Good day, and welcome to the ARS Pharmaceuticals neffy Epinephrine Nasal Spray FDA approval conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to turn the call over to Justin Chakma, Chief Business Officer. Please go ahead. Thank you for joining us today. With me are Richard Lowenthal, our President and CEO, and Eric Karas, our Chief Commercial Officer. We're excited to announce on Friday the FDA approval of neffy, the first and only needle-free treatment for people with Type I allergic reactions, including anaphylaxis. Both the press release and the slides that we'll use for today's call are available on the Events and Presentations page in the Investor section of our website at ars-pharma.com. During today's call, we'll be making forward-looking statements based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please see the risk factors in our SEC filings for additional details. Now, let me turn the call over to Rich. Thank you, Justin, and thank you to everybody dialing in today. This is a remarkable day for patients and caregivers in the allergy community and for all of us at ARS. We are thrilled that FDA approved neffy 2 mg as the first needle-free epinephrine treatment for allergic reactions, including anaphylaxis, in adults, patients and children who are 30 kilograms or greater. The severe allergy community has been waiting a long time for a needle-free product that offers an easy-to-use, easy-to-carry, and safe alternative to current epinephrine auto-injectors for the treatment of severe allergic reactions. Now approved, neffy offers patients and caregivers peace of mind to confidently and quickly administer epinephrine at the first signs of symptoms, which can lead to better clinical outcomes, fewer hospitalizations, and improved quality of life. Type I allergic reactions are potentially life-threatening hypersensitivity reactions that occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only known effective medication for this indication. However, epinephrine is only effective if carried, readily used, and used in time. Today's epinephrine auto-injectors, first approved over five years ago, can be painful and anxiety-inducing due to the needle injection, which can result in delay or failure to administer the life-saving treatment. This increases the risk for allergic reactions to progress to more severe anaphylaxis or other negative outcomes requiring emergency treatment and potential hospitalization. Extensive market research with patients, caregivers, and experts in the allergy field, as well as extensive historical literature, tells us that there are several critical issues with epinephrine injection devices. These issues result in a significant unmet medical need among 80%-90% of patients with active epinephrine auto-injector prescriptions who do not carry their devices or do not use them as indicated, as well as millions more who are deterred from filling their prescriptions in the first place. On Slide 4, we break down how significant that unmet medical need is. Among patients who fill their prescription, 50% do not actually carry their auto-injector devices with them at all, and of those that do carry them, up to half do not carry 2. Up to 60% do not use it when there's an allergic reaction. Instead, they go directly to the emergency room. Among those who, in fact, use their auto-injector, up to 60% delay treatment beyond the point where they should be injecting, which results in worse clinical outcomes that can be life-threatening if treatment is delayed too long. Further, among those who use the device, up to 30% fail to use it properly, which can result in lack of effective treatment. So there's great room for improvement. We believe neffy answers the allergy community's call to solve many of these problems. neffy is small, similar in size to earbud case, allowing people to carry it in their pocket discreetly at all times. neffy has no needle, and thus eliminates the fear that causes much of the hesitation to dose in the community. By removing the needle, neffy is safe for both patients and caregivers, as there is no risk of accidental injection into your hand or other extremities, which can result in an ER visit as well. As a nasal spray, there's also no risk of accidental injection into a blood vessel, IV bolus, causing a laceration or a painful injection into the bone of a small child. neffy, neffy has been shown to be both simple to use and more consistent in dosing. In fact, we evaluated the use of neffy in a group called passersby. This is someone who has no knowledge of the disease or device, but would aid a person in time of need. These passersby use neffy quickly and effectively, nearly 100% at a time, after simply reading the directions with no further education or training provided. Due to its simplicity and effectiveness, in the future, it may be possible for neffy to be available in public place for use in an allergy emergency, such as at restaurants or airplanes, where this would not be possible with injection devices, given the needle-related risks. Finally, neffy, the neffy device is highly reliable in delivering an effective dose with less than one in 100,000 chance of being outside of specifications for the dose delivered. In order to demonstrate that neffy can tolerate high and low temperatures, we've completed stability studies at 122 degrees Fahrenheit for up to three months, as well as freeze-thaw studies that show the performance in neffy is robust even under these conditions. These data give assurance that accidentally left in the car and exposed to either high or low temperature, that neffy is not negatively effective, effective, offering further peace of mind to patients. Finally, neffy's shelf life is 30 months, compared to only 18 months for approved epinephrine injection devices, which will be a value-added attribute to both patients and with payer negotiations. Although neffy can offer added peace of mind to patients, parents, and caregivers, enabling them to administer epinephrine quickly and confidently at the first signs of symptoms to stop the reaction early, while still being effective as an injection, even if administered late in an anaphylactic episode. The potential for early administration at the first signs of symptoms of an allergic reaction can lead to clinical outcomes and improvements in daily living for patients and their caregivers. With FDA's approval, as shown on Slide 5, neffy 2 mg is indicated for the emergency treatment of allergic reactions known as Type I, including anaphylaxis in adults and children who weigh 30 kg or greater. neffy is dosed as a single 2-mg spray in either nostril as soon as symptoms are recognized. A second dose can be administered in the same nostril as the first dose, starting after five minutes in the absence of clinical improvement or deterioration. As seen in the label, neffy has no contraindications and no box warnings. The warnings and precautions are simple and include potential for altered absorption in patients with underlying structural anatomical nasal conditions, as neffy did not do studies in patients. In general, factor in particular may be associated with different products in patients with coexisting heart conditions. We are very pleased with the strength of neffy's label and appreciate the productive engagement we've had with FDA during the development and review process. In particular, you will see that neffy's pharmacodynamic response, which we believe is most important to physicians, appears in the label first before anything else, and is favorable compared to injection products, even with worst-case induced rhinitis. In addition to a favorable label, we aligned with FDA on post-marketing requirements and commitments for neffy, shown on Slide 6. The first is a requirement to file our EPI-10 study and 1 mg data for pediatric patients, 15 to 30 kilograms of body weight to the NDA. We've completed this study, and we are intending to file a supplemental NDA approval for the 1 mg dose within weeks of today's conference call. The second is a registry study to collect safety data in patients having anaphylactic episodes in a clinical setting during or after oral allergy challenge, immunotherapy, or allergy shots. This study should have a nominal cost and should be completed very quickly after we initiate the study later this year. Turning to data, today's approval of neffy is based on data from over 700 study participants in 15 clinical studies in the U.S. alone, including five primary studies in adults and children with milligram dose. ARS actually has additional studies we've conducted overseas that are not part of the NDA. Per discussion with the regulators, ideal pharmacokinetic or PK profile of neffy approval was to be within the range of injection. In other words, bracketed by other injection products, PK profiles. This ensures exposures are high enough to achieve efficacy, but also within the range of approved injection products to be sure that the product will be safe. Our clinical data show that neffy's PK are within the range of approved injection products established as safe and effective and efficacious, regardless of whether it was with a single or twice dosing caregivers to adults or children upon self-administration or during nasal congestion and rhinitis due to allergens or to colds or flu. As mentioned, the PD response with neffy, which indicates receptor response administered epinephrine, was generally favorable compared to either an IM injection with needle and syringe or an auto-injector. In these studies, neffy met all regulatory confirmed endpoints within the specified PK/PD parameters. A summary of our clinical results is shown on Slide 8. PD surrogates for efficacy were comparable to or greater than approved products. There was a rapid and significant response on PD surrogates for efficacy, such as systolic blood pressure and heart rate, with response observed after dosing. neffy's PK was shown to be comparable to approved injection products, allowing the label to reference more than 100 years of real-world efficacy and safety data with epinephrine injection. Turning to safety, neffy was shown to be safe and well tolerated in our clinical studies, including with repeat doses as could occur in real life. In our clinical studies, there was no meaningful nasal irritation or pain caused by neffy, and almost all adverse events were mild and comparable to those with injection products. However, by simply removing the needle and any needle-- and any need for needle administration, neffy offers numerous safety advantages, including eliminating the risk of accidental self-injection in extremities like your hand or fingers, which can happen with either the patient or the caregiver. We remove the risk of needle, the risk of injection into the bone, lacerations, or the risk of a bolus injection into a blood vessel, which can lead to the most severe adverse events with epinephrine by administering epinephrine. Data on neffy's robust response on PD surrogates of efficacy, such as heart rate and systolic blood pressure, are included in neffy's label as the first two figures seen by physicians reading the PI and as shown on Slide 9. Physicians have a high interest in our PD data, which show that responses are observed just one minute after dosing and are favorable to approved injection products, even during rhinitis conditions and or repeat dosing. Ultimately, our goal is to make neffy available to all patients living with allergic reactions worldwide, and this U.S. approval is the first step. To do that, we have an extensive global clinical and regulatory strategy underway, as outlined on Slide 10. Within a few weeks, we expect to file a supplemental NDA for the 1 mg dose for children's 15 kg-30 kg in body weight in the United States. We received a positive opinion and recommendation for approval from CHMP in Europe at the end of June. We are anticipating a formal and we expect to bring in partner commercialization in Europe. We have already secured partners for commercialization in other regions, including Japan and China, which are on track for filing neffy in those regions in 2024. We plan to further expand to many other countries in the future. Just a few months ago, we executed an exclusive license agreement and distribution agreement for Australia and New Zealand with a subsidiary of CSL, the largest Australian pharmaceutical company. In addition, we plan to expand neffy into other allergy indications. We will be conducting a Phase 2b randomized controlled outpatient study of neffy as an acute treatment of exacerbations in patients with urticaria who are on antihistamine treatment. We anticipate reporting top-line results for this trial in 2025, after which we plan to initiate a single registration study prior to filing for approval in the United States and Europe. Urticaria patients are expected to use neffy more frequently, which would significantly increase the commercial opportunity. Importantly, we are well capitalized for these efforts with an operating runway out to at least three years, supporting the commercial launch and expansion plans for neffy. Let me now turn the call over to Eric, our Chief Commercial Officer, to walk through our commercial strategy and launch plans. Thank you, Rich. It's an honor to be part of a team that is launching the first-ever needle-free epinephrine treatment. I'm excited to lead our commercial organization, comprised of dedicated and experienced professionals who are fully prepared to deliver neffy to people with and affected by severe allergic reactions. With neffy, there is a significant opportunity to change how allergic reactions are treated. As shown on Slide 12, there are 40 million people with Type 1 allergic reactions in the U.S. alone. The epinephrine market is growing at 6.5% annually. We know this population is responsive to promotion, but there are limited direct-to-patient education and awareness campaigns today. As Rich mentioned, the unmet medical need in this population is very high, as a significant portion of patients are highly dissatisfied with current treatment options. There are 20 million patients diagnosed with a recent history of a severe allergic reaction who are actively managed by healthcare providers. Of those, only 3.2 million are actively filling their prescription, which represents the approximately 5 million prescriptions filled in 2023. We know that more than 80% of these patients don't carry their auto-injector device, don't use it, or delay using it during an anaphylactic episode. So we see a large portion of these patients switching to neffy quickly. In addition, there are another 3.3 million patients who received an epinephrine prescription in the last three years, but either refused to fill it or didn't refill it. Combined, these 6.5 million patients prescribed epinephrine are primarily managed by allergists and pediatricians, who will be covered by our sales force and primary marketing efforts. This population alone provides a substantial opportunity for neffy in the market. These two segments also indicate that they may acquire more units of neffy versus what is observed with auto-injectors today. This is because patients and caregivers are more willing to carry and use our product to facilitate continued readiness and provide peace of mind. neffy's safety and lack of needle-related risks also make parents more willing to have an extra prescription of neffy to provide to a babysitter or grandparent taking care of a child. There are an additional 13.5 million patients who have not received a recent prescription for epinephrine. This segment of patients represents an opportunity to educate both patients and physicians diagnosing them about the importance of being prepared for a severe allergic reaction and the use of epinephrine treatment. These patients are primarily managed by general practitioners and specialists who may not be as informed about the need of epinephrine as allergists and pediatricians. We have extensive plans to target these physicians with CME and virtual marketing, as well as patients with DTC advertising, including a public service announcement in collaboration with the largest advocacy group in the United States. With these efforts, even if we can get to a modest percentage of this patient population to adopt neffy, it can be a significant driver to the overall market potential for the product. Given the large eligible patient population, our pricing, and the historical gross to net of branded products in this category, this is clearly a multi-billion dollar market opportunity, even with just the patients who are currently prescribed epinephrine today. We believe neffy offers a best-in-class profile, providing patients and caregivers with a convenient, rapid, and reliable treatment by needle-free, small, easy-to-carry nasal spray. It is a simple insert and press administration of medicine. We know that two of the biggest challenges with today's auto-injectors are getting patients to carry their device and to use it in a timely manner. As outlined on Slide 13, our market research indicates a significant increase in patients who are likely to carry neffy with them, and that both patients and caregivers are likely to use neffy in about half the time they would use their auto-injector. This is precisely the design and the intent behind neffy. Over the last several months, we have conducted additional market research, including an HCP awareness trial and usage study in May. The results were consistent with previous research, and in fact, it indicated that awareness of neffy has increased over the past year. The study included 200 HCPs, of which 50% are allergists in the top prescriber category, decile eight to 10. Some of the key findings from the study are that 87% of HCPs stated they would likely or definitely prescribe neffy. The HCPs also indicated that they would offer neffy to their patients two-thirds of the time, and amongst lapsed patients, they anticipated a 70% uptake of neffy. This further supports our confidence in the opportunity to convert and grow the market. To achieve our objectives, we've built a highly experienced commercial team. Our core leaders each have 25 years of experience. I also have 28 years of experience, and this includes launching and marketing Narcan, a leading intranasal product that achieved over 95% market share at its peak. We have been through this many times, and we have the skills and expertise to successfully launch this innovative product. Our commercial strategy is informed by a deep understanding of the patient-provider experience. As outlined on Slide 15, we have three key launch initiatives: education, access, and activation. neffy offers a compelling and differentiated value proposition, addressing unmet needs for HCPs, patients, and caregivers. Coupled with affordable access and programs providing financial support for patients and caregivers, we will drive its adoption. Our plan is to create awareness, educate, and motivate patients and caregivers to ask for neffy by name. We plan to have supply of neffy in distribution in approximately 8 weeks, at which time it will be available to patients. Our sales team of 110 area managers and representatives will be calling on approximately 12,500 allergy specialists and high decile prescribers with patients who have already had or are at risk of having a severe allergic reaction. Direct promotion will be supported by extensive non-personal promotion activities, CME programs, online and print media, speaker programs, and other HCP-targeted efforts, such as the neffy Experience Program. The data we've generated with neffy in the allergy challenge setting is highly encouraging and have been well received by healthcare providers. In addition, we've designed and will soon implement the neffy Experience Program, which will offer courtesy packs of neffy for healthcare providers to use as needed during their allergy challenge clinics. We believe that enabling first-hand experience will help physicians gain an even greater confidence and enthusiasm for neffy as a treatment option for their patients. Turning to patient access and pricing on Slide 18 and 19, it's important to ensure that information and access support are readily available for a successful launch. To help ensure affordability and access, we have created neffy Connect, a platform that provides patients, caregivers, and healthcare providers with information about patient support programs and financial support to guide their treatment journey, including navigating insurance requirements. We're particularly excited about neffy Connect and the comprehensive support it will provide to patients and families in the future. We believe that every patient who needs neffy should be able to get it, regardless of their ability to pay. As we were determining the wholesale acquisition cost of neffy, we carefully considered many factors and met with stakeholders throughout the severe allergy community, including prescribers, patients, caregivers, advocates. We also spoke with many of the major insurance companies in the U.S. and did extensive modeling to understand the impacts of potential out-of-pocket expense for patients and families. The wholesale acquisition cost or WAC for 2 doses of neffy is $710. However, I'll explain, patients will pay much less. Our WAC compares favorably to competitive products in the market. neffy provides significant value by allowing for needle-free, easy to carry, easy to use, and safe administration of epinephrine. This helps to avoid delays or hesitations that could lead to worse clinical outcomes, comorbidities, ER visits, or any potential for needle-related injuries. neffy gives patients and caregivers the freedom and peace of mind they need. What a patient pays out of pocket is important to us, and as part of our commitment to access and affordability, for patients who have commercial insurance, we will provide a copay savings program so that eligible patients may pay $25 for each prescription filled. This is less than the average copay paid by patients for a generic needle injector device. For those who are uninsured or have a high-deductible health plan, we will have a cash price of $199 for 2 doses of neffy. For eligible U.S. residents who are uninsured or underinsured and meet certain criteria, our patient assistance program may provide neffy at no cost. With our support programs, the out-of-pocket cost to patients on a monthly basis, given neffy's longer shelf life, is actually less than the out-of-pocket cost to patients with generic needle injectors today. We are also working to ensure that patients with government-funded insurance, like Medicare and Medicaid, have access to neffy as quickly as possible. We expect the majority of payers to formalize their coverage decisions during the next six months, with a goal of securing 80% unrestricted access at 12 months. In the interim, neffy Connect is there to help patients access financial support and medication fulfillment services. Moving to the third part of our commercial strategy on Slide 20, we want to build awareness and motivate patients and caregivers to seek neffy as a treatment solution. Epinephrine is only effective if a patient has it with them, they use at the first sign of symptoms, and they administer it properly. In addition to our direct promotion to prescribers, we have plans for broad print and digital promotion to help drive adoption. Our consumer campaigns aim to ensure that patients and caregivers are aware of neffy as a needle-free, easy to carry, easy-to-use product. People with or at risk of severe allergic reactions should feel empowered and prepared for a potential emergency moment, and our goal is to make that happen. We've already heard significant enthusiasm for neffy amongst patients, and in particular, the parents of children with severe allergic reactions. It's important that these individuals know they have a treatment option and that they can ask their healthcare provider for neffy by name. I want to echo what Rich said earlier. This is an incredible moment for the severe allergy community. neffy's approval represents the first significant innovation in the delivery of epinephrine in over 35 years. We are excited to bring neffy to the market in the next several weeks and look forward to keeping you updated on our launch progress. I will now turn the call back over to Rich for closing remarks. Thank you, Eric. If I look back to when we founded ARS in 2015, we had a goal of solving the significant issues patients and caregivers expressed about their epinephrine injection devices. I'm very proud of the work by this team to take a well-known, life-saving medication and create a needle-free, easy to use, easy to carry, safer alternative, so that patients and caregivers would have less hesitation to dose immediately after symptoms of an allergic reaction are detected. I'm equally proud of the scientific and medical data we've generated under the direction of Dr. Sarina Tanimoto, our Chief Commercial Officer. I'm sorry, Chief Medical Officer, with some of the country's top key opinion leaders, which has resulted in significant contributions to the understanding and science of epinephrine. This approval is a result of many people's insights and contributions, and we are grateful to all of you. Thank you to our collaborators, advisors, investors, and the patient advocacy community who have provided their unwavering support over the years. Thank you to the physicians and healthcare providers who have been part of the numerous neffy clinical trials and have been committed to bring neffy forward as a treatment alternative. Most importantly, thank you to many patients, families, and caregivers who have participated in our clinical trials and have shared your enthusiasm for this new treatment, especially those that participated in our pediatric study with children down to four years of age. In closing, neffy represented a transformational shift in the treatment of severe allergic reactions. For the first time, physicians can now offer patients and caregivers a safe and effective needle-free epinephrine treatment to confidently and quickly use at the first sign of symptoms. We look forward to bringing neffy to patients this year. We appreciate your attention and would be happy to take your questions. Thank you. If you'd like to ask a question, please press star one, one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again. Our first question comes from Tim Lugo with William Blair. Your line is open. Thank you for taking the question, and congratulations on the approval. It's obviously a significant day for the company and for patients. My first question is, you know, and this is probably one of the most common questions I think those of us who try to model launches get is, you know, payers have been requiring significant rebates for these type of launches. Can you speak to kind of your preliminary discussions with payers? And as we model the launch, what kind of gross to net we're going to have to assume in the near term, and then maybe even, you know, the medium term, and what kind of, you know, near term years versus, you know, 2025 versus beyond that will look like for GTN? Yeah, Tim, Rich Lowenthal here. I'll start out with that answer, and then, if Eric wants to add anything, he can add a little bit to the response. But we are—we've done very extensive market research. Our board has challenged us fairly significantly on this and access research, and we've talked to many, many payers, and we've obviously had multiple access research studies with three different companies that we've used. We believe that neffy will be very quickly covered. There's a very low barrier for the insurance companies to cover this. They understand the unmet medical need. With the longer expiration date on a per monthly basis, the cost to the payers will actually be less than generic auto injectors, so not only to the patients, but to the payers themselves. So we don't see much barrier here, Tim. We don't see that our discounts will have to be significantly more than what is typical for pharmaceutical products. And therefore, our gross to net, while we can't give you accurate numbers today, will probably be also typical of most innovator products. We don't anticipate any remarkable discounts or any other issues with getting access, reimbursement, coverage quickly. Eric, do you want to add anything to that? Yeah, a couple points. Thanks, Rich. Tim, I would say over the last six to nine months, we've had interactions with several of the large PBMs, payers, and have been very positive. As Rich said, they clearly see the differentiation and the value of this product on many of the attributes that we've obviously talked about, and as Rich mentioned, the shelf life, temperature excursions, all of those things. They also understand the challenges that patients face with needle injectors today. It's pretty evident. We all know it's in the literature. We hear it all the time, and they see the potential cost that has on the healthcare system. So that message overall is pretty strong for us, and they really, again, see the value of this product. And then the last thing I'll say is, in this marketplace right now, the PBMs are not getting a lot of rebate dollars, so it really makes sense for them to contract with us in order to make this product obviously available to patients easily. Understood. And maybe, you know, tacking on to that, I know you're going to have the pediatric study for 15kg-30 kg completed and filed in Q3. Can you just talk about how large that population is for kind of the total addressable back-to-school pediatric population? Yeah, it's around 15% of the overall population. So, you know, the current approval for 2 mg is roughly 80% or a little over 80% of the population. There's about 15% that are in that 15kg-30 kg, and then there's a small percentage below 15 kg. And by the way, while we don't mention it, Tim, FDA did not require us to develop a product for under 15 kg, a dose and device modification for small, small babies. But the European Medicines Agency, PDCO, their pediatric committee, does feel it's critical to have a needle-free option for even down to one years of age infants. And we do have a commitment in Europe, and we'll be a lower dose and a product that will be suitable for babies, for nasal administration, hopefully within the next two years we'll have. All right. Thank you for all that. Congratulations again. Thank you, Tim. Thank you. Our next question comes from Ryan Deschner with Raymond James. Your line is open. Hi, good morning, and congratulations on the early approval. I just wanted to ask about neffy's differentiated shelf life and your latest views on the impact of the shelf life from a patient and a payer perspective. And then also on commercial readiness, how far along are you with hiring, and how long do you think it will take to get sort of all hiring onboarded and trained ready for launch? Thanks. Yeah. So, I'll start out again. Actually, the impact of the shelf life and not only the shelf life, but the temperature excursions that allow for both high and low temperature excursions is fairly significant. I mean, I could tell you that we've been getting a flood of emails from doctors, consumers, patients, caregivers, and I would say a good percentage, at least a third, are asking about this particular point, and especially high temperature excursion. Because they tell us over and over, and we've known this for many years, that people actually throw away their auto injectors because they left them in the car in the summer. And it's really the reason we did what we did, is we felt our formulation, based on the science, would be much more stable. We actually stored it at 122 degrees Fahrenheit, 50 degrees Celsius, you know, for three months and showed it still passed for potency at three months. And that was fairly strong to FDA, and that's why they gave us this excursion statement, which is a little unusual, allowing short-term exposure, again, not intentional, but accidental exposure. We don't want people to intentionally store at high temperature. But if you did leave it in your car, you could have assurance that the product was still safe to use and effective, right? And that's very important for patients and caregivers. It reduces the anxiety of having their medication and knowing that it's going to work if needed. In addition, while we do recommend in the label not to freeze, because if it's frozen, it does take about 20 minutes to thaw. And that's too long of a period of time in an anaphylactic emergency. So we don't want people to intentionally freeze it. But if it's accidentally frozen, it won't hurt either the device nor the product inside. And that's also very important to patients because a lot of devices, they warn people to throw them away if they accidentally freeze because the mechanism in the device could be damaged. So that's a huge benefit, and the longer expiration date is also a huge benefit. And we don't expect it to significantly negatively impact sales, in fact, because the feedback we get from our market research is when people hear that it will last longer, they feel they more devices to manage their daily life. And they're more willing to buy more devices if they last longer and not to throw them away in one year. So that's a huge benefit in that they not only it won't impact the volume of sales, we believe, but in fact, it will make it better for our patients and caregivers to manage their daily lives by being able to have more devices available to them for the same cost, to put in more places and with more people that manage the patient, child, let's say, with anaphylaxis. Now, going back to readiness to launch. We've already manufactured lots at risk, and we're now in the process of assembling and packaging those lots to launch as soon as possible. We anticipate launching within 8 weeks, possibly sooner, but well, certainly within about 8 weeks. And I believe Eric's team, and he can speak to this more, is very well set to be in a position to launch right away. We will have our initial 95 reps that we planned almost immediately. We have most of them already with offers in hand. So we've already identified almost all of these reps at time to start ramp up to 100 reps, and then, and then evaluate the different channels of marketing. We've got a very well-balanced plan. We've got some really exceptional people on our board, as you know, including Brent Saunders, who've gone through this, spent a lot of time with us and helped us fine-tune our launch plan. We have a very well-balanced plan, but as things materialize, we'll see what's most effective, and not only for the population of people who are switching, but even those who have lapsed or refused prescriptions, which is almost an equal number as Eric showed. So 3.2 million with prescriptions, 3.3 million who have had a prescription but let it lapse or did not fill it. But there are also 13.5 million that have never had a prescription, but probably should have epinephrine. They've been diagnosed with severe anaphylaxis. We'll see what is most effective in getting to those different populations, and we'll obviously apply additional capital to those channels as things materialize. Eric, do you have any other additions or like coverage? Thanks, Rich. Yeah, a couple of points on the preference share, just to add on the 30 months. You know, Ryan, we also saw an increase from a physician perspective of their preference shares as a result of this. And as Rich was saying, you know, we're looking at this not only the patients that currently have treatment, but those 3.3 million that don't. When we talk to lapsed patients and patients without treatment, this was also more attractive to them to have that shelf life and made a difference in their likelihood of engaging a physician to talk to them about neffy. And then obviously with payers, it's another leverage point to show the value of the product. And as Rich said, the core team has been ready to go. We've had, you know, marketing leadership, marketing, market access, commercial operations, and sales leaders on board for well over a year. To Rich's point, we converted the 75 sales reps that had contingent offers. We made them offers on Friday, and they'll be starting in a few weeks, and then we'll be recruiting for the other 20. That's ongoing right now to get up to 95 at this point. So we're in a very good position. We're excited about bringing this product to market. Excellent. Thanks, and congratulations again. Thank you. Thank you. Our next question comes from Roanna Ruiz with Leerink Partners. Your line is open. Great. Morning, everyone. So, I was curious, will there be any inventory stocking dynamics around neffy's launch that we should consider? And just digging into the manufacturing piece a little bit more, can you talk a bit about your ability to adapt if there's a possible surge in demand for neffy later this year or into 2025? Yeah. Right now, as I said, we've manufactured several lots of neffy already at risk for launch, and that, you know, prior even to getting the approval. And we're also in the process of scaling up, you know, approximately 7-fold, 6, 7-fold on our scale of production at this point in time. And our production facility, Renaissance, has quite an extensive capacity. So they can ramp up production very quickly and very effectively. So we don't have much concern about capacity. If the sales... Let me put it this way, Roanna. If we get into any kind of delay in delivering neffy, based on the initial demand, it will be a quite remarkable demand. I think people will be quite shocked at the initial sales volume, if that's the case. So if that occurs, we hope not. We hope we're prepared, and we hope that we'll be able to keep up with demand and scale up, once, especially once we get to that full-scale production capacity by later fourth quarter this year. If we exceed that demand initially, it will be quite remarkable. Sounds good. Just quick follow-up for me. I was curious how quickly could neffy be adopted in, you know, more public areas like schools, college campuses, possibly ambulances? Like, how are you thinking about those avenues for the product? Yeah, we think quite quickly. In fact, we're already talking to the largest manufacturer of emergency kits for airliners and other sources. We've been approached even proactively by hospital sources and especially on hospital emergency, you know, types of places. Restaurants and other places, I think that may take a little more time, but certainly neffy is well situated for that, as we said, because you don't need any training. I mean, it's the same device used for Narcan OTC, so no training, no medical intervention at all is necessary to actually be able to understand and use this product effectively. And the biggest advantage in using it, as we mentioned, is there's no needle, so there's no safety concern. And in fact, you know, working with different regulatory agencies around the world, we got different requirements in every region, so we actually covered quite an extensive array of possibilities, even on none to show that even if neffy was accidentally sprayed in the air or into the face, it would actually be harmless to somebody's eye. So you really can't hurt somebody with neffy, which is the biggest issue with having an injection device in a public place like a restaurant, where a passerby could use it, if somebody who's a Good Samaritan trying to help the patient uses it and injures themselves and has to go to the hospital. And that's a huge liability for a restaurant or an airlines or any other public type of situation like that. That's been a major barrier for epinephrine use in that kind of public arena. So we see neffy as breaking through that and being able to be used any place, anywhere. Hopefully, it will be like a defib, defibrillator, where it will be in location all over the country and in public places for public use when needed. Understood. Thanks for clarifying. As a reminder, to ask a question, please press star one, one. Our next question comes from Julian Harrison with BTIG. Your line is open. Hi, good morning. Congratulations on this early approval, and thank you for taking my question. Out of the almost 14 million diagnosed in the past three years, but not prescribed an epinephrine as a therapy regimen or option, I'm wondering how much you think injection aversion or out-of-pocket costs are driving that? And, I'm curious if you have any plans to target that segment specifically. Yeah, it's a good question. We don't believe that out-of-pocket costs are driving that at all. In fact, they're very little. We've done a lot of research on that group, by the way. I'm actually maybe obsessed with that group, why they're not getting epinephrine. Only about 2%, unlike the other 6.5 million, who are almost exclusively with allergists and pediatricians who are well, only about 2% of this 13.5 million are with allergists. So unfortunately, it's a population that's being diagnosed by general practitioners in emergency rooms, even by OB-GYNs, is a huge category here, so maybe primary doctor for women. And what's happening is that they're getting diagnosed and they're either being told to avoid the antigen or they're being given an antihistamine or an inhaler. They're not being given epinephrine. And we believe it's a lack of education, not only of the actual doctors, but also of the patients. So how are we gonna get to them? Now, we're not going to go to general practitioners. However, we already have arrangements with groups like the American College of Allergy, Asthma, and Immunology, to start CME programs targeted at the doctors. We can identify who has patients who have been diagnosed with anaphylaxis, but not target them with CME programs. We can also target them with direct virtual advertising and promotion. We can also go and try to expand the patient population by targeting those patients who are not aware that they need epinephrine. They know they have anaphylaxis, they know they've had reactions, they've been in the hospital emergency room, but they don't know really because their doctor hasn't informed them properly. And we're gonna target them first through FARE, the largest advocacy group. All of the groups are super supportive of this, by the way, but FARE, we have now an agreement to start a public service announcement campaign, which we will sponsor, and that will start very, very soon to start getting out there and trying to make these people more aware of the need for epinephrine and the need to treat their disease. We'll also transition into direct-to-consumer, of course, and do a very heavy direct-to-consumer campaign, which I anticipate ramping up over the year. And we believe we'll get to a lot of those patients as well. And again, getting those patients aware of the need for epinephrine, and now there's a needle-free, easy-to-use, safe, painless device that could be used to treat them, that's easy to carry. We're hoping that a lot of them will either go see allergists or go back to their general practitioner and say, "Hey, why didn't you prescribe this?" And that will drive the doctors to prescribe neffy more in that population. And again, as I mentioned earlier, we're gonna be looking very carefully at the different channels of our commercial efforts and what starts to become effective in that population. We believe we can very effectively measure that, and then obviously, we'll focus more and more attention. Not, you know, again, our sales force is gonna be visiting the other 6.5 million patients and their prescribers pretty regularly, and we're also gonna be obviously promoting to that group. But this 13.5 million into the advocacy groups, that's the group that looks the most need, because they don't even understand that they need epinephrine and that there are safe alternatives that they can get. So we don't believe it's price at all, in fact, or very little, because they've never actually received a prescription, so they've had no opportunity to even reject a prescription based on the cost. They just have never received a prescription because they're just not aware, the doctors are not aware of the way to treat this disease properly. Very helpful. Thank you, and congrats again. Yep, thank you. Thank you. There are no further questions. At this time, I'd like to turn the call over to Richard Lowenthal for closing remarks. Okay, thank you. In closing, neffy represents a transformative shift in the treatment of allergic reactions. For the first time, physicians can now offer patients and caregivers a safe and effective needle-free epinephrine treatment confidently and quickly at first signs of symptoms. We look forward to bringing neffy to you soon, and we appreciate everybody's involvement in today's conference call, and also appreciate the questions you've asked. Thank you. Thank you. This does conclude the program, and you may now disconnect. Everyone, have a great day.