ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc.

THMO
ThermoGenesis Holdings, Inc.US flagOther OTC
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1,585.00Market Cap

Q1 2018 · Earnings Call Transcript

Nov 14, 2017

APIChat

Executives

Paula Schwartz - Rx Communications Chris Xu - Chairman and Chief Executive Officer Jeff Cauble - Principal Accounting Officer

Analysts

Operator

Good afternoon and welcome to the Cesca Therapeutics Fiscal 2018 First Quarter Financial Results Conference Call. We would like to review that operating results for the three months ended September 30, 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. I'd 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 could cause -- 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, November 14, 2017. If any portion of this call is being rebroadcast, retransmitted, or redistributed at a later date, Cesca will not be reviewing nor updating this material.

Participating on today's call are Dr. Chris Xu, CEO; and Jeff Cauble, Principal Accounting Officer.

Please proceed Chris.

Chris Xu

Thank you, Paula. Good afternoon everybody, and thank you for joining us.

I’ll start by providing a strategic and operational updates, and then Jeff will follow with reviews of the financials. Since our last quarterly update, we have continued to make excellent progress integrating the cell processing assets of SynGen , which we acquired in July to create one of the most comprehensive cellular processing solution sets in the industry.

SynGen perfectly complements our legacy Cesca portfolio of systems and positions us now to be the leading player in a rapidly emerging field of CAR-T cell manufacturing. To that end, we are developing a new, fully automated platform called CAR-T Express to [indiscernible] able to developers to manufacture high quality, clinical grade CAR-T cells in a closed system at a robust scale to provide those groundbreaking treatments to as many patients as possible.

New CAR-T-based treatments, which are at the forefront of personalized medicine are showing tremendous promise in the treatment of cancer. But since each therapy is unique to a patient that the process is expensive and time-consuming, and does not align with the traditional biopharmaceutical business model.

Specifically, during CAR-T therapy, a patient’s blood is drawn and shipped to a central location where T cells are separated and genetically engineered to identify and attack cancer cells. Those cells are then returned to the original treatment site and re-infused into the patient.

The entire process, which is now known as the vein to vein time, can take several weeks. As more CAR-T therapies come to market, we firmly believe that factors like cost, speed, and consistency will be critical success factors in getting those groundbreaking treatments to as many patients as possible, of course as fast as possible, and we expect demand to be strong.

Automation is key to those efforts, and as we work to adapt our Auto Express Platform Technology to this exciting new field, we are seeing significant in-bound interest from potential collaborators, including pharmaceutical companies, medical technology companies, and academic institutes, and distributors. As a reminder, our CAR-T Express 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 microbubbles bear antibodies on their surface, enabling them to bind specifically to a single desired target cell type.

When coated with microbubbles, the target cells float through the top of the host liquid, while non-target cells sink through the bottom. This is a process that can be accelerated by centrifugation.

Subsequently collecting of the floating target cell layer and release of the cells from their microbubbles provides a highly purified preparation of just the cell of interest, with high recovery efficiency while retaining cell viability. Phil Coelho, who joined Cesca team with our acquisition of SynGen and currently serve as Chief Technology Officer of our thermogenesis division is a pioneer and thought leader in the BACS cell separation technology.

During September quarter, we had received a notice of allowance from the USPTO for a second patent related to BACS Technology, which we now refer to as X-BACS. When issued, this patent will complement with the 394 apparatus patent that was issued in July 2017 and will further solidify our IP surrounding its novel best-in-class technology.

To recap, our current thermogenesis product line includes AutoXpress or AXP. This is a proprietary automated system for the isolation and collection of hematopoietic stem cell from cord blood and peripheral blood.

MXP, which is for the rapid automated processing of autologous, peripheral, or bone marrow derived stem cells for cell based therapies and the point of care situation such as surgical centers or clinics. So the CAR-TXpress or CXT we are developing CAR-TXpress as the corner stone of a broad immuno-oncology offering that we envision while include everything from off-the-shelf cellular processing systems to a highly customized contract manufacturing and co-development programs.

With CAR-TXpress, we will be able to address each of our customers’ unique automation needs. And finally, BioArchive, which was an automated single cassette-based cryogenic system used for cryopreservation and storage of cord blood derived stem cells as well as CAR-T cells.

Our cellular processing solutions offer several distinct advantages in the marketplace, including hands free operation, high volume processing, and recovery rates that are among the highest in the industry. Our plan is to be well-positioned with broad distribution coverage that ensures access to the most important CAR-T key market in the world.

During September quarter, we announced a distribution agreement with Boyalife, WSN Limited covering India. China, Singapore, and the Philippines.

China in particular will be critical as we pursue collaborations since many of the ongoing CAR-T trials have sites within China. We are working with Boyalife WSN, our preliminary marketing and distribution client, so that we can hit the ground running in those key markets.

Now turning to our second division which includes our clinical programs. Our lead program is evaluating a derivative of our autologous cell-based therapies to treat patients with critical limb ischemia or CLI.

Critical limb ischemia is a severe form of peripheral artery disease, and late stage patients suffering from this condition typically have no remaining therapies or treatment options other than amputation. As some of our listeners will recall, our early CLI feasibility study yielded very promising results with 17 study participants experiencing improved wound healing, rest pain, and six-minute walking distance, along with a significant reduction of intermittent claudication pain.

We have received FDA approval for an IDE supplement for our revised CLI clinical trial design. That said, given that our near-term strategy focus is growing our thermogenesis device business and developing CAR-TXpress , our aim with regards to CLI is to find a strategic partner to further advance this promising new therapeutic option.

To that end, we are continuing to pursue discussions with potential partners and we will provide a further update when development warrants. In closing, I believe the progress that we have made in recent months sets us up for a transformative and a successful year ahead.

And with the acquisition of SynGen, we believe that we will be in -- we will be recognized as a leading global developer for automated cell processing solutions. As such, we aim to leverage these significant opportunities before us.

Most especially, within the exciting and growing field of CAR-T therapy. And with that, I’ll turn the call over to Jeff for a more detailed review of our financials.

Jeff?

Jeff Cauble

Thank you, Chris. Before we begin the financial details, I would like to remind you the upcoming change to our fiscal year that we discussed on our last quarterly call.

Our Board of Directors has approved a change in our fiscal year-end from June 30 to December 31. As a result, in addition to the 10-Q filed today, for the 3-months ended September 30, 2017, next quarter we intend to file a transitional Form 10-K for the six months ended December 31, 2017.

And then moving forward, beginning in 2018, our fiscal year will end on December 31. Now turning to the financial results.

Net revenues for the three months ended September 30, 2017 were $3.1 million compared to $3.8 million for the three months ended September 30, 2016. The decrease was anticipated as is primarily due to a one-time shipment of the remaining inventory associated with the discontinued product line, Rescue and AXP disposables which had lower sales due to a single end-user customer purchasing larger than normal orders to stock up inventory levels in the quarter ended September 30, 2016.

Offsetting these decreases was an increase in sales of BioArchive devices. As the company sold three during the quarter ended September 30, 2017 as compared to none in the same quarter last year.

Recently, there has been a significant increase in BioArchive device sales. In the last two quarters, the Company had sold five BioArchive Devices as compared to only two in the previous seven quarters combined.

This trend is expected to continue with approximately 2 to 3 devices sold per quarter for at least the next three to four quarters. Gross profit for the three months ended September 30, 2017 was $931,000 or 30% of net revenue compared to $1.4 million or 37% of net revenue for the comparable period in 2016.

The decrease in gross profit margin was primarily due to an increase in inventory search for the MXP product line and increase in overhead expenses due to the company's acquisition of SynGen and mix of products sold. Sales and marketing expenses for the three months ended September 30, 2017 were $517,000 as compared to $481,000 for 3 months ended September 30, 2016.

The slight increase is primarily due to higher personnel costs from the SynGen acquisition. Research and development expenses for the three months ended September 30, 2017 were $1.1 million compared to $670,000 for the comparable period in 2016.

The increase was driven by the SynGen acquisition and additional project spending related to new product development. General and administrative expenses for the three months ended September 30, 2017 were $1.7 million compared to $2.2 million for the same period in 2016.

The decrease is primarily due to lower legal expenses resulting from the settlement of the SynGen litigation and lower severance expenses as compared to the quarter ended September 30, 2016. At September 30, 2017, the company had cash and equivalents of $2.5 million and working capital of $5.3 million compared to cash and equivalents of $3.6 million and working capital of $6.7 million at June 30, 2017.

As of September 30, 2017, we had an additional 5 million in cash available to draw down from our unsecured line of credit which is backed by Boyalife Investment Fund II . That concludes our prepared remarks.

And now we'd like to open the call for your questions. Operator?

Chris Xu

Thank you everybody for participating on today's call. We are enthusiastic about our growth perspective and we look forward to updating you our future progress.

Thank you.

Operator

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

You may now disconnect.