|
|
Post by kc on Feb 3, 2016 19:17:20 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative. The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first. I hope it's TEVA in Israel and they take it for a test drive for that market. Israel recognizes FDA with no additional regulatory problems. |
|
|
|
Post by BlueCat on Feb 3, 2016 19:19:00 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative. The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first. I hope it's TEVA in Israel and they take it for a test drive for that market. Israel recognizes FDA with no additional regulatory problems. And would imagine the locals that bought in through TASE and now own a piece of both might be pleased with that potential. |
|
|
|
Post by kc on Feb 3, 2016 19:18:58 GMT -5
I'd add the one that really disappointed me... no discussions with payers until after the transition... i.e. MNKD won't even get a perspective on probability of getting better coverage until Q2. Are they going to decide to reduce the price without even having these discussions? Maybe reducing to SQ RAA level is no brainer... but I can't imagine payers would adjust formulary just based on change in price if MNKD isn't talking to them. I take that as no disclosure versus no discussion. I am sure they are using this time to get all their ideas and plans in line on how to address payers. |
|
|
|
Post by mnkdfann on Feb 3, 2016 19:23:32 GMT -5
are Mannkinds hands completely tied? they will not get afrezza back until april 5th. Hands tied until april 5th? Hands tied? Judging from your avatar, I thought you were pro that sort of thing.  |
|
|
|
Post by taylor810dn on Feb 3, 2016 19:28:13 GMT -5
Here is what I got, maybe fills some blanks
Take away points from call worth noting:
Matt
Estimated date to complete Afrezza Transfer is April 5th, may be later. MNKD can not make any related filings or do any advertising until after the transfer. MKND is preparing to market Afrezza on their own.
SNY still have all US and foreign rights to Afrezza until transferred.
Kenetic study and interpatienct study were “quite positive”, pediatric study underway.
Social media can not be used to promote Afrezza in any way due to the FDA black box label restrictions.
Diabetes care centers will be in New Jersey, major metro areas and will have spirometry testing capability.
The advisory council is currently being formed.
Foreign expansion is being pursued and MNKD is in multiple discussions, most would be countries that do not require additional trials, but they are in discussions with a company in a country that will require additional trials.
RLS is not connected to MNKD or Al Mann, and has been in business for some time, but just recently changed their name. MNKD retains all rights to Technosphere except for the specific drugs negotiated with RLS. RLS was chosen for their pedigree and experienced management team. A reverse merger with RLS is NOT being considered.
Ray
The dry powder/technosphere technology will have a competitive edge due to the rapid absorption rate and it is not immediately metabolized by the liver.
Currently 3 candidates for this technology to market—PAH for pulmonary hypertension, Epinephrine for anaphylaxis, etc. and Palonosetron for chemo induced nausea. All 3 will have initial studies completed 2nd quarter this year with trials staring 1st quarter of 2017.
MNKD patent portfolio includes a whole bunch of categories and I couldn’t write that fast but the patents for each category include—914, 510 for Afrezza, 188 for patient ?, 388, 82, 114, 48, 90 miscellaneous, and 600 more pending. Key here is a boatload of patents in the portfolio.
Matt answering questions:
Quarterly call will be in a couple weeks. Cash issues are being addressed from all angles and trying to reduce all obligations, including suspending Matt’s and Rose’s salaries? BK has not been considered and things would have to get much worse for it to even become a consideration.
Matt explained the delisting and that at least a 6 month extension to the original 6 months is easy to obtain with a valid reason.
MNKD will not address rumors
MNKD is not considering a reverse split for the stock price and is confident it will take care of itself as the future developments materialize.
MNKD employees/officers cannot currently buy MNKD stock per FCC rules.
The lawsuits are common to all equity issues like MNKD stock has been through and MNKD is insured against any related liabilities.
Stock manipulation—MNKD has reported the unusual trading patterns/activities to the SCC and is aware that they have started an investigation. MNKD is also using tools of their own to investigate and expose the stock manipulation.
Questions from audience:
J.P.Morgan—They do not understand the secrecy behind RLS. Matt emphasized they are a legit company, not a shell company or associated with Al Mann, they have been in business for some time, however they just went through a name change. The secrecy is part of a request of RLS but that may change in the near term.
Expanding on the financing issues—Matt indicated they will have 59-60 million dollars cash at the end of 2016. MNKD will take over the financial costs for the trials after April, but those costs will not be significant.
Griffin Securities—What are the costs associates with SNY/Affrezza until April? Matt indicated it would still be the 65/35 split responsibility. The monthly costs until the divorce will stay about the same as they have been. On the Marketing & sales manager, wished they had found one last week, but have spoken to a couple candidates and are aggressively pursuing a manager.
Piper Jeffrey—Expand on early tech assessment stages for the 3 TS candidates. Ray answered that one as well as the question of how big the team, no size mentioned but it is all in-house FTE. Matt also re-iterated the black box waring prohibits the use of social media for advertising.
Goldman Sachs—Expand on the steps for the transition of Afrezza. Matt indicated everything will start at the Afrezza return date which is tentatively April 5th. He also indicated that any bankruptcy filing is not related to the transfer of Afrezza, and that no new business developments could be announced as part of this conference call.
That is what I remember, no claim to accuracy.
|
|
|
|
Post by peppy on Feb 3, 2016 19:30:28 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative.The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first.  . Other things that are not surprising, over the last few weeks I've encountered diabetics, family members of diabetics, phlebotomists, among others that still have no idea that this is available let alone been on the market for coming on a year now. I literally have had them ask me if they can take a picture of the dreamboat to bring to their physician, etc.
Anyone that thinks/claims SNY has any case whatsoever of a commercially reasonable effort to market Afrezza is FOS. Matt was pretty diplomatic in his description of his thoughts about that as well. When one of their (SNY) own reps is willing to make a change because they still believe this is a phenomenal product for diabetics, well like I said in a previous post, that speaks volumes. A few magazine ads, etc. does not cut the mustard for a revolutionary breakthrough product...label restrictions and all included. Personally, I would have loved to ask Matt what his and/or Al's thoughts were about the this www.aboutlawsuits.com/levaquin-rico-lawsuit-93357/ which has been brought up but shouldn't be taken lightly IMO. I think Matt is trying to negotiate the ending terms with Sanofi. I heard Matt say, no reverse split. I heard Matt say bankruptcy in not being talked about. I did not hear Matt talk about a sale, or dispel the rumor that Mannkind was looking for a buyer.
|
|
|
|
Post by obamayoumama on Feb 3, 2016 19:31:06 GMT -5
Until April 5th at the earliest, but Mannkind may request an extension. Afrezza is not covering it's costs and while the agreement remains in place Sanofi picks up 65% of the costs and loans Mannkind the remaining 35%. For that reason I would want to defer the exit as long as possible while I set up 2.0 Good point. Anyone have a list of Countries that wouldn't require additional testing that they could get a regional partner started with? From the call it sounds like they could start negotiations with a regional partner but couldn't start selling in those countries until they are done with SNY |
|
|
|
Post by kball on Feb 3, 2016 19:38:32 GMT -5
But it seems there are too many restrictions. I have said exactly the same, but now knowing they can't talk to payers I can't imagine that the delay would be worth it. Talking to payers has to be near the top of what I would think would be their list of setting up 2.0. Also on the list would be talking to FDA about superiority trials... would they still really be trusting SNY to do that? What comes to mind is Mannkind trying to perhaps push forward an agreed settlement payment before taking back afrezza? But i'm not a lawyer, just another schmuck trying to figure some part of this shtt out. And be right for once |
|
|
|
Post by myocat on Feb 3, 2016 19:38:37 GMT -5
Thanks Dudley for the summary.
Overall, it's an informative CC where Matt and co outlined the steps going forward.
The pros will always find some light at the end of the tunnel.
I don't expect MNKD PPS really moves the needle until few moons from here. However, it's a good time to accumulate.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Feb 3, 2016 19:39:48 GMT -5
That call was a disaster from a financial point of view. Hands tied till april, Bk is a last resort not consider it yet (oh boy, that's code folks and not the kind one wants to hear), and, well, the rest is what it is. My point is simple - BK in 2016 appears inevitable. Evidence? All of it. Cash position, hands tied, insurance coverage won't get fixed in 2016 (that's a certainty as much as anything can be certain in this world), and matts words which are as conflicting as mnkd's message the last year and a half (sales will pick up, DTC is coming in august, embarrassment of riches, additional deals, cash is not a problem, the august converts are no big deal, very little clarity on tase, the relationship with sny is going wonderfully well, and on and on). What's different right now vs when hakan was CEO? Answer - a different body in the CEO position. Otherwise, nothing is different. No partners, no cash infusion, and at a time when they desperately need to get sales rolling mnkd's hands are tied for the next couple of months.
Unlike personal finances where one can continue their spending lifestyle right up until you enter bankruptcy court, it doesn't work out that way for public companies. Creditors to public companies are very smart and when they see a sinking ship, they take whatever actions to recover their funds as quickly as possible. That's why mnkd won't go until the last dollar is spent. Creditors will force BK while there's still some cash to go around. It also completely kills doing deals with other companies. Why? Their finance people will take a look, and, just like you and I going to a garage sale, they will know they can go after mnkd's assets in BK. Why buy today at 400 million when they could buy it in 6 months at 100 million or less? This is what it is and you can hate the messenger. But it's a business reality.
|
|
|
|
Post by bioexec25 on Feb 3, 2016 19:48:55 GMT -5
Davinci - Hard to argue this is becoming a more likely certainty, but most of the logic (or at least mine) that supports the BK outcome is based on an absence of another deal or even a settlement with Sny. If the finances are dealt with through year-end this gives 6-7 months without shackles and full on sales effort with either a partner or most likely a contract commercial sales/dist.
|
|
|
|
Post by esstan2001 on Feb 3, 2016 20:05:41 GMT -5
But it seems there are too many restrictions. I have said exactly the same, but now knowing they can't talk to payers I can't imagine that the delay would be worth it. Talking to payers has to be near the top of what I would think would be their list of setting up 2.0. Also on the list would be talking to FDA about superiority trials... would they still really be trusting SNY to do that? DBC, in the talk, I did not catch the exclusion from talking to payers... they can not negotiate anything but I would think they could issue a letter of intent to drop price to X once there is a change of control... or is it that the payers will not speak with Mannkind until they are the owners... They need to break some rules at least on this side of the fence, as it is clear they will not push the envelope on the regulatory (FDA label) side... seems he made it clear that they need some innovative approach to social media and networking getting out the word on how effective and life changing this is, without the company facilitating this in any direct or even indirect way. |
|
|
|
Post by esstan2001 on Feb 3, 2016 20:09:37 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative.The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first.
Anyone that thinks/claims SNY has any case whatsoever of a commercially reasonable effort to market Afrezza is FOS. Matt was pretty diplomatic in his description of his thoughts about that as well. When one of their (SNY) own reps is willing to make a change because they still believe this is a phenomenal product for diabetics, well like I said in a previous post, that speaks volumes. A few magazine ads, etc. does not cut the mustard for a revolutionary breakthrough product...label restrictions and all included. Personally, I would have loved to ask Matt what his and/or Al's thoughts were about the this www.aboutlawsuits.com/levaquin-rico-lawsuit-93357/ which has been brought up but shouldn't be taken lightly IMO. My hope is that they can collectively use all this to leverage a good separation agreement payment, so that no legal action is worth pursuing (it almost never is). |
|
|
|
Post by kball on Feb 3, 2016 20:11:30 GMT -5
That call was a disaster from a financial point of view. Hands tied till april, Bk is a last resort not consider it yet (oh boy, that's code folks and not the kind one wants to hear), and, well, the rest is what it is. My point is simple - BK in 2016 appears inevitable. Evidence? All of it. Cash position, hands tied, insurance coverage won't get fixed in 2016 (that's a certainty as much as anything can be certain in this world), and matts words which are as conflicting as mnkd's message the last year and a half (sales will pick up, DTC is coming in august, embarrassment of riches, additional deals, cash is not a problem, the august converts are no big deal, very little clarity on tase, the relationship with sny is going wonderfully well, and on and on). What's different right now vs when hakan was CEO? Answer - a different body in the CEO position. Otherwise, nothing is different. No partners, no cash infusion, and at a time when they desperately need to get sales rolling mnkd's hands are tied for the next couple of months. Unlike personal finances where one can continue their spending lifestyle right up until you enter bankruptcy court, it doesn't work out that way for public companies. Creditors to public companies are very smart and when they see a sinking ship, they take whatever actions to recover their funds as quickly as possible. That's why mnkd won't go until the last dollar is spent. Creditors will force BK while there's still some cash to go around. It also completely kills doing deals with other companies. Why? Their finance people will take a look, and, just like you and I going to a garage sale, they will know they can go after mnkd's assets in BK. Why buy today at 400 million when they could buy it in 6 months at 100 million or less? This is what it is and you can hate the messenger. But it's a business reality. Sums up my thinking at this point. Better than i could. Not FUD, REALITY. Penny stock. Enormous losses. ....Unless a payment by Sanofi and soon |
|
|
|
Post by mindovermatter on Feb 3, 2016 20:15:04 GMT -5
Bankruptcy note. Matt said it would be last resort but that no plans for it. My read on that "no plans" for it is he hopes that negotiation with lenders etc will help buy time but what if those lenders wish not to change the current terms? That BK as last resort is going to come into focus pretty quickly. I know some on here thing the call went well but I do not. Not at all because Matt allowed uncertainty to become a large part of the call. It's why the AH price is tanking and why tomorrow has the makings of a very bad day for the stock. Shall we use the negotiations on the Aug debt as an example? That went well..... Excellent point. Might need to rename the company Botchedkind. |
|
. Other things that are not surprising, over the last few weeks I've encountered diabetics, family members of diabetics, phlebotomists, among others that still have no idea that this is available let alone been on the market for coming on a year now. I literally have had them ask me if they can take a picture of the dreamboat to bring to their physician, etc.
