Theratechnologies Inc (THTX) 2021 Q2 法說會逐字稿

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to this Theratechnologies Conference Call. (Operator Instructions) I would like to remind everyone that this conference call is being recorded today, July 15 at 8:30 a.m. Eastern Time.

早上好，女士們，先生們，感謝你們的支持。歡迎參加本次 Theratechnologies 電話會議。（操作員說明）我想提醒大家，今天（7 月 15 日）上午 8:30 正在錄製此電話會議。東部時間。

And I would now like to turn the conference over to Denis Boucher, Vice President, Communications and Corporate Affairs. Mr. Boucher, please go ahead.

現在，我想將會議轉交給傳播和公司事務副總裁 Denis Boucher。布歇先生，請繼續。

Thank you very much. Mr. Paul Lévesque, President and Chief Executive Officer of Theratechnologies; and Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. A Q&A period will follow their presentation.

非常感謝。Theratechnologies 總裁兼首席執行官 Paul Lévesque 先生；高級副總裁兼首席財務官 Philippe Dubuc 先生將在今天的電話會議上發言。問答環節將在他們的演講之後進行。

Before Paul begins his remarks, I've been asked by Theratechnologies to read the following message regarding the forward-looking statements. I would like to remind everyone that Theratechnologies' remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or other future events or developments.

在 Paul 開始他的發言之前，Theratechnologies 要求我閱讀以下有關前瞻性陳述的消息。我想提醒大家，Theratechnologies 今天的言論包含有關其當前和未來計劃、預期和意圖、結果、活動水平、績效、目標或成就或其他未來事件或發展的前瞻性陳述。

In preparing these forward-looking statements, several assumptions were made by Theratechnologies, and there are risks that results actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them.

在準備這些前瞻性陳述時，Theratechnologies 做出了多項假設，並且存在公司實際獲得的結果與這些陳述存在重大差異的風險。因此，公司不能保證任何前瞻性陳述都會實現，請注意不要過分依賴它們。

Theratechnologies refers current and potential investors to the forward-looking information sections of its management's discussion and analysis issued this morning available at www.sedar.com and on EDGAR at www.sec.gov.

Theratechnologies 向當前和潛在投資者推薦其管理層今天上午發布的討論和分析的前瞻性信息部分，這些信息可在 www.sedar.com 和 EDGAR 的 www.sec.gov 上獲取。

Forward-looking statements represent Theratechnologies' expectations as of July 15, 2021. Except as may be required by securities laws, Theratechnologies does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

前瞻性陳述代表 Theratechnologies 截至 2021 年 7 月 15 日的預期。除非證券法可能要求，否則 Theratechnologies 不承擔更新任何前瞻性陳述的任何義務，無論是由於新信息、未來事件或其他原因。

I would now like to turn the conference over to Paul.

我現在想將會議轉交給 Paul。

Thank you, Denis. Good morning, everyone, and thank you for being with us today. Much has happened at Theratechnologies over the last 6 months as we continue to integrate step-wise changes that are intended to best optimize our business and position the company for long-term growth. An interesting aspect of our story that is not always understood, however, is that we have one foot in a clearly established revenue-generating commercial business with potential for upside and another foot in an extremely promising pipeline in early-stage oncology, late-stage NASH development and life style -- life cycle management for our commercial portfolio. We firmly believe that the Phase I program evaluating our lead peptide-drug conjugate, TH1902, for treating sortilin-expressing cancers and our Phase III development program evaluating tesamorelin for the treatment of NASH, both hold true promise to benefit patient communities in areas of unmet medical need as well as our stakeholders as we continue to strengthen our foundation for growth.

謝謝你，丹尼斯。大家早上好，感謝你們今天和我們在一起。在過去的 6 個月裡，Theratechnologies 發生了很多事情，因為我們繼續整合旨在最好地優化我們的業務並為公司的長期增長定位的逐步變化。然而，我們的故事中一個有趣的方面並不總是被理解，那就是我們一隻腳踏入了一個明確建立的具有上升潛力的創收商業業務，另一隻腳踏入了一個非常有前途的早期腫瘤學管道，後期階段NASH 發展和生活方式——我們商業投資組合的生命週期管理。我們堅信，評估我們的先導肽-藥物偶聯物 TH1902 用於治療表達分選蛋白的癌症的 I 期項目和我們評估替沙莫林用於治療 NASH 的 III 期開發項目都真正有望使未滿足領域的患者社區受益醫療需求以及我們的利益相關者，因為我們繼續加強我們的增長基礎。

As we announced today, we have completed our discussions with the FDA and EMA regarding the Phase III NASH program and having finalized Phase III clinical trial design and are now in a position to finalize the protocol. As we review the additional resources that are now required to conduct a Phase III clinical trial in NASH, we decided that it was in the best interest of the company and our stakeholders to evaluate opportunities that will allow us to more effectively execute this program, including initiating a search for a potential partner for late-stage development.

正如我們今天宣布的那樣，我們已經完成了與 FDA 和 EMA 關於 III 期 NASH 計劃的討論，並完成了 III 期臨床試驗設計，現在可以完成協議。當我們審查現在在 NASH 中進行 III 期臨床試驗所需的額外資源時，我們決定評估使我們能夠更有效地執行該計劃的機會符合公司和我們的利益相關者的最大利益，包括開始尋找後期開發的潛在合作夥伴。

While this will alter the planned timing of the Phase III clinical trial initiation, which was previously expected to begin in Q3 of calendar year 2021, by seeking and securing a partner, we may potentially add additional resources and capabilities. That will be of great value as we advance this exciting program towards a potential approval. We have already kicked off this initiative and retained the services of an external U.S.-based biopharma advisory firm to assist in identifying a potential partner.

雖然這將改變 III 期臨床試驗啟動的計劃時間（此前預計該試驗將於 2021 年第三季度開始），但通過尋找和確保合作夥伴，我們可能會增加額外的資源和能力。隨著我們將這個令人興奮的計劃推進到潛在的批准，這將具有巨大的價值。我們已經啟動了這項計劃，並聘請了一家總部位於美國的外部生物製藥諮詢公司提供服務，以協助確定潛在合作夥伴。

In many ways, this may sound like a shift from our existing strategy. However, this could not be further from the truth. In prudently shaping the future of Theratechnologies, we believe that we are keeping to our strategy and our promise to best serve patients and unlock shareholders value via a two-pronged approach: innovation and growth through our commercial business and promising pipeline programs.

在許多方面，這聽起來像是對我們現有戰略的轉變。然而，這與事實相去甚遠。在審慎塑造 Theratechnologies 的未來時，我們相信我們將恪守我們的戰略和承諾，通過雙管齊下的方法為患者提供最好的服務並釋放股東價值：通過我們的商業業務和有前途的管道項目進行創新和增長。

What is most promising about our current NASH position is the fact that we have built a ready-to-proceed Phase III clinical trial design, providing a very competitive program for a future partner. In particular, tesamorelin has demonstrated a strong and well-established track record of safety and efficacy over 10 years of product data in HIV-associated lipodystrophy. We have a strong intellectual property position that was further strengthened by newly issued patents for the treatment of liver disease and extends through 2040.

我們目前的 NASH 地位最有希望的是，我們已經建立了一個隨時可以進行的 III 期臨床試驗設計，為未來的合作夥伴提供了一個非常有競爭力的項目。特別是，tesamorelin 在 HIV 相關脂肪代謝障礙的 10 年產品數據中展示了強大而完善的安全性和有效性記錄。我們擁有強大的知識產權地位，新頒發的肝病治療專利進一步鞏固了這一地位，並將延續到 2040 年。

We've collected extensive data from investigator-initiated studies in the hard-to-treat HIV NASH patient population that showed tesamorelin's unique mechanism of action that addresses the underlying cause of liver disease. With its new potential F8 formulation and multi-dose pen injector, tesamorelin could have the opportunity to provide health care providers and patients suffering from NASH and HIV-related NASH a new treatment option that may greatly improve adherence of tesamorelin and the treatment of this debilitating disease. And more importantly, we have received clarity from the U.S. and EU regulators and have finalized a comprehensive Phase III NASH trial design.

我們從研究人員發起的針對難治性 HIV NASH 患者群體的研究中收集了大量數據，這些研究表明替沙莫林具有解決肝病根本原因的獨特作用機制。憑藉其新的潛在 F8 配方和多劑量筆式註射器，tesamorelin 可能有機會為患有 NASH 和 HIV 相關 NASH 的醫療保健提供者和患者提供一種新的治療選擇，可能會大大提高 tesamorelin 的依從性和治療這種衰弱疾病。更重要的是，我們已收到美國和歐盟監管機構的明確說明，並已完成全面的 III 期 NASH 試驗設計。

In terms of regulatory discussions, the finalized Phase III trial design is planned for a multicenter, randomized, double-blind, placebo-controlled, 1:1 two-part study, designed to evaluate the safety and efficacy of tesamorelin in liver biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis. The clinical trial will also use a futility analysis that would be conducted after the first approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy. This will allow us to see if an early treatment effect with tesamorelin has been observed to determine if the study should proceed as planned.

在監管討論方面，最終確定的 III 期試驗設計計劃進行多中心、隨機、雙盲、安慰劑對照、1:1 兩部分研究，旨在評估替沙莫林在肝活檢確診患者中的安全性和有效性NAS 評分至少為 4 分且纖維化為 2 或 3 期。臨床試驗還將使用無效分析，該分析將在首批約 400 名患者完成 18 個月的治療並接受第二次肝活檢後進行。這將使我們能夠了解是否觀察到替沙莫林的早期治療效果，以確定研究是否應按計劃進行。

We will be in a position to file an sBLA after approximately 1,100 patients, including 75 to 100 people living with HIV, have completed 18 months of treatment and have received the second liver biopsy. Following potential approval, an additional 1,800 patients are expected to be enrolled to continue measuring clinical outcomes over a period of 5 years.

在大約 1,100 名患者（包括 75 至 100 名 HIV 感染者）完成 18 個月的治療並接受第二次肝活檢後，我們將能夠提交 sBLA。在可能獲得批准後，預計將招募另外 1,800 名患者，以在 5 年的時間內繼續測量臨床結果。

As I said earlier, and will reiterate again, with the feedback from the U.S. and EU regulators, we have built a launch-ready Phase III development path forward. We believe that we are creating a stronger position to unlock the intrinsic value of our NASH pipeline asset by evaluating opportunities, including identifying a potential partner to bring this ambitious program through development and toward approval. This strategy will also allow us to continue to invest and further strengthen our commercial business and advance our promising SORT1+ Technology through clinical development as quickly as possible.

正如我之前所說，並將再次重申，根據美國和歐盟監管機構的反饋，我們已經建立了一條可以啟動的第三階段發展道路。我們相信，我們正在通過評估機會，包括確定潛在合作夥伴，通過開發和批准來實現這一雄心勃勃的計劃，從而創造更強大的地位來釋放我們 NASH 管道資產的內在價值。這一戰略還將使我們能夠繼續投資並進一步加強我們的商業業務，並儘快通過臨床開發推進我們有前途的 SORT1+技術。

Turning to our oncology pipeline. We continue to be very excited about the SORT1+ Technology in sortilin-expressing cancers, and our recent discoveries garnered from preclinical work continued to confirm this opportunity. As I've said before, we believe that we have developed a targeted peptide drug conjugate that can potentially transform the way cancer is treated. Just recently, we reported preclinical in vivo findings of the anti-metastatic effect and tolerability of TH1902, further supporting TH1902's prospects as a promising cancer-killing platform technology in sortilin-expressing cancers.

轉向我們的腫瘤管道。我們仍然對 SORT1+ 技術在表達分選蛋白的癌症中的應用感到非常興奮，我們最近從臨床前工作中獲得的發現繼續證實了這一機會。正如我之前所說，我們相信我們已經開發出一種靶向肽藥物偶聯物，它有可能改變癌症的治療方式。就在最近，我們報告了 TH1902 的抗轉移作用和耐受性的臨床前體內發現，進一步支持了 TH1902 作為表達分選蛋白的癌症的有前途的癌症殺傷平台技術的前景。

These results demonstrate that TH1902 has better anti-metastatic activity when compared to docetaxel alone, when administered at equal concentrations in the lung metastasis cancer model expressing the SORT1 receptor. It is well known that the survival rate for metastatic cancer is extremely low and that SORT1 receptor expression increases as cancers progress. These new findings confirm that by targeting SORT1 receptor, TH1902 may potentially be effective in the treatment of metastasis. Most importantly, these preclinical findings, if confirm in humans, are promising signs that there may finally be a way to inhibit hard-to-treat cancers with a more effective and better-tolerated treatment and further broaden the cancer types that can potentially be treated with our SORT1+ Technology.

這些結果表明，當在表達 SORT1 受體的肺轉移癌模型中以相同濃度給藥時，與單獨使用多西紫杉醇相比，TH1902 具有更好的抗轉移活性。眾所周知，轉移性癌症的存活率極低，並且 SORT1 受體表達隨著癌症的進展而增加。這些新發現證實，通過靶向 SORT1 受體，TH1902 可能有效治療轉移。最重要的是，這些臨床前發現如果在人類身上得到證實，將是有希望的跡象，表明可能最終有一種方法可以通過更有效和更好耐受的治療來抑制難以治療的癌症，並進一步擴大可以治療的癌症類型使用我們的 SORT1+ 技術。

Our SORT1+ Technology, including TH1902, is truly groundbreaking cancer treatment approach. Based on its mechanism of action and compared to cytotoxic drugs like docetaxel or doxorubicin, TH1902 allows for increases in intracellular concentration of the cytotoxic payload, offering a different PK profile while increasing the therapeutic window of the cytotoxic drug being conjugated. What is also extremely important when comparing TH1902 to an equimolar dose concentration of a cytotoxic drug like docetaxel alone is the absence of neutropenia. In our preclinical models, TH1902 has not shown to induce neutropenia, potentially allowing for sustained treatment, better tolerability and increased efficacy of TH1902.

我們的 SORT1+ 技術（包括 TH1902）是真正具有開創性的癌症治療方法。基於其作用機制，與多西紫杉醇或多柔比星等細胞毒性藥物相比，TH1902 可增加細胞毒性有效載荷的細胞內濃度，提供不同的 PK 曲線，同時增加所結合細胞毒性藥物的治療窗口。將 TH1902 與等摩爾劑量濃度的細胞毒性藥物如多西紫杉醇單獨進行比較時，同樣非常重要的是沒有出現中性粒細胞減少症。在我們的臨床前模型中，TH1902 未顯示會誘發中性粒細胞減少症，這可能允許 TH1902 的持續治療、更好的耐受性和更高的療效。

In terms of what to expect next for this program, based on the current progress of the trial, we plan to provide a safety and efficacy interim readout from the Phase I Part A of the study in Q4 of this calendar year. By year-end, we expect to have completed the Part A dose escalation study to establish the maximum-tolerated dose and inform the next step of the Phase I Part B basket trial which is expected to begin in early 2022.

就該計劃的下一步預期而言，根據試驗的當前進展，我們計劃在本日曆年第四季度提供研究第一階段 A 部分的安全性和有效性中期讀數。到年底，我們預計將完成 A 部分劑量遞增研究，以確定最大耐受劑量，並為預計將於 2022 年初開始的 I 階段 B 部分籃子試驗的下一步提供信息。

When we think about the potential runway for growth that is ahead of us, especially as we move our pipeline of potential medicines closer to approval, it is helpful and insightful to look back at how the biotech market has matured in the last decade. One thing of note that has stood out in the last few years is just how resilient the biotech industry has been. This is the case whether we're talking about driving innovation in health care or talking about biotech's legitimacy as an investment class. Investors are looking to the sector for sources of new technology, innovation and approaches that will transform patients' life.

當我們考慮擺在我們面前的潛在增長跑道時，尤其是當我們將我們的潛在藥物管線更接近批准時，回顧過去十年生物技術市場的成熟情況是有幫助和有見地的。過去幾年值得注意的一件事是生物技術行業的彈性。無論我們是在談論推動醫療保健領域的創新，還是在談論生物技術作為投資類別的合法性，情況都是如此。投資者正在該行業尋找能夠改變患者生活的新技術、創新和方法的來源。

At Theratechnologies, we have aligned our own way forward with these ideas in mind to keep up with change, drive innovation and evolve our business in anticipation of the strong growth that is to come. We've taken cues from the biotech industry historically and modeled best-in-class standards that place a strong emphasis on the need to address 3 key areas of importance. The first is building talent, second is handling complexity and finally, improving commercial and development execution.

在 Theratechnologies，我們根據這些想法調整了自己的前進方向，以跟上變化、推動創新和發展我們的業務，以期實現強勁增長。我們從歷史上借鑒了生物技術行業的經驗，並製定了一流的標準，這些標準強調需要解決 3 個重要的關鍵領域。首先是培養人才，其次是處理複雜性，最後是提高商業和開發執行力。

On this first area of importance, we've placed a strong emphasis on near-term execution to best position ourselves for success. When you look at our recent investment, which extends our human capital, we have brought on experienced talent that are assuming critical leadership roles ensuring the successful execution of our strategic objectives.

在第一個重要領域，我們非常重視近期執行，以便為成功做好最佳準備。當您查看我們最近的投資時，這些投資擴展了我們的人力資本，我們引進了經驗豐富的人才，他們擔任關鍵的領導角色，確保成功執行我們的戰略目標。

Recently, we welcomed André Dupras as a Vice President, who will lead our Human Resources function. Mr. Dupras brings more than 25 years of experience and was most recently Vice President of Human Resources at Clementia Pharmaceuticals. André will ensure that we are attracting the very best talent in the industry to help us grow the business, and he will ensure that we retain our current exceptional group of employees. In addition, Daniel Böck was brought on to lead our Business and Corporate Development efforts. In this new creative role, Daniel will support the company's commercial and R&D strategic partnerships and alliances and assist in building out our relationships in the industry. Having strong leadership in these key positions gives us the ability to manage the complexity of operating a commercial and R&D business through the pandemic and beyond. We really look forward to their leadership and the contributions that they will bring to Theratechnologies in their respective field and roles.

最近，我們迎來了 André Dupras 擔任副總裁，他將領導我們的人力資源職能。Dupras 先生擁有超過 25 年的經驗，最近擔任 Clementia Pharmaceuticals 人力資源副總裁。André 將確保我們吸引業內最優秀的人才來幫助我們發展業務，他還將確保我們留住現有的優秀員工團隊。此外，Daniel Böck 還負責領導我們的業務和企業發展工作。在這個新的創意角色中，丹尼爾將支持公司的商業和研發戰略合作夥伴關係和聯盟，並協助建立我們在行業中的關係。在這些關鍵職位上擁有強大的領導能力，使我們能夠在大流行病及以後管理商業和研發業務運營的複雜性。我們非常期待他們的領導力以及他們將在各自領域和角色中為 Theratechnologies 做出的貢獻。

Turning to the second area of importance, handling complexity. I think nearly every company in every industry can point out to the COVID-19 pandemic as a prime example of how the organization has handled complexity during this time. For us, this has been centered around our commercial business. To that end, Symphony, one of the leading data providers for the industry, published data on office visits pertaining to HIV diagnosis during the pandemic. Looking at the data, the most significant takeaway related to our company was that through 2020 and into early 2021 overall genomic resistance testing was down 25% compared to previous periods.

轉向第二個重要領域，處理複雜性。我認為幾乎每個行業的每個公司都可以指出 COVID-19 大流行是該組織在此期間如何處理複雜性的主要例子。對我們來說，這一直以我們的商業業務為中心。為此，該行業領先的數據提供商之一 Symphony 發布了大流行期間與 HIV 診斷有關的辦公室訪問數據。從數據來看，與我們公司相關的最重要的收穫是，到 2020 年和 2021 年初，整體基因組耐藥性測試比前幾個時期下降了 25%。

This is pretty significant that this data serves as a general proxy for our industry and at a high level is indicative of the pervasive challenges that we faced in the first half of this year. As many of you are aware, genomic testing is a prerequisite for initiating specialty HIV drug treatments like Trogarzo.

這非常重要，因為該數據可以作為我們行業的一般代表，並且在較高水平上表明我們在今年上半年面臨的普遍挑戰。正如你們中的許多人所知，基因組測試是啟動像 Trogarzo 這樣的特殊 HIV 藥物治療的先決條件。

During the second quarter, we continued to see this impact our top line results, in particular Trogarzo as patient prerequisite testing continued to be hindered by the pandemic-related strains on health care facilities and physicians. The introduction of competitive pressures from newly launched therapies for the treatment of HIV may have also impacted the U.S. sales performance of Trogarzo during the quarter.

在第二季度，我們繼續看到這對我們的頂線結果產生影響，特別是 Trogarzo，因為患者先決條件測試繼續受到與大流行相關的醫療機構和醫生壓力的阻礙。新推出的治療 HIV 的療法帶來的競爭壓力可能也影響了 Trogarzo 在本季度在美國的銷售業績。

In the EU, we continue to work toward obtaining an appropriate price and widespread reimbursement for Trogarzo in key European countries, and believe we have created a strong foundation for our medicines for when the pandemic-associated lockdown measures are fully lifted. Nonetheless, both in the U.S. and EU, we have continued to enhance our medical liaison teams and community outreach engagements as we look to build this area further as patients get ready to resume doctors' appointments again. Concurrently, we continue to prepare HCPs to be better informed and with better resources to prescribe our medicines, helping to ensure that patients adhere to prescribe treatment plans as they move through their patient journeys in the effort to improve their overall health.

在歐盟，我們繼續努力在歐洲主要國家為 Trogarzo 獲得適當的價格和廣泛的報銷，並相信我們已經為我們的藥物奠定了堅實的基礎，以應對與大流行相關的封鎖措施的全面解除。儘管如此，在美國和歐盟，我們都在繼續加強我們的醫療聯絡團隊和社區外展活動，因為我們希望在患者準備好再次恢復醫生預約時進一步建設這一領域。同時，我們繼續讓 HCP 做好準備，以便更好地了解情況並擁有更好的資源來開我們的藥，幫助確保患者在他們的患者旅程中遵守處方治療計劃，以努力改善他們的整體健康狀況。

As I touch upon the third and final key area of importance, improving commercial and development execution, we continue to take the necessary proactive measures to build out our commercial business while being mindful that the short-term impact of COVID on the industry may continue in the U.S. and EU until we have fully exited the sustained challenges related to the pandemic.

當我談到第三個也是最後一個重要的關鍵領域，即提高商業和開發執行力時，我們將繼續採取必要的積極措施來建立我們的商業業務，同時注意 COVID 對行業的短期影響可能會持續到美國和歐盟，直到我們完全擺脫與大流行病相關的持續挑戰。

When we think about where we want to be with regards to sales following a full exit from the pandemic, we remain optimistic. We believe the sales, marketing and educational support infrastructure that we've built started to bear fruit on EGRIFTA SV sales during this quarter, which grew 12% over 2020. We are encouraged by the incremental gains in EGRIFTA SV sales in the first half of the year and believe that this is indicative of our patient activation efforts and digital strategy to support patients to initiate our therapy.

當我們考慮在完全擺脫大流行之後我們希望在銷售方面達到什麼水平時，我們仍然保持樂觀。我們相信，我們建立的銷售、營銷和教育支持基礎設施在本季度開始對 EGRIFTA SV 的銷售額產生影響，該銷售額比 2020 年增長了 12%。我們對今年上半年 EGRIFTA SV 銷售額的增量收益感到鼓舞，並相信這表明我們的患者激活工作和數字戰略支持患者開始我們的治療。

These continued efforts around our HIV business are intended to be catalysts for a steady and incremental ramp-up in revenues going forward and will also serve to reduce execution risk all the way through to the commercial stages of our pipeline candidates. We are firmly grounded in these near- and long-term initiatives. And we are executing on our strategic operating plans accordingly while efficiently deploying capital and managing operating expenses.

圍繞我們的 HIV 業務的這些持續努力旨在成為未來收入穩定和增量增長的催化劑，並將有助於降低執行風險，一直到我們的管道候選人的商業階段。我們堅定地支持這些近期和長期舉措。我們正在相應地執行我們的戰略運營計劃，同時有效地部署資本和管理運營費用。

Looking at the overall business, I believe we have made valuable progress in 2021 thus far. And I can say with true conviction that we have executed against our strategy as reflected in a better, stronger organization with a talent pool that is aligning with our growth trajectory and ambition.

縱觀整體業務，我相信到目前為止，我們在 2021 年取得了有價值的進展。我可以堅定地說，我們已經按照我們的戰略執行，這反映在一個更好、更強大的組織中，其人才庫與我們的增長軌跡和雄心相一致。

With this, I would like to turn the call over to Philippe now to discuss the second quarter results. Philippe, please go ahead.

有了這個，我想現在把電話轉給菲利普來討論第二季度的結果。菲利普，請繼續。

Thanks, Paul, and good morning, everyone. Consolidated revenues for the second quarter of fiscal 2021 were $17.8 million, an increase of 4% over Q2 2020, mostly due to an increase in EGRIFTA SV sales and hampered by lower sales of Trogarzo. Net sales of EGRIFTA SV were $10.3 million, up 12% from the same period last year when we recorded sales of $9.3 million. Unit sales of EGRIFTA were relatively stable compared to last year, but net sales were better due to a higher net selling price and lower rebates to government payers, given the switch from EGRIFTA SV from the old version of EGRIFTA, which carried higher percentage discounts than EGRIFTA SV.

謝謝，保羅，大家早上好。2021 財年第二季度的合併收入為 1780 萬美元，比 2020 年第二季度增長 4%，這主要是由於 EGRIFTA SV 銷售額的增加以及 Trogarzo 銷售額下降的影響。EGRIFTA SV 的淨銷售額為 1030 萬美元，比去年同期的 930 萬美元增長 12%。與去年相比，EGRIFTA 的單位銷售額相對穩定，但由於從舊版 EGRIFTA 的 EGRIFTA SV 轉換為 EGRIFTA SV 的淨銷售價格更高和對政府付款人的回扣較低，淨銷售額更好，其折扣百分比高於EGRIFTA SV。

Trogarzo revenues were down 6% year-over-year as a result of lower sales to specialty pharmacies, the effect of the ongoing COVID-19 pandemic resulting in difficulty for patients to visit health care facilities to meet with physicians and obtain their intravenous infusion, competitive pressures and slightly higher rebates as well. These factors were partially offset by a higher selling price. And recall that in Q2 2020, at the beginning of the pandemic, net sales of Trogarzo were positively impacted by unusually large orders by pharmacies, which have since stabilized. In the EU, while the COVID situation is still problematic, mostly with respect to patients getting onboarded on therapy, our team in Europe continues to identify patients. We believe that the latter part of the year may provide incremental gains.

Trogarzo 的收入同比下降 6%，原因是專業藥店的銷售額下降，持續的 COVID-19 大流行導致患者難以前往醫療機構與醫生會面並獲得靜脈輸液，競爭壓力和略高的回扣也是如此。這些因素部分被更高的售價所抵消。回想一下，在 2020 年第二季度，即大流行開始時，Trogarzo 的淨銷售額受到藥店異常大訂單的積極影響，此後已經穩定下來。在歐盟，雖然 COVID 情況仍然存在問題，主要是與接受治療的患者有關，但我們在歐洲的團隊仍在繼續識別患者。我們認為今年下半年可能會提供增量收益。

Pricing discussions are progressing in the EU and reception has been positive. With this in mind, we have laid the groundwork to growing revenues of the Theratechnologies franchise and expect to see our efforts bear fruit from these strategic initiatives.

定價討論在歐盟取得進展，反響良好。考慮到這一點，我們已經為 Theratechnologies 特許經營收入的增長奠定了基礎，並期望看到我們的努力從這些戰略舉措中取得成果。

Cost of sales in Q2 2021 was down to $5.9 million compared to $7.3 million for the same quarter last year. The decrease is mostly due to higher gross margins on EGRIFTA SV compared to EGRIFTA as well as a lower transfer price for Trogarzo given the achievement of a predetermined amount of net sales in Q3 of last year.

2021 年第二季度的銷售成本降至 590 萬美元，而去年同期為 730 萬美元。下降的主要原因是 EGRIFTA SV 的毛利率高於 EGRIFTA 以及 Trogarzo 的轉讓價格較低，因為去年第三季度實現了預定的淨銷售額。

R&D expenses amounted to $6.4 million in Q2 2021 compared to $3.6 million for the same quarter last year. This increase is largely due to higher spending in oncology with the initiation of our Phase I trial, increased activity related to our NASH program including on the new F8 formulation, increased spending in medical and patient education as well as higher medical affairs initiatives in Europe.

2021 年第二季度的研發費用為 640 萬美元，而去年同期為 360 萬美元。這一增長主要是由於隨著我們的 I 期試驗的啟動，腫瘤學支出增加，與我們的 NASH 計劃相關的活動增加，包括新的 F8 配方，醫療和患者教育支出增加以及歐洲更高的醫療事務計劃。

For the 3-month period ended May 31, 2021, selling expenses were on par with Q2 2020 and were stable at $6.9 million.

在截至 2021 年 5 月 31 日的三個月期間，銷售費用與 2020 年第二季度持平，穩定在 690 萬美元。

G&A expenses amounted to $3.9 million in Q2, up slightly from $3.7 million in Q2 2020. The increase in G&A expenses is largely due to increased overall business activity in 2021 compared to 2020. This increase is partly offset by onetime items incurred in 2020 as a result of the retirement of the company's previous CEO.

第二季度的 G&A 費用為 390 萬美元，略高於 2020 年第二季度的 370 萬美元。G&A 費用的增加主要是由於與 2020 年相比，2021 年的整體業務活動有所增加。由於公司前任首席執行官退休，2020 年發生的一次性項目部分抵消了這一增長。

In Q2 2021, we recorded $1 million in net finance costs compared to $1.4 million in Q2 2020. As previously stated, finance costs comprise of interest on convertible notes as well as accretion expense. Net finance costs in 2021 were reduced by foreign exchange gains of $378,000. For the second quarter of 2021, we recorded a negative EBITDA of $2.6 million compared to negative $1.5 million last year. This difference is mainly due to a higher net loss during the quarter.

2021 年第二季度，我們錄得 100 萬美元的淨財務成本，而 2020 年第二季度為 140 萬美元。如前所述，財務成本包括可轉換票據的利息和增值費用。2021 年的淨財務成本因匯兌收益 378,000 美元而減少。2021 年第二季度，我們錄得 260 萬美元的負 EBITDA，而去年為負 150 萬美元。這一差異主要是由於本季度淨虧損增加所致。

For the second quarter of 2021, our operations, including variations in working capital, used approximately $700,000 of cash, which explains why our cash balance has remained virtually identical to that of February 28, 2021, at approximately $57 million.

在 2021 年第二季度，我們的運營（包括營運資金的變化）使用了大約 700,000 美元的現金，這解釋了為什麼我們的現金餘額幾乎與 2021 年 2 月 28 日相同，約為 5700 萬美元。

I will now turn the call back to Paul for some closing remarks.

我現在將把電話轉回給保羅，聽取一些結束語。

Thank you, Philippe. Looking back at the first half of the year, we're pleased with the organization that we have become. Innovation that we are developing is really special and has the ability to greatly improve and in many instances, transform patients' lives across areas of high unmet medical need. As we look to carry this momentum through the remainder of 2021, I am ever the more confident that we will improve our commercial business while advancing our research pipeline.

謝謝你，菲利普。回顧今年上半年，我們對我們所成為的組織感到滿意。我們正在開發的創新非常特別，能夠極大地改善並在許多情況下改變患者在醫療需求未得到滿足的領域的生活。當我們希望在 2021 年剩餘時間內保持這種勢頭時，我更加相信我們將在推進研究渠道的同時改善我們的商業業務。

In the short term, our priorities remain focused on delivering growth from our commercial portfolio, completing the dose escalation part of our oncology trial, and of course, exploring opportunities, including finding a potential partner to maximize the value of our Phase III NASH program.

在短期內，我們的優先事項仍然集中在通過我們的商業產品組合實現增長，完成我們腫瘤學試驗的劑量遞增部分，當然還有探索機會，包括尋找潛在合作夥伴以最大化我們 III 期 NASH 計劃的價值。

And with that, we will now open the call to take your questions. (Operator Instructions)

有了這個，我們現在將打開電話來回答你的問題。（操作員說明）

(Operator Instructions) Our first question comes from Andre Uddin with Research Capital.

（操作員說明）我們的第一個問題來自 Research Capital 的 Andre Uddin。

In terms of your NASH potential partnership, which I think is actually a great idea, can you please describe your ideal partner? Will you look for them to fully fund the Phase III trial or will you look to co-develop it and then later co-promote it? And also with this potential partner, would you look to co-promote EGRIFTA for HIV?

就你的 NASH 潛在合作夥伴而言，我認為這實際上是一個好主意，你能描述一下你理想的合作夥伴嗎？您會尋求他們為 III 期試驗提供全部資金，還是希望他們共同開發然後共同推廣？還有這個潛在的合作夥伴，你會期待共同推廣 EGRIFTA 治療艾滋病毒嗎？

Well, thank you, Andre, for the question, and I'm glad you feel that way. This is certainly a position of strength that we're facing at this time. We have an approved protocol in our lab. There are not too many companies that can actually, in such an area of unmet medical need, be in a position like this. When it comes down to the ideal partner, I think that it can take different forms. And it's kind of too early to actually take a look at all the possibilities that are ahead.

好吧，謝謝安德烈提出這個問題，我很高興你有這樣的感覺。這無疑是我們此時面臨的一個優勢地位。我們的實驗室有一個批准的協議。在這樣一個醫療需求未得到滿足的領域，能夠真正處於這樣的位置的公司並不多。當談到理想的合作夥伴時，我認為它可以有不同的形式。現在真正審視未來的所有可能性還為時過早。

But they're certainly the one that comes with co-development, co-promotion, co-commercialization down the road. Other companies may decide to actually that they want to invest, but they would want us to continue the development and maybe have a piece of the commercialization later on.

但它們肯定是伴隨著共同開發、共同推廣、共同商業化而來的。其他公司可能會決定實際上他們想要投資，但他們希望我們繼續開發並可能在以後進行商業化。

So I think that we have -- already with our adviser, have done a mapping of the potential pharmaceutical companies, big companies, medium-sized, with an interest in NASH and we know what these companies are. And I think that we'll see down the road what type of partnership we can sign with them. But one thing is for sure, nobody knows tesamorelin more than we do. So we need to actually keep investing, keep unfolding our plan and we're fully committed to put that to life with a partner with other means that we're going to find in the upcoming months.

所以我認為我們已經——已經和我們的顧問一起，對潛在的製藥公司、大公司、中型公司進行了映射，對 NASH 感興趣，我們知道這些公司是什麼。而且我認為我們會看到我們可以與他們簽署什麼樣的合作夥伴關係。但有一件事是肯定的，沒有人比我們更了解替沙莫林。因此，我們實際上需要繼續投資，繼續展開我們的計劃，我們完全致力於與合作夥伴一起將其付諸實踐，我們將在未來幾個月內找到其他方式。

Okay. And just also on the business development front, are you looking to add any new commercial-stage products that you think would fit with your current sales force?

好的。同樣在業務發展方面，您是否希望添加您認為適合您當前銷售團隊的任何新的商業階段產品？

The answer is yes. We are on the lookout, and this is a strategy that makes a lot of sense for us because we've got 2 products in the bag in the U.S. We have only 1 product in Europe. So we'll take a look at how we can identify what I call a drug companion that could actually synergize with the portfolio that we have and that would increase the critical mass of assets that would make sense for the target of doctors that we are calling on at this time. So we will actually do some work. We've already started. Again, the pandemic made some of that more complicated, but we will look into it. And we'll see if we find that sweet spot again with the ideal companion.

答案是肯定的。我們正在尋找，這個策略對我們來說很有意義，因為我們在美國有 2 種產品，而我們在歐洲只有 1 種產品。因此，我們將研究如何確定我所說的藥物伴侶，它實際上可以與我們擁有的產品組合產生協同作用，並且會增加對我們所稱的醫生目標有意義的資產的臨界質量在這個時候。所以我們實際上會做一些工作。我們已經開始了。同樣，大流行使其中一些變得更加複雜，但我們將對其進行調查。我們會看看我們是否能再次找到理想伴侶的甜蜜點。

Okay. And just also, one last question here. I just saw that there is an EGRIFTA Phase II trial being run with 100 HIV patients with MCI, or mild cognitive impairment. Can you discuss how this trial came about and when the results for that trial are expected roughly, if you know?

好的。還有，最後一個問題。我剛剛看到有一項 EGRIFTA II 期試驗正在對 100 名患有 MCI 或輕度認知障礙的 HIV 患者進行。如果您知道，您能否討論一下這項試驗是如何進行的，以及該試驗的大致預期結果是什麼時候？

Christian, do you want to handle, please?

克里斯蒂安，你想處理嗎？

Absolutely. Yes, Andre. Thank you for the question. I don't know, Andre, if you remember, but we have done first, a number of years ago, a study in non-HIV in the general population in mild cognitively impaired patients with Dr. Vitiello and we have shown positive results. Following that study, there are also studies showing in HIV that an increased waist circumference is also associated with mild cognitive impairment and Dr. [Fred Schaerf] and Ron Ellis have been working with us to start that trial. And that trial has been ongoing for a number -- probably about 2 years now. We hope that the recruitment will be completed in 2022, and it is a 6-month study, then we should potentially see results in 2023. And it's a good rationale for -- based on the preceding studies that were done with EGRIFTA.

絕對地。是的，安德烈。感謝你的提問。我不知道，安德烈，你是否記得，但我們首先在幾年前與 Vitiello 博士一起對輕度認知障礙患者的一般人群進行了一項非 HIV 研究，我們取得了積極的結果。在這項研究之後，還有研究表明，在 HIV 中，腰圍增加也與輕度認知障礙有關，[Fred Schaerf] 博士和 Ron Ellis 博士一直在與我們合作開始這項試驗。該試驗已經進行了一段時間——現在可能大約 2 年了。我們希望招募能在 2022 年完成，這是一項為期 6 個月的研究，然後我們可能會在 2023 年看到結果。這是一個很好的理由——基於之前對 EGRIFTA 所做的研究。

So all the patients in that trial are HIV?

那麼該試驗中的所有患者都是 HIV？

All the patients in that trial are HIV. It is linked to a study that Dr. Ron Ellis -- epidemiological study that Dr. Ron Ellis had done in the past showing the link between increased waist circumference,which is increased visceral adipose tissue or ectopic fat, and decrease in cognition.

該試驗中的所有患者都是 HIV。這與 Ron Ellis 博士的一項研究有關——Ron Ellis 博士過去所做的流行病學研究表明，腰圍增加（即內臟脂肪組織或異位脂肪增加）與認知能力下降之間存在聯繫。

Our next question comes from Edward Nash with Canaccord Genuity.

我們的下一個問題來自 Edward Nash 和 Canaccord Genuity。

So I wanted to understand -- so I know that we just got the protocol now approved, I guess, officially, but we've known since roughly almost a year ago now that you were not going to be allowed -- or the agency was not going to be receptive to you looking at only NASH patients that were the head HIV. So I'm just trying to understand now that you're deciding to partner -- I mean, your cash balance is what it is, which is going to drive the decision. But we already kind of knew what your cash balance was then, too. So just what's changed between -- since last year and now with regards to your decision to look for a partner for the Phase III NASH?

所以我想了解 - 所以我知道我們現在剛剛批准了協議，我想，是正式的，但我們從大約一年前就知道你不會被允許 - 或者該機構是不會接受你只看 NASH 患者的頭 HIV。所以我現在只是想了解你決定合作 - 我的意思是，你的現金餘額就是這樣，這將推動決定。但我們當時也已經知道您的現金餘額是多少。那麼，從去年到現在，關於您為 III 期 NASH 尋找合作夥伴的決定之間發生了什麼變化？

Well, thank you very much. Listen, what has changed is that the cohort size now has increased. And through the negotiation with the agencies, they've asked for additional monitoring to be done. And the monitoring is something that we had partially anticipated, but that's the type of thing that comes out when you negotiate with the agencies. All of that is increasing costs just about 25%. 25% over the period of time of that trial is significant. And I think that this is the sweet spot now that we are facing because we have a protocol that is ready to proceed. And I think that if there is a moment where we can, with credibility, attract and discuss with a potential partner, it is now.

好的，謝謝。聽著，改變的是隊列規模現在增加了。通過與這些機構的談判，他們要求進行額外的監控。監控是我們部分預料到的，但這是你與機構談判時出現的那種事情。所有這些只增加了大約 25% 的成本。在該試驗期間的 25% 是顯著的。我認為這是我們現在面臨的最佳點，因為我們有一個準備好繼續進行的協議。而且我認為，如果有一個時刻我們可以憑藉信譽吸引潛在合作夥伴並與其進行討論，那就是現在。

Having done that 6 months ago, we were in the midst of interacting with the agencies at that time. So first thing that they would have asked is tell me more. And I think that we would like to see if the partner wants to actually be part of the beginning of that trial. So this is the moment that we're in. It's the ideal time. I think that if the partner would like to team up, take a look at the protocol, it's not too late. We can do different things if needed. But the protocol is ready to proceed, and we have all the confidence in the world that this protocol will tip this to an approval.

6 個月前完成該操作後，我們當時正在與各機構進行互動。所以他們會問的第一件事就是告訴我更多。而且我認為我們想看看合作夥伴是否真的想參與該試驗的開始。所以這就是我們所處的時刻。這是理想的時間。我覺得如果搭檔想組隊，看看協議，現在也不晚。如果需要，我們可以做不同的事情。但該協議已準備好繼續進行，我們對世界充滿信心，該協議將促使其獲得批准。

So going back to your question, I think that what has changed is the additional cost, the complexity of this trial. And I think it's prudent and probably a good thing that we explore the opportunity of having a partner in at this time. Thank you for your question.

所以回到你的問題，我認為改變的是額外的成本，這個試驗的複雜性。而且我認為我們在這個時候探索有合作夥伴的機會是謹慎的，而且可能是一件好事。謝謝你的問題。

No. I think that was helpful. And I guess the second part to that is just with regards to modeling this, I mean, obviously, this could go -- this can take many different forms, as you mentioned. But of the 6 Phase III -- 6 companies running Phase IIIs right now for NASH, they're all in this alone. And I just wanted to know on that side, have you already guys -- have you already had people having accessed the data on a confidential basis showing interest? Or is this kind of an effort that now that you have a BD guy on board, is this something that's just now starting new from scratch?

不。我認為這很有幫助。我想第二部分只是關於建模，我的意思是，很明顯，這可能會發生——正如你提到的，這可以採取許多不同的形式。但是在 6 家 III 期——6 家公司正在為 NASH 運行 III 期，他們都在這一個。我只是想知道在這方面，你們有沒有人——你們是否已經有人在保密的基礎上訪問了數據並表現出興趣？還是現在您已經有了 BD 人員，這是一種努力，這是剛剛從頭開始的新事物嗎？

Well, I'm not going to get into the detail, but the outreach has started and the discussions are ongoing. And I cannot reveal where we are. But this is serious stuff. There is a fair amount of interest at this time, and we're going to go through the process step-wise, and we'll let you know once we have more to say.

好吧，我不打算詳細介紹，但外展活動已經開始，討論仍在進行中。我不能透露我們在哪裡。但這是嚴肅的事情。目前有相當多的興趣，我們將逐步完成該過程，一旦我們有更多要說的，我們會通知您。

Got it. That's great. And then my last question is just with regard to the F8 formulation, the pen formulation, can you remind us again when you expect to have that available for -- to replace the EGRIFTA SV?

知道了。那太棒了。然後我的最後一個問題是關於 F8 配方，鋼筆配方，你能否再次提醒我們，當你希望用它來取代 EGRIFTA SV 時？

Christian, do you want to...

克里斯蒂安，你想...

Yes. Absolutely. The plan is to submit the dossier in the first quarter of 2022, then it should be available. It's a 5-month review, then it should be available towards the third -- fourth quarter of 2022. And the main reason is that we need to gather more stability like the F8 is relatively new, and we are gathering stability data for the shelf-life.

是的。絕對地。計劃在 2022 年第一季度提交檔案，屆時應該可以使用。這是一個為期 5 個月的審查，然後它應該在 2022 年第三 - 第四季度可用。主要原因是我們需要收集更多的穩定性，比如 F8 相對較新，我們正在收集保質期的穩定性數據。

Our next question comes from Endri Leno with National Bank.

我們的下一個問題來自國家銀行的 Endri Leno。

I'll pick up again with the NASH, and I have a couple more after that. But a question I had is that what possibility do you guys foresee that a partner may ask for a general NASH data prior to an agreement?

我會再次選擇 NASH，之後我還會有更多。但我的一個問題是，你們預見到合作夥伴在達成協議之前可能會要求提供一般 NASH 數據的可能性有多大？

Would you mind repeating your question because the line wasn't all that clear and we couldn't hear you very well.

你介意重複你的問題嗎，因為線路不是很清楚，我們聽不太清楚。

Sure. Yes. So what is the possibility that you guys foresee that a partner may ask for a general NASH data prior to an agreement?

當然。是的。那麼你們預見到合作夥伴在達成協議之前可能會要求提供一般 NASH 數據的可能性有多大？

Well, I mean this is an interesting question, but we've got a ready-to-proceed protocol at this time that has been negotiated. So I think that the 2 agencies were pleased with what we actually presented in front of them. And quite frankly, over the last 12 months, we have broadened our support for tesamorelin in the general population. You would remember that to get to this point it's been a pretty long journey. We started with having interest in NASH in the HIV population. And based with -- based on our early interaction with the agencies, we actually were told that we should actually think about the general population. And we actually look forward to that, and we ended up broadening our support among the experts in the industry. And I think now we're all set to go. Christian, do you want to add anything?

好吧，我的意思是這是一個有趣的問題，但我們目前已經商定了一個隨時可以進行的協議。所以我認為這 2 個機構對我們實際呈現在他們面前的內容感到滿意。坦率地說，在過去的 12 個月裡，我們擴大了對普通人群對替沙莫林的支持。您會記得，要達到這一點，這是一段相當漫長的旅程。我們首先對 HIV 人群中的 NASH 感興趣。並且基於 - 基於我們與機構的早期互動，我們實際上被告知我們應該考慮普通人群。我們真的很期待這一點，我們最終擴大了對行業專家的支持。我想現在我們都準備好了。克里斯蒂安，你想補充什麼嗎？

Yes. Maybe, Endri, just to -- I'll go back on the scientific side and the mechanism of action. There is a clear association between decreased release in GH and increased visceral adipose tissue and increase in liver fat in both patient population, non-HIV and HIV. And that's really the mechanism of action that we're targeting. The other thing that we have done so far, we have done a study with EGRIFTA in both HIV and non-HIV. In both patient population, we have shown a good similar decrease in visceral adipose tissue. And in the HIV population, we have shown the decrease in liver fat of about 40%, which we think it is the same because there's a good correlation between the decrease in visceral adipose tissue and liver fat. Therefore, in the general population, it should be similar.

是的。也許，恩德里，只是為了 - 我會回到科學方面和行動機制。在非 HIV 和 HIV 患者人群中，GH 釋放減少與內臟脂肪組織增加以及肝臟脂肪增加之間存在明顯關聯。這確實是我們所針對的行動機制。到目前為止我們所做的另一件事是，我們在 HIV 和非 HIV 中使用 EGRIFTA 進行了研究。在這兩個患者群體中，我們都顯示出內臟脂肪組織的良好相似減少。在 HIV 人群中，我們已經顯示肝臟脂肪減少了大約 40%，我們認為這是相同的，因為內臟脂肪組織的減少和肝臟脂肪之間有很好的相關性。因此，在一般人群中，應該是差不多的。

And all of our experts that we work -- independent experts that we worked with told us that this is the best way and the best approach to go then. We're very confident with the data that we have, and it was supported by the regulatory agencies that we can go ahead and move in the general population.

我們工作的所有專家——與我們合作的獨立專家都告訴我們，這是最好的方法，也是最好的方法。我們對我們擁有的數據非常有信心，並且得到了監管機構的支持，我們可以繼續在普通人群中移動。

Okay. Great. Actually one more, perhaps for Christian. If you can please refresh us on the current endpoint as per the last protocol versus your prior expectations and the results already obtained in Trogarzo for NASH, please?

好的。偉大的。實際上還有一個，也許是給克里斯蒂安的。如果您可以根據上一個方案與您之前的預期以及已經在 Trogarzo 中獲得的 NASH 結果相比，請刷新我們的當前端點，好嗎？

Yes. For -- you mean for the EGRIFTA NASH in terms of the endpoint for the Phase III trial?

是的。對於——你的意思是 EGRIFTA NASH 就 III 期試驗的終點而言？

Yes, please.

是的，請。

Yes. What we're looking at, at the moment is a normalization in the NAS score. Patients will be -- will have an NAS score of 4 and more at the entry and fibrosis of 2 or 3. We're looking at the normalization of NASH in 10% of the patient. This is a primary endpoint without a negative impact on fibrosis. But fibrosis will also be assessed, and fibrosis will be a secondary endpoint. And based on the data and recent publication from Dr. Loomba, we know that the decrease of 30% in liver fat is associated with normalization of NASH and it's also associated with decrease of fibrosis. Then we're quite confident in those 2 endpoints for the Phase III program.

是的。我們目前看到的是 NAS 分數的標準化。患者將——進入時的 NAS 評分為 4 分或更高，纖維化為 2 或 3 分。我們正在觀察 10% 的患者 NASH 的正常化。這是對纖維化沒有負面影響的主要終點。但纖維化也將被評估，纖維化將是次要終點。根據 Loomba 博士的數據和最近發表的文章，我們知道肝臟脂肪減少 30% 與 NASH 正常化有關，也與纖維化減少有關。那麼我們對 III 期項目的這兩個終點非常有信心。

Got it. Great. My other question is more to do with the sales in the quarter for Trogarzo. I don't know if you guys are able to provide a bit of a breakdown on the 6% decline. And how much of that was due to lower volumes, how much was due to competition and then rebates?

知道了。偉大的。我的另一個問題更多地與 Trogarzo 本季度的銷售額有關。我不知道你們是否能夠對 6% 的下降提供一些細分。其中有多少是由於銷量下降，有多少是由於競爭和回扣？

Philippe, do you have a few -- I think you had a few statements in your speech. Can you go ahead?

菲利普，你有沒有——我想你在演講中有一些陳述。你能繼續嗎？

Sure. Sure. So Endri, it's really a mix of everything. So we are -- we did see lower unit volumes. Trogarzo has been more affected by the pandemic, especially if -- when immunocompromised patients are told to stay at home. So that was affected -- it affected the unit sales, it affected new prescriptions as well. Remember, last year, there was a huge spike in orders from pharmacies at the beginning of the pandemic. So that kind of normalled out a little bit between -- during that quarter last year. But still inventory levels at the end of last quarter were kind of high. So it's really a mix of everything that resulted in this minus 6% in sales.

當然。當然。所以恩德里，它真的是一切的混合體。所以我們 - 我們確實看到了較低的單位數量。Trogarzo 受到大流行的影響更大，尤其是當免疫功能低下的患者被告知待在家裡時。所以這受到了影響——它影響了單位銷售，它也影響了新的處方。請記住，去年大流行開始時藥店的訂單激增。所以這種情況在去年那個季度之間有點正常化。但上個季度末的庫存水平仍然很高。因此，這實際上是導致銷售額下降 6% 的所有因素的混合體。

Okay. No, great. But as we look more into -- I mean specially volumes, like what are you seeing or what do you expect to see over the next few quarters? I mean given that most of the things were pretty much open in the U.S. the last quarter and as we see new cases starting to ramp up a little bit, I mean should we expect sales or volumes at least flattish or a bit below or a bit up, trending upwards?

好的。不，太好了。但是隨著我們更多地研究 - 我的意思是特別是體積，比如你看到了什麼或者你希望在接下來的幾個季度看到什麼？我的意思是，鑑於上個季度美國的大部分業務都相當開放，而且隨著我們看到新病例開始有所增加，我的意思是我們是否應該預期銷量或銷量至少持平或略低於或略微向上，趨勢向上？

Well, thank you for the questions. We are into this for growth. So we're committed to Trogarzo. We're committed to EGRIFTA. The good news is now the field force are up and running. Again, face-to-face calls are increasing. And obviously, that's the best way we can get our messages out to our physicians and patients somehow. So we are optimistic that we're going to be firming up the performance of both assets. Things have slowed down in Europe due to the pandemic and the lockdown. Now we will resume our pricing and negotiation. What is important to me, quite frankly, is that this drug, Trogarzo, be relevant to patients and HCPs.

嗯，謝謝你的問題。我們進入這個增長。所以我們致力於 Trogarzo。我們致力於 EGRIFTA。好消息是現在現場工作人員已啟動並運行。同樣，面對面的通話也在增加。顯然，這是我們以某種方式將信息傳達給醫生和患者的最佳方式。因此，我們樂觀地認為，我們將鞏固這兩種資產的表現。由於大流行和封鎖，歐洲的情況有所放緩。現在我們將恢復定價和談判。坦率地說，對我來說重要的是這種藥物 Trogarzo 與患者和 HCP 相關。

And we're going to work hard because we know that they need alternatives to treat their patients. So we foresee growth with both assets in the upcoming months, and we're going to work hard to make that happen. And I think that I would leave it at that for now.

我們將努力工作，因為我們知道他們需要替代方法來治療他們的病人。因此，我們預計未來幾個月這兩種資產都會增長，我們將努力實現這一目標。我想我現在會把它留在那兒。

Okay. Great. And one last one for me. If you guys can talk a little bit in terms of costs -- costs, how do you see them over the next 2, 4 quarters?

好的。偉大的。最後一張給我。如果你們能談談成本——成本，你們如何看待未來 2、4 個季度的成本？

Philippe, do you want to take that?

菲利普，你要拿那個嗎？

Yes. Well, until we start the NASH trial, I think you can pretty much assume that on the SG&A front, and even on the R&D front, it should be relatively stable. So until we do start the NASH trial, this quarter is probably a good proxy.

是的。好吧，在我們開始 NASH 試驗之前，我認為你幾乎可以假設在 SG&A 方面，甚至在研發方面，它應該是相對穩定的。因此，在我們開始 NASH 試驗之前，本季度可能是一個很好的代理。

And let me add one thing on your question again. I'd like just to say that there's new dynamics going on in HIV as new competitors are launching. But at the same time, the market is moving to long-acting. We have a long-acting compound with Trogarzo. So we're going to make sure that, that gets to our physicians and that we see the benefits of prescribing Trogarzo in the mix of drugs they need to take or to prescribe to control patients.

讓我再對你的問題補充一件事。我只想說，隨著新競爭者的出現，艾滋病病毒正在出現新的動態。但與此同時，市場正在轉向長效藥物。我們有一種含有 Trogarzo 的長效化合物。因此，我們要確保，這會影響到我們的醫生，並且我們會看到在他們需要服用或開處方以控制患者的藥物組合中開出 Trogarzo 的好處。

(Operator Instructions)

（操作員說明）

As it seems, as we do not have additional questions from analysts, we will now turn to questions submitted by other participants in writing. The first question that we have is, if there is a timeframe that you expect to finalize a partnership in NASH?

看起來，由於我們沒有分析師的額外問題，我們現在將轉向其他參與者以書面形式提交的問題。我們的第一個問題是，您是否希望在 NASH 中完成合作夥伴關係的時間表？

Well, as we said today, I think it should be clear that we are going to look at all the options that we have. As I said, we are in a position of strength. It's very important that we take a little bit of time now and somehow even slow down to better accelerate in a few months. This is a long journey. So if we can find a partner that will bring resources but also capabilities, I think that the slowing down aspect of this will be forgotten very, very fast. So what is more important for us, at this time, it's really to find the ideal partner. And I think that time line will take care of itself along the way.

好吧，正如我們今天所說，我認為應該明確的是，我們將研究我們擁有的所有選項。正如我所說，我們處於優勢地位。非常重要的是，我們現在要花點時間，甚至在幾個月內放慢速度以更好地加速。這是一段漫長的旅程。因此，如果我們能找到一個既能帶來資源又能帶來能力的合作夥伴，我認為這方面的放緩將很快被遺忘。所以對我們來說更重要的是，這個時候，真的是找到了理想的合作夥伴。而且我認為該時間線會在整個過程中照顧好自己。

Thank you, Paul. Another question here. If we don't find a partner, would we decide to proceed on our own or just give up on it?

謝謝你，保羅。這裡還有一個問題。如果我們找不到合作夥伴，我們會決定自己繼續還是乾脆放棄？

Well, we're certainly not going to give up. We have a protocol that we worked absolutely hard to get to where it is now and that can actually make us enter the market first, second or third and be extremely relevant in an area of unmet medical need. So we're just, as I said, at this time, it's premature to actually go over and speculate over what would happen. But the partnership is on the table at this time.

好吧，我們當然不會放棄。我們有一個協議，我們非常努力地工作以達到現在的水平，它實際上可以讓我們首先、第二或第三進入市場，並且在未滿足的醫療需求領域非常相關。所以我們只是，正如我所說，在這個時候，真正過去並推測會發生什麼還為時過早。但此時合作夥伴關係已擺在桌面上。

We've got an advisory company that is helping out. The process has started, the outreach is on. And we'll actually meet these organizations, unveil the data, get them to see what we have seen, get them to actually interact with the advisers and KOLs that are supporting this. And I'm very confident that they're going to want to actually be part of it.

我們有一家諮詢公司正在提供幫助。該流程已經啟動，外展活動正在進行中。我們將與這些組織實際會面，公佈數據，讓他們看到我們所看到的，讓他們與支持這一點的顧問和 KOL 進行實際互動。而且我非常有信心他們會想要真正成為其中的一部分。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Now on the oncology platform. Given the time line presented during the last webcast, can it be assumed that we are in the therapeutic-dosage level of docetaxel?

現在在腫瘤學平台上。鑑於上次網絡廣播期間提供的時間線，是否可以假設我們處於多西紫杉醇的治療劑量水平？

Christian, do you want to provide an update?

克里斯蒂安，你想提供更新嗎？

Yes. Absolutely. I won't go into specifics of the trial. As you know, the -- we have to manage the study very confidentially to some extent and make sure that if we announce something that everything will be validated. But at the moment, the recruitment is going very well. We're recruiting patients and dose escalating at a rate of 3 to 4 weeks. We could do it every 3 weeks. But by the time that we recruit the following patient, ensuring that everything is done, and we have the appropriate data from the prior cycle, then it's going -- the increase is every 3 to 4 weeks.

是的。絕對地。我不會詳細介紹試驗的細節。如您所知，我們必須在某種程度上非常保密地管理研究，並確保如果我們宣布某些事情，一切都會得到驗證。但目前，招聘工作進展順利。我們正在招募患者並以 3 到 4 週的速度增加劑量。我們可以每 3 週進行一次。但是當我們招募以下患者時，確保一切都完成，並且我們從前一個週期獲得適當的數據，然後它就會開始 - 每 3 到 4 週增加一次。

And we started the first patient, as you know, on March 23. And the study is proceeding well. And we also now have increased the number of sites. We started with per site of Dr. (inaudible) MD Anderson has been open for a few weeks, and we now have opened 2 additional sites for recruitment.

如您所知，我們在 3 月 23 日開始了第一位患者。研究進展順利。我們現在也增加了站點的數量。我們從 MD Anderson 博士（聽不清）的每個網站開始，已經開放了幾週，現在我們又開設了 2 個招聘網站。

Thank you, Christian. We have another question regarding the oncology platform, regarding the number of patients that have been dosed so far and if all 4 centers have enrolled patients.

謝謝你，克里斯蒂安。我們還有一個關於腫瘤學平台的問題，關於到目前為止已經給藥的患者數量以及是否所有 4 個中心都已招募患者。

At the moment, all 4 centers are active and screening patients. At the moment, we have 2 sites that recruited patients. But in the coming months, the other sites will also add patients to this program.

目前，所有 4 個中心都在積極篩查患者。目前，我們有 2 個招募患者的站點。但在接下來的幾個月裡，其他站點也將向該項目添加患者。

Thank you very much. Regarding our HIV business, with the focus increasingly on oncology, what's to think of the HIV business?

非常感謝。關於我們的 HIV 業務，隨著人們越來越關注腫瘤學，如何看待 HIV 業務？

Well, the HIV business is that we've got a commercial lane to our business, and we're generating revenue. So we shouldn't be ashamed of generating revenue. It's a good thing. And what is more important to me is even the fact that we are building capabilities for the future. We have an organization in Europe. We have an organization in the U.S. We're calling on doctors. We've got MSLs on the ground. We're doing what mid-sized, large-sized pharma are doing, and that's going to be handy in the future, especially as the NASH program is going to unfold, I think there is going to be a long prelaunch phase associated to that, having people on the ground, capabilities, having people who know inside out. What (inaudible) all about will be a great asset for ourselves and also for our potential partner. So the HIV business for now is important and it's generating revenues, and it allows us to build capabilities for the future.

好吧，艾滋病毒業務是我們的業務有一條商業渠道，我們正在創造收入。所以我們不應該以創造收入為恥。這是一件好事。對我來說更重要的是，我們正在為未來建設能力。我們在歐洲有一個組織。我們在美國有一個組織，我們正在呼籲醫生。我們在地面上有 MSL。我們正在做中型、大型製藥公司正在做的事情，這在未來會很方便，尤其是隨著 NASH 計劃的展開，我認為這將是一個漫長的啟動前階段，有實地人員，有能力，有內在的人。這一切（聽不清）對我們自己和我們的潛在合作夥伴來說都是一筆巨大的財富。因此，目前的 HIV 業務很重要，它正在產生收入，它使我們能夠為未來建立能力。

Thank you. Going back to the oncology platform. In terms of efficacy, are there any expectations coming out of our Phase I?

謝謝。回到腫瘤學平台。在療效方面，我們的第一階段是否有任何期望？

Christian?

基督教？

Yes. Maybe let me start with the objective of this Phase I trial, which is really to determine what will be the maximum rate of dose of the drug, which will be the dose that will be used in the Phase II. However, as you know, that study is done in cancer patients that are advanced and that are resistance to prior treatment. And it is possible that we observe some efficacy. And this is why we think based on the number of cycle and the length of time it takes to confirm if there's a response because if we see an impact on the tumor shrinkage, we still need to wait for 3 months before we can confirm the response that we would be in a position to evoke some information in the fourth quarter of 2021.

是的。也許讓我從第一階段試驗的目標開始，這實際上是確定藥物的最大劑量率是多少，這將是第二階段使用的劑量。然而，如您所知，該研究是在晚期癌症患者中進行的，這些患者對先前的治療有抵抗力。我們有可能觀察到一些功效。這就是為什麼我們根據周期數和確認是否有反應所需的時間長度來考慮，因為如果我們看到對腫瘤縮小的影響，我們仍然需要等待 3 個月才能確認反應我們將能夠在 2021 年第四季度喚起一些信息。

That's great. Thank you, Christian. One additional question. In terms of safety, is there -- do we expect to see neutropenia at scheduled doses?

那太棒了。謝謝你，克里斯蒂安。一個額外的問題。就安全性而言，我們是否希望在預定劑量下看到中性粒細胞減少症？

Once again, this is the same thing. It's -- I cannot talk about the results or the doses for us exactly at the moment. However, based on the animal data that we have seen, and based on the (inaudible) program that we have conducted, we certainly do think that we won't see neutropenia at equimolar concentration of docetaxel that we will be able to dose escalate higher than the dose of docetaxel presently used to treat cancer patients. And once again, we think that this data will firm up, and we'll probably be able to announce something in the fourth quarter of 2021.

再一次，這是同一件事。這是——我現在不能準確地談論我們的結果或劑量。然而，根據我們看到的動物數據，以及我們進行的（聽不清）項目，我們確實認為在等摩爾濃度的多西紫杉醇下我們不會看到中性粒細胞減少症，我們將能夠增加劑量比目前用於治療癌症患者的多西紫杉醇的劑量。再一次，我們認為這些數據將會穩固，我們可能會在 2021 年第四季度宣布一些事情。

Wonderful. Thank you, Christian. (Operator Instructions) And I will give a few seconds for additional questions to come in.

精彩的。謝謝你，克里斯蒂安。（操作員說明）我會花幾秒鐘時間讓其他問題進來。

There doesn't seem to be more questions coming in this morning. So at this time, we will conclude this morning's earnings conference call.

今天早上似乎沒有更多的問題了。所以在這個時候，我們將結束今天上午的收益電話會議。

I would like to thank everyone for being on the call this morning. And on behalf of everyone here at Theratechnologies, I wish you a very pleasant day. Thank you.

我要感謝大家今天早上的電話會議。我代表 Theratechnologies 的每一個人，祝你們度過愉快的一天。謝謝。

Well, ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.

女士們先生們，今天的演講到此結束。您現在可以斷開連接，並度過美好的一天。