Earnings Call Transcript - ARDX Q4 2021

Operator, Operator

Good afternoon and welcome to Ardelyx's Fourth Quarter and Year-End 2021 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks. As a reminder, today's call is being recorded. I would now like to turn the call over to Justin Renz, Chief Financial Officer of Ardelyx. Sir, you may now begin.

Justin Renz, CFO

Thank you. Good afternoon, everyone and welcome to our first financial results call, a practice we intend to implement going forward as we march towards becoming a commercial stage company. During this call, we will refer to the press release issued earlier today, which is available in the Investors section of the company's website at ardelyx.com. On the call with me today are Mike Raab, President and CEO; and Susan Rodriguez, Chief Commercial Officer; Dr. Laura Williams, Chief Medical Officer; Dr. David Rosenbaum, Chief Development Officer; and Rob Blanks, Chief Regulatory Affairs and Quality Assurance Officer, who will join us for the question-and-answer period. 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 annual report on Form 10-K, which we filed today and also can 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. With that, let me pass the call over to Mike.

Mike Raab, President and CEO

Thank you, Justin and good afternoon, everyone. It's exciting for me to kick off what will now be quarterly calls on the eve of launching our commercial product IBSRELA in the coming weeks. What is so important to understand about IBSRELA is that it represents a significant advance and innovation for treating irritable bowel syndrome with constipation in adults. With over 5 million prescriptions written annually, it remains a significant unmet need for many of those patients. Compared to current treatment choices, IBSRELA provides a unique mechanism of action offering physicians and patients different options to address the debilitating impact of IBS-C. Today’s dynamics around the IBS-C market and particularly with IBSRELA make it a very compelling opportunity for patients, the company, and our shareholders. This is a significant inflection point for Ardelyx and we are excited to bring our innovative product to market as a commercially focused organization. I would like to review a few key points. Number one, we see highly favorable dynamics as we prepare for launch. The IBS-C market has been cultivated and expanded over the past 10 years and is ready for a differentiated product with a unique mechanism of action. Two, the established prescription market includes over 1.6 million IBS-C patients treated with currently available therapies, with at least 35% of whom are inadequately managed and in need of effective treatment alternatives. Three, this is a highly concentrated market with 9,000 physicians responsible for approximately 50% of over 5 million annual prescriptions for IBS-C. This is a dynamic that is ideal for our focused, targeted, specialized sales force, all of whom have been hired, trained, and are preparing for launch. And four, based on thoughtful, well-considered assumptions of mid to high single-digit penetration in the IBS-C market, we expect to achieve peak annual net revenue of over $500 million with a clear path ahead of us to achieve breakeven and ultimately profitability for the product, which we believe will create significant shareholder value. Susan will review our IBSRELA launch plans in more detail later on the call. But before that, I'd like to update you on the progress we are making at the FDA with our Formal Dispute Resolution Request for Tenapanor and hyperphosphatemia. To remind you, our initial appeal was filed with the FDA's Office of Cardiology, Hematology, Endocrinology, and Nephrology on December 2, 2021. Following an information request from the office on December 22, we submitted an additional analysis on January 7 of this year. As we had anticipated, on February 4, we received an appealed denial letter from the office. Also, in February, we then filed our second appeal with the Center for Drug Evaluation and Research, Office of New Drugs. If accepted for consideration, we expect a decision on the second appeal in April of this year, and we'll keep you updated as progress is made. Meanwhile, Kyowa Kirin or KKC, our partner for Tenapanor in Japan, has now completed three of four planned Phase 3 studies in adult patients on dialysis. And although we're not yet able to disclose the results of their studies, on February 7, KKC announced positive results from one of their Phase 3 studies and their plans to file for approval of Tenapanor in Japan in the second half of ‘22, with potential regulatory clearance in the second half of 2023. Tenapanor continues to offer great promise as an important and novel treatment for hyperphosphatemia for adult patients with chronic kidney disease on dialysis. The comprehensive clinical data generated for Tenapanor in this indication are consistent and support safety and efficacy as a twice-daily oral therapy. We will continue to push the FDA Dispute Resolution process on behalf of patients and their treating physicians, whom we know deserve better therapeutic alternatives to address the challenges of managing serum phosphorus. In addition, we continue to advance our small molecule potassium secretagogue program RDX013 as a potential treatment for hyperkalemia. We are in the process of evaluating the efficacy, safety, and pharmacodynamics of RDX013 in adult patients with hyperkalemia from our Phase 2 study, with the next steps to be determined based on the final analysis of these results, continued formulation development, and sufficient financial resources. We also continue to make progress with our RDX020 program, a bicarbonate exchange inhibitor to treat metabolic acidosis, a highly prevalent comorbidity in CKD patients that is strongly correlated with disease progression and adverse outcomes. We have identified lead compounds that are potent, selective, and proprietary inhibitors of bicarbonate secretion. We continue to advance this program utilizing third-party CROs. To summarize, Ardelyx is well-positioned with an approved product launching in a large market with few competitors, a strong pipeline of internally discovered drug candidates, a talented team that will drive our success, and an anticipated revenue stream that has the potential to transform the company into a profitable entity. To that end, I believe that we are uniquely poised to weather projected near-term market volatility with a much higher probability for long-term success. Now, I'd like to pass the call to Susan to share details on the launch.

Susan Rodriguez, Chief Commercial Officer

Thanks, Mike. Our team is excited and ready to execute a successful launch of IBSRELA. The market need is clear, we can efficiently reach key prescribers and our research confirms that the novel mechanism and strong efficacy data of IBSRELA will fuel market receptivity. Over the past decade, the introduction of GCC agonists has transformed the management of IBS-C, with market-building investments converting what was once an OTC market to an established prescription therapy market. The market basket of IBS-C indicated products includes Linzess, Trulance, Amitiza, and Zelnorm, with the market increasingly consolidated around two branded therapies that combined have 84% market share. Despite the active use of these therapies, HCPs persistently report that over a third of patients under their care continue to have symptoms and are considered to be inadequately managed. This relatively uncluttered market with the stated need for expanded therapeutic options is an ideal opportunity for IBSRELA with its novel mechanism and compelling and differentiated clinical profile. All key commercial elements needed to drive the successful launch of IBSRELA are in place. We are ramping up our product supply and have mobilized our highly experienced specialty sales force and commercial team to engage with our targeted high writers, introduce Ardelyx, and inform them that IBSRELA is coming soon. Our go-to-market plan and strategy for IBSRELA is informed by comprehensive market research and analysis. Our commercialization focus is on physicians who are high prescribers of the GCC agonists, targeting patients that are currently under their care. Our research showed that 56% of high prescribers consider IBS-C to be a difficult condition to treat, and 83% reported a significant unmet need with more than one-third of patients currently being treated with prescription therapies continuing to suffer from symptoms of IBS-C. The dissatisfaction centered on the efficacy parameters of abdominal pain and bloating. 75% of high prescribers reported a favorable response to the IBSRELA profile, rating its novel mechanism and efficacy data as the most compelling attributes and projected use of IBSRELA in a meaningful subset of their patients. Key elements to our commercialization strategy include: one, leveraging the market need for expanded therapeutic options to treat IBS-C. Our commercial efforts will be centered on high writing HCPs for patients where the novel mechanism and clinical profile represented by IBSRELA would provide an attractive therapeutic alternative. Two, IBSRELA will be positioned as a first-in-class NHE3 inhibitor with a triple action in treating IBS-C. Three, messaging will emphasize the IBSRELA mechanism of action is differentiated from existing therapies and the clinical data demonstrating significant improvement in abdominal pain, bloating, and constipation with a quick onset of action and sustained efficacy. Messaging will also emphasize the demonstrated clinical results of improved patient quality of life versus placebo and patient-reported treatment satisfaction. This positioning and messaging focus will establish IBSRELA with its new mechanistic approach and triple acting effect as a meaningful new tool in the treatment toolkit for HCPs who treat patients with IBS-C. Four, our sales force efforts targeted at the highest writers will be further amplified by omnichannel tactics leveraging the rapidly advancing dynamics in the marketplace on how and where HCPs receive their information. Five, we will have broad-based distribution including retail and specialty channels to accommodate office and patient preferences on where they wish to pick up their prescription and to align to their existing processes for handling specialty products. Six, we have set the price for IBSRELA based on the value it will provide patients in this established therapeutic space with a limited number of options and a recognized unmet clinical need. Within the IBS market pricing landscape, which ranges from $450 a month to $2,200 a month, we have set the launch price for IBSRELA to be $1,500 per month. As you think about the first few months and quarters of the launch, here is what to expect. We will be stocking the channel early in Q2. Throughout Q2 and through Q4, our sales force will be focused on the highest writers with a key focus on the highest writing GIs to build the foundation of use for IBSRELA to support continual expanded use. IBSRELA will have a strong commercial and clinical data presence at the largest GI Conference, Digestive Disease Week, that will take place in Q2 in San Diego. We will be working with payers to secure access for IBSRELA as a novel product. Our access strategy is centered on the value proposition of addressing the existing clinical unmet need among actively treated patients and rebating not to match existing agents, but to minimize the step-through requirements. We will leverage the current processes in place in GI offices that are well-established to address access requirements for the agents commonly prescribed in GI practice, such as agents to treat IBS-C, IBS-D, ulcerative colitis, Crohn's disease, and HCV, which are all therapeutic areas associated with payer restrictions. Uptake of IBSRELA over the first few quarters will be enabled by the pent-up demand of IBS-C patients currently under the care of an HCP who are inadequately managed and good candidates for treatment with IBSRELA, counterbalanced by access ramp-up challenges and the criticality of the HCP demand motivation to work through payer hurdles. As Mike mentioned, our promotional focus will be centered on the 9,000 high writing physicians who account for approximately 50% of prescriptions written for drugs indicated for IBS-C. With a targeted specialty sales force, full company engagement, and innovative omnichannel peer-to-peer and digital initiatives, we will bring IBSRELA to the patients being actively managed today who are in need of additional treatment options. From a payer landscape perspective, prior authorizations and step therapy protocols for novel entrants are standard for this market today, with HCPs having to attest to the fact that patients are not adequately responding to preferred agents. We expect that payers will put in place step therapy requirements for IBSRELA. We consider these payer challenges to be addressable on the basis of four key considerations: one, the patient need for IBSRELA; two, HCP demand for IBSRELA; three, HCP familiarity and experience in addressing the step hurdles implicit in the space; and four, the comprehensive customer service support we will have in place to support physician offices. In parallel, we will work to put in place contracts to secure access and minimize step therapy requirements. We are within weeks of launching IBSRELA and are thrilled to bring this much-needed, highly differentiated therapy to market and, most importantly, to make a difference in the lives of patients who are suffering from IBS-C. I will now turn the call over to Justin to review our Q4 and year-end 2021 financials.

Justin Renz, CFO

Thank you, Susan. At the end of the fourth quarter 2021, we had total cash, cash equivalents, and short-term investments of $116.7 million as compared to total cash, cash equivalents, and investments of $188.6 million as of December 31, 2020. As announced last week, we paid off our existing debt with Solar Capital Limited and the Life Sciences Group at Bridge Bank in full, and we have now entered into a new term loan with SLR Capital Limited for $27.5 million with two years interest only and an option for an additional $22.5 million in term loan debt if XPHOZAH receives approval and certain other conditions. We generated $10.1 million in revenue for the year ended December 31, 2021, an increase of $2.5 million, or 33%, compared to $7.6 million for the year ended December 31, 2020. The increase in our revenue was primarily attributable to a $5 million development milestone, which we earned upon the initiation of Phase 3 clinical studies in Japan by KKC to evaluate Tenapanor for hyperphosphatemia. Research and development expenses were $91.1 million for the year ended December 31, 2021, an increase of $26.1 million or 40% compared to $65.1 million for the year ended December 31, 2020. The increase in our R&D expenses was primarily the result of Tenapanor manufacturing costs, as we prepared for the launch of IBSRELA, and should we be successful in our appeal, the U.S. launch of XPHOZAH. In late 2021, we eliminated our research group and so in 2022, we expect our research and development expenses to be significantly lower than in 2021. R&D expenses for 2021 also included $2.7 million in severance payments and other employee-related restructuring costs. Selling, general and administrative expenses were $72.3 million for the year ended December 31, 2021, an increase of $39.2 million or 118% compared to $33.2 million for the year ended December 31, 2020. The increase in general and administrative expenses was primarily due to an increase in costs associated with building and staffing our commercial infrastructure as we prepare for the potential regulatory approval and U.S. launch of XPHOZAH. General and administrative employee-related expenses also included $3.5 million in severance payments and other employee-related restructuring costs. As Susan discussed, we have a focused IBSRELA commercial launch plan, and as a result, we expect our 2022 SG&A expenditures to be slightly less than in 2021. Net loss for the year ended December 31, 2021 was $158.2 million compared to $94.3 million for the year ended December 31, 2020. We will address our operating cash flow requirements with our current cash and investments, revenue generated from sales of IBSRELA, our potential receipt of anticipated milestone payments from our collaboration partners, prudent cash management, and the potential to access the capital markets. In addition to our debt refinancing, we are actively pursuing other non-equity solutions to extend our cash runway further into 2023 to support our planned operations and support the IBSRELA launch, and we have a lot of confidence in our ability to fund these operations. Today, we received notice from NASDAQ that our bid price has closed below $1 for 30 consecutive trading days. We received a deficiency notice that advised us that we’ve been afforded a compliance period of 180 calendar days to regain compliance with the applicable NASDAQ listing requirements. If we fail to regain compliance with NASDAQ's continued listing requirements, Nasdaq may take steps to delist our common stock or to move us from the NASDAQ Global Market tier companies to the NASDAQ Capital Markets tier. We plan to take action to avoid such delisting and to restore our compliance with NASDAQ's listing requirements. Additional disclosures are included in our Form 10-K which we filed today.

Mike Raab, President and CEO

Thanks, Justin. Despite some of these recent challenges, this is a monumental time for Ardelyx as we enter an important evolution to a commercial stage company. We are enthusiastic to enter the marketplace and offer patients with IBS-C a much-needed novel mechanism therapy. This transition differentiates us in the biopharma industry as a revenue-generating company with a clear line of sight to breakeven for IBSRELA and ultimately profitability for the product, which we believe will create significant shareholder value. We will have a strong and capable commercial presence and will be poised from a position of strength where additional commercial products could be leveraged, including the potential launch of Tenapanor for hyperphosphatemia upon a successful outcome of the formal dispute resolution process. Given what many would characterize as a tumultuous 2021 for Ardelyx, our pipeline diversification and visionary strategies have positioned us well for near-term and future growth. We believe that our focus on the patients and developing medicines to help them live longer and better lives will be successful for the patients and ultimately, for our shareholders. We look forward to keeping you apprised of our progress. And now with that, I will open the call to questions.

Operator, Operator

Thank you, speakers. Participants, we will now begin the question-and-answer session. Our first question is from Chris Raymond of Piper Sandler. Your line is now open.

Chris Raymond, Analyst

Hey, guys. Thanks for taking the question. I guess I need to ask a couple of weeks ago, you guys had an 8-K where you highlighted the outcome here and appeal to the office and new drugs, but I guess I was pretty intrigued by the language around potentially having a path to resubmit without running new trials. I mean, I guess, I'm just kind of curious no mention of that pathway here in this call. So can you maybe give a little bit of color? Is that path still open? Where does that stand I guess first and foremost?

Justin Renz, CFO

Yeah. Thanks for the question. No, that path still exists. We've expected. What we've been consistent in is saying that we believe any sort of positive outcome is going to come through SEDAR and LNG. So rather than go through the process at OCHEN, it made sense to then kick it upstairs as we've talked in the past and go through with them the process to hopefully be able to overturn the CRL. So our assumption is that alternative is still there, it opened up the door, but I think strengthens the process we're going through now through R&D, which was the strategy that we had said at the beginning that we would presume.

Chris Raymond, Analyst

Okay. So just so I understand the sequence then. So you go through the process with the Office of New Drugs, you get your answer in April. And then depending on that answer or the decision pursue the path of resubmitting based on some subset of the data that you already have, is that right?

Mike Raab, President and CEO

So I'll ask Rob Blanks to add a little bit more color, but the outcomes can be rejection. It can be overturning the remaining (ph) to cardio renal. It could be additional information requests or an advisory committee, right? So those are kind of the general outcomes that could be there. And those could be additional analyses as we suggested in our filing. Obviously, we don't have any way of predicting what it's going to be from where we are now. But the nuances if it's a two-month versus a six-month submission as we don't have an active NDA. So we would have to submit and resubmit in order to have discussions. Rob, anything to add?

Robert Blanks, Chief Regulatory Affairs and Quality Assurance Officer

No, Mike. I think you have it covered pretty well. I mean, the path still exists. We obviously, we feel that you only have one chance to go up to a higher level, and we felt that that was the best way to go. And certainly, we did not think that the OCHEN with Dr. Joffe, who is relatively new to that position would overturn them. So we still think we have a chance with the OND.

Chris Raymond, Analyst

Okay. Thank you very much.

Mike Raab, President and CEO

Thanks, Chris.

Operator, Operator

Next question is from taking Joseph Thome of Cowen. Your line is now open.

Peyton Bohnsack, Analyst

Hi, guys. This is Peyton on for Joe. So, kind of following up on that, how would you plan or rebalance additional investment in the hyperphosphatemia program, with that potential inclusion in the dialysis bundle and if the ‘23 timeframe for inclusion is still likely to stand? And then I've got a follow-up as well.

Mike Raab, President and CEO

Sure. I mean I think we're taking this in a stepwise fashion. We believe wholeheartedly that patients deserve this drug first and foremost. And as we were speaking over the past, the opportunity that exists even in a bundled scenario, we think allows for a great opportunity commercially. We believe there continues to be an opportunity to extend the exclusion that work is ongoing. So lots of different obviously, balls in the air, but additional investments in XPHOZAH would depend upon what that looked like. I think we have been consistent in saying that doing what was implied in the CRL of doing an outcome study is not on the table. There is no other phosphorus-lowering therapy that has ever been required to do that and that is a big part of the basis of our FDRR. So we continue to be committed to seeing this through; anyone who knows me knows that I'm stubborn and want to find a path to get this product to the patients who still need it.

Peyton Bohnsack, Analyst

Thank you. That's really helpful. And then kind of the second question, kind of more on IBSRELA in Europe. What are kind of the plans? And have there been any discussions of partnership or do you plan on potentially launching XPHOZAH?

Mike Raab, President and CEO

No, I think we'll wait and see how we do here. We begin the conversations with folks that have reached out and will reach out to other folks as well. I mean, we're a relatively small team doing a lot and want to focus on the U.S. launch before distracting ourselves and trying to do those.

Peyton Bohnsack, Analyst

All right. Thank you so much.

Mike Raab, President and CEO

Sure. Thank you.

Operator, Operator

Next question is from Laura Chico of Wedbush Securities. Your line is now open.

Sam Brandeis, Analyst

Hi. So this is Sam on for Laura Chico. I'm wondering at this point for the IBSRELA launch. What are the key gating factors to launching in the second quarter? And then I'm just wondering if your view on market positioning in the few months that you've had to prepare has changed at all?

Mike Raab, President and CEO

Yeah. So let me just give a couple of comments, and I'll pass it off to Susan. We would have launched IBSRELA sooner had we had the material right. We were focused on the XPHOZAH launch making those tablets. So we had to shift our efforts to make it 50 milligram tablets. And that's really been the gating issue for us in preparation for launch. I will ask Susan to address your second part of your question; I would say that my conviction for what Susan has described, the opportunity to be has only increased over the months and no way decrease, given the dynamics of that marketplace. Susan?

Susan Rodriguez, Chief Commercial Officer

Yes, thank you, Mike. The commercial team at Ardelyx has been enhancing its capabilities over the past 18 months. A key part of establishing a commercially-focused company has been attracting exceptional talent with extensive experience in launching new products. Our initial step was to conduct a thorough evaluation of our asset portfolio and perform market research to understand the potential of each asset. This analysis guided us in optimizing those assets and developing a go-to-market strategy, including positioning and messaging for IBSRELA. We feel well-prepared to proceed with the launch of IBSRELA, especially considering the timing related to the FDA decisions for XPHOZAH. As Mike pointed out, a critical aspect was conducting timely research at the end of last year and early this year to validate our go-to-market strategy through extensive quantitative and qualitative research, along with comprehensive engagement with our opinion leaders to test our positioning and messaging. We are fully prepared and confident in our go-to-market strategy and readiness for this launch in Q2.

Sam Brandeis, Analyst

Okay. Thank you very much.

Operator, Operator

Next question is from Louise Chen of Cantor Fitzgerald. Your line is now open.

Carvey Leung, Analyst

Hi, good afternoon, everyone. This is Cantor on for Louise from Cantor. Thank you for taking our questions. Our first question is what are some takeaways you guys have gathered from Knight Pharma in the commercialization of IBSRELA in IBS-C in Canada that might be important in the States? How should we view the initial uptake of the drug? Any feedback from the provider community would also be helpful? Our second question is on peak annual revenue. You have highlighted a potential peak to be at least $500 million. We’re wondering how long it would take to get to the peak? Thank you so much.

Mike Raab, President and CEO

Susan, that's in your court.

Susan Rodriguez, Chief Commercial Officer

Great. Yeah. So first thing, Canada actually the COVID restrictions in Canada have really been quite significant. So while they have stacked the channel for IBSRELA, they really have not fully launched commercially in Canada. So it is too early to say exactly what the early read in terms of the opinion leader response and provider research in Canada is. The need for an alternative mechanism of therapy for IBS-C and other research findings are quite aligned with what we learned in the U.S. So that's all I can tell you at this time. And what's great is that we are very much aligned with the Canada commercial team for North America alignment on our go-to-market approach, messaging, positioning, communication of the data, and really leveraging the opinion leader community. So we'll continue to keep you posted on that as they are really just starting to ramp up their full commercial launch. In terms of your next question on provider response, here in the U.S., it's really very interesting. We’ve conducted both quantitative and qualitative research. It's quite persistent that there is a very established pattern of how to manage these IBS-C patients under their care. So keep in mind, I think everybody is accustomed to thinking about this market as a market-building market to bring patients into the physician's office to use the prescription therapies that have been available and introduced over the last decade. But what we have to remember now as we look forward to the launch of IBSRELA is that what we're looking at is a very established market where patients are under physicians' care, they see the physician regularly, and they churn through a lot of therapies in managing these patients because the symptoms persist. So what we hear back from doctors is that there is an unmet need, particularly along the pain and bloating. There is a high level of interest in a novel mechanism therapy and a strong intent to adapt the therapy in a very meaningful subset of patients. Notably, we see this not only across the high writing GIs; we see it across writing non-GIs, and we also see it across the opinion leader community on a national and regional level. Everything, all of the intelligence and insights are pointing towards this opportunity and the extent to which IBSRELA can address clinical unmet needs. And with our sales team now deployed across the country, there is a high level of receptivity to meet with our team and eagerness for our physicians to learn about the novel mechanism of IBSRELA.

Carvey Leung, Analyst

Got it. And just on the final piece, how long should it take to reach the peak for the drug?

Susan Rodriguez, Chief Commercial Officer

Yes. Sorry, that was your last question. Yes, so we had projected that over a five-year time frame.

Operator, Operator

Speakers, the next question is from the line of Matt Kaplan of Ladenburg Thalmann. Your line is now open.

Matt Kaplan, Analyst

Hi, good afternoon, guys, and thanks for taking questions.

Mike Raab, President and CEO

Hey, Matt.

Matt Kaplan, Analyst

Hi. So just wanted to maybe continue with Susan a little bit. Initially, in our prepared remarks, you said the uptake of IBSRELA is going to be driven by unmet need and coverage. Can you talk a little bit about how long coverage will take to get in place and what you see kind of coverage levels exiting this year and going into next and how we should think about that?

Susan Rodriguez, Chief Commercial Officer

Thank you for your question, Matt. We are currently working to educate payers on the clinical profile of IBSRELA. We expect that IBSRELA will ultimately be categorized as a Tier 5 specialty tier product. This expectation is based on the established nature of the IBS-C market, where it is quite unusual for branded products to achieve strong Tier 2 and Tier 3 positions, as seen with LINZESS and Trulance. We are not competing directly with those products. Our focus is on addressing the clinical unmet need, as there is no alternative to IBSRELA for patients with persistent symptoms. That is the value proposition we will present to payers. Our goal is to secure access through contracting and to minimize prior authorization and step therapy hurdles, but we do not plan to match the rebate levels of LINZESS and Trulance, nor do we expect to achieve comparable formulary positions. The main opportunity lies in addressing the unmet need, the novel mechanism of our drug, and the clinical package. We will collaborate with payers throughout 2022 to secure access for IBSRELA, and by 2023, we will be able to provide updates on the access situation. Additionally, it is important to note that prescriptions can still be filled if the prescribing physician is willing to navigate the medical exception process. To demonstrate the demand for IBSRELA to the payers, we will work closely with them to support the approval process for IBSRELA prescriptions through the exception procedure following the launch.

Matt Kaplan, Analyst

Okay. That's very helpful. Thank you. And then I guess one more for you, Susan, in terms of what commercial metrics do you plan to share with us on a quarterly basis beyond? I guess, obviously reporting revenues but helping us to gauge your success in the launch?

Susan Rodriguez, Chief Commercial Officer

Yeah. So clearly, reporting revenues is a primary metric that we will be sharing with you. I think we all need to be cognizant of the typical ramp-up of accuracy of data capture for IQVIA scripts. And that will be very much determined by the profile, the mix of maybe retail versus specialty and reporting capture. So over time, as we get to a steady state for IQVIA capture, we will be reporting on our scripts and our share penetration.

Matt Kaplan, Analyst

Okay. And then just going back to the OND, how does the process work now with OND until they arrive at an answer in April? Is there significant interaction between you and that part of the agency?

Mike Raab, President and CEO

Rob?

Robert Blanks, Chief Regulatory Affairs and Quality Assurance Officer

Yes. We've obviously, we submitted the appeal and then we have, it's potential to have a meeting with them by the end of, if they have 30 days to review. So by the end of that process, we have the potential to have a meeting with them that meeting will likely not be face to face, but we could have a meeting with them, and we could also get information requests from them asking for more information. So there is plenty of opportunity for interaction with the OND.

Mike Raab, President and CEO

That's helpful. Thanks. And just a quick question for Justin Renz. He mentioned in his prepared remarks the elimination of the R&D group late last year, and that would have a significant impact on R&D. Can you help quantify that for us?

Justin Renz, CFO

I can't really give specifics out, Matt, yet other than it will be substantially reduced, because as you know, our clinical process we've wrapped up the preponderance of our work with the Phase 4 programs that David Rosenbaum and Laura led for us, and we are doing no novel new research in 2022, so it's going to be substantially less than last year.

Matt Kaplan, Analyst

Okay. Thank you. Thanks. Thanks for that deal.

Mike Raab, President and CEO

Thanks, Matt.

Operator, Operator

Thank you, participants. I'll now turn the call back over to Michael Raab for final remarks.

Mike Raab, President and CEO

Thank you all for joining our call. This is indeed a transformational year for Ardelyx with our launch of IBSRELA for patients with IBS-C. We look forward to keeping you apprised of our progress in the coming months and Jessey, you may now end the call. Thank you.

Operator, Operator

Thank you, speakers. This concludes today's conference call. Thank you all for joining. You may now disconnect.