Ardelyx Announces $27.5 Million Debt Financing Agreement with SLR Capital Partners

- Non-dilutive capital extends cash runway to further support launch of IBSRELA® (tenapanor)

WALTHAM, Mass., Feb. 24, 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 announced that it has entered into a debt financing agreement with investment affiliates managed by SLR Capital Partners ("SLR"). 

"We are pleased to enter into this agreement with SLR for non-dilutive capital ahead of an important catalyst for the company this year, namely the launch and commercialization of IBSRELA for the treatment of irritable bowel syndrome with constipation in adults," said Justin Renz, chief financial officer of Ardelyx. "This financing further strengthens our balance sheet and extends our cash runway offering operational flexibility to further support the launch of IBSRELA." 

 "SLR is excited to be a long-term partner with Ardelyx as they launch and commercialize IBSRELA," said Anthony Storino, Head of Life Science Finance at SLR. "We are delighted to partner with Ardelyx during this important time of transition to a commercial company, and this significant commitment of capital represents that belief and our commitment to financing life sciences companies across all stages of development."

The loan agreement provides for a senior secured term loan facility with a maturity date of March 1, 2027 and an interest only period through March 2024. Under the terms of the loan agreement, $27.5 million was drawn at closing, and will be used by the company to repay in full the 2018 term loan agreement with Solar Capital Ltd. and Western Alliance, under which the interest only period had expired. Ardelyx may also borrow an additional $22.5 million upon under the new facility with SLR on or prior to July 25, 2023; provided that the company has received approval by the U.S Food and Drug Administration ("FDA") for its New Drug Application ("NDA") for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis on or before December 31, 2022, and that the company has achieved certain product revenue milestones targets. The term loan has an interest rate of 7.95% plus the 30-day LIBOR. Additional information regarding the transaction can be found in the company's filing with the Securities and Exchange Commission ("SEC") on February 24, 2022, and in its future current and periodic reports to be filed with the SEC. 

IMPORTANT SAFETY INFORMATION

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 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 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 distention (3% vs