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Post by mannmade on Nov 10, 2016 11:50:35 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 sees 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.
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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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Post by wmdhunt on Nov 10, 2016 12:44:33 GMT -5
I am still enthusiastic about "pain relievers" with TS. That could go in every ambulance, hospital, school, and medicine cabinet globally. Of course, smokeless MJ is interesting too. The elections in the various states seemed to go well for this legalization. The future of MNKD does look bright if we can just keep going.
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Post by dreamboatcruise on Nov 10, 2016 13:01:01 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.
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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 thekindaguyiyam on Nov 10, 2016 13:20:28 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. 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. |
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Post by babaoriley on Nov 10, 2016 13:32:49 GMT -5
I feel some sanity has now returned to the world as Adam F. has published his expected hit piece.  |
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Post by thoth on Nov 10, 2016 13:46:19 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. 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." |
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Post by james on Nov 10, 2016 13:46:24 GMT -5
mannmade 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). I don't see how the stock price goes over $1 in the next year. At $.63 as I write this, the market cap is $300M for a company that continues to bleed a large amount of money and it's not in any way apparent how that can change; not with the current market realities. The warrants at $1.50 are almost certain to never exercise. There is no help coming from that. Perhaps there something interesting will come to light from RLS someday. But, at present it might as well be a black hole. They present value of that arrangement is very low. A $10M milestone from RLS if it materializes would be burned up in 5 or 6 weeks. The same is likely true from the epi-inhaler notion. The marketability of that is pretty questionable. Maybe they can get a small partnership deal out of it and see what happens, but I am skeptical. |
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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 slugworth008 on Nov 10, 2016 13:52:43 GMT -5
I feel some sanity has now returned to the world as Adam F. has published his expected hit piece. Yes, I expected Fartstain to publish something to counter an excellent CC. Right on schedule. |
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Post by wgreystone on Nov 10, 2016 13:59:03 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. 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. With the label change, Mannkind can also potentially market Afrezza as a high BG correction drug for people with CGM. Doctors may be more willing to prescribe for this purpose if they have concern with lung function, etc. |
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Post by cjm18 on Nov 10, 2016 14:02:57 GMT -5
I see vdex as the only catalyst for script sales before mnkd hires more reps in January.
Please someone correct me on the following two items if I am mistaken.
1) There is no plan for a trial to prove afrezza causes lower a1c and fewer hypos? The trials are for titration, time in range, and dosing. Also peds approvals.
2) Also, potential rls milestone payments and the 25m sale of the Danbury facility is not included in the runway to 17Q3? These two items represent another means to extend the runway?
Thanks.
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Post by novafett on Nov 10, 2016 14:08:17 GMT -5
I feel some sanity has now returned to the world as Adam F. has published his expected hit piece. Yes, I expected Fartstain to publish something to counter an excellent CC. Right on schedule. Motleytools also chimed in with their garbage as well. |
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Post by seanismorris on Nov 10, 2016 14:12:43 GMT -5
Re: naysayers argue that Afrezza is "inferior "
It's true Afrezza appears inferior when the dosing is incorrect. I don't understand how at 'this late in the game' Afrezza isn't prescribed at the correct dosages.
We are loosing patients and credibility because docs still don't know what they are doing. It sounds like MannKind is taking steps to address this, and CGMs will help, but it's ridiculous that this wasn't addressed at the original Sanofi launch.
I doesn't look that complicated... Afrezza is rapid acting, why couldn't it be figured out 90%+ of the time correctly in one doc visit. Example, Doc gives patient snack + Afrezza sample. Doc monitors levels for 30min. Doc concludes 4 units not enough, prescribes 8. Most people could do this without a doc...
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