ThermoGenesis Holdings, Inc. (NASDAQ:THMO) Q3 2023 Earnings Call Transcript

ThermoGenesis Holdings, Inc. (NASDAQ:THMO) Q3 2023 Earnings Call Transcript November 13, 2023

Operator: Good day. And welcome to the ThermoGenesis Holdings Conference Call and Webcast to Review Financial and Operating Results for the Third Quarter ended September 30, 2023. As a reminder, this call is being recorded today. I would now like to turn the conference call over to our host, Paula Schwartz of Rx Communications. Please go ahead.

Paula Schwartz: 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. The information presented today is time-sensitive and is accurate only as of the date of this call, November 13, 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. 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.

Dr. Chris Xu: Thank you, Paula, and thank you to everyone for joining the call today. We appreciate you taking the time to listen in. During the third quarter and subsequent period, we continued to make significant progress in executing our plan to transform from a medical device company to an integrated contract development and manufacturing organization or CDMO, for the cell gene therapy market. To that end, we completed and officially launched our 35,500 square feet cGMP clean room suite in Sacramento. cGMP stands for Current Good Manufacturing Practice. Our 12 ReadyStart cGMP clean room suites are designed to meet the highest scientific, quality and regulatory requirements for the cell gene therapy field and will be ideal for early- and mid-stage companies and institutions that are currently developing cell and gene therapies, and advanced therapy medicinal products or ATMPs. We provide this turnkey solution to early- and mid-stage life science and biopharmaceutical companies who look to jumpstart their R&D efforts and to scale up for clinical development quickly.

Our goal is to establish solutions for customers in order to streamline the supply chain, increase manufacturing predictability and manage overall risk while reducing overall costs. As most of you know, for over 35 years, ThermoGenesis has pioneered the development and manufacturing of a series of innovative automated technologies and products, especially for the cell-banking and cell therapy industry. The driving force for us to transition into a CDMO is largely due to the continuous growth on personalized cell and gene therapies. Since 2017, the FDA has approved six autologous CAR-T therapeutics, while CAR-Ts were initially authorized as the last result for patients who did not respond to other therapeutic treatments, recent CAR-T trials have demonstrated that these treatments can surpass second-line standard-of-care options, suggesting that the scope of the application for CAR-Ts may expand in the future.

According to recent reports, the industry anticipates further FDA approvals, potentially of 10 to 20 new cell gene therapies per year starting in 2025. At this very moment, there are over 350 U.S. companies operating in the field of cell therapy alone, with over 1,000 pipeline assets worldwide. The ongoing surge in research and development is enabled by the remarkable potential that exists in the current commercialized therapies. As thousands of preclinical and clinical trials are currently underway for innovative cell therapies, there is increasing need for dependable and quality CDMO cell manufacturing services. Our CDMO services will provide clients with high quality development and manufacturing capabilities, along with cell tissue — cell and tissue processing development, quality systems, regulatory compliance and other cell manufacturing solutions for the therapeutic candidates at different stages of development.

An engineer operating a 3D printing machine to create a organ or cell-based transplant for a autoimmune disease.

A crucial aspect of our plan is to leverage our proprietary, highly efficient, semi-automated CAR-T Express platform, which has already demonstrated the ability to significantly reduce processing time, improve cell recovery rates and potentially lower the manufacturing cost associated with the cell gene therapies by up to 50%. Additionally, our team’s strong expertise in regulatory affair and product commercialization will help accelerate the development of our customer’s products, allowing them to focus on their science, while ThermoGenesis will manage the regulatory and quality compliance associated with running a cGMP facility. Utilizing our extensive and comprehensive knowledge and experiences in the cell therapy field, we aim to offer clients the advantage of our broad expertise across the manufacturing of many different cell types.

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

Jeff Cauble: Thank you, Chris. A full discussion of our financials is available in the earnings release and 10-Q, so I’ll just take a moment to review the key financial information for the quarter ended September 30, 2023. Net revenues were $2.2 million for the quarter, up approximately $100,000 from the same period as last year. Current revenues continue to be driven by AXP disposable sales, which were up approximately $400,000 from the third quarter of last year. With the completion of our ReadyStart clean rooms in October, we will begin recording revenues from CDMOs — CDMO services in the fourth quarter. Gross profit for the third quarter was $400,000 or 18% of net revenue, in line with our gross profit from the same period in 2022.

The expectancy increases in our gross margin in 2024, as a higher percentage of our revenue is derived from CDMO services. Selling, general and administrative expenses were $1.7 million for the third quarter, as compared to $2 million for the same period last year. The decrease was driven by lower employee benefit and corporate expenses. Interest expense was $2.1 million for the third quarter, as compared to $1.4 million for the same period in 2022. The increase was driven primarily by non-cash amortization expense in the current year. For the quarter ended September 30, 2023, the company reported a comprehensive loss attributable to common stockholders of $3.6 million or $1.44 per share, based on approximately 2.5 million shares outstanding.

This compares to a comprehensive net loss of $3.2 million or $4.66 per share, based on approximately 700,000 shares outstanding for the quarter ended September 30, 2022. At September 30, 2023, the company had cash and cash equivalents totaling $4 million, compared with cash and cash equivalents totaling $4.2 million at December 31, 2022. This concludes our prepared remarks. So now we’d like to open the call for your questions. Operator?

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Q&A Session

Operator: [Operator Instructions] At this time, we will take our first question, which will come from Sean Lee with H.C. Wainwright. Please go ahead.

Sean Lee: Good afternoon, everyone, and thanks for taking my questions. My first question is on the response so far to the launch. I was wondering, how have you been marketing your CDMO services since its launch and what — how would you gauge the response so far from the market?

Dr. Chris Xu: Hi, Sean. Thanks for following up on our company. So we officially launched and had a ribbon-cutting event in October. And we have seen that have — that the client started to move in this. And there are certainly, as you may be aware, a nationwide shortage of CDMO facilities and services across the entire country. So there are an increasing number of biotech and pharmaceutical companies looking for not only just the CDMO service, but also facilities that have the full cGMP capability to help them develop and manufacture product candidates for clinical trials. So we certainly, with regards to how we market this, and the long-term goal is to use some of the new suites by ourselves by launching the service. But in the short-term, we are actually engaging a few different agents and brokers in the laboratory space in the life science area, where they see a clear shortage of such cGMP labs and they are really helping marketing our newly opened facility nationwide.

And on a financial end, we will probably — I will leave that to Jeff, but we will probably start to recording the revenue in the fourth quarter.

Jeff Cauble: Yeah. That’s correct. I mean, we do have several — we’re actively engaged with several customers right now on contracts that are in process. We have a couple that are finalized right now. So we do anticipate seeing some revenues this quarter, but as a lot of the companies are just moving in, I think, we’ll see the larger revenues begin to hit in 2024.

Sean Lee: That’s great to hear. Thank you for that. My next question is on the future direction. So you mentioned you have the suites ready. Would you be able to expand additional suites if deemed there’s enough demand for it and would these suites be able to be upgraded with the — how would these suites be able to be upgraded with the CAR-T Express system?

Dr. Chris Xu: Okay. So, currently we have 12 cGMP suites. And Jeff, just putting that into perspective, and I mean, for instance, UC Davis is a major research-oriented university has six GMP suites. And many of the academic centers have single-digit manufactured suites. So that puts us in pretty good shape, satisfying the need of the market. We do have extra space that we can expand to building more of such GMP suites, if needed. With regards to whether we can upgrade this to CAR-T, currently we design our cGMP in the highest quality and standards. These suites are ready to take on CAR-T manufacturing as yet. So in that regard, we really don’t have to upgrade them. With regards to future, to lease out some of the GMP suites is really just so that we can use this extra space for the time being.

The long-term goal is actually we leverage our proprietary manufacturing platform, as you know, the CAR-T Express platform, which significantly reduces the manufacturing cost by 50%. By providing a CDMO service ourselves, we can save our clients a lot more in terms of the manufacturing needs. So that’s the long-term goal. It’s not just to lease out those, but actually providing the drug manufacturing service for the cell gene therapy field.