Ardelyx Inc (ARDX) ニュース

IMO It should be extended for the life of patent until generics are available.

The patient should have access to whatever drug works best for them. Whether it’s a binder or blocker. The government is over stepping their boundaries from political lobbying in favor of companies to profit. Rather than letting professional rheumatologists and nephrologist do what’s best.

As much as you are correct in your assessment, depending on politicians is not a great business strategy.

100%
It’s the revenue growth that is making me bullish here. They did $300M+ in 2024. They crushed all analyst predictions. With the CMS bs, need to see Q1 numbers to see how much revenue growth slows down. Ironically Xphozah started out pacing Ibsrela out the gate but last quarter showed strong Ibsrela growth. Which could be off label subscriptions as Kiwi brought up.

Cosa. I agree that drug Co's must be incentivized to develop new drugs .
One win win is for ARDX to lower the price of XPHOZAH and the CMS to extend the TDAPA time line so that the Co recoups their costs and hopefully makes some $ .

Binders vs blockers
Patients dont care .
All they care about is
1) does it work and can I tolerate it
2) is it available and can I afford the copay

Kiwi

Cosa - "So politicians need to fix it" - you said a mouthful there.  Were you following the Kidney Patient Act last year? So many sponsors and so many groups lobbying for it and they couldn't get it across ghe finish line last year. 

As much as you are correct in your assessment, depending on politicians is not a great business strategy.  

Its not a great deal if you have spent millions running clinical trials for use in dialysis patients ...thats why they are fighting it .

Exactly... So politicians need to fix it. They're causing the lack of access to new drugs.

The price is fair for the newest FDA approved drug for that condition. It doesn't matter if it is the same drug, they spent millions of dollars on trials and studies to get it there. If these studies were not done, no one would know it could be used for that.

They need to fight the fight or new drug discoveries is done. Do you think there will be new studies for lowering serum pho another company stands to lose millions of dollars? No. This will be the last FDA approved drug if that's the case. ARDX is in a position of strength. There will be no new discoveries.

OLC is still a phosphate binder. Xphozah is not a binder it is a blocker. Big difference.

The current TDAPA process works roughly as follows . For the first usually 2.5 yrs ( at least 2 yrs ) ARDX gets full price for Xphozah . For the following 2-3 yrs the price paid gets tapered down closer to existing generics .
Its not a great deal if you have spent millions running clinical trials for use in dialysis patients ...thats why they are fighting it .

If they do nothing ....are unable to get a comprise from DMS such as extending the TDAPA process or simply refuse to start the current TDAPA process...they lose the Medicare dialysis patient population almost completely . Medicare dialysis patients are roughly 60% if the total dialysis population.

ARDX can lower the cost of Xphozah ( its way over priced compared to IBSREA which is the same drug just different dose ) in exchange for an extended TDAPA process . Amgen ? did this years ago with Repatha ....cutting the price roughly in half in exchange for wider access.

If it was up to patients ...based on the feedback I get . The ideal combination is one Xphozah pill in the morning and one OLC pill at night .
OLC is the most effective at lowering serum pho but some nausea at full dose .
Xphozah at full dose causes many to experience diarrhea ....half dose it relieves the constipation many of these dialysis patients complain of ...but little to no nausea.

Meanwhile ...if you can't get Medicare to cover you for Xphozah , get your Nephrologist to write you a script for IBSRELA with a pill cutter . Take half of 1 pill in the am and the other half in the pm and save everyone a lot of $.
Of course ARDX would be selling a lot less Xphozah ...but IBSRELA scripts will jump ( however ARDX would make less $ then if it was full priced Xphozah )

Kiwi

How is this good?

Once TDAPA ends and the drug is incorporated into the bundle without a rate adjustment, facilities may have financial incentives to limit use of costlier new drugs

ARDX /Mott. needs to make a deal with CMS to get Xphozah covered for Medicare dialysis patients . Right now they aren't getting $ for these patients ...unless they are in their Assist program ...which may mean ARDX if giving Xphozah for almost free just to keep them on X .
So if ARDX does not make a deal with CMS , refuses to go into the TDAPA program as its currently designed ...they will have wasted millions of $ on this drug which never reaches roughly 60% of the dialysis patients that could use it .

CMS could just wait them out . Which appears their current strategy . ARDX / Mott eventual cave , start the existing TDAPA process ...and lose the income they would have received already if they had started TDAPA when scheduled.

Kiwi

Revenue will also send this higher. Q1 numbers in May will be important.

Mott keeps buying in the open market ...main reason I keep my small position .
Any deal with CMS will send this significantly higher .
A small select group of patients ...those that have serious constipation problems ...love Xphozah for serum pho control ...so there is a small well defined market of Medicare patients

Kiwi

Basically increases shares owned by 50% in one fell swoop.  Not much shame.  Lowering my target on this.  I am sort of thinking of this investment as partially a binary coupling with UNCY.  If UNCY is successful and steals sales from ARDX it will be like a hedge for me. 

Holy sh#t ...the RSU's these guys award themselves
http://archive.fast-edgar.com/20250227/AMZZC62CO2228ZBZ2M2O2ZZ2RG5AZ22IZ472/
These vest over 48 mths ...even at $5 a share ...do the math !!!!

At least the Chairman of the Board Mott is still buying in the open market

Kiwi

Hi RMB. I think it's up to their Chinese partner to get govt reimbursement lined up and the drug launched . ARDX will only receive royalty payments when /if that happens .
Pressing issue is Xphozah and Medicare patients / CMS stance .
Currently Medicare dialysis patients aren't covered so Co is providing an Assist program ...Dont know how well thats used or even if Co breakevens even on it .
CMS ( JFK jnr ? ) will probably play hard ball .
Why pay extra for Xphozah when the same drug in IBSRELA form is so much cheaper .
If they at least started the TDAPA process they would get full payment for at least 2 yrs ....maybe 2.5 yrs ...and then a decline in reimbursement for the following 3 yrs .
Right now ARDX gets nothing from the CMS / Medicare dialysis patients beyond their assist program ( which may actual cost them or be break even )
Meanwhile UNCY is on track for its June approval of OLC ...and they have already said they will start the TDAPA process as soon as possible.....and be the new serum pho binder available to Medicare dialysis patients .

Been spending more time on APP lately so visit me on that board if U like and I can explain whats going on there

Kiwi

Thanks.  Not seemingly doing much for the sp 

From X Approval in China

Frank
@justfactstruth
·
1h
$ARDX -CHINESE APPROVAL !!!!!
-On February 25, the official website of the National Medical Products Administration (NMPA) showed that Fosun Pharma's innovative drug Tenapanor (tenapanor hydrochloride tablets) has been approved for the control of hyperphosphatemia in adult
Show more
Followed by some accounts you follow

BioPharm_the_Magnificent
@crypto_biotech
$ARDX

### Milestones
- **Upfront Payment**: Ardelyx received an initial payment of $12 million upon entering the agreement in December 2017.

- **Developmental and Commercialization Milestones**: Ardelyx is eligible to receive up to $110 million in additional milestone payments tied to development and commercialization achievements. A notable example includes a $2 million milestone payment triggered by the acceptance of the New Drug A.

Further milestones would likely be linked to regulatory approval ( DONE ✅ ) and subsequent commercial successes, though specific amounts for each milestone beyond the $2 million are not publicly detailed in fixed increments.

### Royalties
- **Tiered Royalty Payments**: Ardelyx is entitled to receive royalties on net sales of tenapanor in China, ranging from the mid-teens to 20 percent. The exact royalty rate within this range depends on sales performance, with higher sales potentially yielding rates closer to 20%.

### Context of China Approval
Fosun Pharma NOW HAS exclusive rights to market and sell tenapanor in China, Hong Kong, and Macau for this indication, as well as other indications approved in the U.S. Successful approval and commercialization would unlock additional milestone payments and begin the royalty stream based on sales.

In summary, Ardelyx has already secured $14 million ($12 million upfront + $2 million NDA acceptance), with up to $96 million more possible in milestones (from the $110 million total) , plus tiered royalties from mid-teens to 20% on net sales following approval and market launch by Fosun Pharma.

Kiwi

Unicycive Therapeutics (UNCY) has published preclinical data in the ASN journal Kidney360 demonstrating synergistic benefits of combining oxylanthanum carbonate (OLC) with tenapanor for phosphate management.

The study showed that the combination therapy achieved a 41.3% reduction in urinary phosphate excretion compared to vehicle, significantly outperforming both individual treatments.

Key results showed tenapanor alone achieved a 12.5% reduction, while OLC monotherapy demonstrated a 17.7% reduction in phosphate excretion. The combination proved statistically significant (p=0.009 for 0.75% OLC + tenapanor).

This research is particularly relevant as approximately 75% of dialysis patients fail to meet serum phosphate targets set by KDIGO guidelines.
The study suggests OLC's low pill burden and palatable formulation, combined with tenapanor, could improve patient adherence and clinical outcomes in hyperphosphatemia treatment.

Kiwi

Post the highlights of the CC if U have time . Any details on a EU partnership / launch .
As U may have noticed in an earlier post I wrote ...I suspect some Medicare dialysis patients are trying to get scripts for IBS-C to use IBSRELA if XPHOZAH is unavailable..
The downside of this is that ARDX sells IBSRELA for far less per gm of Tenapanor compared to XPHOZAH ...So ARDX will be making less profit if CMS continues to play hard ball and cover XPHOZAH for Medicare , only if it's in the TDAPA dialysis bundle .

So I think CMS and Kennedy's FDA are going to have real issues paying what ARDX wants for XPHOZAH compared to what they pay for IBSRELA ...it's the same drug just different doses.
I also think the real world issues with diarrhea may be worse than reported in the clinical trials .

On a positive note Chairman of the board had been buying stock open market ...at least late 2024

Kiwi

Fairly decent earnings this morning but stock taking it on the chin in premarket.  Waiting for call to see if they say anything about current qtr or anything going forward. 

Yep. If you are a dialysis patient will poorly controlled serum pho ...just get your Nephrologist to prescribe you IBSRELA instead of Xphozah ...it's the same drug just packaged in different doses .
Covered I believe by Medicare at significantly lower cost ...just one 50 mg IBSRELA pill a day cut in half ....half with breakfast , half with dinner .
Kiwi

I think you're right which is why Ibsrela had a great Q4. Off label prescription

Well I suspect some dialysis patients are doing a work around using IBSRELA and a pill cutter


What is the daily dose of Tenapanor in Ibsrela vs Xphozah
Answer
The daily dose of tenapanor differs between Ibsrela and Xphozah:
For Ibsrela:
The recommended dosage is 50 mg twice daily, for a total daily dose of 100 mg14. This is typically taken immediately before breakfast and dinner7.
For Xphozah:
The recommended dosage is 30 mg twice daily, for a total daily dose of 60 mg25. This is also taken before the morning and evening meals5.
The difference in dosing is due to the distinct indications for each medication:
Ibsrela is used to treat irritable bowel syndrome with constipation (IBS-C) in adults1.
Xphozah is used to reduce serum phosphorus in adults with chronic kidney disease on dialysis5.
It's important to note that these medications should be taken as prescribed by a healthcare provider, and dosages may be adjusted based on individual patient needs and responses to treatment.

What is the cost of daily dose of each

The daily cost of Ibsrela and Xphozah differs based on their recommended dosages and pricing:
For Ibsrela:
The recommended dosage is 50 mg twice daily, totaling 100 mg per day5. A 60-tablet supply (30-day supply) costs around $1,9671. This translates to a daily cost of approximately $65.57.
For Xphozah:
The recommended dosage is 30 mg twice daily, totaling 60 mg per day6. A 60-tablet supply (30-day supply) costs around $3,3162. This results in a daily cost of approximately $110.53.
It's important to note that these prices are for cash-paying customers and may vary depending on factors such as insurance coverage, pharmacy location, and available discounts or coupons37. Patients with commercial insurance may be eligible for savings programs, potentially reducing their out-of-pocket costs4.


You can get 50 mg of Tenapanor ( IBSRELA ) for $33 per day , if you can get a script written for IBS-C
60 mg dose of Tenaapanor ( XPHOZAH ) will cost dialysis patients $110 per day.

So if you're a dialysis patient that hates the available pho binders ...get your Nephrologist to write you a script for IBSRELA ...for IBS-C ( which is a lot less expensive then a script for XPHOZAH ...and I think CMS / Medicare covers IBSRELA )

Be interesting if we see a big uptick in IBSRELA scripts this quarter .

Kiwi

No, no deal with CMS. They need to keep doing what they are doing.

OLC is probably going to run into the same politics as Xphozah. The FDA is going to find some BS delaying it for a year or two.

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