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Thx Ernie
Kiwi

Ardelyx Lost The Lawsuit, But The Kidney PATIENT Act Will Save It
Nov. 24, 2024 6:36 AM ETArdelyx, Inc. (ARDX) Stock14 Comments
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Summary
Ardelyx lost a lawsuit against Medicare, impacting XPHOZAH's revenue potential, with no other major prospects in its pipeline.
CMS's decision to move XPHOZAH to the bundled payment system significantly reduces its revenue, forcing Ardelyx to negotiate complex reimbursements.
The Kidney PATIENT Act, if passed, will delay the inclusion of oral-only ESRD drugs in the bundled payment system, benefiting Ardelyx until 2027.
Despite the lawsuit loss, bipartisan support for the Kidney PATIENT Act offers hope for Ardelyx's financial stability and tenapanor's coverage.
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Richard Drury

Ardelyx (NASDAQ:ARDX) lost the lawsuit against Medicare, the one that I was worried about in my earlier article. With that loss, XPHOZAH faces the prospect of much reduced and declining revenue. ARDX has no other major prospect in its pipeline, something that has always been a concern. It put all its eggs in that one basket, and now it would have had to pay for that poor gamble. However, the new Kidney PATIENT Act will come to its rescue, at least until 2027, if not longer. It just needs to be quickly passed into law.

Background
Ardelyx has a single molecule known as tenapanor, branded as IBSRELA and XPHOZAH, which targets IBS-C and hyperphosphatemia in CKD patients. IBSRELA was approved in 2022 for irritable bowel syndrome with constipation (IBS-C) in adults. XPHOZAH was approved for phosphate binder refractory DD-CKD patients with hyperphosphatemia.

By the first couple years of launch, these drugs were guided to be making over $200mn (IBSRELA + XPHOZAH) per year, with tremendous intake in market uptake for the drugs. This was facilitated by the lack of effective approved options in IBS-C, and metal overload related safety issues in Hyperphosphatemia. The two markets together were worth several billion dollars, and the company was hopeful that the drugs "can achieve at least a 10% share of the IBS prescription market and as well on the path to becoming a $1 billion product before patent expiry."

All those expectations suffered a major setback when the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS') added tenapanor and other oral-only phosphate-lowering therapies (PLTs) to the bundled payment system for dialysis patients. This canceled their separate coverage under Medicare Part D and moved them to the End-Stage Renal Disease Prospective Payment System (ESRD PPS). The CMS decision to remove XPHOZAH from Part D to Part B affects XPHOZAH for hyperphosphatemia in DD-CKD patients, and not IBSRELA. However, once the new payment system sets in from January 1, 2025, the impact is going to be quite negative.

When a drug is added to a bundled payment system for dialysis patients, it can significantly impact the revenue potential for the drug developer. A bundled payment system comes with a bundled, negotiated price, so the drug may not make as much as when it was separately priced. Moreover, Ardelyx now has to engage in complex negotiations and contracting with health plans and dialysis providers to ensure they are properly reimbursed. XPHOZAH will often not be adequately covered by a single, bundled payment, and that may force healthcare providers to look for cheaper alternatives - there are several approved phosphate binders - like ??Calcium acetate (several prescription brands including PhosLo and Phoslyra); Lanthanum carbonate (Fosrenol); Sevelamer hydrochloride (Renagel); Sevelamer carbonate (Renvela) - that are available as generics, and cost a fraction of what XPHOZAH costs. Of course, they have safety issues that XPHOZAH may not have, but healthcare providers will find workarounds since the drugs are approved.

For various reasons that sound logical but are essentially - and perhaps justifiably - meant to preserve pricing power, Ardelyx sued the CMS for this decision. It was backed by powerful friends - the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF).

Outcome
The matter was dealt with in the District Court of Columbia. As the Court explained, Part B provides insurance for outpatient health services, while Part D provides prescription drug coverage. "All ESRD patients are eligible for coverage under Part B; most (around 80%) have additional coverage under Part D." The incentive for healthcare facilities to opt for Part B for PLTs was that the "facilities could retain any amount of the payment that exceeded their costs." On the other hand, there could be potential misuse of Part D reimbursement because, as the Court noted with the example of Epogen, "Dialysis facilities had an incentive to rely heavily on such drugs because they were separately reimbursable and thus did not come out of the lump sum payment that they could otherwise retain." This was the concern for Congress and created the legislative intent. As the Court stated:

The goal was to remove the incentive for dialysis facilities to rely more heavily on drugs reimbursed on a fee-for-service basis, as opposed to ones included in the bundle, and to motivate these facilities to use whatever combination of treatments would be most effective and economical.

The government also limited judicial review of the bundled payment system. As pertinent parts of subparagraph (G) noted:

There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise of the determination of payment amounts under subparagraph (A), the establishment of an appropriate unit of payment under subparagraph (C), [or] the identification of renal dialysis services included in the bundled payment . .

Thus, when Ardelyx filed a motion arguing that CMS's actions go against Part (B) which describes what oral drugs can fall under the bundled system for ESRD dialysis services, CMS said that "review of that question is precluded by subparagraph (G)."

Bottomline, this is what the Court agreed with. They are basically telling Ardelyx - if you want to change the system, talk to Congress. You cannot directly attack CMS, which is merely implementing what Congress directed it to do.

Ardelyx does just that, and supports the Kidney PATIENT Act, which aims to limit oral-only ESRD drugs from moving into the ESRD bundled payment system. As the American Kidney Fund describes it, the act is a "bipartisan legislation that would delay the move of oral-only ESRD drugs into the ESRD bundle until 2033 or until new intravenous therapies come to the market. The bill would ensure patients have access to the medications they and their doctors have determined work best for them. In addition, the bill would save money for taxpayers because it would delay an increase in the ESRD base rate that determines the bundled payment that would occur when adding oral-only drugs to the bundle."

This bill has bipartisan support and is going to be passed as legislation - however, from my limited knowledge of how the system works, it seems it is still running through the process. Meanwhile, it is being amended to be made even more comprehensive. Bottom line, while Ardelyx may have lost the lawsuit on a technicality, this new bill will ensure tenapanor gets adequately covered.

New SA article out on ARDX by Avisol Capital ...anyone have access to it ?
Kiwi

Hi RMB. They are arguing that the small dialysis centers and minority patients will be adversely affected if the CMS change goes thru on Jan 1st .
Hopefully this moves the needle for a 2 yr extension of the current policy ...while they work out the issues with planned change
I think theres only about 2 wks left in the year for Congress to be in session ....maybe a long shot but fingers and toes crossed
Kiwi

You are good Kiwi.  I saw the letter on ST yesterday but couldn't either get a link for it or copy it to post.  Unfortunately it seems that Congress won't be back working until the first week in Dec and not sure if they will get this done.  As you may recall I am also waiting for the Senate to act on another piece of legislation I am interested in (SS Fairness Act), so pins and needles till the end of the year.  This letter impressed me and if it does not stir those senators to act, I am not sure what will.  Worrying as well that as I am waiting for some of these bios to pay off the general market one of these days is due for a dump - and take all these with it.  Looking to find good exit points on all these by Spring at the latest and hope it is not too late. 

New push in Congress to pass the Kidney Patient Act ,with a lot of backing .
Very positive for ARDX near term if it pass's and also for UNCY when OLC is approved mid 2025

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

Kiwi

Jefferies note ...via Frank on X
$ARDX Jefferies reiterated Ardelyx, Inc (ARDX) at a Buy rating and $11 price target.

-Mgmt is confident it can navigate the various Xphozah dynamics going into 2025 and are optimistic underlying patient demand should grow despite pot'l changes w/ Xphozah reimbursement. We'd also flag the CMS litigation is not completely over as mgmt will likely challenge / appeal imminently and there's still a scenario a PI / stay could happen by YE.
We appreciate there's still near term uncertainty but are confident stock can rebound once we're in 2025.
-Mgmt will move quickly to appeal the motion to dismiss...should hear more by YE. The Judge in ARDX's lawsuit against CMS recently granted a motion to dismiss though the case has not been closed. We think ARDX could file a "motion to reconsider" and point out specific flaws in the Judge's logic. The Judge could reconsider and grant a Pl or summary judgement, or if denied ARDX could appeal to the Circuit, which could possibly grant a stay before Jan 1st 2025 given the imminent irreparable harm. All in all, a Pl could still be possible before YE vs our initial belief that this is no longer on the table.

-The House and Senate bills continue to make steady progress in gaining co-sponsors and mgmt thinks a minibus/omnibus bill package could be possible as a vehicle for YE. HR5074 has gained bipartisan support in both the House and Senate and it's likely such a non-controversial bill could move forward before YE to "clear the deck" for a Republican House and Senate next year.

Also note that the initial bill for a bundling delay until 2033 was proposed by Republicans but Dems pushed for a much shorter 2 year delay. Thus, one could argue a Republican majority in the House/Senate could favor add'l bills in the future to delay bundling. ( my comment ...interesting )

-ARDX is also well-equipped and prepared to preserve volumes if Xphozah enters the bundle in 2025. Xphozah reps are out in the field messaging cont'd access and doctor feedback has mostly been (+). That said, docs need to actually go through the process themselves and importantly for substantially higher volumes to gain confidence Xphozah scripts will still be fulfilled.

Medicare scripts will be adjudicated by ARDX's existing patient assistance program Ardelyx Assist and filled at an external specialty pharmacy. Docs are already using the PAP in a small proportion of patients but key is that the PAP will need to be able to handle many thousands of scripts. The PAP has now been expanded in anticipation of greater volumes with all new staffers already hired, trained, and ready for Jan 1st, 2025, and external vendors are also ready to take on add'I patients.

It's also notable ARDX has continuity of care programs in place that will automatically enroll Medicare patients and provide free drug for 2 months....my emphasis ....good move

-Net net, mgmt is optimistic Xphozah won't face significant disruption in 2025 from a volume perspective though investors are understandably cautious.

Kiwi

Interesting ..thx ...might be a plus for the Kidney Patient Act
Kiwi

Well if ARDX's Ceo sticks to his position and refuses to put Xphozah into the TDAPA process ...then UNCY's OLC may be the only new pho binder available to dialysis patients , once it's approved.
Actually any win for ARDX ( Kidney Patient Act passing , extending time line of adjustment period following TDAPA etc ) ...is a win for UNCY also ( at no cost to UNCY )
So UNCY wins either way ...eventually . Now if they can just get their PPS over a $1 and remove the Naz delisting R/S threat , I'll be a happier camper

Kiwi

Just heard that Dr Oz is going to be head of CMS.  Wonder if it means anthing for ARDX or UNCY?

Hi Free Most of my portfolio is AI related ...NVDA, VRT , VST etc I posted on Biotech Values board recently about APP ...which I assigned to my youngest son when it was $110 ...NEVER expecting its recent run .
Biotechs I like ...RZLT, OCUL , VERA, EWTX ,UNCY etc also had green days .

My feeling about ARDX . I think the Ceo will stick to his current position and wait to see if the Kidney Patient Act gets passed before the EOY. ...which might be a long shot
If it doesn't get enough cosponsors etc and it's pushed into next year ....hopefully he and CMS will negotiate and compromise .

My wife knows of patients on Xphozah who for the first time have been able to get their serum pho to goal . Never happened on the existing binders .
These are Medicare patients that will lose coverage starting Jan ...unless CMS and ARDX compromise ...OR the Kidney Patient act pass's.

I'm betting on an eventual compromise ...as explained in previous posts

Kiwi

Kiwi. Other than some very small reds in my divvy account, the only red beside ARDX today is CRSP and not much by much.

One thing I find a tiny bit funny is that although the deviations are small, it seems often enough that when ARDX is positive, then UNCY is slightly negative and vice versa. Seems a little odd but it could just be serendipity.

Kiwi, what are the non-red winners on your screen :--)

ARDX is the only thing thats red on my screen :--(
Kiwi

RMB. thx for that link . Just watched the presentation .
Ibresla ...expanding sales force , adding new territories , still needs prior authorization ( patient fail first line drug first ) ...but expect mkt to grow

Xphozah ... Hoping the Kidney Patient Act pass's ...5th most looked at legislation currently working thru Congress .
The problem is loss of Medicare coverage starting Jan 1st .
Their non Medicare population is seeing strong up take when covered by insurance ....but non Medicare is only about 40% of the total dialysis population ( at most ) .

They are telling Docs to keep writing scripts for their Medicare patients .
But is IMHO very unlikely MD's will start new Medicare scripts now ...theres at least a 2 wk period where roughly 50% experience diarrhea ...before they adjust to this med ....to only then tell the patient they can't get Xphozah in Jan .
The ARDX assist program doesnt work for Medicare patients ...my understanding .

So Xphozah for Medicare ( 60% of their market ) likely to come to an abrupt end in Jan ( unless the Kidney patient act pass's before then )
If they had applied for TDAPA these patients would still have Xphozah ( and they would make $ for the next 2 yrs with lesser amounts for 3 yrs past that before competing with generics )
But why develop new drugs if U end up having to compete with generics in 5 yrs anyway .
Thats why CMS's plan as currently stands, kills innovation

So its $ stand off game
CMS wants to ultimately limit what they pay for Xphozah by including Xphozah in the bundle in 5 yrs ( 2 yrs TDAPA plus 3 yrs adjusted payments )
ARDX significantly over charges for Xphozah compared to what they charge for Ibsrela ...its the same drug ...but feels its justified due the the cost of the clinical trials etc they have run .

Right now it looks as tho ARDX has no interest in seeking a compromising with CMS ...and rather is betting on the Kidney Patient act and patient / MD advocates . Which may explain todays action

A compromise would be ARDX lowering the price per gm of Xphozah to that of Ibsrela ...in exchange for a longer time period before entering the dialysis bundle


Kiwi

Guess the market didn't think much of the presentation or thinks there is no way Kidney Act passes.  Gonna give Mott a call.  

Kiwi. Listened to the CC this morning. Company seems staunch in their belief that they will be able to continue growth of Xphopah (sp?) albeit whilst taking a bit of hit to revenue. They are in touch with docs and say that the docs are quite aware of the coming situation. https://wsw.com/webcast/jeff315/ardx/1849260

Ha. Not me. Would be nice to know Mott's net worth to know how important his investment here is

There was a million share buy order that went thru ...I figured that was U ..:--)
High risk so buckle up
JMO
Kiwi

I did the same Kiwi this am

RMB. I added this am
My take for what its worth
1) It will be tough to get the Kidney Patient Act passed before EOY . It needs to get added on to something like the Govt continued spending bill with more co sponsors . No impossible but a real challenge
2) DaVita and other dialysis centers are preparing for the shift to storing and dispensing Oral pho binders on site .
Some Nephrologists welcome this as it means they can be sure the patients get these meds . Currently there are problems with pharmacies filling only 1 mth at a time when the patient ask's for a 3 mth fill . If these meds can't be mail ordered the patient often miss's the 1 mth pharmacy pick up .
Dialysis center managers are less enthused ...big hassle for them to order , store , manage supplies .
3 ) For those on Medicare getting Xphozah ..... access to X may be very limited in Jan 2025 forward ...so some thoughts on prescribing Ibsrela instead as discussed in a previous post .
If so we should see an uptick in Ibsrela scripts in early 2025 ...although ARDX will be making less $ then if it were a Xphozah script ...even tho its the same drug
4) Ibsrela scripts for dialysis patients who don't have IBSC would obviously be an off label script . While this practice ( writing off label scripts ) may be frowned on ...it's not uncommon. ( I had an off label script for Vascepa before the R-IT approval for the CAD indication )
5 ) Theres going to be pressure from Nephrologists and patients for a compromise to be worked out here .
Some patients are now able to get their serum pho levels to goal on Xphozah ...where as they couldn't previously on the existing binders .

ARDX can lower the price of Xphozah to be similar to price per gm of Ibsrela in exchange for a longer runway before having to compete with generics
Currently its 2 yrs in TDAPA , then 3 yrs of price adjustment , then compete with generics
They can adjust that to something like 2 yrs in TDAPA , then 6 yrs in gradual price adjustments , then compete with generics

Just my thoughts ...we'll see how they age :--)
Kiwi

Yep thats my take . If it's not enough to get to goal ( each patient responds differently ) add a generic Renvela ( which is cheap ) .
They are testing X in combo with Renvela already .
Bottom line ...there are work arounds if MD's are willing to prescribe off label even tho its the same drug .
Incentive for ARDX to make a deal with CMS and keep everything kosher .
The problem patients have with Renvela is the pill load 2-3 per meal
1 in the am with half a Ibrsela and the same in the pm ....probably the same serum pho lowering as a full daily dose of Xphazoh ...for 1/3rd the cost

Kiwi

Real quick.  Getting 50mg by splitting basically 1159, so significantly cheaper but 10 mg less

RMB. Can U chk my math on this ...thx ...I'd posted on Dews board

Ibsrela and Xphozah are the same drug ...Tenapanor
Ibsrela is for the IBSC indication ...50 mg twice a day = 100 mg of Tenapanor a day
Xphozah is for dialysis patients ...30 mg twice a day = 60 mg a day

A 80 day supply of Ibsrela without insurance is quoted at $2,317
A 80 day supply of Xphozah without insurance is quoted at $4,284

So ARDX is charging dialysis patients / Medicare almost twice as much..... for just over half as much ...of Tenapanor per 80 day period ?

The reason this comes up is that since ARDX is not entering the TDAPA process ...dialysis patients on Medicare ( majority of them ) will lose access to Xphozah starting Jan 1st 2025.
Since some of these patients currently on Xphozah have been able to lower their serum pho levels to goal ....for the first time ( never got there on the existing pho meds ) .....theres some concern about what happens for these patients Jan 1

Now a work around being " whispered " ...is simply to prescribe these dialysis patients Ibsrela instead ...its the same dug and ARDX is charging a lot less for it .
If they prescribe 1 pill of Ibsrela ( 50 mg ) plus a pill splitter ... so 25 mg twice a day ...they get close to the 30 mg twice a day ( 60 mg ) ...for roughly $1,200 ( without insurance ) vs the $ 4,284 ( without insurance ) ARDX is currently charging .

My first run thru on this so I'd appreciate it if others here chk'd my math
Thx
ARDX Chairman of the BOD David M Mott made a very large open market purchase of the stock this week

Kiwi

Sounds plausible.  Wonder if there are examples where Medicare is that amenable.  But have to assume that Mott is not so stupid as to plop that much down on something heading down a dark tunnel.  Although I added last week I may think about throwing a few more dollars at this if I can free some up elsewhere, but nothing excessive.  Good luck to us all. 

RMB well I'm hoping CMS and ARDX compromise over Xphozah
ARDX can lower the price of Xphozah to be the same per gm as they charge for Ibsrela ...its the same drug Tenapanor
CMS can extend the time period before Xphozah is forced to compete with generics in the dialysis bundle .

So what might force this compromise ?
As it currently stands Medicare patients on dialysis will lose access to Xphozah on Jan 1st as ARDX has not entered the TDAPA process ...which as currently set up would mean X having to compete with generics in the dialysis bundle within 5 yrs .

Meanwhile some dialysis patients who were never able to lower their serum pho levels to goal on the current pho meds ....have been able to on Xphozah .
So there are now some " whispers " in the Nephrology community suggesting that if Xphozah is not available ....just prescribe Ibsrela ...since it is the same drug ( just different dose levels for IBSC patients )

This would probably be an " off label " script since even tho its the same drug ...Tenapanor ....it's for a different indication IBSC

ARDX is over charging dialysis patients / Medicare as I've stated before .
The price for Xphozah is roughly 40%-50% more per gm then what they charge for Ibserla ....even tho its the same drug
They can lower the price to match Ibsrela per gm in exchange for a longer runway in price adjustments following TDAPA before they have to compete with generics in the dialysis bundle .

I think that where this is going and the only reason IMHO for Mott who is chairman of the BOD would make such a large open market purchase last wk.

JMO
Not investment advice
Kiwi

Thanks for all that insight Kiwi.  Have to assume Mott knows something about the path they will take going forward. I would feel better if the Kidney Act passed Congress. . 

RMB. yes I think so . re Insider Mott ...Chairman of the BOD large insider buy
An update . My wife prescribes these med ( serum pho lowering ) to her dialysis patients . We were on a drive today and normally she doesnt like to talk much about work related issues ...but trapped in a car with me for an hr or so she relented .
Her view is that Xphozah is way over priced ...something I agree with when U compare to what ARDX charges for Ibsrela ...same drug ...for IBSC
She does acknowledge that it works ...one patient in particular with high serum pho levels on the available meds was able to lower pho levels to goal.. on Xphozah .
Patients on current pho meds complain of constipation so since Xphozah causes diarrhea for some ...and a loose stool for others ....there is an interest in trying X to not only reduce pho when the other meds don't ...but for some to also give them more normal bowel mvts.

She would prefer these meds to be distributed by the clinics she rounds so as to be sure the patient actual got the med . To often there are issues with the pharmacy wanting a reauthorization every mth !!!
There is real concern about starting dialysis patients on Xphozah now ...when it may no longer be covered for Medicare patients in Jan

The current process is for the new oral pho drugs to start TDAPA in Jan ...so would be covered for 2 yrs ...then at a reduced rate for 3 yrs after that ...and then finally have to compete with generics in the dialysis bundle when the full 5 yrs was up .
I think theres a consensus developing that no new oral pho drugs will be developed going forward...if they are forced to compete with existing generics in 5 yrs

ARDX can lower the price of Xphozah by about 1/3rd to cost the same per gram as Ibsrela ( it's the same drug ) ....and I speculate they may do that in exchange for more years at higher pay out coverage .
This is similar to what happened with the launch of Repatha ( I drug I take )
On launch it was $14,000 a yr and few scripts were approved .
2 yrs later after extensive negotiations they lowered the price to around $6,000 a yr in exchange for easier script approvals
Where as I was previously denied this drug even tho I meet all the profile requirements ...I can now get it for a $1,800 a yr copay ( $150 a mth )

I think / hope they will do something similar with Xphozah and UNCY's OLC ....and was buying both back on Friday
JMO
Not investment advice
Kiwi

Wonder what his thinking is.  Does he think even without passage of Kidney Act that there is still a path forward for ARDX?

Big bet by an insider ...open market purchase David M Mott
http://archive.fast-edgar.com/20241114/AWZZ3Q2COZ22UZ3Z2C9N2ZZ2P4KUZ22IZY62/


David M. Mott is a prominent figure in the biotech investment landscape, with a long and successful career spanning over three decades. Here's an overview of his biotech investments and career:
Investment Career
David Mott is currently a private investor through Mott Family Capital12. Prior to this, he served as a General Partner at New Enterprise Associates (NEA) from 2008 to 2020, where he led the healthcare investing practice25. During his time at NEA, Mott oversaw $1 billion in health care venture capital8.
Board Positions
Mott holds several chairman positions in biotech companies:
Chairman of Adaptimmune since January 20174
Chairman of Ardelyx, Inc. since 200812
Chairman of Mersana Therapeutics since 201312
Chairman of Novavax, Inc. since June 20202
He previously served as chairman for Epizyme and Imara, Inc.12
Notable Investments
Throughout his career, Mott has been involved in numerous biotech investments, including:
Sagimet Biosciences
Cydan
Nightstar Therapeutics
Vtesse
XTuit Pharmaceuticals
Clementia Pharmaceuticals3
Industry Experience
Before his investing career, Mott held executive positions at MedImmune:
President and Chief Executive Officer from 2000 to 2008
Various roles including Chief Operating Officer and Chief Financial Officer from 1992 to 200012
During his tenure at MedImmune, Mott led the sale of the company to AstraZeneca in June 2007 for $15.6 billion1.
Investment Impact
Mott's expertise in the biotech sector has led to significant achievements:
Involved in more than $40 billion in corporate acquisitions, fundraising, and partnerships
Supported over 35 initial public offerings or corporate acquisitions
Brought more than a dozen new drugs through development to commercialization
Served on 25 corporate boards1
David Mott's extensive experience and successful track record have established him as a key figure in biotech investing, with a particular focus on venture capital and growth equity investments in the healthcare sector.


Kiwi

From Frank on X re Kidney Patient Act
$ARDX H.R.5074 added two more co-sponsors yday
-Rep. Hayes, Jahana [D-CT-5] 11/14/2024
-Rep. Pingree, Chellie [D-ME-1] 11/14/2024

Kiwi

Ardelyx Insider Bought Shares Worth $996,598, According to a Recent SEC Filing
MT Newswires

Kiwi

Jefferies report out ...Think theres a chance the Kidney Patient Act bill will be added onto one of the must pass bills before end of yr ( Govt spending bill etc ) and even if not , Ibsrela scripts are growing and they will still make $ off non Medicare Xphozah patients .
Apparently 2 more cosponsors also added to the KP Act
Kiwi

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.