FibroGen Inc (FGEN) 2024 Q2 法說會逐字稿

Good day and welcome to the FibroGen second quarter 2024 earnings conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 FibroGen 2024 年第二季財報電話會議。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to David DeLucia, VP of Investor Relations. Please go ahead.

我現在想將會議交給投資者關係副總裁 David DeLucia。請繼續。

Good afternoon, everyone. Thank you for joining today to discuss our second quarter 2024 financial and business results. I'm David DeLucia, Vice President of Corporate FP&A and Investor Relations at FibroGen.

大家下午好。感謝您今天加入討論我們 2024 年第二季的財務和業務表現。我是 David DeLucia，FibroGen 企業 FP&A 和投資人關係副總裁。

Joining me on today's call are Thane Wettig, our Chief Executive Officer; Dr. Deyaa Adib, our Chief Medical Officer; Juan Graham, our Chief Financial Officer; Chris Chung, our Senior Vice President of China Operations, and Dr. John Hunter, our Chief Scientific Officer. Following our prepared remarks, we will open the call to your questions.

參加今天電話會議的還有我們的執行長 Thane Wettig； Deyaa Adib 博士，我們的首席醫療官；胡安‧格雷厄姆，我們的財務長；我們的中國業務資深副總裁 Chris Chung 和我們的首席科學長 John Hunter 博士。在我們準備好的發言之後，我們將開始回答您的問題。

I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include, but are not limited to our collaborations with AstraZeneca and Astellas, financial guidance, the initiation, enrollment, design, conduct and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results and results of operations, risks related to our business and certain other business matters.

我想提醒您，今天電話會議的言論包括有關 FibroGen 的前瞻性陳述。此類聲明可能包括但不限於我們與阿斯特捷利康和安斯泰來的合作、財務指導、臨床試驗的啟動、註冊、設計、實施和結果、我們的監管策略和潛在的監管結果、我們的研發活動、商業結果營運結果、與我們業務相關的風險以及某些其他業務事項。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in FibroGen's filings with the SEC, including our most recent Form 10-K and Form 10-Q.

每項前瞻性陳述都存在風險和不確定性，可能導致實際結果和事件與該陳述中的預測有重大差異。這些風險和其他重大風險的更完整描述可以在 FibroGen 向 SEC 提交的文件中找到，包括我們最新的表格 10-K 和表格 10-Q。

FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found in the Investors section of FibroGen's website at www.fibrogen.com.

FibroGen 不承擔公開更新任何前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。報告我們財務表現和業務更新的新聞稿以及今天電話會議的網路廣播可在 FibroGen 網站 www.fibrogen.com 的投資者部分找到。

With that, I'd like to turn the call over to our CEO, Thane Wettig.

說到這裡，我想將電話轉給我們的執行長 Thane Wettig。

Thanks, Dave, and good afternoon, everyone and welcome to our second quarter 2024 earnings call. On today's call, I will focus our stakeholders on the updated go-forward strategy for the company and highlight the attractive opportunities that FibroGen has in front of it.

謝謝戴夫，大家下午好，歡迎參加我們的 2024 年第二季財報電話會議。在今天的電話會議上，我將讓我們的利害關係人專注於公司最新的前進策略，並強調 FibroGen 面臨的有吸引力的機會。

Dr. Deyaa Adib, our Chief Medical Officer will provide an overview of the prostate cancer landscape, discuss the development plan of our CD46 targeted antibody drug conjugate, FG-3246 and associated PET46 imaging agent in metastatic castration-resistant prostate cancer and articulate why we feel so strongly about recently released Phase 1 top-line results. And Juan Graham, our CFO will review the financials after which we will open the call for your questions.

我們的首席醫療官Deyaa Adib 博士將概述前列腺癌的概況，討論我們的CD46 靶向抗體藥物偶聯物、FG-3246 和相關PET46 顯像劑在轉移性去勢抵抗性前列腺癌中的開發計劃，並闡明我們的原因對最近發布的第一階段的頂線結果有如此強烈的感覺。我們的財務長胡安·格雷厄姆將審查財務狀況，然後我們將召開電話會議詢問您的問題。

On slide 3, I would like to provide a recap of the recently announced late-stage pamrevlumab clinical trial results in pancreatic cancer. Last week, we reported top-line data from the pamrevlumab experimental arm in PanCANs, Precision Promise Phase 2/3 adaptive platform trial which compare treatment with pamrevlumab combined with gemcitabine plus nab-paclitaxel, two gemcitabine plus nab-paclitaxel alone for the treatment in first line and second line patients with metastatic pancreatic ductal adenocarcinoma.

在投影片 3 上，我想回顧最近宣布的胰臟癌晚期 pamrevlumab 臨床試驗結果。上週，我們報告了PanCANs（Precision Promise 2/3 期適應性平台試驗）中pamrevlumab 實驗組的頂線數據，該試驗比較了pamrevlumab 聯合吉西他濱加白蛋白結合型紫杉醇、兩種吉西他濱加白蛋白結合型紫杉醇單獨治療的治療效果。

The pamrevlumab arm of the study did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis.

研究的 pamrevlumab 組未達到根據方案預先指定的貝葉斯統計分析所確定的總存活期的主要終點。

We also announced top-line data from the FibroGen-sponsored Phase 3 LAPIS trial which compared treatment with pamrevlumab combined with gemcitabine plus nab-paclitaxel or FOLFIRINOX to placebo combined with gem plus nab-paclitaxel or FOLFIRINOX for the treatment of locally advanced unresectable pancreatic cancer. The study also did not meet the primary endpoint of overall survival.

我們也發表了FibroGen 贊助的3 期LAPIS 試驗的主要數據，該試驗比較了pamrevlumab 聯合吉西他濱加白蛋白結合型紫杉醇或FOLFIRINOX 與安慰劑聯合吉姆加白蛋白結合型紫杉醇或FOLFIRINOX 治療局部晚期不可切除胰腺癌的療效。該研究也沒有達到總存活期的主要終點。

When FibroGen advanced pamrevlumab into Phase 3 development, we knew the challenges associated with a first-in-class mechanism targeted at three very difficult diseases, idiopathic pulmonary fibrosis, duchenne muscular dystrophy and pancreatic cancer.

當 FibroGen 將 pamrevlumab 推進到 3 期開發時，我們知道針對三種非常困難的疾病（特發性肺纖維化、杜氏肌肉營養不良症和胰腺癌）的一流機制所面臨的挑戰。

Diseases with substantial unmet need and little advancement in patient outcomes over the past several years. Most unfortunately for patients as well as other FibroGen stakeholders, pamrevlumab will not be a solution that will enable patients to live longer and more productive lives.

過去幾年中，需求大量未被滿足且患者治療效果幾乎沒有改善的疾病。對於患者和其他 FibroGen 利害關係人來說，最不幸的是，pamrevlumab 不會成為使患者活得更長、更有成效的生活的解決方案。

Specific to prostate -- to pancreatic cancer, we were hopeful that pamrevlumab would demonstrate a meaningful overall survival benefit, especially after we learned that the graduation from Stage 1 to Stage 2 as a precision promise adaptive platform trial. This was simply not the result. We would like to thank the patients and clinical trial investigators for their dedication and participation in both pancreatic cancer trials.

具體到前列腺癌和胰腺癌，我們希望 pamrevlumab 能夠表現出有意義的整體生存獲益，特別是在我們了解到從第 1 階段升級到第 2 階段作為精準承諾適應性平台試驗之後。這根本就不是結果。我們要感謝患者和臨床試驗研究者對兩項胰臟癌試驗的奉獻和參與。

Due to these results, the company is implementing a significant cost reduction plan which unfortunately includes reducing headcount in the US by approximately 75%. I would like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity.

鑑於這些結果，該公司正在實施一項重大成本削減計劃，不幸的是，其中包括將美國員工人數減少約 75%。我謹向我們的 FibroGen 同事表示最深切的感謝，他們投入了大量的時間和精力，為一些影響人類的最具挑戰性和致命的疾病帶來急需的治療方法。

On slide 4, I would like to highlight the exciting assets that FibroGen has. First is FG-3246, a first-in-class potent antibody drug conjugate or ADC targeting CD46 for the treatment of metastatic castration-resistant prostate cancer and potentially other solid tumors. This program also includes the development of an associated CD46 targeted PET imaging agent.

在投影片 4 上，我想強調 FibroGen 擁有的令人興奮的資產。首先是 FG-3246，這是一種針對 CD46 的一流的強效抗體藥物偶聯物或 ADC，用於治療轉移性去勢抵抗性前列腺癌和其他潛在的實體瘤。該計劃還包括開發相關的 CD46 靶向 PET 成像劑。

In April, we released compelling data from our FG-3246 Phase 1 monotherapy trial and in June, additional compelling preliminary data from the dose escalation portion of the Phase 1/2 investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC.

4 月，我們發布了FG-3246 1 期單藥治療試驗的令人信服的數據，6 月，我們發布了FG-3246 與恩雜魯胺聯合治療患有以下疾病的1/2 期研究的劑量遞增部分的額外令人信服的初步數據： mCRPC。

The combination data was presented at the 2024 ASCO Annual Meeting. Deyaa will provide more detail on these two Phase 1 studies later in the call. We anticipate two catalysts for FG-3246 in 2025. Top line data from the Phase 2 portion of the combination trial in the first half of 2025 and the initiation of the Phase 2 monotherapy trial in the first quarter of 2025.

組合資料已在 2024 年 ASCO 年會上公佈。Deyaa 將在稍後的電話會議中提供有關這兩項一期研究的更多詳細資訊。我們預計 2025 年 FG-3246 將有兩種催化劑。來自 2025 年上半年聯合試驗 2 期部分和 2025 年第一季啟動的 2 期單藥試驗的主要數據。

Second is roxadustat. Roxadustat is approved in over 40 countries, generates significant net revenue and positive cash flow and provides FibroGen with material and growing economics through our partnerships with AstraZeneca and Astellas Pharma.

其次是羅沙司他。Roxadustat 在 40 多個國家獲得批准，產生可觀的淨收入和正現金流，並透過我們與阿斯特捷利康和安斯泰來製藥的合作夥伴關係為 FibroGen 提供材料和不斷增長的經濟效益。

Due to strong roxadustat performance in China, we are raising our guidance for full year 2024. We now expect FibroGen's full year net product revenue under US GAAP to be between $130 million -- $135 million and $150 million, up from $120 million to $135 million and full year roxadustat net sales in China of $320 million to $350 million, up from our previous guidance of $300 million to $340 million. Juan will cover our financials in more detail later in the call.

由於羅沙司他在中國的強勁表現，我們上調了 2024 年全年指引。我們現在預計，根據美國通用會計準則，FibroGen 的全年淨產品收入將在1.3 億美元至1.35 億美元至1.5 億美元之間，從1.2 億美元升至1.35 億美元，羅沙司他在中國的全年淨銷售額為3.2 億美元至3.5 億美元，高於我們的預期。胡安將在稍後的電話會議中更詳細地介紹我們的財務狀況。

We are also expecting an approval decision from the China authorities in the second half of 2024 for chemotherapy-induced anemia, which if approved would represent meaningful revenue growth on top of the substantial revenue generated by roxadustat in anemia associated with chronic kidney disease.

我們也預期中國當局將於2024 年下半年批准治療化療引起的貧血的決定，如果獲得批准，除了羅沙司他治療慢性腎病相關貧血所產生的可觀收入之外，這將代表著有意義的收入增長。

Next, FibroGen has a number of partnering opportunities for our remaining pipeline. Earlier this year, we regained the rights to roxadustat from AstraZeneca in the US and ROW territories, excluding China and South Korea. This allows us the opportunity to potentially partner roxadustat in certain indications with high unmet needs such as anemia in patients with lower-risk myelodysplastic syndromes.

接下來，FibroGen 為我們剩餘的產品線提供了許多合作機會。今年早些時候，我們從阿斯特捷利康手中奪回了羅沙司他在美國和其他地區（不包括中國和韓國）的權利。這使我們有機會在某些需求未被滿足的適應症上與羅沙司他合作，例如低風險骨髓增生異常綜合症患者的貧血。

Based on the data presented at ASH in December of last year, which demonstrated a meaningful difference in transfusion independence between roxadustat and placebo in patients with anemia associated with lower-risk MDS, who entered the trial with a higher transfusion burden, we believe roxadustat is an excellent candidate for a focused Phase 3 trial in lower-risk MDS, a condition which represents a significant unmet need with a substantial commercial opportunity.

根據去年12 月ASH 上公佈的數據，該數據表明，對於低風險MDS 相關貧血患者（以較高的輸血負擔進入試驗），羅沙司他和安慰劑之間的輸血獨立性存在顯著差異，我們認為羅沙司他是低風險 MDS 重點 3 期試驗的優秀候選者，這種情況代表了重大未滿足的需求，並具有巨大的商業機會。

Second, we have made a difficult decision to stop internal development of the two immuno-oncology programs we licensed for HiFiBiO in 2021.

其次，我們做出了一個艱難的決定，停止我們在 2021 年為 HiFiBiO 授權的兩個免疫腫瘤學計畫的內部開發。

Given the organizational changes we announced last week, we simply don't have the substrate to advance these programs as quickly as they deserve. We continue to be very excited about the potential of these programs and believe there are partnering opportunities for both of these assets.

鑑於我們上週宣布的組織變革，我們根本沒有足夠的基礎來盡快推進這些計劃。我們仍然對這些計劃的潛力感到非常興奮，並相信這兩項資產都有合作機會。

We have made important advancements to derisk these programs including optimizing the affinity of and receiving IND clearance for FG-3165 our anti-galectin-9 monoclonal antibody enabling the product to be Phase 1 ready. We have also made significant progress optimizing the activity of FG-3175, our anti-CCR8 monoclonal antibody, advancing it to a point where we believe it has best-in-class potential.

我們已經取得了重要進展來消除這些項目的風險，包括優化 FG-3165 的親和力並獲得 IND 許可，我們的抗半乳糖凝集素 9 單株抗體使該產品能夠進入第一階段。我們也在優化我們的抗 CCR8 單株抗體 FG-3175 的活性方面取得了重大進展，使其達到了我們認為具有同類最佳潛力的水平。

As we announced in June, we have also signed a clinical trial supply agreement with Regeneron to study both of these assets in combination with LIBTAYO. We will begin partnering discussions for both FG-3165 and FG-3175 with interested parties in the near future.

正如我們在 6 月宣布的那樣，我們還與 Regeneron 簽署了臨床試驗供應協議，與 LIBTAYO 結合研究這兩種資產。我們將在不久的將來開始與有興趣的各方就 FG-3165 和 FG-3175 進行合作討論。

Lastly is our strong cash position. We finished the second quarter with approximately $147.1 million in cash, cash equivalents and accounts receivable. We expect our balance sheet to be sufficient to fund our operating plans into 2026. In summary, we believe that we have a strong foundation to drive significant shareholder value creation today and into the future.

最後是我們強勁的現金狀況。第二季末，我們的現金、現金等價物和應收帳款約為 1.471 億美元。我們預計我們的資產負債表足以為我們 2026 年的營運計劃提供資金。總之，我們相信我們擁有堅實的基礎來推動今天和未來創造顯著的股東價值。

I will now turn the call over to Deyaa Adib, our Chief Medical Officer to discuss prostate cancer and FG-3246. Deyaa?

我現在將把電話轉給我們的首席醫療官 Deyaa Adib，討論前列腺癌和 FG-3246。德亞？

Thank you, Thane. Moving on to slide 6, I would like to provide a brief overview of the prostate cancer landscape and the high unmet need in late-stage disease. Prostate cancer is the most common cancer in men in the United States who currently have a one in eight lifetime risk of developing the disease.

謝謝你，塔恩。轉到第 6 張投影片，我想簡要概述前列腺癌的概況以及晚期疾病中未滿足的高度需求。攝護腺癌是美國男性最常見的癌症，目前八分之一的男性終生罹患此疾病的風險。

There are approximately 290,000 new diagnosis of prostate cancer each year in the US, with 65,000 diagnoses where the cancer has metastasized, became castrate-resistant and are drug treatable. The five-year survival rate in these late-stage patients is approximately 30%.

美國每年約有 29 萬例新診斷出前列腺癌，其中 65,000 例診斷出的癌症已發生轉移、具有去勢抵抗性且可以透過藥物治療。這些晚期患者的五年存活率約為 30%。

There is a significant unmet medical need for therapies that extend survival in these late-stage patients that have progressed on androgen receptor signaling inhibitors or ARSI and chemotherapy.

對於這些在雄性激素受體訊號抑制劑或 ARSI 和化療後病情進展的晚期患者來說，延長存活期的治療方法存在顯著的未滿足的醫療需求。

Turning to slide 7. FG-3246 is a potential first-in-class ADC targeting CD46 in development for metastatic castration-resistant prostate cancer. With potential future development in colorectal cancer and other tumor types, FG-3246 binds to a cell receptor target that internalizes upon antibody binding and is present in approximately 50% to 70% of prostate tumors.

轉到投影片 7。FG-3246 是一種潛在的一流 ADC，靶向 CD46，正在開發用於治療轉移性去勢抵抗性前列腺癌。隨著大腸直腸癌和其他腫瘤類型未來的潛在發展，FG-3246 與細胞受體標靶結合，該標靶在抗體結合後內化，存在於約 50% 至 70% 的前列腺腫瘤中。

But that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate. FG-3246 is comprised of an anti-CD46 antibody (technical difficulty) linked to the [anti-mitotic agent], MMAE which is a clinically validated and FDA approved ADC payload.

但這表明在大多數正常組織中表達非常有限，使其成為理想的 ADC 候選標靶。FG-3246 由與[抗有絲分裂劑] MMAE 連接的抗 CD46 抗體（技術難度）組成，MMAE 是經過臨床驗證並獲得 FDA 批准的 ADC 有效負載。

And associated PET imaging agent, PET46, utilizes the same targeting antibody as FG-3246 and is under clinical development at UCSF. It is constituted of the YS-5 antibody composed to the radionuclide zirconium-89 and in preclinical studies demonstrates specific targeting of an uptake by CD46 positive tumor cells.

相關的 PET 顯影劑 PET46 使用與 FG-3246 相同的標靶抗體，並正在 UCSF 進行臨床開發。它由針對放射性核素 zircium-89 的 YS-5 抗體組成，在臨床前研究中表明，它可以特異性靶向 CD46 陽性腫瘤細胞的攝取。

On slide 8, we highlight the importance of the companion PET imaging agent PET46 to the development pathway of FG-3246. We believe that utilizing PET46 as a patient selection biomarker will allow FG-3246 to achieve a differentiated clinical profile in prostate cancer treatment paradigm.

在投影片 8 中，我們強調了配套 PET 顯影劑 PET46 對 FG-3246 開發途徑的重要性。我們相信，利用 PET46 作為患者選擇生物標記將使 FG-3246 在前列腺癌治療模式中實現差異化的臨床特徵。

We believe that PET46 biomarker will be superior to CD46 IHC due to the fact that PET46 is applicable to the entire mCRPC population, while IHC is reserved for patients who have biopsy accessible disease. This will allow the company to better enrich the patient population turning throughout the clinical development program.

我們相信 PET46 生物標記將優於 CD46 IHC，因為 PET46 適用於整個 mCRPC 族群，而 IHC 則保留用於活檢可檢測疾病的患者。這將使公司能夠更好地豐富整個臨床開發專案的患者群體。

Now, let's go into the top-line results from the monotherapy Phase 1 study in metastatic CRPP slide 9. In the Phase 1 dose escalation component of the trial, dose levels of FG-3246 were administered in 21-day cycles.

現在，讓我們來看看轉移性 CRPP 單一療法 1 期研究的主要結果（投影片 9）。在試驗的 1 期劑量遞增部分中，FG-3246 的劑量水準以 21 天為週期進行給藥。

In the dose expansion arm of the trial patients were treated at 2.7 milligrams per kg adjusted body weight capping to 100 kilograms until disease progression or the occurrence of an unacceptable toxicity for example ADLD.

在試驗的劑量擴展組中，患者接受每公斤 2.7 毫克的劑量治療，體重上限調整為 100 公斤，直到疾病進展或出現不可接受的毒性（例如 ADLD）。

The endpoints were safety tolerability and anti-tumor activity as measured by the decline of prosthetic specific antigen from baseline, objective tumor response rate in patients who have measurable disease and radiographic progression-free survival using the prostate cancer working group criteria for tumor response assessment.

終點是安全耐受性和抗腫瘤活性（透過假體特異性抗原相對於基線的下降來衡量）、具有可測量疾病的患者的客觀腫瘤反應率以及使用前列腺癌工作組腫瘤反應評估標準的放射學無惡化存活期。

The completed Phase 1 trial includes a total of 56 metastatic castration-resistant prostate cancer patients, who are biomarker unselected and have received a median of five prior lines of therapy before they were administered FG-3246.

已完成的 1 期試驗總共包括 56 名轉移性去勢抵抗性前列腺癌患者，這些患者未選擇生物標記物，並且在服用 FG-3246 之前已接受過中位五線治療。

In the efficacy population, we observed a median radiographic progression-free survival of 8.7 months. For RECIST evaluable patients, 20% met the criteria of a partial response or a tumor reduction in size of at least 30% with a median duration of response of 7.5 months. PSA reductions of more than 50% were observed in 36% of patients.

在有效族群中，我們觀察到中位影像學無惡化存活期為 8.7 個月。對於 RECIST 可評估的患者，20% 的患者符合部分緩解或腫瘤大小至少縮小 30% 的標準，中位緩解持續時間為 7.5 個月。36% 的患者觀察到 PSA 下降超過 50%。

FG-3246 demonstrated an acceptable safety profile with adverse events consistent with those observed in other antibody drug conjugate therapies that have an MMAE payload. We look forward to publishing the totality of the Phase 1 data in the manuscript in the upcoming months, as we plan the advancement of the program further in the clinic.

FG-3246 表現出可接受的安全性，其不良事件與其他具有 MMAE 有效負載的抗體藥物偶聯療法中觀察到的不良事件一致。我們期待在未來幾個月內發布手稿中第一階段數據的全部內容，同時我們計劃在臨床上進一步推進該專案。

Moving to slide 10. There is also a combination study with enzalutamide that is currently being run at UCSF as a sponsored trial as a investigator-sponsored trial. We announced positive interim results from this dose escalation component of the study which is a Phase 1b/2 trial of FG-3246 in combination with enzalutamide in patients with mCRPC at the ASCO 2024 Annual Meeting.

轉到投影片 10。還有一項與恩雜魯胺的聯合研究，目前正在加州大學舊金山分校作為研究者贊助的試驗進行。我們在 ASCO 2024 年年會上宣布了該研究的劑量遞增部分的積極中期結果，該研究是 FG-3246 聯合恩雜魯胺治療 mCRPC 患者的 1b/2 期試驗。

The presentation included data from 17 biomarker unselected patients in the dose escalation component of the study. Over 70% of patients in the study received at least two prior ARSI, which included prior enzalutamide. The primary endpoint was determination of the maximally tolerated dose or MTD for FG-3246 in combination with enzalutamide.

該簡報包括研究劑量遞增部分中 17 名未選擇生物標記患者的數據。研究中超過 70% 的患者至少接受過兩次 ARSI，其中包括先前接受過恩雜魯胺。主要終點是確定 FG-3246 與恩雜魯胺合併使用的最大耐受劑量或 MTD。

The MTD was established at 2.1 milligram per kg adjusted body weight with primary GCSF prophylaxis in combination with enzalutamide at the prescription dose of 160 milligrams per day. The combination treatment demonstrated an encouraging preliminary result showing an estimate of radiographic PFS of 10.2 months with PSA declining observed in 71% or 12 out of 17 evaluable patients.

MTD 確定為每公斤調整體重 2.1 毫克，初級 GCSF 預防結合恩雜魯胺（處方劑量為每天 160 毫克）。聯合治療顯示出令人鼓舞的初步結果，顯示影像學 PFS 估計為 10.2 個月，其中 71% 或 17 名可評估患者中的 12 名觀察到 PSA 下降。

We're excited to announce that we expect top-line results from the Phase 2 component of this investigator-initiated study in first half of 2025. And these results will also include additional data on patients screened with PET46 during the Phase 2 component enrollment periods.

我們很高興地宣布，我們預計這項由研究者發起的研究的第 2 階段部分將在 2025 年上半年得到頂線結果。這些結果還將包括在第 2 階段的入組期間使用 PET46 篩檢的患者的額外數據。

On slide 11, I would like to discuss a few endpoints in metastatic CRPC. We believe that the radiographic PFS is a clinically meaningful endpoint versus other surrogate signals such as PSA50 and objective response rate.

在投影片 11 上，我想討論轉移性 CRPC 的幾個終點。我們認為，與 PSA50 和客觀緩解率等其他替代訊號相比，放射學 PFS 是一個具有臨床意義的終點。

Other earlier stage data in the same space has only shown results from PSA30 and PSA50 as signals of clinical activity in a very limited number of patients, but have not yet shown survival data, which constitutes the clinically meaningful endpoints in metastatic castration resistant prostate cancer.

其他同一領域的早期數據僅顯示 PSA30 和 PSA50 的結果作為極少數患者的臨床活動訊號，但尚未顯示存活數據，而存活數據構成了轉移性去勢抵抗性前列腺癌的臨床有意義的終點。

For FG-3246, we believe a radiographic PFS of 8.7 months as monotherapy in heavily pretreated unselected population and radiographic PFS of 10.2 months in combination with enzalutamide in an earlier treatment line with pre-treated ARSI patients is very compelling versus existing standard of care in the mCRPC set.

對於FG-3246，我們認為，與接受過嚴格治療的未選擇人群中的單一療法相比，放射學PFS 為8.7 個月，與接受過治療的ARSI 患者的早期治療線中與恩雜魯胺聯合使用的放射學PFS 為10.2 個月，與現有的護理標準相比，非常引人注目。

Moving to slide 12. We highlight all the recent and ongoing studies for FG-3246. We are expecting to see more data generated for PET46 biomarker in prostate cancer that is in progress at UCSF this year. As we have articulated the goal is to develop a companion PET imaging agent to select those patients with high CD46 expression who are most likely to benefit from the treatment with FG-3246.

轉到投影片 12。我們重點介紹 FG-3246 的所有近期和正在進行的研究。我們預計今年將在加州大學舊金山分校 (UCSF) 取得更多有關前列腺癌 PET46 生物標記的數據。正如我們所闡明的，我們的目標是開發一種伴隨 PET 顯影劑，以選擇那些最有可能從 FG-3246 治療中受益的 CD46 高表達患者。

PET46 will be part of a Phase 2 dose optimization monotherapy study sponsored by FibroGen and could potentially enhance screening, patient selection and enrichment ensuring proper selection of patients for the targeted therapy to receive a clinically meaningful benefit.

PET46 將成為 FibroGen 贊助的 2 期劑量優化單一療法研究的一部分，有可能加強篩檢、患者選擇和充實，確保正確選擇患者進行標靶治療，以獲得臨床上有意義的益處。

On slide 13, we highlight the upcoming catalysts for FG-3246 program. We are meeting with the FDA this quarter. We expect to file FibroGen's IND for FG-3246 this quarter, as well as filing the FibroGen's IND for PET46 next quarter.

在投影片 13 上，我們重點介紹了 FG-3246 計畫即將推出的催化劑。我們本季將與 FDA 會面。我們預計本季將提交 FibroGen 的 FG-3246 IND，並在下季提交 FibroGen 的 PET46 IND。

We anticipate the initiation of a Phase 2 dose optimization study in mCRPC in the first quarter of 2025 and expect top-line results from the Phase 2 portion of the combination study being run at UCSF in combination with enzalutamide in first half of 2025.

我們預計將於 2025 年第一季啟動 mCRPC 的 2 期劑量優化研究，並預計 UCSF 合併恩雜魯胺聯合研究的 2 期部分將於 2025 年上半年獲得頂線結果。

Finally moving to slide 14. We want to summarize the unique opportunity that FG-3246 represents. The molecule represents a novel [mechanism] of action and a first-in-class opportunity bearing an antibody against a novel target with a validated chemotherapy payload.

最後轉到投影片 14。我們想要總結 FG-3246 所代表的獨特機會。該分子代表了一種新穎的作用機制和一流的機會，該抗體具有針對具有經過驗證的化療有效負載的新標靶的抗體。

FG-3246 may offer a treatment beyond prostate cancer with potential applications in multiple treatment lines of mCRPC in combination with enzalutamide and other solid tumors such as colorectal cancer.

FG-3246 可能提供前列腺癌以外的治療方法，與恩雜魯胺和其他實體瘤（如結直腸癌）聯合使用，可能應用於 mCRPC 的多種治療線。

FG-3246 could potentially represent a paradigm shift in oncology offering not only a novel mechanism of action but also promising efficacy, safety and potential across various cancer types. We look forward to updating you on FG-3246 as studies progress.

FG-3246 可能代表腫瘤學的範式轉變，不僅提供一種新穎的作用機制，而且在各種癌症類型中具有良好的功效、安全性和潛力。隨著研究的進展，我們期待為您提供有關 FG-3246 的最新資訊。

I will now turn the call back to Thane to discuss roxadustat. Thane?

我現在將電話轉回塔恩，討論羅沙司他。領主？

Thank you, Deyaa. Moving now to slide 16. Roxadustat for anemia of chronic kidney disease continues to perform extremely well in China. Second quarter total roxadustat net sales in China by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca totaled $92.3 million compared to $76.4 million in the second quarter of 2023, an increase of 21%.

謝謝你，德亞。現在轉到投影片 16。羅沙司他治療慢性腎臟病貧血在中國持續表現優異。FibroGen 以及 FibroGen 和阿斯特捷利康共同擁有的分銷實體第二季度羅沙司他在中國的淨銷售額總計 9,230 萬美元，較 2023 年第二季的 7,640 萬美元增長 21%。

This growth was driven by an increase in volume of 33%. FibroGen's portion of roxadustat net product revenue in China was $49.6 million for the second quarter on a US GAAP basis compared to $23.9 million in the second quarter of 2023, an increase of 108%.

這一增長是由 33% 的銷售成長推動的。以美國通用會計準則計算，第二季 FibroGen 在中國的 roxadustat 淨產品收入部分為 4,960 萬美元，而 2023 年第二季為 2,390 萬美元，成長了 108%。

Moving to slide 17. Roxadustat continues its category leadership and brand value share in China, maintaining a 46% share in the most recent three months period ending in May of 2024. The potential addition of the chemotherapy-induced anemia indication would provide an important new treatment alternative for patients with chemotherapy induced anemia and meaningful addition to the roxadustat business in China.

轉到投影片 17。Roxadustat 繼續保持其在中國的品類領導地位和品牌價值份額，在截至 2024 年 5 月的最近三個月內保持著 46% 的份額。潛在增加化療引起的貧血適應症將為化療引起的貧血患者提供一個重要的新治療選擇，並有意義地增加羅沙司他在中國的業務。

Given there have been several generic applications filed and two applications approved in China, I would like to reiterate the dynamics of the generic market in China and the exclusivity of roxadustat. The impact of a generic approval and launch in China is meaningfully different than in the US market. Generic players face lead time and execution risk of market adoption after approval as they need to be admitted into individual hospital formularies one listing at a time.

鑑於中國已提交多項仿製藥申請並批准兩項申請，我想重申中國仿製藥市場的動態以及羅沙司他的排他性。在中國仿製藥批准和上市的影響與在美國市場明顯不同。仿製藥企業在獲得批准後面臨著市場採用的前置時間和執行風險，因為它們需要一次一個地進入各個醫院的處方集。

Originator products do not experience a meaningful deterioration in revenue until they are subjected to volume-based purchasing, which only occurs after at least four generic products are approved and the government includes the originator in the [VBT] process.

原創產品在進行大量採購之前不會出現收入大幅下降，而批量採購只有在至少四種仿製藥獲得批准並且政府將原創產品納入 [VBT] 流程後才會發生。

Even then, originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market. Despite the expiration of our composition of matter patents in June of 2024, we do not expect meaningful deterioration of the roxadustat business in the near term.

即便如此，從歷史上看，中國的原廠藥在仿製藥進入市場後仍能維持源源不絕的淨收入和利潤。儘管我們的物質組合專利已於 2024 年 6 月到期，但我們預期羅沙司他業務短期內不會出現明顯惡化。

In addition to the continued outstanding performance of roxadustat in China, roxadustat penetration in Europe continues to increase showing quarter-over-quarter growth. We expect this growth to continue given the fact that roxadustat is reimbursed in all EU five countries and is the only (inaudible) indicated in the EU for the treatment of anemia of CKD in both non-dialysis and dialysis patients.

除了羅沙司他在中國的持續出色表現外，羅沙司他在歐洲的滲透率持續增長，呈現季度環比增長。鑑於羅沙司他在歐盟所有五個國家均可報銷，並且是歐盟唯一（聽不清楚）用於治療非透析和透析患者 CKD 貧血的藥物，我們預計這種增長將持續下去。

Importantly, roxadustat has exclusivity into 2036 in the EU positioning it to continue its growth and market leadership over the next decade plus.

重要的是，roxadustat 在歐盟擁有直至 2036 年的獨家經營權，使其能夠在未來十年內繼續保持成長和市場領先地位。

Moving to slide 18. Earlier in the year. we announced that AstraZeneca returned all US and ROW roxadustat rights to China with the exception of South Korea. FibroGen's collaboration agreement with AZ for roxadustat in China remains firmly in place.

轉到投影片 18。今年早些時候。我們宣布阿斯特捷利康將除韓國以外的所有美國和世界其他地區的羅沙司他權利歸還給中國。FibroGen 與 AZ 就 roxadustat 在中國的合作協議仍然有效。

Regaining the rights to roxadustat in the US allows us to pursue roxadustat development opportunities with potential partners in indications such as anemia associated with lower-risk myelodysplastic syndromes.

重新獲得羅沙司他在美國的權利使我們能夠與潛在合作夥伴一起尋求羅沙司他在低風險骨髓增生異常綜合徵相關貧血等適應症方面的開發機會。

I will now turn the call over to Juan to discuss the company's financials. Juan?

我現在將電話轉給胡安，討論公司的財務狀況。胡安？

Thank you, Thane. Firstly, I would like to take a few moments to thank the entire FibroGen team for their hard work and dedication over the years. The organization has courageously focused on developing therapies in very difficult diseases affecting humanity.

謝謝你，塔恩。首先，我想花一些時間感謝整個 FibroGen 團隊多年來的辛勤工作和奉獻精神。該組織勇敢地致力於開發影響人類的非常困難的疾病的療法。

And while our objective was not achieved, I expect our learnings to provide valuable information for the development of new therapies in the future to provide options for patients affected with pancreatic cancer.

雖然我們的目標沒有實現，但我希望我們的學習成果能為未來新療法的開發提供有價值的信息，為胰腺癌患者提供選擇。

I will focus my remarks with a revenue summary for the second quarter of 2024, subsequently providing financial performance details on our China business for the quarter. And finally, I will wrap up with operating expense results and our cash outlook.

我的發言將重點介紹 2024 年第二季的收入摘要，隨後提供該季度中國業務的財務業績詳細資訊。最後，我將總結營運費用結果和我們的現金前景。

For the second quarter of 2024, total revenue was $50.6 million compared to $44.3 million for the same period in 2023, an increase of 14% year-over-year. We recorded $49.6 million of net product revenue for roxadustat sales in China compared to $23.9 million in the second quarter of 2023, representing an increase of 108% year over year.

2024 年第二季總營收為 5,060 萬美元，而 2023 年同期為 4,430 萬美元，較去年同期成長 14%。羅沙司他在中國的銷售淨產品收入為 4,960 萬美元，而 2023 年第二季為 2,390 萬美元，年增 108%。

The drivers for this increase were, one, volume growth of 33% versus last year. And two, changes in assumptions of our future revenue expectations leading to a deferred revenue release of [$18 million]. Roxadustat performance in China continues to deliver strong results supporting patients with CKD.

這一成長的驅動因素是，第一，銷量比去年增長了 33%。第二，我們對未來收入預期的假設發生變化，導致延遲發布收入[1800萬美元]。Roxadustat 在中國的表現持續為 CKD 患者帶來強勁成果。

In Q2 2024, we recorded $0.3 million in development revenue compared to $5.2 million during the second quarter of 2023. As mentioned last quarter, after the termination of the AstraZeneca US rest of world agreement, we expect quarterly development revenue to be below $0.5 million for the remainder of the year.

2024 年第二季度，我們的開發收入為 30 萬美元，而 2023 年第二季為 520 萬美元。正如上季度所提到的，在阿斯特捷利康美國與世界其他地區協議終止後，我們預計今年剩餘時間的季度開發收入將低於 50 萬美元。

In Q2 2024, we recorded $0.7 million of drug product revenue compared to $14.3 million during the second quarter of 2023. The performance of roxadustat in the Astellas territories has continuously been weaker than expected. We continue to assess the impact of future forecasted net sales performance and associated royalties to FibroGen, which we anticipate will lower the future projected cash inflows related to Astellas territories.

2024 年第二季度，我們的藥品收入為 70 萬美元，而 2023 年第二季為 1,430 萬美元。羅沙司他在安斯泰來地區的表現持續低於預期。我們繼續評估未來預測的淨銷售業績和 FibroGen 相關特許權使用費的影響，我們預計這將降低與安斯泰來地區相關的未來預計現金流入。

I will now move to provide further detail on our financial performance in China. Total roxadustat net sales from the joint distribution entity or JDE owned by AstraZeneca and FibroGen and direct to distributor sales from FibroGen was $92.3 million this quarter compared to $76.4 million in the second quarter of 2023, an increase of 21% year over year.

我現在將進一步詳細介紹我們在中國的財務表現。本季來自阿斯特捷利康和FibroGen 擁有的聯合分銷實體或JDE 的roxadustat 淨銷售額以及FibroGen 直接向分銷商的銷售額總額為9230 萬美元，而2023 年第二季度為7640 萬美元，同比增長21% 。

This growth has enabled us to achieve and maintain a brand value share of 46% in the category in China. From total roxadustat net sales in China, FibroGen's net transfer price from sales to the JDE was $28 million this quarter compared to $23.8 million in the second quarter of 2023, an increase of 18% year over year. Net (technical difficulty) best reflection of FibroGen's portion of the cash received from roxadustat in China.

這一成長使我們能夠在中國該類別中實現並維持 46% 的品牌價值份額。從roxadustat在中國的總淨銷售額來看，FibroGen本季向JDE的銷售淨轉讓價格為2,800萬美元，而2023年第二季為2,380萬美元，較去年同期成長18%。淨值（技術難度）最好反映 FibroGen 從 roxadustat 在中國收到的現金部分。

During this quarter, as I stated earlier, we also released $18 million from deferred revenue due primarily to changes in forward-looking expectations for roxadustat in China. As a result, FibroGen recorded $46 million in net revenue for the quarter from roxadustat sales to the JDE and $3.6 million of direct-to-distributor sales for FibroGen China, totaling $49.6 million on a US GAAP basis.

正如我之前所說，在本季度，我們還從遞延收入中釋放了 1800 萬美元，這主要是由於羅沙司他在中國的前瞻性預期發生了變化。因此，FibroGen 本季透過向 JDE 銷售 roxadustat 獲得淨收入 4,600 萬美元，向 FibroGen 中國直接向經銷商銷售 360 萬美元，按照美國公認會計準則計算，淨收入總計 4,960 萬美元。

Our revenue growth highlights the continued robustness in execution and physician and patient adoption of roxadustat in China. For full year 2024, four-year models, we are raising our forecast for FibroGen China net product revenue to be between $135 million to $150 million on a US GAAP basis, which assumes a forecast of roxadustat net sales in China to range from $320 million to $350 million.

我們的收入成長凸顯了羅沙司他在中國的持續穩健執行以及醫生和患者的採用。對於2024 年全年（四年模型），我們將按美國公認會計準則計算的FibroGen 中國產品淨收入預測上調至1.35 億美元至1.5 億美元之間，其中假設roxadustat 在中國的淨銷售額預測為3.2億美元至 3.5 億美元。

Now moving down the income statement. Operating costs and expenses for the second quarter of 2024 were $61.6 million compared to $132.4 million for the second quarter of 2023, a decrease of $70.8 million or 53% year over year. Operating expenses for the quarter came in below our guidance range of $70 million to $80 million, a reflection of our continuous drive on disciplined spend showcased in our second quarter results.

現在將損益表向下移動。2024 年第二季的營運成本和費用為 6,160 萬美元，而 2023 年第二季為 1.324 億美元，年減 7,080 萬美元，即 53%。本季的營運支出低於我們 7,000 萬美元至 8,000 萬美元的指導範圍，這反映了我們在第二季業績中展現的持續推動嚴格支出的情況。

R&D expenses for the second quarter of 2024 were $34.1 million compared to $95.5 million in the second quarter of 2023, a decrease of 64% or $61.4 million year-over-year, primarily reflecting reductions in pamrevlumab, clinical trial spend, R&D infrastructure and one-time Fortis acquisition expenses.

2024 年第二季的研發費用為 3,410 萬美元，而 2023 年第二季為 9,550 萬美元，年減 64%，即 6,140 萬美元，主要反映了 pamrevlumab、臨床試驗支出、研發基礎設施和- 時富通收購費用。

Of our $34.1 million of R&D expenses, approximately 58% was related to pamrevlumab, 18% directed to FG-3246, 18% to support our immuno-oncology pipeline assets, with the remaining 5% directed towards roxadustat development activities. We expect our pamrevlumab and immuno-oncology R&D expenses to decline significantly in the second half of the year.

在我們 3,410 萬美元的研發費用中，約 58% 與 pamrevlumab 相關，18% 用於 FG-3246，18% 用於支持我們的免疫腫瘤管道資產，其餘 5% 用於 roxadustat 開發活動。我們預計下半年 pamrevlumab 和免疫腫瘤學研發費用將大幅下降。

SG&A expenses for the second quarter of 2024 were $22.3 million compared to $31.2 million in the second quarter of 2023, a decrease of 29% or $8.9 million year over year, primarily driven by the company's cost reduction efforts resulting in a leaner SG&A infrastructure. Finally, cost of goods sold for the second quarter of 2024 was $5.2 million compared to $5.7 million for the second quarter of 2023.

2024 年第二季的SG&A 費用為2,230 萬美元，而2023 年第二季為3,120 萬美元，年減29%，即890 萬美元，這主要是由於公司降低成本的努力導致了SG&A 基礎設施的精簡。最後，2024 年第二季的銷售成本為 520 萬美元，而 2023 年第二季為 570 萬美元。

During the second quarter of 2024, we recorded a net loss of $15.5 million or $0.16 net loss for both basic and diluted share as compared to a net loss of $87.7 million or [$0.90] per basic and diluted share for the second quarter of 2023.

2024 年第二季度，我們錄得淨虧損 1,550 萬美元，基本股和稀釋股淨虧損 0.16 美元，而 2023 年第二季淨虧損 8,770 萬美元，基本股和稀釋股淨虧損 0.90 美元。

Given the recent negative pamrevlumab outcome, we are winding down any remaining obligations related to pamrevlumab and our immuno-oncology assets during the second half of 2024. We have also announced a reduction in our US workforce of approximately 75%.

鑑於最近 pamrevlumab 的負面結果，我們將在 2024 年下半年減少與 pamrevlumab 和我們的免疫腫瘤資產相關的任何剩餘義務。我們也宣布將美國員工人數減少約 75%。

With this backdrop and excluding any restructuring charges in the third or fourth quarter, we expect our total operating expenses including cost of goods sold in the third and fourth quarter to be between $45 million and $55 million per quarter with the third quarter estimated to be at the higher end and the fourth quarter estimated to be at the lower end of this range.

在此背景下，不包括第三季或第四季的任何重組費用，我們預計第三季和第四季的總營運費用（包括銷售成本）將在每季4,500 萬美元至5,500 萬美元之間，其中第三季度預計為預計第四季度處於該範圍的高端，而第四季度則處於該範圍的低端。

Now shifting towards cash. As of June 30, we reported $147.1 million in cash, cash equivalents and accounts receivable. It is important to spend a few moments highlighting the changes in our cash balance. Our cash burn in the second quarter reflects a true-up payment to Astellas of $35.3 million.

現在轉向現金。截至 6 月 30 日，我們報告的現金、現金等價物和應收帳款為 1.471 億美元。花一些時間強調我們現金餘額的變化非常重要。我們第二季的現金消耗反映了向安斯泰來支付的 3,530 萬美元的真實款項。

We expect any future true-up payments to be significantly lower moving forward as Astellas has reduced their future orders of roxadustat to reflect slower than anticipated launch in their territories.

我們預計未來的任何實際付款將顯著降低，因為安斯泰來減少了羅沙司他未來的訂單，以反映在其地區的上市速度慢於預期。

Additionally, we also had a one-time inventory settlement payment of $11.5 million to AstraZeneca in the quarter due to the termination of our US rest of world agreement. Excluding these cash outflows, our net operating cash burn was $20.8 million in the second quarter.

此外，由於我們與美國和世界其他地區的協議終止，本季我們也向阿斯特捷利康支付了 1,150 萬美元的一次性庫存結算款項。排除這些現金流出，我們第二季的淨營運現金消耗為 2,080 萬美元。

We expect our second half 2024 quarterly net operating cash burn to be lower than what we experienced in the second quarter. We believe that the focus towards cost reduction and cash maximization initiatives will enable us to continue to pursue our strategic direction.

我們預計 2024 年下半年季度淨營運現金消耗將低於第二季的水平。我們相信，專注於降低成本和現金最大化措施將使我們能夠繼續追求我們的策略方向。

Finally, and as we have continually communicated, we expect our cash, cash equivalents and accounts receivable to fund our operating plans into 2026.

最後，正如我們不斷溝通的那樣，我們預計我們的現金、現金等價物和應收帳款將為我們到 2026 年的營運計劃提供資金。

Thank you. And now I will turn the call back over to Thane.

謝謝。現在我將把電話轉回塔恩。

Thank you, Juan. In closing, we remain excited about the company's prospects and the potential value they provide to stakeholders. Roxadustat continue to perform very well in China where we expect an approval decision of our sNDA for the chemotherapy-induced anemia indication in the second half of this year and our partner Astellas continues with the commercialization of roxadustat in Europe, Japan and other markets.

謝謝你，胡安。最後，我們對公司的前景及其為利害關係人提供的潛在價值仍然感到興奮。Roxadustat 在中國繼續表現良好，我們預計今年下半年我們的 sNDA 將批准化療引起的貧血適應症，我們的合作夥伴安斯泰來將繼續在歐洲、日本和其他市場進行 roxadustat 的商業化。

Additionally, given that we regain rights for roxadustat for US ROW territories from AstraZeneca, we are actively exploring potential partnering opportunities in anemia in patients with lower risk MDS.

此外，鑑於我們從阿斯特捷利康重新獲得了羅沙司他在美國 ROW 地區的權利，我們正在積極探索低風險 MDS 患者貧血方面的潛在合作機會。

With regards to FG-3246 and PET46, we recently reported compelling top line data from the Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer and we'll publish the totality of the Phase 1 data in an upcoming manuscript.

關於FG-3246 和PET46，我們最近報告了FG-3246 在轉移性去勢抵抗性前列腺癌中的1 期單藥治療研究中令人信服的頂線數據，我們將在即將發布的手稿中發布1期數據的全部數據。

We have also presented compelling preliminary top line data from the dose escalation Phase 1b study of FG-3246 in combination with enzalutamide in mCRPC at the 2024 ASCO Annual Meeting in June. We anticipate initiation of our Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in the first quarter of 2025 and we anticipate topline results from the Phase 2 portion of the combination study in the first half of 2025.

我們也在 6 月舉行的 2024 年 ASCO 年會上展示了 FG-3246 合併恩雜魯胺治療 mCRPC 的劑量遞增 1b 期研究令人信服的初步頂線數據。我們預計將於 2025 年第一季啟動 FG-3246 治療 mCRPC 的 2 期單藥劑量優化研究，並預計聯合研究的 2 期部分將在 2025 年上半年獲得頂線結果。

As we stated earlier in the call, we will initiate partnership discussions for our two early-stage immuno-oncology assets FG-3165 and FG-3175 with the aim of ensuring their continued development and providing FibroGen with potential access to non-dilutive capital. Finally, we have a strong balance sheet and expect our current cash position as Juan said to fund operations into 2026.

正如我們之前在電話會議中所說，我們將為我們的兩種早期免疫腫瘤資產FG-3165 和FG-3175 啟動合作夥伴討論，目的是確保它們的持續發展，並為FibroGen 提供獲得非稀釋資本的潛在機會。最後，我們擁有強大的資產負債表，並預期我們目前的現金狀況（正如胡安所說）將為 2026 年的營運提供資金。

In summary, we have made some very difficult but necessary decisions based upon the outcomes of our two late stage pamrevlumab trials in pancreatic cancer. We believe these decisions best position FibroGen to successfully execute against our updated strategic priorities as we strive to attain a valuation that we believe is more reflective of our current and future roxadustat revenue streams, first-in-class ADC and companion PET imaging agent and our strong balance sheet.

總之，我們根據兩項胰臟癌晚期 pamrevlumab 試驗的結果做出了一些非常困難但必要的決定。我們相信，這些決定最有利於FibroGen 成功執行我們更新的戰略重點，因為我們努力獲得估值，我們相信該估值更能反映我們當前和未來的roxadustat 收入流、一流的ADC 和配套PET 顯影劑以及我們的強勁的資產負債表。

I would like to thank all of the employees of FibroGen for their continued hard work and perseverance over the last few months.

我要感謝 FibroGen 的所有員工在過去幾個月的持續努力和堅持。

I would now like to turn the call over to the operator for Q&A.

我現在想將電話轉給接線員進行問答。

(Operator Instructions) Andy Hsieh, William Blair.

（操作員說明）Andy Hsieh，William Blair。

This is Dalton Greenwood on for Andy Hsieh. Thank you for taking our questions. Given the singular focus on FG-3246 now do you have any plans on accelerating its development just to maximize the asset's value for shareholders?

我是道爾頓·格林伍德 (Dalton Greenwood) 替安迪·謝 (Andy Hsieh) 發言。感謝您接受我們的提問。鑑於現在對 FG-3246 的單一關注，您是否有計劃加速其開發，以最大限度地提高股東的資產價值？

In parallel, you have a very robust China business based on the strength of roxadustat's clinical profile. Could you comment on the liquidity of cash generated in China? In other words how do you as US entity access the cash derived from roxadustat revenue? Thank you.

同時，基於羅沙司他臨床概況的優勢，您在中國的業務非常強勁。您能否評論一下中國產生的現金的流動性？換句話說，作為美國實體，您如何獲得從羅沙司他收入中獲得的現金？謝謝。

Hey, Dalton. This is Thane. Thanks for your questions. I'll touch on the 3246 question and then I'll ask Juan to touch on the question about the liquidity of cash from our China operations. And obviously, Chris Chung is here as well to complement Juan if needed.

嘿，道爾頓。這是塔恩。感謝您的提問。我將談談 3246 問題，然後我將請胡安談談有關我們中國業務的現金流動性的問題。顯然，如果需要的話，克里斯·鐘也會在這裡補充胡安的不足。

As it relates to 3246, it is always been a priority asset for us since we acquired it from Fortis in May of last year. We just didn't highlight it to the extent that we highlighted pamrevlumab just because of the proximity of the catalyst for pamrevlumab from that time. And so, it has been and will continue to be an asset that we will try to prosecute with speed because that's the name of the game in our business is quality and speed.

由於它與 3246 相關，自從我們去年 5 月從富通收購它以來，它一直是我們的優先資產。我們只是沒有像強調 pamrevlumab 那樣強調它，只是因為當時 pamrevlumab 的催化劑很接近。因此，它已經並將繼續成為我們將努力加快速度的資產，因為我們業務的遊戲名稱是品質和速度。

We have an important interaction coming up with the FDA this quarter which will help inform the design of the Phase 2 trial and we would expect then to be able to plan on the initiation of the Phase 2 program after that point in time. So yeah, we are prosecuting it as quickly as we can.

本季度我們將與 FDA 進行重要的互動，這將有助於為第二階段試驗的設計提供信息，我們希望能夠在該時間點之後計劃啟動第二階段計劃。所以，是的，我們正在盡快起訴它。

Yeah, Dalton. And with regards to your second question, this is Juan. With regards to the cash in China and cash generation in China, over the course of the last year or so, we have been repatriating cash from China based on a facility that we had set up as registered debt with our China operations.

是的，道爾頓。關於你的第二個問題，我是胡安。關於中國的現金和中國的現金生成，在過去一年左右的時間裡，我們一直根據我們在中國業務中作為登記債務設立的一項安排，從中國匯回現金。

We will continue on that front. And beyond that, we are also exploring other facilities, other avenues to continue to repatriate cash from China. So those are I think some of the elements that we're continuously evaluating to bring money back to the US.

我們將繼續這方面的工作。除此之外，我們也正在探索其他設施、其他途徑，以繼續從中國匯回現金。所以我認為這些是我們不斷評估的一些因素，以便將資金帶回美國。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hi. This is Dina Ramadane on for Jason Gerberry. I just had two questions from us. The first is I guess on expected timeline of how soon you could look to partner your two preclinical candidates? How early could you begin to have those discussions?

你好。我是賈森·傑伯里 (Jason Gerberry) 的迪娜·拉瑪丹 (Dina Ramadane)。我剛剛收到我們的兩個問題。第一個是我猜想您多久可以與兩位臨床前候選人合作的預期時間表？您可以多久開始進行這些討論？

Is it kind of fair to assume that you'd look to generate some Phase 1 data beforehand? Or would that be on the back of more of like a preclinical data? And then I have one follow-up.

假設您希望事先產生一些第一階段數據，這公平嗎？或者這會更依賴臨床前數據嗎？然後我有一個後續行動。

Thanks, Dina, for the question. So the data package that we would have to showcase to potential interested parties will be a preclinical data set. Clearly, for the anti-galectin-9 antibody, it's a very extensive data set because of the fact that we had -- recently had the IND cleared.

謝謝迪娜提出問題。因此，我們必須向潛在感興趣的各方展示的資料包將是臨床前資料集。顯然，對於抗半乳糖凝集素 9 抗體來說，這是一個非常廣泛的數據集，因為我們最近已經獲得了 IND 批准。

And so, we believe there's sufficient information there for potential partners to be able to make the determination of what the path forward could mean and the potential value to them.

因此，我們相信潛在的合作夥伴有足夠的資訊來確定前進的道路意味著什麼以及對他們的潛在價值。

For CCR8, we had previously stated that we expected to file an IND sometime in the 2025 timeframe. And so, we've done as I've said in the opening comments, we've done quite a lot of work on affinity maturation, specificity potency and feel like as we compare our antibody to other antibodies, other CCR8s, especially when compare them and SAR comparisons and things of that nature that, we feel very, very good about the optimization work that our team has done on the CCR8 antibody.

對於 CCR8，我們之前曾表示，我們預計將在 2025 年的某個時間提交 IND。因此，正如我在開場評論中所說，我們在親和力成熟、特異性效力方面做了相當多的工作，並且當我們將我們的抗體與其他抗體、其他 CCR8 進行比較時，尤其是在比較時通過它們和SAR 比較以及類似性質的事情，我們對我們的團隊在CCR8 抗體上所做的優化工作感到非常非常滿意。

And so, that would be information that a potential partner would have access to as well. And just to maybe reiterate, there's really a couple of different dynamics in play with these two particular targets. There's only one other anti-Gal9 antibody in the clinic that's from Gallop Oncology which is a PureTech spin-off.

因此，潛在合作夥伴也可以存取這些資訊。也許需要重申一下，這兩個特定目標確實存在一些不同的動態。診所中只有一種來自 Gallop Oncology 的抗 Gal9 抗體，該公司是 PureTech 的衍生公司。

And so, we think we're in a really good position from a timing perspective with our Gal9 antibody. And then with the CCR8 category, while we aren't in a favorable a competitive position, it is an incredibly hot space right now.

因此，我們認為從時間角度來看，我們的 Gal9 抗體處於非常有利的位置。然後是 CCR8 類別，雖然我們沒有處於有利的競爭地位，但現在它是一個非常熱門的領域。

As I'm sure you're aware, there's a lot of activity and it seems like there's emerging excitement about the mechanism as well. So we feel good about the ability to partner both of these assets and we're going to start those activities immediately.

我相信您也知道，有很多活動，而且似乎人們對機制也越來越感到興奮。因此，我們對與這兩種資產合作的能力感到滿意，我們將立即開始這些活動。

And then one more follow-up for me here. Just what's the nature of the update we can expect from the top-line data of FG-3246's combo trial with enzalutamide? Just in terms of patients -- number of patients and duration of follow-up that we could expect to see?

然後我在這裡再做一個後續行動。我們可以從 FG-3246 與恩雜魯胺聯合試驗的主要數據中期待更新的本質是什麼？就患者而言－我們期望看到的患者數量和追蹤持續時間？

And then wondering if you could please maybe set a bar that you would consider clinically meaningful on the PFS benefit that you'd like to see to confirm the durability of response that we saw at the prior data cut. Thank you.

然後想知道您是否可以設定一個您認為對 PFS 益處具有臨床意義的標準，您希望看到該標準，以確認我們在先前的資料削減中看到的反應的持久性。謝謝。

No, that's a really good question, Dina. I'll turn it over to Deyaa to answer that one and then I'll follow-up if needed. Deyaa, do you want to take that one?

不，這是一個非常好的問題，迪娜。我會將其轉交給 Deyaa 來回答這個問題，然後如果需要的話我會跟進。Deyaa，你想拿那個嗎？

Sure. Thank you, Thane, and thank you, Dina, for this question. So the combination study at UCSF as you have seen at ASCO has already completed the Phase 1 dose escalation, and they have already started the Phase 2 expansion component after realizing the recommended Phase 2 dose.

當然。謝謝你，塔恩，也謝謝你，迪娜，提出這個問題。因此，正如您在 ASCO 看到的那樣，UCSF 的聯合研究已經完成了 1 期劑量遞增，並且在實現建議的 2 期劑量後，他們已經開始了 2 期擴展部分。

So having said that, the data that you have seen from dose escalation is very, very encouraging because of the fact that the majority of those 17 patients were post two prior ARSIs. This population is (technical difficulty) they have also failed abiraterone acetate. They don't constitute this area of PET medical needs.

話雖如此，您從劑量遞增中看到的數據非常非常令人鼓舞，因為這 17 名患者中的大多數都經歷過兩次 ARSI。這個人群（技術難度）他們醋酸阿比特龍也失敗了。它們不構成 PET 醫療需求的這一領域。

So for those patients to have 10.2 months radiographic PFS, this is very exciting. The bar for this setting, meaning after patients have failed two prior ARSIs is around six months rPFS. So as you can see the combo has already exceeded the current bar which is only six months.

因此，對於那些擁有 10.2 個月影像學 PFS 的患者來說，這是非常令人興奮的。此設定的標準，即患者先前兩次 ARSI 失敗後，rPFS 約為六個月。正如您所看到的，該組合已經超出了當前僅六個月的標準。

In terms of moving up the treatment line, once the (technical difficulty) more patients in the second line setting, meaning patients who have completed only one prior ARSI, we are going to see potentially much higher rPFS and in this case, the comparison will be somewhere between 18 to 20 months.

就提升治療線而言，一旦（技術難度）有更多患者進入二線治療，即先前僅完成一次 ARSI 的患者，我們將看到潛在更高的 rPFS，在這種情況下，比較將大約在18 到20 個月之間。

This is the current bar with abiraterone acetate and enzalutamide in the first -- strictly first line setting. So this is the current landscape, and we are hoping that in the Q1 of or I mean first half of next year, we will be able to publish the top-line results from the combination having a total of 36 patients in the study. So it will be a robust data set to give us a meaningful signal of clinical activity in either line second line or first line setting.

這是目前第一款含有醋酸阿比特龍和恩雜魯胺的皂條——嚴格的一線設定。這就是目前的情況，我們希望在明年第一季度，或者我的意思是明年上半年，我們將能夠發布該研究中總共 36 名患者的組合的主要結果。因此，這將是一個強大的數據集，可以為我們提供有意義的二線或第一線臨床活動訊號。

Thanks, Deyaa. That was excellent. Dina, one thing that I would add is that these additional patients that are being enrolled now as part of the expansion cohort will also have PET imaging data as well. So that's in addition to a more mature rPFS that Deyaa spoke to. We'll also begin to see some information and be able to characterize CD46 expression and potential response as well. Small numbers, but it will be an important additional data point for us.

謝謝，德亞。那太好了。迪娜，我要補充的一件事是，現在作為擴展隊列的一部分而入組的這些額外患者也將擁有 PET 成像數據。這是 Deyaa 談到的更成熟的 rPFS 的補充。我們也將開始看到一些資訊並能夠表徵 CD46 表達和潛在反應。雖然數字雖小，但對我們來說將是一個重要的附加數據點。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Hi. Good afternoon. Thank you for taking our question. My first question is on the updated guidance. And can you maybe comment on how much of this may be driven by a potential raise in guidance -- maybe driven by potential approval of a CIA indication versus continued volume growth from the CKD indication?

你好。午安.感謝您提出我們的問題。我的第一個問題是關於更新後的指南。您能否評論一下其中有多少可能是由指導的潛在提高所驅動的——可能是由 CIA 適應症的潛在批准與 CKD 適應症的持續銷售增長所驅動的？

And then my second question is I believe in July a generic roxadustat was approved. Curious if you are starting to see it in the marketplace there yet? And just what your thoughts are on the pricing impact? I think you had about a 12% headwind from pricing on your volume, offsetting your volume this quarter. So any updated thoughts on the pricing impact from the competitive launch would be appreciated.

我的第二個問題是，我相信 7 月仿製藥 roxadustat 已獲得批准。好奇您是否已經開始在市場上看到它了嗎？您對定價影響有何看法？我認為您的銷售定價受到了大約 12% 的阻力，抵消了本季的銷售量。因此，任何有關競爭性發布對定價影響的最新想法將不勝感激。

Yeah. Thanks Paul. It's Thane. I'll go ahead and start and then I'm going to turn it over to Chris as well. In terms of the underlying performance of roxadustat in China and the raise of the guidance, it's 100% due to continued strong performance by the team in the anemia CKD indication in that indication by itself. There's no pre-ordering in anticipation of a CIA approval or anything like that. So it's all just inherent strong underlying demand.

是的。謝謝保羅。是泰恩。我會繼續開始，然後我也會把它交給克里斯。就羅沙司他在中國的基本表現和指導意見的上調而言，100%是由於該團隊在貧血CKD適應症本身的持續強勁表現。沒有等待中央情報局批准或類似的事情的預購。所以這只是固有的強大的潛在需求。

In terms of the generic entrants, as we said in our opening remarks, there have been two generics that are approved. This walk down from 33% volume growth to 31% to 21% revenue growth. There was a 7% price reduction as part of the VBP renewal at the end of last year. And so, there's not a 12% price headwind. There was a 7% price headwind.

就彷製藥進入者而言，正如我們在開場白中所說，已有兩種仿製藥獲得批准。這使得銷量成長率從 33% 下降到 31% 至 21% 的收入成長率。去年年底，作為 VBP 續訂的一部分，價格降低了 7%。因此，不存在 12% 的價格逆風。價格出現了 7% 的逆風。

And then the expected pricing will really be dependent upon what happens if and when the government calls for VBP for roxadustat to be included in VBP. Let me ask Chris to add some additional color given her intimate knowledge of the environment there.

然後，預期定價實際上將取決於如果政府要求將羅沙司他的 VBP 納入 VBP 時會發生什麼。鑑於克里斯對當地環境的深入了解，讓我請她添加一些額外的色彩。

Yeah. Thank you, Thane. So Paul, we have not seen the launch of the generic on the market. So it's very difficult to give you a sense of market adoption. With respect to pricing, at this point in time, there are no plans to change pricing in response to generic entry until we are subject to vote.

是的。謝謝你，塔恩。所以保羅，我們還沒有看到市場上推出仿製藥。所以很難給你一種市場採用的感覺。關於定價，目前在我們進行投票之前，沒有計劃根據通用條目改變定價。

And if I could squeeze in one pipeline question please just on 3246 to follow-up on the combination data. I guess, as you think about planning that -- obviously, you'll work on the dose optimization starting next year.

如果我可以提出管道問題，請直接撥打 3246 來跟進組合資料。我想，當你考慮計劃時 - 顯然，你將從明年開始致力於劑量優化。

But as you look down the road, is there any particular population beyond the PET positive that you think might be additionally benefiting from the combination? Or will you primarily focus in terms of like increasing the probability of success, be focused primarily on the PET positive population?

但是，當您展望未來時，您認為除了 PET 陽性之外，是否還有任何特定人群可能會從該組合中額外受益？或者您會主要專注於增加成功的可能性，主要關注 PET 陽性人群嗎？

Yeah. So, I'll start off and then Deyaa, I'm going to turn it over to you. So really what we're going to be exploring in the Phase 2, Paul, is with the PET is trying to understand if there is a correlation between CD46 expression in response to the drug that could then allow us to enrich the Phase 3 portion of the trial.

是的。所以，我先開始，然後 Deyaa，我會把它交給你。Paul，我們在第二階段真正要探索的是，PET 試圖了解 CD46 表現與藥物反應之間是否存在相關性，這可以讓我們豐富第三階段的部分審判。

And so, we're not using it as any a diagnostic or patient selection criteria as part of the Phase 2. We're using it to understand if there is a correlation and if there is then that would really enable us to enrich the Phase 3 portion of the trial. Deyaa will go ahead and add to that, and then Paul, we'll see if that addressed your question.

因此，我們不會將其用作第二階段的任何診斷或患者選擇標準。我們用它來了解是否存在相關性，如果存在，那麼這確實能讓我們豐富試驗的第三階段部分。德亞將繼續補充這一點，然後保羅，我們將看看這是否解決了您的問題。

Yeah, Paul. So thank you for the question. I completely confirm what Thane has just mentioned. But on top of that remember that data derived from our Phase 1 study that was conducted by Fortis in addition to the current combination to UCSF with enzalutamide has all been conducted in an unselected population.

是的，保羅。謝謝你的提問。我完全證實了塔恩剛才所說的。但最重要的是，請記住，除了目前 UCSF 與恩雜魯胺的組合外，我們由 Fortis 進行的第一階段研究得出的數據都是在未經選擇的人群中進行的。

So that is very true. Our primary focus will be to enhance the opportunity for patients to derive clinical benefit by pre-selecting them with PET46. But when we talk to our KOLs, they also tell us that there could be another opportunity in all-comers if the data continue to show robustness and strong signal of rPFS.

所以這是非常正確的。我們的主要重點是透過 PET46 預先選擇患者，增加患者獲得臨床效益的機會。但當我們與 KOL 交談時，他們也告訴我們，如果數據繼續顯示 rPFS 的穩健性和強烈信號，那麼所有人都可能有另一個機會。

So this is like not something that we will abandon, but it is going to be another opportunity in all-comers as long as we continue to see very strong data. But the primary focus will be PET46 pre-selection.

因此，這並不是我們會放棄的事情，但只要我們繼續看到非常強勁的數據，這將是所有人的另一個機會。但主要焦點將是 PET46 預選。

Guys, we still have a few more minutes. So Dalton, Dina, Paul, if you have any additional questions?

夥計們，我們還有幾分鐘。道爾頓、迪娜、保羅，你們還有其他問題嗎？

There appear to be no further questions in the queue. So this will conclude our question-and-answer session. I would like to turn the conference back over to Thane Wettig for any closing remarks.

隊列中似乎沒有其他問題了。我們的問答環節到此結束。我想將會議轉回塔恩·韋蒂格（Thane Wettig）發表閉幕詞。

No. Thank you and we really appreciate the participation in today's call and your interest in FibroGen. Enjoy the rest of your day. Thanks, guys.

不。謝謝您，我們非常感謝您參加今天的電話會議以及您對 FibroGen 的興趣。享受你一天剩下的時間。謝謝，夥計們。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。