Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance
Continued successful launch of IBSRELA, with Q3 net sales revenue of
XPHOZAH® launch underway following
Company ends Q3 with
Conference call scheduled for
“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
IBSRELA® (tenapanor) growth continued with
Revenue 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
XPHOZAH® (tenapanor) received FDA approval on
Other Corporate Developments
October 17, the company announced that it amended its February 2022loan agreement with investment affiliates managed by SLR Capital Partners(SLR). The amendment includes access to an additional $50 millionin 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 millionin 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 Welfarefor 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, Ardelyxreceived an aggregate of $30 millionfrom Kyowa Kirin in milestone payments and payments under the 2022 amendment to the license agreement between Ardelyxand Kyowa Kirin, as well as a $5 millionpayment 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 Healthfor the marketing application for IBSRELA for the treatment of irritable bowel syndrome (IBS-C) in adults. The company also earned a $3.0milestone payment from Fosun Pharma following the U.S.FDA approval of XPHOZAH, which is expected to be received in the fourth quarter. Ardelyxannounced 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. Ardelyxpresented 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, Californiafrom 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, Canadafrom 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 Theatertitled “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 Hospitalin 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 LLCdeemed to be “at-the-market offerings.” Subsequent to September 30, in October 2023, the company received $30.0 millionfrom Kyowa Kirin, $5.0 millionfrom Healthcare Royalty Partnersand drew $22.5 millionfrom SLR Capital. The company also currently expects a $3 millionmilestone 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 millionin 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 millionduring the same period of 2022. Licensing revenue was $32.0 millionin the quarter, reflecting $30 millionmilestone and license agreement amendment payments from Kyowa Kirin following the approval of tenapanor for hyperphosphatemia in Japan, as well as a $2.0 millionmilestone 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 $92,000in the same quarter of 2022.
- R&D Expenses: Research and development expenses were
$8.6 millionfor the quarter ended September 30, 2023, compared to $7.5 millionfor 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 millionfor the quarter ended September 30, 2023, an increase of $14.0 millioncompared to $18.7 millionfor 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, 2023was $6.6 million, or $0.03per share, compared to net loss of $22.9 million, or $(0.14)per share, for the quarter ended September 30, 2022.
Conference Call Details
The 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.
- 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 PRECAUTIONS
Risk 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 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%).
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)
XPHOZAH is contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
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.
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.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Investor and Media Contacts:
|Condensed Balance Sheets|
|Cash and cash equivalents||$||33,767||$||96,140|
|Prepaid commercial manufacturing||17,176||13,567|
|Property and equipment, net||1,116||1,223|
|Prepaid and other assets||8,723||5,993|
|Liabilities and stockholders' equity|
|Accrued compensation and benefits||8,357||7,548|
|Current portion of operating lease liability||4,321||3,894|
|Current portion of long-term debt||—||26,711|
|Accrued expenses and other liabilities||19,213||12,380|
|Operating lease liability, net of current portion||2,887||5,855|
|Long-term debt, net of current portion||27,229||—|
|Deferred royalty obligation related to the sale of future royalties||14,113||11,254|
|Total liabilities and stockholders' equity||$||289,379||$||190,066|
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended
|Condensed Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
||Nine Months Ended
|Product sales, net||$||22,285||$||4,885||$||51,949||$||6,899|
|Product supply revenue||2,092||92||5,354||1,058|
|Cost of goods sold:|
|Cost of sales||644||230||1,508||287|
|Other cost of revenue||7,048||502||11,210||668|
|Total cost of goods sold||7,692||732||12,718||955|
|Research and development||8,637||7,467||26,012||26,059|
|Selling, general and administrative||32,664||18,667||86,653||56,868|
|Total operating expenses||41,301||26,134||112,665||82,927|
|Income (loss) from operations||7,398||(21,880||)||(35,290||)||(75,902||)|
|Non-cash interest expense related to the sale of future royalties||(922||)||(831||)||(2,859||)||(841||)|
|Other income, net||1,460||704||4,308||1,258|
|Income (loss) before provision for income taxes||6,829||(22,893||)||(37,051||)||(77,894||)|
|Provision for income taxes||200||—||214||8|
|Net income (loss)||$||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|
Source: Ardelyx, Inc.