Kamada Ltd (KMDA) 2024 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Kamada Limited first-quarter 2024 earnings conference call. (Operator Instructions) This call is being recorded on Wednesday, May 8, 2024.

早安，女士們、先生們，歡迎參加 Kamada Limited 2024 年第一季財報電話會議。（操作員說明）此通話錄音時間為 2024 年 5 月 8 日星期三。

I would now like to turn the conference over to Mr. Brian Ritchie from LifeSci Advisors. Please go ahead, sir.

我現在想將會議轉交給 LifeSci Advisors 的 Brian Ritchie 先生。請繼續，先生。

Thank you. This is Brian Ritchie with LifeSci Advisors, and 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 three months ended March 31, 2024. 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，鐮田公佈了截至 2024 年 3 月 31 日的三個月財務表現。如果您尚未收到本新聞稿，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。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。

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 8, 2024. 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訊息，僅截至直播日期（2024 年 5 月 8 日星期三）準確。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。

With that said, it is 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, Brian. My thanks also to our investors and analysts for their interest in Kamada and for participating in today's call.

謝謝你，布萊恩。我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。

We are extremely pleased with the strong financial and operational start to 2024, including nearly doubling our profitability as compared to the first quarter of last year. Importantly, based on our strong performance in the first quarter and our expectation for the continued momentum in our business throughout 2024, we are raising our full-year 2024 revenue guidance to be between $158 million to $162 million, and we are also increasing our adjusted EBITDA guidance to be between $28 million to $32 million.

我們對 2024 年強勁的財務和營運開局感到非常滿意，包括我們的獲利能力比去年第一季幾乎翻倍。重要的是，基於我們第一季的強勁表現以及我們對2024 年業務持續成長勢頭的預期，我們將2024 年全年營收指引提高至1.58 億美元至1.62 億美元之間，同時我們也提高了調整後的EBITDA 指引為 2,800 萬至 3,200 萬美元。

I will begin with a high-level review of our strong financial results for the first quarter of 2024. We generated total revenues of $37.7 million, which represented a robust year-over-year growth of 23%, and recorded adjusted EBITDA of $7.5 million, a 96% increase compared to the first quarter of 2023, representing a 20% margin of revenues. We are very pleased with this substantial increase in profitability.

我將首先對 2024 年第一季強勁的財務業績進行高層回顧。我們的總營收為 3,770 萬美元，年增 23%，調整後 EBITDA 為 750 萬美元，較 2023 年第一季成長 96%，營收利潤率為 20%。我們對獲利能力的大幅提高感到非常高興。

While we benefit from the strengths of our entire portfolio of six FDA-approved products, we continue to effectively leverage the two most important growth drivers in our business, KEDRAB and Cytogam. We are encouraged by the continued growth demonstrated by KEDRAB in the US market. And with respect to the Cytogam, we are starting to see the benefits of the direct physician engagement and promotional activities being executed by our US medical and commercial team.

雖然我們受益於我們六種 FDA 批准產品的整個產品組合的優勢，但我們繼續有效地利用我們業務中兩個最重要的成長動力：KEDRAB 和 Cytogam。我們對 KEDRAB 在美國市場的持續成長感到鼓舞。就 Cytogam 而言，我們開始看到我們的美國醫療和商業團隊執行的醫生直接參與和促銷活動的好處。

Multiple studies conducted by leading US transplantation KOLs related to the benefits of Cytogam have been accepted for presentation at transplantation-related medical meetings this year, in addition to the presentation last October at IDWeek. We expect continued steady growth in demand for this important product, which is the only one of its kind approved by the FDA and Health Canada.

除了去年 10 月在 IDWeek 上的演講外，美國領先的移植 KOL 進行的多項與 Cytogam 益處相關的研究已被接受在今年的移植相關醫學會議上進行演講。我們預計這項重要產品的需求將持續穩定成長，該產品是唯一獲得 FDA 和加拿大衛生部批准的同類產品。

Moving on, I would like to highlight our strong balance sheet. We ended the first quarter with approximately $48 million in cash, and we continue to have the financial strength to both accelerate the growth of our existing business and pursue compelling business development opportunities, a process we remain actively engaged in and which could add one or more commercial products to our existing portfolio. These opportunities are expected to support continued significant growth beyond 2024.

接下來，我想強調一下我們強勁的資產負債表。第一季結束時，我們擁有約4800 萬美元的現金，並且我們繼續擁有財務實力，可以加速現有業務的增長並尋求引人注目的業務發展機會，我們將繼續積極參與這一過程，並且可以增加一個或多個商業產品添加到我們現有的產品組合中。這些機會預計將支持 2024 年後的持續顯著成長。

I should also highlight that during the first quarter, we completed the successful launch in Israel of Bevacizumab Kamada, the biosimilar to Avastin, which is indicated for the treatment of certain types of cancer, including colon cancer and metastatic breast cancer. This represents the first biosimilar product to be launched and distributed by Kamada in Israel. We have several others in the pipeline to be launched in the coming years, and we expect biosimilars to become an increasingly important aspect of our distribution business.

我還想強調的是，第一季度，我們在以色列成功推出了貝伐珠單抗卡馬達（Bevacizumab Kamada），這是阿瓦斯汀（Avastin）的生物仿製藥，適用於治療某些類型的癌症，包括結腸癌和轉移性乳癌。這是 Kamada 在以色列推出和分銷的第一個生物相似藥產品。我們還有其他幾種藥物正在醞釀中，並將在未來幾年推出，我們預計生物相似藥將成為我們分銷業務中越來越重要的一個面向。

Looking further ahead at future catalysts, enrollment continues in the ongoing pivotal Phase 3 InnovAATe clinical trial of our inhaled alpha-1 antitrypsin therapy for the treatment of alpha-1 deficiency. The following recent receipt of positive feedback from the FDA, through which the agency expressed its willingness to potentially accept a p-value of 0.1 alpha level in evaluating InnovAATe for meeting the study efficacy primary endpoint for registration, we recently filed an IND amendment with both a revised statistical analysis plan and study protocol. We anticipate further FDA feedback in the second half of this year. If approved, these changes may allow for the acceleration of the program.

進一步展望未來的催化劑，我們的吸入 α-1 抗胰蛋白酶療法用於治療 α-1 缺乏症的關鍵 3 期 InnovAATe 臨床試驗仍在繼續進行。最近收到 FDA 的積極回饋，該機構表示願意在評估 InnovAATe 是否滿足註冊的研究功效主要終點時可能接受 0.1 alpha 水平的 p 值，我們最近提交了 IND 修正案，其中包括修訂後的統計分析計劃和研究方案。我們預計 FDA 將在今年下半年提供進一步的回饋。如果獲得批准，這些變更可能會加速該計劃的實施。

In addition, to reiterate what we said in our last call, the FDA also previously reconfirmed our design of an ongoing clinical program and endorsed the Data and Safety Monitoring Board unblinded positive safety assessment. The agency also accepted our plan to conduct an open-label extension study, which is expected to be initiated already this month.

此外，為了重申我們在上次電話會議中所說的內容，FDA 先前也再次確認了我們正在進行的臨床計劃的設計，並認可了數據和安全監測委員會的非盲積極安全評估。該機構還接受了我們進行開放標籤擴展研究的計劃，預計該研究將於本月啟動。

As a reminder, the European Medicine Agency, the EMA, previously also reconfirmed the overall design of the ongoing InnovAATe study and acknowledged the statistically and clinically meaningful improvement in lung function as measured by FEV1, demonstrated in our prior Phase 2/3 European study. As we have said previously, in parallel to the significant clinical and regulatory progress achieved, we also continue to have active discussions with multiple parties related to potential partnering of this promising late-stage product candidate.

提醒一下，歐洲藥品管理局(EMA) 先前也再次確認了正在進行的InnovAATe 研究的總體設計，並承認透過FEV1 測量的肺功能在統計學和臨床上有意義的改善，這在我們之前的2/3 期歐洲研究中得到了證明。正如我們之前所說，在取得重大臨床和監管進展的同時，我們也繼續與多方就這一有前景的後期候選產品的潛在合作進行積極討論。

We also continue to progress Kamada Plasma collection operation in the US. We continue to successfully expand the hyper-immune plasma collection capacity at our first center, and construction is nearly completed at our second plasma center located in Houston, Texas, expected to be opened during the second half of this year. We recently also signed the lease agreement for our third site located in San Antonio, Texas.

我們也繼續在美國推進 Kamada 血漿採集業務。我們繼續成功擴大第一個中心的超免疫血漿採集能力，位於德克薩斯州休斯頓的第二個血漿中心的建設已接近完成，預計將於今年下半年開業。我們最近也簽署了位於德克薩斯州聖安東尼奧的第三個基地的租賃協議。

With that, I'll now turn the call over to Chaime for a detailed discussion of our financial results for the first quarter of 2024. Chaime, please go ahead.

現在，我將把電話轉給 Chaime，詳細討論我們 2024 年第一季的財務表現。柴米，請繼續。

Thank you, Amir. As previously discussed by Amir, our business performed extremely well to begin 2024.

謝謝你，阿米爾。正如 Amir 之前所討論的，我們的業務在 2024 年伊始表現非常出色。

Total revenues for the quarter were approximately $37.7 million, a 23% increase from the $30.7 million recorded in the first quarter of 2023. The year-over-year growth was primarily driven by increased sales of both KEDRAB and Cytogam due to increased demand of the two products in the US market.

該季度的總收入約為 3,770 萬美元，比 2023 年第一季的 3,070 萬美元成長 23%。年比成長主要是由於美國市場對 KEDRAB 和 Cytogam 兩種產品的需求增加而導致這兩種產品的銷售增加。

For Cytogam, as Amir indicated, our promotional activities and the availability of fresh product batches since October of 2023 are supporting the revenue growth during the first quarter and for the remainder of the year. Nearly 70% of our revenues during the first quarter of 2024 were generated by sales in the US market.

對於 Cytogam 來說，正如 Amir 所言，我們的促銷活動和自 2023 年 10 月以來的新鮮產品批次的供應正在支持第一季和今年剩餘時間的收入成長。2024 年第一季度，我們有近 70% 的營收來自美國市場的銷售。

Total gross profit for the first quarter of 2024 was $16.8 million, representing a 44% margin, up 500 basis points when compared to the $11.8 million, or 39%, in the prior year period.

2024 年第一季的總毛利為 1,680 萬美元，利潤率為 44%，比去年同期的 1,180 萬美元（39%）增長了 500 個基點。

Operating expenses, including R&D, sales and marketing, G&A, and other expenses, totaled $12.7 million, an increase of approximately 9% over the prior year period, which is in line with our expectations. Such increase is in support of our expanded commercial activities, as well as our Phase 3 InnovAATe trial. As we did throughout 2023 and 2022, we continue to account for financing expenses with respect to re-evaluation of contingent consideration and the long-term assumed liabilities, all of which are related to the acquisition completed in 2021.

營運費用（包括研發、銷售和行銷、一般行政費用及其他費用）總計 1,270 萬美元，比上年同期成長約 9%，符合我們的預期。這種增加是為了支持我們擴大的商業活動以及我們的第三階段 InnovAATe 試驗。正如我們在 2023 年和 2022 年所做的那樣，我們繼續考慮重新評估或有對價和長期承擔負債的融資費用，所有這些都與 2021 年完成的收購有關。

Net income for the first quarter was $2.3 million or $0.04 per diluted share, as compared to a net loss of $1.8 million, or $0.04 per share, recorded in the first quarter of 2023.

第一季淨利為 230 萬美元，即每股攤薄收益 0.04 美元，而 2023 年第一季的淨虧損為 180 萬美元，即每股 0.04 美元。

Adjusted EBITDA for the first quarter of 2024 was $7.5 million, nearly double that of the first quarter of 2023.

2024 年第一季調整後 EBITDA 為 750 萬美元，幾乎是 2023 年第一季的兩倍。

As Amir highlighted earlier, we anticipate continued momentum throughout 2024 with double-digit top and bottom-line growth. As such, we're increasing our full-year 2024 revenue guidance to between $158 million and $162 million and adjusted EBITDA guidance to between $28 million and $32 million.

正如阿米爾早些時候所強調的那樣，我們預計 2024 年將繼續保持勢頭，實現兩位數的營收和利潤成長。因此，我們將 2024 年全年營收指引提高至 1.58 億美元至 1.62 億美元之間，並將 EBITDA 指引調整至 2,800 萬美元至 3,200 萬美元之間。

Finally, our financial position remains strong and provides us the strength and flexibility to accelerate the growth and profitability of our existing business, pursue compelling new business development opportunities, all of which continue to support double-digit rates beyond 2024.

最後，我們的財務狀況仍然強勁，為我們提供了實力和靈活性，以加速現有業務的成長和盈利，尋求引人注目的新業務發展機會，所有這些都將在2024 年之後繼續支持兩位數的增長率。

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) Annabel Samimy, Stifel.

（操作員說明）Annabel Samimy，Stifel。

Hi, all. Thanks for taking my question. Congratulations for a great start. I guess my first question is, I know it's a small raise, but what is the main driver of the raise? Is it KEDRAB or is it Cytogam that's benefiting from the dissemination of the data that you recently presented?

大家好。感謝您提出我的問題。恭喜您有了一個好的開始。我想我的第一個問題是，我知道這是一個小額加薪，但加薪的主要動力是什麼？受益於您最近提供的數據傳播的是 KEDRAB 還是 Cytogam？

And I also want to better understand some of the patterns of business. I know there's seasonality to KEDRAB for obvious reasons. But how should we think about patterns for other parts of the business? For example, are you meaningfully impacted by plan reset to the beginning of the year or not so much? So just a little bit of detail there.

而且我還想更能理解一些商業模式。我知道 KEDRAB 存在季節性，原因顯而易見。但我們該如何考慮業務其他部分的模式呢？例如，計劃重置到年初對您的影響是否很大？所以這裡只講一點細節。

And I want to learn a little bit more about your biosimilar program and the extent to which that is going to be a driver this year. When do you think that's really going to start taking hold? Thank you.

我想更多地了解你們的生物仿製藥計劃以及該計劃今年將在多大程度上發揮推動作用。您認為這種情況什麼時候才會真正開始流行？謝謝。

Thank you, Annabel, for your great questions. So the main driver for the increase in the forecast for the year has been primarily Cytogam for the first quarter.

謝謝安娜貝爾提出的好問題。因此，今年預測增加的主要動力主要是第一季的 Cytogam。

As mentioned, we feel very comfortable with the increase we've seen in Cytogam sales. We feel very comfortable with the results of our activity. We basically kind of relaunched the product during 2023 after over a decade that it was not actively promoted. We have new medical information being collected. We have a very strong medical and commercial team, which is increasing the physician awareness of the product and its benefits. And we see the fruits of those efforts and those activities. And this has been contributing to the growth in the first quarter and what we expect to be a continuous momentum for the rest of the year.

如前所述，我們對 Cytogam 銷售額的成長感到非常滿意。我們對活動的結果感到非常滿意。在十多年沒有積極推廣該產品後，我們基本上在 2023 年重新推出了該產品。我們正在收集新的醫療資訊。我們擁有非常強大的醫療和商業團隊，這正在提高醫生對產品及其益處的認識。我們看到了這些努力和活動的成果。這推動了第一季的成長，並預計今年剩餘時間將保持持續成長動能。

In regards to seasonality, we expect the momentum to continue. There is some seasonality of a few of the products, but because we have such a rich portfolio with a variety of products, in general, we're just focusing on continuous steady growth throughout the year, quarter by quarter, based on our performance.

就季節性而言，我們預計這一勢頭將持續下去。有些產品存在一定的季節性，但由於我們擁有如此豐富的產品組合和各種產品，因此總的來說，我們只是根據我們的業績，專注於全年、逐季度的持續穩定增長。

In regards to the biosimilars, as we said previously, we believe the total potential for the current portfolio is between $32 million to $36 million of revenues to Kamada in the Israeli distribution business. This first product is one of 10 to 11 products, and its contribution will be around 10% of this, not necessarily this year, but upon kind of maturity, I believe sometime next year or the year after.

至於生物相似藥，正如我們之前所說，我們認為當前產品組合的總潛力將為 Kamada 在以色列分銷業務中帶來 3,200 萬至 3,600 萬美元的收入。第一個產品是 10 到 11 個產品中的一個，它的貢獻將在其中的 10% 左右，不一定是今年，但隨著成熟，我相信明年或後年的某個時候。

And we expect another product to be launched toward the end of this year or early 2025. And that's going to be a similar size product. So in general, each one of those products are supposed to contribute between $2 million to $4 million. And this will be accumulated over time into a very significant business, increasing the top line and profitability of our distribution business in Israel.

我們預計另一款產品將於今年底或 2025 年初推出。這將是一個類似尺寸的產品。因此，一般來說，每種產品的貢獻應在 200 萬至 400 萬美元之間。隨著時間的推移，這將累積成一項非常重要的業務，提高我們在以色列分銷業務的收入和獲利能力。

I hope I answered all your questions.

我希望我回答了你所有的問題。

And just to get a little bit more color on the biosimilar dynamic in Israel, we know how it sort of proceeded in the US. But is there a different dynamic in Israel for how biosimilars are taken up by the market?

為了更了解以色列的生物相似藥動態，我們知道它在美國的進展。但以色列市場對生物相似藥的接受度是否有不同的動態？

No, I think it's pretty similar to what we see in the US. We have currently agreement with three different biosimilar companies. Most of the portfolio is coming from Alvotech. The Israel registration and marketing authorization is based on the product getting approved either in the US or in Europe.

不，我認為這與我們在美國看到的情況非常相似。我們目前已與三家不同的生物相似藥公司達成協議。大部分產品組合來自 Alvotech。以色列註冊和行銷授權是基於產品在美國或歐洲獲得批准。

Once the product is approved in one of those territories, we can file in Israel. It takes between one to two years to get the approval. And then if we are the first biosimilar, of course, we get the majority of the market share. If you're the second or the third, we'll get a smaller market share -- very similar to what we see in other countries.

一旦產品在這些地區之一獲得批准，我們就可以在以色列提交申請。獲得批准需要一到兩年的時間。當然，如果我們是第一個生物相似藥，我們就獲得了大部分市場份額。如果你是第二或第三，我們將獲得較小的市場份額 - 與我們在其他國家看到的非常相似。

Okay, great. And any other color you can provide us on business development and what areas you might be pursuing?

好的，太好了。您可以向我們提供有關業務發展的任何其他資訊以及您可能追求的領域嗎？

So we are evaluating multiple opportunities in our areas of focus, which are plasma derived and transplantation. We are looking for commercial stage product, which will fuel our growth. This search is ongoing. We have the funds to execute on such opportunities. And once we have something new to report, we'll gladly do so.

因此，我們正在評估我們重點領域的多個機會，即血漿衍生和移植。我們正在尋找商業階段的產品，這將推動我們的成長。這項搜索正在進行中。我們有資金來抓住這些機會。一旦我們有新的情況要報告，我們會很樂意這樣做。

Okay, great. Thank you.

好的，太好了。謝謝。

Thank you. There seems to be no further questions at this time. I would now like to turn the call over to Mr. Brian Ritchie for the questions from the web.

謝謝。目前似乎沒有其他問題了。我現在想將電話轉接給 Brian Ritchie 先生，請他回答網路問題。

Thank you. Just one additional question from the web, Amir. Perhaps you can provide some more detail on the revised statistical analysis plan and study protocol submitted recently for the inhaled AAT program.

謝謝。阿米爾，還有一個來自網路的問題。也許您可以提供有關最近提交的吸入 AAT 項目修訂後的統計分析計劃和研究方案的更多詳細資訊。

Yes, sure. So based on the very positive meeting and positive feedback we received from the FDA earlier this year, we worked over the last few months to revise the statistical plan based on a p-value of 0.1. We analyzed different scenarios. It shows that a smaller sample size will be needed for the study.

是的，當然。因此，根據今年早些時候我們從 FDA 收到的非常積極的會議和積極反饋，我們在過去幾個月根據 p 值為 0.1 修改了統計計劃。我們分析了不同的場景。它表明該研究需要較小的樣本量。

This analysis was submitted to the FDA for their advice. We also had to do some small revisions in the protocol. And all of that package was submitted a few weeks ago. And we expect feedback from the FDA during the second part of the year. It will take them, we believe, a few weeks, maybe a few months to get back to us.

該分析已提交給 FDA 徵求建議。我們還必須對協議進行一些小的修改。所有這些數據包都是在幾週前提交的。我們預計 FDA 在今年下半年會提供回饋。我們相信，他們需要幾週甚至幾個月的時間才能回覆我們。

But the study is progressing according to the plan. And we are very encouraged by the regulatory clinical progress. And as I mentioned during the call, we're also in active discussion with potential partners for the program.

但研究正在按計劃進行。我們對監管臨床進展感到非常鼓舞。正如我在電話會議中提到的，我們也在與該計劃的潛在合作夥伴進行積極討論。

Terrific. Thanks, Amir. That is it for the Q&A session. I'll ask you now to make some final remarks, if you could.

了不起。謝謝，阿米爾。這就是問答環節。如果可以的話，我現在請您做最後的發言。

Yes, of course. So in closing, we are pleased with the exceptional performance during the first quarter of 2024, which was led by our diverse portfolio and commercial operation, specifically that of KEDRAB and Cytogam. We're excited with the progress of our exciting ongoing late-stage inhaled AAT clinical program and the strength of our balance sheet, generating potential business development opportunities.

是的當然。最後，我們對 2024 年第一季的出色表現感到滿意，這得益於我們多元化的投資組合和商業運營，特別是 KEDRAB 和 Cytogam 的投資組合和商業運營。我們對正在進行的令人興奮的後期吸入 AAT 臨床計劃的進展以及我們的資產負債表的實力感到興奮，這創造了潛在的業務發展機會。

We look forward to continuing to support clinicians and patients with important life-saving products that we develop, manufacture, and commercialize. We thank all of our investors for their support, remain committed to creating long-term shareholder value. We hope you all stay healthy and safe. Thank you for joining us today.

我們期待繼續透過我們開發、製造和商業化的重要救生產品為臨床醫生和患者提供支援。我們感謝所有投資者的支持，並持續致力於創造長期股東價值。我們希望你們都保持健康和安全。感謝您今天加入我們。

Thank you, sir. Ladies and gentlemen, this includes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a lovely day.

謝謝你，先生。女士們、先生們，這包括你們今天的電話會議。我們感謝您的參與，並請您斷開線路。祝你愉快。