ARS Pharmaceuticals, Inc. Q2 FY2025 Earnings Call

Good morning and welcome to the ARS Pharmaceuticals Conference Call. Please be advised today's conference is being recorded. I'll now turn the call over to Justin Chakma, the Chief Business Officer. Please go ahead.

Good morning, and thank you for joining our second quarter 2025 earnings conference call. This morning, we issued a press release detailing our financial results and commercial highlights, which is available in the Investors & Media section of our website at ars-pharma.com. With me on the call are Richard Lowenthal, our Co-Founder, President and CEO, who will review recent corporate updates and achievements. Eric Karas, our Chief Commercial Officer, who will cover our commercial activities and progress and Kathy Scott, our CFO, who will provide a summary of our financial results and cash position. Before we begin, please note that today's remarks may contain forward-looking statements. Actual results may differ materially. Please refer to our earnings release and SEC filings for further risk disclosures. With that, I'll turn the call over to Rich.

Thank you, Justin. Good morning, everybody, and thank you for joining us to discuss our commercial momentum with neffy in the second quarter of this year and early weeks of the third quarter. We have long believed that a needle-free portable and reliable epinephrine treatment option could transform how patients and providers treat severe allergies. The commercial data we will share today confirm that this vision is becoming a reality. Neffy is gaining traction across prescribers, payers and patients, which we will talk about during this presentation. Our momentum is reflected in the continued quarter-over-quarter growth in the U.S. net products revenue for neffy. In Q2, we achieved $12.8 million in net product revenue in part driven by the availability of our 1-milligram pediatric dose starting in May and steady traction we have made with payers. With 93% commercial coverage today, neffy is accessible to the vast majority of patients with commercial insurance. Perhaps more importantly, this momentum has translated into strong and accelerating growth in neffy prescriptions, a clear indicator of demand and commercial execution. From the end of the first quarter to the end of the second quarter of 2025, we saw an increase of 180% in weekly two-pack unit volume, which was in line with our internal expectations and consistent with analyst forecasts. This growth is particularly encouraging as it comes before we have realized the full effects of three key important drivers. First, the rollout of our national DTC campaign, which started with targeted advertising in early June and was followed by an expansion to linear TV in July. Second, our U.S. pediatric co-promotion with ALK, which was fully deployed in late June. And third, the peak prescribing season of late summer and early fall as parents and children head back to school. As such, we expect to see even greater growth in neffy prescriptions in the third and fourth quarters of this year. Beyond our U.S. commercialization, our partners are executing well to establish neffy as a global brand. In June, ALK successfully launched EURneffy in Germany, the first country outside the United States to have commercial access to intranasal epinephrine. In July, EURneffy was approved in the United Kingdom, which is the largest market outside the U.S. for epinephrine auto-injector sales. Looking ahead, we expect additional regulatory decisions on neffy in Canada, Australia and Japan by the end of 2025 and in China by the first half of 2026, followed by commercial rollout starting in the first half of next year. We also expect approval of the 1-milligram pediatric dose by the European Medical Agency in the first half of 2026, which would trigger another $5 million milestone payment from ALK. Beyond our first approved indication, we're expanding the reach of our intranasal epinephrine technology with the initiation of a randomized controlled Phase IIb clinical trial in chronic spontaneous urticaria, a life-altering condition that affects millions of people. This study is underway with sites in the U.S. and Europe, and we anticipate top line data in the first half of 2026. Let me now turn the call over to Eric to review our U.S. commercial performance in more detail.

Thank you, Rich. Starting first with physician engagement and demand, our 118 person sales organization at ARS has now reached approximately 15,000 health care providers. More than 9,700 of them have a dispensed prescription for neffy, with over 70% coming from the highest three deciles of prescribers. These figures reinforce the strength of our physician targeting and engagement strategy. The neffy Experience program, which now includes the 1-milligram dose, has successfully enrolled over 2,800 allergists and approximately 20,000 doses of both the 1-milligram and 2-milligram neffy have been distributed for use in offices during oral food challenges. With hundreds of uses already recorded, the real-world exposure is helping to build confidence in the effectiveness and safety of neffy. We anticipate sharing more outcomes data from this program later in the year. Over 3,200 schools have joined our neffyinSchools program, establishing neffy as a preferred epinephrine treatment in educational settings. With the 1-milligram pediatric dose availability, participating schools can now carry both 1-milligram and 2-milligram doses for emergency use. Since the end of the first quarter, 14 states have updated their legislation to allow designated school employees to administer our needle-free epinephrine during emergencies. This change reflects the strong demand for neffy. The advocacy for neffy was also clearly expressed at the National Association of School Nurses Conference that ARS attended in June. On the payer front, we have reached a critical inflection point with 93% commercial coverage, including in scenarios where prior authorization is submitted. Approximately 57% of commercial payers do not require prior authorizations for patients to fill neffy. For those payers that do require a prior authorization, health care professionals can now manage the process more easily. The prior authorization approval rates for neffy with payers under the major PBMs closely aligned with the access levels in the overall commercial epinephrine market. For example, payers under Zinc Health Services, the group purchasing organization for CVS Caremark, account for approximately 30% of neffy dispenses, in line with the overall epinephrine market. This is despite more than three-quarters of CVS Caremark members still requiring prior authorizations. It's encouraging to note that these prior authorizations are being approved more than 80% of the time. For patients with commercial insurance, our co-pay assistance program ensures that most individuals only pay $25, which is significantly less than the average $40 for a generic injector. Additionally, co-pay support is now automatically applied at the point of sale in 95% of pharmacies, including all of the major retail pharmacies and grocery store chains, such as CVS, Walgreens, Walmart, Rite Aid, Costco, Kroger and Publix. With increasing fill rates, this program ensures that patients can access neffy when they need it the most. Together, these changes represent a meaningful shift for our early launch phase. Broader coverage and streamlined prescribing are enabling a more confident and seamless experience for healthcare professionals. And as neffy volume increases in the coming months, we expect additional PBMs to remove prior authorization requirements and adopt contracts that recognize the value of neffy at terms that are consistent with our 50% long-term gross to net retention guidance. This will further eliminate potential barriers to access for patients. Turning to consumer engagement, our direct-to-consumer campaign, "Hello neffy, Goodbye Needles" is gaining traction. The campaign launched in phases: connected TV and streaming platforms began in late May and early June followed by broadcast and linear television in July. We've since expanded both the reach and frequency on linear TV to further increase branded awareness and encourage patients to ask for neffy by name. Since the campaign began in late Q2, aided awareness has increased significantly. In the second half of July, Cantor, a market research firm, conducted patient and caregiver surveys. The results show that nearly 50% of respondents recognized and recalled our DTC advertisement for neffy, which is higher than the Cantor norms across approximately 150 other DTC campaigns. The branding for the neffy ad was notably strong, with half of the responses stating that they could not help but remember that it was for neffy, which also exceeded Cantor norms. As awareness grows, we expect a continued increase in demand for neffy over time. Historically, DTC campaigns for pharmaceuticals start to show an impact about 12 to 16 weeks after they begin. Additionally, we know that the average consumer needs to see an ad about seven to eight times before they take action. We are confident in the feedback we've received and the expected broader impact of our DTC campaign. Lastly, we are pleased with the positive growth trajectory in the volume of neffy prescriptions. Feedback from our sales organization indicates increased adoption across all patient segments. This includes patients switching from auto-injectors, those with a lapsed prescription returning to therapy, and new patients being prescribed epinephrine for the first time. This broad-based adoption highlights the appeal of neffy as a preferred treatment in the epinephrine market. The combination of our field execution, increased consumer awareness and demand, and a smoother prescribing experience for healthcare professionals has established a strong foundation for continued commercial growth. I'm proud of what the team has accomplished so far and look forward to sharing more about our progress in the second half of the year. I'll now pass the call over to Kathy to walk through our financials.

Thank you, Eric. We continue to maintain a strong cash position while investing significantly in the commercial growth of neffy. Starting with our revenue for the second quarter of 2025, we recorded total revenue of $15.7 million. As we go forward, it's important that we look at revenue in terms of product revenue from our core U.S. commercial efforts and then collaboration and supply revenue separately. That distinction is key as U.S. net product revenue reflects underlying demand and loss penetration with neffy. The milestone and supply revenues, while important for our overall financial performance, represent one-time or partnership-related income streams. Our U.S. net product revenue for neffy in Q2 was $12.8 million, reflecting a 64% increase compared to net product revenue in the first quarter of the year. We expect to see continued growth in product revenue as we start to recognize the impact of our DTC campaign as well as the prescription growth and improved payer access environment that Eric described. In terms of collaboration revenue, a $5 million milestone payment from ALK was triggered related to the launch of EURneffy in Germany in June, and we generated an additional $0.3 million in supply revenue from our partners. Of the $5 million milestone, we recognized $2.6 million of revenue, and the remaining $2.4 million was recorded through the financing liability on the company's balance sheet in accordance with the GAAP accounting treatment of our original licensing agreement with ALK. With regard to the EURneffy 1-milligram dose in the EU, we anticipate EMA approval in the first half of 2026, which would trigger additional $5 million milestone payments from ALK. Similarly, approximately half of that $5 million would be recognized as GAAP revenue in the first quarter of 2026, and the other half would be added to the financing liability on the balance sheet. Turning to our operating expenses. R&D expenses for the second quarter were $4 million, primarily related to the initiation of our Phase IIb urticaria trial and continued clinical and development expenses for neffy. SG&A expenses were $54.3 million, reflecting our investment in a strong national DTC campaign and continued sales and marketing efforts for neffy. We remain committed to making substantial investments in the launch of neffy to ensure both short- and long-term patient and physician awareness and market share capture. As a reminder, for modeling purposes, the bulk of our DTC campaign investment of approximately $50 million will be recognized in our SG&A expenses in the second and third quarters of this year. Lastly, cost of goods sold increased from the first quarter due to higher product sales and also establishing a one-time inventory reserve for older inventory. This is not expected to recur, and COGS for neffy remains highly favorable. Another favorable aspect to our financials this quarter is the update on our gross to net retention. As payer coverage has improved, the trend in our gross to net yields has progressed as we anticipated. Our GTN retention moved from about 70% in the fourth quarter of 2024 to the mid-60% range in the first quarter of 2025 and now to the low 50% range in Q2. This progression reflects the success of our payer access strategy with an increasing volume of neffy prescriptions now covered without prior authorization and therefore, eligible for rebate payments under our payer contracts. We have previously guided to a steady state gross to net retention of approximately 50%, which we reached in the second quarter. Looking ahead, we expect our gross to net retention to be maintained around this level, providing greater predictability in future revenue modeling. Lastly, on our cash position, maintaining a strong balance sheet with over three years of operating runway remains foundational to our corporate strategy, enabling us to advance our commercial efforts with focus and stability. We ended the second quarter of 2025 with cash, cash equivalents and short-term investments of $240.1 million. This balance sheet strength means we are well positioned to fully capitalize on the U.S. commercial opportunity for neffy while maintaining financial discipline and resilience in a dynamic market environment. With that, I'll pass the call back over to Rich.

Thank you, Kathy. As we move into the second half of 2025, we remain focused on our top priorities. First, sustaining and accelerating market share growth through the peak back-to-school season, driven by our DTC investment in the coming weeks and months. Second, enabling neffy's global expansion through the international launches across our partner network, including in the U.K. later this year; and finally, advancing our urticaria program towards a potential label expansion. We are fundamentally changing the treatment of type 1 allergies; the barriers that kept patients from carrying and using epinephrine before, including the fear of needles, device complexity, portability, and shelf life concerns are gone with neffy, and its delivery is easy for both patients and caregivers. Backed by neffy's growing awareness and adoption in the United States, expanding global reach, and our advancing pipeline, I believe we're well positioned to deliver both near- and long-term value for our stakeholders and improve outcomes for patients worldwide. Thank you for your continued support. Operator, please open the line for questions.

Our first question comes from Lachlan Hanbury-Brown with William Blair.

Congrats on the progress. First question would be, can you confirm sort of the number of prescriptions written or shipped during the quarter? And second, it sounds like you're seeing encouraging progress on DTC in terms of awareness. Wondering if there's any early signs that you can see that this is translating into actual sort of prescribing behavior, either from doctors and patients asking for it or anything along those lines?

Yes, Lachlan. Rich Lowenthal. So yes, I mean, with regards to number of prescriptions, you can calculate it. We have $12.8 million in net sales and gross net was roughly 52%. So it's about 35,000 prescriptions in the quarter, in packs, two packs, I should say. Some prescriptions are for two or three two packs, but 35,000 two packs. And then that compares to 19,000 in the first quarter. And with regards to the DTC campaign, so really the linear TV, which tends to give the greatest impact on sales started beginning of July. And normally, the norm in the industry is 12 to 16 weeks to start seeing significant impact from that return on investment. But we are getting a lot of feedback. Certainly, a lot of people, even just people that are trying to find the case are mentioning the ads, the DTC campaign and seeing the neffy carry case in the ad and they want to know how to get it. So we get a lot of feedback like that, that people are definitely seeing the ad. They're definitely acting on it. And again, it takes a few months to get an appointment if you're a naive patient; maybe you have an appointment scheduled, but we're hoping that start to translate to significant uptick in the near future. But we would expect it to take 12 to 16 months to start seeing significant impact.

Got it. Eric, you mentioned that some patients who previously stopped filling their prescriptions are coming back to fill prescriptions for neffy. Can you provide insight into whether this is just an isolated case or if you're observing a consistent trend?

Yes, I can take this one. So it's still very early to kind of break all the data out. We do plan on doing a pretty extensive claims analysis in the fourth quarter end of the year. But the feedback that we're hearing, and I interact quite a bit with our field team and physicians, is it really is a mix of patients that are switching. Those are patients that are also reengaged because now they have an option that is needle-free, easy to carry and obviously less invasive. But we're also getting patients that, to your point, are lapsed that really opted out because of the needle. So we see that kind of across the board and feedback from all physicians and kind of what we're seeing from our field feedback as well.

Our next question comes from Roanna Ruiz with Leerink.

Congrats on the remarkable progress in commercial coverage. Just one on that. So the CVS Caremark is acquiring the prior auth for some payors under Zinc. What's the realistic ceiling for coverage without prior authorization? And would you be able to quantify the revenue impact of moving that remaining Zinc portion over to full coverage?

Yes, I'm not sure what you're asking regarding the ceiling.

Ceiling in terms of commercial coverage. Do you expect that 93% is the peak? Or do you think that there's still room to grow?

Yes. I hope I'm addressing your question accurately. About 25% of the CVS companies under CVS Caremark are providing coverage for neffy without requiring prior authorization. The remaining companies do require prior authorization, but none within the Zinc network are preventing access to neffy or asking for a medical exception. As we improve coverage without prior authorizations, it allows doctors to focus on obtaining prior authorizations for the companies that still require them. We haven't observed any indications of a ceiling. The number of prior authorizations remains relatively stable, but they are mostly focused on the companies that do not offer coverage without prior authorization and lack open access. This is our current situation. I'm not sure if that fully answers your question, but I hope it helps.

Our next question comes from Andreas Argyrides with Oppenheimer.

Congrats on the quarter, guys. I'll try to keep it to one question here. So we're seeing strong growth in weekly scripts, which of the many levers do you see driving the inflection point in the second half of the year? And then maybe one follow-up.

Well, certainly, the DTC campaign, Andreas, is going to be a major driver. We also, as we mentioned in our talk, expanded the sales force with the partnership with ALK. So they're focused on the pediatricians, the ones that are prescribing. We think that will help dramatically. I mean it's adding 10% reach to our current market force, about 55% overall. So we think those are really the major drivers. I mean, seasonality, we mentioned, but that's kind of routine and that's going to happen regardless. I mean, there's just an increase in the overall number of scripts over the summertime. But really, what we think are the big drivers are the DTC campaign to start raising awareness, not only among patients and caregivers, but among physicians too. So even the physicians that we don't reach, hopefully, will see these ads and realize there is a new product and research it. And then obviously, that sales force expansion. And we'll continue to evaluate things as we go forward as to what else we can do, given our cash position, we have a lot of flexibility, and we'll continue to evaluate things as we go forward.

Could you remind us how long you plan to run the DTC campaign? Also, how is the back-to-school season affecting scripts? Additionally, do you have any thoughts on patients possibly getting multiple packs during this back-to-school period, considering the convenience and various settings like home and car?

Yes, with the DTC campaign, we are currently budgeted and may even consider increasing the budget for this year, with plans in place for next year as well. We expect the campaign to continue at a similar pace, although there may be some seasonal slowdowns during holidays. This trend should persist through 2026, and we will keep evaluating the impact as we receive data on the effectiveness of our DTC efforts. We have reliable partners for data collection, which will help us focus on the most effective channels, potentially justifying an overall budget increase. Regarding orders, we are noticing a significant number of requests for two or three packs of neffy, along with case orders. This indicates a positive trend as customers seem interested in purchasing multiple packs. However, I'm unsure if we have specific statistics on that at this time since we are still in the early stages. Additionally, we've observed that customers initially in cash-based situations tend to buy one pack easily, but once they have insurance or meet their deductibles, they return for additional packs. Eric, do you have anything to add?

Yes. Andreas, we track kind of these numbers, and I can tell you that what we're seeing in terms of number of cartons devices per patient for that initial prescription is slightly higher than what we've seen previously in the market. So these are things that we continue to drive our field teams to the points you made, especially with kids. Parents want the kids to have one with them at all times. They want to have one in the house, just in case. So as Rich said, we are seeing multiple packs. It's messaging that will continue to drive. And there's a lot of programs, too, that we're doing through neffyconnect, but also even at the point of purchase, if a patient goes in and is covered. One thing that we updated a few months back was that we'll just charge one co-pay of $25 for multiple cartons. So again, we see this as an opportunity to drive that even higher in the months to come. But definitely, really nice increase that we're seeing over the last couple of weeks and months in terms of the number of cartons per prescription.

Our next question comes from the line, Ryan Deschner with Raymond James.

Congratulations on the quarter and the script growth. I wanted to ask, how are you thinking about the timeline for feeling the full impact of the DTC campaign ramp, expanded reach from the ALK promotion, and availability of the 1 mg neffy? And do you feel like these factors have come online quickly enough to fully take advantage of the August epinephrine peak? And will these factors still be enough of an acceleration mode to potentially even sustain quarter-on-quarter growth in 4Q despite seasonality? And then...

Yes, Ryan, I'll start with that. The usual timeframe is 12 to 16 weeks, but we understand that given the peak in August and September, we anticipate that the increased awareness will have an effect during that time, as many people have already scheduled their appointments. The delay in the impact of the direct-to-consumer campaign is primarily due to the need for consumers to see the ad several times, reflect on it, conduct their research, and then take action. Particularly in the allergy market, there's often a three-month wait to get an appointment. So, once they’ve seen the ad enough times and decide they're interested in scheduling an appointment, we know that many, especially children, will have already made their appointments ahead of time during the summer. We expect to see a positive impact and believe this will support us in having a strong second half of the year. Sorry, what was your second question?

Yes. Will these factors be enough really to be in enough of an acceleration mode to sustain quarter-on-quarter growth in 4Q despite that seasonality? And then I also wanted to ask, what would you consider the biggest indicators going forward that neffy is starting to make meaningful bites out of the larger blue sky market that doesn't regularly carry or use epinephrine?

Yes, I am confident that our quarter-over-quarter growth will continue. To answer your question, we haven't conducted a detailed market analysis on the sources of prescriptions yet. However, we have heard anecdotal evidence that many people who have never used an auto-injector are purchasing neffy. This includes some investors who are allergy patients and have avoided auto-injectors but have chosen neffy instead. Most of our current insights are anecdotal, but there seems to be a healthy mix of customers from various segments. The easier switchers are those already familiar with epinephrine and are simply looking for an alternative to their current auto-injectors. Anecdotal feedback suggests there are customers coming from all segments. As mentioned, we plan to perform a more thorough market analysis later this year after achieving a specific market share, which will enable us to better understand where our patients are coming from.

And I'm not showing any further questions at this time. And as such, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.