ARSファーマシューティカルズ（SPRY）2026年第2四半期決算説明会：neffyのシェア拡大とコストリセット

主要なポイント

• ARSファーマシューティカルズが発表した2026年第2四半期売上高は3,370万ドルで、そのうち全米での「neffy」の製品売上高（純額）は2,620万ドルとなりました。
• neffyの全米市場における総合シェアは前年同期の2.5%から5%に拡大しました。対面営業のターゲットアカウントにおけるシェアは前年の4%から8%に上昇したのに対し、ターゲット外のアカウントでは約1%にとどまりました。
• 当四半期中にneffyを処方した医療従事者数は1万6,000人（重複除く）を超え、前年同期の3倍以上の水準となりました。
• 経営陣は、広範な消費者向け直接広告（DTC）から、市場全体の44%の機会を占める優良処方者への頻繁な働きかけへと商業投資の軸足を移しています。
• 2026年下半期の現金ベースの販売管理費（SG&A）および研究開発費（R&D）は、合計1億ドルから1億1,000万ドルとなる見込みです。経営陣は、見直されたコスト構造により、2027年末までにキャッシュフローの損益分岐点を達成する道筋が確保されたとしています。
• 慢性特発性じんま疹（CSU）を対象とした経鼻エピネフリンの第2b相中間結果の発表は、患者が3回の異なる発作エピソードを記録するのに時間を要することから、2027年第1四半期に延期される見込みです。

主要財務データ

事業および業績の動向

ARSファーマシューティカルズは、neffyの商業化戦略を広範な消費者へのアプローチから医療従事者中心の体制へと再編しています。経営陣は、アレルギー症状の発症前に処方および調剤が行われるため、エピネフリン救急市場は予防ベースのものであると説明しています。これにより、針式の自己注射器を中心とした長年の処方習慣を変更することに対する抵抗が生じています。

同社によると、現場でのアプローチが顕著な効果を上げています。営業チームが配置されていない地域でのシェアが約1%であったのに対し、ターゲットに設定された領域でのneffyのシェアは8%に達しました。ARSは営業組織の拡充を完了しており、今後は市場機会の44%を占める最も重要な処方者に焦点を当てていきます。

現在の商用保険のカバー率は90%に達しており、そのうち57%は事前承認なしで利用可能です。経営陣は、カバー率の拡大は依然として重要であるものの、処方に着実につながるためには、薬価収載（フォーミュラリー）へのアクセスと医療従事者の強い確信が不可欠であると説明しました。

ARSは、地上波テレビや閉鎖型テレビ広告などの広範なキャンペーンから撤退し、ソーシャルメディアや検索などのチャンネルを通じた、よりターゲットを絞った消費者向けアプローチを維持します。経営陣は、この手法により売上高の成長を維持しながら商業的効率を向上させることができると考えています。

同社はまた、医療従事者重視の戦略を維持しつつ、第3四半期の処方量が新学期（バック・トゥ・スクール）シーズンの特需による恩恵を受けると予想しています。

業績予想（ガイダンス）

ARSは、2026年下半期のSG&AおよびR&D費用の合計を1億1,400万ドルから1億2,600万ドルと予想しています。2026年上半期からの現金ベースのSG&Aの40%以上の削減により、現金ベースのSG&AおよびR&D費用は1億ドルから1億1,000万ドルとなる見込みです。

経営陣は、この支出抑制の傾向が2027年を通じて続くと見込んでいます。厳格な費用削減と、前四半期比および前年同期比での売上高と市場シェアの伸びを見込み、同社は2027年末までにキャッシュフローの損益分岐点を達成する道筋を描いています。

売上総利益率は、ARSが製造を効率化し生産規模を拡大するにつれて、特に2027年に向けて徐々に改善する見込みです。また経営陣は、市場シェアが急激に変化するのではなく、各四半期を通じて着実に拡大していくと予想しています。

リスクと注目点

• 自己注射器に対する医療従事者の数十年におよぶ依存傾向を変えるには、医師、看護師、医療助手に対して継続的な働きかけが必要になると予想されます。
• グロス・ツー・ネットの比率は、支払者および顧客セグメントの構成によって変動する可能性があります。
• 第2四半期の売上総利益率は、有効期限の近い製品の引当金、製造の非効率性、米国以外での製品ローンチに関連する費用によって圧迫されました。
• 商用保険のカバー率は広範であるものの、事前承認なしで利用できるのは57%にとどまり、一部の患者にとっては保険償還上の摩擦が残っています。
• 適切なデータ収集のために患者が3回の異なる発作エピソードを経験し記録する必要があるため、CSU第2b相の中間結果発表は2027年第1四半期に延期されました。

アナリストQ&Aの要点

経営陣は、ターゲットアカウントでの浸透率向上は、営業力の本格稼働、医療現場での継続的な対話、そして何もしないことによる不利益に焦点を当てた情報発信によって達成されるとしています。処方数と市場シェアが引き続き主要な業績評価指標となり、営業活動データや訪問頻度データがそれを補完します。

支払者によるアクセスに関して、ARSは民間保険およびメディケイド（公的医療保険）のカバー率拡大に引き続き取り組んでいきます。しかし経営陣は、アクセス確保は最初のステップに過ぎず、医療従事者の行動変容こそが新しい商業化戦略の中核であると強調しました。

収益性に関して、経営陣は2027年末までにキャッシュフローの損益分岐点を達成する目標について、主に販売管理費の削減とneffyの売上および市場シェアの継続的な成長に紐付けています。同社は、現在のグロス・ツー・ネットの前提条件がこの見通しに含まれていると述べました。

ARSはまた、7月に特定の知的財産権の全世界におけるライセンス契約を締結しました。経営陣はこれを製品ライン拡張の機会と説明しましたが、詳細を明らかにするのは時期尚早であるとしています。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.]