Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation
13 Nov 2025
“What you have to do in a market like that, where it’s highly genericized, is first you have to have a clinical differentiation,” says Richard Lowenthal, CEO of ARS Pharmaceuticals. “You have to have a benefit to the community, benefit to the patient population. Neffy achieves that very effectively by providing an option that’s very simple — it’s easy to carry, it’s very easy to use.” In this episode of Vanguards of Health Care, Richard sits down with Bloomberg Intelligence analyst Ann-Hunter van Kirk for an in-depth interview about how the company has navigated the commercial launch of its needle-free epinephrine nasal spray, neffy, in a highly competitive genericized market.See omnystudio.com/listener for privacy information.
Chapter 1: What is ARS Pharma and its mission?
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Welcome to another episode of Bloomberg Intelligence's Vanguards of Healthcare podcast, where we speak with leaders at the forefront of change in the healthcare sector.
I'm Anne Hunter-Van Kirk, Senior Biopharmaceuticals Analyst at Bloomberg Intelligence, the in-house equity research division of Bloomberg, and I'm very pleased to welcome today's guest, Richard Lowenthal, CEO of ARS Pharmaceuticals. ARS Pharma is a biopharmaceutical company dedicated to protecting patients from allergic reactions that could lead to anaphylaxis.
The company is commercializing Nephi, which was approved August of last year, an epinephrine nasal spray for emergency treatment, including anaphylaxis. Rich, can we first start out with your background and what led you to co-found ARS?
Yes, certainly. Thank you. I've been in the industry about little over 30 years, started my career at the food and drug administration after graduate school. and then moved into industry after about five years at the FDA. And during my time in industry, I worked on a number of different programs, including some that were nasal spray products and including some experience with epinephrine.
More recently, I was one of the people that helped develop Narcan nasal spray and, in fact, was the lead representative to the Food and Drug Administration and got Narcan approved. Also, some other emergency use nasal sprays, like where my clinical research organization Pacific link did all of the clinical work and regulatory work for that program.
And we got that approved for a company called, which is here in San Diego as well. And then we worked on a number of others, including Opvi, which is the second opioid antagonist, meaning for opioid overdose approved by the FDA that's a nasal spray. And then some others like Tesamra and other nasal products that we worked on.
So based on that experience and working with the company that owned this absorption enhancing technology we're using, Intravail, The company is Aegis. We made an agreement with Aegis to license the technology for an attempt to see if it would work with epinephrine. And we did that basically as a small company. We started ARS based on that. And initially we are self-funded.
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Chapter 2: How does NEFI differentiate itself in a competitive market?
So there's not typically an age differentiation in this disease. Epinephrine is dosed by weight. So for 30 kilograms and above, they would take a two milligram dose. Earlier this year, we got the one milligram intranasal epinephrine dose approved, which is for children 15 to less than 30 kilograms.
The children in that population, the one milligram dose that got approved earlier this year, it's roughly 24% of the market, of the prescription market today. And we're seeing that market share in that part of the market growing quite well.
um and then and then of course we are also working on a dose we call it our baby dose but it's a dose for uh children that are 7.5 kilograms to 15 kilograms so that's approximately six months of age to a small four-year-old or a you know three-year-old um at the upper end um and we're we're also working on that and hope to have that approved um sometime late next year
Fantastic. And so maybe we can switch over to think about, you know, PBM reform. And this is an area that a lot of companies struggle with. You know, what was your experience dealing with PBMs and do you have any overarching thoughts on the process?
Yes, well, we're still dealing with, of course, we're about a year into the launch and we have, we have relatively good coverage. We have about ninety three percent of insurers that will cover. 58% are approving NEFI prescriptions without any prior authorization or other paperwork. So it's simply send a prescription to the pharmacy and it's automatically filled.
About 35% of the insurers out there still require prior authorization. The ones that are still requiring prior authorization or are not covering NEFI, so only 7% are not covering NEFI right now, They're mainly in the CVS Caremark Aetna category and Anthem category. or some of the Blue Crosses. And some of the Blue Crosses are covering NEFI. Some are delaying. Some are still assessing it.
And a few of them have decided not to cover NEFI, although we're working to overturn that decision, of course. With regards to PBMs, we've had a mixed experience so far where Express Scripts saw the medical value of NEFI very, very quickly. And they covered it based off of medical value. Now, I'll go into the structure of these agreements with the PBMs when you're talking about PBM reform.
But certainly Express Scripts saw the medical value, and so did UnitedHealthcare. So UnitedHealthcare Optum, so Optum, Express Scripts, and Caremark are the three big PBMs. United Healthcare, United Health Group, United Healthcare Insurance and Optum covered NEFI very, very quickly also within about six months of launch.
And they also did it based off of medical value that they saw there was a medical need and they basically moved to contract very, very quickly and cover NEFI very quickly. Caremark has been delaying. We've been working through the issues with care mark and we're still hopeful that we will get care mark to cover very, very quickly without prior authorization. They do approve.
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Chapter 3: What challenges did ARS face during the commercial launch of NEFI?
And that's why what you see as the wholesale price and we can talk about this. A little bit, I think you have other questions you're going to ask about this, but what you see as the wholesale price as a manufacturer, the developer of this product and put in all the research and development money and our investors and also as the manufacturer, we get roughly 50% of that price.
So, when we take into account the PBM costs, the rebates back to payers, the distribution costs and the retail pharmacy costs and our copay assistance program, we retain about 50% of the actual published price of the product.
And that's a big delta. Yeah, so let's dig in more. Tell us about how you think about pricing, also maybe kind of the future of pricing and inflation concerns, and also maybe in the backdrop of a market with tariffs. How does all of that play into your pricing?
Yeah, so in our pricing strategy, we try to work very hard to protect the consumer and the patient. So the patient caregiver, I say, is consumer, right? Because in large number, it's the caregiver making the decision to buy or which epinephrine product they want to buy. So we... Mainly focused on them, so that there's no price barrier to switch to.
Of course, if they're insurers is insurance is not covering yet or or they're denied on a prior authorization. Of course, there's some price barrier in that regard, but I'll talk about that in a minute. But we focused in that regard to keep that copay as low as possible. We started off with a 25 dollar copay, but we've now lowered it to 0.
So that copay should be zero for any commercially insured person who gets coverage and doesn't have very high deductibles. And the reason we... Focused on that is that that that is the decision maker and getting the product. We think this is a very consumer oriented type of product. It's. The allergist practice shared decision making.
So, if if a patient has a strong preference for 1 epinephrine product over another. The allergist will generally prescribe that because again, their main focus is that you're willing to carry it and use it. So, if you tell them, I prefer that 1, it's smaller, I can carry it. I'm not afraid of the needle. I'm going to use it very quickly when I have a reaction.
That's all the allergist needs to hear to be convinced that that's the right product for you. So with that said, I mean, our wholesale price had to account for that copay assistance to buy down the copay. Typically, you know, if it's a preferred product, the copay is going to be in the 25 to 40 range. And if it's a non-preferred, it's probably in the 80 to 90 range. on average.
And so we buy that down to zero and we price that into the wholesale price of the product. So that and as I've just mentioned, the PBM costs, the rebates, the distributor costs is how we basically price the products so that we could retain enough of the net to cover our costs and repay our investors and cost of development. We are lucky at ARS because we are not very affected by tariffs.
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Chapter 4: How does NEFI's administration method impact patient outcomes?
So we believe having a virtual prescriber option is also important for a lot of patients who want to switch, and we're just starting that program now.
Fantastic. And the direct-to-consumer market is, of course, receiving a lot of attention now with an increase in the untitled FDA letters. From your perspective, and the US is, of course, one of the only places where direct-to-consumer is allowed. From your perspective, how does that kind of change marketing in the rest of the world for you?
Well, for the rest of the world, it doesn't really change the approach. Obviously, our partner, ALK, who's launched in Germany and UK markets, mainly the doctors, although there are websites and things consumers can get to. So we do see a lot of consumer activity, even from Europe, asking questions about NEFI and your NEFI. In Europe, it's called your NEFI. We had a little issue with
one country and of course in europe all countries have to agree so we had issue with one country with the name nefi but otherwise we we decided to use uh your nephew e-u-r nephew um so we keep the nephew name and in japan it's approved now but hasn't launched yet it should launch in a few months and it's it is nefi in japan um so uh just to get back to the to the to the u.s side um
We don't believe there's much impact on us currently with the DTC. I don't know how to describe it. It's not a concern, but the effort of the agency on direct-to-consumer. NEFI is actually kind of a poster child of a drug you want to advertise directly to consumers. There's an underutilization of epinephrine. Only about 15% of the patients that really should have epinephrine, have it.
And on top of that, very, very few of them carry it and use it. So there's a lot of lack of education and a lack of understanding in this market especially. And by advertising directly to the consumers and getting them to even go to a website and check out research, Well, what options do I have?
I didn't know there was an option other than injection, and I didn't want to get an injection because I won't inject myself. Just people like that who we know 50% of the auto-injector prescriptions are refused, are not filled because people don't want them. So it's not really a cost issue as much as people just don't want to get an injection. The doctors prescribe it anyway for liability reasons.
but the people refuse to fill them. So there's a huge benefit actually of informing them, educating them about different options and about the need for epinephrine in general. And it's also why we're in partnership with Food Allergy Research and Education, also called FAIR. They're the largest advocacy group in the world for food allergy and venom allergies. And we're in a partnership with them.
We provide a sponsorship to them. They're running public service announcements and we're, we're supporting that because it's not just about nephew. It's about the market in general. And the fact that there's such a huge percentage of this market that is not using epinephrine, not well-educated. So in that context, DTC is actually important to help inform patients.
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Chapter 5: What strategies does ARS use for pricing and copay assistance?
Fantastic. Richard, thank you so much for joining us today on Bloomberg Intelligence's Vanguards of Healthcare podcast. I'm Anne Hunter-Van Kirk, Senior Biopharmaceuticals Analyst here, and we are so pleased to have spoken with Richard Lowenthal, CEO of ARS Pharmaceuticals. Thanks again.
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