Kamada Ltd (KMDA) 2022 Q1 法說會逐字稿

Greetings. Welcome to the Kamada Ltd. First Quarter 2022 Earnings Conference Call. (Operator Instructions) Please note, this conference is being recorded.

問候。歡迎參加 Kamada Ltd. 2022 年第一季財報電話會議。 （操作員說明）請注意，本次會議正在錄製中。

I will now turn the conference over to your host, Bob Yedid of LifeSci Advisors. You may begin.

我現在將會議轉交給主持人、LifeSci Advisors 的 Bob Yedid。你可以開始了。

Thank you, Shamali. This is Bob Yedid of 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.

謝謝你，沙瑪利。我是 LifeSci Advisors 的 Bob Yedid。感謝大家參加今天的電話會議。與我一起從 Kamada 前來的還有執行長 Amir London； Chaime Orlev，財務長。

Earlier today, Kamada announced its financial results for the 3 months ended March 31, 2022. 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，Kamada 公佈了截至 2022 年 3 月 31 日的三個月財務業績。如果您尚未收到本新聞稿，請造訪該公司網站 www.kamada.com 的投資者頁面。

Before we begin, I'd 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.

在我們開始之前，我想提醒大家，管理層在本次電話會議上發表的評論將包含前瞻性陳述，涉及 Kamada 營運和未來業績的風險和不確定性。

I encourage you to review the company's filings with the Securities and Exchange Commission including, without limitation, the company's Form 20-F and 6-K, which identify specific risk factors which may cause actual results or events to differ materially from those described in the forward-looking statements.

我鼓勵您查看該公司向美國證券交易委員會提交的文件，包括但不限於該公司的20-F 和6-K 表，其中確定了可能導致實際結果或事件與該報告中描述的結果或事件存在重大差異的特定風險因素。前瞻性陳述。

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the live broadcast, Tuesday, May 17, 2022. 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時間敏感信息，僅截至 2022 年 5 月 17 日星期二直播時準確。Kamada 不承擔修改或更新任何聲明以反映本次電話會議之後發生的事件或情況的義務。電話會議。

If you would like to ask questions, please feel free to register for the Q&A session live at the end of the call, or feel free to e-mail me, Bob Yedid, bob@lifesciadvisors.com.

如果您想提問，請隨時註冊參加通話結束時的現場問答環節，或隨時給我發送電子郵件，Bob Yedid，bob@lifesciadvisors.com。

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

話雖如此，我很高興將電話轉給執行長阿米爾·倫敦 (Amir London)。阿米爾？

Thank you, Bob. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call.

謝謝你，鮑伯。我還要感謝我們的投資者和分析師對 Kamada 的關注並參加今天的電話會議。

Our business is off to a very strong start in 2022. During the first quarter of the year, we have effectively executed on our corporate strategy and continue advancing towards becoming a fully integrated global leader in the plasma-derived specialty market.

我們的業務在 2022 年有一個非常強勁的開局。在今年第一季度，我們有效執行了我們的企業策略，並繼續朝著成為血漿衍生專業市場全面整合的全球領導者的方向前進。

Our performance during recent months is a strong testimonial of Kamada's ability to concurrently execute on multiple fronts, developing and advancing our key growth catalysts. Those catalysts includes commercialization of our IgG portfolio in the U.S. market as well as in new territories, KEDRAB growth in the U.S., the Israeli distribution activity, our U.S. plasma collection business, the last year royalty income which started in March and the inhaled AAT clinical program, which is expanding.

我們最近幾個月的業績有力地證明了 Kamada 在多個方面同時執行、開發和推進我們的關鍵成長催化劑的能力。這些催化劑包括我們的 IgG 產品組合在美國市場和新地區的商業化、KEDRAB 在美國的成長、以色列的分銷活動、我們的美國血漿採集業務、去年 3 月開始的特許權使用費收入以及吸入 AAT 臨床計劃，該計劃正在擴大。

Moreover, during the first quarter, we generated $5.5 million of operating cash flow that supported the increase of our cash position to a total of $22 million. Importantly, the first quarter represented the first full calendar quarter commercializing the portfolio of the 4 FDA-approved immunoglobulins we acquired late last year. I'm pleased to report that these 4 products delivered solid initial sales and profitability for Kamada, meeting our plans and expectations.

此外，在第一季度，我們產生了 550 萬美元的營運現金流，支持我們的現金部位增加至 2,200 萬美元。重要的是，第一季是我們去年年底收購的 4 種 FDA 批准的免疫球蛋白組合商業化的第一個完整日曆季度。我很高興地報告，這 4 種產品為 Kamada 帶來了穩定的初始銷售和盈利能力，滿足了我們的計劃和期望。

As a reminder, the acquired product generated collective revenues exceeding $40 million in 2021 with over 50% gross margins, and we anticipate to strongly grow the new portfolio revenues year-over-year through proactive promotional activities in the U.S., where our newly established subsidiary, Kamada Inc., is responsible for the commercialization and direct sales of the products.

需要提醒的是，所收購的產品在2021 年產生的集體收入超過4000 萬美元，毛利率超過50%，我們預計透過在美國的積極促銷活動，新的產品組合收入將逐年強勁增長，我們新成立的子公司在美國Kamada Inc. 負責產品的商業化和直接銷售。

Our recently appointed Vice President of U.S. Commercial Operations, Jon Knight, have begun building out our team with multiple senior staff members, all of them experienced sales and marketing professionals with established relationship with relevant U.S. health care providers. We intend to actively promote these compelling products to hospitals and physicians throughout the U.S., mainly focusing on transplantation centers. We also intend to leverage our existing strong international distribution network to grow product revenue in new territories. I'm very happy to report today that sales of the products have already been initiated during the first quarter in few additional new countries, mainly in the Middle East.

我們最近任命的美國商業營運副總裁喬恩·奈特(Jon Knight) 已開始組建由多名高級員工組成的團隊，他們都是經驗豐富的銷售和營銷專業人士，與美國相關醫療保健提供商建立了良好的關係。我們打算積極向美國各地的醫院和醫生推廣這些引人注目的產品，主要集中在移植中心。我們還打算利用我們現有的強大的國際分銷網絡來增加新領域的產品收入。我今天很高興地向大家報告，第一季產品已在其他幾個新國家（主要是中東）開始銷售。

I should also add that we continue to expect receipt of FDA approval for the production of CYTOGAM, the largest of the 4 acquired products, at our Israeli facility during the first half of 2023 after completion of the tech transfer activities which are currently at an advanced stage.

我還應該補充一點，在完成目前處於先進階段的技術轉移活動後，我們繼續預計 2023 年上半年我們的以色列工廠將獲得 FDA 批准生產 CYTOGAM，這是 4 種收購產品中最大的一個。階段。

Now let's turn to the performance of our overall business in the first quarter of 2022. We generated total revenues of $28.1 million, representing strong 13% growth over the first quarter of 2021. We also achieved gross profit of $11.3 million and gross margins of 40% in the first quarter as compared to 36% in the prior year period. This increase in our profitability was mainly driven by the 4 new IgG portfolio products, which generated gross margins of over 50%.

現在讓我們來看看2022 年第一季我們的整體業務表現。我們的總收入為2810 萬美元，比2021 年第一季強勁增長13%。我們還實現了1130 萬美元的毛利和40%的毛利率。第一季的成長率為 36%，而去年同期為 36%。我們獲利能力的成長主要是由 4 種新的 IgG 組合產品推動的，這些產品的毛利率超過 50%。

Based on our strong start to the year, we are reiterating our full year 2022 revenue guidance of between $125 million to $135 million with expected EBITDA margins of 12% to 15%. This guidance represents a 20% to 30% increase over 2021 revenue and more than 2.5x over 2021 EBITDA. Moreover, we continue to project revenue growth at a double-digit rate in the foreseeable years ahead.

基於今年的強勁開局，我們重申 2022 年全年營收指引為 1.25 億至 1.35 億美元，預計 EBITDA 利潤率為 12% 至 15%。該指引意味著營收比 2021 年成長 20% 至 30%，EBITDA 比 2021 年成長 2.5 倍以上。此外，我們繼續預計未來幾年收入將以兩位數的速度成長。

I would now like to discuss the recently established Kamada Plasma, our U.S.-based plasma collection company. You will recall our early 2021 acquisition of a plasma collection center in Texas that specializes in the collection of hyper-immune plasma used for the manufacturing of one of our specialty products. This acquisition represented Kamada entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma company.

我現在想談談最近成立的 Kamada Plasma，這是我們位於美國的血漿採集公司。您可能還記得我們於 2021 年初收購了德克薩斯州的一家血漿收集中心，該中心專門收集用於製造我們的一種特色產品的超免疫血漿。此次收購代表 Kamada 進入美國血漿採集市場，並支持我們成為一家完全一體化的特種血漿公司的策略目標。

We remain focused on expanding the hyper-immune plasma collection capacity at this center and continue to advance our plans to open additional centers in the U.S. to further enhance our supply of specialty and regular plasma. In fact, we are already in the process of selecting the site location for a second collection center to be followed by construction and start-up activities later this year.

我們仍然專注於擴大中心的超免疫血漿採集能力，並繼續推進我們在美國開設更多中心的計劃，以進一步增強我們的特殊和常規血漿的供應。事實上，我們已經在為第二個收集中心選擇地點，並將在今年稍後進行建造和啟動活動。

We are also planning to initiate the required activities for a third center by year-end. As a reminder, the planned expansion of our plasma collection capabilities is expected to enhance our IgG competitive position in various markets, support continued revenue growth and strengthen our supply chain.

我們也計劃在年底前啟動第三個中心所需的活動。需要提醒的是，計劃擴大我們的血漿採集能力預計將增強我們在各個市場的 IgG 競爭地位，支持持續的收入成長並加強我們的供應鏈。

Moving on to KEDRAB, our anti-rabies IgG. Based on the recent moderation of the COVID pandemic in the U.S., we are encouraged that the product in market sales by Kedrion during the first quarter, which has grown significantly in comparison to the pre-COVID pandemic sales level, and we believe the trend will continue. We expect KEDRAB to be an increasingly important growth driver for us over the next few years as it continues to gain market share in the $150 million U.S. market.

接下來是 KEDRAB，我們的抗狂犬病 IgG。鑑於美國新冠肺炎疫情最近的緩和，我們感到鼓舞的是，Kedrion 第一季的產品市場銷售量與新冠疫情大流行前的銷售水平相比顯著增長，我們相信這一趨勢將繼續。我們預計 KEDRAB 將在未來幾年成為我們日益重要的成長動力，因為它在 1.5 億美元的美國市場中持續獲得市場份額。

You will recall that the FDA approved a label expansion for the product late last year, which differentiated KEDRAB as the first and only human rabies immune globulin available in the U.S. to be clinically studied in children and confirming the safety and effectiveness of its use in the pediatric population. Moreover, we are also expanding sale of the product in additional important international markets, such as in Canada, Australia and Latin America.

您可能還記得，FDA 在去年年底批准了該產品的標籤擴展，這使得KEDRAB 成為美國第一個也是唯一一個在兒童中進行臨床研究的人狂犬病免疫球蛋白，並確認了其在兒童中使用的安全性和有效性。兒科人群。此外，我們也擴大了該產品在其他重要國際市場的銷售，例如加拿大、澳洲和拉丁美洲。

And for GLASSIA, in March, Takeda initiated sales of the product from its own production, generating royalty income to Kamada. Royalty for March were $1.4 million, meeting our expected monthly rate.

對於 GLASSIA，武田於 3 月開始銷售自己生產的產品，為 Kamada 帶來特許權使用費收入。 3 月份的版稅為 140 萬美元，符合我們預期的月度費率。

Turning to our InnovAATe clinical program. The moderation of the COVID pandemic allows us to expand our ongoing pivotal Phase III InnovAATe clinical trial that evaluated safety and efficacy of our innovative Inhaled AAT product for the treatment of AAT deficiency to new European sites. Most recently, patient screening and recruitment began at 3 new sites in 3 European countries. In the coming weeks, 3 additional sites are expected to be initiated in 3 other European countries.

轉向我們的 InnovAATe 臨床計劃。新冠肺炎疫情的緩和使我們能夠將正在進行的關鍵 III 期 InnovAATe 臨床試驗擴展到歐洲新地點，該試驗評估了我們創新的吸入 AAT 產品用於治療 AAT 缺乏症的安全性和有效性。最近，在 3 個歐洲國家的 3 個新地點開始進行病患篩檢和招募。未來幾週，預計將在另外 3 個歐洲國家開設另外 3 個站點。

Moreover, Independent Data Safety Monitoring Board, the DSMB, recently recommended that the trial continue without modification. To date, no patients have discontinued treatment prematurely and no drug-related serious adverse events have been reported. Additionally, to date, 9 patients have already completed the full 2-year treatment period. Importantly, this is a unified study, and the trial's data are expected to qualify for regulatory submissions with both the FDA and the EMA.

此外，獨立資料安全監測委員會（DSMB）最近建議繼續進行試驗，無需修改。迄今為止，沒有患者提前停止治療，也沒有報告與藥物相關的嚴重不良事件。此外，迄今為止，已有 9 名患者完成了完整的 2 年治療期。重要的是，這是一項統一研究，該試驗的數據預計將有資格向 FDA 和 EMA 提交監管申請。

A substantial opportunity exists for Inhaled AAT to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and Europe and growing steadily, and we're excited to further advance this stride.

在美國和歐洲年銷售額已超過 10 億美元且穩定成長的市場中，吸入 AAT 存在成為變革性產品的巨大機會，我們很高興能夠進一步推進這一進步。

Moving to other commercial activities. In our Israeli distribution segment, we plan to launch a portfolio of 11 biosimilar products between this year, 2022 and 2028. The products are expected to be launched upon receipt of the Israeli regulatory approval. Collectively, these products have an annual anticipated peak sales achievable within several years of launch of more than $40 million. This anticipated revenues are in addition to our current distribution segment sales. We look forward to the launch of the first of this biosimilar product later this year.

轉向其他商業活動。在我們的以色列分銷部門，我們計劃在今年、2022 年至 2028 年期間推出 11 種生物相似藥產品組合。這些產品預計將在獲得以色列監管部門批准後推出。總的來說，這些產品在推出後的幾年內預計年銷售額高峰將超過 4,000 萬美元。這項預期收入不包括我們目前分銷部門的銷售額。我們期待今年稍後推出首款生物相似藥產品。

In closing, we continue to execute on our corporate strategy on all fronts, and we believe that we have the appropriate catalyst to drive double-digit growth in the years ahead. We're excited about our future prospects. Kamada is uniquely positioned for growth as a global leader in the specialty plasma industry with multiple value-creating upcoming catalysts.

最後，我們繼續在各個方面執行我們的企業策略，我們相信我們有適當的催化劑來推動未來幾年的兩位數成長。我們對未來的前景感到興奮。 Kamada 身為特種等離子體產業的全球領導者，擁有獨特的發展定位，擁有多種即將推出的創造價值催化劑。

With that, I'll now turn the call over to Chaime for his review of the first quarter 2022 financial results. Chaime, please?

現在，我將把電話轉給 Chaime，請他檢視 2022 年第一季的財務表現。柴米，請嗎？

Thank you, Amir, and good day, everyone. Our revenues grew by 13% in the first quarter of 2022 and totaled $28.1 million. These revenue levels are in line with our expectations and represent a strong start of the year. This growth was led by strong initial sales of our newly acquired IgG product. This is the first full quarter of sales of this portfolio, and the sales and profitability levels generated by these products are in line with our expectations and plans.

謝謝你，阿米爾，大家好。 2022 年第一季度，我們的營收成長了 13%，總計 2,810 萬美元。這些收入水準符合我們的預期，代表了今年的強勁開局。這一成長得益於我們新收購的 IgG 產品的強勁初始銷售。這是該產品組合的第一個完整季度銷售，這些產品產生的銷售和盈利水平符合我們的預期和計劃。

As previously mentioned by Amir, we recognized $1.4 million of royalty income during March on account of GLASSIA sales by Takeda. During the first 2 months of the year, Takeda sold remaining less year inventory supplied by Kamada and initiated sales from its own production during March, entitling us to royalty income. The royalty income for March 2022 is in line with our expected monthly rate and annual projections.

正如 Amir 之前提到的，我們在 3 月確認了武田 GLASSIA 銷售的 140 萬美元特許權使用費收入。今年前 2 個月，武田出售了 Kamada 供應的剩餘年度庫存，並在 3 月開始銷售自己的產品，使我們有權獲得特許權使用費收入。 2022 年 3 月的特許權使用費收入符合我們預期的每月費率和年度預測。

As a reminder, we will receive royalty payments from Takeda at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040. We continue to expect to receive royalty payments from Takeda in the range of $10 million to $20 million per year, enhancing our profitability and cash position.

謹此提醒，截至2025 年8 月，我們將以淨銷售額12% 的比例從武田收到特許權使用費，此後直至2040 年，我們將按照6% 的比例收到武田的特許權使用費。我們預計將繼續從武田收到1000 萬美元的特許權使用費。每年 2000 萬美元，從而提高我們的盈利能力和現金狀況。

Total gross profit for the first quarter of 2022 was $11.3 million, up 27% from the $8.2 million in the first quarter of 2021. Gross margin for the quarter were 40%, an increase from the 36% during the period -- during the prior year period. The increase in profitability was primarily driven by the 4 new FDA-approved commercial products which generated gross margins of over 50%.

2022 年第一季的總毛利為 1,130 萬美元，比 2021 年第一季的 820 萬美元增長 27%。該季度的毛利率為 40%，較上一季的 36% 有所增長年。獲利能力的成長主要是由 FDA 批准的 4 種新商業產品推動的，這些產品的毛利率超過 50%。

Cost of goods sold in our Proprietary segment totaled $12.5 million in the first quarter of 2022 and included $1.3 million of depreciation expenses associated with intangible assets generated through the recent acquisition of these products. Gross margins excluding such intangible assets depreciation would have been 45%.

2022 年第一季度，我們自營部門銷售的商品成本總計 1,250 萬美元，其中包括與最近收購這些產品所產生的無形資產相關的 130 萬美元折舊費用。扣除此類無形資產折舊後的毛利率將為 45%。

Research and development investments during the first quarter of 2022 were $4.4 million. The increase as compared to the first quarter of 2021 is primarily driven by the expansion of our pivotal Phase III InnovAATe trial for Inhaled AAT through the opening of new clinical sites and the manufacturing of clinical supply for the study. Our projections for the overall trial costs did not change.

2022 年第一季的研發投資為 440 萬美元。與 2021 年第一季相比，這一增長主要是由於我們透過開設新的臨床基地和生產用於該研究的臨床供應來擴大吸入 AAT 的關鍵 III 期 InnovAATe 試驗。我們對總體試驗成本的預測並沒有改變。

Selling and marketing expenses for the first quarter of 2022 were $3.3 million, an increase from $1.1 million during the prior period. This increase is attributable to the establishment of our U.S. commercial operation to support the distribution and sale of the recently acquired portfolio of 4 FDA-approved commercial products. In addition, these costs include pre-commercial activities associated with new product launches in the Israeli distribution segment, including 1 of the 11 biosimilar products portfolio which is planned to be launched this year.

2022 年第一季的銷售和行銷費用為 330 萬美元，較上一季的 110 萬美元增加。這一增長歸因於我們在美國商業運營的建立，以支持最近收購的 4 種經 FDA 批准的商業產品組合的分銷和銷售。此外，這些成本還包括與以色列分銷領域新產品發布相關的預商業活動，其中包括計劃今年推出的 11 種生物相似藥產品組合中的一種。

Sales and marketing costs for the quarter included $400,000 of depreciation expenses associated with the intangible assets generated through the recent acquisition of the new products.

本季的銷售和行銷成本包括與最近收購新產品所產生的無形資產相關的 40 萬美元折舊費用。

Our financial expenses for the quarter included a $2 million charge associated with the revaluation of contingent consideration and the other long-term liabilities assumed as part of the acquisition of the 4 FDA-approved products. As detailed in our 2021 annual financial statements included in the recently filed annual report on Form 20-F. These liabilities include deferred consideration payments due to the sellers, subject to meeting certain milestones and royalty obligation to third parties on account of the CYTOGAM product.

我們本季的財務費用包括與或有對價重估相關的 200 萬美元費用以及作為收購 4 個 FDA 批准產品的一部分而承擔的其他長期負債。正如最近提交的 20-F 表格年度報告中所包含的 2021 年年度財務報表中的詳細資訊。這些負債包括應付給賣方的遞延對價付款（須滿足某些里程碑）以及因 CYTOGAM 產品而向第三方支付的特許權使用費。

For the first quarter, we posted a net loss of $1.8 million or $0.04 per share on a fully diluted basis. However, our adjusted EBITDA, which excludes financial expenses, depreciation, amortization and stock-based compensation for the first quarter of 2022, was $3.3 million compared to $3.7 million in the first 3 months of 2021.

第一季度，我們公佈淨虧損 180 萬美元，即完全攤薄後每股虧損 0.04 美元。然而，2022 年第一季調整後的 EBITDA（不包括財務費用、折舊、攤提和股票薪酬）為 330 萬美元，而 2021 年前 3 個月為 370 萬美元。

During the first quarter of 2022, we generated $5.5 million of operating cash flow that supported the increase of our cash position to a total of $22 million. Kamada's working capital as of March 31, 2022, remains strong and totaled $52 million.

2022 年第一季度，我們產生了 550 萬美元的營運現金流，支持我們的現金部位增加至 2,200 萬美元。截至 2022 年 3 月 31 日，Kamada 的營運資金依然強勁，總計 5,200 萬美元。

As for our full year guidance, we continue to expect to generate total revenue for fiscal year 2022 in the range of $125 million to $135 million and anticipate generating EBITDA at a range of 12% to 15% of total revenue.

至於我們的全年指引，我們仍然預計 2022 財年的總收入將在 1.25 億至 1.35 億美元之間，並預計 EBITDA 將佔總收入的 12% 至 15%。

While the ongoing labor strike impacting our production facility in Israel is expected to negatively affect our second quarter financial results, which we do not expect to be as strong as the first quarter, based on the diversification of our commercial operation, which includes multiple revenue-generating sources, including the recently acquired portfolio of 4 FDA-approved commercial products which are manufactured by an external contract manufacturer; the Israeli distribution business, which operates independent of the production facility; the royalty income on GLASSIA sales by Takeda; as well as current sufficient inventory level of finished products, our positive outlook for the fiscal year remains unchanged.

雖然持續的罷工影響了我們在以色列的生產設施，預計將對我們第二季度的財務業績產生負面影響，但基於我們商業運營的多元化（其中包括多種收入），我們預計第二季度的財務業績不會像第一季度那樣強勁——發電來源，包括最近收購的 4 種 FDA 批准的商業產品組合，這些產品由外部合約製造商生產；以色列分銷業務，獨立於生產設施運作；武田 (Takeda) 銷售 GLASSIA 的特許權使用費收入；以及目前充足的成品庫存水平，我們對本財年的樂觀前景保持不變。

Finally, I want to make investors aware that we plan to hold a virtual Investor and Analyst Day on Tuesday, June 7, at approximately 12 p.m. Eastern Time to highlight the dramatic transformation of our business over the past several months. Details will be -- details of the Investors Day will be announced shortly.

最後，我想讓投資者知道，我們計劃在 6 月 7 日星期二中午 12 點左右舉行虛擬投資者和分析師日活動。東部時間強調過去幾個月我們業務的巨大轉變。投資者日的詳細資訊將很快公佈。

That concludes our prepared remarks. We will now open the call for questions. Operator?

我們準備好的演講到此結束。我們現在開始提問。操作員？

(Operator Instructions)

（操作員說明）

Shamali, this is Bob Yedid from LifeSci. I've gotten a few questions already e-mailed into me, so I'll start with those.

Shamali，我是 LifeSci 的 Bob Yedid。我已經透過電子郵件收到了一些問題，所以我將從這些問題開始。

The first one is asking about the sales trends of the rabies vaccine. And given the improved per rates of travel in U.S. and other countries, for Amir and Chaime, are you starting to see a recovery in the sales of KEDRAB and KAMRAB compared to last year?

第一個是詢問狂犬病疫苗的銷售趨勢。鑑於美國和其他國家的旅行費用有所提高，對於 Amir 和 Chaime 來說，您是否開始看到 KEDRAB 和 KAMRAB 的銷售額與去年相比有所復甦？

Thank you, Bob, and thank you for the people asking the questions. Yes, absolutely. So during the first quarter, we've seen that Kedrion in-market sales of the product in the U.S. have grown significantly compared to the first quarter of 2021.

謝謝你，鮑勃，也謝謝你問問題的人。是的，一點沒錯。因此，在第一季度，我們看到 Kedrion 該產品在美國的市場銷售與 2021 年第一季相比顯著成長。

And basically, if I compare it to pre-pandemic levels, we see a significant increase. We believe that we have not yet completed our penetration and winning market share of the product. As a reminder, we got FDA approval in late 2017, we launched the product in the middle of 2018. So we had -- basically only 2019 was kind of the first full year of selling the product in the U.S. market, and then the pandemic started right after that.

基本上，如果我將其與大流行前的水平進行比較，我們會看到顯著增加。我們認為我們尚未完成產品的滲透並贏得市場份額。提醒一下，我們在 2017 年底獲得了 FDA 的批准，我們在 2018 年年中推出了該產品。所以我們基本上只有 2019 年才是該產品在美國市場銷售的第一個完整年份，然後是大流行之後就開始了。

So 2020 and 2021 were impacted by the pandemic. But starting 2022, the product is continuing to gain a significant market share to grow its market share. And we believe there is still a lot of room for growth for the product in the U.S. market, which is over $150 million. And we will continue to grow the business in the U.S., and we are also leveraging the growth in international markets. We are one of the few only suppliers of the anti-rabies immunoglobulin product globally. We are an approved supplier of the WHO. We're supplying the Latin American tenders. We have an approval in Canada and Australia. And we are supporting those local authorities with this important, life-saving product.

所以2020年和2021年都受到了疫情的影響。但從 2022 年開始，該產品將繼續獲得顯著的市場份額，從而擴大其市場份額。我們相信該產品在美國市場仍有很大的成長空間，市場規模超過1.5億美元。我們將繼續發展美國業務，同時我們也將利用國際市場的成長。我們是全球少數的抗狂犬病免疫球蛋白產品供應商之一。我們是世界衛生組織批准的供應商。我們正在向拉丁美洲招標。我們在加拿大和澳洲獲得了批准。我們正在透過這種重要的救生產品為當地政府提供支援。

Great. Very helpful. The other question I've gotten e-mailed in to me is about your announcement today that you've expanded the number of clinical trial sites for your Inhaled AAT Phase III trial. The question is one of why now in terms of making that expansion from basically 1 site and adding up to 6 more sites this year?

偉大的。很有幫助。我透過電子郵件收到的另一個問題是關於你們今天宣布擴大了吸入 AAT III 期試驗的臨床試驗地點的數量。問題是，為什麼現在要從 1 個站點擴展，今年又增加了 6 個站點？

Yes. So we obviously leveraging the opportunity now with the moderation of the COVID pandemic to expand the study. The study was initiated just a few weeks before the pandemic started. So we had the first patient in into the site [in light] into the Netherlands in November or December of 2019.

是的。因此，我們顯然要利用現在新冠疫情緩和的機會來擴大研究範圍。這項研究是在疫情開始前幾週開始的。因此，我們在 2019 年 11 月或 12 月讓第一位患者進入了荷蘭的 [in light] 站點。

This site continued to recruit patients throughout the pandemic, but it was hard and in some cases, even impossible to open new sites when everyone was focused only on COVID. In few countries, we couldn't initiate a new study, which was not a COVID-related study.

該網站在整個大流行期間繼續招募患者，但當每個人都只關注新冠病毒時，開設新網站很困難，在某些情況下甚至不可能。在少數國家，我們無法啟動一項新的研究，該研究不是與新冠病毒相關的研究。

You need to remember, these are patient suffering from a severe lung disease, so for them to actually go into the hospital to initiate such a treatment as part of the study was very challenging during the pandemic.

你需要記住，這些都是患有嚴重肺部疾病的患者，因此在大流行期間，作為研究的一部分，讓他們真正進入醫院開始這種治療是非常具有挑戰性的。

Now with the improvement across Europe, we have the opportunity to leverage the [work that] has been done in preparing for that timing, and we are expanding the study. We're very encouraged with what we've seen so far. We had no dropouts in the study on patients who started study in (inaudible) continued 9 of the patients already completed the 2-year study. The data that we presented to the DSMB was well received, no modifications that are needed to the studies. So we are encouraged by what we've seen so far.

現在，隨著整個歐洲的情況有所改善，我們有機會利用為此時機所做的準備工作，並且我們正在擴大研究範圍。我們對迄今為止所看到的情況感到非常鼓舞。在對開始研究（聽不清楚）的患者進行的研究中，我們沒有中途退出的患者，其中 9 名患者已經完成了為期 2 年的研究。我們向 DSMB 提交的數據受到好評，研究無需修改。因此，我們對迄今為止所看到的情況感到鼓舞。

And as a business opportunity, we remain highly confident in the significant opportunity ahead of us, over $1 billion market of Alpha-1 treatment, given currently by infusion and I think everyone understands the significant superiority in terms of quality of life for the patients to use an inhaled product versus an IV product.

作為一個商業機會，我們對擺在我們面前的重大機會仍然充滿信心，目前透過輸注提供的 Alpha-1 治療市場價值超過 10 億美元，我認為每個人都明白在患者生活品質方面的顯著優勢使用吸入產品與靜脈注射產品。

Great. Okay. That's helpful. And then the last question I have is, one, with regards to your sales and marketing of your new portfolio of IgG products. Is that sales marketing principally focused on transplantation centers here in the U.S.?

偉大的。好的。這很有幫助。我的最後一個問題是，第一個問題，關於你們新的 IgG 產品組合的銷售和行銷。該銷售行銷主要集中在美國的移植中心嗎？

So 2 of the products focus on transportation centers. These are the 2 lead products, which is CYTOGAM and HEPAGAM, very big for immunocompromised patients, not only transplanted patients but also pregnant women and small infants. So it's a little bit more diverse than just transplantation centers. And WINRHO is focused on patient suffering from a rare blood disorder called ITP.

因此，其中 2 個產品專注於交通中心。這是兩種主導產品，即 CYTOGAM 和 HEPAGAM，對於免疫功能低下的患者非常重要，不僅適用於移植患者，也適用於孕婦和小嬰兒。所以它比移植中心更加多樣化。 WINRHO 專注於患有一種名為 ITP 的罕見血液疾病的患者。

So main focus is consultation centers, but we're also selling to other medical institutions in the U.S. Outside of the U.S., similar of course focus. And we believe there is a great opportunity in the U.S. through promotional activities, those products will not proactively promoted in the last few years.

所以主要重點是諮詢中心，但我們也向美國以外的美國其他醫療機構銷售，當然重點也是類似的。我們相信在美國透過促銷活動有很大的機會，那些過去幾年不會主動促銷的產品。

So we have here an opportunity to make a big difference in growing this business and then leveraging our over 30 countries distribution network to sell the product is definitely a very big plus, and we already seeing the results of this, as I mentioned during the call, primarily in the Middle East where we have seen new countries that we have initiated sales of the product.

因此，我們有機會在發展這項業務方面發揮巨大作用，然後利用我們30 多個國家的分銷網絡來銷售產品，這絕對是一個很大的優勢，正如我在電話會議中提到的，我們已經看到了這樣做的結果，主要是在中東，我們已經看到我們已經開始銷售該產品的新國家。

Great. One other follow-up question to that is, you've talked about transferring manufacturing of these products potentially. But definitely the first one, CYTOGAM, to your facility. That is dependent, I assume, in -- for next year on the receipt of the regulatory approval in Israel. Is that correct?

偉大的。另一個後續問題是，您已經談到可能轉移這些產品的製造。但絕對是您工廠的第一個，CYTOGAM。我認為，這取決於明年是否獲得以色列監管部門的批准。那是對的嗎？

Correct. So the tech transfer of CYTOGAM from its current manufacturer to our facility in Israel is well underway. And we expect to bid file with our Beit Kama facility a manufacturer later this year and to get an approval in 2023. And in regards to the other 3 products, this is something we plan to do in the future.

正確的。因此，CYTOGAM 從目前製造商到我們以色列工廠的技術轉移正在順利進行中。我們預計在今年稍後向我們的 Beit Kama 工廠的一家製造商提交投標文件，並在 2023 年獲得批准。對於其他 3 種產品，這是我們計劃在未來做的事情。

Great. Okay, good. That's the call -- that's the question that I have. Thank you, Amir.

偉大的。好的。這就是電話——這就是我的問題。謝謝你，阿米爾。

And it looks like we have -- if there are no more questions, it looks like we have reached the end of the question-and-answer session.

看起來我們已經——如果沒有更多問題了，那麼我們的問答環節似乎已經結束了。

I now turn the call back over to Amir London for closing remarks.

現在，我將電話轉回阿米爾·倫敦，讓其致閉幕詞。

Thank you. Thank you very much. In closing, on behalf of the entire Kamada team, we look forward to continuing to provide clinicians and patients with an expanding portfolio of important life-saving products that we develop, manufacture and commercialize.

謝謝。非常感謝。最後，我們代表整個 Kamada 團隊，期待繼續為臨床醫生和患者提供我們開發、製造和商業化的不斷擴大的重要救生產品組合。

We thank all of our investors for their support and remain firmly committed to creating long-term sustainable shareholder value, leveraging our multiple catalyst of growth. We hope you all stay healthy and safe. Thank you very much.

我們感謝所有投資者的支持，並繼續堅定致力於利用我們的多重成長催化劑創造長期可持續的股東價值。我們希望你們都保持健康和安全。非常感謝。

And this concludes today's conference, and you may disconnect lines at this time. Thank you for your participation.

今天的會議到此結束，大家可以掛斷電話了。感謝您的參與。