ARS Pharmaceuticals, Inc.

Good morning and welcome to ARS Pharmaceuticals' first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the company's prepared remarks, we'll open the line for questions. Please be advised that today's conference is being recorded. I will now turn the call over to Justin Chokmah, Chief Business Officer. Please go ahead.

Good morning and thank you for joining our first quarter 2026 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 first quarter of 2026. That press release and our slide presentation 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, and good morning, everybody, and thank you for joining us on the call. We are off to a strong start in 2026, following our first full year as a commercial company and building momentum across the business. During the quarter, we continue to focus on key drivers of growth, which are expanding access, making NEFI more affordable to patients and caregivers, increasing prescriber adoption, and strengthening consumer awareness. We have made progress in further positioning NEFI as a differentiated and increasingly scalable treatment within a large market of type 1 allergic reactions, including anaphylaxis. In the first quarter, we generated $22.7 million in total revenue. This includes $17.5 million in U.S. net product revenue for NEFI, which represents three times the volume of NEFI prescriptions year over year and more than double the revenue. Our sales growth in the first quarter is a positive achievement, given that the first two months of the year are typically the lowest volume period for epinephrine. This is due to the reset of health insurance deductibles on January 1st. As additional context, epinephrine is in a mature refill-driven market where approximately half the prescriptions are renewals typically written electronically without an office visit. As a new entrant, NEFI has largely relied on new in-office prescriptions to date. We are now beginning to see shifts in the underlying market dynamics with improved payer access, reduced prescribing friction, and maturation in the refill cycles for our installed base. These factors, alongside the growth we've seen in demand, prescriber engagement, and patient uptake, provide the foundation for more consistent and scalable long-term growth going forward. Our NEFI priorities remain focused on three areas, access, affordability, and adoption. Starting with access, the primary barriers influencing prescriber adoption in this category are the prior authorization process and perceived misperceptions of out-of-pocket costs. Even when prior authorization approval is obtained, the process creates friction that can delay or deter prescribing. Addressing these barriers is critical focus for this year. We ended the first quarter with approximately 90% commercial coverage, of which 57% was without prior authorization. At the state level, Florida, a bellwether Medicaid state, has added NEFI to its unrestricted formulary effective July 1st, with many additional states progressing towards adding NEFI to their preferred drug lists. This brings us to a total of nine states covering NEFI under Medicaid. The most consequential recent development is at CVS Think, which covers Caremark, Aetna, and Anthem. Based on feedback from CVS in late April, we've submitted an updated proposal to add NEFI to their commercial formularies, removing the PA requirement and targeting a July 1st effective date. This proposal is now in the final stages of the formulary approval process. Based on the anticipated timeline to approval, we should be able to provide more definitive updates within the next few weeks. This timing has been extended beyond the original expectations due to the focus of PBMs on new legislation and the ongoing FTC-related interactions. Given Caremark's coverage and the typical alignment of Aetna and other zinc-related plans, a NEFI formulary addition would meaningfully expand access for patients this summer and bring the proportion of covered lives without prior authorization in line with other epinephrine autoinjector products. In addition to our work with Caremark, we recently launched a new initiative to help make NEFI more affordable for patients. We anticipate this will further improve healthcare provider willingness to prescribe NEFI by addressing the misperception of high out-of-pocket costs for patients. This new system gives patients the ability to get the NEFI $199 cash price directly through retail pharmacies. Historically, the $199 cash price was available only through our specialty pharmacy and telehealth channels. Patients whose prescriptions were not covered by commercial insurance and who filled NEFI at retail pharmacies could be quoted the product's WAC price plus pharmacy markup fees, in some cases resulting in out-of-pocket costs of over $1,000. These high retail prices created confusion and impacted prescribing decisions. Under the new program, our patients with rejected commercial claims who fill their prescriptions at retail pharmacies will pay no more than $199. We expect this program will increase the number of NEFI prescriptions that are purchased by the patient and will help align healthcare provider perception with the reality of NEFI's maximum $199 cash price. This is completely in line with other epinephrine autoinjector products. With the introduction of the $199 retail pharmacy cash option and CVS progressing through the final stages of its approval process, we believe that the proportion of covered lives with access to NEFI without prior authorization is positioned to expand meaningfully over the coming months. As payer access continues to improve, prescribing patterns should strengthen, particularly as we approach the back-to-school season. Together, these initiatives are expected to support sustained broad-based adoption with the commercial impact building progressively through the second half of 2026 and 2027. Turning to adoption, we intend to deepen our reach within the highest volume prescribing practices and to build a durable patient base. In May, we expanded our sales force to 148 people, with a focus on prioritizing accounts that drive the greatest prescription volume. As the patient base matures and product reaches expiration cycles, we expect refill contributions to scale later this year and into 2027. At the end of March, the minimum age restriction was removed from the NEFI label by FDA, enabling pediatric patients who are greater than 33 pounds and under four years of age to get access to treatment. We believe pediatric adoption will accelerate further as the recently approved broadened FDA label takes hold and real-world evidence of effect continues to build. Further, through our growing NEFI in schools program, there have been over 200 successful uses of NEFI in treating anaphylactic episodes reported by school nurses with very positive feedback. These experiences are helpful in building greater comfort and familiarity with NEFI among patients and caregivers who often consult their school nurses, as well as with prescribers. Beyond the U.S., our partners continue to position NEFI for market adoption in other geographies. Most recently, in April, Health Canada approved NEFI as the first and only needle-free emergency treatment for allergic reactions, including anaphylaxis, with commercial launch by our partner, ALK, later in 2026. Just before that, in March, the European Commission granted marketing authorization for your NEFI one milligram, further extending the NEFI access for younger children at risk of anaphylaxis in the European region. Overall, we are well positioned heading into the important summer months and second half of this year to take full advantage of expanded access and improved affordability for NEFI. Let me now turn the call over to Eric to share more details of our commercial execution.