8/6/2020

speaker
Rebecca
Conference Call Operator

Welcome to the BioLife Solutions second quarter 2020 conference call. My name is Rebecca, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star then 1 on your touch-tone phone. Please note that this conference is being recorded. I will now turn the call over to Roderick de Greef, Chief Financial Officer. You may begin, sir.

speaker
Roderick de Greef
Chief Financial Officer

Thank you, Rebecca. Good afternoon, everyone, and thank you for joining us for the BioLife Solutions conference call to review the operating and financial results for the second quarter of 2020. Earlier this afternoon, we issued a press release which summarizes our financial results for the three and six months ended June 30th. As a reminder, during this call, we may make certain projections and other forward-looking statements regarding future events, future financial performance of the company. These statements are subject to risks and uncertainties that may cause actual results to differ materially from expectations. For a detailed discussion of the risks and uncertainties that affect the company's business and that qualify as forward-looking statements, I refer you to our periodic and other public filings filed with the SEC. Company projections and forward-looking statements are based on factors that are subject to change. Therefore, these statements speak only as of the date they are given. The company assumes no obligation to update any projections or forward-looking statements, except as required by law. During the call, we will speak to non-GAAP or adjusted results. Reconciliations of GAAP to non-GAAP or adjusted financial metrics are included in the press release we issued this afternoon. These non-GAAP or adjusted financial metrics should not be viewed as an alternative to GAAP. In light of our M&A activity, we believe that the use of non-GAAP or adjusted metrics provides investors with a clearer view of our current financial results when compared to prior periods. Now I'd like to turn the call over to Mike Rice, President and CEO of BioLife.

speaker
Mike Rice
President and CEO

Thanks, Rod, and good afternoon, everyone. Thank you for joining our call. Q2 was another quarter of solid execution and growth, despite the challenges all of us are facing due to COVID-19. We grew top-line revenue by nearly 50%, generated positive adjusted EBITDA, gained 48 new customers, and just after the end of the quarter, completed an oversubscribed $86 million follow-on offering to strengthen our balance sheet for further M&A activity. We're in a good place. Serving the cell and gene therapy industry is rewarding, and we're building a great business. We're armed with a leading brand with our media products and are leveraging our media customers to expose our expanded portfolio to the region med space. were now all capitalized to continue to build for a bigger and more profitable future. The region med space is white hot right now, with $10 billion raised by companies in the first half of 2020. Now I'll provide some Q2 highlights for each product line. For biopreservation media in Q2, revenue was up 5% year over year and up 27% year over year for the first two quarters of 2020. Recall that in Q1 this year, in response to our customer outreach program, We booked about 1.5 to 2 million in COVID-related safety stock orders. Media orders so far in Q3 are strong. We gained 14 new media customers in Q2, including Caribou Biosciences, Immunoactiva, Indapta, Minerva Biotechnologies, and Neoprogen. Also in the quarter, we processed 14 new US FDA master file requests to support the use of our biopreservation media products in new cell and gene therapy clinical trials. We now estimate that our media products are used in, or are planned to be used in, about 450 customer clinical applications. Relevant to the current pandemic, we have at least seven customers using our media in at least nine planned or current clinical trials of COVID-19 therapies or vaccines. These include Aveda Biomedical, Capricor, Cartesian Therapeutics, Cilencos, Mylar Therapeutics, Neoprogen, VetStem, and Vitro Biopharma. Regarding use of our media products in approved cell therapies, I'm glad to confirm that Gilead Kite uses CryoStor in their recently approved Tocardis for relapsed to refractory mantle cell lymphoma. This is in addition to Kite's longstanding use of CryoStor in Yaskarta. Also, Bristol-Myers Squibb and Bluebird Bio filed for approval of idicaptogene viclacel, also known as Idicel or BB2121 as a treatment for multiple myeloma, if approved This would be the first CAR-T cell therapy to treat the second most common form of blood cancer. Cryostor is used in the manufacture of BB-2121. I'll remind you that Cryostor is also used in Lysacell, a cell therapy for relapsed to refractory large B-cell lymphoma from Juno Celgene BMS. The revised VEDUFA date for Lysacell is November 16th. Cryostor is also used in Zynteglo from Bluebird. We have so many shots on goal here with our base of cell and gene therapy customers. Many of you remember that former FDA chief Scott Gottlieb predicted in January 2019 that by 2025, the agency will be approving between 10 and 20 cell and gene therapy products annually. This all points to tremendous upside for BioLife. Automated Thaw revenue and Evo cold chain revenue were on plan in Q2. We gained five new Thaw Star customers and six new Evo customers. Working with our courier partners, We've jointly driven adoption of the EVO platform to now be supporting over 100 clinical trials. It's important to note that these are all early phase trials, so the shipment volume is low, and hence the revenue is relatively small. But we're confident the EVO platform will emerge as a leading cold chain management preference in the cell and gene therapy space, and notably, it continues to support an approved cell therapy company in their evaluation. So far, the validation work is on track, and we believe if we win this customer, Similar to how our media products were broadly adopted after Kite, Juno, and others adopted, this cold chain customer win could greatly accelerate adoption of the EVO platform in the cell and gene therapy space. Turning to our CBS freezer franchise, COVID-19 has impacted us in two ways, in travel and onsite visitor restrictions at customer and prospect sites, and also a delay in approvals for large capital equipment purchases. Despite this environment, We gained 23 new customers that purchased freezers or related racks and accessories in the second quarter. Product development on two new freezer platforms is continuing, and we anticipate launches late in Q4 or in Q1. We're also making good progress to vertically integrate and use our foundry at CBS to manufacture the EVO dry vapor shippers for our cold chain management platform. We expect to offer CBS-made doers in the first quarter of next year. I'll conclude my remarks with a recap of our funding activity this year. with a follow-on $20 million investment from Kasten Capital in May and the $86 million oversubscribed public offering we completed just after the end of Q2, BioLife is in great shape to continue to consolidate the cell and gene therapy bioproduction tool space. We're actively engaged in additional M&A and investment discussions and look forward to sharing the details when we can. Now I'll pass the call back over to Rod to present our financials for Q2. Rod?

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