ThermoGenesis Holdings, Inc. (NASDAQ:THMO) Q4 2022 Earnings Call Transcript

ThermoGenesis Holdings, Inc. (NASDAQ:THMO) Q4 2022 Earnings Call Transcript March 31, 2023

Operator: Good day, and welcome to the ThermoGenesis Holdings Conference Call Webcast to review Financial and Operating Results for the Year Ended December 31, 2022. As a reminder, this conference call is being recorded. I would now like to turn conference 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, 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. 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, excuse me. Please go ahead, Chris.

Chris Xu: Thank you, Paula, and thank you to everyone for joining the call this afternoon. We appreciate you taking the time to . 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. 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.

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 , and manage overall risks. To that end, we recently announced the roll out of ReadyStart cGMP suites available for by early-stage life science and cell gene therapy companies expect it to be available to customers in the second and third quarter of this year. Before I 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.

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. 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 full potential for personalized cell and gene therapy.

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. 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. And we now have more than one solid pipeline asset in clinical development globally, targeting a variety of blood and solid tumors. And fortunately, the surge in clinical activity has not been matched by an increase in production capacity.

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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 10 or 12 to 18 months backlog in commercial manufacturing. This will only be exacerbated by accelerated approvals in the coming days. 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. 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.

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. The need for cGMP manufacturing of this extremely complex 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, system, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various stage of development.

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. 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 cGMP cleanroom suites to support the industry’s manufacturing requirements. These ReadyStart cGMP Suite will be available for this 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.

Further, the suites will eliminate a tremendous resource burden and greatly accelerate the development cycle by allowing rather than companies to focus on core science. Our all-encompassing ReadyStart cGMP Suite will provide a flexible option companies to achieve their anticipated milestones faster and more efficiently. 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. 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. And with that, let me turn the call over to Jeff to share some of the key financial result for the year. Jeff?

Jeff Cauble: 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. 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. A decrease was also driven by reduced stock compensation expense. 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 of weighted average shares outstanding. This compares to 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. 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. This concludes our prepared remarks. So now we’d like to open the call for your questions. Operator?

Operator: Sean Lee, H.C. Wainwright.

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Q&A Session

Sean Lee : Good afternoon, guys, and thanks for taking my questions. It’s great to hear that the CBMO business is ready to get started 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 how they’re different tiers based on whether they use their own manufacturing technology or use the cell platform?

Chris Xu : Hi, Sean, this is Chris, and thank you for the question. And just to address the first part of the crushing with regards to the models that we are running. So, ThermoGenesis eventually is running at the CDMO as third-party manufacturer, which means we are manufacturing the final products for the developers. At this moment, which we still consider a transition period moving from a medical device to the CDMO service, we offer some 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 moves for the developers if they want to have their own scaled-up process just by using our cGMP facilities.

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 A, on 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?

Sean Lee : 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 need to offer?

Chris Xu : 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 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.

Sean Lee : I see. So, the other stuff will be on top of this .

Chris Xu : Yes.

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

Chris Xu : At this moment, we are still trying to find the right number. Certainly, it 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 trying to get a sense of the range. I guess this will be in par with the industry average.

Sean Lee : 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 as well?

Chris Xu : 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 a marketing, advertising such as the nature, such as Science magazine. But we’re also reaching out through standard digital media and other facilitator professional broker in this space. So, we are taking multiple approach to reach out to our customer.