Whalatane
1日前
Jefferies note ...via Frank on X
$ARDX Jefferies reiterated Ardelyx, Inc (ARDX) at a Buy rating and $11 price target.
-Mgmt is confident it can navigate the various Xphozah dynamics going into 2025 and are optimistic underlying patient demand should grow despite pot'l changes w/ Xphozah reimbursement. We'd also flag the CMS litigation is not completely over as mgmt will likely challenge / appeal imminently and there's still a scenario a PI / stay could happen by YE.
We appreciate there's still near term uncertainty but are confident stock can rebound once we're in 2025.
-Mgmt will move quickly to appeal the motion to dismiss...should hear more by YE. The Judge in ARDX's lawsuit against CMS recently granted a motion to dismiss though the case has not been closed. We think ARDX could file a "motion to reconsider" and point out specific flaws in the Judge's logic. The Judge could reconsider and grant a Pl or summary judgement, or if denied ARDX could appeal to the Circuit, which could possibly grant a stay before Jan 1st 2025 given the imminent irreparable harm. All in all, a Pl could still be possible before YE vs our initial belief that this is no longer on the table.
-The House and Senate bills continue to make steady progress in gaining co-sponsors and mgmt thinks a minibus/omnibus bill package could be possible as a vehicle for YE. HR5074 has gained bipartisan support in both the House and Senate and it's likely such a non-controversial bill could move forward before YE to "clear the deck" for a Republican House and Senate next year.
Also note that the initial bill for a bundling delay until 2033 was proposed by Republicans but Dems pushed for a much shorter 2 year delay. Thus, one could argue a Republican majority in the House/Senate could favor add'l bills in the future to delay bundling. ( my comment ...interesting )
-ARDX is also well-equipped and prepared to preserve volumes if Xphozah enters the bundle in 2025. Xphozah reps are out in the field messaging cont'd access and doctor feedback has mostly been (+). That said, docs need to actually go through the process themselves and importantly for substantially higher volumes to gain confidence Xphozah scripts will still be fulfilled.
Medicare scripts will be adjudicated by ARDX's existing patient assistance program Ardelyx Assist and filled at an external specialty pharmacy. Docs are already using the PAP in a small proportion of patients but key is that the PAP will need to be able to handle many thousands of scripts. The PAP has now been expanded in anticipation of greater volumes with all new staffers already hired, trained, and ready for Jan 1st, 2025, and external vendors are also ready to take on add'I patients.
It's also notable ARDX has continuity of care programs in place that will automatically enroll Medicare patients and provide free drug for 2 months....my emphasis ....good move
-Net net, mgmt is optimistic Xphozah won't face significant disruption in 2025 from a volume perspective though investors are understandably cautious.
Kiwi
Whalatane
2日前
Hi Free Most of my portfolio is AI related ...NVDA, VRT , VST etc I posted on Biotech Values board recently about APP ...which I assigned to my youngest son when it was $110 ...NEVER expecting its recent run .
Biotechs I like ...RZLT, OCUL , VERA, EWTX ,UNCY etc also had green days .
My feeling about ARDX . I think the Ceo will stick to his current position and wait to see if the Kidney Patient Act gets passed before the EOY. ...which might be a long shot
If it doesn't get enough cosponsors etc and it's pushed into next year ....hopefully he and CMS will negotiate and compromise .
My wife knows of patients on Xphozah who for the first time have been able to get their serum pho to goal . Never happened on the existing binders .
These are Medicare patients that will lose coverage starting Jan ...unless CMS and ARDX compromise ...OR the Kidney Patient act pass's.
I'm betting on an eventual compromise ...as explained in previous posts
Kiwi
Whalatane
3日前
RMB. I added this am
My take for what its worth
1) It will be tough to get the Kidney Patient Act passed before EOY . It needs to get added on to something like the Govt continued spending bill with more co sponsors . No impossible but a real challenge
2) DaVita and other dialysis centers are preparing for the shift to storing and dispensing Oral pho binders on site .
Some Nephrologists welcome this as it means they can be sure the patients get these meds . Currently there are problems with pharmacies filling only 1 mth at a time when the patient ask's for a 3 mth fill . If these meds can't be mail ordered the patient often miss's the 1 mth pharmacy pick up .
Dialysis center managers are less enthused ...big hassle for them to order , store , manage supplies .
3 ) For those on Medicare getting Xphozah ..... access to X may be very limited in Jan 2025 forward ...so some thoughts on prescribing Ibsrela instead as discussed in a previous post .
If so we should see an uptick in Ibsrela scripts in early 2025 ...although ARDX will be making less $ then if it were a Xphozah script ...even tho its the same drug
4) Ibsrela scripts for dialysis patients who don't have IBSC would obviously be an off label script . While this practice ( writing off label scripts ) may be frowned on ...it's not uncommon. ( I had an off label script for Vascepa before the R-IT approval for the CAD indication )
5 ) Theres going to be pressure from Nephrologists and patients for a compromise to be worked out here .
Some patients are now able to get their serum pho levels to goal on Xphozah ...where as they couldn't previously on the existing binders .
ARDX can lower the price of Xphozah to be similar to price per gm of Ibsrela in exchange for a longer runway before having to compete with generics
Currently its 2 yrs in TDAPA , then 3 yrs of price adjustment , then compete with generics
They can adjust that to something like 2 yrs in TDAPA , then 6 yrs in gradual price adjustments , then compete with generics
Just my thoughts ...we'll see how they age :--)
Kiwi
Whalatane
6日前
Big bet by an insider ...open market purchase David M Mott
http://archive.fast-edgar.com/20241114/AWZZ3Q2COZ22UZ3Z2C9N2ZZ2P4KUZ22IZY62/
David M. Mott is a prominent figure in the biotech investment landscape, with a long and successful career spanning over three decades. Here's an overview of his biotech investments and career:
Investment Career
David Mott is currently a private investor through Mott Family Capital12. Prior to this, he served as a General Partner at New Enterprise Associates (NEA) from 2008 to 2020, where he led the healthcare investing practice25. During his time at NEA, Mott oversaw $1 billion in health care venture capital8.
Board Positions
Mott holds several chairman positions in biotech companies:
Chairman of Adaptimmune since January 20174
Chairman of Ardelyx, Inc. since 200812
Chairman of Mersana Therapeutics since 201312
Chairman of Novavax, Inc. since June 20202
He previously served as chairman for Epizyme and Imara, Inc.12
Notable Investments
Throughout his career, Mott has been involved in numerous biotech investments, including:
Sagimet Biosciences
Cydan
Nightstar Therapeutics
Vtesse
XTuit Pharmaceuticals
Clementia Pharmaceuticals3
Industry Experience
Before his investing career, Mott held executive positions at MedImmune:
President and Chief Executive Officer from 2000 to 2008
Various roles including Chief Operating Officer and Chief Financial Officer from 1992 to 200012
During his tenure at MedImmune, Mott led the sale of the company to AstraZeneca in June 2007 for $15.6 billion1.
Investment Impact
Mott's expertise in the biotech sector has led to significant achievements:
Involved in more than $40 billion in corporate acquisitions, fundraising, and partnerships
Supported over 35 initial public offerings or corporate acquisitions
Brought more than a dozen new drugs through development to commercialization
Served on 25 corporate boards1
David Mott's extensive experience and successful track record have established him as a key figure in biotech investing, with a particular focus on venture capital and growth equity investments in the healthcare sector.
Kiwi
Whalatane
2週前
Also beginning Jan. 1, 2025, the bundled payment will include oral-only renal dialysis drugs and biologics — a move initially set to begin in 2014 but delayed until now by several laws and court challenges.
“In response to comments that we received on the proposed rule [released in July], we are finalizing a policy to pay the [transitional drug add-on payment adjustment] for phosphate binders based on 100% of the average sales price, increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a [transitional drug add-on payment adjustment] payment for phosphate binders. We expect that incorporating oral-only drugs and biological products into the [End-stage Renal Disease Prospective Payment System] will increase access to these drugs,” CMS stated in the release.
In a response statement, Kidney Care Partners (KPC), a non-profit coalition of stakeholder organizations, expressed concern that “the base rate is insufficient to support adding new treatment options without adding new money.”
“We applaud CMS’s efforts both in recognizing that providing oral-only medications as part of the bundle requires additional funding, as well as creating access for AKI patients to home dialysis,” Mahesh Krishnan, MD, MPH, MBA, chair of Kidney Care Partners, said in the statement. “However, KCP has consistently raised concerns that significant changes are needed to the ESRD PPS system to maintain an appropriate level of care, access and reimbursement for the more than 557,000 Americans who rely on regular dialysis treatment.”
KPC urged support of the Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S. 4469) to provide a permanent reimbursement pathway for innovative drugs and devices.
Kiwi
ErnieBilco
2週前
Ardelyx (NASDAQ:ARDX) plunged 17% after a court dismissed a lawsuit the company filed against the Centers for Medicare and Medicaid Services (CMS) over its proposal to bundle its kidney disease therapy Xphozah in the Medicare payment system applicable for dialysis services.
"Defendants’ motion to dismiss is therefore granted, and plaintiffs’ motion for a preliminary injunction or expedited summary judgment is denied as moot," US District Judge Beryl Howell wrote in an opinion.
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In October, the FDA approved Xphozah as a late-line add-on therapy to cut serum phosphorus in adults with chronic kidney disease on dialysis.
The issue relates to Medicare’s plan to include Xphozah, along with all other oral-only phosphate-lowering therapies (PLTs), in its End-Stage Renal Disease Prospective Payment System (ESRD PPS), a bundled payment system for dialysis services.
Ardelyx (ARDX) didn't immediately respond to Seeking Alpha email request for comment.
The decision, which will take effect on January 1, 2025, can potentially eliminate Part D coverage for Xphozah.
The plaintiffs alleged that the Medicare proposal violates U.S. law, noting that dialysis providers do not administer Xphozah and other PLTs, currently offered under outpatient pharmacy benefit plans such as Medicare Part D.