Verastem Inc (VSTM) 2019 Q3 法說會逐字稿

Good afternoon, and welcome to the Verastem Oncology third quarter financial results conference call on Tuesday October 29, 2019. (Operator Instructions) Please be advised that this call is being recorded at the company's request and will be available on the company's website for a period of 90 days from today.

下午好，歡迎參加 2019 年 10 月 29 日星期二的 Verastem Oncology 第三季財務業績電話會議。（操作員指示）請注意，本次通話是根據公司的要求進行錄音的，並將從今天起在公司網站上保留 90 天。

At this time, I would like to introduce Mr. John Doyle, Vice President of Investor Relations and Finance at Verastem Oncology. Please go ahead.

現在，我想介紹 Verastem Oncology 投資者關係和財務副總裁 John Doyle 先生。請繼續。

Welcome, everyone, and thank you for joining us this afternoon to discuss Verastem Oncology's financial results and corporate update for the third quarter of 2019. I'm joined today by Brian Stuglik, Chief Executive Officer; Dan Paterson, President and Chief Operating Officer; and Rob Gagnon, Chief Financial and Business Officer.

歡迎大家，感謝您今天下午加入我們，討論 Verastem Oncology 2019 年第三季的財務業績和公司最新動態。今天與我一起參加的是執行長 Brian Stuglik；總裁兼營運長 Dan Paterson；以及首席財務和業務官 Rob Gagnon。

During today's call, Brian will provide some opening comments and provide a corporate update, Dan will discuss a few clinical development highlights and then Rob will provide an overview of our third quarter financial results. Brian will then provide some brief summary remarks before opening the call up for your questions. Earlier today, we issued a press release detailing our third quarter 2019 financial results. The release is available on our website at verastem.com.

在今天的電話會議中，Brian 將提供一些開場評論並提供公司最新情況，Dan 將討論一些臨床開發亮點，然後 Rob 將概述我們的第三季財務表現。然後，Brian 會做一些簡短的總結性發言，然後開始回答大家的問題。今天早些時候，我們發布了一份新聞稿，詳細介紹了我們 2019 年第三季的財務表現。新聞稿可在我們的網站 verastem.com 上查閱。

Before we begin our formal comments, I'll remind you that we will be making forward-looking assertions during today's call that represent the company's intentions, expectations or beliefs concerning future events, which constitute forward-looking statements for the purpose of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements.

在我們開始正式評論之前，我要提醒您，我們將在今天的電話會議上做出前瞻性的斷言，代表公司對未來事件的意圖、期望或信念，這些斷言構成了 1995 年《私人證券訴訟改革法》安全港條款規定的前瞻性陳述。所有前瞻性陳述均受各種因素、風險和不確定因素的影響，例如今天宣布此電話會議的新聞稿中以及我們向美國證券交易委員會提交的文件中詳細說明的因素、風險和不確定因素，這些因素、風險和不確定因素可能會導致實際結果與此類陳述表達或暗示的結果存在重大差異。

In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements. We refer you to the disclosure notice section in our earnings release we issued today and the Risk Factors section of the annual report on Form 10-K for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements.

此外，任何前瞻性陳述僅代表我們截至本紀錄日期的觀點，不應被視為代表我們在任何後續日期的觀點。我們明確否認有更新此類聲明的任何義務。請您參閱我們今天發布的收益報告中的揭露通知部分以及 10-K 表年度報告中的「風險因素」部分，其中討論了可能導致實際結果與這些前瞻性陳述存在重大差異的重要因素。

With that, I would now like to turn the call over to Brian Stuglik. Brian?

說完這些，現在想將電話轉給 Brian Stuglik。布賴恩？

Thank you, John. Good afternoon, everyone, and thank you for joining us on today's call. In 2019, Verastem Oncology has made continued progress in our mission to bring important new medicines to patients battling cancer. Our lead drug, COPIKTRA, known as duvelisib, just completed its fourth full quarter on the market. And net revenues for the 3 months ended September 30, 2019, were $4 million, a 33% increase over the prior quarter. Year-to-date, COPIKTRA has generated revenues of $8.7 million and we remain on track to achieve the $12 million to $14 million that we previously guided for 2019.

謝謝你，約翰。大家下午好，感謝您參加今天的電話會議。2019年，Verastem Oncology 在為癌症患者提供重要新藥的使命上繼續取得進展。我們的主要藥物 COPIKTRA（稱為 duvelisib）剛剛完成其在市場上的第四個完整季度。截至 2019 年 9 月 30 日的三個月淨收入為 400 萬美元，較上一季成長 33%。今年迄今，COPIKTRA 已創造 870 萬美元的收入，我們仍有望實現先前預期的 2019 年 1,200 萬至 1,400 萬美元的收入。

In addition to increasing quarter-over-quarter revenues, the number of prescribing physicians grew by 30% in the third quarter compared to the second quarter of 2019. We continue to see solid progress across all of our commercial efforts, including physician education and contracting. We are making progress in understanding and addressing market dynamics, identifying appropriate patients for treatment and building strong access across the country. Overall, we are highly encouraged by COPIKTRA's positive upward sales trajectory, and we continue to believe in our peak annual sales estimates of $200 million to $300 million for the current indications for which it is approved, including chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma.

除了營收季增外，第三季開處方的醫生數量也比 2019 年第二季增加了 30%。我們所有的商業努力都取得了穩步進展，包括醫生教育和合約。我們在理解和應對市場動態、確定適合治療的患者以及在全國範圍內建立強大的治療管道方面取得了進展。總體而言，COPIKTRA 積極的銷售上升軌跡令我們感到非常鼓舞，我們仍然相信，對於該藥物目前獲批的適應症，包括慢性淋巴細胞白血病、小淋巴細胞淋巴瘤和濾泡性淋巴瘤，我們的峰值年銷售額估計為 2 億至 3 億美元。

That being said, we recognize that the COPIKTRA sales ramp has been slower than expected. As such, we have determined that we need to better align our upcoming expenses with the current launch trajectory. To that end, we announced today that we will be reducing our 2020 operating expenses by approximately $25 million through a series of initiatives, including a workforce reduction and lowering operating expenses. Specifically, we will be eliminating approximately 40 current positions across all functions. These changes are designed to streamline operations, speed execution and optimize the field organization for improved account access and performance. We expect these changes to have minimal impact on top line revenue results.

話雖如此，我們也意識到 COPIKTRA 的銷售成長速度比預期慢。因此，我們確定我們需要更好地將即將發生的支出與當前的發布軌跡結合起來。為此，我們今天宣布，我們將透過一系列舉措，包括裁員和降低營運費用，將 2020 年的營運費用減少約 2,500 萬美元。具體來說，我們將裁減所有職能部門約 40 個現有職位。這些變更旨在簡化操作，加快執行速度並優化現場組織，以改善帳戶存取和效能。我們預期這些變動對營業收入結果的影響將微乎其微。

The workforce reduction component of the initiative was completed this week. This reduction was a difficult decision, but based on our current plans and assumptions, we believe these changes give us the best opportunity to be successful with our stated "6-2-5" corporate plan. In our last earnings call, we communicated our new “6-2-5” plan, which is the commitment to: first, have COPIKTRA revenues on a positive upward trajectory and closing the gap between revenue and commercial spend within the first 6 months, which would be by the end of 2019; second, to achieve cash flow positive breakeven for both the COPIKTRA commercial and clinical programs within the next 2 years or by mid-2021; and third, to broaden the indication for COPIKTRA and have at least one additional marketed product, along with robust pipeline of assets in development within the next 5 years or by mid-2024.

該計劃的裁員部分已於本週完成。這次裁員是一個艱難的決定，但根據我們目前的計劃和假設，我們相信這些變化為我們成功實施「6-2-5」公司計劃提供了最好的機會。在我們上次的財報電話會議上，我們傳達了新的「6-2-5」計劃，即承諾：首先，使 COPIKTRA 收入呈現積極的上升趨勢，並在前 6 個月內縮小收入和商業支出之間的差距，也就是到 2019 年底；第二，未來兩年內或2021年中期，實現COPIKTRA商業和臨床專案的現金流量正向損益平衡；第三，擴大 COPIKTRA 的適應症，在未來 5 年內或到 2024 年中期至少推出額外的上市產品，並開發強大的資產管線。

Based on our current assumptions, these changes will help set us on a positive path that provides us with approximately 18 to 24 months cash runway to deliver on what we believe can be achieved with COPIKTRA. Collectively, the intent of these changes is to focus our spend on areas that will directly benefit COPIKTRA uptake in the market, ensure continuity of our development efforts while condensing certain layers in the organization.

根據我們目前的假設，這些變化將幫助我們走上一條積極的道路，為我們提供大約 18 到 24 個月的現金流來實現我們認為可以透過 COPIKTRA 實現的目標。總的來說，這些變化的目的是將我們的支出集中在直接有利於 COPIKTRA 在市場上普及的領域，確保我們開發工作的連續性，同時壓縮組織中的某些層級。

We recognize that the staff reduction personally impacts many talented employees, and we wish to sincerely thank all those who are affected for their important contributions to the company. Importantly, we remain deeply committed to driving the adoption of COPIKTRA in the U.S. and to expanding this footprint both in other global geographies and in additional hematologic malignancy indications.

我們認識到裁員對許多優秀員工產生了個人影響，我們衷心感謝所有受到影響的員工為公司做出的重要貢獻。重要的是，我們仍然堅定地致力於推動 COPIKTRA 在美國的應用，並在全球其他地區和其他血液系統惡性腫瘤適應症中擴大這一足跡。

With that, I'll turn it over to Dan.

說完這些，我就把麥克風交給丹。

Thank you, Brian. There have been multiple positive developments on the business development, clinical and regulatory fronts. For the BD front, in July, we executed a new strategic ex-U. S. partnership, an exclusive license agreement with Sanofi to develop and commercialize COPIKTRA in Russia and CIS, Turkey, the Middle East and Africa for a total of 78 countries.

謝謝你，布萊恩。業務發展、臨床和監管方面都取得了多項積極進展。對於 BD 方面，7 月份，我們執行了一項新的策略 ex-U。S. 合作夥伴關係，與賽諾菲達成獨家授權協議，在俄羅斯和獨聯體、土耳其、中東和非洲共 78 個國家開發和商業化 COPIKTRA。

Under the terms of this agreement, we received an upfront payment of USD 5 million, and we're eligible to receive aggregate future payments of up to USD 42 million if certain development and sales milestones are successfully achieved. We're also eligible to receive double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories.

根據本協議條款，我們收到了 500 萬美元的預付款，如果成功實現某些開發和銷售里程碑，我們有資格獲得高達 4,200 萬美元的未來付款總額。我們還可以根據 COPIKTRA 在授權地區未來的淨銷售額獲得兩位數百分比的版稅。

On the regulatory front, we're planning to submit a marketing authorization application to the European Medicines Agency, seeking approval for duvelisib in patients with relapsed or refractory CLL/SLL and FL by the end of the year. Duvelisib recently received orphan drug designation from the FDA for use in the treatment of T-cell lymphoma. Duvelisib is not currently approved for the treatment of T-cell lymphoma, however, we're currently conducting the registration-directed Phase II PRIMO study in patients with relapsed/refractory T-cell lymphoma, an aggressive type of lymphoma, to further characterize its efficacy and tolerability in this population.

在監管方面，我們計劃向歐洲藥品管理局提交行銷授權申請，尋求在年底前批准 duvelisib 用於復發或難治性 CLL/SLL 和 FL 患者。Duvelisib 最近獲得 FDA 頒發的孤兒藥物資格，用於治療 T 細胞淋巴瘤。Duvelisib 目前尚未被批准用於治療 T 細胞淋巴瘤，但是，我們目前正在對復發/難治性 T 細胞淋巴瘤（一種侵襲性淋巴瘤）患者進行註冊指導的 II 期 PRIMO 研究，以進一步確定其在該人群中的療效和耐受性。

The dose-optimization, dose-selection portion of the PRIMO study was completed earlier this year, and we submitted the data for presentation at the upcoming American Society of Hematology 2019 annual meeting in December. The registration-directed portion of the PRIMO study is currently ongoing and is to be conducted in the U.S., Europe and Japan.

PRIMO 研究的劑量優化、劑量選擇部分已於今年稍早完成，我們已提交數據以便在即將於 12 月舉行的美國血液學會 2019 年年會上進行展示。PRIMO 研究的註冊指導部分目前正在進行中，將在美國、歐洲和日本進行。

We also made progress recently with our global duvelisib partners. In early October, Yakult Honsha dosed the first patient in a Phase Ib Japanese bridging study, evaluating COPIKTRA in patients with relapsed or refractory CLL/SLL following at least one prior therapy. Their multicenter open-level Phase Ib study is expected to enroll approximately 10 patients, and the primary end point of the study is objective response rate. Secondary end points of the study include overall survival, progression-free survival and safety. This study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology's Phase III DUO study, and if successful, the results of Yakult's bridging study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan.

我們最近與全球合作夥伴也取得了進展。10 月初，養樂多本社在日本 Ib 期橋接研究中對首位患者進行了給藥，該研究評估了 COPIKTRA 對至少接受過一種先前治療的複發或難治性 CLL/SLL 患者的療效。他們的多中心開放程度 Ib 期研究預計將招募約 10 名患者，研究的主要終點是客觀緩解率。研究的次要終點包括總體存活期、無惡化存活期和安全性。這項研究有望作為一項基於 Verastem Oncology 第三階段 DUO 研究中觀察到的療效和安全性的橋接研究，如果成功，Yakult 橋接研究的結果有望成為 COPIKTRA 在日本治療復發或難治性 CLL/SLL 的監管提交基礎。

Also on the global development front, duvelisib is partnered with CSPC Pharmaceutical Group in China. We currently expect CSPC to dose the first patient in their bridging study by the end of 2019. Throughout third quarter and to the early part of the fourth quarter, Verastem and its external collaborators have been actively generating and presenting supportive duvelisib data at medical meetings. A total of 7 duvelisib abstracts were presented at 2 medical oncology meetings, the 18th Annual International Workshop on Chronic Lymphocytic Leukemia and the Society of Hematologic Oncology 2019 Annual Meeting.

此外，在全球發展方面，duvelisib 與中國石藥集團進行了合作。我們目前預計，CSPC 將在 2019 年底前為他們的橋接研究中的第一位患者給藥。在整個第三季到第四季初，Verastem 及其外部合作者一直在醫學會議上積極產生和展示支持性 duvelisib 數據。共有 7 篇 duvelisib 摘要在 2 場醫學腫瘤學會議、第 18 屆慢性淋巴球白血病國際研討會和 2019 年血液腫瘤學會年會上進行了展示。

Collectively, the presented abstracts highlighted a wide range of duvelisib clinical data, including data from the Phase III DUO study in patients with relapsed/refractory CLL/SLL, dose modification data from the Phase III DUO study, data from a post hoc analysis evaluating the effect of COPIKTRA on lymphocytosis, including with patients with high risk factors and data from the Phase II DYNAMO study on patients with refractory marginal zone lymphoma. These presented data continue to support the ongoing development of COPIKTRA.

總的來說，所呈現的摘要重點介紹了廣泛的 duvelisib 臨床數據，包括針對複發/難治性 CLL/SLL 患者的 III 期 DUO 研究的數據、來自 III 期 DUO 研究的劑量調整數據、來自評估 COPIKTRA 對淋巴細胞增多症影響的事後分析的數據（包括具有高風險因素的患者）以及來自淋巴瘤數據的研究區對 II 期患者的研究區組 II 的患者）以及來自淋巴瘤數據 II 期的研究因素 II。這些呈現的數據持續支持 COPIKTRA 的持續發展。

And finally, important preclinical research was presented at the Fifth International Conference on New Concepts in Lymphoid Malignancies. The presented data showed superior anticancer activity of the dual PI3K-delta/gamma inhibitor, duvelisib, compared to the PI3K-delta inhibitor, idelalisib, in preclinical models of mantle cell lymphoma. As we stated previously, our long-term goal is to expand duvelisib development into additional lymphoid malignancy indications, and these preclinical data support the future study of duvelisib through clinical trials in patients with MCL.

最後，第五屆淋巴系統惡性腫瘤新概念國際會議上展示了重要的臨床前研究。所呈現的數據顯示，在套細胞淋巴瘤的臨床前模型中，雙重 PI3K-delta/gamma 抑制劑 duvelisib 具有比 PI3K-delta 抑制劑 idelalisib 更優的抗癌活性。正如我們之前所說，我們的長期目標是將 duvelisib 開發擴展到其他淋巴系統惡性腫瘤適應症，這些臨床前數據支持未來透過 MCL 患者的臨床試驗對 duvelisib 進行研究。

In addition to these ongoing studies, we are also working towards initiation of 3 company-sponsored studies. One is randomized Phase II open-label intermittent dosing study, which will be named TEMPO and will evaluate the effect of planned 2-week dosing holidays on tumor response and safety in patients with relapsed/refractory indolent non-Hodgkin lymphoma who've received at least 1 prior systemic therapy. The purpose of this study is to build on the data previously presented at medical meetings that show that dose interruptions are an effective means of managing side effects and keeping patients on therapy without impacting efficacy. We recently received IRB approval for this multicenter study, which is expected during to enroll approximately 100 patients and will commence by the end of this year.

除了這些正在進行的研究之外，我們還致力於啟動 3 項由公司贊助的研究。其中一項是隨機 II 期開放標籤間歇性給藥研究，將被命名為 TEMPO，並將評估計劃的兩週給藥假期對已接受過至少 1 次全身治療的複發/難治性惰性非霍奇金淋巴瘤患者的腫瘤反應和安全性的影響。這項研究的目的是基於先前醫學會議上提出的數據，這些數據表明劑量中斷是控制副作用和讓患者繼續治療而不影響療效的有效手段。我們最近獲得了 IRB 對這項多中心研究的批准，預計將招募約 100 名患者，並將於今年年底開始。

The second study is a Phase Ib2 study, which will combine duvelisib with the PD-1 inhibitor, pembrolizumab, in patients with head and neck squamous cell carcinoma. The immunomodulatory effect of duvelisib's dual PI3K inhibition that was previously seen in preclinical research provides the rationale for this combination. We look forward to further exploring the effects of this combination in the clinic and we expect this study to commence by the end of this year.

第二項研究為 Ib2 期研究，研究將 duvelisib 與 PD-1 抑制劑 pembrolizumab 合併用於治療頭頸部鱗狀細胞癌患者。duvelisib 的雙重 PI3K 抑制的免疫調節作用在先前的臨床前研究中被發現，這為此組合提供了理論基礎。我們期待進一步探索這種組合在臨床上的效果，並預計這項研究將在今年年底開始。

And third, we're in final preparation phase for the confirmatory Phase III DUO study aimed at converting the accelerated approval of COPIKTRA in FL into full approval. We're working with the FDA on final details and we expect to commence this study by the end of the year.

第三，我們正處於確認性 III 期 DUO 研究的最後準備階段，該研究旨在將 COPIKTRA 在 FL 的加速批准轉化為全面批准。我們正在與 FDA 合作確定最終細節，預計將在今年年底開始這項研究。

Now I'd like to turn the call over to Rob for the financials.

現在我想把電話轉給 Rob，討論財務問題。

Thank you, Dan. Since we issued a press release earlier today, outlining our third quarter financial results, I'll just review the highlights. And to supplement our GAAP financial results, we have prepared and presented non-GAAP financial measures to help provide additional transparency and period-over-period comparability with respect to the company's operating performance.

謝謝你，丹。由於我們今天早些時候發布了一份新聞稿，概述了我們的第三季財務業績，因此我只會回顧一下重點內容。為了補充我們的 GAAP 財務結果，我們編制並呈現了非 GAAP 財務指標，以協助提高公司經營績效的透明度和同期可比性。

We use these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. A reconciliation between the non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying the press release. The reconciling items include executive severance and separation costs as well as significant noncash charges and expenditures reflected in the income statement related to the stock-based compensation, noncash interest expense and amortization of acquired intangibles.

我們使用這些指標以及其他因素來評估和分析營運結果和趨勢並做出財務和營運決策。新聞稿附帶的表格中包含了非公認會計準則財務指標與最具可比性的公認會計準則財務指標之間的對帳表。調節項目包括高階主管遣散費和離職費用以及損益表中反映的與股票薪酬、非現金利息費用和收購無形資產攤銷相關的重大非現金費用和支出。

I'll now start with revenue. Total revenue for the 3 months ended September 30, 2019, or the 2019 quarter was $9 million. Net product revenue for the 2019 quarter was $4 million. That compares to $0.5 million for the 3 months ended September 30, 2018, or the 2018 quarter, following the FDA's approval of COPIKTRA on September 24, 2018.

我現在先談收入。截至 2019 年 9 月 30 日的三個月或 2019 年季度的總收入為 900 萬美元。2019 年季度淨產品收入為 400 萬美元。相較之下，自 2018 年 9 月 24 日 FDA 批准 COPIKTRA 以來，截至 2018 年 9 月 30 日的三個月或 2018 年季度的收入為 50 萬美元。

License and collaboration revenue for the 2019 quarter was $5 million compared to $15 million for the 2018 quarter. The 2018 quarter included license revenue of $15 million related to an upfront payment pursuant to license and collaboration agreement executed between Verastem and CSPC in September 2018, partially offset by a $5 million upfront payment received pursuant to a license and collaboration agreement executed between Verastem and Sanofi in July 2019.

2019 年季度的授權和合作收入為 500 萬美元，而 2018 年季度為 1500 萬美元。2018 年季度的許可收入包括 1500 萬美元，與根據 Verastem 和 CSPC 於 2018 年 9 月簽署的許可和合作協議支付的預付款有關，部分被根據 Verastem 和 Sanofi 於 2019 年 7 月簽署的許可和合作協議收到的 500 萬美元預付款所抵消。

Total operating expenses for the 2019 quarter were $35.1 million compared to $41.4 million for the second quarter of 2019 and compare to $37.1 million for the 2018 quarter.

2019 年季度總營運費用為 3,510 萬美元，而 2019 年第二季為 4,140 萬美元，2018 年季度為 3,710 萬美元。

Non-GAAP operating expenses for the 2019 quarter were $32.8 million compared to $36.2 million for the second quarter of 2019 and compare to $35 million for the 2018 quarter.

2019 年季度非 GAAP 營業費用為 3,280 萬美元，而 2019 年第二季為 3,620 萬美元，2018 年季度為 3,500 萬美元。

Research and development expense for the 2019 quarter was $12.2 million compared to $11.6 million for the 2018 quarter. The increase of $0.6 million or 5.2% was primarily related to the timing of CRO cost. Selling, general and administrative expense for the 2019 quarter was $22.2 million compared to $25.4 million for the 2018 quarter. The decrease of $3.2 million or 12.6% was primarily due to a decrease of $2.3 million in consulting and professional fees primarily related to the support of launch activities in the 2018 quarter and a decrease of $0.9 million in personnel-related costs, including noncash stock-based compensation.

2019 年季度研發費用為 1,220 萬美元，而 2018 年季度為 1,160 萬美元。60 萬美元或 5.2% 的增幅主要與 CRO 成本的時間有關。2019 年季度的銷售、一般和行政費用為 2,220 萬美元，而 2018 年季度為 2,540 萬美元。減少 320 萬美元或 12.6%，主要由於與 2018 年季度支持發布活動有關的諮詢和專業費用減少 230 萬美元，以及包括非現金股票薪酬在內的人員相關成本減少 90 萬美元。

Interest expense for the third quarter of 2019 was $5 million, which is mainly comprised of interest related to the convertible notes.

2019 年第三季的利息支出為 500 萬美元，主要包括與可轉換票據相關的利息。

Net loss for the 2019 quarter was $30.1 million or $0.41 per share compared to $21.7 million or $0.29 per share for the 2018 quarter, and $42.2 million or $0.57 per share for the second quarter of 2019. Non-GAAP adjusted net loss for the 2019 quarter was $26.2 million or $0.35 per share compared to non-GAAP adjusted net loss of $19.4 million or $0.26 per share for the 2018 quarter, and $35.7 million or $0.48 per share for the second quarter of 2019.

2019 年季度淨虧損為 3,010 萬美元或每股 0.41 美元，而 2018 年季度淨虧損為 2,170 萬美元或每股 0.29 美元，2019 年第二季淨虧損為 4,220 萬美元或每股 0.57 美元。2019 年季度非 GAAP 調整後淨虧損為 2,620 萬美元或每股 0.35 美元，而 2018 年季度非 GAAP 調整後淨虧損為 1940 萬美元或每股 0.26 美元，2019 年第二季非 GAAP 調整後淨虧損為 3570 萬美元或每股 38.48 美元。

And as of September 30, 2019, Verastem had cash and investments of $160.2 million compared to $249.7 million of cash and investments as of December 31, 2018. As Brian mentioned earlier, we are reiterating our 2019 net revenue guidance as we continue to expect COPIKTRA sales to come in at between $12 million and $14 million. This estimate is based on net product revenue to date, current run rates and near-term expectations.

截至 2019 年 9 月 30 日，Verastem 的現金和投資為 1.602 億美元，而截至 2018 年 12 月 31 日的現金和投資為 2.497 億美元。正如 Brian 先前提到的，我們重申 2019 年淨收入指引，因為我們繼續預期 COPIKTRA 的銷售額將達到 1,200 萬美元至 1,400 萬美元之間。該估計值基於迄今為止的淨產品收入、當前運行率和近期預期。

Based on our current operating plans and assumptions, we expect our operating expenses for the full year of 2020 to be in the range of $110 million to $115 million. Looking ahead, we anticipate providing preliminary 2020 net product revenue guidance during our year-end 2019 earnings call.

根據我們目前的營運計劃和假設，我們預計 2020 年全年營運費用將在 1.1 億美元至 1.15 億美元之間。展望未來，我們預計將在 2019 年年終收益電話會議上提供 2020 年淨產品收入的初步指引。

With that, I'll now turn the call back to Brian for closing remarks.

說完這些，我現在將電話轉回給布萊恩，請他作結束語。

Thanks, Rob. I will now review our key upcoming goals and priorities for the months and quarters ahead. Our key priorities are as follows: one, executing on the "6-2-5" plan; two, continuing to execute on the commercial launch of COPIKTRA; three, pursuing regulatory approval in Europe where we expect to submit our MAA by the end of 2019; four, initiating the TEMPO study by the end of 2019; five, initiating the confirmatory Phase III DUETTO study evaluating duvelisib for the treatment of patients with relapsed or refractory follicular lymphoma, that confirmatory study is also expected to start by the end of 2019; six, conducting the registration-directed portion of the Phase II PRIMO study in patients with relapsed or refractory PTCL, for which the dose-optimization, dose-selection portion is now complete and the data have been submitted to ASH 2019 for presentation in December; and seven, initiating the Phase Ib2 combination study, investigating duvelisib and the PD-1 inhibitor, pembrolizumab, in patients with head and neck squamous cell carcinoma by the end of 2019.

謝謝，羅布。我現在將回顧未來幾個月和幾個季度我們的主要目標和優先事項。我們的重點任務是：一是落實「625」計畫；二、繼續執行COPIKTRA的商業發布；三、尋求歐洲監管部門的批准，我們預計在 2019 年底前提交 MAA；四、2019年底啟動TEMPO研究；五、啟動驗證性III期DUETTO研究，評估duvelisib治療復發或難治性濾泡性淋巴瘤患者的效果，此驗證性研究預計也將於2019年底啟動；六、對復發或難治性 PTCL 患者進行 II 期 PRIMO 研究的註冊指導部分，該研究的劑量優化、劑量選擇部分現已完成，數據已提交給 ASH 2019 將於 12 月進行展示；七是啟動 Ib2 期聯合用藥研究，研究 duvelisib 與 PD-1 抑制劑 pembrolizumab 在頭頸部鱗狀細胞癌患者的療效，預計 2019 年底完成。

In closing, I would just like to reiterate that we remain deeply committed to bringing COPIKTRA to patients with these devastating hematologic malignancies. With the announcements made today, we believe that the 18- to 24-month runway will allow us to continue to progress COPIKTRA in its current indications and ensure continuity of our development efforts. We believe we have the right people and right plan in place to maximize the value for both COPIKTRA and Verastem Oncology and for all stakeholders. We look forward to keeping you updated on our progress in the months and quarters ahead.

最後，我只想重申，我們仍然堅定地致力於為患有這些毀滅性的血液系統惡性腫瘤的患者提供 COPIKTRA。透過今天的公告，我們相信 18 到 24 個月的運行時間將使我們能夠繼續推進 COPIKTRA 目前的適應症並確保我們開發工作的連續性。我們相信，我們擁有合適的人才和正確的計劃，可以最大限度地為 COPIKTRA 和 Verastem Oncology 以及所有利害關係人創造價值。我們期待在未來幾個月和幾季向您通報我們的進展。

With that, we'll now open the call up for your questions. Operator?

現在，我們將開始回答大家的提問。操作員？

(Operator Instructions) Our first question comes from Alethia Young with Cantor Fitzgerald.

（操作員指示）我們的第一個問題來自 Cantor Fitzgerald 的 Alethia Young。

This is Emma on for Alethia. So with your plans to streamline and reduce OpEx, how many of the 40 positions that you eliminated were sales reps? And can you give us a sense of what percentage of overall sales force that represent?

這是 Emma 為 Alethia 表演的。那麼，根據您精簡和降低營運支出的計劃，您裁掉的 40 個職位中有多少是銷售代表？您能否告訴我們這佔總銷售人員的比例是多少？

Yes. Thank you for the question. This is Rob. So of the 40 heads, approximately 14 or so fell within the sales organization. And if you recall, when we started the launch, we had about 50 sales reps in the field. So that's the numbers there as far as restructuring on the commercial sales force.

是的。感謝您的提問。這是羅布。因此，在 40 位負責人中，約有 14 位屬於銷售組織。如果你還記得的話，當我們開始發布產品時，我們大約有 50 位銷售代表。這就是商業銷售團隊重組的數字。

Yes. And Emma, I would just add to Rob's comments that when we look at our deployment plan now, we actually are going to cover those offices. Our focus will be mostly now on the high-volume offices. And this move also allows us to put some of our very best sales representatives on newer accounts.

是的。艾瑪，我只想補充羅布的評論，當我們現在查看部署計劃時，我們實際上將覆蓋這些辦公室。我們現在主要關注的是業務量大的辦公室。此舉也使我們能夠將一些最優秀的銷售代表派往新客戶。

Our next question comes from Robert Hazlett with BTIG.

下一個問題來自 BTIG 的 Robert Hazlett。

This is Jake on the line for Bert. I was just wondering maybe could you talk a little bit about your strategy for Europe in light of this current restructuring? And then maybe could you comment on I guess where you are with enrollment in PRIMO? And when we may see data there?

我是傑克，找伯特。我只是想知道，您能否根據當前的重組談談您對歐洲的策略？然後您能否評論一下您在 PRIMO 的註冊情況？什麼時候我們才能在那裡看到數據？

Yes. So this is Dan. I'll say, we've not given guidance on how long PRIMO will take to be done and will say we are ahead of our internal projections and continue to be optimistic. I think once we have a little more of a track record on the expansion phase, we'll give guidance on that.

是的。這就是丹。我想說的是，我們還沒有給出關於 PRIMO 需要多長時間完成的指導，但我會說我們的進展領先於我們的內部預測，並且繼續保持樂觀。我認為，一旦我們在擴張階段有了更多的記錄，我們就會對此提供指導。

And then I guess just on Europe. Just your thoughts on taking it yourself or potentially looking a partner in that geography?

然後我猜只是在歐洲。您是想自己做還是在該地區尋找合作夥伴？

Yes. So we are doing the filing ourselves. We've not made a final decision. We're in discussions with potential partners. We obviously, understand what it would take if we did it ourselves and we'll make the decision probably sometime after filing.

是的。因此我們自己進行歸檔。我們尚未做出最終決定。我們正在與潛在合作夥伴進行討論。我們顯然明白，如果我們自己做的話需要做什麼，並且我們可能會在提交申請後的某個時候做出決定。

And our next question comes from Swayampakula Ramakanth with H.C. Wainwright.

下一個問題來自 H.C. 的 Swayampakula Ramakanth。溫賴特。

Congratulations on the progress. I'm just trying to understand your guidance versus your commentary. You seem to be comfortable with the increase in the prescribers and also your general overall positive commentary on your current sales. But if I look at your guidance, it basically is quite similar to the $4 million that you recognized in this quarter. So I'm just trying to understand how I would triangulate your commentary versus your guidance versus what we should expect in the fourth quarter in terms of sales on COPIKTRA?

祝賀你取得進展。我只是想理解你的指導與評論。您似乎對處方數量的增加感到滿意，並且對當前銷售情況總體給予了積極評價。但如果我看一下您的指引，它基本上與您本季確認的 400 萬美元非常相似。所以，我只是想了解如何將您的評論與您的指導方針以及我們對第四季度 COPIKTRA 銷售的預期進行三角測量？

RK, this is Rob. Thank you for the question. Yes. Just to go back, as we stated, we're committed to delivering on the $12 million to $14 million that we last communicated back in Q2. It's still -- I know it's been over a year, it's still quite early in the overall launch in determining the trajectory. And this is going to be really our first fourth quarter and year-end post launch. I know the product launched very late in September, but it was early months last year. So there is a little bit unknown in terms of seasonality and how December will affect the numbers. So at this point, we felt like the right thing to do is just reiterate the guidance and stay the course because it is just still a little bit early in determining the fourth quarter impact.

RK，這是 Rob。感謝您的提問。是的。回顧一下，正如我們所說的，我們致力於實現我們在第二季度上次溝通的 1200 萬至 1400 萬美元的目標。我知道已經過去一年多了，但從整體發布來看，確定軌跡還為時過早。這實際上將是我們推出新產品後的第一個第四季和年終。我知道該產品是在九月底推出的，但去年九月就推出了。因此，就季節性以及 12 月將如何影響數字而言，還存在一些未知數。因此，在這一點上，我們覺得正確的做法是重申指導並堅持下去，因為確定第四季度的影響還為時過早。

Okay. And then another question on the sales. And also what you think is the total value of this drug in terms of sales? If you -- if we annualize where you are right now, we're looking at like $16 million a year. But your -- you still feel your peak sales could be somewhere between $200 million and $300 million. So what's the difference? What's missing? Obviously, you've spent a solid year in trying to get this drug launched effectively. But how should I think about going from here to $200 million or $250 million? And what are the things that one should expect to see if we need to get there?

好的。然後還有一個關於銷售的問題。您認為這種藥物的銷售額總值是多少？如果我們以現在的情況來計算年化收入，那麼我們每年的收入約為 1600 萬美元。但您仍然覺得您的峰值銷售額可能在 2 億至 3 億美元之間。那麼有什麼差別呢？缺了什麼？顯然，您花了整整一年的時間來嘗試有效地推出這種藥物。但我該如何考慮從現在開始賺到 2 億或 2.5 億美元呢？如果我們要到達那裡，我們應該期待看到什麼呢？

Yes. Thanks again for that follow-up, RK. It's Rob. I'll start and then Brian and Dan may want to add. But keep in mind, in the second quarter, sales grew at a pretty good pace, it was about 80% and in the third quarter, we continued to experience a good high growth rate quarter-over-quarter. It's difficult to predict in the short-term on a quarter-by-quarter basis just where that trend will go. But we're confident that we will continue to experience a pretty good growth rate in the fourth quarter and into next year. And when we talk about the peak sales of $200 million to $300 million, that was really in reference to year 4 or 5 post launch. And so we're making progress against that and we still have ways to go, but that's how we are thinking about peak sales that would come in probably after the fourth year, maybe the fifth year of launch.

是的。再次感謝 RK 的跟進。是羅布。我先開始，然後 Brian 和 Dan 可能想補充。但請記住，第二季度的銷售額成長速度相當不錯，約為 80％，而第三季度，我們繼續保持較高的環比成長率。很難在短期內逐季度預測這一趨勢將會如何發展。但我們確信，第四季以及明年我們將繼續保持相當好的成長率。當我們談論 2 億到 3 億美元的峰值銷售額時，這實際上是指推出後的第 4 年或第 5 年。因此，我們正在朝著這個方向取得進展，但我們還有很長的路要走，但我們認為銷售高峰可能出現在推出後的第四年或第五年。

Yes. And then RK, to build on Rob's commentary, we believe there's about 20,000 or so third-line FL and CLL patients. And when we launched a year ago, we didn't necessarily have all the infrastructure, processes, relationships and people in place. And so over the past year, we've been doing -- improving each of those, starting first with improving thought leaders support and experience. We didn't go through this quarter, but we do have a number of investigator-sponsored studies where we're beginning to see that strong thought leader support. Second, with many of our big accounts, we're trying to secure COPIKTRA as the PI3 of choice through the EMR systems and getting that top spot in those EMR systems. And then third, we're continuing to move to this account-based selling, which will get us focused in the much larger accounts.

是的。然後 RK，基於 Rob 的評論，我們認為大約有 20,000 名左右的三線 FL 和 CLL 患者。當我們一年前推出時，我們不一定具備所有的基礎設施、流程、關係和人員。因此，在過去的一年裡，我們一直在努力改進每一個方面，首先從改善思想領袖的支持和經驗開始。我們沒有經歷過這個季度，但我們確實有一些研究者贊助的研究，我們開始看到強有力的思想領袖支持。其次，對於我們的許多大客戶，我們正嘗試透過 EMR 系統確保 COPIKTRA 作為首選 PI3，並在這些 EMR 系統中佔據首位。第三，我們將繼續轉向基於帳戶的銷售，這將使我們專注於更大的帳戶。

So sorry to just keep questioning on the sales. But just one last question from me. I'm just -- again, I'm trying to figure out if you are removing 30% of your sales force from the 50 you started off. But at the same time, you are hoping for growth in the coming years. So can you just give us a little bit more color as to, yes, it's a good thing, but it won't impact top line, I'm just trying to understand how that works?

非常抱歉，我繼續詢問銷售情況。我只想問最後一個問題。我只是 — — 我再說一遍，我想知道您是否要從最初的 50 名銷售人員中裁掉 30%。但同時，您也希望未來幾年能實現成長。那麼您能否向我們詳細介紹一下，是的，這是一件好事，但它不會影響營收，我只是想了解它是如何運作的？

This is Dan. I think as Brian mentioned, one of the things we've started within the last quarter to focus a lot more on is really the large practices and the large accounts. And I wouldn't reason exactly from the numbers of 50 to 36 on the sales force because we've changed some roles and we have people that were in, say market access roles, before that are now focusing on these big accounts. And so we're putting much more attention on them. One of the things, frankly, that we found is the company that was new to this market, and didn't have the existing relationships with the big practices is there's somewhat of an inverse relationship between access and practice size.

這是丹。我認為正如布萊恩所提到的那樣，我們在上個季度開始更加關注的事情之一就是大型業務和大帳戶。我無法根據銷售人員從 50 人減至 36 人這一數字來做出準確推斷，因為我們已經改變了一些崗位，之前我們的一些員工擔任市場准入的職務，現在則專注於這些大客戶。因此我們對它們給予了更多的關注。坦白說，我們發現，對於剛進入這個市場並且尚未與大型機構建立關係的公司來說，訪問量和機構規模之間存在某種反比關係。

And we can get into the smaller practices where they might see 1 to 4 patients a year and didn't have nearly enough access into the bigger practices. And that's been the renewed focus. And I think that would give us confidence that the opportunity is still there. If you think of how these prescriptions grow, you get a first prescription, the doctor has a good experience and gets the next patient, it's hard for that to catch a lot of tailwinds when the doctor sees 1 to 4 of those kinds of patients a year. You need to get into the places that have the critical mass and we've really doubled down on efforts around that within the last quarter or so.

我們可以進入規模較小的診所，這些診所每年可能只接診 1 至 4 名患者，而規模較大的診所則幾乎沒有足夠的接診機會。這已成為新的焦點。我認為，這會讓我們相信，機會仍然存在。如果您想想這些處方是如何增長的，您會得到第一個處方，醫生會有良好的經驗並得到下一個患者，當醫生每年看到 1 到 4 個這樣的患者時，很難獲得很多順風。你需要進入具有臨界質量的地方，我們在過去一個季度左右確實加倍努力。

Yes. The last thing to build on Dan's answer is, it's also in today's commercial world, a multichannel approach. So we're upping our digital efforts. We are expanding our programs through the group purchasing organizations. And what we didn't necessarily talk about yet is we're also adding a nurse educator role to expand education within the doctor's office. So when you look at all those efforts and we take a step back on the total impact of share of voice in the marketplace, we don't believe this is going to be a significant impact on those efforts.

是的。基於丹的回答的最後一點是，在當今的商業世界中，多通路方式也是一種趨勢。因此，我們正在加大數位化力度。我們正在透過集團採購組織擴大我們的計劃。而且我們還沒有談到的是，我們還將增加護理教育者的角色，以擴大醫生辦公室內的教育。因此，當你審視所有這些努力並回顧市場聲音份額的整體影響時，我們不認為這將會對這些努力產生重大影響。

And next question comes from Matthew Cross with JonesTrading.

下一個問題來自 JonesTrading 的 Matthew Cross。

Congrats on the earning speed. Following up on what I think RK was getting at a bit, but getting maybe specific about the 6-month portion of the "6-2-5" plan is I think that offers some read through to success on your 2- and 5-year goals. I was hoping to get a little bit of clarity around what amount of revenue to expense differential you consider a success in that time frame? I know you've announced you will be cutting $25 million in expenses, which will certainly help bring down burn close to the top line revenue, but since that's a 2020-initiative, and you've reiterated sales guidance of $12 million to $14 million for this year, burning about $30 million a quarter, $120 million on annualized basis. It seems like a rather large gap to close. I'm just trying to understand what more immediate cost savings or sales inflections you're expecting over the next 2 months to meet that 6-month goal? You brought down SG&A pretty substantially, quarter-over-quarter. And so should we expect that to continue or what specifics help get you there?

恭喜賺錢速度。我認為 RK 已經取得了一些進展，但具體了解「6-2-5」計畫的 6 個月部分，我認為這對成功實現您的 2 年和 5 年目標提供了一些幫助。我希望能更清楚地了解，您認為在那個時間範圍內，收入與支出的差額達到多少才算是成功？我知道您已經宣布將削減 2500 萬美元的開支，這肯定有助於降低接近營業收入的支出，但由於這是 2020 年的計劃，而且您重申了今年 1200 萬至 1400 萬美元的銷售預期，每季度支出約 3000 萬美元，按年率計算為 1.2 億美元。這似乎是一個需要彌合的相當大的差距。我只是想了解，為實現 6 個月的目標，您預計未來 2 個月內會有哪些更直接的成本節約或銷售變化？與上一季相比，你們大幅降低了銷售、一般及行政開支。那麼我們是否應該期待這種情況持續下去，或者哪些具體細節可以幫助您實現這一目標？

Yes. Matt, thanks for the question. This is Rob. I'll start. So I just want to make sure it's clear, the goal was within 6 months to have sales on a trajectory that would allow the company to achieve cash flow breakeven for the COPIKTRA franchise within 2 years. So we stated that goal back in the June quarter, so that would put it in June of 2021. We haven't communicated exactly what we would consider to be exact success on that glide path, but as we continue to grow a good double-digit growth rate quarter-over-quarter, we're making progress against that goal.

是的。馬特，謝謝你的提問。這是羅布。我先開始。所以我只是想確保這一點明確，目標是在 6 個月內使銷售量達到預期軌跡，從而使公司在 2 年內實現 COPIKTRA 特許經營的現金流收支平衡。因此，我們在 6 月季度就提出了這個目標，也就是 2021 年 6 月。我們還沒有明確說明我們認為在這條下滑路徑上取得的具體成功，但隨著我們繼續保持逐季度兩位數的良好成長率，我們正在朝著這一目標前進。

And as you can see as we've announced today, we're taking action to significantly reduce the operating expenses and streamline the organization to bring those 2 numbers closer. We haven't given quarterly guidance around operating expenses, but as you've seen in previous quarters, the expenses tend to be somewhat straight line. There's a little bit of lumpiness over the summer months. But for the most part, if you take that guidance of $110 million to $115 million, it would be a pretty good straight-line type allocation if you wanted to estimate that impact or that estimate on a quarterly basis.

正如您所看到的，正如我們今天宣布的那樣，我們正在採取行動大幅削減營運費用並精簡組織結構，以使這兩個數字更接近。我們沒有提供有關營運費用的季度指導，但正如您在前幾個季度看到的那樣，費用往往呈直線增長。夏季會出現一些不平整的情況。但在大多數情況下，如果您採用 1.1 億美元至 1.15 億美元的指導價，如果您想按季度估算該影響或估計值，這將是一個相當不錯的直線型分配。

Great. Okay. No, that's very helpful. I appreciate that, Rob. And just to clarify, is it fair to assume that since the -- some of these head count reduction just occurred, you said, in the last week. Is that something that we would see reflected in the next quarter? Or is that kind of part of the reduction we saw this quarter?

偉大的。好的。不，這非常有幫助。我很感激，羅布。需要澄清的是，是否可以公平地假設，自從您說上週剛開始裁減一些員工。我們會在下個季度看到這項變化嗎？或者這是我們本季看到的減少的一部分？

So a lot of those actions took place this week. And so you should expect to see the benefit of those changes for 2 of the 3 months within the quarter and the full year effect of those changes next year.

本週發生了很多這樣的行動。因此，您應該能夠在本季度的 3 個月中的 2 個月中看到這些變化帶來的好處，並在明年看到這些變化帶來的全年影響。

Perfect. Appreciate that housekeeping. And then just wanted to touch on the DUETTO study that you have announced -- planning to begin by the end of this year. Is there some sort of -- rather tight time frame here? I mean something you guys are going to have quite a lot beginning by the end of the year. Is there anything you can say about the design for that trial? Should we expect this to be a pretty standard combination dose-escalation design? Is there any insight into what the combination-dosing schedule might look like extrapolating from what you saw preclinically? And anything you're looking to avoid or that this particular area of interest in terms of toxicities that might emerge there?

完美的。感謝你的家務管理。然後我想談談您宣布的 DUETTO 研究——計劃於今年年底開始。這裡是否存在某種相當迫切的時間框架？我的意思是，到今年年底，你們就會擁有很多東西。關於該試驗的設計您能說一下嗎？我們是否應該預期這是一個非常標準的組合劑量遞增設計？根據您在臨床前觀察到的情況，是否可以推斷出聯合給藥方案可能是什麼樣的？您希望避免什麼，或就可能的毒性而言，您特別關注的領域是什麼？

Yes. We've not really commented on the design of the study. We're finalizing things with the FDA. I think right around the time we start, we would be disclosing the design.

是的。我們實際上尚未對這項研究的設計發表任何評論。我們正在與 FDA 敲定最終事宜。我認為，我們一開始就會公開設計方案。

And at this time, I'd like to turn the call back to CEO, Brian Stuglik, for any closing remarks.

現在，我想將電話轉回給執行長 Brian Stuglik，請他做最後發言。

Thank you very much. With that, I would like to thank everyone again for dialing in to today's call. Have a great day.

非常感謝。最後，我想再次感謝大家參加今天的電話會議。祝你有美好的一天。

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。