ARS Pharmaceuticals (SPRY) 2026 年第二季法說會：neffy 市佔率提升與成本重置

重點總覽

• ARS Pharmaceuticals 公布 2026 年第二季總營收為 3,370 萬美元，其中包括美國 neffy 產品淨營收 2,620 萬美元。
• neffy 在美國的總市佔率達到 5%，高於去年同期的 2.5%。在外勤銷售目標客戶中的市佔率自 4% 上升至 8%，而在非目標客戶中的市佔率約為 1%。
• 本季有超過 1.6 萬名獨立醫療照護提供者開立 neffy 處方，是去年同期紀錄的三倍以上。
• 管理層正將商業投資方向從廣泛的直接對消費者 (DTC) 廣告，轉向與高價值處方醫師進行高頻率互動，這些醫師占總市場機會的 44%。
• 2026 年下半年的現金銷管與研發費用預計總計為 1 億至 1.1 億美元。管理層表示，調整後的成本結構有助於在 2027 年底前實現現金流損益兩平。
• 由於患者需要時間記錄三次獨立的發作，鼻噴型腎上腺素用於治療慢性原發性蕁麻疹 (CSU) 的 2b 期中分析數據現預計於 2027 年第一季公布。

關鍵財務數據

業務與營運表現

ARS Pharmaceuticals 正重組 neffy 的商業化策略，將重心轉向醫療照護提供者，而非廣泛觸及消費者。管理層將腎上腺素急救市場描述為以預防為導向，因為處方是在過敏事件發生前開立並配藥的。這對改變長期以來使用針頭式自動注射器的處方習慣造成了阻力。

公司表示，外勤互動已帶來明顯成效。neffy 在外勤目標領域擁有 8% 的市佔率，而在未部署銷售團隊的區域僅約為 1%。ARS 已完成外勤銷售團隊的擴充，將主要專注於最高價值的處方醫師，這部分占整體市場機會的 44%。

商業保險涵蓋率目前達到 90%，其中 57% 無需事先審查即可獲得。管理層表示，擴大保險涵蓋範圍固然重要，但處方集進入權必須與醫療提供者更強的信心結合，才能穩定轉化為實際處方。

ARS 將保留透過社群媒體和搜尋等管道進行更具針對性的消費者推廣，同時遠離廣泛的傳統電視和閉路電視宣傳活動。管理層預期此方法可在不犧牲營收成長的情況下提升商業效率。

公司同時預計，第三季處方量將受益於開學季，同時繼續維持以醫療提供者為核心的同一策略。

管理層指引

ARS 預計 2026 年下半年的銷管與研發費用合計為 1.14 億至 1.26 億美元。受現金銷管費用較 2026 年上半年減少 40% 以上驅動，現金銷管與研發費用預計為 1 億至 1.1 億美元。

管理層預計支出較低的趨勢將持續貫穿 2027 全年。基於更嚴格的費用控制以及預期營收與市佔率的季增與年增，公司看到了在 2027 年底前實現現金流損益兩平的途徑。

隨著 ARS 精簡製造流程並擴大生產規模，毛利率預計隨時間改善，特別是在 2027 年。管理層也預計市佔率將在未來數季穩定成長，而非出現即刻的跨越式暴增。

風險與關注焦點

• 要改變醫療提供者數十年來對自動注射器的依賴，預計需要與醫師、護理師和醫療助理進行反覆互動。
• 總額至淨額率可能會根據支付方與客戶群體的組合而有所波動。
• 第二季毛利率受到效期較短產品備抵準備、製造效率低下以及美國以外地區產品上市相關成本的限制。
• 儘管商業保險涵蓋範圍廣泛，但僅有 57% 無需事先審查，這為部分患者帶來了給付核銷方面的障礙。
• CSU 2b 期中分析數據公布時間已延至 2027 年第一季，因為患者必須經歷並記錄三次獨立的發作才能收集到有效數據。

分析師問答重點

管理層表示，在目標客戶群中更高的滲透率應來自完全部署的銷售團隊、診所層面的反覆互動，以及強調「不採取行動後果」的訊息傳達。處方量與市佔率仍將是主要的績效指標，並輔以銷售活動和拜訪頻率數據。

在支付方覆蓋方面，ARS 將繼續努力擴大商業保險與醫療補助 (Medicaid) 的涵蓋範圍。然而，管理層強調，取得保險覆蓋只是第一步，改變醫療提供者的行為才是新商業策略的核心。

關於獲利能力，管理層將 2027 年底實現現金流損益兩平的目標，主要歸因於銷管費用的減少以及 neffy 營收與市佔率的持續成長。公司表示目前的總額至淨額假設已納入該展望中。

ARS 還於 7 月簽署了一項許可協議，取得某些智慧財產權的全球權利。管理層將其描述為潛在的系列產品延伸機會，但表示現在提供更多細節還為時過早。

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管理層陳述

Operator

Thank you. Good afternoon and welcome to ARS Pharma's second quarter 2026 earnings conference call. At this time all participants are in a listen only mode. After the company's prepared remarks we will open the line for questions. Please be advised conference is being recorded. I will now turn the call over to Monique Allaire, IR representative for the company. Please go ahead.

Unknown Speaker

Good afternoon and thank you for joining us. With me on the call today is Don Casale, President and CEO of ARS Pharma. Kathy Scott, our Chief Financial Officer, will join us for the Q&A session. Earlier today, we issued a press release outlining ARS Pharma's corporate priorities and commercial highlights and detailing its financial results for the second quarter of 2026. That press release can be found in the Investors and Media section of the company's website at ars-pharma.com. Before we begin, please note that today's remarks may contain forward-looking statements and actual results may differ materially. Please refer to our press release and SEC filings for further risk disclosures.

With that, I'll turn the call over to Don.

Donn Casale

Thank you, Monique, and good afternoon, everyone. It's an absolute honor to host my first earnings call as CEO. This is a pivotal time for ARS Pharmaceuticals, and I look forward to sharing my strategic vision today, along with the corporate priorities that will drive our next chapter of growth. Over the past month, I've conducted a deep review with our commercial, clinical, and corporate teams and met with many of our investors and shareholders. Those conversations confirm both the significant market opportunity ahead and the need for a disciplined operational approach going forward. Today, I want to walk you through how I see the business, what's working, what's changing, and what to expect from ARS. What I am outlining is more than a shift in our commercial strategy.

It is a fundamental change in how we manage our business and allocate capital. Against that backdrop, I'm laying out three strategic priorities that will guide our next phase. First, targeted provider commercial execution. We are prioritizing our resources and focus where they make the greatest immediate impact on NEPI market share, the healthcare provider. Second, financial discipline. We are implementing a rigorous strategic cost optimization framework, significantly reducing SG&A expense, with a focus on building a profitable Netflix franchise with a predictable path to cash flow break-even. And third, pipeline expansion starting with chronic spontaneous urticaria or CSU. We are extending our intranasal epinephrine platform into a second large market, where we see significant opportunity to bring the first FDA approved treatment for CSU acute flares. CSU addresses a critical unmet need and offers a compelling market expansion opportunity.

Let me expand on the first strategic priority in more detail, targeting provider commercial execution. NEFI should be the standard of care in this multi-billion dollar market. Our primary objective is to increase market share, which we believe is the best indicator of commercial success for a product like NEFI. Starting this summer, we will report on both total market share and share within our field-targeted call universe so you can track our progress directly. To level set where we are today, second quarter U.S. net product revenue was $26.2 million and total U.S. market share reached 5%, doubling from 2.5% in the same period last year. Importantly, within our field sales targeted universe, market share increased to 8%, up from 4% in the prior year quarter. Additionally, we saw over 16,000 unique NEPI prescribers in the second quarter, representing more than a three-fold increase from the same period last year.

NEPI is an acute life-saving rescue therapy, but unlike a traditional product that a patient takes to treat a condition, the nephias prescribed, filled, and carried long before an event ever occurs. In commercial terms, this is more like a prevention-based market versus a treatment market. That distinction is critical. In a treatment market, a patient is symptomatic and actively seeks immediate relief. In the prevention market, patients and providers default to the status quo unless there is a compelling reason or need to change. At launch, ARS invested heavily in broad, direct-to-consumer digital advertising. While that builds brand awareness, consumer advertising in a prevention-based market carries a high cost and does not always convert to utilization. Today, millions of patients remain inadequately protected, either because they were never offered a prescription or due to the fear or hesitation of carrying traditional needle-based injectors.

That is the exact clinical gap NEPI saw. The closing the gap relies less on broad consumer awareness and far more on changing long established provider prescribing habits. Going forward, we have an opportunity to drive market share growth with a more efficient commercial strategy, but not at the expense of revenue. We are prioritizing our investments where they deliver the highest return. Our sales team calling on high volume locations to build provider conviction, office by office. Our data highlights the impact of field engagement. Where our sales team is deployed, NEFI has an 8% market share. to approximately 1% in the non-targeted universe.

Growth in this market is won through repeated high-quality clinical interactions. not through a single promotional campaign or market event. On the topic of reimbursement, we will continue to aggressively work towards expanding commercial and Medicaid coverage. Securing formulary position is the first step. Beyond that, providers must appreciate and acknowledge the clinical gap NEPI fills before coverage translates into prescriptions. Building that provider conviction is our highest operational priority. Executing this strategy requires leadership that understands the nature of a prevention-based market and what it takes to change prescriber behavior. That's why I'm thrilled to welcome Meg Smith to ARS as our new Chief Commercial Officer.

A dynamic commercial leader with over 25 years of executive experience, Meg brings a proven track record of combining disciplined investment with deep operational accountability. Having worked closely with Meg during my time at Dynavax, I saw firsthand her inspirational leadership and operational rigor. She brings the exact playbook needed for this market, and I'm confident she'll hit the ground running leading this next chapter of the MEPI launch. In addition to strengthening our commercial leadership, we have completed the expansion of our field sales organization. Salesforce efforts will focus primarily on the highest value prescribers, which represents 44% of the total market opportunity. I look forward to seeing what our now fully deployed, highly motivated, and focused sales team can do going forward. Looking ahead, we expect steady market share gains over successive quarters, not an overnight We are focused on driving the next phase of growth with disciplined commercial execution, clear accountability, and prudent expense management.

That brings me to our second strategic priority, financial discipline and greater OpEx control. Our total revenue in the second quarter was $33.7 million, reflecting a combination of net product, collaboration, and supply revenue. Total operating expenses were $95.1 million, which included $12.8 million in cost of goods sold. As discussed, our prior commercial strategy emphasized broad consumer awareness, which was costly, resulting in an SP&A spend of approximately $77.6 million for the second quarter. It is critical that we adjust our operating expenses to align with NEPI adoption to build a durable, profitable business. To get there, we will plan and spend based on reasonable expectations and more efficient commercialization efforts. To give a clear baseline for our future run weight, we've adjusted our aggregate SG&A and R&D expenses for the second half of 2026 to be able to cover the cost of the current in the range of $114 million to $126 million, which includes stock-based compensation of about $14 million to $60 million.

As a result, total cash-based SG&A and R&D expenses for the second half of 2026 are expected to be in the range of $100 million to $110 million, driven by a more than 40% reduction in cash-based SG&A expenses from the first half of 2026. Importantly, we expect this spending trend to continue throughout 2027. We believe this operational rigor is what makes our outlet predictable. We ended the second quarter with $143.8 billion in cash, cash equivalents, and short-term investments. With that capital, alongside our revised expense base, we see a path to cash flow break-even by the end of 2027, would position NEFI to be a foundation for long-term optionality and future value in lock for shareholders. Part of that value unlock will come from our third strategic priority, advancing our CSU program and maximizing the opportunity with our intranasal epinephrine platform. Beyond our foundational business with NEPE, we believe we possess a compelling upside with our CSU program.

Personally, I'm very excited about this opportunity. To start, we previously projected a data readout from our Phase 2b trial by the end of this While enrollment in the interim patient population was recently completed, the design of this trial required a patient to experience and log three separate FLIR episodes. treating them with placebo and varying doses of intranasal epinephrine. Given the real-world time required for patients to complete all three episodes for valid data collection, the interim read-up is now expected in Q1 2027. This model's change in timeline does not change the value of this program. CSU is a meaningful market with a major unmet public health need. There are currently no FDA-approved on-demand products to manage acute CSE flares, representing a clear expansion opportunity. Epinephrine's role in rapid systemic symptom relief is well established.

The challenge in the past has never been the molecule. then the delivery mechanism and the dose. This is where our intranasal technology changes the dynamic, delivering rapid, non-abasive relief during acute flares. Because we can leverage our existing commercial infrastructure and overlapping targeted prescribers, this program could represent a high-margin growth driver built entirely on top of our NEPI foundation. We look forward to updating you in the future on this exciting program. In closing, our strategic priorities for the next phase of ARS are established and the baseline for how we operate will be defined by discipline, provider targeted, commercial strategy, and strong financial stewardship. We believe that doing this well yields a profitable company built on durable, recurring NFE franchise with additional upside driven by our CSU program. That is the business we're out to build and why I'm excited about our future.

I look forward to updating you on our progress in the quarters ahead. With that, we'll now open the line for questions.

Operator

Thank you. Thank you. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. stand by while we compile the Q&A roster. And our first question comes from Josh Schwimmer of Cantor Fitzgerald. Your line is open.

分析師問答

Joshua Schimmer

Thanks for taking the questions and for articulating your views on the outlook for the franchise, Don. A couple of quick questions. Maybe you can discuss both the gross to net in the quarter, how that's been evolving, as well as the product margins and the cost of goods that look like those ticked up this quarter and what might be the future. of drove that and what you envision going forward. And then for the field-targeted accounts, maybe you can talk a little bit about what you think the company can do going forward to really get that 8% penetration up substantially higher. Thank you.

Donn Casale

Hey Josh, hey thanks for your questions. So I'll start with both gross to net and gross margin. I'll have maybe Kathy add a bit more color to that. But as it relates to gross to net, We anticipate kind of ebb and flow as it relates to gross to net, depending on the mix of different various segments, each core, but that being said, we're comfortable in the range of 50% or approaching 50%. Importantly though, when we look ahead in some of the forward looking guidance as it relates to cash flow breakeven, as well as NIFI franchise profitability. We're really fascinated satisfied and comfortable with the grossing net that we have currently. In regard to gross margin, Certainly, we anticipate that to continue to get more favorable over time.

But, Kath, do you mind maybe adding a little bit more color as it relates to kind of the growth margin?.

Kathleen Scott

Sure. Hi, Josh. So our gross margin was about, excuse me, 62% in Q2 and a little over 64% year-to-date. And that was lower than we project going forward for a few reasons. One is the establishment of some reserves for short-dated product, some manufacturing inefficiencies as we continue to scale production, and costs for the ex-US product launches. So we do expect our gross margin to improve over time and really as we get into 2027 as we streamline and grow our manufacturing.

Donn Casale

Got it. Thank you. And then, Josh, regarding the 8 percent market share and certainly the increase from a year ago of 4 percent, You know, we're excited. One of the areas that we believe is going to continue to help support market share growth is we completed the expansion of our sales team. It's fully deployed, and so we have an opportunity to leverage that moving forward into Q3. That is something that we're very excited about. Ultimately, at the end of the day, we know when we send in our field team, we can increase market share. So that coupled with, we'll continue to evolve our messaging campaign. We think there's an opportunity to continue to engage not only the physician, but the nurses and the MAs to really get them to stop about the consequences of inaction.

And so our messaging campaign will continue to evolve. But ultimately, it's blocking and tackling execution, providing provider by provider in these types of entrenched markets, which we believe will continue to drive market share, which ultimately underpins our confidence around NEPI profitability.

Joshua Schimmer

Thanks very much. Good luck. Thank you, Josh. Thank you. Thank you.

Operator

And our next question comes from Ryan Deshner of Raymond James. Your line is open.

Ryan Deschner

Thanks for the question. Two for me. The first, how are you thinking about the progression of payer access going forward and how critical to your new strategy is getting on Caremark's formulary in the next cycle? And then regarding DTC, can you give us a little more color on what specifically the new sort of strategy for DTC will look like going forward in terms of channels, media, and spend, and how this will be different from the previous strategy?.

Donn Casale

Sure, thanks Ryan for the question. So first with access, we'll continue to engage and work towards reducing friction. access is important. It is a key first step. But we believe the second step around provider conviction and ensuring that they have essentially the reason to change and working with providers to change is going to be critical as we move forward. So there's coverage currently, 90 percent commercial coverage, 57% without a prior authorization. But with that, we do believe, again, we're going to have to continue to work on provider conviction because our strategy has shifted from consumer and activating the consumer to really activating the provider, which allows us to be much more efficient in our model. And we believe there's a recurring opportunity moving forward with that.

As it relates to DTC, obviously when we launched, we had significant DTC, which is linear TV, closed circuit TV. It drove a lot of awareness in the marketplace, and that awareness still exists today. As we look ahead, we're looking towards more efficient consumer campaigns and media spend. That's going to be around traditional channels such as social media, search, those types of channels, which we believe are much more efficient. We use those same channels, quite frankly, for providers as well, which allows us to be more targeted, given the provider universe. but there's a pretty significant shift away from this broad-based DTC, which has enabled to be much more efficient on our SG&A, which we reported today. Thank you very much. Thank you, Ryan.

Operator

And our next question comes from Marana Ruiz of Learing Partners. Your line is open.

Unknown Speaker

Hi, everyone. A couple of questions from me. First, could you talk about the path to cash flow break even into 2027? elaborate on what assumptions are baked into that goal? And are you also considering things like the back to school potential tailwind for NEFI next year?.

Donn Casale

Sure, regarding the cash flow break-even comment, we're comfortable certainly with that statement. a big part of that is being driven around our spend and be more efficient on our spend. As we shared, our SG&A was reduced by over 40% from the first semester to the second semester. And importantly, that trend continues throughout all 2027. So we have a much more efficient, effective spend on SG&A, so that's certainly a big underpinning of that confidence around breakeven. Also, as we look at revenue, as I said earlier, around growth to net and some of our other assumptions, we feel very comfortable in continued revenue gains and market share gains quarter over quarter, year over year, which will also underpin our path to profitability and cash flow break even moving forward. Got it. And a quick- Back to school. On back to school, it's, you know, obviously Q3 is the busiest quarter.

The strategy stays the same. It's around engaging providers and driving awareness and conviction for change. with those providers. Q3 just offers more volume relative to the other quarters as we all know. So our strategy will stay the same and so obviously we anticipate more prescriptions in Q3 relative to other quarters because of back to school.

Unknown Speaker

Makes sense. And a quick follow-up. I also wanted to ask, you seem to be talking about meaningfully changing provider prescribing habits and that kind of your overarching strategy going forward. Can you elaborate a bit more like what particular habits that you want to break, any sort of education or detailing that you're.

Donn Casale

New- The break is this entrenched behavior for decades long of using auto injectors, and that takes time. in these prevention types of markets where providers are doing the same thing over and We believe high-level frequency with the right message at the right time will break those habits. Our job, quite frankly, is to get our providers to stop and think about the problem that's in front of them. Once there's an appreciation around the problem, the solution becomes obvious. And that's really the strategy. So when we talk about the habit of a provider, the fact is they're writing the same thing and not thinking about consequences of that action. And that's where the field team comes in to really tell the story and sell the story on the value proposition of NEFI, as well as the problem that NEFI solves for. So that takes time. And that's why when we think about, you know, looking forward, we believe there's a very methodical increase quarter over quarter of both revenue and share gains, and it's going to be provider by provider. But we're really excited about the fact that we have the full team in place.

Execution and fundamentals is what's going to be what changes this. Makes sense. Thanks. Thanks, Rowena. Thank you. Thank you.

Operator

And our next question comes from Lachlan Hanbury-Brown of William Blair. Your line is open.

Lachlan Hanbury-Brown

Yes, hey, thanks for taking the questions. So, Don, you talked about sort of focusing on the prescriber engagement. the obvious outcome of that is sort of scripts and revenue. But I'm wondering if there are other metrics that you can look at in the interim. I mean, you've you sort of just said that, you know, It takes time, obviously, to change these behaviors and grow market share. So is there... Are there other metrics of prescriber engagement you can look at beyond just scripts that may help you evaluate how the current strategy is going?.

Donn Casale

Well, we'll certainly look at, you know, obviously the best indicator is Scripps and market share, and that's going to be an important metric. As I said earlier, we're going to share every quarter so you can track our progress from a year-over-year perspective. We're going to look at activity and where we look at frequency. So again, it's going to take multiple calls on not only the physician, but the nurse, the MA, the total office. So we'll look at the types of activities we do that seems to drive different types of behaviors and outcomes from a script perspective. But it is going to come down to, again, some of the basics around frequency, the right message with the right target. over time and so we'll continue to monitor that. But we have a blueprint and we certainly have seen where we deploy the team, we see significant changes in market share and as I said in the prepared remarks, 8% share in that total field targeted universe versus a 1% share where we don't send our team.

So that gives us a lot of confidence to continue with this strategy and focus on execution.

Lachlan Hanbury-Brown

Got it, thanks. And maybe the second one, I did see in the NQ that you ended into a license agreement in July for worldwide rights to certain IP. Anything you can say on that? I mean, is that a sort of potential pipeline expansion opportunity?.

Donn Casale

Yes, it's really kind of an opportunity for us to think about a line extension and give us some opportunities. for our pipeline. Too early right now to comment on it, but right now It's an opportunity for us to think about line extension for the franchise.

Operator

Thanks. Thank you. This concludes our question and answer session and also today's conference call. Thank you for participating and you may now disconnect.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]