Aurinia Pharmaceuticals Inc (AUPH) 2025 Q2 法說會逐字稿

Greetings and welcome to the Aurinia Pharmaceuticals second quarter 2025 earnings call. (Operator Instructions)

問候並歡迎參加 Aurinia Pharmaceuticals 2025 年第二季財報電話會議。（操作員指示）

I would now like to turn the conference over to your host, Joe Miller, Chief Financial Officer for Aurinia. Thank you. You may begin.

現在，我想將會議交給主持人、Aurinia 財務長喬·米勒 (Joe Miller)。謝謝。你可以開始了。

Thank you, operator, and thank you everyone for joining today's webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's President and Chief Executive 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 總裁兼首席執行官 Peter Greenleaf 和 A​​urinia 首席醫療官 Greg Keenan 博士。

Today we will review and discuss Aurinia's second 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 年第二季度的財務業績，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當局提交的文件，這些文件也可在 Aurinia 的網站 auriniapharma.com 上查閱。

During today's call, Aurinia may make forward-looking statements based on current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and actual results may differ materially. For a discussion of factors that could affect Aurinia's future financial results in business, please refer to the disclosures in Aurinia's press release, quarterly report on Form 10Q, and all other filings with the US Securities and Exchange Commission and Canadian securities authorities.

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。這些前瞻性陳述受到許多重大風險和不確定性的影響，實際結果可能有重大差異。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、10Q 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的披露內容。

Please note that all statements made during today's call are current as of today, July 31, 2025, unless otherwise noted and are based upon information currently available to us.

請注意，除非另有說明，今天電話會議中所做的所有陳述都是截至 2025 年 7 月 31 日的最新陳述，並且基於我們目前掌握的資訊。

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?

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, Joe, 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 second quarter results and provide an update on all corporate initiatives. I'll then turn the call back over to Joe to provide additional detail on our financial results.

謝謝，喬，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，我將介紹我們第二季的業績以及所有公司計劃的最新情況。然後我會將電話轉回給喬，以提供有關我們財務結果的更多詳細資訊。

We continue to achieve strong growth in total revenue and net product sales in the three and six months ended June 30, 2025. For the three months and six months ended June 30, 2025, total revenue was $70 million and $132.5 million, up 22% and 23% respectively from $57.2 million and $107.5 million respectively in the same periods of 2024.

截至 2025 年 6 月 30 日的三個月和六個月內，我們的總營收和淨產品銷售額持續實現強勁成長。截至 2025 年 6 月 30 日的三個月和六個月，總收入分別為 7,000 萬美元和 1.325 億美元，分別比 2024 年同期的 5,720 萬美元和 1.075 億美元成長 22% 和 23%。

For the three and six months ended June 30, 2025, net product sales of LUPKYNIS, the first FDA approved oral therapy for the treatment of adult patients with active lupus nephritis or LN, were $66.6 million and $126.5 million, up 21% and 23% respectively, from $55 million and $103.1 million in the same periods of 2024.

截至 2025 年 6 月 30 日的三個月和六個月，LUPKYNIS（FDA 批准的首個用於治療活動性狼瘡性腎炎或 LN 成人患者的口服療法）的淨產品銷售額分別為 6,660 萬美元和 1.265 億美元，分別比 2024 年同期的 5,5000 萬美元和 1.21% 21.21 億美元。

The increase for both periods is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies driven by further LN market penetration. For the six months ended June 30, 2025, cash flow generated from operations was $45.5 million. This is compared to a negative $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million in cash payments made in 2025 in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the six months ended June 30, 2025.

這兩個時期的成長主要是由於 LN 市場進一步滲透，導致向專業藥局銷售的 LUPKYNIS 紙盒數量增加。截至 2025 年 6 月 30 日的六個月，經營活動產生的現金流量為 4,550 萬美元。相較之下，2024 年同期營運現金流為負 280 萬美元。不包括 2025 年與 2024 年 11 月重組相關的 1,150 萬美元現金支付，截至 2025 年 6 月 30 日的六個月內，經營活動產生的現金流為 5,700 萬美元。

As of June 30, 2025, we have cash, cash equivalents, restricted cash and investments of $315.1 million. This is compared to $358.5 million at December 31, 2024. For the six months ended June 30, 2025, the company repurchased 11.2 million of its common shares for $90.8 million including commissions and excise tax.

截至 2025 年 6 月 30 日，我們的現金、現金等價物、受限現金和投資為 3.151 億美元。相較之下，2024 年 12 月 31 日為 3.585 億美元。截至 2025 年 6 月 30 日的六個月內，該公司以 9,080 萬美元（包括佣金和消費稅）回購了 1,120 萬股普通股。

As a result of the sustained growth we've seen in the first half of 2025, we are increasing our full year 2025 total revenue guidance from a range of $250 million to $260 million to a range of $260 million to $270 million and our net product sales guidance from a range of $240 million to $250 million to a range of $250 million to $260 million.

由於我們在 2025 年上半年看到了持續的成長，我們將 2025 年全年總收入預期從 2.5 億美元至 2.6 億美元提高到 2.6 億美元至 2.7 億美元，並將淨產品銷售額預期從 2.4 億美元至 2.5 億美元提高到 2.5 億美元至 2.6 億美元。

Finally, we reported positive results from our aritinercept Phase 1 single ascending dose study on June 30, 2025. Aritinercept is a dual BAFF, APRIL inhibitor. It contains a BCMA engineered extracellular binding domain that's optimized for superior affinity to APRIL and BAFF. We remain on track to initiate further clinical studies for aritinercept and at least two autoimmune diseases in the second half of this year. We are very excited about the wide range of therapeutic possibilities for aritinercept , but for competitive reasons, we'll not be disclosing further detail about our future plans at this time.

最後，我們在 2025 年 6 月 30 日報告了阿替西普第 1 階段單次遞增劑量研究的正面結果。Aritinercept 是一種雙重 BAFF、APRIL 抑制劑。它包含一個 BCMA 設計的細胞外結合域，該域經過最佳化，對 APRIL 和 BAFF 具有卓越的親和力。我們仍計劃在今年下半年啟動阿替西普和至少兩種自體免疫疾病的進一步臨床研究。我們對阿替西普廣泛的治療可能性感到非常興奮，但出於競爭原因，我們目前不會透露更多有關未來計劃的細節。

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

現在，我想將電話轉回給喬，以便更詳細地審查 2025 年第二季的財務業績。通話結束後，我會回來快速回顧一下，並解答大家可能提出的任何問題。喬？

Thank you, Peter. Let's take a few minutes to discuss the second quarter of 2025 financial results.

謝謝你，彼得。讓我們花幾分鐘討論一下 2025 年第二季的財務表現。

For the three and six months ended June 30, 2025, total revenue was $70 million and $132.5 million, up 22% and 23% respectively, from $57.2 million and $107.5 million in the comparable periods of 2024.

截至 2025 年 6 月 30 日的三個月和六個月，總收入分別為 7,000 萬美元和 1.325 億美元，較 2024 年同期的 5,720 萬美元和 1.075 億美元分別增長 22% 和 23%。

As Peter mentioned, we had cash, cash equivalents, restricted cash and investments of $315.1 million as of June 30, 2025, and generated cash flows from operations of $45.5 million compared to $2.8 million in cash flow used in operations in the same period of 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57 million for the six months ended June 30, 2025.

正如彼得所提到的，截至 2025 年 6 月 30 日，我們的現金、現金等價物、受限現金和投資為 3.151 億美元，經營活動產生的現金流為 4,550 萬美元，而 2024 年同期經營活動使用的現金流為 280 萬美元。不包括與 2024 年 11 月重組相關的 1,150 萬美元現金支付，截至 2025 年 6 月 30 日的六個月內，經營活動產生的現金流為 5,700 萬美元。

We are continuing to be opportunistic with our share repurchase plan and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand. The company repurchased 18.3 million of its common shares for $138.4 million excluding commissions and excise tax since the launch of the program in the first quarter of 2024 through today.

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任何未來的自由股票回購提供資金。自 2024 年第一季啟動該計畫以來，截至今天，該公司已回購了 1,830 萬股普通股，回購金額為 1.384 億美元（不含佣金和消費稅）。

Additionally, today we announced that the Board has approved an increase in the share repurchase plan of up to an additional $150 million of common shares over the initially approved $150 million Board authorization.

此外，今天我們宣布，董事會已批准將股票回購計畫增加至多 1.5 億美元的普通股，而董事會最初授權的金額為 1.5 億美元。

For the three and six months ended June 30, 2025, cost of revenue was $7.1 million and $15.7 million respectively compared to $8.9 million and $16.7 million in the comparable periods in 2024. The decrease for both periods is primarily due to a decrease in sales of LUPKYNIS inventory to Otsuka, which is sold under a cost-plus arrangement and has a lower gross margin than our other sales.

截至 2025 年 6 月 30 日的三個月和六個月，收入成本分別為 710 萬美元和 1,570 萬美元，而 2024 年同期分別為 890 萬美元和 1,670 萬美元。這兩個期間的下降主要是由於 LUPKYNIS 庫存對大塚的銷售額減少，該銷售額是根據成本加成協議出售的，其毛利率低於我們的其他銷售。

For the three and six months ended June 30, 2025, gross margin was 90% and 88% respectively compared to 84% and 85% the same periods in 2024. For the three and six months ended June 30, 2025, total operating expenses were $49.9 million and $90.5 million respectively compared to $58.7 million and $122.3 million in the comparable periods of 2024. The decrease for both periods is primarily due to lower personnel expenses, including share-based compensation and overhead costs, as a result of our strategic restructuring efforts in 2024. This was partially offset by an increase in R&D-related expenses as we continue to advance our development activities for aritinercept and voclosporin 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.

截至 2025 年 6 月 30 日的三個月和六個月，毛利率分別為 90% 和 88%，而 2024 年同期分別為 84% 和 85%。截至 2025 年 6 月 30 日的三個月和六個月，總營運費用分別為 4,990 萬美元和 9,050 萬美元，而 2024 年同期分別為 5,870 萬美元和 1.223 億美元。這兩個期間的下降主要是由於我們 2024 年的策略重組努力導致人事費用（包括股權激勵和管理費用）降低。由於我們繼續推動阿替西普和沃氯孢素的開發活動，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 June 30, 2025, net income was $21.5 million or $0.16 of earnings per share compared to $722,000 or $0.01 of earnings per share in the same period of 2024. For the six months ended June 30, 2025, net income was $44.9 million or $0.33 of earnings per share compared to a net loss of $10 million or $0.07 net loss per share in the same period of 2024.

截至 2025 年 6 月 30 日的三個月，淨收入為 2,150 萬美元，即每股收益 0.16 美元，而 2024 年同期淨收入為 722,000 美元，即每股收益 0.01 美元。截至 2025 年 6 月 30 日的六個月，淨收入為 4,490 萬美元，即每股收益 0.33 美元，而 2024 年同期的淨虧損為 1,000 萬美元，即每股淨虧損 0.07 美元。

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

說完這些，我想把電話交還給彼得，讓他做一些結束語。彼得。

Thanks, Joe.

謝謝，喬。

In summary, we continue to drive growth in the commercial LUPKYNIS business, move forward with the clinical development of aritinercept, and maintain excellent operational efficiency. I want to thank you all for your time today.

綜上所述，我們持續推動商業LUPKYNIS業務的成長，推動阿替西普的臨床開發，並維持卓越的營運效率。我要感謝大家今天抽出時間。

We'll now open the lines for any questions you may have. Operator?

我們現在將開放熱線來回答您的任何問題。操作員？

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions). Stacy Ku, TD Cowen.

謝謝。我們現在將進行問答環節。（操作員指令）。史黛西·庫 (Stacy Ku)，考恩 (Cowen) TD。

Thanks. Hi, team. This is Vish on for Stacy. Congrats on a great quarter and thanks for taking our questions.

謝謝。大家好。這是 Vish 為 Stacy 拍攝的。恭喜您本季的優異成績，感謝您回答我們的問題。

So you reported some encouraging data for aritinercept, and I understand that you're not, for competitive reasons disclosing any details, but could you at least guide us to how you were thinking about the potential for aritinercept? Where do you think it could generate or add the most value so that us and investors could appreciate how you're thinking about the development? And based on the PK/PD data from the SAD study, how are you thinking about maybe potentially doses to be moved forward for the POC studies? Thanks, and I have one follow-up.

因此，您報告了一些有關阿替西普的令人鼓舞的數據，我知道出於競爭原因您不會透露任何細節，但您能否至少告訴我們您是如何看待阿替西普的潛力的？您認為它可以在哪些方面產生或增加最大價值，以便我們和投資者了解您對開發的看法？根據 SAD 研究的 PK/PD 數據，您認為如何進一步提高 POC 研究的劑量？謝謝，我還有一個後續問題。

Yeah, I mean, I'll start now, and I'll ask Greg to jump in where I might miss or where he sees some add-on here. Listen, I think the potential of these B cell mediated diseases and APRIL BAFF's potential ability to affect these B cell mediated diseases is apparent today, obviously in the data that's been rolled out in areas like ligand. But we as a company have done our own assessment internally. We think there's upwards of 20 to -- north of 20 different B cell mediated diseases that you could look at for, potentially for these for these compounds.

是的，我的意思是，我現在就開始，然後我會請格雷格介入我可能錯過的地方，或者他在這裡看到的一些附加內容。聽著，我認為這些 B 細胞介導疾病的潛力以及 APRIL BAFF 影響這些 B 細胞介導疾病的潛在能力今天已經顯而易見，這顯然體現在配體等領域推出的數據中。但我們作為一家公司已經在內部進行了自己的評估。我們認為，有超過 20 種不同的 B 細胞介導疾病需要研究，這些疾病可能與這些化合物有關。

So, while we're not disclosing exactly where we're going in our exact approach for competitive reasons at this stage, know that we see a pretty wide-open field in terms of other areas that could potentially be addressed even outside of the kidney indications that have been explored to date.

因此，雖然出於競爭原因，我們現階段不會透露我們的具體方法，但要知道，除了迄今為止探索的腎臟適應症之外，我們還看到了其他領域相當廣闊的潛力。

So we'll look forward to talking more about that in the future, but at this point, as we've said, we're not disclosing for competitive purposes, but no, we're looking at a range of indications. Greg, you want to talk maybe a little bit about the dose side of the single ascending dose study?

因此，我們期待在未來就此進行更多討論，但目前，正如我們所說，我們不會出於競爭目的而披露信息，但是，我們正在考慮一系列跡象。格雷格，你想談談單次遞增劑量研究的劑量方面嗎？

Sure, thank you, Peter. Yes, well, based on the evidence from the single ascending dose study, we're very confident now that a two four-week dosing schedule is justified, with the evidence, especially with regard to kinetics, the pharmacokinetics. And the pharmacodynamics of that that we've demonstrated with a single kinetics dose. So, we think two four-week dosing will be something we can explore and confidently be able to demonstrate some important evidence as we move forward into the multiple ascending dose studies.

當然，謝謝你，彼得。是的，根據單次遞增劑量研究的證據，我們現在非常有信心，兩個四週的給藥方案是合理的，並且有證據，特別是關於動力學和藥物動力學的證據。我們已經透過單次動力學劑量證明了其藥效動力學。因此，我們認為，我們可以探索兩次為期四週的給藥，並且在進行多次遞增劑量研究時，我們有信心證明一些重要的證據。

Got it. Thank you. And then my follow-up was on LUPKYNIS actually. Clearly, the sales are doing well and your guidance. So can you just detail some effects that you are seeing of the updated ACR guidelines on LUPKYNIS adoption, maybe discuss how rheumatology versus nephrology prescribing is going, and what that looks like right now? Thanks.

知道了。謝謝。然後我的後續行動實際上是關於 LUPKYNIS 的。顯然，銷售情況良好，也得到了您的指導。那麼，您能否詳細說明一下更新後的 ACR 指南對 LUPKYNIS 採用的一些影響，或許可以討論一下風濕病學和腎臟病學處方的進展情況，以及目前的情況如何？謝謝。

Yeah, I think we're encouraged by the guidelines, and I think two evidence points, I guess I would give you that the guidelines are having some impact, albeit they're not quantitative.

是的，我認為我們受到了指導方針的鼓舞，我認為有兩個證據可以證明這些指導方針正在產生一些影響，儘管它們不是量化的。

They'll give you a directional feel for how they're impacting our business. We've seen a really strong uptick in the number of rheumatology prescribers. I mean, the guidelines themselves alongside of, we've got the two-year extension of the original AURORA study that's been out there with the biopsy sub study that was published in a rheumatology journal. I think that in combination with the guidelines has driven higher prescribing that we're seeing in rheumatology offices, so an increase there.

它們會讓您直觀地感受到它們對我們的業務有何影響。我們發現風濕病處方數量大幅增加。我的意思是，除了指南本身之外，我們還對最初的 AURORA 研究進行了為期兩年的延長，該研究與發表在風濕病學雜誌上的活檢子研究一起進行。我認為，結合指南，風濕病診所的處方量增加，因此處方量增加。

And then in addition we're seeing an increase in our hospital business, and I think that's a direct reflection of the academic setting and, fellows and teaching institutions adopting those guidelines and using them more proactively.

此外，我們還看到醫院業務的成長，我認為這直接反映了學術環境以及研究員和教學機構採用這些指導方針並更積極地使用它們。

So, while it's not a quantitative answer, it can give you a really good feel for how we think they're impacting. Rheumatologists are using more of our drug. They're growing at a faster rate than nephrologists right now. And then in addition, our hospital business has been growing in a healthy way since the guidelines have been published.

因此，雖然這不是一個定量的答案，但它可以讓你很好地了解我們認為它們的影響。風濕病學家正在更多地使用我們的藥物。目前，他們的成長速度比腎臟病專家還要快。此外，自從指南發布以來，我們的醫院業務一直在健康成長。

Got it. Thank you very much.

知道了。非常感謝。

Thanks, Vish.

謝謝，維什。

Maury Raycroft, Jefferies.

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

Hi, this is James on for Maury. Congrats on the progress and thank you for taking our questions. Just another question on LUPKYNIS and I have a follow up question. For the raise guides, can you talk more about the drivers and what you're seeing from new patient starts and hospital restarts trends in the initial four weeks in 3Q and learning some prior summer months that informs your commercial outlook for 2025?

大家好，我是 Maury 的 James。恭喜您的進展，並感謝您回答我們的問題。關於 LUPKYNIS 的另一個問題，我有一個後續問題。對於加薪指南，您能否詳細談談驅動因素以及您從第三季度最初四周的新患者開始和醫院重啟趨勢中看到的情況，並了解一些前夏季月份的情況，以了解您對 2025 年的商業展望？

Yeah, I want to start. And Joe, if I miss anything, please jump in. So I think the best way to think about our guidance range is, on the lower end to the midpoint of our revised guidance, you'd have to see either a flattening of our business or a declining of our business in the summer months and back to growth in the back half of the year. The higher end of our guidance range is continued growth through Q3 and 4Q.

是的，我想開始。喬，如果我遺漏了什麼，請告訴我。因此，我認為思考我們的指導範圍的最佳方式是，在我們修訂後的指導的下限到中點，您必須看到我們的業務在夏季趨於平穩或下滑，然後在下半年恢復增長。我們的指導範圍的高端是第三季和第四季的持續成長。

If you look historically, James, at how our sales have progressed and as we've said on previous calls, we now think history is probably the best way to predict how this business moves forward.

詹姆斯，如果你回顧歷史，看看我們的銷售是如何發展的，正如我們在之前的電話會議上所說的那樣，我們現在認為歷史可能是預測這項業務如何發展的最佳方式。

The summer months have, we've seen a slowing in some of our metrics, in particular, the PSFs have been a little lighter, historically in the summer months, and our revenue has been relatively flat to the previous quarter, so flat to 2Q using history, so the way we're looking at our guidance range is the low to mid. You see the historical trends, the high to high to beat above is, we keep growing quarter on quarter, and we're really encouraged by everything we're seeing in the business right now. So, we're excited to take up the guidance range and that's kind of how we're thinking about it, James.

夏季，我們發現一些指標有所放緩，特別是 PSF 在過去夏季月份有所下降，而我們的收入與上一季度相比相對持平，因此與第二季度持平，因此我們看待指導範圍的方式是低到中等。您可以看到歷史趨勢，上面的高點到高點是，我們保持逐季成長，我們對目前業務中看到的一切都感到鼓舞。因此，我們很高興能夠接受指導範圍，這就是我們的想法，詹姆斯。

Got it, thanks. And then the second one for your BAFF APRIL inhibitor, aritinercept, can you talk more about when we can see the next data update from the MAD phase, and more on rare/orphan autoimmune diseases that you aim to pursue, what are the gating factors to picking specific disease settings to pursue? Are you waiting for competitor updates or is it more related to evolving internal strategy?

明白了，謝謝。然後第二個問題是關於您的 BAFF APRIL 抑制劑阿替西普，您能否詳細談談我們何時可以看到 MAD 階段的下一次數據更新，以及更多關於您想要研究的罕見/孤兒自身免疫性疾病的信息，選擇要研究的特定疾病環境的限制因素是什麼？您是在等待競爭對手的更新還是與不斷發展的內部策略更相關？

Well, I mean, I wouldn't assume that we were waiting and I wouldn't assume that we're ruminating on any of this. I would say I would assume we're moving forward. We're just not communicating externally for public reasons exactly what our approach is going to be or the timing of those programs.

嗯，我的意思是，我不會認為我們在等待，也不會認為我們在思考這些事情。我想說，我認為我們正在向前邁進。基於公開原因，我們不會對外透露我們的具體做法或這些計劃的具體時間。

As we've said, we want to go after at least two B cell mediated diseases. We were going to get those enrolling by this year -- by the end of this year, and we'll look forward in the future to talking more about it, but at this stage, that's all we're giving, James.

正如我們所說，我們想要研究至少兩種 B 細胞介導的疾病。我們原本計劃在今年年底前讓這些學生入學，我們期待在未來討論更多相關事宜，但目前，我們只能透露這些，詹姆斯。

Got it. Thanks for taking our questions. I'll hop back in the queue.

知道了。感謝您回答我們的問題。我會重新回到隊列中。

Joseph Schwartz, Leerink Partners.

Leerink Partners 的 Joseph Schwartz。

Hey guys, this is Will on for Joe. Thanks for taking our questions today and congrats on the progress this quarter. So, I just have one on the B cell program and then a quick follow up. So, on the prior data call you had mentioned that you were doing some formulation work for AUR200. Is this work still ongoing or is it going to be completed prior to the initiation of these future studies later this year? And can you just help us understand the point of this formulation work? Is it specifically to do an auto injector or what's the ultimate goal here? And I have a quick follow-up. Thanks.

大家好，我是威爾，請接聽喬的電話。感謝您今天回答我們的問題，並祝賀您本季的進展。因此，我只對 B 細胞程序進行了一次快速跟進。因此，在先前的數據通話中您提到您正在為 AUR200 做一些制定工作。這項工作是否仍在進行中，還是將在今年稍後開始這些未來研究之前完成？您能幫助我們理解這個配方工作的要點嗎？它是專門用來做自動注射器的嗎？或者它的最終目標是什麼？我有一個快速的後續行動。謝謝。

Yeah, as we said on our previous call, well, our goal would be to try to get it in the most patient friendly potential formulation and device possible, and that could include an auto injector. And we actually think looking at the doses we've seen to date, the molecular size that that we have -- we could have the possibility to do that.

是的，正如我們在上次電話會議上所說的那樣，我們的目標是嘗試以最適合患者的潛在配方和設備來實現它，其中可能包括自動注射器。我們實際上認為，從我們迄今為止所看到的劑量和分子大小來看，我們有可能做到這一點。

But obviously, once you're in single ascending dose studies, you're not optimized towards, well at least we haven't to those formulations yet. And that's -- it's parallel pathing with the development work that we're doing, but everything points to us being able to, from what we've seen in the single ascending dose and in the preclinical work we've done up to this point, that those goals would be attainable.

但顯然，一旦你進入單次遞增劑量研究，你就沒有針對這些配方進行優化，至少我們還沒有針對這些配方進行優化。那是 — — 它與我們正在進行的開發工作是平行的，但一切都表明，從我們在單次遞增劑量和迄今為止所做的臨床前工作中看到的情況來看，這些目標是可以實現的。

Great, thank you. And then just quickly a question for Joe as we see the development of AUR200 ramp up, how should we be thinking about R&D spend moving forward? And can you help us put some brackets or kind of general commentary around the cost for these trials? And do you expect to remain cash flow positive during the development of this asset? Thank you.

太好了，謝謝。然後，我想快速問喬一個問題，隨著 AUR200 的開發不斷推進，我們該如何考慮未來的研發支出？您能否幫助我們對這些試驗的成本進行一些概括或一般性的評論？您是否預計在開發該資產期間保持正現金流？謝謝。

Thanks for the question, Will. We haven't provided any specific guidance on operating expenses and/or cash flows going forward. Obviously, as we're moving through 2025, the trial costs were fairly manageable, and you would expect as you kind of move from Phase 1 into 2 and on that the costs will increase. But as of right now, we're not getting any specific long-term guidance on OpEx, R&D expenses, and/or cash flows.

謝謝你的提問，威爾。我們尚未對未來的營運費用和/或現金流提供任何具體指導。顯然，隨著我們進入 2025 年，試驗成本是相當可控的，您可以預料到，隨著從第 1 階段進入第 2 階段，成本會增加。但截至目前，我們還沒有得到任何關於營運支出、研發費用和/或現金流的具體的長期指導。

Yeah, I think that's right, Joe, and the only thing I would say is it should be evident to investors that efficient operations and cash flow from operations however we decide to deploy it is in a priority for us as an organization so that won't change on a go forward basis.

是的，喬，我認為這是對的，我唯一想說的是，投資者應該清楚，無論我們決定如何部署，高效的營運和營運現金流都是我們作為一個組織的優先事項，因此這在未來不會改變。

Great. Thanks for the color and congrats again.

偉大的。謝謝你的顏色，再次恭喜。

Thanks, Will

謝謝，威爾

Arthur He, HC Wainwright.

亞瑟·何，HC·溫賴特。

Hey, good morning, guys. Congrats on the [Q2 race]. I just got the two questions regarding the 200. So, Greg, do you guys plan to present the detailed data at any medical conference from the SAD study?

嘿，大家早安。恭喜[Q2比賽]我剛剛收到有關 200 的兩個問題。那麼，格雷格，你們計劃在任何醫學會議上展示 SAD 研究的詳細數據嗎？

I mean, Greg maybe can talk to what our intentions are. I think you should just appreciate that obviously we have ongoing patent work, et cetera, with the compound. So what's publicly detailed we would have that ability to do, but stuff that has not yet been publicly talked about, probably not. Greg, any intentions?

我的意思是，格雷格或許可以談談我們的意圖。我認為您應該明白，我們顯然正在對該化合物進行專利工作等等。因此，對於已公開詳細說明的內容，我們有能力去做，但對於尚未公開談論的內容，可能就沒能力去做。格雷格，有什麼意圖嗎？

No, nothing more than that they will be presented in an upcoming meeting, but we haven't determined which meeting at this point.

不，只不過它們將在即將召開的會議上提出，但目前我們還沒有確定是哪次會議。

Okay. Got you. And the second question on the 200. So maybe, Peter, I just want to gauge like at what kind of situation or circumstance you guys would feel comfortable to disclose the information about the details of indication going after for the 200. Just curious.

好的。明白了。第二個問題是關於 200 的。所以，彼得，也許我只是想判斷一下，在什麼樣的情況或環境下，你們會願意披露有關 200 的指示細節的資訊。只是好奇。

Well, I mean, the obvious answer is when we move into a certain phase of development, it becomes public information and available on clinicaltrials.gov. So that would be my absolute answer. We haven't really discussed it with our Board, Arthur. We have, and we've deduced, concluded that for competitive purposes, obviously, we've got people that are ahead of us and behind us and we want to hold what we're doing close to the vest and ensure that we don't lead people down the path of exactly what we're doing.

嗯，我的意思是，顯而易見的答案是，當我們進入某個開發階段時，它就會成為公共訊息，並在clinicaltrials.gov上公佈。所以，我的答案絕對是這樣的。我們還沒有真正與董事會討論過這個問題，亞瑟。我們已經推斷出，出於競爭的目的，顯然，我們有一些領先於我們和落後於我們的人，我們希望對自己所做的事情保密，確保我們不會引導別人走上我們正在做的事情的道路。

We haven't determined yet when we would disclose but do realize from the line of questioning here and on our previous call that there's a lot of appetite to understand what our plans are.

我們尚未確定何時披露，但從這裡的提問和我們之前的電話會議中我們意識到，很多人都想了解我們的計劃。

Doug Miehm, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Doug Miehm。

Yeah, good morning, Peter, Joe. Just with respect to paragraph 4, filers, there's no change there, no changes stands right now in terms of the exclusivity period and adding pediatric onto that, any updates?

是的，早安，彼得，喬。關於第4段，申請人，目前沒有變化，在獨佔期和添加兒科方面沒有任何變化，有什麼更新嗎？

No, and just to clarify that the pediatric trial work that we're doing was part of the original filing but was not an extension body of work, so the July 2028 worst case scenario is not inclusive of six months of pediatric exclusivity, Doug. No changes. We still have patents going all the way out to 2037.

不，只是為了澄清一下，我們正在進行的兒科試驗工作是原始申請的一部分，但不是延伸工作，因此 2028 年 7 月的最壞情況不包括六個月的兒科獨佔期，道格。沒有變化。我們的專利有效期到 2037 年仍然有效。

We still have our method of use patents, and we continue to do more work around both patents and other work in the company to ensure the longevity of LUPKYNIS. I would just reinforce that the longevity of this asset to us is paramount, and it comes to defending the IP that we have around the compound and it's a priority for the company. So we'll update you when we have more to talk about but as the legal process on and filings and the subsequent patent infringement lawsuits is pretty protracted, so I wouldn't expect to hear weekly updates from us.

我們仍然擁有使用方法專利，我們將繼續圍繞專利和公司的其他工作進行更多工作，以確保 LUPKYNIS 的長久發展。我只想強調，對我們來說，這項資產的長久性至關重要，這涉及到保護我們圍繞大院的智慧財產權，這是公司的首要任務。因此，當我們有更多消息要談時，我們會向您通報最新情況，但由於法律程序和申請以及隨後的專利侵權訴訟相當漫長，所以我預計不會每週收到我們的更新消息。

No, okay. Second question just has to do with the buyback, and you're aggressive there. There's an obvious opportunity today as we think about the future though, given the amount that you're likely to spend on the R&D side, and it's going to increase probably fairly materially. We think that we could see scaled back buybacks as we think about beyond 2025. I'll leave it there.

不，好吧。第二個問題與回購有關，您在這方面表現得很積極。然而，當我們思考未來時，今天就有一個明顯的機會，考慮到你可能在研發方面投入的金額，而且它可能會大幅增加。我們認為，展望 2025 年以後，回購規模可能會縮減。我就把它留在那裡。

Doug, as we've said, it's up to the Board's discretion and as to how they deploy that cash. Obviously, management gives input to our belief as to what we should do. I wouldn't miss that LUPKYNIS continues to grow for us, and the cash flows we reported in this quarter, if you carry that forward and you carry forward continued growth of LUPKYNIS, the amount of cash flow from operations becomes fairly significant.

道格，正如我們所說，這取決於董事會的判斷以及他們如何部署這筆現金。顯然，管理層對我們應該做什麼的信念提供了意見。我不會錯過 LUPKYNIS 為我們帶來的持續成長，以及我們在本季度報告的現金流，如果你將其延續下去並延續 LUPKYNIS 的持續成長，那麼來自經營的現金流量將變得相當可觀。

Now we're not giving long term or even mid to short term guidance on cash flows, but you can do the math, and I think it gives us a very unique position as a biotech company in this space to pay our bills. We have cash on our balance sheet. We have cash flows from operations, so we can pay for the things we want to do, continuing to drive LUPKYNIS and developing our pipeline, and we have the unique ability to either collect cash -- more cash on our balance sheet and grow that over time or deploy it towards buying back shares, which is positive for all shareholders.

現在，我們沒有給出長期甚至中短期的現金流指導，但你可以算一下，我認為這讓我們作為一家生物技術公司在這個領域擁有非常獨特的地位來支付我們的賬單。我們的資產負債表上有現金。我們有來自營運的現金流，因此我們可以支付我們想要做的事情，繼續推動 LUPKYNIS 和開發我們的管道，並且我們擁有獨特的能力，可以收集現金 - 在我們的資產負債表上增加更多現金並隨著時間的推移增加現金，或者將其用於回購股票，這對所有股東都是有利的。

So while we're not giving anything for 2026, and I don't disagree that obviously your R&D expenses go up as you move into further clinical trials, don't miss the fact that, if LUPKYNIS, which we fully believe will continue to grow, grows, our cash flow from operations and our balance sheet are still very, very strong.

因此，雖然我們沒有為 2026 年做出任何貢獻，而且我也不否認，隨著你們進入進一步的臨床試驗，你們的研發費用顯然會增加，但不要忽視這樣一個事實：如果 LUPKYNIS（我們完全相信它會繼續增長）繼續增長，我們的營運現金流和資產負債表仍然非常非常強勁。

Great. Thank you.

偉大的。謝謝。

Thank you. And this concludes -- we have reached the end of the question-and-answer session, and this also concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation and have a great day.

謝謝。到此為止——我們的問答環節已經結束，今天的會議也結束了，大家可以掛斷電話了。感謝您的參與並祝您有個愉快的一天。