Theratechnologies Inc (THTX) 2022 Q2 法說會逐字稿

Good morning, and welcome to the Theratechnologies Second Quarter Fiscal Year 2022 Earnings Call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Elif McDonald, Senior Director of Investor Relations. Please go ahead.

早上好，歡迎來到 Theratechnologies 2022 財年第二季度收益電話會議。 （操作員說明）請注意正在記錄此事件。我現在想將會議轉交給投資者關係高級總監 Elif McDonald。請繼續。

Thank you, Andrea. Good morning, everyone. My name is Elif McDonald, and I recently joined Theratechnologies to lead the Investor Relations program. I'm thrilled to be here and look forward to working closely with the amazing team at Theratechnologies, our investors, analysts and capital market partners. I am especially excited about working with our outstanding management team and our exceptional Board of Directors. On the call today, you will be hearing from our President and Chief Executive Officer, Mr. Paul Lévesque and Senior Vice President and Chief Financial Officer, Mr. Philippe Dubuc. In addition, we will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer; and Mr. John Leasure, our Global Commercial Officer, for our Q&A session.

謝謝你，安德里亞。大家，早安。我叫 Elif McDonald，最近加入 Theratechnologies 領導投資者關係項目。我很高興來到這裡，並期待與 Theratechnologies 的優秀團隊、我們的投資者、分析師和資本市場合作夥伴密切合作。我對與我們傑出的管理團隊和傑出的董事會一起工作感到特別興奮。在今天的電話會議上，您將聽到我們的總裁兼首席執行官 Paul Lévesque 先生和高級副總裁兼首席財務官 Philippe Dubuc 先生的講話。此外，高級副總裁兼首席醫療官 Christian Marsolais 博士也將加入我們的行列；和我們的全球商務官 John Leasure 先生參加我們的問答環節。

Before we begin, I'd like to remind everyone that Theratechnologies' remarks today contain forward-looking statements regarding 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 obtained by the company will differ materially from those statements.

在我們開始之前，我想提醒大家，Theratechnologies 今天的評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，並且存在公司獲得的結果與這些陳述存在重大差異的風險。

As such, 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 filing issued this morning and available on SEDAR at www.sedar.com and on EDGAR at 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 將當前和潛在投資者引向其管理層討論和分析文件的前瞻性信息部分，該文件於今天上午發布，可在 SEDAR 網站 www.sedar.com 和 EDGAR 網站 sec.gov 上查閱。

Forward-looking statements represent Theratechnologies expectations as of July 13, 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. With that, I would now like to turn the conference over to Theratechnologies President and CEO, Paul Lévesque.

前瞻性陳述代表 Theratechnologies 截至 2022 年 7 月 13 日的預期，證券法可能要求的除外。 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。有了這個，我現在想把會議轉交給 Theratechnologies 總裁兼首席執行官 Paul Lévesque。

Thanks, Elif, and welcome to our team. Hello, everyone. I hope that everyone has had a good start to their summer, and thank you so much for joining the Theratechnologies team for our update call today. As we enter the second half of the fiscal year, we are making progress in real time across all of our strategic imperatives. What I mean by this, and as you've seen from our latest press releases, is that we've been very focused on our efforts to move the corporate needle forward and hit critical milestones for our commercial business and therapeutic pipeline.

謝謝，Elif，歡迎加入我們的團隊。大家好。我希望每個人的夏天都有一個好的開始，非常感謝您加入 Theratechnologies 團隊參加我們今天的更新電話會議。隨著我們進入本財年的下半年，我們在所有戰略要務方面都取得了實時進展。我的意思是，正如您從我們最新的新聞稿中看到的那樣，我們一直非常專注於努力推動公司發展，並為我們的商業業務和治療管道達到關鍵里程碑。

We are executing despite challenging times not only in the Bio Capital markets, but also the top overall macroenvironment, which has been affected by inflation, supply chain issue and geopolitical turmoil that we are witnessing on a daily basis. This is why the updates that we have provided this quarter, and there have been many as of recent, are helping to distinguish Theratechnologies from other health care names. Operationally, not only are we surviving through these tough moments, we are thriving.

儘管面臨挑戰，但我們仍在執行，不僅在生物資本市場，而且在整體宏觀環境中，我們每天都在目睹通貨膨脹、供應鏈問題和地緣政治動蕩的影響。這就是為什麼我們本季度提供的更新以及最近的更新有助於將 Theratechnologies 與其他醫療保健名稱區分開來。在運營上，我們不僅在這些艱難時刻倖存下來，而且還在蓬勃發展。

We announced yesterday that we successfully received a binding commitment letter from -- for a $100 million nondiluted term loan with Marathon Asset Management. The credit facility significantly strengthens our balance sheet and will make it possible to rapidly buy back and cancel $30 million of convertible notes due June 2023 through private agreements with certain U.S. noteholders. The financing stands as a testament to our unique investment proposition and a real vote of confidence from a world-class asset management firm that is well known for its excellence in producing risk-adjusted returns on behalf of their investor base.

我們昨天宣布，我們成功收到了來自馬拉松資產管理公司的 1 億美元非稀釋定期貸款的具有約束力的承諾函。信貸安排顯著加強了我們的資產負債表，並將通過與某些美國票據持有人的私人協議，快速回購和註銷 2023 年 6 月到期的 3000 萬美元可轉換票據成為可能。此次融資證明了我們獨特的投資主張，以及來自一家世界級資產管理公司的真正信任投票，該公司以其代表其投資者群體產生風險調整後回報的卓越表現而聞名。

Marathon's investment in Thera is indeed a show of support not only for our mission, track record of execution, but also for the whole management team. This morning, we announced an update on our TH1902 program, which highlighted our lead asset safety profile and tolerability. As Christian can further explain, pharmacokinetics data observed in humans showed low levels of free docetaxel, consistent with what was observed in the prior preclinical studies leading to a better safety profile than the use of cytotoxic alone.

Marathon 對 Thera 的投資確實表明了對我們使命、執行記錄以及整個管理團隊的支持。今天早上，我們宣布了 TH1902 計劃的更新，其中強調了我們的主要資產安全狀況和容忍度。正如 Christian 可以進一步解釋的那樣，在人體中觀察到的藥代動力學數據顯示游離多西紫杉醇水平較低，這與之前臨床前研究中觀察到的結果一致，從而導致比單獨使用細胞毒素更好的安全性。

As noted in the release, we established a safety profile at 300-milligram per square meter or 1.5x the therapeutic dose of docetaxel alone. Notably, 1 patient with endometrial cancer achieved stable disease over a 33-week period and was able to receive 11 cycles of TH1902. This is a clinically meaningful result in late-stage disease, where there are very limited treatment options. We also had 2 advanced prostate cancer patients who had progressed on standard chemo or hormone therapy. Both showed signs of efficacy.

如新聞稿中所述，我們建立了每平方米 300 毫克或單獨多西他賽治療劑量 1.5 倍的安全概況。值得注意的是，一名子宮內膜癌患者在 33 週內病情穩定，能夠接受 11 個週期的 TH1902。對於治療選擇非常有限的晚期疾病，這是一個具有臨床意義的結果。我們還有 2 名晚期前列腺癌患者，他們在標準化療或激素治療方面取得了進展。兩者均顯示出療效跡象。

The first patient achieved a confirmed partial response with a tumor mass reduction of 53% and the other patient achieved a PSA response with stabilization of disease without any further progression. Given that, on average, patients received 8 rounds of treatment prior to TH1902. We are very encouraged by this update. It is meaningful and gives us hope that we can help improve patient outcomes and change the lives of those touched by hard and very hard-to-treat cancers.

第一位患者實現了確認的部分反應，腫瘤質量減少了 53%，另一位患者實現了 PSA 反應，疾病穩定，沒有任何進一步的進展。鑑於此，平均而言，患者在 TH1902 之前接受了 8 輪治療。我們對這次更新感到非常鼓舞。它很有意義，讓我們希望能夠幫助改善患者的治療效果並改變那些患有難治性癌症的人的生活。

Building on our oncology pipeline update, we are so pleased to note that the CQDM-Quebec Biopharmaceutical Research Consortium has provided a new cancer research grant to validate the entire metastatic potential of TH1902. The CQDM, together with the Quebec Breast Cancer Foundation and [my tax] announced a contribution of more than CAD 1 million for a new research project at ’Université du Québec à Montréal, focused on several metastatic cancer models. In particular, this new investment will further expand our knowledge in advanced metastatic breast cancer. This public private partnership complements a Theratechnologies annual investment in the development of our targeted oncology platform using TH1902 in breast cancer and could increase the spectrum of patients -- for cancer patients who might ultimately benefit from this new therapy.

基於我們的腫瘤管線更新，我們很高興地註意到 CQDM-魁北克生物製藥研究聯盟提供了一項新的癌症研究資助，以驗證 TH1902 的全部轉移潛能。 CQDM 與魁北克乳腺癌基金會和 [my tax] 一起宣佈為魁北克蒙特利爾大學的一個新研究項目捐款超過 100 萬加元，該項目專注於幾種轉移性癌症模型。特別是，這項新投資將進一步擴大我們在晚期轉移性乳腺癌方面的知識。這種公私合作夥伴關係補充了 Theratechnologies 的年度投資，用於開發我們在乳腺癌中使用 TH1902 的靶向腫瘤學平台，並可能增加患者的範圍——對於可能最終受益於這種新療法的癌症患者。

Now let's look at this past quarter's event. As noted in today's earnings press release, we have executed on our strategic plans in the quarter, including our decision to focus sales efforts on the U.S., which is our strongest core market. As announced in April 2022, we made the decision to return commercialization rights of Trogarzo in Europe to our business partner, TaiMed Biologics, who owns the molecule. A notice of termination has been sent to TaiMed, and the transition will be complete by the end of October 2022. Despite this decision, TaiMed remains a very strong strategic partner for us.

現在讓我們看看上個季度的事件。正如今天的收益新聞稿所述，我們在本季度執行了我們的戰略計劃，包括我們決定將銷售工作重點放在我們最強大的核心市場美國。正如 2022 年 4 月宣布的那樣，我們決定將 Trogarzo 在歐洲的商業化權利歸還給我們的業務合作夥伴 TaiMed Biologics，後者擁有該分子。終止通知已發送給 TaiMed，過渡將於 2022 年 10 月完成。儘管做出了這一決定，TaiMed 仍然是我們非常強大的戰略合作夥伴。

While we had every intention of bringing Trogarzo to Europe patients, it became clearer through pricing and reimbursement discussions with local governments that we would not be able to carry a viable and sustainable business in the region. We recognize the uncertainty, the situation may have cause for key stakeholders, especially patients, and we remain absolutely committed to a smooth transition back to TaiMed, and we'll continue to provide all necessary support for them to make important decisions concerning European patients' access to Trogarzo, a treatment whose therapeutic benefits have been proven.

雖然我們完全有意將 Trogarzo 帶給歐洲患者，但通過與當地政府的定價和報銷討論，我們變得更加清楚，我們無法在該地區開展可行和可持續的業務。我們認識到不確定性，這種情況可能對主要利益相關者，尤其是患者造成影響，我們仍然絕對致力於順利過渡回 TaiMed，我們將繼續為他們提供一切必要的支持，以做出有關歐洲患者的重要決定獲得 Trogarzo，一種治療效果已被證實的療法。

The shift in focus to the U.S. and the time to make the appropriate operational transition narrows our revenue range, so roughly the midpoint of our forecasted 2022 guidance. As we expect our top line revenue to be within $79 million and $82 million for the full 2022 fiscal year. Commercially, we remain on track with our financial goals as consolidated sales grew 8.3% to $19.3 million for the quarter, reflective of the momentum built up in our sales strategy. Year-to-date, revenue grew 13.9% to $37.8 million which puts us well within striking distance to meet or better exceed our targeted fiscal year guidance.

將重點轉移到美國以及進行適當的運營轉型的時間縮小了我們的收入範圍，因此大致是我們預測的 2022 年指導的中點。正如我們預計的那樣，我們的 2022 財年全年收入將在 7900 萬美元和 8200 萬美元之間。在商業方面，我們繼續實現我們的財務目標，本季度綜合銷售額增長 8.3% 至 1,930 萬美元，這反映了我們銷售戰略中建立的勢頭。年初至今，收入增長 13.9% 至 3780 萬美元，這使我們距離達到或更好地超過我們的目標財政年度指導目標很近。

In looking at Q2 versus Q1 patient enrollment numbers for the year, EGRIFTA SV enrollment grew by 48% and Trogarzo by 26%. Combined quarterly patient enrollment growth was 19% year-over-year. We believe this meaningful increase was driven by the return of in-person patient visits in doctors' offices following the easing of pandemic restrictions. Supporting these solid top line numbers has been the onboarding of our dedicated commercial sales force in the U.S., which is now complete. Moreover, we have made key additions across the company in line with our corporate strategy and to support our ongoing and expanded projects.

在查看今年第二季度與第一季度的患者註冊人數時，EGRIFTA SV 註冊人數增長了 48%，Trogarzo 增長了 26%。合併的季度患者註冊人數同比增長 19%。我們認為，這一有意義的增長是由於大流行病限制放寬後，患者再次到醫生辦公室就診。支持這些穩固的收入數字的是我們在美國的專業商業銷售團隊的入職，該團隊現已完成。此外，我們根據公司戰略對整個公司進行了重要的補充，以支持我們正在進行的和擴展的項目。

We are pleased to welcome new team members to Theratechnologies and look forward to their contributions in leadership in their respective roles. I think we have some of the brightest and best talent in the industry and the business, and I appreciate their hard work and dedication to the mission and purpose of our company.

我們很高興歡迎新的團隊成員加入 Theratechnologies，並期待他們在各自的角色中發揮領導作用。我認為我們擁有行業和業務中一些最聰明、最優秀的人才，我感謝他們的辛勤工作和對公司使命和宗旨的奉獻。

Exiting the first half of 2022, we continue to be pleased with the recapitalization of the company as it allows us to continue to grow our commercial business to scale. Furthermore, we believe this supports our future revenue growth, which we are driving through evaluating and extending the life cycle management of our existing commercial products while successfully moving our lead oncology asset through its larger basket trial. Additionally, out-licensing, development and commercialization rights for TH1902 in Greater China, continue to move forward. We are very excited to showcase our dose escalation data to further these discussions and continue to move forward with an increasing number of potential partners.

2022 年上半年結束後，我們繼續對公司的資本重組感到高興，因為它使我們能夠繼續擴大我們的商業業務規模。此外，我們相信這支持我們未來的收入增長，我們正在通過評估和擴展現有商業產品的生命週期管理來推動收入增長，同時通過更大規模的籃子試驗成功轉移我們的領先腫瘤學資產。此外，TH1902在大中華區的對外許可、開發和商業化權利也在繼續推進。我們非常高興能夠展示我們的劑量遞增數據，以進一步推進這些討論，並繼續與越來越多的潛在合作夥伴一起前進。

Now, let me update the market with regards to life cycle management of our commercial business at a high level. In March 2021, we submitted an amendment to the FDA to the instructions For Use section that is included in the EGRIFTA SV patient information. This followed some complaints the company received from patients related to the reconstitution of EGRIFTA SV after its launch in 2019. Along with these new instructions, we now provide patients with detailed training through our call center and the number of complaints have dropped dramatically. The FDA responded to our amendment outside of the time line set forth in the regulation with a complete response letter asking the company to carry out a human factor study to ensure that patients reconstitute the product in the proper manner.

現在，讓我向市場更新有關我們商業業務生命週期管理的高層次信息。 2021 年 3 月，我們向 FDA 提交了對 EGRIFTA SV 患者信息中包含的使用說明部分的修正案。在此之前，該公司在 EGRIFTA SV 於 2019 年推出後收到了一些患者關於重組 EGRIFTA SV 的投訴。除了這些新說明，我們現在通過我們的呼叫中心為患者提供詳細培訓，投訴數量大幅下降。 FDA 在法規規定的時間範圍之外回應了我們的修正案，並發出了一封完整的回复信，要求該公司進行人為因素研究，以確保患者以正確的方式重構產品。

We have recently initiated the study, which we believe will be carried out to the FDA satisfaction and also within their imposed time frame of 1 year. This request does not affect the commercial availability of EGRIFTA SV. As previously announced, our intention was to file an sBLA for the F8 formulation by the end of the first quarter of calendar 2022. Unfortunately, the issue around the global supply of bacteriostatic water for injection required for the reconstitution of the F8 formulation has not been resolved. According to the FDA website, the estimated recovery of supply back to bacteriostatic water is scheduled for October 2022.

我們最近啟動了這項研究，我們相信該研究將在 FDA 規定的 1 年時限內完成並令 FDA 滿意。此請求不會影響 EGRIFTA SV 的商業可用性。正如之前宣布的那樣，我們的意圖是在 2022 日曆年第一季度末之前提交 F8 製劑的 sBLA。不幸的是，有關重構 F8 製劑所需的抑菌注射用水的全球供應問題尚未得到解決。解決。據 FDA 網站稱，預計將在 2022 年 10 月恢復供應抑菌水。

In addition, since the FDA has asked us to perform a human factor study for the reconstitution of EGRIFTA SV, we have proactively decided to carry out the study before filing the sBLA for the F8 formulation. As such, we will be filing the sBLA for the F8 once we have consistent sourcing of bacteriostatic water for injection and have completed the human factor study.

此外，由於 FDA 要求我們對 EGRIFTA SV 的重構進行人為因素研究，我們已主動決定在提交 F8 製劑的 sBLA 之前進行該研究。因此，一旦我們穩定地採購注射用抑菌水並完成人為因素研究，我們將為 F8 提交 sBLA。

Now I'd like to provide an update on NASH. The NASH program is still on pause pending the sourcing of bacteriostatic water and the securing of a partner with resources and capabilities. After internal discussions and to further derisk the Phase III trial, the company has submitted an amended protocol to the FDA. The new protocol, a Phase IIb/III seamless study design includes an interim analysis of the first 350 or so patients. This data will be analyzed by a data monitoring committee to assess the efficacy of tesamorelin and will allow us to generate hard endpoint data on NAS score and fibrosis. A decision will then be made whether to continue the study until the full number of patients, 1094, have completed 18 months of treatment.

現在我想提供有關 NASH 的最新消息。 NASH 計劃仍處於暫停狀態，等待抑菌水的採購和獲得具有資源和能力的合作夥伴。經過內部討論並進一步降低 III 期試驗的風險，該公司已向 FDA 提交了修訂後的方案。新協議是一項 IIb/III 期無縫研究設計，包括對前 350 名左右患者的中期分析。該數據將由數據監測委員會進行分析，以評估替沙莫林的療效，並使我們能夠生成有關 NAS 評分和纖維化的硬終點數據。然後將決定是否繼續研究，直到所有患者（1094 名）完成 18 個月的治療。

The FDA has agreed to this redesigned protocol. We continue to have discussion with potential NASH partners and are very encouraged to see renewed NASH interest and recent industry partnership announcement. Finally, on Trogarzo, an sBLA was filed with the FDA in the fourth quarter of 2021 for the company's IV push mode of administration for the treatment of HIV patients. The FDA has accepted our filing and has provided a target date of October 3, 2022, in accordance with the Prescription Drug User Fee Act.

FDA 已經同意這個重新設計的協議。我們繼續與潛在的 NASH 合作夥伴進行討論，並且非常高興看到 NASH 重新引起人們的興趣和最近的行業合作夥伴關係公告。最後，在 Trogarzo 上，該公司於 2021 年第四季度向 FDA 提交了一份 sBLA，用於該公司治療 HIV 患者的 IV 推動給藥模式。 FDA 已接受我們的申請，並根據《處方藥用戶費用法》規定了 2022 年 10 月 3 日的目標日期。

Theratechnologies and TaiMed are also evaluating an intramuscular mode of administration for Trogarzo within the TMB-302 study. This trial is now fully enrolled, and we expect completion of the study in the second half of 2022. That covers our updates for the quarter, and I would like now to pass the call to Philippe, our CFO. Philippe?

Theratechnologies 和 TaiMed 還在 TMB-302 研究中評估 Trogarzo 的肌內給藥模式。該試驗現已全部註冊，我們預計該研究將在 2022 年下半年完成。這涵蓋了我們本季度的更新，現在我想將電話轉給我們的首席財務官 Philippe。菲利普？

Thanks, Paul. So I will review the financials before I turn the call over to the operator to start the Q&A. Consolidated revenues for the 3-month period ended May 31 was $19.3 million compared to $17.8 million for the same quarter a year ago, representing a year-over-year increase of 8.3%. For the second quarter of fiscal 2022, net sales of EGRIFTA SV reached $11.4 million compared to $10.3 million in Q2 of the prior year representing an increase of 10.3% over the second quarter of 2021 due to the combined effect of a higher number of units sold and a higher net selling price.

謝謝，保羅。因此，在將電話轉給接線員開始問答之前，我會先查看財務狀況。截至 5 月 31 日的三個月合併收入為 1930 萬美元，而去年同期為 1780 萬美元，同比增長 8.3%。 2022 財年第二季度，EGRIFTA SV 的淨銷售額達到 1140 萬美元，而去年第二季度為 1030 萬美元，由於銷量增加的綜合影響，比 2021 年第二季度增長 10.3%以及更高的淨售價。

In the second quarter of fiscal '22, Trogarzo net sales amounted to $7.9 million compared to $7.4 million for the same quarter last year, representing an increase of 5.5%. Higher sales of Trogarzo were a result of a stronger performance in the United States, where we recorded 14% growth compared to the same quarter last year. Trogarzo sales were, on the other hand, hampered by lower sales in Europe as a result of a weaker overall pricing environment.

在 22 財年第二季度，Trogarzo 的淨銷售額為 790 萬美元，而去年同期為 740 萬美元，增長了 5.5%。 Trogarzo 的銷售額增加是由於在美國的表現更強勁，與去年同期相比，我們在美國錄得 14% 的增長。另一方面，由於整體定價環境較弱，Trogarzo 的銷售受到歐洲銷售額下降的阻礙。

In Q2 2022, cost of goods sold was $7.8 million compared to $4.7 million for the same quarter last year. The increase in cost of goods sold was mainly due to a onetime charge arising from the non-production of scheduled batches of EGRIFTA SV that were canceled due to the planned transition to the F8 formulation of tesamorelin. Cost of goods sold was also impacted by higher sales of both EGRIFTA SV and Trogarzo, but we're generally in line on a percentage basis with prior periods costs.

2022 年第二季度，銷貨成本為 780 萬美元，而去年同期為 470 萬美元。銷售成本的增加主要是由於 EGRIFTA SV 的預定批次未生產而產生的一次性費用，這些批次因計劃過渡到 tesamorelin 的 F8 製劑而被取消。銷售成本也受到 EGRIFTA SV 和 Trogarzo 銷售額增加的影響，但我們通常按百分比與前期成本保持一致。

R&D expenses amounted to $11 million for the 3-month period ended May 31, 2022, compared to $6.4 million for the same period last year. The increase is largely due to higher spending related to the ongoing Phase I trial of TH1902. In 2022, we have also initiated important studies related to medical education and real-world patient follow-up in the HIV field, namely the VAMOS and PROMISE trials in the U.S.

截至 2022 年 5 月 31 日的三個月期間，研發費用為 1100 萬美元，而去年同期為 640 萬美元。這一增長主要是由於與正在進行的 TH1902 I 期試驗相關的支出增加。 2022年，我們還啟動了與HIV領域的醫學教育和真實世界患者隨訪相關的重要研究，即美國的VAMOS和PROMISE試驗。

Increased spending in R&D is also related to the ongoing trial evaluating the intramuscular form of administration of Trogarzo, which has reached full enrollment and is on track for completion later this year. Selling expenses amounted to $15.4 million for the second quarter compared to $6.9 million for the same period last year. This increase is mainly due to the accelerated amortization of the rights associated to the commercialization of Trogarzo in Europe, following our decision to terminate our commercial agreement with TaiMed for this territory. This represents a noncash charge of $6.4 million.

研發支出的增加也與正在進行的評估 Trogarzo 肌肉注射形式的試驗有關，該試驗已達到全部註冊人數，並有望在今年晚些時候完成。第二季度的銷售費用為 1540 萬美元，而去年同期為 690 萬美元。這一增長主要是由於在我們決定終止與 TaiMed 在該地區的商業協議後，與 Trogarzo 在歐洲商業化相關的權利的加速攤銷。這代表 640 萬美元的非現金費用。

The increase in selling expense also includes onetime costs related to the setting up of our internal field force in the United States, as well as spending on new initiatives implemented in 2022 to increase awareness of our products in the North American market. G&A expenses in Q2 amounted to $4.8 million compared to $3.8 million reported in Q2 of 2021. The increase in G&A expenses is largely due to increased overall business activities in 2022 compared to 2021, as well as to key hires in North America to support the implementation and management of our internal field force in the U.S.

銷售費用的增加還包括與在美國建立內部現場工作人員相關的一次性成本，以及 2022 年為提高我們的產品在北美市場的知名度而實施的新舉措的支出。第二季度的 G&A 費用為 480 萬美元，而 2021 年第二季度為 380 萬美元。G&A 費用的增加主要是由於與 2021 年相比，2022 年的整體業務活動有所增加，以及在北美招聘主要人員以支持實施和管理我們在美國的內部現場隊伍

Net finance costs for the 3 months ended May 31 were $1.6 million compared to $1 million for the comparable period in 2021. Net finance costs in both the second quarter of 2022 and 2021 include interest of $833,000 on the senior convertible notes issued in June of 2018. Net finance costs also included accretion expense of $544,000 in the second quarter of 2022, compared to $608,000 for the comparable period last year. The remainder of the difference can be explained by a foreign currency loss in 2022 as opposed to foreign currency gain in the same period of last year.

截至 5 月 31 日的三個月的淨財務成本為 160 萬美元，而 2021 年同期為 100 萬美元。2022 年第二季度和 2021 年第二季度的淨財務成本包括 2018 年 6 月發行的優先可轉換票據的利息 833,000 美元淨財務成本還包括 2022 年第二季度 544,000 美元的增加費用，而去年同期為 608,000 美元。其餘差異可以用 2022 年的外匯損失而非去年同期的外匯收益來解釋。

Given the increase in revenue and the increased expenses, the impairment of the Trogarzo commercialization rights for the European territory as well as other nonrecurring charges explained earlier, net loss for the quarter amounted to $22.7 million compared to $6.4 million for the same period last year. We ended the second quarter of fiscal '22 with $32.5 million in cash, bonds and money market funds. The company that believes that its cash position and future operating cash flows will be sufficient to finance its operation and capital needs for at least the next 12 months for the consolidated statement of financial position date. Furthermore, subsequent to May 31, 2022, as announced yesterday, the company secured a new nondilutive $100 million term loan facility with Marathon Asset Management, significantly strengthening our balance sheet and allowing us to rapidly retire $30 million principal amount of convertible debentures.

考慮到收入增加和支出增加、Trogarzo 在歐洲地區的商業化權利減值以及之前解釋的其他非經常性費用，本季度淨虧損為 2270 萬美元，而去年同期為 640 萬美元。我們以 3250 萬美元的現金、債券和貨幣市場基金結束了 22 財年第二季度。認為其現金狀況和未來經營現金流量足以為其合併財務狀況表日至少未來 12 個月的經營和資本需求提供資金的公司。此外，在昨天宣布的 2022 年 5 月 31 日之後，公司與 Marathon Asset Management 獲得了一項新的非稀釋性 1 億美元定期貸款，顯著加強了我們的資產負債表，並使我們能夠迅速收回 3000 萬美元的可轉換債券本金。

Funding of this first tranche of the term loan facility for $40 million is planned before the end of July, at which time we will retire the $30 million of convertible notes, which we will acquire at a discount to par. For the 3-month period ended May 31, cash flows used by operating activities were $11.7 million compared to $2.8 million in the same period of fiscal 2021. In the second quarter of fiscal '22, changes in operating assets and liabilities had a positive impact on cash flow of $10.6 million, or as in 2021, these had a $2.1 million positive impact on cash flow. These changes were mostly attributable to positive impact from lower accounts receivables, lower prepaid expenses by approximately $1 million each, as well as higher accounts payable and grew liabilities of $7.1 million.

計劃在 7 月底之前為第一筆 4000 萬美元的定期貸款提供資金，屆時我們將收回 3000 萬美元的可轉換票據，我們將以低於面值的價格收購這些票據。截至 5 月 31 日的三個月期間，經營活動使用的現金流量為 1170 萬美元，而 2021 財年同期為 280 萬美元。在 22 財年第二季度，經營資產和負債的變化產生了積極影響以 1060 萬美元的現金流量或與 2021 年一樣，這些對現金流量產生了 210 萬美元的積極影響。這些變化主要歸因於應收賬款減少、預付費用減少約 100 萬美元以及應付賬款增加和負債增加 710 萬美元的積極影響。

We are tightening our fiscal '22 revenue guidance range of $79 million to $82 million or a growth of the commercial portfolio to be in the range of 13% to 17% as compared to 2021. The adjustments reflected our lower expectations from sales of Trogarzo in Europe, as we begin the transition period of commercial rights back to TaiMed.

與 2021 年相比，我們正在收緊 22 財年 7900 萬美元至 8200 萬美元的收入指導範圍，或者將商業投資組合的增長率控制在 13% 至 17% 之間。這些調整反映了我們對 Trogarzo 在歐洲，因為我們開始將商業權利交還給 TaiMed 的過渡期。

With that, Paul will be back for final comments. But first, we'll open the call to take your questions. We also have questions from the webcast, so I will moderate these after the analysts. Operator?

有了這個，保羅將回來發表最後的評論。但首先，我們將打開電話以回答您的問題。我們也有來自網絡廣播的問題，所以我會在分析師之後調節這些問題。操作員？

(Operator Instructions) And our first question will come from Edward Nash of Canaccord Genuity.

（操作員說明）我們的第一個問題將來自 Canaccord Genuity 的愛德華納什。

So I just wanted to understand -- so we're basically just about flat, maybe a little bit down on EGRIFTA quarter-over-quarter sequentially. And just for modeling purposes, just kind of what are the thoughts as we go out for the rest of the year? Will we expect more of the growth in you hitting your revenue estimate numbers to be coming from U.S. sales of Trogarzo? Or do you expect to see a little bit more of a bump up on EGRIFTA?

所以我只是想了解 - 所以我們基本上持平，可能比 EGRIFTA 季度環比略有下降。僅出於建模目的，我們在今年餘下的時間里外出時有什麼想法？我們是否會期望您達到收入預估數字的更多增長來自 Trogarzo 在美國的銷售？還是您希望在 EGRIFTA 上看到更多的提升？

Well, thank you, Ed, for the question. Glad you picked this up because let me just highlight a few numbers here again. The year-to-date growth for EGRIFTA after 6 periods is almost 22% in dollars. And what I said in my speech is that Q2 over Q1, this year, the growth of EGRIFTA was almost 48%. So the drug is really carrying a significant momentum. You know it's our most profitable product, and we have a great deal of aspiration for it. But having a drug that has been on the market for a number of years, growing at 22% in sales after 6 period is a great deal of satisfactory to me. So John, do you want to provide additional color?

嗯，謝謝你，艾德，提出這個問題。很高興你選擇了這個，因為讓我在這裡再次強調幾個數字。 EGRIFTA 在 6 個時期後的年初至今增長接近 22%（以美元計算）。而我在演講中所說的是，今年第二季度超過第一季度，EGRIFTA 的增長率幾乎達到 48%。因此，這種藥物確實具有巨大的發展勢頭。你知道這是我們最賺錢的產品，我們對它抱有很大的期望。但是擁有一種上市多年的藥物，在 6 期後銷售額增長了 22%，這讓我非常滿意。那麼約翰，你想提供額外的顏色嗎？

On top of that, we achieved those results during the period of transition with our sales force. We just launched a new sales force in May, and we're starting to see some real benefits from that. So we -- although we've had good growth for the first 6 months, we expect further momentum in the second half of the year.

最重要的是，我們在銷售團隊的過渡期間取得了這些成果。我們剛剛在 5 月推出了一支新的銷售隊伍，我們開始看到一些真正的好處。所以我們 - 儘管我們在前 6 個月取得了良好的增長，但我們預計今年下半年會有進一步的增長勢頭。

Makes sense, and that's really helpful. And just the last question I had is just, could you help me understand. So I know that the issue with the F8 formulation is related to the bacteriostatic water. But how is that different what we're currently seeing with EGRIFTA SV because when you [send] EGRIFTA SV, it's -- bacteriostatic water is included with the SV formulation, right, for reconstitution. So just trying to understand how the bacteriostatic water has not affected the EGRIFTA SV availability as well.

有道理，這真的很有幫助。我的最後一個問題是，你能幫我理解一下嗎？所以我知道F8配方的問題與抑菌水有關。但是，我們目前看到的 EGRIFTA SV 有何不同，因為當你[發送] EGRIFTA SV 時，它是——SV 配方中包含抑菌水，對，用於重建。所以只是想了解抑菌水如何不影響 EGRIFTA SV 的可用性。

Thanks, Ed, for your question. That will allow us to clarify -- there's a big difference between the F8 and the F4. The F8 is once a week reconstitution, and that's why you need to have special waters "to ensure that the solutions will actually be fine for a full week. " Christian, do you want to provide additional color?

謝謝，艾德，你的問題。這將使我們能夠澄清——F8 和 F4 之間存在很大差異。 F8 每週配製一次，這就是為什麼您需要特殊的水“以確保溶液在整整一周內都沒有問題。”克里斯蒂安，您想提供額外的顏色嗎？

Yes, absolutely. This is bacteriostatic water for injection that we use for -- because it is 1 vial for 7 doses. Then you pull the vial on a daily basis, then you need the bacteriostatic in the vial -- which we don't have for the F4 because the F4 is a daily reconstitution. Then you add the water, you take your injection and you throw everything in the garbage. That's the main reason of the difference between the 2.

是的，一點沒錯。這是我們使用的抑菌注射用水——因為它是 1 瓶 7 劑。然後你每天拉動小瓶，然後你需要小瓶中的抑菌劑——我們沒有 F4，因為 F4 是每日重構。然後你加水，打針，然後把所有東西都扔進垃圾桶。這是兩者之間差異的主要原因。

The next question comes from Andre Uddin of Research Capital. Please go ahead.

下一個問題來自 Research Capital 的 Andre Uddin。請繼續。

Just assuming the push dose of Trogarzo was approved October 3, when do you expect to launch it? And do you anticipate taking down any of the current formulation inventory prior to launch?

假設 Trogarzo 的推動劑量在 10 月 3 日獲得批准，您預計什麼時候推出它？您是否預計會在發布前取消任何當前的配方庫存？

Thank you, Andre. We do have a PDUFA date of October 3, as we said, and I just want to insist we're going to maximize the launch of this formulation. I think it's going to be communicating ease of administration to our users and patients. John, do you want to provide color on the launch?

謝謝你，安德烈。正如我們所說，我們的 PDUFA 日期確實是 10 月 3 日，我只是想堅持我們將最大限度地推出這個配方。我認為這將向我們的用戶和患者傳達易於管理的信息。約翰，你想在發佈時提供顏色嗎？

Well, yes, we're preparing to launch in Q4, October time frame. But it's important to recognize that while the dosage -- the method of administration may be different, the actual dose, the product is the same. So there's no need to run down inventory.

嗯，是的，我們正準備在 10 月的第四季度推出。但重要的是要認識到，雖然劑量——給藥方法可能不同，但實際劑量、產品是相同的。所以沒有必要減少庫存。

Okay. That's great. And just -- and also just looking at the F8 formulation and the sterile water situation, once you do get consistent supply, what human study do you actually need to do? And about how long do you think that would take before you can then file an sBLA from when you start the study? Thank you.

好的。那太棒了。只是 - 也只是看看 F8 配方和無菌水的情況，一旦你得到穩定的供應，你實際上需要做什麼人體研究？從您開始研究開始，您認為需要多長時間才能提交 sBLA？謝謝。

Yes. Thank you. The human factor study that we have proactively decided to do with the F8 is identical as the one that is now required by the FDA on the F4. Christian, the methodology is very simple, right?

是的。謝謝。我們主動決定對 F8 進行的人為因素研究與 FDA 現在要求對 F4 進行的研究相同。 Christian，方法很簡單，對吧？

Yes, it is simple and it is something we work at the company that has the expertise in this field, then like it's a study that will be completed in time for submission. But I want also to address the other part of your question in terms of which study was done. In terms of the bioequivalence, we have done the exact same thing as what was done for the F4, and that study is already completed and well, they have shown bioequivalence between the F8 and the F1 then this part of the trial is completed.

是的，這很簡單，而且我們在擁有該領域專業知識的公司工作，然後就像一項研究將及時完成以提交。但我還想根據完成的研究來解決你問題的另一部分。在生物等效性方面，我們做了與 F4 完全相同的事情，並且該研究已經完成，並且他們已經證明 F8 和 F1 之間的生物等效性，然後這部分試驗就完成了。

Okay. That's great. And but how long would that take about, do you think, to run that new study once you get...

好的。那太棒了。但是，你認為，一旦你得到...，進行這項新研究需要多長時間？

The human factor study that we're thinking about a period of about 12 months to run a study like this one because there's 2 parts. There's a part which is a formative part. After that, we need to get feedback from the FDA, which is about 70 days. And after that, we do what we call the [SUMMIT] of study and submit the results to the FDA, the 9 to 12 months to be completed.

人為因素研究，我們正在考慮大約 12 個月的時間來運行這樣的研究，因為它有 2 個部分。有一部分是形成性的部分。之後，我們需要得到 FDA 的反饋，大約需要 70 天。之後，我們進行所謂的 [SUMMIT] 研究，並將結果提交給 FDA，需要 9 到 12 個月才能完成。

Okay, great. And Christian, just also since I have you here, the 1902 data looks promising as -- and I was just wondering what criteria did you use to actually select the cancer indications that are developed for the basket trial?

好的，太好了。克里斯蒂安，也正是因為我有你在這裡，1902 年的數據看起來很有希望——我只是想知道你使用什麼標準來實際選擇為籃子試驗開發的癌症適應症？

Yes, for the basket trial, well, for the dose escalation were -- first of all, we're very encouraged by those results because those were all comers. And as you know, we start at the very low dose. We have patients that received 420, and we have to stop treatment because of the -- some of the toxicity that we've seen, and those are very advanced patients. The average number of cycles that we have received is 8 and the fact that we see like signs -- good signs of efficacy in 3 patients is very good.

是的，對於籃子試驗，嗯，因為劑量增加是——首先，我們對這些結果感到非常鼓舞，因為這些都是來者不拒的。如您所知，我們從非常低的劑量開始。我們有接受 420 名患者的患者，由於我們已經看到的一些毒性，我們不得不停止治療，而且這些患者都是非常晚期的患者。我們收到的平均週期數是 8 個，事實上我們看到了類似的跡象——3 名患者的療效良好跡象非常好。

For the basket trial, what we have done, we've been -- we've done -- since we acquired the technology, we have done a lot of biopsy analysis. We call this TMA then on 1 slide for the microscope, you get something like 300 biopsies of different patients. And this is the way we selected the patient for the basket trial. We took the patient that are the highest or tumor type that are the highest expressers of the sortilin receptor, mainly TNBC, hormone receptor, positive breast cancer, ovarian cancer, endometrial cancer, melanoma. But we also included a basket, and the basket based on very encouraging results in prostate cancer, there will be additional patients with prostate cancer that will be enrolled. Thyroid cancer is a very high expressor of the sortilin receptor will also be included, as well as small cell lung cancer. And if we find the basket of the basket is to have an investigator to enroll additional patients that would be high expressure of the receptor.

對於籃子試驗，我們所做的，我們已經——我們已經完成了——自從我們獲得這項技術以來，我們已經做了很多活檢分析。我們稱此為 TMA，然後在一張顯微鏡載玻片上，您會得到大約 300 個不同患者的活檢組織。這就是我們為籃子試驗選擇患者的方式。我們選取分揀蛋白受體表達量最高或腫瘤類型最高的患者，主要是 TNBC、激素受體、陽性乳腺癌、卵巢癌、子宮內膜癌、黑色素瘤。但我們也包括了一個籃子，這個籃子基於非常令人鼓舞的前列腺癌結果，將有更多的前列腺癌患者被納入。甲狀腺癌是分揀蛋白受體的非常高的表達者，也將包括在內，還有小細胞肺癌。如果我們發現籃子中的籃子是讓調查員招募更多受體高表達的患者。

Thank you, Andre, for your question. But just to summarize because it can be complex. Christian has selected different tumors for which we know the SORT1 expression is high. So we are increasing our likelihood of getting early signs of efficacy fast. And according to what we're going to see since we have a fast track designation, should we see back-to-back efficacy in 1 cancer or tumor, we will strategize and interact with the agency to see how we can accelerate the development of our compounds for at least 1 indication. So we've designed the basket trial to be large, but this is going to be helpful because all of those tumors from what we know are expressing SORT1 at a very high level.

謝謝你，安德烈，你的問題。但只是總結一下，因為它可能很複雜。 Christian 選擇了我們知道 SORT1 表達高的不同腫瘤。因此，我們正在增加快速獲得早期療效跡象的可能性。根據我們將要看到的，因為我們有一個快速通道指定，如果我們看到一種癌症或腫瘤的背靠背療效，我們將製定戰略並與該機構互動，看看我們如何能夠加速發展我們的化合物至少有 1 個適應症。所以我們設計了大型的籃子試驗，但這將很有幫助，因為我們所知道的所有這些腫瘤都以非常高的水平表達 SORT1。

(Operator Instructions) And our next question will come from Endri Leno of National Bank.

（操作員說明）我們的下一個問題將來自國家銀行的 Endri Leno。

And the first one, I'll continue with 1902. And the question I had there for Christian perhaps is can you talk a little bit -- and congrats on those encouraging results that you got. Can you talk a bit about the assessment of the treatment response in prostate cancer? And what is the most accepted (inaudible) reduction in lesions, reduction in PSA-OS or PFS or any of those?

第一個，我將繼續 1902 年。我想問 Christian 的問題可能是你能談談——並祝賀你取得了令人鼓舞的結果。你能談談前列腺癌治療反應的評估嗎？什麼是最被接受（聽不見）的病變減少、PSA-OS 或 PFS 或其中任何一項的減少？

Yes, absolutely. The prostate cancer patient that was enrolled in the study, first of all, was a very advanced in the treatment. This is a patient that received a total of 10 different treatments before being enrolled in this study. The last 2 treatment that we received before enrollment, 1 was docetaxel and received only 4 cycles before disease progression. And after that, the patient received cabazitaxel, which is another taxane and received only 2 cycles. After that, the patient was enrolled in the study with our product, is linked to docetaxel.

是的，一點沒錯。首先，被納入研究的前列腺癌患者的治療非常先進。這是一名在參加本研究之前總共接受了 10 種不同治療的患者。我們在入組前接受的最後 2 次治療，其中 1 次是多西紫杉醇，並且在疾病進展前僅接受了 4 個週期。之後，患者接受了卡巴他賽，這是另一種紫杉烷類藥物，僅接受了 2 個週期。之後，患者使用我們的產品參加了研究，該產品與多西紫杉醇有關。

And what we've seen according to the RECIST criteria is a partial response and the total reduction in the tumor size, the 1 that we target for initially for assessing the response was 53%. And that's very significant based on the fact that, that patient was already progressing on docetaxel and cabazitaxel. The second patient in terms of prostate cancer patient was also a patient that was advanced in treatment received 3 prior treatment and had disease progression on hormone therapy. The patient was enrolled in this study. And what we've seen -- and the patient was enrolled at 420-milligram per meter square, received 3 cycles and after that, 2 cycles up 300. This is at the time that we started to lower the dose to aim at 300 as the basket trial goes.

根據 RECIST 標準，我們看到的是部分反應和腫瘤大小的總減少，我們最初用於評估反應的目標是 53%。這非常重要，因為該患者已經在多西他賽和卡巴他賽上取得進展。就前列腺癌患者而言，第二位患者也是治療晚期的患者，其接受過 3 次既往治療並且在激素治療中出現疾病進展。患者參加了這項研究。我們所看到的——患者以每平方米 420 毫克的劑量入組，接受了 3 個週期，然後是 2 個週期，達到 300。此時我們開始將劑量降低到 300，因為籃子試驗開始了。

And this patient had a significant response on TSA. The TSA level returned to the baseline volume in the normal range, and the patient that's a stable disease with a slight reduction in the 1-digit reduction. But something which is important is that the patient did not stop the study because of disease progression. The patient stopped the study, most likely because of some of the toxicities at 420. The patient has bit of neuropathy, which we don't see at 300 so far, then that's the reason why you stop. Then those results are very encouraging.

這個病人對 TSA 有顯著的反應。 TSA 水平恢復到正常範圍內的基線體積，患者病情穩定，略有下降 1 位數。但重要的是患者沒有因為疾病進展而停止研究。患者停止了研究，很可能是因為 420 時的一些毒性。患者有一點神經病，我們目前在 300 時沒有看到，這就是你停止的原因。那麼這些結果是非常令人鼓舞的。

And maybe finally, regarding the endometrial cancer patients. This is also a patient that as after we see before the entry in our study, the combination of carboplatin and paclitaxel, the patient couldn't receive those cycles or that treatment for more than 3 cycles, and the reason because the patient had adverse effects. Then the patient after that was switched in our trial. The patient started at 60 milligrams. That was 1 of the early patients, but the patient was like we have seen disease stabilization, and we were able to increase because you know that in that part of the study, we can do dose escalation on patient after those other cycles are up. And that patient went up to 360 milligrams per meter square for a total of 11 cycle, 33 weeks with stable disease.

也許最後，關於子宮內膜癌患者。這也是一位患者，因為我們在進入我們的研究之前看到，卡鉑和紫杉醇的組合，患者無法接受那些週期或超過 3 個週期的治療，原因是患者有不良反應.然後患者在我們的試驗中被調換。患者開始服用 60 毫克。那是早期患者中的 1 名，但患者就像我們看到疾病穩定一樣，我們能夠增加，因為你知道在研究的那部分，我們可以在其他週期結束後對患者進行劑量遞增。那個病人每平方米增加了 360 毫克，總共 11 個週期，33 周病情穩定。

And once again, the patient did not stop the study because of disease progression. The patient wanted to go back to a normal life. We discussed with [the site]. It doesn't look like the patient had any significant adverse events linked to the drug, but it's only a question of getting back to a normal life. That's why we're fairly happy with those 3 signs of efficacy and very difficult to treat patients.

再一次，患者沒有因為疾病進展而停止研究。病人想回到正常的生活。我們與 [網站] 進行了討論。看起來患者沒有任何與藥物相關的重大不良事件，但這只是恢復正常生活的問題。這就是為什麼我們對這 3 個療效跡象和非常難以治療的患者感到相當滿意。

Okay. And just 1 follow-up. I mean, would you want or would you have to see TSA reduction to to call it, let's say, a success or a proper response or just because it's so advanced that could -- does not necessarily have to be the case?

好的。並且只有 1 次跟進。我的意思是，您是否希望或必須看到 TSA 縮減為稱其為成功或適當的回應，或者僅僅因為它是如此先進以至於可以 - 不一定必須如此？

It's usually a combination of both. But if you have a reduction in tumor that lasts for a long period of time, this is a response, especially in that patient population, especially in the patient that was progressing on docetaxel then we will continue now to enroll patients in the basket trial. And if we see similar efficacy in similar patients, this is where we will have to make a decision as to how we move forward in 1 of those cancer type. And we'll certainly have a discussion with the FDA at some point will be to increase from 10 to 25 patients and after that with the Phase II. But as Paul was saying or I said before, we're still like on the fast track, and our goal is to be fast to market, then we'll discuss with experts and the FDA to ensure that we have the proper design to get to market as fast as possible.

它通常是兩者的結合。但是如果你的腫瘤減少持續很長一段時間，這是一種反應，特別是在那個患者群體中，特別是在多西他賽治療進展的患者中，那麼我們現在將繼續在籃子試驗中招募患者。如果我們在相似的患者身上看到相似的療效，這就是我們必須決定如何在其中一種癌症中取得進展的地方。我們肯定會在某個時候與 FDA 討論將患者從 10 名增加到 25 名，然後再進行 II 期試驗。但正如 Paul 所說或我之前所說，我們仍然處於快車道上，我們的目標是快速上市，然後我們將與專家和 FDA 討論以確保我們有合適的設計來獲得盡快推向市場。

Thank you very much. One more question. It's more on the cost side. I hear if you guys can talk a bit about the human factor study, if you have any cost estimates? And then overall cost for the company, how do you see them progressing for the second half of the year? And that's it for me.

非常感謝。還有一個問題。更多的是在成本方面。我聽說你們是否可以談談人為因素研究，如果你們有任何成本估算？然後是公司的總體成本，您如何看待他們下半年的進展？對我來說就是這樣。

I'm not sure, Endri, that we picked up your questions, but I just want to say it again. We have implemented -- Christian has implemented some solutions that actually has reduced the number of complaints dramatically. That's what I said, and that is true. However, the FDA has asked us just to conduct a human factor study to ensure that the leaflet that is in the patient's hands, is absolutely perfect. And the human factor study is not a great deal. This is something that many other companies have to do. And we have already appointed a firm that does that all the tim,e, it succeeds. So Christian, I mean, just like for the F8, we're going to do it proactively. The F4, we have to do it but the point is, is that this is not a great deal.

Endri，我不確定我們是否回答了你的問題，但我只想再說一遍。我們已經實施 - Christian 已經實施了一些解決方案，這些解決方案實際上大大減少了投訴數量。我就是這麼說的，這是真的。然而，FDA 只要求我們進行一項人為因素研究，以確保患者手中的傳單絕對完美。人為因素研究不是很多。這是許多其他公司必須做的事情。我們已經任命了一家公司，它一直在這樣做，而且它很成功。所以克里斯蒂安，我的意思是，就像 F8 一樣，我們將積極主動地去做。 F4，我們必須這樣做，但重點是，這不是什麼大不了的事。

No, this is the companies that have -- or many other products, the company that was selected was successful at 20 of those HFS study. It is really to enroll (inaudible) like volunteer and patients that will mimic or that will reconstitute the drug to ensure that they inject the proper volume of drug at the end of the study. That's something relatively easy to do.

不，這是擁有——或許多其他產品的公司，被選中的公司在 20 項 HFS 研究中取得了成功。它真的是像志願者和患者一樣註冊（聽不清），他們將模仿或重新配製藥物，以確保他們在研究結束時注射適當體積的藥物。這是相對容易做到的事情。

Okay, thank you. And what would you estimate the cost could be for the HFS study?

好的謝謝。您估計 HFS 研究的成本是多少？

The cost of these trials are about depending on how long they take it. It's between $650,000 and $800,000 to carry out.

這些試驗的費用大約取決於他們需要多長時間。執行費用在 650,000 美元到 800,000 美元之間。

Okay. Okay. That's not bad. And then the other part of the question for the overall cost of the company, I was asking, how do you see them progressing for the second half of the year? Do you see them more stable or accelerating a bit if you pick up patient recruitment?

好的。好的。那還不錯。然後是關於公司整體成本的問題的另一部分，我問的是，你如何看待他們下半年的進展？如果你接受患者招募，你會看到他們更穩定還是加速一點？

On the trials, the oncology trial can keep progressing a little bit, but not all that much. And the rest of the company, we've had a lot of onetime costs in the first half of setting up the the commercial operations, the intramuscular study of Trogarzo will also decelerate in spending because enrollment -- full enrollment has been reached, and we're winding that down. So costs will be stable to -- stable for the rest of the year.

在試驗中，腫瘤學試驗可以繼續取得一點進展，但不會那麼多。和公司的其他人一樣，我們在建立商業運營的上半年有很多一次性成本，Trogarzo 的肌肉注射研究也將減少支出，因為註冊已經達到完全註冊，我們正在結束它。因此，今年剩餘時間成本將保持穩定。

Thank you for your question. And I see that there's a great deal of interest this morning about the TH1902 release that we had. I just wanted to stress something again before we take the additional questions we have. The dose escalation for us was very, very interesting. But the goal of a dose escalation, first and foremost, and I just want to say it again, is to determine the dose and the safety and tolerabilitty at that dose that you're going to use in the basket trial afterwards or the Phase Ib.

謝謝你的問題。我看到今天早上人們對我們發布的 TH1902 版本非常感興趣。在我們回答其他問題之前，我只是想再次強調一些事情。對我們來說，劑量增加非常非常有趣。但劑量遞增的目標，首先也是最重要的，我只想再說一遍，是確定您將在之後的籃子試驗或 Ib 期中使用的劑量以及該劑量的安全性和耐受性.

And we're very, very happy to have seen that the free docetaxel level is very similar to what we saw in the animal model, which tells us that there's something going on probably through the SORT1 receptor as per the preclinical model. So this is very encouraging. And on top of that, what Christian highlighted, is that we picked up 3 patients where we certainly have very interesting signs of efficacy that obviously needs to confirm or to be confirmed in the second part of the Phase I. But for now, we're very pleased and the market was in a waiting mode for this, and we wanted this morning to communicate as much as we could at this time on the escalation trial.

我們非常非常高興地看到游離多西他賽水平與我們在動物模型中看到的非常相似，這告訴我們根據臨床前模型可能通過 SORT1 受體發生了一些事情。所以這是非常令人鼓舞的。最重要的是，克里斯蒂安強調的是，我們挑選了 3 名患者，我們肯定有非常有趣的療效跡象，顯然需要在第一階段的第二部分確認或待確認。但就目前而言，我們我們非常高興，市場對此處於等待狀態，我們希望今天早上就升級試驗盡可能多地進行溝通。

Okay. So there are no more questions from analysts. So we do have a few questions from the webcast. And the first 1 is on the -- if we can be more clear on the toxicity profile that we've seen at the 300 dose. So we have mentioned no DLPs, but are there any AEs or serious adverse events that we've seen so far at 300?

好的。因此，分析師沒有更多問題。所以我們確實有一些來自網絡廣播的問題。第一個是——如果我們能更清楚地了解我們在 300 劑量下看到的毒性特徵。所以我們沒有提到 DLP，但是到目前為止我們在 300 處是否有任何 AE 或嚴重不良事件？

Yes. In terms of the 300 dose at the moment, Garrison] then, as mentioned in the question, DLPs after the first cycle. We didn't see any serious adverse events on the patient that's received that treatment. And none of the patients stopped the treatment because of adverse events. We have seen, as we mentioned before, for 20-some visual equity changes, we have 1 patient that had an adverse events related to what we see in the eye to some extent. But now we're putting preventative measures like eye drops. And this is something similar to what's happening also with the ADC. The ADCs are leading also to those adverse events. And it's nothing something that -- it's not something that is of a concern by us at this stage, neither the investigators participating in the trial.

是的。就目前的 300 劑量而言，Garrison] 然後，如問題中所述，第一個週期後的 DLP。我們沒有看到接受該治療的患者有任何嚴重的不良事件。並且沒有患者因為不良事件而停止治療。正如我們之前提到的，我們已經看到，對於 20 多項視覺公平性變化，我們有 1 名患者的不良事件在某種程度上與我們在眼睛中看到的相關。但現在我們正在採取預防措施，比如滴眼藥水。這與 ADC 正在發生的事情類似。 ADC 也導致了這些不良事件。在現階段，這不是我們關心的問題，參與試驗的調查人員也不是。

Okay. And there's a corollary to that. Where do you think the 420-milligram had toxicities came from, if there isn't much free docetaxel?

好的。這有一個必然結果。如果游離的多西紫杉醇不多，您認為 420 毫克的毒性從何而來？

Well, the toxicities are selling to some extent, to docetaxel and 1 of the toxicity that we have seen is, neuropathy. And we know that the SORT1 receptor is also expressed on neurons and that could be delaying for the neuropathy similar to what we've seen. We've seen 1 grade 4 neutropenia that lasted for more than 7 days. And once again, it is linked also to docetaxel, but this is not something that we have observed at this stage at the dose of 300.

好吧，毒性在某種程度上被賣給了多西紫杉醇，而我們所看到的毒性之一是神經病變。我們知道 SORT1 受體也在神經元上表達，這可能會延遲類似於我們所見的神經病變。我們已經看到 1 例 4 級中性粒細胞減少症持續超過 7 天。再一次，它也與多西紫杉醇有關，但這不是我們現階段在 300 劑量下觀察到的情況。

And here's what added info on the partial response, patients total tumor (inaudible) changes.

這是關於部分反應、患者總腫瘤（聽不清）變化的附加信息。

Maybe I would expect to have a partial response according to the RECIST criteria. What we do, we measure the total tumor size. And sometimes there's more. There are metastasis, and in the case of that patient, we -- the first CT scan got after 6 weeks, and there was a repeated CT scan. To confirm the partial response, you need to have a follow-up CT scan following the initial response. And the total burden like the decrease was about 53%. The exact size and total size of the tumors, I don't remember. But I can say that 1 metastasis disappeared completely from the CT scan. Then that's the sign, which is very encouraging. And we mentioned also in the past that the SORT1 receptor is often more expressed in metastasis, and those are very encouraging signs that are linked with our mechanism of action.

也許我希望根據 RECIST 標準得到部分響應。我們所做的是測量腫瘤的總大小。有時還有更多。有轉移，就那個病人而言，我們在 6 週後進行了第一次 CT 掃描，並進行了重複的 CT 掃描。要確認部分反應，您需要在初始反應後進行後續 CT 掃描。總負擔如減少約53%。腫瘤的確切大小和總大小，我不記得了。但我可以說 1 個轉移灶從 CT 掃描中完全消失了。那就是標誌，這是非常令人鼓舞的。我們過去也提到過 SORT1 受體通常在轉移中表達更多，這些都是與我們的作用機制相關的非常令人鼓舞的跡象。

Okay. Thanks for telling that. The others have been pretty much answered in your comments. There's 1 that is inquiring about the agreed price with the convertible buyback. We're not disclosing it. These are private purchases, but you can assume that it's around a 5% discount to par that we were able to negotiate. So there are no more questions at this time. So operator, I'll turn the call back over to -- sorry, to Paul for closing remarks.

好的。謝謝你這麼說。其他人在您的評論中已經得到了相當多的回答。有 1 個正在詢問可轉換回購的約定價格。我們沒有透露它。這些是私人購買，但您可以假設它比我們能夠協商的面值折扣大約 5%。所以現在沒有更多的問題了。所以接線員，我將把電話轉回——抱歉，轉給 Paul 作結束語。

Thank you, team, and thank you guys on the line for your questions. I know this is an exciting time for us. Today's remarks ran a bit longer than usual due to all of our great progress. I just wanted to conclude with some important key takeaways here in this early midterm of the 2022 year.

謝謝你們，團隊，也謝謝你們在線提問。我知道這對我們來說是一個激動人心的時刻。由於我們取得了巨大進步，今天的發言比平時要長一些。我只想在 2022 年的這個早期中期總結一些重要的關鍵要點。

Theratechnologies is currently hitting on all of our execution marks in realizing the future of the company in the here and now. Most recently, the validation that we receive for our investment thesis and the associated capital infusion that came with it is a real vote of confidence. This is the case despite the challenging market for small cap biotech where financings are just not getting done.

Theratechnologies 目前正在觸及我們所有的執行標記，以實現公司在此時此地的未來。最近，我們收到的投資論點的驗證以及隨之而來的相關資本注入是真正的信任投票。儘管小型生物技術市場充滿挑戰，融資仍未完成，但情況仍然如此。

The second important takeaway is that we have successfully reached the end of the dose escalation portion in TH1902, and have established our go-forward dose. We now expect new data to be potentially released in the back half of 2022 with regards to early efficacy of our basket trial. This will be followed in Q1 of 2023 by a presentation of the complete data set for the dose escalation study, which has already established dose limiting toxicity in addition to the go-forward dose.

第二個重要的收穫是我們已經成功地完成了 TH1902 中劑量遞增部分的末尾，並確定了我們的前進劑量。我們現在預計可能會在 2022 年下半年發布有關我們籃子試驗早期療效的新數據。隨後將在 2023 年第一季度展示劑量遞增研究的完整數據集，該研究已經確定了劑量限制毒性以及前進劑量。

As we have witnessed from the strategic adjustments to our commercial business development pipelines and life cycle management of our franchises, we are optimizing our capital allocation in a difficult marketplace to create an efficient organization with a critical infrastructure to succeed across all of our endeavors. With this, I look forward to seeing everyone on the next update call. Thank you. Have a great day and a great summer.

正如我們從我們的商業業務發展渠道和特許經營生命週期管理的戰略調整中看到的那樣，我們正在困難的市場中優化我們的資本配置，以創建一個擁有關鍵基礎設施的高效組織，以在我們所有的努力中取得成功。有了這個，我期待在下一次更新電話會議上見到大家。謝謝。祝你有美好的一天和美好的夏天。

The conference has now concluded. Thank you for attending.

會議現已結束。感謝您的出席。