Kamada Ltd (KMDA) 2023 Q1 法說會逐字稿

Greetings, and welcome to the Kamada Limited First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Brian Ritchie with LifeSci Advisors. Thank you. You may begin.

您好，歡迎參加 Kamada Limited 2023 年第一季度收益電話會議。此時，所有參與者都處於只聽模式。 （操作員指示）謹此提醒，本次會議正在錄製中。現在我想將會議交給主持人 LifeSci Advisors 的 Brian Ritchie 先生。謝謝。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 is Amir London, Chief Executive Officer. Earlier today, Kamada announced its financial results for the 3 months ended March 31, 2023. If you have not received this news release, please go to the Investors page of the company's website at www.kamada.com. 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. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Wednesday, May 24, 2023.

謝謝。我是 LifeSci Advisors 的 Brian Ritchie。感謝大家參加今天的電話會議。與我一起從 Kamada 前來的是首席執行官 Amir London。今天早些時候，Kamada 公佈了截至 2023 年 3 月 31 日的三個月財務業績。如果您尚未收到本新聞稿，請訪問該公司網站 www.kamada.com 的投資者頁面。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 運營和未來業績的風險和不確定性。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 表格，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具體因素。前瞻性陳述。此外，本次電話會議的內容包含時間敏感信息，僅截至直播日期（2023 年 5 月 24 日星期三）準確。

Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that said, it is my pleasure to turn the call over to Amir London, CEO. Amir?

卡馬達沒有義務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。話雖如此，我很高興將電話轉給首席執行官阿米爾·倫敦 (Amir London)。阿米爾？

Thank you, Brian. And thanks also to our investors and analysts for interest in Kamada and for participating in today's call. We are off to an excellent start in 2023, both financially and operationally. Earlier today, we announced a $60 million strategic private placement with FIMI Opportunity Fund, the leading private equity firm in Israel and an existing significant Kamada shareholders. I will discuss this financing in further detail shortly, but we'll stay upfront that we are thrilled with this additional substantial investment from FIMI, and we view it as indicative of the confidence this high-quality investor has income as a significant growth for pension. Let us begin though with our impressive first quarter financial results. The total revenues in the first quarter of $30.7 million, which represented year-over-year growth of 9% and EBITDA of $3.8 million, an increase of 16% as compared to the first quarter 2022.

謝謝你，布萊恩。還要感謝我們的投資者和分析師對 Kamada 的興趣並參加今天的電話會議。 2023 年，我們在財務和運營方面都有一個良好的開端。今天早些時候，我們宣布與 FIMI Opportunity Fund 進行 6000 萬美元的戰略私募，FIMI Opportunity Fund 是以色列領先的私募股權公司，也是 Kamada 的現有重要股東。我將很快進一步詳細討論這筆融資，但我們會坦率地表示，我們對 FIMI 的這筆額外巨額投資感到非常興奮，我們認為這表明了這位高質量投資者對養老金收入顯著增長的信心。讓我們從令人印象深刻的第一季度財務業績開始。第一季度總收入為 3070 萬美元，同比增長 9%，EBITDA 為 380 萬美元，較 2022 年第一季度增長 16%。

We achieved the top and bottom-line growth anticipated in our business to begin the EUV. Importantly, we continue to effectively leverage multiple growth drivers, including KEDRAB sales in the U.S., the portfolio of the 4 FDA-approved Immune Globulin acquired in late '21, CYTOGAM, HEPAGAM, VARIZIG and WINRHO, which are marketed internationally and our Israeli distribution business. Looking ahead, we expect the momentum from the first quarter to extend throughout 2023, with profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full year 2023 revenue guidance of $138 million to $146 million and EBITDA of $22 million to $26 million.

我們在開始 EUV 業務時實現了預期的營收和利潤增長。重要的是，我們繼續有效地利用多種增長動力，包括 KEDRAB 在美國的銷售、21 世紀末收購的 4 個 FDA 批准的免疫球蛋白組合、CYTOGAM、HEPAGAM、VARIZIG 和 WINRHO（在國際上銷售）以及我們的以色列分銷商業。展望未來，我們預計第一季度的勢頭將延續到2023年，盈利能力將較去年進一步顯著增強。因此，我們重申 2023 年全年收入指導為 1.38 億美元至 1.46 億美元，EBITDA 為 2200 萬美元至 2600 萬美元。

The midpoint of that range will represent profitability growth of approximately 35% over 2022. Beyond 2023, we continue to anticipate annual double-digit revenue and profitability growth in the foreseeable use ahead of us with significant upside potential and limited downside risk. Our prospects were recently further significantly enhanced by the successful completion of multiple key achievements. Most importantly, we entered into a securities purchase agreement with FIMI to purchase $60 million of our ordinary shares in a private placement. Out of the terms of the purchase agreement, Kamada will issue an aggregate of approximately 12.6 million ordinary shares to FIMI at a price of $4.75 per share, which represents the average closing price of the company's shares on NASDAQ during the 20 trading days prior to the date of the purchase agreement.

該範圍的中點將代表 2022 年盈利能力增長約 35%。 2023 年之後，我們繼續預計在可預見的使用中，年度收入和盈利能力將實現兩位數增長，具有巨大的上行潛力和有限的下行風險。最近，通過成功完成多項關鍵成就，我們的前景進一步顯著增強。最重要的是，我們與 FIMI 簽訂了證券購買協議，以私募方式購買 6000 萬美元的普通股。根據收購協議的條款，Kamada 將向 FIMI 發行總計約 1260 萬股普通股，發行價格為每股 4.75 美元，該價格代表該公司股票在納斯達克交易前 20 個交易日的平均收盤價。購買協議的日期。

Upon the closing of the transaction, FIMI is expected to beneficially own approximately 38% of Canada outstanding ordinary shares and will become a controlling shareholder of the company within the meaning of the Israeli company's law. This strategic investment provide us with financial flexibility allowing us to accelerate the growth of our existing business and pursue compelling business development opportunities. We are grateful for the continued support shown by FIMI and we look forward to leveraging our significantly strengthened cash position going forward.

交易完成後，FIMI預計將實益擁有約38%的加拿大已發行普通股，並將成為以色列公司法意義上的該公司的控股股東。這項戰略投資為我們提供了財務靈活性，使我們能夠加速現有業務的增長並尋求引人注目的業務發展機會。我們感謝 FIMI 的持續支持，並期待著利用我們顯著增強的現金狀況繼續前進。

An extraordinary general meeting of the shareholders of the company to approve the private placement will be held in August 2023 following the issuance of our second quarter of '23 financial results. With respect to our existing business, we were pleased earlier this month to receive the FDA approval to manufacture CYTOGAM at our facility in Beit Kama, Israel. This have the approval, which was granted within the expected timeline represented a successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring. We have since initiated commercial manufacturing, which will positively impact our facility utilization and efficiency. CYTOGAM is the highest selling of the 4 Immune Globulin products acquired by Canada in November 21, generating approximately $23 million in sales in 2022, and it maintained gross margins of over 50%.

在我們發布 2023 年第二季度財務業績後，公司將於 2023 年 8 月召開股東特別大會，批准此次私募。關於我們現有的業務，我們很高興本月早些時候獲得 FDA 批准在我們位於以色列拜特卡馬的工廠生產 CYTOGAM。該批准在預期時間內獲得批准，代表著 CYTOGAM 從前製造商 CSL Behring 的技術轉讓過程的成功結束。此後我們開始商業化生產，這將對我們的設施利用率和效率產生積極影響。 CYTOGAM是加拿大11月21日收購的4種免疫球蛋白產品中銷量最高的，2022年銷售額約為2300萬美元，毛利率保持在50%以上。

I'd like to highlight that CYTOGAM is the third product in addition to GLASSIA and KEDRAB to be approved by the SBA for manufacturing at our Israeli facility. Also of note, SwissMedic recently granted marketing authorization for GLASSIA in Switzerland for chronic augmentation and maintenance therapy in adults with clinically evident [and Tizen] due to severe Alpha-1 deficiency. Switzerland is the first European country to approve GLASSIA for Alpha-1 deficiency, representing a significant milestone for Canada in a market which is currently estimated to be over $15 million annually.

我想強調的是，CYTOGAM 是繼 GLASSIA 和 KEDRAB 之外第三個獲得 SBA 批准在我們以色列工廠生產的產品。另外值得注意的是，SwissMedic 最近在瑞士授予了 GLASSIA 的營銷授權，用於對因嚴重 Alpha-1 缺乏而臨床明顯 [和 Tizen] 的成人進行長期增強和維持治療。瑞士是第一個批准 GLASSIA 治療 Alpha-1 缺乏症的歐洲國家，這對加拿大來說是一個重要的里程碑，該市場目前估計每年超過 1500 萬美元。

The commercial launch of the product in Switzerland is expected to occur during the second half of this year upon obtaining the acquired reimbursement coverage. To ensure wide access to eligible patients, we have partnered with the [Hydrogen] Group, a company focused on the commercialization of specialty medicines for rare diseases across Europe. Outside of the U.S., sales of GLASSIA were approximately $6 million in 2022, and we are focused on further expanding the commercialization of the product and its annual revenue in the international markets.

在獲得報銷範圍後，該產品預計將於今年下半年在瑞士上市。為了確保廣泛接觸符合條件的患者，我們與 [Hydrogen] Group 合作，該公司專注於歐洲罕見疾病專業藥物的商業化。在美國以外，2022 年 GLASSIA 的銷售額約為 600 萬美元，我們致力於進一步擴大該產品的商業化及其在國際市場的年收入。

Let's move on to KEDRAB, our Rabies Immune Globulin. In the past several months and especially since the beginning of the year, KEDRAB marketed in the U.S. and Kedrion have continued to grow substantially and to gain share in the U.S. market, which is estimated to be over $150 million annually. KEDRAB commercial team is successfully leveraging the advantages of the product as the only human Rabies Immune Globulin developed in the U.S. to be clinically studied in children. We anticipate that some of the products will continue to grow significantly over the next few years. Also to reiterate what we have said previously, I should highlight that this product generates more than 50% gross margin for Canada.

讓我們繼續討論 KEDRAB，我們的狂犬病免疫球蛋白。過去幾個月，特別是今年年初以來，在美國銷售的 KEDRAB 和 Kedrion 持續大幅增長，並擴大了美國市場份額，預計每年超過 1.5 億美元。 KEDRAB 商業團隊成功利用了該產品的優勢，該產品是美國開發的唯一一種在兒童中進行臨床研究的人類狂犬病免疫球蛋白。我們預計某些產品在未來幾年將繼續大幅增長。另外，為了重申我們之前所說的內容，我要強調的是，該產品為加拿大帶來了超過 50% 的毛利率。

Additionally, our U.S. team established during 2022 is making excellent progress in promoting our specialty IgG portfolio to physicians and other health care partitioners through our direct engagement and opportunities at medical meetings. As a reminder, our activities promoting with important therapies primarily CYTOGAM and VARIZIG represent the first time in over a decade that this high-time immune specialty products have been supported by field-based activity in the U.S. We are encouraged by the consistently positive feedback received from key opinion leaders who are seeking to publish new clinical data related to our products while conducting educational symposium that we believe will have a positive impact on the understanding of these medicines, contributing to continued growth in demand. We have started seeing the impact of activity and expect to see increased demand for this portfolio of products in the quarters ahead.

此外，我們於 2022 年成立的美國團隊通過我們在醫療會議上的直接參與和機會，在向醫生和其他醫療保健人員推廣我們的專業 IgG 產品組合方面取得了巨大進展。謹此提醒，我們以 CYTOGAM 和 VARIZIG 為主的重要療法的推廣活動代表了十多年來這種重要的免疫專業產品首次得到美國現場活動的支持。我們對收到的持續積極反饋感到鼓舞來自關鍵意見領袖的意見，他們在舉辦教育研討會的同時尋求發布與我們產品相關的新臨床數據，我們相信這將對這些藥物的理解產生積極影響，從而促進需求的持續增長。我們已經開始看到活動的影響，並預計在未來幾個季度對該產品組合的需求將會增加。

Moving on, looking further ahead of future catalysts. We are pleased by the progress made at Kamada Plasma, our U.S.-based plasma collection company. Our 2021 acquisition of the plasma collection center and in Houston, Texas represented Kamada's entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma product company. We are successfully expanding the hyper immune plasma collection capacity at our first center and are actively advancing our plan to open additional centers in the U.S. to further enhance our supply of specialty and regular normal plasma.

繼續前進，進一步展望未來的催化劑。我們對位於美國的血漿採集公司 Kamada Plasma 所取得的進展感到高興。我們於 2021 年收購了德克薩斯州休斯頓的血漿採集中心，標誌著 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种血漿產品公司的戰略目標。我們正在成功擴大我們第一個中心的超免疫血漿採集能力，並積極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種和常規正常血漿的供應。

On the development side, we are encouraged by the most recent progress achieved in our ongoing pivotal Phase III InnovAATe clinical trial for the [EML] Alpha-1 antitrypsin therapy for the treatment of Alpha-1 deficiency. The study has enrolled 60 patients to date, an independent data safety monitoring board recently recommended study continuation without modification for the fifth time since the study was initiated. During the next few weeks, we're continuing to expedite trial recruitment, we intend to meet with FDA and the European Medicine Agency to discuss study progress and potential opportunities to shorten the regulatory pathway.

在開發方面，我們正在進行的用於治療 Alpha-1 缺陷的 [EML] Alpha-1 抗胰蛋白酶療法的關鍵 III 期 InnovAATe 臨床試驗所取得的最新進展令我們感到鼓舞。迄今為止，該研究已招募了 60 名患者，獨立數據安全監測委員會最近自該研究啟動以來第五次建議不加修改地繼續研究。在接下來的幾週內，我們將繼續加快試驗招募，我們打算與 FDA 和歐洲藥品管理局會面，討論研究進展和縮短監管途徑的潛在機會。

As we have said previously, a substantial opportunity exists for Alpha-1 to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and Europe. Before I review our first quarter financial results, I'd like to share some additional exciting news. Following the $60 million investment from FIMI, Kamada's CFO, Chaime Orlev, who had previously planned to transition out of its position to pursue other opportunities has withdrawn his resignation and will remain in its position. Chaime has served our CFO since December 2017, and he will be inclement in supporting Kamada's continued growth and maximizing the strategic opportunities provided by the private placement.

正如我們之前所說，在美國和歐洲年銷售額已超過 10 億美元的市場中，Alpha-1 存在成為轉型產品的巨大機會。在回顧我們第一季度的財務業績之前，我想分享一些額外的令人興奮的消息。在 FIMI 投資 6000 萬美元之後，Kamada 的首席財務官 Chaime Orlev 此前曾計劃離職去尋求其他機會，但現在他撤回了辭呈，並將繼續留任。 Chaime 自 2017 年 12 月起擔任我們的首席財務官，他將大力支持 Kamada 的持續增長，並最大限度地利用私募提供的戰略機會。

In addition, Nir Livneh, who previously served as our General Counsel and Corporate Secretary for 2010 until 2018, has rejoined Kamada as Vice President, General Counsel and Corporate Secretary. Both Chaime and Nir significantly strengthened our executive management team, and they will play pivotal roles in our further advancements as a global leader in the specialty plasma industry.

此外，Nir Livneh 曾於 2010 年至 2018 年擔任我們的總法律顧問和公司秘書，現已重新加入 Kamada，擔任副總裁、總法律顧問和公司秘書。 Chaime 和 Nir ​​都顯著增強了我們的執行管理團隊，他們將在我們作為特種等離子體行業全球領導者的進一步發展中發揮關鍵作用。

With that, I'll now discuss our first quarter financial results. Total revenues for the first quarter were approximately $30.7 million, a 9% increase from the 21 -- 20 -- sorry, from the $28.1 million, I repeat, $28.1 million recorded in the first quarter of 2022. The year-over-year growth during the first quarter was primarily driven by strong sales of KEDRAB, the contribution of our previously acquired Immune Globulin products and the Israeli distribution sales. Total gross profit for the first quarter of 2023 was $11.8 million, representing 39% margin compared to $11.3 million or 40% margin in the first quarter of 2022.

接下來，我將討論我們第一季度的財務業績。第一季度的總收入約為 3070 萬美元，比 2022 年第一季度的 2810 萬美元增長 9%。 同比增長第一季度的主要推動力是 KEDRAB 的強勁銷售、我們之前收購的免疫球蛋白產品的貢獻以及以色列分銷銷售的貢獻。 2023 年第一季度的毛利潤總額為 1180 萬美元，利潤率為 39%，而 2022 年第一季度的毛利潤為 1130 萬美元，利潤率為 40%。

Let's now turn to the explanation of our depreciation expenses. As previously discussed, the company's accounting for depreciation expenses associated with intangible assets, which were generated through the late 2020 acquisition of our IgG products. Gross profit and gross margin, excluding such intangible asset depreciation would have been $13.2 million and 43%, respectively, in the first quarter of this year compared to $12.6 million and 45%, respectively, in the first quarter of 2022. Operating expenses, including R&D, sales and marketing, G&A and other expenses totaled $11.6 million in the first quarter of this year compared to $11.1 million in the first quarter of 2022.

現在讓我們來解釋一下折舊費用。如前所述，公司對與無形資產相關的折舊費用進行了會計處理，這些費用是通過 2020 年底收購我們的 IgG 產品而產生的。不計此類無形資產折舊，今年第一季度的毛利潤和毛利率分別為 1,320 萬美元和 43%，而 2022 年第一季度分別為 1,260 萬美元和 45%。運營費用，包括今年第一季度的研發、銷售和營銷、一般管理費用和其他費用總計 1160 萬美元，而 2022 年第一季度為 1110 萬美元。

Sales and marketing costs for the first quarter included $0.4 million of depreciation expenses of intangible assets generated through the IgG product acquisition. During the first quarter of 2023, we conducted a planned workforce downsizing at the Israeli plant, optimizing staff level to capacity needs. As a result of this downsizing, we incurred an expense of $0.6 million for access severance compensation provided to employees who were laid off. The downsizing is expected to result in a planned annualized reduction of approximately 6% in the overall Israeli labor costs.

第一季度的銷售和營銷成本包括通過收購 IgG 產品產生的無形資產折舊費用 40 萬美元。 2023 年第一季度，我們對以色列工廠進行了計劃裁員，根據產能需求優化員工水平。由於此次裁員，我們產生了 60 萬美元的費用，用於向被解僱的員工提供遣散費。此次裁員預計將使以色列整體勞動力成本按計劃每年減少約 6%。

We continue to expect our overall operational expenses, excluding R&D, sales and marketing and G&A to increase between 15% to 20% during 2023 as compared to last year as we continue to advance our commercial activities as well as our Phase III InnovAATe trial. As we did throughout 2022, we continue to account for financing expenses with respect to the revaluation of contingent consideration and the long-term assumed liability, all of which are related to the acquisition completed in 2021. For the first quarter of 2023, these finance charges totaled $1.8 million. Net loss for the first quarter of 2023 was approximately $1.8 million or $0.04 per share on a fully diluted basis, consistent with the prior year period.

我們仍然預計，隨著我們繼續推進商業活動以及第三階段 InnovAATe 試驗，2023 年我們的整體運營費用（不包括研發、銷售和營銷以及一般管理費用）將比去年增加 15% 至 20%。正如我們在 2022 年全年所做的那樣，我們繼續核算與或有對價重估和長期承擔負債有關的融資費用，所有這些都與 2021 年完成的收購有關。在 2023 年第一季度，這些財務費用費用總計180萬美元。 2023 年第一季度的淨虧損約為 180 萬美元，或完全攤薄後每股 0.04 美元，與上年同期一致。

Excluding the depreciation expenses of intangible assets and the finance expenses of the contingent consideration and other assumed long-term liabilities associated with the acquired products, the company would have recorded net income of $1.7 million or $0.04 per share in the first quarter of 2023. EBITDA was $3.8 million for the first quarter of 2023 as compared to $3.3 million in the first quarter of 2022, representing a significant 16% increase year-over-year. Excluding the $0.6 million expense of the access severance compensation paid to the employees who were laid off, EBITDA would have been $4.4 million in the first quarter of 2023, representing a significant 33% increase year-over-year. As I highlighted earlier, we are reiterating our full year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million. The midpoint of such range represents approximately 35% growth as compared to the fiscal year 2022.

不計無形資產折舊費用、或有對價的財務費用以及與所收購產品相關的其他承擔的長期負債，該公司在 2023 年第一季度將錄得淨利潤 170 萬美元，即每股 0.04 美元。 EBITDA 2023 年第一季度的營收為 380 萬美元，而 2022 年第一季度為 330 萬美元，同比大幅增長 16%。不包括向被解僱員工支付的 60 萬美元遣散費，2023 年第一季度的 EBITDA 將為 440 萬美元，同比大幅增長 33%。正如我之前強調的，我們重申 2023 年全年收入指導為 1.38 億美元至 1.46 億美元，EBITDA 指導為 2200 萬美元至 2600 萬美元。該範圍的中點代表與 2022 財年相比增長約 35%。

Finally, cash used in operating activities was $2.9 million in the first quarter of 2023 as compared to cash provided by open activities of $5.5 million in the first quarter of 2022. Our total cash position as of March 31, 2023, was $27.1 million compared to $34.3 million as of end of 2022. This figure does not include expected net proceeds from the recently announced $60 million financing, which is expected to close in the second half of this year. That concludes our prepared remarks. We will now open the call for questions. Operator?

最後，2023 年第一季度經營活動使用的現金為 290 萬美元，而 2022 年第一季度公開活動提供的現金為 550 萬美元。截至 2023 年 3 月 31 日，我們的現金頭寸總額為 2,710 萬美元，而 2022 年第一季度開放活動提供的現金為 550 萬美元。截至 2022 年底，融資金額為 3430 萬美元。這一數字不包括最近宣布的 6000 萬美元融資的預期淨收益，該融資預計將於今年下半年完成。我們準備好的發言到此結束。我們現在開始提問。操作員？

(Operator Instructions) Our first question comes from the line of David Bautz with Zacks Small-Cap Research.

（操作員說明）我們的第一個問題來自 Zacks Small-Cap Research 的 David Bautz。

First one, I'll start out with, were there any surprises, either positive or negative, that occurred during the quarter? Or do you think everything kind of played out as you thought it would?

首先，我首先要問的是，本季度是否發生了任何意外事件，無論是積極的還是消極的？或者你認為一切都按照你的想法進行？

The quarter played out according to our plan, according to our budget. We are progressing exactly as we've anticipated both, say, top line and bottom line. And based on that, we reiterated our annual guidance.

這個季度是按照我們的計劃和預算進行的。我們的進展完全符合我們的預期，比如營收和利潤。在此基礎上，我們重申了我們的年度指導。

All right. So for your guidance for the year, it looks like revenues are going to kind of ramp up as the year goes along in order to hit that number. So I'm just kind of curious where do you think that growth is going to come from?

好的。因此，就今年的指導而言，隨著時間的推移，收入似乎會有所增加，以達到這個數字。所以我有點好奇你認為增長將從哪裡來？

So the result of the quarter met the company expectations, as I said, we started the strong many aspects, we're refiling the focus for the whole year. And as you've seen in previous years, the first half of the year is usually lower than the second part of the year. A lot has to do with inventories at the distributors. So the growth will come from all aspects of the business from KEDRAB, from the new IgG portfolio from distribution business in Israel, from royalties paid by Takeda for GLASSIA sales in the U.S. For GLASSIA sales, ex U.S., all our growth catalysts, all our lines of business are operating according to our plan, according to our budget, and we will continue at that pace. And as I said, we're reiterating our guidance based on everything that we see in the market.

所以這個季度的結果達到了公司的預期，正如我所說，我們在很多方面都開始強勁，我們正在重新聚焦全年的重點。正如您在前幾年所看到的，上半年通常低於下半年。很大程度上與經銷商的庫存有關。因此，增長將來自 KEDRAB 業務的各個方面，來自以色列分銷業務的新 IgG 產品組合，來自武田為美國 GLASSIA 銷售支付的特許權使用費。對於 GLASSIA 銷售（美國除外），我們所有的增長催化劑，我們所有的業務線正在按照我們的計劃和預算運營，我們將繼續以這個速度進行。正如我所說，我們根據我們在市場上看到的一切重申我們的指導。

Okay. Now in regards to the InnovAATe trial, are you happy with the pace of enrollment that's going on there? Is there anything else that can happen to maybe kind of speed up enrollment in that trial?

好的。現在，關於 InnovAATe 試驗，您對那裡的註冊速度感到滿意嗎？還有什麼可能會加快該試驗的註冊速度嗎？

So of course, we were not happy with the pace of enrollment during the pandemic, which delayed the ability to open new sites. The sites will open in the second part of 2022. And recruitment has been since then accelerated. In order to speed up recruitment, we need to open additional sites. We are in the process of identifying the additional sites internationally and that's our plan moving forward to expedite recruitment by opening additional sites in other countries.

當然，我們對大流行期間的入學速度並不滿意，這延遲了開設新站點的能力。這些站點將於 2022 年下半年開放。此後招聘速度一直在加快。為了加快招聘速度，我們需要開設更多網站。我們正在國際上確定其他站點，這就是我們計劃通過在其他國家/地區開設更多站點來加快招聘速度。

All right. Sounds good. Congrats on the progress this quarter.

好的。聽起來不錯。祝賀本季度取得的進展。

Of course. Thank you very much.

當然。非常感謝。

(Operator Instructions) I'll turn the floor back to Mr. Ritchie for any additional questions from the web.

（操作員說明）如果有任何來自網絡的其他問題，我會將發言權轉回給 Ritchie 先生。

A couple of questions here from the web, Amir. Can you please provide a bit more color on FIMI?

阿米爾，有幾個來自網絡的問題。您能在 FIMI 上提供更多顏色嗎？

Yes, of course. So FIMI was established in 1996. It's the leading Israeli private equity team with excellent international reach, international success. It has acquired control in, I believe, around close to 100 companies over the years, have made over 60 exits. Total transaction value is over $7 billion. They are known to be a long-term investor with superb return on investments between 2015 and 2022. Over the course of those 7 years, we've deployed over $1.8 billion in acquiring equity portfolio companies. There has been a major investor in Canada since end of 2019, early 2020. And as I said, we are very happy with additional funding and private placement, and we believe that's basically a big trust in Canada. The company was interested in the investment offered by FIMI as well as our Board and the special committee was established by the Board to accelerate growth, both organically and identifying and realizing new business development opportunities. And I believe that this kind of shared interest is something that will drive Kamada and value to our shareholders significantly.

是的當然。因此，FIMI 於 1996 年成立。它是以色列領先的私募股權團隊，具有卓越的國際影響力和國際成功。我相信，多年來它已經控制了大約 100 家公司，並已退出 60 多家公司。總交易價值超過70億美元。眾所周知，他們是長期投資者，在 2015 年至 2022 年間擁有極好的投資回報。在這 7 年裡，我們已投入超過 18 億美元收購股權投資組合公司。自 2019 年底、2020 年初以來，加拿大出現了一位主要投資者。正如我所說，我們對額外資金和私募感到非常滿意，我們相信這基本上是對加拿大的巨大信任。該公司對 FIMI 以及我們的董事會提供的投資感興趣，董事會成立了特別委員會，以加速增長，既有機地發展，又發現和實現新的業務發展機會。我相信這種共同利益將極大地推動 Kamada 的發展並為我們的股東帶來價值。

Great. Also, can you expand more on the potential use of proceeds from the financing? And are there any near-term business development opportunities on the horizon?

偉大的。另外，您能否進一步介紹融資收益的潛在用途？近期是否有任何業務發展機會？

Thank you for the questions. Good questions. So as I said the company is interested in funding to accelerate growth, both organically with our existing business, but also by identifying and realizing new business diverse opportunities. We are constantly examining opportunities for collaboration in licensing, acquisition, M&A in our areas of expertise. If we were to rely only on organic profitability, it would have a significant delay, the ability to execute on such transactions. And of course, we'll delay the company ability to excel growth. So the combination of our organic growth, which you see in our guidance for the year, with this additional funding, give us basically the ability to benefit or enjoy both worlds, organic growth and external growth basically by examining opportunities for in-licensing or acquisition of additional assets.

謝謝你的提問。好問題。正如我所說，公司有興趣通過融資來加速增長，既與我們現有業務有機結合，又通過識別和實現新的業務多樣化機會。我們不斷探索我們專業領域內許可、收購、併購方面的合作機會。如果我們僅依賴有機盈利能力，那麼執行此類交易的能力將會顯著延遲。當然，我們會延遲公司實現卓越增長的能力。因此，我們的有機增長（您在今年的指導中看到）與這筆額外資金的結合，使我們基本上能夠通過審查許可或收購的機會，從有機增長和外部增長中受益或享受這兩個世界。額外資產。

Great. At this time, we've got no further questions, so I'll hand the call back over to you for any closing remarks.

偉大的。目前，我們沒有其他問題了，因此我會將電話轉回給您，以便您發表結束語。

Thank you. Thank you, Brian. So in closing, we are very pleased with our performance to begin the year. And we're excited with the potential opportunities that lie ahead following the $60 million financing by FIMI. We look forward to continuing to support initial patients with important life selling therapeutics that we develop, manufacture and commercialize. We thank all of our investors for their support, and we remain committed to create long-term shareholder value. Thank you, everyone, and we hope you all stay healthy and safe.

謝謝。謝謝你，布萊恩。最後，我們對年初的表現非常滿意。我們對 FIMI 融資 6000 萬美元後所面臨的潛在機會感到興奮。我們期待繼續為最初的患者提供我們開發、製造和商業化的重要生命療法的支持。我們感謝所有投資者的支持，我們將繼續致力於創造長期股東價值。謝謝大家，我們希望大家保持健康和安全。

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。