Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Ardelyx Inc (ARDX, Financial) reported significant year-over-year revenue growth, with total revenue reaching $73.2 million in Q2 2024, compared to $22.3 million in the same period in 2023.
- IBSRELA's revenue nearly doubled compared to the second quarter of last year, demonstrating strong market demand and effective commercial strategies.
- XPHOZAH showed remarkable growth, with $37.1 million in net product sales revenue in Q2 2024, up from $15.2 million in Q1 2024.
- The company maintains a strong cash position with $186 million in cash, cash equivalents, and short-term investments as of June 30, 2024.
- Ardelyx Inc (ARDX) is actively advocating for patient access to XPHOZAH, including filing a lawsuit against CMS to prevent the inclusion of oral-only phosphate lowering therapies in the Medicare bundle.
Negative Points
- The company is facing challenges with CMS regarding the inclusion of XPHOZAH in the Medicare bundle, which could restrict patient access.
- Selling, general, and administrative expenses increased significantly to $64.7 million in Q2 2024 from $27.2 million in the same period of 2023, primarily due to commercial launch activities.
- Ardelyx Inc (ARDX) reported a net loss of approximately $16.5 million for Q2 2024, although slightly improved from the $17.1 million loss in Q2 2023.
- The gross-to-net deduction for XPHOZAH and IBSRELA remains a variable factor, potentially causing revenue volatility.
- The company has not yet provided specific guidance for XPHOZAH due to ongoing learning about the product's market dynamics and payer mix.
Q & A Highlights
Q: Can you provide guidance on how to model or forecast XPHOZAH sales given potential volatility in gross-to-net calculations?
A: Michael Raab, President and CEO, explained that it's premature to provide specific guidance for XPHOZAH as they are still learning about the product's dynamics. Justin Renz, CFO, added that both products have low inventory in the channel, and the largest variable in gross-to-net is the commercial co-pay program, which can fluctuate based on payer mix.
Q: What other initiatives are you considering to keep XPHOZAH out of the CMS bundle?
A: Michael Raab stated that while they have ongoing work, it's premature to discuss specifics. They are committed to exhausting all options to ensure patient access to XPHOZAH.
Q: Can you quantify the low inventory levels for both products and comment on the SG&A run rate?
A: Justin Renz noted that both products maintain low inventory levels, typically between 1.5 to 2.5 weeks in the channel. Regarding SG&A, they expect to reach an $80 million run rate per quarter by the fourth quarter of this year as they complete the sales force expansion.
Q: How much of the second quarter's performance for IBSRELA was due to new sales reps, and what are your R&D priorities given patent expirations?
A: Michael Raab mentioned that the full impact of the sales force expansion will be seen by the end of the quarter. Regarding R&D, they are exploring complementary programs to their current products, with Mike Kelliher leading these efforts.
Q: What strategies are gaining traction with physicians for XPHOZAH, and how does this affect your outlook for the second half of the year?
A: Michael Raab highlighted that physicians are expanding XPHOZAH use to more patients as they see positive results. This expansion is driven by the drug's effectiveness in controlling serum phosphorus levels, which bolsters their confidence for continued growth.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
