Ardelyx (ARDX) Conference September 03, 2025 01:00 PM ET Speaker0We're gonna start the afternoon session. I'm Yigal Nachimovitz, biotech analyst at Citi. This is our, back to school bio biopharma summit in Boston. If you have questions, if you're in the audience, just, you know, you can chime in with the microphones. And also the for those listening online, welcome.So the next session is with Ardellix, and I have with me the senior senior management, Mike Mike Robb, president and CEO Justin Ren, CFO and Eri ...

Financial Data and Key Metrics Changes - The company reported total revenues of $74.1 million for Q1 2025, a 61% increase compared to $46 million in Q1 2024 [19] - Net sales revenue for IBSRELA was $44.4 million, reflecting a 57% increase year-over-year [19] - Exposa generated net sales revenue of $23.4 million, up approximately 55% from $15.2 million in the same quarter last year [19][21] - The company recorded a net loss of approximately $41.1 million or $0.17 per share, compared to a net loss of $26.5 million or $0.11 per share in the prior year [23] Business Line Data and Key Metrics Changes - IBSRELA experienced strong prescription demand, with one of the highest prescription demand quarters to date [6] - Exposa grew by 30% year-over-year when excluding a one-time gross to net adjustment for return reserve release [7][21] - The gross to net deduction for IBSRELA was 34.8%, expected to improve throughout the year [20] Market Data and Key Metrics Changes - The IBS C market traditionally contracts in Q1, which was observed this year, but the company remains optimistic about recovery in subsequent quarters [31] - The dialysis market is undergoing significant disruption due to the loss of Medicare Part D coverage for phosphate-lowering therapies, impacting Exposa's market dynamics [8] Company Strategy and Development Direction - The company is focused on driving strong commercial execution for IBSRELA and navigating access complexities for Exposa [10] - The strategic imperatives include raising awareness of IBSRELA and positioning it as a first-line treatment for appropriate patients [13] - The company aims to achieve peak annual net sales revenue of over $1 billion for IBSRELA and $750 million for Exposa [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of IBSRELA and Exposa, citing strong patient demand and effective commercial strategies [5][10] - The company is closely monitoring market dynamics and will provide further updates as the landscape evolves [9] - Management remains committed to building long-term value for shareholders despite current market challenges [10] Other Important Information - The company received a $5 million milestone payment from a partner in China following the approval of a cannabinoid for hyperphosphatemia [22] - Research and development expenses increased to $14.9 million, reflecting greater engagement with scientific and medical communities [22] Q&A Session Summary Question: Expectations for the IBS C market improvement in Q2 - Management expects the IBS C market to improve as the year progresses, based on strong prescription demand observed in Q1 [31][32] Question: Details on the return reserve and its impact - The return reserve was deemed unnecessary due to zero returns and limited bottles in distribution, leading to modest improvements in gross to net going forward [29][30] Question: Insights on the Q1 contraction and its differences from previous years - The contraction is consistent with historical trends, but the company remains optimistic about future growth [35][37] Question: Long-term gross to net targets and updates on the China launch - Long-term guidance for gross to net is expected to be around 30% plus or minus 5% [40] Question: Discrepancies between reported revenue and script data for IBSRELA - Management acknowledged fluctuations in scripts and emphasized the importance of focusing on guidance rather than individual quarter performance [48][50] Question: Metrics for assessing the expanded field force's impact - Key metrics include increases in activity, new riders, and new/refill prescriptions, all of which showed positive trends in Q1 [56][57] Question: Updates on the Kidney Patient Act and potential external asset acquisitions - The Kidney Patient Act is viewed as a call option, and the company is actively pursuing external assets in renal and GI spaces [102][104]