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spk03: My name is John and I'll be your conference operator for today. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Mike Pollier of Head of Investor Relations. Please go ahead.
spk09: Good morning, and thank you for joining the Rapid Microbio Systems first quarter 2024 earnings call. Joining me on the call are Rob Spignessi, President and Chief Executive Officer, and Sean Wurchis, Chief Financial Officer. Earlier today, we issued a press release announcing our first quarter 2024 financial results. A copy of the release is available on the company's website at rapidmicrobio.com under Investors in the News and Events section. Before we begin, I'd like to remind you that many statements made during this call may be considered forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements, including but not limited to statements relating to Rapid Micro's financial condition, anticipated future cash usage and cash runway, guidance for 2024 including revenues, expenses, gross margins, system placements, and validation activities, expectations for and planned activities related to the company's business development and growth, customer interest and adoption of the growth direct system, statements regarding the planned launch and commercialization of rapid sterility, and the potential impact of macroeconomic uncertainty on Rapid Micro's business. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. For a list and description of these risks and uncertainties associated with Rapid Micro's business, please refer to the risk factors section of our most recent annual report on Form 10-K filed with the Securities and Exchange Commission as updated from time to time in our subsequent filings with the SEC. We urge you to consider these factors and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 3rd, 2024. Rapid Micro disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll now turn the call over to Rob.
spk05: Thank you, Mike. Good morning, everyone, and thank you for joining us. I will begin this morning's call with an overview of our first quarter performance and highlights, followed by a review of our priorities for 2024. I will then turn the call over to Sean for a more detailed review of our financial results and outlook. First quarter total revenue increased 11 percent to $5.6 million compared to the first quarter of 2023. This performance is ahead of the guidance we provided in March and represents the sixth quarter in a row that our revenue exceeded guidance. We placed three growth direct systems in the quarter, all to existing customers. First quarter recurring revenue increased 15% compared to Q1, 2023, and has now grown by double digits in each of the 11 quarters since we became a public company. Consumable sales, which are part of recurring revenue, increased 22% year over year and achieved a new quarterly record exceeding our prior record set in the second quarter of 2023. This strength in consumables demonstrates that customers are actively using their growth direct systems and are realizing value across their global manufacturing networks. In total, our first quarter results reflect a solid start to 2024, and we are reaffirming our full year 2024 revenue guidance of at least $27 million. representing at least 20% growth and at least 20 system placements. We continue to execute against our strategic priorities of accelerating system placements, improving gross margins, commercializing innovative new products, and prudently managing our cash. I'd like to provide a brief update and context for these priorities. Over the past few months, I visited with customers across North America and Europe. These meetings are always productive, and I would like to provide some recent customer feedback. The GrowthDirect value proposition is resonating, and customers are realizing meaningful benefits. They continue to plan further deployment of GrowthDirect systems across their global manufacturing networks. The many benefits of the GrowthDirect's full automation include enhanced data integrity, improved accuracy, reduced human error, and lower hands-on labor costs. In addition, the Growth Direct offers operational efficiencies which can enable faster product release, less waste, and reduced inventories. Moreover, given the clear demand in the industry for increased manufacturing capacity, the Growth Direct's speed and efficiency provide critical flexibility to manufacturing and quality control operations and can enable customers to unlock additional production capacity. Importantly, These operational efficiencies, which are ideally suited for the advanced modalities of biologics and cell and gene therapies, are also effective for other segments such as vaccines, sterile injectables, and small molecule manufacturing. The pace of growth in advanced modalities and the need for improved data integrity industry-wide is accelerating the adoption of automation. As customers implement automation across their manufacturing networks, we are confident that the growth direct is an important part of the solution. We continue to expect an acceleration in system placements in the second half of the year. Our confidence is underpinned by the size and quality of our sales funnel, a fully staffed global sales team, and visibility into growth direct purchases from our customers' senior level executives. Turning to our next priority, which is improving gross margins, We expect to continue to benefit from our initiatives focused on product cost reduction, manufacturing efficiency, and service productivity improvements. We remain on track for an inflection to positive gross margins in the second half of the year. Next, we look forward to the successful launch and commercialization of rapid sterility. Since our announcement earlier this year, customer interest for this breakthrough technology has been growing and has exceeded our expectations. Our commercial teams are trained, and we are completing the technology transfer from R&D and into manufacturing with the associated scale-up activities. In June, we are hosting customers at our Lexington Innovation Center and Demonstration Lab for a live, hands-on experience with the GrowthDirect Rapid Sterility Platform. We remain on schedule for a mid-2024 launch and look forward to providing an update on our second quarter earnings call in early August. Turning to cash management, we are focused on reducing our cash burn by totally controlling operating expenses, capital expenditures, and working capital. So, to summarize our key messages from the first quarter, it was a solid start to 2024, including a record quarter in consumable revenue. The growth directive providing a strong value proposition by delivering full automation, operational efficiencies, and improved data integrity. Customers continue to plan further deployment of growth-direct systems across our global manufacturing networks. Early customer interest in rapid sterility is strong, and we are on schedule for a mid-year launch. Wrapping up my prepared remarks, I remain excited about our long-term outlook. We have a world-class customer base consisting of 70% of the top 20 global pharma companies, a proven technology with a strong value proposition that is embedded in customer workflows. an attractive high-growth business model with durable recurring revenue. And we are focused on our path to profitability and expect our cost, efficiency, and productivity initiatives to lead to positive gross margins in the second half of 2024 with continued improvement thereafter. And with that, I'll now turn the call over to Sean to discuss our first quarter performance and our outlook in more detail. Sean?
spk10: Thanks, Rob, and good morning, everyone. I'll start my comments today with a review of our first quarter results and then discuss our second quarter and full year 2024 outlook. Q1 revenue increased 11% to $5.6 million compared to $5 million in Q1 2023. During the first quarter, we placed three growth direct systems compared to three in the first quarter last year. We also completed three validations in the quarter compared to two in the first quarter last year. Product revenue, which is comprised of systems and consumables, increased 12% to $3.7 million in the quarter, compared to $3.3 million in Q1 last year. The growth in product revenue was primarily driven by a record quarter in consumables as a result of continued growth in validated systems, as well as several shipments made during Q1 that were originally expected in Q2. Service revenue increased 11% to $1.9 million in the first quarter. compared to $1.7 million in Q1 last year. Service revenue growth was impacted in Q1 by some planned validation revenue that shifted into early Q2. The increase compared to the prior year quarter was primarily driven by a higher level of validation activity as well as higher revenue from service contracts due to the increase in the number of validated growth direct systems. First quarter recurring revenue, which consists of consumables and annual service contracts, increased 15% to $3.7 million, compared to $3.3 million in Q1 last year. Non-recurring revenue, which is comprised mainly of systems and validation revenue, was $1.9 million in Q1, compared to $1.8 million in the prior year quarter. Turning to gross margins, product margins were negative $1.5 million in Q1 compared to negative $1.7 million in the first quarter last year. As we expected and as typical for our business, Q1 product margins stepped down from Q4 2023, mainly due to lower system placements and revenue. Compared to Q1 last year, the improvement was attributable to continued benefits from actions we've taken to lower product costs and increase manufacturing efficiency. These benefits were partially offset by some customer site readiness delays, which shifted $0.2 million in high margin LIM software revenue from Q1 into Q2, an unfavorable product mix due to the higher proportion of consumable revenue in Q1 this year. Service margins were slightly negative in the first quarter, largely due to non-recurring expenses. This compares to negative $0.1 million in the first quarter last year. On a combined basis, Our first quarter gross margin was negative $1.5 million or negative 27% compared to negative $1.8 million or negative 36% in Q1 last year. We continue to expect our Q1 gross margins to be the lowest of the year. We then expect meaningful improvement as we work our way through the remaining quarters as volumes and revenue increase, and we continue to make progress on our initiatives focused on product cost reduction and manufacturing efficiency as well as service productivity. Continuing down the P&L, total operating expenses were $12.8 million in the first quarter compared to $13.1 million in the prior year quarter, a reduction of approximately 3% versus the prior year period. R&D expenses were $3.8 million in Q1, an increase of 22% versus the prior year period, largely due to activities associated with the upcoming launch of rapid sterility. Sales and marketing expenses were $3.3 million, and G&A expenses were $5.6 million in the first quarter, representing a combined 10% reduction versus the prior year quarter as we tightly control spending in the business. Net loss was $13.3 million in Q1. This compares to a net loss of $13.9 million in Q1 last year. Net loss per share was $0.31 in Q1 compared to net loss per share of $0.32 in the prior year quarter. With respect to non-cash expenses and capital expenditures, depreciation and amortization expenses were $0.8 million, stock compensation expense was $1.1 million, and capital expenditures were $0.6 million in the first quarter. We ended the first quarter with approximately $80 million of cash and investments on our balance sheet. I'll now turn to our Q2 and full year 2024 outlook. We continue to expect total revenue of at least $27 million for the full year 2024, which assumes that we will place at least 20 systems. This implies year-over-year revenue growth of at least 20%. This guidance continues to reflect some uncertainty related to the timing and scale of customer purchase decisions. For the second quarter, we expect total revenue of at least $6 million, which assumes at least four system placements. We then expect revenue emplacements to increase sequentially in Q3 and peak in Q4, consistent with our typical annual cadence and the guidance we provided in March. Looking at consumables, we expect revenue to decrease sequentially in Q2 compared to Q1 due primarily to the timing of customer orders and shipments. We then expect consumable revenue to increase sequentially in Q3 and then again in Q4 as mortgage systems complete validation and enter routine use. With respect to service, we expect revenues to be between $2 million and $2.5 million each quarter over the balance of the year, with variability within this range primarily driven by the timing of validation activities. We are reaffirming our guidance of at least 16 validations in 2024, including at least four in the second quarter. Turning to gross margins, we expect meaningful sequential improvement in the second quarter compared to the first quarter, but we still expect Q2 margins to be negative. Thereafter, we continue to expect positive gross margins in both Q3 and Q4, as well as for the full year. We expect product margins to improve each quarter based on ongoing cost reduction and manufacturing efficiency initiatives, as well as increasing volume, but remain negative. We expect double-digit positive service margins in each of the remaining three quarters of the year based on higher revenue and improved productivity. Looking forward, we remain confident in our ability to meaningfully improve our gross margins in 2024 and beyond as we continue to grow revenue, reduce product costs, drive higher manufacturing efficiency, control manufacturing overhead costs, and increase service productivity. We continue to expect operating expenses to be in a range of $48 million to $52 million in 2024, with depreciation and amortization expense of approximately $3 million stock compensation expense of approximately $5 million, capex of approximately $3 million, and other income, which is comprised primarily of interest income, of approximately $4 million. Finally, we continue to expect cash burn of roughly $40 million for the full year 2024. Looking out further, Our goal is to reduce cash burn meaningfully over each of the next several years as we drive towards profitability through a combination of revenue growth, margin improvement, and management of our OpEx, CapEx, and working capital. This supports our expectation that our existing cash and investments provide us with runway at least into the second half of 2026. That concludes my comments, so at this point, we'll open the call up for questions.
spk02: Operator?
spk03: At this time, if you would like to ask a question, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again. We'll pause for just a moment to compile the Q&A roster. The first question comes from the line of Tejas Savan from Morgan Stanley. Please go ahead.
spk06: Good morning. This is Yuko on the call for Tejas for taking a question. Some of your peers have been seeing worsening budget pressure leading to further elongation of sales cycles. Could you elaborate on whether you're seeing a similar dynamic? And what's your take on the customer sentiment with respect to large CapEx purchases?
spk05: Hey, Yuko. It's Rob. So our view and experience with customer budgets is different. similar to previous quarters. So, what we're seeing is, I'd say, continued budget scrutiny with regard to CapEx purchases, and ours, at least for the quality control labs, is on the larger end. So, it can pick up the second part of your question as well. So, no meaningfully different changes in over the past few quarters. But we have seen, I would say, more scrutiny. There's more cycles with regard to approval processes, a bit slower to get to an answer as well. That being said, we're executing through it. Moreover, another important dynamic to understand with rapid microbiome systems is the growth direct, in many cases, is considered a strategic project and program that impacts multiple sites around a customer's global manufacturing network. So while that doesn't insulate us from these dynamics, we have seen notable cases where our projects for growth direct purchases have continued to be prioritized.
spk06: Got it. Thank you for that color. And then a separate follow-up question. With sterility launch expected in the mid-year timeframe, could you elaborate on the remaining to-dos before commercial launch? And then also, is this something that you're actively communicating to your customer, or is it something you're holding until the customer event? If you are actively communicating the upcoming launch already, could you give us a sense for the customer interest you're seeing?
spk05: Yeah, so in reverse order, we have been communicating to customers. We were communicating this at a recent trade show, the PDA annual show, earlier this year, and the interest is, as we expected, quite strong. It reaffirms our belief and our voice of customer work that the market needs a rapid sterility automated system that has what I would call differentiated features from what's available in the market today. That's faster time to detection, much faster time to results, full automation, and the full complement of value proposition that the Growth Direct provides, walk-away, full automation, data integrity. Those, to our view, those features are not available in, I'll call it, other technology-enabled solutions in the market today, and certainly not in the legacy companion manual method, which is still the majority of the market. The first part of your question, the to-dos with regard to the Seriality launch, are the final elements of our development process. to include the transfer to manufacturing. So think of this as the final stages of the R&D process and then the progressive handoff to the manufacturing organizations that will be charged with scaling up the product for commercial release and shipment to customers.
spk01: Great. Thank you very much.
spk02: Thank you.
spk03: The next question comes from the line of Dan Arias from Stiefel. Please go ahead.
spk11: Good morning, guys. Thanks for the questions. Rob, can you maybe just talk a little bit about the confidence that you have in the acceleration of the instrument placement trajectory? I think by the end of the year, you're looking for something higher than where you are, just based on that comment alone. But should we think one to two systems higher, or by the time 4Q rolls around, can you be, you know, I actually have more than double what you did in 1Q, so... Just checking to make sure that you're on a path and that the sales funnel is suggestive of getting more than just a couple of boxes higher so that the full year kind of jives with where we are.
spk05: Yeah, so confidence standing behind our full year guideline of at least 20 system placements and confidence is driven by a number of factors. Sales teams in the field executing globally a fully staffed team. The funnel in particular looks like we want it to look to backstop our guidance to size and composition, the geographic diversity of it, the customer diversity of it. And customers continue to spend a lot of time with customers, and this is where quite a bit of the confidence comes from as well, is customers are increasingly planning, continuing to plan deployments across their manufacturing networks. And increasingly, I'm seeing automation being viewed as a, as a critical strategic priority across customers' networks to include our automation. I mentioned as well, which is helpful for our guide, is we continue to get access to senior level executives at customers. We are becoming more of a strategic A, platform, and B, a larger spend from a practical standpoint in some of these large customers' quality manufacturing operations, and accordingly, we get better access to senior level decision makers. And that's where I spend quite a bit of my time as well. So that provides insight and confidence as well. And the last one would be sterility. I think we've mentioned we're not sort of expecting an enormous impact in the year, but we're serving the right for upside. So a number of these elements are colluding to give us confidence in our guidance you know, notwithstanding the potential impact of Yuko's question of budget scrutiny.
spk11: Yep. Okay. And then maybe on the consumable side, and it might be a question for Sean, but can you just talk a little bit about the consistency of where you are here going forward? In bed with that or within that is a question about the customer that had sold the site, I believe, last quarter, which was impactful. Yep. Can you talk about that this quarter and then whether you're gaining some visibility on what that reacceleration at that one customer might look like?
spk10: Yep, sure. Yeah, so I think this quarter, as we mentioned in the prepared remarks, we did have some things that we expected in Q2 happen in Q1. So the growth that Rob mentioned, 22%, was the highest growth in the business kind of amongst the different product and service lines. And that does reflect a tough comp because of that customer site sale that you mentioned. So we did not have benefit from that in Q1. We clearly did have consumable sales into that site at kind of an ongoing high level in Q1 last year. So that 22% would have been higher if it were not for that challenging comp as a result. So, you know, looking forward, you know, Guided down sequentially in Q2, largely based on the timing of the orders and the shipments of the consumables. So you've seen it the past couple of years. We do have a tendency to bounce around from quarter to quarter. I think more important to look at the annual trends and kind of where things are going in the pull-through. The pull-through was above 80% in the quarter. We talked last quarter about that pull-through for the year looking relatively flat this year, in part because of that site sale last year, part of the way through the year. Through the year, excuse me. So I think with them, we are in touch with them. I do expect we will see some contribution from them more in the second half of the year. I don't think it's going to be particularly close to the level that that site bought at in 2023 or the first half of 2023, but it is a positive sign for us that it feels like things are going in a direction where we'll be coming off the zero and moving up into some revenue contribution from that site in the second half.
spk11: Okay, and just to finish that thought, it feels like if, you know, I know we're still in the first half of 2024, but if I think about 2025, are you okay feeling like we're not going to have to sort of explain away that situation come the beginning of the year and that actually against the comps of this year it can be a tailwind?
spk10: Yeah, I don't see why that would, I mean, if anything, it should be a little bit of a tailwind next year on the comp. So, yeah, I don't think it'll be a negative discussion item in 2025.
spk02: Okay, super. Thank you.
spk03: Thanks, Dan. The next question comes from the line of Steven Ma from TD Collins. Please go ahead.
spk13: Great. Thanks for taking the questions. On rapid sterility on the June demo, can you give us a sense for the interest and types of organizations that are going to be attending?
spk05: Yeah, so we're still compiling all the customers, Steve, but we expect a representation from our current customer base, which leans towards biologics and selling gene therapies, but also customers from other segments such as sterile injectable manufacturing, where we're a bit less represented in our current placement. So the The approach and strategy around sterility is certainly penetration within our current customers, which is significant. As you know, we have the majority of the global top 20. I would say attracting new global top 20 companies that we don't have to include new segments as well. So we do expect a broad array and a diverse group of customers for those events.
spk13: OK, great. Thanks. And then maybe sticking on rabbit sterility, I think you mentioned before in a prior call that there would be a technical presentation at a conference. Was that the trade show that you mentioned?
spk12: It was.
spk13: So, yeah. OK.
spk12: Yeah, we had it. We had it. We had a data published. I'm sorry. Was that data published somewhere or white paper or?
spk05: No, we have some internal documentation that was publicly furnished at the show, but we don't have a formalized, I would call, white paper that we would ultimately plan to do either with our internal groups or with a customer. What we do have is our internal test data and our top-level product claims at this point available.
spk13: Okay, great. And then last one for me, sticking on rapid sterility. On the dedicated rapid sterility Salesforce, is that Salesforce now fully staffed, ramped up, and ready for the launch? Yes.
spk05: Yeah. So we touched on this on the last call. Our core commercial approach is to leverage our existing Salesforce, who's been and continues to be increasingly trained on the platform. We will likely have a sterility specialist or specialist that can help with specific elements of the application discussion with customers. But we don't envision standing up a dedicated standalone sterility sales force per se.
spk02: Okay, great. Thanks for the clarification. Sure. Great.
spk05: Well, thanks to questions, Steve, and everyone. So thank you all for joining today. Have a great weekend.
spk03: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you. © transcript Emily Beynon Yeah. you Thank you. Thank you for standing by. My name is John and I will be your conference operator for today. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Mike Bollier, Head of Investor Relations. Please go ahead.
spk09: Good morning, and thank you for joining the Rapid Micro Biosystems first quarter 2024 earnings call. Joining me on the call are Rob Spignesi, President and Chief Executive Officer, and Sean Wurchis, Chief Financial Officer. Earlier today, we issued a press release announcing our first quarter 2024 financial results. A copy of the release is available on the company's website at rapidmicrobio.com under Investors in the News and Events section. Before we begin, I'd like to remind you that many statements made during this call may be considered forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events results, or performance are forward-looking statements, including but not limited to statements relating to Rapid Micro's financial condition, anticipated future cash usage and cash runway, guidance for 2024, including revenues, expenses, gross margins, system placements, and validation activities, expectations for and planned activities related to the company's business development and growth, customer interest and adoption of the growth direct system, statements regarding the planned launch and commercialization of rapid sterility, and the potential impact of macroeconomic uncertainty on Rapid Micro's business. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. For a list and description of these risks and uncertainties associated with Rapid Micro's business, please refer to the risk factors section of our most recent annual report on Form 10-K filed with the Securities and Exchange Commission as updated from time to time in our subsequent filings with the SEC. We urge you to consider these factors and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 3rd, 2024. Rapid Micro disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll now turn the call over to Rob.
spk05: Thank you, Mike. Good morning, everyone, and thank you for joining us. I will begin this morning's call with an overview of our first quarter performance and highlights, followed by a review of our priorities for 2024. I will then turn the call over to Sean for a more detailed review of our financial results and outlook. First quarter total revenue increased 11% to $5.6 million compared to the first quarter of 2023. This performance is ahead of the guidance we provided in March and represents the sixth quarter in a row that our revenue exceeded guidance. We placed three growth direct systems in the quarter, all to existing customers. First quarter recurring revenue increased 15% compared to Q1 2023 and has now grown by double digits in each of the 11 quarters since we became a public company. Consumable sales, which are part of recurring revenue, increased 22% year over year and achieved a new quarterly record, exceeding our prior record set in the second quarter of 2023. This strength in consumables demonstrates that customers are actively using their growth direct systems and are realizing value across their global manufacturing networks. In total, our first quarter results reflect a solid start to 2024, and we are reaffirming our full year 2024 revenue guidance of at least $27 million, representing at least 20% growth and at least 20 system placements. We continue to execute against our strategic priorities of accelerating system placements, improving gross margins, commercializing innovative new products, and prudently managing our cash. I'd like to provide a brief update and context for these priorities. Over the past few months, I visited with customers across North America and Europe. These meetings are always productive, and I would like to provide some recent customer feedback. The GrowthDirect value proposition is resonating, and customers are realizing meaningful benefits. They continue to plan further deployment of GrowthDirect systems across their global manufacturing networks. The many benefits of the Growth Direct's full automation include enhanced data integrity, improved accuracy, reduced human error, and lower hands-on labor costs. In addition, the Growth Direct offers operational efficiencies which can enable faster product release, less waste, and reduced inventories. Moreover, given the clear demand in the industry for increased manufacturing capacity, The growth direct speed and efficiency provide critical flexibility to manufacturing and quality control operations and can enable customers to unlock additional production capacity. Importantly, these operational efficiencies, which are ideally suited for the advanced modalities of biologics and cell and gene therapies, are also effective for other segments such as vaccines, sterile injectables, and small molecule manufacturing. The pace of growth in advanced modalities and the need for improved data integrity industry-wide is accelerating the adoption of automation. As customers implement automation across their manufacturing networks, we are confident that the growth direct is an important part of the solution. We continue to expect an acceleration in system placements in the second half of the year. Our confidence is underpinned by the size and quality of our sales funnel, a fully staffed global sales team, and visibility into growth direct purchases from our customers' senior level executives. Turning to our next priority, which is improving gross margins, we expect to continue to benefit from our initiatives focused on product cost reduction, manufacturing efficiency, and service productivity improvements. We remain on track for an inflection to positive gross margins in the second half of the year. Next, We look forward to the successful launch and commercialization of RapidSorility. Since our announcement earlier this year, customer interest for this breakthrough technology has been growing and has exceeded our expectations. Our commercial teams are trained and we are completing the technology transfer from R&D and into manufacturing with the associated scale-up activities. In June, we are hosting customers at our Lexington Innovation Center and demonstration lab for a live, hands-on experience with the GrowthDirect rapid sterility platform. We remain on schedule for a mid-2024 launch and look forward to providing an update on our second quarter earnings call in early August. Turning to cash management, we are focused on reducing our cash burn by tightly controlling operating expenses, capital expenditures, and working capital. So, to summarize our key messages from the first quarter, It was a solid start to 2024, including a record quarter in consumable revenue. The Growth Direct is providing a strong value proposition by delivering full automation, operational efficiencies, and improved data integrity. Customers continue to plan further deployment of Growth Direct systems across their global manufacturing networks. Early customer interest and rapid sterility is strong, and we are on schedule for a mid-year launch. Wrapping up my prepared remarks, I remain excited about our long-term outlook. We have a world-class customer base consisting of 70% of the top 20 global pharma companies, a proven technology with a strong value proposition that is embedded in customer workflows, an attractive high-growth business model with durable recurring revenue, and we are focused on our path to profitability and expect our cost, efficiency, and productivity initiatives to lead to positive gross margins in the second half of 2024 with continued improvement thereafter. And with that, I'll now turn the call over to Sean to discuss our first quarter performance and our outlook in more detail. Sean?
spk10: Thanks, Rob, and good morning, everyone. I'll start my comments today with a review of our first quarter results and then discuss our second quarter and full year 2024 outlook. Q1 revenue increased 11% to $5.6 million compared to $5 million in Q1 2023. During the first quarter, we placed three growth direct systems compared to three in the first quarter last year. We also completed three validations in the quarter compared to two in the first quarter last year. Product revenue, which is comprised of systems and consumables, increased 12% to $3.7 million in the quarter compared to $3.3 million in Q1 last year. The growth in product revenue was primarily driven by a record quarter on consumables as a result of continued growth in validated systems, as well as several shipments made during Q1 that were originally expected in Q2. Service revenue increased 11% to $1.9 million in the first quarter, compared to $1.7 million in Q1 last year. Service revenue growth was impacted in Q1 by some planned validation revenue that shifted into early Q2. The increase compared to the prior year quarter was primarily driven by a higher level of validation activity as well as higher revenue from service contracts due to the increase in the number of validated growth direct systems. First quarter recurring revenue, which consists of consumables and annual service contracts, increased 15% to $3.7 million compared to $3.3 million in Q1 last year. Non-recurring revenue, which is comprised mainly of systems and validation revenue, was $1.9 million in Q1 compared to $1.8 million in the prior year quarter. Turning to gross margins, product margins were negative $1.5 million in Q1, compared to negative $1.7 million in the first quarter last year. As we expected and as typical for our business, Q1 product margins stepped down from Q4 2023, mainly due to lower system placements and revenue. Compared to Q1 last year, the improvement was attributable to continued benefits from actions we've taken to lower product costs and increase manufacturing efficiency. These benefits were partially offset by some customer site readiness delays, which shifted $0.2 million in high-margin LIM software revenue from Q1 into Q2, an unfavorable product mix due to the higher proportion of consumable revenue in Q1 this year. Service margins were slightly negative in the first quarter, largely due to non-recurring expenses. This compares to negative $0.1 million in the first quarter last year. On a combined basis, our first quarter gross margin was negative $1.5 million, or negative 27%, compared to negative $1.8 million, or negative 36%, in Q1 last year. We continue to expect our Q1 gross margins to be the lowest of the year. We then expect meaningful improvement as we work our way through the remaining quarters as volumes and revenue increase, and we continue to make progress on our initiatives focused on product cost reduction and manufacturing efficiency as well as service productivity. Continuing down the P&L, total operating expenses were $12.8 million in the first quarter compared to $13.1 million in the prior year quarter, a reduction of approximately 3% versus the prior year period. R&D expenses were $3.8 million in Q1, an increase of 22% versus the prior year period, largely due to activities associated with the upcoming launch of Rapid Sterility. Sales and marketing expenses were $3.3 million, and G&A expenses were $5.6 million in the first quarter, representing a combined 10% reduction versus the prior year quarter as we tightly control spending in the business. Net loss was $13.3 million in Q1, This compares to a net loss of $13.9 million in Q1 last year. Net loss per share was 31 cents in Q1 compared to net loss per share of 32 cents in the prior year quarter. With respect to non-cash expenses and capital expenditures, depreciation and amortization expenses were $0.8 million, stock compensation expense was $1.1 million, and capital expenditures were $0.6 million in the first quarter. We ended the first quarter with approximately $80 million of cash and investments on our balance sheet. I'll now turn to our Q2 and full year 2024 outlook. We continue to expect total revenue of at least $27 million for the full year 2024, which assumes that we will place at least 20 systems. This implies year-over-year revenue growth of at least 20%. This guidance continues to reflect some uncertainty related to the timing and scale of customer purchase decisions. For the second quarter, we expect total revenue of at least $6 million, which assumes at least four system placements. We then expect revenue and placements to increase sequentially in Q3 and peak in Q4, consistent with our typical annual cadence and the guidance we provided in March. Looking at consumables, we expect revenue to decrease sequentially in Q2 compared to Q1, due primarily to the timing of customer orders and shipments. We then expect consumable revenue to increase sequentially in Q3 and then again in Q4 as mortgage systems complete validation and enter routine use. With respect to service, we expect revenues to be between $2 million and $2.5 million each quarter over the balance of the year, with variability within this range primarily driven by the timing of validation activities. We are reaffirming our guidance of at least 16 validations in 2024, including at least four in the second quarter. Turning to gross margins, we expect meaningful sequential improvement in the second quarter compared to the first quarter, but we still expect Q2 margins to be negative. Thereafter, we continue to expect positive gross margins in both Q3 and Q4, as well as for the full year. We expect product margins to improve each quarter based on ongoing cost reduction and manufacturing efficiency initiatives, as well as increasing volume, but remain negative. We expect double-digit positive service margins in each of the remaining three quarters of the year based on higher revenue and improved productivity. Looking forward, we remain confident in our ability to meaningfully improve our gross margins in 2024 and beyond as we continue to grow revenue, reduce product costs, drive higher manufacturing efficiency, control manufacturing overhead costs, and increase service productivity. We continue to expect operating expenses to be in a range of $48 million to $52 million in 2024, with depreciation and amortization expense of approximately $3 million, stock compensation expense of approximately $5 million, capex of approximately $3 million, and other income, which is comprised primarily of interest income, of approximately $4 million. Finally, we continue to expect cash burn of roughly $40 million for the full year 2024. Looking out further, our goal is to reduce cash burn meaningfully over each of the next several years as we drive towards profitability through a combination of revenue growth, margin improvement, and management of our OpEx, CapEx, and working capital. This supports our expectation that our existing cash and investments provide us with runway at least into the second half of 2026. That concludes my comments, so at this point, we'll open the call up for questions.
spk02: Operator?
spk03: At this time, if you would like to ask a question, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again. We'll pause for just a moment to compile the Q&A roster. The first question comes from the line of Tejas Savan from Morgan Stanley. Please go ahead.
spk06: Good morning. This is Yuko on the call for Tejas for taking a question. Some of your peers have been seeing worsening budget pressure leading to further elongation of sales cycles. Could you elaborate on whether you're seeing a similar dynamic? And what's your take on the customer sentiment with respect to large capex purchases?
spk05: Hey, Yuko, it's Rob. So our view and experience with customer budgets is similar to previous quarters. So what we're seeing is, I'd say, continued budget scrutiny with regard to CapEx purchases. And ours, at least for the quality control labs, is on the larger end. So it can pick up the second part of your question as well. So no meaningful changes. different changes over the past few quarters. But we have seen, I would say, more scrutiny. There's more cycles with regard to approval processes, a bit slower to get to an answer as well. That being said, we're executing through it. Moreover, another important dynamic to understand with rapid microbiome systems is the growth-directed in many cases, is considered a strategic project and program that impacts multiple sites around a customer's global manufacturing network. So, while that doesn't insulate us from these dynamics, we have seen notable cases where our projects for growth direct purchases have continued to be prioritized.
spk06: Got it. Thank you for that color. And then a separate follow-up question. With sterility launch expected in the mid-year time frame, could you elaborate on the remaining to-dos before commercial launch? And then also, is this something that you're actively communicating to your customer, or is it something you're holding until the customer event? If you are actively communicating the upcoming launch already, could you give us a sense for the customer interest you're seeing?
spk05: Yeah, so in reverse order, we have been We have been communicating to customers. We were communicating this at a recent trade show, the PDA annual show earlier this year, and the interest is, as we expected, quite strong. It reaffirms our belief and our voice of customer work that the market needs a rapid sterility automated system that has what I would call differentiated features from what's available in the market today. That's faster time to detection, much faster time to results, full automation, and the full complement of value proposition that the growth direct provides. Walk away, full automation, data integrity. Those, to our view, those features are not available in I'll call it other technology-enabled solutions in the market today, and certainly not in the legacy companion manual method, which is still the majority of the market. The first part of your question, the to-dos with regard to the serility launch, are the final elements of our development process to include the transfer to manufacturing. So think of this as the final stages of the R&D process, and then the the progressive handoff to the manufacturing organizations that will be charged with scaling up the product for commercial release and shipment to customers.
spk01: Great. Thank you very much.
spk02: Thank you.
spk03: The next question comes from the line of Dan Arias from Stifel. Please go ahead.
spk11: Good morning, guys. Thanks for the questions. Rob, can you maybe just talk a little bit about the confidence that you have and the acceleration of the instrument placement trajectory? I think by the end of the year, you're looking for something higher than where you are just based on that comment alone, but should we think one to two systems higher or by the time 4Q rolls around, can you be, you know, I actually have more than double what you did in 1Q, so... Just checking to make sure that you're on a path and that the sales funnel is suggestive of getting more than just a couple of boxes higher so that the full year kind of jives with where we are.
spk05: Yeah, so confidence standing behind our full year guide and at least 20 system placements and confidence is driven by a number of factors. Sales teams in the field executing globally a fully staffed team. The funnel in particular looks like we want it to look to backstop our guidance to size and composition, the geographic diversity of it, the customer diversity of it. And customers continue to spend a lot of time with customers, and this is where quite a bit of the confidence comes from as well, is customers are increasingly planning, continuing to plan deployments across their manufacturing networks. And increasingly, I'm seeing automation being viewed as a, as a critical strategic priority across customers' networks to include our automation. I mentioned as well, which is helpful for our guide, is we continue to get access to senior level executives at customers. We are becoming more of a strategic A, platform, and B, a larger spend from a practical standpoint in some of these large customers' quality manufacturing operations, and accordingly, we get better access to senior level decision makers. And that's where I spend quite a bit of my time as well. So that provides insight and confidence as well. And the last one would be sterility. I think we've mentioned we're not sort of expecting an enormous impact in the year, but we're serving the right for upside. So a number of these elements are colluding to give us confidence in our guide you know, notwithstanding the potential impact of Yuko's question of budget scrutiny.
spk11: Yep, okay. And then maybe on the consumable side, and it might be a question for Sean, but can you just talk a little bit about the consistency of where you are here going forward? Embedded with that or within that is a question about the customer that had sold the site, I believe, last quarter, which was impactful. Yep. Can you talk about that this quarter and then whether you're gaining some visibility on what that reacceleration at that one customer might look like?
spk10: Yep, sure. Yeah, so I think this quarter, as we mentioned in the prepared remarks, we did have some things that we expected in Q2 happen in Q1. So the growth that Rob mentioned, 22%, was the highest growth in the business kind of amongst the different product and service lines. And that does reflect a tough comp because of that customer site sale that you mentioned. So we did not have benefit from that in Q1. We clearly did have consumable sales into that site at kind of an ongoing high level in Q1 last year. So that, you know, that 22% would have been higher if it were not for that challenging comp as a result. So, you know, looking forward, you know, Guided down sequentially in Q2, largely based on the timing of the orders and the shipments of the consumables. So you've seen it the past couple of years. We do have a tendency to bounce around from quarter to quarter. I think more important to look at the annual trends and kind of where things are going in the pull-through. The pull-through was above 80% in the quarter. We talked last quarter about that pull-through for the year looking relatively flat this year, in part because of that site sale last year, part of the way through the year. Through the year, excuse me. So I think with them, we are in touch with them. I do expect we will see some contribution from them more in the second half of the year. I don't think it's going to be particularly close to the level that that site bought at in 2023 or the first half of 2023, but it is a positive sign for us that it feels like things are going in a direction where we'll be coming off the zero and moving up into some revenue contribution from that site in the second half.
spk11: Okay, and just to finish that thought, it feels like if, you know, I know we're still in the first half of 2024, but if I think about 2025, are you okay feeling like we're not going to have to sort of explain away that situation come the beginning of the year and that actually against the comps of this year it can be a tailwind?
spk10: Yeah, I don't see why that would, I mean, if anything, it should be a little bit of a tailwind next year on the comp. So, yeah, I don't think it'll be a negative discussion item in 2025.
spk02: Okay, super. Thank you.
spk03: Thanks, Dan. The next question comes from the line of Steven Ma from TD Collins. Please go ahead.
spk13: Great. Thanks for taking the questions. On rapid sterility on the June demo, can you give us a sense for the interest and types of organizations that are going to be attending?
spk05: Yeah, so we're still compiling all the customers, Steve, but we expect a representation from our current customer base, which leans towards biologics and selling gene therapies, but also customers from other segments such as sterile injectable manufacturing, where we're a bit less represented in our current placement. So the The approach and strategy around sterility is certainly penetration within our current customers, which is significant. As you know, we have the majority of the global top 20. I would say attracting new global top 20 companies that we don't have to include new segments as well. So we do expect a broad array and a diverse group of customers for those events.
spk13: Yeah. OK, great. Thanks. And then maybe speaking on rabbit sterility, I think you mentioned before in a prior call that there would be a technical presentation at a conference. Was that the trade show that you mentioned?
spk12: It was.
spk13: So, yeah.
spk12: OK. Yeah, we had it. We had it. We had a data published. I'm sorry. Was that data published somewhere or white paper or?
spk05: No, we have some internal documentation that was publicly furnished at the show, but we don't have a formalized, I would call, white paper that we would ultimately plan to do either with our internal groups or with a customer. What we do have is our internal test data and our top-level product claims at this point available.
spk13: Okay, great. And then last one for me, sticking on rapid sterility. On the dedicated rapid sterility Salesforce, is that Salesforce now fully staffed, ramped up, and ready for the launch?
spk05: Yes. Yeah. So we touched on this on the last call. Our core commercial approach is to leverage our existing Salesforce, who's been and continues to be increasingly trained on the platform. We will likely have a sterility specialist or specialist that can help with specific elements of the application discussion with customers. But we don't envision standing up a dedicated standalone sterility sales force per se.
spk02: Okay, great. Thanks for the clarification. Sure.
spk05: Great. Well, thanks to the question, Steve, and everyone. So thank you all for joining today. Have a great weekend.
spk03: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
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