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 second quarter ended
June 30, 2023 and provided a business update.
“Ardelyx continued the momentum we established during a historic
2022 through the first half of 2023 and we are poised to deliver on
our corporate priorities to drive IBSRELA growth and prepare for
the potential approval and launch of XPHOZAH in the fourth
quarter,” said Mike Raab, president and chief executive officer.
“IBSRELA is carving out an important role in treating IBS-C,
offering a meaningful new option for patients looking for a
different approach to manage their IBS-C. With 61%
quarter-over-quarter net sales revenue growth from Q1 to Q2 and
usage and awareness continuing to increase, we are establishing
IBSRELA as a meaningful therapeutic choice for patients and
building market acceptance among the prescribing community, both of
which are critical to our success. Now, with more than a year of
launch metrics to work with, we are pleased, for the first time, to
share that we expect IBSRELA net sales revenue to be between $72
and $77 million for the full year 2023. This guidance reflects
continued, meaningful growth and we believe demonstrates the
potential for this drug to generate $500 million or more of annual
peak net sales revenue.”
Raab continued, “We also have commercial launch preparations
underway ahead of the goal review date for XPHOZAH of October 17.
Pending FDA approval, we are looking forward to bringing this novel
therapy to patients in the fourth quarter of this year, delivering
on a promise to patients and the vision of Ardelyx for the second
time in two years.”
IBSRELA® (tenapanor)
Update: Growth continues with
$18.3 million in net sales revenue in
Q2 2023Revenue for
Ardelyx’s first commercialized product, IBSRELA, continued a
persistent growth pattern, with the company reporting IBSRELA net
sales revenue of $18.3 million, a 61% quarter-over-quarter
growth compared to $11.4 million of net sales revenue reported
in the first quarter of 2023. Launched in the U.S. in 2022 for the
treatment of irritable bowel syndrome with constipation (IBS-C) in
adults, IBSRELA has shown consistent growth across new and refill
prescriptions as well as new and repeat writing healthcare
providers. Spherix Global Insights, a premier market research firm
that publishes independent, syndicated monthly tracking research,
has included IBSRELA as one of the key gastrointestinal launches it
tracks. The May 2023 LaunchDynamix report published in Q2 by
Spherix reports significant increases in awareness and experience
with IBSRELA, while continuing to rate the product highly,
12-months post-launch. Among the 76 gastroenterologists (GIs)
surveyed in its market research in May 2023, 91% rate IBSRELA as
either a substantial or moderate advance over currently available
IBS-C therapies and among the surveyed GIs who reported using
IBSRELA, 98% report high or moderate satisfaction.
XPHOZAH® (tenapanor)
Update: New Drug Application (NDA) accepted; User fee goal date of
Oct. 17, 2023In May, Ardelyx announced that the U.S. Food
and Drug Administration (FDA) had accepted the resubmitted New Drug
Application (NDA) for XPHOZAH for the control of serum phosphorus
in adult patients with chronic kidney disease on dialysis who have
had an inadequate response or intolerance to a phosphate binder
therapy. The FDA granted XPHOZAH a class 2, six-month review with a
user fee goal date of October 17, 2023. The company is now
preparing to launch XPHOZAH in the fourth quarter of 2023, pending
FDA approval.
Other Corporate Developments
- In July, the company announced that an NDA for tenapanor had
been accepted for review by China’s Center for Drug Evaluation of
the National Medical Products Administration for the control of
serum phosphorus in adult patients with chronic kidney disease on
hemodialysis. This acceptance triggers a $2 million milestone
payment to Ardelyx under the terms of the license agreement between
Ardelyx and its collaboration partner in China, Shanghai Fosun
Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A
potential approval of the NDA submission in China is expected by
the end of 2024.
- The company had a significant presence at the 2023 Digestive
Disease Week Conference (DDW 2023) in Chicago, Ill from May 6-9.
The company presented a poster which included a post-hoc data
analysis from the Phase 3 T3MPO-2 study and sponsored a Product
Theater titled: Discover a Different Mechanism of Action to Treat
Adults with IBS-C: A Case Based Discussion where Darren Brenner,
M.D., Professor of Medicine and Surgery, Northwestern University
Feinberg School of Medicine, reviewed the multifactorial
pathophysiology of IBS-C, the novel mechanism of action of IBSRELA,
and efficacy and safety data of IBSRELA from the Phase 3 clinical
trial program.
Second Quarter
2023 Financial Results
- Cash Position: As of June 30, 2023, the
company had total cash, cash equivalents and short-term investments
of $127.6 million, as compared to total cash, cash equivalents
and short-term investments of $123.9 million as of
December 31, 2022. During the quarter ended June 30,
2023, the company received gross proceeds of $11.6 million for
the sale of 3.0 million shares of the company’s common stock under
the company’s sales agreement with Jefferies LLC deemed to be
“at-the-market offerings.”
- Revenues: Net product sales for IBSRELA were
$18.3 million during the quarter ended June 30, 2023,
compared to $1.6 million for the quarter ended June 30,
2022. Total revenues for the second quarter were $22.3 million,
which included $4.0 million of product supply and licensing related
revenue compared to $1.0 million in product supply and licensing
related revenue in the same period in 2022.
- R&D Expenses: Research and development
expenses were $8.3 million for the quarter ended June 30,
2023, compared to $9.7 million for the quarter ended
June 30, 2022. R&D expenses in the prior year included
higher tenapanor manufacturing expenses as well as regulatory
consulting expenses related to the appeal of the FDA’s July 2021
action on the NDA for XPHOZAH.
- SG&A Expenses: Selling, general and
administrative expenses were $27.2 million for the quarter
ended June 30, 2023, an increase of $8.3 million compared
to $18.9 million for the quarter ended June 30, 2022. The
increase in selling, general and administrative expenses was
primarily due to increased costs associated with the ongoing
commercial launch of IBSRELA.
- Net Loss: Net loss for the quarter ended
June 30, 2023 was $17.1 million, or $(0.08) per share,
compared to net loss of $26.9 million, or $(0.19) per share,
for the quarter ended June 30, 2022.
Financial GuidanceArdelyx currently expects
full-year 2023 net product revenue for IBSRELA to be between $72.0
and $77.0 million.
Conference Call DetailsThe company will host a
conference call today, August 2, 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
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 who have had an inadequate response or intolerance to
phosphate binder therapy, which has completed three successful
Phase 3 trials and an additional two Phase 4 open label 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 Ardelyx’s expectation
regarding opportunities for continued IBSRELA adoption, Ardelyx’s
current expectation of the user fee goal date for the NDA for
XPHOZAH and any subsequent commercial launch of XPHOZAH; the
projected net revenue for IBSRELA for full year 2023; the timing of
the review for the NDA for tenapanor for hyperphosphatemia in
China; and the potential role that tenapanor can play in offering a
new treatment option for patients with hyperphosphatemia. 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 August 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) |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(Unaudited) |
|
(1) |
Assets |
|
|
|
Cash and cash equivalents |
$ |
30,058 |
|
$ |
96,140 |
|
Investments |
|
97,521 |
|
|
27,769 |
|
Accounts receivable |
|
9,109 |
|
|
7,733 |
|
Prepaid commercial manufacturing |
|
13,166 |
|
|
13,567 |
|
Inventory, current |
|
7,617 |
|
|
3,282 |
|
Inventory, non-current |
|
40,295 |
|
|
25,064 |
|
Property and equipment, net |
|
1,064 |
|
|
1,223 |
|
Right-of-use assets |
|
7,053 |
|
|
9,295 |
|
Prepaid and other assets |
|
5,320 |
|
|
5,993 |
|
Total assets |
$ |
211,203 |
|
$ |
190,066 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Accounts payable |
$ |
5,294 |
|
$ |
10,859 |
|
Accrued compensation and benefits |
|
6,880 |
|
|
7,548 |
|
Current portion of operating lease liability |
|
4,105 |
|
|
3,894 |
|
Current portion of long-term debt |
|
27,052 |
|
|
26,711 |
|
Deferred revenue |
|
15,197 |
|
|
13,236 |
|
Accrued expenses and other liabilities |
|
12,571 |
|
|
12,380 |
|
Operating lease liability, net of current portion |
|
3,752 |
|
|
5,855 |
|
Deferred royalty obligation related to the sale of future
royalties |
|
13,191 |
|
|
11,254 |
|
Stockholders' equity |
|
123,161 |
|
|
98,329 |
|
Total liabilities and stockholders' equity |
$ |
211,203 |
|
$ |
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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
18,309 |
|
|
$ |
1,564 |
|
|
$ |
29,664 |
|
|
$ |
2,014 |
|
Product supply revenue |
|
3,260 |
|
|
|
952 |
|
|
|
3,262 |
|
|
|
966 |
|
Licensing revenue |
|
764 |
|
|
|
10 |
|
|
|
776 |
|
|
|
14 |
|
Total revenues |
|
22,333 |
|
|
|
2,526 |
|
|
|
33,702 |
|
|
|
2,994 |
|
Cost of goods
sold: |
|
|
|
|
|
|
|
Cost of sales |
|
492 |
|
|
|
44 |
|
|
|
864 |
|
|
|
57 |
|
Other cost of revenue |
|
2,997 |
|
|
|
94 |
|
|
|
4,162 |
|
|
|
166 |
|
Total cost of goods sold |
|
3,489 |
|
|
|
138 |
|
|
|
5,026 |
|
|
|
223 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,282 |
|
|
|
9,741 |
|
|
|
17,375 |
|
|
|
18,592 |
|
Selling, general and administrative |
|
27,186 |
|
|
|
18,862 |
|
|
|
53,989 |
|
|
|
38,201 |
|
Total operating expenses |
|
35,468 |
|
|
|
28,603 |
|
|
|
71,364 |
|
|
|
56,793 |
|
Loss from operations |
|
(16,624 |
) |
|
|
(26,215 |
) |
|
|
(42,688 |
) |
|
|
(54,022 |
) |
Interest expense |
|
(1,075 |
) |
|
|
(777 |
) |
|
|
(2,103 |
) |
|
|
(1,523 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(968 |
) |
|
|
(10 |
) |
|
|
(1,937 |
) |
|
|
(10 |
) |
Other income, net |
|
1,546 |
|
|
|
70 |
|
|
|
2,848 |
|
|
|
554 |
|
Loss before provision
for income taxes |
|
(17,121 |
) |
|
|
(26,932 |
) |
|
|
(43,880 |
) |
|
|
(55,001 |
) |
Provision for income
taxes |
|
— |
|
|
|
6 |
|
|
|
14 |
|
|
|
8 |
|
Net loss |
$ |
(17,121 |
) |
|
$ |
(26,938 |
) |
|
$ |
(43,894 |
) |
|
$ |
(55,009 |
) |
Net loss per share of
common stock - basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.40 |
) |
Shares used in
computing net loss per share - basic and diluted |
|
214,951,127 |
|
|
|
145,544,372 |
|
|
|
211,009,029 |
|
|
|
138,279,945 |
|
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