FREMONT, Calif. and WALTHAM,
Mass., May 6, 2021
/PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical
company focused on developing innovative first-in-class medicines
to improve treatment for people with kidney and cardiorenal
diseases, today reported business highlights and financial results
for the first quarter ended March 31,
2021.
"We continue to prepare for the potential approval and launch of
tenapanor following the recent extension of our PDUFA date to
July 29, 2021," said Mike Raab, president and chief executive officer
of Ardelyx. "We remain confident in the comprehensive data included
in our New Drug Application and believe tenapanor represents an
attractive alternative to currently available therapies to control
serum phosphorus in CKD patients on dialysis. To that end, we are
committed to working with the FDA through the completion of its
review of our NDA and look forward to the possibility of making a
significant impact in the lives of patients."
Recent Business and Pipeline Updates
- Prescription Drug User Fee Act (PDUFA) date for tenapanor for
the control of serum phosphorus in adult patients with chronic
kidney disease (CKD) on dialysis was extended by three months to
July 29, 2021.
- Received a $5 million milestone
payment in April 2021 from the
company's collaboration partner, Kyowa Kirin Co., Ltd. (KKC)
following KKC's initiation of four Phase 3 clinical studies of
tenapanor for hyperphosphatemia patients on dialysis in
Japan.
- Appointed industry veteran, Muna
Bhanji, R.Ph., to the company's board of directors.
- Presented two posters: 1) the mechanistic understanding of
phosphate absorption and 2) continuing education needs of
clinicians managing hyperphosphatemia, at the National Kidney
Foundation 2021 Spring Clinical Meeting.
- Presented poster titled: A Long-Term, Open Label Study to
Evaluate the Ability of Tenapanor Alone or in Combination with
Sevelamer to Achieve Normal Serum Phosphorus in Patients with CKD
on Dialysis (NORMALIZE) at the ISN World Congress of Nephrology
2021.
First Quarter 2021 Financial Results
- Cash Position: As of March 31, 2021, Ardelyx had
total cash, cash equivalents and short-term investments of
$178.2 million, as compared to total
cash, cash equivalents and short-term investments of $188.6 million as of December 31, 2021.
- Revenue: The company generated $6.6 million in revenue, which primarily
represents a $5.0 million milestone
from KKC following its initiation of four Phase 3 clinical studies
of tenapanor for hyperphosphatemia patients on dialysis in
Japan.
- R&D Expenses: Research and development expenses were
$20.5 million for the
three months ended March 31, 2021, an increase of
$4.6 million, or 29 percent,
compared to $15.8 million for the
three months ended March 31, 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 $17.1 million for the
three months ended March 31, 2021, an increase of
$10.0 million, or 140 percent,
compared to $7.1 million for the
three months ended March 31, 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 prepares for the
anticipated U.S. launch of tenapanor for the control of serum
phosphorus in CKD patients on dialysis.
- Net Loss: Net loss for the quarter ended March 31,
2021 was $33.2 million, as compared
to $22.4 million for the quarter
ended March 31, 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
advancing tenapanor, a novel product candidate to control serum
phosphorus in adult patients with CKD on dialysis, for which the
company's NDA is currently under review by the FDA. 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, 2020. 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 statements
regarding the potential for tenapanor to be approved for marketing
by the FDA for the control of serum phosphorus in chronic kidney
disease patients on dialysis. 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, the uncertainties associated with 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 May 6,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Ardelyx, Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
March 31,
2021
|
|
December 31,
2020
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
|
84,070
|
|
$
|
91,032
|
Investments
|
94,142
|
|
97,566
|
Accounts
receivable
|
5,783
|
|
—
|
Property and
equipment, net
|
2,292
|
|
1,936
|
Right-of-use
assets
|
1,667
|
|
2,274
|
Prepaid and other
assets
|
22,339
|
|
8,754
|
Total
assets
|
$
|
210,293
|
|
$
|
201,562
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts
payable
|
$
|
5,378
|
|
$
|
5,626
|
Accrued compensation
and benefits
|
4,348
|
|
5,672
|
Current portion of
operating lease liability
|
1,412
|
|
2,117
|
Loan payable, current
portion
|
16,667
|
|
4,167
|
Deferred
revenue
|
5,670
|
|
4,177
|
Accrued expenses and
other liabilities
|
11,262
|
|
6,657
|
Operating lease
liability, net of current portion
|
397
|
|
413
|
Loan payable, net of
current portion
|
34,348
|
|
46,621
|
Stockholders'
equity
|
130,811
|
|
126,112
|
Total liabilities and
stockholders' equity
|
$
|
210,293
|
|
$
|
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
March 31,
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
Collaborative
development revenue
|
$
|
1,454
|
|
$
|
1,175
|
Product supply
revenue
|
126
|
|
38
|
Licensing
revenue
|
5,002
|
|
—
|
Total
revenues
|
6,582
|
|
1,213
|
Operating
expenses:
|
|
|
|
Cost of
revenue
|
1,000
|
|
—
|
Research and
development
|
20,456
|
|
15,844
|
General and
administrative
|
17,131
|
|
7,138
|
Total operating
expenses
|
38,587
|
|
22,982
|
Loss from
operations
|
(32,005)
|
|
|
(21,769)
|
|
Interest
expense
|
(1,100)
|
|
|
(1,357)
|
|
Other income
(expense), net
|
(49)
|
|
753
|
Loss before provision
for income taxes
|
(33,154)
|
|
|
(22,373)
|
Provision for
income taxes
|
$
|
1
|
|
|
$
|
—
|
|
Net
loss
|
$
|
(33,155)
|
|
|
$
|
(22,373)
|
|
Net loss per
common share, basic and diluted
|
$
|
(0.34)
|
|
$
|
(0.25)
|
Shares used in
computing net loss per share - basic and diluted
|
97,179,241
|
|
88,880,658
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ardelyx-reports-first-quarter-2021-financial-results-and-recent-business-highlights-301285361.html
SOURCE Ardelyx