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Conference call scheduled for 4:30 p.m. Eastern Time today
WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ -- 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 business updates and financial results for the third quarter ended September 30, 2022.
"We are now a full six months into the launch of IBSRELA® and are extremely encouraged by the commercial progress we are making," said Mike Raab, president, and chief executive officer of Ardelyx. "Our efforts are reinforcing strong demand and market receptivity for our novel treatment option in the IBS-C market. We are in a unique position in the biopharmaceutical industry, demonstrating our status as an evolving, impressive growth story with many opportunities ahead. We look forward to continued commercial progress with IBSRELA and the upcoming FDA Advisory Committee meeting for XPHOZAH® on November 16, 2022."
Recent Business Highlights and Updates
Third Quarter 2022 Financial Results
Conference Call Details
The company will host a conference call today, November 3, 2022, at 4:30 p.m. ET to review its financial results and provide a business overview. To participate in the conference call, please dial (866) 374-5140 (domestic) or (404) 400-0571 (international) and enter the pin 79680409#. Live audio of the conference call will be simultaneously webcast and will be available under the Investors section of the company's website at www.ardelyx.com. The webcast will be archived and available for replay 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
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
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 to control serum phosphorus in adult patients with 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.
Forward Looking Statements
To 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 the potential commercial and other opportunities for the company, and Ardelyx's current expectation of the date of the Advisory Committee meeting to be convened to provide input regarding the clinical meaningfulness of the phosphate lowering effect observed in the Phase 3 clinical program for 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 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 3, 2022, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Ardelyx, Inc.
Condensed Balance Sheets
(In thousands)
September 30, 2022
December 31, 2021
(Unaudited)
(1)
Assets
Cash and cash equivalents
$ 61,628
$ 72,428
Investments
28,995
44,261
Accounts receivable
5,208
502
Inventory, current portion
1,250
—
Property and equipment, net
1,294
2,362
Right-of-use assets
10,182
12,752
Prepaid commercial manufacturing
16,145
9,406
Prepaid and other assets
19,970
8,202
Total assets
$ 144,672
$ 149,913
Liabilities and stockholders' equity
Accounts payable
$ 3,113
$ 4,277
Accrued compensation and benefits
7,165
5,422
Current portion of operating lease liability
3,791
3,492
Current portion of long-term debt
26,541
32,264
Deferred revenue
12,563
4,727
Accrued expenses and other liabilities
7,338
7,366
Operating lease liability, net of current portion
6,878
9,748
Deferred royalty obligation related to the sale of future royalties
10,422
—
Stockholders' equity
66,861
82,617
Total liabilities and stockholders' equity
$ 144,672
$ 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
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenues:
Product sales, net
$ 4,885
$ —
$ 6,899
$ —
Product supply revenue
92
285
1,058
411
Licensing revenue
9
2
23
5,007
Collaborative development revenue
—
886
—
3,650
Total revenues
4,986
1,173
7,980
9,068
Operating expenses:
Cost of revenue
732
—
955
1,000
Research and development
7,467
23,695
26,059
70,172
Selling, general and administrative
18,667
19,714
56,868
56,969
Total operating expenses
26,866
43,409
83,882
128,141
Loss from operations
(21,880)
(42,236)
(75,902)
(119,073)
Interest expense
(886)
(1,216)
(2,409)
(3,518)
Non-cash interest expense related to the sale of future royalties
(831)
—
(841)
—
Other income (expense), net
704
(134)
1,258
664
Loss before provision for income taxes
(22,893)
(43,586)
(77,894)
(121,927)
Provision for income taxes
—
1
8
4
Net loss
$ (22,893)
$ (43,587)
$ (77,902)
$ (121,931)
Net loss per common share, basic and diluted
$ (0.14)
$ (0.42)
$ (0.53)
$ (1.21)
Shares used in computing net loss per share - basic and diluted
165,104,789
104,144,606
147,319,818
100,480,156
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SOURCE Ardelyx