watching biotechs, gold & silver
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Jess, Thanks for the explanation. Love your forecast!
cheers
This is kind of interesting (not sure what it means)
From TomSilver39 at Twitter:
....The chemical structures, status and known uses of potential drugs for COVID-19 treatment.....
Voclosporin is one of the 10 drugs listed here:
https://www.nature.com/articles/s42256-020-00285-9/tables/2
Very positive post from our long time friend:
John_Galt
@BioLunacyJG
2h
AUPH Looks like good news early on in the launch for payer coverage for Lupkynis. Many of the larger state’s Medicaid programs are covering. Given the debilitating nature of LN, I believe many patients will be on Medicaid.
Catalent Announces Commercial Supply Agreement with Aurinia Pharmaceuticals for Newly-Approved LUPKYNIS™ Softgels
https://www.catalent.com/catalent-news/catalent-announces-commercial-supply-agreement-with-aurinia-pharmaceuticals-for-newly-approved-lupkynis-softgels/
Interesting timing- the day after ER: Aurinia Pharmaceuticals to Present at the SVB Leerink 10th Annual Global Healthcare Conference
https://ir.auriniapharma.com/press-releases/detail/212
The Lupkynis campaign is alive and active, contrasting the stock- which is not.
Everything looks great except for the market cap.
It could be a very interesting earnings call on the 24th.
https://78449.themediaframe.com/dataconf/productusers/auph/mediaframe/43645/indexl.html
Zeppo, GSK would be perfect!
They could protect their franchise, keep other BP's with LN programs at bay, etc.
Every major BP might have one or more lupus programs. I know the following do and there are likely more:
Roche (Genentech)
Abbvie
Biogen
BMY
GSK
PFE
MRK
Novartis
Bristol Myers Squibb
When you think of the billions already spent by BP, with essentially zilch in the way of positive results for the massive investments of time and money, the price we're sitting at is absurd!
I did have concerns about the monopoly GSK would have, anti-trust issues, etc., but Jess made a good case that it would be kosher if GSK scooped them up.
I'm thinking every day AUPH becomes more valuable, so this weird situation (decline after approval) could very well turn out to be a blessing, as the BO number gets bigger and bigger over time.
Didn't the garbage drug Benlysta sell for around $5B years ago?
Lupkynis has to be worth more!
Rheumatologists & Nephrologists call continued.........
Fugitive447
Bullish
05:05 PM
5. He took questions. One question was what the care model should be with 2 approved drugs. He said he would be using Lupkynis due to its speed of efficacy and lack of STEROIDS!!!! He did say he can see opportunities or certain circumstances to use Lupkynis along with Benlysta together.
6. Lupkynis will be used for maintenance no question. Also took a question about why not use other legacy CNIs. He said VOC is 4x more powerful and the change made in the drugs make up separate itself significantly from those other drugs. He said more on that but I can't recall at the moment.
Hear from expert rheumatologists and nephrologists as they discuss key clinical information in a live, virtual series
https://lupkynispro.com/speaker-series/
Pretty awesome call to Nephrologists and Rheumatologists today:
Fugitive447
Bullish
05:04 PM
AUPH
I listened in on this zoom call today at noon:
Lupkynis PI Speaker Program - Dr. James Tumlin - 2/16/21. This Dr called VOC the holy grail at Kidney Week and also gave testimony for the 23.7 patent.
This call was advertised to Rheumatologist and Nephrologist. I am not a Dr but did stay at a Holiday Inn Express last night. Let me tell you...after this call my faith in what I own was strengthened 1000%
What he said not verbatim
1. "We finally have something" is what he told his fellow practitioners.
2. Phase 3 study results and study design were phenomenal. He has been in contact with Aurinia and further study results forthcoming on important data points.
3. The decrease in steroid use is a huge distinguishing highlight of Lupkynis. Told the other Drs they no longer had to watch their patients gain 50lbs in 2 months and get diabetes.
4. He talked about the standard risk factors of CNIs, infections and things along those lines.
BR is Dennis? How do you figure?
And who is BT?
Canadian biotech to prioritize Rockville growth, ‘shift gears’ post-FDA approval
https://www.bizjournals.com/washington/news/2021/02/15/aurinia-pharmaceuticals-rockville-commercial-fda.html
Mr. Market is clearly a deranged lunatic.
Who would possibly want to buy a derisked, BIC drug headed for eventual SOC status? Why buy a dirt cheap, super safe future blockbuster, when the opportunity to buy something like GME and experience the wildly dangerous roller coaster ride? Safe and sane vs. chills & thrills. How could Mr. Market possibly get it wrong?
cheers
...they would have to spend more than $4b....
Isn't that way too cheap? That's only about $28 bucks (fully diluted)
Aren't we worth at least $35, maybe even $50+???
Jess, I get it. I'm just having trouble accepting it.
Sort of like what's happening to this gem here.
Best to you and yours,
May the best QB win
cheers
When do we get Rx numbers? Today or next Friday?
Does anyone here have access to scripts numbers?
Jess, have mercy. Bet against Tom?
Please tell me you're not serious.
Whoever you like, GLTA
cheers
This is truly insane- we're at $15.26. The close on Friday, pre-approval was $14.86
So the market says FDA approval plus the 2037 label combined is worth a colossal 40 cents!
And they have $3.50 per share in cash!
Take out the cash and it's nearly the value of the high of 2017 after P2.
Lucky we got the 2037 label- without it I guess we'd be at $14.88 or so.
Is there anyone alive who thinks the market is rational?
cheers
Lupus Foundation of America is incredibly lame.....
I did a search for Lupkynis:
https://www.lupus.org/search?_limit=10&_page=1&keywords=lupkynis&_sort=relevance&language=en
7 hits, but reading through them is very disappointing. Outdated, incomplete, inaccurate, etc.
It's sad that a major advocacy organization (that is presumably well funded), is doing such a piss poor job for Lupus Nephritis sufferers.
Someone needs to get them to improve the quality of their information
BR, re: ....the retail crowd is abandoning the ship of hope..
You really have become an optimist.
The proof to me is that you chose the nomenclature 'ship of hope' rather than 'ship of fools'
cheers
I also like the Bucs & Brady
Hope they not just beat the spread but actually win
How long a monopoly? Re future competition:
If this poster is correct, we're in great shape-
update on future competition: most is IV, a few SC, furthest they've come is P2 with around ~80 patients, two in P3: Gazyva (which is more like Benlysta 2 IMO) reads out in 2028, secukinumab (SC, Novartis) in 2026 (seems like no P2 phase, looks risky).
The only oral with a potential is BMS-986165 (Bristol-Myers Squibb), P2 finishing in 2023 both in SLE (NCT03920267) and LN (NCT03943147), and that's about it.
So no competition before 2028, if BMS fails there's very unlikely any other novel oral tx coming before 2032. That's like min. 8yrs of monopoly, long patent runway and bar set very high for newcomers, that's as good as it gets, BP can't ask for more IMO.
Don't check out that site- it's bogus
Got fooled- it looked so pretty!
Some of the numbers are accurate, but loads are not, so it's essentially worthless
cheers
Check out this short interest site- really cool!
The name is a misnomer; it's not actually "naked shorting" that is being shown.
They're taking the daily Fintel short data and displaying it graphically and as a column.
https://nakedshortreport.com/company/AUPH
Ganz, I was way off- these guys say P3
The company’s leading drug candidate is ANAVEX 2-73, which is in Phase III clinical trial for the treatment of Alzheimer’s disease and Phase II clinical trial for the treatment of Parkinson’s disease. Plus the company’s drug candidate ANAVEX 3-71 is in Phase I clinical trial for the treatment of frontotemporal dementia and other dementia indications and preclinical clinical trials to treat Alzheimer’s and Parkinson’s diseases.
https://pulse2.com/avxl-stock-price-nasdaq-anavex-life-sciences-increases-over-60-pre-market-why-it-happened/
Mark this date: March 26, 2021
ICER review: An assessment of voclosporin and belimumab for the treatment of lupus nephritis.
https://icer.org/assessment/lupus-nephritis-2021/
Ganz, SA is out saying it's CAVA influence because AVXL also has AD program as well. I think it's preclinical but not sure.
You definitely have the Midas touch.
Nice going!
Jess, you make excellent points. It seems virtually ironclad that BP has to be drooling over the prospect of scooping up AUPH.
I really hope you're right about GSK not running afoul of antitrust issues, as they would seem to be the perfect suitor.
I like the following post from an AUPH fan:
It’s clear that this is GIA for now. While many were disappointed I have warmed up to the idea because it could result in far more value then having taken a BO for 40 at approval. The potential is here and significant if they can execute.
It’s all about the numbers now, specifically the new patient prescriptions. That’s it and numbers don’t lie. I have said it for awhile, I believe uptake will be strong as patients diagnosed have been on the sidelines waiting years for a new treatment in a “warehoused” type situation. IMO they priced this as a BP would, for value and patient outcomes. BP would be able to get better pricing in specialty pharma channel to improve margin significantly. It’s all about the new patient prescription trend line now.....
If the other indications you reference come into play, WOW!
I'm glad you mentioned the real purpose of this enterprise: helping the long-suffering Lupus Nephritis patients. For the first time, they can have real hope for a significantly better and longer life.
I don't like to admit it, but in my disappointment of the market reaction thus far, I kind of overlook that sometimes.
Great Lupkynis story- from discovery to approval
28 years in the making!
Voclosporin was discovered in a basement!
https://www.ualberta.ca/pharmacy/news/2021/february/university-of-alberta-adjunct-professor-and-alumnus-discovered-drug,-voclosporin,-approved-by-the-fda-for-novel-oral-therapy-of-lupus-nephritis.html
They are really sending in the clowns
SA article today on Aurinia calls for 120% upside after 5 years, with a peak LN market penetration of only 10%!!!
The title of this hit piece is:
Aurinia Pharmaceuticals' Lupkynis Is Approved - 120%+ Potential Upside In 5 Years
https://seekingalpha.com/article/4403122-aurinia-pharmaceuticals-lupkynis-is-approved-120-potential-upside-in-5-years
This is the author's debut article. Guessing he's very short, maybe only 3'6" or so.
cheers
greggors, the 146M may be too high. Not sure and haven't checked it, but I seem to recall that fully diluted it's 140.5M
Too lazy to research it at the moment
cheers
While there are 126M shares out now, fully diluted I think the number is something like 140M+
Lots of options already out but not yet cashed in, and also lots that have yet to be doled out
Jess, thanks for your candid thoughts- much appreciated.
Have always appreciated your reasoned approach.
For me, this situation reminds me of what Churchill said about the Soviet Union more than 80 years ago:
It's A riddle, wrapped in a mystery, inside an enigma
I really like what you said at the end:
....as I’m firmly sitting in the trench waiting for the BO to happen..
Me too. It's a great value/treasure waited to be unlocked.
Thanks again
Jess, re your msg: From an ST poster prognos....
Same poster this morning......kind of interesting........wonder if you have a take on it.....
I'm wondering if the Koreans and Vietnamese get along with each other in general (and/or historically).......I have zero clue at the moment
08:12 AM
$AUPH
Message to ILJIN: As a great INVESTOR with a good ?? heart, you DON’T really want to REVENGE AUPH’s MANAGEMENT.
If you have tried to REVENGE AUPH’s MANAGEMENT, you really HURT all INNOCENT INVESTORS.
You need to SHOW YOUR LOVE TO OTHERS as a whole.
If ILJIN is a real GOOD person - as ILJIN and I have the same culture in Asia in general, the next life you WILL be RICH again. You also need to help poor people to your own country in Korea. GOOD COMPANY WITH GOOD HEART WILL BE REWARDED MORE IN LIFE AND AFTER DEATH.
PLEASE STOP REVENGE AUPH’s MANAGEMENT ?? ?? THANK YOU!
Reddit is going against Bio-tech shorts
Risky, I don't think AUPH qualifies because the short interest is fairly low here.
The problem here appears to be a big holder that steps on the price whenever it tries to break out
I see two primary theories for the motivation of this person/entity:
1. Revenge- there was an attempted coup attempt a couple of years ago that failed. Some believe the loser is punishing the company and its shareholders for failing to give up control to him/it
2. Control the company by selling to drive the price down, then buying to accumulate more shares, but avoiding the SEC reporting requirements by buying under multiple identities.
If the Redditors/Redditeers were looking for deep value stocks being unfairly manipulated/punished, AUPH would be a good candidate.
I think the story with Aurinia is too complicated/nuanced for them but I would love to be wrong.
Hope we get FDA approval and the 2037 label
Oh yeah.....................
Twilight zone
FDA Approval Letter for Lupkynis (link)
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213716Orig1s000ltr.pdf
FDA Approved Label for Lupkynis (link)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf
BP's greatest friend in a BO is Iljin
By keeping the price depressed, the BO premium is kept artificially low.
I'm thinking a horde of discouraged retail holders might already have (or will soon) given up on holding this.
I think Jess called for something like $20-25 after FDA approval with the 2037 label, and I thought he had it exactly right.
But here we are at a pathetic $16-17
I can't see what changes here until Lupkynis racks up some impressive sales numbers.
Hopefully, they are on the way.
cheers
Re-post of a gem re AUPH (If you don't smile at this I'm surprised)
AUPH.... singing “Oh, you are so beautiful to me” ... those manipulating SP know this is a blockbuster drug. Know it is huge! Mark my words .... if you leave this scared, frustrated (I certainly am frustrated), just plain tired, defeated, given up... then it will become one of your great financial regrets. Your grandkids will be sitting on your knee in your old rented trailer ( no disrespect to trailers as spent more than a few nights in em) telling those grandkids that you were almost rich & telling them at the age of 80 you would not have to head off to work 40 hours a week as a door greeter at Walmart. That grandma wouldn’t have had to still work at McDonalds. Instead of traveling the roads in retirement in a huge beautiful RV, y’all are walking the roads picking up cans.....
I stopped believing in any BO when my buddy from IR sent me the email that I posted.
You might want to re-read that email.
It doesn't say what you think it does.
Your GIA theory is in error. You could benefit by going into the archives and reading (and listening to) every statement by Dr. Glickman.
Glenn even told you (very nicely) as much when he said:
For some reason your query went into the corporate spam folder....
Canadians tend to be very polite.
Do we have any drug pricing experts here?
Wondering the following:
What will the Lupkynis price be in Europe? Will it be a 75% discount to the USA price or ???
Are there any models out there for Europe, Japan, etc. revenues?
TIA for any info/insights, etc.
cheers
Monday's short volume was fairly big- I think more covering should happen
Market Date Short Volume Total Volume Short Volume Ratio
2021-01-27 1,495,154 10,553,600 14.17
2021-01-26 1,939,226 12,340,600 15.71
2021-01-25 7,391,298 35,783,500 20.66
2021-01-22 1,193,867 8,052,000 14.83
https://fintel.io/ss/us/auph