Ardelyx, Inc. (NASDAQ:ARDX) Q3 2023 Earnings Conference Call October 31, 2023 8:00 AM ET Company Participants Caitlin Lowie - Vice President of Corporate Communications & Investor Relations Mike Raab - President & Chief Executive Officer Susan Rodriguez - Chief Commercial Officer Justin Renz - Chief Financial Officer & Chief Operations Officer Conference Call Participants Louise Chen - Cantor Yigal Nochomovitz - Citi Research Joseph Thome - TD Cowen Matt Kaplan - Ladenburg Thalmann Operator Good day and wel ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36485 ARDELYX, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-1303944 (State or Ot ...

Corporate Presentation Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding Ardelyx, they are forward- looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s expectations regarding full year 2023 IBSRELA net sales revenue, potential commercial opportunities and other opportunities for the company, Ar ...

Ardelyx, Inc. (NASDAQ:ARDX) Q2 2023 Earnings Conference Call August 2, 2023 8:00 AM 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 Peyton Bohnsack - TD Cowen Dennis Ding - Jeffries Matthew Kaplan - Ladenburg Thalm ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36485 ARDELYX, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-1303944 (State or Other J ...

Financial Data and Key Metrics Changes - Ardelyx reported net product sales of IBSRELA at $11.4 million for Q1 2023, reflecting a 31% increase from Q4 2022 [6][17] - The cumulative net product sales for IBSRELA since its launch reached $27 million [17] - The net loss for Q1 2023 was 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 Q1 2022 [18] - Total cash, cash equivalents, and short-term investments as of March 31, 2023, were $130.4 million, up from $123.9 million at year-end 2022 [19] Business Line Data and Key Metrics Changes - IBSRELA sales increased by 31% over the previous quarter, indicating strong market uptake [6][9] - The company is preparing for the launch of XPHOZAH, with a resubmission of the NDA on April 17, 2023, and expects a goal review date from the FDA in mid-May [6][7] Market Data and Key Metrics Changes - The IBS-C market is characterized by a significant unmet medical need, with approximately 77% of patients continuing to experience symptoms despite existing treatments [11] - The company anticipates IBSRELA could achieve a mid to high-single digit peak market share, potentially making it a $500 million product at peak [15] Company Strategy and Development Direction - Ardelyx focuses on executing its commercial strategy for IBSRELA and preparing for the launch of XPHOZAH, leveraging insights from nephrology research [6][7] - The collaboration agreement with METiS Therapeutics aims to develop TGR5 agonist compounds, enhancing the company's cash position and pipeline [7][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of IBSRELA and the anticipated launch of XPHOZAH, highlighting strong market interest and unmet needs in both therapeutic areas [6][7][15] - The company is committed to thoughtful funding strategies to maximize shareholder value while preparing for future launches [20][21] Other Important Information - The company reported a significant increase in selling, general, and administrative expenses, primarily due to the commercialization efforts for IBSRELA [18] - The gross-to-net profile for IBSRELA was reported at 33.7% for Q1 2023, with expectations for it to decline over the year [31] Q&A Session Summary Question: Can you help with the math for IBSRELA for the first quarter? - Management noted that growth trajectories from IQVIA and Symphony are comparable, explaining discrepancies in script data [26] Question: What is the gross-to-net for the first quarter? - The gross-to-net was reported at 33.7%, expected to decline to the higher 20% range by year-end due to copay resets and access dynamics [31] Question: What is the anticipated review timeline for hyperphosphatemia? - Management expects a six-month review as the base case, with confirmation expected by mid-month [34] Question: Can you expand on the prescribing breadth for IBSRELA? - Management indicated consistent repeat writing and positive experiences from physicians, contributing to growth [36] Question: How has the intent to prescribe XPHOZAH changed over time? - Recent research indicates high levels of unmet need and awareness for XPHOZAH, with comparable intent to adopt metrics [40] Question: What is the launch preparation status for XPHOZAH? - The company is mobilizing its established marketing and commercial operations to prepare for the launch of XPHOZAH [56]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36485 ARDELYX, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-1303944 (State or Other ...

Financial Data and Key Metrics Changes - Net product sales for IBSRELA in Q4 2022 were $8.7 million, a 78% increase from Q3 2022 sales of $4.9 million [13][23] - Total revenue for IBSRELA for 2022 was $15.6 million, reflecting strong growth momentum [13][23] - Collaboration revenue for the full year 2022 was $36.6 million, compared to $10.1 million in 2021, with a significant portion from milestone payments [23] - Net income for Q4 2022 was approximately $11 million, or $0.06 per fully diluted share, while the net loss for the year was $67.2 million, a reduction from a net loss of $158.2 million in 2021 [25] Business Line Data and Key Metrics Changes - IBSRELA demonstrated significant quarter-over-quarter prescription growth, with over two-thirds of surveyed GIs reporting its unique mechanism of action [8][14] - The company expects to capture a mid to high single-digit share of the 5 million prescription IBS-C market, potentially yielding peak revenue of at least $500 million [10][12] Market Data and Key Metrics Changes - The market for hyperphosphatemia treatment is in need of new alternatives, with 77% of patients unable to maintain target levels despite existing treatments [16] - XPHOZAH is positioned as a first-in-class phosphate absorption inhibitor, addressing a significant unmet need in the market [17] Company Strategy and Development Direction - The company aims to develop innovative first-in-class medicines that meet significant unmet medical needs, with a focus on IBSRELA and XPHOZAH [7][12] - Ardelyx is preparing for the potential launch of XPHOZAH in the second half of 2023, leveraging its established commercial capabilities [18][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future potential of Ardelyx, highlighting the successful commercialization of IBSRELA and the path forward for XPHOZAH [28][62] - The company is focused on maximizing shareholder value while pursuing non-equity solutions for funding [26] Other Important Information - The company has a strong balance sheet with total cash and short-term investments of $123.9 million as of December 31, 2022 [25] - Ardelyx issued its first-ever ESG report, demonstrating its commitment to stakeholder issues [28] Q&A Session Summary Question: What is the latest expectation for cash runway? - Management indicated confidence in funding operations with approximately $121 million in cash as of February 28, 2023, and a cautious approach to spending [30][32] Question: Did anything happen in the Type A meeting that affected the review timeline? - Management maintained a base case expectation of a six-month review for the NDA resubmission, with no new insights suggesting a shorter timeline [33][34] Question: What is the gross to net ratio for IBSRELA? - The gross to net ratio for 2022 was approximately 28%, indicating a stable reduction [39][40] Question: Are there any risks of delays in the review process? - Management expressed confidence in the approval path for XPHOZAH, indicating that the appeal granted suggests a solid path to launch [41][42] Question: What are the preparations for the launch of XPHOZAH? - Preparations are well underway, with established commercial infrastructure and a dedicated nephrology salesforce ready to mobilize [52]

IBSRELA (Tenapanor) for IBS-C - IBSRELA is a first-in-class therapy for Irritable Bowel Syndrome with Constipation (IBS-C) in adults, indicated at 50 mg BID[8, 28] - In clinical trials, diarrhea was a common adverse reaction, occurring in 16% of IBSRELA-treated patients versus 4% in the placebo group[7, 32] - A Spherix survey reported that 60% of surveyed GIs have adopted IBSRELA[13] - IBSRELA recorded $15.6 million in net sales since launch in March 2022 (as of Dec 31, 2022)[19, 39] - The U S IBS-C market has 5 2 million prescriptions for indicated products in 2022[22, 34] and $3 1 billion in sales[24] XPHOZAH (Tenapanor) for Hyperphosphatemia - XPHOZAH is an investigational, first-in-class phosphate absorption inhibitor for hyperphosphatemia treatment, pending FDA review[42] - In clinical trials, diarrhea (47%) was the most common adverse reaction reported in XPHOZAH-treated patients[54] - A Spherix survey reported that 72% of nephrologists reported a high interest in XPHOZAH[59] - Approximately 80% of over 550,000 U S patients with CKD on dialysis require Rx treatment for hyperphosphatemia[42, 45] Corporate Strategy and Financials - Ardelyx is focused on developing and commercializing therapies for unmet needs in established therapeutic areas[15, 74] - Ardelyx had $123.9 million in cash and investments as of December 31, 2022[69]

Financial Performance and Position - The company has incurred an accumulated deficit of $780.1 million as of December 31, 2022, and has not been profitable since its inception in October 2007[109]. - The company expects to continue incurring substantial operating losses as it commercializes IBSRELA and seeks approval for XPHOZAH, with no assurance of future profitability[110]. - The company has substantial net operating loss and tax credit carryforwards, but their future utilization may be limited due to ownership changes[112]. - The revenue potential from IBSRELA is unpredictable and subject to various market factors, which could adversely affect the company's results of operations[122]. - The company may require additional financing to support the commercialization of IBSRELA and the potential launch of XPHOZAH, which could impact its operations if not secured[115]. - As of December 31, 2022, the company had cash, cash equivalents, and short-term investments totaling $123.9 million, consisting of bank deposits, money market funds, and high-quality fixed income instruments[386]. - The company’s borrowings under the 2022 Loan Agreement bear interest at a floating rate of 7.95% plus the greater of 0.10% or the one-month ICE rate, with an aggregate principal amount of $26.7 million outstanding[387]. - The company incurs significant legal, accounting, and compliance costs as a public company, which may affect its financial position and operational efficiency[261]. - The company is subject to Section 404 of the Sarbanes-Oxley Act, requiring substantial expenses and management efforts to ensure effective internal control over financial reporting[262]. - The company may experience immediate dilution if it sells shares of common stock at a discount from the current trading price, potentially leading to a decline in stock price[259]. - The company faces risks associated with the global economic environment, including inflationary pressures and rising interest rates, which could adversely affect its financial performance[265]. Product Development and Commercialization - The company began commercializing its first product, IBSRELA, in March 2022, but has generated limited revenue from product sales to date[108]. - The company plans to address its operating cash flow requirements through current cash, sales from IBSRELA, potential sales from XPHOZAH, and anticipated milestone payments from collaboration partners[110]. - The company is preparing to resubmit its NDA for XPHOZAH following a favorable decision from the FDA regarding its appeal of a Complete Response Letter[116]. - The commercial success of IBSRELA will depend on factors such as market acceptance, coverage and reimbursement by third-party payors, and the effectiveness of the treatment[120]. - The company anticipates launching XPHOZAH in the second half of 2023 if approved, but acknowledges that market acceptance and reimbursement are uncertain[124]. - The commercial success of XPHOZAH will depend on third-party manufacturers' ability to supply adequate product quantities and the content of the FDA-approved label[126]. - The company has limited experience in building a commercial organization, which may adversely affect the commercialization of IBSRELA and XPHOZAH[129]. - Collaboration partnerships for the commercialization of tenapanor are in place, but competition for suitable partners is significant and may delay product development[174]. Regulatory and Compliance Risks - The company faces significant uncertainty regarding the insurance coverage and reimbursement for newly approved products, particularly for XPHOZAH[119]. - The company is subject to extensive governmental price controls and market regulations internationally, which may pressure pricing and usage of IBSRELA and XPHOZAH[132]. - The company is subject to complex regulations regarding the promotion of products for unapproved uses, which could lead to significant legal and financial repercussions[200]. - Disruptions at regulatory agencies like the FDA could hinder timely reviews and approvals, adversely affecting the company's business[194]. - The company must comply with various healthcare laws, including the Anti-Kickback Statute and false claims laws, to avoid significant penalties and operational disruptions[210]. - Changes in healthcare regulations could require additional clinical trials or modifications to manufacturing processes, potentially delaying product approvals[213]. - The company faces risks related to manufacturing processes, including the need for compliance with cGMP regulations and potential delays in regulatory approvals[195]. - Any failure to maintain regulatory compliance could lead to severe consequences, including withdrawal of product approvals and suspension of production[198]. - The company is exposed to misconduct risks from employees and third parties, which could result in significant legal and financial penalties[206]. - Failure to obtain regulatory approvals in foreign jurisdictions could hinder the company's ability to market products internationally[207]. Intellectual Property Risks - The company relies on a combination of legal measures to protect its intellectual property, but these measures may not provide sufficient protection against competitors[227]. - The company faces risks related to patent infringement claims, which could delay or prevent the commercialization of its products[236]. - There is uncertainty regarding the future protection of the company's proprietary rights, including the potential for challenges to its patents[234]. - The company may incur substantial damages if found willfully infringing third-party patents, impacting its commercial success[238]. - The company must navigate complex legal landscapes regarding intellectual property, which could divert management's attention from core business activities[238]. - The company may encounter significant problems in protecting and defending its intellectual property in foreign countries[245]. - The implementation of the European Unified Patent Court may create uncertainties regarding the protection and enforcement of patent rights in Europe[251]. - The company relies on trade secret protection and confidentiality agreements to safeguard proprietary know-how that may not be patentable[244]. Market and Competitive Landscape - The company faces significant competition in the biotechnology and pharmaceutical industries, with competitors having greater resources and name recognition[147]. - XPHOZAH, if approved, will compete with various phosphate binders, including generics available in the U.S.[148]. - The company is aware of at least four other phosphate binders in development, which may pose additional competition[149]. - The trading price of the company's common stock is highly volatile, influenced by various factors including regulatory decisions and commercialization success[256]. - The company cannot guarantee that it will successfully enforce its intellectual property rights, which could negatively impact its business[250]. Operational Risks - The company relies entirely on third-party manufacturers for IBSRELA and XPHOZAH, which poses risks related to compliance and supply chain management[135]. - The ongoing effects of the COVID-19 pandemic may disrupt manufacturing and clinical development activities, impacting the commercialization of products like IBSRELA and XPHOZAH[176][178]. - The company may incur substantial costs and delays if it needs to switch manufacturers due to compliance issues or supply interruptions[199]. - The company does not carry earthquake insurance, which poses a risk to operations in the earthquake-prone San Francisco Bay Area[185]. - The company faces increased scrutiny from regulatory authorities as it expands operations, which may lead to complex compliance issues[160][162]. Data Protection and Cybersecurity - The company must comply with data protection and privacy laws, as failures could adversely affect its business and financial condition[158]. - The company is subject to numerous evolving data protection laws, including HIPAA and CCPA, which impose high compliance costs and potential penalties for violations[160][161][164]. - The California Privacy Rights Act (CPRA), effective January 1, 2023, imposes additional obligations on businesses, increasing the risk of data breach litigation[161]. - The European Union's General Data Protection Regulation (GDPR) imposes fines of up to €20 million or 4% of annual global revenues for noncompliance, creating significant compliance risks[164]. - Cybersecurity risks have increased due to the rise in sophisticated cyberattacks, which could lead to data breaches and significant costs for the company[170][171]. - The company has established measures to safeguard its information technology systems, but vulnerabilities remain due to reliance on third-party vendors[167][169].