Aurinia Pharmaceuticals Inc (AUPH) 2025 Q3 法說會逐字稿

Good morning. Welcome to the Aurinia Pharmaceuticals third-quarter 2025 conference call. (Operator Instructions)

早安.歡迎參加 Aurinia Pharmaceuticals 2025 年第三季電話會議。（操作說明）

I will now turn the call over to Peter Greenleaf, President and Chief Executive Officer of Aurinia.

現在我將把電話交給奧瑞尼亞公司總裁兼執行長彼得‧格林利夫。

Thank you all for joining us to discuss Aurinia's third-quarter 2025 update. Joining me on the call today are Joe Miller, our Chief Financial Officer; and Dr. Greg Keenan, our Chief Medical Officer.

感謝各位參加本次討論會，共同探討 Aurinia 2025 年第三季的最新進展。今天和我一起參加電話會議的有我們的財務長喬·米勒，以及我們的首席醫療官格雷格·基南博士。

Before we begin our discussion, I'd like to direct your attention to slide 2, which contains important information regarding forward-looking statements. Additionally, we note that on, November 2, Aurinia filed a complaint against Dr. George Tidmarsh arising from his statements about voclosporin. The complaint is pending in the United States District Court for the District of Maryland and is available online. If you have questions regarding the complaint, we refer you to the complaint itself as we will not be commenting further on this matter.

在我們開始討論之前，我想請大家注意第 2 張投影片，其中包含有關前瞻性陳述的重要資訊。此外，我們注意到，11 月 2 日，Aurinia 對喬治·蒂德馬什醫生提起訴訟，起因是他發表了關於沃克洛孢素的言論。該訴訟目前已提交至美國馬裡蘭州地方法院，並可在網上查閱。如果您對投訴有任何疑問，請參閱投訴原文，我們將不再對此事發表評論。

On today's call, we will report third-quarter 2025 financial results and provide an update on recent business progress. We're pleased to report that third-quarter 2025 LUPKYNIS sales experienced continued momentum following last year's inclusion in the American College of Rheumatology lupus nephritis treatment guidelines, growing at a rate of 27% for the quarter year over year.

在今天的電話會議上，我們將公佈 2025 年第三季財務業績，並提供近期業務進展的最新資訊。我們很高興地報告，繼去年被納入美國風濕病學會狼瘡性腎炎治療指南後，2025 年第三季 LUPKYNIS 的銷售額繼續保持增長勢頭，同比增長 27%。

As a result, we're raising LUPKYNIS sales guidance for 2025 for the second time this year to $265 million to $270 million. Further, we have conducted new LUPKYNIS data analyses, which we will share shortly that reinforce LUPKYNIS' robust clinical profile in the treatment of patients with lupus nephritis. And lastly, following the positive Phase I results that were announced in June, we're excited to be advancing aritinercept toward clinical studies in two autoimmune diseases.

因此，我們將 LUPKYNIS 2025 年的銷售預期第二次上調至 2.65 億美元至 2.7 億美元。此外，我們還進行了新的 LUPKYNIS 數據分析，我們很快就會分享這些分析結果，這些分析進一步證實了 LUPKYNIS 在治療狼瘡性腎炎患者方面的強大臨床療效。最後，繼 6 月公佈的積極 I 期臨床試驗的結果之後，我們很高興能夠推進 aritinercept 在兩種自體免疫疾病的臨床研究。

I'd like to turn the call over now to Joe to review our financial results. Joe.

現在我把電話交給喬，讓他來回顧我們的財務表現。喬。

Thank you, Peter. For the third quarter of 2025, total revenue was $73.5 million, up 8% from $67.8 million in the same period of 2024. As a reminder, the 2024 period included a milestone payment of $10 million associated with LUPKYNIS regulatory approval in Japan. Excluding the onetime milestone, total revenue increased by 27% over the same period in 2024.

謝謝你，彼得。2025 年第三季總營收為 7,350 萬美元，比 2024 年同期的 6,780 萬美元成長了 8%。需要提醒的是，2024 年期間包括與 LUPKYNIS 在日本獲得監管批准相關的 1000 萬美元里程碑付款。除去一次性里程碑事件，2024 年同期總收入成長了 27%。

Net product sales of LUPKYNIS were $70.6 million, up 27% from $55.5 million in 2024. Net income was $31.6 million, up 119% from $14.4 million in 2024. Diluted earnings per share was $0.23, up 130% from $0.10 in 2024. Lastly, cash flows from operating activities were $44.5 million, up 162% from $17 million in 2024.

LUPKYNIS 的淨產品銷售額為 7,060 萬美元，比 2024 年的 5,550 萬美元成長了 27%。淨收入為 3,160 萬美元，比 2024 年的 1,440 萬美元成長了 119%。稀釋後每股收益為 0.23 美元，比 2024 年的 0.10 美元增加 130%。最後，經營活動產生的現金流量為 4,450 萬美元，比 2024 年的 1,700 萬美元成長了 162%。

For the nine months ended September 30, 2025, total revenue was $205.9 million, up 17% from $175.3 million in the same period of 2024. Again, the 2024 period included a $10 million milestone payment associated with LUPKYNIS approval in Japan. Excluding the onetime milestone, total revenue increased by 25% over the same period in 2024.

截至 2025 年 9 月 30 日的九個月，總營收為 2.059 億美元，比 2024 年同期的 1.753 億美元成長了 17%。此外，2024 年期間還包括與 LUPKYNIS 在日本獲得批准相關的 1000 萬美元里程碑付款。除去一次性里程碑事件，2024 年同期總收入成長了 25%。

Net product sales of LUPKYNIS were $197.2 million, up 24% from $158.6 million in 2024. Net income was $76.4 million, up 1,677% from $4.3 million in 2024. Diluted earnings per share was $0.55, up 1,733% from $0.03 in 2024.

LUPKYNIS 的淨產品銷售額為 1.972 億美元，比 2024 年的 1.586 億美元成長了 24%。淨收入為 7,640 萬美元，比 2024 年的 430 萬美元成長了 1,677%。稀釋後每股收益為 0.55 美元，比 2024 年的 0.03 美元增加 1733%。

Lastly, cash flows from operating activities were $90 million, up 529% from $14.3 million in 2024. As of September 30, 2025, we have cash, cash equivalents, restricted cash and investments of $351.8 million compared to $315.1 million at June 30, 2025, and $358.5 million at December 31, 2024.

最後，經營活動產生的現金流量為 9,000 萬美元，比 2024 年的 1,430 萬美元成長了 529%。截至 2025 年 9 月 30 日，我們的現金、現金等價物、受限現金和投資為 3.518 億美元，而截至 2025 年 6 月 30 日為 3.151 億美元，截至 2024 年 12 月 31 日為 3.585 億美元。

As previously mentioned, for the three and nine months ended September 30, 2025, cash flows from operating activities were $44.5 million and $90 million, respectively. For the nine months ended September 30, 2025, the company repurchased 12.2 million shares for $98.2 million and diluted shares outstanding were reduced from 149.8 million to 138.2 million.

如前所述，截至 2025 年 9 月 30 日止的三個月和九個月期間，經營活動產生的現金流量分別為 4,450 萬美元和 9,000 萬美元。截至 2025 年 9 月 30 日的九個月內，該公司以 9,820 萬美元的價格回購了 1,220 萬股股票，稀釋後的流通股數量從 1.498 億股減少到 1.382 億股。

As a result of LUPKYNIS' continued momentum, we are pleased to increase our 2025 guidance for the second time this year. For total revenue, we are increasing guidance from a range of $260 million to $270 million to a range of $275 million to $280 million. For net product sales, we are increasing guidance from a range of $250 million to $260 million to a range of $265 million to $270 million.

由於 LUPKYNIS 持續保持成長勢頭，我們很高興今年第二次上調 2025 年業績預期。對於總收入，我們將預期範圍從 2.6 億美元至 2.7 億美元上調至 2.75 億美元至 2.8 億美元。對於淨產品銷售額，我們將預期範圍從 2.5 億美元至 2.6 億美元上調至 2.65 億美元至 2.7 億美元。

Now, I'd like to turn the call over to Greg for some scientific updates. Greg.

現在，我想把電話交給格雷格，讓他帶來一些最新的科學進展。格雷格。

Thank you, Joe. We are pleased to share some new analyses of the results of the clinical studies that form the basis of the FDA's approval of LUPKYNIS. These analyses were recently shared with the FDA in response to an information request.

謝謝你，喬。我們很高興與大家分享一些關於臨床研究結果的最新分析，這些研究結果構成了FDA批准LUPKYNIS的基礎。這些分析報告最近已應美國食品藥物管理局（FDA）的資訊請求提交。

As a reminder, LUPKYNIS was granted full FDA approval based on a statistically significant and clinically meaningful improvement in complete renal response at week 52 and was bolstered with the supplemental NDA with two additional years of evidence. New analyses, which show that LUPKYNIS also was associated with a statistically significant and clinically meaningful reduction in the risk of renal-related events or death, reinforce the robust efficacy and favorable safety profile of LUPKYNIS.

提醒一下，LUPKYNIS 獲得 FDA 完全批准是基於第 52 週腎臟完全反應的統計學顯著性和臨床意義的改善，並透過補充 NDA 獲得了兩年的額外證據。新的分析表明，LUPKYNIS 也與腎臟相關事件或死亡風險的統計學顯著和臨床意義顯著的降低有關，這進一步證實了 LUPKYNIS 的強大療效和良好的安全性。

As you can see from the Kaplan-Meier curve on this slide, LUPKYNIS was associated with a statistically significant and clinically meaningful 53% reduction in the risk of renal-related events or death. This analysis used the AURORA 1 Phase III population. We have included the complete tables contained in our information request response in the appendix of this presentation, which is available on our website.

從這張投影片上的 Kaplan-Meier 曲線可以看出，LUPKYNIS 與腎臟相關事件或死亡風險的統計學顯著性和臨床意義顯著降低 53% 相關。本分析使用了 AURORA 1 III 期族群。我們已將資訊請求回覆中包含的完整表格收錄於本簡報的附錄中，該附錄可在我們的網站上查閱。

Turning to aritinercept, we are very excited about the potential of this novel biologic in the treatment of a wide range of autoimmune diseases. Aritinercept is a dual BAFF/APRIL inhibitor that contains a BCMA-engineered extracellular binding domain optimized for superior affinity to BAFF and APRIL and an IgG4-Fc domain with no appreciable effector function.

談到阿立替尼，我們對這種新型生物製劑在治療多種自體免疫疾病的潛力感到非常興奮。阿立替尼是一種雙重 BAFF/APRIL 抑制劑，它包含一個經 BCMA 工程改造的細胞外結合域，該域針對 BAFF 和 APRIL 的親和力進行了優化，並且還包含一個 IgG4-Fc 域，該域沒有明顯的效應功能。

As a reminder, BAFF and APRIL are cytokines that regulate B cell survival and differentiation with BAFF more targeted at differentiating the mature B cells, and APRIL more targeted plasma cells. By targeting both BAFF and APRIL, aritinercept depletes a broader set of B cells, including plasma cells compared to antibodies such as Benlysta that target only BAFF.

提醒一下，BAFF 和 APRIL 是調節 B 細胞存活和分化的細胞因子，其中 BAFF 更側重於成熟 B 細胞的分化，而 APRIL 更側重於漿細胞的分化。與僅靶向 BAFF 的抗體（如 Benlysta）相比，aritinercept 透過同時靶向 BAFF 和 APRIL，可以清除更廣泛的 B 細胞，包括漿細胞。

In our Phase I study, we enrolled 61 healthy subjects in a standard single ascending dose study design. The study investigated aritinercept at doses of 5, 25, 75, 150, 225 and 300 milligrams and placebo, administered by subcutaneous injection. The study included an expanded cohort of 150 milligrams, which will be our starting dose in our next studies.

在我們的 I 期研究中，我們採用標準的單次遞增劑量研究設計，招募了 61 名健康受試者。該研究調查了皮下注射 5、25、75、150、225 和 300 毫克劑量的阿立替尼和安慰劑。該研究納入了 150 毫克劑量的擴大隊列，這將是我們下一階段研究的起始劑量。

You can see our safety results on this slide. Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade 3 or higher adverse events. There were no treatment-related serious adverse events, and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject were injection site reactions, headaches, upper respiratory tract infections and back pain.

您可以在此投影片上看到我們的安全結果。在所有測試劑量水平下，阿立替尼均具有良好的耐受性。未發生與治療相關的 3 級或以上不良事件。治療期間未發生嚴重不良事件，也未發生因治療相關不良事件而導致的停藥。在多名受試者中發生的不良事件包括注射部位反應、頭痛、上呼吸道感染和背痛。

All injection site reactions were Grade 1. While antidrug antibodies, or ADAs, were detected in the majority of subjects at dose levels of 25 milligrams and higher, the presence of ADAs was not associated with any changes in safety, pharmacokinetic or pharmacodynamic parameters.

所有註射部位反應均為 1 級。雖然在劑量水平為 25 毫克及以上的受試者中檢測到了抗藥性抗體（ADA），但 ADA 的存在與安全性、藥物動力學或藥效學參數的任何變化無關。

On this slide, you can see the pharmacodynamic effects of aritinercept treatment. Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins. Specifically, mean reductions from baseline to day 28 of up to 48%, 55% and 20% were observed for IgA, IgM and IgG, respectively. Importantly, we believe that these long-lasting pharmacodynamic effects support once-monthly dosing.

在這張投影片上，你可以看到阿那西普治療的藥效學效應。單劑量阿立替尼可顯著且持久地降低免疫球蛋白濃度。具體而言，IgA、IgM 和 IgG 從基線到第 28 天的平均減少幅度分別高達 48%、55% 和 20%。重要的是，我們認為這些持久的藥效作用支持每月一次給藥。

With that, I will turn the call over to Peter.

接下來，我將把電話交給彼得。

Thanks, Greg. We're obviously very excited about these results. Aurinia is on track to initiate clinical studies of aritinercept in two autoimmune diseases by the end of 2025. We're very excited about the wide range of therapeutic possibilities for aritinercept and look forward to disclosing further details about our development plan in early 2026.

謝謝你，格雷格。我們顯然對這些結果感到非常興奮。Aurinia 計畫於 2025 年底前啟動阿利替尼治療兩種自體免疫疾病的臨床研究。我們對阿立替尼的廣泛治療可能性感到非常興奮，並期待在 2026 年初公佈有關我們開發計劃的更多細節。

So in summary, we continue to drive growth in the commercial LUPKYNIS business, while, at the same time, advancing the clinical development of aritinercept. We want to thank you all for joining us on today's call, and we look forward to taking your questions.

總而言之，我們持續推動 LUPKYNIS 商業業務的成長，同時推進 aritinercept 的臨床開發。感謝各位參加今天的電話會議，我們期待回答大家的問題。

So now let me ask the operator to open up the line for Q&A. Operator.

現在請接線生開通問答環節。操作員。

(Operator Instructions) Stacy Ku, TD Cowen.

（操作說明）Stacy Ku，TD Cowen。

Congrats on the quarter. If you could put the LUPKYNIS regulatory questions to the side, just given your positive commentary around ACR guidelines and LUPKYNIS use, just hoping you could provide a few metrics maybe around prescriber habits that you're seeing in real time. In addition, obviously, still very early days, but how are clinicians using LUPKYNIS versus Gazyva?

恭喜你本季取得佳績。如果您能暫時把 LUPKYNIS 的監管問題放在一邊，鑑於您對 ACR 指南和 LUPKYNIS 使用的積極評價，我只是希望您能提供一些您實時觀察到的處方習慣方面的指標。此外，顯然現在還處於非常早期的階段，但臨床醫生在使用 LUPKYNIS 和 Gazyva 時有何不同？

Thanks, Stacy. So why don't I start with just giving you a little bit of more qualitative feedback on what we're seeing and why we feel good about the LUPKYNIS business. And then maybe, Greg, you can build in a little bit on that.

謝謝你，史黛西。那麼，不如我先給你們一些關於我們所看到的情況以及我們為什麼對 LUPKYNIS 業務感到滿意的定性回饋。然後，格雷格，或許你可以在此基礎上再深入探討。

If you look at where -- and as we've said previously, we're not going to give down to patient level metrics at this stage of launch because we're now into the fifth year of being on the market, and we think the consistency of our performance somewhat speaks for itself as you look at now consecutive changes in our guidance for the year and year-over-year growth that's been -- and quarter-over-quarter growth that's been fairly consistent.

如果你看看——正如我們之前所說，在產品上市的這個階段，我們不會屈從於患者層面的指標，因為我們現在已經進入市場第五年了，我們認為我們業績的穩定性在某種程度上不言自明，看看我們連續調整的年度和年度增長預期，以及相當穩定的季度增長就知道了。

But to answer your question more directly, our strategy and where we're probably seeing the majority of growth coming from is, one, we, first off, sharpened our commercial focus on high target, high-volume prescribers and primarily in the rheumatologist space, where we have seen each quarter consistent growth in rheumatology new and existing prescribers.

但要更直接地回答您的問題，我們的策略以及我們可能看到的大部分增長來自哪裡，首先，我們加強了對高目標、高處方量的醫生的商業關注，主要是在風濕病領域，我們看到每個季度風濕病新老處方醫生的數量都在持續增長。

Second, we think the ACR guidelines have been truly a wind in our sails. I think this goes for patients. It goes for more new drugs coming into the market. And I think it also applies to both the balance between rheumatologists using the product and nephrologists. But remember, the guidelines themselves are more aggressive on diagnosis criteria. We ask that every patient actually gets a proactive screening, urinalysis on every visit.

其次，我們認為 ACR 指南確實為我們帶來了極大的幫助。我認為這也適用於患者。這種情況也適用於更多上市的新藥。我認為這同樣適用於風濕病學家和腎臟病學家使用該產品之間的平衡。但請記住，指南本身對診斷標準的要求更為嚴格。我們要求每位患者每次就診時都進行主動篩檢和尿液分析。

And then when they do actually hit certain criteria that the treatment with aggressive therapies, triple concomitant immunosuppression be consistent across the board. So whether it's the ACR guidelines, the KDIGO guidelines or recommendations from the nephrology groups, the guideline exercise in terms of what they're at least outlining for the treatment of lupus nephritis has been aggressive.

然後，當他們真正達到某些標準時，治療方案必須採用積極的療法，同時進行三重免疫抑制，並且這種治療方案必須全面一致。因此，無論是 ACR 指南、KDIGO 指南或腎臟科團體的建議，指南制定工作至少在狼瘡性腎炎的治療方面都取得了積極進展。

And then lastly, we continue to see our efficacy profile pulling through for the product, and we continue to see hospital sales growing pretty consistently for us. So Greg, do you want to give any commentary on how -- we don't have any early read on Gazyva, but Greg, being a rheumatologist could probably give some good perspective coming off of the most recent ACR conference. Greg.

最後，我們看到該產品的療效持續顯現，醫院銷售也持續穩定成長。所以 Greg，你有什麼想評論的嗎？我們還沒有關於 Gazyva 的早期信息，但 Greg 作為風濕病學家，可能會根據最近一次 ACR 會議提供一些很好的見解。格雷格。

Yes. Thank you, Peter. So, Stacy, just to close what Peter was saying, at the ACR meeting this year, I think my takeaway was that the clinicians are that much more familiar with the lupus nephritis portion of the SLE management guidelines, and they do very much believe getting aggressive quickly with triple therapy is a key thing. They also, at least in my impression, perceive Gazyva to be something that will replace rituximab in their treatment armamentarium.

是的。謝謝你，彼得。所以，Stacy，我只是想補充Peter剛才說的話，在今年的ACR會議上，我的收穫是，臨床醫生們對SLE管理指南中的狼瘡性腎炎部分更加熟悉了，而且他們非常相信迅速採取積極的三聯療法是關鍵。至少在我看來，他們也認為 Gazyva 將取代利妥昔單抗，成為他們治療方案中的一種藥物。

I'd point out relative to B-cell-mediated treatments such as Benlysta and Gazyva, LUPKYNIS is a T cell-mediated agent as well as helps protect podocytes. So there is a complementarity there going with one doesn't exclude the other.

我想指出的是，與 Benlysta 和 Gazyva 等 B 細胞介導的治療方法相比，LUPKYNIS 是一種 T 細胞介導的藥物，並且有助於保護足細胞。所以它們之間有互補關係，兩者並不衝突。

And then finally, I think in discussions I've had with individual rheumatologists, they are increasingly impressed with the speed with which you can achieve goals with LUPKYNIS relative to B cell modulators, which take longer and also the ability to aggressively taper steroids. So there's a lot of attributes of our drug that are increasingly being thought of as important for the management of lupus nephritis as clinicians increasingly gain familiarity with LUPKYNIS.

最後，我認為在我與一些風濕病學家的討論中，他們越來越對 LUPKYNIS 能夠快速達到治療目標（相比之下，B 細胞調節劑需要更長時間才能起效）以及能夠積極減少類固醇用量的能力印象深刻。隨著臨床醫生對 LUPKYNIS 的了解日益加深，人們越來越認為我們藥物的許多特性對於狼瘡性腎炎的治療至關重要。

Olivia Brayer, Cantor.

奧利維亞·布雷耶，坎托爾。

Can you talk through some of the trends that you're seeing into 4Q so far and just overall level of confidence in continued growth from here, especially thinking through 2026 dynamics? Asking in light, obviously, of Roche's recent approval.

能否談談您目前為止在第四季度觀察到的一些趨勢，以及您對未來持續成長的整體信心，特別是對2026年發展動態的展望？顯然，這是鑑於羅氏最近批准了該申請而提出的。

And then what can you tell us at this point about your APRIL/BAFF program? Have you internally selected which indications you'll be moving forward with and trial design? And if you can't disclose that today, can you tell us how and when you plan to announce your strategy and time lines? And just any feedback from the agency that you've gotten so far from that program?

那麼，您目前能告訴我們一些關於您的 APRIL/BAFF 專案的資訊嗎？你們內部是否已經選定了要推進的適應症和試驗設計？如果您今天無法透露，能否告訴我們您計劃如何以及何時公佈您的策略和時間表？那麼，到目前為止，你從該機構收到了哪些關於該計畫的回饋？

Thanks, Olivia. So first off, we're obviously very pleased with the positive momentum of LUPKYNIS. And then we've had the opportunity to raise guidance for the second time this year. I don't think we see anything inconsistent with that as we now move into the fourth quarter. So as I said, we're obviously very excited with the continued positive momentum we've seen with the product.

謝謝你，奧莉維亞。首先，我們顯然對 LUPKYNIS 的積極發展勢頭感到非常高興。然後，我們有機會在今年第二次提高業績預期。我認為進入第四季度後，我們並沒有發現任何與此相矛盾的地方。正如我所說，我們對該產品持續的積極發展勢頭感到非常興奮。

As to your question around our APRIL/BAFF program, during our call, we mentioned that in the early part of 2026, we -- and we have not given specific guidance as to when. But in the early part of 2026, we look forward to disclosing more about the program.

關於您提出的關於我們 APRIL/BAFF 專案的問題，我們在通話中提到，在 2026 年初，我們將—但我們還沒有給出具體的時間指導。但我們期待在 2026 年初公佈更多關於該計劃的資訊。

Okay. Understood. And maybe if I can just sneak in one more. Anything at ASN this year that we should be focused on from you all?

好的。明白了。或許我還能再偷偷加一個。今年ASN大會上有什麼值得大家關注的事項嗎？

Greg, do you want to -- I mean, outside of the normal LUPKYNIS stuff and anything new we produce with aritinercept as we move forward. But this year --

格雷格，你願意——我的意思是，除了正常的 LUPKYNIS 相關內容以及我們未來使用阿立替尼產生的任何新產品之外。但今年--

Yes. I mean we -- so we just have a couple of presentations talking about use in the real world are our presentations. I think increasingly nephrologists are the bedrock of management for lupus nephritis, and we're looking forward to participating in the meeting and hearing more of their thoughts, but there's nothing terribly notable from our perspective going into ASN this year.

是的。我的意思是，我們——所以我們只有幾個關於在現實世界中使用情況的演示文稿，這就是我們的演示文稿。我認為腎臟科醫生越來越成為狼瘡性腎炎治療的基石，我們期待參加會議並聽取他們更多的想法，但從我們的角度來看，今年參加 ASN 並沒有什麼特別值得注意的地方。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑富瑞。

Congrats on the quarter. Just wondering for the FDA information request, can you say more about what triggered that? I guess, is that related to the Tidmarsh issues or --?

恭喜你本季取得佳績。關於FDA的資訊請求，您能否詳細說明一下是什麼觸發了這項請求？我猜，這和提德馬什的問題有關嗎？——？

We can't speak specifically to why we received an information request from the FDA. But I think as you can see through the slide deck and through our comments, through the actual commentary that we did during our actual call today, the data that we've disclosed and is out there publicly is actually quite favorable for the product.

我們無法具體說明為什麼會收到 FDA 的資訊請求。但我認為，正如您從幻燈片和我們的評論中，以及我們今天在電話會議上所做的實際評論中看到的那樣，我們已經披露並公開的數據實際上對該產品相當有利。

Greg, do you have any additional comments?

格雷格，你還有其他補充說明嗎？

Yes. I'd just say that the FDA's prerogative is to ask for comments and questions at any time. And concurrent with that, I'll just point out to slightly different way than we've looked at our data before.

是的。我只想說，FDA的特權在於隨時徵求意見和問題。同時，我還要指出一種與我們之前查看數據略有不同的方法。

But to Peter's point, the evidence is very favorable, and that was one of the reasons why we wanted to share this specific set of results with the community as we have sent this all back to the FDA as well for their consideration.

但正如彼得所說，證據非常有利，這也是我們想與大家分享這組具體結果的原因之一，因為我們也已將所有這些結果提交給 FDA 供其考慮。

Okay. Understood. And for aritinercept, can you clarify if you're in a MAD phase with healthy volunteers? And would you report more data in early 2026 along with the selected indications?

好的。明白了。至於阿立替尼，您能否說明一下，您是否正在進行針對健康志願者的多因素藥物試驗（MAD）階段？您能否在 2026 年初公佈更多數據以及選定的適應症？

As we've said, we're going into two autoimmune diseases, moving into two autoimmune diseases. And then on the back end of that, that we would disclose in early 2026 more details on those programs, Maury.

正如我們所說，我們將深入探討兩種自體免疫疾病。莫里，之後我們會在 2026 年初公佈這些項目的更多細節。

Okay. Are you in MAD dosing though, with the healthy volunteers or is that --?

好的。你是和健康志願者一起進行MAD劑量試驗嗎？還是另有其他原因？——？

We're in the process. And I think in order to achieve the objectives we've laid out in the call, we would have to be moving into that phase.

我們正在進行中。我認為，為了實現我們在電話會議中提出的目標，我們必須進入那個階段。

Joseph Schwartz, Leerink Partners.

Joseph Schwartz，Leerink Partners。

This is Will on for Joe. Congrats on a strong quarter here. I have one question on the FDA request and then one on AUR200. So just to start on the request, do you expect a response from the FDA? Just curious about that.

我是威爾，替喬報道。恭喜你們本季業績出色。我有一個關於 FDA 請求的問題，還有一個關於 AUR200 的問題。那麼，首先關於您的請求，您預計會收到 FDA 的回覆嗎？只是好奇而已。

And then for AUR200, I can appreciate that you guys are going to provide additional updates in early 2026 on that. But could you just help us give us a little bit more information on the process of selecting these indications and perhaps the puts and takes of choosing one or the other? Any color there would be helpful.

至於 AUR200，我很欣賞你們將在 2026 年初提供更多相關資訊。您能否幫我們詳細介紹選擇這些指標的過程，以及選擇其中一個或另一個指標的優缺點？任何顏色都會有所幫助。

Thanks, Will. Well, let me first just reinforce one more time that we received and responded to an information request regarding LUPKYNIS. To reinforce, this data set contained our responses included in the slides in your deck that has been posted on our K, 11, 21 and 22 of today's presentation. It is also available on our website.

謝謝你，威爾。首先，我再次強調一下，我們已經收到並回覆了有關 LUPKYNIS 的資訊請求。為了強調這一點，該資料集包含了我們今天簡報中幻燈片所包含的回复，這些回复已發佈在我們的 K、11、21 和 22 號簡報中。您也可以在我們的網站上找到它。

The data contains measurement requested by the FDA, and each of these measurements is defined by the FDA, what the FDA actually requested. As you can see, if you look at these slides and these analyses, you'll see that we actually had new data, at least in terms of presenting that new data. We had a 53% reduction in risk of renal-related events and/or death.

數據包含 FDA 要求的測量數據，而每項測量數據都是由 FDA 定義的，即 FDA 實際要求的測量數據。如你所見，如果你看看這些投影片和這些分析，你會發現我們實際上有了新的數據，至少在展示這些新數據方面是如此。腎臟相關事件和/或死亡的風險降低了 53%。

We think this reinforces the robust efficacy and favorable safety profile of the product. We can't determine and/or predict whether the FDA will have more questions. As Greg just mentioned, FDA holds the ability to ask questions whenever they want, but we think this request and response was actually quite favorable.

我們認為這進一步證實了該產品的強大功效和良好的安全性。我們無法確定和/或預測FDA是否還會提出更多問題。正如 Greg 剛才提到的，FDA 有權隨時提出問題，但我們認為這次的請求和答覆其實相當有利。

In terms of disclosure of how -- and what we were getting about in terms of the indications for aritinercept, I think just like any company when looking at different indications, you have to think about how we think APRIL/BAFF could play a role in the disease, one. The unmet medical need in each one of these major disease areas. And I think you have to connect that back somewhat to how we think APRIL/BAFF play or do not play a role in those diseases.

關於揭露我們如何以及我們在阿立替尼適應症方面所取得的進展，我認為就像任何公司在考慮不同適應症時一樣，你必須考慮我們認為 APRIL/BAFF 可能在疾病治療中發揮的作用。這些主要疾病領域中尚未滿足的醫療需求。我認為你必須把這一點與我們認為 APRIL/BAFF 在這些疾病中發揮或不發揮的作用聯繫起來。

And probably third, market size, of course, and probability of success. These are all the normal things that any company would think about when going into these indications. And I can just tell you that these are all things that we've considered, and we look forward to disclosing more as we enter 2026 and beyond.

第三，當然還有市場規模和成功機率。這些都是任何公司在考慮這些適應症時都會正常考慮的事情。我可以告訴大家，這些都是我們已經考慮過的因素，我們期待在 2026 年及以後公佈更多資訊。

Arthur He, H.C. Wainwright.

何亞瑟，H.C. 溫賴特。

Congrats on another strong quarter. So just a couple of quick ones. So first of all, so traditionally, fourth quarter will be the strongest quarter for you guys. I'm just curious what possible holdback or risk-wise can prevent you guys to outbeat the fourth quarter?

恭喜又一個季度業績出色。就簡單問幾個問題。首先，按照慣例，第四季對你們來說通常是業績最好的季度。我只是好奇，在第四節比賽中，有哪些可能的阻礙或風險會阻止你們取得好成績？

And regarding the impact from the ACR guidance, what's your thinking about the impact or the positive impact from that? It's more like first couple of innings or getting in the middle of -- I don't think it's getting late innings yet.

關於ACR指南的影響，您認為它會帶來哪些影響，或說會產生哪些正面影響？更像是比賽的前幾局或是進行到中段——我覺得還沒到比賽的後半段。

Well, thanks for the question, Arthur. First off, on the ACR guidelines, and this is not necessarily, and I welcome Greg's commentary here because we've done this at a couple of companies with a couple of drugs in different categories as it relates to rheumatologists and other diseases, but specifically rheumatologists.

謝謝你的提問，亞瑟。首先，關於 ACR 指南，這並不一定，我歡迎 Greg 在這裡發表評論，因為我們在幾家公司針對不同類別的幾種藥物做過類似的事情，這與風濕病學家和其他疾病有關，但特別是與風濕病學家有關。

The guidelines -- I mean, listen, they're written the way we think the evidence drives they should be written, and they're quite positive for patients and quite positive probably for our drug and other drugs. They take time. Physician treatment behaviors don't change overnight. And I think we're seeing positive momentum, but I think that positive momentum will only continue to improve over time with better diagnosis rates and better treatment rates that better align to those guidelines.

這些指南——我的意思是，聽著，它們是按照我們認為證據所驅動的方式編寫的，它們對患者來說非常積極，對我們的藥物和其他藥物也可能非常積極。這需要時間。醫生的治療行為不會在一夜之間改變。我認為我們正在看到積極的勢頭，但隨著診斷率和治療率的提高，以及與這些指南的更加一致，這種積極的勢頭只會隨著時間的推移而繼續改善。

Your first question related to the guidance that we've given for the year in the first and the fourth quarter. You're right. Historically, that has been the trend for our product. I think we have been in a mode of wanting to ensure that we give a guidance range that we intend to hit and/or beat. And I think that's what you've seen in our guidance range of $265 million to $270 million for the full year.

您的第一個問題與我們在第一季和第四季給出的年度業績指引有關。你說得對。從歷史上看，這一直是我們產品的趨勢。我認為我們一直致力於確保給予的指導範圍是我們打算達到和/或超越的範圍。我認為，這與我們全年2.65億美元至2.7億美元的業績預期範圍相符。

And I think that's all we're going to comment on at this stage of the game, Arthur. Thank you for the question.

亞瑟，我想在這個階段我們就只評論這些了。謝謝你的提問。

Maybe just a quick one regarding the BAFF/APRIL program. Given in the space, multiple players came in and also angle differently in terms of indication-wise, given the history of the company and strong suit from you guys, have you contemplating a non-kidney indication? Or you can give us more color later on?

關於BAFF/APRIL項目，我只想簡單提一下。鑑於該領域湧現出眾多參與者，並且在適應症方面也各有側重，考慮到公司的歷史和你們的優勢，你們有沒有考慮過非腎臟適應症？或者您之後可以補充更多資訊？

What I can tell you is we take into account strategically the fact that we have a focus on rheumatology. I mean, I think often we forget lupus is treated by rheumatologists; and lupus nephritis, while it is a separate condition, it is an associated condition with lupus.

我可以告訴你們的是，我們在戰略上考慮到了我們專注於風濕病學這一事實。我的意思是，我們常常忘記狼瘡是由風濕病學家治療的；而狼瘡性腎炎雖然是一種獨立的疾病，但它是狼瘡的一種相關疾病。

So our concentration is rheumatologists and nephrologists. So I think you can feel comfortable that we take into account both of those, nephrology and rheumatology. And I guess I would just conclude too, that we're not blind to the fact that an APRIL/BAFF inhibitor, we believe, has every ability to work in a multitude of different diseases.

所以我們主要關注風濕病學家和腎臟病學家。所以我認為您可以放心，我們會同時考慮到腎臟病學和風濕病學這兩個方面。我想我也可以得出這樣的結論：我們並非對這樣一個事實視而不見，我們相信 APRIL/BAFF 抑制劑完全有能力治療多種不同的疾病。

And we've mentioned historically that our internal work has shown upwards of 20-plus indications that could be affected through further development in this class and area of drugs. So we're not boxed in, Arthur, in our thinking to just rheumatology and nephrology. And as I said, we look forward to sharing more about that as we move into 2026 and beyond.

我們之前也提到過，我們的內部研究表明，透過進一步開發此類藥物，可以改善 20 多種適應症。所以，亞瑟，我們的思維並不限於風濕病學和腎臟病學。正如我所說，我們期待在 2026 年及以後與大家分享更多相關資訊。

David Martin, Bloom Burton.

大衛馬丁，布魯姆伯頓。

You did a great job of describing all the positive drivers bringing new patients on to LUPKYNIS. I'm wondering, are you seeing positive trends in persistence? Are the patients staying on it longer?

你出色地描述了所有促使新患者選擇 LUPKYNIS 的積極因素。我想知道，您是否觀察到堅持性方面出現正面趨勢？患者服用該藥的時間是否更長了？

Yes, David, we've seen an upward trend in persistency that directly aligned to when we published, issued the data around the extension trial and the subsequent data around the biopsy sub-study. I mean, you've been covering us for a long time, and I think you know this area quite well.

是的，David，我們已經看到持續性呈上升趨勢，這與我們發布擴展試驗數據以及隨後發布的活檢子研究數據的時間直接吻合。我的意思是，你報道我們這裡已經很久了，我想你對這個地區非常了解。

Obviously, calcineurin inhibitors are new for -- not new because they understand the class of drugs, but rheumatologists in their day-to-day practice don't use calcineurin inhibitors as often or as aggressively as nephrologists do. So I think these data sets showing that we had safety and efficacy and that the drug was well tolerated all the way out to three years in the AURORA study and then subsequently to have an 18-month biopsy confirmed sub-study of that study to show that not only was there no negative effect on kidney function as measured through eGFR and histology, but that it looked like it could have some at least balancing effect, if not improvement effect on those patients.

顯然，鈣調神經磷酸酶抑制劑對風濕病學家來說是新的——不是因為他們不了解這類藥物，而是風濕病學家在日常實踐中不像腎臟科醫生那樣頻繁或積極地使用鈣調神經磷酸酶抑制劑。所以我認為這些數據集表明，我們在 AURORA 研究中獲得了安全性和有效性，而且該藥物在長達三年的時間內耐受性良好。隨後，一項為期 18 個月的活檢證實子研究表明，該藥物不僅沒有對腎功能產生負面影響（透過 eGFR 和組織學測量），而且似乎至少對這些患者有一定的平衡作用，甚至可能具有改善作用。

All have been very helpful in terms of the comfort level of rheumatologists and nephrologists continuing to keep patients on drug over longer periods of time. I don't think any of those changes have hit a materiality sort of level, but I can tell you that they've not declined and they continue to improve over time.

所有這些措施都極大地幫助了風濕病學家和腎臟病學家，使他們能夠更輕鬆地讓患者長期服用藥物。我認為這些變化都還沒有達到實質的程度，但我可以告訴你，它們並沒有退步，而且隨著時間的推移，它們還在不斷進步。

Doug Miehm, RBC Capital Markets.

道格‧米姆，加拿大皇家銀行資本市場。

Congrats on the quarter. Just one question from me on aritinercept. Peter, are you contemplating bringing the 150? I want to make sure I heard that or the 225 ahead in the clinical trial program in terms of what you're going to dose?

恭喜你本季取得佳績。關於阿那西普，我只有一個問題。彼得，你有考慮帶那輛150嗎？我想確認一下，我聽到的是指臨床試驗計畫中的225位受試者，還是指你們的給藥劑量？

Yes. We've not sent out the exact way we intend to structure these trials. And as I said, look, we look forward to sharing more about that in the future. But I don't know, Greg, if you want to -- I mean, obviously, the 150 and above seem to hit the mark. But Greg, do you have anything?

是的。我們尚未公佈我們計劃如何組織這些試驗的具體方案。正如我所說，我們期待在未來分享更多相關資訊。但我不知道，格雷格，如果你想的話——我的意思是，很明顯，150及以上的似乎都達到了目標。格雷格，你有什麼嗎？

Well, that way, we were just trying to provide a little bit more color on our confidence that we have a dose that ought to be efficacious relative to what we've seen with regard to pharmacodynamic marker changes. So we indicated in our prepared statement that 150-milligram dosing will be one of the dosing levels that we'll use going forward. But of course, we're embarking on kind of multiple ascending dose studies, so we'll have higher doses as well. But what we indicated was 150 is definitely viable and we're taking that forward.

嗯，那樣的話，我們只是想更詳細地說明我們對該劑量的信心，即根據我們觀察到的藥效學標誌物變化，該劑量應該是有效的。因此，我們在事先準備好的聲明中指出，150毫克劑量將是我們今後將使用的劑量水平之一。當然，我們正在進行多輪遞增劑量研究，所以我們也會使用更高的劑量。但我們之前提到的 150 人肯定是可行的，我們正在推進這個方案。

Okay. Because I just have a follow-up question then. So the 150 is where you had the expanded cohort, seems to be on a risk-reward basis, maybe one of the more attractive levels. I'm just wondering why then when you look at the data that you provided versus the competitive products, you were calling out the 225 versus the 150? And the 225 does look better than everything else, all measures that we can see here. But I'm just wondering why you weren't providing the 150 in terms of those data.

好的。因為我還有一個後續問題。所以 150 這個價位是擴大了目標群體的價位，從風險報酬的角度來看，這可能是比較有吸引力的價位之一。我只是想知道，為什麼當你查看你提供的數據與競爭產品的數據時，你會特別提到 225 而不是 150 呢？從我們這裡可以看到的所有指標來看，225 的確比其他所有車型都要好。但我只是想知道為什麼你沒有提供那 150 個數據。

Well, I think it's a great question. And I think it gets to wanting to understand at a deeper level how we intend to go forward with the multi-ascending dose study and/or studies that will help us better understand and tease out what the exact dose we're going to want to be going forward with when we move into even further clinical development studies.

嗯，我覺得這是一個很好的問題。我認為，關鍵在於要更深入地了解我們打算如何推進多劑量遞增研究和/或相關研究，以幫助我們更好地理解和確定在進一步開展臨床開發研究時，我們想要的確切劑量是什麼。

So your question, I think, is appropriately -- it's a good one. But at this stage of the game, we're not disclosing all of those details, and we look forward to disclosing them in 2026. So thank you for the question.

所以，我認為你的問題問得恰到好處——這是一個很好的問題。但現階段，我們不會透露所有細節，我們期待在 2026 年透露這些細節。謝謝你的提問。

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Peter Greenleaf for closing remarks.

女士們、先生們，問答環節到此結束。現在，我想把電話轉回給彼得‧格林利夫，請他作總結發言。

Thank you very much, everyone, for joining us on today's call. We're excited about the momentum we've seen now through three quarters of the year, and we look forward to providing details on year-end and 2026 in our next call. Have a great day. Thank you very much.

非常感謝各位參加今天的電話會議。我們對今年前三個季度取得的良好勢頭感到興奮，並期待在下次電話會議上提供有關年底和 2026 年的詳細資訊。祝你有美好的一天。非常感謝。

Thank you. This concludes today's conference. You may disconnect your lines at this time and have a wonderful day.

謝謝。今天的會議到此結束。現在您可以斷開線路了，祝您有美好的一天。