Revenue Performance - IBSRELA generated $35.4 million in net product sales revenue in Q2 2024, reflecting approximately 25% quarter-over-quarter growth compared to Q1 2024[3]. - XPHOZAH recorded $37.1 million in net product sales revenue in Q2 2024, showing significant growth from $15.2 million in Q1 2024[4]. - Total revenue for Q2 2024 was $73.2 million, compared to $22.3 million in Q2 2023, primarily driven by increased net product sales[8]. - The company expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 million and $150.0 million[4]. - Total revenues for Q2 2024 reached $73,222,000, a significant increase from $22,333,000 in Q2 2023, representing a growth of 228%[24]. - Product sales, net for IBSRELA amounted to $35,445,000 in Q2 2024, up from $18,309,000 in Q2 2023, reflecting a growth of 94%[24]. - XPHOZAH generated $37,146,000 in product sales for Q2 2024, with no sales reported in Q2 2023[24]. - Total product sales, net for the first half of 2024 reached $116,103,000, compared to $29,664,000 in the same period of 2023, marking a growth of 290%[24]. Expenses and Losses - Research and development expenses for Q2 2024 were $12.8 million, up from $8.3 million in Q2 2023[9]. - Selling, general and administrative expenses increased to $64.7 million in Q2 2024, compared to $27.2 million in Q2 2023, primarily due to commercialization efforts[9]. - The net loss for Q2 2024 was $16.5 million, or $(0.07) per share, compared to a net loss of $17.1 million, or $(0.08) per share, in Q2 2023[9]. - Operating expenses for Q2 2024 totaled $77,416,000, up from $35,468,000 in Q2 2023, indicating a rise of 118%[24]. - The net loss for Q2 2024 was $16,454,000, slightly improved from a net loss of $17,121,000 in Q2 2023[24]. Financial Position - As of June 30, 2024, the company had approximately $186 million in cash and investments, up from $184.3 million at the end of 2023[7]. - Cash and cash equivalents increased to $41,890,000 as of June 30, 2024, compared to $21,470,000 at the end of 2023, showing a growth of 95%[22]. - Long-term debt rose to $100,249,000 as of June 30, 2024, up from $49,822,000 at the end of 2023, reflecting an increase of 101%[22]. - Total assets increased to $343,488,000 as of June 30, 2024, compared to $297,579,000 at the end of 2023, representing a growth of 15%[22]. - Stockholders' equity decreased to $146,990,000 as of June 30, 2024, down from $166,816,000 at the end of 2023, a decline of 12%[22]. Strategic Initiatives - The company is actively working to protect patient access to XPHOZAH amid proposed CMS policy changes that could restrict its use[5]. - Ardelyx continues to expand its sales team to support the growth trajectory of IBSRELA and XPHOZAH[3].

IBSRELA generates $35.4 million in net product sales revenue XPHOZAH generates $37.1 million in net product sales revenue Company ends Q2 with approximately $186 million in cash and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Aug. 01, 2024 (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 reported fin ...

Core Insights - Ardelyx, Inc. has published plain language summaries of clinical trial results for XPHOZAH® (tenapanor), aimed at helping patients with chronic kidney disease (CKD) on dialysis understand safety and efficacy data [1][3] - XPHOZAH is the first and only phosphate absorption inhibitor approved by the FDA for reducing serum phosphorus in adults with CKD on dialysis [2][12] - The NORMALIZE and OPTIMIZE studies provide insights into the effectiveness of XPHOZAH in managing hyperphosphatemia in CKD patients [5][6][7] Company Overview - Ardelyx is focused on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [1][13] - The company has two commercial products approved in the U.S.: IBSRELA® and XPHOZAH® [13] Product Information - XPHOZAH works by blocking phosphate absorption in the gut, specifically targeting the sodium hydrogen exchanger 3 (NHE3) [4] - It is administered as a single tablet taken twice daily, with diarrhea being the most common side effect reported in clinical trials [4][11] Clinical Trials - The NORMALIZE study is an 18-month extension study evaluating the ability of XPHOZAH to maintain normal serum phosphate levels in patients with CKD on dialysis [5] - The OPTIMIZE study involved 330 patients and assessed different methods of initiating XPHOZAH for phosphorus management [6][7] Medical Context - Hyperphosphatemia is a prevalent condition among the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [8]

Biotech stocks are known for their high volatility and potential for massive gains. The success in the sector often hinges on progressive and often groundbreaking medical advancements. Any concerns relating to upcoming drugs can have severely negative effects on stock prices.As per Precedence Research, the global biotechnology market is projected to grow from $1.38 trillion in 2023 to approximately $4.25 trillion by 2033. The expected growth is largely to be driven by advancements in various biotechnologica ...

The market expects Ardelyx (ARDX) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on August 1, 2024, might help the stock move higher if these key numbers are better ...

Lawsuit challenges CMS’s statutory overreach in its determination to include oral-only phosphate-lowering therapies in the End-Stage Renal Disease Prospective Payment System Inclusion of oral-only phosphate lowering therapies within the ESRD PPS limits patient choice and timely access to important innovations and treatment options for unmet needs WALTHAM, Mass., July 17, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commerc ...

Alexyz3d/iStock via Getty ImagesShares of Ardelyx (NASDAQ:ARDX) took a hit last week after the company said it will not apply to include Xphozah in the Centers for Medicare & Medicaid Services (‘CMS’) End-Stage Renal Disease (‘ESRD’) Prospective Payment System (‘PPS’) Transitional Drug Add-On Payment Adjustment (‘TDAPA’), in an effort to preserve patient access to the drug. This effectively means CMS will not cover Xphozah in 2025, and the drug’s future is highly uncertain. After last week’s decision no ...

MONSEY, N.Y., July 02, 2024 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating whether Ardelyx, Inc. (Nasdaq: ARDX) (“Ardelyx”) has violated the federal securities laws after the company announced that it had decided not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA). Upon this news, Ardelyx shares have so far fallen nearly 30% in tradin ...

Ardelyx continues support for bipartisan legislation that would extend the exclusion of oral-only medications from entering the CMS Prospective Payment System Conference call scheduled for 8:00 AM Eastern Time WALTHAM, Mass., July 02, 2024 (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, in an effort to preserve patie ...

Ardelyx continues support for bipartisan legislation that would extend the exclusion of oral-only medications from entering the CMS Prospective Payment System Conference call scheduled for 8:00 AM Eastern Time WALTHAM, Mass., July 02, 2024 (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, in an effort to preserve patien ...