Thermogenesis Holdings Inc (THMO) 2023 Q1 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 first quarter ended March 31, 2023. (Operator Instructions) As a reminder, this conference call is being recorded.

美好的一天，歡迎參加 ThermoGenesis Holdings 電話會議和網絡直播，回顧截至 2023 年 3 月 31 日的第一季度財務和經營業績。（操作員說明）提醒一下，本次電話會議正在錄製中。

I'd now like to turn the 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, May 15, 2023. And 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.

今天提供的信息是時效性的，並且僅在 2023 年 5 月 15 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. I'd now like to turn the call over to Chris. Please go ahead, Chris.

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。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 to take the time to listening. During the first quarter, we are making progress towards executing our plans to transform from a medical device company to an integrated contract development and manufacturing organization, or CDMO for the cell and gene therapy markets.

謝謝 Paula，也感謝大家今天下午加入電話會議。我們感謝您花時間聆聽。在第一季度，我們在執行我們的計劃方面取得了進展，從一家醫療器械公司轉型為一家綜合合同開發和製造組織，即細胞和基因治療市場的 CDMO。

In March 2023, we closed a $3 million private placement, which will help support the planned launch of our CDMO business. The goal is to leverage our unique and proprietary automated and semi-automated cell processing technologies, including the CAR-TXpress platform to manufacture future cell gene therapies cheaper and more efficiently.

2023 年 3 月，我們完成了 300 萬美元的私募，這將有助於支持我們計劃推出的 CDMO 業務。目標是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，以更便宜、更高效的方式製造未來的細胞基因療法。

To that end, we have made significant headway building out a 12 units ReadyStart cGMP Suites at our 35,500 square foot facility in Sacramento. These class-7 cleanrooms are designed to meet the highest scientific quality and regulatory requirements that would be ideal for the early-stage companies and institutions developing next generation of cancer medicines, such as CAR-T cell therapies and to accelerate drug candidates into clinic, quicker and safer.

為此，我們在薩克拉門托 35,500 平方英尺的設施中建造了 12 個單位的 ReadyStart cGMP 套房，取得了重大進展。這些 7 級潔淨室旨在滿足最高的科學質量和監管要求，非常適合早期公司和機構開發下一代癌症藥物，例如 CAR-T 細胞療法，並加速候選藥物進入臨床，更快更安全。

Our goal is to establish solutions for customers in order to streamline the supply chain, increase manufacturing predictability, and manage overall risk. We have begun to market this turnkey solution to early-stage life science cell gene therapy companies, who are looking to jump-start their development efforts and scale up in the same facility. We expect the ReadyStart cGMP Suites to be available for these two customers in the second or third quarter of this year.

我們的目標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。我們已經開始向早期生命科學細胞基因治療公司推銷這種交鑰匙解決方案，這些公司希望在同一設施中快速啟動開發工作並擴大規模。我們預計 ReadyStart cGMP Suites 將在今年第二或第三季度為這兩個客戶提供。

As you may know, for over 35 years, ThermoGenesis has pioneered the development and manufacturing of a series of innovative automated technologies and products, specifically for the cell banking and cell therapy industry. In fact, ThermoGenesis has been the leading provider of choice for automated cell processing and automated smart cloud storage technologies for some of the world's most important public and private cell banks. Our BioArchive smart file storage systems has warehoused close to 90% of all US FDA BLA approved clinical-grade cord blood units or CBUs, and our AXP system has been used to process well over a million samples from well over 100 institutes globally.

如您所知，35 年來，ThermoGenesis 率先開發和製造了一系列創新的自動化技術和產品，專門用於細胞庫和細胞治療行業。事實上，ThermoGenesis 一直是世界上一些最重要的公共和私人細胞庫的自動化細胞處理和自動化智能雲存儲技術的首選供應商。我們的 BioArchive 智能文件存儲系統存儲了近 90% 的所有美國 FDA BLA 批准的臨床級臍帶血單位或 CBU，我們的 AXP 系統已用於處理來自全球 100 多家機構的超過一百萬個樣本。

In addition to our manufacturing know-how in cell gene therapies, the intellectual properties that we have amassed over the years are invaluable. Driving our shift to a CDMO in large part is the continued growth of the industry, focusing on the potentials for personalized cell and gene therapies. Since 2017, six autologous CAR-T cell therapies have been approved by the FDA. CAR-T cells piece were approved as the last line of defense for those patients who did not respond to other therapeutic options.

除了我們在細胞基因療法方面的製造專業知識外，我們多年來積累的知識產權也是無價之寶。在很大程度上推動我們轉向 CDMO 的是該行業的持續發展，重點關注個性化細胞和基因療法的潛力。自 2017 年以來，已有 6 種自體 CAR-T 細胞療法獲得 FDA 批准。 CAR-T 細胞片被批准作為那些對其他治療方案沒有反應的患者的最後一道防線。

More recently, there have been several CAR-T trials that have shown that such therapies can outperform second lines or standard of care options, indicating that the applications for CAR-T cell therapy may expand that in the future. Recent report shows that the industry anticipate additional FDA approvals with as many as 10 to 20 new cell therapies potentially being approved for commercialization annually, starting in 2025.

最近，有幾項 CAR-T 試驗表明，此類療法可以優於二線或標準護理選項，這表明 CAR-T 細胞療法的應用可能會在未來擴大。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 種新細胞療法可能獲得 FDA 批准用於商業化。

With more cell therapies such as CAR-T cell therapies received FDA approval, the demand for manufacturing of these life-saving therapy continues to grow. As we speak, there are more than 350 US companies alone working in the cell therapy arena, and more than 1,000 pipeline assets in clinical development globally, targeting a range of blood and solid tumors. While a majority of these innovative research are driven by small to medium-sized biotech companies and medical research centers, the demand for third-party manufacturer continues to grow.

隨著越來越多的細胞療法（例如 CAR-T 細胞療法）獲得 FDA 批准，對製造這些挽救生命的療法的需求持續增長。就在我們說話的時候，僅美國就有 350 多家公司從事細胞治療領域的工作，全球有 1,000 多項臨床開發管道資產，目標是一系列血液和實體瘤。雖然這些創新研究大部分是由中小型生物技術公司和醫學研究中心推動的，但對第三方製造商的需求仍在持續增長。

Each of our lower income passing registered cGMP suites will provide a flexible option, enabling small to medium-sized companies to achieve their anticipated milestones faster and more efficiently. Additionally, our team's strong expertise in regulatory affairs and product commercialization will help accelerate the development of our customers' products, allowing them to focus on their science, while ThermoGenesis will manage the regulatory and quality compliance associated with running a GMP facility.

我們每個通過註冊的 cGMP 套件的低收入都將提供一個靈活的選擇，使中小型公司能夠更快、更有效地實現其預期的里程碑。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快客戶產品的開發，使他們能夠專注於他們的科學，而 ThermoGenesis 將管理與運行 GMP 設施相關的法規和質量合規性。

With ThermoGenesis' strong intellectual property positioning, cutting edge technology, and manufacturing service expertise, our new facility will have the ability to address the increased demand for cell gene therapy manufacture capabilities. We will remain focused on launching the CDMO serviced and ReadyStart cGMP units to customers in the cell gene therapy field in the next few months.

憑藉 ThermoGenesis 強大的知識產權定位、尖端技術和製造服務專業知識，我們的新設施將能夠滿足對細胞基因療法製造能力不斷增長的需求。在接下來的幾個月裡，我們將繼續專注於向細胞基因治療領域的客戶推出 CDMO 服務和 ReadyStart cGMP 單位。

And with that, let me turn the call over to Jeff to share the key financial results for the first quarter. Jeff?

就此，讓我把電話轉給傑夫，分享第一季度的主要財務業績。傑夫？

Thank you, Chris. A full discussion of our financials is available in our 10-Q. So, I will just take a moment to review key financials for the quarter ended March 31, 2023.

謝謝你，克里斯。我們的 10-Q 中提供了對我們財務狀況的完整討論。因此，我將花點時間回顧一下截至 2023 年 3 月 31 日的季度的主要財務數據。

Net revenues for the quarter were in line with the first quarter of last year at $2.6 million. Product mix was slightly different with higher domestic AXP disposable sales and BioArchive service revenue in the current year.

本季度淨收入為 260 萬美元，與去年第一季度持平。產品組合略有不同，本年度國內 AXP 一次性銷售額和 BioArchive 服務收入較高。

Gross profit for the quarter was $1.1 million or 43% of net revenue compared to $900,000 or 35% of net revenues for the first quarter of 2022. The increase was driven by lower inventory reserves in the current year. Selling, general and administrative expenses were $1.8 million for this quarter as compared to $1.7 for the first quarter last year. The increase was driven by rent and operating expenses for our new CDMO facility offset by lower personnel expenses.

本季度毛利潤為 110 萬美元，占淨收入的 43%，而 2022 年第一季度為 900,000 美元，占淨收入的 35%。這一增長是由於本年度庫存儲備減少所致。本季度的銷售、一般和管理費用為 180 萬美元，而去年第一季度為 1.7 美元。增加的原因是我們新的 CDMO 設施的租金和運營費用被較低的人員費用所抵消。

Interest expense was $3.9 million for the quarter, driven by non-cash amortization expenses related to the company's convertible notes. For the quarter, the company reported a comprehensive loss of $5 million or $4.07 per share based on approximately 1.3 million weighted average shares outstanding. The company ended the quarter with cash and cash equivalents of $5.9 million compared with cash and cash equivalents of $4.2 million at December 31, 2022. This concludes our prepared remarks. And now we'd like to open the call to your questions. Operator?

本季度的利息支出為 390 萬美元，主要受與公司可轉換票據相關的非現金攤銷支出的推動。本季度，公司報告綜合虧損 500 萬美元或每股 4.07 美元，基於約 130 萬股加權平均流通股。公司本季度末的現金和現金等價物為 590 萬美元，而 2022 年 12 月 31 日的現金和現金等價物為 420 萬美元。我們準備好的評論到此結束。現在我們想打開您的問題的電話。操作員？

(Operator Instructions)

（操作員說明）

Sean Lee, HC Wainwright.

肖恩·李，HC 溫賴特。

Good afternoon, guys, and thanks for taking my question. (technical difficulty) I was wondering if you could provide some more color on the CDMO facility. Now that it's almost up and running, how does your pricing compare to similar facilities on West Coast?

下午好，伙計們，謝謝你提出我的問題。 （技術難度）我想知道你是否可以在 CDMO 設施上提供更多顏色。現在它即將啟動並運行，與西海岸的類似設施相比，你們的定價如何？

Thanks, Sean. Thanks for the question. And currently the entire CDMO demand -- the demand for CDMO facilities are pretty high in the entire United States. And many of the facilities require up to 12 or even more -- 12 to 18 months waiting period. So, the average pricing for the industry also is quite significant. We are priced ourself comparable rate to what is offered in industry, with some of the initial promotion. But I think what we offer is a missing capacity that the industry currently is lacking.

謝謝，肖恩。謝謝你的問題。目前整個 CDMO 需求——整個美國對 CDMO 設施的需求相當高。許多設施需要長達 12 甚至更多——12 到 18 個月的等待期。因此，該行業的平均定價也相當重要。我們的定價與行業內提供的價格相當，並有一些初始促銷。但我認為我們提供的是該行業目前缺乏的缺失能力。

And these flexibility are very ideal for small to medium-sized company. And we have seen an influx of companies and visitors exploring these options. And our ads where were coming out this coming week, actually this week through Science Magazine. So I think even with a very comparable pricing to our competitors, it's really the missing capacity that we offer. So that's in high demand.

這些靈活性非常適合中小型公司。我們已經看到大量公司和訪客正在探索這些選項。我們的廣告將在下週發布，實際上是本週通過科學雜誌發布。因此，我認為即使與我們的競爭對手有非常可比的定價，這確實是我們提供的缺失容量。所以需求量很大。

That's good to hear. In terms of capacity, what -- how many doses are we talking about if all 12 of these rooms are being used?

聽起來還不錯。就容量而言，如果所有 12 個房間都被使用，我們在談論多少劑量？

We intend to use that through a mixture of developing our own manufacturing service and meeting out extra space to outsiders. If we use the entire manufacture suite for ourselves, we are talking about probably close to 10,000 dose of GMP core 80 clinical ready cell gene therapy a year.

我們打算通過開發我們自己的製造服務和為外界提供額外空間來利用它。如果我們自己使用整個製造套件，我們談論的是每年可能接近 10,000 劑 GMP 核心 80 臨床就緒細胞基因療法。

Okay. That's good enough. My last question is as you mentioned, I've seen some of your marketing efforts already underway as well. I was wondering whether you've had some earlier comments or questions coming from potential customers on the facility or how to improve it?

好的。這已經足夠了。正如你提到的，我的最後一個問題是，我已經看到你的一些營銷工作也已經在進行中。我想知道您之前是否收到過潛在客戶對該設施的一些評論或問題，或者如何改進它？

Actually, the feedback are very positive in a ways that, in our facility we have the the mixture of high-end ReadyStart cGMP Suites, and also the common lab that developed can be used to develop the cell therapies, which is more of a generalized wet lab.

實際上，反饋在某種程度上是非常積極的，在我們的設施中，我們擁有高端 ReadyStart cGMP 套件的混合物，而且開發的通用實驗室可用於開發細胞療法，這更像是一個通用的濕實驗室。

So having capacity of both in the same facility is really ideal for the entire industry, for many of the companies. We are actually, as we are aware of, probably the only one in the region or even in the nation that was providing such a combination. So, people seems to do like it.

因此，對於整個行業和許多公司來說，在同一個設施中同時擁有這兩種能力是非常理想的。事實上，正如我們所知，我們可能是該地區甚至全國唯一提供這種組合的公司。所以，人們似乎確實喜歡它。

That's going to hear. That's all the questions I have. Thanks, again.

那會聽到的。這就是我所有的問題。再次感謝。

Great. Thanks, Sean.

偉大的。謝謝，肖恩。

Thanks, Sean.

謝謝，肖恩。

This concludes our question and-answer session. I would like to turn the conference back over to Dr. Chris Xu for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給 Chris Xu 博士作閉幕詞。

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

謝謝你，運營商。我們期待在 2023 年第二季度的電話會議上向您通報我們的進展情況。感謝今天參加的每一個人，感謝你們對 ThermoGenesis Holdings 的關注。謝謝。

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。