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Ardelyx (ARDX) reported $97.66 million in revenue for the quarter ended June 2025, representing a year-over-year increase of 33.4%. EPS of -$0.08 for the same period compares to -$0.07 a year ago.The reported revenue represents a surprise of +15.39% over the Zacks Consensus Estimate of $84.64 million. With the consensus EPS estimate being -$0.13, the EPS surprise was +38.46%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Stree ...

Financial Data and Key Metrics Changes - The company reported total revenue of $97.7 million for Q2 2025, representing a 33% year-over-year growth compared to $73.2 million in Q2 2024 [25] - The net loss for Q2 2025 was approximately $19.1 million, or $0.08 per share, compared to a net loss of $16.5 million, or $0.07 per share in the same period last year [31] - The company ended Q2 2025 with $238.5 million in cash, cash equivalents, and short-term investments, including $48.7 million of incremental debt [32] Business Line Data and Key Metrics Changes - Ibsrela generated $65 million in net sales revenue for Q2 2025, reflecting an 84% year-over-year growth and a 46% quarter-over-quarter growth [6][11] - Exposa recorded net sales revenue of $25 million in Q2 2025, a 7% increase compared to Q1 2025, and a 27% increase when excluding a one-time reserve release from Q1 [7][28] Market Data and Key Metrics Changes - The demand for Ibsrela in Israel showed broad-based growth with record highs across all key indicators, leading to an increase in full-year guidance for net sales revenue to $250 million to $260 million [6] - Exposa's performance was driven by improved access for patients and growth in non-Medicare payer segments, indicating a positive response to promotional messaging from the sales team [18][19] Company Strategy and Development Direction - The company is focused on executing its commercial strategy effectively, with plans to continue expanding the prescribing base for both Ibsrela and Exposa [15][21] - The leadership team has been strengthened with new appointments to support the next phase of growth, including the promotion of Mike Kelleher to Chief Business Officer [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving peak sales of over $1 billion for Ibsrela and $750 million for Exposa, citing strong patient demand and improved prescription pull-through [16][21] - The company is optimistic about continued growth throughout 2025, with a focus on maintaining high execution levels [21] Other Important Information - The company has drawn an additional $50 million of debt to enhance financial flexibility, bringing total outstanding debt to $200 million [32] - The company has completed its $75 million royalty obligation to AstraZeneca, which is now behind them [30] Q&A Session Summary Question: Update on potential EU partner and cash flow positive status - Management indicated that achieving cash flow breakeven is a near-term goal and that they are evaluating opportunities in Europe [38] Question: Clarification on new guidance for Ibsrela - Management stated that the $10 million increase in guidance reflects a meaningful step forward and is based on thoughtful analysis [44] Question: Sales growth attribution to expanded sales team - Management confirmed that the expanded sales team has significantly contributed to the increase in prescriptions and expects this trend to continue [50][52] Question: Contribution from transitional scripts for Exposa - Management noted that there was an inconsequential amount of transitional scripts in Q2 and that the mix is roughly 50/50 between Medicaid and commercial [60][118] Question: Confidence in new peak estimate for Exposa - Management expressed confidence in the new peak estimate for Exposa, citing a total available market of 220,000 patients and strong performance indicators [86] Question: Update on CMS legal proceedings - Management confirmed that arguments for the ongoing CMS case will be heard on September 25, with no statutory requirement for a response timeframe [79]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2025 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: 001-3648 ...

Exhibit 3.1 SECOND AMENDED AND RESTATED BYLAWS OF ARDELYX, INC. (a Delaware corporation) TABLE OF CONTENTS | | | Page | | --- | --- | --- | | ARTICLE | I - CORPORATE OFFICES | 1 | | 1.1 | REGISTERED OFFICE | 1 | | 1.2 | OTHER OFFICES | 1 | | ARTICLE | II - MEETINGS OF STOCKHOLDERS | 1 | | 2.1 | PLACE OF MEETINGS | 1 | | 2.2 | ANNUAL MEETING | 1 | | 2.3 | SPECIAL MEETING | 1 | | 2.4 | ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING | 2 | | 2.5 | ADVANCE NOTICE PROCEDURES FOR NOMINATIONS OF DI ...

Core Insights - Ardelyx, Inc. announced significant changes to its Executive Leadership Team, including the appointment of Edward Conner, M.D. as Chief Medical Officer and John Bishop, Ph.D. as Chief Technical Operations Officer [1][2][3] - Justin Renz, the current Chief Financial and Operations Officer, is expected to transition out of the company, with a commitment to assist during the transition period [4][5] Leadership Changes - Edward Conner, M.D. brings over 20 years of experience in advancing innovative therapies through clinical development and regulatory approval across various therapeutic areas [2] - John Bishop, Ph.D. has over 30 years of experience in leading technical operations, quality assurance, and regulatory activities, reflecting the importance of technical operations in the company's future success [3] - The company has also welcomed other leaders, including Mike Kelliher as Chief Business Officer and Laura Williams as Chief Patient Officer, to enhance its leadership capabilities [4] Company Vision and Future - The leadership changes are part of Ardelyx's strategy to position itself for the next phase of growth, focusing on building a robust pipeline and achieving its vision of creating a healthier tomorrow for patients [4] - Ardelyx has two commercial products approved in the U.S., IBSRELA and XPHOZAH, and has established agreements for the development and commercialization of tenapanor in various international markets [6]

Company reports strong commercial performance in the second quarter, recording $97.7 million in total revenue, reflecting 33% growth year-over-year IBSRELA generated net sales revenue of $65.0 million; XPHOZAH generated net sales revenue of $25.0 million Company ends Q2 with $238.5 million in cash, cash equivalents and investments Company raises 2025 IBSRELA net sales revenue expectations to $250-$260 million Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Aug. 04, 2025 (GLOBE NEWSWIRE) - ...

Company Overview - Ardelyx (ARDX) is expected to report a year-over-year decline in earnings despite higher revenues for the quarter ended June 2025, with a consensus outlook indicating a quarterly loss of $0.13 per share, representing an 85.7% decrease from the previous year [1][3] - Revenues are projected to be $84.64 million, reflecting a 15.6% increase compared to the same quarter last year [3] Earnings Expectations - The earnings report is anticipated to be released on August 4, and the stock may experience upward movement if the reported numbers exceed expectations; conversely, a miss could lead to a decline in stock price [2] - The consensus EPS estimate has been revised down by 6.25% over the last 30 days, indicating a reassessment by analysts regarding the company's earnings prospects [4] Earnings Surprise Prediction - The Most Accurate Estimate for Ardelyx is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -6.18%, which suggests a bearish outlook from analysts [12] - The company currently holds a Zacks Rank of 4, making it challenging to predict a beat on the consensus EPS estimate [12] Historical Performance - In the last reported quarter, Ardelyx was expected to post a loss of $0.10 per share but actually reported a loss of $0.17, resulting in a surprise of -70.00% [13] - Over the past four quarters, Ardelyx has beaten consensus EPS estimates two times [14] Industry Comparison - In the Zacks Medical - Drugs industry, United Therapeutics (UTHR) is expected to report earnings of $6.8 per share for the same quarter, indicating a year-over-year increase of 16.2% [18] - United Therapeutics' revenue is projected to be $795.75 million, up 11.3% from the previous year, with a revised consensus EPS estimate down by 2.4% over the last 30 days but an Earnings ESP of +7.09% [19][20]

Financial Performance & Expectations - Ardelyx reported $44.4 million in net sales revenue for IBSRELA and $23.4 million for XPHOZAH in Q1 2025[5] - The company finished Q1 2025 with $214.0 million in cash and investments[5] - Ardelyx anticipates U S IBSRELA net product sales revenue to be between $240 million and $250 million for the full year 2025[9, 64] - IBSRELA is projected to achieve approximately 10% market share at its peak, generating over $1 billion in net product sales revenue before its patent expires[9, 36] - XPHOZAH is expected to generate $750 million in annual net product sales revenue before its patent expires[41, 62] - Ardelyx expects aggregate peak revenue for both products to be greater than $175 billion annually before patent expiration[65, 76] Market Overview & Clinical Data - The U S IBS-C indicated net product sales reached $40 billion in 2024, representing a 16% increase compared to 2023[14] - TRxs for IBS-C indicated products have grown 21% from 2020 to 2024[15] - Approximately 70% of patients on phosphate binders are unable to consistently achieve and maintain target phosphorus levels over a 6-month period[39, 44, 62] - In a long-term Phase 3 trial, 365% of IBSRELA-treated patients were overall responders, compared to placebo[26, 27] - 96% of surveyed nephrologists rate XPHOZAH as a moderate or substantial advancement[57]

Summary of Ardelyx (ARDX) Conference Call Company Overview - Ardelyx has experienced significant fluctuations over the past few years, particularly since 2021 when it launched Ibsrela after overcoming a Complete Response Letter (CRL) from the FDA regarding Exposa [3][4] - The company currently markets two products: Ibsrela for IBS-C and Exposa for dialysis patients with hyperphosphatemia [4][5] Financial Guidance and Performance - Ardelyx reaffirmed its revenue guidance for Ibsrela at $240 million to $250 million for the current year [5][12] - The company noted that the IBS-C market has been growing at double digits for the past three to four years, with 50,000 new patients starting therapy for GCC agonists each month [8][9] - The company aims for Ibsrela to reach peak sales of $1 billion, with the potential to achieve this sooner than the previously projected timeline of 2033 [18][19] Market Dynamics - The first quarter typically sees a contraction in the IBS-C market due to insurance policy resets, which affects patient access and spending [7][8] - Despite the contraction, Ibsrela continues to gain traction, with positive feedback from physicians regarding its efficacy compared to GCC agonists [13][14] - The company is exploring additional indications for Ibsrela, such as Chronic Idiopathic Constipation (CIC), which has a larger patient population compared to IBS-C [24][28] Exposa Performance and Strategy - Exposa generated $25 million in revenue in Q1, with the company focusing on maintaining patient access rather than reimbursement issues [29][30] - The decision not to participate in the TDAPA process was made to ensure non-Medicare patients have access to Exposa, despite losing 60% of the total addressable market (TAM) due to changes in Medicare coverage [30][37] - The company is optimistic about Exposa's growth potential, targeting peak sales of $750 million by penetrating 30% of the 220,000 patients in the market [34][58] Regulatory and Legal Considerations - Ardelyx is currently appealing a CMS decision that classifies Exposa as a renal dialysis service, which could restore access for a significant portion of patients [53][57] - A favorable outcome from the appeal could increase the patient base by 60%, significantly impacting revenue potential [59][60] Business Development and Future Outlook - Ardelyx is actively seeking business development opportunities to expand its product portfolio, focusing on both GI and renal markets [63] - The company aims to build a sustainable enterprise by identifying and acquiring products that align with its strategic goals [64] Key Takeaways - Ardelyx is positioned for growth with its two commercial products, Ibsrela and Exposa, despite facing market challenges and regulatory hurdles - The company is optimistic about achieving its financial targets and expanding its market presence through strategic initiatives and potential new indications for its products