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BioLife Solutions, Inc.
11/9/2022
In light of our M&A activity, we believe that the use of non-gap or adjustment 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, Chairman and CEO of BioLife Solutions.
Thanks, Troy, and good afternoon, everyone. Thank you for joining our call. After my remarks, Troy will present our financials for Q3 in nine months of 2022, and Rod will provide an operations update. After that, we'll be glad to take your questions. Turning to Q3 revenue and customer highlights. Despite several macro headwinds, also cited by our peers in the life science tool space, our team delivered another strong performance in Q3. Total revenue was $40.7 million, up 21% from Q3 2021, with organic revenue growth of 18%. A key highlight of Q3 was biopreservation media revenue growth of 50%. Our growth catalyst and business fundamentals remain intact, and with improved business visibility and reduced COVID-related revenue, we are once again tightening our full year 2022 revenue guidance, which Troy will cover in a few minutes. To make the point on our revenue differentiation with respect to some of our assumed competitors, in Q3, 44% of total revenue was high margin consumables, and 13% was high margin recurring services revenue, So about 60% is non-hardware related. With the recovery of our UOT freezer platform well underway, with greatly improved quality and no lead times, we look to finish the year strong. Relative to some of our competitors that are offering generic alternatives and mostly instruments, it's critical to note that BioLife is a vastly different company, with hyper-growth of our high-margin recurring consumables media revenue as the anchor from which we expect to drive growth in our entire portfolio. We believe our biopreservation media franchise could easily reach 250 million in revenue within five years, reflecting 30 plus percent annual growth. BioLife remains one of the most highly correlated suppliers to the growth of the global CGT market. In Q3, we sold and shipped products or provided services to 193 new unique customer sites across our three product and services platforms. Most of our revenue comes from existing customers, as we penetrate deeper and pitch our integrated solutions to take more share of their spend for manufacturing, storage, and distribution products and services. In each of the first three quarters this year, we gained about 200 new customer sites, building a phenomenal pipeline of early-stage customers that we will nurture and support to drive future growth. I'll remind you now what our three platforms are. First, self-processing, which includes biopreservation media and Sexton self-processing products. Second is our freezers and thaw systems platform, comprised of cryogenic liquid nitrogen freezers and Sterling ULT mechanical freezers and automated thawing devices. And finally, storage and storage services, which includes our SciSafe storage services and our Evo cold chain management offering. New Q3 customer sites by product line included 14 more now using biopreservation media, 11 new ThaStar users, 12 new Evo cold-chained end users, 14 new cryogenic freezers and accessory customers, 114 new Sterling ULT freezer and accessory customers, 18 new BioStorage customers, and 10 new self-processing customers now using Sexton products. For self-processing in Q3, we gained 24 new customers, and receive confirmation that our self-processing solutions will be used in at least 20 additional clinical trials for new cell or gene therapies. We estimate that our biopreservation media products have been used in, or are planned to be used in, 570 customer clinical applications. For biopreservation media, we also remain confident that each customer clinical application, if approved, could generate revenue in a range of $500,000 to $2 million annually. To date, our biopreservation media is used in 11 approved therapies, and our sextant self-processing media and vials are used in three approved therapies, including Brianzi from BMS, Imcinar from Riacelle, and Relmacelle from JW Therapeutics. Note, all of these also use our CryoStor biopreservation media. Our biopreservation media products are also embedded in at least 10 additional anticipated approvals by the end of 2023. I'll conclude by saying that our biopreservation media clinical customer base includes most of the CAR T cell developers with our proprietary products embedded in a majority of the autologous and allogeneic platforms currently in development. We expect to be able to continue to take share from homebrew preservation cocktails as awareness grows of the critical role our engineered media formulations play in reducing risk for CGT companies. In addition to the initial approvals of new cell and gene therapies, We also see the recent and pending approvals of CGT products for first- or second-line treatment and approvals for additional indications and the new geographies as four growth catalysts for our biopreservation media and other solutions. For the other part of our self-processing platform, our section products, adoption and customer clinical applications includes 67 using HPL media, 62 using Celsius vials, and three using automated film machines. So you can see we're running a biopreservation media playbook to drive adoption of Sexton products. We estimate that annual revenue for Sexton reagents and consumables used in approved customer therapies ranges from 500K to 1 million for both Celsius vials and HPL media. Turning to our freezers and thaw systems platform, to reiterate, we ship first-time orders to 139 new customer sites. Our hyper-focus on the acquired Sterling platform have resulted in greatly improved quality and reduced shipping lead times, which Rod will speak to on this call. Customers continue to see the value proposition of our ULT freezer offering, based on tight temperature regulation, reduced power consumption, reduced heat generation, and less noise pollution, as these support their goal of reducing the negative environmental impact of their operations. In our final of three revenue platforms, storage and storage services, which includes EVO cold chain rentals and SciSafe storage services, we either shipped first use products or engaged for initial services with 30 new customer sites in Q3, 18 for storage services and 12 for EVO. Our SciSafe storage services platform is growing rapidly. We are now considering multiple locations for our new buyer repository plan to open in 2023. With our EVO cold chain management platform, Cell and gene therapy companies now have broad access to our class-defining offering through our expanded specialty courier partner network that now includes World Courier, Quick International, Pathion Thermo Fisher, Marken, and BioCare. We're very excited about our market opportunity to drive our Evo platform to become a meaningful revenue and profit contributor. Q3 Evo shipments over 2000 were up 100% over the same quarter last year, Of these, we estimate at least 75% were for approved therapies and the rest were for clinical trials. We're collecting a huge amount of shipment information that is shaping our continued Evo IS cloud innovation to give our courier partners and NCGT customers even more actionable data to reduce risk. We continue to expect that by mid-next year, the Evo platform will be used for all of the currently approved CAR T-cell therapies. This adoption validates our belief that the EVO platform will increasingly be selected as a class-defining, temperature-controlled shipping container and related cloud app by the leading CGT companies. Now I'll turn the call over to Troy to present our financials for Q3. Troy? Thank you, Mike.
Total revenue for the third quarter of 2022 totaled a record $40.7 million, representing a 21% increase over Q3 of 2021. Organic revenue growth was 18%, driven by a 50% increase in biopreservation media revenue of $16.6 million. COVID-19 related revenue accounted for approximately 9% of total revenue in the quarter. Cell processing platform revenue was $18.1 million, up 57% over the same period in 2021, and organic growth was 50%. Freezers and thaw systems platform revenue was $15.3 million, Total and organic growth was down 13% over the same period in 2021. COVID-19-related revenue accounted for approximately 4% of the freezer and thaw systems platform revenue versus 23% last year. Storage and storage services platform revenue was $7.3 million, with both total and organic growth of 56% over the same period in 2021. COVID-19-related revenue accounted for approximately 40% of the storage and storage services platform revenue. Total revenue for the nine months ended September 30, 2022, was $117.5 million, an increase of 44% over 2021, with organic growth of 44%. Adjusted gross margin for the third quarter of 2022 was 34%, compared with 26% for the third quarter of 2021, and 36% for the second quarter of 2022. For the first nine months of 2022, adjusted gross margin was 34%, compared with 39% in the same period last year. The quarterly sequential decline in Q3 gross margin was largely due to supplier quality issues impacting yield and customer mix, partially offset by lower warranty costs. we expect to see increases in gross margin in Q4. GAAP operating expenses for Q3 2022 were 52.2 million versus 45 million in Q3 2021. And for the first nine months of 2022, GAAP operating expenses were 212.8 million, which includes the non-cash intangible impairment of 69.9 million related to the global cooling acquisition recorded in Q2. Compared with 2021, nine months ended GAAP operating expenses of $98.5 million. Adjusted operating expenses for Q3 2022 were $20.5 million compared with $17.4 million in Q3 of 2021 and $20.0 million in Q2 2022. For the first nine months of 2022, adjusted operating expenses were $60.3 million compared with $39.5 million in the first nine months of last year. Adjusted operating expenses increased due to the 2021 acquisitions of Global Cooling and Sexton. In addition, operating expenses increased due to higher accounting costs and increased headcount to support our growth. Adjusted operating expenses increased by $420,000 over the previous quarter, primarily due to increased accounting fees. Adjusted operating loss for the third quarter of 2022 was $6.7 million compared with adjusted operating loss of $8.1 million in the third quarter of 2021. Our adjusted operating loss for the first nine months of 2022 totaled 20.2 million compared with adjusted operating loss of 7.5 million in 2021. Adjusted EBITDA for the third quarter of 2022 was positive 1.4 million compared with negative 2.1 million for the third quarter of 2021 and positive 2.2 million for the second quarter of 2022. For the first nine months of 2022, adjusted EBITDA was positive 2.8 million compared with 4.4 million in the same period in 2021. We expect higher adjusted EBITDA in the second half of 2022 compared with the first half of 2022. Our cash and marketable securities balance at September 30th, 2022 was 61.7 million compared with 46.6 million at June 30th, 2022. On September 20th, we closed a $50 million secured loan agreement with Silicon Valley Bank and advanced $20 million on this facility. We have $30 million of additional facility to draw upon prior to June 30th, 2023, which is comprised of 10 million upon the company's discretion, 10 million upon achieving a revenue milestone, and an additional $10 million upon SEB's discretion. The loan matures on June 1, 2026, although it may be extended to June 1, 2027, upon the occurrence of certain conditions. The interest rate is the greater of 5.75% or Wall Street Journal Prime plus 50 bps, subject to an overall interest rate ceiling of not more than 1% above the time of the advance. Our first 20 million advance has an interest rate ceiling of 7% and has no financial covenants. On repayment and full of the loans, we will pay an additional 5.75% of the aggregate principal amount extended. Taking into consideration our loan advance and adjusted EBITDA of positive 1.4 million, cash use in Q3 2022 was related to capital expenditures of 3.9 million, primarily related to the build-outs of our biorepository facilities and a debt repayment of 1.8 million, which was partially offset by cash provided by operations of 1.5 million. Turning to 2022 revenue guidance, we have tightened full-year revenue guidance to be in the range of 160 million to 164 million versus prior guidance of $160 million to $166 million. Our guidance reflects year-over-year growth of 34% to 38% and organic growth of 37% to 40%. COVID-19-related revenue is expected to account for approximately 7% to 8% of total revenue. Total revenue expectations for 2022 include the following platform updates. For our cell processing platform, lowered the top range of our guidance by 1.5 million, reflecting the potential for a supply chain challenge that could delay shipments. Full year 2022 platform revenue is now expected to be between 67 million to 68 million, an increase of 49% to 51% over 2021, and organic growth of 42% to 43%. Any 2022 orders that are delayed are expected to ship in Q1 of 2023. For our freezers and thaw systems platform, we decreased the bottom range by $4 million and decreased the top range by $3.5 million. Full year 2022 platform revenue is now expected to be between $66 million and $68 million, reflecting supply chain challenges on our cryogenic freezer product line. This guidance represents growth of 17% to 20% over 2021 and organic growth of 8% to 13%. COVID-19 related revenue is estimated to account for 3% of the freezer and thaw systems platform revenue. For our storage and storage services platform, we increased the bottom range by 4 million and increased the top range by 3 million. and is now expected to be between 27 million to 28 million with total and organic growth of 54% to 59% over 2021. COVID-19 related revenue is expected to account for an estimated 40% to 45% of the storage and storage services platform revenue. The COVID-19 related revenue is primarily based on contracts and therefore We do not expect to see variability on this number through the balance of the year. In addition, our COVID contract that extended into 2023 has been amended in November to store therapies instead of COVID vaccines. Therefore, we expect minimal COVID revenue in 2023. In terms of our new share count, as of today, we have 42.8 million shares issued in outstanding, and 45.4 million shares on a fully diluted basis. Lastly, as this is Rod's last earning call, I'd like to thank him for all his contributions to BioLife and being a true team player. You've made a positive impact on this organization, and for me, on a personal level as well. I wish you the best in a well-deserved retirement, and I look forward to working with you on the board. Now, I'll turn the call to Rod.
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