I would really like to hear something concrete about this, since Novo’s method isn’t being utilized. In my opinion, it’s quite unrealistic to expect that HIMS could bring something like this to market so suddenly and quickly using different technology.
And I repeat: HIMS’s pill is a much bigger question mark than compounded s.c. semaglutide products. Safety warnings regarding this are completely justified. This is actually a dangerous game; HIMS now has a completely unstudied and untested drug on the market.
Take a look at this. This could be a bullish thing on many levels.
Hims isn’t a one-trick pony, so if the drug doesn’t work, they’d hardly bring it to market, as they would have more to lose than to gain in that case. Hims aims to be an all-encompassing department store. It feels a bit like Novo messed up with Hims in the spring.
“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products. The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
The market also finally seemed to internalize the absurdity of Hims’s pill as more information and opinions became available. The stock ended the day in the red and fell sharply in after-hours trading, approaching the $20 mark.
It will be really interesting to see if Hims starts to back down after this. Humbling himself before others certainly hasn’t been part of the CEO’s toolkit
An episode of Houseltak regarding Hims came out last night:
I recommend watching the video yourself; I think there’s a lot of good information in a package of less than 30 minutes. Since it annoys me immensely when people just link a video without explaining why one should watch it (either due to laziness or because they haven’t watched it themselves), I’ll list the most interesting points from the discussion / what I learned:
The guest, a user going by the handle “Cremieux,” is, by their own words, a “bioinformatician” (whatever that means) and a data analyst / GLP-1 researcher. I can’t judge how expert he actually is, but what he says sounds sensible.
If I understood correctly, in Cremieux’s opinion, Novo doesn’t necessarily have strong legal grounds in the lawsuit unless the FDA adds semaglutide to the “Demonstrably Difficult to Compound” (DDC) list, which it currently isn’t on. This was a surprise to me.
There is no scientific evidence as to whether Hims’s pill works at all. As I understand it, semaglutide is a large peptide, so it breaks down easily in stomach acid and isn’t absorbed without an effective delivery mechanism. There is no evidence for the “bioavailability” (biosaatavuus) of Hims’s product.
Hims promises that their pill doesn’t require fasting before taking it, unlike Novo’s pill. Again, there is no evidence that this actually works.
If Hims’s pill doesn’t work, it is a massive strategic error. It could also give the FDA a reason to tighten regulation on “compounded” (yhdistelmälääkkeet) drugs, which would hurt the entire industry.
There are no human studies on liposomal technology that prove it works with GLP-1 drugs. Cremieux apparently considers the technology suspicious for this specific use.
Liposomal technology is used in some other drugs, but applying it to GLP-1 drugs is completely new and untested.
I certainly didn’t expect this kind of news from Hims. Risk levels have gone through the roof, and I suspect there’s a 99% chance that their version of the pill doesn’t work and this whole game will backfire. Of course, if the pill actually works without major side effects or issues, then the sky’s the limit. I’ve bought Hims for 5% of my portfolio and I’m not going to start selling even though risk levels are elevated; if this mess ends in bankruptcy, it won’t make a huge dent in my portfolio overall. We’ll see if Dudum has lost it or if there’s actually some genius plan behind this madness. I still suspect the success has gone to his head.
Apologies if this is considered off-topic, but Cremieux is someone I’ve followed for some time, so perhaps I can share some thoughts. In my book, the guy has proven to be exceptionally competent and knowledgeable, and he regularly publishes (in my view) very good and comprehensive analyses on various topics. On the other hand, it must be said that he also seems to have quite strong opinions on a couple of things that might color his analyses—I don’t know for sure, as I don’t have enough expertise to evaluate those matters independently to compare the conclusions. One of these opinions is that obesity is a massive problem that should be solved immediately and effectively, and in the name of that goal, Big Pharma’s IP can be trampled on.
I hold the guy in high enough regard that, as a Novo shareholder, it’s bad news that he assesses the court will side with H&H in this case.
There’s quite a lot happening here right now, and I have to take a timeout to get the big picture. I’m sure there will be a lot of questions about this during the earnings call in a couple of weeks, and management will be expected to provide answers. Some moves could very well be seen even before then…
When considering possible legal proceedings, the situation regarding semaglutide itself isn’t different from last spring. It’s the same personalization as back then. Of course, I understand that the pill form is new, but that’s a separate chapter. So, nothing new since last spring. I’m particularly interested to see if the FDA actually reacts, and if so, how. From the FDA’s perspective, this individual case shouldn’t matter in the sense that their job is to draw lines that apply more broadly, and not just to this case—otherwise, they’ll be in deep trouble. They would need to come up with something really clever, but I believe they’ll either do nothing or just some minor fine-tuning.
My sympathies are with the Novo investors; you haven’t had it easy (and it doesn’t look good).
The situation is completely different from last spring because there is no de facto shortage of the drugs. Furthermore, it’s not actually compounding, but mass production under the guise of compounding. Both Novo and the FDA addressed this yesterday in their statements.
The pill form is precisely the thing that has also changed since last spring. Semaglutide is a peptide that is destroyed in the stomach without a “delivery mechanism”. Novo has a patent for SNAC technology, which enables absorption in pill form. And Novo also commented yesterday that the pill is not effective without that technology, and they have the only FDA-approved technology, which they have, of course, also patented.
I don’t know if it can be said more directly than what the FDA director said yesterday: that they are taking swift action. The FDA’s job is specifically to intervene in this kind of activity.
As a final note, I sincerely hope for the best outcome for the Hims investors on the forum, but there is now a lot of new risk involved in the investment following yesterday’s launch of the knock-off pill. Just by looking at the stock price, you can tell that Mr. Market is trying to say something: yesterday it opened up over 10 percent and eventually ended down ten percent in the after-hours following the statements from Novo and especially the FDA, and the same now in the pre-market. I wouldn’t dare bet against the US authorities and global pharmaceutical giants, especially since it’s really difficult to justify why Hims should be allowed to mass-produce and sell a copy of a patented drug that has just hit the market and is not in short supply, or to mass-produce and sell a less effective drug (if the patented SNAC technology is indeed not included in the pill) that is nevertheless marketed as being similar. This is, IMO, very questionable behavior.
Well, that is obviously what NVO is supposed to say. The efficiency is still very low; for this reason, the weekly dose of the tablet is 70x compared to the injection.
SNAC exists primarily so that the drug’s patent protection can be extended. Normal business..
I don’t believe for a moment that Hims would shoot themselves in the foot by selling a completely ineffective product.
It is true that more of the active ingredient is needed for the pill, but it is not true that SNAC exists to extend the patent. SNAC exists because it is essential for the pill to be functional and effective, as has been proven in extensive clinical trials. Without SNAC, Novo’s pill is not effective—meaning it does not work for its intended purpose—and that is a fact.
I would also remind you that there is evidence of the efficacy of Novo’s pill, but no evidence of any kind has been published regarding the efficacy of Hims’s pill.
You can be sure that when the semaglutide patent expires, generic semaglutide will hit the market practically the next day, even if the patent for the formulation (SNAC) remains in force. It’s not a magic bullet; there are certainly other closely similar technologies for the absorption issue.
Sorry, but this is just nonsense. You clearly follow the pharmaceutical industry and have a lot of good content in various threads, but you are completely wrong here.
SNAC definitely does not exist because “patent protection can be extended.” Don’t spread that kind of misinformation.
No more on this for now, but I specifically meant the situation last spring after the shortage ended. Regarding semaglutide itself, nothing has changed; Hims is still selling a compounded preparation, whether it’s an injection or a pill. The fact that time has passed and Hims has been allowed to continue selling semaglutide only works in Hims’ favor in a legal sense.
Even though I am an all-in Hims investor, I don’t want to close my eyes to things. My point was just that it feels a bit strange that Novo is trying to struggle with the issue now that Hims is offering a pill, almost as if it was Novo’s last straw. Introducing the pill to the offering now was quite a surprise, but I want to say this clearly: I already considered acquiring Novo shares (lappuja) in the summer for risk management purposes, but the CEO change and Novo’s internal problems did not inspire confidence. In my opinion, Novo should get its own house in order. Did the company not have enough legal expertise to anticipate this whole show? Hims management, on the other hand, has performed excellently. By reading Seligson’s material, I’ve learned to invest in a company whose management you can trust. In reality, these are very complex matters, and a lot is happening in the background that only insiders are fully aware of. My own expertise is not enough to parse it, so all that remains is my trust in the company’s management. Everyone, of course, makes their own conclusions and the money follows accordingly.
Quite a few people think Novo’s situation looks weak in court. I suspected as much, since the company hasn’t done anything about the matter over the past year. Novo has played its hand poorly with Hims.
There is a lot of guesswork and rumors going back and forth right now, with few solid sources.
How much does SNAC improve efficiency? It certainly improves it, but is it irreplaceable as a technology? I don’t think so. The composition of matter (CoM) patent for sema [semaglutide] expires in some markets as early as 2026. Protecting a product by patenting the formulation is an essential part of drug lifecycle management.
Are there any examples of a drug delivery technology so superior that after the CoM patent expires, generic competitors haven’t been able to enter the market because it’s impossible to find a replacement technology for the formulation?
Alternative technologies/ways to achieve absorption certainly exist and will emerge, but there is no evidence for them. There is no evidence for HIMS’s technology, nor could HIMS have produced such research. This is incredibly dangerous business, not just for patients, but also for the dynamics of the entire pharmaceutical industry. HIMS is engaging in blatant quackery by bringing a drug to market for which no research exists It’s quite unprecedented. And no, Dudum doesn’t have any data on this tucked away. HIMS would have brought it forward, just as they highlighted their own data on the results of s.c. semaglutide in their own patient material.
Novo doesn’t necessarily even need to get its hands dirty in this matter. The U.S. Department of Health has already referred Hims’ potential legal violations to the Department of Justice for investigation. FAFO.
It’s hard to imagine that HIMS didn’t understand what would happen now that they are bringing the pill to market; after all, they have experienced people on the board. There must be a financial reason why they are doing this and believe they will benefit.
A calculated move, not an accident or desperation—the question is what they think they will gain from this, as this challenges the fundamental premise of the entire pharmaceutical industry, namely drug approvals and patent protection.
Do they believe they can change the entire system so that this would actually be permitted?
If this is just the whim of one person (Dudum), then all self-respecting professionals should walk away from the board and dump all their shares.
In January, only one insider has sold, and the sales that occurred in December were mainly:
Most of these sales were executed in accordance with 10b5-1 plans. These are automated programs that insiders set up in advance.
So, the insiders aren’t selling or resigning; they must be convinced that this gamble is worth it for some reason?
Here is the official FDA statement on the matter from yesterday. The statement does not specify exactly what the agency intends to do, but I suppose all options are on the table for them.
The worst-case scenario would be semaglutide being added to the “demonstrably difficult to compound” list. Semaglutide hasn’t ended up there yet.
I’m getting a bit of a “storm in a teacup” vibe from this. Insofar as compounding has been permitted up to this point, I don’t see anything substantially new regarding this tablet form.
The clearest legal issue is if the advertising implies that Hims’ semaglutide tablet is a generic version of Wegovy. These cases might even be taken to court. I believe the marketing and regulatory professionals on Hims’ management team know how to phrase the advertisements so that no liability arises.
So he is a Republican representative. We’ll see if the FDA is as toothless these days as the SEC. I consider it very possible; that’s the kind of direction the Trump administration has been taking.
On the other hand, I still doubt that Novo has any real leverage against Hims, as they haven’t taken any action before.
It’s quite unprecedented. And no, Dudum doesn’t have any data on this tucked away. HIMS would have brought it forward, just as they highlighted their own data on the results of s.c. semaglutide in their own patient material.
