Full Press Release Details
Ardelyx Focuses Resources on Late-Stage Programs and Reports Second Quarter 2017 Operational Results
Restructuring Aligns Resources on Execution of Late-Stage Program Milestones
T3MPO-2 Phase 3 Trial Results of Tenapanor for IBS-C on
Track for Early Fourth Quarter;
Onset-of-Action Data Planned for Fourth Quarter
Conference Call to be Held at 8:00 a.m. ET Today
FREMONT, Calif., Aug. 9, 2017 Ardelyx, Inc. (NASDAQ: ARDX), a late-stage clinical company focused on enhancing the treatment of patients
with cardiorenal and gastrointestinal (GI) diseases, today announced an update of its business operations and clinical programs, as well as reported financial results for the second quarter ended June 30, 2017.
At Ardelyx, we have advanced a unique, late-stage pipeline of programs, led by our
first-in-class drug candidate, tenapanor, in Phase 3 development for both IBS-C and hyperphosphatemia, and RDX7675, our
proprietary binder for the treatment of hyperkalemia, which is also in Phase 3 development, said Mike Raab, president and chief executive officer of Ardelyx. Based on the clinical data we ve generated to date, we are highly
confident in both the registration and commercial potential for tenapanor and RDX7675. In order to fully focus on the execution of our late-stage pipeline, we have implemented a plan designed to align our resources to deliver on these programs,
while also creating strategic optionality and reinforcing our financial strength.
Mr. Raab continued, As a result of a comprehensive
strategic review, we have chosen to reduce our workforce, an inherently difficult endeavor. I am proud of everything the Ardelyx team has accomplished over the years, and am incredibly grateful for the hard work, dedication and innovations
contributed by each person impacted by this decision. As we look ahead, we are confident that the changes we are making now, and the extraordinary team that remains at Ardelyx, will best position us to efficiently execute on our near-term milestones
and to create value in the future.
Strategic Restructuring and Updated Financial Guidance
Ardelyx completed a comprehensive strategic review of its operations, assessing several core areas, to optimally position the company to advance towards
delivering on multiple significant opportunities with its late-stage portfolio and execute on its strategic objectives. This review resulted in the prioritization of resources to focus on the upcoming milestones for the late-stage programs, a delay
in the development of a number of earlier-stage programs and a reduction in workforce of 28 percent, resulting in a remaining team of 76 employees.
Ardelyx believes that with this, and other cost-saving activities, the company is positioned to extend its operating runway to the end of 2018, excluding any
revenues generated through potential partnerships. The company expects to incur approximately $0.8 million in one-time, cash-related restructuring expenses, which will be recorded predominantly in the
third quarter of 2017. Ardelyx will continue to evaluate all pathways, both internal and external, to maintain a strong balance sheet and ensure it has the necessary resources to fund its operations.
Clinical Progress and Prioritized Pipeline Activities
Second Quarter 2017 Financial Results
Conference Call Information
The company will host a
conference call today, August 9, 2017 at 8:00 a.m. ET to discuss the company s strategic review and second quarter financial results. To participate in the conference call, please dial (855) 296-9612
(toll-free) or (920) 663-6277 (toll) and reference call ID number 47784045. A webcast of the call, and reference slides, can also be accessed by visiting the Investor page of the company s website
www.ardelyx.com, and will be available on the website for 60 days following the call.
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.
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 future development plans for tenapanor and its other product candidates and the expected timing thereof; Ardelyx s expectations regarding the timing of its initiation of, and receipt of results
from its clinical trials evaluating its product candidates and for the completion of its T3MPO program; the potential of Ardelyx s drug discovery and design platform; Ardelyx s ability to generate revenues in the future; and Ardelyx s
expectations regarding the exhaustion 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 research and the clinical development
process, including the regulatory approval process, and the uncertainties in the manufacture of clinical trial material, including process development and the scale up of manufacturing processes, 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 9,
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
Consolidated Condensed Balance Sheets
| June 30, 2017 | December 31, 2016 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 63,636 | $ | 74,598 | ||||
| Short-term investments | 85,088 | 126,225 | ||||||
| Property and equipment, net | 9,335 | 8,991 | ||||||
| Prepaid and other assets | 6,063 | 3,317 | ||||||
| Total Assets | $ | 164,122 | $ | 213,131 | ||||
| Liabilities and stockholders equity | ||||||||
| Accounts payable and accrued liabilities | $ | 18,388 | $ | 19,201 | ||||
| Other liabilities | 756 | 779 | ||||||
| Stockholders equity | 144,978 | 193,151 | ||||||
| Total liabilities and stockholders equity | $ | 164,122 | $ | 213,131 |
Consolidated Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 20,572 | $ | 23,838 | $ | 42,960 | $ | 43,091 | ||||||||
| General and administrative | 5,846 | 4,852 | 11,892 | 9,130 | ||||||||||||
| Total operating expenses | 26,418 | 28,690 | 54,852 | 52,221 | ||||||||||||
| Loss from operations | (26,418 | ) | (28,690 | ) | (54,852 | ) | (52,221 | ) | ||||||||
| Other income | 697 | 77 | 1,123 | 139 | ||||||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | (25,721 | ) | $ | (28,613 | ) | $ | (53,729 | ) | $ | (52,082 | ) | ||||
| Net loss per common share, basic & diluted | $ | (0.54 | ) | $ | (0.83 | ) | $ | (1.13 | ) | $ | (1.53 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 47,403,243 | 34,636,559 | 47,373,404 | 34,051,785 |