Category: ARDX

Ardelyx, Inc. (NASDAQ:ARDX) Q1 2023 Results Earnings Conference Call May 4, 2023 4:30 PM ET

Company Participants

Caitlin Lowie – Vice President, Corporate Communications and Investor Relations

Mike Raab – President and Chief Executive Officer

Susan Rodriguez – Chief Commercial Officer

Justin Renz – Chief Financial and Operations Officer

Conference Call Participants

Yigal Nochomovitz – Citi Research

Laura Chico – Wedbush Securities

Joseph Thome – TD Cowen

Christopher Raymond – Piper Sandler & Co.

Matthew Kaplan – Ladenburg Thalmann

Operator

Good day. And welcome to the Ardelyx First Quarter 2023 Conference Call. All participants will be in listen-only mode. [Operator Instructions]. Please note this event is being recorded.

I would now like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations. Please go ahead.

Caitlin Lowie

Thank you. Good afternoon, everyone, and welcome to our first quarter financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the company’s website at ardelyx.com.

During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review our risk factors in our most recent quarterly report on Form 10-Q filed today, which can also be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so even if our views change.

Our President and CEO, Mike Raab, will begin today’s call with opening remarks and an overview of the company’s progress during the first quarter of 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the launch of IBSRELA.

Justin Renz, Chief Financial and Operations Officer, will conclude today’s formal remarks with a review of the company’s financial performance during the first quarter ended March 31st, 2023 before we open the call to questions.

With that, let me pass the call over to Mike.

Mike Raab

Thank you, Caitlin. And good afternoon, everyone. I’m excited to be here today to highlight the momentum we’ve created at Ardelyx as we report another quarter of consistent growth for IBSRELA and the progress we’ve made on our path to bring XPHOZAH to patients.

In this afternoon’s press release, we also announced a recent business development transaction designed to bring our novel mechanism products to patients and strengthen our cash position.

What you are seeing from Ardelyx is a focus on execution. We know our priorities and the team continues to deliver. Notably, IBSRELA sales came in at $11.4 million, an increase of 31% over the fourth quarter of last year, and all indicators continue to reinforce our confidence that we are on track for IBSRELA to become an important product for patients with IBS-C. In a moment, Susan will share details on our momentum and learnings as we are now just over a year into launch.

As we guided during our Q4 earnings call in March, we resubmitted the NDA for XPHOZAH on April 17, and await the goal review date from the FDA which we expect mid-month. We’re now in full preparation mode for a launch in the second half of this year pending approval of the NDA.

Comprehensive nephrology research conducted in the first quarter reflects a high level of awareness, interest and intent to adopt XPHOZAH, and we anticipate a strong response to the product launch. Our commercial team, led by Susan, is focused on executing a plan that will capitalize on the highly recognized unmet needs in the treatment of hyperphosphatemia and a strong nephrology interest in adopting a novel mechanism therapy as we plan for long term success of XPHOZAH. We will share information on our go-to-market strategy as we get closer to launch.

Finally, we continue to be thoughtful about how we fund the company. We’re excited about the collaboration agreement with METiS Therapeutics to develop one of our earlier stage assets, our portfolio of TGR5 agonist compounds. We received an upfront payment of $750,000 In April following the signing of the agreement and have potential to receive additional milestone payments and royalties in the future.

As we look ahead to the rest of the year, we will continue to focus on execution. We are encouraged by our progress to date and the responses we hear from the market.

Now, let me hand it over to Susan who will share more detail about the commercial performance of IBSRELA. Susan?

Susan Rodriguez

Thank you, Mike. The first quarter of 2023 marked one year since the launch of IBSRELA. We launched in a market that many thought was impenetrable for new entrants, with an innovative strategy few had seen. After 12 short months, our strategy is continuing to drive uptake, and we are increasingly gaining share in the IBS-C market.

In the first quarter of this year, total net sales for IBSRELA came in at $11.4 million, reflecting a 31% increase over the fourth quarter of 2022. The drivers fueling this growth are strong and persistent, which we believe point towards continued growth for IBSRELA as we see new and refill prescriptions growing in parallel to persistent growth in both new and repeat writers.

To further characterize the key growth drivers to our IBSRELA business, I’m going to briefly review the highlights of our disruptive commercial strategy and how we are performing against these key components of the plan.

First and foremost, Ardelyx is a company that discovers, develops and commercializes first-in-class novel therapies to address important unmet medical needs. Physicians are choosing IBSRELA as a result of a recognized unmet need in IBS-C. Patients are responding well to IBSRELA and staying on treatment.

The differentiated product profile, with a novel mechanism of action, and clinical data supporting IBSRELA’s safety and efficacy resonate with the GI community. We continue to generate clinical insights with additional analyses being presented at the Annual Digestive Disease Week that will kick off Saturday in Chicago, which we expect will continue to fuel this favorable view of the IBSRELA products and clinical profile.

Second, the unmet medical need in IBS-C is significant and persistent. Patient market research indicates that approximately 77% of patients with IBS-C continue to experience residual symptoms despite treatment with prescription therapy. As our launch progresses, physicians are gaining firsthand experience with IBSRELA, and the favorable results they have seen from the initial patients they’ve treated with IBSRELA is driving an expanded view of the patients across their practice, who they believe could benefit from the novel mechanism treatment approach provided by IBSRELA.

Third, we are executing with IBSRELA by targeting a concentrated set of specialist healthcare providers that exist within what is now an established IBS-C prescription market. These top writing HCPs see patients with IBS-C every single day and commonly see that their patients continue to suffer with symptoms despite treatment with GCC agonist therapies.

These HCPs have a strong interest in learning about IBSRELA and are continuously engaging with our sales force. They have established processes in place to pursue and secure the prior authorizations required for IBSRELA and are helping to ensure that patients gain access to IBSRELA therapy.

And lastly, our payer strategy is uniquely designed to address the access dynamics implicit to a novel branded entrant launching into a market where patients are commonly treated with established therapies, yet persist with important unmet medical needs.

Early in our launch, commercial and government payers evaluated IBSRELA and established coverage policies that grant access on the basis that a patient has been treated with, in most cases, a GCC agonist. Since the patients prescribed IBSRELA are already considered by their HCP to be insufficiently treated despite GCC agonist treatment, offices are motivated to administer the prior authorizations, which demonstrate that patients meet the coverage criteria. As a result, approval rates are favorable and patients are gaining access to IBSRELA.

This favorable access landscape experienced by treating HCPs is further reinforcing expanded use for those patients and their practice in need of a novel approach. Due to the limited prescription options available to treat IBS-C and the unmet need despite use of these existing options, coverage policies include a path for use of IBSRELA with prior authorization approvals achievable.

Since our access strategy centers on proper patient selection and support of prior authorization procedures, we are achieving access via HCP demand, and not by unnecessary rebaiting to payers, resulting in a favorable dynamic for the gross to net profile of IBSRELA.

Combined, these core elements of our strategy centered on targeting, positioning and access are working together and IBSRELA is increasingly making an impact on the IBS-C market at a price point aligned to its clinical value proposition.

All of the uptake indicators continue to give us confidence that IBSRELA can achieve a mid to high-single digit peak market share position, which at IBSRELA’s price point in this 5 million annual IBS-C prescription market would make Israel a $500 million product at peak with the potential to exceed this level with additional market share gains.

As I look ahead to the launch of XPHOZAH, the market dynamics in the hyperphosphatemia space are similar to the dynamics in IBS-C, an established prescription market, a concentrated group of prescribers, existing treatment options limited to one class of therapy, and patients that despite treatment are in need of a novel mechanism treatment approach.

The unique clinical value proposition of XPHOZAH points to the same key strategic go-to-market elements in the areas of targeting, positioning, access and pricing that Ardelyx has successfully executed with the launch of IBSRELA and preparations are well underway.

I look forward to sharing more of those details as well as updates on our continued progress with IBSRELA in the months ahead.

Before I hand it to Justin, I would like to highlight that I am incredibly proud of the highly experienced, high performing team who is behind IBSRELA’s disruptive commercial strategy and our success. Together, we are realizing the vision of our Ardelyx.

Justin?

Justin Renz

Thank you, Susan. I’m going to walk you through our product sales, collaboration revenue and expenses before turning to our cash position and how we’re thinking about 2023.

As both Mike and Susan mentioned, we had net product sales of IBSRELA in the first quarter of $11.4 million, reflecting significant quarter-over-quarter growth, a 31% increase from what was reported in fourth quarter sales.

It was in the first quarter of last year that we recognized our initial sales of IBSRELA of $0.5 million dollars and we had $27 million in cumulative net product sales in our first four quarters since launch.

Research and development expenses were $9.1 million for the quarter ended March 31, 2023, reflecting a slight increase over $8.9 million from the same quarter last year.

Selling, general and administrative expenses were $26.8 million in the first quarter of 2023, an increase of $7.5 million compared to $19.3 million in the same period of 2022. The increase was primarily due to the increased costs associated with the continued commercialization and growth of IBSRELA.

For the quarter ended March 31, 2023, we had a net loss of approximately $26.8 million or $0.13 per fully diluted share compared to a net loss of $28.1 million or $0.21 per share in the first quarter of 2022.

It is notable that our net loss for the first quarter included over $4 million of non-cash items, including share-based compensation expense of $2.9 million, interest expense related to the sale of future royalties of $1 million and an impairment of a lease right of use asset of approximately $429,000.

As of March 31, 2023, we had total cash, cash equivalents and short term investments of $130.4 million as compared to $123.9 million at year-end 2022.

I will take a minute to walk through our cash flows for the quarter. As I said, we ended 2022 with approximately $124 million in cash. We then raised $51.9 million during the quarter through sales of our common stock under our ATM program, $20 million of which we announced on our March 2 conference call when we reported our fourth quarter results, and another $31.9 million from sales during the period from March 7 through March 27.

To note, in the first quarter, we spent approximately $20 million, including inventory build, preparing for the launch of XPHOZAH and to support IBSRELA growth. Our net loss and working capital adjustments accounted for the remaining $25 million in operating cash burn.

Regarding our spending requirements for the remainder of 2023, we will continue to invest in the launch of XPHOZAH in the near term as we approach the goal review date. Besides the further investments in supply, we will be expanding our commercial footprint as well as adding additional promotional spend to support the launch activities.

In terms of financing the company, as Mike mentioned, we announced the licensing agreement with METiS Therapeutics, under which METiS has exclusive rights to develop and commercialize our TGR5 agonist compounds, all therapeutic areas. This agreement brings opportunities to develop one of our next generation technologies. And as part of the agreement, we received an upfront payment of $750,000 from METiS in April. We have the potential for substantial clinical, regulatory and commercial milestones, as well as future product royalties.

We will continue to strengthen our cash position by looking at all options available to us, including more non-equity solutions. We will make thoughtful decisions that maximize shareholder value.

We are confident in our ability to continue to fund our operations.

I will now turn the call back to Mike for some concluding comments. Mike?

Mike Raab

Thanks, Justin. As you heard from Susan and Justin, our performance reflects a focus on executing on our plans. We know that we have more to do in the months ahead. And I’m confident that the team at Ardelyx is prepared and capable of delivering on the plans and admissions that we collectively share. I look forward to keeping you updated on our continued progress.

With that, I will now turn the call to questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions]. Our first question comes from Yigal Nochomovitz from Citigroup.

Yigal Nochomovitz

Just can you help us a little bit with the math for IBSRELA for the first quarter? We were looking at the Symphony data. I don’t know how accurate that is. But in any case, we did some math on that using the just over 12,000 scripts and then the WACC, which I know increased on February 1, and the using the gross-to-net from last year of 28%, you were getting a little bit of a higher number. So could you just comment as to what the actual gross-to-net was in the first quarter and any other dynamics that was driving the overall revenue picture?

Mike Raab

Let me actually ask Susan to speak first to where we stand with IQVIA and Symphony as those data begin to mature and then ask Justin speak to gross-to-net.

Susan Rodriguez

As we track both IQVIA and Symphony scripts, what we’re finding is that the growth trajectories are actually quite comparable. So, directionally, it’s a good indicator on the momentum we’re seeing with IBSRELA uptake. Symphony, based on their projection methodology, consistently reports a slightly higher level of scripts. So I think that probably explains why maybe your math is slightly different than what we have announced as our quarterly performance for Q1 2023.

Yigal Nochomovitz

Can you just give the rough delta? Like, what’s the inflation with Symphony? Do you have a rough number for that? Well, how much is [indiscernible] relative to what is more accurate?

Susan Rodriguez

I really can’t comment on that because I think in terms of – we need a few more months of accumulating this audit data to really make a determination on which is the most accurate reflection. So, I just need a few more months for me to be able to answer that question, Yigal.

Mike Raab

I think as we’ve been saying consistently is that we know that neither one of the two are going to be perfectly covering some of the direct accounts that we have with specialty pharmacies. I think what we said is, it’s going to be 12 to 15 months, thereabouts, before we believe that we’ll be comfortable with projections there. And we will do our best to provide you what that delta looks like. But I think we’re in a position right now that it’s not going to be a perfect number, so we want to get a little bit better.

Justin, you want to address the gross-to-net?

Justin Renz

This is, as you know, the first time we had sales in the beginning part of the calendar year. So, it’s very important for us to make sure that we have access available to all of our patients who want to have IBSRELA prescribed to them. And so, our gross-to-net profile is affected by the commercial copay, other access availabilities for our patients. And so, in the first quarter, as you know, when copays reset whether they’re a private payer, commercial payer, or government payer, there’s more of a rebate possibility. Rebate is not the right word. A copay buydown, if you will, we make available. And so, we expect that to decline over the course of calendar 2023. So our gross-to-net, which is published in our external financials for Q1, was 33.7, will continue to decline over the course of the year. And we expect, to your point, it should go to the higher 20 range by the end of the year.

Mike Raab

Yigal, if you look back over the last 10 years, the first quarter certainly has had seasonality for the IBS-C space, and obviously early for us, but we didn’t suffer that same seasonality in the results that we saw. So we feel good that we’re on the right track. But we’ll get more insight on those numbers and provide you that guidance when we’re ready to.

Yigal Nochomovitz

I know you probably can’t answer this because you don’t know yet, but do you have any better feeling yet as to whether – for hyperphosphatemia whether you’re going to go down the two or the six month review clock? Or is it sort of the same?

Mike Raab

I think as we’ve said consistently, our base case is the six month review. We will all know we expect by mid-month, and we’ll certainly announce that. But I think we should all have the expectation that it’d be a six month review. It’d be nice to be surprised, but that’s our base case.

Operator

Our next question comes from Laura Chico from Wedbush.

Laura Chico

I’ve got two for you, I guess. First on IBSRELA, can you expand your comments a little bit on the prescribing breadth? And I guess, what metrics should we be watching for to gauge how this might be changing in terms of repeat usage among prescribers? The reason I ask is, I think your market research has shown about 50% hold favorable perceptions of the drug once they use it. So, trying to understand how that’s translating to repeat utilization. And then I have one follow-up.

Susan Rodriguez

I think if you look at – ultimately, we’ll be able to give you better direction when we give guidance on tracking new writers and then repeat writers. And we’re seeing a very consistent relationship of repeat writing over the last several months as we build momentum for IBSRELA. And for now, I think really seeing as well the new and refill Rx ratio is also extremely encouraging in terms of the growth we’re seeing at both levels. So patients are persisting on therapy, which is a further reflection of the favorable experience physicians are having and why we are seeing repeat writing.

Mike Raab

Laura, just anecdotally, we’re all getting out in the field now with the commercial organization. And the anecdotal stories I hear from physicians and caregivers is that – and it’s been tried on the most difficult to treat patients, which is a normal tendency with a new drug with a new mechanism getting launched, and they’re finding it to be what we’ve anticipated it would be, that they’re getting a great response. And that begins to then help them say, gee, how many other patients deserve the right to try new mechanism and that’s beginning to gain traction.

Laura Chico

I guess then, one follow-up on XPHOZAH. Can you just comment there too on incent to prescribe dynamic and how that’s changed over time because this is another one where you’ve had market research data going back for some time. Now that we’re getting closer here, just curious, I think the last metric I’d seen was around the mid-50s in terms of the percent of surveyed physicians that plan to use XPHOZAH in the first three months. How has it changed over time, gets higher or lower, any commentary there?

Susan Rodriguez

Laura, actually, we just completed comprehensive quantitative research on XPHOZAH the first quarter of 2023. And what we found is that all of those metrics are really quite comparable. So the market dynamics continue to indicate high level of unmet need, high level of awareness of XPHOZAH, and that intend to adopt number that you referenced is really quite comparable in the research that we just conducted.

Operator

The next question comes from Joseph Thome from TD Cowen.

Joseph Thome

Maybe the first one, I know when the process was sort of – the appeal was granted, the OND directed the division to work with you on a label, I guess have any of those communications happened pre the submission? Or is that part of the review process and kind of none of that has happened yet. And when you think about a potential label, what’s sort of the scenario that you’re anticipating?

Mike Raab

I think if you think about Peter Stein’s letter where he said, appeal granted, basically says that the drug should have been approved. We were, as you recall, well in the process of negotiating package insert back when we received the CRL. And in Peter’s letter, he talked about how this would maybe be appropriate and instructed the division work with us on labeling where you had binders that no longer were – that were inadequately controlled or tolerated, which is likely to be from a reimbursement standpoint where we would end up anyway. But it strengthens the position and the arguments with insurers to get the [indiscernible].

It’s radio silence from the FDA until we get the goal date. So there have not been conversations with them. We would anticipate that those begin subsequently as we get closer to whatever, it’s a six month or a two month review, which, as I said, we expect six.

Joseph Thome

Just as we think about the cadence of a potential launch, should we think of it similarly as what IBSRELA has done over the past kind of four quarters here? Or is there any reason why XPHOZAH, the uptake would be faster or slower for any reason. Kind of how should we think about that cadence?

Mike Raab

I think it’s a bit early for that. We certainly will get to a place around launch where we can give some perspective on that. We’re not going to guide at this stage, just like we aren’t with IBSRELA, until we get some experience under our feet. As we just spoke about the anticipation for XPHOZAH has not tempered even with his two year delay, so we anticipate it’s going to be well received and the commercial footprint that we’ll put in place is going to be appropriate to make sure that we have feet in front of those 8,000 physicians who are going to make those prescribing decisions.

Operator

The next question comes from Chris Raymond from Piper Sandler.

Christopher Raymond

I’ve got a couple. Maybe for Susan first, I know you guys have described a scenario of taking share, despite the typical patients being on existing therapy, but I wonder if you can maybe give a little bit more color on the prototypical patient that’s new to therapy, and maybe how that’s changed since launch and how you sort of aspire to see that maybe over the next year or so. And I guess what I’m asking specifically is just when or if you would expect to start to see any sort of frontline use or at least demand or expectations from docs.

And then the second question, I guess, on IBSRELA, I know you guys indicated you’re seeing persistency of therapy, but just any sense of average duration on therapy and how that might shake out over time?

Mike Raab

Let me make a couple of comments and then Susan, please. I think the thing that’s important to note, and we talk about this with physicians all the time, our 1,200 patients were naive to therapy. There were maybe 50, thereabouts who had had previous exposure to GCC agonist. So it’s a frontline therapy clinical study that we got approved for IBSRELA. So that’s an important backstop to think about.

The realities of reimbursement is that no matter what we do, the likelihood of payers saying, hey, you’ve got to fail something else is likely going to be there. That doesn’t mean that there isn’t interest out there for using patients, but it’s a harder hurdle. Susan?

Susan Rodriguez

Yes. It’s really important to note, Chris, following up on my comments that the – when you go and talk to physicians based on the product profile of IBSRELA and the clinical data, they see it as a drug that’s quite broadly applicable to patients and are very, very pleased with how it’s performing. However, the market structure is such that actual first line use before a GCC agonist is something that is a challenge to secure access for the patient.

But what we’re finding, keep in mind with our go-to-market strategy, concentrated on the high writing doctors, these high writing doctors, in many cases, when the patient comes to them, they’re on GCC agonist therapy. So what we’re finding is that, on a daily basis, these physicians are seeing their patients who have been tried on these – there’s limited options. It’s either Linzess or Trulance, and are persisting in their symptoms.

So what we’re finding is that their expanded use is really centered on – now that they have – there is another option, they’re familiar with it, their experience with it has been favorable, they’re starting to actually bring this up, raise it, discuss it with their patients, get into more of a discussion around their symptomology, letting them know there’s a new option, and would they like to try it. So, there is a nice opportunity for us to continue to expand use across the patients that they see daily, who already implicitly meet the criteria of having tried on a GCC agonist.

Mike Raab

Chris, I would note with that is – with what Susan just said is, if you look at the numbers that she said that we anticipate, and there certainly may be upside to it for peak revenue, that doesn’t contemplate frontline. That is just those patients who are not getting the relief and improvement on GCC agonist. So that’s an important thing to keep in mind.

Christopher Raymond

And maybe on XPHOZAH, and this might be maybe an unfair question and one you might not want to answer or really have a sense of, but, Mike, you’ve said pretty clearly that you guys were in labeling discussions a couple of years ago when FDA sort of reversed field on this. Are you guys anticipating in your planning any major differences in labeling now versus what you thought you were going to have in hand two years ago?

Mike Raab

Major differences as I think I said in my comments is that we’re likely to be with some languages – our guesstimate is that after binders are ineffective or intolerable, which we know ends up being 80% of patients on binder therapy. And that’s likely what we would have ended up from a payer perspective, regardless. And that’s somewhat reflected in, as we shared, the appeal granted letter that we got from Dr. Stein. So I think that’s what we would say that we would anticipate the label to be reflecting.

Operator

[Operator Instructions]. Our next question comes from Matt Kaplan from Ladenburg Thalmann.

Matthew Kaplan

Congrats on the IBSRELA results for the quarter. Just going back to XPHOZAH, can you give us a sense in terms of the launch prep and where you are with that? And specifically, what the commercial footprint and how it will change from what you have currently for IBSRELA to adding in XPHOZAH and what that commercial footprint will look like?

Mike Raab

Yeah. And we certainly will get into much more specificity on that, Matt, as we get closer. But, Susan, you want to provide some sort of general comments on that, would be great.

Susan Rodriguez

We are mobilizing preparedness to launch XPHOZAH with our very strongly established marketing, patient services, distribution, access, payer engagement, commercial operation that is already in place and proven and successful with IBSRELA. So we are well on our way to preparing for the launch.

And in terms of expanding the commercial footprint to access those 8,000 nephrologists that comprise the majority of the hyperphosphatemia scripts, as we get closer to understanding our PDUFA date, we would expand our commercial footprint to be able to access those doctors.

And really, our whole management team is quite steeped in the renal space and nephrology experience, quite networked across the country and we’re confident that we’re going to be able to mobilize and put those feet out on the street quickly once we have a better understanding on the actual launch date. The rest of the launch planning is well underway.

Mike Raab

As you can imagine, Matt, with what we’re doing on IBSRELA and Susan was reflecting on there is much of that infrastructure that’s requisite for a successful launch exists. So we’re not rebuilding that at all. We don’t have to build that from scratch. And it’s the feet on the street that’s been a major investment that we make as we get closer to the PDUFA today.

Matthew Kaplan

That really hasn’t occurred yet this year. It’s really kind of a second half of the year situation.

Mike Raab

That’s correct.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Ardelyx President and CEO, Mike Raab, for closing remarks.

Mike Raab

Thanks again for the question, everyone, who joined today’s call. I look forward to updating you when we receive the goal date review for XPHOZAH over the next few months, sharing the details of how Susan and the team will leverage our commercial strategy that is proving successful for IBSRELA, to continue to drive growth of IBSRELA and bring XPHOZAH to patients following approval.

Once again, I want to thank team Ardelyx for your commitment and dedication to our patients and to the physicians and patient communities who have continued to support Ardelyx along our journey. We look forward to sharing more in the weeks and months ahead.

With that, we can close the call. Thank you, operator.

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/94035

New York, New York–(Newsfile Corp. – August 21, 2021) – WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Ardelyx, Inc. (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”) of the important September 28, 2021 lead plaintiff deadline.

SO WHAT: If you purchased Ardelyx securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 28, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made materially false and misleading statements regarding Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with chronic kidney disease (“CKD”) on dialysis and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”). Specifically, the lawsuit alleges that defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93899

New York, New York–(Newsfile Corp. – August 19, 2021) – The Law Offices of Vincent Wong announce that a class action lawsuit has commenced in the on behalf of investors who purchased Ardelyx, Inc. (“Ardelyx”) (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021.

If you suffered a loss, contact us at the link below. There is no cost or obligation to you.
https://www.wongesq.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18739&wire=5

Allegations against ARDX include that the Company made materially false and/or misleading statements and/or failed to disclose that: 1) the Company overstated the likelihood that tenapanor would be approved by the Food and Drug Administration (“FDA”); and 2) Defendants possessed, were in control over, and as a result, knew that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely that the FDA would not approve the drug.

If you suffered a loss in Ardelyx you have until September 28, 2021 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

Vincent Wong, Esq. is an experienced attorney that has represented investors in securities litigations involving financial fraud and violations of shareholder rights. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Vincent Wong, Esq.
39 East Broadway
Suite 304
New York, NY 10002
Tel. 212.425.1140
Fax. 866.699.3880
E-Mail: vw@wongesq.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93814

New York, New York–(Newsfile Corp. – August 17, 2021) – The following statement is being issued by Levi & Korsinsky, LLP:

To: All persons or entities who purchased or otherwise acquired securities of Ardelyx, Inc. (“Ardelyx”) (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Northern District of California. To get more information go to:

https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18652&wire=5

or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500. There is no cost or obligation to you.

Ardelyx, Inc. NEWS – ARDX NEWS

CASE DETAILS: According to the filed complaint: 1) the Company overstated the likelihood that tenapanor would be approved by the Food and Drug Administration (“FDA”); and 2) Defendants possessed, were in control over, and as a result, knew that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely that the FDA would not approve the drug.

WHAT THIS MEANS TO SHAREHOLDERS: If you suffered a loss in Ardelyx, you have until September 28, 2021 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

NO COST TO YOU: If you purchased Ardelyx securities between August 6, 2020 and July 19, 2021, you may be entitled to compensation without payment of any out-of-pocket costs or fees.

PROTECT YOUR FINANCIAL INTERESTS: Complete this brief submission form https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18652&wire=5 or call 212-363-7500 to discuss the case with Joseph E. Levi, Esq.

WHY LEVI & KORSINSKY: Levi & Korsinsky have a proven track record of winning cases worth hundreds of millions of dollars for shareholders over a 20-year period. We represent and fight for shareholders who have been wronged by corporations.

Levi & Korsinsky is a nationally recognized firm with offices in New York, California, Connecticut, and Washington, D.C. The Firm’s Founding Partners, Joseph Levi and Eduard Korsinsky, have been representing shareholders and institutional clients for almost 20 years and have achieved remarkable results for clients in the U.S. and internationally. The firm, with more than 80 employees, is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion for employees and those that we represent. Our attorneys have extensive expertise representing investors in securities litigation with a track record of recovering hundreds of millions of dollars in cases. Levi & Korsinsky was ranked in Institutional Shareholder Services’ (“ISS”) SCAS Top 50 Report for 7 years in a row as a top securities litigation firm in the United States. The SCAS Top 50 Report identifies the top plaintiffs’ securities law firms in the country, and year after year, ISS has recognized Levi & Korsinsky as a leading firm in the area of securities class action litigation.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
55 Broadway, 10th Floor
New York, NY 10006
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
www.zlk.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93537

New York, New York–(Newsfile Corp. – August 17, 2021) –  Pomerantz LLP announces that a class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of its officers. The class action was filed in the United States District Court for the Northern District of California, Oakland Division, and docketed under 21-cv-06228. Plaintiff brings this federal securities class action under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder, 17 C.F.R. § 240.10b-5, on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”), and who were damaged thereby (the “Class”).

If you are a shareholder who purchased or otherwise acquired Ardelyx securities during the Class Period, you have until September 28, 2021 to ask the Court to appoint you as Lead Plaintiff for the Class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class medicine to improve treatment for people with cardiorenal disease. This includes patients with chronic kidney disease (“CKD”) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia; and CKD patients and/or heart failure patients with elevated serum potassium, or hyperkalemia.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”). Defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support a New Drug Application (“NDA”) for tenapanor was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug.

In June 2020, Defendants submitted an NDA to the FDA for Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis. According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3,” resulting in the “tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.” If approved, tenapanor “would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake[,]” and “could greatly improve patient adherence and compliance with one single pill dosed twice daily in contrast to current therapies where typically multiple pills are taken before every meal.” Thus, tenapanor (and its promise) was widely touted by Defendants and, accordingly, extremely important to the valuation (and future success) of Ardelyx securities.

The FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act (“PDUFA”) date of April 29, 2021.

The Company repeatedly lauded this development, highlighting the FDA’s acceptance and review of the NDA, supported by so-called “successful” Phase 3 studies, in each subsequently filed quarterly report and in the Company’s 2020 annual report. Even when the FDA requested that the Company provide additional information related to Ardelyx’s clinical data, which caused the PDUFA date to slip by three months, Defendants continued to hype Ardelyx’s “positive” clinical trial results, which, according to them, showed “improvements” over current treatments, supported tenapanor’s “clinical safety and efficacy,” and reinforced its “potential” as a “transformative” treatment. At no point did Defendants state (much less suggest) that there may be fatal issues with the drug, its clinical trial data, or both. Rather, Defendants simply claimed that the FDA’s request was merely because they needed help to “better understand the clinical data in light of tenapanor’s novel mechanism of action as compared to approved therapies.”

Defendants’ rosy narrative, however, came to a halt after the market closed on July 19, 2021. At that time, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, that said the administration had found deficiencies that precluded discussion around the would-be labeling and post-marketing requirements for tenapanor. Critically, the FDA said it detected issues with both the size and clinical relevance of the drug’s treatment effect.

Immediately, analysts cut their price targets and downgraded the Company’s rating. Piper Sandler, for example, rated Ardelyx neutral (down from a buy-equivalent rating) and wrote, “we struggle to see a path forward for Tenapanor.” Raymond James, another analyst, reset the Company’s price target to $4.00 from $14.00 per share.

The Company’s share price likewise plummeted, falling $5.69 per share, or nearly 74%, in a single day, to close at $2.01 per share on July 20, 2021, before falling another 4.2% by market close on July 21, 2021.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93487

Ardelyx (ARDX Quick QuoteARDX – Free Report) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to loss of $0.28 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -25%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.32 per share when it actually produced a loss of $0.34, delivering a surprise of -6.25%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

Ardelyx, which belongs to the Zacks Medical – Drugs industry, posted revenues of $1.31 million for the quarter ended June 2021, surpassing the Zacks Consensus Estimate by 19.36%. This compares to year-ago revenues of $1.84 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock’s immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management’s commentary on the earnings call.

Ardelyx shares have lost about 76.5% since the beginning of the year versus the S&P 500’s gain of 18.8%.

What’s Next for Ardelyx?

While Ardelyx has underperformed the market so far this year, the question that comes to investors’ minds is: what’s next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company’s earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Ardelyx was mixed. While the magnitude and direction of estimate revisions could change following the company’s just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.29 on $1.1 million in revenues for the coming quarter and -$1.32 on $8.79 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical – Drugs is currently in the bottom 17% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

NEW YORK, Aug. 12, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of its officers.   The class action was filed in the United States District Court for the Northern District of California, Oakland Division, and docketed under 21-cv-06228.  Plaintiff brings this federal securities class action under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder, 17 C.F.R. § 240.10b-5, on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”), and who were damaged thereby (the “Class”).

If you are a shareholder who purchased or otherwise acquired Ardelyx securities during the Class Period, you have until September 28, 2021 to ask the Court to appoint you as Lead Plaintiff for the Class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980.  Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class medicine to improve treatment for people with cardiorenal disease.  This includes patients with chronic kidney disease (“CKD”) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia; and CKD patients and/or heart failure patients with elevated serum potassium, or hyperkalemia.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”).  Defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support a New Drug Application (“NDA”) for tenapanor was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug.

In June 2020, Defendants submitted an NDA to the FDA for Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis.  According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3,” resulting in the “tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.”  If approved, tenapanor “would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake[,]” and “could greatly improve patient adherence and compliance with one single pill dosed twice daily in contrast to current therapies where typically multiple pills are taken before every meal.”  Thus, tenapanor (and its promise) was widely touted by Defendants and, accordingly, extremely important to the valuation (and future success) of Ardelyx securities.

The FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act (“PDUFA”) date of April 29, 2021.

The Company repeatedly lauded this development, highlighting the FDA’s acceptance and review of the NDA, supported by so-called “successful” Phase 3 studies, in each subsequently filed quarterly report and in the Company’s 2020 annual report.  Even when the FDA requested that the Company provide additional information related to Ardelyx’s clinical data, which caused the PDUFA date to slip by three months, Defendants continued to hype Ardelyx’s “positive” clinical trial results, which, according to them, showed “improvements” over current treatments, supported tenapanor’s “clinical safety and efficacy,” and reinforced its “potential” as a “transformative” treatment.  At no point did Defendants state (much less suggest) that there may be fatal issues with the drug, its clinical trial data, or both.  Rather, Defendants simply claimed that the FDA’s request was merely because they needed help to “better understand the clinical data in light of tenapanor’s novel mechanism of action as compared to approved therapies.”

Defendants’ rosy narrative, however, came to a halt after the market closed on July 19, 2021.  At that time, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, that said the administration had found deficiencies that precluded discussion around the would-be labeling and post-marketing requirements for tenapanor.  Critically, the FDA said it detected issues with both the size and clinical relevance of the drug’s treatment effect.

Immediately, analysts cut their price targets and downgraded the Company’s rating.  Piper Sandler, for example, rated Ardelyx neutral (down from a buy-equivalent rating) and wrote, “we struggle to see a path forward for Tenapanor.”  Raymond James, another analyst, reset the Company’s price target to $4.00 from $14.00 per share.

The Company’s share price likewise plummeted, falling $5.69 per share, or nearly 74%, in a single day, to close at $2.01 per share on July 20, 2021, before falling another 4.2% by market close on July 21, 2021.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:

Robert S. Willoughby

Pomerantz LLP

[email protected]

888-476-6529 ext. 7980

SOURCE Pomerantz LLP

Related Links

www.pomerantzlaw.com

Los Angeles, California–(Newsfile Corp. – August 6, 2021) – The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Ardelyx, Inc. (“Ardelyx” or “the Company”) (NASDAQ: ARDX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company’s securities between August 6, 2020 and July 19, 2021, inclusive (the ”Class Period”), are encouraged to contact the firm before September 28, 2021.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm’s website at www.schallfirm.com, or by email at brian@schallfirm.com.

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. Ardelyx knew or had reason to know that the data it submitted to the FDA as part of the New Drug Application (“NDA”) for tenapanor was insufficient. The Company’s NDA demonstrated a lack of clinical relevance for the drug’s treatment effect. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Ardelyx, investors suffered damages.

Join the case to recover your losses.

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
info@schallfirm.com

SOURCE:

The Schall Law Firm

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92352