... All right, I think we're ready to get started. Welcome, everyone. I'm Josh Schimmer from the Cantor Biotech Equity Research Team. Our last company session of the day, going out with a launch story of a very unique product profile. We have ARS Pharmaceuticals' management team, Richard Lowenthal, President and Chief Executive Officer, and Eric Karas, Chief Commercial Officer. All right, frame for us where we are in the launch of Neffy as you're looking to displace the injectable epinephrines. Okay, so we're about 10 months into the launch. So we launched in October of last year, and focused mainly, obviously, access at this stage. I think we're doing well. We've got a couple large players out there we're still trying to convert from being requiring prior authorizations to open access, unrestricted. And then, obviously, we just recently initiated a DTC campaign, so that started off, you know, really in June, let's say mid-May, beginning of June. And then the linear TV part of that started in the beginning of July 'cause it takes an extra month to get approval from the networks, from the broadcast networks and cable networks to get on the linear TV, so that started in July. So we'd expect to just now start to see real uptake from the DTC campaign. And we're doing a pretty robust campaign. Hopefully, you've seen our commercial, and you like it, or it's annoying and then that's actually not positive. I've had a few emails where one lady was like, "Please stop it." And I'm like, "Okay, it's working. It's out already. But no, but some people say they like it, and some people... Well, most people say they like it, actually. I think the vast majority of input we've had is it's a good commercial. It's a little different. We wanted something a little different, and we think that's a big part of this market. I mean, doctors, almost exclusively, almost 100%, no matter who did the research, whether it's independent research from analysts like Josh or it's been our research, typically comes back in the 98%-100% of doctors say if a patient asks for Neffy and says they prefer this, that they would prescribe. And so that's important to get awareness up, to get patients educated on Neffy, 'cause awareness equals going to the internet. Now, I used to say doc- Google Doctor, but now it's go to my AI bot and ask AI what does it think of Neffy. Actually, it says nice things, so we know that. And then they get educated on it, and they go to the doctor, and it's much easier for the doctors 'cause the patient's asking for it. They know all about it. They don't have to spend a lot of time, and so DTC is hugely important here, especially in this market. So those two things, I think, are very, very important for us right now. And then physician adoption, and we are seeing that dynamic occur, meaning we have about 10,000 doctors that have prescribed Neffy, but the ones... If you track the ones that started early, that have prescribed for some time, and look at their market share at that particular doctor over time, you're really seeing, like, a period of time where they were prescribing at a fairly low rate, and then all of a sudden they start to go up and that we're starting to see now, and that's really the adoption you wanna see because those early adopters that tried it out and saw everything's cool, it's working, patient thought it was fine, now they're starting to freely prescribe, and that's an important thing to see. So that's always an early- I mean, I experienced a lot of different drugs, even, you know, my Janssen days, antipsychotic agents and things, and even you get the next greatest thing, you can have the greatest efficacy data, but getting a doctor to change from what they've been doing, especially in this case for 35 years, takes a little bit of time. And so we're now starting to see that uptick as well, especially in those early adopters, and we think that's gonna be very important. So the adoption, raising awareness, and educating the patients and caregivers, and continuing to improve the access so it's easier for doctors is really what we're mainly focused on. So maybe we can backtrack to your point about just how different people are reacting to the jingle and to the ads, some favorably and some you acknowledge anno- Does it matter, like? No ... what the reaction is, as long as they're singing? No, we want them to remember. Okay. No, I mean, and in fact, it's the whole mentality of the jingle. And this, we got from various different sources, including one of our board members, Brent Saunders, so to be honest, he's been very helpful, and he takes some time, so we really appreciate that he's willing to do that. But four, five years ago, he was all about, "We got to find a celebrity." And then something shifted, and he has a lot of data. You know, Bausch + Lomb's a real DTC company, and he's CEO right now, and he said now last three years, it's been all about jingle. The celebrities have no benefit. They cost you a lot of money. Especially post-COVID, they lost a lot of credibility, so, you know, it's all about the jingle and remembering. He, like, refers to Ozempic, and he said, "People in Miami walk around the street singing the Ozempic song," and I'm like, "Well, too much heat in Miami. I'm telling you, it's very hot." I can't imagine that, but okay. But still, we did look at a number of jingles. We love the theme, "Hello, Neffy, goodbye needles," and it could be, "Hello, Neffy, goodbye anxiety," or, "Hello, Neffy, goodbye," you know, whatever. But the "Hello, Neffy, goodbye," we really love that kind of slogan. And then we looked at all the songs that could be hello goodbye and I don't know if you know Steam, but Steam is the group that actually wrote that song originally, but everybody knows it from football games, right? So it's all very popular in sports games, you know, hello, goodbye, and, you know, to say goodbye to the opponent. So we thought that was a good option. We did look at The Beatles' Hello, Goodbye, but that's a very expensive song. Okay, it's a very expensive song. I mean, $7 million a year. It was a little, little- Ooh. I love it, but little... don't love it that much. What aspect of the product profile that we hear really does resonate, that's not necessarily captured in the jingle, is the size. Yeah. To what extent, like, are you able to augment the message that consumers- Yeah ... really understand not just the needle-free but the convenience? Yeah, definitely we do. And in the commercials, we do emphasize the size, showing it, right? Showing the device. It's right in your hand. It's ready to go. We also show the carry case, which we provide for free, so it's a gift to the patients. We are working to put it in the box, so hopefully by end of first quarter, that case will come in the box with the product. And we think that's a very convenient way to carry. It fits in your pocket, it can clip to your bag, and we just wanna facilitate carriage. Now, we, as a pharmaceutical company, we have to comply with labeling, so we have to promote two. We can't tell you you can carry one, so we've gotta have the case that holds two. We know some people, you know, carry them just loose in their pockets or things, but we can't promote that. We wanna promote carry it in something that's safe, that protects it, and that's why we came up with the case idea, 'cause it's much better than any other option we can consider for the device. So- But we do try to also emphasize carriage, and certainly doctors do, 'cause that's one of the key criteria. Are you gonna carry this, and will you dose this right away when you have a reaction? Which one do you prefer? 'Cause that's what the doctors ask the patients, typically in their shared decision-making process of. They, the allergists believe very strongly, if you choose, even if you choose injection, if that's the one you really prefer, you tell them you're gonna carry it, and you have no issue injecting yourself, they're gonna say, "Okay, fine, that's it. And Josh, to the point, too, we've really pulled the imagery through all of our pieces. So everything that's in a doctor's office, everything that's online, all of our advertisements, like banner ads, you know, the marketing team refers to it as kind of the power pose, right? So we want patients to see that device, how easy, how small it is to administer, how easy it is to carry. And then just to add to what Rich was saying, too, we have a market research firm that does a monthly survey of consumers. So we look at patients, and we look at caregivers, and we've done two of those already. The baseline survey that we did around aided awareness was only about 20% for Neffy. So the one we just did about three weeks ago, it's up to about 49%. So that really shows us that the campaign is reaching kind of the audience we want to get to. Now, we know philosophically, when you do these campaigns, you know, a consumer needs to see something seven to eight times. You know, they've got to have the appointment. They've got to make an appointment. But we even ask questions in these surveys that we send out: What's your intent to have a discussion with your physician? If you went on your appointment, did you discuss Neffy with your doctor? Did you get a prescription? What did you do? And those numbers are trending in a very positive direction. The market research firm also does this for well over 200 campaigns, and they have a database where they're able to kind of index our scores to the other campaigns, and we're actually higher than what they're seeing in other campaigns. So I think the jingle 99.9% of people love it. The imagery. But it's really about saying goodbye to the hassle, right? Saying goodbye to all the challenges with a needle injector and having something that's non-invasive, it's not causing anxiety, it's easy to carry, and that really resonates with moms, with parents, and consumers. Yeah. So every week, we get the IQVIA scripts. We're very keen to see what the trajectory is and think about carrying that forward. We're now towards the end of the back-to-school bolus- Mm ... and so a natural decline in the overall market. How do you think about kind of the next dynamics as we interpret the IQVIA data and start to try to project not just in the Third Quarter but then Fourth Quarter too? Right. Well, I would encourage you more to look at month- over- month than week- to- week cause week- to- week can be a little bit dicey and ups and downs. We also had some dynamics the last couple weeks that I think people have overreacted to, but we did discontinue the GoodRx program at the end of July. We did that for a very good business reason, and that is that the GoodRx system was allowing some pharmacists to enter two coupons. Don't know why that's possible, but it was something that we couldn't stop. Meaning, if somebody came in with the GoodRx coupon, the pharmacist could enter the GoodRx coupon to get the $1.99 price for cash, but then they could still use our copay assistance coupon, which was up to $200, and they were basically, they were basically dispensing at zero. And it wasn't just zero, it was negative because we then had to pay GoodRx, we had to pay distributor, we had to pay pharmacy, so it was a big negative. So we decided to discontinue that, and for the short term, the result of that was that we went from about 20% cash- pay, which was split equally between GoodRx and BlinkRx, and we dropped to almost 10% cash- pay at BlinkRx. So we did lose a little bit of share. Now, some of those people may have gone somewhere else, some of those people may, maybe some of them have paid retail and didn't know they can get it at BlinkRx. Some may have gone to BlinkRx, but again, the number at BlinkRx did not go up dramatically. It went up a little bit, but not dramatically. And some of them may have gotten a PA, but some of them may have abandoned the prescription or just asked their doctor to switch it back to an auto injector because they didn't wanna pay $800 or $1,000, which is typically the retail price if you have no coverage, and no... You're not aware of the $199 option. So we think that the glitch we saw in the last couple weeks of a little bit of drop in market share was primarily caused by that. However, those sales were not net positive sales, okay? So they were not revenue-generating sales. So if you look at revenue, I would say that that was not, that little dip in market share was not a negative, and that it, it was a temporary situation to where we corrected for those poor sales. And any cash sale is not a great sale for us anyway, but nonetheless, you know, we think that that was probably the cause for that little glitch in the market share, and we expect that that will recover and continue to go up over time. So now, to clarify here, I thought BlinkRx prescriptions didn't go through IQVIA- They don't, but GoodRx do. GoodRx do. So GoodRx, yeah. So GoodRx, IQVIA would see, because those are retail at the pharmacy. The BlinkRx. Now, BlinkRx, prescriptions through insurance, you know, they go through IQVIA. We do show them the IQVIA. But the consignment, we call it, which is the cash- pay of BlinkRx, IQVIA doesn't see that. But that now obviously declined. But again, those GoodRx sales were not positive for us, and so we just decided to discontinue it. We were hoping that the momentum of the market share increase would counteract any loss. The other thing we didn't anticipate over this peak period, everyone was excited for the peak period. We were, analysts were, investors were, everyone was waiting for the peak season. They were thinking, "Oh, boy, it's gonna be great." We didn't realize that, you know, in the doctor's office, and this is coming back from the sales force, talking to the doctors, during those three or four weeks before school, they're dealing with double the patients. They're... They have literally double the patients or more coming through their office, and the burden on these doctors is really high during that period. Their workload is very high. And what they tell us is that any new drug they have to deal with takes them much more time than just renewing a prescription. And I think we didn't anticipate that initially, that that would be such a burden on the doctors, that we were thinking this peak season, everybody felt this was gonna be fantastic. But in reality, the doctors were so overwhelmed with dealing with the patients, that they didn't wanna take the 10 or 15 or 20 minutes it takes to discuss a new product like Neffy, and they just probably wanted to push it off. And, you know, if people were asking, they may say, "Well, I don't have time to explain this now. Let's talk about it another day." And we think that impacted a little bit what we would have expected the uptick to counteract that GoodRx stoppage. So I think, I think honestly, I think the decision to discontinue GoodRx was the right decision. Somebody could say, "Well, could you have waited a month?" Or maybe. We didn't realize that that was the case, but I think that was the reason why we saw that little downtick in market share. I mean, still, prescriptions were good, but market share was down a little bit, and I think people reacted to that. You know, that was one of the reasons why I think our stock took a little bit of a downturn at this point. How do you avoid that same dynamic next back- to- school season when it's the same problem? Yeah, I mean, next back- to- school season, I mean, what we need to do is really focus on what we... What we're doing, which I think is all the right things, moving that market share up, getting more and more people converted. You also have to remember that 50% of the scripts each year are new patients, so there is a lot of abandonment of scripts over time because especially the not necessarily the kids, 'cause the kids are forced to renew, parents are very diligent. You always care about your kids and your dog more than yourself, so that's the truth. And what happens with adults is adults tend to... They have a reaction, they get prescription, they keep it for a year or two. They didn't get another reaction. They were able to avoid the peanuts and, or whatever they're allergic to, and then they just don't renew. They just let it lapse. And then if they have another reaction a couple of years later, they make a mistake, they'll get a prescription, but they, they're very poor at renewal. But the turnover is very high in this population, so as new patients come along, we expect that they'll prefer and the doctors are comfortable, and we have access. We expect that those new patients are gonna preferentially choose Neffy over injection. And our market research shows it's a pretty high preference for Neffy over injection. So we think that will help convert the market. And then next year, what you end up with is you end up with whatever market share you have that has Neffy already, you're gonna end up with those people being a renewal, and the doctors are focused on new ones, and you just start building from there, right? 'Cause that's how you build up year after year, the market share by getting those patients on. We do see a preference for Neffy with children, so a higher proportion of our prescriptions are in children, which is good, 'cause those are the better customers for renewal, and we do already see a number of prescriptions per patient higher than injection, so we're already surpassing injection, and we expect that to grow, where people want more Neffies, and especially as access is better. And by the way, we just looked at some data recently that in people with commercial coverage who fill a prescription, right now, the average copay with Neffy is $37. The average copay with injection is $48 for a generic auto-injector. So our strategy of, for those with commercial coverage, trying to get this to a low copay is working very well, and about 80% of them or more were $25. So about 80% of that group was $25 or less. So we do have a set of patients who are very well covered, who are getting Neffy for $25, and we still have a subset that either are getting PAs and have a high deductible or are in a high-deductible plan or are getting refused and denied and are either not getting Neffy or going and getting cash. and so that's still the mix- I- that we're trying to... Yeah. And I think two other points to add on to what Rich mentioned. If you look at the category now, the class overall, the cash portion is, like, 5-6%. So as things kind of evolve with obviously getting more and more coverage, you know, no PAs, we believe that number's gonna come down. The other thing that we did is we did a lot of communication out to physicians and we're doing more to patients, that the $199 price is still available through our BlinkRx program. And the reason why we like that is because we have more control over that. It's better economics to us than the GoodRx program. So I think to your point, your question, you know, there's more and more education out there to physicians and patients of where they can get this. Although we did that before we made the change, sometimes you've got to do it more, right? It's the frequency, and it's the reach of getting to those consumers and those HCPs. So as we move past the back-to-school bolus, which is a very pediatric bolus of patients, and we've kind of normalized, we're starting to see the trends in the epinephrine market suggest that as everyone is back- to- school. Yeah ... is the target demographic changing, right, to more adults? And how do you anticipate market share evolving with this transition out of back- to- school? Yeah, I don't know that we'd say the target's changing more to adults. I think it's still the same dynamics because, again, the bolus is really renewals, and that's tough to penetrate, as I said, because the docs can renew prescriptions very quickly and easily, and sometimes they don't even need a visit to renew the prescription, right? So if it's an annual renewal, a lot of those are going through without that interaction, or with very brief interaction in the office. And so we think actually now if the docs have more time, their burden is a little bit less in dealing with the patients, we actually think they'll have more time to talk to patients about Neffy. And then people that may have wanted Neffy even during the summer, that the doc didn't have time for it, may come back. But also, again, the cycle of just rotating patients through this system and the 50% of prescriptions that are new each year, you know, if a kid has a reaction for the first time in his life, it doesn't matter if it's summer, spring, fall, June, July, you know, it doesn't matter when it happens. That's when they go into the allergist and get a prescription. And so we believe that we'll have the advantage on all those people going forward, and we'll start to build up market share based on just even that rotation, where, you know, we'll have the advantage over any other product coming in. So yeah, on the last earnings call, I think you were asked about, you know, the ability to sustain revenue beyond the bolus dynamic- Yep ... and not necessarily see a down Quarter, and you sounded very confident that you'd be able to kind of work through that- Yeah ... and not have a sequential decline. I guess the inference is that your market share has to grow- Right ... by the same offset, and that's a pretty meaningful bump in market share. Yeah, it's about 30%. Yeah. Um- The drop in overall prescriptions in Fourth Quarter- Thirty ... is about 30% less. Right. So market share actually has to probably go from, like, 3.5% to even 5%. So, like, a significant- Yeah, yeah ... uptick. Maybe even- So how- Yeah ... how do you get there? Like, what gives you the confidence that you can kind of hit those numbers, especially given where we're coming from in terms of market share and then kind of layering in these new initiatives? Yeah, well, I think we already talked about a little bit of it, that awareness shift we're seeing with the DTC campaign is pretty significant, and we're about to get our August data, so we're about to get our third set of data, and we'll be doing this monthly, but that awareness shift and the preference shifts we're seeing as people are getting more educated and seeing the commercials and going to the website and doing things, we think that's gonna drive a lot of market share going forward, and just, you know, again, it. You know, the difference between a busy doctor not having time to mention Neffy, even if it's a new patient coming in and so forth, versus, you know, a patient coming in and saying, "Hey, I saw this commercial, and I'm interested. I would like to get this, it's a very different dynamic. So we need the patients to be aware and asking, and we know that that will influence the situation pretty significantly. So we think that's a major factor in this. We don't expect Fourth Quarter for insurance coverage to change. It's gonna be pretty stagnant in the Fourth Quarter. We think we have a very high probability of Prime moving on the formulary by January one. one. They just- Just explain what Prime is. I'm sorry. Prime is a PBM of smaller Blue Cross companies, I would say. There's some Blue Cross companies are independent of Prime, but it's a grouping of Blue Cross companies that represent about 9% of commercial coverage for this indication. And then Caremark. And so Caremark, we think there's various factors that are coming together, including economics for Caremark, a lot of pressure from advocacy, 'cause advocacy is very angry that Caremark is stalling when United and Express Scripts put it on formulary six months ago. So a lot of pressure from advocacy groups. I don't know if any of you are involved in the FARE Network, but they sent out a petition on Friday to 55,000 people, a petition against Caremark. They also are going to congressmen who are not friends of the PBMs, and there's a lot of noise about why Caremark's delaying, and is it for their own financial benefit, or is it medical decision-making? I mean, what is the rationale? You know, United has a very bad reputation, but they put it on formulary quick, and their reason was medical necessity. They felt that it was medically important to get Neffy on formulary very quickly. So why is Caremark stalling? I think we got a lot of pressure from different sources, as well as we have good economic numbers now to show them that they actually can make more putting it on formulary, 'cause that's, we think, their main thought is right now they're making money processing PAs and charging the downstream payer. We think to switch, they need to see that the volume will go up high enough that they'll make more money off of us and off of our fee. And we think we're about at that position, where they'll start to see that the other PBMs are much higher market share, and that if they switched and they got to that market share, they would make more money. And that. So we're playing the economic side with them and letting FARE and other groups and the couple legislators, 'cause one's a senator, one's a congressman, that are kind of sticking their nose into this at this point, let them kind of make noise and see if Caremark just decides, "Let's not deal with this. Let's move it." But we do still have... Remember, 24% of Caremark's downstream payers have told them, "Do not restrict this," and they're coming through with no PA. So it's not like... I mean, Caremark is over 300 companies under them, and those companies have the right to make their own decision, even though Caremark's recommendation is to keep it in a new drug status. They haven't really put it anywhere, but it's just new drug prior authorization. But 24% of the scripts coming through Caremark, the companies beneath them have said, "Don't restrict this product. We want to just pay for it. How do we track- I was just gonna say, I think also, in the Fourth Quarter here, relatively soon, we're gonna have more data, too, from our Neffy Experience Program. Yeah. Oh, yeah. So the real-world data is going to be important. Just real quick, at launch, we offered the experience program for allergists that do oral food challenges and oral immunotherapy. So if a child or a patient has a reaction in the office when they're going through this procedure, you know, they would be able to use Neffy and kind of see that first-hand experience. To date, we have about 3,000 doctors that are enrolled in that, but we did a survey at the beginning, first quarter-ish, of about 300 physicians, and we have data on about 545 patients. So this is gonna be coming out in publication. It's gonna be available at a lot of the major conferences, posters, and various case reports. So I think that's also gonna, like, just put another check for Neffy around the trust and confidence in the product. How do you track the productivity of the ALK co-promote? The same way we track our team, so we started a co-promotion with ALK in the pediatric space, and we went from about 12,000 physicians to about 20,000 physicians, so they're focused on that next tier of pediatricians. So we're looking at things around the reach and frequency, call volume on their targets. We're looking at volume that they're able to generate, market share as well, just within that cohort. It's still very early. We're seeing increases, but the base was low, but I anticipate that we'll continue to see growth from that group as well, so it's really good to have, you know, about 170 reps total, with our about 100, they have about 60, and with the managers calling on about 20,000 physicians that are large writers for epinephrine. Maybe talk about, maybe some potential legislative changes to enable or encourage, businesses or restaurants to stock, epinephrine. I think California might have something in the works. Maybe can you share, just within the limited time we have, what you expect to transpire there, and whether other states are likely to follow? Yeah. Yeah, and some of this also is being pushed by advocacy groups, and they actually see Neffy as a kind of a window, because there's a lot of resistance to auto-injectors in public places, especially like restaurants. There's a lot of liability to the restaurant just having the auto-injector, and if the Good Samaritan injects themselves. But because Neffy's profile is so much safer, they can't hurt themselves with it. I think there's a lot of push from the advocacy groups to try to get restaurant safety. FARE started the FARE Certified Restaurant program, where they're doing that with the Mahomes, with Patrick and Brittany Mahomes. That is where there's not only training, the waiters are asking about allergies and checking, but also that if they're FARE certified, or FARE plus certified, I think, or Platinum certified, I think is the term they want to use, they would have to have epinephrine in the restaurant. And what they're doing is negotiating with insurance companies to try to get a discount for the restaurants to help pay for the epinephrine. But they believe that Neffy opens up that window, and now there is some legislation being kicked around in California. They just moved through the legislation to update their school legislation, their indemnification of school personnel to include Neffy as an option or non-injectable forms that are FDA approved. And there is a bill floating around that may mandate restaurants... Now, I was told by the person, 'cause I talked to the CEO of the California Restaurant Association, who's actually in favor of this, so the Restaurant Association is not objecting. They're actually in favor of it. And then, we also spoke to the person up in Sacramento that's kind of managing this, and you know, it will have some exemptions for smaller, low-revenue restaurants, but they are, you know, for good or bad, California, we do always have to do strange things, sometimes wacky things first, but they are really trying to push something like this through in Sacramento, and we'll see. I mean, it's floating around. There's several different bills for schools and for restaurants and for other things, public buildings, that are floating around right now. Right. Well, a lot of moving parts to this story. I feel like we've just kind of scratched the surface, and we're all eager to get the next week of IQVIA scripts to see how it all plays out. All right. Thanks, everyone, for tuning in. Thank you. Thanks to you guys, too. Thank you.