ARS Pharmaceuticals, Inc.

Good morning and welcome to the ARS Pharmaceuticals 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 today's conference is being recorded. I'll now turn the call over to Justin Chakpa, Chief Business Officer. Please go ahead.

Good morning and thank you for joining our second quarter 2025 earnings conference call. This morning, we issued a press release detailing our financial results and commercial highlights. which is available in the investors and media section of our website at ars-pharma.com. With me on the call are Richard Lowenthal, our co-founder, president, and CEO, who will review recent corporate updates and achievements. Eric Perez, our chief commercial officer, will cover our commercial activities and progress. And Kathy Scott, our CFO, who will provide a summary of our financial results and cash positions. Before we begin, please note that today's remarks may contain forward-looking statements. Actual results may differ materially. Please refer to our earnings 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 our commercial momentum with NEFI in the second quarter of this year and early weeks of the third quarter. We have long believed that a needle-free, portable, and reliable epinephrine treatment option could transform how patients and providers treat severe allergies. The commercial data we will share today confirm that this vision is becoming a reality. NEFI is gaining traction across prescribers, payers, and patients, which we will talk about during this presentation. Our momentum is reflected in the continued quarter-over-quarter growth in the U.S. net products revenue for NEFI. In Q2, we achieved $12.8 million in net product revenue, in part driven by the availability of our one milligram pediatric dose starting in May and steady traction we have made with payers. With 93% commercial coverage today, NEFI is accessible to the vast majority of patients with commercial insurance. Perhaps more importantly, this momentum has translated into strong and accelerating growth in NEFI prescriptions, a clear indicator of demand and commercial execution. From the end of the first quarter to the end of the second quarter of 2025, we saw an increase of 180% in weekly two-pack unit volume, which was in line with our internal expectations and consistent with analysts' forecasts. This growth is particularly encouraging as it comes before we have realized the full effects of three key important drivers. First, the rollout of our national DTC campaign, which started with targeted advertising in early June and was followed by an expansion to linear TV in July. Second, our U.S. pediatric co-promotion with ALK, which was fully deployed in late June. And third, the peak prescribing season of late summer and early fall as parents and children head back to school. As such, we expect to see even greater growth in Nephi prescriptions in the third and fourth quarters of this year. Beyond our U.S. commercialization, our partners are executing well to establish Nephi as a global brand. In June, AOK successfully launched UrNephi in Germany, the first country outside the United States to have commercial access to intranasal epinephrine. In July, UrNephi was approved in the United Kingdom. which is the largest market outside the U.S. for epinephrine auto-injector sales. Looking ahead, we expect additional regulatory decisions on NEFI in Canada, Australia, and Japan by the end of 2025, and in China by the first half of 2026, followed by commercial rollouts starting in the first half of next year. We also expect approval of the 1 milligram pediatric dose by the European Medical Agency in the first half of 2026, which would trigger another $5 million milestone payment from AOK. Beyond our first approved indication, we're expanding the reach of our intranasal epinephrine technology with the initiation of a randomized controlled phase 2B clinical trial in chronic spontaneous urticaria, a life-altering condition that affects millions of people. This study is underway with sites in the U.S. and Europe, and we anticipate top line data in the first half of 2026. Let me now turn the call over to Eric to review our U.S. commercial performance in more detail.