Ardelyx Inc (ARDX)

[Whalatane]

Re UNCY we should get an announcement before the open on Mon. Latest would be Thursday as per material info disclosure regs . They are using the 505(b) 2 pathway ( stripped down version of usually FDA multiple trial pathway as OLC is only a reformulation of an existing drug ...Fosrenol ) .
They increased the numbers in their final trial with dialysis patients , Octagon made a large investment recently ( I assume they did a ton of DD ) ...so it will be a real surprise ( and trash the stock ) if their application is rejected.

Re ARDX IMHO Co over priced Xphazoh vs what they charge for Ibresla ( it's the same drug Tenapour ) . Based on Ibresla pricing X should cost around $2,000 ....not $3,000 a mth . Medicare patients can't use coupons so would need to pay around 25% of the cost . Risk is that MD's start prescribing X less if they expect it not to be available Jan 1st .
Congress is back in session for at least a few weeks after this election ....so hopefully we'll get some action / more co sponsors for the Kidney Patient act .
I doubt dialysis units are set up properly to store, record and distribute X so it's a mess for all concerned ....unless CMS and ARDX come to some agreement / settlement or the govt acts
JMO

Kiwi

[rosemountbomber]

Thanks Kiwi. If by Friday you mean yesterday, then we didn’t get a negative PR. Hoping for something +ve early this coming week.

[Whalatane]

ARDX mgt has argued that including X in the dialysis bundle will limit access to the drug for high serum pho patients . This is likely to be true eventually since the way the dialysis bundle works , expensive brand drugs will be prescribed less than cheaper generics.
It won't make any difference in the first 2 yrs if they had signed on to the TDAPA process.
Meanwhile ARDX wants Nephrologists to keep prescribing X even tho those on Medicare won't be covered if CMS proceeds in Jan 2025 . ARDX argues that if their Medicare coverage is dropped these patients may still be covered by ARDX Assist

The Kidney Patient Act looks to me to be an easier win if they can get 50 bipartisan co sponsors ( currently at 38 )

Meanwhile nail biting time with UNCY . Deadline for FDA decision is Sun Nov 3 .....plus 4 days for disclosure regs ( if necessary ) . Fear is always an after hrs -ve news release on a Friday
Kiwi

[rosemountbomber]

What gives you so much confidence of a win against CMS?

[biotechrocks]

2 approved drugs with stellar revenue growth qtr over qtr. Victory against CMS coming soon. And then M&A activity starts. Easily a 3x from here but most likely 5-8x on the upper side.

[Whalatane]

https://www.congress.gov/bill/118th-congress/house-bill/5074

Currently we have 38 co sponsor . Current opinion is that we need 50 bipartisan co sponsors to be confident of victory ...by EOY

ARDX ( Xphazoh ) will lose coverage for those on Medicare starting Jan 1 if CMS prevails since mgt did not apply for TDAPA in the new CMS program
Kiwi

[Whalatane]

RMB. It all comes down to getting a court injunction to prevent CMS from pushing new oral binders into the dialysis bundle OR passage of the Kidney Patient Act ...now 38 co sponsors ( ideally U want 50 and bipartisan ) ...BEFORE EOY .
Demand for Ibsrela and Xphozah is strong ...particularly Xphozah ...however the patient mix for X is 40 % non Medicare and 60% Medicare . They lose the 60% Medicare if CMS prevails as they didn't start the TDAPA process which would have generated $ in the first 2 yrs but cost them scripts after that ( because of the way the dialysis bundle works )
So theres significant upside IF they prevail against CMS and IMHO the Kidney Patient Act has a better chance than their legal effort.

Meanwhile ...UNCY ...FDA to notify Co by by Nov 3 if their NDA is accepted . UNCY's OLC is also a new oral pho binder and will benefit from any legal or legislative win ARDX achieves . UNCY's OLC is actually a stronger at reducing serum pho , 1/3 rd the cost of X and doesnt cause as much diarrhea .

Kiwi

[Cosa]

Don't worry about the share price, it's rigged. Eventually they wont be able to hold it down.

[rosemountbomber]

Well not anymore. All afterhour gains evaporated.

[rosemountbomber]

Market seems to like earnings released today. Good increases in sales of the 2 drugs. Revenue increase but earnings decrease. Increased SGA costs. Bugs the heck out of me when they don’t control spending better but as long as sp advances.

[rosemountbomber]

I hope so. On a Yahoo Finance app I have it says avg price target is $11.65

[Cosa]

The two biggest bull runs of this ticker started in November of 2022 and 2023. 3rd times a charm?

[Whalatane]

From Rose on X

Rose Han
@itsrosehan1
$ARDX

Ardelyx gains bipartisan support for potential kidney disease legislation

Ardelyx, a biopharmaceutical company focused on developing innovative treatments for kidney and cardiorenal diseases, may see increased interest following recent legislative developments. A bill related to kidney patient care, H.R.5074 - the Kidney PATIENT Act of 2023, has gained additional bipartisan cosponsors in Congress.

The bill, initially introduced by Rep. Carter, Earl L. Buddy [R-GA-1] on July 28, 2023, has now attracted 4 new cosponsors, bringing the total to 37. The new cosponsors, all added on October 18, 2024, include:

1. Rep. Meeks, Gregory W. [D-NY-5]
2. Rep. Velázquez, Nydia M. [D-NY-7]
3. Rep. Gonzalez, Vicente [D-TX-34]
4. Rep. Horsford, Steven [D-NV-4]

This growing bipartisan support for kidney patient-focused legislation could potentially benefit companies like Ardelyx that are developing treatments for kidney-related conditions. While the bill's specifics and its potential impact on Ardelyx's business are not detailed here, increased congressional attention to kidney health issues could create a more favorable regulatory and market environment for Ardelyx's pipeline products.

Investors in Ardelyx may want to monitor the progress of this legislation, as it could have implications for the company's future prospects in the kidney disease treatment space.

Current view is that we need 50 cosponsors or more ...bipartisan ...for this to pass
Kiwi

[Cosa]

That would be disastrous for the entire bio industry. Clinical studies from lab to commercial takes at least $500M, that's bare minimal. If the government steps in and reduces a company's potential earnings from a drug, then this will hinder future developments for all bio. This is also the point of patents. To insure the company of the discovery has sole rights to the revenue. So in my opinion, No it will not be in favor. And these big pharma's definitely will have a hand in that No.

[aBeezlee]

The court will move in CMS' favor, no? Surely they have the resources to pay off the right people.

[rosemountbomber]

Well hopefully an overreaction. Sitting in SLC waiting for last leg to PDX.

[Whalatane]

He's just a guy on X looking at the briefs filed in court vs CMS .
Hope U make it out of Florida in time ...looking dicey per the news I see .
Good luck
Kiwi

[rosemountbomber]

Who is Richard C? This is the only guy I can find:

https://www.hetwebsite.net/het/profiles/cantillon.htm

[Whalatane]

Likely reason for sell off ...CMS likely to prevail

Richard Cantillon
@cantilloncap
·
36m
My best guess is CMS wins and Court declines motion for prelim. injunction & sets a new schedule for MSJs. A better bet is HR5074 but I think we need 50 co-sponsors to really feel comfortable here. $ARDX

[Whalatane]

Why access to these new serum phosphorous lowering drugs is so important

Patients receiving maintenance dialysis for chronic kidney failure have a high mortality rate, with 5-year survival of less than 50% after dialysis initiation in the US.3

Cardiovascular complications are the leading cause of death, with 40% of deaths attributed to arrhythmia or cardiac arrest.3
Systemic complications of chronic kidney failure include anemia, hypertension, and mineral bone disorders, such as hyperphosphatemia and hyperparathyroidism.

Dialysis treatment–related complications, such as vascular access dysfunction, infections, and hemodynamic instability during dialysis, are common and may cause distressing symptoms, including cramping, post-dialysis fatigue, and poor quality of life.4

Kiwi

[Whalatane]

From Frank on X

Multiple catalysts on the very near term horizon.

CMS / HHS litigation - hopefully headed to PI late
October as per Jeffries analyst Dennis Ding's call last
week
HR5074 - Adding sponsorship daily -today added
Maxine Waters . Hopefully just a matter of time https://congress.gov/bill/118th-congress/house-bill/5074/cosponsors
3Q Earnings- recent RECORD Rx counts as per IQVIA
s/ lead to another GREAT earnings release
Fosun Pharma - Chinese approval expected by end of
the year
ROW partnership- timing TBD

Maxine Waters just became a sponsor of the Kidney Patient Act . Black Americans are a high % of the dialysis population ( compared to their over all % of US population ) and would be disproportionally affected by reduced access to Oral pho drugs ....if the current CMS plan goes into effect Jan 1st
This bill to keep oral pho binders out of the dialysis bundle is supported by members of both parties

Kiwi

[nsomniyak]

I can’t give you the skinny on an ARDX but I certainly am not concerned about the class action lawsuits. Those are just the ambulance chasers that get after every single stock.

[fung_derf]

I took a fairly small position here today. Thanks

[Whalatane]

Another serum pho drug OLC by UNCY is about 9-10 mths away from approval ...assuming FDA accepts their application in Nov .
They face the same CMS bundle decision in Jan and will also be affected by the results of ARDX's law suit and the Kidney Patient Act.
UNCY is trading around 40.c and faces a Naz delisting mid 2025 if they don't get their PPS above $1 or do a reverse split.

Whats important to know about both OLC and Xphazoh is that they are small pills that can be swallowed. Currently the available drugs are usually large pills and need to be chewed or crushed and taken with apple sauce ...so patient compliance is poor.

Xphozah ( ARDX ) is criticized by some for causing diarrhea in roughly 40% of those who try it ....or at least creates a " loose " stool .
The " loose " stool effect is actually a side effect plus for many of the dialysis patients that complain of constipation . It makes them feel more normal.

Kiwi

[fung_derf]

Thank you. Very articulate yet succinct.

[Whalatane]

Fung ...Ibserla for irritable bowel syndrome is seeing strong uptake but the real potential $ maker is Xphozah for serum pho control ( important for dialysis patients )
The CMS has scheduled Xphozah to be included in the dialysis bundle starting Jan 1st /25.
This will limit prescribing of this new drug ....as explained in previous posts .
The CMS decision is being challenged by both ARDX thru legal action and the Kidney Patient Act currently in the Senate .
The ambulance chasing lawsuits are around ARDX's decision not to allow Xphozah to be included in the dialysis bundle process ( which is a series of steps allowing ARDX better access in the first 2 yrs ...but eventually less scripts written later ) . This decision will mean less Xphozah income in the next year ....but potentially a lot more later if they prevail in their legal action ( or the Kidney Act pass's )

Kiwi

[fung_derf]

I came across this stock and was doing some research on it. I realize they are not yet making earnings, but are expecting to over the next couple years. The next step was the chart, which looks fairly promising right now. Last step was to read the current news and that's the red flag. Lawsuits coming out the yingyang.
So, my question is, can someone with common sense explain to me the real scoop?
I am seeing long term resistance around $9. Currently $6.61

[Whalatane]

RMB. If ARDX spikes over $8 on being granted an injunction , I'll probably sell .
I bt back in July on the price drop and my views re their pricing are still the same

Whalatane
Member Level
Re: ErnieBilco post# 1524
Tuesday, July 02, 2024 1:18:02 PM
Post# of 1604
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

Happy travels thru the canal
Kiwi

[rosemountbomber]

Thanks for posting Kiwi. Great news- highly likely. Question is how high this will rise and if the rise happens before the injunction then we could have a sell the news event.

Going through the Panama Canal tomorrow - an all day event.

[Whalatane]

$ARDX - ***UPDATE***
A large Wall Street bank hosted an investor call with DC legal experts re: ARDELYX, INC. et al v. BECERRA et al

Conclusion - Ardelyx is highly likely to be granted a Preliminary Injunction by Judge Beryl Howell as early as late October '24. This temporary court order prevents the Centers for Medicare & Medicaid Services (CMS) from acting on the challenged policy until the court makes a final decision. A trial would not likely take place until late 2025 and could last months based on the court's calendar and reliance on interpreting the Chevron Doctrine ruling which was recently overturned at the US Supreme Court on June 28, 2024. This case is also highly likely to face appeal and that could push the final ruling well into 2027.

My opinion- This favorable ruling enables both sell-side and buy-side analysts to project Ardelyx's revenues and cash flow through 2026 and likely into the first half of 2027, providing investors with greater confidence in the stock's valuation. Therefore, the stock should grind higher into earnings and beyond

From Frank on X

Kiwi

[Whalatane]

From the ARDX presentation re the Kidney Patient Act that...if it pass's ... will benefit both ARDX and UNCY
Frank
@justfactstruth
$ARDX -FROM CANTOR CONFERENCE
HR 5074 and S 4510
We have 24 Sponsors / Co-Sponsors and this is truly Bi-Partisan with strong support

It has already passed the House Ways & Means Cmte and the Energy and Commerce Cmte so waiting for a floor vote.

We have many avenues for this to be settled and are hopeful to hear something by the end of the year before patients lose access to this drug
This can happen by Stand Alone HC Bill, Omnibus Bill / Mini or in the CR inclusion


Kiwi

[Cosa]

Agree. He's lining my pockets as well.

[Whalatane]

Ernie. Raab has got ARDX from around 60c in mid 2022 to over $6 today ....he's earned his $ .
10,000 shares in mid 2022 would have cost you $6,000 .....thats now worth over $60,000 .
Be happy

Kiwi

[ErnieBilco]

And here comes Raab to line his pockets with freebie shares AGAIN - this crap is just too predictable there should be an SEC investigation into this profiteering by the CEO.

[aBeezlee]

Basically I have a few months to accumulate. Maybe we'll see low 5s before this is settled?

[Whalatane]

From poster RMB

“(Bloomberg Intelligence) - Ardelyx, Akebia Therapeutics and other makers of oral-only, end-stage renal disease (ESRD) drugs will likely see Congress pass legislation during the lame duck session
that blocks an administrative proposal to move the therapies out of the Medicare Part D program. Some lawmakers have expressed concerns with the regulatory decision, and a delay won't impact federal finances. Passing the bill would remove some near-term uncertainty around utilization and
pricing for newer drugs. (09/04/24)
1. Lawmakers Ramp Up Scrutiny of Regulatory Change Ramped-up congressional oversight of Medicare's implementation effort to incorporate oral-only drugs into the ESRD payment bundle should generate enough headline noise to keep the issue front-and-center for action during the lame-duck session. Lawmakers continue to raise concerns about the regulatory change, and have requested information from the Biden administration on the implementation process. But with only a handful of legislative weeks scheduled in September, major policy changes won't make it to the president's desk before Congress adjourns for election
campaigns. The policy change will likely be folded into a broad-based year-end omnibus bill with other member
priorities such as PBM regulation changes and legislation curtailing biotech research with China.
(09/04/24)”

Kiwi

[aBeezlee]

Oh I'm not selling. Estimating $20 within 5 years. Buying at this level is a blessing lol.

[Cosa]

This one just takes patience. But its going 100% from here eventually.

[aBeezlee]

Despite their last ER being positive the price continues to crater. Strange. 🤷‍♀️
Must be related to CMS and X.

[Whalatane]

UNCY also filed their NDA ( note out today ) ....so potential competition for Xphozah if UNCY's OLC ever gets to market
Both ARDX and UNCY need the Kidney Patient Act to pass to see any significant gain in either share price
JMO

Kiwi

[Cosa]

Wow lol. -9% nice share grab by tutes.

[Whalatane]

RMB. So far the Kidney Patient Act has overwhelming support .
There are a number of concerns regarding including oral pho binders ( including the new ones ) in the dialysis bundle .
1) dialysis units aren't set up or apparently prepared to handle the sourcing , maintaining , dispensing etc these drugs....all normally done by the pharmacy There are several types and high volume .
2) A black American Nephrologist in Atlanta is getting attention to her view that the CMS policy would disproportionally affect the black dialysis population .

So passage in an election yr looks pretty good

It's a sell the news event for me unless ARDX finds away to make X affordable to the Medicare population ...which is the majority of those on dialysis.
They may do something like Amgen did with Repatha ...basically cut the price in half in return for greater access ....but don't know how probable that is .

Meanwhile theres UNCY's OLC coming down the tracks if the NDA is filed this week . That pho binder is priced at about $1,200 a mth so the copay may only be around $200 -$300 for those on Medicare and 0 cost for those with coupons

There is a market tho for those that can use the coupons ...for both Xphazoh and OLC ...especially if kept out of the dialysis bundle which the way its set up ...disincentives prescribers at private dialysis units at least ...from prescribing the new oral binders

Kiwi

[rosemountbomber]

So in an election year sometimes things are harder to pass in Congress, but since this is supposedly a bipartisan bill can we assume (yeah I know about assume) there is a pretty good chance of passing so they can brag about what they did? I also agree about something like that warranting a sell the news event, but hopefully stock price is way up on that news.

[Whalatane]

Cosa These are early Xphazoh adopters not on Medicare / Medicaid that the Co has targeted .
Xphazoh is around $3,100 a month ( vastly over priced vs Ibsrela -same drug ) , usually listed as Tier 5 on formularies which requires the patients to pay 25-33% of the total cost....UNLESS they can use the company's coupon which lowers their copay to $0

Medicare / Medicaid patients can't use the coupon and this population is about 2/3rds of the dialysis population and few IMHO will pay the $600- $800 monthly copay.
Non Medicare / Medicaid patients complaining of constipation welcome Xphazoh ( lowers serum pho and also make their bowel movements closer to how they were pre dialysis )...and these are your early adopters.

My interest in ARDX is largely around the Kidney Patient Act passing ...that will probably be a " sell the news " event for me
Good luck
Kiwi

[Cosa]

The real catalyst is revenue IMO. They're at $119M revenue in just two quarters for 2024. If Q3 stuns again, we might be close to $300M this year!

[Whalatane]

Well good call so far today . The real catalyst tho will be passage of the Kidney Patient Act .
Re scripts . The dialysis patients complaining of constipation are the ones most likely willing to try XPHOZAH first ....provided they can afford the copay or use any coupon the Co offers .
Some prescribers definitely feel ARDX is ripping off dialysis patients compared to what they charge per gm for the same drug to IBSC patients ...just an FYI


Kiwi

[Cosa]

IMO 5/6 bucks...is a good reentry point. Xphozah Q2 revenue already surpassed Ibsrela and it's only be on the market for about 2.5 quarters. Market cap is sitting at $1.4B. Just need a little patience on this one, they can't keep the price suppressed for too long. I think Q3 ER (2 months) will be the tipping point if the share price doesn't rise by then. They can't hold it down if the number are even greater than Q2.

Company ends Q2 with approximately $186 million in cash and investments
IBSRELA® (tenapanor) records $35.4 million in net product sales revenue in Q2 2024
XPHOZAH® (tenapanor) launch progresses, records $37.1 million net product sales revenue during Q2 2024
Revenues: Total revenue for the quarter ended June 30, 2024 was $73.2 million

[ErnieBilco]

Looks like someone else with resources wants to get to the bottom of it. I personally made money on it so I won't be part of the Class action. Will be interesting to see if all the insider self dealing will be revealed in the process.

Just watching from the sidelines - Whew dodged this bullet.

[Cosa]

Price manipulation. Look back to October 18, 2023; we traded nearly 58,000,000 shares the day after Xphozah was FDA approved. I think MM's and Broker's colluded. Parked and Bundled retail orders on darkpool. . The price didnt move. Only started climbing a month later in November then went on a bull run for the next two months into January 2024. But this rise came with normal volume as they let orders flow to lit exchanges. Then price targets got raised and they dumped on retail $9 - $10.

But this is speculation and just my opinion and a scenario that I made up in my head. I needed something to justify the large volume with no price movement and the small volume and large price movement. Anyone have a better theory? I would love to hear it.

So after the 2024 Q2 ER, and seeing the excellent sales revenue. Watched the price action tickle just over $6 and drop back down to $5's. It appears the same thing is happening again. I have already added back all the shares I sold back in December/January. And still increasing position to an even larger position than I had before.

[Cosa]

I thought you sold everything and the only way your buying back in is if the price drops below $1.13

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