Ardelyx Inc (ARDX) Quote

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


Kwi

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

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

now $5

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

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

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

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

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
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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



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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

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

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.

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

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

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

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.

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

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

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

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.

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.

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

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.

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?

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

So pissed. He should have played ball.

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.

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

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.

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

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.

Watching this what an A hole M. Raab is.

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

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

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.

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

Well UNCY worked for U today
Good luck
Kiwi

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.

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

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.

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

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

That explains the drop then.

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

I'm buying the drops

UNCY will be reverse splitting imo. Good luck on that with a crowded binders market.

Oh cheer up . UNCY's trial ended with a whimper not a bang ( enrolled 106 but only had 71 to evaluate ....raised some questions as to market place viability ) .
So OLC as a competitor now in doubt.
Legislation was passed by the house , on its way to the Senate that will keep Xphazoh out of the dialysis bundle ( thats a good thing ) .
ARDX is aggressively marketing X on websites visited by Nephrologists so even if the Medicare / Medicaid dialysis patients can't use the coupon ...at least about 20 % of dialysis patients that aren't on a Govt plan, can .

Ibresla scripts still strong

Kiwi

Looks like the decline is going to accelerate from here. Unless they can put out some worthless fluff - anymore employee RSUs and it could see $4 - $3 in short order.

More CEO selling - this week 237K shares - these people all have about a qtr million shares left to dump but don't worry they will grant themselves as much as they may want - NEVER SEEN ANYTHING LIKE THIS GANG.

OMG they continue to make the whole company about giving away stock to insiders and employees instead of drugs to patients that need them. They have turned ARDX into their own personal ATM machine.

Thx for the DD
Kiwi

This value they claim is based on fairytale assumptions and really mean nothing.

Again these preferred warrants of many different letters A,B,C are milestone based not share price based - this may be how they were able to overvalue them best on possible outcomes, if the milestones don't happen the warrants are worthless unless they sneak back in and come up with a different gimmick to allow the handing out of no cost Preferred classes of stock. This is not a normal way to do warrants but I guess they had to spike the punchbowl to get the hedgies to drink the koolaid.

Here is what I see, nowhere does it mention an exercise price on any of the warrants they handed out to the hedgies. It is really based on milestones rather than share price but what I believe to be free flowing warrants that do not cost the holders a penny to exercise rather they will probably automatically convert at time of each milestone for each different class of warrant. It's really a screw the shareholders way of presenting hidden warrants to the monied investors and insiders is my guess.

, each share of Series A-1 Preferred Stock is, subject to the Stockholder Approval (as defined below), convertible
into a unit (“Unit”) consisting of (i) shares of common stock, par value $0.001 per share, of the Company (the “Common Stock”) and, if applicable, shares of Series A-2 Convertible Preferred Stock, par value $0.001 per share, of the Company (the “Series A-2 Preferred Stock”), in lieu of Common Stock, (ii) a tranche A warrant to acquire shares of Series A-3 Convertible Preferred Stock (the “Tranche A Warrant”), (iii) a tranche B warrant to acquire shares of Series A-4 Convertible Preferred Stock (the “Tranche B Warrant”), and (iv) a tranche C warrant to acquire shares of Series A-5 Convertible Preferred Stock (the “Tranche C Warrant”, together with the Tranche A Warrant and the Tranche B Warrant, the “Warrants”). The shares of Series A-3 Convertible Preferred Stock, Series A-4 Convertible Preferred Stock and Series A-5 Convertible Preferred Stock issuable upon exercise of the Warrants collectively are referred to herein as the “Preferred Warrant Shares”. The Tranche A warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of FDA approval for Renazorb, the Tranche B warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of Transitional Drug Add-On Payment Adjustment (“TDAPA”) approval for Renazorb, and the Tranche C Warrant for an aggregate exercise price of approximately $50 million are exercisable until 21 days following four quarters of commercial sales of Renazorb following receipt of TDAPA approval. Subject to the terms and limitations contained in the Certificate of Designation, the Series A-1 Preferred Stock issued in the Offering will not become convertible until the Company’s stockholders approve the issuance of the Units upon conversion of the Series A-1 Preferred Stock and the issuance of all Common Stock upon conversion of the Series A Preferred Stock (as defined below), among other items (the “Stockholder Approval”). On the tenth (10th) Trading Day (as defined in the Certificate of Designation) following the announcement of the Stockholder Approval, each share of Series A-1 Preferred Stock shall automatically convert into a Unit. Subject to the limitations set forth in the Certificate of Designation, at the option of the holder, each share of Series A-2 Preferred Stock, Series A-3 Convertible Preferred Stock, Series A-4 Convertible Preferred Stock or Series A-5 Convertible Preferred Stock shall be convertible into one share of Common Stock.

https://www.otcmarkets.com/filing/conv_pdf?id=16469095&guid=lyQ-kasTiMf6B3h