Call synopsis

[dudley]

Unequivocal Afrezza support, Technosphere key platform going forward

Mannkind 2.0 : strong sense of urgency, focus on execution, clear communication.  EXTREMELY limited on what they can disseminate on Twitter etc. due to FDA limitations.

Sanofi transfer:  Teams have met , April 5th set as tentative transition date but may request later date - much is out of their direct control. Sanofi retains ALL rights until transfer just as it has been. MNKD will NOT promote Afrezza and is unable to make ANY SDA filings while Sanofi retains control. 

Clinical studies : both studies very positive and data will be presented at ADA meeting.  Pediatric study is underway and will transfer back to MNKD

Discussions with potential partners ongoing but MNKD will also market themselves - looking for seasoned marketing exec.  MNKD will NOT release exclusive rights again, any partner will be a co-partner.

Care centers operated by a separate company, first should be opened in New Jersey later this Q.  Onsite training - spirometry, product usage etc.

Afrezza advisory council still being formed.

International - priority for regions accepting US approval and multiple discussions underway.

RLS - wholly owned and independent, unaffiliated with AL.  MNKD retains all rights.. Andrea Leone Bay move not co-ordinated with MNKD but Matt speaks highly of her since they thought she was very valuable.

Ray Urbanski : oral inhalation technology versatile drug delivery platform.  Pretty much rehash, nothing overall new.  Hypertension $10 Billion market soon.  Tripostinil early phases.

Palinositron for chemo induced nausea growing to $1.88 Billion pre-clinical Q3 2016  - Clinical trials 2017.  Epinephrine market over $1 Billion, large injectors lead to hesitation of usage and inhaler sb superior for results.  Preclinical later in 2016,  clinical trials 2017

Patent portfolio massive (I lost count Ray was rattling them off so fast)  over 600 patents pending.

Renegotiating purchase commitments and numerous other "runway extensions"  BK is last resort and not under consideration currently.

NASDAQ delisting:  Closing over $1 resets the clock - even one day (so NEW 30-day clock starts today).  Has to close under $1 for 30 consecutive days before you get a letter. 

Lawyers are just a fact of life, insurance covers.

SEC investigation underway regarding stock manipulation!  MNKD has had discussions with SEC and have some tools of their own that may help.

MNKD will pick up ongoing costs for trials - pediatric is fairly small this year and safety wasn't scheduled until later this year.

Costs with Sanofi should be similar to what they have been, maybe somewhat lower until transition complete.




This gets most of it - all in all not a dramatic change from JP Morgan.

[esstan2001]

nicely done. Synopsis that is

[mnholdem]

Agreed. Thanks!

[james]

Thanks Dudley, very much echos my own notes. I thought the continued statement of care centers opening by end of 1Q was the strongest point. Also, continuing to discuss international as a priority is a key. Matt left a little nugget to chew on about the test data to be revealed at ADA - but I don't expect anything out of that.

Certainly left uneasy about how they will continue funding operations past summer. There is currently around a 3-4 month window between getting Afrezza rights back and running out of cash on hand. Something must be done on an Afrezza partnership in that window, or loan emerge, or a settlement with Sanofi, etc. since another TS deal seems a ways off.

[Chris-C]

Thanks Dudley! Does anyone know whether the clinics can start before the marketing rights are transferred from SNY? End of quarter timeline would suggest so.

[kball]

Also, Matt thanked us! (retail investors)

[rvc]

good luck getting that seasoned marketing exec. Kind of a hard sell when the company is potentially a few quarters from bankruptcy 

[bioexec25]

Thought a pilot in Jersey was schedule to start this month (Feb).

[ishorr]

Yahoo board had Matt saying something like: AT THIS POINT WE ARE NOT CONSIDERING BANKRUPTCY
Did you hear anything like that?

[od]

I had to take a call as Matt started to speak about the Care Centers; any color is appreciated. (The archived site is not yet available).  Thanks.

[seanismorris]

Good summary. The call was mostly positive and helpful.

I find it interesting that the Shoutbox was so negative.

The two main negative items:
1. TS pain is apparently on the backburner (though I'm not surprised because of cost)
2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected).

The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while.

The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders.

I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward.  The first partner is likely an international Afrezza partner, but Sanofi needs to go away first.

[nemzter]

Feb 3, 2016 17:58:53 GMT -5 Chris-C said:

Thanks Dudley! Does anyone know whether the clinics can start before the marketing rights are transferred from SNY? End of quarter timeline would suggest so.

I was wondering this as well, can't SNY stop any efforts associated with 'A until the deal ends in April?

Also, would the clinics offer up different options for the basal insulins... hmm

[nylefty]

The only real news from the CC was that Receptor is an established company that's changed its name. I'm waiting for somebody to leak that name.

[od]

Feb 3, 2016 18:03:55 GMT -5 nemzter said:

Feb 3, 2016 17:58:53 GMT -5 Chris-C said:

Thanks Dudley! Does anyone know whether the clinics can start before the marketing rights are transferred from SNY? End of quarter timeline would suggest so.

I was wondering this as well, can't SNY stop any efforts associated with 'A until the deal ends in April?

Also, would the clinics offer up different options for the basal insulins... hmm

To be regulatory compliant, the centers will need to offer all therapies for diabetes.

[peppy]

Feb 3, 2016 17:46:28 GMT -5 dudley said:

Unequivocal Afrezza support, Technosphere key platform going forward

Mannkind 2.0 : strong sense of urgency, focus on execution, clear communication.  EXTREMELY limited on what they can disseminate on Twitter etc. due to FDA limitations.

Sanofi transfer:  Teams have met , April 5th set as tentative transition date but may request later date - much is out of their direct control. Sanofi retains ALL rights until transfer just as it has been. MNKD will NOT promote Afrezza and is unable to make ANY SDA filings while Sanofi retains control. 

Clinical studies : both studies very positive and data will be presented at ADA meeting.  Pediatric study is underway and will transfer back to MNKD

Discussions with potential partners ongoing but MNKD will also market themselves - looking for seasoned marketing exec.  MNKD will NOT release exclusive rights again, any partner will be a co-partner.

Care centers operated by a separate company, first should be opened in New Jersey later this Q.  Onsite training - spirometry, product usage etc.

Afrezza advisory council still being formed.

International - priority for regions accepting US approval and multiple discussions underway.

RLS - wholly owned and independent, unaffiliated with AL.  MNKD retains all rights.. Andrea Leone Bay move not co-ordinated with MNKD but Matt speaks highly of her since they thought she was very valuable.

Ray Urbanski : oral inhalation technology versatile drug delivery platform.  Pretty much rehash, nothing overall new.  Hypertension $10 Billion market soon.  Tripostinil early phases.

Palinositron for chemo induced nausea growing to $1.88 Billion pre-clinical Q3 2016  - Clinical trials 2017.  Epinephrine market over $1 Billion, large injectors lead to hesitation of usage and inhaler sb superior for results.  Preclinical later in 2016,  clinical trials 2017

Patent portfolio massive (I lost count Ray was rattling them off so fast)  over 600 patents pending.

Renegotiating purchase commitments and numerous other "runway extensions"  BK is last resort and not under consideration currently.

NASDAQ delisting:  Closing over $1 resets the clock - even one day (so NEW 30-day clock starts today).  Has to close under $1 for 30 consecutive days before you get a letter. 

Lawyers are just a fact of life, insurance covers.

SEC investigation underway regarding stock manipulation!  MNKD has had discussions with SEC and have some tools of their own that may help.

MNKD will pick up ongoing costs for trials - pediatric is fairly small this year and safety wasn't scheduled until later this year.

Costs with Sanofi should be similar to what they have been, maybe somewhat lower until transition complete.




This gets most of it - all in all not a dramatic change from JP Morgan.

slides:

patents...    screencast.com/t/MKpIlv432a

epi...... screencast.com/t/Dn7tE9hxZPk

nausea...... screencast.com/t/CYVSv8ia5hJ8