Good day and welcome to ARS Pharmaceuticals' fourth quarter and full year 2024 financial results conference call. At this time, all participants are on 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 Chakma, Chief Business Officer. Please go ahead. Good morning. With me today are Richard Lowenthal, Co-founder, President, and CEO of ARS Pharmaceuticals; Eric Karas, our Chief Commercial Officer; and Kathleen 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 Neffy launch. Eric will discuss Neffy's ongoing and planned commercialization efforts in the U.S. and our market strategy. Kathleen 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 release 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 Neffy 2 milligrams in the United States and secured FDA approval for the 1 milligram Neffy dose for patients weighing 15 kilograms to less than 30 kilograms. The population of children at this lower weight range that will use Neffy 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 Neffy without a prior authorization as of April 1, and we anticipate over 80% without prior authorization by early this summer, with the addition of Neffy to the Caremark formulary. Our commercial execution has established a strong foundation of healthcare provider awareness for Neffy as a compelling alternative to traditional epinephrine auto-injectors, 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 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 an 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 auto-injector prescriptions, leaving a vast population without protection. Neffy 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 Neffy to healthcare providers. Notably, among the presentations at the AAAAI meeting, a study in Japanese patients experiencing anaphylaxis symptoms after oral food challenge found that patients receiving Neffy 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 Neffy 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 Neffy 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 AAAAI meeting, as it showcases Neffy's extensive and rigorous clinical development program. Neffy 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 Neffy's profile has now been supported by the growing real-world data of treating anaphylactic reactions from our Neffy Experience Program. The data from the Neffy 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 Neffy 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 Neffy for oral food challenges and immunotherapy treatments. At AAAAI, hundreds of physicians shared with us many of their positive success stories of treating patients with Neffy, including cases where patients had been rescued by Neffy from even having very severe anaphylactic reactions and being unconscious. Physicians are clearly and enthusiastically communicating to us that they believe that Neffy 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 Neffy as the new standard of care. Since the initial launch in September of 2024, Neffy 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 Neffy, reflecting the allergy community's confidence in Neffy 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 and 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 Neffy 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 has 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 Neffy launch is the unique administrative barrier that prior authorizations pose for Neffy 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 AAAAI meeting, we expect to see a tipping point in the Neffy 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 Ascent, the group purchasing organization for Express Scripts, one of the three largest pharmacy benefit managers in the United States, who put Neffy on formulary within 10 weeks of launch. In the last month, we also have signed contracts and provided patients with unrestricted access to Neffy with two other group purchasing organizations, Emisar and Zinc, at terms that preserve our greater than 50% gross-to-net yield. Emisar signed an agreement in February adding Neffy to their formulary, which now gives patients who have OptumRx access without any restrictions. As of April 1, UnitedHealthcare will also add Neffy to their formulary with unrestricted coverage under the Emisar 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 1 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 Neffy to their formularies without prior authorization. Other states are expected to follow suit in the coming months leading into the summer prescribing season for children. By this summer, we anticipate physicians to freely start writing Neffy 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 will also be supported by the fact that we will have 1 milligram Neffy in the marketplace by May 2025, which represents 23% of all prescriptions, as mentioned earlier. Having ended this year with over $314 million in cash or cash equivalent, 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 Neffy within one year from now. As a reminder, EURneffy, the equivalent of Neffy in Europe, is approved in the European Union. Our U.K. regulatory submission is under review, with a decision expected by May 2025, and our partner, ALK-Abelló, is preparing for commercial launches in Germany and U.K. 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 Neffy. 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 or 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 Neffy 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 Neffy to those who did not 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 Neffy in 2025. Good morning, and thank you, Rich. As we've laid out previously, our Neffy commercial strategy is focused on three core areas: physician education and engagement to drive Neffy adoption and market share, payer coverage to ensure affordability and access to Neffy, and patient awareness and education to encourage adoption and prompt patients to ask their healthcare provider for Neffy. Our team is executing very well against all three of these. To date, our sales team has directly engaged with approximately 9,000 healthcare providers. Additionally, more than 4,000 healthcare providers have submitted Neffy prescriptions through BlinkRx by Neffy Connect. Importantly, approximately 81% of these prescriptions were submitted by physicians in the highest decile of allergists. These are physicians who represent the highest volume prescriptions in the U.S. At the recent AAAAI meeting, we met with over 1,000 physicians, and the feedback across the spectrum of stakeholders continues to reinforce the enthusiasm for a needle-free epinephrine treatment and the growing demand for Neffy. Among the physicians that the team engaged at the conference, the feedback regarding the product was overwhelmingly positive. Many HCPs who have used Neffy in a clinical setting as part of the Experience Program shared their experiences. One particularly influential physician, who is a thought leader amongst his peers, had his first experience with Neffy just two weeks before the conference. He was so impressed with the response, which appeared within a minute, that he shared his experience with his colleagues and nursing team. Allergists have reported great real-world success with response rates similar to or even better than those historically reported with epinephrine injection products. As of today, approximately 2,500 allergists have enrolled in our Neffy Experience Program. It allows for hands-on clinical use and real-world validation of the product. This participation represents over 80% of the healthcare professionals conducting allergy challenge studies, reflecting a strong interest in Neffy. Our commercial team is actively sharing this information with both Neffy Experience participants and healthcare professionals more broadly, which reinforces their confidence in Neffy's clinical profile backed by real-world response data. We have observed strong adoption by payers, with positive coverage decisions from major organizations such as Express Scripts, Cigna, OptumRx, Navitus Health, and TRICARE. The coverage enhances access to Neffy for millions of commercially insured patients across the nation. Furthermore, starting April 1, UnitedHealthcare will include Neffy as a covered treatment without a prior authorization. In addition, all three group purchasing organizations have signed contracts with us: Ascent in late Q4 of last year and Zinc and Emisar in the last few weeks. We expect downstream payers of these GPOs to adopt the negotiated terms and add Neffy to the formularies with unrestricted access. Payers recognize the added value that Neffy offers by lowering barriers to prompt epinephrine use, leading to better outcomes for patients and reduced healthcare costs. Our goal is for Neffy to achieve more than 60% commercial coverage by the end of the first quarter. Given our current position, we are confident in our ability to reach this target. We are actively engaging in discussions and contract negotiations with additional key payers and expect to achieve 80% commercial coverage by the early part of the third quarter. As commercial coverage increases, the product acquisition process is streamlined, allowing doctors to more easily send prescriptions directly to retail pharmacies such as CVS and Walgreens. For patients with commercial insurance, our copay assistance program has made Neffy more affordable. Most commercial patients only pay $25 for each prescription, which is lower than the average copay of $40 for a generic auto-injector. Our copay support is automatically applied at the point of sale, ensuring that Neffy is accessible to more patients. Switching gears, we are also proud of our Neffy in Schools program, which provides K through 12 schools with two cartons or four single-use doses of Neffy at no cost. This initiative aims to promote widespread adoption of the product in schools nationwide. To date, more than 5,000 nurses have participated in our educational sessions and are now advocates for Neffy. We greatly appreciate the collaboration with school nurses, who play a crucial role in safeguarding children by administering this easy-to-use needle-free epinephrine device in emergencies. As we look ahead, we are planning a large-scale direct-to-consumer advertising campaign starting in May. This is time for the peak prescribing season during the summer. This campaign will include connected television platforms such as Hulu, Netflix, and Prime, as well as linear TV focused on news and sports channels. In addition, we will utilize print and social media, incorporating influencer partnerships with a combination of broad and targeting advertising strategies. This initiative is crucial because our market research indicates that when a patient requests Neffy, physicians will prescribe it, provided there are no market access barriers. We also recognize that the epinephrine market has been highly responsive to promotional efforts in the past, and we have seen no meaningful promotion in the last decade. We are planning additional near-term commercial initiatives specifically aimed at the pediatric population, targeting both healthcare providers and caregivers. We plan to share more details about these initiatives in the coming weeks. The pediatric population significantly contributes to the summer peak in prescriptions observed in the market as schools prepare to reopen. We believe we are well-positioned to take advantage of this seasonal trend, especially since early adopters of Neffy are parents with children who are affected. The recent approval of the 1 milligram dose will allow us to access the entire school-age population. We also plan to continue collaborating with our advocacy partners running PSA campaigns, as well as other institutional partners, to create a total surround sound environment for Neffy. Finally, as the year progresses, we'll evaluate further expansion of our sales team by early 2026 to maximize healthcare provider engagement and drive market share. After spending several months on the front lines with our sales team and meeting with hundreds of prescribers, it has become clear that Neffy has a compelling clinical profile that resonates with both physicians and patients. This has been further validated by the successful treatment of patients with allergic reactions, as demonstrated in our Neffy Experience Program. All indications show that physicians are eager to prescribe Neffy more frequently, and we understand the steps needed to remove the obstacles they face. We are excited to unlock the demand for Neffy in the coming months by ensuring a more seamless insurance experience and driving patient demand through our comprehensive DTC campaign and our sales and marketing efforts. Let me now pass the call over to Kathy to talk through our financials. Thanks, Eric. We reported our Q4 and full year 2024 financial results in a press release this morning, and I'll walk through some of the highlights. In terms of sales, we're proud to have recorded $6.7 million in Neffy sales for the fourth quarter of 2024 and $7.3 million for the full year 2024 since our launch in late September. Of note, these revenues are slightly higher than the preliminary numbers that we announced mid-January. Before turning to our revenues, I'll take a minute to explain how we're treating the cash proceeds from our ALK licensing agreement that was signed in November 2024. As a reminder, we received a non-refundable upfront cash payment of $145 million from ALK. In Q4, only $73.5 million of that payment was included in our revenues. The remaining $71.5 million is treated as a liability on the balance sheet due to GAAP accounting treatment. Specifically, $69.4 million is treated as a financing liability, and $2.1 million is treated as a contract liability for future performance obligations. This GAAP accounting treatment is because of a specific term of our licensing agreement that we built in to maintain strategic optionality for the future. The agreement ensures that ARS has the option to repurchase rights for certain regions partnered out to ALK, which results in our not being able to account for a portion of the cash proceeds as revenue. While the business and economic intent is that of a licensing agreement, due to the open-ended flexibility of the reacquisition language, GAAP treats cash flows from these certain territories as a financing agreement that shows up on the balance sheet, impacting our reported revenue figures. To reiterate, there is no impact on the amount of the non-refundable cash proceeds received, and we have sole discretion in how they are used. Going forward, none of the financing liability from the ALK agreement that appears on the balance sheet as of December 31, 2024, will be included in revenue until the expiration of the ALK agreement. We expect to receive $5 million in cash proceeds from milestones under the ALK agreement in each of Q2 and Q4 2025. Approximately half of each $5 million payment will be recognized as GAAP revenue. The other half would not be recognized as GAAP revenue, but would be added to the financing liability on the balance sheet. Future royalty payments from ALK would be recognized as GAAP revenue if they are related to the territories that are not subject to the repurchase right. Royalty payments related to territories that are subject to the repurchase right would be capitalized and added to the financing liability on the balance sheet. To summarize our 2024 revenues, total revenue for the fourth quarter of 2024 was $86.6 million, which included $6.7 million in net product revenue from Neffy sales in the U.S., $73.5 million in collaboration revenue from ALK, $6 million in collaboration revenue from our licensing partner in Japan, and $0.4 million in revenue from supply agreements. Full year 2024 revenue totaled $89.1 million, reflecting $7.3 million in Neffy sales in the U.S., $81.5 million in collaboration revenue, and $0.4 million from supply agreements. The Q4 and full year 2024 revenues do not include the $71.5 million cash proceeds received from ALK that are required by GAAP to be recorded as a liability on the balance sheet. Turning to our expenses, R&D expenses for the fourth quarter and full year 2024 were $3 million and $19.6 million, respectively. These costs were primarily associated with the manufacturing of Neffy to support our U.S. commercial launch, along with certain other product development costs and personnel-related expenses. Our SG&A expenses for the fourth quarter and full year 2024 were $35.5 million and $71.7 million, respectively. These primarily reflect marketing expenses and personnel-related costs associated with the commercial launch of Neffy, as well as general operating expenses. We had net income of $49.9 million, or $0.51 per share basic, and $0.48 per share diluted for the fourth quarter. Net income was $8 million, or $0.08 per share basic and diluted for the full year 2024. In terms of our balance sheet and cash runway, we ended the year with $314 million in cash, cash equivalents, and short-term investments. At the time of FDA approval of Neffy 2 milligram in August 2024, we guided to an operating runway of at least three years, which budgeted an upfront fee of about $50 million for an ex-U.S. partnership. The ALK licensing agreement provided us with a significantly greater cash infusion of $145 million upfront and an additional $10 million in near-term regulatory and launch milestones expected to be attained in mid to late 2025. As such, the combination of the capital brought in from our ALK deal, along with our earlier-than-anticipated success in obtaining favorable coverage decisions from U.S. payers, has given us a lot of flexibility to further invest in the commercialization of Neffy while maintaining a strong balance sheet. Looking ahead, as Eric noted, we plan to accelerate our DTC investment beginning in May in order to take advantage of the back-to-school seasonality. We are projecting a DTC campaign spend of between $40 million and $50 million in 2025. In parallel, we are working to ensure availability of the 1 milligram Neffy dose for children four years or older starting in May. With this in mind, we anticipate operating expenses, excluding both cost of goods sold and stock-based compensation, will be approximately $200 million-$210 million for the full year 2025. With this forecast, we still expect to maintain a runway of at least three years based on our current operating plan. I'll hand the call over to Rich now to finish up. 2024 has set up 2025 to be a pivotal year of commercial execution for Neffy. Our primary focus is accelerating adoption of Neffy and expanding global market access and advancing our intranasal epinephrine technology, with the plan to start Phase 2 in urticaria, as well as our allergy challenge clinic registry study in the next few weeks. The early enthusiasm from physicians, payers, and patients reinforces our confidence in Neffy's potential to become a new standard of care in emergency allergy treatment. I'd like to thank the entire ARS team for their dedication in making this launch a success. We look forward to continued momentum in 2025 and beyond. With that, let's open up the call for questions. Thank you. We will now begin the question and answer session. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Ryan Deschner with Raymond James. Your line is open. Hi, good morning. Thanks for the question, and congrats on the progress. I think you mentioned that Neffy 1 milligram will be available starting in May. A lot of KOLs we've spoken to have said this is the big source of demand even currently. How are you looking at the ramp for this format relative to what we've seen with the 2 mg product? I have a follow-up. Yeah, we believe it's additive. It's about 23% of the market. However, it's probably more than that for the impact on the sales ramp of Neffy. As we discussed, the adoption we're seeing right now is heavily weighted towards children. Obviously, adding younger children, which obviously parents have more of an issue with injecting, actually should be very beNeffycial. As we said, we expect it to be weighted. In 2024, it was 23% of the prescriptions for epinephrine injections. We think the 23 will have a significant impact on our sales ramp. Sorry, the 1 milligram, excuse me, the 23% would have a significant impact. Got it. Just one more, wondering if you could give us any more detail on the progress toward the 80% access goal, which I think was more toward the end of the third quarter. It sounds like it's evolving. What proportion of Neffy sales do you expect to come from public programs like Medicaid? Thank you. Yeah, I'll speak a little bit to that. Eric, if there's anything I missed, you can add in. At this point, we're at about, as of April 1, UnitedHealthcare came to agreement with us, and we'll put it on unrestricted access on April 1. As of April 1, we'll be at about 51% of commercial patients will have access without a prior authorization. Now, it's a little over 60% total, but we actually focus on the ones that don't need the prior authorization because that's the, what we're realizing is the major barrier to prescribing Neffy for a lot of physicians. Even those that are very favorable, they honestly tell us they only have so many hours in a day and weekends to write prior authorization. It is a big headwind. With that also said, we just signed an agreement really just within the last week with Zinc. Zinc represents Caremark, Aetna, Anthem, and a number of other insurers, which is more than 25% of the commercially insured market. Unfortunately, or for whatever reason, I can't tell you, but Caremark typically only puts things on formulary either January 1 or July 1. We do currently expect them to put Neffy on formulary by July 1. They do make exceptions. It could go sooner, but we don't know that yet. If Caremark goes on formulary July 1, we also expect Aetna and Anthem to be on formulary. By formulary, I mean unrestricted access, right? No prior authorization required because they're already approving prior authorizations fairly readily. We do expect them to have unrestricted access by July 1 or sooner. That would bring us very close to that 80% mark. Certainly, if you count all coverage, but even just counting unrestricted access, I think we'd be close to the 80% mark by July 1. We think that's very encouraging going into the summer season on top of our DTC campaign and other information we'll be putting out to make doctors more and more comfortable with the use of Neffy. We think we'll all come together for this summer period and really hopefully drive sales over the summer. Thanks for the color. Appreciate it. One moment for our next question. Our next question comes from Alexa Diemer with Cantor Fitzgerald. Your line is open. Good morning, everyone. This is Alexa Diemer on for Josh Schimmer, and congrats to the ARS Pharmaceuticals team on another great year. I wanted to ask what percentage of the epinephrine market is direct-to-patients in comparison to the broader entities like airlines and schools? Okay. Currently, very little is being sold outside of the retail market. Almost all of our sales are retail. We are working with the two largest kit manufacturers for airlines who do want to replace other epinephrine products in the kits. Obviously, airlines have to opt in, but there are a lot of advantages to Neffy between the ease of use, the lack of the needle, which reduces liability for the airlines, as well as the temperature excursion data, the high temperature data, which is important in an airplane. Very little, and Eric, you can chime in here. I do not think much, if any, of our revenue is coming from outside of retail. We expect that to grow over time. Initially, it takes time for that to happen. For example, the kit manufacturers did not want to put Neffy in the kits until the 1 milligram was available. They are waiting because they need both doses. At that point, we expect that to start to pick up over time. Not immediately, because they are not going to go throw away all their kits or replace all their epinephrine in the kits. They are going to do it over time as it expires. Eric, do you want to add anything into that? Rich, I'll just add that when we look at our forecasting, it is really focused on the retail market. As Rich mentioned, kind of this public interest market of airlines. You can think about hotels, restaurants, law enforcement, emergency rescue. That is not included. As time goes on in terms of education and awareness and them getting funding, we do have an opportunity in that channel. Just one point back to Ryan's question too, just people may be thinking this. The 1 milligram is also included in all of our payer contracts. Once that's available, there's no issues with a doctor writing the 1 milligram in addition to the 2 milligram. I'll just add one more point to that because one of the things you need in a retail market is to find a way to make or to make it easier for some of these organizations, such as restaurants, to purchase Neffy, right? You can imagine a very well-off restaurant can easily afford to buy a couple of boxes of Neffy. Most restaurants run on fairly tight margins, so buying Neffy to have in the restaurant is perhaps a hurdle. One of our largest advocacy groups actually came up with a great idea and is working on this independently of us because they want to see Neffy in the restaurants, and they believe that without the needle, the liability again becomes much better so that the good Samaritan using Neffy can't hurt themselves versus an auto-injector. They're actually negotiating with several of the largest insurance companies, and I've mentioned this to a few analysts already, to give a discount on their insurance if they have Neffy in the restaurant or epinephrine in general. We think that's a brilliant idea, actually, because that would potentially pay for the Neffy for the restaurant by giving a discount on their insurance if they actually have the epinephrine in the restaurant. Those kind of things are all happening. Again, we'll take some time before we start to realize significant revenue from those types of opportunities. Awesome. Thank you. Congrats again. One moment for our next question. Our next question comes from Louise Chen with Scotiabank. Your line is open. Hi, congratulations on all the progress this quarter, and thank you for taking my questions. I had a few for you. First question I wanted to ask you was, how long does prior authorization for those payers that require you to do it usually last for? Does it have to be renewed? The second question I had was, do you have any data that talks about that upside expansion opportunity for you and how many of those patients you're actually picking up from there, those that are untreated or previously diagnosed? Last question is, I saw some headlines on the potential for epinephrine to go over the counter. I do not know if you have any thoughts on if that were to ever happen, what that would mean for you. Thank you. Okay. Could you just repeat the questions one at a time? First question, sorry, just to make it clear. Yeah, yeah, sure. Yeah, sure. I wanted to ask you with respect to prior authorization for the payers that require you to do it, how long does this usually last for? Does it have to be renewed at some point? I think, and Eric, you can add into this, but I believe that they need a prior authorization. I mean, again, the nature of this is a little unusual. You might only get one or two or three prescriptions a year, right? They're going to get a prior authorization for that prescription. Some of them are for one, some two. We've seen three prescriptions go through or three boxes in one prescription, I should say, three units pretty readily. I believe they would probably need that prior authorization each time. That's a huge burden. If you think about the revenue, on average, right now, we're seeing 1.3 units per prescription. We believe that will go up significantly because a lot of those are cash pays, where they're just buying one now, and they'll get more once it's on unrestricted coverage, once their insurance company is covering it. If you think about it, it's only a little more than $500 in revenue to us, net revenue. Each prior authorization accounts for a very small net revenue. That is why we believe in this category, it's a major hurdle for the doctors. Do you want to add anything to that, Eric? Yeah, I would just say it's a mix. It depends on the insurer, as Rich mentioned. Some will require it every single time. Others may be a little bit longer. I also think it's important, as we mentioned in our presentation, that we are on track to hit that 80% of coverage in commercial. When we say that, that's coverage with no PA. All of our contracts that we're putting in place with the GPOs, with the PBMs, again, we're not paying any rebates if there's any type of step edit or prior authorization. We are really confident that, again, we're lowering the barriers in time here for physicians to write this product without a PA. Okay. If you could just repeat your second question again. Yeah, sure. Okay. Wanted to ask you, for patients that were previously diagnosed but untreated with traditional epinephrine, how many of them have chosen to take your product? Just trying to assess the expansion opportunity and how that's progressing for you. Eric, do you have that information? We haven't broken out and done any claims analysis. We have plans to do that in the middle part of the year here. From an opportunity perspective, as we've shared, there's 3.2 million patients that have current treatment, and then you're looking at another 16.5 million that are diagnosed without treatment. Within that group, we know over the last couple of years, there's 3.3 million patients that have been prescribed epinephrine. About a third of them have filled, but they haven't refilled. There is a significant opportunity there to reengage those patients. When we talk to physicians, when we talk to patients in that group, the major reasons why they did not refill or fill initially is because of the needle size, portability, and affordability as well. When you look at our programs in commercial, again, if they are covered, $25 for the prescription. Even if they get more than one carton, we only charge one copay, but we are able to, again, get reimbursed on two cartons or three cartons. The average copay for a needle injector is about $40. I think we are removing a lot of the challenges in terms of a needle-free, easy-to-use, portable option. We do see a very significant opportunity to reengage this population, whether it is through the physician or our DTC efforts that we will launch in May. Does that help? Yeah. Can I ask one more quick question? Yep. Very good. Thank you. The opportunity for epinephrine to go over the counter, what would that mean for you? Yeah. It's been brought up to us multiple times, including by big pharma companies. Of course, we know the inhaled epinephrine is over the counter, but it's not systemic, and it's for asthma. The two criteria for over the counter, obviously, are first safety. We believe Neffy is very safe, especially with only two doses. You can overdose on epinephrine, so that is a big risk. FDA has raised significant concerns about levels above that observed with two EpiPens. That's been a big significant discussion for years and years and years that they just don't know the safety in real-world patients with levels above that. People that might take more than two doses of Neffy would be a concern to FDA. The other criteria is self-diagnosis. You got to be able to self-diagnose that you have the disease. There are a lot of causes of symptoms similar to food allergies that may or may not be an actual food or venom allergy. FDA would also have to get over that barrier of the ability of people to self-diagnose. While it is a discussion and would be interesting, I think it is a difficult hurdle for this type of product, just the profile for FDA. I would not expect it to go to DC. Certainly, in the near future, I would not expect that to happen. Thank you. One moment for our next question. Our next question comes from Roanna Ruiz with Leerink Partners. Your line is open. Hey, morning, everyone. I was curious, what are you hoping to learn from the challenge clinic registry study for Neffy that's starting in April and around how long will that run for? As you gather this data, would you present it in sort of a rolling basis this year at medical meetings or publications? Yeah. First of all, this is going to be the largest randomized controlled study ever done with epinephrine, period. There's never been a study like this done. Now that we're approved, FDA believes it's feasible. We believe it's feasible. It will be 600 people treated, 400 on Neffy, 200 on IM injection. Again, it will be randomized and partially blinded. By partial, I mean it's blinded up to the time the physician decides to give a dose of epinephrine. They won't know what the treatment is up to that point. The second dose would not be blinded because, of course, they know what they gave the first time. It would have to be the same product the second time if they need a second dose. This is going to be a very significant study. FDA's primary interest is safety. Again, as I mentioned, all of our clinical trials are in healthy people in a clinic, not having a reaction. FDA is very interested in seeing real-world data of all comers. Basically, this study will be anyone they're going to give oral food challenge to is eligible to enroll. That That would normally get epinephrine if they have a reaction. It is a really real-world study where you're going to get patients with asthma, with all sorts of other concomitant meds. Nothing is barred in this study. We'll get a really good sense of the safety of Neffy and also of injection. Even prior injection, I don't think we have a super good sense of that in a clinical environment like this where you're really recording things that are not just spontaneously reported. That's the nature of the study. It's going to be really, it's going to be an amazing study. We will do an interim analysis. I don't think we'll do multiple rolling ones because that's just not normally done. We probably will do an interim analysis so that at least preliminary data will be presented probably at the next AAAAI meeting. Then we'll present the full data. We will be looking at clinical outcomes as well, but those are secondaries because FDA did really focus on safety, that they wanted to understand the safety of Neffy, have better data on the safety of Neffy. We understand its side effects are very mild and very infrequent. Nonetheless, they want to see in patients that actually have a reaction and are on all their concomitant meds or have all their other concomitant conditions that you typically see in this population. That is really the main focus of the study. We will probably do an interim analysis, Roanna. That is helpful as well. Yep. Got it. Interesting. I wanted to follow up. I thought your KOL feedNback that you mentioned earlier was really interesting in terms of physicians that want to switch all of their patients to Neffy or possibly majority. Do you have a sense of the proportion of physicians out there that you're detailing that have this interest? I think it's mixed. I think of some we talked to at AAAAI, which are really the top-tier physicians, to be very honest, because they're the ones that are going to the meetings and educating themselves. I've had a number of conversations myself with a lot of these. One major one told me that he just doesn't have, he can't spend all evening and weekends writing PAs, so prior authorization. He's kind of limited. He's picking and choosing. He would switch almost everybody, and he thinks almost all of his patients would prefer Neffy. He also noted that in his region, he's a major advisor to pediatricians and general practitioners. He had thrown out that he advises about 100 pediatricians and a couple hundred general practitioners that have patients that contact him with questions. He said none of them will write PAs. They just won't do it. Allergists are more flexible to write these prior authorizations where pediatricians just probably have less time. I don't know if they're not as equipped in their clinics to write prior authorizations and manage it. He said they just won't do it until that barrier clears. Even they're contacting him about Neffy and wanting to prescribe, especially, again, to the children are a primary focus of a lot of these doctors right now. We think it's pretty prevalent. There are still a few that are waiting to see some real-world data. We're collecting real-world data from our Neffy experience that looks spectacular right now. Once we get to a large enough, and right now, we can talk about it a ANCHlittle bit if you want, but we're at about 758 patients treated that have been reported from 478 doctors. The data is coming in really like it's working at least as well as injection, possibly even better. Nonetheless, once we get to maybe a couple thousand, we might do a publication, basically a letter to the editor of one of the major publications to give some data. I think that's what a lot of them are waiting for. They're waiting to see, especially the less, let's say, academic, scientific doctors that understand the data well. The other ones, they're like, "Well, okay, let me see it used in a bunch of patients, and it's working well, and then I'll prescribe." They all agree this is a much better profile, much better product than injection for their patients. A lot of them still have that hesitation. That is one of the other two or three things we're focused on, really that unrestricted access, making the doctors comfortable and getting real-world data for them that it's really working equal to injection. The third is raising awareness among the patients and caregivers that Neffy is available, and they can go get it unrestricted without complications or high fees. That is going to be a big initiative as well. That is why we're aligning our DTC campaign with that access occurring. Some people say north of 50% is already good enough to start driving patients into the doctors. We're actually going to start that process when we're hopefully closer to the 80% mark so that people will get it very easily and without high copays. Makes sense. Thanks a lot. One moment for our next question. Our next question comes from Lachlan Hanbury-Brown with William Blair. Your line is open. Hey, guys. Thanks for taking the questions. I guess the first one is just, can you talk about the system that you have to go back to doctors or patients who were written a script and it wasn't approved once you get coverage with their insurer? And sort of the system you have and maybe what you've seen from that so far as you've won some formulary. Yeah. Two different things I would separate. If it's through BlinkRx, our online pharmacy, then BlinkRx is obviously keeping record of all patients who were denied a prior authorization or who even filed a prior authorization. We have all that data and their contact information because they went through BlinkRx. As insurers are added to coverage and we get unrestricted coverage with new insurers, they can go back and inform the patient as well as the doctor that that patient is now covered and can go back and get Neffy without a prior authorization. That is one thing I think Eric's team is doing quite effectively. The other is a little harder to deal with if it was a script written through a pharmacy. Of course, even if we have the cash pay in place or a patient goes and they do not have that copay assistance, you could have a lot of people walk away from the script that we do not want. We want them to go to the pharmacy and have that $25 copay. In that regard, we are doing a couple of things. The sales force is really tasked with informing the doctors that their patients are now covered for, let's say, United as of April 1, right? Another couple of weeks, if you are a UnitedHealthcare patient, which is about 8% of the United States commercial insurance, you can now go back and get that script again. If the script is still valid, just go back to the pharmacy and get Neffy and not have to have the prior authorization. On top of that, we also do not want patients to walk away from a copay. If they have, with United, if they have an $80 copay, just throwing out a number just as an example. You have an $80 copay for Neffy with United, and you do not want to pay $80, but you would easily pay $25. You have to have our coupon from our website from your smartphone to give to the pharmacist. We are now working very hard with both CVS and RelayHealth to sign agreements to preload that card. When patients and caregivers go to the pharmacy, it will be automatic that they will not have to have the coupon. If they forgot the coupon. Surprisingly, even somebody I know who has used Neffy multiple times already, she has a lot of different allergies, and she is a very smart person. She actually paid $200 for Neffy, and she had authorization. She had prior authorization approved for insurance coverage. I was shocked. I said, "Didn't she use the coupon?" She said, "Oh." I'm like, "We don't want that because she obviously could afford it. She didn't think anything of $200." To a lot of people, $200 is a barrier, and we'll walk away from the script. We're trying to get that done as well to make sure that it's seamless, meaning you get your script from the doctor, you go to the local pharmacy, you hand the script to the pharmacy, or it's sent electronically, of course, these days, so you don't actually have a physical script. You go into the pharmacy, and they just say, "Your copay is $25," and you walk away happy. That is really what we're trying to get to, to make that as seamless as possible for the vast majority of the population as quickly as possible, especially going into this summer. Great. Thanks. I mean, can you comment on sort of coverage that you've won so far? Have you seen many of those scripts, for example, the ones through BlinkRx, go back and get filled? Or those patients, maybe when the initial script is denied, do they just get a script for an auto-injector? Yeah. I will refer to Eric on that one. Eric, do you have any information on that as to when BlinkRx goes back after coverage? I do not know. Yeah. We are seeing a percentage of those patients convert. We have a protocol in place, as Rich mentioned. Once we get coverage, and we've been doing this over the last couple of weeks, we're reengaging those patients. A portion of those patients opted to go to the cash prescription. The other ones, we're getting a nice amount of them kind of coming back and saying, "Okay, hey, great. Now that my insurance is covering this, it's affordable." They're moving from kind of a submitted prescription that's waiting to obviously a dispensed prescription so they have. We're not only doing that, as Rich said, with Blink, but our field team is also trained to engage the doctors on all these updates, really working closely with the staff because they're carrying that workload too of working with the patients and going through that process. The field team has data based on each physician of what payers their patient base represents, and they're messaging accordingly. We're pulling that through and driving all those wins that we're seeing. Okay. Great. Thanks. I got a follow-up. Go ahead. No, no. I was just going to add that, again, a lot of people are telling us that they're just getting, if they're not covered, they're getting one now, but they want more than one prescription. They're getting one now at the cash pay price of $199, and then they're waiting for coverage for their insurer to cover Neffy so they can go back and get more because that seems to be a common strategy, common theme we're hearing from patients and caregivers that they just want the one initially. I know we just spoke to somebody, an advocacy person in Utah, a state advocacy person that's working on the legislation in Utah. Her kids both have this disease, and she has Neffy, and she was just waiting for her cases, everything. She wants her kids to carry it, right? She just loves Neffy because her kids can actually carry it. She went out and got it. I'm sure she'll get more prescriptions. She just wanted to get one for each of the kids initially so that they have the Neffy in their hands walking around with it, and they're really thrilled about it. That's the kind of feedback we get all the time and heard from a lot of people already in that kind of mode of, "I'll pay for the one at the $199, but then I'll wait for insurance for more." Okay. Great. That's great context. As a follow-up, you've talked about how sort of access and getting the payer coverage is really important to driving prescription because of that prior authorization burden. Can you talk about the maybe lag that you see there? I mean, how quickly when you sign a new contract or so far when you've signed new contracts and gone on formulary, are you able to see an uptick in prescribing over the following weeks or a couple of months? Or how should we think about what that sort of delay looks like? It's a great question because I just asked that question yesterday of my team. I think they're still collecting the data. I don't know, Eric, if you have it. I haven't seen it yet. The example is kind of like Express Scripts, which started now a couple of months ago. It really kind of hit with Express Scripts. How are the sales going now with patients under Express Scripts versus other insurance companies, which may have only recently added Neffy? The data will not be as impactful. I do not know, Eric, do we have any sense of that yet? Yeah. We are looking at individual cohorts of patients based on insurance. I can tell you that the last couple of weeks, especially with Express Scripts, we are seeing an incline there in terms of share relative to what we see in the overall average. That is what we expect to see. For each of those plans that we are winning, we are driving that through messaging, whether it is nonpersonal promotion through marketing, but most importantly, through our direct efforts with our field team, interacting with doctors, interacting with staff. I would say also that it takes time when the patient comes in, right? Certain patients see their doctor every six months, others maybe every year. But when they come in, now the doctor knows that if that patient has Express Scripts starting April 1, United, that this is going to be covered without a prior authorization. We are encouraged by what we're seeing in terms of the increases here. It does really create a nice opportunity for us over the next couple of weeks, and especially going into the May back-to-school season with a lot of patients coming in to really drive this. Yeah. Just to add one more thing to that, I know we're actually going a little over time a little bit. We just are now working with advocacy and on our website posting a scorecard. We wanted to wait till we cross that 50% mark, so United gets us there. We're putting a scorecard, and the advocacy groups are going to post this on their websites as well under their Neffy description, where it's going to show who's covering without any restrictions, without any prior authorization, who's covering but is still requiring prior authorization. Again, I don't differentiate between the insurer that's covering with prior authorization and one that's not covering at all, and then who's not covering at all. There are two purposes of this. One is that I want the patients to know they're covered and the caregivers, right, and the doctors. The scorecard is also being shared by our sales force with the doctors. I also want them to know who's not covering because if your insurer is not covering and you see this whole list of insurers that are, and you go and call up your insurer and say, "Hey, why are you guys not covering this?" and all these other insurers are covering it, we think that puts a lot of pressure on insurance companies to cover more quickly. That is another strategy we have to try to facilitate that by now starting to make it very public who is covering without this prior authorization requirement and who is not. We are hoping that will also start to have some impact over time. Great. Thanks. One moment for our next question. Our next question comes from Julian Harrison with BTIG. Your line is open. Hi. Good morning. Thank you for taking my questions and congrats on all the recent progress. On the CSU Phase 2b trial you expect to initiate in the next few weeks, I'm wondering if you could remind us of the competitive positioning here and any early feedback you have on preference for episodic relief versus chronic therapies in CSU. Yeah. First of all, they're very independent, okay, because these people are all on chronic therapy, right? You could be on chronic antihistamine, high-dose antihistamine therapy, or high-dose Xolair, and you still have flares. What there is no current therapy for is those flares, meaning you're on Xolair and you're stable, but every couple of months you have a big episode where you got a couple of days to a few days of severe symptoms all of a sudden, and it's very, very upsetting to these people. A lot of times they get not only the itchy and painful, but they also sometimes get facial angioedema. Their lip swells up, their cheek swells up. They do not want to go to work. They do not want to go out while that is happening. The difference is you are on your chronic therapy, and then you have a flare, and now you can have an immediate treatment to treat that flare and resolve it within minutes and then go back and just go about your daily life, go to work, go wherever you want to go, versus go to the hospital and get the other current ways they deal with this flare is you either just tolerate it and hope or wait for it to go away because it will go away, or you go to the hospital and get IV antihistamines at very high doses. It tends to be effective in a lot of cases. The other is to take a steroid, which takes hours to take effect, okay? Neffy would provide a unique advantage of treating that acute event while they're on chronic therapy. It's synergistic with chronic therapy. I just want to make sure it's clear that we are not intending to replace chronic urticaria therapy at all. This is a supplemental treatment to treat that exacerbation that occurs. If you go back to the Xolair Phase 3 studies that were published, people on Xolair even will have three to six of these events a year. Actually, more than three to six events. I should take that back. They went to the emergency room three to six times a year to treat this type of an event. It is a pretty significant issue even on chronic therapies like Xolair. Now, there are a portion of people that are just stable on Xolair or antihistamine even that never have these events, but there is a large proportion of people that have these events, so it is an unmet medical need. We are not proposing to replace chronic urticaria therapies. We are looking at supplementing them. Does that help? That is very helpful. Thank you. And congrats again. Okay. Thank you. Great. I am not showing any further questions at this time. I would like to turn the call back over to Richard. Okay. I really appreciate everybody joining the call and look forward to the next conference call when we get closer to that summer period. Obviously, we think at that point, we are hoping to see a significant uptick in scripts. Going into the summer when our DTC campaign starts in May, we really start raising that awareness. We think you'll really enjoy our DTC campaign. We've been working very hard, and we think it will be very, very positive, shifting the thinking, shifting the paradigm towards Neffy is easy, easy to carry, easy to use, and not threatening, and treat the symptoms immediately, and don't wait for severe anaphylactic disease. We think that that will really shift the paradigm towards earlier and earlier use of epinephrine in order to stop the symptoms immediately when a reaction occurs. That's really how doctors want to see epinephrine used. With that, I'll close the call. Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect and have a wonderful day.