Summary of Ardelyx (ARDX) Conference Call - September 03, 2025 Company Overview - **Company**: Ardelyx, Inc. (ARDX) - **Products**: Exposa and Ibsrela - **Market Focus**: Biopharmaceuticals, specifically in the treatment of IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. Key Points Business Strategy and Growth - **Decision on TDAPA**: The company chose not to participate in the TDAPA program, which has led to month-over-month growth in prescriptions since February 2025, indicating a successful strategy [3][4]. - **Prescription Growth**: Total prescriptions, including patient assistance and commercial, have exceeded previous months, although growth is not as fast as desired due to turmoil in the dialysis community [3][4]. - **Ibsrela's Potential**: The company is optimistic about Ibsrela becoming a billion-dollar drug, with a confident target of $750 million for Exposa [5][24]. Market Dynamics - **IBS-C Market**: The IBS-C market has grown by more than double digits over the past few years, with Ibsrela contributing to this growth. Only 25% of patients are satisfied with current treatments, indicating a significant opportunity for Ibsrela [7][8]. - **Patient Identification**: The company utilizes a Salesforce and omnichannel marketing to raise awareness among both patients and physicians about Ibsrela [9][10]. - **First-Line Utilization**: There is some first-line utilization of Ibsrela as physicians gain confidence, although the product is typically positioned after secretagogues [14][15]. Financial Guidance - **Revenue Guidance**: The company raised its guidance for Ibsrela from $240-$250 million to $250-$260 million for the year, reflecting strong momentum [41][24]. - **Market Size for Exposa**: The total addressable market (TAM) for Exposa is estimated at 220,000 patients, with a need for only 60,000 patients to reach the $750 million revenue target [66]. Competitive Landscape - **Competitors**: Exposa is positioned as an add-on therapy for patients who cannot tolerate binders, with a focus on improving patient outcomes in hyperphosphatemia management [73][74]. - **Market Positioning**: The company emphasizes that hyperphosphatemia is poorly treated with current options, and Exposa offers a different mechanism of action that can help more patients reach treatment goals [74][75]. Regulatory and Market Challenges - **Pediatric Indication**: The company is committed to pediatric studies as part of its obligations to the FDA [20]. - **Market Access**: The company is actively working on strategies to ensure patient access to Exposa, despite challenges in the retail pharmacy landscape [31][63]. - **Legal Challenges**: The company is involved in legal proceedings regarding CMS regulations, arguing that CMS overstepped its authority in defining dialysis services [90][91]. Future Outlook - **Long-Term Goals**: The company aims to achieve its billion-dollar revenue target for Ibsrela before the loss of exclusivity (LOE) for its products, which is set for April 2034 for Exposa [81][84]. - **Market Expansion**: Ardelyx is exploring additional therapeutic areas and potential partnerships to expand its portfolio, while being cautious about market dynamics and regulatory changes [88][89]. Additional Insights - **Patient Engagement**: The company recognizes the importance of engaging patients to drive awareness and demand for Ibsrela, with plans to enhance marketing efforts in social media and other channels [35][36]. - **Real-World Evidence**: Ardelyx is conducting ongoing real-world evidence studies to assess the effectiveness of Exposa, with results expected later this year [75]. This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting Ardelyx's growth potential, market challenges, and future plans.

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

Financial Data and Key Metrics Changes - The company reported total revenues of $74.1 million for Q1 2025, a 61% increase compared to $46 million in Q1 2024 [19] - Net sales revenue for IBSRELA was $44.4 million, reflecting a 57% increase year-over-year [19] - Exposa generated net sales revenue of $23.4 million, up approximately 55% from $15.2 million in the same quarter last year [19][21] - The company recorded a net loss of approximately $41.1 million or $0.17 per share, compared to a net loss of $26.5 million or $0.11 per share in the prior year [23] Business Line Data and Key Metrics Changes - IBSRELA experienced strong prescription demand, with one of the highest prescription demand quarters to date [6] - Exposa grew by 30% year-over-year when excluding a one-time gross to net adjustment for return reserve release [7][21] - The gross to net deduction for IBSRELA was 34.8%, expected to improve throughout the year [20] Market Data and Key Metrics Changes - The IBS C market traditionally contracts in Q1, which was observed this year, but the company remains optimistic about recovery in subsequent quarters [31] - The dialysis market is undergoing significant disruption due to the loss of Medicare Part D coverage for phosphate-lowering therapies, impacting Exposa's market dynamics [8] Company Strategy and Development Direction - The company is focused on driving strong commercial execution for IBSRELA and navigating access complexities for Exposa [10] - The strategic imperatives include raising awareness of IBSRELA and positioning it as a first-line treatment for appropriate patients [13] - The company aims to achieve peak annual net sales revenue of over $1 billion for IBSRELA and $750 million for Exposa [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of IBSRELA and Exposa, citing strong patient demand and effective commercial strategies [5][10] - The company is closely monitoring market dynamics and will provide further updates as the landscape evolves [9] - Management remains committed to building long-term value for shareholders despite current market challenges [10] Other Important Information - The company received a $5 million milestone payment from a partner in China following the approval of a cannabinoid for hyperphosphatemia [22] - Research and development expenses increased to $14.9 million, reflecting greater engagement with scientific and medical communities [22] Q&A Session Summary Question: Expectations for the IBS C market improvement in Q2 - Management expects the IBS C market to improve as the year progresses, based on strong prescription demand observed in Q1 [31][32] Question: Details on the return reserve and its impact - The return reserve was deemed unnecessary due to zero returns and limited bottles in distribution, leading to modest improvements in gross to net going forward [29][30] Question: Insights on the Q1 contraction and its differences from previous years - The contraction is consistent with historical trends, but the company remains optimistic about future growth [35][37] Question: Long-term gross to net targets and updates on the China launch - Long-term guidance for gross to net is expected to be around 30% plus or minus 5% [40] Question: Discrepancies between reported revenue and script data for IBSRELA - Management acknowledged fluctuations in scripts and emphasized the importance of focusing on guidance rather than individual quarter performance [48][50] Question: Metrics for assessing the expanded field force's impact - Key metrics include increases in activity, new riders, and new/refill prescriptions, all of which showed positive trends in Q1 [56][57] Question: Updates on the Kidney Patient Act and potential external asset acquisitions - The Kidney Patient Act is viewed as a call option, and the company is actively pursuing external assets in renal and GI spaces [102][104]