Kamada Ltd (KMDA) 2025 Q3 法說會逐字稿

Good morning. Welcome to Kamada Limited third-quarter 2025 earnings conference call. (Operator Instructions) Please note, this conference is being recorded.

早安.歡迎參加 Kamada Limited 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。

At this time, I'll turn the conference over to Brian Ritchie with LifeSci Advisors. Thank you, Brian. You may now begin.

現在，我將把會議交給 LifeSci Advisors 的 Brian Ritchie。謝謝你，布萊恩。現在你可以開始了。

Thank you. This is Brian Ritchie with LifeSci Advisors. Thank you all for participating in today's call. Joining me from Kamada are Amir London, Chief Executive Officer; and Chaime Orlev, Chief Financial Officer.

謝謝。我是 LifeSci Advisors 的 Brian Ritchie。感謝各位參加今天的電話會議。與我一同來自 Kamada 的有執行長 Amir London 和財務長 Chaime Orlev。

Earlier today, Kamada announced its financial results for the 3 months and 9 months ended September 30, 2025. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com.

今天早些時候，鐮田公司公佈了截至 2025 年 9 月 30 日的 3 個月和 9 個月的財務表現。如果您尚未收到此新聞稿，請造訪本公司網站 www.kamada.com 的投資者頁面。

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks, and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

在會議開始之前，我想提醒大家，管理層在本次電話會議中發表的評論將包含前瞻性陳述，這些陳述涉及風險以及有關 Kamada 營運和未來業績的不確定性。我建議您查閱公司向美國證券交易委員會提交的文件，包括但不限於本公司的 20-F 表格和 6-K 表格，其中列出了可能導致實際結果或事件與前瞻性聲明中描述的結果或事件存在重大差異的具體因素。

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Monday, November 10, 2025. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

此外，本次電話會議的內容包含有時效性的信息，這些信息僅在直播當天（2025 年 11 月 10 日，星期一）有效。Kamada 不承擔任何義務修改或更新任何聲明以反映本次電話會議日期之後發生的事件或情況。

With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir.

接下來，我很高興將電話交給執行長 Amir London。阿米爾。

Thank you, Brian. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I'm pleased to report that our results for the third quarter and first nine months of 2025 were strong and as we continue to generate significant profitable growth.

謝謝你，布萊恩。我還要感謝各位投資人和分析師對 Kamada 的關注，以及參加今天的電話會議。我很高興地報告，我們2025年第三季和前九個月的業績表現強勁，並且我們將繼續實現顯著的獲利成長。

Total revenues for the first 9 months of the year were $135.8 million, representing an 11% year-over-year increase. And adjusted EBITDA was $34.2 million, up 35% year over year and representing a 25% margin of revenues.

今年前 9 個月的總收入為 1.358 億美元，年增 11%。調整後的 EBITDA 為 3,420 萬美元，年成長 35%，佔營收的 25%。

We expect to continue generating profitable growth through the remainder of 2025. And based on our positive outlook, we are reiterating our annual revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of between $40 million and $44 million, representing double-digit growth over our 2024 results. We are excited for the growth prospects in our business over both the near and longer term, guided by our 4-pillar growth strategy, including organic commercial growth, business development and M&A transactions, our plasma collection operation and the advancement of our pivotal Phase III inhaled AAT program. Our lead product continues to be our anti-rabies immunoglobulin KEDRAB, which is being distributed in the US through our collaboration with Kedrion from which we have a firm commitment to minimum orders for 2025 through 2027 and where the supply agreement with them further extends through 2031.

我們預計在 2025 年剩餘時間內將繼續實現獲利成長。基於我們積極的展望，我們重申年度營收預期為 1.78 億美元至 1.82 億美元，調整後 EBITDA 預期為 4,000 萬美元至 4,400 萬美元，較 2024 年業績實現兩位數成長。我們對公司近期和長期的成長前景感到興奮，這得益於我們的四大支柱成長策略，包括有機商業成長、業務發展和併購交易、血漿採集業務以及關鍵的 III 期吸入 AAT 專案的推進。我們的主打產品仍然是抗狂犬病免疫球蛋白 KEDRAB，該產品透過與 Kedrion 的合作在美國分銷，我們已與 Kedrion 簽訂了 2025 年至 2027 年的最低訂單保證，並且與他們的供應協議將進一步延長至 2031 年。

In addition to a significant market share in the US, we continue to grow sales of the product in leading international markets such as Canada, Latin American countries and a few Asian markets. Revenue growth for the first 9 months of the year compared to the first 9 months of 2024 was primarily attributable to the increased sales of GLASSIA, our AAT IV product in ex-US markets, mainly Latin America and the CIS region. In addition to our sales in those countries, the product continues to generate royalty income on sales by Takeda in the US and Canadian markets.

除了在美國擁有顯著的市場份額外，我們還在加拿大、拉丁美洲國家和一些亞洲市場等領先的國際市場持續成長該產品的銷售額。今年前 9 個月的營收成長與 2024 年前 9 個月相比，主要歸功於 GLASSIA（我們的 AAT IV 產品）在美國以外市場（主要是拉丁美洲和獨聯體地區）的銷售成長。除了我們在這些國家的銷售額外，該產品還繼續為武田製藥在美國和加拿大市場的銷售帶來特許權使用費收入。

Our ability to generate significant profitable growth is indicative of the diversity of our portfolio and our successful marketing activities across different territories and medical specialties. Moving on to our anti-CMV immunoglobulin, CYTOGAM. As you may recall, earlier this year, we announced the initiation of a comprehensive post-marketing research program for CYTOGAM, which we believe will help demonstrate the advantages of the product in the prevention and management of the CMV disease. Although CMV continues to be a significant risk factor for organ rejection and mortality in transplantation, for years, no new up-to-date clinical data regarding the benefit of CYTOGAM were published. To address this, we developed this program in collaboration with leading key opinion leaders to explore advancement of novel CMV disease management.

我們能夠實現顯著的獲利成長，這表明我們產品組合的多樣性以及我們在不同地區和醫療專業領域成功的行銷活動。接下來是我們的抗CMV免疫球蛋白，CYTOGAM。您可能還記得，今年早些時候，我們宣布啟動 CYTOGAM 的全面上市後研究計劃，我們相信這將有助於證明該產品在預防和治療 CMV 疾病方面的優勢。儘管 CMV 仍然是器官移植中器官排斥和死亡的重要風險因素，但多年來，沒有關於 CYTOGAM 益處的最新臨床數據發表。為了解決這個問題，我們與主要意見領袖合作制定了該計劃，以探索新型 CMV 疾病管理的發展。

In October, we announced enrollment of the first patient in an investigator-initiated trial included in this program. The trial called Strategic Help with immunoglobulin to enhance protection against late CMV disease or SHIELD is a prospective randomized controlled multicenter investigator-initiated study in CMV high-risk kidney transplant recipients. The SHIELD study will investigate the benefits of CYTOGAM administrated at the conclusion of the antiviral prophylaxis to reduce the risk of clinically significant late CMV in kidney transplant recipients who are CMV seronegative and have a CMV seropositive donor. Those patients are at the highest risk of developing late onset CMV infection, which is associated with worst transplant recipient health and outcomes. We are very pleased to be working with notable experts in this field, and we believe that the data generated by this study and others planned for this program will support increased product utilization for CYTOGAM leading to organic growth.

10 月，我們宣布了該計畫中包含的一項研究者發起的試驗的首例患者入組。這項名為「策略性免疫球蛋白輔助治療以增強對晚期 CMV 疾病的保護」或 SHIELD 的試驗是一項前瞻性隨機對照多中心研究者發起的研究，研究對象為 CMV 高風險腎移植受者。SHIELD 研究將調查在抗病毒預防結束後給予 CYTOGAM 的益處，以降低 CMV 血清陰性且捐贈者為 CMV 血清陽性的腎移植受者發生具有臨床意義的晚期 CMV 感染的風險。這些患者發生遲發性鉅細胞病毒感染的風險最高，而遲發性鉅細胞病毒感染與移植受者健康狀況和預後最差有關。我們非常高興能與該領域的傑出專家合作，我們相信這項研究以及為該計畫計劃開展的其他研究所產生的數據將有助於提高 CYTOGAM 的產品利用率，從而實現有機增長。

Also, as part of activities to advance organic growth, following our first biosimilar product launch in Israel last year, which is expected to generate approximately $2.5 million in revenues in 2025, we will be launching 2 additional biosimilars in the coming months and have several others in the pipeline to be launched in the coming years. We believe that this portfolio will become an increasingly important portion of our distribution business with annual sales of between $15 million to $20 million within the next 5 years. Moving to business development and M&A. We continue to conduct active due diligence over several potential commercial targets. During early part of 2026, we expect to secure compelling in-licensing, collaboration and/or M&A transactions, which will enrich our portfolio of marketed products and complement our existing commercial operation.

此外，作為推動有機成長活動的一部分，繼去年我們在以色列推出首款生物相似藥產品（預計到 2025 年將產生約 250 萬美元的收入）之後，我們將在未來幾個月推出另外 2 款生物類似藥，並且還有幾款產品正在研發中，將在未來幾年內推出。我們相信，在未來 5 年內，該產品組合將成為我們分銷業務中越來越重要的組成部分，年銷售額將在 1500 萬美元至 2000 萬美元之間。轉入業務拓展及併購領域。我們正持續對幾個潛在的商業目標進行積極的盡職調查。預計在 2026 年初，我們將達成具有吸引力的引進許可、合作和/或併購交易，這將豐富我們已上市產品的組合，並補充我們現有的商業運營。

We anticipate that such transactions will generate synergies with our current commercial portfolio and support our long-term profitable growth. In addition, we are ramping up plasma collection at our Houston and San Antonio plasma centers. Both facilities support 50 donor beds with a planned peak capacity of approximately 50,000 liters per year each and are anticipated to be 2 of the largest collection centers for specialty plasma in the US A few weeks ago, we announced that the Houston facility already received FDA approval, and we expect the San Antonio site to follow in early 2026. We intend to seek subsequent inspection and approvals from the European Medicine Agency, the EMA, of both sites.

我們預計此類交易將與我們目前的商業組合產生協同效應，並支持我們的長期獲利成長。此外，我們正在休士頓和聖安東尼奧血漿中心加大血漿採集力道。這兩個設施均設有 50 張捐贈床位，計劃年處理能力高峰約為 50,000 公升，預計將成為美國最大的特種血漿採集中心之二。幾週前，我們宣布休士頓的設施已獲得 FDA 批准，我們預計聖安東尼奧的設施將於 2026 年初獲得批准。我們打算隨後向歐洲藥品管理局（EMA）申請這兩個地點的檢查和批准。

We are currently engaged in discussion with potential customers to secure long-term sales agreements for normal source plasma. As previously stated, each of those 2 centers is expected to generate annual revenues of $8 million to $10 million in sales of normal source plasma at full capacity. Turning now to our ongoing pivotal Phase III InnovAATe clinical trial for inhaled alpha-1 antitrypsin therapy. We continue to advance this program with its revised enrollment goal of approximately 180 subjects, and we are on track to complete an interim futility analysis and announce its results by the end of this quarter. With that, I'll turn the call over to Chaime for a detailed discussion of our financial results for the third quarter and 9 months of 2025.

我們目前正與潛在客戶洽談，以確保簽訂正常來源血漿的長期銷售協議。如前所述，這兩個中心預計在滿載運轉的情況下，每年透過銷售正常來源血漿可產生 800 萬至 1,000 萬美元的收入。現在讓我們來看看我們正在進行的吸入式α-1抗胰蛋白酶療法的關鍵性III期InnovAATe臨床試驗。我們繼續推進該項目，修訂後的招募目標為約 180 名受試者，我們預計在本季度末完成中期無效性分析並公佈結果。接下來，我將把電話交給 Chaime，讓他詳細討論我們 2025 年第三季和前 9 個月的財務表現。

Chaime, please go ahead.

Chaime，請繼續。

Thank you, Amir. As Amir stated at the top of the call, we reported strong results for the quarter and 9 months ended September 30, 2025. Total revenues were $47 million in the third quarter of '25, up 13% compared to $41.7 million in the third quarter of '24. Total revenues for the first 9 months of 2025 were $135.8 million, an 11% increase from the $121.9 million generated in the first 9 months of 2024. The increase in revenues was driven by the diversity of our product portfolio, primarily attributed to increased sales of GLASSIA in ex US

謝謝你，阿米爾。正如 Amir 在電話會議開始時所說，我們公佈了截至 2025 年 9 月 30 日的季度和前 9 個月的強勁業績。2025 年第三季總營收為 4,700 萬美元，比 2024 年第三季的 4,170 萬美元成長了 13%。2025 年前 9 個月的總收入為 1.358 億美元，比 2024 年前 9 個月的 1.219 億美元增加了 11%。營收成長主要得益於產品組合的多元化，這主要歸功於GLASSIA在美國以外地區的銷售成長。

markets, increased sales driven by our distribution segment and VARIZIG sales in the US market It is important to note that we continue to achieve double-digit growth even through the expected decline in GLASSIA royalty income as a result of the reduction in the royalty rate that went into effect during the third quarter. Gross profit and gross margins were $19.8 million and 42% in the third quarter of '25 compared to $17.2 million and 41% in the third quarter of '24. For the first 9 months of 2025, gross profits were $59.4 million and 44% compared to $52.9 million and 43% in the first 9 months of 2024. The increase in both matrices is in line with the continued improvement of product sales mix and the overall increase in our commercial scale.

市場方面，我們的分銷部門推動了銷售額的成長，VARIZIG 在美國市場的銷售額也有所成長。值得注意的是，儘管由於第三季生效的特許權使用費率下調，GLASSIA 特許權使用費收入預計會下降，但我們仍然實現了兩位數的成長。2025 年第三季毛利和毛利率分別為 1,980 萬美元和 42%，而 2024 年第三季分別為 1,720 萬美元和 41%。2025 年前 9 個月的毛利為 5,940 萬美元，年增 44%，而 2024 年前 9 個月的毛利為 5,290 萬美元，年增 43%。兩項指標的成長均與產品銷售組合的持續改善以及我們商業規模的整體成長一致。

Operating expenses, including R&D, sales and marketing and G&A and other expenses, totaled $11.9 million in the third quarter of 2025, similar to the level reported in the third quarter of 2024. Operating expenses totaled $36.8 million in the first 9 months of 2025 as compared to $38 million in the first 9 months of 2024. The decrease is mainly related to a reduction in R&D expenses, which was related to development project timing changes. Net income was $5.3 million or $0.09 per diluted share in the third quarter of 2025, up 37% as compared to the third quarter of 2024. Net income for the first 9 months of 2025 was $16.6 million or $0.29 per diluted share, up 56% compared to the first 9 months of 2024.

2025 年第三季的營運費用（包括研發、銷售和行銷以及一般管理費用和其他費用）總計 1,190 萬美元，與 2024 年第三季報告的水平相似。2025 年前 9 個月的營運費用總計為 3,680 萬美元，而 2024 年前 9 個月的營運費用總計為 3,800 萬美元。下降主要與研發費用減少有關，而研發費用減少又與研發項目時間安排的變化有關。2025 年第三季淨收入為 530 萬美元，即每股攤薄收益 0.09 美元，比 2024 年第三季成長 37%。2025 年前 9 個月的淨收入為 1,660 萬美元，即每股攤薄收益 0.29 美元，比 2024 年前 9 個月增長 56%。

Adjusted EBITDA was $11.7 million in the third quarter of 2025, up 34% over the third quarter of 2024. For the first 9 months of 2025, adjusted EBITDA was $34.2 million, a 35% increase compared to the first 9 months of 2024. It should also be noted that the adjusted EBITDA for the first 9 months of 2025 was equal to that reported for the full year of 2024. For the first 9 months of 2025, cash provided by operations was approximately $17.9 million that contributed to the strong cash position of $72 million at the end of the quarter. That concludes our prepared remarks.

2025 年第三季調整後 EBITDA 為 1,170 萬美元，比 2024 年第三季成長 34%。2025 年前 9 個月的調整後 EBITDA 為 3,420 萬美元，比 2024 年前 9 個月增加了 35%。還應該注意的是，2025 年前 9 個月的調整後 EBITDA 與 2024 年全年報告的 EBITDA 相同。2025 年前 9 個月，經營活動產生的現金約為 1,790 萬美元，這使得公司在季度末的現金狀況達到強勁的 7,200 萬美元。我們的發言稿到此結束。

Operator, we're ready to open the call for questions.

接線員，我們現在可以開始接受提問了。

(Operator Instructions) Annabel Samimy, Stifel.

（操作說明）Annabel Samimy，Stifel。

Great progress on operations. I want to know a little bit more about the CYTOGAM study and how this differs from the clinical data that's already been -- that you've been using for clinical education so far, what this adds to the package? And I guess maybe you can sort of talk about the population that does have this late onset CMV. Do you now have enough information to cover the totality of the transplant population with the prior, I guess, studies that were conducted.

行動進展順利。我想進一步了解 CYTOGAM 研究，以及它與您目前用於臨床教育的臨床數據有何不同，它為這些數據增添了什麼？我想或許可以談談患有這種遲發性鉅細胞病毒感染的人。我猜想，根據先前進行的研究，您現在是否掌握了足夠的資訊來涵蓋所有移植人群？

Annabel, thank you for the question. So the main difference between the current treatment population of CYTOGAM and this SHIELD study is that currently CYTOGAM is primarily used either prophylactically at the time of the transplantation as part especially for high-risk patients, which are donor positive, recipient's negative or as part of treatment, if there is actual active disease of patients a few days or weeks into the posttransplantation, while the SHIELD study is going to test using CYTOGAM as part of late CMV after patients have been treated for a few months with the antivirals. At that point, the physician starts trimming down the antiviral usage, and that's a risk for a flare of CMV disease for the patient. So this is basically kind of prophylactic usage at late stage after transplantation as part of trimming down the antiviral usage. What percentage, I don't remember the top of my head.

安娜貝爾，謝謝你的提問。因此，目前 CYTOGAM 的治療族群與這項 SHIELD 研究的主要區別在於，目前 CYTOGAM 主要用於移植時預防性用藥，尤其適用於高風險患者（捐贈者陽性，受體陰性），或用於治療移植後幾天或幾週內出現活動性疾病的患者；而 SHIELD 研究將測試在患者接受幾個月抗病毒治療後，使用 CY TOM這時，醫生開始減少抗病毒藥物的使用，這會增加患者鉅細胞病毒感染復發的風險。所以這基本上是移植後後期的一種預防性用藥，目的是減少抗病毒藥物的使用。具體百分比是多少？我一時想不起來了。

I'd like to say around 20%, but I will check this and get back to you.

我想說大概是 20% 左右，但我會核實一下再回覆你。

Okay. Great. That was helpful color. Then I guess I'm also curious about ATD, where you are with enrollment. Clearly, there's a lot -- there's an increasing number of programs right now that are under development aside from gene therapy, there's some RNA editing options as well.

好的。偉大的。那是一種很有幫助的顏色。那麼，我也對ATD的情況感到好奇，你們的招生狀況如何？顯然，除了基因療法之外，目前還有很多其他療法正在研發中，例如 RNA 編輯療法。

So how is that impacting your enrollment? And are you still -- I mean, I know you're on target for the interim study or interim analysis. How is the enrollment completion time line looking and top line data?

那麼這會對你們的招生狀況產生什麼影響呢？你們現在——我的意思是，我知道你們的中期研究或中期分析進展順利。招生完成時間表和主要數據如何？

Okay. Good. So enrollment is continuing. As you say, that's an orphan disease and because we are -- the study is with a placebo arm. So recruitment has been a challenge since the study started and continues to be a challenge.

好的。好的。所以招生工作仍在繼續。正如你所說，這是一種罕見疾病，正因為如此——這項研究才設置了安慰劑組。因此，自研究開始以來，招募參與者一直是個難題，而這個難題至今仍然存在。

We are at around 60%, 65% enrollment currently compared to the reduced sample size for the study. We do see some competition from other studies, but the sites where we are working with -- active sites are highly committed to the Inhaled study. As you said, we will have the futility analysis results before the end of the year. We expect those results, if they are positive in terms of continuing the study to give kind of strong back wind to the study and allow us to expedite recruitment. We expect to complete recruitment by early '27 which means top line results H1 '29 because it's a 2-year treatment.

目前我們的入組率約為 60% 至 65%，而研究的樣本數則減少。我們確實看到了來自其他研究的一些競爭，但我們正在合作的站點——活躍站點——都高度致力於吸入研究。正如您所說，我們將在年底前得到無效性分析結果。我們期望這些結果如果對繼續進行研究是正面的，就能為研究帶來強勁的推動力，並使我們能夠加快招募速度。我們預計將在 2027 年初完成招聘，這意味著 2029 年上半年將公佈主要業績，因為這是一個為期 2 年的治療方案。

(Operator Instructions) Jim Sidoti, Sidoti & Company.

（操作說明）吉姆·西多蒂，西多蒂公司。

Your distribution business in the last two quarters has really shot up. I think it was 80% growth in the second quarter, 60% growth this quarter. I assume that's because of the addition of some of the new products to that business. Are these stocking orders? Or are these actual usage? Are these the kind of numbers we should expect going forward?

你們的經銷業務在過去兩個季度確實實現了大幅成長。我認為第二季度增長了 80%，本季增長了 60%。我猜是因為該公司增加了一些新產品。這些是庫存訂單嗎？這些是實際使用情況嗎？這些是我們未來應該預期出現的數字嗎？

This is actual usage. We have kind of a richer portfolio. We have launched additional few products over the last 12 months into the Israeli market. So we have a very rich portfolio currently of distributed products. Biosimilars is just one of those products, as I mentioned on the call, it has a $2.5 million contribution this year, and we're going to launch 2 additional products over the next few weeks.

這是實際使用情況。我們的投資組合相對來說更豐富一些。在過去 12 個月裡，我們向以色列市場推出了一些其他產品。因此，我們目前擁有非常豐富的分散式產品組合。正如我在電話會議上提到的，生物相似藥只是其中一種產品，它今年貢獻了 250 萬美元的收入，我們將在接下來的幾週內推出另外兩種產品。

So you should expect that this level of distribution business to continue and continue growing over the next few years.

因此，預計這種分銷業務水準將在未來幾年內持續成長。

And with the plasma collection centers in Texas, I assume you're collecting some specialty plasma now. Can you just give us a sense how much you're collecting relative to what you require? Are you collecting the bulk of what you need now for your proprietary products? And when do you think that -- or if not now, when do you think you'll be collecting enough plasma in Texas to supply your proprietary products?

鑑於德州的血漿採集中心，我猜你們現在正在採集一些特殊血漿。您能否大致說明一下，您目前收集到的資金與所需資金相比如何？您現在是否已經收集了您自有產品所需的大部分原料？那麼，您認為什麼時候——或者如果不是現在，您認為什麼時候才能在德克薩斯州收集足夠的血漿來供應您的專有產品？

So good question. We are ramping up the specialty plasma collection. The bulk of the collection now in Houston and San Antonio is still normal source plasma because when you open a new site, you first need to approve your normal source plasma collection before you can move into the specialty collection. The specialty comes primarily from the Beaumont site, which was our first site, and that's a site which is dedicated only to specialty plasma. So we are not yet at the point that majority of our needs come from our own collection, but we're still working with external suppliers, partners that we've been working for many years.

問得好。我們正在加大特種血漿的採集力道。目前休士頓和聖安東尼奧的大部分血漿採集仍然是普通血漿，因為開設新站點時，必須先批准普通血漿採集，才能開始進行特殊血漿採集。這種特殊血漿主要來自博蒙特工廠，這是我們的第一個工廠，專門生產特殊血漿。所以，我們目前還沒有達到大部分需求都來自我們自己產品系列的地步，但我們仍然與外部供應商合作，這些供應商和合作夥伴我們已經合作多年。

Over time, we will gradually increase our own self-collection, which will allow us to become more and more kind of self -- kind of vertically integrated and self-sufficient in terms of specialty plasma. In any case, we don't expect to be fully independent. We'd like to have also kind of second and third suppliers for each one of the plasma types in order to have kind of a backup plan if needed as part of our risk management. So this is something which is going to grow over time and over the next few years.

隨著時間的推移，我們將逐步增加我們自己的血漿採集量，這將使我們在特種血漿方面變得越來越自給自足，越來越具有垂直整合和自給自足的能力。總之，我們並不期望完全獨立。我們希望每種血漿類型都有第二和第三供應商，以便在必要時作為風險管理的一部分，有一個備用方案。所以，隨著時間的推移，在未來幾年裡，這件事將會不斷發展壯大。

Okay. And then last question for me. I know you said you plan to release some interim data from the clinical trial for the AATD treatment sometime I would assume in December. How will you do that? Will it be a press release?

好的。最後一個問題。我知道您說過計劃在某個時候公佈 AATD 治療臨床試驗的一些中期數據，我猜應該是在 12 月。你打算怎麼做？會以新聞稿的形式發布嗎？

Will you have a conference call? How are you going to let the street know how that trial is going?

你們會召開電話會議嗎？你打算如何讓民眾了解審判的進展？

Yes. So just to maybe give a little bit more color around this futility analysis. So it will be conducted by end of the year. Results will be publicly shared through a press release. The analysis is being performed by an unblinded external DSMB using data available to date.

是的。所以，為了更詳細地解釋一下這種徒勞分析。所以這項工作將在年底前完成。結果將透過新聞稿向公眾公佈。該分析由一個非盲的外部資料安全監測委員會 (DSMB) 使用迄今為止可用的資料進行。

We're analyzing probability of success of the study, efficacy endpoints based on a predefined success threshold. This is going to be a go/no-go futility analysis and results, as I mentioned, will be published through a PR before the end of this year.

我們正在分析研究成功的機率，以及基於預先設定的成功閾值的療效終點。這將是一項可行/不可行分析，結果正如我所提到的，將在今年年底前透過 PR 發布。

At this time, I'll turn the floor to Brian Ritchie for any questions that have come in from the web.

現在，我將把發言權交給布萊恩·里奇，讓他回答大家從網路上收到的任何問題。

First question, so can you talk about the performance of CYTOGAM to date this year, Amir? And related to that, what are the significant growth drivers year-to-date in the business?

首先，Amir，可以談談CYTOGAM今年迄今的表現嗎？與此相關的是，今年迄今為止，該業務的主要成長驅動因素是什麼？

Yes. So as described in my presentation, we are generating significant profitable growth this year as a result of the diversity of the portfolio. So growth is generated through multiple products, GLASSIA sales in ex US markets, mainly Latin America and the CIS countries where we focus on AATD disease awareness and diagnosis, and we are market leaders as well as growing sales of the product in Switzerland and Israel. VARIZIG had a strong 3 quarters in the US

是的。正如我在演講中所述，由於投資組合的多樣性，我們今年實現了顯著的獲利成長。因此，成長是透過多種產品實現的，GLASSIA 在美國以外的市場（主要是拉丁美洲和獨聯體國家）的銷售，我們專注於提高人們對 AATD 疾病的認識和診斷，並且我們是市場領導者，同時該產品在瑞士和以色列的銷售額也在不斷增長。VARIZIG在美國市場經歷了強勁的三季業績。

market. Our medical and commercial teams are making significant successful efforts in increasing awareness of the importance of using VARIZIG during chickenpox outbreaks to treat immunocompromised population, which are at risk that were exposed to the chickenpox. And as I answered on previous question, the Israel distribution business is growing, and this includes our plasma-derived products, respiratory therapies and the biosimilars. And this is in addition to the KEDRAB/KamRAB, solid strong sales, HepaGam and WinRho, especially in the US market and the MENA region, GLASSIA royalties from Takeda and CYTOGAM.

市場。我們的醫療和商業團隊正在努力提高人們對在水痘爆發期間使用 VARIZIG 治療免疫功能低下人群（即接觸過水痘病毒的人群）的重要性的認識，並取得了顯著的成功。正如我在上一個問題中回答的那樣，以色列的分銷業務正在成長，這包括我們的血漿衍生產品、呼吸療法和生物相似藥。此外，還有 KEDRAB/KamRAB 的強勁銷售業績，HepaGam 和 WinRho，特別是在美國市場和中東及北非地區，以及來自武田製藥的 GLASSIA 專利使用費和 CYTOGAM。

Specifically regarding CYTOGAM, so as I answered Annabel on the first question, to significantly expand the use of the product, there's a need for up-to-date medical and clinical information. And this was not available when we began marketing the product in late 2021. So we are working thoroughly to generate and later on to publish such medical data in collaboration with leading KOLs. And to this end, we have launched the extensive clinical program, including the SHIELD study, which I described earlier. The growth during this period -- during this clinical program will be gradual.

具體來說，關於 CYTOGAM，正如我在第一個問題中回答 Annabel 時所說，為了大幅擴大該產品的使用範圍，需要最新的醫學和臨床資訊。而當我們在 2021 年底開始推廣該產品時，這項功能還沒有推出。因此，我們正在與領先的意見領袖合作，努力產生並隨後發布此類醫學數據。為此，我們啟動了廣泛的臨床項目，包括我之前描述的 SHIELD 研究。在此期間——即在此臨床項目中——成長將是漸進的。

Specifically this year, CYTOGOM sales have been below our plan, partially due to inventory management in the channels, the time it takes to add the product to hospital formularies as well as fewer transplants performed during H1 in some of the hospitals where the product is used, we are addressing -- we have addressed and we are addressing these issues and expect resumed growth during the next few months.

今年，CYTOGOM 的銷售額低於我們的計劃，部分原因是通路庫存管理不善、將產品添加到醫院處方集需要時間，以及上半年一些使用該產品的醫院進行的移植手術數量較少。我們正在解決這些問題，並預計未來幾個月將恢復成長。

Thanks, Amir. With respect to GLASSIA royalties, now that those have declined to 6%, can you elaborate on where they'll go next year?

謝謝你，阿米爾。關於 GLASSIA 的版稅，既然現在已經下降到 6%，您能否詳細說明明年的版稅會是多少？

Yes. So as I think everyone knows, starting mid-August, meaning like 1.5 months into the third quarter, we just ended, the royalties agreement with Takeda reached its second phase, which includes 6% royalties on their net market sales in the US and Canada. This agreement is going to continue until 2040, meaning that we have a very long tail of additional 15 years of royalties, and we expect the royalties to be above $10 million in 2026 and continue to grow at single-digit rate annually thereafter. Important to say that we are planning for this event.

是的。所以我想大家都知道，從 8 月中旬開始，也就是我們剛結束的第三季開始大約 1.5 個月後，與武田製藥的特許權使用費協議進入了第二階段，其中包括對其在美國和加拿大的淨市場銷售額支付 6% 的特許權使用費。該協議將持續到 2040 年，這意味著我們將有長達 15 年的特許權使用費收入，我們預計 2026 年特許權使用費將超過 1000 萬美元，此後每年將繼續以個位數的速度增長。需要說明的是，我們正在為這項活動做準備。

This is not a surprise for us. And as demonstrated in our Q3 results, and Chaime mentioned it, and our full year 2025 guidance, we have alternative revenues and profitability sources and that results from the diversity of the portfolio, and this is compensating for the reduction of the royalties moving into 2026 and beyond. Just as an example, one example, GLASSIA growth in the international markets doubled between '23 and '24 and expect it to continue growing this year and beyond. And this is just one of the products in our portfolio, which allows us to compensate on the reduction of the royalties and to continue growing the business in a very profitable way.

這對我們來說並不意外。正如我們在第三季業績中所展示的，Chaime 也提到了這一點，以及我們在 2025 年全年業績指引中所指出的，我們擁有多元化的收入和盈利來源，這得益於投資組合的多樣性，並且能夠彌補 2026 年及以後特許權使用費的減少。舉個例子，GLASSIA 在國際市場的成長在 2023 年到 2024 年間翻了一番，預計今年及以後將持續成長。而這只是我們產品組合中的一款產品，這使我們能夠彌補版稅的減少，並以非常有利可圖的方式繼續發展業務。

Thanks, Amir. Final question. Maybe you can comment on your current BD activities and seemingly lengthy time line to execute a transaction.

謝謝你，阿米爾。最後一個問題。或許您可以就您目前的業務拓展活動以及看似漫長的交易執行週期發表一些看法。

Yes, of course. So as I mentioned during the call, we continue to conduct active due diligence activities over several potential commercial targets. We expect to secure such transaction at the early stage of 2026. The timelines for execution are a little bit longer than what we expected, but this is because we are basically doing a thorough due diligence, looking for the right transaction for Kamada, which will best fit our capabilities, commercial and operational synergies and available resources. I'm confident that similar to the transaction we've done in the past, we would also be successful in selecting and integrating the right assets for Kamada in the current phase of our BD activities.

是的當然。正如我在電話會議中提到的，我們正在繼續對幾個潛在的商業目標進行積極的盡職調查活動。我們預計將在 2026 年初完成此類交易。執行時間表比我們預期的要長一些，但這主要是因為我們正在進行徹底的盡職調查，為 Kamada 尋找最合適的交易，以最大程度地發揮我們的能力、商業和營運協同效應以及可用資源。我相信，與我們過去完成的交易類似，在我們目前的業務拓展活動中，我們也能夠成功地為 Kamada 選擇和整合合適的資產。

Thanks, Amir. I'll let you give your closing remarks now.

謝謝你，阿米爾。現在請您作總結發言。

Okay. Thanks, Brian. So in closing, we continue to invest in our four-pillar growth strategy with continued progress made in organic growth of our existing commercial portfolio, the business development and M&A transaction to support and expedite our growth, expansion of our plasma collection programs and progression of our AAT therapy program. We look forward to continue to support clinicians and patients with important life-saving products that we develop, manufacture and commercialize. And we thank you all for your interest and support, and we remain committed to creating long-term shareholder value.

好的。謝謝你，布萊恩。最後，我們將繼續投資於我們的四大支柱成長策略，在現有商業組合的有機成長、業務發展和併購交易方面取得持續進展，以支持和加快我們的成長，擴大我們的血漿採集計劃，並推進我們的 AAT 療法計劃。我們期待繼續透過我們研發、生產和銷售的重要救生產品來支持臨床醫生和患者。感謝大家的關注與支持，我們將持續致力於創造長期的股東價值。

We hope you all stay safe and healthy. Thank you very much.

希望大家平安健康。非常感謝。

Ladies and gentlemen, thank you for your participation. This concludes today's teleconference. You may now 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。現在您可以斷開線路了，祝您有美好的一天。