2024 upcoming catalysts

[cppoly]

Per the Q2 presentation, here's the upcoming milestones in 2024:

1) INHALE-1 top line data readout
2) INHALE-3 30 week readout
3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results
4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites

Which has the most impact to share price?

[prcgorman2]

Good points and good question. You could create a thread with a poll using the exact same format to learn what votes readers would cast. If you’re just interested in a general discussion, that’s fine too.

I didn’t see anything in the Afrezza numbers from the last EC that suggests there was a sudden surge in prescriptions based on the presumed influential INHALE-3 symposium at the ADA conference. Based on that, I think #s 1 and 2 are still very important for the longer term potential of revenue from sales of Afrezza, but not important to the near term share price.

Because of the size of the market in terms of patients and revenue, I think #3 is more important than #4, but #4 is more likely to generate revenue sooner. That said, I continue to believe a succesful Phase 1 of nintedanib DPI (#3) will cause Boehringer-Ingelheim to approach MannKind about a partnership. Partnership seems interesting if B-I is willing to be generous in their upfront development investment and longer term royalties. If that would happen (guessing about a 50/50 chance or less), I am hopeful MannKind will consider the benefit of avoiding patent entanglements and cash infusion and royalties on their ability to invest in the next pipeline candidates and potentially subsidize Afrezza marketing. i.e., aggressively pursue insurance coverage and Afrezza price reductions while the INHALE-1, INHALE-3, and gestational diabetes trial “move the needle” with prescribers.

Analysts and institutional investors are more likely to have information to help them read the tea leaves, but I will guess #3 (nintedanib DPI) has the most potential to positively impact the share price in the near term.

[ktim]

I think reducing price of Afrezza (other than as part of formulary bargaining) would be counterproductive, and it would appear to be the opposite of what has been happening... and I don't think current agreements for RAAs are leaving options for Afrezza no matter what concessions on pricing offered or how aggressive MNKD is.

I doubt any of these news items would have large and lasting effect on share price. With MNKD pursuing inhalation delivery options for already proven molecules, a phase 1 study success would likely be the expected outcome, so less room for upside surprise... though perhaps with Nintedanib, the phase 1 might reveal improved side effect profile ?? Maybe that could result in upside potential. Of course if a third party jumped in that would be a share price mover, but that is getting into "hope" category rather than about the trial itself.

Hopefully we should continue to see the floor improve for MNKD share price as revenues and profits increase each quarter, and assuming we don't get a significant overall market correction.

EDIT:   Ooops, I had inserted three '?' after a question and it got converted into a grumpy looking emoji, which makes me

[prcgorman2]

I agree the formulary bargaining should be the main thrust of price reduction/discounts.

[Clement]

Aug 22, 2024 6:08:09 GMT -5 cppoly said:

Per the Q2 presentation, here's the upcoming milestones in 2024:

1) INHALE-1 top line data readout
2) INHALE-3 30 week readout
3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results
4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites

Which has the most impact to share price?

Thanks for the question.  It made me ask when and how much in $.  When --  I guess you mean in 2024.

I wanted to say INHALE-1, but the when is ADA in 2025, right?  We have been here before.  In Q4 2024, I suggest MNKD will announce "we have the data it looks good but we can't show it to you because we must save it for ADA."  

So now, I like prc's big IF.  IF means we get an offer from BI for OFEV-DPI by end of year  In 2024 -- is that even a possibility?

Alternately, I think the steady growth of MNKD of $ 6M per Q is  going to have the greatest impact in near-term.  Most of that 6M is due to T-DPI in PH-ILD.  UTHR now has a nice pathway forward in PH-ILD with no competition for 9 months.  And they are executing a plan to grow that market by indentifying patients with PH-ILD by right heart cath.  (Re: banner ads and Tempus)

Don't get me wrong.  I absolutely love the long term path for MNKD with PEDS, clofaz, and ninte.  But I also love the steady growth we have right now with T-DPI.

[cjm18]

Chat gpt says.

Among the four upcoming milestones for MannKind Corporation (MNKD) in 2024, the **INHALE-1 top-line data readout** is likely to have the most significant impact on the share price. This is because top-line data from a major clinical trial, particularly for a product in development, can significantly influence investor sentiment and the perceived future success of the company. Positive results could lead to substantial stock appreciation, while negative results might cause a decline.





Here's a ranking of the upcoming 2024 milestones for MannKind Corporation (MNKD) based on their potential impact on the share price:

1. **INHALE-1 Top Line Data Readout**: This is the most significant as it provides the first major clinical results, directly affecting the perceived success of the INHALE program.
2. **MNKD-201 (Nintedanib) Phase 1 Data Readout and Chronic Tox Results**: Early-phase data on a new drug can significantly influence investor outlook.
3. **INHALE-3 30 Week Readout**: Important for further validating the INHALE program, but secondary to INHALE-1.
4. **MNKD-101 (Clofazamine) ICoN-1 Trial Expansion**: Important, but more of a long-term impact compared to the immediate significance of the other milestones.

[agedhippie]

I would add INHALE-GDM to the list. It should increase the use of Afrezza to treat GDM, although it may need a larger trial to get insurance cover. Insurers may be more willing to cover Afrezza for GDM because it's usually a self-limiting condition.

[parrerob]

I would add as well Afrezza approval in India....
Even if it was not mentioned during last Earning Call, it is still present in the bi-annual report from CIPLA that was quite recently published (created July 26th, 2024).

www.cipla.com/sites/default/files/Annual-Report-2023-24-%28Double%20page%29.pdf

PAG 6: "Adding a niche set of innovative products like inhaled insulin, .... "
PAG 67: "We completed the inhaled insulin Phase 3 clinical trial and are awaiting its approval..."

Not expecting big revenues from India... but a nice catalyst as Afrezza needs to be international and Brasil was a bad start to be forgotten.



EDIT...

I noticed that after more than 10 years within this post I have become a "postaholic".... let's celebrate it and let's hope it turns out well.



I would prefer a post-alcoholic level       but aholic is fine too

[prcgorman2]

Cipla is still waiting for approval??? Hmmm, approved by the FDA after an Advisory Committee of experts basically over-ruled the FDA 10 years ago, and having more recently completed the Phase 3 trial in India several months ago. Why would it take so long to get approval?

[ktim]

The meaningful catalyst regarding Afrezza would be if there starts to be meaningful improvement in formulary coverage, which I think most are not expecting at this point.

The trials are unlikely to be anything surprising. Afrezza will work well in the general population and for GDM. And it will be approved in India. Outcomes inline with expectations usually aren't major catalysts.

Even ChatGPT realizes that "because top-line data from a major clinical trial, particularly for a product in development, can significantly influence investor sentiment and the perceived future success of the company."  And as we know, Afrezza is no longer in development.

For a post market study to have a large impact it needs to be designed to test for an important and new outcome... e.g. think the recent large/long trial from Lily for GLP-1 showing rather astounding reduction of progression to type 2 diabetes in the subject population.  Or previous studies where diabetes medications were shown to reduce CV risk.  Those sort of post market studies are way more expensive than the type MNKD is doing, which are basically to clean up some mistakes in previous similar trials.

Formulary coverage in US is the first, second and third most important thing.  Will be interesting if at some point Mike starts talking about that as a realistic goal... perhaps a goal that management's bonuses are tied to.

[parrerob]

Totally agree. But this thread is related to next catalysts near term event q3/q4 2024 that could move the SP.

Unfortunately no way insurance will be one of them....

Cipla starting selling Afrezza in India could and should be.

[parrerob]

Aug 26, 2024 12:37:55 GMT -5 prcgorman2 said:

Cipla is still waiting for approval??? Hmmm, approved by the FDA after an Advisory Committee of experts basically over-ruled the FDA 10 years ago, and having more recently completed the Phase 3 trial in India several months ago. Why would it take so long to get approval?

I don't know but MC in May told us that approval is expected in q4.

[ktim]

Aug 26, 2024 14:05:29 GMT -5 parrerob said:

Totally agree. But this thread is related to next catalysts near term event q3/q4 2024 that could move the SP.

Unfortunately no way insurance will be one of them....

Cipla starting selling Afrezza in India could and should be.

Why are you expecting start of sales in India to be a catalyst?

1) The amount of revenue compared to MNKD overall revenue (existing Afrezza plus Tyvaso) will be very small.

2) There is no reason to expect it will not be approved this year, so whatever small increase in rev is likely already largely priced in.

Don't get me wrong, things happening as expected is definitely a positive for MNKD.  I think share price is still suffering some from hangover effects from overpromise/underdeliver of the past.  All these small accomplishments coming up should help reduce the poorly managed company discount I believe we still have as a stock.

For the remainder of 2024 I suspect the overall market conditions will be the biggest factor in our share price.

[prcgorman2]

Aug 26, 2024 14:38:50 GMT -5 ktim said:

Aug 26, 2024 14:05:29 GMT -5 parrerob said:

Totally agree. But this thread is related to next catalysts near term event q3/q4 2024 that could move the SP.

Unfortunately no way insurance will be one of them....

Cipla starting selling Afrezza in India could and should be.

Why are you expecting start of sales in India to be a catalyst?

1) The amount of revenue compared to MNKD overall revenue (existing Afrezza plus Tyvaso) will be very small.

2) There is no reason to expect it will not be approved this year, so whatever small increase in rev is likely already largely priced in.

Don't get me wrong, things happening as expected is definitely a positive for MNKD.  I think share price is still suffering some from hangover effects from overpromise/underdeliver of the past.  All these small accomplishments coming up should help reduce the poorly managed company discount I believe we still have as a stock.

For the remainder of 2024 I suspect the overall market conditions will be the biggest factor in our share price.

Sales in India through Cipla is about reducing unit cost of Afrezza, but there's potential for India to be influential beyond its own borders if a substantial community of users can be established.

[ktim]

Tyvaso production has already had beneficial effect on COGS because expenses of personnel and facilities are now split across a much larger production base. While India might have served that purpose before Tyvaso, I wouldn't expect the impact of it to be large now since the amount of product shipped to India isn't likely to be significant when compared to the total production of Afrezza + Tyvaso.

Some incremental positive contribution, but I don't think it's going to jump out in the numbers.