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spk02: Thank you for standing by, and welcome to Technova's fourth quarter and four-year 2022 financial results call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. I would now like to hand the call over to Senior Vice President of Marketing, Jen Henry. Please go ahead.
spk04: Thank you, Operator. Welcome to Technova's fourth quarter and full year 2022 earnings conference call. With me on today's call are Stephen Gunstream, Technova's President and Chief Executive Officer, and Matt Lowell, Technova's Chief Financial Officer, who will make prepared remarks and then take your questions. As a reminder, the forward-looking statements that we make during this call, including those regarding business goals and the expectations for the financial performance of the company, are subject to risks and uncertainties that may cause actual events or results to differ. Additional information concerning these risk factors is included in the press release the company issued earlier today, and they are more fully described in the company's various filings with the SEC. Today's comments reflect the company's current views, which could change as a result of new information, future events, or other factors. and the company does not obligate or commit itself to update its forward-looking statements except as required by law. The company's management believes that, in addition to GAAP results, non-GAAP financial measures can provide meaningful insight when evaluating the company's financial performance and the effectiveness of its business strategies. During this call, we will therefore use non-GAAP financial measures of certain of our results. Reconciliations of GAAP to non-GAAP financial measures are included in the press release that we issued this afternoon, which is posted to Technova's website and at www.sec.gov. Non-GAAP financial measures should always be considered only as a supplement to, and not as a substitute for, or as superior to, financial measures prepared in accordance with GAAP. These non-GAAP financial measures in this presentation may differ from similarly named non-GAAP financial measures used by other companies. Please also be advised that the company has posted a supplemental slide deck to accompany today's prepared remarks. It can be accessed on the investor relations section of Technova's website and on today's webcast. And now I will turn the call over to Stephen.
spk05: Thank you, Jen. Good afternoon and thank you everyone for joining us for our fourth quarter and full year 2022 earnings call. Technova is a leading producer of critical reagents for the life sciences industry to accelerate the introduction of novel therapies, vaccines, and molecular diagnostics that will help people live longer, healthier lives. We manufacture high quality customer agents with short turnaround times and are positioned to scale with our customers as they advance their products from discovery to commercialization. In 2021, we presented a strategy to position the company for sustainable accelerated growth through investments in capacity expansion, commercial excellence, and scientific innovation. I'm pleased to report that we are effectively executing to that plan. First, our new state-of-the-art modular manufacturing facility became operational at the end of 2022 for research grade production and is on track for GMP production by mid-2023. In addition, we've modernized our supporting infrastructure to scale the business for years to come, including a new ERP system, an updated quality system, and the introduction of highly automated reagent manufacturing equipment. We believe these investments, plus our existing infrastructure, will give us the capacity to deliver approximately $200 million in annual product revenue when fully utilized. Second, In 2020, I hired the first two dedicated field sales representatives at Technova in what was the beginning of our commercial investment. I'm pleased to report we are now fully operational from a commercial and marketing perspective, including implementation of backend systems and processes such as Salesforce.com, automated marketing, and an e-commerce engine. Sales and marketing associates have been onboarded and are already driving demand for custom and GMP-grade reagents. Early indicators demonstrate our ability to move our catalog customers into our custom and clinical solutions products. Today, more than 76% of our annual revenue is generated from customers who purchase custom and or GMP-grade reagents, compared to 68% in 2020. Of those, 56 of our approximately 100 cell and gene therapy accounts now purchase custom and or GMP-grade reagents, compared to 32 in 2020. These cell and gene therapy customers today represent approximately 25% of our annual revenue. Lastly, on the R&D front, we have made great progress advancing our new product pipeline. In Q4, we introduced an early access program for two novel products intended to streamline downstream gene therapy process development, and we now have several customers enrolled in that program. On a related note, today we announced a collaboration arrangement with Sartorius via Separations, which is part of the international life science group Sartorius to help our customers improve their AAV purification processes with one of our early access products. Matt will provide specific comments on our guidance, but I want to give an update on some of the trends we continue to see in the market and some thoughts on what we are anticipating in 2023. With the certification of our new facility to produce GMP grade reagents anticipated in the middle of this year, and the recent strategic investments we have made to expand our commercial and marketing teams, we believe we are well positioned for future growth. For the next several quarters, however, we anticipate continued headwinds associated with limited demand from early-stage biopharma customers, which we expect to be partially offset by growth in other markets. Nevertheless, we remain optimistic about the long-term potential of early-stage biopharma. We continue to engage with these customers, including with those who have deferred orders, while establishing a strong pipeline of opportunities that we believe may begin to generate additional revenue in mid to late 2023. I will now hand the call over to Matt for a discussion of the financials.
spk06: Thanks, Stephen, and good afternoon, everyone. Results for the fourth quarter of 2022 were lower than prior year, as anticipated, given challenges in the markets. However, we delivered solid results for the full year of 2022. Total revenue was $7.9 million for the fourth quarter of 2022 and $41.4 million for the full year. Revenue for the fourth quarter of 2022 was $7.9 million, an 18% decline from $9.6 million in the fourth quarter of 2021, and $41.4 million for the full year of 2022, a 17% increase from $35.4 million for the year 2021, excluding sample transport. A way of reminder, Technova launched the sample transport product in the latter part of 2020 to address the urgent need for COVID-19 tests and we no longer market or manufacture the product. Lab Essentials products are targeted at the research use only or RUO market and include both catalog and custom products. Lab Essentials revenue was 7.0 million in the fourth quarter a 3% increase from $6.7 million in the fourth quarter of 2021. For the full year, Lab Essentials revenue was $31.8 million, a 17% increase from $27.2 million for the full year 2021. Growth for the full year was driven by a 3% increase in the average revenue per active customer to $7,714, and a 13% increase in the number of active customers to 4,121. Clinical solutions products are made according to good manufacturing practices, or GMP, quality standards, and are primarily used by our customers as components or inputs in the development and manufacture of diagnostic and therapeutic products. Clinical Solutions revenue was $0.8 million in the fourth quarter, a 68% decrease from $2.4 million in the fourth quarter of 2021. For the full year, Clinical Solutions revenue was $8.4 million, a 24% increase from $6.8 million for the full year 2021. We grew our clinical solutions revenue by adding new active customers, growing from 22 customers in 2021 to 27 in 2022. Average revenue per active customer in 2022 increased 1% to $313,000. We expect revenue per customer to increase over time as they ramp up their purchase volumes. However, this metric can be affected by the mix of newer clinical customers who typically order less. Just as a reminder, due to the larger average orders in clinical solutions compared to lab essentials, there can be quarter-to-quarter revenue lumpiness in this category. On to the income statement. Gross profit for the fourth quarter of 2022 was $2.1 million compared to $5.0 million in the fourth quarter of 2021. And $17.5 million for the full year 2022 compared to $17.6 million for the full year 2021. Gross margin was 26.7% of revenue in the fourth quarter 2022, which is down from 49.2% of revenue in the fourth quarter of 2021, and 42.2% for the full year 2022, which is down from 47.8% for the full year 2021. Additional headcount resulted in higher labor costs, which primarily drove the decline in gross margin in both the fourth quarter and full year of 2022. Lower revenue also significantly impacted the fourth quarter of 2022. Operating expenses for the fourth quarter of 2022 were $16.3 million compared to $9.7 million for the fourth quarter of 2021. and $67.1 million for the full year 2022 compared to $29.6 million for the full year 2021. Operating expenses for the fourth quarter 2022 increased primarily due to a $4.2 million one-time non-cash impairment charge related to long-lived assets recorded during the fourth quarter of 2022. as well as to additional headcount stock-based compensation expense and marketing costs. Operating expenses for the full year 2022 increased primarily due to one-time non-cash charges, including a $16.6 million goodwill impairment charge recorded during the third quarter of 2022, a $4.2 million impairment charge related through long-lived assets recorded during the fourth quarter of 2022. Ongoing operating costs were up as well due to additional headcount, stock-based compensation expense, and marketing costs. In the fourth quarter, 2022, the company decided to cease further use and development of certain manufacturing machinery and equipment primarily related to serving a segment of the market we no longer considered attractive as we completed our 2023 budgeting process and finalized the capabilities best suited for our new facility. The company therefore reviewed the recoverability of the carrying value of these assets and as a result recorded a one-time non-cash impairment charge of $4.2 million related to these long-lived assets. Net loss for the fourth quarter 2022 was $13.3 million, or 47 cents per diluted share, compared to a net loss of $3.6 million, or 13 cents per diluted share, for the fourth quarter 2021. Net loss for the full year 2022 was $47.5 million, or $1.69 per diluted share, compared to a net loss of $9.8 million, or 61 cents per diluted share for the full year 2021. Adjusted EBITDA, a non-GAAP measure, was negative 8.1 million for the fourth quarter 2022, compared to negative 3.4 million for the fourth quarter 2021. Adjusted EBITDA for the full year 2022 was negative 21.9 million compared to negative 7.6 million for the full year 2021. On to cash flow and balance sheet highlights. Capital expenditures for the fourth quarter of 2022 were 4.7 million compared to 7.4 million for the fourth quarter of 2021. capital expenditures for the full year 2022 were $28.1 million compared to $19.9 million for the full year 2021. The majority of spend in the fourth quarter 2022 went towards completing construction of our new production facility. We do not expect to make the same level of capital expenditure in 2023 now that construction of the new production facility is substantially complete, although there are still some moderate investments associated with qualification of the facility to produce GMP-grade products. Pre-cash flow, a non-GAAP measure, which we define as cash provided by or used in operating activities, less purchases of property, plant, and equipment, was negative $12.8 million for the fourth quarter of 2022 compared to negative 10.5 million for the fourth quarter 2021. Free cash flow for the full year 2022 was negative 55.5 million compared to 28.9 million for the full year 2021. This decrease compared to the prior year period was primarily due to higher cash used in operating activities for both the fourth quarter and full year 2022 and a significant increase in capital expenditures for the full year 2022. Turning to the balance sheet, as of December 31st, 2022, we had $42.2 million in cash and cash equivalents and $22.1 million in gross debt. Onto our 2023 outlook. We are providing 2023 total revenue guidance of $42 million to $46 million. At the midpoint, this assumes a revenue growth forecast of approximately 6% as compared to 2022. With respect to product categories, we expect Lab Essentials revenue to be roughly flat compared to 2022. and clinical solutions revenue to grow between 20 to 50% compared to 2022. This product category growth guidance includes the assumption that a significant customer will shift from lab essentials to clinical solutions products in 2023. We are completing a planned two-year period of strategic investment that we believe has prepared our business to scale commercially and operationally over the next five years. In response to the slowdown in revenue seen since the third quarter of 2022, we have enacted several measures to contain costs. Notably, in February 2023, we completed a reduction in force that affected approximately 13% of our workforce and resulted in one-time costs in the first quarter 2023 related to severance of approximately $0.8 million. The reduction will generate approximately $4 million, $4.0 million in annualized savings, We anticipate significantly lower capital expenditures and flat operating expenses going into 2023 when compared to what we reported for the full year of 2022, excluding non-recurring charges. We are committed to creating value for shareholders through strategic capital allocation that balances investment for future growth while also ensuring a path to profitability. Therefore, we are targeting free cash flow of approximately negative $30 million for 2023. In addition to cash on hand, we have additional funds available under our credit facility. In sum, we are comfortable that our liquidity position allows us to make investments needed to execute our growth strategy. With that, I will turn the call back to Stephen.
spk05: Thanks, Matt. Overall, we were pleased with our fourth quarter and full year 2022 performance and the progress we made against our strategic priorities. The long-term outlook for our end markets remains positive, and we are committed to executing on our strategy to help our customers accelerate the introduction of novel therapies, diagnostics, and other products that improve human health. We will now take your questions.
spk02: As a reminder, to ask a question, you will need to press star 1 1 on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from the line of Joseph Flanagan of Cowen. Your question, please, Joseph.
spk03: Hey, this is Joe from . Thanks for taking the questions. Just first on clinical solutions, the quarter came down a decent amount year over year, but was similar to what you saw. in Q3, and that 20 to 50% growth guidance is really encouraging ahead of our model, but it's pretty wide range. So I guess first, what is the fact that giving you confidence in the return to growth here in 2023, and what are some of the puts and takes that get us from the low to the high end of this range?
spk05: Okay, thanks, Joe. I'll start, and Matt, feel free to jump in. From a confidence perspective, I think there's really three different aspects here. The first is I think, you know, when we talk to our customers, we're operating in a new normal funding where there has been acceptance of the amount of funding out there and people and customers, I should say, are now working with the funds they have and moving forward. The second piece there is that, you know, as we said in our comments a moment ago, we have now a full commercial marketing organization and we are a very small part of a large opportunity in the space. And we're getting that up and going. And with that, there's about a 12-month cycle from the time that we see customers engage with us and then start migrating and scaling up in terms of their purchases. And so when we look at our funnel, we feel like the back half is where we see that return. Back to that, as you said, the 25% plus for the entire business.
spk06: And I'll just add to that comments, which all are very valid, is that we have this, I mentioned in my remarks, a significant customer that is moving from purchasing lab essentials products to clinical solutions. So we do have that transition happening, which is good for our clinical solutions business and consistent with our strategy of moving customers from catalog to custom to the clinical part of our business, the clinical solutions business. And I would say, you know, to further to what Stephen said, of course, there is some dependency on timing of when these clinical orders that we're anticipating coming in that will sort of give us, you know, in the back half of the year in particular, some variation of what we might expect due to those lumpy larger orders. So that's some reasoning behind the range that we provided. But we do feel good about that business going into 2023.
spk03: Great, and great to hear about the funding environment picking up. I was just curious if you could quantify or maybe roughly quantify the amount of the larger deferrals you've seen in the last two quarters and like how much of that could really trickle into the back half versus more of a 2024 thing.
spk05: Yeah, we aren't going to pull out the exact numbers and things like that, but what I can say is that if you remember our Q3 call, We had a very strong first half of 2022, and then we guided down for the back half when we started seeing some of these deferrals and push-outs of some of these customers. And I do think that many of those were actually reducing the number of therapies and pipelines, as well as size of those. I think that has primarily now been, like I said, is really kind of the new norm for funding for many of these customers. But the cell and gene therapy space in particular continues to be a very exciting area and an area of investment. And so at the moment right now, I think that it's not so much deferral as this is the new norm and we're going to build from here.
spk03: Got it. Thanks for taking the questions.
spk02: Thank you. Thank you. Our next question comes from the line of Matt LaRue of William Blair. Your line is open, Matt.
spk01: Hey, good afternoon. Could you give us a sense for maybe what you would be seeing for lab essentials growth excluding the customer shifting and then with that outlook, are there any sort of first half or second half dynamics? You referenced sort of conservative customers. Is that embedded in your outlook? It seems to be a bit lighter than both obviously your historicals, but even what others in the space have characterized.
spk06: And you're referring specifically to the lab essentials piece, Matt?
spk01: That's right, Matt, yep.
spk06: Yeah, good. Yeah, thanks for the question. Yeah, I think with respect to what the growth rate would look like for the lab essentials without that customer, we're not giving exact numbers related to that specific customer, obviously, but I think you would see a more normalized growth rate in the lab essentials with that. Of course, I would just say in general, in 2023, we are having some more tough comparisons compared to 2022. given the level of activity that we saw in particular in the first half of the year. So I think, you know, on a kind of adjusted basis for that difficult comp, the lab essentials would look fairly in line with historical norms on that basis.
spk05: Just add a little color here, Matt. you know, many of those customers, you know, they vibrate from catalog to custom to clinical, and so some of those custom lumpiness is in that historical number.
spk01: Okay, and then just thinking about, you know, you referenced the OPEX, obviously. I've been flat year over year. On the gross margin side, I think sort of competing factors given, you know, increased weighting towards clinical solutions, which should help, but Obviously, you're now moving capacity and volume into the new facility that you brought online. So fourth quarter, I think, was lighter than we would have thought it would be. So can you just maybe give us some sense for how you expect gross margin to evolve throughout the year?
spk06: Yeah, sure. I'll be happy to take that one. For sure, as you mentioned, Matt, gross margin is going to be significantly impacted by the result of opening the new facility now. As a reminder, we spent close to $40 million on that facility over the last two years, and we are starting to roll those costs out through depreciation into the P&L. Some of those costs started in the fourth quarter of last year. Others will be coming on during the course of this year. So based on that fact and the updated outlook that we're providing here today for 2023 revenue, I would say I would expect our gross margins to be in the low 30s for the year, that kind of range. And as you might expect, seeing improvement in the second half of the year versus the first half of the year, and particularly as the revenue picture improves in the second part of the year.
spk01: Okay. Thanks, Matt.
spk02: Thank you. Our next question comes from Jacob Johnson of Stevens. Your question, please, Jacob.
spk00: Hey, this is Hannah on for Jacob. Thanks for taking the question. Could you just talk about how you'll balance taking costs out of the business and with continuing to invest in growth in the business?
spk05: Yeah, sure, Hannah. Obviously, as we look at this, we manage our costs to make sure that we have our path that we need forward to drive the growth long-term. So everything here is a balance. And so what we've done is we've reduced our costs to make sure that we manage our capital, but at the same time, we're not sacrificing any of the long-term growth aspects. And you can see through what we did in 2022 and what our strategy is for 2023 to scale the business, we're not cutting back in those areas. to make sure we put ourselves in a position for high growth going forward.
spk06: Yeah, I'll just add, since I made some comments about the reduction in force that we had in February last month, that as we went through that process, we were very careful to look at where we have invested and where we expect the returns on those investments to be. Naturally, affecting as little as possible those areas that will be providing the return, like in sales and marketing and research and development. So we did take actions there to cut across generally across the board, but in those areas we made minimal changes and looked where we could afford to cut back in other areas to achieve exactly what you said there, Hannah, which is the the balance of maintaining future growth and investment to do that versus cost savings.
spk00: Great. And can you just talk about how customer interest has been in the new facility now that it's up and running? Are there any leading indicators to point to in terms of demand there?
spk05: Sure. So the new facility, just so everyone understands, the new facility is up for production for research-grade material. And then our efforts right now are really around getting it certified to manufacture TMP products. And that is actually a significant effort. And many of these larger clinical solutions customers would want their product manufactured in this new facility. So for us, the timing of getting that done is when they start coming in to do their audit for that facility. That said, I do think that there's definite interest, and part of our commercial strategy is to be engaging with these customers, letting them know that that's coming, and when necessary or desired, to have them on site. And I think the handful of customers that have been on site and seen the facility are extremely encouraged, and they recognize that this is a company that they can work with to go all the way through their clinical trials through commercialization.
spk00: Great. Thanks. I'll leave it there.
spk02: Thank you. At this time, I'd like to turn the call back over to Stephen Gunstream for closing remarks. Sir?
spk05: Great. Thank you, and thank you for joining us for our 2022 full-year earnings call. We look forward to connecting with you at the next investor conference.
spk02: This concludes today's conference call. Thank you for participating. You may now disconnect.
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