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Post by babaoriley on May 12, 2014 18:50:24 GMT -5
Let's get some reaction on the conference call. I have not heard it yet, but I'm sure many here have. I've already heard some pretty good stuff that was said, but let's get some commentary going. I will listen by tonight and look forward to it! You know you'll get an objective view from Baba!! LOL! Whatever we think, I didn't see much movement in A/H trading, perhaps tomorrow morning we'll see some significant reaction, hopefully of the green variety!
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Post by mdcenter61 on May 12, 2014 20:21:46 GMT -5
I was traveling and unable to listen in, so I would love some input from this Board; typical mindless pumping and bashing at YMB
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Post by spiro on May 12, 2014 20:43:13 GMT -5
Good question Baba, today's conference call was certainly very interesting to say the least. My optimism was reinforced for the most part. IMO, Al Mann basically told us that the FDA is probably leaning towards an approval within weeks. I also believe that MNKD has a partner lined up contingent upon FDA approval and label. Some sort of announcement regarding a partnership could happen soon. I believe the shorts are now in an extremely risky position. After FDA approval, the shorts could be faced with a barrage of favorable press that could drive the stock price well over $20. Just to list a few:
A. Immediate partner announcement or maybe a $20 billion plus buyout. B. Foreign country order C. Technosphere contracts, how about a $500 million partnership to develop a pain product. D. European NDA E. Analyst upgrades F. Strong institutional buying.
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Post by ashiwi on May 12, 2014 21:04:20 GMT -5
With the overwhelming positive ADCOM in the back of my mind, today's conference call was another confidence boost. It left me with a feeling that FDA approval and partner were a given. Labeling and post approval safety trials just had to be ironed out and finalized. There was even mention of Phase 4 for kids. Phase 4 can only be possible after FDA approval. Whether it's 2 weeks or 9 weeks, there will be a press release one morning that Afrezza has been approved by the FDA and MNKD has partnered with ?...
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Post by lynn on May 12, 2014 21:11:25 GMT -5
Baba, For what it's worth I just finished listening to it . Mind you this is my first experience ever listening to one of these so my feed back is with fresh ears ,) & may not mean much . I wish I could have seen them in person as one can notice so much more by body language ect, but I sensed total confidence from Al , Matt & Hakan. In fact Al mentioned "when" regarding approval rather than "if" . Granted Al is a very confident Man so that could just be him . But I believe it was Hakan who said re:ADA conference something about how it would depend on the timing of approval, which was also a very confident statement . It sounds to me that Al has a lot of respect for us shareholders and can't wait to fill us in , but he obviously needs to keep quiet until the deal is done. I can't wait to see him in person at the SH meeting next week !! & I hope the true potential of Afrezza & Technosphere are realized while he is still with us so he can bask in the glory of his latest & greatest contribution to Mankind. If we only had more like him I think we'd live in a very different world ( not to get political,)) . But he is quite an amazing human being ! Lynn
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Post by 4allthemarbles on May 12, 2014 21:18:43 GMT -5
With the overwhelming positive ADCOM in the back of my mind, today's conference call was another confidence boost. It left me with a feeling that FDA approval and partner were a given. Labeling and post approval safety trials just had to be ironed out and finalized. There was even mention of Phase 4 for kids. Phase 4 can only be possible after FDA approval. Whether it's 2 weeks or 9 weeks, there will be a press release one morning that Afrezza has been approved by the FDA and MNKD has partnered with ?... Ashiwi- I totally agree. The level of confidence exhibited today on the call was like a breathe of fresh air. If we get early FDA approval, it would be about 4 weeks. AND I think they may still get a booth (or at least pay for one) for the ADA meeting. What a great thing it would be if MNKD could go to the ADA with an Afrezza approval. Very positive Adcom. FDA approval. Partnership. Years in the making now down to a few weeks. I am very positive.
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Post by 4allthemarbles on May 12, 2014 21:22:11 GMT -5
Oh, 1 more thing. Phase 4 sounded like it was almost a given. The FDA wants to view the trial/ study for kids. I like it.
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Post by rockyp on May 12, 2014 22:25:54 GMT -5
FWIW, here are the things that struck me: 1) As others have noted, Al, Hakan and Matt all seemed to be extremely confident in FDA approval and a partnership. Al almost came off as giddy I thought. Obviously the AdCom vote was a big contributor to their confidence, and Al even mentioned the AdCom vote a couple of times. Still, the Adcom was a month ago. I doubt they would be riding that high if they didn't have some other positive information on which they were.
2) They used words like "partnership" and spoke of parties interested in "commercializing Afrezza". I don't think I ever heard them use like "buyout" or even hint at an overall deal on Technosphere. For me, that is a positive because it leaves more long-term potential.
3) I thought the responses to the question about a contingency plan in the case of no partnership were pithy. Hakan: "We feel comfortable with our partnership opportunities." Al: "We are not worried. At least I'm not."
4) There were some sound bites that could be taken out of context if someone needed to submit a 500-word hit piece by 8AM in order to get money to pay the rent. I think it was Al who said it was an "awkward time", referring to having a lot going on but not being able to discuss it publicly. They made the statement that they "cannot provide substantive information about certain key subjects" and they "cannot discuss any […] progress". There was a comment by Matt that the cash situation could have been "scary" by July 15 if they hadn't gotten the extra $20M from Deerfield . In context, I don't think there is anything negative in the comments, but again, those are sound bites that could be taken out of context. It will be interesting to see tomorrow if there are still folks trying to spin the news into doom and gloom.
5) The small positive movement in the share price during afterhours trading would seem to suggest no one heard anything really surprising. Or more precisely, no one was surprised by what they didn't hear. I take this as a good thing, since in the past the lack of information at news conferences has been taken as a negative.
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Post by seanismorris on May 12, 2014 22:48:27 GMT -5
There was nothing negative on the call...
I agree approval is now "when" not "if".
I'm not sure what the 'shorts' are thinking at this point, except they seem to think there will be a stock sell off after approval. Personally, I'd don't see it happening. MNKD is not a stock that is in bubble territory. Even on the conference call there was a stand-in analyst asking questions. Which to me suggests the stock is undervalued and the companies story unappreciated.
If you want to try find negatives on Mannkind, it is true that there has been considerable dilution, but the dilution has often been warrants being turned into common shares. That doesn't sound all that negative from where I'm standing. Also, we (as investrors) don't really know how to value a company that has no sales... But, we do know that the oportunity is huge and it's very possible that the yearly sales could exceed the current market cap. For that potential to be realized, Mannkind has to sell 'best in class' mealtime insulin and have support from doctors, and diabetes organizations.
Alfred Mann drops some names on the call including American Diabetes Association, The American Association of Clinical Endocrinologists, Juvenile Diabetes Research Foundation, Closed Concerns, Diatribe, and Take Control of Your Diabetes.
That doesn't sound like Mannkind is going to have trouble finding the support it needs to successfully market Afrezza.
Another take take-away from the call is a partner is already lined up, and Mannkind thinks (is possible) that they will be able to announce it before FDA approval. Personally I have my doubts of that occurring... But it is possible that a partner could be that confident and try to get in a deal so they can jointly market Afrezza at the upcoming American Diabetes Association meeting.
Also discussed was Mannkinds preparedness on the production side. Everything is proceed as planned for a product launch less than 6 months after approval (if not sooner). Around that same time Mannkind has a good chance that the 9 unit cartridge (from a supplemental NDA) will be available but the 12 unit is expected to take longer.
I'd be satisfied with the MNKD at: $12 after approval and the partner announcement. $15 - $20 after Afrezzas launch and pain (Technosphere) clinical trial announced. $25 global launch of Afrezza early 2016 + positive data from the pain trial
I'd also take Spiros 20B buyout, but that may be a bit high unless the pain pre clinical trial data is fantastic
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Post by babaoriley on May 13, 2014 1:41:24 GMT -5
Some very nice posts re the conference. To me, the cc did not get me any closer to believing the FDA will approve; I've thought it likely since AdCom and Al's comments, although positive, did not add to my comfort there. I've seen and heard Al sound like that and say things like that before, and overshoot, so that's why.
As to partnership, some encouraging words, no doubt about that. It did sound like more than one or two candidates have exhibited strong interest - if what sounded like, actually is, then that is very, very good, because under those conditions (as opposed to one suitor), Al may get what he needs to pull the trigger on a partnership.
The boys sounded confident and with reason. Will the cc move the stock tomorrow? If I had to say, I'd say it will move it positively, but not more than 5%, not that 5% is chopped liver. If I had to guess, I'd say up about a dozen pennies at close, coming off a high of up over $0.20.
I like seanismorris' price targets, very reasonable and reachable. The one bit of rocket fuel he did not include was an order from a foreign country - that would be good for an extra 15-30% right there.
As usual, I'm not as excited or blown away as some, but nonetheless happy with what I heard. I hold some long put contracts for August, strike price of $7, as a little insurance in case the worst happens. I could sell them tomorrow and do okay, as they will likely and hopefully be worth zero come August. I will not sell them all based on the cc, but perhaps would sell a few... and perhaps a few more after the meeting if all goes well there, too.
Looking forward to hearing it all again and more on May 22, and actually seeing it, too! Perhaps we will be able to gauge the delta of good feelings among management between this call and the meeting.
Don't mess with me for this post, you have no idea what my childhood was like! LOL!
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Post by harshal1981 on May 13, 2014 7:38:04 GMT -5
Not sure if any of you paid attention to the answer from Al about replying to FDA in collaboration with potential partners. To me that is the single most indication that they have locked down their partner or buyer. I can't believe one can consult 5 different "potential" partners what they are submitting to FDA as response to the quires related to finalizing label and post marketing studies. Its just not practical / possible considering the nature of information that they would have to discuss. In my opinion, the fact that Al clearly mentioned in his reply that they are working in collaboration with those that they believe are their potential partners in assembling replies to FDA, it is clear indication that its all about fine tuning the exact figures of the deal depending upon the actual label. And more over, this I do not believe is one of those over enthusiastic statements from Al. This was stratight forward answer quoting the fact how they are operating in terms of replying to FDA.
Below is the part of transcript that I am referring to.
Christopher James - Brinson Patrick Securities
Hi. Good afternoon and thanks for taking my questions and let me also add my congratulations on the tremendous progress you have made. I understand the sensitivity around not discussing – the discussions with partnerships but could you perhaps, let us know if you are able to share some of the back and forth with the FDA regarding label and Paramus discussions with potential partners during the process or is there something that will be discussed after?
Alfred Mann - Chairman of the Board, Chief Executive Officer
Actually, we do have sharing sessions in between our regulatory people and the regulatory people of those people as we believe to be say, top potential for partnerships. So yes we are trying to address that in appropriate say collaborative manner.
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Post by jpg on May 13, 2014 8:56:54 GMT -5
Go Novartis go...
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Post by seanismorris on May 13, 2014 14:44:36 GMT -5
Harsal1981,
I agree Mannkind has already found their partner for Afrezza and that partner is actively involved with the FDA on labeling discussions, etc.
There are probably one or more backup potential partners but unless something breaks down in the discussion (ie. with regards to price) it's basically a done deal. ~95%
I don't think this partner would be wasting their time in the discussions with the FDA unless it's a done deal just waiting on the FDA's approval.
When the partnership for Afrezza is announced, what I really want to hear is joint collaboration (trials) for other Technosphere drug formulations (definitely pain, and possibly asthma).
Following FDA Approval I'll probably sell 50% of my MNKD stock if there is just the partner announcement for Afrezza And, 25% of MNKD if a + collaboration is announced.
That should be taken a extremely bullish because MNKD has grown to be a huge part of my portfolio.
(If it's the 50% I'll be buying some back because I expect continued volatility in MNKD)
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Post by nemzter on May 13, 2014 15:27:36 GMT -5
PLEASE let it be someone who pays DIVIDEND$
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Post by biotec on May 13, 2014 16:37:14 GMT -5
PLEASE let it be someone who pays DIVIDEND$ I hope not on the dividends. I hope all the money is used for R@D. If I wanted a income stock Ill stick with blue chips.
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