Full Press Release Details
Ardelyx Reports Second Quarter 2020 Financial Results and
Recent Business Highlights
Submitted a New Drug Application to the U.S. Food and Drug Administration for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease on dialysis
Maintains strong balance sheet with $204.8 million in cash, cash equivalents and short-term investments
FREMONT, Calif., August 6, 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 second quarter ended June 30, 2020.
"Over the last quarter, we continued to make critical progress towards our goal of providing our first-in-class therapy tenapanor to adult CKD patients on dialysis with elevated serum phosphorus, a condition, despite traditional therapies, that has been associated with poor survival outcomes," said Mike Raab, president and chief executive officer of Ardelyx. "This past June, we submitted a New Drug Application to the FDA for this indication, and we expect to receive notification of its acceptance for substantive review and our PDUFA date by early September. As part of our filing, we included additional, robust data reconfirming tenapanor's ability to lower and control serum phosphorous levels at a rate better than those reported with phosphate binders alone. In addition, during the quarter, we augmented our senior leadership team with the hiring of an experienced chief commercial officer and chief financial officer as we prepare for launch and evolving into a revenue-generating company."
Recent Business and Pipeline Updates
Expected 2020 Milestones
Second 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 submitted an NDA to the FDA on June 30, 2020. 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 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 as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor alone or with adjunctive use of phosphate binders to achieve normal serum phosphorus levels, Ardelyx's expectations regarding the potential receipt, and the timing thereof, of notification from the FDA of the acceptance for substantive review of its NDA for tenapanor, and Ardelyx's expectations regarding the presentation of its clinical data at medical congresses in 2020. 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 filed with the Securities and Exchange Commission on August 6, 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
| June 30, 2020 | December 31, 2019 | |||||
| (Unaudited) | (1) | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 100,494 | $ | 181,133 | ||
| Short-term investments | 104,347 | 66,379 | ||||
| Unbilled revenue | 750 | 750 | ||||
| Property and equipment, net | 2,501 | 3,436 | ||||
| Right-of-use assets | 2,945 | 3,970 | ||||
| Prepaid and other assets | 6,306 | 4,114 | ||||
| Total assets | $ | 217,343 | $ | 259,782 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable | $ | 4,212 | $ | 2,187 | ||
| Accrued compensation and benefits | 3,081 | 4,453 | ||||
| Current portion of operating lease liability | 2,826 | 2,608 | ||||
| Loan payable, current portion | 13,716 | 1,183 | ||||
| Deferred revenue | 2,241 | 4,541 | ||||
| Accrued expenses and other liabilities | 7,574 | 7,248 | ||||
| Operating lease liability, net of current portion | 608 | 2,076 | ||||
| Loan payable, net of current portion | 36,735 | 48,831 | ||||
| Stockholders' equity | 146,350 | 186,655 | ||||
| Total liabilities and stockholders' equity | $ | 217,343 | $ | 259,782 |
(1) Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||
| Revenues: | ||||||||||||
| Licensing revenue | $ | 706 | $ | - | $ | 706 | $ | - | ||||
| Collaborative development revenue | 1,125 | - | 2,300 | - | ||||||||
| Other revenue | 5 | 18 | 43 | 18 | ||||||||
| Total revenues | 1,836 | 18 | 3,049 | 18 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of revenue | 141 | - | 141 | - | ||||||||
| Research and development | 18,864 | 19,475 | 34,708 | 39,856 | ||||||||
| General and administrative | 7,038 | 5,371 | 14,176 | 10,488 | ||||||||
| Total operating expenses | 26,043 | 24,846 | 49,025 | 50,344 | ||||||||
| Loss from operations | (24,207) | (24,828) | (45,976) | (50,326) | ||||||||
| Interest expense | (1,226) | (1,451) | (2,583) | (2,885) | ||||||||
| Other income, net | 477 | 812 | 1,230 | 1,602 | ||||||||
| Loss before provision for income taxes | (24,956) | (25,467) | (47,329) | (51,609) | ||||||||
| Provision for income taxes | - | - | - | 2 | ||||||||
| Net loss | $ | (24,956) | $ | (25,467) | $ | (47,329) | $ | (51,611) | ||||
| Net loss per common share, basic and diluted | $ | (0.28) | $ | (0.41) | $ | (0.53) | $ | (0.82) | ||||
| Shares used in computing net loss per share - basic and diluted | 89,080,046 | 62,651,863 | 88,980,353 | 62,599,371 | ||||||||
| Comprehensive loss: | ||||||||||||
| Net loss | $ | (24,956) | $ | (25,467) | $ | (47,329) | $ | (51,611) | ||||
| Unrealized gains on available-for-sale securities | 361 | 4 | 297 | 54 | ||||||||
| Comprehensive loss | $ | (24,595) | $ | (25,463) | $ | (47,032) | $ | (51,557) |