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Post by sophie on May 10, 2017 18:17:37 GMT -5
If Novo is also producing an Ultra rapid insulin and they too get that designation, it could make the label change insignificant. As we're seeing now, being in the same class as RAA's is doing nothing for us because there are other options that docs like better with no reason to choose Afrezza over them. A saving grace would be if this other ultra rapid insulin behaves similarly and paves the way for an understanding of how Afrezza works, but even then, until a long term safety test is completed, I see little reason for a label change to improve sales if we're not the only drug in that class. Actually I think it potentially could be good to have a company with huge marketing budget trying to sell the concept of needing a faster insulin. That might get doctors thinking about switching patients from the traditional three subq insulins to the new "ultra rapid" class. If it's just MNKD that is "ultra rapid" it may still get ignored by doctors. Your bolded phrase was basically the intent of my red phrase. As for the rest, I suppose we'll see. Contrary to what many believe on here, I really want Afrezza to succeed. Maybe Matt can make that happen, but I no longer trust in the company's ability to do it. I'm at the point now where I'll have to see it before I believe it.
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Post by nadathing on May 10, 2017 18:21:00 GMT -5
I respectfully disagree. The PK/PD data from EMA shows that Fiasp is twice as fast as Novolog, but that still WAY slower than Afrezza. My point was that, as of yet, it doesn't appear physicians care too much about the speed of Afrezza (they've known PK profile for a couple years). If they did, they would be prescribing it right now. As it stands, Afrezza is about 4 times faster than other RAAs. Why would separating Afrezza into another category with an insulin it is only twice as fast as make the situation better? Change the label to show lower A1c and decreased peripheral neuropathy to peers to really hit the jackpot. If the label change allows for more coverage, I would be more inclined to agree with you. However, it's my opinion that coverage isn't the greatest roadblock. If coverage is the greatest impediment, script counts should be increasing with increasing coverage. They're not. From the handful of physicians I've talked to, safety appears to be the biggest hurdle. Diabetes is such a slow killer that I don't think physicians are willing to increase short term risk for long term benefit. They still see Afrezza as a potential health risk. Nothing that hasn't been shared on here before. There is little doubt in my mind that if exogenous insulin is still needed in 5-10 years to treat diabetes and Afrezza has been deemed safe by clinical data, it will be the drug of choice for insulin dependent diabetics. I think it will be the insulin of choice for juvenile diabetes. I think kids will figure out dosing faster than adults. I'm a T2. Most of us are controlling our disease with diet, exercise and oral meds. GLP's do a great job at reducing A1c's. Why would a doctor prescribe Afrezza to a patient who is managing their disease already? The concern is, when will Afrezza be approved for children? Does MNKD have the money to even start and finish the trials?
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Post by babaoriley on May 10, 2017 18:21:42 GMT -5
What exactly does "we are on file in a Middle Eastern country" even mean?? If mnkd actually makes a large international sale soon, then I believe mnkd will survive and thrive. I have no doubt about the superiority of Afrezza, Just need to extend the runway somehow. That being "on file" thing is interesting, isn't it? Not sure if it isn't similar to be "wanted" in the states. I'm not sure, but I get the feeling that for now, they are just selling the Dreamboat to some Arab country(ies). Perhaps the Arabs will insert some compressed air into a cartridge for use during a haboob. Insulin sales will hopefully follow. But I'm not looped in like others are here, so it's just a guess.
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Post by tingtongtung on May 10, 2017 18:24:59 GMT -5
All depends on your expectations, nada. I wasn't expecting much more than nada, unless they were going to announce the "deal." I guess they haven't quite wrapped it up, so no announcement. Hopefully, soon we can hear about whatever exactly it is, but it got some shorts scrambling, that's for sure. I was expecting solid details on Epi and Juvenile study. I was expecting to hear how they would fund ongoing operations into 2018. I understand they can't release any information on pending deals, but this was just more of the same song and dance we've heard for years. This company and management has exhausted me. I'm still going to hold until it is sold, becomes profitable or the doors close. I never leave a slot machine with a dollar in my pocket. Right... Epi is getting less interesting everyday. Just yesterday saw a report on pbs that the expired 4 year old Epi injections are still good. Even though Afrezza is so good, it is struggling. I think Epi will be a pocket change even for MNKD. Other use cases may be better. But, Afrezza is the MVP in my opinion. They have to get good financing done to extend the runway ASAP. They have to educate patients, get the juvenile studies done, and target that category as well. If they apply the same kind of commitment, I'm sure they can do it. But will be a few years. Team (Matt, Mike, Ray, others) looks good. Hopefully they do it right. They screwed up big time by not raising cash earlier..
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Post by sweedee79 on May 10, 2017 18:29:15 GMT -5
The run up sounds like it was because of the "middle east" comment. Someone expected the deal to be done and announced on this call. Not sure what this run up was about... but as soon as the pps got up around .80 , and 5 minutes before close there was high volume selling, price fell fast and into AH before the CC .... and there will be lots of selling tomorrow... there didn't even have to be news... or any rumor to pump the stock... the price action alone did that...
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naykitop
Newbie
Posts: 14
Sentiment: Long
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Post by naykitop on May 10, 2017 18:30:34 GMT -5
What exactly does "we are on file in a Middle Eastern country" even mean?? If mnkd actually makes a large international sale soon, then I believe mnkd will survive and thrive. I have no doubt about the superiority of Afrezza, Just need to extend the runway somehow. That being "on file" thing is interesting, isn't it? Not sure if it isn't similar to be "wanted" in the states. I'm not sure, but I get the feeling that for now, they are just selling the Dreamboat to some Arab country(ies). Perhaps the Arabs will insert some compressed air into a cartridge for use during a haboob. Insulin sales will hopefully follow. But I'm not looped in like others are here, so it's just a guess. Being on file, as in their regulatory docs have been filed. Guys this ain't rocket science. Don't overthink a simple word.
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Post by babaoriley on May 10, 2017 18:33:55 GMT -5
That being "on file" thing is interesting, isn't it? Not sure if it isn't similar to be "wanted" in the states. I'm not sure, but I get the feeling that for now, they are just selling the Dreamboat to some Arab country(ies). Perhaps the Arabs will insert some compressed air into a cartridge for use during a haboob. Insulin sales will hopefully follow. But I'm not looped in like others are here, so it's just a guess. Being on file, as in their regulatory docs have been filed. Guys this ain't rocket science. Don't overthink a simple word. Thanks for that clarification, naykitop, I get pretty confused sometimes, that's why I appreciate MNholdem watching over me carefully! Thanks, MN!
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Post by peppy on May 10, 2017 18:35:17 GMT -5
That being "on file" thing is interesting, isn't it? Not sure if it isn't similar to be "wanted" in the states. I'm not sure, but I get the feeling that for now, they are just selling the Dreamboat to some Arab country(ies). Perhaps the Arabs will insert some compressed air into a cartridge for use during a haboob. Insulin sales will hopefully follow. But I'm not looped in like others are here, so it's just a guess. Being on file, as in their regulatory docs have been filed. Guys this ain't rocket science. Don't overthink a simple word.Sold! "Matt's exact words in the CC: "I can announce today that we are actually on file in one Middle East country and are in later stage negotiations in a number of jurisdictions."
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Post by mnholdem on May 10, 2017 18:42:23 GMT -5
I respectfully disagree. The PK/PD data from EMA shows that Fiasp is twice as fast as Novolog, but that still WAY slower than Afrezza. You don't really mean "respectfully" do you? Actually, I meant what I said to sophie. At the first news of a new Ultra-Rapid-Acting insulin in Europe, I decided to learn about Fiasp. "Second-in-Class" simply doesn't carry the weight of "First-in-Class". I wanted to see if Novo Nordisk would beat MannKind to the punch in the USA. They won't, but when Fiasp becomes FDA approved they'll have a massive sales force and cash to market Fiasp here. MannKind needs to make some inroads with Afrezza before Fiasp gets here, IMO.
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Post by sportsrancho on May 10, 2017 18:47:09 GMT -5
Being on file, as in their regulatory docs have been filed. Guys this ain't rocket science. Don't overthink a simple word. Sold! "Matt's exact words in the CC: "I can announce today that we are actually on file in one Middle East country and are in later stage negotiations in a number of jurisdictions."
He rushed that a little. They know it's leaking IMO.
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Post by falconquest on May 10, 2017 19:01:51 GMT -5
Transcript from Matt's most important items: We're becoming more efficient and improving our financial position on a daily basis. Decreased our cash burn rate from 10M/Month to 7.4 M/month. Continuing to talk with Deerfield about restructuring some of those debt instruments. Lease expired in April and they signed a new lease on a less expensive corporate and commercial HQ facility in West Lake Villiage, CA, which is closer to the bio-pharma talent pool. Improving in international area. We are on file in one middle-eastern country. And in later-stage negotiations in a number of other different jurisdictions. You'll see announcements on that in the near term. Clearly, our cash position is better than it has been in most quarters in the past. We don't have everything we could possibly want. The cash we have today should take us comfortably into third quarter, but we estimate to get into the end of year will probably take us another 20 to 30 million beyond that. That said, I have no doubts and I am quite confident that we will have no difficulty raising that kind of money to get us to where we need to be. We've primarily been focusing on debt instruments recently because we have not been very happy with the SP, but rest assured we will do what it takes to keep Afrezza on the market and make it the success we all know it can be. Becoming more efficient, decreasing cash burn, restructuring Deerfield debt, less expensive lease, negotiating with a "number" of different jurisdictions, cash position is better, not happy with share price, will do whatever it takes to keep Afrezza on the market blah, blah, blah........SELL THE PRODUCT!
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Post by nylefty on May 10, 2017 19:03:04 GMT -5
You don't really mean "respectfully" do you? Actually, I meant what I said to sophie . At the first news of a new Ultra-Rapid-Acting insulin in Europe, I decided to learn about Fiasp. "Second-in-Class" simply doesn't carry the weight of "First-in-Class". I wanted to see if Novo Nordisk would beat MannKind to the punch in the USA. They won't, but when Fiasp becomes FDA approved they'll have a massive sales force and cash to market Fiasp here. MannKind needs to make some inroads with Afrezza before Fiasp gets here, IMO. Does anybody think that Fiasp is a good name for a drug? I can't help but think "fiasco."
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Post by gamblerjag on May 10, 2017 19:21:43 GMT -5
good point sports.. he did seem rushed with that.. Matt is not concerned about raising money.. I guess my question is "raising'? does that have to mean dilution or could he have meant that as just "money coming in"?
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Post by peppy on May 10, 2017 19:26:31 GMT -5
finanicials "As of March 31, 2017, We had 1.8 million dollars of deferred revenue related to Afrezza product that has been shipped to the third party logics provider. and whole distributers and not yet dispensed to patients. 2 mins in. investors.mannkindcorp.com/events.cfm?EventType=Webcast
Added: I am looking for this, heh "If real, here's a rough estimate by volume. I think that the cargo weight includes everything, such as container, boxes, cartons, plastic, etc. Since it's a lot more work to figure out all those variables, I just estimated the size of a box of Afrezza, calculated the volume, and divided the container volume by the carton volume for a grand total of about 40,000 cartons of Afrezza. It's a very gross estimate with some fudge. Then, I took this number times the lowest priced box of Afrezza on InternationalPharmacy.com.
$361/carton * 40,000 cartons = $14.4 million
Let's hope that's a monthly national healthcare/hospital subscription..."
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Post by mnholdem on May 10, 2017 20:14:43 GMT -5
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