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DATE

Friday, Aug. 7, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

  • Investor Relations - Michael Beaulieu
  • President and Chief Executive Officer - Robert Spignesi
  • Executive Vice President and Chief Financial Officer - Sean Wirtjes

TAKEAWAYS

  • Revenue -- $8.1 million, growing 10.9% year over year driven by increased consumable pull-through and system validations.
  • Product Revenue -- $5.3 million, an increase of 10.1% year over year reflecting strong consumable growth and system placements.
  • Service Revenue -- $2.8 million, rising 12.5% year over year due to higher validation activity and recurring service contracts.
  • Recurring Revenue -- $5.0 million, representing 14.3% growth year over year and comprising 63% of total revenue.
  • Consumable Revenue -- Increased more than 20% year over year, reaching a new quarterly record for both units and revenue.
  • Gross Margin -- 15.0%, representing a quarterly record and an 11-percentage-point improvement year over year due to cost reduction initiatives and manufacturing efficiencies.
  • Product Margin -- Negative 3%, an 8-percentage-point improvement year over year driven by consumable margin gains.
  • Consumable Margin -- Improved by 17 percentage points year over year reflecting material cost reductions and higher production throughput.
  • Service Margin -- 49%, a record quarterly level representing a 17-percentage-point improvement year over year due to service productivity and higher validation volume.
  • Net Loss -- $12.9 million, or $0.27 per share, compared to a net loss of $11.9 million in the prior year period.
  • Non-GAAP Adjusted EBITDA Loss -- $10.3 million, compared to a loss of $10.1 million in the prior year period as higher margins were offset by nonrecurring corporate expenses.
  • Operating Expenses -- $13.5 million, an increase of 8.9% year over year primarily due to nonrecurring corporate costs.
  • System Placements -- Four Growth Direct Systems were placed during the quarter, reaching a cumulative milestone of 200 systems placed globally.
  • System Validations -- Nine systems were validated in the quarter, with full-year guidance increased to at least 27 validations.
  • Cash and Investments -- Approximately $20 million as of June 30, 2026, including cash, cash equivalents, and short-term investments.
  • Full Year 2026 Revenue Guidance -- Reaffirmed at $37 million to $41 million, assuming 30 to 38 system placements.
  • Q3 2026 Revenue Guidance -- At least $9.5 million, including a minimum of seven system placements.
  • Long-term Revenue Goal -- Average annual growth of greater than 20% over the next several years driven by enterprise deployments and the MilliporeSigma collaboration.
  • Long-term Margin Goal -- Target gross margin of 50% or more exiting 2028 supported by material cost reductions and manufacturing leverage.
  • Efficiency Program -- Targeted actions taken in August 2026 expected to reduce expenses by $1 million in the second half of 2026 and $3 million annually starting in 2027.
  • Debt Tranche Access -- The company expects to achieve milestones to access a $10 million tranche under its Trinity Capital facility later in 2026.

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RISKS

  • Wirtjes noted that cash usage in the first half of 2026 was "exacerbated by 2 temporary working capital headwinds" related to collecting 100% of the cash from 16 system placements in late 2025 during the fourth quarter rather than the following first quarter.
  • Spignesi noted that the collaboration with MilliporeSigma will likely see a delay in fulfillment, stating that "they will not fulfill their full obligation in the calendar year" due to the timing of contract terms.

SUMMARY

Management of Rapid Micro Biosystems, Inc. (RPID -1.18%) reported record gross margins of 15% and reaffirmed full-year revenue targets between $37 million and $41 million. The company emphasized a strategic shift toward multisystem enterprise deployments and highlighted a significant milestone with its 200th Growth Direct system placement. Strategic initiatives focus on scaling the MilliporeSigma partnership, integrating automation into broader customer workflows, and implementing a new efficiency program to reduce annual expenses by $3 million. Management expressed confidence in a pathway to positive cash flow by 2028, supported by recurring consumable growth and a growing pipeline of system validations across North America, Europe, and Asia.

  • CEO Spignesi described the Growth Direct platform as a "critical enabling technology" for manufacturers seeking to integrate microbial quality control into broader automation and digital data strategies.
  • The company expects to ship its 10 millionth consumable in the third quarter of 2026, highlighting the scale of routine use within its installed base of 169 fully validated systems.
  • Management cited encouraging activity in U.S. reshoring and biomanufacturing capacity expansion, which is expected to become an increasingly meaningful contributor to growth beginning in 2027.
  • The collaboration with MilliporeSigma contributed to system placements in the first half of 2026, with management expecting contribution to increase during the second half of the year.
  • Product margin reached negative 3% in the quarter, and management anticipates fourth-quarter gross margin to expand to the mid to high 20% range.
  • CEO Spignesi indicated that the cell and gene therapy market remains a strong growth driver, stating that the "majority of the CAR-T manufacturers are using the Growth Direct System" for its turnaround time and accuracy.
  • The company implemented new real-time performance metrics on its consumable production lines to improve overall equipment effectiveness and directly reduce manufacturing costs.

INDUSTRY GLOSSARY

  • Growth Direct System: The company's flagship automated platform for microbial quality control testing in pharmaceutical manufacturing.
  • MQC: Microbial quality control, the process of testing for bacterial or fungal contamination in healthcare products.
  • LIMS: Laboratory information management systems, software used to manage and store data from laboratory testing.
  • CAR-T: Chimeric antigen receptor T-cell therapy, a specialized form of immunotherapy used to treat certain cancers.
  • OEE: Overall equipment effectiveness, a gold-standard metric for measuring manufacturing productivity and quality.
  • CDMO: Contract Development and Manufacturing Organization, a company that provides manufacturing services to the pharmaceutical industry.

Full Conference Call Transcript

Operator: Good day, and thank you for standing by. Welcome to the Rapid Micro Biosystems Second Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Beaulieu with Investor Relations. Please go ahead, sir.

Michael Beaulieu: Good morning, and thank you for joining the Rapid Micro Biosystems Second Quarter Earnings Call. Joining me on the call are Rob Spignesi, President and Chief Executive Officer; and Sean Wirtjes, Chief Financial Officer. This morning, we issued a press release announcing our second quarter 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, assumptions regarding future financial performance, anticipated future cash usage, statements relating to the company's term loan facility, guidance for 2026, including revenue, expenses, gross margin, system placements and validation activities, expectations for and planned activities related to Rapid Micro's business development and growth, including the expected benefits from our distribution and collaboration agreement with MilliporeSigma, customer interest and adoption of the Growth Direct System and the impact of the Growth Direct system on their businesses and operations and statements regarding the potential impact of general macroeconomic conditions on our business and that of our customers.

Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors, including our ability to meet publicly announced guidance, the impact of our existing and any future indebtedness on our ability to operate our business, our ability to achieve the milestones necessary to access any future tranches under our existing debt facility and to comply with all of its obligations thereunder, our ability to access additional capital, such as through the exercise of our recently issued warrants, our ability to deliver products to customers and recognize revenue and market and macroeconomic conditions.

For a more detailed 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 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. Please note that today's remarks include certain non-GAAP financial measures. These non-GAAP measures should not be considered in isolation or as a substitute for, or superior, to financial information presented in accordance with GAAP.

They are provided as supplemental information to enhance investors' understanding of our operating performance and may differ from similarly titled measures used by other companies. Reconciliations between these non-GAAP measures and the most directly comparable GAAP measures are available in our earnings release issued this morning. We encourage you to review these reconciliations carefully. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 7, 2026. 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.

Robert Spignesi: Good morning, everyone. I'll begin my discussion this morning with a review of our second quarter performance and highlights. I will then discuss our execution against our 2026 full year objectives and share some takeaways from my interactions with customers across North America, Europe and Asia. I will then turn the call over to Sean, who will provide a more detailed review of our second quarter results and second half outlook. Today, we reported Q2 total revenue of $8.1 million, representing 11% year-over-year growth and exceeding the guidance we provided in May. During the quarter, we placed 4 Growth Direct Systems and completed 9 system validations.

I'm also pleased to announce that we achieved a significant milestone during the quarter with the placement of our 200th Growth Direct System. Product revenue increased 10%, driven by more than 20% growth in consumables. Recurring revenue increased 14%, reflecting continued expansion of both our installed base and strong system utilization. Consumable revenue and units reached new quarterly records. And in the third quarter, we expect to ship our 10 millionth consumable, another significant milestone that highlights the growing adoption and routine use of the Growth Direct platform across our customer base. Service revenue increased 13%, driven by higher validation activity year-over-year.

We ended the quarter with 169 fully validated systems globally and have a strong validation pipeline entering second half of the year. This growing validation pipeline provides increasing visibility into future consumable revenue growth and further strengthens the recurring revenue profile of the business. Based on this momentum and our outlook, we are increasing our full year validation guidance to at least 27 systems. Turning to margins. We delivered a record 15% gross margin in the second quarter, reflecting strong execution against our margin expansion strategy. Our first half performance reinforces our confidence in achieving our full year margin targets, and we currently anticipate fourth quarter gross margin in the mid-to-high 20% range.

Now turning to our commercial activities and customer engagement. In June, Amgen hosted our first North America Growth Direct Day, bringing together a strong mix of existing users and prospective customers. As with our prior events, the program featured high-value peer-to-peer discussions focused on the operational, financial and regulatory benefits of automating and standardizing microbial QC. A key theme was how leading biopharma companies approach global Growth Direct deployments, from internal decision-making and cross-functional alignment to implementation, validation and successful operation across multiple sites and geographies. We are grateful to Amgen for hosting the event and sharing their experience as a leading global biopharmaceutical company, including their approach to deploying the Growth Direct across their global manufacturing network.

This marked the second of 3 regional Growth Direct Day events planned for 2026. We will conclude this year's series in October with a European event hosted by Merck MilliporeSigma at its innovation center in Darmstadt, Germany. By making these events regionally accessible, we are enabling a broader group of prospective customers to engage directly with experienced Growth Direct users. In biopharma, peer-to-peer validation remains one of the most effective ways to build confidence, accelerate adoption and advance purchasing decisions. Collectively, these events continue to strengthen both our direct commercial pipeline and the opportunities generated through our collaboration with MilliporeSigma. Following Growth Direct Day, I spent time meeting with customers across North America, Europe and Asia.

I remain highly encouraged by the value proposition of the Growth Direct platform and how it addresses customers' needs. Additionally, what stands out is how these conversations and emerging industry trends continue to evolve. Customers are spending more time discussing how to integrate the Growth Direct platform into broader automation, digital and data enablement strategies and workflows across our manufacturing and quality operations. A consistent message is emerging from these discussions. Manufacturers that can improve speed, consistency, accuracy, data integrity and productivity will create meaningful competitive advantages. Full workflow automation is at the core of these strategies, and in some cases, the Growth Direct is viewed as a critical enabling technology to activate these transformations.

Accordingly, we're increasingly seeing customers focus on broader deployment strategies and more integrated and automated quality of manufacturing systems. We also continue to see encouraging activity related to U.S. reshoring and biomanufacturing capacity expansion, which we believe will become an increasingly meaningful contributor to growth beginning in 2027. Our commercial pipeline continues to expand across all regions, but was especially robust in North America, where strong customer demand and engagement are contributing to the growth of our enterprise deployment and multisystem opportunity funnel. Turning to MilliporeSigma. We remain encouraged by the progress of the partnership. Their commercial organization is active globally, and the opportunity funnel continues to meaningfully expand as they leverage their broad reach and deep customer relationships.

In June, the Rapid Micro and MilliporeSigma leadership teams met in Europe to advance several strategic initiatives supporting the collaboration. In addition to progress on our joint commercial activity, discussions included plans to leverage MilliporeSigma's manufacturing, supply chain and technical expertise to support and accelerate gross margin expansion goals, as well as current and future product innovation opportunities. While we remain in the earlier stages of the partnership, MilliporeSigma contributed to system placements during the first half of 2026, and we expect their contribution to increase meaningfully during the second half of the year and continue into 2027. So, looking ahead, we remain confident in the outlook for Growth Direct placements and revenue growth.

We believe the combination of a compelling customer value proposition, growing system utilization, increasing validation activity, expanding enterprise deployment opportunities, strong demand globally and the growing contribution from MilliporeSigma provide a strong foundation for continued growth. More broadly, we believe the fundamentals of our business are stronger today than at any other point in our history. A growing installed base and higher system utilization are driving record consumable revenue, increasing recurring revenue and improving visibility into future growth. At the same time, our margin expansion initiatives are gaining traction, resulting in a clear positive inflection in gross margins and contributing to a larger and increasingly profitable business.

Importantly, the business today has fundamentally improved from just a few years ago, with a larger installed base, higher recurring revenue, greater margin visibility and broader commercial reach. Additionally, the drivers of our future growth remain firmly in place. Customer engagement remains high. Enterprise deployment discussions continue to expand. Our collaboration with MilliporeSigma is gaining traction, and the industry tailwinds around automation, AI, data integrity, U.S. reshoring and biomanufacturing capacity expansion are accelerating. As we pursue these opportunities, we remain disciplined in our approach to investment, profitability and capital allocation, balancing growth and profitability in a manner that we believe supports long-term shareholder value creation.

Based on our Q2 performance and outlook, we are reaffirming our full year 2026 revenue, placement and gross margin guidance while increasing our full year validation guidance to at least 27 systems. With that, I'll turn the call over to Sean to discuss our second quarter performance and 2026 outlook in more detail. Sean?

Sean Wirtjes: Thanks, Rob, and good morning, everyone. I'll begin with an overview of our second quarter 2026 results, followed by our outlook for the third quarter and full year. We will then open the call for questions. Total revenue for the second quarter increased 11% to $8.1 million compared to $7.3 million in the prior year period. We placed 4 Growth Direct Systems in the quarter. Product revenue, which includes systems and consumables, increased 10% to $5.3 million compared to $4.8 million in Q2 2025. The increase was driven by continued strong consumable growth of more than 20% as new customers move into routine use and existing customers increase the consumable pull-through across their systems.

Service revenue increased 13% to $2.8 million compared to $2.5 million in Q2 2025. We completed 9 validations in the second quarter compared to 2 in the prior year period. Validation activity exceeded our expectations and contributed to stronger-than-expected service revenue growth. Recurring revenue increased 14% to $5 million compared to $4.4 million in Q2 2025. Nonrecurring revenue, which is primarily comprised of systems and validation revenue, was $3 million compared to $2.8 million in the prior year period. Turning to margins. Total second quarter gross margin and gross margin percentage were $1.2 million and 15%, compared to $0.3 million and 4%, respectively, in Q2 last year. This was in line with our guidance.

Within this, Q2 product margin, which includes systems, software and consumables, improved by 8 percentage points to negative 3% compared to negative 11% in Q2 last year. This was slightly below our expectations due to the timing of some software revenue that we now expect in the second half. Consumable margins improved by 17 percentage points year-over-year, reflecting continued progress on our margin expansion initiatives. Q2 service margin was 49% in the second quarter compared to 32% in Q2 last year, also representing a 17-percentage-point improvement and record quarterly margin for our service business. These results were driven by ongoing cost reduction initiatives, manufacturing efficiencies and service productivity improvements across the business as well as operating leverage from higher volumes.

Moving down the P&L. Total operating expenses were $13.5 million in the second quarter compared to $12.4 million in Q2 2025. Within OpEx, R&D expenses were $3.3 million. Sales and marketing expenses were $3.4 million, and G&A expenses were $6.8 million. The increase in OpEx was mainly due to nonrecurring corporate expenses in the period. With respect to non-cash expenses and capital expenditures, depreciation and amortization expense was $0.7 million, and stock-based compensation expense was $1.3 million. Capital expenditures were de minimis in the second quarter. Interest income was $0.1 million and interest expense was $0.6 million in the second quarter.

Q2 net loss was $12.9 million compared to a net loss of $11.9 million in the same period last year. Net loss per share was $0.27 in both periods. Starting this quarter, we are reporting adjusted EBITDA loss, a non-GAAP metric that adjusts our GAAP net loss to exclude interest, taxes and non-cash items, such as depreciation, amortization and stock-based compensation. We believe adjusted EBITDA loss provides investors with a clearer view of the actual cash used by our core operations and the underlying performance of the business.

Adjusted EBITDA loss for the second quarter was $10.3 million, compared to a loss of $10.1 million in Q2 last year, with the positive impact of higher gross margins offset by higher OpEx in the period. In Q3, we expect adjusted EBITDA loss to improve meaningfully from Q2 as gross margins continue to expand and OpEx returns to lower levels similar to those in Q3 last year. We then expect further sequential improvement in Q4. Now I'll turn to our outlook for the third quarter and full year. For the full year 2026, we are reaffirming our total revenue guidance of $37 million to $41 million, which assumes 30 to 38 system placements.

For Q3, we expect revenue of at least $9.5 million, including at least 7 system placements. We continue to expect revenue and system placements to peak in Q4, in line with typical seasonality. Turning to consumables. We expect Q3 revenue to be relatively consistent with Q2 and then increase sequentially in Q4, subject to the timing of customer orders and shipments. Looking at service, we expect service revenue to step up sequentially in Q3 and then again in Q4, based on our current expectations with respect to the timing of installation and validation activities. We now expect to complete at least 27 validations in 2026, with at least 10 in the third quarter. Turning to margin.

We expect our Q3 gross margin percentage to be at least 20%. This assumes product margin in the high-single to low-double digits, including slightly positive consumable margin and service margin approaching 50%. We then expect Q4 margin in the mid- to high-20% range, with sequential expansion compared to Q3 across product and service. These expected improvements reflect the continued realization of material cost reductions, manufacturing and service productivity improvements and operating leverage from higher volumes. For the full year, we expect total gross margin of approximately 20%, product margin in the mid- to high-single digits, and service margin between 45% and 50%.

Importantly, this margin expansion is a key driver of our expectation for significantly lower cash usage in the second half of the year. Continuing down the P&L. For the full year, we now expect operating expenses of between $51 million to $53 million, and $8 million in non-cash expenses, including depreciation and amortization expense of $3 million and stock compensation expense of $5 million. Of the $8 million in non-cash expenses, approximately $7 million is expected to be recorded in OpEx and approximately $1 million in cost of revenue. We also expect CapEx of $1 million, interest income of $1 million and interest expense of $2 million for the full year.

With our 2026 guidance as a starting point, I'd now like to discuss the operating assumptions that support our objective of achieving positive cash flow by the end of 2028. From a revenue perspective, we see multiple growth drivers that should position us to deliver average annual revenue growth of greater than 20% over the next several years.

These include continued expansion within our existing top 20 pharma customers, new customer adoption across both top-tier and core pharma accounts, growing recurring revenue driven by higher system utilization and an expanding installed base, increasing contributions from our collaboration with MilliporeSigma across both core and adjacent markets, and favorable industry trends, including accelerating use of full automation, U.S. reshoring and biomanufacturing capacity expansion. Turning to gross margin. We continue to target gross margin of 50% or more exiting 2028, driven by ongoing material cost reductions, manufacturing efficiencies, service productivity improvements and operating leverage from higher volumes.

While we expect normal quarterly variability and seasonality to continue, we believe our execution to date, visibility into the business, and progress we are making against our growth and margin initiatives support these long-term objectives. Turning to our balance sheet and liquidity. We ended the second quarter with approximately $20 million in cash, cash equivalents and short-term investments. As we discussed in May, we expect cash usage in the second half of the year to decline meaningfully, assuming revenue increases as anticipated, margin continues to expand and working capital trends improve.

As a reminder, cash usage is typically higher in the first half of each year due to normal revenue seasonality and margin improvement trends as well as inventory stocking to support increasing production. In the first half of this year, these factors were exacerbated by 2 temporary working capital headwinds related to the record 16 system placements we made in Q4 2025. First, we collected 100% of the cash from those placements within the fourth quarter last year rather than in Q1 this year as we normally expect. And second, we used more cash than usual to replenish systems inventory in the first half of this year to support our 2026 manufacturing plan.

We don't expect these factors to have a meaningful impact on cash usage in the second half of 2026. Separately, this week, we executed a focused efficiency program designed to streamline certain functions and processes that will reduce employee and other expenses as well as cash usage. We expect these actions to reduce expenses and cash usage by around $1 million over the remainder of this year and approximately $3 million annually beginning in 2027. These actions do not impact our plans to continue to invest in key initiatives that are expected to drive future revenue growth and gross margin expansion, including customer sales and support, product development and product cost reduction programs.

Combined with our revenue growth and margin expansion initiatives, these actions further support our expectation for meaningfully lower cash usage in the second half of 2026 and beyond. Looking forward, based on our current operating performance and outlook, we believe we are on track to achieve the milestones necessary to access the next $10 million tranche under our debt facility with Trinity Capital later this year, with another $10 million tranche potentially available to us in mid-2027, subject to achievement of the applicable milestones. In addition, the warrants issued in connection with our May financing would provide incremental capital if exercised.

Based on our outlook for continued revenue growth, margin expansion and meaningfully declining cash usage, we believe our existing liquidity and access to additional capital sources supports a pathway to positive cash flow. Looking ahead, we plan to maintain our proactive approach to balance sheet management and disciplined capital allocation while also evaluating opportunities to enhance financial flexibility and maximize long-term shareholder value. That concludes my remarks. So at this point, we'll open the call up for questions. Operator?

Operator: [Operator Instructions] Our first question is going to come from the line of Thomas Flaten with Lake Street Capital Markets.

Thomas Flaten: Congrats on the quarter and all the progress. Just a couple of quick questions. Rob, you mentioned you had some pretty positive commentary coming out of your meeting with the Merck MilliporeSigma folks, including having them contribute more meaningfully in the second half. If I remember though, from the past commentary, one of the reasons that you had the low end of guidance was because that was kind of assumed that they weren't going to be contributing. So can you walk us through the positive commentary and then not raising the bottom of the guidance range? Just kind of fill us in there if there's other caveats that at least I'm missing.

Robert Spignesi: Yes. So first, for context, we met with the Merck MilliporeSigma team to do a strategic review of where we are across all our initiatives, not only commercial, but supply chain/gross margin improvement and technology. And we have another one follow-up in the U.S. coming up. So just in general, I'm incredibly encouraged with where the relationship is between the companies and how it's tracking. The low end of our guide did not include the full allocation of the Merck commitment for the year. That being said, what we do expect is a meaningfully increased contribution from Merck Millipore in the second half.

They will not fulfill their full obligation in the calendar year, as we previously said, just given how the contract falls, it's possible they will. But the current anticipation is a meaningfully strong increase from where they were in the first half. And as I mentioned, they did contribute in the first half, but we expect it to accelerate meaningfully in the second half. And that's one of the elements that underpins our confidence in the second half and the reaffirmation of our guide.

Thomas Flaten: Got it. And then I don't know if you can characterize this, perhaps only qualitatively. As you look at the placements that you have made this year and the ones that you're projecting for the second half of the year, could you help us understand of those placements, what's breadth versus depth within your customers? How many new customers versus deepening your relationships with existing customers?

Robert Spignesi: Yes. So usually, I don't have the exact detail in front of me, but we always have a bias towards existing customers, as you may imagine. So just for a reminder, our land and expand strategy continues to be quite effective, where we land with a customer and then those customers expand. And that expansion can take multiple different forms. As I mentioned before, it could be within existing sites, it can be new sites, it could be new applications. So there's no real hard rule there, which we find as attractive because it doesn't limit us to kind of a single-threaded expansion.

So the majority come from our existing customer base, but there are new customers most periods as well. And as we watch the MilliporeSigma funnel increase, we're also seeing an increase, as you may imagine, in new customers. So the portfolio as it's coming together and as we look into the second half and into 2027, we like what we see with regard to not only the trends I touched on in my remarks, but also how the actual funnels are building new and existing multi-system and also geographically. So we've got good geographic representation.

And then, of course, the MilliporeSigma collaboration is starting to open up new geographies for us within pharmaceutical manufacturing and quality control and even some adjacent markets, although the bias is currently pharma globally.

Sean Wirtjes: Yes. And I think one of the exciting things, Thomas, when you look out over the next several quarters on our funnel, there are a number of potential new customers with multi-system deals right out of the gate. So those are things we're looking for, and we're seeing some of that potential in that funnel.

Robert Spignesi: And that's the evolution of the business, and we go long here, but I think it's important to Sean's point, we're seeing new customers kind of jump out with more than one system. And that's telling us and the conversations that we're having with customers reinforce this that the technology is becoming more of a standard in a lot of ways and customers are seeing the benefit, and we're moving into what we expect to be a new phase of market development, which is very exciting.

Operator: Our next question is going to come from the line of Dan Arias with Stifel.

Daniel Arias: Sean, can you just maybe talk a little bit about consumables growth and how you're seeing that for the back half of the year? It was, I believe, 30% last quarter, 20% this quarter. In my model, you step up a little bit from 2Q to 3Q in terms of dollars. So, I'm just curious how you would have us think about growth levels in the back half of the year there?

Sean Wirtjes: Yes. Sure, Dan. Comps are a little tougher in the second half. I talked in my remarks about we expect to be relatively flat from Q2 to Q3 sequentially, but still, this quarter was a record quarter. So, it's maintaining that, and we'll work to drive some upside to that, but the guide is to be relatively flat and then stepping up sequentially in Q4. So, I think we expect to see good growth in the second half, too. We have historically talked from time to time about pull-through. I think if you look at Q2 pull-through, the year-over-year is high-single-digit growth if you look at it per validated system.

So that is going well for us, and that can vary from quarter to quarter. But I think overall, if you look at what we expect for the year, it would look something like that. So we feel -- we're pretty good about where consumables and consumables growth are right now, and customers are continuing to both come online in terms of new customers that are getting validated and into routine use and existing customers continuing to put their systems to higher use.

Daniel Arias: Okay. Helpful. And then just on the gross margin line, I know that the model will benefit from just some of the mechanical things that you have going for you. But can you just maybe sort of crystallize the things that on your end, you need to do most in order to have this trajectory land where it needs to be by the end of the year? And then obviously, we'll talk, I'm sure, about next year in a quarter or 2. But, just given that you're finishing the year so much higher than you were at the beginning of the year, can you maybe talk about upside scenarios for gross margins next year?

Is it at least fair to model gross margins up a little bit next year?

Sean Wirtjes: Yes. I mean, I'll start with that. Yes. We talked about the goal of getting to 50% exiting 2028. So that's got to -- we've got to continue to make progress every quarter effectively. Yes, so that is the plan. If I go down, kind of, the primary product and service lines, in systems, we have some things that are in flight from a material cost reduction standpoint that we need to execute against that will drive most of the margin improvement there from a cost down standpoint. In consumables, we're continuing to drive to get throughput continually increasing over time. The line is -- we're getting more and more efficient with the line.

The line is putting more and more product through. Consistency is getting better and better. So we've got to continue to execute against that to hit our numbers in terms of margins on consumables. And then service, we -- I think we've said we have pretty good visibility into an increased level of validation activity, in particular, in the second half. And a lot of that's driven by volume. I'd say the vast majority of the margin expansion in the second half in service is driven by just pure revenue volume. So, those would be the key ones.

The other one, volume does matter both in terms of what we're selling and, obviously, what we produce to meet that demand in both systems and consumables, as well. So, that's also something that we -- if that were to change, that might have some impact up or down on margins. So that's another factor you should keep in mind.

Robert Spignesi: And, Dan, it's Rob. One thing, too, to help the efficiency on the consumable lines, we've implemented a new technology on the line that gives management and operators real-time and near real-time performance metrics and the ability to spot any diversions quite quickly. So, that's also helping what we call the OEE, which is essentially the throughput and quality of the system, which is also directly benefiting efficiencies and costs as well.

Daniel Arias: All right. Helpful, Rob. Sorry, Sean, just one more point of clarification on the way that I asked the question, obviously, gross margins will be up next year-over-year, but do you think gross margins can be up from where you're exiting the year in 2026? Because obviously, to get to 50% by 2028, to your point, you kind of need to be working higher. But I just wanted to get you to sign on to the idea that you might end up in high-20s in 4Q and then drop down to 20% or something like that and then have another ramp.

Sean Wirtjes: It's a good point. I mean you got to keep typical quarterly seasonality in mind. But, yes, the 2027 gross margin, we expect it to be higher than the exit rate for 2026.

Operator: Our next question will come from the line of Brendan Smith with TD Cowen.

Brendan Smith: Just a couple of quick ones from us. I guess, first, can you actually speak a bit more kind of to the customer breakdown now so far this year? Any kind of particular trends you're seeing with suite replacing new systems with any visibility into maybe how that evolves or doesn't in the second half? Kind of just wondering what that mix of biotech, pharma, CDMOs, et cetera, placements may be looking like and how that could impact kind of the potential for multisystem orders?

Robert Spignesi: Yes. So, as mentioned, Brendan, the general breakdown, first half generally included -- tends to be biased towards our existing customers, but do include new customers. We expect to see something similar in the back half. We are seeing some interesting trends in our CDMOs, as you mentioned, in particular. We're starting to see significant interest in more fully automated integrated systems. As I touched on in my remarks, this seems to be a trend that's primarily impacting CDMOs, we're also seeing some strong interest in our large existing customers as well. So what the bias is -- the underlying bias seems to be a focus on more integration sooner rather than later.

And given that our system is the only fully automated system out there, it can integrate into other technologies quite readily in many cases. So that's also driving, I would say, potential demand in the second half of this year and going into 2027 as well. So that will be a new trend that's emerging that would likely impact the CDMO businesses for the principal manufacturers. We'll see how it turns out, but that's -- it's the leading edge of that. It's quite interesting. But generally, what we expect is a balanced placement trajectory, sales and placement trajectory across our principal regions of North America, Europe and Asia.

I would say, increasingly flattered by contribution from Merck MilliporeSigma in a, new customers, b, sites of our existing customer base that we just haven't had access to. And then I would say, c, new geographies around the world, for example, South America, parts of Asia, et cetera. So over time, I see that portfolio balancing more and basically filling in the areas of the world and the segments that we are underrepresented right now.

Brendan Smith: Got it. Makes sense. Okay. That's helpful. And then maybe separately, I wanted to actually ask just a bit more about some of the customer feedback kind of on the U.S. onshoring dynamics. I know you mentioned it's playing more role next year. But I guess any more granularity maybe there, either on timing or even just some of the build-out versus ordering versus kind of revenue recognition dynamics in that process that we should be aware of just as we kind of think about the potential impact over the next 18 months?

Robert Spignesi: Yes. So, it's -- I know there's been a lot of headline announcements of the reshoring. I can't speak to whether it's all happening and kind of the timing is happening. But we are aware of within our customer base, certainly a portion of it happening because we've been contacted about getting ahead of that with regard to placements of Growth Direct Systems, more than likely starting in 2027. Probably say at this point, mid- to late '27, based on how things are moving and just the pacing of the timing of the various projects.

So while we're not pounding the table now it's definitive, it looks constructive that we will benefit from some reshoring starting in 2027 and perhaps accelerating in '28 and '29. It's really hard to tell how fast things will ultimately move, but the trends and the conversations and in some cases, the actual shovels in the ground that we're able to see are actually happening. So, it's certainly, to a certain extent, real, and we expect to benefit from it.

Operator: [Operator Instructions] And our next question is going to come from the line of Anna Snopkowski with KeyBanc.

Anna Snopkowski: This is Anna Snopkowski on for Paul Knight. Congrats on the quarter. Maybe first, a follow-up on Dan's question about gross margins. Could you just talk to the visibility you have in the back half and whether any procurement or sourcing initiatives under Millipore have already been implemented and are contributing to that outlook or if that's a longer-term runway?

Sean Wirtjes: Yes. Sean, Anna. In addition to what I walked through in response to Dan's question in terms of key drivers in the second half, I think that stands. We are actively talking to MilliporeSigma about several different things on the procurement side, but I do not expect them to be significant contributors in the second half. I would think about that more in 2027. Just as we've talked about before, getting a material validated and to a point where we can actually use it in our products, for example, takes time, and we're working through that time.

But those projects are ongoing, but we are not at the point where we can start to use them in any meaningful way in 2026. So I think about that more as a [ 2027 ] event.

Anna Snopkowski: Okay. Makes sense. And then my second question is just on the CAR-T market. That seems to be very strong. Carvykti had a good quarter. And then, I think yesterday, Iovance had a really strong print. So could you just tell us what you're seeing on that side of the market and remind us your involvement on the cell and gene therapy side of the market?

Robert Spignesi: Yes. So it's Rob. So cell and gene, well, our value prop resonates quite strongly in cell and gene market, as we've said previously, and it's extremely strong in the CAR-T market. The majority of the CAR-T manufacturers are using the Growth Direct System. It's a very strong fit regarding the turnaround time. Just to remind everyone why we're so strong, there's the speed, the test result, time to test result, the automation, the volume, the accuracy required. The Growth Direct System is an extremely strong fit in our view for cell and gene broadly and CAR-T, in particular. You saw our consumable performance, in part, that is due to the cell and gene market and CAR-T, as well.

So, from our perspective, the market is healthy. The manufacturers continue to see ROI and use our systems for CAR-T manufacturing robustly and, in some cases, at an increased rate, reflecting their business. Thank you, Anna, and everyone on the call. We're going to wrap today's call. Thank you all for joining us. Look forward to speaking with many of you soon. Have a great weekend.

Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.