Good morning. With me today are Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma; Eric Karas, 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 developments and insights into the neffy launch. Eric will discuss neffy’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 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. In September, we 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% with our 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 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 who 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 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 Quad AI meeting, a study in Japanese patients experiencing anaphylaxis symptoms after oral food challenges found that patients receiving it experienced lower symptom scores within 10 minutes compared to traditional intramuscular injection. A separate set of clinical studies in China reinforces the 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 Quad AI 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 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, which accounts 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 the 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 used neffy for oral food challenges and immunotherapy treatment. At Quad AI, 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 very severe anaphylactic reactions, even from being unconscious. Physicians are clearly and enthusiastically communicating to us that they believe 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 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 a 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 in the early part of the S curve of what we anticipate to go into a multibillion-dollar blockbuster peak sales trajectory. We anticipate a significant inflection in both the depth and the breadth of healthcare provider prescribing later this year as the headwinds from 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 authorization poses 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 generate 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 the feedback from hundreds of prescribers, including most recently at the Quad AI meeting, we expect to see a tipping point in the neffy trajectory as we obtain 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 large 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 have also signed contracts and provided patients with unrestricted access to neffy with two other group purchasing organizations, MSR and Zinc, at terms that preserve a greater than 50% gross to net yield. MSR 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, United Healthcare will also add neffy to their formulary with unrestricted coverage under the MSR agreement. Just in 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, and 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 the 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 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 2025. In parallel, we are also on track to have a global commercialization footprint with neffy within one year from now. As a reminder, Euro neffy, 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-Abello, is preparing for commercial launches in Germany and the 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, the demand from physicians and patients for neffy is clear. 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 to us and give us a 50% gross to net yield 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 adoption of neffy across the board through the 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 net 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 neffyconnect. 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 Quad AI 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 teams met with at the conference, the feedback regarding the product was overwhelmingly positive. Many healthcare providers who have used neffy in a clinical setting as part of the experience program shared their experiences. One particular influential physician who is a thought leader among 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, and as shared — 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 challenges, 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, Optum, 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, including Athens in late Q4 of last year and Zinc and MSR in the last few weeks. We expect downstream payers of these GPOs to adopt the negotiated terms and add neffy to their 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 reducing 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 send prescriptions directly to retail pharmacies, such as CVS and Walgreens, more easily. For patients with commercial insurance, our co-pay assistance program has made neffy more affordable. Most commercial patients only pay $25 for each prescription, which is lower than the average co-pay of $40 for a generic auto-injector. Our co-pay 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-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 timed 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 targeted 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 will 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 in 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 nonrefundable 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. So 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 nonrefundable 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 agreements 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 will 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 United States, $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 in 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 the 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 to $210 million for the full year 2021. 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 the adoption of neffy and expanding global market access and advancing our intranasal epinephrine technology with the plan to start Phase I 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.

Our first question comes from Ryan Deschner with Raymond James. Your line is open.

Hi, good morning. And thanks for the question. 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? And then I have a follow-up.

Yes, we believe it's additive. It's about 23% of the market. However, the impact on the sales ramp of neffy is likely greater, as the current adoption is heavily focused on children. Adding younger children, whose parents may have more concerns about injections, should be very beneficial. As we mentioned, we expect this to be significant in 2024, where it was 23% of the prescriptions for epinephrine injection. Therefore, we think this 23% will have a significant impact on our sales ramp.

Got it. And then just one more, I wondering if you could give us any more detail on the progress towards the 80% access goal, which I think was more towards the end of the third quarter. It sounds like it's evolving. And what proportion of neffy sales do you expect to come from public programs like Medicaid? Thank you.

Yes. I'll elaborate on that, and then Eric can add anything I might miss. As of April 1, UnitedHealthcare has reached an agreement with us, allowing for unrestricted access starting that date. At that time, approximately 51% of commercial patients will have access without prior authorization. While the total figure is slightly over 60%, we focus on those without the need for prior approval because that's a significant barrier for many physicians, even those who support neffy. They often communicate that they have limited time during the day and on weekends to handle prior authorizations, which poses a challenge. We recently signed an agreement with Zinc, which represents Caremark, Anthem, and several other insurers, covering more than 25% of the commercially insured market. However, Caremark typically adds items to their formulary only on January 1 or July 1. We currently anticipate that neffy will be added to their formulary by July 1. They do make exceptions, so it could happen sooner, but we're uncertain at this moment. If Caremark adds neffy to the formulary by July 1, we expect Aetna and Anthem to follow suit as well, meaning unrestricted access where no prior authorization is needed, as they already approve prior authorizations quite readily. We anticipate unrestricted access for them by July 1 or possibly sooner. This would position us close to the 80% mark. Certainly, when considering all coverage, but even just unrestricted access should bring us close to that 80% goal by July 1. We find this very promising as we head into summer, alongside our direct-to-consumer campaign and other initiatives aimed at making doctors more comfortable with prescribing neffy. We believe everything will align for the summer season and hopefully boost sales during that time.

Thanks for the color. Appreciate it.

Our next question comes from Alexa Deemer with Cantor Fitzgerald. Your line is open.

Good morning, everyone. This is Alexa Deemer on for Josh Schimmer, and congrats to the ARS Pharma 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.

Currently, very little is being sold outside of the retail market, so almost all of our sales are through retail. We are collaborating with the two largest kit manufacturers for airlines that want to replace other epinephrine products in their kits. Airlines need to opt in, but there are many advantages to neffy, including ease of use and the absence of a needle, which diminishes liability for the airlines, as well as important temperature excursion data for use on airplanes. However, I don't think much, if any, revenue is coming from outside of retail right now. We anticipate that will grow over time, but it takes time for that to happen. For instance, the kit manufacturers did not want to introduce neffy kits until the 1 milligram dose was available, so they're waiting for both doses. When that happens, we expect sales to start increasing gradually. However, this won't be immediate, as they won't be discarding all their kits or replacing all their epinephrine products at once; they'll do so over time as those items expire. Eric, would you like to add anything?

Rich, I'll just add that when we look at our forecasting, it's really focused on the retail market. As Rich mentioned, this public interest market of airlines, you can think about hotels, restaurants, law enforcement, emergency rescue, that's not included. But as time goes on in terms of education and awareness and then getting funding, we do have an opportunity in that channel. And then 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. So again, once that's available, there are no issues with the doctor writing for the 1 milligram in addition to the 2 milligram.

And I'll just add one more point to that because one of the things you need in the retail market is to find a way to make it easier for some of these organizations such as restaurants to purchase neffy, right? So 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 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 because that would potentially pay for the neffy or the restaurant by giving a discount on their insurance if they actually have the epinephrine in the restaurant. So those kind of things are all happening. But again, it will take some time before we start to realize significant revenue from those type of opportunities.

Awesome. Thank you and congrats again.

Our next question comes from Louise Chen with Scotia Bank. Your line is open.

Congratulations on all the progress this quarter. And thank you for taking my questions. I had a few for you. So first question I wanted to ask you was, how long does prior authorization for those payers that require you to do it usually last, or does it have to be renewed?

Yes, I believe they need prior authorization for each prescription. The situation is a bit unusual since patients might only receive one, two, or three prescriptions per year. Therefore, prior authorization is needed for those prescriptions, and we have seen cases where three prescriptions are processed together. However, they likely have to obtain prior authorization each time, which creates a significant burden. Currently, we're averaging 1.3 units per prescription in revenue, and we expect this to increase as many purchases are cash payments and patients will buy more once their insurance covers it without restrictions. Each prior authorization results in a very small net revenue, which is why we see this as a major obstacle for doctors. Would you like to add anything, Eric?

Yes, I would just say it's a mix. It depends on the insurer, as Rich mentioned, some will require every single time; others may be a little bit longer. But 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. And when we say that, that's covered with no prior authorization. All of our contracts that we're putting in place with the GPOs and with PBMs, again, we’re not paying any rebates if there's any type of step edit or prior authorization. So we're really confident that we're lowering the barriers in time here for physicians to write this product without a prior authorization.

Okay. So I wanted to ask you for patients that were previously diagnosed and 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. But from an opportunity perspective, as we've shared, there are 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 that, over the last couple of years, there are 3.3 million patients that have been prescribed epinephrine; about 1/3 of them have filled, but they haven’t refilled. So there is an opportunity, 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 didn't refill or fill initially is because of the needle, size, portability, and affordability as well. So when you look at our programs in commercial, again, if they are covered, it’s $25 for the prescription, even if they get more than one carton, we only charge one co-pay, but we’re able to again, get reimbursed on two cartons or three cartons. The average co-pay for a needle injector is about $40. So I think we’re removing a lot of the challenges in terms of a needle-free, easy-to-use portable option, and we do see a very significant opportunity to reengage this population, whether it’s through the physician or our DTC efforts that we’ll launch in May.

Can I ask one more quick question?

Yes.

The opportunity for epinephrine to go over the counter, what would that mean for you?

Yes. 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, your first safety. We believe neffy is very safe, especially with only two doses. You can overdose on epinephrine. So that is a big risk, and the FDA has raised significant concerns about levels above that observed with two EpiPens. So that's been a significant discussion for years that they just don't know the safety in real-world patients with levels above that. So people that might take more than two doses of neffy would be a concern to the FDA. The other criteria is self-diagnosis. You’ve got to be able to self-diagnose that you have the disease. And there are a lot of causes of symptoms similar to food allergies that may or may not be an actual food or venom allergy, so the FDA would also have to get over that barrier of the ability of people to self-diagnose. So while it's a discussion and would be interesting, I think it's a difficult hurdle for this type of product, just the profile for the FDA. So I would not expect it to go OTC, certainly in the near future. I would not expect that to happen.

Our next question comes from Roanna Ruiz with Leerink Partners. Your line is open.

Good morning, everyone. So 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? And as you gather this data, would you present it in sort of a rolling basis this year at medical meetings or publications?

Yes. So first of all, this is going to be the largest randomized controlled study ever done with epinephrine. Never been a study like this done. But now that we're approved, the FDA believes it's feasible, and we believe it's feasible. It will be 600 people treated, 400 on neffy, 200 on IM injection. And again, it will be randomized and partially blinded. By partially, 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 the clinic not having a reaction. So the 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 challenges to that is eligible to enroll. That would normally get epinephrine if they have a reaction. So it's a really real-world study where you're going to get patients with asthma with all sorts of other concomitant medications. Nothing is barred in this study. We'll get a really good sense of the safety of neffy and also of injection. So even for IM 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, so that's the nature of the study. 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, but we probably will do an interim analysis so that at least preliminary data will be presented probably at the next Quad AI meeting and 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; they wanted to understand the safety of neffy and have better data on the safety of neffy. We understand its side effects are very mild and very infrequent. But nonetheless, they want to see in patients that actually have a reaction and on all their concomitant medications or have all their other concomitant conditions that you typically see in this population. So that's really the main focus of the study. And we will probably do an interim analysis for Roanna. So that's helpful as well.

Yes. Got it. Interesting. And then I wanted to follow up. I thought your KOLs back that you mentioned earlier was really interesting in terms of physicians that want to switch all of their patients to neffy or possibly a majority. A sense of the proportion of physicians out there that you're detailing that have this interest?

I think the feedback is mixed. Some of the leading physicians we engage with at Quad AI are proactively educating themselves and attending meetings. I've spoken to several of them, and one significant physician mentioned that he simply cannot spend all evening and weekends handling prior authorizations. He's quite selective, but he would consider switching nearly all his patients to neffy, as he believes they would prefer it. He also serves as a key advisor to pediatricians and general practitioners in his area, advising around 100 pediatricians and a couple of hundred general practitioners about patients’ inquiries. None of those pediatricians are willing to handle prior authorizations; they just won’t do it due to time constraints or lacking the support in their clinics. They won't take action until this barrier is removed. However, they're reaching out to him about neffy, particularly for prescribing to children, which is a significant focus for many doctors right now. We believe this interest is widespread. Some physicians are still waiting for real-world data, and we are in the process of gathering impressive real-world data from neffy experiences. Currently, we have reported data from about 758 patients treated by 478 doctors, showing that the treatment appears to be as effective, if not more so, than injections. Once we have a larger sample size, perhaps a couple of thousand, we might publish a letter to the editor in major medical journals to share our findings. Many doctors are waiting to see broader patient application and successful outcomes before they consider prescribing neffy. They all recognize that neffy has a far better profile and is a superior option compared to injections, but there is still some hesitation. One of our key focuses is ensuring easy access for patients, making doctors comfortable with prescribing, and collecting real-world data showing effectiveness equivalent to injections. Additionally, we need to raise awareness among patients and caregivers about neffy’s availability without complications or excessive costs. This will be a major initiative, and we plan to align our direct-to-consumer campaign with improved access. Some believe that having over 50% access is sufficient to start attracting patients to doctors, but we aim to begin this process closer to the 80% mark to ensure smooth and affordable access for everyone.

Makes sense. Thanks a lot.

Our next question comes from Lachlan Hanbury-Brown with William Blair. Your line is open.

Hi everyone. Thank you for the questions. The first one is about the system you have in place for reaching out to doctors or patients who received a prescription that wasn't approved until coverage is secured with the insurer. Can you discuss that system and what results you've observed from it so far?

There are two separate aspects to consider. If it’s through BlinkRx, our online pharmacy, BlinkRx maintains a record of all patients who were denied a prior authorization or who filed one. We have their data and contact information since they used BlinkRx. As new insurers are added to our coverage and we gain unrestricted access, they can notify both the patient and the doctor that the patient is now eligible for neffy without needing prior authorization. Eric's team is managing this effectively. The second aspect is more challenging if the prescription was filled through a pharmacy. Even with cash pay options or if a patient lacks co-pay assistance, we risk losing patients who might abandon their prescription. We aim to encourage them to visit the pharmacy with a reasonable $25 co-pay. To help with this, our sales force is actively informing doctors that their patients are covered by certain insurers, such as United starting April 1st. If you’re a UnitedHealth patient, which makes up about 8% of commercial insurance in the U.S., you can return to the pharmacy to get the script filled again or pick up neffy without needing prior authorization if the script is still valid. Additionally, we want to ensure that patients do not miss out on a co-pay. For example, if there's an $80 co-pay for neffy with United but they would prefer to use a $25 co-pay through a coupon from our website, we are working diligently with CVS and other health organizations to set up an agreement to preload that card. This way, when patients and caregivers visit the pharmacy, they won't need to present a coupon. Surprisingly, even someone I know who has used neffy multiple times ended up paying $200 despite having prior authorization and insurance. I was astonished when she mentioned she didn't use the coupon. We don't want to see that happen because, although she could afford it, many people wouldn't. So, we are focused on creating a seamless experience: patients receive their prescription from the doctor, go to the pharmacy—whether presenting a physical or electronic script—and are informed that their co-pay is just $25, leaving them satisfied. That’s our goal, to streamline this process for the majority of patients as quickly as possible, especially as we approach the summer.

Great. I mean, can you comment on the sort of coverage that you've won so far? Have you seen many of those groups, for example, the ones through BlinkRx go back in that filled? Or are those patients, maybe when the initial script is denied, do they just get a script for an auto-injector?

Yes. I'll refer to Eric. Eric, do you have any information on that as to when BlinkRx goes back after coverage?

Yes, Lachlan, we are seeing some of those patients start to convert. We have a protocol in place, as Rich mentioned, that we’ve been implementing over the past few weeks to reengage those patients once we secure coverage. Some have chosen to pay out of pocket for the prescription, but many are returning to let us know that now their insurance is covering it, making it affordable for them. They are transitioning from a submitted prescription that is still pending to one that is actually being dispensed. In addition to the efforts with Blink, our field team is also equipped to communicate these updates effectively with doctors and their staff, who handle most of the patient interactions. The field team uses data specific to different physicians to understand their patient demographics and tailor their messaging accordingly, which is contributing to the positive results we’re experiencing.

Great, thanks. Can I ask a follow-up?

I wanted to add that we've heard from many individuals that if they are not already covered, they are obtaining a single prescription now for the cash pay price of $199 while waiting for their insurance to cover neffy, so they can acquire additional prescriptions later. This appears to be a common strategy among patients and their caregivers; they want to secure at least one prescription initially. I recently spoke with an advocacy representative in Utah who is involved in legislation and whose children both have this disease. She was eager for her kids to have neffy, so she purchased it herself and plans to get more prescriptions later. Initially, she just wanted to ensure her children had one each, and they are very excited about it. This feedback aligns with what we've consistently heard from many others who are willing to pay for the initial prescription while waiting for insurance coverage for more.

Thank you for the context. As a follow-up, you've mentioned that having access and securing payer coverage is essential for increasing prescriptions due to the challenges of prior authorization. Can you discuss any delays you observe in this process? Specifically, when you enter into a new contract and are added to formularies, do you typically notice an increase in prescriptions in the following weeks or months? How should we interpret any delays in that regard?

It's a great question because I just asked that question yesterday of my team. I think they're still collecting data. I don't know, Eric, if you have it; I haven't seen it yet, but the example is kind of like Express Scripts, which started a couple of months ago. It really kind of hit with Express Scripts. So how are the sales going now in the patients under Express Scripts versus other insurance companies, which may have only recently added neffy? The data won't be as impactful. But I don't know, Eric, do we have any sense of that yet?

Yes. We are looking at individual cohorts of patients based on insurance. I can tell you that the last couple of weeks, especially with like Express Scripts, we're seeing an incline there in terms of share relative to what we see in the overall average. So that's what we expect to see. For each of those plans that we're winning, we're driving that through messaging, whether it's non-personal promotion through marketing, but most importantly, through our direct efforts with our field team interacting with doctors and interacting with the 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. 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 and 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.

And 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 our website posting a scorecard. We wanted to wait until we cross that 50% mark if United gets us there. But we're putting the 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 that's not covering at all. I want patients to know they're covered and the caregivers, right, and the doctors, so 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. So that's 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, and we're hoping that will also start to have some impact over time.

Our next question comes from Julian Harrison with BTIG. Your line is open.

Hi, good morning. Thanks 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?

Yes, first of all, these individuals are very independent because they are all undergoing chronic therapy. This means they might be taking high-dose antihistamines, high-dose gene therapy, or high-dose XOLAIR, yet they can still experience flares. Currently, there is no therapy specifically for these flares, which can happen even when someone is stable on XOLAIR. Every few months, they may endure severe symptoms for a couple of days, which is very distressing. During these episodes, they may experience not just itching and pain, but also angioedema, causing their lips and cheeks to swell, making it difficult for them to go to work. The key difference is that while on chronic therapy, if a flare occurs, there is now an immediate treatment available to address that flare and alleviate it within minutes, allowing individuals to resume their daily activities instead of going to the hospital for IV antihistamines at high doses, which are effective in many instances. Currently, when faced with a flare, patients typically either endure it in hopes it resolves or seek hospital treatment with IV antihistamines. Neffy offers a unique advantage by treating these acute episodes while patients are on chronic therapy, making it complementary to these therapies. I want to clarify that we do not intend to replace chronic urticaria therapy; instead, this serves as a supplementary treatment for the exacerbations that occur. Referring back to the published Phase III studies on XOLAIR, patients often end up in emergency rooms three to six times a year due to these events. In fact, many experience more than just three to six events annually. Although some individuals on XOLAIR and antihistamines remain stable, a significant portion still faces these flare-ups, indicating an unmet medical need. We are not aiming to replace chronic urticaria therapies, but rather to enhance them. Does that help?

That's very helpful. Thank you. And congrats again.

Okay. Thank you. Great.

And I'm not showing any further questions at this time. I'd like to turn the call back over to Richard.

Okay. Well, 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're hoping to see a significant uptick in scripts and then 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 where we've been working very hard, and we think it will be very, very positive shifting the thinking, shifting the paradigm towards neffy, easy to carry, easy to use, and not threatening, and treat the symptoms immediately and they'll wait for severe anaphylactic disease. We think 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. So 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.