KORU Medical Systems Inc (KRMD) 2025 Q3 法說會逐字稿

Greetings, and welcome to KORU Medical Systems third quarter 2025 earnings conference call. (Operator Instructions) Please note this conference is being recorded. I will now turn the conference over to Louisa Smith, Head of Investor Relations. Thank you. You may begin.

各位好，歡迎參加 KORU Medical Systems 2025 年第三季財報電話會議。（操作員說明）請注意，本次會議正在錄音。現在我將把會議交給投資者關係主管路易莎史密斯。謝謝。你可以開始了。

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems; and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the third quarter ended September 30, 2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of them, which includes our financial results and commentary on the quarter.

謝謝接線員，大家下午好。今天與我一起參加電話會議的有 KORU Medical Systems 的總裁兼執行長 Linda Tharby，以及財務長 Tom Adams。今天早些時候，KORU 發布了截至 2025 年 9 月 30 日的第三季財務業績。新聞稿副本可在公司網站上查閱。我建議聽眾將我們的新聞稿放在手邊，其中包含我們的財務表現和季度評論。

Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website.

此外，我們將在今天的電話會議中使用幻燈片來輔助進一步的評論，這些幻燈片也可在我們網站的投資者關係部分找到。

During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements.

在本次電話會議中，我們將就我們的業務計劃和其他事項發表一些前瞻性聲明。這些評論是基於我們截至目前為止的預測和預期。由於存在風險和不確定性，實際事件或結果可能與預期有重大差異，包括相關新聞稿和我們最近向美國證券交易委員會提交的文件中提到的風險和不確定性。我們不承擔更新任何前瞻性陳述的義務。

During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation and SEC filings.

電話會議期間，管理階層也將討論一些非GAAP財務指標。您可以在我們的新聞稿、隨附的投資者演示文稿和提交給美國證券交易委員會的文件中找到更多披露信息，包括這些非GAAP指標與可比較GAAP指標的調節表。

For the benefit of those listening to the replay, this call was held and recorded on Wednesday, November 12, 2025, at approximately 4:30 PM Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Linda Tharby, President and CEO.

為了方便收聽重播的人，本次通話於 2025 年 11 月 12 日星期三下午 4:30 左右（美國東部時間）舉行並錄音。此後，該公司可能就討論的主題發表了其他評論。現在我想把電話交給總裁兼執行長琳達·薩比。

Linda, please go ahead.

琳達，請繼續。

Thank you, Louisa. Good afternoon, everyone, and thank you for joining today's earnings call. I'll begin with some commentary on our third quarter highlights and strategic progress, and then Tom will review our financial results before we open the call for questions. During the third quarter, we delivered strong results, accelerating revenue growth, outstanding performance in our core immunoglobulin business, new additions to our PST pipeline and continued progress towards sustained profitability. We achieved our second consecutive quarter with more than $10 million in revenue, representing 27% year-over-year growth.

謝謝你，路易莎。各位下午好，感謝各位參加今天的財報電話會議。首先，我將對我們第三季度的亮點和策略進展進行一些評論，然後湯姆將回顧我們的財務業績，之後我們將開放提問環節。第三季度，我們取得了強勁的業績，加速了收入成長，核心免疫球蛋白業務表現出色，PST產品線新增了產品，並持續朝著持續獲利的目標邁進。我們連續第二季營收超過 1,000 萬美元，較去年同期成長 27%。

The key growth driver was our core subcutaneous immunoglobulin or SCIg business, which grew 30%, driven by international expansion, continued global share gains and strong underlying patient growth. While we saw some quarterly shifts in purchasing patterns between domestic and international markets, both underlying businesses remain robust. Tom will provide additional details on the shift in geographic mix. From a strategic standpoint, we advanced several important initiatives this quarter. We recently announced two new PST collaborations, underscoring our commitment to expanding our pipeline, broadening our label and reaching additional patient populations.

主要成長動力來自我們的核心皮下免疫球蛋白（SCIg）業務，該業務增長了 30%，這得益於國際擴張、持續的全球市場份額增長以及強勁的潛在患者增長。雖然我們看到國內和國際市場的採購模式出現了一些季度性的變化，但這兩個市場的基本業務仍然保持強勁。湯姆將提供有關地域組成變化的更多細節。從策略角度來看，本季我們推進了幾項重要措施。我們最近宣布了兩項新的 PST 合作，這凸顯了我們致力於擴大產品線、拓展產品標籤並惠及更多患者群體的決心。

I'll share more detail on those collaborations during our pipeline discussion. We also made meaningful progress toward our goal of expanding into oncology infusion centers, successfully completing a US-based oncology study that validated KORU's value proposition in this market. We remain on track for a 510(k) filing by the end of 2025. On the financial front, we delivered gross profit growth of 21% year-over-year, achieved positive adjusted EBITDA and generated positive cash flow. To reflect our confidence in the business and continued execution, we are raising our full year revenue guidance to $40.5 million to $41 million, representing growth of approximately 20% to 22%, and we are reaffirming our guidance for gross margins and cash flow from operations.

我會在我們的專案規劃討論中分享更多關於這些合作的細節。我們在拓展腫瘤輸液中心的目標上也取得了實質進展，成功完成了一項在美國進行的腫瘤研究，驗證了 KORU 在該市場的價值主張。我們仍有望在 2025 年底前提交 510(k) 申請。在財務方面，我們實現了毛利年增 21%，調整後 EBITDA 為正，並產生了正現金流。為了體現我們對業務的信心和持續的執行力，我們將全年收入預期上調至 4,050 萬美元至 4,100 萬美元，成長約 20% 至 22%，同時重申我們對毛利率和經營現金流的預期。

Now turning to our US SCIg business, which represents our largest recurring revenue base. As shown on Slide 4, external forecasts project SCIg market growth of approximately 9% annually over the next five years, outpacing the IVIg segment. This growth outlook is supported by several key factors. First, an increasing number of new patients are being diagnosed and treated with SCIg as their first-line therapy.With approximately 20% market penetration today, SCIg still has significant headroom for expansion in the broader immunoglobulin therapy market.

現在讓我們來看看我們在美國的SCIg業務，這是我們最大的經常性收入來源。如投影片 4 所示，外部預測顯示，未來五年 SCIg 市場每年成長約 9%，超過 IVIg 市場。這一成長前景受到幾個關鍵因素的支撐。首先，越來越多的新患者被診斷出患有新冠肺炎，並接受皮下注射免疫球蛋白（SCIg）作為第一線治療方案。目前SCIg的市場滲透率約為20%，在更廣泛的免疫球蛋白治療市場中，它仍有很大的成長空間。

Second, we're seeing broader diagnosis of Secondary Immunodeficiency or SID, driven by an aging population, higher prevalence of chronic illnesses and increased use of immunosuppressive treatments such as chemotherapy and CAR T-cell therapy.

其次，由於人口老化、慢性疾病盛行率較高以及化療和 CAR T 細胞療法等免疫抑制治療的使用增加，我們看到繼發性免疫缺陷或 SID 的診斷範圍更廣。

Importantly, we're also seeing growing clinical activity in the SID area, which could ultimately support new reimbursement coverage and add further momentum to SCIg adoption. Finally, pharma partners continue to invest heavily in the SCIg space through device innovations such as prefilled syringes and a strong pipeline of clinical trials and label expansions. Our leadership position in this category remains very strong.

重要的是，我們也看到 SID 領域的臨床活動日益增多，最終可能會支持新的報銷範圍，並進一步推動 SCIg 的普及。最後，製藥合作夥伴繼續透過預充式註射器等設備創新以及強大的臨床試驗和標籤擴展計劃，對 SCIg 領域進行大量投資。我們在該領域的領先地位依然非常穩固。

US end user demand and sales to specialty pharmacies are at or above market growth rates, reflecting solid execution and the continued health and momentum of our US SCIg business.

美國終端用戶需求和對專科藥局的銷售額均達到或超過市場成長率，這反映了我們穩健的執行力以及美國 SCIg 業務的持續健康和發展勢頭。

Now turning to international, which continues to be one of the most exciting areas for our accelerated growth potential. Over the past year, we've grown our international market share from roughly 10% to 15% to 20% of the underlying $60 million OUS SCIg market.

現在轉向國際市場，這仍然是我們最具成長潛力的領域之一。過去一年，我們在國際市場上的份額從大約 10% 到 15% 再到 20% 增長到 6000 萬美元的美國境外免疫球蛋白 (OUS SCIg) 市場。

We see further growth potential in several key areas. First, the shift to prefilled syringes in Europe. This represented the majority of our growth this quarter. The efforts to convert a market from vials to prefilled syringes using our Freedom Infusion System, including both the pump and consumables, have been very successful. By simplifying administration steps, our system makes it easier for patients to use and for healthcare professionals to train them.

我們看到幾個關鍵領域還有進一步的成長潛力。首先是歐洲向預充式註射器的轉變。這佔了我們本季成長的大部分。我們使用 Freedom 輸液系統（包括幫浦和耗材）將市場從藥瓶轉向預灌封注射器的努力非常成功。透過簡化管理步驟，我們的系統使患者更容易使用，也使醫療保健專業人員更容易培訓他們。

Several additional EU countries are planning similar conversions and our innovation pipeline combined with strong alignment with pharma partners positions us well to further penetrate the top European markets. At the same time, we continue to grow infusion set sales in markets that still primarily use vials.

其他幾個歐盟國家也計劃進行類似的轉型，我們的創新產品線加上與製藥合作夥伴的緊密合作，使我們能夠更好地進一步打入歐洲頂級市場。同時，我們在仍主要使用藥瓶的市場中持續擴大輸液裝置的銷售量。

Overall, we feel very confident about our international momentum. We are targeting to accelerate our overall market share from the mid-teens into the 40% range, representing a $10 million to $20 million opportunity over the next several years. This next slide highlights our progress with Ig pharma partners.

整體而言，我們對自身的國際發展動能非常有信心。我們的目標是將整體市佔率從十幾個百分點提高到 40% 左右，這意味著未來幾年內將有 1,000 萬至 2,000 萬美元的商機。下一張投影片重點介紹我們與 Ig 製藥合作夥伴的進展。

Today, we have seven active collaborations across all four major Ig manufacturers, which continue to drive core growth alongside their new drug, device and indication expansion. Commenting on changes from last quarter, we saw two previously announced collaborations push their launch date into 2027. We have updated our pipeline accordingly. Importantly, we don't see this as having any material impact on current projected revenue. Highlighted in green on the bottom row is our most recent collaboration, which we announced last week.

目前，我們與四大免疫球蛋白製造商開展了七項積極的合作，這些合作在推動新藥、新設備和適應症擴展的同時，也持續推動核心業務的成長。與上個季度相比，我們看到先前宣布的兩項合作將發布日期推遲到了 2027 年。我們已據此更新了我們的流程。重要的是，我們認為這不會對目前的預期收入產生任何實質影響。底部一行以綠色突出顯示的是我們最新的合作項目，我們上週宣布了這個項目。

This is particularly exciting because the relationship with this drug manufacturer expands our potential into the broader patient populations for an Ig drug where we currently hold a lower global share position. Overall, these Ig collaborations are a key driver of both share gains and geographic expansion in the subcutaneous market, reinforcing our strategy of partnering with pharma companies to accelerate adoption and growth.

這一點尤其令人興奮，因為與這家製藥公司的合作關係擴大了我們在免疫球蛋白藥物領域（目前我們在全球市場份額較低）的潛力，使其能夠覆蓋更廣泛的患者群體。總體而言，這些 Ig 合作是皮下市佔率成長和地理擴張的關鍵驅動力，強化了我們與製藥公司合作加速產品普及和成長的策略。

Turning now to new drugs outside of Ig. We currently have nine active collaborations with four potential new drugs expected to be added to our system by the end of 2026. Recent updates to this pipeline are highlighted in green on the slide.

現在轉向免疫球蛋白以外的新藥。我們目前有九項積極的合作，預計到 2026 年底將有四種潛在的新藥加入我們的系統。該流程的最新更新已在幻燈片中以綠色突出顯示。

First, a rare disease candidate has been pushed by one quarter to Q1 2026 following FDA request for additional testing data. We do not expect this to materially impact our timeline or 2026 revenue opportunity. Second, we are seeing expanded commercial potential for an additional Empaveli indication, a prior clear drug, which we are currently supporting in Phase III trials.

首先，由於 FDA 要求提供更多測試數據，一種罕見疾病候選藥物的上市時間被推遲了一個季度，至 2026 年第一季。我們預計這不會對我們的時間表或 2026 年的收入機會產生實質影響。其次，我們看到 Empaveli 的另一項適應症（先前已明確適應症）的商業潛力正在擴大，我們目前正在支持其進行 III 期試驗。

Finally, we recently announced our collaboration with ForCast Ortho, supporting their clinical trials for treatments that address complications from joint replacement surgeries. This marks our first opportunity in the orthopedic space and adds approximately 140,000 potential infusions.

最後，我們最近宣布與 ForCast Ortho 展開合作，支持他們針對關節置換手術併發症的治療臨床試驗。這標誌著我們在骨科領域迎來了第一個機遇，並增加了約 14 萬次潛在的輸液機會。

We estimate that the non-Ig drugs in our pipeline with an anticipated launch date between now and 2027 have a commercial potential for KORU of up to $10 million by the end of 2028. With the clinical pipeline of more than 95 drugs exceeding 10 mls across the pharma landscape, we continue to actively pursue additional assets to expand and strengthen our pipeline.

我們估計，我們研發管線中預計在 2027 年之前上市的非 Ig 類藥物，到 2028 年底，將為 KORU 帶來高達 1000 萬美元的商業潛力。在整個製藥領域，我們擁有超過 95 種臨床研發管線藥物，銷量超過 1,000 萬毫升，我們將繼續積極尋求其他資產，以擴大和加強我們的研發管線。

This quarter, we also continued to advance our entry into the oncology infusion space. Currently, there are seven subcutaneous oncology drugs administered in infusion clinics using manual syringe push, which requires nurses to stand over patients and inject highly viscous drugs over a period of 5 to 10 minutes. Following our successful EU study, where 97% of nurses preferred the FreedomEdge infusion system over manual syringe administration, we launched a US pilot study in Q2, which concluded in Q3.

本季度，我們也持續推進進軍腫瘤輸液領域的腳步。目前，有七種皮下腫瘤藥物需要在輸液中心使用手動注射器推注的方式進行給藥，這需要護理師站在病人旁邊，在 5 到 10 分鐘內注射高黏度藥物。繼我們在歐盟成功進行研究之後（97% 的護理師更喜歡 FreedomEdge 輸液系統而不是手動注射器給藥），我們於第二季啟動了一項美國試點研究，該研究於第三季結束。

In total, five oncology infusion clinics participated, administering two leading oncology drugs. The results were very encouraging. We achieved a 100% success rate in administration and met all safety requirements. We also observed high satisfaction among nurses and patients with improvements in physical strain and patient comfort using the Freedom System compared to manual syringe push.

共有五家腫瘤輸液診所參與，使用了兩種領先的腫瘤藥物。結果非常令人鼓舞。我們在行政管理方面取得了100%的成功率，並滿足了所有安全要求。我們還觀察到，與手動注射器推注相比，使用 Freedom 系統可以減輕護理師和患者的體力消耗，並提高患者的舒適度，因此護理師和患者都非常滿意。

Importantly, 70% of nurses reported the ability to multi-task, including treating other patients, adding the potential for improved clinic workflow efficiency. Our value proposition continues to resonate across all sites studied. We are progressing in collaboration with one of the seven oncology drugs and remain on track for a 510(k) submission to the FDA, either in Q4 of this year, subject to federal timing or in Q1 2026, with anticipated commercial market entry in the second half of 2026.

值得注意的是，70% 的護理師表示能夠同時處理多項任務，包括治療其他病人，這增加了提高診所工作流程效率的潛力。我們的價值主張在所有研究地點持續引起共鳴。我們正在與七種腫瘤藥物中的一種進行合作，並繼續按計劃向 F​​DA 提交 510(k) 申請，要么在今年第四季度（取決於聯邦政府的時間安排），要么在 2026 年第一季度，預計將於 2026 年下半年進入商業市場。

The total addressable market for oncology infusion consumables is significant, projected to grow from approximately $60 million in 2025 to $138 million by 2030. We are being very diligent about our market entry and regulatory strategy, ensuring that when we enter oncology, we do so in a way that supports patients, providers and long-term growth.

腫瘤輸液耗材的總潛在市場規模龐大，預計將從 2025 年的約 6,000 萬美元成長到 2030 年的 1.38 億美元。我們正在非常認真地對待市場進入和監管策略，以確保我們進入腫瘤領域時，能夠支持患者、醫療服務提供者和長期發展。

Overall, I'm extremely proud of the team's execution and the strong momentum we built across our business during the first three quarters. With robust growth in our US and international markets, meaningful pipeline progress and strategic advances across both Ig and non-Ig opportunities, we're well positioned.

總的來說，我對團隊的執行力以及我們在前三個季度在整個業務中建立的強勁勢頭感到非常自豪。憑藉我們在美國和國際市場的強勁成長、在免疫球蛋白和非免疫球蛋白領域取得的顯著進展和戰略優勢，我們已處於有利地位。

With that, I'll turn the call over to Tom to review our financial results and share our updated guidance for 2025.

接下來，我將把電話交給湯姆，讓他回顧我們的財務表現並分享我們更新後的 2025 年績效指引。

Thanks, Linda. Starting with revenue. We are pleased to report our second consecutive quarter of revenue above $10 million with 27% year-over-year growth, which is a record high for KORU. We delivered 30% growth in our overall core business, reflecting the fundamental strength of the underlying demand for our products and KORU's growing market position. The geographic mix this quarter does require some context for which I'll provide some additional commentary.

謝謝你，琳達。首先從營收說起。我們很高興地宣布，該公司連續第二季營收超過 1,000 萬美元，年增 27%，創下 KORU 的歷史新高。我們的核心業務整體成長了 30%，這反映了市場對我們產品的基本需求強勁，以及 KORU 不斷成長的市場地位。本季度的地域構成需要一些背景信息，我將對此做一些補充說明。

Our reported domestic revenue declined 5%, while international revenue grew by 230%. There were three specific factors that drove this geographic shift in revenue imbalance across our businesses. First, in the domestic core business, as we discussed and anticipated on our previous call, one of our US distributors reduced their on-hand inventory levels this quarter, which temporarily impacted their order volume and moderated our domestic growth.

據報告，我們的國內收入下降了 5%，而國際收入則成長了 230%。導致我們各業務收入不平衡出現這種地域性轉變的具體因素有三。首先，在國內核心業務方面，正如我們在之前的電話會議中討論和預期的那樣，我們的一家美國分銷商在本季度減少了庫存水平，這暫時影響了他們的訂單量，並減緩了我們在國內的增長。

Second, in the International Core business, we had some outsized stocking orders to support the exceptionally strong demand we're seeing with prefilled conversions in Europe. We're encouraged by this momentum in PFS and believe that it will continue to be a meaningful driver of international growth moving forward.

其次，在國際核心業務方面，我們有一些超額庫存訂單，以支援我們在歐洲看到的預填充轉換方面異常強勁的需求。我們對 PFS 的這種發展勢頭感到鼓舞，並相信它將繼續成為未來國際成長的重要驅動力。

And third, one of our international distributors sold product to a US distributor, and that transaction had a dual effect. It inflated our international revenue figures while simultaneously reducing our domestic revenue growth. We have since corrected for this dynamic and do not anticipate it occurring again.

第三，我們的一家國際經銷商向一家美國分銷商出售了產品，而這筆交易產生了雙重影響。它虛增了我們的國際收入數據，同時降低了我們的國內收入成長。我們已經糾正了這一情況，預計不會再發生。

Altogether, we estimate that these three factors had an underlying impact of approximately $1.2 million between the two businesses. The bar chart on the right provides a visual to normalize for the imbalance we saw from these factors in the quarter.

總的來說，我們估計這三個因素對這兩家企業產生了約 120 萬美元的潛在影響。右側的長條圖提供了一個視覺化工具，用於消除本季由這些因素造成的失衡。

The bottom line here is that our core business is solid, end market demand is robust, we continue to grow our market position, and we are really pleased to have posted 30% overall core growth, which underscores the strength of our business on a global scale.

歸根結底，我們的核心業務穩健，終端市場需求強勁，我們的市場地位持續提升，我們非常高興地實現了 30% 的整體核心業務增長，這凸顯了我們業務在全球範圍內的實力。

Our Pharma Services and Clinical Trials businesses fluctuated slightly year-over-year due to the inherent nature of revenue recognition timing associated with the staging of work and milestones.

由於與工作分階段和里程碑相關的收入確認時間的固有性質，我們的醫藥服務和臨床試驗業務同比略有波動。

Moving on to gross margin. We continue to consistently deliver margins greater than 60%. This quarter, we reported a gross margin of 60.2%, a decrease of 320 basis points from the prior year period, driven primarily by a combination of higher manufacturing costs and lower yields, geographical customer mix from the strength of our international business and tariff impacts of approximately 50 basis points.

接下來分析毛利率。我們持續保持著60%以上的利潤率。本季度，我們的毛利率為 60.2%，比上年同期下降了 320 個基點，主要原因是製造成本上升和良率下降、國際業務強勁導致的地域客戶結構變化以及關稅影響（約 50 個基點）。

Looking ahead to the fourth quarter, we expect the cost of manufacturing to improve. And as we have indicated throughout the year, we will continue to see a higher mix of growth in our international markets with lower ASPs and a modest tariff impact from our suppliers. We reiterate and expect our full year margin to stay in line with our guidance of 61% to 63% as we have laid out since the start of the year.

展望第四季度，我們預計製造成本將有所改善。正如我們全年所指出的那樣，我們將繼續看到國際市場成長幅度更大，但平均售價會降低，供應商的關稅影響也會較小。我們重申並預計，全年利潤率將與我們年初以來設定的 61% 至 63% 的預期保持一致。

We finished this quarter with $8.5 million in cash, representing cash generation of $400,000, which was driven by lower net losses from higher revenues and disciplined operating expense spending. Additionally, our working capital was balanced, and we saw lighter investments in manufacturing equipment.

本季末，我們持有現金 850 萬美元，現金流入 40 萬美元，這得益於收入增加帶來的淨虧損減少以及嚴格的營運支出。此外，我們的營運資金保持平衡，並且我們在生產設備方面的投資也減少了。

Our non-cash items were primarily driven by stock comp expenses and depreciation. We continue to see the benefits of our discipline in our cash flow results. Our year-to-date financial highlights show that we are progressing towards profitability.

我們的非現金項目主要由股權激勵費用和折舊驅動。我們的現金流業績持續反映了我們嚴謹作風帶來的益處。今年迄今為止的財務亮點表明，我們正朝著獲利目標穩步前進。

Revenue grew 22% to $30.2 million compared to $24.8 million in the prior year first three quarters, with a corresponding operating expense increase of 3%, demonstrating our ability to run a disciplined capital allocation process. Gross margin remains over 60% at 62.1% despite some Q3 headwinds with manufacturing costs and tariff impacts. We cut net losses in half from $4.5 million to $2.2 million, and we have delivered positive adjusted EBITDA this year, showing a 109% improvement.

與上年同期相比，前三個季度的收入成長了 22%，達到 3,020 萬美元，而上年同期為 2,480 萬美元；相應的營運支出增加了 3%，這表明我們有能力執行嚴格的資本配置流程。儘管第三季受到製造成本和關稅影響等不利因素的影響，毛利率仍維持在 60% 以上，達到 62.1%。我們將淨虧損從 450 萬美元減少到 220 萬美元，今年實現了正的調整後 EBITDA，增幅達 109%。

As it relates to the balance sheet, our cash usage has dropped to $1.1 million year-to-date, representing a 60% decrease from last year. Looking ahead for the full year 2025, we are raising our revenue guidance to $40.5 million to $41 million, representing a 20% to 22% growth, an increase from our prior range of $39.5 million to $40.5 million.

就資產負債表而言，我們今年的現金使用量已降至 110 萬美元，比去年減少了 60%。展望 2025 年全年，我們將營收預期上調至 4,050 萬美元至 4,100 萬美元，成長 20% 至 22%，高於我們先前預期的 3,950 萬美元至 4,050 萬美元。

This is driven by opportunities for further growth internationally and a strong SCIg market in which we will continue to gain new patient starts. We are reiterating our gross margins in the range of 61% to 63% as well as reiterating our positive cash flow from operations. We expect to end the year with at least $8.2 million in cash.

這主要得益於國際市場進一步成長的機會以及強勁的皮下注射免疫球蛋白市場，我們將繼續在這個市場中獲得新的患者。我們重申毛利率在 61% 至 63% 之間，並重申經營活動產生的現金流量為正。我們預計年底至少會有 820 萬美元的現金。

I'll now turn the call over to Linda for some closing commentary on future milestones and our vision for continued growth.

現在我將把電話交給琳達，請她對未來的里程碑和我們持續發展的願景做一些總結性評論。

Thank you, Tom. We are making strong strides across our strategic priorities, setting the stage for accelerated revenue growth. In our efforts to expand the number of drugs on our Freedom System, this year-to-date, we have advanced four new pharmaceutical collaborations and submitted a 510(k) for our rare disease infusion drug.

謝謝你，湯姆。我們在各項策略重點領域都取得了顯著進展，為加速收入成長奠定了基礎。為了擴大我們自由系統中的藥物數量，今年迄今為止，我們已經推進了四項新的製藥合作，並提交了我們罕見疾病輸液藥物的 510(k) 申請。

Upcoming 510(k) filings in early 2026, including opportunities in oncology, position us for meaningful pipeline and commercial growth. In our international expansion efforts, we launched commercial sales in Japan and rolled out our Phase I flow controller.

2026 年初即將提交的 510(k) 文件，包括腫瘤學領域的機會，使我們在產品線和商業成長方面佔據了有利地位。在國際擴張過程中，我們在日本啟動了商業銷售，並推出了我們的第一階段流量控制器。

Growth in our top 10 markets will be further driven by prefilled conversions, expanding our global footprint and patient reach. Our core domestic SCIg franchise continues to outpace the market's 8% to 10% growth. With key submissions ahead, including the Phase II flow controller and next-gen Ig pump, we are poised to expand our SCIg leadership.

我們將透過預填充轉換率的提高、擴大全球業務範圍和患者覆蓋率，進一步推動前十大市場的成長。我們的核心國內SCIg特許經營業務持續超過市場8%至10%的成長速度。隨著包括二期流量控制器和下一代免疫球蛋白泵在內的關鍵產品即將提交，我們已準備好擴大我們在皮下注射免疫球蛋白領域的領先地位。

Overall, these achievements, combined with upcoming milestones, reinforce our confidence in meeting 2025 financial targets and sustaining long-term momentum. In summary, I'll leave you with some of the core elements we believe make KORU an attractive opportunity, not only now, but also in the future.

總體而言，這些成就，加上即將到來的里程碑，增強了我們對實現 2025 年財務目標和維持長期發展勢頭的信心。總而言之，我將向大家介紹我們認為使 KORU 成為一個有吸引力的機會的一些核心要素，不僅現在如此，將來也是如此。

Market dynamics continued to support a shift towards subcutaneous delivery, and our technology is well positioned to capture the benefits of that shift. Each quarter, we make great strides in executing against our plan. We achieved another excellent quarter with revenue expansion exceeding 25%, driven by steady recurring revenue from our core Ig franchise, ongoing patient base expansion with a compelling opportunity for growth acceleration internationally with prefill conversions.

市場動態持續推動皮下給藥方式的轉變，而我們的技術已做好充分準備，能夠從中受益。每個季度，我們在執行計劃方面都取得了巨大進步。我們又取得了一個非常出色的季度業績，收入增長超過 25%，這得益於我們核心 Ig 業務的穩定經常性收入，以及患者群體的持續擴大，同時預填充轉換也為國際市場帶來了令人振奮的增長加速機會。

Additionally, we have a robust and growing pipeline, including 11 new opportunities to bring new drugs outside of Ig onto our label in the coming years. And finally, our updated guidance underscores our confidence in continuing to accelerate revenue growth in 2025 and beyond while maintaining a healthy P&L and improving balance sheet to optimize flexibility and support with our growth strategies moving forward.

此外，我們擁有強大且不斷增長的產品線，包括在未來幾年內將 11 個新的機會，將免疫球蛋白以外的新藥納入我們的產品標籤。最後，我們更新的業績指引強調了我們有信心在 2025 年及以後繼續加速收入成長，同時保持健康的損益表並改善資產負債表，以優化靈活性並支持我們未來的成長策略。

Before closing, I'd like to thank the entire KORU team for their continued efforts and passionate work to further our mission and treat even more patients worldwide. Operator, please open the line for questions.

在結束之前，我要感謝 KORU 團隊全體成員的持續努力和熱情工作，以推進我們的使命，為世界各地更多的患者提供治療。接線員，請開通提問線。

(Operator Instructions)

（操作說明）

Frank Takkinen, Lake Street Capital Market.

弗蘭克‧塔基寧，湖街資本市場。

Great, thanks for taking the questions. Congrats on all the progress. I was hoping to start with the oncology setting. Happy to hear the pilots done and you had some great outcomes there. I think I heard you comment on the nurse feedback has been particularly positive with the ability to service a few patients at once. Maybe a little bit deeper into that would be helpful to understand how that feedback has been.

太好了，謝謝你回答這些問題。祝賀你們取得的所有進展。我原本希望從腫瘤科開始。很高興聽到試飛已經完成，而且你們取得了不錯的成果。我想我聽到您提到，護理師們對能夠同時服務多名患者給予了特別正面的回饋。或許更深入了解這些回饋會有所幫助。

And then as a second part in the oncology setting, can you maybe talk about the reimbursement model? Any work that needs to be done there or is there currently a structure in place that would be conducive to adoption in that setting?

其次，在腫瘤學領域，您能否談談報銷模式？那裡還需要做哪些工作？或者目前是否存在有利於在那種環境下進行收養的機制？

Thanks, Frank. Obviously, we're very excited about oncology being a major expansion into a new market for KORU. So the clinical study that we did was really based in five clinics in the US, we had very large centers and much smaller regional centers. So we had good diversity in terms of that.

謝謝你，弗蘭克。顯然，我們對腫瘤學成為 KORU 進入新市場的重大擴張感到非常興奮。因此，我們進行的臨床研究實際上是在美國的五家診所進行的，我們有一個規模很大的中心，也有規模小得多的區域中心。所以在這方面，我們的多樣性做得很好。

But the outcomes across all the clinics were fairly synonymous. So a glide quickly passed nursing and patient satisfaction, very, very high in the 90%-plus range. Obviously, the safe dosing of all of those drugs. Your specific question on workflow efficiency was the one that we were really excited about where 70% of nurses reported the ability to multi-task. So right now, they are completely wed to that patient with the manual syringe push administration.

但所有診所的治療結果都大同小異。因此，護理和患者滿意度迅速提升，非常非常高，達到 90% 以上。顯然，所有這些藥物的安全劑量都很重要。您提出的關於工作流程效率的具體問題讓我們非常興奮，因為 70% 的護理師表示能夠同時處理多項任務。所以目前，他們完全依賴手動注射器推注給藥方式來治療病人。

So what we were hoping to validate was that by using our pump, the clinic could see improved throughput of patients. And indeed, what we saw was that many nurses were comfortable being able to leave that patient and attend to other patients, do administrative duties, et cetera. So really huge opportunities for these clinics. On your last part around reimbursement, the great news is we don't have anything to do on the reimbursement front. The reimbursement codes that exist today cover for the administration of these drugs in infusion clinics using a pump.

所以我們希望驗證的是，透過使用我們的泵，診所可以提高患者的接診量。事實上，我們看到很多護士都樂於離開那位病人，去照顧其他病人、處理行政事務等等。所以這些診所真的有很多巨大的發展機會。關於您最後提到的報銷問題，好消息是我們在報銷方面沒有任何工作要做。現有的報銷代碼涵蓋了在輸液診所使用輸液幫浦進行這些藥物的給藥。

So that reimbursement coverage exists for the products. And so we're very excited about the opportunity. Charging ahead now to -- we've been doing the work to get the submission completed, provided that everything gets passed. We hope that the FDA will be receiving that submission. We're confident by the end of this year, and we're looking forward to what's ahead for us in the oncology market.

因此，這些產品可以獲得報銷。因此，我們對這個機會感到非常興奮。現在正全力推進——我們一直在努力完成提交工作，前提是所有環節都能通過。我們希望FDA能夠收到這份申請。我們對今年年底充滿信心，並期待腫瘤市場未來的發展。

That’s great. And then maybe a clarifier on guidance for Q4. Any color you can provide on kind of breakout of revenues per line item would be helpful just given the volatility from the different stocking dynamics and distributor dynamics. And then maybe if I can squeak one more. Any initial thoughts on 2026 would be helpful for us as we're building out our models for that year.

那太好了。然後或許還需要對第四季業績指引進行一些澄清。鑑於庫存動態和經銷商動態的波動性，如果您能提供按產品類別劃分的收入明細，將會很有幫助。然後，也許我還能再擠出一個。對於我們正在建立2026年模型的任何初步想法都將對我們有所幫助。

Okay. So maybe I'll start with the remainder of the year this year, and then I'll turn it over to Tom to give you some more specifics. So overall, if you look at our front half performance for the business, we grew 19% overall for the business with back half growth implied at the midpoint of our guidance at 23%. So that's the first thing is everybody should feel comfortable about the acceleration in revenues between the front and the back half. As for the split between business and what you can expect given the dynamics of the Q3, I'll let Tom go ahead.

好的。所以，我先從今年剩下的時間說起，然後交給湯姆，讓他給更具體的建議。總的來說，如果你看一下我們上半年的業務表現，我們整體業務成長了 19%，下半年的成長預期為我們預期的中點，為 23%。所以首先，大家應該對上半年和下半年營收加速成長感到放心。至於業務發展與第三季情勢發展之間的差距，我將讓湯姆來解答。

Yeah, thanks, Frank, for the question. If you look at our first half of the year and you look at that split, we split around 70% or so for the US business and around 23% to 24% for the international business. So you can assume that sort of split for the Q4 expectation on revenue.

好的，謝謝你的提問，弗蘭克。如果你看我們上半年的業績，再看看這個比例，你會發現美國業務佔了約 70%，國際業務佔了約 23% 到 24%。所以你可以假設第四季營收預期會呈現這種比例。

With the remainder of that obviously being the PST business. And then regarding 2026 guidance. So first thing I want to say is, obviously, when you post 220%-plus quarters in a row, we feel great and excited about the position that we're in. So if you look back over what we've been talking about for pretty much the course of the last year, it's taking the company to this new level of sustainable plus 20% growth. So while I'm not comfortable giving exact guidance for 2026, what I can say is that a number that starts with the two is something we're feeling good about at this moment in time.

剩下的部分顯然就是 PST 業務了。然後是關於 2026 年的指導意見。首先我想說的是，很顯然，當你連續幾個季度業績成長超過 220% 時，我們對我們所處的地位感到非常滿意和興奮。所以，回顧我們過去一年來一直在討論的內容，它正將公司帶入一個全新的、可持續成長超過 20% 的水平。因此，雖然我不方便對 2026 年做出確切的預測，但我可以說的是，目前我們對以 2 開頭的數字感到樂觀。

Obviously, we're looking for those accelerations, which opportunities from prefills, more international expansion, oncology, those new drugs, all of those things, the 20%-plus you're seeing today is being done without those things. So obviously, acceleration, whether that comes in '26, later in '26, early in '27. But that's what I would say that the number of starting in the two is what we're comfortable with today given what we know today.

顯然，我們正在尋找這些加速發展的機會，例如預填充、更多國際擴張、腫瘤學、新藥等等，而你今天看到的 20% 以上的增長是在沒有這些因素的情況下實現的。所以很明顯，加速發展，無論是在 2026 年、2026 年晚些時候還是 2027 年年初。但我認為，根據我們目前掌握的信息，這兩個位置的首發人數是我們現在比較滿意的。

Yes, got it. Makes a lot of sense. Thank you.

是的，明白了。很有道理。謝謝。

Caitlin Roberts, Canaccord Genuity.

Caitlin Roberts，Canaccord Genuity。

Hi, thanks for taking the questions and congrats on a great quarter. Just starting with the EU, I think you noted that several countries are preparing for the change to PFS. I mean, any more color on the size of those opportunities and potentially the timing of those?

您好，感謝您回答問題，並祝賀您本季取得了優異的成績。就歐盟而言，我認為您已經注意到，一些國家正在為績效付費模式的轉變做準備。我的意思是，能否提供更多關於這些機會的規模以及可能的時間安排的資訊？

So thank you, Caitlin, and congratulations on the new last name. Thank you, though, for the quarter. We're very excited about the international expansion opportunity. As I mentioned on the call, we see international taking our share position, pretty much doubling it over the next little bit, and we see that as a $10 million to $20 million opportunity overall, most of it being driven by prefills. We have converted just one large market.

所以，謝謝你，凱特琳，也恭喜你擁有了新的姓氏。不過，還是要謝謝你這季的付出。我們對國際擴張的機會感到非常興奮。正如我在電話會議上提到的，我們預計國際市場將佔據我們的市場份額，並在接下來的一段時間內幾乎翻一番，我們認為這將帶來 1000 萬至 2000 萬美元的整體機會，其中大部分將由預填充業務推動。我們只轉化了一個大型市場。

And why this opportunity is such a big lift for KORU is that the standard of care in Europe has been electronic pumps. Our studies in head-to-head show a 50% reduction in the number of steps required for patients to use our system versus electronic pumps. And also, it's easier for healthcare professionals to train. So I'm not going to give details of what the next countries are. But suffice to say that we've only got one down, and we think we have a lot of headroom in front of us with a lot of work to do, but it is a major growth opportunity and we're putting a lot of effort into that today.

對 KORU 來說，這次機會意義重大，因為歐洲的標準護理方式一直是使用電子幫浦。我們的直接對比研究表明，與電子幫浦相比，患者使用我們的系統所需的步驟減少了 50%。而且，醫護人員也更容易接受訓練。所以我不會透露接下來是哪些國家。但可以肯定的是，我們目前只完成了一個項目，我們認為前面還有很多工作要做，還有很大的發展空間，但這是一個重要的成長機會，我們目前正在為此投入大量精力。

That's great. And then obviously, share gains have been a big piece of the SCIg growth for you. But any color on the -- just market growth dynamics at this point in the year, maybe with early flu season starting and how you feel about that going into the end of the year and into 2026?

那太棒了。顯然，市場份額的成長對 SCIg 的成長起到了很大的作用。但對於今年的市場成長動態，以及流感季提前到來，您有什麼看法？您認為這種情況會持續到年底以及2026年嗎？

Yeah, So just overall, the -- what we've seen is the underlying rate of patient diagnosis is going up. I would say we've seen definite acceleration quarter-to-quarter. It's a little early yet. Usually, the diagnosis lags a couple of months by the infection.

是的，總的來說，我們看到的是患者診斷率正在上升。我認為我們已經看到季度環比明顯加速成長。現在還為時過早。通常情況下，感染發生後幾個月才能確診。

So while flu season starts, usually, these patients require four, five, six infections before their PID may be diagnosed. So we'll wait and see. But fingers crossed on that one. We've had a strong year thus far. I would say, the second dynamic, which I introduced in the call today, was we're seeing a lot more SID, Secondary Immunodeficiency with general underlying dynamics like aging populations, et cetera, driving it.

因此，雖然流感季節開始了，但通常情況下，這些患者需要感染四、五、六次流感才能確診原發性免疫缺陷症。所以我們會拭目以待。但願如此。今年到目前為止，我們的業績非常強勁。我想說，我在今天的電話會議中提出的第二個動態是，我們看到越來越多的繼發性免疫缺陷（SID）病例，其背後有人口老化等一般潛在動態因素在驅動。

But the big one is the cancer treatments. The chemotherapy drugs, the CAR T-cell therapies that reduce the immune system by design so that those drugs can work, then the patient needs immunotherapy. So we see a lot of the Ig manufacturers now starting trials for SID, because currently, that is not reimbursed in the US. So we see this as being a potential today that's not built into our numbers. That's probably a story that plays more into 2027 by the time they complete those trials. But we're certainly seeing a lot of off-label use of SID today.

但最大的問題是癌症治療。化療藥物、CAR-T細胞療法（透過抑制免疫系統來發揮療效）之後，患者還需要接受免疫療法。所以我們看到很多免疫球蛋白製造商現在開始進行SID試驗，因為目前在美國，SID治療不予報銷。所以我們認為這是目前尚未納入我們統計數據的潛在可能性。到 2027 年他們完成那些試驗時，這或許會成為更重要的故事。但我們現在確實看到了許多 SID 的非適應症使用情況。

Joseph Downing, Piper Sandler.

約瑟夫·唐寧，派珀·桑德勒。

Hey guys, thanks for taking the question. I'm for Jason today. Just a quick question on gross margin looking to 4Q and then into '26 as well. I know you're probably not too keen on divulging any specifics here. But just directionally, can you provide any commentary on how we should expect gross margin to develop here over the next, call it, 12 to 18 months? I know there's international mix dynamics, some manufacturing efficiencies, tariffs, some pricing, new launches, things like that.

各位，謝謝你們回答這個問題。我今天支持傑森。我有個關於毛利率的小問題，想了解一下第四季以及2026年的情況。我知道你可能不太願意在這裡透露任何細節。但就方向而言，您能否對未來 12 到 18 個月內毛利率的發展趨勢提供一些看法？我知道有國際市場格局變化、一些生產效率問題、關稅問題、一些定價問題、新產品發布等等。

But any color there would be really helpful.

但任何顏色都會很有幫助。

Yeah, hi, Joseph, thanks for the question. Yes. So as we mentioned, just starting with this year, we have seen that geographic mix change. And obviously, the geographic mix change when you think about the ASPs in the different markets as you grow more internationally, you have a lower ASP driven by emerging markets or established markets. But when you think about that dynamic and you accelerate that into the next 12 to 18 months, we are doing our best to hold our margins.

嗨，約瑟夫，謝謝你的提問。是的。正如我們之前提到的，從今年開始，我們已經看到地理組成發生了變化。顯然，隨著國際業務的成長，不同市場的平均售價（ASP）也會發生變化，新興市場或成熟市場的平均售價較低。但考慮到這種動態，並將其加速到未來 12 至 18 個月，我們正在盡最大努力保持利潤率。

We are always working on our cost and manufacturing with our operational excellence programs to identify opportunities driven by volumes, right, because we're a growing business. So we will continue to work on our margin profile. We have long-range plans to get our margins 65%-plus. So that is our strategy and that we will continue to focus on as we grow international.

我們一直在透過卓越營運計劃來改進成本和製造工藝，以尋找由銷售驅動的機會，因為我們是一家不斷發展的企業。因此，我們將繼續努力改善我們的利潤率狀況。我們有長遠計劃，目標是將利潤率提高到 65% 以上。這就是我們的策略，也是我們拓展國際市場時將持續重點關注的策略。

And maybe just to add on to what Tom said. Obviously, we started the year with the 61% to 63% margin range with a couple of manufacturing issues. The growth in international, which we did not anticipate -- we knew it was going to be good, but as good as it is growing through the year I think, Tom, we're probably doubled that business through the third quarter already.

也許可以補充一下湯姆剛才說的話。顯然，年初時我們的利潤率在 61% 到 63% 之間，但遇到了一些生產方面的問題。國際業務的成長是我們始料未及的——我們知道它會很好，但沒想到它會在整個年度持續成長，湯姆，我認為，到第三季度，我們的業務量可能已經翻了一番。

So the fact that we're able to maintain that original margin gain, also -- sorry, I forgot tariffs as well. Just a huge credit to our operations teams who have really done a great job of bringing back some efficiencies, which is why we're still confident despite those things, holding on to that 61% to 63% and continued march towards that 65% range that we're headed for over the next three to four years.

所以，我們能夠維持原有的獲利成長，還有──抱歉，我忘了關稅也算在內。這主要歸功於我們的營運團隊，他們確實在提高效率方面做得非常出色，正因如此，儘管存在這些情況，我們仍然充滿信心，能夠保持 61% 到 63% 的效率，並繼續朝著未來三到四年內我們設定的 65% 的目標邁進。

Great. I appreciate that, guys. And then one quick one on Japan. Can you just give us any color on maybe like the cadence of the ramp into next year? That would just be helpful for -- as we look at our models here.

偉大的。謝謝你們。然後簡單說說日本。能否透露一下明年發展趨勢的大致狀況？這對於我們在這裡查看模型會很有幫助。

Sure. So on Japan, I would say, the great news is we're in the market. We've got sales. I think I said this year, the sales would be somewhere just $300,000 to $500,000. I think we're feeling pretty good about that range.

當然。所以就日本市場而言，我認為最大的好消息是我們進入了日本市場。我們有促銷活動。我想我說過，今年的銷售額大概在 30 萬到 50 萬美元之間。我認為我們對這個範圍相當滿意。

Japan is primarily today an in-hospital system. And so we think it will take a little bit longer for Japan to evolve. But I would say, the overarching comment on international that has more than made up for that is the strength of the prefills. So we're excited still about Japan. And now I would say it's come -- it's still a growth driver, but it's probably now number three or number four on our list versus the broader prefill opportunity is number one by and large.

日本目前主要採用院內治療系統。因此，我們認為日本的發展還需要更長的時間。但我認為，國際市場最大的亮點在​​於預填充功能的強大，這足以彌補上述不足。所以我們仍然對日本充滿期待。現在我會說，它仍然是成長的驅動力，但它現在可能在我們名單上的排名第三或第四，而更廣泛的預填機會總體上是第一位的。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克，克雷格-哈勒姆。

Good afternoon. Congrats on the nice quarter here. Maybe just to start on US core. So just to clarify, I guess, a couple of things. So that $1.2 million was basically adjusting for those ordering dynamics from OUS distributor to US distributor. And then that would make US growth, call it, 14% kind of year-over-year if we add that $1.2 million there. And then maybe just give us an update on what SCIg growth was from a market perspective in the third quarter.

午安.恭喜你們本季業績不錯。或許可以先從美國核心內容著手。所以，我想澄清幾點。因此，這 120 萬美元基本上是對從美國境外分銷商到美國分銷商的訂購動態進行調整。如果加上這 120 萬美元，那麼美國的年增長率將達到 14% 左右。然後或許可以跟我們介紹一下 SCIg 在第三季的市場成長情況。

So thank you, Chase. Yes, we're excited about the quarter and appreciate the well wishes. The order dynamics, I think Tom laid them out well, and you got it perfectly. It's a combination. The only thing I would correct, yes, it's the $1.2 million that should have been in the US.

所以，謝謝你，蔡斯。是的，我們對本季充滿期待，並感謝大家的美好祝福。關於訂單動態，我認為湯姆已經闡述得很好了，你完全理解了。這是兩者的結合。我唯一要糾正的是，那120萬美元本來應該在美國。

That was a combination of three things, right? It was the stocking deceleration from one of our major US distributors and then also the order dynamic between the US and OUS. Regarding the broader SCIg market growth, we don't have the numbers yet for Q3.

那是由三件事共同造成的，對吧？這是由於我們的一家美國主要分銷商的庫存增速放緩，以及美國和美國境外之間的訂單動態變化所致。關於更廣泛的SCIg市場成長情況，我們目前還沒有第三季的相關數據。

Those usually lag a couple of months behind for us. But we know that from quarter one and quarter two that, that number was in that 8% to 9% range overall with acceleration between quarters in the growth levels being driven by PID, just really strong demand and patient growth in PID and then also the SID piece that I mentioned earlier.

對我們來說，這些通常會滯後幾個月。但我們知道，從第一季和第二季來看，這個數字總體上在 8% 到 9% 的範圍內，季度之間的成長加速是由 PID 推動的，PID 的需求非常強勁，患者數量增長也很快，還有我之前提到的 SID 部分。

Got it. Maybe just -- you noted some stocking related to the prefilled conversion in Europe as well. Can you just maybe speak to whether or not this is a new geography or the same one that we were talking about last quarter? And then I know you don't want to give specifics as far as the geographies that you expect kind of these rollouts prefilled conversions to take in. But can you maybe just give us your overall thoughts as far as how you see the cadence?

知道了。或許只是—您也注意到歐洲有一些與預填轉換相關的庫存。您能否說明一下，這是否是一個全新的地理區域，還是與我們上個季度討論的是同一個區域？我知道你不想透露你預期這些預填充轉換率推廣活動將涵蓋的特定地理範圍。但您能否就節奏方面，談談您的整體看法？

Is this going to be something that's a phase-in kind of country by country and it happens over the course of the next 18 to 24 months or just give us your overall thoughts there on the cadence?

這會是一個分階段、逐國實施的過程，需要18到24個月的時間才能完成嗎？還是請您就實施進度給出一個整體想法？

So one thing I should have mentioned on the last call, you said the 14% growth. And I think, yes, that's about right, the number for the US market. So regarding prefilled syringes and the first country, that country was a country that was dominated by electronic pumps.

所以，上次通話時我應該提到一件事，您提到了 14% 的成長率。是的，我認為這個數字差不多是對的，這是美國市場的數字。所以，關於預充式註射器和第一個國家，那個國家是電子幫浦主導的國家。

We had very low share positions in that market with our consumables, and they converted very quickly. They delisted their vials completely in that market and went 100% to prefills. And we were very fortunate to -- they did that pretty rapidly. We still see some upside in that market because the pharma company continues to win new tenders based on their prefills. So that's great news.

我們在該消費品市場的份額非常低，但他們很快就轉換了。他們完全停止在該市場上銷售瓶裝產品，100%轉向預填充產品。我們非常幸運——他們很快就做到了。我們仍然看到該市場存在一些上漲空間，因為這家製藥公司憑藉其預灌封產品不斷贏得新的招標項目。這是個好消息。

Regarding the cadence for prefills, we believe that the manufacturer that we're working with will complete most of the work in the major markets by the end of 2026. They are being quite aggressive as they see it to be a competitive advantage for them today. And what I would say is that the decision-making though is done on a country-by-country basis. So reimbursement is different, how the patient receives the product is different. So we've got a lot of work to do with each of those country leaders to ensure that we work with them on very specific go-to-market plans to make sure that the patient experience and the health care professional experience is what we all want it to be.

關於預填充產品的進度，我們相信與我們合作的製造商將在 2026 年底前完成主要市場的大部分工作。他們採取了相當激進的策略，因為他們認為這對他們目前的競爭優勢至關重要。我想說的是，決策是按國家逐一進行的。因此，報銷方式不同，患者獲得產品的方式也不同。因此，我們需要與每個國家的領導人進行大量工作，以確保我們與他們合作制定非常具體的市場推廣計劃，以確保患者體驗和醫療保健專業人員體驗能夠達到我們所有人的預期。

So we think most of the opportunity will be over the next 24 months in total for that opportunity.

因此，我們認為大部分機會將在未來24個月內出現。

Got it. Makes sense. Maybe just sneak one last one in, just to kind of check the box. I mean, this dynamic with the OUS distributor to the US distributor, that kind of cross-geography ordering, how are you able to confirm -- I mean, how are you able to make sure it doesn't happen again?

知道了。有道理。或許可以偷偷再加一個進去，就當是完成了一項任務。我的意思是，這種從美國境外分銷商到美國分銷商的跨地域訂購動態，你們如何確認——我的意思是，你們如何確保這種情況不再發生？

So I'll start and then maybe see if Tom wants to add anything. So we -- and by the way, right, in my career in this space, it's not the first time I've seen something like this happen. Typically, what we do in all of our contracts is we protect any pricing we provide per the market, and we require tracings to say where is that product going to. So that's why we were able to catch it pretty quickly. And so we've since worked with both distributors to ensure that we're now ensuring that product goes to the right markets for which the contracts have been written.

那我先開始，然後看看湯姆有沒有什麼要補充的。所以——順便說一句，沒錯，在我從事這個領域的職業生涯中，這並不是我第一次看到這樣的事情發生。通常情況下，我們在所有合約中都會保護我們根據市場提供的任何價格，並且要求提供追蹤信息，以說明該產品的去向。所以我們才能很快發現它。因此，我們一直與兩家經銷商合作，以確保產品能夠銷往合約中約定的正確市場。

So we're confident that it will not happen again, and we were -- we had it corrected within the quarter.

所以我們有信心它不會再次發生，而且我們也確實——我們在本季度內就糾正了這個問題。

This now concludes our question-and-answer session. I would like to turn the floor back over to Linda for closing comments.

我們的問答環節到此結束。現在我把發言權交還給琳達，請她做總結發言。

So thank you all for joining us this afternoon. We'll look forward to providing updates on our strategic progress. We've got several upcoming investor events ahead of our fourth quarter call in March. Have a great rest of your evening.

感謝各位今天下午蒞臨。我們將期待向大家報告我們的策略進展。在三月的第四季財報電話會議之前，我們將舉辦幾場投資者活動。祝您今晚餘下的時間愉快。

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. Please disconnect your lines and have a wonderful day.

女士們、先生們，感謝各位的參與。今天的電話會議到此結束。請斷開線路，祝您有美好的一天。