ATLANTA, Aug. 19, 2024 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX). The lawsuit alleges that Defendants indicated that Ardelyx would apply to include its product, XPHOZAH, in the Transitional Drug Add-on Payment Adjustment (“TDAPA”) when, in fact, Ardelyx had not yet reached a firm decision concerning whether or not to apply to include XPHOZAH in TDAPA, and could not, in fact, decide whether or not to submit such an applicat ...

Financial Data and Key Metrics Changes - The company reported significant year-over-year revenue growth in Q2 2024, totaling $73.2 million compared to $22.3 million in Q2 2023, reflecting strong performances from both IBSRELA and XPHOZAH [14][24] - Net product sales revenue for IBSRELA was $35.4 million, nearly doubling from $18.3 million in the same period last year, and showing a 25% quarter-over-quarter growth [17][18] - XPHOZAH reported $37.1 million in net product sales revenue for Q2 2024, up from $15.2 million in Q1 2024, indicating a 145% sequential growth [20][24] Business Line Data and Key Metrics Changes - IBSRELA's revenue growth was driven by strong volume growth and an increase in new and refill prescriptions, with a gross to net deduction improving from 33.5% in Q1 to 29.7% in Q2 [18][19] - XPHOZAH's gross to net deduction improved from 23.8% in Q1 to 21.4% in Q2, driven by strong demand from healthcare providers [21][24] Market Data and Key Metrics Changes - The company anticipates IBSRELA achieving at least a 10% share of the IBS prescription market and aims for it to become a $1 billion product before patent expiry [7] - The company is advocating for patient access to XPHOZAH, emphasizing the need for oral-only phosphate lowering therapies to remain outside the Medicare bundle [9][10] Company Strategy and Development Direction - The company is focused on maximizing patient access to XPHOZAH and has taken legal action against CMS regarding the inclusion of oral-only phosphate lowering therapies in the Medicare bundle [10][11] - The company plans to expand its sales team for IBSRELA, expecting this to impact growth positively in the second half of the year [19][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth momentum of both products and reiterated guidance for IBSRELA's full-year U.S. net product sales revenue to be between $140 million and $150 million [19][25] - The management highlighted the importance of advocacy for patient access to XPHOZAH and the ongoing efforts to address regulatory challenges [9][10] Other Important Information - The company ended Q2 2024 with a strong cash position of $186 million, slightly up from $184.3 million at the end of 2023, without engaging in fundraising activities during the quarter [24] - Research and development expenses increased to $12.8 million from $8.3 million in Q2 2023, reflecting expanded medical affairs teams [22] Q&A Session Summary Question: Insights on XPHOZAH sales and inventory - Management confirmed that both products have low inventory levels in the channel and that gross to net variability is primarily influenced by the commercial co-pay program [28][30] Question: Initiatives to keep XPHOZAH out of the CMS bundle - Management stated that it is premature to discuss specific initiatives but emphasized their commitment to exhausting all options for patient access [31][32] Question: Impact of new sales reps on IBSRELA performance - Management indicated that the full impact of the expanded sales force would be seen by the end of the month, with continued strong performance expected [38][39] Question: Breakdown of prescribers for XPHOZAH - Management noted that it is too early to determine the exact breakdown of prescribers but emphasized strong interest from physicians [55][56] Question: Contingency plans if XPHOZAH is included in the Medicare bundle - Management stated that it is premature to discuss contingency plans but expressed confidence in their ongoing efforts [64]

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]

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 ...

Ardelyx, Inc. (NASDAQ:ARDX) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Caitlin Lowie - Vice President of Corporate Communications & Investor Relations Mike Raab - President & Chief Executive Officer Susan Rodriguez - Chief Commercial Officer Justin Renz - Chief Financial Officer & Chief Operations Officer Conference Call Participants Chris Raymond - Piper Sandler Yigal Nochomovitz - Citi Louise Chen - Cantor Fitzgerald Ryan Deschner - Raymond James Dennis Ding - Jefferies R ...

Product Launch and Approval - Tenapanor, branded as IBSRELA, was first sold in the U.S. in March 2022, and XPHOZAH was first sold in November 2023[123][129]. - XPHOZAH received FDA approval on October 17, 2023, to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis[128]. - In November 2023, XPHOZAH was granted orphan drug designation by the U.S. FDA for the treatment of pediatric hyperphosphatemia[131]. Market Strategy - IBSRELA's market strategy targets approximately 9,000 high-writing healthcare providers who account for about 50% of IBS-C prescriptions[126]. - XPHOZAH's market strategy focuses on approximately 8,000 nephrology healthcare providers who write about 80% of phosphate-lowering therapy prescriptions[129]. - The company has established commercial agreements with Kyowa Kirin in Japan, Fosun Pharma in China, and Knight in Canada for tenapanor[134][132]. Financial Performance - Total revenue for the three months ended March 31, 2024, was $46.0 million, a 305% increase from $11.4 million in the same period in 2023[156]. - Net product sales for IBSRELA reached $28.4 million in Q1 2024, up from $11.4 million in Q1 2023, while XPHOZAH contributed $15.2 million in its first sales[158]. - Cost of goods sold for the three months ended March 31, 2024, was $7.1 million, a 364% increase from $1.5 million in Q1 2023[162]. Expenses and Losses - Research and development expenses for Q1 2024 were $10.6 million, a 16% increase from $9.1 million in Q1 2023[165]. - Selling, general and administrative expenses surged to $53.0 million in Q1 2024, a 98% increase from $26.8 million in Q1 2023[165]. - The company expects to continue incurring operating losses as it invests in the commercialization of IBSRELA and XPHOZAH[124]. Cash Flow and Liquidity - Cash and cash equivalents increased by 68% to $36,147 thousand as of March 31, 2024, from $21,470 thousand at the end of 2023[175]. - Total liquid funds reached approximately $202.6 million, reflecting a 10% increase from $184,299 thousand at the end of 2023[175]. - Net cash used in operating activities decreased by 20% to $(35,722) thousand for the three months ended March 31, 2024, compared to $(44,795) thousand in 2023[187]. Debt and Interest - Interest expense surged by 129% to $(2,356) thousand, compared to $(1,028) thousand in 2023, primarily due to a higher variable interest rate and an increased loan balance[170]. - Borrowings under the 2022 Loan Agreement bear a floating interest rate of 7.95% plus a variable component, with a potential increase in interest expense of approximately $0.2 million for a hypothetical 100 basis points rise in the one-month CME Term SOFR[194]. Risk Factors - The company is subject to foreign currency risk, primarily from transactions in Swiss francs and euros, but does not use derivatives for speculative trading purposes[195]. - As of March 31, 2024, there were no open forward foreign currency exchange contracts[196]. Internal Controls and Legal Proceedings - The company has evaluated the effectiveness of its disclosure controls and procedures, concluding they were effective as of March 31, 2024[197]. - There were no changes in internal control over financial reporting that materially affected the company during the three months ended March 31, 2024[198]. - As of March 31, 2024, there were no pending legal proceedings expected to materially affect the company's financial condition[202].

Exhibit 99.1 Ardelyx Reports First Quarter 2024 Financial Results and Provides Business Update Company reports $45.6 million in Q1 product-related revenue, including $28.4 million in net product sales revenue for IBSRELA and $15.2 million in net product sales revenue for XPHOZAH Company ends Q1 with approximately $203 million in cash and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., May 2, 2024 - Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a missio ...

Start Time: 16:30 January 1, 0000 5:21 PM ET Ardelyx, Inc. (NASDAQ:ARDX) Q4 2023 Earnings Conference Call February 22, 2024, 16:30 PM ET Company Participants Mike Raab - President and CEO Justin Renz - Chief Financial and Operations Officer Laura Williams - CMO Susan Rodriguez - Chief Commercial Officer Caitlin Lowie - VP of Corporate Communications and IR Conference Call Participants Dennis Ding - Jefferies Chris Raymond - Piper Sandler Laura Chico - Wedbush Louise Chen - Cantor Fitzgerald Yigal Nochomovit ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-K ____________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 OR o 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 001-36485 ___ ...