Ardelyx Inc (ARDX)

[Monksdream]

Rolling over. In fact my source for biomed stocks is Barchart. Biomed stocks peaked a few weeks ago.
Barchart has a sector list which currently has 460 issues. It used to be over 500. Barchart won’t include in its sector a stock priced below a dollar.

[Cosa]

Still watching... Not going to add until it hits $4's.

[ErnieBilco]

I'll be fine, my cost basis was $1.13 - $1.33 per share so my exit was fine, I should have gotten out at $9 but then I started thinking about every move mismanagement was making to drive the price down - I think it still has much downside to go.

I could be wrong but I made money which is what I always attempt to do.

[Mr.Mister]

You'll regret it in 2 and a half weeks.

[ErnieBilco]

The chart looks like a dumpster fire on its way. Glad I let go of my dreams for ARDX being a winner, I did well but was hoping for a bigger runner. Will most definitely see $6s maybe even lower.

[enthalpy]

Engulfing candle today. Might be the start of the run up in April.

[ErnieBilco]

OUT

[ErnieBilco]

Well obviously I missed the best exit. I'm sure they don't care about sales they just set the price insanely high in order to show imaginary value when they find a taker to buy this pig in a poke. Very disappointed in what I see happening here.

[Cosa]

Tutes now hold 100 Million more shares than back in 2022

From back in November 29, 2022. I uploaded this to my image gallery.
https://investorshub.advfn.com/uimage/uploads/2022/11/29/ibdcjus-ardx-so.webp

Now:
https://fintel.io/so/us/ardx

[ErnieBilco]

management and the BOD are driving it into the ground, my guess is so they can try and sell it on the cheap to make bank on the excessive grants and options they have been throwing all over the place, hell even the guy who just started is in line for over 200K options.

I used to be extremely bullish on this ticker but management is proving to only be interested in themselves.

LOOKING FOR THE EXIT NOW THAT IT BROKE BELOW MY "$7.50 IS AS LOW AS IT MAY GO" POST.

[Monksdream]

ARDX under $10

[ErnieBilco]

Keep throwing those freebie shares around you clowns are gonna drive this down to .80 again. Total shitshow at this point.

Very very disappointed in this group of self dealers at the expense of shareholders. Keep up the BS and there won't be anything to sell besides worthless shares and a pipe dream.

[Whalatane]

https://www.healio.com/news/nephrology/20231110/video-drugs-in-the-pipeline-for-hyperphosphatemia-management?utm_source=selligent&utm_medium=email&utm_campaign=news

Kiwi

[Cosa]

Not much support below. I took profit on the way up and still holding about 40% of my shares, then sold cover calls on nearly 80% of the shares I had left. The market cap is still a little high at $1.8B. Just watching this patiently.

[Whalatane]

Yep they are definitely positioning for a sale .
So the big question will be sales of Xphazoh , and the UNCY pivotal trial with OLC .
UNCY has a number pf presentations at a major EU conference in May....trial results in June
So don't expect any deal until at least results of that trial ( the only near term competition ) is known
JMO
Kiwi

[ErnieBilco]

And there it is They hired an M&A guy, why would they bring on more dead weight unless they plan to sell out?

[ErnieBilco]

Great insight as always, Thanks

[Whalatane]

If they were only selling IBSRELA they would probably have been bt out already or negotiating a sale now. That drug has found a niche and is in demand.
Xphazoh is the unknown and may depend on what happens with UNCY's final trial with OLC .

If the final OLC trial succeeds ...that Co ( UNCY ) is very likely to be sold. Then the buyer will price OLC as less expensive then X ...for all those who hate the generics, and can afford the co pay of the new brand phosphorous lowering drugs.
OLC is 3 small pills a day swallowed with meals
X is 2 small pills ...1 in am , 1 in pm.
The advantage of OLC is that its a " condensed " version of Fosrenol ... a drug my wife already prescribes , so an easy transition

JMO
Kiwi

[ErnieBilco]

Thanks, but do you think ARDX wants to remain a stand alone company or looking to sell out for cash???
With all the options and grants they have be tossing out to employees it appears to me, just a lil guy with no biopharma background, that they are setting themselves up with their golden parachutes. Again nothing more than my own gut feeling.
I take it UNCY is your most likely winner.

[Whalatane]

Ernie ...some thoughts on ARDX's strategy .
IBSRELA sales are strong ...co pay is around $400 a mth I think which this mostly working age population van afford.
With Xphazoh ...they may be following an Amgen / Repatha strategy .
When Repatha was first launched Amgen wanted $14,000 a yr for the sub Q drug . Insurers created huge roadblocks for coverage and most patients wouldn't pay the co pay anyway .
2 years later with poor sales Amgen cut the price to about $4,500 -$6,000 a year and insurers started covering , Co pay for patients ( I now use the drug ) is roughly $120 a month ...and sales have gone up significantly.

ARDX may provide discounts to patients ( help them with their copay ) to get them started ...then if they are still on X a year later slowly reduce their subsidy.
If UNCY's final trial succeeds with OLC ...one small pill with every meal ...swallowed not chewed ...they may / will be forced to lower their price when OLC launches ( maybe in 2025 ) assuming OLC is less expensive .
Theres also a question about the dialysis bundle ...will X and OLC be in the bundle ( which prefers generics ) or outside of the bundle enabling MD's to more freely prescribe

JMO
Kiwi

[ErnieBilco]

What is a company worth when the patients that need your drug can't afford it?

Management better figure something out fast or it'll be under $5 in no time.

Only other thought is a buyer is actively driving it lower before making an offer BUT if the drug is priced out of reach, why would they want it?? ARDX many have screwed the pooch and will now reap the consequences of a stupid decision.

[ErnieBilco]

Anything is possible but not likely when XBI only holds 1.2% of ARDX

Let's see if ARDX can claw its way toward even for the day.

[enthalpy]

Xbi is down 3% today pulling ardx down with it.

[ErnieBilco]

Well obviously someone with a much larger stake didn't take very kindly to Rep Carter's legislation unless shareholders are losing faith in the C suite who seem only concerned about handing out round after round of shares to insiders and new hires before they show they are even worth a paycheck let along freebies.

[Whalatane]

Its a plus for ARDX if X is kept out of the dialysis bundle .
X is Tenanapour ...same drug as used for IBSC.
Problem is the Co charges more per gm for the dialysis patients then for the IBSC patients
IBSC cost is $1200 a mth and patient co pay is about $400 . Generally a younger working age population.
Dialysis patients average age is mid 60's I think with limited income since they are in a dialysis chair 4 hrs a day , 3 times a week. .......yet ARDX is charging them a premium for the same drug !!!!

Kiwi

[ErnieBilco]

Thanks, now I have a better understanding of the process, Carter is actually working on the patients behalf, I can appreciate that.

The $3K a month for X seems unreasonably high - Glad I'm not one of the poor patients or a patient at all.

[Whalatane]

Ernie. I sold my position in ARDX some time ago ...see earlier posts and in full disclosure hold a position in UNCY .
The advocates for dialysis patients asked Rep Carter to represent their interests , present their concerns.
The most affordable phosphorous lower drugs are all generic. Problem is the patients hate them and most are nowhere near serum phosphorous goals. .
ARDX's X and UNCY's OLC are more patient friendly drugs likely to benefit these patients .

The problem is paying for them . In X's case around $3,000 a mth ...tier 5 means patient copay is around $1,000 a mth.
None of my wife's patients can afford this ...so won't be getting X unless ARDX provides a generous co pay buy down / coupon. .
If X ( and OLC ) go into the dialysis bundle it will severely limit any additional funds for X or OLC ....thats the concern and why Rep Carter is pushing legislation to keep the new phosphorus lower dugs out of the dialysis bundle .

Above is my layman's understanding of the issue.

Good luck
Kiwi

[ErnieBilco]

Like most things gooberment related, I just can't think Stupid like they can. Why should any representative be involved with such things? Shouldn't the most affordable drug be used since they are spending my money? If the makers of X want to limit their sales to self pays it is not the gooberments business.

I have lost faith in ARDX and have begun reducing holdings in all accounts.

[Whalatane]

Ernie The dialysis payment bundle puts a cap on what the govt will pay thru Medicare / Medicaid for dialysis treatment .
Since the payment is capped ,it limits funds for new more expense brand drugs ( Xphazoh ) ...in favor of existing generic ( Selevmar ) .
Rep Carter is trying to delay this for several years to make X more affordable for dialysis patients ...unless an IV binder is approved ( which is unlikely near term )
Kiwi

[ErnieBilco]

I'm a slower reader but what I take from this is that Rep Earl L. "Butthead" Carter is in someone's pocket looking to delay oral binders until someone he must know gets an approved IV binder. Seem very contrary to the needs of the kidney community's needs NOW not 10 years from now.

Where do people find these fools to pretend to represent us?

Please explain how I'm wrong.

[Cosa]

Thanks for posting

[Whalatane]

1 min read
SAVE
Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle

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Key takeaways:
The Kidney Patient Act would delay placement of oral phosphate binders into the dialysis payment bundle.
Binders would be placed in the bundle if an injectable version receives FDA approval.
Congress is reviewing legislation that would delay inclusion of oral phosphate binders into the End-Stage Renal Disease Prospective Payment System bundled payment system.

NNI0324Carter_Graphic_01
CMS currently has plans to include oral binders in the bundle by Jan. 1, 2025, but the Kidney Patient Act (H.R. 5074), sponsored by U.S. Rep. Earl L. “Buddy” Carter, R-Ga., would amend the American Taxpayer Relief Act of 2012 to delay inclusion of the binders until 2033.

“Ensuing that the pending inclusion of oral-only drugs in the [End-Stage Renal Disease] Prospective Payment System (PPS) bundle meets the needs of the ESRD community is a priority for Kidney Care Partners, so we’re encouraged by the recent activity in the House of Representatives on this policy,” Mahesh Krishnan, MD, MPH, MBA, FASN, chair of Kidney Care Partners (KCP), told Healio.

“Without congressional action, this harmful policy would exacerbate the challenges the kidney community already faces, including diminished access to innovative therapies, insufficient reimbursement and limited or nonexistent choice of insurance coverage for patients,” KCP, a kidney community advocacy group, said in a press release.

According to language in the bill, placement of oral drugs indicated for the “reduction, management or control of the serum phosphate of an individual” would be delayed until 2033 unless “an intravenous drug indicated for the reduction, management or control of the serum phosphate of an individual has been approved by the [FDA].”

The General Accounting Office (GAO) released a report last November reviewing plans by CMS to include oral phosphate binders in the PPS by 2025. The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
References:

[ErnieBilco]

8K announcing $50mil term loan into 2027, see if they can strings a couple green days together before they shoot themselves in the foot.

[enthalpy]

This is going to be 12 to 15 in the coming weeks!!!! Wow!!!

[skitahoe]

Any idea what started this move, it's up about $1 from the low of the day.

Thanks,

Gary

[Cosa]

The shorts got burned if they tried to play that bear flag scenario.

[Cosa]

Thanks for sharing that info. A bad board can destroy value. OS History below.

Current 232.7 million. +14M That would put us around 246 million OS

Date OS by the Millions
2023-09-30 228
2023-06-30 215
2023-03-31 207
2022-12-31 159
2022-09-30 165
2022-06-30 146
2022-03-31 131
2021-12-31 104
2021-09-30 104
2021-06-30 100
2021-03-31 97
2020-12-31 90
2020-09-30 89
2020-06-30 89
2020-03-31 89
2019-12-31 64

Source https://www.macrotrends.net/stocks/charts/ARDX/ardelyx/shares-outstanding

[ErnieBilco]

1st let me say I have been very bullish on ARDX from the beginning but I now doubt their ability to progress. It seems everything management and the BOD are doing is to enrich themselves not shareholders, just today the BOD directors decided to add almost 14 million shares to their employee benefit plan - THAT'S ALMOST $140,000,000 TO THEMSELVES while the company remains in the red. When such absurd self dealing occurs it is a giant red flag. Additionally, why would they price their new drug at a price that patients and insurance companies will not cover IMO? Seems it is all about the C suite and the hell with the actual shareholders of the company.

I could be wrong but with each passing day and other competing products in the pipelines of other companies the value of ARDX becomes less compelling to me, hell I was calling for $30 a long time ago but now, seeing this absurd compensation package they have dealt themselves I doubt it sees $15 they are just too greedy to be a benefit to shareholders.

Rethinking my position here which is a direct result of how management is handling the company's fiduciary responsibilities.

[Cosa]

$10B market would be a dream for me. That would put us at $45 a share. I can wait a few years...

[Whalatane]

I sold my position in ARDX in the $4's...and was surprised by the guidance for IBSRELA......so definitely sold to early .
Kiwi

[Whalatane]

I sold my position in ARDX in the $4's....and have held a position in UNCY for some time.
ARDX's XPHOZAH (2 small pills a day ) is an obvious competitor to UNCY OLC ( 3 small pills a day )
The main reason I no longer own ARDX ( and I was surprised by the positive guidance on ISBRELLA ....basically the same drug just priced lower per gm ) is because of the pricing for XPHOZAH
ARDX has priced X at around $3,100 a month . Kaiser has X at Tier 5 which means a copay of around $1,000 a month to the patient
So without ARDX buying down the copay ...I doubt many of these dialysis patients ( who are often low / moderate income ) can afford it .

To date none of the 3 dialysis clinics my wife rounds are using XPHOZAH ...primarily because of the prior approval paper work and being unaffordable to her patients .
The Nephrologists are interested in X particularly for those considered intolerant to binders ...but PA's and cost are major hurdles.

UNCY has yet to announce their pivotal trial is fully enrolled ...that IMHO will be a major catalyst .
They need to carefully / slowly increase dosing of OLC to reduce serum phosphorous below 5 before the end of the 12 wk trial ......going slow will reduce side effects / AE's .
Assuming their pivotal trial succeeds I expect mgt / bod to sell the Co to a large Pharma already in the CKD space . If they go it alone they will raise capital ...and then on approval need to price OLC at a price patients and payers can afford.
JMO
No position in ARDX and currently long UNCY
Kiwi

[ErnieBilco]

They need to reign in the stock options if these people are being paid a salary. Rosebaum is the worst offender of constantly selling the stock down for cash. If they are drawing a salary STOP the options they are killing every run the stock gets with employees cashing in for themselves with no regard for shareholders. It's blatant and disgusting almost like a pinky stock.

[skitahoe]

I've listened to the webcast and looked through the quarterly, it looks to me like things are advancing nicely. Apparently more was anticipated as the stock was down dramatically after hours in reacting to the quarterly. Sometimes it's foolish to think that sales growth will simply go through the roof instantaneously. $1 billion in earnings should be worth a market cap in the $10 to $30 billion range, if it takes a few years to get there as I see it, the company is moving in the right direction.

Gary

[Cosa]

Good luck bro! Market cap is sitting at $2B which is a little heavy for the amount of current revs. But they did PR earlier this year that they believe the potential revenue for Ibsrela is $1B. If this does play out, then $2B is peanuts and the SP could go much much higher. Especially if Xphozah starts taking off in the next year or two. But the company is growing so the story is not written yet...


The company forecast IBSRELA to bring in more than $1 billion in annual net product sales at its peak, according to its press release on Monday. It also said it expects to generate $2.5 million in product sales of XPHOZAH in the first quarter of commercialization of the treatment designed to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.

[skitahoe]

I've just taken a position today. I would suspect that if revenue is increasing, the way I've been told it is, they won't be able to hold it down that long. If I remember correctly, they report later this week, let's see what happens then.

Gary

[Cosa]

They can move the price wherever they want. Remember after Xphozah approval they held this at $3.50 with 44 million shares traded

[ErnieBilco]

Thanks for your informed information. I got in RNLX at .40 so I feel pretty safe there.

[Whalatane]

Your other 2 positions ...PROK amended the trial design

In light of these results, the US-based company plans to update the protocol of its ongoing Phase III clinical trial REGEN-006 (NCT05099770). The study will now enrol patients with an estimated glomerular filtration rate (eGFR) between ≥20ml/min/1.73m² to ≤ 35ml/min/1.73m² to focus on the most severe CKD patients.

This is a very narrow eGFR range to find enough patients for a pivotal P 3 trial .....and if successful the therapy would only be approved for those in that eGFR range .
I had looked at RNLX previously .....they charge $950 for their test that I think the insurers will want the patient to pay most of so,I passed on that
JMO
Good luck
Kiwi

[Whalatane]

UNCY is high risk and we can discuss on that board if U like.
ARDX has Isbrella which is selling well . Xphozah sales yet to be determined but IMHO probably difficult due to the premium pricing Co has decided on.
Kiwi

[ErnieBilco]

Looking for much more upside and only limited retraces along the way. $ARDX