FREMONT, Calif. and
WALTHAM, Mass., Aug. 13, 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 second quarter ended June 30, 2021.
Recent Business Events
- On July 29, 2021, the company
announced that the U.S. Food & Drug Administration (FDA) issued
a Complete Response Letter (CRL) for the company's New Drug
Application (NDA) for tenapanor for the control of serum phosphorus
in adult patients with chronic kidney disease (CKD) on dialysis.
The company plans to request a Type A meeting with the FDA to
discuss the CRL and potential next steps to support approval of the
company's NDA.
- On August 2, 2021, the company
began implementing a restructuring plan to better align the
company's workforce and anticipated commercial and development
spend with the company's capital resources and the needs of its
business following the receipt of the CRL. In connection with the
restructuring, the company estimates that it will incur aggregate
restructuring charges of approximately $3.4
million, which will be recorded primarily in the third
quarter 2021, related to one-time termination notice and severance
payments and other employee-related costs. The company expects that
the workforce reduction will decrease its annual cash compensation
costs by approximately $17
million.
- Separately, two presentations further highlighting promising
tenapanor data were given at the European Renal Association –
European Dialysis and Transplant Association (ERA-EDTA) Virtual
Congress 2021.
Second Quarter 2021 Financial Results
- Cash Position: As of June 30, 2021, Ardelyx had
total cash, cash equivalents and short-term investments of
$171.8 million, as compared to total
cash, cash equivalents and investments of $188.6 million as of December 31, 2020.
- Revenue: The company generated $1.3 million in revenue for the three months
ended June 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
$26.0 million for the three months
ended June 30, 2021, an increase of $7.2 million, or 38 percent, compared to
$18.9 million for the three months
ended June 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.
- G&A Expenses: General and administrative expenses
were $20.1 million for the three
months ended June 30, 2021, an increase of $13.1 million, or 186 percent, compared to
$7.0 million for the three months
ended June 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.
- Net Loss: Net loss for the quarter ended June 30,
2021, was $45.2 million, as compared
to $25.0 million for the quarter
ended June 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 with regard to its interactions and communications with
the FDA and its plans and expectations as to the possibility of a
pathway to approval of tenapanor for the control of serum
phosphorus in adult patients with chronic kidney disease on
dialysis, and Ardelyx's expectations regarding the costs associated
with its restructuring plan and the reduction in annual cash
compensation costs resulting from the workforce reduction. 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, whether the company will
be able to address the deficiencies identified by the FDA, whether
additional trials will be necessary and if so, the scope of those
trials, and whether and to what extent the restructuring costs may
be in excess of what Ardelyx expects. 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 13, 2021, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
Ardelyx, Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
|
June 30,
2021
|
|
December 31,
2020
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
|
86,745
|
|
$
|
91,032
|
Investments
|
85,064
|
|
97,566
|
Property and
equipment, net
|
2,666
|
|
1,936
|
Right-of-use
assets
|
14,519
|
|
2,274
|
Prepaid and other
assets
|
15,988
|
|
8,754
|
Total assets
|
$
|
204,982
|
|
$
|
201,562
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts
payable
|
$
|
2,587
|
|
$
|
5,626
|
Accrued compensation
and benefits
|
5,939
|
|
5,672
|
Current portion of
operating lease liability
|
3,184
|
|
2,117
|
Loan payable, current
portion
|
36,111
|
|
4,167
|
Deferred
revenue
|
4,359
|
|
4,177
|
Accrued expenses and
other liabilities
|
8,552
|
|
6,657
|
Operating lease
liability, net of current portion
|
11,548
|
|
413
|
Loan payable, net of
current portion
|
15,133
|
|
46,621
|
Stockholders'
equity
|
117,569
|
|
126,112
|
Total liabilities and
stockholders' equity
|
$
|
204,982
|
|
$
|
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
June 30,
|
|
Six Months Ended
June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Collaborative
development revenue
|
1,310
|
|
1,125
|
|
2,764
|
|
2,300
|
Product supply
revenue
|
—
|
|
5
|
|
126
|
|
43
|
Licensing
revenue
|
3
|
|
706
|
|
5,005
|
|
706
|
Total
revenues
|
1,313
|
|
1,836
|
|
7,895
|
|
3,049
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
—
|
|
141
|
|
1,000
|
|
141
|
Research and
development
|
26,021
|
|
18,864
|
|
46,477
|
|
34,708
|
General and
administrative
|
20,124
|
|
7,038
|
|
37,255
|
|
14,176
|
Total operating
expenses
|
46,145
|
|
26,043
|
|
84,732
|
|
49,025
|
Loss from
operations
|
(44,832)
|
|
(24,207)
|
|
(76,837)
|
|
(45,976)
|
Interest
expense
|
(1,202)
|
|
(1,226)
|
|
(2,302)
|
|
(2,583)
|
Other income
(expense), net
|
847
|
|
477
|
|
798
|
|
1,230
|
Loss before
provision for income taxes
|
(45,187)
|
|
(24,956)
|
|
$
|
(78,341)
|
|
$
|
(47,329)
|
Provision for
income taxes
|
$
|
2
|
|
$
|
—
|
|
$
|
3
|
|
$
|
—
|
Net
loss
|
$
|
(45,189)
|
|
$
|
(24,956)
|
|
$
|
(78,344)
|
|
$
|
(47,329)
|
Net loss per
common share, basic and diluted
|
$
|
(0.45)
|
|
$
|
(0.28)
|
|
$
|
(0.79)
|
|
$
|
(0.53)
|
Shares used in
computing net loss per share - basic and diluted
|
100,040,083
|
|
89,080,046
|
|
98,617,564
|
|
88,890,353
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Ardelyx