Okay, good afternoon, everyone. Welcome to Day Two of the Piper Sandler Healthcare Conference. This is David Amsellem from the Piper Biopharma Research team. So our next company presentation is ARS. We have Richard Lowenthal, President and CEO, and Eric Karas, Chief Commercial Officer. Thanks, gentlemen, for joining us. So, pretty exciting time for the company with the rollout and ramp of Neffy and really a new world in the epinephrine rescue space. So let's just start with your overall thoughts on early adoption of the product generally and overall receptivity. So I'll just start there, and then we can go into some more patient-level metrics.
Yeah, so I think overall, I think we're pretty happy with how things are starting to progress. I think we have about 20,000 prescribers that have prescribed Neffy now, so that's an important number because doctors often want to try to trial out new drugs, so the more and more prescribers we get, and we know that the longer they've been prescribing, the number of prescriptions they write is up and up and up, so we're starting to see that. I mean, we've also recently had some really important data that was released at the College meeting on real-world use of Neffy, which is now showing that it's working pretty much exactly the same as injection, so that's important data, and then we continue to make progress and work on access and getting insurance coverage.
One other key point here is, if you saw recently, we launched a new program called Get Neffy on Us . We can talk about that more later, but that lowers the copay for people to zero commercially insured and also makes it much easier to get Neffy through a virtual prescriber.
So you talked about the number of prescribers. Have you talked about the number of repeat prescribers and also just trajectory of volume growth?
Yeah, I mean, I think as Rich said, I mean, we have over 20,000 physicians that have prescribed the product. When you look specifically, something that we're really excited about over the last three months, that number has doubled. So a lot of the work that we've been doing in terms of building awareness, driving patients into various physician offices, we're seeing some benefits from that in terms of the number of doctors that are prescribing this product. I think in our data, too, what you see often is doctor tries it, gets some experience, and then you see continued use of the product or more prescribing. And I also think we'll talk a little bit more about this.
The data from our experience program has been really strong in terms of physicians that have been part of that program, of them using even more product. We're probably seeing about a two to threefold higher market share with those doctors. And now that we have that data where we can go out our sales team and through marketing, we can make sure that doctors are aware of all that data. We're very encouraged and excited about that.
What kind of hurdles, if any, to access are you seeing out there? And I know you've talked broadly to copay assistance, but what has generally been, if anything, the biggest sort of payer challenges?
I'll start and then be very careful of what I say here.
But we actually have had really good uptake and payer access with a large number of the payers, some that have bad reputations, maybe like UnitedHealth Group, but they actually cover Neffy very, very quickly and do a very good job of covering Neffy because of medical necessity. So they basically deemed it as a very important product in their minds. The outliers tend to be CVS in general is a very difficult payer and continues to be difficult. We believe we are making progress with them, but they continually try to figure out how much they can make. So that's their interest more than medical need. So I'll be nice about it. And then some of the Blue Cross players who tend to try to delay coverage with any drug.
They're always notorious for that, probably to manage their internal cost and plan in the price into their premiums, but they tend to push off covering. Now, some have covered already very well, like in Massachusetts. They've covered quite some time now. Some are still stalling, and there's a few Blue Cross that are blocking Neffy. Still working on those. But overall, making progress, and then one other point on this with Medicaid, we have eight states that have Neffy at preferred status already with Medicaid, so one year into it. We're working on strategies to try to get the other states to cover, but we are potentially looking at different options for that as well to get a little better coverage with Medicaid.
Is the hurdle mainly just preferential access to injectable forms of epinephrine?
Yeah, I mean, I think for Medicaid, you mean, or for other?
Just in general, yeah. Commercial and Medicaid.
No, I think where we have good coverage, I think the market share is markedly higher where we have unrestricted coverage. So we see very good coverage or very good uptake in those areas. So it's really where the PAs are required. It's still a little bit of a doctor burden issue. And then obviously with Medicaid, where PAs are required, with most Medicaid states still. Yeah. And I'll just add too. I mean, when you look at kind of the commercial marketplace, having two of the big three PBMs, we have Express Scripts and Optum. In my experience of every product that I've launched and been part of, CVS Caremark is always the most difficult. When we sat down and we had conversations with Express Scripts and Optum, their clinical folks, they really understood the value proposition of Neffy.
And clearly, needles, safety issues with auto-injectors, hesitation, and what we offer and something that's easy to carry, easy to use, was very attractive to them. So this is very typical in what I've seen kind of in your first year to two years of launch, but we're confident in time that we will get them. And as Rich said, we are making really good progress at the state level with various Medicaid plans too.
So let's talk more about Get Neffy, and I just want to understand the details of the program and how Get Neffy helps with patient activation, with overall access. So it's not just a website, right? So just help us understand what it is and what it does and how it helps ultimately activate patients and get drug in their hands.
Yeah, so two maybe pillars to it. And so one is, obviously, we lowered our copay to zero. So we're trying to make the barrier for a patient caregiver to get Neffy as low as possible. And even people who may have just got a prescription for an auto-injector, if you say even the cost is $25, they may be reluctant. They're going to wait. But if you say it's free, it's zero, then there's no barrier for them to go get another. They're like, "Okay, well, then I can get that too, and I can both, right? And I can get Neffy as well. And then once I'm comfortable with Neffy, I won't renew the prescription for the auto-injector." So that's fine. So that's one piece of it is we're trying to make it as, let's say, no-cost barriers, at least to the patients and caregivers.
The second is the virtual aspect of getting a prescription, and this is from two aspects. From a caregiver-patient perspective, I want to go get Neffy. I saw a commercial. I saw an advocacy website, whatever, and I said, "Oh, that I really like. I want to go get that." It's going to take me three to six months to get an appointment with a doctor. I got to spend three, maybe four hours going to the doctor, sitting in the doctor's office, lose half a day of work. That in itself is a barrier to patients and caregivers that they have to wait. They got to go there, so we now are offering a free virtual prescriber service. Takes maybe 10 minutes, maybe less. It can be asynchronous in a lot of states, meaning just by email. You don't even have to talk to the doctor.
And you can get Neffy prescribed. You can get not just one pack, but two packs of Neffy for zero, for no cost. And then it could either be a prescription sent to your local pharmacy. You go pick it up, or it can be mailed to you. So there's an option. So we're just trying to make it as easy and transparent for a patient, a caregiver to get it. Now, from a doctor's side, what we learned over the summer, especially, is that the burden on doctors to prescribe is actually much greater than anybody would anticipate, especially in this space, in an allergy community where these doctors are under a lot of pressure to see as many patients as they can. Any new medication takes time for them to explain to the patient, show them how to use the device, everything else.
Even if it's not a device, you got to still explain how to take the medication, so it takes time, and then there's always the risk of a PA, which takes even more time. The message to the doctors, which has really resonated well, we're very pleased that the doctors are thrilled about this, is now you have an option. You can still deal with it yourself, and we're not interfering with your patient relationship, but you have an option to, rather than take that time, you can send the patient immediately to getNeffy.com, and we'll take care of the rest. We'll prescribe, we'll train them, we'll provide training, and we'll deal with a PA if it's necessary. That's one piece.
You can also write the script, send them down to the local pharmacy, and if it gets bounced back as a PA is needed, then send them to getNeffy.com, and we'll take care of it, and you don't have to deal with it. So we're trying to make that easier for the doctors and more transparent. So it's both sides. It's the patient caregiver and the physician side that we're trying to resolve those issues.
Where does DTC fit in all of what you're trying to do? I mean, obviously, raising awareness is a big part of driving business here. So help us understand the role of DTC.
Yeah, I think it is in large part raising awareness, right? So awareness when we started of Neffy was relatively low, under 20%. It's now over 50%. So we are making good traction with making sure patients' caregivers are aware of Neffy. Equally, doctors, I think allergists are very much aware of Neffy, so that was not necessarily an issue. But you got to remember, there's a lot of doctors out there that prescribe epinephrine, even if they're just small numbers of scripts. And for our salesforce, we're hitting now with our combined salesforces about 55% of the market. And then when you look at that 45% underneath, it's so diverse. Doctors writing five, 10 prescriptions a year. It's not cost-effective to send the sales rep, but direct-to-consumer or direct-to-healthcare provider type advertising, and they watch commercials and TV shows also so that you get to the doctors as well.
That's really beneficial to raise awareness across those lower decile doctors that we would not visit. A lot of them are PCPs, but they're not prescribing much, but at least they'd be aware. So I think that's also very helpful.
And I would just add too, I mean, in a lot of our promotion digital and what you're seeing in our TV commercials, and we're going to be continuing to amp this up, is really identifying for the patient the challenge, right? We know that our product is needle-free. We know that obviously an auto-injector is a needle, but there's so much more to that, right? If you talk to parents about the trauma that they go through when they have to inject their child, it's real, right? So think about a patient that, let's say, was prescribed six months ago. How can we get them to switch now? And kind of think of it as almost like upgrade on us, right? We're taking cost off the table. There's no cost for the virtual visit. They go online.
They can go through this process very short, five, 10 minutes at the most. A lot of times it's even less. But then get that patient now, convert that patient. So again, when those refills come in the future, we've got that base of patients. But then you also look at the other audiences too, patients that were prescribed historically. Some of them have filled the prescription for an auto-injector, but they haven't refilled, or a lot of those patients haven't even just filled. So this is a great way to kind of message to them as well. If they don't want to go to the doctor, they can go online and kind of get this right away.
I think we all know there's a pretty strong movement over the last couple of years of more and more consumers and patients are very comfortable going online to get their medicine.
You've talked previously about Neffy actually expanding the overall epinephrine market space. So can you provide some metrics on that?
Yeah, yeah. So we can start to see that happening. So in our current data, about 80% of the patients getting Neffy, 80% of the prescriptions are coming from switchers, but about 20% are coming from expansion market. Roughly 13% are people that have been prescribed an auto-injector and didn't fill the prescription. So there's 3.2 million people in the first bucket of people that have an auto-injector. They fill the prescription, and that's the switcher group. There's 3.3 million that have received the prescription, meaning they were told by a doctor, "You really should have epinephrine," but they didn't fill the prescription. And a lot of them because they didn't like the device, they didn't like the injection. So we are seeing about 13% of our scripts already coming from that segment.
And then about 7% is coming from a group of 13.5 million people that have never received a prescription. And honestly, these people are not visiting the right doctors. They're not. 2% of them are with allergists, so 98% of them are visiting other doctors. And a large percentage were diagnosed in the emergency room and left the emergency room and never saw a doctor. But we are starting to see some of those people come in. And when you talk about DTC, that's a segment where I could say that's very important to that segment because they are not visiting the right types of doctors. They're not visiting allergists.
So they need to see not only our DTC campaign, but our public service announcement campaign that we're supporting, we're sponsoring with FARE because both coming together, you try to get to those people to say, "You really should get something." And now it's virtual. You don't have to go to the doctor. If they're reluctant to go see a doctor, now we've got the virtual option, and you can get it if you're insured for zero. So we think that that will start to build over time. But we are seeing a good uptake in those markets.
That's helpful. Just looking broadly, I mean, just at the population of patients who are at high risk of an anaphylactic reaction or severe allergic reaction, what portion are these patients not even seeing a doctor?
Yeah, and that's what I'm saying is I think if we look at the world. So if you look at the spectrum, there's around 40 million. It ranges a little bit depending on what data you're looking at, but it could be 40-45 million people in the United States that have food allergies or venom allergies, right? About 20 million we put in the bucket of people that have more severe disease that probably should have epinephrine. Okay? The other ones have less severe disease. And then basically, we're only seeing 3.2, about 15% of the population that probably should have epinephrine that actually fills the prescription. There's a lot of room for expansion here.
That doesn't count other uses for institutional buyers, which there's a big barrier for institutional buyers to buy auto-injectors because of the liability, the risk of using an auto-injector. With Neffy, there's no risk to it. So there's no risk to the actual, let's say, Good Samaritan in a restaurant trying to help somebody having a reaction. There's no risk to the person administering or to injuring the person that they're helping. So it lowers their liability for an airline or a restaurant or other public uses. And then again, like we saw with Narcan, police, fire, they're not medically trained. They can't use an injection. And even on an airplane, by the way, you always hear the announcement as they're a doctor on board the plane. If they have injection, the flight attendants can't give it.
They have to try to find somebody on board the plane that's medically trained, and of course, my wife is a doctor. She goes under the chair. She does not want to be involved, right? So there's a lot of doctors that won't raise their hand on a plane. And so this takes that all away because you don't have to be medically trained to use the nasal spray products. So you can administer it and take that issue off the table.
So can you talk about real-world outcomes data associated with Neffy? In other words, you have a good read on patients with an anaphylactic reaction who have actually used the commercial product and what the outcomes were relative to Neffy?
Yeah. So right now, we have two great pieces of data. We're working on a third piece that's going to be kind of the pinnacle of any data that there is in the world. But what we know from injection, from meta-analyses on use of injection, is that about 90% of people get complete response from a single dose of epinephrine, and about 10% of people need a second dose. And it doesn't matter if it's IM, needle, and syringe or EpiPen. It's pretty much across the board. It doesn't matter how you get the epinephrine in the body. It seems to be pretty consistent that you get that effect. So we have two things.
One, we did a phase III study, small phase III study in Japan, which was required by the Japanese authorities because they were fine with PK/PD, but they just couldn't get over not treating a patient. So they wanted to see us treat actual patients having anaphylaxis in Japan. We did that. And we saw, I mean, it was a small number, but 100% of the kids respond to a single dose. Okay? In our Neffy Experience Program , where we're giving Neffy to clinics, the idea of this originally was to give the doctors firsthand experience so they could see how well it works. So if you're a clinic that's doing oral food challenge immunotherapy, we give you six boxes of Neffy or six doses, and you can try it out in the clinic. We've been able to replenish some that are using a lot, and they've used it.
They're really happy with it, so we've given them more, but from that program, we were able to collect data, so recently at the college, we published, I think it was 685, something like that, 680 patient data. And we're seeing literally about 90% are responding to a single dose, and 10% needed a second dose, but that's exactly the same setting as the meta-analysis that was done because the data is almost equivalent because that data was also collected from oral food challenge clinics, so we're seeing basically that comparison to say that Neffy in the real world, these are real patients, all comers. Whoever's going to get oral food challenge immunotherapy is eligible, and we're seeing that the effect of Neffy is equal to injection, and I think that's really helpful now that that's there and published in the journal. I think it's already published.
Yeah, it's already in Annals, so it's already published. So now we can use that to go to doctors who are not part of Neffy experience to say, "Hey, look, here's the real-world data showing it's working pretty much exactly as would be expected.
And just to build on that too, at the College meeting a few weeks ago, we had a small advisory board with 12 allergists, and they all believe in the product, but when they see this data, it just gives them even more conviction and trust and confidence in the product, and a lot of times, the scenario is mom comes in and says, "Oh, I've heard about this. Do you have any experience? Does it work?" Right? Now the doctor can reference 680 patients, so it's really powerful to have this. Our sales team has been trained on this. We're integrating it into all of our kind of promotional education to physicians, so we're excited to have data like this.
Yeah. So what's your view on more entrance in the space? I mean, we talked about how underpenetrated it is. So do you envision continued expansion of the market with more needle-free options entering?
Yeah, we would. We actually would. I mean, we're not that concerned about it from that perspective. I mean, there's still a question of whether any of the competitors we see right now, they will get approved because none of them are kind of meeting the same criteria yet. But assuming one of them gets approved, we think that the additional voices in the market are just going to help to expand it and pull more people in. So they could take a percentage of the market, but at the same time, if the market grows overall, it's not going to hurt us. So we think there's a balance between those two.
Yeah. What about ex-US opportunities for Neffy? I'm particularly interested in what kind of pricing you can get in ex-US market, mainly Europe.
I tell you because we are looking at that very carefully in terms of if everybody has seen yet, but the new CMS program for Medicaid is the generous program, they call it. And it's now looking at ex-US pricing as part of the most favored nation type approach. We've been getting exceptionally good prices overseas, especially when you go through the most favored nation calculations. So in Germany and UK, we've launched and have prices. It's more than 2x of the EpiPen price in those countries. Japan also. And in fact, the most favored nation conversion from the Japanese price, which is quite remarkable, it's JPY 40,000 per two pack. So the conversion that you do, their net is higher than the US net in Japan. So our price in Japan is actually quite good relative to any place in the world.
Japan should launch, I think, by the end of this year, beginning of January. They're going to launch in Japan. We got their published price. We also will expect approval by the end of the year in Canada and have a price in Canada, which is also very, very good. We're seeing prices across the board in all the countries that either are a partner in Japan or AOK in Europe and Canada have gotten where it's more than 2x of the EpiPen price. We think that's really showing the value of Neffy, that even the European countries are acknowledging the value of the product and giving very good pricing. In Germany, their market share growth has been quite remarkable because they did get central approval for pricing. They didn't go commercial first. They went right to the central authority.
So it's a one-payer system, right? So there's no PAs. There's no barriers. It's a one-payer system, and everybody can get it.
Got it. I want to spend, we have about 30 seconds left, but I want to talk about CSU and just frame the unmet need here and how you're thinking about the opportunity for Neffy.
Yeah. We're now in our phase IIb study. The difference between our phase I was in the clinic, and it was with refractory patients. We saw the remarkable effect of epinephrine as expected. Not so unique because if you remember, doctors forget about things. 40 years ago, you came in with CSU, and you were so irritated you couldn't tolerate it, the doctor would give you a shot of epinephrine. Now, doctors forgot about that. We have some of our older KOLs remember. What we're trying to do is basically treat an unmet medical need in patients with CSU. You could be on antihistamines. You could be on Xolair. You could be on, I'm forgetting the name now again. Sorry. The new one.
Repcit.
it, yeah. And you could be on any of those drugs. These people still have flares. They have acute exacerbations. A lot of times, they go to an ER. So with the Xolair studies, three to five times a year, people were going to the ER in their studies because of these exacerbations. But it is a very annoying, very upsetting situation. Epinephrine is exceptionally effective at treating it. But just on an acute, we are not talking about every day. We are not talking about even every week. We are talking about if they have a flare once a month, once every two months, they can very quickly resolve the flare, stop the symptoms. We had statistically significant reduction in itch in five minutes, which is the most annoying part of it. And we think it is a big market. We think it could be a big expansion.
Our phase IIb, by the way, is looking at an even lower dose than we tried before, so the product will be different than Neffy. The dose will be much lower than Neffy, so we're trying to resolve what the dose will be, and we're looking at at-home use, so this is real-world at-home use. So we're testing our tools for collecting the data. It's the same score that you would use for Xolair or other products. It's a UAS score, but it's UAS over minutes, not over days, so we're not talking about UAS 7. We're talking about UAS over five minutes, 10 minutes, 15 minutes, and so we're really going to see a very rapid effect, and we're running the phase IIb now. We expect by the end of next year to be able to start our phase III study.
I think we'll be able to get approval with the one phase III study.
Okay, well, I know we're out of time, so thanks, Rich. Thanks, Eric. Thanks, everyone in the audience.
Thank you.