Ardelyx(ARDX) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of September 30, 2022, the company had total cash, cash equivalents, and short-term investments of $90.6 million [25] - Third quarter net product sales of IBSRELA were approximately $4.9 million, with total revenue of approximately $5 million [25] - R&D expenses were $7.5 million for Q3 2022, a decrease of 68.5% compared to $23.7 million for the same quarter in 2021 [26] - SG&A expenses were approximately $18.7 million for Q3 2022, a decrease of 5.3% compared to $19.7 million for the same quarter in 2021 [27] - The net loss for the quarter was $22.9 million or $0.14 per share, compared to $43.6 million or $0.42 per share for the same quarter in 2021 [27] Business Line Data and Key Metrics Changes - IBSRELA is gaining traction with net product sales of nearly $7 million from launch to the end of Q3 2022 [13] - 60% of healthcare providers (HCPs) have seen IBSRELA representatives, with 64% overall awareness level [16] - 90% of aware HCPs rated IBSRELA as an advance versus existing therapies, with 44% identifying as current prescribers [16] Market Data and Key Metrics Changes - The overall script market for IBS-C indicated drugs is about 5 million scripts, with a potential for high single-digit market share at peak [50] - The company is seeing favorable prior authorization rates from payers, indicating a positive access environment for IBSRELA [57] Company Strategy and Development Direction - The company aims to establish IBSRELA as a critical part of the IBS-C treatment armamentarium, leveraging a targeted promotional approach [19] - The strategy includes focusing on HCPs managing high volumes of IBS-C patients and utilizing digital initiatives for engagement [21][22] - The company is preparing for an upcoming regulatory milestone with XPHOZAH, a treatment for controlling serum phosphorus in adult patients with CKD on dialysis [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the traction and momentum of IBSRELA, indicating a clear line of sight to financial breakeven [31] - The company remains committed to being good stewards of capital and is optimistic about the upcoming Advisory Committee meeting for XPHOZAH [31] Other Important Information - The company strengthened its balance sheet with $35 million expected from a recent NDA submission by its Japanese partner, Kyowa Kirin Corporation [9] - The company has completed several important transactions to maintain a strong cash position, including refinancing term loan debt [28] Q&A Session Summary Question: Upcoming Advisory Committee details - The company cannot provide specifics about the Advisory Committee meeting but will have voting questions available two days before the meeting [36] Question: IBSRELA launch cadence and revenue momentum - Management expects consistent growth and is encouraged by the early user base, but specific guidance is not provided at this time [39] Question: Physician awareness and tenapanor - There is a high level of awareness and interest in XPHOZAH among the nephrology community, supported by comprehensive clinical development programs [46] Question: Patient numbers on IBSRELA therapy - The company is not providing specific guidance on patient numbers yet but is compiling metrics regularly [49] Question: Impact of plan resets on sales - The payer policies are stable, and the company is not heavily dependent on the standard D patient segment, which may fluctuate due to plan resets [69]