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 fourth quarter and full
year ended December 31, 2023 and provided a business update.
“Ardelyx enters 2024 with tremendous commercial and operational
momentum. We finished 2023 with a strong revenue performance as
both IBSRELA and XPHOZAH launches continue to exceed expectations.
We will look to significantly expand our position within their
respective markets in 2024,” said Mike Raab, president and chief
executive officer of Ardelyx. “We have two first-in-class therapies
with strong clinical profiles where patients continue to have unmet
treatment needs. We will focus on executing our commercial
approach, which has proven to be effective, increasing our
investment in IBSRELA to help more patients and increase market
share, while simultaneously advancing the launch of XPHOZAH. We are
well-capitalized, we are working to establish a track record of
delivering consistent results, and we believe we have opportunities
for additional value creation in 2024.”
IBSRELA® (tenapanor)
finishes 2023 with $80.1 million in net product sales revenue,
$28.1 million in Q4 2023U.S. net product sales revenue for
the first full calendar year of commercialization of IBSRELA was
$80.1 million. During the fourth quarter of 2023, IBSRELA U.S. net
product sales revenue was $28.1 million, reflecting 26% growth
compared to the third quarter of 2023. In January, Ardelyx
announced that it expects IBSRELA to achieve greater than 10
percent share of the prescription irritable bowel syndrome with
constipation (IBS-C) market 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 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)
launched in November 2023, records $2.5 million net product sales
revenue during Q4 2023Following approval by the U.S. Food
and Drug Administration (FDA) 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 in the
fourth quarter of 2023 were $2.5 million.
Today, the company announced the planned initiation of a
long-term, prospective, observational cohort study designed to
collect real-world evidence for XPHOZAH. The objective of the study
is to evaluate the impact of an XPHOZAH-based regimen (XBR) in a
real-world setting, in patients with hyperphosphatemia on
maintenance dialysis who were not controlled on binder therapy. The
study will follow patients in the United States for a period of up
to three years.
Other Corporate Developments
- The company recently released its 2023 Environmental, Social
and Governance (ESG) report, demonstrating the company’s commitment
and progress towards initiatives and best practices that build a
more equitable and sustainable organization. The report is
available on the company’s website.
- Kyowa Kirin Co., Ltd. announced that tenapanor, marketed as
PHOZEVEL®, will be available to patients in Japan as of February
20, 2024. In September 2023, Ardelyx and Kyowa Kirin announced that
PHOZEVEL received approval from the Japanese Ministry of Health,
Labour and Welfare for the New Drug Application for tenapanor for
the improvement of hyperphosphatemia in adult patients with chronic
kidney disease (CKD) on dialysis.
- In January, the company hosted a Key Opinion Leader Discussion
regarding the IBS-C treatment landscape with Philip Schoenfeld,
M.D., MS Ed, MSc, Chief (Emeritus) of the Gastroenterology Section
at the John D. Dingell VA Medical Center in Detroit, Mich. The
event webcast is archived on the company’s website.
- In November, the company announced that XPHOZAH has been
granted Orphan Drug Designation by the U.S. FDA for the treatment
of pediatric hyperphosphatemia.
- The company had a significant presence at the American Society
of Nephrology Kidney Week 2023 meeting in Philadelphia from
November 1-5, 2023. The company presented four posters providing
additional data highlighting the safety and efficacy of XPHOZAH. In
addition, the company’s commercial partner in Japan, Kyowa Kirin,
presented two posters. The company also sponsored an Exhibitor
Spotlight titled “A New Paradigm: Rethinking Hyperphosphatemia
Management,” where Arnold Silva, M.D., Ph.D., director of Home and
Peritoneal Dialysis Programs at the Boise Kidney & Hypertension
Institute, and David Spiegel, M.D., vice president of nephrology at
Ardelyx, led a discussion on important clinical considerations in
managing CKD patients with hyperphosphatemia.
Full Year 2023 Financial Results
- Cash Position: As of December 31, 2023, the
company had total cash, cash equivalents and short-term investments
of $184.3 million, compared to total cash, cash equivalents and
short-term investments of $123.9 million as of December 31, 2022.
During the quarter ended December 31, 2023, the company drew $22.4
million in net proceeds under its term loan with SLR Investment
Corp. Subsequent to December 31, in January 2024, the company
received a $3.0 million milestone payment from Fosun Pharma
following the U.S. approval of XPHOZAH.
- Revenues: Total revenues for the year ended
December 31, 2023 were $124.5 million, compared to $52.2 million in
total revenues in 2022, reflecting increased net product sales,
licensing revenues and product supply revenue. U.S. net product
sales revenue for IBSRELA was $80.1 million, compared to $15.6
million in 2022. U.S. net product sales revenue in 2023 for XPHOZAH
was $2.5 million following its commercial launch in November 2023.
Licensing revenue was $35.8 million in the year, including $30.0
million in milestone and license agreement amendment payments from
Kyowa Kirin following the approval of tenapanor for
hyperphosphatemia in Japan, as well as $5.0 million in milestone
payments from Fosun Pharma related to the acceptance of the New
Drug Application for tenapanor for the control of serum phosphorus
in adult patients with CKD on dialysis in China and the FDA
approval of XPHOZAH in the U.S. Product supply revenue was $6.1
million, compared to product supply revenue of $1.5 million in
2022.
- R&D Expenses: Research and development
expenses were $35.5 million for the year ended December 31, 2023,
compared to $35.2 million for the year ended December 31,
2022.
- SG&A Expenses: Selling, general and
administrative expenses were $134.4 million for the year ended
December 31, 2023, an increase of $57.8 million compared to $76.6
million for the year ended December 31, 2022. The increase in
selling, general and administrative expenses was primarily due to
increased costs associated with the ongoing commercialization of
IBSRELA and commercial activities to prepare for and launch
XPHOZAH.
- Net Loss: Net loss for the year ended December
31, 2023, was $66.1 million, or $(0.30) per share, compared to net
loss of $67.2 million, or $(0.42) per share, for the year ended
December 31, 2022. The net loss for the full year 2023 included
share-based compensation expense of $13.5 million, non-cash
interest expense related to the sale of future royalties of $3.9
million and a non-cash impairment of a lease right of use asset of
$0.4 million.
Conference Call DetailsThe company will host a
conference call today, February 22, 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
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 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 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 expectation
regarding opportunities for continued IBSRELA and XPHOZAH adoption,
the potential growth of market share in their respective markets,
the potential market share for IBSRELA and annual U.S. net product
sales revenue at peak; and projected 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 February 22, 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) |
|
|
December 31, 2023 |
|
December 31, 2022 |
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
21,470 |
|
|
$ |
96,140 |
|
Investments |
|
162,829 |
|
|
|
27,769 |
|
Accounts receivable |
|
22,031 |
|
|
|
7,733 |
|
Prepaid commercial manufacturing |
|
18,925 |
|
|
|
13,567 |
|
Prepaid commercial manufacturing, non-current |
|
4,235 |
|
|
|
— |
|
Inventory, current |
|
12,448 |
|
|
|
3,282 |
|
Inventory, non-current |
|
37,039 |
|
|
|
25,064 |
|
Property and equipment, net |
|
1,009 |
|
|
|
1,223 |
|
Right-of-use assets |
|
5,589 |
|
|
|
9,295 |
|
Prepaid and other assets |
|
12,004 |
|
|
|
5,993 |
|
Total assets |
$ |
297,579 |
|
|
$ |
190,066 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Accounts payable |
$ |
11,138 |
|
|
$ |
10,859 |
|
Accrued compensation and benefits |
|
12,597 |
|
|
|
7,548 |
|
Current portion of operating lease liability |
|
4,435 |
|
|
|
3,894 |
|
Current portion of long-term debt |
|
— |
|
|
|
26,711 |
|
Deferred revenue |
|
15,826 |
|
|
|
13,236 |
|
Accrued expenses and other liabilities |
|
15,041 |
|
|
|
12,380 |
|
Operating lease liability, net of current portion |
|
1,725 |
|
|
|
5,855 |
|
Long-term debt, net of current portion |
|
49,822 |
|
|
|
— |
|
Deferred royalty obligation related to the sale of future
royalties |
|
20,179 |
|
|
|
11,254 |
|
Stockholders' equity |
|
166,816 |
|
|
|
98,329 |
|
Total liabilities and stockholders' equity |
$ |
297,579 |
|
|
$ |
190,066 |
|
(1) Derived from the audited financial statements included in
the Company’s Annual Report on Form 10-K for the year
ended December 31, 2022.
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net: |
|
|
|
|
|
|
|
IBSRELA |
$ |
28,113 |
|
|
$ |
8,701 |
|
|
$ |
80,062 |
|
|
$ |
15,600 |
|
XPHOZAH |
|
2,464 |
|
|
|
— |
|
|
|
2,464 |
|
|
|
— |
|
Total product sales, net |
|
30,577 |
|
|
|
8,701 |
|
|
|
82,526 |
|
|
|
15,600 |
|
Product supply revenue |
|
767 |
|
|
|
469 |
|
|
|
6,121 |
|
|
|
1,527 |
|
Licensing revenue |
|
3,019 |
|
|
|
35,008 |
|
|
|
35,809 |
|
|
|
35,031 |
|
Total revenues |
|
34,363 |
|
|
|
44,178 |
|
|
|
124,456 |
|
|
|
52,158 |
|
Cost of goods
sold: |
|
|
|
|
|
|
|
Cost of product sales |
|
815 |
|
|
|
279 |
|
|
|
2,323 |
|
|
|
566 |
|
Other cost of revenue |
|
4,262 |
|
|
|
2,883 |
|
|
|
15,472 |
|
|
|
3,551 |
|
Total cost of goods sold |
|
5,077 |
|
|
|
3,162 |
|
|
|
17,795 |
|
|
|
4,117 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
9,524 |
|
|
|
9,142 |
|
|
|
35,536 |
|
|
|
35,201 |
|
Selling, general and administrative |
|
47,748 |
|
|
|
19,731 |
|
|
|
134,401 |
|
|
|
76,599 |
|
Total operating expenses |
|
57,272 |
|
|
|
28,873 |
|
|
|
169,937 |
|
|
|
111,800 |
|
Loss from operations |
|
(27,986 |
) |
|
|
12,143 |
|
|
|
(63,276 |
) |
|
|
(63,759 |
) |
Interest expense |
|
(1,740 |
) |
|
|
(991 |
) |
|
|
(4,950 |
) |
|
|
(3,400 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(1,065 |
) |
|
|
(832 |
) |
|
|
(3,924 |
) |
|
|
(1,673 |
) |
Other income, net |
|
2,322 |
|
|
|
375 |
|
|
|
6,630 |
|
|
|
1,633 |
|
(Loss) income before
provision for income taxes |
|
(28,469 |
) |
|
|
10,695 |
|
|
|
(65,520 |
) |
|
|
(67,199 |
) |
Provision for income
taxes |
|
333 |
|
|
|
— |
|
|
|
547 |
|
|
|
8 |
|
Net (loss)
income |
$ |
(28,802 |
) |
|
$ |
10,695 |
|
|
$ |
(66,067 |
) |
|
$ |
(67,207 |
) |
Net (loss) income per
share of common stock - basic and diluted |
$ |
(0.12 |
) |
|
$ |
0.06 |
|
|
$ |
(0.30 |
) |
|
$ |
(0.42 |
) |
Shares used in
computing net (loss) income per share - basic |
|
232,253,351 |
|
|
|
192,430,121 |
|
|
|
219,331,253 |
|
|
|
158,690,083 |
|
Shares used in
computing net (loss) income per share - diluted |
|
232,253,351 |
|
|
|
193,840,751 |
|
|
|
219,331,253 |
|
|
|
158,690,083 |
|
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