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spk10: 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.
spk04: 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.
spk10: 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.
spk05: Thanks, Troy. It's been a year since I moved into my current role. As I reflect on the last 12 months, I'm pleased to say that significant operational progress has been made, not just at Sterling, where we had some very acute issues, but across other product platforms as well. The efforts of our operations, quality, and customer service teams throughout the company have positioned us for continued strong execution in 2023. The operational metrics at Sterling continue to improve positively impacting gross margin through lower warranty utilization this quarter compared to historical levels. Our previously announced plans to move the manufacturer of two of the three ULT products from an existing CMO to our Michigan facility are well underway, and units are expected to be built in-house by the end of Q1 of next year. Our Athens facility will continue to focus on increasing production efficiencies on the 780 XLE freezer and prepare for the launch of the next generation large capacity freezer. In Q3, as we continue to focus on overall gross margin and operational improvements, we also made the decision to relocate all of our EVO production, quality, and logistics activities to our Michigan facility, keeping customer service and engineering activities in a smaller Albuquerque facility We expect DV10 production to begin in Michigan in Q1 of next year. In addition to bringing the EVO and two ULT production lines into our LN2 freezer facility, we have been finalizing the validation of a second source for a key component used in our LN2 freezer line and expect to begin shipping products using this new supplier before the end of the year. This new supplier relationship mitigates consistent supply constraints, which have had an ongoing negative impact on revenue in recent quarters, and it also yields cost savings, which positively impacts gross margins on these products in 2023. Moving on to our biopreservation media products, we continue to make progress working through existing supply chain constraints, and based on continued higher-than-expected demand, we are focused on increasing capacity in the near and midterms. To that end, in Q3, we finished the validation process involved in moving from 100 to 200 liter media batches and are currently producing our lead product, CryoStor, at that volume. Increased production in the coming quarters should allow us to meet continued growing demand and replenish our safety stock, which has been depleted in the last year. In addition, we are now executing on our plan to establish a small, but scalable biopreservation media production suite at our facility in Indianapolis and expect that facility to begin producing our smaller volume product runs by mid-2023, which will enable us to dedicate our BOPL production slots to the larger volume runs. Finally, with respect to the two other key operational initiatives, establishing a high-margin service revenue program and our NetSuite ERP implementation, I'm pleased to report that our pilot service revenue program is expected to exceed $700,000 in revenue this year. We expect service revenue and related gross margin to have a larger impact on our financial performance in 2023. While a majority of our accounting functions are now running on NetSuite, the balance of the implementation has encountered some delays based on bandwidth constraints, and we now expect to have the full accounting and manufacturing applications up and running by the middle of next year and middleware connectivity to numerous other applications entity-wide by the end of 2023. As I move from my operational role to a seat on the board early next year, I'm very confident that the company's operations will continue to progress under the new leadership team I've worked so closely with over the last year. Now I'd like to turn the call back over to Mike.
spk04: Thanks, Rod. Now I'll summarize our key takeaways from Q3 and for the rest of 2022. First, BioLife Solutions is a critical, highly trusted tools and services provider to the cell and gene therapy industry. We've built a valuable portfolio of risk-mitigating solutions that help CGT developers increase their likelihood of success. Second, demand for our portfolio of class-defining bioproduction tools and services remains strong. We expect full-year 2022 revenue to fall within the guidance update we just issued. Our high-margin proprietary media business is booming, and let's all remember that we're still in the early innings of CGT approvals, and we have hundreds of shots on goal. This is really sticky, recurring consumables revenue, with the traditional homebrew alternatives becoming much less often considered and selected. Number three, our Sterling product line is notably differentiated, and we expect to drive demand and capture share in the high-growth CGT and global pharma segments. And lastly, we remain very confident that we will achieve our Q4 2024 run rate aspirational financial goals of $250 million in revenue, 50 points of adjusted gross margin, and 30 points of adjusted EBITDA. Fast forwarding to today, I'm pleased to say that overall, product and services demand so far in Q4 is strong, and we're looking forward to sharing our full year 2022 results. Before I turn the call back over to the operator to manage the Q&A portion, I need to take a minute to recognize Rod's contributions to BuyerLife during his long association with the company. With his retirement coming at the end of the year, this is Rod's last earnings call as he transitions to joining our board of directors. We're so fortunate to leverage his experience and guidance to help us take BuyerLife to our next level of growth and overall solid financial performance. Thank you, Rod, from the entire team. We wish you the best in your much-deserved retirement, and this time we mean it.
spk09: Now I'll turn the call back over to the operator. Dennis?
spk08: If you would like to ask a question, simply press star, then the number one on your telephone keypad. Once again, to ask a question today, please press star, then the number one. Your first question is from the line of Paul Knight with KeyBank. Please go ahead.
spk06: Yeah, thanks a lot. Rod, thanks. I think our years together approach is almost double digits as well. So I hope you enjoy this next round of retirement. And the questions I have, Mike, are how many CGT approvals do you expect again next year? Secondly, Troy, regarding the storage and COVID contract, Is that being replaced by other modalities, or do you think that that COVID number has to come down? And then lastly, Mike, on the per-revenue, per-approved therapy, why do you think it's stickier than ever? You kind of expressed this comment in your finishing comments about homebrew kind of – you know, less and less of an alternative. Why is that? Thanks for those three questions.
spk04: Yeah. Hi, Paul. Thanks. Really good questions. Next year, perhaps 10 additional approvals that our media is baked in. Okay. And that's a combination of U.S. and outside of U.S., predominantly Europe. I'm going to answer your last one, then we'll go back to Tori to take the middle part. So what gives us confidence that the estimated range of annual revenue of an approved therapy of $500K to $2 million per year can hold? A lot of anecdotal data and looking at revenue from our customers who have approved therapies. Now, some of them are doing clinical trials as well, but it's patently clear to us, Paul, that the revenue range that – that we're talking about here is fully supportable. And look, I'll go out on a limb a little bit to say that, you know, with a little more time, my sense is we're going to be increasing the high end of that range. Too early to do that today on this call, but at least looking at the revenue track from our approved customers, They are rocking. I mean, they're buying lots of media, and we know that most of that's going to the approved therapies for production. The remainder going to the clinical trial candidates that they're also using our media in. So, Troy, why don't you speak to our conference about replacing that COVID storage contract with non-COVID revenue for storage, okay?
spk10: Yeah, exactly. So, thanks for the question, Paul. As mentioned before, we have built out that infrastructure. A lot of that infrastructure was using the sterling freezers and the reminder that goes from negative 20 C to negative 80 C, which is the perfect temperature range to store other therapies. So really it's about replacing that COVID contracts with other therapies and modalities. And as I mentioned in my remarks, the big contract we have in the Netherlands that extended it into 2023 has already been replaced. by a different modality that we're currently storing there. And we expect to expand that capacity, too, with that current modality we're storing now.
spk09: Thanks very much. Congrats on the quarter. Thanks, Paul. Thanks, Paul.
spk08: Your next question comes from the line of Thomas Flayton with Lake Street. Please go ahead.
spk07: Hey, guys. Congrats on the quarter. Mike, just with respect to the supply supply chain constraints, I'm guessing that they're rather different across bioprocessing versus the freezers. I was wondering if you could maybe enumerate those a little bit more for us.
spk04: I'll turn it to Rod to do that. He's much closer. I mean, I obviously know what they are, but he's closer to the details. Go ahead, Rod.
spk05: Yeah, hey, Thomas. So on the media side, self-processing side, really it's about packaging, and that would be bottles and bags from a particular supplier that where they've had some capacity constraints that they've been working through opening a new plant. Anecdotally, it feels like things are loosening up a little bit, may still have a few constraints here as we go through Q4 in this regard, but I think 2023 will really loosen up based on their increased capacity. On the cryogenic freezer side of things, which I mentioned, there's a very specific Constraint as it relates to one vendor who provides us with the critical component for those freezers and as I mentioned we have Have a second source where we've got three products or three components if you will that need to be validated one is completed and we're shipping products in q4 and We're working hard to validate the second one to see if we can get some units out still this quarter. And the third one will be done in Q1, which is obviously the smaller volume one as well. Then in addition, we've got some electronic component constraints. Those are probably more global in nature and more generic. And that also has eased up a bit, but that has created some issues with respect to boards for our ULT freezers. In particular, the board replacement customer service program that we embarked on a couple of quarters back has slowed a little bit just based on the lack of flow and our directing the flow to new products versus customer service.
spk07: Great. If I could switch over to the storage services, I was curious if we could get an update on the facility that was due to open here any time. And then also, as you're thinking about new sites, how do you think about the location of those relative, you know, if you're thinking about manufacturer versus site of service? I saw Allogene, for example, just opened a new Shanghai facility. So how does that factor into the calculus you do to pick sites?
spk04: Thanks, Thomas. Another really good question. The plan of opening another bar repository this calendar year has now been delayed for good reason. We have more inputs now to help us make the best decision, and we're looking at several locations, both here in the U.S. and outside the U.S., and to your point, correlating those to anchor customer sites where they have production facilities where the transport time from their place to our storage facility would be reduced. So we've got a lot of factors that we're thinking about, but For sure, I mean, our plan is to pick the site and get at least one new buyer repository turned up in the next calendar year in 2023. That's not reflective of any diminishment of demand. To the contrary, we just want to slow down a little bit and be a lot more thoughtful in the inputs of that decision to make sure that we've got just a great pick with plenty of scale capacity.
spk07: And then one final one. Any updates for us on the Coriel agreement that you guys struck? I think it was three or four months ago.
spk04: No, nothing noteworthy.
spk09: Got it. I appreciate it. Thanks, guys. Thanks so much.
spk08: Your next question is from the line of Jacob Johnson with Stevens. Please go ahead.
spk03: Hey, good afternoon, everybody, and Rod. I'll echo my congrats on the retirement as long as, like I said, it sticks this time. Maybe first just – yeah, yeah. Just first on the freezer business, I think, as you guys alluded to, there's some talk that maybe the macro backdrops impacting demand for freezers in the near term. It seems where you moderated expectations is more around your own internal supply in the supply chain. So can you just talk about what you're hearing from customers on the freezer side in terms of demand and maybe how should we think about this asset growing longer term?
spk04: Yeah. Hey, Jacob. Mike here. Good question. You know, the demand side, I guess from our perspective, is things are going fine. We have this supply chain constraint that we're talking about. But I will say that, you know, because of the COVID sugar high and all the need to build up COVID infrastructure over the last couple of years, I would not be surprised if we face to some degree, a new competitor, and that would be in the form of resale of used freezers. And that's going to affect everybody who's been selling freezers in that space. But we'll see. No real detriment from that yet, but they're keeping our eye on that. But as far as our book of business on cryo and sterlings across those temperature ranges, we're not seeing some huge erosion to the contrary. It's really more of our ability to produce.
spk03: Okay. That's helpful, Mike. And then just sorry to belabor the point, but going back to to storage services, you know, there's, there's a good amount of COVID in that business. It sounds like you've already transitioned one of the contracts, uh, for kind of non COVID applications, but I think, you know, investors are concerned. Um, do we see that business maybe shrink next year if COVID is rolling off? So, so maybe can you talk about the dynamic of how we should think about those COVID revenues rolling off in the near term, and then your ability to transition that capacity for, for non COVID purposes? maybe particularly as we think about 2023?
spk04: Yeah, we can give some color. And of course, when we issue guidance for the full year 2023, we'll have some more granularity on that platform and some supportive narrative that can help you understand how we got there. But as Troy just mentioned, a big COVID contract has already at least been contractually committed to be replaced, and that's great. So you know, we're going to be reducing our reliance on COVID revenue across the entire portfolio as we get out to the next year and years beyond. Right now, it's down significantly from last year. Next year, it'll be even less. So, you know, it was all fine. We had other companies who enjoyed that, that bonus when it was there. But at least for us, we're not going to be anticipating any reduction in storage services for next year. We're not going to tell you where we're going with it yet, but it's certainly going to have a healthy growth rate applied to it based on just organic growth, but also the replacement of that big, chunky COVID contract.
spk03: Thanks for that, Mike. That's super helpful. Just one quick clarification there. The contract that was amended, the COVID contract that was amended for non-COVID purposes, was there any change in the revenue? Are they still paying the same amount? I guess is the question.
spk04: Yeah, I appreciate you asking too much detail. Yeah, we wouldn't speak to that detail.
spk03: Okay, fair enough. I had to try. Thank you, Mike, and congrats again, Rod.
spk09: Thank you. Your next question is from the line of Max Masucci with Cowan.
spk08: Please go ahead.
spk01: Hi, this is Stephanie on for Max. Thanks for taking my questions, and congrats, Rod, on the retirement. So, a quick one on cell processing. Are there any specific demand trends by customer and market that you can call out within the platform segment? Are you seeing any evidence of slowdown among earlier stage biotech or biopharma customers given recessionary fears?
spk04: Super question, Stephanie. To the contrary, you might recall in my remarks a few minutes ago, the four catalysts that we see driving demand for self-processing are really all about new approvals, additional indications for existing approved therapies, new geographies, and I think most importantly, for the benefit of cancer patients would be getting these therapies moved up in the treatment regimen so you don't have to be really on your last breath having failed systemic chemo two or three times to get a CAR T. You know, it's second line, and I believe clearly within our lifetime, if not in the next couple years, we're going to see first-line therapies. And, you know, the clinical results are stellar. The pharmacoeconomics work to support that kind of spend. So, yeah, no slowdown whatsoever.
spk01: That's great to hear. And another one on storage and blockchain services. So for your partnership with C-FACE, you indicated in that press release that you expect to support 10,000, 12,000 EVO shipments for CGT starting materials and manufacturing doses over the next 12 months. How should we think about that pacing of the increase in shipments over the coming quarters? And is there any seasonality factors that we should keep in mind?
spk04: I would say no to seasonality, Stephanie. It's really about how fast we can onboard and get the CSAFE team trained up and how fast they can, you know, do their thing with their own sales and marketing engine. As far as the run rate, you know, right now it's pretty much every quarter the number of UO shipments are doubled from the quarter of the same period last year or the previous year. So, I mean, with growth of, The currently approved therapies and all the catalysts I just mentioned a minute ago, those will be the modulators that time out in terms of how fast we get there.
spk01: Great, that's helpful. And one last one from me. So some of your tools and manufacturing peers have indicated that customers are working through access inventories and normalization and are seeing a normalization in ordering versus bulk annual orders. Have you seen any similar behavior to ordering trends with your customer base? And if so, could you specify on the product?
spk04: Yeah, just one to the contrary. So in our most recent quarter reported Q3, one of our largest distributors ordered quite a bit more than the previous quarter. And, you know, they have a healthy discount. So that customer mix obviously has a bit of a gross margin impact. But no, to the contrary, not anything about reduced orders or burning through safety stocks or anything like that. If anything, on the media side, I mean, this is the business that's going to keep on giving. We're embedded in so many customers and particularly these large global pharma companies who have CGT operations, either de novo or acquired. And yeah, this thing is going to rock for quite a while here. You might have heard me say in the prepared remarks that, you know, just using a modest kind of low 30% annual growth rate, media alone we think can get to $250 million in revenue over five years, just as that one part of the business, not total revenue, but just preservation media.
spk01: Got it. That's helpful. Thanks again for taking my questions, and congrats.
spk04: You're welcome. Thank you.
spk08: Your next question is from the line of Yuanzi with B. Reilly Securities. Please go ahead.
spk02: Mike, thank you for taking our questions, and congratulations on a strong culture in this tough microenvironment. And Rod, surely we will miss you there. So here I have a couple of questions. First, glad to see the new partnership with C-Safe. Maybe follow up there. Can you remind us how does C-Safe fit in your offering right now? in the context of that you already have other courier partnerships in place, and now with CSAFE, within cryogenic logistics, what can you together offer to cell and gene therapy companies?
spk04: Yeah, good place to start, Yuan. Thanks. So, you know, CSAFE is a really well-managed company. They've got some great relationships in CGT. This is really at its base just the extension of the EVO partner network. So customers obviously have a lot of optionality. They can access the EVO platform through a number of couriers, all the major couriers. You know, CSAFE has obviously really strong aspirations to be a much, a more dominant supplier of these critical services to the CGT space, and we're glad to have them in the network for sure. So I think we're going to certainly see some productivity from that team once they're trained up, and they'll be competing against particular shipment opportunities against the other couriers, but really, really good for them and obviously good for customers to have broad access and ultimately really good for BioLife. So we've got just a force multiplier in the form of our partnership with C-SAFE.
spk02: Got it. And maybe a follow-up there. So what can CCF bring to your table to kind of strengthen your current position in terms of offerings to customers?
spk04: I think, Yvonne, we're going to have to watch and see... how they do with the current regime of single shipment of autologous therapies, clearly because they're in the big shipper container game as well, they're going to be able to offer the allogeneic space, lots of flexibility and really tight temperature regulated storage of pallet size containers and both active and passively controlled containers. So my sense is you know, we're going to start out with them, see how they do, give them great stellar support, and ultimately their end customers as well, many of whom we already know and many of which are already using our media or other parts of our solution. So really, really, this is, to use my term of a minute ago, this is another force multiplier here so we can have even more expanded, you know, exposure to the CGC space through one other highly regarded, highly trusted service provider.
spk02: Yeah, that's good to hear. And maybe one last question on the CC partnership. So, as you know, it requires regulatory inspections or filings to have these two platforms integrated together. So, maybe can you comment on how long does this process will take and when will customers have these options available to them?
spk04: Oh, yeah, sure. Well, you know, as far as a customer and their own regulatory updates, of naming a courier in an IND or a BLA. I'm not so sure that's really how it goes, Yuan. I think that it's more of a generic description that, you know, the final manufactured dose shall be transported in the vapor phase of liquid nitrogen to the final destination. My sense is not that they're naming Cryoport or they're naming World Courier or any third parties like that with that degree of specificity, so I don't really think that's going to be a necessity, unless you know something that I don't, but that's not our sense of how that particular documentation would go and with regard to your last question about you know when we might be able to speak to how productive the sea safe relationship is well what they need to get going you know they need to obviously finish the training and we need to do a lot of support with them but my sense is over the next couple of quarters or so we'll start to see them kick in and we're glad to have them in the party with us in the boat yeah got it and maybe one last quick one for Troy can you clarify what's the percentage of your revenue
spk02: coming from ex-U.S. versus, you know, the domestic.
spk10: Yuan, yeah, that's in the 10Q, and I believe it's 80% is U.S. and 20% ex-U.S.
spk09: Got it.
spk02: That's all from us.
spk09: Thank you for taking our questions. You're welcome.
spk08: Your next question is from the line of Siraj Khalia with Oppenheimer. Please go ahead.
spk11: Good afternoon. Thank you for taking my questions. And Rod, let me echo the sentiment. It has been a pleasure dealing with you over the last, what, almost 15 years. So wish you a healthy and safe retirement. Hey, Mike, a lot of my questions have been asked. So I'll just stick to two. Mike, your comments about everything is rocking and rolling and the 30% CAGR is maybe if you could just provide us one additional layer, i.e., you know, all the new customers that are being added. Mike, how much time from the point that they are added to when these customers start having somewhat of a material impact in the respective line items? That would be one of my questions. And Mike, to your other point on $250 million by 2020, 2024, maybe if you could just help us understand, is it organic or is it, are there any implicit acquisitions also baked in? Gentlemen, thank you for taking my questions, and Rod, congrats again.
spk04: Thanks, Siraj. Hey, Siraj, Mike here. Yeah, good questions. I'll take the second one first. No, no other anticipated or additional M&A required to get us to that ending Q4 2024 run rate of total revenue. Now, with respect to the customer revenue journey, I can say the longest ramp would be on the preservation media, just based on their own timeline to get something from a preclinical state through the various phases of clinical trials to a regulatory approval. And that can take, as you know, anywhere from know just three to five years or so now that's probably going to get compressed over time as the regulators become more familiar with these constructs right and the clinical data hopefully is sustained and these stellar results and all that kind of stuff so it really it does it does vary by the product or by the service platform but that's that's probably there a reasonable sort of estimate I guess the point I'd like to just close on that is to wrap it is that you know most of the preservation media revenue comes from existing customers that have approved therapies. And over time, you know, you could just see that as additional therapies make it over the goal line and the other three catalysts that I described earlier in the call, you know, new indications for existing therapies, new geographies for existingly approved therapies, and then finally getting the stuff moved up in the treatment regimen. This is just going to cascade. There will be several of these catalysts that stack up on each other every quarter and then year over year here, all of which we believe is easily going to support you know, my comment a minute ago of just media alone growing modestly, and I say modestly relative a lot of other tools and services, but modestly at 30 plus percent annually, getting the $250 million in revenue of super high margin, recurring, very sticky, written into BLA kind of revenue. So that's just one part of the business, but really encouraging.
spk00: Thank you.
spk09: At this time, there are no further questions.
spk08: I will now turn the call over to Mr. Rice for any closing remarks.
spk04: Thanks, Dennis. Thanks again, everyone, for your interest in BioLife. Have a great evening and the rest of the week. We'd like to wish you and your families a safe and joyful holiday season that's coming up here, and we look forward to seeing many of you at the J.P. Morgan Conference in January. Good night.
spk08: Thank you all for joining the BioLife Solutions shareholder and analyst conference call. We thank you for your participation. You may now disconnect.
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