WALTHAM, Mass., Oct. 31, 2023 (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 financial results for the third quarter ended September 30, 2023 and provided a business update.
“Ardelyx is effectively advancing on all fronts with clear focus, evidenced by the continued strong performance of IBSRELA as well as the approval and commercial launch of XPHOZAH,” said Mike Raab, president and chief executive officer. “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue. We continue to see an increase in new and repeat writers, as well as new and refill prescriptions increasing from established writers at a steady, meaningful trajectory. We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients. In addition, on October 17, we received our long sought after FDA approval of XPHOZAH. Our team is in the field and launch is underway. We anticipate having product in channel in early November.”
IBSRELA® (tenapanor) growth continued with $22.3 million in U.S. net sales revenue in Q3 2023
Revenue for Ardelyx’s first commercialized product, IBSRELA, continued a persistent growth pattern. Driven by increased demand for IBSRELA, the company reported net sales revenue of $22.3 million in the third quarter, 22 percent quarter-over-quarter growth compared to the second quarter of 2023.
XPHOZAH® (tenapanor) received FDA approval on Oct. 17, 2023
On October 17, 2023, Ardelyx announced that the U.S. Food and Drug Administration (FDA) approved XPHOZAH to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. Following approval, the company began commercial launch activities as well as final supply and distribution activities. The company currently expects to have XPHOZAH available in early November.
Other Corporate Developments
Third Quarter 2023 Financial Results
Financial Guidance
Ardelyx currently expects full-year 2023 U.S. net product revenue for IBSRELA to be between $76.0 and $78.0 million.
Conference Call Details
The company will host a conference call today, October 31, 2023, at 8:00 AM ET to discuss these results. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for 30 days following the call.
IMPORTANT SAFETY INFORMATION (IBSRELA)
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Please see full Prescribing Information, including Boxed Warning, for additional risk information.
IMPORTANT SAFETY INFORMATION (XPHOZAH)
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing Information.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) as well as early-stage pipeline candidates. Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin has received approval for PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s expectation regarding opportunities for continued IBSRELA adoption, Ardelyx’s current expectation of timing for the commercial launch of XPHOZAH; the timing and receipt of the milestone payment from Fosun Pharma that was earned upon the U.S. FDA approval of XPHOZAH; and projected net product revenue for IBSRELA for full year 2023. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contacts:
Caitlin Lowie
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Kimia Keshtbod
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Ardelyx, Inc. | ||||||
Condensed Balance Sheets | ||||||
(In thousands) | ||||||
September 30, 2023 | December 31, 2022 | |||||
(Unaudited) | (1) | |||||
Assets | ||||||
Cash and cash equivalents | $ | 33,767 | $ | 96,140 | ||
Investments | 131,313 | 27,769 | ||||
Accounts receivable | 43,263 | 7,733 | ||||
Prepaid commercial manufacturing | 17,176 | 13,567 | ||||
Inventory, current | 8,524 | 3,282 | ||||
Inventory, non-current | 38,974 | 25,064 | ||||
Property and equipment, net | 1,116 | 1,223 | ||||
Right-of-use assets | 6,523 | 9,295 | ||||
Prepaid and other assets | 8,723 | 5,993 | ||||
Total assets | $ | 289,379 | $ | 190,066 | ||
Liabilities and stockholders' equity | ||||||
Accounts payable | $ | 7,736 | $ | 10,859 | ||
Accrued compensation and benefits | 8,357 | 7,548 | ||||
Current portion of operating lease liability | 4,321 | 3,894 | ||||
Current portion of long-term debt | — | 26,711 | ||||
Deferred revenue | 14,362 | 13,236 | ||||
Accrued expenses and other liabilities | 19,213 | 12,380 | ||||
Operating lease liability, net of current portion | 2,887 | 5,855 | ||||
Long-term debt, net of current portion | 27,229 | — | ||||
Deferred royalty obligation related to the sale of future royalties | 14,113 | 11,254 | ||||
Stockholders' equity | 191,161 | 98,329 | ||||
Total liabilities and stockholders' equity | $ | 289,379 | $ | 190,066 | ||
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Ardelyx, Inc. | |||||||||||||||
Condensed Statements of Operations | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 22,285 | $ | 4,885 | $ | 51,949 | $ | 6,899 | |||||||
Product supply revenue | 2,092 | 92 | 5,354 | 1,058 | |||||||||||
Licensing revenue | 32,014 | 9 | 32,790 | 23 | |||||||||||
Total revenues | 56,391 | 4,986 | 90,093 | 7,980 | |||||||||||
Cost of goods sold: | |||||||||||||||
Cost of sales | 644 | 230 | 1,508 | 287 | |||||||||||
Other cost of revenue | 7,048 | 502 | 11,210 | 668 | |||||||||||
Total cost of goods sold | 7,692 | 732 | 12,718 | 955 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 8,637 | 7,467 | 26,012 | 26,059 | |||||||||||
Selling, general and administrative | 32,664 | 18,667 | 86,653 | 56,868 | |||||||||||
Total operating expenses | 41,301 | 26,134 | 112,665 | 82,927 | |||||||||||
Income (loss) from operations | 7,398 | (21,880 | ) | (35,290 | ) | (75,902 | ) | ||||||||
Interest expense | (1,107 | ) | (886 | ) | (3,210 | ) | (2,409 | ) | |||||||
Non-cash interest expense related to the sale of future royalties | (922 | ) | (831 | ) | (2,859 | ) | (841 | ) | |||||||
Other income, net | 1,460 | 704 | 4,308 | 1,258 | |||||||||||
Income (loss) before provision for income taxes | 6,829 | (22,893 | ) | (37,051 | ) | (77,894 | ) | ||||||||
Provision for income taxes | 200 | — | 214 | 8 | |||||||||||
Net income (loss) | $ | 6,629 | $ | (22,893 | ) | $ | (37,265 | ) | $ | (77,902 | ) | ||||
Net income (loss) per share of common stock - basic and diluted | $ | 0.03 | $ | (0.14 | ) | $ | (0.17 | ) | $ | (0.53 | ) | ||||
Shares used in computing net income (loss) per share - basic | 222,782,229 | 165,104,789 | 214,976,555 | 147,319,818 | |||||||||||
Shares used in computing net income (loss) per share - diluted | 227,894,335 | 165,104,789 | 214,976,555 | 147,319,818 |
Last Trade: | US$5.60 |
Daily Change: | -0.17 -2.95 |
Daily Volume: | 2,085,213 |
Market Cap: | US$1.320B |
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