FREMONT, Calif. and
WALTHAM, Mass., Nov. 12, 2021 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a biopharmaceutical company focused on the
discovery, development, and commercialization of innovative
first-in-class medicines to improve treatment for people with
kidney and cardiorenal diseases, today reported business events and
financial results for the third quarter ended September 30, 2021.
Recent Business Events
- The company presented four posters at the American Society of
Nephrology Kidney Week 2021 (ASN Kidney Week), which took place
virtually on November 4 –
November 7, 2021, highlighting
additional positive clinical observations with tenapanor, a
first-in-class phosphate absorption inhibitor which has completed
three successful Phase 3 clinical trials for the control of serum
phosphorus in adult patients with chronic kidney disease (CKD) on
dialysis. The company also shared important data focusing on the
patient experience with tenapanor from the Phase 4 OPTIMIZE trial,
which is designed to optimize the treatment of hyperphosphatemia in
patients with CKD on dialysis.
- On November 4, 2021, the company
announced that it expects to submit a Formal Dispute Resolution
Request (FDRR) by the end of the fourth quarter 2021 to appeal the
issuance of a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) for the company's New Drug Application
(NDA) for tenapanor for the control of serum phosphorus in adult
patients with CKD on dialysis.
- On October 13, 2021, the company
announced the results of an End of Review Type A meeting with FDA's
Division of Cardiology and Nephrology, noting that the meeting did
not provide clarity regarding a reasonable path forward for the
resubmission of the company's NDA for tenapanor for the control of
serum phosphorus in adult patients with CKD on dialysis.
- On October 12, 2021, the company
announced that it began implementing a restructuring plan to reduce
operating costs and better align the company's workforce with the
needs of its business following the receipt of the CRL from the FDA
on July 28, 2021, and the outcome of
the End of Review Type A meeting. The restructuring plan is
expected to be completed in December
2021.
- On September 3, 2021, the company
announced the publication of the company's long term 52-week Phase
3 PHREEDOM trial in the American Society of Nephrology Journal,
Kidney 360. The publication highlights a clinically meaningful
reduction in mean serum phosphorus from 7.7 mg/dL to 5.1 mg/dL at
the end of the 26-week treatment period in the efficacy analysis
set.
Third Quarter 2021 Financial Results
- Cash Position: As of September
30, 2021, Ardelyx had total cash, cash equivalents and
short-term investments of $141.7
million, as compared to total cash, cash equivalents and
investments of $188.6 million as of
December 31, 2020.
- Revenue: The company generated $1.2 million in revenue for the three months
ended September 30, 2021, which
primarily represents collaborative development revenue from the
2019 Research Collaboration and Option Agreement between the
company and Kyowa Kirin Co., Ltd.
- R&D Expenses: Research and development expenses were
$23.7 million for the three months
ended September 30, 2021, an increase
of $11.5 million, or 94 percent,
compared to $12.2 million for the
three months ended September 30,
2020. The increase was due primarily to clinical study costs
from the advancement of the company's OPTIMIZE study which were
partially offset by lower costs for the PHREEDOM clinical study, as
well as higher employee-related expenses for the research and
development workforce. Research and development employee-related
expenses included $1.2 million in
severance payments and other employee-related costs associated with
a restructuring implemented in August
2021.
- G&A Expenses: General and administrative expenses
were $19.7 million for the three
months ended September 30, 2021, an
increase of $12.1 million, or 158
percent, compared to $7.6 million for
the three months ended September 30,
2020. The increase in general and administrative expenses
was primarily due to an increase in costs associated with building
and staffing the company's commercial infrastructure as it prepared
for the potential regulatory approval and U.S. launch of tenapanor
for the control of serum phosphorus in adult patients with CKD on
dialysis. General and administrative employee-related expenses
included $2.4 million in severance
payments and other employee-related costs associated with a
restructuring implemented in August
2021.
- Net Loss: Net loss for the quarter ended September 30, 2021, was $43.6 million, compared to $18.1 million for the quarter ended September 30, 2020.
About Ardelyx, Inc.
Ardelyx is focused on discovering, developing and
commercializing innovative first-in-class medicines to enhance the
lives of patients with kidney and cardiorenal diseases. Ardelyx is
developing tenapanor, a novel product candidate to control serum
phosphorus in adult patients with CKD on dialysis, which has
completed three successful Phase 3 trials. Ardelyx is also
advancing RDX013, a potassium secretagogue, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and has an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. In addition, Ardelyx received FDA
approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established
agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and
commercialization of tenapanor in their respective territories.
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 Ardelyx's
expectation to submit a Formal Dispute Resolution Request to appeal
the FDA's issuance of a CRL for its NDA for tenapanor for the
control of serum phosphorus in CKD patients on dialysis, and the
expected timing thereof, and Ardelyx's expectations regarding the
timing of the completion of the restructuring that it began
implementing in October 2021. Such
forward-looking statements involve substantial risks and
uncertainties that could cause 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, uncertainties associated
with the NDA process, and the Formal Dispute Resolution process, as
well as uncertainties associated with restructuring efforts. Such
forward-looking statements involve substantial risks and
uncertainties that could cause Ardelyx's future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. 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 12,
2021, 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,
2021
|
|
December 31,
2020
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
|
75,288
|
|
$
|
91,032
|
Investments
|
66,363
|
|
97,566
|
Accounts
receivable
|
287
|
|
—
|
Property and
equipment, net
|
2,651
|
|
1,936
|
Right-of-use
assets
|
13,580
|
|
2,274
|
Prepaid and other
assets
|
12,679
|
|
8,754
|
Total
assets
|
$
|
170,848
|
|
$
|
201,562
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts
payable
|
$
|
4,263
|
|
$
|
5,626
|
Accrued compensation
and benefits
|
4,770
|
|
5,672
|
Current portion of
operating lease liability
|
3,391
|
|
2,117
|
Loan payable, current
portion
|
44,444
|
|
4,167
|
Deferred
revenue
|
3,474
|
|
4,177
|
Accrued expenses and
other liabilities
|
11,373
|
|
6,657
|
Operating lease
liability, net of current portion
|
10,669
|
|
413
|
Loan payable, net of
current portion
|
7,032
|
|
46,621
|
Stockholders'
equity
|
81,432
|
|
126,112
|
Total liabilities and
stockholders' equity
|
$
|
170,848
|
|
$
|
201,562
|
|
|
(1)
|
Derived from the
audited financial statements included in the Company's Annual
Report on Form 10-K for the year ended December 31,
2020.
|
Ardelyx, Inc. Condensed Statements
of Operations (Unaudited) (In thousands, except
share and per share amounts)
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Collaborative
development revenue
|
$
|
886
|
|
$
|
1,356
|
|
$
|
3,650
|
|
$
|
3,656
|
Product supply
revenue
|
285
|
|
1,357
|
|
411
|
|
1,400
|
Licensing
revenue
|
2
|
|
—
|
|
5,007
|
|
706
|
Total
revenues
|
1,173
|
|
2,713
|
|
9,068
|
|
5,762
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
—
|
|
—
|
|
1,000
|
|
141
|
Research and
development
|
23,695
|
|
12,240
|
|
70,172
|
|
46,948
|
General and
administrative
|
19,714
|
|
7,634
|
|
56,969
|
|
21,810
|
Total operating
expenses
|
43,409
|
|
19,874
|
|
128,141
|
|
68,899
|
Loss from
operations
|
(42,236)
|
|
(17,161)
|
|
(119,073)
|
|
(63,137)
|
Interest
expense
|
(1,216)
|
|
(1,202)
|
|
(3,518)
|
|
(3,785)
|
Other (expense)
income, net
|
(134)
|
|
255
|
|
664
|
|
1,485
|
Loss before
provision for income taxes
|
(43,586)
|
|
(18,108)
|
|
$
|
(121,927)
|
|
$
|
(65,437)
|
Provision for
income taxes
|
1
|
|
—
|
|
4
|
|
—
|
Net
loss
|
$
|
(43,587)
|
|
$
|
(18,108)
|
|
$
|
(121,931)
|
|
$
|
(65,437)
|
Net loss per
common share, basic and diluted
|
$
|
(0.42)
|
|
$
|
(0.20)
|
|
$
|
(1.21)
|
|
$
|
(0.73)
|
Shares used in
computing net loss per share - basic and diluted
|
104,144,606
|
|
89,365,798
|
|
100,480,156
|
|
89,109,772
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Ardelyx