MannKind 2.1, The Updates to MannKind 2.0

[mannmade]

Based on the last conference call I am looking at the date of 11.09.16 as the start of MannKind 2.1, which is for me, the logical update to MannKind 2.0 which was started when Sanofi returned the rights to AFREZZA back to MannKind on April 4th or so.

I think by now everyone knows the main points of what made the last conference call so positive.  So now what do I/we have to look forward to with MannKind 2.1 in the next 3 months (really the 4th Q 2016 CC)?

I am listing (my opinion only) what I think are the reasonable possibilities for near term events that should allow for the continuation of the upward movement of the share price...  Now that Mnkd has a runway into 3rd Q of 2017, short term money is not an issue and that "Money Elephant" has temporarily left the room leaving only its twin of weekly low scripts growth/counts.  

So with the money elephant gone for now, we should expect to see the following by year's end...

1. Steady (but slow) script growth, perhaps 400 to 500 per week by year's end.  (Note there will be plenty of holiday, 3 and 4 day week excuses to go around regarding slower than expected script growth...)
2. A very modest RLS payment of say $10M, which will prove they are real and that the deal is verifiable as a potential revenue stream down the road.  We may not learn much more about them, but the actual payment should be a confidence builder regarding MannKind technology and alternative revenue streams.

I believe the two items above will help us get the price back over $1.00 pps.  

Additionally, for the longer term within the next twelve months we can look forward to the following:

1. Start and Conclusion of Pediatric Study
2. Beginning of JDRF/Mnkd Long Term Safety Study plus other studies as indicated by Ray Urbanski 
3. More Robust DTC Campaign
4. Epi Hale Progress towards a early 2018 Product Launch
5. Continued Script Growth to perhaps 1,000 to 2,000 per week by year end 2017.  (I have greatly reduced my expectations for the path of script growth as I have learned just how much disbelief there is in the medical community regarding the anecdotal evidence of how good AFREZZA really is as compared to the label and allowed FDA information/communication about AFREZZA.)
6. Label Change
7. International opportunity
8. Partnership
9. Additional funds from warrants kicking in at $1.50
10. Hiring of Senior Reps as MannKind EE's*
11. Television Commercials*

(*Now with regard to the asterisks, I am not sure if the funds for those items are part of the current calculation for runway extension until 3rd Q 2017 or not.  If no,t then they must have a plan for additional funds which to me would also be a positive.  And if they are already budgeted for then even better...) 

What I see is that with the beginning of MannKind 2.1 there is a very targeted and methodical approach to supporting and growing AFREZZA's market share. This is vey important because as I have learned from my own personal experiences the resistance to change in the medical community is huge here, so it is going to take time, more time than I ever imagined for a drug that is so good...  

From what I now personally know having spoken with many Endos and doctors, that in addition to the above, MannKind will have to get more opportunistic and try to engage the voice of a few "Alpha Endos" and thought leaders to get them to publish positive articles so that the rest of the pack will follow.  

To me this will be one of the key ingredients to moving the needle.  While patient awareness and DTC are necessary to improve overall awareness and demand, without Endo/Medical understanding & acceptance of AFREZZA, we will not succeed.  As imho, no matter how many patients demand AFREZZA, if their doctor says no most will listen to their doctor and very few will take the time and energy to fight with their doctor or switch to another doctor to get it.

With the other issues of Spirometry, Insurance, etc being resolved by MannKind the above, to me, remains the most critical and number one priority to overcome in an effort to make AFREZZA the overwhelming success it should be...   

But I do personally believe MannKind is on the right path... 

 

 

[compound26]

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    

[mannmade]

Agree Compound and Ty...

[zuegirdor]

Good call on the versioning.

I think most of the list and narrative is spot on. But I wonder about the long term safety trial. I seem to remember the FDA only soft pedaled the idea. I deally you want to know long term effects before they have a chance to occur. Therefore ( and in the Analyses I read) study design should be based upon an early detection protocol. This would mean enormous (and cost prohibitive?)sample sizes of greater than 50 or 60,000 subjects. This is practically infeasible at the get go. With the background lung cancer rate at 1 per thousand or even less, for I don't know what timescale (lifetime?)the number of years the n=60K study would need to run may also be prohibitively high. But in a way this infeasiblity issue is a good thing. The reason the study may be infeasible is that the rate of lung cancer in the study was so low as to be indistinguishable form background.

As to doctors resistance, there is plenty of hypocrisy in where they draw the line in the sand. I personally know doctors that smoke and make other choices that I question. If a type 1 doctor wants Afrezza they are free to self Rx because they "have done their own risk benefit analysis as doctors and type 1 diabetics". Diabetes patients should be given the same choice whether they are doctors or not. As justification I offer the abundance of evidence of the psychological ravages wrought by Type 1 diabetes. When is someone going to do a trial on the liberation and relief from angst that Afrezza provides users? I personally know young diabetics, especially teens transitioning to young adulthood who have been crippled physically and mentally by this diseases. What is the point of worrying about even a modestly elevated incidence of pulmonary effects (not that the data even indicates such)when teen adherence and on-target BG is 10 % and adult figures are at 35%? A huge chunk of that population is going to suffer long before any prospective lung effects manifest?

[gamblerjag]

I accidentally ignored someone on here. How do you unignore them. I clicked on their name and just saw " send gift"  I did not see unblock.. Thanks.

[dreamboatcruise]

Hopefully the "time in range" trial will be something that some thought leader endos will get behind as an important development.

[seanismorris]

I don't know the status of the Pediatric Trial but that's what I'm looking for near term. If CGM was used and the trial results looked good, getting back in front of docs after the new year would be ideal. If we are going to get to 1000 scripts growth that's the way I see it happening...

I was hoping for the Label change to accelerate growth but that's been pushed way back. I can only hope that the Label change will somehow incorporate the Pediatric results.

The cancer warning wouldn't have much punch if approved for Pediatric was included...

The diabetes conferences haven't seemed to do much for sales... I'm in favor of pounding the table with that sales force.

[liane]

Nov 14, 2016 15:36:31 GMT -5 gamblerjag said:

I accidentally ignored someone on here. How do you unignore them. I clicked on their name and just saw " send gift"  I did not see unblock.. Thanks.

If you go to your own profile, and select "privacy settings", you should see a list of people you have blocked (have to scroll down a bit). You should be able to unblock there.

[peppy]

Nov 14, 2016 16:15:04 GMT -5 seanismorris said:

I don't know the status of the Pediatric Trial but that's what I'm looking for near term. If CGM was used and the trial results looked good, getting back in front of docs after the new year would be ideal. If we are going to get to 1000 scripts growth that's the way I see it happening...

I was hoping for the Label change to accelerate growth but that's been pushed way back. I can only hope that the Label change will somehow incorporate the Pediatric results.

The cancer warning wouldn't have much punch if approved for Pediatric was included...

The diabetes conferences haven't seemed to do much for sales... I'm in favor of pounding the table with that sales force.

There is no cancer warning on Afrezza label.

The warning is bronchospasm.

You must be thinking of the GLP-1 that has a thyroid cancer warning.

Try to keep the warnings straight.

here a warning, there a warning, everywhere a warning.

[gamblerjag]

Thank you Liane. It worked.

[peppy]

Nov 14, 2016 14:26:27 GMT -5 mannmade said:

Based on the last conference call I am looking at the date of 11.09.16 as the start of MannKind 2.1, which is for me, the logical update to MannKind 2.0 which was started when Sanofi returned the rights to AFREZZA back to MannKind on April 4th or so.

I think by now everyone knows the main points of what made the last conference call so positive.  So now what do I/we have to look forward to with MannKind 2.1 in the next 3 months (really the 4th Q 2016 CC)?

I am listing (my opinion only) what I think are the reasonable possibilities for near term events that should allow for the continuation of the upward movement of the share price...  Now that Mnkd has a runway into 3rd Q of 2017, short term money is not an issue and that "Money Elephant" has temporarily left the room leaving only its twin of weekly low scripts growth/counts.  

So with the money elephant gone for now, we should expect to see the following by year's end...

1. Steady (but slow) script growth, perhaps 400 to 500 per week by year's end.  (Note there will be plenty of holiday, 3 and 4 day week excuses to go around regarding slower than expected script growth...)
2. A very modest RLS payment of say $10M, which will prove they are real and that the deal is verifiable as a potential revenue stream down the road.  We may not learn much more about them, but the actual payment should be a confidence builder regarding MannKind technology and alternative revenue streams.

I believe the two items above will help us get the price back over $1.00 pps.  

Additionally, for the longer term within the next twelve months we can look forward to the following:

1. Start and Conclusion of Pediatric Study
2. Beginning of JDRF/Mnkd Long Term Safety Study plus other studies as indicated by Ray Urbanski 
3. More Robust DTC Campaign
4. Epi Hale Progress towards a early 2018 Product Launch
5. Continued Script Growth to perhaps 1,000 to 2,000 per week by year end 2017.  (I have greatly reduced my expectations for the path of script growth as I have learned just how much disbelief there is in the medical community regarding the anecdotal evidence of how good AFREZZA really is as compared to the label and allowed FDA information/communication about AFREZZA.)
6. Label Change
7. International opportunity
8. Partnership
9. Additional funds from warrants kicking in at $1.50
10. Hiring of Senior Reps as MannKind EE's*
11. Television Commercials*

(*Now with regard to the asterisks, I am not sure if the funds for those items are part of the current calculation for runway extension until 3rd Q 2017 or not.  If no,t then they must have a plan for additional funds which to me would also be a positive.  And if they are already budgeted for then even better...) 

What I see is that with the beginning of MannKind 2.1 there is a very targeted and methodical approach to supporting and growing AFREZZA's market share. This is vey important because as I have learned from my own personal experiences the resistance to change in the medical community is huge here, so it is going to take time, more time than I ever imagined for a drug that is so good...  

From what I now personally know having spoken with many Endos and doctors, that in addition to the above, MannKind will have to get more opportunistic and try to engage the voice of a few "Alpha Endos" and thought leaders to get them to publish positive articles so that the rest of the pack will follow.  

To me this will be one of the key ingredients to moving the needle.  While patient awareness and DTC are necessary to improve overall awareness and demand, without Endo/Medical understanding & acceptance of AFREZZA, we will not succeed.  As imho, no matter how many patients demand AFREZZA, if their doctor says no most will listen to their doctor and very few will take the time and energy to fight with their doctor or switch to another doctor to get it.

With the other issues of Spirometry, Insurance, etc being resolved by MannKind the above, to me, remains the most critical and number one priority to overcome in an effort to make AFREZZA the overwhelming success it should be...   

But I do personally believe MannKind is on the right path... 

 

 

I have been shocked by the physicians.

The continuous glucose monitors are absolute proof of smooth post meal glucose control provided by afrezza.

The proof does not get more in our face obvious.

Physicians can see.

Any physician can read 10 glucose monitor print outs in a minute.

Instant, concise, objective patient data.

Interesting gig. Patients with continuous glucose monitors may need to embarrass the physician with copies of other peoples anecdotal real time data, for in your face, press the issue.

Patient to physician, "I want what these people have." and give the physician the print out of 5 peoples continuous glucose monitor read outs. What is the physician going to say?

That we are not blind, that we can see with cgm's are what is going to save us.

Ha, we had to fight for the right.

[uvula]

Nov 14, 2016 16:53:41 GMT -5 gamblerjag said:

Thank you Liane. It worked.

It would still be a nice gesture if you sent them a gift. I didn't know that gift giving was possible on proboards.

[mannmade]

Peppy, simply not that simple I hate to say as you would rightly think it should be. However many doctors still think there may be long term lung issues among other things...

[peppy]

Nov 14, 2016 17:12:32 GMT -5 mannmade said:

Peppy, simply not that simple I hate to say as you would rightly think it should be. However many doctors still think there may be long term long issues among other things...

is it as simple as this mannmade? Does the physicians malpractice insurance payment go up if they prescribe?

I am digging.

I know you see what is prescribed.

[mannmade]

Unfortunately Peppy from my personal experiencers and in speaking with a couple of people I am and have tried to help get a script it is just that simple for some doctors. Now i do agree with you that eventually digital technology/cgm's will help change the perception of many docs but for a T1 in relatively good control between 6.3 and 7.0 there seems to be very little motivation or reason to assist with the switch to AFREZZA for now.