PR Newswire
FREMONT, Calif., May 8, 2018
FREMONT, Calif., May 8, 2018 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), today reported business highlights and financial results for the first quarter ended March 31, 2018.
"The first quarter of 2018 has been about execution for Ardelyx," said Mike Raab, president and chief executive officer of Ardelyx. "We are focused on enrolling our second Phase 3 study for tenapanor for hyperphosphatemia and investigating the potential of our RDX013 program for the treatment of hyperkalemia. In addition, our team is preparing the NDA submission for tenapanor for IBS-C, which, when submitted, will be a landmark milestone for our company. We now have three strategic collaborations in place that will enable us to bring tenapanor to patients in geographies outside of the U.S., positioning us to be able to meaningfully impact the care of many patients."
Recent Business and Pipeline Updates
Upcoming Digestive Disease Week Presentations
Ardelyx has been selected to give an oral presentation of its Phase 3 T3MPO-2 trial results for tenapanor for the treatment of IBS-C in the clinical sciences late-breaking plenary session. The company is also presenting three posters. Ardelyx will present preclinical data from the company's APECCS platform demonstrating tenpanor's pain mechanism, preclinical data from its RDX-023 FXR agonist program showing reduction in steatosis, inflammation and fibrosis in three mouse models of NASH, as well as preclinical data from the RDX-011 NHE3 program showing normalization of GI transit in models of opioid-induced constipation, multiple sclerosis and cystic fibrosis. Digestive Disease Week is being held June 2-5, 2018 in Washington D.C.
First Quarter 2018 Financial Results
About Ardelyx, Inc.
Ardelyx is focused on enhancing the way people with renal diseases are treated by developing first-in-class medicines. Ardelyx's renal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation and anticipates submitting a New Drug Application to the U.S. Food and Drug Administration for this indication in the second half of 2018. To efficiently bring its treatments to market, Ardelyx is pursing strategic collaborations in the U.S. and outside the U.S., with established agreements with Kyowa Hakko Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com/ and connect with us on Twitter @Ardelyx.
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 the potential for Ardelyx's product candidates in treating the diseases and conditions for which they are being developed; Ardelyx's expected timing for the filing of its NDA for tenapanor for the treatment of IBS-C, Ardelyx's expected timing to report topline data for its second Phase 3 clinical trial of tenapanor for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis, the potential for Ardelyx to receive milestone and royalty payments from Knight Therapeutics and Ardelyx's ability to establish collaborations in the future. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates or 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 inherent in research and the clinical development process, including 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2018, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc. | ||||
Condensed Consolidated Balance Sheets | ||||
(In thousands) | ||||
| ||||
| | March 31, 2018 | | December 31, |
| | (Unaudited) | | (1) |
Assets | | | | |
Cash and cash equivalents | | $ 67,745 | | $ 75,383 |
Short-term investments | | 59,704 | | 58,593 |
Accounts receivable | | — | | 10,796 |
Unbilled license revenue | | 5,000 | | — |
Property and equipment, net | | 7,358 | | 8,032 |
Prepaid and other assets | | 3,030 | | 5,099 |
Total assets | | $ 142,837 | | $ 157,903 |
| | | | |
Liabilities and stockholders' equity | | | | |
Accounts payable and other current liabilities | | $ 12,162 | | $ 17,871 |
Uncharged license fees | | 1,000 | | — |
Long-term liabilities | | 699 | | 720 |
Stockholders' equity | | 128,976 | | 139,312 |
Total liabilities and stockholders' equity | | $ 142,837 | | $ 157,903 |
|
(1) Derived from the audited consolidated financial statements included on Form 10-K for the year ended December 31, 2017. |
Ardelyx, Inc. | ||||
Condensed Consolidated Statements of Operations | ||||
(In thousands, except share and per share amounts) | ||||
| ||||
| Three Months Ended March 31, | |||
| 2018 | | 2017 | |
| (Unaudited) | | (Unaudited) | |
Revenue: | | | | |
Licensing revenue | $ 2,320 | | $ — | |
Cost of revenue | 464 | | — | |
Gross profit | 1,856 | | — | |
Operating expenses: | | | | |
Research and development | $ 13,350 | | $ 22,387 | |
General and administrative | 6,191 | | 6,047 | |
Total operating expenses | 19,541 | | 28,434 | |
Loss from operations | (17,685) | | (28,434) | |
Other income | 670 | | 426 | |
Provision for income taxes | (4) | | — | |
Net loss | $ (17,019) | | $ (28,008) | |
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