ChemoCentryx Inc (CCXI) 2022 Q1 法說會逐字稿

Good afternoon, and welcome to the ChemoCentryx First Quarter 2020 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call will be recorded.

下午好，歡迎參加 ChemoCentryx 2020 年第一季財務業績電話會議。 (操作員指示) 溫馨提示：本次電話會議將會被錄音。

I would now like to turn the call over to Mr. Bill Slattery Jr., Vice President of Investor Relations and Corporate Communications at ChemoCentryx. Mr. Slattery, Please go ahead.

現在我想把電話轉給 ChemoCentryx 公司投資者關係和企業傳播副總裁 Bill Slattery Jr. 先生。 Slattery 先生，請您發言。

Thank you, operator. Good afternoon, and welcome to the ChemoCentryx First Quarter 2022 Financial Results Conference Call. Earlier this afternoon, the company issued a press release providing an overview of its financial results for the quarter ended March 31, 2022. This press release, along with the slide deck, that you may find helpful while you listen to this call, are available on the Investor Relations section of our website at www.chemocentryx.com.

謝謝接線生。下午好，歡迎參加 ChemoCentryx 2022 年第一季財務業績電話會議。今天下午早些時候，該公司發布了一份新聞稿，概述了截至 2022 年 3 月 31 日的季度財務表現。這份新聞稿以及投影片（可能對您在收聽電話會議時有所幫助）可在我們網站 www.chemocentryx.com 的「投資者關係」板塊取得。

Joining us on the call today from ChemoCentryx are Dr. Thomas Schall, President and Chief Executive Officer and Chairman of the Board; Susan Kanaya, Executive Vice President, Chief Financial and Administrative Officer; and Tausif Butt, Executive Vice President and Chief Operations Officer. Tom and Susan will make introductory remarks before we open the call to your questions.

今天，ChemoCentryx 的總裁兼執行長兼董事會主席 Thomas Schall 博士、執行副總裁兼首席財務和行政官 Susan Kanaya 以及​​執行副總裁兼首席營運長 Tausif Butt 將參加我們的電話會議。 Tom 和 Susan 會先做開場白，之後我們將開始回答大家的提問。

During today's call, we will be making certain forward-looking statements. As explained on Slide 2, these forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These risks are described in the company's filings made with the Securities and Exchange Commission, including our annual report on Form 10-K filed on March 1, 2022.

在今天的電話會議中，我們將做出一些前瞻性陳述。如投影片2所述，這些前瞻性陳述是基於當前資訊、假設和預期，這些資訊、假設和預期可能會發生變化，並涉及一系列風險和不確定性，可能導致實際結果與前瞻性陳述中的結果有重大差異。這些風險已在公司向美國證券交易委員會提交的文件中進行了描述，包括我們於2022年3月1日提交的10-K表格年度報告。

You are cautioned not to place undue reliance on these forward-looking statements and ChemoCentryx disclaims any obligation to update such statements. In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 5, 2022. ChemoCentryx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this live conference call.

請注意，請勿過度依賴這些前瞻性陳述，ChemoCentryx 不承擔更新此類陳述的任何義務。此外，本次電話會議所包含的時間敏感資訊僅在本次直播之日（2022 年 5 月 5 日）有效。 ChemoCentryx 不承擔修改或更新任何前瞻性陳述以反映本次直播電話會議之後發生的事件或情況的義務。

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

說完這些，我會把電話轉給湯姆。

Thank you, Bill, and good afternoon to everyone listening. Thank you all for joining us. Please move to Slide 3 in our presentation. We had an excellent first quarter of 2022. We outperformed our own expectations with U.S. net product sales reaching USD 5.4 million in Q1. All the key performance indicators we are tracking significantly improved over Q4, confirming we are right where we need to be at this stage in the launch. Additional regional approvals in the European Union and Canada, build on TAVNEOS' global footprint, along with launches in Germany and Austria through our partner, Vifor Pharma.

謝謝比爾，各位聽眾，大家午安！感謝各位的參與。請移至簡報的第三張投影片。 2022年第一季度，我們取得了優異的成績。我們的業績超出預期，美國淨產品銷售額在第一季達到540萬美元。我們追蹤的所有關鍵績效指標均較第四季顯著提升，證明我們正處於產品上市的這個階段，並已達到預期目標。 TAVNEOS 已獲得歐盟和加拿大的更多區域批准，這進一步鞏固了其全球佈局，同時，我們也透過合作夥伴 Vifor Pharma 在德國和奧地利完成了產品上市。

Improving on our cash balance, we received a USD 45 million nonrefundable milestone payment from Vifor following the EU approval. The USD 371.8 million in cash and investments, we ended the quarter that places us in a strong financial position to execute on our planned objectives. Among these objectives are advancing our novel once daily orally administered PD-L1 checkpoint inhibitor, CCX559. At the American Association of Cancer Research or AACR meeting in April, we presented Phase I data in cancer patients that supports our belief that CCX559 could be an important next-generation cancer treatment.

我們的現金餘額有所改善，在歐盟批准後，我們從Vifor獲得了4500萬美元的不可退還里程碑付款。憑藉3.718億美元的現金和投資，我們在本季末擁有了強勁的財務狀況，可以實現我們的既定目標。這些目標包括推進我們每日一次口服的新型PD-L1檢查點抑制劑CCX559的研發。在4月的美國癌症研究協會（AACR）會議上，我們展示了CCX559在癌症患者中的I期臨床試驗數據，這支持了我們對CCX559可能成為重要的下一代癌症治療藥物的信念。

We also resumed plans to advance TAVNEOS as a pipeline in a drug. We expect that communications with the FDA in late Q2 will yield next steps for lupus nephritis and severe hidradenitis suppurativa. As you can see, the start to the year is marked by what we call purposeful execution that has become a trademark of our success at ChemoCentryx.

我們也重啟了TAVNEOS藥物研發管線的推進計畫。我們預計，第二季末與FDA的溝通將為狼瘡性腎炎和重度化膿性汗腺炎的後續治療帶來進展。如您所見，新年伊始，我們秉持著「目標明確、執行到位」的理念，這已成為ChemoCentryx成功的標誌。

Moving now to Slide 4. As you know, we launched TAVNEOS in the United States in Q4 October of 2021. Today, we will review our key performance indicators for Q1 of this year. They tell us a simple, and I think, powerful story of growth and achievement. Specifically, in the first quarter, we achieved 248 new patient start forms, which is nearly double or 195% of the Q4 figure. We also attained over 300% of the Q4 number of patients on drug at 277 at March 31, and the number of unique prescribers nearly tripled by the end of Q1. We saw continued gains in the conversion rate of new patient start forms to patients on drug, surpassing our expectations at a very impressive 74% cumulative overall launch to date.

現在轉到投影片4。如您所知，我們於2021年10月第四季在美國推出了TAVNEOS。今天，我們將回顧今年第一季的關鍵績效指標。這些指標展現了一個簡單卻又極具感染力的成長與成就。具體來說，在第一季度，我們新增了248份患者起始表格，幾乎是第四季的兩倍，成長了195%。截至3月31日，我們的用藥患者數量達到277人，是第四季的300%以上；到第一季末，獨立處方醫生的數量幾乎增加了兩倍。我們看到新患者起始表格轉化為用藥患者的轉換率持續提升，迄今為止累計整體啟動轉換率已達到驚人的74%，超出了我們的預期。

Now a few words on the conversion rate. It must be noted that the conversion rate is a snapshot of a moment in time. This rate will never be a 100% because, for example, the simple fact that, after all, people who may have got referred to yesterday may not yet have filed their prescription. In addition, for other reasons, a relatively small percentage of folks never do fill their prescription of any meds. We do believe that this conversion rate number will continue to grow over time as it did Q1 over Q4, to a large majority percentage patients converting. And to be clear, 74% is a very good range by industry benchmarks at this stage of our launch.

現在來談談轉換率。必須指出的是，轉換率只是某個時刻的快照。這個轉換率永遠不會達到100%，因為，例如，昨天可能被轉診的患者可能還沒有提交處方。此外，由於其他原因，相對較少比例的患者從未配藥。我們相信，隨著時間的推移，這個轉換率會繼續成長，就像第一季對第四季的轉換率一樣，最終實現絕大多數患者轉換。需要明確的是，在我們推出服務的這個階段，74%的轉換率以產業基準來看是一個非常好的水準。

Ultimately, these indicators led to a U.S. net product sales of USD 5.4 million in the first quarter, more than 500%, the approximately USD 1 million we recorded in Q4. All these metrics exceed the projections that we had modeled internally this year. attained a robust and compelling picture that lead us to believe we are right where we need to be. Part of this growth picture reflects a stacking effect, which we believe will continue to build momentum in the upcoming quarters.

最終，這些指標推動我們第一季在美國實現了540萬美元的淨產品銷售額，較第四季約100萬美元的銷售額成長了500%以上。所有這些指標都超出了我們今年內部建模的預期。我們描繪出了一幅強勁而令人信服的圖景，讓我們相信我們正處於應有的水平。這一成長圖景部分反映了疊加效應，我們相信這種效應將在未來幾季繼續增強。

The first 2 components of this stacking effect, let's refer now to Slide 5, result from increasing new patients starting treatment and patients continuing their treatment and refilling their prescriptions. The third variable now overlaid on Slide 6 is an increase in the percentage proportion of paid patients. In the first quarter, this figure increased remarkably, reaching over 60% figure, which is beyond our projections at this stage.

這種疊加效應的前兩個組成部分（參見幻燈片5）源於開始接受治療的新患者數量以及繼續接受治療並續藥的患者數量的增加。投影片6上疊加的第三個變數是付費病患比例的提升。第一季度，這一數字顯著增長，達到了60%以上，超出了我們現階段的預測。

Why is 60% regarded as a very good number at this stage of our launch. Allow me to explain. First, paid patient percentage is, again, a snapshot of a moment in time. It will never be 100%. Why? Because at any given moment, you will have some patients participating in our patient support programs. These will subsequently shift to patients covered by payers. For example, our Quick Start program is available to patients prescribed TAVNEOS. So, they can access product without delay. This is provided for a limited time, typically 30 days. Quick Start is designed to provide medications to patients who need TAVNEOS, while reimbursement is sorted out with payers. And we'll note, of course, that such patient support programs are as expected and intelligent feature of an orphan drug specialty pharmacy distributed program.

為什麼在我們產品發布的這個階段，60% 被認為是一個非常好的數字？請容許我解釋一下。首先，付費患者比例只是某個特定時刻的縮影，永遠不會達到 100%。為什麼？因為在任何特定時刻，都會有一些患者參與我們的患者支持計畫。這些患者隨後會轉移到由付款人承保的患者。例如，我們的「快速啟動」計畫適用於處方 TAVNEOS 的患者。因此，他們可以立即獲得產品。該項目的期限有限，通常為 30 天。 「快速啟動」旨在為需要 TAVNEOS 的患者提供藥物，同時報銷事宜由付款人負責。當然，我們還需要指出的是，這類病患支援計畫是孤兒藥專科藥局分銷計畫的明智之舉，也是理所當然的。

What's important is that we anticipate that at steady state, percentage of paid patients will indeed be the large majority of patients on TAVNEOS. This is why we are very happy with where we are now, which is double where we were at the end of Q4. We expect the types of stacking effects described above, will continue to lead to an increasing percent of paid patients and importantly, increased revenues over time as the TAVNEOS launch matures. This is the momentum that we expect to propel TAVNEOS sales into the 10s and the hundreds of millions of dollars, then ultimately reaching what I believe will be a blockbuster status at its peak in the U.S. alone.

重要的是，我們預期在穩定狀態下，付費患者的比例將佔TAVNEOS治療患者的絕大多數。正因如此，我們對目前的狀況非常滿意，目前的比例是第四季末的兩倍。我們預計，上述疊加效應將持續推動付費患者比例的上升，更重要的是，隨著TAVNEOS的上市逐漸成熟，收入也將隨之成長。我們預計，這種勢頭將推動TAVNEOS的銷售額達到數千萬美元甚至數億美元，最終達到我認為僅在美國就將達到的轟動效應。

To drive the increase in new patient start forms reported this quarter, our commercial team has focused on the top prescribing physicians responsible for roughly 80% of all ANCA-associated vasculitis prescriptions in the United States and the majority of TAVNEOS referrals as referred to on Slide 7. We are seeing the results of this focus and execution paying off. During the first quarter, the number of unique prescribers grew to 281, nearly 3x what we reported in Q4. Moreover, the number of physicians writing prescriptions to more than one patient in their practice, that is repeat prescribers, has also increased markedly, nearly doubling from the last quarter.

為了推動本季度報告的新患者開立申請表數量的增長，我們的商業團隊重點關注了負責美國約80% ANCA相關性血管炎處方以及大部分TAVNEOS轉診的頂級處方醫生（如幻燈片7所示）。我們看到這種關注和執行的成果正在顯現。第一季度，獨立處方醫生數量增長至281人，幾乎是第四季度報告的三倍。此外，在診所內為多名患者開立處方的醫生（即重複處方醫生）數量也顯著增加，幾乎是上一季的兩倍。

To complement the individual outreach efforts, we also presented at key medical conferences in the first quarter, such as the International Society of Nephrology and the International Vasculitis and ANCA Workshop. We plan to continue our engagement with the scientific community at the European Renal Association meeting or ERA meeting, as well as the American Thoracic Society or ATS meeting later this month, followed by the European Alliance of Associations for Rheumatology or EULAR meeting in early June, among others.

為了補充個人推廣工作，我們也在第一季度參加了一些重要的醫學會議，例如國際腎臟病學會 (ISA) 和國際血管炎和抗中性粒細胞胞漿抗體研討會 (ANCA)。我們計劃在本月底的歐洲腎臟協會 (ERA) 會議、美國胸腔科學會 (ATS) 會議以及六月初的歐洲風濕病協會聯盟 (EULAR) 會議上繼續與科學界保持聯繫。

Let's now travel outside the U.S., as shown on Slide 8. TAVNEOS continues to gain traction with global regional approvals and launches in other parts of the world, led by our partner, Vifor Pharma and their sub-licenses. TAVNEOS was approved in the European Union in January and in Canada this April. Vifor recently initiated marketing activities for TAVNEOS in Germany and Austria during the first quarter and expects to launch in other markets this year. We anticipate these global regional sales to start to develop and we remind the community that Vifor will pay ChemoCentryx royalties in the teens to the mid-20% on total ex U.S. sales of one aggregate net sales line.

現在，讓我們來看看美國以外的市場，如幻燈片8所示。 TAVNEOS 繼續獲得全球區域性批准，並在世界其他地區上市，這得益於我們的合作夥伴 Vifor Pharma 及其授權子公司的推動。 TAVNEOS 於今年1月在歐盟獲得批准，並於今年4月在加拿大獲得批准。 Vifor 最近在第一季啟動了 TAVNEOS 在德國和奧地利的行銷活動，預計今年將在其他市場上市。我們預計這些全球區域性銷售將開始成長，並提醒大家，Vifor 將根據美國以外地區淨銷售額向 ChemoCentryx 支付 15% 至 20% 左右的專利費。

Moving on to clinical development on Slide 9. 2022 is shaping up to be an important year for our pipeline advancement. We will be communicating with regulators our plans to advance TAVNEOS in various indications beyond ANCA-associated vasculitis. This is part of our TAVNEOS pipeline and the drugs strategy. Shown on Slide 10, we are communicating with the FDA later this quarter, our plans for a development path for TAVNEOS in lupus nephritis. TAVNEOS' ability to selectively inhibit the C5a receptor without broad immunosuppression, offers new hope to lupus nephritis patients. We should have feedback midyear and hope to initiate our clinical work here during the second half of the year.

繼續第9張投影片上的臨床開發。 2022年將成為我們產品線推進的重要一年。我們將與監管機構溝通，推動TAVNEOS在ANCA相關性血管炎以外其他適應症的研發計畫。這是我們TAVNEOS產品線和藥物策略的一部分。第10張投影片展示了我們將在本季稍後與FDA溝通TAVNEOS在狼瘡性腎炎治療的研發路徑計畫。 TAVNEOS能夠選擇性抑制C5a受體，而無需廣泛的免疫抑制，這為狼瘡性腎炎患者帶來了新的希望。我們應該會在年中收到回饋，並希望在下半年啟動臨床工作。

Also later this quarter, as referenced on Slide 11, we plan to meet with the FDA to discuss a pivotal Phase III trial of TAVNEOS in patients with severe hidradenitis suppurativa or HS. At the upcoming May meeting of the Society for investigational Dermatology, we will present recent CCXI research that supports a more profound role of inflammatory mediators and neutrophil functions in severe forms of HS as compared to milder forms of the disease. And during the second half of this year, we intend to meet with the FDA to discuss our clinical trial results with TAVNEOS in the very rare orphan kidney disease of C3 glomerulopathy, a life-threatening disease with no currently approved therapies.

此外，如幻燈片11所述，我們計劃在本季度稍後與FDA會面，討論TAVNEOS在重度化膿性汗腺炎（HS）患者中開展的關鍵性III期臨床試驗。在即將於5月舉行的美國皮膚病研究學會（SDS）會議上，我們將展示CCXI的最新研究，該研究支持發炎介質和嗜中性球功能在重度HS中的作用比輕度HS更為顯著。此外，我們計劃在今年下半年與FDA會面，討論TAVNEOS在C3腎絲球病變（一種非常罕見的罕見腎臟疾病）的臨床試驗結果。 C3腎絲球病變是一種危及生命的疾病，目前尚無核准的治療方法。

Let us now turn to Slide 12. Our potent orally-administered PD-L1 inhibitor, CCX559, is currently being evaluated in a first-in-human Phase I dose escalation study in patients with advanced solid tumors. Can this small molecule revolutionized cancer care in a similar way or even beyond what approved monoclonal antibodies targeting this pathway have done? As shown on Slide 13, during the American Association for Cancer Research Meeting this past April, we presented pharmacokinetic or PK, as well as pharmacodynamic or PD data on the first set of patients enrolled in our Phase I basket study. These patients had received CCX559 orally given once daily at doses of 30, 60 and 120 milligrams.

現在我們翻到幻燈片12。我們強效口服PD-L1抑制劑CCX559目前正在進行一項針對晚期實體腫瘤患者的首次I期劑量遞增臨床試驗。這種小分子藥物能否像已核准的標靶該路徑的單株抗體一樣，甚至超越其帶來的影響，徹底改變癌症治療？如投影片13所示，在今年4月的美國癌症研究協會年會上，我們展示了參與I期籃子研究的首批病患的藥物動力學（PK）和藥效動力學（PD）數據。這些患者每日口服CCX559一次，劑量分別為30、60和120毫克。

The AACR poster supported PK properties that were in line with our preclinical projections, along with strong PV evidence of immune cell activation in cancer patients dosed with CCX559. Specifically, we found the following: evidence of very good oral absorption of CCX559 and in a dose proportional fashion. Evidence of pharmacological activity in all those tests evidence that the 120 mg once a day dose is therapeutically relevant. Reproducible evidence for immune system activation, including so-called Th1 responses, which are known to be correlated with antitumor efficacy at the 120 mg once daily dose and a very good tolerability profile of the drug.

AACR海報證實了與我們的臨床前預測一致的藥物動力學特性，以及強有力的藥效學證據，顯示接受CCX559治療的癌症患者免疫細胞被活化。具體而言，我們發現：CCX559口服吸收良好，且與劑量成比例。所有試驗中的藥理活性證據均表明，每日一次120毫克的劑量具有治療相關性。免疫系統活化的證據可重複，包括所謂的Th1反應，已知Th1反應與每日一次120毫克劑量的抗腫瘤療效相關，且該藥物具有非常好的耐受性。

We expect to report further clinical findings throughout the year, starting with the American Society of Clinical Oncology or ASCO meeting in June. At ASCO, we intend to describe some findings of what have been called immune response-related adverse events or IRAEs in the trial to date, which are, in fact, a good sign with immune cell checkpoint inhibitors and well known to correlate with effective antibody-based checkpoint inhibitor currently approved for cancer therapy.

我們預計在今年內報告更多臨床發現，首先是6月的美國臨床腫瘤學會（ASCO）會議。在ASCO，我們計劃描述迄今為止試驗中被稱為免疫反應相關不良事件（IRAE）的一些發現，這些發現實際上是免疫細胞檢查點抑製劑的良好信號，並且眾所周知，它們與目前已獲批用於癌症治療的有效抗體型檢查點抑製劑存在相關性。

Also, while noting that many of the tumor types in the present dose escalation trial do not involve the PD-L1/PD-1 pathway, which is typical of the basket design of early cancer studies, we also intend to relate any early impressions of relevant patients whose disease may have stabilized, while up-taking CCX559, notwithstanding the very advanced nature of their illness. Such observations will be instrumental in designing the next steps in the clinical development of this very important program and expanded Phase 1B-2 clinical trial, which we intend to start in the second half of this year.

此外，儘管我們注意到，本劑量遞增試驗中的許多腫瘤類型不涉及PD-L1/PD-1通路（這是早期癌症研究籃式設計的典型特徵），但我們仍打算分享一些相關患者的早期印象，這些患者在接受CCX559治療後病情可能已經穩定，儘管他們的病情已經非常晚期。這些觀察結果將有助於設計這項極為重要的項目和擴展的1B-2期臨床試驗的後續臨床開發步驟，我們計劃於今年下半年啟動試驗。

With all of these ongoing activities, let's not forget financial strength in these tumultuous times. We are fortunate to be in a strong financial position, ending the first quarter with USD 371.8 million in cash investments. This balance reflects a USD 45 million nonrefundable milestone payment from Vifor following the EU approval of TAVNEOS. Purely as a matter of ASC 606 accounting standards, the payment will be recognized as collaboration revenue over an estimated 4-year period, subject to adjustment from time to time. We understand this nuance may be of particular interest to our friends in the retail investment community.

在所有這些持續開展的活動中，我們不應忘記在動盪時期保持財務實力。我們很幸運，財務狀況良好，第一季末的現金投資額為3.718億美元。這筆餘額反映了Vifor在歐盟批准TAVNEOS計畫後支付的4,500萬美元不可退還的里程碑付款。根據ASC 606會計準則，該付款將在預計4年的期間內確認為合作收入，並可能不時進行調整。我們瞭解，這種細微的差別可能會引起散戶投資界朋友的特別注意。

With that, the floor is yours, Susan?

那麼，蘇珊，該你發言了？

Thank you, Tom. Our first quarter 2022 financial results were included in our press release today and are summarized on Slide 14. TAVNEOS U.S. net product sales were approximately USD 5.4 million for the first quarter ended March 31, 2022, more than 5x the approximate USD 1 million reported in the fourth quarter of 2021. Collaboration revenue was USD 0.1 million for the first quarter of 2022 compared to USD 10.2 million for the same period last year.

謝謝你，湯姆。我們2022年第一季的財務表現已包含在今天的新聞稿中，並在第14張投影片中進行了總結。截至2022年3月31日的第一季度，TAVNEOS在美國的淨產品銷售額約為540萬美元，是2021年第四季約100萬美元銷售額的5倍多。 2022年第一季的合作收入為10萬美元，而去年同期為1,020萬美元。

The decrease in collaboration revenue was attributable to the USD 10 million milestone received from Vifor in 2021 for the acceptance of the Japanese NDA for TAVNEOS in the treatment of ANCA-associated vasculitis. In accordance with ASC 606, collaboration revenue is recognized ratably in proportion to actual costs incurred as a percentage of total program budgeted costs, as we complete our performance obligation under the avacopan agreement with Vifor. The USD 45 million nonrefundable regulatory milestone received upon TAVNEOS approval in Europe is indeed reflected in our Q1 balance sheet, but will be recognized as collaboration revenue, distinct from product sales over an estimated 4-year period subject to periodic adjustments.

合作收入的減少歸因於Vifor於2021年收到的1000萬美元里程碑款項，該款項用於TAVNEOS在日本獲得NDA批准，用於治療ANCA相關性血管炎。根據ASC 606，隨著我們完成與Vifor簽訂的avacopan協議項下的履約義務，合作收入將按實際發生成本佔專案預算總成本的百分比按比例確認。 TAVNEOS在歐洲核准後收到的4,500萬美元不可退還的監管里程碑款項確實已反映在我們的第一季資產負債表中，但將確認為合作收入，與預計4年期間的產品銷售額不同，並會定期進行調整。

Cost of sales for the first quarter ended March 31, 2022, was USD0.2 million. As a reminder, costs incurred for manufacturing campaigns initiated prior to the October 2021 FDA approval of TAVNEOS recorded as research and development expense. Accordingly, cost of sales in the near term is expected to be lower than in later periods until we clear through the preapproval of inventory.

截至2022年3月31日的第一季銷售成本為20萬美元。需要提醒的是，在2021年10月FDA核准TAVNEOS之前啟動的生產活動所產生的成本計入研發費用。因此，預計短期銷售成本將低於後期，直至我們完成預批庫存清倉。

Research and development expenses were USD 17.5 million for the first quarter of 2022 compared to USD 23.4 million for the same period in 2021. This decrease was primarily attributable to manufacturing costs of commercial drug supply in the first quarter of 2021, along with lower clinical trial expenses. Selling, general and administrative expenses were USD 26 million for the first quarter of 2022 compared to USD 16.3 million in the same period in 2021. The increase was primarily due to higher employee-related expenses and professional fees, including those associated with the TAVNEOS U.S. launch and commercialization.

2022年第一季研發費用為1750萬美元，而2021年同期為2,340萬美元。這一下降主要歸因於2021年第一季商業藥品供應的製造成本以及臨床試驗費用的降低。 2022年第一季銷售、一般及行政費用為2,600萬美元，而2021年同期為1,630萬美元。這一增長主要歸因於員工相關費用和專業費用的增加，包括與TAVNEOS在美國上市和商業化相關的費用。

Net loss for the first quarter of 2022 was USD 38.6 million compared to net loss of USD 29.7 million for the same period last year. Total shares outstanding as of March 31, 2022, were approximately 71.1 million shares. Lastly, we ended the quarter with cash, cash equivalents and investments totaling approximately USD 371.8 million as of March 31, 2022, which includes the USD 45 million milestone previously discussed. Tom?

2022年第一季淨虧損為3,860萬美元，而去年同期淨虧損為2,970萬美元。截至2022年3月31日，公司流通股總數約7,110萬股。最後，截至2022年3月31日，我們本季末的現金、現金等價物及投資總額約為3.718億美元，其中包括先前討論過的4,500萬美元的里程碑。湯姆？

Thank you, Susan. Moving to Slide 15. This has been an excellent start to 2022, an excellent start. To summarize, TAVNEOS net product sales increased more than 5-folds. And we outperformed our own expectations for Q1 on each of our key performance indicators, including new patient start forms, patients on drug, unique prescribers and repeat prescribers. Outside the U.S., there were approvals in the EU and Canada, along with commercial launches by our partner, Vifor Pharma, in Germany and Austria.

謝謝Susan。請移至第15張投影片。這是2022年的良好開端，非常好。總而言之，TAVNEOS的淨產品銷售額成長了5倍以上。我們第一季的各項關鍵績效指標均超出預期，包括新患者起始表格、用藥患者、獨立處方者和重複處方者。在美國以外，該藥物在歐盟和加拿大獲得了批准，我們的合作夥伴Vifor Pharma也在德國和奧地利進行了商業上市。

We expect to interact with the FDA later this quarter to discuss plans of lupus nephritis and severe hidradenitis suppurativa with clinical trial initiations for both indications planned during the second half of the year. We also plan to meet with the FDA later this year to discuss C3 glomerulopathy. The early data from our first human studies provide evidence of the benefits that are once daily, orally administered PD-L1 inhibitor, CCX559, could bring to cancer care. We expect to present more data and initiate an expanded trial later this year.

我們預計將於本季稍後與FDA溝通，討論狼瘡性腎炎和嚴重化膿性汗腺炎的治療計劃，並計劃於今年下半年啟動針對這兩種適應症的臨床試驗。我們也計劃於今年稍後與FDA會面，討論C3腎絲球病變的治療方案。我們首批人體研究的早期數據證明了每日一次口服PD-L1抑制劑CCX559可能為癌症治療帶來的益處。我們預計今年稍後提供更多數據並啟動一項擴展試驗。

And we have the financial engine to drive forward on all these fronts with confidence. I alluded to tumultuous market times in this ecosystem that is biopharma, I guess it's worth reminding ourselves that sometimes conditions must vary themselves deep before they bloom. The advantage here at ChemoCentryx in my view, is great science, has already germinated into a great medicine. Rest assured, we intend to continue to grow and harvest a tough, bountiful and bright bumper crop, our garden of innovation.

我們擁有雄厚的財務實力，能夠滿懷信心地在所有這些方面繼續前進。我之前提到過生物製藥生態系統的市場動盪時期，我想我們應該提醒自己，有時環境必須經歷深刻的變革才能開花結果。在我看來，ChemoCentryx 的優勢在於其卓越的科學技術，它已經發展成為一種偉大的藥物。請放心，我們將繼續培育，收穫堅韌、豐饒、燦爛的豐收，這是我們創新的花園。

With that, I'll thank you all very much and turn the call over to the operator for your questions.

最後，我要向大家表達衷心的感謝，並將電話轉給接線生回答大家的問題。

(Operator Instructions) Your first question comes from the line of Joseph Schwartz.

（操作員指示）您的第一個問題來自約瑟夫施瓦茨。

Congratulations on the strong launch. I was wondering if there was any inventory stocking in the quarter and if you can give us a sense of the proportion of patients on drugs that were paid as of the end of the first quarter? And then I have a follow-up.

祝賀您強勁上市。我想知道本季是否有庫存儲備？您能否告訴我們，截至第一季末，已付款的患者佔比是多少？然後我還有一個後續問題。

Sure, Joe. So the inventory stocking is not a big feature of what we're talking about. Each quarter, you should expect a limited channel supply for our agreements with specialty distributors and specialty pharmacies selling TAVNEOS, but they typically maintain approximately 2 weeks supply on hand in line with other rare disease products. As I may have alluded to, as of March 31, 277 patients on drug, of which approximately 60% were on paid medication. So that's a significant end model. I think we're very happy with the model that's performing, modeled uptick from where we were in Q4.

當然，喬。所以庫存備貨並不是我們討論的重點。每個季度，我們與銷售TAVNEOS的專業經銷商和專業藥房達成的協議通路供應量應該有限，但他們通常會保持大約兩週的庫存，與其他罕見疾病產品一樣。正如我可能提到的，截至3月31日，共有277名患者在用藥，其中約60%的患者使用付費藥物。所以這是一個重要的終端模型。我認為我們對目前模型的表現非常滿意，它模擬了第四季度的上升趨勢。

Great. That's super helpful. And then can you provide any additional color on the real world pricing of TAVNEOS? How should we be thinking about the price on a gross and net basis?

太好了。這太有幫助了。那麼，您能否進一步解釋一下TAVNEOS的實際定價呢？我們應該如何根據總價和淨價來計算價格？

Yes. We're still quite early in the launch, but our goal has been to increase, especially education about TAVNEOS, how to get it to patients, certainly get people into the program through quick start, et cetera. We're also working very carefully leveraging patient support group programs that we've implemented to help again appropriate patient access to treatment, while working through the reimbursement process. All those things are going really well And I think we're right where we were modeled to be, in fact, exceeding our models.

是的。我們仍處於啟動初期，但我們的目標是加強，尤其是關於 TAVNEOS 的教育，如何將其推廣給患者，當然也包括透過快速啟動等方式讓人們加入該計畫。我們也非常謹慎地利用我們已實施的患者支持小組項目，以幫助患者再次獲得合適的治療，同時順利完成報銷流程。所有這些工作都進展順利，我認為我們已經達到了預期目標，事實上，甚至超出了我們的預期。

So our wholesale acquisition cost for a 30-day supply is USD14,450. And you know we've said before, this, we believe, reflects the value and is certainly in line with rare disease pricing. We will talk a little bit more about the overall gross to net discussions as the launch matures a bit more. We're also sensitive to the fact that gross to net means different things to different people. So, as we are able to, again, mature the launch and be able to talk globally about that concept, we'll be happy to do so.

因此，我們30天供應量的批發採購成本為14,450美元。您知道我們之前說過，我們相信這反映了價值，並且肯定符合罕見疾病的定價。隨著產品發布的進一步成熟，我們將進一步討論整體毛利/淨利比的討論。我們也意識到，毛利/淨利比對不同的人來說意味著不同的東西。因此，當我們能夠再次完善產品發布，並能夠在全球範圍內討論這一概念時，我們很樂意這樣做。

But I'll just stress again, through March, the percent of paid patients on drug jumped substantially to 60%. And I was quoted at the end of Q4, as saying they were over one-third were paid drug. So as you can see, we're making great strides there. And again, right where we're modeled, where we would like to be. And it's taking an average of less than 4 weeks or so to reach payer approval. So, all the metrics in our model going in the right direction, in fact, either right on or exceeding our expectations at this point.

但我還是要再次強調，截至3月份，付費用藥患者的比例大幅躍升至60%。據我在第四季末所說，超過三分之一的患者獲得了付費用藥。所以，如您所見，我們在這方面取得了長足的進步。而且，我們完全達到了模型設定的目標，也達到了我們所期望的目標。平均只需不到4週左右就能獲得付款方批准。所以，我們模型中的所有指標都在朝著正確的方向發展，實際上，目前要不是符合我們的預期，就是超出了我們的預期。

Your next question comes from the line of Steve Seedhouse from James Raymond -- sorry Raymond James.

您的下一個問題來自詹姆斯·雷蒙德 (James Raymond) 公司的史蒂夫·西德豪斯 (Steve Seedhouse)——對不起，雷蒙德·詹姆斯 (Raymond James)。

This is Ryan Deschner on for Steve Seedhouse. Congratulations on the launch so far. I wanted to ask if you could provide any additional detail on sales guidance for the year or at least how growth trends have continued through April and May thus far? I have a follow-up.

我是 Ryan Deschner，為 Steve Seedhouse 做報告。恭喜您迄今為止的發布。我想問一下，您能否提供一些關於今年銷售預期的更多細節，或者至少介紹一下截至目前4月和5月的成長趨勢如何？我還有一個後續問題。

Well, we are -- again, we're really keen on focusing on our key performance metrics and showing increase quarter-by-quarter. I believe, fundamentally, we've got a very strong launch going now. I think those trends will continue. Today, we're really hyper-focused on the great first quarter that we posted. Again, we're extremely pleased with the nearly -- or actually more than 5x increased revenues to USD 5.4 million. We were very pleased that new patient start forms grew to 248, nearly twice what they were at the end of Q4. We were extremely pleased with the 277 people on drug -- patients on drug 3 times what we reported in Q4, and we nearly tripled the number of unique prescribers and doubled -- I'm sorry, the number of unique prescribers, yes, nearly tripled and we nearly doubled the repeat prescribers.

嗯，我們——再次強調，我們非常熱衷於關注我們的關鍵績效指標，並逐季度實現成長。我相信，從根本上來說，我們現在的啟動非常強大。我認為這些趨勢將會持續下去。今天，我們高度關注我們發布的出色第一季業績。再次強調，我們對營收成長近五倍（實際上成長了五倍多）至540萬美元感到非常高興。我們非常高興的是，新患者開始表格增長到248份，幾乎是第四季末的兩倍。我們對277名用藥患者感到非常滿意——用藥患者的數量是我們第四季度報告的三倍，我們的獨立處方者數量幾乎增加了兩倍，並且——抱歉，是獨立處方者的數量，是的，幾乎增加了兩倍，我們的重複處方者數量也幾乎增加了一倍。

Now I underscore all those points because, again, it shows you our launch plan, our trajectory and where we intend to keep this launch going over time. So, you can expect quarterly calls to report quarter-to-quarter. We'll be able to update you on all these metrics and we'll be happy to provide details on the upcoming quarter on our next call. So all I can say is, again, strong launch, good trajectory, we're feeling very strong about where we are, very good about where we are.

現在我強調所有這些要點，因為它們再次展現了我們的發布計劃、發展軌跡以及我們計劃如何持續推進這項發布。因此，您可以期待季度電話會議逐季度報告。我們將能夠向您通報所有這些指標的最新情況，並很樂意在下次電話會議上提供下一季的詳細資訊。所以我只能說，我們發布了強勁的業績，發展軌跡良好，我們對目前的狀況感到非常滿意。

Great. And just one more quick one. I was wondering how patient persistence has been looking like so far? I know you finding patients staying on through remission and beyond?

太好了。還有個快速問題。我想知道到目前為止，患者的堅持情況如何？我知道你們發現有病人撐到緩解期甚至更久嗎？

Well, it's still -- it's early days, so we don't have a lot of data. But what we can tell you is this, the health care providers and indeed many of the sophisticated parts of the patient population are very aware of the data that we published in our advocate pivotal trial. They're super aware that we demonstrated that TAVNEOS was superior in sustaining remission over the standard of care and durable remission up to 52 weeks. So, I think that we have seen a great deal of interest in keeping people on therapy as long as they're benefiting from the drug and tolerating the drug very well.

嗯，現在還處於早期階段，所以我們沒有太多數據。但我們可以告訴你的是，醫療保健提供者以及許多經驗豐富的患者群體都非常了解我們在倡導者關鍵試驗中發表的數據。他們非常清楚，我們證明了TAVNEOS在維持緩解方面優於標準治療，並且可持續緩解長達52週。所以，我認為，我們看到人們對繼續接受治療非常感興趣，只要患者能夠從藥物中獲益並且耐受性良好。

And as again, the usage matures over this first year, we're going to see, again, what the real-world data is telling us. But I haven't heard of any movements at this point to do only short-term therapy. In fact, quite the opposite, Most of the discussions we've been having are how long should people stay on therapy. Again, we quote from our blinded data in our trial, which was a long trial, frankly, IN a disease like this, and we point to any publications in the literature about extended compassionate use programs and so on, which go out to some degree farther than 12 months. But right now, too early to say from real-world data post launch.

隨著第一年使用情況的逐漸成熟，我們將再次觀察真實世界數據。但目前我還沒聽說任何只進行短期治療的動向。事實上，恰恰相反，我們一直在討論的重點是病人應該接受多長時間的治療。我們引用了我們試驗中的盲法數據，坦白說，這是一項針對此類疾病的長期試驗，我們也參考了文獻中關於延長同情用藥計劃等的出版物，這些計劃的期限在某種程度上超過了12個月。但現在，根據啟動後的真實世界數據來下結論還為時過早。

Your next question comes from the line of Yanan Zhu from Wells Fargo.

您的下一個問題來自富國銀行的朱亞南。

And I wanted to add my congratulations to a great launch momentum. Indeed, our doctor check has shown that doctors do like the drug and are satisfied with the use. And great to see that it's reflected in these strong numbers in this quarter. I wanted to ask about the growth question from maybe another perspective. I think in January, with the number you provided -- in January, there were about 50 new patient start forms. Given that you now have roughly 250 new patient start forms for the core quarter, that really means that February and March delivered phenomenally better number -- greater number than January. I wanted to ask how are those numbers distributed between February and March?

我想對這款藥物的良好上市勢頭表示祝賀。事實上，我們的醫生調查顯示，醫生確實喜歡這款藥物，並且對其使用感到滿意。很高興看到這反映在本季強勁的數據中。我想從另一個角度問成長問題。根據您提供的數據，我認為1月大約有50份新病患入院申請表。考慮到您目前核心季度大約有250份新患者入院申請表，這意味著2月和3月的數據明顯好於1月——比1月更多。我想問一下，這些數字在2月和3月之間的分佈如何？

And if there is a line of increase, like, for example, 50 then 80 then 120, and that will add up to roughly 250, but that would give a line of increase of -- from 80 to 120. And obviously, in April, it could be on that rate, that will be -- continue to be of great increase. So, obviously, you have insight to April numbers. So, I just want to overall ask you the growth perspective because the other possibility is February and March have similar numbers, those 100, and that will point to a different picture So Tom, to any extent if possible, could you talk about your confidence for continuing to grow this new patient add number?

如果有一條增長線，比如說，50、80、120，加起來大約是250，但這會形成一條從80到120的增長線。顯然，4月份可能會按照這個速度繼續大幅成長。所以，顯然你對4月的數據有所了解。所以我只想從整體成長角度問你一個問題，因為另一個可能性是2月和3月的數字相似，都是100，這將指向不同的圖像。所以，湯姆，如果可能的話，你能不能談談你對繼續增加新增患者數量的信心？

Yanan, yes, I'm confident. Look, our model obviously suggests that we continue to increase quarter-on-quarter until we get to peak. And make no mistake, I've said this publicly. I'll say it again. I believe at peak in the United States alone, in ANCA vasculitis alone, this drug has blockbuster potential. So obviously, we need to show growth quarter-by-quarter. The growth will be shown both with new patient starts, patient on drug, paid patient percentage should continue to increase, as I said in my remarks, until the large majority of folks are on paid patients. And those stacking effects that I alluded to in the 2 slides in the deck that I showed, will contribute to the growth curve as well.

亞南，是的，我很有信心。你看，我們的模型顯然表明，我們的藥物銷售額將持續逐季成長，直到達到高峰。別誤會，我已經公開說過了，我還會再說一次。我相信，光是在美國，在ANCA血管炎領域，這種藥物的高峰就具有重磅炸彈級潛力。所以，顯然，我們需要逐季顯示成長。這種增長將體現在新增患者數量、用藥患者數量以及付費患者比例的持續增長上，正如我在發言中所說，直到絕大多數患者都成為付費患者。我在簡報的兩張投影片中提到的疊加效應，也將有助於成長曲線。

We presented the January data almost out of a, I don't know, a sense of thoroughness and courtesy to the investment community. We realize that, that kind of data can be misunderstood, misinterpreted. So, we won't be doing that anymore. We're going to present quarter-by-quarter data and we believe that's the appropriate way to talk about the launch. But I am very confident again of our model, of our growth curves and the fact, as you mentioned at the top of your remarks, physicians are giving very positive feedback on this drug as our patients. So it is finding its niche and we're going to continue to find ways to make sure it finds its niche with all appropriate patients as we go forward and that will lead us eventually to blockbuster potential.

我們公佈1月的數據，幾乎是出於一種……我不知道，一種對投資界的全面和禮貌。我們意識到，那種數據可能會被誤解和曲解。所以，我們不會再這樣做了。我們將公佈逐季的數據，我們相信這是談論此次上市的合適方式。但我對我們的模型、我們的成長曲線以及事實再次充滿信心，正如您在發言開頭提到的，醫生和患者對這款藥物的反饋非常積極。所以它正在找到自己的市場定位，我們將繼續尋找方法，確保它在所有合適的患者群體中找到自己的市場定位，最終將引領我們走向重磅藥物的潛力。

Great to hear those remarks. And I also wanted to ask about the insurance coverage situation. Of course, you have a great number of -- proportion of patients now on paid drug. However, I was wondering could another growth be actually a broader payer coverage because even though now you have 60 patients on paid insurance plans, but doctors may have only given you the patients that they know have good insurance.

很高興聽到這些評論。我還想問問保險覆蓋情況。當然，現在有很多病人在用付費藥物。但是，我想知道另一個增長點是否實際上是更廣泛的支付方覆蓋，因為即使現在有60名病人在用付費藥物，但醫生可能只會給那些他們知道有良好保險的病人看病。

So, there could be a potential if the insurance coverage broaden, doctors will have even more patients to write the drug for. Because I think even though you have a free month -- one month free supply, doctors think more holistically, and they think about this is a long-term treatment, they probably -- some of them wouldn't start without having the insurance line up. So my question to you is what is the current insurance coverage? And how do you see that evolve? At peak, what kind of insurance coverage could we get? Or I wanted to add one more small question there. That is, have you been seeing pushback like the price is too high, seems like that from the insurers?

因此，如果保險覆蓋範圍擴大，醫生可能會有更多患者需要開藥。因為我認為，即使有一個月的免費藥量，醫生也會考慮得更全面，認為這是一種長期治療，他們中的一些人可能——如果沒有保險，就不會開始用藥。所以我的問題是，目前的保險保障範圍是多少？您認為這種情況會如何發展？在高峰期，我們能獲得什麼樣的保險保障？或者我想再補充一個小問題。也就是說，您是否看過保險公司對價格過高之類的反對意見？

Great. Yes, very important issues. And you're so right, at this point, what really matters is that physicians not only think the drug is very good, very powerful, but they're also having success in getting patients on treatment, the obtaining of prior authorizations and in some cases, where necessary, even successful appeals, all of that's been going a lot better and we'll continue to get smoother as we get through the process of additional payer discussions. I mean we're very pleased that on average, it's taking 4 weeks or less to reach payer approval. That's an improvement over the 4 to 6 weeks we noticed in Q4 that I reported at that time. So again, that trend is going really well.

太好了。是的，非常重要。您說得對，目前真正重要的是，醫生們不僅認為這種藥物非常好，非常有效，而且他們還成功地讓患者接受了治療，獲得了預先授權，在某些情況下，甚至在必要時成功上訴。所有這些都進展順利，隨著我們完成更多付款人談判的流程，我們的進程將會更加順暢。我很高興看到，平均而言，獲得付款人批准的時間在4週或更短。這比我當時報告的第四季的4到6周有所改善。所以，這種趨勢確實發展得很好。

Frankly, what we're doing, and I think the discussion with payers have been productive. Again, then the initial feedback from physicians suggest that they are getting success in obtaining reimbursement for appropriate patients who meet the criteria outlined in the label. So, I think that the -- you're quite correct. We continue to work month by month with payers. We continue to bring more online each quarter and we'll continue to do so. And by the end of this year, I am quite convinced that we'll have the majority of folks covered under paid insurance in a pre-authorized way with published, established, preauthorization criteria, et cetera.

坦白說，我們正在做的，以及我認為與付款方的討論都是富有成效的。再次強調，醫生的初步回饋表明，他們正在成功地為符合標籤所列標準的合適患者獲得報銷。所以，我認為──你說得很對。我們將繼續逐月與付款方合作。我們每季都會繼續上線更多服務，我們將繼續這樣做。到今年年底，我確信，我們將透過預先授權的方式，透過公佈的、既定的預先授權標準等等，讓大多數人享受付費保險的保障。

So those have been very productive. We'll be talking more about the numbers as we go forward this year. But I think we're pretty pleased even with where we are now in getting both coverage and importantly, reimbursement for these folks.

所以這些工作非常有成效。今年我們會進一步討論具體數字。但我認為，即使對於目前為這些患者提供的保障以及重要的報銷，我們也相當滿意。

Your next question comes from the line of Dae Gon Ha from Stifel.

您的下一個問題來自 Stifel 公司的 Dae Gon Ha。

My congrats on the profound quarter, congrats. I'll leave a lot of the commentary to you guys and go quick to the question. Two questions from me. One on the unique prescribers being 281. Can you maybe give us a little bit more color on the disposition of those as it pertains to the top specialists in the U.S. of approximately 400 versus the community specialists of the 3,000 number that you gave in your slide? And secondly, we did a survey and it seems like things seem to be improving with COVID abating. But I just wanted to kind of get a sense for how we should think about as we enter the summer months and COVID seems to be abating, but in fluxes, different geographies seem to be implementing different policies. So how should we think about that?

恭喜本季取得如此顯著的成績，恭喜！很多評論留給大家，現在直接進入正題。我有兩個問題。一個是關於獨立處方醫生的數量，目前是281人。您能否詳細介紹一下這些醫生的配置情況，例如美國頂級專科醫生約有400人，而您在幻燈片中提到的社區專科醫生有3000人。其次，我們做了一項調查，隨著新冠疫情的減弱，情況似乎有所改善。但我想了解一下，隨著夏季的到來，新冠疫情似乎有所減弱，我們該如何看待這個問題。然而，在不斷變化的情況下，不同地區似乎正在實施不同的政策。那麼，我們該如何看待這個問題呢？

It's a very good set of questions, important questions. What we're doing right now is we're clearly trying to focus intensively on those top 400. But we're really looking holistically at the additional 3,000 community specialists that make up 80% of the market overall. So, we're seeing a growing number of unique prescribers and referrals coming from both the academic centers of excellence, where most of the 400 specialists reside, as well as the community specialists still. So, it's clearly within that 3,400 where we're finding most of the action right now, which is encouraging.

這是一系列非常好的問題，非常重要。我們目前正在做的，顯然是努力集中精力於這400位頂尖專家。但我們實際上也在全面關注另外3000名社群專家，他們佔了整個市場的80%。因此，我們看到越來越多的獨立處方醫生和轉診醫生來自學術卓越中心（這400名專家中的大多數都在那裡），也來自社區專家。所以，很明顯，目前我們發現大部分的行動都集中在這3400名專家身上，令人鼓舞。

Now you're so right about COVID. I mean, the centers of excellence in January were largely not excessive. In fact, our in-person visitations across the board from medical science liaisons and sales reps, dipped to under 40%. We were able to get that to be above 60% in recent times. So, we're moving in the right direction. And that, we believe, will open up more of the prescribing potential again at the centers of excellence, where most of the 400 of the KOLs prescribe.

您對新冠疫情的看法非常正確。我的意思是，1月卓越中心的人員數量基本上沒有過高。事實上，我們所有醫學科學聯絡員和銷售代表的現場訪問率都下降到了40%以下。最近我們成功地將這比例提高到了60%以上。所以，我們正朝著正確的方向前進。我們相信，這將再次釋放卓越中心的更多處方潛力，400位關鍵意見領袖中的大多數都在這些中心開處方。

We're seeing a healthy number of those doing very good work with -- in the KOL population, the top 400. But as we get more access, we can discuss with them more directly the program, do more medical education and quite frankly, help them understand how to ease their offices access to getting the patients the drug, I think that's going to accelerate even more now that those centers are opening up.

我們看到，在 KOL 人群中，前 400 名中有很多做得非常好。但隨著我們獲得更多訪問權限，我們可以更直接地與他們討論該計劃，進行更多的醫學教育，坦率地說，幫助他們了解如何讓他們的辦公室更容易地讓患者獲得藥物，我認為現在這些中心正在開放，這將會進一步加速。

Your next question comes from the line of Anupam Rama from J.P. Morgan.

您的下一個問題來自摩根大通的 Anupam Rama。

And congrats on the good early start to the launch here. Two quick ones. The first one following on the last question, the 281 prescribers, can you give us a sense of the breakdown between, say, nephrologists, rheumatologists, other physicians? And then second question, on your cash position, are you expecting any more milestones in 2022? And what is your current cash position sufficient to? And what does it assume?

恭喜你們的發布會開局良好。我快速問兩個問題。第一個問題緊接著最後一個問題，281位處方醫生，您能否大致介紹一下腎臟科、風濕病科和其他醫生的細分情況？第二個問題，關於你們的現金狀況，你們預計2022年還會有更多里程碑嗎？你們目前的現金狀況足以支撐什麼？假設什麼？

Sure thing. Anupam. I'll take the first part of the question, and I'll put the second part over to Susan Kanaya. So, with the prescribing physicians, the breakdown is interesting. It's about 60 -- a little over 60% rheumatologists, maybe about 25% nephrologists. I'm going to put an asterisk by this distribution in a moment for rheums and nephrologists and 15% other where other includes pulmonologists and ENT specialists and that kind of thing. So, that shifted a little bit from what we talked about in Q4, but not that much.

當然可以。 Anupam。我來回答問題的第一部分，第二部分交給Susan Kanaya。開處方的醫生的分佈很有意思。大約有60%——略高於60%是風濕病科醫生，大概有25%是腎臟科醫生。我一會兒會在這個分佈旁邊打個星號，表示風濕病和腎臟科醫生，15%是其他醫生，包括肺病科醫生、耳鼻喉科醫生等等。所以，這與我們在第四季度討論的情況略有不同，但差異不大。

Now the thing the asterisk I was referring to is that we're finding more and more that a lot of these folks are seen both by a rheumatologist, who can really be considered their primary care physician and by a nephrologist when they develop kidney manifestations. So, they'll see the nephrologists, they may even decide to get on TAVNEOS as a consequence of declining kidney function. But oftentimes, in the team care approach, the rheumatologists will actually write the prescription. So it's -- we're still trying to dig a little bit deeper and where the actual motivation for the referrals come from. But it is, generally speaking, again, about 80% to 85% rheumatologists and nephrologists prescribing the bulk of TAVNEOS right now and 15% other. As regards our cash position of USD 371.8 million in cash and cash equivalents, I will put that back to Susan Kanaya. Susan?

我之前提到的星號指的是，我們越來越多地發現，很多患者既會去看風濕病專科醫生（風濕病專家實際上可以被視為他們的初級保健醫生），也會去看腎病專科醫生（當他們出現腎臟症狀時）。所以，他們會去看腎臟科醫生，甚至可能因為腎功能下降而決定使用TAVNEOS。但在團隊照護模式中，風濕病專家通常會開處方。所以我們仍在努力深入探究轉診的真正動機。但總的來說，目前大約80%到85%的風濕病專科醫生和腎臟科醫生開出了大部分TAVNEOS，其他醫生佔15%。至於我們3.718億美元的現金和現金等價物，我想把這個數字轉交給Susan Kanaya。 Susan？

Thanks, Tom, and thanks for your question, Anupam. So outside of the USD 45 million milestone that we reported today, we don't anticipate any significant additional milestones in 2022. However, we'll be eligible, of course, to receive our royalties in the teens to mid-20s on the Vifor territory aggregate net sales. In addition, I'll remind you that there are approximately USD 295 million in potential aggregate milestones upon reaching certain annual net sales thresholds under our agreement. So, again, very well positioned today with the USD 371.8 million that we've reported and believe that our reserves put us in a very strong position to execute across our commercial and clinical strategy that we discussed today.

謝謝湯姆，也謝謝你的提問，阿努帕姆。除了今天報告的4500萬美元里程碑之外，我們預計2022年不會再有任何重大里程碑。不過，我們當然有資格獲得Vifor地區總淨銷售額在十幾到二十五美元左右的特許權使用費。此外，我要提醒大家，根據我們的協議，在達到某些年度淨銷售額門檻後，我們可能會獲得約2.95億美元的總里程碑。因此，憑藉我們報告的3.718億美元的銷售額，我們目前處於非常有利的地位，並且相信我們的儲備金將使我們在執行今天討論的商業和臨床戰略方面處於非常有利的地位。

Your next question comes from the line of Michelle Gilson of Canaccord.

您的下一個問題來自 Canaccord 的 Michelle Gilson。

I'll add my congratulations on the quarter. It's been great to see the acceleration in the launch. Given the acceleration of patient adds that you've seen, I'm looking at my numbers, it looks like a little north of 35% growth in the rate that you're having patients on drug here from the January numbers you provided. Do you expect that trend to really be continuing at the same rate moving into the second quarter? And then what are some of the levers you can pull to get more patients on drug?

我要對本季表示祝賀。很高興看到產品上市速度加快。鑑於您看到的患者新增數量加速成長，我查看了一下數據，從您提供的1月數據來看，您這裡的用藥患者比例似乎增加了35%以上。您預計這一趨勢在第二季會繼續保持相同的成長速度嗎？接下來，您可以採取哪些措施讓更多患者用藥？

Yes. Michelle, we're doing our level best to make sure we continue to increase quarter-on-quarter in the important metrics. We really do want to make sure we get more in increasing new patient start forms quarter-by-quarter. And that's one of the big levers. We want to make sure the conversion rate, I'll come back to that lever in a moment. We want to make sure the conversion rates continues to increase until we get to the large majority. We're already at the majority, 74%, make sure they're converting.

是的。 Michelle，我們正在竭盡全力，確保重要指標逐季持續成長。我們確實希望確保新患者入院申請表逐季增加。這是重要的槓桿之一。我們希望確保轉換率，我稍後會談到這個槓桿。我們希望確保轉換率持續提升，直到達到絕大多數。我們已經達到大多數，74%，確保他們能夠進行轉換。

And we want to continue with especially the stacking effects I alluded to earlier, while we'll never have 100% rate of patients on drug. We want to have that again, be the large majority or the large fraction on paid patients, and it ought to be, and we're going in exactly the right direction. So we're very happy with all those things building in the right direction. The levers really involve access, I think, in 2 ways in education that comes with access.

我們希望繼續保持我之前提到的疊加效應，儘管我們永遠無法達到100%的患者服藥率。我們希望再次實現這一目標，讓絕大多數或大部分患者都付費就醫，這應該如此，而且我們正朝著正確的方向前進。因此，我們很高興看到所有工作都在朝著正確的方向發展。我認為，真正的槓桿在於獲取途徑，在獲取途徑帶來的教育方面，主要體現在兩個方面。

So, for example, yes, I mean, 2 years of COVID has had a big impact on how drugs are talked about. New medicines are marketed and education around those medicines, especially at centers of excellence, not exclusively, but especially. So, we'd love to be able -- there's no substitute for in-person interactions, both with medical science, education, as well as the ability of sales reps to talk about the product in an appropriate way around the label. So we hope that, that will start to open up.

舉個例子，沒錯，兩年的新冠疫情對人們談論藥物的方式產生了很大的影響。新藥的市場推廣和相關教育，尤其是在卓越中心，尤其如此。我們希望能夠——無論是在醫學科學、教育方面，還是銷售代表在標籤周圍以適當的方式談論產品，面對面的互動都是無可取代的。我們希望這方面的發展能夠開始。

In the meantime, though, we've redoubled our efforts to try to meet the physician where they want to be met and how they want to be met. So, we expanded our digital footprint, expanded the ways we can do some of these programs. really taken in suggestions from the medical community about how to make sure they are more aware of TAVNEOS and understand what they need to know. So access in education on the health care practitioner side is one big lever, and we're trying to push and pull that lever as appropriate as we can as we've learned more and more about how to work with a brand new high science product like TAVNEOS in this current environment.

同時，我們加倍努力，力求在醫生希望得到服務的地方，以他們希望的方式得到服務。因此，我們擴大了數位覆蓋範圍，拓展了進行某些專案的方式。我們認真聽取了醫學界關於如何確保他們更加了解TAVNEOS並理解他們需要了解的內容的建議。因此，醫療保健從業人員的教育可近性是一個重要的槓桿，隨著我們越來越了解如何在當前環境下使用像TAVNEOS這樣的全新高科技產品，我們正在盡可能地推動和利用這一槓桿。

The other side is on the patient side. And again, using hopefully, appropriate -- wait, not hopefully, but definitely using appropriate methods, we'd love to be able to help patients have better, more thorough conversations with their health care practitioners about the properties of TAVNEOS, the data and what it might mean for their particular condition. These are really motivated patients in the ANCA world. They haven't always had much to organize around, frankly. So we're hoping that we can help them, again, with appropriate educational access about not just their disease, but the mechanism of action of this drug.

另一方是患者。再次強調，我們希望能夠透過適當的——等等，不是希望，而是絕對適當的方法，幫助患者與他們的醫療保健醫生進行更好、更深入的溝通，了解TAVNEOS的特性、相關數據以及它對他們特定病情的意義。在ANCA領域，這些患者確實積極主動。坦白說，他們一直以來都沒有什麼可以組織起來的。因此，我們希望能夠再次幫助他們，透過適當的教育途徑，不僅幫助他們了解疾病，也幫助他們了解這種藥物的作用機制。

And again, how they might have intelligent conversations with their doctors about what this drug may or may not mean in their particular case. So that's something we're working on very much. And then, I guess, finally, peer-to-peer discussions, especially in and around major conferences to the extent that, again, we can appropriately encourage those or make those forms available to allow peers to talk to each other about their experience of TAVNEOS today, I think that's going to be very powerful because many of those anecdotes are extremely interesting, extremely moving.

還有，他們如何與醫生進行深入的溝通，了解這種藥物對他們的具體情況可能或可能不意味著什麼。所以，這是我們正在努力的方向。最後，我想，同儕之間的討論，尤其是在大型會議期間和會議期間，我們應該適當地鼓勵這種討論，或提供相關表格，讓同儕們能夠互相交流他們今天使用TAVNEOS的經驗。我認為這將非常有力，因為許多軼事都非常有趣，非常感人。

And I'm hoping we'll start hearing a lot more of that at upcoming meetings like European Renal Association, at EULAR and then, of course, a little later on at ERA -- I'm sorry, ACR and ASN here in the United States. But access and education, both on the physician and patient side, I think those are big levers.

我希望我們能在即將舉行的會議上聽到更多這樣的信息，例如歐洲腎臟協會 (European Renal Association)、歐洲腎臟病協會 (EULAR)，當然還有稍後召開的歐洲腎臟病協會 (ERA)——抱歉，是美國的美國腎臟病學會 (ACR) 和美國腎臟病學會 (ASN)。但我認為，無論是醫生還是患者，獲取資訊和接受教育都是重要的槓桿。

Okay. And what are you hearing about, I guess, from your sales organization in terms of, I guess, the key areas of pushback in the areas that you're having to do, I guess, the most work to educate physicians around for starting TAVNEOS, either that, I guess, first to getting that first prescription?

好的。您從銷售部門了解到哪些關鍵方面的阻力？在哪些方面，您需要做最多的工作來教育醫生開始使用 TAVNEOS？或者說，首先要拿到第一張處方？

Yes. That's a really good question. So in general, the good news is that physicians are very quick to pick up the TAVNEOS, what I call, therapeutic value proposition, right? So that's important because they do realize -- and I think the awareness of what we showed in the ADVOCATE trial is fairly high, not perfect yet. There's still a lot of questions around glucocorticoid use and how to start TAVNEOS. And the answer is, if you have a patient that fulfills the description on the label with accuracy of your disease, you start it right away. You don't have to do anything else with bells and whistles around the other -- the background here and use it, that's whatever the background therapy is you deem appropriate for that patient. So that's been a set of questions and those have been very good discussions.

是的。這個問題問得真好。總的來說，好消息是醫生很快就能理解TAVNEOS，也就是我所說的治療價值主張，對吧？這很重要，因為他們確實意識到了──我認為大家對我們在ADVOCATE試驗中所展現的認知度相當高，但還不夠完善。關於糖皮質激素的使用以及如何開始TAVNEOS治療，仍有許多疑問。答案是，如果你的病人符合標籤上的描述，而且病情準確，就可以立即開始使用。你不需要做任何其他花俏的事情——背景知識，然後使用它，無論你認為適合該患者的特定治療方案是什麼。以上就是一系列問題，並且進行了非常有益的討論。

Many discussions early on surrounded accessing the medication. How do I start TAVNEOS, how do I get it? How do I -- how long do I use it? Again, those have been very productive discussions. And more and more, the medical part of that discussion is happening peer-to-peer, which is wonderful. So, I think that those are the kinds of things we were looking at early on.

早期圍繞著藥物獲取展開了許多討論。如何開始使用TAVNEOS？如何獲得？如何使用？要使用多久？這些都是非常有成效的討論。而且，醫療方面的討論越來越多地在同行之間展開，這很棒。所以，我認為這些正是我們早期關注的問題。

We've got a lot of very important and productive input. We've acted on that input and I believe, fundamentally, the path to getting the medication to the appropriate patients has become a lot easier and physicians are understanding more and more that they have a great deal of discretion on how to start TAVNEOS, but the answer is they don't really have to wait if they have a patient that fits the label, they can get TAVNEOS on them right away.

我們收到了很多非常重要且有成效的意見。我們已根據這些意見採取了行動。我相信，從根本上來說，將藥物送到合適的患者手中變得更加容易，醫生們也越來越明白，他們在如何開始TAVNEOS治療方面擁有很大的自主權。但答案是，如果患者符合標籤要求，他們實際上無需等待，就可以立即開始TAVNEOS治療。

Okay. And if I can squeeze one more quick one in here. Can you give us a better sense of, I guess, the percent of patients that are on paid drug that have already been through the 4 weeks of free drug?

好的。如果我可以再快速問一下的話，您能否告訴我們，目前使用付費藥物的患者中，已經享受了4週免費藥物的患者比例是多少？

Well, I'll persuade this, not people -- say, oh, everyone gets a free drug in the first 3 days. That's not true. A lot of people now, especially as things are getting more and more developed, a lot of people go to Rex to pay drug. So, that is not an insignificant fraction, and it's a growing fraction. So that's great. So what we've been also reporting obviously, is the paid drug percentage, right, which as I mentioned, is a little over 60% now that's up markedly from the end of Q4. Now as I mentioned, but it bears repeating, that 60% is a good number at this point in the launch, a very good number.

好吧，我會說服大家，而不是說服別人——比如說，哦，每個人在前三天都能得到一支免費藥物。這不是真的。現在很多人，尤其是在情況越來越發展的情況下，很多人會去Rex付費買藥。所以，這個比例並不小，而且還在成長。這很好。我們一直在報告的顯然是付費藥物的比例，正如我所提到的，現在略高於60%，比第四季末有顯著上升。正如我所提到的，但值得重複的是，60%在目前的發布階段是一個不錯的數字，一個非常好的數字。

Will it ever be 100%? No. And again, it's a snapshot of a moment in time. So even if every single person got to pay drug to be a paid patient at any given moment, you might have referrals that are not yet on paid drug, you will probably always have some quick start people in the equation. But as a proportion of the overall population on our drug, they will become smaller and smaller as a proportion and the proportion of pay will get greater and greater such that the percentage will go from now 60% to some higher number we hope quarter-to-quarter, and in fact, at steady state should be the large majority of people.

它會達到100%嗎？不會。再說一次，這只是一個時間點的快照。所以，即使每個人都需要付費才能成為付費患者，你可能會有一些尚未使用付費藥物的轉診，你很可能總是會有一些快速起步的患者。但是，作為使用我們藥物的總體人群的比例，他們所佔的比例會越來越小，而付費的比例會越來越大，最終這個比例會從現在的60%上升到我們希望的更高數字，逐季度增長，事實上，在穩定狀態下，應該占到絕大多數人的比例。

So what we're finding is, as you can well imagine, even from an inferential evidence to go to 60% paid at this snapshot in time that I'm just reporting from about -- from over 30%, I was misquoted at Q4, but let's just say over 30% at Q4, you can see that clearly that the folks are getting on paid drug faster. Fewer are getting even quick start. They're going direct to pay and overall, the stacking effect of folks that are in the funnel, in the system, if you will, and then getting their prescriptions refilled under paid plans is greater. So all that is to the good.

所以，正如你所想的，我們發現，即使從推論證據來看，我報告的這個時間段內付費率達到60%左右——超過30%（我之前說的第四季度付費率是錯誤的，但我們假設第四季度超過30%），你就能清楚地看到，人們開始付費用藥的速度越來越快。快速開始付費用藥的人越來越少。他們直接付費，總的來說，那些進入付費管道、進入付費系統的人，透過付費計畫續藥的疊加效應更大。所以這一切都是好的。

Your next question comes from the line of Ed White of H.C. Wainwright.

您的下一個問題來自 H.C. Wainwright 的 Ed White。

So I guess most of my questions were answered already. I just have one follow-up on the in-person detailing. You had said it dropped under 40% in January and up to about 60% recently. What was it in the fourth quarter? And do you see that trajectory growing in the second quarter and beyond? And then perhaps another question on the sales force. Do you think the sales force is rightsized now? Or do you think that you need to add more field reps to increase penetration?

所以我想我的大部分問題都已經得到了解答。我只想問一個關於現場銷售的後續問題。您之前說過，1月的銷售額下降了不到40%，最近又上升到了60%左右。那麼第四季的情況如何呢？您認為第二季及以後的銷售成長趨勢會如何嗎？然後，或許還有一個關於銷售團隊的問題。您認為現在的銷售團隊規模合適嗎？或者您認為需要增加更多的現場銷售代表來提高滲透率嗎？

In the fourth quarter, the in-person detailing hovered around 50% and somewhere between 45% and 50%, then it took a dip in January to below 40%, which was pretty dire. And then it's gone back up, as I said, to approximately 60%. We hope it's continuing to grow. It will take time, though, for this health care system to sort out the effects of COVID. I don't think we're going to go from, say, 60% to 80% anytime soon. That's for sure. They're still working through their staff shortages. They're still working through other procedures as a consequence of the COVID hangover, if you will. So that's something to remember. But we are hoping that these increase in-person visits will result in greater efficacy of the ability to educate and get the drug out to people. Now I had your other question in mind, and I've lost it. What was the second part of your question.

第四季度，面對面問診的比例徘徊在50%左右，介於45%到50%之間。然後在一月跌至40%以下，情況相當糟糕。然後，正如我所說，它又回升到了60%左右。我們希望它能繼續成長。不過，醫療系統需要時間來消除新冠疫情的影響。我認為我們不會很快從60%上升到80%。這是肯定的。他們仍在努力解決人員短缺問題。如果你願意這麼說的話，他們仍在處理新冠疫情後遺症帶來的其他程序。所以，這是需要記住的事情。但我們希望這些面對面問診的增加能更有效地進行藥品教育，並將藥物分發給人們。我剛才想起了你的另一個問題，但我記不清了。你問題的第二部分是什麼？

Is the sales force rightsized now...

銷售團隊現在是否適合規模？ …

Thank you. Forgive me. I jotted it down on a piece of paper that I don't bear. Yes, look, we did a lot of work on modeling the field force size prior to launch. I think that research was very, very thorough. We believe at this time, we're probably well within the range of our research. Having said that, we will -- we are looking at it literally week by week. And when we find a need to adapt, if there is such need, we will do so. But right now, I do think we're covering the situation very well. The early returns are very good.

謝謝。請原諒。我把它草草記在了一張我沒帶的紙上。是的，你看，我們在發射前做了很多工作來模擬戰場兵力規模。我認為這項研究非常非常透徹。我們相信，目前我們可能已經完全在研究範圍內了。話雖如此，我們確實會——我們正在每週都進行研究。當我們發現需要調整時，如果有這樣的需求，我們就會這樣做。但目前，我確實認為我們對情況的了解非常充分。早期的回報非常好。

And again, the Q1 numbers speak for themselves with a 5-fold increase in revenue, the ability to treble, if you will, the number of unique prescribers. The fact that our conversion rates are good. The fact that, again, we nearly doubled the patients on drug. So I think we're making good progress. We're tracking in excess of the optimistic parts of our model, if you will, but we will continue to go where the data take us. And if we need to change the size of the field force, we will not hesitate to do so.

第一季的數據不言而喻：營收成長了5倍，獨立處方數量也增加了兩倍。我們的轉換率很高。用藥患者數量幾乎翻了一番。所以我認為我們進展順利。我們追蹤的數據超出了模型中的樂觀部分，但我們將繼續追隨數據的指引。如果我們需要調整現場團隊的規模，我們會毫不猶豫地去做。

There are no further questions at this time. Please continue, Mr. Tom.

目前沒有其他問題。請繼續，湯姆先生。

Well, thank you so much. That was a very stimulating discussion and set of questions. I very much appreciate everyone joining our call today. I very much look forward to talking about our progress at our next quarterly call. You may now disconnect. Thank you and good evening.

好的，非常感謝。這是一場非常精彩的討論，也提出了一系列問題。非常感謝大家今天參加我們的電話會議。我非常期待在下次季度電話會議上討論我們的進展。現在您可以掛斷電話了。謝謝大家，晚上好。

This concludes today's conference call. You may now disconnect. Thank you.

今天的電話會議到此結束。您可以掛斷電話了。謝謝。