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Post by Deleted on Jan 6, 2017 5:50:59 GMT -5
On deck is EpiHale IND filing, then CRL a few months later. A partner will emerge. Resuming PAHale - Great market. Starting Pediatric Study PK, URA Label change triggering international expansion to Canada Plenty of catalysts. No wonder Matt was confident Pps would be above $1 thereby avoiding delisting. With the above, I would like to know how much cash would be put into Mannkind's bank account. Rhetorical but I would imagine that $20 - $30mm would not move SP much. When Matt P announced the money from Sanofi along with the ability to sell the Valencia facility, the stock I believe popped to around 0.78 / share. Set aside Afrezza sales for a moment, how much cash from what you are discussing Lakers would be needed to drive SP > $1.00. Is a $50mm injection enough to do it, $75mm?? anyone with a crystal ball? Now if we get $50mm and we start to see growth in Afrezza sales along with cash, the equation changes quickly but this means Afrezza NRx needs to show growth now. Going to be an interesting Q1. |
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Post by tarheelblue004 on Jan 6, 2017 8:41:31 GMT -5
I agree @scotta. It's great that these things are happening, but even if all of these happened over the next three months, I don't see the SP going over $1. In my mind, the short position is based upon the cash situation. None of these except for the potential of a EpiHale partnership extend the runway prior to the delisting date...Ped study, in fact, would be expensive. I am also less convinced than others that a partner for EpiHale is a certainty, I remember Matt saying they may go-it alone since they're building out a commercial team. I don't believe these are the only near-term catalysts - I think there will be another deal involving cash receipt, or they are confident that their 2017 Go to Market strategy for Afrezza will drive great script growth which in turn will raise the SP. Perhaps EpiHale partnership is the cash receipt deal, but I really think there's something else. If nothing else, just one more wrong prediction I've made on this stock  |
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Post by mnholdem on Jan 6, 2017 8:52:08 GMT -5
*** WARNING: OFF-TOPIC***
Who came up with this "EpiHale" label? Wouldn't "Epinhale" make more sense?
*** Okay, back to our normally scheduled program. ***
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Post by tarheelblue004 on Jan 6, 2017 10:03:06 GMT -5
I really like EpicHale |
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Post by rossomalley on Jan 6, 2017 20:43:21 GMT -5
Given the current 'State of MNKD', I'm going with "EffinHale".
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Post by lakers on Jan 12, 2017 18:14:38 GMT -5
International Expansion
Filing being prepared for Brazil, Canada, Mexico, Australia, MENA, UAE
Evaluating EMA (for EU) and othe regions
MENA: Middle East and North Africa region
UAE: United Arab Emirates, English and Indian dialects are widely spoken and is the language of business and education, especially in Abu Dhabi and Dubai.
Brazil is the fifth most populated country in the world. 2016 – 210,429,129 people.
The majority of Brazilians live within 300 kilometers of the coast, while the interior in the Amazon Basin is almost empty.
This coincides with Outsulin trademark registered in Canada, Mexico, Australia recently.
Expect multiple internationally regional partners with upfront money and royalty streams as Nates predicted. MENA should include Israel.
This might obviate the need for R/S to get pps above $1.
The Danbury plant might finally be at 100% utilization thereby lowering mfgr cost per unit. It can open 3 more lines if needed to satisfy worldwide demand.
We have nowhere to go but up, folks!
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Post by lakers on Jan 12, 2017 19:58:34 GMT -5
Progressing pipeline forward with a focus on strategic partnerships [upfront money plus royalty]. As I often said Mnkd wouldn't go alone. Is it clear enough now?
Initial clinical eval criteria
Aero performance
Ambient temp stability
EpiHale: 2 formulations have been eval'ed
Both met performance. PK profiling underway
Successful meeting w/ FDA in Dec 2016
PAHale: Tresprostinil, 6 formulations have been eval'ed
4 met performance, moving to PK profiling
Additional formulation dev on all 4 continuing in 2Q17
CINV: Palonosetron, 2 formulations have been eval'ed
Both showed aceptable aero, will require additional work to improve Ambient temp stability
Eval opps for complementary product [cross-sale, co-market a 36-hr basal as Tresiba by Novo, perhaps?]
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Post by Deleted on Jan 12, 2017 20:20:33 GMT -5
Eval opps for complementary product [ cross-sale, co-market a 36-hr basal as Tresiba by Novo, perhaps?] yeah if Novo was a small dog in pharma too.. But they are not. Novo has better footprint than MNKD. May be if another BP other than Novo, Lilly, SNY comes up with lantus Biosimilar.. then it would be a strategic good move... but that Lantus biosimilar will most likely require less marketing, so the cross sale wouldnt be of a big advantage to that partner. |
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Post by mnholdem on Jan 12, 2017 20:57:04 GMT -5
Frankly, I wouldn't be surprised if MannKind will take its Epinephrine(TS) to market if potential collaborators try to low-ball the company. Matt Pfeffer may have eluded to this in early 2016, when Dr. Urbanski commented that anaphylactic shock does not lend itself to the kind of testing typically required in Phase 3 trials with other types of drugs. The Phase 3 trial requirements (and associated costs) for Epinephrine(TS) will be extremely low, since FDA will rely upon data from the Phase 2 trials. Both the API and the delivery system (Technosphere) have already been FDA approved and prescribed in the market so the FDA will prefer not to take the risks of inducing anaphylactic shock in trial patients to prove the efficacy of the API. Also, Epinephrine has been successfully administered via pulmonary delivery with other FDA-approved brands.
With a full-time sales force already out there selling Afrezza (successfully, I hope by the time the FDA approves this API) there would be no initial expense of commercializing to the degree MannKind had to with Afrezza, such as setting up commercial management and a sales force. The Area Business Managers (aka Sales Reps) will simply have another drug to introduce to their existing accounts. I'm confident that by then those accounts will include many general practitioners and HCPs in addition to the endocrinologists.
I hope that a partner will step up with a good offer. I'm sure that all shareholders would want that. However, my point is that it will not be the end of the world for MannKind if they keep all the profits by bringing Epinephrine(TS) to market on their own. It's my hope that, by then, they will be generating sufficient revenue from Afrezza to fund their 2nd entry into the market.
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Post by lakers on Jan 13, 2017 0:28:24 GMT -5
On the contrary, EpiHale partnership will fund Afrezza 3.0 and PAHale while waiting for Afrezza approval in foreign countries. Remember, Afrezza biz will unlikely be profitable for another year unless regional partners come up with $100M each in 4Q17 as approval and signing partners take time. Potentially, Canada partnership will happen first (the same with Exubera), followed by Australia, Mexico, Brazil, UAE, Saudi Arabia. Israel will happen in 2018 as we already missed the cycle explained in my last year post. RLS is a wild card. If their drugs are approved by 4Q17, 2018 will be an interesting year for Mnkd. EU will be a mid 2018 story after ped, initiation/titration trials finish. IMHO, PAHale will be much bigger than EpiHale if you read my article last year as TAM is much larger. It is 3Q17 or 4Q17 story if we partner. mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450mWe have to sacrifice EpiHale for the survival of the company without R/S. |
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Post by surplusvalue on Jan 13, 2017 0:59:10 GMT -5
On the contrary, EpiHale partnership will fund Afrezza 3.0 and PAHale while waiting for Afrezza approval in foreign countries. Remember, Afrezza biz will unlikely be profitable for another year unless regional partners come up with $100M each in 4Q17 as approval and signing partners take time. Potentially, Canada partnership will happen first (the same with Exubera), followed by Australia, Mexico, Brazil, UAE, Saudi Arabia. Israel will happen in 2018 as we already missed the cycle explained in my last year post. RLS is a wild card. If their drugs are approved by 4Q17, 2018 will be an interesting year for Mnkd. EU will be a mid 2018 story after ped, initiation/titration trials finish. IMHO, PAHale will be much bigger than EpiHale if you read my article last year as TAM is much larger. It is 3Q17 or 4Q17 story if we partner. mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450mWe have to sacrifice EpiHale for the survival of the company without R/S.
That would mean that Epihale partnership etc would have to arrive before delisting. I dont think that's realistic at all given the time frame. I agree it would be a much better sacrifice since the alternative would be a human sacrifice with a RS...and that would be us. Unfortunately I think we should be prepared to suffer despite your continuous optimism. "I see a bad moon a rising. I see trouble on the way." |
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Post by lakers on Jan 31, 2017 19:04:04 GMT -5
Matt will update on pipelines on 2/1/17 since Ray won't be there.
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Post by Deleted on Jan 31, 2017 19:31:45 GMT -5
Matt will update on pipelines on 2/1/17 since Ray won't be there. A partnership ship deal as many expect will have the partners in the call? So would be awkward to toot 1's own pipeline or is it something else? |
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Post by falconquest on Jan 31, 2017 20:07:47 GMT -5
Good luck to everyone tomorrow but I must say, I'm with surplusvalue here. Matt could have all kinds of cool things underway but if they don't have cash nearly everything is moot. We either get over a buck based on news tomorrow or we suffer through a reverse split. That will create a buy opportunity at some point. I don't like to make predictions and I hope I'm wrong but I see a potential for buying shares in the high 20 to low 30 cent range (hope I'm wrong).
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Post by mango on Jan 31, 2017 20:20:39 GMT -5
Probably a better explanation of what to expect near-term with sales now that they are all MannKind employees. I wouldn't be suprised if an update on the Pediatric clinical trials were announced (start date or similar info). Matt said in the JPM Healthcare Conference (also in the slides I think) that the Pediatric clinical trials would be something to expect early Q1. Also, an update on the Technosphere-Epinephrine program wouldn't be an unrealistic thought either. Possibly an update on RLS since Andrea Leone-Bay was originally scheduled to speak at a conference (which I hold suspect, considering how unprofessional it is to bail and not even have another person from the company speak in her place). We shall see.
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