On August 6, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, reported business highlights and financial results for the second quarter ended June 30, 2020 (Press release, Ardelyx, AUG 6, 2020, View Source [SID1234563225]).
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"Over the last quarter, we continued to make critical progress towards our goal of providing our first-in-class therapy tenapanor to adult CKD patients on dialysis with elevated serum phosphorus, a condition, despite traditional therapies, that has been associated with poor survival outcomes," said Mike Raab, president and chief executive officer of Ardelyx. "This past June, we submitted a New Drug Application to the FDA for this indication, and we expect to receive notification of its acceptance for substantive review and our PDUFA date by early September. As part of our filing, we included additional, robust data reconfirming tenapanor’s ability to lower and control serum phosphorous levels at a rate better than those reported with phosphate binders alone. In addition, during the quarter, we augmented our senior leadership team with the hiring of an experienced chief commercial officer and chief financial officer as we prepare for launch and evolving into a revenue-generating company."
Recent Business and Pipeline Updates
Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The filing is supported by three successful Phase 3 studies demonstrating tenapanor’s ability to reduce phosphate levels, with two trials evaluating tenapanor as a monotherapy and the third evaluating tenapanor as part of a dual mechanism approach with phosphate binders.
Released additional positive data from the ongoing NORMALIZE Phase 4 study, which showed that foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of CKD patients on dialysis to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care.
Announced that Ardelyx’s collaboration partner in Japan, Kyowa Kirin Co., Ltd. (KKC), presented data at the European Renal Association-European Dialysis and Transplant Association annual meeting (ERA-EDTA 2020) from a Phase 2 study designed to evaluate if, with tenapanor, patients with hyperphosphatemia undergoing hemodialysis could achieve at least a 30% decrease in mean pill burden while maintaining their serum phosphorus level. The results demonstrated that tenapanor enabled a significant reduction in overall pill burden (mean reduction in phosphate binder pill usage by 80%), while maintaining serum phosphorus control.
Strengthened leadership team with the appointment of two senior executives:
Justin Renz, a veteran biopharma executive with over 20 years of experience, as chief financial officer; and
Susan Rodriguez, a highly experienced global biopharma marketing and sales executive with a proven track record of building commercial organizations and leading successful new product launches, as chief commercial officer
Expected 2020 Milestones
Receive notification from the FDA regarding the acceptance for substantive review of the NDA submission and PDUFA date in September 2020
Initiate the OPTIMIZE clinical trial, a study designed to inform physicians on the integration of tenapanor as a foundational therapy into clinical practice, this year
Present AMPLIFY and PHREEDOM Phase 3 clinical trial results at upcoming medical congresses
Report completed NORMALIZE Phase 4 clinical trial results at an upcoming medical conference
Second Quarter 2020 Financial Results
Cash Position: As of June 30, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $204.8 million, as compared to total cash, cash equivalents and short-term investments of $247.5 million as of December 31, 2019.
Revenue: The company generated $1.8 million in revenue, which primarily represents collaborative development revenue, for the three months ended June 30, 2020.
R&D Expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2020, a decrease of $0.6 million, or approximately 3 percent, compared to $19.5 million for the three months ended June 30, 2019. The decrease was due primarily to a decrease in external R&D expenses, with a $1.1 million decrease in tenapanor-related expenses, as well as a $0.6 million decrease in RDX013 program-related expenses, partially offset by $0.7 million of higher expenses attributable to the research programs being conducted under the Research Collaboration and Option Agreement entered into between Ardelyx and KKC in 2019 and general R&D expenses. Of the overall tenapanor-related decrease, approximately $7.9 million was related to lower clinical study costs due to the winding down of expenses associated with the Phase 3 clinical program for tenapanor for the control of hyperphosphatemia, offset by an out-of-period adjustment that reduced clinical trial expenses by $4.1 million; and an approximately $2.1 million decrease in validation-related manufacturing expenses; offset by increase of $4.6 million related to regulatory expenses that included $2.9 million paid to the FDA for the filing of the NDA for tenapanor for control of serum phosphorus.
G&A Expenses: General and administrative expenses were $7.0 million for the three months ended June 30, 2020, an increase of $1.6 million, or approximately 31 percent, compared to $5.4 million for the three months ended June 30, 2019. The increase was primarily due to an increase in headcount and related personnel costs, including stock-based compensation costs, and an increase in professional services.
Net Loss: Net loss for the quarter ended June 30, 2020 was $25.0 million, as compared to $25.5 million for the quarter ended June 30, 2019.