Theratechnologies Inc (THTX) 2024 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies third-quarter 2024 earnings call. We would like to remind everyone that all figures on this call are quoted in US dollars. (Operator instructions) I would like to remind everyone that this conference call is being recorded today, Thursday, October 10, 2024 at 8:30 AM Eastern Time.

早安，女士們先生們，感謝你們的支持。歡迎參加 Theratechnologies 2024 年第三季財報電話會議。我們要提醒大家，本次電話會議中的所有數據均以美元報價。（操作員說明）我想提醒大家，本次電話會議是在東部時間今天（2024 年 10 月 10 日星期四）上午 8:30 錄製的。

I will now turn the call over to Julie Schneiderman, Senior Director of Communications and Corporate Affairs at Theratechnologies. Julie, please go ahead.

我現在將把電話轉給 Theratechnologies 傳播和企業事務高級總監 Julie Schneiderman。朱莉，請繼續。

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

謝謝接線員，大家早安。今天參加電話會議的是 Theratechnologies 總裁兼執行長 Paul Levesque 先生；資深副總裁兼財務長 Philippe Dubuc 先生。在問答環節，資深副總裁兼首席醫療官 Christian Marsolais 博士將參加問答環節；以及該公司的全球商務官 John Leasure。

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.

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，存在 Theratechnologies 所獲得的結果可能與這些陳述有重大差異的風險。

As such, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. The company refers current and potential investors to the forward-looking information section of Theratechnologies management's discussion and analysis issued this morning and available on SEDAR plus at sedarplus.ca and on EDGAR at www.sec.gov.

因此，公司不能保證任何前瞻性陳述都會實現，並提醒您不要過度依賴它們。該公司建議目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 plus（sedarplus.ca）和 EDGAR（www.sec.gov）上查看。

Forward-looking statements represent Theratechnologies expectations as of this morning, October 10, 2024. Additionally, today, the company is using the term adjusted EBITDA, which is not a financial measure under International Financial Reporting Standards or US Generally Accepted Accounting Principles, 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.

前瞻性陳述代表 Theratechnologies 截至 2024 年 10 月 10 日上午的預期。此外，公司今天使用的調整後EBITDA一詞，並非國際財務報告準則或美國公認會計原則下的財務衡量指標，調整後EBITDA不包括主要反映長期投資和融資影響的項目的影響決策而不是日常運營的結果。

Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period 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 plus and on EDGAR at the web address as mentioned earlier. Investors can also follow the company on LinkedIn and [X], formerly 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從一個時期到另一個時期的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 EBITDA 與淨虧損的對帳可在今天早上發布的 MD&A 中找到，可在 SEDAR plus 和 EDGAR 上查看，網址如前所述。投資者還可以在 LinkedIn 和 [X]（以前稱為 Twitter）上關注該公司，並在 Theratecnologies 投資者網站 theratec.com 上註冊提醒。

With that, I would now like to turn the conference over to our President and CEO, Paul Levesque.

現在，我想將會議交給我們的總裁兼執行長保羅·萊維斯克 (Paul Levesque)。

Thank you, Julie. Hello, everyone, and good morning. I'm pleased to be reporting of Theratechnologies financial results for the third quarter ended August 31, 2024. As I explained during our second quarter call, we have embarked on a new chapter at Theratechnologies focused on commercializing innovative treatments.

謝謝你，朱莉。大家好，早安。我很高興報告 Theratechnologies 截至 2024 年 8 月 31 日的第三季財務表現。正如我在第二季電話會議中所解釋的那樣，我們在 Theratechnologies 開啟了新的篇章，重點是創新療法的商業化。

This strategic pivot coupled with the cost structure that is fit for purpose has enabled the company to achieve profitability and deliver on our commitment to shareholders to be adjusted EBITDA positive quarter-after-quarter. In fact, in a short period of time, the turnaround is nothing short of spectacular.

這個策略支點加上適合目標的成本結構使公司能夠實現盈利，並兌現了我們對股東的承諾，即每季調整後的 EBITDA 為正值。事實上，在很短的時間內，這種轉變簡直是驚人的。

As you have seen today, our third quarter did not disappoint, and we have continued to demonstrate strength on the bottom line with an adjusted EBITDA figure of $7.2 million and a net profit of $3 million. Revenues for the quarter are also trending positively, up 8% from the same period last year and driven by our engine of growth, EGRIFTA SV.

正如您今天所看到的，我們的第三季度並沒有令人失望，我們繼續展現出強勁的盈利能力，調整後的 EBITDA 數據為 720 萬美元，淨利潤為 300 萬美元。在我們的成長引擎 EGRIFTA SV 的推動下，本季的營收也呈現正面趨勢，比去年同期成長 8%。

Enrollments, unique patients and units sold of EGRIFTA SV reached double-digit growth year-to-date compared to the same period last year. In fact, in the last six months of EGRIFTA SV has recorded, the drug has recorded its best performance in recent history, capturing patients and new prescribers at the non-precedented rate.

與去年同期相比，今年迄今 EGRIFTA SV 的註冊人數、獨特患者數量和銷售單位數量均實現了兩位數成長。事實上，在 EGRIFTA SV 記錄的最後六個月中，該藥物創下了近代以來的最佳表現，以前所未有的速度吸引了患者和新處方者。

By highlighting EGRIFTA SV's unique value proposition, we've been able to differentiate the therapy from weight loss drugs where the focus is on BMI. EGRIFTA SV reduces visceral abdominal fat which if left untreated can lead to serious medical conditions and is easily identifiable by measurement of waist circumference.

透過強調 EGRIFTA SV 的獨特價值主張，我們能夠將該療法與專注於 BMI 的減肥藥物區分開來。EGRIFTA SV 可減少內臟腹部脂肪，如果不及時治療，可能會導致嚴重的健康狀況，並且可以透過測量腰圍輕鬆識別。

Trogarzo remains one of the few options for the management of HIV multidrug resistance. While it has been facing strong competition over the past year, new prescriptions and refills of Trogarzo have stabilized and we do not expect further declines next year.

Trogarzo 仍然是治療 HIV 多重抗藥性的少數選擇之一。儘管 Trogarzo 在過去的一年中面臨著激烈的競爭，但新處方和補充藥物已經穩定下來，我們預計明年不會進一步下降。

Now, as previously announced in September, our CDMO responsible for the manufacturing of EGRIFTA SV implemented a non-expected voluntary shutdown following an FDA inspection in order to implement corrective measures to their plant. As a result, the production of two batches of EGRIFTA SV were canceled, thus creating pressure on current inventory.

現在，正如先前在 9 月宣布的那樣，我們負責 EGRIFTA SV 製造的 CDMO 在 FDA 檢查後實施了非預期的自願關閉，以便對其工廠實施糾正措施。因此，兩批次 EGRIFTA SV 的生產被取消，對當前庫存造成壓力。

It is important to note that the corrective measures have nothing to do with the manufacturing process of our medicine, but rather with the environment in which the product is manufactured. I want to be clear that the situation will have no impact at the patient level in 2024. However, we believe it will have an impact on X factory sales in the fourth quarter and in turn, total revenue for full year 2024.

值得注意的是，糾正措施與我們藥品的製造過程無關，而是與產品的製造環境有關。我想澄清的是，這種情況到 2024 年不會對患者產生影響。不過，我們認為這將對 X 工廠第四季的銷售產生影響，進而影響 2024 年全年的總收入。

Given this and considering current trends for Trogarzo, we are changing top line revenue guidance to be between $83 million and $85 million. This change does not reflect demand for EGRIFTA SV, which in recent history has never been so strong across all metrics, new patients, unique patients and unit sold. The new guidance reflects a constrained supply situation.

有鑑於此，並考慮到 Trogarzo 目前的趨勢，我們將營收指引更改為 8,300 萬美元至 8,500 萬美元之間。這項變更並不反映對 EGRIFTA SV 的需求，在最近的歷史中，該需求在所有指標、新患者、獨特患者和銷售單位方面從未如此強勁。新的指導反映了供應緊張的情況。

Despite the circumstances affecting our top line, we're happy to firm up guidance for adjusted EBITDA increasing it to $17 million to $19 million from $13 million to $15 million. This is a result of adapting our cost structure to our new strategic direction of refocusing efforts on commercial activities.

儘管情況影響了我們的收入，但我們很高興確定調整後 EBITDA 的指導，將其從 1300 萬美元增加到 1500 萬美元，增加到 1700 萬美元到 1900 萬美元。這是我們調整成本結構以適應我們重新將精力集中在商業活動的新策略方向的結果。

With a cash position of close to $39 million and such a robust trajectory for adjusted EBITDA, we are in a strong position to take things to the next level. Looking to 2025, I want to share the latest information we have on the supply of EGRIFTA SV. Our CDMO has reconfirmed it will resume activities mid-October and a manufacturing slot for EGRIFTA SV scheduled for the week of October 21.

憑藉接近 3900 萬美元的現金頭寸和如此強勁的調整後 EBITDA 軌跡，我們有能力將事情提升到一個新的水平。展望 2025 年，我想分享我們掌握的有關 EGRIFTA SV 供應的最新資訊。我們的 CDMO 已再次確認將於 10 月中旬恢復活動，並計劃於 10 月 21 日這一周恢復 EGRIFTA SV 的生產。

The Theratechnologies will file a prior authorization supplement or PAS with the review division. The PAS will include the remediation plan implemented by our CDMO and we expect to submit in early November. While we expect to have very limited supply of EGRIFTA SV in the latter part of November in terms of X factory sales, there will be still a six week inventory held at the wholesaler and specialty pharmacy level. This will be enough drug to meet patient demand until mid-January.

Theratechnologies 將向審查部門提交事先授權補充文件或 PAS。PAS 將包括我們的 CDMO 實施的補救計劃，我們預計將在 11 月初提交。雖然我們預計 11 月下旬 X 工廠銷售的 EGRIFTA SV 供應非常有限，但批發商和專業藥房層面仍將持有六週的庫存。這些藥物足以滿足一月中旬之前患者的需求。

FDA has upped 120 days to approve the PAS and enable the batch to be released. As such, we took the precautionary step to modify or to notify rather the FDA drug shortage staff of the situation and also advise the market. We are working closely with all stakeholders and remain confident that any impact on patients in 2025 will be avoided. Moreover, we believe that in the first part of 2025, we will fully make up for sales not recorded in the fourth quarter of 2024. We will continue to update the market as things becomes available.

FDA 已將批准 PAS 並允許該批次放行的時間延長了 120 天。因此，我們採取了預防措施，修改或通知 FDA 藥物短缺工作人員這一情況，並向市場提供建議。我們正在與所有利益相關者密切合作，並堅信 2025 年將避免對患者產生任何影響。而且，我們相信在2025年上半年，我們將完全彌補2024年第四季未錄得的銷售額。當情況變得可用時，我們將繼續更新市場。

Turning to the F8 formulation of tesamorelin, I want to provide an update on our time lines for a resubmission to the FDA. Following our Type A meeting with the FDA, we believe we have addressed all of the agency's questions, including the ones related to immunogenicity and microbiology and I'm confident these pieces are behind us.

談到 tesamorelin 的 F8 配方，我想提供有關重新提交給 FDA 的時間表的最新資訊。在與 FDA 舉行 A 類會議之後，我們相信我們已經解決了該機構的所有問題，包括與免疫原性和微生物學相關的問題，我相信這些問題都已經解決了。

We expect to have the file completed shortly and intend to submit by the end of November. The FDA has confirmed a four month review. It is also important to note that our CDMO for the F8 is not the same as our manufacturer for the F4.

我們預計文件很快就會完成，並打算在 11 月底之前提交。FDA 已確認進行四個月的審查。還要注意的是，我們 F8 的 CDMO 與 F4 的製造商不同。

Our team believes strongly in the benefits of tesamorelin as the only FDA approved treatment of its kind for people with HIV and lipodystrophy, and we are all hands on deck to bring this new formulation to market and to continue sharing our value proposition and new data. Next week, three Theratechnologies poster will be presented at IDWeek in Los Angeles. IDWeek is one of the formal scientific conferences in this field. One poster presents data linking excess visceral abdominal fat or EVAS to increase cardiovascular risk in people with HIV.

我們的團隊堅信Tesamorelin 的益處，因為它是FDA 批准的唯一一種治療HIV 和脂肪營養不良患者的同類療法，我們全力以赴，將這種新配方推向市場，並繼續分享我們的價值主張和新數據。下週，三張 Theratechnologies 海報將在洛杉磯 IDWeek 展出。IDWeek 是該領域的正式科學會議之一。一張海報提供的數據表明，過多的內臟腹部脂肪或 EVAS 會增加愛滋病毒感染者的心血管風險。

While a second poster documents how use of tesamorelin to reduce excess visceral abdominal fat can lower cardiovascular disease risk in people with HIV. And other posters of, will report on the study design and baseline characteristics of the Promise US trial, an observational real-world study of ibalizumab in heavily treatment-experienced patients with multidrug resistance.

第二張海報記錄如何使用替沙莫林減少過多的內臟腹部脂肪，從而降低愛滋病毒感染者心血管疾病的風險。其他海報將報告 Promise US 試驗的研究設計和基線特徵，該試驗是一項在經過大量治療的多重抗藥性患者中進行的伊巴利珠單抗觀察性現實世界研究。

We've also had the recent publications on ibalizumab data in the Journal of AIDS. As people live longer with HIV and with greater exposure to entire retroviral medicines, they may experience higher amounts of excess visceral abdominal fat and risk multidrug resistance. We look forward to sharing our findings with HIV clinicians and researchers and to contributing to the scientific and treatment discourse on HIV. In keeping with our commitment to adding value through medical activities, I would like to provide an update on our ongoing Phase 1 clinical trial of Sudocetaxel Zendusortide, our lead investigational PDC candidate.

我們最近也在《愛滋病雜誌》上發表了有關伊巴利珠單抗數據的文章。隨著愛滋病毒感染者的壽命延長，並且更多地接觸逆轉錄病毒藥物，他們可能會出現更多的內臟腹部多餘脂肪，並面臨多重抗藥性的風險。我們期待與愛滋病毒臨床醫生和研究人員分享我們的發現，並為愛滋病毒的科學和治療討論做出貢獻。為了履行我們透過醫療活動增加價值的承諾，我想提供我們正在進行的 Sudocetaxel Zendusortide（我們的主要研究性 PDC 候選藥物）一期臨床試驗的最新資訊。

At this time, recruitment for both cohorts in advanced ovarian cancer has been completed. We've had no reports of DLTs, including neuropathy and eye toxicities. One patient remains in the trial at the higher dose of 2.5 milligram per kilogram and we plan to share results once the last patient has completed treatment and the overall data analysis is finalized.

目前，兩個晚期卵巢癌隊列的招募已經完成。我們還沒有關於 DLT 的報告，包括神經病變和眼睛毒性。一名患者仍以每公斤 2.5 毫克的較高劑量參加試驗，我們計劃在最後一名患者完成治療且總體數據分析完成後分享結果。

Our strengthened financial positioning, in particular, our bottom line performance and cash position has changed many things for us, opening the door to new possibilities and collaboration. We have doubled down on our efforts to find new products to market and to enter into partnerships. To this end, we've made significant progress in our search for new products, both in the US and in Canada.

我們強化的財務定位，特別是我們的底線業績和現金狀況，改變了我們的許多事情，為新的可能性和合作打開了大門。我們加倍努力尋找新產品推向市場並建立合作關係。為此，我們在美國和加拿大尋找新產品方面取得了重大進展。

Based on our experience with EGRIFTA and Trogarzo as well as the commercial capabilities we have built, we are uniquely positioned to in-license and bring to market innovative therapies that challenge the standard of care in rare or niche markets. This requires a specialized set of skills and experience managing regulatory and market access requirements and specialized patient support initiatives.

基於我們在 EGRIFTA 和 Trogarzo 方面的經驗以及我們建立的商業能力，我們擁有獨特的優勢，能夠獲得許可並將挑戰稀有或利基市場護理標準的創新療法推向市場。這需要一套專門的技能和經驗來管理監管和市場准入要求以及專門的患者支援計劃。

We are confident that Theratechnologies has a compelling value proposition to offer. Our North American-focused strategy is very clear, and we are confident we can achieve our long-term objective of delivering sustained top and bottom line growth and value for shareholders.

我們相信 Theratechnologies 能夠提供令人信服的價值主張。我們以北美為中心的策略非常明確，我們有信心能夠實現為股東帶來持續的營收和利潤成長以及價值的長期目標。

With this, I'd like to turn the call over to Philippe, who will go over the period's financials in details. 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？

Thank you, Paul, and good morning, everyone. I'm pleased to report that we've recorded another strong quarter, both on the top and bottom lines with net sales of $22.6 million or 8.4% growth versus the same quarter last year. Furthermore, I want to highlight that the efforts to reorganize the cost structure of the company are continuing to pay off with $7.2 million of adjusted EBITDA or close to 30% of revenues, and we recorded a net profit of about $3 million for the quarter or $0.06 per share. I can now say that we've built a high-performing organization that can take on additional challenges as just mentioned by Paul.

謝謝你，保羅，大家早安。我很高興地向大家報告，我們的季度營收和利潤均表現強勁，淨銷售額為 2,260 萬美元，與去年同期相比增長了 8.4%。此外，我想強調的是，重組公司成本結構的努力正在繼續獲得回報，調整後的 EBITDA 為 720 萬美元，接近收入的 30%，本季淨利潤約為 300 萬美元。我現在可以說，我們已經建立了一個高績效的組織，可以應對保羅剛才提到的額外挑戰。

For the third quarter of fiscal 2024, net sales of EGRIFTA SV reached $16.7 million compared to $13.2 million in Q3 of last year, which represents a 27% increase year-over-year. As mentioned previously, inventory levels have reverted to normal levels, and we should continue to see that going forward. For the nine month period ended August 31, EGRIFTA revenues have grown 16% which is supported by our key performance indicators such as new enrollments and total unique patients.

2024財年第三季度，EGRIFTA SV的淨銷售額達到1,670萬美元，去年第三季的淨銷售額為1,320萬美元，較去年同期成長27%。如前所述，庫存水準已恢復至正常水平，我們應該繼續看到這種情況的發展。截至 8 月 31 日的九個月期間，EGRIFTA 營收成長了 16%，這得益於我們的關鍵績效指標（例如新入組人數和獨特患者總數）。

Trogarzo net sales in the third quarter amounted to $5.9 million compared to $7.7 million for the same quarter last year. The decrease was mainly due to lower unit sales in the quarter as compared to last year, mostly as a result of competitive pressures in the multidrug-resistant segment of the [HIV-1] market.

Trogarzo 第三季的淨銷售額為 590 萬美元，而去年同期為 770 萬美元。下降的主要原因是本季的單位銷售額與去年相比有所下降，這主要是由於[HIV-1]市場的多重抗藥性領域的競爭壓力。

This impact is stabilizing as sales of Trogarzo units to pharmacies have grown slightly in Q3 compared to Q2 of this year. In the third quarter of 2024, cost of sales came in at $4.5 million, down from $5 million in the same quarter of last year.

隨著第三季 Trogarzo 藥局銷售量與今年第二季相比略有成長，這種影響正在趨於穩定。2024 年第三季度，銷售成本為 450 萬美元，低於去年同期的 500 萬美元。

EGRIFTA gross margins for EGRIFTA were 91% which is in line with the historical values and Trogarzo margins were 48% consistent with the terms of the time and agreement. Again, in the third quarter of 2024, the rigorous management of spending in R&D, selling and G&A expense helped us achieve our fifth straight quarter of strong adjusted EBITDA as established as an objective early in 2023.

EGRIFTA 的毛利率為 91%，與歷史值一致，Trogarzo 的毛利率為 48%，與時間和協議條款一致。同樣，在 2024 年第三季度，對研發、銷售和一般行政費用支出的嚴格管理幫助我們實現了 2023 年初設定的目標，連續第五個季度實現強勁的調整後 EBITDA。

Adjusted EBITDA for the past four quarters was $17.4 million, which is why we increased our guidance this morning to $17 million to $19 million for 2024. We expect adjusted EBITDA to be flat to slightly positive in the fourth quarter compared to Q4 of last year, mainly because of the shortfall anticipated to the supply constraints discussed earlier. Although this shortfall will affect our revenues in Q4, patient supply will not be affected until mid-January, if at all, as there is inventory both at McKesson, our distributor and at the specialty pharmacy level.

過去四個季度的調整後 EBITDA 為 1740 萬美元，這就是為什麼我們今天早上將 2024 年的指引上調至 1700 萬至 1900 萬美元。我們預計第四季度調整後的 EBITDA 與去年第四季相比將持平至小幅正值，這主要是因為先前討論的供應限制預計會出現缺口。儘管這種短缺將影響我們第四季度的收入，但患者供應直到一月中旬才會受到影響（如果有的話），因為我們的經銷商 McKesson 和專業藥房都有庫存。

R&D expenses again decreased substantially in the third quarter of 2024 compared to the same period last year mostly due to lower spending on our oncology program, as well as lower expenses following the near completion of our life cycle management projects for both EGRIFTA SV and Trogarzo.

與去年同期相比，2024 年第三季的研發費用再次大幅下降，主要是由於我們的腫瘤學專案支出減少，以及 EGRIFTA SV 和 Trogarzo 生命週期管理專案接近完成後費用減少。

R&D expenses came in at $2.6 million versus $5.4 million last year for a 52% decrease. Selling expenses came in at $6.3 million for Q3 compared to $6.7 million for the same period last year. Selling expenses have stabilized in the past few quarters 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.

研發費用為 260 萬美元，較去年的 540 萬美元下降 52%。第三季的銷售費用為 630 萬美元，而去年同期為 670 萬美元。銷售費用在過去幾個季度已經穩定，並且在接下來的幾個季度應該會繼續保持在大致相同的水平，因為對營收和利潤成長的關注仍然是我們的主要目標。

G&A expenses in the third quarter of 2024 amounted to $3 million as compared to $3.7 million for the third quarter of 2023 or a 19% decrease. The decrease in G&A expenses is largely due to our decision to focus on our US commercial operations and on controlling expenses. Again, these expenses are expected to stabilize going forward as evidenced by the similar level of expenses in Q2 of this year.

2024 年第三季的一般管理費用為 300 萬美元，而 2023 年第三季為 370 萬美元，下降了 19%。一般及行政費用的減少主要是由於我們決定專注於美國商業運營並控制費用。同樣，這些費用預計未來將穩定下來，今年第二季的類似費用水準證明了這一點。

As you can see from our reduction of expenses in R&D and G&A in the past six quarters, we have now rightsized the organization to ensure that we are well on our way in our journey towards showing strong growth in adjusted EBITDA. As a result of this, we are pleased to report adjusted EBITDA in the third quarter of $7.2 million versus $2.2 million in the same period last year, a significant improvement of $5 million, a combination of top line growth and realignment of spending.

從過去六個季度我們減少研發和一般行政費用的情況可以看出，我們現在對組織進行了精簡，以確保我們在調整後 EBITDA 強勁增長的道路上順利前進。因此，我們很高興地報告第三季調整後 EBITDA 為 720 萬美元，而去年同期為 220 萬美元，顯著提高了 500 萬美元，這是營收成長和支出調整的結合。

Net finance costs in the third quarter amounted to $2.4 million and include interest of $2.3 million on the Marathon Loan Facility. As per the credit agreement, we have initiated the reimbursement of the principal in August 2024 and the loan will be amortized over a 36 month period. Our strong operations generate solid cash flow, enabling us to repay the facility in the contracted amounts of $5 million per quarter.

第三季的淨財務成本為 240 萬美元，其中包括馬拉松貸款設施的 230 萬美元利息。根據信貸協議，我們已於 2024 年 8 月開始償還本金，貸款將在 36 個月內攤提。我們強大的營運能力產生了穩定的現金流，使我們能夠每季以合約金額償還貸款 500 萬美元。

Even considering the first monthly repayment of the credit facility, we ended the third quarter on solid financial footing with cash, bonds and money market funds at the end of the quarter, amounting to $39 million, an increase of close to $3 million over Q2 of 2024 and we ended the quarter with $58.9 million drawn on the Marathon facility for a net debt position of $20 million.

即使考慮到信貸安排的第一個月還款，我們在第三季結束時仍保持著堅實的財務基礎，截至季度末，現金、債券和貨幣市場基金的金額為3,900 萬美元，比第二季度增加了近300 萬美元。

I'm also happy to report that we recorded a net profit of $3 million or $0.06 per share in the third quarter of 2024. As Paul briefly alluded to in his remarks, we are revising our guidance this morning for revenues of $83 million to $85 million for fiscal 2024, and increasing our guidance for adjusted EBITDA to between $17 million and $19 million even as we include the spending on our oncology program this year, pointing to the continued strong performance of our commercial operations for the remainder of the year.

我還很高興地報告，2024 年第三季我們將淨利潤 300 萬美元，即每股 0.06 美元。正如保羅在演講中簡要提到的那樣，我們今天早上將2024 財年收入預期修改為8300 萬美元至8500 萬美元，並將調整後EBITDA 的預期提高至1700 萬美元至1900 萬美元之間，即使我們將今年的腫瘤學計劃表明我們的商業業務在今年剩餘時間內將繼續保持強勁表現。

As previously mentioned, any additional spending on oncology after the completion of the Phase 1 trial will be carried out through partnerships. So this program will no longer affect our adjusted EBITDA in 2025 and beyond.

如前所述，第一階段試驗完成後，任何額外的腫瘤學支出都將透過合作夥伴進行。因此，該計劃將不再影響我們 2025 年及以後調整後的 EBITDA。

With that, Paul will be back for final comments. But first, we will now open the call to take your questions. We will start by taking questions from analysts. Operator?

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。我們將首先回答分析師的問題。操作員？

We will now begin the question and answer session to ask a question. (Operator instructions)

我們現在開始問答環節來提問。（操作員說明）

Justin Walsh, Jones Trading.

賈斯汀·沃爾什，瓊斯貿易公司。

Hi, thanks for taking the questions. I was wondering if you can provide any color on the remediation efforts being undertaken by the manufacturer and maybe outline some potential contingency plans if EGRIFTA SV manufacturing does not resume in mid-October?

您好，感謝您提出問題。我想知道您是否可以提供有關製造商正在採取的補救措施的任何信息，並概述如果 EGRIFTA SV 製造無法在 10 月中旬恢復生產的話，可能會概述一些潛在的應急計劃？

Thank you, Justin, for the question. So it is a complex situation, but we are in discussion almost every day with the manufacturers so that we can confirm the sequence of event that I have highlighted in my speech. And it comes down to making a submission of the PAS filing that will be comprehensive, which will come from the full appreciation of the collective measures.

謝謝賈斯汀的提問。因此，這是一個複雜的情況，但我們幾乎每天都在與製造商進行討論，以便我們可以確認我在演講中強調的事件順序。歸根結底，是提交全面的 PAS 文件，這將來自對集體措施的充分認可。

And as soon as we hear back from our CDMO and their interaction with their compliance division, that will give us all ammunition needed to go back to the review division and work with the drug shortage staff to engage with our review division so that they expedite the review.

一旦我們收到CDMO 的回覆以及他們與合規部門的互動，這將為我們提供返回審查部門所需的所有彈藥，並與藥品短缺工作人員合作，與我們的審查部門合作，以便他們加快審查速度。

And quite frankly, they don't need to do it in 15 days. They don't need to do it even in 30 days. We have enough supply at the patient level up the way until mid-January. So we are confident that period of time is long enough for the agency to approve the releasing of the batch that will be produced the week of October 21. So John, when it comes down to handling of the stock that we currently have, what do you have lining up?

坦白說，他們不需要在 15 天內完成。即使在 30 天內他們也不需要這樣做。直到一月中旬，我們在患者層面都有足夠的供應。因此，我們有信心，該機構有足夠的時間批准放行將於 10 月 21 日這一周生產的批次。約翰，當談到處理我們目前擁有的庫存時，您有什麼準備？

Well, we're managing inventory more closely in the fourth quarter just to ensure that we have equal distribution amongst all our specialty pharmacy partners. And we're working with our patient support program then to ensure we get product to the right location for the right patients. So I think that's how we're managing that, Justin.

好吧，我們在第四季度更加嚴格地管理庫存，只是為了確保我們在所有專業藥房合作夥伴之間進行平等分配。然後，我們正在與患者支援計劃合作，以確保我們將產品送到正確的地點，以供正確的患者使用。所以我認為這就是我們的管理方式，賈斯汀。

And just maybe to add just we do have another slot that is reserved after the one in the week of October 21. So we actually have multiple slots coming up. So if that one doesn't happen, there's more in the back of it.

也許補充一下，我們確實在 10 月 21 日這一周的空檔之後預留了另一個空檔。所以我們其實有多個插槽。因此，如果那件事沒有發生，背後還有更多的事情。

Got it. I was wondering if you can, if there's any sort of comment you can have on color for the timing expectations for the BD activity and potentially accretive assets there? And that's it for me. Thanks.

知道了。我想知道您是否可以對 BD 活動的時間預期以及那裡潛在的增值資產的顏色有什麼評論嗎？對我來說就是這樣。謝謝。

Yes. Well, I mean we've been active for a certain period of time, and I cannot tell you what I cannot tell you. However, I just want to tell you again that this new situation that we're in, when it comes down to being stronger on the bottom line of the firm with a strong cash position and you see the rhythm of the numbers now when it comes down to generating EBITDA.

是的。嗯，我的意思是我們已經活躍了一段時間，我不能告訴你我不能告訴你的事情。然而，我只是想再次告訴你，我們所處的新形勢是，當公司擁有強大的現金頭寸時，公司的盈利能力會更強，你會看到現在的數字節奏直至產生 EBITDA。

So we are in a much, in much better position than we used to be. We believe in the capabilities that John and his team have built in the US. You've seen how robust the performance of EGRIFTA is turning to be in an environment that was unsure a year ago.

所以我們現在的處境比以前好很多。我們相信約翰和他的團隊在美國建立的能力。您已經看到，在一年前還不確定的環境中，EGRIFTA 的性能變得多麼強勁。

So we're going to build on all of this. And quite frankly, it hasn't gone unnoticed by some of the biotechs in the US that might need a partner to advance their science. And I just want to stress again that this organization has a track record for establishing the science. So we do have medical activities on the ground. We're capable of conducting medical to medical session so that we can establish new medicines.

因此，我們將在此基礎上再接再厲。坦白說，美國的一些生技公司並沒有忽視這一點，他們可能需要合作夥伴來推進他們的科學發展。我只是想再次強調，這個組織在建立科學方面有著良好的記錄。所以我們確實在實地開展了醫療活動。我們有能力進行醫療會議，以便我們能夠開發新藥。

And there are many firms of our size in the US that actually specialize in 505 (inaudible) . We sell innovation, and we're proud of that, and that's the type of products that we're after. So stay tuned for the next phases of announcement, okay.

美國有許多像我們這樣規模的公司實際上專門從事 505（聽不清楚）。我們銷售創新，我們為此感到自豪，這就是我們所追求的產品類型。所以請繼續關注下一階段的公告，好嗎？

Andre Uddin, Research Capital.

安德烈·烏丁，研究資本。

Thank you. Hi, Paul, Philippe, Christian and John. Just in terms of looking at innovative products that you done to your portfolio, are you only looking at commercially available assets and with those drugs be in-licensed or required, and we do also got the Canadian sales force.

謝謝。嗨，保羅、菲利普、克里斯蒂安和約翰。就查看您對產品組合所做的創新產品而言，您是否只查看商業可用資產以及這些藥物是否已獲得許可或需要，而且我們也確實擁有加拿大銷售人員。

So we are looking couple of things. We're looking at the territories we master the most. So obviously, the US and Canada. We have capabilities in Canada, as you can imagine, being located here. If we need to actually set up a field force either in the US or Canada, we will. Obviously, the value proposition coming from an in-license or acquisition has to be compelling. So we'll look at this very closely.

所以我們正在尋找一些東西。我們正在關注我們最掌握的領域。顯然，美國和加拿大。正如您可以想像的那樣，我們在加拿大擁有能力。如果我們需要在美國或加拿大實際建立一支現場部隊，我們會的。顯然，來自許可或收購的價值主張必須引人注目。所以我們將非常仔細地研究這個問題。

And we wanted to be accretive as fast as possible. So that doesn't mean that there's not going to be any period of time to ramp up to get access and reimbursement. But to answer your question again, what is most important to us is the value proposition. We want to challenge standard of care and if there are some drugs in the US that are deprioritized by big pharma or small pharma companies, we are interested in making acquisition of that, too. So it could be a mix of what you just mentioned.

我們希望盡快實現成長。因此，這並不意味著不會有任何時間來增加訪問和報銷。但再回答你的問題，對我們來說最重要的是價值主張。我們想要挑戰護理標準，如果美國有一些藥物被大型製藥公司或小型製藥公司優先考慮，我們也有興趣收購它。所以它可能是你剛才提到的的混合體。

Okay, that's great. Thanks, Paul. And just in terms of EGRIFTA, do you plan on setting up a backup facility going forward?

好的，太好了。謝謝，保羅。就 EGRIFTA 而言，您是否計劃未來建立一個備份設施？

Philippe, do you want to take that question?

菲利普，你想回答這個問題嗎？

No, I don't think we'll need to. First of all, we're hoping to launch the F8 next year. We have another manufacturer and what we'll do is build up a solid inventory so that we have one or two years of material. So it's so expensive to set up these manufacturers that it's much cheaper to keep more inventory than less.

不，我認為我們不需要。首先，我們希望明年推出F8。我們還有另一家製造商，我們要做的就是建立可靠的庫存，以便我們可以擁有一兩年的材料。因此，建立這些製造商的成本如此之高，因此保留更多的庫存比保留更少的庫存要便宜得多。

Okay. And just to clarify, if you file your PAS in early November, would the review actually take up to four months? Or is based on the FDA shortage office, do you think it's going to be shorter than that?

好的。澄清一下，如果您在 11 月初提交 PAS，審核實際上需要長達四個月的時間嗎？或者是基於 FDA 短缺辦公室，你認為它會比這更短嗎？

Well, we absolutely believe, Andre, that we have and we will have the information needed to accelerate the review. Unfortunately, they have not confirmed that to us, and it's not a surprise, quite frankly, because they have to hear back from the compliance division first.

好吧，安德烈，我們絕對相信我們已經並且將擁有加速審查所需的資訊。不幸的是，他們還沒有向我們證實這一點，坦白說，這並不奇怪，因為他們必須先收到合規部門的回覆。

And the compliance division is working with our CDMO, and they need to see the finalization, the final report of their corrective measures. So this is a stepwise approach. What makes me believe that we're not going to face drug shortage at the patient level is that they have sufficient time to review our PAS submission until we actually run out of medicine mid-January.

合規部門正在與我們的 CDMO 合作，他們需要看到最終確定的糾正措施的最終報告。所以這是一個循序漸進的方法。讓我相信我們不會在患者層面面臨藥物短缺的問題是，他們有足夠的時間來審查我們提交的 PAS，直到我們在一月中旬真正用完藥物為止。

I would not understand why they would, in that case, knowing that we could face drug shortage. I would not understand why they would actually take up their 120 days. That's specifically why the drug shortage staff exist and all the divisions have to work together. So I'm absolutely confident that we'll find all the information needed to convince them to review our PAS filing in a period of time that will not actually lead to drug shortage.

我不明白為什麼他們會在這種情況下知道我們可能面臨藥品短缺。我不明白他們為什麼要花 120 天。這就是為什麼存在藥品短缺人員以及所有部門必須共同努力的原因。因此，我絕對有信心，我們會找到所有需要的信息，說服他們在一段時間內審查我們的 PAS 備案，而實際上不會導致藥品短缺。

That's good. And just in terms of TH1902, can we get an approximate time line on when the final data would be? Is that going to be in 2024 calendar year or 2025, do you think?

那挺好的。就TH1902而言，我們能否得到最終資料的大致時間軸？您認為是 2024 年還是 2025 年？

Christian, do you want to provide an update?

克里斯蒂安，你想提供更新嗎？

Yes, absolutely. First of all, Andre, it's progressing well. As you know, we had some AEs when we're administering the drug every three weeks now that it is the new regimen on a weekly basis with when we break three weeks of treatment, followed by one week break at the highest dose, which is the 2.5 milligram per kg, which was similar, you remember 300 milligram per meter square over three weeks. We don't see any VLT, which is a very good sign. It shows that eventually we can probably give more drug. And in terms of the overall analysis, it would probably come towards the later part of this year.

是的，絕對是。首先，安德烈，一切進展順利。如您所知，當我們每三週給藥一次時，我們會出現一些不良事件，因為這是每週一次的新治療方案，當我們中斷三週的治療，然後以最高劑量中斷一周時，即每公斤2.5 毫克，這很相似，你記得三週內每平方公尺300 毫克。我們沒有看到任何 VLT，這是一個非常好的跡象。這表明最終我們可能可以給予更多的藥物。而從整體分析來看，大概是今年下半年。

Okay, that's great. Thanks. That's it for me.

好的，太好了。謝謝。對我來說就是這樣。

(Operator instructions)

（操作員說明）

Louise Chen, Cantor.

路易絲·陳，康托爾。

Good morning, everyone. This is Carvey on for Louise from Cantor. Thank you for taking our question. First, can you discuss your strategy to ensure the sustainability of your EBITDA and bottom line performance that you've been able to generate the last few quarters.

大家早安。這是卡維為來自康託的路易絲發言。感謝您提出我們的問題。首先，您能否討論一下您的策略，以確保過去幾季產生的 EBITDA 和底線績效的可持續性。

Secondly, given the current status on EGRIFTA supply from a growth perspective, how might EGRIFTA sales growth look like in 2025 versus this year? Thank you.

其次，從成長的角度考慮 EGRIFTA 供應的現狀，與今年相比，2025 年 EGRIFTA 的銷售成長如何？謝謝。

So second question I'm going to ask John in a moment. But Philippe, for the first part, do you want to go ahead, please?

第二個問題我稍後要問約翰。但是菲利普，對於第一部分，你想繼續嗎？

Sure. So as I said in my speech, Carvey, the structure, the operating structure that we have right now is really ideal for both Trogarzo and EGRIFTA. So it's not that we've been cutting costs and to the detriment of generating new scripts and top line we're really ideally positioned. So we see any growth in top line in the next year or two will flow straight to the bottom line. We're not going to have to spend a lot more the cuts that we took did not affect any of our operating performance. So we're in a really good position.

當然。正如我在演講中所說，Carvey，我們現在擁有的結構和營運結構對於 Trogarzo 和 EGRIFTA 來說都非常理想。因此，這並不是說我們一直在削減成本，從而損害了新劇本的生成和營收，我們確實處於理想的位置。因此，我們認為未來一兩年收入的任何成長都將直接流向利潤。我們不需要花更多的錢，我們所採取的削減不會影響我們的任何經營績效。所以我們處於一個非常好的位置。

John?

約翰？

Yes. So in terms of performance for next year, we do anticipate that sales would be a little bit lighter early in Q1, but we think that would just completely reverse, so later in the quarter. So we have roughly 2.5 weeks at our wholesaler. We have 30 days roughly in the, at the specialty pharmacy level. So that 6.5 weeks of inventory. When that gets depleted down to very low levels, we'll just see very large orders later in the quarter. So assuming things go as Paul laid out, then Q1 should be basically a wash.

是的。因此，就明年的業績而言，我們確實預計第一季初期的銷售會有所減少，但我們認為這種情況會在本季稍後完全逆轉。所以我們在批發商那裡有大約 2.5 週的時間。我們在專業藥局層面大約有 30 天的時間。這樣就有6.5週的庫存。當其消耗到非常低的水平時，我們將在本季度晚些時候看到非常大的訂單。因此，假設事情按照保羅的計劃進行，那麼第一季基本上應該是一場洗牌。

So this is important to stress again, X factory sales will be affected in the fourth quarter which is not related to demand. And as soon as we actually have the release of that batch, we will make up for sales. And we have enough in the distribution pipeline for six weeks. So we have until mid-January to be able to serve our patients.

所以這裡要再次強調的是，X工廠的銷售在第四季會受到影響，這與需求無關。一旦我們真正發布了該批次，我們就會彌補銷售。我們的分銷管道已經足夠六週了。因此，我們必須在一月中旬之前才能為患者提供服務。

Got it. That's helpful. Thanks so much.

知道了。這很有幫助。非常感謝。

This concludes our question and answer session. I would like to turn the conference back over to Paul Levesque.

我們的問答環節到此結束。我想把會議重新交給保羅·萊維斯克。

Before we turn over to Paul, there's a few questions on the webcast. So one is on Trogarzo, John. Please give us more color on why you expect Trogarzo sales to stabilize in 2025?

在我們向保羅提問之前，網路廣播中有幾個問題。約翰，其中之一是特羅加佐。請詳細說明為什麼您預計 Trogarzo 的銷售量將在 2025 年穩定下來？

Well, as we look at unique patients and where they are trending. It has sort of stabilized in the last four to five months. Plus, you see sort of, as we had more patients earlier on as more patients drop off, we're getting more patients dropping off than we are coming in, you see a more rapid decline.

好吧，當我們觀察獨特的患者以及他們的趨勢時。在過去的四到五個月裡，它已經趨於穩定。另外，你會看到，由於我們早些時候有更多的患者，隨著越來越多的患者流失，我們流失的患者比進來的患者還要多，你會看到下降速度更快。

But as that begins to stabilize moving forward, then we see things sloping off. So our, what we anticipate in terms of enrollments, we're right there. So we're not seeing any further decline in enrollments. And so we anticipate going forward that things have sort of leveled out where they are.

但隨著這種情況開始穩定向前發展，我們就會看到事情開始傾斜。因此，我們對入學人數的預期就在那裡。因此，我們沒有看到入學人數進一步下降。因此，我們預計未來情況將趨於平穩。

And there's a question also, how would you characterize your ability to meet the loan covenants with Marathon?

還有一個問題，您如何評價您履行與 Marathon 的貸款契約的能力？

So right now, there's two main covenants, the liquidity covenant, which is at $17.5 million, and we have $40 million in the bank. So we're fine there. We're also building quite a cushion on the adjusted EBITDA line covenant because this is a rolling 12 month covenant and as we continuously beat our own expectations, we're building more of a cushion.

所以現在有兩個主要的契約，即流動性契約，金額為 1750 萬美元，我們的銀行存款為 4000 萬美元。所以我們在那裡很好。我們也在調整後的 EBITDA 額度契約上建立了相當大的緩衝，因為這是一個滾動的 12 個月契約，隨著我們不斷超出自己的預期，我們正在建立更多的緩衝。

And there's a second part to this question, if you had discussions on waivers?

這個問題還有第二部分，你們是否討論過豁免？

We haven't, because we don't need them. Obviously, if the EGRIFTA shortage goes into 2025 deeper in the year, we'll definitely have to talk to them, but that's really not the plan right now. So we're in a very good position with the Marathon credit facility.

我們沒有，因為我們不需要它們。顯然，如果 EGRIFTA 短缺問題持續到 2025 年，我們肯定必須與他們交談，但這確實不是現在的計劃。因此，我們在馬拉松信貸安排方面處於非常有利的地位。

And that's it, Paul, for questions. So you can.

保羅，問題就這樣了。所以你可以。

Well, thank you, everyone, for attending the call today. Our bottom line is strong as demonstrated by nearly $12 million of adjusted EBITDA year-to-date and the increase in our guidance. No doubt, we will continue to maximize our profitability through the sustained growth of EGRIFTA SV and the planned expansion of our product portfolio. We are seizing every opportunity to leverage our commercial experience and expertise across North America, and I look forward to updating you on key developments. Again, thank you for your support, and have a great day.

好的，謝謝大家參加今天的電話會議。年初至今近 1,200 萬美元的調整後 EBITDA 以及我們指引的增加證明了我們的獲利強勁。毫無疑問，我們將繼續透過 EGRIFTA SV 的持續成長和計劃的產品組合擴展來最大化我們的獲利能力。我們正在抓住每一個機會，利用我們在北美的商業經驗和專業知識，我期待著向您通報關鍵進展的最新情況。再次感謝您的支持，祝您有美好的一天。

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。