Full Press Release Details
Ardelyx Reports First Quarter 2019 Financial Results and
Recent Business Highlights
Two Pivotal Phase 3 readouts in 2H 2019
FREMONT, Calif., May 7, 2019 -- Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the first quarter ended March 31, 2019.
With our two ongoing Phase 3 clinical trials for tenapanor for the treatment of hyperphosphatemia in patients with ESRD on dialysis, one as a single agent therapy and the other as adjunctive therapy with phosphate binders, we are positioned for significant catalysts this year, said Mike Raab, president and chief executive officer of Ardelyx. "Current treatment options for hyperphosphatemia have many limitations, leading to poor adherence and inadequate phosphorus control. If the results from our PHREEDOM and AMPLIFY clinical trials are positive and tenapanor is approved, we believe tenapanor would be an enormous step forward in the management of hyperphosphatemia in ESRD patients on dialysis. Tenapanor provides a completely novel and differentiated mechanism that could lower pill burden and improve adherence thus improving efficacy of the patient's phosphate lowering therapy.
Recent Business and Pipeline Updates
Expected 2019 Milestones
First Quarter 2019 Financial Results
Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) 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 (IBS-C) and submitted a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for the treatment of patients with IBS-C which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019. To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has 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, the potential for the use of tenapanor as monotherapy and in combination with phosphate binders as adjunctive therapy for the treatment of hyperphosphatemia, and Ardelyx's expected timing for receipt of data from its ongoing Phase 3 clinical trials of tenapanor for the treatment of hyperphosphatemia in ESRD patients. 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 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 May 7, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contact:
Wheelhouse Life Science Advisors
Wheelhouse Life Science Advisors
Condensed Balance Sheets
| March 31, 2019 | December 31, 2018 | |||||
| (Unaudited) | (1) | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 92,036 | $ | 78,768 | ||
| Short-term investments | 59,524 | 89,321 | ||||
| Accounts receivable | 7 | 85 | ||||
| Unbilled license revenue | 5,000 | |||||
| Property and equipment, net | 5,102 | 5,611 | ||||
| Right-of-use assets | 5,371 | |||||
| Prepaid and other assets | 4,095 | 4,547 | ||||
| Total assets | $ | 166,135 | $ | 183,332 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable and other current liabilities | $ | 18,724 | $ | 16,728 | ||
| Uncharged license fees | 1,000 | |||||
| Current portion of operating lease liability | 2,102 | |||||
| Operating lease liability, net of current portion | 4,069 | |||||
| Loan payable, long term | 49,399 | 49,209 | ||||
| Other long-term liabilities | 582 | |||||
| Stockholders' equity | 91,841 | 115,813 | ||||
| Total liabilities and stockholders' equity | $ | 166,135 | $ | 183,332 |
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||
| 2019 | 2018 | |||||
| (Unaudited) | (Unaudited) | |||||
| Revenue: | ||||||
| Licensing revenue | $ | $ | 2,320 | |||
| Cost of revenue | 464 | |||||
| Gross profit | 1,856 | |||||
| Operating expenses: | ||||||
| Research and development | $ | 20,381 | $ | 13,350 | ||
| General and administrative | 5,117 | 6,191 | ||||
| Total operating expenses | 25,498 | 19,541 | ||||
| Loss from operations | (25,498) | (17,685) | ||||
| Interest expense | (1,434) | |||||
| Other income | 790 | 670 | ||||
| Provision for income taxes | (2) | (4) | ||||
| Net loss | $ | (26,144) | $ | (17,019) | ||
| Net loss per common share, basic & diluted | $ | (0.42) | $ | (0.36) | ||
| Shares used in computing net loss per share, basic and diluted | 62,546,295 | 47,559,366 |