Avadel Pharmaceuticals PLC (AVDL) 2023 Q2 法說會逐字稿

Greetings, and welcome to the Avadel Pharmaceuticals Second Quarter 2023 Earnings Call. (Operator Instructions). As a reminder, this conference is being recorded. It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. Thank you. You may begin.

您好，歡迎參加 Avadel Pharmaceuticals 2023 年第二季度收益電話會議。 （操作員說明）。提醒一下，本次會議正在錄製中。現在我很高興向斯特恩投資者關係部介紹奧斯汀·默塔。謝謝。你可以開始了。

Good morning, and thank you for joining us on our conference call to discuss second quarter 2023 earnings. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

早上好，感謝您參加我們的電話會議，討論 2023 年第二季度的收益。提醒一下，在我們開始之前，以下演示包括構成 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述的若干事項。

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks regarding the success of commercialization efforts for LUMRYZ, expectations regarding the potential market impact, anticipated market availability and sales opportunities of LUMRYZ and the impact of competitive products and pricing. These and other risks are described more fully in Avadel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2022, which was filed on March 29, 2023, and any subsequent SEC filings.

前瞻性陳述存在風險和不確定性，可能導致實際結果與此類前瞻性陳述中預期的結果存在重大差異。這些風險包括有關 LUMRYZ 商業化工作成功的風險、有關 LUMRYZ 潛在市場影響的預期、預期市場可用性和銷售機會以及競爭產品和定價的影響。這些風險和其他風險在Avadel 根據《交易法》提交的公開文件中進行了更全面的描述，該文件包含在截至2022 年12 月31 日的年度10-K 表格（於2023 年3 月29 日提交）以及任何後續的SEC 文件中。

Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. On the call today are Greg Divis, Chief Executive Officer; Dr. Jennifer Gudeman, Senior Vice President of Medical and Clinical Affairs; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer. At this time, I'll turn the call over to Greg.

除法律要求外，Avadel 不承擔更新或修改本演示文稿中包含的任何前瞻性陳述以反映新信息、未來事件或其他情況的義務。今天參加電話會議的是首席執行官格雷格·迪維斯 (Greg Divis)； Jennifer Gudeman 博士，醫療和臨床事務高級副總裁；理查德·金，首席商務官；和首席財務官湯姆·麥克休。這個時候，我會把電話轉給格雷格。

Thank you, Austin. Good morning, everyone, and thank you for joining us today to review our second quarter 2023 results. 2023 continues to be a transformational year for Avadel, which has only accelerated with the significant progress our team has delivered in the second quarter alone. And this all starts with our transition to a commercial stage organization and the launch of LUMRYZ. Our once-at-bedtime oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

謝謝你，奧斯汀。大家早上好，感謝您今天加入我們回顧我們 2023 年第二季度的業績。 2023 年對於 Avadel 來說仍然是轉型的一年，我們的團隊僅在第二季度就取得了重大進展，這一轉變的步伐只會加快。這一切都始於我們向商業舞台組織的轉變和 LUMRYZ 的推出。我們的睡前一次羥丁療法用於治療成人發作性睡病的猝倒或白天過度嗜睡。

Following LUMRYZ's approval in May, along with the concurrent receipt of orphan drug exclusivity, we swiftly executed our launch strategy and since launch in June have seen impressive interest and initial uptake from physicians and a broad mix of patients. We recorded our first sales for LUMRYZ in June. And based on our initial launch progress, we are trending well against our expectations at this very early stage in the launch. With clear and unwavering focus, we are honored to be able to bring forward our transformational once-at-bedtime therapy, the narcolepsy community has long been waiting for.

繼 LUMRYZ 在 5 月份獲得批准，同時獲得孤兒藥獨占權後，我們迅速執行了我們的上市策略，自 6 月份上市以來，醫生和廣大患者產生了濃厚的興趣和初步採用。我們在 6 月份錄得了 LUMRYZ 的首次銷售。根據我們最初的發布進度，在發布的早期階段，我們的趨勢遠遠超出了我們的預期。憑藉明確和堅定不移的重點，我們很榮幸能夠推出嗜睡症社區期待已久的革命性睡前一次治療。

On today's call, I'm joined by Richard who will be providing updates on our commercial launch progress. Following Richard, Jen will be discussing our robust clinical presence at the Sleep Conference and our recent publications. We will then turn the call over to Tom to update on the financial results. And lastly, we will close the call with a question-and-answer session.

在今天的電話會議上，理查德也加入了我的行列，他將提供我們商業發布進展的最新信息。繼 Richard 之後，Jen 將在睡眠會議上討論我們強大的臨床表現以及我們最近的出版物。然後我們會將電話轉給湯姆以更新財務業績。最後，我們將以問答環節結束此次通話。

Before commenting on our launch progress, I want to take a moment to highlight the receipt of orphan drug exclusivity in May. At the same time, the FDA granted LUMRYZ's final approval as this is an important validation of the benefit of LUMRYZ. The FDA filed LUMRYZ to be clinically superior to all twice-nightly oxybate products and that LUMRYZ makes a major contribution to patient care by providing a once-nightly dosing regimen that avoids nocturnal arousal, which disrupts sleep architecture when required to be forcibly awaken in the middle of the night to take a second dose.

在評論我們的上市進展之前，我想花點時間強調一下 5 月份獲得的孤兒藥獨家經營權。同時，FDA授予了LUMRYZ的最終批准，這是對LUMRYZ益處的重要驗證。 FDA 備案LUMRYZ 在臨床上優於所有每晚兩次的羥丁產品，並且LUMRYZ 通過提供每晚一次的給藥方案來避免夜間喚醒，從而在需要強行喚醒時擾亂睡眠結構，從而為患者護理做出了重大貢獻。半夜服用第二劑。

As many of you know, at the end of June, we held a widely attended LUMRYZ Commercial Day, where we highlighted the significant opportunity of LUMRYZ, demonstrated our history of resilience, showcased our talented team, reported initial launch metrics and discussed how we are well positioned for future growth. In addition, we hosted 2 renowned sleep specialists who spoke about their extensive experience with treating narcolepsy patients and how they believe LUMRYZ will positively impact the treatment landscape for people with narcolepsy.

正如你們許多人所知，6 月底，我們舉辦了一場廣泛參與的LUMRYZ 商業日，我們在會上強調了LUMRYZ 的重大機遇，展示了我們的韌性歷史，展示了我們才華橫溢的團隊，報告了初始發布指標，並討論了我們的發展狀況為未來的增長做好了準備。此外，我們還接待了兩位著名的睡眠專家，他們講述了他們在治療發作性睡病患者方面的豐富經驗，以及他們如何相信 LUMRYZ 將對發作性睡病患者的治療前景產生積極影響。

We were also honored to have a person with narcolepsy in attendance, who gave a first-hand account of her experience living with narcolepsy, first generation oxybates and how LUMRYZ positively transformed her life. Today, we are updating initial metrics previously reported. Specifically, the 3 most important early launch KPIs that we reviewed at our commercial day and are now reporting data through the first 2 months of launch. The significant progress we have seen across these important KPIs during these early weeks of launch are as follows: first, REMS certifications, which is the first step before prescription can be written, are now greater than 1,000 targeted prescribers who are certified. That's up from 625 as previously reported.

我們還很榮幸邀請到一位嗜睡症患者，她親自講述了她患有嗜睡症的經歷、第一代羥丁酸鹽以及 LUMRYZ 如何積極改變她的生活。今天，我們正在更新之前報告的初始指標。具體來說，我們在商業日審查了 3 個最重要的早期發布 KPI，現在正在報告發布前 2 個月的數據。在推出的最初幾週內，我們在這些重要 KPI 上看到的重大進展如下：首先，REMS 認證是開具處方之前的第一步，目前已有超過 1,000 名目標處方者獲得了認證。這比之前報導的 625 個有所增加。

Second, new patient enrollments into RYZUP, our patient services center, which is the first step to a potential future dispense of LUMRYZ, are now greater than 400 patient enrollments, up from 140 as previously reported. And third, progress on the reimbursement front, which is also performing ahead of expectations, which now includes the addition of LUMRYZ to the Express Scripts' national formulary and now hot off the press, CVS Health has removed the new-to-market block for LUMRYZ on its commercial formularies in a non-preferred position. This decision now allows a pathway to coverage for more than 30 million additional commercial lines.

其次，我們的患者服務中心 RYZUP 的新註冊患者人數目前已超過 400 名，高於之前報導的 140 名，這是未來可能發放 LUMRYZ 的第一步。第三，報銷方面的進展，其表現也超出了預期，其中包括將 LUMRYZ 添加到 Express Scripts 的國家處方集中，並且現在新聞報導很熱，CVS Health 已取消了新上市的障礙LUMRYZ 在其商業處方集上處於非優先地位。這一決定現在為覆蓋超過 3000 萬條額外的商業線路提供了一條途徑。

In summary, from a leading KPI perspective, while recognizing we are only in the first full quarter of launch right now with significant work ahead of us, we are pleased with these early indicators of our launch progress. Looking at future quarters as our launch progresses, we expect the KPIs that provide a current picture of launch to evolve. And our goal, as it always has been, is to be transparent as we report metrics that capture our launch progress. Further, we expect to give all launched KPI updates on our quarterly earnings calls where all data provided will be as of quarter end. Looking toward the future and the continued growth of Avadel, our strategy is to target opportunities that allow us to expand our patient reach in the rare sleep space with the goal to provide innovative therapies like LUMRYZ to more eligible patients. In this regard, our team is on track to submit a supplemental new drug application for potential FDA approval of LUMRYZ in the pediatric narcolepsy population before the end of the 2023 calendar year.

總之，從領先的 KPI 角度來看，雖然我們認識到我們目前僅處於發布的第一個完整季度，還有大量工作要做，但我們對這些發布進度的早期指標感到滿意。展望未來幾個季度，隨著我們的發布進展，我們預計提供當前發布情況的 KPI 將會不斷發展。我們的目標一如既往，是在報告反映發布進度的指標時保持透明。此外，我們預計將在季度收益電話會議上提供所有發布的 KPI 更新，其中提供的所有數據均截至季度末。展望 Avadel 的未來和持續增長，我們的戰略是尋找機會，擴大我們在稀有睡眠空間中的患者覆蓋範圍，目標是為更多符合條件的患者提供 LUMRYZ 等創新療法。在這方面，我們的團隊有望在 2023 年底之前提交一份補充新藥申請，以便 FDA 批准 LUMRYZ 用於治療兒童發作性睡病人群。

Additionally, we are progressing the clinical planning to initiate a multicenter randomized controlled trial in idiopathic hypersomnia and lastly, we continue our preclinical stage formulation work of a potential no or low sodium once-at-bedtime oxybate formulation for the small subset of sodium-sensitive oxybate eligible patients who could potentially benefit from this type of innovation. We look forward to providing updates as appropriate as physicians and patients have expressed significant interest in Avadel developing these needed treatment options. Although it's very early with much more to accomplish during the first few full quarters of launch, we are very pleased based on our early launch KPIs with our initial execution and continued pursuit of greater than the $1 billion peak sales potential opportunity that is there for LUMRYZ. I will now turn the call over to Richard to provide an update on our launch progress. Richard?

此外，我們正在推進臨床計劃，以啟動一項針對特發性嗜睡症的多中心隨機對照試驗，最後，我們繼續進行臨床前階段的製劑工作，研究潛在的無鈉或低鈉睡前一次羥丁酯製劑，用於一小部分對鈉敏感的患者羥丁治療符合條件的患者可能會從此類創新中受益。我們期待提供適當的更新信息，因為醫生和患者對 Avadel 開發這些所需的治療方案表現出了濃厚的興趣。儘管現在還為時過早，在發布的前幾個完整季度中還有很多工作要做，但根據我們的早期發布KPI、我們的初步執行以及對LUMRYZ 超過10 億美元峰值銷售潛力機會的持續追求，我們感到非常高興。我現在將把電話轉給理查德，以提供我們發布進度的最新信息。理查德？

Thanks, Greg, and good morning, everyone. Our LUMRYZ launch is off to a strong start and excited to share our continued progress. Now over the last 20 years, there has not been any innovation in improving the delivery of oxybate to people with narcolepsy. The fundamental problem of forcibly awaking patients who often already suffer from disturbances in nocturnal sleep existed until once-at-bedtime LUMRYZ was approved and launched in June.

謝謝格雷格，大家早上好。我們的 LUMRYZ 發布有了一個良好的開端，我們很高興與大家分享我們的持續進展。過去 20 年來，在改善發作性睡病患者的羥丁酸輸送方面尚未出現任何創新。強制叫醒患者的根本問題一直存在，這些患者通常已經患有夜間睡眠障礙，直到睡前一次的 LUMRYZ 於 6 月獲得批准並上市。

With LUMRYZ, we have a simple and compelling proposition. And what we are seeing and hearing in the early weeks of our launch is a validation of our brand proposition and the market insights we had at prelaunch. Safe to say, we believe LUMRYZ provides a meaningful benefit to the narcolepsy community. And of course, this was further validated through the receipt of our orphan drug exclusivity from the FDA.

通過 LUMRYZ，我們有一個簡單而引人注目的主張。我們在發布的最初幾週所看到和聽到的是對我們的品牌主張和我們在發布前的市場洞察的驗證。可以肯定地說，我們相信 LUMRYZ 為嗜睡症社區帶來了有意義的益處。當然，通過 FDA 授予我們的孤兒藥獨家經營權，這一點得到了進一步驗證。

Turning to the commercial launch itself. We are approximately 2 months in. We are encouraged by the strong progress thus far and the positive feedback we received from the narcolepsy community. Many from our leadership team and I have had the privilege of being on the road with members of our field force and speaking with sleep specialists and their team's firsthand. Considering that collectively we are a relatively new team in the sleep field, the energy of our team and the engagement of sleep specialists has been terrific. As our launch continues, we are focused on continuing to drive demand among high-volume oxybate prescribers, encouraging patients to advocate for the use of LUMRYZ securing payer coverage and delivering best-in-class patient services and reimbursement support. From a launch team perspective, as of the end of July, all roles are now built and trained. In August, we will mark the first month with a fully deployed team. We continue to see very high interest and levels of engagement from sleep specialists and their staff.

轉向商業發布本身。我們已經大約兩個月了。迄今為止取得的巨大進展以及我們從嗜睡症社區收到的積極反饋令我們感到鼓舞。我和我們領導團隊的許多人都有幸與我們的現場人員一起出差，並與睡眠專家及其團隊進行第一手交談。考慮到我們在睡眠領域是一個相對較新的團隊，我們團隊的活力和睡眠專家的參與都非常出色。隨著我們的推出繼續，我們致力於繼續推動大批量羥丁酯處方者的需求，鼓勵患者倡導使用 LUMRYZ，確保付款人覆蓋並提供一流的患者服務和報銷支持。從發布團隊的角度來看，截至 7 月底，所有角色現已構建和培訓。八月，我們將迎來團隊全面部署的第一個月。我們繼續看到睡眠專家及其員工非常感興趣和參與。

Our sales team impact continues to grow and we have now engaged with the vast majority of the top of 1,600 prescribing offices that represent roughly 80% of total oxybate prescriptions. With the completion of our full team, we expect to continue to grow our reach and frequency to high-volume oxybate prescribers.

我們的銷售團隊影響力不斷擴大，目前我們已與 1,600 個處方辦事處中的絕大多數進行了合作，這些辦事處約佔羥丁酯處方總數的 80%。隨著我們整個團隊的完成，我們預計將繼續擴大我們對大劑量羥丁酯處方者的覆蓋範圍和頻率。

As a reminder, we see the oxybate market in 3 key segments. First, 1600 patients who are currently treated with twice-nightly first-generation oxybate. Second, around 16,000 patients from the last few years who have tried to discontinue the twice-nightly first-generation oxybate. And third, around 3,000 annual new patient starts who are naive to oxybate treatment from the greater than 25,000 who are eligible for, but have not yet been treated with an oxybate.

提醒一下，我們看到羥丁酸鹽市場分為三個關鍵領域。首先，1600 名患者目前每晚接受兩次第一代羥丁酯治療。其次，過去幾年約有 16,000 名患者嘗試停止每晚兩次的第一代羥丁藥物。第三，每年有大約 3,000 名新患者開始接受羥丁治療，而超過 25,000 名符合資格但尚未接受羥丁治療的患者中。

We have seen high interest from our target HCPs and people with our subsequent all 3 patient segments as evidenced by the greater than 1,000 REMS certifications for HCPs and greater than 400 RYZUP patient enrollments in the first 2 months of launch.

我們看到我們的目標HCP 和隨後所有3 個患者群體的人員都表現出了濃厚的興趣，推出後的前2 個月內超過1,000 名HCP 的REMS 認證和超過400 名RYZUP 患者註冊就證明了這一點。

For REMS, we are pleased to see the majority of certifications are coming from high-volume oxybate prescribers, although we have also had HCP certified who have never previously prescribed an oxybate as well. RYZUP patient enrollments have also been impressive as enrollment in this patient services program began the process for having a LUMRYZ prescription filled and delivered to a person with narcolepsy. Our data informs us that the majority of the greater than 400 RYZUP enrollments are switches from first-generation oxybate and that we are also getting patients naive to oxybate as well as previously discontinued oxybate patients.

對於 REMS，我們很高興看到大多數認證來自大劑量羥丁酯處方者，儘管我們也擁有以前從未開過羥丁酯處方的 HCP 認證。 RYZUP 患者註冊人數也令人印象深刻，因為該患者服務計劃的註冊開始了為發作性睡病患者配藥並交付 LUMRYZ 處方的過程。我們的數據告訴我們，超過 400 名 RYZUP 入組患者中的大多數是從第一代 oxybate 轉用的，我們還招募了未曾使用過 oxybate 的患者以及之前停止使用 oxybate 的患者。

For RYZUP, while our processes are similar to what most offices do already to prescribe specialty, REMS or controlled substances, systems and services can be viewed as different, and that is true for us with RYZUP. For example, we did extensive research to determine key services to offer through RYZUP, like our access and affordability programs, including a $0 commercial co-pay program for eligible patients. Our patient and temporary assistance program along with personalized RYZUP nurse care navigators individually assigned to each person with narcolepsy and their sleep specialists.

對於 RYZUP 來說，雖然我們的流程與大多數辦公室已經採取的開具專業處方、REMS 或受控物質的流程類似，但係統和服務可以被視為不同，對於 RYZUP 來說也是如此。例如，我們進行了廣泛的研究，以確定通過 RYZUP 提供的關鍵服務，例如我們的准入和負擔能力計劃，包括針對符合條件的患者的 0 美元商業自付費用計劃。我們的患者和臨時援助計劃以及個性化的 RYZUP 護士護理導航員分別分配給每個發作性睡病患者及其睡眠專家。

It's been really great to see both people with narcolepsy and HCPs take advantage of our services and for our nurse care navigators seeing them build relationships with the people they support. Before I provide a payer update, I'd like to summarize a few themes that from the time I've been in the field and from speaking with sleep specialists. First, we have yet to meet a sleep specialist who does not see a need for LUMRYZ. In general, it's actually quite the opposite where HCPs are really excited to learn about our once-at-bedtime sodium oxybate. Second, we encouraged to see some offices bringing several patients quickly, but we believe that most patients will visit their sleep specialist in their standard follow-up period, which is typically every 3 to 6 months. And third, sleep specialists are getting used to our RYZUP services, and they are trying them out to gain initial familiarity for themselves and their staff. Building a familiarity has been driven through our field reimbursement team who have been instrumental in educating offices on our services.

看到發作性睡病患者和 HCP 都利用我們的服務，並且我們的護士護理導航員看到他們與他們所支持的人建立關係，真是太棒了。在提供付款人最新消息之前，我想總結一下我在該領域工作以及與睡眠專家交談時得出的一些主題。首先，我們尚未遇到一位認為不需要 LUMRYZ 的睡眠專家。一般來說，情況實際上恰恰相反，HCP 非常興奮地了解我們的睡前一次羥丁酸鈉。其次，我們鼓勵一些診所快速接待多名患者，但我們相信大多數患者會在標準隨訪期內（通常每 3 至 6 個月一次）拜訪睡眠專家。第三，睡眠專家正在習慣我們的 RYZUP 服務，他們正在嘗試這些服務，以便自己和員工初步熟悉這些服務。我們的現場報銷團隊推動了人們對我們的熟悉，他們在對辦事處進行有關我們服務的教育方面發揮了重要作用。

Let me now transition to the payer front. We're really pleased with the progress we've made in achieving parity access with the first-generation oxybate. The LUMRYZ payer channel mix has been estimated to be about 80% to 90% commercial and the 3 GPOs; Ascent, Zinc and Emisar, collectively represent about 85% of those commercially covered lives. As a reminder, the LUMRYZ distribution network also includes all 3 specialty pharmacies from the GPO enterprises.

現在讓我轉到付款人方面。我們對在實現與第一代 oxybate 的平等獲取方面所取得的進展感到非常滿意。據估計，LUMRYZ 支付渠道組合的 80% 至 90% 是商業渠道和 3 個 GPO； Ascent、Zinc 和 Emisar 合計約佔商業承保生活的 85%。需要提醒的是，LUMRYZ 分銷網絡還包括 GPO 企業的全部 3 家專業藥房。

At Commercial Day, we announced the first of 3 GPO contracts had been finalized and signed as we secured Express Scripts coverage on the national Preferred formulary effective July 1. We have now been listened with the majority of sent PBM covered lives. And as Greg just mentioned, CVS Health has removed the new to market block for LUMRYZ on its commercially -- commercial formularies in a non-preferred position. Having secured the opportunity for commercial reimbursement in major PBMs from 2 of the 3 GPOs in the first 2 months of launch, in addition to the others previously announced from Kaiser and many of the Blue Cross Blue Shield plans, it is certainly a leading positive performance indicator and a reflection of the great work done by our market access team. Up to now, the majority of early prescriptions are being processed through medical necessity for which there is using more paperwork and more time required to navigate these prescriptions.

在商業日，我們宣布3 份GPO 合同中的第一份已經敲定並簽署，因為我們確保了Express Scripts 覆蓋全國首選處方集，並於7 月1 日生效。現在，大多數已發送的PBM 覆蓋生命已聽取了我們的意見。正如 Greg 剛才提到的，CVS Health 已經取消了 LUMRYZ 在其商業處方集上的非優先地位的新上市限制。除了Kaiser 之前宣布的其他計劃和許多Blue Cross Blue Shield 計劃之外，在推出的前2 個月內，我們還從3 個GPO 中的2 個獲得了主要PBM 的商業報銷機會，這無疑是領先的積極表現指標並反映了我們的市場准入團隊所做的出色工作。到目前為止，大多數早期處方都是根據醫療需要進行處理的，因此需要使用更多的文書工作和更多的時間來處理這些處方。

We announced at our Commercial Day that we are pleasantly surprised that in the first few weeks that we already had some reimbursed patients on LUMRYZ. And since then, we are -- have been extremely pleased to see the increasing reimbursement success our teams are having with LUMRYZ in the first couple of months of launch. And now with more commercial reimbursement for LUMRYZ that has been secured, we look forward to even more people with narcolepsy who will be able to access LUMRYZ in the future.

我們在商業日宣布，令我們驚喜的是，在最初幾週內，我們已經有一些 LUMRYZ 報銷患者。從那時起，我們非常高興地看到我們的團隊在 LUMRYZ 推出的頭幾個月內取得了越來越多的報銷成功。現在，隨著 LUMRYZ 獲得更多商業報銷，我們期待未來有更多嗜睡症患者能夠使用 LUMRYZ。

I covered a lot of ground today, and we believe that the early launch indicators have us well positioned to have a significant impact and are confident that we will be able to capture a significant portion of the large oxybate market opportunity. Our research shows us that the market opportunity for LUMRYZ could be much greater than that of current first-generation twice-nightly oxybate market, of about 16,000 patients on therapy with more than 50,000 potential eligible patients for LUMRYZ and a peak sales potential of greater than $1 billion. Although these are still the first couple of months of launch, we could not be prouder of the launch execution that our team is delivering and the receptivity we have received from the narcolepsy community. We look forward to providing more updates on future calls. And with that, I'll turn the call over to Jennifer for details on our current and our recent scientific data presentations. Jennifer?

我今天介紹了很多內容，我們相信早期發布的指標使我們處於有利位置，能夠產生重大影響，並且相信我們將能夠抓住大型羥丁酸鹽市場機會的很大一部分。我們的研究表明，LUMRYZ 的市場機會可能比當前第一代每晚兩次羥丁酯市場大得多，目前第一代每晚兩次羥丁酯市場約有16,000 名患者正在接受治療，其中有超過50,000 名潛在符合LUMRYZ 條件的患者，並且峰值銷售潛力大於10 億美元。儘管這仍然是發布的前幾個月，但我們對我們團隊正在交付的發布執行以及我們從嗜睡症社區獲得的接受度感到非常自豪。我們期待在未來的通話中提供更多更新。接下來，我會將電話轉給詹妮弗，了解我們當前和最近的科學數據演示的詳細信息。詹妮弗？

Thanks, Richard, and good morning. It's been a monumental quarter for us supporting the LUMRYZ's launch, along with our strong presence at Sleep 2023 and the publication of additional data that underscores the need for LUMRYZ. Starting with Sleep 2023, we were incredibly pleased we have delivered a leading clinical presence of 12 posters in 6 oral presentations, which collectively support the strong LUMRYZ clinical profile and insight into patient needs. For example, data from a social network study showed that more than 60% of people with narcolepsy consider among their most troubling symptoms, various sleep disturbances, including core quality sleep, disrupted nighttime sleep, fragmented sleep and insomnia.

謝謝理查德，早上好。對於我們支持 LUMRYZ 的推出、我們在 Sleep 2023 的強勢亮相以及強調 LUMRYZ 需求的其他數據的發布來說，這是一個具有里程碑意義的季度。從 Sleep 2023 開始，我們非常高興能夠在 6 場口頭演講中提供 12 張海報的領先臨床展示，這些海報共同支持了強大的 LUMRYZ 臨床概況和對患者需求的洞察。例如，來自社交網絡研究的數據顯示，超過 60% 的發作性睡病患者認為最令人不安的症狀是各種睡眠障礙，包括核心質量睡眠、夜間睡眠中斷、睡眠碎片和失眠。

Among all the narcolepsy treatments, only LUMRYZ does not cause insomnia or require chronic middle-of-the-night dosing. Once again, we presented ongoing data from RESTORE, the open-label study, which has now been underway for more than 3 years and continues to bolster the known safety and tolerability profile of LUMRYZ. Most importantly, 94% of those switching from twice-nightly oxybate preferred the once-nightly dosing regimen.

在所有發作性睡病治療中，只有 LUMRYZ 不會引起失眠或需要長期半夜服藥。我們再次展示了來自開放標籤研究 RESTORE 的持續數據，該研究現已進行了 3 年多，並繼續增強 LUMRYZ 已知的安全性和耐受性。最重要的是，94% 的從每晚兩次 oxybate 轉為每晚一次的給藥方案的人更喜歡每晚一次的給藥方案。

Turning to 2 new peer-reviewed publications. First, we published in sleep a post-hoc analysis of LUMRYZ's REST-ON data divided by narcolepsy type. No published data previously existed prospectively evaluating oxybate treatment on in T2 or narcolepsy without cataplexy. We have demonstrated a consistent efficacy profile for LUMRYZ in both T1 and in T2. These data are important as there is a perception of some sleep clinicians and patients that oxybate should be reserved for in T1. With this publication, we have the clinical study data to show favorable efficacy in T2 as well.

轉向 2 份新的同行評審出版物。首先，我們在睡眠中發表了 LUMRYZ 的 REST-ON 數據按發作性睡病類型劃分的事後分析。先前沒有發表的數據前瞻性地評估羥丁酯治療 T2 或不伴猝倒的發作性睡病。我們已經證明 LUMRYZ 在 T1 和 T2 中具有一致的療效。這些數據很重要，因為一些睡眠臨床醫生和患者認為羥丁應保留在 T1 中。通過這篇文章，我們獲得了臨床研究數據，表明 T2 期也具有良好的療效。

Lastly, we published a new discrete choice experiment in advances in therapy. As you may recall, we previously published a DCE among patients showing that the #1 driver of sodium oxybate preference is the dosing regimen with non-preference identified for a single bedtime dose. We followed up with the second DCE this time among 100 clinicians and included sodium content as an attribute to get that. The once-nightly dosing which only LUMRYZ provides was more than twice as important for overall oxybate choice than the next 2 attributes, which were adverse reactions and sodium content, respectively. Our scientific data aligns with what we are now seeing in the real world. LUMRYZ is fulfilling a significant unmet need. I will now turn the call over to Tom for an update on the company's financials. Tom?

最後，我們發表了一項關於治療進展的新離散選擇實驗。您可能還記得，我們之前在患者中發表的 DCE 表明，羥丁酸鈉偏好的第一大驅動因素是劑量方案，而單次睡前劑量則確定為非偏好。這次我們對 100 名臨床醫生進行了第二次 DCE 跟踪，並將鈉含量作為一個屬性來獲得。僅 LUMRYZ 提供的每晚一次給藥對於整體羥丁酸選擇的重要性是接下來的兩個屬性（分別是不良反應和鈉含量）的兩倍多。我們的科學數據與我們現在在現實世界中看到的情況一致。 LUMRYZ 正在滿足一項重大的未滿足需求。我現在將把電話轉給湯姆，詢問公司財務狀況的最新情況。湯姆？

Thank you, Jennifer. We are pleased to announce that we generated our first sales of LUMRYZ and reported $1.5 million of net revenue for the quarter ended June 30, 2023, which represents initial stocking orders from all 3 of the specialty pharmacies in our distribution network. And while we are not providing revenue guidance at this time, I can share that subsequent to June 30, we generated additional sales from all 3 of the specialty pharmacies as the launch of LUMRYZ has progressed. We also reported a total of $51 million of GAAP operating expenses during the quarter ended June 30, 2023, which is comprised of approximately $47 million of SG&A costs and $4 million of R&D costs.

謝謝你，詹妮弗。我們很高興地宣布，我們實現了 LUMRYZ 的首次銷售，並報告了截至 2023 年 6 月 30 日的季度淨收入 150 萬美元，這代表了我們分銷網絡中所有 3 家專業藥房的初始庫存訂單。雖然我們目前沒有提供收入指導，但我可以分享的是，在 6 月 30 日之後，隨著 LUMRYZ 的推出取得進展，我們從所有 3 家專業藥房獲得了額外的銷售額。我們還報告了截至 2023 年 6 月 30 日的季度的 GAAP 運營費用總計 5100 萬美元，其中包括約 4700 萬美元的 SG&A 成本和 400 萬美元的研發成本。

I want to highlight approximately $18 million of expenses that impacted the quarter that drove OpEx higher than what we expect our cash operating expenses will be on a go-forward basis. First, there was approximately $9 million of noncash expenses, the majority of which is tied to stock-based compensation, which includes a cumulative catch-up adjustment of $6 million for previously granted equity awards. The $6 million cumulative catch-up adjustment was recorded upon reaching the milestone objective of our first commercial sale of LUMRYZ. Second, there was also a cumulative catch-up adjustment of approximately $2 million for cash incentive awards that were tied to reaching the same milestone.

我想強調的是，影響本季度的約 1800 萬美元的支出導致運營支出高於我們預期的未來現金運營支出。首先，大約有 900 萬美元的非現金支出，其中大部分與股票薪酬相關，其中包括先前授予的股權獎勵的 600 萬美元的累計追趕調整。 600 萬美元的累計追趕調整是在達到 LUMRYZ 首次商業銷售的里程碑目標後記錄的。其次，還對與達到同一里程碑相關的現金獎勵進行了約 200 萬美元的累計追趕調整。

Third, we incurred approximately $5 million of legal and other professional fees of which $3 million were contingent on receiving FDA approval and launching LUMRYZ. And finally, we expensed approximately $2 million of commercial LUMRYZ inventory through R&D that was purchased prior to receiving FDA approval. Post FDA approval, commercial inventory purchases will be capitalized and expensed through cost of products sold. After adjusting for these items, cash operating expenses in the quarter ended June 30, 2023, were approximately $33 million. And we expect that quarterly cash operating expenses for the remainder of 2023 will be in the range of $35 million to $40 million.

第三，我們產生了大約 500 萬美元的法律和其他專業費用，其中 300 萬美元取決於獲得 FDA 批准和推出 LUMRYZ。最後，我們通過研發支出了大約 200 萬美元的商業 LUMRYZ 庫存，這些庫存是在獲得 FDA 批准之前購買的。 FDA 批准後，商業庫存採購將資本化併計入銷售產品成本。對這些項目進行調整後，截至 2023 年 6 月 30 日的季度現金運營支出約為 3300 萬美元。我們預計 2023 年剩餘時間的季度現金運營支出將在 3500 萬美元至 4000 萬美元之間。

Finally, just a few comments on the balance sheet. During the quarter ended June 30, 2023, we completed the exchange of $106.3 million convertible notes for 12.3 million common shares. Effective with this exchange, we have just $21.2 million of convertible notes remaining, which matures in October of 2023, and our intent is to sell the principal and interest in cash. And I'll wrap up with our cash position. At June 30, we had approximately $161 million of cash, cash equivalents and marketable securities. In addition to that, last week, we received $30 million from the first tranche of the $75 million royalty financing commitment we secured earlier this year. A second tranche of $45 million remains committed from the royalty financing is available if we achieve $25 million of quarterly net revenue by June 30, 2024.

最後，對資產負債表進行一些評論。在截至 2023 年 6 月 30 日的季度中，我們完成了 1.063 億美元可轉換票據與 1,230 萬股普通股的交換。自此次交換生效後，我們只剩下 2120 萬美元的可轉換票據，將於 2023 年 10 月到期，我們的目的是以現金出售本金和利息。我將結束我們的現金狀況。截至 6 月 30 日，我們擁有約 1.61 億美元的現金、現金等價物和有價證券。除此之外，上週我們從今年早些時候獲得的 7500 萬美元特許權使用費融資承諾的第一筆中收到了 3000 萬美元。如果我們在 2024 年 6 月 30 日之前實現 2500 萬美元的季度淨收入，則仍可從特許權使用費融資中獲得第二筆 4500 萬美元的承諾。

But as a reminder, we are not required to drive $45 million in the royalty. We believe, based on current plans and expectations that cash on hand at June 30 plus the $30 million from the royalty financing and expected cash receipts from sales of LUMRYZ are sufficient to support the launch of LUMRYZ and bridge the company to cash flow breakeven.

但提醒一下，我們不需要收取 4500 萬美元的特許權使用費。我們認為，根據目前的計劃和預期，截至6 月30 日的手頭現金加上來自特許權使用費融資的3000 萬美元以及LUMRYZ 銷售的預期現金收入足以支持LUMRYZ 的推出並使公司實現現金流收支平衡。

For additional detail on our financial results for the quarter ended June 30, 2023, please refer to the 10-Q or the press release issued earlier this morning. And I'll now turn the call back to Greg for closing remarks.

有關我們截至 2023 年 6 月 30 日的季度財務業績的更多詳細信息，請參閱 10-Q 或今天上午發布的新聞稿。現在我將把電話轉回給格雷格，讓他作結束語。

Thank you, Tom. We believe our strong foundation has supported our successful initial and very early launch of LUMRYZ and we remain laser-focused on continuing to execute the commercial launch. We believe we've made significant progress in this area and look forward to potentially expanding our pipeline to reach more patients in the future. We're excited to be in the field and actively changing the treatment paradigm for patients and are fully committed to realizing the value of LUMRYZ, which we believe has the potential to achieve peak sales greater than $1 billion. We thank you for your support and look forward to providing future updates on our progress. And with that, let's open up the call for questions. Operator?

謝謝你，湯姆。我們相信，我們強大的基礎支持了 LUMRYZ 最初和早期的成功推出，並且我們仍然專注於繼續執行商業發布。我們相信我們已經在這一領域取得了重大進展，並期待著未來能夠擴大我們的產品線以覆蓋更多患者。我們很高興能夠進入該領域並積極改變患者的治療模式，並完全致力於實現 LUMRYZ 的價值，我們相信 LUMRYZ 有潛力實現超過 10 億美元的峰值銷售額。我們感謝您的支持，並期待在未來提供有關我們進展的最新信息。接下來，讓我們開始提問。操作員？

(Operator Instructions). Our first question comes from François Brisebois with Oppenheimer.

（操作員說明）。我們的第一個問題來自弗朗索瓦·布里斯布瓦和奧本海默。

Congrats on the progress here. So the first one, I just want to better understand RYZUP and just that metric, you have 400 -- sorry, yes, 400 from the 1/4 that you had shared previously. I just want to understand how should we think about those numbers and how they correlate to ultimately sales?

恭喜這裡取得的進展。所以第一個，我只是想更好地理解 RYZUP 和這個指標，你有 400——抱歉，是的，從你之前分享的 1/4 中得到了 400。我只是想了解我們應該如何看待這些數字以及它們與最終銷售額有何關聯？

Yes. Thanks, Frank. Richard, do you want to talk about that?

是的。謝謝，弗蘭克。理查德，你想談談這個嗎？

Yes, sure. Frank, thanks for the question. So first, we're super pleased with the progress that we've been making so far. And although we're not providing specific guidance, what we are doing right now is, it's hard to predict exactly how many of those patients will convert into sales. But what we can say, and as I mentioned in our prepared remarks is, we have been really having increased success in getting reimbursement. In fact, one of the things I can mention as well is we're probably not using our temporary assistance programs as much as we thought early on. So although it's difficult to predict how many of those patients will convert, what I can say is no one has more motivated than us to get those patients on to product -- to LUMRYZ fulfilled for them as well.

是的，當然。弗蘭克，謝謝你的提問。首先，我們對迄今為止所取得的進展感到非常滿意。儘管我們沒有提供具體的指導，但我們現在正在做的是，很難準確預測其中有多少患者會轉化為銷售。但我們可以說，正如我在準備好的發言中提到的那樣，我們在獲得報銷方面確實取得了更大的成功。事實上，我還可以提到的一件事是，我們可能沒有像我們早期想像的那樣使用臨時援助計劃。因此，儘管很難預測其中有多少患者會轉變，但我可以說的是，沒有人比我們更有動力讓這些患者使用產品 - LUMRYZ 也為他們提供了滿足。

Great. And then in terms of -- are you ever going to share the average number or exit number of patients that are on drug? Or should we expect these metrics to be the metrics going forward? And then just maybe a quick comment on the CVS news. Is that earlier than expected or kind of in line here?

偉大的。然後，您是否打算分享接受藥物治療的患者的平均人數或退出人數？或者我們是否應該期望這些指標成為未來的指標？然後可能是對 CVS 新聞的簡短評論。是比預期早還是有點符合預期？

Yes. On the metrics, again, as we shared back in the Commercial Day, we believe during these first few months, the most important leading indicators for us were REMS certifications, RYZUP enrollments and reimbursement because those all feed into ultimately converting someone into a paid drug. We absolutely agree that as we go forward and in future quarters, reporting patients on therapy is an important metric, right? And as Richard noted, and as what we said back in June, we were pleased just in the first month to see some patients already convert in a much sooner way than we thought. We've only seen that accelerate. And we've -- as Richard noted, we haven't been required or necessary to use our temporary assistance programs as much as we thought we may need.

是的。就指標而言，正如我們在商業日分享的那樣，我們相信在最初的幾個月裡，對我們來說最重要的領先指標是REMS 認證、RYZUP 註冊和報銷，因為這些都有助於最終將某人轉變為付費藥物。我們完全同意，隨著我們的前進和未來幾個季度，報告患者的治療情況是一個重要的指標，對吧？正如理查德所指出的，正如我們在六月份所說的那樣，我們很高興在第一個月就看到一些患者已經以比我們想像的更快的方式轉變。我們只看到了這種加速。正如理查德指出的那樣，我們沒有被要求或沒有必要使用我們認為可能需要的那麼多臨時援助計劃。

So again, I think everything from our perspective is on track, and that will be a metric as we get -- go forward we certainly will report. And I'll just remind you that we're 2 months into the launch, and this is our second update, and we haven't had our first full quarter yet. So again, I think you'll see those data points start coming out in the future. In terms of your comments on CVS, Richard, is that on course and timing-wise are earlier than what we may have thought with, Richard, feel free to answer.

再說一次，我認為從我們的角度來看，一切都步入正軌，這將是我們得到的一個指標——繼續前進，我們肯定會報告。我只是提醒您，我們已經發布了 2 個月，這是我們的第二次更新，我們還沒有完成第一個完整的季度。再說一遍，我認為您將來會看到這些數據點開始出現。理查德，就您對 CVS 的評論而言，在路線和時間上都比我們想像的要早，理查德，請隨意回答。

Yes. We're thrilled to actually have 2 significant payer reimbursement wins as early on 2 months post launch. It's really been impressive to see. I think it's a real testament to the work that both our medical and our market access team have been explaining the proposition of LUMRYZ to the payers and clearly them sort of seeing our value proposition and great negotiations. So the fact that we have 2 big wins already this quickly amongst many other smaller ones is a real testament to sort of the early performance from our team.

是的。我們很高興在發布後 2 個月內就贏得了 2 筆重大付款人報銷。看到這確實令人印象深刻。我認為，我們的醫療和市場准入團隊一直在向付款人解釋 LUMRYZ 的主張，並且顯然他們看到了我們的價值主張和良好的談判，這真正證明了我們的工作。因此，我們在許多其他較小的勝利中這麼快就取得了兩次重大勝利，這一事實真正證明了我們團隊的早期表現。

Our next question comes from Andrew Tsai with Jefferies.

我們的下一個問題來自 Jefferies 的 Andrew Tsai。

Congrats on the progress. I appreciate the updates and thanks for taking our questions. Appreciating you do not necessarily want to share too much, but I'll try to ask in another way. Of the 140 patients who have signed up as of June and how many of them have been converted to a treated patients just so we can gauge the speed as well as the depth of conversions? And secondly, can you just also remind us how many patients remain in your open-label study right now? And when could they start rolling over to being a commercial patient. And if they were to be rolled over, would they be counted as a new patient in RYZUP? Or would they automatically be classified as a treated patient?

祝賀取得的進展。我感謝您的更新並感謝您提出我們的問題。欣賞你不一定要分享太多，但我會嘗試用另一種方式來詢問。截至 6 月，已註冊的 140 名患者中，有多少人已經轉變為接受治療的患者，這樣我們就可以衡量轉變的速度和深度？其次，您能否提醒我們目前還有多少患者參與您的開放標籤研究？他們什麼時候可以開始轉為商業患者。如果他們要轉期，他們會被算作 RYZUP 的新患者嗎？或者他們會自動被歸類為已接受治療的患者嗎？

Yes. Thanks, Andrew. Again, I think we're early into the launch and the specific metric around actual patients on therapy will be something we talk about in subsequent quarters. We're very focused on the leading indicators into that, and we've made great progress there. I would say that we've seen -- what we noted at the end of June was we were pleasantly surprised, again, to see patients begin to get reimbursed in a fairly efficient way and go on commercial drug. And again, in July, that's only accelerated. And in many ways, and Richard, you can comment, it's just these patients take some time. So the earlier patients are likely the ones converting sooner unless you are converting -- unless you're in a benefit design that adjudicates fairly quickly.

是的。謝謝，安德魯。再說一次，我認為我們還處於啟動初期，圍繞實際接受治療的患者的具體指標將是我們在接下來的幾個季度中討論的內容。我們非常關注這方面的領先指標，並且我們已經在這方面取得了巨大進展。我想說的是，我們已經看到——我們在六月底注意到的是，我們再次驚喜地看到患者開始以相當有效的方式獲得報銷並繼續使用商業藥物。到了 7 月份，這種情況再次加速。在很多方面，理查德，你可以評論，只是這些病人需要一些時間。因此，較早的患者可能會較早轉變，除非您正在轉變 - 除非您採用的福利設計可以相當快地做出裁決。

And we have a few of those for sure. But I think what you're seeing is the time that requires to move from the top of the funnel, which is what we'll characterize RYZUP is to out as a dispense takes time navigating the medical necessity process until these more formal coverage policy decisions begin to take hold. But at this point, I would say we're very pleased with how we're seeing that conversion occur even back to the 140 versus what we had assumed and perhaps equally as important is the lack -- the less dependency on what we call our temporary assistance program, which you may refer to as some sort of bridging our free drug program, but not being required to use that at a level that we had assumed because of the team's ability to navigate the reimbursement process. In terms of your open-label question, as we previously talked about, we had a little under 100 who were still in the trial at the time, I would say of the RYZUP enrollment, they represent a very small minority today.

我們肯定有一些。但我認為您所看到的是從漏斗頂部移動所需的時間，這就是我們將RYZUP 描述為要解決的問題，因為配發需要時間來完成醫療必要性流程，直到做出更正式的承保政策決定開始佔據上風。但在這一點上，我想說，我們對看到轉換甚至回到140 與我們假設的情況相比感到非常高興，也許同樣重要的是缺乏——對我們所謂的“我們的”的依賴更少。臨時援助計劃，您可以將其稱為某種橋接我們的免費藥物計劃，但由於團隊有能力完成報銷流程，因此不需要在我們假設的水平上使用該計劃。就您的開放標籤問題而言，正如我們之前談到的，我們當時仍在試驗中的人數不到 100 人，我想說的是 RYZUP 註冊人數，他們今天只佔很小的少數。

They are being processed into the system. They would count technically as a new RYZUP enrollment because it's independent of that. We've seen some of those already transition into commercial drug. But I would say that, that's in the works now and with a whole lot more to actually process through and ultimately move on to commercial drug.

它們正在被處理到系統中。從技術上講，他們將算作新的 RYZUP 註冊，因為它與此無關。我們已經看到其中一些已經轉變為商業藥物。但我想說的是，現在正在進行中，還有很多工作需要實際處理並最終轉向商業藥物。

Our next question comes from Ami Fadia with Needham & Company.

我們的下一個問題來自 Needham & Company 的 Ami Fadia。

I guess I'm going to try to understand that same metric in a slightly different way. Can you talk about what are the steps that are required from the time the patient gets enrolled in the RYZUP hub and goes through all the steps before they can start to receive drug and at which point do you need to make the decision of whether you want to support that patient with the drug? If you could sort of talk to that process? And all the patients that are receiving drug today, what percent are receiving free drug? That would be helpful.

我想我將嘗試以稍微不同的方式理解相同的指標。您能否談談從患者加入 RYZUP 中心並完成所有步驟之後才能開始接受藥物開始需要執行哪些步驟，以及您需要在什麼時候做出是否想要的決定用藥物支持該患者？您能談談這個過程嗎？今天接受藥物治療的所有患者中，有多少百分比接受免費藥物？那會有幫助的。

Yes. So Richard, do you want to take those?

是的。理查德，你想拿走那些嗎？

Yes, sure. Thanks for the question, Ami. So I always remind myself that getting a new specialty product to a patient early in launch is just -- it's complicated for any product launch, right? And that's why we're really overinvested in our services through RYZUP (inaudible) reimbursement team. So the general process is this, you have to sit in a RYZUP enrollment form that will begin the process. Sometimes, the information is complete and sometimes, it isn't. Benefits investigation will begin. We'll start to identify -- RYZUP will identify which specialty pharmacy is used. That will be done and then a prescription will be set in that can now go through the process. But especially before any criteria is set for prioritization from a payer, it generally is going to go through medical necessity, which is a much more manual process where an office has to write specific reasons why they're looking to use this product.

是的，當然。謝謝你的提問，阿米。因此，我總是提醒自己，在發布初期向患者提供新的專業產品對於任何產品發布來說都是很複雜的，對吧？這就是為什麼我們通過 RYZUP（聽不清）報銷團隊對我們的服務進行了過度投資。一般流程是這樣的，您必須填寫 RYZUP 註冊表格才能開始該流程。有時，信息是完整的，有時則不是。福利調查將開始。我們將開始確定 — RYZUP 將確定使用的是哪家專業藥房。這將完成，然後將製定一個處方，現在可以完成該過程。但特別是在付款人設定任何優先級標準之前，通常會經過醫療必要性，這是一個更加手動的過程，辦公室必須寫下他們希望使用該產品的具體原因。

It goes to the payer, goes back and forth a couple of times. So the point is it takes a while. Once that is approved, then, of course, the pharmacy has to line up when that prescription will actually be fulfilled. So prior to any coverage decisions being made through medical necessity, this takes well over a month for those things to happen in general. So we're not measuring in a few days or a few weeks, but definitely several weeks. And that's why getting some of these reimbursement wins with the payers is so important because that should decrease the time of sort of going through the process as well. So we're super pleased with how it's working because it is complicated. But at the same time, as Greg and I have mentioned, we're also super pleased to sort of see the level of reimbursement that we're getting.

它發送給付款人，來回幾次。所以重點是這需要一段時間。一旦獲得批准，那麼，當然，藥房必須在處方真正得到滿足時排隊。因此，在出於醫療需要做出任何承保決定之前，這些事情通常需要一個多月的時間才能發生。因此，我們不是在幾天或幾週內進行測量，而是在幾週內進行測量。這就是為什麼與付款人取得一些報銷勝利如此重要，因為這也應該減少完成整個過程的時間。所以我們對它的工作方式非常滿意，因為它很複雜。但與此同時，正如格雷格和我提到的，我們也非常高興看到我們得到的報銷水平。

And to your point, I won't comment on the percentage of free product, but what is -- what we're seeing is a lot more reimbursement wins than we had expected or projected at least. And in general, the decision about when someone goes on to our temporary assistance program, it's really the decision between the patient and the provider. Because oftentimes, if they're existing switch patients, they will have other product ready or there's other things going in their life. So it is there to be offered, but a lot of times, the decision of the patient and the provider, that's what we listen to and figure out when should we kick in a lot of these programs as well. And the last comment I can give is we actually have had drugs that we are about to administer through our temporary systems program, where we did get approval for reimbursement right before we are about to send it out as well. So this is a very dynamic period of launch. And like I said, we're just really excited that, a, we're getting patients onto LUMRYZ, and b, we're getting more reimbursement success than maybe we had first anticipated.

就你的觀點而言，我不會評論免費產品的百分比，但我們所看到的報銷勝利至少比我們預期或預計的要多得多。一般來說，關於某人何時繼續參加我們的臨時援助計劃的決定實際上是患者和提供者之間的決定。因為通常情況下，如果他們是現有的轉換患者，他們會準備好其他產品，或者他們的生活中有其他事情發生。因此，它是可以提供的，但很多時候，患者和提供者的決定，這就是我們傾聽的內容，並弄清楚我們何時應該啟動許多這些計劃。我能給出的最後一條評論是，我們實際上已經擁有了即將通過臨時系統計劃管理的藥物，在我們即將發出藥物之前，我們確實獲得了報銷批准。所以這是一個非常活躍的啟動時期。就像我說的，我們真的很興奮，a，我們讓患者使用 LUMRYZ，b，我們獲得比我們最初預期更多的報銷成功。

Maybe a follow-up to that, which is just to sort of understand how you guys are trying to make sure that you don't lose these patients while some of these steps are being undertaken. It's good to see that over 400 patients are enrolled in RYZUP, but what I'm trying to understand is are those going to eventually convert into patients on drug? Or is there -- is it like that a percentage of those patients will maybe get lost through the process, either because the process was taking time or at some point, the patient changes their mind or what drug they want to be on?

也許是後續行動，這只是為了了解你們在採取其中一些步驟時如何努力確保不會失去這些患者。很高興看到超過 400 名患者參加了 RYZUP，但我想了解的是，這些患者最終會轉變為接受藥物治療的患者嗎？或者是否存在——這些患者中的一部分可能會在這個過程中迷失方向，要么是因為這個過程需要時間，要么是在某個時刻，患者改變了主意或他們想要服用什麼藥物？

Yes. Ami, it's a great question. Unfortunately, for any product that's prescribed in the United States, there is abandonment that goes on from either the provider or the patient. Once again, that's why we invested as much as we did into our RYZUP services. Our nurse care navigators have individual relationships with both patients and with the office because that communication -- I think where people struggle the most is when they don't know what's going on. And that's why our nurse care navigators really take the time to invest in the relationship, follow up with those patients as well. So they understand where they are in their process. So it's really hard to sort of say what percent will stay on right now. But what we can say is that's why we really invested as much as we did into our services because holding patients and offices, especially early on is so important so that they have a good experience and likely -- are more likely to stay in the process, didn't want to give up as well.

是的。阿米，這是一個很好的問題。不幸的是，對於在美國開出的任何產品，供應商或患者都會放棄。這也是我們在 RYZUP 服務上投入如此多資金的原因。我們的護士護理導航員與患者和辦公室都有個人關係，因為這種溝通——我認為人們最困難的地方是當他們不知道發生了什麼時。這就是為什麼我們的護士護理導航員真正花時間投資於這種關係，並對這些患者進行跟進。所以他們了解自己在流程中所處的位置。所以現在很難說有多少百分比會留下來。但我們可以說的是，這就是為什麼我們真正在服務上投入了那麼多，因為保留患者和辦公室，尤其是早期非常重要，這樣他們就有了良好的體驗，並且更有可能留在這個過程中，也不想放棄。

Yes. The only thing I would add is that we've built our programs to support patients at any point along this process. We're prepared to initiate our temporary systems program as early as that patient and provider wants. The good news for us -- and that's what we assumed was going to be happening. The good news for us is that, that's not what's happened. We've been able to keep them on, and no one is more incentivized to keep them in that kind of system than us to keep them on and through the process and getting to a reimbursed product without having to use our temporary assistance program at a much, much lower rate than what we had originally assumed.

是的。我唯一要補充的是，我們已經制定了我們的計劃，以便在此過程中的任何時候為患者提供支持。我們準備按照患者和提供者的要求儘早啟動我們的臨時系統計劃。這對我們來說是個好消息——這就是我們認為將會發生的事情。對我們來說，好消息是，事實並非如此。我們已經能夠將它們保留在這種系統中，沒有人比我們更願意將它們保留在這種系統中，並在整個過程中保留它們，並在無需使用我們的臨時援助計劃的情況下獲得報銷產品。比我們最初假設的要低得多。

Our next question comes from Marc Goodman with Leerink.

我們的下一個問題來自馬克·古德曼和 Leerink。

First, anecdotal stories that your reps are talking about just what's going on in the marketplace? Just you've got generics out there for Xywav, how Xywav is doing to taking share, obviously. Just any stories that you're hearing out there? And secondly, Tom, can you talk about what are sales that are needed to break even for the company?

首先，您的代表正在談論市場上正在發生的事情？只是你已經有了 Xywav 的仿製藥，顯然 Xywav 是如何占據份額的。你在那裡聽到過什麼故事嗎？其次，湯姆，你能談談公司需要多少銷售額才能實現收支平衡嗎？

Richard, do you want to start?

理查德，你想開始嗎？

Yes, Marc, thanks. Anecdotes are awesome, and that's why also getting the field has been terrific. Overall, what I can sort of say is there's been just really great receptivity from the offices that we have been in. Maybe a couple -- one anecdote I will also share that's happened several times across the country is, we're a relatively new company. And our representatives go speak to the receptionist and they don't know the doctor yet. And believe they will call. They come back in a few weeks. And then we've had doctors literally call or chase our reps in the parking lot and sort of say, "Can you please come in if you've got that once-at-bedtime therapy." So I think it's just been really cool to see. Clearly, we're in a very competitive marketplace. But we have a very clear strategy. We have very clear messaging. And we really think the conversations have been great. So thus far, I think it's been really a thrill and an honor to be out there. And there's a lot of energy from our team because the receptivity from the sleep specialist offices has been great. And I guess, we'll turn the next question over to Tom.

是的，馬克，謝謝。軼事很棒，這就是為什麼獲得這個領域也很棒。總的來說，我可以說的是，我們所在的辦公室的接受度非常高。也許有一些——我也將分享一個在全國各地發生過多次的軼事，我們是一個相對較新的公司公司。我們的代表去與接待員交談，但他們還不認識醫生。並相信他們會打電話。他們幾週後回來。然後我們讓醫生在停車場打電話或追趕我們的代表，並說：“如果您接受了睡前一次治療，可以進來嗎？”所以我認為看到它真的很酷。顯然，我們正處於一個競爭非常激烈的市場。但我們有一個非常明確的戰略。我們有非常明確的信息。我們真的認為對話非常精彩。到目前為止，我認為能夠來到這裡真是令人興奮和榮幸。我們的團隊充滿活力，因為睡眠專家辦公室的接待能力非常好。我想，我們將把下一個問題交給湯姆。

Marc, thanks for the question. I think rather than thinking about it in terms of sales, which of course, I understand your question, I think about it in terms of paid patients on therapy. If I use what I described as our expected cash run rate of $35 million to $40 million per quarter, you've annualized that. You think about a number of patients -- paid patients on therapy of something in the range of about 1,500 patients. At that level, we're probably (inaudible) the sales required to achieve breakeven profitability.

馬克，謝謝你的提問。我認為，與其從銷售角度考慮，當然，我理解你的問題，我從付費治療患者的角度考慮。如果我使用我所描述的每季度 3500 萬至 4000 萬美元的預期現金運行率，那麼您就已經將其年化了。想想一些病人——付費接受治療的病人大約有 1,500 名。在這個水平上，我們可能（聽不清）實現盈虧平衡盈利所需的銷售額。

Our next question comes from David Amsellem with Piper Sandler.

我們的下一個問題來自 David Amsellem 和 Piper Sandler。

This is Kyle on for David. Just a couple of questions. First, realizing it's still early, but just based on some early feedback, can you comment on the patient types where you've seen the most actual uptake or demand so far. Whether those are patients that are currently on twice-nightly oxybate? Would you just prefer the once-nightly or have been on twice-nightly in the past or oxybate naive? And then in terms of the payer landscape, I'm wondering what your current expectations are for whether any plans or making patients step through generic oxybate or if you're expecting that in the future?

這是大衛的凱爾。只是幾個問題。首先，意識到現在還為時過早，但僅根據一些早期反饋，您能否評論一下迄今為止您所看到的最實際採用或需求的患者類型。這些是否是目前每晚服用兩次羥丁藥物的患者？您會選擇每晚一次還是過去每晚兩次，還是天真地服用 oxybate？然後就付款人情況而言，我想知道您目前對是否有任何計劃或讓患者逐步使用非專利羥丁酸的期望是什麼，或者您是否對未來有這樣的期望？

Richard, do you want to -- those are for you?

理查德，你想——那些是給你的嗎？

No problem. Thanks for the question. So as far as the patient types we're sort of seeing coming into RYZUP, the majority thus far are patients who are currently on a first-generation twice-nightly oxybate. However, we are also seeing patients who are naive to oxybate and also patients who have previously discontinued. So a nice mix overall, but the majority thus far are patients who were previously on -- or sorry, currently were switching from a first-generation oxybate. And as far as your second question is concerned, our whole strategy has been to get parity access with the best of the first-generation oxybate. Thus far, we are not seeing any impact for a step through a generic for LUMRYZ. Our strategy has been for that not to happen. So -- and thus far, the plans that we have been listed with do not require a step to go through any oxybate prior to us as well. So that's really our strategy, is to really make sure that the payer we're not disadvantaged through a payer perspective, from an oxybate access and we're really focused on sort of the communications and what we do in the offices with the sleep specialist as well.

沒問題。謝謝你的提問。因此，就我們看到的進入 RYZUP 的患者類型而言，到目前為止，大多數是目前正在接受第一代每晚兩次羥丁治療的患者。然而，我們也看到未接受過羥丁治療的患者以及之前已停藥的患者。總體而言，這是一個很好的組合，但到目前為止，大多數患者都是以前使用過的患者，或者抱歉，目前正在從第一代羥丁酸轉換而來。就你的第二個問題而言，我們的整個策略是獲得與第一代羥丁酸鹽中最好的產品同等的機會。到目前為止，我們還沒有看到 LUMRYZ 仿製藥的一步產生任何影響。我們的策略是避免這種情況發生。因此，到目前為止，我們列出的計劃也不需要在我們之前進行任何氧化處理。因此，這確實是我們的策略，是真正確保付款人從付款人的角度、從氧酸鹽訪問角度不會處於不利地位，我們真正關注的是溝通以及我們在辦公室與睡眠專家所做的事情以及。

Great. That's helpful. And if I could just ask one more. Just how are you thinking about the opportunity for LUMRYZ in IH? Do you think that a once-nightly option is more suited to this population? Do you have any thoughts on that?

偉大的。這很有幫助。如果我能再問一個問題就好了。您如何看待 LUMRYZ 在 IH 的機會？您認為每晚一次的選擇更適合這一人群嗎？您對此有什麼想法嗎？

Richard, do you have any commentary? And then maybe, Jen?

理查德，你有什麼評論嗎？那麼也許，珍？

Yes. For IH, through our ad boards and speaking to our top specialists, the general feedback we receive is as strong as our value proposition is in narcolepsy for LUMRYZ. It may even be slightly stronger in IH, especially when you consider the sleep inertia that patients with IH have and sometimes their inability to wake up and take their medication or another dose. So I think there's a lot of interest in that, and that's why we have been spending collective time really looking at the opportunity to get our clinical program going. But Jen, anything you'd like to add?

是的。對於 IH 來說，通過我們的廣告板以及與頂級專家的交談，我們收到的總體反饋與我們在嗜睡症領域對 LUMRYZ 的價值主張一樣強烈。 IH 患者的睡眠惰性甚至可能稍強，尤其是考慮到 IH 患者的睡眠慣性，有時他們無法醒來並服用藥物或其他劑量。所以我認為大家對此很感興趣，這就是為什麼我們一直在花集體時間真正尋找讓我們的臨床計劃繼續下去的機會。但是 Jen，你還有什麼要補充的嗎？

I'll just emphasize what you mentioned, Richard, and that is the sleep inertia. That is the reason with the twice-nightly formulation, they allowed for once-nightly dose up to 6 grams because patients simply could not wake up to take the second dose, but it is really important to note that you could only go to 6 grams, and that is subtherapeutic for a number of patients. And so we certainly hear through our MSLs through all of our interactions that there is a massive need to have LUMRYZ available for the IH population.

我只想強調你提到的，理查德，那就是睡眠慣性。這就是每晚兩次配方的原因，他們允許每晚一次劑量高達 6 克，因為患者根本無法醒來服用第二劑，但重要的是要注意，您只能達到 6 克，這對於許多患者來說是亞治療的。因此，我們通過所有互動中的 MSL 肯定了解到，IH 人群非常需要 LUMRYZ。

Our next question comes from Matt Kaplan with Ladenburg Thalmann.

我們的下一個問題來自馬特·卡普蘭和拉登堡·塔爾曼。

Just a quick follow-up on the prior question on IH opportunity. Can you talk a little bit about the time line that you envision for lives in this -- to develop it in this indication?

只是對之前有關 IH 機會的問題的快速跟進。您能談談您對這一適應症的生活設想的時間表嗎？

Yes. I think, Matt, it's a little early right now to be precise on that. There's a number of steps we have to go through from clinical supply quota to getting our protocol finalized and approved and filing our IND and all that. We're in all the works of that now. And we'll certainly update as we cross through key milestones. It's certainly going to be an event that -- I would envision to kind of level set that we would be initiating a clinical trial in 2023. There is just a lot more work that has to be done to get us to that point. And we certainly wanted to make sure we got through our approval with LUMRYZ and narcolepsy first. So that's in full force with our team. And so we'll update as we go forward.

是的。我認為，馬特，現在明確這一點還為時過早。從臨床供應配額到協議最終確定和批准以及提交 IND 等等，我們必須經歷許多步驟。我們現在正在進行所有工作。當我們跨越關鍵里程碑時，我們肯定會進行更新。這肯定會是一個事件——我預計我們將在 2023 年啟動一項臨床試驗。要達到這一目標，我們還有很多工作要做。我們當然想確保我們首先獲得 LUMRYZ 和嗜睡症的批准。所以我們的團隊全力以赴。因此，我們將不斷更新。

Great, great. And then a question maybe for Richard. In terms of the mix of patients, understanding that what you're seeing mostly now or the majority are the switches. How do you see that evolving over time? Are the switches kind of, let's call them, the low-hanging group? Or are the patients who were previously on oxybate therapy and coming back to therapy? Are those -- you see a shift to those being the majority of patients over time?

很棒很棒。然後可能會問理查德一個問題。就患者的組合而言，了解您現在看到的大部分或大多數都是轉變。您如何看待這種情況隨著時間的推移而演變？這些開關是不是（我們可以稱其為“低端組”）？或者是之前接受過羥丁酸治療並重新接受治療的患者？隨著時間的推移，您是否看到這些患者成為大多數患者的轉變？

Yes. Matt, great question. And if we just think about our patient segments, there are more patients who have been on an oxybate than the other segments right now. So yes, right now, just from the sheer number of those patients who sort of go through, there's probably more of those patients currently on therapy. I think over time, we will start to see a little bit more of a balance across the 3 different segments there. So I think early on, we're sort of seeing a lot of the usage being consistent with the market research that we've done. And what that showed us is, over time, we should also be able to grow sort of the new patient segment as well beyond the 3,000 patients who currently go on annually for first-generation oxybate.

是的。馬特，好問題。如果我們只考慮我們的患者群體，現在接受羥丁治療的患者比其他群體要多。所以，是的，現在，僅從經歷過的患者的絕對數量來看，可能有更多的患者正在接受治療。我認為隨著時間的推移，我們將開始看到這三個不同部分之間的平衡。因此，我認為在早期，我們看到很多使用情況與我們所做的市場研究一致。這向我們表明，隨著時間的推移，我們還應該能夠擴大新的患者群體，遠遠超出目前每年接受第一代羥丁酯治療的 3,000 名患者。

Okay. And then last question in terms of on the theme of anecdotes in the field, what are you hearing in terms of counter detailing from [Jazz] in the field on you guys?

好的。最後一個問題是關於場內軼事的主題，你們從場上的[爵士樂]那裡聽到了哪些關於你們的反細節？

Well, I think those are always better questions to ask them. But I think in general, they've been very consistent. I think the message is mostly focused on sodium and clearly, as a new company, just the challenges in getting a new product sort of reimbursed. But we are so well prepared for that. We've been clear and focused on that from day one. So Matt, what I can sort of say is nothing unexpected. And our team is in a great position to handle any objections that come to them clinically or from the competition as well. So just happy to be out there and having our teams in front of sleep specialists now.

嗯，我認為向他們提出這些問題總是更好的。但我認為總的來說，他們非常一致。我認為這個信息主要集中在鈉上，顯然，作為一家新公司，只是獲得新產品補償的挑戰。但我們為此做好了充分的準備。從第一天起，我們就明確並專注於這一點。所以馬特，我可以說的是沒什麼意外的。我們的團隊能夠很好地處理臨床或比賽中提出的任何異議。因此，很高興現在能夠讓我們的團隊站在睡眠專家的面前。

And maybe just one more follow-up. I guess given the significant amount of awareness of LUMRYZ prior to the launch, do you think the rate of patients enrolling into the RYZUP system will -- I guess, was there a warehousing of patients waiting for the approval and kind of eager to get in the line there. Or do you think that pace of enrollment should continue or accelerating?

也許只是再一次後續行動。我想，考慮到 LUMRYZ 在推出之前就有大量的認知度，您認為註冊到 RYZUP 系統的患者的比例是否會——我想，是否有大量患者在等待批准，並且有點渴望進入那裡的線。或者您認為招生步伐應該繼續還是加快？

Yes. I think, Matt -- I think as we shared, I think some of our insights from being in the field is that there are certainly examples of an office who has a number of patients who they are processing and prosecuting, I don't know if I'd call them warehouse, so to speak. But I think our view is that what we've heard in the field, at least from treaters, is that they will see patients in their ordinary course, which is why it's important for us to execute on our direct to patient campaigns and to really deploy our strategies and tactics to activate patients to advocate for their therapy and go seeking out LUMRYZ as well. So those are things that we're doing, of course, that will have impact over time.

是的。我認為，馬特 - 我認為正如我們所分享的，我認為我們在該領域的一些見解是，肯定有這樣的例子：一個辦公室有許多正在處理和起訴的患者，我不知道可以這麼說，如果我稱它們為倉庫的話。但我認為我們的觀點是，我們在該領域聽到的，至少是從治療人員那裡聽到的，是他們會在正常情況下看到患者，這就是為什麼對我們來說，執行直接面向患者的活動並真正做到這一點很重要。部署我們的策略和策略來激勵患者倡導他們的治療並尋求 LUMRYZ。這些是我們正在做的事情，當然，隨著時間的推移，它們會產生影響。

But I think our view is that -- and we've seen this early in the launch, like you would expect, we've seen a cumulative increase kind of as time going on in terms of enrollments and dispensers and things like that. So our view is that, that should continue. And listen, if somebody has a large bolus that are ready to come into our system and into RYZUP, we will deploy our resources to support them. And we're prepared and have the capabilities to handle that. But I think our assumptions are that things will happen in the ordinary course.

但我認為我們的觀點是——我們在發布初期就看到了這一點，正如您所期望的那樣，隨著時間的推移，我們看到在註冊人數和分配器等方面出現了累積增長。所以我們的觀點是，這種情況應該繼續下去。聽著，如果有人準備好進入我們的系統和 RYZUP 的大量丸劑，我們將部署我們的資源來支持他們。我們已經做好準備並且有能力處理這個問題。但我認為我們的假設是事情會正常發生。

Our next question comes from Chase Knickerbocker with Craig-Hallum.

我們的下一個問題來自蔡斯·尼克博克和克雷格·哈勒姆。

Just another one on RYZUP for me, maybe hit a different vein. Talk us through the patient mix you have converted onto the drug at this point. I understand it's a fair mix of switch naive previous discontinuation in the funnel, but maybe talk us through the mix you've pulled out of the funnel at this point? Is it a much easier process, I would imagine from the medical necessity and PA process for switch patients? And then -- but is it slightly less success you have pulling naive patients or discontinued patients out of the channel? Or is it a fairly similar process that is being required?

對我來說，這只是 RYZUP 上的另一篇文章，也許有不同的風格。請告訴我們您此時已轉換為藥物的患者組合。我知道這是漏斗中先前停止的開關天真混合的公平組合，但也許可以告訴我們您此時從漏斗中拉出的組合？從轉換患者的醫療必要性和 PA 過程中我可以想像，這是一個更容易的過程嗎？然後，您將未接受治療的患者或已停藥的患者從渠道中拉出來的成功率是否會稍低一些？或者是否需要一個相當相似的過程？

Yes. I think the short answer to that is, Richard, feel free to weigh in, but I think it's reasonably representative of how they've come into the funnel. And some of that is time dependent, right? So if there's more -- when they come in and how long it takes them is individual from that standpoint, we've had patients come in early who maybe come from all 3 of those groups that have prosecuted quickly. But I think generally, given how it's been distributed coming in at the top of the funnel, I think directionally, it represents that coming out of the funnel. So Richard, feel free to weigh anymore.

是的。我認為對此問題的簡短回答是，理查德，請隨意發表意見，但我認為這合理地代表了他們如何進入漏斗。其中一些是依賴於時間的，對吧？因此，如果有更多的患者——從這個角度來看，他們什麼時候來以及需要多長時間是因人而異的，我們已經有患者提前來了，他們可能來自所有三個迅速起訴的群體。但我認為一般來說，考慮到它是如何分佈在漏斗頂部的，我認為從方向上來說，它代表了從漏斗中出來的情況。所以理查德，請放心再權衡一下。

Yes. Spot on.

是的。發現。

I mean maybe talk just for the difference in medical record requirements in the process between the 3. And they're kind of a -- if they're kind of a similar pull-through through the bottom. Is it fair to think that there are not -- one in particular is a lot more cumbersome than the rest?

我的意思是，也許只是為了討論這 3 個過程中醫療記錄要求的差異。如果它們是一種類似的從底部拉通的方式的話。公平地說，沒有一個比其他的更麻煩嗎？

Richard. Feel free to add.

理查德.歡迎補充。

Yes, it's hard to get into that level of detail because here's what happens in medical necessity. You may actually deal with one insurer, but you may actually deal with many different case reviewers. So it's a little bit of who do you get on what day of the week you get. So I think overall, we've just been very impressed that we have been able to get as many through as we have already and I think that really talks to both payers and actually clinicians being very clear about the clinical value proposition that LUMRYZ has. So the fact that this (inaudible) that fact that this means, the fact that this is fundamental to how narcolepsy should be managed. So to us, that's really been -- maybe the best upside is the fact that it appears to us that both the clinicians and the people reviewing these cases understand our clinical value proposition.

是的，很難詳細說明這一點，因為這就是醫療必需品中發生的情況。您實際上可能與一家保險公司打交道，但實際上您可能與許多不同的案例審核員打交道。因此，這有點取決於您在一周中的哪一天會見誰。所以我認為總的來說，我們對我們已經能夠獲得盡可能多的支持感到非常印象深刻，我認為這確實與付款人和臨床醫生都非常清楚 LUMRYZ 的臨床價值主張有關。因此，這個（聽不清）這個事實意味著，這個事實是如何管理髮作性睡病的基礎。所以對我們來說，這確實是——也許最好的好處是，在我們看來，臨床醫生和審查這些病例的人都理解我們的臨床價值主張。

Yes. I think the other way to think about it, Chase, is that if there's not a formal coverage policy decision, then we're going through medical necessity and it's going to go through those steps. Whether it's a de novo naive or a previous or a switch. So in many ways, it kind of operates the same way. Until there is this decision that the prior authorization criteria is set, the coverage policies in place, then it operates differently from that standpoint.

是的。我認為換個角度思考這個問題，蔡斯，如果沒有正式的承保政策決定，那麼我們將經歷醫療必要性，並且將經歷這些步驟。無論是從頭開始還是以前的或轉換的。所以在很多方面，它的運作方式都是一樣的。在決定制定事先授權標準、制定覆蓋政策之前，其運作方式與該觀點不同。

Okay. That makes sense. Yes. That's helpful color. And maybe just one on another kind of vein on color from the field. Maybe talk about sort of additional boon you've received from the clinically superior opinion from the FDA that's implied in the orphan designation, maybe feedback from the reps and how they've been effective at kind of outlaying that message and the receptivity of physicians?

好的。這就說得通了。是的。這是有用的顏色。也許只是在現場顏色上的另一種紋理上的一個。也許可以談談您從孤兒藥指定中隱含的 FDA 的臨床優越意見中獲得的額外好處，也許是來自代表的反饋，以及他們如何有效地傳播該信息和醫生的接受能力？

Richard...

理查德...

Yes. No, it's a great question, Chase. It's a very candid. It's a little bit overwhelming for some of our customers to hear that because they're not used to hearing that. And what we've really had to do is break down why we receive not only orphan drug exclusivity, to make through the major contribution to patient care. But in essence, almost to get into the steps of why we were deemed to be clinically superior, the fact that it's important not to disrupt nocturnal sleep, you're trying to avoid sleep fragmentation and with LUMRYZ, you can avoid that. So I think once you explain the steps, it becomes a lot more digestible because this [payment] on its own is almost -- in some ways almost too [powerful], right? So we really had to make sure we can explain the why behind it as opposed to just the statement itself. And I think once the why is explained, there's a lot more headlining that goes on than just giving the statement on its own. So it's a great message for us clearly, and we're just learning how to make sure it is better digested from our customers as well.

是的。不，這是一個很好的問題，蔡斯。這是非常坦誠的。對於我們的一些客戶來說，聽到這個消息有點不知所措，因為他們不習慣聽到這個消息。我們真正要做的就是解釋為什麼我們不僅獲得孤兒藥獨占權，還要為患者護理做出重大貢獻。但本質上，幾乎要了解為什麼我們被認為具有臨床優勢，事實上，重要的是不要擾亂夜間睡眠，您要努力避免睡眠碎片化，而使用 LUMRYZ，您可以避免這種情況。所以我認為一旦你解釋了這些步驟，它就會變得更容易理解，因為這種[付款]本身幾乎——在某些方面幾乎太[強大]，對吧？因此，我們確實必須確保我們能夠解釋其背後的原因，而不僅僅是聲明本身。我認為，一旦解釋了原因，就會有更多的標題，而不僅僅是單獨發表聲明。因此，這對我們來說顯然是一個很好的信息，我們正在學習如何確保我們的客戶也能更好地消化它。

Our next question comes from Myriam Belghiti with LifeSci Capital.

我們的下一個問題來自 LifeSci Capital 的 Myriam Belghiti。

Just one quick question for me. What color can you provide on the 1-month discontinuation rate in these early adopters of LUMRYZ and thoughts on how this compares to Xyrem or Xywav?

只是問我一個簡單的問題。對於這些 LUMRYZ 早期採用者的 1 個月停藥率，您能提供什麼顏色，以及與 Xyrem 或 Xywav 相比如何的想法？

Yes, Richard or Jeff -- maybe Richard, do you have any commentary on that first?

是的，理查德或傑夫——也許理查德，你對此有什麼評論嗎？

Myriam, it's really early, right? So we're just beginning to get patients on. So it's -- what's difficult when you look early on is sort of at what point in time do you consider someone discontinued. And generally, most of our rules, we sort of have step-up rules once a month has gone by without a refill or 3 months has gone by or 6 months. But you also have to recall that not every patient does get things in a standard order. So it's really too early for us to comment on this. And I think we're going to have to sort of get through probably a couple of quarters before we'll really understand a lot more of what that looks like.

米莉亞姆，現在還很早吧？所以我們才剛剛開始讓病人接受治療。所以，當你早期觀察時，困難的是你認為某人在什麼時間點停產。一般來說，我們的大多數規則，我們都會有升級規則，一旦一個月過去了而沒有補充，或者 3 個月過去了或 6 個月過去了。但您還必須記住，並非每個患者都按照標準順序拿到東西。所以我們現在對此發表評論還為時過早。我認為我們可能需要花費幾個季度的時間才能真正了解更多情況。

And I'm not showing any further questions at this time. I'd like to turn the call back over to Greg Divis for any closing remarks.

目前我不會提出任何進一步的問題。我想將電話轉回給格雷格·迪維斯，讓其作結束語。

Well, thank you, everyone, and thank you for your time and for joining us today on our second quarter call. Have a great rest of the day. We look forward to providing updates as we go forward. Thanks.

好的，謝謝大家，感謝您抽出時間參加我們今天的第二季度電話會議。祝你這一天好好休息。我們期待著在前進的過程中提供更新。謝謝。

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

女士們、先生們，今天的演講到此結束。您現在可以斷開連接，並度過美好的一天。