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 an update on the company’s progress in 2023 and
initial expectations for 2024.
“2023 was a landmark year for Ardelyx, marking our first full
year as a commercial entity and the approval and launch of our
second first-in-class product. XPHOZAH® joins IBSRELA in our
portfolio of important treatment options for patients with unmet
needs,” said Mike Raab, president and chief executive officer. “We
consistently grew sales of IBSRELA quarter-over-quarter and
finished 2023 with strong revenue performance. We are poised to
continue with a growth trend in 2024. At the same time, we are
seeing a positive initial response to XPHOZAH and are focused on
driving awareness and adoption of this important, new medication
and establishing its role within the hyperphosphatemia treatment
paradigm.”
Raab continued, “2024 will be a year when we further our efforts
to shape the future of Ardelyx. We will continue to prioritize
growing sales of our marketed therapies, while we also seek to
advance our business through investments in internal research &
development programs, international expansion and external
partnerships. We demonstrated in 2023 that we can deliver strong
results, and expect to do the same in 2024.”
IBSRELA® (tenapanor)
Preliminary 2023 Revenue, 2024 Guidance and Revised Peak Sales
ExpectationsU.S. net product sales revenue for the first
full calendar year of commercialization of IBSRELA is expected to
be approximately $80 million, subject to adjustment in connection
with preparation of audited financial statements, following
consistent quarter-over-quarter growth and strong performance
across all key indicators, including new and repeat writers and new
and refill prescriptions. Ardelyx expects IBSRELA to achieve
greater than ten percent market share at peak and generate more
than $1.0 billion in annual U.S. net product sales revenue before
patent term expiration. In 2024, the company will continue to
invest to support future realization of the full potential for
IBSRELA, including the expansion of the IBSRELA sales team,
additional promotional programming and omnichannel digital
capabilities, increased sampling availability, and expanded support
provided by the ArdelyxAssist™ patient services program.
Ardelyx currently expects full-year 2024 U.S. net product sales
revenue for IBSRELA to be between $140.0 and $150.0 million.
XPHOZAH® (tenapanor)
Launch Progress and Preliminary 2023 RevenueFollowing
approval by the U.S. Food and Drug Administration of XPHOZAH in
October 2023 and launch in November 2023, Ardelyx has seen a strong
initial response from the nephrology community. U.S. net product
sales revenue for the first quarter of commercialization of XPHOZAH
is expected to be approximately $2.5 million, subject to adjustment
in connection with preparation of audited financial statements.
Strong Cash Position As of December 31, 2023,
the company had total cash, cash equivalents and short-term
investments of approximately $184 million (unaudited). Ardelyx
had approximately 232 million shares outstanding as of December 31,
2023.
Webcast DetailsThe company will host a live
event and webcast today, January 8, 2024, at 7:00 p.m. ET / 4:00
p.m. PT. The event will include a management update on IBSRELA, the
company’s FDA approved treatment for irritable bowel syndrome with
constipation (IBS-C), as well as a Key Opinion Leader discussion
regarding the IBS-C treatment landscape with Philip Schoenfeld, MD,
MS Ed, MSc, Chief (Emeritus) of the Gastroenterology Section at the
John D. Dingell VA Medical Center in Detroit, Mich. The webcast can
be accessed by visiting the Investor page of the company's website,
www.ardelyx.com, and will be available on the website for at least
30 days following the call.
IMPORTANT SAFETY INFORMATION (IBSRELA)
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC
PATIENTSIBSRELA 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 PRECAUTIONSRisk 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.
IMPORTANT SAFETY INFORMATION
(XPHOZAH)CONTRAINDICATIONSXPHOZAH is
contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal
obstruction
WARNINGS AND
PRECAUTIONSDiarrhea Patients may
experience severe diarrhea. Treatment with XPHOZAH should be
discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS Diarrhea, which
occurred in 43-53% of patients, was the only adverse reaction
reported in at least 5% of XPHOZAH-treated patients with CKD on
dialysis across trials. The majority of diarrhea events in the
XPHOZAH-treated patients were reported to be mild-to-moderate in
severity and resolved over time, or with dose reduction. Diarrhea
was typically reported soon after initiation but could occur at any
time during treatment with XPHOZAH. Severe diarrhea was reported in
5% of XPHOZAH-treated patients in these trials.
INDICATION XPHOZAH (tenapanor), 30 mg BID, is
indicated to reduce serum phosphorus in adults with chronic kidney
disease (CKD) on dialysis as add-on therapy in patients who have an
inadequate response to phosphate binders or who are intolerant of
any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing
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 has two commercial products approved in the United States,
IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), as well as
early-stage pipeline candidates. Ardelyx has agreements for the
development and commercialization of tenapanor outside of the U.S.
Kyowa Kirin has received approval for PHOZEVEL® (tenapanor) for
hyperphosphatemia in Japan. A New Drug Application for tenapanor
for hyperphosphatemia has been submitted in China with Fosun
Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For
more information, please visit https://ardelyx.com/ and connect
with us on X (formerly known as Twitter), LinkedIn and
Facebook.
Forward Looking StatementsTo 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 opportunities for continued IBSRELA adoption, the
potential market share for IBSRELA and annual U.S. net product
sales revenue at peak; Ardelyx’s current expectation for net
product sales revenue for IBSRELA for full year 2023; projected net
product sales revenue for IBSRELA for full year 2024; Ardelyx’s
current expectation for net product sales revenue for XPHOZAH for
the fourth quarter 2023; and Ardelyx’s current expectation
regarding its cash position at December 31, 2023. 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 development of, regulatory process for, and
commercialization of drugs in the U.S. and internationally. 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 October 31, 2023, and its future current
and periodic reports to be filed with the Securities and Exchange
Commission.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
Ardelyx (NASDAQ:ARDX)
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