ARS Pharmaceuticals, Inc.

Good day and welcome to ARS Pharmaceuticals' fourth quarter and full year 2024 Financial Results Conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. Instructions will be provided at that time. As a reminder, this call is being recorded. I would now like to turn the call over to Justin Chokmah, Chief Business Officer. Please go ahead. Good morning.

With me today are Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, Eric Corraz, our Chief Commercial Officer, and Kathy Scott, our CFO. Earlier today, we issued a press release outlining our fourth quarter and full year 2024 results, along with recent business highlights. You can find this press release on our website at ars-pharma.com. Our call today will proceed as follows. Rich will provide an overview of our corporate progress and key development and insights into the NEPI launch. Eric will discuss NEPI's ongoing and planned commercialization efforts in the U.S. and our market strategy. Kathy will then provide a financial overview, after which we will open the call for questions. Before we begin, please note that today's discussion includes forward-looking statements based on our current expectations. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our earnings and reliefs issued today for further details and a discussion of risks. With that, I'll turn the call over to Rich.

Thank you, Justin, and thank you to everyone dialing in today. The past six months have been extremely productive for ARS. Since September, we have successfully launched NEFI 2 milligrams in the United States and secured FDA approval for the 1 milligram NEFI dose for patients weighing 15 kilograms to less than 30 kilograms. The population of children at this lower weight range that will use NEFI 1 milligram represents 23% of the current auto-injector market. ARS has also made significant strides in payer coverage. with over 51% commercially insured able to get NEFI without a prior authorization as of April 1st. And we anticipate over 80% without prior authorization by early this summer with the addition of NEFI to the Caremark formulary. Our commercial execution has established a strong foundation of healthcare provider awareness for NEFI as a compelling alternative to traditional epinephrine autoinjectors. providing patients with a needle-free, portable, and highly effective option for severe allergic reactions, including anaphylaxis. The U.S. epinephrine market represents a $3 billion in the annual net sales near-term addressable opportunity among 6.5 million patients prescribed epinephrine in the last three years, with an additional expansion opportunity among untreated patients of over $7 billion in annual net sales, covering It estimated 20 million patients that have been diagnosed with severe allergic reactions based on claims data. However, only 3.2 million patients consistently fill their autoinjector prescriptions, leaving a vast population without protection. NEFI directly addresses this gap by eliminating barriers such as the needle anxiety and portability challenges. Just a few weeks ago at the 2025 American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting, we showcased nine presentations on the continuously growing body of clinical evidence demonstrating the therapeutic value of NEFI to healthcare providers. Notably, among the presentations at the Quad AI meeting, a study in Japanese patients experiencing anaphylaxis symptoms after oral food challenge found that patients receiving NEFI experienced low symptom scores within 10 minutes compared to traditional intramuscular injection. A separate set of clinical studies in China reinforced the bracketed pharmacokinetics and pharmacodynamic profile of NEFI in persons with pure Chinese ethnicity, demonstrating its efficacy and safety under a variety of conditions, including self-administration, allergic rhinitis, infectious rhinitis, and allergy challenges and repeat dosing. An additional analysis confirmed that NEFI is safe and achieves effective exposures of epinephrine for patients four years of age and older and weighing 15 kilograms to less than 30 kilograms. I'm proud of these data we presented at the Quad AI meeting as it showcases NEFI's extensive and rigorous clinical development program. Nephe remains the only approved product to have generated anaphylaxis efficacy data in a clinical study, to have met the bracketing criteria established by FDA for approval of all key pharmacokinetic parameters to ensure safety and efficacy, and to have data demonstrating that it is well-tolerated in children down to 15 kilograms body weight, who account for almost half of the patients prescribed epinephrine. This and other extensive clinical data we have previously presented on NEFI's profile has now been supported by the growing real-world data of treating anaphylactic reactions from our NEFI experience program. The data from the NEFI experience program to date is numerically better than that historically reported with epinephrine injections. We plan to share additional details of this survey of our NEFI experience program once we have completed the survey and plan to repeat this several times during the program as it progresses with over 2,500 clinicians having NEFI for oral food challenges and immunotherapy treatments. At Quad AI, hundreds of physicians shared with us many of their positive success stories of treating patients with NEFI, including cases where patients had been rescued by NEFI from even having very severe anaphylactic reactions and being unconscious. Physicians are clearly and enthusiastically communicating to us that they believe that NEFI represents a new standard of care. We have established a strong initial commercial trajectory in the U.S. to ultimately deliver on this expectation and establish NEFI as the new standard of care. Since the initial launch in September of 2024, NEFI generated $7.3 million in net product revenue in the United States reflecting a strong early adoption since it became available in the fourth quarter, and strong breadth of early prescribing with thousands of healthcare providers prescribing NEFI reflecting the allergy community's confidence in NEFI as an alternative treatment. That said, as you can see in the IQVIA prescription data, we are still on the early part of the S curve of what we anticipate to go into a multi-billion dollar blockbuster peak sales trajectory. We anticipate a significant inflection in both the depth as well as the breadth of healthcare provider prescribing later this year as the headwinds from the need for prior authorization requests diminish. Healthcare providers consistently tell us that the current levels of NEFI prescribing represent only a fraction of their intended use of the product in the future. In fact, one leading allergist stated that he intends to switch all of his 4,000 patients. but our data shows that this doctor is only prescribed to about 1% of their patients to date, given the need for these prior authorizations to get approval. A key learning in the NEFI launch is the unique administrative barrier that prior authorizations pose for NEFI due to the large volume of epinephrine eligible patients, as well as the acute nature of this disease, This results in the need for a very large number of prior authorizations to get a significant revenue, given each prior authorization translates to an average of 1.3 prescriptions per patient to date. As a result, healthcare providers only have bandwidth to prescribe very selectively due to the cumulative time required to prepare prior authorizations, even with simplified forms and ARS facilitation through BlinkRx. Based on this feedback from hundreds of prescribers, including most recently at the Quad AI meeting, we expect to see a tipping point in the NEFI trajectory as we attain our payer coverage goals early this summer and make prescribing more seamless for physicians. Our payer engagement strategy has already yielded multiple favorable coverage decisions, including a cent. the group purchasing organization for Express Scripts, one of the three largest pharmacy benefit managers in the United States, who put NEFI on formulary within 10 weeks of launch. In the last month, we also have signed contracts and provided patients with unrestricted access to NEFI with two other group purchasing organizations, MSR and Zinc, at terms that preserve our greater than 50% gross to net yield. MSR signed an agreement in February adding NEFI to their formulary, which now gives patients who have OptumRx access without any restrictions. As of April 1st, UnitedHealthcare will also add NEFI to their formulary with unrestricted coverage under the MSR agreement. Just the past few days, we also obtained agreement and coverage with Zinc, which provides access to the largest payer in the United States, CVS Caremark, as well as Anthem, Aetna, and several other insurers. We anticipate being on formulary for CVS Caremark, Anthem, Aetna, and others by July 1st in time for the summer peak prescribing season for children. Therefore, we remain on track for 80% unrestricted commercial coverage by the summer of this year. We have also made progress on Medicaid with bellwether states such as Texas, Alabama, and Montana adding NEFI to their formularies without prior authorization. and other states are expected to follow suit in the coming months leading into the summer prescribing season for children. By the summer, we anticipate physicians to freely start writing NEFI for their patients without being deterred by the administrative workload of prior authorizations. This will be in time for the back-to-school season driven by the pediatric population, And we'll also be supported by the fact that we will have 1 milligram NEFI in the marketplace by May 2025, which represents 23% of all prescriptions as mentioned earlier. And having ended this year with over $314 million in cash or cash equivalents, we are in a strong financial position to accelerate adaptation and awareness during the back to school season, including an extensive direct to consumer campaign we anticipate launching in May of 2025. In parallel, we are also on track to have a global commercialization footprint with NEFI within one year from now. As a reminder, your NEFI, the equivalent of NEFI in Europe, is approved in the European Union. Our UK regulatory submission is under review, with a decision expected by May 2025, and our partner, ALK Abello, is preparing for commercial launches in Germany and UK by this summer. Regulatory submissions are also completed in Canada, China, Japan, and Australia, with decisions in Canada, China, and Japan anticipated by year-end 2025. As we look ahead, physicians and patients' demand is clear for NEFI. We are also getting favorable payer formulary coverage, which is now just a function of time with the three major GPOs signing agreements that are favorable and give us a 50% gross to net for better. We are also accelerating our marketing and investments in direct-to-consumer advertising prior to the back-to-school peak prescribing season. We expect to see significantly broader and deeper adaptation of NEFI across the board through conversion of the existing epinephrine users, reactivation of patients who previously avoided treatment due to their fear of injection, and bringing NEFI to those who didn't have a prescription or diagnosis in the past. Let me turn the call over to Eric to walk through our commercial highlights and plans for increasing adoption and use of NEFI in 2025.