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Date

Monday, Nov. 10, 2025 at 8:30 a.m. ET

Call participants

  • Chief Executive Officer — Richard Lowenthal
  • Chief Commercial Officer — Eric Karas
  • Chief Financial Officer — Kathleen Scott

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Takeaways

  • U.S. Net Product Revenue for Neffy -- $31.3 million, a 2.5-fold increase quarter over quarter, exceeding consensus expectations of $28.3 million.
  • Total Revenue -- $32.5 million, consisting of U.S. net product revenue, $1.1 million in supply revenue from partners, and $100,000 in royalties related to YERNEPI in Germany (royalties recorded to financing liability, not P&L).
  • Market Share Amongst New Prescribers -- 10.3%, surpassing market share among existing prescribers with the same call frequency.
  • Healthcare Provider Adoption -- Over 18,000 healthcare providers have prescribed Neffy, an 85% increase since August; 81% of prescriptions originated from top decile seven through ten prescribers.
  • Pediatrician Penetration -- Approximately 9,000 pediatricians reached, with ongoing market share growth in this segment.
  • Neffy Schools Program -- About 6,500 schools have opted in, enabling access to emergency doses at no cost.
  • New Patient Segments -- Among patients prescribed Neffy, 19% were lapsed patients and 7% were previously untreated, highlighting expansion beyond traditional epinephrine users.
  • Patient Satisfaction -- 87% of Neffy patients report a positive impact on daily and social life; 95% indicate likelihood to refill compared to 30% actual rates for needle injectors.
  • DTC Campaign Effectiveness -- Consumer awareness rose from 20% pre-campaign to 56% by September; 80% of surveyed patients report they are very likely or extremely likely to ask providers about Neffy.
  • Gross-to-Net Performance -- Gross-to-net retention was modestly higher quarter over quarter as cash prescriptions decreased from about 20% to approximately 12% of volume; expected to remain in the low to mid-50% range despite the $0 co-pay program.
  • Back-to-School Seasonality Impact -- Temporary pause in market share growth due to compressed physician time and increased prior authorization needs; management characterized this as a one-time event.
  • Inventory Dynamics -- Distributors tended to maintain between 15 and 20 days on hand; Q4 sales are expected to decline sequentially, partly due to inventory reduction and seasonal epinephrine market contraction.
  • Get Neffy On Us Program -- Enables patients to initiate prescriptions and refills virtually at no cost if covered, designed to boost year-round adoption and address in-person prescribing bottlenecks.
  • Global Expansion Milestones -- YERNEPI launched in Germany; slope of market share capture there is triple that of initial U.S. trajectory due to seamless prescribing; UK launch underway; Japan approval received with 2025 launch planned; Canada and China launches expected 2026.
  • Phase 2b Urticaria Clinical Development -- Enrollment ongoing; top-line data expected in 2026 targeting 2 million U.S. patients, with over 60% adoption potential among chronic spontaneous urticaria (CSU) patients per market research.
  • Term Loan Facility -- Up to $250 million facility secured with initial $100 million drawn, featuring SOFR plus 5.5% interest rate, no equity dilution, and interest-only payments through September 2030.
  • Cash Position -- $288.2 million in cash, cash equivalents, and short-term investments as of quarter end.
  • Net Loss -- $51.2 million for 2025 year-to-date, or $0.52 per share.
  • U.S. Epinephrine Market Value and Growth -- Estimated at $2 billion annually (at Neffy net price), previously growing 6%-8% organically; 9% year-over-year and 8% year-to-date expansion reported in 2025 with Neffy contribution.
  • Prior Authorization Status -- About 50% of covered lives require some form of prior authorization for Neffy; within commercial coverage, 57% of prescriptions do not require prior authorization.

Summary

The earning call delivered details of an inflection quarter for ARS Pharmaceuticals (SPRY +0.56%), highlighted by a 2.5x quarter-over-quarter leap in U.S. Neffy net product revenue and outperformance relative to consensus estimates. New prescriber uptake and unique patient segment penetration contributed to momentum, while management outlined deliberate steps to mitigate physician burden and seasonality. International rollouts and imminent label expansion in urticaria were underscored as immediate drivers of future revenue streams. Capital structure flexibility was reinforced by a substantial, low-dilution debt facility, and operational investments prioritized direct-to-consumer and access initiatives intended to reinforce durable growth.

  • CEO Lowenthal said, Looking ahead to Q4, market share growth has resumed. Although we anticipate Q4 sales will decrease from Q3 given the overall epinephrine market typically declines about one-third due to seasonality and the holidays.
  • Chief Financial Officer Scott confirmed, Our current cash position is expected to be sufficient to achieve cash flow breakeven without additional equity financing while maintaining the resources needed to fully capitalize on the U.S. commercial opportunity for Nephi and benefit from the continued U.S. growth and expanding international revenue.
  • Management reported the slope of YERNEPI’s market uptake in Germany during initial months was three times higher than what we've seen in the U.S,
  • Scott stated the term loan’s cost of capital compares favorably with peer commercial-stage financing, and features interest-only payments through September 2030.
  • Operational commentary emphasized that Neffy is expanding the total epinephrine market as well as taking share, based on 19% lapsed and 7% previously untreated patient capture.

Industry glossary

  • Chronic Spontaneous Urticaria (CSU): A persistent, idiopathic form of hives lasting more than six weeks, targeted in ARS’ Phase 2b trial for label expansion.
  • Gross-to-Net Retention: The percentage of gross sales ultimately realized as net revenue after deductions such as discounts, rebates, and co-pay assistance.
  • DTC (Direct-to-Consumer) Campaign: Marketing efforts directed at patients rather than healthcare providers, aimed at increasing product awareness and prescription demand.

Full Conference Call Transcript

Richard Lowenthal: Thank you, Justin. Good morning, everybody, and thank you for joining us to discuss what has been a pivotal quarter for ARS Pharmaceuticals, driven by the continued momentum of Nephi in the U.S. and around the world. The third quarter marks a true inflection point for our business. As you can see on Slide three, U.S. net product revenue for Nephi grew again quarter over quarter, reaching $31.3 million in Q3, representing a 2.5-fold increase from the prior quarter and exceeding consensus expectations of $28.3 million. This change reflects strong growth in new patient starts and overall demand for Nephi.

Surveys among Nephi users indicate that we can expect durable utilization and recurring refill behavior, trends that we expect will continue to build as both coverage and awareness expand. These results show that our multifaceted commercial strategy is delivering results. Later this month, our first analysis of real-world treatment outcomes from the Nephi program will be published in the Annals of Allergy, Asthma, and Immunology with a total of 554 patients treated. Findings show that about nine out of ten patients experiencing anaphylaxis were effectively treated with a single dose of Nephi, which is consistent with outcomes for epinephrine injections where either IM injection or EpiPen require a second dose approximately ten percent of the time to resolve the event.

Updated results in 680 patients were highlighted in an oral presentation at ACAAI and reinforced that Nephi delivers equivalent outcomes to injection products in real-world use. On top of a series of case reports also presented at ACAAI by independent physicians, we expect additional peer-reviewed publications in 2026 that will further validate Nephi's clinical experience with injection products. Before Eric reviews our commercialization details, there are two important topics I want to touch on today. First, why Nephi's revenue trajectory isn't accurately reflected in IQVIA script data. And second, what we've learned from recent market dynamics, including back-to-school seasonality.

Starting with IQVIA, as we've noted before, the weekly IQVIA rapid data, which are generally available on a paid subscription basis, provide a directional view of prescription activity but are not completely accurate and reliable measures of Nephi's true performance or market share. IQVIA data sets often exclude a number of channels that are central to our business, including certain retail, mail order, and specialty pharma volumes, as well as bulk purchases by institutions and clinics that buy directly through wholesalers. These additional sales are not accurately captured by IQVIA and are variable from week to week and thus cannot be predicted.

Turning to market dynamics, during the back-to-school season, allergists and pediatricians experienced a huge surge in patient visits, including checkups and support physicals. That higher patient volume means that HCPs have significantly less time per appointment, typically just five to seven minutes per patient, leaving little to no opportunity to discuss new treatment options or changing prescriptions. That challenge is even greater for patients who still need prior authorizations. As a result, in Q3, we saw a temporary pause in market share growth. Importantly though, we view this as a one-time event. Looking ahead to Q4, market share growth has resumed.

Although we anticipate Q4 sales will decrease from Q3 given the overall epinephrine market typically declines about one-third due to seasonality and the holidays. Then as we move into 2026, we expect to return to quarter-over-quarter growth as both market share and overall prescription volumes rise in parallel. To further drive adoption and accessibility, we recently launched our new Get Nephi On Us program at the getnephi.com website. This is an important initiative designed to help patients switch to Nephi year-round with a hassle-free virtual prescriber interaction at no cost to patients if covered by insurance. This program is anticipated to help accelerate sales growth year-round and circumvent the hectic back-to-school season. Eric will share more details.

But this program removes much of the patient and physician burden in prescribing Nephi by shifting the prescription, prior authorizations if needed, and patient training to our virtual physician system. Once patients are on Nephi, physicians can more easily manage refills electronically or patients can return to getnephi.com to get additional renewal prescriptions. Together with our broader DTC campaign, this initiative makes it simpler than ever for patients to experience the benefits of Nephi and represents a key driver of long-term adoption. In fact, we already have proof of what hassle-free prescribing can do for Nephi sales. YERNEPI was launched in Germany in late June, where there is a more seamless prescribing experience without additional HCP paperwork.

The slope of the market share capture just the first few months has been three times higher than what we've seen in the U.S., showing just how impactful growth can be when administrative burdens are not a barrier. This is also a strong signal for our global growth trajectory. Nephi received approval in Japan in September, with launch anticipated to start in 2025. We expect approvals in Canada by 2026, with launch expected in 2026, and we expect approval in China in 2026. We expect that as these launches begin, they will start to contribute to the total revenue and cash proceeds in the second half of next year as distribution scales across partner regions.

On the clinical front, enrollment is ongoing in our Phase 2b urticaria trial, and we are on track for top-line data in 2026. This indication represents a major label expansion opportunity in a 2 million patient market in the United States. Early market research with allergists supports that our nasal spray product, if approved, could be prescribed to more than 60% of all of their CSU patients, irrespective of whether those patients are on antihistamine, biologics, or combination therapy. Finally, in September, we secured an up to $250 million term loan facility, from which we drew down $100 million initially.

Strategically, we chose this structure in partnership with our largest shareholder over other capital vehicles to increase commercial investment and further strengthen our balance sheet without dilution. This reflects our confidence and that of our investors in Nephi's durable cash flow profile and long-term potential. Our planned investments are geared towards expanding the current market and improving adherence and refill rates, reengaging lapsed patients, and activating untreated patients, as well as converting the current $2 billion annual U.S. epinephrine market at Nephi's net price. With this financing, we ended Q3 with $288 million in cash, cash equivalents, and short-term investments, giving us even more flexibility to support our evolving commercial initiatives.

In summary, we're building momentum across every dimension of our business, from revenue growth and market share growth to access, real-world evidence, and global expansion, all while maintaining a strong balance sheet. I'll now turn it over to Eric to provide more detail on our U.S. commercial performance.

Eric Karas: Thanks, Rich. The fundamentals of our commercial execution continue to strengthen, and I'm pleased to share how our strategy is translating into tangible results. Starting with revenue drivers, our $31.3 million in U.S. net product revenue reflects not only traditional retail pharmacy prescriptions captured in IQVIA data but also institutional sales to universities and colleges, as well as retail orders from clinics and hospital networks. This quarter, we've observed modest improvements in gross-to-net retention, with cash prescriptions decreasing from about 20% to approximately 12% of total volume.

By offering cash prescriptions through BlinkRx and other directly managed programs and optimizing our co-pay buy-down program at the point of sale, we've gained greater control, which led to favorable gross-to-net performance and improved profitability. Our DTC campaign is also delivering meaningful engagement, as seen on slide four. Consumer awareness has climbed from 20% pre-campaign to 56% as of September, and intent to get Nephi remains high. Approximately 80% of surveyed patients say they are very likely or extremely likely to ask their healthcare provider about Nephi after learning about it. The early lift from the campaign aligns with benchmarks for promotionally sensitive brands, and we believe it will continue to improve as awareness grows.

To accelerate greater adoption, we're excited to introduce our Get Nephi On Us initiative, which is part of our direct-to-consumer campaign. As outlined in slide five, this program was designed to simplify access to Nephi. Patients can schedule a quick virtual visit with a prescriber to get started. Once prescribed, Nephi can be shipped directly to their home or picked up at the pharmacy of their choice, typically with a zero co-pay for most commercially insured patients. Importantly, patients are not required to wait for their current auto-injector prescription to expire. They can transition to Nephi immediately without the need for an additional appointment with their HCP.

By minimizing hassle, assisting with coverage and the prior authorization, and enabling straightforward auto refills, this program makes it easier than ever for patients to choose Nephi and stay protected. We've incorporated the Get Nephi On Us program into all of our DTC materials, and early survey feedback shows that a majority of patients are open to using the virtual prescriber option. We believe this initiative will encourage consistent prescription switches throughout the year, extending beyond the usual back-to-school period and maintaining growth even during traditionally low-volume months. We are also seeing meaningful expansion in reach and adoption.

Turning to slide six, to date, over 18,000 healthcare providers have prescribed Nephi, an 85% increase since August, with 81% of prescriptions coming from top decile seven through ten prescribers. Market share amongst new prescribers is at 10.3%, outpacing existing ones with the same call frequency, signaling faster uptake as new doctors benefit from refined messaging, an easier prescribing experience, and growing real-world evidence. These operational improvements are driving momentum and scaling our efforts. On the pediatric front, our 9,000 pediatricians, where our market share continues to grow. In addition, approximately 6,500 schools have opted into our Nephi Schools program, providing access to emergency doses at no cost.

Perhaps most importantly, we're seeing early signs that Nephi is expanding the overall epinephrine market, not just taking share. We're reaching new patient segments, as seen on slide seven. Amongst patients prescribed Nephi, approximately 19% were lapsed patients who had stopped filling prescriptions, and 7% had never filled at all despite being diagnosed. These patients who stayed away primarily due to needle anxiety or device complexity. In total, about a quarter of patients prescribed Nephi are from these new segments. As summarized on slide eight, patient satisfaction is remarkably high. Eighty-seven percent of Nephi's patients report a positive impact on their daily and social lives.

Ninety-five percent said they were likely to refill the prescription compared to actual refill rates of around 30% for needle injectors. The current epinephrine market is valued at $2 billion annually at Nephi's net price, growing at 6% to 8% organically prior to Nephi's entry and branded promotion. And this year, we've seen year-over-year growth at 9% and year-to-date growth at 8%. As both Nephi captures share and expands the market through improved refill rates, new patient adoption, and higher devices per patient, the opportunity is significant. In summary, our U.S. launch execution is progressing well, and we are gaining momentum.

We are excited about the ongoing investment in direct-to-consumer initiatives, the launch of the Get Nephi On Us program, discussions with payers, and our efforts in the field to increase market share amongst targeted HCPs. We look forward to driving growth. Our commercial infrastructure is optimized to scale sales rapidly through 2026. I'll now turn it over to Kathleen Scott to discuss our financials.

Kathleen Scott: Thank you, Eric. We continue to maintain a strong financial position while investing significantly in the commercial growth of Nephi. Looking at our third quarter 2025 financial results on Slide nine, starting with revenue. We recorded total revenue of $32.5 million. As we've discussed, it's important to look at U.S. net product revenue separately from collaboration and supply revenue. Our U.S. net product revenue for Nephi was $31.3 million, representing a near 2.5-fold increase from the prior quarter. We recognized $1.1 million in supply revenue from partners during the quarter. We also earned royalties of $100,000 from ALK related to the launch of YERNEPI in Germany.

In accordance with GAAP, these royalties were recorded to the financing liability on the balance sheet rather than our P&L. Turning to our operating expenses, R&D expenses for the third quarter were $2.8 million, primarily related to our ongoing Phase 2b urticaria trial and continued development expenses for Nephi. SG&A expenses were $74.8 million, reflecting our ongoing investment in our national DTC campaign and sales and marketing efforts. While SG&A spend increased with DTC expansion, these are deliberate investments designed to drive durable share growth with spend efficiency improving quarter over quarter. We remain committed to making substantial investments in Nephi to ensure both short and long-term market share capture and brand awareness.

Our gross-to-net retention in the third quarter was modestly higher than in the second quarter due to certain channel dynamics. Looking ahead, we expect gross-to-net retention to remain in the low to mid-fifty percent range even with the reduced $0 co-pay program. Net loss for 2025 was $51.2 million or $0.52 per share. Lastly, as of September 30, 2025, we had cash, cash equivalents, and short-term investments of $288.2 million. In September, we secured a senior secured term loan facility with RA Capital, our largest shareholder, and Obern's Life Sciences of up to $250 million, drawing an initial $100 million from this facility, which will be used primarily to accelerate Nephi's commercial growth.

The funding will also support our marketing and medical affairs initiatives to generate and disseminate real-world evidence about Nephi's effectiveness. This financing provides several strategic advantages. First, it's an attractive cost of capital at SOFR plus 5.5% with interest-only payments through September 2030, zero dilution, and terms similar to recent commercial stage deals such as Verona Pharma. Second, it comes from high-quality investors who understand our business and are aligned as long-term partners. Third, it maximizes our flexibility for commercial initiatives, including DTC campaigns and real-world evidence generation.

Our current cash position is expected to be sufficient to achieve cash flow breakeven without additional equity financing while maintaining the resources needed to fully capitalize on the U.S. commercial opportunity for Nephi and benefit from the continued U.S. growth and expanding international revenue. With that, I'll pass the call back to Richard Lowenthal.

Richard Lowenthal: Thanks, Kathy. As we look ahead, we remain laser-focused on our key priorities. First, sustaining and accelerating Nephi U.S. market share growth through the fourth quarter and into 2026. Second, enabling Nephi global expansion through launches in multiple geographies across our partner network. And finally, advancing our clinical stage urticaria program towards a potential label expansion. Our momentum continues to build across every dimension of our business, and we are confident in our path towards long-term growth and profitability. Most importantly, executing our mission of transforming how severe allergic reactions are managed and fundamentally impacting the lives of patients, families, and caregivers. Thank you for your continued support. Operator, please open the line for questions.

Operator: Thank you. We'll now begin the Q&A session.

Lachlan Hanbury-Brown: Hey, guys. Thanks for the question, and congrats on the quarter. I guess, yeah, first question is maybe just I know there were obviously some high expectations in Q3, and would be curious to hear how these results sort of stack up to your internal expectations heading into the quarter. Hello?

Operator: Rich and team, can you please come off mute? Please remain on the line.

Lachlan Hanbury-Brown: Awesome. Hey. I saw the first question was just, yeah. I know there was my expectation heading into Q3 with the back-to-school season. I was curious to hear how this performance sort of stacked up to your own internal expectations. And yeah.

Richard Lowenthal: Yeah, Lachlan. This is Richard Lowenthal. So I think the performance we've reported, obviously, was better than analysts' expectations, and we met our expectations. I mean, we've spoken a little bit about the difficulties over the summer and doctors' burden and why we are shifting a lot of our attention towards our Get Nephi On Us program, which physicians right now are giving us feedback that they're very, very positive about this approach. So we obviously would have liked to have seen a better performance over the summer. But I think it met our expectations. And I think we learned and adjusted very quickly to avoid the issue of the doctor burden problem that we experienced.

And I would just add too, as we stated in the prepared remarks, I mean, the growth of new prescribers and prescribers overall has been strong in Q3 and throughout the summer. As I mentioned also, you know, what we're seeing with that group of doctors too is, I think, just really focused messaging. You know, the real-world data and then some of the programs that we put in place. Is a higher share, so that's very encouraging. And then, you know, the increase that the consumer awareness with our DTC campaign continue to grow through the summer months.

Lachlan Hanbury-Brown: Yeah. So maybe on that point about the higher share in the newer prescribers, is that a higher share at a certain time after writing their first script or just an overall higher share among them than the original prescribers? And if so, maybe why are the initiatives that are getting higher share in the new prescribers not driving further share growth in the prior prescribers at the same rate?

Eric Karas: Rich, I can take do you wanna take that one?

Richard Lowenthal: No. No. You can take it. I don't I think as I mentioned, you know, the focus on kind of, you know, tighter messaging in terms of the unmet need, and not only the attributes of needle-free, but the totality of what Nephi offers. Continues to drive adoption and writing. I think as Rich said, you know, the volume of overall patients and kind of our core went up quite a bit in the summer. That's one of the reasons why, again, the Nephi program was designed to really help the offices and help the patients mean, if you look at our allergists, for example, our top you know, 4,000, I mean, the share is higher than the average.

I think we're seeing that kind of across the board where we have good focus, you know, reach and frequency, a tighter message, really focused market access messaging too. Our sales team is able to kinda see within a doctor's patient base the specifics around where Nephi is covered without a PA. And then really kinda sharing and educating those best practices has really kinda helped us with adoption that we see kind of, you know, with those physicians that I mentioned.

Richard Lowenthal: And, Lachlan, let me just correct one thing, because I think your what you stated is not really, the correct perception. The doctors that are prescribing Nephi at the higher tiers continue to expand their use, their market share continues to go up. We also expand the number of prescribers, but new prescribers tend to be trialing. Right? So new prescribers tend to be coming in. They try out Nephi with some of their patients. And once they have positive experience and they're comfortable, they start then expanding. So while we're seeing a good growth of new prescribers, those prescribers are not adding a lot to our market share.

But I don't want you to think that existing prescribers are decreasing. They're actually increasing. So when we look at our existing prescribers, they are increasing in market share. And the only reason that market share kinda took a dip over the summer is because the volumes get so large and a large percentage of that volume is renewal prescriptions, which are virtual. So they're not even going to see the doctor. So if we could look at just prescriptions that were at a doctor's office, I think we would have had a much higher market share of those prescriptions. But you have a lot of renewal virtual renewals going on before school starts.

And that we will take the advantage of next year, but this year, obviously, we don't have renewals of Nephi yet on an annual basis. So starting next year, we'll start to see the benefit of that virtual prescribing.

Lachlan Hanbury-Brown: Alright. Thanks. And maybe final one for me. The institutional sales the point you made was an interesting one. Can you just elaborate on maybe how much volume went through that channel, what the economics are like, how big that opportunity is, know, what you're doing to capture that beyond the traditional retail setting?

Richard Lowenthal: Yeah. We're not gonna elaborate on that today because it's inconsistent, obviously. And we are just starting up formal marketing efforts in that area. So we are now shifting some of our attention to market directly to buyers and also to provide both discounts and other incentives to them to start boosting those sales going forward. So it's not consistent enough yet for us to give you any kind of guidance, Lachlan. So we'd rather not give too much detail on that at this point.

Lachlan Hanbury-Brown: No. Makes sense. For the questions.

Operator: Our next question comes from Josh Schimmer with Cantor.

Josh Schimmer: Thanks for taking the questions. Apologies if I missed this in the prepared remarks. But what percent of covered lives now require some form of prior auth prior? What trends are you seeing there? And then for the online prescribing option, what is being done to raise awareness of patients if that is available to them? Thanks.

Richard Lowenthal: Yeah. So I'll take the latter part and then let Eric answer the part about the prior authorization and percent of prior authorizations. I think we are advertising already, so we started to incorporate the new program into our DTC. You will also shortly see new TV commercials, which use the same theme, so same background, same theme, but different voice-over and banners. In order to make it very clear to customers that we now have this virtual prescriber option, that we're it's no cost to the patient or caregiver. And, again, with commercial insurance, it's zero co-pay. So I think that is rolling out. I mean, I think virtual ads are already updated.

And then, also, we sent out, obviously, an email blast to all of our, everybody on our email list that has been on nephi.com. And, also, several of the large advocacy groups have put this out on their email list, that ARS Pharmaceuticals is now got the promotion going. Is paying for a virtual prescriber if they wanna skip the hassle of a physician visit and also that they can get a zero co-pay now and they can get multiple packs with zero cost. So it's more than just one box. It's multiple boxes. They can get whatever their insurer will tolerate. And just so you know, on that front, almost all insurers will tolerate two boxes in one prescription.

Some will accept three. Two packs in one prescription. So we are defaulting to two packs in the virtual prescriber prescription. Eric, you wanna talk about PAs?

Eric Karas: Yeah. Good morning, Josh. Thanks for the questions. Overall, when you look at the PA required, and this is through kinda commercial, Medicaid, and Medicare. It's about 50%. So that number has come down, as we've also shared too specifically within commercial. About 57% of prescriptions patients don't require a PA.

Josh Schimmer: Okay. Thank you.

Operator: Our next question comes from Roanna Ruiz with Leerink Partners.

Roanna Ruiz: Great. Good morning, everyone. So couple for me. Could you talk about the inventory levels for Nephi in the quarter and how we should think about it exiting for Q4? And secondly, I also noticed you talked a bit about IQVIA being a bit off in tracking Nephi prescriptions. Could you give us a little more detail about what portion of the scripts are flowing through IQVIA versus BlinkRx and other channels?

Richard Lowenthal: Yeah. Let me speak to that first, and then Eric can add on it. I think the inventory levels that the distributors are maintaining tend to be between fifteen and twenty days. It fluctuates, obviously, from week to week and period to period. They did they do build inventory for peak periods. And then, what would be normal is that they're gonna reduce down their inventory as the market drops in the fourth quarter. So as we said, that's part of the reason why we expect that the overall sales in the fourth quarter, although we believe we'll do very well, will come down from the third quarter. And part of that is driven by inventory adjustments as well.

So that dynamic is pretty fairly normal. But, again, this is a product with some seasonality to it. The distributors are well aware of that. So they do adjust inventory according to that seasonality. But they try they seem to be trying to maintain their inventory between fifteen and twenty days on hand. And, Eric, do you wanna speak to the other part of that?

Eric Karas: Yeah. I think, Roanna, good morning. Thanks for the questions. When you look at kind of the distribution of the prescriptions being filled, it's slightly higher kind of on the retail side. I think as we kinda transition more where, had higher, you know, coverage and so forth, doctors started sending patients directly to kind of a the local pharmacies, you know, because that was something easier for the patient to kinda pick it up. And get it right away. It's probably about 50, you know, 5% to 45%.

But as Rich mentioned and we mentioned, you know, some of the inaccuracies of, you know, capture rates and some of the other channels that, you know, we're selling medication to is not necessarily tracked in the IQVIA data overall.

Richard Lowenthal: Yeah. And it's very inconsistent, Roanna. So we can see that it from week to week or period to period, it's not very consistent what IQVIA is capturing.

Roanna Ruiz: Makes sense. A lot.

Operator: Our next question comes from Andreas Argyrides with Oppenheimer.

Andreas Argyrides: Hey, good morning, guys. Thanks for taking our congrats on the solid quarter here. Couple from us. There was a previous question around prior authorizations. You know, maybe, you know, what are some of the gating factors in reaching unrestricted access? What are your timelines? To add, let's say, CVS Caremark, Aetna, and etcetera, bigger formularies in '26? And how do you anticipate those improvements contributing to growth next year? And then I got one or two follow-ups.

Richard Lowenthal: Yep. So, Andreas, I'll start out with the answer on that. So, we continue to work, obviously, with Zinc and Caremark, CVS. We do have some new proposal in with them. So we're very optimistic. What the timing of that, we cannot be sure of right now. We believe that it will be in the first half of next year that they will put it on formulary with preferred status, but we're also working with them to possibly remove the PA requirement even as nonpreferred sooner than that. But we can't really promise because CVS is not consistent in their behavior.

And we know that in the past when we had an agreement with Zinc, CVS did not follow through with that. So we are working with them. They seem to be working with us, and Zinc certainly is very, very positive. But we have to just wait until we get through that. But we do have a new proposal in with them, and we are talking fairly regularly with Zinc and CVS groups. On the other side, we also are working with Prime and other Blue Cross companies. That's the other piece that we're focused on. And we are making progress in that regard as well. And also with Anthem, which kind of follows Caremark but is independent of Caremark.

Andreas Argyrides: What do you think I mean, so what do you think some of the considerations that these payers look at when they decide to make their decisions? What are some of the data points that you guys are bringing to their attention?

Richard Lowenthal: Yeah. Well, they see the market growth. I think they understand the medical value. At least most companies understand the medical value of Nephi. And I think it's just a matter of and it's a little different for different companies. I think it's you know, with CVS, there's a little bit different focus on the revenue that they would generate. For the Blue Cross companies, I think it's just managing their premiums and managing their cost. So they tend to be delaying coverage for that reason even if they recognize the medical value. And then there's a handful of companies that are just not covering for other reasons.

But it tends to be just managing their costs, and we need to work through that with them.

Andreas Argyrides: Okay. Great. And I know you guys aren't necessarily giving guidance here, but just given the strong momentum in Q3, how are you thinking about Q4 sales and then growth into next year? Thanks.

Richard Lowenthal: Yeah. As we said, I mean, you know, Q4 will probably be less than Q3. And I think that's anticipated to some extent even in the analyst estimates. We will continue to grow market share, and again, depending on how well the Get Nephi On Us program does, and how much business that drives, will probably dictate whether we are well above consensus or not. But I think that program hopefully will solve some of the headwinds that we have been seeing, and then if we can make more progress on access, but that will probably be in the first or second quarter of next year. That will certainly also add to the momentum at that point.

Andreas Argyrides: Okay. Great. Thanks for taking my questions. Congrats on the quarter again. Thanks.

Richard Lowenthal: Alright. Great. Nice to talk to you.

Operator: Our next question comes from Kevin Holder with ROTH Capital Partners.

Kevin Holder: Good morning. Thanks for taking our questions. First one for me, I think I know you launched in the UK with ALK a few weeks ago. You know, just some commentary on the adoption there. And is it tracking more towards, you know, the growth trajectory in Germany or close to the growth trajectory in the U.S.? I know a little bit early stages there, but just some commentary would be helpful. Thank you.

Richard Lowenthal: Yes. So, yeah, it's a little early to say. It's a little early to say, but what I can tell you is that I think the UK physicians and patients' caregivers are very excited about Nephi. I think we expect a very good performance. And, again, they have a more seamless reimbursement process than the U.S. So we know that they get fairly well covered, very quickly or they are already being well covered. So we do expect adoption. I would expect at least at this stage, again, too early to be sure, I would expect adoption to be more like Germany, more because of the very rapid access that they get in those countries.

Kevin Holder: Thank you. That's very helpful. And then just one last one for me. I think in the slide deck, you show that you're targeting 9,000 pediatricians with the ALK U.S. Salesforce. Kind of what is your progress there thus far? And you know, penetrating that market?

Eric Karas: Yes. Hey. Good morning. We're seeing a nice increase through the summer months when that team went into the field. Of share. So we track a couple things in terms of overall volume, new prescribers, and that is progressing nicely. Obviously, we wanna kinda see that continue growing at a pace here in Q4 as well. But we're pleased to get to overall about 20,000 physicians. So we're hitting all of those big allergists, the deciles eight through ten, but then we've been able to expand to about another 9,000 pediatricians that also see patients that need epinephrine.

Kevin Holder: Great. Thank you very much, and congrats on the quarter.

Operator: Our next question comes from Ryan Deschner with Raymond James.

Anthony: Hi. This is Anthony on for Ryan. Thank you for taking our question and congrats on the quarter. So we wanted to know how are you thinking about the impact of the virtual program over the next several months? And what's patient demographics do you think will have the biggest impact from this program?

Richard Lowenthal: Yeah. I'll start out, and Eric can add to what I say. We are very excited about this program. We've had a prescriber option on our website, but it wasn't very well utilized only because of the fee and because of, again, us not promoting it. Right? We were not advertising it. Feedback I got, I was just at the American College of Asthma Allergy Immunology, is that the doctors are actually looking at this as a really positive thing. Mean, doctors, allergists especially, are exceptionally busy. They're under a lot of pressure to see as many patients as they can.

And the time it takes to counsel patients on a new drug and switch them takes up a lot of their time. So by introducing this program not only to the patients and caregivers but to the doctors, the doctors are coming back with a very positive attitude towards it that they can actually talk to their patient and then switch them over to getnephi.com and we would take care of the rest. We would take care of the description, a PA if necessary, training, everything for the patient so that burden is removed from the doctor. On top of that, patients and caregivers will now have the opportunity to get Nephi without a waiting time.

Typical waiting time to see an allergist is three to six months. They don't need to travel down to the doctor's office and sit in the doctor's office. And it's fairly quick, so there's also probably less dropout because you're gonna have a very quick interaction virtually, and then the prescription goes to the pharmacy or gets filled through the mail order system. And it's gonna go really, really quick. So less chance of a patient deciding that they changed their mind or don't wanna go to the doctor. Cancel the appointment for other various reasons, like, for reasons. So we expect it to have some meaningful impact. I mean, how much impact we can tell you.

But I think the positive response of the doctors we're getting has been very reassuring because they see it as a way for them to switch their patients without having to take up too much of their time. But I think that's an important aspect in today's world when they're under pressure to see just one more patient each day. Eric, do you wanna add anything?

Eric Karas: Yeah. I need a couple points to build on what Rich mentioned. As Rich said, we were just at the college conference, and even before the conference started, we did an advisory board with about 12 physicians. Things that we went through is this program, and the response was very positive. So we will see how obviously, we're watching really closely and we mentioned earlier too, making sure we're promoting this through our DTC efforts as well. Then we've also done market research specifically with caregivers, parents, and patients. And as Rich mentioned, they see this as time savings. Making the product really easy to get.

You know, the ease of use, the cost aspect of not having to pay, you know, lower co-pay. And then just over the product overall, I mean, you start thinking about the unmet need and the patients kinda see this again needle-free, the temperature excursions, the simplicity, ease of use. The feedback that we're getting again from across patients and parents about this program has been positive.

Anthony: Alright. Thank you very much.

Operator: That concludes today's question and answer session. This will conclude today's conference call. Thank you for participating. You may now disconnect.