ARS Pharmaceuticals, Inc. (SPRY) Earnings Call Transcript & Summary

Good morning, everyone, and welcome to the ARS company presentation. My name is Ethan Taylor. I'm an associate in JPMorgan's Healthcare Group. Before we begin, a quick note, there will be some time towards the end of the presentation for some audience Q&A. So please have some questions ready. So with that, it's my pleasure to introduce Richard Lowenthal, Co-Founder and CEO of ARS. Thank you.

Thank you very much. It's very proud today to present to you ARS Pharmaceuticals and our first commercial product, neffy. So neffy is a needle-free option for treatment of type one allergic reactions, epinephrine. So it's the first needle-free product approved by the U.S. FDA and EMA. Forward-looking statement. Now that you've memorized that, we'll move on. So again, neffy is the first needle-free choice for treatment with epinephrine. Epinephrine is the only drug that actually can treat a severe type I allergic reaction and stop the reaction. So other therapies, antihistamines may treat some of the symptoms but don't actually stop the reaction. So epinephrine is a very important drug, old drug, but nothing else has ever shown this type of effect. We've had very strong execution since our launch in the first 3 months. We launched the last week of September. So we really have only had one quarter, but we've had a very strong performance, 50% of high decile doctors have already prescribed neffy and we've secured insurance coverage from one of the major PBMs, as I'll discuss and we're on the pathway to have about 80% coverage within the first year with a very good gross to net of at least 50% or greater. We believe this is a multibillion-dollar opportunity. The current prescription market, as we see it, is a $3 billion market. We believe the vast majority of that will convert to neffy over time. There is an expansion market I'll discuss that is up to $7 billion and we'll explain that in a little bit. We have NCE-like IP. So our patent families are two separate patent families, one based on composition of matter. It sounds unusual with epinephrine. But in order to get epinephrine absorbed, you need a very unique absorption-enhancing agent called Intravail, dodecyl maltoside and that combination is patented as well as method of use patents underneath that expand those claims. And we also have another patent family that has also been challenged and upheld by the IPR Board. So it's a very strong patent family, where we protect the dose in any nasal epinephrine product below 4 milligrams would be blocked by that patent family. Finally, we believe that this is really a market or a product type that has good precedents like NARCAN, Valtoco, Nayzilam in emergency medicine, where those products have more or less taken over the market from injection or other routes of administration because in these emergency situations, nasal administration with this device is very, very easy, very rapid, very effective. We're also in a very good cash position with more than $300 million in cash, no debt at the end of 2024. So we're in a very good position to accelerate the launch of neffy. Why is this important? Believe it or not, after 40 years of EpiPen, there's still a tremendous unmet medical need in this indication. People don't carry their devices. Auto injectors are bulky. They're large, hard to carry. People don't carry them, about 50% based on the literature, don't actually carry their device and only 20% carry 2. So that means you really -- 10% of the time, you're going to need a second dose based on literature. So you really should always carry 2 devices. And with neffy, we basically have a carrying package that's basically this small, it's about half the size of your iPhone, and it always carries 2 and has the instructions and a QR code to go to a video to remind yourself how to use it. So it's -- this is basically how people will carry around neffy, at least they can carry around in anything they want, but this is how we promote to carry it. So neffy is small, easy to carry. So that's a huge advantage right away. The other is people refuse to inject. And it sounds remarkable. You're having a life-threatening event but they don't want to inject. They literally will go to the emergency room with the EpiPen in their hand, and non-inject. And that's not the way this disease should be treated. The earlier you treat this disease, the faster you stop the reaction, the less comorbidities, less risk of serious hospitalization or even death. Even though death is rare, still you're putting yourself at risk. So the sooner you administer epinephrine the better. So by taking away the needle, taking away the fear, making it easier to use the device, people administer the product more often and they also administer it faster. They don't delay letting the disease progress. Finally, auto-injectors, people make a lot of mistakes with them. They're complicated. Sometimes they don't work. They have a long history of failure, vice failure, which puts the patient at risk. This device is the same device as used for NARCAN. It's been proven very reliable in laboratory testing more than 99.999% reliable to deliver an effective dose. In real practice, I think NARCAN had 1 out of 3 million reported device-related issues. So that's amazing for a device. So it's a very, very reliable product. It's also in our formulation more stable than auto-injectors and especially at high temperature, which is a real benefit. And also not only for patients but also for commercial use, the higher temperature, having it stable at 122 Farenheit, 50 degrees C, is great for aeroplanes that sit on the tarmac. It's great for cars, police cars, if they're going to carry neffy, so it's a much better product to carry around and not worry about the stability and not worry about having to protect it from temperature. How do we see the population that we're trying to address. There are about 40 million people in the United States with this disease, okay? Based on claims databases, we believe there's about 20 million that have very severe disease that have had anaphylaxis in the last 3 years and or been diagnosed. And that's really the addressable population that probably should have epinephrine. Of those people, there are 6.5 million that actually have received a prescription. Now whether they filled it or not is a different story but when you talk to allergists, they'll tell you, "I'm going to give a prescription to anybody at serious risk. Can't force them to go fill it, but I'm going to give it to them, even if they tell me, I don't want that auto-injector. So the 6.5 million people have received a prescription in the last few years, 3.2 million actually have auto-injectors. So there's 3.3 million people who didn't fill their prescription or didn't refill. The vast majority, we believe, is because they don't want a large bulky injector. And those people may much prefer neffy. So we see this as converting the 3.2 million. We believe that more than 80% of the population will convert to neffy over time and that's similar to the analogs, the combination in epilepsy, the combination of Valtoco and Nayzilam are now at about 80%, NARCAN is at 95% of the market. So nobody uses injection anymore, even emergency rooms have switched to nasal. So we believe that over time, that 3.2 million will convert. We also believe that we can recapture a large percentage of the 3.3 million people that refuse to fill their prescriptions. And again, because a lot of them didn't carry it around, they didn't want to deal with it, a lot of them refused to inject and we believe a lot of that population will come back. That 6.5 million at our gross to net is a $3 billion market, okay? In addition, there's 13.5 million people, the vast majority of them do not go to allergists, only about 2% based on our research are visiting allergists. 13.5 million people that have this disease have been diagnosed with anaphylaxis, have been in emergency rooms with anaphylaxis and don't go get epinephrine. Don't go see an allergist. We really want to bring those people into the market. 10% of that population would be $1 billion in sales. So you could see it's a potential $7 billion expansion, but even just 10% would be $1 billion additional sales of neffy. We've also taken a global approach for a small company, I think it's really an achievement maybe unusual, but a real achievement. We pursued neffy simultaneously in U.S., Europe and Japan. We now have approval in the United States from the FDA. And shortly after, almost at the same time, the European Medical Agency approved neffy. So we are approved both in U.S. and Europe. We have also filed in Japan and I'm sorry, in the title here, we left out Japan, so no offense. But we've filed in Japan, we filed in China. We have filed in Australia, and just recently, U.K. and Canada, okay? For the world, ARS is marketing in the United States. We have a European and worldwide partner. So all the blue is ALK. ALK-Abelló has licensed the product and it was a really, really positive deal for both companies. It gave ARS a very large cash infusion to market neffy in the United States. ALK is a very well situated allergy company in 65 countries around the world. And it also -- for ARS as a small company, means we didn't have to license all these separate regions, India, Middle East, Africa, South America to all different separate companies. We have one partner that we can deal with that can manage marketing in all of these countries. Also in China, we have a partner, Pediatrics, pediatric-focused company that will be -- that is filed in China, and hopefully, we'll get approval later this year and be able to launch the first out-of-hospital use epinephrine product in China ever. There are no auto-injectors in China. They have never been approved in China. So this will be the only community use product in China. And then Japan, Alfresa, who is the company that markets or distributes EpiPen in Japan and then CSL in Australia, the largest pharmaceutical company in Australia and New Zealand license it in Australia. So this gave us $570 million in milestones both upfront and sales milestones to really fuel our marketing in the United States. So where are we? And we're not going to really focus on ARS as a company, per se, but just where are we in the commercialization of neffy today? So as I said, we launched the last week of September. I would say it wasn't really in pharmacies until maybe middle of October. So we're only talking about a month of sale or 3 months of sales in 2024. Where we're going to focus in 2025 is really on educating the prescribers, getting them comfortable with using neffy because, again, 40 years of using an auto-injector, there's always a transition with any new product and they got to get comfortable with the new product that it's going to work the same that patients are going to like it and then they start really picking up the prescriptions. So we see a lot of the big prescribers are giving some of their patients neffy, maybe test cases or those patients they know are really serious and refuse to inject, they switch them over and then over time, they get more comfortable and I'll explain how we're getting them more comfortable more rapidly, how we're going to focus on that. The second is facilitating access, of course. In any environment, you got to get reimbursement, you want to make it as smooth as possible. So getting insurance coverage as quickly as possible is very, very critical. And we've been very successful so far. And we know that the insurance companies are seeing the value of neffy very, very clearly. So we're making very good progress there and I'll talk a little bit more about that in a minute. And then middle of this year, the rest of the year, we're also going to focus on really raising awareness. We're going to start a very large direct-to-consumer campaign in May before schools out so that when the kids come out of school, there's a huge increase in prescriptions over the summer for children. There's about 30% overall sales in the summer, but for kids, it's about 50% of the prescriptions written over the summer when they're out of school, they got time to go to their allergists. So we're -- and they're also getting their prescriptions to go back to school the next year. So we're going to really launch a very robust DTC campaign in May, so that they are very aware of neffy before they finish school and over the summer. And then we're going to try to reach more prescribers. We're going to expand out from those high decile allergists and pediatricians to other doctors that treat this disease and write prescriptions, even general practitioners, not necessarily through sales force visits because it could be too many doctors, but we're going to be getting to those doctors through our marketing efforts. We are launching CME programs and other efforts to get to those doctors to get them more aware of neffy. So where are we? First quarter of sales was about $7.1 million, so since September 23. It sounds like a small amount at first, but first few months, it's actually very good. Compared to analyst projections of $4.1 million, we did very well. But also our internal projections which were done by objective insights, which is the basis for our budget. When we give you financial guidance forecast, it's really based on objective insights forecast, they're an outside kind of very well-known, very well-respected company that does forecasting that we hired. And they predicted $3.4 million in the same period. So we're really doing much better than what would be anticipated. And we think that's also because of the great demand for this type of product in the community. So how are we going to continue to drive this demand? We need to educate doctors. We need to educate patients. And part of that is through our sales force and our other marketing efforts. We have 118 in our sales force right now out there in the field. We're visiting -- targeting first around 4,000 high prescribers. There's about 4,000 allergists and pediatricians that are in our list that are really in the top tier, deciles 8 to 10. And then we'll also have a total reach of about 12,500 health care providers that we'll be visiting throughout the year. In addition, we're running a program, again, to get people and doctors comfortable with neffy, we knew this was going to be a challenge at the beginning from our market research. So we started a program very early on, really almost at launch called neffy experience. The idea of neffy experience is we're going to give doctors the two oral challenger immunotherapy in their clinics and they have patients that react and they need to use epinephrine and treat them in the clinic. We give them some neffy, not to give to the patients but to use in their clinic. In that way, rather than mom and dad coming and saying, "My child hates the injector, I really love this idea. Does it work the same as injection?" Rather than a doctor saying, "Well, the data looks okay. FDA approved that it should work the same, but I'm not really sure." The doctor now can say, "Yes, we've used it in the clinic and it really works the same. I can't tell the difference from injection." And that's a different message that the patient or the caregiver will hear. So that's why we're running this. It's actually expanded. It's so popular with the doctors that we now have 1,750 doctors out there with neffy, treating patients in the clinic to get that experience and build that confidence. And of those doctors now, and again, it's expanding rapidly, so it's kind of the tail, but already about 70% of those doctors have prescribed neffy. So it's really a very effective program and we're going to continue to expand it. We have to facilitate access, right? So we -- our net price is about $710 and we have a co-pay assistance program to try to bring the price down for most commercial buyers, most commercial customers to $25. Just to give you a sense of what that means, auto injectors, generic auto-injectors today on average are a $40 copay. So neffy is actually cheaper for those commercially insured than auto-injectors. In addition, we have a cash pay price of $199, which is the same as auto-injectors. So there's no price barrier to get neffy for the customer, okay? At the same time, the insurance companies and PBMs have really recognized the value of neffy. The value of the patient carrying it, using it sooner, avoiding emergency rooms, avoiding hospitalizations, they're really positive about it. So Express Scripts signed a deal with us, put it on formulary Tier 2 preferred, $40 co-pays or buydown's only about $15 in 9 weeks after launch. That's really fast for a PBM. The other two PBMs we think will have on board by the end of this quarter. They're ready. They're very close to agreement. So we'll have at least 60% coverage by the end of March, by the end of first quarter, and we're targeting to have well over 80% by the end of the 12-month period ending in third quarter. In addition, these contracts are very lucrative. They're very positive to ARS. We're contracting in a way that are gross to net and this includes everything. This includes the discounts. This includes the fees, distribution, pharmacy fees. This includes our co-pay assistance program. Our gross to net is still 50% or greater in any of these agreements. So that's really an innovative product gross to net and we were really -- had a lot of skepticism from investors and also even pharma companies that we could get that kind of gross to net with this type of product. They really thought we would be treated like a generic and it's very clear that were not being treated like a generic. So we also want to activate the patient population. We're doing this through partnerships with advocacy, of course. There's some really strong advocacy groups in the United States. But also, as I mentioned, starting a DTC campaign in second quarter. We think at that point, we'll have very good access. We'll have very good insurance coverage. We're going to start to really put a lot of money into this. And again, because of our cash position and our partnership deals that we did, we really have the cash to spend on DTC and really blow this out in 2025, and get this product moving fast. And that's what we're planning to do. In addition, we're also, obviously, as I mentioned, trying to make sure health care providers are comfortable. We're working on CME programs. We're expanding our sales force. We anticipate by 2026 to expand our sales force up to 200 sales reps, plus area of sales managers, so it will be probably in the 220, 225 range. And we think that will really expand our reach to a vast majority of the prescribers. And then recent surveys we've done some more -- we've done a lot of market research over the years. More recently, we've done another survey after launch just to get a sense of how doctors are feeling about neffy. And what we're finding is that neffy will very quickly become the product of choice for these doctors. They're very quickly, about 1/3 of them are saying already, it's their product of choice. So new patients coming in, they're going to offer them neffy first, patients as they come in for their annual visits, they'll offer them neffy and convert them from injection to neffy, especially those patients that are reluctant to use auto-injectors. Over time, when they get more experienced, they say they're going to make neffy the product of choice to where more than 90% of doctors are saying, this would be the preferred option for them once they're comfortable with the product and its performance. In addition, when we survey them, what are the barriers? We want to know what the barriers are because we need to address those and that's what I've been talking about. So cost and coverage, obviously. Doctors, we're getting very high rates of prior authorization approvals from the insurance companies, over 50%, 55%. But doctors hate the right prior authorizations. They hate to deal with it. So it's a barrier. So we need to clear that out. We need to get that formulary coverage. There are no step edits. There are no restrictions from these insurance companies. There are no restrictions on the quantity of prescriptions you can get. People have already been getting approval for three prescriptions at a time, some people will want more. So again, you want to have neffy positioned in many places, Mom 111, Dad 111, School of that 1, people in their grandma, pick up the kids after school. So $25 of prescription once it's under formulary, once it's a Tier 2 preferred will be no issue for a lot of these patients and caregivers. In addition, we focused on clinical experience because, obviously, that is one of the top things doctors are saying, they want to make sure it's going to work the same. They want to have comfort. They want to see it in the community setting work and we're getting reports all the time. In fact, this morning, we had an e-mail from mother of a daughter in college who had neffy was terrified to use injection over the years, had a reaction on -- called her mother on the phone, took the neffy, 5 minutes later, she was already telling her mother, she's okay. So those kind of stories really is why we develop neffy, that's really the type of patient we like to hear. And then what do we do next? So over the years, you think what epinephrine, it's only used for allergy reactions, but that's not really true. We talk to the docs, the allergists from a long time ago. Epinephrine was used for asthma. It was used for urticaria. And we still see a very, very strong market in urticaria. And this is not chronic urticaria. We're not talking about chronic treatment. We're talking about patients with chronic spontaneous urticaria who are on either antihistamine therapy or on biologics, XOLAIR right now, who have exacerbations. They have what's called a flare. So these exacerbations can last for days and they could be very serious. And even in the XOLAIR Phase III trials, patients on average went to the emergency room 3 to 4 times a year because of these exacerbations. So why epinephrine? Well, epinephrine is exceptionally effective at controlling those symptoms and stopping the reaction at stabilizing mast cells and stopping reaction. We've already done a Phase I study where you see very rapid effect on itch and hives with epinephrine. We're starting a Phase IIb study in the first quarter of this year to do an outpatient study and get a little bit better idea dose because we didn't have a difference between 1 mg and 2 mg. We may go down a little bit in dose and look at even a lower dose and get a really good assessment using our outpatient self-assessment tools of the effect size so that we could power a Phase III study. FDA has already told us we just need one Phase III study for approval in this indication. It's the same mechanism of action as food allergy. So we just need the one Phase III study. We anticipate starting that Phase III study in the beginning of 2026, probably take about a year, and then we'll be in a position to file. This is actually an unmet medical need. There's nothing to treat these flares right now. Patients go to the hospital, get IV antihistamines, IV steroids or they take a steroid, which might take hours to take an effect. So there's nothing to treat this that would be rapid like this and give them relief in 20, 30 minutes and stop that intense itching because that really what is going on. In addition, these people also get angioedema of the face. Sometimes they're becoming antisocial. They don't want to go out. Epinephrine's exceptionally effective at reducing that angioedema and making them more comfortable to go out, go to work, go to school. So this is, we believe, a $2 billion to $3 billion expansion market in this indication. Smaller population but they'll use the epinephrine much more often. This will be a different brand because it will be a different dose. So we don't want it to be confused with food allergy dosing. We don't need blood pressure, heart rate increase here, which we prefer in food allergy, so the dosing of food allergy is going to get your blood pressure and heart rate up as well. In urticaria, we just want the mast cell effect. We want to stabilize the disease. We don't need to see a lot of blood pressure, heart rate increase. So we're going to go to the lowest effective dose we can find. So that puts us on a really good pathway, we believe, we think we started out fairly well, good foundation, great acceptance in the community. We're looking forward to the biggest meeting of the year AAAAI, American Association of Asthma, Allergy and Immunology coming up in the end of February, be the first-time neffy's commercial at that meeting. So we're looking at a really big meeting for ARS. And then in 2025, I said we're really focused on accelerating this. I'm getting the doctors comfortable, make raising awareness and moving this product forward as quickly as we can, expanding the use as much as possible. 2026, continuing, expanding our sales force and focusing on other indications as well as neffy sales and food allergy and venom allergies. And we believe that this could lead to a really blockbuster drug and moving in that direction. So we'll take any questions. Thank you very much.

Could you touch a little bit about the addressable market already but could you just speak a little bit to which specific patient demographics or the focus of initial commercialization efforts?

Yes. I think it's really a little bit broad because we're seeing patients from all the demographics come in. But I think initially, the doctors are focused on switching patients who are auto-injector users who are refusing to use it or reluctant to use the auto-injector because those are the people at biggest risk. They're also focused on those patients that refuse to get an auto-injector. In fact, yesterday, we spoke to an investor who is the patient who never got an auto-injector, she would never use it. So she never actually got -- she was given prescription. She's actually in that demographic of the 3.3 million. And she asked that is she the main demographic coming in. And we said, "No, we don't think so, but you're the expansion demographic. So it's great you're getting neffy and she got her neffy and she was really happy about it. So again, that's the kind of person you want. She's the one that refused to get a prescription and now she's willing to get neffy. And that's really showing there's the potential. So -- but I think the docs are really concerned about those patients that showed up in the emergency room last month and refused to inject. They had their auto-injector and refuse, and that's the ones they're focused on and willing to take their time to do a prior authorization or get them back in the office quick and get them switched over.

Great. And I guess along those lines, related to the launch, have there been any unexpected trends, any challenges? And then how should we think of the ramp to our peak sales?

Yes. I don't think so. I think the only struggles we had in the initial launch where distributors were -- are very cautious these days. So we did have a little bit slower pathway getting into the pharmacies a little longer than we had first anticipated to get the distributors to get it out to the regional distribution centers and into the pharmacies. I think that's all solved now. And I think the only other thing we pondered about for a long time until we checked with some other companies and other experts at this is that we couldn't understand the mismatch between our sales data and IQVIA sales data. So all I can tell you is IQVIA is not that accurate in the first 12 to 18 months, and that's what we were hearing back and that's what we saw. So that's why I think some people were looking at IQVIA data and underestimated what they -- what our sales were, but we were also struggling with that for the last 3 months.

I'll pause here to see if there's any audience questions.

Would you have any additional data [indiscernible] you're going to highlight?

Yes. I believe so, I think we have, Serena, how many publications?

[indiscernible].

Yes. 8 abstracts and one oral presentation. Yes. Yes. So we also have one oral presentation in 8 abstracts at AAAAI, which will be additional data. Some of it we've alluded to or disclosed, but I think the oral challenge study in Japan, again, working with multiple regulatories, they all ask for something slightly different. So we've done a fairly broad range of work, but we did do a study in Japan where we actually treated people having reaction, children after oral challenge. And that was -- the Japanese regulatory authorities were PMDA were fine with PK/PD, but they said we just have to see a patient treated and see that it works in a patient. So we had -- it was a small study, only 15, but it was 15 out of 15 responds. So not too bad, and that was convincing for the Japanese authorities.

Yes. Two quick questions. One, can you speak a little bit more about how things are going on the channel, pulling things through at the pharmacy level, avoiding pharmacy switching to generics, et cetera? And secondly, can you talk a little bit more about the competitive landscape that you see in front of you?

Yes, yes. So with the pharmacy, I mean, as I said, there's a little lag in getting into the pharmacies with the distributors. It seems to be solved. We're not getting complaints from customers anymore about not being able to find neffy at pharmacies. So that part, I think, is not an issue at all. I think there can't be switching with this product. It's a different product class. It's a different route of administration. So there's no way for them to switch it legally. They can switch auto-injectors. If you have an EpiPen prescription and go to a CVS, they may switch you for [indiscernible]. So they can switch that. But with a different product class like this, doctors writing neffy on the script, there's really no legal way for them to switch it. It's not interchangeable based on Orange Book listing, so they can't really switch legally like they can an auto-injector. So we've seen none of that happening. And then the competitive landscape, I mean, personally, there's a couple of products out there, a few products out there that are attempting to match what we did. There's a couple nasal products that are still out there. We do not really believe that they're competitive. The one is a very, very high dose, causes a lot of nausea, a lot of other problems with it. It's actually a dose that's very high and potentially lethal. 13.5 milligrams of epinephrine and then there's a buckle, which I think is a good idea, but I think also has some challenges. And I think the buckle, we will see how FDA handles it, but they also do not match what we've been able to match and what the criteria FDA set for the development of neffy is that both on PK and PD that we were in the same range as injections. So we had to be on all pharmacokinetic parameters, AUC, Cmax, Tmax, we had to be in the range of injection products that are known to be safe and effective. Now what's also just one point in that, if you give it with IM needle syringe or you give epinephrine with EpiPen, they're equally effective. The doctors can't distinguish between the effectiveness of those products. They're both effective within about 5 minutes, you get effect. Sometimes you need a second dose, but both products need a second dose about the same amount, about 10% of the time. So there's really no differentiation between them. So the pharmacokinetics don't necessarily matter because they have very dramatic differences in pharmacokinetics. But what FDA was always worried about is if you're not at least as good as IM needle and syringe, you might not be efficacious. So you had to be at least as good as the IM needle and syringe, but you couldn't be more than EpiPen because either on 1 or 2 doses, we're bringing patients into a clinic that are healthy. These are very healthy people. They have no cardiovascular issues. We screen them for comorbidities. They're not on drugs. They're not having a reaction. They don't have asthma. So healthy people handle adrenaline really well. You can give a lot of adrenaline to a healthy person. When you talk about the real-world population, you don't know. So the only way we know that neffy is going to be safe is that we know we have 40 years of experience with EpiPen and you have 1 or 2 doses of EpiPen, we know that there's a certain safety profile of EpiPen. Now there can be serious events, but FDA's view was EpiPen is safe enough to use. So if you either or under the exposures or under the Cmax and AUC of EpiPen or IM, there's a question about efficacy. If you're over the exposure of 2 EpiPens or 1 EpiPen or 2 EpiPen, 1 dose or 2, there's a question about safety in the real world. And the question is how do you address that? And that was always a challenge from FDA to us. And they basically said, you just have to be in that bracket or we can't be sure if we're going to need additional work to figure out if it's safe or effective. And we were able to stay in that bracket even under nasal allergen challenge conditions. So we had to do nasal allergen challenge. And just so people know, I mean, I'm the one that got NARCAN approved. I got Valtoco approved. [indiscernible] back there did most of the clinical -- all the clinical trials with Valtoco. We've never seen FDA challenge a nasal product like this before, okay? We had to do self-administration, caregiver administration. We had to do nasal allergen challenge where we literally spray antigen into somebody's nose to make them have a severe allergic reaction and then show that the pharmacokinetics still met that profile. And even then after an advisory committee said, looks great. We think it should be approved, fairly overwhelming. FDA still said, no, one more, just one more time, one more study. We weren't too happy about it, but we did it, came out very well and I think they were very comfortable. And the only thing I could refer you to is Kelly Stone was a very challenging person. He's the Head of Allergy at FDA, Head of the clinical group, very challenging, really wanted to be sure about this product. I could refer you to the FDA's press release, which we had nothing to do with. We didn't see it before they released it. They don't let you see them anymore. And I have to admit he was as positive about this product as we were. And his quote and his positioning of neffy in the FDA's press release, I think, could be our marketing group messaging. So with everything make challenges on over the years and how careful they were, I think they came out on the side that this is really a positive product and they really promoted. I think that's why we also -- if you saw the media attention we got right after approval, I think that was partly driven by the fact that FDA put out such a positive position on the product.

Great. Yes, we only have about a minute left. So time for a quick question.

I know it just kick off, but what's the interest of been with the [indiscernible] and then with the lower dose, would that be important...?

Good point. So as part of our summer launch here, DTC launch, we're going to have the 1 milligram available in the market, okay? So FDA is well on track. They've had the study report for 18 months in the IND. So they've seen the study for a long time. We didn't want to compromise the NDA by filing it earlier, would have slowed things down. So they wanted to just prove 2. But we have a March 9 PDUFA date. They gave it priority review. They want the 1 milligram out there. They don't want younger kids using 2 milligrams. So they really want the 1 milligram dose. So we'll have it out there. We anticipate about 8 weeks to launch. And so we'll have it there by May when we start that DTC campaign. That's about 15% of the market, that population, 15 to 30 kilogram kids. But we'll now cover all the school kids. Now neffy in schools, amazing interest. I mean we have had nursing school nursing associations from literally almost every state. We're doing webinar training for them. We did one last month. They blew up the Zoom. It was over 1,000. We couldn't handle more than 1,000 on Zoom. We're doing another one next week that I think we're enrolled to about 1,250 nurses already. They are very, very interested in bringing neffy into the schools. They're already seeing neffy in the schools now with kids, and they really need to get ready and prepare. So it's really huge interest with neffy. And we anticipate having neffy in every single school in the country pretty quickly next year.

Great. Well, thank you very much for a fantastic presentation.