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Post by LosingMyBullishness on Mar 13, 2017 21:38:51 GMT -5
Matt spent a lot of time talking about the new salesforce and how they are of a different caliber (experience/relationships/incentives). I'd like to believe they are seeing some good traction otherwise i don't think he would have made these statements - specifically how he expects improvements in script #'s soon. Also keep in mind Mannkind is currently in a quiet period until the earnings are released. On Thursday's call we will hear much more when it comes to actual news and updates. Hmm, if they had something to offer, they would have said so irrespective of coming earnings. The only thing they can offer to us right now is hope that the new sales team does a better job than the SNY team at its best times and the hired guys (who Mike&Matt was initially very enthusiastic about back then). And the delay in the commercial doesn't help to boost credibility. Would have loved to see a cool commercial. That would have been a message to the market. But instead they showed their standard slides.. boo.
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Post by lb on Mar 13, 2017 21:42:47 GMT -5
I think it was a solid presentation. New pediatric trials will start in April. Label change/PDUFA in September. New flex pack launches and new sample packaging. International filings will start shortly. DTC commercials in 1H 2017.
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Post by MnkdWASmyRtrmntPlan on Mar 13, 2017 21:45:12 GMT -5
So, how about some forecasts for tomorrow's SP I'll start the bidding ... Do I hear $2.25 shortly after opening? A $2.50 close? I'll check back in the morning, but I'm shutting down for the night.
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Post by brotherm1 on Mar 13, 2017 21:55:24 GMT -5
Thanks for your report MIMRP. Very nice
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Post by mytakeonit on Mar 13, 2017 22:16:35 GMT -5
$2.25 ... $2.50 Heck, I'm not releasing any shares till it reaches $100. And even then, I'll only sell 500 shares or so. This is so funny ... we all know that the conference is to inform people about Afrezza that hardly even heard about it. And yet, we sit and watch to see if major news will be coming out. Even the quarterly will be similar since script friday will be 2 days later. But ... ahhh ... "Believe me" ... our day will be here soon. (Ooooh ... I didn't say that.) This is like my wife telling me ... "Why do you keep watching that Jason Bourne series ... It's not going to change." I reply ... "I'm going to keep watching till they kill that short guy!" (I added a word ... can you guess which one?)
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Post by Cowgirl on Mar 13, 2017 22:37:19 GMT -5
Dream on about the share price. Matt's got a lot of experience hanging out hope - trials, international deals, script builds etc. - but that's no match for cash burn and such low script numbers that even if they grow a bit would still be considered pathetically low given how revolutionary the drug/inhaler were supposed to be. (Wasn't it just last November when there was a post about "Greatest Conference Call Ever?" (Price was around $80 cents - now we are sub .40 cents (pre-split))
Why filing for international now - why not 2 years ago? And the "we need to get Afrezza to sell here before we can negotiate good international deals" stuff. Great idea but where does the cash come from between here and there? Al's money is gone! There's no more piggy bank to allow for the arrogance of management (incl. Al Mann) had for the last decade. And they've totally left themselves with no out/little options at this point for appropriate funding.
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Post by saxcmann on Mar 13, 2017 23:15:01 GMT -5
I thought most telling comment from Matt saying he expected scripts to go up in next few weeks. Gonna get ugly if they don't?... MNKD has passed ugly. Ok...more ugly
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Post by mnkdfann on Mar 13, 2017 23:16:58 GMT -5
We'll get into the financials on Thursday. The good news is we did a lot to solidify our financial position and give us cash that will take us comfortably into the second half of the year. We demonstrated we could do this. And these are some of the things we did in our negotiations with Sanofi to relieve the debt? and get some cash, and also to change some of our supply arrangements. I thought everything Sanofi settlement related was done and reported some months ago. Are they just promising to rehash old news here?
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Post by mnkdfann on Mar 13, 2017 23:19:46 GMT -5
Why filing for international now - why not 2 years ago? This was addressed previously by Mannkind in an investor's conference last year and in an old FAQ on its website. Going international wasn't part of Sanofi's initial strategy. Then it took a year for Mannkind to get the rights to go international back from Sanofi after Sanofi quit. So it was only in late 2016 / early 2017 that Mannkind could even start to do anything meaningful on the international front.
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Post by babaoriley on Mar 14, 2017 1:24:14 GMT -5
Our boys had a lot of breaks go against them - the Marty S. letter to the FDA was yuge! And then the SNY CEO who liked us gets canned and the new guy doesn't seem to like us at all. Those were big, big events, and they went the wrong way. Just like the rest of life, difficult to predict and surprises can be either good or bad.
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Post by surplusvalue on Mar 14, 2017 1:45:26 GMT -5
As I said unless they had something substantial to announce to support the RS this would be underwhelming. Just more fluff and "we are working on all these things". Again.
Of course the new sales force is larger because they led us to believe the sales force for 2.0 was larger than it was and then admitted that it was almost half. So this is supposed to be a positive announcement and a revelation? Please., they must really think we are stupid.
And notice the carrot. They are working on expanding international. Where have we heard that before? Then they say we should look for this (when exactly ...nothing) They will probably announce it as it happens. And then the stick to beat it back... "you know these things take time". Nice rollback.
And scripts ? We expect (of course we could be wrong ) for them to increase but not right away. (starts off with couple of weeks which then turns into a month or two or ?)
And still no substantial DTC (were in the middle of it...we are working on it etc etc etc.)
Great closer too. We are committed, confident .....
Inspirational.
Ask me why I'm not surprised. (I dont have a pair of those cool colourful glasses but I bet MNKD would be able to sell those for sure)
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Post by lakers on Mar 14, 2017 2:15:53 GMT -5
Matt Pfeffer Okay. We are going progress the pipeline. We’ve had to start some of these programs quite a lot because we just enough to cash to do it. We need to be successful before we go too far. But our Epi program has gotten a lot of press given the controversy around epinephrine but we do have an inhaled Epi program that’s not in the clinic yet, but we’ve shown feasibility and formulation and so forth and it’s ready to move there. We did meet with the FDA and map out a clinical strategy, so I think that’s ready to go. We also have programs in Treprostinil and Palonosetron and I could spend a lot of time talking about those. We think they are attracting targets because of the way the regulatory pathway works for those. These are essentially generics at this point. We can reformulate them into an inhaled formulation and give them some vantages. So for example for Treprostinil, this is typically done with a nebulizer today. It’s a very long involved treatment and the treatment doesn’t last terribly long. So introducing something you could do with obviously just a few seconds with Afrezza, we think we have some interesting advantages. At the same time Palonosetron typically only given in the doctor’s office. This is injection today. If we could give a home version by inhalation it has some nice advantages in the chemo-induced nausea and vomiting setting. And we continue to just look at other areas as well. And recently we showed this data. This is from an orally inhaled hormone, interesting way to get into your system and does exactly as we typically see, which is its rapid peak, since we call a pulsatile delivery which is important in these kind of settings, and then it goes away relatively quickly. So this is exactly what you want to see for a drug like this. That said, we need to get Afrezza be more successful before we can spend too much time and might be working on them. MannKind's (MNKD) CEO Matt Pfeffer Presents At 29th Annual ROTH Conference (Transcript) $MNKD www.seekingalpha.com/article/4054768So having the ability to stay within a range is a nice predictor of a long-term outcome. With Afrezza we find it’s much easier to do that but we don’t have a trial to show it yet. Al Mann, before he left us, always talked about wanted to do this trial. We’re finally going to do it. That should start probably next quarter. At the same time we have other studies that will demonstrate how you can use this more easily, especially in the type-2 setting and so forth. And these are all - I’ll call them, label enhancement studies. We have some clinical work - fair amount of clinical work we’re planning in the near term. In addition it’s required that we would do it anyway. We have pediatric study started. Now we had hoped to start that sometime late this month. I think it’s going to fall probably into the following month because at the same time we’re finding ways to speed up the whole process. The original trial designs we inherited from our former partner, Sanofi, were very nice but they would have probably gotten this approval somewhere in the 2020 timeframe and we would like it to happen much more quickly than that. So we’ve done a lot to redesign those studies. So that should happen relatively quickly. We think this is a great product for kids. I get a lot of inquiries from parents all the time. I have young children myself. I knew they needed insulin, I’d certainly want to have this available to them. So this is only currently approved for adults, so we’d like to expand that indication into pediatric use. we’ve really, really done fabulously well getting coverage from the third-party reimbursement insurance companies. So I’m happy to say that today 70% of covered lives either are on formulary either with no prior authorization requirement or what we call light prior authorization, which usually just means you follow the label. It doesn’t mean you have to try everything else and fail with those, so the things we used to have to deal with. [Step Therapy] And we are going to be going into some international expansion, so watch for that. We’ll probably announce those as it happens, that at least aren’t typically quick but I think a scenario right for growth because frankly we need to get sales volumes up to improve our margin on this product, so we wanted to expand it in the U.S. but expand in oversees is a right market for us as well, particularly in some jurisdictions where avoiding injection as a major marketing advantage but we have - we know that there are lot of areas that people are just not very well controlled and we think this to be a nice product to introduce and which of some of those - some of them are listed here. [Matt revealed them here]. I know that [indiscernible] that’s just so poorly controlled and it’s hard to get people to do their injections as they should in that region. We’re already evaluating other areas as well but pricing is always going to be an issue, so we’ll hit them one at a time as we can do it.
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Post by akemp3000 on Mar 14, 2017 5:11:44 GMT -5
The transcript seemed to be from an international language interpreter but the following key points seemed most important: 1. Direct sales force almost doubles the size of the contract sales force with more experienced reps that have relationships and better incentives. 2. Matt expects scripts to begin rising in the next couple of weeks. 3. International announcements are coming soon and will be announced as they occur. 4. Pediatric study by Sanofi had to be reworked to get results sooner than 2020. 5. TV commercials are coming in Q2 6. Sponsorship of diabetes reality show is coming this summer. 7. Label improvement is expected in September.
There were some negative points but the best takeaway is that scripts are expected to rise in the next few weeks. IF this happens, and is followed by international announcements, we should FINALLY be on our way up for the long haul.
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Post by lennymnkd on Mar 14, 2017 6:01:23 GMT -5
Not to mention CGM ! I think they have something up there sleeve with that .
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Post by n8 on Mar 14, 2017 7:47:34 GMT -5
CGM?
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