Conference call scheduled for 4:30 p.m. Eastern Time today
WALTHAM,
Mass., Nov. 3, 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 updates and financial results for the third quarter ended
September 30, 2022.
"We are now a full six months into the launch of
IBSRELA® and are extremely encouraged by the commercial
progress we are making," said Mike
Raab, president, and chief executive officer of Ardelyx.
"Our efforts are reinforcing strong demand and market receptivity
for our novel treatment option in the IBS-C market. We are in a
unique position in the biopharmaceutical industry, demonstrating
our status as an evolving, impressive growth story with many
opportunities ahead. We look forward to continued commercial
progress with IBSRELA and the upcoming FDA Advisory Committee
meeting for XPHOZAH® on November
16, 2022."
Recent Business Highlights and Updates
- The company had a significant presence at the American College
of Gastroenterology 2022 Annual Scientific Meeting (ACG 2022) in
Charlotte, NC on October 21-26. The company presented two posters
which included post-hoc data analyses from its Phase 3 T3MPO trials
and sponsored a Product Theater titled: An Innovative Approach
to the Treatment of Adults with Irritable Bowel Syndrome with
Constipation (IBS-C) where Susan
Lucak, MD, reviewed the multifactorial pathophysiology of
IBS-C, the novel mechanism of action of IBSRELA, and safety and
efficacy data for IBSRELA from the Phase 3 clinical development
program. Finally, the company sponsored a Continuing Medical
Education (CME) program titled: Partnering with Patients,
Personalizing Care for IBS-C, where experts in the field
provided education on disease pathophysiology, diagnosis and
treatment of IBS-C.
- On October 31, the company
announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd, submitted a New
Drug Application (NDA) to the Japanese Ministry of Health, Labour
and Welfare (MHLW) for tenapanor for the improvement of
hyperphosphatemia in adult patients with chronic kidney disease
(CKD) on dialysis. Based on this achievement, in the fourth quarter
of 2022, Ardelyx expects to receive an aggregate of $35 million in milestone payments and payments
associated with the 2022 amendment of the license agreement.
- Earlier today, the company presented two poster presentations
at the American Society of Nephrology (ASN) Meeting, with a third
poster presentation scheduled for November
5th. All three poster presentations highlight
data from the company's three Phase 3 trials (BLOCK, AMPLIFY and
PHREEDOM) in patients with hyperphosphatemia on maintenance
dialysis in the U.S. Additionally, earlier today at ASN, Kyowa
Kirin, presented results of two Phase 3 studies of tenapanor in a
similar patient population in Japan. Kyowa Kirin made a public announcement
with their results which is available here: Kyowa Kirin ASN Press
Release.
Third Quarter 2022 Financial Results
- Cash Position: As of September 30, 2022, the
company had total cash, cash equivalents and investments of
$90.6 million, as compared to
total cash, cash equivalents and investments of $116.7 million as of December 31,
2021.
- Product Sales: Net product sales for IBSRELA were
$4.9 million during the quarter
ended September 30, 2022.
- Collaboration Revenue: The company generated
$0.1 million in collaboration
revenue for the quarter ended September 30, 2022, as compared
to $1.2 million for the quarter
ended September 30, 2021. The decrease in collaboration
revenue was primarily the result of the recognition of the
previously received upfront payment from the 2019 research and
collaboration agreement between the company and Kyowa Kirin that
was fully earned and recognized as revenue as of December 31, 2021.
- R&D Expenses: Research and development expenses were
$7.5 million for the quarter
ended September 30, 2022, a decrease of $16.2 million, or 68.5%, compared to
$23.7 million for the quarter
ended September 30, 2021. Research and development expenses
included non-cash stock compensation expense of approximately
$0.5 million and $0.7 million in the quarters ended
September 30, 2022, and September 30, 2021, respectively.
The decrease in R&D expenses is primarily the result of lower
clinical study costs as a result of the completion of the OPTIMIZE
study, lower tenapanor manufacturing expenses due to the company's
capitalization of costs associated with the production of IBSRELA
to inventory, and lower expenses for research following the
significant reduction in the research function in the fourth
quarter of 2021.
- SG&A Expenses: Selling, general and administrative
expenses were $18.7 million for
the quarter ended September 30, 2022, a decrease of
$1.0 million, or 5.3%, compared
to $19.7 million for the quarter
ended September 30, 2021. Selling, general and administrative
expenses included non-cash stock compensation expense of
approximately $1.4 million and
$1.5 million in the quarters
ended September 30, 2022, and September 30, 2021,
respectively. The decrease in selling, general and administrative
expenses was primarily due to a reduction in ongoing and one-time
costs as a result of the restructuring action carried out during
the third quarter of 2021, offset by increased costs associated
with the continuing commercial launch of IBSRELA during the third
quarter of 2022.
- Net Loss: Net loss for the quarter ended
September 30, 2022 was $22.9 million, or $(0.14) per share, compared to $43.6 million, or $(0.42) per share, for the quarter ended
September 30, 2021.
Conference Call Details
The company will host a conference call today, November 3,
2022, at 4:30 p.m. ET to review its
financial results and provide a business overview. To participate
in the conference call, please dial (866) 374-5140 (domestic) or
(404) 400-0571 (international) and enter the pin 79680409#. Live
audio of the conference call will be simultaneously webcast and
will be available under the Investors section of the company's
website at www.ardelyx.com. The webcast will be archived and
available for replay for 30 days following the call.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF
SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
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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.
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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 distension (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's first approved product,
IBSRELA® (tenapanor) is available in the
United States and Canada.
Ardelyx is developing XPHOZAH® (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 has a Phase 2 potassium lowering compound, RDX013, for the
potential treatment of elevated serum potassium, or hyperkalemia, a
problem among certain patients with kidney and/or heart disease and
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 the potential
commercial and other opportunities for the company, and Ardelyx's
current expectation of the date of the Advisory Committee meeting
to be convened to provide input regarding the clinical
meaningfulness of the phosphate lowering effect observed in the
Phase 3 clinical program for XPHOZAH. 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 commercialization
of drugs, and uncertainties regarding the FDA regulatory 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 3,
2022, 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,
2022
|
|
December 31,
2021
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
61,628
|
|
$
72,428
|
Investments
|
28,995
|
|
44,261
|
Accounts
receivable
|
5,208
|
|
502
|
Inventory, current
portion
|
1,250
|
|
—
|
Property and
equipment, net
|
1,294
|
|
2,362
|
Right-of-use
assets
|
10,182
|
|
12,752
|
Prepaid commercial
manufacturing
|
16,145
|
|
9,406
|
Prepaid and other
assets
|
19,970
|
|
8,202
|
Total
assets
|
$
144,672
|
|
$
149,913
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Accounts
payable
|
$
3,113
|
|
$
4,277
|
Accrued compensation
and benefits
|
7,165
|
|
5,422
|
Current portion of
operating lease liability
|
3,791
|
|
3,492
|
Current portion of
long-term debt
|
26,541
|
|
32,264
|
Deferred
revenue
|
12,563
|
|
4,727
|
Accrued expenses and
other liabilities
|
7,338
|
|
7,366
|
Operating lease
liability, net of current portion
|
6,878
|
|
9,748
|
Deferred royalty
obligation related to the sale of future royalties
|
10,422
|
|
—
|
Stockholders'
equity
|
66,861
|
|
82,617
|
Total liabilities and
stockholders' equity
|
$
144,672
|
|
$
149,913
|
|
(1) Derived from the
audited financial statements included in the Company's Annual
Report on Form 10-K for the year ended December 31,
2021.
|
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,
|
|
2022
|
|
2021
|
|
2022
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|
2021
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
4,885
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|
$
—
|
|
$
6,899
|
|
$
—
|
Product supply
revenue
|
92
|
|
285
|
|
1,058
|
|
411
|
Licensing
revenue
|
9
|
|
2
|
|
23
|
|
5,007
|
Collaborative
development revenue
|
—
|
|
886
|
|
—
|
|
3,650
|
Total
revenues
|
4,986
|
|
1,173
|
|
7,980
|
|
9,068
|
Operating
expenses:
|
|
|
|
|
|
|
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Cost of
revenue
|
732
|
|
—
|
|
955
|
|
1,000
|
Research and
development
|
7,467
|
|
23,695
|
|
26,059
|
|
70,172
|
Selling, general and
administrative
|
18,667
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|
19,714
|
|
56,868
|
|
56,969
|
Total operating
expenses
|
26,866
|
|
43,409
|
|
83,882
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|
128,141
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Loss from
operations
|
(21,880)
|
|
(42,236)
|
|
(75,902)
|
|
(119,073)
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Interest
expense
|
(886)
|
|
(1,216)
|
|
(2,409)
|
|
(3,518)
|
Non-cash interest
expense related to the sale of future royalties
|
(831)
|
|
—
|
|
(841)
|
|
—
|
Other income
(expense), net
|
704
|
|
(134)
|
|
1,258
|
|
664
|
Loss before
provision for income taxes
|
(22,893)
|
|
(43,586)
|
|
(77,894)
|
|
(121,927)
|
Provision for income
taxes
|
—
|
|
1
|
|
8
|
|
4
|
Net
loss
|
$
(22,893)
|
|
$
(43,587)
|
|
$
(77,902)
|
|
$
(121,931)
|
Net loss per common
share, basic and diluted
|
$
(0.14)
|
|
$
(0.42)
|
|
$
(0.53)
|
|
$
(1.21)
|
Shares used in
computing net loss per share - basic and diluted
|
165,104,789
|
|
104,144,606
|
|
147,319,818
|
|
100,480,156
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SOURCE Ardelyx