ARS Pharmaceuticals, Inc.

Good day, and welcome to the ARS Pharmaceuticals third quarter 2024 conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would now like to turn the call over to Alex Charles of Investor Relations. Please go ahead.

Good morning, and thank you for joining. With me on the call today are Richard Lowenthal, co-founder, president, and CEO of ARS, Eric Karras, our chief commercial officer, Kathy Scott, our CFO, and Justin Chokmah, our chief business officer. Earlier today, we issued a press release detailing our third quarter 2024 results and recent business highlights, which can be found on our website at ars-pharma.com. For today's call, Rich will provide an overview of our recent corporate developments. Eric will provide an update on our NEFI commercialization efforts. Kathy will provide a brief overview of our financial results, and the full team will join us for Q&A. During today's call, we'll be making forward-looking statements based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please see the risk factors in our SEC filings for additional details. Now, let me turn the call over to Rich.

Thank you, Alex, and thank you to everybody dialing in today. The last several months have been transformational for ARS Pharmaceuticals, with the approval of NEFI 2 milligrams in both the United States and Europe as the first and only needle-free epinephrine product for the treatment of allergic reactions, including anaphylaxis in adults and children who weigh 30 kilograms or greater. Nephi is dosed as a single two milligram spray in either nostril as soon as symptoms are recognized. A second dose can be administered in the same nostril as the first dose starting after five minutes in the absence of clinical improvement or deterioration. As seen in the U.S. FDA prescribing information, Nephi has no contraindications and no box warnings. There are about 20 million patients in the United States diagnosed with a recent history of severe allergic reactions who are actively managed by healthcare providers. All of these patients are in need of a safe, effective, easy to use, and easy to carry needle-free epinephrine treatment that they can use quickly and comfortably at the first signs of symptoms of the reaction. Early administration of epinephrine can lead to a better clinical outcome and improvements in daily living for patients and their caregivers, and importantly, peace of mind. Our U.S. launch efforts are underway, and we are very proud of the progress made thus far. Eric will provide a summary of our initial launch progress, which we expect to continue to ramp up through the year end 2024 and into 2025. Nephi became available for shipment from BlinkRx on September 23rd. and our US Salesforce was deployed in early October, which was also when NEFI was made available more broadly at retail pharmacies. We are greatly encouraged by the strong support and enthusiasm from patients, caregivers, and advocates, as well as positive feedback from our discussions with payers and the early interest shown by the medical community. This includes notable enthusiasm from pediatricians at the recent American Academy of Pediatrics meeting where they expressed excitement about the potential for a needle-free treatment option for smaller children in the near future. On that note, in September, we submitted a supplemental new drug application for NEFI 1 milligram for the treatment of type 1 allergic reactions, including anaphylaxis in children who weigh only 15 to 30 kilograms or 33 to 66 pounds. We just recently heard from FDA that this SNDA has been accepted for priority review with a BDUFA action date of March 6, 2025. In addition, we are amending our EU pediatric investigational plan to adjust timelines for the post-approval commitments in Europe and plan to file for European approval for the one milligram in early 2025. In Europe, we are very excited to have announced on Monday, November 11th, a strategic licensing agreement with ALK, a leading allergy-focused company with capability in 46 countries worldwide. ALK has licensed marketing rights for NEFI for Europe, Canada, and certain geographic regions outside the United States, China, Japan, Australia, and New Zealand. As a partner, we believe ALK has significant capabilities to work with ARS in both the conversion of the existing epinephrine autoinjector market, but also expanding the market to those severe allergy patients that are not currently protected with a community-used epinephrine product. Finally, the cash infusion of $145 million with 10 million short-term milestones gives ARS a healthy cash position of close to $350 million and puts us in a very strong position to accelerate our launch efforts for NEFI in the United States. In addition, regulatory submission for approval in Australia has been filed by our partners at CSL, and our partners in Asia are on track to complete regulatory submissions in both China and Japan in November. Shortly after that, in December, ARS plans to file on behalf of our partner ALK in the United Kingdom and Canada. We are rapidly expanding around the world based on significant demand for NEFI, with additional regulatory filings anticipated in 2025 to further expand its global reach. Our mission is to make sure that every person who needs NEFI can have access to it shortly. I recently had the privilege of attending the American College of Allergy, Asthma, and Immunology, or ACAI, meeting in Boston. There I had the chance to connect with numerous top allergists and healthcare providers and it was inspiring to hear their excitement about NEFI entering the market. Many shared positive feedback on its product profile and differentiation as highlighted on the product labeling. It was also rewarding to learn that patients in their offices are already asking for NEFI by name. We were also very proud to have been able to assist during a critical time of need following the recent Hurricane Helena in North Carolina. Nephi was approved and available just in time for that disaster. And thanks to its high temperature stability, we were able to supply 1,700 prescriptions of Nephi to the United Way of North Carolina for emergency first responders who needed it most and patients who lost their epinephrine product in the storm. I'm extremely impressed with our team's engagement with the allergy community so far, and I'm confident they'll continue working diligently to connect with healthcare providers and other key stakeholders Let me pass the call over to Eric to walk through early launch successes.