Cumberland Pharmaceuticals Inc (CPIX) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon and welcome to Cumberland Pharmaceuticals Second Quarter 2026 Company Update and Financial Report. This call is being recorded at the company's request and will be archived on its website for one year from today's date. I would now like to turn it over to Emily Kent, the Dalton Agency who handles Cumberland's communications. Emily, please proceed.

    下午好,歡迎參加 Cumberland Pharmaceuticals 2026 年第二季公司更新與財務報告。本次電話會議依公司要求進行錄音,並將自今日起在公司網站存檔一年。現在我想把時間交給負責 Cumberland 對外溝通的 Dalton Agency 之 Emily Kent。Emily,請開始。

  • Emily Kent - Investor Relations

    Emily Kent - Investor Relations

  • Hello everyone and thank you for joining us today. This afternoon, Cumberland will issue a press release announcing its second quarter financial results.

    各位好,感謝今天加入我們。今天下午,Cumberland 將發布新聞稿,公布其第二季財務結果。

  • The release will provide an overall company update, including key developments during the quarter. The release, which includes the related financial tables, will be found on the company's website at www.cumberlandpharma.com.

    該新聞稿將提供公司整體更新,包括本季的關鍵進展。新聞稿(含相關財務表格)可於公司網站 www.cumberlandpharma.com 查閱。

  • During today's call, management will share an overview of those financial results and a company update, including recent developments and a discussion of Cumberland's clinical pipeline.

    在今天的電話會議中,管理團隊將分享上述財務結果概覽與公司更新,包括近期進展以及對 Cumberland 臨床研發管線的討論。

  • Participating in today's call are AJ Kazimi, Cumberland's Chief Executive Officer Todd Anthony, Vice President, Organizational Development and John Hamm, Chief Financial Officer. Please keep in mind that their discussions may include some forward-looking statements as defined in the Private Securities Reform Act. Those statements reflect the company's current views and expectations concerning future events and may involve risks as well as uncertainties.

    參與今天電話會議的有 Cumberland 執行長 AJ Kazimi、組織發展副總裁 Todd Anthony,以及財務長 John Hamm。請注意,他們的討論可能包含《私人證券訴訟改革法》所定義的某些前瞻性陳述。這些陳述反映公司對未來事件的目前觀點與預期,且可能涉及風險與不確定性。

  • There are many factors that could affect Cumberland's future results, including natural disasters, economic downturns, international conflicts, trade restrictions, public health epidemics, and others that are beyond the company's control. Those issues are described under the caption Risk Factors in Cumberland's annual report on Form 10-K and any subsequent updates filed with the SEC. Any forward-looking statements made during today's call are qualified by those risk factors.

    有許多因素可能影響 Cumberland 未來的業績,包括天災、經濟衰退、國際衝突、貿易限制、公共衛生疫情,以及其他超出公司控制範圍的因素。相關議題已在 Cumberland 的 Form 10-K 年度報告及其後向 SEC 提交的任何更新文件中「風險因素」章節加以說明。今天電話會議中所作的任何前瞻性陳述,均受上述風險因素之限制。

  • Despite the company's best efforts, actual results may differ materially from expectations, so information shared on this call should be considered current as of today only. Also, please remember that the company isn't responsible for updating any forward-looking statements, whether as a result of new information or due to future developments.

    儘管公司已盡最大努力,實際結果仍可能與預期有重大差異,因此本次電話會議分享的資訊僅應視為截至今日為止的最新資訊。此外,請記得公司不負責更新任何前瞻性陳述,不論係因新資訊或未來發展所致。

  • During today's call, there will be references to Cumberland's new product candidates. For more information, please visit the corporate website at www.cumberlandpharma.com. The company will also be providing some non-GAAP financial measures with respect to its performance. An explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that will be issued this afternoon.

    在今天的電話會議中,將提及 Cumberland 的新產品候選藥物。如需更多資訊,請造訪公司網站 www.cumberlandpharma.com。公司也將提供若干與其表現相關的非 GAAP 財務衡量指標。其說明以及與 GAAP 指標的調節,可在今天下午將發布之財報新聞稿的財務表格中找到。

  • If you have any questions, please hold them until the end of the call, at which point we will be happy to answer them. Management is also prepared to hold a follow-up conversation with shareholders after the call, if you prefer.

    若您有任何問題,請先保留至電話會議結束時,我們將很樂意回答。若您偏好,管理團隊也準備在會後與股東進行後續交流。

  • With that introduction, I'll turn the call over to Cumberland's Chief Executive Officer, AJ Kazimi.

    在以上開場之後,我將把電話會議交給 Cumberland 執行長 AJ Kazimi。

  • A. Kazimi - Chairman of the Board, Chief Executive Officer

    A. Kazimi - Chairman of the Board, Chief Executive Officer

  • Thank you, Emily, and good afternoon, everyone. We appreciate you joining us today as we review Cumberland's second quarter results and discuss one of the most significant milestones in our company's history.

    謝謝你,Emily,各位下午好。感謝各位今天加入我們,一同回顧 Cumberland 第二季業績,並討論公司歷史上最重要的里程碑之一。

  • In June, our shareholders overwhelmingly approved the strategic transaction with Apotex Health and on July 1, we successfully closed the agreement to integrate our branded U.S. Commercial businesses. This transformational transaction strengthened Cumberland's financial position, unlocked substantial value for our shareholders and established a solid foundation for the company's next phase of growth.

    6 月,我們的股東以壓倒性票數通過與 Apotex Health 的策略性交易;並於 7 月 1 日,我們成功完成協議交割,整合我們在美國的品牌商業業務。這項具轉型意義的交易強化了 Cumberland 的財務狀況,為股東釋放了可觀價值,並為公司下一階段的成長奠定了穩固基礎。

  • I'd like to take this opportunity to thank our shareholders for their support throughout this process. Over 99% of the voting shareholders voted in favour of the transaction. Their approval affirmed our strategy and reflected confidence in Cumberland's future as an innovation-focused biopharmaceutical company.

    我也想藉此機會感謝股東在整個過程中的支持。超過 99% 具有投票權的股東投票贊成該交易。他們的核准肯定了我們的策略,也反映出對 Cumberland 作為以創新為核心之生物製藥公司未來發展的信心。

  • We're also delighted to recently announce and fund a special dividend to return capital to our shareholders.

    我們也很高興近期宣布並發放特別股利,以回饋股東、返還資本。

  • After the dividend, we've retained sufficient capital to fund operations for the long-term while maintaining significant additional financial reserves for any special opportunities that may arise. Our strong financial position will provide the foundation for executing our plans as we pivot to a focus on developing new medicines for the future.

    在發放股利後,我們仍保留足夠資本以長期支應營運,同時維持可觀的額外財務準備,以因應可能出現的特殊機會。我們強健的財務狀況將成為執行計畫的基礎,協助我們轉向聚焦於開發未來的新藥。

  • As a reminder, under the terms of the transaction with Apotex, they acquired our portfolio of FDA-approved commercial brands and related U.S. Organizations.

    提醒各位,依與 Apotex 的交易條款,他們收購了我們的 FDA 核准商業品牌產品組合以及相關的美國組織。

  • Cumberland received $100 million in cash at closing with an additional $11 million due for inventory and transition payments along with a potential $10 million milestone payment.

    Cumberland 在交割時收到 1 億美元現金,另有 1,100 萬美元將用於庫存與過渡期付款,並可能另有 1,000 萬美元的里程碑付款。

  • Importantly, this transaction enables us to sharpen our strategic focus while maintaining the financial strength needed to advance our development programs. It also provides additional capital to invest in our clinical pipeline, pursue new opportunities, and continue to create overall value for our shareholders.

    重要的是,這項交易使我們得以更聚焦於策略重點,同時維持推進研發計畫所需的財務實力。它也提供額外資本,用於投資臨床研發管線、追求新機會,並持續為股東創造整體價值。

  • Our commercial portfolio served as the foundation of Cumberland's business for many years and facilitated our developing innovative therapies for patients with serious unmet medical needs.

    多年來,我們的商業產品組合一直是 Cumberland 業務的基礎,並促成我們為具有嚴重未被滿足醫療需求的患者開發創新療法。

  • With the divestiture of our commercial brands. Our strategy and focus now centres on advancing our ifetroban clinical programs which target multiple diseases with significant medical needs and substantial commercial opportunities. We believe monetizing the value of our commercial portfolio was well timed as our clinical programs have made great strides benefiting from years of scientific investment and clinical research. Several have now advanced to a point where they've generated very promising data, which has been highlighted in medical publications and in medical conferences.

    隨著我們剝離商業品牌產品。我們的策略與重點現已轉向推進 ifetroban 的臨床計畫,該計畫鎖定多種具有重大醫療需求與可觀商業機會的疾病。我們認為,在臨床計畫因多年科學投入與臨床研究而取得長足進展之際,將商業產品組合的價值變現正逢其時。其中數項計畫現已推進至產出相當具前景數據的階段,並已在醫學期刊與醫學會議中受到重點呈現。

  • Following our strategic transaction, we are now in a financial position to accelerate the funding for these clinical programs. And even if just one of our products in development goes on to receive FDA approval, that milestone has the potential to be a significant value creator for Cumberland.

    在完成策略性交易後,我們目前具備加速投入這些臨床計畫資金的財務條件。即使我們研發中的產品只有一項最終獲得 FDA 核准,該里程碑也有潛力為 Cumberland 創造顯著價值。

  • Now, I'd like to turn it over to Todd Anthony for the clinical update. Todd.

    接下來,我想把時間交給 Todd Anthony 進行臨床更新。Todd。

  • Todd Anthony - Vice President of Organizational Development

    Todd Anthony - Vice President of Organizational Development

  • Thank you, AJ.

    謝謝你,AJ。

  • Well, as previously noted, our key development programs are based on our first new chemical entity, ifetroban. It's a potent and selective thromboxane receptor antagonist that has now been administered to approximately 1,400 subjects across multiple clinical studies, demonstrating a strong safety profile. We are evaluating ifetroban across several advanced clinical programs for patients with a series of unmet medical needs.

    如先前所述,我們的關鍵研發計畫係以我們第一個新化學實體 ifetroban 為基礎。它是一種高效且具選擇性的血栓素受體拮抗劑,迄今已在多項臨床研究中給藥於約 1,400 名受試者,展現出良好的安全性特徵。我們正在多個進階臨床計畫中評估 ifetroban,用於一系列具有未被滿足醫療需求的患者。

  • I'll begin with our Duchenne Muscular Dystrophy or DMD program.

    我將先從我們的杜興氏肌肉萎縮症(Duchenne Muscular Dystrophy,DMD)計畫開始。

  • DMD is a rare fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart, and lung muscles. Our ifetroban product candidate is being developed specifically to preserve cardiac function and improve outcomes for patients living with DMD associated cardiomyopathy. We previously announced positive top-line results from our completed phase two FIGHT-DMD clinical trial demonstrating encouraging safety and biomarker findings that support continued development of the program.

    DMD 是一種罕見且致命的遺傳性神經肌肉疾病,會導致骨骼肌、心肌與肺部肌肉退化。我們的 ifetroban 候選產品正專門開發用於維持心臟功能,並改善罹患 DMD 相關心肌病變患者的治療結果。我們先前已公布已完成的第二期 FIGHT-DMD 臨床試驗之正向主要結果,顯示令人鼓舞的安全性與生物標記發現,支持該計畫持續開發。

  • Earlier this year, the FDA granted fast-track designation for ifetroban in DMD, recognizing both the seriousness of the disease and the significant unmet medical need that exists for these patients. This designation allows for more frequent FDA interaction, rolling data submissions, and earlier guidance throughout the approval process. The program has also previously received both orphan drug designation and rare pediatric disease designation from the FDA, further reinforcing the importance of this development effort.

    今年稍早,FDA 授予 ifetroban 用於 DMD 的快速通道(fast-track)資格,認可該疾病的嚴重性以及這些患者所面臨的重大未被滿足醫療需求。此資格可在核准流程中提供更頻繁的 FDA 互動、滾動式資料提交,以及更早期的指引。該計畫先前亦已獲 FDA 授予孤兒藥資格與罕見兒科疾病資格,進一步強化此開發工作的重要性。

  • During the second quarter, new biomarker data from the FIGHT-DMD clinical study was presented at the Parent Project Muscular Dystrophy Annual Conference. Those findings provide additional evidence that the therapy can help preserve cardiac function in this patient population. You can review that presentation on our corporate website. We continue to hold discussions with the FDA regarding the regulatory pathway for this program with another meeting scheduled this fall as we remain focused on determining the most efficient path toward approval. We look forward to providing additional updates as those discussions progress.

    在第二季期間,FIGHT-DMD 臨床研究的新生物標記資料於 Parent Project Muscular Dystrophy 年度大會上發表。這些發現提供了更多證據,顯示該療法可協助在此患者族群中維持心臟功能。您可在我們的公司網站上查看該簡報。我們持續就此計畫的法規途徑與 FDA 進行討論,並已安排於今年秋季再度召開會議;我們仍專注於確定通往核准的最有效率路徑。隨著討論推進,我們期待提供更多更新。

  • Turning now to our systemic sclerosis or SSC program. We are also studying ifetroban in patients with systemic sclerosis, a rare autoimmune disease characterized by progressive fibrosis and vascular dysfunction that can affect multiple organs throughout the body. Patient enrolment in the study has been completed. An evaluation of the Phase 2 study data is underway with top-line results anticipated this year.

    接著談我們的系統性硬化症(systemic sclerosis,SSC)計畫。我們也正在系統性硬化症患者中研究 ifetroban;系統性硬化症是一種罕見自體免疫疾病,其特徵為進行性纖維化與血管功能障礙,可能影響全身多個器官。本研究的患者收案已完成。目前正進行第二期研究資料評估,預期今年公布主要結果。

  • Our third advanced clinical program, Fighting Fibrosis, is evaluating ifetroban in patients with idiopathic pulmonary fibrosis, or IPF, the most common form of progressive fibrosing interstitial lung disease. The study's interim safety analysis was performed evaluating the first cohort of patients completing 12 weeks of treatment. The independent committee concluded no new safety signals were identified and no changes in study conduct were needed.

    我們第三個進階臨床計畫「Fighting Fibrosis」正在評估 ifetroban 用於特發性肺纖維化(idiopathic pulmonary fibrosis,IPF)患者;IPF 是最常見的進行性纖維化間質性肺病類型。研究已完成期中安全性分析,評估第一批完成 12 週治療的患者隊列。獨立委員會結論為未發現新的安全性訊號,且無需變更研究執行方式。

  • Based on those findings, patient enrolment in the study has continued and we will expect to announce interim efficacy results as the next milestone.

    基於上述發現,研究持續進行患者收案,我們預期下一個里程碑將是公布期中療效結果。

  • In addition to our company sponsored clinical programs, we have collaborated with Vanderbilt Health to evaluate ifetroban for the prevention of cancer metastasis in patients with high-risk solid tumours.

    除公司主導的臨床計畫外,我們也與 Vanderbilt Health 合作,評估 ifetroban 用於預防高風險實體腫瘤患者的癌症轉移。

  • During the second quarter, we jointly announced positive results from their phase two clinical trial. The study achieved its primary endpoint by demonstrating that ifetroban was safe and well tolerated in this patient population.

    在第二季,我們共同公布其第二期臨床試驗的正向結果。該研究達成主要終點,證明 ifetroban 在此患者族群中安全且耐受性良好。

  • In addition, the trial generated encouraging efficacy signals including fewer patients experiencing metastatic recurrence and fewer deaths related to metastasis in the ifetroban treatment arm when compared with placebos.

    此外,該試驗亦產生令人鼓舞的療效訊號;與安慰劑相比,ifetroban 治療組出現轉移復發的患者較少,且與轉移相關的死亡人數也較少。

  • We are pleased with the progress in this collaboration and look forward to working with our partners at Vanderbilt as we determine the next steps for this oncology program.

    我們對此合作的進展感到欣慰,並期待與 Vanderbilt 的合作夥伴共同研議此腫瘤學計畫的下一步。

  • Next, I'd like to briefly discuss Cumberland Emerging Technologies or CET.

    接下來,我想簡要談談 Cumberland Emerging Technologies(CET)。

  • CET remains an important strategic asset for Cumberland and plays a valuable role in identifying, supporting, and advancing innovative biomedical technologies originating from leading research institutions. Through CET, we continue to collaborate with academic investigators, healthcare institutions, and emerging life sciences companies to help translate promising scientific discoveries into potential therapeutic products. These activities complement our internal development efforts while expanding our access to innovative technologies that may strengthen Cumberland's pipeline and create additional opportunities for future growth.

    CET 仍是 Cumberland 重要的策略性資產,在辨識、支持並推進源自頂尖研究機構的創新生物醫學技術方面扮演關鍵角色。透過 CET,我們持續與學術研究者、醫療機構及新興生命科學公司合作,協助將具潛力的科學發現轉化為潛在治療產品。這些活動在擴大我們取得創新技術的同時,也與我們內部的開發工作相輔相成,並可能強化 Cumberland 的產品線,為未來成長創造更多機會。

  • Overall, we believe our portfolio of clinical development programs combined with our financial strength positions Cumberland exceptionally well for the future. I'll turn it back over to you now, AJ.

    整體而言,我們相信臨床開發計畫的組合,加上我們的財務實力,使 Cumberland 在未來具備極佳的定位。AJ,現在交回給你。

  • A. Kazimi - Chairman of the Board, Chief Executive Officer

    A. Kazimi - Chairman of the Board, Chief Executive Officer

  • Thanks, Todd. I'll next look to our Chief Financial Officer, John Hamm, for the financial update. John.

    謝謝你,Todd。接下來我請我們的財務長 John Hamm 提供財務更新。John。

  • John Hamm - Chief Financial Officer, Vice President

    John Hamm - Chief Financial Officer, Vice President

  • Thank you, AJ. I'll begin with a review of our financial results for the second quarter, followed by an update on the financial impact of our recently completed strategic transaction.

    謝謝你,AJ。我將先回顧我們第二季的財務結果,接著更新我們近期完成之策略性交易對財務的影響。

  • During the second quarter, we reorganized our income statement to classify revenue and expenses associated with the Apotex transaction as discontinued operations.

    在第二季期間,我們重新編列損益表,將與 Apotex 交易相關的收入與費用分類為停業單位(discontinued operations)。

  • Our ongoing investment in research and development supported by our remaining general administrative expenses resulted in an operating loss of $3.1 million for the quarter. With the addition of the discontinued operations, the net loss for the quarter was $4.1 million.

    我們持續投入研發,加上其餘一般及行政費用,使本季營業損失為 310 萬美元。加計停業單位後,本季淨損為 410 萬美元。

  • As of June 30, 2026, Cumberland had total assets of $63 million, including approximately $4 million in cash and cash equivalents. Please note that we retired our bank line of credit through a payment of $5.2 million at the end of the second quarter.

    截至 2026 年 6 月 30 日,Cumberland 的總資產為 6,300 萬美元,其中包括約 400 萬美元的現金及約當現金。請注意,我們於第二季末支付 520 萬美元以償還銀行循環信用額度。

  • Therefore, total liabilities were reduced to $46 million resulting in shareholders' equity of approximately $17 million at quarter end. The successful completion of our strategic transaction with Apotex Health marks a significant change in the company's financial profile.

    因此,總負債降至 4,600 萬美元,使季末股東權益約為 1,700 萬美元。我們與 Apotex Health 成功完成策略性交易,標誌著公司財務概況的重大變化。

  • The agreement closed on July 1st and therefore will further impact our financial statements in the third quarter. We received $100 million at closing and estimate the taxes associated with the transaction to be less than $1 million due to our tax loss carry forwards and R&D tax credits. The net proceeds, along with the $11 million in additional funds due over the next 12 months, will result in significant net proceeds from the transaction estimated at $108 million.

    該協議於 7 月 1 日完成交割,因此將在第三季進一步影響我們的財務報表。我們在交割時收到 1 億美元,並估計因我們的稅務虧損結轉(tax loss carry forwards)及研發稅額抵減(R&D tax credits),與該交易相關的稅負將低於 100 萬美元。淨收益加上未來 12 個月內應收的額外 1,100 萬美元資金,將使本交易的重大淨收益估計達 1.08 億美元。

  • In July, our board met and evaluated alternatives for this new capital. They declared a special dividend of $1.50 per share, which totalled $22 million based on the approximately 15 million shares outstanding.

    7 月,我們董事會召開會議並評估這筆新資本的替代方案。董事會宣告每股 1.50 美元的特別股利,按約 1,500 萬股流通在外股數計算,合計為 2,200 萬美元。

  • We believe that our strengthened cash position provides Cumberland with the financial flexibility to advance our clinical development programs, evaluate additional strategic opportunities, and support the company's long-term growth initiatives. We project that the remaining cash will fund company operations for over 5 years as we continue to invest in our new product candidates.

    我們相信,我們強化後的現金部位為 Cumberland 提供了財務彈性,可推進我們的臨床開發計畫、評估其他策略性機會,並支持公司的長期成長倡議。我們預估,在持續投資於新產品候選項目的同時,剩餘現金將可支應公司營運超過 5 年。

  • We also currently estimate significant additional cash reserves of over $50 million should be available for unexpected expenses and special opportunities that may arise. I'd also like to further discuss the accounting for the strategic transaction. Accordingly, our financial statements will differ meaningfully from prior periods as Cumberland transitions from a commercially oriented specialty pharmaceutical company to an innovation-focused biopharmaceutical company centred on product development. We will no longer be recording the revenue from the commercial brands nor the related expenses, which include cost of goods, sales and marketing.

    我們目前也估計,尚有超過 5,000 萬美元的可觀額外現金準備金,可用於可能出現的突發支出與特殊機會。我也想進一步說明這項策略性交易的會計處理。因此,隨著 Cumberland 從以商業化為導向的專科製藥公司轉型為以產品開發為核心、以創新為導向的生物製藥公司,我們的財務報表將與以往期間有顯著差異。我們將不再認列商業品牌的營收及其相關費用,包括銷貨成本、銷售與行銷費用。

  • As a reference, please note those expenses totalled nearly $32 million in 2025. It should be noted that future operating results will primarily reflect our investment in clinical development and regulatory activities supported by manufacturing and corporate administrative expenses and any future milestone or collaboration payments associated with our development programs. We expect the transaction to significantly strengthen our balance sheet while simplifying our ongoing operating structure. Looking ahead, Cumberland enters this next phase from a position of considerable financial strength. The proceeds from the transaction provide the resources necessary to advance our clinical pipeline while we maintain disciplined financial management. Our primary financial priorities remain clear.

    供參考,請注意這些費用在 2025 年合計接近 3,200 萬美元。需要指出的是,未來的營運結果將主要反映我們在臨床開發與法規活動上的投資,並由製造與公司行政管理費用支撐,以及與我們開發計畫相關的任何未來里程碑或合作款項。我們預期此交易將在簡化我們持續營運架構的同時,顯著強化資產負債表。展望未來,Cumberland 將以相當雄厚的財務實力進入下一階段。交易所得款項提供推進我們臨床產品線所需的資源,同時我們將維持嚴謹的財務管理。我們的主要財務優先事項依然明確。

  • First, officially funding the investment of our current development program.

    第一,正式為我們目前的開發計畫投資提供資金。

  • Second, maintaining a strong balance sheet and preserving financial flexibility. And third, continuing to maintain significant financial reserves for opportunities that can enhance shareholder value.

    第二,維持強健的資產負債表並保留財務彈性。第三,持續保有可觀的財務準備金,以把握能提升股東價值的機會。

  • Going forward, investors should increasingly evaluate Cumberland based on the advancement of our clinical pipeline, execution against key development milestones, and the management of the company's capital resources. Overall, we believe Cumberland is exceptionally well-positioned to execute on its strategy and create long-term value for shareholders. With that, I'll turn the call back over to you, AJ.

    展望未來,投資人應愈來愈以我們臨床產品線的推進、關鍵開發里程碑的執行,以及公司資本資源的管理來評估 Cumberland。整體而言,我們相信 Cumberland 具備極佳條件來落實其策略並為股東創造長期價值。接下來,我把電話交回給你,AJ。

  • A. Kazimi - Chairman of the Board, Chief Executive Officer

    A. Kazimi - Chairman of the Board, Chief Executive Officer

  • So, as you heard today, the successful completion of our strategic transaction marks a defining moment in Cumberland's evolution. With the completion of the transaction, we've sharpened our strategic focus, strengthened our financial position, and assembled an advanced clinical pipeline targeting serious diseases with significant unmet medical needs. With important multiple clinical milestones anticipated during the remainder of 2026. We believe we're entering one of the most exciting periods in our company's history.

    因此,正如各位今天所聽到的,我們策略性交易的成功完成,標誌著 Cumberland 演進過程中的一個決定性時刻。隨著交易完成,我們已聚焦策略重點、強化財務狀況,並建立了一條先進的臨床產品線,鎖定具有重大未被滿足醫療需求的嚴重疾病。並且在 2026 年剩餘期間預期將有多項重要的臨床里程碑。我們相信,我們正進入公司歷史上最令人振奮的時期之一。

  • For our Duchenne Muscular Dystrophy program, we'll continue our discussions with FDA as we define the regulatory pathway forward. For our systemic sclerosis program, we're completing the final analysis of our study data and look forward to announcing topline results this year. Patient enrolment in our idiopathic pulmonary fibrosis study is progressing very well, and we remain on track to report interim efficacy findings this year. And in addition, we'll continue evaluating opportunities to advance our oncology collaboration with Vanderbilt Health following the encouraging results from the recently completed metastases prevention study. These milestones represent opportunities to advance our development programs while continuing to build value for patients and shareholders alike.

    就我們的杜興氏肌肉失養症(Duchenne Muscular Dystrophy)計畫而言,我們將在界定未來法規路徑的同時,持續與 FDA 討論。就我們的系統性硬化症(systemic sclerosis)計畫而言,我們正在完成研究數據的最終分析,並期待於今年公布主要結果(topline results)。我們的特發性肺纖維化(idiopathic pulmonary fibrosis)研究之病患招募進展非常順利,我們仍按計畫於今年報告期中療效發現。此外,在近期完成的轉移預防研究取得令人鼓舞的結果後,我們將持續評估推進與 Vanderbilt Health 腫瘤合作的機會。這些里程碑代表推進我們開發計畫的機會,同時也持續為病患與股東建立價值。

  • Importantly, we now have the financial resources, organizational focus and experienced development team necessary to execute the strategy. We're working to bring differentiated therapies to patients with rare diseases and other serious medical conditions where treatment options remain limited.

    重要的是,我們現在具備執行該策略所需的財務資源、組織聚焦,以及經驗豐富的開發團隊。我們正致力於為罕見疾病及其他治療選項仍然有限的嚴重醫療狀況之病患,帶來具差異化的療法。

  • Before concluding, I would just like to once again thank our employees for their dedication throughout this transformational year. Their hard work has made a successful completion of our strategic transaction possible while ensuring continued progress across each of our development programs.

    在結束之前,我想再次感謝我們的員工在這個轉型年度中的投入與奉獻。他們的辛勤工作使我們得以成功完成策略性交易,同時確保我們各項開發計畫持續取得進展。

  • I would also like to thank our board of directors and shareholders for their continued confidence and support. We appreciate the trust you place in Cumberland as we begin our next chapter. We're excited about the opportunities that lie ahead and look forward to updating you on our continued progress.

    我也要感謝我們的董事會與股東持續的信任與支持。在我們開啟下一篇章之際,我們珍視各位對 Cumberland 的信賴。我們對未來的機會感到振奮,並期待向各位更新我們持續的進展。

  • Thank you again for joining us today. And so, with that, operator, let's now open the call for questions.

    再次感謝各位今天加入我們。那麼,接下來,接線員,現在請開放提問。

  • Operator

    Operator

  • Thank you, sir. Ladies and gentlemen, that concludes the company's presentation, and we will now open the call for any questions. (Operator Instructions). Please stand by while we compile our Q&A roster.

    謝謝您,先生。各位女士、先生,公司簡報到此結束,現在我們將開放提問。(接線員指示)。請稍候,我們將彙整問答名單。

  • A. Kazimi - Chairman of the Board, Chief Executive Officer

    A. Kazimi - Chairman of the Board, Chief Executive Officer

  • Well, there are no questions.

    嗯,沒有問題。

  • I just want to thank everybody for joining us for today's call and we do understand many of our shareholders prefer a private discussion with management. If so, please just reach out and we'll be happy to get such a call scheduled and have such a discussion.

    我只想感謝大家參加今天的電話會議,我們也理解許多股東偏好與管理團隊進行私下討論。若是如此,請直接與我們聯繫,我們很樂意安排通話並進行討論。

  • As always, we appreciate your time and interest in our company, and we look forward to providing another update in the coming months.

    一如既往,我們感謝各位對本公司的時間與關注,並期待在未來幾個月提供另一項更新。

  • Operator

    Operator

  • Thank you, sir. Ladies and gentlemen, that concludes today's call. If you would like to listen to a replay of the discussion, please visit the investor relations section on Cumberland's website. I would like to thank you for your participation. You may now disconnect.

    謝謝您,先生。各位女士、先生,今天的電話會議到此結束。若您想收聽本次討論的重播,請造訪 Cumberland 網站的投資人關係專區。感謝各位的參與。您現在可以掛線。