ARS Pharmaceuticals Inc (SPRY) 2025 Q2 法說會逐字稿

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

早安，歡迎參加 ARS Pharmaceuticals 電話會議。（操作員指示）請注意，今天的會議正在錄音。現在我將把電話轉給首席商務官賈斯汀·查克瑪 (Justin Chakma)。請繼續。

Good morning, and thank you for joining our second quarter 2025 earnings conference call. This morning, we issued a press release detailing our financial results and commercial highlights, which is available in the Investors & Media section of our website at ars-pharma.com.

早安，感謝您參加我們的 2025 年第二季財報電話會議。今天上午，我們發布了一份新聞稿，詳細介紹了我們的財務業績和商業亮點，您可以在我們網站 ars-pharma.com 的「投資者和媒體」部分找到。

With me on the call are Richard Lowenthal, our Co-Founder, President and CEO, who will review recent corporate updates and achievements. Eric Karas, our Chief Commercial Officer, who will cover our commercial activities and progress and Kathy Scott, our CFO, who will provide a summary of our financial results and cash position.

與我一起參加電話會議的還有我們的共同創辦人、總裁兼執行長理查德·洛文塔爾 (Richard Lowenthal)，他將回顧公司最近的動態和成就。我們的商務長 Eric Karas 將負責介紹我們的商業活動和進展，我們的財務長 Kathy Scott 將提供我們的財務表現和現金狀況摘要。

Before we begin, please note that today's remarks may contain forward-looking statements. Actual results may differ materially. Please refer to our earnings release and SEC filings for further risk disclosures.

在我們開始之前，請注意今天的評論可能包含前瞻性陳述。實際結果可能存在重大差異。請參閱我們的收益報告和美國證券交易委員會 (SEC) 文件以取得進一步的風險揭露。

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

說完這些，我會把電話轉給里奇。

Thank you, Justin. Good morning, everybody, and thank you for joining us to discuss our commercial momentum with Neffy in the second quarter of this year and early weeks of the third quarter. We have long believed that a needle-free portable and reliable epinephrine treatment option could transform how patients and providers treat severe allergies.

謝謝你，賈斯汀。大家早安，感謝大家加入我們，討論今年第二季和第三季初與 Neffy 的商業發展勢頭。我們一直相信，無針、便攜且可靠的腎上腺素治療方案可以改變患者和提供者治療嚴重過敏的方式。

The commercial data we will share today confirm that this vision is becoming a reality. Neffy is gaining traction across prescribers, payers, and patients, which we will talk about during this presentation. Our momentum is reflected in the continued quarter-over-quarter growth in the US net product revenue for Neffy.

我們今天將分享的商業數據證實這個願景正在成為現實。Neffy 正在獲得處方者、付款人和患者的青睞，我們將在本次演講中討論這一點。我們的勢頭體現在 Neffy 美國淨產品收入的持續環比增長。

In Q2, we achieved $12.8 million in net product revenue in part driven by the availability of our 1-milligram pediatric dose starting in May and steady traction we have made with payers. With 93% commercial coverage today, Neffy is accessible to the vast majority of patients with commercial insurance. Perhaps more importantly, this momentum has translated into strong and accelerating growth in Neffy prescriptions, a clear indicator of demand and commercial execution.

在第二季度，我們實現了 1,280 萬美元的淨產品收入，部分原因是從 5 月開始提供 1 毫克兒科劑量，以及我們與付款人的穩定聯繫。目前，Neffy 的商業覆蓋率已達 93%，絕大多數擁有商業保險的患者都可以使用。或許更重要的是，這種勢頭轉化為 Neffy 處方的強勁和加速成長，這是需求和商業執行的明顯指標。

From the end of the first quarter to the end of the second quarter of 2025, we saw an increase of 180% in weekly two-pack unit volume, which was in line with our internal expectations and consistent with analyst forecasts. This growth is particularly encouraging as it comes before we have realized the full effects of three key important drivers.

從 2025 年第一季末到第二季末，每週雙包裝單位銷售量成長了 180%，符合我們的內部預期，也與分析師的預測一致。這種成長尤其令人鼓舞，因為它發生在我們充分認識到三個關鍵重要驅動因素的影響之前。

First, the rollout of our national DTC campaign, which started with targeted advertising in early June and was followed by an expansion to linear TV in July.

首先，我們推出了全國性的 DTC 活動，該活動於 6 月初以定向廣告開始，隨後於 7 月擴展到線性電視。

Second, our US pediatric co-promotion with ALK which was fully deployed in late June.

第二，我們與ALK在美國兒科的共同推廣已於6月底全面展開。

And third, the peak prescribing season of late summer and early fall as parents and children head back to school. As such, we expect to see even greater growth in Neffy prescriptions in the third and fourth quarters of this year.

第三，夏末秋初是處方藥的高峰期，因為家長和孩子都回來了。因此，我們預計今年第三季和第四季 Neffy 處方量將出現更大的成長。

Beyond our US commercialization, our partners are executing well to establish Neffy as a global brand. In June, ALK successfully launched EURneffy in Germany, the first country outside the United States to have commercial access to intranasal epinephrine. In July, your Neffy was approved in the United Kingdom, which is the largest market outside the US for epinephrine auto-injector sales.

除了美國的商業化之外，我們的合作夥伴也在努力將 Neffy 打造為全球品牌。6 月，ALK 在德國成功推出 EURneffy，這是美國以外第一個實現鼻內腎上腺素商業化的國家。7 月份，Neffy 在英國獲得批准，英國是美國以外最大的腎上腺素自動注射器銷售市場。

Looking ahead, we expect additional regulatory decisions on Neffy in Canada, Australia and Japan by the end of 2025 and in China by the first half of 2026 followed by commercial rollout starting in the first half of next year.

展望未來，我們預計加拿大、澳洲和日本將在 2025 年底前對 Neffy 做出更多監管決定，中國將在 2026 年上半年前對 Neffy 做出更多監管決定，並於明年上半年開始進行商業推廣。

We also expect approval of the 1-milligram pediatric dose by the European Medical Agency in the first half of 2026, which would trigger another $5 million milestone payment from ALK. Beyond our first approved indication, we're expanding the reach of our intranasal epinephrine technology with the initiation of a randomized controlled Phase IIb clinical trial in chronic spontaneous urticaria, a life-altering condition that affects millions of people. This study is underway with sites in the US and Europe, and we anticipate top line data in the first half of 2026.

我們也預計歐洲醫療機構將在 2026 年上半年批准 1 毫克兒科劑量，這將觸發 ALK 再支付 500 萬美元的里程碑付款。除了我們第一個核准的適應症之外，我們還在擴大我們的鼻內腎上腺素技術的覆蓋範圍，啟動了針對慢性自發性蕁麻疹的隨機對照 IIb 期臨床試驗，慢性自發性蕁麻疹是一種影響數百萬人生活的疾病。這項研究正在美國和歐洲的站點進行，我們預計將在 2026 年上半年獲得頂線資料。

Let me now turn the call over to Eric to review our US commercial performance in more detail.

現在，讓我將電話轉給 Eric，讓他更詳細地回顧我們在美國的商業表現。

Thank you, Rich. Starting first with physician engagement and demand, our 118 person sales organization at ARS has now reached approximately 15,000 health care providers. More than 9,700 of them have a dispensed prescription for Neffy with over 70% coming from the highest three deciles of prescribers. These figures reinforce the strength of our physician targeting and engagement strategy.

謝謝你，里奇。從醫生的參與和需求開始，我們 ARS 的 118 人銷售組織現在已經涵蓋了大約 15,000 名醫療保健提供者。其中超過 9,700 人持有 Neffy 的處方，超過 70% 的處方來自處方量最高的三個十分之一的醫生。這些數字增強了我們的醫生定位和參與策略的力度。

The Neffy Experience program, which now includes the 1 milligram dose, has successfully enrolled over 200 allergists and approximately 20,000 doses of both the 1-milligram and 2-milligram Neffy have been distributed for use in offices during oral food challenges.

Neffy Experience 計劃目前包括 1 毫克劑量，已成功招募超過 200 名過敏症專科醫生，並且已分發了約 20,000 劑 1 毫克和 2 毫克 Neffy，供辦公室在口服食物挑戰期間使用。

With hundreds of uses already recorded, the real-world exposure is helping to build confidence in the effectiveness and safety of Neffy. We anticipate sharing more outcomes data from this program later in the year. Over 3,200 schools have joined our neffy in Schools program, establishing Neffy as a preferred epinephrine treatment in educational settings.

由於已經記錄了數百種用途，現實世界的暴露有助於增強人們對 Neffy 的有效性和安全性的信心。我們預計將在今年稍後分享該計劃的更多成果數據。超過 3,200 所學校加入了我們的「學校 neffy」計劃，使 Neffy 成為教育環境中首選的腎上腺素治療方法。

With the 1 milligram pediatric dose availability, participating schools can now carry both 1-milligram and 2-milligram doses for emergency use. Since the end of first quarter, 14 states have updated their legislation to allow designated school employees to administer our needle-free epinephrine emergencies. This change reflects the strong demand for neffy. The advocacy for neffy was also clearly expressed at the National Association of School Nurses conference that ARS attended in June.

由於有 1 毫克兒科劑量，參與學校現在可以攜帶 1 毫克和 2 毫克劑量以備緊急情況使用。自第一季末以來，已有 14 個州更新了立法，允許指定的學校員工管理我們的無針腎上腺素緊急情況。這一變化反映了對 neffy 的強烈需求。ARS 在 6 月參加的全國學校護士協會會議上也明確表達了對 neffy 的倡導。

On the payer front, we have reached a critical inflection point with 93% commercial coverage, including in scenarios where prior authorization is submitted. Approximately 57% of commercial payers do not require PAs for patients to fill neffy. For those payers that do require a PA, health care professionals can now manage the process more easily. The prior authorization approval rates for neffy with payers under the major PBMs closely aligned with the access levels in the overall commercial epinephrine market.

在付款人方面，我們已經達到了一個關鍵的轉折點，商業覆蓋率達到 93%，包括提交事先授權的情況。大約 57% 的商業付款人不需要病患 PA 來填寫 neffy。對於確實需要 PA 的付款人，醫療保健專業人員現在可以更輕鬆地管理該流程。主要 PBM 下的付款人對 neffy 的事先授權批准率與整個商業腎上腺素市場的准入水平密切相關。

For example, payers under Zinc Health Services, the group purchasing organization for CVS Caremark account for approximately 30% of neffy dispenses, in line with the overall epinephrine market. This is despite more than three quarters of CVS Caremark members still requiring PAs. It's encouraging to note that these PAs are being approved more than 80% of the time. For patients with commercial insurance, our co-pay assistance program ensures that most individuals only pay $25, which is significantly less than the average $40 for a generic injector.

例如，CVS Caremark 的集團採購組織 Zinc Health Services 旗下的付款人佔 neffy 配藥量的約 30%，與整體腎上腺素市場一致。儘管超過四分之三的 CVS Caremark 會員仍然需要 PA。令人鼓舞的是，這些 PA 的批准率超過 80%。對於擁有商業保險的患者，我們的共同支付援助計劃確保大多數個人僅支付 25 美元，這遠低於通用注射器的平均 40 美元。

Additionally, co-pay support is now automatically applied at the point of sale in 95% of pharmacies, including all of the major retail pharmacies and grocery store chains, such as CVS, Walgreens, Walmart, Rite Aid, Costco, Kroger and Publix.

此外，95% 的藥局（包括所有主要零售藥局和連鎖雜貨店，如 CVS、Walgreens、沃爾瑪、Rite Aid、Costco、Kroger 和 Publix）現在都會在銷售點自動應用共同支付支援。

With increasing fill rates, this program ensures that patients can access neffy when they need it the most. Together, these changes represent a meaningful shift for our early launch phase. Broader coverage and streamlined prescribing are enabling a more confident and seamless experience for HCPs.

隨著填充率的提高，該計劃確保患者在最需要的時候能夠獲得 neffy。總的來說，這些變化代表著我們早期發布階段的一個有意義的轉變。更廣泛的覆蓋範圍和簡化的處方為 HCP 帶來了更自信、更無縫的體驗。

As net volume increases in the coming months, we expect additional PBMs to remove PA requirements and adopt contracts that recognize the value of neffy at terms that are consistent with our 50% long-term gross to net retention guidance. This will further eliminate potential barriers to access for patients.

隨著未來幾個月淨交易量的增加，我們預計會有更多 PBM 取消 PA 要求，並採用符合我們 50% 長期毛利佔淨留存率指導的、承認 neffy 價值的合約。這將進一步消除患者就醫的潛在障礙。

Turning to consumer engagement. Our direct-to-consumer campaign, hello neffy, Goodbye Needles is gaining traction. The campaign launched in phases, connected TV and streaming platforms began in late May and early June followed by broadcast and linear television in July. We've since expanded both the reach and frequency on Linear TV to further increase branded awareness, encourage patients to ask for neffy by name. Since the campaign began in late Q2, aided awareness has increased significantly.

轉向消費者參與。我們的直接面向消費者的活動「你好 neffy，再見 Needles」正在獲得關注。該活動分階段啟動，連網電視和串流媒體平台於 5 月底和 6 月初啟動，隨後廣播和線性電視於 7 月啟動。從那時起，我們擴大了線性電視的覆蓋範圍和頻率，以進一步提高品牌知名度，鼓勵患者指名詢問 neffy。自第二季末啟動活動以來，輔助意識已顯著提高。

In the second half of July, Cantor, a market research firm conducted patient and caregiver surveys. The results show that nearly 50% of respondents recognized and recalled our DTC advertisement for neffy, which is higher than the cancer norms across approximately 150 other DTC campaigns.

7月下半月，市場研究公司Cantor對患者和照護者進行了調查。結果顯示，近 50% 的受訪者認識並回憶起我們為 neffy 製作的 DTC 廣告，這一數字高於約 150 個其他 DTC 活動的抗癌標準。

The branding for the neffy ad was also notably strong, with half of the response stating that they could not help but remember that it was for neffy, this also exceeded center norms. As awareness grows, we expect a continued increase in demand for neffy over time. Historically, DTC campaigns for pharmaceuticals start to show an impact about 12 to 16 weeks after they begin. Additionally, we know that the average consumer needs to see an ad about seven to eight times before they take action. We are confident in the feedback we've received and the expected broader impact of our DTC campaign.

neffy 廣告的品牌效果也非常強，一半的受訪者表示，他們不禁記得這是 neffy 的廣告，也超越了中心規範。隨著人們認識的不斷提高，我們預計對 neffy 的需求將隨著時間的推移持續增加。從歷史上看，藥品的 DTC 活動在開始後約 12 至 16 週開始顯現影響。此外，我們知道，一般消費者需要看七到八次廣告才會採取行動。我們對收到的回饋以及 DTC 活動預期的更廣泛影響充滿信心。

Lastly, we are pleased with the positive growth trajectory in the volume of neffy prescriptions. Feedback from our sales organization indicates increased adoption across all patient segments. This includes patients switching from auto injectors, those with elapsed Rx and are returning to therapy and new patients being prescribed epinephrine for the first time.

最後，我們對 neffy 處方量的正向成長軌跡感到滿意。我們的銷售組織的回饋表明，所有患者群體的採用率都有所增加。這包括從自動注射器轉換過來的患者、處方已過期並重新接受治療的患者以及首次被處方腎上腺素的新患者。

This broad-based adoption highlights the pill of neffy as a preferred treatment in the epinephrine market. The combination of our field execution, increased consumer awareness and demand and a smoother prescribing experience for health care professionals, has established a strong foundation for continued commercial growth.

這種廣泛的採用凸顯了 Neffy 藥丸作為腎上腺素市場上的首選治療藥物。我們的現場執行、不斷增強的消費者意識和需求以及為醫療保健專業人員提供更順暢的處方體驗，為持續的商業成長奠定了堅實的基礎。

I'm proud of what the team has accomplished so far and look forward to sharing more about our progress in the second half of the year.

我為團隊迄今為止的成就感到自豪，並期待在今年下半年分享更多我們的進展。

I'll now pass the call over to Kathy to walk through our financials.

我現在將電話轉給凱西，讓她介紹我們的財務狀況。

Thank you, Eric. We continue to maintain a strong cash position while investing significantly in the commercial growth of neffy. Starting with our revenue for the second quarter of 2025, we recorded total revenue of $15.7 million. As we go forward, it's important that we look at revenue in terms of product revenue from our core US commercial efforts and then collaboration and supply revenue separately.

謝謝你，埃里克。我們繼續保持強勁的現金狀況，同時對 neffy 的商業成長進行大量投資。從 2025 年第二季的收入開始，我們的總收入為 1570 萬美元。隨著我們不斷前進，重要的是我們要從來自我們核心美國商業努力的產品收入以及合作和供應收入的角度來看待收入。

That distinction is key as US net product revenue reflects underlying demand and loss penetration with neffy. The milestone and supply revenues, while important for our overall financial performance, represent onetime or partnership-related income streams.

這種區別至關重要，因為美國淨產品收入反映了潛在需求和 neffy 的損失滲透率。里程碑和供應收入雖然對我們的整體財務表現很重要，但它們代表一次性或與合作相關的收入來源。

Our US net product revenue for neffy in Q2 was $12.8 million, reflecting a 64% increase compared to net product revenue in the first quarter of the year. We expect to see continued growth in product revenue as we start to recognize the impact of our DTC campaign as well as the prescription growth and improved payer access environment that Eric described.

我們第二季 neffy 在美國的淨產品收入為 1,280 萬美元，與今年第一季的淨產品收入相比成長了 64%。隨著我們開始認識到 DTC 活動的影響以及 Eric 所描述的處方增長和付款人訪問環境的改善，我們預計產品收入將繼續增長。

In terms of collaboration revenue, a $5 million milestone payment from ALK was triggered related to the launch of EURneffy in Germany in June, and we generated an additional $0.3 million in supply revenue from our partners. Of the $5 million milestone, we recognized $2.6 million of revenue and the remaining $2.4 million was recorded through the financing liability on the company's balance sheet in accordance with the GAAP accounting treatment of our original licensing agreement with ALK.

在合作收入方面，ALK 於 6 月在德國推出 EURneffy 時支付了 500 萬美元的里程碑付款，此外我們還從合作夥伴那裡獲得了 30 萬美元的額外供應收入。在 500 萬美元的里程碑中，我們確認了 260 萬美元的收入，其餘 240 萬美元則根據我們與 ALK 的原始許可協議的 GAAP 會計處理，透過公司資產負債表上的融資負債記錄。

With regard to the EURneffy 1 milligram dose in the EU, we anticipate EMA approval in the first half of 2026, which would trigger an additional $5 million milestone payments from ALK. Similarly, approximately half of that $5 million would be recognized as GAAP revenue in the first quarter of 2026, and the other half would be added to the financing liability on the balance sheet.

對於歐盟的 EURneffy 1 毫克劑量，我們預計 EMA 將在 2026 年上半年批准，這將觸發 ALK 額外支付 500 萬美元的里程碑付款。同樣，這 500 萬美元中約有一半將在 2026 年第一季確認為 GAAP 收入，另一半將添加到資產負債表的融資負債中。

Turning to our operating expenses. R&D expenses for the second quarter were $4 million, primarily related to the initiation of our Phase IIb urticaria trial and continued clinical and development expenses for neffy. SG&A expenses were $54.3 million, reflecting our investment in a strong national DTC campaign and continued sales and marketing efforts for neffy.

談到我們的營運費用。第二季的研發費用為 400 萬美元，主要用於啟動我們的 IIb 期蕁麻疹試驗以及持續的 neffy 臨床和開發費用。銷售、一般及行政費用為 5,430 萬美元，反映了我們對強大的全國 DTC 活動的投資以及對 neffy 持續的銷售和行銷努力。

We remain committed to making substantial investments in the launch of neffy to ensure both short- and long-term patient and physician awareness and market share capture. As a reminder, for modeling purposes, the bulk of our DTC campaign investment of approximately $50 million will be recognized in our SG&A expenses in the second and third quarters of this year.

我們將繼續致力於對 neffy 的推出進行大量投資，以確保短期和長期患者和醫生的認知度和市場份額。提醒一下，出於建模目的，我們的 DTC 活動投資約 5,000 萬美元，其中大部分將在今年第二季和第三季計入銷售、一般及行政費用 (SG&A)。

Lastly, cost of goods sold increased from the first quarter due to higher product sales and also establishing a onetime inventory reserve for older inventory. This is not expected to recur and COGS for neffy remains highly favorable. Another favorable aspect to our financials this quarter is the update on our gross to net retention. As payer coverage has improved, the trend in our gross to net yields has progressed as we anticipated. Our GTN retention moved from about 70% in the fourth quarter of 2024 to the mid-60% range in the first quarter of 2025 and now to the low 50% range in Q2.

最後，由於產品銷售增加以及為舊庫存建立一次性庫存儲備，銷售成本較第一季增加。預計這種情況不會再次發生，並且 neffy 的 COGS 仍然非常有利。本季我們財務狀況的另一個有利方面是我們的毛留存率與淨留存率的更新。隨著付款人覆蓋率的提高，我們的總收益與淨收益的趨勢已如我們預期的那樣發展。我們的 GTN 保留率從 2024 年第四季的約 70% 上升至 2025 年第一季的 60% 左右，現在又上升至第二季的 50% 以下。

This progression reflects the success of our payer access strategy with an increasing volume of medications now covered without prior authorization and therefore, eligible for rebate payments under our payer contracts. We have previously guided to a steady state gross to net retention of approximately 50%, which we reached in the second quarter. Looking ahead, we expect our gross to net retention to be maintained around this level providing greater predictability in future revenue modeling.

這一進展反映了我們的付款人准入策略的成功，現在越來越多的藥物無需事先授權即可獲得覆蓋，因此有資格根據我們的付款人合約獲得退款。我們之前曾預期總留存率與淨留存率將穩定在 50% 左右，並且已在第二季達到此目標。展望未來，我們預期總留存率與淨留存率將維持在這一水準附近，從而為未來的收入模型提供更大的可預測性。

Lastly, on our cash position, maintaining a strong balance sheet with over three years of operating runway, remains foundational to our corporate strategy. enabling us to advance our commercial efforts with focus and stability.

最後，就我們的現金狀況而言，保持強勁的資產負債表和超過三年的營運跑道仍然是我們公司策略的基礎，使我們能夠專注、穩定地推進我們的商業努力。

We ended the second quarter of 2025 to cash, cash equivalents and short-term investments of $240.1 million. This balance sheet strength means we are well positioned to fully capitalize on the US commercial opportunity for neffy, while maintaining financial discipline and resilience and dynamic market environment.

截至 2025 年第二季度，我們的現金、現金等價物和短期投資為 2.401 億美元。這種資產負債表實力意味著我們完全有能力為 neffy 充分利用美國的商業機會，同時保持財務紀律和彈性以及動態的市場環境。

With that, I'll pass the call back over to Rich.

說完這些，我就把電話轉回給里奇。

Thank you, Kathy. As we move into the second half of 2025, we remain focused on our top priorities. First, sustaining and accelerating market share growth through the peak back-to-school season, driven by our DTC investment in the coming weeks and months.

謝謝你，凱西。隨著我們進入 2025 年下半年，我們仍將專注於我們的首要任務。首先，在未來幾週和幾個月的 DTC 投資推動下，在返校旺季維持並加速市場份額的成長。

Second, enabling neffy’ s global expansion through the international launches across our partner network, including in the UK later this year; and finally, advancing our urticaria program towards a potential label expansion.

其次，透過我們合作夥伴網路的國際發布，包括今年稍後在英國的發布，實現 neffy 的全球擴張；最後，推進我們的蕁麻疹計劃，實現潛在的標籤擴展。

We are fundamentally changing the treatment of Type I allergies, the barriers that kept patients from carrying and using epinephrine before, including the fear of needles, device complexity, portability and shelf life concerns are gone with neffy, and its delivery is easy for both patients and caregivers. Backed by neffy’ s growing awareness and adoption in the United States, expanding global reach and our advancing pipeline.

我們從根本上改變了 I 型過敏的治療方法，以前阻礙患者攜帶和使用腎上腺素的障礙，包括對針頭的恐懼、設備的複雜性、便攜性和保質期問題，隨著 neffy 的出現而消失，患者和護理人員都可以輕鬆地使用 neffy。在 neffy 在美國知名度和採用率不斷提高的支持下，其全球影響力不斷擴大，我們的產品線也在不斷改進。

I believe we're well positioned to deliver both near- and long-term value for our stakeholders and improve outcomes for patients worldwide. Thank you for your continued support.

我相信我們有能力為我們的利害關係人提供短期和長期價值，並改善全球患者的治療效果。感謝您一直以來的支持。

Operator, please open the line for questions.

接線員，請打開熱線以回答問題。

(Operator Instructions) Lachlan Hanbury-Brown, William Blair.

（操作員指示）Lachlan Hanbury-Brown，William Blair。

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

恭喜你取得進展。第一個問題是，您能否確認本季註銷或出貨的處方數量？其次，聽起來您看到 DTC 在認知度方面取得了令人鼓舞的進展。想知道是否有任何早期跡象表明這正在轉化為醫生關係要求的實際處方行為或類似行為？

Yes, Lachlan. Rich Lowenthal. So yes, I mean, with regards to number of prescriptions, you can calculate it. It's -- we have $12.8 million in net sales and gross net was roughly 52%. So it's about 35,000 prescriptions in the quarter, packs to packs, I should say. Some prescriptions are for two or three, two packs, but 35,000 two packs and then that compares to 19,000 in the first quarter.

是的，拉克蘭。里奇·洛文塔爾。是的，我的意思是，關於處方數量，你可以計算一下。我們的淨銷售額為 1,280 萬美元，毛淨額約為 52%。所以我應該說，本季的處方量大約是 35,000 張，一包一包的。有些處方是兩包或三包，但兩包的處方為 35,000 份，而第一季為 19,000 份。

And with regards to the DTC campaign, so really the linear TV, which tends to give the greatest impact on sales start at beginning of July. And normally, the norm in the industry is 12 to 16 weeks to start seeing significant impact from that return on investment. But we are getting a lot of feedback, certainly a lot of people -- even just people that are trying to find the case or are mentioning the ads, the DTC campaign and seeing the neffy carry case in the ad and they want to know how to get it. So we get a lot of feedback like that people are definitely seeing the ad, they're definitely acting on it.

就 DTC 活動而言，線性電視通常會在 7 月初開始對銷售產生最大影響。通常情況下，行業標準是 12 到 16 週後才能開始看到投資回報的顯著影響。但我們收到了很多回饋，當然有很多人——甚至只是那些試圖找到這個手機殼或提到廣告、DTC 活動並在廣告中看到 neffy 手提箱的人，他們想知道如何獲得它。因此，我們收到了很多回饋，例如人們肯定看到了廣告，他們肯定採取了行動。

And again, it takes a few months to get an appointment if you're a naive patient, maybe you have an appointment scheduled, but we're hoping that starts to translate to significant uptick in the near future. But that we would expect it to take 12 to 16 months to start seeing significant impact.

再說一次，如果你是一個初次就診的患者，可能需要等待幾個月才能預約，也許你已經安排好了預約，但我們希望在不久的將來這能帶來顯著的增長。但我們預計需要 12 到 16 個月才能開始看到顯著的影響。

Got it. And also, I think, Eric, you mentioned that you've seen some patients who previously lapsed prescriptions coming back in and filling prescriptions of neffy. Can you give a sense of how much -- like is that a sort of one-off patient doing that? Or are you seeing sort of consistent trend there?

知道了。而且，艾瑞克，我想你提到過，你看到一些之前處方失效的病人又回來拿 Neffy 的處方了。您能否說明一下－這是一次性病人做的那種手術嗎？或者您看到那裡存在某種一致的趨勢？

Yes, I can take this one. So it's still very early to kind of break all the data out. We do plan on doing a pretty extensive claims analysis in the fourth quarter end of the year. But the feedback that we're hearing, and I interact quite a bit with our field team and physicians is it really is a mix of patients that are switching.

是的，我可以接受這個。因此，現在公佈所有數據還為時過早。我們確實計劃在今年第四季末進行相當廣泛的索賠分析。但我們聽到的回饋以及我與現場團隊和醫生的大量互動表明，轉換的患者確實是多種多樣的。

Those are -- those patients that are also reengaged because now they have an option that is needle-free, easy to carry and obviously less evasive, but we're also getting patients that to your point, that are lapsed that really opted out because of the needle. So we see that kind of across the board and feedback from all physicians and kind of what we're seeing from our field feedback as well.

這些患者也重新接受了治療，因為現在他們有了無需針頭、易於攜帶且顯然侵入性更低的選擇，但我們也接收了您所說的那些因為針頭而真正選擇放棄治療的患者。因此，我們看到了來自所有醫生的全面回饋，以及我們從現場回饋中看到的回饋。

Roanna Ruiz, Leerink.

Roanna Ruiz，Leerink。

Maybe on to Lowenthal. Just one for me. So congratulations on the remarkable progress in commercial coverage. Just one on that. So the CVS Caremark is acquiring prior for some payers under sync. What's the realistic ceiling for coverage without prior authorization? And would you be able to quantify the revenue impact of moving that remaining zinc portion over the four quarters?

也許可以去洛文塔爾。對我來說只有一個。祝賀商業覆蓋方面取得的顯著進展。僅此一點。因此，CVS Caremark 正在同步收購一些付款人的優先權。未經事先授權的承保範圍的實際上限是多少？您能否量化在四個季度內轉移剩餘鋅部分對收入的影響？

Yes. I'm not sure -- sorry, Ruiz, I'm not sure exactly what you're asking with regards to the ceiling.

是的。我不確定——抱歉，魯伊斯，我不確定你關於天花板到底想問什麼。

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

從商業覆蓋率來看，上限是93%，您認為93%是高峰嗎？還是您認為仍有成長空間？

Yes. So hopefully, I'm answering your question correctly. But -- so about 25% of the CVS companies under CVS -- their Caremark are covering neffy without prior authorization, right? And then the rest are requiring a prior authorization, but there are no companies within the zinc network that are blocking neffy, so require any kind of medical exception. What's happening is, as we're getting better and better coverage without prior authorizations, it frees up doctors to write those prior authorizations for those companies that are still remaining.

是的。所以希望我能正確回答你的問題。但是——CVS 旗下大約 25% 的公司——他們的 Caremark 在未經事先授權的情況下就為 neffy 提供保險，對嗎？其餘的都需要事先授權，但鋅網絡內沒有任何公司阻止 neffy，因此需要任何類型的醫療例外。現在的情況是，隨著我們獲得越來越好的無需事先授權的保險，醫生就可以為那些仍然存在的公司寫事先授權。

So we haven't really seen any signs of a ceiling. The prior authorizations are staying fairly steady, but they're concentrating towards the companies that are not covering without prior authorization yet they don't have it on open access. So that's where we're at, at the moment. But I'm not sure if that answers your question exactly or not, but hopefully.

所以我們實際上還沒有看到任何天花板的跡象。事先授權保持相當穩定，但他們集中在那些未經事先授權但尚未開放獲取的公司。這就是我們目前的狀況。但我不確定這是否準確回答了你的問題，但我希望如此。

No. Actually, that's exactly I mean.

不。事實上，這正是我的意思。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

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

大家，恭喜本季取得佳績。我會盡量在這裡只問一個問題。因此，我們看到每週劇本的強勁成長，您認為在眾多因素中，哪一個因素將推動下半年的轉折點，然後可能會推動後續發展。

Well, certainly, the DTC campaign, Andreas is going to be a major driver. We also as we mentioned in our talk expanded the sales force with the partnership with ALK. So they're focused on the pediatricians, the ones that are prescribing. We think that will help dramatically. I mean it's adding 10% reach to our current market force, about 55% overall.

嗯，當然，在 DTC 活動中，安德烈亞斯將成為主要推動者。正如我們在談話中提到的那樣，我們還透過與 ALK 的合作擴大了銷售隊伍。因此，他們重點關注的是開處方的兒科醫生。我們認為這將會有很大幫助。我的意思是，它為我們目前的市場力量增加了 10%，整體增加了約 55%。

So we think those are really the major drivers. I mean, seasonality, we mentioned, but that's kind of routine and that's going to happen regardless. I mean, there's just an increase in the overall number of scripts over the summertime. But really, what we think are the big drivers of the DTC campaign to start raising awareness, not only among patients and caregivers, but among physicians too. So even the physicians that we don't reach, hopefully, we'll see these ads and realize there is a new product and research it.

因此我們認為這些才是真正的主要驅動因素。我的意思是，我們提到過季節性，但這是一種常規，無論如何都會發生。我的意思是，夏季劇本的總數增加。但實際上，我們認為 DTC 活動的主要驅動力是開始提高人們的意識，不僅是在患者和照護者中，而且在醫生中。因此，即使是那些我們無法聯繫到的醫生，我們也希望他們能看到這些廣告，意識到有新產品並對其進行研究。

And then obviously, that sales force expansion and we'll continue to evaluate things as we go forward as to what else we can do, given our cash position, we have a lot of flexibility, and we'll continue to evaluate things as we go forward.

然後顯然，銷售隊伍擴張，我們將繼續評估未來還能做些什麼，考慮到我們的現金狀況，我們有很大靈活性，我們將繼續評估未來還能做些什麼。

All right. And then just can you -- along the lines of the DTC, can you remind us how long you plan to have the campaigning last? And then just one more on back-to-school. How are you seeing the impact on scripts from the back-to-school season? And any thinking and along the same line, any thoughts around patients getting multiple packs in these type of back-to-school period for the year as they kind of given the ease of use and the multiple areas that the car, the house, et cetera. Any thoughts around that?

好的。然後，您能否—按照 DTC 的思路，提醒我們您計劃競選活動持續多久？然後再談一個關於開學的事。您如何看待開學季對劇本的影響？並且任何想法以及沿著同樣的思路，任何關於患者在一年中的這種返校期間獲得多個包裝的想法，因為它們考慮到了易用性和汽車，房屋等多個區域。對此有什麼想法嗎？

Yes. So with the DTC campaign, first of all, we're budgeted. We're actually looking at possibly even adding more to the budget for this year, and then we're budgeted for next year. So we anticipate that continuing at a similar pace, with the exception of some seasonality around holidays and things we may slow down, but certainly at a similar pace to what you're seeing now, and we would continue that through '26. And again, we're continually assessing that.

是的。因此，對於 DTC 活動，首先，我們有預算。實際上，我們正​​在考慮增加今年的預算，然後再製定明年的預算。因此，我們預計這一速度將持續下去，除了假期和一些季節性因素可能會放緩之外，但肯定與您現在看到的速度相似，而且我們將持續到 26 年。並且，我們正在不斷評估這一點。

And as we start seeing impact and we get data back on the effectiveness of our DTC campaign. We have some very good companies that we use to collect data on that. We'll obviously concentrate our efforts in those channels that are most effective and then also potentially increase the budget overall. But we do want to do that assessment over time and it's pretty typical at this stage.

當我們開始看到影響並得到有關我們的 DTC 活動有效性的數據時。我們有一些非常優秀的公司來收集這方面的數據。我們顯然會集中精力在最有效的管道上，然後也有可能增加整體預算。但我們確實希望隨著時間的推移進行評估，這在現階段非常典型。

And then sorry, what is your -- the multiple packs. We are seeing a lot of orders coming in for two or three packs of neffy, two packs. And certainly, with the case ordering as well, we're seeing a lot of people asking for two or three cases. And that, we think, is a good sign that people are looking to get multiple packs of neffy. But I don't know, Eric, if we have any statistics on that or we're just still at the early stage of that.

那麼抱歉，您的——多個包是什麼。我們看到很多訂單都是買兩包或三包 neffy，兩包。當然，隨著案件的訂購，我們看到很多人要求兩到三個案件。我們認為，這是一個好兆頭，表明人們希望購買多包 neffy。但是埃里克，我不知道我們是否有這方面的統計數據，或者我們仍然處於早期階段。

And also, one other thing, Andreas, as we've talked about in the past, a lot of people who are in a cash-based situation would buy a pack very easily. But then once they get insurance coverage or they meet their deductibles, they seem to be coming back to get more packs. But Eric, do you have anything to add to that?

另外，安德烈亞斯，還有一件事，正如我們過去談到的，許多有現金的人會很容易買一包。但一旦他們獲得保險或滿足免賠額，他們似乎又會回來購買更多套餐。但是艾瑞克，你還有什麼要補充的嗎？

Yes. Andres, we like track kind of these numbers, and I can tell you that what we're seeing in terms of number of cartons devices per patient for that initial prescription is slightly higher than what we've seen previously in the market. So these are things that we continue to drive our field teams to the points you made, especially with kids. Parents want the kids to have one with them at all times. They want to have one in the house, just in case.

是的。安德烈斯，我們喜歡追蹤這些數字，我可以告訴你，我們看到的初始處方中每個患者的紙盒設備數量略高於我們之前在市場上看到的數量。因此，我們會繼續督促我們的實地團隊實現您所提出的觀點，特別是針對孩子。父母都希望孩子能時時刻刻有它陪伴。他們想在家裡放一個，以防萬一。

So as Rich said, we are seeing multiple paths. It's messaging that we'll continue to drive. And there's a lot of programs, too, that we're doing through neffyConnect, but also even at the point of purchase, if a patient goes in and is covered. One thing that we updated a few months back was that we'll just charge on co-pay to $25 for multiple cartons. So again, we see this as an opportunity to drive that even higher in the months to come.

正如里奇所說，我們看到了多種路徑。我們將繼續傳遞這項訊息。而且我們也透過 neffyConnect 開展了很多項目，甚至在購買時，如果患者就診並獲得保障。幾個月前我們更新了一件事，那就是我們只需對多箱貨物收取 25 美元的共同支付費用。因此，我們再次將此視為一個機會，在未來幾個月內進一步提高這一水平。

But definitely, really nice increase that we're seeing over the last couple of weeks and months in terms of number of cartons per prescription.

但毫無疑問，在過去幾週和幾個月裡，我們看到每張處方的藥盒數量確實出現了顯著增長。

(Operator Instructions) Ryan Deschner, Raymond James.

（操作員指示）Ryan Deschner、Raymond James。

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

恭喜本季劇本成長。我想問一下，您認為如何才能充分感受到 DTC 活動對 ALK 促銷活動擴大覆蓋範圍以及 1 毫克 neffy 的可用性的影響？您是否覺得這些因素已經足夠快地發揮作用 - 充分利用 8 月份腎上腺素峰值，並且這些因素是否仍然足以加速模式，甚至可能維持第四季度的季度環比增長以達到季節性峰值。

Yes, Ryan, I'll start out on that. So the typical norm is 12 to 16 weeks, but we do know that because of the especially the August, September peak. And we would expect that awareness that we're seeing to have an impact right during that period because people have already had their appointment schedule. A lot of the delay in the impact of DTC is people have to see the ad multiple times. They have to think about it, they do their research, they act on it.

是的，瑞安，我就從那裡開始。因此，典型的標準是 12 到 16 週，但我們確實知道這一點，因為尤其是 8 月和 9 月的高峰。我們預計，我們看到的這種意識會在那段時期產生影響，因為人們已經有了預約安排。DTC 的影響中許多延遲是人們必須多次看到廣告。他們必須思考、研究並採取行動。

And then when they do that, especially in the allergy market, there's around a three-month waiting list to get an appointment. So once they've seen it multiple times and they decide. Hey, I think I'm interested in that schedule and appointment but during the summer period, we do know that a lot of these, especially children will already have their appointments prescheduled. So we're expecting to see a good impact and we expect to see that this does propel us through a nice second half of the year. So -- sorry, what was your second question?

當他們這樣做時，特別是在過敏市場，預約需要等待大約三個月。所以一旦他們看過多次之後他們就會做出決定。嘿，我想我對那個時間表和預約很感興趣，但是在夏季期間，我們確實知道其中的很多人，特別是孩子，已經預先安排好了預約。因此，我們期望看到良好的影響，並且我們期望看到這確實推動我們度過美好的下半年。那麼——抱歉，您的第二個問題是什麼？

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

是的，我們認為這些因素確實足以形成足夠的加速模式，以維持第四季度的環比增長，儘管存在季節性。然後我還想問一下，您認為未來最大的跡像是什麼，表明 Neffy 開始在不經常攜帶或使用腎上腺素的更大的藍天市場中佔據重要地位或開始從中分一杯羹。

Yes. So right now, I think we are pretty confident about the quarter over quarter growth continuing. So that's not in question in my mind, but to answer your question. And then right now, as Eric said, we haven't done really a thorough market analysis of where all the prescriptions are coming from. Anecdotally, we know that there are a lot of people that have never had an auto-injector that have gone and purchased neffy.

是的。因此現在，我認為我們對季度環比成長的持續非常有信心。所以這不是我心中的問題，而是為了回答你的問題。然後現在，正如艾瑞克所說，我們還沒有對所有處方的來源進行徹底的市場分析。有趣的是，我們知道有很多人從未擁有過自動注射器，但卻買了 neffy。

We even had some investors that were allergy patients that have never gone on an auto-injector because they don't like them and have got a neffy. So most of our input right now is anecdotal, but I think that there is a fairly healthy number coming from all segments.

我們甚至有一些投資者是過敏症患者，他們從未使用過自動注射器，因為他們不喜歡它們，而且他們有過敏。因此，我們目前的大部分意見都是軼事，但我認為來自各個領域的意見數量都相當可觀。

But the switchers are the kind of the easier low-hanging fruit patients that have those auto-injectors, they already are conscious about having epinephrine, very accepted epinephrine in general, and then they just don't like either carrier or use the auto-injector, so they're switching. But we do hear anecdotally that there's people coming from all segments.

但是，轉換者是那些擁有自動注射器的、比較容易實現的病人，他們已經意識到需要注射腎上腺素，並且一般情況下非常接受腎上腺素，但他們只是不喜歡載體藥物或使用自動注射器，所以他們正在轉換藥物。但我們確實聽說有來自各個階層的人。

And as Eric said, we'll do a more thorough market analysis later this year after we get -- we want to get to a certain point where we have a certain market share, and then it makes sense to do that kind of work and start really directing where these patients are coming from.

正如埃里克所說，我們將在今年稍後進行更徹底的市場分析，我們希望達到一定的市場份額，然後開展此類工作並開始真正引導這些患者的來源。

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

我現在不想再問任何問題。今天的演講就到此結束了。我們感謝您的參與。現在您可以斷開連接，享受美好的一天。