ThermoGenesis Holdings, Inc.

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, 2022. As a reminder, all participants will be in listen-only 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 one on your phone. If you wish to withdraw your question, please press star, then two. If you should need assistance during the conference call, please signal the operator by pressing star, then zero. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Paula Schwartz of RX Communications. Please go ahead.

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, August 11, 2022. 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. Please go ahead.

Thank you, Paula. And thank you to everyone for joining the call this afternoon. We appreciate you taking time to listen in. Although it was a very quiet period on the news front during the second quarter, we continue to progress our plans to become an integrated CDMO for the cell gene therapy market. As most of you know, for over 35 years, Thermogenesis has pioneered the development and manufacture of a series of innovative automated technologies and products specifically for the cell banking and cell therapy industry. For many years, Thermogenesis has been the provider of choice for automated cell processing and automated smart cryogenic storage technologies for some of the world's most important public and private cell banks. Our bar archive cryo storage system has warehoused close to 90% of all U.S. FDA BLA-approved clinical-grade cold blood units, or CBUs, and our AXP system has processed well over a million samples worldwide by approximately 140 institutes across the world. Over the last few years, our team has continued to focus on what it does best, successfully developing additional FDA-approved cell processing medical devices for large-scale cell manufacturing for cell therapies. The intellectual property we have accumulated over our history is invariable and we are excited about the future. Driving our forward-looking strategy in large part is the continued growth of the industry focused on the potential for personalized cell and gene therapy. Since 2017, six autologous CAR-T therapeutics have been approved by the FDA, while CAR-T were initially approved for the last line of defense. More recently, there have been CAR-T trials that have shown that such therapies can outperform second line of standard 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. The potential of both cell gene therapies is enormous, and as we speak, there are more than 350 U.S. companies alone working in the cell therapy arena. And more than 1,000 pipeline assets are in clinical development globally, targeting a range of blood and solid tumors. With all these activities, the industry faces a daunting issue of drug manufacturing. Drug manufacturing is the largest component of the cost of CAR-T cell therapies, with list price ranging from $373,000 to $475,000 depending on the specific drug and indication. Manufacturing costs for each dose of CAR-T therapeutics currently exceeds $100,000, 79% of which is directly related to labor and the GMP facility costs. Therefore, the significant need for CGMP manufacturing at a reasonable cost for these extremely complex personalized therapies is crucial. Yet, while clinical trials for CAR-T and other next-generation cell gene therapeutics have continued, the industry continues to grapple with the serious capacity limits and high manufacturer costs. In fact, today, over 70% of the cell gene therapy developers outsource their manufacturing needs, while only 5% to 10% of the required capacity is expected to exist for the next 10 years. The volume of demand coupled with the technical complications has resulted in tremendous backlog. for these at the research, clinical or commercial stage. Moving away from manual process will be the key to facilitating fast timelines and getting these life-saving drugs from bench to bedside, creating an important window of opportunity for thermogenesis. All that said, During the second quarter, we took additional steps towards the launch of our TG biosynthesis, a contract cell manufacturing service division. The aim of the new division is to address the growing need for CDMO services by providing high-quality development and manufacture capabilities, cell tissue processing development, quality systems, regulatory compliance, and other cell manufacture solutions for clients with therapeutic candidates in various different stages of development. Strong intellectual properties, cutting-edge technology and expertise, and when build out the state-of-the-art manufacture capabilities, we will help address the ever-evolving manufacturing needs of organizations in the cell gene therapy field. We expect to capitalize on the inefficiency of the industry to become a leading CDMO cell manufacturing service provider. With that in mind, we began building out the approximately 35,000 square foot of laboratory and office space to create a state of art CGMP compliant facility with 12 CGMP clean room suites. This new space will go a long way to support the industry manufacturing requirements and will allow us to fully utilize our proprietary technologies, including the Cartier Express platform, which has shown the ability to reduce cell processing time by 75% and to potentially cut manufacturing costs by 50%. and which is to more efficiently and cost-effectively to produce cell gene therapy drug candidates for the industry. And with that, let me turn the call over to Jeff to share the key financial results for the second quarter. Jeff?

Thank you, Chris. Net revenues increased to $3 million for the quarter ended June 30, 2022, up 38% from Q2 of last year and 15% from last quarter. The increase was driven by AXP disposable revenue with increased orders from both domestic and international customers. Gross profit for the quarter ended June 30, 2022, was $900,000, or 31% of net revenue. Our gross profit percentage for this quarter was lower than normal, primarily due to one-time charges for inventory reserves and higher pricing from our contract manufacturer. We've implemented steps to decrease our costs going forward and expect to have our margins return to normal levels by the end of the year. Selling general and administrative expenses were $2 million for the quarter ended June 30, 2022, as compared to $3.5 million for the quarter ended June 30, 2021. The decrease was driven by stock compensation expense, which declined by approximately $1.9 million due to accelerated expense for stock options voluntarily surrendered in the second quarter of last year. Research and development expenses were $400,000 for the three months ended June 30, 2022, as compared to $600,000 for the three months ended June 30, 2021. The decrease was driven by lower personnel and project expenses. As the quarter ended June 30, 2022, the company reported a net loss attributable to common stockholders of $2.7 million, or 20 cents per share, based on approximately 13.5 million weighted average shares outstanding. This compares to a net loss of $4.5 million, or 38 cents per share, based on approximately 11.9 million weighted Average share is outstanding for the quarter end of June 30, 2021. June 30, 2022, the company had cash and cash equivalents totaling $4 million, compared with $7.8 million at December 31, 2021. Working capital is $1.8 million at June 30, 2022. That's compared to $8.6 million at December 31, 2021. This concludes our prepared remarks. Now we'd like to open the call to your questions. Operator?

Thank you. We will now begin the question and answer session. To ask a question, please press star then one on your touchtone phone. If you are using a speakerphone, please pick up your hands up before pressing the key. To withdraw from the question queue, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Sean Lee with HC Lainwright. Please go ahead.

Good afternoon, Chris and Jeff, and thanks for taking my questions. My first question is on the cord blood banking business. I know that during the pandemic, that side of the business suffered quite a bit as there's a global slowdown in the industry. I was wondering whether there are still any lingering effects or have the business returned to a pre-pandemic levels?

So I will jump on this first and then I will let Jeff to share some of the numbers. So overall, with all the entire industry gradually returned to its normal, so we do see recovery for this industry. So that's a good sign. And we do see an increase in some of our consumables orders in the second quarter. Jeff, can you share further on this?

Yeah, we're seeing revenues come back up to a closer pre-pandemic levels during 2022. If you just look at year over year to date, they're up significantly. Our AHP revenue for the six months into June 31st, 2022 is $3.7 million. as compared to just 1.1 million, or pardon me, 1.4 million for the six months ended June 30th, 2021. So, certainly, we're seeing a significant increase, and we are seeing the revenues come back to closer to where they were prior to the pandemic.

Fantastic. That's very helpful. My next question is on the CDMO businesses. So what remains to be done on the build out of the manufacturing facility, what's the expected timeline for that?

So with that, we are targeting towards the end of the year or first of the first quarter of the next year. So everything is on track with our timeline and We are preparing not only the infrastructure but also many of the internal developments of different SOPs and different processes. Overall, we were on track with the development of this service. This service remains to be in high demand.

I see. I see. And just to follow up on that, in terms of the customers that you look to target, is it just industry or are you looking for industry plus academia? And what about in terms of geography? Is it just going to be U.S. customers or international ones as well?

Thanks. So let me divide that into two different categories. One is based on their size. Because for cell gene therapy, the manufacturer cost is high and also the GMP manufacturer, the infrastructure. So many of the small to medium-sized companies cannot afford building their own infrastructure. And they account for a large percentage of the total developers in the industry. So it's natural that for them they will outsource their manufacturer capability as their requirement. So that's why 70% of the developer outsource their cell manufacturing needs. The second way to looking at the pie is geographic location of the customers. So as we know that about one-third of the cell gene therapy were developed domestically in the States. And there are more than two-thirds actually were developed outside the States. So many of the developers are looking to be able to launch the product eventually in the U.S. market, which requires them to carry out manufacturing and clinical trials within the states. So there are, that said, there are two-thirds of global customers coming to the U.S. to use contract manufacturing services.

I see. Thanks. That makes it more clear. That's all the questions I have.

Oh, thanks. Thanks, Sean.

This concludes our question and answer session. I would like to turn the call back over to management for any closing remarks.

Thank you, operator. We look forward to updating you on our progress during our third quarter 2022 call. And thank you to everyone who participated today and for your interest in thermogenesis holdings.

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