ARS Pharmaceuticals Inc (SPRY) 2025 Q1 法說會逐字稿

Good morning, and welcome to the ARS Pharmaceuticals conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

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。

I'll now turn the call over to Justin Chakma, Chief Business Officer. Please proceed.

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 first-quarter 2025 earnings conference call. This morning, we issued a press release detailing our financial results and commercial highlights, which is available in the Investor and Media section of our website at ars-pharma.com.

早安，感謝您參加我們的 2025 年第一季財報電話會議。今天上午，我們發布了一份新聞稿，詳細介紹了我們的財務表現和商業亮點，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聯合創始人、總裁兼首席執行官理查德·洛文塔爾 (Richard Lowenthal)，他將回顧公司最近的最新動態和成就；我們的首席商務官 Eric Karas，他將負責我們的商業活動和進展；以及我們的首席財務官凱西·斯科特 (Kathy Scott)，她將提供我們的財務業績和進展和進展；

Before we begin, please note that today's remarks may contain forward-looking statements. Actual results may differ materially. Please refer to our press 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。請參閱我們的新聞稿和美國證券交易委員會 (SEC) 文件以了解更多風險揭露。

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, and thank you all for joining us on this call.

謝謝你，賈斯汀。早上好，感謝大家參加這次電話會議。

We're off to a strong start in 2025 as we continue to execute the nationwide launch of neffy, the first and only needle-free epinephrine treatment approved for Type I allergic reactions, including anaphylaxis. We believe neffy has blockbuster potential, addressing a US market potential of $3 billion net sales in the near term, comprised of about 6.5 million patients who have been prescribed epinephrine over the past three years.

2025 年，我們將迎來一個良好的開端，繼續在全國範圍內推廣 neffy，這是第一個也是唯一一個獲準用於治療 I 型過敏反應（包括過敏性休克）的無針腎上腺素治療藥物。我們相信 neffy 具有巨大的潛力，在短期內可滿足美國 30 億美元淨銷售額的市場潛力，其中包括過去三年內接受過腎上腺素處方的約 650 萬名患者。

Beyond this, an additional 13.5 million diagnosed patients have no epinephrine prescription, and many struggle with needle anxiety and portability concerns. Only 3.2 million patients actually fill their epinephrine autoinjector prescriptions, underscoring the substantial unmet medical need that neffy is uniquely positioned to solve.

除此之外，還有 1,350 萬名確診患者沒有腎上腺素處方，許多人因針頭焦慮和便攜性問題而苦惱。只有 320 萬名患者真正按處方注射了腎上腺素自動注射器，這凸顯了 neffy 具有獨特優勢，可以解決大量未滿足的醫療需求。

With only two quarters of commercialization so far, neffy is gaining traction as a potential new standard of care in this space. In the first quarter of 2025, neffy generated $7.8 million in US net product revenue, reflecting the continuously growing demand among physicians, patients, and caregivers for an alternative to traditional autoinjectors. We started this year with 27% commercial insurance coverage and now have reached 57% coverage, with more payer discussions ongoing.

到目前為止，neffy 的商業化進程才剛開始兩個季度，但它作為該領域潛在的新護理標準，正在獲得越來越多的關注。2025 年第一季度，neffy 在美國創造了 780 萬美元的淨產品收入，反映了醫生、患者和照護者對傳統自動注射器替代品的需求不斷增長。今年年初，我們的商業保險覆蓋率為 27%，現在已達到 57%，並且正在討論更多付款人。

We are entering the peak epinephrine prescribing season during this summer with strong momentum. And with additional health insurance coverage anticipated in the coming months, we also expect to generate additional demand through our DTC consumer awareness campaign that launches tomorrow. This demand is supported by the real-world evidence of adoption by thousands of healthcare providers who have prescribed neffy already. In addition, thousands more have participated in our neffy Experience Program, using neffy during oral food challenges and immunotherapy treatments in the clinic.

今年夏季，我們正以強勁勢頭進入腎上腺素處方高峰期。隨著未來幾個月預計會出現更多健康保險覆蓋，我們也希望透過明天啟動的 DTC 消費者意識活動來產生更多需求。這項需求得到了現實世界證據的支持，數千名醫療保健提供者已經開出了 neffy 處方。此外，還有數千人參加了我們的 neffy 體驗計劃，在診所的口服食物挑戰和免疫療法治療中使用 neffy。

This month, we also reached a major milestone. In addition to our 2-milligram dose for children and adults weighing 30 kilograms or greater, neffy 1-milligram was approved by the FDA in early March of this year and is now available at pharmacies across the US for children weighing between 15 and 30 kilograms. The availability of this pediatric dose is particularly important, as the 1-milligram dose represents 23% of all epinephrine units dispensed in 2024, and more than half of all epinephrine prescriptions for children. neffy offers caregivers and young patients a reliable and easy-to-use option, and we ensured that it was available before summer travel, camps, and back-to-school preparations.

本月，我們也達到了一個重要的里程碑。除了我們針對體重 30 公斤或以上的兒童和成人的 2 毫克劑量外，neffy 1 毫克劑量已於今年 3 月初獲得 FDA 批准，目前已在美國各地的藥局為體重 15 至 30 公斤的兒童提供。這種兒科劑量的可用性尤其重要，因為 1 毫克劑量佔 2024 年發放的所有腎上腺素單位的 23%，佔兒童所有腎上腺素處方的一半以上。 neffy 為護理人員和年輕患者提供了可靠且易於使用的選擇，我們確保在夏季旅行、夏令營和返校準備之前可以使用它。

To further strengthen our commercial reach, including to key pediatricians, we recently expanded our strategic collaboration with ALK-Abelló, a global leader in allergy care, ahead of this peak summer prescribing season. This co-promotion agreement expands our direct promotional network for neffy to over 20,000 healthcare providers across the United States, including targeted outreach to approximately 9,000 pediatricians, accelerating our efforts to position neffy as the leading epinephrine option for both adults and children.

為了進一步加強我們的商業影響力，包括涵蓋主要的兒科醫生，我們最近在夏季處方高峰期到來之前擴大了與過敏護理領域的全球領導者 ALK-Abelló 的策略合作。這項聯合推廣協議將我們的 neffy 直接推廣網絡擴展至全美超過 20,000 家醫療保健提供商，其中包括針對約 9,000 名兒科醫生的推廣，從而加快我們將 neffy 定位為成人和兒童領先的腎上腺素選擇的努力。

This partnership builds on our broader global relationship with ALK. Under this agreement, ARS will continue to focus on allergists and the highest volume pediatricians and PCPs in the United States and retains full control over all aspects of US commercialization, including marketing, medical affairs, market access, production, and distribution. Lastly, regulatory reviews are underway for neffy in the UK, Canada, Japan, China, and Australia, with decisions and commercial launches in these countries expected to begin in mid-2025 through the first half of 2026.

此次合作建立在我們與 ALK 更廣泛的全球關係的基礎上。根據該協議，ARS 將繼續專注於美國過敏症專家和數量最多的兒科醫生和 PCP，並完全控制美國商業化的所有方面，包括行銷、醫療事務、市場准入、生產和分銷。最後，英國、加拿大、日本、中國和澳洲正在對 neffy 進行監管審查，預計這些國家的決策和商業發布將於 2025 年中期至 2026 年上半年開始。

To summarize, this is a year of execution for ARS. We aim to deepen physician engagement, expand access, and lay the groundwork for a global commercial footprint for neffy, supported by our partners.

總而言之，這是 ARS 執行的一年。我們的目標是在合作夥伴的支持下，加深醫生的參與、擴大管道並為 neffy 的全球商業足跡奠定基礎。

I'll turn the call over to Eric for a more detailed review of our commercial progress.

我將把電話轉給 Eric，以便他更詳細地審查我們的商業進度。

Thanks, Rich.

謝謝，里奇。

Our commercial strategy is built on three key pillars: driving healthcare provider adoption, securing market access, and increasing patient awareness. Since launch, our sales team has directly engaged over 10,000 healthcare providers. More than 50% of these providers have prescribed neffy. Of the prescriptions submitted to date, nearly 90% have come from top-decile targets. We view this as a strong endorsement from leading experts who treat the highest number of patients at risk for allergic reactions.

我們的商業策略建立在三大支柱之上：推動醫療保健提供者的採用、確保市場准入和提高病患意識。自推出以來，我們的銷售團隊已直接與 10,000 多家醫療保健提供者合作。其中超過 50% 的供應商都開出了 neffy。迄今為止提交的處方中，近 90% 來自排名前十分之一的目標族群。我們認為這是來自治療過最多過敏反應風險患者的頂尖專家的強烈認可。

Approximately 2,500 healthcare providers have also enrolled in our neffy Experience Program, and over 13,000 units have been placed in offices for use during anaphylactic events. This hands-on experience has led to numerous physician testimonials that highlight the positive impact neffy is having in clinical practice. With the recent availability of the 1-milligram dose, we'll be adding it to our neffy Experience Program, and we'll collect additional information on both the 1-milligram and 2-milligram doses. We plan to share the physician survey data from our neffy Experience Program in various medical forums later this year.

大約有 2,500 名醫療保健提供者也加入了我們的 neffy 體驗計劃，並且有超過 13,000 個裝置被放置在辦公室中，以便在過敏事件期間使用。這種親身體驗得到了眾多醫生的認可，強調了 neffy 在臨床實踐中產生的積極影響。隨著最近 1 毫克劑量的推出，我們將把它添加到我們的 neffy 體驗計劃中，並且我們將收集有關 1 毫克和 2 毫克劑量的更多資訊。我們計劃在今年稍後在各種醫療論壇上分享來自我們的 neffy 體驗計劃的醫生調查數據。

As Rich mentioned, we continue to make progress in payer access. We have secured commercial coverage across more than 30 formulary platforms, now including UnitedHealthcare. Currently, over 57% of all US commercial life have access to neffy. We are approaching a tipping point in market access that will enable more healthcare providers to prescribe neffy without restrictions.

正如里奇所提到的，我們在付款人訪問方面繼續取得進展。我們已獲得 30 多個處方平台的商業保險，現在包括 UnitedHealthcare。目前，超過 57% 的美國商業生活都可以使用 neffy。我們正接近市場准入的臨界點，這將使更多的醫療保健提供者能夠不受限制地開出 neffy 處方。

In the coming months, as patients schedule appointments and visit their allergy care providers, we anticipate that access to neffy will become quicker and easier. For patients with commercial insurance, our assistance program ensures that most individuals will only have a $25 copay, which is less than the typical $40 for a generic injector.

在接下來的幾個月裡，隨著患者安排預約並拜訪他們的過敏護理提供者，我們預計獲得 neffy 的機會將變得更快、更容易。對於擁有商業保險的患者，我們的援助計劃確保大多數個人只需支付 25 美元的共付額，低於通用注射器的典型 40 美元。

We are making it easier for patients, as the copay support is now automatically applied at the point of sale in retail pharmacies. Additionally, for eligible patients who are uninsured or underinsured, we provide neffy at no cost through our Patient Assistance Program. These programs reflect our commitment to ensure that all patients at risk of an allergic reaction have access to this potentially life-saving treatment.

我們正在為患者提供便利，因為現在可以在零售藥局的銷售點自動應用共付額支援。此外，對於沒有保險或保險不足的合格患者，我們透過患者援助計劃免費提供 neffy。這些項目體現了我們的承諾，確保所有有過敏反應風險的患者都能獲得這種可能挽救生命的治療。

As we turn to the third pillar of our commercial strategy, patient awareness, we are excited to announce the launch of a broad and comprehensive direct-to-consumer campaign that will redefine the epinephrine landscape and establish neffy as a household name. Our campaign, titled Hello neffy, Goodbye Needles, will debut tomorrow. We are utilizing a multi-channel strategy to reach patients, parents, and caregivers where they are, including connected TV, broadcast, social media platforms, health-related websites, prints, pharmacies, and point-of-care settings.

當我們轉向商業策略的第三大支柱——患者意識時，我們很高興地宣布啟動一項廣泛而全面的直接面向消費者的活動，這將重新定義腎上腺素的格局，並使 neffy 成為家喻戶曉的品牌。我們的活動名為“你好，妮菲，再見，尼德爾斯”，將於明天首次亮相。我們正在利用多通路策略聯繫患者、父母和照護人員，包括連網電視、廣播、社群媒體平台、健康相關網站、印刷品、藥局和照護點。

Our data-driven media plan aims to engage high-value audiences during key seasonal periods, such as back to school and the availability of our 1-milligram dose. We expect to reach 95% of severe allergy patients and their caregivers.

我們的數據驅動媒體計畫旨在關鍵季節期間（例如返校季和 1​​ 毫克劑量供應期間）吸引高價值受眾。我們期望能夠涵蓋 95% 的嚴重過敏患者及其照護者。

Our investment is essential for achieving our goals of raising awareness and encouraging adoption. Every aspect of this campaign is designed to empower patients and their caregivers to position neffy as a standard of care and drive prescription growth. We believe our DTC campaign could generate significant revenue in the second half of 2025 and beyond while establishing neffy as a leading brand in severe allergy care.

我們的投資對於實現提高認識和鼓勵採用的目標至關重要。活動的每個方面都旨在幫助患者及其照護者將 neffy 定位為護理標準並推動處方成長。我們相信，我們的 DTC 活動可以在 2025 年下半年及以後產生可觀的收入，同時將 neffy 打造為嚴重過敏護理領域的領先品牌。

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. The details of our financial results can be found in our earnings press release and 10-Q filing, so I'll provide a summary.

謝謝你，埃里克。我們的財務表現詳情可在我們的收益新聞稿和 10-Q 文件中找到，因此我將提供摘要。

For the first quarter of 2025, we recorded total revenue of $8 million. This is comprised of $7.8 million in US net product revenue for neffy, and we expect to see a continued ramp-up in product revenue as our commercial efforts accelerate. In addition, we had $0.2 million in collaboration revenue, which was the recognition of deferred revenue from performance obligations related to our collaboration and license agreement with ALK.

2025 年第一季度，我們的總收入為 800 萬美元。這包括 neffy 在美國獲得的 780 萬美元淨產品收入，我們預計隨著商業努力的加速，產品收入將持續成長。此外，我們還有 20 萬美元的合作收入，這是與 ALK 的合作和授權協議相關的履約義務的遞延收入確認。

Under our new co-promotion agreement with ALK, ARS will continue to recognize all net product revenue in the US and retain full responsibility for commercialization. neffy will be detailed by ALK sales representatives in primary position for the first two years and co-primary position during the last two years of the four-year agreement. Additional terms of our co-promotional agreement can be found in our 8-K and 10-Q filings.

根據我們與 ALK 達成的新聯合推廣協議，ARS 將繼續確認美國的所有淨產品收入，並對商業化承擔全部責任。在四年協議的前兩年，ALK 銷售代表將指派 neffy 擔任主要職位，在後兩年擔任共同主要職位。我們的聯合促銷協議的附加條款可以在我們的 8-K 和 10-Q 文件中找到。

In terms of our operating expenses, cost of goods sold for the first quarter was $1.1 million. Our COGS continues to benefit from some inventory that was expensed prior to FDA approval in August 2024.

就我們的營運費用而言，第一季的銷售成本為 110 萬美元。我們的 COGS 繼續受益於 2024 年 8 月 FDA 批准之前已計入費用的部分庫存。

R&D expenses for the first quarter were $3 million, primarily related to clinical expenses and product development. Sales, general, and administrative expenses were $41.1 million for the first quarter, largely tied to personnel, sales, and marketing expenses associated with the commercialization of neffy in the US.

第一季的研發費用為 300 萬美元，主要用於臨床費用和產品開發。第一季的銷售、一般和行政費用為 4,110 萬美元，主要與 neffy 在美國商業化相關的人員、銷售和行銷費用有關。

As Eric noted, we are launching a comprehensive DTC campaign tomorrow, which has a planned investment of $40 million to $50 million for the remainder of 2025. The bulk of this expense will be recognized in our SG&A in the second and third quarters of the year, and we believe we will start seeing the benefits of the DTC campaign starting in Q3 2025.

正如 Eric 所說，我們明天將啟動一項全面的 DTC 活動，計劃在 2025 年剩餘時間內投資 4,000 萬至 5,000 萬美元。這筆費用的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) 中，我們相信從 2025 年第三季開始我們將開始看到 DTC 活動帶來的好處。

Also, with the planned DTC spend and additional investments in pediatric access and commercialization with our partner ALK, we project total 2025 operating expenses of between $210 million and $220 million, excluding stock-based compensation and cost of goods sold. The ALK co-promotion agreement adds approximately $8 million in operating expense to the previous guidance for 2025. We believe this is a solid investment in our future growth potential in the pediatric market.

此外，加上計劃中的 DTC 支出以及與合作夥伴 ALK 在兒科治療准入和商業化方面的額外投資，我們預計 2025 年的總營運費用將在 2.1 億美元至 2.2 億美元之間，不包括股票薪酬和銷售成本。ALK 聯合推廣協議將為 2025 年的先前指引增加約 800 萬美元的營運費用。我們相信這是對我們未來兒科市場成長潛力的穩健投資。

ARS's portion of the commercial expenses under the co-promotion agreement with ALK will be recorded as an expense on our P&L for the first year of the agreement, but will accrue and not be paid in cash to ALK until the second year of the agreement. Any future performance-based payments to ALK based on achieving certain market share thresholds are expected to be recognized as operating expenses.

根據與 ALK 簽訂的聯合推廣協議，ARS 應承擔的商業費用部分將在協議第一年的損益表中記錄為費用，但會一直累積到協議第二年才會以現金形式支付給 ALK。任何基於達到特定市場份額門檻而向 ALK 支付的未來績效付款預計都將被確認為營運費用。

Lastly, we reported a net loss of $33.9 million, or $0.35 per share, for the first quarter. Overall, we are well capitalized today with a disciplined and strategic investment approach to support the commercial execution of neffy while also advancing development of our nasal epinephrine program in new indications such as urticaria.

最後，我們報告第一季淨虧損 3,390 萬美元，即每股 0.35 美元。整體而言，我們目前資本充足，採用嚴謹的策略性投資方式來支持 neffy 的商業執行，同時推進我們的鼻用腎上腺素計畫在蕁麻疹等新適應症方面的發展。

As of March 31, 2025, we had cash, cash equivalents, and short-term investments of $275.7 million. We reiterate today that based on our current plans, we have an operating runway of at least three years.

截至 2025 年 3 月 31 日，我們的現金、現金等價物及短期投資為 2.757 億美元。我們今天重申，根據我們目前的計劃，我們的營運跑道至少還有三年。

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.

謝謝你，凱西。

As you heard, we are executing from a position of strength. We've seen the momentum across the board, from strong early revenue and formulary wins to physician testimonials and real-world adoption. This reinforces our belief that neffy is a truly transformative product. I am proud of the work our team has done, and I'm grateful to our partners, the medical and advocacy communities, and above all else, the patients and caregivers for their support and enthusiasm.

正如您所聽到的，我們正以強勢姿態執行任務。我們已經看到了全面的發展勢頭，從強勁的早期收入和處方集勝利到醫生的推薦和現實世界的採用。這強化了我們的信念：neffy 是一款真正具有改變意義的產品。我為我們團隊所做的工作感到自豪，並感謝我們的合作夥伴、醫療和倡導團體，最重要的是感謝患者和照護者的支持和熱情。

Operator, please open the line for questions.

接線員，請打開熱線來回答問題。

(Operator Instructions) Ryan Deschner, Raymond James.

（操作員指示）Ryan Deschner、Raymond James。

Good morning. Thanks for the question. I'm curious how much of the 1Q sales figure is attributed to inventory and how you're thinking about inventory [contribution] over the next two quarters, going into the peak epinephrine season as well as following it, and I have a follow-up.

早安.謝謝你的提問。我很好奇第一季的銷售數據有多少歸功於庫存，以及您如何看待未來兩個季度的庫存[貢獻]，進入腎上腺素高峰季節以及之後的季節，我會進行後續跟進。

Yeah, hi. This is Rich Lowenthal, Ryan. Our first-quarter numbers were very little influenced by inventory. We're seeing fairly steady inventories at this point, and it was prior to the 1-milligram being launched, so this was all 2-milligram sales, of course. But we don't think anybody had much influence on the sales this quarter.

是的，你好。我是 Rich Lowenthal，Ryan。我們第一季的數據受庫存的影響很小。目前我們看到的庫存相當穩定，這是在 1 毫克推出之前，所以當然都是 2 毫克的銷售。但我們認為沒有人對本季的銷售產生太大影響。

Got it. And what would the growth in that discount look like in the first quarter? How meaningful would that change from fourth quarter to first quarter?

知道了。那麼第一季的折扣成長情況如何？從第四季到第一季度，這種變化有多大意義？

Kathy can give you the full details, but as expected, the growth in that will slowly come down towards the 50% mark. We're seeing a good uptake of insurance coverage and fewer cash sales, and that will obviously bring down our gross to net when we get better insurance coverage.

凱西 (Kathy) 可以為您提供全部細節，但正如預期的那樣，成長率將緩慢下降至 50% 左右。我們看到保險覆蓋率的提高和現金銷售的減少，當我們獲得更好的保險覆蓋率時，這顯然會降低我們的毛收入和淨收入。

But Kathy, do you want to speak to the gross to net in this quarter?

但是凱西，你想談談本季的毛利與淨利之比嗎？

Sure. Good morning, Ryan. Yes, Q4 was definitely a higher gross to net than Q1. As Rich said, our payment coverage is coming online, and we were kind of hovering around the 60% -- a little over 60% for Q1, but do expect that to go down to closer to 50% as we go forward in 2025.

當然。早安，瑞安。是的，第四季的毛利率肯定高於第一季。正如里奇所說，我們的支付覆蓋率即將上線，第一季我們的支付覆蓋率徘徊在 60% 左右 - 略高於 60%，但預計到 2025 年，這一比例將下降到接近 50%。

Thanks, Kathy. Thanks, Rich.

謝謝，凱西。謝謝，里奇。

Josh Schimmer, Cantor.

喬許希默（Josh Schimmer），領唱。

Thanks for taking the questions. Just a couple of quick ones. First, when you've worked through the inventory on hand, what do you expect cost of goods to settle out at? And then for the, I think, 50% of commercial lives that have access, can you confirm that there are no prior author requirements for access to neffy for them?

感謝您回答這些問題。僅舉幾例。首先，當您處理完手邊的庫存後，您預計商品成本會達到多少？然後，我認為對於 50% 可以訪問的商業生活，您能否確認他們訪問 neffy 不需要事先獲得作者同意？

Sorry. Can you repeat the second question, Josh?

對不起。喬希，你能重複第二個問題嗎？

The update was over 50% of commercial lives have access to neffy. Just want to make sure that there are no prior author requirements for those patients.

更新後，超過 50% 的商業生活都可以使用 neffy。只是想確保這些患者沒有先前的作者要求。

Right. Okay, so let's start there. Currently, about 57% of people have coverage with no prior authorization. If you count with prior authorization, we're probably close to 90%, Josh. So we're not really considering the prior authorization as a full coverage, partial but not full.

正確的。好的，我們從那裡開始。目前，約有 57% 的人無需事先授權即可獲得保險。如果你算上事先授權，我們可能接近 90%，喬希。所以我們其實並不認為事先授權是一種全面覆蓋，而只是部分覆蓋，而不是全部。

We do see good approval rates of prior authorizations between 60% and 80%, depending on the insurer. But again, we've got to get the doctors to write those prior authorizations. So that's a barrier. But 57% right now have coverage on neffy without any prior authorization or any other paperwork required. They can get a prescription, go to the pharmacy, and pick up the prescription at the pharmacy.

我們確實看到事先授權的批准率較高，介於 60% 到 80% 之間，具體取決於保險公司。但同樣，我們必須讓醫生簽署這些事先授權。所以這是一個障礙。但目前 57% 的人無需事先授權或任何其他文書即可在 neffy 上投保。他們可以拿到處方，去藥房，然後在藥房領取處方。

And then with regards to the first question, I don't believe we've given details on the COGS, other than generally the cost of goods are in the ballpark of less -- they're pretty low. I don't think we've given exact guidance. Have we, Justin, on this?

然後關於第一個問題，我認為我們沒有提供有關 COGS 的詳細信息，除了一般來說商品成本在較低水平 - 它們相當低。我認為我們沒有給出確切的指導。賈斯汀，我們有這個嗎？

No. I think the question was whether, as we use up our inventory, what happens to cost of goods.

不。我認為問題在於，當我們用完庫存時，商品成本會發生什麼變化。

Kathy, do you want to speak to that?

凱西，你想談談這個嗎？

Sure. No, we definitely have, as included in our 10-Q, we've got some no-cost inventory that was expensed prior to FDA approval. So as we wean that into our inventory, which should be kind of over the next 18 months or so, we would expect that inventory at COGS would -- the COGS would increase slightly. But for the most part, that zero-cost inventory is the raw material. So we're still paying for manufacturing for those -- for the inventory that's being COGS in the near term.

當然。不，我們肯定有，正如我們的 10-Q 中所述，我們有一些在 FDA 批准之前已計入費用的無成本庫存。因此，隨著我們將其逐漸納入庫存，這應該在未來 18 個月左右，我們預計 COGS 的庫存將 - COGS 將略有增加。但在大多數情況下，零成本庫存就是原料。因此，我們仍在為這些產品的製造付費——這些產品是短期內的 COGS 庫存。

Okay. Thank you.

好的。謝謝。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員指示）Roanna Ruiz，Leerink Partners。

Hey. Morning, everyone. A couple for me. Could you talk about the strength of the neffy Experience Program in helping to convert possible later adopter physicians into broader prescribers of neffy? And what has the feedback been so far in terms of some details you've heard recently about use of neffy there? Any updates on single versus twice dosing of neffy, for example?

嘿。大家早安。對我來說是一對。您能否談談 neffy 體驗計劃在幫助將潛在的後期採用者醫生轉變為更廣泛的 neffy 處方者方面的優勢？就您最近聽到的有關使用 neffy 的一些細節而言，到目前為止，反饋如何？例如，關於單次服用和兩次服用 neffy 有什麼更新嗎？

Yeah. So I can give you a little update. So as Eric pointed out earlier, where the neffy Experience Program's been very, very successful, more than 2,500 physicians are enrolled and have neffy. A lot of them have used everything we provided. So we are going to be expanding the program to not only include the 1-milligram, but possibly also for those doctors that have already used their supply of neffy 2-milligram to give them additional supply of 2-milligram.

是的。因此我可以向你提供一些最新消息。正如 Eric 之前指出的那樣，neffy 體驗計劃非常非常成功，已有超過 2,500 名醫生註冊並使用了 neffy。他們中的許多人使用了我們提供的所有產品。因此，我們將擴大該計劃，不僅包括 1 毫克，還可能為那些已經使用 2 毫克 neffy 供應的醫生提供額外的 2 毫克供應。

With the outcome so far, we're seeing very good results just by surveying the sites that have actually administered neffy to patients. The experiences are coming back very positive. We're still -- the results are basically looking like injections. So still around 90% are getting a response with a single dose of neffy; about 10% are needing a second dose. That's the same as what's observed with injection. So we believe that's very positive feedback.

從目前的結果來看，我們僅透過調查實際為患者使用 neffy 的站點就看到了非常好的結果。這些經驗都得到了非常正面的回報。我們仍然——結果基本上看起來像注射。因此，仍有約 90% 的患者透過一次劑量的 neffy 獲得反應；約有 10% 的人需要第二劑。這與注射時觀察到的情況相同。所以我們相信這是非常正面的回饋。

And in general, the doctors have been very positive about their experience so far. So we are planning to potentially publish some of this shortly. We could then obviously be able to use that to help other doctors that may be still reluctant or still questioning whether real-world data is available, because this is a very large subset of real-world data right now.

總體而言，醫生們對他們迄今為止的經歷都持非常積極的態度。因此我們計劃很快發布其中的一些內容。顯然，我們可以利用它來幫助那些可能仍然猶豫或質疑是否有真實世界數據的醫生，因為這是目前真實世界數據的一個非常大的子集。

And then we are looking forward to the 1-milligram being out there and being used as well, since a lot of these children that get oral food challenge are younger. And then maybe towards the American College meeting, we may also put out an abstract on the neffy Experience Program and the results.

然後，我們預期 1 毫克的劑量能夠面世並使用，因為許多接受口服食物挑戰的兒童年齡較小。然後也許在美國大學會議上，我們可能還會發布有關 neffy 體驗計劃及其結果的摘要。

Got it. That helps. And a quick follow-up from me. On the payer front and insurance coverage, how are you tracking against your goal of, I think, 80% commercial lives by 3Q? And could you remind us, are there any payers still in negotiations or in progress right now that you would need to secure to get there?

知道了。這有幫助。我接下來會進行快速跟進。在付款人和保險覆蓋方面，我認為到第三季度，你們實現商業化覆蓋率達到 80% 的目標進度如何？您能否提醒我們，目前是否還有任何付款人仍在談判或正在進行中，而您需要確保這些付款人能夠達成目標？

Yeah. I think, well, there's certainly a number of payers that we're still working with. We do have the contract with Zinc, but we're still working with Caremark and Aetna to cover neffy under that agreement. So that's obviously a big insurer that we're still working with to get final agreement on.

是的。我認為，我們肯定仍在與一些付款人合作。我們確實與 Zinc 簽訂了合同，但我們仍在與 Caremark 和 Aetna 合作，根據該協議為 neffy 提供保險。顯然，我們仍在與一家大型保險公司合作以達成最終協議。

We're also working with Prime and other Blue Cross companies, of course, to get an agreement with a lot of them. We do have some Blue Cross companies already covering. We generally have a scorecard on our website, so it's fairly transparent as to who's covering and who's still pending coverage.

當然，我們也在與 Prime 和其他 Blue Cross 公司合作，與其中許多公司達成協議。我們確實已經有一些藍十字公司覆蓋範圍。我們的網站上通常會有記分卡，因此對於誰正在承保以及誰仍在等待承保，它是相當透明的。

But again, even Caremark right now is accepting PAs and approving at a very high percentage, as I said, in the upper range of the 60% to 80% I mentioned. So they are very, very quickly approving of prior authorizations, but they are still requiring a prior authorization for neffy at this point. But we are trying to work through that.

但是，正如我所說，即使是 Caremark 現在也接受 PA 並且批准率非常高，在我提到的 60% 到 80% 的上限範圍內。因此，他們非常非常迅速地批准了事先授權，但目前他們仍然要求對 neffy 進行事先授權。但我們正在努力解決這個問題。

So those are some of the bigger ones that we want to try to get across the finish line to get towards that 80% coverage. But in general, with prior authorization, we're already above 90%. There's only a handful of companies that are actually blocking neffy right now, so that's actually very positive as well.

因此，這些都是我們希望努力完成的一些較大的任務，以實現 80% 的覆蓋率。但總體來說，透過事先授權，我們已經超過 90%。目前只有少數幾家公司實際上在阻止 neffy，所以這實際上也是非常積極的。

Yeah, sounds good. Thanks.

是的，聽起來不錯。謝謝。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

Hey, guys. Thanks for the questions. I was wondering if you could provide any detail on the number of prescriptions that were actually written and filled in the quarter as we try to understand what the sort of capture rate of IQVIA and other providers are. And could you provide any color on -- you've talked about the PAs and the high success rate there. Can you talk about how many of the prescriptions in the past quarter have been covered versus required prior off?

嘿，大家好。感謝您的提問。我想知道您是否可以提供本季度實際開立和填寫的處方數量的詳細信息，因為我們試圖了解 IQVIA 和其他提供者的捕獲率。您能否提供一些詳細資訊——您談到了 PA 及其高成功率。您能否談談過去一個季度中有多少處方已被覆蓋以及有多少處方是之前要求的？

Okay. I think, Eric, you should probably take that question.

好的。艾瑞克，我想你應該回答這個問題。

Sure. Sounds good. So first, when we look at the prescription data through IQVIA, we've talked about this before, and it's not 100% capture of everything. Our cash prescriptions through Blink are not covered. But roughly, if you look at the extended unit data on a weekly basis, it's about 13,000 prescriptions or units. But again, that's not a complete capture.

當然。聽起來不錯。首先，當我們透過 IQVIA 查看處方資料時，我們之前已經討論過這個問題，它並不能 100% 捕捉所有內容。我們透過 Blink 開出的現金處方不包含在內。但粗略地說，如果按週查看擴展單位數據，則大約有 13,000 張處方或單位。但同樣，這並不是一個完整的捕捉。

And then as far as the PAs, if you look at the beginning of this year, we were looking at about 70% of prescriptions required a PA. That's down to about 45%. So as Rich went through and I went through our comments, we're seeing the PAs come down, which is a very positive thing.

至於 PA，如果你看看今年年初，我們發現大約 70% 的處方都需要 PA。這一比例下降至約 45%。因此，當我和 Rich 討論我們的評論時，我們看到 PA 下降了，這是一件非常積極的事情。

We work closely with the doctors and obviously their staff to submit the PAs. We're continuing to drive that. And I think with six to seven months under our belt, we have really good insights in terms of the criteria that's evaluated in terms of an approval of the PA. So our sales team continues to share that information with office managers and those individuals in the office that are responsible for those PAs.

我們與醫生及其工作人員密切合作，提交 PA。我們將繼續推動這項進程。我認為，經過六到七個月的努力，我們對 PA 批准的評估標準有了很好的了解。因此，我們的銷售團隊會繼續與辦公室經理以及辦公室中負責這些 PA 的人員分享這些資訊。

Great, thanks. Could you also talk about the sort of overlap between the neffy experience docs and the high prescribers? I mean, are the 2,500 odd doctors in the neffy Experience Program, are they all in that sort of the high prescribing bucket at the moment? How's that sort of conversion looking?

太好了，謝謝。您能否也談談經驗豐富的醫生和高級處方醫生之間的重疊之處？我的意思是，Neffy 體驗計劃中的 2,500 多名醫生目前是否都屬於這種高處方人群？這種轉變看起來怎麼樣？

Yeah. Rich, I can take that one, too. So when we start looking at kind of our, first, I'll say from a decile perspective, about 81% of our decile 10s, that's the highest volume of physicians, are writing for neffy, which is great. If you look at the combination of 8s, 9s and 10s, it's about 75%. We do see that doctors that are part of the experience program, on average, are writing about 2.5 to 3 times more than the overall average that we're seeing at a national level.

是的。里奇，我也可以接受這個。因此，當我們開始研究時，首先，從十分位數的角度來看，大約有 81％ 的十分位數 10，即最多的醫生，正在為 neffy 寫作，這很好。如果你看一下 8、9 和 10 的組合，它大約是 75%。我們確實看到，參與體驗計畫的醫生的書寫量平均比全國整體平均水平高出 2.5 到 3 倍。

So that program is exactly doing what we expected in terms of building trust and confidence. Doctors really like it because they're able to get firsthand experience. And when they talk to patients, they can reference that and tell stories about what they've seen in their own clinical practice.

因此，該計劃在建立信任和信心方面確實達到了我們的期望。醫生們非常喜歡它，因為他們能夠獲得第一手經驗。當他們與患者交談時，他們可以參考這一點並講述他們在自己的臨床實踐中看到的故事。

So as Rich said, we're looking to get that out more broadly in the second half of the year. But we're starting to do that already, too, with our peer to peer education, our speaker programs. Most of the speakers are part of the program and have had firsthand experience. So they're able to share that when they're speaking to other healthcare providers and their peers. So we're going to continue to drive that because we clearly know that this program is really hitting the mark of what we expected it to do.

正如里奇所說，我們希望在今年下半年更廣泛地推廣這項措施。但我們已經開始這樣做了，透過同儕教育和演講者計劃。大多數演講者都參與過該計劃並擁有第一手經驗。因此，當他們與其他醫療保健提供者和同行交談時，他們能夠分享這一點。因此，我們將繼續推動這一進程，因為我們清楚地知道，該計劃確實達到了我們的預期。

Got it. Thanks.

知道了。謝謝。

Andre Argyrides, Oppenheimer.

安德烈·阿吉里德斯，奧本海默。

All right. Good morning, and thanks for taking our question. Sorry for the disruption there earlier. Rich, can you just talk about how you're thinking about the rest of the year in terms of -- I know you're not providing guidance, but how the Q1 results are tracking for that inflection point in the second half of the year? Thanks.

好的。早安，感謝您回答我們的問題。很抱歉剛才造成打擾。里奇，你能不能談談你對今年剩餘時間的看法——我知道你沒有提供指導，但是第一季的業績如何追蹤下半年的轉折點？謝謝。

Yeah. I think we're still tracking according to plan and exactly where we believe we should be right now. We are obviously expecting to see that inflection in the third quarter. The August-September timeframe tends to be peak sales for this product, especially with the children.

是的。我認為我們仍在按照計劃進行，並且正處於我們認為現在應該處於的位置。我們顯然預期第三季會出現這種轉變。八月至九月期間往往是該產品的銷售高峰期，尤其是受到兒童的青睞。

Our sales are still heavily weighted towards children with the 2-milligram. We expect that to even be expanded, greater focus on children with the 1-milligram. So we do expect to see that inflection point start this summer. And with the DTC campaign and 1-milligram available, we think that that's where we'll start to see a real upturn in market share.

我們的銷售主要仍是針對 2 毫克劑量的兒童。我們希望這一範圍能進一步擴大，並更加關注 1 毫克劑量的兒童。因此，我們確實預計拐點將在今年夏天開始。隨著 DTC 活動的開展和 1 毫克產品的上市，我們認為我們將開始看到市場份額的真正上升。

And then just a quick follow-up, do you still think that prior offs are the biggest impediment at the moment? And so when you get to the broader access that you're guiding towards that that will be a real a real boost.

然後快速跟進一下，您是否仍然認為之前的失敗是目前最大的障礙？因此，當您獲得您所引導的更廣泛的訪問權限時，這將是一個真正的推動力。

Yeah. I mean, I think the prior authorizations when we have low insurance coverage is an impediment when we start to get higher and higher up in insurance coverage. There is fewer prior off the docks have to deal with. And they're more than happy to write prior authorizations. They just don't want to write too many. So it's a matter of volume.

是的。我的意思是，我認為，當我們的保險覆蓋率較低時，事先授權會阻礙我們開始提高保險覆蓋率。之前需要處理的事情越來越少。他們非常樂意簽署事先授權書。他們只是不想寫太多。所以這是一個數量的問題。

And so we do see the number of prior authorizations coming down. We see the approval rates increasing. So that's a good sign. And that encourages doctors to continue to write prior authorizations for those patients that are not getting automatic insurance coverage without paperwork. So that's encouraging.

因此我們確實看到事先授權的數量正在下降。我們看到批准率正在上升。這是一個好兆頭。這鼓勵醫生繼續為那些沒有獲得自動保險覆蓋的患者寫事先授權。這令人鼓舞。

So we do think it's a headwind. But it becomes less and less and less as time goes by, because the remaining patients that are not covered are those insurance companies that are delaying. They're -- the doctors are more willing to write the prior authorizations because there's just fewer of them.

所以我們確實認為這是一個阻力。但隨著時間的推移，這種情況會越來越少，因為剩下沒有保障的病人都是那些保險公司在拖延。他們－醫生更願意簽署事先授權，因為授權的數量較少。

Does that make sense?

這樣有道理嗎？

It does. Thanks, and congrats on the quarter. Thanks. I'll jump back to the queue.

確實如此。謝謝，恭喜本季取得佳績。謝謝。我將重新回到隊列。

Louise Chen, Scotiabank.

加拿大豐業銀行的 Louise Chen。

Hi. Thanks for taking my questions here. So I just wanted to ask you how we can think about the sales targets that ALK has to hit in order to get to the performance-based payments that you've discussed.

你好。感謝您在這裡回答我的問題。所以我只是想問您，我們如何看待 ALK 必須達到的銷售目標才能實現您所討論的基於績效的付款。

And then the second thing is, what is your market share now? Where do you hope to be by the end of the year? Thank you.

第二件事是，您現在的市佔率是多少？您希望今年底能達到什麼水準？謝謝。

Eric, I think you should take that question, if okay.

艾瑞克，如果可以的話，我想你應該回答這個問題。

Yeah, let me take the second part first. So when you look at a market share overall in the category of the basket of epinephrine across the board, brand and generic, we have about a 1.3% share. But what we also focus on, more importantly, is our targets of the doctors that we're calling on directly. That's about 6.2. And then we also have super targets, which is about 7.5. So these are doctors that we spend extra time in in terms of our promotion and focus.

是的，我先講第二部分。因此，當您查看腎上腺素產品類別（包括品牌藥和仿製藥）的整體市場份額時，我們的份額約為 1.3%。但更重要的是，我們關注的是我們直接拜訪的醫生的目標。大約是 6.2。然後我們還有超級目標，大約是 7.5。因此，我們在推廣和關注這些醫生方面花費了額外的時間。

As far as the ALK co-promote, this is a great opportunity that we are very excited about. Obviously, we're able to expand our footprint, the number of reps. We're going to grow from about 12,500 positions with direct promotion up to about 20,000. So we have some milestone targets in terms of market share that we think is very reasonable to hit those targets.

就 ALK 共同推廣而言，這是一個令我們非常興奮的絕佳機會。顯然，我們能夠擴大我們的足跡和代表數量。我們的直接晉升職位數量將從約 12,500 個增加至約 20,000 個。因此，我們在市佔率方面設定了一些里程碑目標，我們認為實現這些目標是非常合理的。

And especially, as we've articulated, we've got so many catalysts coming up in the next three to six months here with the 1-milligram, the DTC commercial, and continued pair coverage improving. So we feel really confident about this co-promote and look forward to the impact that they're going to have in the pediatric space.

特別是，正如我們所闡述的，未來三到六個月內，我們將迎來許多催化劑，包括 1 毫克、DTC 商業以及持續的配對覆蓋改善。因此，我們對此次聯合推廣充滿信心，並期待它們在兒科領域的影響。

Okay. Thank you.

好的。謝謝。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

Hey, thanks for the follow-up. I just wanted to confirm, Kathy, I think you said you're expecting most of the DTC marketing to be in Q2 and Q3. So I wanted to confirm, should we sort of expect a tail off in Q4, or is it more that most of the sort of growth will be Q2 and Q3 and then it will be steady thereafter?

嘿，謝謝你的跟進。凱西，我只是想確認一下，我認為你說過你預計大部分 DTC 行銷將在第二季和第三季進行。所以我想確認一下，我們是否應該預期第四季會出現成長放緩，或者大部分成長將出現在第二季和第三季度，然後保持穩定？

Sure, we do expect to spend some in Q4, but as I said in my remarks, the majority in Q2 and Q3. And as Rich said, the inflection point for sales, we would expect to start really in Q3.

當然，我們確實預計在第四季度會花一些錢，但正如我在發言中所說，大部分資金將在第二季和第三季投入。正如里奇所說，我們預計銷售的轉折點將在第三季真正開始。

So does that answer your question?

這回答了你的問題嗎？

Yeah. Thanks.

是的。謝謝。

And Lachlan, just to add to that, I mean, we obviously are doing that very intentionally to front-load the awareness campaign before the summer period, which is really August, September is where you'll see the big peak in epinephrine sales. So we want to make sure we get to all the consumers and make sure they're aware the neffy is available. So the sooner we can do that in the summer period, the better. So we've obviously put a lot of the spend earlier and then we'll taper off after that and get to a steady state.

拉克蘭，我還要補充一點，我們這樣做顯然是為了在夏季之前提前進行宣傳活動，夏季實際上是 8 月和 9 月，腎上腺素的銷量將迎來高峰。因此，我們希望確保我們能夠接觸到所有消費者，並確保他們知道 neffy 已經上市。因此，我們在夏季越早做到這一點就越好。因此，我們顯然在早期投入了大量資金，然後逐漸減少支出並達到穩定狀態。

Okay. Thanks.

好的。謝謝。

Thank you. And with that, ladies and gentlemen, we conclude our Q&A session and program for today. Thank you all for participating. You may now disconnect.

謝謝。女士們、先生們，今天的問答環節和節目到此結束。感謝大家的參與。您現在可以斷開連線。