Mike Rice
Analyst · KeyBanc. Your line is open
Thanks, Rod and good afternoon everyone. Thank you for joining our call. We are very pleased to present the background, strategic rationale and synergies as well as the potential financial impact of our just announced acquisition of Stirling Ultracold, a company that’s been in the news quite a bit these last few months due to their support of COVID-19 vaccine distribution and point-of-care storage. Before I get to Stirling, I would like to give some color on how we finished last year. I’ll provide some quantitative data, but I’ll leave most of the detailed revenue presentation to Rod. To set the context, it’s important to review how active the cell and gene therapy space is right now. In 2020, total funding for companies participating in the space was nearly $20 billion, a 50% increase over 2019. Industry-sponsored clinical trials increased by 154 over 2019 and several therapeutic candidates could get approved this year. 2020 was a banner year for BioLife with total revenue of $48 million, up 76% over 2019. 2020 media revenue grew 32% over the prior year. We gained over 200 new direct customers with new end users across the portfolio, including media, thaw, evo Cold Chain, CBS freezers and SciSafe storage services. Additionally, our two largest distributors sold and shipped our preservation media products to nearly 3,500 different customers. This is truly remarkable and speaks to how well our direct sales team and distribution partners are planting seeds for future growth. Further to our media franchise, since 2016, we processed nearly 300 cross-reference requests for our U.S. FDA master files to support media use in human clinical trials. In 2020, we added 63 new media customers, and we also added 75 new customer clinical trials using our media, including 30 in the fourth quarter alone. It’s not a perfect data match up, but if we take the ARM data of 154 new clinical trials in 2020, it’s possible our market share is nearly 50% of these, considering we added 75 new trials last year. We continue to believe that our media franchise of really sticky marquee customers is the engine that will continue to leverage to market our growing bioproduction tools and services portfolio to. To-date, our biopreservation media is used in four approved cell therapies; Yescarta and Tecartus from Kite; [indiscernible] from Celgene; and Zynteglo from bluebird. CryoStor is also used in four new therapies that could get approved this year. These include ide-cel from Celgene, Omidubicel from GamidaCell, Cilta-cel from Janssen and eli-cel from Bluebird. So we could start to see the anticipated growth in customer approvals this year and continuing for several years, considering our large installed base of media customers still in the clinic and marching toward filing for approvals in various geographies. Turning to our CryoStor products, although the pandemic significantly limited our ability to sell on-site in person at customer and prospect locations, we gained 11 new customers in Q4 last year and 29% for the full year 2020. Turning to our evo Cold Chain management platform, we continue to gain traction and added 14 new customers in Q4 last year. The large pharma company, we’ve been working with to secure some portion of the commercial shipments has confirmed that they’ve completed their regulatory update filings, citing the EVO platform in the U.S. and Europe. And we are on schedule to commence a series of monthly deliveries of evo containers to our courier partners to support customer shipments using evo next quarter. We believe that over time, this customer decision to derisk cold chain management by approving more than one container and logistics provider will become the norm and we will have a strong opportunity to compete across the landscape of cell and gene therapies. In the last few months, we also onboarded two new courier partners with Biocare and Fisher BioServices joining World Courier and Quick as approved evo partners targeting the cell and gene therapy space. With our CBS freezer platform, again, the pandemic curtailed much of our on-site selling activities. However, we finished last year on a strong note and gained 19 new customers in Q4 2020. Rounding up my recap, our biostorage services team had a very strong Q4 and full year 2020. We gained 6 new customers in Q4 and set the stage for significant growth this year with expansion underway in the U.S. and Europe. Starting with this call and onward, based on the guidance and requests we’ve directly received from several government agencies, we’re not going to discuss SciSafe customers and involvement with COVID vaccines. So just a heads up for when we get to the Q&A portion of this call. In summary, we are really pleased with what we accomplished last year and are confident about our organic growth potential and how the acquisition of Stirling will take BioLife to the next level. Now, turning to the transaction, joining Rod and me on the call today is Dusty Tenney, the current CEO of Stirling Ultracold, who will be joining BioLife Solutions, after we close the transaction, as our new President and Chief Operating Officer. Dusty has a proven track record of scaling high-growth businesses at Brooks Automation and before that at PerkinElmer. And I am really looking forward to his contributions in scaling the business. We are thrilled to welcome Dusty and the entire Stirling team to the BioLife family. With our acquisition of Stirling, we’re now guiding 2021 total revenue in a range of $101 million to $110 million and have set our next revenue goal at $250 million within the next 3 to 4 years. I will start off with a recap of our M&A strategy and then comment on why Stirling is such a great fit for BioLife. Recall that in August 2018, we embarked on a strategy to identify and acquire or invest in novel and potentially disruptive technologies that would broaden our tools portfolio and enable us to help our cell and gene therapy customers to decrease the potential of delivering a nonviable dose. With reimbursement being predicated on an initial and sustained response from the patient and our understanding of the many ways manufactured cell and gene therapies can be damaged during storage, shipping and filing, we looked at the fragmented tool supplier base and got to work. The merger with Stirling is our fifth deal in the last 2 years, following our acquisitions of Astero Bio in the ThawSTAR product family; SAVSU Technologies and the evo Cold Chain management platform; Custom Biogenic Systems’ liquid nitrogen freezers; and most recently last October, SciSafe and their biologic storage services offering. We focused on the mechanical freezer landscape since we currently don’t offer that temperature range in our freezer portfolio, which is limited to minus 196C. Mechanical freezers operate in a range from minus 20C to minus 80C, a key requirement of our strategy to enter the mechanical freezer market. We used to identify technologies that are not prone to the typical compressor failures and maintenance requirements of the current market offerings. The Stirling Freezer platform is a novel, utilizing a very efficient Stirling engine and no compressors, providing much higher reliability and uptime on standard compressor-based technologies. There are just 2 moving parts and the energy consumption is a fraction of compressor-based freezers, creating significant operational benefits. These are the typical reasons that customers buy from Stirling, but the most compelling reason is that all Stirling freezer systems, the portable ULT-25, the under-counter SU105 and the upright 780XLE, all have programmable ultra-low temperature ranges between minus 20C and minus 86C, which provides customers universal applications for their biologic materials and vaccines that no other system in the world can provide. So with this acquisition, we now have complete cold chain freezer line from minus 20C to minus 196C that fulfills 100% of the needs of cell and gene therapy developers and the broader biopharma market. The strategic fit is excellent. In addition to welcoming the 18 person strong Stirling Global Direct sales team to BioLife who will now also present our CBS liquid nitrogen freezers to customers, we have an operational and cost synergy to leverage and that SciSafe is a major customer of Stirling, so we’ll be supplying one operations team from another. Lastly, we will pickup 80 patents from the acquisition related to Stirling’s current and future products that will enable strong sustained product differentiation. Now, I would like to turn the call over to Dusty to give you a background on Stirling, and then Rod can take us through our 2020 financials and the impact of the Stirling acquisition. Dusty?