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spk07: Thank you for holding, and welcome everyone to the Rapid Micro Biosystems 3rd Quarter 2023 Earnings Call. 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'd like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you'd like to withdraw your question, again press the star 1. Thank you. I'll now turn the call over to Mike Bollier, Investor Relations. Mr. Borley, go ahead.
spk00: Good morning, and thank you for joining the Rapid Microbio Systems third quarter 2023 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 third quarter 2023 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 year-end cash balance, cash runway, future revenue, and system placements, expectations for and planned activities related to the company's business development and growth, customer interest and adoption of the growth direct system, expectations for RMB nucleus mold alarm and 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 the risks and uncertainties associated with Rapid Micro's business, please refer to the risk factors section of our annual report on Form 10-K filed with the Securities Exchange Commission on March 10th, 2023 as amended as such risk factors are updated 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, November 3rd, 2023. 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.
spk05: Thank you, Mike. Good morning, everyone, and thank you for joining us to review our third quarter 2023 results. I will begin this morning's call with an overview of our third quarter performance, followed by a review of the progress we have made in advancing our growth strategy. I will then turn the call over to Sean for a more detailed review of our financial results and outlook. Total revenue was $6.1 million, representing a 30% increase compared to Q3 last year and above our guidance for the third consecutive quarter. The strength was broad-based. with growth of approximately 30 percent in both product and service revenue for the second consecutive quarter. Based on our solid year-to-date results and supported by a strong balance sheet, we are reaffirming our guidance of at least $22 million in revenue, representing approximately 30 percent growth for the full year. During the third quarter, we placed five growth direct systems, including at least one in each of North America, Europe, and Asia. This included the placement of a system with a new top five global pharma customer. As a result, our customer base now includes two-thirds of the global top 20 pharmaceutical manufacturers. We also completed four validations in the quarter. With all three sales regions staffed, our funnel has expanded meaningfully since the start of the year and is well-balanced geographically. Biologics and cell and gene therapy customers remain our largest opportunities. as a growth direct is ideally suited for the high volume testing, full automation, robust data integrity, and fast turnaround time required in these segments. That being said, we also have meaningful opportunities in segments such as small molecule and sterile injectable manufacturing, where our global commercial presence is providing insight and access to new opportunities. As many of you are aware, there are several thousand clinical trials for biologics in approximately 1,000 clinical trials for cell and gene therapies ongoing today. With the Growth Direct, customers can achieve faster time to results, improve data integrity, enhance accuracy, and greater sample capacity than current methods. In these high-value segments, the value proposition of using the only fully automated rapid detection platform for microbial quality control clearly resonates with this customer base. In fact, the Growth Direct is currently being used in the manufacture of five of the six commercially approved CAR T therapies and expected to place a system with the one remaining therapy later this quarter. We also have a significant footprint within biologics manufacturing, which remains our largest segment for system placements. Notably, according to the FDA, there are close to 700 licensed biologic therapies currently on the market, which creates a large growth opportunity. Our significant progress and penetration into the commercial cell and gene and biologics market, combined with our presence within the majority of the global top 20 pharma companies, speaks to the value proposition of the Growth Direct. We are proud to be trusted partners on these critical, lifesaving therapies and believe that this level of success keeps us on a path to establishing the Growth Direct as the industry standard for pharma microbial QC testing globally. As we continue to focus on our commercial execution and specifically on accelerating system placements, one of our objectives is to increase opportunity generation and the velocity of our funnel through direct customer engagement. We recently opened a growth direct demonstration lab in our Lexington, Massachusetts facility and have already hosted several prospective customers. This new lab complements our state-of-the-art automated consumable manufacturing line and provides a platform to showcase our comprehensive set of manufacturing and operations capabilities to customers. During these tailored customer interactions, we include detailed discussions about professional services, which include validation and system integration support. This high-touch approach to selling instills confidence in our customers and reinforces our position as a trusted, long-term strategic partner of choice. Additionally, we continue to use our customer demonstration lab near Munich, Germany, to host high-value events for our European customers. In early October, we again participated as a platinum sponsor at the annual PDA Pharmaceutical Microbiology Conference. In addition to the conference, we hosted an invite-only event where prospective and existing customers are paired with members of our commercial and executive leadership team to enable deeper engagement with key users and decision-makers. Over the three-day conference and including our customer event, we generated numerous high-quality leads. And finally, in late November, Johnson & Johnson will host a multi-day Growth Direct event at their site in Scheffhausen, Switzerland. The purpose of this event is to facilitate collaboration and education by bringing together industry thought leaders, customers, and prospective customers to discuss current business goals and to share best practices. We anticipate that over 60 customer participants will attend, and the event will feature expert panel discussions on topics such as automation and regulatory approaches using the Growth Direct. In addition, participants will tour a local customer site that includes a fully validated Growth Direct system in a GMP environment. New product development is another important component of our growth strategy. Our goal is to innovate new products that solve customer challenges and create meaningful differentiation and competitive advantage, strengthen partnerships, and enhance the growth of REX value proposition. Additionally, we expect innovative products such as Mold Alarm and Rapid Sterility to become new sources of revenue growth and drive margin expansion. With respect to Rapid Sterility, we continue to increase focus on commercialization and expect to be able to provide a more significant update next quarter. In summary, We continue to make good progress against our growth strategy. Accelerating system placement remains our highest priority. Despite the ongoing challenges posed by the macroeconomic environment, we have achieved nearly 30% growth year-to-date through Q3, which demonstrates that the actions we have been taking to improve our commercial execution and enhance customer experience are gaining traction. Additionally, we are focused on leveraging internal cost initiatives, which combined with the scale we are beginning to achieve, will continue to drive gross margin improvement. And with that, I'll now turn the call over to Sean to discuss our third quarter performance. Sean?
spk01: Thanks, Rob, and good morning, everyone. I'll start with a recap of our third quarter 2023 results, followed by our updated outlook. Q3 revenue increased 30% to $6.1 million, compared to $4.7 million in Q3 2022. We placed five growth direct systems in the third quarter this year compared to three in Q3 last year. Product revenue, which is comprised of systems and consumables, increased 31% to $4.2 million in Q3 compared to $3.2 million last year. The growth in revenue was primarily driven by the two additional system placements in the quarter. Consumable revenue increased on a year-over-year basis but was down slightly on a sequential basis following a record second quarter due mainly to the timing of customer shipments between Q2 and Q3 both this year and last year. Service revenue increased 27% to $1.9 million in the third quarter compared to $1.5 million last year. The increase was largely driven by higher recurring service contract revenue, which grew almost 40% in the quarter. Third quarter recurring revenue increased 17% to $3.4 million compared to $2.9 million last year, driven by the growth in both consumables and service contract revenue. Non-recurring revenue was $2.7 million in Q3 compared to $1.8 million in the prior year quarter. Turning to gross margins, product margins were negative $1.5 million in Q3 compared to negative $2.4 million in the third quarter last year, The improvement was mainly due to higher placements in production volumes and systems and favorable consumables product mix in Q3 this year, as well as the one-time write-off of expired materials and consumables in Q3 last year. This improvement was partially offset by the impact of planned downtime on our automated consumables manufacturing line to implement enhancements that will benefit future margins, as we discussed on our last earnings call. These enhancements are now substantially complete, and we expect them to start making a meaningful contribution to improved consumables margins beginning in the fourth quarter of this year. Service margins were negative $0.1 million in Q3 compared to negative $0.4 million last year. Leverage from higher revenues and better productivity drove the improvement in service margins in the quarter. On a combined basis, our third quarter gross margin percentage was negative 27%. representing an 11 percentage point improvement on a sequential basis and a 32 percentage point improvement compared to the third quarter last year. Looking at margin improvement another way, our total cost of revenue only increased 3% year over year compared to the 30% increase in total revenue we realized in the same period. This illustrates the progress we are making in implementing manufacturing efficiencies and cost reductions across both products and services, as well as the benefits of higher revenue increasing production volumes, and tight control of overhead costs. We are laser focused on the activities we believe will drive significant long-term and sustainable improvement in our gross margins. Continuing down the P&L, total operating expenses were $12.8 million in the third quarter, consisting of $3.5 million in sales and marketing, $3.1 million in R&D, and $6.2 million in G&A. This compares to total operating expenses of $14.1 million in the third quarter of 2022. The decrease was largely due to non-recurring costs incurred in the third quarter of last year associated with the strategic review process initiated by our board of directors in that period. Net loss was $13.4 million in Q3. This compares to a net loss of $16.3 million in Q3 last year. This improvement was largely due to higher revenue, better gross margins, and lower operating expenses in Q3 this year. Net loss per share was $0.31 in Q3 compared to net loss per share of $0.38 in the prior year quarter. With respect to non-cash expenses and capital expenditures, depreciation and amortization was $0.8 million, stock compensation expense was $1.3 million, and capital expenditures were $0.5 million in the third quarter. I'll now turn to our outlook. We are once again reaffirming our previous full-year 2023 revenue guidance of at least $22 million, which represents growth of at least 30% and assumes we will place at least 15 systems. Compared to Q3, we expect Q4 system revenue to be relatively consistent, consumable revenue to be slightly lower due mainly to shipment timing, and service revenue to be higher due to increased validation activity. We expect to complete at least five validations in the fourth quarter, which is consistent with our prior guidance. In light of the current macroeconomic environment, our customers continue to scrutinize the timing and scale of purchase decisions. And while our guidance continues to reflect this uncertainty and our teams continue to effectively navigate this environment, we expect these headwinds to persist through the end of the year. Shifting the gross margins, we expect sequential improvement in Q4 as we benefit from higher production volumes and cost reduction activities and consumables, as well as the benefit of higher revenue and increased productivity and service. Gross margin improvement continues to be a top strategic objective for us. We are focused on driving cost reduction and increasing manufacturing efficiency in products and increasing productivity in services. We continue to expect these actions, as well as the benefit of higher sales volumes, to lead us to positive gross margins in 2024, with expansion to 50% to 60% as the business continues to scale over time. We expect Q4 operating expenses to be between $12 million and $13 million. Finally, we finished the third quarter with approximately $104 million in cash, cash equivalents, and investments. Cash burn was approximately $9 million in the period. In the fourth quarter, we expect cash burn to be slightly less than Q3 as we realize cash benefits from working capital management. As a result, we expect to end 2023 with cash and investments slightly below $100 million and remain confident that this will provide us with cash runway at least into 2026. That concludes my comments, so at this point, we'll open the call up for questions. Operator?
spk07: Certainly. At this time, if you'd like to ask a question, please press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. with Morgan Stanley, your line is open.
spk04: Good morning, guys. This is Edmond . Thank you for taking my questions. Just to start, with five systems placed in the quarter, your guidance implies more for the remainder in 4Q. Just wondering what underlies your confidence in being able to deliver that in 4Q, and what do you currently have baked into your guidance in terms of a year-end budget flush?
spk05: Yeah, so this is Rob Spignassi. Thanks for the question, Edmund. Really, our confidence in delivering the full Deliving our guidance comes from a couple different areas. First of which, we've got a full team staffed, as I discussed in the remarks. Globally, we've got good penetration into the top customers, global top 20. We've got increasing senior access into the senior leadership of the top 20. And notably, the conversations that we're having give us confidence and insight into the purchasing approaches and timing within these large customers. The funnel, notably and importantly, looks the way we want it to look to give us confidence in our outlook. And another strong leading indicator we look at is customer experience, which we measure closely and is quite high. So the combination of these elements is what gives us confidence in our outlook. Now, with regard to Q4 budget flush, A, we're not seeing it, and B, we don't expect a traditional, if you will, budget flush, nor are we seeing what I would call a budget freeze. So it's been fairly consistent with what we've seen in previous quarters that we've mentioned. So it really is a customer-by-customer situation. And in some cases, not all, in some cases, the growth direct has been prioritized as a corporate level initiative. So it's a bit more resilient to the current budget environment. Although in some cases, we've seen customers push projects to the right into 2024. So the combined elements of all the above is what gives us confidence in our outlook for Q4.
spk04: Great, Rob. Thank you for the detail. That's super helpful. And then in terms of Project Rapid for short invalidation time, platform. I was wondering if you could help us benchmark how the project is performing. And are you seeing the same magnitude of impact between both existing customers and new customers? And finally, if you could remind us, aside from dedicated project managers, what are some of the other areas of opportunity that you guys are leveraging to shorten the wrap time?
spk05: So we are seeing broad-based performance with new and existing. And for those that are listening that aren't aware of it, I'll just back up. Project Rapid is a project that designation for an umbrella set of activities that we have to accelerate our validation processes. There's multiple elements that we need to work through with our customers under good manufacturing principles to go from an installation to the system of record through various validation processes to ensure the system is validated for use in a manufacturing environment. So over time, we've improved our capability in this regard. We have over 100 systems validated globally in GMP environments, and we've learned with our customers not only to accelerate the process, but also to harmonize the process. And we've worked hand in glove. One of the most exciting things we've done as a company is harmonized our global validation processes with with our large customers. And both our existing customers, as I touched on, and our new customers benefit from that. So some of the activities that help to accelerate our validation on our Project Rapid, as I've been touched on, we've got project management in place. So this is dedicated global product management. This is effectively a project management management process to get from an installation to validation. So we've got dedicated product managers. We have very experienced validation personnel who go in on-site with customers. We've improved our documentation and our data, so we're able to bring data to bear to accelerate the process versus generating data on-site. And we're down the learning curve. We understand where validation processes can be accelerated, where they typically slow down, where customer challenges are. So we're able to come in with a deep experience base in order to accelerate the process. And we do this globally across all the sites that we interact with. I view it as one of our fulcrum capabilities, and it's one of the areas that customers strongly appreciate our capabilities in.
spk04: Great, Rob. Thank you for the answers and the time today.
spk07: Dan Arias with Stifel. Your line is open.
spk03: Hey, good morning, guys. Thanks for the questions. Rob, maybe just to follow up on your new versus existing customer comment there. When you think about the sales funnel that will translate to orders and revenue next year, how does the mix look when it comes to placement at those new accounts versus repeat purchases? And then as a follow-up to that, on the selling gene therapy side, you sound kind of positive there. Can you just talk about how those conversations are going? Obviously, there are some ups and downs with some of those companies and the things that they're experiencing these days and just the spending level that you might expect there. So how does visibility compare there to the other parts of the market?
spk05: Yeah, Dan, thanks for the question. So with regard to new versus existing, it's It's balanced. It's weighted towards existing customers, as you may imagine. And you heard, we brought a new one on. So as we continue to chip away at some of the larger customers out there, our funnel, our outlook on our funnel is weighted in that direction, given our land and expand strategy. That being said, again, with the full team out there across North America, Europe, and Asia, we are generating new opportunities kind of across our segments that include both new and existing. So we like the way our funnel looks with regard to both new and existing. And as I mentioned, we're excited about what we're hearing and seeing with some of our larger customers and getting better insight into their rollout plans and budgets against those. Now, on the cell therapy front, I think you heard with regard to CAR-T in particular or cell and gene generally and CAR-T in particular, we've done well there. our value proposition resonates quite well. So I think it's a situation where our particular technology fits their manufacturing needs quite well, and it's really, in our view, the only real fully automated system that can serve their needs. More broadly in cell and gene therapy, So we are active with CDMOs who operate in that space that the CDMO business is healthy, as well as, obviously, the broader ecosystem with plasma manufacturers and other who continue to be healthy as well. So we're obviously watching it. We're strong in the space broadly. But as I mentioned on the call as well, we've got a good footprint in biologics manufacturing, which is our largest segment, and small molecule as well. So We watch our segment mix carefully, and while we're strong in cell and gene therapy, it certainly isn't the only segment that we're focused on. And again, it's important to note that biologics is our largest segment.
spk03: Yeah, gotcha. Okay. And then, Sean, on consumables, how do you think pull-through tracks on an annualized per-system basement into year-end And then can you just touch on why consumables will be down next quarter? I think that's actually two sequential down quarters. Yeah. It seems like you feel pretty good about momentum. So maybe just touch on how consumables faces over the next one to two quarters. Sure.
spk01: Yeah. So to break it down, we still expect to grow single digits in – In year-over-year pull-through, effectively, when we look at the full year, I think, do we get the high single digits? We have a few headwinds that may keep us from getting quite to where we thought we'd get to a couple quarters ago, but it's mainly due to timing. So if you kind of break down Q3 and Q4, Q3, a couple things working against us in terms of year-over-year growth. One is that we had a couple hundred thousand dollars' worth of shipments push from Q2 to Q3 last year. And with our record quarter last quarter, we pulled probably a somewhat similar amount from Q3 this year into Q2 this year. So that comp has challenged both directions as a result of that. Thinking about Q4, Q4 is actually kind of the opposite of systems in the sense that most of our customers tend to shut down mid-December in terms of receiving new material. So it tends to be a little bit of a lighter quarter on a relative basis. So I'd say that and some more transient timing issues in terms of shipments are really driving what we expect to see in Q4. I think as we go forward from there, it's really, you know, we do continue to expect to see that pull-through number move up. You know, we're working very hard, and Rob talked about Project Rapid kind of moving customers not only through validation but also into routine use of those systems and pulling through the consumables. And we've got kind of the full court press on that front, and that gives us confidence that we'll see that sequential growth pick up again in 24. Okay.
spk03: Okay, if I could sneak one more in here just on gross margins. Do you think the improvement that you see over the next couple of quarters, which I think is something you're looking for, is that going to be driven more by the product side or the services side? And then on gross margin positivity for next year, is the latest thought that you've sort of you cross over to positivity at the end of the year to exit 24, or could that happen sooner?
spk01: Yeah, so I expect improvement to be both product and services. You know, we talked a little bit about productivity and service. There was an improvement, a pretty good improvement this quarter in service, and I think as, you know, I think everything kind of comes from system placements, and as we're getting back on a trajectory now where placements are stepping up, It's going to drive more validation opportunities for us. And the other one that I never lose sight of is service contracts. Almost every month now we have new customers moving into a situation where they need to start buying service contracts from us. So we expect those two things to drive growth in services. And then I talked in the call a bit about products across both systems and consumables. But consumables in particular is an area where we're investing a lot of time and energy. As you know, we did some things on the line over the past couple quarters that we expect to yield benefits starting this quarter. So I'd expect the improvement to come from both areas within the business. I think as you look at what I expect to happen over the coming quarters on margin, I mean, thinking about Q4, we improved 11 percentage points from Q2 to Q3. That's probably not a bad way to think about what we expect to happen based on our outlook at this point. We've also talked about the fact that a couple more system placements getting us up into high single digits could get us to positivity, and I think that's still true. So I'll give you a couple points to triangulate on there relative to Q4 margin expectations. And then if we assume, just for argument's sake, our typical kind of quarterly trend within a year, we typically step down in placements from Q4 to Q1 So that obviously puts some negative pressure on margins. So we'll talk about guidance when we announce Q4, but I would expect that we'll see revenues step down, placements typically step down in Q1, unless we see some other things happening. We'll talk more about that when we give guidance. But if we assume the normal trend, I'd expect that you'd probably be negative in Q1. From there on out, it really depends on the ramp on placements and business activity. So latter part of the year is more likely. Could we get there kind of middle of the year? Possibly. But we'll give you more color on that when we're ready to give you guidance for next year.
spk06: Yep. Okay. I can work with that. Thanks a bunch, guys.
spk07: Sure. Stephen Ma with TD Cowan. Your line is open.
spk02: Great. Thanks for taking the questions. Can you give us an update on the timelines on the rapid sterility offering? It's been in beta testing for some time now. And then also, have you been getting any early inbounds on the rapid sterility offering from either new or existing customers? And can you discuss the impact on how you think about your sales funnel in 2024?
spk05: Yes, Steve, thanks for the question. It's Rob. So we have not given a timeline on rapid sterility. We have mentioned in the past couple calls that we're increasing our focus on commercialization. So we'll let, you know, that should be a bit of an indicator of kind of how we're tracking through the development process. Development's gone well. We're incredibly encouraged in what we're seeing as far as our internally generated data, feedback from our beta customer, and it's given us the opportunity the confidence to focus increasingly on commercialization activities. As I mentioned, we'll have a more significant and robust update for everyone next quarter. And we'll be excited for that discussion. With regard to inbounds, we're not commercially, it's not being commercially marketed currently. So clearly there's, well, There is interest in a rapid sterility offering. We've done meaningful voice-to-customer work and believe we have the right features and benefits and value proposition that this market is looking for, all under the umbrella and aegis of our growth direct system with data integrity and full automation. So we're very excited about the commercial potential for the system, but again, we haven't been marketing it and we're not in that mode right now. But more to follow as we move through time here.
spk02: Okay, yeah, great, thanks for the color. A question actually for Sean now. On the ASPs, it looks like they've normalized in Q3 versus Q2. Maybe you can discuss some of the trends there. And then a question maybe for Rob. you know, do you expect to have to give, you know, multi-system, you know, either promotions or discounts? Is that going to be part of your sales and marketing strategy?
spk01: Yeah. Hi, Steve. It's Sean. Are you talking about systems specifically?
spk02: Yeah.
spk01: Yeah. So I think, you know, and this may lead into Rob's question, so he'll have comments too. Yeah, so I think, you know, we – I wouldn't necessarily tie it directly to multi-system deals, but we obviously look at strategic customers. There are times that we will do certain things for specific customers from a pricing standpoint to either get them on board, kind of get them on the team. That happens with some variability, so that can impact how ASPs move from quarter to quarter. So I would say that's clearly not the norm. We're happy overall with where we are in ASPs this year. And our expectation is we're going to continue to look at opportunities to move them up as we go forward.
spk05: Yes, Steve. So I think as in many markets, with the higher the volume opportunity, the price will be an area of focus. And one of the elements our business is moving through as we become a larger and larger piece of enterprise discussions and enterprise rollout is especially in big pharma. We will engage with the procurement teams and have those discussions about price and volumes. That's in the ordinary course, as Sean touched on, where we watch ASPs carefully and we're happy with where we are and where we're trending with them. And we always endeavor to make sure we're getting paid for the value that we provide. But certainly with larger enterprise rollouts, the pricing is going to be a bit different than a smaller one-off sale for sure.
spk02: Okay, great. Thanks. That's helpful. And if I can sneak one last question. You guys talked a lot about your marketing activities with your demo labs in Germany and in Massachusetts. When I look at your sales and marketing spend, it looks to be relatively flat from 2022. How should we think about sales and marketing OPEX going forward? Is it going to be sort of a steady state or is that going to be increasing?
spk01: Yeah, I think year-over-year comparison, Steve, Q3 last year was a bit of an anomaly. We had a restructuring that we executed on then. A number of things came out of that that were kind of one time. So I'd say where we are now, fully staffed, as Rob mentioned, is more where I'd expect to be. So I think if the comp was impacted by that, we've increased spend kind of on the base organization and activities since last year. And I would think about that as us being fully staffed, and we'll continue to invest in that area, but I wouldn't expect to see large increases in that spend in the near term at this point.
spk02: Okay, great. Thank you.
spk06: Great. Well, thanks for the question, Steve. And thank you all for your time.
spk05: We're going to wrap up the live call now.
spk07: This concludes today's call. We thank you for your participation. You may now disconnect.
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