Full Press Release Details
Ardelyx Reports Fourth Quarter 2018 Financial Results and Recent Highlights
Company is poised for two Phase 3 readouts in 2H 2019 for tenapanor in hyperphosphatemia
FREMONT, Calif., March 6, 2019 -- Ardelyx, Inc. (Nasdaq: ARDX), a 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 fourth quarter and full year ended December 31, 2018.
Over the last year, we made significant progress towards developing our lead product candidate, tenapanor, and executing on our plan to provide patients with this first-ever, non-binder treatment option for the treatment of hyperphosphatemia for patients on dialysis, said Mike Raab, president and chief executive officer of Ardelyx. We enter 2019 well-positioned with two years of cash on hand to deliver on our strategic goals to report results from two Phase 3 clinical trials during the second half of the year and to prepare for commercialization of our novel therapy.
Key Accomplishments in 2018
Full Year 2018 Financial Results
Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments will be sufficient to fund the company's operations until at least early 2021 based on its current operating plans.
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, 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, 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 the clinical development process, the uncertainties associated with the regulatory approval process; and the uncertainties in the drug commercialization 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 6, 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
Consolidated Condensed Balance Sheets
| December 31, | December 31, | ||||||
| 2018 | 2017 | ||||||
| (Unaudited) | (1) | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 78,768 | $ | 75,383 | |||
| Short-term investments | 89,321 | 58,593 | |||||
| Accounts receivable | 85 | 10,796 | |||||
| Unbilled license revenue | 5,000 | ||||||
| Property and equipment, net | 5,611 | 8,032 | |||||
| Prepaid and other assets | 4,547 | 5,099 | |||||
| Total Assets | $ | 183,332 | $ | 157,903 | |||
| Liabilities and stockholders' equity | |||||||
| Accounts payable and other current liabilities | $ | 16,728 | $ | 17,871 | |||
| Uncharged license fees | 1,000 | ||||||
| Loan payable, long term | 49,209 | ||||||
| Other long-term liabilities | 582 | 720 | |||||
| Stockholders' equity | 115,813 | 139,312 | |||||
| Total liabilities and stockholders' equity | $ | 183,332 | $ | 157,903 |
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (1) | ||||||||||
| Revenue: | |||||||||||||
| Licensing revenue | $ | $ | 42,000 | $ | 2,320 | $ | 42,000 | ||||||
| Other revenue | 85 | 287 | |||||||||||
| Total revenues | 85 | 42,000 | 2,607 | 42,000 | |||||||||
| Cost of revenue | 8,400 | 466 | 8,400 | ||||||||||
| Gross Profit | 85 | 33,600 | 2,141 | 33,600 | |||||||||
| Operating expenses: | |||||||||||||
| Research and development | $ | 22,036 | $ | 17,159 | $ | 69,373 | $ | 75,484 | |||||
| General and administrative | 5,425 | 5,479 | 23,715 | 23,231 | |||||||||
| Total operating expenses | 27,461 | 22,638 | 93,088 | 98,715 | |||||||||
| (Loss) income from operations | (27,376) | 10,962 | (90,947) | (65,115) | |||||||||
| Interest expense | (1,438) | (3,534) | |||||||||||
| Other income | 950 | 331 | 3,187 | 1,955 | |||||||||
| Benefit from (provision for) income taxes | 2 | (1,179) | (4) | (1,179) | |||||||||
| Net (loss) income | $ | (27,862) | $ | 10,114 | $ | (91,298) | $ | (64,339) | |||||
| Net (loss) income per common share, basic | $ | (0.45) | $ | 0.21 | $ | (1.62) | $ | (1.36) | |||||
| Shares used in computing net (loss) income per share, basic | 62,108,906 | 47,528,183 | 56,219,919 | 47,435,331 | |||||||||
| Net (loss) income per common share, diluted | $ | (0.45) | $ | 0.21 | $ | (1.62) | $ | (1.36) | |||||
| Shares used in computing net (loss) income per share, diluted | 62,108,906 | 48,724,123 | 56,219,919 | 47,435,331 |