Ardelyx Inc (ARDX)

[Whalatane]

Opinion by Dew who I think is ex Harvard Med

Member Level
Re: Whalatane post# 252682
Thursday, July 25, 2024 10:04:04 PM
Post# of 252696
ARDX/UNCY—As noted earlier, the reversal of the "Chevron" doctrine by the US Supreme Court should give the plaintiffs in this case a decent chance of prevailing, IMO. Absent the reversal of Chevron, the lawsuit probably would not have been filed.

The reversal of the Chevron doctrine has received a lot of criticism from various parties, but here we have a case where two (arguably) deserving drug companies are clear beneficiaries.

So I think UNCY has the most upside should ARDX prevail against the CMS as Dew expects .
ARDX is spending the legal $ ...UNCY gets to ride along for free
Should ARDX prevail ....Both ARDX and UNCY will have niche markets since they are competing against generics ...however UNCY's OLC is more effective at lowering serum pho and is likely to be less expensive ...so any legal win is likely to be a huge plus for UNCY .
JMO
Kiwi

[Whalatane]

$ARDX Jeffries update report

Earnings August 1st

We Think Floor Value Should be Higher
-Currently, the Congress dynamic has been a key overhang as reflected by the stock baking in essentially minimal Xphozah revenue in 2025+. The pullback makes the H2 setup very intriguing on a (+) Congress catalyst, which should drive +50-100% upside and get the stock back to early 2024 levels when investors were overall more comfortable with Congress.

- Our analysis suggests Ibsrela should be worth more than current $5-6 / share and closer to $7 / share or +20-25% upside. Hitting or beating guidance will be key to how investors will value Ibsrela. Net-net, we think ARDX can achieve this.

-The H2 (Ibsrela) inflection will be driven by onboarding of 60 new reps. We had conservatively assumed hiring would finish Sep 2024 but our follow up analysis on jobs suggests probably July / Aug time-frame. This is earlier than anticipated and leaves more room for productivity ramp and makes hitting guidance easier.

-There also may be some capture rate dynamics that investors may not appreciate. We traditionally use a 90-95% capture rate for IBS scripts, which was why we (underestimated 1Q revs). It's possible specialty pharmacies may have changed how they report Ibsrela scripts and/or IMS reporting methodologies though it's unclear to us at this time if that dynamic continues in Q2 and the rest of 2024. But if the capture rate indeed has found a new 'steady state", then we could argue Ibsrela is doing better than what investors are thinking and there's a decent probability Ibsrela could beat the high end of 2Q24 guidance and mgmt could raise guidance later this year.

Copy from X
Kiwi

[Whalatane]

DaVita Inc. has agreed to pay more than $34 million to settle allegations brought by a former employee that it paid kickbacks to competitors and physicians in exchange for directing business to its patient care and pharmacy businesses.

Since DaVita ...a private dialysis provider is so profit driven ...its safe to assume they won't be prescribing much Xphazoh if X is in the dialysis bundle .
Dialysis provider get to keep the difference between what Medicare pays for dialysis and what dialysis costs them per patient .
So the incentive is to go cheap as long as patient quality levels don't decline .

Theres no incentive to IMPROVE patient quality level....ie by using pho binders that patients might tolerate better

Kiwi

[Whalatane]

Minority groups that want Oral pho binders ( Xphazoh ) to remain outside of the dialysis bundle

The National Minority Quality Forum, a health care research, education and advocacy organization, has joined a lawsuit against CMS to prevent the inclusion of oral phosphate-lowering therapies in the ESRD bundled payment.
The American Association of Kidney Patients (AAKP) is also part of this lawsuit. While not exclusively a minority group, AAKP advocates for all kidney patients, including minority populations who are disproportionately affected by kidney disease.
The Sickle Cell Disease Association of America supports keeping phosphate-lowering drugs out of the ESRD bundle. They note that 1 in 3 adults living with Sickle Cell Disease has chronic kidney disease, and keeping these drugs out of the bundle allows doctors and patients more control over their care regimen.
The National Consumers League, which advocates for patient-centered health care, expresses concern that changes in Medicare coverage will cause kidney patients to lose access to quality care and innovative treatments. This is likely to disproportionately affect minority patients.
Dr. Frita McRae Fisher, a nephrologist, argues that including phosphate-lowering therapies in the bundle would disproportionately affect Black patients, who make up more than 35% of dialysis patients but only 13.2% of the U.S. population.

Kiwi

[Whalatane]

If the Kidney Patient Act pass's it benefits the dialysis patients , the companies that make Oral pho binders ( ARDX and UNCY ) and means less stress on the dialysis providers since they don't have to manage securing , storing , dispensing the Oral pho binders.

Politically ... theres a hint of racism here since the majority on dialysis are people of color on Medicare . If Oral pho binders go into the bundle, these patients are likely to be pushed towards the available cheaper generics since the dialysis providers get to keep what ever they save .....between what the govt pays them per dialysis and what they spend per dialysis .
The private dialysis providers financial incentive is to not prescribe the new Oral pho binders ....even tho their patients may do better on them .

Minority groups ( as in black and latino ) are advocating for these new oral pho binders to remain out of the dialysis bundle for at least 2 yrs so that MD's at the private dialysis providers will be free to prescribe as necessary

When freely prescribed , Medicare is billed directly .
Xphazoh is around $3,000 a month .
Medicare will pay about 75 % of that ie $2,250 ...a month
The patients co pay is $750 a month which most of these patients can not afford ...so ARDX will offer coupons so the patient pays little
ARDX makes their $ from the Medicare payment ( $2,250 ) .

Medicare will feel they are being overcharged if X stays outside the bundle ...and ARDX maintains X won't be prescribed if its inside the bundle .
Is there potential for a compromise ...ala Repatha ( AMGN ) ...time will tell

Kiwi

[Cosa]

What's the political motive or who does this benefit by the act passing.

[Whalatane]

My response to Dew on the biotech values board
Dew. Re the Kidney Patient Act , dialysis bundle and their impact on ARDX and UNCY .
Dialysis providers and dialysis patient groups are against CMS's endeavor to include oral phosphate binders in the dialysis bundle starting Jan 2025.
Dialysis providers are against this move primarily because phosphate binders are not part of the dialysis process and they feel storing , managing and dispensing of these drugs will be cumbersome , expensive and they aren't prepared for it .
Dialysis patient groups are against it as including the new oral pho drugs will limit their use and stifle further innovation .

Keep in mind that dialysis providers get to keep the difference between what the govt pays per dialysis and what it costs them to provide each service .
For private dialysis co's it's a huge incentive to use the cheapest pho binders the patient can tolerate ....if oral pho binders are in the dialysis bundle .

CMS monitors to see if changes result in lower patient care . Theres not the same effort applied to seeing if patient care has improved.

I have been buying ARDX and UNCY after their recent drops .
These are purely speculative plays on the Kidney Patient Act passing and the Oral pho binders being kept out of the dialysis bundle for at least another 2 -3 yrs .
Info only ...NOT investment advice
UNCY is likely to disappear if Oral pho drugs are included in the dialysis bundle and ARDX will live on a smaller version of itself based on their Ibresla sales
JMO
Kiwi

[Whalatane]

The dialysis bundle explained and its relevance to ARDX and UNCY

The dialysis bundle in the United States is a comprehensive payment system implemented by Medicare for end-stage renal disease (ESRD) treatment. Here's an explanation of the key aspects:
Purpose and Implementation:
The dialysis bundle, officially known as the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), was implemented on January 1, 2011. Its purpose is to provide a single, bundled payment to dialysis facilities for renal dialysis services provided to Medicare beneficiaries.
What's Included in the Bundle:
The bundled per-treatment payment covers:
Dialysis treatment
Drugs and injectable medications
Laboratory services
Supplies
Capital-related costs
Equipment and supplies used for home dialysis
Oral drugs with injectable equivalents
Payment Structure:
The payment is made on a per-treatment basis and is adjusted for patient-level and facility-level factors. It includes provisions for:
A base rate
Adjustments for patient demographics and comorbidities
Quality incentives through the Medicare Quality Improvement Program (QIP)
Oral-Only Drugs:
Currently, oral-only drugs (those without injectable equivalents) are not included in the bundle. However, CMS plans to incorporate these, specifically phosphate binders, into the bundled payment starting January 1, 2025.
Innovative Treatments:
The system includes provisions for new treatments:
Transitional Drug Add-on Payment Adjustment (TDAPA) for new renal dialysis drugs and biologicals
Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
Impact on Clinical Care:
The bundled payment system has led to changes in clinical algorithms and quality improvement activities. For example, Fresenius Kidney Care reported optimizing the use of erythropoiesis-stimulating agents (ESAs) and vitamin D treatments while maintaining or improving quality outcomes.
Quality Metrics:
The bundle is tied to quality metrics through the QIP, which examines factors such as dialysis adequacy and management of complications like hypercalcemia.
Drug Designation Process:
CMS uses a drug designation process to determine how new renal dialysis drugs and biological products are incorporated into the bundled payment.
The dialysis bundle aims to incentivize efficient care delivery while maintaining or improving quality outcomes for ESRD patients. It has led to changes in clinical practices and resource allocation within dialysis facilities, with ongoing adjustments to incorporate new treatments and medications into the payment system.

Note high lighted area .
If included in the bundle , price caps would limit any use of OLC ( UNCY ) or Xphazoh (ARDX )

Outside the bundle the MD can get Medicare to cover 75% of the cost and the Co can issue coupons to reduce the copay to the patient

Kiwi

[Whalatane]

Thx for that link . Passage of the Kidney patient act likely to be the major catalyst near term


Kwi

[skitahoe]

New S-A article on ARDX:

https://seekingalpha.com/article/4703873-ardelyx-increased-focus-on-ibsrela-due-to-xphozahs-uncertain-outlook?mailingid=36050918&messageid=m$ARDX

I believe the author has a good feel for what's happening, and eventually success will be coming, perhaps not as quickly as some of the investors thought, but it will happen in time.

Gary

[Nebuchadnezzar]

ARDX wild ride from $8 to sub $1 back to $8

now $5

[Whalatane]

From X $ARDX Raymond James Note to clients

W e remain STRONG BUY RATED on ARDX and our reducing price target $1 to $15 after today’s announcement they would not be applying to include Xphozah in CMS’ ESRD- PPS TDAPA

What does this mean- Our assumption is that Medicare patients will lose Xphozah coverage indefinitely starting January 2025 unless a development such as the signing law of the Kidney Patient act occurs in the interim -(this is reflected in our model)

While there is much debate amongst investors regarding weather, skipping out on the TDAPA . 1) avoid faster erosion of commercial access to Xphozah (ARDX’s take), or 2) needlessly forfeit potentially two years of Medicare patient revenues (Street’s prevailing take), one thing is clear: there’s already no path to Medicare patient coverage for Xphozah after 2027 outside of legislation or some similar development.

We also point out that ARDX dropped 30% to $5.28 in Tuesday session, which is at a deep discount to our $15 PT and equivalent to ~2X 5-year (2029) consensus Ibsrela net sales (VA, n=3), providing an opportunity to buy the weakness, particularly for investors who think Ibsrela sales could eventually approach or even achieve blockbuster peak sales (we use $748M US Peak sales in our model)

Model Impact - The only changes to our model are inclusion of 50% Kidney Patient Act PoS adjustment to 2025 and 2026 Medicare sales (estimated at 63% of the total US HP market; ARDX estimates to be less conservative at 55%) and removing Medicare sales from 2027 and 2028 (they are already removed from 2029 to 2035). As a result of these changes our price target drops $1 to $15.

Kiwi

[Whalatane]

Cosa ...along the lines of your argument

Kidney Care Partners Applauds Senate Introduction of Bipartisan Kidney PATIENT Act
June 12, 2024

Delay Will Ensure Continued Access to Innovative Treatments for Individuals Living with Kidney Failure

WASHINGTON – Kidney Care Partners (KCP) – the nation’s leading kidney care multi-stakeholder coalition representing patient advocates, physician organizations, health professional groups, dialysis providers, researchers, and manufacturers – today commends Sens. Ben Ray Luján (D-NM) and Marsha Blackburn (R-TN) for introducing the Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments (PATIENT) Act (S. 4510), which would delay for two years the inclusion of oral phosphate-binding medication into the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). The Ways & Means and Energy & Commerce Committees have already passed a similar measure in the U.S. House of Representatives.

Oral phosphate-binding medications are necessary to treat hyperphosphatemia, a condition that occurs in nearly all individuals who receive dialysis treatments. If not treated, hyperphosphatemia can increase mortality, vascular calcification, and cardiovascular events

. Currently, patients can access these drugs at their local pharmacy, but as of January 1, 2025, a new policy change from the Centers for Medicare & Medicaid Services (CMS) will instead require dialysis providers to distribute these medications.
KCP is concerned this policy may negatively impact patient access to care, as many dialysis providers lack sufficient infrastructure needed to dispense and administer these drugs.

“We thank Senators Luján and Blackburn for introducing this bill to ensure continued patient access to these vital medications. Without action, CMS’ policy creates yet another challenge for the kidney community to face. Already limited access to innovative treatments and inadequate reimbursement levels are impacting kidney care,” said Colin Roskey, Executive Director of KCP. “To maintain quality, accessible treatment for individuals living with end-stage renal disease, we urge lawmakers to advance this bill without delay.”

I wonder why CMS wants the dialysis providers to manage / store / dispense these oral meds .
Dialysis units usually just want to deal with what they need for the dialysis process ......all additional drugs the patient outside of their point of care ( ie while in the dialysis clinic ) takes is thru the pharmacy

Kiwi

[Whalatane]

Here its modified

Washington D.C. — U.S. Reps. Terri Sewell (D-AL) and Carol Miller (R-WV) celebrated as their Bipartisan Kidney Patient Access to Technologically Innovative and Essential Nephrological Treatments (PATIENT) Act passed 41-1 in the House Ways and Means Committee. Reps. Sewell and Miller introduced the legislation to provide access to critical care and affordable oral medicines for chronic kidney disease patients.

“It is critically important that we protect access to oral-only therapies for patients with End-Stage Renal Disease,” said Rep. Sewell. “I am absolutely thrilled that the Ways and Means Committee has passed our Kidney PATIENT Act with strong bipartisan support. I thank Congresswoman Miller for her partnership and look forward to continuing to push this bill across the finish line.”

“I was thrilled to see the Kidney PATIENT Act pass nearly unanimously out of the Ways and Means Committee and be one step closer to becoming law,” said Rep. Miller. “This bill will provide patients with access to oral-only kidney disease therapies through their Medicare Part D benefit until 2027. Bipartisan support of the Kidney PATIENT Act from the Ways and Means Committee shows how important it is to take care of ESRD patients across the country. I look forward to the bill continuing to move forward in the House of Representatives.”

So now down to 2 yrs plus the 2 yrs in TDAPA ...so 4 yrs before the Bundle kicks in
Kiwi

[Whalatane]

The Kidney PATIENT Act (H.R. 5074) is 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.

Till 2033 !!!!...no wonder they want this to pass
Kiwi

[Whalatane]

How do dialysis providers save money in the dialysis bundle

Dialysis providers employ several strategies to save money within the bundled payment system for dialysis services:
Reducing use of expensive medications:. my emphasis ...why ARDX wants to delay the TDAPA process and get the Kidney Care act passed .

Providers may decrease the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D, substituting them with less expensive alternatives when possible.
Optimizing drug dosing: Facilities carefully manage medication dosing to avoid waste and
unnecessary use while still meeting clinical needs.

Substituting with generics: Where available, providers may switch to generic versions of medications to reduce costs.

Limiting ancillary services: Non-essential services or those not directly related to dialysis may be reduced or eliminated from the bundle.
Shortening treatment times: Some facilities may attempt to reduce dialysis session durations to save on operational costs, though this can be controversial due to potential impacts on quality of care.
Reducing staffing: Facilities may try to operate with minimal staffing levels to cut labor costs.
Shifting care settings: When possible, providers may move certain services to outpatient or home settings which can be less expensive than in-center care.
Improving efficiency: Streamlining processes and optimizing resource utilization can help reduce overall costs.
Careful patient selection: Some facilities may try to select less complex patients who require fewer resources, though this practice is discouraged.
Volume management: Providers may aim to treat a higher volume of patients to spread fixed costs over more treatments.
While these cost-saving measures can improve efficiency, there are concerns that excessive focus on cost reduction could negatively impact quality of care. To counteract this, quality assessment programs and incentive payments have been implemented in some health systems to ensure that cost savings do not come at the expense of patient outcomes.
It's important to note that while these strategies can save money for providers, they must be balanced against maintaining high-quality care and meeting regulatory requirements. Policymakers and healthcare systems continue to work on refining payment models to align financial incentives with optimal patient care.
What are the main cost-saving strategies dialysis providers use within the bundle system

Sources



dialysispatients.org favicon
ncbi.nlm.nih favicon
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Answer
Based on the search results, dialysis providers employ several key strategies to save costs within the bundled payment system:
Reducing use of expensive medications: Providers may decrease the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D, substituting them with less expensive alternatives when possible.
Optimizing drug dosing: Facilities carefully manage medication dosing to avoid waste and unnecessary use while still meeting clinical needs.
Shifting care settings: When possible, providers may move certain services to outpatient or home settings which can be less expensive than in-center care.
Shortening treatment times: Some facilities may attempt to reduce dialysis session durations to save on operational costs, though this can be controversial due to potential impacts on quality of care.
Limiting ancillary services: Non-essential services or those not directly related to dialysis may be reduced or eliminated from the bundle.
Implementing fail-first protocols: Some centers require patients to try less expensive treatments first before accessing more costly options, like requiring oral generic drugs before intravenous calcimimetics.
Careful patient selection: Some facilities may try to select less complex patients who require fewer resources, though this practice is discouraged and partially addressed through risk adjustment in the payment system.
Shifting costs outside the bundle: Providers may attempt to move certain services or prescriptions to non-dialysis visits to avoid incurring costs within the bundled payment.
It's important to note that while these strategies can save money for providers, there are concerns that excessive focus on cost reduction could negatively impact quality of care. To counteract this, quality assessment programs and incentive payments have been implemented in some health systems to ensure that cost savings do not come at the expense of patient outcomes.
What are the challenges dialysis providers face when implementing the bundle system

Sources



dialysispatients.org favicon
ncbi.nlm.nih favicon
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Answer
Dialysis providers face several key challenges when implementing the bundled payment system:
Balancing cost reduction with quality care: Providers must find ways to reduce costs while still maintaining or improving patient outcomes and quality of care. This requires careful management of resources and treatment protocols.
Medication management: The bundle includes previously separately billable medications like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D. Providers need to optimize drug dosing and usage to control costs without compromising patient health.
Adapting to fixed payments: With a set reimbursement rate, providers must carefully manage all aspects of care within the bundle, including medications, laboratory tests, and other dialysis-related services.
Risk of patient selection: While partially addressed through risk adjustment, there's still potential for providers to favor healthier, less complex patients who require fewer resources.
Limited flexibility for complex cases: The bundle may not adequately account for patients with multiple comorbidities or those requiring more intensive care, potentially penalizing providers who treat more complex cases.
Rapid adaptation to treatment changes: As new technologies or treatment methods emerge, providers must quickly adjust their practices within the constraints of the bundle.
Managing outliers: Providers need to develop strategies to address patients who fall outside typical treatment patterns or require additional resources.
Financial risk management: Smaller providers or independent facilities may face challenges in managing financial risks due to their limited ability to pool risks compared to larger organizations.
Aligning incentives with value-based care: While the bundle aims to control costs, providers must also focus on improving overall patient outcomes and moving towards value-based care models.
Potential for undertreatment: There's a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly treatments.
These challenges require dialysis providers to carefully balance financial considerations with patient care, optimize resource utilization, and continually refine their clinical and operational practices to succeed within the bundled payment system.
What are the biggest obstacles in managing medication costs under the bundle system

Sources



ncbi.nlm.nih favicon
fmcna.com favicon
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Answer
Based on the search results, the biggest obstacles dialysis providers face in managing medication costs under the bundle system include:
Balancing cost reduction with quality care: Providers must find ways to reduce medication costs while still maintaining or improving patient outcomes and quality of care.
Optimizing drug dosing and usage: With medications like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D now included in the bundle, providers need to carefully manage dosing to control costs without compromising patient health.
Adapting to fixed payments: The bundled system provides a set reimbursement rate, requiring providers to carefully manage all aspects of care, including medications, within the bundle constraints.
Managing complex cases: The bundle may not adequately account for patients with multiple comorbidities or those requiring more intensive care and medication regimens.
Rapid adaptation to treatment changes: As new medications or treatment methods emerge, providers must quickly adjust their practices within the constraints of the bundle.
Potential for undertreatment: There's a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly medications.
Shifting costs outside the bundle: Some providers may attempt to move certain services or prescriptions to non-dialysis visits to avoid incurring costs within the bundled payment, which can lead to fragmented care.
Managing multiple pharmacy sources: With the inclusion of dialysis-specific oral medications in the bundle, patients may receive prescriptions from multiple pharmacies, complicating medication management.
Limited flexibility: The bundle system may restrict providers' ability to use more expensive, potentially higher-quality treatment options or newer medications.
Implementing cost-effective medication management services: Providers need to develop efficient systems for medication reconciliation and therapy management within the constraints of the bundle, which can be challenging and resource-intensive.
These obstacles require dialysis providers to carefully balance financial considerations with patient care, optimize resource utilization, and continually refine their clinical and operational practices to succeed within the bundled payment system.
How does the bundle system affect the availability of medications for dialysis patients

Sources



gao.gov favicon
ncbi.nlm.nih favicon
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Answer
The bundled payment system for dialysis care has significantly impacted the availability and utilization of medications for dialysis patients in several ways:
Reduced use of expensive medications: Providers have decreased the use of costly drugs like erythropoiesis-stimulating agents (ESAs) and intravenous vitamin D to control costs, while still maintaining or improving patient outcomes.
Optimization of drug dosing: Facilities carefully manage medication dosing to avoid waste and unnecessary use while meeting clinical needs.
Substitution with generics: Where available, providers may switch to generic versions of medications to reduce costs.
Potential undertreatment: There is a risk that the fixed payment structure could incentivize providers to undertreat patients or limit access to necessary but costly treatments.
Challenges with new medications: The bundle system may restrict providers' ability to use more expensive, potentially higher-quality treatment options or newer medications. For example, the anti-itching drug difelikefalin faced uncertainty about long-term funding, discouraging nephrologists from prescribing it, resulting in fewer than 1% of dialysis patients receiving it.
Expansion of home dialysis: Following the introduction of bundling, there was a slight uptick in patients starting renal-replacement therapy on home dialysis, especially peritoneal dialysis (PD), as providers sought more cost-effective options.
Increased focus on value-based care: The bundle has encouraged dialysis providers to focus on how they can achieve the best patient outcomes while restraining costs, leading to a greater emphasis on value-based care models.
In summary, while the bundle system aims to control costs, it has also created challenges in ensuring dialysis patients have access to necessary medications, particularly newer or more expensive treatments. Providers must carefully balance cost-saving measures with maintaining high-quality care and meeting patients' needs.

AI generated
Kiwi

[Whalatane]

How does the TDAPA process limit use of a new drug

The Transitional Drug Add-on Payment Adjustment (TDAPA) process does not directly limit the use of new drugs, but it does impact how new drugs are paid for under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). Here are the key points about how TDAPA works:
TDAPA provides a temporary payment adjustment for certain new renal dialysis drugs and biological products for a limited time period.
For drugs that fall into an existing ESRD PPS functional category, TDAPA is paid for 2 years.
For drugs that do not fall into an existing functional category, TDAPA is paid for at least 2 years until sufficient claims data is available for rate setting analysis.

During the TDAPA period, the new drug is paid at 100% of its Average Sales Price (ASP). If ASP is unavailable, payment is based on Wholesale Acquisition Cost (WAC) or manufacturer's invoice.

After the TDAPA period ends, the drug is incorporated into the ESRD PPS bundled payment.
For drugs in existing functional categories, the bundled payment rate is not automatically adjusted after TDAPA ends to reflect the new drug's costs.
TDAPA is not available for certain generic drugs and drugs approved under specific FDA application types.

While TDAPA does not directly restrict drug use, the payment structure may indirectly impact utilization:

The temporary nature of the add-on payment could influence facilities' decisions about adopting new, potentially more expensive therapies.

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.....my emphasis

The exclusion of certain drug types from TDAPA eligibility may affect their uptake in ESRD care.

Overall, TDAPA aims to balance supporting innovation and access to new therapies with maintaining the bundled payment structure of the ESRD PPS.

The time-limited nature of the adjustment and the eventual incorporation into the bundle without guaranteed rate increases could indirectly influence drug utilization patterns.

AI generated from Gov and legal sources .

Once a drug is in the dialysis bundle theres pressure on prescribers to use less expensive generic drugs whenever possible as any savings is kept by the dialysis provider .
If the Kidney Care act is passed and Xphazoh stays out of the bundle for 2 yrs ...then another 2 yrs from the Tdapa process ...they have 4 yrs without MD's facing pressure to prescribe less expensive drugs ...just my take
Kiwi

[Cosa]

If they thought that was going to continue they wouldn't have done what they did today

That's incorrect. It clearly says that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH. Restrictions mean limiting how and when it is to be used.

[Whalatane]

Well eventual sales worldwide ...or at least US, EU and Japan ...if the Kidney Care Act passes and the EU countries agree to reimburse generously .
What's the status in the EU ????

From quick search ...no deal / sales in the EU ...maybe they looking for a partner
Kiwi

[Whalatane]

Dialysis bundles are fixed payments from the Govt to the Health providers doing the dialysis .
The way its set up is that any money saved ...is kept by the dialysis provider .
This incentives the private dialysis Co's US Renal , DaVita to push generics for pho lowering even if the MD in the dialysis center thought Xphazoh would be better for the patient .
Thats the essence of why ARDX wants the Kidney Care Act passed ...that keeps them out of the dialysis bundle for 2 yrs .

Re sales last qt smashing expectations . Don't read to much into that . If they thought that was going to continue they wouldn't have done what they did today
JMO
Kiwi

[Johnstonj27]

Xphazoh was supposed to be and 1 billion dollar per year rev drug.

[Cosa]

In my opinion management read through the policy and realized it is not best for the company. And at the rate Xphozah is being prescribed, I believe they are correct. The sales last quarter smashed through expectations.

Ardelyx said its analysis of the CMS policy to include oral-only medicines in the PPS and the calendar year 2025 ESRD PPS Proposed Rule released on June 27, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients.
From Erica Kollman article.

[Whalatane]

I just listened to the CC .
Buying ARDX here is a huge bet on the Kidney Care Act being passed by the Senate . It's apparently passed by the Congress.
The Kidney Care act allows new oral dialysis drugs to remain outside the dialysis bundle for at least 2 yrs .
The problem with the dialysis bundle is that it forces prescribers to shun expensive drugs if cheap generic are available even if the generics are poorly tolerated.
The Tdapa process thats due to start at EOY would mean ARDX would have limited access due to being an expensive drug in the dialysis bundle

I thought their action was more about avoiding the coupon restriction but its actually about being able to have free access to market for 2 yrs before dialysis bundle restrictions

So buying here is a bet on the Kidney Care Act passing in the Senate and becoming law.

Kiwi

[Cosa]

I shot those numbers out of my A55 lol. But you get the picture. Even if its flat at $150M for year 2025, to trade at $300M market cap is highly unlikely. I think from here it will see 50 - 100% gain within a few months. Good luck

[Whalatane]

Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

Doubt you will see another $150m rev from Xphazoh to get to your $300m total rev by next yr ( ie by EOY )

Co will still have $ 170 m cash on hand .
It's not going down 80% from here based on COH and IBSRELA rev .

How much does Xphazoh cost if you can use their discount coupon ??? Anyone know .....cos thats the reason IMHO not to go the Medicare route

https://xphozah-hcp.com/dosing/

Call ArdelyxAssist
877-527-3927 Option 2

Kiwi

[Cosa]

So you're waiting for the market cap to go $300M, which is basically what their revenue will probably be next year? That doesn't make sense to me. I don't think this will go down another 80% from here. That would put the share price at pre Xphozah approval in 2022. I guess we will agree to disagree here.

[ErnieBilco]

Only way I buy at this point is if I see my original buy price appear again, with the lawyers circling ARDX it could realistically go even lower than the $1.13 I bought in at years ago, just so damn glad a friend of mine talked me into letting go of my $30 dream and sold out in the mid $7s.

I do still manage a very small position in my brother's account but the other 6 accounts are empty.

[ErnieBilco]

Piper Sandler has the most realistic price target of $7 while the others must be gooberment economists with the fake outperform targets.

[Johnstonj27]

Used to hold a big position in this and Raab plays games with retail shareholders always has. Multiple times now have seen this tank on shareholders like this with all the PT's getting dropped like he works hand and hand with the analyst and hedges. Watch you will get news silence all the way to 10q.

[ErnieBilco]

Somebody told something to someone to create the massive drop of 31% on quadruple volume -

Not sure it's even close to bottom yet - What happens when the rest of you shareholders find out what they whispered to the buddies?

[Cosa]

Added some today. I'm pretty sure the numbers Q2 numbers for the next ER will turn this right around.

[enthalpy]

So pissed. He should have played ball.

[Johnstonj27]

M. Raab should be investigated for providing inside information I would suspect it. Seems like too many times the shareholders have just gotten completely bent over by him.

[Whalatane]

Their pricing for X was always F'd up IMHO .
My wife rounds dialysis clinics and is authorized to prescribe and she said ...I can prescribe X but most of my patients are Medicare / Medicaid and none of them are willing to pay the monthly copay ...which I estimated to be at least $700 - $900 a mth .

My guess is the Co hopes to get the monthly copay down to around $400 a mth . It's probably around $600 a month using the current coupon for non Medicare patients .
More sales but less profit per sale ...helped by passage of legislation before Congress .

Wether patients are willing to pay $400 a mth rather then trying to tolerate current generic binders ( low cost ) ...remains to be seen

But Co must be trading almost at the IBSRELA value alone at these levels. IBSRELA scripts are strong and copay more reasonable for a population that is usually younger and working age

Kiwi

[ErnieBilco]

A 27% drop is a huge drop IMO, If I had any faith in the company it would be a reasonable place to buy.

I'm just not a buyer up here and it wouldn't be the first time I let my gut cost me gains, there is just something about this group that gives me the willies.

[Whalatane]

I'm buying down 27%
I had sold ARDX on approval and then the stock continued to ramp ...so have been out of it for some time .
I didn't like how they priced Xphazoh for dialysis patients ...they are charging a premium for the same drug used by IBSC patients ( Tenanapour )
Currently the monthly retail price is close to $3,000 a month for dialysis patients .
As a tier 5 formulary drug the co pay can be as high as a third of the retail price for Medicare patients who can't use the Co's coupon.

So the question is ..... if Xphazoh is not covered by Medicare ......will these patients be able to use the X coupon and effectively be able to buy X at a lower price.
Medicare patients can't use Co's coupons .

The legislation to keep X out of the dialysis bundle has a good chance of passing ....so should make it easier to prescribe .

The other question is if more patients can now use the X coupon ...will ARDX make any $ as the coupon has to be a large enough discount to reduce copay lower then what Medicare patients would be paying .

Small spec buy on my part
Info only. NOT investment advice
Kiwi

[ErnieBilco]

Will be interesting to see if the insiders accelerate their selling beyond the obscene amounts they have been selling weekly and monthly.

Looks like the party may be coming to an end due to greedy management.

[Johnstonj27]

Watching this what an A hole M. Raab is.

[Whalatane]

Well it looks as tho ARDX is making a huge bet on the pending legislation to keep Xphazoh out of the dialysis bundle

We believe that the proposed bipartisan legislation extending the exclusion of oral-only medications from the Medicare ESRD PPS is the best option to ensure continued patient access, and we call on Congress to pass the bill.

As I've posted previously ....about 80% of dialysis patients are either Medicare or Medicaid and can't use the coupon the Co is currently offering . So these patients have about a $700-$800 monthly copay which few are willing to pay

I'm assuming that if this legislation pass's then all could use the coupon ...correct if necessary
Kiwi

[Whalatane]

Well it will certainly help the stock ( and sales of Xphazoh ) if X is kept out of the dialysis bundle which should give prescribers more freedom to prescribe .
House passed the new law ( to keep new pho lowering meds out of the bundle ) and I guess market now expects it to pass in the Senate
Kiwi

[enthalpy]

It was a 40% fibonacci pullback and imo a potential buyout or just the start of the 2nd wave up over 6 months. I'm expecting 12 by end of Q3.

[ErnieBilco]

Hopefully it is just the beginning or a huge rebound - time will tell. Also did some adds on RNLX on its smackdown.

ARDX made a big move on it fluffish news about educating medicos about irritable bowel symptom. I really don't where their expertise lies to qualify them for such a project but what the hell it got the stock to move and that's what the insiders are all about, moving the stock to sell more at a higher pps for themselves. JMHO

[Whalatane]

Well UNCY worked for U today
Good luck
Kiwi

[ErnieBilco]

I completely understand your position, I'm just saying that even with the destruction of the share price, I personally like the risk/reward at a 40 cent pps vs the ARDX at $6+. All I see ARDX doing is enriching themselves with freeflowing shares almost monthly. I'm just a hillbiilie so that greed upsets me and sparked my total exit from ARDX.

I understand you have a deeper understanding of the medical things I just buy stocks I think I can make money on.

[Whalatane]

Ernie ...they had time to get the extra enrolled patients evaluated . The risk is that so many were dropping out therefore they needed to enroll more .
The danger is ...if enrollees are dropping out so much ...good luck getting OLC widely accepted .
I still hold some shares and will follow but right now I'm not very positive on the Co
Kiwi

[ErnieBilco]

I did not listen to the CC, I usually don't so that is not unusual. Right now I can get so much more bang for my $$.
I never overload any position so I'm comfortable waiting to see how it turns out.
The 25% shortage of evaluated patients versus enrolled, but as I remember they increased the enrollment towards the end of the trial so they may not have had time to get the extra enrollees evaluated.

[Whalatane]

Good luck. Were you able to listen to UNCY's CC . It kept cutting out for me .
Did they ever explain why 106 were enrolled but only 71 evaluated ... to lose roughly 25% of enrollment in such a short time needs some convincing explaining
Kiwi

[Whalatane]

I sold most of my UNCY immediately on the results . Obviously markets wasn't buying what the Ceo was trying to sell during the CC.
Re crowded binder market ...it's mainly generic Sevelmar ( Renvela ? ) I think and some on Fosrenol .
80% of dialysis patients are on Medicare / Medicaid and can't use the coupon and most won't pay the $700-$800 monthly copay ....unless Co comes up with a different plan for them
20% of dialysis patients can use the coupon ....so theres your low hanging fruit.

Kiwi

[enthalpy]

That explains the drop then.

[ErnieBilco]

UNCY They just doubled the AS 7 days ago from 200mm to 400mm

I'm buying the drops