Full Press Release Details
Ardelyx Reports Third Quarter 2019 Financial Results and Recent Highlights
PHREEDOM clinical trial to read out this quarter
FREMONT, Calif., November 6, 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 third quarter ended September 30, 2019.
The third quarter was particularly exciting with two transformational milestones occurring in rapid succession and serving as major catalysts for growth and momentum at Ardelyx, said Mike Raab, president and chief executive officer of Ardelyx. First, we were pleased to report successful results from our Phase 3 AMPLIFY study for tenapanor in hyperphosphatemia, positioning us one step closer to submitting our New Drug Application to the FDA and potentially providing our drug broadly to patients in need. On the heels of that milestone, we announced the approval of IBSRELA. This approval marked a momentous achievement for Ardelyx as our first ever product approved and represented the culmination of more than a decade of diligent execution and commitment by our talented team. Importantly, these milestones propel us toward fulfilling our mission to bring innovative first-in-class medicines to improve treatments for patients in need.
Business and Pipeline Updates
The company currently expects to announce results in the fourth quarter of 2019 from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis.
Third Quarter 2019 Financial Results
Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments are 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 received approval of IBSRELA (tenapanor). 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 Kirin (formerly known as 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 products and product candidates in treating the diseases and conditions for which they are approved and being developed, the potential for the use of tenapanor as monotherapy and in combination with phosphate binders for the treatment of hyperphosphatemia, Ardelyx's expected timing for receipt and announcement of data from its ongoing PHREEDOM Phase 3 clinical trial of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis, the potential to submit a New Drug Application to the FDA for tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and the potential for the FDA approval of tenapanor in such indication, and Ardelyx's expectation regarding the exhaustion of its current capital resources. Such forward-looking statements involve substantial risks and uncertainties that could cause the development and commercialization of Ardelyx's products and 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; 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 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
Condensed Balance Sheets
| September 30, | December 31, | |||||
| 2019 | 2018 | |||||
| (Unaudited) | (1) | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 92,673 | $ | 78,768 | ||
| Short-term investments | 10,870 | 89,321 | ||||
| Accounts receivable | 2,699 | 85 | ||||
| Unbilled license revenue | 5,000 | |||||
| Property and equipment, net | 3,943 | 5,611 | ||||
| Right-of-use assets | 4,453 | |||||
| Prepaid and other assets | 4,772 | 4,547 | ||||
| Total assets | $ | 119,410 | $ | 183,332 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable and other current liabilities | $ | 15,175 | $ | 16,728 | ||
| Uncharged license fees | 1,000 | |||||
| Current portion of operating lease liability | 2,504 | |||||
| Operating lease liability, net of current portion | 2,770 | |||||
| Loan payable, long term | 49,803 | 49,209 | ||||
| Other long-term liabilities | 582 | |||||
| Stockholders' equity | 49,158 | 115,813 | ||||
| Total liabilities and stockholders' equity | $ | 119,410 | $ | 183,332 |
(1) Derived from the audited consolidated financial statements included on Form 10-K for the year ended December 31, 2018.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||
| Revenue: | ||||||||||||
| Licensing revenue | $ | 3,000 | $ | $ | 3,000 | $ | 2,320 | |||||
| Other revenue | 13 | 172 | 31 | 202 | ||||||||
| Total revenues | 3,013 | 172 | 3,031 | 2,522 | ||||||||
| Cost of revenue | 600 | 2 | 600 | 466 | ||||||||
| Gross Profit | 2,413 | 170 | 2,431 | 2,056 | ||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 17,580 | $ | 17,941 | $ | 57,436 | $ | 47,337 | ||||
| General and administrative | 6,922 | 5,961 | 17,410 | 18,290 | ||||||||
| Total operating expenses | 24,502 | 23,902 | 74,846 | 65,627 | ||||||||
| Loss from operations | (22,089) | (23,732) | (72,415) | (63,571) | ||||||||
| Interest Expense | (1,443) | (1,404) | (4,328) | (2,096) | ||||||||
| Other income (expense), net | 294 | 1,010 | 1,896 | 2,237 | ||||||||
| Provision for income taxes | (301) | (303) | (6) | |||||||||
| Net loss | $ | (23,539) | $ | (24,126) | $ | (75,150) | $ | (63,436) | ||||
| Net loss per common share, basic & diluted | $ | (0.37) | $ | (0.39) | $ | (1.20) | $ | (1.17) | ||||
| Shares used in computing net loss per share, basic and diluted | 62,828,513 | 62,071,397 | 62, 676,591 | 54,204,907 |