Ardelyx Inc (ARDX) News

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

If it doesn't pass it is a crying shame.  Something I believe the vast majority of the population would approve of.  

Yep, my take as well.  That is why I questioned those rejected scripts since they sounded like they would have absorbed cost.  This is out there so I would hope that it is priced in but you know when news story comes out there is a knee jerk reaction.  Or sometimes after the stock moves one way or another then they write the story offering up reasons 

RMB. listened to most of presentation .
Passage of the KP Act looks unlikely this yr . Reconsideration by Judge a long shot . Will provide free Xphozah where needed and write off as a marketing expense .
Ibsrela doing well but still 2nd line therapy . No decision in China till 2025 .
Overall pretty negative / cautious . Question is has market priced all this in .
Kiwi

You are correct that there was no mention of the drug being overpriced.  

RMB. I believe the scripts are monthly . Nephrologists and pharmacies want to make certain these patients have some pho lowering med waiting for them Jan 1st
They are not inclined to mess with patient assist programs for Medicare patients in this instance . They are overwhelmed already and are frustrated by the hurdles they have to jump over just to get the patient the best meds available. These patients are on multiple meds .

Yes Nephrologists are very frustrated with the changes set to take place . Initially it will make their jobs harder . Longer term it may mean better patient management but only if they have access to the best drugs available ...at co pay prices patients can afford.

Nephrologists may be p'd at the system ...they also think ARDX is ripping off dialysis patients and the Medicare system by over charging for Xphozah ...compared to what they charge per gm for Ibresla ( its the same drug )

Guess they didn't mention that at the fireside chat

Kiwi

Kiwi, I have a question for you. I listened to most of the fireside chat today with Piper Sandler. Overall I thought they were hopeful but slightly resigned to the chance that the KPA does not pass before the end of the year. And discussing the "what if it doesn't pass", they kept emphasizing that they wanted to make sure the patient had access no matter what. I think they called it "patient assist" or something like that. They indicated that they would subside the cost for the patient if need be (the finance guy said it would go to SGA when questioned about how it would affect Q1 revenue).

So my thoughts drifted to your commentary the other day relating the experience of your wife and those denied scripts. Did no one contact Ardelyx to have them assist with getting those scripts? That is what they are saying in all these conferences that they will make sure patients still get their meds. Side note, there was a mention that nephrologists are apoplectic concerning all these rules going into play on Jan. 1.

I'm hanging in there mainly because of this
Thursday, November 14, 2024 7:00:26 PM
Post# of 1717
Ardelyx Insider Bought Shares Worth $996,598, According to a Recent SEC Filing
MT Newswires

He's the Chairman of the BOD so eventually I'm guessing , at least a deal will be worked out

Now if Denner did this I might buy back into AMRN. :---)

Kiwi

Yeah this is crazy.  Between the scripts being denied and Ernie reminding me of the gooberment, I lightened up the other day. 43 sponsors.  Heck my SS Fairness Act has 330 sponsors and still waiting for the Senate to act.  SMH. 

3 new co sponsors ( 1 is Republican ) for the Kidney Patient Act . Total of 43 cosponsors now . An informed opinion I'd read on these bills is that you need at least 50 co sponsors to tilt the scales towards passing the Act
Still about a week and a half before they shut down for the yr
Kiwi

More info on the 2 yr TDAPA process and the 3 yrs follow on

CMS is currently considering a modification in its bundle incorporation process for those products placed in an existing functional category after completion of the TDAPA period.
Following the 2 years of TDAPA, CMS proposed a 3-year add on payment at 65% of expenditure levels for these products. This incorporation adjustment was limited as CMS argued that existing dollars in the bundle are associated with the treatment of these conditions.

Some stakeholders have countered that the 35% reduction is arbitrary, does not consider competitive dynamics, and does not reward innovative products.

Kiwi

Cosa ...method of use patents
April 10, 2034
Patent use: TREATMENT OF HYPERPHOSPHATEMIA

April 10, 2034
Patent use: REDUCTION OF SERUM PHOSPHORUS IN ADULTS

What I meant about competing with generics if Xphozah is included in the dialysis bundle as its currently planned .

The dialysis bundle CAPS the payment for each dialysis session IIRC to about $270 . This includes everything involved .
Currently Xphozah is billed separately .
If ARDX enters the TDAPA process Xphozah will be covered as it now is ....as an additional payment for 2 yrs .
For 3 yrs following that CMS will adjust ( I assume downwards ) the price they will pay separately for Xphozah .

After 5 yrs there will be no extra payments for Xphozah . Xphozah will need to be paid for out of the payment per dialysis ...currently around $270 .
There is not enough money to pay for everything involved with a dialysis session AND pay for Xphozah at anywhere near its current ( roughly ) $3,100 a month cost .
Patients will be forced back on generic pho lowering drugs which are very cheap ....although 40 % of the dialysis population never get to serum pho goal using them and most patients hate them .
( by the way this is starting to happen already since at present Xphozah won't be available to Medicare dialysis patients Jan 1 . New Xphozah scripts are being denied and replaced by generic Renvela )

ALSO. the way the dialysis bundle works ...dialysis providers get to keep any $ left over between what CMS pays them per session ...and what it costs them per session . So theres a financial incentive already to prescribe cheap less effective generics

Kiwi