Revenue Performance - Total revenues for Q1 2025 reached $74.1 million, a 61% increase from $46.0 million in Q1 2024[79] - Product sales, net for IBSRELA were $44.4 million, up 57% from $28.4 million in Q1 2024, while XPHOZAH sales were $23.4 million, a 55% increase from $15.2 million[79] - The gross product sales for Q1 2025 were $96.7 million, a 55% increase from $62.5 million in Q1 2024, with GTN adjustments totaling $28.9 million[85] - Licensing revenue increased significantly to $5.0 million in Q1 2025, compared to $17,000 in Q1 2024, primarily due to a $5.0 million milestone from the Fosun Agreement[83] - The company received a $5.0 million milestone payment in Q1 2025 following the NDA approval for tenapanor in China, recorded as licensing revenue[77] Operating Expenses - Total operating expenses rose to $98.2 million in Q1 2025, a 54% increase from $63.6 million in Q1 2024, driven by higher selling, general, and administrative costs[87] - Research and development expenses increased by 41% to $14.9 million in Q1 2025, up from $10.6 million in Q1 2024, largely due to increased employee-related expenses[90] - Cost of goods sold for Q1 2025 was $12.3 million, a 73% increase from $7.1 million in Q1 2024, reflecting higher product sales[87] - The increase in selling, general, and administrative expenses was attributed to commercialization efforts for IBSRELA and XPHOZAH, including a $2.8 million rise in stock-based compensation[91] Cash Flow and Liquidity - As of March 31, 2025, the company had cash and cash equivalents of $30.8 million, down 53% from $64.9 million on December 31, 2024[95] - Total liquid funds decreased by 14% to $214.0 million from $250.1 million[95] - Net cash used in operating activities increased by 8% to $38.5 million in Q1 2025 compared to $35.7 million in Q1 2024[100] - Net cash provided by financing activities decreased by 97% to $1.5 million in Q1 2025 from $53.0 million in Q1 2024[100] - The company has drawn $150.0 million from a total of $200.0 million available under the 2022 Loan Agreement as of March 31, 2025[97] - The company reported a net decrease in cash and cash equivalents of $34.1 million in Q1 2025, compared to an increase of $14.7 million in Q1 2024[100] - The company expects its available cash and short-term investments will be sufficient to fund operations for at least one year from the issuance of the financial statements[98] Interest Expense - Interest expense increased to $4.2 million in Q1 2025, up 78% from $2.4 million in Q1 2024, due to a higher loan balance from the Term D Loan[92] - A hypothetical increase in one-month CME Term SOFR of 100 basis points would increase interest expense by approximately $0.4 million for Q1 2025[106] Share Issuance - The company completed sales resulting in the issuance of 16.8 million shares and gross proceeds of $70.0 million at an average price of approximately $4.17[96] Investment Strategy - The company maintains its excess cash in high-quality, short-term investments, minimizing exposure to interest rate risk[105]

Revenue Performance - Ardelyx reported total revenue of $74.1 million for Q1 2025, reflecting a 61% year-over-year growth[2] - IBSRELA net product sales revenue reached $44.4 million in Q1 2025, showing a significant year-over-year growth of approximately 57%[5] - XPHOZAH net product sales revenue was $23.4 million in Q1 2025, with a 30% growth compared to the same period in 2024, excluding a $3.8 million release of prior periods' estimated product returns[6] - Total revenues for the three months ended March 31, 2025, were $74,114 million, a 61.1% increase from $46,023 million in the same period of 2024[27] - Total product sales, net, reached $67,814 million, up 55.8% from $43,512 million year-over-year[27] - Licensing revenue surged to $5,020 million, compared to just $17 million in the same quarter of 2024[27] Financial Position - The company ended Q1 2025 with $214.0 million in cash, cash equivalents, and investments, down from $250.1 million at the end of 2024[8] Sales Forecast - Ardelyx expects full-year 2025 U.S. net product sales revenue for IBSRELA to be between $240.0 million and $250.0 million[5] Expenses - Research and development expenses for Q1 2025 were $14.9 million, up from $10.6 million in Q1 2024, reflecting increased engagement with the scientific community[12] - Selling, general and administrative expenses rose to $83.2 million in Q1 2025, compared to $53.0 million in Q1 2024, primarily due to commercialization costs[12] - Research and development expenses increased to $14,938 million, a 41.1% rise compared to $10,579 million in the prior year[27] - Selling, general and administrative expenses rose significantly to $83,222 million, up 57.5% from $52,994 million in the previous year[27] - Total cost of goods sold was $12,303 million, up from $7,128 million, reflecting a 72.5% increase year-over-year[27] Net Loss - The net loss for Q1 2025 was $41.1 million, or $(0.17) per share, compared to a net loss of $26.5 million, or $(0.11) per share, in Q1 2024[12] - The net loss for the quarter was $41,144 million, compared to a net loss of $26,518 million in the same quarter of 2024[27] - Net loss per share of common stock was $0.17, compared to $0.11 in the prior year[27] - The company reported a loss from operations of $36,349 million, an increase from a loss of $24,678 million in the same period last year[27] Leadership Changes - Ardelyx appointed Merdad Parsey, M.D. Ph.D., to its Board of Directors and Laura A. Williams, M.D., M.P.H., as the first Chief Patient Officer in April 2025[8] Milestone Payment - The company received a $5.0 million milestone payment from Fosun Pharma following the approval of tenapanor in China for hyperphosphatemia[8]

Financial Performance - Company reported total revenue of $74.1 million for Q1 2025, reflecting a 61% increase year-over-year from $46.0 million in Q1 2024 [9][30] - IBSRELA net product sales revenue was $44.4 million, showing a significant year-over-year growth of approximately 57% from $28.4 million in Q1 2024 [4][9] - XPHOZAH net product sales revenue reached $23.4 million, which is a 54% increase from $15.2 million in Q1 2024 [5][9] - Company ended Q1 2025 with $214.0 million in cash, cash equivalents, and investments, down from $250.1 million at the end of 2024 [7] Strategic Focus - Company aims to accelerate commercial growth for IBSRELA and deepen the adoption of XPHOZAH while building a pipeline of innovative therapies [3] - Management emphasizes maintaining disciplined financial performance to support long-term potential and value creation [3] Corporate Developments - In April 2025, company appointed Merdad Parsey, M.D. Ph.D., to its Board of Directors and Laura A. Williams, M.D., M.P.H., as the first Chief Patient Officer [8] - Company received a $5.0 million milestone payment from Fosun Pharma following the approval of tenapanor in China for hyperphosphatemia [10] Operating Expenses - Research and development expenses for Q1 2025 were $14.9 million, up from $10.6 million in Q1 2024 [14] - Selling, general and administrative expenses increased to $83.2 million from $53.0 million in the same period last year, primarily due to commercialization costs [14] Net Loss - Company reported a net loss of $41.1 million for Q1 2025, compared to a net loss of $26.5 million in Q1 2024 [14][30] - Net loss per share was $(0.17) for Q1 2025, compared to $(0.11) for Q1 2024 [30]

Core Insights - Ardelyx, Inc. has appointed Merdad Parsey, M.D., Ph.D. to its board of directors, enhancing its leadership team with a veteran biotech expert [1][2] Company Overview - Ardelyx is focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [4] - The company has two commercial products approved in the U.S.: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), along with early-stage pipeline candidates [4] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [4] Leadership Experience - Dr. Parsey brings over 25 years of experience in the pharmaceutical and biopharma industries, having held various clinical development and leadership roles [2][3] - His recent position was Chief Medical Officer at Gilead Sciences from 2019 until his retirement in 2025 [2] - Dr. Parsey has also served in senior roles at Genentech and as CEO of 3-V Biosciences, contributing to his extensive expertise in clinical strategy and development [2] Educational Background - Dr. Parsey holds a B.S. in microbiology and biochemistry, an M.D., and a Ph.D. in immunology from the University of Maryland [3] - He completed his internal medicine residency at Stanford University and a fellowship in pulmonary and critical care at the University of Colorado [3]

WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first- in-class medicines that meet significant unmet medical needs, today announced that the company will present data supporting the company's first-in-class retainagogue, IBSRELA (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be he ...

Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [3] - The company has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] Upcoming Events - Ardelyx will hold a conference call on May 1, 2025, at 4:30 p.m. Eastern Time to discuss financial results and provide a business update for the first quarter of 2025 [1] - Participants can join the call by dialing (877) 346-6112 for domestic calls or (848) 280-6350 for international calls [2] - The conference call will be available via live audio webcast on the company's website and will be archived for 30 days [2]

Core Insights - Ardelyx, Inc. announced a post-hoc analysis of the OPTIMIZE Study for XPHOZAH at the NKF Spring Clinical Meetings, highlighting the importance of understanding patient experiences and optimizing treatment adherence [1][4] - XPHOZAH is the first phosphate absorption inhibitor approved by the FDA for adults with chronic kidney disease on dialysis, providing a unique mechanism of action to reduce serum phosphorus levels [2][12] - The OPTIMIZE Study involved 330 patients and aimed to evaluate phosphorus management methods with XPHOZAH in both binder-naïve and binder-treated patients [3] Company Overview - Ardelyx is focused on developing innovative, first-in-class medicines to address significant unmet medical needs, with two commercial products, IBSRELA and XPHOZAH, approved in the U.S. [13] - The company is also engaged in international collaborations for the commercialization of tenapanor, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China [13] Product Details - XPHOZAH (tenapanor) is administered as a single tablet taken twice daily and works by inhibiting the sodium hydrogen exchanger 3 (NHE3) to reduce phosphate absorption [7][12] - Diarrhea is the most common side effect, reported in 43-53% of patients, with severe cases occurring in 5% of treated patients [11] Clinical Insights - The analysis presented at the NKF Spring Clinical Meetings indicated that among patients experiencing diarrhea, those using the anti-diarrheal medication loperamide had a lower discontinuation rate of 9.7% compared to 24.6% for those not using it [4] - The poster presentation titled "Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency" provided insights into managing diarrhea associated with tenapanor treatment [4][5] Industry Context - Hyperphosphatemia is a prevalent condition among the 550,000 patients in the U.S. with chronic kidney disease on dialysis, necessitating effective management strategies [8] - Current treatment guidelines recommend lowering elevated phosphate levels to the normal range of 2.5-4.5 mg/dL [9]

Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][12] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, both containing the active ingredient tenapanor [12] Product Information - XPHOZAH (tenapanor) is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. FDA for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis [2][11] - It is indicated as add-on therapy for patients who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy [11] - XPHOZAH operates through a unique mechanism that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily [2][6] Clinical Study Insights - The OPTIMIZE Study was a randomized, open-label trial involving 330 patients with CKD on dialysis and hyperphosphatemia, aimed at evaluating methods for initiating XPHOZAH to optimize phosphorus management [3] - A post-hoc analysis of this study has been accepted for presentation at the National Kidney Foundation Spring Clinical Meetings [1][4] Safety and Efficacy - Diarrhea was the most common side effect reported in clinical trials, occurring in 43-53% of patients, with severe diarrhea reported in 5% of patients [10] - The majority of diarrhea events were mild-to-moderate and typically resolved over time or with dose reduction [10] Industry Context - Hyperphosphatemia is a serious condition affecting the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [7] - The KDIGO treatment guidelines recommend lowering elevated phosphate levels toward the normal range of 2.5-4.5 mg/dL [7]

Core Points - Ardelyx, Inc. announced the establishment of the Derek Forfang Patient Advocate Award to honor leaders in chronic kidney disease advocacy on World Kidney Day [1][2] - The award is named after Derek Forfang, who passed away in 2023 due to chronic kidney disease and was known for his advocacy efforts [2] - The first recipients of the award are Mary Baliker, Erich Ditschman, Nichole Jefferson, Curtis Warfield, and David M. White, recognized for their contributions to the CKD community [1][3] Ardelyx Overview - Ardelyx is a biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for unmet medical needs [1][9] - The company has two commercial products approved in the U.S.: IBSRELA (tenapanor) and XPHOZAH (tenapanor) [9] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships in Japan and China [9] Award Recipients - **Mary Baliker**: A healthcare advocate for 40 years, diagnosed with a rare kidney disease at age nine, and author of a book aimed at helping children with chronic illnesses [4] - **Erich Ditschman**: Advocated for kidney patients, focusing on mentorship and policy change, and co-founded a home hemodialysis database [5] - **Nichole Jefferson**: A kidney transplant recipient advocating for health equity and early detection, focusing on underserved communities [6] - **Curtis Warfield**: A kidney transplant recipient advocating for health equity and policy reform, recognized for his advocacy efforts [7] - **David M. White**: A kidney transplant recipient focused on health equity and patient empowerment, collaborating with various organizations for systemic reform [8]

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