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3/9/2026
Good morning and welcome to ARS Pharmaceuticals' fourth quarter and full year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the company's prepared remarks, we will open the line for questions. Please be advised that today's conference is being recorded. I will now turn the call over to Justin Chukma, Chief Business Officer. Please go ahead.
Good morning and thank you for joining our fourth quarter and full year 2025 earnings conference call. With me on the call are Richard Lowenthal, our co-founder, president, and CEO, Eric Karras, our chief commercial officer, and Kathy Scott, our chief financial officer. Earlier this morning, we issued a press release detailing our financial results and commercial highlights for the fourth quarter and full year 2025. That press release and the slide presentation that we will refer to during today's call are available in the Investors and Media section of our website. Before we begin, please note that today's remarks may contain forward-looking statements. Actual results may differ materially. Please refer to our press release and SEC filings for further risk disclosures. With that, I'll turn the call over to Rich.
Thank you, Justin. Good morning, everybody, and thank you for joining us. 2025 was our first full year for ARS as a commercial company. It was a year focused on building infrastructure, educating the market, and learning as we introduce a new treatment into a well-established therapeutic category. NEFI is the only FDA-approved needle-free treatment for type 1 allergic reactions, including anaphylaxis. Real-world data from our NEFI experience program published in the Annals of Allergy, Asthma, and Immunology, showed that approximately 90% of patients experiencing anaphylaxis are effectively treated with just a single dose, consistent with published results for injection-based epinephrine products. These data support NEFI's profile as a safe, effective, and reliable treatment, which reinforces confidence among healthcare providers and patients. For our first full year of commercial sales, we generated $72.2 million in net product revenue. That performance reflects meaningful physician engagement and patient uptake across multiple commercial drivers, which Eric will discuss in detail. At the same time, quarterly progression has been shaped by the structural dynamics of this category, particularly the refill dominance, electronic prescribing patterns, prior authorization requirements, and seasonal factors such as deductible resets and back-to-school demand. Growth has not yet followed a linear trajectory, consistent with products launched in a mature refill-driven market. We believe this reflects market structure rather than underlying demand for NEFI. Legacy auto-injectors benefit from decades of embedded renewal behavior within physician workflows. Approximately half of these prescriptions are refills, most written electronically without an office visit. As a new entrant, NEFI has relied on new prescriptions, and we have not yet reached the point where expired NEFI product contributes to volume through refills. New prescriptions require office visits, education, workflow adoption, and administrative time, all of which introduce friction early in the launch. These realities informed our commercial team, and we have refined our execution approach going into 2026. As part of the continued refinement of our strategy, beginning the second quarter, we will expand our sales force and realign territories to increase engagement with our priority accounts. Importantly, this is funded through reallocation of existing commercial resources and will not increase our plan SG&A expense in 2026. We also strengthened our virtual and digital strategy. Given the dominance of electronic refills, long-term success requires participation in renewal workflows, not just influence of the initial prescription. Our Get NEFI on Us program at getnefi.com offers commercially insured patients a free virtual visit with a prescriber, along with a zero copay for eligible patients. Getnefi.com is designed to reduce administrative barriers and streamline patient transition from autoinjectors to NEFI. In parallel, we refreshed our DTC campaign early this year to emphasize practical real-world use, including fear-free administration and portability of NEFI. We are still early in building up the getnefi.com awareness. However, engagement indicators have been encouraging so far. Collectively, these efforts are intended to improve consistency and scalability over time, As we move forward into 2026, our focus remains on disciplined execution. Our priorities fall into three categories, access, adoption, and advancement. On access, we are committed to expanding unrestricted coverage with the remaining major PBM, CVS Caremark, where discussions are ongoing. In a high-volume category like epinephrine, prior authorization requirements can create meaningful administrative friction. Reducing that burden remains an important objective. We ended 2025 with approximately 93% overall commercial coverage, inclusive of plans that may still require prior authorization at approximately 57% of covered lives have access without prior authorization. On adoption, we are focused on deepening engagement in high-volume practices, improving workflow integration, and building the installed patient base. As the installed base matures and product reaches expiration cycles, renewal contributions should become increasingly relevant beginning later in 2026 and into 2027. On advancement, our international partners continue to secure regulatory approvals across Europe, China, Japan, and Australia, reinforcing the broader global opportunity of NEFI. We expect continued regulatory progress and partner-led launches in these territories in 2026. We also continue to advance our pipeline in the treatment of chronic spontaneous urticaria flares with interim data expected in the second half of 2026 from our ongoing Phase 2b trial. This is an indication with peak sales potentially as large as nephi and anaphylaxis. We remain on track to finish this study by the end of 2026 with phase three beginning in mid-2027. In summary, NEFI is a differentiated product operating within a large established market. We have made important progress in our first full commercial year, and we are applying those learnings to sharpen execution and improve consistency going forward. With that, I'll turn the call over to Eric to share more details on our commercial execution.
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