Theratechnologies Inc (THTX) 2025 Q1 法說會逐字稿

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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 morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies first-quarter 2025 earnings call. We would like to remind everyone that all figures on this call are quoted in US dollars.

    女士們、先生們,早安,謝謝你們的支持。歡迎參加 Theratechnologies 2025 年第一季財報電話會議。我們想提醒大家,本次電話會議中的所有數字均以美元報價。

  • (Operator Instructions) I would like to remind everyone that this conference call is being recorded today, Wednesday, April 9, 2025, at 8:30 AM Eastern Time.

    (操作員指示)我想提醒大家,本次電話會議將於今天,即 2025 年 4 月 9 日星期三,東部時間上午 8:30 進行錄音。

  • I will now turn the call over to Joanne Choi, Senior Director, Investor Relations at Theratechnologies. Joanne, please go ahead.

    現在我將電話轉給 Theratechnologies 投資人關係資深總監 Joanne Choi。喬安妮,請繼續。

  • Joanne Choi - Senior Director, Investor Relations

    Joanne Choi - Senior Director, Investor Relations

  • Thank you, Drew. Good morning and thank you for joining Theratechnologies First Quarter 2025 Earnings Call. On today's call, we are joined by Paul Lévesque, Theratechnologies' President and Chief Executive Officer; and Philippe Dubuc, Senior Vice President and Chief Financial Officer. After the prepared remarks, we will open up the call for your questions, where we will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer; and John Leasure, the company's Global Commercial Officer.

    謝謝你,德魯。早安,感謝您參加 Theratechnologies 2025 年第一季財報電話會議。在今天的電話會議上,我們邀請了 Theratechnologies 總裁兼執行長 Paul Lévesque;以及資深副總裁兼財務長 Philippe Dubuc。準備好的演講結束後,我們將開始回答大家的提問,高級副總裁兼首席醫療官 Christian Marsolais 博士將與我們一起提問;以及該公司全球商務官 John Leasure。

  • Before we begin, I'd like to remind everyone that today's remarks contain forward-looking statements within the meaning of securities laws, including our business and financial outlook. Actual results may differ materially from historical performance and those forward-looking statements implied herein.

    在我們開始之前,我想提醒大家,今天的言論包含證券法意義上的前瞻性陳述,包括我們的業務和財務展望。實際結果可能與歷史表現和本文暗示的前瞻性陳述有重大差異。

  • These statements, together with the assumptions underlying them and the risks related thereto, are outlined in detail in the forward-looking information section of Theratechnologies' MD&A issued this morning and available on SEDAR+ and on EDGAR. Forward-looking statements represent Theratechnologies' expectations as of this morning, April 9, 2025.

    這些聲明以及背後的假設和相關風險均在 Theratechnologies 今早發布的 MD&A 的前瞻性資訊部分中有詳細概述,可在 SEDAR+ 和 EDGAR 上查閱。前瞻性陳述代表了 Theratechnologies 截至 2025 年 4 月 9 日上午的預期。

  • Additionally, the company is using the term adjusted EBITDA, which is not a financial measure under IFRS or US generally accepted accounting principles, US GAAP. Adjusted EBITDA excludes the effects of items that primarily reflect the impact of long-term investment and financing decisions rather than the results of day-to-day operations. Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another.

    此外,該公司使用的術語「調整後 EBITDA」並不是 IFRS 或美國公認會計原則 US GAAP 下的財務指標。調整後的 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 認為,這項指標可以作為衡量其不同時期營運績效和財務狀況的有用指標。

  • 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 as well as on SEDAR+ and EDGAR, as mentioned earlier.

    該公司使用此非國際財務報告準則衡量指標來做出財務、策略和營運決策。如前所述,我們今天早上發布的 MD&A 以及 SEDAR+ 和 EDGAR 中都列出了調整後的 EBITDA 與淨虧損的對帳。

  • Thank you. I will now turn the conference over to our CEO. Paul?

    謝謝。現在我將會議交給我們的執行長。保羅?

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Thank you, Joanne, and good morning, everyone. I'm pleased to report on our fiscal first quarter ending February 28 with total revenues of $19 million, representing 17% growth from the same period last year. The strong performance on a relative basis was driven by the strength of our lead asset, EGRIFTA SV, which continues to carry the best momentum we have seen since its market introduction.

    謝謝你,喬安妮,大家早安。我很高興地報告,截至 2 月 28 日的第一財季,我們的總收入為 1900 萬美元,比去年同期增長 17%。相對強勁的表現得益於我們的主要資產 EGRIFTA SV 的強勁表​​現,該資產自上市以來一直保持著最佳發展勢頭。

  • There are two main reasons for this. First, excess visceral abdominal fat, or EVAF, is increasingly being recognized by the medical community as a potentially serious condition requiring attention and treatment. There's also strong supporting evidence linking EVAF with increased cardiovascular risk and metabolic disease, which I will expand upon a bit more on the call shortly. This, coupled with our specialized field force focused on community education and product differentiation, has truly been the driving force behind this uptake.

    主要有兩個原因。首先,醫學界越來越多地認識到內臟腹部脂肪過多(EVAF)是一種需要關注和治療的潛在嚴重疾病。還有強有力的證據表明 EVAF 與心血管風險和代謝疾病的增加有關,我將在稍後的電話會議上對此進行更詳細的說明。這一點,加上我們專注於社區教育和產品差異化的專業領域力量,真正成為了這一成長背後的推動力。

  • This brings me to the recent approval of our F8 formulation of tesamorelin. We are absolutely thrilled to be bringing this new and improved formulation to the market, where it will continue to remain our engine of growth for years to come. EGRIFTA WR comes with a host of new benefits for patients.

    這讓我想到我們最近批准的 F8 配方 tesamorelin。我們非常高興能夠將這種全新改良的配方推向市場,它將在未來幾年繼續成為我們的成長引擎。EGRIFTA WR 為患者帶來了一系列新益處。

  • To start, this new formulation only requires a once-weekly reconstitution as opposed to daily, which is a material enhancement designed with patients in mind for a simpler and less cumbersome administration. The F8 formulation requires a smaller volume of administration and comes with a smaller syringe and needle than the current F4 formulation.

    首先,這種新配方只需要每週配製一次,而不是每天配製一次,這是一種專為患者設計的物質增強,旨在實現更簡單、更輕鬆的給藥方式。與目前的 F4 配方相比,F8 配方所需的給藥量較小,且配備的注射器和針頭也較小。

  • And finally, in developing this new formulation, we conducted a very thorough human factor study. This substantial investment resulted in crystal clear instruction for use for the patient. We are very confident that this new and improved formulation will lead to better patient experience, adherence and duration of treatment.

    最後,在開發這種新配方時,我們進行了非常徹底的人為因素研究。這項巨大的投資為患者帶來了清晰的使用指導。我們非常有信心,這種新的改進配方將帶來更好的患者體驗、依從性和治療持續時間。

  • As you recall, we resumed distribution of EGRIFTA SV in mid-February following a temporary drug shortage that began in early January, which resulted in a sales loss of six to seven weeks. Fortunately, new and returning patients were able to fill their scripts within one or two weeks after supply was restored, and we are now fully back in business. With March patient data in, we're happy to report that our total number of unique patients is up year-over-year, indicating the base of patients is back on treatment.

    大家還記得,在 1 月初出現暫時性藥品短缺,導致銷售損失六至七週之後,我們於 2 月中旬恢復了 EGRIFTA SV 的分銷。幸運的是,新病人和回頭客能夠在供應恢復後一到兩週內配藥,現在我們已完全恢復營業。根據三月患者數據,我們很高興地報告,我們的獨立患者總數同比增長,表明患者群體已恢復接受治療。

  • In addition, new enrollments were up 15% in the first quarter compared to last year. This speaks to the dedication and performance of our field force who were able to successfully market the benefits of EGRIFTA SV through that unfortunate period. Our teams are working hard to orchestrate a successful launch and effective transition from the F4 to the F8, which will be available in pharmacies beginning in July.

    此外,第一季新生入學人數與去年同期相比增加了15%。這證明了我們的外勤人員的奉獻精神和出色的表現,他們能夠在那段不幸的時期成功地推銷 EGRIFTA SV 的優勢。我們的團隊正在努力協調 F4 到 F8 的成功發布和有效過渡,F8 將於 7 月開始在藥局發售。

  • Importantly, this week's approval of the prior approval supplement lifts any remaining uncertainty regarding supply. With ample SV on the market and additional batches in production and ready for shipment, we look forward to a seamless transition from EGRIFTA SV to EGRIFTA WR to be completed in early 2026.

    重要的是,本週批准的補充批准消除了有關供應的任何剩餘不確定性。由於市場上有充足的 SV,並且有更多批次正在生產並準備發貨,我們期待在 2026 年初完成從 EGRIFTA SV 到 EGRIFTA WR 的無縫過渡。

  • To further develop the strength of our HIV business, we recently presented data from the PROMISE-US and VAMOS studies at CROI in March. The first poster featured data from the real-world observational registry, PROMISE-US, demonstrating the efficacy and safety of ibalizumab in reducing HIV to undetectable levels in heavily treatment-experienced patients with multidrug resistant situation.

    為了進一步增強我們的 HIV 業務實力,我們最近在 3 月的 CROI 上展示了 PROMISE-US 和 VAMOS 研究的數據。第一張海報展示了來自真實世界觀察性註冊中心 PROMISE-US 的數據,證明了伊巴利珠單抗在將接受過大量治療且具有多重抗藥性情況的 HIV 患者體內的 HIV 降低至無法檢測的水平方面的有效性和安全性。

  • Researchers presented an interim unmatched subgroup analysis comprising 112 participants. Results showed impressive reduction in viremia in patients whose regimens include ibalizumab despite having lower CD counts and higher viral loads at baseline than the non-ibalizumab control group. Ibalizumab was well tolerated with no infusion reaction and treatment-emergent adverse events.

    研究人員公佈了一項包含 112 名參與者的中期未匹配亞組分析。研究結果顯示,與非伊巴利珠單抗對照組相比,接受伊巴利珠單抗治療的患者的基線 CD 數較低且病毒量較高,但其病毒血症明顯減少。伊巴利珠單抗耐受性良好,沒有輸液反應和治療引起的不良事件。

  • Despite the advent of new therapies, multidrug resistance has persisted. As a result, there continues to be a need to establish and maintain virologic control, especially for people who are heavily treatment experienced. These latest data suggest that ibalizumab is an indispensable agent for hard-to-treat patients and will continue to be used in combination with other long-acting injectables. We look forward to continuing to enroll patients in this first-of-its-kind registry.

    儘管出現了新的治療方法,但多重抗藥性仍然存在。因此,仍然需要建立和維持病毒學控制,特別是對於接受過大量治療的人。這些最新數據表明,ibalizumab 是難治性患者不可或缺的藥物,並將繼續與其他長效注射劑合併使用。我們期待繼續在這個首創的登記處招募病患。

  • In the second poster, researchers from the Visceral Adiposity Measurement and Observation Study, or VAMOS, demonstrated that EVAF drives cardiovascular risk in patients with HIV. Investigators presented data highlighting the limitations of using BMI alone in assessing CV risk, particularly given the high CV risk observed in study participants with a normal or low BMI but high levels of EVAF.

    在第二張海報中,內臟脂肪測量和觀察研究 (VAMOS) 的研究人員證明,EVAF 會增加 HIV 患者的心血管風險。研究人員提供的數據強調了單獨使用 BMI 評估心血管風險的局限性,特別是考慮到研究參與者中 BMI 正常或較低但 EVAF 水平高的人心血管風險較高。

  • Traditionally, clinicians have used BMI as a marker to assess the risk of cardiovascular disease and other comorbidities in this population, but have often overlooked the importance of EVAF. These findings underscore that if health care providers focus solely on BMI, a sizable population of normal weight and overweight individuals with HIV, EVAF and high CV risk will be missed.

    傳統上,臨床醫生使用 BMI 作為指標來評估該族群心血管疾病和其他合併症的風險,但往往忽略了 EVAF 的重要性。這些發現強調,如果醫療保健提供者僅僅關注 BMI,那麼大量患有 HIV、EVAF 和高 CV 風險的正常體重和超重個體將會被忽視。

  • We hope this study encourages the use of simple and more precise tools for assessing EVAF, such as measuring waist circumference as a proven means to identifying people with HIV who are at risk of cardiovascular disease.

    我們希望這項研究能鼓勵使用簡單、更精確的工具來評估 EVAF,例如測量腰圍作為識別有心血管疾病風險的 HIV 感染者的有效方法。

  • Shifting over to business development. I want to start by sharing our approach to capital allocation in light of our new business strategy. With the drug shortage now behind us, our HIV business remains strong from a demand perspective, and we're now on the brink of generating meaningful cash flow supported by our new operating structure.

    轉向業務發展。首先,我想根據我們的新業務策略分享我們的資本配置方法。隨著藥品短缺問題的解決,從需求角度來看,我們的愛滋病毒業務依然強勁,而且在新的營運結構支持下,我們即將產生有意義的現金流。

  • When thinking about long-term value creation, we made the strategic decision to commit ourselves to increasing the bottom line of this organization. This means that we will remain prudent in our spend to execute on the planned expansion of our portfolio through acquisitions and in-licensing of late-stage products.

    在考慮長期價值創造時,我們做出了策略決策,致力於提高組織的底線。這意味著我們將保持謹慎的支出,透過收購和後期產品授權來執行我們產品組合的計畫擴張。

  • Central to our philosophy is to invest in the opportunities that offer the highest return on investment. This is why we are prioritizing products where we will have the ability to derive meaningful synergies from our current infrastructure so that our top line will continue to outpace our expenses. In conjunction, we continue to make progress with the launches of olezarsen and donidalorsen in Canada with preparations for filing to be submitted later this year.

    我們的理念核心是投資能帶來最高投資回報的機會。這就是為什麼我們優先考慮那些能夠從我們現有的基礎設施中獲得有意義的協同效應的產品,以便我們的收入可以繼續超過我們的支出。同時,我們在加拿大推出 olezarsen 和 donidalorsen 的進程中繼續取得進展,並準備在今年稍後提交申請。

  • Finally, on oncology, we continue to engage with potential partners. Oncology is all about discovering new targets, particularly in advanced cancers. Our SORT1 platform is, in of itself, an innovative technology that can have applications in many cancer treatments in the future. We will update you as development takes place.

    最後,在腫瘤學方面,我們繼續與潛在的合作夥伴合作。腫瘤學就是要發現新的標靶,特別是晚期癌症。我們的 SORT1 平臺本身就是一項創新技術,未來可應用於多種癌症治療。隨著開發進展,我們將向您通報最新進展。

  • Before handing over the call to Philippe to review our first quarter performance in more detail, I would like to close with a few words on tariffs. We've been closely following the situation with tariffs and have mapped out our supply chains, particularly for EGRIFTA SV, which is pretty straightforward.

    在將電話交給菲利普來更詳細地回顧我們第一季的業績之前,我想最後先談幾句關於關稅的問題。我們一直在密切關注關稅情況,並規劃了我們的供應鏈,特別是針對 EGRIFTA SV,這非常簡單。

  • While we cannot avoid any impact entirely as our manufacturing process currently takes place both in the US and Canada, we do not expect to be significantly impacted by tariffs should they be enforced. And with the approval of the F8 formulation, we will soon be moving 100% of our manufacturing to a new CDMO based in the US.

    由於我們的製造過程目前在美國和加拿大進行,我們無法完全避免任何影響,但如果關稅實施,我們預計不會受到重大影響。隨著 F8 配方的批准,我們很快就會把 100% 的生產轉移到位於美國的新 CDMO。

  • With that, I will now turn over to Philippe to review our first quarter performance.

    現在,我將交給菲利普來回顧我們第一季的業績。

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • Thank you, Paul. Good morning, everyone. I am pleased to report that even though the EGRIFTA SV shortage had an impact on our financial results for the first quarter of 2025, we managed to finish the three-month period with $19 million in revenues and growth of 17% and a positive adjusted EBITDA of $2.3 million versus an adjusted EBITDA loss of $247,000 last year. This brings our last 12 months' adjusted EBITDA figure to $22.7 million on LTM sales of approximately $89 million or a margin of over 25%.

    謝謝你,保羅。大家早安。我很高興地報告,儘管 EGRIFTA SV 短缺對我們 2025 年第一季的財務業績產生了影響,但我們仍成功完成了三個月的營收 1900 萬美元、成長率 17% 以及調整後 EBITDA 為正 230 萬美元,而去年調整後 EBITDA 虧損 247,000 美元。這使得我們過去 12 個月的調整後 EBITDA 數字達到 2,270 萬美元,LTM 銷售額約為 8,900 萬美元,利潤率超過 25%。

  • I will caution, however, that this performance is in part due to a few large orders for EGRIFTA SV at the end of the quarter to rebuild inventories at McKesson and in our specialty pharmacy network, with some pharmacies ordering larger-than-usual quantities, which will result in a longer drawdown than usual. This should have an impact on Q2 revenues, and this is why we are providing guidance this morning of $80 million to $83 million in revenues for 2025 along with an adjusted EBITDA of $10 million to $12 million.

    不過,我要提醒的是,這種表現部分是由於本季度末對 EGRIFTA SV 的幾筆大額訂單,用於重建 McKesson 和我們的專業藥房網絡的庫存,其中一些藥房的訂購數量比平時要大,這將導致比平時更長的提貨時間。這應該會對第二季的營收產生影響,這就是為什麼我們今天早上提供的指引是 2025 年的營收為 8,000 萬至 8,300 萬美元,調整後的 EBITDA 為 1,000 萬至 1,200 萬美元。

  • We estimate that we lost up to six or seven weeks of unit sales due to the shortage, which translates into approximately $10 million in revenue. We also believe the shortage could have a small impact on our patient base, which could have an additional $1 million to $2 million impact on sales this year.

    我們估計,由於短缺,我們損失了多達六到七週的單位銷售量,相當於約 1000 萬美元的收入。我們也認為,短缺可能會對我們的患者群體產生輕微影響,但可能會對今年的銷售額造成 100 萬至 200 萬美元的額外影響。

  • For the first quarter of fiscal 2025, net sales of EGRIFTA SV reached $13.9 million compared to $9.6 million in Q1 of last year, which represents a 45% increase year over year. Recall that Q1 2024 sales of EGRIFTA SV were impacted by inventory drawdowns at the specialty pharmacy level.

    2025財年第一季,EGRIFTA SV的淨銷售額達到1,390萬美元,去年第一季為960萬美元,較去年同期成長45%。回想一下,2024 年第一季 EGRIFTA SV 的銷售額受到專業藥局庫存減少的影響。

  • Trogarzo net sales in the first quarter of fiscal 2025 amounted to $5.2 million compared to $6.7 million for the same quarter last year or a decrease of 22%. The decrease is mainly due to the continuing impact of new competitors in the past few years, and we do expect sales to stabilize at this level this year.

    Trogarzo 2025 財年第一季的淨銷售額為 520 萬美元,而去年同期為 670 萬美元,下降了 22%。下降主要是由於過去幾年新競爭對手的持續影響,我們預計今年的銷售額將穩定在這個水平。

  • In the first quarter of 2025, cost of goods sold came in at $3.5 million, down from $5.3 million in the same quarter of last year. EGRIFTA gross margins were positively affected by the reversal of a $713,000 provision, which we had built prior to the approval of our F8 formulation. And these margins came in at around 90% when excluding this reversal, which is in line with historical values. And Trogarzo margins were 48%, consistent with the transfer pricing agreement with TaiMed.

    2025 年第一季度,銷售成本為 350 萬美元,低於去年同期的 530 萬美元。我們在 F8 方案獲得批准之前建立的 713,000 美元撥備的撤銷對 EGRIFTA 毛利率產生了積極影響。如果排除此逆轉,利潤率將達到 90% 左右,與歷史值一致。Trogarzo 的利潤率為 48%,與與 TaiMed 的轉讓定價協議一致。

  • Again, in the first quarter of 2025, our optimized operating structure helped us achieve a positive adjusted EBITDA even with the effect of the drug shortage and the fact that we started spending on the preparation of filing of the Ionis products with Health Canada and on an eventual launch should these products be approved.

    同樣,在 2025 年第一季度,即使受到藥品短缺的影響,並且我們開始花錢準備向加拿大衛生部提交 Ionis 產品申請,並在這些產品獲得批准後最終上市,我們優化的運營結構仍幫助我們實現了正調整後 EBITDA。

  • R&D expenses in Q1 came in at $3 million versus $3.8 million last year or a decrease of 21%. Again, in the first quarter of 2025, we were able to claim non-reimbursable federal R&D tax credits for an amount of $194,000 to reduce our income tax expense.

    第一季的研發費用為 300 萬美元,而去年同期為 380 萬美元,下降了 21%。同樣,在 2025 年第一季度,我們可以申請 194,000 美元的不可退還的聯邦研發稅收抵免,以減少我們的所得稅支出。

  • Selling expenses came in at $6.5 million in Q1 2025 compared to $5.7 million for the same 3-month period last year. Selling expenses have stabilized in 2024 and should continue at roughly the same level in the next few quarters as the focus on top and bottom-line growth remains our main objective.

    2025 年第一季的銷售費用為 650 萬美元,而去年同期的銷售費用為 570 萬美元。銷售費用在 2024 年已經趨於穩定,並且在接下來的幾個季度中應該會繼續保持大致相同的水平,因為關注頂線和底線增長仍然是我們的主要目標。

  • G&A expenses in Q1 2025 amounted to $4.2 million as compared to $3.8 million for the first quarter of 2024 or a 10% increase. The increase in G&A expenses is mostly due to higher stock-based compensation and higher professional fees.

    2025 年第一季的 G&A 費用為 420 萬美元,而 2024 年第一季為 380 萬美元,成長了 10%。一般及行政費用的增加主要是因為股票薪酬和專業費用的增加。

  • Net finance costs were again lower in the first quarter of 2025 and came in at $1.5 million. This includes interest of $1 million on long-term debt compared to $2.3 million in 2024, mostly due to lower interest rates and the lower debt balance. Finance costs also include a noncash loss on warrant revaluation of $450,000.

    2025 年第一季淨財務成本再次下降,為 150 萬美元。其中包括 100 萬美元的長期債務利息,而 2024 年為 230 萬美元,主要原因是利率較低和債務餘額較低。財務成本還包括 45 萬美元的認股權證重估非現金損失。

  • As mentioned earlier, adjusted EBITDA for the first quarter was $2.3 million, up from negative $247,000 in the same period last year. February 28, 2025, we had cash and cash equivalents of $4.6 million. We had an unusually high amount of accounts receivable at the end of the quarter for $22 million due to the concentration of orders for EGRIFTA in the last two weeks of the quarter. These were all collected during the month of March.

    如前所述,第一季調整後的 EBITDA 為 230 萬美元,高於去年同期的負 24.7 萬美元。截至 2025 年 2 月 28 日,我們的現金和現金等價物為 460 萬美元。由於 EGRIFTA 訂單集中在本季最後兩週,導致本季末我們的應收帳款金額異常高,達到 2,200 萬美元。這些都是三月收集的。

  • During the first quarter, we temporarily drew an additional $5 million on the TD revolving credit facility. This amount was repaid in March. As per the terms of the TD agreement, we also repaid approximately $900,000 of capital on the TD term loan.

    在第一季度,我們暫時從 TD 循環信貸額度中提取了額外的 500 萬美元。這筆款項已於三月償還。根據 TD 協議的條款,我們還償還了 TD 定期貸款的約 900,000 美元本金。

  • We will now open the call for your questions. Operator?

    我們現在開始回答大家的提問。操作員?

  • Operator

    Operator

  • (Operator Instructions) Andre Uddin, Research Capital.

    (操作員指示) Andre Uddin,Research Capital。

  • Andre Uddin - Managing Director - Healthcare Research

    Andre Uddin - Managing Director - Healthcare Research

  • Paul, Philippe, John, Christian and Joanne, congratulations on your FDA EGRIFTA approvals. Just in terms of business development, are you looking for new products in the same therapeutic areas? And would you also consider -- given where you are, would you also consider targeting a drug acquisition, that is, a drug that's already approved? Or would you try to in-license late-stage drug candidates?

    保羅、菲利普、約翰、克里斯蒂安和喬安妮,恭喜你們獲得 FDA EGRIFTA 批准。僅就業務發展而言,您是否正在尋找相同治療領域的新產品?而您是否還會考慮—考慮到您的現狀,您是否還會考慮收購藥物,即已經獲得批准的藥物?或者你會嘗試獲得後期候選藥物的許可嗎?

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Well, I think that we want to be making any of these acquisitions. Thank you for your question, Andre. But we want to make this as accretive as possible. So we never wanted to take any risk with a drug that is not approved or has a 50-50 percent chance of being approved. So we want to focus on very late stage, where we know that the drug has a very high chance of success for being approved.

    嗯,我認為我們想要進行這些收購。謝謝你的提問,安德烈。但我們希望盡可能地增加這一數量。因此,我們絕不會冒險嘗試尚未獲批或獲批幾率只有 50% 的藥物。因此,我們希望將重點放在非常後期的階段,因為我們知道該藥物獲得批准的成功率非常高。

  • And obviously, if you want to draw more to the bottom line, you want to drive synergies with the current infrastructure we have. So the first priority is to find a product that would fit the bag that we currently have in the US. You would recall that half of our targets in the US are community infectious disease doctors. So anything that would actually match these targets would drive synergies right away because we have 25 people on the ground that can be active on day one.

    顯然,如果您想獲得更多利潤,您需要與我們現有的基礎設施產生協同效應。因此,首要任務是找到適合我們目前在美國擁有的包裝的產品。您可能還記得,我們​​在美國的目標客戶中有一半是社區傳染病醫生。因此,任何能夠真正符合這些目標的事情都會立即產生協同效應,因為我們在當地有 25 名員工可以在第一天就開始工作。

  • And in Canada, because we are starting to have small rare disease in rare cardio and rare immunology, having a second product in that bag for those few reps would obviously be very synergistic as well.

    在加拿大,由於我們開始在罕見心臟病和罕見免疫學領域出現小型罕見疾病,因此在包中放置第二種產品顯然也會有很好的協同作用。

  • John, do you want to add anything about what we have lining up?

    約翰,你想補充我們正在做的事情嗎?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. Andre, we have a number of nice targets that we're looking at in line with what Paul said in these areas that are synergistic. And to your other question about accretive assets that are already on the market, well, we've also identified a number of opportunities there. Those are a little bit tougher to find and a little more complicated, but I think it's not without possibility that we could find one there as well.

    是的。安德烈,我們有許多很好的目標,我們正在根據保羅所說的在這些領域中發揮協同作用的目標來考慮這些目標。至於您提出的另一個有關已在市場上的增值資產的問題,我們也發現了許多機會。這些有點難以找到,也有點複雜,但我認為我們在那裡找到一個也並非沒有可能性。

  • Operator

    Operator

  • Justin Walsh, JonesTrading.

    賈斯汀·沃爾什(Justin Walsh),JonesTrading。

  • Justin Walsh - Analyst

    Justin Walsh - Analyst

  • Can you provide more color on how you plan to facilitate the transition from EGRIFTA WR -- rather, from EGRIFTA SV to EGRIFTA WR? And I believe that you mentioned expecting replacement around early 2026. So how should we kind of be viewing this transition in the interim there?

    您能否詳細說明您計劃如何促進從 EGRIFTA WR(或 EGRIFTA SV)到 EGRIFTA WR 的過渡?我相信您提到預計在 2026 年初左右進行更換。那麼,我們該如何看待這段過渡時期呢?

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Thank you, Justin, for the question. John will answer your question in more details. But obviously one of the limitation, as you can imagine, is payers. So if the transition is not orchestrated the best possible way, you may have people who would want to jump on the F8 right away and if, for some reasons, the insurers are not going to be ready to reimburse.

    謝謝賈斯汀提出的問題。約翰將更詳細地回答您的問題。但顯然,正如您所想像的,其中一個限制因素是付款人。因此,如果過渡沒有以最佳方式進行,那麼可能會有人想立即加入 F8,而且由於某些原因,保險公司不會準備賠償。

  • So that's why we're planning for a very efficient period of time of transition based on previous experience when we transitioned the F1 to the F4.

    因此,我們根據從 F1 過渡到 F4 的先前經驗,規劃了一個非常有效率的過渡期。

  • John, do you want to provide additional details?

    約翰,你想提供更多詳細資訊嗎?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. Well, as Paul said, we do have experience in the transition from the F1 to F4. So we've modeled a similar time line. Obviously, the first step in the process is we've got to, once we have -- now that we have the final label, is the manufacturing and packaging of the new product. And that just takes some time. So you're looking about three months or more to get the product into the pharmacies.

    是的。嗯,正如保羅所說,我們確實有從 F1 到 F4 的過渡經驗。因此我們建立了一個類似的時間軸模型。顯然,這個過程的第一步是,一旦我們有了最終的標籤,我們就必須製造和包裝新產品。這只是需要一些時間。因此,您需要等待大約三個月或更長時間才能將產品送入藥局。

  • We can't actually start the -- load the new pricing and NDC numbers in the system prior to about 30 days to product availability. So that's the next stage, where we then begin contacting the payers and ensure that the new pricing and NDC numbers are loaded into the system.

    實際上,我們無法在產品上市前 30 天左右開始在系統中載入新的定價和 NDC 編號。所以這是下一個階段,我們開始聯繫付款人並確保新的定價和 NDC 號碼被加載到系統中。

  • And then it's a process of transition, which our patient support program is prepared to manage very well and seamlessly. We have this as a transition period of -- in the neighborhood of six months because some payers are slower than others to update their systems. But obviously, our goal would be to do this as quickly as possible.

    這是一個過渡過程,我們的患者支援計劃已做好準備,很好地、無縫地管理它。我們將此作為一個過渡期——大約六個月,因為一些付款人更新系統的速度比其他付款人慢。但顯然,我們的目標是盡快完成這一目標。

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • And our sales meeting with the field force is already set. We want to obviously build a fair amount of enthusiasm related to that. But again, it takes a well-orchestrated transition, and this is what we have laid out in front of us. Thanks.

    我們與現場人員的銷售會議已經確定。我們顯然希望在這方面激發出相當大的熱情。但同樣,這需要一個精心策劃的轉變,這就是我們面前所規劃的。謝謝。

  • Justin Walsh - Analyst

    Justin Walsh - Analyst

  • Got it. And yes, one more question. I'm just curious if you can maybe comment and remind us on your medium- to long-term expectations for growth in the EGRIFTA franchise.

    知道了。是的,還有一個問題。我只是好奇您是否可以評論一下並提醒我們您對 EGRIFTA 特許經營成長的中長期預期。

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Yes. Well, what I said, Justin, is that we currently have the wind blowing our way because excess visceral abdominal fat is being recognized more than ever before. It's being linked to cardiovascular risk in HIV patients more than ever before.

    是的。嗯,賈斯汀,我想說的是,我們目前正處於有利地位,因為人們比以往任何時候都更認識到內臟腹部脂肪過多的問題。它與愛滋病患者心血管風險的關聯比以往任何時候都更加密切。

  • And in fact, I suspect that the way we're bouncing back after the drug shortage is related to the demand that we have created for this product. We're pretty impressed with the way we're bouncing back, which tells me that this product is becoming more and more relevant.

    事實上,我認為我們在藥品短缺之後的恢復與我們為該產品創造的需求有關。我們對我們的反彈方式印象深刻,這告訴我這個產品變得越來越重要。

  • John, do you want to speak about the future?

    約翰,你想談談未來嗎?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Well, I mean, one of our best indicators of growth is our enrollments. And year-to-date, we're at 15% growth in enrollments over last year, even with the supply disruption that we had. So I think that's a good indicator of increasing demand. And our unique patients have already bounced back above where they were the same period last year. So I think that's a good indication that the patient base is back to where it was. So we expect to see continued growth from here throughout the year.

    嗯,我的意思是,我們最好的成長指標之一就是我們的入學人數。今年迄今為止,儘管出現了供應中斷的情況,但我們的入學人數仍比去年增加了 15%。所以我認為這是需求增加的一個很好的指標。我們的獨立患者數量已經回升至去年同期的水平。所以我認為這是一個很好的跡象,表明患者數量已經恢復到原來的水平。因此,我們預計全年將繼續成長。

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • And Justin, let me just add the fact that you've seen the publication coming from medical. So we are active to obviously ensure that there's publications, publications that carry momentum for the MSLs on the ground, for the reps. So every time that you leverage the medical activities to providing additional data to the field force, they sell more. That's the business model that has worked for us.

    賈斯汀,我只想補充一點,你已經看到了來自醫學界的出版品。因此,我們積極確保有出版物,這些出版物可以為當地的 MSL 和代表提供動力。因此,每次您利用醫療活動為現場人員提供額外的數據時,他們就會賣出更多產品。這就是對我們有效的商業模式。

  • Operator

    Operator

  • And this is the operator. Just checking, do you all have any questions on the webcast?

    這是接線生。只是想確認一下,大家對網路直播還有什麼疑問嗎?

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • We do. There's a few. I'll read them out. So first question is on the decline in Trogarzo sales. So we're seeing a stabilization. Why is it taking so long to stabilize? Why is there a continued negative impact?

    是的。有幾個。我會唸出來。所以第一個問題是關於 Trogarzo 銷售量的下降。所以我們看到了穩定。為何需要這麼長時間才能穩定下來?為什麼負面影響會持續存在?

  • John Leasure - Global Commercial Officer

    John Leasure - Global Commercial Officer

  • Yes. So we -- with the duration of therapy being about two years and the fact that we had higher enrollments previously, we're actually losing more patients than we're gaining. And that's why although the enrollments have stabilized and in fact actually grown this quarter, we're still losing some of the existing patient base, which we project will level out.

    是的。因此,由於治療時間約為兩年,而且我們之前的入院人數較多,因此我們實際上失去的患者比獲得的患者還多。這就是為什麼儘管本季度的入學人數已經穩定下來並且實際上有所增長,但我們仍然在失去一些現有的患者群,我們預計這一數字將會趨於平穩。

  • So Trogarzo enrollments are up 16% year-to-date over last year. So that's a positive sign that we're not seeing further decline in utilization. But again, some of those existing patients from the higher previous enrollments are transitioning out.

    因此,今年迄今為止,Trogarzo 的入學人數比去年增加了 16%。這是一個積極的信號,表明利用率不會進一步下降。但同樣,一些來自先前較高入學人數的現有患者正在轉出。

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • There's also a question on tariffs. You've talked about tariffs for EGRIFTA, but do you see any tariffs on Trogarzo or the Ionis products?

    還有一個關於關稅的問題。您談到了 EGRIFTA 的關稅,但您是否認為 Trogarzo 或 Ionis 產品也會被徵收關稅?

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Well, we don't see any issue. I mean, Philippe, you're close to this file. We don't see any issue for Trogarzo when it comes down to TaiMed because this is a transfer price. And then what is the situation for Ionis?

    嗯,我們沒有發現任何問題。我的意思是,菲利普,你已經接近這個文件了。當涉及到 TaiMed 時,我們認為 Trogarzo 不會遇到任何問題,因為這是一個轉讓價格。那麼 Ionis 的情況如何呢?

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • Ionis, the products are manufactured in Europe and they won't pass through the US border. So we don't see any risk on Ionis.

    Ionis,這些產品在歐洲製造,不會經過美國邊境。因此我們認為 Ionis 不存在任何風險。

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • So again, it's very difficult at this time to provide additional information. But what I wanted to make clear this morning is that we are following the situation very closely. We absolutely know the components that are passing through the border. And for now, the exposure we have is related to the SF -- the current formulation of -- SV formulation of EGRIFTA. And we don't foresee major implications.

    因此,現在再次提供更多資訊非常困難。但我今天早上想明確表示的是,我們正在密切關注局勢發展。我們絕對知道穿越邊境的零件有哪些。目前,我們所接觸到的是 SF——EGRIFTA 的當前表述——SV 表述。我們預計不會產生重大影響。

  • And we will, as we said, transition to the F8 the best possible way.

    正如我們所說,我們將以最佳方式過渡到 F8。

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • And last question on -- so we were waiting on the approval of the F8 for the NASH program. Can you give an update? Or are we still looking for a partner there? Or what's the status?

    最後一個問題是——我們正在等待 F8 對 NASH 計劃的批准。能提供最新消息嗎?或者我們仍在那裡尋找合作夥伴?或者說現狀如何?

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Well, in fact, this comes once in a while in the different meetings and whenever we go to bio and whenever we see potential candidates. But there's so much action going on in the NASH space with innovative and different types of targets that it's very difficult for us to actually be having a value proposition that can translate to a real value. This being said, we will continue to be opportunistic.

    嗯,事實上,這種情況偶爾會在不同的會議中出現,每當我們去看履歷,每當我們看到潛在的候選人時,就會出現這種情況。但在 NASH 領域有太多的行動,有太多的創新和不同類型的目標,以至於我們很難真正提出一個可以轉化為真正價值的價值主張。話雖如此,我們仍將繼續抓住機會。

  • And if there are some compounds that are looking, and we know that there are many compounds that are in need of having a combination with a drug that can maintain lean mass, which we would do, and have a double type of mode of action on fibrosis and inflammation, we could be relevant. But at this time, this is not where we're spending time and creating expectation.

    如果有一些化合物值得關注,而且我們知道有很多化合物需要與可以維持瘦體重的藥物結合,我們會這樣做,並且對纖維化和發炎有雙重作用模式,我們可能會有相關性。但目前,這並不是我們花時間和創造期望的地方。

  • Philippe Dubuc - Chief Financial Officer, Senior Vice President

    Philippe Dubuc - Chief Financial Officer, Senior Vice President

  • And that's it for the questions, Paul.

    保羅,問題就到這裡。

  • Paul Levesque - President, Chief Executive Officer, Director

    Paul Levesque - President, Chief Executive Officer, Director

  • Well, I would like to thank you for joining our earnings call this morning. I want people to understand that the drug shortage was a one-off. It is behind us. From a demand point of view our business is very robust, and we are gearing up now to have a plan that will further improve the top line and, most importantly, the bottom line and return for investors. Thanks for joining again.

    好吧,我想感謝您今天上午參加我們的收益電話會議。我希望人們明白,藥品短缺只是一次性事件。它已經在我們的身後了。從需求的角度來看,我們的業務非常強勁,我們現在正準備制定一項計劃,以進一步提高營業收入,最重要的是提高利潤和投資者回報。感謝您再次加入。

  • Operator

    Operator

  • This concludes -- the conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

    至此——會議已經結束。感謝您參加今天的演講。您現在可以斷開連線。