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

Agree. He's lining my pockets as well.

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

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.

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

From poster RMB

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

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

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

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

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

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

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.

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

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!

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

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

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.

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.

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

Relax ...its an incentive RSU /option ...doesn't vest for a yr and PPS has to be above where its is now for him to make any $ .
He's the new commercial officer ...U want him to have a huge incentive package

Kiwi

WhoTF is approving all these freebies to insiders? They are bending common shareholders over and not even saying thank you.
TIME FOR SHAREHOLDERS TO REIN IN THE OUT OF CONTROL SELF SERVING BY INSIDERS INCLUDING RAAB AS THE MOST ABUSIVE RAT ON THE SHIP. AND THEY ARE PAID HANSOMELY TOO BOOT.

I picked up shares today at the open. Seems undervalued considering script growth, although I understand the risks going forward.

RMB. From a quick look at the insider sales in 2024 . The biggest sales lined up with the period of internal company discussion over whether to go the TDAPA route for Xphazoh or not . This culminated with the resignation of the CMO. Susan Rodriguez on May 24 th followed July 2 on the Co's announcing they would not go the TDAPA route but would instead sue the CMS ....which lead to a 32 % drop in the stock .

These insiders were selling knowing how analysts would react ( down grades etc ) if the Co decided to give up the first 2 yrs of guaranteed income from X thru the TDAPA route and instead sue the CMS and risk little to no income from X if the courts sided with CMS ...and the Kidney Patient Act was defeated.

I had been out of ARDX after its approval and missed it run to Dec 23 highs ...but did buy back in after this 32 % drop in July .

Ibresla sales are going well but the success of any investment in ARDX at these levels requires them to have a future selling Xphazoh in the US .
To do that ARDX needs the Kidney Patient Act to pass and / or the Co to prevail in court vs the CMS

JMO
Kiwi

Was reading that in Q2, institutions were net buyers of the stock. But, according to this, company insiders did nothing but sell the stock the last couple of years. Not familiar with this site but here it is:

https://www.insiderdashboard.com/search?page=1&query=ARDX

RMB. A stay is a definite possibility until the case is decided.
Also ..... Forcing the oral pho binders into the dialysis bundle creates a huge challenge for the dialysis providers . They become responsible for storing and dispensing these binders and few appear set up for that .......and doubt they will be fully compensated for their extra costs .
Serum pho management is not part of the dialysis procedure . Its part of reducing risk ...but not the actual procedure the providers get paid for
Kiwi

Kiwi, on the Yahoo board, I read where some mentioned that in the last CC ARDX mentioned that they were waiting for govt lawyers to be assigned to the case after which ARDX's lawyers could have some conversations with the opposing side. Some on that board speculated that if no resolution occurs during those talks, that the judge may even order a stay (something about people's lives and quality of life being at stake). So wonder if any of those are a possibility.

RMB. ARDX and UNCY are ( IMHO ) huge bets on the Kidney Patient Act passing and / or ARDX prevailing in their lawsuit against CMS .
The Kidney Patient Act probably won't be decided / voted on , till EOY .
Kiwi

Kiwi, considering most would say that the most recent earnings report was very good or even excellent, why has the pps not reacted?

Is it all related to Congressional action and the lawsuit against CMS? Market must be thinking that scripts for X will not match expectations.

Thx Ernie A Nephrologist my wife works with has been trying to prescribe Xphazoh for some of his patients but is running into problems ....insurers want the patient to fail on 2 other binders first , Medicaid at least in CA does not cover and those on Medicare can't use the companies coupon to reduce their copay .
If they find a work around I'll post it here .
Those not on Medicare or Medi- Cal don't have this problem ...except for the prior auth to fail 2 binders first ...however Medicare / Medicaid make up over half the US dialysis population I think
The fact that Nephrologists my wife knows are trying to use X demonstrates that there is interest in trying it...... and that most prescribers in the dialysis universe probably know about it.

( my pre expresso morning thoughts ...:---)

Kiwi

Editor’s note: This is an automatically generated transcript. Please notify iwaters@healio.com if there are concerns regarding accuracy of the transcription.

Going back to the tenapanor drug, I'm interested in seeing further studies of how we optimally combine this with phosphate binders. It's a twice-a-day drug, which technically doesn't have to be taken with meals, although in the trials, they tended to give it with the meal. The expectation is that we would combine it with phosphate binders. There's a recent publication by a Japanese group doing that, and they lowered the phosphorus substantially in people who were on binders, but not achieving goal. And they increased the proportion of patients getting to a phosphorus of less than, I think they wanted, less than 6 [mg/dL] from 30% with the placebo pill to about 70% of the patients who added the tenapanor to their binder. So that's really exciting. The next is a drug, which just has a code name, EOS789, which is a pan-phosphate inhibitor. It inhibits NaPi2b and two [inorganic phosphate] PiT transporters, which are all phosphate transporters in the gut. This agent, in at least a phase 1 study, did seem to be pretty effective at lowering the proportion of phosphorus absorbed in meals. We're going to need a lot more data on how tolerable it is and how efficient it really is in improving phosphorus in hemo[dialysis] patients going forward.

And then the third agent is a phosphate binder of the lanthanum type. So, we already have lanthanum carbonate. It’s a pretty potent drug. [There are] a lot of problems with the GI side effects, and the pills are extremely hard and have to be chewed thoroughly or crushed in order to be effective. Another company called Unicycive has developed lanthanum dioxycarbonate. And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated. It's kind of microparticles. And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America). And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL. And that's kind of exciting. I think we need more potent phosphate binders.

VIDEO: Drugs in the pipeline for hyperphosphatemia management...this is on Helio / Nephrology and unfortunately I can apparently link it

Kiwi

Agree . I also need to correct an earlier post re Medicare patients using the Co's coupons

They smashed estimates again! Wow! Very impressive.

Good report for both Xphazoh and Ibsrela . Ibsrela rev doubled over same period in 2023 . Xphazoh was $37 m for the qt ...impressive . Will be a big deal if they can keep X out of the dialysis bundle so Nephrologists can freely prescribe . Dialysis patients that have issues with constipation ( about 10-20% of population I think ) are prime candidates as they want a looser stool as well as reduction in serum pho

Kiwi

ARDX Reporting on a day market is getting throttled.

Cosa. There may be a high stakes negotiating game going on here .
ARDX is charging a premium for dialysis patients vs what they charge per gm for their IBCS ( Ibresla ) patients. ....its the same drug Tenapanor ...just different strengths .

Thanks for info. Now I clearly see why they want no part in that bundle.

Opinion by Dew who I think is ex Harvard Med

$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

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

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

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

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

The dialysis bundle explained and its relevance to ARDX and UNCY

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