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The interviews themselves aren't so much a problem as long as there's corporate counsel in the room alongside him. The gray area becomes a bit murky, however, when these interviews are then presented to different shareholders at different times based on whether they've paid for that privilege to early access.
Anavex is a public company. All information presented by the company must be presented to shareholders at the same time. This is why 8-K forms are required. Employees have a right to free speech on their own time -- the Pickering case attempts to clear the blurred lines -- but it's not as if Dr. Grimmer is speaking with Jesse about the current state of neurology as a whole or about his favorite sports team. If he's an Anavex employee, and he's discussing Anavex's with one shareholder who then essentially "sells" this information to others before giving it away later, that could potentially put Timo, Jesse and the company at risk.
I hope he reads this and stops. As unlikely as it is for the SEC to actually get involved, it's simply not worth the risk in my opinion.
Anavex was my first biotech investment. My portfolio currently holds a few other equally sizable biotech investments. I project Anavex to pay out in 2025, and the other two in 2026 and 2027.
I do not think I will ever buy another biotech again, because I've seen the worst of humanity on these message boards. It takes a special type of a*$hole to bet against anything that may offer a glimmer of hope to sick kids, purely because the ease of short-term profit outweighs long-term decency.
I'm not against short selling stocks. I believe it provides necessary liquidity and disincentivizes crooked CEOs from taking advantage of shareholders. But I am starting to think shorting biotechs with market caps under $2B should be illegal, and instead the SEC ought to step up enforcement of these companies to make sure they aren't misleading investors.
The natives are getting restless.
Maybe I see things a bit differently than you do. If the plan is to partner up for AVXL, we want max value in that partnership. It takes time to create a product that has achieved max value. The more evidence we can gather that supports efficacy, the more we can integrate precision medicine techniques to identify the best patient candidates, the more we can use technology to help market the product --- all of this is long-term accretive to maximizing the value of the company.
I know a family that started a business many years ago in the local mall. 20 years later they sold it for $250 million or something. Today, the company is worth north of $30 billion. They sold partially because the CEO wanted to retire, but also because the impatient investors wanted their money ASAP. In 5 more years, this company is projected to be worth north of $100B. Do you think the VC's who demanded a sale at $250M regret their decision not to wait another 5-10 years? I do.
I am glad that Dr. Missling is taking his time and making the right moves to ensure that when we do enter partnership discussions, we are doing so from the position of greatest strength possible. If that takes a bit more time, so be it. I've got plenty of other stocks and investments to occupy my time until then.
I don't consider either of them to be grifters or con artists. I treat their posts no differently than anyone else's, with the exception of maybe Dado who is an actual neurologist and understands the brain better than anyone on this message board.
I do agree there is a ton of free information out there and nothing Pietr or Jesse post will have any impact or effect on the share price. They could both sell their entire stakes tomorrow and it wouldn't impact my decision to hold or sell. I would rather invest that money in more AVXL, but to each his own...
What concerns me are the interviews with Anavex employees without corporate counsel in the room. I don't want Dr. Grimmer or anyone else inadvertently saying something he shouldn't. He's an MD, not a trained attorney, and slips of the tongue happen all the time. I don't think the benefit of insight he's allowed to provide outweighs the risk that he says something that puts Anavex in the crosshairs of the SEC and potentially liable for monetary damages that shareholders will ultimately pay for. If Jesse wants to go to these conferences and report on them based on what he asks at the Q&A, great! But the idea of personal interviews with current employees seems unnecessarily reckless to me.
This is what I think, too. We will be filing an NDA for Rett once the Excellence data reads out. For AD, we are going to wait for a peer-review, which should hopefully silence any criticism that Blarcamesine is ineffective or the trials were conducted improperly. At that point, AVXL detractors will find another subject reason to attack Dr. Missling and they'll continue to do so until a partnership is announced.
By then I suspect most of this message board will have also moved on.
Why is it mind-boggling? Peer-review exponentially increases the odds of FDA approval. I would guess that Dr. Missling is being advised by those who have FDA backgrounds, and playing it safe is the right approach to take. If there's more evidence to be gathered, gather it and then report it.
CVRs are generally a scam and rarely pay out. Looks great on paper but various delays usually mean they’ll expire worthless, leaving the entire company to the acquirer for pennies on the dollar.
I may decide to hold my stock forever. Look at Amgen. A $10,000 investment on New Year's Day 1990 would be worth around $120 million today.
Blarcamesine most likely isn't a miracle drug and odds are good that something better will eventually come along, but it doesn't have to be a miracle drug to become the new standard of care because that's how low the bar has been set.
If it can do everything its competition does but in a safer and more convenient method, it's going to be approved in due time.
The best test to determine if something is a material event is to ask if a reasonable person's investment thesis might change if the event were made public. If the answer is yes, it's a material event.
In the case of the NDA filing, any reasonable person would already presume Anavex would eventually file one. We invest with the expectation that an NDA will be filed so hearing that one was would not change our investment thesis significantly. On the other hand, should Anavex decide to scrap Blarcamesine and not apply for FDA approval, this would significantly affect how we perceive the investment opportunity and would require an 8K disclosure.
Similarly, we don't see an 8K every time money is spent or received because that's what businesses are expected to do. Nor is an 8K required notifying investors that Anavex has applied for a grant. However, if Anavex is awarded a grant that has a significant impact on its balance sheet or operations, that would be considered material and would be subject to an 8-K filing.
Let's suppose for a moment that Dr. Missling did sell everything. His financial advisor is the Steve Miller Band and the advice was to take the money and run. Dr. Missling is now $4 million richer and the investors are all wondering if he knows something ominous that we do not.
1. If this guy has the balls to not only rob retail shmucks like us, but also to rob Wall Street by attending road shows and pitching them a known scam, I tip my hat to him because he's clearly living for the moment. Dr. Missling looks like he'd last about 10 weeks in even the most minimum of minimum security facilities before his hair dries out. I simply don't see him taking the chance of using prison shampoo for the next 3 years.
2. If the $700k salary from Yahoo Finance is accurate, his take-home is probably closer to $350k. I can see rent taking up at least 30% of that for any decent place worthy of a publicly-traded CEO. I can't speculate on his ability to cough up $800k out of pocket. Can he probably afford it? Sure, but who knows how much of a dent it would put in his wallet. Perhaps Dr. Missling lives hard, maybe he's got a secret lover, who the hell knows? The point is that it's his decision alone to make and there are a dozen reasons besides lacking confidence in his company not to keep the shares.
3. It's not as if the guy doesn't already have a ton of shares as it is. If an extra $4mm cash helps him sleep better at night or improves his cash flow or lets him buy the house he's always wanted, good for him. He's probably a lot more frustrated by the slow progress than anyone here considering how much he stands to make if the drug works.
4. To those who think Blarcamesine is a failure and Dr. Missling is just slow rolling, again I ask why does he need to do that? He's got $150mm cash or whatever it is to play with, and he could easily pivot to A371 or anything else in the pipeline, or acquire another drug candidate if he doesn't like the pipeline he's working with in-house.
I still think he's holding 232k more shares today than he owned last week. That's how I am interpreting this report. We'll see. I could be wrong, but I don't think so.
I don't understand why everyone seems to be so confused. It seems apparent that Dr. Missling is walking away from this with about 232,000 new shares that could be quite valuable in a few years if the company delivers on its goals.
In order to acquire these new shares, he had two choices: pay out of pocket and keep 500,000 shares, or sell some of the exercised shares to pay the associated costs and taxes. This is why his net gain is only 232k and not 500k.
If you want to say he lacks confidence or conviction because he didn't drop 800k out of pocket and instead chose to ride free shares, sure, that's one way to look at it. But I also don't know his financial situation. NYC is an expensive city, and he takes home about 350k net after federal, state and local taxes. That's good money but it's probably not enough to build a nest egg large enough to simply drop $800k from the petty cash fund. And, Dr. Missling seems like he's pretty conservative with money management (one reason why Anavex is in an enviable financial spot). Why wouldn't he ride free shares? It's the prudent thing to do because nothing is for certain, and he would be the first to tell you that.
Shareholders were diluted 500k today. No big deal to me, because all of my models project at least 100mm outstanding shares. No matter what happens with the Excellence data, Anavex looks to have a home run drug candidate for the adult Rett patient population and that alone dampens most of the risk at the $8/share price range.
Maybe it's just me being more patient than the average investor, or my propensity to invest with an Occam's razor mentality, but I don't stress over any delays nor do I try to automatically extrapolate to the worst-case outcome (scam!) with specious evidence. Here's why:
1. Generally, companies running a scam try to avoid the limelight. They don't attend legitimate investor roadshows and global healthcare conferences. They aren't listed on Nasdaq. Their CEOs don't have multiple advanced degrees from top research universities.
2. All of these self-imposed deadlines are completely arbitrary. Missling will release the full data results when he is ready. Most likely it'll be in a peer-reviewed journal and that's beyond his control. We know per the most recent PR that Anavex has been in contact with the FDA, and maybe we're waiting to hear back from them. And every time Dr. Missling announces anything, the same critics will come up with the same reasons not to believe him. Peer review, partnership, or FDA approval are the only ways to permanently silence the criticism and fear mongering.
3. There are doubts worth airing, so let's air them. I'll start with the most obvious: the misdirection with changing endpoints, etc. We're past that. The damage to the share price has been done. We also know it's likely we'll have a P3 trial -- worst case, we wait another 24 months to see Alzheimer's through to the end. What else is there?
4. Even if Dr. Missling doesn't exercise all of any of his warrants, or he cashes them out instead of holding cheap shares, it's not the end of the world. People have all sorts of reasons to cash out and with him still holding a substantial number of shares, he's going to be generationally wealthy if Blarcamesine works. Personally, I've seen enough to believe that the drug works and I think the FDA will approve it. I'd actually prefer he not dilute the shareholder pool any more with converting those warrants...
I wouldn't be surprised if the FDA direction to Anavex was to focus on Rett first.
LakeshoreLeo is a retired air traffic controller, right? I'll bet he's seen airplanes backed up for hours, waiting to take off or land, no fault of their own. Delays happen, especially when the FDA spent the better part of two years focusing almost exclusively on the pandemic.
What makes you think they will present at AAIC?
That seemed like the obvious place a few months ago but now it's looking less likely. So we wait. No big deal.
And message board pumpers sell into the fear, exiting their positions without posting, disappearing for a few weeks, and buying back in cheaper at the expense of those they suckered.
Corrected it for you. Shorts aren't the only problem. Irrational pumpers promising dreams of $1249/share within 36 months are equally to blame.
Every PR from here on out will be a "nothing burger."
There are only two PRs that matter to shareholders at this point:
1. FDA approves Blarcamesine for (insert disease)
2. Anavex has partnered with (insert company name)
Other than those two PRs, nothing else matters to investors. This doesn't mean that additional data results aren't noteworthy or unimportant. But the real value of this investment will only be unlocked with one of the two above press releases.
Fortunately for shareholders, each passing day brings us one step closer to resolution -- good or bad. And the more independent sources confirm Blarcamesine's efficacy, the more difficult it becomes to attack the company on the premise the drug doesn't work (a common criticism before 2020) and the more we'll see other criticisms that are subjective in nature, such as the CEO's performance, because performance is linked with stock price and it takes time to increase the value of a company that doesn't yet produce any revenue.
It's about that time when certain options holders are hoping for a last minute Hail Mary. The spike and pump today certainly trapped more than a handful of novices, but anyone who purchased shares today at the high or the low should be sitting in a good spot if the Rett data continues to report positive results. Even at $10, the stock feels cheap for what its pipeline purports to hold.
No, I think we are very close to seeing that number as a new price floor. We are now past the investing conference road show stage. If you're into horse racing, there's not much time remaining to place any wagers. The Rett topline data is in the gate.
The FDA will be hard-pressed to reject a drug that helps children if it's moderately effective and widely tolerated. FDA approval + Alzheimer's peer review is all the validation we'll need. The likes of Adam Feuerstein will quietly move on to another early stage victim and Blarcamesine will either succeed in the open market or it won't.
Today's price action has nothing to do with the long-run. I do believe news has leaked one way or the other about AAIC, but I don't think we need AAIC to announce good results. It seems that Dr. Missling prefers CTAD as the venue to make big splashes.
If you think a bunch of cheap shares are going to be issued with the warrants, shorting may not be a bad strategy.
I think the more likely explanation is news leaked that Anavex will present data this July in Amsterdam.
I was on the toilet and heard alerts coming from the other room that it had dropped below $9. I had to decide whether to run to my phone to place a trade, or assume the risk of not making it back in time.
I made the wrong decision...
Congrats to those who made the right one.
Anavex could charge $1500/year and there would still be billions of dollars of profit over the lifetime of the drug for shareholders to enjoy. The attempt to curb skyrocketing drug prices is a step in the right direction that will benefit the majority of citizens, which ought to be the objective of any functional government.
Blarcamesine is by all accounts comparatively inexpensive to produce. The childish response is actually using logical fallacy to reduce Blarcamesine's revenue generating potential to an all-or-none scenario. It's possible to make a profit without the company looking like a bunch of greedy a**h*les. Otherwise, that makes us no better than Martin Shkreli.
I grew up with an undersized kid who was always a very good athlete, the best in the neighborhood. Typical big fish in a small pond story. When he signed with a D1 program on an athletic scholarship, a few of us discounted his odds for success because of his size. It wasn't until he turned pro that we had to admit we were wrong.
For a small company like Anavex, peer review provides the same validation that being drafted by a pro team was for my childhood acquaintance. Until then, there will always be skeptics for a number of reasons. Pursuing peer review is a good strategy even if it's frustrating to lose some control over timeliness. Ultimately, it will silence the skeptics and provide additional supporting evidence the FDA cannot ignore.
So you only want the effective drug to be affordable to those with discretionary income?
Low prices are a good thing, if a drug is effective it should be available to anyone who needs it.
If it means a bit less profit to Anavex so be it.
Who is Lane Simonian and why should I care what his opinion is? I'd much rather hear from Doc, Dado or any of the other posters here with subject area expertise.
Simonian appears to be an amateur without formal training, similar to how Adam Feuerstein lacks formal science training yet writes for Stat News. Does it mean they are incapable of competent analysis? No. But I am not going to make investment decisions based on either's opinion of Anavex, for the same reason I wouldn't ask my physical therapist how to renovate my kitchen. Subject area expertise and formal training do matter, somewhat.
It's the same when Anavex meets with investment banks. One time, last November, word leaked out that we took a meeting with Piper Sandler. I'd be willing to bet that there have been other meetings with investment banks but we don't know about them.
I have another investment where the CEO is very transparent. Here's an excerpt from a recent conference call where he's answering an analyst's question about if the company has the capacity to go at it alone.
Imagine what would happen if Dr. Missling ever spoke like this at a shareholder meeting:
"Yes. Thanks for the question, Franc. So, our belief has always been that this product is best suited in the hands of a pharma or a large biotech group that already has an existing primary care footprint in place. And I think that’s something that we have been in discussions with potential partners, and that will continue with data. We think that the data sets in Q2 are going to be instrumental in furthering those discussions. With that being said, if this is in our hands, as we get to market, we do see a real opportunity to move this ahead in an efficient, cost-efficient manner."[/I]
There's a difference between the CEO having nothing to talk about, and nothing he wants to talk about publicly with you.
At this point an investment in Anavex is a bet on Dr. Missling's credibility. That's it, nothing more. He's either telling the truth or he isn't. If he's telling the truth, Blarcamesine will most likely be approved and it will probably become the standard of care until something better comes along. The inverse is also true -- we know that if Dr. Missling is indeed building a house of cards, at some point it'll be exposed.
I've seen the work of sketchy CEOs who screw over shareholders without any care or concern and from my vantage point, Dr. Missling doesn't resemble any of them. I also don't know of too many CEOs who would manipulate, hide or cherry-pick data and then seek accelerated approval.
Unscrupulous CEOs lie when they are out of options and their back is against the wall. That's what happened with Elizabeth Holmes -- she simply ran out of options to keep the lie going. Dr. Missling doesn't need to lie about Blarcamesine. If it doesn't work, oh well. The company is flush with cash and credit and has a bunch of other drugs in its pipeline. If none of them look promising in light of a Blarcamesine failure, there's enough money to buy some other P1 or P2 drug that looks promising.
Dr. Missling has options and the fact he continues to spend his attention on Blarcamesine seems like a bullish indicator to me.
"Serious money Wall Street investors are not convinced, at least not yet."
Good. If they were convinced, Anavex would not be considered potentially undervalued and would not present a good risk/reward to investors.
There are 4 possible outcomes when you invest in the stock market, and three of them will never put you ahead of the pack.
Chuck Noll also went 1-13 his first season coaching the Steelers. The following season he went 5-9, then 6-8. The wolves were howling for him to be fired.
He won a few Super Bowls because the owner had the fortitude not to listen to public sentiment. I'd bet many of those who wanted Coach Noll gone never admitted they were wrong.
Sounds familiar...
2-3 years? Fine with me.
I remember staring at a clock once for about 25 minutes straight during a boring lecture in my least favorite college course. I don't know how many times the professor looked over and saw me watching the clock, but at one point he tapped me on the shoulder and said, "Gator, time will always pass. The question is whether you will?"
He inadvertently taught me an important lesson in not worrying about how long something takes. Time will pass. If it takes me an extra 2-3 years to see this investment/gamble through, so be it. Time will pass.
Huh? If he were tapping into LPC's "unlimited cash" stash so much to create the illusion of running a large company, we'd see that in the share structure reporting. As is, we're still well under the original 100 million authorized share limit. Until we exceed that total, I don't think it's fair to criticize Dr. Missling's spending habits. If anything, he's being frugal -- he could have created the appearance of a large company years ago if that's what he cared about.
Instead, he's hiring at the right pace and time. Bringing someone from the FDA on board wouldn't have been prudent 3 years ago but as the drug advances through its trials there is more need for expertise in areas where Dr. Missling lacks.
Let's see what happens over the next 7 years. I know that sounds like a really long time for some, but it goes by quickly. It doesn't seem all that long ago when we had the 2016 elections...
He has no financial skin in the game. It's all upside for him. Some CEOs like to align their interests with the shareholders to inspire confidence by putting up actual money, particularly when they feel their stock is undervalued.
The notion that he has too many shares falls flat because he's playing a different game than the rest of us: heads I win, tails you lose. Anavex has already made him a lot of money -- even with NYC taxes, Dr. Missling isn't struggling to pay the rent this month. If Blarcamesine works out as we all hope, he'll become infinitely richer than his wildest dreams and he deserves every penny. If it doesn't get approved and become a blockbuster, no harm no foul for him. That can't be said for the rest of the investors.
I've supported and continue to support most of Dr. Missling's moves. The one issue I have is the lack of insider buying. Not just from him, but everyone involved. It's odd. You'd think they'd all be buying hands over fist at these prices, every opportunity they have to do so.
Their silence, like it or not, is something that ought to be discussed more. I'd be curious to hear why they're not as excited about the drug as we are?
He has very little skin in the game. If Anavex goes to zero tomorrow, he's still walking a way having made millions with nothing to show for it. It would be nice to see him put a portion of the half-million or so he makes buying shares with actual money -- not ones that have been gifted to him.
It's a legitimate question for shareholders to ask. If you choose not to, oh well. It's more how he responds than what he says, anyway. He's not going to say anything we don't already know but a lot can be gleaned from his body language. If he doesn't feel confident in putting his own money into Anavex, why should he expect anyone else to?
Paper net worth and tangible risk are not one-in-the-same.
I would love to hear Dr. Missling's explanation for the lack of voluntary insider share purchases over the years?
Insider buying is one of the strongest indicators of confidence in a company's future, and this is my single-largest gripe about the current management. Purchases do not have to be massive, but they do help to align management and shareholder interests and it's unfortunate that we haven't seen consistent insider transactions given the positive momentum over the past 12-18 months.
Perhaps if any of you are attending the shareholder meeting, you will consider putting Dr. Missling on the spot to explain his lack of conviction when it comes to insider buying?
There's no doubt that a preventative element would be great for society, but I do not know how much economic benefit it'll provide to Anavex. This type of trial will take years, perhaps a decade or longer, and there is a ticking clock situation when patent protection runs out and generics become available.
A cheap, generic version of Blarcamesine would be incredible. By then I'd expect Anavex to be pursuing A371. The problem is that if Blarcamesine is as great as people like you say it is, if it's truly some miracle panacea, there won't be much use or need for anything else -- A371 included.
Blarcamesine is most likely a stepping stone. It represents the beginning of a new era of understanding CNS disease and Anavex will have first mover advantage if Sigma-1 becomes the next big thing. But that advantage probably won't last long enough to reap the windfall that would come with a preventative label.
Everyone is selling everything to prepare for the recession nobody wants to talk about.
Even Buffett sold his entire stake in a semiconductor company despite only owning it for a few months because of various geopolitical and economic concerns.
Fund managers lose their jobs if they don’t lock in profits. Also, there are safer places to park money right now in distressed blue chips on sale for 20-30% off. Not everyone is looking for a risky home run. Particularly not hedge funds that rely on others’ money
The problem is that my calculator only goes up to 10 digits and I forgot to add back the extra 0.
Yes, this definitely changes things a lot! Blarcamesine is potentially more valuable than my basic calculator is capable of handling.
(But I prefer to never admit I was wrong, instead I'll say that my model is just extra-conservative!)
Thanks for the correction.
I agree. The rare drug market will shoulder the burden of high costs, because that's the only way cures for rare drugs will ever be discovered. There has to be an incentive for private companies to pursue commercially unprofitable ventures. The cost of helping those born with rare conditions is paid by those fortunate enough not to need these breakthrough treatments.
Blarcamesine is going to be affordable and accessible. This is one of its big selling points, all other things being equal. I don't think people realize how difficult transportation can be for some populations, particularly the elderly. Unless the injections are done at home, a lot of people not only can't afford the "-mab" treatments, they can't afford the cost of the ride to and from the doctor's office.
Some fun math with very basic back of the napkin discount cash flow models:
Assume the following:
$10 pill x 360 days x 3 million users = ~$11B gross revenue
$11B x 20% net margins = $220mm net earnings
$220mm / ~100 million shares = $2.2 EPS
Also, let's assume a 13% discount rate, a 10% growth rate over the next 5 years + 0% terminal growth. The present intrinsic value is $34.
But if you really want to get silly, assume in a few years we've got 6 million users and we're charging $30/day. Medicare is still picking up most of the tab. Now it's 6 million x 360 x $30. EPS is now $65. Assume the same 13% discount rate but bump growth to 20% over the next 5 years and keep terminal growth at 0%. The new intrinsic value jumps to $850.
The point is, if Blarcamesine can make it to the market, it's still got a ways to go before I think people can really say it's a commercial success. Biogen, Lilly et al aren't just going to roll over and quit. If anything, more focus on Sigma-1 will lead to fewer people discounting the possibility of A-371. Anavex might become an industry leader in the Sigma-1 space. Dr. Missling knows this, and I don't think he's going to accept any offer until he knows just how valuable the pipeline is worth.
90% for Rett
70% for everything else.
Up from my 5 or 10% odds back in 2015 when it looked like Axovant was our biggest competitive threat…
Supposedly this is where Anavex could have a major advantage. The cost of manufacturing a pill is significantly cheaper and more convenient than going to a clinic for injections every couple of weeks.
I'll bet Anavex gets priced around $25,000/year with Medicare picking up about 80% of the tab.
I’m looking at the Jan ‘25 $27 calls.
If this gets accelerated approval in the next 6 months, the 12 months time premium remaining should pay out nicely