FREMONT, Calif., May 8, 2018 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), today reported business highlights and financial
results for the first quarter ended March
31, 2018.
"The first quarter of 2018 has been about execution for
Ardelyx," said Mike Raab, president
and chief executive officer of Ardelyx. "We are focused on
enrolling our second Phase 3 study for tenapanor for
hyperphosphatemia and investigating the potential of our RDX013
program for the treatment of hyperkalemia. In addition, our team is
preparing the NDA submission for tenapanor for IBS-C, which, when
submitted, will be a landmark milestone for our company. We now
have three strategic collaborations in place that will enable us to
bring tenapanor to patients in geographies outside of the U.S.,
positioning us to be able to meaningfully impact the care of many
patients."
Recent Business and Pipeline Updates
- On Track to Submit NDA for Tenapanor for IBS-C in 2H
2018: Following the successful completion of the T3MPO program
in late 2017, Ardelyx is on-track to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for tenapanor
for irritable bowel syndrome with constipation (IBS-C) in the
second half of 2018. The Phase 3 T3MPO program was designed to
support the registration of tenapanor for the treatment of
IBS-C.
- Patient Enrollment Underway in Second Phase 3 Clinical Trial
of Tenapanor for Hyperphosphatemia: In February 2018, Ardelyx began treating patients in
the Phreedom Trial, the company's second Phase 3 clinical trial of
tenapanor for the treatment of hyperphosphatemia in patients with
end-stage renal disease who are on dialysis. This clinical trial
includes a 26-week open-label treatment period, with a 12-week
placebo-controlled randomized withdrawal period followed by an
additional 14-week open-label safety extension period for a total
of up to 52 weeks. An active control group, for safety analysis
only and consistent with other Phase 3 registration studies for
hyperphosphatemia, will receive sevelamer, open-label, for the
entire 52-week study period. Ardelyx currently expects to report
topline data from this clinical trial in 2019.
- Knight Therapeutics Agreement Brings Tenapanor for IBS-C and
Hyperphosphatemia to Canada: A
license agreement with Knight Therapeutics, Inc. (Knight), signed
in March 2018, provides Knight with
exclusive rights to commercialize tenapanor in Canada for the treatment of IBS-C and
hyperphosphatemia. Under the terms of the agreement, Ardelyx is
eligible to receive up to CAD 25
million in total payments, including an upfront payment and
development and sales milestones, as well as double-digit tiered
royalties on net sales. Knight will have the exclusive rights to
market and sell tenapanor in Canada.
Upcoming Digestive Disease Week Presentations
Ardelyx has been selected to give an oral presentation of its
Phase 3 T3MPO-2 trial results for tenapanor for the treatment of
IBS-C in the clinical sciences late-breaking plenary session. The
company is also presenting three posters. Ardelyx will present
preclinical data from the company's APECCS platform demonstrating
tenpanor's pain mechanism, preclinical data from its RDX-023 FXR
agonist program showing reduction in steatosis, inflammation and
fibrosis in three mouse models of NASH, as well as preclinical data
from the RDX-011 NHE3 program showing normalization of GI transit
in models of opioid-induced constipation, multiple sclerosis and
cystic fibrosis. Digestive Disease Week is being held June 2-5, 2018 in Washington D.C.
First Quarter 2018 Financial Results
- Cash Position: As of March 31,
2018, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $127.4 million compared to total capital
resources including cash, cash equivalents and short-term
investments of $134.0 million as of
December 31, 2017.
- Revenue: Licensing revenue for the quarter ended
March 31, 2018 was $2.3 million, related to the recognition of
revenue from licensing activities. The company generated no license
revenue for the quarter ended March 31,
2017.
- Cost of Revenue: Cost of revenue for the quarter ended
March 31, 2018 was $0.5 million representing license payments due to
AstraZeneca in accordance with the company's termination agreement
entered into with AstraZeneca in June
2015. The company generated no revenue for the quarter ended
March 31, 2017 and therefore had no
cost of revenue.
- R&D Expenses: Research and development expenses were
$13.4 million for the three months
ended March 31, 2018, a decrease of
$9.0 million, or 40 percent, compared
to $22.4 million for the three months
ended March 31, 2017. The decrease
consisted of a $7.0 million decrease
in external program costs primarily related to a decrease in
expenses incurred for clinical development activities related to
the completion of some of the company's Phase 3 clinical trials for
tenapanor, offset partially by an increase from the start of the
company's hyperphosphatemia Phase 3 study, discontinuation of the
RDX7675 program and reduction of activities associated with the
company's RDX8940 program. The $9.0
million decrease further included a $2.0 million decrease in internal program costs,
primarily due to a decrease in salaries and related costs,
including stock-based compensation costs, resulting from a
reduction in work force during the third quarter of 2017.
- G&A Expenses: General and administrative expenses
were $6.2 million for the three
months ended March 31, 2018, an
increase of $0.2 million, or 2
percent, compared to $6.0 million for
the three months ended March 31,
2017, remaining relatively flat. The increase was primarily
due to increases in stock-based compensation expense, partially
offset by a reduction in salaries and related costs due to
reduction in work force during the third quarter of 2017.
- Net Loss: Net loss for the quarter ended March 31, 2018, was $17.0
million compared to a net loss of $28.0 million for the quarter ended March 31, 2017.
About Ardelyx, Inc.
Ardelyx is focused on enhancing the way people with renal
diseases are treated by developing first-in-class
medicines. Ardelyx's renal pipeline includes the Phase 3
development of tenapanor for the treatment of hyperphosphatemia in
people with end-stage renal disease 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 and anticipates submitting a New Drug Application to
the U.S. Food and Drug Administration for this indication
in the second half of 2018. To efficiently bring its treatments to
market, Ardelyx is pursing strategic collaborations in
the U.S. and outside the U.S., with 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; Ardelyx's expected
timing for the filing of its NDA for tenapanor for the treatment of
IBS-C, Ardelyx's expected timing to report topline data for its
second Phase 3 clinical trial of tenapanor for the treatment of
hyperphosphatemia in patients with end-stage renal disease who are
on dialysis, the potential for Ardelyx to receive milestone and
royalty payments from Knight Therapeutics and Ardelyx's ability to
establish collaborations in the future. 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. 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 Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 14,
2018, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Ardelyx,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(In
thousands)
|
|
|
|
March
31,
2018
|
|
December 31,
2017
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
67,745
|
|
$
75,383
|
Short-term
investments
|
|
59,704
|
|
58,593
|
Accounts
receivable
|
|
—
|
|
10,796
|
Unbilled license
revenue
|
|
5,000
|
|
—
|
Property and
equipment, net
|
|
7,358
|
|
8,032
|
Prepaid and other
assets
|
|
3,030
|
|
5,099
|
Total
assets
|
|
$
142,837
|
|
$
157,903
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
other current liabilities
|
|
$
12,162
|
|
$
17,871
|
Uncharged license
fees
|
|
1,000
|
|
—
|
Long-term
liabilities
|
|
699
|
|
720
|
Stockholders'
equity
|
|
128,976
|
|
139,312
|
Total liabilities and
stockholders' equity
|
|
$
142,837
|
|
$
157,903
|
|
(1)
Derived from the audited consolidated financial statements included
on Form 10-K for the year ended December 31, 2017.
|
Ardelyx,
Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands,
except share and per share amounts)
|
|
|
Three Months Ended
March 31,
|
|
2018
|
|
2017
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
Licensing
revenue
|
$
2,320
|
|
$
—
|
|
Cost of revenue
|
464
|
|
—
|
|
Gross
profit
|
1,856
|
|
—
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
$
13,350
|
|
$
22,387
|
|
General and
administrative
|
6,191
|
|
6,047
|
|
Total operating
expenses
|
19,541
|
|
28,434
|
|
Loss from
operations
|
(17,685)
|
|
(28,434)
|
|
Other
income
|
670
|
|
426
|
|
Provision for income
taxes
|
(4)
|
|
—
|
|
Net
loss
|
$
(17,019)
|
|
$
(28,008)
|
|
Net loss per
common share, basic & diluted
|
$
(0.36)
|
|
$
(0.59)
|
|
Shares used in
computing net loss per share, basic and diluted
|
47,559,366
|
|
47,343,234
|
|
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SOURCE Ardelyx