Ardelyx Inc (ARDX) Options

Cosa Xphozah is way over priced per gm compared to Ibsrela ...it's the same drug Tenapanour . They can always try and negotiate a deal ....access to market in exchange for lower price ...just as Amgen did with Repatha .
ARDX's mgt will be under pressure to make a deal before UNCY's OLC is approved ( mid year ) .
UNCY will apply for TDAPA so OLC will be the new pho lowering drug on the market around late 2025 ....UNLESS. ARDX makes a deal with CMS first .
JMO
By the way ...a new trial has been launched using Xphozah for those with Parkinson's experiencing constipation .

Kiwi

Ofc it was coordinated. US is one of the most corrupt nations lol.

ARDX has been battling against political set backs from delayed FDA approval, now to CMS. It makes you wonder if the delayed approval was orchestrated to prevent Xphozah from gaining traction before the bundle went into effect. Then there would have been a much greater patient base getting cut off from meds proven to work better than SOC. Management has made good decisions so far. They must defend the right for drug discovery and compensation.

From Frank on X

$ARDX - Filed their official appeal with the United States Court of Appeals for the District of Columbia Circuit.

Key Legal Issues
1. Statutory Overreach by CMS – Plaintiffs contend that CMS exceeded its authority under the Medicare Improvements for Patients and Providers Act (MIPPA) by expanding the definition of renal dialysis services beyond Congress's intended scope.

2. Negative Impact on Innovation and Patient Care – The inclusion of oral-only drugs in the ESRD PPS bundle allegedly discourages dialysis facilities from adopting innovative treatments, reduces patient access, and worsens health outcomes.

3. CMS’s Misinterpretation of the Law – Plaintiffs argue that CMS misread 42 U.S.C. § 1395rr(b)(14)(B) to include all oral-only drugs, whereas Congress only intended for oral drugs equivalent to injectable drugs to be included in the bundle.

4. Judicial Review Preclusion Does Not Apply – CMS argues that judicial review is precluded under the statute. However, Plaintiffs assert that CMS’s redefinition of statutory terms is not subject to this preclusion.

Relief Sought
Plaintiffs-Appellants request that the Court of Appeals reverse the district court’s ruling and declare CMS’s rule unlawful. They seek:

1. A ruling that oral-only drugs should not be included in the ESRD PPS bundle.

2. Reinstatement of separate Medicare reimbursement for oral-only drugs.

3. Legal clarification on CMS’s authority regarding Medicare reimbursement rules.

CMS response due 3/6

Kiwi

Believe ARDX has filed an appeal vs the CMS ruling on Xphozah in the dialysis bundle
CMS response due mid March
Kiwi

Some follow up on the TDAPA process
If Xphozah's WAC during TDAPA were $100 per unit, the post-TDAPA payment adjustment would be calculated as
65
%
×
100
=
65
65%×100=65 per unit.
This adjusted payment would apply across all ESRD PPS payments for three years, with case-mix adjustments potentially modifying the final amount12.
However, it is important to note that this post-TDAPA payment is distributed across all dialysis facilities, not just those prescribing the drug. This dilution effect could result in inadequate reimbursement for facilities using Xphozah, potentially limiting its availability and adoption3.

I have yet to work out how they resolve this

Kiwi

Doing some reading on the TDAPA process and noted the following today
After the TDAPA period ends, CMS may implement a post-TDAPA payment adjustment based on 65% of the estimated expenditure levels from the prior year to ensure continued access to innovative therapies24.
This structured approach ensures that new therapies are temporarily reimbursed outside the bundled payment system while CMS gathers sufficient data to incorporate them into the ESRD PPS framework.

The TDAPA period is what the Co bills , or WAC ( wholesale acquisition cost ) and runs at least 2 yrs .
After that 65 % of what that price is ....I dont know if it continues at that level or tapers down from there .
If it continued at that level it would be roughly on par with what they charge per gm for IBSRELA ...its the same drug Tenapanor .

Seems like a deal that could work ....full price for at least the first 2 yrs ...then equal to per gm cost of IBSRELA after that

Kiwi

If UNCY's OLC is approved by the end of June 25 , it will probably have CMS coding and in the TDAPA process by end of October.....and be the new serum pho lowering drug available to Medicare dialysis patients .
ARDX needs to work out a deal with CMS before then for Xphozah . Currently XPHOZAH is not in TDAPA and is not being covered for Medicare dialysis patients ...beyond those in the Co's assist program ..
I'm in both ARDX and UNCY .
UNCY is high risk as they only have till July 11th to regain Naz compliance .....and still need FDA approval ( PDUFA date I think is June 28 ) .......but their drug OLC is 1/3rd of the cost of Xphozah , doesnt have a diarrhea issue and is supposed to be more tolerable then Fosrenol due to its extra O2 molecule .
The other issue with UNCY is their limited exclusivity .

ARDX still has to make a deal for EU sales , has better patent protection and hopefully will make a deal with CMS for the US Medicare population .....which is why I still own the stock

Kiwi

Saw a post on ST where the poster indicated that in the last full week of 2024, the script number was 1564 ( including CMS), whereas the first full week in Jan 2025 the scripts were 949. Not bad really. Maybe when the stock was dropped below 5 a few times, all that loss of CMS was fully discounted, maybe even more. The poster is not totally correct with his assumptions about cost, etc., but I thought the 949 was pretty good. Now how much of that was where the company basically picked up the cost for the patient? That is the big question.

https://stocktwits.com/watsonturtle/message/601265072

Maybe the insider purchases indicate they are comfortable or happy with what they are seeing here in 2025.

Recent Open Market purchases by the Chairman of the Board ...David Mott
On December 19, 2024, Mott purchased 213,300 shares at an average price of $4.6722, for a total amount of $996,58034.
On November 13, 2024, he bought 215,868 shares at an average price of $4.6167, totaling $996,5983.
Including todays purchase = roughly $3m in purchases since Nov 13th
Believe as an insider he can't sell these until 6 mths past date of purchase ...SEC ruling
Kiwi

Well at least someone likes ARDX at these prices
http://archive.fast-edgar.com/20250122/AWZZ322CO222U242222O2MZ2N4KMZ22IS472/

Is that about a $1m open market purchase ...in addition to his previous ones

Kiwi

Well I would have liked to know what they are doing to resolve their issue with CMS over the dialysis bundle ......they are now effectively shut out of 60% of the US dialysis market ...and those patients have limited access now to XPHOZAH .
So thats the potential upside surprise .....a deal to access that market , and a UK / EU deal or entry
Kiwi

Thanks for posting. 

From todays JPM presentation
$250 m cash on hand
IBRSELA ...30% growth in scripts Q4 vs Q3 due to expansion of sales force ..now 120 reps
Prior Approvals still apply but strong demand

XPHOZAH
220,000 non Medicare dialysis patients need serum pho control ....40% of total dialysis population
This is the patient population currently available to them .
Some Medicare patients getting XPHOZAH for free

EU ..Co now has a dedicated effort to sell or partner to sell in the EU .
Rest was just soft ball questions .
No one asked about potential negotiations with CMS to resolve the dialysis bundle issue.

Kiwi

I'm done with DD on this one. I'm in and just waiting now. Simple as that...

Whats up with EU / UK approval and / or sales of both drugs . Any up date on that ...anyone ?
Kiwi

If they creep up on those numbers in the next few years the market cap will move to $6 -$10 billion eventually.

Their guestimation:

Company reaffirms peak U.S. net IBSRELA sales revenue of greater than $1 Billion

Company announces peak U.S. net XPHOZAH sales revenue of $750 million

Their Medicare sales will drop off a cliff ...that is well known . But Medicare is 40-60% ( depending who you read ) of their Xphozah sales ...its not all their sales .
Non Medicare is apparently showing strong growth as well as Ibsrela
Kiwi

Sure, but market is supposed to be forward looking and the anticipation is that Xphozah sales are going to drop off a cliff

IBSRELA® (tenapanor) records approximately $158 million in net product sales revenue in 2024

Strong XPHOZAH® (tenapanor) performance continues, recording approximately $161 million net product sales revenue during 2024

Strong Cash Position
As of December 31, 2024, the company had total cash, cash equivalents and short-term investments of approximately $250 million (unaudited). Ardelyx had approximately 238 million shares outstanding as of December 31, 2024.

https://ir.ardelyx.com/news-releases/news-release-details/ardelyx-provides-update-increasing-commercial-momentum-and-2025

Another strong day for the stock price today whilst the overall market wasn't the greatest. Company issued a PR this morning highlights strong sales and estimates for peak sales for the two drugs. But realistically did not address what sales for X will be now in 2025 other than to say that it is not covered by Medicare and they will evaluate patients to see if they can help financially if a script is written. Hard to know what is behind the strength of stock price of late.

My understanding is that the few patients on Xphozah ( they had to show intolerance to existing pho binders ) are no longer getting Xphozah .
This was a pharmacy decision ...they are now dispensing Renvela and maybe Fosrenol instead .
I believe they planned on switching over to dispensing oral pho drugs from the dialysis clinics but dont know how much of that has occurred yet
ARDX is presenting at JPM health conference

Hey Kiwi, Did the facility your wife works at start carrying and distributing oral phosphate binders since the new year?

Jefferies analyst Chris Howerton maintains Ardelyx ( ARDX ) with a Buy and lowers the price target from $11 to $8.

Reflecting loss of Xphozah sales in Q1 ...I assume

Kiwi

Nice work if U can get it
http://archive.fast-edgar.com/20241227/AWZ7322COZ22UJ5222JO2ZZ2S4KBZ22IS262/

Option exercise ...purchasing 100,000 shares at 55c a share

Kiwi

This whole scene is ripe for an Amgen / Repatha deal with CMS .
Amgen wanted $14,000 a yr for Repatha ...and few patients were covered .
After 2 yrs Amgen agreed to lower the price to $6,000 ( roughly ) a yr in exchange for removing the strict PA's ( prior approval; ) and more widely cover .
End result is that I'm now covered and Amgen is making $ selling Repatha ....far lower profit per script but far larger number of scripts filled.

Same deal could apply to Xphozah which is ridiculously over priced per gm compared to Ibserla ( Its the same drug Tenapanor )
Extend the time following the TDAPA process ,where the price paid is adjusted downwards , by several years ...in exchange for a lower price per script especially for Medicare dialysis patients ( who are about 60% of those using Xphozah )

Kiwi

Another good showing today by ARDX whilst many stocks got hammered today.  Good sign. Mott keeps buying - another hood sign. 

Raggy .....RGTI. OMG ...Do U still own it ?

Kiwi

Chairman Mott buying again http://archive.fast-edgar.com/20241223/AWZ7322COZ22U28222JN2WZ2V4KBZ22IS262/

Previous purchase was 11/13 ....215,868 shares at $4.6
Now 12/19 ... 213,300 shares at $4.67

Kiwi

Do you think data for NSCLC is far behind?  Pancreatic cancer is a bitch, and I think NSCLC offers more hope for success. 

They should have a readout 1st quarter 2025 on pancreatic.

Do you know when CADL's next data readout is? Wasn't clear at all from their last corporate presentation or quarterly report

Yep, I can vouch for your heads up on CADL.  Had to do some reshuffling in a porfolio but picked up shares yesterday when I stopped in a rest area when driving back from Vancouver.  When I saw what it did today I regretted not jettisoning everything in the portfolio and dumping it all onto CADL.  TY 

Kiwi, I sold the bulk of QUBT today just under $20. I also mentioned CADL to rosemount in the last day or 2. Check it out. Up nicely today, but seriously, it is going to $50 in 25. Just had a successful read out on a P3 that had an SPA with the FDA for prostate cancer. Just completed an offering. The chairman of the board just bought 1.25M shares at $6, so I followed his lead. I haven't had a chance to check out ARDX today. Glad it's up. Still think it's a big winner once we get past CMS.

I got some Jan 2026 calls the other day. Hopefully it is all figured out by then. Have not added any more shares, I'm good with what I'm holding already.

With you Kiwi.  Holding what I have.  They have 2 growing drugs albeit that may slow down dramatically but who knows. 52 week low hopefully we stabilize here. All this crap when I am away from home. Up in BC visiting BIL 

Well so much for my opinion posted earlier , that the probable failure of the Kidney Patient Act to pass this yr , was largely priced in .
I added some at $4.4 and will likely forget about ARDX until next yr

Kiwi

Thanks Raggy, I will check it out.  Hopefully everything bad is now discounted with ARDX

Raggy ...U are making to much $ elsewhere ...I'm thinking of banning U from this board :--)
Congrats on your AI / Quantum picks
I'm in PLTR and SOUN .....but QUBT , QBTS , RGTI ...I looked at and thought " not ready for prime time "...whoa ...did I F that up

Kiwi

My quantum stocks saved the day from being bad. I do think it reverses rather quickly, but biotech in general is in the crapper. A new position for me is CADL. A patient in my MIL's office works in management. They just hit on a drug that had SPA. Prostate cancer...just had a capital raise after the successful p3, so that's out of the way. Thought you might want to check it out. I will probably selloff some AMRN and move it there. I like the risk reward and they have another readout in 2025.

Looks like the market voted today.  Sad day for ARDX

Thanks Raggy.  I have seen some people mentioning an omnibus healthcare and negotiations going back and forth but haven't seen that they were ready to include the KPA.  Few days left and i am resigning myself to it not getting enacted.  Just hoping that not too much is built in into the stock price at this point.  I would rather hang on to the stock. 

rosemount, it looks like some omnibus healthcare bill is going to be passed in the next few day. The question is does the KPA get included in it. As of this writing, it's not listed, but if it gets on and passes, ARDX will fly.

Picked up another co-sponsor yesterday, up to 44 right now. Unfortunately time running out. Majority leader Schumer yesterday stated that he will bring up another piece of legislation I am interested in up for a vote before the end of the year (SS Fairness Act) but no news concerning the Kidney Act.

Hello Nephrology article yesterday

Phosphate binder rule is disease-specific discrimination

Add topic to email alerts
In April, CMS issued guidance for the inclusion of oral-only drugs in the end-stage renal disease bundled payment. The directive included Xphozah as a renal dialysis service.

Xphozah, (tenapanor, Ardelyx) is a first-in-class phosphate absorption inhibitor approved to lower serum phosphorus levels for adults on dialysis. CMS intends to include the agent in the ESRD prospective payment system effective Jan. 1, 2025, but unlike calcimimetics and phosphate binders, tenapanor will have its own transitional drug add-on payment adjustment (TDAPA) and be excluded in the calculation for a permanent add-on payment. Under this guidance, tenapanor will be moved from Medicare Part D to Part B, and Part D pharmacies will no longer be allowed to fill prescriptions to Medicare ESRD beneficiaries.

Premila Bhat, MD, FASN, AHSCP-CHS, and J. Ganesh Bhat, MD, FASN
Tenapanor in phosphate control
Hyperphosphatemia and metabolic bone disease are the most challenging clinical issues facing nephrologists who treat patients on dialysis. Phosphates are ubiquitous in the diet, and normal kidneys excrete most of the phosphates absorbed from the gut. With the decline of kidney function, phosphates accumulate in the blood, leading to secondary hyperparathyroidism and metabolic bone disease.

Since dialysis became a routine procedure for patients with ESRD, traditional management of elevated phosphorus has been through oral drugs that bind phosphates and prevent absorption. Aluminum hydroxide gel and calcium-containing compounds, such as calcium acetate or citrate, were the mainstay for controlling hyperphosphatemia in dialysis. Aluminum toxicity and concerns about calcium burden led to the introduction of other phosphate binders, such as sevelamer carbonate, sevelamer hydrochloride, lanthanum carbonate and iron-based phosphate binders.

Premila Bhat, MD, FASN, AHSCP-CHS
Premila Bhat
J. Ganesh Bhat, MD, FASN
J. Ganesh Bhat
Dietary restriction and dialysis using currently available dialyzer membranes alone are insufficient to maintain phosphate balance; hence, there is a need to bind phosphate in the gut to prevent absorption. Compliance with conventional phosphate binder therapy is difficult and directly attributable to the “pill burden” and need to take the medication with or soon after meals multiple times a day. Gastrointestinal adverse events and intolerance to the binders further complicate the matter.

Many patients on dialysis cannot maintain a serum phosphorus level between 3.5 mg/dL and 5.5 mg/dL even when using medications to manage the condition. The addition of tenapanor as an add-on therapy for patients who have an inadequate response to phosphate binders or intolerance to any dose of phosphate binder would make these goals easier to achieve and prevent complications due to secondary hyperparathyroidism.

Legal action
In July, Ardelyx started legal action arguing that CMS did not have the authority to include oral-only drugs, such as phosphate binders and phosphate absorption inhibitors, in the bundled payment system. From a mechanism-of-action point of view, Ardelyx argued, these drugs should not be labeled as renal dialysis services because the drugs are not administered either orally or parenterally during dialysis treatment, and a parenteral form of phosphate binder or absorption inhibitor is unlikely to be developed.

The judge dismissed the case on Nov. 8. CMS will move the drug from Medicare Part D to Part B as planned on Jan. 1, 2025. Ardelyx has yet to accede to CMS’s request for it to apply for a Healthcare Common Procedure Coding System code and TDAPA status, leaving dialysis providers with no clear pathway to be reimbursed.

CMS stated that moving phosphate binders from Medicare Part D to Part B improves beneficiary access to these medications. Medicare Part D enrollment among patients with ESRD had increased to almost 80% in 2021, and twice as many patients with ESRD qualify for low-income subsidies as those without ESRD. Medicare seeks to improve access to these drugs to all patients with ESRD under Part B, and moving phosphate binders to Part B from Part D would have a negligible impact on access to these drugs. However, this change would burden dialysis providers to procure the drugs be the gatekeeper, keeping an eye on the cost.

Equity in ESRD
ESRD is one of the clearest examples of racial and ethnic disparity in health care in the United States. Black and Latino patients are affected by ESRD four times and 1.3 times more, respectively, than white patients. Furthermore, poverty, as measured by dual eligibility status and low-income subsidies, makes ESRD the poster child for disparity in health care in the country. Since the introduction of the ESRD bundle, CMS has experimented with ineffective ideas, such as TDAPA and transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) and mandatory ESRD Treatment Choices model, which have an enormous and often negative impact on the lives of patients with ESRD.

Under the current method used by CMS, innovative drugs and technologies are less attractive to innovators and investors, limiting access of patients with ESRD to the advantage of these drugs and technologies in stark contrast to patients who have cancer or heart disease.

For example, Korsuva (difelikefalin, Cara Therapeutics) is a novel anti-pruritic drug that could have treated severe itching for one of six patients on hemodialysis. After the TDAPA period for the drug ended, CMS adopted a 3-year adjustment that spread the cost of it across all Medicare treatments. To recover the cost of providing the drug to a single patient, a facility would have to treat hundreds of patients who do not require it. No facility has a sufficient patient population to make that equation work. Consequently, only a fraction of patients who would have benefited from the drug are now receiving it, and its future availability remains uncertain.

Under the current bundled payment and drug designation process, CMS has reinforced systematic discrimination against patients with ESRD that the administration has indicated it seeks to end. The current system stifles innovation and puts the financial burden on dialysis providers to bear the full cost of providing these expensive drugs and technologies to patients without adequate reimbursement.

Patients with ESRD are discriminated against with regard to access to novel therapeutics, devices and diagnostics compared with their peers without ESRD. Oncology, cardiology, diabetes and patients with other rare diseases enjoy a rich innovation pipeline due to a reimbursement system that rewards companies for innovating in these therapeutic areas. It is time for Congress and other policymakers to revisit how innovation is sustainably paid for in ESRD to ensure brave patients are not left behind.

For more information:
Premila Bhat, MD, FASN, AHSCP-CHS, is CEO of Tidal Home Dialysis LLC, and a partner at NY Kidney Hypertension Medicine in Ridgewood, New York. She can be reached at pbhat@atlanticdialysis.com.
J. Ganesh Bhat, MD, FASN, is a principal at Atlantic Dialysis Management Services LLC, in College Point, New York. He can be reached at jbhat@atlanticdialysis.com.
Published by:
nephrology news and issues logo
Sources/DisclosuresCollapse
Disclosures: The authors report no relevant financial disclosures.


Kiwi

RMB Most of my investing interest is around applications of AI and how that may drive productivity ....That theme ...AI increasing productivity is whats driving PLTR , APP, SOUN , AMZN etc . I use wide stops for risk management ...as example I am prepared to allow these to drop 20% before I'll sell half and then spend some serious time trying to decide to sell the remainder or reinvest when what ever has caused the sell off, pass's.
I try to avoid trading for short term profits .
I tend to " sell the news " tho on biotech ...and that might apply to ARDX IF the Kidney Patient Act were to pass this yr.
EWTX is due to release some P 2 data ...will probably sell that depending on how it trades on the data .
Good luck
Kiwi

Those tech stocks of yours have been roaring this week.  Like I may have mentioned I did make a little coin twice in PLTR and would re-enter on a pull back but they all seem at sky high valuations right now.  Of course we know the market can stay irrational longer than I can stay solvent.  Longer term not all those companies in those industries will thrive but for the time being investors are betting on all of them. Of course you have got plenty of profit in them and I know you wisely use money management and cull profits when appropriate.  Today I have been shopping buying oil stocks where there is blood in the streets.  Eventually they will revert and in the meantime I can collect divs. Thanks for news on ARDX and UNCY. 

OT. RMB just an FYI . I'm heavily in Tech . I have positions in ARDX, UNCY , VERA , RZLT etc because my wife prescribes to these patients .
But my biggest positions by far are in Tech ...... AMZN , PLTR , APP , SOUN etc and some tech funds like FSELX , FSCSX .
I'll update ARDX and UNCY whenever I see developments
Good luck
Kiwi

Thanks.  Seems to be buoying up the sp

I think theres a new co sponsor in the Senate plus X in Japan is now around 10% of all serum pho lowering drugs for dialysis patients ( from a quick scan of the ARDX twitter feed )
Kiwi