watching biotechs, gold & silver
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Bristol Myers Squibb: Still On Track
Mar. 19, 2022 8:40 AM ET
Bristol-Myers Squibb Company (BMY)
Summary
Despite facing a steep patent cliff, BMY has one of the largest pipelines of the US pharmaceuticals. Recent and upcoming launches should replace lost revenue to support continued modest growth.
The market is overly focused on upcoming patent cliffs and undervaluing the pipeline.
Strong cash flow enables BMY to pay off debt incurred from recent Celgene and MyoKardia acquisitions, as well as offer shareholder returns.
https://seekingalpha.com/article/4496603-bristol-myers-squibb-on-track?mailingid=27087168&messageid=must_reads&serial=27087168.1300418&utm_campaign=Must%2BRead%2BMarch%2B19%2C%2B2022&utm_content=seeking_alpha&utm_medium=email&utm_source=seeking_alpha&utm_term=must_reads
Cosa, Thx for the heads up. I have very limited (almost zero) experience with options, but these times are so unusual and the price here is so distorted I'm thinking/pondering it.
Happy Saint Patty's Day to all!
Slainte!
Secondary Analysis of BLISS-LN Reveals Exciting Findings for Lupus Nephritis
https://www.rheumatologynetwork.com/view/secondary-analysis-of-bliss-ln-reveals-exciting-findings-for-lupus-nephritis
Cosa, which 2024's? TIA
I think useless- Here's Klaus a few hours ago- "We only hope that — in the longer-term — reason will prevail and that the space for bridge-building and reconciliation once more emerges."
He might as well have said- "I'm looking forward to being friends with Putin again".
After Putin invaded Crimea in 2014, Klaus invited Putin to speak at Davos.
Lousy principles, IMO
Xi's Mom is alive (95). As soon as she passes, I say Xi moves into Taiwan.
Putin's Mom has passed- if she were alive today she would probably would have killed him before now.
If only those 2 Mom's knew what future monstrous murderous thugs they had brought into the world, they could have snuffed them out in their cribs and saved the world a lot of undeserved pain and suffering.
What evil, rotten, worthless bastards!
It's nice Peter didn't go for the options at $9.97- raw greed is not an attractive quality.
Does anyone know when the nominations open for "Worst Biotech CEO of the Year"?
Through somewhat unusual circumstances I believe I've stumbled upon a really strong contender to win that crown.
Hallelujah anyway!
Cheers
SVB Leerink cuts AUPH PT from $30 to $22
SVB Leerink reiterated coverage of Aurinia Pharmaceuticals with a rating of Outperform and set a new price target of $22.00 from $30.00 previously
https://quantisnow.com/insight/2536352
That Swiss based group owns under the 5% reporting threshold, so I believe that they get to remain anonymous (no 13D's, etc).
They've got my curiosity- just adding that to the numerous mysteries, puzzlements of this situation.
cheers
Aurinia Pharmaceuticals gains on report investors pushing for sale
Aurinia holders, led by Switzerland-based MKT Tactical Fund, have written to the AUPH chairman, asking the board to hire a bank for a sale process, according to a Betaville "rare alert." The investors own just under a 5% stake in AUPH.
https://seekingalpha.com/news/3810237-aurinia-pharmaceuticals-gains-on-report-investor-pushing-for-sale
5 hours ago —Watching Aurinia Pharma Shares Amid Speculation From Publication Betaville A Europe-Based Investor Group Is Pushing Co.'s Mgmt. To Consider Strategic Alternatives
https://www.benzinga.com/news/22/03/26019808/watching-aurinia-pharma-shares-amid-speculation-from-publication-betaville-a-europe-based-investor-g
Despite Market Reaction, Aurinia Pharmaceuticals Is On Track And Ahead Of Schedule
according to an Amit Ghate, who authored a SA article dated today:
https://seekingalpha.com/article/4493314-aurinia-pharma-stock-on-track-and-ahead-of-schedule?utm_medium=email&utm_source=seeking_alpha#comments
ILJIN ownership looks like just under 6%
https://fintel.io/so/us/auph
2022-03-03 13D/A ILJIN SNT Co., Ltd.
Previous Shares 8,995,439
Current Shares 8,277,800
Aurinia faces choppy waters amid lower-than-expected 2022 guidance and patent challenge on Lupkynis
Beth Snyder Bulik
Senior Editor
from 'Endpoints News' March 3, 2022 01:09 PM EST PharmaFDA+Marketing
A new patent challenge to Aurinia Pharmaceuticals’ lupus nephritis drug Lupkynis is adding to the biopharma’s woes this week. Sun Pharmaceutical is challenging Aurinia’s “treatment protocol” patent, the company revealed in a 10-K filing this week first reported by STAT.
Aurinia pushed back on the news report, pointing out, in a statement to Endpoints News, that the patent has already been through “significant review” with the US Patent and Trademark Office before Lupkynis was approved by the FDA in January 2021.
“We are confident in our process to prosecute all of our patents. We’re putting together our reply and will vigorously defend this patent and any other challenges that any party may bring to any of our patents,” Aurinia said.
Sun’s intellectual property challenge was filed Feb. 24 with the USPTO’s Patent Trial and Appeal Board. It asks for an inter partes review (IPR) on claims it presented as reasons why “the ’036 patent are not patentable.” Lupkynis’ ‘036 patent is a specific dosing and administration schedule, granted by the FDA on the drug’s label, that extends the drug’s exclusivity to 2037.
Lupkynis’ original drug patent is set to expire in 2027, but the dosing approved and included on its label is key to extending the drug’s exclusivity out for 15 years.
In the wild and woolly world of drug patents, this is not the first entanglement for Aurinia and Sun around voclosporin, the generic name for Lupkynis.
Aurinia was studying voclosporin ophthalmic solution (VOS) as a dry eye treatment but dropped development of it in 2020 when VOS did not meet Phase II/III primary endpoints.
Fast on GlaxoSmithKline's heels, Aurinia wins OK to steer a second lupus nephritis drug straight to the market
However, Aurinia is suing Sun and its Cequa dry eye medicine approved in 2018 over two patents from its voclosporin ophthalmic solution. Aurinia revealed the suit in December 2020 claims Sun’s dry eye med Cequa, or cyclosporine, infringes on two of its patents and is asking for an injunction to stop Sun from selling Cequa and monetary relief including cost. Sun has denied the charges and said the two patents at issue are invalid. That case is expected to go to trial in March 2023.
Lupkynis was approved to treat lupus nephritis in people with systemic lupus erythematosus. About 40% of people with lupus will develop the kidney inflammation condition. Its chief competitor is GlaxoSmithKline’s Benlysta, an existing lupus treatment that got a nod for lupus nephritis the month before Lupkynis was approved. Aurinia is working with Otsuka outside the US to market Lupkynis and expects European approval in the second half of 2022.
Bloomberg reported last year that Bristol Myers Squibb was eyeing Aurinia as a takeover target, however, Stat’s new report cast doubt on the smaller biotech’s attractiveness to suitors (it named Biogen as another) with the patent cloud now overhead.
Still, it’s been a tough week for Aurinia which was already dealing with a declining stock price after its fourth-quarter report on Monday resulted in analysts dropping forecasts for the year. While sales for 2021 and Q4 were on target at $45.5 million for the year, Aurinia’s lower-than-expected sales forecast for Lupkynis in 2022 caused analysts to drop estimates and stock price targets. Aurinia projected Lupkynis sales of $115 to $135 million for 2022 which was considerably lower than industry consensus at around $180 million.
After passing on Acceleron, Bristol Myers eyes bolt-on acquisition of autoimmune specialist — report
SVB Leerink laid out the issue as a potential disconnect between management and the Street, pointing to its own healthcare conference in early February where Aurinia told analysts to expect “aggressive numbers.”
As SVB Leerink wrote in a Q4 earnings note Monday:
When we asked AUPH about these prior comments on the call just ended, management noted that 150-200% YoY growth is worthy of the term aggressive. This divergence from consensus reminds us of the first couple quarters of Lupkynis’ launch when management was focused on the longer-term trajectory, rather than the initial ramp which was the focus of investors.
Oppenheimer analyst Justin Kim also tackled the disconnect explaining its stock price target cut to $18 from $31. He wrote that “consensus estimates (including our own) perhaps now unrealistically relied upon commercial inflection over steady incremental growth.”
2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs
(Listed by date of FDA approval; Lupkynis is #3 in this list)
https://www.fiercepharma.com/special-report/2021-s-new-drug-approvals
Can you think of a legitimate reason why PG would want to drop the price?
That seems to be his goal, based on his recent actions.
1. They file a shelf but claim no need for funds.
2. He claims "aggressive sales projections" are soon to be unveiled.
3. He releases a very weak 2022 sales forecast.
4. We discover they raised $200M via ATM that they claimed prior they didn't need.
Disappointing, to say the least.
If this post is accurate, PG has some explaining to do:
cageybee
$AUPH
This morning, I emailed the following to Aurinia's business development unit. It's based on my concern (disgust, actually) with the lackluster sales forecasts that PG recently released and the utter lack of effort to use digital marketing to get the word out about Lupkynis:
"I manage my family's investments and made the decision years ago to make a substantial investment in Aurinia, based on the promise and potential of Lupkynis. The company's most recent projections of meager sales growth has me livid, frankly. I have read numerous anecdotal accounts of physicians who are completely unfamiliar with Lupkynis, which by this time is unacceptable from a marketing perspective.
Patients suffering LN, like others with debilitating diseases, want to learn about their treatment options, and turn to the internet for information. This morning, I Googled "lupus nephritis" and was disappointed to find that Lupkynis did not appear at all within the first ten (10) pages of the search results. It may have been further down the line, but I stopped looking. After all, who looks 10 pages into a Google search?
Why isn't Lupkynis on the first page of the search terms for LN? It should be. Aurinia needs to make sure that someone searching the internet about LN will find Lupkynis easily, so they can ask their treating physician about it.
Consider engaging an outside marketing firm to help Aurinia achieve page 1 placement on Google's LN search results. This can be done easily and relatively cheaply using search engine optimization (SEO) techniques that build a robust internet presence on Google, other search platforms and across social media.
It is a shame that more LN sufferers do not know about Lupkynis. It is inexcusable that treating physicians do not.
Effective internet marketing is a critical step toward sales growth and may just be a godsend for LN sufferers looking for help. Step up and fill the vacuum of information about Lupkynis."
Long-winded, yes, but the company's internet presence is nil. That's inexcusable!
AF's initials are backwards- It's FA and the
F stands for "Flaming"
cheers
The current price seems so stupid that maybe Aurinia should take the $200M they raised at $20 and buy back their own stock.
Some interesting remarks re the AF hit piece today:
@TheMach99
Replying to
@AdamSinger
$auph 036 patent is stronger than the NVS Gilenya dosing patent. Sun will need to provide clinical safety and efficacy in LN. This unlikely to get past the petition phase.
Replying to
@adamfeuerstein
I think I was the first one on the scene reporting the patent challenge. I am not sure how much the news challenges the $AUPH takeout hopes. The Markman Hearing / Opinion to be held in the next 2 months and issued shortly after is the next key milestone.
biostockGuru
@biostockguru
Replying to
@sentivcapital
Some important information here is that $AUPH was suing Sun Pharma first. It's fairly common for parties to counterattack the other by trying to invalidate their patents. This is intended to put pressure on $AUPH, but it doesn't mean Sun has a case.
Just when you think it can't get worse- AF goes negative
'Aurinia Pharma’s takeout hopes dim with new legal challenge to key drug patent'
Adam Feuerstein
By Adam Feuerstein March 2, 2022
https://www.statnews.com/2022/03/02/aurinia-pharmas-takeout-hopes-dim-with-new-legal-challenge-to-key-drug-patent/
'H.C. Wainwright analyst Ed Arce lowered the price target on Aurinia Pharmaceuticals (NASDAQ: AUPH) to $33.00 (from $40.00)....'
March 1st, 2022 9:30 AM EST
Royal Bank of Canada lowers AUPH price target from $31 to $27
(3-1-22)
'RBC Capital reiterated coverage of Aurinia Pharmaceuticals with a rating of Outperform and set a new price target of $27.00 from $31.00 previously'
https://quantisnow.com/insight/2495814
(from ST)
Spoiler Alert- Today's Wordle is prophetic:
Solution today is 'CHOKE'
Rarely have so many flabbers been so gasted.
What's next?
Apologies for the double post- fat finger I guess
Interesting 1 year chart BR- seems to clearly depict someone is giving (and getting) the middle finger.
My question is who is the giver and who is the receiver?
cheers
Interesting 1 year chart BR- seems to clearly depict someone is giving (and getting) the middle finger.
My question is who is the giver and who is the receiver?
cheers
On Nov 2 AUPH closed at $32, and has been cut in half.
On the same date, BMY closed at $58, and today is $68.
Bristol now is worth $20B plus more than on Nov 2nd!!!
The lack of money to buy AUPH is clearly not an issue!
Had to check in here- hanging on during this insanely wild ride!
My wife's recovery is coming along, but more slowly than we both anticipated.
Hoping all is well with you guys, and also hoping WW3 has not started.
Sort of surprised during the 'Peter Principle' exchanges nobody exclaimed "What a Dick!"
Couldn't resist, but recognize it's probably a TOS violation.
Best to you all,
Cheers,
Hallelujah anyway!
Jess,Ganz,BR,thesaud,Zeppo,et al.,
You guys are the best! Thanks to you all so much for the very kind and heartfelt sentiments!
You all really get what's truly important!
That realization hit home to me during the 4+ hours of living hell as I waited for the outcome. I can't remember ever being so scared in my life! As I was chasing the ambulance en route to the hospital, the surgeon called me to say he needed my verbal approval as this was a critical situation with no time for any paperwork. He said her stomach and pancreas had strangulated and were dying, and that he hoped he could save them and her. He did!
As I waited for hours in limbo, I couldn't help but review my life, and it really hit me how I have wasted so much time- not only missing the present but often instead either beating myself up for past foul-ups or worrying about the future that often is out of our control.
And to add to that folly, most of that stuff is really trivial compared to what's truly important!
My wife and I are just so grateful and reminded just how fragile and fleeting life really is!
God Bless You All!
Thanks again for your kind concern!
I love you guys!
Haven't read the board since May- had a life-changing event occur which necessitated a timeout for me.
Just read back a couple of weeks and really enjoyed all of the speculation, opinions, forecasts, comedy, etc. re the current market drama with Aurinia.
On one post I saw a recent Canadian Motley Fool article referenced, but without the link posted.
If you didn't see it before, here's an excerpt with the link to it:
'Aurinia is now a top stock for those seeking to retire early'
https://www.fool.ca/2021/08/16/retire-early-ignore-top-stocks-and-buy-this-instead/
PS. Personally, I'm extremely grateful to the American Medical establishment! In a nutshell, my dreamgirl/sweetheart/spouse of 40 years experienced an extremely rare medical emergency and survived a 4 hour plus emergency surgery. Thank God for her extraordinary surgeon. She is on the mend, about halfway through a 6-8 month recovery. Her outlook is very good.
Thanks for making this board so informative and entertaining!
Best to you all,
cheers!
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") today announced that it will release its first quarter 2021 financial results on Thursday, May 6, 2021, after the markets close.
Aurinia’s management team will also host a conference call at 5:00 p.m. EDT to discuss the Company’s financial results and to provide a general business update.
https://finance.yahoo.com/news/aurinia-pharmaceuticals-release-first-quarter-103000787.html
London Times says GSK or AZN may take out AUPH
https://seekingalpha.com/news/3692192-aurinia-pharmaceuticals-gains-on-takeover-speculation
Thanks nferna!
cheers
One could think that other major insurers will follow suit.
The Billion $$$ question!
Your entire post is dead on target!
Hope someday those ignorant, arrogant, useless ICER bastards become extinct.
Their final LN report was and is a travesty of distortion, falsehood, etc.
That they would work overtime to deliberately mislead the LN community is just evil.
Apparently, they hate LN patients, their doctors, and maybe also Canadians.
It's particularly galling ICER is so brazen they evidently think they can fool the nephrologists, rheumatologists, and the LN patient advocates.
They are truly twisted, sick, etc.
'Physician, Heal Thyself' comes to mind.
Despite them, Aurinia is looking good!
Wondering if that is the technical description of "active LN".
Naturally hoping it means something broader.
Good news either way, as Cigna is one of the 'big boys'
cheers
Re Cigna coverage for Lupkynis: What does section "ii" mean?
Cigna covers voclosporin (Lupkynis) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence:
1. Lupus Nephritis. Approve for the duration noted if the individual meets ONE of the following (A or B):
A) Initial Therapy. Approve for 6 months if the individual meets ALL of the following conditions (i, ii, iii, iv,and v):
i. Individual is ≥ 18 years of age; AND
ii. Individual has autoantibody-positive systemic lupus erythematosus (SLE), defined as positive for antinuclear antibodies (ANA) and/or anti-double-stranded DNA (anti-dsDNA) antibody;......
TIA for any clarity on the above
https://static.cigna.com/assets/chcp/pdf/coveragePolicies/NPF/npf_656_coveragepositioncriteria_lupkynis_pa.pdf
.....with my resume in business and management success!
Don't be so modest- a resume is far too short for someone with your credentials and track record.
I'm sure the board would rather you post at least the first 20 pages or so of your CV.
I'm also nearly certain we would all be most interested in seeing it.
If it's not too much, a short list of books, people, etc. that have inspired your achievements would also be interesting.
Billionaire genius fund manager Steve Cohen likes AUPH
It's on a list of his Top 10 Small Caps
Here's the list published today:
https://finance.yahoo.com/news/billionaire-steve-cohen-top-10-141809732.html
Nice to see that one of the greatest investors in history sees the value here.
cheers
PS. He also likes AMRN (#7), but #1 and #2 are BCRX and AXSM
A reminder just how great LUPKYNIS (voclosporin) is:
(also courtesy of Michel Nantel)
https://www.renalandurologynews.com/home/news/nephrology/lupus-nephritis/voclosporin-calcineurin-inhibitor-treats-proteinuria-membranous-proliferative-lupus-nephritis/
Too bad the ICER clowns ignore the glaring truth; ie., Aurinia's LN drug blows GSK's out of the water. Not even close.
So what is ICER's and GSK's recommendation for the hypothetical where someone is on Benlysta for SLE and they develop LN?
I guess their advice would be: "Keep taking Benlysta".
The insanity/stupidity is truly mind-boggling!
cheers