Ardelyx Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Continued successful launch of IBSRELA, ending FY 2022 with
Resubmission of XPHOZAH New Drug Application expected in early Q2 2023
Company ends Q4 with approximately
Conference call scheduled for
“2022 was a remarkable year for
Recent Business Highlights
IBSRELA® (tenapanor) finishes 2022 with
XPHOZAH® (tenapanor) prepares for New Drug Application (NDA) resubmission in early Q2 2023
The resubmission of the NDA follows two significant developments for XPHOZAH that happened in the fourth quarter of 2022, providing a path to bring XPHOZAH to patients following a prolonged appeal process to the Complete Response Letter the company received in
Other Corporate Developments
- In February, the company released its first Environmental, Social and Governance (ESG) report, demonstrating the company’s commitment and progress towards initiatives and best practices that build a more equitable and sustainable society. The report is available on the company’s website.
- In February, the company reported that it had amended the debt financing agreement with SLR Investment Corp. it entered into in
February 2022. The senior term loan facility’s March 1, 2027maturity date is unchanged; however, the interest only period for the $27.5 millionthat was drawn at the February 2022closing may be extended by one year to March 31, 2025if certain product revenue targets are achieved for the year ended 2023 or the company has received approval by the FDA for the NDA for XPHOZAH on or before November 30, 2023. In addition, the deadline to borrow an additional $22.5 millionavailable under the facility has been extended to December 20, 2023, provided that the company has received approval by the FDA for the NDA for XPHOZAH on or before November 30, 2023and that the company has achieved certain product revenue targets.
Full Year 2022 Financial Results
- Cash Position: As of
December 31, 2022, the company had total cash, cash equivalents and short-term investments of $123.9 million, as compared to total cash, cash equivalents and short-term investments of $116.7 million as of December 31, 2021. As of February 28, 2023, the company had an unaudited cash, cash equivalents and short-term investments balance of $121.0 million, which included gross proceeds of $20.0 millionfor the sale of 7.7 million shares of the company’s common stock which were sold at a weighted average sales price of approximately $2.60per share during the period January 1, 2023to January 12, 2023under the company’s sales agreement with Jefferies LLC, dated August 13, 2021, deemed to be “at-the-market offerings.”
- Product Sales: Net product sales for IBSRELA were
$15.6 million during the year ended December 31, 2022.
- Collaboration Revenue: The company generated
$36.6 million in collaboration revenue for the year ended December 31, 2022, as compared to $10.1 million for the year ended December 31, 2021. The increase in collaboration revenue was primarily the result of $35.0 millionin milestone payments and payments under the 2022 amendment to the license agreement between Ardelyxand Kyowa Kirin Co, Ltd. (Kyowa Kirin), Ardelyx’s collaboration partner in Japan, earned upon Kyowa Kirin's submission of a New Drug Application to the Japanese Ministry of Health, Labour and Welfarefor tenapanor for the improvement of hyperphosphatemia in adult patients with CKD on dialysis. The company also realized increased product supply revenue in connection with its obligation to supply drug substance to Kyowa Kirin under its license agreement with Kyowa Kirin. Partially offsetting these increases was the full recognition through the end of 2021 of upfront payments associated with the Research Collaboration Agreement entered into with Kyowa Kirin.
- R&D Expenses: Research and development expenses were
$35.2 million for the year ended December 31, 2022, a decrease of $55.9 million compared to $91.1 million for the year ended December 31, 2021. Research and development expenses included non-cash stock compensation expense of approximately $3.2 million and $4.1 million in the years ended December 31, 2022, and December 31, 2021, respectively. The decrease in R&D expenses is primarily due to lower clinical study costs as a result of the completion of the OPTIMIZE study, lower tenapanor manufacturing expenses due to the company’s capitalization of costs associated with the production of IBSRELA to inventory, and lower expenses for research following the reduction in the research function in the fourth quarter of 2021.
- SG&A Expenses: Selling, general and administrative expenses were
$76.6 million for the year ended December 31, 2022, an increase of $4.3 million compared to $72.3 million for the year ended December 31, 2021. Selling, general and administrative expenses included non-cash stock compensation expense of approximately $7.5 million and $7.9 million in the years ended December 31, 2022, and December 31, 2021, respectively. The increase in selling, general and administrative expenses was primarily due to increased costs associated with the ongoing commercial launch of IBSRELA during 2022.
- Net Loss: Net loss for the year ended
December 31, 2022was $67.2 million, or $(0.42)per share, compared to net loss of $158.2 million, or $(1.52)per share, for the year ended December 31, 2021.
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||$||96,140||$||72,428|
|Prepaid commercial manufacturing||13,567||9,406|
|Property and equipment, net||1,223||2,362|
|Prepaid and other assets||5,993||8,202|
|Liabilities and stockholders' equity|
|Accrued compensation and benefits||7,548||5,422|
|Current portion of operating lease liability||3,894||3,492|
|Current portion of long-term debt||26,711||32,264|
|Accrued expenses and other liabilities||12,380||7,366|
|Operating lease liability, net of current portion||5,855||9,748|
|Deferred royalty obligation related to the sale of future royalties||11,254||—|
|Total liabilities and stockholders' equity||$||190,066||$||149,913|
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended
Condensed Statements of Operations
(In thousands, except share and per share amounts)
|Three Months Ended
||Twelve Months Ended
|Product sales, net||$||8,701||$||—||$||15,600||$||—|
|Product supply revenue||469||496||1,527||907|
|Collaborative development revenue||—||527||—||4,177|
|Cost of revenue||3,162||—||4,117||1,000|
|Research and development||9,142||20,968||35,201||91,140|
|Selling, general and administrative||19,731||15,334||76,599||72,303|
|Total operating expenses||32,035||36,302||115,917||164,443|
|Income (loss) from operations||12,143||(35,273||)||(63,759||)||(154,346||)|
|Non-cash interest expense related to the sale of future royalties||(832||)||—||(1,673||)||—|
|Other income, net||375||23||1,633||687|
|Income (loss) before provision for income taxes||10,695||(36,234||)||(67,199||)||(158,161||)|
|Provision for income taxes||—||—||8||4|
|Net income (loss)||$||10,695||$||(36,234||)||$||(67,207||)||$||(158,165||)|
|Net income (loss) per share - basic and diluted||$||0.06||$||(0.31||)||$||(0.42||)||$||(1.52||)|
|Shares used in computing net income (loss) per share - basic||192,430,121||115,260,610||158,690,083||104,205,645|
|Shares used in computing net income (loss) per share - diluted||193,840,751||115,260,610||158,690,083||104,205,645|
Source: Ardelyx, Inc.