• Total Revenue: $98.2 million in Q3 2024, up from $56.4 million in Q3 2023.
• IBSRELA Net Product Sales: $40.6 million in Q3 2024, nearly double from Q3 2023, with 15% growth from Q2 2024.
• XPHOZAH Net Product Sales: $51.5 million in Q3 2024, up from $37.1 million in Q2 2024.
• Gross to Net Deduction for IBSRELA: 30.0% in Q3 2024, consistent with prior quarter.
• Gross to Net Deduction for XPHOZAH: Improved to 19.3% in Q3 2024 from 21.4% in Q2 2024.
• Research and Development Expenses: $15.3 million in Q3 2024, up from $8.6 million in Q3 2023.
• Selling, General, and Administrative Expenses: $65.0 million in Q3 2024, up from $32.7 million in Q3 2023.
• Net Loss: Approximately $800,000 or less than $0.01 per share in Q3 2024.
• Cash Position: $190.4 million as of September 30, 2024, with a pro forma cash balance of over $240 million after drawing $50 million from amended debt agreement.

• Warning! GuruFocus has detected 5 Warning Signs with ARDX.

Release Date: October 31, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• IBSRELA recorded a 15% increase in net sales over the second quarter, indicating strong demand and growth.
• XPHOZAH achieved a 39% increase in net sales revenue quarter over quarter, showcasing its successful launch and market acceptance.
• Ardelyx Inc (NASDAQ:ARDX) reported $98.2 million in total revenue during the third quarter, a significant increase from $56.4 million in the same period in 2023.
• The company has a strong cash position with over $240 million, providing financial flexibility for future opportunities.
• The expansion of the IBSRELA sales team was completed, which is expected to drive further growth and adoption.

Negative Points

• There is uncertainty around Medicare coverage for XPHOZAH, which could impact future sales and patient access.
• The company is engaged in a lawsuit against CMS regarding the inclusion of oral-only therapies in the dialysis bundle, which adds legal and regulatory risk.
• Research and development expenses increased to $15.3 million in the third quarter, reflecting higher costs associated with medical engagement and clinical trials.
• Selling, general, and administrative expenses rose to $65.0 million, driven by commercial activities and sales team expansion, impacting profitability.
• Despite strong revenue growth, the company reported a net loss of approximately $800,000 for the third quarter.

Q & A Highlights

Q: What percent of XPHOZAH sales are not part of the Medicare bundle, and how do you plan to expand your product portfolio? Also, when do you expect IBSRELA to reach $1 billion in sales? A: Approximately 40% of XPHOZAH sales are non-Medicare. We are exploring expansion opportunities, led by Mike Kelleher, leveraging our strong balance sheet. As for IBSRELA, it's too early to specify a timeline for reaching $1 billion in sales, especially since we just completed our sales team expansion.

Q: What are the commercial strategies for XPHOZAH in 2025, and why does the IBSRELA guidance seem conservative? A: We aim for physicians to continue prescribing XPHOZAH based on clinical need, regardless of Medicare coverage changes. The IBSRELA guidance reflects our cautious approach, but we are optimistic due to the recent sales team expansion and positive feedback from the American College of Gastroenterology meeting.

Q: Can you elaborate on your plans for educating prescribers about XPHOZAH ahead of January 1, and how are you engaging with payers? A: We are advising prescribers to maintain their current practices, emphasizing the clinical benefits of XPHOZAH. Our communication with payers remains consistent, focusing on ensuring patient access through our ArdelyxAssist program.

Q: Have you made any progress with the injunction to temporarily halt the inclusion of oral therapies in the dialysis bundle for 2025? A: We hope for a court decision on the injunction before the end of the year, but there are no additional insights to provide at this time.

Q: What feedback are you receiving from doctors about XPHOZAH usage, and how are they utilizing it for their patients? A: Physicians are using XPHOZAH on-label alongside binders and are seeing significant results in patients who are not well-managed on binders alone. This feedback reinforces our confidence in XPHOZAH's potential.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.