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, 2024 and provided a business update.
“In the second quarter, Ardelyx demonstrated our commitment to
our mission and to ensuring that patients remain at the forefront
of all of our efforts. We continued to drive expanded awareness and
use of our two first-in-class medicines that represent new
therapeutic options for patients who continue to have significant
unmet medical needs. In addition, importantly, we are standing with
the entire kidney community and fighting for patients whose health
is at risk,” said Mike Raab, president and chief executive officer
of Ardelyx.
Raab continued, “IBSRELA’s strong performance continued with
consistent quarter-over-quarter gains. This performance further
strengthens our conviction that IBSRELA is on track to achieve at
least ten percent market share and $1 billion in annual sales
before patent expiry. IBSRELA is providing meaningful clinical
benefits to patients at a time when the need among IBS-C patients
to address their symptoms remains significant. We believe IBSRELA
is well placed to address this unmet need and we continue to
invest, including the ongoing expansion of our sales team to
further our growth trajectory. XPHOZAH’s remarkable performance
continued, a clear indicator of the need for a novel therapy, like
XPHOZAH, to help patients achieve target phosphorus levels. This is
why it is so important that we take steps to protect patients
against the dire consequences of the access restrictions that will
occur if CMS moves oral-only phosphate lowering therapies into the
End-Stage Renal Disease Prospective Payment System.”
IBSRELA® (tenapanor)
records $35.4 million in net product sales revenue in Q2
2024U.S. net product sales revenue for IBSRELA during the
second quarter of 2024 was $35.4 million, showing approximately 25%
quarter-over-quarter growth compared to the first quarter of 2024,
and significant growth compared to the second quarter of 2023. The
strong performance reflects the meaningful demand for IBSRELA,
demonstrated by continued increases in new and refill prescriptions
as well as growth in new and repeat writing healthcare
providers.
Ardelyx continues to expect 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 $37.1 million net product sales revenue
during Q2 2024Ardelyx continued to see a strong response
to XPHOZAH from the nephrology community. U.S. net product sales
revenue during Q2 2024 was $37.1 million, demonstrating significant
quarter-over-quarter growth compared to the $15.2 million in net
product sales revenue reported during the first quarter of
2024.
During the quarter, the company announced that an analysis of
the Centers for Medicaid and Medicare Services (CMS) End-Stage
Renal Disease Prospective Payment System (ESRD PPS) proposed rule
to include oral-only medicines in the ESRD PPS revealed that the
policy and the manner in which CMS intends to implement it are
likely to cause significant restrictions on the use of XPHOZAH for
all patients, irrespective of insurance coverage, because it
interferes with the essential and appropriate shared
decision-making between healthcare professionals and their
patients. As part of an effort to protect patient access to
XPHOZAH, the company announced on July 2 that it has chosen
not to apply for the ESRD PPS Transitional Drug Add-on Payment
Adjustment; and on July 18, the company announced that it has filed
a lawsuit against CMS in partnership with the American Association
of Kidney Patients and the National Minority Quality Forum claiming
that CMS has violated its statutory and regulatory authority in its
determination to include oral-only phosphate lowering therapies in
the ESRD PPS.
Other Corporate Developments
- In June, the company presented data detailing educational needs
related to irritable bowel syndrome with constipation (IBS-C)
across healthcare disciplines in a poster at the 2024 American
Association of Nurse Practitioners National Conference.
- The company had a significant presence at the 2024 Digestive
Disease Week Conference, held May 18-21, 2024. The company
presented two posters providing additional data supporting IBSRELA.
The company also sponsored a Product Theater titled: “Discover
IBSRELA: a Different Mechanism of Action to Treat Adults With
IBS-C: A Case-Based Discussion,” where Brooks Cash, MD, led an
engaging discussion about important clinical considerations for
managing IBS-C in adult patients.
- The company had a significant presence at the National Kidney
Foundation 2024 Spring Clinical Meetings, held May 14-18, 2024. The
company presented three posters providing additional data
supporting XPHOZAH. The company also sponsored an Exhibitor
Spotlight titled “A New Paradigm: Rethinking Hyperphosphatemia
Management,” where David M. Spiegel, MD and Lisa Gutekunst MSEd,
RD, CSR, CDN, FNKF, discussed the clinical application of XPHOZAH
as add-on therapy for the many dialysis patients on a phosphate
binder with serum phosphorus levels above guideline-established
targets.
Second Quarter 2024 Financial Results
- Cash Position: As of June 30, 2024, the company had total cash,
cash equivalents and short-term investments of $186.0 million,
as compared to total cash, cash equivalents and short-term
investments of $184.3 million as of December 31, 2023.
- Revenues: Total revenue for the quarter ended June 30, 2024 was
$73.2 million, compared to $22.3 million in total revenue
during the quarter ended June 30, 2023, primarily reflecting
increased net product sales.
- IBSRELA U.S. net product sales revenue was $35.4 million,
compared to $18.3 million during the same period of 2023.
- XPHOZAH U.S. net product sales revenue was $37.1 million,
with no comparable revenue during the same period of 2023.
- There was no material product supply revenue during the quarter
ended June 30, 2024, compared to $3.3 million during the same
period of 2023.
- Licensing revenue was $19 thousand, compared to $764 thousand
during the same period of 2023.
- Non-cash royalty revenue related to the sale of future
royalties was $0.6 million, with no comparable revenue during
the same period of 2023.
- R&D Expenses: Research and development expenses were
$12.8 million for the quarter ended June 30, 2024, compared to
$8.3 million for the quarter ended June 30, 2023.
- SG&A Expenses: Selling, general and administrative expenses
were $64.7 million for the quarter ended June 30, 2024, an
increase of $37.5 million compared to $27.2 million for
the quarter ended June 30, 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 June 30, 2024 was
$16.5 million, or $(0.07) per share, compared to net loss of
$17.1 million, or $(0.08) per share, for the quarter ended
June 30, 2023. The $16.5 million net loss for the second quarter of
2024 included share-based compensation expense of
$10.8 million and non-cash interest expense related to the
sale of future royalties of $1.6 million.
Conference Call DetailsThe company will host a
conference call today, August 1, 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). 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 regarding opportunities for continued IBSRELA and
XPHOZAH adoption; the potential market share for IBSRELA and annual
U.S. net product sales revenue prior to patent expiry; projected
U.S. net product sales revenue for IBSRELA for full year 2024; the
impact of the Transitional Drug Add-on Payment Adjustment (TDAPA)
period and the ESRD PPS policy on access to XPHOZAH; and Ardelyx’s
current belief that not applying for TDAPA may help to protect
patient access to XPHOZAH. 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 1, 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) |
|
|
June 30, 2024 |
|
December 31, 2023 |
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
41,890 |
|
|
$ |
21,470 |
|
Investments |
|
144,071 |
|
|
|
162,829 |
|
Accounts receivable |
|
37,241 |
|
|
|
22,031 |
|
Prepaid commercial manufacturing |
|
14,797 |
|
|
|
18,925 |
|
Prepaid commercial manufacturing, non-current |
|
— |
|
|
|
4,235 |
|
Inventory, current |
|
13,756 |
|
|
|
12,448 |
|
Inventory, non-current |
|
69,676 |
|
|
|
37,039 |
|
Property and equipment, net |
|
1,016 |
|
|
|
1,009 |
|
Right-of-use assets |
|
4,324 |
|
|
|
5,589 |
|
Prepaid and other assets |
|
16,717 |
|
|
|
12,004 |
|
Total assets |
$ |
343,488 |
|
|
$ |
297,579 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Accounts payable |
$ |
10,881 |
|
|
$ |
11,138 |
|
Accrued compensation and benefits |
|
10,458 |
|
|
|
12,597 |
|
Current portion of operating lease liability |
|
3,550 |
|
|
|
4,435 |
|
Deferred revenue |
|
20,442 |
|
|
|
15,826 |
|
Accrued expenses and other liabilities |
|
26,718 |
|
|
|
15,041 |
|
Operating lease liability, net of current portion |
|
1,096 |
|
|
|
1,725 |
|
Long-term debt |
|
100,249 |
|
|
|
49,822 |
|
Deferred royalty obligation related to the sale of future
royalties |
|
23,104 |
|
|
|
20,179 |
|
Stockholders' equity |
|
146,990 |
|
|
|
166,816 |
|
Total liabilities and stockholders' equity |
$ |
343,488 |
|
|
$ |
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 June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net: |
|
|
|
|
|
|
|
IBSRELA |
$ |
35,445 |
|
|
$ |
18,309 |
|
|
$ |
63,806 |
|
|
$ |
29,664 |
|
XPHOZAH |
|
37,146 |
|
|
|
— |
|
|
|
52,297 |
|
|
|
— |
|
Total product sales, net |
|
72,591 |
|
|
|
18,309 |
|
|
|
116,103 |
|
|
|
29,664 |
|
Product supply revenue |
|
13 |
|
|
|
3,260 |
|
|
|
2,139 |
|
|
|
3,262 |
|
Licensing revenue |
|
19 |
|
|
|
764 |
|
|
|
36 |
|
|
|
776 |
|
Non-cash royalty revenue related to the sale of future
royalties |
|
599 |
|
|
|
— |
|
|
|
967 |
|
|
|
— |
|
Total revenues |
|
73,222 |
|
|
|
22,333 |
|
|
|
119,245 |
|
|
|
33,702 |
|
Cost of goods
sold: |
|
|
|
|
|
|
|
Cost of product sales |
|
1,405 |
|
|
|
492 |
|
|
|
2,418 |
|
|
|
864 |
|
Other cost of revenue |
|
8,031 |
|
|
|
2,997 |
|
|
|
14,146 |
|
|
|
4,162 |
|
Total cost of goods sold |
|
9,436 |
|
|
|
3,489 |
|
|
|
16,564 |
|
|
|
5,026 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
12,762 |
|
|
|
8,282 |
|
|
|
23,341 |
|
|
|
17,375 |
|
Selling, general and administrative |
|
64,654 |
|
|
|
27,186 |
|
|
|
117,648 |
|
|
|
53,989 |
|
Total operating expenses |
|
77,416 |
|
|
|
35,468 |
|
|
|
140,989 |
|
|
|
71,364 |
|
Loss from operations |
|
(13,630 |
) |
|
|
(16,624 |
) |
|
|
(38,308 |
) |
|
|
(42,688 |
) |
Interest expense |
|
(3,326 |
) |
|
|
(1,075 |
) |
|
|
(5,682 |
) |
|
|
(2,103 |
) |
Non-cash interest expense related to the sale of future
royalties |
|
(1,576 |
) |
|
|
(968 |
) |
|
|
(3,278 |
) |
|
|
(1,937 |
) |
Other income, net |
|
2,145 |
|
|
|
1,546 |
|
|
|
4,484 |
|
|
|
2,848 |
|
Loss before provision
for income taxes |
|
(16,387 |
) |
|
|
(17,121 |
) |
|
|
(42,784 |
) |
|
|
(43,880 |
) |
Provision for income
taxes |
|
67 |
|
|
|
— |
|
|
|
188 |
|
|
|
14 |
|
Net loss |
$ |
(16,454 |
) |
|
$ |
(17,121 |
) |
|
$ |
(42,972 |
) |
|
$ |
(43,894 |
) |
Net loss per share of
common stock - basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.21 |
) |
Shares used in
computing net loss per share - basic and diluted |
|
234,571,192 |
|
|
|
214,951,127 |
|
|
|
233,818,576 |
|
|
|
211,009,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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