Full Press Release Details
Ardelyx Reports Third Quarter 2018 Financial Results and Recent Highlights
Tenapanor Second Registration Trial for Hyperphosphatemia Ongoing; On-Track for Data in 2019
FREMONT, Calif., Nov. 7, 2018 -- Ardelyx, Inc. (Nasdaq: ARDX), today reported business highlights and financial results for the third quarter ended September 30, 2018.
During our first Renal Day event, we heard strong feedback from physician, dietician and policy experts on the need for greater awareness of the health risks of hyperphosphatemia and for new treatments that are both effective and convenient for patients on dialysis. Our panelists shared enthusiasm for tenapanor, making us even more energized about its potential to become the first and only non-binder treatment for this severe and highly prevalent disorder in patients on dialysis, said Mike Raab, president and chief executive officer of Ardelyx.
Tenapanor has a completely new mechanism for treating hyperphosphatemia and is easy to take, with just two small pills daily. In our first Phase 3 trial, tenapanor demonstrated efficacy in reducing serum phosphorus and a favorable safety profile. Additionally, preclinical data presented recently at ASN show encouraging synergy between tenapanor and sevelamer. We look forward to beginning a clinical trial soon to evaluate tenapanor in combination with either sevelamer or another approved phosphate binder, and to further advancing our second Phase 3 registration trial of tenapanor as monotherapy for the treatment of hyperphosphatemia, with data anticipated in 2019. Positive data from these studies would affirm our belief that tenapanor has the potential to be used both as a monotherapy and combination agent with existing phosphate binders, added Mr. Raab.
Business and Pipeline Updates
Third Quarter 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 mid-2020 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 to the U.S. Food and Drug Administration seeking U.S. marketing approval for this indication. 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 trial of tenapanor for the treatment of hyperphosphatemia in ESRD patients, Ardelyx's expected timing of receipt of notification from the FDA of acceptance for filing for substantive review of Ardelyx's NDA for the treatment of IBS-C, and Ardelyx's expectations regarding the sufficiency 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, 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 November 7, 2018, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Monique Allaire, THRUST Strategic Communications
Consolidated Condensed Balance Sheets
| September 30, 2018 | December 31, 2017 | ||||||
| (Unaudited) | (1) | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 75,015 | $ | 75,383 | |||
| Short-term investments | 111,391 | 58,593 | |||||
| Accounts receivable | 167 | 10,796 | |||||
| Unbilled license revenue | 5,000 | ||||||
| Property and equipment, net | 5,996 | 8,032 | |||||
| Prepaid and other assets | 9,099 | 5,099 | |||||
| Total Assets | $ | 206,668 | $ | 157,903 | |||
| Liabilities and stockholders' equity | |||||||
| Accounts payable and other current liabilities | $ | 14,549 | $ | 17,871 | |||
| Uncharged license fees | 1,000 | ||||||
| Loan payable, long term | 49,020 | ||||||
| Other long-term liabilities | 651 | 720 | |||||
| Stockholders' equity | 141,448 | 139,312 | |||||
| Total liabilities and stockholders' equity | $ | 206,668 | $ | 157,903 |
Consolidated Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||
| Revenue: | |||||||||||||
| Licensing revenue | $ | $ | $ | 2,320 | $ | ||||||||
| Other revenue | 172 | 202 | |||||||||||
| Total revenues | 172 | 2,522 | |||||||||||
| Cost of revenue | 2 | 466 | |||||||||||
| Gross Profit | 170 | 2,056 | |||||||||||
| Operating expenses: | |||||||||||||
| Research and development | $ | 17,941 | $ | 15,365 | $ | 47,337 | $ | 58,325 | |||||
| General and administrative | 5,961 | 5,860 | 18,290 | 17,752 | |||||||||
| Total operating expenses | 23,902 | 21,225 | 65,627 | 76,077 | |||||||||
| Loss from operations | (23,732) | (21,225) | (63,571) | (76,077) | |||||||||
| Other (expense) income | (394) | 501 | 141 | 1,624 | |||||||||
| Provision for income taxes | (6) | ||||||||||||
| Net loss | $ | (24,126) | $ | (20,724) | $ | (63,436) | $ | (74,453) | |||||
| Net loss per common share, basic & diluted | $ | (0.39) | $ | (0.44) | $ | (1.17) | $ | (1.57) | |||||
| Shares used in computing net loss per share, basic and diluted | 62,071,397 | 47,464,310 | 54,204,907 | 47,404,039 |