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Not exactly sure what you are talking about, peeved. I was responding to a question about not having a conference call following earnings release until after CTAD. The earnings will come out before CTAD and I expect a conference call the same day. I think you are talking about a conference call related to a top line readout PR. Correct me if I am wrong.
I can't imagine AVXL not holding a conference call right after its earnings release.
No earnings conference call before CTAD? Do you think AVXL will file its 10-Q and just not talk about it for a couple of weeks?
Good point, boi, and also that Eisai has ultimate say on pricing of the drug.
You, as usual, are the misleading character here. You expect that the CEO of the company has to be in attendance at CTAD all four days. Somehow I think he can afford to miss the opening day which begins at 4PM with a welcoming ceremony and that shareholders will be far better served by his making a presentation at Rare CNS Summit you cited.
Pazzo, I won't answer for Mayo (or TTT), and I will admit that I have neither been to a major biotech conference nor have I been a significant investor in the sector. However, I did run a modest sized small/mid-cap hedge fund in a quite different sector for a number of years, and I found attending certain industry conferences like this one to be very useful. You may be quite right about the live streaming and, of course, non-public information won't be dished out - perish the thought! However, Mayo will undoubtedly schmooze. He will chat with Anavex personnel and related researchers. He will likely meet other researchers and no doubt some clinicians, who will have interesting perspectives on the Anavex approach. Perhaps he will also meet some biotech analysts and investors and tap their thinking...maybe even a few BP execs strolling about. With the innuendo, color, and some details of details, he will likely sharpen his mosaic beyond what is simply laid out in the formal presentation. Anyway, he has already provided us with some useful analytical work without charge, so I have no problem throwing a few nickels into the pot for him to schmooze....
Wake up, BIO. Not only is the NASDAQ down more than 1%, but the biotech indices are down a ton.
Whoa, ckent, that looks like an ancient Mercury Redstone rocket! Can't we do better than that? Someone have Nell call Elon for a better booster...
Growing, do you know if CRTX also joined the CTAD party as a “late breaking” oral presenter?
I assume that if they haven't requested the exemption, they will shortly.
If they grant BIIB’s request, they have to grant AVXL’s request. The materiality to AVXL is far greater than to BIIB.
Did anyone notice that SAVA, which had been up earlier, took a bit of a dive in the afternoon and finished down about 1.5% for the day? Just as it started turning down AVXL began its afternoon surge. Wonder if some AD riders started to change horses with the AVXL finish line potentially closer in sight…
Thanks, power, but I am still a bit confused. I see the B/E presentation scheduled after the opening ceremony and the first keynote address. I also reread the CTAD embargo policy ("All research is embargoed until the date/time it is available on demand or shared at a CTAD live presentation.") and did not see a distinction for late breaking or not. That said, I defer to you or others who are likely more knowledgeable on biotech conference protocol.
Steady (or anyone else), if "TLD data is not material UNLESS it shows a clear trial failure," how was Biogen able to release its Lecanemab data in contravention of the CTAD embargo? The trial was certainly not a clear failure, and they obviously got an exemption to the embargo. That exemption is for publicly traded companies whose counsel can successfully argue to CTAD that withholding the data from release would contravene SEC regulations.
Amateur, here is the Answer:
Assuming, as we all do, that it will have a meaningful impact on the stock, and agreeing with you that they had a decent idea of the results before the CTAD deadline (9/30), they will be releasing the results before Halloween!!!
I believe you are absolutely right, jmvho. BIIB got an exemption from the CTAD embargo to release its TLD at the request of legal counsel, and there is no doubt that Anavex, as a public company with even more at stake in terms stock price, made the same request and has already received the same positive answer. The only question in my mind is whether the data release in a PR will be in the next few weeks, as you suggest, or whether it will be in the next few business days. I tend to think that it will be the latter.
Biotech index driven up by AMGN rec from MS...Doesn't hurt, but I suspect that AVXL is marching to a different drummer.
In regard to whether a company can sit long on a “good news” trial result, let’s remember that Biogen’s counsel had to persuade CTAD to allow them to get an exemption on that organization’s embargo in order to release their AD trial results (or at least the highlights) prior to their presentation. That exemption was based on the SEC’s material information rules we are discussing here. If that really applies to Biogen’s results, it would certainly apply to similar or better results from Anavex, whose stock would surely enjoy a higher percentage gain, given the far smaller size of the company.
Not sure what the point of this post is. Yes, "All research is embargoed until the date/time that it is available on demand or shared at a CTAD live presentation"...but, if one reads further, one notes that publicly traded companies can request an exemption from CTAD on the embargo if so advised by their legal counsel in order to comply with SEC requirements by releasing certain data. Obviously, Biogen/Eisai must have requested such an exemption (since they are presenting at CTAD) and it was granted. Anavex could do exactly the same thing.
Steady, it befuddled me as well. it would appear that there was an 18 month "Core Study." Doc found (from a PR by Eisai) that they completed enrollment in March of 2021. Add 18 months and you have September 2022 as the completion date for the Core Study, or so I surmise. I believe that the September 2025 date we see as estimated completion includes a three year extension.
Well, that is your view. I see it as Biogen scrambling to put out a highlights reel in order to quickly try to cover the stink of Aduhelm, get a slot at CTAD, throw the first punch (or is it a jab?) in the effort to temporarily become hailed as the new SOC for AD and for the outgoing CEO to attempt to exit on a high note of sorts.
Thanks, Doc. Interesting. This 18 month study would then be completed no earlier than sometime this month, September 2022.
Does anybody here know when the recently released Eisai/Biogen Phase 3 AD study for Lecanemab was completed? I didn't see a date mentioned in the press release, and when I went to ClinicalTrials.gov there seemed to be nothing with a 2022 completion date. (There was one suspiciously similar that was labeled active with an estimated completion date of 9/15/2025, but perhaps this 18 mo. piece announced the other day was the "Core Study" and released prior to the conclusion of the whole trial?)
$19B added in market cap for the two partners combined by this announcement: $11.5B for Biogen (BIIB) and $7.5B for Eisai (ESALY)
I love to see insider buying as well, but looking at the compensation tables, I would point out that Cassava stuffs more cash into Mr. Barbier's pockets than Anavex does for Herr Doktor Missling. In 2021 Barbier had a salary of $975,000 and was awarded a bonus of $750,000 for a total of $1,725,000. Missling, on the other hand, had a salary of $550,000 and was awarded a bonus of $110,000. So Barbier had much more cash to throw into market purchases. Correct me if I am wrong, but while he did exercise some options, I don't see any open market purchases by him over the past year..
On round the clock production that would be not quite a dozen pills per second. On the other hand, it would only take one semi-truck to haul away the entire annual production for a million patients. Make it so, HDM!
Excellent (and tightly crafted) post, boi. A great summary of the developing thesis.
It is Friday, It is the Summer. People head out early for the mountains or the beaches. So it has been for market trading volumes since time immemorial...
nidan, I really think that this article is HUGE (as the savior of the Wollman Rink might say). As you can see, it is all over the internet. I think that the story will be picked up by the WSJ and the NYT no later than Monday and possibly on the front page. The failure of the amyloid beta directed research is not news to people on this board or to many within the research field. However, the fact that so much of it over the last 15+ years had been underpinned by 2006 research that was likely fraudulent will grab everybody's attention and cause a tremendous amount of hand wringing. Hopefully this all builds to a crescendo just as Anavex presents very successful results of its Phase2b/3 AD trial. A new approach unrelated to the discredited recent path for Alzheimer's - the timing couldn't be better!
Passing on the altar boy gig may have been a mistake, sab. Plenty of cash to be made on weddings if your were willing to work for short stretches on a Saturday. You redeemed yourself with 4 years of Latin later, whereas I was willing to stop at 3 in favor of another science course. (Curiously, my high school didn't offer Biology [which puts me in debt to others on this board], although that didn't seem to stop Anthony Fauci, who graduated a decade or so earlier.)
The very best of luck in your upcoming effort to reclaim quality of life.
Memento Vivere!!!
Plexrec, as to my investment in AVXL, I first got involved in late '20 and tried to get a feel for the stock as I learned more about the company last year. I traded some, and I don't think my position ever exceeded 5,000 shares. This past spring when the market seemed to provide an exceptional opportunity I purchased a quite significant amount of shares at an average price in the low $10 area.
While my background has been in the investment business, the sector hedge fund I founded and ran for a couple of decades had absolutely nothing to do with Biotech. Given that, I very much respect and appreciate the contributions by falconer and others to my understanding of the science involved here. I do find Anavex to be a very unique opportunity - not without risk, of course - and watching its progress over the last year has given me increasing confidence that they really have something special here. Best of luck to all the AVXL investors (and, yes, to the traders too, who add liquidity) and, of course, to the millions of patients who hopefully will be able to significantly benefit from the Anavex drugs across a wide spectrum of CNS conditions (and beyond?)...
Spot on DFRAI! After reading the posts yesterday trivializing expectations on AVXL ever getting to $500 per share in the foreseeable future, I had the very same thought about the potential $40B+ offer for SGEN by Merck (discussed on the front page of the WSJ and a factor that boosted the Biotech group yesterday). A successful Phase 2b/3 AD readout that catapulted Blarcamesine into the standard of care for Alzheimer's over the short/intermediate term could certainly push AVXL to a similar revenue level and valuation by 2025. The $40B+, BTW, translates into roughly $500 per share. Investors should take things one step at a time, but the potential prize is indeed huge.
Why didn't I think of this! Combine an antibiotic (Cipro) with an NSAID (Celebrex), tweak the mixture a bit for each CNS disease,...and, bingo! Well, anyway, a lot of neurons must be firing today since by the session's end NRSN will have turned over 6x the total number of its shares outstanding and traded a quarter billion dollars worth of stock.
Jonjones, do you know for sure that this will be a live, in person event, rather than a virtual conference? I am hoping so and believe it should be.
The headline about "Barclays PLC investing $3.34 Million in Anavex" is misleading. It is possible that a fund of theirs purchased AVXL, but it is more likely IMO that Barclays purchased shares in the stock as a broker for one or more of its clients who hold it there in street name.
In my opinion, the only "IF" in there is whether the company is successful with the Phase 2b/3 AD trial. If so, FDA approval and a triple digit price will follow in due course.
Speaking of a triple digit AVXL stock price...
First of all, falconer, I would agree with the scenario you have laid out concerning the unfolding recognition of Anavex' value in the market over the next 18 months or so. I also concur with the the longer valuation parameters that you have laid out in prior posts, based on market size(s), drug pricing, etc.
Sometimes it is also useful to make relevant checks based upon industry transactions. I am rather surprised that no one here has cited the parallels in today's announcement that Pfizer was buying Biohaven (BHVN) for $11.6 billion. The primary asset in the deal is Biohaven's new migraine drug, Nurtec. The latter is part of the new class of migraine treatments known as CGRP. Nurtec went on the market as a treatment for acute migraines two years ago, and more recently has been approved for prevention of migraines. The market for migraines is projected to grow to the $10 billion to $12 billion range by 2030, and "analysts project the drug could have as much as $4 billion in sales" by then, according to the WSJ.
So, shifting back to Anavex, I would suggest that the global market for CNS treatments (i.e., Alzheimer's, Parkinson's, etc.) could easily be 2X that of migraine drugs by 2030. There are a number of CPRG competitors, although Nurtec seems to be distinguishing itself by being the only one approved for migraine prevention at this point. Anavex seems to stand alone with its Sigmaceptor Platform, and, like Nurtec, it is also aiming at disease prevention (in the case of Alzheimer's, at least). Those points suggest bigger shares and better margins.
If one doesn't believe the above arguments for higher valuation of AVXL vs BHVN, simply take the price paid the latter, $11.6 billion, and divide by the number of Anavex shares. Using 80 million shares yields $145 per share; using 100 million yields $116 per share. All this is just a way of saying that falconer's proposition that AVXL should be trading at a triple digit price by early 2024, assuming successful Phase 2b/3 AD results later this year and consequent FDA approval in 2023, is supported by the BHVN acquisition price.
FWIW, after trading at more than two and a half times the market capitalization of AVXL for periods last year, the market cap of SAVA has finally dipped below that of AVXL today.
I have good news for you Falconer. In Cell A5 you are off by a power of 10. The calculation yields $10 billion, not $1 billion.
You ask:
(what) would inspire us to present at the Needham conference 2X within a 30 day window?
I would suggest that HDM is angling for near term coverage/recommendation of AVXL by Needham