Avadel Pharmaceuticals PLC (AVDL) 2023 Q4 法說會逐字稿

Greetings, and welcome to Avadel Pharmaceuticals's fourth quarter and full-year 2023 earnings call.

您好，歡迎參加 Avadel Pharmaceuticals 的第四季和 2023 年全年財報電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（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.

現在我很高興向史特恩投資者關係部介紹奧斯汀·默塔。

You may begin.

你可以開始了。

Good morning, and thank you for joining us on our conference call to discuss Avadel's fourth quarter and full-year 2023 earnings.

早安，感謝您參加我們的電話會議，討論 Avadel 的第四季度和 2023 年全年收益。

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.

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。

This includes statements related to expectations regarding revenue, operating expenses, and operating breakeven.

這包括與收入、營運支出和營運收支平衡預期相關的報表。

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.

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有重大差異。

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, 2023, which was filed on February 29, 2024, and subsequent SEC filings.

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，其中包含於2024 年2 月29 日提交的截至2023 年12 月31 日的年度10-K 表格以及隨後向SEC提交的文件。

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.

除法律要求外，Avadel 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。

For purposes of this conference call, the company made the decision to provide certain leading launch indicators as of January 31, 2024, in order to provide a more current snapshot of its launch progress, and in consideration of the update the company provided in early January.

出於本次電話會議的目的，該公司決定提供截至 2024 年 1 月 31 日的某些領先發布指標，以便提供其發布進度的最新快照，並考慮到該公司 1 月初提供的更新。

Avadel undertakes no obligation to provide intra-quarter results in future quarters.

Avadel 不承擔在未來幾季提供季度內業績的義務。

On the call today are Greg Divis, Chief Executive Officer; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer.

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。

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.

謝謝你，奧斯汀。

Good morning, everyone, and thank you for joining us for a company update and to review Avadel's fourth quarter and full-year 2023 results.

大家早安，感謝您接受我們的公司更新並回顧 Avadel 的第四季度和 2023 年全年業績。

Following my brief opening remarks, Richard will provide an update on our launch progress, including our key metrics through January 31.

在我簡短的開場白之後，Richard 將提供我們發布進度的最新信息，包括截至 1 月 31 日的關鍵指標。

Tom will then review our Q4 financial results and provide some commentary regarding 2024.

然後，Tom 將回顧我們第四季度的財務業績，並提供一些有關 2024 年的評論。

We will conclude with a question-and-answer session.

我們將以問答環節結束。

As most of you are likely aware, it's been a busy several days for Avadel, especially last week with the ongoing patent trial in Delaware where closing arguments were heard this past Friday and we are now awaiting the jury's decision.

你們大多數人可能都知道，這幾天對Avadel 來說是忙碌的幾天，尤其是上週特拉華州正在進行的專利審判，上週五聽取了結案陳詞，我們現在正在等待陪審團的決定。

So before we dive into the commercial and business updates announced in our press release this morning, I would like to take a moment to provide some general commentary as it relates to the current and still active patent dispute.

因此，在我們深入了解今天早上新聞稿中宣布的商業和業務更新之前，我想花點時間提供一些與當前且仍然活躍的專利糾紛相關的一般性評論。

Regardless of the outcome, we don't expect the pending jury decision in the patent trial to impact our ongoing commercial launch or our belief in the potential of LUMRYZ.

無論結果如何，我們預計陪審團在專利審判中的裁決將不會影響我們正在進行的商業發布或我們對 LUMRYZ 潛力的信心。

Given this is an active litigation, we will not provide any further commentary or answer any questions on the trial, the underlying dispute, or the pending decision at this time.

鑑於這是一項正在進行的訴訟，我們目前不會提供任何進一步的評論或回答有關審判、潛在爭議或待決決定的任何問題。

However, as we have with all key matters, we will provide an update when the trial concludes and we appreciate your understanding on this point.

然而，正如我們對所有關鍵問題所做的那樣，我們將在審判結束時提供最新信息，感謝您對這一點的理解。

2023 was truly a monumental year for Avadel.

2023 年對 Avadel 來說確實是具有里程碑意義的一年。

With final FDA approval, we were able to bring LUMRYZ through the narcolepsy community and execute our initial launch plan, both of which have been transformational for the company and that we have worked towards for many years.

憑藉 FDA 的最終批准，我們能夠將 LUMRYZ 引入嗜睡症社區並執行我們最初的上市計劃，這兩項計劃對公司來說都是變革性的，也是我們多年來一直努力的目標。

In addition to the unmatched achievement of launching LUMRYZ within approximately one month of final FDA approval, since launch last June, LUMRYZ has seen strong uptake among patients and prescribers, which has been supported by the positive feedback we've received from the broader narcolepsy community.

除了在FDA 最終批准後大約一個月內推出LUMRYZ 所取得的無與倫比的成就外，自去年6 月推出以來，LUMRYZ 已在患者和處方者中得到了強烈的接受，這得到了我們從更廣泛的嗜睡症社群收到的正向回饋的支持。

Our early launch momentum throughout 2023 has continued into this year as demonstrated by progress being made across physicians, patients, and payers, all of which Richard will provide further details on shortly.

我們在 2023 年早期推出的勢頭一直持續到今年，醫生、患者和付款人之間的進展證明了這一點，理查德將很快提供所有這些進展的詳細信息。

Our team's nearly decade-long dedication to advancing LUMRYZ and to the sleep medicine space overall has allowed us to build a foundation for continued growth and the potential expansion of LUMRYZ.

我們的團隊近十年來致力於推進 LUMRYZ 和整個睡眠醫學領域，這使我們能夠為 LUMRYZ 的持續成長和潛在擴張奠定基礎。

And as such, our priorities as a company remain very crystal clear.

因此，作為一家公司，我們的優先事項仍然非常明確。

First and foremost, continues to be our focus on executing our launch strategy and delivering on the promise and the potential of LUMRYZ across the multibillion-dollar oxybate market opportunity.

首先也是最重要的，我們仍然專注於執行我們的上市策略，並在數十億美元的羥丁酸市場機會中兌現 LUMRYZ 的承諾和潛力。

We are proud of the momentum we are building and all we have accomplished thus far.

我們為我們正在形成的勢頭以及迄今為止所取得的一切感到自豪。

And this is evidenced by the $19.5 million in LUMRYZ net revenue in the fourth quarter, and the $28 million for the seven months ended December 31, 2023.

LUMRYZ 第四季淨收入為 1,950 萬美元，截至 2023 年 12 月 31 日的七個月淨收入為 2,800 萬美元，就證明了這一點。

Our second and near-term opportunity is our potential expansion into the pediatric narcolepsy population.

我們的第二個也是近期的機會是我們有可能擴展到兒科發作性睡病人群。

The FDA accepted our supplemental New Drug Application for LUMRYZ for the treatment of cataplexy, or excessive daytime sleepiness in patients between the ages of 7 to 17 with narcolepsy, and provided us an action date of September 7, 2024.

FDA 接受了我們的 LUMRYZ 補充新藥申請，用於治療 7 至 17 歲發作性睡病患者的猝倒或白天過度嗜睡，並向我們提供了 2024 年 9 月 7 日的行動日期。

We believe approval in the pediatric population will allow LUMRYZ to provide further positive impact to the narcolepsy community and caregivers at large.

我們相信，在兒科族群中獲得批准將使 LUMRYZ 能夠為發作性睡病社區和廣大護理人員帶來進一步的正面影響。

We have heard directly from parents about the challenges associated with the middle of the night dosing, and the burden of twice nightly dosing regimen may create for the entire family.

我們直接從家長那裡聽到有關半夜給藥的挑戰，以及每晚兩次給藥方案可能給整個家庭帶來的負擔。

We believe LUMRYZ, if approved for the pediatric population, can offer the potential of reducing that treatment burden, while also providing an effective treatment for children living with narcolepsy.

我們相信，LUMRYZ 如果被批准用於兒科族群，可以減輕治療負擔，同時也為患有發作性睡病的兒童提供有效的治療。

We look forward to the potential approval and launch later this year.

我們期待今年稍後的潛在批准和推出。

The next growth opportunity we're pursuing is LUMRYZ for the treatment of idiopathic hypersomnia, or IH.

我們正在尋求的下一個成長機會是用於治療特發性睡眠過多（IH）的 LUMRYZ。

When speaking with key opinion leaders in the field, there is a significant need for the use of once-at-bedtime LUMRYZ for many suffering from the deep sleep inertia associated with IH.

在與該領域的主要意見領袖交談時，發現許多患有與 IH 相關的深度睡眠慣性的人非常需要在睡前使用一次 LUMRYZ。

With a current estimated uniquely diagnosed IH patient population of greater than 30,000, we believe LUMRYZ, if approved for the IH indication, will be an important addition to the treatment options for those suffering from this rare sleep disorder, while also providing potentially meaningful upside to the future value of LUMRYZ.

目前估計獨特診斷的 IH 患者人數超過 30,000 人，我們相信 LUMRYZ 如果被批准用於 IH 適應症，將成為患有這種罕見睡眠障礙的患者的治療選擇的一個重要補充，同時也為LUMRYZ 的未來價值。

We are currently well advanced in the planning stages to initiate a multicenter randomized controlled trial for IH in the second half of this calendar year, and we intend to provide updates as we reach various important milestones, including when our first patient is enrolled.

目前，我們在計劃階段已取得進展，將於今年下半年啟動 IH 多中心隨機對照試驗，我們打算在達到各個重要里程碑時提供最新信息，包括當我們的第一位患者入組時。

And lastly, we're continuing the preclinical development work of a potential no- or low-sodium once-at-bedtime oxybate formulation with a target product profile that is bioequivalent to LUMRYZ.

最後，我們正在繼續潛在的無鈉或低鈉睡前一次羥丁酯製劑的臨床前開發工作，其目標產品特徵與 LUMRYZ 生物等效。

And we intend to provide those updates as appropriate as well.

我們也打算在適當的時候提供這些更新。

In closing, we ended this year in a strong position with a healthy balance sheet to support our operations and our continued growth.

最後，我們在今年結束時處於有利地位，擁有健康的資產負債表來支持我們的營運和持續成長。

Coupled with the progress already made this year, we believe we're well positioned to expand our reach and impact within the sleep medicine space, and most importantly, continue executing the launch of LUMRYZ.

加上今年已經取得的進展，我們相信我們已經做好了充分準備，可以擴大我們在睡眠醫學領域的影響力和影響力，最重要的是，繼續推出 LUMRYZ。

I am proud of the significant accomplishments and progress our team has delivered over the past year, and remain highly confident that we will continue that during the year ahead.

我對我們的團隊在過去一年中取得的重大成就和進步感到自豪，並對我們在未來一年繼續保持這一目標充滿信心。

We believe we are well positioned to advance LUMRYZ to command a meaningful share of the multibillion dollar oxybate market, and maintain our view that LUMRYZ offers a greater than $1 billion potential market opportunity.

我們相信，我們有能力推動 LUMRYZ 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 LUMRYZ 提供了超過 10 億美元的潛在市場機會。

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

這樣，我會將電話轉給理查德，以了解我們商業進展的詳細資訊。

Richard?

理查德？

Hey, thanks, Greg, and good morning, everyone.

嘿，謝謝格雷格，大家早安。

I'm excited to share our launch progress and provide some insight into the trends we saw develop as we ended 2023 and early into this year.

我很高興與大家分享我們的發布進展，並就 2023 年底和今年年初我們所看到的發展趨勢提供一些見解。

Now, taking a step back and looking at what we achieved this past year, we are so proud to be part of a team that has been able to bring a life changing treatment to the narcolepsy community.

現在，退後一步，看看我們過去一年所取得的成就，我們非常自豪能夠成為這個團隊的一員，這個團隊能夠為發作性睡病社區帶來改變生活的治療方法。

The positive feedback we hear from both people with narcolepsy and healthcare providers every day continues to be an inspiration for us.

我們每天從發作性睡病患者和醫療保健提供者那裡聽到的積極回饋仍然是我們的靈感。

Greg touched on this earlier, but our LUMRYZ commercial results continue to be strong since we launched last June, and we remain laser focused on keeping the momentum growing in 2024.

Greg 早些時候談到了這一點，但自去年 6 月推出以來，我們的 LUMRYZ 商業業績繼續強勁，我們仍然專注於在 2024 年保持成長勢頭。

Starting with patients, RYZUP enrollments are an important indicator of early launch demand, as it is really the first step in the process for patients to receive their LUMRYZ prescription.

從患者開始，RYZUP 註冊量是早期啟動需求的重要指標，因為這實際上是患者接受 LUMRYZ 處方過程的第一步。

We previously stated that as of December 31, there were over 1,900 patients enrollment to RYZUP.

我們先前曾表示，截至 12 月 31 日，已有 1,900 多名患者註冊加入 RYZUP。

Since that time, we've continued to see strong demand with now greater than 2,200 patient enrollments through the end of January.

自那時起，我們持續看到強勁的需求，截至 1 月底已有超過 2,200 名患者註冊。

Turning to patients who have initiated therapy, as of December 31, there were 1,000 patients who had initiated the LUMRYZ treatment and that number grew to greater than 1,200 by the end of January.

至於已開始治療的患者，截至 12 月 31 日，已有 1,000 名患者開始 LUMRYZ 治療，到 1 月底，這一數字已增至 1,200 多人。

Typically, the start of the year can be more complicated to initiate new therapies, so we were pleased to see that we did not lose any momentum in getting new LUMRYZ patients started.

通常，年初啟動新療法可能會更加複雜，因此我們很高興看到我們在啟動新的 LUMRYZ 患者方面沒有失去任何動力。

Importantly, the majority of these patients are commercially reimbursed.

重要的是，這些患者中的大多數都得到了商業報銷。

When we look at our available RYZUP data, we continue to see all three patient segments switch patients from first-generation oxybates, patients who previously tried and discontinued a first-generation oxybate, and oxybate-naive patients being well represented.

當我們查看可用的RYZUP 數據時，我們繼續看到所有三個患者群體都從第一代oxybates 轉換為患者、之前嘗試過並停用第一代oxybate 的患者以及未使用過oxybate 的患者都有很好的代表性。

We are seeing the majority of initiations come from patients switching from a first-generation oxybate, with more patients coming from the twice nightly mixed salts product, compared to the twice nightly sodium oxybate products.

我們看到大多數起始治療來自第一代羥丁酸鈉產品轉用的患者，與每晚兩次羥丁酸鈉產品相比，更多的患者來自每晚兩次混合鹽產品。

For new to oxybate patients, we saw an increase in their overall representation of all RYZUP patients in Q4 compared to Q3.

對於新使用 oxybate 的患者，我們發現與第三季相比，第四季度所有 RYZUP 患者的整體代表性增加。

We're also excited that in the next few weeks we will be rolling out our LUMRYZ brand ambassador program, where people with narcolepsy will begin to tell their stories of how LUMRYZ has transformed their lives.

我們也很高興在接下來的幾週內推出 LUMRYZ 品牌大使計劃，嗜睡症患者將開始講述 LUMRYZ 如何改變他們的生活的故事。

These stories and messages will come out through various forms of media to get these personal messages about LUMRYZ out to the narcolepsy community.

這些故事和資訊將透過各種形式的媒體發布，以便將有關 LUMRYZ 的個人資訊傳播給嗜睡症社區。

Turning to healthcare providers, as of January 31, there were approximately 1,900 HCPs who are REM certified.

至於醫療保健提供者，截至 1 月 31 日，大約有 1,900 名 HCP 獲得了 REM 認證。

As previously stated, although we covered the 4,500-plus HCPs who make up the entire oxybate prescribing universe, we have been spending more time with the 1,600 high-volume prescribers who make up 80% of the total oxybate market.

如前所述，儘管我們涵蓋了構成整個羥丁酯處方領域的 4,500 多名 HCP，但我們仍將更多時間花在佔整個羥丁酯市場 80% 的 1,600 名大量處方者身上。

Of these prescribers, we have focused more of our early efforts on the almost 500 most experienced prescribers who account for 50% of the overall oxybate market.

在這些處方者中，我們早期的工作更集中在近 500 名最有經驗的處方者身上，他們佔整個羥丁酸鹽市場的 50%。

And greater than 70% of these top tier HCPs have now written a prescription for LUMRYZ.

目前，超過 70% 的頂級 HCP 已開出 LUMRYZ 處方。

Every week, we have been consistently adding more new and repeat writers.

每週，我們都會不斷增加更多新作家和重複作家。

Additionally, in the fourth quarter, we began our KOL-led speaker programs as they are a key tactic to drive HCP peer-to-peer LUMRYZ education.

此外，我們在第四季度開始了由 KOL 主導的演講者計劃，因為它們是推動 HCP 點對點 LUMRYZ 教育的關鍵策略。

For product fulfillment, we continue to make strong progress demonstrated by the greater than 1,200 patients who have initiated therapy as of January 31.

在產品履行方面，我們繼續取得強勁進展，截至 1 月 31 日已有​​超過 1,200 名患者開始接受治療。

As our overall reimbursement has grown significantly, we are focused on continuing to have more HCPs leverage RYZUP and our field reimbursement team to get more patients initiated onto LUMRYZ and support them longer term on their LUMRYZ journey.

隨著我們的整體報銷顯著增長，我們致力於繼續讓更多 HCP 利用 RYZUP 和我們的現場報銷團隊，讓更多患者開始使用 LUMRYZ，並在 LUMRYZ 旅程中為他們提供長期支持。

In February, we saw continued improvement in progress with our trends.

二月份，我們看到趨勢的進展持續改善。

That's a nice segue for me to provide an update on our payer progress.

對我來說，提供有關付款人進展的最新資訊是一個很好的過程。

We announced that with the signing of the MSR contract, we secured all three GPO contracts last year within the first seven months of launch.

我們宣布，隨著 MSR 合約的簽署，我們去年在啟動後的前七個月內就獲得了所有三份 GPO 合約。

Now, to start 2024, LUMRYZ is now also covered by Anthem and the United Healthcare national formulary.

現在，從 2024 年開始，LUMRYZ 也納入 Anthem 和 United Healthcare 國家處方集的涵蓋範圍。

LUMRYZ now has coverage policies with greater than 80% of commercially covered lives or over 140 million lives.

LUMRYZ 現在的保單涵蓋了超過 80% 的商業承保人或超過 1.4 億人。

With the recent payer wins in hand, positive feedback from sleep specialists and people with narcolepsy, growing momentum and product fulfillment, and strong execution from our team, we believe we are well positioned for long term LUMRYZ growth, and ultimately for LUMRYZ to become the preferred oxybate for people with narcolepsy and HCPs.

憑藉最近的付款人勝利、睡眠專家和發作性睡病患者的積極反饋、不斷增長的勢頭和產品實現以及我們團隊的強大執行力，我們相信我們已為LUMRYZ 的長期增長做好了準備，並最終使LUMRYZ 成為發作性睡病患者和 HCP 患者的首選羥丁酯。

With that, I look forward to providing more updates on future calls.

因此，我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.

現在，我將把電話轉給湯姆，討論我們的財務狀況。

Tom?

湯姆？

Thank you, Richard.

謝謝你，理查。

Before we begin, I'll note that full financial results are available in the press release issued this morning and the 10-K that was filed last week.

在我們開始之前，我要指出的是，完整的財務業績可在今天早上發布的新聞稿和上週提交的 10-K 中找到。

We are pleased to report that we generated $19.5 million in net revenue for the quarter ended December 31, 2023, and $28 million of revenue for the seven months ended December 31, 2023.

我們很高興地報告，截至 2023 年 12 月 31 日的季度淨收入為 1,950 萬美元，截至 2023 年 12 月 31 日的七個月收入為 2,800 萬美元。

And as of December 31, we estimate that there was approximately one month of demand in the channel.

截至 12 月 31 日，我們估計該通路約有 1 個月的需求。

Turning to operating expenses, we reported $43.7 million of total GAAP operating expenses for the fourth quarter of 2023, compared to $28.3 million (sic - see press release, "$23 million") in the fourth quarter of 2022.

談到營運支出，我們報告 2023 年第四季的 GAAP 營運支出總額為 4,370 萬美元，而 2022 年第四季為 2,830 萬美元（原文如此 - 參見新聞稿，「2,300 萬美元」）。

Total operating expenses in the fourth quarter of 2023 includes $4.6 million of non-cash charges comprised of stock based compensation of $3.5 million and depreciation and amortization of $1.1 million.

2023 年第四季的總營運支出包括 460 萬美元的非現金費用，其中包括 350 萬美元的股票薪酬和 110 萬美元的折舊和攤提。

After adjusting for these items, cash operating expenses were approximately $39 million for the quarter.

在這些項目進行調整後，本季現金營運支出約為 3,900 萬美元。

For the full year of 2023, GAAP operating expenses were $165 million compared to $98.6 million in 2022.

2023 年全年，公認會計準則營運費用為 1.65 億美元，而 2022 年為 9,860 萬美元。

Excluding stock based compensation of $15.8 million and depreciation and amortization of $4.3 million, cash operating expenses for the full year of 2023 were approximately $145 million.

不包括 1,580 萬美元的股票薪酬以及 430 萬美元的折舊和攤銷，2023 年全年現金營運支出約為 1.45 億美元。

The increase in year-over-year operating expenses for both the fourth quarter and full year is primarily attributable to launch related costs, higher compensation costs related to increased headcount, and legal costs.

第四季和全年營運費用較去年同期增加的主要原因是推出相關成本、與員工人數增加相關的補償成本增加以及法律費用。

These were offset by lower R&D costs.

這些都被較低的研發成本所抵銷。

Prior to FDA approval on May 1, 2023, inventory expenses -- inventory purchases were expensed as R&D.

在 FDA 於 2023 年 5 月 1 日批准之前，庫存費用——庫存採購被計為研發費用。

With respect to the balance sheet, as of December 31, we had $105 million of cash, cash equivalents, and marketable securities, compared to $153 million at September 30, 2023.

就資產負債表而言，截至12 月31 日，我們擁有1.05 億美元的現金、現金等價物和有價證券，而截至2023 年9 月30 日，我們的現金、現金等價物和有價證券為1.53 億美元。

The $48 million decrease in cash during the fourth quarter is primarily due to net cash used in operations of $26 million, which is net of cash received from sales of LUMRYZ, and $22 million to pay off the remainder of the convertible notes.

第四季現金減少 4,800 萬美元，主要是由於營運中使用的淨現金為 2,600 萬美元，其中扣除了出售 LUMRYZ 收到的現金，以及用於償還剩餘可轉換票據的 2,200 萬美元。

As a result of paying off the notes, we are now effectively debt free.

由於還清了票據，我們現在實際上已經沒有債務了。

During 2024, we currently expect that cash operating expenses before consideration of cash receipts from sales of LUMRYZ will be in the range of $40 million to $45 million per quarter.

2024 年期間，我們目前預計，在考慮 LUMRYZ 銷售現金收入之前的現金營運支出將在每季 4,000 萬至 4,500 萬美元之間。

We believe that net cash used for operations will be materially lower after taking into account expected cash receipts from continuing sales of LUMRYZ.

我們認為，考慮到持續銷售 LUMRYZ 的預期現金收入後，用於營運的淨現金將大幅減少。

As we look ahead based on current trends, plans, and assumptions, we believe we can achieve operating breakeven when there are approximately 1,300 to 1,500 commercially reimbursed patients on therapy and that we can achieve this during 2024.

當我們根據當前趨勢、計劃和假設展望未來時，我們相信，當大約有 1,300 至 1,500 名商業報銷患者接受治療時，我們可以實現營運盈虧平衡，並且我們可以在 2024 年實現這一目標。

In addition to the number of reimbursed patients on therapy, our expectations regarding breakeven take into account a number of other assumptions, including how quickly patient demand grows, net pricing of LUMRYZ, and operating expenses to support the launch of LUMRYZ.

除了接受治療的報銷患者數量之外，我們對盈虧平衡的預期還考慮了許多其他假設，包括患者需求增長的速度、LUMRYZ 的淨定價以及支持 LUMRYZ 上市的營運費用。

Now, I'll wrap up with some commentary regarding 2024 revenue.

現在，我將以一些有關 2024 年收入的評論作為結束語。

While we are not providing formal guidance at this point, we pay close attention to the sell-side estimates.

雖然我們目前沒有提供正式指導，但我們密切關注賣方的估計。

And at this time, we are comfortable with the current consensus of approximately $155 million for the full year, including the possibility the 2024 revenue could be higher if actual results for LUMRYZ, such as, the rate of increase in commercially reimbursed patients, the total number of reimbursed patients who are treated with LUMRYZ, and net pricing outperform the assumptions currently used by the sell-side.

目前，我們對全年約 1.55 億美元的當前共識感到滿意，包括如果 LUMRYZ 的實際結果（例如商業報銷患者的增長率、總收入），2024 年收入可能會更高。 ，淨定價優於賣方目前使用的假設。

And, with that, I will turn the call back to Greg for closing remarks.

然後，我將把電話轉回給格雷格，讓他發表結束語。

Thank you, Tom.

謝謝你，湯姆。

With the strong foundation our team has built and the tenacity in bringing LUMRYZ to the narcolepsy community, we are pleased to see the momentum we created last year has continued as we've entered 2024.

憑藉我們團隊所建立的堅實基礎以及將 LUMRYZ 引入嗜睡症社區的毅力，我們很高興看到我們去年創造的勢頭在進入 2024 年時仍在繼續。

Our 2024 priorities are clear and we remain intently focused on our launch execution, while bridging to cash flow breakeven and the near-term expansion opportunities for Avadel with our lifecycle management strategy.

我們 2024 年的優先事項很明確，我們仍然專注於我們的發布執行，同時透過我們的生命週期管理策略為 Avadel 實現現金流收支平衡和近期擴張機會。

We thank you for your support.

我們感謝你的支持。

We look forward to providing future updates on our progress.

我們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.

接下來，我們將開始提問。

Operator?

操作員？

(Operator Instructions) François Brisebois, Oppenheimer.

（操作員指令）François Brisebois，Oppenheimer。

All right.

好的。

Thanks for taking the question.

感謝您提出問題。

Richard, I think you mentioned over 70% of the top 500 prescribers, I think, represent like 50% of the Scripps here have prescribed LUMRYZ already.

Richard，我想您提到了前 500 名處方醫生中超過 70% 的人，我想，代表了這裡 50% 的斯克里普斯人已經開了 LUMRYZ 處方。

Do you give any granularity as to if they're repeat prescribers, if they've done it with multiple patients?

您是否會詳細說明他們是否重複開藥，是否對多名患者開過藥？

Is there a percentage of that, or is there kind of a feel of a bullish start?

是否有一定比例，或者是否有一種看漲開局的感覺？

Any color there would be helpful.

任何顏色都會有幫助。

Yeah.

是的。

Hey, Frank, good morning.

嘿，弗蘭克，早安。

Thanks for the question.

謝謝你的提問。

Yeah.

是的。

I think, overall, if we think about those top 500, they are the largest volume oxybate prescribers.

我認為，總的來說，如果我們考慮一下前 500 家，他們是最大的羥丁處方者。

We're very pleased to sort of see the penetration that we've had and the majority of those folks have been repeat writers as well.

我們很高興看到我們所擁有的滲透力，而且其中大多數人也是重複作家。

Now, some of them have adopted at different times along the journey here, but we have, like I said, broken over 70% within the vast majority of those being repeat writers at this time as well.

現在，他們中的一些人在這段旅程的不同時期已經採用了，但正如我所說，我們此時也已經突破了絕大多數重複作家中的 70% 以上。

Okay, great.

好的，太好了。

And then in terms of the -- I don't know -- does reimbursement have an impact here on how quickly someone gets the product in their -- patient gets the product in hand?

然後，我不知道，報銷是否會影響患者獲得產品的速度？

Is that evolving with time?

這是隨著時間的推移而發展的嗎？

Or any color there at all would be helpful.

或任何顏色都會有幫助。

Thank you.

謝謝。

Yeah.

是的。

Hi.

你好。

Greg, you want me to take that one?

格雷格，你想讓我拿那個嗎？

Yeah.

是的。

Go ahead, Richard.

繼續吧，理查德。

Yeah, sure.

好，當然。

Thanks again, François.

再次感謝，弗朗索瓦。

So yeah, as far as reimbursement is concerned, yeah.

所以，就報銷而言，是的。

It does matter clearly for us.

這對我們來說確實很重要。

What we generally see is, if patients are covered and they meet the prior authorization criteria, if not on a -- we sort of had given guidelines around about a month, but it's definitely been creeping under a month if you have coverage and you meet the PA criteria.

我們通常看到的是，如果患者得到承保並且他們符合事先授權標準，如果不是——我們已經給出了大約一個月左右的指導方針，但如果你有承保並且滿足了條件，那麼這肯定是在不到一個月的時間內進行的。

So that coverage does matter for us quite a bit here.

因此，報道對我們來說確實很重要。

And we're seeing more of those patients now going through under that period where they do actually have coverage and they meet the criteria.

我們看到更多的患者現在正在經歷這個時期，他們實際上有保險並且符合標準。

So those patients are now going through in well under a month period of time.

因此，這些患者現在正在經歷不到一個月的時間。

Okay, great.

好的，太好了。

Thank you, and congrats on the quarter, guys.

謝謝你們，恭喜這個季度，夥伴們。

Thanks, Franç.

謝謝，弗蘭科。

Ami Fadia, Needham.

阿米法迪亞，尼達姆。

Hi.

你好。

Good morning.

早安.

Thanks for taking my question, and congrats on all the progress that you've made.

感謝您提出我的問題，並祝賀您所取得的所有進展。

Maybe two questions from me.

也許我有兩個問題。

Firstly, just with regards to Anthem.

首先，就《聖歌》而言。

What percent of the Zinc GPO volume is Anthem?

Anthem 佔鋅 GPO 總量的百分之多少？

And maybe for United, what percent of MSR would that comprise?

也許對於曼聯來說，這將佔 MSR 的百分之多少？

And maybe if you could sort of also comment on just general progress in terms of pull through at the individual formerly level across the three different GPOs, that would be helpful to understand.

也許如果您也可以評論一下三個不同 GPO 在個人先前層級的整體進展，這將有助於理解。

And maybe, my second question is, what are you doing to continue to drive this growth at the top of the funnel in terms of adding more patients to RYZUP?

也許，我的第二個問題是，在為 RYZUP 添加更多患者方面，您正在採取哪些措施來繼續推動漏斗頂部的成長？

And what are some of the objectives for 2024 with that regard?

2024 年這方面的目標是什麼？

Thank you.

謝謝。

Richard, do you want to take those?

理查德，你想拿走那些嗎？

Yeah, sure.

好，當然。

Thanks, Ami, for the questions.

謝謝阿米的提問。

Yeah.

是的。

So yeah, first, we're super excited that we have those coverage decisions with both Anthem, United Healthcare, to your point, pushing us over 80% commercially covered lives.

所以，是的，首先，我們非常興奮我們與 Anthem、United Healthcare 都做出了這些承保決定，正如您所說，這使我們的生命覆蓋率超過 80%。

Anthem and UHC are both pretty big for their respective GPOs.

Anthem 和 UHC 對於各自的 GPO 來說都相當大。

Anthem, probably in the neighborhood about 30% of the lives, and United Healthcare probably about similar for the MSR lives as well.

Anthem 可能佔據了附近 30% 的生命，United Healthcare 可能也有類似的 MSR 生命。

So pretty significant large plans where we now have that coverage as well.

這是非常重要的大型計劃，我們現在也有這樣的覆蓋範圍。

As far as the pull through is concerned, as per the previous question, we're definitely seeing now where there is a covered live and patients meet the prior authorization criteria, which is similar to most other oxybates; that those lives are being pulled through, those prescriptions are being pulled through quicker now as well, so the coverage does matter for us.

就拉通而言，根據上一個問題，我們現在肯定會看到哪裡有覆蓋現場並且患者符合事先授權標準，這與大多數其他羥丁酸類似；這些生命正在被渡過，這些處方現在也正在更快地渡過，所以覆蓋範圍對我們來說確實很重要。

And we're seeing that pull through starting to increase our overall conversion rate across the team here as well.

我們看到這種轉變也開始提高我們整個團隊的整體轉換率。

Now to your last question as far as growth drivers for demand, we see several still when it comes to the HCPs.

現在，關於需求成長驅動因素的最後一個問題，我們認為在 HCP 方面仍有一些成長驅動因素。

As we talked about before, there are HCPs who adopt at various stages along the adoption curve.

正如我們之前談到的，有些 HCP 會在採用曲線的不同階段進行採用。

We began our speaker programs to have peer-to-peer education going on for those physicians going forward from the fourth quarter of last year.

從去年第四季開始，我們開始了演講者計劃，為這些醫生提供同儕教育。

I also just announced earlier that our larger patient initiatives will begin the next few weeks through our brand ambassadors for LUMRYZ, where they will share their stories about what LUMRYZ has done for them.

我之前剛剛宣布，我們的更大的患者計劃將在接下來的幾週內通過我們的 LUMRYZ 品牌大使開始，他們將在那裡分享 LUMRYZ 為他們所做的事情的故事。

And we plan to get those out through various forms of media as well.

我們也計劃透過各種形式的媒體將這些內容傳播出去。

So it's really a two-pronged approach, which is to continue our efforts against the HCPs, and to also elevate the voice within the patient community as well.

因此，這其實是雙管齊下的方法，一是繼續努力打擊 HCP，二是提高病患社群內的發言權。

Got it.

知道了。

Thank you.

謝謝。

Andrew Tsai, Jefferies.

安德魯·蔡，杰弗里斯。

Hey, good morning.

嗨，早安。

Congrats on the strong execution, and thanks for taking our questions.

恭喜您的出色執行力，並感謝您提出我們的問題。

So the first one is around conversion rates and discontinuation rates. 2,200 patients have cumulatively signed up.

第一個是關於轉換率和中止率。累計已有2,200名患者報名。

It's a great number.

這是一個很大的數字。

You've confirmed break even for this year.

您已確認今年收支平衡。

So is it still fair to assume that most or the large majority of these sign-ups are bound to convert, suggesting discontinuation rates should still remain very favorable, maybe directionally well below 25%?

那麼，假設大多數或絕大多數註冊用戶必然會發生轉化，這表明終止率仍然非常有利，可能遠低於 25%，這是否仍然公平？

And secondly, you're on a great trajectory with the strong monthly adds, the healthy conversion rates.

其次，您正處於良好的發展軌道上，月度成長強勁，轉換率健康。

Again, you're blasting 2024 sell-side consensus numbers.

再次，你在猛烈抨擊 2024 年賣方共識數字。

So obviously, the trajectory cannot last forever.

顯然，這個軌跡不可能永遠持續下去。

So when should the Street start to consider or model a change in the slope?

那麼街道什麼時候該開始考慮或模擬坡度的變化呢？

Thank you.

謝謝。

Richard, do you want to maybe take the first, the conversion, and discontinuation rates?

理查德，您想了解第一個，即轉換率和停藥率嗎？

Sure.

當然。

I'll take those, and thanks for the questions, Andrew.

我會接受這些，謝謝你的提問，安德魯。

Yeah.

是的。

So yeah, we're very pleased with what the team has been doing through RYZUP and our field reimbursement team for conversion.

所以，是的，我們對團隊透過 RYZUP 和我們的現場報銷團隊進行轉換所做的工作感到非常滿意。

We are seeing our overall conversion rate start to increase over time here as well, so -- and we're seeing both an improvement in the time, especially with patients who are covered with -- who meet the PA criteria.

我們看到我們的整體轉換率也隨著時間的推移開始增加，因此，我們看到時間上都有所改善，特別是對於符合 PA 標準的患者。

But at the same time, we're not giving up on some of the enrollments that have been in our system for a longer period of time; sometimes, they just require a little bit more work.

但同時，我們並沒有放棄一些已經在我們系統中存在較長時間的註冊；有時，他們只是需要多做一點工作。

But along with that, to your point, our discontinuation rate is below what we've seen historically for the twice nightly oxybates.

但除此之外，就您而言，我們的停藥率低於歷史上每晚兩次羥丁藥物的停藥率。

I think you had referenced 25%, which is about the benchmark of discontinuation for twice nightly is at one month.

我想你提到了25%，這大約是一個月停藥兩次的基準。

So we are seeing our rate of discontinuation rates below the historical twice nightly claims historically.

因此，我們看到我們的停藥率低於歷史上每晚兩次的索賠率。

So to your point, we see a nice build up getting more new patients on, and clearly we have a lot of efforts to appropriately keep patients on persistently over time as well.

因此，就您的觀點而言，我們看到了吸引更多新患者的良好進展，而且顯然我們也付出了很多努力來適當地讓患者隨著時間的推移持續不斷地繼續使用。

Greg, I'll maybe pass a last question over back to you.

格雷格，我也許會把最後一個問題轉回給你。

Yes.

是的。

Just a couple of comments.

只是幾點評論。

First, I think, as it relates to conversions and discontinuation rates, I think, with two full quarters into the launch, I think we've done incredibly well in both conversion to initiating on therapy and how we've effectively managed the discontinuation rates through all of our programs and services.

首先，我認為，由於它與轉換率和停藥率有關，我認為，在推出後的兩個完整季度中，我認為我們在轉化為開始治療以及我們如何有效管理停藥率方面都做得非常好透過我們所有的計劃和服務。

So, Richard's right.

所以，理查德是對的。

We're really pleased where we sit, and certainly, we believe are beating the benchmark relative to the existing therapies in the marketplace.

我們真的很高興我們所處的位置，當然，我們相信我們正在超越市場上現有療法的基準。

As it relates to your comment about when should we guide the Street to change an expectation around the slope of the curve right from that standpoint, listen, we're not going to guide specifically around that, Andrew.

因為這與您關於我們何時應該從這個角度指導華爾街改變曲線斜率的預期的評論有關，聽著，我們不會專門圍繞這一點進行指導，安德魯。

I appreciate the question, but I'll just remind everyone that, like, there is a large number of patients who have -- who are in our oxybate market opportunity.

我很欣賞這個問題，但我只是提醒大家，有大量患者擁有我們的羥丁酸市場機會。

That's upwards of 50,000 potential patients when you take in the currently existing treated patients across all forms of twice nightly oxybates, previously discontinued and new starts.

如果您將目前接受過各種形式的每晚兩次羥丁治療的患者（之前已停止的和新開始的）接受治療的患者納入其中，那麼就有超過 50,000 名潛在患者。

We certainly expect to see us to continue to drive demand from all sources of those patients at this point in time.

我們當然希望看到我們此時繼續推動所有患者來源的需求。

So there's a large pie out there.

所以那裡有一個大餡餅。

And our view is that we haven't hit the flattening of our slope at this point.

我們的觀點是，目前我們的斜率尚未趨於平坦。

Great.

偉大的。

Thanks, again, and looking forward to seeing more good news.

再次感謝，並期待看到更多好消息。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Hey, thanks.

嘿，謝謝。

So on the pediatric opportunity, can you talk about realistically how many patients you could capture or percentage of the market you think you can capture with a once-nightly modality?

那麼，關於兒科機會，您能否實際談談您可以透過每晚一次的方式捕獲多少患者或您認為可以捕獲的市場百分比？

So that's number one.

所以這是第一。

And then in IH, how are you thinking about that opportunity in terms of your ability to either expand the market?

那麼在 IH 中，您如何看待這個機會，以及您擴展市場的能力？

Or do you think you get a lot of capture from patients who are on the low-sodium twice nightly oxybate product?

或者您認為您從每晚兩次服用低鈉羥丁產品的患者身上獲得了很多收穫？

Just how you're thinking about those commercial dynamics in IH.

您是如何看待 IH 中的商業動態的。

Thank you.

謝謝。

Yes.

是的。

Thanks, David.

謝謝，大衛。

On pediatrics, depending upon your data source, there's different -- if you will, claims data sources, it would tell us that the actual oxybate utilization of pediatric patients relative to the total pie is anywhere from 3% to 5%.

在兒科方面，根據您的資料來源，情況有所不同——資料來源聲稱，如果您願意的話，它會告訴我們，兒科患者的實際羥丁利用率相對於總數據在3% 到5% 之間。

So it's a relatively small patient population in the context of the full pie.

因此，就整個市場而言，患者群體相對較小。

And part of that is because although onset of symptoms occurs between the ages, normally between the ages of 7 and 17, the diagnosis -- actually the proper diagnosis, doesn't occur to somewhere between 8 to 15 years later, which is something that certainly everyone hopes improves over time.

部分原因是，雖然症狀發作發生在不同年齡之間，通常是在7 歲到17 歲之間，但診斷（實際上是正確的診斷）不會出現在8 到15 年後的某個地方，這是當然，每個人都希望隨著時間的推移有所改善。

So from us, it really has been -- it's much less about the total patient population that are pediatrics who are being treated and much more about really meeting the needs of that patient population and their families, right?

所以對我們來說，它確實是——它不是關於正在接受治療的兒科患者總數，而是更多地關於真正滿足該患者群體及其家人的需求，對嗎？

We've heard extensively from them about how disruptive waking up in the middle of the night is for parents, for the children, and for their families.

我們從他們那裡聽到很多關於半夜醒來對父母、孩子和他們的家人來說有多大的破壞性的事情。

And so, for us, it's a really straightforward opportunity for us to advance to this patient segment and seek approval for it.

因此，對我們來說，這是一個非常直接的機會，讓我們進入這個患者細分市場並尋求批准。

Again, so we do think there's an opportunity to potentially expand that treated patient pool at this stage.

同樣，我們確實認為現階段有機會擴大接受治療的患者群。

But it's much more about just serving a community within the total narcolepsy patient community who really is looking for the opportunity to not wake up.

但這更多的是為了服務整個發作性睡病患者社區中的一個社區，他們真正在尋找不醒來的機會。

With regards to IH, again with over 30,000 uniquely diagnosed patients, and an upwards of another greater than 10,000 to 12,000 patients who we would describe as diagnosed with IH and narcolepsy and then you look at -- there's only one FDA approved drug, and you look at the penetration in that diagnosed patient population at under 10%, we think there is a significant opportunity in IH to help more patients that are being treated.

關於IH，同樣有超過30,000 名獨特診斷的患者，以及超過10,000 至12,000 名以上的患者，我們將其描述為診斷為IH 和發作性睡病，然後你看——只有一種FDA 批准的藥物，而你看看診斷患者群體中低於 10% 的滲透率，我們認為 IH 有很大機會幫助更多正在接受治療的患者。

And again, when we hear from key opinion leaders and physicians at large, the first two things we hear from them after we talk about LUMRYZ and narcolepsy is when are you going to get pediatrics and when are you going to get IH -- when are you going to study in IH?

再說一遍，當我們聽到關鍵意見領袖和廣大醫生的意見時，在我們談論LUMRYZ 和發作性睡病之後，我們從他們那裡聽到的頭兩件事是，你什麼時候要接受兒科檢查，什麼時候要接受IH－什麼時候你要去IH學習嗎？

And for IH, it really is about the fact that these patients suffer from really deep sleep inertia to the extent where they're sleeping 14-, 15-, 16-plus hours a day, and it's hard for them to wake up, right?

對 IH 來說，這確實是因為這些患者患有真正的深度睡眠慣性，他們每天睡 14、15、16 小時以上，而且他們很難醒來，對吧？

It's hard for them to wake up.

他們很難醒來。

And the opportunity to not be forced to do that in the middle of the night just offers a value proposition that is -- that I would say the community is very interested in with LUMRYZ.

不必在半夜被迫這樣做的機會正好提供了一個價值主張，我想說社區對 LUMRYZ 非常感興趣。

So we're excited to initiate that study and update everyone on as we progress it and try to help those patients as well.

因此，我們很高興能夠啟動這項研究，並隨著研究的進展向每個人通報最新情況，並盡力幫助這些患者。

And we think it's another meaningful upside for the long term value of LUMRYZ, for sure.

我們認為這對 LUMRYZ 的長期價值來說無疑是另一個有意義的好處。

Okay.

好的。

Thanks, Greg.

謝謝，格雷格。

Thanks, David.

謝謝，大衛。

Ash Verma, UBS.

阿什‧維爾瑪，瑞銀集團。

Thanks.

謝謝。

Good morning.

早安.

Congrats from my side as well.

我這邊也表示祝賀。

So I have two questions.

所以我有兩個問題。

In terms of the switch patients, can you provide some color on how much of the use is coming from Xyrem versus Xywav?

就轉換患者而言，您能否提供一些關於 Xyrem 與 Xywav 的使用比例的資訊？

A lot of us were surprised to see that Xywav narcolepsy patients are starting to flatten out in the most recent quarter.

我們許多人都驚訝地發現 Xywav 發作性睡病患者在最近一個季度開始趨於平穩。

And then secondly, if you can briefly mention if you're seeing any off-label use on the IH side?

其次，您能否簡單提及您是否發現 IH 方面有任何超說明書使用情況？

Thanks.

謝謝。

Richard, do you want to

理查德，你想嗎

--?

——？

Yeah, no problem.

是的，沒問題。

Thanks for the questions, Ash.

謝謝你的提問，阿什。

So yeah, as far as switch patients are concerned, we do see more coming from the mixed salts, or Xywav than we do from the twice nightly sodium oxybate segments overall as well.

所以，是的，就轉換患者而言，我們確實看到混合鹽或 Xywav 的影響比每晚兩次羥丁酸鈉片段帶來的影響還要多。

Just a couple perspectives here.

這裡只是幾個觀點。

When we did market research early on in the mixed salts launch, we saw that a lot of patients there tended to be earlier adopters of newer therapies.

當我們在混合鹽推出初期進行市場研究時，我們發現那裡的許多患者往往是較早採用新療法的人。

And maybe we're seeing some of this here as well.

也許我們在這裡也看到了一些這樣的情況。

There are some -- there are more patients in the marketplace on the mixed salts version right now as well.

現在市面上也有更多的患者服用混合鹽版本。

But, fundamentally, what we also hear is the amount of wet salts that are associated with the GHB really had no impact on the narcolepsy outcome.

但從根本上說，我們也了解到，與 GHB 相關的濕鹽的量確實對發作性睡病的結果沒有影響。

So it's really not much surprise to us that we're seeing more patients switching from the mixed salts version than the twice nightly sodium oxybate versions as well.

因此，我們看到更多的患者從混合鹽版本轉而使用每晚兩次的羥丁酸鈉版本，這對我們來說並不奇怪。

And to answer your question about off-label usage, clearly, first and foremost, we don't promote any off-label usage, but we have seen requests for off-label usage for both pediatrics and for IH patients as well.

為了回答您關於標籤外使用的問題，首先明確的是，我們不提倡任何標籤外使用，但我們也看到了兒科和 IH 患者的標籤外使用請求。

Thank you.

謝謝。

Thanks, Ash.

謝謝，阿什。

Myriam Belghiti, LifeSci Capital.

Myriam Belghiti，生命科學資本。

Thank you.

謝謝。

Good morning.

早安.

Just a quick question for me.

只是問我一個簡單的問題。

Can you comment on patient type signing up to the RYZUP program and if you see any differentiation than those that ultimately receive therapy?

您能否評論一下註冊 RYZUP 計劃的患者類型以及您是否發現與最終接受治療的患者有什麼區別？

Is it a similar process for naive patients, discontinued patients, and such patients going through the RYZUP program?

對於初次接受治療的患者、已停藥的患者以及正在接受 RYZUP 計劃的此類患者來說，是否有類似的過程？

Richard, do you want to take that?

理查德，你想接受這個嗎？

Yes.

是的。

Sure.

當然。

Thanks, Myriam.

謝謝，米里亞姆。

So, yes.

所以，是的。

Yes, the process is quite similar, because the way I describe the RYZUP enrollment, it's almost like a prescription.

是的，這個過程非常相似，因為我描述 RYZUP 註冊的方式幾乎就像處方一樣。

And the only reason it isn't is because we have the three different specialty pharmacies within our network.

唯一的原因是，我們的網路內有三個不同的專業藥局。

So the process is generally initiated by the provider.

所以這個過程一般是由提供者發起的。

And the amount of information that's required, depending on what type of patient you are is generally the same if you are a switch, with the exception of a box which indicates if you had former usage of an oxybate.

如果您是轉換患者，則所需的資訊量通常是相同的，具體取決於您的患者類型，但有一個方框表明您以前是否使用過羥丁酸鹽。

So yeah, we seem to be generally consistent across the board there as well.

所以，是的，我們在這方面似乎也總體上是一致的。

And we're clearly very pleased to sort of see strong demand coming in through RYZUP as well.

我們顯然非常高興看到 RYZUP 也帶來了強勁的需求。

Okay, got it.

好，知道了。

And then you spoke of a KOL-led speaker program today.

然後您今天談到了由 KOL 主導的演講者計劃。

Can you provide a bit more detail on what that entails?

您能否提供更多關於這需要什麼的細節？

Yeah.

是的。

We -- one of the things that's very important -- if you think about it beyond the terrific work that our medical team has done with publications and presentations at scientific medical congresses, it's pretty much been our voice carrying the word for LUMRYZ.

我們——這是非常重要的事情之一——如果你考慮一下我們的醫療團隊在科學醫學大會上發表出版物和演講方面所做的出色工作，那麼幾乎就是我們的聲音在傳達 LUMRYZ 的聲音。

So we now have a speaker bureau, we have trained experts in narcolepsy across the country who are now doing speaker programs on our behalf.

所以我們現在有了一個演講局，我們在全國範圍內培訓了嗜睡症專家，他們現在正在代表我們開展演講計畫。

We're generally speaking to other super providers and some of their colleagues within their offices and it's been really great to see.

我們通常會與其他超級提供者及其辦公室內的一些同事進行交談，看到這一點真的很高興。

We did quite a few of these programs as we exited Q4 of last year.

去年第四季結束時，我們做了很多這樣的計畫。

We have executed many more of those programs in Q1 of this year.

今年第一季度，我們執行了更多此類計劃。

And we're also doing things such as like national programs as broadcast programs as well.

我們也在做諸如將國家節目作為廣播節目之類的事情。

So it's really a great opportunity to get a fair and balanced perspective out on LUMRYZ and the narcolepsy marketplace.

因此，這確實是一個獲得公平、平衡的視角來了解 LUMRYZ 和嗜睡症市場的絕佳機會。

And the reception and the turnout has been really positive to see that many sort of sleep specialists that have come out to these programs.

看到許多類型的睡眠專家參與這些項目，接待和投票率非常積極。

So getting that peer-to-peer education out for HCPs we think is quite critical.

因此，我們認為為 HCP 提供同儕教育非常重要。

And these speaker programs are a very important tactic for us to execute that.

這些演講者計畫是我們執行這一目標的一個非常重要的策略。

Okay.

好的。

Got it.

知道了。

Congrats again on the great year.

再次恭喜偉大的一年。

Thank you.

謝謝。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning, guys.

早上好傢伙。

Yeah.

是的。

Great update.

很棒的更新。

Share my congrats as well.

也分享我的祝賀。

So, I just want to maybe better characterize those patients that sit in the RYZUP program for longer.

因此，我只是想更好地描述那些參加 RYZUP 計劃時間較長的患者。

In some instances, it looks like much longer than the one month average you kind of mentioned.

在某些情況下，它看起來比您提到的一個月平均值要長得多。

So just generally, what are the characteristics of these patients that sit on the program?

那麼一般來說，參與該計劃的這些患者有哪些特徵？

And do they not just meet the -- do they just not meet the PA criteria?

難道他們只是滿足——他們只是不符合 PA 標準嗎？

And then should we still think of conversion rate there reaching very high numbers, or some of these patients just going to sit on the program?

那麼我們是否仍然應該考慮那裡的轉換率達到非常高的數字，或者其中一些患者只是繼續參加該計劃？

Thanks.

謝謝。

Richard, do you want to take that?

理查德，你想接受這個嗎？

Yeah, sure.

好，當然。

Thanks, Chase.

謝謝，蔡斯。

Yeah.

是的。

So it's a great observation as far as some of these patients who have been in the process for longer.

因此，對於一些已經在這個過程中待了更長時間的患者來說，這是一個很好的觀察。

To your point, the general characterization is -- they may not have met the prior authorization criteria, or in some cases, they weren't covered live.

就您的觀點而言，一般特徵是——它們可能不符合事先授權標準，或者在某些情況下，它們沒有被即時覆蓋。

What we've seen with the process is then it's a medical necessity or it's going through an appeal and a denial process.

我們在這個過程中看到的是，它是醫療必需品，或者它正在經歷上訴和拒絕過程。

Now, one of the things we're very proud of and what we built with our RYZUP team as well is the tenacity of the team there to not give up on these cases.

現在，我們非常自豪的事情之一以及我們與 RYZUP 團隊一起建立的東西是團隊不放棄這些案例的堅韌。

So while on one hand we're very focused on faster turnaround time, especially for patients who meet all the criteria, to your point, we're also not giving up on these longer standing cases.

因此，雖然一方面我們非常注重更快的周轉時間，特別是對於符合所有標準的患者，但就您的觀點而言，我們也不會放棄這些長期存在的病例。

And generally, what we have seen is a pretty good success rate oftentimes after many rounds of appeals and denials going through where we still can get a large portion of these patients initiated onto reimbursed therapy as well.

一般來說，我們看到的是，經過多輪上訴和拒絕後，我們仍然可以讓大部分患者開始接受報銷治療，成功率相當高。

So to that point where we see sometimes enrollments that started back six months ago who can ultimately get onto therapy as well.

因此，我們有時會看到六個月前開始的註冊，最終也可以接受治療。

So it's still relatively early for us to figure out what those success rates should look like.

因此，我們現在要弄清楚這些成功率應該是什麼樣子還為時過早。

But we are still seeing on a monthly basis, what we would call more aged RYZUP cases, who are successfully able to get the therapy sometime several months later.

但我們仍然每月都會看到更多老年 RYZUP 病例，他們在幾個月後的某個時候成功獲得了治療。

Thanks, Makes sense, Richard.

謝謝，有道理，理查。

Thank you.

謝謝。

All right.

好的。

No problem.

沒問題。

Thanks, Chase.

謝謝，蔡斯。

Marc Goodman, Leerink.

馬克‧古德曼，萊林克。

Thanks for taking my question.

感謝您提出我的問題。

This is Rudy on the line for Marc.

我是魯迪，正在接聽馬克的電話。

Congrats on the strong results.

祝賀取得強勁的成果。

So I have question regarding the market dynamics.

所以我對市場動態有疑問。

Do you see the total oxy market continue to expand in the coming years?

您認為未來幾年整個氧氣市場會繼續擴大嗎？

I'm also curious about your thoughts on the opportunity of the oxy products.

我也很好奇您對含氧產品機會的看法。

And do you see any potential impact in the oxybate in NT1 versus NT2 and IH?

您認為 NT1 與 NT2 和 IH 中的羥丁酸鹽有任何潛在影響嗎？

Thanks.

謝謝。

Thanks, Rudy.

謝謝，魯迪。

Richard, do you want to take that as well?

理查德，你也想接受嗎？

Yeah.

是的。

No.

不。

Thanks, Rudy.

謝謝，魯迪。

Yeah.

是的。

So as far as the market dynamics is concerned, yeah, prior to launch, we had done six different quant market research studies.

就市場動態而言，是的，在發布之前，我們已經完成了六項不同的定量市場研究。

That really showed with the introduction of LUMRYZ that the oxybate market could expand with the new patient, starts somewhere in the neighborhood of 30% to 50%.

隨著 LUMRYZ 的推出，這確實表明羥丁酸鹽市場可以隨著新患者的增加而擴大，從 30% 到 50% 左右開始。

It's hard for us to say right now, because some of the other data from other companies is no longer as visible as it used to be.

我們現在很難說，因為其他公司的一些其他數據不再像以前那樣可見。

So what we're definitely seeing right now is a few things.

所以我們現在肯定會看到一些事情。

One is we're getting more people who had never prescribed an oxybate previously into the mix who prescribed.

一是我們正在讓更多以前從未開過羥丁酸鹽處方的人加入處方中。

And we're seeing obviously strong penetration within existing oxybate prescribers.

我們看到現有的羥丁酸鹽處方者明顯具有強烈的滲透力。

So we definitely believe we're seeing some of the dynamics of patients going beyond using LUMRYZ, where they maybe were more limited with twice on the oxybates.

因此，我們絕對相信，我們看到患者的一些動態超出了使用 LUMRYZ 的範圍，他們可能在使用兩次羥丁酸鹽時受到更多限制。

And as far as I think your question around orexins are concerned, for us, we're very excited to see any new treatment modalities that could potentially come to the marketplace.

就我認為您關於食慾素的問題而言，對我們來說，我們非常高興看到任何可能進入市場的新療法。

Obviously, those companies still have to go through the clinical and regulatory process as well.

顯然，這些公司也必須經歷臨床和監管流程。

The first one that we see is focusing more on NT1.

我們看到的第一個更關注 NT1。

I guess, a couple of things that we see when it comes to orexins, they look to be really fabulous weight promoting agents, maybe a little less certain around their impact on sleep.

我想，當談到食慾素時，我們看到了一些事情，它們看起來確實是非常棒的體重促進劑，但它們對睡眠的影響可能不太確定。

And clearly, there's a lot of questions around the overall benefit risk profile between efficacy and tolerability as well.

顯然，療效和耐受性之間的整體獲益風險狀況也存在許多問題。

But the one thing we do know overall is this tends to be a polypharmacy marketplace.

但我們確實知道的一件事是，這往往是一個多藥市場。

It has been in the past, and it likely will be in the future as well.

過去如此，將來也可能如此。

So we believe that LUMRYZ is well positioned not only in NT2, but clearly because of the benefit that it has in NT1 as well.

因此，我們相信 LUMRYZ 不僅在 NT2 中處於有利位置，而且顯然還因為它在 NT1 中也具有優勢。

So I think, we're still early on there as well.

所以我認為，我們還處於早期階段。

But one thing that we always consider, oxybates are used today in about less than 10% of patients who are diagnosed and under care for narcolepsy.

但我們始終考慮的一件事是，目前被診斷並接受治療的發作性睡病患者中約有不到 10% 使用羥丁酸鹽。

So we still see there's lots of room for oxybates to grow, as Greg had mentioned previously.

因此，正如格雷格之前提到的，我們仍然看到含氧酸鹽還有很大的成長空間。

And we believe we're well positioned today and also as new therapies come out in the future as well.

我們相信，我們今天已經處於有利位置，隨著未來新療法的出現，我們也處於有利位置。

Thanks.

謝謝。

Thanks, Rudy.

謝謝，魯迪。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hi, good morning, guys.

嗨，早上好，夥計們。

Thanks for taking the questions.

感謝您提出問題。

I guess, maybe can you provide some more color in terms of what you're hearing with respect to how important the low sodium formulation is in the marketplace right now, and your strategy there as you move forward your formulation?

我想，也許您可以根據您所聽到的關於低鈉配方目前在市場上的重要性以及您在推進配方時的策略提供更多資訊嗎？

Richard, do you want to talk about that?

理查德，你想談談這個嗎？

Yeah, I'll take the first part there, Matt.

是的，我將開始第一部分，馬特。

Thanks.

謝謝。

So yeah, candidly, from our field, we hear a lot less objections about sodium content overall.

所以，是的，坦白說，在我們的領域，我們聽到的關於鈉含量的反對意見總體上要少得多。

I'd say a couple of things.

我想說幾件事。

First, we now have our team out there as well.

首先，我們現在也有了我們的團隊。

Secondarily, one of the key publications that our team uses is a publication that came out in 2020 where sleep experts from Stanford and UCLA looked at the history of twice nightly sodium oxybate.

其次，我們團隊使用的關鍵出版物之一是 2020 年出版的出版物，來自史丹佛大學和加州大學洛杉磯分校的睡眠專家研究了每晚兩次羥丁酸鈉的歷史。

And their conclusion was that there was really no difference in cardiovascular outcomes on patients on twice nightly sodium oxybate products at that time.

他們的結論是，當時每晚服用兩次羥丁酸鈉產品的患者的心血管結果確實沒有差異。

So I think, candidly, what's happened is science is being focused on here, and there's good published data that's able to be used.

所以我認為，坦白說，現在的情況是科學正在被關注，並且有很好的已發表數據可以使用。

And there is another company out there talking about the benefits of what a once bedtime therapy can do overall.

還有另一家公司正在談論一次睡前療法的整體好處。

So we really haven't heard as much of that in the field.

所以我們在這個領域確實沒有聽到那麼多這樣的消息。

There clearly are still some HCPs focusing on that.

顯然仍有一些 HCP 關注這一點。

But I think, now, as patients are -- HCPs are getting experience with LUMRYZ and seeing the benefit of what it can offer to their patients, I think that's held a lot of weight with those offices as well.

但我認為，現在，隨著患者 - HCP 正在獲得 LUMRYZ 的經驗，並看到它可以為患者提供的好處，我認為這些辦公室也很重視這一點。

And I know, Greg, if you want to talk about our lower sodium as well?

我知道，格雷格，您是否也想談談我們的低鈉含量？

Yeah.

是的。

I think, in that regard, Matt, I think our view is that there are patients who have sodium sensitivities or other comorbidities that may require them to accommodate for that in their oxybate treatment choice.

我認為，在這方面，馬特，我認為我們的觀點是，有些患者對鈉敏感或有其他合併症，可能需要他們在羥丁治療選擇中適應這一點。

And we want to make sure all those patients have an opportunity to be on a once at bedtime therapy option.

我們希望確保所有這些患者都有機會接受睡前一次治療。

So that's why we continue to proceed with it.

這就是我們繼續前進的原因。

And from that perspective, we think everyone should have that option.

從這個角度來看，我們認為每個人都應該有這個選擇。

Okay.

好的。

That's helpful.

這很有幫助。

And then a second question.

然後是第二個問題。

In terms of the IH opportunity, you stated that you plan to launch your study second half this year.

關於IH機會，您表示計劃在今年下半年啟動您的研究。

Can you give us more detail in terms of the potential timeline there and of that program?

您能否為我們提供有關該計劃的潛在時間表的更多詳細資訊？

Yeah.

是的。

I think, it's a little bit premature to guide specifically on when we think enrollment will be completed or what not.

我認為，現在就我們認為註冊何時完成或何時完成進行具體指導還為時過早。

We clearly will initiate in the second half of this year and have every incentive to do that as early as we possibly can.

我們顯然將在今年下半年啟動，並有充分的動力儘早這樣做。

There's just a lot of work that has to go in in terms of starting up a trial, and we're well into that now, whether that's CRO selection, or site selection, and feasibility assessments at the site level, clinical supply, placebo manufacturing, all those sorts of things.

在啟動試驗方面還有很多工作要做，我們現在已經著手進行，無論是 CRO 選擇，還是場地選擇，以及場地層面的可行性評估、臨床供應、安慰劑生產，所有這些事情。

So all of that is happening now.

所以這一切現在正在發生。

So we're well on track from that perspective.

所以從這個角度來看，我們已經步入正軌。

And so, we'll cover more.

因此，我們將介紹更多內容。

We'll provide more context as we get into it for sure.

當我們進入這個主題時，我們肯定會提供更多的背景資訊。

But the team has done an excellent job to ramp that up relatively quickly since the back end of last year, and we'll have more to talk about in the near future for sure.

但自去年年底以來，該團隊做得非常出色，相對較快地提高了這一水平，我們肯定會在不久的將來有更多的內容要討論。

Sounds good.

聽起來不錯。

Thanks a lot.

多謝。

Oren Livnat, H.C. Wainwright.

奧倫·利夫納特，H.C.溫賴特。

Thanks.

謝謝。

Congrats on the fast ramp here.

恭喜這裡的快速坡道。

I have a couple.

我有一對。

First, I think, I'm tense in the queue here, and nobody's asked about the elephant in the room, so I will.

首先，我想，我在這裡排隊很緊張，而且沒有人問房間裡的大象，所以我會的。

Can you talk about your statement up front about your confidence in that, whatever the jury decides, presumably any day now, your confidence in the potential of LUMRYZ?

您能否先談談您對 LUMRYZ 潛力的信心，無論陪審團如何決定，大概是現在的任何一天？

Why are you confident about the outcomes?

為什麼您對結果充滿信心？

And what do you think the scenarios could be going forward?

您認為未來的情況會是如何？

And also, do you have any update on timing around the APA lawsuit that are obviously publicly available or whatever color you might have on that front?

另外，您是否有任何關於 APA 訴訟的時間安排方面的最新信息，這些信息顯然是公開的，或者您在這方面可能有什麼顏色？

And then I have a follow up.

然後我有一個後續行動。

Thanks.

謝謝。

So the answer to your first question, Oren, is really easy, which is we're just not going to comment on it at this stage.

所以，奧倫，你的第一個問題的答案非常簡單，就是我們現階段不會對此發表評論。

That will become clear in the fairly near future from that standpoint, pending the jury's final decision.

從這個角度來看，在陪審團做出最終決定之前，這一點將在不久的將來變得清晰。

So I would just ask you to be patient with us on that regard.

因此，我只想請您在這方面對我們保持耐心。

The status of the APA case, I think that hearing has been moved to April 9.

APA案件的現狀，我認為聽證會已經移至4月9日。

So that will take place on April 9 in the court in the District of Columbia.

這將於 4 月 9 日在哥倫比亞特區的法院進行。

So

所以

--

--

Okay.

好的。

And as I try to square your commentary and your ramp with Jazz's guidance, it seems like market growth must be an important variable there.

當我試圖將你的評論和你的成長與爵士樂的指導相結合時，看起來市場成長一定是一個重要的變數。

They say you're not growing the market that much yet.

他們說你的市場還沒發展到那麼大。

I think, you've highlighted certainly that obviously most of your adds are from switchers, which is as expected.

我認為，您肯定已經強調了，顯然您的大部分添加都來自切換器，這正如預期的那樣。

But going forward through 2023 and -- or 2024 and beyond, how confident are you that you can grow the market more and accelerate that growth as your product's been out there longer with regards to bringing back prior discontinuers and whether those patients are identified to you or your customers and new diet patients being added?

但展望 2023 年、或 2024 年及以後，您對如何擴大市場並加速增長有多大信心，因為您的產品已經上市了更長的時間，涉及恢復先前的停藥者以及這些患者是否已被識別或者您的客戶和新的飲食患者正在增加？

Yeah.

是的。

Richard, do you want to start on that?

理查德，你想開始嗎？

Yeah.

是的。

No.

不。

Sure, Oren.

當然，奧倫。

Like I said -- we said before, what we see already right now to your point is the previously discontinued segment is real, and we're seeing good representation of that within our RYZUP numbers and patients being shipped product already.

就像我說的- 我們之前說過，我們現在已經看到的是，之前停產的細分市場是真實存在的，我們在RYZUP 數據中看到了很好的體現，並且已經向患者發貨了產品。

We're getting new prescribers who have never written for an oxybate previous to LUMRYZ being in the marketplace before as well.

我們正在招募新的處方者，他們在 LUMRYZ 上市之前從未寫過羥丁藥物。

And here's the one thing that's also a little bit challenging right now.

現在還有一件事也有點挑戰性。

We've candidly worked hard to sort of keep our data to ourselves.

我們坦誠地努力保密我們的資料。

So when other companies are looking at data from claims, they may not also be seeing the whole picture at this stage as well.

因此，當其他公司查看索賠資料時，他們現階段可能也看不到全貌。

And what we see internally is some strong early signs that people are going beyond where twice nightly oxybates were being used previously -- previous to LUMRYZ being in the marketplace.

我們在內部看到的是一些強烈的早期跡象，表明人們正在超越以前使用每晚兩次羥丁酸的情況——在 LUMRYZ 進入市場之前。

That's helpful.

這很有幫助。

And just one last follow up.

還有最後一次跟進。

Can you comment at all on, I guess, net pricing or gross to nets, I guess, in fourth quarter or annualized in general now going forward?

我想，您能否對第四季度的淨定價或總淨定價或現在的年度化總體情況發表評論？

Tom?

湯姆？

Yes.

是的。

Hi, Oren.

嗨，奧倫。

Yes.

是的。

So we previously have guided to $120,000 net revenue per patient, per year.

因此，我們先前指導每位患者每年的淨收入為 120,000 美元。

And as I've described in the past, we'll get there when we reach a critical mass, which I would define as more patients continuing on therapy than new patients coming on to therapy.

正如我過去所描述的，當我們達到臨界質量時，我們就會到達那裡，我將其定義為繼續接受治療的患者數量多於接受治療的新患者數量。

With that said, I think we're rapidly approaching that point, and looking forward to providing more updates on that in the future.

話雖如此，我認為我們正在迅速接近這一點，並期待在未來提供更多相關更新。

All right.

好的。

Thanks.

謝謝。

Thank you.

謝謝。

I'll follow up with you guys after.

之後我會跟大家跟進的。

I show no further questions at this time.

我目前沒有提出任何進一步的問題。

So this will conclude our Q&A session.

我們的問答環節到此結束。

I would now like to turn the call back to Greg Divis for closing remarks.

現在我想將電話轉回給格雷格·迪維斯，讓其致閉幕詞。

Thank you, and thanks, everyone, for your time for joining us today on our call.

謝謝大家，謝謝大家今天抽出時間參加我們的電話會議。

And we wish you all a great day, and we certainly look forward to providing more updates here in the very near future.

我們祝大家度過愉快的一天，我們當然期待在不久的將來在這裡提供更多更新。

Thanks.

謝謝。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。