Full Press Release Details
Ardelyx Reports Second Quarter 2018 Financial Results and Recent Highlights
Operating Runway Extended to Mid 2020
Preparing to Submit NDA for Tenapanor in IBS-C in Early Q4 2018
Conference Call to be Held Today at 4:30 p.m. ET
FREMONT, Calif., Aug. 7, 2018 -- Ardelyx, Inc. (NASDAQ: ARDX), today reported business highlights and financial results for the second quarter ended June 30, 2018.
Our focus during the first half of 2018 has been on execution as we work to bring to market first-in-class medicines for renal diseases, said Mike Raab, president and chief executive officer of Ardelyx. "The PHREEDOM Trial, our second Phase 3 study for tenapanor for hyperphosphatemia, is underway and we are on track for data in 2019. If positive, tenapanor could be the first small molecule drug on the market for hyperphosphatemia in dialysis patients with a new, innovative mechanism. We have also advanced our RDX013 program for hyperkalemia and continue to make progress toward initiating clinical development in 2019. Before those important events, we plan to submit our first NDA for tenapanor for IBS-C early in the fourth quarter of this year, a landmark milestone for Ardelyx. With a healthy balance sheet, we are well positioned to achieve both our near and longer-term objectives.
Business and Pipeline Updates
Second Quarter 2018 Financial Results
Conference Call Information
The company will host a conference call today, August 7, 2018, at 4:30 p.m. ET. To participate in the conference call, please dial (855) 296 9612 (toll-free) or (920) 663 6277 (toll) and reference call ID number 1592643. A webcast of the call can be accessed by visiting the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the call.
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 early in the fourth quarter of 2018. To efficiently bring its treatments to market, Ardelyx is pursuing 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, Ardelyx's expected timing for the filing of its NDA for tenapanor for the treatment of hyperphosphatemia, Ardelyx's expected timing for the commencement of clinical development for its RDX013 program, and Ardelyx's expectations regarding the exhaustion of its current capital resources. 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 Quarterly Report on Form 10 Q filed with the Securities and Exchange Commission on August 7, 2018, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Monique Allaire, THRUST Strategic Communications
Consolidated Condensed Balance Sheets
| June 30, 2018 | December 31, 2017 | ||||||
| (Unaudited) | (1) | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 91,751 | $ | 75,383 | |||
| Short-term investments | 120,980 | 58,593 | |||||
| Accounts receivable | 30 | 10,796 | |||||
| Unbilled license revenue | 5,000 | ||||||
| Property and equipment, net | 6,689 | 8,032 | |||||
| Prepaid and other assets | 4,086 | 5,099 | |||||
| Total Assets | $ | 228,536 | $ | 157,903 | |||
| Liabilities and stockholders' equity | |||||||
| Accounts payable and other current liabilities | $ | 14,609 | $ | 17,871 | |||
| Uncharged license fees | 1,000 | ||||||
| Loan payable, long term | 48,836 | ||||||
| Other long-term liabilities | 677 | 720 | |||||
| Stockholders' equity | 163,414 | 139,312 | |||||
| Total liabilities and stockholders' equity | $ | 228,536 | $ | 157,903 |
Consolidated Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||
| Revenue: | |||||||||||||
| Licensing revenue | $ | $ | $ | 2,320 | $ | ||||||||
| Other revenue | 30 | 30 | |||||||||||
| Total revenues | 30 | 2,350 | |||||||||||
| Cost of revenue | 464 | ||||||||||||
| Gross Profit | 30 | 1,886 | |||||||||||
| Operating expenses: | |||||||||||||
| Research and development | $ | 16,046 | $ | 20,572 | $ | 29,396 | $ | 42,960 | |||||
| General and administrative | 6,138 | 5,846 | 12,329 | 11,892 | |||||||||
| Total operating expenses | 22,184 | 26,418 | 41,725 | 54,852 | |||||||||
| Loss from operations | (22,154) | (26,418) | (39,839) | (54,852) | |||||||||
| Other (expense) income | (135) | 697 | 535 | 1,123 | |||||||||
| Provision for income taxes | (2) | (6) | |||||||||||
| Net loss | $(22,291) | $ | (25,721) | $ | (39,310) | $ | (53,729) | ||||||
| Net loss per common share, basic & diluted | $(0.42) | $ | (0.54) | $ | (0.78) | $ | (1.13) | ||||||
| Shares used in computing net loss per share, basic and diluted | 52,824,483 | 47,403,243 | 50,206,470 | 47,373,404 |