The parallels to exubera are starting to show!

[Deleted]

I'm a fan of history and do believe that current events are just the history we don't know yet. Put another way "The only thing new in the world is the history you don't know."  As such I have become a student of the exubera fiasco since that's the closest drug to compare afrezza to in terms of roll out, what worked and what didn't work.  And while there's a long list of differences between what exubera is vs what afrezza is - how it works, how it's different, better (afrezza that is), etc the fact is pretty clear that wall street views afrezza as pretty much identical to exubera. While I don't share that position because, clearly afrezza is not exubera, as mentioned exubera provides insight into the challenges of getting an inhaled diabetic medication into the marketplace.

At this stage what bothers me the most is the following:

1. pfizer did a slow controlled initial launch, just like sano is doing with afrezza.
2. pfizer was very concerned about having enough product to sell so they accumulated almost a billion in supply ready to go while the slow initial launch was underway.
3. pfizer was so confident in exubera taking the market by storm, they believe exubera would sell itself.

Anything sound familiar so far in terms of how afrezza is going? Lets review.

1. sano is doing a slow controlled launch, just like pfizer did with exubera.
2. sano is concerned about having enough supply.
3. sano is apparently just as confident that afrezza will sell itself based on the playbook they are following so far.

I'm also bothered that MNKD is no longer responsible for sales as that's sano's job now. We've obviously known that reality since the deal was announced but here's my problem - I'm long in MNKD betting on good sales but sales is something that ins't in MNKD's control. But I view afrezza sales as the future of MNKD.  Technosphere isn't producing any income nor is it showing signs that it will anytime soon. With MNKD's gag order on discussing T, seems it can be years before we'll hear anything on T. So MNKD is all about sales now but they have no control over sales. So I am questioning what I'm invested in with MNKD?

I also have issue with:


4. Review the initial script numbers. While they are marginally higher - and yes, sales are only marginally higher when you compare what it takes to reach blockbuster status. At this stage the difference in scripts is akin to the difference in the weight of a newborn babies.  Nine pounds is percentage wise much bigger than 7 pounds, but, we're still talking small sizes.  Same with exubera scripts vs afrezza script counts - same ball park.  So, afrezza is NOT taking the market by storm, at least not initially.  
5. Pricing is at a premium for afrezza just like they did for exubera.  Alfred said years ago that they learned the exubera lessons - apparently, they did not.
6. Insurance is placing afrezza as tier 3 at best.  That means sano has to provide deep discounts to get the price down to somewhere that a patient will pay for it.  Even needle haters will take pause in buying afrezza when they have to reach into their wallets each month to pay significantly more for a medication that may or may not cause lung cancer.  YES, I said it.  I just said what every competitor is buzzing in the ears of every doc they talk to. 
7. Endo's were conservative back in 2006 and it would seem that nothing has changed much. The endo's won't be changing their patients anytime soon in bulk. Do no harm is ruling the day just like it did back in exubera's launch.  The endo's are the gate keeper and sano isn't showing any signs that they have the magic formula with afrezza.

And finally, the excuses.  We're not but 10 weeks into the launch and the excuses why scripts are so anemic are flying already.  On top of that are the grand statements of success based on a few you tubers.  Exubera had the same type of believers as well and that didn't change the course of exubera.  When I went back to read posts in the 2005 to 2007 timeframe surrounding NKTR and pfizer it's scary crazy how similiar the posts are to today's rabid afrezza believers.  I say it that way because when I step back and take a bigger picture view, that's how it lays out.  Current events are beginning to look a lot like exubera history.

[harryx1]

If you truly believe what you wrote (and/or have inside knowledge of Sanofi's plans), why don't you just sell and move on? Why are you still holding MNKD then?

[Deleted]

Apr 8, 2015 9:00:17 GMT -5 harryx1 said:

If you truly believe what you wrote (and/or have inside knowledge of Sanofi's plans), why don't you just sell and move on? Why are you still holding MNKD then?

We don't need insider knowledge.  We're getting initial results, we're getting word on prices, we're getting word on insurance coverage, we're getting script counts, these are all information streams that are now real.  We're moving from the hope, the talk, the "plans" to execution.  And so far, as I'm stating in my original post, the playbook seems to parallel exubera way to closely for my taste.

As to your question, I'm challenging why I'm invested in MNKD right now.  I do not like what I'm seeing.

[Deleted]

You forget that there are some key learnings that both Mannkind and Sanofi have from Exubera. There are similarities in all drug launches and even more nuances. W/W TRx growth needs to start gaining some consistency as you cannot have a salesforce spending time on something that does not pay the rent and even if W/W was 15-20%, it would show a stable / positive trend.

That said, still too early in the game. If TRx growth is slow come late October, I would push the panic button. In the next few months, we should see increased Sanofi sales efforts, some DTC, hear more about Sanofi efforts to promote Afrezza at the upcoming ADA Scientific Sessions (June 5th, Boston), not to mention production lines 2&3 up and running along with a 12 unit cartridge. Some chatter about key physicians being trained later this month, 200 Key Opinion Leaders.

This whole ultra rapid acting, taking an extra dose a few hours after the meal if the blood glucose level is not low enough, reduced hypos / no stacking, moderate need to count carbs, titration etc is completely counter to the way docs have seen insulin work in their patients so taking time to get docs to understand, accept and prescribe Afrezza is not as simple as some may think.

[harryx1]

So you're saying that all the early users of Exubera raved about how fast it worked, how well they were able to control their BG, how easy it was to use, etc. etc.?

[thekindaguyiyam]

better luck to you in whatever investment you switch to.  Knowing you are dissatisfied; it's clear MNKD is not the right investment for you.  Since Alfred Mann is not going to change Mannkind's Strategy and those patients love for Afrezza; doubtfully management would agree with your hypothesis; you are making the  best decision for you to sell as fast as you can.  Good luck to ya; and goodbye.

[mnkdorbust]

One big difference in my opinion (all technical aspects aside) is today's social media. It's night and day to what social media was during E. While it can work both ways (providing pros and cons for a drug, item, etc) so far all i have seen is positive feedback. I'm not sure any salesforce in the world can compete with the power of social media and the ability to reach millions of people at relatively little to no cost. I'm not saying i'm happy with todays SP nor the script counts but we have to trust in Sanofi, Al and Mankind. Still i sleep good at night with my position. If i didn't i would probably get out of it.

[gomnkd]

@davinci

I agree with some of your points. Thanks for your independent thinking. I know it brings an impotent rage from some posters if you don't have the group think. Getting feedback from social media and presenting to endo is as insane as it gets. What blockbuster drug has to depend on no-name tweeters with no medical background to be successful? Didn't we do those FDA approved trials?

It is too early to compare Sanofi actions to Pfizer's. This is where I differ.

1) We need to know the official revenues numbers.
2) We need to know size and distribution of samples
3) We need to know the marketing plan & timing of DTC. If DTC is in Oct, longs are screwed.
4) Read Heinemann's article on Exubera fiasco. www.ncbi.nlm.nih.gov/pmc/articles/PMC2769732/
I think MNKD fixed them all.

It is good to be watchful and critical of management. Never underestimate their incompetency.

[kball]

Ducks in a row.
Not sure when and how fast sales and SP will rise, but I'm on board the A TRAIN.
Management can always be replaced at some point.

My hope is that this has huge market penetration while Al is still around for a few victory laps. He's getting up there.

[dean]

davinci, thank you for sharing your well articulated perspective.

[harryx1]

I believe I had some valid questions and what he laid out was a plan for failure. None of us know what the actual plan is and he's making a lot of assumptions to make correlations that Afrezza is taking the same path as Exebura did. So again, if anyone truly believes that then why are you invested in MNKD?

Would I like to see prescriptions running at a rate of 3000 per week, yeah but it's not realistic at such an early stage. There are still a lot of hurdles with a new drug as many have stated especially with endos.

"In 2007, tracking by TNS Media Intelligence, a marketing information service, found that companies waited an average of 15 months from the time a new drug was approved before initiating DTCPA.9 However, for some new drugs, DTCPA began within one year of approval.9,12"
www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

I think petech's comment should fit in this thread as well:

mnkd.proboards.com/thread/2161/patience-wearing-thin?page=1&scrollTo=22105

[ashiwi]

Your comparisons to Exubera are like comparing apples to oranges. Exubera was a horrible product. Plain and simple. Afrezza is the next generation of inhaled insulin which is not even in the same ball park as Exubera. Compare your I-phone 6 to the 1st cell phone you had 20 years ago. (mine was as big as a shoe box and I had 30 min a month).
Nobody knows better than SNY to launch a product.

We are only in the 2nd inning of a 9 inning game. The scripts will come.

[Deleted]

Apr 8, 2015 10:38:29 GMT -5 ashiwi said:

Your comparisons to Exubera are like comparing apples to oranges. Exubera was a horrible product. Plain and simple. Afrezza is the next generation of inhaled insulin which is not even in the same ball park as Exubera. Compare your I-phone 6 to the 1st cell phone you had 20 years ago. (mine was as big as a shoe box and I had 30 min a month).
Nobody knows better than SNY to launch a product.

We are only in the 2nd inning of a 9 inning game. The scripts will come.

I agree.  The comparison on a head to head product to product viewpoint - exubera was a horrible product.  Agreed.  Moving on to the business world and out of the scientific world, because, I'm sure you know that just because a product is good does not mean it's going to sell.  I'm looking for what sano is doing differently with afrezza vs what pfizer did with exubera.  What I'm grappling with is that the gameplan here appears identical so far in terms of a roll out as well as initial results followed by almost identical excuses as to why sales haven't taken off in the first 9 weeks (so to be 10 weeks).  

I'm too old to sit around and make grand statements about whats going to happen 20 yrs from now or pretend that I (or anyone else) has a clue.  I've been around long enough to know that when something like an initial drug launch looks like a pile of manure, smells like a pile of manure, then it's probably a rose???  

The capacity of humans to ignore what they see in favor of what they wish for is never ending.

[dreamboatcruise]

I know limited things about Pfizer's botched roll out of Exubera. Some of what you assert are things that would be interesting if they aren't just speculation. Was the early lack of marketing because "they thought it would sell itself" or by that time had they already started to lose confidence and wanted to limit losses? Was the slow launch because they thought they needed to build inventory. By the way, it was $661M in inventory written off, not a billion. Was the slow launch because their efforts to get on formularies took longer than they anticipated.

I'd also question whether Sanofi is overly concerned about building huge inventory or believe it will sell itself. I don't believe they've said either. I know people on this board are quite concerned about inventory but I don't think Sanofi has stated that slow launch has anything to do with need to build inventory... it could be, but I think it is speculation. Yes there is a need to build inventory to match uptake, but we don't know if that is the constraint on the launch timeline... and we don't know that Sanofi has a focus that is beyond what is warranted. Every company launching a drug has to build an inventory, so not sure what the specific comparison at this point is to Exubera. We also have no reason to believe Sanofi is intending for Afrezza to sell itself. There may well be a plan that for one reason or another involves stages... speculative e.g. opinion leader docs, followed by endos, followed by ADA meeting, followed by adverts to medical professionals, followed by GPs, followed by DTC. Too early to speculate on the meaning of what we've seen without inside knowledge which we don't seem to have.

Seems like the biggest issue in comparing Afrezza to Exubera is the insurance coverage. If someone has available, or the time to search for, data about coverage that compares Exubera to Afrezza that would be interesting. We know Afrezza has landed everywhere from tier one to tier three... and some formularies have not yet added (I haven't seen any specific evidence of a plan that has reviewed and then failed to add, so we it may just be timeline for review). It is not yet added to Medicare, but from what I understand, no drug this new to the market would be put on Part D already. So... is there any actual evidence this early as to whether Afrezza is doing better or worse than Exubera with regard to insurance reimbursement... probably... I just don't have the time to dig it out. Undoubtedly some smart money is working on doing that. I hope my hunch that we are doing better turns out to be true. I would expect that issue will appear in an article or analyst report in the not too distant future, once someone has compelling evidence to present.

gomnkd... why are we necessarily screwed if DTC doesn't start until Oct? Not that I think it will be that late. Are you predicting that there would be another cash crunch and need to issue more shares?

[notamnkdmillionaire]

I am all for another view point but come on man. Can you provide any proof to anything you posted. Where did Pfizer ever comment that Exubera would sell itself and that they were confident it would? Please cite the source for that. As well, Exubera wasn't covered by insurance companies AT ALL! You failed to mention that important tidbit. That isn't the case with Afrezza where insurance is covering it. It might be spotty but it's a new drug.