What's Going On - Nonspecific MNKD Topics

[casualinvestor]

The way the article lays that out, it makes me think that nintedanib DPI would be the second optional drug that was part of the original UTHR agreement. From way back in 2018:

In addition, MannKind granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each optioned product would be subject to the payment to MannKind of up to $40 million in additional option exercise and development milestone payments as well as a low double-digit royalty on net sales of any such product

This has probably been discussed here before, but guessing the timing might be interesting.

T-DPI collaboration was announced 9/2018, and the phase 1 BREEZE safety trial didn't actually start until 9/2019. However, MNKD was in real trouble, so that may have moved up the announcement and cash infusion earlier that it would have been with a financially health MNKD (like we have now). IF nintedanib DPI is going to be for UTHR, when would this actually get announced? There are plenty of possible answers for that. Maybe never. Maybe not until the phase 1 looks good. Maybe this gets slowly developed if T-DPI gets great results when used against IPF, so no announcement until after TETON trials and timing decisions get made?

$40M plus milestones similar to T-DPI would be a steal to have MNKD develop nintedanib DPI

[prcgorman2]

I’ve wondered if nintedanib was the 2nd molecule too, but not sure why there would be any secrecy about it. Would you agree to such a crappy deal as $40M dev and low double-digit royalties? I mean, you might given where MannKind was when they made the Tyvaso DPI deal, but they stopped talking about the 2nd molecule quite some time ago.  I’ll need to go back to listen to the 1Q earnings call (if it’s still available), but I know Mike got asked about partnership versus go-it-alone, and it might have been clofazimine but I don’t think so. MannKind is already in the driver’s seat on clofazimine, and it’s not the kind of opportunity that nintedanib is where partnership is a much more important consideration because of the 2 other larger BPs whose revenue is at risk.  If nintedanib is the 2nd molecule, I have even more respect for UTHR.  And, it will be good for MNKD, but not as good as if nintedanib is not the 2nd molecule.

[casualinvestor]

Q1 2024 Transcript

Hey, this is Gugen on for Olivia. Congrats on a great earnings. I just wanted to ask about your IPF program. As that moves into the clinic, how are you guys thinking about the path forward for MNKD-201? And have you considered potentially working with a partner there just considering how much interest there is in that market?

Michael Castagna -- Chief Executive Officer

Yes. I think I'd say the same thing, Gugen, is that IPF obviously is a challenging disease for lots of reasons and lots of failures. We've been working on the INHALE detention program for many years, and it's at that stage now where it's just about execution, meaning we feel pretty good about the dose. We'll confirm that in our Phase 1 around tolerability, but now it's just moving these patients in and getting the results.

And we feel that means if all works out, we should have a clear winner that can help a lot of people and deal with the No. 1 Achilles' heel of the market leader out there. And so if you think about a $3.9 billion drug that's almost $100 million a week out the door in revenue, would I much rather have that for our shareholders versus a partner? I don't think in these diseases, you need a ton of infrastructure that we haven't already built. Meaning specialty support services, pharmacy distribution, wholesalers, patient trainings, and things like that, we have all that.

And so it's really about scaling that up and providing the best quality service as possible for patients and providers. And so that's directionally where we're planning ahead. We think, financially, we can afford to make these trials go forward, and I think the data is going to drive those decisions as we get there. If you come to the ex U.S. market, I think we'll continue to reassess those in terms of the go-through distributors or as their partners. But I think from our perspective in the U.S., we continue to progress independently.

The conversation was definitely about nintedanib. Hopefully they can just do a combined phase 2/3 trial after the phase 1 since the drug is already approved for treating IPF. Dosing does need to be established

[Clement]

Is nintedanib the 2nd molecule? Maybe it could have been.
Most legal agreements have a time limit. I'm guessing that the time limit (2018 agreement) for UTHR to commit on nintedanib has already passed and Mike says we now go-it-alone.

[casualinvestor]

Good thing I read a little further up. It looks like UT passed on MNKD-201?

We have been so focused on Tyvaso over the years and that we've had different ideas. For example, we brought public sales in imatinib. Both of those would have had to have been in-licensed by UT at this stage. We got them to -- because they have exclusivity for our platform, for PH, and so we couldn't move forward with them without them bringing them in.

They chose not to, and I defer to them. But I think the biggest thing at the time we had that discussion was really around Tyvasa was going to be so big that these other things are going to move the needle, and that turned out to be true when you look back in time. So I think it's really trying to find what's next that's going to be meaningful clinically. But at the end of the day, we are moving forward in other orphan diseases outside of PH by ourselves.

So Clofazimine will likely be a Mannkind solo project. IMO the jury is still out on whether MNKD goes it alone with nintedanib-DPI.

[Clement]

Aug 1, 2024 9:11:08 GMT -5 casualinvestor said:

Good thing I read a little further up. It looks like UT passed on MNKD-201?

We have been so focused on Tyvaso over the years and that we've had different ideas. For example, we brought public sales in imatinib. Both of those would have had to have been in-licensed by UT at this stage. We got them to -- because they have exclusivity for our platform, for PH, and so we couldn't move forward with them without them bringing them in.

They chose not to, and I defer to them. But I think the biggest thing at the time we had that discussion was really around Tyvasa was going to be so big that these other things are going to move the needle, and that turned out to be true when you look back in time. So I think it's really trying to find what's next that's going to be meaningful clinically. But at the end of the day, we are moving forward in other orphan diseases outside of PH by ourselves.

So Clofazimine will likely be a Mannkind solo project. IMO the jury is still out on whether MNKD goes it alone with nintedanib-DPI.

A lot of patients with IPF have PH.
So, is nintedanib for IPF "outside of PH"?

[prcgorman2]

Aug 1, 2024 9:43:17 GMT -5 Clement said:

Aug 1, 2024 9:11:08 GMT -5 casualinvestor said:

Good thing I read a little further up. It looks like UT passed on MNKD-201?
So Clofazimine will likely be a Mannkind solo project. IMO the jury is still out on whether MNKD goes it alone with nintedanib-DPI.

A lot of patients with IPF have PH.
So, is nintedanib for IPF "outside of PH"?

Listened again today.  I think the bullseye is squarely on the IPF market treated by Ofev.  Fingers crossed for a good Phase 1 result (and early pre-trial indications are that's very possible).  The market estimate was $7.5B for Ofev and Esbriet in 2030 and the lion's share was Ofev.  Current market is over $4B pushing "$100M a week".

[Thundersnow]

Aug 1, 2024 9:11:08 GMT -5 casualinvestor said:

Good thing I read a little further up. It looks like UT passed on MNKD-201?

We have been so focused on Tyvaso over the years and that we've had different ideas. For example, we brought public sales in imatinib. Both of those would have had to have been in-licensed by UT at this stage. We got them to -- because they have exclusivity for our platform, for PH, and so we couldn't move forward with them without them bringing them in.

They chose not to, and I defer to them. But I think the biggest thing at the time we had that discussion was really around Tyvasa was going to be so big that these other things are going to move the needle, and that turned out to be true when you look back in time. So I think it's really trying to find what's next that's going to be meaningful clinically. But at the end of the day, we are moving forward in other orphan diseases outside of PH by ourselves.

So Clofazimine will likely be a Mannkind solo project. IMO the jury is still out on whether MNKD goes it alone with nintedanib-DPI.

My gut is telling me MNKD will partner with UTHR on 201 after the phase 1 is complete.  I feel this is the 2nd Molecule and pretty sure they will modify the agreement (if it's still intact).  There is a possibility a new agreement will be negotiated which could be a reason why Steve Binder is still onboard.   IMO there's a possibility Binder could stay on after years end as a special advisor to Mike.   That would be an excellent move. 

[BD]

Jul 21, 2024 17:22:54 GMT -5 mayday said:

Jul 21, 2024 16:11:06 GMT -5 BD said:

Absent crystal ball, I'm with choppy.

I will not let you forget that. lol.

Don't worry, I haven't forgotten

[ktim]

Imaginations seem to be fueled by drops in share price.

Are we being bought out or another licensing deal... two possibilities so 50/50 odds on either it has to be one of them, right Ooops... too early for math.

[prcgorman2]

Aug 1, 2024 11:27:06 GMT -5 Thundersnow said:

Aug 1, 2024 9:11:08 GMT -5 casualinvestor said:

Good thing I read a little further up. It looks like UT passed on MNKD-201?
So Clofazimine will likely be a Mannkind solo project. IMO the jury is still out on whether MNKD goes it alone with nintedanib-DPI.

My gut is telling me MNKD will partner with UTHR on 201 after the phase 1 is complete.  I feel this is the 2nd Molecule and pretty sure they will modify the agreement (if it's still intact).  There is a possibility a new agreement will be negotiated which could be a reason why Steve Binder is still onboard.   IMO there's a possibility Binder could stay on after years end as a special advisor to Mike.   That would be an excellent move. 

Because UTHR gave it a pass, I am not as sure as you, but UTHR partnering, or B-I are both possible, and of course the 3rd possibility, MannKind going it alone is not just a possibility but the stated path "directionally" speaking.

It's a beautiful situation to be in.  Assuming a successful Phase 1 trial (and there's good reason to have hope for that), MannKind is in the catbird seat: there will be no bad option for going to market.

[mayday]

Aug 2, 2024 8:48:28 GMT -5 BD said:

Jul 21, 2024 17:22:54 GMT -5 mayday said:

I will not let you forget that. lol.

Don't worry, I haven't forgotten

touché

[prcgorman2]

Looking forward to tomorrow's news. Let's hope the market continues the rebound.

[castlerockchris]

Dylan Ratigan (former CNBC host who became famous from his 2008 banking crisis rant) hosts a program on YouTube called Bootstrapping and today his guest was Lauren Bongiorno from Riley Health. It was a very interesting conversation about coaching people with Type 1. Ridley Health is a healthcare group that coaches people with T1. They have a list of 42 factors that they coach on. She claimed that less than 21% of Type 1s have an A1c below 7 and they are able to triple that number with their patients. Amazingly, only 2 insurance companies cover their coaching and even at that they cover less than 50% of the cost of the program. If Riley achieves the results she claims, I find it utterly ridiculous that insurance companies wouldn't be beating a path to their door as it would save them money in the long run. I guess what insurance companies are saying is they have no way of quantifying how much they won't payout in benefits if 2x the number of people on their plans with Type 1 consistently had an A1c below 7. I constantly wonder when will our healthcare model move away from favoring treatment and start working toward prevention? Sounds like a VDEX type approach, without the doctors or focus no medication. She really underscored what we on this board already know, which is T-1s do not get the education they really need from the current healthcare system to combat this disease.

Also of note is that only once during the entire program did she mention medicating with insulin, which surprised me. I would bet dollars to donuts Riley probably knows very little about Afrezza. 

For those interested in watching here is the link - www.tastylive.com/episodes/240809_bootstrapping-with-dylan-ratigan-- (Corrected the link to be just this episode)


Their Website is Risleyheath.com

[ktim]

Aug 9, 2024 16:16:59 GMT -5 castlerockchris said:

Dylan Ratigan hosts a program called Bootstrapping and today his guest was Lauren Bongiorno from Riley Health. It was a very interesting conversation about coaching people with Type 1. Ridley Health is a healthcare group that coaches people with T1. They have a list of 42 factors that they coach on. She claimed that less than 21% of Type 1s have an A1c below 7 and they are able to triple that number with their patients. Amazingly only 2 insurance companies cover their coaching and even at that they cover less than 50% of the cost of the program. If they get the results they say, I find it terribly ridiculous that insurance companies wouldn't be beating a path to their door as it would save them money in the long run. I guess what insurance companies are saying is they have no way of quantifying how much they won't payout in benefits if 2x the number of people on their plans with Type 1 consistently had an A1c below 7. Again when will our healthcare model move away from favoring treatment and start working toward prevention? Sounds like a VDEX type approach, without the doctors or focus no medication. She really underscored what we on this board already know, which is T-1s do not get the education they really need to combat this disease.

Also of note is that only once during the entire program did she mention medicating with insulin, which surprised me.

For those interested in watching here is the link - www.youtube.com/live/_BGyux5iAsQ?si=n4rHuNRwwzqs13yz

Their Website is Risleyheath.com

I'm no expert on healthcare industry, but I suspect one or both of these two factors contribute to why prevention isn't more of a focus than it is.

1) Profits in insurance industry, be it casualty or health, are basically proportional to covered costs/losses.  Unexpected costs can reduce profits on a short term basis, but overall the premiums are set to give a certain profit margin on the underlying payouts... the higher the payouts for medical care, the more insurers make.   Though they do start losing when the premiums get so high people go without coverage.

2) People switch insurance a lot, so doing something that reduces costs for a patient years out often doesn't accrue to the benefit of the insurer doing the early investment in prevention.  When young, people have insurance in the commercial markets and then when old enough that the cost burdens of comorbidities really kick in they are covered under Medicare.