Ardelyx Inc (ARDX) Quote

Why did this turn around today?  Passage of kidney bill increasing chance?

Well I guess there is no 3rd time this year. Market cap dropped to $1.07B. Uncertainty with CMS really weighing this down.

Don't know if there is another bill that has any many signers/co-sponsors/whatever they call it, so hopefully it happens.  

RMB re Wainwrights downgrade etc . The current position of CMS means that although patients may have access to the new serum pho lowering drugs ...the dialysis providers are unlikely to prescribe them .
The reason is the way the dialysis bundle works .
CMS has agreed to pay around $273 per dialysis and the way the contract with providers work ...providers get to keep whatever $ are left over between what CMS pays and what it costs them ...per dialysis

So the dialysis providers will make more $ if they continue prescribing the existing generic serum pho drugs .
Theres no $ incentive ( or $ neutral way ) to prescribe the new serum pho lowering drugs even tho they may be better for the patients .

The only hope of changing this it appears ...is the Kidney Patient Act working its way thru Congress

Kiwi

That and possibly HC Wrainright downgrade. HC W is the most optimistic analytical firm to boot

Tanking again this morning possibly because UNCY's drug got accepted for review by FDA

https://kidneycarepartners.org/press/kidney-care-partners-supports-policies-to-expand-home-dialysis-and-improve-reimbursement-for-phosphate-lowering-drugs-remains-concerned-cms-has-not-addressed-barriers-to-patient-access-to-innovative/

Kiwi

Also beginning Jan. 1, 2025, the bundled payment will include oral-only renal dialysis drugs and biologics — a move initially set to begin in 2014 but delayed until now by several laws and court challenges.

“In response to comments that we received on the proposed rule [released in July], we are finalizing a policy to pay the [transitional drug add-on payment adjustment] for phosphate binders based on 100% of the average sales price, increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a [transitional drug add-on payment adjustment] payment for phosphate binders. We expect that incorporating oral-only drugs and biological products into the [End-stage Renal Disease Prospective Payment System] will increase access to these drugs,” CMS stated in the release.

In a response statement, Kidney Care Partners (KPC), a non-profit coalition of stakeholder organizations, expressed concern that “the base rate is insufficient to support adding new treatment options without adding new money.”

“We applaud CMS’s efforts both in recognizing that providing oral-only medications as part of the bundle requires additional funding, as well as creating access for AKI patients to home dialysis,” Mahesh Krishnan, MD, MPH, MBA, chair of Kidney Care Partners, said in the statement. “However, KCP has consistently raised concerns that significant changes are needed to the ESRD PPS system to maintain an appropriate level of care, access and reimbursement for the more than 557,000 Americans who rely on regular dialysis treatment.”

KPC urged support of the Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S. 4469) to provide a permanent reimbursement pathway for innovative drugs and devices.

Kiwi

That's why I pay attention to your posts.

I'm just lurking in the background until it really corrects, if it ever does.

Going against CMS was unlikely to end in success, sadly. This still sucks cause wtf. Corrupt country to the bone.

Ernie. Not a complete surprise . I posted this opinion some time ago

Monday, October 07, 2024 11:17:05 AM
Post# of 1648
Likely reason for sell off ...CMS likely to prevail


Richard Cantillon
@cantilloncap
·
36m
My best guess is CMS wins and Court declines motion for prelim. injunction & sets a new schedule for MSJs. A better bet is HR5074 but I think we need 50 co-sponsors to really feel comfortable here. $ARDX

Always thought the Kidney Patient Act has a better chance ( but obviously no guarantee )

Kiwi

Ardelyx (NASDAQ:ARDX) plunged 17% after a court dismissed a lawsuit the company filed against the Centers for Medicare and Medicaid Services (CMS) over its proposal to bundle its kidney disease therapy Xphozah in the Medicare payment system applicable for dialysis services.

"Defendants’ motion to dismiss is therefore granted, and plaintiffs’ motion for a preliminary injunction or expedited summary judgment is denied as moot," US District Judge Beryl Howell wrote in an opinion.

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In October, the FDA approved Xphozah as a late-line add-on therapy to cut serum phosphorus in adults with chronic kidney disease on dialysis.

The issue relates to Medicare’s plan to include Xphozah, along with all other oral-only phosphate-lowering therapies (PLTs), in its End-Stage Renal Disease Prospective Payment System (ESRD PPS), a bundled payment system for dialysis services.
Ardelyx (ARDX) didn't immediately respond to Seeking Alpha email request for comment.

The decision, which will take effect on January 1, 2025, can potentially eliminate Part D coverage for Xphozah.

The plaintiffs alleged that the Medicare proposal violates U.S. law, noting that dialysis providers do not administer Xphozah and other PLTs, currently offered under outpatient pharmacy benefit plans such as Medicare Part D.

What we think about ARDX on 11/01/2024 MarketEdge
Stock is a Short Sale Candidate.
If you are Long; close position or monitor stock closely.

how much do you reckon uncy will charge?

how much do you reckon uncy will charge?

Almost 5 million shares traded in first half hour.  

Bug drop and seeing posters elsewhere saying court case has been dismissed. Only hope now is Kidney Act.  Disaster du Jour. 

Mr Mister To the best of my knowledge , generic Renvela is the serum pho drug most prescribed to dialysis patient .
It cost about $1 per capsule and most patients need 2-3 with each meal ...so $6- $9 a day ...... max of $270 a month
Most patients don't like Renvela ( it does work at the prescribed dose ) because it's usually 2- 3 large pills with every meal ....and most patients can't stick to that so serum pho levels are usually higher than they should be .

UNCY's OLC if ever approved , is one small pill with each meal and for Medicare patients should only cost roughly $ 60 more per month

ARDX's Xphazoh ...2 small pills per day .... will be at least $300- $400 more per month for Medicare patients as currently priced . ( about $200 more per mth if priced as per Ibrsela )

JMO ...based on the info I have access to

Kiwi

Until or unless binders start working for people, Xphozah has no commerical or competitive reason to reduce their prices. That may change if or when UNCY finally gets its OLC approval but that isn't expected until the middle of next year.

There's also no guarantee UNCY won't charge a premium for its product.

But time will tell and may eventually prove you right

MrMister. It's a dumb pricing move IMHO .
If the FDA accepts UNCY's NDA ( the decision appears imminent ) and UNCY's OLC eventually gets approved .....Nephrologits and their patients will have a choice
Xphozah at around $3,000 a month or OLC at around $1,300 a month ...the Medicare patient copay is usually around 20-30% of these costs
OLC will be substantially cheaper ...AND is actual more effective at lowering serum pho ( although requires 3 small pills a day vs 2 for X and has different side effects )

Kiwi

So crazy.  How can a stock be up over 13% one day and down 5% in premarket the next on no news!

You're allowed to object. You're not allowed to tell them what to charge, especially after the long regulatory approval road the FDA put them on. Had the FDA given them a broader label, maybe they would have priced it more similarly to the binders it competes against or supplements.

As it stands, Xphozah is priced to the allow the company to recoup its time and investments. I applaud Ardelyx for not allowing CMS to destroy its prospects

MrMister I object to the premium ARDX is charging for Xphozah compared to what they charge per gm for Ibresla ...its the same drug Tenapanor .
Most on dialysis are on Medicare and have limited income . They are in a dialysis chair 4 hrs a day for 3 days a week . Since they are on Medicare they can't use any coupons .
At most Medicare will pay about $2,400 of the monthly cost with the patient paying the remaining roughly $700

How many of my wife's Medicare dialysis patients can afford the roughly $700 a month copay for Xphozah ......Zero .

So yeah ...I object to their pricing

Kiwi

Agreed. The real problem CMS has is that Ardx makes enough money to wait them out. Amazes me that some of the posters here complain about the price of Xphozah. Ardelyx priced it as such for a reason and now has the means to fight the ESRD bundle

Trump victory and a a new co sponsor to the Kidney Act bill look positive for ARDX .
Kiwi

Thx. So they have increased the payment per dialysis to $273 and state the following
In response to comments that we received on the proposed rule, we are finalizing a policy to pay the TDAPA for phosphate binders based on 100% of the Average Sales Price (ASP), increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a TDAPA payment for phosphate binders.

I believe the dialysis centers can keep any money saved below the $273 paid per dialysis ...so the incentive is to push the existing generics not new brand Oral drugs even if the new drugs are more effective for some

The CMS payment system for dialysis services uses a bundled prospective payment system (PPS). Under this system, facilities receive a set payment amount per treatment, regardless of their actual costs3.
If a facility's actual costs are below the bundled payment amount, they likely can retain those savings. The PPS is designed to incentivize efficiency in providing care.

Kiwi

Final rule from CMS regarding ESRD payments:

https://www.cms.gov/newsroom/fact-sheets/calendar-year-2025-end-stage-renal-disease-esrd-prospective-payment-system-pps-final-rule-cms-1805-f

Re UNCY we should get an announcement before the open on Mon. Latest would be Thursday as per material info disclosure regs . They are using the 505(b) 2 pathway ( stripped down version of usually FDA multiple trial pathway as OLC is only a reformulation of an existing drug ...Fosrenol ) .
They increased the numbers in their final trial with dialysis patients , Octagon made a large investment recently ( I assume they did a ton of DD ) ...so it will be a real surprise ( and trash the stock ) if their application is rejected.

Re ARDX IMHO Co over priced Xphazoh vs what they charge for Ibresla ( it's the same drug Tenapour ) . Based on Ibresla pricing X should cost around $2,000 ....not $3,000 a mth . Medicare patients can't use coupons so would need to pay around 25% of the cost . Risk is that MD's start prescribing X less if they expect it not to be available Jan 1st .
Congress is back in session for at least a few weeks after this election ....so hopefully we'll get some action / more co sponsors for the Kidney Patient act .
I doubt dialysis units are set up properly to store, record and distribute X so it's a mess for all concerned ....unless CMS and ARDX come to some agreement / settlement or the govt acts
JMO

Kiwi

Thanks Kiwi. If by Friday you mean yesterday, then we didn’t get a negative PR. Hoping for something +ve early this coming week.

ARDX mgt has argued that including X in the dialysis bundle will limit access to the drug for high serum pho patients . This is likely to be true eventually since the way the dialysis bundle works , expensive brand drugs will be prescribed less than cheaper generics.
It won't make any difference in the first 2 yrs if they had signed on to the TDAPA process.
Meanwhile ARDX wants Nephrologists to keep prescribing X even tho those on Medicare won't be covered if CMS proceeds in Jan 2025 . ARDX argues that if their Medicare coverage is dropped these patients may still be covered by ARDX Assist

The Kidney Patient Act looks to me to be an easier win if they can get 50 bipartisan co sponsors ( currently at 38 )

Meanwhile nail biting time with UNCY . Deadline for FDA decision is Sun Nov 3 .....plus 4 days for disclosure regs ( if necessary ) . Fear is always an after hrs -ve news release on a Friday
Kiwi

What gives you so much confidence of a win against CMS?

2 approved drugs with stellar revenue growth qtr over qtr. Victory against CMS coming soon. And then M&A activity starts. Easily a 3x from here but most likely 5-8x on the upper side.

https://www.congress.gov/bill/118th-congress/house-bill/5074

Currently we have 38 co sponsor . Current opinion is that we need 50 bipartisan co sponsors to be confident of victory ...by EOY

ARDX ( Xphazoh ) will lose coverage for those on Medicare starting Jan 1 if CMS prevails since mgt did not apply for TDAPA in the new CMS program
Kiwi

RMB. It all comes down to getting a court injunction to prevent CMS from pushing new oral binders into the dialysis bundle OR passage of the Kidney Patient Act ...now 38 co sponsors ( ideally U want 50 and bipartisan ) ...BEFORE EOY .
Demand for Ibsrela and Xphozah is strong ...particularly Xphozah ...however the patient mix for X is 40 % non Medicare and 60% Medicare . They lose the 60% Medicare if CMS prevails as they didn't start the TDAPA process which would have generated $ in the first 2 yrs but cost them scripts after that ( because of the way the dialysis bundle works )
So theres significant upside IF they prevail against CMS and IMHO the Kidney Patient Act has a better chance than their legal effort.

Meanwhile ...UNCY ...FDA to notify Co by by Nov 3 if their NDA is accepted . UNCY's OLC is also a new oral pho binder and will benefit from any legal or legislative win ARDX achieves . UNCY's OLC is actually a stronger at reducing serum pho , 1/3 rd the cost of X and doesnt cause as much diarrhea .

Kiwi

Don't worry about the share price, it's rigged. Eventually they wont be able to hold it down.

Well not anymore. All afterhour gains evaporated.

Market seems to like earnings released today. Good increases in sales of the 2 drugs. Revenue increase but earnings decrease. Increased SGA costs. Bugs the heck out of me when they don’t control spending better but as long as sp advances.

I hope so. On a Yahoo Finance app I have it says avg price target is $11.65

The two biggest bull runs of this ticker started in November of 2022 and 2023. 3rd times a charm?

From Rose on X

Rose Han
@itsrosehan1
$ARDX

Ardelyx gains bipartisan support for potential kidney disease legislation

Ardelyx, a biopharmaceutical company focused on developing innovative treatments for kidney and cardiorenal diseases, may see increased interest following recent legislative developments. A bill related to kidney patient care, H.R.5074 - the Kidney PATIENT Act of 2023, has gained additional bipartisan cosponsors in Congress.

The bill, initially introduced by Rep. Carter, Earl L. Buddy [R-GA-1] on July 28, 2023, has now attracted 4 new cosponsors, bringing the total to 37. The new cosponsors, all added on October 18, 2024, include:

1. Rep. Meeks, Gregory W. [D-NY-5]
2. Rep. Velázquez, Nydia M. [D-NY-7]
3. Rep. Gonzalez, Vicente [D-TX-34]
4. Rep. Horsford, Steven [D-NV-4]

This growing bipartisan support for kidney patient-focused legislation could potentially benefit companies like Ardelyx that are developing treatments for kidney-related conditions. While the bill's specifics and its potential impact on Ardelyx's business are not detailed here, increased congressional attention to kidney health issues could create a more favorable regulatory and market environment for Ardelyx's pipeline products.

Investors in Ardelyx may want to monitor the progress of this legislation, as it could have implications for the company's future prospects in the kidney disease treatment space.

Current view is that we need 50 cosponsors or more ...bipartisan ...for this to pass
Kiwi

That would be disastrous for the entire bio industry. Clinical studies from lab to commercial takes at least $500M, that's bare minimal. If the government steps in and reduces a company's potential earnings from a drug, then this will hinder future developments for all bio. This is also the point of patents. To insure the company of the discovery has sole rights to the revenue. So in my opinion, No it will not be in favor. And these big pharma's definitely will have a hand in that No.

The court will move in CMS' favor, no? Surely they have the resources to pay off the right people.

Well hopefully an overreaction. Sitting in SLC waiting for last leg to PDX.

He's just a guy on X looking at the briefs filed in court vs CMS .
Hope U make it out of Florida in time ...looking dicey per the news I see .
Good luck
Kiwi

Who is Richard C? This is the only guy I can find:

https://www.hetwebsite.net/het/profiles/cantillon.htm

Likely reason for sell off ...CMS likely to prevail


Richard Cantillon
@cantilloncap
·
36m
My best guess is CMS wins and Court declines motion for prelim. injunction & sets a new schedule for MSJs. A better bet is HR5074 but I think we need 50 co-sponsors to really feel comfortable here. $ARDX

Why access to these new serum phosphorous lowering drugs is so important
Patients receiving maintenance dialysis for chronic kidney failure have a high mortality rate, with 5-year survival of less than 50% after dialysis initiation in the US.3

Cardiovascular complications are the leading cause of death, with 40% of deaths attributed to arrhythmia or cardiac arrest.3
Systemic complications of chronic kidney failure include anemia, hypertension, and mineral bone disorders, such as hyperphosphatemia and hyperparathyroidism.

Dialysis treatment–related complications, such as vascular access dysfunction, infections, and hemodynamic instability during dialysis, are common and may cause distressing symptoms, including cramping, post-dialysis fatigue, and poor quality of life.4


Kiwi

From Frank on X
Multiple catalysts on the very near term horizon.

CMS / HHS litigation - hopefully headed to PI late
October as per Jeffries analyst Dennis Ding's call last
week
HR5074 - Adding sponsorship daily -today added
Maxine Waters . Hopefully just a matter of time https://congress.gov/bill/118th-congress/house-bill/5074/cosponsors
3Q Earnings- recent RECORD Rx counts as per IQVIA
s/ lead to another GREAT earnings release
Fosun Pharma - Chinese approval expected by end of
the year
ROW partnership- timing TBD

Maxine Waters just became a sponsor of the Kidney Patient Act . Black Americans are a high % of the dialysis population ( compared to their over all % of US population ) and would be disproportionally affected by reduced access to Oral pho drugs ....if the current CMS plan goes into effect Jan 1st
This bill to keep oral pho binders out of the dialysis bundle is supported by members of both parties

Kiwi

I can’t give you the skinny on an ARDX but I certainly am not concerned about the class action lawsuits. Those are just the ambulance chasers that get after every single stock.

I took a fairly small position here today. Thanks