Full Press Release Details
Ardelyx Reports Third Quarter 2017 Operating Results and Clinical Progress
FREMONT, Calif., Nov. 7, 2017 Ardelyx, Inc. (NASDAQ: ARDX), today provided an update on its clinical programs and reported financial results for
the third quarter ended September 30, 2017.
2017 has been a landmark year for Ardelyx, with three statistically significant Phase 3 trial
readouts for tenapanor two for IBS-C and one for hyperphosphatemia, said Mike Raab, chief executive officer of Ardelyx. For IBS-C patients, tenapanor
could offer a completely new mechanism of action with a demonstrated best-in-class response rate, as seen in our T3MPO-2 study.
For patients with hyperphosphatemia, tenapanor could be the first-ever non-binder treatment, potentially relieving the significant pill burden associated with binders. In order to maximize its therapeutic
opportunity across both indications, we plan to leverage collaborations as part of our strategy of efficiently bringing tenapanor to patients as quickly as possible. As we head into 2018, we are closer to realizing the significant potential that
minimally systemic, non-absorbed medicines could have for patients, which is the vision on which Ardelyx was founded.
Clinical Program Updates
Tenapanor for Hyperphosphatemia
Third Quarter 2017 Financial Results
Ardelyx is focused on enhancing the way patients with cardiorenal and gastrointestinal (GI) diseases are treated by using the gut as the gateway to delivering
medicines that matter. The company has established unique cardiorenal and GI business portfolios aimed at bringing new, effective medicines with distinct safety and dosing advantages to underserved patients. Ardelyx s cardiorenal portfolio
includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and the Phase 3 development of RDX7675 for the treatment of
people with hyperkalemia. The company s GI portfolio includes the Phase 3 development of tenapanor for the treatment of people with irritable bowel syndrome with constipation (IBS-C), and RDX8940, the
company s TGR5 agonist. For more information, please visit http://www.ardelyx.com/ and connect with us on Twitter @Ardelyx.
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; Ardelyx s future development plans for tenapanor and RDX7675 and the expected timing thereof; Ardelyx s ability to establish collaborations in the future; and Ardelyx s
expectations regarding the filing of an NDA with the FDA seeking marketing authorization for tenapanor for the treatment of IBS-C. 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 research and 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, 2017, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Monique Allaire, THRUST IR
Alicia Davis, THRUST IR
Condensed Consolidated Balance Sheets
| September 30, 2017 | December 31, 2016 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 59,454 | $ | 74,598 | ||||
| Short-term investments | 69,834 | 126,225 | ||||||
| Property and equipment, net | 8,622 | 8,991 | ||||||
| Prepaid and other assets | 5,195 | 3,317 | ||||||
| Total Assets | $ | 143,105 | $ | 213,131 | ||||
| Liabilities and stockholders equity | ||||||||
| Accounts payable and other current liabilities | $ | 15,727 | $ | 19,201 | ||||
| Long-term liabilities | 741 | 779 | ||||||
| Stockholders equity | 126,637 | 193,151 | ||||||
| Total liabilities and stockholders equity | $ | 143,105 | $ | 213,131 |
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,365 | $ | 24,863 | $ | 58,325 | $ | 67,951 | ||||||||
| General and administrative | 5,860 | 4,337 | 17,752 | 13,469 | ||||||||||||
| Total operating expenses | 21,225 | 29,200 | 76,077 | 81,420 | ||||||||||||
| Loss from operations | (21,225 | ) | (29,200 | ) | (76,077 | ) | (81,420 | ) | ||||||||
| Other income | 501 | 169 | 1,624 | 307 | ||||||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | (20,724 | ) | $ | (29,031 | ) | $ | (74,453 | ) | $ | (81,113 | ) | ||||
| Net loss per common share, basic & diluted | $ | (0.44 | ) | $ | (0.65 | ) | $ | (1.57 | ) | $ | (2.15 | ) | ||||
| Shares used in computing net loss per share, basic and diluted | 47,464,310 | 44,935,126 | 47,404,039 | 37,706,045 |