Financial Performance and Revenue Growth - Total revenue for Q2 2024 increased by 228% to $73.2 million compared to Q2 2023, driven by strong product sales[152] - Product sales for IBSRELA increased by 94% to $35.4 million in Q2 2024 compared to Q2 2023, driven by increased demand[153] - XPHOZAH contributed $37.1 million in product sales in Q2 2024, following its launch in Q4 2023[153] - Cost of product sales increased by $913 million (186%) for the three months and $1,554 million (180%) for the six months ended June 30, 2024, compared to the same periods in 2023, primarily due to increased net product sales of IBSRELA and XPHOZAH[157] - Other cost of revenue increased by $5,034 million (168%) for the three months and $9,984 million (240%) for the six months ended June 30, 2024, driven by increased payments to AstraZeneca under the AstraZeneca Termination Agreement[158] - Non-cash royalty revenue of $599,000 in Q2 2024 is attributable to royalties from Kyowa Kirin for sales of PHOZEVEL in Japan[155] Product Development and Approvals - IBSRELA, a first-in-class NHE3 inhibitor, was first sold in the U.S. in March 2022[124] - XPHOZAH, a phosphate absorption inhibitor, was approved by the U.S. FDA on October 17, 2023, and first sold in the U.S. in November 2023[126][127] - XPHOZAH was granted orphan drug designation by the U.S. FDA for pediatric hyperphosphatemia in November 2023[129] - XPHOZAH received FDA approval in October 2023, triggering a $3.0 million milestone payment received in Q1 2024[136] - Kyowa Kirin approved tenapanor for hyperphosphatemia in Japan, resulting in $30.0 million in milestone payments and an additional $5.0 million under the HCR Agreement, received in October 2023[177] Partnerships and Collaborations - Ardelyx has commercial agreements with Kyowa Kirin in Japan, Fosun Pharma in China, and Knight in Canada for tenapanor[130][131] - Knight paid Ardelyx a $2.3 million non-refundable payment in March 2018 and may pay up to CAD 22.2 million in milestones[132] - Kyowa Kirin paid Ardelyx $30.0 million upfront and may pay up to $55.0 million in milestones, with $35.0 million received as of June 30, 2024[133] - Fosun Pharma paid Ardelyx a $12.0 million upfront license fee and triggered a $2.0 million milestone payment in July 2023[135] - Fosun Pharma received approval for tenapanor in Hong Kong, potentially entitling the company to up to $113.0 million in milestones, with $8.0 million recognized as revenue by June 30, 2024[136] - The company received a $10.0 million upfront payment and a $5.0 million milestone payment from HCR under the HCR Agreement, recorded as a deferred royalty obligation[148] Financial Position and Cash Flow - Ardelyx's accumulated deficit as of June 30, 2024, is $889.2 million[121] - Cash and cash equivalents increased by $20,420 million (95%) to $41,890 million as of June 30, 2024, compared to December 31, 2023[172] - The company sold 16.8 million shares of common stock under the 2023 Open Market Sales Agreement, receiving gross proceeds of $70.0 million at a weighted average sales price of $4.17 per share[173] - The company entered into a Third Amendment to the 2022 Loan Agreement, allowing it to draw an additional $50.0 million of committed capital by March 15, 2024 (Term C Loan) and up to $50.0 million of uncommitted capital (Term D Loan), with the interest-only period extended to December 31, 2026[176] - The company's accumulated deficit as of June 30, 2024, is $889.2 million, with primary cash sources including stock sales, collaboration partnerships, and loan agreements[178] - Cash flow from operating activities decreased by $4.4 million (7%) in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to adjustments in net loss reconciliation and changes in operating assets and liabilities[185] - Cash flow from investing activities increased by $89.9 million (130%) in the six months ended June 30, 2024, compared to the same period in 2023, driven by the timing of investment maturities and purchases[186] - Cash flow from financing activities decreased by $7.9 million (13%) in the six months ended June 30, 2024, compared to the same period in 2023, largely due to the absence of proceeds from the 2021 Open Market Sales Agreement, offset by $49.8 million from the Term C Loan[187] - As of June 30, 2024, the company had $186.0 million in cash, cash equivalents, and short-term investments, consisting of bank deposits, money market funds, and high-quality fixed-income instruments[189] Operating Expenses and Costs - Total operating expenses increased by $41,948 million (118%) for the three months and $69,625 million (98%) for the six months ended June 30, 2024, compared to the same periods in 2023[160] - Research and development expenses increased by $4,480 million (54%) for the three months and $5,966 million (34%) for the six months ended June 30, 2024, primarily due to increased engagement with scientific communities and clinical trial activities[162] - Selling, general and administrative expenses increased by $37,468 million (138%) for the three months and $63,659 million (118%) for the six months ended June 30, 2024, driven by the commercialization of IBSRELA and XPHOZAH[163] - Interest expense increased by $2,251 million (209%) for the three months and $3,579 million (170%) for the six months ended June 30, 2024, due to a larger loan balance and higher variable interest rates[165] - Non-cash interest expense related to the sale of future royalties increased by $608 million (63%) for the three months and $1,341 million (69%) for the six months ended June 30, 2024[168] - Other income, net increased by $599 million (39%) for the three months and $1,636 million (57%) for the six months ended June 30, 2024, due to higher investment income[170] Market and Patient Data - Approximately 550,000 adult patients with CKD on dialysis in the U.S., with 80% treated with phosphate-lowering therapies[126] - 70% of patients treated with phosphate binders were unable to maintain phosphorus levels ≤5.5 mg/dL over six months[126] Royalties and Licensing Agreements - AstraZeneca is entitled to 10% royalties on net sales of tenapanor and 20% of non-royalty revenue, with $40.2 million recognized as other cost of revenue to date[143] - Non-cash royalty revenue of $599,000 in Q2 2024 is attributable to royalties from Kyowa Kirin for sales of PHOZEVEL in Japan[155] Inventory and Cost of Goods Sold - Cost of goods sold for Q2 2024 would have been $1.2 million higher if certain material and production costs had not been previously expensed[142] - The company had $19.6 million of inventory on hand as of June 30, 2024, previously expensed as R&D, which will not be reported as cost of goods sold in future periods[142] Loan Agreements and Interest Rates - The company's 2022 Loan Agreement bears interest at a floating rate of 7.95% plus the greater of 1.00% or 0.022% plus the 1-month CME Term SOFR rate, with a hypothetical 100 basis point increase in SOFR raising interest expense by $0.3 million for the six months ended June 30, 2024[190] Foreign Currency Risk - The company is exposed to foreign currency risk due to transactions denominated in Swiss francs and euros, though it does not use derivative financial instruments for speculative purposes[191] - The company had no open forward foreign currency exchange contracts as of June 30, 2024[192]

Exhibit 99.1 Ardelyx Reports Second Quarter 2024 Financial Results and Provides Business Update 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., August 1, 2024 - Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first- ...

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 ...

WALTHAM, Mass., July 31, 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 the publication of plain language summaries of results from two clinical trials on XPHOZAH® (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult pat ...

WALTHAM, Mass., July 31, 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 the publication of plain language summaries of results from two clinical trials on XPHOZAH® (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult pati ...

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 ...

WALTHAM, Mass., July 18, 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 it will hold a conference call on Thursday, August 1, 2024, at 4:30 p.m. Eastern Time to discuss financial results and provide a business update from the second quarter of 2024. To participate in the conference call, please dial (844) 481-2838 (do ...

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 ...