Aurinia Pharmaceuticals Inc (AUPH) 2024 Q4 法說會逐字稿

Greetings and welcome to the Aurinia Pharmaceuticals fourth quarter and full year 2024 earnings call.

問候並歡迎參加 Aurinia Pharmaceuticals 2024 年第四季和全年收益電話會議。

(Operator Instructions)

（操作員指令）

I would now like to turn the conference over to your host, Andrea Christopher, Head of Corporate Communication and Investor Relations for Aurinia. Thank you. You may begin.

現在，我想將會議交給主持人、Aurinia 企業傳播和投資者關係主管 Andrea Christopher。謝謝。你可以開始了。

Thank you, operator, and thank you to everyone for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's 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 和 Aurinia 首席醫療官 Greg Keenan 博士。

Today we will review and discuss Aurinia's fourth quarter and full year 2024 financial results and provide an update on recent corporate progress, as communicated in the company's press release and annual report on Form 10k issued this morning.

今天，我們將回顧和討論 Aurinia 2024 年第四季度和全年的財務業績，並提供最近的公司進展更新，正如公司今天上午發布的新聞稿和 10k 表年度報告中所述。

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.

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，該文件也可在 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.

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。

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

有關可能影響 Aurinia 未來財務表現和業務的因素的討論，請參閱 Aurinia 的新聞稿、10k 表年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, February 27, 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 statements. Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter.

請注意，除非另有說明，今天電話會議中所作的所有聲明均為截至 2025 年 2 月 27 日的最新聲明，並且基於我們目前掌握的資訊。除法律要求外，Aurinia 不承擔更新任何此類聲明的義務。現在，讓我將電話轉給 Aurinia 總裁兼執行長 Peter Greenleaf。彼得。

Thanks, Andrea, and good morning, everyone. I want to thank you all for joining us on today's call. On this morning's call, I'll provide an update on our fourth quarter and full year 2024 results and provide an update on our 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。我要感謝大家參加今天的電話會議。在今天上午的電話會議上，我將介紹我們第四季和 2024 年全年的業績以及我們最近的進展。然後，我將把電話轉給我們的財務長喬·米勒，以提供有關我們財務業績的更多詳細資訊。

With the continued focus on commercial execution and operational efficiency, we achieved significant growth in total revenue and record setting net product sales in the fourth quarter of 2024.

透過持續專注於商業執行和營運效率，我們在 2024 年第四季實現了總收入的顯著成長和創紀錄的淨產品銷售額。

For the fourth quarter of 2024, total revenue was $59.9 million up 33% from $45.1 million in the same period of 2023. For the full year 2024, total revenue was $235.1 million up 34% from $175.5 million in 2023.

2024 年第四季總營收為 5,990 萬美元，較 2023 年同期的 4,510 萬美元成長 33%。2024 年全年總營收為 2.351 億美元，較 2023 年的 1.755 億美元成長 34%。

For the fourth quarter of 2024, net product sales of LUPKYNIS, the first FDA approved oral therapy for the treatment of adult patients with active LN, were $57.6 million up 36%, compared to $42.3 million in the same period of 2023. For the full year of 2024, net product sales were $216.2 million up 36% from $158.5 million in 2023.

2024 年第四季度，FDA 核准的首個用於治療活動性狼瘡性腎炎成人患者的口服療法 LUPKYNIS 的淨產品銷售額為 5,760 萬美元，較 2023 年同期的 4,230 萬美元增長 36%。2024 年全年淨產品銷售額為 2.162 億美元，較 2023 年的 1.585 億美元成長 36%。

The increase in both periods is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies driven by further LN market penetration.

兩個時期的成長主要是由於 LN 市場進一步滲透導致銷售給專業藥局的 LUPKYNIS 紙盒數量增加。

For three months ended December 31, 2024. Cash flow generated from operations was $30.1 million compared to $14.3 million in the same period of 2023. The year ended December 31, 2024. Cash flow generated from operations was $44.4 million compared to cash flow used in operations of $33.5 million in 2023.

截至 2024 年 12 月 31 日的三個月。經營活動產生的現金流量為 3,010 萬美元，而 2023 年同期為 1,430 萬美元。截至 2024 年 12 月 31 日的年度。經營活動產生的現金流為 4,440 萬美元，而 2023 年經營活動所用現金流為 3,350 萬美元。

Following last year's strategic restructuring, we are pleased with how our cash flow improved throughout 2024. Exiting the year, we have cash equivalents, restricted cash and investments of $358.5 million as of December 31, 2024.

繼去年的策略重組之後，我們對 2024 年全年現金流的改善感到滿意。截至 2024 年 12 月 31 日，我們的現金等價物、受限現金和投資為 3.585 億美元。

As we are now into our fifth year on the market, we believe that our historical financial results provide sufficient insight into the health of our business to project forward-looking results. Therefore, we're not providing specific patient level metrics. With our strong 36% sales growth for LUPKYNIS in 2024, we are poised for continued success and have a commercial strategy that is focused on four key growth drivers.

由於我們現在已經進入市場第五年，我們相信我們的歷史財務表現足以洞察我們業務的健康狀況，從而預測前瞻性的業績。因此，我們不提供具體的患者層級指標。憑藉 2024 年 LUPKYNIS 強勁的 36% 的銷售額成長，我們準備繼續取得成功，並制定了專注於四大關鍵成長動力的商業策略。

First, we've sharpened our focus on expanding our base of business at academic medical centres and lupus centres. We've also targeted key rheumatology prescriber segments and identified key lupus nephritis patient types.

首先，我們更加重視擴大學術醫療中心和狼瘡中心的業務基礎。我們也針對了風濕病學處方的關鍵群體，並確定了狼瘡性腎炎的關鍵患者類型。

This would include newly diagnosed patients. Patients who are only on MMF and steroids, patients receiving treatment but not achieving treatment potential targets and potential for LUPKYNIS restarts.

其中包括新診斷的患者。僅使用 MMF 和類固醇的患者、接受治療但未達到治療潛在目標的患者以及有可能重新開始使用 LUPKYNIS 的患者。

Second, we expect the new ACR lupus nephritis treatment guidelines to help drive positive momentum for LUPKYNIS this year, and we're continuing to create a treat to target mindset among rheumatologists that drives the overall treatment urgency to screen and treat lupus nephritis more aggressively.

其次，我們預計新的 ACR 狼瘡性腎炎治療指南將有助於推動今年 LUPKYNIS 的積極發展勢頭，並且我們將繼續在風濕病學家中創造一種以治療為目標的思維模式，以推動整體治療的緊迫性，以更積極地篩檢和治療狼瘡性腎炎。

Third, we continue to reinforce the impressive three-year efficacy data and safety data from our Aurora clinical program to clinically differentiate LUPKYNIS and position it earlier in the treatment paradigm.

第三，我們繼續強化 Aurora 臨床計畫令人印象深刻的三年療效數據和安全性數據，以在臨床上區分 LUPKYNIS，並將其定位在治療範例的早期階段。

And lastly, we're focused on improving continuity of care for lupus nephritis patients by growing our hospital business and keeping patients on therapy for longer periods of time.

最後，我們致力於透過發展醫院業務和讓患者接受更長時間的治療來改善狼瘡性腎炎患者的護理連續性。

We're very pleased to start 2025 in a solid position with a highly efficient organization focused on LUPKYNIS growth and therefore expect total revenue for 2025 in the range of $250 million to $260 million and net product sales in the range of $240 million to $250 million for 2025.

我們非常高興能夠在 2025 年以穩固的地位開啟新的一年，我們擁有一個專注於 LUPKYNIS 成長的高效組織，因此預計 2025 年的總收入將在 2.5 億至 2.6 億美元之間，淨產品銷售額將在 2.4 億至 2.5 億美元之間。

Finally, we are also continuing to advance the development of our pipeline product, AUR200, a potentially best in class dual BAFF and APRIL inhibitor for the potential treatment of a range of autoimmune diseases.

最後，我們也持續推動我們的管道產品 AUR200 的開發，該產品是一種潛在的同類最佳的雙重 BAFF 和 APRIL 抑制劑，可用於治療一系列自體免疫疾病。

We initiated a phase one study last September and expect to report our initial results from this study in the second quarter of 2025.

我們於去年 9 月啟動了第一階段研究，預計將在 2025 年第二季報告該研究的初步結果。

I'd now like to turn the call over to Joe Miller, our CFO, for more detailed review of the fourth quarter and full year financial results. I'll then return to end the call for a quick wrap up and 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，以更詳細地審查第四季度和全年財務業績。然後我將回來結束通話，快速總結一下，並回答您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 fourth quarter and full year 2024 financial results. For the three months end of December 31, 2024, total revenue was $59.9 million compared to $45.1 million for the same period of 2023. For the year ending December 31, 2024, total revenue was $235.1 million compared to $175.5 million in 2023.

謝謝你，彼得，大家早安。讓我們花幾分鐘討論一下 2024 年第四季和全年的財務表現。截至 2024 年 12 月 31 日的三個月，總收入為 5,990 萬美元，而 2023 年同期為 4,510 萬美元。截至 2024 年 12 月 31 日的年度，總收入為 2.351 億美元，而 2023 年為 1.755 億美元。

As Peter mentioned, we had cash, cash-equivalents, restricted cash, and investments of $358.5 million as of December 31, 2024, and generated cash flows from operations of $44.4 million. 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.

正如彼得所提到的，截至 2024 年 12 月 31 日，我們的現金、現金等價物、受限現金和投資為 3.585 億美元，經營活動產生的現金流為 4,440 萬美元。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裁量股票回購提供資金。

As of February 25, 2025, the company has repurchased approximately $9.7 million of its common shares for approximately $70 million since the launch of the program in the first quarter of 2024.

截至 2025 年 2 月 25 日，自 2024 年第一季啟動該計畫以來，該公司已以約 7,000 萬美元的價格回購了約 970 萬美元的普通股。

For the three months ended December 31, 2024, cost of revenue was $5.6 million compared to $5.4 million in the same period of 2023.

截至 2024 年 12 月 31 日的三個月，收入成本為 560 萬美元，而 2023 年同期為 540 萬美元。

For the year ended December 31, 2024, cost of revenue was $28.2 million compared to $14.1 million in 2023. The increase for the full year is primarily due to the amortization of the finance rate of use lease asset recognizing connection with the monoplant, which was placed into service in late 2023 and therefore only partially impacted by prior year cost of revenue.

截至 2024 年 12 月 31 日止年度，收入成本為 2,820 萬美元，而 2023 年為 1,410 萬美元。全年成長主要歸因於與單一工廠相關的使用租賃資產確認的融資率攤銷，該工廠於 2023 年底投入使用，因此僅部分受到上一年收入成本的影響。

With the three months ended December 31, 2024. Gross margin was 91% compared to 88% in the same period of 2023. For the year end of December 31, 2024, gross margin was 88% compared to 92% in 2023.

截至 2024 年 12 月 31 日的三個月。毛利率為 91%，而 2023 年同期為 88%。截至 2024 年 12 月 31 日的年度毛利率為 88%，而 2023 年為 92%。

For the three months ended December 31, 2024, total operating expenses were $61.5 million compared to $74.8 million in the same period of 2023. For the year ended December 31, 2024, total operating expenses were $239.8 million compared to $267.2 million in 2023.

截至 2024 年 12 月 31 日的三個月，總營運費用為 6,150 萬美元，而 2023 年同期為 7,480 萬美元。截至 2024 年 12 月 31 日止年度，總營運費用為 2.398 億美元，而 2023 年為 2.672 億美元。

The decrease in both prairies is primarily due to lower personnel costs, 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.

兩種草原的減少主要是由於我們在 2024 年的策略重組努力導致人員成本降低（包括股權激勵和管理費用），再加上由於停止公司 AUR300 開發計劃導致非人員研發費用減少。

These savings in both periods are partially offset by a one-time termination benefit, contract terminations, and other costs associated with our strategic restructuring efforts undertaken throughout 2024.

這兩個期間的節省部分被一次性終止福利、合約終止以及與我們 2024 年全年進行的策略重組工作相關的其他成本所抵消。

For the three months ended December 31, 2024, net income was $1.4 million or $0.01 of earnings per share compared to net loss of $26.9 million or $0.19 of net loss per share in the same period of 2023. For the year end of December 31, 2024, net income was $5.8 million or $0.04 of earnings per share compared to a net loss of $78 million or $0.54 of net loss per share in 2023.

截至 2024 年 12 月 31 日的三個月，淨收入為 140 萬美元，即每股收益 0.01 美元，而 2023 年同期的淨虧損為 2,690 萬美元，即每股淨虧損 0.19 美元。截至 2024 年 12 月 31 日的年度，淨收入為 580 萬美元，即每股收益 0.04 美元，而 2023 年的淨虧損為 7,800 萬美元，即每股淨虧損 0.54 美元。

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

最後，我想將電話轉回給彼得，請他做一些結束語。彼得。

Thanks, Joe. In summary, implementing a highly focused industry leading operational strategy has allowed us to lean further into the highest growth drivers for the commercial LUPKYNIS business, accelerate clinical development of AUR200, and further strengthen our balance sheet.

謝謝，喬。總之，實施高度集中的行業領先營運策略，使我們能夠進一步傾向於商業 LUPKYNIS 業務的最高成長動力，加速 AUR200 的臨床開發，並進一步加強我們的資產負債表。

We now have more flexibility to engage in activities that can strategically enhance our business. I want to thank you all for your time today. We'll now open the lines for any questions, operator.

我們現在可以更靈活地參與能夠從策略上增強我們業務的活動。我感謝大家今天抽出時間。接線員，我們現在將開通熱線來回答任何問題。

(Operator Instructions)

（操作員指令）

Stacy Ku, TD Cowen.

史黛西·庫（Stacy Ku），TD Cowen 公司。

Hi, good morning. This is Vish on for Stacy, and, congrats on the year and thanks so much for taking our questions. We had a couple, so, thanks for talking about your kind of, growth, key growth drivers and so as we think about those in about 2025.

嗨，早安。我是 Vish，代表 Stacy，恭喜你們這一年，非常感謝你們回答我們的問題。我們有幾個，所以，感謝您談論您的成長、關鍵成長動力，以及我們對 2025 年左右的成長動力的思考。

Can you give us some more details around with the current sales force, how you are maximizing the opportunity for kindness, especially given the addition to the ACR guidelines, maybe some more details on these prescriber segments and then the second question is probably on the AUR200 asset, so we're really, looking forward to the Q2 read out.

您能否向我們提供有關當前銷售團隊的更多詳細信息，您如何最大限度地利用善意的機會，特別是考慮到 ACR 指南的補充，也許還有一些關於這些處方者細分的詳細信息，然後第二個問題可能是關於 AUR200 資產，所以我們真的很期待第二季度的業績。

Can you remind us what sort of data we can expect and what we'll be able to kind of clean or infer from it? Thank you very much.

您能否提醒我們，我們可以期待什麼樣的數據，以及我們可以從中清理或推斷出什麼？非常感謝。

Vish thank you for the questions. Let me start with the first, and then I might ask Greg to jump in if I miss anything on the second. Your first question on your sort of post our restructuring, maximizing the opportunity as it relates to LUPKYNIS as we went through in the call, I think we've got four key areas we're focused on, and let me try to at least to relate two of those to how we address them post the restructuring.

非常感謝您的提問。讓我先從第一點開始，然後如果我遺漏了第二點中的任何內容，我可能會請 Greg 來補充。您第一個問題是關於我們的重組後，如何最大限度地利用與 LUPKYNIS 相關的機會，正如我們在電話會議中所討論的那樣，我認為我們有四個重點關注的關鍵領域，讓我嘗試至少將其中兩個與我們在重組後如何解決這些問題聯繫起來。

The first is a strong focus on rheumatology, as we all know, LN patients or SLE patients that progress to worsening outcomes, and they present, well, they present probably originally at a primary care physician's office, but once diagnosed, they're with the rheumatologist and if our goal is to drive the ACR guidelines and what they propose should be the treatment of the disease and the diagnosis of the disease.

首先是重點關注風濕病學，眾所周知，狼瘡性腎炎 (LN) 患者或系統性紅斑狼瘡 (SLE) 患者的病情會逐漸惡化，他們最初可能在初級保健醫生的辦公室就診，但一旦確診，他們就會去找風濕病專家，如果我們的目標是推動 ACR 指南，那麼他們提出的建議應該是疾病的治療和疾病的診斷。

Initial diagnosis and initial treatment really should happen aggressively within the rheumatologist's office. So, as we restructured our group, one of the things we put a very high priority on was focusing on high prescribing SLE and LN offices which we would pick up from, both codes through actually looking at patient, not actual patient, but patient charts that we're able to look at in a blinded fashion.

初步診斷和初步治療應該在風濕病科醫生的辦公室內積極進行。因此，在我們重組團隊時，我們高度重視的事情之一就是關注處方量很大的 SLE 和 LN 診所，我們將透過實際查看患者（不是實際患者）而是以盲法查看患者圖表來獲取這兩種代碼。

So, the high prescribing rheumatology office is one area hugely important. The guidelines you mentioned in your question, hugely important since we know that there's an underdiagnosis and an undertreatment of the disease.

因此，高處方風濕病辦公室是一個非常重要的區域。您在問題中提到的指導方針非常重要，因為我們知道這種疾病有診斷不足和治療不足的情況。

And then lastly, we've focused our resources again against the hospital segment because we know that major medical centres around the country that have lupus centres that are lupus centres and have lupus clinics are critically important to capturing patients early in their diagnosis if they have elevated proteinuria.

最後，我們再次將資源集中在醫院領域，因為我們知道全國各地設有狼瘡中心和狼瘡診所的大型醫療中心對於在患者蛋白尿升高時儘早診斷至關重要。

So, there are just a few examples of how we've not just tightened our resources but focused them down against two segments that we think are critically important.

因此，這裡僅舉幾個例子來說明我們不僅收緊資源，而且將其集中在我們認為至關重要的兩個領域。

On your second question, which focuses on AUR200, as you heard on the call, we're looking forward to disclosing what we see from our single ascending dose trial that's ongoing, and we'll be out at the end of Q2 this year. I think what you can expect to see are normal pharmacodynamics and normal pharmacokinetic data.

關於您的第二個問題，重點關注 AUR200，正如您在電話會議上聽到的那樣，我們期待著披露我們正在進行的單次遞增劑量試驗的結果，我們將在今年第二季度末公佈結果。我認為您可以看到的是正常的藥效學和正常的藥物動力學數據。

Obviously in the APRIL, BAFF space there are some important markers such as IGG, IGA, IGM that we would hope to be able to show as well. This data is going to be critically important in understanding what dose we take into the MAD study and what structure we actually use in that study as we progress out of the SAD and into the MAD. I don't think I missed anything there, did I, Greg?

顯然，在 APRIL、BAFF 領域有一些重要的標記，例如 IGG、IGA、IGM，我們也希望能夠展示這些標記。當我們從 SAD 進入 MAD 時，這些數據對於了解我們在 MAD 研究中採取的劑量以及我們在該研究中實際使用的結構至關重要。我認為我沒有錯過任何東西，是嗎，格雷格？

Thank you. Next question.

謝謝。下一個問題。

Olivia Brayer, Cantor Fitzgerald.

奧莉維亞·布雷爾，費茲傑拉領唱者。

Hi, good morning, thank you for the questions. How are you all thinking about LUPKYNIS growth beyond 2025? It looks like you're getting to about 13% this year at the midpoint. So, is low double digits the right way to think about growth rate these next few years?

大家好，早安，感謝您的提問。你們如何看待 2025 年後 LUPKYNIS 的成長？看起來今年的中間值將達到 13% 左右。那麼，低兩位數是考慮未來幾年成長率的正確方式嗎？

And then on AUR200, will you guys actually be disclosing the dose for the MAD portion and indication selection in that second quarter update? And is there anything you can tell us at this point about Half-Life and potential dose frequency for your candidate? Thank you, guys.

然後在 AUR200 上，你們是否會在第二季更新中揭露 MAD 部分的劑量和適應症選擇？現在您能告訴我們有關候選人的半衰期和潛在劑量頻率的任何資訊嗎？謝謝你們。

Thanks, Olivia. So, we haven't historically and don't intend to today give long term guidance on the LUPKYNIS, but you can see what we've sort of cantered our metrics upon, and it's, listen, this product's been on the on the market now for four going into its fifth year, and we think those historical trends are the best way to think about on the product on a go forward basis, so hopefully that's helpful.

謝謝，奧莉維亞。因此，從歷史上看，我們並沒有、今天也不打算對 LUPKYNIS 給予長期指導，但你可以看到，我們的指標就是以此為基礎的，聽著，這款產品已經上市四年，即將進入第五年，我們認為這些歷史趨勢是展望未來產品的最佳方式，所以希望這對大家有所幫助。

On AUR200 and the SAD data, I will just hold back on saying what we will or won't disclose because we actually have to see the data first. I think as we move into the MAD study, it would probably be good and there would probably be an expectation out there that will give some steer as to how we're going to conduct the MAD.

關於 AUR200 和 SAD 數據，我不會透露我們願意披露或不願意披露的內容，因為我們實際上必須先看到數據。我認為，隨著我們進入 MAD 研究，結果可能會很好，而且外界可能會有所期待，這將為我們如何進行 MAD 提供一些指導。

But I guess I would just ask that we get the SAD data first, see what it shows us. I think it'll be really strong context for what we think we have in this versus others that are also doing development in the space. And then the next natural question is, well, how does that inform the MAD study which we're just a few months away from, so look forward to having that conversation.

但我想我只是想先取得 SAD 數據，看看它向我們展示了什麼。我認為，這將為我們在這一領域取得的成就以及其他在該領域進行開發的公司提供強有力的支持。那麼下一個自然的問題是，這對我們僅剩幾個月時間的 MAD 研究有何啟示，所以我們期待著這場對話。

Okay, understood. Thanks, Peter. Well, what about in terms of timelines for, obviously I know we have to see the SAD data first, but in terms of next steps and timelines for that MAD portion of the study, can you guys put any kind of numbers or timelines around that?

好的，明白了。謝謝，彼得。那麼，就時間表而言，顯然我知道我們必須先看到 SAD 數據，但就研究中 MAD 部分的後續步驟和時間表而言，你們能否給出任何數字或時間表？

Yeah, I guess I would go back to what I just said. Let us get the SAD data first, and then we'll tell you what we intend to do in the MAD and that'll inform how long MAD's going to take and what our what our projections are to completion of that. So, more to come.

是的，我想我會回到我剛才說過的話。讓我們先取得 SAD 數據，然後我們會告訴您我們打算在 MAD 中做什麼，並告知 MAD 需要多長時間以及我們對完成的預測是什麼。因此，接下來還會有更多。

Okay, understood looking forward to it thank you guys.

好的，明白了，期待大家的幫忙。

Thanks, Olivia.

謝謝，奧莉維亞。

[Farzen Hay], Jeffreys.

[Farzen Hay]，傑弗里斯。

Hi, this is Amin on for Maury. Thank you for taking our questions. Two from us. One on the guidance just following up with the previous question, you issued the guidance of 250, 240 to 250, and it seems to be somewhat conservative given the 4Q run rate. What are you seeing in initial two months of this year that informs you the commercial outlook for 2025 and then on exclusivity.

大家好，我是 Maury 的 Amin。感謝您回答我們的問題。我們有兩個。關於指引，緊接著上一個問題，您發布了 250、240 到 250 的指引，考慮到第四季度的運行率，這個指引似乎有些保守。今年前兩個月看到了什麼，可以告訴您 2025 年的商業前景以及獨家性。

LUPKYNIS has orange exclusivity protection until January 26, if I'm not mistaken, and as expected, an NDA was filed by [lotus] earlier this month. Maybe talk about your strategy there and is the base case assumption is still that the earliest generic can come to market in first half 28.

如果我沒記錯的話，LUPKYNIS 擁有橙色獨家保護，有效期至 1 月 26 日，而且正如預期的那樣，[lotus] 已於本月初提交了一份保密協議 (NDA)。也許可以談談您的策略，基本假設仍然是最早的仿製藥可以在 28 年上半年上市。

Yeah, let me start on the first question, which was our guidance range and what have we seen early in the year. I think our guidance range is. As we said on the call, very much driven by what we know now after being in our fifth year on the market and looking very closely at our historical financial results and using that to sort of project out where we see the year.

是的，讓我從第一個問題開始，即我們的指導範圍以及我們在今年年初看到的情況。我認為我們的指導範圍是。正如我們在電話會議上所說的那樣，在我們進入市場第五年後，我們非常仔細地研究了我們的歷史財務業績，並利用這些業績來預測今年的情況，這在很大程度上取決於我們現在所了解的情況。

As you may see, obviously the low end of that projection is, sort of flattish to slightly up versus where we were in Q4, at the higher end of that range, obviously gets us into a higher growth category. So, we feel good about the numbers across the board. Do we think they're conservative? No, we think they're based on what we're seeing in the marketplace today.

正如您所看到的，顯然該預測的低端與第四季度的水平相比持平或略有上升，而該範圍的高端顯然使我們進入了更高的增長類別。因此，我們對整體數字感到滿意。我們認為他們是保守派嗎？不，我們認為它們是基於我們今天在市場上看到的情況。

On your second question, I think your point was. There was a little bit of a reiteration of some dates and times and the the mid portion of 2028. I think we can reaffirm, but I do want to just confirm for folks that we're aware here obviously we been aware that NDA filings would begin this year.

關於你的第二個問題，我認為你的觀點是。對一些日期和時間以及 2028 年中期進行了一些重申。我想我們可以重申，但我確實想向大家確認，我們顯然已經知道 NDA 申請將於今年開始。

We have a robust patent portfolio covering LUPKYNIS for its unique chemical entity and obviously also the unique dosing paradigm, which could take us all the way out to 2037. As any company would, and we fully intend to do, we fully intend to vigorously defend LUPKYNIS and our intellectual property rights, protecting the product.

我們擁有強大的專利組合，涵蓋 LUPKYNIS 的獨特化學實體，顯然也包括獨特的劑量模式，這可能會讓我們走到 2037 年。正如任何公司一樣，我們完全打算這樣做，我們完全打算大力捍衛 LUPKYNIS 和我們的智慧財產權，保護產品。

So, more to come as things continue to evolve here, but nothing's changed in terms of the dates and times as far as. Thank you for the question.

所以，隨著事態的不斷發展，還會有更多消息傳出，但就日期和時間而言，沒有任何改變。感謝您的提問。

Thanks

謝謝

Joseph Schwartz, Leerink Partners.

Leerink Partners 的 Joseph Schwartz。

Hey all, this is Will, for Joe today. Thanks for taking our question. Congrats on the progress this quarter. So, just two from us, I guess first, could we just go back and talk a little bit more about your decision to no longer report PSS for the final quarter in 2024? I guess we're just trying to understand why you might make that switch in the middle of the year rather than something as you moves forward in 2025.

大家好，我是威爾，今天為喬主持節目。感謝您回答我們的問題。恭喜本季取得的進展。因此，我們只說兩個問題，首先，我們能否回過頭來再談談您決定不再報告 2024 年最後一個季度的 PSS 的決定？我想我們只是想了解為什麼你可能會在年中做出這樣的改變，而不是在 2025 年的時候做出改變。

How should we be thinking about a trajectory to launch about metrics like this and then one on AUR200. Given it has a lower KDIC50 as compared to other [anti-Aal] assets, is it fair to assume that the higher potency should allow for a lower or less frequent dose? I guess when we're looking at the NHP data, it looks like dosing was once weekly, which is in line with other assets.

我們該如何思考推出類似這樣的指標的軌跡，然後再考慮推出 AUR200 的指標。鑑於與其他 [抗 Aal] 資產相比，它的 KDIC50 較低，是否可以公平地假設更高的效力應該允許更低或更低頻率的劑量？我想，當我們查看 NHP 數據時，看起來劑量是每週一次，這與其他資產一致。

So, can you help us understand this dynamic and the potential differentiation here versus other therapies and development? Thank you.

那麼，您能幫助我們理解這種動態以及與其他療法和發展相比的潛在差異嗎？謝謝。

So, I'll start with the first question and then I'll ask Greg to jump in and obviously remind I mean want to state of what we've reported, not necessarily what's speculative.

因此，我將從第一個問題開始，然後我將請格雷格加入討論，顯然提醒一下，我的意思是要陳述我們已經報告的內容，而不一定是推測的內容。

So, as we said on the call, we're now five years into this or we're into our fifth year on the market, and we believe confidently that our historical financial results provide enough insight, sufficient insight into the health of our business to project it on a forward basis.

因此，正如我們在電話會議上所說的那樣，我們現在已經進入這個行業五年了，或者說我們已經進入了市場第五個年頭，我們有信心相信，我們的歷史財務業績提供了足夠的洞察力，足以洞察我們業務的健康狀況，從而可以對其進行前瞻性預測。

We're excited to have grown the product more than 35% this year in 2024, and we're guiding LUPKYNIS revenues this year at $240 million to $250 million and on a total company basis $250 million to $260 million.

我們很高興該產品在 2024 年實現了 35% 以上的成長，我們預計今年 LUPKYNIS 的營收將達到 2.4 億至 2.5 億美元，公司總收入將達到 2.5 億至 2.6 億美元。

We made the decision at year end because we thought it was the best time. I think you mentioned mid-year. We actually believed that doing it now was the best time to do it.

我們在年底做出了這個決定，因為我們認為那是最好的時機。我覺得你提到了年中。我們確實相信現在做這件事是最好的時機。

We look forward to reporting out on the key commercial strategy areas that I mentioned on the call and mentioned in the previous question as we focused on them as our drivers for 2025 and beyond. Greg, do you want to take the next one?

我們期待報告我在電話會議中提到的以及上一個問題中提到的關鍵商業策略領域，因為我們將它們作為 2025 年及以後的驅動力。格雷格，你想搭乘下一班嗎？

Sure. So, you were referencing information that had been reported and presented at the American College of Rheumatology meeting 2022. And what you alluded to was the fact that AUR200 in the preclinical models that we've conducted, we've identified that there's a lower KD and lower IC50. Lower means resulting in equivalent impact with lower amounts of compounds just like you're alluding to.

當然。因此，您引用了 2022 年美國風濕病學會會議上報告和展示的資訊。您提到的事實是，在我們進行的臨床前模型中，AUR200 我們發現 KD 和 IC50 較低。較低意味著像您所暗示的那樣，使用較少的化合物就能產生同等的影響。

So, we think that the potency of AUR200. With the work we've done thus far preclinically is very attractive with regard to the amount of compound you need and perhaps the frequency with which you'd need to give the drug that is less. A milligram per milligram basis and perhaps less frequent dosing.

因此，我們認為 AUR200 的效力。透過我們迄今為止在臨床前所做的工作，就您所需的化合物量以及可能需要的給藥頻率而言，這是非常有吸引力的。以毫克為單位，也許服用頻率較低。

Of course, we're doing conducting a single ascending dose study right now as has been discussed earlier and in people we'll learn exactly what will be the take forward frequency of dosing and the milligram amount that would be appropriate in diseases that we select later. So, thanks for the question, good information at this point and we're ready to move forward.

當然，正如之前討論過的，我們現在正在進行一項單次劑量遞增研究，在人體中，我們將準確地了解給藥的推進頻率和適合我們稍後選擇的疾病的毫克量。所以，感謝您的提問，目前這些資訊很有用，我們已準備好繼續前進。

Ed Arce, HC Wainwright.

埃德阿爾斯、HC溫賴特。

Hey guys, thanks for taking my questions. two for me, firstly, wanted to ask, again, on the ACR treatment guidelines, as you mentioned, one of the key drivers for continuing growth, wanted to get your perspectives on your thoughts on the impact of prescriber perspectives and ultimately their scriptwriting and uptake of LUPKYNIS.

嘿夥計們，謝謝你們回答我的問題。對我來說有兩個問題，首先，我想再次問一下關於 ACR 治療指南的問題，正如您所提到的，它是持續增長的關鍵驅動力之一，我想了解您對處方者觀點的影響的看法，以及最終他們對 LUPKYNIS 的腳本編寫和吸收的影響。

Especially since, historically, scriptwriting from rheumatologists has been a bit more difficult to penetrate than nephrologists. And then secondly, with regard to AUR200, just wondering if you could, help us understand, as you think about the timeline coming out of the SAD and then later this year into the MAD studies.

尤其從歷史上看，風濕病學家的劇本寫作比腎臟科醫生的劇本寫作更難理解。其次，關於 AUR200，我想知道您是否可以幫助我們理解，您考慮過 SAD 的時間表，以及今年稍後 MAD 研究的時間表。

What's the longer-term timeline look like as you think about ultimately selecting an initial indication and moving into an early phase two.

當您考慮最終選擇初步適應症並進入第二階段的早期階段時，長期時間表是什麼樣的。

Thank you.

謝謝。

Thanks for the question, Ed. On the ACR treatment guidelines to oversimplify for folks on the call, the two biggest areas, and there really are, actually I'll go quickly three that we see as being hugely beneficial for the market treatment, patients and physicians. One is early diagnosis and treat to target guidelines.

謝謝你的提問，艾德。關於 ACR 治療指南，為了向電話會議中的人們簡化，我簡要介紹兩個最大的領域，實際上，我會快速介紹三個我們認為對市場治療、患者和醫生非常有益的領域。一是早期診斷、針對性治療。

Basically, do proteinuria screens on every patient that has SLE when they enter the office, and that's a rheumatologist's office. That doesn't happen today.

基本上，當每個患有 SLE 的患者進入風濕病醫生的辦公室時，都會對他們進行蛋白尿篩檢。今天不會再發生這樣的事情了。

Second, when they hit a target level UPCR to treat. And we know today that somewhere around when they hit those target levels, only 30% of those patients even get treated. Huge opportunity. And then lastly, regardless of the product that they're on, that they need to be kept on that product for up to three to five years.

第二，當UPCR達到目標水準時進行治療。我們今天知道，當達到目標水平時，只有 30％ 的患者能夠得到治療。巨大的機會。最後，無論他們使用什麼產品，他們都需要使用該產品長達三到五年。

And we know today that no matter what the product is, there's more of a mindset to treat to a time period where the proteinuria goes down and then selectively potentially, they remove medication which we know from our data that patients then have to be restarted on the product. So, all three of those are benefits to patients with LN, the overall market, and of course our product.

我們今天知道，無論使用什麼產品，人們更傾向於在蛋白尿水平下降的時間段內進行治療，然後選擇性地停用藥物，而我們從數據中得知，患者隨後必須重新開始使用該產品。因此，這三者對 LN 患者、整個市場以及我們的產品都有好處。

So, impact on behaviours, what I can tell you is greater than 50% of our prescriptions today come from rheumatologists, and that number is slowly growing.

因此，就對行為的影響而言，我可以告訴你的是，今天我們超過 50% 的處方來自風濕病學家，而且這個數字還在慢慢增長。

We have not seen massive change, at least in the macro data that we have in terms of earlier diagnoses yet, but we have to recognize that the ACR guidelines only came out in November. So, I think there's plenty of time, where these guidelines along with the ULA guidelines and the Código guidelines are all very positive for the LN market going forward and our product.

我們還沒有看到巨大的變化，至少在早期診斷方面的宏觀數據方面還沒有，但我們必須認識到 ACR 指南在 11 月才發布。因此，我認為有足夠的時間，這些指南以及 ULA 指南和 Código 指南對於未來的 LN 市場和我們的產品都非常有利。

So, we'll look forward to reporting numbers on marketed as we go forward, but that's the high level. We're seeing some impact and we look forward to seeing more impact on actual treatment and diagnosis behaviors moving forward.

因此，我們期待在未來報告市場上的數字，但這是高水準的。我們看到了一些影響，並期待看到對實際治療和診斷行為產生更多影響。

In terms of your question on AUR200 time and once we get out of the SAD and into the MAD, our longer-term timelines, well, what I would say is let us get through the single ascending dose trial. Let us articulate what our approach to the multi is going to be, and I think that will, whether we give guidance to longer term or not, it will at least give some steer towards where we're going and how long that might take.

關於您關於 AUR200 時間的問題，以及一旦我們擺脫 SAD 並進入 MAD，我們的長期時間表，嗯，我想說的是讓我們完成單次遞增劑量試驗。讓我們清楚地說明我們對多元化的態度，我認為，無論我們是否提供長期指導，它至少都會為我們未來的發展方向和可能花費的時間提供一些指導。

But I think we've got to get through this ad. It's not far away. Look at what those kinetics and dynamic data tell us and use that as an informed decision to move into the MAD study. So more to come.

但我認為我們必須完成這個廣告。不是很遠。看看這些動力學和動態數據告訴我們什麼，並以此作為進入 MAD 研究的明智決定。接下來還有更多。

Thank you for the questions, Ed.

謝謝你的提問，艾德。

Thank you. This concludes our question-and-answer session. I would like to hand the floor back over to Peter Greenleaf for any closing comments.

謝謝。我們的問答環節到此結束。我想將發言權交還給彼得·格林利夫，請他發表最後評論。

I want to thank you all for joining us today. We look forward to a strong 2025 and we'll keep you updated along the way. Have a great day, folks.

我感謝大家今天的出席。我們期待 2025 年取得強勁進展，並將隨時向您通報最新情況。祝大家有個愉快的一天。

This concludes Today's presentation, you may disconnect your lines at this time. Thank you for your participation.

今天的演示到此結束，現在您可以斷開連接了。感謝您的參與。