Theratechnologies Inc (THTX) 2023 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, and welcome to the Theratechnologies Q3 2023 Earnings Conference Call. (Operator Instructions) This event is being recorded.

    美好的一天,歡迎參加 Theratechnologies 2023 年第三季財報電話會議。 (操作員說明)正在記錄此事件。

  • I would now like to turn the conference over to John Mullaly. Please go ahead.

    我現在想把會議交給約翰·穆拉利。請繼續。

  • John Mullaly - MD

    John Mullaly - MD

  • Thank you, operator, and good morning, everyone. On the call today will be Theratechnologies's President and Chief Executive Officer; Mr. Paul Lévesque; and Senior Vice President and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer; and Mr. John Leasure, the company's Global Commercial Officer.

    謝謝接線員,大家早安。今天參加電話會議的是 Theratechnologies 的總裁兼執行長;保羅‧萊維斯克先生;資深副總裁兼財務長 Philippe Dubuc 先生。資深副總裁兼首席醫療官 Christian Marsolais 博士將參加問答環節;以及公司全球商務官 John Leasure 先生。

  • Before we begin, I'd like to remind everyone that remarks today contain forward-looking statements regarding the company's current and future plans, expectations and intentions with respect to future events. Forward-looking statements are based on assumptions, and there are risks that results obtained by Theratechnologies may differ materially from those statements. As such, the company cannot guarantee any forward-looking statements will materialize, and you are cautioned not to place undue reliance on them.

    在開始之前,我想提醒大家,今天的言論包含有關公司當前和未來計劃、對未來事件的期望和意圖的前瞻性陳述。前瞻性陳述基於假設,Theratechnologies 所獲得的結果可能與這些陳述有重大差異。因此,公司不能保證任何前瞻性陳述都會實現,並提醒您不要過度依賴它們。

  • The company refers current and potential investors to the forward-looking information section of Theratechnologies management discussion and analysis issued this morning and available on SEDAR, www.sedar.ca. And on EDGAR at www.sec.gov.

    該公司建議當前和潛在投資者參閱今天早上發布的 Theratechnologies 管理層討論和分析的前瞻性資訊部分,該部分可在 SEDAR(www.sedar.ca)上取得。以及 www.sec.gov 上的 EDGAR。

  • Forward-looking statements represent Theratechnologies' expectations as of this morning, September 26, 2023. Additionally, today, the company is using the term adjusted EBITDA, which is not a financial measure under International Financial Reporting Standards, IFRS or U.S. generally accepted accounting principles, U.S. GAAP. Adjusted EBITDA excludes the effects of items that primarily reflect the impact of long-term investments and financing decisions rather than the result of day-to-day operations.

    前瞻性聲明代表了Theratechnologies 截至2023 年9 月26 日上午的預期。此外,今天,該公司使用調整後EBITDA 一詞,該術語不是國際財務報告準則、國際財務報告準則或美國公認會計原則下的財務衡量標準,美國公認會計原則。調整後 EBITDA 不包括主要反映長期投資和融資決策影響而非日常營運結果的項目的影響。

  • Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one to another. The company uses this non-IFRS measure to make financial, strategic and operating decisions. Reconciliation of adjusted EBITDA to net loss is found in our MD&A issued this morning available on SEDAR and on EDGAR at the web addresses -- mentioned earlier. Investors can also follow the company on LinkedIn and Twitter and sign up for alerts on Theratechnologies investor website at theratec.com.

    Theratechnologies 認為,這項指標可以成為衡量其營運績效和財務狀況的有用指標。公司使用此非國際財務報告準則衡量標準來制定財務、策略和營運決策。調整後的 EBITDA 與淨虧損的調節可在我們今天早上發布的 MD&A 中找到,可在 SEDAR 和 EDGAR 上找到,網址為前面提到的。投資者還可以在 LinkedIn 和 Twitter 上關注該公司,並在 Theratec.com 投資者網站上註冊接收提醒。

  • With that, I would now like to turn the conference over to Theratechnologies President and CEO, Paul Lévesque.

    現在,我想將會議轉交給 Theratechnologies 總裁兼執行長 Paul Lévesque。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Thank you, John. Hello, everyone, and good morning. I'm pleased to report that we have made fantastic headway across our strategic objectives as outlined in this morning's press release. Our financial and operational planning for the remainder of the year and into 2024 is well in hand. And in spite of headwinds in the last quarter, we have learned much from both our successes and setbacks, which is exactly why we are pleased to report a positive outlook for the remainder of the year. For example, our quarterly revenue has demonstrated a solid recovery from the most recent period and we've crossed major milestones in the development of our pipeline and the life cycle management of our products.

    謝謝你,約翰。大家好,早安。我很高興地向大家報告,我們在實現今天早上的新聞稿中概述的戰略目標方面取得了巨大進展。我們今年剩餘時間和 2024 年的財務和營運規劃均已掌握。儘管上個季度遇到了阻力,但我們從成功和挫折中學到了很多東西,這正是我們很高興報告今年剩餘時間的積極前景的原因。例如,我們的季度收入較最近一段時間呈現強勁復甦,我們在管道開發和產品生命週期管理方面跨越了重要里程碑。

  • With that, today's call will be quick and straight to the point as our primary goals in the near and medium term are clear and remain set. I want to remind everyone that our sites are zeroed in on advancing key objectives that drive the whole of our business forward and most importantly, to maintain a strong cash balance and discipline around long-term financial objectives. In this arena, we are laser-focused on revenue strength and improvements to our bottom line. We have and will continue to be stringent with our operating expenses so that the adjusted EBITDA profitability we have just reported is a fixture of our ongoing financial plan.

    因此,今天的電話會議將快速而直接地切入主題,因為我們近期和中期的主要目標是明確的並且仍然確定。我想提醒大家,我們的網站專注於推進推動整個業務向前發展的關鍵目標,最重要的是,圍繞長期財務目標保持強勁的現金平衡和紀律。在這個領域,我們專注於收入實力和利潤的提高。我們已經並將繼續嚴格控制我們的營運費用,以便我們剛剛報告的調整後 EBITDA 盈利能力成為我們正在進行的財務計劃的一部分。

  • This is core to our success, and I cannot emphasize it enough. We also strongly believe that our pipeline progress cannot and should not be underestimated. We are executing on the promise of extending future revenue generation of the commercial business through line extensions of our HIV products, in particular, with the FDA submission of the EGRIFTA and F8 formulation which we announced yesterday.

    這是我們成功的核心,怎麼強調都不為過。我們也堅信,我們的管道進展不能也不應被低估。我們正在履行透過 HIV 產品系列擴展來擴大商業業務未來創造收入的承諾,特別是我們昨天宣布向 FDA 提交了 EGRIFTA 和 F8 配方。

  • We are also committed to cannibalizing on the development of our lead anticancer agent, Sudocetaxel Zendusortide. As you know, we are working hard to meet Phase I clinical trial milestone timelines and report results as quickly as possible in 2024.

    我們也致力於蠶食我們的主要抗癌藥物 Sudocetaxel Zendusortide 的開發。如您所知,我們正在努力滿足 I 期臨床試驗的里程碑時間表,並在 2024 年盡快報告結果。

  • I would also like to mention a call that is very important tied to our operational planning, which is respecting our debt covenants with our lender. I am so pleased to share that we have worked together with Marathon to modify our covenants as our story progresses. These important changes include, among others, removing the increase in the liquidity covenant, which would have stepped up to $30 million, should DFA not be approved before March 31, 2024. Changing the revenue covenant to an adjusted EBITDA base covenant and changing the liquidity requirements down to $15 million over time as our adjusted EBITDA increases. These adjustments to the loan covenants can be seen as a testament to the rising confidence in our ability to execute on the company's stated goals for the year. Additionally, the new terms will allow Theratechnologies greater flexibility in our quest to deliver better profitability and even stronger financial accounts.

    我還想提一下與我們的營運規劃相關的非常重要的電話,即尊重我們與貸方的債務契約。我很高興與大家分享,隨著故事的進展,我們與 Marathon 合作修改了我們的契約。這些重要變化包括取消流動性契約的增加,如果 DFA 在 2024 年 3 月 31 日之前未獲得批准,流動性契約將增加至 3000 萬美元。將收入契約更改為調整後的 EBITDA 基本契約並更改流動性隨著我們調整後EBITDA 的增加,需求將逐漸降至1500 萬美元。這些對貸款契約的調整可以被視為我們對執行公司今年既定目標的能力信心不斷增強的證明。此外,新條款將使 Theratechnologies 在尋求提供更好的獲利能力和更強大的財務帳戶方面擁有更大的靈活性。

  • Jumping into our financial progress. In July, we announced measures to realize a $5.5 million in cost reduction for 2024. But through tight expense management, we are already seeing the impact of this measure. We're happy to report that we recorded adjusted EBITDA of $2.2 million in the third quarter. Not only was this critical milestone achieved for before the end of the fiscal year, which was promised in January, but it also marks a significant improvement quarter-over-quarter. These results put the company in a positive adjusted EBITDA range of 10% of revenues, and we are confident this figure can be improved in the coming quarters.

    進入我們的財務進展。 7 月,我們宣布了到 2024 年實現 550 萬美元成本削減的措施。但透過嚴格的費用管理,我們已經看到了該措施的影響。我們很高興地報告,第三季調整後 EBITDA 為 220 萬美元。這一重要里程碑不僅在 1 月承諾的本財年結束前實現,而且還標誌著季度環比的顯著改善。這些結果使公司的調整後 EBITDA 達到收入的 10%,我們相信這一數字在未來幾季將會改善。

  • This is the result of a significant reduction in R&D and operational expenses. And now with the completion of a number of key projects such as studies required for our FDA submission, significant expenses are behind us. This profitability gives us the agility to seek favorable terms across our strategic endeavors, even accelerating our top line. To elaborate further, our U.S. commercial capabilities are prime to scale up for bolt-on accretive products and new partnerships. Our fixed costs are also optimized, and we anticipate ongoing future leverage as we increase the intrinsic value of Theratechnologies. Additionally, we can confidently move forward with the 2024 launch plans of our approved commercial products.

    這是研發和營運費用大幅減少的結果。現在,隨著許多關鍵項目(例如我們向 FDA 提交所需的研究)的完成,我們已經擺脫了巨額開支。這種獲利能力使我們能夠靈活地在我們的策略努力中尋求有利的條件,甚至加速我們的收入成長。進一步詳細說明,我們在美國的商業能力是擴大附加加值產品和新合作夥伴關係的首要條件。我們的固定成本也得到了優化,隨著我們增加 Theratechnologies 的內在價值,我們預計未來的槓桿作用將持續存在。此外,我們可以自信地推進我們已批准的商業產品的 2024 年推出計劃。

  • Let's take a closer look at our HIV business. For fiscal year 2023, we are tightening our guidance expecting to finish the year with revenues of $82 million to $85 million. Our top line has recovered, and we report third quarter revenues of $21 million, up from a very difficult second quarter that was affected by buildup of inventory, as previously discussed.

    讓我們仔細看看我們的愛滋病毒業務。對於 2023 財年,我們正在收緊指導,預計該財年的收入將達到 8,200 萬至 8,500 萬美元。我們的收入已經恢復,我們報告的第三季收入為 2,100 萬美元,高於先前討論過的受庫存累積影響的非常困難的第二季。

  • In the third quarter, new prescription growth continued on a strong path, and we expect results to follow in Q4 of this year and into next year. Just yesterday, we announced another commercial milestones having filed the sBLA applications for the new generation of EGRIFTA SV, the F8 formulation with the FDA. In accordance with the agency's filing review period, Theratechnologies expects to receive an acknowledgment letter within 30 days, along with the PDUFA goal date. As discussed in the previous quarter, the new formulation has several improvements over prior generations including frequency of reconstitution and will immediately replace the current F4 formulation once launch.

    第三季度,新處方成長持續強勁,我們預計今年第四季和明年將出現結果。就在昨天,我們宣布了另一個商業里程碑,向 FDA 提交了新一代 EGRIFTA SV(F8 配方)的 sBLA 申請。根據該機構的備案審查期,Theratechnologies 預計將在 30 天內收到確認函以及 PDUFA 目標日期。如上一季所討論的,新配方比前幾代產品有多項改進,包括重構頻率,一旦推出將立即取代目前的 F4 配方。

  • The F8 formulation is patent protected until 2033 in the U.S. and will support revenue growth in '24 and beyond. And this is coming at the right time. In our interactions with HIV health care providers, we are seeing an increased interest in identifying and treating patients with excess visceral fat. The same momentum holds true for innovation with Trogarzo. Following completion of the intramuscular study, we are analyzing the data and are on track for a Q4 filing of an sBLA seeking approval for Trogarzo IM.

    F8 配方在美國的專利保護期至 2033 年,並將支持 24 年及以後的收入成長。這來得正是時候。在我們與愛滋病毒醫療保健提供者的互動中,我們發現人們對識別和治療內臟脂肪過多的患者越來越感興趣。 Trogarzo 的創新也具有同樣的動力。肌肉注射研究完成後,我們正在分析數據,並預計在第四季度提交 sBLA,尋求 Trogarzo IM 的批准。

  • In the meantime, we are awaiting the FDA approval for IV push instauration of the Trogarzo loading dose, a decision, which is expected in mid-December. We believe the introduction of the simplified first dose of Trogarzo by IV push followed by the eventual option for IM administration will help minimize the daily field burden for multidrug resistant patients and serve as a gateway for [nutrogarzal scripts] in combination with other injectable therapies.

    同時,我們正在等待 FDA 批准 Trogarzo 負荷劑量的靜脈注射,預計將於 12 月中旬做出決定。我們相信,透過靜脈注射引入簡化的Trogarzo 首劑,隨後選擇肌肉注射給藥,將有助於最大限度地減少多重抗藥性患者的日常現場負擔,並成為[nutrogarzal 腳本] 與其他注射療法相結合的途徑。

  • Wrapping up with oncology and where clinical trial progress is on track. You saw from the press release issued on August 30, that all 5 of the U.S.-based Sudocetaxel Zendusortide Phase I clinical trial sites have been activated to simultaneously screen, enroll and dose advanced ovarian cancer patients. A 6 site base in Canada is finalizing its start-up activity. Full details about the study design, participation criteria and contact information for the sites can be found on clinicaltrials.gov.

    總結腫瘤學以及臨床試驗進展順利。大家從8月30日發布的新聞稿中看到,美國Sudocetaxel Zendusortide一期臨床試驗點已全部啟動,同步篩選、入組和給藥晚期卵巢癌患者。加拿大的 6 個基地正在完成其啟動活動。有關研究設計、參與標準和研究中心聯繫信息的完整詳細信息,請訪問 ClinicalTrials.gov。

  • I am pleased to share that we already have a number of patients consented in actively being screened, and we look forward to announcing the first-patient dose shortly. Additionally, investments in our oncology program remains stage-gated with funding for the dosing of the 16 Phase I trial patients firmly embedded in our '23 and '24 budgets. Partnering discussions continue for the additional phases of development of Sudocetaxel Zendusortide. Looking ahead, we expect a first interim analysis or preliminary safety and efficacy data from the study by midyear 2024. Finally, our NASH asset is still in play, and we remain open to research partnerships as the environment for metabolic therapies it's opening up.

    我很高興地告訴大家,我們已經有一些患者同意積極接受篩檢,我們期待很快宣布首例患者的劑量。此外,我們對腫瘤學計畫的投資仍然是分階段進行的,為 16 名 I 期試驗患者的給藥提供的資金牢牢地納入了我們 '23 和 '24 的預算。 Sudocetaxel Zendusortide 的其他開發階段的合作討論仍在繼續。展望未來,我們預計到2024 年年中,該研究將獲得首次中期分析或初步安全性和有效性數據。最後,我們的NASH 資產仍在發揮作用,隨著代謝療法環境的開放,我們仍對研究合作夥伴關係持開放態度。

  • With this, I'd like to turn the call over to Philippe, who will be going over the period's financials in detail. Philippe?

    說到這裡,我想把電話轉給菲利普,他將詳細介紹這段期間的財務狀況。菲利普?

  • Philippe Dubuc - Senior VP & CFO

    Philippe Dubuc - Senior VP & CFO

  • Thank you, Paul, and good morning, everyone. Consolidated revenue for the 3-month period ended August 31, 2023, was $20.9 million compared to $20.8 million for the same year ago period. While revenues were flat year-over-year, this performance reflects a nice recovery from the $17.5 million in Q2, which was affected by a number of factors discussed in our Q2 call.

    謝謝你,保羅,大家早安。截至 2023 年 8 月 31 日的三個月期間的合併收入為 2,090 萬美元,而去年同期為 2,080 萬美元。雖然營收同比持平,但這一業績反映出較第二季 1,750 萬美元的良好復甦,這一數字受到我們在第二季電話會議中討論的許多因素的影響。

  • For the third quarter of fiscal 2023, net sales of EGRIFTA SV reached $13.2 million compared to $12.9 million in Q3 of last year. Higher net sales of EGRIFTA SV were a result of a higher selling price that were somewhat hampered by higher rebates to government payers. [Growing] sales of EGRIFTA SV for the first 9 months of the year stands at 2.1%, mostly the result of the negative inventory situation during our second quarter and higher rebates. Trogarzo net sales in the third quarter of fiscal 2023 amounted to $7.7 million compared to $7.9 million for the same quarter of 2022 and representing a decrease of 3.3% year-over-year. Lower sales of Trogarzo were a result of our decision to stop commercializing the product in the European territory where we recorded sales of $517,000 in the third quarter of 2022 as well as slightly lower unit sales in North America, which were offset by our higher selling price.

    2023 財年第三季度,EGRIFTA SV 的淨銷售額達到 1,320 萬美元,去年第三季為 1,290 萬美元。 EGRIFTA SV 淨銷售額的增加是由於銷售價格上漲,而政府付款人的回饋增加在一定程度上阻礙了銷售價格的上漲。今年前 9 個月,EGRIFTA SV 的銷售額成長了 2.1%,這主要是由於我們第二季的負庫存狀況和更高的折扣。 Trogarzo 2023 財年第三季的淨銷售額為 770 萬美元,而 2022 年同期為 790 萬美元,年減 3.3%。 Trogarzo 銷售額下降的原因是我們決定停止在歐洲地區商業化該產品,2022 年第三季度我們的銷售額為517,000 美元,以及北美的單位銷售額略有下降,但我們較高的售價抵消了這一影響。

  • In Q2, cost of goods sold decreased to $5 million from $5.3 million in the same quarter in fiscal 2022. The decrease in cost of goods sold was mainly due to the higher proportion of EGRIFTA SV sales which carries a higher gross margin than Trogarzo. I'm happy to report that through rigorous management of spending, R&D, selling and G&A expense were all lower this year when compared to the third quarter of 2022, helping us achieve our stated objective of becoming adjusted EBITDA positive before year-end. R&D expenses decreased by 36% in the third quarter of 2023 compared to the same period last year, mostly due to the lower spending on our oncology program, lower spending in Europe, as well as lower spending following the near completion of our life cycle management projects for both EGRIFTA SV and Trogarzo.

    第二季度,銷售成本從 2022 財年同季的 530 萬美元下降至 500 萬美元。銷售成本下降的主要原因是 EGRIFTA SV 銷售比例較高,其毛利率高於 Trogarzo。我很高興地向大家報告,透過嚴格的支出管理,與2022 年第三季相比,今年的研發、銷售和一般行政費用均較低,幫助我們實現了在年底前實現調整後EBITDA 為正值的既定目標。與去年同期相比,2023 年第三季的研發費用減少了 36%,主要是由於我們的腫瘤學專案支出減少、歐洲支出減少以及生命週期管理接近完成後支出減少EGRIFTA SV 和 Trogarzo 的專案。

  • Selling expenses decreased to $6.7 million for the third quarter of 2023 compared to $8.4 million for the same 3-month period last year or a decrease of $1.7 million. The decrease in selling expenses in the third quarter is mainly related to higher expenses incurred in the same period of 2022 related to the setting up of our internal field force in the United States, as well as severance costs incurred following our decision in 2022 to exit the European market for Trogarzo. Selling expenses should continue to stabilize as our focus on top and bottom-line growth remains our main objective for the foreseeable future, and hence, we will not be compromising on customer-facing activities.

    2023 年第三季的銷售費用減少至 670 萬美元,而去年同期為 840 萬美元,減少了 170 萬美元。第三季銷售費用減少主要與2022年同期在美國設立內部現場人員相關的費用增加以及2022年決定退出後產生的遣散費有關Trogarzo 的歐洲市場。銷售費用應繼續穩定,因為在可預見的未來,我們對營收和利潤成長的關注仍然是我們的主要目標,因此,我們不會在面向客戶的活動上做出妥協。

  • G&A expenses in the third quarter amounted to $3.7 million as compared to $4.2 million for the third quarter of 2022 or a 12% decrease. The decrease in G&A expenses is largely due to our decision to terminate the commercialization activities of Trogarzo in Europe last year, and G&A expenses are also stable compared to Q2 of this year.

    第三季的一般管理費用為 370 萬美元,而 2022 年第三季為 420 萬美元,下降了 12%。 G&A費用的減少主要是因為我們去年決定終止Trogarzo在歐洲的商業化活動,G&A費用與今年第二季相比也保持穩定。

  • As you can see from our reduction in R&D, selling and G&A expenses, we have rightsized the organization to ensure that we are well on our way in our journey towards becoming adjusted EBITDA positive. As a result of this, we are pleased to report adjusted EBITDA for the third quarter of 2023 of $2.2 million versus negative $3.9 million in the same period last year, and negative $6.1 million in the second quarter of this year. This significant improvement is due to the number of measures put in place during the year to control spending as well as lower R&D spending, reflecting the completion of many life cycle management projects.

    正如您從研發、銷售和一般行政費用的減少中看到的那樣,我們對組織進行了精簡,以確保我們在實現調整後 EBITDA 為正值的道路上順利前進。因此,我們很高興地報告 2023 年第三季調整後 EBITDA 為 220 萬美元,而去年同期為負 390 萬美元,今年第二季為負 610 萬美元。這項顯著改善是由於年內採取了許多控制支出的措施以及較低的研發支出,反映出許多生命週期管理專案的完成。

  • Net finance costs in the third quarter included interest of $2.2 million, consisting of interest on the convertible senior notes issued in June 2018 of $128,000 and interest of $2.1 million on the loan facility. These were offset by a noncash gain on the reevaluation of the warrants issued to Marathon at the beginning of this year. We ended the third quarter of fiscal 2023 with $22.9 million in cash bonds and money market funds. During the quarter, we received net proceeds of $19.7 million from the second tranche of the Marathon loan facility, and we redeemed the remaining $27.5 million of convertible debentures. And as of today, no convertible debentures remain outstanding.

    第三季的淨財務成本包括 220 萬美元的利息,其中包括 2018 年 6 月發行的可轉換優先票據的利息 128,000 美元和貸款融資的利息 210 萬美元。這些收益被今年年初重新評估向馬拉松發行的認股權證帶來的非現金收益所抵消。截至 2023 財年第三季末,我們擁有 2,290 萬美元的現金債券和貨幣市場基金。在本季度,我們從馬拉松貸款融資的第二批中獲得了 1,970 萬美元的淨收益,並贖回了剩餘的 2,750 萬美元的可轉換債券。截至今天,沒有任何未償還的可轉換債券。

  • As Paul briefly described, we agreed to modify certain covenants in the credit remains. The main change will mean that we will no longer be required to hold $30 million in cash and equivalents should the F8 formulation of EGRIFTA not be approved by the end of March 2024. As announced, we have filed the sBLA with the FDA yesterday, and this change in covenant reflects Marathon's full confidence in the timely approval of the formulation by the FDA.

    正如保羅簡要描述的那樣,我們同意修改信用遺囑中的某些契約。主要變化意味著,如果 EGRIFTA 的 F8 配方在 2024 年 3 月底前未獲得批准,我們將不再需要持有 3000 萬美元的現金和等價物。正如所宣布的,我們昨天已向 FDA 提交了 sBLA,並且這項盟約的改變體現了馬拉松公司對FDA及時批准配方的充分信心。

  • With that, Paul will be back for final comments. But first, we will now open the call to take your questions.

    屆時,保羅將回來發表最終評論。但首先,我們現在將打開電話來回答您的問題。

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from Justin Walsh with JonesTrading.

    (操作員說明)我們的第一個問題來自 JonesTrading 的 Justin Walsh。

  • Justin Howard Walsh - VP & Health Analyst

    Justin Howard Walsh - VP & Health Analyst

  • Can you provide additional color on feedback you've received from patients and physicians on the potential of EGRIFTA MDV versus EGRIFTA SV? Do you have like a sense of how you anticipate the new formulation driving sales momentum assuming that it's approved?

    您能否從患者和醫生那裡收到的有關 EGRIFTA MDV 與 EGRIFTA SV 潛力的回饋中提供更多資訊?如果新配方獲得批准,您是否知道它會如何推動銷售動能?

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Thank you, Justin, for the question. I'll turn it to John, who has hands on research on this. But obviously, if you take a look at the way this F4 formulation that we have on the market has to be reconstituted, we believe that the once-a-week reconstitution and a very small volume of injection can be beneficial for creating a better patient experience. So John, what do we have from a research point of view.

    謝謝賈斯汀的提問。我會把它交給約翰,他對此有親身研究。但顯然,如果你看看我們市場上的 F4 製劑的重構方式,我們相信每週一次的重構和極少量的注射可能有利於創造更好的患者經驗。約翰,從研究的角度來看我們有什麼?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. Justin, I think what we mainly expect is the increase in duration of therapy. We don't think it's going to be a major change and a reason to prescribe, but it's certainly much more convenient for the patients. It only has to be reconstituted once a week. It doesn't need to be refrigerated. And I think that's going to be a big help from patients, and that's what we've heard back from feedback from them already.

    是的。賈斯汀,我認為我們主要期望的是治療持續時間的增加。我們認為這不會是一個重大變化,也不會成為開處方的理由,但它對患者來說肯定要方便得多。它只需每週重新配製一次。它不需要冷藏。我認為這將為患者帶來很大的幫助,這也是我們已經從他們那裡得到的回饋。

  • Justin Howard Walsh - VP & Health Analyst

    Justin Howard Walsh - VP & Health Analyst

  • Got it. One more question for me, if I can. I believe you mentioned that it was budgeted in for this year and next. But I was wondering if you could comment on expectations for R&D spend as enrollment begins to pick up for the Phase I Sudocetaxel Zendusortide trial?

    知道了。如果可以的話,還有一個問題想問我。我相信你提到今年和明年的預算。但我想知道,隨著 I 期 Sudocetaxel Zendusortide 試驗的註冊人數開始增加,您是否可以對研發支出的預期發表評論?

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Well, as we previously said, Justin, our spending in oncology is firmly embedded. So it's about $5 million or $6 million over late of '23 and then into '24, but the pressure for reducing expenses will come simply because many of our ongoing programs in clinical development are just completed. So I stress the IM formulation. We're doing the final analysis at the moment. We will continue to have significant medical affairs supporting the business, but we expect that the R&D line as it is today in our P&L will continue to go down simply because some major programs are going away. Christian, do you want to further comment?

    好吧,正如我們之前所說,賈斯汀,我們在腫瘤學方面的支出是牢固的。因此,23 年末和 24 年大約需要 500 萬或 600 萬美元,但減少開支的壓力將會到來,因為我們正在進行的許多臨床開發項目剛剛完成。所以我強調IM配方。我們現在正在做最後的分析。我們將繼續有重要的醫療事務來支持業務,但我們預計,我們損益表中目前的研發線將繼續下降,僅僅是因為一些主要項目正在取消。克里斯蒂安,你想進一步發表評論嗎?

  • Christian Marsolais - Senior VP & Chief Medical Officer

    Christian Marsolais - Senior VP & Chief Medical Officer

  • No, that's mainly it, Justin. The IM is -- the analysis is ongoing. There won't be any activity next year. For the F8, we had some activity this year that will no longer be required next year, then that's mainly reduction at this stage.

    不,主要是這樣,賈斯汀。 IM 正在-分析正在進行中。明年不會有任何活動。對F8來說,我們今年有一些活動,明年就不再需要了,那麼現階段主要是減少。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • So Justin, we can name the IM formulation, the F8 formulation that is behind us now, the bacteriostatic water that we had to manufacture at one point, the human factor study for the F8 that was cumbersome and expensive. So there's a slew of activities that will be reduced. Now but certainly not to the point that it will compromise our ability to generate new prescriptions. The way that I see the commercial model is having a very engaged sales team but also the surround noise all around it with medical affairs and marketing activity so that we can pull the patient in. And this is what we have created. We've got great capabilities in marketing, sales and medical. And we think that this is going to make the difference again next year as we want to grow the business.

    所以賈斯汀,我們可以命名 IM 配方,現在我們身後的 F8 配方,我們曾經必須製造的抑菌水,以及繁瑣且昂貴的 F8 人為因素研究。因此,大量活動將會減少。現在,但肯定還沒有達到會損害我們開發新處方的能力的程度。我認為商業模式的方式是擁有一支非常敬業的銷售團隊,但也有圍繞醫療事務和行銷活動的噪音,這樣我們就可以吸引患者。這就是我們所創造的。我們在行銷、銷售和醫療方面擁有強大的能力。我們認為,隨著我們希望發展業務,明年這將再次產生影響。

  • Operator

    Operator

  • Our next question comes from Andre Uddin with Research Capital.

    我們的下一個問題來自 Research Capital 的 Andre Uddin。

  • Andre Uddin - MD of Healthcare Research

    Andre Uddin - MD of Healthcare Research

  • It's nice to see that your adjusted EBITDA is now positive. If we're assuming the FDA approval of the F8 formulation, if we see that, that does occur, would revenue growth primarily be driven by the F8 formulation in 2024?

    很高興看到您的調整後 EBITDA 現在為正值。如果我們假設 FDA 批准 F8 配方,如果我們看到這種情況確實發生,那麼 2024 年收入成長將主要由 F8 配方推動嗎?

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Well, I mean, I'll repeat a little bit what I said, but -- and I'll turn it to John to see if he has anything else to say, but capturing patients with the F4 is when we're asking our customer-facing people to do. And in fact, we're growing the number of NRx well over 20% compared to last year. So we are already in a good position. the F8 will certainly facilitate that, but become, I believe, a better formulation for the patient experience, thus having an impact mainly on duration of therapy. John, do you want to further comment?

    好吧,我的意思是,我會重複我所說的,但是 - 我會將其轉給約翰,看看他是否還有其他要說的,但是用 F4 捕獲患者是當我們詢問我們的面對客戶的人要做的事。事實上,與去年相比,我們的 NRx 數量增加了 20% 以上。所以我們已經處於有利位置。 F8 肯定會促進這一點,但我相信,它會成為一種更好的患者體驗配方,從而主要影響治療持續時間。約翰,你想進一步發表評論嗎?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. I mean it will certainly help and be a bit of a driver next year. The full year impact next year will not be as much as it won't be a full year of the launch. But we definitely expect it to be a driver. But as Paul said, we're continuing to see enthusiasm on the front end of enrollments, increased interest in treating excess abdominal fat. And so enrollments are very high. We're encouraged by that, and we think that's probably going to be the biggest driver moving forward.

    是的。我的意思是,它肯定會有所幫助,並在明年起到一定的推動作用。明年全年的影響不會像發布後的全年影響那麼大。但我們絕對希望它成為一個驅動程式。但正如保羅所說,我們繼續看到招生前端的熱情,以及對治療腹部多餘脂肪的興趣增加。所以入學率非常高。我們對此感到鼓舞,我們認為這可能是前進的最大推動力。

  • Andre Uddin - MD of Healthcare Research

    Andre Uddin - MD of Healthcare Research

  • Okay. And just in terms of Trogarzo intramuscular formulation, do you happen to know what the volume is that's injected? And also how often do you have to inject that formulation?

    好的。就 Trogarzo 肌肉注射製劑而言,您是否知道注射的體積是多少?您需要多久注射一次該製劑?

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Thank you, Andre. Christian, do you want to take that one?

    謝謝你,安德烈。克里斯蒂安,你想買那個嗎?

  • Christian Marsolais - Senior VP & Chief Medical Officer

    Christian Marsolais - Senior VP & Chief Medical Officer

  • Yes. Andre, the drug product is exactly the same that the patient will need to inject twice 2.3 ml, this is at the moment, what's mix for the -- in the IV push, if you want for the injection every 2 weeks. And this is -- every 2 weeks, there will be 2 injections of about 2 ml for the patient. .

    是的。安德烈,該藥品與患者需要注射兩次 2.3 毫升的藥品完全相同,這是目前的情況,如果您想每兩週注射一次,則在靜脈注射中混合。這是-每兩週,會給病人注射2次,每次約2毫升。 。

  • You have to understand that this is something which is a water-based on a clonal antibody, then it's very well tolerated by the patient. We had some two studies during the conduct of this study. and it's very well perceived and well accepted by the patients. And we think that, that will also have an impact.

    你必須明白,這是一種基於克隆抗體的水基物質,那麼患者對它的耐受性非常好。在進行這項研究期間,我們進行了兩項研究。並且深受患者的認可與接納。我們認為,這也會產生影響。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • And we believe it will be administered in pharmacies, which is not the case now for the IV push.

    我們相信它將在藥房進行管理,但現在靜脈注射的情況並非如此。

  • Christian Marsolais - Senior VP & Chief Medical Officer

    Christian Marsolais - Senior VP & Chief Medical Officer

  • Well, it will -- it could be in pharmacies, certain like -- and it will be much easier in terms of access for patients to get their injection.

    嗯,它會的——可能會在藥房,某些地方——而且患者獲得注射會更容易。

  • Operator

    Operator

  • Our next question comes from Endri Leno with National Bank.

    我們的下一個問題來自國家銀行的恩德里·萊諾。

  • Endri Leno - Analyst

    Endri Leno - Analyst

  • Congrats on the positive EBITDA. The first question I wanted to ask is that if you can talk a little bit about the mixture of the combination or the interaction rather, of volume and price for the sales of both products into fiscal Q3.

    恭喜您獲得正的 EBITDA。我想問的第一個問題是,您是否可以談談組合的混合或相互作用,即第三財季這兩種產品的銷售量和價格。

  • Philippe Dubuc - Senior VP & CFO

    Philippe Dubuc - Senior VP & CFO

  • Yes. Thank you, Endri. So as I mentioned, both volumes were pretty flat, but we did take some price increases. We gave larger rebates because of the patient mix. So all in all, for both products, stable unit numbers and a little bit of price increases. And also for Trogarzo, remember that we had some sales in Europe last year, which we didn't have this year.

    是的。謝謝你,恩德里。正如我所提到的,兩個銷量都相當持平,但我們確實進行了一些價格上漲。由於患者的混合情況,我們給予了更大的回扣。總而言之,這兩種產品的單位數量穩定,價格略有上漲。對於 Trogarzo,請記住我們去年在歐洲有一些銷售,但今年沒有。

  • Endri Leno - Analyst

    Endri Leno - Analyst

  • And just a quick follow-up on that. I mean, was there a pullback in volumes over the summer? I mean, because I think on the last update, I think volumes were growing 27% for EGRIFTA and 8% or 9% for Trogarzo or something along those lines.

    對此進行快速跟進。我的意思是,夏季銷量是否有所下降?我的意思是,因為我認為在上次更新中,EGRIFTA 的交易量增加了 27%,Trogarzo 或類似的交易量增加了 8% 或 9%。

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. So what we're seeing is, as I said, is correct that the -- on the front end, we're seeing increased interest in treatment. We're seeing a lot of new patients coming in double-digit growth of new enrollments. But we did see early in the year a little bit of a churn in the patient base in refills. And that's since corrected and has been on an upswing since Q2 and now is above where it was. So we are seeing overall growth of the total patient base above where it was last year, but it's not as much as we would expect with the enrollment -- increase in enrollment due to this period early in the year where we had this churn of the patient base.

    是的。因此,正如我所說,我們所看到的是正確的——在前端,我們看到人們對治療的興趣增加。我們看到許多新病患的新入院人數呈現兩位數成長。但我們在今年年初確實看到續藥患者族群出現了一些流失。自第二季以來,這一數字已經得到糾正,並且一直在上升,現在已經高於原來的水平。因此,我們看到患者總數的整體成長高於去年,但入組人數並沒有我們預期的那麼多——入組人數的增加是由於今年年初的這段時期,我們在這段時間出現了患者的流失。患者基礎。

  • Endri Leno - Analyst

    Endri Leno - Analyst

  • Okay. And yes, one more question. Just -- this is more a little bit looking into Q4 because the implied Q4 revenue, I mean, seems pretty strong sequentially and year-over-year. I'm assuming that is mostly volume from the interest you're seeing. Or do you have any price increase embedded on that one? I mean in addition to what you've already done.

    好的。是的,還有一個問題。只是 - 這更多的是對第四季度的研究,因為我的意思是,隱含的第四季度收入似乎連續和同比都相當強勁。我假設這主要是您所看到的興趣的數量。或者你們是否有任何價格上漲?我的意思是除了你已經做過的事情之外。

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes, that will mainly be volume. We don't have any pricing increase planned in Q4.

    是的,這主要是數量。我們沒有計劃在第四季度提高任何價格。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Yes. And traditionally, this is the pattern that we've seen before. Q4 has always been very strong. And obviously, we're counting on this. And following the issue that we had in the second quarter regarding inventory buildup, we are extremely, extremely focused on inventory at hand at the pharmacy level. So we control what's happening. And we have all the reasons to believe that the Q4 is going to unfold the way we've seen it in the previous years. And that we should actually complete 2023 within the guidance that I've just given today. So we're confident based on the way we're capturing new patients and the way that they are converted into getting the scripts and getting on the medicines that we will get there. And it's going to pave the way for a good 2024 because don't forget that our performance this year has been set back significantly by the second quarter and the inventory situation that we've described. So if you take that away, our run rate now is significantly over $82 million.

    是的。傳統上,這是我們以前見過的模式。 Q4一直很強。顯然,我們指望這一點。在第二季出現有關庫存累積的問題之後,我們非常非常關注藥房層級的現有庫存。所以我們可以控制正在發生的事情。我們有充分的理由相信第四季將會像我們前幾年看到的那樣展開。我們實際上應該在我今天剛剛給出的指導下完成 2023 年的任務。因此,基於我們吸引新患者的方式以及將他們轉化為獲取腳本和使用我們將到達的藥物的方式,我們充滿信心。這將為 2024 年的美好業績鋪平道路,因為不要忘記,我們今年的業績因第二季和我們所描述的庫存狀況而大幅下滑。因此,如果去掉這一點,我們現在的運行費用明顯超過 8,200 萬美元。

  • Endri Leno - Analyst

    Endri Leno - Analyst

  • That's great to hear. And one last one for me. You mentioned in the opening remarks, Paul, of still continuing to look to expand the commercial portfolio. Can you talk a little bit about the quality, the type of assets that you're seeing out there and your multiples? And any color you can share on that regard.

    聽到這個消息我很高興。最後一張是給我的。保羅,您在開場白中提到仍在繼續尋求擴大商業投資組合。您能談談您所看到的資產的品質、類型以及您的本益比嗎?您可以分享這方面的任何顏色。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Yes. So we said before that it could be in HIV. We have obviously capabilities, and we're calling on roughly 2,800 HIV providers in the U.S. and they treat the bulk of the HIV patients. We also said that it could be an HIV adjacent type of business. So something that is not necessarily a specific HIV therapies but a therapy that HIV patients are using. And looking at the capabilities that we've built in the field and in my management team and in training and all other aspects of our go-to-market model, we could take on small metabolic. Small metabolic is very similar to a rare disease type. And in fact, the business that we have is very much like rare disease because we're calling on very few health care providers, but at the same time, we've got products that are using niche and they are reimbursed at a high price because they provide high value. So this is very much like a rare disease.

    是的。所以我們之前說過它可能是愛滋病毒。我們顯然有能力,我們正在向美國大約 2,800 名愛滋病毒提供者求助,他們治療了大部分愛滋病毒患者。我們也說過,這可能是一種與愛滋病相關的業務類型。因此,這不一定是特定的愛滋病毒療法,而是愛滋病毒患者正在使用的療法。看看我們在現場、管理團隊、培訓和進入市場模式的所有其他方面建立的能力,我們可以進行小型新陳代謝。小代謝與罕見疾病類型非常相似。事實上,我們的業務非常類似於罕見疾病,因為我們只需要很少的醫療保健提供者,但同時,我們擁有利用利基市場的產品,並且它們的報銷價格很高因為它們提供了高價值。所以這很像一種罕見疾病。

  • So there are some rare disease products that could actually very much fit our model. where we could have to actually build another sales team. But providing that the product is deprioritized by big pharma or already on the market, it would drive already some accretive sales and bottom line. And therefore, we would not hesitate for the right agent to build another field force because we do have the infrastructure in sales, marketing, medical and the back office to take on bolt-on initiatives.

    因此,有一些罕見疾病產品實際上非常適合我們的模型。我們可能必須真正建立另一個銷售團隊。但如果該產品不被大型製藥公司優先考慮或已經上市,它就會推動一些銷售和利潤的成長。因此,我們會毫不猶豫地尋找合適的代理商來建立另一支現場隊伍,因為我們確實擁有銷售、行銷、醫療和後台方面的基礎設施來採取補充計劃。

  • And that is why we're so happy now that we were able to renegotiate some of the covenants with Marathon, we've got a clean deck moving forward. And we think that we could providing that we put our hands on the right asset, accelerate our journey towards profitability by looking for bolt-on acquisition type. Have I answered your question?

    這就是為什麼我們現在如此高興,因為我們能夠與馬拉松重新談判一些契約,我們已經有了一個乾淨的前進方向。我們認為,我們可以提供正確的資產,透過尋找補強收購類型來加速我們的獲利之旅。我回答你的問題了嗎?

  • Endri Leno - Analyst

    Endri Leno - Analyst

  • Yes, mostly. Just one quick follow-up. Is that, in terms -- have you seen any changes, let's say, over the last year in terms of the multiple or IRRs or however it is that you value this bolt-on assets.

    是的,大部分是。只需一個快速跟進。就而言,您是否看到了去年在倍數或內部收益率方面的任何變化,或者您對這種附加資產的重視程度。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Philippe, do you want to comment?

    菲利普,你想發表評論嗎?

  • Philippe Dubuc - Senior VP & CFO

    Philippe Dubuc - Senior VP & CFO

  • No. And actually, the products we're going after aren't really in auctions or we kind of dig through big pharma, their portfolio and we reach out. So we're not really in competition with anyone else.

    不。實際上,我們要尋找的產品並沒有真正在拍賣中,或者我們透過大型製藥公司及其產品組合進行挖掘,然後我們進行接觸。所以我們並沒有真正與其他人競爭。

  • Operator

    Operator

  • (Operator Instructions) Our next question comes from Will Maughan with Canaccord.

    (操作員說明)我們的下一個問題來自 Canaccord 的 Will Maughan。

  • Unidentified Analyst

    Unidentified Analyst

  • This is [Kathleen] on for Will. On the oncology Phase I trial with the update coming now in mid-2024, what can we expect in terms of patient numbers there? Another way of asking the question, do you expect the data at that point to address the taxane in the prior study? And how much is that gating partnership interest.

    這是威爾的[凱瑟琳]。腫瘤學 I 期試驗將於 2024 年中期進行更新,我們對患者數量有何預期?另一種提問方式是,您是否期望此時的數據能夠解決先前研究中的紫杉烷問題?以及控制合夥人利益的程度是多少。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • So Christian, you may want to talk about the expectation, and I can address a partnership.

    所以克里斯蒂安,你可能想談談期望,我可以談談合作關係。

  • Christian Marsolais - Senior VP & Chief Medical Officer

    Christian Marsolais - Senior VP & Chief Medical Officer

  • Yes, absolutely. The -- as Paul mentioned before, the 5 sites in the U.S. are recruiting patients at the moment. There are a number of patients in screening, then we're expecting to complete the first quarter of patients. What we have in the protocol, there is a court of 6 patients, the first dose, which is 1.75 milligram per kg every week for 3 weeks and a week break. After those 6 patients will be initiated on treatment, we wait 3 months to look at the adverse event profile, and we'll restart after that based on a good safety profile.

    是的,一點沒錯。正如 Paul 之前提到的,美國的 5 個站點目前正在招募患者。有許多患者正在篩檢中,我們預計將完成第一季的患者篩檢。在我們的方案中,有 6 位患者,第一劑是每週每公斤 1.75 毫克,持續 3 週,休息一週。這 6 名患者開始接受治療後,我們會等待 3 個月來查看不良事件概況,之後我們將根據良好的安全概況重新開始治療。

  • Six other patients at 2.5 milligram per kilogram every week. And with those 12 patients, I think that we will have a very good sign, if there are signs of efficacy by mid next year. After the 6 patients at the higher dose, the FDA also wanted us to include another 4 patients for a total of 10 patients in this cohort 2.5 milligram. Then total, it will be 16 patients, but as we go based on the data that we have seen so far based on the disease stabilization that we have seen in a number of patients, we think that we will have clear signs of efficacy by middle of the year.

    其他 6 名患者每週服用 2.5 毫克/公斤。對於這 12 名患者,我認為如果到明年中期出現療效跡象,我們將看到一個非常好的跡象。在 6 名患者接受較高劑量後,FDA 也希望我們再納入另外 4 名患者,使該隊列中總共 10 名患者接受 2.5 毫克劑量。那麼總共將有 16 名患者,但根據我們迄今為止在許多患者中看到的疾病穩定情況所看到的數據,我們認為到中期我們將有明顯的療效跡象。今年的。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • So from a partnership point of view, I said before, and it's still true. We have many companies at the table very interested by our TH1902, but also the platform or the technology we have. However, at this stage of the game, we're only months away from having additional clinical efficacy in humans to report. And a lot of companies will want to actually wait until they see the back-to-back efficacy data that we think we're going to have. Keep in mind that we've already released a lot of information at ACR, but also at ASCO that shows that we actually had clinical benefits in many patients but now that we have a tighter protocol, we believe that in ovarian cancer, we're going to strike more often and be able to move on to the next phases of development.

    所以從合作夥伴的角度來看,我之前說過,現在仍然如此。桌上有很多公司對我們的 TH1902 以及我們擁有的平台或技術非常感興趣。然而,在目前的階段,我們距離獲得額外的人體臨床療效報告只有幾個月的時間了。許多公司希望真正等到他們看到我們認為我們將獲得的連續功效數據。請記住,我們已經在 ACR 和 ASCO 上發布了很多信息,這些信息表明我們實際上對許多患者俱有臨床益處,但現在我們有了更嚴格的方案,我們相信在卵巢癌中,我們將更頻繁地罷工並能夠進入下一階段的發展。

  • But what I can say in addition to that is that our platform is being noticed, and we see a great deal of interest for partnership activities at the labs because people actually see what our receptor does and by contributing some technologies to our peptide, they would have access to the cancer cells in a more efficient manner just like our TH1902 is getting into the cancer cells more effectively.

    但除此之外我還能說的是,我們的平台正在受到關注,我們看到對實驗室合作活動的極大興趣,因為人們實際上看到了我們的受體的作用,並且透過為我們的勝肽貢獻一些技術,他們會以更有效的方式進入癌細胞,就像我們的TH1902更有效地進入癌細胞一樣。

  • So there's lots developing on oncology. And that's why I think that while we're focusing on turning the organization profitable and first EBITDA positive, we don't want to abandon the screen card that we have in oncology. We just want to stage gate the spending, which is exactly what we're doing at the moment. And we believe that the next phases of development, whether at the labs or whether in the clinic, will come through partnerships. And as I said, we have many oncology companies that have seen what we have reported, and I feel very optimistic for the future.

    因此,腫瘤學方面有許多發展。這就是為什麼我認為,雖然我們專注於使組織盈利並首先實現 EBITDA 為正值,但我們不想放棄我們在腫瘤學方面的篩選卡。我們只是想控制支出,這正是我們目前正在做的事情。我們相信,下一階段的開發,無論是在實驗室還是在診所,都將透過合作夥伴關係來實現。正如我所說,我們有許多腫瘤學公司已經看到了我們所報告的情況,我對未來感到非常樂觀。

  • Operator

    Operator

  • This concludes our question-and-answer session. I would like to turn the conference back over to Paul Lévesque for any closing remarks.

    我們的問答環節到此結束。我想將會議轉回保羅·勒維克(Paul Lévesque)發表閉幕詞。

  • Philippe Dubuc - Senior VP & CFO

    Philippe Dubuc - Senior VP & CFO

  • Well, there's a few questions that came in on the webcast. So most of them are related to the 1902 trial and relating to the timing. Are we seeing patients coming in soon. What's the -- has there been more delays than what we expected? And what's our thoughts on enrollment.

    嗯,網路廣播中提出了一些問題。所以大部分都跟1902年的審判有關,跟時間有關。我們是否很快就會看到病人進來?這是怎麼回事——延誤時間是否比我們預期的還要多?我們對招生有何想法?

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Christian, do you want to clarify?

    克里斯蒂安,你想澄清一下嗎?

  • Christian Marsolais - Senior VP & Chief Medical Officer

    Christian Marsolais - Senior VP & Chief Medical Officer

  • This is more or less what we were expecting. But as we had announced, one of the change like some of the changes of the protocol were really the selection of basin. Then what we're doing in that study is that we're selecting patients that have less taxane prior exposure. It will be a maximum of one failure on taxane and a lower number of prior treatments. Therefore, the selection of patients is a bit more difficult than what we had in the past. But we do believe that this is the best way to move forward in order to show efficacy with this trial.

    這或多或少是我們所期待的。但正如我們所宣布的,像協議的一些變化一樣,變化之一實際上是盆地的選擇。然後我們在該研究中所做的就是選擇先前接觸紫杉烷較少的患者。紫杉烷類藥物最多會失敗一次,而之前的治療次數也會減少。所以,患者的選擇比我們過去困難一些。但我們確實相信,這是前進的最佳方式,以顯示該試驗的有效性。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Yes. And do not forget that all the patients can be recruited at the same time. It's not one patient at a time. The sites are now activated we could have patients enroll in dosed at the same time. So once the ball gets rolling, it could accelerate very nicely.

    是的。並且不要忘記,可以同時招募所有患者。這不是一次只處理一個病人。這些網站現已激活,我們可以讓患者同時報名參加服藥。因此,一旦球開始滾動,它就可以很好地加速。

  • Philippe Dubuc - Senior VP & CFO

    Philippe Dubuc - Senior VP & CFO

  • Absolutely, yes. And last question on the status of discussions with our auditors regarding the going concern opinion in view of the Marathon changes. Well, it's a little bit early to have discussions. But obviously, we had some -- they are aware of the changes, and it was viewed very favorably with auditors and the audit committee yesterday. So we'll see come November what's the status will be. And that's it for questions, Paul.

    絕對沒錯。最後一個問題是關於馬拉松變化後與我們的審計師就持續經營意見進行討論的情況。嗯,現在討論還為時過早。但顯然,我們有一些——他們知道這些變化,昨天審計師和審計委員會對此非常有利。所以我們將在 11 月看看情況如何。保羅,問題就到此為止。

  • Paul Lévesque - President, CEO & Director

    Paul Lévesque - President, CEO & Director

  • Thank you, everyone, for attending the call today. As discussed, we have made great progress towards achieving all of our goals for the year. Today's Q3 results demonstrate that we have turned a corner for Q4 and beyond, and there will be no turning back. With the submission of the F8 formulation to the FDA achieving adjusted EBITDA profitability ahead of schedule, our significant reduction in operating expenses and the increasing confidence entrusted to us by Marathon, we are enabling long-term value creation for the investors who are with us on this road to growth and ongoing profitability. Theratechnologies is determined to maintain this upward trajectory.

    謝謝大家今天參加電話會議。正如所討論的,我們在實現今年的所有目標方面取得了巨大進展。今天的第三季業績表明,我們已經在第四季及以後扭轉了局面,並且不會再有回頭路。隨著 F8 配方提前向 FDA 提交,實現了調整後的 EBITDA 盈利能力、我們營運費用的顯著降低以及 Marathon 賦予我們的信心不斷增強,我們正在為與我們一起的投資者創造長期價值。這條通往成長和持續獲利的道路。 Theratenologies 決心維持這種上升軌跡。

  • Thank you again, and see you soon on the Q4 call and at the upcoming commercial, medical and investor meetings. Have a great day.

    再次感謝您,我們很快就會在第四季度電話會議以及即將舉行的商業、醫療和投資者會議上見到您。祝你有美好的一天。

  • Operator

    Operator

  • The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

    會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。