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Post by notamnkdmillionaire on Oct 5, 2015 21:15:23 GMT -5
During the last two or three calls, Matt mentioned one then a second TS application. I can not recall the specifics but do recall one analyst question him regarding the timing to human trials. While the first application has a head start, the second application will make it first into human trials. So instead of yelling, take the time to LISTEN to the conference calls. If you can not do that, please stop putting out false information. @1_percenter not sure where you're confused here. Matt was pretty blunt about the specifics & stages. Here's the quote from Matt in the Q2 conference call: Now, let me turn to our development portfolio. We made progress in the two key initiatives discussed in our last call: first, the pulmonary hypertension; and second, pain management.
Our program in pulmonary hypertension has entered the technical feasibility phase, during which we prepared for the dry powders and evaluated their aerodynamic properties, stability, and other characteristics. We expect these activities will take about six months or so, before we will have powders that can be evaluated in animal models. The pain management program is focused on the product that is intended to manage moderate-to-severe acute pain and is also in the technical feasibility phase. We have already prepared several prototype powders to formulate around a small number of active pharmaceutical ingredients or API, and we have evaluated some in preclinical models. The results have been actually very encouraging so far. The focus now is to select the optimal API and move to Investigational New Drug or IND-enabling studies. Behind these programs we identified a short list of additional product candidates for which development plans are being drafted and commercial business opportunities models. The hiring of Dr. Urbanski as Chief Medical Officer is the key step to manage these and all future new product development efforts and we look forward to providing more detailed update in our upcoming calls based on Dr. Urbanski’s work. Lastly, I want to call attention to MannKind being part of saving life at birth, a grand challenge for development program sponsored by the Gates Foundation. It was announced that the Mintaka Foundation for Medical Research was an award recipient for innovative solutions to prevent maternal infant deaths in hardest to reach regions of the world. The award recipients were selected from more than 750 submissions. The Mintaka grant that powers MannKind’s effort for dosage form development was based on work performed at MannKind to develop a highly heat-resistant and noninvasive formula of oxytocin to reduce maternal death due to postpartum hemorrhage. We offer congratulations to the members of our clinical team who contributed to this research. So in closing, MannKind is undergoing a very exciting period in the company’s history. We are seeing our flagship product Afrezza gain market visibility and be described as life-changing by diabetic users. We are watching our Afrezza work in Sanofi make great strides in the sales and marketing of this revolutionary product. We have exciting new product developments underway based on our patented Technosphere platform. You are a smart guy but those aren't definitive pipeline drugs. We still have no idea what they are other than those are the areas they are targeting. They may never see the light of day. Hence, my point of nothing definitive other than the vague generalities given by management. and remember, MNKD has been sitting on TS for over a decade and only has one "official" drug/device to show for it. The Oxy drug is great but a company can't survive on giving their tech away to charity to help the 3rd world. |
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Post by mnholdem on Oct 5, 2015 21:35:25 GMT -5
But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. I'm solely speaking from the point of commercialization of Afrezza; Technosphere's proof of concept in the market place is Afrezza. You really can't seperate the two as far as outside optics are concerned. I'm not well versed enough to deal with the question of whether the black box warning given to Afrezza would also be mandated on other applications of Technosphere. I guess the inhalation could be an issue if the FDA determined (in their infinite wisdom) that it was something inherent of Technosohere, future studies may change that determination and vindicate Afrezza. Technosphere's fate is intimately tied to Afrezza. I don't know how you got "thus you think the inhalation is the reason Afrezza is not yet successful in their eyes?" from what I had said... but I hope I've made my point clear as day. I must respectfully disagree with you, harry. The next TS drug could be launched in a couple years while Afrezza has captured perhaps 10% of the prandial insulin market, or roughly 30k scripts per week...still in its infancy, really. The other problem with your analysis is that with Afrezza, the scrutiny is necessarily more stringent because it must be administered multiple times each day for the rest of a diabetic's life (if as a Type I the pancreas cannot produce insulin). Other drugs will be administered only when needed, so the risk-benefit ratios naturally will more heavily favor the API. Technosphere's proof of concept, as you call it, is already being loudly validated by early adopters, diabetics who are shouting "freedom" from the rooftops (and on social media) and Technosphere will soon be validated with solid empirical evidence. Regarding any lung concerns, members of the ADCOM went out of their way to clarify that there was virtually no indication of Technosphere-Insulin causing lung damage in the thousands of trial patients. The 5-year post-marketing study is meant to simply put the issue to rest. Considering that with Technosphere's use in pain management and/or other applications where inhalation is required on a much less frequent basis, there will be much less concern, if any. I fully expect that whatever new Technosphere-delivered drugs emerge from the pipeline, the FEV1 test will be recommended but not required and MannKind will not have a black box warning like it temporarily does on Afrezza. So Technosphere's proof of concept in the marketplace is not based on whether Afrezza becomes a blockbuster. It's based on recognition by insurers and medical professionals that Technosphere delivers as promised. At the present moment, it's a monomeric human insulin that is being delivered to diabetics. That is unprecedented in diabetes treatment, really. Other drugs won't be so disruptive that the medical community needs this much time to disect the various health benefits, as it currently is with Afrezza. It will be much less complicated to understand pain disappearing in 5-7 minutes after inhaling a pain medication. The science of Technosphere will prevail. Afrezza may not be the biggest blockbuster to emerge from our pipeline. |
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Post by notamnkdmillionaire on Oct 5, 2015 21:36:18 GMT -5
During the last two or three calls, Matt mentioned one then a second TS application. I can not recall the specifics but do recall one analyst question him regarding the timing to human trials. While the first application has a head start, the second application will make it first into human trials. So instead of yelling, take the time to LISTEN to the conference calls. If you can not do that, please stop putting out false information. @1_percenter not sure where you're confused here. Matt was pretty blunt about the specifics & stages. Here's the quote from Matt in the Q2 conference call: Now, let me turn to our development portfolio. We made progress in the two key initiatives discussed in our last call: first, the pulmonary hypertension; and second, pain management.
Our program in pulmonary hypertension has entered the technical feasibility phase, during which we prepared for the dry powders and evaluated their aerodynamic properties, stability, and other characteristics. We expect these activities will take about six months or so, before we will have powders that can be evaluated in animal models. The pain management program is focused on the product that is intended to manage moderate-to-severe acute pain and is also in the technical feasibility phase. We have already prepared several prototype powders to formulate around a small number of active pharmaceutical ingredients or API, and we have evaluated some in preclinical models. The results have been actually very encouraging so far. The focus now is to select the optimal API and move to Investigational New Drug or IND-enabling studies. Behind these programs we identified a short list of additional product candidates for which development plans are being drafted and commercial business opportunities models. The hiring of Dr. Urbanski as Chief Medical Officer is the key step to manage these and all future new product development efforts and we look forward to providing more detailed update in our upcoming calls based on Dr. Urbanski’s work. Lastly, I want to call attention to MannKind being part of saving life at birth, a grand challenge for development program sponsored by the Gates Foundation. It was announced that the Mintaka Foundation for Medical Research was an award recipient for innovative solutions to prevent maternal infant deaths in hardest to reach regions of the world. The award recipients were selected from more than 750 submissions. The Mintaka grant that powers MannKind’s effort for dosage form development was based on work performed at MannKind to develop a highly heat-resistant and noninvasive formula of oxytocin to reduce maternal death due to postpartum hemorrhage. We offer congratulations to the members of our clinical team who contributed to this research. So in closing, MannKind is undergoing a very exciting period in the company’s history. We are seeing our flagship product Afrezza gain market visibility and be described as life-changing by diabetic users. We are watching our Afrezza work in Sanofi make great strides in the sales and marketing of this revolutionary product. We have exciting new product developments underway based on our patented Technosphere platform. One other important thing. the street hates uncertainty. The management at Mannkind has at every opportunity created uncertainty and that's why we see the huge short position and "unkindness" directed toward the company by the investment community. At some point, assuming scripts continue to disappoint, the funds will start to unload. If you think its bad now, just wait if that scenario comes to life. |
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Post by Deleted on Oct 5, 2015 21:38:34 GMT -5
od - when I recommend selling and moving on to some it is because their expectations of share price will probably continue to disappoint as it does to me. However, management is not at fault, blame Karp, Shreli and GS for spreading lies and misinformation. Owning shares of MannKind requires testicular fortified, sorry ladies, but no other way of putting it.
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Post by hankscorpio7 on Oct 5, 2015 22:08:20 GMT -5
od - when I recommend selling and moving on to some it is because their expectations of share price will probably continue to disappoint as it does to me. However, management is not at fault, blame Karp, Shreli and GS for spreading lies and misinformation. Owning shares of MannKind requires testicular fortified, sorry ladies, but no other way of putting it. Huh? Fortified testies- you mean like ramparts and turrets or something? Trebuchets? I am completely unprepared. Actually, I would rather have a level head for my investments. |
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Post by mnholdem on Oct 5, 2015 22:25:36 GMT -5
If it's alright with you, I'd prefer that we not discuss testicals with a guy who wields a flame-thrower, okay?
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Post by harrys on Oct 6, 2015 1:02:51 GMT -5
I'm solely speaking from the point of commercialization of Afrezza; Technosphere's proof of concept in the market place is Afrezza. You really can't seperate the two as far as outside optics are concerned. I'm not well versed enough to deal with the question of whether the black box warning given to Afrezza would also be mandated on other applications of Technosphere. I guess the inhalation could be an issue if the FDA determined (in their infinite wisdom) that it was something inherent of Technosohere, future studies may change that determination and vindicate Afrezza. Technosphere's fate is intimately tied to Afrezza. I don't know how you got "thus you think the inhalation is the reason Afrezza is not yet successful in their eyes?" from what I had said... but I hope I've made my point clear as day. I must respectfully disagree with you, harry. The next TS drug could be launched in a couple years while Afrezza has captured perhaps 10% of the prandial insulin market, or roughly 30k scripts per week...still in its infancy, really. The other problem with your analysis is that with Afrezza, the scrutiny is necessarily more stringent because it must be administered multiple times each day for the rest of a diabetic's life (if as a Type I the pancreas cannot produce insulin). Other drugs will be administered only when needed, so the risk-benefit ratios naturally will more heavily favor the API. Technosphere's proof of concept, as you call it, is already being loudly validated by early adopters, diabetics who are shouting "freedom" from the rooftops (and on social media) and Technosphere will soon be validated with solid empirical evidence. Regarding any lung concerns, members of the ADCOM went out of their way to clarify that there was virtually no indication of Technosphere-Insulin causing lung damage in the thousands of trial patients. The 5-year post-marketing study is meant to simply put the issue to rest. Considering that with Technosphere's use in pain management and/or other applications where inhalation is required on a much less frequent basis, there will be much less concern, if any. I fully expect that whatever new Technosphere-delivered drugs emerge from the pipeline, the FEV1 test will be recommended but not required and MannKind will not have a black box warning like it temporarily does on Afrezza. So Technosphere's proof of concept in the marketplace is not based on whether Afrezza becomes a blockbuster. It's based on recognition by insurers and medical professionals that Technosphere delivers as promised. At the present moment, it's a monomeric human insulin that is being delivered to diabetics. That is unprecedented in diabetes treatment, really. Other drugs won't be so disruptive that the medical community needs this much time to disect the various health benefits, as it currently is with Afrezza. It will be much less complicated to understand pain disappearing in 5-7 minutes after inhaling a pain medication. The science of Technosphere will prevail. Afrezza may not be the biggest blockbuster to emerge from our pipeline. I'll have to stick by my belief that Tech and Afrezza are tied up in this together, not saying it should be like in a just/fair world, but that's not the world we live in. I think the timeline by necessity needs to be much quicker than your suggestion of a "couple years" for first TS application and Afrezza capturing 10% of market... if you are correct than MNKD is dead money for another few years and I can't believe that's even possible. What happens in the next year or so is going to be an all or nothing scenario imo*. I don't believe there are any lung concerns, I was simply addressing the FDAs perspective on the matter with risk of bronchiospasm and other lung related contraindications. I have to disagree with you on the matter of early adopters validating Afrezza, BP sees nothing but green when they evaluate a future drug or technology and early adopter's aren't bringing in the $$$. When Afrezza is overflowing with $$$, only then will BP pay the price for Technosphere. That would be nice if Afrezza wasn't even the biggest tech drug but many things have to happen between now and then; I'd happily sit on this investment for a few years as long as progress is being made to this end. On the other hand I'm keeping a vigilante eye on the cash on-hand/burn/debt situation and will act accordingly if I sense further dilution. |
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Post by trenddiver on Oct 6, 2015 1:26:32 GMT -5
I must respectfully disagree with you, harry. The next TS drug could be launched in a couple years while Afrezza has captured perhaps 10% of the prandial insulin market, or roughly 30k scripts per week...still in its infancy, really. The other problem with your analysis is that with Afrezza, the scrutiny is necessarily more stringent because it must be administered multiple times each day for the rest of a diabetic's life (if as a Type I the pancreas cannot produce insulin). Other drugs will be administered only when needed, so the risk-benefit ratios naturally will more heavily favor the API. Technosphere's proof of concept, as you call it, is already being loudly validated by early adopters, diabetics who are shouting "freedom" from the rooftops (and on social media) and Technosphere will soon be validated with solid empirical evidence. Regarding any lung concerns, members of the ADCOM went out of their way to clarify that there was virtually no indication of Technosphere-Insulin causing lung damage in the thousands of trial patients. The 5-year post-marketing study is meant to simply put the issue to rest. Considering that with Technosphere's use in pain management and/or other applications where inhalation is required on a much less frequent basis, there will be much less concern, if any. I fully expect that whatever new Technosphere-delivered drugs emerge from the pipeline, the FEV1 test will be recommended but not required and MannKind will not have a black box warning like it temporarily does on Afrezza. So Technosphere's proof of concept in the marketplace is not based on whether Afrezza becomes a blockbuster. It's based on recognition by insurers and medical professionals that Technosphere delivers as promised. At the present moment, it's a monomeric human insulin that is being delivered to diabetics. That is unprecedented in diabetes treatment, really. Other drugs won't be so disruptive that the medical community needs this much time to disect the various health benefits, as it currently is with Afrezza. It will be much less complicated to understand pain disappearing in 5-7 minutes after inhaling a pain medication. The science of Technosphere will prevail. Afrezza may not be the biggest blockbuster to emerge from our pipeline. I'll have to stick by my belief that Tech and Afrezza are tied up in this together, not saying it should be like in a just/fair world, but that's not the world we live in. I think the timeline by necessity needs to be much quicker than your suggestion of a "couple years" for first TS application and Afrezza capturing 10% of market... if you are correct than MNKD is dead money for another few years and I can't believe that's even possible. What happens in the next year or so is going to be an all or nothing scenario imo*. I don't believe there are any lung concerns, I was simply addressing the FDAs perspective on the matter with risk of bronchiospasm and other lung related contraindications. I have to disagree with you on the matter of early adopters validating Afrezza, BP sees nothing but green when they evaluate a future drug or technology and early adopter's aren't bringing in the $$$. When Afrezza is overflowing with $$$, only then will BP pay the price for Technosphere. That would be nice if Afrezza wasn't even the biggest tech drug but many things have to happen between now and then; I'd happily sit on this investment for a few years as long as progress is being made to this end. On the other hand I'm keeping a vigilante eye on the cash on-hand/burn/debt situation and will act accordingly if I sense further dilution. Harrys, I'm expecting the question of cash and liquidity to come up at the next CC. I hope our CFO is prepared for the question and comes up with a credible answer. He said no dilution on the repayment of the notes, but instead iMNKD is having to use its valuable cash reserves to pay the notes. To replenish the cash reserves either more debt or equity will be required and neither can be obtained on favorable terms because of the uncertainty surrounding the Company's operations. Trend |
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Post by mnholdem on Oct 6, 2015 6:57:21 GMT -5
harrys,
If you consider capturing 10% of the prandial market to be "dead money" then I suggest you go and buy a new calculator. Also, a BP will certainly pay the $$$ for Technosphere when faced with the certainty of what a Technosphere application will do with a generic API that directly competes with the BP's brand in their market space. They would also want to avoid another BP signing a distribution agreement with MannKind and/or providing management the upfront cash needed to develop the API and bring it to market because at that point they would be screwed.
Remember, the API that MannKind is loading into Technosphere particles are already FDA-approved drugs. So is Technosphere itself, as well as the inhalers. The API were specifically selected because they can be expedited through the FDA's drug-approval process and a much lower expense than it took for Afrezza. That equates to less financial risk for the BP/financier considering investing in a partnership with MannKind Corporation. In other words, if MannKind can get the FDA to approve a drug as difficult as insulin, they can certainly succeed with other drugs.
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Incidentally, trenddiver gets to the point of why with many companies' stocks - especially biotech companies - large special interests collaborate with others (including Wall Street pundits) to drive pps into the ground. It makes getting financing more difficult, enabling investment banks to get charge higher interest and less favorable terms on the debt instruments startup companies need to stay afloat. MannKind, in spite of what AF would have you believe, is far from being in dire straits financially.
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Cashing out the settlement was not, as AF claims, the worst case scenario. Excessive stock dilution would have been worse, which was why MannKind set a floor price to prevent it. We also have 9 million borrowed shares being returned by Bank of American and which can be converted into cash (if needed) without further diluting outstanding shares since they are already outstanding shares that have been actively trading for years.
Naturally, those special interests who stand to gain by lower share prices will publish their version of what constitutes "worst case" so read AF, but try not to be fooled by his ilk. They have only the banks' interests at heart, and not the retail/commercial investor. |
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Post by notamnkdmillionaire on Oct 6, 2015 7:40:54 GMT -5
harrys,
If you consider capturing 10% of the prandial market to be "dead money" then I suggest you go and buy a new calculator. Also, a BP will certainly pay the $$$ for Technosphere when faced with the certainty of what a Technosphere application will do with a generic API that directly competes with the BP's brand in their market space. They would also want to avoid another BP signing a distribution agreement with MannKind and/or providing management the upfront cash needed to develop the API and bring it to market because at that point they would be screwed.
Remember, the API that MannKind is loading into Technosphere particles are already FDA-approved drugs. So is Technosphere itself, as well as the inhalers. The API were specifically selected because they can be expedited through the FDA's drug-approval process and a much lower expense than it took for Afrezza. That equates to less financial risk for the BP/financier considering investing in a partnership with MannKind Corporation. In other words, if MannKind can get the FDA to approve a drug as difficult as insulin, they can certainly succeed with other drugs.
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Incidentally, trenddiver gets to the point of why with many companies' stocks - especially biotech companies - large special interests collaborate with others (including Wall Street pundits) to drive pps into the ground. It makes getting financing more difficult, enabling investment banks to get charge higher interest and less favorable terms on the debt instruments startup companies need to stay afloat. MannKind, in spite of what AF would have you believe, is far from being in dire straits financially.
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Cashing out the settlement was not, as AF claims, the worst case scenario. Excessive stock dilution would have been worse, which was why MannKind set a floor price to prevent it. We also have 9 million borrowed shares being returned by Bank of American and which can be converted into cash (if needed) without further diluting outstanding shares since they are already outstanding shares that have been actively trading for years.
Naturally, those special interests who stand to gain by lower share prices will publish their version of what constitutes "worst case" so read AF, but try not to be fooled by his ilk. They have only the banks' interests at heart, and not the retail/commercial investor. 10% capture? One can hope but so far projections of what AFrezza should be at are horrendously short of any internal projections. SNY hasn't admitted it buy MNKD has indirectly. Is it no wonder why SNY won't say squat about Afrezza? If Afrezza had sold out of the gate, you can bet Sanofi would have talked about it. But nope. Afrezza isn't sellling folks. And it might never sell or do what we had hoped it would. The cold hard fact is that so far Afrezza is an unmitigated disaster and it will only have a chance if SNY can clean up the label. One can only hope that SNY has patience with it. It would be nice if SNY verbally told the market this but nope, they haven't and most likely won't. Until then, we get the bogus rumors on YMB and the relentless zombie shorts ripping into the company like its a defenseless baby unable and unwilling to fight back. I can't wait to hear Hakan and Matt stumble over their words this week and cause more uncertainty and confusion as they typically do. |
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Post by cfield23 on Oct 6, 2015 7:52:07 GMT -5
od - when I recommend selling and moving on to some it is because their expectations of share price will probably continue to disappoint as it does to me. However, management is not at fault, blame Karp, Shreli and GS for spreading lies and misinformation. Owning shares of MannKind requires testicular fortified, sorry ladies, but no other way of putting it. I know you directed it at me, but I truly am unsure why. Not quite sure where you picked up the idea that I'm impatient. I am not selling. My investment horizon is likely longer than yours. Respectfully, I won't be taking your "advice". |
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Post by hankscorpio7 on Oct 6, 2015 8:42:10 GMT -5
I hope your version is correct mnholdem. But the lack of interest in TS to this point would support a different theory. What did it cost MNKD to get insulin passed? $2b? And with how difficult a time the FDA gave Mnkd, I doubt new TS applicants will be able to reduce any costs or duration with the testing process. None of the trials for passing their drug dealt with exposure to lung tissue. So for those BPs, it becomes a gamble of where is the best area to put funds- pay MNKD a slice of profits while paying all costs to try to get TS passed but then have to worry about Hillary and her promise to limit profits and patents for derivative meds, develop their own alternate pathway, or put the funds into new candidates or simpler derivatives- i.e. change from 8hr to 24 hr dose. They also have to exclude asthma sufferers, low lung function, and possibly smokers from potential profits- unless that label changes which it probably won't for next few years. For those on the bubble, Afrezza sales will not be encouraging to gamble on TS at this point.
TS success will, in all probability occur, only if MNKD has a position of strength. Make a deal with us or we will takeover your market like we did insulin. Which would lead me to conclude, updates on preclinical TS applications are a sideshow. Mnkd does not want the one trick pony valuation but that is what they get until they have enough cash to take another TS candidate through testing. The SNY partnership will be exponentially powerful if Afrezza takes off- all the areas SNY is in will be fearful of not having an inhalable product. But, that is a huge leap from here.
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Post by kball on Oct 6, 2015 8:49:43 GMT -5
Any chance the new CMO gives the presentation along with (probably) Matt?
I get this is a financial conference, but Matt always seems a bit cryptic and meandering.
Wouldn't mind another approach to information dissemination.
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Post by Deleted on Oct 6, 2015 9:10:45 GMT -5
od - when I recommend selling and moving on to some it is because their expectations of share price will probably continue to disappoint as it does to me. However, management is not at fault, blame Karp, Shreli and GS for spreading lies and misinformation. Owning shares of MannKind requires testicular fortified, sorry ladies, but no other way of putting it. I know you directed it at me, but I truly am unsure why. Not quite sure where you picked up the idea that I'm impatient. I am not selling. My investment horizon is likely longer than yours. Respectfully, I won't be taking your "advice". @cfield - my comment was directed at od, not at you. |
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Post by cfield23 on Oct 6, 2015 9:33:38 GMT -5
But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. The reason Afrezza is not being prescribed currently as the first choice in diabetes treatment is because (1) physicians are too busy and lazy to to follow the latest developments and new products and (2) insurance coverage. These issues will be resolved in a year or two. If you are expecting blockbuster status before then I suggest selling and moving on. @kastanes, this is what I was referring to. I thought you were quoting me, and telling me to move on. If not, my bad. |
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