Thermogenesis Holdings Inc (THMO) 2022 Q4 法說會逐字稿

Good day, and welcome to the ThermoGenesis Holdings conference call webcast to review financial and operating results for the year ended December 31, 2022. (Operator Instructions) As a reminder, this conference call is being recorded.

美好的一天，歡迎收看 ThermoGenesis Holdings 電話會議網絡直播，回顧截至 2022 年 12 月 31 日止年度的財務和經營業績。（操作員說明）提醒一下，本次電話會議正在錄製中。

I would now like to turn conference over to our host, Paula Schwartz of Rx Communications. Please go ahead.

我現在想把會議轉交給我們的主持人，Rx Communications 的 Paula Schwartz。請繼續。

Thank you, operator. This conference call contains forward-looking statements within the meaning of the Federal Securities Laws. The company's actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that might cause actual results to differ materially from those in the forward-looking statements is contained in the company's periodic reports filed with the Securities and Exchange Commission.

謝謝你，運營商。本次電話會議包含聯邦證券法含義內的前瞻性陳述。公司的實際結果可能與前瞻性陳述中預測的結果存在重大差異。有關可能導致實際結果與前瞻性陳述中的結果存在重大差異的因素的更多信息包含在公司向美國證券交易委員會提交的定期報告中。

The information presented today is time-sensitive and is accurate only as of the date of this call, March 30, 2023. If any portion of this call is being rebroadcast, retransmitted, or redistributed at a later date, ThermoGenesis will not be reviewing or updating this material.

今天提供的信息具有時效性，並且僅在 2023 年 3 月 30 日本次電話會議之日準確。如果本次電話會議的任何部分在以後被轉播、重新傳輸或重新分發，ThermoGenesis 將不會審查或更新此材料。

Participating on today's call are Dr. Chris Xu, Chief Executive Officer, and Jeff Cauble, Chief Financial Officer.

參加今天電話會議的有首席執行官 Chris Xu 博士和首席財務官 Jeff Cauble。

I'd now like to turn the call over to Chris. Please go ahead, Chris.

我現在想把電話轉給克里斯。請繼續，克里斯。

Thank you, Paula, and thank you to everyone for joining the call this afternoon. We appreciate you taking the time to listen in. During 2022, and thus far in 2023, we took important steps towards executing our plans to transform ThermoGenesis from a medical device company to a contract development and manufacturing organization, or CDMO, for the cell and gene therapy market.

謝謝 Paula，也感謝大家今天下午加入電話會議。感謝您抽出時間聆聽我們的意見。在 2022 年和 2023 年到目前為止，我們採取了重要步驟來執行我們的計劃，將 ThermoGenesis 從一家醫療設備公司轉變為合同開發和製造組織 (CDMO)，用於細胞和基因治療市場。

In October 2022, we completed an approximately $2.0 million financing and recently completed another $3.0 million private placement transaction. These finances will support the planned launch of our CDMO business through which we will leverage our unique and proprietary automated and semi-automated cell processing platforms, including the CAR-TXpress platform.

2022 年 10 月，我們完成了約 200 萬美元的融資，最近又完成了另一筆 300 萬美元的私募交易。這些資金將支持我們計劃啟動的 CDMO 業務，我們將通過該業務利用我們獨特和專有的自動化和半自動化細胞處理平台，包括 CAR-TXpress 平台。

Our goal is to help companies and institutions to develop next-generation cancer medicines, such as cell gene therapies, to accelerate drug candidates into clinics as quickly and safely as possible. Our focus will be to establish solutions for customers in order to streamline supply chain, increasing manufacturing predictabilities, and manage overall risks.

我們的目標是幫助公司和機構開發下一代癌症藥物，例如細胞基因療法，以盡可能快速和安全地加速候選藥物進入臨床。我們的重點將是為客戶建立解決方案，以簡化供應鏈、提高製造的可預測性並管理整體風險。

To that end, we recently announced the roll out of ReadyStart cGMP Suites, available for lease by early-stage life science and cell gene therapy companies, expected to be available to customers in the second and third quarter of this year.

為此，我們最近宣布推出 ReadyStart cGMP Suites，可供早期生命科學和細胞基因治療公司租賃，預計將於今年第二和第三季度提供給客戶。

Before I [devolve] further into our progress, I want to remind you of where we come from. ThermoGenesis has proven its ability to pioneer the development and production of a long list of cutting-edge automated technologies and products for the cell banking and cell therapy industry.

在我[深入]進一步討論我們的進展之前，我想提醒你我們來自哪裡。 ThermoGenesis 已證明其有能力率先為細胞庫和細胞治療行業開發和生產一系列尖端自動化技術和產品。

For many years, ThermoGenesis has been the provider of the choice of automated cell processing and automated smart cryogenic storage technologies for some of the world's most important public and private banks. Our BioArchive cryo-storage system has warehoused close to 90% of all US FDA BLA approved clinical-grade cord blood units. And our AXP system has been utilized by approximately close to 130 institutes across the world and has processed well over a million samples thus far.

多年來，ThermoGenesis 一直是世界上一些最重要的公共和私人銀行的自動化細胞處理和自動化智能低溫存儲技術選擇的供應商。我們的 BioArchive 低溫儲存系統儲存了近 90% 的美國 FDA BLA 批准的臨床級臍帶血單位。我們的 AXP 系統已被全球近 130 家研究所使用，迄今為止已處理了超過一百萬個樣本。

The intellectual properties we have accumulated over our history is invaluable, and we are excited about the future. Driving our forward-looking strategy in large part is the continued growth and industry focus on the potential for personalized cell and gene therapy.

我們在歷史上積累的知識產權是無價的，我們對未來感到興奮。在很大程度上推動我們前瞻性戰略的是持續增長和行業對個性化細胞和基因治療潛力的關注。

Since 2017, six autologous CAR-T therapies has been approved by the FDA. While CAR-T therapies were initially approved as the last line of defense, more recently, there have been CAR-T trials that have shown that these therapies can outperform second-line standard-of-care options, which could expand its applications in the future.

自 2017 年以來，已有 6 種自體 CAR-T 療法獲得 FDA 批准。雖然 CAR-T 療法最初被批准作為最後一道防線，但最近的 CAR-T 試驗表明，這些療法可以優於二線標準護理選項，這可以擴大其在未來。

Recent report shows that the industry anticipates additional FDA approvals with as many as 10 to 20 new therapies each year, starting in 2025. As the demand for cell gene therapies continue to explode, there are now an estimated over 350 US companies alone working in cell therapy arena and more than 1,000 pipeline assets in clinical development globally, targeting a variety of blood and solid tumors.

最近的報告顯示，從 2025 年開始，該行業預計每年有多達 10 到 20 種新療法獲得 FDA 的額外批准。隨著對細胞基因療法的需求持續激增，現在估計有超過 350 家美國公司在細胞領域工作治療領域和全球臨床開發中的 1,000 多個管道資產，針對各种血液和實體瘤。

Unfortunately, the surge in clinical activity has not been matched by an increase in production capacity. Even though over 70% of all cell and gene therapies companies outsource their manufacturing needs, only a fraction of their required capacity exists in the marketplace today, creating a critical 12 to 18 months backlog in commercial manufacturing. This will only be exacerbated by accelerated approvals in the coming days.

不幸的是，臨床活動的激增並沒有伴隨著生產能力的增加。儘管超過 70% 的細胞和基因療法公司將其製造需求外包，但如今市場上只存在其所需產能的一小部分，導致商業製造中出現關鍵的 12 至 18 個月積壓。未來幾天加速批准只會加劇這種情況。

These dynamics have led to a rise in CDMO partnership activities as more and more biopharmaceutical companies and other industrial participants recognize the urgency of the increased demands for cell therapy and the limited availability of the cGMP facilities.

隨著越來越多的生物製藥公司和其他行業參與者認識到細胞治療需求增加的緊迫性和 cGMP 設施的可用性有限，這些動態導致 CDMO 合作活動的增加。

Moving forward from manual process will be a key to facilitating faster timelines and getting these life-saving drugs from bench to bedside. At the same time, there are the main critical and growing unmet needs for manufacturing of these contract centerpiece due to continued challenges created by high production cost, technological inefficiencies, and limited global capacities.

從手動過程向前發展將是促進更快的時間表並將這些救生藥物從工作台送到床邊的關鍵。與此同時，由於高生產成本、技術效率低下和全球產能有限帶來的持續挑戰，製造這些合同核心部件的主要關鍵需求和不斷增長的未滿足需求。

Drug manufacturing today is still the largest component of the cost of CAR-T cell therapies. As a result, there is a significant need for high-quality cGMP manufacturing at a reasonable cost. Additionally, there are not a lot of the CDMOs that are well equipped to handle the process that is required for cell gene therapy manufacturing. And it takes years for companies to build their own facilities.

今天的藥物製造仍然是 CAR-T 細胞療法成本的最大組成部分。因此，迫切需要以合理的成本進行高質量的 cGMP 生產。此外，沒有很多 CDMO 能夠很好地處理細胞基因治療製造所需的過程。公司需要數年時間才能建立自己的設施。

The need for cGMP manufacturing of this extremely complex, personalized, and life-saving therapies is as important as ever. ThermoGenesis will look to address the growing need for CDMO service by providing high-quality development and manufacturing capacities, cell and tissue processing development, quality system, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various stage of development.

這種極其複雜、個性化和挽救生命的療法對 cGMP 製造的需求與以往一樣重要。 ThermoGenesis 將通過為處於不同開發階段的候選治療藥物的客戶提供高質量的開發和製造能力、細胞和組織加工開發、質量體系、法規遵從性和其他細胞製造解決方案，來滿足對 CDMO 服務不斷增長的需求。

Specifically, we will leverage our unique cell processing technologies such as CAR-TXpress platform, combined with our existing in-house expertise to provide valuable solutions for clients with therapeutic candidates.

具體來說，我們將利用我們獨特的細胞處理技術，如 CAR-TXpress 平台，結合我們現有的內部專業知識，為具有治療候選人的客戶提供有價值的解決方案。

Taken together, our line of products and services will be specifically designed to provide the flexibility needed to deal with uncertainty at every stage of the process. As recently announced, we are building out our approximately 35,000 square feet of laboratory and office space in Sacramento, California, which includes 12 ReadyStart class-7 cGMP cleanroom suites to support the industry's manufacturing requirements.

總而言之，我們的產品和服務系列將專門設計用於提供處理流程每個階段的不確定性所需的靈活性。正如最近宣布的那樣，我們正在加利福尼亞州薩克拉門托建造我們大約 35,000 平方英尺的實驗室和辦公空間，其中包括 12 個 ReadyStart 7 級 cGMP 潔淨室套件，以支持行業的製造要求。

This ReadyStart cGMP Suite will be available for lease by early-stage life science and cell gene therapy companies. Importantly, the ReadyStart suites will meet the highest scientific quality and regulatory requirements and are ideal for early-stage companies looking to jump-start their development efforts and/or to scale up in the same facility with a turnkey solution.

這個 ReadyStart cGMP Suite 將可供早期生命科學和細胞基因治療公司租用。重要的是，ReadyStart 套件將滿足最高的科學質量和監管要求，非常適合希望快速啟動開發工作和/或使用交鑰匙解決方案在同一設施中擴大規模的早期公司。

Further, the suites will eliminate a tremendous resource burden and greatly accelerate the development cycle by allowing the resident companies to focus on their own core science. Our all-encompassing ReadyStart cGMP Suite will provide a flexible option, enable companies to achieve their anticipated milestones faster and more efficiently.

此外，這些套件將消除巨大的資源負擔，並通過允許入駐公司專注於自己的核心科學來大大加快開發週期。我們包羅萬象的 ReadyStart cGMP 套件將提供靈活的選擇，使公司能夠更快、更高效地實現預期的里程碑。

Additionally, our team's strong expertise in regulatory affair and product commercialization will help accelerate the development of our customers' products, allowing them to focus on their own science while ThermoGenesis will manage the regulatory and quality compliance associated with running a GMP facility.

此外，我們團隊在法規事務和產品商業化方面的深厚專業知識將有助於加速我們客戶產品的開發，使他們能夠專注於自己的科學，而 ThermoGenesis 將管理與運行 GMP 設施相關的法規和質量合規性。

The ReadyStart cGMP Suites are expected to be available for customers in the second and third quarter of this year and, once fully leased, are expected to generate an additional annual revenue in the range of $10 million to $16 million. We look forward to reporting more on the progress in the coming months.

ReadyStart cGMP Suites 預計將於今年第二和第三季度向客戶提供，一旦全部租出，預計將產生 1000 萬至 1600 萬美元的額外年收入。我們期待在未來幾個月內報告更多進展情況。

And with that, let me turn the call over to Jeff to share some of the key financial result for the year. Jeff?

有了這個，讓我把電話轉給傑夫，分享今年的一些關鍵財務結果。傑夫？

Thank you, Chris. Net revenues were $10.5 million for the year ended December 31, 2022, up 13% from last year. The increase was driven by $1.3 million more in domestic AXP disposable sales. Gross profit for the year ended December 31, 2022 was $2.7 million or 26% of net revenues compared to $3.5 million or 38% of net revenues for 2021. The decrease was primarily due to higher costs from our AXP disposable contract manufacturer. In 2023, we transition to a new contract manufacturer and expect to see benefits of the lower pricing after we work through our existing inventory.

謝謝你，克里斯。截至 2022 年 12 月 31 日止年度的淨收入為 1050 萬美元，比去年增長 13%。這一增長是由國內 AXP 一次性銷售額增加 130 萬美元推動的。截至 2022 年 12 月 31 日止年度的毛利為 270 萬美元，占淨收入的 26%，而 2021 年為 350 萬美元，占淨收入的 38%。下降的主要原因是我們的 AXP 一次性合同製造商的成本增加。 2023 年，我們將過渡到一家新的合同製造商，並希望在我們處理現有庫存後看到較低定價的好處。

Selling, general and administrative expenses were $7.2 million for the year ended December 31, 2022, as compared to $8.5 million for 2021. The decrease was driven by lower stock compensation expense, offset by rent expense for the new CDMO facility acquired by the company in April 2022. Research and development expenses were $1.7 million for the year ended December 31, 2022, as compared to $2.2 million for 2021. The decrease was also driven by reduced stock compensation expense.

截至 2022 年 12 月 31 日止年度，銷售、一般和管理費用為 720 萬美元，而 2021 年為 850 萬美元。減少的原因是股票補償費用減少，被公司於 2018 年收購的新 CDMO 設施的租金費用所抵消2022 年 4 月。截至 2022 年 12 月 31 日止年度，研發費用為 170 萬美元，而 2021 年為 220 萬美元。減少的另一個原因是股票補償費用減少。

For the year ended December 31, 2022, the company recorded a comprehensive loss attributable to common stockholders of $11.2 million or $20.45 per share based on approximately 550,000 weighted average shares outstanding. This compares to a comprehensive net loss of $11.4 million or $43.41 per share based on approximately 262,000 weighted average shares outstanding for the year ended December 31, 2021.

截至 2022 年 12 月 31 日止年度，公司錄得普通股股東應佔綜合虧損 1120 萬美元或每股 20.45 美元，基於約 550,000 股加權平均流通股。相比之下，截至 2021 年 12 月 31 日止年度，根據約 262,000 股已發行加權平均股計算，綜合淨虧損為 1,140 萬美元或每股 43.41 美元。

At December 31, 2022, the company had cash and cash equivalents totaling $4.2 million compared with $7.3 million at December 31, 2021. Also, as Chris mentioned, last week, we closed a private placement sale of common stock and associated warrants, raising gross proceeds of approximately $3 million. We intend to utilize the proceeds for working capital and to support our transition to become a CDMO for gene therapy companies.

截至 2022 年 12 月 31 日，公司的現金和現金等價物總額為 420 萬美元，而 2021 年 12 月 31 日為 730 萬美元。此外，正如克里斯提到的，上週我們完成了普通股和相關認股權證的私募銷售，提高了毛收益約300萬美元。我們打算將所得款項用於營運資金，並支持我們轉型為基因治療公司的 CDMO。

This concludes our prepared remarks. So now we'd like to open the call for your questions. Operator?

我們準備好的發言到此結束。所以現在我們想打開您的問題的電話。操作員？

Yes. Thank you. (Operator Instructions) Sean Lee, H.C. Wainwright.

是的。謝謝。 （操作員說明）Sean Lee，H.C.溫賴特。

Good afternoon, guys, and thanks for taking my questions. It's great to hear that the CDMO business is ready to get started and running. I was just wondering whether you can provide some details on how you would be operating this segment. Firstly, what is the business model in terms of leasing out these CDMO facilities? Would it be by product line, by room? And are there different tiers based on whether they use their own manufacturing technology or use the cell (inaudible)?

下午好，伙計們，謝謝你提出我的問題。很高興聽到 CDMO 業務已準備好啟動和運行。我只是想知道你是否可以提供一些關於你將如何經營這個部門的細節。首先，出租這些 CDMO 設施的商業模式是什麼？是按產品線還是按房間？根據他們是使用自己的製造技術還是使用電池（聽不清），是否有不同的等級？

Hi, Sean, this is Chris, and thank you for the question. And just to address the first part of the question with regards to the models that we are running, so ThermoGenesis eventually is running the CDMO as a third-party manufacturer, which means we are manufacturing the final products for the developers.

嗨，肖恩，我是克里斯，謝謝你提出這個問題。只是為了解決關於我們正在運行的模型的問題的第一部分，因此 ThermoGenesis 最終將作為第三方製造商運行 CDMO，這意味著我們正在為開發人員製造最終產品。

At this moment, which we still consider a transition period moving from a medical device to the CDMO service, we offer those extra cGMP rooms as a lease, which is one of the options for the drug developers because certainly we'd realize that the market has a huge, very huge, need for that. So that's kind of a hybrid model which we lease some of the rooms for the developers if they want to have their own scaled-up process just by using our cGMP facilities.

此刻，我們仍然認為這是從醫療設備到 CDMO 服務的過渡期，我們提供這些額外的 cGMP 房間作為租賃，這是藥物開發商的選擇之一，因為我們當然會意識到市場有一個巨大的，非常巨大的需求。所以這是一種混合模型，如果開發人員想通過使用我們的 cGMP 設施來擁有自己的放大過程，我們會為開發人員租用一些房間。

But we also provide a full white-glove service which encompass everything from process development to GMP manufacturing, to vector manufacturing and design, to quality system design, and also including the facilitation of their FDA regulatory filings. So we can be, from one end, a simple solution by providing the GMP to them just by operating as a facilitator, or through a full service, which providing a comprehensive white-glove service to early stage or mid-stage companies. Does that help?

但我們還提供全面的白手套服務，涵蓋從工藝開發到 GMP 製造、載體製造和設計、質量系統設計的所有內容，還包括協助他們提交 FDA 監管文件。因此，從一端來看，我們可以成為一個簡單的解決方案，通過作為促進者或通過全面服務向他們提供 GMP，從而為早期或中期公司提供全面的白手套服務。這有幫助嗎？

Yeah, that was very helpful. Thank you. Just in that case, I think in the prepared remarks, you mentioned if fully leased, you can expect -- we can expect revenues of between $10 million and $16 million from these facilities. Is that the range coming from the differences in the services that you offer?

是的，這很有幫助。謝謝。在那種情況下，我想在準備好的發言中，你提到如果完全出租，你可以預期——我們可以預期這些設施的收入在 1000 萬到 1600 萬美元之間。該範圍是否來自您提供的服務的差異？

The $10 million to $15 million is just based on the lease option. Basically we provide -- assuming that it's fully leased out, we are providing facilitation [just] maintaining that regulatory compliance and quality compliance for the GMP facility. So it doesn't include in any of the higher, more comprehensive service model that we intend to provide.

1000 萬到 1500 萬美元只是基於租賃選項。基本上我們提供 - 假設它已完全出租，我們正在提供便利[只是]維護 GMP 設施的監管合規性和質量合規性。因此，它不包含在我們打算提供的任何更高、更全面的服務模型中。

I see. So the other stuff will be on top of this [venture].

我懂了。所以其他的東西將在這個[冒險]之上。

Yeah.

是的。

Assuming that the facility is fully leased out, what sort of gross margins can we expect from these services?

假設設施全部出租，我們可以從這些服務中獲得什麼樣的毛利率？

At this moment, we are still trying to finalize the number. Certainly, this will be in par with the industry average or a little higher. So at this moment, we cannot give the forecasting yet, but we are working around the clock trying to get a sense of the range. But I guess this will be in par with the industry average.

目前，我們仍在努力確定這個數字。當然，這將與行業平均水平持平或略高一些。所以目前，我們還不能給出預測，但我們正在夜以繼日地工作，試圖了解範圍。但我想這將與行業平均水平持平。

Okay. That's fine. And my final question to you is, what outreach activities are you doing to help attract companies to these new facilities and get them to start using perhaps your own [CAR-TXpress systems] as well?

好的。沒關係。我要問你的最後一個問題是，你正在開展哪些外展活動來幫助吸引公司使用這些新設施，並讓他們也開始使用你自己的 [CAR-TXpress 系統]？

Sure. So we are taking multiple -- kind of multiple strategy in reaching out to our customers, which including some of the very traditional reaching out, such as marketing, advertising in professional magazines such as the Nature, such as science magazine. But we're also reaching out through standard digital media and other facilitator in term of a professional broker in this space. So we are taking multiple approach to reach out to our customer.

當然。因此，我們正在採取多種 - 多種策略來接觸我們的客戶，其中包括一些非常傳統的接觸，例如營銷，在自然雜誌等專業雜誌上做廣告，如科學雜誌。但我們也通過標準數字媒體和其他促進者在這個領域的專業經紀人方面伸出援手。因此，我們正在採取多種方法來接觸我們的客戶。

Great. That's all the questions I have, and thanks again for taking my questions.

偉大的。這就是我的所有問題，再次感謝您提出我的問題。

You're welcome.

不客氣。

Thank you. And this concludes our question-and-answer session. I will now turn the conference back over to Dr. Xu for any closing comments.

謝謝。我們的問答環節到此結束。我現在將把會議轉回徐博士聽取任何閉幕評論。

Thank you, operator. We look forward to updating you on our progress during our first-quarter 2023 call, and thank you to everyone who participated today and for your interest in ThermoGenesis Holdings.

謝謝你，運營商。我們期待在 2023 年第一季度的電話會議上向您通報我們的最新進展，並感謝今天參加的所有人以及您對 ThermoGenesis Holdings 的關注。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開線路。