Avadel Pharmaceuticals PLC (AVDL) 2024 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Greetings, and welcome to Avadel's Pharmaceuticals business update conference call.

    您好,歡迎參加 Avadel 製藥業務更新電話會議。

  • (Operator Instructions) Accompanying slides for this call can be found on Avadel's Investor Relations website.

    (操作員說明)本次電話會議的附帶投影片可在 Avadel 的投資者關係網站上找到。

  • A question-and-answer session will follow the formal presentation.

    正式演講結束後將進行問答環節。

  • As a reminder, this conference is being recorded.

    提醒一下,本次會議正在錄音。

  • It is now my pleasure to introduce Austin Murtagh with Precision AQ.

    現在我很高興向大家介紹 Precision AQ 的 Austin Murtagh。

  • Thank you.

    謝謝。

  • You may begin.

    你可以開始了。

  • Austin Murtagh - Investor Relations

    Austin Murtagh - Investor Relations

  • Good afternoon, and thank you for joining us on our conference call to discuss Avadel's business update and outlook for 2025.

    下午好,感謝您參加我們的電話會議,討論 Avadel 的業務更新和 2025 年展望。

  • Moving to slide 2.

    移至投影片 2。

  • As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    提醒一下,在我們開始之前,以下介紹包括幾項根據 1995 年私人證券訴訟改革法的安全港條款所作的前瞻性聲明。

  • These statements include, but are not limited to, statements regarding the company's expectations on preliminary commercial metrics, unaudited financial results, forward-looking patient metrics, revenue opportunity and revenue estimates, and the success of the commercialization of LUMRYZ.

    這些聲明包括但不限於有關公司對初步商業指標、未經審計的財務結果、前瞻性患者指標、收入機會和收入估計以及 LUMRYZ 商業化成功的預期的聲明。

  • 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.

    前瞻性陳述受風險和不確定性的影響,這些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, and which was filed on February 29, 2024, and subsequent SEC filings.

    這些風險和不確定性在 Avadel 根據《交易所法》提交的公開文件中有所描述,該文件包括截至 2023 年 12 月 31 日的年度 10-K 表格,該表格於 2024 年 2 月 29 日提交,以及隨後的 SEC 文件中有所描述。

  • The forward-looking statements made today are as of the date of this call.

    今天所做的前瞻性陳述截至本次電話會議當天。

  • And 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。

  • In addition, we may refer to certain non-GAAP measures during this call, and these measures should not be considered in isolation or as alternatives to or substitutes for financial measures determined in accordance with generally accepted accounting principles in the United States.

    此外,我們可能會在本次電話會議中參考某些非公認會計準則指標,這些指標不應單獨考慮或作為根據美國公認會計原則確定的財務指標的替代或替代。

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

    參加今天電話會議的有執行長 Greg Divis;以及財務長湯姆·麥克休(Tom McHugh)。

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

    現在,我將把電話轉給格雷格。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Welcome, everyone, and thank you for joining us today.

    歡迎大家,感謝大家今天的參加。

  • As we're now 18 months into the launch of Luis, we've decided to take a slightly different approach to our January business update and 2025 preannouncement.

    由於 Luis 推出已有 18 個月,我們決定採用略有不同的方式發布 1 月份的業務更新和 2025 年的預告。

  • As such, turning to slide 3.

    因此,轉到投影片 3。

  • Today, we will cover the following topics.

    今天,我們將討論以下主題。

  • We'll provide a limited launch update and review priorities and actions being taken to accelerate the launch.

    我們將提供有限的發布更新,並審查優先事項和為加速發布而採取的行動。

  • We'll review our Q4 and full year 2024 preliminary results and for the first time, provide initial revenue guidance for 2025.

    我們將回顧 2024 年第四季和全年的初步業績,並首次提供 2025 年的初步收入指引。

  • We'll review the progress and a path forward toward achieving the $1 billion potential revenue opportunity for LUMRYZ.

    我們將回顧進展並展望 LUMRYZ 實現 10 億美元潛在收入機會的未來道路。

  • And lastly, provide an update on our life cycle management programs and our 2025 key milestones.

    最後,提供有關我們的生命週期管理計劃和 2025 年關鍵里程碑的最新資訊。

  • Moving to the next slide.

    移至下一張投影片。

  • As a company, we've made tremendous progress over the last few years, building our business and capabilities to enable our transformation of the sleep space for patients, for their families, and their healthcare providers, while overcoming a attempts by our competitor, Jazz, to delay LUMRYZ coming to market.

    作為一家公司,我們在過去幾年中取得了巨大的進步,建立了我們的業務和能力,使我們能夠為患者、患者家屬和醫療保健提供者改變睡眠空間,同時克服了競爭對手 Jazz 推遲 LUMRYZ 上市的企圖。

  • Our progress has been brought to life for me recently with a patient story from Texas.

    最近,來自德州的一位患者的故事讓我深刻感受到我們所取得的進展。

  • A nurse practitioner working in the emergency room was really struggling with the dosing of the first generation mixed salt product.

    急診室的一位執業護理師對於第一代混合鹽產品的劑量感到非常困惑。

  • And as such, in a discussion with her physician, made the decision to switch to LUMRYZ.

    因此,在與她的醫生討論後,她決定改用 LUMRYZ。

  • And according to our sleep specialist, she is functioning better and has also been able to decrease her daily dose of stimulants.

    根據我們的睡眠專家的說法,她的狀況變得更好,並且能夠減少每日服用的興奮劑劑量。

  • Most importantly, she has expressed how happy she is with her now simplified and effective treatment regimen.

    最重要的是,她表達了對現在簡化且有效的治療方案的滿意。

  • This is just one of many examples of the feedback we regularly receive from physicians and patients alike.

    這只是我們經常從醫生和患者那裡收到的眾多回饋中的一個。

  • Based on this feedback, the impact we're having and the progress made to date, we remain confident in our belief that LUMRYZ is a best-in-class therapy for people with narcolepsy and is on its way to market leadership.

    根據這些回饋、我們產生的影響以及迄今為止的進展,我們仍然堅信 LUMRYZ 是治療嗜睡症患者的最佳方法,並且正在走向市場領先地位。

  • Like other rare disease products at this early stage of launch, we are in a critical period of establishing the initial foundation upon which the continued and future success of LUMRYZ will be built.

    與其他處於上市初期的罕見疾病產品一樣,我們正處於奠定初始基礎的關鍵時期,為 LUMRYZ 的持續和未來成功奠定基礎。

  • On slide 5, as we move into 2025 and our foundation continues to strengthen, our LUMRYZ launch priorities are threefold: first, expanding our physician reach and impact across all patient segments; second, accelerating our investments in activating switch patients; and finally, driving improvements in patient persistency. 2025 will be a year of growth and a year where we can and will go further and faster.

    在第 5 張投影片上,隨著我們進入 2025 年並且我們的基礎不斷加強,我們的 LUMRYZ 推出重點有三方面:首先,擴大我們的醫生覆蓋範圍和對所有患者群體的影響力;第二,加速對激活轉換患者的投資;最後,推動患者堅持不懈的改善。 2025年是成長的一年,也是我們能夠走得更遠、更快的一年。

  • So let's review our launch to date results and our key priorities for this year.

    讓我們回顧一下迄今為止的成果以及今年的重點任務。

  • Moving to slide 6.

    移至幻燈片 6。

  • Since launch, we have delivered strong and consistent demand in our initial primary targeted audience, resulting in nearly $200 million in net sales, more than 3,700 patient starts, and greater than 2,500 patients on therapy today.

    自推出以來,我們在最初的主要目標受眾中實現了強勁而持續的需求,帶來了近 2 億美元的淨銷售額、超過 3,700 名患者開始接受治療,以及超過 2,500 名患者正在接受治療。

  • From a patient perspective, we have generated demand from all patient types which was initially led by switch patients at approximately 50% of all patient starts.

    從患者的角度來看,我們已經產生了所有患者類型的需求,其中最初由轉換患者主導,約佔所有患者開始數量的 50%。

  • More recently, on slide 7, we have seen a shift in our patient mix with the rapid growth of new to oxybate patients, who, when combined with previously treated patients, in Q4, represented 62% of all starts.

    最近,在第 7 張投影片上,我們看到患者結構發生了變化,新接受羥基丁酸鹽治療的患者迅速增長,與先前接受過治療的患者相結合,在第四季度,新接受羥基丁酸鹽治療的患者佔所有新接受治療患者的 62%。

  • Importantly, reimbursed patients now represent nearly three-quarters of all patients on therapy.

    重要的是,報銷患者現在佔接受治療的所有患者的近四分之三。

  • As stated on slide 8, these results have been primarily driven by two physician segments.

    如投影片 8 所述,這些結果主要由兩個醫生群體推動。

  • First, we have seen successful limited uptake with a segment of physicians who have become our early adopters, and are core to the foundation we are building.

    首先,我們看到一部分醫生成功地進行了有限的採用,他們已經成為我們的早期採用者,並且是我們正在建立的基礎的核心。

  • This group of less than 500 early adopters have delivered nearly two-thirds of all LUMRYZ patient starts.

    這群不到 500 名早期採用者已經為所有 LUMRYZ 患者提供了近三分之二的治療服務。

  • It only represents one-fourth of the total oxybate market opportunity.

    它僅佔整個氧化物市場機會的四分之一。

  • The second group of physicians are those who have previously never prescribed an oxybate before.

    第二組醫生是以前從未開過羥基丁酸鹽處方的醫生。

  • This group now represent approximately 15% of our patient starts, further validating the emerging market expansion opportunity LUMRYZ offers.

    該群體目前約占我們患者的 15%,進一步驗證了 LUMRYZ 提供的新興市場擴張機會。

  • These early successes are the result of focused commercial execution against important segments of prescribers, which validates that we can generate significant LUMRYZ demand.

    這些早期的成功是針對處方者重要群體進行有針對性的商業執行的結果,這證明我們可以產生巨大的 LUMRYZ 需求。

  • This also demonstrates that we have much more work to do in this highly competitive and concentrated rare disease market.

    這也表明,在這個競爭激烈、集中度極高的罕見疾病市場,我們還有許多工作要做。

  • With the same level of focus and consistent execution during 2025, we believe we will achieve significant results with the remaining 75% of the existing oxybate market, we have not yet materially penetrated.

    透過在 2025 年保持相同的專注度和持續的執行力,我們相信我們將在現有氧化物酸鹽市場剩餘的 75%(我們尚未實質滲透)領域取得顯著成果。

  • This group of underpenetrated prescribers is a key pathway to continued growth, and in particular, switch patient growth, a primary focus for us in 2025.

    這群滲透率不足的處方者是實現持續成長的關鍵途徑,尤其是轉換病患成長,這是我們 2025 年的主要關注點。

  • Based on our ongoing physician and patient market research, which is supported by our promotional response analysis, these physicians are typically slower adopters and require more consistent and improved commercial execution and impact, which is something we have addressed.

    根據我們正在進行的醫生和患者市場研究,該研究得到了我們的促銷反應分析的支持,這些醫生通常採用速度較慢,需要更一致和改進的商業執行和影響力,而這正是我們已經解決的問題。

  • In addition, we are deploying programs and initiatives to unlock future switch patients.

    此外,我們正在部署計劃和舉措,以解鎖未來的轉換患者。

  • This is important as some patients based on research can be concerned about reimburse matters such as out-of-pocket costs or even losing access to oxybate if they consider switching, all of which are being actioned.

    這很重要,因為根據研究,一些患者可能會擔心報銷事宜,例如自付費用,或者如果他們考慮轉換藥物,甚至會失去獲得羥基丁酸鹽的機會,而所有這些都正在採取行動。

  • Turning to slide 9, switch patients are and will remain a critical focus as they typically have an easier path to securing reimbursement and initiating LUMRYZ.

    第 9 頁,轉換患者現在是並且仍將是重點關注對象,因為他們通常有更簡單的途徑獲得報銷和啟動 LUMRYZ。

  • They have proven to have meaningfully higher persistency rates.

    事實證明,它們的持久率明顯更高。

  • And on average, represent a greater revenue opportunity.

    平均而言,代表著更大的收入機會。

  • As such as stated on slide 10, our demand-based priorities for this year are focused on accelerating the growth of patients on therapy, and in particular, switch and reimbursed patients.

    正如幻燈片 10 所述,我們今年基於需求的優先事項是加速接受治療的患者的成長,特別是轉換和報銷患者。

  • We will do this by expanding and upgrading our sales force and deploying tools and tactics to drive greater switch patient focus and impact on this underpenetrated market opportunity.

    我們將透過擴大和升級我們的銷售團隊以及部署工具和策略來做到這一點,以推動更大程度地轉換患者關注並影響這個尚未充分滲透的市場機會。

  • We're increasing our direct to oxybate patient marketing efforts to accelerate oxybate patient education and activation to ask for LUMRYZ, while continuing our pursuit of market leadership in the new-to-brand oxybate patient segment and capitalizing on the market expansion momentum we are building.

    我們正在加強對羥丁酸鹽患者的直接行銷力度,以加速羥丁酸鹽患者的教育和激活,以要求使用 LUMRYZ,同時繼續追求在新品牌羥丁酸鹽患者領域的市場領導地位,並利用我們正在建立的市場擴張勢頭。

  • And lastly, we'll continue our focus on increasing our reimbursed patient mix towards 80% and beyond with an account and channel-specific strategies.

    最後,我們將繼續致力於透過針對帳戶和管道的策略將報銷患者比例提高到 80% 甚至更高。

  • If patient demand is priority one, persistency improvements are priority 1A.

    如果患者需求是第一要務,那麼持久性改進就是 1A 優先事項。

  • Moving to slide 11, the narcolepsy market has had long-standing challenges with successfully keeping patients on oxybate therapy.

    轉到第 11 張投影片,嗜睡症市場在成功讓患者繼續接受羥丁酸鹽治療方面一直面臨長期挑戰。

  • First-generation oxybate have historically experienced more than 50% of new patients discontinuing therapy each year, with approximately half of that in the first 30 days.

    從歷史上看,第一代羥基丁酸鹽治療每年都有超過 50% 的新患者停止治療,其中約一半是在前 30 天內停止治療的。

  • More recently, based on data we have reviewed, the 12-month discontinuation rate for new first-generation oxybate patients is now approximately 65%.

    最近,根據我們審查的數據,新一代第一代羥基丁酸鹽患者的 12 個月停藥率目前約為 65%。

  • This is something we believe hasn't received the attention it deserves as there wasn't any competition.

    我們認為,由於沒有任何競爭,這件事沒有得到應有的關注。

  • But now there is, and for us, it is a priority.

    但是現在有了,並且對我們來說,這是當務之急。

  • Just as we believe LUMRYZ will become the treatment of choice for oxybate eligible people with narcolepsy, we're equally committed to being the leader in persistency as well, helping ensure patients have their own personal optimal LUMRYZ treatment experience and the associated benefits they deserve.

    正如我們相信 LUMRYZ 將成為適合使用羥丁酸鹽的嗜睡症患者的首選治療方法一樣,我們同樣致力於成為堅持不懈的領導者,幫助確保患者擁有自己最佳的 LUMRYZ 治療體驗以及他們應得的相關益處。

  • For LUMRYZ, we expect that persistency would be impacted, as our patient mix became more heavily weighted to new to oxybate patients and our cumulative cohort of existing patients grew.

    對於 LUMRYZ,我們預計持久性會受到影響,因為我們的患者結構變得更加偏向於新接受羥基丁酸鹽治療的患者,並且我們現有患者的累積群體也在增長。

  • This expectation has materialized, as our new to oxybate patient cohort is growing, which from a persistency perspective is being addressed with accidents we believe, will improve this important metric.

    這項預期已經實現,因為我們的新服用羥基丁酸鹽的患者群體正在不斷增長,從持久性的角度來看,我們相信透過處理事故將改善這一重要指標。

  • As it states on slide 12, specifically, what we know is adverse events are one of the primary reasons for discontinuation.

    如第 12 張投影片所述,具體來說,我們知道不良事件是停藥的主要原因之一。

  • These tend to be common oxybate specific side effects, such as nausea, dizziness and vomiting that typically occur when starting or increasing a dose and depending on severity, can lead to potential discontinuations.

    這些往往是常見的羥基丁酸鹽特異性副作用,例如噁心、頭暈和嘔吐,通常在開始或增加劑量時發生,並且根據嚴重程度,可能會導致停藥。

  • However, they generally subside within one to two weeks, providing an opportunity to impact this by ensuring expectations are appropriately set with patients and deploying timely patient-specific interventions.

    然而,這些症狀通常會在一到兩週內消退,透過確保適當設定患者的期望並及時部署針對患者的干預措施,為影響這一點提供了機會。

  • This is important because as patients progress to their steady-state dose and efficacy increases, satisfaction with their treatment increases and the likelihood of discontinuation declines, especially early in a patient's treatment as nearly two-thirds of discontinuations occur in the first 90 days, thus, providing a very clear window and opportunity to deploy patient-specific tailored messaging.

    這一點很重要,因為隨著患者劑量逐漸達到穩態並且療效逐漸提高,對治療的滿意度隨之提高,停藥的可能性隨之下降,特別是在患者治療早期,因為近三分之二的停藥發生在前 90 天,因此,這為部署針對患者量身定制的信息傳遞提供了一個非常明確的窗口和機會。

  • And even though LUMRYZ persistency rates are higher than that of the first-generation oxybates, that is neither good enough nor the appropriate standard.

    儘管 LUMRYZ 的持久率高於第一代羥基丁酸鹽,但這還不夠好,也不是合適的標準。

  • This year, we believe there's an opportunity to improve the overall persistency rate, which begins by impacting the first 90 days of treatment and stabilizing the overall discontinuation rate.

    今年,我們相信有機會提高整體堅持率,首先影響治療的前 90 天並穩定整體停藥率。

  • Transitioning to slide 13.

    轉換至幻燈片 13。

  • To address this, we have recently made meaningful changes to both our strategy and our resources, including: doubling our nursing team and our patient services center, allowing for more frequent and tailored patient interventions, including prior to the start of therapy to better set treatment expectations; increasing our field support to deliver physician-specific interventions in advance of their patient's LUMRYZ refill; expanding our partnership with our specialty pharmacies, deploying custom pharmacy-based compliance and persistency programs; and lastly, progressing additional field-based patient support services that can go beyond the traditional telephonic and digital intervention tools to a more direct personal high-touch intervention at the patient and physician office level.

    為了解決這個問題,我們最近對我們的策略和資源做出了有意義的改變,包括:將我們的護理團隊和患者服務中心擴大一倍,以便進行更頻繁和更有針對性的患者乾預,包括在治療開始之前更好地設定治療預期;增加我們的現場支持,以便在患者補充 LUMRYZ 之前提供針對醫生的干預措施;擴大與專業藥房的合作夥伴關係,部署基於藥房的客製化合規性和持久性計劃;最後,推動額外的現場為基礎的病患支援服務,超越傳統的電話和數位介入工具,在病患和醫師辦公室層級進行更直接的個人高接觸介入。

  • All these investments are designed with the goal of improving persistency, both early in and throughout a LUMRYZ patient's treatment experience by delivering the right message to the right patient at the right time.

    所有這些投資都是為了透過在正確的時間向正確的患者傳遞正確的訊息來提高 LUMRYZ 患者治療初期和整個治療過程中的持久性。

  • So wrapping up, we are committed to leading the wafer patients in persistency and beyond, all the while providing the opportunity to free oxybate-eligible people with narcolepsy from forcibly waking up in the middle of the night after night for a condition that as FDA stated is antithetical to the goal of improving sleep.

    總而言之,我們致力於帶領威化餅患者堅持不懈,同時為患有嗜睡症且適合使用羥丁酸鹽的患者提供機會,使他們不再因為 FDA 所稱的這種情況而夜夜被強行喚醒,從而改善睡眠質量。

  • Now to translate this into our Q4 results and 2025 financial expectations, let me turn it over to Tom.

    現在,為了將其轉化為我們的第四季業績和 2025 年財務預期,讓我將其交給湯姆。

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Thanks, Greg.

    謝謝,格雷格。

  • We'll start with how we currently estimate 2024 will wrap up, followed by our expectations for 2025 and beyond.

    我們首先會先預測 2024 年的結束情況,然後再預測 2025 年及以後的前景。

  • Moving to slide 14.

    移至投影片 14。

  • I'll highlight a few preliminary 2024 fourth-quarter results and we'll provide more detail when we announce full year earnings later this quarter.

    我將重點介紹 2024 年第四季的一些初步業績,並將在本季稍後公佈全年收益時提供更多詳細資訊。

  • Starting with Q4.

    從 Q4 開始。

  • We estimate that net revenue will be approximately $50 million compared to $19.5 million in the fourth quarter of 2023.

    我們預計淨收入將約為 5,000 萬美元,而 2023 年第四季為 1,950 萬美元。

  • We also estimate Q4 revenue was impacted by approximately $6 million as there was about 1.5 less weeks of inventory in the channel at the end of Q4 versus the end of Q3.

    我們還估計,第四季度的收入受到了約 600 萬美元的影響,因為與第三季末相比,第四季末通路中的庫存減少了約 1.5 週。

  • GAAP operating expenses are expected to come in at approximately $50 million.

    根據 GAAP,預計營業費用約為 5,000 萬美元。

  • And excluding about $6 million of noncash charges for stock-based compensation and depreciation and amortization, cash operating expenses are estimated approximately $44 million.

    除去約 600 萬美元的股票薪資、折舊和攤提非現金費用,現金營運費用估計約 4,400 萬美元。

  • Importantly, our cash flow metric continues to improve and cash flow for the quarter was positive and netting cash will be approximately $73 million at December 31, versus $66 million at September 30.

    重要的是,我們的現金流指標繼續改善,本季的現金流為正,12 月 31 日的淨現金約為 7,300 萬美元,而 9 月 30 日為 6,600 萬美元。

  • With respect to some key patient metrics, there were over 600 patient starts during the quarter, resulting in an increase of over 200 patients on therapy.

    就一些關鍵的患者指標而言,本季有超過 600 名患者開始接受治療,導致接受治療的患者增加了 200 多名患者。

  • We saw a slowdown in the conversion enrollment to patients starting therapy as we enter the holiday season.

    隨著假期的到來,我們發現開始接受治療的患者轉化登記速度有所放緩。

  • And after the holiday impact, we believe that patient starts would have been consistent with the 700 per quarter pace of the first three quarters of the year.

    並且,在假期影響之後,我們認為,新屋開工數將與今年前三個季度每季 700 棟的速度保持一致。

  • During 2024, there were more than 2,700 patient starts and over 3,700 since launch, and all of which results in 2,500 patients on therapy as of December 31, compared to 900 at the end of last year.

    2024 年,已有超過 2,700 名患者開始接受治療,自推出以來已有超過 3,700 名患者接受治療,截至 12 月 31 日,共有 2,500 名患者接受治療,而去年年底為 900 名。

  • I'll turn now to slide 15 and current expectations for 2025.

    我現在轉到第 15 張投影片,討論對 2025 年的當前預期。

  • Earlier, Greg reviewed our key launch priorities, and depending on the execution of guess those as well as other plans and assumptions, we are projecting the following full year results.

    在此之前,格雷格回顧了我們的主要發布重點,根據這些重點以及其他計劃和假設的執行情況,我們預測了以下全年業績。

  • Revenue is projected to be in the range of $240 million to $260 million, which represents about a 50% increase at the midpoint of guidance over 2024 full year revenue.

    預計收入在 2.4 億美元至 2.6 億美元之間,這比 2024 年全年收入的指導中位數增長約 50%。

  • We believe that 2025 is forecasted with an appropriate degree of conservatism regarding patient starts and picture mix, which are winning more heavily to do oxybate patients and revenue could be higher with improvements in several key assumptions such as patient demand, patient mix and persistency.

    我們認為,對 2025 年的預測在患者開始和圖片組合方面採取適當程度的保守態度,這些對羥基丁酸鹽患者更為有利,並且隨著患者需求、患者組合和持久性等幾個關鍵假設的改善,收入可能會更高。

  • We have a highly leverageable cost structure, we also expect that cash flow for 2025 will be positive and in the range of $20 million to $40 million, and that we can fund the ongoing launch in Phase 3 IH study from cash on hand and cash flow from operations.

    我們擁有高度可槓桿的成本結構,我們還預計 2025 年的現金流將為正,在 2000 萬美元至 4000 萬美元之間,並且我們可以利用庫存現金和經營活動現金流為正在進行的第三階段 IH 研究的啟動提供資金。

  • I'll wrap up my commentary on slide 16 with what we believe and how we can achieve the $1 billion-plus revenue opportunity for LUMRYZ.

    我將在第 16 張投影片上結束我的評論,闡述我們的信念以及我們如何為 LUMRYZ 實現 10 億美元以上的收入機會。

  • We expect that over the next several years, LUMRYZ nwill become the leading oxybate therapy for the treatment of narcolepsy, and that the oxybate market will continue to expand just as we have seen since the launch of LUMRYZ.

    我們預計,在未來幾年內,LUMRYZ 將成為治療發作性睡病的領先羥基丁酸鹽療法,並且羥基丁酸鹽市場將持續擴大,正如我們自 LUMRYZ 推出以來所看到的那樣。

  • The path towards achieving $1 billion of revenue is straightforward, requiring constant base of approximately 8,000 LUMRYZ patients.

    實現 10 億美元收入的道路很簡單,只需要大約 8,000 名 LUMRYZ 患者的穩定基礎。

  • In 18 months in the launch, we are nearly 25% of the way towards achieving that goal with over 1,800 reimbursed patients on therapy.

    自推出以來的 18 個月裡,我們已經完成了接近 25% 的目標,已有超過 1,800 名報銷患者接受了治療。

  • And with three patient segments totaling over $50,000 -- 50,000 patients, there are multiple paths to gain the number of reimbursed patients needed to achieve $1 billion of sales.

    而且,由於患者分為三個群體,總計超過 50,000 名患者,因此有多種途徑可以獲得實現 10 億美元銷售額所需的報銷患者數量。

  • However, for example, with only 30% of the 50,000 patients initiate treatment with LUMRYZ and factoring and persistency, LUMRYZ will become a $1 billion-plus product, all of which is being built on a highly leverageable operating structure poised for significant cash generation and earnings.

    但是,例如,在 50,000 名患者中,只有 30% 開始使用 LUMRYZ 進行治療,考慮到持久性,LUMRYZ 將成為價值 10 億美元以上的產品,所有這些都建立在高度可槓桿化的營運結構之上,有望產生可觀的現金和收益。

  • At current gross margins, projected GAAP operating expenses and our existing tax and capital structure, we estimate they're reaching $1 billion of revenue will yield approximately $6 of diluted earnings per share.

    根據目前的毛利率、預計的 GAAP 營運費用以及我們現有的稅收和資本結構,我們估計他們達到 10 億美元的收入將產生每股約 6 美元的稀釋收益。

  • And with that, I'll turn the call back to Greg.

    說完這些,我就把電話轉回給格雷格。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Thank you, Tom.

    謝謝你,湯姆。

  • Before we wrap up and open it to Q&A, let me provide a brief update on the work we're doing with our life cycle management programs on slide 17.

    在我們結束並開始問答之前,讓我在第 17 張投影片上簡要介紹我們針對生命週期管理計畫所進行的工作。

  • First and foremost, we have a sustainable high-growth franchise in LUMRYZ that can drive significant long-term value with current patent protection to early 2042, and that value opportunity extends potentially beyond that of LUMRYZ and narcolepsy.

    首先,我們擁有 LUMRYZ 的可持續高成長特許經營權,透過目前的專利保護到 2042 年初,可以帶來顯著的長期價值,而且這種價值機會可能超出 LUMRYZ 和嗜睡症的範圍。

  • As previously stated, we are conducting our Phase 3 REVITALYZ trial in idiopathic hypersomnia, or IH, which is currently enrolling as planned and is expected to be completed in the second half of this year.

    如前所述,我們正在進行特發性嗜睡症(IH)的 III 期 REVITALYZ 試驗,目前正在按計劃招募患者,預計今年下半年完成。

  • Of note, we have a legal matter we must resolve around the potential NDA filing and approval of LUMRYZ in IH.

    值得注意的是,我們必須解決有關在 IH 中提交潛在 NDA 和批准 LUMRYZ 的法律問題。

  • Assuming we are successful in this regard, we currently expect to be able to file the NDA approximately six months post completion of our pivotal trial.

    假設我們在這方面取得成功,我們目前預計能夠在關鍵試驗完成後約六個月提交保密協議 (NDA)。

  • We have become quite bullish on the potential prospects of LUMRYZ in IH, both because of what we've learned and what we hear directly from clinicians and leading key opinion leaders.

    我們對 LUMRYZ 在 IH 領域的潛在前景非常樂觀,這既是基於我們自身了解的情況,也是基於我們從臨床醫生和主要關鍵意見領袖那裡直接聽到的情況。

  • As stated on slide 18, there are approximately 42,000 diagnosed IH patients under the care of physicians, yes, less than 8% are being treated with the only FDA-approved treatment.

    正如幻燈片 18 所述,大約有 42,000 名確診為 IH 的患者正在接受醫生的護理,是的,只有不到 8% 的患者正在接受唯一經 FDA 批准的治療。

  • What we hear from clinicians is that many patients due to their deep sleep inertia associated with IH cannot physically wake up in the middle of the night to take a second dose and therefore, are not able to benefit from a full therapeutic treatment.

    我們從臨床醫生那裡聽說,許多患者由於與 IH 相關的深度睡眠慣性,無法在半夜醒來服用第二劑藥物,因此無法從全面的治療中受益。

  • As such, we routinely hear that the LUMRYZ value propositions, proposition for patients is potentially even greater in IH than in narcolepsy.

    因此,我們經常聽到 LUMRYZ 的價值主張,對於 IH 患者而言,其價值主張可能比對於嗜睡症患者更大。

  • In addition, our formulation scientists continue to work with our third-party partners in developing a once-nightly lower no sodium oxybate formulation, having a target product profile bioequivalent to LUMRYZ.

    此外,我們的配方科學家繼續與第三方合作夥伴合作開發每晚一次的低無羥基丁酸鈉配方,其目標產品特性與 LUMRYZ 生物等效。

  • And if successful, we intend to pursue FDA approval for this product to treat both narcolepsy and IH.

    如果成功的話,我們打算尋求 FDA 批准該產品用於治療嗜睡症和IH。

  • Turning to slide 19.

    翻到第 19 張投影片。

  • As we start the new year, key milestones for this year include our quarterly financial and launch-related results include revenue, patient demand, patient mix, and net patients on therapy.

    隨著新的一年的開始,今年的關鍵里程碑包括我們的季度財務和發布相關結果,包括收入、患者需求、患者結構和接受治療的淨患者。

  • This is the successful completion of our pivotal IH trial and progress toward NDA filing readiness, updates on our no low-sodium development programs, and of course, our continued progress in ongoing litigation matters as previously noted, including the November antitrust jury trial against Jazz, as well as the advancement of our recent patent infringement suits we filed against Jazz to protect our one slightly oxybate innovation.

    這是我們關鍵的 IH 試驗的成功完成和 NDA 申請準備的進展,也是我們無低鈉開發計劃的更新,當然還有我們在之前提到的正在進行的訴訟事宜中的持續進展,包括 11 月針對 Jazz 的反壟斷陪審團審判,以及我們最近針對 Jazz 提起的專利侵權訴訟的進展,以保護我們的一項略帶氧化丁酸鹽的創新。

  • Moving to slide 20.

    移至第 20 張投影片。

  • In closing, we have built a strong demand-based foundation for LUMRYZ, which continues.

    最後,我們為 LUMRYZ 建立了強大的基於需求的基礎,而這個基礎將持續下去。

  • We're investing in the areas to accelerate the launch and address the challenges in our pursuit of the $1 billion LUMRYZ potential.

    我們正在多個領域進行投資,以加速發布並應對挑戰,實現 10 億美元的 LUMRYZ 潛力。

  • We're advancing our life cycle management programs that offer, if successful, a significant expanded oxybate market opportunity for LUMRYZ, all of which is ported by robust intellectual property portfolio extending into early 2042, a portfolio we are continually expanding.

    我們正在推進我們的生命週期管理計劃,如果成功,將為 LUMRYZ 提供顯著擴大的氧化物市場機會,所有這些都通過延續到 2042 年初的強大知識產權組合進行移植,而這個組合正在不斷擴大。

  • LUMRYZ is represents a meaningful value-creating opportunity built on a highly leverageable cost structure, which should result in significant cash and EPS generation over the coming years and through its patent life.

    LUMRYZ 代表著一個有意義的價值創造機會,建立在高度可槓桿的成本結構之上,這將在未來幾年以及在其專利有效期內帶來大量現金和每股收益。

  • Furthermore, this cash generation foundation creates potential optionality to invest in the growth of Avadel and/or return capital to our shareholders.

    此外,這個現金創造基礎創造了投資 Avadel 成長和/或向股東返還資本的潛在選擇權。

  • In 2025, we look forward to many more stories like our ER nurse practitioner from Texas.

    2025 年,我們期待看到更多像我們來自德州的急診室執業護理師一樣的故事。

  • We're optimistic for the future and look forward to providing additional commercial updates as appropriate.

    我們對未來充滿樂觀,並期待在適當的時候提供更多商業更新。

  • We thank you for your time today and as always for your support.

    我們感謝您今天抽出時間並一如既往地感謝您的支持。

  • We will now open the line for Q&A.

    我們現在將開通問答熱線。

  • Operator?

    操作員?

  • Operator

    Operator

  • (Operator Instructions) François Brisebois, Oppenheimer.

    (操作員指令)François Brisebois,Oppenheimer。

  • François Brisebois - Analyst

    François Brisebois - Analyst

  • Hey, guys, thanks for the questions and the update.

    嘿,夥計們,感謝你們的提問和更新。

  • I just wanted to better understand a little bit, maybe, Tom, if you can go into if we just kind of see the patients on therapy and we see the sales, right, there's the net revenue per patient that you kind of look at, that comes in at a certain number.

    我只是想更了解一點,也許,湯姆,如果你可以詳細說明一下,如果我們只是看到接受治療的患者,我們看到銷售額,對吧,你會看到每個患者的淨收入,這個數字是一定的。

  • Can you help us understand how to think about that number going forward?

    您能幫助我們理解今後該如何看待這個數字嗎?

  • Does it change and maybe the change from that number versus third quarter and where it came in?

    它會改變嗎?

  • Because it does seem like your number of patients start was almost in line, the holidays took it off, but 600 was a solid quarter.

    因為看起來您的患者數量一開始幾乎是一致的,假期有所減少,但 600 是一個穩定的季度。

  • So just a little more on the net revenue per patient and how that can get better with reimbursement.

    因此,每位患者的淨收入只要稍微增加一點,就能透過報銷得到更好的改善。

  • Thank you.

    謝謝。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Sure.

    當然。

  • Thanks, Frank.

    謝謝,弗蘭克。

  • And maybe a good starting point is a question you asked at the beginning, which is where patients were at December 31.

    也許一個很好的起點就是您一開始提出的問題,即 12 月 31 日患者的情況如何。

  • And as we're thinking about revenue heading into 2025, we have to make an assumption that a percentage of those patients will discontinue during the course of 2025, which, of course, impacts the exit run rate.

    當我們考慮 2025 年的收入時,我們必須假設其中一定比例的患者將在 2025 年期間停止治療,這當然會影響退出運行率。

  • And then in terms of comparison of Q3 to Q4, we did have net patient adds, perhaps a driver, which we anticipated was going to happen was the change in the inventory level in the channel, which impacted revenue by about $6 million.

    然後,就第三季和第四季的比較而言,我們確實有淨患者增加,也許是我們預計將發生的驅動因素是通路庫存水準的變化,這對收入產生了約 600 萬美元的影響。

  • François Brisebois - Analyst

    François Brisebois - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • And is that $6 million on that note, is that -- the inventory play is something to be expected a little bit.

    那麼,600 萬美元是否意味著庫存的發揮是可以預料到的呢?

  • Was the $6 million more than expected?

    600萬美元是否超出預期?

  • Or was that kind of in line with what you guys expected?

    或者這符合你們的預期嗎?

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Frank, I think from my standpoint, it was in line with what I expected.

    弗蘭克,我認為從我的角度來看,這符合我的預期。

  • We signaled this during the Q3 call that we expected to be fewer weeks of inventory in channel December 31.

    我們在第三季電話會議上表示,預計 12 月 31 日通路庫存週數將減少。

  • And it's really a function of capacity constraints and storage constraints in the specialty pharmacies where they had indicated they were at capacity in Q3.

    這實際上是由於專業藥房的容量限制和存儲限製造成的,他們表示在第三季度他們的容量已經滿了。

  • So I wouldn't take it -- certainly would not take as an indication of any slowdown in demand.

    因此我不會認為——當然不會認為這是需求放緩的跡象。

  • It's just the specialty pharmacies couldn't carry any more than they could at September 30.

    只是專科藥局無法再存下比 9 月 30 日更多的藥品。

  • In a normalized range, I think two to four weeks is a normalized range to think about.

    在正常範圍內,我認為兩到四周是一個需要考慮的正常範圍。

  • It's tough for me to predict what would be in the Q1 or subsequent quarters.

    我很難預測第一季或後續季度會發生什麼。

  • But I would think about inventory at least in the channel in that range of two to four weeks.

    但我會考慮渠道中的庫存至少在兩到四周的範圍內。

  • François Brisebois - Analyst

    François Brisebois - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • And then just lastly, going forward, in terms of metrics to be expected for us to understand better the persistency and the new patients versus the switch patients.

    最後,展望未來,就預期指標而言,我們將更了解持久性以及新患者與轉換患者的情況。

  • Is this something that you'll give clarity on going forward just to see how these actions are going or we don't know yet?

    您是否會就此作出澄清,以了解這些行動的進展情況,還是我們還不知道?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yeah.

    是的。

  • Frank, the way we think about it going forward is patient demand in the form of patient starts patient mix in terms of source of patients, and of course, net patients on therapy.

    弗蘭克,我們對此未來的看法是,患者需求以患者開始的形式呈現,患者來源以患者組合的形式呈現,當然還有接受治療的淨患者。

  • We think all of those metrics will provide the sort of clarity you're looking for.

    我們認為所有這些指標都會提供您所尋求的清晰度。

  • François Brisebois - Analyst

    François Brisebois - Analyst

  • Perfect.

    完美的。

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Andrew Tsai, Jefferies.

    傑富瑞 (Jefferies) 的 Andrew Tsai。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • Thank you for sharing the progress and expectations.

    感謝您分享進展和期望。

  • So maybe the first question around the guidance on the patient numbers.

    因此,第一個問題可能是有關患者人數的指導。

  • If I take the midpoint of patients initiating therapy in 2025, I think that's I'm assuming that's on top of the 3,700 you have today.

    如果我取 2025 年開始治療的患者數量的中點,我想這個數字將高於今天的 3,700 名。

  • And if that's the case, then taking that resulting number and then working out the math with the patients on LUMRYZ guidance that you have at the midpoint.

    如果確實如此,則取得結果數字,然後根據中間點的 LUMRYZ 指導與患者一起計算數學結果。

  • Basically, is it correct to think that the implied discontinuation rate by year-end 2025 could be closer to 50%?

    基本上,到 2025 年底的隱含停產率可能接近 50% 的想法正確嗎?

  • I'll start off with that.

    我先從那裡開始。

  • Thank you.

    謝謝。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • Yeah.

    是的。

  • Listen, Andrew, I don't disagree with your math.

    聽著,安德魯,我不反對你的數學。

  • So that is what it implies.

    這就是它的意義。

  • This is one of those areas we think there's really great opportunity for improvement versus our current assundants, which is why we've made the investments we've made around persistency and driving patient demand.

    我們認為,與我們目前的豐富資源相比,這是一個有很大改進機會的領域之一,這也是我們在堅持不懈和推動患者需求方面進行投資的原因。

  • Look, we believe we've taken an appropriate approach towards forecasting 2025 at a conservative level.

    看起來,我們相信我們已經採取了適當的方法來保守地預測 2025 年。

  • And what we are thinking about for 2025 is that we're going to be more heavily weighted towards new to oxybate patients, which does impact overall persistency.

    我們對 2025 年的考慮是,我們將更加重視新接受羥基丁酸鹽治療的患者,這確實會影響整體的持久性。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • Thanks.

    謝謝。

  • And I guess, I'd have to think about it more, but you did mention how your current guidance is conservative, but it makes me think how conservative is this.

    我想,我得再考慮一下,但你確實提到你目前的指導是保守的,但這讓我思考這有多保守。

  • Ultimately, how much higher could these revenues be ultimately?

    最終這些收入能提高多少呢?

  • Do you have actually a little bit more color around that?

    您實際上是否對此有更多的了解?

  • And then how much is it from the -- in terms of growing patient volume or driving less discontinuations more realistically that can drive higher sales in 2025?

    那麼,從增加患者數量或減少停藥數量的角度來看,有多少因素能夠更現實地推動 2025 年的銷售成長?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Andrew, I think, first of all, I think most important is if we think about the first six quarters of launch, we had a strong start we clearly have hit some challenges with persistency here in the second part of 2024.

    安德魯,我認為,首先,我認為最重要的是,如果我們考慮推出後的前六個季度,我們有一個強勁的開端,但我們顯然在 2024 年下半年遇到了一些持久性的挑戰。

  • And we have taken the actions to address those persistency matters and also ensure our focus on driving switch patients.

    我們已經採取行動解決這些持續存在的問題,並確保我們專注於推動轉換患者。

  • So your question as to which one is more important?

    那麼你的問題是哪一個比較重要?

  • The answer is they're both important.

    答案是它們都很重要。

  • And I'll just again restate that if you look at where we've indexed our efforts early in the launch, in our early adopters.

    我只想再次重申,如果您看看我們在發布初期、在早期採用者中所做的努力。

  • We have actually significantly penetrated that audience, and it's over representative of their potential within the oxybate market.

    我們實際上已經深度滲透到了該受眾群體,並且它在氧化物市場中的潛力已經得到充分體現。

  • If we can continue to replicate that over time, we should have that sort of success and beyond across all patient segments.

    如果我們能夠隨著時間的推移不斷複製這一點,我們應該在所有患者群體中都取得同樣的成功,甚至超越這一點。

  • So we do think there are opportunities to improve and beat, if you will, how we've guided.

    因此,我們確實認為,如果你願意的話,有機會改進並超越我們的指導。

  • I would say at this point, we need to continue to assess the interventions, and the impact of those interventions, and give us opportunity in subsequent quarters to provide more clarity in that regard.

    我想說,此時此刻,我們需要繼續評估這些幹預措施及其影響,並讓我們有機會在接下來的幾個季度中在這方面提供更清晰的解釋。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • And then very last quick question.

    接下來是最後一個快速問題。

  • Maybe you did share on the slides and I missed it, how should we think about the overall mix of your LUMRYZ patients going forward by year-end?

    也許您確實在投影片上分享過而我錯過了,到年底我們應該如何看待您的 LUMRYZ 患者的整體組合?

  • Would you still expect the same proportion that you're seeing right now year-end 2024?

    您仍預期 2024 年底的比例將與現在相同嗎?

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Yeah.

    是的。

  • So Andrew, it's Tom.

    那麼安德魯,我是湯姆。

  • So what we had from the slides, the mix of patients in the fourth quarter was certainly more heavily weighted towards new to oxybate and periods to try discontinued.

    因此,從幻燈片中我們可以看出,第四季度的患者結構無疑更偏向於新使用羥基丁酸鹽的患者和嘗試停藥一段時間的患者。

  • As we're looking into 2025, and again, I would view this as one of those assumptions we made on a more conservative basis.

    當我們展望 2025 年時,我再次認為這是我們在較保守的基礎上所做的假設之一。

  • We think we're going to continue to be overweighted in terms of new to oxybate and try this continued in improving the patient mix will certainly drive an improvement in revenue.

    我們認為,我們將繼續在新的氧丁酸鹽方面保持超重,並嘗試繼續改善患者結構,這肯定會推動收入的提高。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • Thank you so much.

    太感謝了。

  • Operator

    Operator

  • Marc Goodman, Leerink.

    馬克古德曼,Leerink。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • Yeah, a couple of things.

    是的,有幾件事。

  • First, I may have missed this, but the average selling price was what?

    首先,我可能忽略了這一點,但平均售價是多少?

  • Like, if it was $100,000 in the second quarter and $96,000 in the third quarter, what was it in the fourth quarter?

    例如,如果第二季是 10 萬美元,第三季是 96,000 美元,那麼第四季是多少?

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Mark, it's Tom.

    馬克,我是湯姆。

  • So listen, preliminarily, of course, we're still closing the books, but it averaged about $96,000 if you just take the revenue reported and adjusted for the inventory of $6 million.

    所以聽著,當然,初步而言,我們還在結帳,但如果你只拿報告的收入並根據 600 萬美元的庫存進行調整,平均收入約為 96,000 美元。

  • Divide that by the average number of patients out there, it works out about $96,000 for the quarter.

    用該數字除以平均患者人數,可得出本季的費用約為 96,000 美元。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • So apples to apples, it's about -- so it's the same in the third quarter?

    那麼,就同類情況而言,第三季的情況也一樣嗎?

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • In the third quarter.

    在第三季。

  • That's right.

    這是正確的。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • Okay, fine.

    好的,很好。

  • And then just secondly, historically, when -- I mean, in order to get to $1 billion, are you basically counting on the IH indication?

    其次,從歷史上看,當——我的意思是,為了達到 10 億美元,你基本上是依靠 IH 指標嗎?

  • Is that we're counting on?

    這就是我們所指望的嗎?

  • I mean when a product goes to $170 million to $250 million, I mean, obviously, a new indication can change the growth trajectory.

    我的意思是,當產品的銷售額達到 1.7 億到 2.5 億美元時,顯然一個新的適應症可以改變成長軌跡。

  • But outside of that, we're used to seeing growth rates that kind of slow each after year.

    但除此之外,我們已經習慣看到成長率逐年放緩。

  • So we have to be thinking that this indication slows a little bit over the next couple of years in growth rates.

    因此,我們必須認為,未來幾年的成長率將會有所放緩。

  • It's to going to come $1 billion in narcolepsy, right?

    嗜睡症治療費用將達到 10 億美元,對嗎?

  • This is arcilepsy and IH.

    這就是肌痙攣和免疫性高血壓。

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Mark, the way we think about it, what we've talked about in terms of $1 billion opportunity excludes IH.

    馬克,我們認為,我們所談論的 10 億美元機會不包括 IH。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • So can you talk about -- is there an expectation that 2025 is a growth year of 40%-something, whatever the number is to get to the midpoint?

    那麼您能否談談——是否預計 2025 年將是一個增長 40% 左右的年份,無論達到中點的數字是多少?

  • And then it actually is faster in 2026?

    那麼到 2026 年它實際上會更快嗎?

  • I mean, because traditionally, that's not normally what we see.

    我的意思是,因為傳統上,這不是我們通常看到的情況。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yeah.

    是的。

  • I think, Mark, our perspective is there is a significant amount of patient opportunity to grow LUMRYZ, whether from the three different patient segments that Tom described and our penetration of those respective patient segments doesn't have to be significant to be able to realign those sorts of numbers only in narcolepsy alone.

    馬克,我認為我們的觀點是,有大量患者機會可以發展 LUMRYZ,無論是從湯姆描述的三個不同的患者群體來看,還是我們對各個患者群體的滲透都不必非常深入,僅就嗜睡症這一疾病而言,就能夠重新調整這些數字。

  • And we've seen those levels of penetration in our early adopter audiences already, right?

    我們已經在早期採用者受眾中看到了這種程度的滲透力,對嗎?

  • So if we can continue to translate that into the broader audience that, we believe over time and the slope of that curve will progress the way it progresses, we can get to those sorts of numbers on patients given the opportunity and what we hear in our market research, right, from that perspective.

    因此,如果我們可以繼續將其轉化為更廣泛的受眾,我們相信隨著時間的推移,該曲線的斜率將按照其發展的方式發展,如果有機會以及我們在市場調查中聽到的情況,我們就可以得到關於患者的那些數字,對吧,從這個角度來看。

  • I will say it's not a -- it certainly is a therapeutic category where consistent growth continuously quarter after quarter after quarter, has been demonstrated, and we believe we can continue to execute and deliver on that return and based on the patient source an opportunity we have and the and what we hear from our research.

    我想說的是,它肯定是一個治療類別,已經證明了其連續幾個季度的持續增長,並且我們相信我們可以繼續執行並獲得回報,並且基於患者來源,我們擁有的機會以及我們從研究中聽到的信息。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • And just last question, because I guess this kind of answers when peak sales or be peak sales would be the year before you go LOE, when are you assuming the LOE?

    最後一個問題,因為我猜這類答案是關於銷售高峰或銷售高峰將是您達到 LOE 的前一年,您假設 LOE 是什麼時候?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yeah.

    是的。

  • We're not defining when peak sales are.

    我們並沒有定義銷售高峰期何時發生。

  • But at this point, as we described in the call, we have patent protection right now through early 2022.

    但目前,正如我們在電話會議中所描述的那樣,我們目前擁有的專利保護將持續到 2022 年初。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Ami Fadia, Needham & Company.

    Ami Fadia,Needham & Company。

  • Ami Fadia - Analyst

    Ami Fadia - Analyst

  • Hi, good afternoon.

    嗨,下午好。

  • Thanks for taking my question.

    感謝您回答我的問題。

  • Can you talk a little bit about what has been the dynamic with which patients?

    您能否稍微談一談患者的狀況動態?

  • And why we've seen a reduced mix of switch patients?

    為什麼我們看到轉換病人的數量減少了?

  • And what your assumption is in your 2025 outlook for what percent of patients will be switch patients?

    您對 2025 年的預測是,有多少比例的患者會成為轉換患者?

  • And what do you think you need to do to really increase that mix?

    您認為需要做什麼才能真正增加這種組合?

  • That's my first question.

    這是我的第一個問題。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yeah.

    是的。

  • Again, I think the data shows what's occurred.

    再次,我認為數據表明了發生了什麼。

  • We've seen early in the launch, a much higher percentage of them.

    我們在發布初期就已經看到,這種比例要高得多。

  • And as we've gotten to the last couple of quarters, it has slowed down and stabilized to a certain extent, in the kind of low to the mid-to-higher 30% of the total patient population -- of our total patient starts.

    進入最近幾個季度,這一趨勢已經減緩並趨於穩定,占到總患者人數的 30% 到 30% 左右。

  • In part, we've gotten, I would say, for lack of a better word, those who are waiting and looking for LUMRYZ.

    在某種程度上,我想說,我們已經得到了那些正在等待和尋找 LUMRYZ 的人。

  • And now we're, and in particular, in our early adopters.

    現在我們已成為早期採用者。

  • And now we are in the market really expanding our reach and investing our efforts to both educate direct the patients through our direct-to-patient activities to educate them and activate them to go seek LUMRYZ.

    現在,我們正在市場上真正擴大我們的覆蓋範圍,並投入我們的努力,透過直接面向患者的活動來教育直接患者,以教育他們並激勵他們去尋求 LUMRYZ。

  • Where we've done that to date, we've seen that be successful, and we've expanded our sales force to expand our reach to be able to get wider and get more frequency into this other 75% of the underpenetrated market opportunity.

    到目前為止,我們所做的一切都是成功的,我們已經擴大了銷售隊伍,擴大了我們的覆蓋範圍,以便能夠更廣泛地、更頻繁地進入另外 75% 的尚未充分滲透的市場機會。

  • And we think in both those scenarios, we're going to continue to see growth in new to oxybate and previously treated and discontinued.

    我們認為,在這兩種情況下,我們將繼續看到新的氧化物和先前已處理並停產的氧化物的增長。

  • And we're focused on accelerating the switch, which if we do those things, our entire demand will grow.

    我們專注於加速轉變,如果我們做到了這一點,我們的整個需求就會成長。

  • Ami Fadia - Analyst

    Ami Fadia - Analyst

  • Got it.

    知道了。

  • Just with regards to your guidance for 2025, you've sort of characterized it as something that has upside.

    就您對 2025 年的指導而言,您將其描述為具有上行潛力的事物。

  • What do you think could be the biggest driver of upside?

    您認為推動股價上漲的最大動力是什麼?

  • And when you talk about the persistency rates of 50% that you've assumed in your guidance, what do you believe you need to do to sort of increase that persistency rate?

    當您談到指導中假設的 50% 的持續率時,您認為需要做些什麼來提高該持續率?

  • And what could drive the persist base to be better than the Jazz products that have been on the market for many years?

    那麼什麼能夠推動 persist 基礎比已經上市多年的 Jazz 產品更好呢?

  • I'll have one quick last question.

    我還有最後一個問題。

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Ami, it's Tom.

    阿米,我是湯姆。

  • I'll take the first part of the question.

    我將回答問題的第一部分。

  • I consider there's really primary assumptions that could drive revenue above the guidance we provided, each one of which is not insignificant and taking a combination in working together provides even more larger results.

    我認為確實存在一些主要假設,這些假設可能會使收入高於我們所提供的指導,每一個假設都不是微不足道的,而結合起來結合起來可以帶來更大的結果。

  • The three assumptions really are just really total patient demand.

    這三個假設其實只是患者的整體需求。

  • And of course, if you drive more patients at the top and you have more net patient adds during the course of the year.

    當然,如果您吸引更多的頂級患者,那麼您在一年內就會有更多的淨患者增加。

  • Patient mix, defined really is the mix of switch patients versus non-switch patients to characterize it simply.

    患者組合,實際上的定義是轉換患者與非轉換患者的組合,以簡單地描述它。

  • That's also a powerful driver of revenue. the higher the mix goes towards switch, the more revenue we believe we generate.

    這也是營收的強大推動力。我們相信,轉換率越高,創造的收入就越多。

  • And the third is persistency, which we believe we're making the right investments to improve that.

    第三是持久性,我們相信我們正在做出正確的投資來改善這一點。

  • But if you take those three, they're individually or in combination, and that clearly would drive us above the organic revenue guidance.

    但如果你把這三者單獨或結合起來看,顯然會讓我們超越有機收入預期。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • And to your question of why do we think we can improve persistency vis-a-vis other products in the category.

    至於您的問題:為什麼我們認為我們可以提高相對於該類別其他產品的持久性。

  • We've already demonstrated that we have higher persistency rates from the data we look at across all patient types and all time periods to date that we've been on the market.

    我們已經證明,從我們觀察的所有患者類型和迄今為止我們進入市場的所有時間段的數據來看,我們的持久率更高。

  • So we have numerically a better persistency rate, if you will.

    因此如果你願意的話,從數值上來說,我們的持久率更高。

  • But from our perspective, with as our patient mix shifted and the opportunity to keep patients on therapy, it's an investment and a priority for us because we work so hard to get them on therapy.

    但從我們的角度來看,隨著我們的患者結構發生變化以及讓患者繼續接受治療的機會,這對我們來說是一項投資,也是首要任務,因為我們非常努力地讓他們接受治療。

  • And we know that when they get through the first 90 days, which is where the majority of the discontinuations occur that their treatment experience and their satisfaction only continues to rise.

    我們知道,當他們度過最初的 90 天(大多數停藥情況都是在這個階段)後,他們的治療體驗和滿意度只會繼續上升。

  • So what we're really deploying is incremental resources deployed in particular, centered around the first 90 days, where we engage with the patient, we engage with the office staff and physicians in an attempt to really positively impact from before they start therapy to at different points in time during their journey, especially in the first 90 days.

    因此,我們真正部署的是增量資源,特別是圍繞前 90 天部署的資源,我們與患者接觸,與辦公室工作人員和醫生接觸,試圖在他們開始治療之前到旅程的不同時間點,特別是在前 90 天,真正產生積極的影響。

  • Now every patient is important and every patient type is important in that regard, whether the first 90 days or beyond and all of our programs are designed to impact everybody in that regard.

    現在,每位患者都很重要,每種類型的患者都很重要,無論是前 90 天還是更長時間,我們所有的計劃都是為了影響每個人而設計的。

  • But the new to oxybate and the previously treated and discontinued have markedly higher discontinuation rates than the switch patients, which -- why the mix of patient matters in that regard, why a focus on switch patients is important as well.

    但是,新使用羥基丁酸鹽的患者和之前接受過治療並停藥的患者停藥率明顯高於更換患者,這就是為什麼患者組合在這方面很重要,為什麼關注更換患者也很重要。

  • But also, we have to have the tools and tactics to try to meet the patient where they are and help them stay on therapy, which is something we haven't done until recently.

    但同時,我們必須有工具和策略來盡力滿足患者的需求並幫助他們堅持治療,這是我們直到最近才做的事情。

  • Ami Fadia - Analyst

    Ami Fadia - Analyst

  • Understood.

    明白了。

  • Okay.

    好的。

  • Just last quick question.

    最後一個快速問題。

  • Just could you elaborate on where the appeal to the injunction on IH is at?

    您能詳細說明一下對 IH 禁令的上訴在哪裡嗎?

  • And what stage of the litigation we are at?

    我們處於訴訟的哪個階段?

  • And when we can expect a decision?

    我們什麼時候可以得到決定?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • All I can say on the appeal of the IH appeal is that the oral arguments, I believe, are scheduled for February 7.

    關於 IH 上訴,我唯一能說的是,我相信口頭辯論將於 2 月 7 日進行。

  • And then we would -- subsequent to that, we would expect the decision sometime from the appellate court sometime thereafter, right?

    然後我們會 — — 在此之後,我們預計上訴法院會在稍後的某個時候做出判決,對嗎?

  • When that is, I'm not really sure.

    我不太確定那是什麼時候。

  • The last time we were in front of that group on the REV-related patents, we had a decision in fairly quick short order.

    上次我們在小組面前討論 REV 相關專利時,我們很快就做出了決定。

  • But it could also be later in Q1 or early in Q2, we don't know.

    但也可能是在第一季末或第二季初,我們不知道。

  • But the oral arguments are February set.

    但口頭辯論定於二月進行。

  • Operator

    Operator

  • Olive -- one moment, please.

    奧利佛 —— 請稍等一下。

  • From H.C. Wainwright, but I cannot read the name.

    來自 H.C.溫賴特,但我看不懂這個名字。

  • Oren Livnat - Analyst

    Oren Livnat - Analyst

  • Thanks.

    謝謝。

  • It's Oren.

    是奧倫。

  • Can you hear me?

    你聽得到我嗎?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • Oren Livnat - Analyst

    Oren Livnat - Analyst

  • Great.

    偉大的。

  • Can you just talk a little bit more -- and I'm sorry, I have to jump on it off this call, so I'm sorry if you addressed it.

    你能再多講一點嗎——很抱歉,我必須掛斷電話,所以如果你提到了這個問題,我很抱歉。

  • But can you talk more about these interventions?

    但您可以進一步談談這些幹預措施嗎?

  • I think you said they're sort of beyond traditional telephonic and digital interventions, presumably, I don't know if that's mostly on the post-initiation patient support side?

    我想您說過它們超越了傳統的電話和數位幹預,大概是這樣,我不知道這是否主要是在啟動後患者支持方面?

  • Or this is on the free initiation education side with doctors and/or patients?

    還是這是針對醫生和/或病人進行的免費啟蒙教育?

  • Just talk more about what are you doing differently that you didn't do before?

    多談談您正在做哪些與以前不同的事情?

  • And why that wouldn't have occurred you to do initially?

    那為什麼您最初沒有想到要這麼做呢?

  • And also, maybe I missed this as well, but is the mix of patients that you're at now at this stage in the launch meaningfully different than you would have expected?

    另外,我可能也忽略了這一點,但在發表會的這個階段,您目前的病患結構是否與您預期的有顯著不同?

  • And why do you think that is in terms of higher weighting towards new to patients?

    您為什麼認為新患者的治療權重較高呢?

  • Is switching existing patients that weren't already warehoused and eager and are unhappy and waiting to switch to something.

    正在轉換那些尚未入庫、急切想要轉換但又不滿意並等待轉換的現有患者。

  • Is that proving harder than you expected?

    這是否比你想像的還要難?

  • Are patients just seeing their doctors less often than you expected?

    患者就診的次數是否比您預期的少?

  • Can you just talk more about all of that?

    能進一步談談這些嗎?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • Oren, in terms of the initiatives that we're taking on relative to persistency, whether it's the expansion of our nurses, whether it's the expansion of our field sales team, whether it's our partnerships with our specialty pharmacies or the additional fuel-based opportunities that we're evaluating and progressing.

    奧倫,就我們在堅持不懈方面採取的舉措而言,無論是擴大我們的護士隊伍,還是擴大我們的現場銷售團隊,無論是與我們的專業藥房建立合作夥伴關係,還是我們正在評估和推進的額外的燃料機會。

  • I would say all of them are things we hadn't been doing until recently.

    我想說這些都是我們最近才開始做的事情。

  • So we continue to advance those capabilities from that perspective, and assess their impact and how they are effectively improving the patient's treatment experience.

    因此,我們從這個角度不斷推進這些能力,並評估它們的影響以及它們如何有效地改善患者的治療體驗。

  • So I think the one thing we've learned over the course of -- in particular, the last number of months is that the notion of one size fits all isn't the right approach, right?

    因此,我認為,我們在過去幾個月中學到的一件事是,一刀切的觀念並不是正確的做法,對嗎?

  • Each patient type has their own different nuance.

    每種患者類型都有其不同的細微差別。

  • And how we intervene based upon the patient is really, really important.

    我們如何根據患者的情況進行幹預真的非常重要。

  • And we continue to get smarter as we talk to patients about that and how we can become more, if you will, almost predictive in terms of who's at risk of a discontinuation and how do we deploy interventions in advance of that to prevent it, right, from that standpoint.

    當我們與患者談論這個問題時,我們會變得更加聰明,我們會更準確地預測誰有停藥的風險,以及我們如何提前部署幹預措施來預防這種情況,從這個角度來看。

  • So in terms of your comment about your question about switch patients.

    因此,就您對更換病人的問題的評論而言。

  • I think the first thing I would comment is that the switch opportunity is robust for us, and it hasn't changed, and it still represents respectfully, the largest portion of our patient starts, right?

    我認為我要評論的第一件事是,轉換機會對我們來說是強勁的,而且它沒有改變,它仍然代表著我們最大一部分患者的開始,對嗎?

  • It's left.

    還剩下。

  • And I think that is in part because of the -- some of the low-hanging crew we got.

    我認為這在一定程度上是因為我們有一些低調的工作人員。

  • And I think we're now in a rare disease where we are unlocking patients.

    我認為我們現在正處於一種罕見疾病之中,我們正在為患者解鎖新方法。

  • We are in offices and online, communicating to patients and physicians, to give them the reasons why they should or should consider LUMRYZ.

    我們在辦公室和網路上與病人和醫生溝通,告訴他們為什麼應該或應該考慮 LUMRYZ。

  • And we've got a lot of research in this regard, and we noted some of that research.

    我們在這方面進行了大量研究,並記錄了其中的一些研究。

  • Some of that -- some of the concerns or hesitation is centered around reimbursement or concerns about out-of-pocket cost, which certainly isn't an issue for us, but certainly it's something that we've got to make sure patients understand as one example of the things that they're comfortable with as they consider changing a therapy in a rare disease where only a handful of small subset of physicians have a lot of patients, most have a few patients and the intervention opportunities aren't regular, like are in larger mass markets.

    其中一些擔憂或猶豫集中在報銷或自付費用方面,這當然不是我們的問題,但我們必須確保患者理解這一點,這是他們在考慮改變罕見疾病治療方法時感到舒服的事情之一,在這種疾病中,只有極少數醫生擁有大量患者,大多數醫生只有少數患者,並且幹預機會並不像在大型大眾市場中那樣定期。

  • Oren Livnat - Analyst

    Oren Livnat - Analyst

  • Okay.

    好的。

  • And there's a lot of moving parts in this guidance, and I'll admit it's a bit in at least on without having a chance more time to dig into it here.

    本指南中有很多活動部件,我承認它至少在某些方面有點超出範圍,因為我沒有機會在這裡花更多時間深入研究它。

  • But just as we think about size of the math of just discontinuation rates, which will hopefully improve on average.

    但正如我們思考停藥率的數學規模時所看到的那樣,希望平均停藥率能有所改善。

  • Is there any sort of phasing or cadence that you expect in this year with regards to some of these new -- all of the above new starts and different patient types coming online with these initiatives?

    針對上述所有新啟動的計劃以及這些計劃中出現的不同類型的患者,您是否預計今年會有一些階段性或節奏上的調整?

  • Is this going to be a back-half weighted?

    這會是後半部加權嗎?

  • I guess it speaks to Mark's question earlier, that will we come out of the year maybe at a higher growth rate than we are in the first half as these initiatives take hold?

    我想這回答了馬克之前的問題,隨著這些措施的實施,我們今年的成長率是否會比上半年更高?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • Oren, maybe I'll start and then maybe Tom can wrap a little bit additional commentary.

    奧倫,也許我先開始,然後湯姆可以再做一點補充評論。

  • I think first, the thing that's very clear to us and even was clear during the first four quarters of launch, where we were building this really strong foundation that the demand at the top of the funnel, whether you measure that in the moment or new patient starts continues to be robust and strong and consistent, and we see that not changing.

    我認為首先,我們非常清楚,甚至在推出後的前四個季度就很清楚,我們正在建立這個非常堅實的基礎,無論是當前還是新患者開始的數量,漏斗頂端的需求都持續強勁、強勁和一致,我們看到這一點沒有改變。

  • The opportunity for that to accelerate is really continuing the growth we're seeing in new to oxybate and switch patients, but add in a growth, if you will, an improvement in switch patients right, from that perspective.

    加速這一進程的機會實際上是繼續我們看到的對羥基丁酸鹽和轉換患者進行新治療的增長,但從這個角度來看,如果你願意的話,還可以增加增長,即轉換患者的改善。

  • So that's why it's a focus for us.

    這就是為什麼它成為我們的關注重點。

  • How long it takes for these investments to take hold and have consistent impact is something we're evaluating all the time.

    我們一直在評估這些投資需要多長時間才能發揮作用並產生持續的影響。

  • I certainly believe that we've gotten our field teams and our nurses team, nursing teams and what not all in place now and trained and operational here as we enter the new year.

    我堅信,在新的一年到來之際,我們的實地團隊、護理團隊、護理團隊以及其他團隊都已經到位,並進行了培訓並投入運作。

  • And we'll continue to assess the effectiveness of those initiatives to be able to both build demand like we think we can and keep patients on therapy like we think we can.

    我們將繼續評估這些措施的有效性,以便既能像我們認為的那樣創造需求,又能像我們認為的那樣讓患者繼續接受治療。

  • Oren Livnat - Analyst

    Oren Livnat - Analyst

  • And just lastly, I'm sorry, did you say how many reps you had and now have in the field?

    最後,抱歉,您有沒有說過您在該領域曾經擁有和現在有多少名代表?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • We've added about 15% on the rep side.

    我們在銷售代表方面增加了約 15%。

  • We've doubled our field support teams, and we've doubled our nurses.

    我們的現場支援團隊和護士人數也增加了一倍。

  • Oren Livnat - Analyst

    Oren Livnat - Analyst

  • Okay.

    好的。

  • How many reps is that out there now?

    現在那裡有多少個代表?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • 53.

    53.

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆,派珀·桑德勒。

  • Unidentified Participant

    Unidentified Participant

  • This is Alex on for David.

    這是亞歷克斯 (Alex) 為戴維 (David) 主持的節目。

  • I've got one question for you.

    我要問你一個問題。

  • Looking ahead at longer-term dynamics, how are you thinking about adoption in IH for LUMRYZ assuming positive data?

    展望長期動態,假設數據為正面,您如何看待 LUMRYZ 在 IH 中的應用?

  • In other words, are you envisioning expanding the market?

    換句話說,您是否打算擴大市場?

  • Or do you see a lot of the LUMRYZ potential here coming at the

    或者你認為 LUMRYZ 在這方面有很大潛力

  • (inaudible)?

    (聽不清楚)?

  • Just sort of help us understand how you're thinking about this opportunity.

    只是幫助我們了解您如何看待這個機會。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • Again, I think without providing a whole lot of commentary around this, given we've got to get through our clinical trial, get through our approval and then deal with the upcoming oral arguments and a fuel process.

    再次,我認為無需對此發表太多評論,因為我們必須通過臨床試驗,獲得批准,然後處理即將到來的口頭辯論和燃料過程。

  • I would say most importantly, and again, the research we've heard most recently and trying to understand the opportunity for LUMRYZ is that there's a whole lot of room here for LUMRYZ to fit in, whether that -- and I think the dynamics that we see in narcolepsy to some extent, although there's more patients being treated with narcolepsy, we think will likely potentially translate into IH to a certain extent.

    我想說,最重要的是,我們最近聽到的研究以及試圖了解 LUMRYZ 的機會是,LUMRYZ 在這裡有很大的適應空間,無論那——我認為我們在發作性睡病中看到的動態在某種程度上,雖然有更多的患者接受發作性睡病治療,但我們認為這可能會在一定程度上轉化為 IH。

  • But the IH penetration today is, again, less than based upon diagnosed patients and what we think are the actual IH patients on therapy with a twice (inaudible) product.

    但是,如今 IH 的滲透率仍然低於基於確診患者的數量以及我們認為使用兩倍(聽不清楚)產品治療的實際 IH 患者的數量。

  • So from our viewpoint, there's a lot of room, both inside what's of those being treated, but even bigger outside of that.

    因此,從我們的角度來看,治療空間很大,不僅在接受治療的患者內部,而且在治療外部也有很大空間。

  • And all indications we have is it's an opportunity to source all of -- from multiple patient segments just that we've seen in narcolepsy accordingly.

    所有跡象表明,這是一個機會,可以從多個患者群體中獲得我們在嗜睡症中所看到的所有資訊。

  • Should we be successful in our clinical program and the related legal matters.

    我們的臨床計劃和相關的法律事務是否能夠成功。

  • Operator

    Operator

  • Ash Verma, UBS.

    瑞銀的 Ash Verma。

  • Ashwani Verma - Analyst

    Ashwani Verma - Analyst

  • I have two.

    我有兩個。

  • So just for 2025, like I've been trying to do math like what are you assuming on pricing?

    那麼就 2025 年而言,我一直在嘗試做數學題,例如您對定價的假設是什麼?

  • It seems like there is some connect even after factoring your 50% persistence.

    即使考慮到你的 50% 堅持,似乎仍然會存在一些聯繫。

  • And I think that typically, in this market, pricing doesn't necessarily get impacted back meaningfully.

    我認為,通常在這個市場中,定價不一定會受到重大影響。

  • So that's the first one.

    這是第一個。

  • And then second, has the recent leadership departure resulted in any kind of disruption in the sales momentum?

    第二,最近領導階層的離職是否對銷售動能造成了任何干擾?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • So I'll take the second question.

    我來回答第二個問題。

  • And from my perspective, the answer to that is no, in terms of disruption from the field.

    從我的角度來看,從現場幹擾的角度來看,答案是否定的。

  • The field is very focused on what they're doing and all of our field leadership team and our commercial leadership team is intact, still operating, and driving the things that need to be driven from that perspective.

    這個領域非常專注於他們所做的事情,我們所有的現場領導團隊和商業領導團隊都完好無損,仍在運作,並從這個角度推動需要推動的事情。

  • So in that point, we don't believe so from what we've experienced so far.

    因此,從目前的經驗來看,我們並不這麼認為。

  • And on the pricing, I'll turn it over to Tom.

    關於定價,我會把它交給湯姆。

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Yes.

    是的。

  • The way I would think about pricing is for a -- listen, for a reimbursed patient who's on for full year, there's really much of a change year over year from 2024 to 2025.

    我對定價的看法是——聽著,對於全年報銷的患者來說,從 2024 年到 2025 年,逐年都會有很大的變化。

  • But what does impact when you get down to an average per patient number on an annual revenue basis is really the patient mix.

    但當你根據年收入計算出平均每個病人的數量時,真正有影響的是病人的結構。

  • And persistency does impact the calculation of the net revenue for switch patients versus a new to oxybate patient.

    持久性確實會影響轉換患者與新服用羥基丁酸鹽患者的淨收入的計算。

  • And while we believe we've forecasted conservatively, that factor, that mix of patients does impact net revenue per patient on an overall basis.

    雖然我們認為我們的預測是保守的,但這個因素,這個患者組合確實會對整體上每位患者的淨收入產生影響。

  • Operator

    Operator

  • Myriam Belghiti, LifeSci Capital.

    Myriam Belghiti,LifeSci Capital。

  • Myriam Belghiti - Analyst

    Myriam Belghiti - Analyst

  • Just one question for me.

    我只想問一個問題。

  • I'm just curious whether the factor is driving discontinuation and the new to oxybate for LUMRYZ differ from those seen in the first-generation oxybate?

    我只是好奇,導致停產的因素是否以及 LUMRYZ 的新型羥基丁酸鹽與第一代羥基丁酸鹽有何不同?

  • You mentioned that historically, those have been quite high.

    您提到,從歷史上看,這些數字一直相當高。

  • So just wondering what gives you the confidence that these new initiatives will mean actually address this issue.

    所以我想知道是什麼讓您有信心這些新舉措將真正解決這個問題。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Well, it's a great question, Miriam.

    嗯,米里亞姆,這個問題問得真好。

  • And I think, ultimately, as we study this and seek to understand what's happening and why there's a few things that really stand out, right, is, number one, as we stated, like across all time points and different patient segments, I would say that we numerically have better discontinuation rates or we like to think higher persistency rates.

    我認為,最終,當我們研究這個問題並試圖了解發生了什麼以及為什麼有幾件事真正引人注目時,對吧,首先,正如我們所說的,例如在所有時間點和不同患者群體中,我會說我們在數值上擁有更好的停藥率,或者我們認為更高的持續率。

  • But not good enough, especially as our patient mix changes, and we're on a total patient population that's smaller, right, with 2,500 patients on therapy.

    但這還不夠好,特別是當我們的患者結構發生變化時,我們的患者總數較少,對吧,只有 2,500 名患者接受治療。

  • So for us, when you -- as we research this, talk to patients, talk to those who have experienced those sorts of things that drive discontinuation it's clear that the majority of it happens early on.

    因此對我們來說,當我們研究這個問題時,與患者交談,與那些經歷過導致停藥的事情的人交談,很明顯,大多數情況都發生在早期。

  • A big driver of that is how their expectations are set and how care is offered to them through the course of dose titration because side effects come with starting and dose titration, yet they do subside over time.

    其中一個重要驅動因素是如何設定他們的期望以及如何在劑量滴定過程中為他們提供護理,因為副作用在開始和劑量滴定過程中會出現,但隨著時間的推移它們會消退。

  • And while you're dose increasing to your steady-state dose to get the ideal therapeutic effect, you're going to have adverse events along the way and helping the patient navigate through those is really, really important.

    當您增加劑量至穩態劑量以獲得理想的治療效果時,您難免會出現不良事件,幫助患者度過這些不良事件真的非常重要。

  • So again, our view is that we can have an impact in this regard.

    因此,我們再次認為我們可以在這方面產生影響。

  • We have made the investments to do that.

    我們已經為此做出了投資。

  • And we continue to deploy those efforts, and we'll have an opportunity to understand over time which ones we think are working the most effectively and how do we double down on those and which ones need to be enhanced and how do we do that?

    我們將繼續部署這些努力,隨著時間的推移,我們將有機會了解哪些努力最有效,我們如何加倍努力,哪些努力需要加強,我們如何做到這一點?

  • Operator

    Operator

  • Chase Knickerbocker, Craig-Hallum.

    蔡斯·尼克博克、克雷格·哈勒姆。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • So I just wanted to dig a little bit more on the efforts on the demand side and how you can improve the mix on what is entering the funnel and kind of maximizing switch patients.

    因此,我只是想進一步深入了解需求方面的努力,以及如何改善進入管道的組合併最大限度地轉換患者。

  • Can you just add a little bit more detail on how you're kind of focusing reps to kind of improve that mix entering the funnel more towards switch patients?

    您能否稍微詳細地介紹一下您如何集中銷售代表,以改善銷售管道,讓其更面向轉換患者?

  • Is there a decent number of kind of medium to high prescribers out there that are still kind of new to you and you still need to reach?

    是否有相當數量的中高級處方藥提供者對您來說還比較陌生,您仍需要接觸他們?

  • Or is it mainly existing writers who have a meaningful cohort of oxybate users who are just sticking with first-generation therapy.

    或者主要是現有的作家擁有一批有意義的羥基丁酸鹽用戶,他們只是堅持第一代療法。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • I would answer it this way, right?

    我會這樣回答,對嗎?

  • I think number one is you got to understand where the physician is on their buying -- kind of in their buying journey, so to speak and their adoption journey of LUMRYZ, right?

    我認為,首先你必須了解醫生的購買情況——可以說是他們的購買歷程,以及他們採用 LUMRYZ 的歷程,對嗎?

  • In some case, we have physicians who have not prescribed.

    在某些情況下,我們的醫生並沒有開處方。

  • We have some high-volume prescription physicians who have not prescribed.

    我們有一些開藥量很大的醫生卻沒有開處方。

  • But by and large, our 25% of the market that's driving two-thirds of our volume to date, where we have really high penetration relatively speaking, has been directly related to our efforts and our promotion, right?

    但總的來說,我們迄今為止佔據的 25% 的市場份額(推動了我們三分之二的銷量)相對而言具有很高的滲透率,這與我們的努力和推廣直接相關,對嗎?

  • So I would say as you get to the other 75%, who may be slower adopters, may be harder to see maybe lower tiered physicians and who have fewer patients.

    所以我想說,對於另外 75% 的人來說,他們可能採用得比較慢,可能更難見到較低階的醫生,而且他們的病人也比較少。

  • And some have a lot of patients it really requires consistent, in our view, consistent focus and commercial execution against it, understanding where that physician is in their kind of adoption sequence.

    有些醫生有很多病人,在我們看來,這確實需要持續的關注和商業執行,了解醫生在他們的採用序列中處於什麼位置。

  • Is this a physician who we should be targeting a switch patient to?

    這是我們該轉診給的醫師嗎?

  • It's just one who we would be starting a new to oxybate with?

    我們只是要和誰一起開始新的氧化反應嗎?

  • Our focus though is to grow all patient demand with an emphasis on how do we unlock more switch patients, right?

    我們的重點是增加所有患者的需求,重點是如何解鎖更多的轉換患者,對嗎?

  • And again, we're working with our teams to deploy those tools and tactics to do that.

    我們正在與我們的團隊合作,部署這些工具和策略來實現這一目標。

  • But there's ample opportunity across all of our segments, recognizing that where we've over-indexed our time, we've done quite well, and that's the way the foundation.

    但是,我們所有的領域都存在充足的機會,我們認識到,在我們過度利用時間的地方,我們做得很好,這就是基礎所在。

  • And now we've got to expand that if we want to keep building and growing and all of our research would tell us that, that can happen, and that's what we're doing.

    現在,如果我們想繼續建造和發展,我們就必須擴大這個範圍,我們所有的研究都告訴我們,這是可以實現的,而這正是我們正在做的事情。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • And just last for me on the persistency side.

    就持久性而言,這對我來說只是最後一次。

  • Is there any kind of early signs of success with any maybe earlier stage pilot programs that you've kind of put in place or specific teams out there in the field in specific geographies who have done better from a persistency rate perspective and kind of that you can share as far as potentially showing early signs of success in some of these efforts that you're instituting?

    您所實施的早期試點計畫是否有任何早期成功的跡象,或者在特定地區實地工作的特定團隊在持續率方面表現更好,您可以分享一下您正在實施的一些努力是否可能顯示出早期成功的跡象嗎?

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Yes.

    是的。

  • Thanks, Chase.

    謝謝,蔡斯。

  • Given most of our resources are just operational now, I would say it's a little bit premature to draw sort of definitive conclusions.

    鑑於我們的大部分資源現在才剛剛投入使用,我認為現在得出明確的結論還為時過早。

  • I would say that what we've really tried to understand, in addition to what's happening at the physician at the patient level is to really understand where discontinuations are an issue at the physician level, right, in terms of perhaps their practice and how they manage patients or what is the result, what is the resulting risk of discontinuation inside of specific physician practices.

    我想說的是,除了了解醫生在患者層面發生的情況之外,我們真正試圖了解的是,真正了解停藥在醫生層面上存在哪些問題,對吧,也許是在他們的實踐中以及他們如何管理患者或結果是什麼方面,在特定的醫生實踐中,停藥的後果是什麼。

  • And taking the opportunity to engage and connect with those physicians who do a really, really good job from them from their perspective and from what the data tells us, learning and deploying and the source of lessons that they deploy, both not only at the patient level but to the physician level as well.

    並藉此機會與那些做得非常出色的醫生進行接觸和聯繫,從他們的角度和數據告訴我們的情況來看,學習和部署以及他們所部署的經驗教訓來源,不僅在患者層面,而且在醫生層面。

  • And that's the reason why we've expanded our resources to be able to do both.

    這就是我們擴大資源以實現這兩項目標的原因。

  • Operator

    Operator

  • Marc Goodman, Leerink.

    馬克古德曼,Leerink。

  • Marc Goodman - Analyst

    Marc Goodman - Analyst

  • Just a follow-up since we're kind of resetting expectations to Tom.

    由於我們正在重新設定對湯姆的期望,因此這只是一個後續問題。

  • First quarters are always a little funky.

    第一季總是有些奇怪的。

  • Maybe you can comment on first quarter a little bit and how to think about it?

    也許您可以對第一季度發表一些評論以及如何看待它?

  • And then second of all, did I see the numbers correct?

    其次,我看到的數字正確嗎?

  • You ended '24 with 2,500 patients you're expecting to end 3,400 patients at the end of this year.

    24 年底,您的醫院有 2,500 名患者,預計今年底將有 3,400 名患者。

  • So like if you just took like a simple average times the price that's the same price as 2024, you get a number that's much above your range.

    因此,如果您只是將簡單的平均值乘以與 2024 年相同的價格,那麼您會得到一個遠超出您的範圍的數字。

  • So what am I doing wrong?

    那我做錯了什麼?

  • Thomas McHugh - Chief Financial Officer

    Thomas McHugh - Chief Financial Officer

  • Let me break it down one by one.

    讓我逐一分解。

  • Look, too early to comment on Q1, Marc.

    馬克,現在對第一季發表評論還為時過早。

  • We'll probably be in a better position to provide an update on that and how we're progressing when we do our Q4 call later this month -- earlier this quarter.

    當我們本月稍後(本季早些時候)召開第四季度電話會議時,我們可能會更好地提供有關此問題的最新進展。

  • In terms of the you're tackling revenue for the year, you have to take 2,500 as we exit therapy, we're projecting a net add of 800 to 1,000 patients.

    就您今年的收入而言,當我們結束治療時,您必須獲得 2,500 名患者,我們預計淨增加 800 至 1,000 名患者。

  • So it probably gives it to 3,300 to 3,500.

    因此,該數字可能達到 3,300 至 3,500。

  • And then I would, for supplement, take the average net revenue per patient we've been doing.

    然後,作為補充,我將計算我們每位患者的平均淨收入。

  • But don't forget, listen, you have to adjust the 2,500 starting point a little bit discontinuation.

    但別忘了,聽著,你必須稍微調整一下 2,500 的起點。

  • You don't get the full year benefit of those patients being on therapy.

    您無法獲得這些接受治療的病人全年的福利。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • And this ends our Q&A session for today.

    今天的問答環節到此結束。

  • I will turn it back to Greg for final comments.

    我將把這個意見交還給 Greg,請他發表最後的評論。

  • Gregory Divis - Chief Executive Officer

    Gregory Divis - Chief Executive Officer

  • Thank you.

    謝謝。

  • Just a few final comments to say first, thank you for spending your time and here on this afternoon.

    首先我想說幾句最後的話,感謝您今天下午抽出時間在這裡。

  • We look forward to any follow-ups -- and again, after the first number of quarters of launch, building our foundation, we do believe we are focused on the right things to both accelerate the demand and impact of persistency, and we look forward to providing those updates to you as we go forward.

    我們期待任何後續行動——並且,在發布的最初幾個季度之後,我們建立了基礎,我們確實相信我們專注於正確的事情,以加速持久性的需求和影響,我們期待在未來向您提供這些更新。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • Thanks.

    謝謝。

  • And with that, ladies and gentlemen, we conclude today's conference.

    女士們、先生們,今天的會議到此結束。

  • Thank you for participating, and you may now disconnect.

    感謝您的參與,您現在可以斷開連接。