Thermogenesis Holdings Inc (THMO) 2023 Q2 法說會逐字稿

Good day, and welcome to the ThermoGenesis Holdings conference call and webcast to review financial and operating results for the second quarter ended June 30, 2023. (Operator Instructions) As a reminder, this conference call is being recorded. I would now like to turn the conference over to our host, Paula Schwartz of Rx Communications. Please go ahead.

美好的一天，歡迎參加 ThermoGenesis Holdings 電話會議和網路廣播，回顧截至 2023 年 6 月 30 日的第二季財務和營運業績。（操作員說明）謹此提醒，本次電話會議正在錄音。現在我想將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 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，接線生。本次電話會議包含聯邦證券法意義內的前瞻性陳述。本公司的實際結果可能與前瞻性陳述中的預測有重大差異。有關可能導致實際結果與前瞻性陳述中的結果不同的因素的更多資​​訊包含在該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, August 10, 2023. If any portion of this call is being rebroadcast, retransmitted, or redistributed at a later date, ThermoGenesis will not be reviewing or updating its materials.

今天提供的資訊具有時效性，並且僅截至本次電話會議之日（2023 年8 月10 日）準確。如果本次電話會議的任何部分在以後重新廣播、重新傳輸或重新分發，ThermoGenesis 將不會進行審查或更新其資料。

Participating on today's call are Dr. Chris Xu, Chief Executive Officer; and Jeff Cauble, Chief Financial Officer. I would now like to turn the call over to Chris. Please go ahead.

執行長 Chris Xu 博士出席了今天的電話會議；和財務長 Jeff Cauble。我現在想把電話轉給克里斯。請繼續。

Thank you, Paula, and thank you to everyone for joining the call this afternoon. We appreciate you taking the time to listen in. During the second quarter, we continued to make progresses to transform from a medical device company to a CDMO cell manufacture for the cell and gene therapy market. Through which, we will leverage our unique and proprietary automated and semi-automated cell processing technologies, including the CAR-TXpress platform.

謝謝你，寶拉，也謝謝大家今天下午加入電話會議。感謝您抽出寶貴的時間聆聽。第二季度，我們繼續取得進展，從一家醫療器材公司轉型為細胞和基因治療市場的 CDMO 細胞製造商。透過該技術，我們將利用我們獨特的專有自動化和半自動化細胞處理技術，包括 CAR-TXpress 平台。

We are getting close to completion of the 12 ReadyStart current Good Manufacturing Practice suite or GMP suite at our 35,000 square feet GMP facility in Sacramento. These class-7 cleanrooms are designed for early-stage businesses and organizations striving to speed up the process to bringing novel cell gene therapies to clinical trials.

我們位於薩克拉門托 35,000 平方英尺的 GMP 工廠即將完成 12 個 ReadyStart 現行良好生產規範套件或 GMP 套件。這些 7 級無塵室專為早期企業和組織而設計，致力於加速將新型細胞基因療法引入臨床試驗的進程。

Our priority is to provide customers with solutions that optimize these supply chain, increasing manufacture [predictability], and manage overall risk. We have started advertising this turnkey solution to early-stage life science cell gene therapy companies, whose team want and need to expedite their development efforts from early 9 GMP-grade research.

我們的首要任務是為客戶提供最佳化供應鏈、提高製造[可預測性]並管理整體風險的解決方案。我們已開始向早期生命科學細胞基因治療公司宣傳這種交鑰匙解決方案，這些公司的團隊希望並且需要加快早期 9 GMP 級研究的開發工作。

We have continued to draw interest from potential customers for the state-of-art ReadyStart cGMP unit, which remain on target for availability, which is later this year. As most of you know, for over 35 years, ThermoGenesis has been spearheaded the advancement and production of a variety of revolutionary automated technologies and products tailored for the cell banking and cell therapy sector.

我們繼續吸引潛在客戶對最先進的 ReadyStart cGMP 裝置的興趣，該裝置仍按計劃於今年稍後上市。正如大多數人所知，35 年來，ThermoGenesis 一直引領著為細胞庫和細胞治療領域量身定制的各種革命性自動化技術和產品的開發和生產。

Indeed, ThermoGenesis has been the top choice for automated cell processing and state-of-art smart cryogenic storage technology for numerous renowned public and private cell banks globally. Our BioArchive file storage system has safeguarded nearly 90% of all US FDA BLA-approved clinical-grade core blood units or CBUs while our AXP system has been utilized to handle well over a million samples for approximately 130 institute globally.

事實上，ThermoGenesis 一直是全球眾多知名公共和私人細胞庫自動化細胞處理和最先進的智慧低溫儲存技術的首選。我們的 BioArchive 文件儲存系統已保護了近 90% 的美國 FDA BLA 批准的臨床級核心血液單位或 CBU，而我們的 AXP 系統已用於處理全球約 130 個研究所的超過一百萬個樣本。

In addition to our expertise in manufacturing cell gene therapies, the intellectual properties we have acquired over the years is extremely valuable. The driving force behind our transition to a CDMO is the ongoing growth and the industry emphasis on the potential of personalized cell gene therapies.

除了我們在製造細胞基因療法方面的專業知識外，我們多年來獲得的智慧財產權也非常有價值。我們向 CDMO 轉型的驅動力是持續成長和產業對個人化細胞基因療法潛力的重視。

Since 2017, FDA has approved six autologous CAR-T therapeutics, which have demonstrated unprecedented efficacy in patients with B-cell malignancy and multiple myeloma. Although CAR-Ts were initially authorized as the final result for patients who did not respond to alternative treatments, recent trials have demonstrated their ability to outperform second line stand apart -- a standard of care's options.

自2017年以來，FDA已批准了六種自體CAR-T療法，這些療法在B細胞惡性腫瘤和多發性骨髓瘤患者中表現出前所未有的療效。儘管 CAR-T 最初被授權作為對替代療法沒有反應的患者的最終結果，但最近的試驗表明，它們有能力超越二線療法——一種標準的護理選擇。

This suggests that the scope of applications for CAR-T therapies may expand in the future. Recent result -- recent reports indicate that the industry expects additional FDA approvals with potential 10 to 20 new CAR-T therapies approved for commercialization each year starting in 2025.

這表明CAR-T療法的應用範圍未來可能會擴大。最近的結果——最近的報告表明，業界預計 FDA 將獲得更多批准，從 2025 年開始，每年可能有 10 至 20 種新的 CAR-T 療法獲準商業化。

As I have noted previously, with the rise in FDA-approved and regenerative medicine treatments and CAR-T therapies, there is an increasing need for the production of these life-saving therapies. Presently, there are over 350 US companies exclusively focused on cell therapy research and development. And there are more than 1,000 pipeline asset in clinical trials worldwide, specifically targeting a wide range of blood and solid tumors.

正如我之前指出的，隨著 FDA 批准的再生醫學治療和 CAR-T 療法的興起，對生產這些挽救生命的療法的需求不斷增加。目前，有超過350家美國公司專門專注於細胞療法的研發。全球有超過 1,000 個處於臨床試驗階段的管道資產，專門針對廣泛的血液和實體腫瘤。

This exponential growth in R&D is being abled by the remarkable potential inherited in already available therapies, alongside the promising prospect provided by personalized cell and gene therapies. With thousands of preclinical and clinical trials currently being conducted, there is an unprecedented demand for high-quality and reliable CDMO services.

研發的指數級成長得益於現有療法所繼承的巨大潛力，以及個人化細胞和基因療法所提供的廣闊前景。目前正在進行數千項臨床前和臨床試驗，對高品質和可靠的 CDMO 服務的需求前所未有。

Moreover, as I have noted many times, approved CAR-T cell therapies in the US tends to pass between approximately $373,000 to $475,000 per dose, making them one of the most expensive drug classes on the market. Significantly, the manufacturing cost for just one dose of some CAR-T therapeutics exceeds $100,000, with 79% of which attribute it to label -- to labor and GMP facility expenses.

此外，正如我多次指出的那樣，美國批准的 CAR-T 細胞療法每劑價格往往在 373,000 美元至 475,000 美元之間，這使它們成為市場上最昂貴的藥物類別之一。值得注意的是，一些 CAR-T 療法僅一劑的製造成本就超過 10 萬美元，其中 79% 歸因於標籤、勞動力和 GMP 設施費用。

Given these dynamics, developers needs to tackle the issue of producing high-quality clinical-grade cell therapies at a commercial scale, which will enable more patients to benefit from these revolutionary treatments. We strongly believe that the CAR-TXpress platform we have, holds the potential to considerably reduce processing time, enhancing cell recovery rates, and effectively lowering the manufacturing cost for CAR-T and other cell gene therapies.

鑑於這些動態，開發人員需要解決以商業規模生產高品質臨床級細胞療法的問題，這將使更多患者受益於這些革命性的治療方法。我們堅信，我們擁有的 CAR-TXpress 平台有潛力大幅縮短處理時間，提高細胞回收率，並有效降低 CAR-T 和其他細胞基因療法的製造成本。

Through our CDMO services, we offer a high-quality development and manufacturing capacities as well as cell and tissue processing development quality system, regulatory compliance, and other cell manufacturer solutions for clients with therapeutic candidates in different stage of development. As mentioned, an integral aspect of this plan is leveraging our proprietary high efficient CAR-TXpress platform, which has demonstrated its ability to significantly reduce processing time, enhancing cell recovery rate, and potentially, cut manufacturing costs associated with CAR-T and other cell gene therapies by up to 50%.

透過我們的CDMO服務，我們為處於不同開發階段的候選治療藥物的客戶提供高品質的開發和製造能力，以及細胞和組織加工開發品質系統、法規合規性和其他細胞製造商解決方案。如前所述，該計劃的一個組成部分是利用我們專有的高效CAR-TXpress 平台，該平台已證明其能夠顯著縮短處理時間，提高細胞回收率，並有可能降低與CAR-T 和其他細胞相關的製造成本基因療法的效率高達 50%。

Additionally, by utilizing our comprehensive cell therapy portfolio, we intend to provide clients with the benefit of our extensive expertise in variety of cell types such as chimeric antigen receptor T cells, TCRT, and tumor-infiltrating leukocytes, natural killer cells, and including other cells such as inducible pluripotent stem cells and mesenchymal stem cells. Our all-encompassing ReadyStart cGMP suite provide a versatile solution, allowing companies to reach their projected milestone faster and more efficiently.

此外，透過利用我們全面的細胞治療產品組合，我們打算為客戶提供我們在各種細胞類型方面的廣泛專業知識，例如嵌合抗原受體T 細胞、TCRT 和腫瘤浸潤白血球、自然殺手細胞，以及其他細胞類型。細胞，例如誘導性多能幹細胞和間質幹細胞。我們包羅萬象的 ReadyStart cGMP 套件提供了多功能解決方案，使公司能夠更快、更有效率地達到其預期里程碑。

Additionally, our team's expertise in regulatory affair and product commercialization should accelerate the development of our customers' product, allowing them to focus on their research while we manage the regulatory and quality compliance aspect associated with operating cGMP unit. In the second quarter, we invited two additional member to our Board of Directors, Dr. Biao Xi and Dr. James Xu.

此外，我們團隊在監管事務和產品商業化方面的專業知識應能加速客戶產品的開發，使他們能夠專注於研究，同時我們管理與營運 cGMP 部門相關的監管和品質合規方面。第二季度，我們邀請了另外兩位董事會成員，席彪博士和徐博士。

Biao is a highly regarded life-science executive with extensive expertise in biopharmaceutical research and drug development. And James brings strong legal IP and business acumen, including more than 25 years in the field of patent, corporate law, and tax law. Their contributions are highly valuable to the company. And with that, let me turn the call over to Jeff to hear the key financial result for the second quarter. Jeff?

飚先生是一位備受推崇的生命科學高管，在生物製藥研究和藥物開發方面擁有豐富的專業知識。 James 擁有強大的法律智慧財產權和商業頭腦，包括在專利、公司法和稅法領域擁有超過 25 年的經驗。他們的貢獻對公司來說非常有價值。接下來，讓我把電話轉給傑夫，聽聽第二季的主要財務結果。傑夫？

Thank you, Chris. A full discussion of our financials is available in the press release and 10-Q. So I'll just take a moment to review key financials for the quarter ended June 30, 2023. Net revenues were $2.3 million for the quarter, as compared to $3 million in the second quarter of last year. The decrease was driven by a large AXP purchase -- AXP disposable purchase from our distributor in China last year, which was offset by increased domestic AXP disposable and BioArchive device revenue in the second quarter of this year.

謝謝你，克里斯。新聞稿和 10-Q 中提供了有關我們財務狀況的完整討論。因此，我將花點時間回顧截至 2023 年 6 月 30 日的季度的主要財務數據。該季度的淨收入為 230 萬美元，而去年第二季度的淨收入為 300 萬美元。這一下降是由於大量 AXP 採購（去年從我們在中國的經銷商處購買的 AXP 一次性產品）推動的，但今年第二季度國內 AXP 一次性產品和 BioArchive 設備收入的增加抵消了這一下降。

Selling, general, and administrative expenses were $1.8 million for the quarter ended June 30, 2023, as compared to $2 million for the same period last year. The decrease was driven by lower employee benefit and decreased legal expenses in the second quarter of this year.

截至 2023 年 6 月 30 日的季度，銷售、一般及管理費用為 180 萬美元，而去年同期為 200 萬美元。這一下降是由於今年第二季員工福利下降和法律費用減少所致。

For the quarter ended June 30, 2023, the company recorded a comprehensive loss of $2.3 million or $0.91 per share based on approximately 2.5 million shares outstanding. This compares to a comprehensive loss of $2.7 million or $8.98 per share based on approximately 300,000 shares outstanding for the quarter ended June 30, 2022.

截至 2023 年 6 月 30 日的季度，該公司錄得綜合虧損 230 萬美元，即每股 0.91 美元，基於約 250 萬股流通股計算。相比之下，根據截至 2022 年 6 月 30 日的季度約 30 萬股已發行股票計算，綜合虧損為 270 萬美元或每股 8.98 美元。

At June 30, 2023, the company had cash and cash equivalents totaling $4.5 million compared with cash and cash equivalents of $4.2 million at December 31, 2022.

截至2023年6月30日，該公司的現金和現金等價物總額為450萬美元，而截至2022年12月31日的現金和現金等價物為420萬美元。

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

我們準備好的演講到此結束。現在我們想開始回答您的問題。操作員？

(Operator Instructions) Sean Lee, H.C. Wainwright.

（操作員說明）Sean Lee, H.C.溫賴特。

Good afternoon, Chris and Jeff, and thank you for taking my questions. My first question is on the GMP facility. So what remains to be done before they would be open for business, should we say, and be ready to have the first customers?

克里斯和傑夫，下午好，謝謝你們回答我的問題。我的第一個問題是關於 GMP 設施的。那麼，在他們開業之前還需要做什麼，我們應該說，並準備好迎接第一批客戶嗎？

Hi, Sean. Thanks for the question. So we have completed a majority of the infrastructure buildout and what's remaining is just to have the facilities certified by -- for ISO. And we are really in the last step -- last few steps. So we are actually very actively having customers pouring the facilities and having ongoing discussions with customers. It (multiple speakers) be opening state.

嗨，肖恩。謝謝你的提問。因此，我們已經完成了大部分基礎設施建設，剩下的就是讓設施獲得 ISO 認證。我們確實處於最後一步——最後幾步。因此，我們實際上非常積極地讓客戶澆築設施，並與客戶進行持續的討論。它（多個揚聲器）處於開啟狀態。

Okay. Do you have any potential leads on customers so far? And when do you estimate we can see the first one move in?

好的。到目前為止，您有任何潛在的客戶線索嗎？你估計我們什麼時候可以看到第一批搬進來？

Yeah, we are actively discussing with various different customer in the cell gene therapy and also in other life science fields that require GMP facility. So we may have customers moving as early as towards the end of the third quarter or very early fourth quarter. So we definitely see the growth of interest.

是的，我們正在與各種不同的客戶積極討論細胞基因療法以及其他需要 GMP 設施的生命科學領域。因此，我們可能會有客戶最早在第三季末或第四季初就開始行動。所以我們一定會看到興趣的增長。

Great. For these facilities, you mentioned they're used for cell therapies. In particular, are there specific types of cell therapies they will be well suited for?

偉大的。對於這些設施，您提到它們用於細胞療法。特別是，是否有特定類型的細胞療法非常適合它們？

Yes, this entire facility is highly specific and very specifically designed for cell and gene therapies because traditionally, for pharmaceutical industry and the cleanrooms tend to be large and allows big equipment to be put in to produce batches of drug. And each batch can be thousands of a patient.

是的，整個設施是高度特定的，並且是專門為細胞和基因治療而設計的，因為傳統上，對於製藥行業來說，潔淨室往往很大，並且允許放入大型設備來生產批量藥物。每一批可能有數千名患者。

Actually, each batch could be millions of a patient, and that's the historic way of producing drugs with cell and gene therapy. And that change the practice entirely because cell and gene therapy are very personalized and very individual.

實際上，每批可能涉及數百萬患者，這是利用細胞和基因療法生產藥物的歷史性方法。這完全改變了實踐，因為細胞和基因治療是非常個人化和個人化的。

So each drug is specifically produced for that particular patient. So you can see this as one drug, one patient. So the facility is designed into small GMP unit, almost like a beehive and that allow individual drugs -- individual personalized cell gene therapy can be produced in each unit. And you can produce as many batch as it allows and allow the quick turnover for each individual item medicine. So this facility is particularly designed for that purpose, and there are such a shortage of facility design for cell gene therapy at this moment.

因此，每種藥物都是專門為特定患者生產的。所以你可以將其視為一種藥物、一名患者。因此，該設施被設計成小型 GMP 單元，幾乎像一個蜂箱，並且允許在每個單元中生產單獨的藥物——單獨的個人化細胞基因療法。您可以生產盡可能多的批次，並允許每個藥品的快速週轉。所以這個設施是專門為此目的而設計的，而目前細胞基因治療的設施設計非常缺乏。

Thanks for that, and that's very helpful. My last question is on the potential revenues we can see from this [30]. What are -- what's the average revenue we can expect to see from each one of these suites? And what are your key costs for maintaining this?

謝謝你，這非常有幫助。我的最後一個問題是關於我們可以從中看到的潛在收入[30]。我們可以期望從這些套件中的每一款中看到的平均收入是多少？維持這一點的主要成本是多少？

So currently, we run 12 GMP unit, and each unit average 500 square feet size. For that 500 square feet that the average market cost, if it's available -- mostly are not available because of the big demand, and the average cost per 500 square feet GMP suite is about $75,000 to $150,000 per month. So basically, we have 12 GMP unit on hand.

目前，我們經營 12 個 GMP 單元，每個單元平均面積為 500 平方英尺。對於這 500 平方英尺的平均市場成本，如果可用的話，大多數由於需求量大而無法使用，每 500 平方英尺 GMP 套件的平均成本約為每月 75,000 至 150,000 美元。所以基本上，我們手邊有 12 個 GMP 裝置。

Sean, I mean, on an annualized basis, I mean, we're looking at roughly $1 million per suite, and the cost per suite are fairly minimal to us because most of the expenses -- the companies are coming in and renting the room, I mean, so realistically, we're looking at a pretty small number probably $50,000 to $100,000 per room on an annualized basis and expenses for us.

肖恩，我的意思是，按年計算，我的意思是，我們每間套房的成本約為100 萬美元，每間套房的成本對我們來說相當低，因為大部分費用- 公司都進來並租用房間，我的意思是，實際上，我們所考慮的數字很小，按年化計算和我們的費用，每間客房可能為 50,000 至 100,000 美元。

Yeah. And that's very helpful. Thanks to Chris, and thanks, Jeff. That's all I have.

是的。這非常有幫助。感謝克里斯，也感謝傑夫。這就是我的全部。

Thanks, Sean.

謝謝，肖恩。

This concludes our question-and-answer session. I would like to turn the conference back over to management for closing remark.

我們的問答環節到此結束。我想將會議轉回管理層致閉幕詞。

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

謝謝你，接線生。我們期待在 2023 年第三季電話會議上向您通報我們的最新進展，並感謝今天參加會議的所有人以及對 ThermoGenesis Holdings 的興趣。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。