Thank you for standing by. My name is Eloisa, and I will be your conference operator today. At this time I would like to welcome everyone to the Rapid Micro Biosystems’ Fourth Quarter and Full Year 2024 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. Thank you. I would now like to turn the call over to Mike Beaulieu. Please go ahead.

Good morning and thank you for joining the Rapid Micro Biosystems’ fourth quarter and full year 2024 earnings call. Joining me on the call are Rob Spignesi, President and Chief Executive Officer; and Sean Wirtjes, Chief Financial Officer. Earlier today, we issued a press release announcing our fourth quarter and full year 2024 financial results. Additionally, last night in a separate release, we announced a distribution and collaboration agreement with the Life Science business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. as MilliporeSigma. Copies of both releases are available on the company’s website at rapidmicrobio.com under Investors in the News & 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 including but not limited to, statements relating to Rapid Micro’s financial condition; assumptions regarding future financial performance; anticipated future cash usage; guidance for 2025 including revenue, expenses, gross margins, system placements and validation activities; expectations for and planned activities related to Rapid Micro’s business development and growth including our recently announced distribution and collaboration agreement; customer interest and adoption of the Growth Direct system; and statements regarding Rapid Sterility. 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 the risks and uncertainties associated with Rapid Micro’s business, please refer to the risk factors section of our most recent quarterly report on Form 10-Q 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. The conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 28, 2025. 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 turn the call over to Rob.

Thank you, Mike. Good morning everyone and thank you for joining us. I will begin my prepared remarks with a brief overview of our fourth quarter 2024 performance and highlights as announced in our press release this morning. I will then discuss the global distribution and collaboration agreement we announced last night before turning the call over to Sean, who will provide a more detailed review of our financial results and our 2025 outlook. Total revenue was $8.2 million in the fourth quarter representing 30% year-over-year growth and a quarterly record. Recurring revenue was $4.2 million, representing growth of 27% compared to the prior year quarter. We placed six Growth Direct systems in Q4, bringing our total of 21 system placements for the full year. On an accumulative basis through the end of 2024 we have now placed 162 Growth Direct systems globally, including 137 fully validated systems. Fourth quarter gross margins improved to 12%, up sequentially from 8% in the third quarter and a 15 percentage point improvement compared to the prior year quarter. This reflects continued progress in improving our cost structure and enhanced operating leverage in the business. This strong fourth quarter performance marks our ninth consecutive quarter of meeting or exceeding our revenue guidance and positions us well for 2025. Now I’ll turn to last night’s press release announcing our global distribution and collaboration agreement with the Life Science business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. as MilliporeSigma. To begin, I will provide some context around our decision to enter into this agreement and why we believe MilliporeSigma is an excellent strategic partner for Rapid Micro Biosystems. As a longstanding global leader in life sciences, MilliporeSigma shares a common customer base in the pharmaceutical segment with Rapid Micro Bio offering a comprehensive and complementary product portfolio supported by an extensive commercial organization with deep relationships and experience selling into pharmaceutical quality control and manufacturing. Moreover, MilliporeSigma also serves adjacent segments such as personal care and medical devices, among others. This aligns strongly with our top priority of accelerating Growth Direct system placements. Additionally, as a global supplier to the life sciences industry, this partnership with MilliporeSigma presents opportunities to bring efficiencies to our supply chain to reduce product costs and accelerate our goal of improving gross margins. Finally, this partnership creates opportunities to drive innovation and develop new technologies and products. So with that as context for this partnership, let me now provide more details of the agreement. MilliporeSigma has global co-exclusive rights to sell the Growth Direct system and related consumables. Their extensive global commercial network, which reaches beyond traditional pharma and biologics manufacturing into key adjacent markets such as personal care, medical devices, cosmetics, and food and beverage, aligns well with Rapid Micro’s long-term growth objectives. By leveraging MilliporeSigma’s scale and expertise, we expect they will significantly expand Growth Direct’s reach, enhance accessibility with existing customers, and attract new customers. Additionally, access to these adjacent markets will substantially increase Growth Direct’s total addressable market. For the first two years of this five-year agreement, MilliporeSigma has committed to purchase a minimum number of Growth Direct systems in a way that is heavily weighted towards the second year, and we expect it to have a meaningful impact in 2026. At the same time, and throughout the full term of the agreement, Rapid Micro will continue to utilize its existing global direct sales team and distribution channels to sell and place Growth Direct systems. Importantly, we will also continue to validate and service all Growth Direct systems to include the systems MilliporeSigma sells. A key component of this agreement is a joint commitment between Rapid Micro and MilliporeSigma to identify opportunities to bring efficiencies to our supply chain to accelerate our goal of gross margin improvement. Initial focus areas for this collaboration may include culture media, plastic consumables, sterilization, logistics and warehousing, as well as packaging. We are confident that this collaborative approach will build upon our recent progress, and deliver incremental and sustainable improvements in gross margin. And lastly, the agreement enables opportunities for collaboration on joint development of new products, enhancement of existing products and expansion of service offerings to benefit customer workflows and create additional revenue and margin opportunities. We held a multi-day planning and kickoff meeting with our MilliporeSigma colleagues this week and we could not be more excited to partner, in fact we are a recognized and highly respected leader in the life sciences industry. This agreement combines Rapid Micro’s market-leading Growth Direct technology platform with MilliporeSigma’s global scale, brand strength, and industry leadership. We are confident this collaboration will enhance value to customers worldwide, while meaningfully advancing our priorities of accelerating Growth Direct system placements, improving gross margins, and driving innovation. Before turning the call over to Sean, I’d like to share my perspective on our outlook for 2025. Our priorities this year remain consistent with 2024. Our top priority remains accelerating Growth Direct system placements. Second, we remain focused on improving gross margins. Third, we are committed to developing and commercializing innovative new products. Lastly, we will continue to prudently manage our cash and maintain a strong balance sheet. Our successful collaboration with Lonza, which resulted in end-to-end automation of the environmental monitoring QC process using the Growth Direct platform across our global cell and gene manufacturing network, reinforces our confidence that we are the industry standard and provides a clear blueprint for the industry to emulate. We have multiple customers in our sales funnel that plan similar global, multisystem rollouts. This also includes a growing sales funnel for Rapid Sterility, which is being driven by its value proposition for full automation and faster time to results for this critical end-of-line test. In 2025, we expect to improve gross margins by building upon our second half 2024 inflection and continuing our programs to reduce product costs, enhance manufacturing efficiencies, and improve service productivity. We expect further gains in operating leverage as we move forward and will remain disciplined with cash management. While we believe there is potential for MilliporeSigma to contribute to revenue in 2025, we are not assuming any contribution in our outlook. However, we expect this partnership to have a transformative impact on the business to include our system placement and margin improvement priorities, driving meaningful benefits in 2026 and beyond. With this in mind, we believe our outlook is both prudent and achievable and look forward to updating you as the year progresses. In closing, we believe the strength of our underlying business, the significant advantages of our partnership with MilliporeSigma, and our continued focus on delivering value to customers position us to drive sustained shareholder value creation in 2025 and beyond.

Thanks, Rob. And good morning, everyone. I’ll begin my comments this morning with a review of our fourth quarter 2024 results and then discuss our first quarter and full year outlook for 2025. We will then open the call up for questions. Fourth quarter revenue increased 30% to a record $8.2 million compared to $6.3 million in Q4 2023. During the fourth quarter, we placed six Growth Direct systems, which was consistent with the fourth quarter last year. We also completed four validations in the quarter compared to nine in Q4 last year. Product revenue, which is comprised of systems and consumables, increased 27% to $5.2 million in the fourth quarter compared to $4.1 million in Q4 2023. Consumable revenue grew by over 30% in the fourth quarter compared to Q4 last year. Service revenue increased 35% and to $3 million in the fourth quarter compared to $2.2 million in Q4 2023. This was driven by double-digit revenue growth across validation services, field service, and service contracts. Fourth quarter recurring revenue, which consists of consumables and service contracts, increased 27% to $4.2 million. Nonrecurring revenue, which is comprised mainly of systems and validation revenue, increased 32% to $4 million. Turning to gross margins. Product margins were negative 8% in the fourth quarter, compared to negative 14% in Q4 2023. The improvement was largely due to continued progress on product cost reduction initiatives and increased manufacturing efficiencies in our consumables business. Service margins were a record $1.4 million or 47% in the fourth quarter compared to $0.4 million or 19% in Q4 last year. The 28 percentage point improvement was driven by higher revenue and productivity as well as lower headcount and other service-related costs. On a combined basis, fourth quarter gross margins were a record $1 million or 12% compared to negative $0.2 million or negative 3% in Q4 last year. Of note, full year 2024 gross margins were effectively breakeven compared to negative 24% for the full year 2023. We are pleased with the significant progress we’ve made in margins over the course of the past two years and remain laser-focused on driving substantial incremental improvement moving forward. Moving down the P&L. Total operating expenses were $11.2 million in the fourth quarter, representing a decrease of 7% from $12 million in Q4 2023, largely due to benefits from the operational efficiency program we announced in August 2024. Within OpEx, R&D expenses were $3.4 million, representing an increase of 3%, which was mainly associated with new product development activities. Sales and marketing expenses were $3 million, representing a decrease of 6%, and G&A expenses were $4.8 million, representing a decrease of 13% due mainly to lower headcount-related costs. Net loss was $9.7 million in Q4. This compares to a net loss of $11.2 million in Q4 last year. Net loss per share was $0.22 in Q4 compared to a net loss per share of $0.26 in the prior year quarter. With respect to non-cash expenses and capital expenditures, depreciation and amortization expenses were $0.9 million, stock compensation expense was $0.7 million and capital expenditures were $0.1 million in the fourth quarter. We ended the year with approximately $51 million in cash and investments. Now I’ll turn to our 2025 outlook. While we believe there is potential for MilliporeSigma to contribute to system placements in revenue in 2025, our initial guidance does not assume any such contribution. We believe this is prudent given our typical sales cycle. Conversely, our guidance does account for some ongoing uncertainty around the timing and scale of customer purchase decisions particularly with respect to larger multisystem opportunities, which often involve more complex purchasing considerations and processes. With that as context, we expect full year 2025 total revenue of at least $32 million with between 21 and 25 system placements. We expect Q1 revenue of at least $6.5 million, including at least three system placements with the sequential decline from Q4 consistent with typical seasonality. We then expect revenue and placements in Q2 and Q3 to be higher than Q1 and then peak in Q4. Looking at consumables, we expect Q1 revenue to step down slightly from Q4. We then expect consumables revenue to be higher than Q1 in the remaining quarters with variability driven by the timing of customer orders and shipments. With respect to service, we expect revenue to be between $2.6 million and $3 million in Q1, which is likely to be our highest service revenue quarter in the year, primarily due to the timing of validation activities. We expect to complete at least 18 validations in 2025 with at least five in the first quarter. Turning to margins. We expect Q1 gross margins to be slightly positive but lower than Q4 due to the revenue seasonality impact I mentioned earlier. Thereafter, based on our revenue outlook, we expect to maintain positive gross margin in each succeeding quarter of 2025 with variability driven by progress on our product cost reduction and service productivity initiatives. Overall revenue volumes and the revenue mix between systems, consumables, and service in each period. For the full year 2025, we expect gross margin as a percentage of revenue to be in the range of high-single digits to low-teens. We expect operating expenses to be between $44 million and $48 million for the full year, which reflects the full effect of savings from the operational efficiency program we announced in August 2024. We expect depreciation and amortization expense of $3 million, stock compensation expense of $4 million, CapEx of $2 million and other income, which is comprised primarily of interest income of $2 million. Finally, we expect to burn roughly $30 million in cash for the full year 2025, which would be a roughly $14 million reduction compared to our cash burn in 2024. Looking further ahead, our strategic priorities of accelerating system placements, improving gross margins, innovating new products, and prudently managing our cash remain unchanged. Building on our momentum, we believe that our distribution and collaboration agreement with MilliporeSigma has the potential to further accelerate progress on these strategic priorities over the coming years, including a meaningful contribution to system placements beginning in 2026. That concludes my comments. So at this point, we’ll open the call up for questions.

Your first question comes from the line of Dan Arias of Stifel. Please go ahead.

Good morning guys. Thanks for the questions. Rob, do you think that the Millipore relationship accelerates your entry into new areas that maybe you’re not focused on now? I mean, it seems like some of these non-traditional corners of the opportunities that could be open to you sooner if you have those guys helping you out, but I’m not sure whether you see that as the right move strategically when you just think about resources and focus and hitting the ground running on some of the things that you’re currently doing?

Hey, Dan. I appreciate the question. And the quick answer is yes, I do. So as we’ve discussed in previous calls, there are adjacent markets such as personal care and cosmetics and medical devices that are meaningful in size. But given our focus in pharmaceutical manufacturing, we’ve been focused on pharma and biologics and cell and gene, etc. So the MilliporeSigma team is well positioned in those adjacent markets. And that is a fundamental plank in the strategy behind the relationship.

Okay. And then Sean, on the instrument placement outlook for the year, the low end of the guide is actually no better than what you did in 2024. And even the midpoint is only two systems higher. Most people think the spending situation in pharma is better than it was last year. It looks like you have a nice win here with Lonza. You’ve got Millipore in the picture, at least in the picture if they’re not helping in 2025, they are at least there. So help me with the 2021 to 2025. I mean obviously, prudence is a good idea here, but it seems like they’ve certainly got the components of something – for something more. I just want to make sure I’m not missing an element here that would be material to the outlook.

Yes. Sure, Dan. Yes. So you said one of the key words there, I think, prudent and achievable. That’s our goal, our philosophy as we kind of come into the new year and set our guidance. I think in the broader environment, I don’t think we are seeing meaningful changes from what we’ve seen in 2024 in terms of how customers are operating around the purchasing process, the bar still tends to be a little higher than it was at certain times in the past. So we’re continuing to monitor that, but I don’t think we’ve seen any meaningful improvement in that at this point. And that assumption is baked into this guidance. I think we touched on it in the script, I think, very importantly, we are not including anything for MilliporeSigma. We do think there’s an opportunity there. But it’s going to take some time to get them up to speed. Obviously, our sales cycle can be 12 months plus. So factoring that in kind of the rationale for the approach that we took there. And then I think, given the environment and what we’re seeing and not seeing there, we have a number of large multisystem orders in the funnel and we’re not baking those into the guide right now just given the environment and the time that we expect it will take to bring those resolutions. So to the extent we’re able to convert those during the year, that will be upside as well. So that’s kind of how we approached it coming into the new year in 2025.

Is there something…

Dan, I can just add on.

Sorry.

You go, Dan, I go then.

Okay, here I go. Are there some number of systems that you expect to go to Lonza through this collaboration this year?

So I’ll speak more broadly. This is the point I was going to make, Dan. So it’s an important note or feature that it bears repeating. So our guide for 2025, as Sean mentioned, does not include any contribution from our new collaboration with MilliporeSigma nor does it include the more meaningful multisystem orders that we have in our funnel that we are quite excited about. And there are multiple. And the reason why we have not included those again, consistent with our prudent approaches, while exciting, they can – and they’re moving, they can also be tough to put a pin in with regard to timing. These are typically global in nature, multisite, multi-region, multi-stakeholder. And as you may imagine, they can be a little more complex and a bit more time-consuming to close and ship. That’s why we haven’t concluded those. That all being said, we reserve the right for upside here on both the MilliporeSigma relationship in 2025 as well as our direct selling against some of these large multisystem orders. And as I mentioned in the remarks, we’ll keep everyone updated as the year unfolds.

Okay. Appreciate it. Thank you.

Your next question comes from the line of Paul Knight with KeyBanc. Please go ahead.

Hey, Rob. On the Merck and Millipore collaboration, are they going to sell into biopharma? Or is it biopharma in a particular region? How do you prevent same people in the same building? And then the other is, what do you think that does for gross margin with Merck KGaA involved? Do you have a margin pickup goal maybe in even 2026 from them getting involved maybe in supply?

Hey Paul, thanks for the question. So the first one, basically goes to channel compatibility effectively. Yes, they will be selling into not only pharmaceutical and biologics, but more broadly on segment, personal care, cosmetics, et cetera, which we consider a growth adjacency that we’re not currently in. With respect to our core market of pharmaceutical manufacturing, we have been diligently working with the team and are comfortable with our go-to-market approach and how we’re going to manage our respective sales funnels. With regard to margin, yes, the goal here, again, the strategy, as I touched on behind the MilliporeSigma relationship is to catalyze and accelerate our core priorities of accelerating system sales, which we touched on. Gross margin improvement, which will come through not only volume, we anticipate, but also, as I mentioned, a lot of the components, especially our consumables, notably, from a cost of material standpoint, MilliporeSigma has in their portfolio. So there are definitely opportunities there to improve supply chain efficiencies with regard to our factors of input. And then, of course, downstream through logistics and shipping also, there are meaningful opportunities. So we would anticipate and it is part of the core strategy here that margin improvement would feature prominently in our relationship.

Yes. And Paul, we actually don’t procure anything of substance from them today. So we have a relatively clean slate to go after. And as Rob mentioned, particularly with our consumables, you kind of look at the major materials that go into those, it’s a pretty good match up in terms of what we use and what they can provide.

Right. Okay. And then regarding the Lonza relationship, obviously they’ve been pretty vocal recently on your system. Are you seeing, a), pickup from Lonza kind of encouraging the industry to adopt? And, b), it seems like you’re essential at Lonza. Is that fair to say?

Yes. So in reverse order, I’ll let Lonza to opine on how essential we are. Our opinion is we are clearly, as we – as our goal, as you know, is to build a new quality control infrastructure for pharmaceutical manufacturing globally. And the Lonza example is a very, very, very good example of it. But frankly, it’s how a lot of our customers are seeking to deploy, not every customer does a great job like Lonza in a white paper like this. But this is really the – it’s playing to our forehand, if you will, as far as how customers when you hear us these global deployments. This is how it looks to include the data benefits and interconnectivity with the fundamental technology systems. And we do anticipate that we will continue to grow with Lonza and future deployments, and future sites through the coming quarters and years.

Okay. Thanks.

Your final question comes from the line of Brendan Smith with TD Cowen. Please go ahead.

Great progress in the quarter and on the great deal, good to see. Thanks for taking the questions. I wanted to actually first ask if you’re able to tell us how many systems Millipore actually committed to purchase over these first two years? And then actually, just kind of given all the automation work with Lonza, I’m just wondering if you have any updated thoughts on potential AI integration or any evolving strategy on that front, again, just kind of given all the possibilities with the automation QC work?

Thanks Brendan. It’s Rob. So we can’t comment on the actual commitment for the commercial agreement. We can’t quantify it. But as I mentioned in the remarks, and I think Sean followed it up as well, it will be significant beginning in 2026. With regard to Lonza and more broadly, our approach to data, yes, for the – for we view, at least with regard to where we operate inside these large companies, we’re creating a large amount of digital data that didn’t exist before. So the opportunity is part of our innovation strategy. And this could intersect now in a collaborative way with MilliporeSigma, how we manage that data, how we can potentially pull it into an AI or cloud environment to provide enhanced insights and services for our global customers. Let’s just say, it’s something on our radar and would be very exciting for not only us but the industry more broadly.

Great. Thanks guys.

Well thanks Brendan. Okay all. We’re going to wrap up our call this morning. Thank you for joining us today, and we look forward to speaking with many of you soon. Have a great weekend.

Ladies and gentlemen, that concludes today’s call. Thank you for joining. You may now disconnect.