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Post by compound26 on Nov 16, 2016 18:16:27 GMT -5
WARNING! Great article ahead: asweetlife.org/mannkind-markets-Afrezza-to-people-with-type-1-diabetes/Excerpt:
Despite this cascade of negative events, MannKind was happy to get the licensing back in their hands. Afrezza, they insisted, failed to achieve blockbuster status because Sanofi did a terrible job marketing the drug. Matthew Pfeffer, MannKind’s CEO, said Sanofi mistakenly focused their marketing on type 2 diabetics who were afraid of needles. He said its clinical benefits to type 1 diabetics were not addressed by Sanofi.
“Being needle phobic is not a good enough reason to change your meds,” Castagne says. “But, the real story is that people have been taking insulin the same way for years and years and this is a completely different, and better drug, than [injectable] insulin. It’s a new paradigm.”
They may have spelled Mike's name incorrectly, but then make up for the misspelling by publishing excellent remarks by Mike (and Matt). Laura Kronen was also interviewed for this piece and she is quoted praising Afrezza. , nice find! I noticed that the author himself is also a long-time type 1 diabetic. So he know what he is talking about. Alex O’Meara Alex was diagnosed with type 1 diabetes 36 years ago. Since then he has run six marathons – the first when we was 15 – and the latest a few years ago. In 2006 Alex underwent islet cell transplant and was, for some time, insulin independent. He now lives in Southeastern Arizona where he is working on a novel, teaching college English, pursuing a Master’s degree, and training to run his first 50 mile race. |
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Post by compound26 on Nov 15, 2016 19:28:04 GMT -5
Compound26. Thanks for your quick action and saving the Afrezza Story aired on World Diabetes Day. The initial video only appeared for a few hours. The backup system / Code has saved it and allows us to view it. You definitely are mentioned in dispatches. Thanks. You can now find the playable video through the following tweet: |
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Post by compound26 on Nov 14, 2016 20:19:29 GMT -5
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Post by compound26 on Nov 14, 2016 15:00:21 GMT -5
mannmade great summary. Can't agree with you more on your observations and thoughts. On Epi Hale, I think as we move forward, we will have more specific updates from time to time that may help boost PPS. On slide 20 of the Mannkind third quarter conference call, we can find the following information: 1. Pre-IND meeting scheduled for December 6, 2016 2. Briefing Book submitted to FDA
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Post by compound26 on Nov 11, 2016 19:25:46 GMT -5
Has Vdex seen any patients yet? Has anyone seen the office? Have they written any afrezza scripts? It would be nice to have 1000 Vdex offices if they are writing scripts. It seems like radio silence since their announced opening. Zero, nadder, zip updates to their website. It is not easy to start a new business. It takes time. Forget about the idea of 1,000 VDEX offices for now. It is not like McDonolds or KFC. It could have 1,000 offices. But that should take at least 10 years or longer. Realistically, if it can survive for now and then expand to a few offices in a year or two, that's a success to me. |
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Post by compound26 on Nov 11, 2016 19:18:04 GMT -5
I'm sure there might be a tendency for some to think that someone in Mike's position shouldn't have to be calling individual doctors... but I think this is simply an extension of Al Mann's philosophy of focusing on the patients. I applaud Mike's willingness to jump in and help solve the problems on the ground. There is no better way for him to learn what it will take to make Afrezza the success we know it can be than to talk to patients and doctors directly. agree. This is especially the case considering that we are still in the beginning stages of the relaunch and our TRx base is still small. Every patient and his/her satisfaction counts at this stage. |
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Post by compound26 on Nov 11, 2016 17:04:43 GMT -5
Another good example of someone with CGM and active on diabetic forum being an ideal consumer of Afrezza: "from 8.1 to 5.9 A1C in 3 months time?"Wondering when we will have enough exposure of great results of Afrezza to cause a tipping point for much wider adoption of Afrezza. Allen3 1h Thanks Sam. Sometimes you just have to try it to believe it. I want people to understand it's not always a problem with them, it's their insulin. I have learned SO much from tudiabetes.org since I got active again. Thanks to all who share information on here to help others. I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza. I had all but given up. www.tudiabetes.org/forum/t/tresiba-basal-insulin/50202/556?u=charles5 Allen ( www.tudiabetes.org/forum/t/my-try-of-afrezza/55853/93) is good example of someone who has tried out Afrezza, initially had some issues/doubts with Afrezza and then after dialed in, absolutely loves Afrezza. Below you can see a few of his posts regarding his journey on Afrezza so far: 3 months ago: Very disappointed. Will retest and try to take it before eating and wo coffee. I have stomach distress when drinking coffee due to the acid so I'm wondering if that plays into. I am going to cut out coffee for a week (if i can) and try it again. 6 weeks ago: Yep Afrezza works great for that. I will be starting my 2nd try of it soon, and one thing it does do is minimize lows. It isnt a carb to insulin match so its very flexible unlike the normal novolog type insulin. I would say you'd be the perfect candidate for it. You dont have anything to lose by try… 3 weeks ago: Hi Sam, Not sure where you got that I was frustrated from my last post... It is indeed working out great for me for the purposes I mentioned. And this is based on a rather routine schedule, it will be even more amazingly helpful when I travel or my routine gets hectic. I am definitely sticking wit…Yeah I dont use the 4's at all really. Im using 8's almost exclusively for meals and corrections. The main use for me seems to be fast corrections and to minimize the post meal spike. I still use novolog for rest of the meal as Afrezza just doesn't work as a total replacement for me. 3 days ago: I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza. One day ago: "Lately yes cause I've been too lazy to put my pump back on. If it gets too resistant I take a shot. You get really spoiled on Afrezza, the idea of taking slow novolog is just like... ugh." So his experience show that it needs time, efforts and devotion to dial in Afrezza. However, once you dial in, it is such a powerful tool that you wonder, why isn't everyone using this? |
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Post by compound26 on Nov 11, 2016 14:19:10 GMT -5
Yes and let's not forget that Mnkd shareholders win... No dilution, a cleaned up balance sheet, no more talk of BK, RS etc (for now) and a runway extended to allow for plenty of opportunity to succeed... Big win as I see it... Nothing wrong with basking in it for a few days... Gd knows we and especially the Mnkd mgmt team has felt the pain for quite some time... Monday they go back to the business of making Mnkd/AFREZZA the success we all know it can be...  The future is bright and I do realize Mnkd is still very vulnerable but we have many things to look forward to within the next 12 months which we should be able to survive even with current financing only stated to last until 3rd Q 2017: Future Possible Opportunities:RLS Epi Partner (or Substantial Progress w FDA) Back above $1.00 (will make for better future financing if needed and above $1.50 warrants kick in for additional cash) More insurance coverage Label Change Increasing scripts which will lead to increasing revenue to offset cash burn Label Change Possible International Deal Results of pediatric studies Did I miss anything? The co-promotion opportunities mentioned by Mike. A few other trials mentioned by Ray that could provide Afrezza with "unofficial" superiority status and help Afrezza uers' initiation and titration and ultimately improve retention rate. Note that the trials will be run with CGMs (or the new Abbott Libre systemand) and conducted in three to five of the most well-respected institutions in the country. Even if a small group, say 30-50 trial participants. What if say 60-80% of them achieve A1C numbers close to or below 6.0%, with their CGM graphs look like what Sam Fina, Afrezzaguy, and other early adopters shared with us? And the results are published in a few journals?Below is what Ray said in the conference call: "We recently conducted an advisory board leading to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza differentiated pharmacokinetic profile made it an invaluable option for treatment of diabetes. Afrezza clearly offers advantage to keep patients within a tight glucose target range, potentially leaning to less hyper and hyperglycaemias episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle. To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system. This study will be conducted in three to five of the most well-respected institutions in the country, adding incredibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017 where results sometimes in the fourth quarter. Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively." seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=singleAlso, let's not forget about VDEX. While I don't have any high expectation on them right now, as they perfect their model gradually, they could provide some boost to Mannkind and Afrezza. |
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Post by compound26 on Nov 11, 2016 13:36:25 GMT -5
agree Manmande. Talking with Sports yesterday we were thinking the same.. MNKD could have waited and go to arbitration.. with the possiblity of losing (maybe) but waiting 1-2 years to see any payday.. This way they get the money quicker, albeit less, and have SNY out of the picture COMPLETELY by 12/31/16!!! SNY wins by paying less now (most likely) and not having another small bio sue their butt! see it as a win win Yes and let's not forget that Mnkd shareholders win... No dilution, a cleaned up balance sheet, no more talk of BK, RS etc (for now) and a runway extended to allow for plenty of opportunity to succeed... Big win as I see it... Nothing wrong with basking in it for a few days... Gd knows we and especially the Mnkd mgmt team has felt the pain for quite some time... Monday they go back to the business of making Mnkd/AFREZZA the success we all know it can be... The future is bright and I do realize Mnkd is still very vulnerable but we have many things to look forward to within the next 12 months which we should be able to survive even with current financing only stated to last until 3rd Q 2017: Future Possible Opportunities:RLS Epi Partner (or Substantial Progress w FDA) Back above $1.00 (will make for better future financing if needed and above $1.50 warrants kick in for additional cash) More insurance coverage Label Change Increasing scripts which will lead to increasing revenue to offset cash burn Label Change Possible International Deal Results of pediatric studies Did I miss anything? The co-promotion opportunities mentioned by Mike. A few other trials mentioned by Ray that could provide Afrezza with "unofficial" superiority status and help Afrezza uers' initiation and titration and ultimately improve retention rate. Note that the trials will be run with CGMs (or the new Abbott Libre systemand) and conducted in three to five of the most well-respected institutions in the country. Even if a small group, say 30-50 trial participants. What if say 60-80% of them achieve A1C numbers close to or below 6.0%, with their CGM graphs look like what Sam Fina, Afrezzaguy, and other early adopters shared with us? And the results are published in a few journals?Below is what Ray said in the conference call: "We recently conducted an advisory board leading to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza differentiated pharmacokinetic profile made it an invaluable option for treatment of diabetes. Afrezza clearly offers advantage to keep patients within a tight glucose target range, potentially leaning to less hyper and hyperglycaemias episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle. To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system. This study will be conducted in three to five of the most well-respected institutions in the country, adding incredibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017 where results sometimes in the fourth quarter. Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively." seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=single |
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Post by compound26 on Nov 11, 2016 10:03:35 GMT -5
I think that would prove to be a mistake. I don't hold Adam in very high regard, but his opinion is an important one. If you had listened to what he has been saying for the last 2 or 3 years in regards to MNKD, you would be much better off. Let alone his poor record of predictions on Mannkind (clinical trial, FDA approval, partnership, etc.), where he was been wrong every step of the way (as Nate has pointed out, his only correct call was regarding Sanofi's termination of the partnership), this guy has been proved that he is a habitual liar and rumormonger. The latest one being that on August 31 he tweeted that he has inside source that Mannkind has tapped ATM. Now, we all know after the last conference call that Mannkind has in fact not used any part of the ATM as of September 30. AF could have easily verified the truth of such rumor (or at least gave Mannkind an opportunity to deny or clarify on the rumor) by placing a call to Mannkind. Instead he deliberately choosing not to do so. He just tweeted that he got sources that Mannkind has tapped ATM, fully knowing that his tweet would have negative impact on Mannkind's PPS. Who with any conscience and ethics would do that?
Just wondering why he is not locked up yet, like his buddy, shkreli. |
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Post by compound26 on Nov 10, 2016 15:56:19 GMT -5
I am glad they go t the insulin put accelerated, as that gives the company much needed runway and takes away the imminent danger of bankruptcy. Losing the Sanofi LT debt was a nice trick, one that I would be mighty upset about if I were a Sanofi shareholder (Matt gets lots of brownie points for that one), but it sure helps especially if they can now find a buyer for Valencia as that can probably provide another quarter of runway. Long term though, while it is nice to not have the Sanofi debt it wasn't due for another 7 years or so the cash situation is just back where it was in June or so.So it comes down to what it has always come down to; growing scripts fast enough to incentivize the financial markets. That means getting pricing to stick without the large gross to net adjustments, driving unit volume, and getting the manufacturing cost in line so that the gross margin is positive. If they do that, Mannkind will survive and if they don't this was just a temporary reprieve. Don't forget that they receive $30 M by next January for insulin they do NOT even have to purchase. I view this as a new or fresh $30 million. (Not to mention the $10 MNKD will receive next month). So NO, I don't agree the cash situation is just where it was last June or so. And as you said, they will likely get in excess of $20 for the sale of the Valencia property. agree. It was much more than "the insulin put accelerated". For the $30 million to be received first quarter 2016, Mannkind has no obligation to deliver insulin to Sanofi. If it is just insulin put accelerated, Mannkind will need to come up with insulin that presumably worth about $30 million and deliver it to Sanofi. |
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Post by compound26 on Nov 10, 2016 15:06:33 GMT -5
Folks may not like my opinion here, but I think MNKD needs much more than 1 year of cash runway to find success. I think the plan needs to extend out 2-3 years at this point. They need to demonstrate staying power and somehow deal with the label issues which might require additional testing. Something like an open label study with a different protocol could make a huge difference here. There is also the pending safety study. While I still think there is a case to be made for that study to be deferred, it is going to create a new overhang soon. I don't see much chance of the share price breaking $1.00 in the next year. MNKD really needs to be taking a conservative approach and swallow the reverse split and dilution to raise $100 - $150M. They should be doing this in the near future (30 - 60 days) while there is still some enthusiasm from this news to balance the steady drip of low scripts. They need to generate a new direction to give the market something to look forward to and the potential for some additional data could provide an emotional lift. All there is right now is some more cash to burn away on what looks to be a failed plan. The drug is too good for that. No signs that plan has failed yet. They just need to time to implement it and reap the benefit, and management has certainly pulled off extending the runway more than I thought they could without dilution. My confidence has been restored. I agree with you. I think Matt, Mike and Ray are getting more comfortable with their respective positions as CEO, CCO and CMO and they are improving themselves every day. I see them working as a great team right now. I think that's the best bet I have right now (of course, we all know Afrezza is a great product and TS is a great platform, that's given). As I stated in another post, I fully expect the management to be able to further extend the runway well into 2018 in the next few months with no significant dilution (via a combination of RLS milestones, Epi inhaler license, Afrezza international deal, ATM at a higher PPS, and proceeds from exercise of warranties when PPS is above $1.50). The fact that Mannkind has not elected to R/S and dilute or to tap the ATM by now indicates that management considers these measures to be too dilutive at the moment. I agree with the management on this point. IMHO, there is a high probability that the PPS will break $1.0 in the very near future and stay above that level for a long time (therefore address the de-listing concern) and there is a good chance that the PPS reaches $2-4 within the next 12 months. That's my feeling both before and after this conference call. I increased my exposure to Mannkind via leap by 1/2 in the few days before this conference call and may add some more later. |
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Post by compound26 on Nov 10, 2016 13:52:14 GMT -5
While the physicians may able to interpret the science of fast(est) acting.. they'd have to be interested enough to want to read the material. My guess is that the word "Ultra" would ignite the curiosity of the diabetic community and drive doctors attention to Afrezza as a new category of drug. Moreso, it's an acknowledgement from the FDA... at long last. Agree. The key here is the ability for MNKD to market Afrezza as a completely new category. Having clear separation from existing options is vital for trying to generate demand. Being able to tell doctors that "I'd like to talk to you about a completely new category of insulin" is fundamentally different from "I have an insulin that works better than existing RAAs." Agree. Less need for Mannkind sales rep to explain regarding clinical data on superiority, etc., as Afrezza is in a separate category itself. And on the other hand it will be more difficult for the naysayers to argue Afrezza is "inferior" in reducing A1Cs based on trial data, etc., as again, Afrezza is in a separate category itself. Also, it will be easier for patient to demand Afrezza with their doctor. It will be something like: "Doctor, can I get some samples to try out this new ultra-fast insulin, Afrezza?" vs now "Doctor, can I get some samples to try out this new inhaled insulin, Afrezza?" It will be harder for a doctor to dismiss the first request (compared with the second request). |
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Post by compound26 on Nov 10, 2016 13:11:24 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. I think Mannkind is taking many measures to resolve this issue. They are not just relying on the updated label of ultra-fast. See the below discussion by Ray on two of the trials they are planning: We recently conducted an advisory board leading to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza differentiated pharmacokinetic profile made it an invaluable option for treatment of diabetes. Afrezza clearly offers advantage to keep patients within a tight glucose target range, potentially leaning to less hyper and hyperglycaemias episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle. To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system. This study will be conducted in three to five of the most well-respected institutions in the country, adding incredibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017 where results sometimes in the fourth quarter. Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively. seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=single |
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Post by compound26 on Nov 10, 2016 12:07:56 GMT -5
Well patience has been rewarded and for all of the people who doubted they can now relax a bit and for the shorts they will just have to go back to their drawing boards and scheme up some new issues as money is no longer an issue until next July at the earliest... My take away from yesterday was as follows: 1. Scripts will likely not improve anytime soon but steps are being taken to methodically work on understanding the issues and providing solutions and will likely help maintain a slow progression in a positive direction. I am not expecting a big jump anytime soon. 2. The balance sheet has been cleaned up big time and this should allow for a future less harsh form of financing should it become necessary. 3. There are still the possibilities of the "Positive Unknowns" between now and July 2017 as follows: a. RLS milestone and more clarity about future impact of relationship on MannKind b. International deal c. Epi deal d. New more experienced reps having a positive impact on sales and some slight expense offsets from their repping other manufacturers drugs e. Possible new partner such as Amphistar now that there seems to be a new relationship between MannKInd and Amphistar But here is my BIG Takeaway: Am not sure if this was slip of the tongue by Ray but he said that they "expected approval for the label change by 4th Quarter of 2017," and that they were currently in on-going discussions with the FDA about it. What Ray did not say was that they were expecting to get a decision by 4th Q 2017. So either he misspoke or he is very confident and see this process as merely perfunctory. So with the above said, it would seem that no matter where scripts go over the next 12 months, and I am assuming they will continue to climb methodically in relationship to the efforts being put forth... Once the label is changed to Ultra Rapid Acting and AFREZZA is in a class by itself, we will get liftoff... BIG Time! And therefore at a minimum all MannKind has to do for the next 12 months is stay in the game... But I am confident they will do more than simply stay in the game. totally agree with your assessment. Mannkind just needs to survive and plug along steadily, which is exactly what Matt, Mike and Ray are doing. Within the next few months, if the PPS rises to some level, say $2 or above, I will expect Mannkind to tap the ATM to further extend the runway. And there will also be some exercise of warranties issued in the last round of financing. I expect these two channels to provide a few more months of runway. These sources of funds, plus expected RLS milestones (in addition to the milestone that Matt has talked about that will probably come in during 4th quarter 2016, I would expect another milestone from RLS to be triggered within 12 months after the first milestone) and possible Epi licencing fee and Afrezza international license fee, I expect the runway to be further extended to well into 2018 over the next few months, without significant dilution (tapping ATM and exercise of warranties will cause some dilution, but that is expected). Once Epi inhaler is in the clinical trial stage and moving to be approved, that will help to put a floor to the PPS. Once Epi inhaler is approved, IMHO, the Epi inhaler alone probably should be valued at $1B or plus, or $2 per share (which basically asks for $50 million peak annual profits at a 20 times PE ratio). |
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