FibroGen Inc (FGEN) 2021 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the FibroGen Second Quarter 2021 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

美好的一天，感謝您的支持。歡迎參加 FibroGen 2021 年第二季財務業績電話會議。 （操作員說明）謹此提醒，本次電話會議正在錄音。

I would now like to turn the call over to Mr. Michael Tung. Please go ahead.

我現在想把電話轉給董先生。請繼續。

Thank you, Charlie. Good afternoon everyone, and welcome to FibroGen's 2021 Second Quarter Conference Call. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen.

謝謝你，查理。大家下午好，歡迎參加 FibroGen 2021 年第二季電話會議。我是 Michael Tung，FibroGen 企業策略與投資者關係副總裁。

Joining me on today's call are Enrique Conterno, our Chief Executive Officer; Pat Cotroneo, our Chief Financial Officer; Dr. Mark Eisner, our Chief Medical Officer; Dr. John Hunter, our Chief Scientific Officer; Thane Wettig, our Chief Commercial Officer; and Chris Chung, our Senior Vice President of China Operations.

參加今天電話會議的還有我們的執行長 Enrique Conterno； Pat Cotroneo，我們的財務長；我們的首席醫療官 Mark Eisner 博士；約翰‧亨特博士，我們的首席科學官； Thane Wettig，我們的首席商務官；以及我們中國業務資深副總裁 Chris Chung。

The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A.

今天電話會議的格式包括恩里克和帕特準備好的發言，之後我們將開始問答電話會議。

I would like to remind you that remarks made on today's call may include forward-looking statements based on FibroGen's current expectations. Such statements may include statements regarding to, but not limited to, our research and development activities; the initiation, enrollment, design, conduct and results of clinical trials; our regulatory strategies and potential regulatory results; anticipated FDA interactions; commercialization and results of operations; risks, plans, market opportunity and strategy related to our business; our collaborations with AstraZeneca and Astellas; financial guidance; and certain other business matters. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those anticipated in such statements. For a discussion of these and other material risks and factors that could affect our future financial results and business, please refer to the disclosure in today's press release reporting our fiscal 2021 second quarter financial results and business update, our most recent Forms 10-K and 10-Q and reports that we may file on Form 8-K with the Securities and Exchange Commission. All our statements are made as of today, August 9, 2021, based on information currently available to us, and FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

我想提醒您，今天電話會議上的言論可能包括基於 FibroGen 目前預期的前瞻性陳述。此類聲明可能包括有關但不限於我們的研發活動的聲明；臨床試驗的啟動、招募、設計、實施和結果；我們的監管策略和潛在的監管結果；預期的 FDA 交互作用；商業化及經營成果；與我們業務相關的風險、計劃、市場機會和策略；我們與阿斯特捷利康和安斯泰來的合作；財務指導；以及某些其他業務事宜。此類前瞻性陳述存在重大風險和不確定性，可能導致實際結果與此類陳述中的預期有重大差異。有關可能影響我們未來財務業績和業務的這些及其他重大風險和因素的討論，請參閱今天的新聞稿中披露的內容，其中報告了我們2021 財年第二季度財務業績和業務更新、我們最新的10-K 表格和10-Q 以及我們可能以 8-K 表格向美國證券交易委員會提交的報告。我們的所有聲明均基於我們目前掌握的信息，於今天（2021 年 8 月 9 日）作出，FibroGen 不承擔公開更新任何前瞻性聲明的義務，無論是由於新信息、未來事件還是其他原因，法律要求的除外。

Today's press release reporting our fiscal 2021 second quarter financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com.

今天的新聞稿報告了我們 2021 財年第二季度的財務業績和業務更新，以及今天電話會議的網路廣播，可以在 FibroGen 網站 www.fibrogen.com 的投資者部分找到。

With that, I would like to turn the call over to Enrique Conterno, our CEO. Enrique?

說到這裡，我想將電話轉給我們的執行長 Ennrique Conterno。恩里克？

Thank you, Mike, and good afternoon everyone, and welcome to our second quarter 2021 earnings call. Today, I would like to provide a high-level summary of important accomplishments and developments in recent months. Pat Cotroneo, our CFO, will then review the financials, after which, we will open up the call for your questions.

謝謝麥克，大家下午好，歡迎參加我們的 2021 年第二季財報電話會議。今天，我想對近幾個月來的重要成就和發展進行高度總結。我們的財務長 Pat Cotroneo 隨後將審查財務狀況，之後我們將開啟電話詢問您的問題。

There is no question we are facing a significant challenge given the recent FDA Advisory Committee vote. However, FibroGen continues to be positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on Slide 3: number one, ensuring regulatory and commercial success of roxadustat, a transformational medicine for the treatment of anemia, first in patients with chronic kidney disease and also with significant potential for expansion to treatment of additional indications; number two, developing pamrevlumab in three indications with significant unmet medical need, locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy and idiopathic pulmonary fibrosis; and number three, strengthening research productivity by leveraging our leadership position both in hypoxia-inducible factor and connective tissue growth factor biology and by accessing external innovation.

毫無疑問，鑑於 FDA 諮詢委員會最近的投票，我們面臨重大挑戰。然而，FibroGen 繼續致力於透過執行幻燈片 3 所示的三個重點領域為患者和股東創造重大價值：第一，確保 roxadustat（一種治療貧血的轉化藥物）在監管和商業上取得成功，首先適用於慢性腎臟病患者，並且具有擴展到其他適應症治療的巨大潛力；第二，開發pamrevlumab用於三種未滿足醫療需求的適應症：局部晚期不可切除的胰臟癌、杜氏肌肉營養不良症和特發性肺纖維化；第三，利用我們在缺氧誘導因子和結締組織生長因子生物學方面的領導地位以及獲得外部創新來提高研究生產力。

Today's call will include an update of the regulatory status of roxadustat, our continued strong performance in China, our clinical trial programs and recent corporate developments.

今天的電話會議將包括羅沙司他監管狀況的最新情況、我們在中國持續強勁的業績、我們的臨床試驗項目和最近的公司發展。

Let us get started with roxadustat on Slide 4. In June, the CHMP of the European Medicines Agency adopted a positive opinion relating to the use of roxadustat for the treatment of anemia associated with CKD. We expect a decision from the European Commission by the end of August. In July, the FDA Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving roxadustat for the treatment of anemia of CKD. We and our partner, AstraZeneca, are in dialogue with the FDA and expect an action in the near future. During the quarter, roxadustat was approved in South Korea to treat adult patients with anemia of CKD, and we have regulatory submissions in other territories under review.

讓我們從幻燈片 4 上的羅沙司他開始。6 月，歐洲藥品管理局 CHMP 通過了關於使用羅沙司他治療 CKD 相關貧血的積極意見。我們預計歐盟委員會將在八月底做出決定。 7 月，FDA 心血管和腎臟藥物諮詢委員會投票建議不批准羅沙司他用於治療 CKD 貧血。我們和我們的合作夥伴阿斯特捷利康正在與 FDA 進行對話，並期望在不久的將來採取行動。本季度，羅沙司他在韓國獲得批准用於治療成年 CKD 貧血患者，我們正在審查其他地區的監管提交文件。

To support commercialization efforts worldwide, we have submitted manuscripts covering all primary Phase 3 studies to peer-reviewed journals. As noted in Slide 5, 7 of these manuscripts have been published, encompassing both non-dialysis-dependent and dialysis-dependent data, and we expect additional publications of the Phase 3 data in the coming months.

為了支持全球商業化工作，我們已向同行評審期刊提交了涵蓋所有主要第 3 階段研究的手稿。如投影片 5 所示，其中 7 篇手稿已發表，涵蓋非透析依賴型和透析依賴型數據，我們預計在未來幾個月內將發布更多 3 期數據。

Moving now to China. As you can see on Slide 6, we are pleased to report total roxadustat net sales to distributors in China of $52.8 million for the second quarter and $96.3 million for the first half of 2021. The increase in uptake continues to be driven by both an expansion in hospital listings and broad adoption with enlisted hospitals. FibroGen reported $13.4 million in China roxadustat net product revenue for the second quarter 2021 and $28.7 million for the first half of 2021. Hospital listings continue to be a key focus of our launch efforts, and at the end of the second quarter, roxadustat was listed at hospitals that collectively represent approximately 81% of the CKD anemia market opportunity in China.

現在搬到中國。正如您在幻燈片 6 中看到的，我們很高興地報告 2021 年第二季度羅沙司他向中國經銷商的淨銷售額總額為 5280 萬美元，上半年為 9630 萬美元。醫院列表和入伍醫院的廣泛採用。 FibroGen 公佈的2021 年第二季中國羅沙司他產品淨收入為1,340 萬美元，2021 年上半年為2,870 萬美元。醫院上市仍是我們上市工作的重點，在第二季末，羅沙司他上市這些醫院合計約佔中國 CKD 貧血市場機會的 81%。

As you can see on Slide 7, the ESA market growth has accelerated since the inclusion of roxadustat on the NRDL. In fact, ESA revenue over the last 6 months has shown meaningful growth over the same period in the prior year.

正如您在幻燈片 7 中看到的，自從羅沙司他納入國家醫療保健目錄以來，ESA 市場成長加速。事實上，過去 6 個月的 ESA 收入較上年同期顯著成長。

Moving to Slide 8. Roxadustat has driven the expansion of the anemia of CKD category over the past year and a half. In fact, roxadustat captured 70% of the category growth and is capturing share in an expanding market.

轉向幻燈片 8。在過去一年半里，Roxadustat 推動了 CKD 貧血類別的擴大。事實上，roxadustat 佔據了該類別成長的 70%，並且正在不斷擴大的市場中佔據份額。

Finally, as shown on Slide 9, roxadustat is the number 1 branded treatment for anemia of CKD in China for the past 5 months, achieving a value share of 32% in the most recent month within the segment that includes all ESA products, and roxadustat, currently the only HIF-PHI in the market. We look forward to keeping you updated as we advance our long-term goal of making roxadustat the standard-of-care in treating China's CKD anemia patients.

最後，如幻燈片9 所示，羅沙司他是過去5 個月中國排名第一的CKD 貧血品牌治療藥物，最近一個月在包含所有ESA 產品的細分市場中實現了32% 的價值份額，羅沙司他，目前市面上唯一的HIF-PHI。我們期待向您通報最新情況，以推進我們的長期目標，即使羅沙司他成為治療中國 CKD 貧血患者的標準療法。

Moving now to our clinical development programs on Slide 10, COVID continues to create challenges to recruitment, and today, we are updating our timelines, starting with roxadustat. We recently completed WHITNEY, our Phase II trial in patients with chemotherapy-induced anemia, and look forward to sharing topline data with you later this quarter.

現在轉向幻燈片 10 上的臨床開發項目，新冠疫情繼續為招募帶來挑戰，今天，我們正在更新我們的時間表，從 roxadustat 開始。我們最近完成了 WHITNEY，這是我們針對化療引起的貧血患者的 II 期試驗，並期待在本季度稍後與您分享主要數據。

Topline data of MATTERHORN, our Phase 3 trial in patients with anemia of myelodysplastic syndromes, or MDS, is now expected in the second half of 2022 or first half of 2023 versus prior guidance of the first half of 2022. In China, the blinded portion of the Phase 3 trial of roxadustat in patients with anemia of MDS has begun enrollment.

MATTERHORN 是我們針對骨髓增生異常綜合症(MDS) 貧血患者進行的3 期試驗，目前預計將於2022 年下半年或2023 年上半年獲得主要數據，而之前的指導時間為2022 年上半年。在中國，盲法部分roxadustat 用於治療 MDS 貧血患者的 3 期試驗已開始入組。

Moving now to pamrevlumab. In locally advanced unresectable pancreatic cancer, an interim analysis of event free survival for potential accelerated approval of our LAPIS Phase 3 trial will be completed in the second half of 2022. Previously the resection rate was a surrogate endpoint for accelerated approval. After recent discussions with the FDA, we changed this end point to the event free survival endpoint, which is composed of progression, death and resection failure due to progression. This better reflects the potential clinical benefit in this patient population.

現在轉向 pamrevlumab。對於局部晚期不可切除的胰臟癌，我們的 LAPIS 3 期試驗可能加速核准的無事件存活期中期分析將於 2022 年下半年完成。此前，切除率是加速核准的替代終點。經過最近與 FDA 的討論，我們將此終點更改為無事件生存終點，該終點由進展、死亡和因進展導致的切除失敗組成。這更好地反映了該患者群體的潛在臨床益處。

During the second quarter, pamrevlumab was included in the Pancreatic Cancer Action Network's Precision Promise adaptive trial platform, which is evaluating pamrevlumab and standard of care for patients with metastatic pancreatic cancer.

第二季度，pamrevlumab 被納入胰臟癌行動網路的 Precision Promise 適應性試驗平台，該平台正在評估 pamrevlumab 和轉移性胰臟癌患者的護理標準。

Moving to Duchenne muscular dystrophy, enrollment continues in our LELANTOS-1 Phase 3 trial in non-ambulatory patients with topline data now expected in the first half of 2023 versus prior guidance of second half 2022.

至於杜氏肌肉營養不良症，我們的 LELANTOS-1 3 期試驗繼續在非臥床患者中進行入組，目前預計將在 2023 年上半年獲得頂線數據，而之前的指導則為 2022 年下半年。

Finally, in idiopathic pulmonary fibrosis, today we're pleased to provide guidance that we expect topline data from our ZEPHYRUS-1 Phase 3 trial in mid-2023. These timelines assume current COVID conditions, and we will provide further updates as they become available.

最後，在特發性肺纖維化方面，今天我們很高興提供指導，我們預計 ZEPHYRUS-1 3 期試驗將於 2023 年中期獲得頂線數據。這些時間表假定當前的新冠肺炎疫情狀況，我們將在有進一步更新時提供。

Moving now to the corporate update. We appointed Dr. John Hunter to the position of Chief Scientific Officer.

現在轉向公司更新。我們任命約翰·亨特博士擔任首席科學官。

Moving now to Slide 11. In June, we announced our partnership with HiFiBiO to advance next-generation therapies for patients with cancer and autoimmune disease, a deal which could enable up to three INDs by 2023. FibroGen is accessing three new monoclonal antibodies against exciting targets, Galectin-9, CXCR5 and CCR8. Galectin-9 is an oncology target with a reported role in acute myeloid leukemia and immune resistance in many solid tumors. Next, CXCR5 is an autoimmune and oncology target and our primary interest is autoimmunity, but there are also opportunities in Bcell lymphomas. Finally, CCR8 is an oncology target with broad potential in solid tumors.

現在轉到幻燈片11。6 月，我們宣布與HiFiBiO 合作，為癌症和自體免疫疾病患者推進下一代療法，這項交易可能會在2023 年之前實現多達三個IND。FibroGen 正在獲取三種新的單株抗體，以對抗令人興奮的疾病標靶：Galectin-9、CXCR5 和 CCR8。 Galectin-9 是一種腫瘤學靶點，據報導在急性髓系白血病和許多實體瘤的免疫抵抗中發揮作用。接下來，CXCR5 是一個自體免疫和腫瘤學靶點，我們的主要興趣是自體免疫，但 B 細胞淋巴瘤也有機會。最後，CCR8 是一個在實體瘤中具有廣泛潛力的腫瘤學標靶。

Now I would like to provide an update on our internal review. On April 6, 2021, the company clarified that certain previously disclosed cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia in chronic kidney disease included post-hoc changes to the stratification factors and provided additional data from the cardiovascular safety analyses with a pre-specified stratification factors. As stated at that time, the company initiated an internal review to ensure this does not occur in the future.

現在我想提供我們內部審查的最新情況。 2021年4月6日，該公司澄清，先前披露的用於治療慢性腎病貧血的roxadustat 3期項目的某些心血管安全性分析包括分層因素的事後變化，並提供了心血管安全性分析的額外資料預先指定的分層因素。正如當時所述，該公司啟動了內部審查，以確保未來不會發生這種情況。

We now have completed that review. Key company findings from the review are as follows. The underlying data used for the cardiovascular safety analyses are accurate with no data integrity issues with the data used to generate such analyses. In its NDA, the company calculated accurately and described both set of analyses, including the statistical methodologies and stratification factors utilized. The statistical analyses using post-hoc stratification factors were designated as primary analysis, and the statistical analyses using pre-specified stratification factors as a sensitivity analysis. Those responsible for the statistical analyses believed it was a reasonable and valid way to analyze and present the data.

我們現在已經完成了審查。公司審查的主要結果如下。用於心血管安全性分析的基礎數據是準確的，用於產生此類分析的數據不存在數據完整性問題。在其 NDA 中，該公司準確計算並描述了兩組分析，包括所使用的統計方法和分層因素。使用事後分層因素的統計分析被指定為主要分析，而使用預先指定的分層因素的統計分析被指定為敏感度分析。負責統計分析的人員認為這是分析和呈現數據的合理且有效的方式。

Management is taking steps to ensure the company's processes are consistent with best practices in all respects. In addition to other processes and procedures, we plan to implement independent quality unit oversight of clinical data management, programming, analysis and reporting. Furthermore, those directly responsible for the decision to use post-hoc stratification factors in the primary analysis no longer work for the company. The use of post-hoc stratification factors was not discussed by the FDA Advisory Committee or referenced as a consideration that led to the Advisory Committee vote against recommending approval for roxadustat. We do not believe that it played any role in that vote.

管理階層正在採取措施確保公司流程在各個方面都符合最佳實務。除了其他流程和程序外，我們還計劃對臨床數據管理、程式設計、分析和報告實施獨立的品質部門監督。此外，那些直接負責在主要分析中使用事後分層因素的決定的人員不再為公司工作。 FDA 諮詢委員會沒有討論事後分層因素的使用，也沒有將其作為導致諮詢委員會投票反對建議批准 roxadustat 的考慮因素。我們認為它在那次投票中沒有發揮任何作用。

I will now turn the call over to our CFO, Pat Cotroneo, for the financial update. Pat?

我現在將把電話轉給我們的財務長 Pat Cotroneo，了解最新的財務狀況。拍？

Thank you, Enrique. As announced today, total revenue for the second quarter of 2021 was $24.4 million as compared to $42.9 million for the second quarter of 2020. The current quarter revenue consists of $13.4 million net product revenue for roxadustat sales in China; $19.6 million in development revenue; and a negative $8.6 million in drug product revenue which reflects our estimate of lower potential revenue from commercial batches shipped to date to AstraZeneca in the U.S. as a result of the recent unfavorable Advisory Committee vote.

謝謝你，恩里克。正如今天宣布的那樣，2021 年第二季的總收入為2,440 萬美元，而2020 年第二季的總收入為4,290 萬美元。本季收入包括羅沙司他在中國銷售的1,340 萬美元產品淨收入； 1,960萬美元的開發收入；藥品收入為負 860 萬美元，這反映了由於最近諮詢委員會的不利投票，我們估計迄今為止運往美國阿斯特捷利康的商業批次的潛在收入較低。

For the same period, operating costs and expenses were $158.2 million and net loss was $134 million or $1.45 per basic and diluted share, as compared to operating costs and expenses of $128 million and a net loss of $85.3 million or $0.95 per basic and diluted share for the second quarter last year. Included in operating costs and expenses for the quarter ended June 30, 2021, was a one-time charge of $25 million related to our partnership with HiFiBiO and an increase of approximately $20 million, which is primarily in pamrevlumab development expenses, as compared to the second quarter last year. Operating costs and expenses for the quarter also included a non-cash charge of $19 million for stock-based compensation expense, as compared to $17.6 million for stock-based compensation expense for the same period in the prior year.

同期，營運成本和費用為1.582 億美元，淨虧損為1.34 億美元，即每股基本股和稀釋股1.45 美元，而營運成本和費用為1.28 億美元，淨虧損為8,530 萬美元，即每股基本股和稀釋股0.95 美元去年第二季。截至 2021 年 6 月 30 日的季度營運成本和費用中包括與我們與 HiFiBiO 合作相關的一次性費用 2,500 萬美元，與去年同期相比，增加了約 2,000 萬美元，主要用於 pamrevlumab 開發費用。去年同期相比，增加了約 2,000 萬美元，主要用於 pamrevlumab 開發費用。去年第二季。本季的營運成本和支出還包括 1,900 萬美元的股票補償費用非現金費用，而去年同期的股票補償費用為 1,760 萬美元。

At June 30, FibroGen had $640.5 million in cash, cash equivalents, restricted time deposits, investments and receivables.

截至 6 月 30 日，FibroGen 擁有 6.405 億美元的現金、現金等價物、限制性定期存款、投資和應收帳款。

As we have previously disclosed, starting the first quarter of 2021, the jointly owned distribution entity between AZ and FibroGen, or the JDE, began selling roxadustat to distributors, and paying for AstraZeneca's commercialization efforts in China and AZ's portion of the profit share. Previously, FibroGen was responsible for these items.

正如我們之前所揭露的，從2021 年第一季開始，AZ 和FibroGen 的合資分銷實體（JDE）開始向分銷商銷售羅沙司他，並支付阿斯特捷利康在中國的商業化努力和AZ 的部分利潤分成。此前，FibroGen 負責這些項目。

To provide context for the operating results of our roxadustat business in China, total roxadustat net sales, including sales through the JDE to its distributors and FibroGen China's direct sales to our distributors, was $52.8 million for the second quarter 2021. The JDE accounted for over 97% of the total China roxadustat sales volume. Our net transfer price from sales to the JDE was $17.1 million for the second quarter, which is within the 30% to 45% range of the JDE's roxadustat net sales to which we previously guided.

為了提供羅沙司他在中國業務經營業績的背景信息，2021 年第二季度羅沙司他淨銷售額總額（包括透過JDE 向其分銷商的銷售以及FibroGen 中國向分銷商的直接銷售）為5,280萬美元。JDE 佔超過佔中國羅沙司他總銷量的97%。第二季度，我們從銷售到 JDE 的淨轉讓價格為 1,710 萬美元，在我們先前指導的 JDE roxadustat 淨銷售額的 30% 至 45% 範圍內。

After the net transfer price is determined, we defer a certain portion of such net transfer price for revenue recognition purposes under U.S. GAAP. As a result, FibroGen reported $13.4 million in China roxadustat net product revenue for the second quarter 2021. This amount also includes FibroGen's adjusted net transfer price of $11.7 million from sales to the JDE and the balance consisting of our direct sales to China distributors in China.

在確定淨轉讓價格後，我們會延後淨轉讓價格的一部分，以用於美國公認會計準則下的收入確認目的。因此，FibroGen 公佈的 2021 年第二季中國 roxadustat 產品淨收入為 1,340 萬美元。這一金額還包括 FibroGen 調整後的向 JDE 銷售的淨轉讓價格 1,170 萬美元，以及我們直接向中國經銷商銷售的餘額。

Looking ahead at our broader financial picture, we have a total of $120 million in potential milestones expected for anticipated EU approval in DD and NDD by year-end. Based on our latest forecast, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments and receivables to be in the range of $480 million to $490 million, assuming EU roxadustat approval in 2021.

展望更廣泛的財務狀況，我們預計到年底歐盟將批准 DD 和 NDD，從而實現總計 1.2 億美元的潛在里程碑。根據我們的最新預測，假設歐盟 roxadustat 於 2021 年獲得批准，我們預計 2021 年期末現金、現金等價物、受限定期存款、投資和應收帳款餘額將在 4.8 億至 4.9 億美元之間。

Thank you. And I would now like to turn the call back over to Enrique.

謝謝。現在我想把電話轉回給恩里克。

Thank you, Pat. And in closing, roxadustat continues to perform very well in China. We expect a decision in Europe by the end of August, and we have multiple regulatory submissions under review in other geographies. Pamrevlumab is a potential first-in-class medicine in Phase 3 development in three indications with significant unmet medical need, locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy and idiopathic pulmonary fibrosis. Finally, we continue to advance our research agenda by advancing our internal candidates and accessing external innovation like the HiFiBiO deal.

謝謝你，帕特。最後，羅沙司他在中國繼續表現出色。我們預計歐洲將於 8 月底做出決定，並且其他地區的多項監管提交正在接受審查。 Pamrevlumab 是一種處於 3 期開發的潛在一流藥物，適用於醫療需求未滿足的三種適應症：局部晚期不可切除的胰腺癌、杜氏肌肉營養不良症和特發性肺纖維化。最後，我們透過推進內部候選人和獲取外部創新（例如 HiFiBiO 交易）來繼續推進我們的研究議程。

As shown on Slide 12, we continue to have a strong financial position with approximately $641 million in cash and another $120 million in anticipated roxadustat milestone payments expected during 2021, assuming EU approval later this year.

如投影片 12 所示，我們繼續保持強勁的財務狀況，假設今年稍後獲得歐盟批准，預計 2021 年將有約 6.41 億美元的現金和另外 1.2 億美元的 roxadustat 里程碑付款。

Now I would like to turn the call back to the operator for questions.

現在我想將電話轉回給接線員詢問問題。

(Operator Instructions) Your first question comes from the line of Michael Yee with Jefferies.

（操作員說明）您的第一個問題來自 Jefferies 的 Michael Yee。

We just wanted to ask you about how to think about the upcoming next steps after whatever FDA decision comes. I mean I think it's safe to say that the market assumes a negative decision. And if that's the case, how should we expect the ongoing partnership with AstraZeneca to progress? And are you having discussions that would include all options on the table? Maybe just talk to that because I think that that's what people are trying to figure out what the next step will be in the U.S.

我們只是想問您在 FDA 做出任何決定後如何考慮接下來的步驟。我的意思是，我認為可以肯定地說市場做出了負面決定。如果是這樣的話，我們與阿斯特捷利康的持續合作關係該如何進展？你們正在進行的討論是否包括所有可供選擇的選項？也許只是談論這個，因為我認為這就是人們試圖弄清楚美國下一步將是什麼的問題。

Yes. Clearly, I want to ensure that we don't get ahead of any FDA action. But clearly, you have to assume that we're planning on all scenarios here. And it's going to, of course, based on our discussions -- and we've had some discussions with both the FDA and AstraZeneca, we need to -- we've been working basically to try to understand a potential path forward here. We expect a decision -- I think it's difficult to say. We have not been given any timeline for that. But I think you witnessed the AdCom just like we did. Of course, we were quite disappointed and surprised with the vote, how that discussion turned out and the final outcome of the vote.

是的。顯然，我想確保我們不會領先 FDA 的任何行動。但顯然，您必須假設我們正在規劃這裡的所有場景。當然，基於我們的討論——我們已經與 FDA 和阿斯特捷利康進行了一些討論，我們需要——我們基本上一直在努力嘗試了解這裡的潛在前進道路。我們期待做出決定——我認為這很難說。我們還沒有得到任何時間表。但我覺得您跟我們一樣見證了 AdCom。當然，我們對投票結果、討論結果以及投票的最終結果感到非常失望和驚訝。

Clearly, under a scenario of a complete response letter, we'll need to see what the details are for that complete response letter and make decisions appropriately. But there's no question under any of those scenarios, we will have to make significant reallocation of resources and corresponding reduction in expenses with that. As I mentioned, we are expecting a decision in Europe by the end of this month. So we are excited about that.

顯然，在完整回信的情況下，我們需要查看完整回信的詳細資訊並做出適當的決定。但毫無疑問，在任何一種情況下，我們都必須對資源進行重大重新分配，並相應減少開支。正如我所提到的，我們預計歐洲將在本月底做出決定。所以我們對此感到興奮。

I don't know, Mark, if you want to make any additional comments?

不知道馬克，您是否還有什麼補充意見？

No. Thanks, Enrique. I think you summarized it well. I mean we're working collaboratively with the FDA and AstraZeneca to find the path forward, and we await the FDA's decision and next steps.

不，謝謝，恩里克。我覺得你總結得很好。我的意思是，我們正在與 FDA 和阿斯特捷利康合作尋找前進的道路，我們等待 FDA 的決定和後續步驟。

Your next question comes from the line of Annabel Samimy with Stifel.

你的下一個問題來自安娜貝爾·薩米米（Annabel Samimy）和斯蒂菲爾（Stifel）的線路。

Thanks for taking my questions. And I apologize if I missed the initial comments. But maybe you can sort of talk to us about the chemotherapy-induced anemia studies. I saw that they are completed in clinicaltrials.gov. Can you tell us when and in what form of that data might be reporting out? And is there anything that you can pull from these studies that might help you address some of the issues that you came across in the dialysis and the nondialysis CKD studies. And yes, that's essentially my question. I'll wait to follow up with my other one.

感謝您回答我的問題。如果我錯過了最初的評論，我深表歉意。但也許你可以和我們談談化療引起的貧血研究。我看到它們已在 ClinicalTrials.gov 上完成。您能否告訴我們這些數據何時以及以何種形式報告？您可以從這些研究中獲得什麼資訊來幫助您解決在透析和非透析 CKD 研究中遇到的一些問題。是的，這本質上就是我的問題。我會等待跟進我的另一件事。

We've really finalized the Phase II study for chemo-induced anemia. And at this point in time, we're expecting to report topline data imminently. I'm going to ask maybe Mark Eisner to provide some more color on whether any of this data can help any type of discussions with the FDA or how do we think about this data.

我們已經真正完成了化療引起的貧血的第二期研究。此時，我們預計將立即報告頂線數據。我可能會請 Mark Eisner 提供更多信息，說明這些數據是否有助於與 FDA 進行任何類型的討論，或者我們如何看待這些數據。

Yes. So thanks. It's an interesting question. I think the short answer is no. I mean chemotherapy-induced anemia and CKD are very different indications, very different patient populations. So I don't see CIA informing the CKD decision or the assessment there. That said, we feel -- we're looking forward to see the topline data, the Phase II data, looking forward to sharing those shortly and thinking about what the pathway could be for CIA as an indication.

是的。那謝謝啦。這是一個有趣的問題。我認為簡短的答案是否定的。我的意思是化療引起的貧血和 CKD 是非常不同的適應症，也是非常不同的患者群體。所以我沒有看到 CIA 通知 CKD 決定或那裡的評估。也就是說，我們覺得——我們期待看到最重要的數據，即第二階段的數據，期待盡快分享這些數據，並思考中央情報局可能採取的途徑作為指示。

Okay. Great. And if I could just ask on -- obviously, it was clear from the panel that the physicians wanted to see a titration study, not a simulated modeling study of what titration can do. Given that these thrombotic events occur earlier in treatment, do you think that a titration study would be relatively short? Is this something that could be conducted rapidly? Or am I thinking about this incorrectly?

好的。偉大的。如果我可以繼續問的話——顯然，專家小組清楚地表明，醫生希望看到滴定研究，而不是滴定作用的模擬模型研究。鑑於這些血栓事件發生在治療早期，您認為滴定研究的時間會相對較短嗎？這是可以快速進行的事情嗎？或者我對這個問題的思考是錯的？

Mark?

標記？

Yes, thanks for the question. Just to start out to say that we believe that the benefit/risk of roxadustat for the treatment of CKD anemia in both the NDD and DD populations is favorable with the dosing regimen that we studied in Phase 3. But we did collaborate with FDA on some analyses, as you know, looking at rate of rise of hemoglobin and a relationship with thrombotic events. And we do believe that starting at a lower starting dose of roxadustat and titrating up will be a very reasonable approach to treating patients and mitigating the risk. We actually don't believe another trial is needed to prove the hypothesis. It's well established in the ESA field over the last 2 or 3 decades, and we think the same applies with roxadustat.

是的，謝謝你的提問。首先要說的是，我們相信 roxadustat 在 NDD 和 DD 人群中治療 CKD 貧血的益處/風險與我們在第 3 期研究的給藥方案是有利的。但我們確實與 FDA 在一些方面進行了合作如您所知，分析著眼於血紅素的上升率以及與血栓事件的關係。我們確實相信，從較低的羅沙司他起始劑量開始並逐漸增加劑量將是治療患者和降低風險的非常合理的方法。我們實際上不認為需要另一次試驗來證明這個假設。過去 2 到 3 年來，它在 ESA 領域已經很成熟，我們認為 roxadustat 也是如此。

In terms of what study the FDA may or may not ask us to do, this remains an open question. And I think it's difficult to speculate right now, and we're just waiting for input from the agency on that.

就 FDA 可能要求或不要求我們進行哪些研究而言，這仍然是一個懸而未決的問題。我認為現在很難推測，我們只是在等待該機構對此的意見。

Your next question comes from the line of Geoffrey Porges with SVB Leerink.

您的下一個問題來自 SVB Leerink 的 Geoffrey Porges。

I was just wondering, could you tell us whether there's been any correspondence from the EMA since the AdCom requesting additional information or analysis? Or is the file that you originally submitted beyond the information you've been asked to provide? And then secondly, just in terms of the expenses, I think by the end of the year, it looks like you have about $460 million, $470 million in net cash, and you had a burn rate this quarter of $134 million. I know there were one-time items in that burn rate, but it looks as though, by the end of the year, you might have 1 year to 1.5 years of cash left. What are the options you have to significantly reducing the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level?

我只是想知道，您能否告訴我們自 AdCom 要求提供額外資訊或分析以來 EMA 是否有任何信件？或者您最初提交的文件是否超出了要求您提供的資訊？其次，就支出而言，我認為到今年年底，您將擁有約 4.6 億美元、4.7 億美元的淨現金，而本季的燒錢率為 1.34 億美元。我知道燒錢率中有一次性項目，但看起來到年底，你可能還剩下 1 年到 1.5 年的現金。你有哪些選擇可以大幅減少公司的現金消耗，這樣你就不需要在估值水準大幅下降的情況下為公司再融資？

Mark, do you want to discuss the first part of the question, I'll discuss the burn rate.

馬克，你想討論問題的第一部分嗎？我將討論燃燒率。

Sure. So the question is, since the AdCom, has there been any communication from or to EMA? The answer to my knowledge is no. There's been none. And we don't anticipate any impact on the European Commission decision in August.

當然。所以問題是，自從 AdCom 以來，EMA 是否有過任何溝通？據我所知，答案是否定的。沒有。我們預計歐盟委員會八月的決定不會受到任何影響。

Yes. On your question about the burn rate, first, I think we have no intention of raising money. I think we have, as I mentioned, a number of scenarios that we're working on. Clearly, under a scenario of a complete response letter, we would need to basically reassess our priorities and reallocate our resources and significantly decrease expenses. There are a number of plans that we have to ensure that we can deliver value for shareholders. And clearly, under that scenario -- yes, we do have roxadustat in China, in a number of markets. And keep in mind that China is now basically profitable. And in the rest of the markets, we do not -- we are reimbursed for any expenses. So we do not have any expenses when it comes to both commercial and development expenses. We will be getting a royalty.

是的。關於你關於燒錢率的問題，首先，我認為我們無意籌集資金。正如我所提到的，我認為我們正在研究許多方案。顯然，在完整回覆信的情況下，我們基本上需要重新評估我們的優先事項並重新分配我們的資源並大幅減少開支。我們必須制定許多計劃來確保我們能夠為股東創造價值。顯然，在這種情況下，是的，我們在中國的許多市場上確實有羅沙司他。請記住，中國現在基本上是盈利的。在其他市場，我們不會——我們會報銷任何費用。所以我們在商業和開發方面都沒有任何費用。我們將獲得版稅。

And of course, we need to ensure that we can get to the readouts of pamrevlumab as soon as possible. So that's priority one. But yes, there's no question that we have to ensure that we are going to be able to basically bridge for us to be able to see the data and be able to launch pamrevlumab.

當然，我們需要確保能夠盡快獲得 pamrevlumab 的讀數。所以這是第一要務。但是，毫無疑問，我們必須確保我們能夠基本上建立橋樑，以便我們能夠看到數據並能夠推出 pamrevlumab。

Your next question comes from the line of Edwin Zhang with H.C. Wainwright.

您的下一個問題來自 Edwin Zhang 和 H.C.溫賴特。

On China revenue, can you help us understand why the net roxa revenue that FibroGen booked this quarter was $2 million less than last quarter, while the total net revenue and hospital listings were actually both increasing? Also, do you expect any roxa pricing pressure in the upcoming NRDL negotiation in China? And then I have a follow-up.

關於中國收入，您能否幫助我們理解為什麼 FibroGen 本季預訂的 roxa 淨收入比上季減少了 200 萬美元，而總淨收入和醫院清單實際上都在成長？另外，您預計在中國即將舉行的國家健保目錄談判中，roxa 的定價是否會面臨壓力？然後我有一個後續行動。

Yes. I'm going to ask maybe Pat to comment on the first question on the net revenue that FibroGen booked $2 million less while the overall sales to distributors basically continuing to increase. By the way, of course, we see the overall net sales to distributors as really the fundamentals of the business and one thing to be able to look at. We'll have Pat Cotroneo, our CFO, address that question. And then we'll have Chris talk about the NRDL and what are our expectations there.

是的。我可能會請帕特對第一個問題發表評論，即 FibroGen 的淨收入減少了 200 萬美元，而對分銷商的總體銷售額基本上繼續增加。順便說一句，當然，我們將經銷商的整體淨銷售額視為業務的基本面，也是值得關注的一件事。我們將請我們的財務長 Pat Cotroneo 來解答這個問題。然後我們會讓 Chris 談論 NRDL 以及我們對此的期望是什麼。

Thank you, Enrique. Thank you for the question. To start, just as a reminder, as I mentioned in my prepared remarks, we have deferred revenue, and this is from adjustments to our net transfer price to reflect U.S. GAAP. These adjustments are required for accounting purposes because we have manufacturing and supply obligations to the JDE over an estimated performance period. So what you're seeing here is just a deferral of a portion of the revenue to latter years. And accordingly, we deferred $3.9 million in Q1 of 2021 and then approximately $5.4 million in Q2 of 2021. So this is strictly related to performance obligations and the GAAP requirements under revenue recognition rules. Chris?

謝謝你，恩里克。感謝你的提問。首先，提醒一下，正如我在準備好的發言中提到的，我們遞延收入，這是來自對我們的淨轉讓價格的調整，以反映美國公認會計準則。出於會計目的，需要進行這些調整，因為我們在預計的履約期間內對 JDE 負有製造和供應義務。因此，您在這裡看到的只是將部分收入推遲到幾年後。因此，我們在 2021 年第一季遞延了 390 萬美元，然後在 2021 年第二季遞延了約 540 萬美元。因此，這與收入確認規則下的履約義務和 GAAP 要求嚴格相關。克里斯？

Chris, can you comment on the NRDL?

Chris，您能對國家健保目錄發表評論嗎？

Absolutely, Enrique. So with regard to NRDL, as to the question of whether there will be a change in pricing starting next year, the answer is yes. Per the rules of NRDL, every single 2 years, the price is renegotiated. As you know, last time we entered NRDL in January 1, 2020, and we will have a new price for 2022 January 1. The direction of these negotiations is always downward, so it's not a question of whether but how much. There is a very well-established process in terms of how prices are determined. It's typically based on clinical value, and we stand behind the clinical value demonstrated by roxadustat. And as you have seen in the very strong sales in the last couple of quarters, we also have very strong key opinion leader support from clinical key opinion leaders, pharmacologists and pharmacies. Finally, FibroGen and AstraZeneca believe that we're uniquely positioned as an innovative drug to deliver value not just to patients but to the health care system, so we remain optimistic in terms of what the pricing outcome might look like in Q4 of this year.

絕對是，恩里克。那麼對於健保來說，對於明年開始價格是否會改變的問題，答案是肯定的。根據國家健保目錄的規定，價格每兩年重新協商一次。如你所知，上次我們進入健保是在2020年1月1日，我們將在2022年1月1日有一個新的價格。這些談判的方向總是向下的，所以這不是是否的問題，而是多少的問題。在如何確定價格方面有一個非常完善的流程。它通常基於臨床價值，我們支持羅沙司他所展示的臨床價值。正如您在過去幾季非常強勁的銷售中看到的那樣，我們還得到了來自臨床關鍵意見領袖、藥理學家和藥房的非常強大的關鍵意見領袖支持。最後，FibroGen 和阿斯特捷利康相信，我們作為創新藥物的獨特定位，不僅可以為患者創造價值，還可以為醫療保健系統創造價值，因此我們對今年第四季的定價結果保持樂觀。

Great. I have a follow-up on the U.S. I was also wondering what's your future plan on roxa in CKD anemia in the U.S. Are you willing to do additional safety studies and prepare for resubmission some years later? Or would you rather drop the CKD anemia indication in the U.S., assuming roxa won't receive FDA approval?

偉大的。我對美國有一個後續行動，我也想知道您在美國對 roxa 治療 CKD 貧血的未來計劃是什麼。您願意做額外的安全性研究並為幾年後重新提交做準備嗎？或者假設 roxa 不會獲得 FDA 批准，您是否寧願放棄在美國的 CKD 貧血適應症？

Yes. As we mentioned, we don't want to speculate on the action by the FDA. And of course, if we were to get a complete response letter, what would be the terms of that complete response letter, so it's difficult to comment on your question without having the action and any potential specifics there.

是的。正如我們所提到的，我們不想猜測 FDA 的行動。當然，如果我們要收到完整的回覆信，完整回覆信的條款是什麼，因此如果沒有行動和任何潛在的細節，就很難對您的問題發表評論。

Your next question comes from the line of Yaron Werber with Cowen.

你的下一個問題來自 Yaron Werber 和 Cowen 的對話。

Great. I have a couple of questions that are interrelated, Enrique, if I can. The first one, just given valuations in China right now on companies in China that are dual-listed or listing in Hong Kong, has there ever been a discussion to see whether you should spin out the China sub into its own independent company and sort of rerate the valuations there? And then secondly, depending on which way FDA goes here from something small to a whole new study in a much more complicated development path, and in case AZN decides that this might not fit in with their strategy, can they exit the partnership in the U.S. but remain intact with you in China? Or is it a one size fits all?

偉大的。恩里克，如果可以的話，我有幾個相互關聯的問題。第一個，剛剛考慮到目前在中國雙重上市或在香港上市的中國公司的估值，是否曾經討論過是否應該將中國子公司分拆成自己的獨立公司，並進行某種程度的討論。重新評估那裡的估值？其次，取決於 FDA 在更複雜的開發道路上從小型研究到全新研究的方式，如果 AZN 認為這可能不符合他們的策略，他們是否可以退出在美國的合作夥伴關係。但在中國仍與你保持原樣？還是一刀切？

Yes. Clearly, when it comes to China, we think that we have a meaningful business in China and meaningful capabilities as shown by the type of results and performance that we're basically getting there. And yes, we are looking at -- and we've looked at all options, and we're looking at all options in China to ensure that the value that we have there is basically better reflected on our share price. So that's something that we are very much looking at.

是的。顯然，就中國而言，我們認為我們在中國擁有有意義的業務和有意義的能力，正如我們基本上取得的成果和績效類型所顯示的那樣。是的，我們正在考慮——我們已經考慮了所有選擇，我們正在考慮在中國的所有選擇，以確保我們在那裡擁有的價值基本上更好地反映在我們的股價上。所以這是我們非常關注的事情。

When it comes to the partnership, the partnership with both Astellas and AstraZeneca is very collaborative at this stage despite the very negative outcome of the AdCom that we had in the U.S. And I expect that's going to continue to be the case. We clearly want to see the FDA action, and we do have additional indications that we're pursuing. Keep in mind that MDS is a Phase 3 trial ongoing, and we are about to see the CIA data. And of course, based on that underlying data, we will be making a decision about how do we proceed with that indication.

在合作關係方面，儘管我們在美國的AdCom 會議中取得了非常負面的成果，但我們與安斯泰來和阿斯特捷利康的合作關係在現階段是非常合作的，我預計這種情況將繼續下去。我們顯然希望看到 FDA 採取行動，並且我們確實有我們正在尋求的其他跡象。請記住，MDS 是正在進行的第三階段試驗，我們即將看到 CIA 的數據。當然，根據這些基礎數據，我們將決定如何繼續該指示。

Your next question comes from the line of Andy Hsieh with William Blair.

你的下一個問題來自安迪·謝（Andy Hsieh）和威廉·布萊爾（William Blair）的對話。

So one of the take-home messages from the AdCom is that there is tremendous interest from the physician community about the hyporesponders. So I'm not asking about making projections, but I want to understand the collaboration framework. So let's say, hypothetically, if the parties decide to go forward with that study, how is the decision being made? Is there like a joint steering committee across the three companies to make a go and no-go decision? And then also, I guess, from a financials perspective, is there additional cost from the FibroGen standpoint on R&D or you have already hit the limit?

因此，AdCom 傳達的重要訊息之一是，醫生界對低迴應者表現出極大的興趣。所以我不是問做預測，而是想了解協作框架。那麼，假設一下，如果雙方決定繼續進行這項研究，那麼這個決定是如何做出的呢？三家公司之間是否有一個聯合指導委員會來做出是否繼續的決定？然後，我想，從財務角度來看，從 FibroGen 的角度來看，研發方面是否存在額外成本，或者您已經達到了極限？

And then the second question I have for Chris. Looking at Slide #8, it seems like the ESA market in China is growing, and then it seems like you're basically growing both the ESA and, obviously, roxadustat. I'm just curious if you can comment on the dynamic. Are you kind of growing the market? Or is there also some element of switching from ESA?

然後是我要問克里斯的第二個問題。看看幻燈片 #8，中國的 ESA 市場似乎正在成長，而且 ESA 和羅沙司他顯然都在成長。我只是好奇你能否對動態發表評論。你們在發展市場嗎？或者是否還有一些從歐空局轉換的因素？

Yes. Maybe just -- let me try to address the question about FibroGen's expenses when it comes to commercial or development expenses for roxadustat. As I mentioned, outside of China, we have no expenses related to roxadustat, either on the commercial or development side. So we are fully reimbursed, and that will be the case as well if we were to pursue additional trials.

是的。也許只是 - 讓我嘗試解決有關 roxadustat 商業或開發費用時 FibroGen 費用的問題。正如我所提到的，在中國以外，我們沒有與羅沙司他相關的費用，無論是商業方面還是開發方面。因此，我們得到了全額報銷，如果我們要進行額外的試驗，情況也是如此。

I'm going to ask maybe Mark to comment on the governance that we have, how are decision made when it comes to additional trials. In particular, I think there was this question about trials in ESA hyporesponders. Mark?

我可能會請馬克對我們的治理發表評論，在涉及額外試驗時如何做出決策。特別是，我認為存在著關於歐空局低反應者試驗的問題。標記？

Right. So the ESA hyporesponder group, I mean, you're quite right, several members of the Advisory Committee noted that, that was a high unmet need for patients and were intrigued by our data, both in patients with high systemic inflammation and functional iron deficiency that actually we have some data that do suggest roxadustat is effective in ESA hyporesponders. If we were to embark on another trial, it would be a joint decision between FibroGen and AstraZeneca and FibroGen and Astellas. I mean we have joint steering committee governance at the higher level, and we have governance at a more team level on both -- with both companies, and we aim to make decisions that are good for the tripartite and that everyone is aligned on. So we do have good governance procedures in place, highly collaborative relationships with both companies. And once we know what the FDA's expectations are, we'll be in a good position to move forward.

正確的。因此，ESA 反應低下小組，我的意思是，您說得很對，諮詢委員會的幾位成員指出，對於患者來說，這是一個未得到滿足的高度需求，並且對我們的數據很感興趣，無論是在患有高度全身性發炎和功能性缺鐵的患者中事實上，我們有一些數據確實表明羅沙司他對 ESA 低反應者有效。如果我們要開始另一項試驗，這將是 FibroGen 和阿斯利康以及 FibroGen 和安斯泰來之間的共同決定。我的意思是，我們在更高層級上有聯合指導委員會治理，並且我們在兩家公司的團隊層面上都有治理，我們的目標是做出對三方有利且每個人都一致的決策。因此，我們確實制定了良好的治理程序，並與兩家公司建立了高度合作的關係。一旦我們知道 FDA 的期望是什麼，我們就能更好地向前邁進。

And Chris, if you could comment on roxa in China, whether it's just growing the market or is also just capturing new patients versus just switching. I don't know if you could provide some additional color to that.

克里斯，如果您能評論一下羅莎在中國的情況，無論它是為了擴大市場還是只是為了吸引新患者而不是僅僅轉換患者。我不知道你是否可以為此提供一些額外的顏色。

Absolutely, Enrique. So the answer to the question is it is both. The category of ESA and HIFs together in the class of anemia treating agents, is growing. It's growing because there is increased awareness of the importance of treating the disease. The class share of HIF is also growing, and we are seeing conversion of patients from ESA to HIF.

絕對是，恩里克。所以問題的答案是兩者都是。 ESA 和 HIF 一起作為貧血治療藥物的類別正在不斷增長。它的增長是因為人們越來越意識到治療這種疾病的重要性。 HIF 的類別份額也在增長，我們看到患者從 ESA 轉向 HIF。

Your next question comes from the line of Difei Yang with Mizuho.

你的下一個問題來自楊迪飛和瑞穗的對話。

I'm just curious how do the Chinese doctors react to clearly a split opinion between the EU regulatory agency versus the U.S.? And do you expect this discrepancy will eventually lead to some changes in the demand for roxa in China.

我只是好奇中國醫生對歐盟監管機構與美國監管機構之間明顯的分歧有何反應？您是否預計這種差異最終會導致中國對 roxa 的需求發生一些變化？

I'm going to ask Chris to maybe comment on the reaction in China, and I would try to complement Chris' comments.

我會請克里斯對中國的反應發表評論，我會盡力補充克里斯的評論。

Absolutely. China has a slightly different patient population than what was covered in the global trials. And based on our historical Phase 3 experience as well as real-world evidence based on 2.5 years of on-market use in China, our Chinese key opinion leaders are seeing slightly different event rates. At this point in time, we're not seeing any over concern by our key investigators and key opinion leaders and HCPs about the U.S. regulatory guidance based on the AdCom. As you know, every single health authority makes its own sovereign decision. FibroGen China sought approval of China based on a domestic Class 1.1 pathway, which meant that the data was only based on China data. And to date, our real-world evidence is consistent with that experience. So at this point in time, we're not expecting any impact or any significant impact on prescription levels and continued widespread adoption of roxadustat in China based on the AdCom outcome.

絕對地。中國的患者群體與全球試驗中涵蓋的患者群體略有不同。根據我們第 3 階段的歷史經驗以及基於中國 2.5 年市場使用的現實證據，我們的中國關鍵意見領袖看到的事件發生率略有不同。目前，我們沒有看到我們的主要調查人員、主要意見領袖和 HCP 對基於 AdCom 的美國監管指南有任何過度擔憂。如您所知，每個衛生當局都會做出自己的主權決定。 FibroGen中國根據國內1.1類途徑尋求中國的批准，這意味著數據僅基於中國數據。迄今為止，我們的現實世界證據與這項經驗是一致的。因此，根據 AdCom 結果，目前我們預計羅沙司他在中國的處方水平和持續廣泛使用不會受到任何影響或任何重大影響。

I think it's fair to say we -- as far as the AdCom, we shared some data on real-world data when it comes to pharmacovigilance in China. And we saw some of the reported rates in the real world when it comes to thrombosis, for example, were very, very low.

我認為可以公平地說，就 AdCom 而言，我們分享了一些有關中國藥物警戒的真實世界數據。例如，我們看到現實世界中一些報告的血栓形成率非常非常低。

Okay. And then my other question is related to the delays in some of the trials, more specifically the MDS trial as well. I'm sorry, let me -- yes, it's the MDS trial as well as the DMD trial. And so could you give us a little bit more color of what's causing this? Is it a slow enrollment? Or is it something else?

好的。我的另一個問題與一些試驗的延誤有關，更具體地說是 MDS 試驗的延誤。抱歉，讓我——是的，這是 MDS 試驗以及 DMD 試驗。那麼您能給我們更多關於造成這種情況的原因嗎？招生速度慢嗎？還是別的什麼？

Yes, we will provide a little bit of comment. It is really related to enrollment. And of course, enrollment is also impacted by current conditions. And we are seeing right now conditions that are more challenging due to COVID, so some of the COVID concerns. And clearly, that creates a bit of a disproportionate impact when we look at our trials in three patient populations, MDS, DMD and IPF. And the current timelines that we provided assume that these current conditions basically continue on.

是的，我們將提供一些評論。確實和招生有關係。當然，入學率也受到當前狀況的影響。我們現在看到，由於新冠疫情，情況變得更具挑戰性，因此我們對新冠疫情感到擔憂。顯然，當我們在三個患者群體（MDS、DMD 和 IPF）中進行試驗時，這會產生一些不成比例的影響。我們提供的當前時間表假設這些當前情況基本上會持續下去。

Mark, would you like to share more color?

馬克，你想分享更多的顏色嗎？

Sure, Enrique. And I agree with the comments about COVID. I mean for MDS, as you know, I mean it's a rare disease. It's a 52-week placebo-controlled period. So it's challenging to find the patients to enroll. We have opened up more than 40 additional sites around the world, and we are seeing increases in enrollment in those sites. So we're making every effort to enroll the MDS trial. And the way I would characterize it is it's just there's a lot of uncertainty around the enrollment rates month-to-month, and we are pushing very hard, though, and working very collaboratively with our investigators to enroll those trials. I mean DMD, similarly a very rare disease, these are young kids, in many cases. And the COVID situation looms large for the parents of those children and those children. So again, we're trying very hard to make those trials as user-friendly as possible and doing everything we can to enroll those.

當然，恩里克。我同意關於新冠病毒的評論。我的意思是MDS，正如你所知，我的意思是它是一種罕見的疾病。這是一個為期 52 週的安慰劑對照期。因此，找到可以入組的患者非常困難。我們在世界各地開設了 40 多個站點，這些站點的註冊人數正在增加。因此，我們正在盡一切努力參加 MDS 試驗。我的描述是，每個月的入組率存在著許多不確定性，但我們正在非常努力地推動，並與我們的研究人員密切合作來入組這些試驗。我的意思是 DMD，同樣是一種非常罕見的疾病，很多情況下都是年幼的孩子。對這些孩子的父母和孩子來說，新冠疫情的影響尤其嚴峻。因此，我們再次努力使這些試驗盡可能方便用戶，並盡一切努力招募這些試驗。

On the positive side, I mean, the pamrevlumab LAPC trials are actually enrolling very, very well, which I think speaks to the high unmet medical need in that condition and the excitement around pam for those conditions. So that's very favorable. And the ZEPHYRUS-1 IPF timeline, we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID, adding additional sites, working closely with the sites to enroll those patients. And also with the Galapagos and Gilead discontinuation, we've been working to try to capture the patients who otherwise would have been candidates for those trials into our trial. So that's looking pretty good right now.

我的意思是，從積極的一面來看，pamrevlumab LAPC 試驗的入組情況實際上非常非常好，我認為這說明了這種情況下未滿足的醫療需求很高，以及人們對pam 對這些情況的興奮。所以這是非常有利的。我們首次公開宣布了 ZEPHYRUS-1 IPF 時間表，因為儘管有新冠疫情，但我們在入組方面取得了非常好的進展，增加了更多站點，與這些站點密切合作以入組這些患者。隨著加拉巴哥和吉利德的停藥，我們一直在努力將原本可以參加這些試驗的患者納入我們的試驗。所以現在看起來相當不錯。

Your next question comes from the line of Paul Choi with Goldman Sachs.

你的下一個問題來自高盛的 Paul Choi。

This is Charlie on for Paul. I just had a quick one regarding the upcoming European decision and subsequent events. How are conversations going with partner Astellas for the region? Are they talking about their commercialization strategies pending the approval with the EMA? Are they going to be focusing on certain countries at this point? And are they incorporating any sort of kind of virtual or remote marketing efforts considering the potential threat for further COVID lockdowns later this year?

這是查理替保羅發言。我剛剛快速了解了即將到來的歐洲決定和隨後發生的事件。與該地區合作夥伴安斯泰來的對話進展如何？他們是否正在討論等待 EMA 批准的商業化策略？他們現在會關注某些國家嗎？考慮到今年稍晚新冠疫情進一步封鎖的潛在威脅，他們是否會採取任何形式的虛擬或遠端行銷工作？

Very good. I'm going to ask our Chief Commercial Officer, Thane Wettig, to provide some comments on the commercialization strategies in Europe, whatever we can share, Thane.

非常好。我將請我們的首席商務官 Thane Wettig 提供一些關於歐洲商業化策略的評論，無論我們能分享什麼，Thane。

Yes. Thanks, Enrique, and thanks, Charlie, for your message. Unfortunately, we're not going to be able to comment very much. Astellas, as you can imagine, is in a highly competitive situation. There are certain things that they're not going to disclose, and we can't disclose on their behalf. I think what you could assume is that relative to a European launch, it's going to take the form of other products that would be launching in Europe. So the traditional markets that are first to launch will be the traditional markets that will be first to launch for roxadustat in Europe as they then work through the other markets from a pricing and reimbursement perspective. Needless to say, there's a lot of excitement because we do have a really nice competitive advantage in the EU from a timing perspective. And I think you can rest assured that Astellas is going to take full advantage of that.

是的。謝謝恩里克，謝謝查理的留言。不幸的是，我們無法發表太多評論。正如您可以想像的那樣，安斯泰來正處於競爭激烈的境地。有些事情他們不會透露，我們也不能代表他們透露。我認為您可以假設，相對於歐洲的推出，它將採取在歐洲推出的其他產品的形式。因此，首先推出羅沙司他的傳統市場將是先在歐洲推出羅沙司他的傳統市場，然後從定價和報銷的角度研究其他市場。不用說，人們非常興奮，因為從時機的角度來看，我們在歐盟確實擁有非常好的競爭優勢。我認為您可以放心，安斯泰來將充分利用這一點。

One -- just to remind everyone that Astellas has guided to revenue of $80 million for fiscal year 2021. That $80 million, it was converted at the exchange rates at the time from yen. About half of that was Japan, if I recall correctly, and about half of that was -- for Astellas was basically Europe outside of Japan. So that's -- and Astellas also provided, as part of their strategic review, an overall peak sales expected for the product which, once again, I'm translating from exchange rates at that time, but they were somewhere between USD 0.5 billion to USD 1 billion in peak revenue when we look at the Astellas territories.

一是提醒大家，安斯泰來 2021 財年的營收目標為 8,000 萬美元。這 8,000 萬美元是以當時的日圓匯率換算的。如果我沒記錯的話，其中大約一半是日本，而安斯泰來基本上是日本以外的歐洲。因此，作為策略審查的一部分，安斯泰來還提供了該產品預期的總體峰值銷售額，我再次根據當時的匯率進行換算，但銷售額在 5 億美元到 10 億美元之間當我們觀察安斯泰來的業務區域時，其高峰收入達到了10 億美元。

Your next question comes from the line of Jason Gerberry with Bank of America.

您的下一個問題來自美國銀行的 Jason Gerberry。

This is Terry on the line for Jason. I have another regarding the CHMP opinion. Is there any risk that it doesn't stick? And additionally, what are the next steps from a regulatory standpoint? And when could we expect to get a label in Europe?

我是特里，正在接聽傑森的電話。我還有另一個關於 CHMP 的意見。有沒有不沾黏的風險？此外，從監管的角度來看，下一步是什麼？我們什麼時候可以在歐洲獲得一個標籤？

As I mentioned, we're expecting a decision this month. We are expecting a European Commission decision. Clearly, the scientific body assessed roxadustat as having a clear benefit/risk profile. Keep in mind that many of the items that were discussed here were discussed as part of the review in Europe.

正如我所提到的，我們預計本月會做出決定。我們期待歐盟委員會的決定。顯然，科學機構評估羅沙司他具有明確的益處/風險特徵。請記住，這裡討論的許多項目都是作為歐洲審查的一部分進行討論的。

And I'm going to ask maybe Mark to maybe make a few additional comments.

我可能會請馬克發表一些補充意見。

I think the point Enrique made is a key one, which is the CHMP has already reviewed all of the efficacy and safety issues that have been up for discussion in the U.S. and issued a positive opinion. We think the European Commission decision will be positive. We don't expect an influence of the U.S. FDA's AdCom on that decision. In terms of the next steps for regulatory in Europe, I believe it's just waiting for that EC decision. And then that's the point in time where the product insert, the SmPC in Europe will become available. So that's basically the regulatory situation in Europe.

我認為恩里克提出的觀點很關鍵，就是CHMP已經審查了美國討論的所有有效性和安全性問題，並發表了正面的意見。我們認為歐盟委員會的決定將是積極的。我們預計美國 FDA 的 AdCom 不會對該決定產生影響。就歐洲監管的下一步措施而言，我認為只是等待歐盟委員會的決定。然後就是產品插入的時間點，SmPC 將在歐洲上市。這基本上就是歐洲的監管情況。

We have no further questions at this time. I will now turn the call back to our presenters for closing remarks.

目前我們沒有進一步的問題。現在，我將把電話轉回給我們的主持人，讓其致閉幕詞。

Very good. I just want to once again just thank everyone for participating. We very much appreciate your participation today in the investor call and your interest in FibroGen. Please enjoy the rest of your day. Thank you very much.

非常好。我只想再次感謝大家的參與。我們非常感謝您今天參加投資者電話會議以及您對 FibroGen 的興趣。請享受您剩下的一天。非常感謝。

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。