3 years refills still outnumbered by new scripts

[jonny80s]

At this point refills should be greatly outnumbering new scripts.... at a magnitude of 5-20 or more.

270 new scripts now should be 270 refills a few months down the road. 

Why haven't refills gone parabolic???  

Why is no one asking this question at the quarterly calls?


The only thing that makes sense is that people are not using afrezza as their primary insulin.  Instead they are using it for out of control correction dosing.

 

[madog365]

Here is an old post i made about the refills problem.

IMO the problems with refill rate can be broken down into 3 categories:

1. People who do not titrate correctly, and therefore afrezza does not work for them.
2. People who like afrezza but cannot continue using it due to insurance problems and cannot afford out of pocket costs.
3. People who use afrezza sparingly ONLY for as needed corrections, they would not need refills for many months.

All three categories are very popular in user testimonials i've seen on online message boards so let's break them down and how Mannkind is solving all three since Mike Castagna joined the team.

Number 1. One of the first things Mike did was create the titration pack, a combination pack of units designed to let patients experiment with what works best for them. Diabetes is not a one size fits all disease and therefore a one size fits all dosing doesn't always work for patients. The titration pack worked but patients still are struggling with changing their old school mindset that decades of injectables insulin usage has created. If you follow the comments you will see patients commonly calling it out that when they first try Afrezza they sometimes think it does not work for them. This is due to not taking enough units most of the time, something that is quite common and will be fixed with the new label and additional prescriber education. The other big issue is that what works for the first few weeks of Afrezza may not continue to work within those first few months which is likely why Mike expanded the titration pack to be an up to 90 day prescription. Titration is a key period but so is getting HELP along the way. When patients are getting support from Afrezza advocates with experience, they almost always get it right and i've seen how powerful that is. I think that is one of the cornerstones of the One Drop collaboration and the reason they are doing this new study, there is going to be some really good refill results for patients who titrate with help from a one drop expert.

2. Pretty common issue that comes up is insurance problems, and not just getting the first fill but especially when refilling a prescription. Not only that but this even happens for the patients who have been on afrezza for years now, who all of a sudden get declined and must go through the appeals process year after year. One of the big wins with the label change is the idea that it will help Mannkind renegotiate it's contracts with these insurance companies. Getting afrezza out of tier 3 and into tier 2, no prior authorization across the board will be a huge boost to refill rate. This was a big focus for Mannkind and one that i expect improves significantly for next year. We've also all also heard "Uber of Diabetes", Mike's ideas about cutting out the middle man and going direct to consumer, while it's a novel idea i don't see it impacting us in the short term but potentially could be a revolutionary idea for long term Afrezza sales.

3. This group is interesting, I've read about many who keep Afrezza as a tool in the toolkit but don't use it daily only once in a while for serious highs or a cheat meal. Hospitals too which keep Afrezza stocked but may not need consistent orders. I'm actually hoping Mannkind has some ideas to get more of these types of use cases as they could make Afrezza the must have tool out there - One thing i have seen is the "Monopack" language being trademarked and i'm hoping this will be a new packaging available for these types of one off use cases. Keep in mind these users are already Afrezza approved and although they use it sparingly now they are much likelier to become full time users then somebody who still has to go through the education process.

-M

---

Now a quick update to that post. As you can see the refill problem is very complex BUT i want to comment on what happens when patients DON't have trouble getting their RX via their insurance, and have proper expert guidance in titrating afrezza.

Here is an excerpt from a recent VDEX PR:

"Vdex is concerned that, regardless of the positive developments about the labeling, if a physician does not have time to properly instruct the patient in its use, Afrezza will continue to be an under-utilized product. Further, there is still a high drop-out rate among patients, suggesting that patients are not seeing the benefits of the product. Estimates put the retention rate generally at less than 50%. In contrast, Vdex’ retention rate is above 90%."

“We at Vdex believe the high drop rate is directly related to the amount of time physicians are spending with patients. It takes time to get patients using Afrezza properly, but when a patient gets proper instruction, the results are excellent. We’ve seen that exact thing with our patients,” added McCullough. “That’s why we created this program.”

90% retention rate!

[celo]

It would be nice to see Afrezza with a 3:1 margin of refill to new, as can be seen with some of their competitors; Humalog, Novalog and Apidra. Some of the lack of refills can be attributed to the new titration packs and a longer period between refills. Most of the reason, I believe, is due to patients not seeing the necessary outcomes to pay a higher amount for Afrezza. A lot of work is still necessary bringing insurers and doctors on board. It sounds like Mannkind has been very helpful to anyone prescribed Afrezza. Really would love to see that refill amount grow every week as it has been doing.

[jred]

Would be interested to know your basis for suggesting "at a magnitude of 5-20 or more".

If you think refills issue wasn't addressed in last call I suggest listening to it again and basing your questions off of that.

[compound26]

Nov 27, 2017 11:27:23 GMT -5 madog365 said:

Here is an old post i made about the refills problem.

IMO the problems with refill rate can be broken down into 3 categories:

1. People who do not titrate correctly, and therefore afrezza does not work for them.
2. People who like afrezza but cannot continue using it due to insurance problems and cannot afford out of pocket costs.
3. People who use afrezza sparingly ONLY for as needed corrections, they would not need refills for many months.

All three categories are very popular in user testimonials i've seen on online message boards so let's break them down and how Mannkind is solving all three since Mike Castagna joined the team.

Number 1. One of the first things Mike did was create the titration pack, a combination pack of units designed to let patients experiment with what works best for them. Diabetes is not a one size fits all disease and therefore a one size fits all dosing doesn't always work for patients. The titration pack worked but patients still are struggling with changing their old school mindset that decades of injectables insulin usage has created. If you follow the comments you will see patients commonly calling it out that when they first try Afrezza they sometimes think it does not work for them. This is due to not taking enough units most of the time, something that is quite common and will be fixed with the new label and additional prescriber education. The other big issue is that what works for the first few weeks of Afrezza may not continue to work within those first few months which is likely why Mike expanded the titration pack to be an up to 90 day prescription. Titration is a key period but so is getting HELP along the way. When patients are getting support from Afrezza advocates with experience, they almost always get it right and i've seen how powerful that is. I think that is one of the cornerstones of the One Drop collaboration and the reason they are doing this new study, there is going to be some really good refill results for patients who titrate with help from a one drop expert.

2. Pretty common issue that comes up is insurance problems, and not just getting the first fill but especially when refilling a prescription. Not only that but this even happens for the patients who have been on afrezza for years now, who all of a sudden get declined and must go through the appeals process year after year. One of the big wins with the label change is the idea that it will help Mannkind renegotiate it's contracts with these insurance companies. Getting afrezza out of tier 3 and into tier 2, no prior authorization across the board will be a huge boost to refill rate. This was a big focus for Mannkind and one that i expect improves significantly for next year. We've also all also heard "Uber of Diabetes", Mike's ideas about cutting out the middle man and going direct to consumer, while it's a novel idea i don't see it impacting us in the short term but potentially could be a revolutionary idea for long term Afrezza sales.

3. This group is interesting, I've read about many who keep Afrezza as a tool in the toolkit but don't use it daily only once in a while for serious highs or a cheat meal. Hospitals too which keep Afrezza stocked but may not need consistent orders. I'm actually hoping Mannkind has some ideas to get more of these types of use cases as they could make Afrezza the must have tool out there - One thing i have seen is the "Monopack" language being trademarked and i'm hoping this will be a new packaging available for these types of one off use cases. Keep in mind these users are already Afrezza approved and although they use it sparingly now they are much likelier to become full time users then somebody who still has to go through the education process.

-M

---

Now a quick update to that post. As you can see the refill problem is very complex BUT i want to comment on what happens when patients DON't have trouble getting their RX via their insurance, and have proper expert guidance in titrating afrezza.

Here is an excerpt from a recent VDEX PR:

"Vdex is concerned that, regardless of the positive developments about the labeling, if a physician does not have time to properly instruct the patient in its use, Afrezza will continue to be an under-utilized product. Further, there is still a high drop-out rate among patients, suggesting that patients are not seeing the benefits of the product. Estimates put the retention rate generally at less than 50%. In contrast, Vdex’ retention rate is above 90%."

“We at Vdex believe the high drop rate is directly related to the amount of time physicians are spending with patients. It takes time to get patients using Afrezza properly, but when a patient gets proper instruction, the results are excellent. We’ve seen that exact thing with our patients,” added McCullough. “That’s why we created this program.”

90% retention rate!

Excellent summary on the refills issues.  Mannkind also discussed this issue on the last CC.  Here is what Pat said regarding this:

seekingalpha.com/article/4122005-mannkinds-mnkd-ceo-michael-castagna-q3-2017-results-earnings-call-transcript?part=single

Another thing I wanted to talk about if you look at the gray colored line on the slide, that is the refill line and we do get questions on refills. So I wanted to take a moment to walk through some of the things, some of the thoughts and insights around that. This is something as I said we do watch on a regular basis but first and foremost whenever you're growing a brand it is essential and very critical to have the NRx line exceed the refill rate to accelerate your growth. That's exactly what's happening and we expect to see this continue in the future.

Now in July we also made a committed effort to shift from the old SKUs to the new SKUs, a proportion of our Afrezza business. We removed one SKU with the label update and plan to phase out two more SKUs in the next three to six months. This is an effort to streamline and simplify our NDC portfolio for both patients as well as providers.

And next we know that not every prescription is for a 30 day supply of insulin. For example some patients use Afrezza in addition to their comp, others use mail order that may have larger quantities, and some patients simply are not compliant and don't follow the suggested dosing regimen. And we know that these do have some impact to the refill rates.

So let's take a little closer look at the trending of some of the newer versus older SKUs that I referenced before. And what you can see in the graph is a representation of these two groups of SKUs, the ones that were phasing out as well as the new ones over the time period of May to September of 2017. So let's first look at the SKUs that we're facing now, and those are represented by the blue bar and you can see from May through September there's been about a 31% reduction in TRx volume. Over that same period the group of new Afrezza SKUs which is represented by the grey bars have experienced significant growth in TRx volume. Once again when you have a transition like this going on we do believe that it has some impact on the refill rate.

[jonny80s]

50% retention, no way. Refills would number close to a thousand/wk by now if that were the case. Hypothetically: 3 month prescriptions @ 200 new nrx a week wtih 50% retention. Every 12 weeks you should see the refill rate bump 100. End of month 6 200/wk refills end of month 9 300 refills/wk, end of 12 months 400 refills/wk...... 36 months 1200 refills/wk.

Our retention rate is closer to 5% from the start. Most current 12 week retention is close to 25%.

[sophie]

Another possibility is that the instructions and quantities of past prescriptions may not have been sufficient once properly titrated.

If a script is written for 8 units instead of 12, the patient will run out of medication too quickly, necessitating a new prescription with updated instructions to allow for a greater billing quantity. I'm fairly certain this would account for a noticeable amount of new vs refilled rx.

[casualinvestor]

Nov 27, 2017 13:49:00 GMT -5 jonny80s said:

50% retention, no way. Refills would number close to a thousand/wk by now if that were the case. Hypothetically: 3 month prescriptions @ 200 new nrx a week wtih 50% retention. Every 12 weeks you should see the refill rate bump 100. End of month 6 200/wk refills end of month 9 300 refills/wk, end of 12 months 400 refills/wk...... 36 months 1200 refills/wk.

Our retention rate is closer to 5% from the start. Most current 12 week retention is close to 25%.

You're forgetting that continuing users have to get an NRx every 3 months (for a 1-month script with 2 refills) or every 9 months (for a 3-month script with 2 refills). In a steady state scenario, refills can only be twice as large as NRx. Put another way, with 100% retention but no new prescriptions, you will still have 33% NRx and 66% refill.

Aside from that, people changing their perscription due to figuring out dosage needs can account for more NRx's. Which is a lot like more NRx's due to SKU changes. 

We don't have the data to evaluate retention just from Symphony scripts. Mannkind does, and that's probably where VDEX is getting their <50% number

[jonny80s]

Nov 27, 2017 15:22:18 GMT -5 casualinvestor said:

Nov 27, 2017 13:49:00 GMT -5 jonny80s said:

50% retention, no way. Refills would number close to a thousand/wk by now if that were the case. Hypothetically: 3 month prescriptions @ 200 new nrx a week wtih 50% retention. Every 12 weeks you should see the refill rate bump 100. End of month 6 200/wk refills end of month 9 300 refills/wk, end of 12 months 400 refills/wk...... 36 months 1200 refills/wk.

Our retention rate is closer to 5% from the start. Most current 12 week retention is close to 25%.

You're forgetting that continuing users have to get an NRx every 3 months (for a 1-month script with 2 refills) or every 9 months (for a 3-month script with 2 refills). In a steady state scenario, refills can only be twice as large as NRx. Put another way, with 100% retention but no new prescriptions, you will still have 33% NRx and 66% refill.

Aside from that, people changing their perscription due to figuring out dosage needs can account for more NRx's. Which is a lot like more NRx's due to SKU changes. 

We don't have the data to evaluate retention just from Symphony scripts. Mannkind does, and that's probably where VDEX is getting their <50% number

Based on the analysis our sales reps are pulling in 2-3 scripts a week?  No matter how you look at it, it is dismal at this point. 


If the current trend continues we may break even 12-18 months down the road.  Hence the 140mil shares.  

[me]

Nov 27, 2017 13:49:00 GMT -5 jonny80s said:

50% retention, no way. Refills would number close to a thousand/wk by now if that were the case. Hypothetically: 3 month prescriptions @ 200 new nrx a week wtih 50% retention. Every 12 weeks you should see the refill rate bump 100. End of month 6 200/wk refills end of month 9 300 refills/wk, end of 12 months 400 refills/wk...... 36 months 1200 refills/wk.

Our retention rate is closer to 5% from the start. Most current 12 week retention is close to 25%.

That's not even a hypothetical.  Refills aren't counted that way.  When someone gets a new Rx, it has a specific number of refills, but the days supply are never greater than one year.  That means that for someone on Afrezza who regularly refills a 90 DS, they would have 1 x NRx in Month 1, and a Refill in Months 4, 7 and 10, with another NRx in the following Month 1.  This last script is counted as a NRx, not a refill.

While not exact, a good estimation of a retention range would be to divide Refills in Week X by NRx in Week X-12.  Do this for each of the most recent Y weeks and look at the average.  Additionally, to get an estimate of the other end of the range of retention, divide Refills in Week X by NRx in Week X-4.  Do this for each of the most recent Y weeks and look at the average.  These two results (assuming you haven't gone back to prior to the new sales force) should give you a reasonable upper and lower limit on retention.  Of course, as has been pointed out here in numerous posts, you can't calculate retention exactly because there is still a lot of noise in these numbers with regard to actual DS splits, samples, individual titration adjustments (which will result in a NRx and not a Refill) and changes in the DS of a script, among others.

[peppy]

Nov 27, 2017 16:43:13 GMT -5 me said:

Nov 27, 2017 13:49:00 GMT -5 jonny80s said:

50% retention, no way. Refills would number close to a thousand/wk by now if that were the case. Hypothetically: 3 month prescriptions @ 200 new nrx a week wtih 50% retention. Every 12 weeks you should see the refill rate bump 100. End of month 6 200/wk refills end of month 9 300 refills/wk, end of 12 months 400 refills/wk...... 36 months 1200 refills/wk.

Our retention rate is closer to 5% from the start. Most current 12 week retention is close to 25%.

That's not even a hypothetical.  Refills aren't counted that way.  When someone gets a new Rx, it has a specific number of refills, but the days supply are never greater than one year.  That means that for someone on Afrezza who regularly refills a 90 DS, they would have 1 x NRx in Month 1, and a Refill in Months 4, 7 and 10, with another NRx in the following Month 1.  This last script is counted as a NRx, not a refill.

While not exact, a good estimation of a retention range would be to divide Refills in Week X by NRx in Week X-12.  Do this for each of the most recent Y weeks and look at the average.  Additionally, to get an estimate of the other end of the range of retention, divide Refills in Week X by NRx in Week X-4.  Do this for each of the most recent Y weeks and look at the average.  These two results (assuming you haven't gone back to prior to the new sales force) should give you a reasonable upper and lower limit on retention.  Of course, as has been pointed out here in numerous posts, you can't calculate retention exactly because there is still a lot of noise in these numbers with regard to actual DS splits, samples, individual titration adjustments (which will result in a NRx and not a Refill) and changes in the DS of a script, among others.

using the above model, can someone on the board make a calculation?

[sportsrancho]

BTW....

[pguererro]

Mannkind 2.0 relaunch has been going on long enough refills should be much better. Yes the Titration Kits extend refills. Yes many patients didn’t titrate. Yes insurance coverage sucks. However there are a scary amount of patients that try Afrezza and just don’t like it.

[cjm18]

Nov 27, 2017 21:38:05 GMT -5 pguererro said:

Mannkind 2.0 relaunch has been going on long enough refills should be much better. Yes the Titration Kits extend refills. Yes many patients didn’t titrate. Yes insurance coverage sucks. However there are a scary amount of patients that try Afrezza and just don’t like it.

What don't they like? How can vdex have over 90% retention?

[ezmit]

Nov 27, 2017 21:38:05 GMT -5 pguererro said:

Mannkind 2.0 relaunch has been going on long enough refills should be much better. Yes the Titration Kits extend refills. Yes many patients didn’t titrate. Yes insurance coverage sucks. However there are a scary amount of patients that try Afrezza and just don’t like it.

Where have you seen this?

I generally only see mostly positive comments. Negative comments on the drug are usually based on cost and lack of insurance covg. It's pretty rare that I see flat out real complaints on the drug itself. And some of those were people who only tried briefly before we had new packaging, most likely under dosing.