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,
2019
|
|
December 31,
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