Full Press Release Details
Ardelyx Reports Third Quarter 2020 Financial Results and
Tenapanor NDA Accepted for Review by FDA; PDUFA Goal Date set for April 29, 2021
Maintains strong balance sheet with $185.5 million in cash, cash equivalents and short-term investments
FREMONT, Calif., November 5, 2020 -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported business highlights and financial results for the third quarter ended September 30, 2020.
"The FDA's acceptance of our New Drug Application for tenapanor is a major milestone that continues our progress toward the potential launch of this novel therapeutic for the many dialysis patients who struggle with controlling hyperphosphatemia." said Mike Raab, president and chief executive officer of Ardelyx. "Our commitment to this field was further highlighted in clinical data presented at ASN Kidney Week 2020 generated by Ardelyx and our Japanese partner KKC, supporting the clinical safety and efficacy of tenapanor and reinforcing its potential to transform the treatment landscape for patients."
Recent Business and Pipeline Updates
Third Quarter 2020 Financial Results
Ardelyx is focused on developing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiovascular diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA, with a PDUFA goal date of April 29, 2021. Ardelyx is also advancing 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 received FDA approval of IBSRELA (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.
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 statements regarding the potential for the use of tenapanor as monotherapy and as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia. Such forward-looking statements involve substantial risks and uncertainties that could cause 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 associated with the regulatory approval process and 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 to be filed with the Securities and Exchange Commission on November 5, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contacts:
Wheelhouse Life Science Advisors
Wheelhouse Life Science Advisors
Condensed Balance Sheets
| September 30, 2020 | December 31, 2019 | |||||
| (Unaudited) | (1) | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 91,009 | $ | 181,133 | ||
| Short-term investments | 94,488 | 66,379 | ||||
| Unbilled revenue | 750 | 750 | ||||
| Property and equipment, net | 2,111 | 3,436 | ||||
| Right-of-use assets | 2,402 | 3,970 | ||||
| Prepaid and other assets | 7,795 | 4,114 | ||||
| Total assets | $ | 198,555 | $ | 259,782 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable | $ | 2,490 | $ | 2,187 | ||
| Accrued compensation and benefits | 3,722 | 4,453 | ||||
| Current portion of operating lease liability | 2,770 | 2,608 | ||||
| Loan payable, current portion | - | 1,183 | ||||
| Deferred revenue | 885 | 4,541 | ||||
| Accrued expenses and other liabilities | 6,667 | 7,248 | ||||
| Operating lease liability, net of current portion | - | 2,076 | ||||
| Loan payable, net of current portion | 50,681 | 48,831 | ||||
| Stockholders' equity | 131,340 | 186,655 | ||||
| Total liabilities and stockholders' equity | $ | 198,555 | $ | 259,782 |
Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Revenues: | ||||||||||||
| Licensing revenue | $ | - | $ | 3,000 | $ | 706 | $ | 3,000 | ||||
| Collaborative development revenue | 1,356 | - | 3,656 | - | ||||||||
| Other revenue | 1,357 | 13 | 1,400 | 31 | ||||||||
| Total revenues | 2,713 | 3,013 | 5,762 | 3,031 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of revenue | - | 600 | 141 | 600 | ||||||||
| Research and development | 12,240 | 17,580 | 46,948 | 57,436 | ||||||||
| General and administrative | 7,634 | 6,922 | 21,810 | 17,410 | ||||||||
| Total operating expenses | 19,874 | 25,102 | 68,899 | 75,446 | ||||||||
| Loss from operations | (17,161) | (22,089) | (63,137) | (72,415) | ||||||||
| Interest expense | (1,202) | (1,443) | (3,785) | (4,328) | ||||||||
| Other income, net | 255 | 294 | 1,485 | 1,896 | ||||||||
| Loss before provision for income taxes | (18,108) | (23,238) | (65,437) | (74,847) | ||||||||
| Provision for income taxes | - | 301 | - | 303 | ||||||||
| Net loss | $ | (18,108) | $ | (23,539) | $ | (65,437) | $ | (75,150) | ||||
| Net loss per common share, basic and diluted | $ | (0.20) | $ | (0.37) | $ | (0.73) | $ | (1.20) | ||||
| Shares used in computing net loss per share - basic and diluted | 89,365,798 | 62,828,513 | 89,109,772 | 62,676,591 |