Avadel Pharmaceuticals PLC (AVDL) 2022 Q4 法說會逐字稿

Greetings, and welcome to Avadel Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. Thank you. You may begin.

您好，歡迎參加 Avadel Pharmaceuticals 2022 年第四季度和全年收益電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。現在我很高興向斯特恩投資者關係部介紹奧斯汀·默塔。謝謝。你可以開始了。

Good morning, and thank you for joining us on our conference call, to discuss fourth quarter 2022 earnings. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones, or meet stringent regulatory requirements. Uncertainties regarding market entry and acceptance of products and the impact of competitive products and pricing.

早上好，感謝您參加我們的電話會議，討論 2022 年第四季度的收益。提醒一下，在我們開始之前，以下介紹包括構成 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述的若干事項。前瞻性陳述受到風險和不確定性的影響，可能導致實際結果與實際結果不同實質上來自於此類前瞻性陳述中設想的內容。這些風險包括開發階段的產品可能無法實現科學目標或里程碑，或滿足嚴格的監管要求的風險。市場准入和產品接受度的不確定性以及競爭產品和定價的影響。

These and other risks are described more fully in Avadel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2022, which was filed on March 29, 2023, and subsequent SEC filings. 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.

這些風險和其他風險在 Avadel 根據《交易法》提交的公開文件中得到了更全面的描述，該文件包含在截至 2022 年 12 月 31 日的年度 10-K 表格（於 2023 年 3 月 29 日提交）以及隨後向 SEC 提交的文件中。除法律要求外，Avadel 不承擔更新或修改本演示文稿中包含的任何前瞻性陳述以反映新信息、未來事件或其他情況的義務。

On the call today are Greg Divis, Chief Executive Officer; Jennifer Gudeman, Senior Vice President of Medical and Clinical Affairs; Richard Kim, Chief Commercial Officer; and Tom McHugh, Chief Financial Officer.

今天參加電話會議的是首席執行官格雷格·迪維斯 (Greg Divis)； Jennifer Gudeman，醫療和臨床事務高級副總裁；理查德·金，首席商務官；和首席財務官湯姆·麥克休。

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

這個時候，我會把電話轉給格雷格。

Thank you, Austin. Good morning, everyone, and thank you for joining us for a company update and to review our fourth quarter and full year 2022 results. 2023 is proving, as we expected to be a pivotal year for Avadel. We've already executed on a number of significant milestones, including the recent completion of multiple strategic financings that pave the way for growth and value creation as we enter the final stages to bring LUMRYZ, our investigational once-at-bedtime oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy to the market.

謝謝你，奧斯汀。大家早上好，感謝您接受我們的公司更新並回顧我們的第四季度和 2022 年全年業績。事實證明，2023 年將是 Avadel 的關鍵一年。我們已經實現了許多重要的里程碑，包括最近完成的多項戰略融資，為我們的增長和價值創造鋪平了道路，因為我們進入了 LUMRYZ（我們的研究性睡前一次羥丁療法）的最後階段。治療發作性睡病成人的猝倒或白天過度嗜睡的藥物上市。

With an oxybate eligible patient community of 30,000 to 35,000 strong and the opportunity to address the most important unmet need, which requires patients to forcibly awaken in the middle of the night during a precise 90-minute window. LUMRYZ offers the potential to provide oxybate patients the opportunity to have an uninterrupted night sleep, while commanding a meaningful share of the estimated $3 billion to $3.5 billion once-at-bedtime oxybate market.

擁有 30,000 至 35,000 名符合 oxybate 資格的患者社區，並有機會解決最重要的未滿足需求，這需要患者在半夜在精確的 90 分鐘窗口內強制醒來。 LUMRYZ 有潛力為氧丁藥物患者提供不間斷的夜間睡眠機會，同時在估計價值 30 億至 35 億美元的睡前一次氧丁藥物市場中佔據重要份額。

I am proud of all, that our team has recently accomplished, which has put us in a very strong position ahead of a potential final approval and the commercial launch of LUMRYZ. As announced yesterday, significant progress has been made in strengthening the company's balance sheet, providing us with the financial flexibility and a clean 10-K ahead of the potential launch of LUMRYZ, through the execution of a series of strategic financing which, in total, provides the company with approximately $200 million of committed capital to support a potential LUMRYZ launch, and a new April 2027 maturity date for $96.2 million of our convertible notes.

我為我們團隊最近所取得的成就感到自豪，這使我們在 LUMRYZ 潛在的最終批准和商業發布之前處於非常有利的地位。正如昨天所宣布的，通過執行一系列戰略融資，在加強公司資產負債表方面取得了重大進展，為我們提供了財務靈活性，並在 LUMRYZ 可能推出之前提供了乾淨的 10-K，這些融資總共：為該公司提供約 2 億美元的承諾資本，以支持潛在的 LUMRYZ 發行，並將 9620 萬美元的可轉換票據定為 2027 年 4 月新的到期日。

The total capital includes $125 million from an equity raise and up to an additional $75 million in royalty financing with RTW Investments. RTW, our largest equity holder, continues to be incredibly supportive of Avadel and LUMRYZ and this additional royalty financing, along with the convert exchange and equity raise provides us with the necessary resources and balance sheet to fully support the commercialization of LUMRYZ for people living with narcolepsy.

總資本包括 1.25 億美元的股權融資以及 RTW Investments 提供的最多 7500 萬美元的特許權使用費融資。我們最大的股東 RTW 繼續大力支持 Avadel 和 LUMRYZ，這種額外的特許權使用費融資以及轉換交換和股權融資為我們提供了必要的資源和資產負債表，以全力支持 LUMRYZ 為患有以下疾病的人們實現商業化：發作性睡病。

Tom will provide further details, a little later in this call, but it is important to state emphatically that the completion of these financing actions puts us in a strong financial position to execute on our launch priorities and deliver on our mission to transform Avadel into a commercial organization, and a major player in the narcolepsy space.

Tom 將在本次電話會議稍後提供更多詳細信息，但重要的是要強調，這些融資行動的完成使我們處於強大的財務狀況，可以執行我們的發布優先事項並實現我們將 Avadel 轉變為商業組織，也是嗜睡症領域的主要參與者。

I want to thank everyone, and especially all of our investors, who have supported us during this process and your continued belief in the promise and future of Avadel and LUMRYZ. Turning to our progress on the regulatory front. Earlier this month, we submitted a minor amendment to our LUMRYZ NDA, requesting final FDA approval. This came shortly after the REMS patent was delisted from the FDA's Orange Book in response to the unanimous 3 to 0 panel decision of the United States Court of Appeals for the Federal Circuit on February 24, affirming the previous District Court ruling, ordering that delisting.

我要感謝在此過程中支持我們的所有人，特別是所有投資者，以及你們對 Avadel 和 LUMRYZ 的承諾和未來的持續信念。轉向我們在監管方面的進展。本月早些時候，我們提交了 LUMRYZ NDA 的小修改，請求 FDA 最終批准。在此之前不久，REMS 專利被從 FDA 橙皮書中除名，以回應美國聯邦巡迴上訴法院 2 月 24 日以 3 比 0 的一致裁決，維持了地區法院先前的裁決，下令將其除名。

Based on recent interactions with the FDA, and the March 1 submission date for our minor amendment requesting final approval. FDA guidance to us would suggest timing to a decision could be around 2 months or approximately early May. Please note, actual timing is not in our control. However, we remain committed to continuing to do all we can to try to accelerate this. If or when, we learn anything more specific, we will certainly share that information as appropriate. We also recently announced that the FDA approved our Pre-Launch Activities Importation Request or PLAIR for LUMRYZ. This has allowed us to import LUMRYZ into the U.S. ahead of a final approval decision and puts us in a position to potentially shorten the time to product availability. With this, we expect to be in a position to have LUMRYZ available in about 4 weeks, after a potential final approval.

根據最近與 FDA 的互動，以及我們請求最終批准的小修改的 3 月 1 日提交日期。 FDA 向我們提供的指導建議，做出決定的時間可能是 2 個月左右或大約 5 月初。請注意，實際時間不受我們控制。然而，我們仍然致力於繼續盡一切努力加速這一進程。如果或當我們了解到任何更具體的信息時，我們一定會酌情分享該信息。我們最近還宣布 FDA 批准了我們的 LUMRYZ 啟動前活動進口請求或 PLAIR。這使我們能夠在最終批准決定之前將 LUMRYZ 進口到美國，並有可能縮短產品上市的時間。有了這個，我們預計在獲得最終批准後大約 4 週內即可推出 LUMRYZ。

With the near-term final approval decision and the potential for product availability shortly thereafter, we have been focused on building and preparing our organization for the potential launch of LUMRYZ. Richard will join us shortly to provide a further update on our launch preparations and progress.

鑑於近期的最終批准決定以及此後不久產品上市的可能性，我們一直專注於為 LUMRYZ 的潛在推出建立和準備我們的組織。理查德很快就會加入我們，提供有關我們的發射準備和進展的進一步更新。

And lastly, and certainly not least, we continue to expand the patent exclusivity for LUMRYZ. As we've recently been granted 5 additional U.S. patents for a current total of 13. These 13 U.S. patents provide Orange Book listable patent protection into early 2042 with many more applications pending at the U.S. patent office. We have a lot to cover today.

最後，同樣重要的是，我們繼續擴大 LUMRYZ 的專利獨占權。我們最近又獲得了 5 項美國專利，目前總數為 13 項。這 13 項美國專利在 2042 年初提供橙皮書列出的專利保護，還有更多申請正在美國專利局等待處理。今天我們有很多內容要講。

So with that, I'll turn the call over to Jennifer for details on our recent scientific data presentations. Jennifer?

因此，我將把電話轉給詹妮弗，了解我們最近的科學數據演示的詳細信息。詹妮弗？

Thanks, Greg, and good morning. It's an exciting time for us. We closed out last year by presenting a total of 7 posters between the American Neurological Association and the test meeting. I will briefly highlight 2 of the posters. First, a real-world study with the Mayo Clinic to understand the top 20 comorbidities increased in people with narcolepsy compared to a matched cohort. The top 20 did not include cardiovascular disease. And second, a discrete choice experiment where among 100 clinicians and 125 patients the most important driver of oxybate treatment choice with a single dose.

謝謝，格雷格，早上好。這對我們來說是一個激動人心的時刻。去年，我們在美國神經病學協會和測試會議之間總共展示了 7 張海報。我將簡要介紹其中兩張海報。首先，與 Mayo Clinic 合作進行了一項真實世界研究，旨在了解與匹配隊列相比，發作性睡病患者增加的前 20 種合併症。前20名中不包括心血管疾病。其次，是一項離散選擇實驗，其中 100 名臨床醫生和 125 名患者選擇了單劑量羥丁治療的最重要驅動因素。

Whether it is medical congresses or individual KOL meetings, our experience in FL team are having, we consistently see unsolicited excitement and enthusiasm for the unmet need that LUMRYZ will fulfill, if approved. The robust clinical study data of LUMRYZ and the clinical value proposition of avoiding middle of the night dosing is well understood. Regarding the benefit of eliminating the middle of the night dose, we supported research that was conducted by trend community to better understand the patient experience with twice-nightly oxybate. Trend community submitted these data, which were accepted as a late-breaking abstract to the advances in Sleep and Circadian Science Meeting held in February. I will share a few highlights (inaudible) presented from their sample of 85 respondents with narcolepsy who have currently or previously taken twice-nightly oxybate therapies. Approximately 75% of the patients surveyed reported missing the second dose.

無論是醫學大會還是個人 KOL 會議，根據我們在 FL 團隊的經驗，我們始終看到人們對未滿足的需求感到興奮和熱情，如果獲得批准，LUMRYZ 將滿足這些需求。 LUMRYZ 穩健的臨床研究數據和避免半夜給藥的臨床價值主張是眾所周知的。關於消除半夜服藥的好處，我們支持趨勢社區進行的研究，以更好地了解患者每晚服用兩次羥丁的體驗。趨勢社區提交了這些數據，這些數據被接受為二月份舉行的睡眠和晝夜節律科學會議的最新進展摘要。我將分享他們的 85 名發作性睡病受訪者樣本中的一些亮點（聽不清），這些受訪者目前或之前接受過每晚兩次羥丁療法。大約 75% 的接受調查患者報告錯過了第二劑。

Of that group, 65% shared, if this happens at least monthly. Further, 32% reported suffering injuries when waiting to take a second dose of therapy. Of that group, 1/3 said this occurs at least monthly. These new TRIM data, which are consistent with what we have learned in our RESTORE study, via patients switching from twice-nightly highlight the potential positive impact that once-nightly dosing will have on people living with narcolepsy.

在該群體中，65% 的人分享了這一點（如果這種情況至少每月發生一次）。此外，32% 的人報告在等待接受第二劑治療時受傷。在該群體中，1/3 的人表示這種情況至少每月發生一次。這些新的 TRIM 數據與我們在 RESTORE 研究中了解到的一致，通過患者從每晚兩次給藥的轉變，強調每晚一次給藥將對發作性睡病患者產生潛在的積極影響。

Let's turn now to the published data reporting additional safety concerns with currently available treatment regimens. In January, we published our findings in the Journal drug real-world outcomes from the FDA Adverse Event Reporting system or FAERS, of reports that showed patients are inadvertently taking their second dose of sodium oxybate, less than 2.5 hours after their first. Which can be associated with serious adverse events. It's relevant to consider what prompted this research. We have heard time and time again from people taking twice-nightly oxybate that this happens. And when it does, it can be a heroing experience as the publication underscores. The other consistent theme we hear is that, patients don't report this to their doctors, the FDA or the rooms program because they are fearful if they did that their therapy would no longer be accessible.

現在讓我們看一下已發表的數據，報告了當前可用治療方案的額外安全問題。一月份，我們在《雜誌》上發表了 FDA 不良事件報告系統 (FAERS) 藥物真實世界結果的研究結果，報告顯示患者在服用第一劑後不到 2.5 小時無意中服用了第二劑羥丁酸鈉。這可能與嚴重的不良事件有關。考慮是什麼促使了這項研究是相關的。我們一次又一次地從每晚服用兩次羥丁酯的人那裡聽到這種情況發生。當它發生時，正如該出版物所強調的那樣，這可能是一次英雄經歷。我們聽到的另一個一致的主題是，患者不會向他們的醫生、FDA 或房間計劃報告這一情況，因為他們擔心如果他們這樣做，他們的治療將不再可用。

It's well recognized that Adverse Event Reporting is the tip of the iceberg, reporting it voluntary for both patients and health care providers, and it is estimated that only about 10% of adverse events are reported. Without any other option, the reticence of patients to share these safety concerns and have clinicians to ask about potential safety concerns, is not surprising. Yet the risks are relevant. Among this sample, 27% of reports where dosing was less than 2.5 hours after the first resulted in hospitalization with another 22% associated with the use of emergency services.

眾所周知，不良事件報告只是冰山一角，患者和醫療保健提供者都自願報告，但據估計，只有約 10% 的不良事件被報告。在沒有任何其他選擇的情況下，患者不願分享這些安全問題並讓臨床醫生詢問潛在的安全問題，這並不奇怪。然而風險是相關的。在該樣本中，27% 的報告在第一次給藥後不到 2.5 小時導致住院，另外 22% 的報告與使用緊急服務有關。

We look forward to providing a treatment option, we believe will mitigate this serious safety risk of taking a CNS depressant earlier than is advisable, as well as overcoming the challenges of missing the second dose and/or taking it too late.

我們期待提供一種治療方案，我們相信這將減輕提前服用中樞神經系統抑製劑的嚴重安全風險，並克服錯過第二劑和/或服用太晚的挑戰。

I will now turn the call over to Richard to provide an update on the commercial opportunity and Avadel's preparations for launch. Richard?

我現在將把電話轉給 Richard，以提供有關商業機會和 Avadel 的發布準備工作的最新信息。理查德？

Thanks, Jennifer, and good morning, everyone. The great progress that Greg covered has allowed us to finalize our pre-commercialization activities. And today, I will share some additional market research that continues to support why we believe LUMRYZ can have a major impact in the narcolepsy market. In addition, I will provide further updates on our significant launch readiness progress. With the submission of the amendment for LUMRYZ to the FDA, the imminent decision for final approval and rapidly approaching potential product availability, our commercial rate (inaudible) have progressed as we continue to progress to bring once-at-bedtime [minimize] to the north of the community. We have been working diligently over the past few months ensuring (inaudible) to drug availability following potential final approval, and this was further confirmed with the FDA recently granted our PLAIR.

謝謝，詹妮弗，大家早上好。格雷格報導的巨大進展使我們能夠完成我們的預商業化活動。今天，我將分享一些額外的市場研究，這些研究繼續支持為什麼我們相信 LUMRYZ 可以對嗜睡症市場產生重大影響。此外，我將提供有關我們重大發射準備進展的進一步更新。隨著向 FDA 提交 LUMRYZ 修正案、即將做出最終批准決定以及迅速接近潛在產品可用性，我們的商業化率（聽不清）已經取得進展，因為我們繼續努力將睡前一次[最小化]社區北邊。在過去的幾個月裡，我們一直在努力確保（聽不清）潛在的最終批准後藥物的可用性，FDA 最近授予我們的 PLAIR 進一步證實了這一點。

In this regard, we currently expect depending on the potential final approval timing to have product available in the market in approximately 4 weeks post approval. Now in addition to the PLAIR approval, we've made significant progress with our REMS and patient services center, which will both be operational in advance of a final approval and our supply distribution network, which will be fully operational when the product is available. Earlier this year, we performed new market research, which included a sleep specialists with varying amounts of oxybate utilization. Here's a few key takeaways. First, when shown the LUMRYZ product profile, sleep specialists give LUMRYZ the highest oxybate market share. Now receiving the highest overall market share from this research is horribly consistent with 3 previous demand studies we have conducted. Representing insights from hundreds of these specialists. Supporting this, with the vast majority of sleep specialists stated that they were either likely or highly likely to prescribe LUMRYZ. Second, with the introduction of LUMRYZ over time, oxybate usage of narcolepsy patients is expected to grow by at least 50%. This is very consistent with previous research, where with the introduction of once-at-bedtime LUMRYZ, sleep specialty more of their patients becoming eligible and being treated with oxybate therapy. And third, sleep specialty utilization for LUMRYZ coming from switch patients currently taking twice-nightly oxybate, as well as those who are unable to stay on twice-nightly therapy. Further, our research suggests LUMRYZ will become the first choice oxybate for previously untreated oxybate eligible patients.

在這方面，我們目前預計，根據潛在的最終批准時間，產品將在批准後大約 4 週內上市。現在，除了 PLAIR 的批准外，我們的 REMS 和患者服務中心也取得了重大進展，這些中心將在最終批准之前投入運營，我們的供應分銷網絡也將在產品上市後全面投入運營。今年早些時候，我們進行了新的市場研究，其中包括睡眠專家的不同羥丁酸利用率。以下是一些要點。首先，當顯示 LUMRYZ 產品簡介時，睡眠專家給予 LUMRYZ 最高的羥丁酸酯市場份額。現在，從這項研究中獲得最高的總體市場份額與我們之前進行的 3 項需求研究驚人地一致。代表了數百位專家的見解。支持這一點的是，絕大多數睡眠專家表示他們很可能或極有可能開 LUMRYZ 處方。其次，隨著 LUMRYZ 的推出，預計發作性睡病患者的羥丁酯使用量將增加至少 50%。這與之前的研究非常一致，隨著睡前一次 LUMRYZ（睡眠專業）的推出，更多的患者符合資格並接受羥丁療法治療。第三，LUMRYZ 的睡眠專業用途來自目前每晚兩次 oxybate 的轉換患者，以及無法繼續每晚兩次治療的患者。此外，我們的研究表明，LUMRYZ 將成為以前未接受過羥丁治療的合格患者的首選羥丁藥物。

We continue to see the consistency from our market research about the impact that LUMRYZ can have, in addressing the unmet need for people with narcolepsy and the significant interest from sleep specialists that can make LUMRYZ the preferred treatment in a growing oxybate narcolepsy market.

我們繼續從我們的市場研究中看到，LUMRYZ 在解決發作性睡病患者未滿足的需求方面可以產生的影響是一致的，而且睡眠專家的濃厚興趣可以使 LUMRYZ 成為不斷增長的羥丁酸酯發作性睡病市場的首選治療方法。

Now I'll provide an update on our readiness efforts, as we have significantly expanded the scope of our execution against our launch plans. First, we have packaged a significant amount of commercial supply for LUMRYZ in its primary daily packets. For product fulfillment, we have completed the REMS programming and along with our patient services center, both teams have been actively ramping up their hiring and should be fully staffed in the next couple of weeks. We've also signed contracts with our full specialty pharmacy network. On the payer front, our team had several key meetings with decision-makers at the GPOs and PBMs that manage over 85% of the commercially insured lives.

現在，我將提供有關我們準備工作的最新信息，因為我們已根據啟動計劃顯著擴大了執行範圍。首先，我們在其主要日常包裝中包裝了大量的 LUMRYZ 商業供應。為了實現產品，我們已經完成了 REMS 編程，並且與我們的患者服務中心一起，兩個團隊都在積極增加招聘，並且應該在接下來的幾週內配備滿人員。我們還與我們完整的專業藥房網絡簽訂了合同。在付款人方面，我們的團隊與 GPO 和 PBM 的決策者舉行了幾次重要會議，這些機構管理著超過 85% 的商業保險人壽。

With the favorable decision in the Federal Court, this REMS patent delisting and our REMS, our LUMRYZ amendment submitted, our conversation with payers have accelerated around contracts and coverage for LUMRYZ and the feedback continues to be positive. We've also been focusing on building an exceptional team to support LUMRYZ. We have hired, the majority of noncustomer-facing roles across the team and have made offers to the majority of our territory business managers or sales representatives and our field reimbursement team for them to start in the next couple of weeks. For our sales team, we have prioritized hiring people with rare disease experience, previous least experienced or experience with our target prescriber base. As well as their ability to deliver in highly competitive markets.

隨著聯邦法院做出有利的決定、此 REMS 專利退市以及我們的 REMS、我們提交的 LUMRYZ 修正案，我們與付款人圍繞 LUMRYZ 的合同和承保範圍的對話加快了，並且反饋仍然是積極的。我們還一直致力於打造一支出色的團隊來支持 LUMRYZ。我們已經僱傭了團隊中的大多數非面向客戶的角色，並向我們的大多數地區業務經理或銷售代表以及我們的現場報銷團隊提出了在未來幾週內開始工作的邀請。對於我們的銷售團隊，我們優先僱用具有罕見疾病經驗、以前經驗最少或與我們的目標處方者群體有經驗的人員。以及他們在競爭激烈的市場中提供服務的能力。

Now of course, like the rest of our team, being aligned to our core value and always putting patients first is a must. The energy and excitement from our current Avadel team and our new colleagues joining us is helpful. And our goal is to ensure everyone on our team is singularly focused on how to improve the lives of people with narcolepsy. We look forward to providing more updates on future calls.

當然，現在，像我們團隊的其他成員一樣，必須與我們的核心價值觀保持一致並始終將患者放在第一位。我們當前的 Avadel 團隊和加入我們的新同事所帶來的活力和興奮是有幫助的。我們的目標是確保團隊中的每個人都專注於如何改善嗜睡症患者的生活。我們期待在未來的通話中提供更多更新。

And with that, I will now turn the call over to Tom for an update on the company's financials. Tom?

現在，我將把電話轉給湯姆，詢問公司財務狀況的最新情況。湯姆？

Thank you, Richard. I'll note that full financial results are available in the press release and the 10-K. And details of our recently completed financing transactions during the 8-Ks we filed. I'll start with comments about our recent financing announcements. I am pleased to report that we executed the financial strategy that we've been communicating for the past several months and accomplished 2 critical goals: one, secured $200 million of funding for the anticipated launch of LUMRYZ in the form of committed capital from a $75 million royalty financing, and immediately available capital from $125 million equity offering. Two, we addressed the maturity of the convertible notes, which strengthened our balance sheet and provides financial flexibility to focus on our launch priorities.

謝謝你，理查德。我要指出的是，完整的財務業績可在新聞稿和 10-K 中找到。以及我們最近在 8-K 期間完成的融資交易的詳細信息。我將首先評論我們最近的融資公告。我很高興地向大家報告，我們執行了過去幾個月一直在溝通的財務戰略，並實現了 2 個關鍵目標：第一，以 75 美元的承諾資本形式為 LUMRYZ 的預期推出獲得 2 億美元的資金。百萬特許權使用費融資，以及可立即從 1.25 億美元股票發行中獲得的資金。第二，我們解決了可轉換票據的到期問題，這增強了我們的資產負債表，並提供了財務靈活性，以專注於我們的推出優先事項。

Our financing strategy consists of 3 major components: first, we completed an exchange of $96.2 million of the convertible notes and importantly, extended the maturity out to April 2027. This eliminates what would have potentially been a significant use of cash later this year, and moving this debt to a long-term obligation significantly improves our balance sheet and financial flexibility. Second, we secured committed capital in the form of a $75 million royalty financing from RTW Investments. The funding will be available to Avadel in 2 tranches of $30 million and $45 million, upon meeting certain regulatory and financial milestones, and we expect the first tranche will be available following the launch of LUMRYZ.

我們的融資策略由 3 個主要組成部分組成：首先，我們完成了 9620 萬美元的可轉換票據交換，重要的是，將到期日延長至 2027 年 4 月。這消除了今年晚些時候可能大量使用現金的情況，並且將這筆債務轉為長期債務可顯著改善我們的資產負債表和財務靈活性。其次，我們從 RTW Investments 獲得了 7500 萬美元特許權使用費融資的承諾資本。在達到某些監管和財務里程碑後，Avadel 將分兩期獲得資金，金額分別為 3000 萬美元和 4500 萬美元，我們預計第一期資金將在 LUMRYZ 推出後提供。

The second tranche of $45 million is available to draw at our option, upon achieving a revenue milestone should we choose to do so. This component of our strategy provides us with the security of a future funding commitment and with favorable terms, such as a royalty rate of 3.75% and lack of financial covenants. We sincerely appreciate the support of RTW and the confidence they placed in Avadel to deliver the value we believe, LUMRYZ promises. Third, we completed an equity raise, which generated gross proceeds of $125 million. This component of our financing strategy provides the immediate capital needed to fund the launch of LUMRYZ. The significant support that our shareholders demonstrated through their participation in the equity offering speaks to the confidence they have and the potential value of LUMRYZ.

如果我們選擇在實現收入里程碑後，我們可以選擇提取第二筆 4500 萬美元。我們戰略的這一組成部分為我們提供了未來資金承諾的保障和有利的條款，例如 3.75% 的特許權使用費率和缺乏財務契約。我們衷心感謝 RTW 的支持以及他們對 Avadel 的信任，以實現我們相信的 LUMRYZ 承諾的價值。第三，我們完成了股權融資，募集資金總額達 1.25 億美元。我們融資策略的這一部分提供了啟動 LUMRYZ 所需的直接資金。我們的股東通過參與股票發行所表現出的大力支持表明了他們的信心和 LUMRYZ 的潛在價值。

As I previously stated, we are pleased with the results of our financing strategy, the faith investors have placed in the company and their confidence in the opportunity that lies in pet for LUMRYZ. On a final note, we reported $96.5 million of cash, cash equivalents and marketable securities as of December 31, 2022. For additional detail on our 2022 financial results, please refer to the press release issued earlier this morning, or the 10-K filed yesterday.

正如我之前所說，我們對融資策略的結果、投資者對公司的信心以及對 LUMRYZ 所擁有的機會的信心感到滿意。最後一點，截至 2022 年 12 月 31 日，我們報告了 9650 萬美元的現金、現金等價物和有價證券。有關我們 2022 年財務業績的更多詳細信息，請參閱今天上午發布的新聞稿，或提交的 10-K 報告昨天。

The combination of cash on hand, the maturity extension of the convertible notes and the capital we secured, allowed us to file a clean 10-K with a strong balance sheet. The actions we took last year resulted in closing out 2022 with over $95 million of cash and that, in addition to the financing stretch we completed puts the company in a strong financial position, as we get ready for our anticipated launch of LUMRYZ.

手頭現金、可轉換票據的期限延長以及我們獲得的資本的結合，使我們能夠提交一份乾淨的 10-K 報表，並擁有強大的資產負債表。我們去年採取的行動為 2022 年帶來了超過 9500 萬美元的現金，除了我們完成的融資之外，在我們為預期推出的 LUMRYZ 做好準備的同時，還使公司處於強大的財務狀況。

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

現在我將把電話轉回給格雷格，讓他作結束語。

Thank you, Tom. From where we sit today, we are operating from a position of strength across our organization, on the cusp of a pivotal moment for the company as we transition to a commercial company poised for significant growth and rapidly approach the opportunity to make a meaningful and positive impact for patients in the narcolepsy community at large. The significant milestones we have recently achieved, including submitting our amendment to the LUMRYZ NDA along with executing multiple strategic financings, are critical steps toward our mission. Built on the foundation of a clear value proposition of [Bloom Rise], which has been recognized by our Chief stakeholders, including patients, sleep specialists and shareholders.

謝謝你，湯姆。從我們今天的位置來看，我們在整個組織中處於優勢地位，正處於公司的關鍵時刻，因為我們正在轉型為一家準備顯著增長的商業公司，並迅速抓住機遇，創造有意義和積極的成果對整個發作性睡病社區患者的影響。我們最近實現的重要里程碑，包括提交 LUMRYZ NDA 修正案以及執行多項戰略融資，是實現我們使命的關鍵步驟。建立在 [Bloom Rise] 明確的價值主張的基礎上，該價值主張得到了我們的主要利益相關者（包括患者、睡眠專家和股東）的認可。

With the work our team has done over the past few months from a legal, regulatory, financial and organizational readiness perspective, we are in an excellent position to take our next step to bring LUMRYZ to the narcolepsy community. We are ready to deliver on the promise of LUMRYZ to transform the market and the lives of people with Narcolepsy. We thank you for your support. We look forward to providing future updates on our progress.

通過我們團隊在過去幾個月從法律、監管、財務和組織準備角度所做的工作，我們處於有利的位置，可以採取下一步行動，將 LUMRYZ 引入嗜睡症社區。我們已準備好兌現 LUMRYZ 的承諾，改變市場和嗜睡症患者的生活。我們感謝你的支持。我們期待在未來提供有關我們進展的最新信息。

And with that, operator, we'll open up the call for questions.

接線員，我們將開始提問。

(Operator Instructions) Our first question comes from the line of Chris Howerton with Jefferies.

（操作員說明）我們的第一個問題來自 Chris Howerton 和 Jefferies 的電話。

Great. I just wanted to offer my congratulations on all the financing and the updates. I guess two questions from me. One would be in terms of kind of the pricing strategy that you're expecting to use. Maybe you could give us a little more color on kind of how you're considering pricing of LUMRYZ, in this market and maybe is a little corollary there in those discussions, do the payers have the generic twice-nightly oxybate on their radar as part of that discussion. And then the second one would be just kind of are you anticipating a bolus of launch a bolus of patients expecting to get on LUMRYZ at launch or should this be more of a gradual thing?

偉大的。我只是想對所有融資和更新表示祝賀。我想我有兩個問題。其中之一是您期望使用的定價策略類型。也許你可以給我們更多關於你如何考慮 LUMRYZ 定價的信息，在這個市場上，也許在這些討論中會有一些推論，付款人是否將通用的每晚兩次 oxybate 作為其雷達的一部分那個討論。那麼第二個問題就是，您是否預計會在上市時大量推出 LUMRYZ 的患者，或者這應該是一個循序漸進的事情？

Yes. Thanks, Chris. Richard, maybe you can start with the pricing and commentary and then certainly, I can comment on the -- how we're thinking about forecast.

是的。謝謝，克里斯。理查德，也許你可以從定價和評論開始，然後當然，我可以評論我們如何考慮預測。

Yes, sure. Thanks for the question, Chris. So yes, as far as our pricing is concerned, I mean, our overall strategy based on the value proposition of LUMRYZ has been we're going to win with patients, win with providers, and in essence, really a draw with payers really more from a parity perspective. So, we've been very consistent in our messaging that our target price for LUMRYZ is going to be more in the parity range with the branded oxybate. And as far as the AGs are concerned, yes, we've definitely had a chance to speak to all the payers, thus far. And I think, the general feedback on the AG is, it is being treated like the brand extension. It is from what we see now, it is beginning to get coverage, but we haven't seen any movement or force movement from a branded twice-nightly oxybate to the AG at this stage. So we have built our whole strategy knowing that the AG will be in the marketplace. So the fact that it's here is really very much in line with our plans. And so far, our conversations with the payers have been really, really positive as well. So -- and Greg, I'll pass the next question to you.

是的，當然。謝謝你的提問，克里斯。所以，是的，就我們的定價而言，我的意思是，我們基於 LUMRYZ 價值主張的總體策略是，我們將贏得患者、贏得提供商，從本質上講，真正吸引付款人從平價的角度來看。因此，我們的信息一直非常一致，即 LUMRYZ 的目標價格將與品牌 oxybate 處於同等範圍內。就 AG 而言，是的，到目前為止，我們肯定有機會與所有付款人交談。我認為，對 AG 的普遍反饋是，它被視為品牌延伸。從我們現在看到的情況來看，它已經開始得到報導，但現階段我們還沒有看到從品牌的每晚兩次羥丁到 AG 的任何運動或力量運動。因此，我們知道 AG 將進入市場，因此制定了整個戰略。所以它的出現確實非常符合我們的計劃。到目前為止，我們與付款人的對話也非常非常積極。那麼，格雷格，我將把下一個問題交給你。

Yes. I think, Chris, as it relates to how we think about the early months of launch, we certainly don't intend to guide with any specificity from that standpoint. We'll talk more about, how we think the market opportunity is and what that looks like, as we get through the next number of milestones from an approval and leaning into a launch. But, I think at the end of the day, the team has done a great job to think through all the potential things that happened early on, in kind of ordinary course of product launches from reimbursement to transition into patient services center to securing coverage and whatnot. So we're putting in all the necessary capabilities to be able to address those things, and we're pleased with the progress we've made and the feedback we're getting, both across the patient community, physician community and payer community.

是的。我認為，克里斯，因為這關係到我們如何看待發布的最初幾個月，我們當然不打算從這個角度提供任何具體指導。當我們經歷從批准到發布的接下來的一些里程碑時，我們將更多地討論我們如何看待市場機會以及它是什麼樣的。但是，我認為歸根結底，該團隊已經出色地思考了早期發生的所有潛在問題，就像產品發布的正常過程一樣，從報銷到過渡到患者服務中心，再到確保覆蓋範圍和諸如此類的。因此，我們正在投入所有必要的能力來解決這些問題，我們對患者社區、醫生社區和付款人社區所取得的進展和收到的反饋感到滿意。

Our next question comes from the line of Adam Evertts with LifeSci Capital.

我們的下一個問題來自 LifeSci Capital 的 Adam Evertts。

Great. Congrats on all the great news this quarter, as well as strengthening the balance sheet. So, I just wanted to ask -- make sure I'm clear on what will be in place at the time of full approval, assuming that occurs in early May. I mean it sounds like the commercial team, including the sales force will be ready, product will be available roughly 4 weeks later. And then just remind me, I think, Richard maybe said it on the REMS program that will also be in place by approval or certainly by launch?

偉大的。祝賀本季度所有好消息以及加強資產負債表。所以，我只是想問——確保我清楚在完全批准時將採取什麼措施，假設發生在五月初。我的意思是，聽起來商業團隊（包括銷售人員）已經準備就緒，產品將在大約 4 週後上市。然後提醒我，我想，理查德可能在 REMS 計劃上說過，該計劃也將通過批准或肯定通過啟動而實施？

Yes. Thanks, Adam. Richard, do you want to comment on that?

是的。謝謝，亞當。理查德，你想對此發表評論嗎？

Yes. Adam. Thanks for the question today. So yes, we -- as far as our operational perspective, as far as REMS distribution, where we -- the REMS is, in essence, that programming is done. We'll be higher fully staffed for both our REMS program and our patient services center within the next couple of weeks. So that first phase, we're ready. We could be focus switch in just a couple of weeks here as well. To your point, as Greg had mentioned, supply should be available approximately 4 weeks after a final approval, and our team is coming on board as well. So we are ready to be able to deliver this. And yes, so all of our key components are ready to go in the next couple of weeks.

是的。亞當。謝謝你今天的提問。所以，是的，我們——就我們的運營角度而言，就 REMS 分佈而言，我們——REMS 本質上是編程已經完成。在接下來的幾週內，我們將為我們的 REMS 計劃和患者服務中心配備更多的人員。所以第一階段，我們已經準備好了。我們也可能在短短幾週內就轉移焦點。就您的觀點而言，正如格雷格所提到的，供應應該在最終批准後大約 4 週內提供，我們的團隊也將加入。所以我們已經準備好能夠實現這一目標。是的，我們所有的關鍵組件都已準備好在接下來的幾週內投入使用。

Fantastic. And then, one quick one for Tom. Tom, you mentioned the second tranche on the royalty side. That was triggered by a regulatory milestone or a sales milestone?

極好的。然後，給湯姆一個快速的。湯姆，你提到了版稅方面的第二部分。這是由監管里程碑還是銷售里程碑觸發的？

The second tranche of $45 million is on a quarterly revenue milestones.

第二筆 4500 萬美元是季度收入里程碑。

Our next question comes from the line of François Brisebois with Oppenheimer.

我們的下一個問題來自弗朗索瓦·布里斯布瓦和奧本海默的關係。

This is Dan Tongon on for Frank. Congrats on all the progress. Just a quick one for me. In terms of the payer discussions, just wondering how useful or important are these real-world outcome studies that you've been doing? And is this coming up in these payer discussions from a payer's perspective in terms of reimbursement?

我是丹·湯貢（Dan Tongon）代表弗蘭克（Frank）發言。祝賀所有的進展。對我來說只是一個快速的。就付款人討論而言，只是想知道您一直在進行的這些現實世界結果研究有多有用或重要？從付款人的角度來看，這些付款人討論中是否會出現這種情況？

Richard, do you want to go or.

理查德，你想去還是。

Yes, sure. Dan, thanks for the question. So, I think the really great thing is with the recent regulatory and legal events have come on, the payer engagement has definitely stepped up to that next level, overall here as well. And I think holistically, the good news is we're really focusing on really strengthening the conversations around the clinical value proposition. So the team has been doing clinical presentations. And, I think going forward, I mean the payers are always interested in real-world evidence. So those questions do come up, and I think we plan on sharing more of that as more of the data can -- could be published as well. So overall, the conversation has definitely been a lot more shifted towards the clinical value proposition of LUMRYZ.

是的，當然。丹，謝謝你的提問。因此，我認為真正偉大的事情是，隨著最近的監管和法律事件的發生，付款人的參與度肯定上升到了一個新的水平，總體而言也是如此。我認為從整體上看，好消息是我們真正專注於加強圍繞臨床價值主張的對話。所以團隊一直在做臨床演示。而且，我認為展望未來，付款人總是對現實世界的證據感興趣。所以這些問題確實出現了，我認為我們計劃分享更多的問題，因為更多的數據也可以發布。因此，總的來說，話題肯定更多地轉向了 LUMRYZ 的臨床價值主張。

Great. And just a quick one. I believe, you already talked about it, just to be clear. In terms of the REMS build-out, -- so at this point, is the -- on the technology infrastructure standpoint, is that already completed and now staffing is the next thing?

偉大的。只是一個快速的。我相信，您已經說過了，只是為了清楚起見。就 REMS 建設而言，從技術基礎設施的角度來看，目前是否已經完成，現在下一步是人員配備嗎？

In short, Dan, that's exactly correct. And staffing is ongoing now. So, as Richard noted, it was in a matter of just a couple of weeks, that will be fully operational. And Jen, I know this goes under your purview. So if you have any comments you want to add, please do.

簡而言之，丹，這是完全正確的。目前，人員配置工作正在進行中。因此，正如理查德指出的那樣，只需幾週時間，該項目就將全面投入運營。 Jen，我知道這屬於你的職權範圍。因此，如果您有任何想要添加的意見，請添加。

You described it perfectly. So programming is complete. The staffing is taking place right now, and we're just a few short weeks away, from being ready to go.

你描述得很完美。這樣編程就完成了。人員配置工作正在進行中，距離準備就緒只有短短幾週的時間。

Our next question comes from David Amsellem with Piper Sandler.

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

So I just had a couple. You talked through the challenges with middle of the night dosing. But I wanted to get your thoughts on potential counter-detailing messages from your competitor. Things that we've heard anecdotally from KOLs like taking LUMRYZ too late at night, intensity interference performing functionality or even bedwetting. So how do you respond to that kind -- those kinds of concerns. And particularly, as it relates to competition and messaging, what is your counter those kinds of concerns. So I'll stop there.

所以我只吃了幾個。您談到了半夜給藥所面臨的挑戰。但我想了解您對競爭對手潛在的反細節信息的看法。我們從 KOL 那裡聽到過一些軼事，比如深夜服用 LUMRYZ、強度干擾功能甚至尿床。那麼你如何回應這種擔憂。特別是，因為它與競爭和信息傳遞有關，你會如何應對這些擔憂。所以我就到此為止。

Yes. Thanks, David. Jen, I'll let you go first.

是的。謝謝，大衛。珍，我先放你走。

Sure, that's great. We have conducted 2 relative bioavailability studies covering LUMRYZ to twice-nightly sodium oxybate. And what we have shown is that our concentration, 8 hours after taking the dose is actually a little bit lower than twice-nightly sodium oxybate. So based upon those blood levels, there would not be any sort of expectation of impairment the next day. And that certainly is not something we've seen in our pivotal clinical trial or in our open-label study. I think, it's also really, really important to note that within the oxybate, you shouldn't drive or operate heavy machinery 6 hours after taking the dose. When you think about LUMRYZ, that covers the nocturnal sleep period. When you think about twice-nightly and that 90-minute window, when you can take your second dose, when patients are waking up later, that is a restriction with that additional 6 hours that oftentimes does interfere with next-day functioning.

當然，那太好了。我們進行了 2 項相對生物利用度研究，涵蓋 LUMRYZ 與每晚兩次羥丁酸鈉的比較。我們已經證明，服藥 8 小時後，我們的濃度實際上比每晚兩次的羥丁酸鈉要低一些。因此，根據這些血液水平，第二天不會有任何損害的預期。這當然不是我們在關鍵臨床試驗或開放標籤研究中看到的。我認為，值得注意的是，在服用羥丁酸期間，您不應在服用劑量後 6 小時內駕駛或操作重型機械。當您想到 LUMRYZ 時，它涵蓋了夜間睡眠期。當您考慮每晚兩次、90 分鐘的窗口期、何時可以服用第二劑、當患者較晚醒來時，這就是對額外 6 小時的限制，而這通常會干擾第二天的功能。

Thanks, Jen. Richard, anything you want to comment?

謝謝，珍。理查德，你有什麼要評論的嗎？

Yes. David, I just what I sort of add is quite interesting to me (inaudible) background. David. There we go. So David, to your question, as far as some of the counter messaging is concerned. So I think for us, the one thing we have realized over the last 20 years is I don't think anyone has really thought making patients wake up from the middle of the night has been normal. And where we see that most predominantly in our market research around de novo patients were absolutely consistently, physicians will state that they wouldn't want to start patients on LUMRYZ. Why would they offer a therapy, where you have to get up bring the middle of the night. And to Jen's point, we also know that the -- if there's any tolerability issues with occupancy, they generally tends to fly over time as well. But I think for us, where we sort of see it is physicians are speaking sort of with their boats as far as the need to not -- or the ability to not offer that segment dose is an intuitive proposition for new patients, that we believe will actually spill over into existing patients as well. So those are the counter messages that come up, we're more than prepared to deal with them. And we believe our campaigns will address them head on.

是的。大衛，我所添加的內容對我來說非常有趣（聽不清）背景。大衛。我們開始吧。大衛，對於你的問題，就一些反信息而言。所以我認為對我們來說，過去 20 年我們意識到的一件事是，我認為沒有人真正認為讓病人從半夜醒來是正常的。我們發現，在我們圍繞新發患者的市場研究中，大多數情況都是絕對一致的，醫生會表示他們不想讓患者開始使用 LUMRYZ。他們為什麼要提供一種治療，你必須在半夜起床。就 Jen 的觀點而言，我們還知道，如果入住率存在任何容忍度問題，它們通常也會隨著時間的推移而飛走。但我認為對我們來說，我們看到醫生正在與他們的船進行對話，只要不需要——或者不提供分段劑量的能力對於新患者來說是一個直觀的主張，我們相信實際上也會蔓延到現有患者身上。因此，這些是出現的反信息，我們已經準備好應對它們。我們相信我們的活動將正面解決這些問題。

That's helpful. If I may just sneak in a follow-up. Do you think, you're going to be able to pull in patients who've gone to low sodium already?

這很有幫助。我可以偷偷跟進一下嗎？您認為您能夠吸引已經接受低鈉治療的患者嗎？

Yes. So David, when we do our patient research, what we find about patients who have gone to the mixed fault version of the pricing the oxybate, they tend to be patients who have been diagnosed with narcolepsy for a shorter period of time. and they tend to be earlier adopters of therapy. They're generally not satisfied this treatment seeking more. So even though they have switched to the mix salt version, there -- all of our patient segments show extremely high level of interest in learning about LUMRYZ or potentially switching ironically, the highest group just nudging out the Xyrem patients are those on the mix salts. And our belief there is because they are the ones who are going to most often seek more that they can do to manage their narcolepsy.

是的。所以大衛，當我們進行患者研究時，我們發現接受羥丁酸定價混合錯誤版本的患者，他們往往是在較短的時間內被診斷為發作性睡病的患者。他們往往是治療的早期採用者。他們通常不滿意這種尋求更多的治療。因此，即使他們已經改用混合鹽版本，我們所有的患者群體都對了解 LUMRYZ 表現出極高的興趣，或者俱有諷刺意味的是，可能會改用混合鹽，而剛剛淘汰 Xyrem 患者的最高群體是那些使用混合鹽的患者。我們之所以相信這一點，是因為他們往往會尋求更多的方法來控制發作性睡病。

Our next question comes from the line of Marc Goodman with SVB Securities.

我們的下一個問題來自 SVB 證券公司的馬克·古德曼 (Marc Goodman)。

It's Rudy on the line for Marc. Congrats on the progress. Maybe kind of talk about your operating expenses in 2023 based on your current commercial launch planning. Now, we raised another around $200 million. Do you need additional funding before breakeven?

是魯迪接聽馬克的電話。祝賀取得的進展。也許可以根據您當前的商業發布計劃談談您 2023 年的運營費用。現在，我們又籌集了約 2 億美元。在盈虧平衡之前您需要額外的資金嗎？

Yes. Thanks for the question. We're really pleased with the amount of capital we raise. We're not providing guidance on operating expenses. We're heading into 2023. But from our standpoint with the capital that we now have, we're quite (inaudible) good to go for a launch.

是的。謝謝你的提問。我們對籌集的資金數額感到非常滿意。我們不提供有關運營費用的指導。我們即將進入 2023 年。但從我們現有資本的角度來看，我們非常（聽不清）非常適合推出。

So that's very helpful. And also can you talk about the IP. You mentioned that you have 13 patents now carrying these products, like what gives you the confidence about the strength of the IP position?

這非常有幫助。您還可以談談IP嗎？您提到您現在擁有13項專利來承載這些產品，是什麼讓您對知識產權地位的實力充滿信心？

Well, I think first and foremost, we're quite proud of the fact, that we're the first and only company to actually have innovated at once-at-bedtime or once-nightly oxybate treatment option, and you would assume that we have and we'll continue to protect it to its fullest extent. The patent families that have been granted so far, with many more to come, I would say we're quite confident in they're generally directed to once-nightly oxybate formulations, which includes, obviously, our formulation, but other types of formulations, prodrugs, (inaudible), alternate salts and whatnot, as well as methods of treating patients in a manner that we believe is consistent with what our final label will be. So we're quite confident in the robustness of our intellectual property, the 13 Orange Book listed patents we have so far, and the more to come.

嗯，我認為首先也是最重要的是，我們對此感到非常自豪，我們是第一家也是唯一一家真正創新了睡前一次或每晚一次羥丁酸治療方案的公司，你會認為我們我們將繼續最大限度地保護它。到目前為止已授予的專利族，還有更多的專利族，我想說，我們非常有信心，它們通常針對每晚一次的羥丁酯製劑，其中顯然包括我們的製劑，但也包括其他類型的製劑、前藥、（聽不清）、替代鹽等，以及以我們認為與我們最終標籤一致的方式治療患者的方法。因此，我們對我們知識產權的穩健性、我們迄今為止擁有的 13 項橙皮書列出的專利以及未來的更多專利充滿信心。

(Operator Instructions) Our next question comes from Matt Kaplan with Ladenburg Thalmann.

（操作員說明）我們的下一個問題來自 Matt Kaplan 和 Ladenburg Thalmann。

Just a couple of questions. In terms of maybe one for Richard, can you just provide some more color on the sales organization in terms of number of sales reps in a number of regions and kind of your go-to-market strategy with the sales team?

只是幾個問題。就理查德而言，您能否提供有關銷售組織的更多信息，包括多個地區的銷售代表數量以及您與銷售團隊的市場推廣策略？

Yes, sure, Matt. No problem. So our pricing for the sales force is based off of the insight, that there are less than 5,000 prescribers of oxybate in the last 3 years. Of that 1,600 mg up 80% of the volume in less than 500 mg up 50% of the total prescription volume. So we're sizing it at around 50 to really sort of focus on those groups. But right out of the gate, we're probably going to spend a little bit more time on the 1,600 that make up 80% of the prescription volume. Now we will cover the entire group and also including a few high narcotic prescribers, who don't use oxybate. And also interesting for us, if we do get some other sort of people interested earlier on, our REMS is almost like an early detection signal, which will allow us to get out to those offices and really ensure that they're set up well before that first prescription goes forward.

是的，當然，馬特。沒問題。因此，我們對銷售人員的定價是基於這樣的洞察：過去 3 年中，只有不到 5,000 名處方者服用羥丁酯。其中 1,600 毫克佔處方量的 80%，少於 500 毫克佔總處方量的 50%。因此，我們將其規模定為 50 左右，以真正關注這些群體。但一開始，我們可能會在佔處方量 80% 的 1,600 種藥物上多花一點時間。現在我們將覆蓋整個群體，還包括一些不使用羥丁酸的高濃度麻醉處方者。對我們來說也很有趣的是，如果我們確實早些時候讓其他類型的人感興趣，我們的 REMS 幾乎就像一個早期檢測信號，這將使我們能夠前往這些辦公室並真正確保它們在之前就已經建立起來。第一個處方繼續進行。

So, we're sort of going to focus where the oxybate experience is. And then from there, we can expand over time.

所以，我們將把重點放在羥丁體驗上。然後從那裡開始，我們可以隨著時間的推移進行擴展。

And then in terms of your patient support services center, how will that function to help patients get reimbursement and debt coverage?

那麼，就您的患者支持服務中心而言，該中心將如何幫助患者獲得報銷和債務保險？

Yes. It's one of the things that I would sort of see is going to be our secret fastest launch. We know prescribing a fulfilling any specialty product in the United States is a challenge. It's just not made it easy for folks. So, it's beyond our patient services center will be actually staffed with nurses, nurse care navigators. So they will understand more of both the clinical and the reimbursement aspects -- they're actually going to be credited in actual reimbursement services as well. So our goal there is, each office will actually have a dedicated person that they can build a longer-term relationship. It won't be sort of mixing and matching different years care navigators but the other thing that we are also building out concurrently and have already made offers for is our field reimbursement team.

是的。我希望看到的事情之一就是我們秘密的最快發射。我們知道，在美國開出滿足任何特殊產品的處方都是一項挑戰。這對人們來說並不容易。因此，我們的患者服務中心實際上不會配備護士、護士護理導航員。因此，他們將更多地了解臨床和報銷方面——他們實際上也會在實際的報銷服務中獲得認可。所以我們的目標是，每個辦公室實際上都會有一個專門的人員，他們可以建立長期的關係。它不會是混合和匹配不同年份的護理導航器，但我們也在同時建立並已經提出報價的另一件事是我們的現場報銷團隊。

And those are folks who will be able to go directly into the offices of these specialists and really helps support the staff that focuses on reimbursement, both in a live aspect there. And then the patient support center will help both office and also guide the actual individual patients themselves, as well. So we've really invested a lot of time and energy because first, we believe that the LUMRYZ value proposition will generate a lot of excitement with prescribers and patients. But we've got to make sure that we've had, and we've spent the time to build the resources to make sure that we can get the fulfillment taking care of as well.

這些人將能夠直接進入這些專家的辦公室，並真正幫助支持專注於報銷的工作人員，無論是在現場還是在現場。然後患者支持中心將幫助辦公室並指導實際的患者個人。因此，我們確實投入了大量的時間和精力，因為首先，我們相信 LUMRYZ 的價值主張將使處方醫生和患者感到非常興奮。但我們必須確保我們已經做到了這一點，並且我們已經花費了時間來構建資源，以確保我們也能得到滿足。

Okay. That's very helpful. And then a question for Tom, in terms of the royalty interest financing with RTW terms there. Can you help us understand in terms of the amount you'll have to pay back to RTW, if you pull down the full amount or if you don't -- if you only pull down the first tranche, is it 2.5x the funding? Or how does that work?

好的。這非常有幫助。然後是 Tom 的一個問題，涉及 RTW 條款的特許權使用費利息融資。您能否幫助我們了解一下，您需要償還給 RTW 的金額，如果您全額提取，或者不提取——如果您只提取第一筆款項，是資金的 2.5 倍嗎？ ？或者說這是如何運作的？

Yes. No, thanks, Matt. I think, one of the great things about the royalty financing is the flexibility we have on the second tranche, where it's really at our option to draw it or not. So if you focus on the first tranche, it's in our 8-K filing, a lot of details out there, but the hard cap is 2.5x.

是的。不，謝謝，馬特。我認為，特許權使用費融資的一大優點是我們在第二部分中具有靈活性，我們可以選擇提取或不提取它。因此，如果你關注第一部分，它就在我們的 8-K 文件中，其中有很多細節，但硬上限是 2.5 倍。

That concludes today's question-and-answer session. I'd like to turn the call back to Greg Divis for closing remarks.

今天的問答環節到此結束。我想將電話轉回給格雷格·迪維斯，讓其作結束語。

Thank you, and thank you, everyone. Thank you for your time and joining us today, on our fourth quarter and full year 2022 earnings call. We appreciate your spending the morning with us and wish you a great rest of your day. Thanks.

謝謝你們，也謝謝大家。感謝您今天抽出時間參加我們的 2022 年第四季度和全年財報電話會議。我們感謝您與我們一起度過了一個上午，並祝您度過愉快的一天。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。