Ardelyx Inc (ARDX)

[ErnieBilco]

This chart is the absatively the most beautimus I've sawed in a long timo

[ErnieBilco]

Looking good heading into 2024

[Watsonturtle]

Yes. I plan to be this LT. WT

[Whalatane]

JFM hope alls well . As you may know ...my wife prescribes to these patients .
She wants to try Xphozah first as a low dose for those that complain of constipation ...however expects serious insurer push back because of the close to $3,000 a month ARDX wants for this drug .
Insurers are likely to put up a wall of prior approval paper work ...document patient is intolerant to existing binders etc ...and then only cover 2/3rds of the cost ( patient pays the final 1/3rd ) via a Tier 5 drug rating
So I'll be surprised if theres a rapid uptake .
Currently no position
Good luck
Kiwi

[jfmcrr]

2nd largest position. In the green. Planning on holding. Largest position was unintentional; up 125%.Happenstance can be OK....

[CassieW]

Interesting- I don’t hear a lot of negative about Ardelyx. Coming from the NWBO board, this is something I’m not accustomed to! Haha

[Whalatane]

WT. Good earnings report and guidance . X being launched this month .
Do U still have a position ?
Kiwi

[MACH1351CJ]

Does anybody knows if this is ended: During the quarter ended September 30, 2023, the company received gross proceeds of $58.4 million for the sale of 13.8 million shares of the company’s common stock under the company’s sales agreement with Jefferies LLC deemed to be “at-the-market offerings.”

[Cosa]

Today we're up 8% on volume 4.7 million volume and on approval day 10/17 we were up the same amount with nearly 60 million volume. IMO they bundled retail orders and filled it on the dark pool. Just a theory...

Dark pool volume leading up to approval date on 10/17. Dark pool volume explodes 10/18 and 10/19 T+2
Date Dark Pool Volume
2023-10-03 1,589,783
2023-10-04 1,075,138
2023-10-05 2,403,086
2023-10-06 1,327,583
2023-10-09 1,247,816
2023-10-10 2,789,391
2023-10-11 5,980,146
2023-10-12 3,199,710
2023-10-13 3,295,819
2023-10-16 2,930,140
2023-10-17 3,550,624
2023-10-18 27,963,832
2023-10-19 7,146,033

https://chartexchange.com/symbol/nasdaq-ardx/exchange-volume/

[Johnstonj27]

Got a 2 week ban on ST what a joke.. for posting positive messages on Ardelyx... it's all so rigged against retail traders.

[Johnstonj27]

Got a 2 week ban on ST what a joke.. for posting positive messages on Ardelyx... it's all so rigged against retail traders.

[MACH1351CJ]

Because of options that expires on Friday maybe?

[Cosa]

The price manipulation is crazy. 10x volume and they hold it down.

[ErnieBilco]

Record volume but pps just didn't move like most would have, disappointing IMO

[Whalatane]

Sold at $4.06. I tend to "sell the news " . May re enter when I see how well patients transition to Xphozah.
The wild card is the EU. Companies like CSL Vifor in the EU usually buy small specialized CKD companies like this as they have a large well established cardio-renal sales force ...so its an easy bolt on.
I expect them to watch sales / patient acceptance for awhile before moving.
This is not investment advice.
Stock will certainly jump on any buy out spec.
I may re enter later following the launch .
Kiwi

[Whalatane]

Thx for the link. Looks like a broad label and also looks like no dilution to fund launch ....just accessing what looks like a line of credit
So the question is how many can transition thru the risk of diarrhea phase.
Roughly 400k dialysis patients in the US ( maybe more in the EU ) can not get their serum phosphorus to goal .
Currently no partner in the EU which makes this more of a take over play for CSL Vifor IMHO ( They are big in Cardio-Renal in the EU )
All eyes on the launch now .
How many patients can transition to X ?

Kiwi

[ErnieBilco]

It's showing halted so I guess the morning is gonna show which way it's gonna go.

[Cosa]

https://ir.ardelyx.com/news-releases/news-release-details/fda-approves-xphozahr-tenapanor-first-class-phosphate-absorption

[Cosa]

Approved!!

[Jaynes19]

We're all too busy celebrating

[ErnieBilco]

FDA approved and crickets?

[Cosa]

It appeared that way on previous news announcements early this year too. The short term calls printed. I grabbed some lottos to play.

Tutes went from 30% and double there position in the last 7 months. It flipped it from majority retail to majority Tutes. It can run fast as there will be less shares held by retail. Volume will move it, unless mm’s hold the price down somehow with naked shorts. Good luck!

This was from a few months ago…

[ErnieBilco]

I don't know, this ticker doesn't appear to trade like it's about to get approval from the FDA

[Watsonturtle]

Thanks Kiwi. Biotech/pharma across board getting hammered. ARDX and AUPH are good pick ups at this point as they don't need to raise case. E.g., Auph has about 2.5 share points in cash and I expect it to go up in Q3 with milestone payments.

Re ARDX, I am surprised there hasn't been more discussion of ARDX being a target for BO. I am also surprised at the daily volume and volatility.

Re Auph and insurance, keep in mind that they did get a very favorable icer report, so it's hard for insurance companies to push back too hard. I think it's more the types of policies (high deductibles and thresholds) that are being sold ... such policies put a heavier burden on the patients. But, in view of the icer report, the cost of developing and bringing the treatment protocol to market, and the long runway for IP protection, I would not expect auph to be dropping price at this early stage. That's really a call for they buyer of auph. I expect they will be close to a $200M/year run rate for Q3. The RETA BO intrigues me because, as I recall, they were not expected to hit peak sales 2029, with IP protection running out in 2033. Auph would seem to much better positioned.

WT

[Whalatane]

WT. well good luck with both ( ARDX and AUPH )
We seem to be in an Ozempic inspired down draft.....a sell now and ask questions later ...not only in kidney disease drugs but any disease related to diabetes and cardiovascular health as well.
AUPH's drug Lupy seems mainly being used for those with LN and an eGFR below 30 and rapidly declining . Main reason for limited use is push back from insurers re cost of the drug.
Ozempic for CKD will probably be on the market in 2025 so lets hope ARDX's Xphozah finds a market before then.
No position in AUPH
Small position in ARDX
Kiwi

[Watsonturtle]

Kiwi -

Are you still in AUPH ?
NVS has just completed a major trial with Cosentyx for LN. Not sure when they will publish results but it's something you may want to watch for if you're still in that co.

Thanks for the NVS info on Auph. Yes. I still hold my AUPH. Been in Auph since 2017 and other than FB its been my most profitable investment. Sold about 1/2 position after P3 (2019, early 2020) and have been selling calls on the rest ever since for monthly income. Didn't play the run up to 34 well (took some profits, sold some calls, but not enough). Really don't mind the volatility, i.e., I took advantage of the patent dispute to reload under 5.

WT

[Cosa]

Just like Xphozah is already approved for existing indications. Should have been on the market since 2024 lol.

[ErnieBilco]

Ozempic isn't all sunshine and lollipops.

Is Ozempic hard on your kidneys?
Kidney problems

Taking glucagon-like peptide-1 (GLP-1) receptor agonists, like Ozempic, may worsen renal failure or damage in people with kidney problems. Kidney injury can also occur in people who do not have underlying chronic kidney disease while taking Ozempic.Sep 10, 2023

[Whalatane]

WT. Ozempic is already approved for existing indications. There is now wide spread use and a large safety data base. I expect it to be on the market for CKD patients in 2025
Kiwi

[Watsonturtle]

will do some DD. but I would assume it will take years to get to market. WT

[Whalatane]

WT

After one year of treatment, those on dialysis have a 15-20% mortality rate,

So those currently on dialysis continue with the same mortality rate BUT new patients start at a slower rate because their decline in kidney function has been slowed by Ozempic .
Nett result ...smaller dialysis population to sell Xphozah into
JMO
Kiwi

[Cosa]

Very interesting.

[ErnieBilco]

Thank you

[Watsonturtle]

interesting ... that would seem to be a ways out there in time ... and still somewhat speculative. Nonetheless most stocks having revenue tied to dialysis dropped to today. An overreaction I suspect. But don't know. WT

[Whalatane]

NVO stopped their CKD trial at interim for efficacy .
This indicates that their drug Ozempic significantly slows the decline in kidney function ......thus likely diminishing the need for dialysis and drugs used for dialysis patients in the future .
Kiwi

[ErnieBilco]

What happened to cause this drop - the day started out so well and has turned to shites.

[Cosa]

If mono is not approved, IMO the FDA is protecting big pharma revenue. I'm sure the patients prescribed X would greatly appreciate the reduction of daily pills. Also they have limited liquid intake.

[Whalatane]

Cosa. My guess is thats its a 90% probability that the FDA will approve as a combo with the existing binders and probably a 60-70% probability X is also approved as solo use .
The question for me is how fast will the uptake be after approval.
Xphozah will almost certainly require prior authorization ...meaning the MD must certify the patient has failed on the existing generic binders before an insurer will cover. Typically what happens is a patient can't stand Renvela ...so the insurer says ...well try Fosrenol . MD says patient can't tolerate Renvela or Fosrenol ...insurer then says ...Well try Velphoro .
Until all the patient has failed on all the available generics ...then they might OK Xphozah from ARDX.
JMO
Kiwi

[Cosa]

You guys know I'm definitely not a bear. But it is possible that FDA goes against ADCOM. This is two completely different drugs. Just be aware.

https://www.investors.com/news/technology/alnylam-stock-tumbles-after-the-fda-rejects-its-heart-disease-treatment/

[Cosa]

Next week!

[Whalatane]

WT. The Kaiser formulary has Ibsrela at tier 5 $1,800 a mth . I think most Kaiser will pay is 1/3rd of the cost . Not sure of the discounts or coupons the Co might offer.
The key for Xphozah is how Medicare / Medicaid treats it . I think theres a big decision on this in 2025 . Not sure how the whole dialysis " bundle " plays in here re cost either .Any ideas /opinions on the above ?
Kiwi

[Whalatane]

WT Ibsrela scripts have continued to show strong growth . I don't follow that part of ARDX very closely so can't provide any informed opinion on script renewal , copays etc .
I am interested in ARDX's use in the dialysis population and how fast they will try and transition some of these patients ...especially those on laxatives for constipation ...onto ARDX's drug X . Since it's already approved in Japan I suspect Nephrologists here will be watching how they implement its use over there.

I'm wondering about the EU ? That is a very large market .
Do you know when it will be approved there ?

The US dialysis population is now around 550K and about 400K of them have poorly controlled serum phosphorus levels which is a major concern for their MD's .
High serum phosphorus leads to calcification in arteries particularly coronary arteries and also makes patients prone to bone fractures .

Are you still in AUPH ?
NVS has just completed a major trial with Cosentyx for LN. Not sure when they will publish results but it's something you may want to watch for if you're still in that co.
Kiwi

[Watsonturtle]

Good Info. Agree with you ... ARDX looks strong. How long does a patient stay Ibsrela? I am assuming its less than 1 year as I recall seeing numbers that the annual cost per patient is about 12K? is that correct? WT

[Whalatane]

Diarrhea is the most common adverse event with starting ARDX's phosphorus lowering drug . However it should be noted that almost 40% of those on dialysis takes laxatives because many of the drugs etc they take cause constipation.
37% take stool softeners . These patients who are currently nowhere near goal on serum phosphorous levels will be the first to try ARDX's drug . To date no EU partner which leads me to speculate that this Co may be a buy out target for an EU based Co like CSL Vifor that already has a well established cardio- renal sales team.
JMO
Not investment advice
Kiwi

[Whalatane]

PDFA date is Oct 17th . Will IMHO be approved at least as a combo with the existing binders .
Existing binders cause constipation in many dialysis patients https://www.kireports.org/article/S2468-0249(19)31529-3/pdf so those that have this issue are probably the first to try Tenanapor as the most common AE is a looser stool with diarrhea a problem for some.
I expect them to start on a low dose and titrate as necessary .
If they can eventually get 20% of these patients onto Tenanapor thats about 100,000 patients in the US alone
Kiwi

[Whalatane]

Ibsrela scripts are very strong . Chk this twitter feed


MASi
@TOWiU2
·
2h
Replying to @TOWiU2 and @crypto_biotech
https://stocktwits.com/mailman1961/message/546206610
$ardx IBSRELA Prescriptions/Week

Week 80 = 22nd of September 2023:

Total scripts Trx. doubled since early Feb 23

-------------------
Kiwi

[Cosa]

Their last earnings the EPS was at (-$0.08) that's with Ibsrela alone. If Xphozah gets approved they could be positive by next year.

[Whalatane]

ARDX vs UNCY
ARDX may be suffering today because of the activity in UNCY ...full disclosure I have positions in both
Anyone on this board knows ARDX
UNCY has a competing ( or complimentary drug depending on your pt of view ) but has challenges with the FDA wanting more data and an Sec notice of non compliance with Naz listing rules ...ie trading under $1 for as long as it has.

FDA will give guidance to UNCY this fall ...ie Oct / Nov . Co is short in cash and this guidance will be do or die for the Co. .
If guidance from the FDA is favorable they will receive new funding and compete with ARDX in this market probably in 2025 ....
JMO
information only . Not investment advice
Kiwi

[Whalatane]

Cosa To GIA. ( go it alone ) is a huge / expensive undertaking .
Stock will probably drop if they announced that for X
So far they have not announced any partners for the EU. I suspect they will try and negotiate with CSL Vifor who already have a well established cardio-renal sales force operating there .
I'm hoping for a buyout before end of year
JMO
Kiwi

[Whalatane]

Ernie. re the FDA. The FDA approved Omonty for dialysis patients . My wife's Nephrology Dept thought their decision was rushed and decided to wait a year before using it . They wanted to see how the other dialysis clinics did with it .
For the first 20,000 treatments the drug worked fine ...then one patient went into shock and died from the drug .
Soon after two others also died in reaction to the drug .
FDA recalled the drug
Co that developed the drug went bankrupt.
So yeah ...let them ( the FDA ) take their time
Kiwi