My take before I forget it all

[dudley]

Matt was very firm and excited.  Went out of his way to assure patients that Afrezza - and Mannkind - are here to stay.

Team is very excited and energized - MUCH more so than with Sanofi doing things.

Multiple TS fronts, expect the first deal to be announced any time - thought it would even be today. 

Multiple discussions underway, both on their own and potential partners.  Mentioned international parties numerous times.  Key is getting production volumes up for best returns.

Much more active communication in the future.  Social media both as teaching and selling tool as well as communication tool - completely lacking under Sanofi.

On-site care centers linked to endo offices.  Staffed with medical professionals who CAN write scripts on the spot and do the spirometry tests.  Patient walks in, consults, does the spirometry and walks out with the script - fabulous.

Seriously addressing pricing strategy - Matt always wanted parity with current competition but Sanofi insisted on premium pricing.

Multiple cash strategies.  Up front payments for international, licensing for TS, sale of Valencia property (thought around $23 Million).  Sounds like there is a decent shot at a "parting of the ways " payment from Sanofi.

Two studies completed by Sanofi - not published results yet but Matt very firmly said the results were good and would be shown at ADA meeting.

Still have to do the long term safety test but well into the future - 5 or 6 years.  Looking for innovative approach to save money yet satisfy FDA

21st century marketing as opposed to "1990's sales rep to doctor" - very difficult and expensive to do that.

More but it is already slipping out of my memory bank.

My takeaway is extremely positive energy, virtually everything Matt said made perfect sense to me.  Huge optimism in his words and demeanor.  "I will make it my life's mission to see Al Mann's vision comes to fruition"  (May be slightly different words but Matt said that directly)

I have to admit it was MUCH better than I personally expected.  I give Matt a very solid A- under some very pressurized circumstances.

[nylefty]

Terrific job by Matt. If I wasn't already tapped out I'd buy more MNKD tomorrow.

[james]

Here are my crib notes - quickly taken, so apologize for the format and possible inaccuracies:

1/13/2016 - 3:30PST
MNKD 2.0
Things are happening quickly
Duane issue not related to SNY withdrawl
Afrezza is here to stay - we will make this work
Trend in sales is rising / slower than we expected
SNY started notification period
Developing new marketing strategy - can pursue new partnerships, are free to initiate and negotiate discussions - in infancy (2 new things)
TS is the platform underlying lead program - expect to partner that technology, quiet ends today - will discuss programs today
MNKD is here to stay - cash to last to 2nd half of year - burn rate dropping rapidly
Al Mann remains chairman of board
Have appointed principal accounting officer to handle CFO's former day to day operations - Matt retains external financing responsibilities
Think we know how to increase sales - need to reduce price - SNY decided to price above parity
How to market product - key to success is not 2,000's sales force approach - need to educate doctors, get exposure to user experience information - social media - twitter account is active
Patient retention is not what we thought it would be
Fulfillment strategy - not discussing today
International strategy - distribution discussions are reopened (low margin, high volumes) - will help volumes and margins
SNY idea - user to user, doctor to user interactions - intend to ramp up
Specialized diabetes care centers - does not require MNKD capital, only participation - MNKD would lend Afrezza name - pilot facilities opening in next month or two - under supervision of endocrinologist, but not necessarily seeing endo at visit
TS pipeline - licensing - not huge upfront dollars, very close to one - thought we might have one today - milestones are quite near term - more emphasis on this in future
Ray Urbankski - initial list of candidates (12? on slide) - PK of these candidates parallels Afrezza
Treprostinil (PAH) Phase 1 at end of 3Q 2016? - partner 2Q through 4Q?
Palonosetron (chemo nausea) Phase 1 at 3Q 2017? - partner 3Q through 2Q 2017?
Epinephrine Phase 1 at 4Q 2017? - partner 3Q through 2Q 2017?
Back to Matt..
Execute Afrezza strategy to build market momentum - potential fundraising efforts in 2016 as needed.
Sale of facility, liquidate non-core assets
Suggesting SNY could provide $$ in disolving partnership
Additional call prior to next earnings call?
Other partnering opportunites that are innovative - MNKD to market Afrezza for time being, emphasis on removing cost obstacle, leading to improved coverage
Rapid expansion into selected internationals
Negotiating purchasing obligations
MNKD not going away...

Q&A
Q. SNY couldn't do - how can MNKD?
A. We thought the pricing strategy needed to be addressed; reimbursement issue, coverage was different from expectation; can live with tier 3 - PAs make it very difficult - reviews suggest it was amazing how difficult to obtain.
Why did some patients have success and others not, SNY early work validated that some patients did not receive expected results because of dosing / usage issues, being too conservative, patients were not go through titration period, quite after short time. CGM patients experienced excellent results, can do titration quickly. Advisory board in S.D. - endo tried once and didn't continue - excited following advisory board and second attempt - rapid control - fear of rapid decresae was reduced.
Ray - SNY devised Afrezza strategy within context of entire portfolio. Constraint that MNKD does not have.
Q. Strategic shift - price wasn't only impediment - what about spirometry.
A. SNY was tracking spirometry issue closely - spirometry was not as big an issue as reported
Q. How big a sales force will we employ?
A. Can't answer size of SNY sales force (not allowed) - can't answer second part (haven't determined) - employing consultants to help devise strategy. Intend to employ more modern sales strategy.
Ray - Rep / doc paradigm may not be way to go. Patient / doc education will be emphasized. Cannot afford large sales force - wouldn't employ anyway.
Q. Something must support the product. How does burn rate not accelerate as you add a salesforce?
A. Not going to commit to salesforce strategy at present. Immediate emphasis on implementing other strategy while ramping up - will end up with lower salesforce. Expect to offset expansions in sales force with reductions in other areas.
Q. FDA limitations on social media, user reports, etc.
A. Intend to be compliant. Increase in transperancy.
Q. Deerfield
A. Owe $80M cash - $5M payment due this summer. Next amount due in 2017. Good relationship with Deerfield - in conversations - not much more to say about that.
Q. Facility for sale
A. Is listed - $23M? Have offers. Incremental cash is more important that previously. Time needed to show progress.
Q. How long a leash does Afrezza have at this time? When would you pivot to TS?
A. Can only emphasize that Afrezza is amazing product - personal mission in life to ensure that Afrezza continues. Will sell if necessary.
Q. Approaching potential partners
A. Were talking with other parties besides SNY at time of deal. Have initiated process with other contacts. Cannot be more specific.
Q. Have considered royalty based pharma? Fixed royalty for product.
A. Yes - not necessarily optimal, but have considered, would be prudent.
Q. FDA mandated post-marketing safety study - timeline for compliance
A. Timeline for completion, not for initiation. Cost in flux due to negotiation with FDA on trial design. May be able to keep cost in control - expect costs to begin hitting books in late 2017.
Pediatric studies - are SNY studies - MNKD has access - will be presenting data from some at ADA in June - suggest studies were successful
Q. Cash guidance - does that include restricted cash in Deerfield loan
A. Yes
Q. Are you able to raise additional capital in Israel
A. Yes - not anxious to do that at this juncture. Folks are anxious to buy at this point, but we are not anxious to sell. Intend to turn ship around before taking that step.

[ricguy]

I agree as well I thought Matt did a pretty good job, great job Matt! Let's execute now!

[alethea]

Wow.  This was better than my wildest dreams.  THAT is the way a conference call should be handled.  I thought MNKD was toast.  But I think now they have a real shot at success.  Us investors may yet have something positive to see (at least from this point forward).  At least now I have some Hope!

Really good job Matt and Ray!!!!!!!!!!!!


That is by far and away the most impressive call I have heard from MNKD.

[lakemann]

And no more hide and seek,,, open communication from now on,, great news

[lakemann]

Great job Matt and Ray ,,, I raise my glass of kool-ade to ya!!!!!

[lynn]

I feel a heck of a lot better today than I did yesterday ! I was happy to hear that the code of Silence has been lifted & that he wants to hold a separate CC in the near future for Shareholders .

From some of the things he said today it seems like he may have received some of his ideas from this board such as persuing SM & opening Diabetes clinics ,) Over all I was happy with the call & it was refreshing to hear Matt today vs the CC after the Sanofi bomb was dropped . He was enthusiastic & I also think Ray did a fine job

Though I haven't convinced myself to buy more just yet I nolonger feel like I want to avoid running into the people that I told about this stock ,)

Lynn

[factspls88]

Thanks dudley and james.  Good stuff!

[dudley]

While the road forward is certainly filled with challenges I have to say my sense of despair since last Tuesday when the Sanofi bombshell hit has evaporated. It sounds like they have identified the key issues very clearly and have very realistic and tangible plans to deal with it. Not out of the woods completely but the ideas are good and if they can demonstrate consistent US script growth and get a couple of international deals going to me that is the signal the momentum will finally take over on it's own. I'm in for the long haul now for sure - it feels like there is a real sense of purpose and commitment that we have never seen before. The product has always spoken for itself, now the company seems to be stepping up to the task of delivering the promise. Probably sleep better tonight than I have for the last week - I don't feel like I am waking up tomorrow afraid to look at my stock quotes.

[mnholdem]

I found myself wondering about the TS pain medication that was previously in the pipeline and was missing from today's presentation. Is that possibly related to the TS partnership announcement that is allegedly days away? 

[Deleted]

Jan 13, 2016 20:34:34 GMT -5 mnholdem said:

I found myself wondering about the TS pain medication that was previously in the pipeline and was missing from today's presentation. Is that possibly related to the TS partnership announcement that is allegedly days away? 

i believe so too.. No way that they would miss it.... Waiting for wrap up and then disclose i think

[bthomas55ep]

Jan 13, 2016 20:34:34 GMT -5 mnholdem said:

I found myself wondering about the TS pain medication that was previously in the pipeline and was missing from today's presentation. Is that possibly related to the TS partnership announcement that is allegedly days away? 

Yes. I was thinking the same thing. All this migraine patent activity flying around and then not one mention. Must be able to determine the partner if medication revealed? It sure would be nice to see a T/S deal announced in the next couple weeks. Maybe.....

[james]

Yes - pain not being included in the top 3 candidates presented was striking. We knew PAH was close, but you have to think pain should be top of list.

[esstan2001]

Jan 13, 2016 20:34:34 GMT -5 mnholdem said:

I found myself wondering about the TS pain medication that was previously in the pipeline and was missing from today's presentation. Is that possibly related to the TS partnership announcement that is allegedly days away? 

That to me was the only logical conclusion... guess we will soon find out