shift from SNY to MNKD, but I didn't get that impression. It would certainly be a cash burden on MNKD once they take it back. Maybe they are looking to solidify their new strategy and hoping for a new partner before taking that on. They won't have much resources for sales/marketing if they got it back now. I'd say it would be no brainer to postpone if they could be working behind the scenes with payers, the FDA for superiority trials and have the clinics get up and running. But it appears the first two aren't possible. MNKD may have conflicting goals and may be playing it by ear.
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Post by dreamboatcruise on Feb 4, 2016 12:05:29 GMT -5
it sounded to me that Mankind is in no hurry to get back the marketing rights from SNY. Matt mentioned April 5th as the earliest date, but he also emphasized that Mankind could request that the date be pushed back. Maybe it was his tone, but it appeared to me that Mankind wasn't in any particular hurry to get back the marketing rights. I would have been much more hopeful about MNKD's future if Matt had indicated that he was looking forward to the marketing shift from SNY to MNKD, but I didn't get that impression. I agree with this. I have to believe MNKD is going to get some sort of cash settlement from SNY and the details of this amount might have been redacted in the original agreement. Matt knows that they will be receiving some sort of amount of %. Just speculation but it might be why they don't feel too rushed and want to make sure the transition is smooth. Wishful thinking. There has to be some legitimate reason for the SEC to allow things to be redacted. Sales projections one can say legitimately are something that business don't ordinarily want their competitors to know... hence we know those were redacted. A break up fee is exactly the type of thing that shareholders of both companies should know and there is no legitimate reason I can think of to argue that SEC should allow it to be redacted. It is folly to concoct some dream and always think it is is the redacted portion of the agreement. It's contained buyout plans, investment plans and now break-up payments... if we believe the wishful thinking on this board. I mean, for all we know that redacted portion names me explicitly as recipient of a new car simply for supporting MNKD for so long... can anyone prove that wrong? I'm going to sit in my driveway now.
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Post by irrationalexubera on Feb 4, 2016 13:20:20 GMT -5
love ya, DBC! i'm coming over to party in the driveway with my bottle of angel's envy.
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