Aurinia Pharmaceuticals Inc (AUPH) 2024 Q3 法說會逐字稿

Greetings and welcome to Aurinia Pharmaceutical third quarter, 2024 earnings call. (Operator Instructions). As a 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 Pharmaceutical. Thank you. You may now begin.

歡迎參加 Aurinia Pharmaceutical 2024 年第三季財報電話會議。（操作員說明）。提醒一下，本次會議正在錄製中。現在我想將會議交給主持人 Aurinia Pharmaceutical 企業傳播和投資者關係主管 Andrea Christopher。謝謝。你現在可以開始了。

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 President and Chief Executive Officer; Joe Miller, our Chief Financial Officer; and Dr. Greg Keenan, our Chief Medical Officer. Today we will review and discuss Aurinia's 2024 third quarter financial and operational results as communicated in the company's press release issued this morning.

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還有 Aurinia 總裁兼執行長 Peter Greenleaf；喬‧米勒，我們的財務長；以及我們的首席醫療官 Greg Keenan 博士。今天，我們將回顧和討論 Aurinia 今天上午發布的公司新聞稿中傳達的 2024 年第三季財務和營運績效。

The company also filed its quarterly financial statements on form 10-Q this morning. For more information, please refer to Aurinia's filings with the US Securities and Exchange Commission and Canadian Securities authorities, which are also available on Aurinia's website at auriniapharma.com.

該公司今天上午還提交了 10-Q 表格的季度財務報表。欲了解更多信息，請參閱 Aurinia 向美國證券交易委員會和加拿大證券監管機構提交的文件，這些文件也可以在 Aurinia 的網站 auriniapharma.com 上找到。

During today's call Aurinia 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.

在今天的電話會議中，Aurinia 可能會根據當前的預期做出前瞻性聲明。這些前瞻性陳述面臨許多重大風險和不確定性，實際結果可能有重大差異。

For a discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in Aurinia's press release, its quarterly report on form 10-Q, 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.

有關可能影響 Aurinia 未來財務表現和業務的因素的討論，請參閱 Aurinia 新聞稿、10-Q 表格季度報告、10-K 表格年度報告以及所有最近提交的文件中的披露內容與美國證券交易委員會和加拿大證券當局。

Please note that all statements made during today's call are current as of today, November 7, 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?

請注意，除非另有說明，否則今天電話會議中發表的所有聲明均截至今天（2024 年 11 月 7 日），且均基於我們目前掌握的資訊。除法律要求外，Aurinia 不承擔更新任何此類聲明的義務。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 the call today. On this morning's call, I'll provide the details on our third quarter business metrics and how we are preparing for the rest of the year. I'll 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。我要感謝大家今天加入我們的電話會議。在今天早上的電話會議上，我將提供有關我們第三季業務指標以及我們如何為今年剩餘時間做好準備的詳細資訊。然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。

With continued focus on commercial execution, we achieved a strong third quarter performance. For the third quarter of 2024, Total net revenue was $67.8 million compared to $54.5 million for the same period in 2023, representing a 24% growth. For the first nine months of 2024, total net revenue was $175.3 million compared to $130.4 million for the same period in 2023, representing 34% growth.

透過持續關注商業執行，我們取得了強勁的第三季業績。2024 年第三季度，總淨收入為 6,780 萬美元，較 2023 年同期的 5,450 萬美元成長 24%。2024 年前 9 個月，總淨收入為 1.753 億美元，而 2023 年同期為 1.304 億美元，成長 34%。

For the third quarter of 2024, net product revenue was $55.5 million compared to $40.8 million for the same period in 2023, representing 36% growth. For the first nine months of 2024, net product revenue was $158.6 million compared to 116.2 million for the same period in 2023 this representing 36% growth.

2024 年第三季度，產品淨收入為 5,550 萬美元，而 2023 年同期為 4,080 萬美元，成長 36%。2024 年前 9 個月，產品淨收入為 1.586 億美元，而 2023 年同期為 1.162 億美元，成長 36%。

The company generated approximately $17 million in cash flow from operations in the third quarter, reflecting continued strong operational execution and further strengthening of our financial position. The company had cash, cash equivalents, restricted cash and investments at $348.7 million as of September 30, 2024.

該公司第三季的營運現金流量約為 1,700 萬美元，反映出持續強勁的營運執行力以及我們財務狀況的進一步加強。截至 2024 年 9 月 30 日，該公司的現金、現金等價物、限制性現金和投資為 3.487 億美元。

In terms of commercial performance and metrics for the third quarter, we added 364 PSFs and 146 new patients who were either restarting LUPKYNIS or receiving it through the hospital pharmacy. Together these totaled 510 compared to 436 PSFs in the prior year third quarter, representing 17% year-over -year growth. We also achieved 25% growth in total patients on LUPKYNIS therapy with approximately 2,422 patients on therapy as of September 30, 2024. This compared to 1,939 patients as of September 30, 2023.

就第三季的商業表現和指標而言，我們增加了 364 名 PSF 和 146 名新患者，他們要么重新啟動 LUPKYNIS，要么透過醫院藥房接受治療。與去年第三季的 436 個 PSF 相比，這些總數總計 510 個，年增 17%。截至 2024 年 9 月 30 日，接受 LUPKYNIS 治療的患者總數也實現了 25% 的增長，約有 2,422 名患者接受治療。相較之下，截至 2023 年 9 月 30 日，共有 1,939 名患者。

This significant year-over-year growth was driven by patients restarting LUPKYNIS after being off therapy for an extended period of time, as well as hospital fills and maintaining high persistency rates year-over-year. we're encouraged by the continued increase in our persistency rates across all time periods and that our rapid conversion time and overall conversion and adherence rates remain consistent and consistently at high levels.

這一顯著的同比增長是由於患者在較長時間停止治療後重新開始 LUPKYNIS 治療，以及醫院的填充率和同比保持高持續率而推動的。我們對所有時間段的持續率持續增長感到鼓舞，並且我們的快速轉換時間以及整體轉換率和堅持率保持一致並始終處於高水準。

Finally, we're off to a strong fourth quarter start, and we're looking forward to communicating those results next year when we report full year results. As a result of our strong commercial performance, we're reiterating our net product revenue guidance range of $210 million to $220 million.

最後，我們第四季的開局強勁，我們期待明年報告全年業績時公佈這些結果。由於我們強勁的商業業績，我們重申我們的淨產品收入指引範圍為 2.1 億至 2.2 億美元。

In summary, we're very pleased with our net revenue and cash flow from operations figures for the quarter, which represent record performance for the company.

總之，我們對本季的淨收入和營運現金流數據感到非常滿意，這代表了公司創紀錄的業績。

We also achieved several very important milestones in the third quarter. We announced that the first participant has been dosed in a Phase 1 study of AUR200, our BAFF/APRIL dual antagonist for autoimmune disorders. We look forward to sharing initial results from this study and advancing clinical developments into 2025.

我們在第三季也實現了幾個非常重要的里程碑。我們宣布，第一位參與者已在 AUR200 的 1 期研究中接受給藥，AUR200 是我們用於治療自體免疫疾病的 BAFF/APRIL 雙重拮抗劑。我們期待分享這項研究的初步結果，並將臨床開發推進到 2025 年。

We also announced that Japanese regulatory authorities approved LUPKYNIS to treat Lupus nephritis, triggering the recognition of an additional $10 million milestone payment in the quarter.

我們也宣布日本監管機構批准 LUPKYNIS 治療狼瘡性腎炎，觸發本季額外 1,000 萬美元里程碑付款的確認。

The company anticipates low double digit royalties on net sales once LUPKYNIS is launched in Japan. our successful partnership with Otsuka has allowed us to bring LUPKYNIS to Lupus nephritis patients across Europe and now Japan, where there's a high rate of lupus nephritis.

該公司預計，一旦 LUPKYNIS 在日本推出，淨銷售額的特許權使用費將達到兩位數。我們與大塚的成功合作使我們能夠將 LUPKYNIS 帶給歐洲和現在狼瘡性腎炎發病率很高的日本的狼瘡性腎炎患者。

Additionally, there were five presentations on LUPKYNIS at the recent American Society of Nephrology Kidney Week meeting. These presentations describe the critical role LUPKYNIS plays in advancing the treatment of lupus nephritis, especially in populations disproportionately impacted by the disease.

此外，在最近的美國腎臟病學會腎臟週會議上，還有五場關於 LUPKYNIS 的演講。這些演講描述了 LUPKYNIS 在推進狼瘡性腎炎治療中所發揮的關鍵作用，特別是在受疾病影響不成比例的人中。

An analysis of baseline data from the ENLIGHT-LN registry provided important insights into real world treatment patterns. Data were also presented, supporting a growing body of evidence that LUPKYNIS through a unique mechanism of action, favourably affects Podocytes, which in turn should improve kidney health in adults with active lupus nephritis.

對 ENLIGHT-LN 註冊中心基線數據的分析為了解現實世界的治療模式提供了重要見解。也提供了數據，支持越來越多的證據表明 LUPKYNIS 透過獨特的作用機制對足細胞產生有利影響，這反過來又應該改善患有活動性狼瘡腎炎的成年人的腎臟健康。

Now let me shift gears and discuss today's announcement that we are restructuring our operations to sharpen our commercial and R&D efforts. Our goal through this initiative is to implement a highly focused industry-leading operational strategy that will enable us to lean further into key areas of the commercial LUPKYNIS business that have historically delivered optimal returns by accelerating clinical development of AUR200.

現在讓我換個話題，討論一下今天宣布的我們正在重組業務以加強我們的商業和研發工作的公告。我們透過這項措施的目標是實施高度集中的行業領先營運策略，使我們能夠進一步深入商業 LUPKYNIS 業務的關鍵領域，這些領域歷來透過加速 AUR200 的臨床開發提供了最佳回報。

We also expect the restructuring to further strengthen our balance sheet. Going forward, our targeted commercial strategy for LUPKYNIS will allow us to lean further into key areas of business that have historically been our highest growth drivers.

我們也預計重組將進一步加強我們的資產負債表。展望未來，我們針對 LUPKYNIS 的商業策略將使我們能夠進一步深入到歷來是我們最高成長動力的關鍵業務領域。

As part of the restructuring, we will be reducing our workforce by approximately 45%. We anticipate that this initiative will further improve operational efficiency with anticipated post restructuring annualized cash-based operating expense savings of more than $40 million. This initiative will further strengthen our financial position and provide more flexibility to engage in future business building activities.

作為重組的一部分，我們將裁員約 45%。我們預計這項措施將進一步提高營運效率，預計重組後年度現金營運費用節省將超過 4,000 萬美元。這項舉措將進一步加強我們的財務狀況，並為參與未來的業務建設活動提供更大的靈活性。

I'd like to now turn the call over to Joe Miller, our CFO, for a more detailed review of our financial results. I'll then return at the end of the call for a quick recap and open up the line and any questions you might have. Joe?

我現在想將電話轉給我們的財務長喬·米勒 (Joe Miller)，以更詳細地審查我們的財務業績。然後，我將在通話結束時回來進行快速回顧，並打開線路並詢問您可能有的任何問題。喬？

Thank you, Peter, and good morning, everyone. Let's take a few minutes and go into detail regarding our financial results for the third quarter and nine months ended September 30, 2024.

謝謝你，彼得，大家早安。讓我們花幾分鐘時間詳細了解我們截至 2024 年 9 月 30 日的第三季和九個月的財務表現。

As of September 30, 2024, we had cash, cash equivalents, restricted cash and investments of $348.7 million compared to $350.7 million as of December 31, 2023, and $330.7 million as of June 30, 2024, The change from the year-end balance is primarily related to the continued investment in commercialization activities and post-approval commitments of LUPKYNIS, monoplant payments, share repurchases, and restructuring-related payments, offset by an increase in cash receipts from LUPKYNIS sales and cash payments from Otsuka.

截至2024年9月30日，我們的現金、現金等價物、限制性現金和投資為3.487億美元，而截至2023年12月31日為3.507億美元，截至2024年6月30日為3.307億美元，與年末餘額的變化主要與對 LUPKYNIS 商業化活動和批准後承諾的持續投資、單一工廠付款、股份回購和重組相關付款有關，但被 LUPKYNIS 銷售現金收入和大塚公司現金支付的增加所抵消。

The increase in the balance over prior quarter is due to cash receipts from LUPKYNIS sales and cash payments from Otsuka, partially offset by commercialization activities, monoplant payments, and inventory purchases.

餘額較上季增加的原因是 LUPKYNIS 銷售的現金收入和大塚的現金支付，部分被商業化活動、單一工廠付款和庫存採購所抵消。

Cash flow generated by operations was $17 million for the three months ended, September 30, 2024, compared to $13.3 million in cash flow used for the three months ended September 30, 2023. Cash flow generated by operations was $14.3 million for the nine months ended September 30, 2024, compared to $47.8 million in cash flow used for the nine months ended September 30, 2023.

截至2024年9月30日止三個月，營運產生的現金流量為1,700萬美元，截至2023年9月30日止三個月，營運產生的現金流量為1,330萬美元。截至2024年9月30日的九個月，營運產生的現金流為1,430萬美元，而截至2023年9月30日的九個月，營運產生的現金流為4,780萬美元。

Total net revenue was $67.8 million for the three months ended September 30,2024, and $54.5 million for the same period in 2023. Year-to-date, total net revenue was $175.3 million for the nine months ended September 30, 2024, compared to $130.4 million for the same period in 2023. Net product revenue was $55.5 million for the three months ended September 30, 2024, and $40.8 million for the same period in 2023. Net product revenue was $158.6 million for the nine months ended September 30,2024, and $116.2 million for the same period in 2023. The increase in both periods is primarily due to increased LUPKYNIS sales to the company's two main specialty pharmacies, driven predominantly by further penetration of the market.

截至 2024 年 9 月 30 日的三個月淨收入總額為 6,780 萬美元，2023 年同期淨收入總額為 5,450 萬美元。年初至今，截至 2024 年 9 月 30 日的九個月淨收入總額為 1.753 億美元，而 2023 年同期為 1.304 億美元。截至 2024 年 9 月 30 日的三個月，產品淨收入為 5,550 萬美元，2023 年同期為 4,080 萬美元。截至2024年9月30日的九個月，產品淨收入為1.586億美元，2023年同期為1.162億美元。這兩個時期的成長主要是由於 LUPKYNIS 向該公司兩家主要專業藥房的銷售額增加，這主要是由市場的進一步滲透所推動的。

Additionally, for the nine months ended September 30,2024, Aurinia had sales of semi-finished product to Otsuka as Otsuka continues to commercialize in its territories.

此外，截至 2024 年 9 月 30 日的九個月中，隨著大塚繼續在其領土上進行商業化，Aurinia 向大塚銷售了半成品。

License, collaboration, and royalty revenue was $12.3 million and $13.7 million for the three months ended September 30, 2024, and September 30,2023 respectively, and $16.7 million and $14.2 million for the nine months ended September 30,2024, and September 30, 2023, respectively. The revenue is primarily due to a $10 million milestone recognized in the third quarter of 2024 for the Japanese Ministry of Health, Labor and Welfare approval of LUPKYNIS and a $10 million milestone recognized in the third quarter of 2023 for pricing and reimbursement approval coupled with manufacturing services revenue for Otsuka related to the shared capacity services that commenced in late of June 2023.

截至2024年9月30日和2023年9月30日的三個月的許可、合作和特許權使用費收入分別為1,230萬美元和1,370萬美元，截至2024年9月30日和2023年9月30日的九個月分別為1,670萬美元和1,420萬美元。該收入主要歸因於 2024 年第三季日本厚生勞動省批准 LUPKYNIS 實現了 1000 萬美元的里程碑，以及 2023 年第三季定價和報銷批准以及製造方面實現了 1000 萬美元的里程碑大塚的服務收入與2023 年6 月下旬開始的共享容量服務有關。

Cost of sales were $6 million and $6.8 million for the three months ended September 30,2024 and September 30, 2023, and $22.7 million and $8.8 million for the nine months ended September 30, 2024, and September 30, 2023, respectively. The increase for the nine-month period is primarily due to the amortization of the monoplant finance right-of-use-asset, which was placed in the service in late June 2023 and therefore, only partially impacting prior year results.

截至2024年9月30日和2023年9月30日的三個月的銷售成本分別為600萬美元和680萬美元，截至2024年9月30日和2023年9月30日的九個月的銷售成本分別為2,270萬美元和880萬美元。這九個月期間的成長主要是由於單一融資使用權資產的攤銷，該資產於 2023 年 6 月下旬投入服務，因此僅部分影響上一年的業績。

Gross margin for the three months ended September 30, 2024, was 91% compared to 88% for the three months ended September 30, 2023. Gross margin for the nine months ended September 30, 2024, was 87% compared to 93% for the nine months ended September 30, 2023.

截至2024年9月30日止三個月的毛利率為91%，而截至2023年9月30日止三個月的毛利率為88%。截至2024年9月30日止九個月的毛利率為87%，而截至2023年9月30日止九個月的毛利率為93%。

SG&A expenses, inclusive of share-based compensation, were $42.4 million and $47.8 million for the three months ended September 30, 2024, and September 30, 2023, respectively. SG&A expenses inclusive of share-based compensation were $135 million for the nine months ended September 30, 2024, compared to $145 million for the same period ended September 30, 2023.

截至2024年9月30日及2023年9月30日的三個月，SG&A費用（含股權激勵）分別為4,240萬美元及4,780萬美元。截至2024年9月30日止九個月，包括股權激勵在內的SG&A費用為1.35億美元，而截至2023年9月30日同期為1.45億美元。

The decrease in both periods is primarily due to lower employee-related costs, including share-based compensation and overhead as a result of reduction in general and administrative headcount, which occurred late in the 1st quarter of 2024.

這兩個時期的下降主要是由於與員工相關的成本下降，包括基於股份的薪酬和由於 2024 年第一季末一般和行政人員減少而產生的管理費用。

Research and development expenses, inclusive of share-based compensation were $3 million for the three months ended September 30, 2024, compared to $13.6 million for the three months ended September 30, 2023. R&D expenses inclusive of share-based compensation was $12.7 million and $39.4 million for the nine months ended September 30, 2024, and September 30, 2023, respectively.

截至2024年9月30日止三個月的研發費用（包括股權激勵）為300萬美元，截至2023年9月30日止三個月為1,360萬美元。截至2024年9月30日及2023年9月30日的九個月，包括股權激勵在內的研發費用分別為1,270萬美元及3,940萬美元。

The primary drivers for the decrease in both periods were lower employee costs related to a reduction in headcount, which occurred late in the first quarter of 2024, a decrease of expenses related to ceasing Aurinia's AUR300 Development Program and the timing of expenses related to developing AUR200.

這兩個時期下降的主要驅動因素是與人員減少相關的員工成本降低（發生在 2024 年第一季末）、與停止 Aurinia 的 AUR300 開發計劃相關的費用減少以及與開發 AUR200 相關的費用時間表。

For the three months ended September 30, 2024, Aurinia recorded a net income of $14.4 million or $0.10 net income per common share, as compared to a net loss of $13.4 million or $0.09 net loss per common share for the three months ended September 30, 2023.

截至2024 年9 月30 日的三個月，Aurinia 的淨收入為1,440 萬美元，或每股普通股淨收入0.10 美元，而截至9 月30 日止的三個月，淨虧損為1,340 萬美元，或每股普通股淨虧損0.09 美元， 2023 年。

For the nine months ended September 30, 2024, Aurinia recorded net income of $4.3 million or $0.03 net income per common share, as compared to a net loss of $51.1 million or $0.36 net loss per common share, for the nine months ended September 30, 2023. With that, I'd like to hand the call back over to Peter for some closing remarks, Peter?

截至2024 年9 月30 日的九個月，Aurinia 錄得淨利430 萬美元或每股普通股淨收入0.03 美元，而截至9 月30 日的九個月淨虧損為5,110 萬美元或每股普通股淨虧損0.36 美元。說到這裡，我想把電話轉回給 Peter 做總結發言，Peter？

Thanks, Joe. We're looking forward to a strong finish for 2024 and heading into 2025 with a highly efficient organization focused on LUPKYNIS growth and advancing AUR200. I want to thank you all for your time today. We'll now open the lines for any questions you might have. operator?

謝謝，喬。我們期待著一個專注於 LUPKYNIS 成長和推進 AUR200 的高效組織在 2024 年取得強勁的成績，並進入 2025 年。我要感謝大家今天抽出寶貴的時間。我們現在將開通熱線詢問您可能有的任何問題。操作員？

(Operator Instructions) Stacy Ku, TD Cowen.

（操作員說明）Stacy Ku，TD Cowen。

Thanks so much for taking our questions. So, we wanted to ask a few more questions on the restructuring. Is it based on what you're seeing in Q3, Q4, or are you signalling confidence in your competitive positioning for AUR200? So just help us understand the PSFs that you saw in Q3, your view on the patient restarts in hospital capture, what's the growth driver in the future? And then the reason for the restructuring. So that's the first question. And then for follow-up for a AUR200, can you just talk about what exactly you plan to disclose after the Phase 1 single-ascending dose? And what kind of disclosures you might expect?

非常感謝您回答我們的問題。因此，我們想就重組提出更多問題。是基於您在第三季、第四季看到的情況，還是您對 AUR200 的競爭定位充滿信心？所以請幫助我們了解您在第三季度看到的 PSF，您對醫院捕獲中患者重新啟動的看法，未來的成長動力是什麼？然後是重組的原因。這是第一個問題。然後，對於 AUR200 的後續行動，您能否談談在第一階段單次劑量遞增之後您到底計劃披露什麼？您可能期望得到什麼樣的揭露？

Stacy, first off, thank you, and there were multiple questions in there. So why don't I try to dissect them one at a time, and then if I miss on any of them, please come back to me. The first is on the restructuring. So, over the last, let's call it, 60 to 90 days, we've taken a very aggressive review of the primary drivers of our business, focus of the organization and the things that we believe are driving growth and value the organization, intrinsically, and of course, hopefully, accruing over time to the share price.

史黛西，首先，謝謝你，其中有很多問題。那麼，為什麼我不嘗試一次剖析它們，然後如果我錯過其中任何一個，請回到我身邊。首先是關於重組。因此，在過去的 60 到 90 天裡，我們對業務的主要驅動因素、組織的重點以及我們認為從本質上推動組織成長和價值的事物進行了非常積極的審查，當然，希望隨著時間的推移，股價會上漲。

And by that, I think we were able to really do a lot of work that we're able to point us in the direction of what those drivers would be. So, this is in no way a signalling that we don't have confidence in the business. We are confirming 2024 guidance. We're not giving 2025 guidance today, but this should in no way be interpreted as a slowing down of the growth. We actually think by this focusing, we can continue to grow the compound at the rate we've seen or even better.

透過這一點，我認為我們確實能夠做很多工作，為我們指明這些驅動因素的方向。因此，這絕不顯示我們對這項業務沒有信心。我們正在確認 2024 年指導。我們今天不會給出 2025 年的指引，但這絕不應該被解釋為成長放緩。實際上，我們認為透過這種關注，我們可以繼續以我們所看到的速度甚至更好的速度生產化合物。

Moving forward, if you look at the PSFs question, I think at least our interpretation internally is PSFs have moved from where we were in quarter three last year, just having PSFs to today, it being a combination of PSFs product coming out of the hospital, which we try to interpret to a patient, but we have ships in most cases that are going into the hospital and then the restarts in our business.

展望未來，如果你看看 PSF 問題，我認為至少我們內部的解釋是 PSF 已經從去年第三季度的狀態發生了變化，今天只有 PSF，它是醫院出來的 PSF 產品的組合，我們試圖向患者解釋這一點，但在大多數情況下，我們有船隻進入醫院，然後重新啟動我們的業務。

And those three in combination, along with strong persistency that we've driven from the, from the follow-up AURORA trials, that the 3-year data that we had through AURORA are all helping to continue to drive the compound. So, we're not deemphasizing PSFs, but I think you need to look in total at the PSFS in combination with restarts in our business, which are growing every quarter more and more in the hospital-based business. And since that number did become reflected in Q4 last year, we'll be able to give like-to-like growth numbers of both PSFs, hospitals, and restarts Q4 to Q4 when we report the fourth quarter.

這三者結合起來，加上我們從後續 AURORA 試驗中獲得的強大持久性，我們透過 AURORA 獲得的 3 年數據都有助於繼續推動該化合物的發展。因此，我們並不是不重視 PSF，但我認為您需要結合我們業務的重啟來全面審視 PSFS，在醫院業務中，PSFS 每個季度都在成長。由於這一數字確實反映在去年第四季度，因此當我們報告第四季度時，我們將能夠提供 PSF、醫院和重新啟動的第四季度至第四季度的同比增長數據。

Your last question was on a AUR200. And what we expect to actually present as we move in. We'll have the single-ascending dose and the multi-ascending dose trials that we're working on reading out next year. Obviously, there'll be the Pharmacokinetic profile of the drug that we'll get from that. And of course, any relevant biomarker work that you would expect to see coming out of those trials.

您的最後一個問題是關於 AUR200 的。以及我們搬入時期望實際呈現的內容。我們將在明年進行單劑量遞增和多劑量遞增試驗。顯然，我們將從中獲得藥物的藥物動力學特徵。當然，您期望從這些試驗中看到任何相關的生物標記工作。

Thank you so much.

太感謝了。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑弗里斯。

Hi, good morning. Congrats on the progress and thanks for taking my question. Maybe just starting with thinking about fourth quarter. Typically, you guys have a heavier fourth quarter in sales. And if you maintain the current run rate, you should be able to hit the midpoint of your guidance comfortably. So, we're just wondering what you're seeing so far in October and if the higher end of guidance is potentially conservative, if you can comment on that.

嗨，早安。恭喜您的進展，並感謝您提出我的問題。也許只是從考慮第四季開始。通常情況下，你們第四季的銷售額會更高。如果您保持當前的運行速度，您應該能夠輕鬆達到指導的中點。因此，我們只是想知道您在 10 月到目前為止所看到的情況以及指導的較高端是否可能保守，您是否可以對此發表評論。

Yeah, I wouldn't overread into us maintaining the guidance range that we have right now. I think we feel comfortable with the range that we put out there. And at this stage, we did bat around whether we change or narrow that range, and we thought it was just a more conservative approach to look at the fourth quarter. The good thing is it lands us right in that guidance range. And if you're looking for anything to point out what might put you on the low end versus the high end, obviously, you have a lot of patients with the year-end insurance changes, et cetera, that kind of moves into the first quarter as well that we'll always work through in the month of December, and you have holidays in November and December. So, we wanted to just make sure that we accounted for those as potential factors as well. But you're not incorrect on the historical, we've seen growth 3Q over 4Q.

是的，我不會過度解讀我們維持目前的指導範圍。我認為我們對我們在那裡推出的產品系列感到滿意。在這個階段，我們確實在考慮是否改變或縮小這個範圍，我們認為這只是看待第四季度的更保守的方法。好處是它使我們處於指導範圍內。如果您正在尋找任何東西來指出什麼可能會讓您處於低端與高端，顯然，您有很多患者接受年終保險變更等等，這種情況會進入第一個階段我們將始終在12 月份完成季度工作，而您在11 月和12 月有假期。因此，我們想確保我們也將這些視為潛在因素。但你對歷史的看法並沒有錯，我們看到第三季的成長超過了第四季。

Got it. That's helpful. And just wondering how the observational registry study, the ENLIGHT-LN study, is providing insights into the real-world lupus nephritis treatment paradigm and how LUPKYNIS is used. And you continue to get a nice uptick in patients restarting LUPKYNIS. Are you getting insights into how the segment is defined and if you can potentially influence and ramp up this effect going forward?

知道了。這很有幫助。只是想知道觀察性註冊研究 ENLIGHT-LN 研究如何提供對現實世界狼瘡性腎炎治療範例以及 LUPKYNIS 如何使用的見解。重新啟動 LUPKYNIS 的患者數量持續大幅增加。您是否深入了解了該細分市場的定義方式以及未來是否有可能影響和增強這種影響？

I'm going to turn some of this over to Dr. Greg Keenan, who's here with us, who is our Chief Medical Officer and heading up our R&D efforts. But one, we had one of our first presentations is actual data at this year's ASN, he can talk to you more about that. And I think the restart dynamic, which I welcome Dr. Keenan's commentary on as well.

我將把其中的一部分交給 Greg Keenan 博士，他和我們在一起，他是我們的首席醫療官，負責領導我們的研發。但是，我們的第一個演示是今年 ASN 上的實際數據，他可以與您詳細討論這一點。我認為重啟動態，我也歡迎基南博士對此的評論。

I think we've learned that this restart phenomenon is kind of how the disease is treated. And today, not directed by guidelines, but actual physician practice, like they put a patient on drug, they get UPCR down to an acceptable level. And many times, a physician is then taking the patient off of the drug, not just our drug, any medication that they might be on. If UPCR flares, then they're putting them back on drug. And whether you look at EULAR or the KDIGO guidelines that were recently just updated, or we've got the appending or the impending ACR guidelines that we're hoping to get an eye on at this year's ACR meeting.

我想我們已經了解到這種重啟現象就是這種疾病的治療方式。如今，不再受指南指導，而是實際的醫生實踐，就像他們讓患者服用藥物一樣，他們將 UPCR 降至可接受的水平。很多時候，醫生會讓病人停止服用藥物，不僅是我們的藥物，還有他們可能正在服用的任何藥物。如果 UPCR 發作，那麼他們就會重新開始使用藥物。無論您是查看 EULAR 還是最近更新的 KDIGO 指南，還是我們希望在今年的 ACR 會議上關注的附加或即將發布的 ACR 指南。

I think the consistency of putting patients on drug, treating aggressively at early signs of UPC of elevated proteinuria in the urine, and keeping patients on drug for 3 to 5 years and not doing these treating flares is going to be absolutely consistent, at least our prediction. And we see that as a great opportunity as the market moves forward. That will, of course, affect restarts, but will also have a very positive impact on things like persistency. So, we think there's wind in our sales on both fronts at this stage. And why we see the importance of growing importance of hospital-based sales and restarts. Greg on the ENLIGHT-LN registry, what would you add there?

我認為，讓患者服藥、在尿蛋白尿升高的 UPC 早期症狀時積極治療、讓患者服藥 3 至 5 年而不進行這些治療發作的一致性將是絕對一致的，至少我們的預言。隨著市場的發展，我們認為這是一個巨大的機會。當然，這會影響重啟，但也會對持久性等方面產生非常正面的影響。因此，我們認為現階段我們在兩個方面的銷售都有所成長。以及為什麼我們看到基於醫院的銷售和重新啟動的重要性日益增加。Greg 在 ENLIGHT-LN 註冊表上，您會在那裡添加什麼？

Just we're starting to gain insight in the real world as to who's receiving this treatment. And importantly, a larger proportion than typically is observed in clinical trials we see of African-Americans that are receiving the treatment. Most recent data cut was over 35% of the participants are African-American or black. And then the other thing that we do observe is different combinations of treatments along with LUPKYNIS.

我們剛開始了解現實世界中誰正在接受這種治療。重要的是，我們在臨床試驗中觀察到接受治療的非裔美國人的比例比通常情況下要高。最近的數據顯示，超過 35% 的參與者是非裔美國人或黑人。我們觀察到的另一件事是 LUPKYNIS 治療的不同組合。

We're starting to see at least a little bit of combinations with BENLYSTA and just a few with Anifrolumab. So, we think over time, we'll gain more insight as to how people are using LUPKYNIS in the real world. For now, we're pleased with the number of patients we have and the success of the registry.

我們開始看到至少有一些與 BENLYSTA 的聯合用藥以及少數與 Anifrolumab 的聯合用藥。因此，我們認為隨著時間的推移，我們將更深入地了解人們如何在現實世界中使用 LUPKYNIS。目前，我們對我們擁有的患者數量和註冊的成功感到滿意。

Got it all helpful perspective. Thanks for taking our questions.

得到了所有有用的觀點。感謝您回答我們的問題。

Olivia Brayer, Cantor Fitzgerald.

奧利維亞·布雷耶，康托·菲茨杰拉德。

Hi, good morning. Thank you for the questions. And You guys have shown some really nice potency data for AUR200. So how are you thinking about the potential dose levels that you want to test in the clinic? I guess what I'm getting at is we've seen in this class that higher doses can have some safety or tolerability issues. But I'd also think that you guys could probably test lower doses with a higher potency drug. So just any comments on how you're thinking about doses and balancing efficacy with safety would be helpful. And then in terms of administration, it is a subcutaneous regimen. So, is it fair to assume that you're looking to develop an at-home administration product?

嗨，早安。謝謝你的提問。你們已經展示了 AUR200 的一些非常好的效能數據。那麼您如何考慮要在診所測試的潛在劑量等級？我想我的意思是我們在這堂課中看到較高劑量可能會產生一些安全性或耐受性問題。但我也認為你們可以用更有效率的藥物來測試更低的劑量。因此，任何有關您如何考慮劑量以及如何平衡功效與安全性的評論都會有所幫助。然後在給藥方面，是皮下注射的方案。那麼，假設您正在尋求開發家庭管理產品是否公平？

Olivia, I think the bottom line, and I'll take this question, core Greg, is we're in the single-ascending dose and multi-ascending dose studies now or we'll be moving into the multi-ascending dose trial. And these are the, they're all great questions. They're all things we're going to figure out in human beings in these studies. So, we look forward to reporting them to you as we get data.

奧利維亞，我認為最重要的是，我會回答這個問題，核心格雷格，我們現在正在進行單劑量遞增和多劑量遞增研究，或者我們將進入多劑量遞增試驗。這些都是很好的問題。這些都是我們在這些研究中要在人類身上找出的。因此，我們期待在獲得數據後向您報告。

Okay. Understood. Thanks dear.

好的。明白了。謝謝親愛的。

Will Soghikian, Leerink Partners.

威爾·索吉基安（Will Soghikian），Leerink Partners。

Great. Hey guys, thanks for taking our question here. We just have two quick ones. First, on LUPKYNIS, can you just provide a bit more color commentary on the environment in the third quarter? We can appreciate that sales remained pretty strong, but the regression in PSFs was a bit more acute than we've seen before just comparing to last year. And then on AUR200, there's been a lot of buzz in the anti-APRIL space with yet another asset entering the ring last week. So, can you just remind us how you're thinking about competitive differentiation and what indications you might be thinking about?

偉大的。嘿夥計們，感謝您在這裡提出我們的問題。我們只有兩個快速的。首先，關於LUPKYNIS，您能否對第三季的環境提供更多的色彩評論？我們可以看出，銷售仍然相當強勁，但與去年相比，PSF 的回歸比我們之前看到的要嚴重一些。然後，在 AUR200 上，上週又一個資產進入了反 APRIL 領域，引起了許多熱議。那麼，您能否提醒我們您如何考慮競爭差異化以及您可能正在考慮哪些跡象？

Yeah, I'll answer the last one first. Let us actually get the data from the SAD/MAD studies and see what they tell us before we come forward and tell you what indications we're trying to target, et cetera. We've got to get some human clinical data here. So I'm not trying to, in any way, dodge the question. I think we got to get smart once we see these trials and then move in the direction of the indications we want to go after. So more to come.

是的，我先回答最後一個。讓我們實際從 SAD/MAD 研究中獲取數據，看看它們告訴我們什麼，然後再告訴您我們正在嘗試針對哪些適應症等等。我們必須在這裡獲得一些人體臨床數據。所以我不想以任何方式迴避這個問題。我認為，一旦我們看到這些試驗，我們就必須變得聰明，然後朝著我們想要追求的跡象的方向前進。未來還會有更多。

On your first question, which centered on PSFs, as I said previously, yes, I mean, 3Q, we always have a summer dynamic. But I don't want to dig too much into that because I do think there was a little bit of that. More and more, we are seeing the combination of PSFs alongside of restarts and the hospital business as being the best way to look at our that coupled, of course, with what our patient retention looks like on a 12-month, 24-month, et cetera, basis is the best way to predict where revenue is going for the company. So gosh, our consistency, if you just kind of regress the business from launch to where it is today, is getting more and more predictive after 4 years of the drug being on the market and moving into our fifth year.

關於你的第一個問題，主要是 PSF，正如我之前所說，是的，我的意思是，第三季度，我們總是有夏季動力。但我不想對此深究太多，因為我確實認為有一點。我們越來越常看到，PSF 與重新啟動和醫院業務的結合是審視我們的最佳方式，當然，還有我們的病患保留率在 12 個月、24 個月、等等，基礎是預測公司收入去向的最佳方式。所以天哪，如果你把業務從上市到今天的情況回歸一下，我們的一致性在藥物上市四年並進入第五年之後變得越來越有預測性。

So not in any way trying to say that PSFs aren't important. They are, they're when new patients are starting drug according to our process, but understand patients start outside of our process too and that's restarts and, in the hospital, setting where they're not using our process. And if you look at those in combination, the robust, the growth quarter over quarter was robust. And as I said, Q4, when we report it, we'll actually be able to show you like numbers on Q4 last year for PSFs, Q4 for hospital starts in Q4 for new patient restarts. And those in combination are where we're moving to really start looking at, in aggregate, the new patients getting on drug within the quarter.

因此，絕不是試圖說 PSF 不重要。是的，當新患者根據我們的流程開始用藥時，但了解患者也在我們的流程之外開始用藥，這就是重新開始，在醫院裡，設置他們不使用我們的流程的地方。如果你把這些綜合起來看，你會發現季度與季度之間的強勁成長是強勁的。正如我所說，第四季度，當我們報告時，我們實際上能夠向您展示去年第四季度 PSF 的數字，第四季度醫院開始的新患者重啟的數字。這些綜合起來就是我們真正開始關注本季內接受藥物治療的新患者的整體情況。

Great. Thank you for that commentary.

偉大的。謝謝你的評論。

There are no further questions at this time. So, I would like to hand back to Peter Greenleaf, CEO, for closing remarks.

目前沒有其他問題。因此，我想請執行長 Peter Greenleaf 致閉幕詞。

Thank you, operator, and thank you, everyone, for joining the call today. We look forward to continuing to report our progress as we continue to move the business forward and build the business for the long term. Thank you very much for your time.

謝謝接線員，也謝謝大家今天加入通話。我們期待繼續報告我們的進展，繼續推動業務發展並建立長期業務。非常感謝您抽出時間。

That does conclude our conference for today. Thank you for participating. You may now all disconnect.

我們今天的會議到此結束。感謝您的參與。你們現在可以斷開連結了。