|
|
Post by ktim on Aug 26, 2019 18:25:31 GMT -5
Skirting around $1 is never a comfortable place. I can understand the sentiment here that was expressed by someone else that breaking the dollar would be reason to sell. I may not follow suit, but I certainly don't think wanting to avoid all the process of delisting notice and talk of RS makes one mad. One can always buy back in later. Hopefully Mike is correct when he asserts that there won't be further dilution, but of course the concern over it is what is holding the price down. Unfortunately his credibility in being able to forecast is not great since he missed by a wide margin the one time he gave guidance. An inflection point would be great and indeed most of us were (some perhaps still are) predicting it to happen shortly... and then it never seems to happen. But obviously it's a possibility. But until we start seeing those NRx numbers turn upwards we're basically growing at a linear rate with the point at which Afrezza is break even a long ways in the future. So you are correct that when we do reach break even as per Mike (likely in 2021) it is undoubtedly counting on revenue other than Afrezza. Would be nice if he presented his rationale and timeline for break even. Well, what I should have said is, that if there is a likelihood of a breakeven a few years down (independent of any modeling, you seem hellbent to play raise of Afrezza numbers down to a linear trend), a share price of one dollar is at least an order of magnitude too low.. you sell if you must, I wont... Hell would be flat or when sales shrank after SNY dumped us. So let's just say purgatory bent with the linear trend. I've posted that I bought more recently, so that is far from feeling I "must" sell at this point in time. As for share price, a lot of boils down to cash flow and prospects for dilution as usual. To me being around $1 indicates Wall Street does not have faith in management's assertion of no further dilution. I think price will go up if Mike can meet the financing covenants through the end of the year (assuming market macros don't tank everything), but he's in a position of needing to prove it because it isn't obvious it's going to happen. Not meeting the covenants wouldn't be end of the world most likely, but back into a mode of negotiating with a creditor and perhaps needing to sweeten future borrowings with equity. So, as you point out it's all about assessment of "likelihood" of breakeven without further dilution. If we were to assume breakeven with no further dilution, I fully agree $1 is undervalued quite a bit. |
|
|
|
Post by lakers on Aug 30, 2019 2:43:00 GMT -5
A phosphodiesterase type 5 inhibitor (PDE5 inhibitor) is a drug used to block the degradative action of cGMP-specific phosphodiesterase type 5 (PDE5) on cyclic GMP in the smooth muscle cells lining the blood vessels supplying various tissues. These drugs dilate the corpora cavernosa of the penis, facilitating erection with sexual stimulation, and are used in the treatment of erectile dysfunction (ED). Sildenafil was the first effective oral treatment available for ED. Because PDE5 is also present in the smooth muscle of the walls of the arterioles within the lungs, sildenafil and tadalafil dilates those vessels, and are FDA-approved for the treatment of pulmonary hypertension. Sildenafil, the prototypical PDE5 inhibitor, was originally discovered during the search of a novel treatment for angina. Studies in 2002 explored its potential for increasing neurogenesis after stroke. Decision time for pipeline #17, Inhaled TS PDE5 for PAH. It has dual use. A fixed dosage can be bought over the counter if it is approved by FDA for ED and effective in 5 mins. If it is approved for PAH first, it could be prescribed off-label for ED. Conversely, if it is approved for ED over the counter first, it may be prescribed off label for PAH. Either way, I guess it’s a go by UT or Mnkd & non-UT partner due to dual indications. Could Mnkd partner with Pfizer+Mylan for PDE5 DPI for ED and women, and EpiHale package deal? In parallel, could UT move forward with PDE5 DPI for PAH? www.google.com/amp/s/www.localmemphis.com/business/pfizer-to-absorb-mylan-creating-generic-giant/amp/Pfizer’s Upjohn, which sells one-time blockbusters like Viagra and Lipitor that have lost patent protection, will be spun off and then it will combine with Mylan, a $10 billion company. The complex deal, expected to close in the middle of next year, will create a company with estimated 2020 revenue in excess of $19 billion, with sales in more than 165 countries. The name for the new company has yet to be determined. The two companies have worked together for years. Pfizer manufactures Mylan’s EpiPen, an auto-injector used to halt life-threatening allergic reactions. Mylan was heavily criticized, and its CEO Heather Bresch was brought before Congress two years ago, to answer questions about the price of the EpiPen, which had jumped five-fold to $600 for two EpiPens. They have been in short supply for more than a year because of quality problems and upgrades at a Pfizer factory. Upjohn, the name of one of the companies Pfizer gobbled up during a spate of acquisitions in the 1990s and 2000s, sells off-patent and generic drugs that include the stars that drove Pfizer’s growth: pain killers Celebrex and Lyrica, Norvasc for high blood pressure, Effexor for severe heartburn, Xanax for anxiety and Zoloft for depression. Imitrex Nasal (sumatriptan) is used to treat the following conditions: Cluster Headaches, Migraine. Fast onset is an advantage. About Cluster Headaches: A term used to describe a headache that is typified by constant, unilateral pain around the eye, with onset usually within 2-3 hours of falling asleep. Can be accompanied by a blocked nasal passage, runny nose, and-or tearing. Hard to sniff, easy to inhale. It’s feasible to find a partner for TS Sumatriptan. |
|
|
|
Post by mnholdem on Aug 30, 2019 6:06:05 GMT -5
I would approach GSK with a proposal to develop Imitrex(TS). They are in the same situation with their migraine drug as United Therapeutics is with PAH. With competition from generics and patent life issues, a rapid-acting inhaled TS-Sumatriptan would breathe new life into their portfolio.
|
|
|
|
Post by uvula on Aug 30, 2019 8:29:19 GMT -5
If Sildenafil is dual use, how do you prevent both from happening when you're just trying to help your PAH?
|
|
|
|
Post by goyocafe on Aug 30, 2019 8:39:06 GMT -5
If Sildenafil is dual use, how do you prevent both from happening when you're just trying to help your PAH? I’ve been told that if you think of the queen of England, the latter “side effect” is not an issue. 🤣 |
|
|
|
Post by peppy on Aug 30, 2019 8:40:35 GMT -5
If Sildenafil is dual use, how do you prevent both from happening when you're just trying to help your PAH? My take is people with PAH are so ill, reduced O2 levels and all, that...... |
|
|
|
Post by lakers on Aug 30, 2019 11:53:17 GMT -5
I would approach GSK with a proposal to develop Imitrex(TS). They are in the same situation with their migraine drug as United Therapeutics is with PAH. With competition from generics and patent life issues, a rapid-acting inhaled TS-Sumatriptan would breathe new life into their portfolio. Pre-clinical, Phase 1, then talk. James is a former GSK CMO. MC will update pipeline on 9/9/19 at HCW. I’d like to hear update on CF, IPF too. |
|
|
|
Post by mike0475 on Aug 30, 2019 14:28:55 GMT -5
Lakers
Are you expecting pipeline update in terms of molecule addition?
|
|
|
|
Post by peppy on Aug 30, 2019 14:32:59 GMT -5
Lakers Are you expecting pipeline update in terms of molecule addition? wouldn't that need to be a company public statement PR? |
|
|
|
Post by prcgorman2 on Aug 30, 2019 14:38:07 GMT -5
If Sildenafil is dual use, how do you prevent both from happening when you're just trying to help your PAH? My take is people with PAH are so ill, reduced O2 levels and all, that...... I'm guessing you don't prevent it? My understanding is helping with ED was just a happy accidental discovery for men taking angina medication (as long as the ED "help" didn't last more than 4 hours anyway). |
|
|
|
Post by mnholdem on Aug 30, 2019 14:38:52 GMT -5
He’s got the financing so the CEO had better put out some dates for Phase 1 trials if he wants any reaction from investors.
|
|
|
|
Post by peppy on Aug 30, 2019 14:44:49 GMT -5
My take is people with PAH are so ill, reduced O2 levels and all, that...... I'm guessing you don't prevent it? My understanding is helping with ED was just a happy accidental discovery for men taking angina medication (as long as the ED "help" didn't last more than 4 hours anyway). My take is part of regular ED is oh, oh, clogged drain. Too much fat eaten over a life time. Their arteries clogged with too much fat. *even a none fat eater will have problems by age 69. Natural inability to make and keep enough nitrogen oxide in the circulation. (Is my take.) |
|
|
|
Post by prcgorman2 on Aug 30, 2019 15:08:48 GMT -5
I suggest our culture adopt drinking red wine from an early age. I've read somewhere there is a much lower incidence of heart disease (and much higher incidence of cirrhosis of the liver) in France. :-)
|
|
|
|
Post by mytakeonit on Aug 30, 2019 15:11:07 GMT -5
|
|
|
|
Post by stevil on Aug 30, 2019 19:35:09 GMT -5
I would approach GSK with a proposal to develop Imitrex(TS). They are in the same situation with their migraine drug as United Therapeutics is with PAH. With competition from generics and patent life issues, a rapid-acting inhaled TS-Sumatriptan would breathe new life into their portfolio. I don't see a whole lot of opportunity there. The 5-HT agonists are pretty crowded. I'd prefer they go after the new CGRP class like Aimovig. Those need to be injected IM, like epipens. There is a far greater market for these, especially because they are new. I think a yearly supply runs close to $5k per patient. But insurance companies are happy to pay for it because it keeps migraine sufferers out of the ED. There is also research going on that show IV CGRP's can safely abort status migrainosus, or intractable migraines. Previously they required other neurological medications that typically took a couple days to break the headache. So there will be opportunity for a long time with these medications. The only side effect with them so far has been injection site reactions, meaning they are extremely safe and have essentially no side effects other than what's caused by the needle. Truly, this is one market I hope MC is targeting. MNKD should have a legitimate shot at landing a good partner. |
|
