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THMO Q2 2018 Earnings Call Transcript

Executives: Paula Schwartz - Rx Communications Chris Xu - Chief Executive Officer Joe Balagot - Senior Vice President of Corporate Development Jeff Cauble - Principal Accounting Officer

Operator: Good day everyone. And welcome to the Cesca Therapeutics Conference Call and Webcast to review Financial and Operating Results for the transition periods for six months ended December 31, 2017. As a reminder, all participants will be in a listen only mode. There will be an opportunity for you to ask questions at the end of today’s presentation [Operator Instructions]. This conference call is being recorded today. I would now like to introduce your host for today’s conference, 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 might 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 conference call, March, 22, 2018. If any portion of this call is being rebroadcast, retransmitted, or redistributed at a later date, Cesca will not be reviewing or updating this material. Participating in today's call are Dr. Chris Xu, Chief Executive Officer; Joe Balagot, Senior Vice President of Corporate Development: and Jeff Cauble, Principal Accounting Officer. And now, I would like to turn the call over to Chris. Please go ahead.

Chris Xu: Thank you, Paula. Good afternoon everyone, and thank you for joining us. I will start by providing a strategic and operational update. Then Joe will discuss rent corporate development activities and Jeff wrap up with a review of the financials. We will then take your questions. Since our last quarterly call, we have continued to make excellent progress, adapting our industrial leading center of processing technology through the aggressive growing field of CAR-T and other immune therapies. Our acquisition of SynGen last July was highly complementary to our own legacy product line. And together, we now offer one of the most comprehensive portfolios of cellular manufacturing and storage solution in the industry. Development of our innovative CAR-TXpress system is progressing rapidly. And we are moving towards introducing several kits, first to the research market for thereafter with our first commercial cellular processing solution. As a reminder, CAR-TXpress is a fully automated platform that enable CAR-T developers to manufacture high quality clinical grade CAR-T cells in a closed system at a robust scale. CAR-T cell based drugs are among the most advanced cancer therapies in the immuno-oncology field that target both hematopoietic cancers and solid tumors. CAR-T cell based immunotherapeutics have become the next pillar of cancer treatment, following surgery, radiation and chemotherapy. CAR-T cell based therapeutics use a patient’s own immune system to fight cancer cells. At the end of 2017, there were over 400 CAR-T related immune-oncology clinical trials registered globally on the National Institute of Health, clinicaltrial.gov Web site. However, these CAR-T cell-based therapeutics can cost $373,000 to $475,000 per dose. A complicated CAR-T cell processing and manufacturing process is the main driver of the high cost and also significantly limit the ability to manufacture these highly effective cell based targets -- cell based address at scale. The high drug cost and low capacity are significant barriers affecting the future application and affordability of these new immunotherapies. As more CAR-T therapeutics enter clinical trial, we firmly believe that factors like cost, capacity and consistency, will be the critical success factor for the entire field. Automation can be the key to these factors and we are working to adapt our technology through this exciting new field. As discussed, we have invested significant resource, developing and acquiring technology in the CAR-T automation field. With four new patents filed and two-patents awarded in the second half of the 2017, we introduced an all new CAR-TXpress platform at the CAR-TCR Summit in Boston last November. CAR-TXpress is a proprietary functionally-closed semi-automated system that can significantly reduce the processing time and increase efficiency for the CAR-T cellular manufacturing process. CAR-TXpress can also easily adapt to other gene therapies and stem cell therapies. We see numerous opportunities to collaborate with pharmaceutical companies, medical technology companies and academic institutes and distributors. I would like to turn the call over to Joe Balagot. Joe joined the company in November and brings to the team more than 20 years of investment banking and advisory experience. Joe has been working diligently to advance our discussions with potential partners. Joe will review the benefits of Cesca’s technology and the status of our products low up. Joe?

Joe Balagot: Thanks Chris. As a reminder, our CAR-TXpress Solution is based on our proprietary Buoyancy-activated cell sorting or BACS Technology. BACS employs microscopic bubbles to isolate a specific cell type from a complex mixture of cells such as blood. These micro-bubbles bind to antibodies on their surface, enabling them to bind specifically to a single desired target cell type. Through centrification, the target cells float to the top of the host liquid, while the non-target cells sink to the bottom. With this proprietary technology, CAR-TXpress eliminates the need for Ficoll and traditional magnetic bead-based isolation procedures, which frankly represent a dated and highly inefficient way of producing cell therapies, especially given a patient population for which time is a critical factor. In contrast, our BACS technology dramatically reduces processing time and increases efficiency, thereby also reducing the overall manufacturing cost. BACS technology is a key differentiator for our company. And during the second half of 2017, I'm pleased to note that we were granted two patents covering this novel method of cell separation. We currently have additional patents pending, including one that we filed just last week covering cell activation and transduction. This patent application modifies our proprietary CAR-TXpress workflow to enable yet additional manufacturing steps to be completed within a single cartridge, from initial preprocessing of blood or Leukopoiesis product through to T-cell activation and transduction. As a result, purification and activation of T-cells would be completed simultaneously. Thus, further simplifying the CAR-TXpress workflow and offering the potential for even greater efficiency and reduce manufacturing cost. This is just the latest example of how we continue to position Cesca at the cutting edge of cellular processing technologies. Digging a bit deeper into CAR-TXpress, the CAR-TXpress platform includes the following X series products. X-Lab for cell isolation is a semi-automated functionally closed Ficoll free system for the rapid isolation of different target cells from various sources, including blood samples, bone marrow aspirates and Leukopoiesis product. X-BACS for cell purification is a semi-automated functionally closed system that employs micro-bubbles to isolate the target cell through Buoyancy-activated cell sorting. These micro-bubbles bind to antibodies on their surface, enabling them to bind specifically to the desired target cell. Subsequent collection of the floating target cell coated with micro-bubbles provides a highly purified preparation of target cells with high recovery efficiency and cell viability. X-Wash for washing and reformulation is a semi-automated functionally closed system that separates, washes and volume reduces frozen cells or cell cultures to a programmable volume. And finally, BioArchive for cryogenic cellular product storage is an automated controlled rate liquid nitrogen freezer intended for the cryopreservation and single cassette-based storage of clinical samples. The BioArchive provides customers who need cryogenic cellular product storage with a solution that combines the individualized sample storage retrieval capacity with real-time chain of custody management. In addition to these products, during 2018, we plan to introduce several off-the-shelf kits for the research market. These include X-Mini, X-Maxi and X-Auto. And in 2019, we plan to release X-Clini, which will be Cesca’s first kit the commercial manufacture of clinical grade CAR-T cells compliant with GMP standards. Another key element of our growth strategy involves expanding beyond all off-the-shelf products and kits into the CAR-T service business through contract manufacturing and development or CDMO. To that end last week, we were pleased to announce that our ThermoGenesis subsidiary signed an exclusive license agreement with IncoCell. The China based CDMO and an affiliate of Boyalife Group, which is also a majority owner in Cesca. Under the terms of the arm's-length agreement, ThermoGenesis will provide discounted X-Series kits, which IncoCell will employ in their CAR-T related CDMO services. In exchange, ThermoGenesis is entitled to a low double-digit percentage of all IncoCell revenue, including any upfront payments, milestones or royalties. China is a very significant market for CAR-T developers with many clinical trials currently underway. This deal with IncoCell is consistent with our goal of moving up the value chain into higher value development services, while at the same time establishing a presence in the large and growing China CDMO of market. We are actively pursuing CDMO opportunities in other key market, including here in the U.S. As a result of our broad CAR-T solution, we see numerous partnering and collaboration opportunities. For example, we can sell off-the-shelf kits to CAR-T developers and research institutions looking to automate parts of the manufacturing process, or we can partner in the actual development of the next wave of CAR-T therapeutics with our future CDMO capabilities. Our goal is to be flexible and to be able to address the needs of many different constituents within the CAR-T industry and broader immunotherapy ecosystem. Early discussions with potential partners have been productive and we look forward to providing more specifics on future calls. In addition to CAR-TXpress, we continue to innovate with our other product lines. Last month, we announced the launch of our second generation AXP II system for the advanced isolation, collection and storage of hematopoietic stem cell concentrates from cord blood and peripheral blood. Since 2006, ThermoGenesis has been regarded as an industry leader in the volume reduction processing of cord blood, and AXP too represents the most significant advancement in automated cord blood processing in several years. We count many of the world's leading public and private cord blood banks among our current longtime customers, a strong validation of this technology. We are proud to say that ThermoGenesis remains a pioneer in the development and commercialization of automated technologies for both cell-based therapeutics and bioprocessing, providing the market with a portfolio of products that offer distinct advantages, including hands free operation, high volume processing and recovery rates that are among the highest in the industry. The most recent introduction of AXP II and CAR-TXpress reflect the continuation of our top tier position in the field. In closing, I believe the progress that we have made in recent months sets us up for a transformative and successful year ahead. And with that, I’ll turn the call over to Jeff for a more detailed review of the financials. Jeff?

Jeff Cauble: Thank you, Joe. Before we get into financial details, I’d like to remind you that we have transitioned from a June 30th to a December 31st year end. As such, the transition period financials we are discussing today are for the six months ended December 31, 2017 and the next quarterly report in May will reflect our first quarter 2018 results. Now, turning to the financial results. Net revenues for the six months ended December 31, 2017 were $6 million compared to $7.8 million for the six months ended December 31, 2016. Revenues are impacted by AXP disposables, which had lower sales due to a single end user customer purchasing larger than normal orders to stock up inventory levels in last year’s December quarter, and the one-time shipment of our remaining inventory associated with the discontinuing product line. Offsetting these decreases was an increase in sales of our BioArchive devices as we sold eight during the six months ended December 31, 2017 as compared to nine in the six months ended December 31, 2016. Gross profit for the six months ended December 31, 2017 was $2.2 million or 36% of net revenue compared to $2.9 million or 38% of net revenue for the comparable period in 2016. The slight decrease in gross profit percentage is primarily due to higher overhead costs as a result of the merger with SynGen and our mix of products sold. Sales and marketing expenses for the six months ended December 31, 2017 were $935,000 as compared to $775,000 for the six months ended December 31, 2016. The increase is primarily due to higher personnel costs related to filling previously open positions and the transition of the X-Series product lines to ThermoGenesis. Research and development expenses for the six months ended December 31, 2017 were $2.2 million compared to $1.4 million for the comparable period in 2016. The increase is primarily due to additional headcount and expenses related to the development of our CAR-TXpress platform. General and administrative expenses for the six months ended December 31, 2017 were $3.6 million compared to $6.3 million for the same period in 2016. The decrease is driven by a reduction in severance and accelerated stock expenses of approximately $1.8 million for the termination of the former CEO in November 2016, and a decrease in legal expenses of approximately $1 million, primarily due to the settlement of the SynGen litigation. At December 31, 2017, the company had cash and equivalents of $3.5 million and working capital of $6 million compared to cash and equivalents of $3.6 million and working capital of $7.6 million at June 30, 2017. That concludes our prepared remarks and now we'd like to open the call to your questions. Operator?

Operator:

Chris Xu: Thank you again for joining us this afternoon. I hope that you come away with today’s call with perhaps a better understanding of why we’re so generously enthusiastic about our prospect of Cesca’s positive impact in the Cart-T market. With our unique, fast and more efficient technology, we are pleased to have sign out first the CDMO collaboration and our recent developments are yielding productive discussions with many different potential partners. This is truly a transformational time here at Cesca. And we look forward to updating you again our next call.

Operator: The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.