Aurinia Pharmaceuticals Inc (AUPH) 2025 Q1 法說會逐字稿

Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Q1 2025 earnings call. (Operator Instructions) As a reminder, this conference is being recorded. It's not my pleasure to turn the call over to Andrea Christopher, corporate communications and Investor relations. Please go ahead, Andrea.

您好，歡迎參加 Aurinia Pharmaceuticals Inc. 2025 年第一季財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。我不樂意將電話轉給企業傳播和投資者關係部門的安德里亞·克里斯托弗 (Andrea Christopher)。請繼續，安德里亞。

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, Aurinia's Chief Financial Officer; and Dr. Greg Keenan, Aurinia's Chief Medical Officer.

謝謝接線員，也謝謝大家參加今天的電話會議和網路直播。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、Aurinia 財務長 Joe Miller；以及 Aurinia 首席醫療官 Greg Keenan 博士。

Today we will review and discuss Aurinia's first quarter, 2025 financial results, and provide an update on recent corporate progress as communicated in the company's press release and quarterly report on Form 10-Q issued 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.

今天，我們將回顧和討論 Aurinia 2025 年第一季的財務業績，並提供公司新聞稿和今天上午發布的 10-Q 表季度報告中所述的近期公司進展。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管理局提交的文件，這些文件也可在 Aurinia 的網站 auriniapharma.com 上查閱。

During today's call, Aurinia's 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 可能會根據當前預期做出前瞻性陳述。這些前瞻性的陳述。受許多重大風險和不確定性的影響，實際結果可能存在重大差異。

For a discussion of factors that could affect Aurinia's future financial results in business, please refer to the disclosures in Aurinia's press release, quarterly report on Form 10-Q and all other filings with the US Securities and Exchange Commission and Canadian Securities authorities.

有關可能影響 Aurinia 未來業務財務表現的因素的討論，請參閱 Aurinia 的新聞稿、10-Q 表季度報告以及向美國證券交易委員會和加拿大證券當局提交的所有其他文件中披露的內容。

Please note that all statements made during today's call are current as of today, May 12, 2025, 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 statement. 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，今天電話會議中所作的所有聲明均為截至 2025 年 5 月 12 日的最新聲明，並且基於我們目前掌握的信息，除非法律要求，否則 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 today. On this morning's call, I'll provide an update on our first quarter of 2025 results and provide an update on recent progress. 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。我要感謝大家今天的出席。在今天早上的電話會議上，我將介紹我們 2025 年第一季的業績更新以及最近的進展。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 a continued focus on commercial execution and driving operational efficiency, we achieved strong growth in total revenue and net product sales in the first quarter.

透過持續專注於商業執行和提高營運效率，我們在第一季實現了總收入和淨產品銷售額的強勁成長。

For the first quarter of 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. For the first quarter of 2025, net product sales of LUPKYNIS, the first FDA approved oral therapy for the treatment of adult patients with active lupus nephritis, or ALN, were $60 million, up 25% from $48.1 million in the same period of 2024.

2025 年第一季總營收為 6,250 萬美元，較 2024 年同期的 5,030 萬美元成長 24%。2025 年第一季度，FDA 批准的首個用於治療活動性狼瘡性腎炎（ALN）成人患者的口服療法 LUPKYNIS 的淨產品銷售額為 6000 萬美元，較 2024 年同期的 4810 萬美元增長 25%。

The increase is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies and driven by further lupus nephritis penetration.

成長的主要原因是銷售給專科藥局的 LUPKYNIS 紙盒數量增加，以及狼瘡性腎炎藥物進一步滲透。

The three months ended March 31, 2025., cash flow generated from operations was $1.3 million, compared to a negative $18.6 million in cash flow used in operations in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.

截至 2025 年 3 月 31 日的三個月，營運產生的現金流為 130 萬美元，而 2024 年同期營運使用的現金流為負 1,860 萬美元。不包括與 2024 年 11 月重組相關的 1,110 萬美元現金支付，截至 2025 年 3 月 31 日的三個月，經營活動產生的現金流量為 1,240 萬美元。

Exiting the quarter, we have cash, cash equivalents, restricted cash, and investments of $312.9 million, as compared to $358.5 million in December 30, 2024. For the three months ended March 31, 2025, the company repurchased 5.8 million of its common shares for $47.4 million.

截至本季末，我們的現金、現金等價物、受限現金和投資為 3.129 億美元，而 2024 年 12 月 30 日為 3.585 億美元。截至 2025 年 3 月 31 日的三個月，該公司以 4,740 萬美元回購了 580 萬股普通股。

With our solid 25% increase in sales growth for LUPKYNIS in the first quarter, we are poised for continued success in 2025. Following the recent update of the American College of Rheumatology lupus nephritis treatment guidelines, which recommends the incorporation of drugs like LUPKYNIS into first line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm.

隨著 LUPKYNIS 第一季銷售額穩定成長 25%，我們有望在 2025 年繼續取得成功。根據美國風濕病學會最近更新的狼瘡性腎炎治療指南，建議將 LUPKYNIS 等藥物納入一線治療，我們的商業組織致力於教育風濕病學家了解在治療模式早期開始使用 LUPKYNIS 的益處。

We have started the year in a solid position with a highly efficient organization focused on LUPKYNIS growth, and are therefore reiterating our total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million for 2025.

我們以穩固的地位開啟了新的一年，高效的組織專注於 LUPKYNIS 的成長，因此我們重申 2025 年總收入預期在 2.5 億美元至 2.6 億美元之間，淨產品銷售額預期在 2.4 億美元至 2.5 億美元之間。

Finally, we remain on track to report initial results from the Phase 1 study of our pipeline product, AUR200, a dual BAFF/APRIL inhibitor for the potential treatment of a range of autoimmune diseases later this quarter.

最後，我們將按計劃於本季稍後報告我們的管道產品 AUR200（一種雙重 BAFF/APRIL 抑制劑，可用於治療一系列自體免疫疾病）的第一階段研究的初步結果。

I'd like to now turn the call over to Joe Miller, our CFO, for a more detailed review of our first quarter 2025 financial results. I'll then return at the end of the call for a quick recap and to open up the line to any questions you might have. Joe?

現在，我想將電話轉給我們的財務長喬·米勒 (Joe Miller)，以便更詳細地審查我們 2025 年第一季的財務業績。通話結束後，我會回來快速回顧一下，並回答大家可能提出的任何問題。喬？

Thank you, Peter, and good morning, everyone. Let's take a few minutes to discuss the first quarter, 2025 financial results. For the three months ended March 31, 2025, total revenue was $62.5 million, compared to $50.3 million in the same period of 2024.

謝謝你，彼得，大家早安。讓我們花幾分鐘討論一下 2025 年第一季的財務表現。截至 2025 年 3 月 31 日的三個月，總收入為 6,250 萬美元，而 2024 年同期為 5,030 萬美元。

As Peter mentioned, we had cash, cash equivalents, restricted cash, and investments of $312.9 million as of March 31, 2025, and generated cash flows from operations of $1.3 million. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.

正如彼得所提到的，截至 2025 年 3 月 31 日，我們的現金、現金等價物、受限現金和投資為 3.129 億美元，經營活動產生的現金流為 130 萬美元。不包括與 2024 年 11 月重組相關的 1,110 萬美元現金支付，截至 2025 年 3 月 31 日的三個月，經營活動產生的現金流量為 1,240 萬美元。

We are continuing to be opportunistic with our share repurchase program and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand.

我們將繼續把握機會實施股票回購計劃，並期望利用經營活動產生的現金流量和現有現金為未來任何可自由支配的股票回購提供資金。

The company repurchased 14.5 million of its common shares for $108.5 million since the launch of the program in the first quarter of 2024 through May 8, 2025.

自 2024 年第一季啟動該計畫以來至 2025 年 5 月 8 日，該公司以 1.085 億美元回購了 1,450 萬股普通股。

For the three months ended March 31, 2025, cost of revenue was $8.6 million, compared to $7.8 million in the same period of 2024. The increase is primarily due to an increase in Aurinia's net sales of LUPKYNIS. For the three months ended March 31, 2025, gross margin was 86% compared to 85% in the same period of 2024.

截至 2025 年 3 月 31 日的三個月，收入成本為 860 萬美元，而 2024 年同期為 780 萬美元。成長的主要原因是 Aurinia 的 LUPKYNIS 淨銷售額增加。截至 2025 年 3 月 31 日的三個月，毛利率為 86%，而 2024 年同期為 85%。

For the three months ended March 31, 2025, total operating expenses were $40.6 million, compared to $63.6 million in the same period of 2024. The decrease is primarily due to lower personnel expenses, including share-based compensation and overhead costs, as a result of our strategic restructuring efforts in 2024, coupled with a reduction in non-personnel R&D expenses as a result of ceasing development of the company's AUR300 development program and restructuring related one-time charges in the first quarter of 2024 that did not recur in 2025.

截至 2025 年 3 月 31 日的三個月，總營運費用為 4,060 萬美元，而 2024 年同期為 6,360 萬美元。減少的主要原因是，由於我們在 2024 年進行了策略重組，人員費用（包括股權激勵和間接費用）減少，再加上由於公司停止開發 AUR300 開發計劃和重組 2024 年第一季度的相關一次性費用（這些費用在 2025 年不再發生），非人員研發費用減少。

This was partially offset by an increase in R&D related expenses as we continue to advance our AUR200 program and other non-cash expenses related to the remeasurement of our Swiss Franc denominated monoplant finance lease liability and changes in our fair value assumptions related to our deferred compensation liability.

由於我們繼續推進 AUR200 計劃，研發相關費用增加，以及與重新計量以瑞士法郎計價的單一工廠融資租賃負債和與遞延薪酬負債相關的公允價值假設變化相關的其他非現金費用，部分抵消了這一增長。

For the three months ended March 31, 2025, net income was $23.3 million or $0.17 of earnings per share compared to a net loss of $10.7 million or $0.07 of net loss per share in the same period of 2024. With that, I'd like to hand the call back over to Peter for some closer remarks. Peter?

截至 2025 年 3 月 31 日的三個月，淨收入為 2,330 萬美元，即每股收益 0.17 美元，而 2024 年同期的淨虧損為 1,070 萬美元，即每股淨虧損 0.07 美元。說完這些，我想把電話交還給彼得，讓他進一步發言。彼得？

Thanks, Joe. In summary, we're continuing to lean into our highest growth drivers to the commercial LUPKYNIS business, continuing clinical development of AUR200, and maintaining excellent operational efficiency throughout the organization. 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。總之，我們將繼續把最高的成長動力集中在商業 LUPKYNIS 業務上，繼續進行 AUR200 的臨床開發，並在整個組織內保持卓越的營運效率。我想感謝大家今天抽出時間。我們現在將開放式熱線來回答您可能提出的任何問題。操作員？

(Operator Instructions)

（操作員指示）

Stacy Ku, TD Cowen.

史黛西·庫（Stacy Ku），考恩公司（Cowen）TD。

Hey, good morning. Congrats on the solid quarter and thanks for taking our questions. First question is on LUPKYNIS, can you maybe just talk about the quarterly cadence as we think about Q1 sales and your guidance for the year?

嘿，早安。恭喜本季業績穩健，感謝您回答我們的問題。第一個問題是關於 LUPKYNIS 的，您能否談談季度節奏，我們考慮一下第一季度的銷售額以及您對今年的指導？

Understand you're not disclosing metrics, but if you're not willing to comment on the quarterly cadence, maybe talk about what's driving sales these days. Is it largely new patient ads or is it more of the additional restarts and hospital ads? That's the first question.

請理解您不會透露指標，但如果您不願意對季度節奏發表評論，也許可以談談目前推動銷售的因素。主要是新病人的廣告還是更多的是額外的重啟和醫院的廣告？這是第一個問題。

And then the second question is on AUR200. Just as we near the phase one single sending those update, maybe talk about some base case scenarios on how you give an update on next steps. Just maybe curious if you could speak to some strategies to get to market faster, what type of regulatory pathway you think is feasible as we think about other anti-APRIL/BAFF agents. Thanks so much.

第二個問題是關於 AUR200 的。就在我們接近第一階段發送這些更新的時候，也許可以討論如何更新後續步驟的一些基本情況。我只是好奇您是否可以談談一些更快進入市場的策略，當我們考慮其他抗 APRIL/BAFF 藥物時，您認為哪種監管途徑是可行的。非常感謝。

Thanks, Stacy. Let me start with the first one. On LUPKYNIS, obviously we're guiding to a range of 240 to 250. I think the best way to think about the quarterly gate is to go back and look at historical, and I think that will help in terms of how this business has performed consistently quarter on quarter and.

謝謝，史黛西。讓我先從第一個開始。在 LUPKYNIS 上，顯然我們指導的範圍是 240 到 250。我認為思考季度關口的最佳方式是回顧歷史，我認為這將有助於了解該業務的季度間表現如何。

Obviously somewhere in the 2Q, 3Q range, we've historically seen some effect in the summer and then we've historically seen kind of a lift and rise into the back half of the year and that's been pretty predictive for the last several years.

顯然，在第二季或第三季的某個時候，我們歷史上看到夏季的一些影響，然後我們歷史上看到下半年的某種提升和上升，這在過去幾年中是相當預測的。

In terms of mix and drivers, what I can tell you is the full complement is still driving the business, everything from new patient ads to persistency, time to getting patients on drugs. All of those continue to show improvement for us, but that improvement I would look at holistically. It's not any one key driver.

就組合和驅動因素而言，我可以告訴你的是，全方位的補充仍在推動業務發展，從新患者廣告到持久性、從時間到讓患者服藥的一切。所有這些都表明我們的進步正在繼續，但我會從整體上看待這種進步。這不是任何一個關鍵驅動因素。

I will tell you lastly that our goal is to continue to drive rheumatology, and we've actually seen some good improvements in terms of rheumatology prescribing. Not that we're overly trying to favor one versus the other, but we think it's indicative of early diagnosis and early treatment when rheumatologists are taking the lead in treating these patients.

最後我要告訴你們，我們的目標是繼續推動風濕病學的發展，而且我們實際上已經看到風濕病學處方方面取得了一些很好的進展。我們並不是過度偏袒某一方，但我們認為，當風濕病學家帶頭治療這些患者時，這表明早期診斷和早期治療。

So a good quarter, I think our guidance range staying consistent gives you where we think we're going to fall out and I think that's about it. On the AUR200, not to give you nothing here, but we're between now and the end of June, we intend to report out the data and I would just ask you to wait till then and that'll be our single ascending dose data and we'll give more steer on the program once we get there.

因此，我認為，一個好的季度，我們的指導範圍保持一致，可以告訴你我們認為我們將會跌落到什麼程度，我想就是這樣。關於 AUR200，這裡不提供任何信息，但是從現在到 6 月底，我們打算報告數據，我只是要求您等到那時，那將是我們的單次上升劑量數據，一旦我們到達那裡，我們將對該計劃提供更多指導。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特（Maury Raycroft），傑富瑞集團（Jefferies）。

Hi, good morning. Congrats on the quarter and thanks for taking my questions. I'll ask one just on guidance to you. So for historically 1st quarter tends to be the lowest quarter. So just wondering if you're expecting 2nd quarter to be in line or lower and what are you seeing in the initial six weeks and second quarter that informs the rest of your year outlook for the rest of the year?

嗨，早安。恭喜本季取得佳績，感謝您回答我的問題。我會問一個只是為了指導你。因此從歷史上看，第一季往往是最低的季度。所以我只是想知道您是否預計第二季的銷售額會持平或下降，以及您對前六週和第二季的觀察對今年剩餘時間的展望有何影響？

Yeah, I'm not sure. I'd have to go back. I don't think 1Q is usually our lowest quarter. I think somewhere between the 2Q, 3Q spread because it incorporates the summer usually using history has been the lower and then usually historically we've come back to a rise in 4Q.

是的，我不確定。我必須回去。我認為第一季通常不是我們業績最低的季度。我認為介於第二季和第三季之間的某個時間點，因為它包含了夏季，通常使用歷史數據會比較低，然後通常從歷史上看，我們會在第四季度回升。

So in terms of our guidance range, I think we are using history probably more than anything to sort of where we're going for the year and that would include what we've seen historically as a soft summer. We're only sort of one cu through this into 2Q, so we've got some time ahead of us and look forward to reporting 2Q when we do that. In terms of drivers, I kind of already talked to that May, but I think if you look at last year and the year before, probably that's the best way to think about quartering the remainder of the year.

因此，就我們的指導範圍而言，我認為我們可能更多地參考歷史來判斷今年的發展方向，其中包括我們歷史上看到的疲軟夏季。我們只經歷了一個季度，進入了第二季度，所以我們還有一些時間，並期待屆時報告第二季度業績。就驅動因素而言，我可能已經在 5 月談論過這個問題，但我認為，如果你回顧去年和前年，這可能是思考今年剩餘時間季度表現的最佳方式。

Got it. And just wanted to ask on the ANDA filers too. It seems like there's a good number of those challenging the validity of the 2037 dosing protocol patent. Wondering if you just talk more about that and what the strategy and risks are there?

知道了。只是想問 ANDA 申請人的情況。似乎有相當多的人對 2037 年劑量方案專利的有效性提出質疑。想知道您是否能進一步談談這一點以及其中的策略和風險是什麼？

Well, I mean, I think we've commented on this historically, so there's really nothing new outside of the fact that we've had filers initially come in with ANDAs.

嗯，我的意思是，我認為我們在歷史上已經對此發表過評論，所以除了我們有最初帶著 ANDA 進來的申請人這一事實之外，實際上沒有什麼新鮮事。

We've obviously filed patent infringement lawsuits against all of them, intend to vigorously defend the patents that we have and we'll keep you updated along the way, but obviously you know that that through that it automatically puts these filers under a 30 month stay of execution. And we'll have to just see that process through and we have continued work that we're doing in the organization to.

我們顯然已經對所有這些人提起了專利侵權訴訟，打算大力捍衛我們擁有的專利，我們會隨時向您通報最新進展，但顯然您知道，這樣做會自動使這些申請人處於 30 個月的暫緩執行期。我們必須完成這個過程，並繼續在組織內開展工作。

I guess I would just leave it with the longevity of kindness is an a priority for the organization, so it's all hands on deck and not just defending our patents, but making sure that we're working hard towards keeping that revenue stream coming in and the drug being an important drug for us well into the future.

我想我只想說，善良的長久是該組織的首要任務，所以所有人都在努力，不僅要捍衛我們的專利，還要確保我們努力保持收入來源，並確保這種藥物在未來很長一段時間內都是我們的重要藥物。

Joseph Schwartz, Leerink Partners.

Leerink Partners 的 Joseph Schwartz。

Great. So I just had a couple of questions on potential new federal government policies here and Aurinia's potential exposure to tariffs in MFN. So could you, first of all, just help us understand where the IP is domiciled for LUPKYNIS?

偉大的。因此，我只想問幾個關於聯邦政府可能出台的新政策以及 Aurinia 在最惠國關稅方面可能面臨的風險的問題。那麼，首先，您能否幫助我們了解 LUPKYNIS 的智慧財產權位於哪裡？

How you're importing any product from overseas, whether it's at COGS or transfer prices if you've got significant drug stockpiled in the US? And if you can grow supply within the US over time? And then how should we think about any exposure Aurinia has to potential MFN legislation based on the amount of government reimbursement for LUPKYNIS?

如果您在美國儲存了大量藥品，您如何從海外進口任何產品，是按銷貨成本還是轉移價格？那麼隨著時間的推移，您是否可以增加美國境內的供應？那麼，根據政府對 LUPKYNIS 的補償金額，我們應該如何看待 Aurinia 可能受到的最惠國立法的影響？

Yeah, there's a lot there, Joe. So let me just start with the tariff side of the equation, I guess. As you know, our API is done in Switzerland. But to be clear, we have several years’ worth of product that sits on US soil. And I think that even if tariffs were depending on what the range of tariffs could be, it's on a very small percentage of our overall cost of goods at the API level.

是的，那裡有很多，喬。因此，我想先從關稅問題開始。如您所知，我們的 API 是在瑞士完成的。但要先明確的是，我們在美國本土儲存了可供使用數年的產品。我認為，即使關稅取決於關稅範圍，它也只佔 API 等級商品總成本的一小部分。

We do all our fill, finish work or our packaging work here in the US. So we think minimal to no impact over, say, next several years and then TBD as to what those tariffs would look like and what the impact would be on our API. Of course, like most, we're working hard to ensure we have as much product in the US. as possible. And as I said, we've got several years here.

我們所有的填充、完成工作或包裝工作都在美國進行。因此，我們認為，在未來幾年內，影響將很小甚至沒有影響，然後還需確定這些關稅的具體情況以及對我們的 API 的影響。當然，和大多數人一樣，我們正在努力確保我們在美國擁有盡可能多的產品。盡可能。正如我所說，我們已經在這裡待了好幾年了。

In terms of transfer pricing, et cetera, we're watching this like everybody else. Obviously, we're a Canadian company that does business in the US. So transfer pricing is part of how our economic model works. My understanding is that we've taken not an executive quarter, but an act of Congress to actually go and impact that.

在轉讓定價等方面，我們也和其他人一樣關注著這個問題。顯然，我們是一家在美國開展業務的加拿大公司。因此，轉移定價是我們的經濟模式運作的一部分。我的理解是，我們採取的不是行政措施，而是國會的法案，來真正影響這一點。

So our ears are open and we're kind of watching where the market goes on this and where the President, his administration goes as it relates to not tariffs, but the element of transfer pricing for ex US companies operating within the US.

因此，我們隨時關注市場對此的走向，以及總統及其政府的行動，因為這不僅與關稅有關，還與在美國境內運營的美國外公司的轉讓定價因素有關。

And then lastly, the most recent executive order, your guess is as good as mine. It kind of seems like there is a directive put out there under an executive order by President Trump and then where it eventually lands if it lands is kind of a TBD. So we're watching that as closely as you are. Because, obviously, the entire pharmaceutical and really health care industry is affected by the government pricing side of the business.

最後，關於最近的行政命令，你的猜測和我的一樣好。這看起來就像是川普總統根據行政命令發布的一項指令，但該指令最終會在何處實施仍有待確定。因此，我們和您一樣密切關注此事。因為，顯然，整個製藥和醫療保健產業都受到政府定價的影響。

To recall, our business is pretty evenly split between commercial pay, public pay -- or excuse me, private pay and the government side of the business. So obviously, it's something we're watching closely.

回想一下，我們的業務在商業支付、公共支付（或不好意思，是私人支付）和政府業務之間分配得相當均勻。顯然，這是我們正在密切關注的事情。

Olivia Brayer, Cantor Fitzgerald.

奧莉維亞·布雷爾，費茲傑拉領唱者。

So for AUR200, is there anything you can say just around how many patients will see data from or how many dose levels you've studied in that SAD trial. And maybe just overall thoughts around what kind of dosing schedule you think you'll need to be competitive and whether at home administration is important or not?

那麼對於 AUR200，您能否透露一下有多少患者將看到數據，或者您在該 SAD 試驗中研究了多少個劑量水平。也許只是整體考慮一下您認為需要什麼樣的給藥時間表才能具有競爭力，以及在家中管理是否重要？

Yeah. I think those are all good questions, and we look forward to. It's now almost mid-May. And as we've said between now and the end of June, we're going to report out that set of data. So we look forward to showing you what we've got.

是的。我認為這些都是很好的問題，我們期待。現在快到五月中旬了。正如我們所說的，從現在到六月底，我們將會報告這組數據。因此，我們期待向您展示我們所擁有的一切。

Obviously, in the areas of proteinuria kidney diseases and the like, there is more than one APRIL/BAFF ahead of us in the IgAN space. So we'll learn what we've got as it relates to others in just a short couple of weeks.

顯然，在蛋白尿腎病變等領域，在 IgAN 領域，有不只一個 APRIL/BAFF 領先於我們。因此，我們將在短短幾週內了解我們所獲得的資訊與其他資訊的關聯。

Okay. Peter, anything you can say just around data disclosure in terms of how you guys are -- where you hope to call and kind of what level of details just in terms of next steps, should we expect to see then?

好的。彼得，關於數據揭露，你能說說你們的情況嗎？您希望聯繫誰，以及下一步我們應該看到哪些程度的細節？

Yes. I mean, outside of the fact that we've committed to reporting out that single ascending dose data by the end of June. No, we're not giving any guide as to how much data and what will show in addition to that. So more to come. We got to discuss it -- we got to see what the data is first because obviously, this trial is ongoing.

是的。我的意思是，除了我們承諾在 6 月底之前報告單次劑量上升數據之外。不，我們沒有提供任何關於除此之外將顯示多少數據以及顯示什麼內容的指南。未來還會有更多。我們必須討論它——我們必須先看看數據是什麼，因為顯然這個試驗仍在進行中。

And then we have to sit with our board and talk about what we want to disclose publicly as it relates to not just a program, but where we intend to go from there. So we look forward to doing that, but it's between now and the end of June.

然後，我們必須與董事會坐在一起討論我們想要公開披露的內容，因為這不僅與計劃有關，還與我們打算從那裡走向何方有關。因此，我們期待著做到這一點，但時間是從現在到六月底。

Sahil Dhingra, RBC Capital Markets.

加拿大皇家銀行資本市場的 Sahil Dhingra。

This is Sahil for [Doug Miehm]. I have two. My first question is related to the SG&A expense. So that was around $20 million this quarter, and it was a bit below what we were -- we had modeled. So I want to know if there was any one-time item in it. And how should we think about the SG&A expense going forward?

這是 Sahil[道格·米姆]。我有兩個。我的第一個問題與銷售、一般及行政費用有關。所以本季的金額約為 2000 萬美元，略低於我們預測的金額。所以我想知道裡面是否有任何一次性物品。我們該如何看待未來的銷售、一般及行政費用？

All right. So the question was on SG&A. We don't give expense level guide, but maybe Joe can give a little bit on the quarter and how to think about it as it relates to the year.

好的。所以問題是關於銷售、一般和行政費用 (SG&A)。我們沒有提供費用水平指南，但也許喬可以提供一些關於本季度的信息以及如何將其與年度聯繫起來。

Thank you for the question, Sahil. Yeah, we don't provide specific guidance on OpEx by function. What I will say is that following our restructuring in November, we are on track to achieve our previously announced cash-based OpEx savings of approximately $40 million. So again, the cash flows reported today is a result of our strong sales performance and represents the early benefit of streamlining our operations.

謝謝你的提問，薩希爾。是的，我們沒有提供按功能劃分的營運支出的具體指導。我想說的是，經過 11 月的重組，我們預計將實現先前宣布的約 4,000 萬美元的現金營運支出節約。因此，今天報告的現金流是我們強勁銷售業績的結果，代表了我們精簡營運的早期效益。

So as you look to kind of our SG&A expense, there was a small true-up as it related to stock-based compensation that ran through there. You can see that in the footnotes as it relates to our equity-based footnote. But outside of that, there was nothing unusual embedded within that functional line.

因此，當您查看我們的銷售、一般和行政費用時，會發現有一個小的調整，因為它與貫穿其中的股票薪酬有關。您可以在腳註中看到它與我們基於股權的腳註相關。但除此之外，該功能線內並沒有什麼不尋常的東西。

Okay. Then my second question is on Roche's guide that is expected where the PDUFA date is in October 2025. So how do you expect the evolution of the LN treatment market and what impact do you think will it have on LUPKYNIS adoption?

好的。我的第二個問題是關於羅氏的指南，預計 PDUFA 日期是 2025 年 10 月。那麼您如何預期 LN 治療市場的發展以及您認為它會對 LUPKYNIS 的採用產生什麼影響？

Why don't I start and I have a rheumatologist here in the room with me. So it would be good to get his perspective as well, that's Dr. Keenan, Chief Medical Officer. So Listen, I'm excited to have more large pharmaceutical companies into the lupus nephritis and the lupus market to help us grow awareness. Obviously, these guidelines that are most recently issued by the ACR, ULR, and KDIGO, all call for much more aggressive diagnosis and early treatment of the disease.

我先開始吧，房間裡還有一位風濕病專家。因此，了解他的觀點也很好，他是首席醫療官基南博士。所以聽著，我很高興有更多的大型製藥公司進入狼瘡性腎炎和狼瘡市場，幫助我們提高意識。顯然，ACR、ULR 和 KDIGO 最近發布的這些指南都呼籲對該疾病進行更積極的診斷和早期治療。

If that actually happens, we've got internal data to show that the market will grow. And the more companies we have educating on those guidelines will help us we believe, to expand the market. So that's number one.

如果這種情況真的發生，我們有內部數據顯示市場將會成長。我們相信，對更多公司進行這些指導方針的教育將有助於我們擴大市場。這是第一點。

Number two, obviously, Gazyva has got some data. And we've seen it and obviously, we filed -- I think we feel pretty confident that their filing will most likely be reviewed and they have a high probability of getting approval.

第二，顯然，Gazyva 已經獲得了一些數據。我們已經看到了，顯然，我們已經提交了申請——我認為我們非常有信心，他們的申請很可能會被審查，而且獲得批准的可能性很高。

Not that we can predict that, not that we're the owners of the asset in those conversations with the agency, but we think it's likely. It is a B-cell pathway drug. Greg, do you want to give any comment on what we see in the data as it relates to the drug and how the guidelines are?

我們無法預測這一點，在與該機構的對話中我們也不是資產的所有者，但我們認為這是可能的。它是一種B細胞通路藥物。格雷格，您想對我們在數據中看到的與藥物相關的內容以及指南內容發表任何評論嗎？

Thank you, Peter. So First off, it's a great news for individuals and clinicians that care for people with lupus nephritis. The data there is encouraging and certainly supplementing what Peter was saying. We believe that this B-cell agent will have an important role. The guidelines that were just issued last year, find a place for Ben listing. You can imagine the opportunity for Labetuzumab to fit in that Category 2 of B-cell agents.

謝謝你，彼得。首先，這對於照顧狼瘡性腎炎患者的個人和臨床醫生來說是一個好消息。那裡的數據令人鼓舞，並且肯定補充了彼得所說的話。我們相信這種B細胞藥物將發揮重要作用。去年剛推出的指導方針，為本上市找個地方。您可以想像 Labetuzumab 躋身 B 細胞治療藥物第 2 類的機會。

We think nonetheless, that LUPKYNIS with its strong evidence and the timeliness of benefit achieving goals therapeutic goals, some within one month and six months’ time that it will have a role in helping patients and doctors meet their old quickly, which is a key part of what the ACR guidelines emphasize.

儘管如此，我們認為，LUPKYNIS 憑藉其強有力的證據和在一個月或六個月內實現治療目標的及時性，將在幫助患者和醫生快速實現治療目標方面發揮作用，這也是 ACR 指南強調的關鍵部分。

I'll point out that the ACR guidelines in print have just been released this month, and it's very specific and the role for CNIs like voclosporin is explicit, not just in Class 3 and 4, but also in 5. And so we think that it's a good day for patients. LUPKYNIS is going to continue to have an important role in helping patients achieve their goals.

我要指出的是，印刷版的 ACR 指南本月剛發布，它非常具體，並且像 voclosporin 這樣的 CNI 的作用很明確，不僅在 3 類和 4 類中，而且在 5 類中也是如此。因此我們認為這對患者來說是美好的一天。LUPKYNIS 將繼續發揮重要作用，幫助患者實現他們的目標。

Yeah, I think it comes to me comes down to speed. And while these products are obviously getting approved. If it takes two years to get the effect that we get at one year and quite frankly, that we see it at three months and six months, the guidelines are calling for rapid reductions of proteinuria and these B-cell agents so far have not been able to achieve the rapidity of response and reduction in proteinuria that the guidelines are calling for. So in other words, we think we have a very competitive profile.

是的，我認為對我來說這取決於速度。雖然這些產品顯然已經獲得批准。如果需要兩年時間才能達到一年的效果，坦白說，需要三個月和六個月才能看到效果，那麼指南要求快速減少蛋白尿，而這些 B 細胞藥物迄今為止還不能達到指南所要求的快速反應和減少蛋白尿的效果。換句話說，我們認為我們具有非常強的競爭力。

David Martin, Bloom Burton.

大衛馬丁、布魯姆伯頓。

My understanding is that LUPKYNIS is quite difficult to manufacture. The fact that you now have ANDA filers, does that infer to you that they've solved the puzzle and should they be able to manufacture the drug matching LUPKYNIS at commercial scale?

我的理解是，LUPKYNIS 製造起來相當困難。事實上，你們現在有了 ANDA 申請人，這是否意味著他們已經解決了這個難題，並且他們是否能夠以商業規模生產與 LUPKYNIS 相匹配的藥物？

We don't have any insight into that outside of -- as part of their ANDA package, you'll have to show that they can actually manufacture. So we haven't changed our position on what we believe our process is whether they can duplicate it or find a way to do it differently is TBD. We haven't seen our actual file of package.

我們對此沒有任何了解——作為其 ANDA 包的一部分，您必須證明他們確實可以生產。因此，我們並沒有改變我們的立場，我們相信我們的流程是他們是否可以複製它或找到不同的方法還有待確定。我們還沒有看到我們的實際包裹文件。

Okay. And next major events in the patent litigation, what kind of timing should we expect and what events are coming up?

好的。那麼專利訴訟中的下一個重大事件，我們應該期待什麼樣的時機以及即將發生哪些事件？

I mean we've obviously have filed patent infringement lawsuits. I don't think we intend to disclose major milestones in the IP patent defense space will report them when there are major things to update on. But now we are in the throes of litigation, and I think you can look at any analog product, small molecule product that is in the end a battle and use that as a way to predict what we're going to see going forward, but we don't intend to give timelines on legal proceedings.

我的意思是我們顯然已經提起了專利侵權訴訟。我認為我們無意揭露智慧財產權專利防禦領域的主要里程碑，只有在有重大事項需要更新時才會報告。但現在我們正處於訴訟的陣痛之中，我認為你可以看看任何類似物產品、小分子產品最終都會是一場戰鬥，並以此來預測我們未來會看到什麼，但我們不打算給出法律訴訟的時間表。

Okay. And then one last question. What endpoints do you anticipate could differentiate AUR200 from other APRIL and BAFF inhibitors with the Phase 1 SAD results?

好的。最後一個問題。您預計哪些終點可以透過第 1 階段 SAD 結果將 AUR200 與其他 APRIL 和 BAFF 抑制劑區分開來？

I think the Phase 1 SAD results are obviously going to give us the pharmacokinetics and the pharmacodynamics of the product. That's everything from half-life of the product, which could be directly juxtaposed against what the dose of the product could be, how often you have to give it.

我認為第一階段的 SAD 結果顯然會為我們提供該產品的藥物動力學和藥效學。這就是產品的半衰期，它可以直接與產品的劑量以及給藥頻率進行比較。

We're going to get hopefully a good idea, the range of doses and then the impact on biomarkers like IgG, IgA, IgM, and all those things will give us and give the market a way to assess how the product looks versus others in the space. And alongside of a strategic development pathway from there, those will all be important to look at as we roll out this single ascending dose data.

我們希望得到一個好主意，劑量範圍以及對 IgG、IgA、IgM 等生物標誌物的影響，所有這些都將為我們和市場提供一種方法來評估該產品與該領域其他產品相比的外觀。除了從那裡開始的策略發展路徑之外，當我們推出這項單次上升劑量數據時，這些都是值得關注的重要因素。

Thank you. We reached end of our question-and-answer session. And I's like to turn the floor back over for any further closing comments.

謝謝。我們的問答環節結束了。我想再次請大家發表進一步的結論。

Well, I want to thank everybody for taking the time with us today. Happy belated Mother's Day, and we look forward to updating as the quarters roll forward here. Thank you.

好吧，我想感謝大家今天抽出時間與我們在一起。祝您母親節快樂（雖然有點晚了），我們期待在接下來的季度中不斷更新。謝謝。

Thank you. That does conclude today's teleconference and webcast. You may just connect your line at this time and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網路直播到此結束。此時您便可以接通電話並度過美好的一天。我們感謝您今天的參與。