ARS Pharmaceuticals Inc (SPRY) 2024 Q4 法說會逐字稿

Good day, and welcome to ARS Pharmaceuticals fourth quarter and full year 2024 financial results conference call. (Operator Instructions) As a reminder, this call is being recorded.

大家好，歡迎參加 ARS Pharmaceuticals 2024 年第四季和全年財務業績電話會議。（操作員指示）提醒一下，此通話正在被錄音。

I would now like to turn the call over to Justin Chakma, the Chief Business Officer. Please go ahead.

現在我想將電話轉給首席商務官賈斯汀·查克瑪 (Justin Chakma)。請繼續。

Good morning. With me today are Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma; Eric Karas, our Chief Commercial Officer; and Kathy Scott, our CFO.

早安.今天與我一起出席的還有 ARS Pharma 聯合創始人、總裁兼執行長 Richard Lowenthal；我們的商務長 Eric Karas；以及我們的財務長 Kathy Scott。

Earlier today, we issued a press release outlining our fourth quarter and full year 2021 results along with recent business highlights. You can find this press release on our website at ars-pharma.com.

今天早些時候，我們發布了一份新聞稿，概述了我們 2021 年第四季和全年的業績以及近期的業務亮點。您可以在我們的網站 ars-pharma.com 上找到此新聞稿。

Our call today will proceed as follows. Rich will provide an overview of our corporate progress and key development and insights into the Net launch. Eric will discuss net's ongoing and planned commercialization efforts in the US and our market strategy Kathy will then provide a financial overview, after which we will open the call for questions.

我們今天的電話會議將如下進行。Rich 將概述我們的公司進展和關鍵發展以及對網路發布的見解。Eric 將討論 Net 在美國正在進行和計劃中的商業化努力以及我們的市場策略，Kathy 隨後將提供財務概述，之後我們將開始提問。

Before we begin, please note that today's discussion includes forward-looking statements based on our current expectations. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our earnings release issued today for further details and a discussion of risks.

在我們開始之前，請注意，今天的討論包括基於我們目前預期的前瞻性陳述。這些聲明受風險和不確定性的影響，可能導致實際結果大不相同。請參閱我們今天發布的收益報告以了解更多詳細資訊和風險討論。

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, and thank you to everyone dialing in today.

謝謝你，賈斯汀，也謝謝今天撥電話的所有人。

The past six months have been extremely productive for ARS. Since September, we have successfully launched neffy 2 milligrams in the United States and secured FDA approval for the 1 milligram neffy dose for patients weighing 15 kilograms to less than 30 kilograms. The population of children at this lower weight range that will use neffy 1 milligram represents 23% of the current auto-injector market.

過去六個月對於 ARS 來說是極其富有成果的六個月。自9月以來，我們已在美國成功推出neffy 2毫克，並獲得FDA批准，為體重15公斤至30公斤以下的患者提供1毫克neffy劑量。處於這一較低體重範圍內且將使用 1 毫克 neffy 的兒童群體佔目前自動注射器市場的 23%。

ARS has also made significant strides in payer coverage, with over 51% commercially insured able to get neffy without a prior authorization as of April 1, and we anticipate over 80% with our prior authorization by early this summer with the addition of neffy to the Caremark formulary.

ARS 在付款人覆蓋方面也取得了重大進展，截至 4 月 1 日，超過 51% 的商業保險投保人無需事先授權即可獲得 neffy，並且隨著 neffy 添加到 Caremark 處方集，我們預計到今年夏初，超過 80% 的商業保險投保人將獲得事先授權。

Our commercial execution has established a strong foundation of health care provider awareness for neffy as a compelling alternative to traditional epinephrine auto-injectors, providing patients with a needle-free portable and highly effective options for severe allergic reactions, including anaphylaxis.

我們的商業執行為醫療保健提供者的認識奠定了堅實的基礎，使 neffy 成為傳統腎上腺素自動注射器的有力替代品，為患者提供無針便攜式和高效的治療嚴重過敏反應（包括過敏反應）的選擇。

The US epinephrine market represents a $3 billion in the annual net sales near-term addressable opportunity among 6.5 million patients prescribed epinephrine in the last three years with an additional expansion opportunity among untreated patients of over $7 billion in annual net sales coverage an estimated 20 million patients that have been diagnosed with severe allergic reactions based on claim statement.

美國腎上腺素市場代表著近期可獲得的年淨銷售額為 30 億美元，過去三年共有 650 萬名腎上腺素處方患者，此外，在未經治療的患者中還存在額外的擴展機會，年淨銷售額超過 70 億美元，覆蓋範圍估計為 2000 萬名根據索賠聲明被診斷患有嚴重過敏反應的患者。

However, only 3.2 million patients consistently fill their auto-injector prescriptions, leaving a vast population without protection. Neffy directly addresses this gap by eliminating barriers such as the needle anxiety and portability challenges.

然而，只有 320 萬名患者堅持使用自動注射器注射藥物，導致大量患者無法受到保護。Neffy 透過消除針頭焦慮和便攜性挑戰等障礙直接解決了這一差距。

Just a few weeks ago at the 2025 American Academy of Allergy, Asthma and Immunology Annual Scientific Meeting we showcased nine presentations on the continuously growing body of clinical evidence demonstrating the therapeutic value of neffy to health care providers.

就在幾週前，在 2025 年美國過敏、氣喘和免疫學學會年度科學會議上，我們展示了九場關於不斷增長的臨床證據的報告，證明了 neffy 對醫療保健提供者的治療價值。

Notably, among the presentations at the ACAI meeting, a study in Japanese patients experiencing anaphylaxis symptoms after oral food challenge found that patients receiving that they experienced low symptom scores within 10 minutes compared to traditional intramuscular injection.

值得注意的是，在ACAI會議的報告中，一項針對日本經口食物刺激後出現過敏症狀的患者的研究發現，與傳統的肌肉注射相比，接受該藥物治療的患者在10分鐘內出現的症狀評分較低。

A separate set of clinical studies in China reinforce the bracketed pharmacokinetics and pharmacodynamic profile of Nephew in persons with pure Chinese ethnicity demonstrating its efficacy and safety under a variety of conditions, including self-administration, allergic rhinitis, infectious rhinitis and allergy challenges and repeat dosing.

在中國進行的一組單獨臨床研究強化了 Nephew 在純中國血統人群中的藥物動力學和藥效動力學特徵，證明了其在各種條件下的有效性和安全性，包括自我給藥、過敏性鼻炎、傳染性鼻炎和過敏挑戰以及重複給藥。

An additional analysis confirmed that neffy is safe and achieved effective exposures of epinephrine for patients four years of age and older and weighing 15 kilograms to less than 30 kilograms. I'm proud of these data we presented at the Quad AI meeting as it showcases neffy extensive and rigorous clinical development program.

附加分析證實，neffy 是安全的，並且對於 4 歲及以上、體重 15 公斤至 30 公斤以下的患者實現了有效的腎上腺素暴露。我為我們在 Quad AI 會議上展示的這些數據感到自豪，因為它展示了 neffy 廣泛而嚴格的臨床開發計劃。

Neffy remains the only approved product to have generated anaphylaxis efficacy data in a clinical study to have met the bracketing criteria established by FDA for approval of all key pharmacokinetic parameters to ensure safety and efficacy and to have data demonstrating that it is well tolerated in children down to 15 kilograms body weight to account for almost half of the patients prescribed epinephrine.

Neffy 仍然是唯一獲得批准的產品，它在臨床研究中產生了過敏反應功效數據，滿足 FDA 為批准所有關鍵藥物動力學參數而製定的括號標準，以確保安全性和有效性，並且有數據證明它對體重低至 15 公斤的兒童具有良好的耐受性，佔處方腎上腺素患者的近一半。

This and other extensive clinical data we have previously presented on neffy's profile has now been supported by the growing real-world data of treating anaphylactic reactions from our neffy Experience Program.

我們先前在 neffy 的資料中展示的這一數據和其他大量臨床數據現在已經得到了來自我們的 neffy 體驗計劃的越來越多的治療過敏反應的真實世界數據的支持。

The data from the neffy Experience Program to date is numerically better than that historically reported with epinephrine injections. We plan to share additional details of the survey of our neffy Experience Program once we have completed the survey and plan to repeat this several times during the program as it progresses with over 2,500 clinicians having neffy for oral food challenges and immunotherapy treatment.

迄今為止，neffy 體驗計劃的數據在數值上優於歷史上報告的腎上腺素注射數據。我們計劃在完成調查後分享有關 neffy 體驗計劃調查的更多詳細信息，併計劃在計劃進行過程中重複此調查幾次，屆時將有超過 2,500 名臨床醫生使用 neffy 進行口服食物挑戰和免疫療法治療。

At AAAAI, hundreds of physicians shared with us many of their positive success stories of treating patients with neffy, including cases where patients had been rescued by Nephew from even having very severe anaphylactic reactions and being unconscious.

在 AAAAI，數百名醫生與我們分享了他們使用 neffy 治療患者的許多積極成功案例，其中包括患者在出現非常嚴重的過敏反應和昏迷狀態時被 Nephew 救活的案例。

Physicians are clearly and enthusiastically communicating to us that they believe that neffy represents a new standard of care. We have established a strong initial commercial trajectory in the US to ultimately deliver on this expectation and establish neffy as the new standard of care.

醫生們清楚而熱情地向我們傳達了他們相信 neffy 代表著一種新的護理標準。我們已經在美國建立了強大的初始商業軌跡，最終實現這一期望並將 neffy 確立為新的護理標準。

Since the initial launch in September of 2024, neffy generated $7.3 million in net product revenue in the United States, reflecting a strong early adoption since it became available in the fourth quarter and strong breadth of early prescribing with thousands of health care providers prescribing neffy reflecting the allergy community's confidence in neffy as an alternative treatment.

自 2024 年 9 月首次推出以來，neffy 在美國創造了 730 萬美元的淨產品收入，這反映了自第四季度上市以來的強勁早期採用率和早期處方廣度，數千家醫療保健提供者開出了 neffy，反映了過敏社區對 neffy 作為替代療法的信心。

That said, as you can see in the IQVIA prescription data, we are still on the early part of the S curve of what we anticipate to go into a multibillion-dollar blockbuster peak sales trajectory. We anticipate a significant inflection in both the depth as well as the breadth of health care provider prescribing later this year as the headwinds from the need for prior authorization requests diminish.

話雖如此，正如您在 IQVIA 處方數據中所看到的，我們仍然處於 S 曲線的早期階段，我們預計將進入數十億美元的重磅高峰銷售軌跡。我們預計，隨著事先授權請求需求帶來的阻力逐漸減小，今年稍後醫療保健提供者處方的深度和廣度都將發生顯著變化。

Healthcare providers consistently tell us that the current levels of neffy prescribing represent only a fraction of their intended use of the product in the future. In fact, one leading allergist stated that he intends to switch all of his 4,000 patients, but our data shows that this doctor has only prescribed to about 1% of their patients to date given the need for these prior authorizations to get approval.

醫療保健提供者一直告訴我們，目前的 neffy 處方水平僅代表未來該產品預期用途的一小部分。事實上，一位著名的過敏症專家表示，他打算為所有 4,000 名患者更換藥物，但我們的數據顯示，由於需要事先獲得授權才能獲得批准，這位醫生迄今為止只為大約 1% 的患者開了處方。

A key learning in the neffy launch is the unique administrative barrier that prior authorization is posed for neffy due to the large volume of epinephrine eligible patients as well as the acute nature of this disease. This results in the need for a very large number of prior authorizations to get a significant revenue given each prior authorization translates to an average of 1.3 prescriptions per patient to date.

neffy 上市過程中的一個關鍵經驗是，由於符合腎上腺素治療條件的患者數量眾多，且該疾病性質急性，neffy 面臨著獨特的行政障礙，需要事先授權。這意味著需要大量的事先授權才能獲得可觀的收入，因為迄今為止，每個事先授權相當於每位患者平均 1.3 張處方。

As a result, health care providers only have bandwidth to prescribe very selectively due to the cumulative time required to prepare prior authorizations, even with simplified forms and ARS facilitation through BLINKRx.

因此，即使使用簡化的表格並透過 BLINKRx 提供 ARS 便利，由於準備事先授權所需的累積時間，醫療保健提供者也只能非常有選擇性地開處方。

Based on the feedback from hundreds of prescribers, including most recently at the AAAAI meeting, we expect to see a tipping point in the neffy trajectory as we obtain our payer coverage goals early this summer and the prescribing more seamless for physicians.

根據數百名處方醫師的回饋，包括最近在 AAAAI 會議上的回饋，我們預計隨著我們在今年夏初實現付款人覆蓋目標以及醫生的處方更加無縫，neffy 軌跡將出現一個轉折點。

Our payer engagement strategy has already yielded multiple favorable coverage decisions, including a set the group purchasing organization for Express Scripts, one of the three largest pharmacy benefit managers in the United States who put neffy on formulary within 10 weeks of launch.

我們的付款人參與策略已經產生了多個有利的核保決策，其中包括為 Express Scripts 設立的團體採購組織，Express Scripts 是美國三大藥品福利管理公司之一，在推出 neffy 後 10 週內就將其列入處方集。

In the last month, we also have signed contracts and provided patients with unrestricted access to neffy with two other group purchasing organizations, MSR and zinc at terms that preserve are greater than 50% gross to net yield.

上個月，我們還與另外兩個集團採購組織 MSR 和鋅簽訂了合同，並為患者提供不受限制的 neffy 使用權，條款規定總收益與淨收益之比應超過 50%。

MSR signed an agreement in February, adding neffy to their formulary, which now gives patients who have OptumRx access without any restrictions. As of April 1, UnitedHealthcare will also add three to their formulary with unrestricted coverage under the MSR agreement.

MSR 於二月份簽署了一項協議，將 neffy 添加到其處方集中，現在擁有 OptumRx 的患者可以不受任何限制地使用 neffy。自 4 月 1 日起，聯合健康保險還將根據 MSR 協議在其處方集中增加三種不受限制的保險。

Just the past few days, we also obtained agreement and coverage with Zinc, which provides access to the largest payer in the United States, CVS Caremark as well as Anthem, Aetna and several other insurers. We anticipate being on formulary for CVS Caremark, Anthem, Aetna, and others by July 1 in time for the summer peak prescribing season for children. Therefore, we remain on track for 80% unrestricted commercial coverage by the summer of this year.

就在過去的幾天裡，我們還與 Zinc 達成了協議並獲得了保險，該公司為美國最大的付款人 CVS Caremark 以及 Anthem、Aetna 和其他幾家保險公司提供了保險。我們預計在 7 月 1 日之前將藥品列入 CVS Caremark、Anthem、Aetna 和其他公司的處方集，以趕上夏季兒童用藥高峰期。因此，我們仍有望在今年夏天實現 80% 不受限制的商業覆蓋率。

We have also made progress on Medicaid with bellwether states such as Texas, Alabama and Montana adding Nephew to their formularies without prior authorization and other states are expected to follow suit in the coming months leading into the summer prescribing season for children.

我們在醫療補助方面也取得了進展，德克薩斯州、阿拉巴馬州和蒙大拿州等領頭州無需事先授權就將 Nephew 添加到了他們的處方集中，預計其他州也將在未來幾個月內效仿，進入夏季兒童處方季節。

By this summer, we anticipate physicians to freely start writing neffy for their patients without being deterred by the administrative workload of prior authorizations. This will be in time for the back-to-school season driven by the pediatric population and will also be supported by the fact that we will have 1 milligram neffy in the marketplace by May 2025, which represents 23% of all prescriptions, as mentioned earlier.

到今年夏天，我們預計醫生可以自由地開始為他們的病人開 neffy 處方，而不受事先授權的行政工作量所阻礙。這將趕上由兒科人群推動的返校季節，並且也將得到以下事實的支持：到 2025 年 5 月，我們將在市場上推出 1 毫克的 neffy，佔所有處方的 23%，如前所述。

And having ended this year with over $314 million in cash or cash equivalents, we are in a strong financial position to accelerate adaptation and awareness during the back-to-school season, including an extensive direct-to-consumer campaign, we anticipate launching in May of 2025.

今年年底，我們擁有超過 3.14 億美元的現金或現金等價物，財務狀況良好，可以在返校季加快適應和提高認識，包括一項廣泛的直接面向消費者的活動，我們預計將於 2025 年 5 月啟動。

In parallel, we are also on track to have a global commercialization footprint with neffy within one year from now. As a reminder, Euro neffy, the equivalent of neffy in Europe, is approved in the European Union.

同時，我們也預計在一年內讓 neffy 實現全球商業化。提醒一下，與歐洲 neffy 等同的 Euro neffy 已在歐盟獲得批准。

Our UK regulatory submission is under review with a decision expected by May 2025 and our partner, ALK-Abello is preparing for commercial launches in Germany and UK by this summer. Regulatory submissions are also completed in Canada, China, Japan and Australia, with decisions in Canada, China and Japan anticipated by year-end 2025. As we look ahead, physicians and patients demand is clear for neffy.

我們的英國監管提交文件正在接受審查，預計將於 2025 年 5 月做出決定，我們的合作夥伴 ALK-Abello 正準備於今年夏天在德國和英國進行商業發布。加拿大、中國、日本和澳洲的監管提交也已完成，預計加拿大、中國和日本將於 2025 年底做出決定。展望未來，醫生和患者對 neffy 的需求是明確的。

We are also getting favorable payer formulary coverage, which is now just a function of time with the three major GPOs signing agreements that are favorable and give us a 50% gross to net or better.

我們還獲得了有利的付款人處方集覆蓋，這只是時間的函數，三大 GPO 簽署了有利的協議，為我們提供 50% 或更高的毛利率。

We are also accelerating our marketing and investments in direct-to-consumer advertising prior to the back-to-school peak prescribing season. We expect to see significantly broader and deeper adaptation in neffy across the board through conversion of the existing epinephrine users reactivation of patients who previously avoided treatment due to their fear of injection and bringing neffy to those who didn't have a prescription or diagnosis in the past.

在返校高峰處方季節到來之前，我們還將加速行銷和直接面向消費者的廣告投資。我們期望透過轉化現有的腎上腺素使用者、重新激活那些先前因害怕注射而避免接受治療的患者，並將 neffy 帶給那些過去沒有處方或診斷的患者，看到 neffy 在各個方面得到更廣泛和更深入的適應。

Let me turn the call over to Eric to walk through our commercial highlights and plans for increasing adoption and use of neffy in 2025.

讓我將電話轉給 Eric，讓他介紹一下我們的商業亮點以及 2025 年增加 neffy 的採用和使用的計劃。

Good morning, and thank you, Rich. As we've laid out previously, our net commercial strategy is focused on three core areas: physician education and engagement to drive neffy adoption and market share, peer coverage to ensure affordability and access to neffy and patient awareness and education to encourage adoption and prompt patients to ask their health care provider for neffy.

早安，謝謝你，Rich。正如我們之前所述，我們的網路商業策略專注於三個核心領域：醫生教育和參與，以推動 neffy 的採用和市場份額；同儕覆蓋，以確保 neffy 的可負擔性和可及性；患者意識和教育，以鼓勵採用並促使患者向其醫療保健提供者尋求 neffy。

Our team is executing very well against all three of these. To date, our sales team has directly engaged with approximately 9,000 health care providers. Additionally, more than 4,000 health care providers have submitted neffy prescriptions through BlinkRx by neffyconnect.

我們的團隊在這三個方面都表現得非常出色。迄今為止，我們的銷售團隊已與約 9,000 家醫療保健提供者直接合作。此外，已有超過 4,000 家醫療保健提供者透過 neffyconnect 的 BlinkRx 提交了 neffy 處方。

Importantly, approximately 81% of these prescriptions were submitted by physicians in the highest decile of allergists. These are physicians who represent the highest volume prescriptions in the US. At the recent AAAAI meeting, we met with over 1,000 physicians and the feedback across the spectrum of stakeholders continues to reinforce the enthusiasm for a needle-free epinephrine treatment and the growing demand for neffy.

重要的是，這些處方中約有 81% 是由過敏症專家中最高水準的醫生提交的。這些醫生是美國開立處方量最高的醫生。在最近的 AAAAI 會議上，我們會見了 1,000 多名醫生，各利益相關者的回饋繼續增強了人們對無針腎上腺素治療的熱情和對 neffy 日益增長的需求。

Among the physicians that the teams at the conference, the feedback regarding the product was overwhelmingly positive. Many HCPs who have used neffy in a clinical setting as part of the experience program shared their experiences. One particular influential physician who is a thought leader amongst his peers had his first experience with neffy just two weeks before the conference.

在參加會議的醫生團隊中，對該產品的回饋非常正面。許多在體驗計劃中在臨床環境中使用過 neffy 的 HCP 分享了他們的經驗。一位特別有影響力的醫生，他是同行中的思想領袖，在會議召開前兩週首次體驗了 neffy。

He was so impressed with the response, which appeared within a minute that he shared his experience with his colleagues and nursing team. Allergists have reported great real-world success with response rates similar to or even better than those historically reported with epinephrine injection products.

他對一分鐘內出現的反應印象深刻，並與同事和護理團隊分享了他的經驗。過敏症專家報告了現實世界中的巨大成功，其反應率與歷史上報告的腎上腺素注射產品的反應率相似甚至更好。

As of today, approximately 2,500 allergists have enrolled in our neffy Experience Program, and as shared -- it allows for a hands-on clinical use and real-world validation of the product. This participation represents over 80% of the health care professionals conducting allergy-challenged studies, reflecting a strong interest in neffy.

截至今天，大約有 2,500 名過敏症專家參加了我們的 neffy 體驗計劃，並且正如所分享的 - 它允許實際臨床使用和產品的實際驗證。參與人數佔進行過敏症研究的醫療保健專業人士的 80% 以上，反映出人們對 neffy 的濃厚興趣。

Our commercial team is actively sharing this information with both net experience participants and health care professionals more broadly, which reinforces their confidence in neffy's clinical profile backed by real-world response data.

我們的商業團隊正在積極地與網路體驗參與者和醫療保健專業人員更廣泛地分享這些信息，這增強了他們對 neffy 臨床概況的信心，並得到了真實世界反應數據的支持。

We have observed strong adoption by payers with positive coverage decisions from major organizations such as Express Scripts, Cigna, Optum, Navitus Health and TRICARE. The coverage enhances access to neffy for millions of commercially insured patients across the nation. Furthermore, starting April 1, UnitedHealthcare will include neffy as a covered treatment without a prior authorization.

我們觀察到付款方的大力採用，並獲得了 Express Scripts、Cigna、Optum、Navitus Health 和 TRICARE 等主要組織的積極承保決定。該保險提高了全國數百萬商業保險患者獲得 neffy 服務的機會。此外，從 4 月 1 日起，UnitedHealthcare 將 neffy 納入無需事先授權的承保治療範圍。

In addition, all three group purchasing organizations have signed contracts with us, Athens in late Q4 of last year and zinc and MSR in the last few weeks. And we expect downstream payers of these GPOs to adopt the negotiated terms and add neffy to the formularies with unrestricted access.

此外，所有三個集團採購組織都與我們簽署了合同，雅典於去年第四季度末簽署，鋅和 MSR 於過去幾週簽署。我們期望這些 GPO 的下游付款人採用協商條款，並將 neffy 新增至具有不受限制存取權限的處方集中。

Payers recognize the added value that neffy offers by lowering barriers to prompt epinephrine use, leading to better outcomes for patients and reduce health care costs. Our goal is for neffy to achieve more than 60% commercial coverage by the end of the first quarter.

付款人認識到 neffy 透過降低促使使用腎上腺素的障礙所提供的附加價值，從而為患者帶來更好的治療結果並降低醫療保健成本。我們的目標是到第一季末，neffy 的商業覆蓋率達到 60% 以上。

Given our current position, we are confident in our ability to reach this target. We are actively engaging in discussions and contract negotiations with additional key payers and expect to achieve 80% commercial coverage by the early part of the third quarter.

鑑於我們目前的狀況，我們有信心能夠實現這一目標。我們正在積極與其他主要付款人進行討論和合約談判，預計到第三季初將實現 80% 的商業覆蓋率。

As commercial coverage increases, the product acquisition process is streamlined, allowing doctors to more easily send prescriptions directly to retail pharmacies, such as CVS and Walgreens. For patients with commercial insurance, our co-pay assistance program has made neffy more affordable.

隨著商業覆蓋範圍的擴大，產品採購流程得到簡化，醫生可以更輕鬆地將處方直接發送到零售藥局，例如 CVS 和 Walgreens。對於擁有商業保險的患者，我們的共同支付援助計劃使 neffy 更加實惠。

Most commercial patients only pay $25 for each prescription, which is lower than the average co-pay of $40 for a generic auto-injector. Our co-pay support is automatically applied at the point of sale, ensuring that neffy is accessible to more patients.

大多數商業患者每張處方只需支付 25 美元，低於通用自動注射器 40 美元的平均共同支付額。我們的共同支付支援在銷售點自動應用，確保更多患者可以使用 neffy。

Switching gears. We are also proud of our neffy in schools program, which provides K-12 schools with two cartons or four single-use doses of neffy at no cost. This initiative aims to promote widespread adoption of the product in schools nationwide.

換擋。我們也為我們的學校計劃感到自豪，該計劃免費為 K-12 學校提供兩盒或四劑一次性使用的 neffy。此項措施旨在推動該產品在全國學校的廣泛採用。

To date, more than 5,000 nurses have participated in our educational sessions and are now advocates for an neffy. We greatly appreciate the collaboration with school nurses who play a crucial role in safeguarding children by administering this easy-to-use needle-free epinephrine device in emergencies.

迄今為止，已有 5,000 多名護理師參加了我們的教育課程，現在已成為 neffy 的倡導者。我們非常感謝與學校護士的合作，他們在緊急情況下使用這種易於使用的無針腎上腺素裝置在保護兒童方面發揮著至關重要的作用。

As we look ahead, we are planning a large-scale direct-to-consumer advertising campaign starting in May. This is time for the peak prescribing season during the summer. This campaign will include connected television platforms such as Hulu, Netflix and Prime as well as linear TV focused on news and sports channels.

展望未來，我們計劃從五月開始進行大規模的直接面向消費者的廣告活動。此時正是夏季處方高峰期。活動將包括 Hulu、Netflix 和 Prime 等連網電視平台以及專注於新聞和體育頻道的線性電視。

In addition, we will utilize print and social media incorporating influencer partnerships with a combination of broad and targeting advertising strategies. This initiative is crucial because our market research indicates that when a patient requests neffy, physicians will prescribe it, provided there are no market access barriers.

此外，我們將利用印刷媒體和社交媒體，結合有影響力的合作夥伴關係以及廣泛和有針對性的廣告策略。這項措施至關重要，因為我們的市場研究表明，當患者要求使用 neffy 時，只要不存在市場准入障礙，醫生就會開立這種藥物。

We also recognize that the epinephrine market has been highly responsive to promotional efforts in the past, and we have seen no meaningful promotion in the last decade. We are planning additional near-term commercial initiatives specifically aimed at the pediatric population, targeting both health care providers and caregivers. We plan to share more details about these initiatives in the coming weeks.

我們也意識到，腎上腺素市場對過去的促銷活動反應非常積極，但在過去十年中我們沒有看到任何有意義的促銷活動。我們正在計劃近期推出更多商業計劃，專門針對兒科人群，目標客戶包括醫療保健提供者和護理人員。我們計劃在未來幾週分享有關這些舉措的更多細節。

The pediatric population significantly contributes to the summer peak in prescriptions observed in the market as schools prepare to reopen. We believe we are well positioned to take advantage of this seasonal trend, especially since early adopters of neffy are parents with children who are affected.

隨著學校準備重新開學，兒科人口對市場上處方藥的夏季高峰做出了重大貢獻。我們相信，我們已做好準備，充分利用這一季節性趨勢，尤其是因為 neffy 的早期採用者是孩子受到影響的父母。

The recent approval of the 1-milligram dose will allow us to access the entire school age population. We also plan to continue collaborating with our advocacy partners running PSA campaigns as well as other institutional partners to create a total surround sound environment for neffy. Finally, as the year progresses, we'll evaluate further expansion of our sales team by early 2026, and to maximize health care provider engagement and drive market share.

最近批准的 1 毫克劑量將使我們能夠覆蓋整個學齡人口。我們也計劃繼續與進行 PSA 活動的宣傳夥伴以及其他機構夥伴合作，為 neffy 創造一個全方位的環繞聲環境。最後，隨著時間的推移，我們將評估在 2026 年初之前進一步擴大我們的銷售團隊，並最大限度地提高醫療保健提供者的參與度並提高市場份額。

After spending several months on the front lines with our sales team and meeting with hundreds of prescribers, it has become clear that neffy has a compelling clinical profile that resonates with both physicians and patients. This has been further validated by the successful treatment of patients with allergic reactions as demonstrated in our neffy Experience Program.

在與我們的銷售團隊一起在第一線工作了幾個月並與數百名處方醫生會面後，很明顯，neffy 具有引人注目的臨床特徵，能夠引起醫生和患者的共鳴。我們的 neffy 體驗計劃對過敏反應患者的成功治療進一步證實了這一點。

All indications show that physicians are eager to prescribe neffy more frequently, and we understand the steps needed to remove the obstacles they face. We are excited to unlock the demand for neffy in the coming months by ensuring a more seamless insurance experience and driving patient demand through our comprehensive DTC campaign and our sales and marketing efforts.

所有跡像都表明，醫生渴望更頻繁地開出 neffy，我們也了解消除他們面臨的障礙所需的步驟。我們很高興能夠在未來幾個月內透過全面的 DTC 活動以及銷售和行銷努力，確保更無縫的保險體驗並推動患者需求，從而釋放對 neffy 的需求。

Let me now pass the call over to Kathy to talk through our financials.

現在，讓我將電話轉給凱西，討論我們的財務狀況。

Thanks, Eric. We reported our Q4 and full year 2024 financial results in a press release this morning, and I'll walk through some of the highlights.

謝謝，埃里克。我們今天早上在新聞稿中報告了我們的第四季度和 2024 年全年財務業績，我將介紹其中的一些亮點。

In terms of sales, we're proud to have recorded $6.7 million in net sales for the fourth quarter of 2024 and $7.3 million for the full year 2024 since our launch in late September. Of note, these revenues are slightly higher than the preliminary numbers that we announced mid-January.

在銷售方面，自 9 月底推出以來，我們很自豪地記錄了 2024 年第四季 670 萬美元的淨銷售額和 2024 年全年 730 萬美元的淨銷售額。值得注意的是，這些收入略高於我們一月中旬公佈的初步數字。

Before turning to our revenues, I'll take a minute to explain how we're treating the cash proceeds from our ALK licensing agreement that was signed in November 2024. As a reminder, we received a nonrefundable upfront cash payment of $145 million from ALK.

在談到我們的收入之前，我想花一點時間解釋一下我們如何處理 2024 年 11 月簽署的 ALK 授權協議的現金收益。提醒一下，我們從 ALK 收到了 1.45 億美元的不可退還的預付現金。

In Q4, only $73.5 million of that payment was included in our revenues. The remaining $71.5 million is treated as a liability on the balance sheet due to GAAP accounting treatment. Specifically, $69.4 million is treated as a financing liability and $2.1 million is treated as a contract liability for future performance obligations.

在第四季度，該付款中只有 7,350 萬美元計入我們的收入。根據 GAAP 會計處理，剩餘的 7,150 萬美元在資產負債表上被視為負債。具體而言，6,940 萬美元被視為融資負債，210 萬美元被視為未來履約義務的合約負債。

This GAAP accounting treatment is because of a specific term of our licensing agreement that we built in to maintain strategic optionality for the future. The agreement ensures that ARS has the option to repurchase rights for certain regions partnered out to ALK, which results in our not being able to account for a portion of the cash proceeds as revenue.

這種 GAAP 會計處理是因為我們建立了許可協議的特定條款，以保持未來的策略選擇性。該協議確保 ARS 有權選擇回購與 ALK 合作的某些地區的權利，這導致我們無法將部分現金收益記為收入。

So while the business and economic intent is that of a licensing agreement due to the open-ended flexibility of the reacquisition language, GAAP treats cash flows from these certain territories as a financing agreement that shows up on the balance sheet, impacting our reported revenue figures.

因此，雖然由於重新收購語言的開放式靈活性，其商業和經濟意圖是許可協議，但 GAAP 將來自這些特定地區的現金流量視為出現在資產負債表上的融資協議，從而影響我們報告的收入數字。

To reiterate, there is no impact on the amount of the nonrefundable cash proceeds received, and we have sole discretion in how they are used.

需要重申的是，這不會對收到的不可退還現金收益的金額產生任何影響，並且我們擁有對其如何使用的唯一決定權。

Going forward, none of the financing liability from the ALK agreement that appears on the balance sheet as of December 31, 2024, will be included in revenue until the expiration of the ALK agreement. We expect to receive $5 million in cash proceeds from milestones under the ALK agreements in each of Q2 and Q4 2025. Approximately half of each $5 million payment will be recognized as GAAP revenue.

展望未來，截至 2024 年 12 月 31 日資產負債表上出現的 ALK 協議的任何融資負債均不計入收入，直至 ALK 協議到期。我們預計 2025 年第二季和第四季將分別從 ALK 協議下的里程碑中獲得 500 萬美元的現金收益。每 500 萬美元付款中約有一半將被確認為 GAAP 收入。

The other half would not be recognized as GAAP revenue, but will be added to the financing liability on the balance sheet. Future royalty payments from ALK would be recognized as GAAP revenue if they are related to the territories that are not subject to the repurchase right. Royalty payments related to territories that are subject to the repurchase right would be capitalized and added to the financing liability on the balance sheet.

另一半不會被確認為 GAAP 收入，但會被加到資產負債表的融資負債中。如果 ALK 未來支付的特許權使用費與不受回購權約束的地區有關，則將被確認為 GAAP 收入。與受回購權約束的地區相關的特許權使用費將被資本化並添加到資產負債表的融資負債中。

To summarize our 2024 revenues. Total revenue for the fourth quarter of 2024 was $86.6 million, which included $6.7 million in net product revenue from NAV sales in the United States, $73.5 million in collaboration revenue from ALK, $6 million in collaboration revenue from our licensing partner in Japan and $0.4 million in revenue from supply agreements.

總結一下我們 2024 年的收入。2024 年第四季的總收入為 8,660 萬美元，其中包括來自美國 NAV 銷售的 670 萬美元淨產品收入、來自 ALK 的 7,350 萬美元合作收入、來自我們在日本的許可合作夥伴的 600 萬美元合作收入以及來自供應協議的 40 萬美元收入。

Full year 2024 revenue totaled $89.1 million reflecting $7.3 million in neffy sales in the US, $81.5 million in collaboration revenue and $0.4 million from supply agreements. The Q4 and full year 2024 revenues do not include the $71.5 million cash proceeds received from ALK that are required by GAAP to be recorded as a liability on the balance sheet.

2024 年全年總收入為 8,910 萬美元，其中包括美國 neffy 銷售額 730 萬美元、合作收入 8,150 萬美元以及供應協議收入 40 萬美元。2024 年第四季和全年收入不包括從 ALK 收到的 7,150 萬美元現金收益，根據 GAAP 要求，這些收益需在資產負債表中記錄為負債。

Turning to our expenses. R&D expenses for the fourth quarter and full year 2024 were $3 million and $19.6 million, respectively. These costs were primarily associated with the manufacturing of neffy to support our US commercial launch, along with certain other product development costs and personnel-related expenses.

談到我們的開支。2024年第四季和全年的研發費用分別為300萬美元和1,960萬美元。這些成本主要與製造 neffy 以支持我們在美國的商業發布有關，以及某些其他產品開發成本和人員相關費用。

Our SG&A expenses for the fourth quarter and full year 2024 were $35.5 million and $71.7 million, respectively. These primarily reflect marketing expenses and personnel-related costs associated with the commercial launch of neffy as well as general operating expenses.

我們 2024 年第四季及全年的銷售、一般及行政費用分別為 3,550 萬美元及 7,170 萬美元。這些主要反映了與 neffy 商業發布相關的行銷費用和人員相關成本以及一般營運費用。

We had net income of $49.9 million or $0.51 per share basic and $0.48 per share diluted for the fourth quarter. Net income was $8 million or $0.08 per share basic and diluted for the full year 2024.

第四季我們的淨收入為 4,990 萬美元，即每股基本收入 0.51 美元，每股攤薄收入為 0.48 美元。2024 年全年淨收入為 800 萬美元，即每股基本收入和攤薄收入各為 0.08 美元。

In terms of our balance sheet and cash runway, we ended the year with $314 million in cash, cash equivalents and short-term investments. At the time of FDA approval of neffy 2-milligram in August 2024, we guided to an operating runway of at least three years, which budgeted in an upfront fee of about $50 million for an ex US partnership.

就我們的資產負債表和現金流而言，我們截至年底的現金、現金等價物和短期投資為 3.14 億美元。在 2024 年 8 月 FDA 批准 neffy 2 毫克時，我們指導了至少三年的營運時間，其中預算了約 5000 萬美元的前期費用，用於前美國合作夥伴。

The ALK licensing agreement provide us with a significantly greater cash infusion of $145 million upfront and an additional $10 million in near-term regulatory and launch milestones expected to be attained in mid- to late 2025.

ALK 授權協議為我們提供了一筆數額龐大的現金注入，即 1.45 億美元的預付現金和 1000 萬美元的短期監管和發布里程碑資金，預計將在 2025 年中後期實現。

As such, the combination of the capital brought in from our ALK deal along with our earlier-than-anticipated success in obtaining favorable coverage decisions from US payers has given us a lot of flexibility to further invest in the commercialization of neffy, while maintaining a strong balance sheet.

因此，我們從 ALK 交易中獲得的資本，加上我們比預期更早從美國付款人那裡獲得有利的承保決定，為我們提供了很大的靈活性，可以進一步投資 neffy 的商業化，同時保持強勁的資產負債表。

Looking ahead, as Eric noted, we plan to accelerate our DTC investment beginning in May in order to take advantage of the back-to-school seasonality. We are projecting a DTC campaign spend of between $40 million and $50 million in 2025. In parallel, we are working to ensure availability of the 1-milligram neffy dose for children four years or older starting in May.

展望未來，正如 Eric 所說，我們計劃從 5 月開始加速 DTC 投資，以利用返校旺季的優勢。我們預計 2025 年 DTC 行銷活動的支出將在 4,000 萬至 5,000 萬美元之間。同時，我們正在努力確保從五月開始為四歲或以上的兒童提供 1 毫克劑量的 neffy。

With this in mind, we anticipate operating expenses, excluding both cost of goods sold and stock-based compensation will be approximately $200 million to $210 million for the full year 2021. With this forecast, we still expect to maintain a runway of at least three years based on our current operating plan.

考慮到這一點，我們預計 2021 年全年的營運費用（不包括銷售成本和股票薪酬）將約為 2 億至 2.1 億美元。根據這項預測，我們仍希望根據目前的營運計畫維持至少三年的跑道。

I'll hand the call over to Rich now to finish up.

我現在會把電話交給 Rich 來完成。

2024 has set up 2025 to be a pivotal year of commercial execution for neffy. Our primary focus is accelerating adoption of neffy and expanding global market access and advancing our intranasal epinephrine technology with the plan to start Phase 1 in urticaria as well as our allergy challenge clinic registry study in the next few weeks.

2024 年已確定 2025 年將成為 neffy 商業執行的關鍵一年。我們的主要重點是加速 neffy 的採用和擴大全球市場准入，並推進我們的鼻內腎上腺素技術，計劃在未來幾週內啟動蕁麻疹的第一階段以及我們的過敏挑戰診所註冊研究。

The early enthusiasm from physicians, payers and patients reinforces our confidence in neffy's potential to become a new standard of care in emergency allergy treatment. I'd like to thank the entire ARS team for their dedication in making this launch a success. We look forward to continued momentum in 2025 and beyond.

醫生、付款人和患者的早期熱情增強了我們對 neffy 成為緊急過敏治療新護理標準的潛力的信心。我要感謝整個 ARS 團隊為此次發布會的成功所做的貢獻。我們期待 2025 年及以後繼續保持這一勢頭。

With that, let's open up the call for questions.

現在，讓我們開始提問。

(Operator Instructions) Ryan Deschner, Raymond James.

（操作員指示）Ryan Deschner、Raymond James。

Congrats on the progress. I think you mentioned that neffy 1 milligram will be available starting in May. A lot of KOLs we've spoken to has said this is the big source of demand even currently. How are you looking at the ramp for this format relative to what we've seen with the 2 mg product? And then I have a follow-up.

恭喜你取得進展。我想您提到過 neffy 1 毫克將於 5 月開始上市。我們採訪過的許多 KOL 都表示，這在目前也是最大的需求來源。與我們所見的 2 毫克產品相比，您如何看待這種格式的成長？然後我有一個後續問題。

Yes. We believe it's additive. It's about 23% of the market. However, it's probably more than that for the impact on the sales ramp of neffy as we discuss the the adoption we're seeing right now is heavily weighted towards children. So obviously, adding the younger children, which obviously, parents have more of an issue with injecting is actually -- should be very beneficial.

是的。我們相信它具有附加作用。約佔市場佔有率的23%。然而，對於 neffy 銷售成長的影響可能不止於此，因為我們現在看到的採用者主要是兒童。因此，顯然，對於年齡較小的孩子來說，他們的父母對注射的擔憂更大，這實際上應該是非常有益的。

And as we said, we expect it to be weighted -- and in 2024, it was 23% of the prescriptions for epinephrine injection. So we think the 23% will have a significant impact on our sales ramp -- or sorry, the 1 milligram, excuse me, the 23% would have a significant impact.

正如我們所說，我們預計它會有所加權——到 2024 年，它將佔腎上腺素注射處方的 23%。因此，我們認為 23% 將對我們的銷售成長產生重大影響 - 或者抱歉，1 毫克，對不起，23% 將產生重大影響。

Got it. And then just one more. I wondering if you could give us any more detail on the progress towards the 80% access goal, which I think was more toward the end of the third quarter. It sounds like it's evolving. And what proportion of neffy sales do you expect to come from public programs like Medicaid.

知道了。然後再來一個。我想知道您是否可以向我們提供有關實現 80% 訪問率目標的進展情況的更多詳細信息，我認為這是在第三季末完成的。聽起來它正在進化。您預計 neffy 銷售額中有多少比例來自醫療補助 (Medicaid) 等公共項目？

Yes. And I'll speak a little bit to that end and then Eric, if there's anything I missed you can add in. So at this point, we're at about -- as of April 1, so UnitedHealthcare came into agreement with us, and we'll put it on unrestricted access on April -- so as of April 1, we'll be at about 51% of commercial patients will have access without prior authorization.

是的。我就講一點這個話題，然後艾瑞克，如果我有什麼遺漏的話你可以補充。因此，目前，我們大約處於 - 截至 4 月 1 日，聯合健康保險與我們達成協議，我們將在 4 月將其置於不受限制的訪問狀態 - 因此截至 4 月 1 日，我們將有大約 51％ 的商業患者無需事先授權即可訪問。

Now it's a little over 60% total -- but we actually focus on the ones that don't need the prior authorization because that's the -- what we're realizing is the major barrier to prescribing neffy for a lot of physicians, even those that are very favorable, they honestly tell us they only have so many hours in a day and weekends to write prior authorization. So it is a big headwind.

現在總數略高於 60% - 但我們實際上關注的是那些不需要事先授權的，因為那是 - 我們意識到這是許多醫生開具 Neffy 處方的主要障礙，即使是那些非常有利的醫生，他們也會誠實地告訴我們，他們每天只有這麼多時間和周末來寫事先授權。所以這是一個巨大的阻力。

With that also said, we just signed an agreement really just within the last week with zinc. Zinc represents Caremark, Anthem and a number of other insurers, which is more than 25% of the commercially insured market.

話雖如此，我們上週剛剛與鋅簽署了一項協議。Zinc 代表 Caremark、Anthem 和其他一些保險公司，佔商業保險市場的 25% 以上。

Unfortunately, for whatever reason, I can't tell you, but Caremark typically only puts things on formulary either January 1 or July 1. So we do currently expect them to put neffy on formulary by July 1. They do make exceptions. It could go sooner, but we don't know that yet.

不幸的是，無論出於什麼原因，我都無法告訴您，但 Caremark 通常只會在 1 月 1 日或 7 月 1 日將藥品列入處方集。因此，我們目前確實希望他們能在 7 月 1 日之前將 neffy 納入處方集。他們確實會做出例外。它可能會更早，但我們還不知道。

If Caremark goes on formulary July 1, we also expect that Aetna and Anthem to be on formulary and by formulary mean unrestricted access, right? So no prior authorization required because they're already approving prior authorizations fairly readily.

如果 Caremark 於 7 月 1 日進入處方集，我們也希望 Aetna 和 Anthem 也能進入處方集，而處方集意味著不受限制的訪問，對嗎？因此不需要事先授權，因為他們已經相當容易地批准事先授權。

But we do expect them to have unrestricted access by July 1 or sooner. So that would bring us very close to that 80% mark. Certainly, if you count all coverage, but even just counting unrestricted access, I think we'd be close to the 80% mark by July 1.

但我們確實希望他們能在 7 月 1 日或更早的時候獲得不受限制的訪問權限。這樣我們就非常接近 80% 的目標了。當然，如果計算所有覆蓋範圍，但即使只計算不受限制的訪問，我認為到 7 月 1 日我們也會接近 80% 的水平。

And we think that's very encouraging going into the summer season on top of our DTC campaign and other information we'll be putting out to make doctors more and more comfortable with the use of Nephew, we think will all come together for the summer period and really hopefully drive sales over the summer.

我們認為，在進入夏季之際，這非常令人鼓舞，此外，我們還將開展 DTC 活動並發布其他信息，讓醫生越來越放心地使用 Nephew，我們認為，所有這些都將在夏季匯聚在一起，並真正有望推動夏季的銷售。

Alexa Deemer, Cantor Fitzgerald.

亞歷克薩·迪默，康托·菲茨杰拉德。

This is Alexa Deemer on for Josh Schimmer, and congrats to the ARS Pharma team on another great year. I wanted to ask what percentage of the epinephrine market is direct to patients in comparison to the broader entities like airlines and schools?

我是 Alexa Deemer，代表 Josh Schimmer 恭喜 ARS Pharma 團隊又取得了輝煌的一年。我想問一下，與航空公司和學校等更廣泛的實體相比，腎上腺素市場有多少比例是直接面向病人的？

Okay. Currently, very little is being sold outside of the retail market. So almost all of our sales are retail, -- we are working with the two largest kit manufacturers for airlines who do want to replace other epinephrine products in the kids.

好的。目前，在零售市場之外銷售的很少。因此，我們的銷售幾乎全部來自零售——我們正在與兩家最大的航空公司套件製造商合作，他們確實希望為兒童更換其他腎上腺素產品。

Obviously, airlines have to opt in, but there's a lot of advantages to neffy between the ease of use, the lack of the needle, which reduces liability for the airlines as well as the temperature excursion data, the high temperature data, which is important in an airplane. But very little -- and Eric, you can chime in here.

顯然，航空公司必須選擇加入，但 neffy 有很多優勢，包括易於使用、無需針頭（這減少了航空公司的責任）以及溫度偏差數據、高溫數據（這在飛機上很重要）。但很少——埃里克，你可以在這裡插話。

I don't think much, if any of our revenue is coming from outside of retail. We expect that to grow over time. But initially, it takes time for that to happen. And for example, the kit manufacturers did not want to put neffy kits until the 1 milligram was available, so they're waiting because they want -- they need both doses.

如果我們的收入有任何一部分來自零售業以外，我認為不會有太大影響。我們預計這一數字會隨著時間的推移而增長。但最初，這需要時間來實現。例如，試劑盒製造商直到 1 毫克的試劑盒上市後才願意推出 Neffy 試劑盒，所以他們在等待，因為他們想要——他們需要兩種劑量。

So at that point, we expect that to start to pick up over time. And again, not immediately because they're not going to go throw away all their kits or replace all their epinephrine in the kids. They're going to do it over time as it expires.

因此，我們預計到那時，這種情況會隨著時間的推移而開始好轉。再次強調，他們不會立即採取行動，因為他們不會丟掉所有的急診包，也不會給孩子們所有的腎上腺素。他們會隨著期限的延長而做這件事。

Eric, do you want to add anything into that?

艾瑞克，你還有什麼要補充的嗎？

Rich, I'll just add that when we look at our forecasting, it's really focused on the retail market. As Rich mentioned, this public interest market of airlines, you can think about hotels, restaurants, law enforcement, emergency rescue, that's not included. But as time goes on in terms of education and awareness and then getting funding. We do have an opportunity in that channel.

里奇，我只想補充一點，當我們看我們的預測時，它確實集中在零售市場上。正如里奇所提到的，這個航空公司的公共利益市場，你可以考慮飯店、餐廳、執法、緊急救援，這些都不包括在內。但隨著時間的推移，教育和意識不斷提高，資金也不斷增加。我們在該頻道確實有機會。

And then just one point back to Ryan's question too, just people may be thinking this, the 1 milligram is also included in all of our payer contracts. So again, once that's available, there is no issues with the doctor writing to 1 milligram in addition to the 2 milligram.

然後回到 Ryan 的問題，人們可能會這麼想，1 毫克也包含在我們所有的付款人合約中。因此，一旦有了這些，醫生除了寫 2 毫克外再寫 1 毫克就沒有問題了。

And I'll just add one more point to that because one of the things you need in the retail market is to find a way to make it easier for some of these organizations such as restaurants to purchase neffy, right? So you can imagine a very well off restaurant can easily afford to buy a couple of boxes of neffy.

我只想補充一點，因為零售市場需要做的事情之一就是找到一種方法，讓一些組織（例如餐廳）更容易購買 neffy，對嗎？因此你可以想像一家非常富裕的餐廳可以輕鬆買得起幾盒 neffy。

Most restaurants run on fairly tight margins, so buying neffy to have in the restaurant is perhaps a hurdle. One of our largest advocacy groups actually came up with a great idea and is working on this independently of us because they want to see neffy in the restaurants, and they believe that without the needle, the liability, again, becomes much better so that good samaritan using neffy can't hurt themselves versus an auto-injector.

大多數餐廳的利潤都相當微薄，因此購買在餐館裡使用的 neffy 可能是一個障礙。我們最大的倡導團體之一實際上想出了一個好主意，並且正在獨立開展這項工作，因為他們希望在餐館裡看到 Neffy，他們相信，如果沒有針頭，責任就會變得更小，這樣使用 Neffy 的好心人就不會像自動注射器那樣傷害自己。

They're actually negotiating with several of the largest insurance companies, and I've mentioned this to a few analysts already to give a discount on their insurance if they have neffy in the restaurant or epinephrine in general.

他們實際上正在與幾家最大的保險公司進行談判，我已經向幾位分析師提到了這一點，如果他們在餐廳裡有 neffy 或一般有腎上腺素，他們會給他們的保險折扣。

And we think that's a brilliant idea actually because that would potentially pay for the neffy or the restaurant by giving a discount on their insurance if they actually have the epinephrine in the restaurant. So those things are all happening. But again, it will take some time before we start to realize significant revenue from those type of opportunities.

我們認為這實際上是一個絕妙的主意，因為如果餐廳裡真的有腎上腺素，那麼就有可能透過給予保險折扣來支付 neffy 或餐廳的費用。所以這些事情都在發生。但同樣，我們還需要一段時間才能從這些機會中獲得可觀的收入。

Louise Chen, Scotiabank.

加拿大豐業銀行的 Louise Chen。

Congratulations on all the progress this quarter. I had a few for you. So first question I wanted to ask you was -- how long does prior authorization for those payers that require you to do it? Usually, last or does it have to be renewed.

恭喜本季取得的所有進展。我為你準備了一些。所以我想問您的第一個問題是——對於需要您這樣做的付款人，事先授權需要多長時間？通常，最後還是必須進行更新。

The second question I had was, do you have any data that talks about that upside expansion opportunity for you and how many of those patients are actually picking up from there, those that are untreated were previously diagnosed. And then last question is I saw some headlines on the potential for epinephrine to go over the counter. I don't know if you have any thoughts on if that were to ever happen, what that would mean for you?

我的第二個問題是，您是否有任何數據可以說明您的上行擴張機會，以及有多少患者實際上從那裡康復，那些未接受治療的患者之前已被診斷出患有疾病。最後一個問題是，我看到一些關於腎上腺素有可能成為非處方藥的頭條新聞。我不知道您是否想過，如果這件事真的發生了，這對您意味著什麼？

Okay. So could you just repeat the questions one at a time, first question sorry. Just to make it clear.

好的。那麼，您能否一次重複一個問題，抱歉，第一個問題。只是為了說清楚。

Yes, sure. Okay. So I wanted to ask you with respect to prior authorization, for the payers that require you to do it? How long does this usually last for? Does it have to be renewed at some point?

是的，當然。好的。所以我想問一下，對於需要您這樣做的付款人，關於事先授權的問題？這通常會持續多久？它是否必須在某個時候進行更新？

Yes, I think -- and Eric, you can add into this, but I believe that they need a prior authorization. I mean, again, the nature of this is a little unusual. You might only get one or two or three prescriptions a year, right? So they're going to get a prior authorization for that prescription.

是的，我認為——埃里克，你可以補充這一點，但我認為他們需要事先授權。我的意思是，這件事的性質有點不尋常。您每年可能只會得到一張、兩張或三張處方，對嗎？因此，他們將獲得該處方的事先授權。

Some of them are for one, some two, we've seen three prescriptions go through or three boxes in one prescription, I should say, three units pretty readily. But I believe they would probably need that prior authorization each time, so that's a huge burden. And if you think about the revenue, on average, right now, we're seeing 1.3 units per prescription.

有些是一份，有些是兩份，我們看過三張處方，或是一張處方裡有三個盒子，我應該說，三個單位，這很容易做到。但我相信他們可能每次都需要事先授權，所以這是一個巨大的負擔。如果你考慮收入，平均而言，目前，我們看到每張處方有 1.3 個單位的收入。

Now we believe that will go up significantly because a lot of those are cash pays where they're just buying one now, and they'll get more once it's on unrestricted coverage once their insurance company is covering it. But -- if you think about it, it's only a little more than $500 in revenue to us, net revenue.

現在我們相信這個數字會大幅上升，因為很多都是現金支付，他們現在只是購買一個，一旦他們的保險公司承保，他們就會得到更多，即使沒有限制。但是——如果你仔細想想，這對我們來說只是 500 多美元的收入，淨收入。

So each prior authorization accounts for a very small net revenue, and that's why we believe in this category, it's a major hurdle for the doctors. Do you want to add anything to that Eric?

因此，每項事先授權只佔很小的淨收入，這就是我們相信這個類別的原因，這對醫生來說是一個重大障礙。艾瑞克，你還有什麼要補充的嗎？

Yes, I would just say it's a mix. It depends on the insurer, as Rich mentioned, -- some will require every single time, others may be a little bit longer. But I also think it's important as we mentioned in our presentation, that we are on track to hit that 80% of coverage in commercial. And when we say that, that's covered with no PA.

是的，我只想說這是一種混合。正如里奇所提到的，這取決於保險公司——有些保險公司每次都需要，有些可能需要更長的時間。但我認為，正如我們在演示中提到的那樣，我們有望實現 80% 的商業覆蓋率，這也很重要。當我們這麼說的時候，這意味著沒有 PA。

All of our contracts that we're putting in place with the GPOs with PBMs. Again, we're not paying any rebates if there's any type of step edit or prior authorization. So we're really confident that, again, we're lowering the barriers in time here for physicians to write this product without a PA.

我們與 GPO 和 PBM 簽訂的所有合約。再次強調，如果有任何類型的步驟編輯或事先授權，我們不會支付任何回扣。因此，我們非常有信心，我們正在降低醫生在沒有 PA 的情況下編寫該產品的門檻。

Okay. And if you could just repeat your second question again?

好的。您能再重複一下您的第二個問題嗎？

Yes, sure. Okay. So I wanted to ask you for patients that were previously diagnosed untreated with traditional epinephrine how many of them have chosen to take your product? Just trying to assess the expansion opportunity and how that's progressing for you.

是的，當然。好的。所以我想問一下，對於先前被診斷為未使用傳統腎上腺素治療的患者，有多少人選擇服用您的產品？只是想評估擴張機會以及您的進展如何。

Eric, do you have that information?

艾瑞克，你有這些資訊嗎？

We haven't broken out and done any claims analysis. We have plans to do that in the middle part of the year here. But from an opportunity perspective, as we've shared, there's 3.2 million patients that have current treatment and then you're looking at another 16.5 that are diagnosed without treatment.

我們還沒有展開並進行任何索賠分析。我們計劃在今年年中完成這項工作。但從機會角度來看，正如我們所分享的，有 320 萬名患者正在接受治療，另外還有 1,650 萬名患者在未接受治療的情況下被確診。

Within that group, we know over the last couple of years, there's 3.3 million patients that have been prescribed epinephrine about a third of them have filled, but they haven't refilled. So there is an opportunity, a significant opportunity there to reengage those patients.

我們知道，在過去的幾年中，該群體中有 330 萬名患者被開了腎上腺素，其中約三分之一的患者已經服藥，但沒有再服藥。因此，這是一個機會，一個重新吸引這些患者的重要機會。

When we talk to physicians, when we talk to patients in that group, the major reasons why they didn't refill or fill initially is because of the needle, size, portability and affordability as well. So when you look at our programs in commercial, again, if they're covered, $25 for the prescription, even if they get more than one carton, we only charge one co-pay, but we're able to, again, get reimbursed on two cartons or three cartons.

當我們與醫生交談時，當我們與該群體中的患者交談時，他們最初不補充或填充的主要原因是針頭、尺寸、便攜性和可負擔性。因此，當您查看我們的商業計劃時，同樣，如果他們被覆蓋，處方費為 25 美元，即使他們獲得不止一盒，我們也只收取一次共同支付，但我們可以再次報銷兩盒或三盒。

The average co-pay for a needle injector is about $40. So I think we're removing a lot of the challenges in terms of a needle-free, easy-to-use portable option, and we do see a very significant opportunity to reengage this population whether it's through the physician or our DTC efforts that we'll launch in May.

針頭注射器的平均共同支付費用約為 40 美元。因此，我認為我們在無針、易於使用的便攜式選項方面消除了很多挑戰，而且我們確實看到了一個非常重要的機會來重新吸引這個群體，無論是透過醫生還是我們將在 5 月啟動的 DTC 工作。

Does that help?

這樣有幫助嗎？

Yes, can I ask one more quick question?

是的，我可以再問一個簡單的問題嗎？

Yes.

是的。

The opportunity for epinephrine to go over the counter, what would that mean for you?

腎上腺素有機會成為非處方藥，這對您意味著什麼？

Yes. It's been brought up to us multiple times, including by big pharma companies. Of course, we know the inhaled epinephrine is over the counter, but it's not systemic, and it's for asthma. The two criteria for over-the-counter obviously, your first safety we believe neffy is very safe, especially with only two doses. You can overdose on epinephrine.

是的。這個問題已經多次被提及，包括大型製藥公司。當然，我們知道吸入腎上腺素是非處方藥，但它不是全身性的，而是用於治療氣喘的。非處方藥的兩個標準顯然是第一個安全標準，我們相信 neffy 非常安全，尤其是只需要兩劑。您可能服用過量的腎上腺素。

So that is a big risk and FDA has raised significant concerns about levels above that observed with two EpiPen. So that's been a big significant discussion for years and years and years that they just don't know the safety in real-world patients. with levels above that.

因此，這是一個很大的風險，FDA 對超過兩支 EpiPen 觀察到的水平表示了極大的擔憂。因此，多年來這一直是一個重大的討論，他們只是不知道現實世界患者的安全性。高於該水平。

So people that might take more than two doses and neffy would be a concern to FDA. The other criteria is self diagnosis. You got to be able to self-diagnose that you have the disease. And there's a lot of causes of symptoms similar to food allergies that may or may not be an actual food or venom allergy, so FDA would also have to get over that barrier of the ability of people to self-diagnose.

因此，服用兩劑以上劑量的人可能會引起 FDA 的擔憂。另一個標準是自我診斷。你必須能夠自我診斷自己是否患有這種疾病。有許多原因會導致類似食物過敏的症狀，這些症狀可能是也可能不是真正的食物或毒液過敏，因此 FDA 也必須克服人們自我診斷能力的障礙。

So while it's a discussion and would be interesting I think it's a difficult hurdle for this type of product, just the profile for FDA. So I would not expect it to go TC certainly in the near future. I would not expect that to happen.

因此，雖然這是一個有趣的討論，但我認為這對這類產品來說是一個難以克服的障礙，只是 FDA 的概況。所以我不希望它在不久的將來成為 TC。我並不期望這樣的事情會發生。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So I was curious, what are you hoping to learn from the challenge clinic registry study for neffy that's starting in April and around how long will that run for? And as you gather this data, would you present it in a rolling basis this year at medical meetings or publications?

所以我很好奇，您希望從 4 月開始的針對 neffy 的挑戰診所登記研究中了解到什麼，以及這項研究將持續多長時間？當您收集這些數據時，您會在今年的醫學會議或出版物上滾動地展示這些數據嗎？

Yes. So first of all, this is going to be the largest randomized controlled study ever done with epinephrine period. Never been a study like this done. But now that we're approved, FDA believes it's feasible, we believe it's feasible. So it will be 600 people treated 400 on neffy 200 on IM injection.

是的。首先，這將是迄今為止針對腎上腺素週期進行的最大規模的隨機對照研究。從來沒有進行過這樣的研究。但現在我們已獲得批准，FDA 認為這是可行的，我們也認為這是可行的。因此，將有 600 人接受治療，其中 400 人接受 neffy 治療，200 人接受肌肉注射治療。

And again, it will be randomized and partially blinded by partial, I mean, it's blinded up to the time the physician decides to give a dose of epinephrine. They won't know what the treatment is up to that point.

再次強調，這將是隨機的，並且部分盲法，我的意思是，直到醫生決定注射一劑腎上腺素時，它都是盲法的。他們還不知道到那時為止的治療方法是什麼。

The second dose would not be blinded because, of course, they know what they gave the first time it would have to be the same product the second time if they need a second dose. So this is going to be a very significant study. FDA's primary interest is safety.

第二劑不會採用盲法，因為他們當然知道第一次注射的是什麼，如果需要第二劑，第二次注射必須是相同的產品。所以這將會是一項非常重要的研究。FDA 的主要關注點是安全。

Again, as I mentioned, all of our clinical trials are in healthy people in the clinic not having a reaction. So FDA is very interested in seeing real-world data of all comers, basically, this study will be anyone they're going to give oral food challenge to is eligible to enroll. That would normally get epinephrine if they have a reaction.

再次，正如我所提到的，我們所有的臨床試驗都是在診所裡沒有出現反應的健康人群中進行的。因此，FDA 對查看所有參與者的真實世界數據非常感興趣，基本上，這項研究將針對任何有資格參加口服食物挑戰的人。如果他們有反應，通常會注射腎上腺素。

And so it's a really real-world study where you're going to get patients with asthma with all sorts of other concomitant meds. Nothing is barred in this study. So we'll get a really good sense of the safety of neffy and also of injection.

因此，這是一項真正現實世界的研究，你將招募患有氣喘並服用各種其他伴隨藥物的患者。這項研究中沒有任何禁止的事情。因此，我們將真正了解 neffy 和注射的安全性。

So even for IM injection, I don't think we have a super good sense of that in a clinical environment like this where you're really recording things that are not just spontaneously reported -- so that's the nature of the study. It's going to be -- really, it's going to be an amazing study.

因此，即使對於肌肉注射，我認為我們在像這樣的臨床環境中對此也沒有很好的認識，因為您真正記錄的並不是自發性報告的事情——這就是研究的本質。這將是——真的，這將是一項令人驚嘆的研究。

We will do an interim analysis. I don't think we'll do multiple rolling ones because that's just not normally done, but we probably will do an interim analysis so that at least preliminary data will be presented probably at the next AAAAI AI meeting and then we'll present the full data. And we will be looking at clinical outcomes as well, but those are secondaries because FDA did really focus on safety that they wanted to understand the safety of neffy have better data on the safety of neffy.

我們將進行中期分析。我認為我們不會進行多次滾動分析，因為通常不會這樣做，但我們可能會進行中期分析，以便至少在下一次 AAAAI AI 會議上提供初步數據，然後我們將提供完整的數據。我們也會關注臨床結果，但這些都是次要的，因為 FDA 確實關注安全性，他們希望了解 neffy 的安全性，並獲得有關 neffy 安全性的更好的數據。

We understand its side effects are very mild and very infrequent. But nonetheless, they want to see in patients that actually have a reaction and on all their concomitant meds or have all their other concomitant conditions that you typically see in this population. So that's really the main focus of the study. And we will probably do an interim analysis for (inaudible) so that's helpful as well.

我們知道它的副作用非常輕微且很少見。但儘管如此，他們希望看到患者確實出現了反應，並且正在服用所有伴隨藥物，或者出現了該人群中常見的所有其他伴隨症狀。這確實是這項研究的重點。我們可能會對（聽不清楚）進行中期分析，這也很有幫助。

Yes. Got it. Interesting. And then I wanted to follow up. I thought your KOLs back that you mentioned earlier was really interesting in terms of physicians that want to switch all of their patients to neffy or possibly a majority a sense of the proportion of physicians out there that you're detailing that have this interest?

是的。知道了。有趣的。然後我想跟進一下。我認為您之前提到的 KOL 確實很有趣，因為醫生希望將所有患者都轉換為 Neffy，或者可能大多數醫生都有這種興趣，您詳細說明了有多少比例的醫生有這種興趣？

I think it's mixed. I think some we talk to quad, which are really the top-tier physicians to be very honest, because they're the ones that are going for the meetings and educating themselves and I've had a number of conversations myself with a lot of these.

我認為這是混合的。我認為我們與四方會談的一些人，說實話，確實是頂級醫生，因為他們會參加會議並進行自我教育，而且我自己也與其中很多人進行過多次交談。

And one -- major one told me that he just doesn't have -- he can't spend all all evening and weekends writing PAs. So prior authorization. So he's limited, he's picking and choosing, but he would switch almost everybody, and he thinks to all of his patients would prefer neffy.

其中一位主要官員告訴我，他沒有時間——他不能把所有的晚上和週末都花在寫 PA 上。因此需要事先授權。所以他的能力有限，他只能挑選，但他會更換幾乎所有病人，而且他認為他的所有病人都會更喜歡 neffy。

And he also noted that he -- in his region, he's a major adviser to pediatricians and general practitioners. So he had thrown out that he advises about 100 pediatricians and a couple of hundred general practitioners that have patients that contact came with questions. And he said none of them will write PAs. They just won't do it. So allergists are more flexible to write these prior authorizations where pediatricians just probably have less time.

他還指出，在他的領域，他是兒科醫生和全科醫生的主要顧問。因此，他表示，他為大約 100 名兒科醫生和數百名全科醫生提供諮詢，這些醫生會聯繫那些帶著疑問前來就診的患者。他說他們中沒有人會寫 PA。他們就是不肯這麼做。因此，過敏症專家可以更靈活地撰寫這些事先授權，而兒科醫生可能沒有足夠的時間。

I don't know or they're not as equipped in their clinics to write prior authorization to manage it. So we said they just won't do it until that barrier clears. But even they're contacting him about neffy and wanting to prescribe especially again to the children are a primary focus of a lot of these doctors right now. But we think it's pretty prevalent.

我不知道，或者他們的診所沒有能力事先授權來管理它。所以我們說，除非障礙消除，否則他們不會這麼做。但即使他們就 Neffy 一事與他聯繫，並希望再次為孩子們開藥，這也是目前許多醫生關注的重點。但我們認為它相當普遍。

There are still a few that are waiting to see some real-world data and we're collecting real-world data from a nephew experience that looks spectacular right now. And once we get to a large enough. And right now, we can talk about it a little bit, if you want, but we're at about 758 patients treated that have been reported from 478 doctors and the data is coming in really like it's working at least as well as injection possibly even better.

還有一些人在等待查看一些真實世界的數據，我們正在從侄子的經歷中收集真實世界的數據，現在看起來很壯觀。一旦我們達到足夠大。現在，如果您願意，我們可以稍微談論一下，但我們已經對大約 758 名患者進行了治療，這些患者來自 478 名醫生，數據顯示，它的效果確實至少與注射一樣好，甚至可能更好。

But nonetheless, once we get to maybe a couple of thousand, we might do a publication of basically a letter to the editor -- one of the major publications to give some data. And I think that's what they're -- a lot of them are waiting for.

但儘管如此，一旦我們達到幾千份，我們可能會發表一封致編輯的信——這是提供一些數據的主要出版物之一。我認為這就是他們——很多人都在等待的。

They're waiting to see, especially the less let's say, academic scientific doctors that understand the data well. The other one, they're like, well, okay, let me see it used in a bunch of patients and it's working well, and then I'll describe. And then they all agree this is a much better profile, much better product than injection for their patients, but still a lot have that hesitation.

他們在等待觀察，尤其是那些不太了解數據的學術科學醫生。另一個，他們說，好吧，讓我看看它在一群病人身上的使用情況，效果很好，然後我再描述。然後他們都同意這對他們的病人來說是一個比注射更好的產品，但仍然有很多人猶豫。

So that's another -- one of the other two or three things we're focused on is really that access, unrestricted access, making the doctors comfortable and getting real-world data for them that it's really working equal to injection, and then the third is make is raising awareness among the patients and caregivers that neffy is available and they can go get it unrestricted without complications. They're high fees. That's going to be a big initiative as well.

所以這是另一個 — — 我們關注的另外兩三件事之一實際上是訪問，不受限制的訪問，讓醫生感到舒適並為他們獲取真實世界的數據，確保它確實與注射一樣有效，然後第三是提高患者和護理人員的認識，讓他們知道 Neffy 是可用的，他們可以不受限制地獲取它而不會出現並發症。費用很高。這也將是一項重大舉措。

And that's why we're aligning our DTC campaign with that access occurring and -- some people say north of 50% is already good enough to start driving patients into the doctors. We're actually going to start that process when we're hopefully closer to the 80% mark so that people will get it very easily and without high co-pay.

這就是為什麼我們要將 DTC 活動與這種訪問結合起來——有些人說 50% 以上已經足以開始推動患者去看醫生。當我們希望達到 80% 左右時，我們就會真正啟動這個流程，讓人們可以非常輕鬆地獲得醫療保險，而且無需支付高額的共同費用。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

I guess the first one is just -- can you talk about the system that you have to go back to doctors or patients who were written a script and it wasn't approved once you get coverage with the insurer and the system you haven't maybe what you've seen from that so far as you've won for

我想第一個問題是──你能談談這個系統嗎？你必須回到醫生或病人那裡，他們寫了處方，但一旦你獲得保險公司的承保，處方就沒有得到批准，而且你還沒有看到這個系統，到目前為止，你已經贏得了

Two different things I would separate. If it's through Blinkx our online pharmacy, then BlinkerX is obviously keeping record of all patients who are denied a prior authorization or who even filed a prior authorization. So we have all that data and their contact information because they went through blinker X.

我要將兩件不同的事情區分開來。如果是透過我們的線上藥局 Blinkx，那麼 BlinkerX 顯然會記錄所有被拒絕事先授權或甚至提交了事先授權的患者的記錄。因為他們通過了閃光燈 X，所以我們擁有所有這些數據和他們的聯絡資訊。

So as insurers are added to coverage and we get unrestricted coverage with new insurers, they can go back and inform the patient as well as the doctor that, that patient is now covered and can go back and get neffy without a prior authorization. So that's one thing I think Eric's team is doing quite effectively.

因此，隨著保險公司加入承保範圍，我們獲得新保險公司的無限制承保，他們可以回去通知患者和醫生，該患者現在已獲得承保，並且可以在未經事先授權的情況下回去接受治療。所以我認為埃里克的團隊在這方面做得非常有效。

The other is a little harder to deal with if it was a script written through a pharmacy. And of course, even if we have the cash pay in place or patient goes and they don't have that co-pay assistance -- you've got people walk away from the script that we don't want.

如果處方是透過藥局開的，那麼處理起來就比較困難一些。當然，即使我們實施現金支付，或是病人沒有共同支付援助，也會有人放棄我們不想要的處方。

We want them to go to the pharmacy and have that $25 co-pay. So in that regard, we're doing a couple of things. The sales force is really tasked with informing the doctors that their patients are now covered for, let's say, United as of April 1, right?

我們希望他們去藥房並支付 25 美元的共同支付費用。因此，在這方面，我們正在做一些事情。銷售人員的實際任務是通知醫生，他們的病人現在已享有聯合醫療保險，例如從 4 月 1 日起，對嗎？

So another couple of weeks, if you're a UnitedHealth patient, which is about 8% of the United States commercial insurance, you can now go back and get that script again? Or if the script is still valid, just go back to the pharmacy and get neffy and not have to have the prior authorization.

那麼再過幾週，如果你是聯合健康集團的患者（該集團約占美國商業保險的 8%），你現在可以回去再次獲得該處方嗎？或者如果處方仍然有效，只需返回藥房並獲取 neffy，而不必事先獲得授權。

On top of that, we also don't want patients to walk away from a co-pay. So if they have a with United if they have an $80 co-pay. Just throwing out a number, just as an example, but you have an $80 co-pay for neffy with United, and you don't want to pay $80, but you would easily pay $25 you have to have our coupon from our website from your smartphone to give to the pharmacists.

除此之外，我們也不希望病人放棄共同支付。因此，如果他們與聯合航空有合作，則需要支付 80 美元的共同支付費用。只是舉個數字，例如，您需要向 United 支付 80 美元的 neffy 共同費用，而您不想支付 80 美元，但您願意支付 25 美元，您必須從我們的網站上用智慧型手機獲取優惠券，然後交給藥劑師。

We are now working very hard with both CVS and really Health to sign agreements to preload that card. So when patients and caregivers go to the pharmacy, it will be automatic that they won't they won't have to have the coupon and if they forgot the coupons.

我們現在正努力與 CVS 和 Really Health 合作簽署預充該卡的協議。因此，當患者和照護者去藥局時，他們會自動不需要優惠券，也不會忘記優惠券。

And surprisingly, even somebody I know who's used neffy multiple times already, she has a lot of different allergies and she's a very smart person, very -- she actually paid $200 for neffy and she had authorization. She had prior authorization approved or insurance coverage, and I was shocked.

令人驚訝的是，即使我認識的一個人已經多次使用過 neffy，她也有很多不同的過敏症，而且她非常聰明，非常——她實際上為 neffy 支付了 200 美元，並且獲得了授權。她事先獲得了授權批准或保險覆蓋，這讓我很震驚。

And I said, well, didn't you use the coupon and. I don't like -- so we don't want that because she obviously could afford and she didn't think anything of $200. But to a lot of people, $200 as a barrier, and we'll walk away from the script.

我說，好吧，你沒有使用優惠券嗎？我不喜歡——所以我們不想要那樣，因為她顯然負擔得起，而且她對 200 美元不以為意。但對很多人來說，200 美元是一個障礙，我們就會放棄這個劇本。

So we're trying to get that done as well to make sure that it's seamless, meaning you get your script from the doctor, you go to the local pharmacy you hand the script to the pharmacy or sent electronically, of course, these days, so you don't actually have a physical script, but you go into the pharmacy and they just say, your copay is $25, and you walk away happy. And that's really what we're trying to get to make that as seamless as possible for the vast majority of the population as quickly as possible and especially going into this summer.

因此，我們也在努力做到這一點，以確保它是無縫的，這意味著你從醫生那裡得到你的處方，你去當地的藥房，把處方交給藥房，或者以電子方式發送，當然，這些天，所以你實際上沒有實體處方，但你走進藥房，他們只是說，你的自付額是 25 美元，你高興高興地走開。這正是我們真正想要實現的目標，即盡快讓絕大多數人盡可能無縫地享受這項服務，尤其是在今年夏天。

Great. I mean, can you comment on the coverage that you've won so far? Have you seen many of those groups, for example, the ones through BlinkRx go back in that filled? Or are those patients maybe when the initial script is denied, do they just get a script for an auto injector?

偉大的。我的意思是，您能評論一下迄今為止您贏得的報道嗎？您是否見過許多這樣的團體，例如透過 BlinkRx 回來的團體？或者當這些患者在最初的處方被拒絕時，他們是否只獲得自動注射器的處方？

Yes. I'll refer Eric. Eric, do you have any information on that as to when BlinkRx goes back after coverage?

是的。我會推薦埃里克。Eric，您是否知道 BlinkRx 在覆蓋範圍結束後何時會恢復？

Yes. Lachlan, we are seeing a percentage of those patients convert -- we have a protocol in place, as Rich mentioned, once we get coverage, and we've been doing this over the last couple of weeks, we're reengaging those patients.

是的。拉克蘭，我們看到這些患者中有一定比例發生了轉變——正如里奇提到的，我們已經制定了一項協議，一旦我們獲得覆蓋，並且我們在過去幾週一直在這樣做，我們就會重新吸引這些患者。

A portion of those patients opted to go to the cash prescription. But the other ones, we're getting a nice amount of them coming back and saying, okay, hey, great, now that my insurance is covering this. It's affordable.

其中一部分患者選擇現金處方。但是其他的，我們收到了很多回饋，他們說，好的，嘿，太好了，現在我的保險已經涵蓋了這一點。價格便宜。

They're moving from a submitted prescription that's waiting to obviously a dispensed prescriptions that they have. So we're not only doing that, as Rick said, with BlinkRx, but our field team is also trained to engage the doctors on all these updates really working close with the staff because it's they're carrying that workload to of working with the patients and going through that process.

他們正在從等待提交的處方轉向顯然已經配發的處方。因此，正如 Rick 所說，我們不僅透過 BlinkRx 做到這一點，而且我們的現場團隊也接受了培訓，讓醫生參與所有這些更新中，真正與工作人員密切合作，因為他們承擔著與患者合作並經歷這一過程的工作量。

So the field team has data based on each position of what payers their patient base represents and they're messaging accordingly. So we're pulling that through and driving that -- all those wins that we're seeing.

因此，現場團隊可以根據患者群體所代表的付款人的各個位置獲取數據，並據此發送訊息。因此，我們正在努力實現這一目標並取得我們所看到的所有勝利。

Great I can ask a follow-up. Go ahead.

太好了，我可以問後續問題。前進。

No, no. I was just going to add that, again, a lot of people are telling us that they're just getting -- if they're not covered, they're getting one now, but they want more than one prescription, so they're getting on now at the cash pay price of $1.99 and then they're waiting for coverage to -- for their insurer to cover neffy so they can go back and get more because that seems to be a common strategy, common theme we're hearing from patients and caregivers that they just want the one initially.

不，不。我只是想補充一點，很多人告訴我們，如果他們沒有保險，他們現在就可以得到一張，但他們想要不止一張處方，所以他們現在以 1.99 美元的現金支付價格購買，然後他們等待保險——等待他們的保險公司承保 neffy，這樣他們就可以回去得到更多，因為這似乎是一種常見的策略，我們從患者和護理人員那裡聽到的共同主題是，他們最初聽到的共同主題。

And I know we just spoke to somebody an advocacy person in Utah state advocacy person that's working on the legislation in Utah and her kids both have this disease, and she has neffy, she was just waiting for her cases, everything she wants her kids to carry it, right? She just loves neffy because their kids can actually carry it. So she went out and got it.

我知道我們剛剛和猶他州的一位倡導者交談過，她正在為猶他州的立法工作，她的孩子都患有這種疾病，她也有這種病，她只是在等待她的病例，她希望她的孩子也攜帶這種疾病，對嗎？她非常喜歡 neffy，因為他們的孩子實際上可以攜帶它。於是她就出去把它拿來了。

And I'm sure she'll get more prescriptions, you just wanted to get one for each of the kids initially so that they have the neffy in their hands walking around with it, and they're really thrilled about it. So that's the feedback we get all the time and heard from a lot of people already in that mode of -- I'll pay for the one at the $199, but then I'll wait for insurance for more.

我相信她會得到更多的處方，你最初只是想為每個孩子買一個，這樣他們就可以隨身攜帶，他們對此感到非常興奮。這就是我們一直收到的回饋，也是從很多人那裡聽到的——我會花 199 美元買一個，但之後我會等待保險來獲得更多。

Okay. Great. That's great context. And as a follow-up, you've talked about how access and getting the payer coverage is really important to driving prescription because of that prior authorization burden. Can you talk about the maybe lag that you see there?

好的。偉大的。這是非常好的背景。作為後續問題，您談到了由於事先授權負擔，獲得醫療服務以及獲得付款人承保對於推動處方至關重要。您能談談您在那裡看到的可能的滯後嗎？

I mean how quickly -- when you sign a new contract so far when you signed new contracts and got on formulary. Are you able to see an uptick in prescribing over the following weeks or a couple of months? Or like how should we think about what that delay.

我的意思是，當你簽署新合約並獲得處方時，速度有多快。您是否能夠在接下來的幾週或幾個月內看到處方量上升？或者我們應該如何看待這種延遲。

It's a great question because I just asked that question yesterday of my team. And I think they're still collecting to date. I don't know, Eric, if you have it, I haven't seen it yet, but the example is like Express Scripts, which started now a couple of months ago, it really hit with Express Scripts.

這是一個很好的問題，因為我昨天剛向我的團隊問過這個問題。我認為他們至今仍在收集。我不知道，艾瑞克，如果你有的話，我還沒看到，但這個例子就像 Express Scripts，幾個月前開始的，它真的對 Express Scripts 產生了影響。

So how are the sales going now in the patients under Express Scripts versus other insurance companies, which may have only recently added neffy. So it's not -- the data won't be as impactful. But I don't know, Eric, do we have any sense of that yet?

那麼，與其他最近才增加 neffy 的保險公司相比，Express Scripts 旗下病患的銷售情況如何？所以，數據不會產生那麼大的影響。但是我不知道，艾瑞克，我們是否已經意識到這一點了？

Yes. We are looking at individual cohorts of patients based on insurance. I can tell you that the last couple of weeks, especially with like Express Scripts, we're seeing an incline there in terms of share relative to what we see in the overall average.

是的。我們正在根據保險情況研究個別患者群體。我可以告訴你，最近幾週，特別是像快捷藥方這樣的公司，我們看到其市場份額相對於整體平均水平有所上升。

So that's what we expect to see. And for each of those plans that we're winning, we're driving that through messaging, whether it's nonpersonal promotion through marketing, but most importantly, through our direct efforts with our field team interacting with doctors, interacting with staff.

這就是我們所期望看到的。對於我們贏得的每一個計劃，我們都透過訊息傳遞來推動，無論是透過行銷進行非個人推廣，但最重要的是，透過我們與現場團隊的直接努力與醫生互動，與員工互動。

I would say also that it takes time when the patient comes in, right, certain patients see their doctor every six months, others maybe every year. But when they come in, now the doctor knows that if that patient has Express Scripts starting April 1, United that this is going to be covered without a prior authorization.

我還想說，病人來就診需要時間，有些病人每六個月看一次醫生，有些病人可能每年看一次醫生。但當他們進來時，現在醫生知道，如果該患者從 4 月 1 日起擁有快捷藥方，聯合醫療將在無需事先授權的情況下獲得承保。

So we are encouraged by what we're seeing in terms of the increases here and it does really create a nice opportunity for us over the next couple of weeks and especially going into the the May back-to-school season with a lot of patients coming in to really drive this.

因此，我們對這裡的成長感到鼓舞，這確實為我們在接下來的幾週創造了一個很好的機會，特別是進入五月返校季節，許多患者會來真正推動這一點。

And just to add one more thing to that. I know we're actually going a little over time a little bit. But we just are now working with advocacy and our website posting a scorecard. We wanted to wait until we cross that 50% mark if United gets us there.

我再補充一點。我知道我們其實已經有點超時了。但我們現在正在進行宣傳工作，並在我們的網站上發布記分卡。如果美聯航能幫我們達到這個目標，我們希望等到突破 50% 大關。

But we're putting the scorecard and the advocacy groups are going to post this on their websites as well under their neffy description, where it's going to show who's covering without any restrictions, without any prior authorization, who's covering, but is still requiring prior authorization again, I don't differentiate between the insurer that's covering with prioritization on that's not covering at all. And then who's not covering it all. And there's two purposes of this.

但是，我們正在製作記分卡，倡導團體也會將其發佈在他們的網站上，並在他們的漂亮描述下，其中將顯示誰在沒有任何限制、沒有任何事先授權的情況下承保，誰在承保，但仍然需要事先授權，我沒有區分優先承保的保險公司和根本不承保的保險公司。那麼誰沒有涵蓋這一切呢？這樣做有兩個目的。

One is that I want I want the patients to know they're covered and the caregivers, right? And the doctors, so the scorecard is also being shared by our sales force with the doctors. But I also want them to know who's not covering because if your insurer is not covering and you see this whole list of insurers that are and you go and call up your insurer and say, hey, why are you guys not covering this and all these other insurers are covering it. We think that puts a lot of pressure on insurance companies to cover more quickly.

一是我希望病人和照護人員知道他們受到了保障，對嗎？因此我們的銷售人員也會與醫生分享記分卡。但我也想讓他們知道誰沒有承保，因為如果你的保險公司沒有承保，而你看到了承保的保險公司的整個名單，你去打電話給你的保險公司說，嘿，為什麼你們不承保這個，而所有其他保險公司都承保了。我們認為這給保險公司帶來了很大的壓力，迫使他們更快地提供保障。

So that's another strategy we have to try to facilitate that by now starting to make it very public who is covering without this prior authorization requirement and who is not, and we're hoping that, that will also start to have some impact over time.

因此，我們必須嘗試採取另一種策略，即從現在開始公開哪些人沒有事先獲得授權，哪些人沒有，我們希望，隨著時間的推移，這種策略也能開始產生一些影響。

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

Congrats on all the recent progress. On the CSC Phase 2b trial you expect to initiate in the next few weeks, I'm wondering if you could remind us of the competitive positioning here? And any early feedback you have on preference for episodic relief versus chronic therapies in CSC.

恭喜你最近的所有進展。關於您預計將在未來幾週內啟動的 CSC 2b 期試驗，我想知道您是否可以提醒我們這裡的競爭定位？您對 CSC 中間歇性緩解療法和慢性療法的偏好有何早期回饋？

Yes. Well, first of all, they're very independent, okay, because these people are all in chronic therapy, right? So you could be on chronic antihistamine high-dose enters gene therapy or high-dose XOLAIR and you still have flares.

是的。嗯，首先，他們非常獨立，因為這些人都在接受慢性治療，對吧？因此，您可能正在接受慢性抗組織胺高劑量基因治療或高劑量 XOLAIR，但病情仍然發作。

So what there is no current therapy for is to flares, meaning you're on Xolair and you're stable, but every couple of months, you have a big episode where you've got a couple of days to two days of severe symptoms, all of a sudden, and it's very, very upsetting to these people. And a lot of times, they get not only the itchy and painful, but they also sometimes get angioedema facial angioedema, so their lip swells up, their cheek swells up, they don't want to go to work.

因此，目前無法治療的是疾病發作，也就是說，你正在使用 Xolair，病情穩定，但每隔幾個月，就會出現一次嚴重的發作，突然出現幾天到兩天的嚴重症狀，這對這些人來說非常非常令人不安。很多時候，他們不僅會感到搔癢和疼痛，有時還會出現血管性水腫（臉部血管性水腫），所以他們的嘴唇會腫起來，臉頰會腫起來，他們不想去上班。

They don't want to go out, while that's happening. So the difference is you're on your chronic therapy and then you have a flare and now you can have an immediate treatment to treat that flare and resolve it within minutes.

當這種情況發生時，他們不想出去。所以不同之處在於，您正在接受慢性治療，然後病情突然發作，現在您可以立即接受治療以治療該病情並在幾分鐘內解決。

And then go back and just go back to your daily life, go to work, go wherever you want to go, versus go to the hospital and get -- the other current ways they deal with this flare is you either just tolerate it and hope -- or wait for it to go away because it will go away. And you -- or you go to the hospital and get IV antihistamines at very high doses tends to be effective in a lot of cases.

然後回去，回到你的日常生活中，去上班，去任何你想去的地方，而不是去醫院——他們目前處理這種疾病的其他方法是，你要么忍受它並希望——要么等待它消失，因為它會消失。或者你去醫院注射大劑量的靜脈抗組織胺藥，在許多情況下往往是有效的。

And then the other is to take a steroid, which takes hours to take effect, okay? So neffy would provide a unique advantage of treating that acute event. While they're on chronic therapy, so it's synergistic with chronic therapy. I just want to make sure it's clear that we are not intending to replace chronic urticaria therapy at all. This is a supplemental treatment to treat that exacerbation that occurs.

另一種方法是服用類固醇，這需要幾個小時才能起效，好嗎？因此，neffy 在治療這種急性事件方面具有獨特的優勢。當他們接受慢性治療時，它與慢性治療有協同作用。我只是想明確說明，我們根本沒有打算取代慢性蕁麻疹治療。這是一種治療發生的病情惡化的補充療法。

And if you go back to the XOLAIR Phase 3 studies that were published, People on XOLAIR even will have three to six of these events a year. And then -- well, they actually more than three to six events, I should take that back. It was -- they went to the emergency room three to six times a year to treat this type of event.

如果你回顧已發表的 XOLAIR 第 3 階段研究，你會發現服用 XOLAIR 的人每年甚至會出現三到六次此類事件。然後——嗯，他們實際上舉辦了三到六次以上的活動，我應該收回我的話。是的——他們每年要去急診室三到六次來治療這類事件。

So it's a pretty significant issue even on chronic therapies like XOLAIR. Now there are a portion of people that are just stable on XOLAIR antihistamines that never have these events but there's a large proportion of people that have these events.

因此，即使對於像 XOLAIR 這樣的慢性療法來說，這也是一個相當重要的問題。現在，有一部分人只使用 XOLAIR 抗組織胺藥，從未發生過這些事件，但也有很大一部分人發生過這些事件。

So it is an unmet medical need. We're not proposing to replace chronic urticaria therapies. We're looking at supplementing them. Does that help?

因此，這是一個尚未滿足的醫療需求。我們並不是提議取代慢性蕁麻疹療法。我們正在考慮對它們進行補充。這樣有幫助嗎？

That's very helpful.

這非常有幫助。

And I'm not showing any further questions at this time. I'd like to turn the call back over to Richard.

我現在不想再問任何問題。我想把電話轉回理查。

Okay. Well, I really appreciate everybody joining the call and look forward to the next conference call when we get closer to that summer period. Obviously, we think at that point, we're hoping to see a significant uptick in scripts and then going into the summer when our DTC campaign starts in May. We really start raising that awareness.

好的。好吧，我非常感謝大家參加電話會議，並期待我們接近夏季時的下一次電話會議。顯然，我們認為，我們希望看到劇本數量大幅上升，然後進入夏季，屆時我們的 DTC 活動將於 5 月開始。我們確實開始提高這種意識。

And we think you'll really enjoy our DTC campaign where we've been working very hard, and we think it will be very, very positive shifting the thinking, shifting the paradigm towards neffy easy, easy to carry, easy to use and not threatening and treat the symptoms immediately and they'll wait for severe anphylactic disease.

我們認為您一定會喜歡我們為之付出巨大努力的 DTC 活動，我們認為它將非常非常積極地轉變思維，將模式轉向更簡單、更易於攜帶、更容易使用、不具威脅性，並能立即治療症狀，而他們會等待嚴重的過敏性疾病。

So we think that, that will really shift the paradigm towards earlier and earlier use of epinephrine in order to stop the symptoms immediately when a reaction occurs. And that's really how doctors want to see epinephrine used. So with that, I'll close the call.

因此我們認為，這將真正改變模式，越來越早地使用腎上腺素，以便在發生反應時立即阻止症狀。這正是醫生希望看到的腎上腺素的用途。好了，我要結束本次通話了。

Thank you. Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.

謝謝。女士們、先生們，今天的演講到此結束。現在您可以斷開連接，享受美好的一天。