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, 2022 and provided a business update.
“2022 was a remarkable year for Ardelyx, having met significant
milestones that demonstrate our deep and profound commitment to
bringing our novel mechanism products to patients in need. In
April, we began the process of launching our first therapy,
IBSRELA, for adult patients with irritable bowel syndrome with
constipation and we are demonstrating significant,
quarter-over-quarter prescription growth. In addition, after the
positive outcome of our appeal process for XPHOZAH, and a
productive Type A meeting with the Food and Drug Administration in
February 2023, we believe we are now on the path to launching
another important medicine in the second half of the year for
patients on dialysis,” said Mike Raab, president and chief
executive officer of Ardelyx. “Our efforts, our commitment to
patients and our tenacity have positioned us well in 2023 as we
continue to build growth and momentum for IBSRELA, execute on our
plans for a successful launch of XPHOZAH, if approved, and create
opportunities to expand our business to support the next phase of
the company’s growth. As evidenced by our continued success with
IBSRELA, we are well on our way to realizing our mission to
discover, develop and commercialize novel mechanism products for
patients with unmet medical needs. We are pleased with our progress
and excited about the opportunity to reach even more patients in
the future.”
Recent Business Highlights
IBSRELA® (tenapanor)
finishes 2022 with $15.6 million in net product sales,
$8.7 million in Q4 2022In March 2022, Ardelyx
launched IBSRELA (tenapanor) for the treatment of irritable bowel
syndrome with constipation (IBS-C) in the United States. The
targeted commercial launch is focused on high-writing physicians
and the patients who experience persistent symptoms, despite
treatment with a prescription therapy for IBS-C. Ardelyx has seen
consistent month-over-month growth trends in both new and refill
prescriptions, supported by data from the independent research firm
Spherix which reported in December that 60% of surveyed
gastroenterologists had adopted IBSRELA with 32% of non-prescribers
intending to adopt within three months.
XPHOZAH® (tenapanor)
prepares for New Drug Application (NDA) resubmission in early Q2
2023In February, Ardelyx participated in a Type A meeting
with members of the U.S. Food and Drug Administration’s (FDA)
Division of Cardiology and Nephrology (DCN) to discuss resubmission
of the NDA for XPHOZAH for the control of serum phosphorus in
patients with chronic kidney disease (CKD) on dialysis. The meeting
was very productive and provided Ardelyx with information required
to complete its NDA resubmission. The company currently intends to
submit the NDA early in the second quarter of 2023. Ardelyx is
preparing to launch XPHOZAH, if approved, in the second half of
2023.
The resubmission of the NDA follows two significant developments
for XPHOZAH that happened in the fourth quarter of 2022, providing
a path to bring XPHOZAH to patients following a prolonged appeal
process to the Complete Response Letter the company received in
July 2021. In November, the Cardiovascular and Renal Drugs Advisory
Committee voted nine to four that the benefits of treatment with
XPHOZAH outweigh its risks for the control of serum phosphorus in
adults with CKD on dialysis when administered as a monotherapy, and
voted ten to two, with one abstention, that the benefits of
treatment with XPHOZAH in combination with phosphate binder
treatment outweigh its risks. Following the favorable outcome of
the Advisory Committee meeting, in December, the FDA’s Office of
New Drugs granted the appeal for XPHOZAH and directed the DCN to
work with Ardelyx to develop an appropriate label.
Other Corporate Developments
- In February, the company released its first 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 society. The report is
available on the company’s website.
- In February, the company reported that it had amended the debt
financing agreement with SLR Investment Corp. it entered into in
February 2022. The senior term loan facility’s March 1, 2027
maturity date is unchanged; however, the interest only period for
the $27.5 million that was drawn at the February 2022 closing may
be extended by one year to March 31, 2025 if certain product
revenue targets are achieved for the year ended 2023 or the company
has received approval by the FDA for the NDA for XPHOZAH on or
before November 30, 2023. In addition, the deadline to borrow an
additional $22.5 million available under the facility has been
extended to December 20, 2023, provided that the company has
received approval by the FDA for the NDA for XPHOZAH on or before
November 30, 2023 and that the company has achieved certain product
revenue targets.
Full Year 2022 Financial Results
- Cash Position: As of December 31, 2022,
the company had total cash, cash equivalents and short-term
investments of $123.9 million, as compared to total cash, cash
equivalents and short-term investments of $116.7 million as of
December 31, 2021. As of February 28, 2023, the company had an
unaudited cash, cash equivalents and short-term investments balance
of $121.0 million, which included gross proceeds of $20.0 million
for the sale of 7.7 million shares of the company’s common stock
which were sold at a weighted average sales price of approximately
$2.60 per share during the period January 1, 2023 to January 12,
2023 under the company’s sales agreement with Jefferies LLC, dated
August 13, 2021, deemed to be “at-the-market offerings.”
- Product Sales: Net product sales for IBSRELA
were $15.6 million during the year ended December 31,
2022.
- Collaboration Revenue: The company generated
$36.6 million in collaboration revenue for the year ended
December 31, 2022, as compared to $10.1 million for the
year ended December 31, 2021. The increase in collaboration
revenue was primarily the result of $35.0 million in milestone
payments and payments under the 2022 amendment to the license
agreement between Ardelyx and Kyowa Kirin Co, Ltd. (Kyowa Kirin),
Ardelyx’s collaboration partner in Japan, earned upon Kyowa Kirin's
submission of a New Drug Application to the Japanese Ministry of
Health, Labour and Welfare for tenapanor for the improvement of
hyperphosphatemia in adult patients with CKD on dialysis. The
company also realized increased product supply revenue in
connection with its obligation to supply drug substance to Kyowa
Kirin under its license agreement with Kyowa Kirin. Partially
offsetting these increases was the full recognition through the end
of 2021 of upfront payments associated with the Research
Collaboration Agreement entered into with Kyowa Kirin.
- R&D Expenses: Research and development
expenses were $35.2 million for the year ended
December 31, 2022, a decrease of $55.9 million compared
to $91.1 million for the year ended December 31, 2021.
Research and development expenses included non-cash stock
compensation expense of approximately $3.2 million and
$4.1 million in the years ended December 31, 2022, and
December 31, 2021, respectively. The decrease in R&D
expenses is primarily due to 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 reduction in the research
function in the fourth quarter of 2021.
- SG&A Expenses: Selling, general and
administrative expenses were $76.6 million for the year ended
December 31, 2022, an increase of $4.3 million compared
to $72.3 million for the year ended December 31, 2021.
Selling, general and administrative expenses included non-cash
stock compensation expense of approximately $7.5 million and
$7.9 million in the years ended December 31, 2022, and
December 31, 2021, respectively. The increase in selling,
general and administrative expenses was primarily due to increased
costs associated with the ongoing commercial launch of IBSRELA
during 2022.
- Net Loss: Net loss for the year ended
December 31, 2022 was $67.2 million, or $(0.42) per
share, compared to net loss of $158.2 million, or $(1.52) per
share, for the year ended December 31, 2021.
Conference Call DetailsThe company will host a
conference call today, March 2, 2023, at 4:30 PM ET to discuss
today's announcement. To participate in the conference call, please
dial (877) 270-2148 (domestic) or (412) 902-6510 (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
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.
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 for the control of serum
phosphorus in adult patients with chronic kidney disease (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. For more information,
please visit https://ardelyx.com/ and connect with us on 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 potential commercial
opportunities and other opportunities for the company, Ardelyx’s
current expectation for both the timing of the NDA submission and
potential FDA approval for XPHOZAH, and the potential extension of
the interest only period for Ardelyx's senior term loan facility.
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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 2, 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
Kimia Keshtbod kkeshtbod@ardelyx.com
Ardelyx, Inc.Condensed Balance
Sheets(In thousands)
|
December 31, 2022 |
|
December 31, 2021 |
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
96,140 |
|
|
$ |
72,428 |
|
Investments |
|
27,769 |
|
|
|
44,261 |
|
Accounts receivable |
|
7,733 |
|
|
|
502 |
|
Prepaid commercial manufacturing |
|
13,567 |
|
|
|
9,406 |
|
Inventory, current |
|
3,282 |
|
|
|
— |
|
Inventory, non-current |
|
25,064 |
|
|
|
— |
|
Property and equipment, net |
|
1,223 |
|
|
|
2,362 |
|
Right-of-use assets |
|
9,295 |
|
|
|
12,752 |
|
Prepaid and other assets |
|
5,993 |
|
|
|
8,202 |
|
Total assets |
$ |
190,066 |
|
|
$ |
149,913 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Accounts payable |
$ |
10,859 |
|
|
$ |
4,277 |
|
Accrued compensation and benefits |
|
7,548 |
|
|
|
5,422 |
|
Current portion of operating lease liability |
|
3,894 |
|
|
|
3,492 |
|
Current portion of long-term debt |
|
26,711 |
|
|
|
32,264 |
|
Deferred revenue |
|
13,236 |
|
|
|
4,727 |
|
Accrued expenses and other liabilities |
|
12,380 |
|
|
|
7,366 |
|
Operating lease liability, net of current portion |
|
5,855 |
|
|
|
9,748 |
|
Deferred royalty obligation related to the sale of future
royalties |
|
11,254 |
|
|
|
— |
|
Stockholders' equity |
|
98,329 |
|
|
|
82,617 |
|
Total liabilities and stockholders' equity |
$ |
190,066 |
|
|
$ |
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 December 31, |
|
Twelve Months Ended December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
8,701 |
|
|
$ |
— |
|
|
$ |
15,600 |
|
|
$ |
— |
|
Product supply revenue |
|
469 |
|
|
|
496 |
|
|
|
1,527 |
|
|
|
907 |
|
Licensing revenue |
|
35,008 |
|
|
|
6 |
|
|
|
35,031 |
|
|
|
5,013 |
|
Collaborative development revenue |
|
— |
|
|
|
527 |
|
|
|
— |
|
|
|
4,177 |
|
Total revenues |
|
44,178 |
|
|
|
1,029 |
|
|
|
52,158 |
|
|
|
10,097 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of revenue |
|
3,162 |
|
|
|
— |
|
|
|
4,117 |
|
|
|
1,000 |
|
Research and development |
|
9,142 |
|
|
|
20,968 |
|
|
|
35,201 |
|
|
|
91,140 |
|
Selling, general and administrative |
|
19,731 |
|
|
|
15,334 |
|
|
|
76,599 |
|
|
|
72,303 |
|
Total operating expenses |
|
32,035 |
|
|
|
36,302 |
|
|
|
115,917 |
|
|
|
164,443 |
|
Income (loss) from operations |
|
12,143 |
|
|
|
(35,273 |
) |
|
|
(63,759 |
) |
|
|
(154,346 |
) |
Interest expense |
|
(991 |
) |
|
|
(984 |
) |
|
|
(3,400 |
) |
|
|
(4,502 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(832 |
) |
|
|
— |
|
|
|
(1,673 |
) |
|
|
— |
|
Other income, net |
|
375 |
|
|
|
23 |
|
|
|
1,633 |
|
|
|
687 |
|
Income (loss) before
provision for income taxes |
|
10,695 |
|
|
|
(36,234 |
) |
|
|
(67,199 |
) |
|
|
(158,161 |
) |
Provision for income
taxes |
|
— |
|
|
|
— |
|
|
|
8 |
|
|
|
4 |
|
Net income (loss) |
$ |
10,695 |
|
|
$ |
(36,234 |
) |
|
$ |
(67,207 |
) |
|
$ |
(158,165 |
) |
Net income (loss) per share - basic and
diluted |
$ |
0.06 |
|
|
$ |
(0.31 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.52 |
) |
Shares used in
computing net income (loss) per share - basic |
|
192,430,121 |
|
|
|
115,260,610 |
|
|
|
158,690,083 |
|
|
|
104,205,645 |
|
Shares used in
computing net income (loss) per share - diluted |
|
193,840,751 |
|
|
|
115,260,610 |
|
|
|
158,690,083 |
|
|
|
104,205,645 |
|
Ardelyx (NASDAQ:ARDX)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Ardelyx (NASDAQ:ARDX)
Historical Stock Chart
Von Jul 2023 bis Jul 2024