Ardelyx Reports Third Quarter 2019 Financial Results and Recent Highlights
FREMONT, Calif., Nov. 6, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the third quarter ended September 30, 2019.
"The third quarter was particularly exciting with two transformational milestones occurring in rapid succession and serving as major catalysts for growth and momentum at Ardelyx," said Mike Raab, president and chief executive officer of Ardelyx. "First, we were pleased to report successful results from our Phase 3 AMPLIFY study for tenapanor in hyperphosphatemia, positioning us one step closer to submitting our New Drug Application to the FDA and potentially providing our drug broadly to patients in need. On the heels of that milestone, we announced the approval of IBSRELA. This approval marked a momentous achievement for Ardelyx as our first ever product approved and represented the culmination of more than a decade of diligent execution and commitment by our talented team. Importantly, these milestones propel us toward fulfilling our mission to bring innovative first-in-class medicines to improve treatments for patients in need."
Business and Pipeline Updates
-- In October 2019, Ardelyx hosted Analyst Day, the second of an
anticipated annual event. The event featured Myles Wolf, M.D., chief of
nephrology at Duke University, and the company's new team of sales and
marketing leaders. The event focused on the significant need to improve
hyperphosphatemia management in patients on dialysis, challenges with
today's treatment options that are limited to phosphate binders, and the
commercial strategy to bring tenapanor to market, if and when approved.
A replay of the event is available on the Events and Presentations page
under the investor relations section of Ardelyx's website at
www.ardelyx.com.
-- In September 2019, Ardelyx announced positive results from the pivotal
Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have
uncontrolled hyperphosphatemia despite phosphate binder treatment. The
AMPLIFY study met the primary and all key secondary endpoints, including
demonstrating a statistically significant (p=0.0004) reduction in serum
phosphorus levels for patients treated with tenapanor and phosphate
binders compared to phosphate binders alone. Approximately two times
more patients achieved the established serum phosphorus treatment goal
of less than 5.5mg/dL in the tenapanor arm compared to binders alone (p
-values<=0.0097) for each week of treatment.
-- In September 2019, Ardelyx received FDA approval for IBSRELA(®)
(tenapanor). The company continues discussions with potential strategic
partners to market IBSRELA in the United States.
Upcoming Milestones
The company currently expects to announce results in the fourth quarter of 2019 from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis.
Third Quarter 2019 Financial Results
-- Cash Position: As of September 30, 2019, Ardelyx had total capital
resources including cash, cash equivalents and short-term investments of
$103.5 million compared to total capital resources including cash, cash
equivalents and short-term investments of $168.1 million as of December
31, 2018.
-- R&D Expenses: Research and development expenses were $17.5 million for
the three months ended September 30, 2019, a decrease of $0.4 million,
or 2 percent, compared to $17.9 million for the three months ended
September 30, 2018. The decrease in expense was primarily related to
reduction in the company's manufacturing expense of tenapanor, a
reduction in costs associated with the continued clinical development of
tenapanor for the treatment of hyperphosphatemia in CKD patients on
dialysis and a decrease in professional services, partially offset by an
increase in expenses in the company's hyperkalemia program, RDX013, an
increase in headcount and related personnel costs and an increase in
stock-based compensation expenses.
-- G&A Expenses: General and administrative expenses were $6.9 million for
the three months ended September 30, 2019, an increase of $0.9 million,
or 16 percent, compared to $6.0 million for the three months ended
September 30, 2018. The increase was primarily related to an increase in
stock-based compensation costs and an increase in professional services,
partially offset by a decrease in personnel costs related to a one-time
severance payment during the three months ended September 30, 2018.
-- Net Loss: Net loss for the three months ended September 30, 2019 was
$23.5 million, or $0.37 per share, compared to a net loss of $24.1
million, or $0.39 per share, for the three months ended September 30,
2018.
Financial Guidance
Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments are sufficient to fund the company's operations until at least early 2021 based on its current operating plans.
About Ardelyx, Inc.
Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) 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 received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. 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 products and product candidates in treating the diseases and conditions for which they are approved and being developed, the potential for the use of tenapanor as monotherapy and in combination with phosphate binders for the treatment of hyperphosphatemia, Ardelyx's expected timing for receipt and announcement of data from its ongoing PHREEDOM Phase 3 clinical trial of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis, the potential to submit a New Drug Application to the FDA for tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and the potential for the FDA approval of tenapanor in such indication, and Ardelyx's expectation regarding the exhaustion of its current capital resources. Such forward-looking statements involve substantial risks and uncertainties that could cause the development and commercialization of Ardelyx's products and 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; the uncertainties associated with the regulatory approval process; and the 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 November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc.
Condensed Balance Sheets
(In thousands)
September 30, December 31,
2019 2018
(Unaudited) (1)
Assets
Cash and cash equivalents $
92,673 $
78,768
Short-term investments 10,870 89,321
Accounts receivable 2,699 85
Unbilled license revenue 5,000
Property and equipment, net 3,943 5,611
Right-of-use assets 4,453
Prepaid and other assets 4,772 4,547
Total assets $
119,410 $
183,332
Liabilities and stockholders' equity
Accounts payable and other current liabilities $
15,175 $
16,728
Uncharged license fees 1,000
Current portion of operating lease liability 2,504
Operating lease liability, net of current
portion 2,770
Loan payable, long term 49,803 49,209
Other long-term liabilities 582
Stockholders' equity 49,158 115,813
Total liabilities and stockholders' equity $
119,410 $
183,332
(1) Derived from the audited
consolidated financial
statements included on Form
10-K for the year ended
December 31, 2018.
Ardelyx, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2019 2018 2019 2018
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenue:
Licensing revenue $
3,000
$ $
3,000 $
2,320
Other revenue 13 172 31 202
Total revenues 3,013 172 3,031 2,522
Cost of revenue 600 2 600 466
Gross Profit 2,413 170 2,431 2,056
Operating expenses:
Research and development $
17,580 $
17,941 $
57,436 $
47,337
General and administrative 6,922 5,961 17,410 18,290
Total operating expenses 24,502 23,902 74,846 65,627
Loss from operations (22,089) (23,732) (72,415) (63,571)
Interest Expense (1,443) (1,404) (4,328) (2,096)
Other income (expense), net 294 1,010 1,896 2,237
Provision for income taxes (301) (303) (6)
Net loss $
(23,539) $
(24,126) $
(75,150) $
(63,436)
Net loss per common share, basic &
diluted $
(0.37) $
(0.39) $
(1.20) $
(1.17)
Shares used in computing net loss per
share, basic and diluted 62,828,513 62,071,397 62,676,591 54,204,907
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SOURCE Ardelyx
