Theratechnologies Inc (THTX) 2021 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies Fourth Quarter and Annual Fiscal Year 2021 Earnings Call. (Operator Instructions)

早上好，女士們，先生們，感謝你們的支持。歡迎來到 Theratechnologies 2021 財年第四季度和年度收益電話會議。 （操作員說明）

I will now turn the call over to John Mullaly, LifeSci Advisors. Mr. Mullaly, Please go ahead.

我現在將把電話轉給 LifeSci Advisors 的 John Mullaly。穆拉利先生，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.

謝謝，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。

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, level 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.

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 discussion and analysis issued in this morning's -- issued this morning available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements represent Theratechnologies' expectations as of February 23, 2022. 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.

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 將當前和潛在投資者引向其在今天上午發布的管理討論和分析中的前瞻性信息部分——今天上午發佈在 www.sedar.com 的 SEDAR 和 www.sec.gov 的 EDGAR 上。前瞻性陳述代表 Theratechnologies 截至 2022 年 2 月 23 日的預期。除非證券法可能要求，否則 Theratechnologies 不承擔任何更新任何前瞻性陳述的義務，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。

Thanks, John, and good morning to everyone joining the call today. I wish you a warm welcome and to express our thanks for taking part in Theratechnologies' journey. This has been an incredible year of milestone achievements in addition to the progress made in support of our commercial franchises. We want to focus your attention today on 4 key updates, which we believe are the major drivers in propelling our success in the new year. The drivers include the build-out of our own commercial sales and medical teams, our full year 2021 results, particularly our second half performance versus that of the first half, updates for our lead oncology asset, TH1902, and the progress in our NASH program.

謝謝，約翰，早上好，今天加入電話會議的所有人。我熱烈歡迎您，並感謝您參與 Theratechnologies 的旅程。除了在支持我們的商業特許經營方面取得的進展外，今年是取得里程碑式成就的令人難以置信的一年。今天，我們希望將您的注意力集中在 4 個關鍵更新上，我們認為它們是推動我們在新的一年取得成功的主要驅動力。這些驅動因素包括我們自己的商業銷售和醫療團隊的建設、我們 2021 年全年的業績，尤其是我們下半年與上半年的業績對比、我們的主要腫瘤學資產 TH1902 的更新，以及我們 NASH 計劃的進展.

As we already draw near to the close of Q1 of our new fiscal year, we carry with us the full momentum of 4 successful quarters of progress. What stands out the most about Theratechnologies is just how differentiated we are in being an early-stage biotech as we possess both late- and early-stage assets. Moreover, in addition to our pipeline development, we're also a drug company with mature commercial brands and a strong strategy to grow our franchises for years to come. I am mentioning this now since we have recently announced the strengthening of our global commercial capabilities through the launch of an internal field force.

隨著我們已經接近新財政年度第一季度的結束，我們帶著 4 個成功季度取得進展的全部勢頭。 Theratechnologies 最引人注目的是我們作為早期生物技術公司的差異化程度，因為我們同時擁有後期和早期資產。此外，除了我們的管道開發外，我們還是一家擁有成熟商業品牌和未來幾年發展特許經營權的強大戰略的製藥公司。我現在提到這一點，因為我們最近宣布通過啟動內部現場部隊來加強我們的全球商業能力。

Our commercial business has reached critical mass, and we look forward to kick starting our new stage of growth with this initiative. At present, we are finalizing our employment offers to top performers of the current sales force who will be joining the company from our partner contract sales organization. This will be in addition to the hiring of new experienced sales representatives in order to create a truly competitive field force. We do believe this will ultimately lead to superior performance and faster growth from our commercial portfolio.

我們的商業業務已達到臨界質量，我們期待著通過這一舉措開啟我們新的增長階段。目前，我們正在敲定我們對當前銷售隊伍中表現最好的人的聘用機會，他們將從我們的合作夥伴合同銷售組織加入公司。除了僱用新的有經驗的銷售代表之外，這還將是為了打造一支真正具有競爭力的現場隊伍。我們確實相信，這最終將導致我們的商業產品組合實現卓越的性能和更快的增長。

In parallel to this push to better serve our patients and health care providers, we're also strengthening our medical affairs team. We fully expect the expansion of our disease awareness initiatives, [more] ramp-up knowledge of the therapeutic field we are invested in across the patient and provider landscape. For example, we expect our PROMISE trial in North America and Europe for Trogarzo and the VAMOS study for [HIV] will contribute to helping health care providers identify patients in the diseases that we treat in building real-world evidence for assets, we are reinforcing the value they provide to patients, encouraging them to start and stay on therapy.

在推動更好地為我們的患者和醫療保健提供者服務的同時，我們也在加強我們的醫療事務團隊。我們完全期待擴大我們的疾病意識計劃，[更多]增加我們在患者和提供者領域投資的治療領域的知識。例如，我們希望我們在北美和歐洲針對 Trogarzo 的 PROMISE 試驗和針對 [HIV] 的 VAMOS 研究將有助於幫助醫療保健提供者識別我們治療的疾病患者，從而建立真實世界的資產證據，我們正在加強他們為患者提供的價值，鼓勵他們開始並堅持治療。

We are optimistic for what lies ahead in the new year, coupled by a positive post-COVID momentum, especially now that face-to-face meetings have resumed across most states. In making the decision to transition from a contract field force model to one staff by Theratechnologies employees, we are confident that the hiring of our owned field, sales and medical affairs teams will significantly improve the important task of engagement with our customers. We believe that both recruitment and retention of top talent will also improve as we begin this new chapter of the company's corporate development.

我們對新的一年的前景感到樂觀，再加上 COVID 後的積極勢頭，尤其是現在大多數州已經恢復了面對面的會議。在決定由 Theratechnologies 員工從合同外勤人員模型過渡到一名員工時，我們相信，聘用我們自己的外勤、銷售和醫療事務團隊將顯著改善與客戶互動的重要任務。我們相信，隨著我們開啟公司企業發展的新篇章，頂尖人才的招聘和留用也將得到改善。

In summary on this topic, as our new sales and medical affairs colleagues are integrated into the fall, I would like to express how delighted we are to welcome these key members of our contract field force into the Theratechnologies family. While 2021 overall growth was 5.7%. The second half grew 10% compared to just 1% in the first half versus 2020. In addition, new patient enrollment across our franchises grew a blended 24% in the second half of the year as compared to the same year ago period. This is a very good sign that with post-COVID promotion, we are gaining traction in the marketplace. Growing revenues and the execution of our commercial strategy in the new year remains a high priority as we move swiftly to catch up with demand for Trogarzo [and cryptic] in patients with unmet needs.

總結一下這個話題，隨著我們新的銷售和醫療事務同事融入秋季，我想表達我們是多麼高興地歡迎我們合同外勤人員的這些主要成員加入 Theratechnologies 大家庭。而 2021 年的整體增長率為 5.7%。與 2020 年相比，下半年增長了 10%，而上半年僅增長了 1%。此外，與去年同期相比，下半年我們特許經營的新患者註冊人數混合增長了 24%。這是一個很好的跡象，表明通過後 COVID 促銷，我們在市場上獲得了吸引力。隨著我們迅速採取行動以滿足未滿足需求的患者對 Trogarzo [和神秘]的需求，在新的一年裡增加收入和執行我們的商業戰略仍然是重中之重。

As a side note, capital access is very difficult in the current volatile biotech market. However, revenues from our commercial business serves to support and derisk our pipeline development. This relative advantage of being a revenue-generating enterprise is that our commercial business allows us to be more selective in our capital allocation choices. On the clinical track, we're happy to report that our oncology program is close, very close to establishing the maximum tolerated dose or MTD and to initiating the Part B of the Phase I trial of TH1902. We are now in the final stages of TH1902's, Phase I Part A dose escalation study, evaluating our lead investigational peptide drug conjugate for the treatment of sortilin-positive cancers.

附帶說明一下，在當前動蕩的生物技術市場中，資本獲取非常困難。然而，我們商業業務的收入用於支持和降低我們管道開發的風險。作為創收企業的這種相對優勢在於，我們的商業業務使我們能夠在資本配置選擇上更具選擇性。在臨床軌道上，我們很高興地報告我們的腫瘤學計劃已經接近，非常接近確定最大耐受劑量或 MTD 並啟動 TH1902 I 期試驗的 B 部分。我們現在處於 TH1902 的 I 期 A 部分劑量遞增研究的最後階段，評估我們用於治療 sortilin 陽性癌症的主要研究肽藥物偶聯物。

In total, 4 patients in the trial have been administered significant doses of TH1902, at 420 milligrams per square meter, equivalent to nearly 2x the indicated therapeutic dose of docetaxel. To date, we have observed a dose-limiting toxicity, or DLT, in 1 patient, consisting of a grade 4 neutropenia lasting more than 7 days as well as other adverse events after more than 1 cycle at 420 milligrams per square meter. As a result, we have decided to pursue the study at the lower dose of 300 milligram per square meter or approximately 1.5x the usual dose of docetaxel. We currently are enrolling patients at this lower dose to confirm the absence of DLTs following the first cycle.

總共有 4 名參與試驗的患者接受了顯著劑量的 TH1902，劑量為每平方米 420 毫克，相當於多西紫杉醇指定治療劑量的近 2 倍。迄今為止，我們已經在 1 名患者中觀察到劑量限制性毒性或 DLT，包括持續超過 7 天的 4 級中性粒細胞減少症以及在 420 毫克/平方米的 1 個週期以上後的其他不良事件。因此，我們決定以每平方米 300 毫克或大約 1.5 倍多西紫杉醇常用劑量的較低劑量繼續研究。我們目前正在招募這種較低劑量的患者，以確認在第一個週期後沒有 DLT。

Once MTD has been established a study protocol allows for immediate initiation of enrollment of the larger open-label basket trial. The basket trial will further assess the safety and tolerability of TH1902. Additionally, the preliminary antitumor activity of TH1902 will be evaluated for all patients as per the responsive evaluation criteria in solid tumors. Based on additional research we have conducted on the SORT1 receptor, we have submitted an amendment to the Phase I protocol to the FDA to include the following solid tumor types. Hormone positive breast cancer, triple negative breast cancer, ovarian cancer, endometrial cancer and melanoma with approximately 10 patients per tumor type.

一旦建立了 MTD，研究方案允許立即開始更大的開放標籤籃子試驗的註冊。籃子試驗將進一步評估 TH1902 的安全性和耐受性。此外，TH1902的初步抗腫瘤活性將根據實體瘤的反應性評估標準對所有患者進行評估。基於我們對 SORT1 受體進行的額外研究，我們已向 FDA 提交了對 I 期方案的修正案，以包括以下實體瘤類型。激素陽性乳腺癌、三陰性乳腺癌、卵巢癌、子宮內膜癌和黑色素瘤，每種腫瘤類型約有 10 名患者。

In addition, one arm will be added to include a mix of tumor types, including thyroid, small cell lung, prostate and potential of the high sortilin expressing cancers with 15 patients in total. The original trial design consisted of 40 patients across a selection of solid tumors, including colorectal and pancreatic cancers. The plan now is to enroll a total of approximately 70 patients in the basket trial in order to evaluate the potential antitumor activity of TH1902. As previously mentioned, we're also exploring the possibility of out-licensing development and commercialization rights for TH1902, in Greater China. We are very pleased to report that there has been solid interest on the part of Chinese companies and that discussions are ongoing with a number of different pharmaceutical and biotech companies.

此外，將增加一個手臂以包括混合腫瘤類型，包括甲狀腺、小細胞肺癌、前列腺癌和潛在的高分選蛋白表達癌症，總共有 15 名患者。最初的試驗設計包括 40 名實體瘤患者，包括結直腸癌和胰腺癌。現在的計劃是在籃子試驗中招募大約 70 名患者，以評估 TH1902 的潛在抗腫瘤活性。如前所述，我們還在探索在大中華區外包 TH1902 開發和商業化權利的可能性。我們很高興地報告說，中國公司對此表現出了濃厚的興趣，並且正在與許多不同的製藥和生物技術公司進行討論。

In addition to the geographic exposure gain from these dialogues, we're also in exploratory talks with companies seeking to leverage our peptide as a carrier to target cancer cells through SORT1 receptors. Looking at the potential of TH1902's internal development, outlicensing and partnering opportunities, we are optimistic in our approach to managing the development of TH1902, for the treatment of solid metastatic and refractory cancers both in the near and medium term.

除了從這些對話中獲得地理曝光度外，我們還在與尋求利用我們的肽作為載體通過 SORT1 受體靶向癌細胞的公司進行探索性對話。考慮到 TH1902 的內部開發、外發許可和合作機會的潛力，我們對管理 TH1902 開發的方法持樂觀態度，用於在近期和中期治療實體轉移性和難治性癌症。

Moving on to our national update. You may have recently seen in the news that a company with interest in NASH published very interesting data. The investment community subsequently reacted very favorably. Based on this and other recent data published in the area of NAFL and NASH, we are seeing renewed interest and believe more than ever in the prospects for tesamorelin as the treatment for NASH as a treatment for NASH as experts continue to gain awareness of the tesamorelin as a NASH treatment option. While we continue to see partnering in non-diluted financing options, our Phase III NASH program, the company will submit in the upcoming days an amended protocol to establish an interim analysis of primary endpoints.

繼續我們的國家更新。你可能最近在新聞中看到，一家對 NASH 感興趣的公司發布了非常有趣的數據。投資界隨後反應非常好。基於這一數據和最近在 NAFL 和 NASH 領域發表的其他數據，我們看到了新的興趣，並且比以往任何時候都更加相信替沙莫林作為 NASH 治療的前景，因為專家們繼續獲得對替沙莫林的認識作為 NASH 的治療選擇。雖然我們繼續看到在非稀釋融資方案（我們的 III 期 NASH 計劃）方面的合作，但該公司將在未來幾天提交一份修訂後的協議，以建立對主要終點的中期分析。

The new trial design will include a seamless Phase IIb/III study, where the first 350 of the planned total 1,094 patients data will be analyzed by a data monitoring committee in order to assess the efficacy of tesamorelin on a smaller subset of patients. A decision will then be made to proceed with the study's remainder of the planned total 1,094 patients. While this doesn't change the total number of patients required to seek accelerated FDA approval of tesamorelin for the treatment of general NASH. It will serve as a substantial derisking event and will inform the continuation of enrollment while providing an indication of benefits to patients. In the meantime, we continue to seek an ideal partner with both the credibility and the capability to assist us with the NASH program going forward. And in covering our basis, we're also seeking financing alternatives to execute the trial up to the interim analysis on our own.

新的試驗設計將包括一項無縫的 IIb / III 期研究，其中計劃的總計 1,094 名患者數據中的前 350 名將由數據監測委員會進行分析，以評估 tesamorelin 對一小部分患者的療效。然後將決定繼續進行計劃中的 1,094 名患者中的其餘部分。雖然這不會改變尋求 FDA 加速批准替沙莫林用於治療一般 NASH 所需的患者總數。它將作為一個實質性的去風險事件，並將通知繼續登記，同時為患者提供益處的指示。與此同時，我們繼續尋找具有信譽和能力的理想合作夥伴，以協助我們推進 NASH 計劃。在覆蓋我們的基礎上，我們也在尋求融資替代方案來執行試驗，直到我們自己進行中期分析。

Before I turn the call over to Philippe, I want to note that our objectives for fiscal 2022 remain crystal clear. From a development perspective, we're also continuing our line extension efforts to further develop the benefits or convenience of our products, which includes new formulations and mode of administration. In total, our program management strategies to develop the complete portfolio of assets with clear, immediate, near-term, medium and long-term catalysts that will benefit not only patients' unmet needs, but provide entry and exit opportunities for investors at line.

在我將電話轉給 Philippe 之前，我想指出，我們 2022 財年的目標仍然非常明確。從發展的角度來看，我們還在繼續我們的產品線擴展工作，以進一步開發我們產品的好處或便利性，其中包括新的配方和管理方式。總的來說，我們的項目管理戰略旨在開發具有明確、即時、近期、中期和長期催化劑的完整資產組合，這不僅有利於患者未滿足的需求，而且為投資者提供進入和退出的機會。

With this, I would like to turn the call over to Philippe, who will provide a financial summary for the reporting period before moving to Q&A. Philippe?

有了這個，我想把電話轉給 Philippe，他將在進入問答環節之前提供報告期間的財務摘要。菲利普？

Thanks, Paul, and good morning, everyone. Consolidated revenues for the fourth quarter of our fiscal year 2021 were $18.8 million, down 1.9% versus Q4 of 2020. As I will explain later, our top line for the quarter was affected by a provision we are taking related to potential clawbacks in France and which are directly related to our ongoing negotiations with the government for the reimbursement of Trogarzo. We are, however, pleased to report that revenues of EGRIFTA SV were $12.7 million this quarter, up 18.6% from the same period of last year. Increased sales of EGRIFTA SV were the results of a higher unit sales and higher net selling price, mostly a result of a combination of our higher gross selling price and lower rebates and chargebacks from government payers in the U.S.

謝謝，保羅，大家早上好。我們 2021 財年第四季度的綜合收入為 1880 萬美元，比 2020 年第四季度下降 1.9%。正如我稍後將解釋的那樣，我們本季度的收入受到我們正在採取的與法國和這與我們正在進行的與政府就 Trogarzo 的報銷進行的談判直接相關。然而，我們很高興地報告，本季度 EGRIFTA SV 的收入為 1270 萬美元，比去年同期增長 18.6%。 EGRIFTA SV 銷售額的增加是單位銷售額增加和淨銷售價格增加的結果，這主要是由於我們較高的總銷售價格以及美國政府付款人的較低迴扣和退單相結合的結果。

Trogarzo revenues were $6 million during the quarter, down from $8.4 million in the same period of 2020. Unit sales were down 7% year-over-year and were mostly affected by lower new patient starts during the COVID-19 pandemic. We are currently seeing clinics reopen and face-to-face meeting with physicians increased as a result of the general reopening of the economy. We are confident that Trogarzo unit sales will start growing again in 2022, even if the recent short-term lockdowns related to the Omicron variant has affected the market in December to January.

Trogarzo 本季度的收入為 600 萬美元，低於 2020 年同期的 840 萬美元。單位銷售額同比下降 7%，主要受到 COVID-19大流行期間新患者開始減少的影響。由於經濟的全面重新開放，我們目前看到診所重新開放，與醫生的面對面會面有所增加。我們相信 Trogarzo 的銷量將在 2022 年再次開始增長，即使最近與 Omicron 變體相關的短期停工影響了 12 月至 1 月的市場。

The bigger impact to Trogarzo revenues was related to a provision we needed to take in anticipation of clawbacks related to early sales of Trogarzo in France. This provision is mostly related to the anticipated price to be negotiated with the French government, which is being affected by the agreed price of a competing drug. Negotiations with the French government continue, and we believe we will be able to conclude these negotiations shortly. As our first quarter will end in the next few days, I can report that Trogarzo unit sales have resumed growing after a difficult few quarters and that EGRIFTA SV unit sales have grown in the 20% range from Q1 2020 to Q1 2021.

對 Trogarzo 收入的更大影響與我們需要採取的一項準備金有關，以應對與 Trogarzo 在法國的早期銷售相關的回撥。這一規定主要與與法國政府談判的預期價格有關，該價格受到競爭藥物的約定價格的影響。與法國政府的談判仍在繼續，我們相信我們將能夠很快結束這些談判。由於我們的第一季度將在未來幾天結束，我可以報告說，Trogarzo 的單位銷售額在經歷了艱難的幾個季度後已經恢復增長，並且 EGRIFTA SV 的單位銷售額從 2020 年第一季度到 2021 年第一季度增長了 20%。

So with this in mind, we are announcing a revenue guidance for fiscal 2022 this morning and are expecting sales revenue of between 79 and $84 million. Cost of sales in Q4 2021 was relatively stable at $6.4 million compared to $6.7 million for the same quarter last year. The decrease is mostly due to production-related costs, which were incurred in 2020, but not in 2021. R&D expenses amounted to $8.7 million in Q4 compared to $6.8 million for the same quarter last year.

因此，考慮到這一點，我們今天上午宣布了 2022 財年的收入指引，預計銷售收入在 79 至 8400 萬美元之間。 2021 年第四季度的銷售成本相對穩定，為 640 萬美元，而去年同期為 670 萬美元。減少的主要原因是與生產相關的成本，這些成本發生在 2020 年，而不是在 2021 年。第四季度的研發費用為 870 萬美元，而去年同期為 680 萬美元。

This increase is largely due to higher spending in our oncology program, including the Phase I trial and the NASH Phase III preparations, increased spending in medical and patient education as well as higher medical affairs initiatives in Europe. For the 3-month period ended November 30, 2021, selling expenses have amounted to $8.2 million compared to $6.5 million in the same period last year. The increase in selling expenses is largely associated with the addition of senior personnel in North America to build a stronger sales organization as well as increased activities in Europe ahead of the launch of Trivarzo in key markets. G&A expenses amounted to $3.5 million in Q4 2021, up slightly from $3.3 million in Q4 2020. The increase is mainly attributable to the overall increase in business activities and increased activity in Europe. In Q4 2021, net finance costs were $1.8 million compared to $1.4 million in finance costs in Q4 2020.

這一增長主要是由於我們的腫瘤項目支出增加，包括 I 期試驗和 NASH III 期準備、醫療和患者教育支出增加以及歐洲更高的醫療事務計劃。在截至 2021 年 11 月 30 日的三個月期間，銷售費用為 820 萬美元，而去年同期為 650 萬美元。銷售費用的增加主要與在北美增加高級人員以建立更強大的銷售組織以及在 Trivarzo 在主要市場推出之前增加在歐洲的活動有關。 2021 年第四季度的 G&A 費用為 350 萬美元，略高於 2020 年第四季度的 330 萬美元。這一增長主要歸因於業務活動的整體增長和歐洲活動的增加。 2021 年第四季度，淨財務成本為 180 萬美元，而 2020 年第四季度的財務成本為 140 萬美元。

As previously stated, net finance costs comprised of interest on the convertible notes, foreign exchange variations as well as accretion expense and are offset by interest earned on our cash balance. For the fourth quarter of 2021, we recorded a negative EBITDA of $5.5 million compared to negative $1.4 million last year. The difference is mainly due to the higher net loss during the quarter. So reflecting the impact of the capital raise during Q1 of 2021, we ended the year with cash and cash equivalents of $40.4 million. So Paul will be back for final comments. But first, we will open the call to take your questions.

如前所述，淨財務成本包括可轉換票據的利息、外匯變動以及增值費用，並被我們的現金餘額賺取的利息所抵消。 2021 年第四季度，我們錄得 550 萬美元的負 EBITDA，而去年為負 140 萬美元。差異主要是由於本季度淨虧損較高。因此，為了反映 2021 年第一季度融資的影響，我們在年底的現金和現金等價物為 4040 萬美元。所以 Paul 會回來發表最後的意見。但首先，我們將打開電話以回答您的問題。

(Operator Instructions) Our first question comes from the line of Andre Uddin with Mackie Research.

（操作員說明）我們的第一個問題來自 Andre Uddin 與 Mackie Research 的合作。

Just had a few questions. When do you think we would see some Phase I 1902 safety data? And when do you think you would also start the Phase II/III NASH trial?

只是有幾個問題。您認為我們什麼時候會看到一些 I 期 1902 的安全數據？您認為您什麼時候也會開始 II/III 期 NASH 試驗？

TH1902, as we said, is about to finalize its maximum tolerated dose and the basket trial, I think, is going to be following right after. Christian, do you want to provide additional color to that?

正如我們所說，TH1902 即將確定其最大耐受劑量，我認為籃子試驗將緊隨其後。克里斯蒂安，你想為它提供額外的顏色嗎？

Yes, what we mentioned is that we have seen some DLT at 420 milligrams per meter square. We reduced the dose to 300 milligram per meter square, which is 1.5x the dose of docetaxel when given or administered alone, and this is a very good dose. And now we're proceeding with the study enrolling 3 patients looking at the DLT and the following 3 patients after that will be ready to open the basket trial. At this stage, based on the data that we have, we're not expecting any DLTs of 300. That will be known in the next 2, 3 months.

是的，我們提到的是，我們已經看到一些 DLT 的含量為每平方米 420 毫克。我們將劑量減少到每平方米 300 毫克，這是單獨給予或給藥時多西他賽劑量的 1.5 倍，這是一個非常好的劑量。現在我們正在進行這項研究，招募了 3 名查看 DLT 的患者，之後的 3 名患者將準備好開始籃子試驗。在現階段，根據我們擁有的數據，我們預計不會有任何 300 個 DLT。這將在接下來的 2、3 個月內得知。

When it comes to your second question, the NASH, we are about to file the amended protocol with the FDA. We expect a 30- to 40-day response from them. And following that, we'll have pretty much everything that is needed for us to actually clarify our plan forward. But this is a major decision that we've made and that we are announcing today because we -- doing so will allow us -- 350 patients have been treated to have hard endpoint data, which is very, very significant. And being able to go with the Phase IIb/III seamless protocol allows us to carry on with the recruitment of patients and therefore, not waste time.

關於你的第二個問題，NASH，我們即將向 FDA 提交修訂後的協議。我們預計他們會在 30 到 40 天內做出回應。之後，我們將擁有實際闡明我們未來計劃所需的幾乎所有內容。但這是我們做出的一項重大決定，我們今天要宣布這一決定，因為我們 - 這樣做將使我們 - 350 名患者接受了硬終點數據的治療，這非常非常重要。能夠採用 IIb/III 期無縫協議，我們可以繼續招募患者，因此不會浪費時間。

So I think we're going step-wise now. First, to confirm that this amended protocol is fine with the FDA; second, ensure that we can finance one way or another, either through a partnership or other financial means support at the beginning of the trial, and we will certainly get back to you as soon as we have a final decision made when it comes to that.

所以我認為我們現在正在逐步進行。首先，確認該修訂後的協議符合 FDA 的要求；其次，確保我們能夠在試驗開始時通過合夥或其他財務方式支持以一種或另一種方式提供資金，一旦我們做出最終決定，我們一定會盡快回复您.

That's great. Just also a couple of other questions. I was just wondering if there are any synergies with Rukobia and Trogarzo based on what was seen at the CRA conference this year?

那太棒了。還有其他幾個問題。我只是想知道，根據今年 CRA 會議上看到的情況，Rukobia 和 Trogarzo 是否有任何協同作用？

Yes. The -- so what we present like at the moment of what we have shown in our pivotal trial in the 40 patients, we had combination of Ibalizumab and Rukobia. And even if those are the 2 only fully active agent, we can control the viral. It becomes undetectable. And we see that, that combination is more and more used in the market. We also work with scientists that are assessing the synergy or additive effect of different drug in in vitro models, and those data will be presented most likely later this year. At the moment, what I can say is that with Rukobia, we see an additive effect, which is very, very good.

是的。我們在 40 名患者的關鍵試驗中展示了我們目前的情況，我們結合了 Ibalizumab 和 Rukobia。即使那些是唯一完全活躍的 2 代理，我們也可以控制病毒。它變得無法檢測。我們看到，這種組合在市場上的使用越來越多。我們還與科學家合作，在體外模型中評估不同藥物的協同作用或疊加效應，這些數據很可能會在今年晚些時候公佈。目前，我能說的是，對於 Rukobia，我們看到了一種加成效應，非常非常好。

Okay. And just one last one here. Just there was an independent Italian study last year showing that VAT levels predicted Covid ICU admission. And just wondering if there are any studies looking at EGRIFTA for this? And is there any law label use going on for EGRIFTA in this indication?

好的。這裡只有最後一個。去年意大利的一項獨立研究表明，增值稅水平可以預測 Covid ICU 的入院率。只是想知道是否有任何針對 EGRIFTA 的研究？ EGRIFTA 在此適應症中是否有任何法律標籤使用？

Andre, this is a very good question, and this was a very nice observation. And this -- there's the Italian study, but we had -- there were other also U.S. studies looking at the -- making the link between the significant amount of fat and more severe symptoms of COVID. And what we've done, it's really showing that VAT is not only cosmetic. It needs to be treated and physicians need to tackle that. And what we did, the medical team was able to talk to the [QO] about these data, these data was very well received. It was also included in our speaker program and the physician in our speaker program were able to talk about this. Then that's something which is important. And it shows that for like for us, it's in the HIV patient population, but that should be treated and making sure that it is reduced to the maximum.

安德烈，這是一個很好的問題，這是一個很好的觀察。這——有意大利的研究，但我們有——還有其他美國研究也在研究——在大量脂肪和更嚴重的 COVID 症狀之間建立聯繫。而我們所做的，確實表明增值稅不僅僅是裝飾性的。它需要治療，醫生需要解決這個問題。而我們所做的，醫療團隊能夠與 [QO] 討論這些數據，這些數據很受歡迎。它也包含在我們的演講者計劃中，我們演講者計劃中的醫生能夠談論這個。那就是重要的事情。它表明，對於我們來說，它存在於 HIV 患者群體中，但應該對其進行治療並確保將其減少到最大值。

Thank you, Christian. It further reinforces the fact that the VAT or lipodystrophy is a serious medical condition. So we're using the bulk of evidence in continuing medical education. And we think that more and more doctors will see for themselves that we are the only solution to treat lipodystrophy in HIV patients.

謝謝你，克里斯蒂安。它進一步強化了增值稅或脂肪營養不良是一種嚴重的疾病這一事實。所以我們在繼續醫學教育中使用大量證據。我們認為越來越多的醫生會親眼看到我們是治療 HIV 患者脂肪代謝障礙的唯一解決方案。

And our next question comes from the line of Endri Leno with National Bank.

我們的下一個問題來自國家銀行的 Endri Leno。

A few for me, but I'll start with the first one for Paul, perhaps. The question is on the sales force. What is the rationale for internalizing the sales force? And what do you plan to achieve that you're not achieving through the CSO?

一些給我，但我可能會從第一個給 Paul 開始。問題在於銷售人員。將銷售隊伍內部化的理由是什麼？您打算通過 CSO 實現哪些您沒有實現的目標？

Well, anyone in business will tell you that contract sales organizations are fine, but normally, you use a contract field force for only a period of time, either before you transition to something else or because you have a new indication and you want to have a surge that is not permanent in the type of activities that you want to have for the long run. So our rationale was if we want to beat the competition, if we want to be relevant, we want to actually produce the type of growth that we want to set for ourselves, we need to have a very engaged, very competent, very relevant field force.

好吧，商界的任何人都會告訴您合同銷售組織很好，但通常情況下，您只使用合同外勤人員一段時間，要么是在您過渡到其他機構之前，要么是因為您有新的適應症並且想要擁有在您希望長期進行的活動類型中，這種激增並不是永久性的。所以我們的理由是，如果我們想打敗競爭對手，如果我們想要相關，我們想要真正產生我們想要為自己設定的增長類型，我們需要有一個非常參與、非常有能力、非常相關的領域力量。

And I think that we wanted to see if we could move these products before initiating the transition because this is a significant endeavor. And as I highlighted in the speech, we were extremely pleased with the results we got in terms of new prescriptions, new enrollments in the latter part of the year last year as soon as we could execute on our strategies and tactics when it comes down to interacting face-to-face with physicians. So to me, that was a trigger and what we foresee is more effectiveness, field force effectiveness, more synergy with the medical field team. And all of that together will actually, I think, trigger superior engagement and superior results.

而且我認為我們想看看我們是否可以在開始過渡之前移動這些產品，因為這是一項重大的努力。正如我在演講中強調的那樣，我們對去年下半年在新處方、新入學方面取得的成果感到非常滿意，因為我們可以盡快執行我們的戰略和戰術，歸結為與醫生面對面交流。所以對我來說，這是一個觸發因素，我們預見的是更有效、現場部隊的有效性，以及與醫療現場團隊的更多協同作用。我認為，所有這些加起來實際上會引發更好的參與度和更好的結果。

John, do you want to add a few things?

約翰，你想補充幾件事嗎？

Yes. I mean, as with any product, I mean, having a highly engaged sales force is absolutely critical. And with a contract sales force, I think there's some inherent limitations. One, we had a fairly high turnover rate. And due to the nature of these -- the contracts could be somewhat transitory. And having our own people is going to be significantly -- be a significant benefit to these products. We also hired a VP of Sales last year that has significant experience in HIV. So we're in the process of building the capabilities of the sales force, and we think it's going to really pay big dividends in the coming months.

是的。我的意思是，與任何產品一樣，擁有一支高度敬業的銷售隊伍絕對至關重要。對於合同銷售人員，我認為存在一些固有的局限性。第一，我們的離職率相當高。由於這些合同的性質，合同可能有些臨時性。擁有我們自己的員工將對這些產品產生重大影響。我們去年還聘請了一位在 HIV 方面擁有豐富經驗的銷售副總裁。所以我們正在培養銷售隊伍的能力，我們認為這將在未來幾個月真正帶來豐厚的回報。

That is a great color. And one more follow-up on that. What would be the cost bump initially? And what kind of ROI are you targeting and any time lines you can give if you can to achieve an ROI with the internal life sales force?

那是一種很棒的顏色。還有一個後續行動。最初的成本增加是多少？您的目標投資回報率是多少？如果可以通過內部人壽銷售團隊實現投資回報率，您可以給出任何時間表？

Well, the cost is pretty much cost neutral because we did pay FD management fee to setting us to manage our operations. So we're no longer paying that. We do have to hire some more support staff. But the cost, in general, is neutral. It really is for the engagement, the lower turnover and the recruitment of top performers. So on a cost basis, it's pretty neutral, but it's really on the operations that -- where the impact is best seen.

好吧，成本幾乎是成本中性的，因為我們確實支付了 FD 管理費來讓我們管理我們的運營。所以我們不再付錢了。我們確實需要雇用更多的支持人員。但總的來說，成本是中性的。這確實是為了提高敬業度、降低人員流動率和招聘頂尖人才。因此，在成本的基礎上，它是相當中性的，但它實際上是在運營上——影響最明顯的地方。

Next question I have on Trogarzo. So first, if you can quantify what the flowback provisioning Trogarzo was this quarter, just more for modeling purposes. And the other question on Trogarzo is if you can give an update where it has gained reimbursement in Europe and what other countries are you targeting there?

下一個問題是關於 Trogarzo。因此，首先，如果您可以量化 Trogarzo 本季度的回流供應量，那麼更多的是用於建模目的。關於 Trogarzo 的另一個問題是，您是否可以提供最新情況，它在歐洲獲得報銷的地方以及您的目標國家是哪些？

Well, the situation in Europe is one country at a time. As you know, we got an indication for being able to commercialize by -- from EMA a while ago. But the negotiation is country by country. We've got some countries now where we have been able to negotiate a good price and no cap when it comes down to total number of patients we can recruit. There are some other countries where we have a good price, but we do have a cap. And there are some other countries in Europe, as you may imagine, where there's a direct relationship between pricing and volume.

好吧，歐洲的情況是一次一個國家。如您所知，不久前我們從 EMA 獲得了能夠商業化的跡象。但談判是逐個國家進行的。我們現在有一些國家，在涉及到我們可以招募的患者總數時，我們已經能夠談判一個好的價格並且沒有上限。在其他一些國家，我們的價格很好，但我們確實有上限。正如您想像的那樣，歐洲還有其他一些國家/地區的定價與銷量之間存在直接關係。

And for those, we are extremely careful before accepting an offering that would not allow us to actually promote for the long run based on the fact that we would not be able to reap the benefits of our investments. So we are negotiating with many countries. All the countries in Europe for which we have approvals are in scope, incidentally, we just negotiated a good price in Israel recently, and we will continue in smaller countries like Austria and like Norway, but the main countries for us in Europe is probably France. We find that there's a significant potential in Italy where we secured a price earlier last year, at the end of 2021.

對於那些人，我們在接受一項基於我們無法從投資中獲益的事實而不允許我們長期實際推廣的提議之前會非常小心。因此，我們正在與許多國家進行談判。我們獲得批准的所有歐洲國家都在範圍內，順便說一句，我們最近剛剛在以色列談判了一個好價格，我們將繼續在奧地利和挪威等較小的國家，但我們在歐洲的主要國家可能是法國.我們發現意大利有很大的潛力，我們去年早些時候在 2021 年底獲得了價格。

And we also have a great deal of expectation for a country like Portugal, that is a small country, but that carries a fair amount of HIV-1 patients. Spain is in scope, U.K. is in scope. And it's one country at a time, as I said, based on their way of negotiating. So we have to be customer-facing, customer-focused and it's one country at a time. And we'll let you know where it pans out in the end. But to answer your questions, all the countries are in scope. We just need to do the right negotiation and get out of the negotiation in a way where we could actually have a go-to-market model that makes sense for us.

我們也對像葡萄牙這樣的國家抱有很大的期望，它是一個小國家，但攜帶相當數量的 HIV-1 患者。西班牙在範圍內，英國在範圍內。正如我所說，這是一次一個國家，基於他們的談判方式。因此，我們必鬚麵向客戶，以客戶為中心，而且一次只針對一個國家。我們會讓您知道最終結果如何。但要回答您的問題，所有國家/地區都在範圍內。我們只需要進行正確的談判，並以一種我們實際上可以擁有對我們有意義的上市模式的方式退出談判。

Now I think your second question had to do with Trogarzo and the potential clawback. Is that what I heard? Philippe, do you want to take that one?

現在我認為你的第二個問題與 Trogarzo 和潛在的回扣有關。那是我聽到的嗎？菲利普，你要拿那個嗎？

Endri, we're not announcing the exact size of the provision. We're still in negotiation with the French government, so we want to keep that private for now. But what I can say is that we would have shown growth on the top line overall for the quarter if we hadn't had it. So that's all we're going to say right now.

Endri，我們不會宣布具體的撥款規模。我們仍在與法國政府進行談判，因此我們希望暫時保密。但我能說的是，如果我們沒有它，我們本季度的整體收入會出現增長。這就是我們現在要說的。

No, that's good color. That's good color. And just a couple quick ones for me on the development products, and I'll turn it over to the line. But on the NASH, the modified protocol, is this in response to any feedback you received during discussions with potential partners? Or is it an internally developed strategy?

不，那是很好的顏色。這個顏色好對我來說只是一些關於開發產品的快速介紹，我會把它交給生產線。但在 NASH 上，修改後的協議，這是對您在與潛在合作夥伴討論期間收到的任何反饋的回應嗎？還是內部製定的策略？

Well, it's twofold, I guess. We've been doing a fair bit of analysis to compare the benefits of doing a Phase IIb and then a Phase III trial. And quite frankly, a Phase IIb trial would be very similar to doing this interim analysis that we want to embed in our Phase III protocol. So we believe that we are good to go, and the agency believes that a long time ago because they gave us a study in the proceeds letter. But at the same time, chopping off the study in smaller bits from the financial point of view makes a great deal of sense and being able to have hard endpoint analysis after the first 350 patients are treated, makes also a lot of sense from both a science and a financing point of view.

好吧，我想這是雙重的。我們一直在進行大量分析，以比較進行 IIb 期試驗和進行 III 期試驗的好處。坦率地說，IIb 期試驗與進行我們希望嵌入到 III 期方案中的中期分析非常相似。所以我們相信我們很高興，而且該機構很久以前就相信，因為他們在收益信中給了我們一份研究。但與此同時，從財務角度來看，將研究分成較小部分非常有意義，並且能夠在首批 350 名患者接受治療後進行硬性終點分析，從兩個方面來看也很有意義科學和融資的觀點。

So we think that providing that the agency is fine with this approach, which is called seamless type of approach or protocol, I think we are going to have all the cards on the table for us to make a final decision. Christian, do you want to add to this?

因此，我們認為只要該機構接受這種稱為無縫類型的方法或協議的方法，我認為我們將把所有的牌都擺在桌面上，以便我們做出最終決定。克里斯蒂安，你想補充這個嗎？

No, I think that is.

不，我認為是。

Okay. Great. And then last one for me. On the oncology, the TH1902, the out-license in China, how imminent is this as a strategy, would you do it if you have content on the table at this point? Or would you wait until you have established the MTD and have some indication of activity from the PACE trial?

好的。偉大的。然後最後一個給我。在腫瘤學上，TH1902，在中國的許可外，作為一項戰略有多迫在眉睫，如果你現在有內容，你會去做嗎？或者您是否會等到您建立了 MTD 並從 PACE 試驗中獲得一些活動跡象？

Well, thanks for the question. I'll let Philippe answer that question. We are in negotiation with many companies. Some of them are very happy with what they've seen and already we have terms. Some others, it may actually turn to we want to see more. But what can we say? I think the overall objective here was to get a Chinese partner because we're not going to develop ourselves for the Chinese market. So we wanted someone to get involved as early as possible have as much as possible a parallel development track. And so obviously, if we contacted probably 100 companies and some of them said, we'd rather wait for Phase I data, but some of them are willing to take the risk. So we don't see why we should wait because there will be milestones associated to every regulatory and development hurdle that we go through. So really what we wanted to achieve was have someone as early as possible in the development so that they could help us bring the product forward on a global basis. So in... this is a value-generating strategy that we want to put forward.

好吧，謝謝你的提問。我會讓菲利普回答這個問題。我們正在與許多公司進行談判。他們中的一些人對他們所看到的非常滿意，我們已經有了條款。其他一些，它實際上可能會轉向我們想要看到更多。但是我們能說什麼呢？我認為這裡的總體目標是找到一個中國合作夥伴，因為我們不會為中國市場發展自己。所以我們希望有人儘早參與進來，盡可能多地並行發展。很明顯，如果我們聯繫了大約 100 家公司，其中一些公司表示，我們寧願等待第一階段的數據，但其中一些公司願意承擔風險。所以我們不明白為什麼我們應該等待，因為我們經歷的每一個監管和發展障礙都會有里程碑。所以我們真正想要實現的是儘早有人參與開發，以便他們可以幫助我們在全球範圍內推廣產品。所以在……這是我們想要提出的一個價值生成策略。

And I'm showing no further questions.

我沒有再提出任何問題。

Okay. So we'll take a few questions from the web platform, and there's quite a few on the oncology trial in terms of the selection of the de cancers that we'll be putting into the Phase Ib trial. So I'll read and paraphrase a few of them. So can you please clarify the Phase Ib cancer types and what informed the decision to add more types and to drug pancreatic and colorectal. And was that -- was it something that was seen in the trial or other work that you did?

好的。因此，我們將從網絡平台上回答幾個問題，在選擇我們將投入 Ib 期試驗的癌症方面，有很多關於腫瘤學試驗的問題。因此，我將閱讀並解釋其中的一些內容。那麼，您能否澄清 Ib 期癌症類型以及決定增加更多類型以及藥物胰腺和結直腸癌的原因。那是——它是在審判中看到的還是你所做的其他工作？

Yes. Well, thank you for the question. This is an important announcement that we've made today. And I wouldn't like anybody to actually see this as a drop of colorectal or pancreatic. You should see it the other way around. What we've done is that we are optimizing our basket trial to see early sign of efficacy, based on the sort on work that we've done to measure the expression of that receptor.

是的。嗯，謝謝你的問題。這是我們今天發布的重要公告。而且我不希望任何人將其視為結直腸或胰腺的一滴。你應該反過來看。我們所做的是，根據我們為測量該受體的表達所做的工作，我們正在優化我們的籃子試驗以查看療效的早期跡象。

Christian, do you want to say more?

克里斯蒂安，你想說更多嗎？

Yes. So, If you remember, the protocol was submitted to the FDA and completed a bit more than 1.5 years ago. But since then, we've done many, many analysis on different tumor types. And what we have seen is that, that sort of sector is significantly expressed in a large number of patients in all of the cancers that we've selected for the Phase I. And as Paul said, it's a better chance to have a sign of efficacy, but it's also a better chance to have a fast track to the FDA without a diagnostic test. And that's the goal at the moment.

是的。所以，如果你還記得的話，該協議是在 1.5 多年前提交給 FDA 並完成的。但從那以後，我們對不同的腫瘤類型做了很多很多分析。我們所看到的是，在我們為第一階段選擇的所有癌症中，大量患者都顯著表達了這種類型。正如保羅所說，這是一個更好的機會功效，但它也是一個更好的機會，可以在沒有診斷測試的情況下快速進入 FDA。這就是目前的目標。

And maybe just for colorectal cancer or pancreatic cancer, we've seen some expression, but it's only in the lower percentage of patients eventually, with the diagnostic test that could work as well. The initial goal is fast to market and the cancer types that are expressing the most of this [work the end]. So this is a very important point in today's conversation. We are just highlighting some -- or integrating some new learnings into our protocol so that we increase our chance of winning and driving an indication as fast as possible.

也許只是對於結直腸癌或胰腺癌，我們已經看到了一些表達，但最終只出現在較低比例的患者中，診斷測試也可能有效。最初的目標是快速推向市場，並且最能表達這一點的癌症類型 [工作到最後]。所以這是今天談話中非常重要的一點。我們只是強調一些——或將一些新知識整合到我們的協議中，以便我們盡快增加贏得和推動適應症的機會。

And maybe just to close on that, we are planning to either publish or present the results from the Sortilin work that we've been doing. So do you expect INR902 IND to be for all SORT1 or expressing solid tumors? Or will they be a Phase II, Phase III for each cancer type Jim?

也許只是為了結束這一點，我們計劃發布或展示我們一直在做的 Sortilin 工作的結果。那麼您是否期望 INR902 IND 適用於所有 SORT1 或表達實體瘤？或者它們將是每種癌症類型 Jim 的 II 期、III 期？

Yes. This is a very good question. It will depend on what we see in our basket trial. At the moment, most drugs are developed tumor type by tumor type. If we see more efficacy in one tumor type, we might use that approach because it will be faster to market. If we see similar efficacy in many different tumors, there could be a kind of a basket approach as well. But I think that it will most likely be a one-type cancer for the past.

是的。這個問題問得好。這將取決於我們在籃子試驗中看到的情況。目前，大多數藥物都是按腫瘤類型開發的。如果我們在一種腫瘤類型中看到更多療效，我們可能會使用這種方法，因為它可以更快地推向市場。如果我們在許多不同的腫瘤中看到相似的療效，那麼也可能會有一種籃子方法。但我認為它很可能是過去的一種癌症。

Okay. On TH1902, again, how serious were the adverse events in the cycles after the initial cycle?

好的。在 TH1902 上，初始週期後的周期中的不良事件有多嚴重？

Yes. What we've seen is our adverse events are linked to when you give a higher dose of docetaxel, at some point, you cannot reach or go higher to a certain level. And what you see with docetaxel, we've seen the same after 2, 3 cycles at to the signs of nerve toxicity that's seen with those impact. We've seen also some signs of digital electivity, same with docetaxel and some fatigue. Then we have a regular discussion with all of the investors taking part of the study and based on that observation, we decided to go to the 300 milligram per meter where we think that even if it's a 1.5x the dose of docetaxel, it will be much better tolerated, and we'll be able to give way more cycle at the 300-milligram square, which is the objective in treating advanced cancer patients.

是的。我們所看到的是，我們的不良事件與您給予更高劑量的多西他賽有關，在某些時候，您無法達到或提高到某個水平。你在多西紫杉醇上看到的情況，我們在 2、3 個週期後看到了與這些影響所見的神經毒性跡象相同的情況。我們還看到了一些數字選擇性的跡象，與多西紫杉醇和一些疲勞一樣。然後我們與所有參與研究的投資者進行定期討論，並根據觀察結果，我們決定採用每米 300 毫克的劑量，我們認為即使是多西紫杉醇劑量的 1.5 倍，它也將是更好的耐受性，我們將能夠在 300 毫克方允許更多的周期，這是治療晚期癌症患者的目標。

A question here. Will you be looking at other applications for the SORT1 receptor outside of oncology?

這裡有一個問題。您是否會關注 SORT1 受體在腫瘤學之外的其他應用？

We know that there could be some other applications based on SORT1 expressions in other parts of the body. But quite frankly, we've got our hands full now with SORT1 expression in oncology and its potential. You also heard that some companies have shown interest in our peptide as a carrier to get to the cancer cells. And we'll have to do a fair bit of education on the SORT1 receptor as we get into the basket trial so that people can understand how it works and why we have identified this entry to the cancer cells, while the vast majority of companies have not. So we've got to be very, very prudent here in the way that we spread ourselves and there are many additional applications outside of cancer, but this is not part of our journey at this time. Christian?

我們知道身體的其他部位可能還有一些基於 SORT1 表達式的其他應用程序。但坦率地說，我們現在已經忙於 SORT1 在腫瘤學中的表達及其潛力。您還聽說一些公司對我們的肽作為到達癌細胞的載體表現出興趣。當我們進入籃子試驗時，我們必須對 SORT1 受體進行一些教育，以便人們能夠理解它是如何工作的，以及為什麼我們已經確定了這個進入癌細胞的入口，而絕大多數公司已經不是。因此，我們在傳播自身的方式上必須非常、非常謹慎，除癌症外還有許多其他應用，但這不是我們目前旅程的一部分。基督教？

Okay. How long will it take to confirm safety at the 300 milligram level as you give a time line? Christian.

好的。 300 毫克級別的安全性需要多長時間才能確定？您給出了時間線？基督教。

So, I think what -- the way the product as said is what we recruit 3 patients. We need to hold them for 3 weeks, and there is no new -- we go to the next 3 patients hold them for 3 weeks after we will be ready for the basket trial. I think the one thing that we have to be careful in terms of time line, sometimes we have a patient who is almost ready to start, and there's a significant progression of the condition and the patient has to be excluded from the trial that there could be a bit more time in recruiting the patients. But I think within the next 2, 3 months, we should be able to confirm as we're moving ahead with the basket trial.

所以，我認為——產品所說的方式就是我們招募 3 名患者的方式。我們需要將它們保留 3 週，而且沒有新的——我們將在準備好進行籃子試驗後，讓下 3 名患者將它們保留 3 週。我認為我們在時間線方面必須小心的一件事是，有時我們有一個幾乎準備好開始的患者，並且病情有顯著進展並且患者必須被排除在試驗之外可能在招募患者方面多花點時間。但我認為在接下來的 2、3 個月內，我們應該能夠確認，因為我們正在推進籃子試驗。

I want people to understand. Thank you, Christian, that the dose escalation, unfortunately, is not always a straight line, and it could mean sometimes as you go one step forward to have one step backwards. And it looks like now we are really at the end of this process. So we need to confirm what just Christian highlighted in the next couple of weeks. And as soon as that confirmation is done, we'll actually start opening up at a different pace towards the basket trial.

我想讓人們明白。謝謝你，克里斯蒂安，不幸的是，劑量的增加並不總是一條直線，有時這可能意味著你向前邁出一步就會後退一步。看起來現在我們真的處於這個過程的末尾。因此，我們需要在接下來的幾週內確認克里斯蒂安剛剛強調的內容。一旦確認完成，我們實際上將開始以不同的速度開放籃筐試驗。

So last question on oncology, any upcoming conference presentations on cancer? I'm going to answer that. We can't really answer it, but we'll tell you that AACR is coming up and ASCO is coming up in June as well. So that's all we can say on that for now. There's a question on the estimated cost of pursuing the first 350 patients in NASH. And we're still working with our CRO on contributing the exact cost, but it should be in the $50 million range. So about 1/3 of the overall cost then for 1/3 of the patients.

那麼關於腫瘤學的最後一個問題，即將舉行的關於癌症的會議報告嗎？我要回答這個問題。我們無法真正回答，但我們會告訴您 AACR 即將到來，ASCO 也將在 6 月到來。所以這就是我們現在能說的。關於追踪前 350 名 NASH 患者的估計費用存在疑問。我們仍在與我們的 CRO 合作，以提供確切的成本，但它應該在 5000 萬美元的範圍內。因此，對於 1/3 的患者，大約佔總成本的 1/3。

And there's a question on the impact, again, on the cost impact on the sales force transition. As we said, there are a little bit of some upfront cost to set it up. But on a go-forward basis, it should be a cost control. So that confirms the -- concludes the Q&A session. So I'll hand it back over to Paul for closing remarks.

還有一個問題是成本對銷售人員轉型的影響。正如我們所說，設置它需要一些前期成本。但在前進的基礎上，它應該是成本控制。所以這證實了——結束問答環節。所以我會把它交還給 Paul 作結束語。

Well, thank you to everyone who joined our call today. We hope that we have clearly articulated that the 4 main drivers of Theratechnologies 2022 strategic operating plan. Our marching orders are rather clear and focused on these drivers, which includes, firstly, the rollout of our newly established internal sales and medical field force in support of our franchise activities. We believe our internal sales force will allow the company to be even more competitive in 2022 and beyond as we flex our superior ability to connect and engage with patients and providers in order to improve therapeutic outcomes.

好吧，感謝今天加入我們電話會議的所有人。我們希望我們已經清楚地闡明了 Theratechnologies 2022 戰略運營計劃的 4 個主要驅動因素。我們的行軍命令相當明確，並專注於這些驅動因素，其中首先包括推出我們新成立的內部銷售和醫療現場隊伍，以支持我們的特許經營活動。我們相信，我們的內部銷售團隊將使公司在 2022 年及以後更具競爭力，因為我們將發揮我們與患者和提供者聯繫和互動的卓越能力，以改善治療結果。

Second, from a financial metric perspective, it is our intent to build upon the momentum of the second half of fiscal 2021 and are targeting from 13% to 20% growth in our commercial portfolio now that face-to-face activities have mostly resumed. The continued commercial success of our brand is a strategic imperative and at the core of maintaining a fundamentally strong balance sheet as well as working capital defined activities. Third, we will continue to advance development of our oncology pipeline and the development of TH1902, for the treatment of solid metastatic and refractory cancers.

其次，從財務指標的角度來看，我們打算在 2021 財年下半年的勢頭基礎上再接再厲，鑑於面對面的活動已基本恢復，我們的商業投資組合目標是增長 13% 至 20%。我們品牌的持續商業成功是一項戰略要務，也是維持基本穩健的資產負債表和營運資本定義活動的核心。第三，我們將繼續推進我們的腫瘤管線開發和 TH1902 的開發，用於治療實體轉移性和難治性癌症。

In tandem to this R&D effort, we are exploring out-licensing development for TH1902in Greater China. In addition to partnership with other pharma and biotech companies who are interested in our peptide as a carrier to target cancer cells through SORT1 receptors. Lastly, we will continue to advance our Phase III NASH program. Partnering discussions around NASH carried over from 2021 eso continuing, while we seek nondiluted financing options for the program. Having filed an amended protocol with the FDA, we are moving the program forward, which will carry a significantly derisk development profile by assessing the efficacy of tesamorelin on a much smaller subset of patients.

為了配合這項研發工作，我們正在大中華區探索 TH1902 的對外許可開發。除了與其他對我們的肽感興趣的製藥和生物技術公司合作，將其作為載體通過 SORT1 受體靶向癌細胞。最後，我們將繼續推進我們的 III 期 NASH 計劃。圍繞 NASH 的合作討論從 2021 年開始繼續進行，同時我們為該計劃尋求非稀釋融資方案。在向 FDA 提交了一份修訂後的協議後，我們正在推進該計劃，該計劃將通過評估替沙莫林對一小部分患者的療效來顯著降低開發風險。

I would like to reiterate that we believe these driving forces will allow the companies to be even more competitive in 2022. And unlike a majority of early-stage biopharmaceutical companies are technologies commercial business vastly differentiates ourselves as we continue to work on our development pipeline of late and early-stage assets spread across several indications. And with this, thank you, everyone, for joining our fiscal review of the period. We look forward to the next set of quarterly financial and milestone updates as our story progresses. Have a great day, everyone.

我想重申，我們相信這些驅動力將使這些公司在 2022 年更具競爭力。與大多數處於早期階段的生物製藥公司不同的是，隨著我們繼續致力於我們的開發管道，技術商業業務使我們自己與眾不同晚期和早期資產分佈在多個適應症中。在此，感謝大家加入我們對這一時期的財政審查。隨著故事的進展，我們期待著下一組季度財務和里程碑更新。祝大家有個美好的一天。

This concludes today's conference call. Thank you for participating, and you may now disconnect.

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。