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Post by mnholdem on Nov 6, 2019 20:00:58 GMT -5
I think the word Castagna used was something like "tweaking" rather than re-training but I think you're right, slug. That's exactly how Wall Street would interpret it. Take out the Brazil shipment and Q3 revenue was lower than the previous quarter.
That suggests more than simple tweaking is needed.
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Post by mnholdem on Nov 6, 2019 19:55:54 GMT -5
So are you going to label whoever is in charge of the tadafill clinical studies "DickHead"? Sorry, but I luv double-entendres and I couldn't resist!  On a much more serious note, tadafill is prescribed for high blood pressure in the lungs (pulmonary arterial hypertension). Why are you jumping to a conclusion that this pipeline API is being developed for erectile dysfunction? I seriously doubt that's the plan. The reference to ED is actually right on the slide. See above. Wow. Mann always said that would be way too dangerous because of the drop of blood pressure. Maybe he was thinking of a different API? |
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Post by mnholdem on Nov 6, 2019 19:33:06 GMT -5
Aren't you people expecting this scenario? This is normal ... expect 6 cents loss ... do better and only get a 5 cent loss ... so yes, I expected it. And yes ... "Hey Martha ... it's another buying opportunity !" Too bad that I feel that I have enough shares ... well more so that I found out that my cash influx won't be here till mid month. CRAP !!! BTW, I believe I heard Mike C say that the next earnings call will be at the end of the 1st quarter. We'll probably get a year end financial report though. Anyway, the year end party will probably be in Brazil with a lot of dancers !!! But, that's mytakeonit (Did I hear Mike C giggle when he said that the container to Brazil cleared out all of the older stock of Afrezza? I also love the India projections !!!) There were reports in Brazil which indicated relaxing the refrigerated storage. Perhaps the Brazilian regulators also extended the shelf life? Regardless, Afrezza would have indigenous packaging printed in Portuguese so MannKind simply cannot be shipping old stock packaged for the USA. Some drug companies send soon-to-expire inventory to 3rd World countries via agencies like The Gates Foundation but MannKind hasn't managed to get Afrezza approved in any of those countries so expired stock gets incinerated. |
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Post by mnholdem on Nov 6, 2019 19:05:34 GMT -5
I’m tired of rest and grow. Agedhippie posted in another thread that if you subtract the $0.7 million revenue from Biomm, Afrezza 3Q revenue was less than 2Q. So the CEO was halfway successful. |
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Post by mnholdem on Nov 6, 2019 18:52:40 GMT -5
So are you going to label whoever is in charge of the tadafill clinical studies "DickHead"? Sorry, but I luv double-entendres and I couldn't resist! On a much more serious note, tadafill is prescribed for high blood pressure in the lungs (pulmonary arterial hypertension). Why are you jumping to a conclusion that this pipeline API is being developed for erectile dysfunction? I seriously doubt that's the plan. |
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Post by mnholdem on Nov 6, 2019 9:53:53 GMT -5
If I'm not mistaken, we should learn how much revenue was accounted for the Brazil shipment, but CEO Castagna may bury that detail under "revenue" and not provide details. It may depend upon whether he views it as confidential (for strategic purpose) or as a feather in his hat. Unfortunately, since the Brazilian Government has yet to have release the pricing they've set for Afrezza, it will be virtually impossible to determine the number of SKUs shipped for Biomm's initial order. I'm more interested in the revenue generated from Biomm. We'll just have to wait and see how forthcoming Mr. Castagna or Mr. Binder are in this regard. Having listened in on this morning's earning call, I appreciate that management did, in fact, break out the revenue for the Brazil shipment. $0.7 million is the revenue figure cited and CEO Castagna elaborated on two items: - The shipment has cleared customs and is now warehoused (good);
- Biomm is still negotiating with Brazilian authorities over Afrezza pricing (not so good)
The Brazilian pricing model is taking so long that I suspect that Biomm has needed to produce additional clinical evidence to support a higher price for Afrezza than other available insulin. That's entirely my speculation, but it's not so far-fetched to think that MannKind/Biomm need the price point to generate sufficient profitability to support Biomm's sales activity going forward.
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Post by mnholdem on Nov 5, 2019 20:19:14 GMT -5
Well said mnholdem , et al. The product and I'd add the opportunity given the current-state of competing therapeutics. I'm reminded of Dr. Kendall's tirade couple of years ago at the ASM. That was rich given where we still remain, but it's still a classic in my mind and of course still true to a degree. At least one executive at MannKind has a set of balls. I admire the way Amarin took on the FDA in court and won based upon the scientific data. Kendall expressed disbelief over the FDA's interpretation of clinical data. Like "this seems too good to be true so we'll add a few minutes to the onset of action". Kendall spoke out. The CEO, on the other hand, folded to the FDA and removed the pizza from the Afrezza TV commercial. Because the FDA thought it sends the wrong message about diabetes? What about the message behind Afrezza that it can help control your blood sugar, even if you're eating pizza. Positioning Afrezza as a new insulin that adapts to your lifestyle (unexpected moments) would resonate with diabetes patients if this CEO would just show up. Give Kendall the CEO job and you'll see some major movement. He's one of the industries leading experts for crying out loud! |
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Post by mnholdem on Nov 5, 2019 17:45:37 GMT -5
How many 5-10 year longs have posted that belief? Hundreds of them, just on ProBoards alone, have seen their invest erode to a pittance. Perhaps the latecomers are a bit insensitive to this sad fact.
But...keep on pumping. I do believe the science will prevail - much faster in the right hands - and Afrezza will become a major player. How long? That depends entirely upon management and their competence at eliminating the so-called roadblocks.
It's the product that keeps me in the game.
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Post by mnholdem on Nov 5, 2019 17:35:24 GMT -5
What I wonder is whether a more accurate assessment of the market for Afrezza by the CEO and CFO would have resulted in an operating profit, as was claimed MannKind for 4Q18, if I recall correctly. Scripts are increasing with no additional DTC expenditure...are operating losses growing?
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Post by mnholdem on Nov 5, 2019 17:26:15 GMT -5
One question I would want answered is what percentage of MannKind's inventory has had to be disposed so far in 2019. I recall the CEO made some fairly aggressive revenue forecasts in 2018 and early 2019 (he's since become mute on that front). If the company manufactured Afrezza to Castagna's projection (based upon the new sales model he touted), then it would seem quite likely that Danbury over-produced and has a bloated inventory. Since Afrezza has a limited shelf life, the company would have to dispose of expired inventory. This could have the effect of increasing COGS since your manufacturing cost (you cannot deduct the cost simply because you scrap product) must be divided into less units on the shelf, and your cost per unit skyrockets. I very much doubt that this CEO would divulge what percentage of the past two years inventory had to be discarded but I would really like to know. Script growth is growing (some might label it anemic) but the pace indicates that the new sales strategy is not what was hoped for. Has this resulted in unavoidable excesses in operating expenses? I need to go back and check the 2018 EOY financials for operating expenses/losses. Unfortunately, I'm not a major( +10% ) shareholder so I likely wouldn't be given access to drill down into the financials. A lot of details can be hidden in an income statement.  |
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Post by mnholdem on Nov 5, 2019 16:52:42 GMT -5
If I'm not mistaken, we should learn how much revenue was accounted for the Brazil shipment, but CEO Castagna may bury that detail under "revenue" and not provide details. It may depend upon whether he views it as confidential (for strategic purpose) or as a feather in his hat.
Unfortunately, since the Brazilian Government has yet to have release the pricing they've set for Afrezza, it will be virtually impossible to determine the number of SKUs shipped for Biomm's initial order.
I'm more interested in the revenue generated from Biomm. We'll just have to wait and see how forthcoming Mr. Castagna or Mr. Binder are in this regard.
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Post by mnholdem on Nov 5, 2019 12:28:10 GMT -5
As I understand it, the MidCap covenants pertain solely to Afrezza sales revenue. UTCH sales of TreT or Tyvaso(TS) are a separate issue and are a couple years away regardless. Even the $12.5M milestone payment may not be applied against the covenant.
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Post by mnholdem on Nov 2, 2019 16:52:05 GMT -5
There are lots of technical day/swing traders who only take a cursory look at the company behind the ticker. With 4 Buy ratings and upwards movement MNKD may start generating some volume in the near-term.
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Post by mnholdem on Nov 2, 2019 6:08:53 GMT -5
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene® MIST (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene® MIST is the only FDA-approved asthma inhaler available without a prescription in the United States. Primatene® MIST is indicated for the temporary relief of mild symptoms of intermittent asthma in people ages 12 and above.
Amphastar’s CEO, Dr. Jack Zhang, stated: “We are very happy to have received FDA approval for Primatene® MIST and are proud to bring this important product back to the over-the-counter (OTC) market in the United States."
The newly approved, patented formulation of Primatene® MIST is made with the same active ingredient, epinephrine, which was used in the original Primatene® Mist before it was removed from the market in 2011 for environmental reasons pursuant to the Montreal Protocol, an important international environmental treaty, which phased out products worldwide containing ozone-depleting CFCs. The product’s new inhalation delivery system no longer includes CFC as the propellant and has other significant new features, including a built-in spray indicator and a metal canister, which replaces the glass container used in the original Primatene® Mist product.
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Amphastar is the company that supplies the insulin used in Afrezza Insulin (Human) Inhalation Powder.
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Post by mnholdem on Nov 1, 2019 7:55:16 GMT -5
Holdem, are you saying that Mannkind used a different stereochemical configuration of treprostinil from that of treperostinil in Tyvaso? .... or something else? Different suppliers. Not all API (Active Pharmaceutic Ingredients) are created alike, even if they have the same name or chemical makeup. India, for example, has been encountering problems with the FDA in regards to generics being manufactured there. I should have been a bit more clear about what I meant.  |
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