Ardelyx Reports Second Quarter 2020 Financial Results and Recent Business Highlights
FREMONT, Calif., Aug. 6, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported business highlights and financial results for the second quarter ended June 30, 2020.
"Over the last quarter, we continued to make critical progress towards our goal of providing our first-in-class therapy tenapanor to adult CKD patients on dialysis with elevated serum phosphorus, a condition, despite traditional therapies, that has been associated with poor survival outcomes," said Mike Raab, president and chief executive officer of Ardelyx. "This past June, we submitted a New Drug Application to the FDA for this indication, and we expect to receive notification of its acceptance for substantive review and our PDUFA date by early September. As part of our filing, we included additional, robust data reconfirming tenapanor's ability to lower and control serum phosphorous levels at a rate better than those reported with phosphate binders alone. In addition, during the quarter, we augmented our senior leadership team with the hiring of an experienced chief commercial officer and chief financial officer as we prepare for launch and evolving into a revenue-generating company."
Recent Business and Pipeline Updates
-- Submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for the review of tenapanor as a first-in-class
therapy to control serum phosphorus in adult patients with chronic
kidney disease (CKD) on dialysis. The filing is supported by three
successful Phase 3 studies demonstrating tenapanor's ability to reduce
phosphate levels, with two trials evaluating tenapanor as a monotherapy
and the third evaluating tenapanor as part of a dual mechanism approach
with phosphate binders.
-- Released additional positive data from the ongoing NORMALIZE Phase 4
study, which showed that foundational use of tenapanor as monotherapy or
with sevelamer enabled up to 47.4% of CKD patients on dialysis to
achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement
over current standard of care.
-- Announced that Ardelyx's collaboration partner in Japan, Kyowa Kirin
Co., Ltd. (KKC), presented data at the European Renal
Association-European Dialysis and Transplant Association annual meeting
(ERA-EDTA 2020) from a Phase 2 study designed to evaluate if, with
tenapanor, patients with hyperphosphatemia undergoing hemodialysis could
achieve at least a 30% decrease in mean pill burden while maintaining
their serum phosphorus level. The results demonstrated that tenapanor
enabled a significant reduction in overall pill burden (mean reduction
in phosphate binder pill usage by 80%), while maintaining serum
phosphorus control.
-- Strengthened leadership team with the appointment of two senior
executives:
-- Justin Renz, a veteran biopharma executive with over 20 years of
experience, as chief financial officer; and
-- Susan Rodriguez, a highly experienced global biopharma marketing and
sales executive with a proven track record of building commercial
organizations and leading successful new product launches, as chief
commercial officer
Expected 2020 Milestones
-- Receive notification from the FDA regarding the acceptance for
substantive review of the NDA submission and PDUFA date in September
2020
-- Initiate the OPTIMIZE clinical trial, a study designed to inform
physicians on the integration of tenapanor as a foundational therapy
into clinical practice, this year
-- Present AMPLIFY and PHREEDOM Phase 3 clinical trial results at upcoming
medical congresses
-- Report completed NORMALIZE Phase 4 clinical trial results at an upcoming
medical conference
Second Quarter 2020 Financial Results
-- Cash Position: As of June 30, 2020, Ardelyx had total cash, cash
equivalents and short-term investments of $204.8 million, as compared to
total cash, cash equivalents and short-term investments of $247.5
million as of December 31, 2019.
-- Revenue: The company generated $1.8 million in revenue, which primarily
represents collaborative development revenue, for the three months ended
June 30, 2020.
-- R&D Expenses: Research and development expenses were $18.9 million for
the three months ended June 30, 2020, a decrease of $0.6 million, or
approximately 3 percent, compared to $19.5 million for the three months
ended June 30, 2019. The decrease was due primarily to a decrease in
external R&D expenses, with a $1.1 million decrease in tenapanor-related
expenses, as well as a $0.6 million decrease in RDX013 program-related
expenses, partially offset by $0.7 million of higher expenses
attributable to the research programs being conducted under the Research
Collaboration and Option Agreement entered into between Ardelyx and KKC
in 2019 and general R&D expenses. Of the overall tenapanor-related
decrease, approximately $7.9 million was related to lower clinical study
costs due to the winding down of expenses associated with the Phase 3
clinical program for tenapanor for the control of hyperphosphatemia,
offset by an out-of-period adjustment that reduced clinical trial
expenses by $4.1 million; and an approximately $2.1 million decrease in
validation-related manufacturing expenses; offset by increase of $4.6
million related to regulatory expenses that included $2.9 million paid
to the FDA for the filing of the NDA for tenapanor for control of serum
phosphorus.
-- G&A Expenses: General and administrative expenses were $7.0 million for
the three months ended June 30, 2020, an increase of $1.6 million, or
approximately 31 percent, compared to $5.4 million for the three months
ended June 30, 2019. The increase was primarily due to an increase in
headcount and related personnel costs, including stock-based
compensation costs, and an increase in professional services.
-- Net Loss: Net loss for the quarter ended June 30, 2020 was $25.0
million, as compared to $25.5 million for the quarter ended June 30,
2019.
About Ardelyx, Inc.
Ardelyx is focused on developing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiovascular diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA on June 30, 2020. Ardelyx is also advancing 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 received FDA approval of IBSRELA(®) (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.
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 statements regarding 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 as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor alone or with adjunctive use of phosphate binders to achieve normal serum phosphorus levels, Ardelyx's expectations regarding the potential receipt, and the timing thereof, of notification from the FDA of the acceptance for substantive review of its NDA for tenapanor, and Ardelyx's expectations regarding the presentation of its clinical data at medical congresses in 2020. Such forward-looking statements involve substantial risks and uncertainties that could cause 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 associated with the regulatory approval process 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 6, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc.
Condensed Balance Sheets
(In thousands)
June 30, December 31,
2020 2019
(Unaudited) (1)
Assets
Cash and cash equivalents $
100,494 $
181,133
Short-term investments 104,347 66,379
Unbilled revenue 750 750
Property and equipment, net 2,501 3,436
Right-of-use assets 2,945 3,970
Prepaid and other assets 6,306 4,114
Total assets $
217,343 $
259,782
Liabilities and stockholders' equity
Accounts payable $
4,212 $
2,187
Accrued compensation and benefits 3,081 4,453
Current portion of operating lease liability 2,826 2,608
Loan payable, current portion 13,716 1,183
Deferred revenue 2,241 4,541
Accrued expenses and other liabilities 7,574 7,248
Operating lease liability, net of current portion 608 2,076
Loan payable, net of current portion 36,735 48,831
Stockholders' equity 146,350 186,655
Total liabilities and stockholders' equity $
217,343 $
259,782
________________
(1) Derived from the audited financial
statements included in the
Company's Annual Report on Form
10-K for the year ended December
31, 2019.
Ardelyx, Inc.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2020 2019 2020 2019
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues:
Licensing revenue $
706
$ $
706
$
Collaborative development revenue 1,125 2,300
Other revenue 5 18 43 18
Total revenues 1,836 18 3,049 18
Operating expenses:
Cost of revenue 141 141
Research and development 18,864 19,475 34,708 39,856
General and administrative 7,038 5,371 14,176 10,488
Total operating expenses 26,043 24,846 49,025 50,344
Loss from operations (24,207) (24,828) (45,976) (50,326)
Interest expense (1,226) (1,451) (2,583) (2,885)
Other income, net 477 812 1,230 1,602
Loss before provision for income taxes (24,956) (25,467) (47,329) (51,609)
Provision for income taxes 2
Net loss $
(24,956) $
(25,467) $
(47,329) $
(51,611)
Net loss per common share, basic and diluted $
(0.28) $
(0.41) $
(0.53) $
(0.82)
Shares used in computing net loss per share - basic 89,080,046 62,651,863 88,980,353 62,599,371
and diluted
Comprehensive loss:
Net loss $
(24,956) $
(25,467) $
(47,329) $
(51,611)
Unrealized gains on available-for-sale securities 361 4 297 54
Comprehensive loss $
(24,595) $
(25,463) $
(47,032) $
(51,557)
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SOURCE Ardelyx
