FREMONT, Calif., Aug. 7, 2018 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), today reported business highlights and financial
results for the second quarter ended June
30, 2018.
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"Our focus during the first half of 2018 has been on execution
as we work to bring to market first-in-class medicines for renal
diseases," said Mike Raab, president
and chief executive officer of Ardelyx. "The PHREEDOM Trial, our
second Phase 3 study for tenapanor for hyperphosphatemia, is
underway and we are on track for data in 2019. If positive,
tenapanor could be the first small molecule drug on the market for
hyperphosphatemia in dialysis patients with a new, innovative
mechanism. We have also advanced our RDX013 program for
hyperkalemia and continue to make progress toward initiating
clinical development in 2019. Before those important events, we
plan to submit our first NDA for tenapanor for IBS-C early in the
fourth quarter of this year, a landmark milestone for Ardelyx. With
a healthy balance sheet, we are well positioned to achieve both our
near and longer-term objectives."
Business and Pipeline Updates
- On Track to Submit NDA for Tenapanor for IBS-C:
Following the successful completion of the Phase 3 T3MPO program in
late 2017, Ardelyx remains 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) early in the fourth quarter of 2018. Ardelyx currently
plans to pursue one or more strategic relationships to efficiently
bring tenapanor to patients with IBS-C in the United States.
- Data Presented at Digestive Disease Week:
In June 2018, Ardelyx presented its
positive, Phase 3 T3MPO-2 trial results for tenapanor for the
treatment of IBS-C in an oral presentation. In addition, Ardelyx
presented preclinical data from the company's APECCS platform
demonstrating tenapanor'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; and
preclinical data from the RDX-011 NHE3 program showing
normalization of GI transit in models of opioid-induced
constipation, multiple sclerosis and cystic fibrosis.
- Operating Runway Extended to Mid-2020: In the second
quarter of 2018, Ardelyx raised a net $103.1
million in capital, after all fees and costs, following a
successful underwritten public offering of 14,375,000 shares of its
common stock, including full exercise of the option for
overallotment, and execution of a $50
million senior secured term loan facility with Solar Capital
Ltd. and the Life Sciences Group at Bridge Bank, a division of
Western Alliance Bank. The capital raised through these activities
extends the company's runway to mid-2020, based on its current
operating plan.
Second Quarter 2018 Financial Results
- Cash Position: As of June 30,
2018, Ardelyx had total capital resources including cash,
cash equivalents and short-term investments of $212.7 million compared to total capital
resources including cash, cash equivalents and short-term
investments of $134.0 million as of
December 31, 2017.
- R&D Expenses: Research and development expenses were
$16.1 million for the three months
ended June 30, 2018, a decrease of
$4.5 million, or 22 percent, compared
to $20.6 million for the three months
ended June 30, 2017. The decrease
consisted of a $2.4 million decrease
in the company's external program costs primarily related to the
discontinuation of the RDX7675 program and reduction of activities
related to the RDX8940 program, partially offset by an increase in
expense due to the start of the company's second tenapanor
hyperphosphatemia Phase 3 clinical trial. The $4.5 million decrease further included a
$2.1 million decrease in internal
program costs, primarily due to a decrease in personnel costs,
including stock-based compensation costs as a result of a reduction
in force during the third quarter of 2017, and a related decrease
in research and development activities.
- G&A Expenses: General and administrative expenses
were $6.1 million for the three
months ended June 30, 2018, an
increase of $0.3 million, or 5
percent, compared to $5.8 million for
the three months ended June 30, 2017.
The increase was primarily due to increases in professional
services and stock-based compensation expense, partially offset by
a reduction in personnel costs due to reduction in force during the
third quarter of 2017.
- Net Loss: Net loss for the quarter ended June 30, 2018, was $22.3
million compared to a net loss of $25.7 million for the quarter ended June 30, 2017.
Conference Call Information
The company will host a conference call today, August 7, 2018, at 4:30
p.m. ET. To participate in the conference call, please dial
(855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference
call ID number 1592643. A webcast of the call can be accessed by
visiting the Investor section of the Ardelyx website at
ir.ardelyx.com. A replay of the webcast will be available on the
Ardelyx website for 60 days following the call.
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
early in the fourth quarter of 2018. To efficiently bring its
treatments to market, Ardelyx is pursuing 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, Ardelyx's expected timing for the filing of its NDA
for tenapanor for the treatment of hyperphosphatemia, Ardelyx's
expected timing for the commencement of clinical development for
its RDX013 program, and Ardelyx's expectations regarding the
exhaustion of its current capital resources. 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 Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on August 7,
2018, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Ardelyx,
Inc.
|
Consolidated
Condensed Balance Sheets
|
(In
thousands)
|
|
|
|
June
30,
2018
|
|
December 31,
2017
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
91,751
|
|
$
75,383
|
Short-term
investments
|
|
120,980
|
|
58,593
|
Accounts
receivable
|
|
30
|
|
10,796
|
Unbilled license
revenue
|
|
5,000
|
|
—
|
Property and
equipment, net
|
|
6,689
|
|
8,032
|
Prepaid and other
assets
|
|
4,086
|
|
5,099
|
Total
Assets
|
|
$
228,536
|
|
$
157,903
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
other current liabilities
|
|
$
14,609
|
|
$
17,871
|
Uncharged license
fees
|
|
1,000
|
|
—
|
Loan payable, long
term
|
|
48,836
|
|
—
|
Other long-term
liabilities
|
|
677
|
|
720
|
Stockholders'
equity
|
|
163,414
|
|
139,312
|
Total liabilities and
stockholders' equity
|
|
$
228,536
|
|
$
157,903
|
|
|
|
|
|
(1)
|
Derived from the
audited financial statements included on Form 10-K for the year
ended December 31, 2017.
|
Ardelyx,
Inc.
|
Consolidated
Condensed Statements of Operations
|
(In thousands,
except share and per share amounts)
|
|
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
—
|
|
$
—
|
|
$
2,320
|
|
$
—
|
Other
revenue
|
30
|
|
—
|
|
30
|
|
—
|
Total revenues
|
30
|
|
—
|
|
2,350
|
|
—
|
Cost of
revenue
|
—
|
|
—
|
|
464
|
|
—
|
Gross Profit
|
30
|
|
—
|
|
1,886
|
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
16,046
|
|
$
20,572
|
|
$
29,396
|
|
$
42,960
|
General and
administrative
|
6,138
|
|
5,846
|
|
12,329
|
|
11,892
|
Total operating
expenses
|
22,184
|
|
26,418
|
|
41,725
|
|
54,852
|
Loss from
operations
|
(22,154)
|
|
(26,418)
|
|
(39,839)
|
|
(54,852)
|
Other (expense)
income
|
(135)
|
|
697
|
|
535
|
|
1,123
|
Provision for income
taxes
|
(2)
|
|
—
|
|
(6)
|
|
—
|
Net
loss
|
$
(22,291)
|
|
$
(25,721)
|
|
$
(39,310)
|
|
$
(53,729)
|
Net loss per
common share, basic & diluted
|
$
(0.42)
|
|
$
(0.54)
|
|
$
(0.78)
|
|
$
(1.13)
|
Shares used in
computing net loss per share, basic and diluted
|
52,824,483
|
|
47,403,243
|
|
50,206,470
|
|
47,373,404
|
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SOURCE Ardelyx