watching biotechs, gold & silver
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
VOS plan for DES. Some clarity was revealed yesterday- next trial will be a Phase 2/3, and it will be against vehicle (placebo) instead of head to head against Restasis.
Here is the transcript:
https://seekingalpha.com/article/4264046-aurinia-pharmaceuticals-inc-auph-ceo-peter-greenleaf-q1-2019-results-earnings-call-transcript
Jess- Thought I would add- LTD and I are Red Sox, Patriots, etc. fans- We both hail from New England area.
cheers
???? Not about politics- I'm talking Red Sox baseball comedy.
It's "Red Sox" and not "Red Socks".
It's "World Series" and not "World Cup Series"
Since soccer is biggest in countries that are not the USA, I'm suggesting the gaffe makers are likely from away and are largely ignorant re "The Great American Pastime", which is baseball.
You've piqued my curiosity however, so I would appreciate hearing from you how you can possibly perceive any politics in my remarks.
Call me a dinosaur, but I really believe this PC world has gone too far- no more jokes, everyone is hyper sensitive, easily offended, insulted, etc.
To me the so called "culture" has gotten extreme and ridiculous.
cheers anyway
LTD- Here's hoping Neil's compensation turns out to be a great bargain when all is said and done here!
Was thinking of you the other day when the Sox went to the WH (at least some of them).
Got a kick out of the WH release that announced the "Red Socks" were coming and the 2nd one that said they had won the "World Cup Series".
Guess the PR dept. there is staffed by foreign interns or ???
cheers
FYI: "Insider Selling: Aurinia Pharmaceuticals Inc (TSE:AUP) Senior Officer Sells 10,000 Shares of Stock"
https://rocklandregister.com/2019/05/13/neil-solomons-sells-10000-shares-of-aurinia-pharmaceuticals-inc-aup-stock.html
"Are FSGS and potential SLE foray fully baked..."
Not even half baked. I don't believe we'll see any value for SLE because:
1. The composition of matter patent for Voclosporin will likely expire or leave so little time it would be a financial loser even if it was effective for SLE, which I don't believe is likely because:
2. I referenced an analysis of the AURA results in msg. #8321 that points out that "when extrarenal elements were assessed alone, the VCS groups tended to have a similar or greater reduction in activity than did the control group (Supplementary Figure S4). For example, the extrarenal SELENA-SLEDAI scores fell 53%, 51%, and 67% in placebo, low-dose VCS, and high-dose VCS patients at week 48,
respectively."
In other words, once Voclosporin has improved the patient's kidney function, the SLEDAI scores are virtually the same as placebo for low dose VCS. So why even bother with expensive and time consuming trials where there is likely no discernible benefit?
3. The SELENA-SLEDAI scoring is subjective anyway, while the great benefit of Aurinia's LN results is they are objective and thus real.
4. The method of use 10 year patent extension won't apply to SLE as it's designed to be added to the label for LN use and treatment.
5. Even if in the unlikely event VCS became approved for SLE, how could the problematic pricing issue be overcome? I see zero possibility an SLE patient would pay $70K annually for VCS.
Re FSGS projected revenues, I didn't figure any value so consider that a bonus.
"...$5B figure is a very nice baseline!"
It's fun to dream! I read somewhere that peak sales for Xiidra are expected to be $1.4B (now 400M) annually.
If true, then NVS just paid approximately 3.8 times peak sales. Wonder what the 400 employees that go with the deal actually do all day?
If VCS for LN is conservatively estimated to generate $1.3B peak sales, then that's a $4B value at just over 3 times peak sales.
If VOS is worth $5B and Aurinia gets all the money that translates into a $81 stock value for AUPH, fully diluted as of today.
Would be nice to see VOS bids from MRK, AGN, and NVS.
Quote from new Novartis CEO re Xiidra and his bullish outlook for eye drugs:
"Narasimhan said in an interview last month that he plans to spend an amount equivalent to more than $10 billion a year on acquisitions and is scouting medicines outside the company, concentrating mainly on nervous system, eye and metabolic illnesses.
Novartis said in April that it expects to launch its drug brolucizumab, a treatment for a form of blindness, by the end of this year. The company has said it’s developing gene therapies, next-generation drugs and other technologies for an array of eye diseases. Xiidra fits into that business well, Hudson said.
“I’ve been looking at this medicine enviously from the sidelines since its launch,” he said."
Quote from following article:
https://www.heraldnews.com/business/20190510/novartiss-53-billion-eye-disease-deal-adds-cash-for-bigger-bets
From SA yesterday: "Aurinia And Voclosporin In Lupus Nephritis: An Update"
https://seekingalpha.com/article/4262832-aurinia-voclosporin-lupus-nephritis-update
Luna, nice one! :) EOM
Why stop at just kidneys?
Shouldn't we all be sending messages to all of our organs?
Could be some interesting messages if that concept caught on.
And short interest jumped up to boot:
4/30/2019 6,902,878
4/15/2019 6,229,895
Are you kidding me? WTF is the deal???
Why didn't the Xiidra sale boost AUPH yesterday?
Here's Xiidra's P3 results- doesn't seem impressive at all.
https://www.ncbi.nlm.nih.gov/pubmed/26365210
Didn't VOS efficacy blow Xiidra's out of the water?
Still amazed that this hasn't jumped up.
An oddity in today's PR/IR release from Aurinia:
"ALL IN™, Aurinia’s educational program and support community for people living with LN, has initiated a new campaign called “Send a Message to Your Kidneys.” Aurinia invites members of the LN community throughout the month of May to submit positive and encouraging messages to their kidneys as a source of strength and inspiration for those living with LN. Visit www.ALLINforLN.com/kidneymessage to submit a message or to view the inspiring messages from others in the community."
Unusual to say the least- not sure what I think about it.
https://ir.auriniapharma.com/press-releases/detail/142
Luna, re: "...their DDI study is being done on SLE patients..."
I thought the DDI is being done with Mycophenolate mofetil (MMF), which I believe is used primarily for LN and only as a second or third line treatment for SLE.
Please advise and TIA
"....Benlysta and Voclosporin scores ...."
What I'm suggesting is this subject is so complex the best approach is to talk to the expert Neil Solomons.
Since cross trial comparisons are dangerous, if you had the numbers they would likely not be meaningful.
Strictly IMO.
Jess, on second thought this is so complex I think the thing to do is to try to talk with Neil for a few minutes and ask him if VCS is possibly a viable treatment for SLE.
This excerpt puzzles me: "At week 48, more than one-half of the subjects in the placebo group (53.4%) still had SELENA-SLEDAI scores >6 compared with 29.2% and 40.9% in the low- and high-dose VCS groups, respectively. Although the improvements in the SELENA-SLEDAI scores were primarily due to improvements in the renal components, when extrarenal elements were assessed alone, the VCS groups tended to have a similar or greater reduction in activity than did the control group (Supplementary Figure S4). For example, the extrarenal SELENA-SLEDAI scores fell 53%, 51%, and 67% in placebo, low-dose VCS, and high-dose VCS patients at week 48,
respectively."
The above is from an article from "Kidney International Organization". Neil Solomons is one of the authors of this excellent piece, which contains a wealth of info on AURA.
https://www.kidney-international.org/article/S0085-2538(18)30628-8/fulltext
"...the latest SLEDAI score for Voclosporin that was said in the conference?"
Neil mentioned that both the high and low dose Voclosporin resulted in a reduction in SLEDAI scores, but his presentation didn't include the slide of the results.
As far as I know, Aurinia is still referencing the SLEDAI scores from the P2 Aura trial.
That slide (#25 of 36) can be found here:
https://seekingalpha.com/article/4064159-aurinia-pharmaceuticals-auph-presents-national-kidney-foundation-2017-48-week-data-aura-lv
"We're in discussions with a number of companies"- Neil Solomons during 1st question during Q&A. The "Q" was re Restasis annual sales (I think Neil said, $1B then around $1.5B).
Neil's response re multiple company discussions re VOS was a response to the questioner asking about talking with Allergan.
Also interesting was Neil's response to a question why the stock tanked after the VOS trial results: Neil said something like "I can't explain why the stock reacted as it did as the drug was extremely successful. Traders perhaps reacted to the headline 'Missed Primary Endpoint'"
Neil also said Aurinia is currently burning approximately $20M per quarter.
Excellent presentation- to hear the replay go to:
https://ir.auriniapharma.com/ir-calendar/detail/1136/2019-bloom-burton-co-healthcare-investor-conference
Another heavy hitter! Wow is right!
"Dr. Billen has more than four decades of experience leading the commercialization of pharmaceutical and biotech products in North America and Europe. Prior to his retirement, Dr. Billen served as Vice President and General Manager, Inflammation and Nephrology at Amgen, from 2011 until 2018. Prior to that, Dr. Billen was General Manager, Amgen Canada, from 1991 until 2011. Dr. Billen previously served in roles of escalating responsibility at Janssen from 1979 until 1991. Dr. Billen received his Ph.D. in Chemistry from the University of Louvain, Belgium.
“Voclosporin represents a potentially significant advancement for patients with life-threatening kidney diseases, such as lupus nephritis,” commented Dr. Billen. “After years of admiring Aurinia’s development of voclosporin, it is an honour to now be joining the Board of Directors and helping to guide this exciting program toward commercialization.”"
Only error is the obvious misspeak/misprint where Dr. Billen's last word in the PR was "commercialization" instead of "a buy out".
Luna, Scifi- thanks for your feedback- much appreciated! EOM
Luna, re Benlysta (belimumab). When approved in 2011, it was forecast to generate as much as $4B within a few years. I believe the price of the drug is approximately $35K annually.
7 years later Benlysta is generating revenues less than $500M per year for GSK, and 94% of that total is in the USA, a far cry from the initial revenue forecasts. This despite a Lupus population of over 500K worldwide.
So I'm wondering if Benlysta's poor revenue is negatively affecting AUPH's market price/value?
Puzzled why AUPH's price is so low here if it truly has blockbuster potential.
TIA in advance for any response.
Scifi, re "strange trading". Guessing you're seeing this on L2 (I don't have).
Wondering if a) this could be somehow influenced/related to options expiration this week or b) LABU (Direxion Daily S&P Biotech Bull 3X Shares) has dropped from a recent $65 to $50???
Any thoughts/input appreciated
Count me dazed and confused. I'm baffled by how this is unfolding, to wit:
They raise $170M + just over 2 years ago at $6.75, shortly after the stock hit $10 +.
Management exhibits nothing short of excellence/brilliance in execution as they add VOS for DES, VCS for FSGS, while exceeding expectations for their P3 trial of VCS for LN.
The reward to shareholders for this outsized management performance? Essentially zilch.
They recently closed out their ATM at a lousy $6.55, cheaper than their earlier raise, despite tremendous forward strides in development.
Their 10 year use patent extension for Voclosporin is just one example of the impressive things Aurina has accomplished.
I'm really surprised we're not at $10+ right now. When does this potential sleeping giant wake up for real?
Beats the hell out of me. Hallelujah anyway!
295,800 shares sold in the after market @ $6.69
Why? Seems very strange
Jess, is this relevant to your warrant/share price question?
"On June 22, 2018, ILJIN SM exercised 88,888 warrants to purchase Common Shares at an exercise price of CAD2.50 per warrant and obtained 88,888 Common Shares of the Issuer, bringing its overall ownership of Common Shares to 988,887 Common Shares. The source used to exercise the warrants were funds available to ILJIN SM from cash on hand.
On June 22, 2018, ILJIN SNT exercised 593,220 warrants to purchase Common Shares at an exercise price of CAD2.50 per warrant and obtained 593,220 Common Shares of the Issuer. The source used to exercise the warrants were funds available to ILJIN SNT from cash on hand.
On February 14, 2019, ILJIN SNT exercised warrants to purchase Common Shares at an exercise price of US$3.2204 per warrant and obtained 145,533 Common Shares. The source used to exercise the warrants was funds available to ILJIN SNT from cash on hand."
Above from 13D filed today (4-8-19)
https://fintel.io/doc/sec/1600620/000110465919020260/a19-7526_1sc13d.htm
"Allergan: Should Saunders Be Fired?"
https://seekingalpha.com/article/4237027-allergan-saunders-fired
More evidence AGN needs VOS
"Silly article:" Maxx (author) definitely phoned it in- I give him an F.
A poorly researched, not well thought out piece- at one point he refers to the "dumb money" (sellers) as the "smart money".
I believe it's his first article on Aurinia, and hopefully it's also his last.
AUPH continues to be the Rodney Dangerfield of the pharmaceutical space; ie., they "get no respect".
Someday it will be different.
LLY drug doesn't seem impressive:
"Results from the trial, which led to the FDA’s decision, showed that more patients receiving the 4 mg baricitinib dose were clear of arthritis or rash at 24 weeks — 67%, compared with 58% of those on 2 mg baricitinib or 53% of those receiving a placebo.
However, patients receiving the active treatment were also more likely to experience side effects — 71% on the 2 mg dose and 73% on the 4 mg dose — compared with 65% of those on a placebo. The rate of serious adverse events was also two times higher among baricitinib-treated patients."
https://lupusnewstoday.com/2018/12/21/fda-gives-baricitinib-fast-track-status/
LLY should seriously consider buying VCS
"Allergan shares fall after company swings to loss and offers soft guidance for 2019"
This may be why we are up today:
https://www.marketwatch.com/story/allergan-shares-fall-after-company-swings-to-loss-and-offers-soft-guidance-for-2019-2019-01-29
RR- Re the "Monopoly" question- FTC definition:
https://www.ftc.gov/tips-advice/competition-guidance/guide-antitrust-laws/single-firm-conduct/monopolization-defined
It's an interesting question. The way I read it, if AGN buys VOS there is no transgression as it would be a result of "business acumen".
The FTC says: "Obtaining a monopoly by superior products, innovation, or business acumen is legal; however, the same result achieved by exclusionary or predatory acts may raise antitrust concerns."
Have to ask you how you see/interpret it?
TIA
The case for AGN buying VOS appears to be substantial.
Allergan certainly realizes that VOS is superior to Restasis and will be approved eventually (and likely could be approved faster with AGN's help).
AGN's #1 and #2 franchises are Botox and Restasis, and both are threatened (by RVNC and AUPH, among others).
Buying VOS now would be a win-win for both AGN and AUPH as Aurinia could focus solely on LN and FSGS and not be distracted with DES which is not really their bailiwick.
A VOS buyout would allow AGN to continue to dominate the growing DES market.
Here's hoping AGN or MRK or another BP make it happen fairly soon.
Allergan (AGN) needs VOS- from today's "New York Times"
"Indian Tribe Joins Big Pharma at the Supreme Court, Defending a Lucrative Deal"
https://www.nytimes.com/2019/01/26/us/politics/allergan-eye-drops-indian-tribe.html
Excerpts:
"Restasis, a treatment of chronic dry eye disease, had sales of nearly $1.5 billion in 2017 — Allergan’s best seller after Botox."
"Restasis sells in pharmacies for an average cash price of about $657 for a month’s supply,..."
That's nearly $8K per year, which seems insanely expensive.
Could be awesome if Allergan and/or Merck contact Aurinia re buying VOS.
Great Tweet from Luna:
@Lunacy_JohnGalt
Replying to @DrBadDoctorMD1 @mhrob @TKTOM
Ok Doc, I'll simplify it. Restasis (Cyclosporine) = toxic = dosing limitations. VOS (Voclosporin) = Less Toxic = less dosing limitations. If they could safely & effectively administer more Restasis (Cyclosporine) they would, but they can't...welcome VOS! $AUPH
When the world figures this out, AUPH should fly.
Jess, re your prior early AUPH buyout hunch:
I'm assuming you still subscribe to that idea.
If so, doesn't AUPH's VOS DES result make that premise more likely?
TIA
I hope the shorts are loading up.
Excerpt from STAT article posted on Tuesday at thefly.com:
"Aurinia CEO says VOS could become blockbuster treatment, STATNews reports Though Aurinia Pharmaceuticals' (AUPH) VOS dry-eye drug trial failed on tolerability, its primary goal, the medicine proved to be more effective -- but slightly less tolerable -- than Allergan's (AGN) Restasis. Aurinia CEO Richard Glickman told STATNews in a phone interview that beating Restasis in efficacy means VOS could become a blockbuster treatment for dry-eye syndrome, saying "We knocked the efficacy out of the park with VOS... We're really excited but I guess I'll need to explain why to the market tomorrow."
I can't help but think that the outstanding/astounding VOS DES efficacy results have been noticed by Allergan (AGN) and other BP's.
Don't a lot of biotech buyouts happen after P2?
Isn't there a good chance that one or more BP's will be contacting Aurinia (if they haven't already)?
Mickey- while it's incontrovertible we live in an often crooked world, I don't think anyone with the stature of an Allergan would be dumb enough to do that.
I also think they're one of the group of likely buyers of VOS.
I attribute it mostly to sloppiness; ie., the article deadline becomes more important than accuracy to them.
I would bet that virtually none of the negative writers actually listened to Aurinia's presentation, Dr. Glickman's explanation of the results and the followup Q&A.
If they did and still blew it, then I would question their intelligence or something else.
VOS is potential game change in DES treatment
"The rapid onset and overall efficacy (as measured by the STT and FCS) demonstrated by VOS in this head-to-head study conducted against Restasis® is astounding and could be a game changer in the treatment landscape for dry eye," said Joseph Tauber, Principal Investigator of the study.
Above quote from: "Aurinia's Dry Eye Syndrome Drug Produces Mixed Results In Mid-Stage Trial".
https://www.benzinga.com/general/biotech/19/01/13015753/aurinias-dry-eye-syndrome-drug-produces-mixed-results-in-mid-stage-tr
IMO, not only were the VOS efficacy results "astounding", but so was the market reaction to it, albeit in a different way.
Another misleading, negative article headline and slant:
"Potential Restasis rival falls short in head-to-head study"
While the author is negative, there are some very positive views presented by more knowledgeable people.
https://www.biopharmadive.com/news/potential-restasis-rival-falls-short-in-head-to-head-study/546545/
Yup- Fake News at it's best. Just sloppy or ???
Claiming "failure" for VOS almost as egregious as the Refs performance at the Saints-Rams game last Sunday.