Aurinia Pharmaceuticals Inc (AUPH) 2023 Q4 法說會逐字稿

Greetings, and welcome to Arena Pharmaceuticals full year 2023 earnings call. (Operator Instructions) As reminder, this conference is being recorded. I would now like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communications and Investor Relations for Aurinia Pharmaceuticals. Thank you. You may begin.

您好，歡迎參加 Arena Pharmaceuticals 2023 年全年財報電話會議。 （操作員說明） 請注意，本次會議正在錄製中。現在我想將會議交給主持人 Aurinia Pharmaceuticals 企業傳播和投資者關係主管 Andrea Christopher。謝謝。你可以開始了。

Thank you, operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's Chief Executive Officer, and Joe Miller, our Chief Financial Officer. David will review and discuss Aurinia's 2023, fourth quarter and year end financial and operational results as well as an update on our strategic review. As communicated in the company's press release issued this morning, the Company also filed its annual financial statements on Form 10 K this morning, for more information, please refer to AirMedia's filings with the US Securities and Exchange Commission and applicable Canadian securities authorities, which are also available on Iridium's website at reatapharma.com. During today's call, or you may make forward looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially for a discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in our earnings press release and its annual report on Form 10 K and all of its recent filings with the US Securities and Exchange Commission and Canadian securities authorities. Please note that all statements made today during today's call are current as of today, Thursday, February 15th, 2024, unless otherwise noted and are based upon information currently available to us, except as required by law, Aurinia assumes no obligation to update any such statements Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

謝謝接線員，也謝謝大家參加今天的電話會議和網路廣播。今天早上與我一起參加電話會議的有 Aurinia 執行長 Peter Greenleaf 和我們的財務長 Joe Miller。 David 將回顧和討論 Aurinia 的 2023 年、第四季和年終財務和營運業績，以及我們策略審查的最新情況。正如今天上午發布的公司新聞稿中所述，公司今天上午還提交了10 K 表格年度財務報表，更多資訊請參閱航美傳媒向美國證券交易委員會和適用的加拿大證券監管機構提交的文件，這些文件包括：也可在 Iridium 網站 reatapharma.com 上取得。在今天的電話會議中，您也可以根據目前的預期做出前瞻性陳述。這些前瞻性陳述受到許多重大風險和不確定性的影響，對於可能影響 Aurinia 未來財務業績和業務的因素的討論，實際結果可能存在重大差異，請參閱我們的收益新聞稿及其年度報告中的披露報告10 K 表格及其最近向美國證券交易委員會和加拿大證券監管機構提交的所有文件。請注意，今天在今天的電話會議上發表的所有聲明均為截至今天（2024 年2 月15 日星期四）的最新聲明，除非另有說明，並且均基於我們當前掌握的信息，除非法律要求，Aurinia不承擔更新任何此類聲明的義務聲明 現在讓我將電話轉給 Aurinia 總裁兼執行長 Peter Greenleaf。彼得？

Thanks, Andrea, and good morning, everyone. I want to thank everybody for joining us on today's call. As you may have noted, we issued preliminary unaudited fourth quarter and year end numbers in early January. On today's call, we will provide you with the final audited results for the fourth quarter and the year end 2023 also provide an update on our commercial activities, including key commercial metrics and significant highlights for live kinase. We will then provide an update with the Company's previously announced strategic review and our business strategy moving forward. This includes our near term plan to restructure the Company and the initiation of a share repurchase program we believe this plan allows for immediate enhancement of shareholder value and has the ability to strengthen the Company's long-term financial picture. After walking you through these details, I will then turn the call over to Joe Miller, our CFO, to provide additional details on our financial results.

謝謝，安德里亞，大家早安。我要感謝大家參加今天的電話會議。正如您可能已經注意到的，我們在一月初發布了未經審計的初步第四季度和年終數據。在今天的電話會議上，我們將為您提供第四季度和 2023 年底的最終審計結果，並提供我們商業活動的最新信息，包括活激酶的關鍵商業指標和重要亮點。然後，我們將提供公司先前宣布的策略審查和未來業務策略的最新資訊。這包括我們重組公司的近期計劃和啟動股票回購計劃，我們相信該計劃可以立即提高股東價值，並有能力加強公司的長期財務狀況。在向您介紹了這些詳細資訊後，我會將電話轉給我們的財務長喬·米勒 (Joe Miller)，以提供有關我們財務業績的更多詳細資訊。

So now let me dive into the overall business performance for the full year 2023 or Renee achieved $175.5 million in total net revenue, which represented an increase of approximately 31% over the prior year. We achieved $158.5 million in net product revenue, representing an increase of 53% over 2022. For the fourth quarter of 2023 we achieved total a total revenue of 45.1 million and a total net product revenue of $42.3 million, which represented an increase of 59% and 49% over the same period in 2022.

那麼現在讓我深入了解 2023 年全年的整體業務表現，Renee 實現了 1.755 億美元的總淨收入，比上一年增長了約 31%。我們實現了 1.585 億美元的產品淨收入，比 2022 年成長了 53%。2023年第四季，我們的總營收為4,510萬美元，產品淨收入為4,230萬美元，較2022年同期成長59%及49%。

Moving to more detail behind our financial results. During the fourth quarter, Aurinia added 438 patient start forms or PSS compared to 406 PSS in the fourth quarter of 2022 and 436 in the third quarter of 2023. In addition to the 438 PSS added in the fourth quarter, the company also added approximately 101 new additional patients. This includes restarts defined as patients coming back onto therapy who do not require a PSF. and an estimate of new patients beginning therapy in the hospital channel. The addition of patient restarts and patients coming through the hospital channel are newly reported in the fourth quarter since they've achieved numerical significance for the first time, hospital and restart numbers are both new indicators of growth for us. We know that restart patients have been off therapy for a considerable amount of time before restarting restarts represent a strong indicator for the brand because they demonstrate that physicians are comfortable using loop kinase as a first line therapy, and they likely indicate the importance of maintaining loop kinase for a sustained period of time. It's important to note that treating flares is not aligned with the most recent treatment guidelines. These guidelines out there call for patients to remain on therapy for three to five years.

更詳細地了解我們的財務表現。第四季度，Aurinia 增加了 438 份病患起始表格或 PSS，而 2022 年第四季為 406 份 PSS，2023 年第三季為 436 份。除了第四季度新增的 438 名 PSS 之外，該公司還新增了約 101 名新患者。這包括重新開始，定義為不需要 PSF 的患者重新接受治療。以及在醫院通路開始治療的新病患的估計。第四季新報告的病患復工數和透過醫院管道進入的病患數首次達到了數值意義，醫院數和復工數對我們來說都是新的成長指標。我們知道，重新開始治療的患者在重新開始之前已經停止治療相當長的時間，重新開始代表了該品牌的一個強有力的指標，因為它們表明醫生願意使用環激酶作為一線治療，並且它們可能表明維持環激酶的重要性激酶持續一段時間。值得注意的是，治療耀斑並不符合最新的治療指引。這些指南要求患者繼續接受治療三到五年。

I'll talk more about our commercial strategy in a moment, but this is why we continue to encourage physicians to follow the guidelines and treat lupus nephritis more aggressively.

稍後我將詳細討論我們的商業策略，但這就是為什麼我們繼續鼓勵醫生遵循指南並更積極地治療狼瘡腎炎。

Regarding our hospital numbers, we ship wallets to hospital pharmacies with little to no visibility into how these hospitals are dispensing the drug to actual patients. Therefore, we estimate how many patients come from those wallets based on average wallet utilization across all patients. As previously discussed, the hospital market was completely closed off to us through the first two years of the launch due to the global pandemic. Now that we have a broader hospital access. We're looking closely at how we approach these institutions and addressing some of the complexities that are inherent in the hospital systems and integrated health care networks. We're beginning to see the impact of our execution in this space with the wallet shipments and patients beginning to pull through. For the full year, we added a total of 1,791 PSS, an increase of approximately 9% year over year and from January first, 2024 through January or February ninth of the same year, we added approximately 191 PSS. Adding to the PSF number, we have approximately 40 new patients from both restarts and the hospital channel. In addition, I'm pleased to report that our conversion rates continue to improve with approximately 85% of PSS converted to therapy. We're also improving the time it takes to get patients on therapy throughout 2023 we increased our processing speed at all time periods 30, 60 and 90 days was 63% of our patients starting therapy in 20 days or less. I'd like to point out that this is a meaningful improvement year over year. Our 12 month persistency continues to improve and is now approximately 55%. We are encouraged to see almost 45% of patients who remain on therapy at 18 months with that number holding steady out to 24 months and consistent with prior periods, adherence to loop with balloon sinus treatment remained strong at approximately 86% at year end. The increase in patients on therapy in the quarter was driven predominantly by improvements in new PSS patient restarts, hospital fills conversion rates and processing speeds and overall improvements in persistency. Exiting 2023, a total of 2066 patients were on therapy. This represents an increase of over 35% over 2022. As we stated on previous calls, our strategy to grow loop kinase in the lupus nephritis market is focused on three key areas. First, educating health care providers on the need to screen and treat more aggressively, second, activating the patient to proactively discuss screening and treatment with their physicians. And lastly, continuing to clinically differentiate new kinase and position it as part of the foundation therapy in the treatment of lupus nephritis to address it. First, we continue to increase our focus on health care professionals and key opinion leaders by leveraging our long term clinical data and the updated you Lorine KDIGO guidelines. Our messaging is focused on encouraging physicians to recognize that all SLE patients may be at risk for lupus nephritis and that active screening for and routinely monitoring lupus nephritis patients are critical, prioritizing early diagnosis with every SLE patient treating to target goals and reducing protein protein levels to minimize steroid use start treatment with effective and effective combination therapy and leverage combination therapies with the goal of increased renal response. And lastly, continuing to treat for at least three to five years following a complete renal response, we're already seeing meaningful impact from these clinical developments, and we will continue to reinforce this messaging through our robust marketing and sales efforts.

關於我們的醫院數量，我們將錢包運送到醫院藥房，幾乎不了解這些醫院如何向實際患者配藥。因此，我們根據所有患者的平均錢包利用率來估計有多少患者來自這些錢包。如前所述，由於全球大流行，醫院市場在推出的頭兩年對我們完全關閉。現在我們有了更廣泛的醫院准入機會。我們正在密切關注如何與這些機構打交道，並解決醫院系統和綜合醫療保健網路固有的一些複雜性。隨著錢包發貨和患者開始渡過難關，我們開始看到我們在這個領域的執行所產生的影響。全年，我們總共增加了 1,791 個 PSS，年增約 9%，從 2024 年 1 月 1 日到同年 1 月或 2 月 9 日，我們增加了約 191 個 PSS。除了 PSF 數量之外，我們還有來自重啟管道和醫院管道的大約 40 名新患者。此外，我很高興地報告，我們的轉換率持續提高，大約 85% 的 PSS 轉化為治療。我們也縮短了患者在2023 年接受治療所需的時間，我們提高了所有時間段（30 天、60 天和90 天）的處理速度，63% 的患者在20 天或更短的時間內開始治療。我想指出的是，這是逐年有意義的進步。我們的 12 個月持久性持續改善，目前約為 55%。我們很高興地看到，近45% 的患者在18 個月時仍繼續接受治療，這一數字在24 個月內保持穩定，並且與之前的時期一致，到年底，球囊鼻竇循環治療的依從性仍然很高，約86%。本季度接受治療的患者數量增加主要是由於新 PSS 患者重新啟動、醫院填充轉換率和處理速度以及持久性整體改善的改善。截至 2023 年，共有 2066 名患者正在接受治療。這比 2022 年增長了 35% 以上。正如我們在先前的電話會議中所說，我們在狼瘡性腎炎市場發展環激酶的策略主要集中在三個關鍵領域。首先，教育醫療保健提供者需要更積極地進行篩檢和治療，其次，激發患者主動與醫生討論篩檢和治療。最後，繼續在臨床上區分新激酶，並將其作為治療狼瘡性腎炎的基礎療法的一部分來解決這個問題。首先，我們利用我們的長期臨床數據和更新的 Lorine KDIGO 指南，繼續加強對醫療保健專業人員和關鍵意見領袖的關注。我們的資訊重點是鼓勵醫生認識到所有SLE 患者都可能面臨狼瘡性腎炎的風險，主動篩檢和定期監測狼瘡性腎炎患者至關重要，優先考慮對每位SLE 患者進行早期診斷，以實現目標治療並降低蛋白質水平為了盡量減少類固醇的使用，開始採用有效且有效的聯合療法進行治療，並利用聯合療法以增加腎臟反應為目標。最後，在完全腎臟反應後繼續治療至少三到五年，我們已經看到這些臨床發展的有意義的影響，我們將繼續透過強大的行銷和銷售努力強化這一訊息。

In terms of patient activation. We focus our efforts on educating SLE and lupus nephritis patients and driving them to have provocative and proactive conversations with their physicians about screening and treatment. Our messaging reinforces the importance of routine urine screening, the seriousness of the end of the threat of lupus nephritis progressing and the critical need to start and stay on treatment. We deliver these messages through a mix of highly targeted social and digital initiatives as well as in-person advocacy events.

在患者激活方面。我們的重點是教育 SLE 和狼瘡腎炎患者，並促使他們與醫生就篩檢和治療進行積極主動的對話。我們的訊息強調了常規尿液篩檢的重要性、狼瘡性腎炎進展威脅結束的嚴重性以及開始和堅持治療的迫切需求。我們透過高度針對性的社交和數位措施以及面對面的宣傳活動來傳遞這些訊息。

Finally, our customer-facing teams are focused on clinical differentiation and delivering the loop kinase clinical story targeted towards the highest potential writers. Our activities against these targets have steadily increased throughout 2023. And in the fourth quarter, we further increased the depth of prescribing in our current base of customers and in addition, expanded new customers and new riders.

最後，我們面向客戶的團隊專注於臨床差異化，並為最具潛力的作家提供環激酶臨床故事。2023 年，我們為實現這些目標而進行的活動穩定增加。在第四季度，我們進一步增加了現有客戶群的處方深度，此外還擴大了新客戶和新騎士。

Building on the momentum we established in the fourth quarter, we now have over 5,000 PSS since launch. And based on everything we've discussed today, we are reaffirming our 2024 net product revenue guidance range of 202 hundred and 20 million.

憑藉我們在第四季度建立的勢頭，自推出以來我們現在擁有超過 5,000 個 PSS。基於我們今天討論的所有內容，我們重申 2024 年產品淨收入指引範圍為 202 億 2,000 萬美元。

Shifting gears, I'd like to now discuss the conclusion of our strategic review and provide additional context, please note that you will find further details of the review located within our recently issued annual report on Form 10 K and related press release. To remind everyone, our we got here in connection with our annual general meeting held May 17th of 2023. Certain shareholders expressed their desire for the Company to undergo a strategic review process. At the 2023 AGM, two of the company's most senior and experienced nominees for directors did not receive requisite majority under the company's majority voting policy and accordingly submitted their resignation to the Board. Those resigning members were replacement two new directors, both with significant pharma and business development backgrounds. And additionally, in connection with the collaboration agreement that we entered into with one shareholder, we agreed to appoint Dr. Robert Foster, the inventor of voclosporin to our Board. Given the results of the AGM as well as the desires expressed by certain shareholders.

換個話題，我現在想討論我們戰略審查的結論並提供更多背景信息，請注意，您可以在我們最近發布的 10 K 表格年度報告和相關新聞稿中找到有關審查的更多詳細信息。提醒大家，我們今天召開此會議是為了配合 2023 年 5 月 17 日舉行的年度股東會。某些股東表達了希望公司進行策略審查的意願。在 2023 年年度股東大會上，公司兩名最資深、經驗最豐富的董事提名人沒有獲得公司多數投票政策規定的必要多數票，因此向董事會提交了辭呈。這些辭職的成員接替了兩名新董事，兩人都具有重要的製藥和業務發展背景。此外，根據我們與一位股東簽訂的合作協議，我們同意任命沃羅孢素的發明者羅伯特·福斯特博士加入我們的董事會。鑑於年度股東大會的結果以及某些股東表達的願望。

On June 29th of 2023, the company announced that it had initiated exploration of strategic alternatives. It was noted that the process would consider a wide range of options for the company, including but not limited to a potential sale merger or other strategic transactions.

2023年6月29日，該公司宣布已開始探索策略替代方案。值得注意的是，該流程將考慮公司的多種選擇，包括但不限於潛在的銷售合併或其他策略交易。

The Company retained JP Morgan as its financial adviser to lead the strategic review following the announcement of the process, JPMorgan and already have put together a comprehensive data room as corporate presentation and materials to support the overall review process. Jp Morgan then engaged with more than 60 parties that engagement led to 11 nondisclosure agreements being signed with potentially interested parties. Array also conducted multiple meetings and presented to multiple parties, including some that did not sign nondisclosure agreements on a non-confidential basis. The data room Accel itself was extensive containing over 200,000 pages of materials across 4,300 files despite significant effort put into the exploration of strategic alternatives from a renewed board, its management and our advisers only one party submitted a preliminary non-binding expression of interest, which remains subject to customary conditions, including a formal due diligence. After a review of that expression of interest, Array's Board elected to allow that party into a detailed formal diligence process at the conclusion of its diligence process, the counterparty elected not to submit a formal offer in addition to exploring the sale of a company or any also explored multiple alternatives including the potential for acquiring merging or licensing other entities. Our assets Board ultimately determined that none of the other alternatives explored and that were available to it to pursue were in the best interest of the Company and its shareholders. Based on the outcome of this extensive strategic review, the Board believes that the best path forward is for management to streamline its operations as announced today and focus on the company's commercial execution. We expect this to provide us with financial firepower to generate meaningful cash flow, which we intend to redeploy in the short term to repurchase shares and over time continue to build balance sheet strength. We believe this strength will provide us with the financial flexibility to consider a wide wide range of alternatives over the next few years. This could include diversifying our portfolio through the addition of new pipeline assets or creating scale through the acquisition of commercial assets or other strategies that we believe will allow the Company to continue to grow and drive towards its mission for even more context, in 2018, the company under previous management and at the Board's direction engaged a leading investment bank and conducted a confidential strategic review process. After extensive outreach, the company received only one non-binding expression of interest, which included a due diligence process, but in the end did not result in a formal offer. And outside of these two expressions of interest, the Company has never received any offer of any kind. The Board management, though remain open to exploring opportunities that are in the best interest of the company and are open to considering any bona fide offers that the company receives.

該公司聘請摩根大通作為其財務顧問，在流程公佈後領導戰略審查，摩根大通已經建立了一個全面的數據室作為公司演示和材料，以支持整個審查流程。摩根大通隨後與 60 多個各方進行了接觸，最終與潛在感興趣的各方簽署了 11 份保密協議。Array 還舉行了多次會議並向多方進行了演示，其中包括一些未簽署非保密協議的各方。儘管新董事會、其管理層和我們的顧問在探索策略替代方案方面付出了巨大努力，但Accel 資料室本身內容廣泛，包含4,300 個文件中的200,000 多頁資料，但只有一方提交了一份初步的、不具約束力的意向書，其中仍須遵守慣例條件，包括正式的盡職調查。在審查該意向書後，Array 董事會選擇允許該方在其盡職調查程序結束時進入詳細的正式盡職調查程序，而交易對方除了探索出售公司或任何其他公司之外，選擇不提交正式要約。還探索了多種替代方案，包括收購合併或授權其他實體的可能性。我們的資產董事會最終確定，所探索和可供其追求的其他替代方案都不符合公司及其股東的最佳利益。根據此次廣泛策略審查的結果，董事會認為，管理層的最佳前進道路是按照今天宣布的那樣精簡其運營，並專注於公司的商業執行。我們預計這將為我們提供財務火力，以產生有意義的現金流，我們打算在短期內重新部署現金流以回購股票，並隨著時間的推移繼續增強資產負債表實力。我們相信，這種優勢將為我們提供財務靈活性，以便在未來幾年內考慮各種替代方案。這可能包括透過增加新的管道資產來實現我們的投資組合多元化，或透過收購商業資產或其他策略來擴大規模，我們相信這些策略將使公司能夠繼續發展並推動其在更多背景下實現其使命，2018 年，公司在前管理層的領導下，在董事會的指導下，聘請了一家領先的投資銀行，並進行了保密的策略審查流程。經過廣泛的接觸後，該公司只收到了一份不具約束力的意向書，其中包括盡職調查過程，但最終沒有產生正式要約。除了這兩次意向書外，該公司從未收到任何形式的要約。不過，董事會管理層仍願意探索符合公司最佳利益的機會，並願意考慮公司收到的任何善意要約。

In addition, following the conclusion of the strategic review, the Company has reaffirmed reaffirming its commitment to the value enhancement by driving loop kinase growth while maintaining a sharp focus on operating efficiencies and maximizing cash flows. As a result, the Company is ceasing further development of both AUR. 200 and AUR. 300. Correspondingly, the Company expects to take a restructuring charge of approximately 11 to 15 million in the first quarter of 2020. For this charge will primarily be made up of severance costs, contract termination costs and other costs associated with terminating these programs, we anticipate reducing employee headcount by at least 25% by the end of the first quarter of 2024. There is no planned reduction in headcount in commercial or commercial supporting roles. The Company expects to recognize annual cost savings of approximately 50 to 55 million on a go-forward basis with no impact on our commercial investments. In addition, the Board has approved a share repurchase program of up to 150 million of the Company's common shares, the maximum amount of which is subject to receipt of regulatory approval in Canada. This reflects confidence in Aurinia's growth prospects and a continued commitment to enhancing both short and long-term value for shareholders and other stakeholders. While we know there will be questions about timing and details of this near term strategic shift, I can tell you that we will execute quickly and decisively to maximize the benefits. And I'd now like to turn the call over to Joe to provide additional details of the share repurchase program that we announced today, as well as more detailed review of our financial results. I will then return at the end of the call for a quick recap and to open up the line for your questions. With that, Joe?

此外，在策略審查結束後，公司重申其透過推動環激酶成長來提升價值的承諾，同時保持對營運效率和現金流最大化的高度重視。因此，公司將停止進一步開發 AUR。 200 和 AUR。 300.相應地，公司預計2020年第一季將承擔約11至1500萬的重組費用。由於這筆費用主要由遣散費、合約終止成本以及與終止這些計劃相關的其他成本組成，我們預計到 2024 年第一季末將員工人數減少至少 25%。沒有計劃減少商業或商業支援職位的人數。公司預計每年可節省約 5,000 至 5,500 萬美元的成本，且不會影響我們的商業投資。此外，董事會還批准了一項最多 1.5 億股公司普通股的股票回購計劃，最高金額尚需獲得加拿大監管部門的批准。這反映了對 Aurinia 成長前景的信心以及對提高股東和其他利害關係人的短期和長期價值的持續承諾。雖然我們知道人們會對這一近期戰略轉變的時間表和細節存在疑問，但我可以告訴您，我們將迅速而果斷地執行，以實現利益最大化。現在我想將電話轉給喬，以提供我們今天宣布的股票回購計劃的更多細節，以及對我們財務業績的更詳細審查。然後，我將在通話結束時回來進行快速回顧，並為您解答問題。就這樣，喬?

Thank you, Peter, and good morning, everyone. As Peter previewed the Board has approved a share repurchase program of up to $150 million in common shares of the company, of which the maximum amount is subject to receipt of exemptive relief in Canada. If granted, it would permit Aurinia to purchase up to 15% of the issued and outstanding common shares of the company in any 12-month period over 36 months. There is no assurance that exemptive relief will be granted. If the exemptive relief is not granted, the maximum the Company may purchase under the share repurchase program is 5% of our current issued and outstanding common shares being 7,230,888 common shares. We plan to begin opportunistic discretionary purchases of shares on the open market beginning on or around February 21st, 2024, the Company expects to fund the share repurchases from cash flows from operations and cash currently on hand. Further details can be found in our recently issued press release and Form 10 K. I want to emphasize that this repurchase program truly reflects our confidence in Arena's growth prospects.

謝謝你，彼得，大家早安。正如 Peter 所預述的那樣，董事會已批准一項高達 1.5 億美元的公司普通股回購計劃，其中最高金額須在加拿大獲得豁免。如果獲得批准，將允許 Aurinia 在 36 個月內的任何 12 個月內購買該公司最多 15% 的已發行和流通普通股。無法保證會給予豁免救濟。如果不給予豁免，公司根據股票回購計畫最多可以購買我們目前已發行和流通在外的普通股的 5%，即 7,230,888 股普通股。我們計劃從 2024 年 2 月 21 日左右開始在公開市場上擇機酌情購買股票，公司預計將透過營運現金流和當前手頭現金為股票回購提供資金。更多詳情請參閱我們最近發布的新聞稿和 10 K 表格。我想強調的是，這次回購計畫真正反映了我們對 Arena 成長前景的信心。

Now let's take a few moments and go into detail regarding our financial results for the fourth quarter and 12 months ended December 31st, 2023. As of December 31st, 2023, Aurinia had cash, cash equivalents and restricted cash and investments of $350.7 million compared to 389.4 million at December 31st, 2022. The decrease is primarily related to the continued investment in commercialization activities and post-approval commitments of our approved drug with kinase inventory purchases advancement of our pipeline and mono plant payments, partially offset by an increase in cash receipts from sales of Group guidance.

現在，讓我們花點時間詳細了解我們截至 2023 年 12 月 31 日的第四季和 12 個月的財務表現。截至 2023 年 12 月 31 日，Aurinia 擁有現金、現金等價物以及限制性現金和投資為 3.507 億美元，而 2022 年 12 月 31 日為 3.894 億美元。這項減少主要與對商業化活動的持續投資以及我們批准的藥物的批准後承諾有關，其中包括激酶庫存採購、我們的管道的進展和單一工廠付款，部分被集團指導銷售現金收入的增加所抵消。

Total net revenue increased 59% to $45.1 million for the fourth quarter compared to the prior year period of $28.4 million. Total net revenue for the year was $175.5 million, an increase of over 31% over the prior year period of 134 million. Total net product product revenue increased 49% to 42.3 million for the fourth quarter compared to the prior year period of $28.4 million. Total net product revenue was $158.5 million and 103.5 million for the years ended December 31st, 2023 and 2022. The increase in both periods is primarily due to an increase in our two main customers who live time. This sales driven predominantly by further penetration of the all end markets, license collaboration and royalty revenue was 2.8 million for the fourth quarter compared to the prior year period of 109,000. License collaboration royalty revenue was $17 million and $36.6 million for the years ended December 31st, 2023 and 2022, respectively. For the years ended December 31st, 2023, license collaboration and royalty revenue included a $10 million pricing and reimbursement milestone and additional collaboration and manufacturing service revenue from Otsuka for the year ended December 31st, 2022, license collaboration and royalty revenue was primarily due to the recognition of a $30 million regulatory milestone from Otsuka following the EC. marketing authorization of live kinase in September of 2022 cost of sales and operating expenses for the fourth quarter ended December 31st, 2023 and December 31st, 2022 were $74.8 million and 56.5 million. Total cost of sales and operating expenses were 267.2 million and $245.5 million for the years ended December 31st, 2023 and December 31st, 2022.

第四季總淨收入成長 59%，達到 4,510 萬美元，去年同期為 2,840 萬美元。全年淨收入總額為 1.755 億美元，比去年同期的 1.34 億美元成長 31% 以上。第四季產品淨收入總額成長 49%，達到 4,230 萬美元，去年同期為 2,840 萬美元。截至2023年12月31日及2022年12月31日止年度，產品淨收入總額分別為1.585億美元及1.035億美元。這兩個時期的增加主要是由於我們的兩個主要客戶居住時間的增加。這項銷售額主要由終端市場的進一步滲透、授權合作和特許權使用費收入推動，第四季銷售額為 280 萬美元，而去年同期為 109,000 美元。截至2023年12月31日及2022年12月31日的年度授權合作特許權使用費收入分別為1,700萬美元及3,660萬美元。截至2023年12月31日止年度，許可合作和特許權使用費收入包括1000萬美元的定價和報銷里程碑以及截至2022年12月31日止年度來自大塚的額外合作和製造服務收入，許可合作和特許權使用費收入主要是由於繼歐盟委員會之後，大塚認可了 3000 萬美元的監管里程碑。活激酶於2022年9月獲得行銷授權 截至2023年12月31日和2022年12月31日的第四季銷售成本和營運費用分別為7,480萬美元和5,650萬美元。截至2023年12月31日及2022年12月31日止年度，銷售成本及營運費用總額分別為2.672億美元及2.455億美元。

Let me now give you a further breakdown of operating expenses, drivers and fluctuations, cost of sales were EUR5.4 million and 1.4 million for the quarters ended December 31st, 2023 and December 31st, 2022. Cost of sales for the year ended December 31st, 2023 were 14.1 million and $5.7 million for the year ended December 31st, 2022. The increase in both periods was primarily due to increased sales of LoopCare. And this coupled with the amortization of the mono plant finance lease right-of-use asset, which was placed into service in late June 2023. Gross margin for the quarter ended December 31st, 2023 and December 31st, 2022, was approximately 88% and 95%. Gross margins for the year ended December 31st, 2023 and December 31st, 2022 was approximately 92% and 96% selling, general and administrative expenses, inclusive of share-based compensation expense were $50.1 million and $47.5 million for the fourth quarters 2023 and 2022, respectively. The increase in total SG&A was primarily due to an increase in share-based compensation expense for the years ended December 31st, 2023, SG&A expenses, inclusive of share-based compensation expense was $195 million for the year ended December 31st, 2022, SG&A expenses, inclusive of share-based compensation was $196.4 million. The decrease was primarily due to a reduction in expenses associated with corporate legal matters and insurance. Non-cash SG&A share-based compensation expense was 9.5 million and 7 million for the quarters ended December 31st, 2023 and December 31st, 2022, non-cash SG&A share based compensation expense was $36.5 million and 28.4 million for the years ended December 31st, 2023 and December 31st, 2022. Research and development expenses, inclusive of share-based compensation expense were 10.2 million and 9.9 million for the quarters ended December 31st, 2023 and December 31st, 2022. R and D expenses, inclusive of share-based compensation expense were $49.6 million and 45 million for the years ended December 31st, 2023, December 31st, 2022. The primary driver for the increase in R&D expenses for both periods was due to an increase in share-based compensation expense for the quarter ended December 31st, 2023, non-cash R & D share based compensation expense was 1.9 million for the quarter ended December 31st, 2022, noncash R&D shared base compensation was income of 260,000 noncash R&D share-based compensation expense was $7.5 million and $3.3 million for the years ended December 31st, 2023 and December 31st, 2022. Other expense was 9.1 million versus other income of $2.2 million for the quarters ended December 31st, 2023 and December 31st, 2022, respectively. Other expense was 8.4 million versus other income of $1.5 million for the years ended December 31st, 2023 and December 31st, 2022. The increase in expense for both periods is primarily the increase of the foreign exchange loss related to the revaluation of the model plan finance lease liability which commenced in June 2023 and is denominated in CHF.

現在讓我進一步詳細介紹營運費用、驅動因素和波動情況，截至 2023 年 12 月 31 日和 2022 年 12 月 31 日的季度銷售成本分別為 540 萬歐元和 140 萬歐元。截至2023年12月31日止年度的銷售成本為1,410萬美元，截至2022年12月31日止年度的銷售成本為570萬美元。這兩個時期的成長主要是由於 LoopCare 銷售額的增加。再加上 2023 年 6 月下旬投入使用的單體工廠融資租賃使用權資產的攤提。截至2023年12月31日及2022年12月31日的季毛利率約為88%及95%。截至2023年12月31日和2022年12月31日止年度的毛利率約為92%和96%，銷售、一般和管理費用（包括基於股份的補償費用）在2023年和2022年第四季度分別為5010萬美元和4750萬美元，分別。SG&A 總額的增加主要是由於截至 2023 年 12 月 31 日止年度的股權激勵費用增加，截至 2022 年 12 月 31 日止年度的 SG&A 費用（包括股權激勵費用）為 1.95 億美元，SG&A 費用，包括股權薪酬為1.964 億美元。減少的主要原因是與公司法律事務和保險相關的費用減少。截至2023年12月31日及2022年12月31日的季度，非現金SG&A股份補償費用分別為950萬美元及700萬美元；截至12月31日的年度，非現金SG&A股份補償費用分別為3,650萬美元和2840萬美元， 2023年和2022年12月31日。截至2023年12月31日及2022年12月31日的季度，研發費用（含股權激勵費用）分別為1,020萬美元及990萬美元。截至2023年12月31日及2022年12月31日止年度，研發費用（含股權激勵費用）分別為4,960萬美元及4,500萬美元。兩個時期研發費用增加的主要驅動因素是截至2023年12月31日的季度的股權激勵費用增加，截至2023年12月31日的季度的非現金研發股權激勵費用為190萬美元截至2022年12月31日，截至2023年12月31日及2022年12月31日止年度，非現金研發共享基礎薪資收入為260,000非現金研發共享基礎薪資支出為750萬美元及330萬美元。截至2023年12月31日及2022年12月31日的季度，其他費用為910萬美元，而其他收入為220萬美元。截至2023年12月31日及2022年12月31日止年度，其他費用為840萬美元，其他收入為150萬美元。兩個期間的費用增加主要是與 2023 年 6 月開始的以瑞士法郎計價的模型計劃融資租賃負債重估相關的外匯損失增加。

Interest income was 4.6 million for the quarter ended December 31st, 2023, and 2.9 million for the quarter ended December 31st, 2022. Interest income was $17 million and $5.1 million for the years ended December 31st, 2023 and December 31st, 2020 to increase for the quarter and full year was primarily due to higher yields in our investment as a result of higher interest rates year over year. For the quarter ended December 31st, 2023, Arena had recorded a net loss of $26.9 million, or $0.19 net loss per common share as compared to a net loss of $26 million or $0.18 net loss per common share for the quarter ended December 31st, 2022. For the year ended December 31st, 2023, Aurinia recorded a net loss of $78 million or $0.54 net loss per common share as compared to a net loss of $108.2 million or $0.76 net loss per common share for the previous period.

截至2023年12月31日的季度利息收入為460萬，截至2022年12月31日的季度利息收入為290萬。截至2023年12月31日和2020年12月31日止年度，本季和全年的利息收入分別為1700萬美元和510萬美元，這主要是由於利率逐年上升導致我們的投資收益率較高。截至2023年12月31日的季度，Arena錄得淨虧損2690萬美元，或每股普通股淨虧損0.19美元，而截至2022年12月31日的季度淨虧損為2600萬美元，或每股普通股淨虧損0.18美元。截至2023 年12 月31 日的年度，Aurinia 錄得淨虧損7,800 萬美元，或每股普通股淨虧損0.54 美元，而上一期間的淨虧損為1.082 億美元，或每股普通股淨虧損0.76 美元。

With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?

至此，我想將電話轉回給 Peter 進行總結發言。彼得？

Thanks, Joe. I want to close by saying that we've built a strong foundation for renewed growth. This near term shift will make us financially stronger in the years to come. It will allow us more financial flexibility to continue to explore a range of strategic initiatives. We have a deeply experienced management team that's dedicated and committed to driving commercial success of loop kinase and improving the lives of people suffering from lupus nephritis. We're looking forward to a continued strong performance carry through in 2024. And I want to thank you all for joining us and giving us your time today. I'll now open the lines for any questions. Operator?

謝謝，喬。最後我想說，我們已經為新的成長奠定了堅實的基礎。這一近期轉變將使我們在未來幾年的財務狀況更加強大。這將使我們擁有更大的財務靈活性，以繼續探索一系列策略舉措。我們擁有一支經驗豐富的管理團隊，致力於推動環激酶的商業成功並改善狼瘡性腎炎患者的生活。我們期待 2024 年繼續保持強勁的業績。我要感謝大家今天加入我們並抽出寶貴的時間。如果有任何問題，我現在將開放熱線。操作員？

(Operator Instructions) Maury Raycroft, Jefferies.

（操作員說明）Maury Raycroft，Jefferies。

Hey, good morning. Finished focusing on for Marty. Thank you for taking our questions. So for Peter, can you talk more about the assumptions and key drivers behind you? The revenue guidance of 200 to 200, 200 to $205 million. Then how you had like 231 patient starts and the restart factory, whereas in the same time period last year you had like 274. So just wondering on the assumptions.

嗨，早安。完成了對馬蒂的關注。感謝您接受我們的提問。Peter，您能多談談您背後的假設和關鍵驅動因素嗎？收入指引為200至200、200至2.05億美元。那麼，有 231 名患者啟動並重新啟動工廠，而去年同期有 274 名患者啟動。所以只是想知道這些假設。

Yes. Well, first, on the assumptions to get to the range that we put out there in terms and thank you for your question on guidance factor and as we said, all the elements of our business, right? But obviously we've got a keen eye on the metric that you pull out, which is, you know, what do you what your new starts going into the first quarter and how does that potentially impact the full year view if you look at our PS. PSS year over year, and then you add back in the new starts that we've had in the hospital channel and then you project that on a daily basis towards the end of the quarter. I think what you'll see is that we have on we're experiencing growth, albeit how significant depends on what the continued rate is from now until the end of the quarter, but should project outgrowth to the end of the first quarter versus what we did last year.

是的。好吧，首先，關於達到我們提出的範圍的假設，感謝您提出關於指導因素的問題，正如我們所說，我們業務的所有要素，對吧？但顯然我們對你提出的指標有敏銳的關注，也就是說，你知道，你對第一季的新開始是什麼，如果你看一下我們的數據，這對全年的前景有何潛在影響附言。 PSS 年復一年，然後您將新增回我們在醫院管道中的新開工情況，然後您在季度末每天進行預測。我認為你會看到的是，我們正在經歷成長，儘管成長的顯著程度取決於從現在到本季末的持續成長率，但應該預計到第一季末的成長與我們去年做到了。

So the PSF. a new start number would include all three of those looks quite strong through the first several weeks of the year. And recall also that our March usually lease historically has been one of our best months. So we're we're not even factoring that in the numbers. But if you do factor that in the numbers could significantly contribute to the on to the overall performance but pricing, just to give you the over the overall, we have to continue to see the type of persistency we've seen. We have to see growth in restarts in the hospital channel PSS for sure, time to getting patients on on drug. And of course, the new patient starts that you point out, but it's across all elements. And so far, the first quarter read on those has been strong.

所以PSF。新的起始數據將包括今年前幾週看起來相當強勁的所有三個數據。還要記住，從歷史上看，我們的三月租賃通常是我們最好的月份之一。所以我們甚至沒有將其計入數字中。但如果你確實考慮到數字可能會對整體性能和定價產生重大影響，那麼我們必須繼續看到我們所看到的持久性類型。我們肯定會看到醫院渠道 PSS 重新啟動的數量有所增長，是時候讓患者接受藥物治療了。當然，正如你所指出的，新病人開始了，但它涉及所有因素。到目前為止，第一季的閱讀量一直很強勁。

Makes sense. And then if possible for you to share more insights into the strategic review process, was the apprehension to buy primarily due to the valuation disconnect or something else? And do you think interested parties could come back to negotiate certain likely milestones, commercial sales at IPM?

說得通。然後，如果可能的話，您可以分享更多有關策略審查流程的見解，購買的擔憂主要是由於估值脫節還是其他原因？您認為有興趣的各方可以回來就 IPM 的某些可能的里程碑、商業銷售進行談判嗎？

Well, I listen to the latter part of your question. As we said on the call, we remain open to any and all bona fide on opportunities that are brought forward to the company. I can't speak for other parties nor can I predict the future, but I can tell you that you have a board and a management team that will always remain open to alternative strategies. We don't need to necessarily run a strategic review process. We've always been open to on to our two other opportunities as for feedback to on the specific process, listen, we had a variety of interactions with the parties involved in the strategic review process. And given the nature and the variety and the depth of these interactions as well as the confidential nature of the strategic review process. We can't divulge on additional details at this point. We also can't speak on any other parties' behalf as the information would be material to their business.

好吧，我聽聽你問題的後半部。正如我們在電話會議上所說，我們對向公司提出的任何和所有善意的機會保持開放態度。我不能代表其他方發言，也不能預測未來，但我可以告訴你，你的董事會和管理團隊將始終對替代策略保持開放的態度。我們不一定需要進行策略審查流程。我們一直對另外兩個機會持開放態度，就具體流程提供回饋，聽著，我們與參與策略審查流程的各方進行了各種互動。考慮到這些互動的性質、多樣性和深度，以及策略審查過程的機密性。目前我們無法透露更多細節。我們也不能代表任何其他方發言，因為這些資訊對其業務至關重要。

Thank you for the answers.

謝謝您的回答。

Thanks, busy.

謝謝，忙。

Joseph Schwartz, Leerink Partners.

約瑟夫‧施瓦茨，Leerink Partners。

This is Will on for Joe. Thanks for taking our questions today to from us. So just to start zeroing in on the 101 patients that were restarts, are those from the hospital channel, you provide a breakdown between the two? And do you see this as an area as a potential growth driver for 2024? And are there any kind of appreciable patterns between those patients who are restarting therapy? Thank you.

這是威爾為喬做的事。感謝您今天向我們提出問題。那麼，為了開始關注重新啟動的 101 名患者，這些患者是來自醫院管道嗎？您提供了兩者之間的細目分類嗎？您是否認為該領域是 2024 年的潛在成長動力？那些重新開始治療的患者之間是否有任何明顯的模式？謝謝。

Thanks.

謝謝。

Well, yes, the 101 is referring back to the fourth quarter result that we have when we reported the numerical significance increasing in two channels that we hadn't really historically seen. And that's the patient restarts happening, which we think is a positive signal and then did the opening of the hospital channel and as we've said on the split there in the U.S. And we've got one quarter of a trend here. So this could vary on, but the split, at least in the fourth quarter was more driven. Approximately 75% to 80% of those patients came on a restart basis and about 20% of those patients came out of the hospital as we look at the first several weeks of this quarter so far, we've seen about 40 in the combination. And unfortunately, at least today, I don't have how that break percentage comes across but I would say I would assume it's similar to what we saw in the fourth quarter. We look forward to detailing this as we move forward. And I guess what I'd like to underscore here is that while we'll always continue to report how patient start forms come into the Company, these other channels are going to become more important. And I think going to on a go forward basis, it's going to be very important to look at on net new patients, and that will be inclusive of these restarts that we've kicked out of our overall tracking under PSS and channels like hospitals and other networks that haven't historically been purchasing and well as we always have continued to give transparency in all areas.

嗯，是的，101 指的是我們的第四季度結果，當時我們報告了兩個管道的數值顯著性增加，這是我們歷史上從未真正看到的。這就是病人重新開始發生，我們認為這是一個積極的信號，然後醫院管道開放了，正如我們在美國的分裂中所說的那樣，我們在這裡看到了四分之一的趨勢。因此，情況可能會有所不同，但至少在第四季度的分裂是更加激烈的。大約 75% 到 80% 的患者是在重新開始治療的基礎上康復的，其中大約 20% 的患者出院，從本季度到目前為止的前幾週來看，我們已經看到大約 40 例患者出院。不幸的是，至少在今天，我不知道這個突破百分比是如何體現的，但我想說我會假設它與我們在第四季度看到的類似。我們期待在前進過程中詳細說明這一點。我想我想在這裡強調的是，雖然我們將始終繼續報告患者啟動表格如何進入公司，但這些其他管道將變得更加重要。我認為，在未來的基礎上，關注淨新患者將非常重要，這將包括我們在 PSS 和醫院等管道下從整體追蹤中剔除的這些重新啟動。其他網路歷史上從未進行過購買，並且我們一如既往地繼續在所有領域提供透明度。

Okay. Great. Thank you for that. And then just quickly thinking about the 9% growth in PSSD year over year, but seeing 35% growth in the patients on therapy, if I'm quoting your numbers right. Can you just talk a little bit about the dynamic between the two and how PSS might be a little bit of a leading indicator and kind of a time lag that's associated with that? Thank you.

好的。偉大的。謝謝你。然後快速思考 PSSD 年成長 9%，但如果我引用的數字正確的話，看到接受治療的患者成長了 35%。您能否簡單談談兩者之間的動態以及 PSS 如何成為領先指標以及與之相關的時間滯後？謝謝。

Well, I think there's a couple of things you got to factor in, right? We've never said nor will we say that on new patient starts aren't important to look at. But you know, on the first couple of years of the launch is always a question of how long will patients stay on drug over time and what will the persistency look like? And when patients do eventually come off the drug, do they come back to drug? And we're now starting to understand those dynamics better on. So when you look at overall patient growth and when you look at that relative to new patients coming in, so I think for us, it is somewhat of a it's a forecasting dynamic, right? Like it's the persistency that we've seen. And as reported in this quarter, we've seen improvements in 12 month persistency now above 55% at 56%. And interestingly, when you get to when you get to 18 and then 24 months, we've seen at least up to this point sort of a flattening out of the curve. And I guess I would point to a couple of things new you LAR and could you go guidelines emphasize very clearly that patient should be on medications and this is irregardless of what medication for three to five years on that hasn't been historically helped to how physicians have treated this disease. So on all, Gogo guidelines have been pushing it has been treating episodic sort of flares of proteinuria, and I think those guidelines are helpful.

嗯，我認為有幾件事你必須考慮，對吧？我們從來沒有說過，也不會說，新患者的開始情況並不重要。但你知道，在上市的頭幾年，始終存在一個問題：隨著時間的推移，患者會繼續用藥多久，以及持久性會是什麼樣子？當患者最終停止用藥時，他們還會繼續用藥嗎？我們現在開始更了解這些動態。因此，當您查看整體患者成長以及相對於新患者的情況時，我認為對我們來說，這在某種程度上是一種預測動態，對嗎？就像我們看到的那樣的堅持。正如本季度報告的那樣，我們發現 12 個月的持久性已提高到 55% 以上，達到 56%。有趣的是，當你到了 18 個月，然後是 24 個月時，我們至少看到到目前為止曲線已經趨於平坦。我想我會指出一些新的事情，LAR，你可以去指導方針非常明確地強調患者應該接受藥物治療，無論三到五年的藥物治療歷史上沒有幫助過嗎？醫生已經治療了這種疾病。總而言之，Gogo 指南一直在推動治療陣發性蛋白尿，我認為這些指南很有幫助。

Second, in the last 12 to 18 months, we've launched DIFFERENT on elements of data on that that have crossed a couple of different key areas, one on three year data looking at both safety and efficacy of the product on. So we were first to have data out that far in particular, looking at EGFR, that's an important safety component tracking impact to the kidney and then 18-month biopsy data. So on remember, in 1st year, obviously, we only had the one year or study. So I think all that's impacting. And I think you got to look at persistency alongside of new patient starts and we have to be hitting on both.

其次，在過去的 12 到 18 個月中，我們推出了不同的數據元素，這些數據跨越了幾個不同的關鍵領域，其中一項是三年數據，著眼於產品的安全性和有效性。因此，我們首先獲得了到目前為止的數據，特別是 EGFR，這是一個重要的安全組成部分，追蹤對腎臟的影響，然後是 18 個月的活檢數據。所以請記住，在第一年，顯然，我們只有一年的學習時間。所以我認為所有這些都會產生影響。我認為你必須在新患者開始治療的同時考慮持久性，我們必須兼顧兩者。

Great. Thanks again.

偉大的。再次感謝。

Thank you.

謝謝。

Stacy Ku, Cowen.

史黛西·庫，考恩。

Thanks for taking our questions. So we had a few. So I understand that you can't divulge too many details. But if we could just a quick follow up on an earlier question on strategic review. If you could at least on self critique, what do you think could be the best explanation following the strategic review? Do you think it could be related to something like IP. competitors coming on marketing and have traction with patient adds to some commentary from yourself would be really helpful. Thank you so much, Sam.

感謝您回答我們的問題。所以我們有一些。所以我理解你不能透露太多細節。但我們是否可以快速跟進先前有關策略審查的問題。如果您至少可以進行自我批評，那麼您認為策略審查之後最好的解釋是什麼？你認為這可能與IP之類的東西有關嗎？競爭對手的行銷活動以及對患者的吸引力加上您自己的一些評論將會非常有幫助。非常感謝你，山姆。

I repeat myself, but because of the confidential nature of the strategic review process. There's a limit to the details that we can provide, particularly when it comes to other parties, business decisions and how they saw things. So we can't speak to the or another party's behalf as information could be material to their business.

我重複一遍，但因為戰略審查過程的機密性。我們可以提供的細節是有限的，特別是當涉及其他方、業務決策以及他們如何看待事物時。因此，我們無法代表該方或另一方發言，因為資訊可能對其業務至關重要。

Okay. Understood. And then as you talk about kind of these patient restarts and as you think about kind of long term, do you think this could really help improvements in retention? And then a quick follow-up on kind of your kind of conversion rates for this year. And next year, do you expect to still stick around that 85% to 90% level, or do you think that could continue to improve? Thank you.

好的。明白了。然後，當您談論這些患者的重新啟動以及您對長期的考慮時，您認為這真的有助於提高保留率嗎？然後快速跟進今年的轉換率。明年，您預計仍會保持在 85% 至 90% 的水平嗎？或者您認為這種情況會繼續改善嗎？謝謝。

Starting with the for the last question first, I think the 85 has been fairly consistent while we've seen quarter to quarter or a percentage point or two on directionally up or down, it's been on average pretty consistent. So I would hold that fairly consistent in terms of conversions. I know I I still think we have opportunity to continue to increase speed on and time to conversion to getting patients on drug. So I do think that that's one that we can continue to work on. Even though we're at a fairly high level, getting 60% of patients on to north of 60% of patients on the drug within 20 days. And then the persistency thing, if you look at them, the market research data, we have and the claims data that we have internally, and they show a pretty wide disconnect between what actually happens with patients in the market and where the guidelines are pushing things to go to in terms of two elements, three, actually, one is diagnosis. We know that SLE patients have a low percentage, actually get a 24 hour urine screen when they come into a doc's office. We need to continue to improve on that. That will grow the market second on top treating to target second. So we know from our data that there's a that there's a proportion of physicians actually who only treat to high proteinuria above what the current guidelines recommend in terms of proteinuria level that would qualify a patient as having active lupus nephritis, so getting active treatment and treatment to target our key opportunities and goals for us.

首先從最後一個問題開始，我認為 85 相當一致，雖然我們看到季度與季度之間或一個或兩個百分點的方向向上或向下，但平均而言相當一致。所以我認為在轉換方面相當一致。我知道我仍然認為我們有機會繼續加快患者用藥的速度和時間。所以我確實認為這是我們可以繼續努力的一個。儘管我們處於相當高的水平，但在 20 天內讓 60% 的患者接受了超過 60% 的患者的藥物治療。然後是持久性問題，如果你看一下我們擁有的市場研究數據和我們內部擁有的索賠數據，它們顯示出市場上患者實際發生的情況與指南所推動的情況之間存在相當大的脫節要做的事情有兩個要素，三個，實際上，一個是診斷。我們知道，系統性紅斑狼瘡患者在進入醫生辦公室時實際上接受 24 小時尿液篩檢的比例很低。我們需要在這方面繼續改進。這將使排名第二的市場成長到排名第二的目標。因此，從我們的數據中我們知道，有一部分醫生實際上只治療高蛋白尿，其蛋白尿水平高於當前指南建議的蛋白尿水平，使患者有資格患有活動性狼瘡腎炎，因此要積極治療和治療為我們鎖定關鍵機會和目標。

And then lastly, there's this element of physicians treating on episodic proteinuria versus sticking to guidelines and treating for and keeping those patients in control for at least three to five years, which we think obviously it bodes well for continuing to see at least stabilization if not improvement in our persistency rates our past 12 months, 24 and 24 months on. So all of those elements, I think when you look at the data, we have aligned with the guidelines and the market opportunity bodes well for our growth in the future. Thank you, NxStage.

最後，醫生治療陣發性蛋白尿與堅持指導方針並治療並使這些患者保持控制至少三到五年，我們認為這顯然是一個好兆頭，如果不是的話，這至少是穩定的好兆頭過去12 個月、24 個月和24 個月，我們的堅持率有所提高。因此，我認為，當您查看數據時，所有這些要素都已與指導方針保持一致，並且市場機會預示著我們未來的成長。謝謝你，NxStage。

Ed Arce, H.C. Wainwright & Co.

埃德·阿爾塞，H.C.溫賴特公司

Thanks for taking my questions. I have three. First, I wanted to ask about the share repurchase. Tom, if you could you tell us what expectations you have for the time line on the decision for exemptive relief? And is that something if that decision comes in?Is that something that you would announce publicly and.

感謝您回答我的問題。我有三個。首先我想問一下關於股票回購的問題。湯姆，您能否告訴我們您對豁免救濟決定的時間表有何期望？如果做出決定的話，這會是什麼事嗎？這是你會公開宣布的事情嗎？

Why don't I start and if I miss anything, Joe can jump in here on the exemptive relief. I don't know that we have an exact time line for when we'll get on a read back from the Canadian authorities on that. But without the exemptive relief, we have up to 5% and 5% of our market cap that we have the ability to initiate Tom without that exactly that exemptive relief. So as mentioned on the call on at or around the 21st of February is when we would have the ability to on the market if we so chose. And at that point, we would not need the executive exemptive relief to at least do up to 5% of our market cap after that would be how we expand above if we get that exemptive relief. Joe, did I miss anything to answer your second question around that add-on? We would also announce that exemptive relief was granted and if and when it was granted.

我為什麼不開始，如果我錯過了什麼，喬可以跳到這裡享受豁免救濟。我不知道我們何時收到加拿大當局的回覆有確切的時間表。但如果沒有豁免減免，我們有高達 5% 和 5% 的市值，我們有能力在沒有豁免減免的情況下啟動 Tom。因此，正如我們在 2 月 21 日左右的電話會議上所提到的，如果我們選擇的話，我們將有能力上市。到那時，我們不需要行政豁免減免，至少可以達到我們市值的 5%，之後如果我們獲得豁免減免，我們將如何擴大這一範圍。喬，我是否錯過了回答您關於該附加組件的第二個問題的任何內容？我們還將宣布已授予豁免救濟以及是否授予以及何時授予。

Okay. Sorry. Secondly, just in terms of the growth drivers, you have been consistent over a number of quarters and how on educating physicians and activating the patient is really critical here. And I'm wondering, as you work through the dynamic of this on market in getting both patients and physicians Even more importantly, changing the paradigm of the way they treat. And maybe talk about some of the more recent wins that you see and changes in attitudes and perspectives. What is currently working right now?

好的。對不起。其次，就成長動力而言，您在幾個季度中一直保持一致，如何教育醫生和激活患者在這裡非常關鍵。我想知道，當您研究市場上的動態時，讓患者和醫生更重要的是，改變他們治療方式的範式。也許可以談談您最近看到的一些勝利以及態度和觀點的變化。目前正在做什麼？

Well, as we mentioned on the call, although we didn't give the exact numbers, I can tell you, we've seen significant improvement in both depth of prescriptions and bread, the prescriptions. So we're going deeper and we're going wider in. So I think our ability to impact our eight to 10 deciles, our sales force's ability has been there. And even in addition, the broader message of more aggressive treatment, novel therapies like Leukine is getting out to the broader base of physicians on.

嗯，正如我們在電話中提到的，雖然我們沒有給出確切的數字，但我可以告訴你，我們已經看到處方和麵包的深度都有顯著改善。所以我們要走得更深、更廣。因此，我認為我們有能力影響 8 到 10 個十分位，而我們的銷售人員的能力已經存在。此外，更積極的治療、白細胞介素等新型療法的更廣泛訊息正在向更廣泛的醫生群體傳播。

Well, I would also point to add the progress that we've seen on persistency on both with improvements at at 12 months and sort of a stabilization out to 18 and 24 months. I think those are both directly correlated to on the data that's been out that we put into the marketplace that we produce through the extension study and through the biopsy extension as well or the biopsy substudy and on our commercial execution on, we'll look forward to continuing to sharpen the edges of those results with more specifics. But I can tell you there's been progress on every front Okay, great.

好吧，我還想補充一下我們在持久性方面所看到的進展，在 12 個月時有所改善，在 18 個月和 24 個月時有所穩定。我認為這些都與我們透過擴展研究和活檢擴展或活檢擴展或活檢投入市場產生的數據以及我們的商業執行直接相關，我們將期待繼續用更多細節來磨礪這些結果的邊緣。但我可以告訴你，各方面都取得了進展，好吧，太棒了。

And then last question, if I may. Given the streamlined focus here on commercial execution of Leukine is, I'm wondering, you know, post the reduction in cost structure and headcount as you look towards the second half of the year, could you perhaps share any commentary on achieving near term profitability, any growth, profit growth and profitability over time?

最後一個問題，如果可以的話。鑑於這裡對 Leukine 商業執行的簡化重點是，我想知道，在展望今年下半年時發布成本結構和員工人數的減少，您能否分享有關實現近期盈利能力的任何評論隨著時間的推移，有任何成長、利潤成長和獲利能力嗎？

Yes, you want to jump on that, Joe. Sure, Tom?

是的，你想抓住這一點，喬。當然可以，湯姆？

Yes, thanks, Ed. We as you know, we don't provide long-term guidance. We've indicated that on an annualized operating expense basis, we'd cut about 55 to 60 per $60 million on over the next 12 months, of which approximately 75% of that will be recognized in at least 2024. On we do believe that with these reduced operating expenses and our focus on commercial execution behind this growth, specifically, we expect significant cash flows going forward.

是的，謝謝，艾德。如您所知，我們不提供長期指導。我們已經表示，按照年化營運費用計算，我們將在未來 12 個月內每 6000 萬美元削減約 55 至 60 美元，其中約 75% 至少將在 2024 年得到確認。我們確實相信具體來說，隨著營運費用的減少以及我們對成長背後的商業執行的關注，我們預計未來會有大量現金流。

On an on a go-forward basis, we will we obviously update you going forward on profitability. Some of this is tied to the timing around the restructuring charge as well as on the share buyback plan. So further further insights will come in the future. But for now, we've kind of guided to a 55 to $60 million OpEx savings on an annualized basis.

在未來的基礎上，我們顯然會向您通報未來獲利能力的最新情況。其中一些與重組費用以及股票回購計劃的時間表有關。因此，未來將會有進一步的見解。但目前，我們的目標是每年節省 5,500 至 6,000 萬美元的營運支出。

Great. Fair enough. Thanks for taking my question.

偉大的。很公平。感謝您提出我的問題。

Thanks, Ed.

謝謝，艾德。

Thank you. We have reached the end of the question and answer session, and I'll now turn the call back over to Peter Greenleaf for closing remarks.

謝謝。我們的問答環節已經結束，現在我將把電話轉回給彼得·格林利夫（Peter Greenleaf）做總結演講。

Thank you very much. I want to thank everybody for their time today, and we look forward to coming up on future quarters, reporting our results and keeping you updated on our plans. Thank you very much for joining us today. Have a great day.

非常感謝。我要感謝大家今天抽出時間，我們期待在未來幾季報告我們的結果並向您通報我們的計劃的最新情況。非常感謝您今天加入我們。祝你有美好的一天。

This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，您現在可以掛斷電話了。感謝您的參與。