Conference Call Scheduled for 4:30 PM Eastern Time Today
WALTHAM,
Mass., May 5, 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 provided
a business update and reported financial results for the first
quarter ended March 31, 2022.
"Ardelyx is off to a great start in 2022 with the commercial
launch of IBSRELA®, our first-in-class, novel therapy
for the treatment of IBS-C in adults," said Mike Raab, president and chief executive officer
of Ardelyx. "Initial channel stocking began in late March, the
sales force is mobilized across the country, and early response to
the product as a new treatment option has been positive. In
parallel, we continue to persist in our pursuit of FDA approval for
XPHOZAH®, our first-in-class, phosphate absorption
inhibitor, and received notification from the FDA that an advisory
committee meeting will be convened to get further input from
experts, augmented with clinicians familiar with the clinical
management of hyperphosphatemia."
Recent Business Highlights
- On April 4, 2022, the company
announced the launch of IBSRELA (tenapanor), the first and only
NHE3 inhibitor for the treatment of irritable bowel syndrome with
constipation (IBS-C) in adults. IBSRELA is the first FDA-approved
product for Ardelyx. Commercial efforts are focused on the
9,000 HCPs who account for 50% of the prescriptions of IBS-C
indicated products, with broad-based distribution, a targeted
specialty sales force, and omnichannel tactics. Marketing messages
center on the multifactorial pathophysiology of IBS-C, and the role
novel mechanism IBSRELA can play to address important medical unmet
needs.
- The company presented multiple presentations at the National
Kidney Foundation 2022 Spring Clinical Meetings, in Boston, MA on April
6-10, 2022, covering additional data further supporting the
efficacy and safety of XPHOZAH, an investigational, first-in-class,
phosphate absorption inhibitor for the control of serum phosphorus
in adult patients with chronic kidney disease (CKD) on
dialysis.
- On April 11, 2022, the company
announced it reached an agreement with its Japanese collaboration
partner, Kyowa Kirin Co. Ltd., to amend the license agreement,
originally executed in 2017. Under the amendment, in consideration
for a reduction in the royalty rate due Ardelyx upon net
sales in Japan, Kyowa Kirin has agreed to
pay Ardelyx consideration of up to an
additional U.S. $40 million payable in two tranches.
The first payment is due following Kyowa Kirin's filing with
the Japanese Ministry Health, Labour and Welfare
(MHLW) of its application for marketing approval for tenapanor and
the second payment is due following MHLW's approval to market
tenapanor for hyperphosphatemia in Japan. Kyowa Kirin is
finalizing its Phase 3 clinical program for tenapanor for
hyperphosphatemia and has disclosed its current expectation to file
for approval with MHLW in the second half of 2022 and its current
expectation that it will receive a decision from MHLW regarding its
application in the second half of 2023. The royalty rate will be
reduced from the high-teens to low-double digits for a two-year
period of time following the first commercial sale in Japan, and then to mid-single digits for the
remainder of the royalty term.
- On April 25, 2022, the company
announced that the Office of New Drugs (OND), Center for Drug
Evaluation and Research (CDER) of the U.S. Food and Drug
Administration (FDA), has provided an interim response to Ardelyx's
second level of appeal of the Complete Response Letter (CRL)
received on July 28, 2021, for
XPHOZAH. The OND noted that additional input from the
Cardiovascular and Renal Drug Advisory Committee augmented with
expert clinicians would be valuable in further considering the
clinical meaningfulness of the phosphate lowering effect
demonstrated in Ardelyx's Phase 3 clinical program for
XPHOZAH.
First Quarter 2022 Financial Results
- Cash Position: As of March 31, 2022, we had total
cash, cash equivalents and investments of $89.7 million, as compared to total cash,
cash equivalents and investments of $116.7 million as of December 31,
2021.
- Product Sales: We recognized our first commercial
product sales, net for IBSRELA during March
2022 in the amount of $0.5
million.
- Collaboration Revenue: We generated $18 thousand in
collaboration revenue for the quarter ended March 31, 2022, as
compared to $6.6 million for the
quarter ended March 31, 2021. The decrease in our
collaboration revenue was primarily the result of a $5.0 million development milestone which we
earned in 2021, as well as recognition of the previously received
upfront payment from the KKC 2019 research and collaboration
agreement that was fully earned and recognized as revenue as of
December 31, 2021.
- R&D Expenses: Research and development expenses were
$8.9 million for the quarter
ended March 31, 2022, a decrease of $11.6 million, or 56.7%, compared to
$20.5 million for the quarter
ended March 31, 2021. Research and development expenses
included non-cash stock compensation expense of approximately
$1.2 million and $1.1 million in the quarters ended March 31, 2022, and 2021, respectively. The
decrease in our R&D expenses is primarily the result of lower
clinical study costs from the OPTIMIZE study, lower tenapanor
manufacturing expenses as we have begun to capitalize costs
associated with the production of IBSRELA to inventory, and lower
expenses for research following the elimination of our research
function in the fourth quarter of 2021.
- SG&A Expenses: Selling, general and
administrative expenses were $19.3 million for the quarter ended
March 31, 2022, an increase of $2.2 million, or 12.9%, compared to
$17.1 million for the quarter
ended March 31, 2021. Selling, general and administrative
expenses included non-cash stock compensation expense of
approximately $2.5 million and
$2.0 million in the quarters ended
March 31, 2022, and 2021,
respectively. The increase in selling, general and administrative
expenses was primarily due to an increase in costs associated with
preparations for the commercial launch of IBSRELA.
- Net Loss: Net loss for the quarter ended March 31,
2022, was $28.1 million, or
$0.21 per share, compared to
$33.2 million, or $0.34 per share, for the quarter ended
March 31, 2021.
Conference Call Details
The company will host a conference call today, May 5, 2022, at 4:30 PM
ET to review its financial results and provide a business
overview. To participate in the conference call, please dial (866)
777-2509 (domestic) or (412) 317-5413 (international) and ask to be
joined into the Ardelyx, Inc. call. A webcast of the call can also
be accessed by visiting the Investor page of the company's website
at 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 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. 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 secretagogue program, 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 Ardelyx's current
expectation regarding the FDA's plan to convene an Advisory
Committee meeting to consider the NDA for XPHOZAH, Ardelyx's belief
regarding the role that IBSRELA can play in addressing unmet
medical needs in IBS-C, Ardelyx's expectation regarding the timing
of Kyowa Kirin's filing for marketing approval for tenapanor for
hyperphosphatemia in Japan, and
Ardelyx's expectations regarding the potential timing for Kyowa
Kirin'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 drug development process and the regulatory
approval process, including uncertainties in the drug development
and regulatory processes in Japan,
and risks and uncertainties associated with the commercialization
of drugs in the United States.
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 5,
2022, 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, 2022
|
|
December 31, 2021
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
47,077
|
|
$
72,428
|
Investments
|
42,627
|
|
44,261
|
Accounts
receivable
|
4,394
|
|
502
|
Inventory
|
3,487
|
|
—
|
Property
and equipment, net
|
2,045
|
|
2,362
|
Right-of-use assets
|
11,910
|
|
12,752
|
Prepaid
and other assets
|
17,868
|
|
17,608
|
Total assets
|
$
129,408
|
|
$
149,913
|
|
|
|
|
Liabilities and stockholders'
equity
|
|
|
|
Accounts
payable
|
$
5,030
|
|
$
4,277
|
Accrued
compensation and benefits
|
6,304
|
|
5,422
|
Current
portion of operating lease liability
|
3,592
|
|
3,492
|
Current
portion of long-term debt
|
26,139
|
|
32,264
|
Deferred
revenue
|
8,563
|
|
4,727
|
Accrued
expenses and other liabilities
|
6,778
|
|
7,366
|
Operating
lease liability, net of current portion
|
8,812
|
|
9,748
|
Stockholders' equity
|
64,190
|
|
82,617
|
Total liabilities and stockholders' equity
|
$
129,408
|
|
$
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 March 31,
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
Product sales, net
|
$
450
|
|
$
—
|
Product supply revenue
|
14
|
|
126
|
Licensing revenue
|
4
|
|
5,002
|
Collaborative development revenue
|
—
|
|
1,454
|
Total revenues
|
468
|
|
6,582
|
Operating expenses:
|
|
|
|
Cost
of revenue
|
85
|
|
1,000
|
Research and development
|
8,851
|
|
20,456
|
Selling, general and administrative
|
19,339
|
|
17,131
|
Total operating expenses
|
28,275
|
|
38,587
|
Loss
from operations
|
(27,807)
|
|
(32,005)
|
Interest expense
|
(746)
|
|
(1,100)
|
Other income (expense), net
|
484
|
|
(49)
|
Loss before provision for income
taxes
|
(28,069)
|
|
(33,154)
|
Provision for income taxes
|
2
|
|
1
|
Net loss
|
$
(28,071)
|
|
$
(33,155)
|
Net loss per common share, basic and
diluted
|
$
(0.21)
|
|
$
(0.34)
|
Shares used in computing net loss per share - basic
and diluted
|
130,934,795
|
|
97,179,241
|
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SOURCE Ardelyx