Theratechnologies Inc (THTX) 2021 Q1 法說會逐字稿

Welcome to the Theratechnologies Conference Call.

歡迎參加 Theratechnologies 電話會議。

(Operator Instructions)

（操作員說明）

I would like to remind everyone that this conference call is being recorded today, April 14, at 8:30 a.m. Eastern Time. And I would like to now turn the conference over to Denis Boucher, Vice President, Communications and Corporate Affairs. Mr. Boucher, please go ahead.

我想提醒大家，本次電話會議是在東部時間今天 4 月 14 日上午 8 點 30 分錄製的。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, and welcome Mr. Paul Levesque, 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 open exclusively to financial analysts will follow their presentation. Before Paul begins his remarks, I've been asked by Theratechnologies to read the following message regarding 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. 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.

謝謝，並歡迎 Theratechnologies 總裁兼首席執行官 Paul Levesque 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。在他們的演講之後，將有一個專門向金融分析師開放的問答環節。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。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。

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

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 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 上查閱。

Forward-looking statements represent Theratechnologies' expectations as of April 14, 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 4 月 14 日的預期，證券法可能要求的除外。 Theratechnologies 不承擔任何更新任何前瞻性聲明的義務，無論是作為新信息的結果。未來事件或其他。

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. I would like to begin today reflecting the last 12 months and also give thanks to what Theratechnologies team has accomplishing this time, helping to position us for growth in the medium and long term.

謝謝你，丹尼斯。大家早上好，感謝你們今天和我們在一起。我想從今天開始回顧過去 12 個月，並感謝 Theratechnologies 團隊這次取得的成就，幫助我們為中長期增長做好準備。

Coincidentally, I have been with Theratechnologies for 1 year now and in my time here as CEO, we've made strong headways toward unlocking the additional potential of the company's commercial and pipeline businesses. I am confident in the strategic plan that we have mapped out and believe that Theratechnologies is at a unique point in its evolution. We have a tremendous opportunity ahead of us to further strengthen our business.

巧合的是，我已經在 Theratechnologies 工作了一年，在我擔任首席執行官期間，我們在釋放公司商業和管道業務的額外潛力方面取得了長足的進步。我對我們制定的戰略計劃充滿信心，並相信 Theratechnologies 正處於其發展的獨特階段。我們面前有一個巨大的機會來進一步加強我們的業務。

Nonetheless, while setting our road map in motion over the course of the year, pandemic was also taking hold of the world on a global scale and placing additional and unforeseen challenges in front of us. As a result of the pandemic, global economies, businesses of all sizes and sectors, families and individuals were thrusted into operating in a completely different way, and we were certainly not immune to this. But we're now aligned with the company's mission and values more than ever, which is to bring new treatment options to healthcare providers and patients by developing and commercializing innovative therapies in areas of high unmet need.

儘管如此，在製定我們的路線圖的同時，大流行病也在全球範圍內席捲全球，並給我們帶來了更多無法預料的挑戰。由於大流行，全球經濟、各種規模和行業的企業、家庭和個人被迫以完全不同的方式經營，我們當然也不能倖免。但我們現在比以往任何時候都更符合公司的使命和價值觀，即通過在高度未滿足的需求領域開發和商業化創新療法，為醫療保健提供者和患者帶來新的治療選擇。

For people living with HIV, this was even more poignant in 2020 as a result of the pandemic. I am very humbled by what we have achieved. We exited 2020 as a stronger, more focus and aligned organization and have continued that momentum into the start of 2021. Even though our business has been challenged by the pandemic, we continue to move forward based on the execution of our strategic road map engrained with the commitment to our external stakeholders and the patients and communities that we serve. As a result, I believe we have reached an inflection point underpinned by our strategic investment in and attention placed on 2 critical objectives: advancing our clinical development pipeline programs in NASH and oncology and growing our HIV commercial franchise.

對於艾滋病毒感染者來說，由於大流行，這在 2020 年更加令人痛苦。我對我們所取得的成就感到非常謙卑。我們作為一個更強大、更專注和更一致的組織退出了 2020 年，並將這種勢頭延續到 2021 年初。儘管我們的業務受到了大流行的挑戰，但我們在執行我們根深蒂固的戰略路線圖的基礎上繼續前進對我們的外部利益相關者以及我們服務的患者和社區的承諾。因此，我相信我們已經達到了一個轉折點，這得益於我們對兩個關鍵目標的戰略投資和關注：推進我們在 NASH 和腫瘤學方面的臨床開發管道計劃，以及擴大我們的 HIV 商業特許經營權。

With regards to our clinical pipeline in oncology, we are extremely pleased that our Phase I clinical trial is elevating our lead peptide-drug conjugate, TH1902, for the treatment of sortilin positive solid tumors commenced last month ahead of our targeted time frame. In just a few months, we have moved TH1902 through the regulatory initiation process, identified and onboarded clinical sites and completed screenings and dosed our first patient in March.

關於我們在腫瘤學方面的臨床管道，我們非常高興我們的 I 期臨床試驗正在提升我們的先導肽-藥物偶聯物 TH1902，用於治療上個月比我們的目標時間框架提前開始的分揀蛋白陽性實體瘤。在短短幾個月內，我們已經將 TH1902 推進了監管啟動程序，確定並啟動了臨床站點，並完成了篩查，並在 3 月份為我們的第一位患者給藥。

We received Fast Track designation from the FDA for TH1902 in February of this year, which was a remarkable accomplishment. To date, very few companies have been granted Fast Track designation based on preclinical research, and we are excited and feel fortunate to be able to advance our oncology pipeline so swiftly. Through our SORT1+ technology, we believe that we have developed TH1902 as a fit-for-purpose peptide-drug conjugate that could potentially change the way cancer is treated.

今年 2 月，我們獲得了 FDA 對 TH1902 的快速通道指定，這是一項了不起的成就。迄今為止，很少有公司根據臨床前研究獲得快速通道指定，我們很高興也很幸運能夠如此迅速地推進我們的腫瘤管道。通過我們的 SORT1+ 技術，我們相信我們已經開發出 TH1902 作為一種適合用途的肽藥物偶聯物，可能會改變癌症的治療方式。

Just a few days ago, new positive preclinical data on TH1902 were presented at the American Association for Cancer Research annual meeting. These data demonstrated sustained tumor regression, better antitumor activity and tolerability with TH1902 compared to docetaxel alone in all cancer types studied. namely melanoma, pancreatic, ovarian, endometrial, colorectal and triple-negative breast cancers.

就在幾天前，美國癌症研究協會年會上公佈了 TH1902 新的陽性臨床前數據。這些數據表明，在所研究的所有癌症類型中，與單用多西紫杉醇相比，TH1902 具有持續的腫瘤消退、更好的抗腫瘤活性和耐受性。即黑色素瘤、胰腺癌、卵巢癌、子宮內膜癌、結直腸癌和三陰性乳腺癌。

The antitumor effect of TH1902 also persisted longer post treatment than with docetaxel alone. For TH1902 to demonstrate the positive tumor response in colorectal cancer was particularly remarkable, as this is a known hard to treat cancer that normally does not respond to docetaxel, the psychotoxic used with our SORT1+ technology to build TH1902. Furthermore, these data showed that in all cancer study, neutropenia was absent after 6 consecutive treatments with TH1902 at an equivalent dose of the maximum tolerated dose of docetaxel.

與單獨使用多西紫杉醇相比，TH1902 的抗腫瘤作用在治療後持續時間更長。 TH1902 在結直腸癌中表現出陽性腫瘤反應尤為引人注目，因為這是一種眾所周知的難以治療的癌症，通常對多西紫杉醇沒有反應，多西紫杉醇是與我們的 SORT1+ 技術一起用於構建 TH1902 的精神毒性物質。此外，這些數據表明，在所有癌症研究中，連續 6 次用 TH1902 治療（劑量與多西紫杉醇的最大耐受劑量相當）後，未出現中性粒細胞減少症。

We believe this is a major advantage of our SORT1+ technology. As many current cancers are known to cause neutropenia, even the most recent ADCs which increases a patient's susceptibility to develop infections and forces them to stop their cancer treatment to avoid this potentially severe side effect. These new data presented at AACR further support the development of TH1902 in various cancers as well as highlight its broad applicability for the potential treatment of all sorted and expressing solid tumors that are unresponsive to standard therapy.

我們相信這是我們 SORT1+ 技術的主要優勢。由於已知許多當前的癌症會導致中性粒細胞減少症，即使是最近的 ADC 也會增加患者發生感染的易感性並迫使他們停止癌症治療以避免這種潛在的嚴重副作用。在 AACR 上展示的這些新數據進一步支持了 TH1902 在各種癌症中的發展，並強調了其在潛在治療所有對標準療法無反應的分选和表達實體瘤方面的廣泛適用性。

We have contracted with a well-recognized global CRO to assist with our Phase I clinical trial and plan to collaborate with some of the most influential clinical center sites in the U.S., including Anderson Cancer Center in Houston, Texas, Gettysburg Cancer Center in Pennsylvania, Cedars-Sinai Medical Center in L.A. and Karmanos Center Institute in Detroit, Michigan, to name a few. We are excited for the opportunity to bring this innovative method of treatment to patients and look forward to providing you with additional updates.

我們已與一家知名的全球 CRO 簽約，協助我們進行 I 期臨床試驗，併計劃與美國一些最具影響力的臨床中心合作，包括德克薩斯州休斯頓的安德森癌症中心、賓夕法尼亞州的葛底斯堡癌症中心、洛杉磯的 Cedars-Sinai 醫療中心和密歇根州底特律的 Karmanos 中心研究所，僅舉幾例。我們很高興有機會為患者帶來這種創新的治療方法，並期待為您提供更多更新。

In NASH, Theratechnologies also has the potential to provide an opportunity to bring an innovative treatment in an area of high unmet need. The initiation of our Phase III clinical trial of tesamorelin for the treatment of NASH in Stage 2 or 3 fibrosis is on track to begin in the third quarter of the calendar year. Per the FDA's recommendation, we have confirmed a day to meet with the agency and discuss the proposed trial design and protocol.

在 NASH 中， Theratechnologies 也有可能提供一個機會，在一個高度未滿足的需求領域帶來創新治療。我們用於治療 2 期或 3 期纖維化 NASH 的 tesamorelin III 期臨床試驗有望在日曆年的第三季度開始。根據 FDA 的建議，我們已經確定了一天與該機構會面並討論擬議的試驗設計和方案。

To prepare for the start of this trial, our Chief Medical Officer, Dr. Christian Marsolais and his team have worked diligently to engage with key hepatologists in the NASH space in North America to actively build support for our Phase III program evaluating tesamorelin in NASH. We're using the same strategy in Europe to indicate KOLs ahead of the trial and aligned with the regulatory agencies.

為了準備開始這項試驗，我們的首席醫療官 Christian Marsolais 博士和他的團隊努力工作，與北美 NASH 領域的主要肝病學家合作，積極為我們在 NASH 中評估替沙莫林的 III 期項目提供支持。我們在歐洲使用相同的策略在試驗前指示 KOL，並與監管機構保持一致。

Given the well-established clinical history and unique mode of action of tesamorelin, which is designed to work upstream to reduce the accumulation of liver fat that feeds the NASH. The feedback we have received from pre-KOL has been very positive. We have contracted with a global large-scale CRO that will assist in working with key centers to execute the trial. Based on the insight that we have received from the FDA thus far, including a study we proceeded later in January of this year and the support and feedback we've received from the global experts in hepatic diseases in NASH, we are fully confident in our ability to initiate the Phase III trial on time.

鑑於 tesamorelin 的良好臨床歷史和獨特的作用模式，它旨在上游工作以減少為 NASH 提供食物的肝臟脂肪的積累。我們從 pre-KOL 那裡收到的反饋非常積極。我們已與一家全球大型 CRO 簽約，該 CRO 將協助與關鍵中心合作執行試驗。根據我們迄今為止從 FDA 獲得的見解，包括我們在今年 1 月晚些時候進行的一項研究，以及我們從全球 NASH 肝病專家那裡獲得的支持和反饋，我們對我們的產品充滿信心能夠按時啟動 III 期試驗。

It is also important to highlight that we are in a unique and very favorable position entering Phase III development with a treatment that has a support of 10 years of safety data in a predetermined dose at the start of the trial. Combined with an intellectual property position that has been further strengthened by a newly issued patent for the treatment of liver disease, tesamorelin has the potential to become a best-in-class candidate for the treatment of the serious and deadly condition.

同樣重要的是要強調，我們處於進入 III 期開發的獨特且非常有利的位置，該治療在試驗開始時以預定劑量得到 10 年安全數據的支持。結合新發布的肝病治療專利進一步加強的知識產權地位，tesamorelin 有可能成為治療嚴重和致命疾病的一流候選藥物。

We plan to use the FA formulation of tesamorelin in our Phase III NASH trial. The FA formulation has a number of significant improvements over our current F4 formulation, which is carefully commercialized as EGRIFTA SV for the treatment of HIV-associated lipodystrophy. Unlike the F4, the FA formulation is twice as concentrated, resulting in a smaller volume of administration and is intended to be presented in a multidose buyout that can be reconstituted once per week.

我們計劃在我們的 III 期 NASH 試驗中使用替沙莫林的 FA 製劑。 FA 配方比我們目前的 F4 配方有許多重大改進，F4 配方被小心地商業化為 EGRIFTA SV，用於治療 HIV 相關的脂肪代謝障礙。與 F4 不同的是，FA 製劑的濃度是 F4 的兩倍，因此給藥量更小，旨在以多劑量購買的形式出現，每周可以重新配製一次。

In addition to the FA formulation, we're also developing a multidose pen injector to be used with the FA, once approved, which is progressing as planned. We believe a multidose pen formulation of FA presents a number of significant advantages for not only our NASH program, but also for our current commercial opportunity in HIV-associated lipodystrophy as it has the potential to change that way physicians and patients look at the management of this fab. We will include the multi-dose pen injector and the FA formulation in the same DLA, which we intend to file with the FDA in early 2022 and believe both opportunities serve as an important management in the life cycle management of tesamorelin.

除了 FA 配方外，我們還在開發一種與 FA 一起使用的多劑量筆式註射器，一旦獲得批准，這將按計劃進行。我們相信 FA 的多劑量筆配方不僅為我們的 NASH 計劃，而且為我們目前在 HIV 相關脂肪營養不良方面的商業機會提供了許多顯著優勢，因為它有可能改變醫生和患者看待管理的方式這個工廠。我們將在同一 DLA 中包括多劑量筆式註射器和 FA 製劑，我們打算在 2022 年初向 FDA 提交文件，並相信這兩個機會將成為替沙莫林生命週期管理的重要管理。

We are executing a similar strategy with Trogarzo, which is currently approved for multidrug-resistant HIV-1. In conjunction with our agreement with TaiMed Biologics, we are evaluating 2 new methods of administration of Trogarzo as we build upon the life cycle management of this important therapy. A study is underway and waiting an IV push administration of Trogarzo, and the trial is expected to be completed in the third quarter of 2021. Theratechnologies and TaiMed are also planning to evaluate an intramuscular method of administration for Trogarzo. We are very excited about both trials and these new modes of administration have the potential to improve overall patient compliance and improve their sustained quality of might, further strengthening our commitment to bring a long-acting and efficacious therapeutic option for MDR HIV to patients and HAPs.

我們正在對 Trogarzo 執行類似的策略，Trogarzo 目前已被批准用於多重耐藥 HIV-1。結合我們與 TaiMed Biologics 的協議，我們正在評估 Trogarzo 的兩種新給藥方法，因為我們建立了這一重要療法的生命週期管理。一項研究正在進行中，等待 Trogarzo 的 IV 推動給藥，該試驗預計將於 2021 年第三季度完成。Theratechnologies 和 TaiMed 還計劃評估 Trogarzo 的肌肉內給藥方法。我們對這兩項試驗感到非常興奮，這些新的給藥方式有可能提高患者的整體依從性並提高他們的持續質量，進一步加強我們為患者和 HAP 提供長效有效的 MDR HIV 治療選擇的承諾.

We continue to seek opportunities to invest in the life cycle management of our HIV medicines, building upon our position in the niche HIV markets we serve in order to further support our patient communities. For Trogarzo, we have been focused on doctor and patient education as our independent research indicates a clear medical gap in regards to understanding the health management of a person with MDR HIV.

我們繼續尋求機會投資於我們的 HIV 藥物的生命週期管理，鞏固我們在我們所服務的利基 HIV 市場中的地位，以進一步支持我們的患者社區。對於 Trogarzo，我們一直專注於醫生和患者教育，因為我們的獨立研究表明，在理解 MDR HIV 患者的健康管理方面存在明顯的醫學差距。

In terms of unmet medical need and commercial importance, there is not a higher prior orientation population for us. Pandemic aside, the MDR HIV population poses a significant health concern. As for many of these patients, there are no other treatment options left. Additionally, we know from independent market research that the fair majority of these patients and doctors have a high intent to pursue new therapies once their current treatment stops working.

就未滿足的醫療需求和商業重要性而言，我們沒有更高的優先定位人群。除了大流行之外，耐多藥艾滋病病毒感染者構成了一個重大的健康問題。對於這些患者中的許多人來說，已經沒有其他治療選擇了。此外，我們從獨立的市場研究中了解到，一旦目前的治療無效，這些患者和醫生中的絕大多數都非常願意尋求新療法。

In the U.S., our marketing and community liaison team have been working to provide resources to patients based on real-world evidence and data, that they can be more empowered and indicated on their disease. Additionally, our teams have conducted patient case studies that provide important insights into the profile of MDR HIV patients and can be used as a helpful resource for HEP to identify patients and increase MDR HIV disease awareness.

在美國，我們的營銷和社區聯絡團隊一直致力於根據真實世界的證據和數據為患者提供資源，使他們能夠更有能力了解自己的疾病。此外，我們的團隊還進行了患者案例研究，這些研究提供了對 MDR HIV 患者概況的重要見解，並可用作 HEP 識別患者和提高 MDR HIV 疾病意識的有用資源。

To further our efforts, during the first quarter, we conducted a field study to better understand the patient experience while being treated with Trogarzo. This study focused on understanding patient access, advocacy in support as well as their satisfaction with dosing, administration and overall treatment. The feedback we received was extraordinary in gratifying with the majority of patients expressing a very high satisfaction rate of more than 90% across virtually all aspects of treatment, while 93% of patients indicated that they would recommend Trogarzo to other people living with HIV.

為了進一步努力，在第一季度，我們進行了一項實地研究，以更好地了解接受 Trogarzo 治療的患者體驗。這項研究的重點是了解患者的可及性、支持倡導以及他們對劑量、給藥和整體治療的滿意度。我們收到的反饋非常令人滿意，大多數患者對治療的幾乎所有方面都表示非常高的滿意度，超過 90%，而 93% 的患者表示他們會向其他 HIV 感染者推薦 Trogarzo。

Of particular note, patients express feeling more protected from their disease and optimistic that they have found a treatment that can offer a potentially long-term sustained effect, especially related to the reduction of their viral and improvements in their CD4 counts. We've taken a similar approach with doctors conducting outreach to better understand their experience with Trogarzo and created resources and data-driven guidelines to inform them on how to advance the care of their patients living with MDR HIV.

特別值得注意的是，患者表示感覺更能免受疾病侵害，並樂觀地認為他們已經找到了一種可以提供潛在長期持續效果的治療方法，特別是與減少病毒和改善 CD4 計數有關。我們採取了類似的方法與醫生進行外展，以更好地了解他們使用 Trogarzo 的經驗，並創建了資源和數據驅動的指南，以告知他們如何推進對 MDR HIV 患者的護理。

In Europe, our team has been working hard to make headways with KOLs to better inform them of the benefits of Trogarzo through advisory meetings and science-based virtual events in addition to building a base of newly identified patients. We continue to work towards obtaining 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 lifted.

在歐洲，我們的團隊一直在努力與 KOL 取得進展，以通過諮詢會議和基於科學的虛擬活動更好地告知他們 Trogarzo 的好處，此外還建立了新發現患者的基礎。我們繼續努力爭取在主要歐洲國家獲得 Trogarzo 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解除。

For EGRIFTA SV, we continue to educate doctors and patients that visceral fat is a serious metabolic condition and is more serious in the lifetime disease. In HIV patients, better understanding the consequences of visceral fat they are more likely to explore treatment options with their condition. We recognize that patient activation and profiling is key to bringing more patients on our therapy. To that end, we have launched a digital strategy that provides tools to allow both HCPs and patients to have more meaningful conversations about treatment options for this serious medical condition.

對於EGRIFTA SV，我們繼續教育醫生和患者，內臟脂肪是一種嚴重的代謝病症，在終生疾病中更為嚴重。在 HIV 患者中，更好地了解內臟脂肪的後果，他們更有可能根據自己的情況探索治療方案。我們認識到患者激活和分析是讓更多患者接受我們治療的關鍵。為此，我們推出了一項數字戰略，該戰略提供了一些工具，使 HCP 和患者能夠就這種嚴重疾病的治療方案進行更有意義的對話。

For example, we recently launched a new and enhanced website with EGRIFTA SV that provides tools and resources for HIV patients to help them identify their condition and also connect them with specialists that can help them overcome the burden of visceral fat. But a key barrier still remains, with the COVID-19 pandemic limiting resources in hospitals and clinics, doctors continue to be overwhelmed by treating COVID patients. In many cases, infectious disease, doctors and HCPs have been transferred to serve on the front line to fight against COVID, further impeding patients' ability to start treatment with 1 of our HIV medicines.

例如，我們最近推出了一個帶有 EGRIFTA SV 的全新增強型網站，該網站為 HIV 患者提供工具和資源，幫助他們確定自己的病情，並將他們與專家聯繫起來，幫助他們克服內臟脂肪的負擔。但一個關鍵障礙仍然存在，由於 COVID-19 大流行限制了醫院和診所的資源，醫生繼續因治療 COVID 患者而不知所措。在許多情況下，傳染病、醫生和 HCP 已被轉移到抗擊 COVID 的前線服務，這進一步阻礙了患者開始使用我們的一種 HIV 藥物進行治療的能力。

While first quarter sales were relatively flat year-over-year. We believe that the trends with the HIV medicines are moving in the right direction. This can be attributed to the momentum that our commercial and medical teams have built to create a stronger base of patients and physician support. Over the last 12 months, the prescriber base for both Trogarzo and EGRIFTA SV has more than doubled, which I believe is an indication that we are well positioned for commercial growth, particularly as we emerge from the pandemic. The fact that our business did not suffer more than it did is a testament to our team adjusting there rapidly to the necessary changes that were made during the pandemic. These strategic and marketing initiatives and commercial changes have now been laid out according to plan. Through these continued efforts, we now have a solid global commercial base that will provide an optimal landscape to grow our HIV medicines.

而第一季度的銷售額同比相對持平。我們相信 HIV 藥物的趨勢正在朝著正確的方向發展。這可以歸因於我們的商業和醫療團隊為建立更強大的患者和醫生支持基礎而建立的勢頭。在過去的 12 個月裡，Trogarzo 和 EGRIFTA SV 的處方藥基數增加了一倍多，我認為這表明我們為商業增長做好了充分準備，尤其是在我們從大流行中走出來的時候。事實上，我們的業務並沒有遭受比過去更大的損失，這證明我們的團隊正在迅速調整，以適應大流行期間所做的必要改變。這些戰略和營銷舉措以及商業變革現已按計劃進行。通過這些持續的努力，我們現在擁有堅實的全球商業基礎，將為我們的 HIV 藥物的發展提供最佳環境。

Let's now turn to Philippe for the first quarter results. Philippe, please go ahead.

現在讓我們來看看 Philippe 的第一季度業績。菲利普，請繼續。

Thanks, Paul, and good morning, everyone. Consolidated revenues for the first quarter of fiscal 2021 were $15.4 million, essentially flat over Q1 of 2020, and what is usually our most difficult quarter of the year, mostly because of public and private insurance factors in the United States.

謝謝，保羅，大家早上好。 2021 財年第一季度的綜合收入為 1540 萬美元，與 2020 年第一季度基本持平，這通常是我們一年中最困難的一個季度，主要是因為美國的公共和私人保險因素。

Revenues from EGRIFTA SV were $8.7 million, up 2% from the same period last year. While unit sales compared to Q1 2020 were essentially flat, inventory levels at our distributor at the end of the quarter were somewhat lower and this was compensated by higher selling price.

EGRIFTA SV 的收入為 870 萬美元，比去年同期增長 2%。雖然單位銷售額與 2020 年第一季度相比基本持平，但本季度末我們經銷商的庫存水平有所降低，這被更高的售價所彌補。

Trogarzo revenues were down 6% year-over-year as a result of lower unit sales to specialty pharmacies compounded by lower inventory levels at the distributor level. Although patient retention continues to be quite strong for Trogarzo, new patient starts remain below where we think they should be. As the U.S. emerges from COVID-related lockdowns, we are confident this situation will be resolved.

Trogarzo 的收入同比下降了 6%，這是由於對專業藥店的單位銷售額下降，加上分銷商層面的庫存水平下降。儘管 Trogarzo 的患者保留率仍然很高，但新患者開始人數仍低於我們認為應該的水平。隨著美國擺脫與 COVID 相關的封鎖，我們相信這種情況將會得到解決。

In the EU, we are seeing evidence that sales trends are moving on. But it's still early days yet to see a major impact from our sales and marketing efforts. Additionally, COVID in the EU is still problematic and is affecting patients' initiation of therapy. Our team in Europe is identifying patients, and we are confident that once restrictions related to COVID-19 are eased, we will see a meaningful flow of patients initiating therapy. Pricing discussions are progressing in the EU and reception has been positive.

在歐盟，我們看到有證據表明銷售趨勢正在向前發展。但要看到我們的銷售和營銷工作產生重大影響還為時過早。此外，歐盟的 COVID 仍然存在問題，並且正在影響患者開始治療。我們在歐洲的團隊正在識別患者，我們相信一旦放寬與 COVID-19 相關的限制，我們將看到大量患者開始接受治療。定價討論在歐盟取得進展，反響良好。

With this in mind, we have laid the groundwork to growing revenues of the Theratechnologies franchise, both in the U.S. and the EU and expect to see our efforts bear fruit from these strategic initiatives.

考慮到這一點，我們已經為 Theratechnologies 特許經營權在美國和歐盟的收入增長奠定了基礎，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 Q1 2021 was down to $5.4 million compared to $6.8 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 sales milestone in Q3 of last year.

2021 年第一季度的銷售成本降至 540 萬美元，而去年同期為 680 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銷售里程碑。

R&D expenses amounted to $4.9 million in Q1 '21 compared to $3.4 million for the same quarter last year. This increase is largely due to higher spending in our oncology and NASH programs, increased spending in medical and patient education as well as higher medical affairs initiatives in Europe.

21 年第一季度的研發費用為 490 萬美元，而去年同期為 340 萬美元。這一增長主要是由於我們的腫瘤學和 NASH 項目支出增加、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 February 28, 2021, selling expenses were down to $6.1 million compared to $6.3 million for the same period last year. The decrease is mostly associated with the transfer of resources from marketing to medical education activities. General and administrative expenses amounted to $3.6 million in Q1, up from $2.6 million in Q1 of 2020. This increase is mainly attributable to the overall increase in business activities as well as increased activity in Europe.

在截至 2021 年 2 月 28 日的三個月期間，銷售費用下降至 610 萬美元，而去年同期為 630 萬美元。減少主要與資源從市場營銷轉移到醫學教育活動有關。第一季度的一般和行政費用為 360 萬美元，高於 2020 年第一季度的 260 萬美元。這一增長主要歸因於業務活動的總體增長以及歐洲活動的增加。

In Q1 2021, we recorded $1.4 million of finance costs compared to $1.3 million in Q1 2020. As previously stated, finance costs comprised of interest on the convertible notes as well as accretion expense. For the first quarter of 2021, we recorded a negative EBITDA of $1.8 million compared to negative $1 million in Q1 2020. The difference is mainly due to a higher net loss during the quarter. Reflecting the impact of the capital raised during Q1 '21, we ended the first quarter with a cash and equivalent sum of $57 million.

2021 年第一季度，我們記錄了 140 萬美元的財務成本，而 2020 年第一季度為 130 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 年第一季度，我們錄得 180 萬美元的負 EBITDA，而 2020 年第一季度為負 100 萬美元。差異主要是由於本季度淨虧損增加。反映了 21 年第一季度募集資金的影響，我們在第一季度結束時獲得了 5700 萬美元的現金和等價物。

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. As we proceed to build momentum in 2021 and beyond. I can't stress enough the Theratechnologies of today is far from where we were in the past, and we're well positioned for future growth.

謝謝你，菲利普。隨著我們在 2021 年及以後建立勢頭。我怎麼強調都不為過，今天的 Theratechnologies 與我們過去的水平相差甚遠，而且我們已為未來的增長做好準備。

In line with our growth efforts is our continued progress to strengthen our business with talent that have a proven track record of being innovative in successfully leading organizations and developing important medicines.

與我們的增長努力相一致的是，我們不斷取得進展，通過在成功領導組織和開發重要藥物方面具有創新記錄的人才來加強我們的業務。

This is particularly highlighted by our recent announcements of 2 new strategic additions to our team. I would like to take this opportunity to formally welcome and introduce John Leasure as Theratechnologies newly appointed Global Commercial Officer; and Peter Kowal as the company's Vice President of our U.S. HIV commercial operation. Both John and Peter bring important capabilities that are needed to bring Theratechnologies through our next stage of growth. Peter experience and leadership will be integral in enhancing our efforts to grow sales for our HIV business in the U.S., while John will lead our global efforts to build our capabilities to be more competitive in HIV and take on the global landscape for NASH and oncology.

我們最近宣布我們的團隊有 2 名新的戰略成員，這一點尤為突出。我想藉此機會正式歡迎並介紹 John Leasure 擔任 Theratechnologies 新任命的全球商務官； Peter Kowal 擔任公司美國 HIV 商業運營副總裁。 John 和 Peter 都帶來了使 Theratechnologies 進入下一發展階段所需的重要能力。 Peter 的經驗和領導能力將成為加強我們在美國增加 HIV 業務銷售額的努力不可或缺的一部分，而 John 將領導我們的全球努力，以建立我們在 HIV 領域更具競爭力的能力，並在 NASH 和腫瘤學領域佔據全球格局。

I am very pleased that we were able to attract such talented and experienced individuals with sales and marketing expertise across HIV, endocrinology and oncology, and I look forward to their contributions toward the growth of our commercial assets and the development of our pipeline. Additionally, we have added a newly created function from our commercial organization with the appointment of a head of Global Manufacturing, sourcing and pharmaceutical development to oversee our North American and European supply chain, procurement, logistics and pharmaceutical development operations.

我很高興我們能夠吸引如此才華橫溢、經驗豐富的個人，他們在 HIV、內分泌學和腫瘤學方面具有銷售和營銷專業知識，我期待他們為我們的商業資產增長和管道開發做出貢獻。此外，我們還從我們的商業組織中增加了一個新創建的職能，任命了全球製造、採購和藥物開發負責人來監督我們的北美和歐洲供應鏈、採購、物流和藥物開發業務。

On the capital markets side, the recent offering we closed in January has afforded us the resources to further support our strategy to enhance our commercial initiatives, R&D development and working capital needs. Additionally, we are devoting more resources to enhance our outreach to the investment community, and the deal has allowed us to cultivate new institutional investors who are focused on life sciences and support our strategy.

在資本市場方面，我們在 1 月份完成的近期發行為我們提供了資源，可以進一步支持我們加強商業計劃、研發開發和營運資金需求的戰略。此外，我們正在投入更多資源來加強我們與投資界的聯繫，這筆交易使我們能夠培養專注於生命科學並支持我們戰略的新機構投資者。

I am absolutely confident that Theratechnologies now has the resources, talent and infrastructure needed to succeed, and we are committed to doing so to drive future sustainable growth and value creation for all our stakeholders.

我絕對相信 Theratechnologies 現在擁有成功所需的資源、人才和基礎設施，我們致力於推動未來的可持續增長和所有利益相關者的價值創造。

Thank you for your time today. And with that, we will now open the call to take your questions.

謝謝你今天的時間。有了這個，我們現在將打開電話來回答你的問題。

(Operator Instructions)

（操作員說明）

I'm not showing any questions at this time.

我現在不顯示任何問題。

Thank you very much, operator. If there are no questions at this time, we will conclude this morning's investor conference call. Thank you very much for being with us this morning. Have a very good day. Bye-bye.

非常感謝你，接線員。如果此時沒有問題，我們將結束今天上午的投資者電話會議。非常感謝你今天早上和我們在一起。祝你有美好的一天。再見。

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。您現在可以斷開連接。