WALTHAM, Mass., Feb. 28, 2022 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a biopharmaceutical company founded with a mission
to discover, develop and commercialize innovative first-in-class
medicines that meet significant unmet medical needs, today reported
business events and financial results for the fourth quarter and
full year ended December 31,
2021.
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"With a tumultuous 2021 behind us, Ardelyx is positioned to be a
biopharma standout in 2022 with our evolution to a commercial stage
company with our April launch of IBSRELA for the treatment of
irritable bowel syndrome with constipation (IBS-C) in adults," said
Mike Raab, president and chief
executive officer of Ardelyx. "This year we become a
revenue-generating company commercializing a novel mechanism
treatment we developed, with a clear line of sight to breakeven
and, ultimately, profitability for the product, which we believe
will create significant shareholder value. I want to recognize the
entire Ardelyx team whose dedication over the years has brought us
to this critical inflection point. Every single team member has an
unyielding commitment to patients that fuels our mission to bring
to market a diverse pipeline of drug candidates and provide the
company optionality. We are very excited to see our first drug
enter the market and improve the lives of patients with IBS-C."
Recent Business Events
- The company plans to launch IBSRELA (tenapanor), the company's
FDA approved treatment for irritable bowel syndrome with
constipation (IBS-C) in adults, in April of 2022.
- The company's collaboration partner, Kyowa Kirin Co. Ltd.,
(KKC) announced positive Phase 3 results of tenapanor for
hyperphosphatemia in patients on hemodialysis in Japan and plans to file for approval in the
second half of 2022 with potential regulatory approval in the
second half of 2023.
- On February 4, 2022, the company
received an Appeal Denied Letter ("ADL") from the Office of
Cardiology, Hematology, Endocrinology and Nephrology ("OCHEN") of
the U.S. Food and Drug Administration (the "FDA") in response to
its Formal Dispute Resolution Request ("FDRR") submitted in early
December 2021. In February 2022, the company submitted an appeal of
the ADL to the Office of New Drugs ("OND"), Center for Drug
Evaluation and Research. If accepted for consideration, the company
expects a decision on the appeal to the OND in April 2022.
- On February 24, 2022, the company
announced it is paying off the remainder of $25.0 million in principal plus interest
outstanding under the Loan and Security agreement entered into
among the company, Solar Capital Ltd. and Western Alliance Bank in
May 2018, and has entered into a new
term loan with SLR Investment Corp. for $27.5 million, which provides for two years of
interest only payments, and an option for an additional
$22.5 million in term loan debt if
the company receives FDA approval for XPHOZAH® (tenapanor) by
December 31, 2022, and meets certain
net revenue criteria and other conditions. This further extends the
company's cash position in support of the IBSRELA launch.
Full Year 2021 Financial Results
- Cash Position: As of December 31,
2021, we had total cash, cash equivalents and short-term
investments of $116.7 million, as
compared to total cash, cash equivalents and investments of
$188.6 million as of December 31, 2020.
- Revenue: We generated $10.1
million in revenue for the year ended December 31, 2021, an increase of $2.5 million, or 33 percent, compared to
$7.6 million for the year ended
December 31, 2020. The increase in
our revenue was primarily the result of a $5.0 million development milestone which we
earned in 2021 upon the initiation by KKC of Phase 3 clinical
studies in Japan to evaluate
tenapanor for hyperphosphatemia.
- R&D Expenses: Research and development expenses were
$91.1 million for the year ended
December 31, 2021, an increase of
$26.1 million, or 40 percent,
compared to $65.1 million for the
year ended December 31, 2020. The
increase in our R&D expenses is primarily the result of
tenapanor manufacturing costs as well as clinical study costs from
the advancement of our OPTIMIZE study which were partially offset
by lower costs for the PHREEDOM Phase 3 clinical study, which
concluded in the second quarter of 2020. Research and development
expenses included $2.7 million in
severance payments and other employee-related costs associated with
restructuring.
- G&A Expenses: General and administrative expenses
were $72.3 million for the year ended
December 31, 2021, an increase of
$39.2 million, or 118 percent,
compared to $33.2 million for the
year ended December 31, 2020. The
increase in general and administrative expenses was primarily due
to an increase in costs associated with preparations for the
commercial launch of tenapanor. General and administrative
employee-related expenses included $3.5
million in severance payments and other employee-related
costs associated with restructuring.
- Net Loss: Net loss for the year ended December 31, 2021, was $158.2 million, compared to $94.3 million for the year ended December 31, 2020.
Conference Call Details
The company will host a conference call today, February 28, 2022, at 4:30
PM ET to discuss today's announcement. To participate in the
conference call, please call (855) 296-9612 (toll-free) or (920)
663-6277 (toll) and reference call ID number 2790368. A webcast of
the call can also be accessed by visiting the Investor page of the
company's website www.ardelyx.com and will be available on the
website for 30 days following the call.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF
SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
IBSRELA is
contraindicated in patients less than 6 years of age; in
nonclinical studies in young juvenile rats administration of
tenapanor caused deaths presumed to be due to dehydration. Avoid
use of IBSRELA in patients 6 years to less than 12 years of age.
The safety and effectiveness of IBSRELA have not been established
in patients less than 18 years of age.
|
CONTRAINDICATIONS
- IBSRELA is contraindicated in patients less than 6 years of age
due to the risk of serious dehydration.
- IBSRELA is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age.
The safety and effectiveness of IBSRELA in patients less than 18
years of age have not been established. In young juvenile rats
(less than 1 week old; approximate human age equivalent of less
than 2 years of age), decreased body weight and deaths occurred,
presumed to be due to dehydration, following oral administration of
tenapanor. There are no data available in older juvenile rats
(human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12
years of age. Although there are no data in older juvenile rats,
given the deaths in younger rats and the lack of clinical safety
and efficacy data in pediatric patients, avoid the use of IBSRELA
in patients 6 years to less than 12 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in two randomized,
double-blind, placebo-controlled trials of IBS-C. Severe diarrhea
was reported in 2.5% of IBSRELA-treated patients. If severe
diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients
(incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4%
placebo), abdominal distention (3% vs <1%), flatulence (3% vs
1%) and dizziness (2% vs <1%).
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable
Bowel Syndrome with Constipation (IBS-C) in adults.
Please see full Prescribing Information,
including Boxed Warning, for additional risk information.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx received approval for
IBSRELA (tenapanor) with plans to launch in the second quarter of
2022. 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. 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 regarding the timing of a response from OND with
respect to Ardelyx's submission of an appeal from the ADL issued by
OCHEN; Ardelyx's expectations regarding the impact that the
execution of a new loan and security agreement with SLR will have
on Ardelyx's cash position; Ardelyx's expectations regarding the
potential for breakeven and, ultimately, profitability for IBSRELA;
Ardelyx's expectations regarding the impact on shareholder value
that may result from the launch of IBSRELA; Ardelyx's expectations
regarding the timing for filing for marketing approval for
tenapanor for hyperphosphatemia in Japan by Ardelyx's collaboration partner, KKC
and Ardelyx's expectations regarding the potential timing for KKC's
marketing approval in Japan. 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 Formal Dispute Resolution process with the FDA,
uncertainties associated with its capital requirements to fund its
operations, uncertainties in the commercialization of drugs in
the United States, as well as
uncertainties in the drug development and regulatory processes in
Japan. 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 Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 28, 2022, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
Ardelyx, Inc.
|
Condensed Balance
Sheets
|
(In
thousands)
|
|
|
December
31,
|
|
2021
|
|
2020
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
72,428
|
|
$
91,032
|
Investments
|
44,261
|
|
97,566
|
Accounts
receivable
|
502
|
|
—
|
Property and
equipment, net
|
2,362
|
|
1,936
|
Right-of-use
assets
|
12,752
|
|
2,274
|
Prepaid and other
assets
|
17,608
|
|
8,754
|
Total
assets
|
$
149,913
|
|
$
201,562
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts
payable
|
$
4,277
|
|
$
5,626
|
Accrued compensation
and benefits
|
5,422
|
|
5,672
|
Current portion of
operating lease liability
|
3,492
|
|
2,117
|
Loan payable, current
portion
|
32,264
|
|
4,167
|
Deferred
revenue
|
4,727
|
|
4,177
|
Accrued expenses and
other liabilities
|
7,366
|
|
6,657
|
Operating lease
liability, net of current portion
|
9,748
|
|
413
|
Loan payable, net of
current portion
|
—
|
|
46,621
|
Stockholders'
equity
|
82,617
|
|
126,112
|
Total liabilities and
stockholders' equity
|
$
149,913
|
|
$
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
December 31,
|
|
Twelve Months
Ended December 31,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Collaborative
development revenue
|
$
527
|
|
$
1,708
|
|
$
4,177
|
|
$
5,364
|
Product supply
revenue
|
496
|
|
101
|
|
907
|
|
1,501
|
Licensing
revenue
|
6
|
|
—
|
|
5,013
|
|
706
|
Total
revenues
|
1,029
|
|
1,809
|
|
10,097
|
|
7,571
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
—
|
|
4
|
|
1,000
|
|
145
|
Research and
development
|
20,968
|
|
18,105
|
|
91,140
|
|
65,053
|
General and
administrative
|
15,334
|
|
11,343
|
|
72,303
|
|
33,153
|
Total operating
expenses
|
36,302
|
|
29,452
|
|
164,443
|
|
98,351
|
Loss from
operations
|
(35,273)
|
|
(27,643)
|
|
(154,346)
|
|
(90,780)
|
Interest
expense
|
(984)
|
|
(1,314)
|
|
(4,502)
|
|
(5,099)
|
Other income,
net
|
23
|
|
83
|
|
687
|
|
1,568
|
Loss before
provision for income taxes
|
(36,234)
|
|
(28,874)
|
|
$
(158,161)
|
|
$
(94,311)
|
Provision for
income taxes
|
—
|
|
2
|
|
4
|
|
2
|
Net
loss
|
$
(36,234)
|
|
$
(28,876)
|
|
$
(158,165)
|
|
$
(94,313)
|
Net loss per
common share, basic and diluted
|
$
(0.31)
|
|
$
(0.32)
|
|
$
(1.52)
|
|
$
(1.05)
|
Shares used in
computing net loss per share - basic and
diluted
|
115,260,610
|
|
90,988,968
|
|
104,205,645
|
|
89,582,138
|
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SOURCE Ardelyx