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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ardelyx Inc | NASDAQ:ARDX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
1.99 | 29.31% | 8.78 | 8.78 | 8.80 | 257,293 | 11:16:21 |
FREMONT, Calif. and WALTHAM, Mass., May 6, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business highlights and financial results for the first quarter ended March 31, 2021.
"We continue to prepare for the potential approval and launch of tenapanor following the recent extension of our PDUFA date to July 29, 2021," said Mike Raab, president and chief executive officer of Ardelyx. "We remain confident in the comprehensive data included in our New Drug Application and believe tenapanor represents an attractive alternative to currently available therapies to control serum phosphorus in CKD patients on dialysis. To that end, we are committed to working with the FDA through the completion of its review of our NDA and look forward to the possibility of making a significant impact in the lives of patients."
Recent Business and Pipeline Updates
First Quarter 2021 Financial Results
About Ardelyx, Inc.
Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2020. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.
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 statements regarding the potential for tenapanor to be approved for marketing by the FDA for the control of serum phosphorus in chronic kidney disease patients on dialysis. 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, the uncertainties associated with the regulatory approval process. 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 May 6, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc. Condensed Balance Sheets (In thousands)
| |||||||
March 31, 2021 | December 31, 2020 | ||||||
(Unaudited) | (1) | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 84,070 | $ | 91,032 | |||
Investments | 94,142 | 97,566 | |||||
Accounts receivable | 5,783 | — | |||||
Property and equipment, net | 2,292 | 1,936 | |||||
Right-of-use assets | 1,667 | 2,274 | |||||
Prepaid and other assets | 22,339 | 8,754 | |||||
Total assets | $ | 210,293 | $ | 201,562 | |||
Liabilities and stockholders' equity | |||||||
Accounts payable | $ | 5,378 | $ | 5,626 | |||
Accrued compensation and benefits | 4,348 | 5,672 | |||||
Current portion of operating lease liability | 1,412 | 2,117 | |||||
Loan payable, current portion | 16,667 | 4,167 | |||||
Deferred revenue | 5,670 | 4,177 | |||||
Accrued expenses and other liabilities | 11,262 | 6,657 | |||||
Operating lease liability, net of current portion | 397 | 413 | |||||
Loan payable, net of current portion | 34,348 | 46,621 | |||||
Stockholders' equity | 130,811 | 126,112 | |||||
Total liabilities and stockholders' equity | $ | 210,293 | $ | 201,562 | |||
(1) Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020. |
Ardelyx, Inc.
| |||||||
Three Months Ended March 31, | |||||||
2021 | 2020 | ||||||
Revenues: | |||||||
Collaborative development revenue | $ | 1,454 | $ | 1,175 | |||
Product supply revenue | 126 | 38 | |||||
Licensing revenue | 5,002 | — | |||||
Total revenues | 6,582 | 1,213 | |||||
Operating expenses: | |||||||
Cost of revenue | 1,000 | — | |||||
Research and development | 20,456 | 15,844 | |||||
General and administrative | 17,131 | 7,138 | |||||
Total operating expenses | 38,587 | 22,982 | |||||
Loss from operations | (32,005) | (21,769) | |||||
Interest expense | (1,100) | (1,357) | |||||
Other income (expense), net | (49) | 753 | |||||
Loss before provision for income taxes | (33,154) | (22,373) | |||||
Provision for income taxes | $ | 1 | $ | — | |||
Net loss | $ | (33,155) | $ | (22,373) | |||
Net loss per common share, basic and diluted | $ | (0.34) | $ | (0.25) | |||
Shares used in computing net loss per share - basic and diluted | 97,179,241 | 88,880,658 |
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SOURCE Ardelyx
Copyright 2021 PR Newswire
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