Full Press Release Details
Ardelyx Reports Third Quarter 2015 Financial Results
Two key clinical development programs accelerated, tenapanor in IBS-C and RDX022 in hyperkalemia
Initiation of a second Phase 3 clinical trial for tenapanor in IBS-C expected December 2015
Results of a pharmacodynamic study expected in January 2016 for RDX022, a novel potassium binder for the treatment of hyperkalemia
Conference Call and Webcast Today at 8:30 a.m. ET
FREMONT, Calif., November 12, 2015 /PRNewswire/ Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on
gastrointestinal and cardio-renal diseases, today announced financial results for the third quarter ended September 30, 2015. The Company also today announced that two clinical trials were initiated in October 2015: a Phase 3 clinical trial
evaluating tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and a clinical study evaluating the pharmacodynamic activity of RDX022, a potassium binder for the treatment of hyperkalemia. Additionally, the
Company indicated that it plans to initiate a Phase 2b study to evaluate tenapanor in CKD patients with hyperphosphatemia on dialysis in December 2015. Results from this study are currently expected in the second half of 2016.
We have made a tremendous amount of progress in our key clinical programs over the last few months and are on pace to surpass our previously announced
timelines for tenapanor and RDX022, Mike Raab, President and CEO of Ardelyx remarked. We are pleased to announce that we commenced the first Phase 3 clinical study of tenapanor in IBS-C in October and we now expect to commence the second
Phase 3 clinical study in December, rather than in the first quarter of 2016. A pharmacodynamic study is also now underway to evaluate our novel potassium binder, RDX022. While we previously anticipated that we would obtain results in the first half
of 2016, due to the rapid progress of the study we can now confirm that we expect results in January 2016. We are pleased with the team s productivity and look forward to ending the year with several mid to late-stage programs advancing in the
Highlights from the Third Quarter 2015 and Recent Clinical and Corporate Developments
Third Quarter 2015 Financial Results
The net loss in the third quarter of 2015 was $18.1 million, or $0.70 per basic and diluted share, compared to a net income of zero or $0.00 per basic and
diluted share in the third quarter of 2014.
Total revenue is comprised of licensing revenue and collaborative development revenue, which were both
related to the Company s license agreement with AstraZeneca. Total revenues decreased to zero in the third quarter of 2015 from $7.6 million in the third quarter of 2014 because of the termination of the AstraZeneca agreement in June 2015.
Research and development expense in the third quarter of 2015 increased to $14.7 million from $5.7 million in the third quarter of 2014. The change was
primarily due the $7.3 million in expenses incurred for the clinical trial material from AstraZeneca as well as an increase of $1.7 million for clinical development activities associated with tenapanor and RDX022, and process development for RDX022.
General and administrative expense was $3.4 million in the third quarter of 2015 as compared to $1.8 million in the third quarter of 2014. The increase
was primarily due to an increase in personnel expense and professional service fees.
Cash and cash equivalents were $129.0 million as of
September 30, 2015 as compared to $107.3 million as of December 31, 2014. The increase in cash and cash equivalents compared to December 31, 2014 was primarily due to $74.3 million in net proceeds, after all costs, from the issuance
of common stock and warrants to purchase common stock offset by changes in working capital, cash paid for purchases of property and equipment, the $15 million up-front payment to AstraZeneca in connection with the termination agreement, and the $10
million payment to AstraZeneca for reimbursement of certain research and development expenses incurred by AstraZeneca under the collaboration agreement during 2015.
Conference Call & Webcast Information
Ardelyx management will host a live conference call and webcast today at 8:30 a.m. Eastern Time to discuss the third quarter financial results. The
live webcast and a replay can be accessed by visiting Ardelyx s website on the investor page of the Company s website at http://ir.ardelyx.com/.
Please connect to the Company s website at least 15 minutes prior to the live webcast to ensure adequate
time for any software download that may be needed to access the webcast. Alternatively, please call 1-855-296-9612 (US) or 920-663-6277 (International) to listen to the live conference call. The conference ID number for the live call is 62864853.
Please dial in approximately 10 minutes prior to the call. Following the webcast, an archived version of the call will be available until November 20, 2015.
Ardelyx is a clinical-stage
biopharmaceutical company focused on the discovery, development and commercialization of innovative, minimally-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat gastrointestinal and cardio-renal
diseases. Ardelyx has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and
designed tenapanor, which it is evaluating for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and for the control of hyperphosphatemia in CKD patients on dialysis. In addition to tenapanor, Ardelyx is developing
RDX022, a non-absorbed polymer for the treatment of hyperkalemia, or high potassium, in kidney and heart disease patients. Ardelyx is also advancing several research programs focused in gastrointestinal and cardio-renal
diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx s website at www.ardelyx.com.
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 tenapanor in treating IBS-C and hyperphosphatemia in CKD patients on dialysis, Ardelyx s future development plans for tenapanor and the timing thereof, the expected timing for the
receipt of the results for the Phase 2b hyperphosphatemia clinical trial, the potential for RDX022 in treating hyperkalemia in kidney and heart disease patients, Ardelyx s future development plans for RDX022 and the timing thereof, the expected
timing for the receipt of the results for the RDX022 pharmacodynamic clinical trial and the potential of Ardelyx s drug discovery and design platform. Such forward-looking statements involve substantial risks and uncertainties that could cause
the development of tenapanor, RDX022, 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 and the uncertainties in the manufacture of clinical trial material, including process development, scale up and tech transfer of manufacturing
processes. 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 12,
2015, the Form 10-Q expected to be filed on November 12, 2015 and its future current and periodic reports to be filed with the Securities and Exchange Commission.
CONDENSED BALANCE SHEETS
| September 30, 2015 | December 31, 2014 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 129,047 | $ | 107,286 | ||||
| Accounts receivable | 2,584 | |||||||
| Property and equipment, net | 4,391 | 2,131 | ||||||
| Prepaid and other assets | 4,628 | 1,413 | ||||||
| Total Assets | $ | 138,066 | $ | 113,414 | ||||
| Liabilities and stockholders equity | ||||||||
| Accounts payable and accrued liabilities | $ | 12,584 | $ | 5,557 | ||||
| Deferred license revenue | 47,053 | |||||||
| Other liabilities | 352 | 122 | ||||||
| Stockholders equity | 125,130 | 60,682 | ||||||
| Total liabilities and stockholders equity | $ | 138,066 | $ | 113,414 |
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended Sept. 30, | Nine Months Ended Sept. 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | $ | 4,767 | $ | 21,611 | $ | 14,509 | |||||||||
| Collaborative development revenue | 2,831 | 2,415 | 10,755 | |||||||||||||
| Total revenues | 7,598 | 24,026 | 25,284 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expense | 14,705 | 5,694 | 27,101 | 18,514 | ||||||||||||
| General and administrative expense | 3,374 | 1,823 | 9,438 | 4,401 | ||||||||||||
| Total operating expenses | 18,079 | 7,517 | 36,539 | 22,915 | ||||||||||||
| (Loss) income from operations | (18,079 | ) | 81 | (12,513 | ) | 2,369 | ||||||||||
| Other expense | (77 | ) | (7 | ) | (138 | ) | (19 | ) | ||||||||
| Change in fair value of pref. stock warrant liability | (1,593 | ) | ||||||||||||||
| Benefit from income taxes | 30 | 30 | ||||||||||||||
| Net (loss) income and comprehensive (loss) income | $ | (18,126 | ) | $ | 74 | $ | (12,621 | ) | $ | 757 | ||||||
| Basic net (loss) income per share | $ | (0.70 | ) | $ | $ | (0.58 | ) | $ | ||||||||
| Diluted net (loss) income per share | $ | (0.70 | ) | $ | $ | (0.58 | ) | $ | ||||||||
| Shares used in computing basic net (loss) income per share | 25,930,928 | 18,374,277 | 21,859,383 | 7,476,642 | ||||||||||||
| Shares used in computing diluted net (loss) income per share | 25,930,928 | 19,133,217 | 21,859,383 | 7,476,642 |
Investor and Media Contact:
McClellan on behalf of Ardelyx