SAGE
Sage Therapeutics, Inc
stock NASDAQ

I don't think the payments are all that meaningful. The information isn't public, or at least I'm not aware of it, but I estimate a small 1m payment for canadian approval, and then maybe a slight uptick in revenue if canadian sales do well. To my knowledge, Tlando isn't even up for approval yet in the other regions, so i'm not expecting much from the testosterone side.
Why no buyer? I think its because they are worth a lot more than their market cap and wouldn't want to sell for less than their worth. I do not know how other biopharmaceutical companies view Lipocine or what they might offer. If you want my speculation, and thats all I can do is speculate, here's what I look at.
Lipocine's lead asset is the PPD drug that is in this wierd spot from that outlier site. I compare it to the current standard of care, Zurzuvae, and see how they stack up against each other. Lipocines drug has a much shorter treatment duration, (48 hours vs 14 days), it had a better safety profile, the onset of action took hours instead of days, and the effect size measured by HAM-D reduction compared to placebo was larger (when you exclude the outlier site). For the actual numbers I would encourage you to review their corporate presentation,and that KOL event I referenced earlier. It can get technical and might be a lot to take in, but there is a lot of information there.
The Zurzuvae comparison is really valuable because Sage therapeutics was just bought out last summer by Supernus, and Sage owned 50% of Zurzuvae. SAGE didn't have much else in the pipeline after some of their other zuranolone indications didn't pan out, and Supernus laid off the vast majority of Sage's staff. I hate to see that, but it tells us Supernus was primarily buying Zurzuvae.
SAGE had hundreds of millions on their books, so you have to factor that into the buyout cost, but they also split all the Zurzuvae revenue wirh Biogen. So if 50% of Zurzuvae was worth in the neighborhood of $200m last summer (after removing their book value), then I have to think Lipocine, with what I believe is a superior drug, will be worth more at the end of the regulatory process.
They still have to execute, they need the funding to run any additional trials the FDA might require, they would nees to file the NDA which costs moneg, they don't have an in house commercialization staff, etc. There is always risk the trial results aren't as good the next time, or that they need significant dilution, or a safety problem comes up. Suffice to say, nothing is ever guaranteed, and I urge you to double check me.
There are a lot of unknowns, what will the FDA say is the path forward, how long will it take to get through those steps, how long will it take? I'm excited about it, but I've been invested in this company for years (flipping catalysts), and I'm really patient. Its definitely not for everyone, it depends on someone's risk tolerance, how long they are willing to wait, etc, etc.
Happy to share more dd if you have questions, but as stated before I'm just an amateur investor sharing my opinion, you should always follow up with your own research.

I don't think the payments are all that meaningful. The information isn't public, or at least I'm not aware of it, but I estimate a small 1m payment for canadian approval, and then maybe a slight uptick in revenue if canadian sales do well. To my knowledge, Tlando isn't even up for approval yet in the other regions, so i'm not expecting much from the testosterone side.
Why no buyer? I think its because they are worth a lot more than their market cap and wouldn't want to sell for less than their worth. I do not know how other biopharmaceutical companies view Lipocine or what they might offer. If you want my speculation, and thats all I can do is speculate, here's what I look at.
Lipocine's lead asset is the PPD drug that is in this wierd spot from that outlier site. I compare it to the current standard of care, Zurzuvae, and see how they stack up against each other. Lipocines drug has a much shorter treatment duration, (48 hours vs 14 days), it had a better safety profile, the onset of action took hours instead of days, and the effect size measured by HAM-D reduction compared to placebo was larger (when you exclude the outlier site). For the actual numbers I would encourage you to review their corporate presentation,and that KOL event I referenced earlier. It can get technical and might be a lot to take in, but there is a lot of information there.
The Zurzuvae comparison is really valuable because Sage therapeutics was just bought out last summer by Supernus, and Sage owned 50% of Zurzuvae. SAGE didn't have much else in the pipeline after some of their other zuranolone indications didn't pan out, and Supernus laid off the vast majority of Sage's staff. I hate to see that, but it tells us Supernus was primarily buying Zurzuvae.
SAGE had hundreds of millions on their books, so you have to factor that into the buyout cost, but they also split all the Zurzuvae revenue wirh Biogen. So if 50% of Zurzuvae was worth in the neighborhood of $200m last summer (after removing their book value), then I have to think Lipocine, with what I believe is a superior drug, will be worth more at the end of the regulatory process.
They still have to execute, they need the funding to run any additional trials the FDA might require, they would nees to file the NDA which costs moneg, they don't have an in house commercialization staff, etc. There is always risk the trial results aren't as good the next time, or that they need significant dilution, or a safety problem comes up. Suffice to say, nothing is ever guaranteed, and I urge you to double check me.
There are a lot of unknowns, what will the FDA say is the path forward, how long will it take to get through those steps, how long will it take? I'm excited about it, but I've been invested in this company for years (flipping catalysts), and I'm really patient. Its definitely not for everyone, it depends on someone's risk tolerance, how long they are willing to wait, etc, etc.
Happy to share more dd if you have questions, but as stated before I'm just an amateur investor sharing my opinion, you should always follow up with your own research.