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spk04: Good day and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the year ended December 31, 2022. As a reminder, all participants will be in the Sonomi mode. There will be an opportunity to ask questions at the end of today's presentation. If you would like to ask a question, please press star then 1 on your phone. If you wish to withdraw your question, please press star then 2. If you should need assistance during the conference call, please signal an operator by pressing star, then zero. As a reminder, this conference call is being recorded. I now would like to turn the conference over to our host, Paula Schwartz of RX Communications. Please go ahead.
spk01: 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 Hsu, Chief Executive Officer, and Jeff Cobble, Chief Financial Officer. I'd now like to turn the call over to Chris. Excuse me. Please go ahead, Chris.
spk03: Thank you, Paula, and thank you to everyone for joining the course 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 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 million private placement transaction. These financings 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-T Express 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 clinic 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. To that end, we recently announced the rollout of ready-start CGMP suites available for these 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. 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. 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 bio archive file storage system has warehoused close to 90% of all U.S. FDA VLA-approved pinnacle-grade cold blood units. And our ASP 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 potential for personalized cell and gene therapy. Since 2017, six autologous CAR-T therapies have 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 reports show that the industry anticipates additional FDA approvals with as many as 10 to 20 new therapies each year starting in 2025. As the demands 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. 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 therapy companies outsource their manufacturing needs, only a fraction of the 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. 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 demand 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 drops from bench to bedside. At the same time, there are the main critical and growing needs for manufacturing of these compact 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 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 CDMP manufacturing of these 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 systems, 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 Tati Express platform, combined with our existing in-house expertise to provide variable 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 plus seven CGMP clean room suites to support the industry's manufacturing requirements. These ReadyStart CGMP suite will be available for these by early stage life science and therapy companies. Importantly, the ReadyStart suite will meet the highest scientific quality and regulatory requirements and are ideal for early stage companies looking to jumpstart 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 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. 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 own science while Thermogenesis will manage the regulatory and quality compliance associated with running a GMP facility. The ReadyStar 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 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 results for the year. Jeff?
spk02: 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 transitioned 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 end of December 31st, 2022, as compared to $2.2 million for 2021. The decrease was also driven by reduced stock compensation expense. For the year end of December 31st, 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 end of 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?
spk04: Yes, thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To answer your question, please press star, then 2. At this time, we will pause momentarily to assemble the roster. And the first question comes from Sean Lee with HC Wainwright.
spk05: Good afternoon, guys, and thanks for taking my questions. It's great to hear that the CDMO business is ready to get started running. I'm 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 effects platform?
spk03: Hi, Sean. This is Chris. And thank you for the question. And just to address your 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. At this moment, which is we still consider a transition period, moving from a medical device to the CDMO services, we offer those extra CGMP rooms as a lease, which is one of the options for the drug developers, because certainly we 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 CDMP 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 facilitation of their FDA regulatory findings. So we can be a, from one end, a simple solution by providing the GMP to them just by operating as a facilitator, or to a full service which providing a comprehensive white lab service early-stage or mid-stage companies. Does that help? Does that help?
spk05: Yeah, that was very helpful. Thank you. In that case, I think in the prepared remarks you mentioned, if fully leased, we can expect revenues of between 10 and 16 million from these facilities. Is that the range coming from the differences in the services that you would offer?
spk03: That's the 10 to 15 million is just based on the lease option. Basically we provide, assuming this is fully leased out, we are providing facilitation just maintaining the regulatory compliance and quality compliance for the GMP facility. So it doesn't include any of the higher, more comprehensive service models that we intend to provide.
spk05: I see, I see. So the other stuff will be on top of this range then? Yes. Assuming that the facility is fully leased out, what sort of gross margins can we expect from these services?
spk03: At this moment, we are still trying to finalize the number. Certainly, it will be in par with the industry average or a little higher. So at this moment, we cannot give the forecast yet, but we are working around the clock trying to get a sense of the range. I guess it will be in part with the industry average.
spk05: Okay, that's fine. And my final question is, what sort of outreach activities are you doing to help attract companies to these new facilities and get them to start using perhaps your own self-executives as well? Sure.
spk03: So we are taking multiple strategies in reaching out to our customers, which includes some of the very traditional reaching out, such as marketing and advertising in professional magazines, such as science magazines. But we are also reaching out through standards standard digital media and other facilitators in terms of a professional broker in this space. So we are taking multiple approaches to reach out to our customers.
spk05: Great. That's all the questions I have, and thanks again for taking my questions.
spk03: You're welcome.
spk04: Thank you. And this concludes our question and answer session. I would like to turn the conference over to Dr. Hsu for any closing comments.
spk03: 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.
spk04: Thank you. The conference has now concluded. Thank you for attending today's presentation.
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