|
Post by goyocafe on Jan 4, 2019 19:39:12 GMT -5
So, not required. But maybe it's a good idea to get FDA to sign off on an ad before full production and release .... to avoid wasting time and money. Mike has said that the FDA rejected the first version of the current ad because it seemed to encourage diabetics to eat pizza. mnkd.proboards.com/post/162441/threadOddly, that hardly seems like a violation of any law, so the FDA must be really full of themselves to dictate that level of detail in an ad. Jmho
|
|
|
Post by peppy on Jan 4, 2019 19:49:39 GMT -5
Oddly, that hardly seems like a violation of any law, so the FDA must be really full of themselves to dictate that level of detail in an ad. Jmho they went with encouraging chicken. it seems to me, the standards of care language regarding afrezza and hypoglycemia could be a voice over, banner over. what was the new language exactly?
|
|
|
Good CC
Jan 4, 2019 19:56:03 GMT -5
Post by goyocafe on Jan 4, 2019 19:56:03 GMT -5
Oddly, that hardly seems like a violation of any law, so the FDA must be really full of themselves to dictate that level of detail in an ad. Jmho they went with encouraging chicken. it seems to me, the standards of care language regarding afrezza and hypoglycemia could be a voice over, banner over. what was the new language exactly? If they didn’t like MNKD referencing pizza in an ad, I can’t see them being favorable to referencing a pilot study, but who knows. I fully expected the ADA to acknowledge Afrezza as an equal to injectable insulin in the 2019 SOC, and they disappointed as well.
|
|
|
Good CC
Jan 4, 2019 20:14:02 GMT -5
Post by ltta on Jan 4, 2019 20:14:02 GMT -5
Oddly, that hardly seems like a violation of any law, so the FDA must be really full of themselves to dictate that level of detail in an ad. Jmho they went with encouraging chicken. it seems to me, the standards of care language regarding afrezza and hypoglycemia could be a voice over, banner over. what was the new language exactly? EXACTLY! Inexpensive! AND if the FDA does not like it... then put the old ad back on the TV and revamp.
|
|
|
Good CC
Jan 4, 2019 20:16:58 GMT -5
Post by ltta on Jan 4, 2019 20:16:58 GMT -5
they went with encouraging chicken. it seems to me, the standards of care language regarding afrezza and hypoglycemia could be a voice over, banner over. what was the new language exactly? EXACTLY! Inexpensive! AND if the FDA does not like it... then put the old ad back on the TV and revamp. Sorry, I went inside your quote Peppy!
|
|
|
Post by mnholdem on Jan 4, 2019 23:43:24 GMT -5
The screenshots peppy posted and others are reposting (you guys don't always need to hit that quote button, you know) lists changes to the ADA's Standard of Care. Information on TV ads must comply with the drug's label. Currently, Afrezza's label does not permit MannKind to claim less hypoglycemia. The STAT trial results certainly indicated that this is true about Afrezza, but the label has not been changed by the FDA to include STAT findings. It sucks, but that's the way it works with the FDA. You cannot advertise claims that are not supported in the drug label.
|
|
|
Post by hellodolly on Jan 5, 2019 8:25:43 GMT -5
While the optics of the trip to Hawaii may not be terrific, it's routine for the industry.
|
|
|
Post by agedhippie on Jan 5, 2019 8:32:13 GMT -5
I have no problem with the sales people going to Hawaii. I am very interested in which non-sales people went though.
|
|
|
Post by goyocafe on Jan 5, 2019 9:20:37 GMT -5
I have no problem with the sales people going to Hawaii. I am very interested in which non-sales people went though. I’d like to know what sales figure qualified anyone of them to go.
|
|
|
Good CC
Jan 5, 2019 11:00:38 GMT -5
Post by brianrocco on Jan 5, 2019 11:00:38 GMT -5
A quick Google search found this: www.ncbi.nlm.nih.gov/pmc/articles/PMC5998458/Direct-to-consumer (DTC) medication sales have quietly emerged as a novel way for consumers to receive prescription drugs. Recently, several medications have become readily available from their manufacturers and are sold directly to patients via prescriptions that are sent to drug companies rather than traditional pharmacies, bypassing wholesalers. Company-sponsored medication assistance programs have offered branded prescription medications directly to patients in the United States with limited incomes for years; however, this practice involves the actual sale of prescription product to a patient by a pharmaceutical company.Mike mentioned that there would be special pricing for the first 1,000 that signed up with Mannkind for direct purchase of Afrezza. Does anyone know how to contact the woman on this board who wanted to continue with Afrezza but couldn't afford the cost? Thanks.
|
|
|
Good CC
Jan 5, 2019 12:59:33 GMT -5
via mobile
Post by sportsrancho on Jan 5, 2019 12:59:33 GMT -5
A quick Google search found this: www.ncbi.nlm.nih.gov/pmc/articles/PMC5998458/Direct-to-consumer (DTC) medication sales have quietly emerged as a novel way for consumers to receive prescription drugs. Recently, several medications have become readily available from their manufacturers and are sold directly to patients via prescriptions that are sent to drug companies rather than traditional pharmacies, bypassing wholesalers. Company-sponsored medication assistance programs have offered branded prescription medications directly to patients in the United States with limited incomes for years; however, this practice involves the actual sale of prescription product to a patient by a pharmaceutical company.Mike mentioned that there would be special pricing for the first 1,000 that signed up with Mannkind for direct purchase of Afrezza. Does anyone know how to contact the woman on this board who wanted to continue with Afrezza but couldn't afford the cost? Thanks. I told her about it on Twitter this morning. Oh sorry I just realized you were talking about another person.
|
|
|
Post by letitride on Jan 6, 2019 0:00:53 GMT -5
I believe MC did the right thing in this recent capitol raise. He is about to go into an important health care conference in a position of power. Timing was great. If you were counting on MNKD to fulfill your Christmas wishes you should have known better. If you were counting on MC to do whatever it takes to continue the turn around of MNKD then I believe you just got it. MC has proven he knows how to make good deals from a position of weakness how much more can he do from a position of strength. I listened to the call this evening and believe hes on it. I for one say Let It Ride.
|
|
|
Post by morfu on Jan 6, 2019 9:09:21 GMT -5
I believe MC did the right thing in this recent capitol raise. He is about to go into an important health care conference in a position of power. Timing was great. If you were counting on MNKD to fulfill your Christmas wishes you should have known better. If you were counting on MC to do whatever it takes to continue the turn around of MNKD then I believe you just got it. MC has proven he knows how to make good deals from a position of weakness how much more can he do from a position of strength. I listened to the call this evening and believe hes on it. I for one say Let It Ride. Any time is a good time to raise cash! However, this time it was particularly unnecessary (as they still have a cash reserve and an outlook on more cash to come in) and the way the management raised the cash was particularly expensive. And like I pointed out the lack of a good explanation for a reason of the timing created a very suspicious silence.
|
|
|
Post by wyattdog on Jan 6, 2019 12:40:18 GMT -5
i thought he answered that very well. On the second question on dilution, I just want to highlight when we had asked for additional shares previously, it was really get us to the next two, three years, and we weren't sure exactly at that time how much debt we’ll be taken on, how much equity we’d be raising. How we would fix the debt. If you remember the company had almost 200 – over $250 of debt two years ago, a little over two year ago, and now today we sit here with about $105 million. So lowest amount of debt in the last 12 years, that really takes out companies and shareholders unfortunately. And we've been able to navigate a very tight window with some pretty tough restrictions on our cap structure in our company. People don't remember we had anti-dilutive warrants. We had no shares to restructure the balance sheet last year. We were pretty much at a dead end and we were able to navigate through a very tight window and really get through that process.
And so in that when I think about where we are today we structured this deal in a way that would -- we weren't sure where that 230 [ph] warrant would come in April. Would our stock price hit there or not? And we don't want to be -- this goes back to your timing, we don’t want to be dependent on that offering. And we also did not want be dependent on it, right? So you could have waited till March and you could have saw how the stock was trading, but you know if you wanted to fund the pipeline, if you want to fund a major TV campaign, at the time to do that is in Q1 not in Q2 the most TV America watches as in Q1 all the new shows launch in Q1. And you want to keep DTC going and have we waited three months. We just would've lost three more months of window opportunity to drive expansion of Afrezza. And that's really when I talk to investors and I talk to retail people, they want to say, why Afrezza not growing faster. When I say 99% of people who aren't influent, don't even know this product exist. That’s the shame, right? It's a shame on our part. It's a shame on the doctors. It's a shame on the third parties out there that this should at least be an option.
When I talk to JDRF, what are they looking forth, a drug that have less weight gain, less hypo, better time and range. We proved all three of those points in our studies and yet you don't see that being offered consistently to patients. And so we feel it's time that our consumer efforts really spike up. And we spent a good year working through those channels to see which consumer effort will work better than another. And now we take a step back. If the shares expire in April, we'll get back 40 million shares in the last offering in April this year – last year I'm sorry. And by December I do expect our stock price to be above a $1.60 and then that could bring another $40 million which would solve any potential funding issues in 2020. And if it doesn't, worst case scenario we got back now 30, 40 million shares back in our office and we still another 20 some million backing our debt. So there's always ways to restructure debt to get those shares back. So I think from an overall share count we won't be in the position we were in. But we've been able to manage dilution in a way that cleaned up the balance sheet, provide a cash, we now seven compounds to be going down the pipeline and Afrezza is growing and continue to grow for the next 10 plus years. So see nothing slowing that down. So hope it explain a little bit about the dilution. On discount it was in -- the stock was trading at $70 and in a very volatile market. I mean, we were up down, up down and so being able to price that offering at about 8.5% discount for about 15% dilution with a very fair price that we thought balanced shareholder value and making sure we funded 2019.
But the reason and few may not appreciate it, but when we laid out our 2018 plan we expect to finish up the recap by February March timeframe. We scaled the territory to 100 territories. We held these plans. And then we didn't finish up the financial restructuring for lots of reasons until September when we did the United deal. And so then I got beat up on guidance. We got beat up on script growth and vacancies and how many territories are posted, but we couldn't we still think. We manage the budgets very tightly throughout 2018 to get through the year and that wasn't a really fun process to be in.
So this year now we're funded. We've got our plans. We're executing our plan. The team is fully aligned and I feel like we're in the best position between talent, product, positioning and new marketing campaign that’s launching next week, very excited about all that coming together at once. And then I want to add something I didn't talk much about and that's really around expenses. So we'll work with Amphastar, our partner to make sure our influent purchase commitment is consistent with our demand, so that will create some value for us this year to continue to invest in commercial growth. And we also we talked about RLS as one of the seven pipeline compounds because they just raised $30 million. But we didn't talk about as we look out over 2020 and 2021 and 2022 what starts to happen is the pipeline royalties will kick in, the milestone will kick in between India, Brazil, RLS, United Therapeutics, all these new revenue streams will start to pay off over the next 36 months when we look at the future.
And that that will ultimately require less capital raises, require less capital needs and we don't know how many additional pipeline assets we'll be able to fund over the next 18 months or deal that we'll be able to close that will bring in additional cash. So we look at that the -- we now have 18 months in front of us to run the company, to make prudent choices. And we think everything we’re doing will result in additional opportunities and who knows if there'll be another capital raise or not. I mean I can't presuppose what could happen, but I would say at least we're now in control of our destiny. We have no major debts due, and we now can choose to pay things off if we need to, and we can run the company where we have to.
So, I feel very good about the overall process and I feel very good about our future and our employees are very excited about where things are going. So hope you understand some of that. I know it’s not everything you want to hear, but I also want to be transparent and direct with where we think the things are going and the future of the company. So we're excited. We think the market is very volatile this year and we're just glad we don't have to be in the capital markets, it was a significant distraction on my end. I probably spent over 20 red eyes going to New York in the last year. So I don't have to spend time doing that. I do a lot of non-deal roadshows. I'll continue to invest my time with shareholders and listening to them. But most importantly what's important consistent what I hear is show me double digit Afrezza growth consistently quarter over quarter. And that's our main focus on our on our revenue driver. And the second one is can you get more deals done with the pipeline and we're moving those products forward to bring transparency to them as we go forward in 2019.
So I want to thank everybody for their time their patience and the questions. We are very excited we'll have earnings call probably late February and I'll look forward to sharing Q4 in 2018 results with you and any updates we have at that time. Thank you again
|
|
|
Good CC
Jan 6, 2019 13:19:44 GMT -5
Post by morfu on Jan 6, 2019 13:19:44 GMT -5
i thought he answered that very well. On the second question on dilution, I just want to highlight when we had asked for additional shares previously, it was really get us to the next two, three years, and we weren't sure exactly at that time how much debt we’ll be taken on, how much equity we’d be raising. How we would fix the debt. If you remember the company had almost 200 – over $250 of debt two years ago, a little over two year ago, and now today we sit here with about $105 million. So lowest amount of debt in the last 12 years, that really takes out companies and shareholders unfortunately. And we've been able to navigate a very tight window with some pretty tough restrictions on our cap structure in our company. People don't remember we had anti-dilutive warrants. We had no shares to restructure the balance sheet last year. We were pretty much at a dead end and we were able to navigate through a very tight window and really get through that process. And so in that when I think about where we are today we structured this deal in a way that would -- we weren't sure where that 230 [ph] warrant would come in April. Would our stock price hit there or not? And we don't want to be -- this goes back to your timing, we don’t want to be dependent on that offering. And we also did not want be dependent on it, right? So you could have waited till March and you could have saw how the stock was trading, but you know if you wanted to fund the pipeline, if you want to fund a major TV campaign, at the time to do that is in Q1 not in Q2 the most TV America watches as in Q1 all the new shows launch in Q1. And you want to keep DTC going and have we waited three months. We just would've lost three more months of window opportunity to drive expansion of Afrezza. And that's really when I talk to investors and I talk to retail people, they want to say, why Afrezza not growing faster. When I say 99% of people who aren't influent, don't even know this product exist. That’s the shame, right? It's a shame on our part. It's a shame on the doctors. It's a shame on the third parties out there that this should at least be an option. When I talk to JDRF, what are they looking forth, a drug that have less weight gain, less hypo, better time and range. We proved all three of those points in our studies and yet you don't see that being offered consistently to patients. And so we feel it's time that our consumer efforts really spike up. And we spent a good year working through those channels to see which consumer effort will work better than another. And now we take a step back. If the shares expire in April, we'll get back 40 million shares in the last offering in April this year – last year I'm sorry. And by December I do expect our stock price to be above a $1.60 and then that could bring another $40 million which would solve any potential funding issues in 2020. And if it doesn't, worst case scenario we got back now 30, 40 million shares back in our office and we still another 20 some million backing our debt. So there's always ways to restructure debt to get those shares back. So I think from an overall share count we won't be in the position we were in. But we've been able to manage dilution in a way that cleaned up the balance sheet, provide a cash, we now seven compounds to be going down the pipeline and Afrezza is growing and continue to grow for the next 10 plus years. So see nothing slowing that down. So hope it explain a little bit about the dilution. On discount it was in -- the stock was trading at $70 and in a very volatile market. I mean, we were up down, up down and so being able to price that offering at about 8.5% discount for about 15% dilution with a very fair price that we thought balanced shareholder value and making sure we funded 2019. But the reason and few may not appreciate it, but when we laid out our 2018 plan we expect to finish up the recap by February March timeframe. We scaled the territory to 100 territories. We held these plans. And then we didn't finish up the financial restructuring for lots of reasons until September when we did the United deal. And so then I got beat up on guidance. We got beat up on script growth and vacancies and how many territories are posted, but we couldn't we still think. We manage the budgets very tightly throughout 2018 to get through the year and that wasn't a really fun process to be in. So this year now we're funded. We've got our plans. We're executing our plan. The team is fully aligned and I feel like we're in the best position between talent, product, positioning and new marketing campaign that’s launching next week, very excited about all that coming together at once. And then I want to add something I didn't talk much about and that's really around expenses. So we'll work with Amphastar, our partner to make sure our influent purchase commitment is consistent with our demand, so that will create some value for us this year to continue to invest in commercial growth. And we also we talked about RLS as one of the seven pipeline compounds because they just raised $30 million. But we didn't talk about as we look out over 2020 and 2021 and 2022 what starts to happen is the pipeline royalties will kick in, the milestone will kick in between India, Brazil, RLS, United Therapeutics, all these new revenue streams will start to pay off over the next 36 months when we look at the future. And that that will ultimately require less capital raises, require less capital needs and we don't know how many additional pipeline assets we'll be able to fund over the next 18 months or deal that we'll be able to close that will bring in additional cash. So we look at that the -- we now have 18 months in front of us to run the company, to make prudent choices. And we think everything we’re doing will result in additional opportunities and who knows if there'll be another capital raise or not. I mean I can't presuppose what could happen, but I would say at least we're now in control of our destiny. We have no major debts due, and we now can choose to pay things off if we need to, and we can run the company where we have to. So, I feel very good about the overall process and I feel very good about our future and our employees are very excited about where things are going. So hope you understand some of that. I know it’s not everything you want to hear, but I also want to be transparent and direct with where we think the things are going and the future of the company. So we're excited. We think the market is very volatile this year and we're just glad we don't have to be in the capital markets, it was a significant distraction on my end. I probably spent over 20 red eyes going to New York in the last year. So I don't have to spend time doing that. I do a lot of non-deal roadshows. I'll continue to invest my time with shareholders and listening to them. But most importantly what's important consistent what I hear is show me double digit Afrezza growth consistently quarter over quarter. And that's our main focus on our on our revenue driver. And the second one is can you get more deals done with the pipeline and we're moving those products forward to bring transparency to them as we go forward in 2019. So I want to thank everybody for their time their patience and the questions. We are very excited we'll have earnings call probably late February and I'll look forward to sharing Q4 in 2018 results with you and any updates we have at that time. Thank you again Well.. I see a lot of how it feel to run a company without to worry about money problems and I understand that! Also, "[..]I mean, we were up down, up down and so being able to price that offering at about 8.5% discount for about 15% dilution with a very fair price that we thought balanced shareholder value and making sure we funded 2019[..]" sound reasonable.. unless of course you happen to think (like me), that the current pricing is nowhere near the real value!
The shorts control the share price right now!
In this situation anyone who sells shares feeds the shorts and gives money away!
(and as I pointed out repeatedly, in case of the offering it was the shareholders money)
The luxury of pretending to have no money problems for 18months came as a steep price and the management is not paying the bill!
There were smarter ways to raise money if it was needed at all, Mike sold out!
|
|