ARS Pharmaceuticals, Inc.

Good morning, and welcome to ARS Pharmaceuticals 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'll now turn the call over to Justin Chokmah, Chief Business Officer. Please go ahead.

Good morning, and thank you for joining our third quarter 2025 earnings conference call. With me on the call are Richard Lowenthal, our co-founder, president, and CEO, Eric Paris, our chief commercial officer, and Kathy Scott, our CFO. This morning, we issued a press release detailing financial results and commercial highlights. That press release and the slide presentation, which we'll refer to today during today's call, are available in the investors and media section of our website at ars-pharma.com. Before we begin, please note that today's remarks and slide presentation 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 to discuss what has been a pivotal quarter for ARS Pharma, driven by the continued momentum of NAFI in the U.S. and around the world. Third quarter marks a true inflection point for our business. As you can see on slide three, U.S. net product revenue for NEFI grew again quarter over quarter, reaching $31.3 million in Q3, representing a 2.5-fold increase from the prior quarter and exceeding consensus expectations of $28.3 million. This change reflects a strong growth in new patient starts and overall demand for NEFI. Surveys among NEFI users indicate that we can expect durable utilization and reoccurring refill behavior. Trends that we expect will continue to build as both coverage and awareness expand. These results show that our multifaceted commercial strategy is delivering results. Later this month, our first analysis of real-world treatment outcomes from the NEFI Experience Program will be published in the Annals of Allergy, Asthma, and Immunology, with a total of 554 patients treated. Findings show that about 9 out of 10 patients experiencing anaphylaxis were effectively treated with a single dose of NEFI, which is consistent with outcomes for epinephrine injections, where either IM injection or EpiPen require a second dose approximately 10% of the time to resolve the event. Updated results in 680 patients were highlighted in an oral presentation at ACAAI, and reinforce that NEFI delivers equivalent outcomes to injection products in real-world use. On top of a series of case reports also presented at ACAAI by independent physicians, we expect additional peer-reviewed publications in 2026 that will further validate NEFI's clinical experience with injection products. Before Eric reviews our commercialization details, there are two important topics I want to touch on today. why NEFI's revenue trajectory isn't accurately reflected in IQVIA script data. And second, what we've learned from recent market dynamics, including back-to-school seasonality. Starting with IQVIA, as we've noted before, the weekly IQVIA rapid data, which are generally available on a paid subscription basis, provide a directional view of prescription activity, but are not completely accurate and reliable measures of NEFI's true performance or market share. IQVIA data sets often exclude a number of channels that are central to our business, including certain retail, mail order, and specialty pharma volumes, as well as bulk purchases by institutions and clinics that buy directly through wholesalers. These additional sales are not accurately captured by IQVIA and are variable from week to week and thus cannot be predicted. Turning to market dynamics. During the back-to-school season, allergists and pediatricians experience a huge surge in patient visits, including checkups and sports physicals. That higher patient volume means that HCPs have significantly less time per an appointment, typically just five to seven minutes per patient, leaving little to no opportunity to discuss new treatment options or changing prescriptions. That challenge is even greater for patients who still need prior authorizations. As a result, In the second half of Q3, we saw a temporary pause in market share growth. Importantly, though, we view this as a one-time event. Looking ahead to Q4, market share growth has resumed, although we anticipate Q4 sales will decrease from Q3 given the overall epinephrine market typically declines about one-third due to seasonality and the holidays. Then as we move into 2026, we expect to return to quarter-over-quarter growth as both market share and overall prescription volumes rise in parallel. To further drive adoption and accessibility, we recently launched our new Get NEFI on Us program at the getnefi.com website. This is an important initiative designed to help patients switch to NEFI year-round with a hassle-free virtual prescriber at no cost to patients if covered by insurance. This program is anticipated to help accelerate sales growth year-round and circumvent the hectic back-to-school season. Eric will share more details, but this program removes much of the patient and physician burden in prescribing NEFI by shifting the prescription, prior authorizations if needed, and patient training to our virtual physician system. Once patients are on NEFI, Physicians can more easily manage refills electronically, or patients can return to getnefi.com to get additional renewal prescriptions. Together with our broader DTC campaign, this initiative makes it simpler than ever for patients to experience the benefits of NEFI and represents the key driver of long-term adoption. In fact, we already have proof of what hassle-free prescribing can do for NEFI sales. Your NEFI was launched in Germany in late June, where there is a more seamless prescribing experience without additional HCP paperwork. The slope of the market share capture in just the first few months has been three times higher than what we've seen in the U.S., showing just how impactful growth can be when administrative burdens are not a barrier. This is also a strong signal for our global growth trajectory. NEFI received approval in Japan in September with launch anticipated to start in the fourth quarter of 2025. We expect approvals in Canada by the first quarter of 2026 with launch expected in the first half of 2026. And we expect approval in China in the first half of 2026. We expect that as these launches begin, they will start to contribute to the total revenue and cash proceeds in the second half of next year as distribution scales across partner regions. On the clinical front, enrollment is ongoing in our Phase IIb urticaria trial, and we are on track for top-line data in the middle of 2026. This indication represents a major label expansion opportunity in a 2 million patient market in the United States. Early market research with allergists support that our nasal spray product, if approved, could be prescribed to more than 60% of all of their CSU patients, irrespective of whether those patients are on antihistamine, biologics, or combination therapy. Finally, in September, we secured an up to $250 million term loan facility, from which we drew down $100 million initially. Strategically, we chose this structure in partnership with our largest shareholder over other capital vehicles to increase commercial investment and further strengthen our balance sheet without dilution. This reflects our confidence and that of our investors in NEFI's durable cash flow profile and long-term potential. Our planned investments are geared towards expanding the current market and improving adherence and refill rates, reengaging lapsed patients and activating untreated patients, as well as converting the current $2 billion annual U.S. epinephrine market at NEFI's net price. With this financing, we ended Q3 with approximately $288 million in cash, cash equivalents, and short-term investments, giving us even more flexibility to support our evolving commercial initiatives. In summary, we're building momentum across every dimension of our business, from revenue growth and market share growth to access, real-world evidence, and global expansion, all while maintaining a strong balance sheet. I'll now turn it over to Eric to provide more detail on our U.S. commercial performance. Thanks, Rich.