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 third quarter ended
September 30, 2023 and provided a business update.
“Ardelyx is effectively advancing on all fronts with clear
focus, evidenced by the continued strong performance of IBSRELA as
well as the approval and commercial launch of XPHOZAH,” said Mike
Raab, president and chief executive officer. “Demonstrating
consistent, quarter-over-quarter growth of IBSRELA prescriptions
during the third quarter, we achieved a 22 percent increase in net
sales revenue. We continue to see an increase in new and repeat
writers, as well as new and refill prescriptions increasing from
established writers at a steady, meaningful trajectory. We have
raised our full year U.S. net sales revenue guidance for IBSRELA,
reflecting the important benefit this product is offering to
patients. In addition, on October 17, we received our long sought
after FDA approval of XPHOZAH. Our team is in the field and launch
is underway. We anticipate having product in channel in early
November.”
IBSRELA® (tenapanor)
growth continued with $22.3 million
in U.S. net sales revenue in Q3
2023Revenue for Ardelyx’s first commercialized
product, IBSRELA, continued a persistent growth pattern. Driven by
increased demand for IBSRELA, the company reported net sales
revenue of $22.3 million in the third quarter, 22 percent
quarter-over-quarter growth compared to the second quarter of
2023.
XPHOZAH® (tenapanor)
received FDA approval on Oct. 17, 2023On October 17, 2023,
Ardelyx announced that the U.S. Food and Drug Administration (FDA)
approved XPHOZAH 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. Following
approval, the company began commercial launch activities as well as
final supply and distribution activities. The company currently
expects to have XPHOZAH available in early November.
Other Corporate Developments
- On October 17, the company announced that it amended its
February 2022 loan agreement with investment affiliates managed by
SLR Capital Partners (SLR). The amendment includes access to an
additional $50 million in committed debt financing, and at
Ardelyx’s election and subject to SLR credit approval, may be
further increased by an additional $50 million. The interest-only
period for existing and new tranches funded under the instrument
has been extended to December 31, 2026, following the company’s
decision to draw the second tranche of $22.5 million in
October.
- In September, the company announced that its collaboration
partner in Japan, Kyowa Kirin Co., Ltd. (Kyowa Kirin), received
approval from the Japanese Ministry of Health, Labour and Welfare
for the New Drug Application (NDA) for tenapanor for the
improvement of hyperphosphatemia in adult patients with CKD on
dialysis. As a result of the approval, in October, Ardelyx received
an aggregate of $30 million from Kyowa Kirin in milestone payments
and payments under the 2022 amendment to the license agreement
between Ardelyx and Kyowa Kirin, as well as a $5 million payment
under the terms of its agreement with HealthCare Royalty
Partners.
- In late-October, Ardelyx’s partner in China, Shanghai Fosun
Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma),
received approval from the Hong Kong Department of Health for the
marketing application for IBSRELA for the treatment of irritable
bowel syndrome (IBS-C) in adults. The company also earned a $3.0
milestone payment from Fosun Pharma following the U.S. FDA approval
of XPHOZAH, which is expected to be received in the fourth
quarter.
- Ardelyx announced the publication
of results from its T3MPO-3 long-term open-label safety trial of
IBSRELA for IBS-C in the Journal of Neurogastroenterology and
Motility (JNM). The paper, titled “Long-term safety of tenapanor in
patients with irritable bowel syndrome with constipation in the
T3MPO-3 study,” can be accessible at the online edition of the
publication here.
- Ardelyx presented two posters covering additional positive
clinical observations of IBSRELA at the 2023 North American Society
for Pediatric Gastroenterology, Hepatology and Nutrition Annual
Meeting, which took place in San Diego, California from October
4-7, 2023.
- The company had a significant presence at the 2023 Annual
Scientific Meeting for the American College of Gastroenterology
(ACG 2023) in Vancouver, Canada from October 20-25, 2023. The
company presented two posters and an oral presentation covering
additional positive observations of IBSRELA. One poster, “Tenapanor
Can Improve Abdominal Symptoms Independent of Changes in Bowel
Movement Frequency in Adult Patients with IBS-C” authored by Darren
Brenner, M.D., Anthony Lembo, M.D., Yang Yang, Ph.D. and David
Rosenbaum, Ph.D., received a President’s Award distinction for high
quality, novel, unique and interesting research. The company also
sponsored a Product Theater titled “Discover a Different Mechanism
of Action to Treat Adults with IBS-C: A Case Based Discussion,”
where Kavita Kongara, M.D. Director of Motility services at
Northside Hospital in Atlanta, Ga., and Kimberley Orleck, PA-C,
MPH, RD, director of APPs at the Atlanta Gastroenterology
Associates, United Digestive, led a discussion on important
clinical considerations in managing adult patients with IBS-C.
Third Quarter
2023 Financial Results
- Cash Position: As of September 30, 2023,
the company had total cash, cash equivalents and short-term
investments of $165.1 million, compared to total cash, cash
equivalents and short-term investments of $123.9 million as of
December 31, 2022. During the quarter ended September 30,
2023, the company received gross proceeds of $58.4 million for
the sale of 13.8 million shares of the company’s common stock under
the company’s sales agreement with Jefferies LLC deemed to be
“at-the-market offerings.” Subsequent to September 30, in October
2023, the company received $30.0 million from Kyowa Kirin, $5.0
million from Healthcare Royalty Partners and drew $22.5 million
from SLR Capital. The company also currently expects a $3 million
milestone payment from Fosun Pharma following the U.S. approval of
XPHOZAH. As of October 30, 2023, Ardelyx’s total cash, cash
equivalents and short-term investments was approximately $218.1
million (unaudited).
- Revenues: Total revenues for the quarter ended
September 30, 2023, were $56.4 million, compared to $5.0 million in
total revenues in the third quarter of 2022, reflecting increased
IBSRELA sales, product supply and licensing revenues. U.S. net
product sales for IBSRELA were $22.3 million, compared to $4.9
million during the same period of 2022. Licensing revenue was $32.0
million in the quarter, reflecting $30 million milestone and
license agreement amendment payments from Kyowa Kirin following the
approval of tenapanor for hyperphosphatemia in Japan, as well as a
$2.0 million milestone payment from Fosun Pharma following the
acceptance of the NDA for tenapanor for hyperphosphatemia in China.
Product supply revenue was $2.1 million, compared to product supply
revenue of $92,000 in the same quarter of 2022.
- R&D Expenses: Research and development
expenses were $8.6 million for the quarter ended September 30,
2023, compared to $7.5 million for the quarter ended September 30,
2022. R&D expenses increased over the prior year primarily as a
result clinical trial and pharmacovigilance activities related to
IBSRELA.
- SG&A Expenses: Selling, general and
administrative expenses were $32.7 million for the quarter ended
September 30, 2023, an increase of $14.0 million compared to $18.7
million for the quarter ended September 30, 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 the launch of
XPHOZAH.
- Net Income (Loss): Net income for the quarter
ended September 30, 2023 was $6.6 million, or $0.03 per
share, compared to net loss of $22.9 million, or $(0.14) per
share, for the quarter ended September 30, 2022.
Financial GuidanceArdelyx currently expects
full-year 2023 U.S. net product revenue for IBSRELA to be between
$76.0 and $78.0 million.
Conference Call DetailsThe company will host a
conference call today, October 31, 2023, at 8:00 AM ET to discuss
these results. 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)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, Ardelyx’s
current expectation of timing for the commercial launch of XPHOZAH;
the timing and receipt of the milestone payment from Fosun Pharma
that was earned upon the U.S. FDA approval of XPHOZAH; and
projected net product revenue for IBSRELA for full year 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
Kimia Keshtbod kkeshtbod@ardelyx.com
Ardelyx, Inc. |
Condensed Balance Sheets |
(In thousands) |
|
|
September 30, 2023 |
|
December 31, 2022 |
|
(Unaudited) |
|
(1) |
Assets |
|
|
|
Cash and cash equivalents |
$ |
33,767 |
|
$ |
96,140 |
|
Investments |
|
131,313 |
|
|
27,769 |
|
Accounts receivable |
|
43,263 |
|
|
7,733 |
|
Prepaid commercial manufacturing |
|
17,176 |
|
|
13,567 |
|
Inventory, current |
|
8,524 |
|
|
3,282 |
|
Inventory, non-current |
|
38,974 |
|
|
25,064 |
|
Property and equipment, net |
|
1,116 |
|
|
1,223 |
|
Right-of-use assets |
|
6,523 |
|
|
9,295 |
|
Prepaid and other assets |
|
8,723 |
|
|
5,993 |
|
Total assets |
$ |
289,379 |
|
$ |
190,066 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Accounts payable |
$ |
7,736 |
|
$ |
10,859 |
|
Accrued compensation and benefits |
|
8,357 |
|
|
7,548 |
|
Current portion of operating lease liability |
|
4,321 |
|
|
3,894 |
|
Current portion of long-term debt |
|
— |
|
|
26,711 |
|
Deferred revenue |
|
14,362 |
|
|
13,236 |
|
Accrued expenses and other liabilities |
|
19,213 |
|
|
12,380 |
|
Operating lease liability, net of current portion |
|
2,887 |
|
|
5,855 |
|
Long-term debt, net of current portion |
|
27,229 |
|
|
— |
|
Deferred royalty obligation related to the sale of future
royalties |
|
14,113 |
|
|
11,254 |
|
Stockholders' equity |
|
191,161 |
|
|
98,329 |
|
Total liabilities and stockholders' equity |
$ |
289,379 |
|
$ |
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 September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
22,285 |
|
|
$ |
4,885 |
|
|
$ |
51,949 |
|
|
$ |
6,899 |
|
Product supply revenue |
|
2,092 |
|
|
|
92 |
|
|
|
5,354 |
|
|
|
1,058 |
|
Licensing revenue |
|
32,014 |
|
|
|
9 |
|
|
|
32,790 |
|
|
|
23 |
|
Total revenues |
|
56,391 |
|
|
|
4,986 |
|
|
|
90,093 |
|
|
|
7,980 |
|
Cost of goods
sold: |
|
|
|
|
|
|
|
Cost of sales |
|
644 |
|
|
|
230 |
|
|
|
1,508 |
|
|
|
287 |
|
Other cost of revenue |
|
7,048 |
|
|
|
502 |
|
|
|
11,210 |
|
|
|
668 |
|
Total cost of goods sold |
|
7,692 |
|
|
|
732 |
|
|
|
12,718 |
|
|
|
955 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,637 |
|
|
|
7,467 |
|
|
|
26,012 |
|
|
|
26,059 |
|
Selling, general and administrative |
|
32,664 |
|
|
|
18,667 |
|
|
|
86,653 |
|
|
|
56,868 |
|
Total operating expenses |
|
41,301 |
|
|
|
26,134 |
|
|
|
112,665 |
|
|
|
82,927 |
|
Income (loss) from operations |
|
7,398 |
|
|
|
(21,880 |
) |
|
|
(35,290 |
) |
|
|
(75,902 |
) |
Interest expense |
|
(1,107 |
) |
|
|
(886 |
) |
|
|
(3,210 |
) |
|
|
(2,409 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(922 |
) |
|
|
(831 |
) |
|
|
(2,859 |
) |
|
|
(841 |
) |
Other income, net |
|
1,460 |
|
|
|
704 |
|
|
|
4,308 |
|
|
|
1,258 |
|
Income (loss) before
provision for income taxes |
|
6,829 |
|
|
|
(22,893 |
) |
|
|
(37,051 |
) |
|
|
(77,894 |
) |
Provision for income
taxes |
|
200 |
|
|
|
— |
|
|
|
214 |
|
|
|
8 |
|
Net income
(loss) |
$ |
6,629 |
|
|
$ |
(22,893 |
) |
|
$ |
(37,265 |
) |
|
$ |
(77,902 |
) |
Net income (loss) per
share of common stock - basic and diluted |
$ |
0.03 |
|
|
$ |
(0.14 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.53 |
) |
Shares used in
computing net income (loss) per share - basic |
|
222,782,229 |
|
|
|
165,104,789 |
|
|
|
214,976,555 |
|
|
|
147,319,818 |
|
Shares used in
computing net income (loss) per share - diluted |
|
227,894,335 |
|
|
|
165,104,789 |
|
|
|
214,976,555 |
|
|
|
147,319,818 |
|
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