Full Press Release Details
Ardelyx Reports 2017 Financial Results and Appoints Industry Veteran Jan Lundberg, Ph.D. to Board of
Enrollment Underway in Second Registration Study of Tenapanor for Hyperphosphatemia
NDA for Tenapanor for IBS-C on Track for Submission in Second Half of 2018
FREMONT, Calif., March 14, 2018 Ardelyx, Inc. (NASDAQ: ARDX), today reported pipeline highlights and financial results for
the fourth quarter and full-year ended December 31, 2017. In addition, industry-leading research expert Jan M. Lundberg, Ph.D. has been appointed to the company s board of directors, effective March 23, 2018.
Jan s extensive research expertise positions him as an invaluable addition to the Ardelyx team, and we are delighted that he is joining our board.
We look forward to leveraging his substantial experience, as he has been involved in the discovery, development and approval of more than 20 products, said Mike Raab, president and chief executive officer of Ardelyx. As we look ahead,
our focus is on addressing the significant need for new treatments for patients with renal diseases by developing first-in-class, small molecule medicines, as with
tenapanor for hyperphosphatemia and our RDX013 program for hyperkalemia. We believe that the combination of our proprietary drug discovery platform, renal drug development capabilities and our plans for a specialized U.S. commercial approach
targeting nephrologists, positions Ardelyx to meaningfully change the care of many patients, while creating value for shareholders.
tenapanor represents a more than $1 billion market opportunity for both hyperphosphatemia and IBS-C, added Reg Seeto, MBBS, chief operating officer of Ardelyx. For our renal pipeline, our plan
is to deploy our internal expertise to bring tenapanor to the U.S. market on our own, while leveraging strategic collaborations to bring it to markets outside the U.S. For IBS-C, we intend to leverage
collaborations to bring tenapanor to patients globally. Our collaborations with KHK in Japan and Fosun Pharma in China are each off to a strong start, and we look forward to evaluating additional opportunities to expand the reach of our novel
Full Year 2017 Financial Results
Ardelyx is focused on enhancing the
way people with renal diseases are treated by developing first-in-class medicines. Ardelyx s renal pipeline includes the Phase 3 development of tenapanor for the
treatment of hyperphosphatemia in people with end-stage renal disease 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 and anticipates submitting a New Drug Application to the U.S. Food and Drug
Administration for this indication in the second half of 2018. To efficiently bring its treatments to market, Ardelyx is pursing strategic collaborations in the U.S. and other countries, with established agreements with KHK in Japan and Fosun Pharma
in China. For more information, please visit 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; Ardelyx s expected timing for the filing of its NDA for tenapanor for the treatment of IBS-C, Ardelyx s expected timing to receive topline data for its second Phase 3
trial of tenapanor for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis, the potential for Ardelyx to receive milestone and royalty payments from Shanghai Fosun
Pharmaceutical Industrial Development and Kyowa Hakko Kirin Co., Ltd and Ardelyx s ability to establish collaborations in the future. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2018, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Monique Allaire, THRUST IR
Alicia Davis, THRUST IR
Consolidated Condensed Balance Sheets
| December 31, 2017 | December 31, 2016 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 75,383 | $ | 74,598 | ||||
| Short-term investments | 58,593 | 126,225 | ||||||
| Accounts receivable | 10,796 | |||||||
| Property and equipment, net | 8,032 | 8,991 | ||||||
| Prepaid and other assets | 5,099 | 3,317 | ||||||
| Total Assets | $ | 157,903 | $ | 213,131 | ||||
| Liabilities and stockholders equity | ||||||||
| Accounts payable and other current liabilities | $ | 17,871 | $ | 19,201 | ||||
| Long-term liabilities | 720 | 779 | ||||||
| Stockholders equity | 139,312 | 193,151 | ||||||
| Total liabilities and stockholders equity | $ | 157,903 | $ | 213,131 |
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (1) | |||||||||||||
| Revenue: | ||||||||||||||||
| Licensing revenue | $ | 42,000 | $ | $ | 42,000 | $ | ||||||||||
| Cost of revenue | 8,400 | 8,400 | ||||||||||||||
| Gross profit | 33,600 | 33,600 | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 17,159 | 26,210 | 75,484 | 94,161 | ||||||||||||
| General and administrative | 5,479 | 5,266 | 23,231 | 18,734 | ||||||||||||
| Total operating expenses | 22,638 | 31,476 | 98,715 | 112,895 | ||||||||||||
| Income (loss) from operations | 10,962 | (31,476 | ) | (65,115 | ) | (112,895 | ) | |||||||||
| Other income, net | 331 | 200 | 1,955 | 508 | ||||||||||||
| Provision for income taxes | (1,179 | ) | (1,179 | ) | ||||||||||||
| Net income (loss) | $ | 10,114 | $ | (31,276 | ) | $ | (64,339 | ) | $ | (112,387 | ) | |||||
| Net income (loss) per common share, basic | $ | 0.21 | $ | (0.66 | ) | $ | (1.36 | ) | $ | (2.80 | ) | |||||
| Shares used in computing net income (loss) per share - basic | 47,528,183 | 47,303,494 | 47,435,331 | 40,118,522 | ||||||||||||
| Net income (loss) per common share, diluted | $ | 0.21 | $ | (0.66 | ) | $ | (1.36 | ) | $ | (2.80 | ) | |||||
| Shares used in computing net income (loss) per share - diluted | 48,724,123 | 47,303,494 | 47,435,331 | 40,118,522 |