Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update
ARDX 10.31.2024
Drug:tenapanor IBSRELA
Drug:tenapanor XPHOZAH
Diseases:Irritable Bowel Syndrome with Constipation
Diseases:Hyperphosphatemia in Chronic Kidney Disease
Date of Upcoming Event:2024-10-25
Name of Upcoming Event:2024 Annual Scientific Meeting for the American College of Gastroenterology (ACG 2024)
Date of Upcoming Event:2024-10-23
Name of Upcoming Event:2024 Annual American Society of Nephrology Kidney Week
IBSRELA generates
XPHOZAH generates
Company ends Q3 with approximately$190 millionin cash, cash equivalents and investments
Conference call scheduled for
“The continued strong performance of
IBSRELA® (tenapanor) records
XPHOZAH®(tenapanor) launch progresses, records
Other Corporate Developments
- Today, the company announced that it amended its
February 2022 loan agreement with investment affiliates managed bySLR Capital Partners (SLR). The company drew$50 million at SOFR plus 4.02% inOctober 2024 , added the opportunity to draw an additional$50 million at the same interest rate, and extended the interest-only period for existing and new tranches funded under the instrument toJuly 1, 2028 . - The company had a significant presence at the 2024 Annual Scientific Meeting for the
American College of Gastroenterology (ACG 2024) inPhiladelphia fromOctober 25-30, 2024 . The company presented two posters featuring data from the 2024 IBS in America supplemental survey, sponsored by the company in collaboration withHealth Union , which was conducted to better understand the symptoms and impact of IBS-C on the overall health and quality of life among patients. - The company had a significant presence at the 2024 Annual
American Society of Nephrology Kidney Week inSan Diego fromOctober 23-27, 2024 . The company presented two posters covering additional data for XPHOZAH. - In October, the company announced the publication of a review article exploring the patient burden and therapeutic landscape of IBS-C in the
U.S. inClinical and Experimental Gastroenterology.The article is available online and can be foundhere. - In August, the company announced the appointment of experienced biopharma executive,
Eric Foster , as Chief Commercial Officer. - In July, the company announced the publication of two plain language summaries from XPHOZAH clinical trials in
Current Medical Research and Opinion.
Third Quarter2024Financial Results
- Cash Position: As of
September 30, 2024 , the company had total cash, cash equivalents and short-term investments of$190 .4 million, as compared to total cash, cash equivalents and short-term investments of$184 .3 million as ofDecember 31, 2023 . In October, the company drew$49 .7 million in net proceeds under its term loan with SLR Investment Corp. - Revenue: Total revenue for the quarter ended
September 30, 2024 was$98.2 million , compared to$56 .4 million in total revenue during the quarter endedSeptember 30, 2023 , driven by increases in net product sales.- IBSRELA
U.S. net product sales revenue was$40 .6 million, compared to$22 .3 million during the same period of 2023. - XPHOZAH
U.S. net product sales revenue was$51 .5 million, with no comparable revenue during the same period of 2023. - Product supply revenue was
$5 .3 million, compared to$2 .1 million during the same period of 2023. - Licensing revenue was $20 thousand, compared to $32 million during the same period of 2023 related to
$30 million milestone and license agreement amendment payments from Kyowa Kirin following the approval of tenapanor for hyperphosphatemia inJapan , as well as a$2.0 million milestone payment from Fosun Pharma following the acceptance of the NDA for tenapanor for hyperphosphatemia inChina . - Non-cash royalty revenue related to the sale of future royalties was
$0 .8 million, with no comparable revenue during the same period of 2023.
- IBSRELA
- R&D Expenses: Research and development expenses were
$15 .3 million for the quarter endedSeptember 30, 2024 , compared to$8 .6 million for the quarter endedSeptember 30, 2023 , primarily related to increased medical engagement with the scientific communities in the areas of gastroenterology and nephrology and pediatric clinical trials. - SG&A Expenses: Selling, general and administrative expenses were
$65 .0 million for the quarter endedSeptember 30, 2024 , an increase of$32 .3 million compared to$32 .7 million for the quarter endedSeptember 30, 2023 . The increase in selling, general and administrative expenses was related to increased costs associated with the ongoing commercialization of IBSRELA and XPHOZAH, primarily the expansion of the IBSRELA field-based team which was completed during the third quarter of 2024. - Net Loss: Net loss for the quarter ended
September 30, 2024 was$0 .8 million, or$(0.00) per share, compared to net income of$6 .6 million, or$0.03 per share, for the quarter endedSeptember 30, 2023 . The$0 .8 million net loss for the third quarter of 2024 included share-based compensation expense of$9 .1 million and non-cash interest expense related to the sale of future royalties of$1 .9 million.
Conference Call DetailsThe company will host a conference call today,
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.
DiarrheaDiarrhea 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 REACTIONSThe 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%).
INDICATIONIBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Please see fullPrescribing 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 PRECAUTIONSDiarrheaPatients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONSDiarrhea, 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.
INDICATIONXPHOZAH (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 fullPrescribing Information.
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Forward Looking StatementsTo the extent that statements contained in this press release are not descriptions of historical facts regarding
Investor and Media Contacts:
| Ardelyx, Inc.Condensed Balance Sheets(In thousands) | ||||||
| (Unaudited) | (1) | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 47,429 | $ | 21,470 | ||
| Investments | 142,973 | 162,829 | ||||
| Accounts receivable | 53,195 | 22,031 | ||||
| Prepaid commercial manufacturing | 16,663 | 18,925 | ||||
| Prepaid commercial manufacturing, non-current | — | 4,235 | ||||
| Inventory, current | 11,378 | 12,448 | ||||
| Inventory, non-current | 73,780 | 37,039 | ||||
| Property and equipment, net | 1,028 | 1,009 | ||||
| Right-of-use assets | 3,625 | 5,589 | ||||
| Prepaid and other assets | 17,792 | 12,004 | ||||
| Total assets | $ | 367,863 | $ | 297,579 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable | $ | 15,824 | $ | 11,138 | ||
| Accrued compensation and benefits | 11,541 | 12,597 | ||||
| Current portion of operating lease liability | 2,567 | 4,435 | ||||
| Deferred revenue | 20,042 | 15,826 | ||||
| Accrued expenses and other liabilities | 33,295 | 15,041 | ||||
| Operating lease liability, net of current portion | 1,218 | 1,725 | ||||
| Long-term debt | 100,707 | 49,822 | ||||
| Deferred royalty obligation related to the sale of future royalties | 24,372 | 20,179 | ||||
| Stockholders' equity | 158,297 | 166,816 | ||||
| Total liabilities and stockholders' equity | $ | 367,863 | $ | 297,579 | ||
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended
| Ardelyx, Inc.Condensed Statements of Operations(Unaudited)(In thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues: | |||||||||||||||
| Product sales, net: | |||||||||||||||
| IBSRELA | $ | 40,638 | $ | 22,285 | $ | 104,444 | $ | 51,949 | |||||||
| XPHOZAH | 51,452 | — | 103,749 | — | |||||||||||
| Total product sales, net | 92,090 | 22,285 | 208,193 | 51,949 | |||||||||||
| Product supply revenue | 5,322 | 2,092 | 7,461 | 5,354 | |||||||||||
| Licensing revenue | 20 | 32,014 | 56 | 32,790 | |||||||||||
| Non-cash royalty revenue related to the sale of future royalties | 809 | — | 1,776 | — | |||||||||||
| Total revenues | 98,241 | 56,391 | 217,486 | 90,093 | |||||||||||
| Cost of goods sold: | |||||||||||||||
| Cost of product sales | 1,715 | 644 | 4,133 | 1,508 | |||||||||||
| Other cost of revenue | 14,013 | 7,048 | 28,159 | 11,210 | |||||||||||
| Total cost of goods sold | 15,728 | 7,692 | 32,292 | 12,718 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 15,310 | 8,637 | 38,651 | 26,012 | |||||||||||
| Selling, general and administrative | 64,970 | 32,664 | 182,618 | 86,653 | |||||||||||
| Total operating expenses | 80,280 | 41,301 | 221,269 | 112,665 | |||||||||||
| Income (loss) from operations | 2,233 | 7,398 | (36,075 | ) | (35,290 | ) | |||||||||
| Interest expense | (3,357 | ) | (1,107 | ) | (9,039 | ) | (3,210 | ) | |||||||
| Non-cash interest expense related to the sale of future royalties | (1,924 | ) | (922 | ) | (5,202 | ) | (2,859 | ) | |||||||
| Other income, net | 2,282 | 1,460 | 6,766 | 4,308 | |||||||||||
| Income (loss) before provision for income taxes | (766 | ) | 6,829 | (43,550 | ) | (37,051 | ) | ||||||||
| Provision for income taxes | 43 | 200 | 231 | 214 | |||||||||||
| Net income (loss) | $ | (809 | ) | $ | 6,629 | $ | (43,781 | ) | $ | (37,265 | ) | ||||
| Net income (loss) per share of common stock - basic and diluted | $ | (0.00 | ) | $ | 0.03 | $ | (0.19 | ) | $ | (0.17 | ) | ||||
| Shares used in computing net income (loss) per share - basic | 235,911,399 | 222,782,229 | 234,516,305 | 214,976,555 | |||||||||||
| Shares used in computing net (loss) income per share - diluted | 235,911,399 | 227,894,335 | 234,516,305 | 214,976,555 | |||||||||||
Source: Ardelyx, Inc.