Collplant Biotechnologies Ltd (CLGN) 2023 Q1 法說會逐字稿

Welcome to the CollPlant Biotechnologies investor conference call to discuss financial results for the first quarter of 2023 and corporate updates.

歡迎參加 CollPlant Biotechnologies 投資者電話會議，討論 2023 年第一季度的財務業績和公司最新動態。

I'd now like to turn the call over to your host, Dory Kurowski of LifeSci Advisors. Please go ahead.

現在我想將電話轉給主持人、LifeSci Advisors 的 Dory Kurowski。請繼續。

Good morning. I would like to welcome everyone to CollPlant Biotechnologies financial results conference call for the first quarter ending March 31, 2023, and corporate business update. With us on the call today from CollPlant are Yehiel Tal, Chief Executive Officer, who will provide an overview of the company's programs and forthcoming updates; and Eran Rotem, Deputy CEO and Chief Financial Officer, who will provide a summary of CollPlant's financial results for the first quarter ending March 31, 2023.

早上好。我謹歡迎大家參加 CollPlant Biotechnologies 截至 2023 年 3 月 31 日的第一季度財務業績電話會議以及公司業務更新。今天與我們一起參加 CollPlant 電話會議的是首席執行官 Yehiel Tal，他將概述公司的計劃和即將發布的更新；副首席執行官兼首席財務官 Eran Rotem 將提供 CollPlant 截至 2023 年 3 月 31 日第一季度的財務業績摘要。

Before we get started, I would like to remind everyone that statements made on this conference call may include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risk, uncertainties, and other factors, including those set forth in the risk factors section of CollPlant's filings with the Securities and Exchange Commission.

在我們開始之前，我想提醒大家，本次電話會議上的陳述可能包含前瞻性陳述。由於各種風險、不確定性和其他因素，包括 CollPlant 向美國證券交易委員會提交的文件的風險因素部分中列出的因素，實際事件或結果可能與任何前瞻性陳述中明示或暗示的事件或結果存在重大差異。

These filings can be found at www.sec.gov or on CollPlant's website at www.collplant.com. In addition, any forward-looking statements made on this call represent CollPlant's views only as of today, May 24, 2023, and should not be relied upon as representing the company's views as of any subsequent date. And CollPlant management specifically disclaims any obligation to update or revise any of these forward-looking statements.

這些文件可在 www.sec.gov 或 CollPlant 網站 www.collplant.com 上找到。此外，本次電話會議中所做的任何前瞻性陳述僅代表 CollPlant 截至今天（2023 年 5 月 24 日）的觀點，不應被視為代表該公司在任何後續日期的觀點。 CollPlant 管理層明確表示不承擔更新或修改任何這些前瞻性陳述的義務。

With that, let me turn the call over to Yehiel Tal, Chief Executive Officer of CollPlant Biotechnologies. Please go ahead, sir.

接下來，讓我將電話轉給 CollPlant Biotechnologies 首席執行官 Yehiel Tal。請繼續，先生。

Good morning, everyone. We are very pleased to have you join us today on CollPlant investor conference call to discuss our first-quarter 2023 financial results and corporate developments.

大家，早安。我們很高興您今天參加 CollPlant 投資者電話會議，討論我們 2023 年第一季度的財務業績和企業發展。

CollPlant is developing collagen technology and regenerative medicine products to improve and prolong life. We are committed to becoming the leaders in regenerative medicine and supporting a more sustainable ecosystem that benefits all stakeholders, including patients, our shareholders, our employees, as well as providing innovation to the life science industry.

CollPlant 正在開髮膠原蛋白技術和再生醫學產品，以改善和延長壽命。我們致力於成為再生醫學領域的領導者，支持一個更可持續的生態系統，使所有利益相關者受益，包括患者、我們的股東、我們的員工，並為生命科學行業提供創新。

At the heart of our business is our novel, proprietary recombinant human collagen technology. Collagen is the building block for all the human and mammalian tissues and serves as the primary scaffolding molecule in the body's connective tissues and organs. It is our goal to become the global leader in regenerative medicine by applying our non-animal-derived recombinant human collagen, or rhCollagen, to novel medical and aesthetics products.

我們業務的核心是我們新穎的、專有的重組人類膠原蛋白技術。膠原蛋白是所有人類和哺乳動物組織的組成部分，並且是人體結締組織和器官中的主要支架分子。我們的目標是通過將我們的非動物源性重組人類膠原蛋白（或 rhCollagen）應用於新型醫療和美容產品，成為再生醫學領域的全球領導者。

The hallmark of our technology, of course, is both its regenerative properties as well as that it is xenotissue free. We are applying our technology to dermal filler product candidates with a long-term collaboration with our global pharmaceutical partner, AbbVie. The dermal filler candidates have the ability to shift the filler market since they would provide regenerative properties in addition to tissue filler.

當然，我們技術的特點是它的再生特性以及它不含異種組織。我們與全球製藥合作夥伴艾伯維 (AbbVie) 長期合作，將我們的技術應用於真皮填充劑產品候選。真皮填充劑候選者有能力改變填充劑市場，因為除了組織填充劑之外，它們還提供再生特性。

This program is our top focus, and it continues to move forward according to plan. CollPlant has the potential to receive additional milestones and option payments from AbbVie related to this program as well as royalties on the dermal filler sales once this product candidate obtains approval. AbbVie continues to advance the filler program, and as stated previously, CollPlant expects that the first milestone could be achieved in 2023.

該計劃是我們的首要關注點，並且繼續按計劃推進。一旦該候選產品獲得批准，CollPlant 有可能從艾伯維獲得與該計劃相關的額外里程碑和期權付款，以及真皮填充劑銷售的特許權使用費。艾伯維 (AbbVie) 繼續推進填充劑計劃，正如之前所述，CollPlant 預計第一個里程碑可以在 2023 年實現。

Additionally, we continue to advance the development of state-of-the-art photocurable dermal and soft tissue filler. Our goal is to create an innovative filler product with three capabilities: lifting capacity, regeneration of new tissue, and controlling capabilities. As we are making these improvements to the filler product that exist today, we refer to this as a third-generation filler.

此外，我們繼續推進最先進的光固化真皮和軟組織填充劑的開發。我們的目標是創造一種具有三種功能的創新填充產品：提升能力、新組織再生和控制能力。當我們對現有的填料產品進行這些改進時，我們將其稱為第三代填料。

We believe that this filler has the potential to be highly competitive by providing both refined and natural-looking aesthetic results as well as uniquely regenerative long-term benefits. Furthermore, this technology could also be augmented to include facial and body contouring applications. CollPlant has granted AbbVie the right of first negotiation to obtain a worldwide exclusive license to this product candidate.

我們相信，這種填充劑具有高度競爭力的潛力，可提供精緻、自然的美學效果以及獨特的再生長期效益。此外，該技術還可以擴展到包括面部和身體輪廓應用。 CollPlant 已授予艾伯維 (AbbVie) 優先談判權，以獲得該候選產品的全球獨家許可。

Now let's turn toward the regenerative breast implant program. At the beginning of this year, we announced positive results from the preclinical study evaluating our regenerative implants in a large animal model. We are very encouraged by these results, which demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants with no adverse events reported.

現在讓我們轉向再生乳房植入計劃。今年年初，我們宣布了在大型動物模型中評估我們的再生植入物的臨床前研究的積極結果。我們對這些結果感到非常鼓舞，這些結果表明三個月後組織再生已進入漸進階段，植入物內成熟結締組織和新生血管網絡的形成凸顯了這一點，並且沒有報告不良事件。

This study forms the basis for our subsequent trial in the second large animal model, evaluating larger implants that we plan to initiate in the second half of this year. We are currently preparing the infrastructure to support this trial. No regenerative breast implant currently exists in the market, and these implants would be the first of their kind also having beneficial regenerative properties.

這項研究為我們隨後在第二個大型動物模型中進行的試驗奠定了基礎，評估了我們計劃在今年下半年啟動的更大的植入物。我們目前正在準備基礎設施來支持這項試驗。目前市場上還沒有可再生的乳房植入物，這些植入物將是同類中第一個也具有有益的再生特性的植入物。

Importantly, just recently in April, we announced a joint development and commercialization agreement with Stratasys, a world leader in additive manufacturing and a leader in 3D printing technology, after pioneering this technology decades ago. With Stratasys, we are collaborating on the development of a solution to biofabricate human tissues and organs.

重要的是，就在 4 月份，我們宣布與 Stratasys 達成聯合開發和商業化協議。Stratasys 是增材製造領域的全球領導者和 3D 打印技術的領導者，在幾十年前開創了這項技術。我們正在與 Stratasys 合作開發生物製造人體組織和器官的解決方案。

This collaboration combines the Stratasys DLP 3D printer that is utilizing a unique programmable photopolymerization, P3, technology together with CollPlant's state-of-the-art rhCollagen-based bioinks and 3D bioprinting capabilities. The first of our collaborative projects will focus on the development of an industrial-scale solution for CollPlant's regenerative breast implants program.

此次合作將採用獨特的可編程光聚合 P3 技術的 Stratasys DLP 3D 打印機與 CollPlant 最先進的基於 rhCollagen 的生物墨水和 3D 生物打印功能相結合。我們的第一個合作項目將側重於為 CollPlant 的再生乳房植入物項目開發工業規模的解決方案。

An effective solution for scale-up of these implants will be important to support clinical trials and commercialization. Here, you can see an example of a breast implant that was printed with Stratasys DLT 3D printer utilizing its P3 technology in combination with CollPlant's rhCollagen-based inks. Under the agreement, both companies have also agreed to cross-promote each other's bioprinted products.

擴大這些植入物規模的有效解決方案對於支持臨床試驗和商業化非常重要。在這裡，您可以看到一個乳房植入物的示例，該示例是使用 Stratasys DLT 3D 打印機打印的，該打印機利用其 P3 技術並結合 CollPlant 的 rhCollagen 墨水。根據協議，兩家公司還同意交叉推廣對方的生物打印產品。

We do have strategic collaborations for bioprinting with multiple parties. And as we have said in the past, our strategy is to utilize different printing technologies to serve different indications being sold -- for example, a product that would need to have use of multiple materials or for the printing of constructs with very small features, such as gut-on-a-chip or lung-on-a-chip tissue models.

我們確實與多方在生物打印方面有戰略合作。正如我們過去所說，我們的策略是利用不同的印刷技術來服務不同的銷售適應症 - 例如，需要使用多種材料或用於印刷具有非常小的特徵的結構的產品，例如腸道芯片或肺芯片組織模型。

The bioprinting aspect of our business has applicability in multiple areas. CollPlant implants are designed to regenerate breast tissue without eliciting immune response and therefore have the potential to become a revolutionary alternative to both aesthetic and reconstructive procedures, including post-mastectomy for cancer patients.

我們業務的生物打印方面適用於多個領域。 CollPlant 植入物旨在再生乳房組織，而不引起免疫反應，因此有可能成為美容和重建手術（包括癌症患者乳房切除術後）的革命性替代方案。

According to the US Food and Drug Administration, approximately 350,000 Americans have reported adverse events involving breast implants between 2009 and 2019. Reports range from autoimmune symptoms to breast implant-associated anaplastic large-cell lymphoma, or BIA-ALCL.

根據美國食品和藥物管理局的數據，2009 年至 2019 年間，大約有 35 萬美國人報告了涉及乳房植入物的不良事件。報告範圍從自身免疫症狀到與乳房植入物相關的間變性大細胞淋巴瘤 (BIA-ALCL)。

The additional safety and efficacy data that we will generate from this study would be used for the optimization of the regenerative implant and are important in support of future regulatory submissions and clinical studies. We look forward to reporting these results from the study next year.

我們將從這項研究中產生的額外安全性和有效性數據將用於再生植入物的優化，並且對於支持未來的監管提交和臨床研究非常重要。我們期待明年報告這些研究結果。

Shifting to our gut-on-a-chip program, this is an area where we have the opportunity to disrupt the options that have traditionally existed in life sciences. Here, we are developing a diagnostic tool for use in personalized medicine. And we expect that this approach could be ground-breaking improvement over the existing use of animal models for drug development.

轉向我們的芯片腸道項目，在這個領域，我們有機會顛覆生命科學中傳統存在的選擇。在這裡，我們正在開發一種用於個性化醫療的診斷工具。我們預計，這種方法可能會比現有的藥物開發動物模型的使用帶來突破性的改進。

In November last year, we signed a collaboration agreement with Tel Aviv University and Sheba Medical Center for our gut-on-a-chip program. I should add that we are fortunate that the university and the medical centers are close to us, only 10 miles away. So we get to collaborate with our partners face to face quite frequently, enabling strong relationships.

去年 11 月，我們與特拉維夫大學和示巴醫學中心就我們的芯片腸道項目簽署了合作協議。我應該補充一點，我們很幸運，大學和醫療中心離我們很近，僅 10 英里遠。因此，我們可以經常與合作夥伴進行面對面的合作，從而建立牢固的關係。

Our agreement with both institutions is to co-develop a bioprinted human intestine model for drug discovery and personalized treatment of ulcerative colitis. The 3D bioprinted model is designed to emulate the human intestine tissue in order to allow medical professionals to identify drug targets and personalized therapeutic responses that can lead to improved patient outcomes. Should the gut-on-a-chip receive approval, CollPlant has exclusive rights to commercialize the product.

我們與兩家機構的協議是共同開發生物打印的人體腸道模型，用於潰瘍性結腸炎的藥物發現和個性化治療。 3D 生物打印模型旨在模擬人體腸道組織，以便醫療專業人員能夠識別藥物靶點和個性化治療反應，從而改善患者的治療效果。如果芯片腸道獲得批准，CollPlant 擁有將該產品商業化的獨家權利。

Now, let me turn to our commercial portfolio bioinks. This platform was established in 2021 with the launch of Collink.3D 50. Following this, we launched Collink.3D 90, which offers increased mechanical properties and Collink.3D 50L, our first bioink available in powder form to provide enhanced operational flexibility. The entire platform allows our biopharma and academia customers to streamline their process of new product development by utilizing an animal-free alternative that delivers improved biofunctionality, safety, and reproducibility.

現在，讓我談談我們的商業生物墨水組合。該平台是在 2021 年推出 Collink.3D 50 時建立的。隨後，我們推出了 Collink.3D 90，它提供了更高的機械性能，以及 Collink.3D 50L，這是我們首款粉末形式的生物墨水，可提供增強的操作靈活性。整個平台使我們的生物製藥和學術界客戶能夠利用無動物替代品來簡化新產品開發流程，從而提高生物功能、安全性和可重複性。

CollPlant remains engaged in partnering discussions with several additional industry leaders interested in CollPlant's technology and expertise in 3D bioprinting to develop therapeutics and medical applications. We have also developed a proprietary aseptic process to mass-produce sterile rhCollagen.

CollPlant 仍在與其他幾家對 CollPlant 在 3D 生物打印方面的技術和專業知識感興趣的行業領導者進行合作討論，以開發治療和醫療應用。我們還開發了一種專有的無菌工藝來批量生產無菌 rhCollagen。

The sterile collagen that we are now producing would be utilized in our pipeline product as well as by our partners. Furthermore, it can serve as an ideal substrate for stem cells, induced pluripotent stem cells, and all kinds of primary human cells since our collagen will not elicit immune response and will accelerate cell proliferation.

我們現在生產的無菌膠原蛋白將用於我們的管道產品以及我們的合作夥伴。此外，它可以作為乾細胞、誘導多能幹細胞和各種原代人類細胞的理想基質，因為我們的膠原蛋白不會引起免疫反應並會加速細胞增殖。

Finally, this collagen will also address production processes, where collagen as a major constituent should be sterile. Now, I'll turn the call over to our Deputy CEO and Chief Financial Officer, Eran Rotem, to provide a recap of the financial results. Eran?

最後，這種膠原蛋白還將解決生產過程中的問題，其中膠原蛋白作為主要成分應該是無菌的。現在，我將把電話轉給我們的副首席執行官兼首席財務官 Eran Rotem，以概述財務業績。埃蘭？

Thank you, Yehiel. Good morning, everyone. I will now review our financial results for the three-month period ending March 31, 2023.

謝謝你，葉希爾。大家，早安。我現在將回顧我們截至 2023 年 3 月 31 日的三個月期間的財務業績。

This quarter, we saw a significant increase in revenues versus last year. For the first quarter ended March 31, 2023, GAAP revenues increased by $367,000 to $433,000, compared to $66,000 in the first quarter of 2022. Revenues from this quarter included income from sales of CollPlant bioink and rhCollagen. And the increase of more than 600% resulted mainly from an increase in sales of our rhCollagen to CollPlant's business partner.

本季度，我們的收入與去年相比顯著增加。截至 2023 年 3 月 31 日的第一季度，GAAP 收入增加了 367,000 美元，達到 433,000 美元，而 2022 年第一季度為 66,000 美元。本季度的收入包括 CollPlant bioink 和 rhCollagen 的銷售收入。超過600%的增長主要是由於我們對CollPlant業務合作夥伴的rhCollagen銷量增加。

As we said previously, according to the agreement with AbbVie, CollPlant has the potential to receive additional milestone payments based on product development milestones reached and hope and expect that the first of these milestones could be achieved in 2023.

正如我們之前所說，根據與艾伯維的協議，CollPlant 有可能根據所達到的產品開發里程碑獲得額外的里程碑付款，並希望並預計第一個里程碑可以在 2023 年實現。

GAAP cost of revenues for Q1 2023 was $325,000 compared to $31,000 in the first quarter of 2022. Cost of revenue includes mainly the cost of the company's rhCollagen-based order and royalties to the Israeli Innovation Authority for the company's sales.

2023 年第一季度的 GAAP 收入成本為 325,000 美元，而 2022 年第一季度為 31,000 美元。收入成本主要包括公司基於 rhCollagen 的訂單成本以及公司銷售向以色列創新局支付的特許權使用費。

GAAP gross profit for Q1 2023 was $108,000, an increase of $73,000 compared to gross profit of $35,000 in Q1 2022.

2023 年第一季度的 GAAP 毛利潤為 108,000 美元，比 2022 年第一季度的毛利潤 35,000 美元增加了 73,000 美元。

The company kept approximately the same GAAP operating expenses level as of last year during this quarter. Operating expenses in the first quarter of 2023 for $3.5 million (sic - see press release, "$3.6 million") compared to $3.8 million for the first quarter of 2022. On a non-GAAP basis, the operating expenses for the first quarter of 2023 were $3.1 million, a 9% reduction compared to $3.4 million for the first quarter of 2022. Non-GAAP measures exclude certain non-cash expenses.

本季度該公司的 GAAP 運營費用水平與去年大致相同。 2023 年第一季度的運營費用為 350 萬美元（原文如此 - 參見新聞稿，“360 萬美元”），而 2022 年第一季度的運營費用為 380 萬美元。按照非公認會計準則計算，2023 年第一季度的運營費用為 310 萬美元，比 2022 年第一季度的 340 萬美元減少 9%。非 GAAP 指標不包括某些非現金費用。

GAAP financial expenses, net, for the first quarter of 2023 totaled $196,000 compared to $92,000 in the first quarter of 2022. The increase in financial expenses, net, is mainly attributed to an increase in exchange rate expenses from cash and cash equivalents and a decrease in income interest received from the company's short-term cash deposits, compared to the first quarter of 2022.

2023 年第一季度 GAAP 財務費用淨額總計 196,000 美元，而 2022 年第一季度為 92,000 美元。財務費用淨額增加主要歸因於現金和現金等價物的匯率費用增加以及現金和現金等價物的匯率費用減少與 2022 年第一季度相比，從公司短期現金存款中獲得的收入利息。

GAAP net loss for the first quarter of 2023 was $3.7 million, or $0.33 basic loss per share, compared to a net loss of $3.9 million, or $0.36 basic loss per share, for the first quarter of 2022. Non-GAAP net loss for the first quarter of 2023 was $3.3 million, or $0.29 basic loss per share, compared to $3.5 million loss, or $0.32 basic loss per share for the first quarter of 2022.

2023 年第一季度的 GAAP 淨虧損為 370 萬美元，即每股基本虧損 0.33 美元，而 2022 年第一季度的淨虧損為 390 萬美元，即每股基本虧損 0.36 美元。 2023 年第一季度的虧損為 330 萬美元，即每股基本虧損 0.29 美元，而 2022 年第一季度的虧損為 350 萬美元，即每股基本虧損 0.32 美元。

We have maintained a strong cash position and have carefully contained CollPlant's, operating expenses during Q1. Cash, cash equivalents, and short-term deposits as of March 31, 2023, were $26.5 million.

我們保持了強勁的現金狀況，並在第一季度謹慎控制了 CollPlant 的運營支出。截至 2023 年 3 月 31 日，現金、現金等價物和短期存款為 2,650 萬美元。

Cash used in operation activities during the first quarter of 2023 was $3.4 million compared to $3.2 million during the first quarter of 2022. Cash provided by financing activities during the first quarter of 2023 was $803,000 compared to $1.4 million (sic - see press release, "$1.5 million") provided by financing activities during the first quarter of 2022. The decrease is mainly attributed to more proceeds from the exercise of warrants into shares [physical] last year during the same period.

2023 年第一季度運營活動使用的現金為 340 萬美元，而 2022 年第一季度為 320 萬美元。2023 年第一季度融資活動提供的現金為 803,000 美元，而 2023 年第一季度融資活動提供的現金為 140 萬美元（原文如此 - 請參閱新聞稿，“ 150 萬美元”）由 2022 年第一季度的融資活動提供。減少的主要原因是去年同期將認股權證轉換成股票[實物]的收益增加。

This now concludes the financial summary. Operator, I believe that we can now open the call for questions.

財務摘要到此結束。接線員，我相信我們現在可以開始提問了。

Thank you. At this time, we'll be conducting a question-and-answer session. (Operator Instructions)

謝謝。此時，我們將進行問答環節。 （操作員說明）

Ben Haynor, Alliance Global Partners.

Ben Haynor，聯盟全球合作夥伴。

Good day, gentlemen. Thanks for taking the questions. First of all for me, I just wanted to touch on the Stratasys agreement. I'm not entirely sure on how -- or whether the Stratasys printed implants are going to be the ones used in the second half -- or second large animal study that's second half of this year. Can you provide some clarification on that?

美好的一天，先生們。感謝您提出問題。首先對我來說，我只想談談 Stratasys 協議。我不完全確定 Stratasys 打印植入物是否會在下半年或今年下半年的第二次大型動物研究中使用。你能否對此作出一些澄清？

Yeah. Thank you, Ben, for the question. So let me elaborate on the Stratasys collaboration further. So with Stratasys, we are collaborating a development of a solution to biofabricate human tissues and organs. And this collaboration will be based on the Stratasys DLP 3D bioprinter that is utilizing unique, programmable photopolymerization, P3, technology and together with the company's bioink.

是的。謝謝你，本，提出這個問題。讓我進一步詳細闡述 Stratasys 的合作。因此，我們正在與 Stratasys 合作開發生物製造人體組織和器官的解決方案。此次合作將基於 Stratasys DLP 3D 生物打印機，該打印機利用獨特的可編程光聚合 P3 技術以及該公司的生物墨水。

The first of our collaborative project will focus on the development of an industrial-scale solution for CollPlant regenerative breast implant program. And an effective solution for scale-up of these implants will be very important to support the clinical trials and the commercialization.

我們的第一個合作項目將專注於為 CollPlant 再生乳房植入項目開發工業規模的解決方案。擴大這些植入物規模的有效解決方案對於支持臨床試驗和商業化非常重要。

We are now already in a stage where we are able to print the [inference] of different sizes, including clinical-size implants, with the Stratasys printer. And we are still optimizing the process. But the plan is to leverage this printer in the large implant studies that we will do in the second half of this year and basically print the implants in the study with this printer.

我們現在已經處於能夠使用 Stratasys 打印機打印不同尺寸的 [推斷] 的階段，包括臨床尺寸的植入物。我們仍在優化流程。但計劃是在我們將在今年下半年進行的大型植入物研究中利用這台打印機，並基本上用這台打印機打印研究中的植入物。

Okay, great. So the optimization will be complete before that occurs. And then remind me, could the -- the second large animal study, could that be used for the registration study to submit to the FDA?

好的，太好了。因此優化將在此之前完成。然後提醒我，第二個大型動物研究可以用於向 FDA 提交的註冊研究嗎？

That's a good question. Actually, of the sequence is the following. We are going to have two studies this year. Both will be used for, first of all, optimization of the formulation. This is one thing. The second one -- the second thing is for the optimization of the structure of the implant and the biodegradation kinetics.

這是個好問題。實際上，順序如下。今年我們將進行兩項研究。首先，兩者都將用於優化配方。這是一回事。第二件事——第二件事是優化植入物的結構和生物降解動力學。

So these studies that we will conduct this year, which will not be long-term studies, were served for this purpose. And with this result, at the beginning of next year, we plan to go ahead and launch a pivotal study, which will be, according to the plan, the ones that we will use in the submission of the package to the regulatory authorities.

所以我們今年要做的這些研究，不是長期的研究，就是為了這個目的。有了這個結果，我們計劃在明年初繼續啟動一項關鍵研究，根據計劃，我們將在向監管機構提交一攬子計劃時使用該研究。

Okay, great. And then just -- if you could tell me how meaningful the cross-promotion portion of the agreement with Stratasys is -- I mean, it seems to me that having a turnkey offering from Stratasys to bring to their customers would be fairly important. I'm just curious about how you see that playing out.

好的，太好了。然後，如果您能告訴我與 Stratasys 協議中的交叉推廣部分有多麼有意義，我的意思是，在我看來，從 Stratasys 向客戶提供交鑰匙產品將相當重要。我只是好奇你如何看待這種情況。

Right. Yeah, okay. So the cross-promotion is working in different ways. One way is basically that we will -- for example, if we enter a collaboration with a third party which will require us to develop a product, we will definitely prefer to do this development work and later on, the commercialization with the Stratasys printer. This would be the first choice for us, and vice versa.

正確的。好的。因此，交叉推廣正在以不同的方式發揮作用。一種方法基本上是我們會——例如，如果我們與第三方合作，需要我們開發一種產品，我們肯定會更願意進行這項開發工作，然後再使用 Stratasys 打印機進行商業化。這將是我們的第一選擇，反之亦然。

If Stratasys will go to sell their printers to users in the market, either academia or commercial companies, then they will promote our biological inks. So this is the basic nature of the collaboration. And there might be also another situation where we will jointly co-develop a product for a third-party collaborator.

如果 Stratasys 將他們的打印機出售給市場上的用戶，無論是學術界還是商業公司，那麼他們就會推廣我們的生物墨水。所以這是合作的基本性質。還可能有另一種情況，我們將共同為第三方合作者開發產品。

Okay, great. That's helpful. And then when should we expect to hear more about the third-generation photocurable soft tissue filler? My recollection was that you had submitted some data to AbbVie. Just curious on that.

好的，太好了。這很有幫助。那麼我們什麼時候應該聽到更多關於第三代光固化軟組織填充劑的信息呢？我記得你向艾伯維提交了一些數據。只是對此感到好奇。

Yeah. So first of all, regarding AbbVie, basically, the dermal filler program with AbbVie is progressing according to the plan. And as said earlier, we expect the milestone achievement for the first product that we are working together, milestone payment this year in 2023.

是的。首先，對於艾伯維來說，基本上，與艾伯維的真皮填充劑項目正在按計劃進行。正如之前所說，我們預計我們合作的第一個產品將在 2023 年實現里程碑式的付款。

The photocurable filler is another product which is currently under development. We call it a third-generation because there is a sequence of products in the market. The current gold standard is the hyaluronic acid product. The second generation is the regenerative implant, which is a dermal filler implant which is combining collagen and HA.

光固化填料是目前正在開發的另一種產品。我們稱之為第三代，因為市場上有一系列產品。目前的黃金標準是透明質酸產品。第二代是再生植入物，它是結合膠原蛋白和透明質酸的真皮填充劑植入物。

And then the third generation is one which is the photocurable. That's why it's called the third generation. And as said earlier, this is an option product. And should AbbVie decide to trigger this option. then of course, they can do that.

第三代是光固化的。這就是為什麼它被稱為第三代。正如之前所說，這是一種期權產品。艾伯維是否應該決定觸發此選項。那麼他們當然可以這麼做。

Okay, got it. And then lastly for me, I think -- well, I guess I don't recall you mentioning body contouring applications for the photocurable product. Could you talk a little bit more about those and maybe the obvious applications that you see there?

好，知道了。最後對我來說，我想——嗯，我想我不記得你提到過光固化產品的身體輪廓應用。您能否多談談這些以及您在那裡看到的明顯應用程序？

Sure, sure. So this product can be -- it's basically a technology platform that can be expanded to different areas in contouring. First of all, facial contouring and then later on, body contouring. There are different uses for it.

一定一定。所以這個產品基本上是一個技術平台，可以擴展到輪廓的不同領域。首先是面部輪廓，然後是身體輪廓。它有不同的用途。

The nice thing about the product is that you can control the stiffness of the implant by the illumination process. We also developed a unique light source that is basically able to penetrate through the tissue, through the soft tissue, and reach the implant, and basically cross-linking -- do the final cross-linking process. So we can achieve control stiffness of the implant. And this enables us to expand the use through a variety of contouring indications, which are either body or facial contouring.

該產品的優點在於您可以通過照明過程控制植入物的剛度。我們還開發了一種獨特的光源，基本上能夠穿透組織，穿過軟組織，到達植入物，並基本上進行交聯——進行最後的交聯過程。這樣我們就可以實現種植體剛度的控制。這使我們能夠通過各種輪廓適應症（身體或面部輪廓）來擴展用途。

Okay. Thank you. So I guess what would -- outside of facial, what would be an example application? I mean, is it -- if I don't like the crease in my armpit, do I get that filled? Or what are the more non-facial applications?

好的。謝謝。所以我想除了面部護理之外，還有什麼示例應用程序？我的意思是，如果我不喜歡腋下的摺痕，我可以把它填滿嗎？或者還有哪些更多的非面部應用？

First of all, it's facial shaping. For example, somebody has a recess in the nose, for example, so you can basically fill in this recess and regenerate the tissue in this place, why there is the recess. But this is just one example.

首先，就是面部整形。比如說，有人的鼻子裡有一個凹陷，那麼你基本上可以填充這個凹陷，然後再生這個地方的組織，為什麼會有這個凹陷。但這只是一個例子。

The second one, you know, on the cheeks, so to change the shape. And the nice thing is that the physician can, with the fingers, sculpt the issue and basically give you the shape which is desired, he'll then photocure it so it will lock on the same shape afterwards.

第二個，你知道，在臉頰上，所以要改變形狀。好的一點是，醫生可以用手指雕刻問題，基本上給你所需的形狀，然後他會對它進行光固化，這樣之後它就會鎖定相同的形狀。

Okay, got it. Well, thanks for taking the questions, gentlemen. This is definitely helpful.

好，知道了。好的，謝謝您提出問題，先生們。這絕對有幫助。

Thank you.

謝謝。

Thank you, Ben.

謝謝你，本。

Swayampakula Ramakanth, H.C. Wainwright.

斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth)，H.C.溫賴特。

Thank you. I have a couple of questions. The first one is on the research program, the gut-on-a-chip program. So with your relationship with the universities there, what are you planning to show, at least in '23, to see if you can get outside partnerships so that you can make this a commercializable product?

謝謝。我有一些問題。第一個是研究項目，即腸道芯片項目。那麼，根據您與那裡的大學的關係，您計劃至少在 23 年展示什麼，看看您是否可以獲得外部合作夥伴關係，以便將其變成可商業化的產品？

Sure. Thank you for the question, RK. We have developed a roadmap for this product. First of all, in terms of the collaboration, we are like the system integrators in the process. We have Tel Aviv University that are more related to the development of the chip itself, with the nano-electronics part. And the Sheba Hospital is bringing their -- they are contributing by bringing the organoids from the patients and basically providing the clinical support. We have a gastroenterologist, which is an expert in this field, that is part of the team.

當然。謝謝你的提問，RK。我們已經為此產品製定了路線圖。首先，在協作方面，我們就像是這個過程中的系統集成商。我們有特拉維夫大學，它更多地與芯片本身的開發有關，包括納米電子部分。舍巴醫院正在帶來他們的——他們通過從患者身上獲取類器官並基本上提供臨床支持來做出貢獻。我們團隊中有一位胃腸病學家，他是該領域的專家。

So what we are doing is basically, we are doing in a process where we start, first of all, with developing of a healthy tissue model. And then, we'll use the colitis on this model. And eventually, the idea here is that by the end of '24, we will have proof of concept of this model.

所以我們所做的基本上是，我們首先從開發健康組織模型開始。然後，我們將在這個模型上使用結腸炎。最終，這裡的想法是，到 24 年底，我們將獲得該模型的概念證明。

The [powders] might be different partners that might be for drug discovery. These are the big pharma companies. But our main goal, or main target, is to take it to personalized medicine, which is the much bigger market opportunity.

[粉末]可能是用於藥物發現的不同夥伴。這些都是大型製藥公司。但我們的主要目標，或者說主要目標，是將其應用於個性化醫療，這是更大的市場機會。

In this case, we believe that in the future, there will be service providers that will basically get from us a printed chip which is mimicking the tissue structure. And then they'll take biopsy from the patient, extract the cells, [see] the scaffold that we have in the chip with the cells -- the patient cells. And basically, after some incubation time to do the screening of the drug or optimize a dose of a certain drug or check different drugs. And eventually, we come up with the most ideal solution for the patient.

在這種情況下，我們相信將來會有服務提供商基本上從我們這裡獲得模仿組織結構的印刷芯片。然後他們將從患者身上進行活檢，提取細胞，[查看]芯片中帶有細胞的支架——患者細胞。基本上，經過一段時間的潛伏期後，進行藥物篩選或優化某種藥物的劑量或檢查不同的藥物。最終，我們為患者提出了最理想的解決方案。

And later on, after the colitis, we plan to expand the use to metabolism and also to colon cancer. So this is the plan. So going back to your original question, RK, by the end of 2024, we want to have a demonstration of a working model of this gut-on-a-chip tissue model.

之後，在結腸炎之後，我們計劃將其用途擴大到新陳代謝和結腸癌。這就是計劃。回到你最初的問題，RK，到 2024 年底，我們希望演示這種芯片上腸道組織模型的工作模型。

Fantastic. And then on those -- on the inks, on the bioinks, the different [buy] that you're talking about that you want to convert in the commercial portfolio. So with the one which is in the market now, the 3D 50L, what are you learning in terms of people using it? And how do you see that growing in terms of revenues, not only this product, but also the later projects that you're looking at, the 3D 50 and the 3D 90?

極好的。然後是關於墨水、生物墨水、您正在談論的想要在商業組合中轉換的不同[購買]。那麼，對於現在市場上銷售的 3D 50L，您從使用它的人們身上學到了什麼？您如何看待收入的增長，不僅是這個產品，還有您正在關注的後續項目，3D 50 和 3D 90？

Yeah. So first of all, let me say something about the strategy. We are now in a stage of positioning our technology of the bioinks as the gold standard in the industry. In order to do that, we are creating building blocks for bioinks.

是的。首先，讓我談談策略。我們現在正處於將我們的生物墨水技術定位為行業黃金標準的階段。為了做到這一點，我們正在創建生物墨水的構建模塊。

So for each indication, you need to use a proprietary customized biological ink formulation. And for this reason, we give the researchers today -- most of the yields are in the academia, of course, or in the companies in the development stage of a certain indication. We give them like a menu of building blocks that they can check and basically select the proper components and assemble their own bioink.

因此，對於每種適應症，您都需要使用專有的定制生物墨水配方。出於這個原因，我們今天給研究人員的成果——當然，大部分成果都在學術界，或者在處於某種適應症發展階段的公司。我們給他們提供了一個構建塊菜單，他們可以檢查並基本上選擇合適的組件並組裝自己的生物墨水。

So we got, so far, a very good feedback from our customers in the academia. They are using it in a variety of printing technologies. And basically, the uses are different. Some of them are on soft tissue applications. Some of them, hard tissue. Some of them are doing drug discovery. And then we (inaudible) also in the cells with this product.

因此，到目前為止，我們從學術界的客戶那裡得到了非常好的反饋。他們將其用於各種印刷技術。基本上，用途是不同的。其中一些用於軟組織應用。其中一些是硬組織。他們中的一些人正在進行藥物發現。然後我們（聽不清）也在細胞中使用了這種產品。

Okay, very good. That's all I have for you folks. Thank you.

好的，非常好。這就是我為你們準備的一切。謝謝。

Thank you, RK.

謝謝你，RK。

I believe that is our last question from our live audience participants. So now, I'll turn it back to Mr. Rotem for any questions that came in online.

我相信這是現場觀眾提出的最後一個問題。現在，我將把網上提出的任何問題轉回 Rotem 先生。

Thank you. So I have, currently, two questions. So I'll address them. The first one is coming from Mr. [Levy] in the increase in revenues. We see that revenues are up versus last year. Can you elaborate why? Who was the customer? And what do you expect the trend will be?

謝謝。所以我目前有兩個問題。所以我會向他們講話。第一個是來自[Levy]先生的收入增長。我們看到收入比去年有所增加。你能詳細說明一下原因嗎？顧客是誰？您預計趨勢會是什麼？

Okay. So the revenues in the first quarter, including income from the sales of the company's rhCollagen, it's a significant ramp up from last year. And the majority of the sales are from one of the strategic business partner of CollPlant.

好的。因此，第一季度的收入，包括該公司 rhCollagen 的銷售收入，比去年有顯著增長。大部分銷售額來自 CollPlant 的戰略業務合作夥伴之一。

Note that in 2022, CollPlant did not receive any milestone payments, and we do expect to receive the first milestone of this -- the first of these milestones in 2023. I cannot elaborate -- disclose the name of the customer. But it's a strategic partner that is responsible for the majority of the sales.

請注意，2022 年，CollPlant 沒有收到任何里程碑付款，我們確實希望收到第一個里程碑付款——第一個里程碑是在 2023 年。我無法詳細說明——請透露客戶的姓名。但它是一個戰略合作夥伴，負責大部分銷售。

The second question is coming for a Mr. [Dawn]. The question is, what will trigger the right of first negotiation for the filler application product, which AbbVie have been granted by the company? Is there a time and duration for this right?

第二個問題是針對[Dawn]先生的。問題是，什麼會觸發艾伯維公司授予的填充劑應用產品的優先談判權？這項權利有時間和期限嗎？

So this question is referring to what Yehiel described earlier as the third generation of the dermal filler. The one that is photocurable one that is doing the contouring. And as said by Mr. Dawn, it has the right of first negotiation.

所以這個問題指的是 Yehiel 之前描述的第三代真皮填充劑。一種是可光固化的，可以進行輪廓塑造。而且正如黎明先生所說，它擁有優先談判的權利。

There is a mechanism in the agreement that includes timelines. Unfortunately, we cannot disclose more than that about what exactly -- what we are doing along -- as you can see, along the last year, we are updating the market and the public regarding the progress in the development.

協議中有一個包括時間表的機制。不幸的是，我們無法透露更多關於我們正在做什麼的信息，正如您所看到的，去年我們正在向市場和公眾通報開發進展情況。

During the last 12 months, we announced some news from a preclinical study. And eventually, we will have to -- we will reach the point where we will have news about exercising that kind of the right or not. So at this point, we are in obviously in the development as mentioned.

在過去 12 個月中，我們宣布了一些臨床前研究的消息。最終，我們將不得不——我們將達到這樣的程度：我們將獲得有關是否行使此類權利的新聞。所以在這一點上，我們顯然正處於如上所述的開發階段。

That concludes our questions from the audience. I will now turn the call back to Yehiel Tal, CollPlant's CEO, for any closing remarks. Yehiel?

觀眾的提問到此結束。現在我將把電話轉回給 CollPlant 首席執行官 Yehiel Tal，讓其作結束語。葉希爾？

Thank you, Eran. As I've stated, we, at CollPlant, aspire to become leaders in regenerative medicine, helping people live longer and better, and creating improvements in science through our regenerative technology.

謝謝你，埃蘭。正如我所說，我們 CollPlant 立志成為再生醫學領域的領導者，幫助人們活得更長、活得更好，並通過我們的再生技術推動科學進步。

Our goal is to create better alternatives and options for the future, such as an unlimited supply of spare parts for the human body, including life-saving organs, medical treatment data for the individual characteristics of each patient, and drug developed without the need for animal testing.

我們的目標是為未來創造更好的替代方案和選擇，比如無限量地供應人體備件，包括救生器官、針對每個患者個體特徵的醫療數據以及無需人工干預而開發的藥物。動物測驗。

As mentioned, our vision is to enable a world with unlimited organ supply, regenerative tissue products, and novel drugs and diagnostics that do not rely on animals. We are confident that our collaboration with worldwide pharmaceutical leaders as well as other numerous collaborations and partnership agreements has validated our technology and its multiple areas of applicability.

如前所述，我們的願景是打造一個擁有無限器官供應、再生組織產品以及不依賴動物的新型藥物和診斷方法的世界。我們相信，我們與全球製藥領導者的合作以及其他眾多的合作和夥伴關係協議已經驗證了我們的技術及其多個領域的適用性。

In closing, I want to reiterate our upcoming goals for 2023: continue to advance development of paradigm-shifting regenerative dermal and soft tissue fillers with AbbVie, expecting first milestone achievement in 2023; initiate study in large animals with commercial-sized implants to regenerate additional safety data in support of commercialization; advance development of the gut-on-a-chip tissue model of drug discovery and personalized treatment of ulcerative colitis; continue to expand our commercial portfolio of bioink -- of rhCollagen-based bioinks; form new collaborations with industry leaders to co-develop therapeutics and medical applications.

最後，我想重申我們即將到來的 2023 年目標：繼續與艾伯維 (AbbVie) 一起推進範式轉變的再生真皮和軟組織填充劑的開發，預計在 2023 年取得第一個里程碑式的成就；啟動具有商業尺寸植入物的大型動物研究，以重新生成額外的安全數據以支持商業化；推進藥物發現和潰瘍性結腸炎個性化治療的芯片腸道組織模型的開發；繼續擴大我們的生物墨水商業組合——基於 rhCollagen 的生物墨水；與行業領導者建立新的合作，共同開發治療和醫療應用。

And I would like to thank you, everyone, for joining us on today's conference call.

我要感謝大家參加今天的電話會議。

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.

今天的會議到此結束。此時您可以斷開線路，我們感謝您的參與。