Thank you very much.
I'll just briefly, I'm Lachlan Henry Brown, one of the research analysts here at William Blair, along with my colleague Matt Phipps. We cover ARS Pharmaceuticals. Before I hand it over to Richard Lowenthal, the President and CEO of the company, did want to just mention, please visit williamblair.com to see any and all relevant disclosures. With that, I'll pass it on to Richard. Take it away.
Thank you very much. Pleasure to just talk a little bit about where we are at ARS Pharmaceuticals with the launch of neffy, which is our epinephrine nasal spray product that we hope will eventually replace all the injectable products that are out there in the market. All right, forward-looking statement. Obviously, neffy, we believe, is fairly transformative in this marketplace. It's the first FDA-approved needle-free, no needle, no injection solution for treatment of emergency type one allergic reactions, including anaphylaxis. We have both the 1 and 2 milligram product approved. We cover pretty much the entire market from 15 kg children to adults. We have good sales so far, strong execution to date. We reported in the first quarter, $7.8 million net sales. That's only our second full quarter after our launch. Things are progressing very well.
I'll talk a lot more about that as we go forward. We believe that this is a fairly large market opportunity. We believe that the existing prescription market, which is about 6.5 million patients that have received a prescription in the last three years, is about a $3 billion market at our net. In addition, there's a very large population out there that has not received a prescription. Typically, they do not visit allergists. They're with other doctor types that are not well educated on anaphylaxis and epinephrine, or they've been diagnosed in an emergency room and never seeked additional medical help. We believe that that's an additional expansion market.
On top of that, the potential for neffy to be used by institutional organizations where auto injectors would not typically be used because of the need for training and needle, which can be hazardous to the actual user, to the caregiver, or a good samaritan. Neffy opens up the opportunity for much more institutional use than the current auto injector market has in it. We have NCE-like IP protection out to 2039. We have very good patent protection. In fact, one of our patent families was recently challenged. It was upheld by a full IPR board and an appeal. Both upheld the patent. That just shows, and that was probably our weaker patent family, and it was upheld. It gives us a really good runway. We believe this is really transformative. We have a very good team in place.
Many of us on the team worked on Narcan and Valtoco, where Dr. Tenimoto, our Chief Medical Officer, and I worked on Valtoco and got Valtoco approved for epilepsy and other nasal spray for emergency use in epilepsy. We have a lot of experience in this field. If you're not familiar with anaphylaxis and type one allergic reactions, it's a systemic reaction. It can be very severe. Typically, it manifests itself as significant urticaria, hives and rash, angioedema, swelling of the face, lips, and tongues, especially. That can be very severe, very difficulty breathing. You can't inhale. You're having bronchospasm. A lot of people also get gastrointestinal disease or symptoms where they're vomiting, nausea, vomiting, and severe pain. When we think about the symptoms of an anaphylactic reaction, really a nasal spray is one of the best routes of administration next to injection.
When we think about the difference between other routes of administration and these symptoms, spraying something into your nose, like with Narcan, you do not have to be breathing. It is absorbed passively. The breathing difficulty is not an issue. The urticaria, the hives, not an issue, and vomiting is not an issue. Right? If the patient is vomiting from swallowing an antigen that is very upsetting to the stomach, it is not an issue to spray a nasal spray into their nose. We believe that this is ideally one of the best routes of administration for epinephrine. Why is it important? The current market is really not well utilized, the current products on the market. Only about 10%-20% of patients actually use their auto injector properly. That is well demonstrated in the literature.
Around 50% of people don't carry even one auto injector, and only 20% carry two. That's very well documented. People just don't carry them. Having something small, and you see the case here, I've got it in my pocket. It's pretty easy to carry. We put a clip on it so it can go in a backpack or in a purse and clip so you know exactly where it is so you can get to it quickly. That's one of our options for carrying it. Carriage is extremely important. Neffy being much smaller, easier to carry than auto injectors facilitates that carriage. That's one thing we want to promote.
The other thing that's remarkable is that even people that are carrying their auto injectors, when they have an anaphylactic event, only about half of them, 25%-60%, but on average in the literature, it's about half of them actually use it. What happens? They go to the emergency room. They have it in their hand. They won't use it. They don't inject. They just panic and go to the emergency room. They're really scared to inject themselves or their child. It's one of the big problems because if you're not willing to use the auto injector, obviously, it's not helping. neffy, we believe, is going to be much less intimidating, much easier for people to use. In addition, people delay. The other factor here is that if you delay treatment, your symptoms progress, you get much worse.
We believe neffy will be used much sooner, much more quickly, and stop the symptoms much sooner, and people will have less comorbidities. Our device is very, very reliable. We use the same device that Narcan uses, Valtoco. I think there's nine products on the market now with this device. It's super reliable. Imitrex for 20+ years has used this device. It's very, very reliable. Does not require training. As you know, Narcan is OTC. No training is required. We do facilitate training for school nurses and other organizations, but there's no training that's really required for neffy in the labeling. Again, looking at this population, when you look at epidemiology, there's about 40 million people in this country with the disease. 10% of the population, more than 10%, has this disease.
We believe, based on claims databases, there's really about 20 million that have serious disease that probably would benefit from having epinephrine. Okay? And when you drill down, there's about 6.5 million of these patients that visit allergists. And almost all of those have been prescribed epinephrine. Okay? So they get a prescription, whether they fill it or not is the question. But when you talk to an allergist, if you come in and you have this disease, you have severe anaphylaxis, they are going to give you a prescription. Even if you tell them you don't want it, they're going to give it to you for liability reasons, and you can fill it or not fill it. Unfortunately, as you could tell, only about half the people fill their prescriptions. So there's 3.2 million people that fill their prescriptions.
At our net, that would be about a $1.7 billion market. We believe there's potential for that market to grow. Initially, the 3.3 million people that don't fill their prescriptions, vast majority of times, they're not filling them because they don't think the auto injector is convenient. They don't like the idea of injecting themselves, and they think they can just avoid the antigen. A lot of allergists tell us that neffy gives them a second shot on goal, a second opportunity to go back at those patients and get them to get epinephrine as a nasal instead of injection. The first stage of expansion of this market could be getting those 3.3 back into the market. They're already visiting allergists, the right type of doctors or pediatricians that are also prescribing epinephrine pretty readily.
We believe that together is a potential for over a $3 billion market. There is the 13.5 million that are mostly not with allergists. We have done a lot of work to look at this population. Less than 2% are visiting allergists. They are visiting general practitioners, OBGYNs. Largely, about 20% of this population was diagnosed in the emergency room, never went to a doctor after that. They just went to the emergency room with anaphylaxis and got treated and left and decided, "I'm not eating that again." Hard to do. That is another potential expansion population where we really believe they are not aware. They are not aware of the need for epinephrine. They are not aware of the need to go visit an allergist.
As we get out there with our public service campaign with FAIR, with our DEAG, some of those people back into the market as well, or into the market. They've never been in the market. We are going to hopefully expand the market. None of this includes also institutional use of neffy, which, again, when you take away the needle, the need for training, you make it much easier to put epinephrine in public places. We believe there's another opportunity for expanding the market there that is maybe some analysts called it blue sky. They do not know how to assess it yet, but they call it blue sky opportunity. We have also partnered neffy all over the world. We have approval in Europe, as you probably are aware. We are pending approval in the U.K. very shortly, maybe this month, maybe next month.
Depends on if they have any more questions, but we're otherwise pretty much done in the U.K. We should be approved there soon. We also anticipate approval in Japan and China this year. Australia, possibly this year, but most likely next year in Australia. Now, when you look at our territories, we have what looks like a huge part of the world licensed by ALK, but obviously the only real important parts of the world that ALK has are Europe, U.K., and Canada. That's the vast majority of the world market in addition to the United States. Japan is a company called Alfressa. They're about an $8 billion Japanese conglomerate, pharmaceutical, pharmacy, distribution, everything. They also distribute EpiPen in Japan. That's why they wanted neffy because they know this market. In China, Pediatrics, and Australia's CSL, who's the largest pharmaceutical company in Australia.
By next year, we should have approval worldwide with neffy and launching worldwide. We are expecting to launch this summer in Germany. Once the U.K. is approved, ALK will launch very quickly. They are being very careful with pricing because they want a premium price in Europe for neffy. They will roll it out in the higher price countries and get those prices. There are some countries where they may never market neffy because of the pricing. Commercial progress, just as I said, one and two milligram are approved. The one milligram was just approved May 7th. We literally just launched it and have a few weeks in the marketplace so far for the one milligram, but we expect that to be a big contributor. It is about 23%-24% of the overall market is that population of 15- 30 kg children.
In the beginning part of this year, we've really been, since the launch, we've really been focused at educating prescribers, educating the doctors about neffy, getting them comfortable to adopt it, and then facilitating access and getting insurance coverage. Right now, we'll talk about this a little bit more. We're at about 92% commercial coverage where companies will cover neffy. About 57% of that, or 57% overall, is not requiring prior authorizations at all. It's just automatic. You just get the prescription, go to the pharmacy and pick it up, and it's covered. The difference is still requiring a prior authorization. We're trying to clear that out. Very few insurance companies are not covering neffy or blocking it at this point. Okay? We believe that that will improve over time. Obviously now, starting now, we're just starting up our direct-to-consumer campaign.
This is a pretty big spend. We're looking at about $45 million this year. For the rest of this year, it's probably on an annualized basis, close to $100 million spend for DTC. That's benchmarked against very similar products like Trilogy, Mibo, I think, but benchmarked against those types of products, which are really very similar. They're very large populations, consumer-based, consumer decisions, deciding which one they want. Allergists are very heavy into shared decision-making. They're going to put all the options on the table in front of you, and they want you to choose. The reason they believe that's very important is that if you choose this option, they believe you're going to more likely carry and use that option. That's their shared decision-making approach. We believe driving, at this point, we have the access that we wanted.
Driving the patient awareness and patients to go and ask for neffy is very, very important at this stage. That is why we've moved up and expanded our DTC campaign to push that. We're getting very strong demand so far. We have about 5,500 doctors that have already prescribed neffy to date. A lot of that is with the higher decile allergists who are adopting neffy very, very quickly. Okay? We expect that to continue to expand. We also have our neffy experience program ongoing. One of the things you need to do with any new drug, as you know, is get doctors to kind of get used to it. There's an adoption phase, right? Where they trial it, they test it out with different patients, and then they see it's working really well, and people like it.
They start really ramping up the prescribing. We're still in that phase. One of the things we're doing to facilitate that is by having neffy experience, which is now in about 2,500 doctors around the country who do oral food challenge or immunotherapy. In oral food challenge immunotherapy, it's not uncommon that, especially oral food challenge, but even immunotherapy, people have an allergic reaction in the clinic. They have an anaphylactic event. They need epinephrine to treat them. Those 2,500 doctors now have neffy that they can use. We are going to put out a publication soon about a fairly large survey we've done where a fairly large number of patients have been treated. You'll see that it's working exactly like injection, exactly what would be expected for injection. Feedback so far is very positive.
We're hoping to now expand this program to include the 1 mg. We'll start to see little kids get treated in the clinic as well. We're targeting towards the American College meeting to have another round of review, a survey where we may have a couple thousand treatments by then, and to really show that neffy is working exactly like injection. That's really part of this whole adoption phase to get the doctors really convinced and comfortable that it's just interchangeable with injection. We've done some other more recent surveys of doctors since we've launched, and this is relatively recent. The two big barriers they're saying right now are cost and coverage, which of course is improving since we've even done this, and clinical experience. That's that real-world experience, not just the data we have, but real-world.
They want to actually see it work in the real world. So that's the neffy experience, and then just adoption, trial and error, which is going to occur over time. About two-thirds of doctors say that they would proactively offer neffy to their patients, that they're just going to offer it to their patients automatically. Nine out of 10 say if their patient comes in and asks for it, they'll prescribe it because, again, that shared decision-making. DTC is important here because we want to raise awareness, get the patients to come in and ask. If we ask them what they anticipate their market share will be in one year from the time we did this survey, they were saying about 50% of patients would get neffy. Okay. We're on track for broad adoption.
As we said, our list price, we have a very good access progress so far. I already talked about this. 92% commercial coverage, 57% without a prior authorization, but 35% requires prior authorization. Overall approval rates right now are about 60%. Some payers are higher, some are lower. We have some laggers with the Blue Cross plans that are a little slow at adopting, but we're working on improving this over time. Our overall gross-to-net retention is about 50%, a little bit greater than 50%. We are doing very well on our net on these contracts. We have all three of the major GPOs under contract. Ascent, MSR, and most recently, Zinc. You could see that it's not black and white in this world. Okay? There are hundreds of payers under these GPOs, and the payers each decide if they want to adopt the contract.
For example, with Ascent, we're at about 89% of the 130 Ascent payers under them are actually covering neffy or covering neffy, and 64% without prior authorization. With MSR, 88% are covering, 86% without prior authorization. They're doing really well. The Zinc group, which just started, so Zinc has just started, but 97% of their payers are actually covering. The majority are still requiring a prior authorization. It's only about 20% are approving without prior authorization, but the rest of them are still covering with a prior authorization. We're doing quite well at getting the insurers. Very few insurers want to say they want to block neffy or they won't cover neffy. They don't want to say that because it's very negative with this indication and this type of product. We're seeing that they're just, at most, they're requiring a PA.
Awareness is very important, and that's why we're doing the DTC campaign. We're putting the money into it. We're moving it up. I think we're doing a good job so far, but we're going to expand it. Over the next month or two, you'll see fairly significant expansion. Only about 16% of patients in this survey that we did in the first quarter of 2025 really know about neffy. That's really not good awareness, right? I mean, we would have expected it to be better than that because of all the publicity we got with the news and approval and everything like that. Really, only about 16% are aware of neffy without being told about it first. When they are aware of it, 81% of caregivers say they would want to get it. Focusing on the kids, the caregivers really prefer neffy, okay, for children.
Of course, the doctors, as we said, nine out of 10 said they would prescribe it. This is what our DTC campaign, if you have not seen it yet, but you will probably start seeing it. If you are on Connected TV, it has been on Connected TV a lot, but it is targeted. It is on social media. It is on other targeted media search. We are expanding more and more to linear TV, broadcast, cable TV. You will start seeing it on Fox, CNBC. It has already been on a number of times, but we will be increasing the frequency. Again, heading into the peak summer months. It is really based on a theme we have of Hello neffy, Goodbye Needles. Okay? The jingle, I will not sing it for you, but it is the na na na song from Hello Goodbye. There is a lot of it sung at a lot of sports games and stuff.
It's really about Hello neffy, Goodbye Needles, Hello neffy, Goodbye Anxiety, Hello neffy, Goodbye Hesitation. We really want to focus on that. We think it really is a good initial commercial. We're really happy with it. It's a little different when you see it. It's really jingle-oriented and really focused on empowering people, empowering moms. We believe it's a little different but memorable commercial, which is what we were after, something people will watch and remember. So far, it's going very well. This is just the first couple of weeks, really, of a DTC campaign. To get into linear broadcast TV, cable TV takes more time because you literally have to get credit checks. You got to do all these things to get in there. They have to check the commercial, make sure it's compliant with their rules.
The directed access to patients is a lot faster. We've been in there already. You're seeing, I'm not going to go through it all, but you see we're getting millions and millions of views of this commercial and impressions. We think it's going very, very well so far, but again, some time to go. It's all focused on back to school. The peak season for this market is really starting around now through the end of September with the two really big peak months of August and September. That's when the kids are going back to their allergist. They have their prescheduled appointments. It takes three, sometimes more, months to get into an allergist, but these are all prescheduled appointments the kids have. They're usually getting renewal prescriptions before they go back to school the next year.
That's why the peak is in this period of time. We're really focused on that peak period. We've got the one mg launch. That was very important for us to get that out there because it's 23%-24% of the whole market for the younger kids. We've got this broad DTC campaign starting. We have about 92% commercial coverage. Access, we're hoping to even improve that before the summer peak period, especially by getting rid of some of the prior authorization requirements with some of these payers. It's improving almost daily because there are so many payers making decisions. We want to expand our U.S. salesforce. We've done that by a deal with ALK-Abelló, which is our European partner, so ALK-Abelló. They have a U.S. salesforce also because they sell immunotherapy in the U.S., mainly focused at pediatricians.
We're looking for opportunity to expand our reach, especially in the pediatricians. We really just happened to start talking to ALK, and it just kind of came together that it was a really good deal for both parties to where it's very cost-effective for us to add another 10%. It's 63 sales reps, but again, you're drilling down into lower decile pediatricians. You add about 10% of the market with that. It's a very cost-effective way for us to do that heading into the summer peak period. That's really why we did that deal. I think it's a very good deal. It adds about 9,000 pediatricians that we can reach. We hope that will translate into a little bit of an increase in the market size also in our reach into those pediatricians over the summer periods.
Again, we also have our ongoing ErtaCarya program. We are now starting our phase 2B study. It is just starting this month. We hope to have a readout second quarter of next year as to how that looks and then move to phase three with ErtaCarya. Just to wrap up, I mean, we think we are making very good progress on the launch. We think this year is really focused on expanding the awareness of neffy and the comfort of doctors to prescribe. We think things will start to really accelerate and then intensify the growth next year. We believe we are heading towards our $3 billion potential +. Again, CSU is also another indication that could come in the next three years, which is another $2 billion-$3 billion potential market.
This is synergy with all the other therapies coming out because they're all being used as chronic therapy. neffy is for acute flares. The flare-ups that occur even when you're on Xolair and you have an exacerbation. neffy is really going to be used, we won't call it neffy, but nasal epinephrine will be used to knock down that flare and stop the symptoms to relieve the itching and hives, especially the itch is really what makes the patients go to the emergency room. We believe this is a really great product to help address that. It is synergistic with Xolair, with any other biologic coming down the pipe. It wouldn't be conflicting with that. It would be additive to that. That's it. Next, any questions? Sorry? The urticaria or the?
How does the device work?
Oh, the device?
The device is the same as we said. The device is pretty well known because it's not, we didn't want to do anything too novel. There were some cute novel devices out there, but this one just works super well. It's purely you just grab it, put it in your nose, and push the plunger. That's it. No activation, nothing else to do.
You push the plunger to fire it.
I'm not going to do that. This is a live one, so I'm not going to, this is real, so I'm not going to fire it. You just put it in your nose and push this plunger, and it fires. That's it. Yes. Yeah. This is manufactured at a facility in New Jersey, in a manufacturer, same place that makes Narcan, the same device. Huh?
The manufacturer in New Jersey loads the drug into the device. Yeah. Yeah. It's a small vial inside the plunger. They fill the vial, and then they load the vial and assemble the device. Thirty months. Neffy is approved with 30 months for the two milligram, 30 months. The 1 milligram has 24 months currently, but we think we'll eventually be able to extend it to 30 months. They vary from, I think, 18-24, 26 months depending on the product. They're pretty variable from product to product. Their degradation pathway is different than ours. It's because they use very high concentrations of metabisulfite. We don't. They degrade mainly by epinephrine reacting with metabisulfite. That is why they're very unstable at high temperature because that accelerates that reaction very rapidly. We don't have that issue.
We actually, our expiration is limited by racemization. So the L converts to the S in anthemers. And that's hard to stop. It's entropy. So we can't do much about that, but we've been able to solve for the heat stability because this is, it's another big advantage in neffy is it's stable to 122 degrees Fahrenheit. We've done studies for three months at 122 degrees Fahrenheit. It's still past spec. EpiPens are pretty heavily degraded in a couple of weeks at that temperature. You really don't want to leave it in your car by accident. It will degrade pretty rapidly with this. If you left it in your car, it's still useful. It's not something to worry about. Yeah, sure. I'll take one more. No, no, there's no IP on the device. Our IP is on two factors.
One, the combination of our absorption enhancing agent, which is the Desamaltoside Interval is a brand name. The combination of Interval and epinephrine, which is very unique, and that's a molecular entity patent. It is molecular entity, and then there's method of use patents as well in that family. The other family is on the dose itself because nobody's ever seen therapeutic levels of epinephrine at the doses we give intranasally. The patent office has given us a patent on four milligrams or below for any intranasal administration of epinephrine. That patent actually was challenged because it was blocking another company from pursuing a totally different technology because it's so broad. They did challenge it, and the IPR board upheld the patent, and then they went to an appeal, and they lost on the appeal in federal court.
We are pretty confident in that patent family because it's already been challenged and upheld. Again, it's on any intranasal administration of epinephrine at four milligrams or below. We don't think FDA would approve a higher, FDA normally doesn't like higher dose for no benefit and no reason. We don't think FDA would approve a higher dose intranasal spray. Somebody would have to come up with a way around our patent, which I think is very, very difficult. We really block other 505B2 nasal sprays, in fact. Ready?
Okay. Thank you, everyone. We've got a breakout now in Burnham B. Thanks, Richard. Great.
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