Ardelyx Reports Second Quarter 2023 Financial Results and Provides 2023 IBSRELA Net Sales Revenue Guidance
Continued successful launch of IBSRELA, with Q2 net sales revenue of
XPHOZAH expected to launch in Q4, pending FDA approval
Company ends Q2 with
Conference call scheduled for
“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
Raab continued, “We also have commercial launch preparations underway ahead of the goal review date for XPHOZAH of
IBSRELA® (tenapanor) Update: Growth continues with
Revenue for Ardelyx’s first commercialized product, IBSRELA, continued a persistent growth pattern, with the company reporting IBSRELA net sales revenue of
XPHOZAH® (tenapanor) Update: New Drug Application (NDA) accepted; User fee goal date of
Other Corporate Developments
- In July, the company announced that an NDA for tenapanor had been accepted for review by China’s
Center for Drug Evaluationof the National Medical Products Administrationfor the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyxunder the terms of the license agreement between Ardelyxand its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.(Fosun Pharma). A potential approval of the NDA submission in Chinais expected by the end of 2024.
- The company had a significant presence at the 2023
Digestive Disease Week Conference(DDW 2023) in Chicago, Illfrom 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 Theatertitled: 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 LLCdeemed 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 millionof product supply and licensing related revenue compared to $1.0 millionin 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 2021action 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, 2023was $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.
Conference Call Details
The company will host a conference call today,
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.|
- 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.
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||$||30,058||$||96,140|
|Prepaid commercial manufacturing||13,166||13,567|
|Property and equipment, net||1,064||1,223|
|Prepaid and other assets||5,320||5,993|
|Liabilities and stockholders' equity|
|Accrued compensation and benefits||6,880||7,548|
|Current portion of operating lease liability||4,105||3,894|
|Current portion of long-term debt||27,052||26,711|
|Accrued expenses and other liabilities||12,571||12,380|
|Operating lease liability, net of current portion||3,752||5,855|
|Deferred royalty obligation related to the sale of future royalties||13,191||11,254|
|Total liabilities and stockholders' equity||$||211,203||$||190,066|
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended
|Condensed Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
||Six Months Ended
|Product sales, net||$||18,309||$||1,564||$||29,664||$||2,014|
|Product supply revenue||3,260||952||3,262||966|
|Cost of goods sold:|
|Cost of sales||492||44||864||57|
|Other cost of revenue||2,997||94||4,162||166|
|Total cost of goods sold||3,489||138||5,026||223|
|Research and development||8,282||9,741||17,375||18,592|
|Selling, general and administrative||27,186||18,862||53,989||38,201|
|Total operating expenses||35,468||28,603||71,364||56,793|
|Loss from operations||(16,624||)||(26,215||)||(42,688||)||(54,022||)|
|Non-cash interest expense related to the sale of future royalties||(968||)||(10||)||(1,937||)||(10||)|
|Other income, net||1,546||70||2,848||554|
|Loss before provision for income taxes||(17,121||)||(26,932||)||(43,880||)||(55,001||)|
|Provision for income taxes||—||6||14||8|
|Net loss per share of common stock - basic and diluted||$||(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|
Source: Ardelyx, Inc.