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 financial results for the first quarter ended
March 31, 2024 and provided a business update.
“The first quarter of 2024 marked an important milestone for
Ardelyx as a commercial company. We continued to execute our
disruptive approach to commercializing IBSRELA and XPHOZAH by
targeting patients in established therapeutic areas who continue to
have unmet treatment needs that can be addressed with our
first-in-class medicines,” said Mike Raab, president and chief
executive officer of Ardelyx. “We drove substantial topline growth
as a result of the continued commercial performance of IBSRELA and
the incredibly strong launch of XPHOZAH. At the same time, we
thoughtfully managed our expenses, ending the quarter with a strong
cash position, enabling us to invest in expanding our market
position.”
IBSRELA® (tenapanor)
records $28.4 million in net
product sales revenue in Q1
2024U.S. net product sales revenue for IBSRELA
during the first quarter of 2024 was $28.4 million, reflecting
significant year-over-year growth as well as quarter-over-quarter
growth. Demand for IBSRELA continued during the quarter, including
new and refill prescription growth along with expansion of new and
repeat writing healthcare providers.
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 progresses, records
$15.2 million net product sales
revenue during Q1
2024Following approval by the U.S. Food and Drug
Administration of XPHOZAH in October 2023, Ardelyx continued to see
a strong response from the nephrology community. U.S. net product
sales revenue during Q1 2024 was $15.2 million, the first full
quarter of sales following the product’s launch in November 2023.
Spherix Global Insights, a premier market research firm that
publishes independent, syndicated monthly tracking research,
reports high levels of awareness, intent to adopt and satisfaction
with XPHOZAH in the April 2024 LaunchDynamix report. Among the 77
nephrologists surveyed, 98% rate XPHOZAH as an advance over
currently available hyperphosphatemia therapies. 56% of surveyed
nephrologists report initiating a patient on XPHOZAH, and among
those reported users, 98% report satisfaction with treatment.
Other Corporate Developments
- In March, the company announced the appointment of veteran
biopharma executive Mike Kelliher as Executive Vice President,
Corporate Development and Strategy.
First Quarter 2024
Financial Results
- Cash Position: As of March 31, 2024, the
company had total cash, cash equivalents and short-term investments
of $202.6 million, as compared to total cash, cash equivalents
and short-term investments of $184.3 million as of
December 31, 2023. During the quarter ended March 31,
2024, the company drew $49.8 million in net proceeds under its
term loan with SLR Investment Corp.
- Revenues: Total revenue for the quarter ended
March 31, 2024 was $46.0 million, compared to
$11.4 million in total revenue during the quarter ended
March 31, 2023, primarily reflecting increased net product
sales and product supply revenue.
- IBSRELA U.S. net product sales revenue was $28.4 million,
compared to $11.4 million during the same period of 2023.
- XPHOZAH U.S. net product sales revenue was $15.2 million,
with no comparable revenue during the same period of 2023.
- Product supply revenue was $2.1 million, compared to $2
thousand during the same period of 2023.
- Licensing revenue was $17 thousand, compared to $12 thousand
during the same period of 2023.
- Non-cash royalty revenue related to the sale of future
royalties was $0.4 million, with no comparable revenue during
the same period of 2023.
- R&D Expenses: Research and development
expenses were $10.6 million for the quarter ended
March 31, 2024, compared to $9.1 million for the quarter
ended March 31, 2023.
- SG&A Expenses: Selling, general and
administrative expenses were $53.0 million for the quarter
ended March 31, 2024, an increase of $26.2 million
compared to $26.8 million for the quarter ended March 31,
2023. The increase in selling, general and administrative expenses
was primarily due to increased costs associated with the ongoing
commercialization of IBSRELA and XPHOZAH.
- Net Loss: Net loss for the quarter ended
March 31, 2024 was $26.5 million, or $(0.11) per share,
compared to net loss of $26.8 million, or $(0.13) per share,
for the quarter ended March 31, 2023. The net loss for the
first quarter of 2024 included share-based compensation expense of
$7.6 million and non-cash interest expense related to the sale
of future royalties of $1.7 million.
Conference Call DetailsThe company will host a
conference call today, May 2, 2024, at 4:30 PM ET to discuss
today’s announcement. To participate in the conference call, please
dial (844) 481-2838 (domestic) or (412) 317-1858 (international)
and ask to be joined into the Ardelyx call. 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 (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)
CONTRAINDICATIONS
XPHOZAH 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 ArdelyxArdelyx 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
commercializes 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 current
expectation for U.S. net product sales revenue for IBSRELA for full
year 2024. 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 Annual Report on Form 10-K filed with the Securities and
Exchange Commission on May 2, 2024, 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, Inc.Condensed Balance
Sheets(In thousands) |
|
March 31, 2024 |
|
December 31, 2023 |
|
(Unaudited) |
|
|
(1) |
Assets |
|
|
|
Cash and cash equivalents |
$ |
36,147 |
|
$ |
21,470 |
Investments |
|
166,431 |
|
|
162,829 |
Accounts receivable |
|
28,162 |
|
|
22,031 |
Prepaid commercial manufacturing |
|
5,519 |
|
|
18,925 |
Prepaid commercial manufacturing, non-current |
|
4,235 |
|
|
4,235 |
Inventory, current |
|
9,813 |
|
|
12,448 |
Inventory, non-current |
|
69,045 |
|
|
37,039 |
Property and equipment, net |
|
1,019 |
|
|
1,009 |
Right-of-use assets |
|
4,641 |
|
|
5,589 |
Prepaid and other assets |
|
17,370 |
|
|
12,004 |
Total assets |
$ |
342,382 |
|
$ |
297,579 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Accounts payable |
$ |
17,277 |
|
$ |
11,138 |
Accrued compensation and benefits |
|
6,727 |
|
|
12,597 |
Current portion of operating lease liability |
|
4,314 |
|
|
4,435 |
Deferred revenue |
|
18,689 |
|
|
15,826 |
Accrued expenses and other liabilities |
|
21,991 |
|
|
15,041 |
Operating lease liability, net of current portion |
|
778 |
|
|
1,725 |
Long-term debt, net of current portion |
|
99,834 |
|
|
49,822 |
Deferred royalty obligation related to the sale of future
royalties |
|
21,881 |
|
|
20,179 |
Stockholders' equity |
|
150,891 |
|
|
166,816 |
Total liabilities and stockholders' equity |
$ |
342,382 |
|
$ |
297,579 |
(1) Derived from the audited financial statements included in the
Company’s Annual Report on Form 10-K for the year ended
December 31, 2023. |
Ardelyx, Inc.Condensed Statements of
Operations(Unaudited)(In thousands,
except share and per share amounts) |
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenues: |
|
|
|
Product sales, net: |
|
|
|
IBSRELA |
$ |
28,361 |
|
|
$ |
11,355 |
|
XPHOZAH |
|
15,151 |
|
|
|
— |
|
Total product sales, net |
|
43,512 |
|
|
|
11,355 |
|
Product supply revenue |
|
2,126 |
|
|
|
2 |
|
Licensing revenue |
|
17 |
|
|
|
12 |
|
Non-cash royalty revenue related to the sale of future
royalties |
|
368 |
|
|
|
— |
|
Total revenues |
|
46,023 |
|
|
|
11,369 |
|
Cost of goods
sold: |
|
|
|
Cost of product sales |
|
1,013 |
|
|
|
372 |
|
Other cost of revenue |
|
6,115 |
|
|
|
1,165 |
|
Total cost of goods sold |
|
7,128 |
|
|
|
1,537 |
|
Operating
expenses: |
|
|
|
Research and development |
|
10,579 |
|
|
|
9,093 |
|
Selling, general and administrative |
|
52,994 |
|
|
|
26,803 |
|
Total operating expenses |
|
63,573 |
|
|
|
35,896 |
|
Loss from operations |
|
(24,678 |
) |
|
|
(26,064 |
) |
Interest expense |
|
(2,356 |
) |
|
|
(1,028 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(1,702 |
) |
|
|
(969 |
) |
Other income, net |
|
2,339 |
|
|
|
1,302 |
|
Loss before provision
for income taxes |
|
(26,397 |
) |
|
|
(26,759 |
) |
Provision for income
taxes |
|
121 |
|
|
|
14 |
|
Net loss |
$ |
(26,518 |
) |
|
$ |
(26,773 |
) |
Net loss per share of
common stock - basic and diluted |
$ |
(0.11 |
) |
|
$ |
(0.13 |
) |
Shares used in
computing net loss per share - basic and diluted |
|
233,065,960 |
|
|
|
207,023,127 |
|
Ardelyx (NASDAQ:ARDX)
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