Avadel Pharmaceuticals PLC (AVDL) 2023 Q3 法說會逐字稿

Greetings, and welcome to the Avadel Pharmaceuticals Third Quarter 2023 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Avadel Pharmaceuticals 2023 年第三季財報電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. You may begin.

現在我很高興向史特恩投資者關係部介紹奧斯汀·默塔。你可以開始了。

Good morning, and thank you for joining us on our conference call to discuss Avadel's Third Quarter 2023 Earnings.

早安，感謝您參加我們的電話會議，討論 Avadel 的 2023 年第三季財報。

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. 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 and uncertainties are described 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 subsequent SEC filings. Except as required by law, Aveda undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise.

提醒一下，在我們開始之前，以下介紹包括構成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。前瞻性陳述受到風險和不確定性的影響，可能導致實際結果與實際結果不同實質上來自於此類前瞻性陳述中所設想的內容。這些風險和不確定性在Avadel 根據《交易法》提交的公開文件中進行了描述，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）以及隨後向SEC 提交的文件中。除法律要求外，Aveda 不承擔更新或修改本簡報中包含的任何前瞻性聲明以反映新資訊、未來事件或其他情況的義務。

On the call today are Greg Divis, Chief Executive Officer; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer. Dr. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs, will join us for Q&A.

今天參加電話會議的是執行長 Greg Divis；理查金，首席商務官；和財務長湯姆·麥克休。醫療和臨床事務高級副總裁 Jennifer Goodman 博士將與我們一起進行問答。

At this time, I'll turn the call over to Greg.

這時候，我會把電話轉給格雷格。

Thank you, Austin. Good morning, everyone, and thank you for joining us to review Avadel's third quarter 2023 results. We're excited to share the progress we have made with the launch of LUMRYZ. Following my opening remarks, Richard will provide an update on our launch progress. Tom will provide a review of our Q3 financial results, and we will conclude with a question-and-answer session.

謝謝你，奧斯汀。大家早安，感謝您與我們一起回顧 Avadel 的 2023 年第三季業績。我們很高興與大家分享 LUMRYZ 的推出所取得的進展。在我的開場白之後，理查德將提供有關我們發布進展的最新資訊。湯姆將回顧我們第三季的財務業績，最後我們將進行問答環節。

The third quarter was transformational for Avadel as we fully transition to a commercial-stage company and are very pleased with the robust early demand generated and important emerging launch trends we are seeing. There is a tremendous opportunity for LUMRYZ and Avadel that lies ahead as we execute our launch. We believe the foundation we are building during these early months positions us incredibly well for continued success building on the momentum built during this first full quarter of launch.

第三季對 Avadel 來說是一次轉型，我們完全轉型為商業階段的公司，並對產生的強勁早期需求和我們看到的重要的新興發布趨勢感到非常滿意。當我們執行發佈時，LUMRYZ 和 Avadel 面臨著巨大的機會。我們相信，我們在最初幾個月建立的基礎使我們能夠在發布第一個完整季度所建立的勢頭的基礎上繼續取得成功。

During Q3, this momentum resulted in growth across all key launch metrics, representing strong demand across all 3 patient segments of the eligible narcolepsy patient population and generated $7 million in LUMRYZ net revenue. There's no better evidence of this than the early launch KPIs we announced this morning: Greater than 1,000 patients enrolled in RYZUP, and more than 400 patients who initiated therapy during the quarter, the majority of which are fully reimbursed. Expanded LUMRYZ payer coverage with key health plans, representing approximately 60% of all commercial lives, and this progress on the payer front continues to create even greater access for the 600 patients enrolled in our RYZUP patient services program and in process of obtaining coverage and getting on LUMRYZ as of September 30.

在第三季度，這一勢頭導致所有關鍵發布指標均實現增長，代表了符合條件的發作性睡病患者群體的所有3 個患者群體的強勁需求，並為LUMRYZ 帶來了700 萬美元的淨收入。沒有比我們今天早上宣布的早期啟動 KPI 更好的證據了：超過 1,000 名患者註冊了 RYZUP，超過 400 名患者在本季度開始了治療，其中大部分都得到了全額報銷。透過關鍵健康計劃擴大了LUMRYZ 付款人覆蓋範圍，約佔所有商業生活的60%，付款人方面的這一進展繼續為參加我們的RYZUP 患者服務計劃並正在獲得承保和獲得服務的600 名患者創造更多的機會截至 9 月 30 日在 LUMRYZ 上。

Additionally, there are nearly 1,400 health care providers who have now completed the LUMRYZ REM certification process, including providers who have never previously prescribed an oxybate.

此外，目前已有近 1,400 家醫療保健提供者完成了 LUMRYZ REM 認證流程，其中包括以前從未開過羥丁藥物處方的提供者。

We're very encouraged by these early KPIs and believe there are indicators of the strong interest and profit engagement we have had with all stakeholders as we've advanced the launch of LUMRYZ. Furthermore, to support the robust clinical data at LUMRYZ, our team recently attended World Sleep in Rio de Janeiro, Brazil, where we shared 15 poster presentations and 2 oral presentations detailing new and encore data, further demonstrating the clinical profile and clear benefit of LUMRYZ for potential eligible patients.

我們對這些早期 KPI 感到非常鼓舞，並相信在我們推進 LUMRYZ 的推出時，有跡象表明我們與所有利益相關者都表現出了強烈的興趣和利潤參與。此外，為了支持LUMRYZ 的可靠臨床數據，我們的團隊最近參加了在巴西里約熱內盧舉行的世界睡眠大會，我們在會上分享了15 場海報展示和2 場口頭演講，詳細介紹了新數據和再次數據，進一步展示了LUMRYZ 的臨床概況和明顯優勢對於潛在的合格患者。

And looking forward to the future, our team is also advancing our life cycle management opportunities as we believe this has the potential to expand the patient population who could benefit from LUMRYZ and provide long-term value to the company and our stakeholders. We are pleased to announce that yesterday, we submitted a supplemental new drug application to the FDA for LUMRYZ in the pediatric narcolepsy population for the treatment of cataplexy or EDS, and currently expect an approval decision in the second half of 2024.

展望未來，我們的團隊也正在推進我們的生命週期管理機會，因為我們相信這有可能擴大可以從 LUMRYZ 中受益的患者群體，並為公司和我們的利害關係人提供長期價值。我們很高興地宣布，昨天，我們向 FDA 提交了 LUMRYZ 在兒科發作性睡病人群中用於治療猝倒或 EDS 的補充新藥申請，目前預計將於 2024 年下半年做出批准決定。

Comprising approximately 4% to 5% of the current total oxybated treated narcolepsy population expanding availability into the pediatric population, not only increases the total addressable market for LUMRYZ, but also has the potential to greatly alleviate the burden on families and caregivers who support children living with narcolepsy. We believe these families and caregivers will welcome a once-at-bedtime oxybate treatment option as the twice-nightly dosing regimen of first-generation oxybate inevitably requires potentially multiple people in the household to chronically wake up night after night to administer the second dose for their children.

約佔目前接受羥丁化治療的發作性睡病患者總數的4% 至5%，將其可用性擴大到兒科人群，不僅增加了LUMRYZ 的潛在市場總量，而且有可能大大減輕支持兒童生活的家庭和護理人員的負擔患有發作性睡病。我們相信，這些家庭和照護人員會歡迎睡前一次的羥丁治療方案，因為第一代羥丁的每晚兩次給藥方案不可避免地需要家庭中的多個人長期夜復一夜地醒來，以給予第二劑藥物。他們的孩子。

Additionally, we're making progress with our clinical planning to initiate a multicenter randomized controlled trial for idiopathic hypersomnia, or IH. And we believe, based upon our interactions with key opinion leaders, that the value proposition once-at-bedtime LUMRYZ could be very compelling for those suffering from the deep sleep inertia associated with IH.

此外，我們的臨床計劃正在取得進展，啟動了一項針對特發性睡眠過多（IH）的多中心隨機對照試驗。我們相信，根據我們與關鍵意見領袖的互動，睡前一次 LUMRYZ 的價值主張對於那些患有與 IH 相關的深度睡眠慣性的人來說可能非常有吸引力。

And last thing on the life cycle management front, we are continuing our preclinical development of our potential no or low sodium once-in-time oxybate formulation for the small subset of sodium-sensitive oxybate-eligible patients. As always, we intend to provide updates on these programs as appropriate.

在生命週期管理方面的最後一件事是，我們正在繼續針對一小部分對鈉敏感且符合羥丁酸治療資格的患者，進行潛在的無鈉或低鈉一次性羥丁酸製劑的臨床前開發。一如既往，我們打算酌情提供這些計劃的更新。

With a strong balance sheet to support ongoing operations and the significant progress achieved in the initial months of the launch, we remain hyper-focused on the LUMRYZ launch and expanding our reach and our impact. We are committed to and remain relentless in delivering on the promise of LUMRYZ for all stakeholders. And with this positive momentum coming out of Q3, we believe we are on track to command a meaningful share of the multibillion-dollar oxybate market and maintain our view that New right is a greater than $1 billion annual revenue opportunity.

憑藉強大的資產負債表來支持持續營運以及在發布的最初幾個月中取得的重大進展，我們仍然高度關注 LUMRYZ 的發布並擴大我們的覆蓋範圍和影響力。我們致力於並堅持不懈地兌現 LUMRYZ 對所有利害關係人的承諾。隨著第三季出現的這種積極勢頭，我們相信我們有望在數十億美元的羥丁酸鹽市場中佔據有意義的份額，並維持我們的觀點，即New right 是一個超過10 億美元的年收入機會。

With that, I'll turn the call over to Richard for details on our recent commercial progress. Richard.

這樣，我會將電話轉給理查德，以了解我們最近的商業進展的詳細資訊。理查德.

Thanks, Greg, and good morning, everyone. It's so great to be on this call today to discuss our first quarter of launch. Let me start by saying it's a real privilege to bring LUMRYZ to the Northwest community. Since August, our full commercial team has been in the field seeing specialists across the country, and the overall feedback has been extremely positive.

謝謝格雷格，大家早安。很高興今天參加這次電話會議討論我們第一季的發布。首先我要說的是，我非常榮幸能將 LUMRYZ 引入西北社區。自八月以來，我們的整個商業團隊一直在全國範圍內拜訪專家，整體反饋非常積極。

We've heard for a long time about the impact about a once-at-bedtime oxybate that it could have for people in reps. And now we are out to see that impact iris happening each and every day. We consistently hear from the narcolepsy community that LUMRYZ has the potential to take people at narcolepsy beyond their expectations of other available treatment options.

我們很早就聽到睡前一次氧丁療法可能對代表者產生的影響。現在我們每天都能看到這種影響正在發生。我們不斷從嗜睡症社區得知，LUMRYZ 有潛力讓嗜睡症患者超越他們對其他可用治療方案的期望。

I'd like to start with one example of the many impressions we've had with sleep specialist, and the impact on their life it is having. During a recent field drive, we met with a sleep specialist who enrolled his first person a RYZUP in August. The patient started on LUMRYZ a few weeks later. Now this patient was previously taking the first-generation mix-out product and switched to 7.5 grams of once-at-bedtime LUMRYZ. The patient has remained on 7.5 grams of limit per night is consistently sleeping through the night, and she said, "We more refresh the morning ready to start for day."

我想先舉一個例子來說明我們對睡眠專家的許多印象，以及它對他們生活的影響。在最近的一次實地考察中，我們遇到了一位睡眠專家，他於 8 月為第一個人註冊了 RYZUP。幾週後，患者開始使用 LUMRYZ。現在，該患者之前服用第一代混合產品，並改用 7.5 克睡前一次的 LUMRYZ。患者一直保持每晚 7.5 克的攝入量，並始終保持整夜睡眠，她說：“我們早上會更加精神煥發，為新的一天做好準備。”

LUMRYZ has been an absolute game changer for this patient. While this is just one example of the journey to gain initial hands on clinical experience, the sleep specialists had great initial success with LUMRYZ and subsequently committed 4 or more patient enrollments into RYZUP.

對這位患者來說，LUMRYZ 絕對是遊戲規則的改變者。雖然這只是獲得初步臨床經驗過程中的一個例子，但睡眠專家在 LUMRYZ 上取得了巨大的初步成功，隨後將 4 名或更多患者納入 RYZUP。

To echo Greg, we are super excited about this strong start we've had and believe our progress reflects the clinical benefit of LUMRYZ, our strategic preparation and the hard work and dedication of our team. We're pleased to share today that through our first full quarter launch, there are greater than 1,000 patient enrollments into RYZUP, our patient support center. From our RYZUP data, enrollment in patients on therapy are coming from all 3 of our target patient segments. Switch patients from first-generation oxybate. Patients who previously tried to discontinuation discontinued first generation oxybate and oxybate-naive patients. Thus far, we are seeing an early trend that the majority are being sourced from first-generation oxybate with slightly more coming from the twice-nightly (inaudible) product compared to the twice-nightly (inaudible) oxybate products.

與 Greg 一樣，我們對這個強勁的開端感到非常興奮，並相信我們的進展反映了 LUMRYZ 的臨床效益、我們的策略準備以及我們團隊的辛勤工作和奉獻精神。今天我們很高興與大家分享，透過我們第一個完整季度的推出，已有超過 1,000 名患者登記加入我們的患者支援中心 RYZUP。根據我們的 RYZUP 數據，接受治療的患者入組來自我們的所有 3 個目標患者群體。將患者從第一代羥丁酸中切換。先前嘗試停藥的患者停止使用第一代羥丁酯和未接受過羥丁酯的患者。到目前為止，我們看到了一個早期趨勢，即大多數產品來自第一代oxybate，與每晚兩次（聽不清楚）的oxybate 產品相比，每晚兩次（聽不清）的產品來源略多。

Through the end of September, there were nearly 1,400 HCPs who are REM-certified. As a reminder, our core target HCPs includes the 1,600 high-line oxybate prescribers who make up 80% of the total market prescription volume. The greatest penetration of REM-certified HCPs has come from these high-volume oxybate prescribers, and they account for about 3/4 of all rise enrollments thus far. Although the trends from RYZUP are early, with patients coming from previously distant first-generation oxybate patients also oxalate patients and prescribers who have previously never prescribed an oxybate. Our early data set for assume LUMRYZ growing the market beyond the limitations of our first-generation twice-nightly oxybates were used.

截至 9 月底，已有近 1,400 名 HCP 獲得 REM 認證。提醒一下，我們的核心目標 HCP 包括 1,600 名高線羥丁處方者，他們佔市場處方總量的 80%。 REM 認證的 HCP 的最大滲透率來自於這些大量的羥丁藥物處方者，迄今為止，他們約佔所有新增註冊人數的 3/4。儘管 RYZUP 的趨勢很早，但來自以前遙遠的第一代羥丁酸鹽患者的患者也包括草酸鹽患者和以前從未開過羥丁酸鹽處方的處方者。我們使用的早期數據集假設 LUMRYZ 的市場成長超出了我們第一代每晚兩次羥丁藥物的限制。

Supported by the increasing number of RYZUP enrollments. Today, we also announced in the third quarter, we had greater than 400 patients who initiated treatment on LUMRYZ. We saw the network pacing rights to grow within the quarter as more payer coverage begins to come online. The majority of patients initiated with LUMRYZ are commercially reimbursed.

受到 RYZUP 註冊人數不斷增加的支持。今天，我們也宣布，在第三季度，我們有超過 400 名患者開始接受 LUMRYZ 治療。隨著更多的付款人覆蓋範圍開始上線，我們看到網路調速權在本季度有所增長。大多數接受 LUMRYZ 治療的患者均可獲得商業報銷。

Additionally, and although early in launch, we're seeing discontinuation trends that are lower than the 25% discontinuation rate at 1 month from first generation oxybates.

此外，儘管在推出初期，我們看到停藥趨勢低於第一代羥丁酸鹽 1 個月時 25% 的停藥率。

When we think about all the time it takes to the fill enrollment and debt arise, there are generally 2 main segments that are emerging. First, those who have coverage a prior authorization criteria. These patients can be processed and ship products on average in about a month. As our coverage of payers expand, this segment of patients will continue to grow.

當我們考慮到填補入學所需的所有時間和債務產生時，通常有兩個主要部分正在出現。首先，那些具有事先授權標準的承保人。這些患者平均可以在一個月左右的時間內處理並運送產品。隨著我們支付者覆蓋範圍的擴大，這部分患者將持續成長。

Now for patients going from medical necessity without a formal coverage policy decision. This generally consists of pair denials and HCP appeal, a process that could take longer. More like a couple of months on average with some occurring a bit sooner and setting even a bit longer. This segment is getting smaller as our coverage grows. However, and very importantly, despite these cases taking longer to fulfill, we also see very few people dropping out of the RYZUP process.

現在針對沒有正式承保政策決定的醫療需求的病人。這通常包括配對拒絕和 HCP 上訴，這個過程可能需要更長的時間。平均來說大約是幾個月，有些發生得更早，甚至更長。隨著我們覆蓋範圍的擴大，這個細分市場正在變得越來越小。然而，非常重要的是，儘管這些案例需要更長的時間才能完成，但我們也看到很少有人退出 RYZUP 流程。

At the end of September, approximately 600 patients were in the RYZUP of process still, going through the benefits investigation or pending a first shipment. Based on early loss trends through Q3, we currently anticipate that the majority of these patients will convert on to LUMRYZ as they complete their RYZUP process. Product fulfillment is very dynamic. And we are in a fundamentally stronger place with the use of RYZUP and services than we were just a couple of months ago.

截至 9 月底，大約 600 名患者仍在 RYZUP 流程中，正在進行福利調查或等待第一批出貨。根據第三季的早期損失趨勢，我們目前預計大多數患者在完成 RYZUP 流程後將轉而使用 LUMRYZ。產品履行是非常動態的。與幾個月前相比，透過使用 RYZUP 和服務，我們的處境從根本上變得更加強大。

More important is that sleep specialist offices are getting increased experience with the enrollment process and are beginning to spend additional patients to RYZUP.

更重要的是，睡眠專家辦公室在註冊過程中獲得了越來越多的經驗，並開始向 RYZUP 派遣更多患者。

Now that's a nice segue to transition to payers, where we continue to make strong progress in securing broad coverage for the mine. Currently, BMS coverage policies were over 100 million insured lives representing approximately 60% of the totally commercially covered lives.

現在，這是向付款人過渡的一個很好的過渡，我們在確保礦山的廣泛覆蓋方面繼續取得重大進展。目前，BMS 承保保單覆蓋人數超過 1 億，約佔商業承保總人數的 60%。

We recently added coverage with policies in place with key national insurers, like Aetna and Cigna, in addition to several regional and state plans. We also completed the zinc GPO contract where importantly, LUMRYZ will be moved to a preferred status within CVS commercial formularies effective January 1, 2024. Currently, LUMRYZ is in nonpreferred position.

除了一些地區和州計劃外，我們最近還增加了與 Aetna 和 Cigna 等主要國家保險公司製定的政策的承保範圍。我們還完成了鋅 GPO 合同，重要的是，自 2024 年 1 月 1 日起，LUMRYZ 將在 CVS 商業處方中轉為優先地位。目前，LUMRYZ 處於非優先地位。

We are very pleased with our payer progress. And importantly, feedback with sleep specialist offices has generally been very positive for the early success rate from reimbursement they've been seeing.

我們對付款人的進展感到非常滿意。重要的是，睡眠專家辦公室的回饋普遍對他們所看到的報銷的早期成功率非常積極。

These first events have set a great foundation for our launch. As we see the demand from LUMRYZ continue to grow, offices and our teams improving the efficiency for getting patients started and staying on LUMRYZ and more covered lives with payers. We could not be prouder of the collective work of our team in bringing LUMRYZ to the narcoleptic committee, along with the progress and trends we've seen to date. We look forward to providing more updates on future calls.

這些首批活動為我們的推出奠定了良好的基礎。隨著我們看到 LUMRYZ 的需求不斷增長，辦公室和我們的團隊提高了患者開始使用 LUMRYZ 並繼續使用 LUMRYZ 的效率，並提高了付款人的核保生活。我們為我們團隊將 LUMRYZ 引入嗜睡症委員會的集體工作以及我們迄今為止所看到的進展和趨勢感到無比自豪。我們期待在未來的通話中提供更多更新。

And now I will turn the call over to Tom to discuss our financials. Tom?

現在我將把電話轉給湯姆討論我們的財務狀況。湯姆？

Thank you, Richard. I'll note that full financial results are available in the press release and the 10-Q. We're pleased to report that we generated $7 million in net revenue for the third quarter ending September 30, 2023, and $8.5 million in total revenue since our launch began in June of 2023. We're continuously monitoring inventory levels in the channel. And during the course of the third quarter, we estimated that it was consistently between 3 to 4 weeks of demand, including as we exited the quarter.

謝謝你，理查。我要指出的是，完整的財務表現可在新聞稿和 10-Q 中找到。我們很高興地報告，截至2023 年9 月30 日的第三季度，我們的淨收入為700 萬美元，自2023 年6 月推出以來，總收入為850 萬美元。我們正在持續監控通路中的庫存水平。在第三季期間，我們估計需求持續在 3 到 4 週之間，包括在本季結束時。

Turning to operating expenses. We reported a total of $42 million of GAAP operating expenses during the quarter ended September 30, 2023, which includes $39.2 million of SG&A costs and $2.8 million of R&D costs. Operating expenses includes $4.6 million of noncash charges for stock-based compensation and depreciation and amortization. After adjusting for these items, cash operating expenses were $37.4 million for the quarter. And we are currently expecting cash operating expenses in the fourth quarter to be in the range of $38 million to $40 million.

轉向營運費用。截至 2023 年 9 月 30 日的季度，我們報告的 GAAP 營運費用總計為 4,200 萬美元，其中包括 3,920 萬美元的銷售管理費用和 280 萬美元的研發成本。營運費用包括 460 萬美元的非現金費用，用於基於股票的薪酬以及折舊和攤提。在這些項目進行調整後，本季現金營運支出為 3,740 萬美元。我們目前預計第四季的現金營運支出將在 3,800 萬美元至 4,000 萬美元之間。

With respect to the balance sheet, we exited Q3 in a strong position. As of September 30, 2023, we had $153.2 million of cash, cash equivalents and marketable securities, which includes $30 million received in August from the first tranche of the $75 million royalty financing commitment we secured earlier this year. A second tranche of $45 million is available if we achieved $25 million of quarterly net revenue by June 30, 2024. And as a reminder, while the $45 million could be available, we are not required to draw the second tranche.

就資產負債表而言，我們在第三季處於強勢地位。截至2023 年9 月30 日，我們擁有1.532 億美元的現金、現金等價物和有價證券，其中包括8 月份從我們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款項中收到的3000 萬美元。如果我們在 2024 年 6 月 30 日之前實現了 2500 萬美元的季度淨收入，則可以獲得第二筆 4500 萬美元。提醒一下，雖然可以提供 4500 萬美元，但我們不需要提取第二筆。

As we look ahead, we believe, based on current plans and expectations that we can achieve cash flow breakeven from operations when there are approximately 1,300 to 1,500 reimbursed patients being treated with LUMRYZ. Our expectation is taking into account a number of assumptions, including capital resources currently available to us, patient demand, net pricing of LUMRYZ and ongoing cost structure to support the launch of LUMRYZ. Actual results versus these assumptions, in addition to ongoing planning for growth initiatives, such as an IH study, could impact our expectations regarding future capital requirements.

展望未來，我們相信，根據目前的計劃和預期，當大約 1,300 至 1,500 名報銷患者接受 LUMRYZ 治療時，我們可以實現營運現金流盈虧平衡。我們的預期考慮到了許多假設，包括我們目前可用的資本資源、患者需求、LUMRYZ 的淨定價以及支持 LUMRYZ 推出的持續成本結構。實際結果與這些假設的比較，以及持續的成長計畫規劃（例如 IH 研究）可能會影響我們對未來資本需求的預期。

And on a final note, at September 30, we had approximately $21 million of convertible notes shown as debt on the balance sheet. This last remaining tranche of debt was settled in cash at the beginning of October. And effective with that paydown, the balance sheet is now completely free of convertible debt.

最後一點是，截至 9 月 30 日，我們的資產負債表上有大約 2,100 萬美元的可轉換票據作為債務。最後一批債務已於 10 月初以現金結算。支付完畢後，資產負債表現在完全沒有可轉換債務。

And I'll now turn the call back to Greg for closing remarks.

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 launch of LUMRYZ, and we are laser-focused on continuing to execute on all our priorities. Our goal since the inception of Avadel has been to provide treatments that can transform the lives of those living with narcolepsy, and we believe we've made significant progress in this area and look forward to our continued launch execution and positively impacting even more patients. We thank you for your support and look forward to providing future updates on our progress.

謝謝你，湯姆。我們相信，我們堅實的基礎支持了 LUMRYZ 的成功首次推出，並且我們將專注於繼續執行我們的所有優先事項。自 Avadel 成立以來，我們的目標一直是提供能夠改變嗜睡症患者生活的治療方法，我們相信我們在這一領域已經取得了重大進展，並期待我們繼續推出執行並為更多患者帶來積極影響。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資訊。

And with that, we will open the call for questions. Operator?

接下來，我們將開始提問。操作員？

(Operator Instructions) Our first question comes from Ami Fadia from Needham.

（操作員說明）我們的第一個問題來自 Needham 的 Ami Fadia。

Congrats on the nice update on the launch. I have 1 or 2 quick questions. Firstly, can you talk about the rate at which you're seeing enrollment in RYZUP? And maybe give us some more color on where these patients are coming from in terms of whether they're coming from or new patients? If you can give us some more color there?

祝賀發佈時的精彩更新。我有 1 或 2 個簡單問題。首先，您能談談 RYZUP 的註冊率嗎？也許可以讓我們更了解這些患者來自哪裡，無論他們是來自還是新患者？你能給我們更多的顏色嗎？

Yes. Thanks, Ami. Richard, do you want to...

是的。謝謝，阿米。理查德，你想...

Yes. Thanks, Ami. Yes, it's really been fantastic to see the interest that (inaudible) arrived. And we're super pleased that when we gave our first update about 2 months into launch, there are about 400 patients rolled into RYZUP. And then in the next 2 months, about an actual 600 pieces have come on board. So really good momentum. Maybe holistically, as we start to think about the launch, the first thing we sort of say is when we see sleep specialists, we have really yet to see one who haven't seen the clinical value proposition of their rights. And when we think about the trends going forward, we haven't really sort of seen what I would be described as bolus as many offices, but really more of a sort of an influx of patients being seen in the regular course of follow-up, which is about every 3 to 9 months.

是的。謝謝，阿米。是的，看到人們的興趣（聽不清楚）的到來真是太棒了。我們非常高興的是，當我們在發布大約 2 個月後進行第一次更新時，大約有 400 名患者加入了 RYZUP。在接下來的 2 個月裡，大約有 600 件產品已經上船。所以勢頭真的很好。也許從整體上來說，當我們開始考慮推出時，我們要說的第一件事是，當我們看到睡眠專家時，我們確實還沒有看到沒有看到其權利的臨床價值主張的人。當我們思考未來的趨勢時，我們並沒有真正看到我所說的像許多辦公室那樣的推注，但實際上更多的是在常規隨訪過程中看到的患者湧入，大約每3 到9個月一次。

So when we start to think about sort of going forward, we just continue to sort of see continued steady demand for their rights. We also know that the holidays are coming up sort of as we get into November, December, so it's just something to account for. But our focus remains very much on the launch execution and obviously, patient activation. I will also say, in the future, we do think things we've seen when coverage policy changes have occurred, they can act as catalysts as we sought for CVS earlier, that going to preferred should help us as we go to January. And also, we continue to work that we have with our MSR GPO contract as well.

因此，當我們開始考慮未來的發展時，我們只是繼續看到對他們權利的持續穩定的需求。我們也知道，隨著進入 11 月、12 月，假期即將到來，所以這只是需要考慮的因素。但我們的重點仍然是啟動執行，顯然還有患者的活化。我還要說，在未來，我們確實認為當承保政策發生變化時我們所看到的事情，它們可以充當我們早些時候尋求 CVS 的催化劑，當我們進入 1 月份時，首選應該會幫助我們。此外，我們還將繼續履行我們的 MSR GPO 合約。

Now speaking to the types of patients, we consistently sort of see sourcing from policy patient segments, which discontinued previously in naive. And thus far through the launch, we're seeing the majority coming from previously experienced -- or currently oxybated patients with more tending towards coming from the mix up in the twice-nightly oxybates as well.

現在談到患者類型時，我們始終看到從政策患者群體中採購，而這些患者之前是天真地停止的。到目前為止，在發布過程中，我們看到大多數來自以前經歷過或目前接受過氧丁化治療的患者，其中更多的人也傾向於每晚兩次氧丁化治療的混合。

So it does their army, it's real. It's been awesome to be in the deal for all of us. There's always more that we can do, but we're super pleased with the progress we've made so far.

他們的軍隊也是如此，這是真的。對我們所有人來說，參與這筆交易真是太棒了。我們總是有更多的事情可以做，但我們對迄今為止所取得的進展感到非常滿意。

Great. And maybe just on the payer coverage front, you talked about currently having over 100 million insured lives. How should we think about the remaining? And then when -- give us some sense of the time frame into 2024 where we could see coverage expand.

偉大的。也許只是在付款人保險方面，您談到目前有超過 1 億人受保。剩下的我們該如何思考？然後，讓我們了解 2024 年的時間框架，我們可以看到覆蓋範圍擴大。

Yes, sure. We're pretty selfish. We want as many covered lives as we possibly can get because that's really the gateway to getting patients onto therapy. So the general process is you get -- you get the GPO contracts signed, then we have to pull through with major PBMs underneath that. So we've been doing that under both the intent or the ESA (inaudible) contract, now the zinc CBS contract as well. The third one is the MSR sort of Optum United lives. It always takes a long goods. But we've made very good progress there. And we fully anticipate growing our covered lives as we go forward here as well.

是的，當然。我們真是太自私了。我們希望盡可能獲得承保，因為這確實是讓患者接受治療的門戶。因此，一般流程是簽署 GPO 合同，然後我們必須在其之下完成主要的 PBM。因此，我們一直在根據意圖或 ESA（聽不清楚）合同，現在也在鋅 CBS 合約下這樣做。第三種是Optum United 的MSR 生活。總是需要很長的貨。但我們已經在這方面取得了很好的進展。當我們在這裡前進時，我們也完全期待著擴大我們的保障生活。

So I mean, to be where we are sort of through our first full quarter launch and how this coverage has been pretty impressive. And I think what will be played out in the marketplace is the general feedback we hear from providers being maybe pleasantly surprised with the reimbursement rate that they're seeing.

所以我的意思是，透過我們的第一個完整季度的發布，我們已經達到了這樣的程度，而這種覆蓋範圍令人印象深刻。我認為市場上將出現的是我們從提供者聽到的普遍回饋，他們可能對他們所看到的報銷率感到驚訝。

So sort of like many of our metrics, we're looking sort of upward and to the right to grow our covered lives going forward.

就像我們的許多指標一樣，我們正在尋找向上和向右的方向來擴大我們未來的核保生活。

(Operator Instructions) Our next question comes from Andrew Sai with Jefferies.

（操作員說明）我們的下一個問題來自 Jefferies 的 Andrew Sai。

Just wanted to say congrats myself as well. It's really great to see the launch going very well. So first question on the conversion rate, it looks like you got 1,000 sign-ups in the quarter, 400 essentially getting treatment. So loosely speaking, it seems like a 40% conversion rate, give or take. And I think you said in the prepared remarks, the majority will convert from RYZUP. So is it fair to assume that 40% conversion rate moves up meaningfully going forward?

我也想說恭喜我自己。很高興看到發布進展順利。第一個問題是關於轉換率，看起來本季有 1,000 名註冊用戶，其中 400 名基本上得到了治療。粗略地說，無論給予或接受，轉換率似乎都是 40%。我認為您在準備好的演講中說過，大多數人將從 RYZUP 轉變。那麼，假設 40% 的轉換率在未來有意義地上升是否公平？

And then secondly, if you were to take another cut of the KPIs as of today, November 8, how would those leading indicators look? Just want to make sure these numbers are not a onetime bolus, that you're seeing even more patients signed up and treated, things are moving up and to the right.

其次，如果從今天（11 月 8 日）起再次削減 KPI，這些領先指標會是什麼樣子？只是想確保這些數字不是一次性的，你會看到更多的患者報名並接受治療，事情正在向上和向右發展。

Yes. Thanks, Andrew. Here's how I can answer those questions. First off, in terms of your 40%, it's really apples to oranges a little bit. and the 40% is certainly not the majority, and our commentary is what we've seen for patients who have been in the system for at least some period of time that our conversion rates to on therapy is certainly the majority of patients. So we would expect 40% not as the right proxy currently in terms of what we're seeing early on in the launch.

是的。謝謝，安德魯。我可以這樣回答這些問題。首先，就 40% 而言，這確實有點相似。 40% 肯定不是大多數，我們的評論是我們對已經在系統中至少一段時間的患者所看到的，我們的治療轉換率肯定是大多數患者。因此，就我們在發布初期所看到的情況而言，我們預計 40% 目前不是正確的代理商。

And obviously, that's a number we want to continue to improve on and payer coverage decisions and whatnot are really important advances. But the progress made on the payer front has certainly been beneficial to us in seeing a majority of patients converting on to therapy and the majority of those converting on to reimbursed drug.

顯然，這是我們希望繼續改進的數字，付款人承保決策等都是非常重要的進步。但付款人方面的進展無疑對我們有利，因為我們看到大多數患者轉向接受治療，並且大多數患者轉向報銷藥物。

Secondly, to your comment about whether the -- how does the early part of Q4 look. Again, I think we've seen -- we continue to see more enrollments and more people go on therapy and growth continue. So yes, I mean, I think we feel really good where we sit and the progress we're making across all fronts. And knowing that there's a whole lot more to do, but we're really pleased where we sit today.

其次，關於您對第四季度早期情況的評論。我想我們再次看到——我們繼續看到更多的入學人數和更多的人接受治療，並且增長仍在繼續。所以，是的，我的意思是，我認為我們對我們所處的位置以及我們在各個方面取得的進展感覺非常好。我們知道還有很多事情要做，但我們對今天的處境感到非常高興。

Our next question comes from Marc Goodman with Leerink Partners.

我們的下一個問題來自 Leerink Partners 的 Marc Goodman。

This is Rudy on the line for Marc. So I have a question regarding your patient dynamic here. So you mentioned that most of patients reaching from first-gen activate products. Just curious what are the feedbacks you've been hearing from these patients, especially those who switch from Ziva? What are your strategy to penetrate patients who are oxybate-naive and who previously treated and discontinue?

我是魯迪，正在接聽馬克的電話。所以我有一個關於您的患者動態的問題。所以你提到大多數患者使用第一代啟動產品。只是好奇您從這些患者（尤其是那些從 Ziva 轉用的患者）那裡聽到了哪些回饋？您對未接受過羥丁酸治療以及先前接受過治療但停藥的患者的滲透策略是什麼？

Yes. Thanks for the question. Yes, as we talked about in our prepared remarks, when we think about the source of patients thus far, the majority are from those first-generation oxybate. The patient narratives that I gave early on was one that represents many of the conversations we've had about patient switching from sideways.

是的。謝謝你的提問。是的，正如我們在準備好的演講中談到的，當我們考慮迄今為止的患者來源時，大多數來自第一代羥丁酸。我早期給出的患者敘述代表了我們關於患者從側面轉換的許多對話。

And one of the insights we had from that, even a couple of years ago, where a lot of the patients who -- we've gone on to the mid-afternoon early on. They tend to be early adopters of product. They tend to be diagnosed for a shorter period of time, switching, looking for more new for their treatment. So we haven't seen a surprise, the fact that we've had Mixall patients coming on to the rate that we have thus far.

我們從中得到的見解之一，甚至在幾年前，很多病人——我們很早就到了下午三點左右。他們往往是產品的早期採用者。他們往往會在較短的時間內得到診斷，然後進行轉換，尋找更多新的治療方法。因此，我們並沒有看到 Mixall 患者達到我們迄今為止的速度這一事實，這一事實令人驚訝。

And then as we think about going forward, the really nice thing about our execution is when we think about our narcolepsy treaters and prescribers, it's a very concentrated physician base, 4,500 make up the entire universe, 1,600 80% of the volume. So those naive and discontinued patients generally are in the same offices the people that we're seeing where these switch opportunities are as well.

然後，當我們思考未來時，我們的執行中真正好的事情是，當我們想到我們的發作性睡病治療師和處方者時，這是一個非常集中的醫生基礎，4,500 名醫生組成了整個宇宙，1,600 名醫生佔總量的80%。因此，那些天真的和停藥的患者通常與我們看到的這些轉換機會所在的人在同一個辦公室。

So I think what we've seen is it sort of depends where the patient the physician is on their journey, but we've also sort of seen a nice uptick in both the previously discontinued and the patients as well. So we're just very pleased to sort of see the pull-through of our strategy and growth coming from all 3 patient segments.

因此，我認為我們所看到的是，這在某種程度上取決於患者和醫生在治療過程中所處的位置，但我們也看到之前停藥的患者和患者的情況都有不錯的上升。因此，我們非常高興看到我們的策略和成長來自所有 3 個患者細分市場。

Yes. I think, Rudy, to some extent, it's also a bit of a math equation as well because there are just meaningfully more patients in offices who are on existing therapies today than those who are truly newly diagnosed, that the average annual newly diagnosed rate is around 3,000 patients per year, and 80% of those are in our primary targets. The average target has 1 or 1.5 patients per year.

是的。我認為，魯迪，在某種程度上，這也有點像一個數學方程式，因為今天在辦公室接受現有治療的患者比真正新診斷的患者要多得多，平均每年新診斷率為每年約3,000名患者，其中80% 屬於我們的主要目標。平均目標每年有 1 或 1.5 名患者。

So again, those will continue to come in the ordinary course. As they come in, and we certainly are messaging around the importance of LUMRYZ for new starts as well. But I think also you're seeing just a manifestation of, early in the launch, kind of the math equation of more intervention opportunities for those who are on therapy than those who are coming in as potential new starts.

同樣，這些將繼續按常規進行。隨著它們的出現，我們當然也在傳達 LUMRYZ 對於新起點的重要性。但我認為你也看到了一種數學方程式的表現，即在啟動初期，正在接受治療的人比那些潛在的新開始的人有更多的干預機會。

Got it. That's very helpful. Can you also talk about the gross to net? Any color would be helpful.

知道了。這非常有幫助。您還能談談毛淨值嗎？任何顏色都會有幫助。

On the gross to net? .

毛淨額？ 。

Yes.

是的。

Yes. So listen, at this stage of the launch, we're early, and we haven't quite reached a steady state on gross net. There's more payer contracting to be done. -- payer mix is certainly going to affect the gross to nets. But as we're looking forward, we think continues to be a reasonable target to assume really on a net revenue per patient basis, is about $120,000 per year.

是的。所以聽著，在發布的這個階段，我們還處於早期階段，而且我們的總淨值還沒有達到穩定狀態。還有更多的付款人合約需要完成。 ——付款人組合肯定會影響網路總收入。但就我們的展望而言，我們認為，假設每位患者的淨收入每年約為 12 萬美元，這仍然是一個合理的目標。

We're not there today, just to be clear. We have patients that are starting therapy going through a titration schedule on lower doses. But ultimately, as we move forward to a steady state we think that $120,000 per year per patient is a reasonable assumption.

我們今天不在那裡，只是為了澄清。我們有一些正在開始治療的患者正在經歷較低劑量的滴定計劃。但最終，當我們邁向穩定狀態時，我們認為每位患者每年 12 萬美元是一個合理的假設。

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。

I think we're as in a nice quarter. Just wanted to dig a little bit more into the process of patients passing through or working their way through the RYZUP system. And can you give us a little bit more detail in terms of the percentage of patients that start in RYZUP that actually initiate therapy?

我認為我們正處於一個美好的季度。只是想更深入地了解患者透過 RYZUP 系統或透過 RYZUP 系統工作的過程。您能否為我們提供更多關於開始 RYZUP 並實際開始治療的患者百分比的詳細資訊？

Matt, thanks for the question. As far as process is concerned, it's really sort of broken up into 3 key steps. The first is really the enrollment form, which is almost synonymous with the prescription really beginning the process. And that really getting is going, where then the next phase is really the benefits investigation, where they sort of checking out the insurance that the patient has. And including that amount of time is going to be very depending on whether or not there's coverage or not. .

馬特，謝謝你的提問。就流程而言，它實際上分為 3 個關鍵步驟。第一個是登記表，它幾乎與真正開始該過程的處方同義。真正的進展正在進行，下一階段實際上是福利調查，他們會檢查患者擁有的保險。包括這段時間將很大程度上取決於是否有覆蓋範圍。 。

But then the third step is in the process is when the specialty pharmacies get to be involved and they begin to triage the patients to ultimately confirm the shipment date with the patients.

但過程的第三步是專業藥房參與其中，他們開始對患者進行分類，最終與患者確認發貨日期。

So those are what we call are really placenta processes, maybe one that's a little bit unique to us is one last requirement that is aligned to our REMS process as well as specialty pharmacies for LUMRYZ have to confirm whether or not there's an overlay of treatment with another oxybate. So that does take a little bit longer, adds a little bit to the process, but those are really the 3 key steps that go forward.

因此，這些就是我們所說的真正的胎盤過程，也許對我們來說有點獨特的是與我們的 REMS 過程一致的最後一項要求，以及 LUMRYZ 的專業藥房必須確認是否存在與另一種羥丁酸。所以這確實需要更長的時間，增加了一些流程，但這些確實是前進的 3 個關鍵步驟。

And what we can say is our processes are working very well. We're seeing that with the fulfillment today. And we do expect the time lines for fill rates to continue to improve as well.

我們可以說我們的流程運作得很好。我們今天看到了這一點的應驗。我們確實預期填充率的時間軸也會繼續改善。

And your second question again, Matt?

你的第二個問題又來了，馬特？

And kind of the percentage of patients that actually that enter the RYZUP and then initiate therapy at this point?

實際上進入 RYZUP 然後在此時開始治療的患者百分比是多少？

Yes. I mean, the way we can sort of maybe do the math right now sort of go through where we are thus far is like, we announced over 1,000 enrollments through September, 400 initiated. And I think Greg also had some commentary also on the 600 patients were in the process. What we see first is we've seen very few of those drop out, and we do expect going forward that the majority of these remaining 600 or patients to be initiated onto LUMRYZ. So the numbers are some of the math is somewhere between those numbers there as well.

是的。我的意思是，我們現在可以做數學計算，看看我們到目前為止的情況，我們宣布截至 9 月有超過 1,000 名學生註冊，其中 400 名已啟動。我認為格雷格也對這個過程中的 600 名患者發表了一些評論。我們首先看到的是，很少有人退出，我們確實預計，剩下的 600 名患者中的大多數將開始使用 LUMRYZ。所以這些數字中的一些數學也介於這些數字之間。

We also expect the majority of those to be initiated on to reimbursed product as well. So once again, like it's -- these are probably the parts that are the most focal point for us early on the launch, but we're really pleased with the progress that we've made. We're pleased that we're actually getting patients on to LUMRYZ. And as we said, we believe that our conversion rates will just improve as time goes on as well.

我們也預計其中大多數也將針對可報銷的產品啟動。所以，再說一次，這些可能是我們在發布初期最關注的部分，但我們對我們所取得的進展感到非常滿意。我們很高興能夠真正讓患者使用 LUMRYZ。正如我們所說，我們相信隨著時間的推移，我們的轉換率也會提高。

And in terms of the time to move through the RYZUP process, do you expect that to improve as similarly with getting the preferred position with CVS starting at the beginning of the year, with other payers coming online as well and moving to a preferred position? Or do you think it would kind of still remain the same in terms of kind of 1 month to treatment for prior auth patients?

就完成 RYZUP 流程的時間而言，您是否預計會像從年初開始獲得 CVS 的優先位置那樣有所改善，其他付款人也會上線並轉移到優先位置？或者您認為對於先前的 auth 患者來說，就 1 個月的治療時間而言，它仍然會保持不變嗎？

Yes. It's a great comment, Matt. Yes, I think you sort of nailed it. First is sort of that mix, the sort of patients coming through with coverage versus those who don't. And obviously, we sort of see the covered lives continue to improve as we go forward here as well. So yes, that should actually improve our overall time lines.

是的。這是一個很好的評論，馬特。是的，我認為你已經做到了。首先是這種混合，即接受保險的患者與未接受保險的患者。顯然，隨著我們在這裡前進，我們也看到了覆蓋範圍內的生活繼續改善。所以，是的，這實際上應該改善我們的整體時間線。

And then what happens as well, as the offices just get more experienced and more familiar with our process. So both of those are occurring, it's very dynamic, but we see both of those as drivers for us to improve our efficiency going forward.

然後也會發生什麼，因為辦公室變得更有經驗並且更熟悉我們的流程。因此，這兩種情況都在發生，而且非常動態，但我們認為這兩者都是我們提高未來效率的驅動力。

And then maybe last question. One of the goals you have is expanding the existing oxybate prescriber base. Obviously, that's a longer-term goal, we are very early in the launch. But can you tell us a little bit about what you're seeing so far early in the launch in terms of expanding the prescriber base to new prescribers?

然後也許是最後一個問題。您的目標之一是擴大現有的羥丁酸鹽處方者基礎。顯然，這是一個長期目標，我們還處於發布的早期階段。但您能否告訴我們一些您在推出初期在將處方者基礎擴展到新處方者方面所看到的情況？

Yes. Sure, Matt. Right now, at the beginning of the launch, we're much more hyper-focused on those with oxybate experience and the 1,600 who have -- who manage 80% of total prescription volume.

是的。當然，馬特。目前，在推出之初，我們更加關注那些擁有羥丁酸經驗的人以及 1,600 名擁有羥丁酸經驗的人——他們管理著總處方量的 80%。

But here's what's been going on. First, you go into office, there may be someone who had previously never prescribed, that now you want to come in the mix when we've been going in to see one of the more highly experienced oxybate prescriber. But the other thing that's been going on is we've just sort of seen spontaneous people coming to our REMS certification that we hadn't called on, who have put their hand up and have begun the enrollment process as well.

但這就是正在發生的事情。首先，你進入辦公室，可能有人以前從未開過處方，現在當我們去見一位經驗更豐富的羥丁酯處方醫生時，你想加入其中。但另一件正在發生的事情是，我們看到一些自發性的人來參加我們的 REMS 認證，雖然我們沒有邀請他們，但他們已經舉手並開始了註冊程序。

So although it's not been a focal point for us, it's been nice for us to sort of see people coming out of the woodwork that maybe weren't really in our intention to call on as well. So we're going to stay hyper-focused on where sort of the oxybate volume is today. But clearly, as time goes on, we see the opportunity to gain more people to come into the prescribing base as well.

因此，雖然這不是我們的焦點，但我們很高興看到人們從木製品中走出來，而這些人可能不是我們真正打算拜訪的。因此，我們將高度關註今天的含氧酸鹽量。但顯然，隨著時間的推移，我們看到了讓更多人進入處方基地的機會。

Our next question comes from Francois Brisebois from Oppenheimer.

我們的下一個問題來自奧本海默的弗朗索瓦·布里斯布瓦。

Congrats on the early progress here. Can you maybe touch on -- we talked about the 3 buckets of patients and where they're coming from. But can you maybe help us understand how the AGs are maybe affecting each bucket and what you're seeing so far in terms of a patient going through an authorized generic first?

祝賀這裡的早期進展。您能否談談—我們討論了三類患者以及他們來自哪裡。但您能否幫助我們了解 AG 可能如何影響每個桶，以及您到目前為止在患者首先使用授權仿製藥方面所看到的情況？

Yes. Frank, thanks for the question. So yes, super pleased with the progress so far. And it's nice that we are seeing enrollment in the ones coming from all 3 of those patient buckets, as you mentioned. So Obviously, what's been nice is from all 3 segments. But the AG overall, we are actually also converting patients who are currently on AG coming on to LUMRYZ. And as far as discontinues, we have seen that many AGs who have discontinued to have been relatively new. So the source of the AGs is predominantly coming from those who are switching from an oxybate. And we are also seeing, clearly, naive patients never being exposed to any first-generation oxybate as well.

是的。弗蘭克，謝謝你的提問。所以，是的，對迄今為止的進展非常滿意。正如您所提到的，很高興我們看到來自所有 3 個患者群體的註冊。顯然，這三個部分都很好。但總體而言，我們實際上也在將目前接受 AG 治療的患者轉為 LUMRYZ。就停產而言，我們發現許多停產的 AG 都相對較新。因此，AG 的來源主要來自那些從羥丁酸轉換而來的人。我們也清楚地看到，初次接受治療的患者也從未接觸過任何第一代羥丁酸。

So it's still a bit early, but the real source for us where AGs are concerned are these switching from current oxybate patients. And we really haven't sort of seen what I would tell as seen as an impediment of AGs impacting the ability to get on to LUMRYZ thus far.

所以現在還為時過早，但對我們來說，AG 所關心的真正來源是這些從目前的羥丁酸鹽患者轉變而來的。到目前為止，我們確實還沒有看到我所說的 AG 障礙會影響進入 LUMRYZ 的能力。

Our next question comes from Marianne Belgie with LifeSci Capital.

我們的下一個問題來自 LifeSci Capital 的 Marianne Belgie。

Congratulations on the progress. So my question is around payers. Congratulations again on gaining preferred status with CVS. Just can you provide a little more detail with regard to discussions with theirs? And if you have any kind of what's your expectation for other payers when it comes to preferred status? Is this something you're actively trying to achieve?

祝賀取得的進展。所以我的問題是關於付款人的。再次恭喜您獲得 CVS 的優先地位。您能否提供有關與他們討論的更多細節？如果您對其他付款人的優先地位有何期望？這是您正在積極努力實現的目標嗎？

And quick other question, just more color on the pediatric opportunity. What are the main reasons there for not taking an oxybate? And are the dynamics different from adults when it comes to both sodium and middle of the night dosing?

還有一個問題，就是對兒科機會有更多的了解。不服用羥丁酯的主要原因是什麼？在鈉和半夜服藥方面，動態與成人有什麼不同嗎？

Sure, Martha. I'll start with the payer question. So yes, our overall strategy with payers has been to sort of have unencumbered access through any oxybate to sort of be at the best sort of status with the best of the oxybate thus far. So thus far, with the first 3 of the GPO contracts, that's what we've achieved, and that is our goal going forward as well.

當然，瑪莎。我將從付款人問題開始。所以，是的，我們與付款人的總體策略是透過任何 oxybate 不受阻礙地訪問，以達到迄今為止最好的 oxybate 的最佳狀態。到目前為止，我們已經透過前 3 份 GPO 合約實現了目標，這也是我們未來的目標。

I mentioned the fact that we have ongoing conversations with MSR and the United Optum lives. So whatever is the best status, which is generally a preferred status for oxalate, that is our goal. And thus far, we've been very pleased with what we've been achieving thus far.

我提到我們正在與 MSR 和 United Optum Lives 進行對話。因此，無論最佳狀態是什麼，這通常是草酸鹽的首選狀態，這就是我們的目標。到目前為止，我們對迄今為止所取得的成就感到非常滿意。

I'll turn the pediatric question over to Jen.

我會把兒科問題轉給珍。

Thanks so much for the interest in pediatrics. We have heard for years now of the desperate need for a pediatric form of sodium oxybate that does not require waking up in the middle of the night. That has been the primary driver for an expanded indication.

非常感謝您對兒科的興趣。多年來，我們一直聽說迫切需要一種無需半夜醒來的兒科羥丁酸鈉。這是擴大適應症的主要驅動力。

In regard to whether it's different, the clinical needs compared to adults. While it's really important for adults to not have to chronically wake up, and it's true that sometimes an adult patient waking up, they also wake up their bed partner. The reality is for children who are 7 to 17, they are typically having at least one parent, if not both parents, chronically waking up in the middle of the night to administer the dose.

至於是否不同，臨床上需要與成人相比。雖然對於成年人來說，不必長期醒來確實很重要，但確實，有時成年患者醒來時，他們也會吵醒他們的床伴。現實情況是，對於 7 至 17 歲的兒童來說，他們通常至少有一個父母（如果不是父母雙方）長期在半夜醒來服用藥物。

I've had conversations with parents who were happy to submit letters of support for the pediatric supplement, describing how challenging it was to never have an uninterrupted night's sleep for those children and for themselves.

我與一些家長進行了交談，他們很樂意提交對兒科補充劑的支持信，描述了對於這些孩子和他們自己來說，永遠無法獲得不間斷的夜間睡眠是多麼具有挑戰性。

For the second part of the question in regard to sodium. What we see with clinicians is they may identify a very small subset of their adult population who they consider to be sodium sensitive. This has not been an issue as we've been discussing sodium with the many KOLs to import us to bring this option to them as quickly as possible.

關於鈉的問題的第二部分。我們從臨床醫生那裡看到的是，他們可能會在成年人口中識別出一小部分他們認為對鈉敏感的人。這並不是一個問題，因為我們一直在與許多 KOL 討論鈉的進口問題，以便盡快為他們帶來這個選擇。

Yes. The only thing I would add regarding pediatrics is really just I would characterize it as unbelievably consistent, albeit anecdotal, which is every time you talk to a physician about LUMRYZ in narcolepsy, the next 2 questions you get from them universally, is "When are you going to get pediatrics and when are you going to study it in IH?" So it's very consistent when we talk to doctors about that. So hence, why we're going down those paths.

是的。關於兒科，我唯一要補充的是，我將其描述為令人難以置信的一致，儘管是軼事，每次您與醫生談論嗜睡症中的LUMRYZ 時，您從他們那裡得到的下兩個普遍問題是“什麼時候你要學兒科，什麼時候在 IH 學習兒科？”因此，當我們與醫生談論這一點時，情況非常一致。因此，這就是為什麼我們要走這些路。

Our next question comes from David Amsellem from Piper Sandler.

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

Just a few here. One is can you talk about sales force sizing longer term? And also how you're thinking about any DTC spend (inaudible) view that your competitor (inaudible) disease awareness lay the groundwork for you with its initiatives. Talk about that. And that's number one.

這裡只是一些。一是您能談談長期銷售人員規模的問題嗎？以及您如何看待 DTC 支出（聽不清楚）的觀點，即您的競爭對手（聽不清楚）的疾病意識為您的舉措奠定了基礎。談談那個。這是第一名。

Number two is, I may have missed this. Can you talk about the mix between [NT1, NT2]? Are you getting any traction in one subgroup versus another? And what's your expectation regarding the mix between the 2 going forward?

第二是，我可能錯過了這一點。可以談談[NT1，NT2]之間的混合嗎？與另一個小組相比，您在一個小組中是否受到關注？您對兩者未來的組合有何期望？

Yes. Thanks, David. So as far as sales force size is concerned, to your point today, we're at 49 sales representatives. We also have our field reimbursement team. Once again (inaudible) really going against the opportunity for oxybate right now, that 4,500 prescribers, our 49 representatives sort of allow us to cover up to about 6,000, maybe 6,500 physicians. So that gives us the space to cover our current opportunity and benefit.

是的。謝謝，大衛。就銷售隊伍規模而言，就您今天所說的而言，我們有 49 位銷售代表。我們還有我們的現場報銷團隊。再次（聽不清楚）現在確實違背了羥丁酸的機會，4,500 名處方者，我們的 49 名代表讓我們能夠覆蓋大約 6,000 名，也許 6,500 名醫生。因此，這為我們提供了涵蓋當前機會和利益的空間。

I'd say longer term, I mean, right now, that's pretty where our focal point is, is getting oxybate-experienced prescribers comfortable with using LUMRYZ as well. Longer term, we'll sort of see what the mix is. But I would say, for the foreseeable future, we really don't see the need to expand the size of our sales force.

我想說，從長遠來看，我的意思是，現在我們的重點是讓有羥丁酸鹽經驗的處方者也能適應使用 LUMRYZ。從長遠來看，我們將看看其中的組合是什麼。但我想說，在可預見的未來，我們確實認為沒有必要擴大銷售隊伍的規模。

Now when it comes to DTC, we wouldn't really call it more sort of patient activation and patient media here. First, any news and media on narcolepsy, we think, is a good thing for a rare condition. Secondarily, our plans have really been to try to meet patients where they are, and they spend a lot of time digitally being active as well. So we've been very targeted about placing media and engagement through the sources where they go, Reddit, Facebook and other sources. And we have a couple of other novel approaches that we're doing in and around sleep specialist offices as well. So our approach with patients is, I would say, a little bit more surgical than as a cost shop approach.

現在，當談到 DTC 時，我們實際上不會將其稱為更多類型的患者啟動和患者媒體。首先，我們認為，任何有關發作性睡病的新聞和媒體對於罕見的疾病都是一件好事。其次，我們的計劃實際上是嘗試與患者見面，他們也花了很多時間進行數位化活動。因此，我們非常有針對性地透過 Reddit、Facebook 和其他來源等來源來放置媒體和參與度。我們還在睡眠專家辦公室及其周圍採取了其他一些新穎的方法。因此，我想說，我們對待患者的方法比成本店方法更手術。

And as far as the NT1, NT2 is concerned, and it's a little bit level from our data as you're looking to that. But what we know historically is even though the prevalence shows about a 30% NT1 70% in Q2. For oxybate, it actually historically has been the exact opposite use of 70% MT102. So I think maybe in the future, we can provide some insight into some of those trends as more usage with LUMRYZ increases.

就 NT1、NT2 而言，它與我們的數據有一點水平，正如您所看到的那樣。但我們從歷史上知道，儘管第二季的 NT1 盛行率約為 30% 至 70%。對於羥丁酸，歷史上實際上與 70% MT102 的用途完全相反。因此，我認為也許在未來，隨著 LUMRYZ 使用量的增加，我們可以對其中一些趨勢提供一些見解。

Our next question comes from Chase Knickerbocker with CH.

我們的下一個問題來自 CH 的 Chase Knickerbocker。

Just first -- I wanted to ask another question. Sorry to belabor the point here on pull-through from RYZUP. Maybe just asking a different way, if you look specifically, at the patients within the 400 that were on RYZUP that exited Q2 not on therapy. What was the conversion percentage specifically with those patients within Q3?

首先——我想問另一個問題。很抱歉在此詳細說明有關 RYZUP 拉通的問題。如果你具體觀察 400 名接受 RYZUP 治療但退出第二季度而不是接受治療的患者，也許只是以不同的方式詢問。第三季內這些患者的具體轉換百分比是多少？

Yes. Chase, the majority of those patients who were enrollments at the end of our Q2 or going to Q3s did convert on to product. Now we haven't given specifics on the exact percentage because some of it is dynamic. I'll give you one example.

是的。 Chase，大多數在第二季末註冊或進入第三季度的患者確實轉向了產品。現在我們還沒有給出確切的百分比細節，因為其中一些是動態的。我給你舉一個例子。

We have patients who enrolled in June who just got reimbursed and shipped product in October. So when we think about those 2 sort of buckets of covered lives versus not, the covered lives going through will be quicker than those who aren't. Our digital philosophy is if a physician prescribes LUMRYZ going to go to the end of the earth to get them on that. If we see a fair path forward. And like I said, we have examples of June enrollments taking unfortunately foresee several months, but actually getting them in process. as well. So I think it's still dynamic. So the majority did, and we just receive with more time that, that number should be increasing from that cohort and every cohort as well.

我們有 6 月入組的患者，他們剛剛在 10 月獲得報銷並發貨。因此，當我們考慮這兩種類型的受保生命與非受保生命時，受保生命的經驗會比那些沒有受保的生命經歷得更快。我們的數位理念是，如果醫生開出 LUMRYZ 處方，他就會去天涯海角讓他們接受治療。如果我們看到一條公平的前進道路。就像我說的，我們有一些例子，不幸的是，六月的入學需要幾個月的時間，但實際上正在處理中。以及。所以我認為它仍然是動態的。所以大多數人都這麼做了，而且我們只是隨著時間的推移發現，該群體以及每個群體的數字應該會增加。

Is there an amount of time where they're on within RYZUP that you do start to see some drop outs? Is there like is it 3 months? Is it 4 months?

他們在 RYZUP 中存在一段時間後，您是否會開始看到一些人退出？有沒有3個月之類的？是4個月嗎？

And then just another quickly. Any feedback from the field as far as anecdotal kind of experiences with how the titrating has gone for new patients, and whether or not there's a difference for whether or not a patient has been experienced with the first-gen sodium oxybate for years versus they've been on it for 6 months? Any sort of color there would be helpful.

然後又很快。來自該領域的任何反饋，例如關於新患者的滴定如何進行的軼事體驗，以及患者多年來使用第一代羥丁酸鈉的經歷與他們相比是否存在差異。已經使用了6 個月了嗎？任何顏色都會有幫助。

Yes. Starting with the titration for the new patients. I would sort of say from the physician that tends to be a bit of a mix. Sometimes you have slow titrators who want to sort of take their time to sort of get up to that. And I think on the other side, you have people who get there a little bit more quickly. And I think that predominantly position depending on sort of their approach. So it's been a bit of a mixed bag. Sorry, Chase, what was your first question again?

是的。從新患者的滴定開始。我想說的是，醫生的說法往往有點複雜。有時，你的滴定儀速度很慢，他們想花點時間來完成這個任務。我認為另一方面，人們可以更快到達那裡。我認為這主要取決於他們的方法。所以這有點魚龍混雜。抱歉，蔡斯，你的第一個問題是什麼？

On just for those patients that you do see dropout of RYZUP, even if it is a small number, they're like in a number of months that they -- you start to see some fallouts or has there not really been a clear trend there.

僅針對那些您確實看到 RYZUP 退出的患者，即使數量很少，他們也會在幾個月後 - 您開始看到一些後果，或者那裡沒有真正出現明顯的趨勢。

Yes. No, no. I mean, we're sort of getting to that time where some is for new enrollment, they may tend to drop out a bit. Some of that may be after exhaustion of going through the medical necessity pathway or from the patient. So we will start to see some of those patients start to drop of here as more combos gone by. From past launches, what may happen is they may revisit the conversation again in their next visit with their sleep specialist again. But definitely, after some period of time, the success rate, after sort of 4 or 5 months, definitely starts to go down.

是的。不，不。我的意思是，我們即將迎來一些新註冊的時代，他們可能會稍微退出。其中一些可能是在經歷了醫療必要性途徑或患者精疲力竭之後。因此，隨著更多組合的消失，我們將開始看到其中一些患者開始離開這裡。從過去的發布來看，可能會發生的情況是，他們可能會在下次與睡眠專家會面時再次重新討論對話。但肯定的是，經過一段時間後，大概四、五個月之後，成功率一定會開始下降。

Yes. I would just add that to your question around the 400 cohort, we're very pleased with the percent that has converted. We described it as the majority. But I think across all cohorts, there's an opportunity to continue to get better.

是的。我只想將這一點添加到您關於 400 人的問題中，我們對轉換的百分比感到非常滿意。我們將其描述為大多數。但我認為所有群體都有機會繼續變得更好。

And when someone decides to -- predominantly when someone decides to exit RYZUP, it really is 1 of 2 reasons. It's just the payer denial that we haven't been able to get over or that patient has gone through the process and then at the end decided they're not going to go on therapy, right? Which happens. It happens for all therapies.

當有人決定退出 RYZUP 時，主要是當有人決定退出 RYZUP 時，這確實是兩個原因之一。這只是我們無法克服的付款人否認，或者患者已經完成了整個過程，然後最終決定他們不打算繼續治療，對嗎？發生這種情況。所有療法都會發生這種情況。

So -- but again, that's a relatively small percentage as we've described. And we're pleased with people sticking with it and the conversion rates we've seen early on. And knowing that those opportunities will only get better and they're already coming from a really good places.

所以——但同樣，正如我們所描述的，這個比例相對較小。我們對人們堅持使用它以及我們早期看到的轉換率感到滿意。並且知道這些機會只會變得更好，而且它們已經來自一個非常好的地方。

Thank you. This concludes our question-and-answer session. I would now like to turn it back to Greg Divis, for closing comments.

謝謝。我們的問答環節到此結束。我現在想把它轉回給格雷格·迪維斯，請其發表最後評論。

Thank you, and thanks, everyone, for your time and for joining us today on our third quarter 2023 call. We wish you a great rest of the day and look forward to follow up. Take care.

謝謝大家，也謝謝大家抽出寶貴時間參加我們今天舉行的 2023 年第三季電話會議。我們祝您今天休息愉快，並期待後續跟進。小心。

This does conclude the program. You may now disconnect.

這確實結束了該程式。您現在可以斷開連線。