watching biotechs, gold & silver
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The list you promised: "....many, many Parma and biotechs stocks that had absolutely outstanding phase 2 results only to fail phase 3."
The list you delivered: "22 case studies where phase 2 and phase 3 trials diverged:"
You should already know this, but "absolutely outstanding phase 2 results" means extraordinarily good- what you provided is far from it.
Classic bait and switch- promise something outstanding but substitute something inferior.
A suggestion to help you: Go and learn what the words "absolutely" and "outstanding" mean in ordinary American English.
"...I can list many, many Parma and biotechs stocks that had absolutely outstanding phase 2 results only to fail phase 3"
Let's see that list of biotechs (forget the veal ones).
Not holding my breath.
Jess re "... do you see auph being acquired in the next 12 months?"
I'm neutral on it without a strong view either way- very interesting idea though and your point is a good one; i.e., buy AUPH now at a discount or pay much more after P3 success.
I would think that the recent tax repatriation passage enhances the chances of a buyout sooner because next to tech, pharma is said to have the second highest treasury locked up overseas (I've seen the $250B number used), which creates a big opportunity for biotech M&A to ramp up substantially.
Maybe it makes every potential deal worth more $$$ as well since the acquisition fees are cheaper to the pharma doing the deals with money previously locked up.
Question for you: Somewhere I read AUPH is seeking to build a bigger wall around their IP via seeking patents for the process to make Voclosporin, which apparently already has a barrier as it's said to be difficult and expensive to manufacture. Wondering what others think about that subject?
BTW, congrats on your recent AUPH buy- very astute timing.
"There is something new?"
Nope- just a rerun of old negatives already debunked. The article you referenced was from last June and wasn't a real concern then as now.
Haven't seen a bear case yet that has substance. One could always pop up but I see nothing real on the radar today.
"A lot of FUD today..."
Luna- Happy New Year to you and yours!
Re the FUD barrage re AUPH: It makes sense in the context of trying to knock the price down to buy it cheaper. Fits with the prior advice to sell AUPH at the bottom and the fact that tigers that change stripes are extremely rare.
I expect the torrent of negative AUPH babble to continue or even ramp up. I read it as another contrary bullish indicator.
Thanks again for your highly valued AUPH insights and expertise.
"Very sound approach by the management."
Excellent point. AUPH seems to be the Rodney Dangerfield of bio-land; they get no respect. The dive below $5 in after hours the day of the shelf announcement speaks volumes. Do the sellers really believe they'll raise money at $5? Seems insane.
Is being a Canadian biotech a negative factor? I would think the sellers would look at the AUPH team and give them some credit for their stellar track record.
A year ago this was a gift at $2 and it seems highly likely it's another gift at $5.
I guessed wrong thinking AUPH would be $10 or higher by now. Maybe the likely coming news of P3 full enrollment ahead of schedule will wake up this sleeper.
"Why are investors pulling money out of biotech?"
By DAMIAN GARDE @damiangarde DECEMBER 29, 2017
"Despite soaring stock prices and a few breakthrough new therapies, biotech can’t seem to keep investors enthralled. The flow of money into the sector has turned negative for 2017, marking the second straight year that Wall Street has pulled more cash out of biotech than it has put in.
According to the investment bank Raymond James, biotech is down $59 million on the year. And it could have been worse: If not for one massive week of inflows in June, biotech would be down more than $1.5 billion in 2017, according to Baird analyst Brian Skorney. That’s not as bad as 2016, when roughly $6.5 billion left the sector, but it marks an alarming trend."
from AF's twitter feed yesterday:
"$OMER OMS721 update in-line w/ expectations but what’s the real status of the ph3 aHUS study? Any patients actually enrolled? Any timeline for completion? $OMER doesn’t like pesky questions."
3 Stocks Wall Street Hasn't Heard of Yet
"Tellurian, Aurinia Pharmaceuticals, and Talend are still flying under the radar of Wall Street, and that could be your opportunity."
MF starting early in 2018 being bullish on AUPH
https://www.fool.com/investing/2018/01/03/3-stocks-wall-street-hasnt-heard-of-yet.aspx
"Biomarker Predicts Lupus Nephritis Flares"
Excerpts:
"And in a longitudinal analysis, high levels of C4d in conjunction with anti-ds-DNA autoantibodies, was significantly predictive of future lupus nephritis."
"Clearly, there is still a need for a biomarker that would predict lupus nephritis so that preventive measures could be initiated as soon as possible," the investigators said. "C4D levels are more valuable than either C3 or C4 in predicting recurrence of renal flares, aiding clinicians in adjusting treatment in time."
For some odd reason, the following link (which is correct) doesn't always load if you click on it- if you get a 404 error (not found), to read the article copy the link address and open in a new tab or window. It may take several attempts as that fails sometimes as well.
https://www.medpagetoday.com/rheumatology/lupus/69732
SA-"3 Reasons To Buy Aurinia Pharmaceuticals"
Summary
Voclosporin, a potential blockbuster drug, revealed convincing phase 2 data for treatment of lupus nephritis and is being piloted toward dry eye disease.
CEO Richard Glickman is a perfect match for Aurinia.
Aurinia is funded through 2020 and significantly undervalued.
https://seekingalpha.com/article/4127547-3-reasons-buy-aurinia-pharmaceuticals
The deal is that you saying "We" indicates you are claiming you are long and we all think you are not. Display your brokerage statement and Abe's eye guy's credentials and we'll reconsider.
"...we will be deep trouble..."
You're dead wrong- we're being handed a gift. Look at the bright side- you're still batting 1000- always wrong.
We already know that- need the info on Abe Lincoln's eye doctor.
"That was a real doctor..."
Then it should be a simple matter to post his bona fides.
I'm from Missouri- show me.
"Moose, you need to visit the doctor on Twitter..."
"The problem with internet quotes is that you cant always depend on their accuracy" -Abraham Lincoln, 1864
" Even with the high price tag, insurance companies with be happy to pay for it compared to hospitalizations, dialysis, transplant surgery, etc."
Excellent point- thanks for your analysis- right on point as always.
So glad you are here and always so generous with your input.
Luna- Thanks again. I failed to express my question clearly and accurately.
What I'm wondering about is the following scenario: In the case where MMF is working well for someone with LN, is the superiority of adding VCS enough to make them switch when the additional relatively high cost is considered?
Or is it a non-issue because insurance will pick up the tab?
I realize this is essentially unknowable, but just wondering what your view is.
Thanks for all the help.
"...there is a generic now that is much cheaper."
Thanks for the cost info on CellCept. Wondering how many will switch to VCS since the price disparity will be so high?
Any feedback appreciated.
Does anyone know what CellCept costs?
This from Ronald Liu on Twitter:
"$AUPH Roche made $2 billion USD in 2008 from CellCept sales alone! That sure made up for the Aspreva purchase of $915M. WOW!"
That number is somewhat misleading as the indication listed is "transplantation"
Wondering what the off label use is for LN?
I predict cervelo will respond "Indeed"
He will not like Cramer's latest on AUPH:
Aurinia Pharmaceuticals Inc. : "We kind of like it. We like it. But remember: really risky and long term."
https://uk.finance.yahoo.com/news/cramer-apos-lightning-round-apos-224700380.html
"...don’t you like cartoons?"
One of the best things in life! Very happy to see the baseball team named after the Jetson's dog just won the World Series.
Always thought it would be fun to have a dog like that, a van and some friends to travel around in and solve mysteries.
cheers
"...you’re a funny guy BR."
Indeed. I'm guessing what keeps the board from hitting the ignore button is knowing all the comedy they would miss out on.
"...your link is all about the pH 3 trial; nothing on new indies"
How did you miss post 5944? DES maybe?
Here it is below:
*Nice summary Luna- thanks!
"Aurinia is no longer just an LN focused company. Exciting news was released during the recent R&D day about venturing into new areas of interest. Overall this takes even more risk out of an already derisked clinical stage bio company while adding both short & long-term value to shareholders.
AUPH UPDATES:
AURORA LN TRIAL:
-Single Phase 3 trial (Duplicate of Ph2B)
-113 recruiting sites around the world and counting
-Expected completion date 2H-2018 & Top-line results expected 2H-2019
-Rolling NDA Submission 2H-2018 due to Fast Track Approval
-Conservative annual LN revenue: Approx. $1.4 billion
Oct. 20th R&D Day unveiled new exciting catalysts
-FSGS & MCD (Focal Segmental Glomerulonephritis & Minimal Change Disease)
-FSGS & MCD are causes of Nephrotic Syndrome
-Approx. 150,000 patients globally
-No approved treatments
-Reliant on off-label steroids and legacy CNIs (Cyclosporine)
-Ph2 POC trial expected 1H-2018 (Interim data release 2H-2018)
-Nephrotic Syndrome is an important unmet need
VOS (Voclosporin Ophthalmic Solution):
-VOS is a new nanomicellar aimed at treating DES (Dry Eye Syndrome)
-Market size is > 20 million patients in US along
-Improved potency, dosing, and tolerability compared to current standard of care (Restasis)
-Completed Ph1 human trial with small sample but promising efficacy vs. Restasis
-Licensed out VOS for canine use to Merck and completed animal studies
-IP to approx. 2031
-Ph2A trial to be conducted in 1H-2018 (H2H vs. Restasis)
-Low risk high reward opportunity
-2H-2018 AUPH will look to monetize VOS or conduct Ph2B"
north- Thanks for all the input re DES. Very informative/interesting material.
I need to learn more about this- clearly not exactly a straightforward subject.
"...as long as no SAEs show up in the P3 trial.."
You're setting yourself up to be disappointed.
My understanding is that SAE's always show up in every Lupus trial, so I fully expect them to appear in this one as well.
While I believe that miracles happen I would guess the odds are astronomical against zero SAE's happening.
I think the important thing is the number of SAE's vs. the SOC (Cellcept), which should be favorable looking at recent history.
"...it is too early in its development."
I didn't expect AUPH to immediately double, but really didn't expect it would head south in a big way either. Thought it should have jumped $1-2 and think we should be at $8-9 here based on all the good news.
Also, looking at the number of enrollment sites it wouldn't be surprising if full enrollment for P3 happened in 10 months vs. what I think was projected to be 12 months.
Bottom line for me currently is that the fundamentals of AUPH are improving so the stock should eventually follow.
"AUPH's compression level has been pushed past what a coil spring could handle."
Have to hand it to the manipulators- they are very clever. The conspiracy theorist within wonders if Duggan sold cheap to re-buy (add shares) even cheaper.
"It is a whole different reality down there." I'm looking forward to a different reality so really hoping P3 hits.
Thanks for your thoughts and the Scuba tropical destinations R&R suggestion- nice that age is not a real barrier to the sport. Adding it to the bucket list.
north- Thanks for your comprehensive post re DES- much appreciated. You stated "There are ~ 3 kinds of DES for which EPA or any other medication may, or may not, always be suitable".
Didn't realize DES was so complex. Are you saying/suggesting that VOS can't compete/surpass Restasis in sales as it will be used for a different form of DES?
Related question regards the Merck "Doggy DES" market. I think I read somewhere that 5% of dogs in USA have DES so was thinking that since America loves to pamper it's pooches that market could be pretty big.
Thanks again for your post.
H.C. Wainwright raised its price target on Aurinia Pharmaceuticals (NASDAQ: AUPH) to $12.00 (from $10.00)
https://www.streetinsider.com/Analyst+Comments/Aurinia+Pharmaceuticals+%28AUPH%29+PT+Raised+to+%2412+at+H.C.+Wainwright%3B+R%26D+Day+Showcases+New+Indications%2C+Expanded+Opportunity/13436530.html
Hey, what am I missing/not understanding here? If VOC for LN has a $1.4B world-wide market potential and DES is already a $4B market with the SOC (Restasis- market leader from AGN) nearing the $2B mark on a drug that appears inferior to VOS, why isn't the price of AUPH jumping???
I don't get it. Baffled in Bio-land.
"Roche, Genentech Now Recruiting Lupus Nephritis Patients for Clinical Trial Testing Gazyva"
Is anyone familiar with this drug (Obinutuzumab)? Any help appreciated.
https://lupusnewstoday.com/2017/10/26/lupus-nephritis-patients-being-recruited-for-clinical-trial-of-gazyva/
"Restasis is doing about $2b per/year and growing"
That's roughly 1/2 the market according to these guys:
https://market-scope.com/pressrelease/dry-eye-products-market-expected-to-generate-4-5-billion-by-2020/
They claim that:
"The global dry eye market is dominated by three companies that collectively account for nearly 82 percent of total revenues: Novartis/Alcon, Allergan, and Santen."
I'm assuming that Restasis is superior to the Novartis and Santen drugs- wondering if you are familiar with their products also?
Thanks for any help
Have a great weekend
"...looks like Auph is intent on selling off VOS..."
Does VOS have the potential to be worth $2-$3 B, assuming it's superior to SOC?
Thanks in advance
Thanks. BTW, have been meaning to ask you: re your scuba diving, price compression analogy, is that identical to the "coiled spring" analogy?
Will be nice when this spring stops acting like a slinky.
Never have been a diver but looks like big fun- maybe someday.
" I don’t know how you can retire with that strategy. "
Maybe he always does the opposite of everything he says so that "SELL" really means "BUY".
Bob Duggan reduced his Aurinia stake
2017-10-23 SC 13D/A DUGGAN ROBERT W 5,766,887 4,912,284
https://fintel.io/so/us/auph
Would think he would be adding instead- surprising twist to the saga.
https://ir.auriniapharma.com/sec-filings-email/content/0000921895-17-002488/sc13da106922aur_10232017.htm
"...BR's gonna have a ball with today's post market action.
You mean the 13,917 shares that traded in after hours?
Are you suggesting he'll claim that massive volume is more evidence of institutions dumping?
I speculate even he wouldn't make such an outrageously ridiculous claim.
"It is a mystery after a great investor’s day...."
Indeed. All I truly know is that the value of Aurinia is going up while the price is going down so those that think like Jess and can act on the mystery are going to be rewarded.
Wish I could have a few beers while hanging out with Bob Duggan, and/or listen in via speakerphone to the pre-market conference calls of the guys who are running the price up and down, assuming they collude with each other.
Definitely a wild ride with an outstanding risk/reward ratio attached at present.
"Amgen’s AMG 811 Fails to Improve Lupus Outcomes in Phase 1 Trial"
This disease is a brutal mystery- Aurinia is going to help a lot of people who are suffering.
https://lupusnewstoday.com/2017/10/17/amgens-amg-811-fails-to-improve-lupus-outcomes-in-phase-1-trial/
Nice going! Vid, TC, Luna, you, and all the other early investors are to be congratulated on your early confidence before the price exploded upwards.
Wish I could say the same, but still expect to do well with this one- I am impressed with Vid's statement that in 20+ years of experience in biotech this is the best opportunity he's witnessed to date.
Late to the party is still better than never attending. Hope to meet you all in person in Vancouver at some future date.
Best of luck to you