NeurAxis (NYSEAM:NRXS) Q4 2025 Earnings call March 19, 2026 09:00 AM ET Company ParticipantsBen Shamsian - VP of Investor RelationsBrian Carrico - President and CEOKaren Sterling - Managing DirectorTimothy Henrichs - CFOConference Call ParticipantsChase Knickerbocker - AnalystNone - AnalystOperatorLadies and gentlemen, thank you for standing by. Welcome to the NeurAxis Report, Q4 2025 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be ...

Summary of Ardelyx Conference Call Company Overview - **Company**: Ardelyx (NasdaqGM: ARDX) - **Industry**: Biotechnology, focusing on gastrointestinal and renal diseases Key Points Commercial Performance - **IBSRELA**: Achieved 73% growth in 2025, with expectations for 2026 revenue between $410 million and $430 million, indicating a 50% growth rate [8][16][66] - **XPHOZAH**: Experienced 41% growth in the non-Medicare business and 9% growth in total dispenses [8][37] Growth Drivers for IBSRELA - **Sales Force Expansion**: Doubled sales force size to optimize reach to 14,000 healthcare providers (HCPs) [11] - **Field Reimbursement Team**: Expanded to assist in prescription fulfillment [12] - **Distribution Network**: Focus on limited distribution networks to improve prescription fulfillment rates [12] - **Patient Engagement**: Engaging motivated patient populations to drive awareness and prescriptions [13] Long-term Projections - **Revenue Target**: Guidance of over $1 billion for IBSRELA by 2029, requiring a compound annual growth rate (CAGR) of approximately 38% [14][16] - **Patient Population**: Targeting 200,000 to 250,000 patients out of a total IBS-C population of 5-7 million [20] CIC Initiative - **CIC Market Size**: CIC patient population is estimated to be 2-3 times larger than IBS-C [29] - **Trial Design**: EXCEL trial powered to detect a 14% difference between tenapanor and placebo, with enrollment expected to complete by year-end [26] - **Patient Profile**: Targeting patients who have not achieved relief from existing treatments [75] XPHOZAH Insights - **Revenue Stability**: Non-Medicare business is stabilizing, with a focus on maintaining access for patients [37][39] - **Investment Strategy**: Careful tracking of ROI on investments to ensure continued growth [40][41] Intellectual Property (IP) and Future Opportunities - **IP Protection**: Strong IP estate with composition of matter patent until 2033 and method of use patent until 2034 [50] - **Next-Gen NHE3 Inhibitor**: Increased solubility and potency may lead to expanded therapeutic opportunities [51] Financial Guidance - **Operating Expenses**: Guided for $520 million in 2026, with a steady increase in expenses expected [63][66] - **Top-Line Growth**: Revenue growth is expected to outpace expense growth, with cash generation supporting investments [66][70] Market Perception - **Underappreciated Value**: The market may not fully recognize the potential for significant revenue growth and the strategic positioning of Ardelyx in treating chronic diseases [85][86] Additional Insights - **Payer Relationships**: Ongoing discussions with payers to enhance access for IBSRELA and CIC indications [83] - **Commercial Infrastructure**: Investments in commercial infrastructure are aimed at sustaining long-term growth [31] This summary encapsulates the key insights and strategic directions discussed during the Ardelyx conference call, highlighting the company's growth trajectory, product pipeline, and market positioning.

Core Insights - The company, CelLBxHealth, is undergoing a strategic transformation and is eager to share updates on its new business plan [1]. Group 1: Leadership and Experience - Peter Collins, the CEO, has extensive experience in oncology, diagnostics, and drug development, including a significant role at GSK [4]. - Sinead Armstrong, the Finance Director, has been with the company for 25 years, holding various roles in finance for the last 7 to 8 years [2]. - Dr. Jan Groen, the Executive Chairman, has a strong background in the diagnostic industry and has successfully transitioned companies from Europe to the U.S. [3].

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were reported at $3.4 million, primarily from WICANT sales, reflecting a significant increase in demand [6][16] - The GAAP net loss for Q1 2025 was $9.7 million, or $0.10 per share, a reduction from a net loss of $20.3 million, or $0.44 per share in Q1 2024 [17] - Non-GAAP net loss for Q1 2025 was $7.8 million, or $0.08 per share, compared to a loss of $17.8 million, or $0.38 per share in the same period last year [17] Business Line Data and Key Metrics Changes - WICANT's dispensed applicator units increased by 16.7% over Q4 2024, surpassing 10,000 units for the first time since its launch [6][7] - Gross product margins for Q1 2025 were approximately 88%, with product revenue costs amounting to $400,000, including $47,000 in obsolete inventory costs [16][17] - Research and development expenses decreased to $2.3 million in Q1 2025, down from $4.9 million in Q1 2024, primarily due to reduced clinical trial expenses [17] Market Data and Key Metrics Changes - The company is focusing on territories with high prevalence of molluscum contagiosum and has established strong insurance coverage, leading to improved sales force productivity [8][9] - The company is expanding its distribution network by adding local independent pharmacies alongside national specialty pharmacy partners [9] Company Strategy and Development Direction - The company is executing a focused commercialization strategy aimed at driving demand for WICANT, which is expected to become the standard of care for molluscum contagiosum [19] - The clinical pipeline includes advancing the phase three program for WICANT in treating common warts and the development of BP315 for basal cell carcinoma, which has shown promising results [7][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing positive feedback from healthcare professionals and improved patient access [19] - The company is exploring opportunities to strengthen its balance sheet while continuing to advance its commercial and clinical development efforts [18] Other Important Information - The company appointed Dr. Noah Rosenberg as Chief Medical Officer and Dr. Gavin Corcoran to the Board of Directors, enhancing its leadership team [13][14] - As of March 31, 2025, the company had cash and cash equivalents of $29.6 million, which may not be sufficient for one year of operations unless certain milestone payments are received [17][18] Q&A Session Summary Question: Could you discuss your success in targeting pediatricians and the current split of pediatric dermatologists versus pediatricians writing WICANT? - Management noted an increasing number of pediatricians prescribing WICANT, with strong advocacy from dermatologists as well [21][23] Question: What preparations are ongoing to capture potential summer patient demand for WICANT? - Management indicated marketing efforts are in place to build awareness of molluscum contagiosum and the availability of WICANT, anticipating a potential seasonal uptick in demand [24][25] Question: How is the conversion time between accounts receivable and top-line revenue for WICANT trending? - Management stated that with normalized inventory levels and smaller, more frequent orders, they expect stabilization in cash conversion from receivables [30][31] Question: What is the current split between commercial and Medicaid coverage for molluscum? - Management indicated a higher percentage of pediatric patients are covered under Medicaid, while dermatology patients tend to have more commercial coverage [36][37] Question: What trends are being observed in reordering and the number of applicators per patient? - Management reported solid growth and retention in customer reorders, indicating positive clinician experiences with the product [42][43]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported total revenues of $3,400,000, primarily from WICANT, with gross product margins around 88% [16][17] - The GAAP net loss was $9,700,000 or $0.10 per share, a significant improvement from a net loss of $20,300,000 or $0.44 per share in Q1 2024 [17] - Non-GAAP net loss for Q1 2025 was $7,800,000 or $0.08 per share, compared to $17,800,000 or $0.38 per share in the same period last year [17][18] Business Line Data and Key Metrics Changes - WICANT's dispensed applicator units increased by 16.7% over Q4 2024, surpassing 10,000 units for the first time since its launch [6][7] - Collaboration revenues totaled $17,000 in Q1 2025, related to the supply of applicators to Torii Pharmaceutical [16] Market Data and Key Metrics Changes - The company is focusing on territories with high prevalence of molluscum and has established strong insurance coverage, leading to improved sales force productivity [8][9] - The company is expanding its distribution network by adding local independent pharmacies alongside national specialty pharmacy partners [9] Company Strategy and Development Direction - The company is executing a focused commercialization strategy aimed at driving demand for WICANT, which is expected to become the standard of care for molluscum contagiosum [19] - The clinical pipeline includes advancing the phase three program for WICANT in treating common warts and the development of BP315 for basal cell carcinoma [7][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing positive feedback from healthcare professionals and improved patient access [19] - The company is exploring opportunities to strengthen its balance sheet while advancing commercial and clinical development efforts [18] Other Important Information - The company appointed Dr. Noah Rosenberg as Chief Medical Officer and Dr. Gavin Corcoran to the Board of Directors, enhancing its leadership team [13][14] Q&A Session Summary Question: Discussion on targeting pediatricians and summer demand - Management noted an increasing number of pediatricians prescribing WICANT, with marketing efforts aimed at building awareness for the treatment [22][25] Question: Conversion time between accounts receivable and revenue - The company offers sixty-day payment terms to distributors, expecting stabilization in cash conversion as inventory levels normalize [31][32] Question: Overall TAM for molluscum and coverage split - Management indicated a significant percentage of pediatric patients are covered under Medicaid, while dermatologists have a higher percentage of commercial pay [36] Question: Trends in reordering and applicators per patient - The company is seeing solid growth in customer retention and reordering, indicating positive clinician experiences with the product [42][43]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [26] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [26] - Gross margin in Q1 2025 was 84.4%, down from 88.4% in Q4 2024, attributed to a higher growth rate of discounted financial assistance patients [27][28] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [30] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 2024, 43% in Q4 2024, and 39% in Q1 2025 for IV stem technology [9] - 300 patients were treated in Q1 2025, an annualized rate of 1,200 patients, representing only 0.2% of the 600,000 severely affected children in the U.S. [18] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase [16][21] Market Data and Key Metrics Changes - Total covered lives increased from 4 million a year ago to approximately 51 million today [11] - The company expects to see increased orders following the publication of independent guidelines by the academic society [33][34] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the effective date of the category one CPT code on January 1, 2026 [25][20] - The strategy includes leveraging strong published data to drive insurance expansion and sustainable revenues [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding continued revenue growth due to the expected increase in insurance policy coverage and the category one CPT code [21][25] - The company is cautiously optimistic about the timeline for receiving guidelines and subsequent policy coverage from payers [33][35] Other Important Information - The company settled a lawsuit for $750,000, which will be paid in equal monthly installments starting January 2026 [42] - The legal settlement is viewed positively as it mitigates further risks and legal fees [42][43] Q&A Session Summary Question: When do you expect the guidelines to be published? - Guidelines are expected to be published by the end of the month, with orders anticipated to increase based on policy coverage from those guidelines [33][34] Question: How do you see your operating expenses in the near and medium term? - Operating expenses are expected to increase as investments in sales and marketing are necessary, but as a percentage of sales, they are expected to decrease [36][37] Question: Can you provide more color on RED and its launch? - The response to the RED soft launch has been stronger than expected, with a significant need for the technology noted [38][40] Question: Can you provide details on the legal settlement? - The legal settlement from 2019 will be paid in installments starting January 2026, and it is seen as a positive step for the company [41][42]