Aurinia Pharmaceuticals Inc (AUPH) ニュース

Thx. but near term I'm more interested in ARDX and UNCY .
Both will benefit if the Kidney Patient Act pass's this yr .
New push in Congress
https://higherlogicdownload.s3.amazonaws.com/NRAA/8eb5e347-a0f4-4216-aac1-f22e0d697983/UploadedImages/Content/2024/RHA_Advocates_to_Protect_Access_to_Phosphate-Lowering_Therapies_11_21_24.pdf

High risk ...not investment advice etc
Kiwi

it has to be expensive
have to cover petties 10 million a year for being incompetent somehow.
go ahead and gamble here throw 1700.00 dollars at it like jes has.

Well Jess I look forward to you reminding me to buy AUPH at $6 ...if it hits $12 .
I wouldn't be surprised if Tang made an offer to take over the Co at around $10 -$12. The new ACR guidelines should definitely help drive script numbers but remember without insurance Lupkynis is around $93,000 a yr while Benlysta is around $43,000 a year .
Lupy is a very expensive drug
So insurers want Nephrologists to try Benlysta first and only cover Lupy if they fail on Benny .

I'm more interested in VERA who appear to have the best drug for IgAN
Completed enrollment of the primary endpoint cohort in the pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN; topline data expected in Q2 2025
So Q2 in 2025 top line data .
ARDX ... interesting situation with their drug Xphozah for lowering serum phosphorous in dialysis patients .
Medicare to drop coverage starting Jan 25 since they haven't applied for the TDAPA process which would now put them into the dialysis bundle and eventually limit their script numbers because of the way the bundle works .
So these patients are about to lose coverage for the only drug that works for some getting their pho levels to goal ...where all the existing meds don't.
Kidney Patient Act in Congress with 42 co sponsors now, to try and maintain coverage but running out of time .
Compromise with CMS is possible
UNCY ..one of the best new drugs for serum pho ...PDUFA data mid 2025 and if approved likely to be a big beneficiary if the Kidney Patient Act pass's ...or some comprise is worked out with CMS .

Lets see how this post has aged if AUPH hits $12

Good luck
Kiwi

Well, just remember that I reminded you when it was even at 6 about maybe a couple of months ago.

Thx Jess but I think Lupy is still seen as " when all else fails ...try Lupkynis "
This is primarily because of its pricing and the road blocks insurers put up to try and avoid paying for it .

Benny is significantly cheaper , is a sub Q , does not allow as fast a steroid taper as Lupy ...but because its some much cheaper insurers often want patients to try that first
The drug ( Lupkynis ) faces competition from GSK’s Benlysta (belimumab), which received FDA approval slightly earlier in December 2020 and EMA approval in May 2021. Despite Benlysta being a subcutaneous treatment, it is projected to outpace Lupkynis in sales by 2030. According to GlobalData’s Pharma Intelligence Center, Lupkynis is expected to reach $447m in sales by 2030 while Benlysta is forecasted to generate $1.76bn.


AUPH has slashed payroll so major cost saving there and Tang is probably trying to get the Co ready for a sale
Good luck
Kiwi

Kiwi, time for you to take Auph seriously. You have a chance to double your money here now. You know it’s coming soon. You can try 1700 shares like Cervelo.

Not massive volume today but 2x average so not bad.  Hopefully this continues.  

Anything will help at this point RMB. My reply to your recent post about pricing flexibility is that it should have been a priority for management the minute management decided to go-it-alone.

Prescribing Lupkynis allows Nephrologists to taper steroid use faster . This is a good thing . Patients are more prone to infections , weight gain and mood swings on steroids and the patients usually hate them
Kiwi

Anyone have any thoughts on the new revised American College of Rheumatology guidelines for treatment of LN? Aurinia seems to think they are an improvement:

https://www.businesswire.com/news/home/20241118903839/en/Aurinia-Commends-2024-Updated-ACR-Guidelines-for-Screening-Treatment-and-Management-of-Lupus-Nephritis#:~:text=The%20guidelines%20call%20for%20a,acceptable%20maintenance%20dose%20of%20steroids.

Otsuka launching Lupkynis today in Japan:

https://www.otsuka.co.jp/en/company/newsreleases/2024/20241120_1.html

Hey! We were enjoying the peace and quiet here....

Wow the excitement on this board is overwhelming.

Fair enough Kiwi.

Well Jess you can review all my posts on Ihub ....boards posted on etc ...and review my positions on APP, RZLT , SWAV , SLNO etc .
APP and RZLT I still hold .
SWAV was bt out and selling SLNO ( up about 7X at time of sale ) was a huge mistake ( as I've noted )

Re AUPH , KZR , UNCY and ARDX
I'm not negative on AUPH . I think I responded to a post from Cosa some time that if I owned it I probably wouldn't be selling it .
However I'm not super positive on it and think theres limited upside .
Re KZR vs AUPH ...the early data on KZR IMHO looked better . But Co ran into mgt / BOD issues and eventually adverse events torpedoed the stock .
I posted long ago why I was exiting KZR

UNCY and ARDX
CMS appears determined to sink any opportunity for dialysis patients to be prescribed these new serum pho lowering drugs .
Yes they may have access to them , but the way the dialysis bundle works ( providers get to keep any $ left over between what CMS pays per dialysis ...about $273 .. and what they spend ) essentially means that dialysis providers won't prescribe the new Brand pho lowering drugs because of the expense of these new drugs .... and will push the low cost generics instead .
This will change if the Kidney Patient Act pass's

I expected UNCY to rally on FDA approval of its NDA ...Instead the mkt sold the news .
So I was very wrong on that

Kiwi

You said also then that KZR’s LN product in trial was going to be better than Lupkynis. That trial is now dead and buried. You are also so high in UNCY and ADRX. They seem to be fading now.

Not that I'm aware. Do know we have ability in ghat regard since we have huge margins.  Maybe the focus is so much on selling the company that they don't want to fiddle with that. 

We haven't heard one word about pricing flexibility, have we?

Yes it has looked like Powell is developing a spine (although he did cave during Trump's first term and may yet again) but saw story this morning Musk and others pushing to have Fed under control of Pres:

https://nypost.com/2024/11/11/business/elon-musk-backs-call-to-place-fed-under-trumps-control/


Hopefully with workforce reduction and Tang onboard we can get Auphie moving and sold before Vera enters the scene. 

Powell till mid 2026 which IMHO is a good thing
Re Tang Capital https://www.insightia.com/tang-exits-la-jolla-in-buyout/
Trumps win might make it easier to get a deal done ...M&A likely to increase
Re AUPH's P1 in Baff / April ....VERA is way ahead and IMHO will dominate this field

Kiwi

Stocktwits is a fire over this post:

https://x.com/tonkhalife/status/1855663911237747004?s=46&t=VJb6Ff31iAXg1p7xDcqPUQ

A Fierce Pharma article dated today about the restructuring, (As a side note, I didn't know that sales were flat from 2Q to 3Q so I will have to go back and look at that again):

https://www.amazon.com/YOGINGO-Pack-Christmas-Stockings-Personalized/dp/B0D86JV9ZQ/ref=sr_1_41?crid=1M8FRWGP1DKNR&dib=eyJ2IjoiMSJ9.P8XAFzm46Eai6mU0rxi3J657M6xzme7YFrtWeGO8Ahf5iEyxaa59x5UEfo2Pv8ou-RabXdTMjVcejZZbdETKHNdygdyXHKxl3FfdVnbe37_D9DIhEzbXxH_Y_3X2D3yhJ8hB3G35XqSNC8s-KwqGY0-YtcJAX61IcWZ3f5CCGjV6NMH9Q2hRVb2_YkHUwdBtFjDswLBWzLX37K9qkZGoRXr1XFshtSY2Jebev6a2fHYA77wocgoYlpiDeLzCMls71OzOwlD96yOHCo95Z26K0puFLkBiC_h6ptHEKLvSwUQ.AF18_HCbKa0FQd125MB3rir03ZFnegC_Hx0_-2CkKvI&dib_tag=se&keywords=christmas%2Bstockings&qid=1731015416&sprefix=christmas%2Bstocking%2Caps%2C191&sr=8-41&th=1

"After an activist investor revolted against the leadership team at Aurinia Pharmaceuticals, the CEO in question is resorting to restructuring.

Aurinia on Thursday unveiled a strategic overhaul that will slash 45% of the Canadian biotech’s entire workforce.

Aurinia expects the trimming will save it more than $40 million in annual operating expenses. The move will allow the company to focus on the commercialization of its lupus nephritis drug Lupkynis and the development of AUR200, an autoimmune disease candidate that Aurinia recently salvaged from its garbage can.

The cost savings will strengthen Aurinia’s financial position and “provide more flexibility to engage in future business building activities,” CEO Peter Greenleaf said on an investor call Thursday.

This marks the second round of layoffs at Aurinia in less than a year. Back in February, following a fruitless search for a potential buyer, Aurinia decided to reduce its headcount by about 25%.

At that time, Aurinia had decided to discontinue AUR200 but later revived the APRIL/BAFF inhibitor. Now, CEO Greenleaf in a Thursday statement said the organizational overhaul will help Aurinia accelerate the development of AUR200, an “important pipeline product.”

Greenleaf’s leadership at Aurinia was put into serious question when he and three other Aurinia board directors lost majority stockholder support during the company’s annual meeting. The company’s proposed executive pay packages also failed to garner majority investor backing.

As required by Aurinia’s company policy, the four directors submitted their resignations. But the board, while accepting the resignations of the other three members, argued that “there are exceptional circumstances that warrant the rejection of Mr. Greenleaf’s conditional resignation,” it said in a September securities filing. As a result, Greenleaf stayed on.

RELATED

Investor activism resurfaces at Aurinia after CEO’s board role, exec pay lost majority support
Amid broader investor disapproval of Aurinia’s leadership team, an activist shareholder who owned 2.2% of the company’s stock in August called for board and management changes, blasting them for “unchecked spending, ineffective leadership, and a clear lack of strategic direction.”

Lupkynis is currently Aurinia’s single commercial product, with third-quarter sales of $55.5 million. The number represents 36% year-over-year growth but is flat compared with $55 million in the second quarter. The number of patients on the therapy has grown about 25% to 2,422 as of the end of September, Greenleaf told investors on a call Thursday.

“This significant year-over-year growth was driven by patients restarting Lupkynis after being off therapy for an extended period of time, as well as hospital fills and maintaining high persistency rates year over year,” he said.

With total product revenue of $158.6 million in the first nine months of this year, Aurinia has kept its full-year guidance range of $210 million to $220 million.

As to AUR200, the company in September dosed the first participant in a phase 1 single-ascending dose study, with data expected in the first half of 2025. Aurinia has not disclosed the indications that it plans to develop AUR200 in. "

Some similarities and some not when comparison to LaJolla.  One thing that is similar is they had a drug that in no way met sales expectations as is the case here.  But I assume that you don't mean that being "Tang'd" is necessarily bad unless someone has a high cost basis here.  

Not sure if you saw today that Powell of the Fed Reserve developed a backbone and is saying he won't step down if asked. 

did you ring BR?

I think the move is the new guy on the BOD ...believe he is a Tang guy from La Jolla days ( which was acquired )
You're about to be " Tang'd "

Kiwi

Announced a strategic restructuring to "focus on Lupkynis and AUR200".  What the hell were they focusing on before?

To me it sounds like they are clearing the decks to be acquired. 

Well touching $8 in premarket this morning.  Announced earnings.  $.10 per share profit.  Laying off 45% of employees.  Probably none of the fat cats. 

So, this thing looks like it wants to move higher. Question is, will it stop at 9.5 or will we see double digits?

Wow. Same old story from you. Let Jess cheer you up!

and because of pete
AUPH (acquired by no one).

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Any time there is a big last minute move on an options expiry day it is likely to be options related in some fashion.

That said, they never got it down to 7 and there wasn't that much open interest in the 7 calls, especially if you think that most of today's volume in the Oct 7 calls was closing transactions (which I believe to be the case).

From X 3,500+ contracts sold today at the $7 strike with a high of $0.24 per contract.
MM’s raked in at least $40k today by bringing it down to $7 like that with no incoming bids.

Kidney wk next wk. 23rd-25th AUPH presenting some RWE ( real world evidence ) UNCY has several posters and VERA will publish their long term data on IgAN ...suggest U watch this release . Does Atacicept preserve kidney function ( eGFR ) over 96 wks better then the existing IgAN meds that simply slow decline

Kiwi

Was today’s late day drop option exp related? Seems it was steady almost the entire day and then wham.

That must have been pretty well discounted as our stock here not doing much on the news.

Our rival has news:

Oct 17 (Reuters) - Kezar Life Sciences (KZR.O), opens new tab said on Thursday it would terminate its mid-stage trial studying its experimental drug in patients with active lupus nephritis and focus on
developing the drug for a rare chronic disorder called autoimmune hepatitis.

That's the way I figured it. Of course, I have bought deep in the money, far out AUPH calls before thinking "of course it will be sold by then", so nothing is a sure thing.

Probably a good purchase. If no sale of company you still would lose very little if any.

Lord help me - I bought some AUPH calls!

I paid $2.48 for April 5 calls - pretty deep in the money. I am pretty confident AUPH will be sold by April. While we probably won't see a price in the $30 range like many old-timers had been hoping for, I do think we will get $10-$12. That would be a nice return.

Having been in AUPH so long, and with such high hopes, it is hard to re-track my thinking to look at AUPH as it stands right now.

Yep, home safe and sound. Funny about Tang and Kezar. They stopped the trial for LN and now FdA issuing a clinical hold. Would love to know Tang’s thinking on this.

Well hope U got out in time . Tang offers more than $1 a share for KZR ....will probably offer $10-$15 a share for AUPH .
Looks like he's trying for control of the severe LN market ...especially since VERA etc aren't pursing it
JMO
OMG. ...I just might have to buy some AUPH
Kiwi

For you Tang fans out there
$KZR Tang with a non-binding proposal to acquire 100% of the equity of Kezar Life Sciences, Inc. for $1.10 per share in cash, plus a CVR

https://archive.fast-edgar.com/20241008/ABBOQ22CIC22L2ZZ282R2MZZL8LQZ2Z2Z262/

Kiwi

No, opposite side of the state - 7 miles south of Daytona. Track of storm right now runs right through Orlando. Hoping it stays slow moving and our booked flight can get out Tues afternoon.

RMB. The Nephrologists my wife works with state their biggest problem is insurer push back due to cost of Lupkynis . Currently insurers in our area only want to cover for severe cases of LN where the patient has fairly rapid loss of kidney function ...ie for last best attempt ...and usually only for 6 mths .
Were you from the Tampa Bay Area ?.....looks to be pretty dicey next week
Good luck
Kiwi

Thanks for the article. I had previously seen it a while back and it is a good explanation of both drugs. However I guess it still comes down to what the person’s insurance co wants to do.

Yep, docked in Ft Lauderdale yesterday morning, rented a car and drove a couple of hundred miles north to spend the next few days seeing friends, etc where we spent 45 years of lives. Due to fly out of Orlando Tuesday afternoon, but now worried the approaching hurricane may throw a monkey wrench in that.

RMB. U might find this interesting
https://www.lupusencyclopedia.com/lupkynis-vs-benlysta-for-lupus-nephritis/

U back in the US or still aboard that floating Petri dish :--)

Kiwi

Do you think a potential acquirer will have that as a concern as well though. I suppose it would all depend on the price they would have to pay.

RMB Because of the expense of Lupkynis ...around $90k a yr ..insurers have major prior authorization hurdles often requiring Benlysta to be tried first . Benny is around $50k a yr and due to go generic in 2025
The patent for Benlysta is set to expire in the United States in 2025 and in Europe in 2026

Tangs a major AUPH player now and will definitely want a deal done before a generic Benny is available.

On September 6, 2024, TANG CAPITAL MANAGEMENT LLC (Trades, Portfolio) made a notable addition to its investment portfolio by acquiring 4,450,000 shares of Aurinia Pharmaceuticals Inc (NASDAQ:AUPH), a biopharmaceutical company based in Canada.Sep 12, 2024
JMO
Kiwi

Could that be the reason for reticence by potential buyers?

Don't they need a sale soon, hopefully before the end of the year?

Lupkynis is a drug owned by Aurinia Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2021 to 2023 out of which none have expired yet. Lupkynis's patents will be open to challenges from 22 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2037. Details of Lupkynis's patents and their expiration are given in the table below.

Patent # US7332472 Cyclosporine analogue mixtures and their use as immunomodulating agents
Expires: Oct, 2024 (11 days from now)
Status: Active

Patent # US11622991 Protocol for treatment of lupus nephritis
Expires: Dec, 2037 (13 years from now)
Status: Active

Patent # US10286036 Protocol for treatment of lupus nephritis
Expires: Dec, 2037 (13 years from now)
Status: Active

https://pharsight.greyb.com/drug/lupkynis-patent-expiration