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Post by prcgorman2 on Aug 22, 2024 12:02:00 GMT -5
Been thinking more about the predicament Boehringer Ingelheim will be in if the MNKD-201 (Nintedanib) phase 1 data readout is very positive. Ofev is the 2nd largest source of revenue for B-I behind Jardiance. Nintedanib DPI would be a direct competitor to Ofev.
MannKind presented a slide in the 1Q EC that forecast >$7.5B in 2030 revenue for Ofev and the existing minor competitor product (Esbriet) with Ofev presumably accounting 90% of the revenue.
With that kind of revenue at risk, B-I has to be developing a strategy on how to maintain that revenue leadership.
I think there are 3 general strategies that can be considered:
1) B-I offers a partnership with MannKind to develop Ofev DPI 2) B-I offers a buyout of MNKD (this is the homage to Kevinmik) 3) B-I delays sales of nintedanib DPI using patent infringement lawsuits
Patent infringement lawsuits could be part of the approach, but it doesn't look very likely to succeed. There isn't any question the forms are significantly different (inhalable vs. oral) and the nintedanib compound patent expires in 2026. This strategy isn't about preventing sales of nintedanib DPI but only delaying them. The value of the revenue acquired during the delay would be worth the cost of the legal delay tactics. e.g., UTHR suing LQDA over Yutrepia.
A partnership is a real possibility, but MannKind is no longer in the dire situation they were in when United Therapeutics offered a partnership after the successful Phase 1 trial of treprostinil DPI (nka Tyvaso DPI). That means MannKind is in a good position with respect to B-I and nintedanib DPI to negotiate far better short-term development investment and long-term royalties. (In another post I suggested $500M up front and 30% royalties, but I've no idea whether that upfront cost is reasonable.)
Finally, B-I could consider a buyout of MNKD. B-I has been reasonably active in the M&A space with 15 acquisitions since 1997 with 8 of the 15 in the last 4 years. Most of the acquisition amounts aren't disclosed but the publicly disclosed amounts total more than $12B. B-I could conceivably offer a buyout valuation of $3B. That's about 2x the current market cap and within the believable range of an offer. Would the board and institutional investors go for it? No idea. I personally hope not.
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Post by casualinvestor on Aug 22, 2024 13:02:18 GMT -5
Assuming better efficacy and less side effects (we won't see this until after a phase 3 trial though):
I think that going it alone would be a rough road. 201 will likely not be approved by patent expiration mid-2026, and that's without any legal challenges. But nintedanib oral formulation can go generic by 2029. That's a small window.
Up front/milestone payments would be proportional to the expense of doing the development work (including trials) and manufacturing setup. No clue about this amount, but 30% royalties sound pretty high? But if BI can convert their current patients to 201, it's the kind of thing that would protect them from oral generics. At least until someone else develops inhaled nintedanib
The likelyhood of a complete BI buyout looks very low. I say this as an investor that would take 2x buyout in a heartbeat
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Post by ktim on Aug 22, 2024 13:56:32 GMT -5
Assuming better efficacy and less side effects (we won't see this until after a phase 3 trial though): I think that going it alone would be a rough road. 201 will likely not be approved by patent expiration mid-2026, and that's without any legal challenges. But nintedanib oral formulation can go generic by 2029. That's a small window. Up front/milestone payments would be proportional to the expense of doing the development work (including trials) and manufacturing setup. No clue about this amount, but 30% royalties sound pretty high? But if BI can convert their current patients to 201, it's the kind of thing that would protect them from oral generics. At least until someone else develops inhaled nintedanib The likelyhood of a complete BI buyout looks very low. I say this as an investor that would take 2x buyout in a heartbeat Won't side effects be reported as part of Phase 1? |
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Post by porkini on Aug 22, 2024 14:02:58 GMT -5
We don't have a member "kevinmik" here, so I don't feel it necessary to "honor kevinmik," whoever that is.
Maybe this thread should be retitled?
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Post by prcgorman2 on Aug 22, 2024 14:16:57 GMT -5
We don't have a member "kevinmik" here, so I don't feel it necessary to "honor kevinmik," whoever that is. Maybe this thread should be retitled? kevinmik might be here, but you wouldn’t know unless you knew who the real kevinmik was and what their name was here. I chose the thread name because of recent posts which mentioned kevinmik that currently posts on ST and may be the same poster using that name that used to post on Yahoo! message board and incessantly offered reasons why a MNKD buyout was always just around the corner. I don’t know how to change the thread title, but if you can and want to, feel free. I suggest “Is a MNKD buyout likely?” |
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Post by porkini on Aug 22, 2024 14:48:16 GMT -5
prcgorman2, thanks for the suggested thread title. I did a search of members here before my previous post and "kevinmik" is a mythical creature on this board.
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Post by prcgorman2 on Aug 22, 2024 16:04:59 GMT -5
prcgorman2 , thanks for the suggested thread title. I did a search of members here before my previous post and "kevinmik" is a mythical creature on this board. We're all mythical creatures on this board unless we volunteer who we are (and even that can be questionable) or are doxed. i.e., Kevinmik on Yahoo! could be peppy on Proboards. I doubt that would be the case, but there isn't anything that prevents it. |
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Post by cretin11 on Aug 22, 2024 19:15:29 GMT -5
kevinmik definitely is not posting on ProBoards. Trust me, we’d know if he was 😜
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Post by casualinvestor on Aug 22, 2024 20:47:57 GMT -5
Assuming better efficacy and less side effects (we won't see this until after a phase 3 trial though): I think that going it alone would be a rough road. 201 will likely not be approved by patent expiration mid-2026, and that's without any legal challenges. But nintedanib oral formulation can go generic by 2029. That's a small window. Up front/milestone payments would be proportional to the expense of doing the development work (including trials) and manufacturing setup. No clue about this amount, but 30% royalties sound pretty high? But if BI can convert their current patients to 201, it's the kind of thing that would protect them from oral generics. At least until someone else develops inhaled nintedanib The likelyhood of a complete BI buyout looks very low. I say this as an investor that would take 2x buyout in a heartbeat Won't side effects be reported as part of Phase 1? Yes, but with lower efficacy than oral (nobody is really expecting that) it's a non-starter. Even if there were agreement with milestones after phase 1, that's the kind of thing that would cancel the deal. Also, since this is a life-saving drug I get the feeling that side effects are a secondary consideration unless they get really bad. |
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Post by Clement on Aug 23, 2024 6:08:07 GMT -5
Re: BI partnership after good Ph 1 results
Upfront payment would be proportional to present value of future sales. In this case, that could be huge.
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Post by thekid2499 on Aug 23, 2024 7:13:35 GMT -5
Re: BI partnership after good Ph 1 results Upfront payment would be proportional to present value of future sales. In this case, that could be huge. To me, this one seems like a no brainer on both sides so I'm going to say partnership is the most likely if the Phase 1 readout is good. BI will need to replace revenue of their oral version and they are experts in this space. I know partnership caps some upside, but I'm good not fighting big pharma when it doesn't make sense. An easier road to revenue with a partner who are experts in the space - sign me up. |
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Post by prcgorman2 on Aug 23, 2024 7:49:09 GMT -5
Re: BI partnership after good Ph 1 results Upfront payment would be proportional to present value of future sales. In this case, that could be huge. This makes a great deal of sense to me. Kind of front running future royalties if I understand you correctly. I don’t remember who wrote the post that suggested a more common royalty percentage for companies in a position to bargain is 30% as compared to the 10% that MannKind agreed to for Tyvaso DPI. I would love to have that confirmed or corrected. Can you estimate the upfront payment on PV of future sales? Or does anybody know of examples we could review to draw from? |
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Post by sportsrancho on Aug 24, 2024 6:45:19 GMT -5
prcgorman2 , thanks for the suggested thread title. I did a search of members here before my previous post and "kevinmik" is a mythical creature on this board. We're all mythical creatures on this board unless we volunteer who we are (and even that can be questionable) or are doxed. i.e., Kevinmik on Yahoo! could be peppy on Proboards. I doubt that would be the case, but there isn't anything that prevents it. Ha….not me:-) |
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Post by sportsrancho on Aug 24, 2024 7:00:52 GMT -5
To add to that Kevin is a real person, lives in New York City, and has been to shareholder meetings, and I know people that have met Peppy. I believe she lives in Minnesota:-)
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Post by parrerob on Aug 24, 2024 7:23:50 GMT -5
Personally I like Kevin posts (not at all but quite the most).... following him since 2014 on yahoo finance.
Some times his posts are very informative.
I like Peppy too... and like her posts specially on TA....
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