watching biotechs, gold & silver
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ttubular- Re the 2037 patent (036): This is from the 4th quarter earnings call on Feb 28, 2022:
Aurinia Pharmaceuticals Inc.'s (AUPH)
CEO Peter Greenleaf on Q4 2021
Results - Earnings Call Transcript
Feb. 28, 2022 10:27 AM ET |
Maury Raycroft
Got it. Okay. And maybe just quick question, in your 10-K, you note that Sun filed
an IPR against your 036 patent. And I'm just wondering if you can comment on your
latest thoughts on IP positioning and also this particular issue?
Peter Greenleaf
Sure. And let me actually take a minute to address this one. I want to thank you for
the question. We did receive notice of an inter partes review, or IPR, petition being
filed on February 24 with respect to our patent that has claims directed at
LUPKYNIS dosing protocol for lupus nephritis used in our clinical trials.
As you all recall, that patent has a term extending out to December of 2037. At this
stage, it's really too preliminary to give a full assessment of this IPR as a position --
a petition that was filed from Sun Pharmaceuticals who you all may recall, if you've
been reading our Ks, we are suing for patent infringement in a separate matter,
which I'll talk about in a second, was really just received.
So we're looking at it, but we're confident in our process to prosecute all our
patents. This patent in particular, had significant review, as we've mentioned
previously at the U.S. Patent and Trade Office before being approved as being
actual valid patent by that office. We're putting together our reply. And as I've said
before, we'll vigorously defend this patent and other challenges we get, again, from
any party that bring any challenge to our patents.
With respect to the separate litigation we have with Sun that I just mentioned, and
as has been disclosed in our 10-K, in December of 2020, we actually commenced
on an action in the U.S. District Court, New Jersey against Sun and certain of their
affiliates, and in summary, the action is a claim for patent infringement under U.S.
patent laws arising relating to Sun's CEQUA product, which is a C&I
immunosuppressant ophthalmic solution prior to the expiration of our patents
relating to voclosporin's ophthalmic solution.
So basically, in our action, we requested relief in the form of an order confirming
that Sun has infringed those patents and injunction preventing Sun for
manufacturing, using or selling CEQUA and monetary relief, including costs.
Obviously, Sun has responded by denying infringement and/or asserting that the
patents here are valid. We and Sun actually have exchanged initial pleadings and
patent disclosures, and we're in the process of what lawyers qualify as claim
construction, and that's all ongoing. Trial action on this one is probably somewhere
on or around March of 2023. So that gives the full backgrounder on the previously
mentioned Sun litigation and the IPR side of the equation.
Maury Raycroft
Got it. Okay. That’s helpful. Thanks for taking my questions
Why no deal has been done or will be done until.....
Probably every stockholder has a BO theory.......here's what I think at the moment:
Nothing happens until the 2037 patent issue is resolved because the stakes (values) are too big until a verdict is rendered.
True enough that Lupkynis has been slow out of the gate, but it easily could become a $1B plus drug over time. The key to obtaining a high value therefore lies in securing a long patent life, which gives Lupkynis time to become SOC, etc.
BP doesn't want to pay big $$$ if the 2037 patent extension is thrown out, and AUPH doesn't want to give this wonder drug away for chump change, which is what I'm guessing BMY offered.
FWIW
GLTA
Gotta love the comedy- my favorite post today:
https://stocktwits.com/hashtagzee/message/469584389
..this was in a more difficult to treat refractory population .
..the KZR trial achieved similar results without induction therapy and in a tougher to treat population
The above two claims don't seem to add up..........
Refractory lupus nephritis, broadly defined as failure to attain clinical remission after appropriate induction immunosuppressive therapy
https://www.dovepress.com/management-of-refractory-lupus-nephritis-challenges-and-solutions-peer-reviewed-fulltext-article-OARRR
It also seems odd that the KZR trial started out as blinded but then was switched to open label. Isn't bias inevitable?
So his comparison chart is misleading at best
It sure is misleading, but not in a good way for KZR:
They had several dropouts for adverse events but failed to include them in their response stats.
The numbers KZR are claiming as response rates in that trial are inaccurate (too high), thus very misleading.
Mean daily prednisone background dosage was reduced from 19.2 mg at baseline to 9.1 mg at EOT and was further reduced at Week 29.
How does anyone separate the impact of Zetomipzomib from that of the prednisone?
It seems like it will take something substantially more than a small open label study to know.
That could take awhile.
https://ir.kezarlifesciences.com/news-releases/news-release-details/kezar-life-sciences-announces-positive-topline-results-mission
Doctors try to keep the dose of steroids as low as possible in to order to reduce the risk of side effects.
Kezar's phase 2 lupus data spur hope for former pipeline-in-a-drug contender—and a share rally
https://www.fiercebiotech.com/biotech/kezars-phase-2-lupus-data-keeps-hope-alive-former-pipeline-drug-contender
Always a pleasure to read informative and insightful missives.
Erudite and on target posts are too rare.
cheers
Another take on KZR results:
https://twitter.com/Sue_S_E_N/status/1541571625790980099
Re KZR results comparison from LordDragon:
$AUPH You be the judge….🤓😏 pic.twitter.com/5I3teu6RxS
— LordDragon (@IamLordDragon) June 28, 2022
This article is worth a read: Opinion: Seven reasons the beleaguered biotech sector is now a ‘buy’
https://www.marketwatch.com/story/seven-reasons-the-beleaguered-biotech-sector-is-now-a-buy-11655475446
FTC Launches Inquiry Into Prescription Drug Middlemen Industry
Agency to Scrutinize the Impact of Vertically Integrated Pharmacy Benefit Managers on the Access and Affordability of Medicine
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169081715
Lupkynis vs Benlysta for Lupus Nephritis
What do you think? TIA
https://www.lupusencyclopedia.com/lupkynis-vs-benlysta-for-lupus-nephritis/
Someone needs to fix this: Skyrocketing growth in PBM formulary exclusions continues to raise concerns about patient access
https://www.xcenda.com/insights/skyrocketing-growth-pbm-formulary-exclusions-concerns-patient-access
https://endpts.com/pile-on-over-pbms-continues-with-ftc-comments-and-a-new-bipartisan-senate-bill/
Thanks Jess- You do a truly excellent job keeping it real and on point!
cheers!
Time is Nephrons
It's a frustrating reality for me to know that a superior drug for LN is not being prescribed currently anywhere near it's potential- the lack of interest in Lupkynis is harming people.
Mary Crimmings, from the Lupus Foundation of America, said this today:
We know it takes an average of six years for a person to receive an accurate diagnosis of lupus. That's why reducing the time to diagnosis is a key priority for the Foundation. Awareness is also the first step to getting people diagnosed and treated sooner.
Aurinia says:
Evidence shows that even a single episode of LN can potentially shorten the life span of the kidneys by decades
https://www.timeisnephrons.com/
It took decades for Lupkynis to get FDA approval. It also easily cost more than the current market cap of Aurinia to get to this point.
It's an insane affront that this is the reality that Lupus Nephritis sufferers experience today.
.....PG is trying to position the price north.
But PG's history of false statements suggest fairly strongly that he deliberately took the price way south first, then scooped up a ton of dirt cheap options for self-enrichment.
I miss Richard Glickman; solid character, consistent, a genuine straight shooter, etc.
PG looks like a sleazy slimeball by contrast.
I say it's no coincidence that a lot of institutions bailed when PG pulled his "read between the lines" BS
Maybe too cynical, but that's how it looks at the moment.
Great drug though!
Aurinia Pharmaceuticals Announces Presentations at the 2022 ERA Congress and the 2022 EULAR Congress
https://www.businesswire.com/news/home/20220516005390/en/
How do you see AUPH in the next few months....
Caveat: Those toy "Magic 8 Balls" would likely substantially outperform my prowess for prognosticating. I recall the adage 'if you're going to predict, predict often'. I never get the memos announcing market tops and bottoms, but I'm fairly confident we're closer to the nadir than the zenith.
But since you asked, here's how I see The Good, The Bad And The Ugly re Aurinia:
It's good that the script numbers are improving, along with retention rates, etc.
It's good that AUPH has an FDA approved product for an underserved market and a decent cash cushion; a sharp contrast to many other bios.
It's bad that the XBI has really tanked badly over the past year, and recently hit a 5 year low.
The uncertainty created by Putin's invasion/war with Ukraine, the overall stock market collapse in many sectors, rising interest rates to fight the highest inflation in 40 years, the continuing COVID outbreaks, the political and economic divide in America, etc. are all contributing to negative market sentiment.
Since more than 120 biotechs are now trading at less than their cash value, I would guess the market would value AUR 200 & 300 at near zero.
I don't really know anything about them as they are such early development stage properties.
While it's good that 90% of lives in the USA are covered for Lupkynis, it's truly disappointing that so many rheumatologists and nephrologists seem to be amazingly ignorant of the vastly superior treatment qualities of Lupkynis and apparently instead prefer to start their patients on the garbage drug Benlysta.
I can't picture how these supposedly professional "doctors" could sleep at night if they knew the harm they are doing by ignoring/bypassing Lupkynis.
We have to hope that soon the Lupus Nephritis treatment guidelines are reviewed and rewritten so that Lupkynis is able to rightfully take it's place as the new SOC.
In short, I'm cautiously optimistic
cheers
Pablo- Hollywood Beach Boardwalk....
That's a nice area- good for you!
Haven't been to that coast in many years, but lived in Pompano (Lighthouse Point) for a few years in the 60's and went to public schools there.
Best of luck to you as well!
Pablo- Just goofing around; couldn't resist.
I know the ARIA story- one of my greatest mistakes. I gave up and dumped a pretty decent position just 2 weeks before the buyout news.
Didn't know about the iHub ARIA board then- I'm guessing if I had I would have been rewarded.
The iHub experience has been a good one for me, and this board especially.
cheers
"We need an Alex Denner Savior here."
Why? Because he's done so well with AMRN?
Also liked this from Lunacy:
@BioLunacyJG
$AUPH
• 70% of pts still on Tx @ 6 months
• PSF conversion rates at 80% by 90 days
• 90% Covered lives in US
• March record month for company
• Strong start to Q2 for PSFs & Rx
• Strong cash position ($419m )
• PG makes my skin crawl
From current issue of Barron's:
Big Pharma Has Enough Cash to Buy All of Biotech. Why M&A Isn’t Happening.
By Josh Nathan-KazisFollow
May 6, 2022 9:40 am ET
Late last year, Barron's predicted a wave of deals, citing biotech companies' cash holdings.
With biotech stocks off nearly 60% from their February 2021 peak, and big pharma firms flush with cash, why haven’t there been more acquisitions this year? It’s a healthcare market paradox.
A note Friday from Jefferies analyst Michael Yee highlights just how far biotech valuations have fallen, and how much cash the big pharma giants have on hand. The largest biopharma firms right now have almost enough cash to more or less buy every single small-to-mid-cap biotech company.
Yee calculates that the combined market capitalization of all the biotech stocks valued at under $5 billion is around $350 billion. The cash balance of the top 20 biopharma companies combined, meanwhile, is over $300 billion.
“We have reached a point where Big Pharma has so much cash they could basically buy the whole smid-cap universe,” Yee wrote. “We note M&A is tough when markets are falling fast …but eventually a few deals could catalyze things back up.”
Late in 2021, Barron’s predicted a wave of biotech M&A this year that would lift the sector. Citing the “tons of dry powder” in the vaults of Pfizer
Pfizer Inc., Novartis (NVS), and others, we argued that a wave of M&A would “reawaken investor interest in biotech.”
This is an interesting post re payers covering Lupkynis:
(20 hours old)
Sue
@Sue_S_E_N
CVS, the largest Commercial payer, now shows up on the Coverage app for covering Lupkynis in many states. I think the dot goes from red to yellow if the majority of companies are covered? CVS had an ICER 100K max limit, and they dismissed that limit for $AUPH's Lupkynis!
nferna- thanks for posting Lunacy's comments re yesterday's ER webcast
Gotta love Luna saying My discontinuation, tolerance, & adherence concerns alleviated
Wow! Thanks Jess! Lupy on the list of potential blockbusters…
I missed that when it appeared earlier
Now if someone will just take away Putin's red button.
Maybe substitute a fake or a toy?
He and Trading Cyclist were big reason I got into Auph after P2 results in 2017.
Me too. Also vidpok
cheers
Newbie1421- Re Lunacy: From another board:
@BioLunacyJG
Feb 28
AUPH I exited a large % of my position today. Held almost everything from $2/$3s, so still a nice return. My biggest immediate issue is trust in leadership. There are also new concerns around tolerability, adherence, etc. that I need to keep a close eye on moving forward.
Let's save some time- just post that info for Kaiser
TIA
So are you saying that Kaiser sets the prices for FDA approved drugs?
Seems totally bizarre!
I'm curious what price Kaiser has set for Lupkynis?
And also how they arrived at it.
And also who sets the prices for Kaiser's health plans?
TIA
Also worth considering: annual dialysis costs in the USA now average $90,000 per patient.
Medicare is currently spending $28 Billion annually for kidney dialysis treatments.
Compared to the high cost and high inconvenience of dialysis, Aurinia's Lupkynis is a clearly superior alternative.
If only someone knew how to sell it!
zzaatt is correct- there is zero evidence that Lupkynis is overpriced:
https://financialpost.com/pmn/press-releases-pmn/business-wire-news-releases-pmn/aurinia-announces-positive-cost-effectiveness-assessment-of-lupkynis-voclosporin-in-latest-icer-draft-evidence-report
Here's what ICER says:
Key Cost-Effectiveness Findings
ICER’s recommended health-benefit price benchmark (HBPB) range for belimumab is between $45,000-$61,000 per year, while ICER estimates that belimumab’s actual annual net US price is approximately $43,000 for patients remaining on treatment. ICER’s HBPB for voclosporin is between $72,000-$101,000 per year, while ICER estimates that voclosporin’s actual annual net US price is $92,000 for patients remaining on treatment.
The HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.
https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-therapies-for-lupus-nephritis/
Not overpriced, but definitely underutilized!
The natives are restless everywhere- interesting post from ST:
NOiAmSpartacus
Bullish
AUPH
”Hi…I’m Peter. With the fed looking to aggressively increase rates, BP patent cliffs upcoming, & along with more BP failures & opportunities dwindling with others too by the FDA… that interest free $500 million cash in the bank as we prepare to go profitable looks PRETTY DAMN GOOD right about now!!! Oh! But I’m sure there are some Einsteins here on ST that know better? I know I don’t coddle & talk enough to u guys about what my thoughts are & what every subliminal intent is with my every word ?? but I got other fish to fry… like running a billion $ company & setting us up for success! Just keep whining & armchair quarterbacking. Did any executives or Board members including myself me unload shares in the low $30’s? Hell NO! Too Cheap.
Anyway… good talk! “
Obviously not everyone is aware of the current, widespread depression/crash happening in biotech.
Hard to believe since it's so massive and prolonged.
Maybe some have heard that the biotech market is currently "on fire" but do not comprehend that description is in reference to a dumpster fire.
A viable treatment for Myopia would probably be worth trillions of $$$.
Clearly some are experiencing incredibly painful suffering.
I interpret their desire to share their agony as a cry for help.
But they won't accept the real help that is offered.
All in world gone mad!
Hallelujah anyway!
Cosa- Kudos on your perfect timing! Amazing!
Was it pure luck or a premonition or ???
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168481048
cheers
There's a man with a gun over there....
The world has to be hoping that man puts a bullet into Putin's brain ASAP.
Self-inflicted would be even better.
What a worthless, murdering, inhuman, totally evil, scumbag/dirtbag.
For What it's worth
Buffalo Springfield was awesome!
'A misstep by the company in the actual filing process ...'
I thought the FDA found RVNC deficient in 5 areas of quality control in their manufacturing process.
Won't they have to raise $$$ before crossing the finish line?
TIA
'...for us it is meaningless seeing how time has passed with no further discussion in a BO of auph...'
How do you know the BMY discussions are over?
I'm not so sure