FREMONT, Calif., May 7, 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 first quarter ended
March 31, 2019.
"With our two ongoing Phase 3 clinical trials for tenapanor for
the treatment of hyperphosphatemia in patients with ESRD on
dialysis, one as a single agent therapy and the other as adjunctive
therapy with phosphate binders, we are positioned for significant
catalysts this year," said Mike
Raab, president and chief executive officer of Ardelyx.
"Current treatment options for hyperphosphatemia have many
limitations, leading to poor adherence and inadequate phosphorus
control. If the results from our PHREEDOM and AMPLIFY
clinical trials are positive and tenapanor is approved, we believe
tenapanor would be an enormous step forward in the management of
hyperphosphatemia in ESRD patients on dialysis. Tenapanor provides
a completely novel and differentiated mechanism that could lower
pill burden and improve adherence thus improving efficacy of the
patient's phosphate lowering therapy."
Recent Business and Pipeline Updates
- Published positive Phase 3 results of tenapanor for the
treatment of hyperphosphatemia in the Journal of the American
Society of Nephrology.
- Appointed renowned nephrologist, Geoff
A. Block, M.D., to its board of directors.
Expected 2019 Milestones
- The PHREEDOM clinical trial, the company's second Phase 3
clinical trial of tenapanor for hyperphosphatemia in patients with
end-stage renal disease (ESRD) who are on dialysis, is currently
expected to read out in the fourth quarter of 2019.
- The AMPLIFY clinical trial, the company's additional Phase 3
clinical trial of tenapanor as adjunctive therapy with phosphate
binders for hyperphosphatemia in patients with ESRD who are on
dialysis, is currently expected to read out in the second half of
2019.
- The company's New Drug Application for U.S. marketing
authorization of tenapanor for patients with IBS-C has a target
action date under the Prescription Drug User Fee Act (PDUFA) of
September 12, 2019.
First Quarter 2019 Financial Results
- Cash Position: As of March 31,
2019, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $151.6 million compared to total capital
resources including cash, cash equivalents and short-term
investments of $168.1 million as of
December 31, 2018.
- Revenue: Licensing revenue for the quarter ended
March 31, 2019 was zero. The company
generated $2.3 million related to
license revenue for the quarter ended March
31, 2018.
- Cost of Revenue: Cost of revenue for the quarter ended
March 31, 2019 was zero. The cost of
revenue for the quarter ended March 31,
2018 was $0.5 million.
- R&D Expenses: Research and development expenses were
$20.4 million for the three months
ended March 31, 2019, an increase of
$7.0 million, or 53 percent, compared
to $13.4 million for the three months
ended March 31, 2018. The increase
was primarily related to the Company's PHREEDOM and AMPLIFY
clinical trials as well as the RDX013 program.
- G&A Expenses: General and administrative expenses
were $5.1 million for the three
months ended March 31, 2019, a
decrease of $1.1 million, or 17
percent, compared to $6.2 million for
the three months ended March 31,
2018. The decrease was primarily related to a decrease in
professional services and a reduction in stock-based compensation
costs.
- Net Loss: Net loss for the quarter ended March 31, 2019, was $26.1
million compared to a net loss of $17.0 million for the quarter ended March 31, 2018.
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 completed
Phase 3 development of tenapanor for the treatment of irritable
bowel syndrome with constipation (IBS-C) and submitted a new drug
application, or NDA, to the U.S. Food and Drug Administration, or
FDA, for the treatment of patients with IBS-C which has been
granted a target action date under the Prescription Drug User Fee
Act (PDUFA) of September 12, 2019. 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 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 product candidates in treating the diseases and
conditions for which they are being developed, the potential for
the use of tenapanor as monotherapy and in combination with
phosphate binders as adjunctive therapy for the treatment of
hyperphosphatemia, and Ardelyx's expected timing for receipt of
data from its ongoing Phase 3 clinical trials of tenapanor for the
treatment of hyperphosphatemia in ESRD patients. 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 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 Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on May 7,
2019, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Ardelyx,
Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
92,036
|
|
$
|
78,768
|
Short-term
investments
|
|
|
59,524
|
|
|
89,321
|
Accounts
receivable
|
|
|
7
|
|
|
85
|
Unbilled license
revenue
|
|
|
—
|
|
|
5,000
|
Property and
equipment, net
|
|
|
5,102
|
|
|
5,611
|
Right-of-use
assets
|
|
|
5,371
|
|
|
—
|
Prepaid and other
assets
|
|
|
4,095
|
|
|
4,547
|
Total
assets
|
|
$
|
166,135
|
|
$
|
183,332
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Accounts payable and
other current liabilities
|
|
$
|
18,724
|
|
$
|
16,728
|
Uncharged license
fees
|
|
|
—
|
|
|
1,000
|
Current portion of
operating lease liability
|
|
|
2,102
|
|
|
—
|
Operating lease
liability, net of current portion
|
|
|
4,069
|
|
|
—
|
Loan payable, long
term
|
|
|
49,399
|
|
|
49,209
|
Other long-term
liabilities
|
|
|
—
|
|
|
582
|
Stockholders'
equity
|
|
|
91,841
|
|
|
115,813
|
Total liabilities and
stockholders' equity
|
|
$
|
166,135
|
|
$
|
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 March 31,
|
|
|
2019
|
|
2018
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
Licensing
revenue
|
|
$
|
—
|
|
$
|
2,320
|
Cost of
revenue
|
|
|
—
|
|
|
464
|
Gross
profit
|
|
|
—
|
|
|
1,856
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
20,381
|
|
$
|
13,350
|
General and
administrative
|
|
|
5,117
|
|
|
6,191
|
Total operating
expenses
|
|
|
25,498
|
|
|
19,541
|
Loss from
operations
|
|
|
(25,498)
|
|
|
(17,685)
|
Interest
expense
|
|
|
(1,434)
|
|
|
—
|
Other
income
|
|
|
790
|
|
|
670
|
Provision for income
taxes
|
|
|
(2)
|
|
|
(4)
|
Net
loss
|
|
$
|
(26,144)
|
|
$
|
(17,019)
|
Net loss per
common share, basic & diluted
|
|
$
|
(0.42)
|
|
$
|
(0.36)
|
Shares used in
computing net loss per share, basic and diluted
|
|
|
62,546,295
|
|
|
47,559,366
|
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SOURCE Ardelyx