RAPID MICRO BIOSYSTEMS, INC.
For the period ended Mar 31, 2026. Filed May 15, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 15, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-07.
0001380106-25-000200
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001380106-26-000075
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 155 previous paragraphs and 140 current paragraphs.
61 unchanged; 46 reworded; 32 added; 46 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 14 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (32)
Current report
MilliporeSigma partnership
Current report
We have made significant investments to build infrastructure and develop capabilities in areas such as procurement, manufacturing, distribution, quality and after-sales service. Given our current business scale, our revenues are not yet sufficient to fully cover these costs, impacting our current gross margin profile. For additional information, see Item 1. Business - Gross margin improvement included in our Annual Report on Form 10-K.
Current report
We have experienced positive trends in gross margin percentage, improving from (24.4)% to (0.4)% to 3.1% for the years ended December 31, 2023, 2024 and 2025, respectively, and to 4.6% for the three months ended March 31, 2026. While we expect our gross margin percentage to continue to trend positively in the future, expansion in future periods maynot be linear and may be subject to variability from period to period.
Current report
LIMS connection and other software
Current report
We also offer other software to our customers for use with our Growth Direct platform that adds features or expands capabilities, such as our Mold Alarm software.
Current report
To the extent our sales of Growth Direct systems increase in future periods, we would also expect LIMS connection and other software revenue to increase.
Current report
Cost of revenue, gross margin, and gross margin percentage
Current report
Gross margin is calculated as revenue less cost of revenue. Gross margin percentage is gross margin expressed as a percentage of revenue. Our gross margin in future periods will depend on a variety of factors, including market conditions that may impact our pricing, sales mix among systems, consumables, and services, excess and obsolete inventories, our cost structure for manufacturing operations relative to volume, and product warranty obligations.
Current report
Operating expenses
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Research and development
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Sales and marketing
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General and administrative
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Other income (expense)
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Interest income
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Interest expense
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Other expense, net
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Product revenue increased by $1.5 million, or 36.0%, with the increase primarily attributable to an increase in system placements as well as higher consumable shipment volumes due mainly to an increase in cumulative validated systems.
Current report
Cost of revenue, gross margin, and gross margin percentage
Current report
Cost of product revenue increased by $1.0 million, or 19.8%. The increase was driven by higher system and consumables sales volume, as well as an unfavorable mix impact of products sold, namely a higher rate of growth in consumables as compared to systems. This increase was partially offset by a reduction in the costs to manufacture our products.
Current report
Gross margin and gross margin percentage remained relatively flat between periods. There was an improvement in product margin, which was offset by a decrease in service margin.
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Operating expenses
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Research and development
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Sales and marketing
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General and administrative
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Other income (expense)
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Interest income
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Interest expense
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Other expense, net
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ATM facility
Current report
On December 15, 2023, we entered into a sales agreement to establish an ATM facility with Cowen and Company, LLC, pursuant to which we may sell and issue shares of our Class A common stock. During the quarter and year ended December 31, 2025, we sold 113,217 shares of Class A common stock under this facility resulting in net proceeds of $0.4 million. During the quarter ended March 31, 2026, we did not issue or sell any shares of our Class A common stock under this facility.
Current report
For additional information on our contractual obligation and commitments please see Note 15 —Commitments and Contingencies to our consolidated financial statements.
Current report
Critical accounting policies and significant judgments and estimates
Removed paragraphs (46)
Previous report
•growing sales of our products in both the United States and international markets by further expanding our sales and marketing capabilities;
Previous report
•scaling our manufacturing and supply chain processes and infrastructure to meet growing demand for our products;
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•investing in research and development to develop new products and further enhance our existing products;
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•protecting and building on our intellectual property portfolio; and
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•attracting, hiring and retaining qualified personnel.
Previous report
Distribution and Collaboration Agreement
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Loan and Security Agreement
Previous report
On August 8, 2025 (the “Closing Date”), we entered into a Loan and Security Agreement (the “LSA”) with the lenders party thereto (the “Lenders”) and Trinity Capital Inc., as administrative agent and collateral agent (the “Agent”).
Previous report
Under the LSA, the Lenders agreed to extend debt capital to us, in the form of a term loan, in tranches totaling an aggregate principal amount of up to $45.0 million available as follows: (a) at closing, an aggregate principal amount of $20.0 million (the “First Tranche”), (b) until January 31, 2027, subject to the achievement of certain commercial and operational milestones, an aggregate principal amount of $10.0 million (the “Second Tranche”), (c) until July 31, 2027, subject to the achievement of certain commercial and operational milestones, an aggregate principal amount of $10.0 million (the “Third Tranche”), and (d) an aggregate principal amount of $5.0 million in Lenders’ sole discretion (the “Fourth Tranche” and collectively with the First Tranche, the Second Tranche and the Third Tranche, the “Tranches”). The obligations of the Lenders to extend such debt capital are subject to certain conditions precedent described in the LSA. We are required to pay a commitment fee of 1.0% of the amount drawn, plus related documentation and funding fees, in connection with each drawdown. On the Closing Date, we drew down the First Tranche. Our obligations under the facility may be guaranteed by certain subsidiaries and are secured by a first priority security interest in substantially all assets of ours and any subsidiaries providing a guarantee.
Previous report
In connection with the drawdown of any Tranche, we are required to issue to the Lenders a warrant to purchase shares of our Class A common stock (the “Common Stock”). The exercise price (“Exercise Price”) for each warrant shall be equal to the lower of (a) the volume-weighted average price of the Common Stock over the ten days prior to the drawdown and (b) the closing price of the Common Stock on the day immediately prior to the drawdown. The number of shares of Common Stock for which each warrant is exercisable is equal to 3.0% of the drawn down amount of the applicable Tranche, divided by the Exercise Price. Each warrant shall have a term of ten years from the date of issuance and shall permit cashless exercise, all in accordance with its terms. In connection with the drawdown of the First Tranche, we issued warrants to purchase up to an aggregate of 179,104 shares of Common Stock, with an Exercise Price of $3.35 per share.
Previous report
All Tranches will mature on September 1, 2030 (the “Maturity Date”), unless earlier accelerated under the terms of the LSA. At maturity, we are required to repay the then-outstanding principal amount, together with any accrued and unpaid interest thereon and any other obligations outstanding under the LSA. In addition, at maturity or early termination of the LSA, including acceleration of the loans, we are required to pay the Lenders an additional 4.0% of the amounts drawn down by us under the LSA (the "End of Term Payment").
Previous report
Interest accrues on the Tranches that we have drawn down at a floating rate per annum, calculated based on a 360-day year, equal to the greater of (a) the sum of (i) The Wall Street Journal Prime Rate and (ii) 4.0%, and (b) 11.0%. The initial interest rate is 11.5% per annum. For the first 36 months after the Closing Date (the “Interest Only Period”), we are required to make only monthly payments of interest in arrears. Following such period, and until the Maturity Date (the “Amortization Period”), we are required to make monthly payments of principal and interest in an amount that fully amortizes the outstanding principal balance due over the duration of the Amortization Period. If the Second Tranche is fully drawn down by us, the Interest Only Period will be extended by six months. If the Third Tranche is fully drawn down by us, the Interest Only Period will be extended by a further six months. In the event of such extensions of the Interest Only Period, the duration of the Amortization Period will decrease by the same amount. In any event, the total term of all Tranches shall not exceed 60 months.
Previous report
We may voluntarily prepay the outstanding loan balance at any time, in whole or in part, subject to the payment of prepayment premiums. If prepayment occurs on or before the first anniversary of the Closing Date, the premium shall equal 3.0% of the principal being repaid. Thereafter, if prepayment occurs on or before the second anniversary of the Closing Date, the premium shall equal 2.0% of the principal being repaid. Thereafter, the premium shall equal 1.0% of the principal being repaid. For the avoidance of doubt, such prepayment premiums are in addition to the End of Term Payment. Additionally, we are required to prepay the outstanding loan balance (plus accrued and unpaid interest thereon, any prepayment premiums and any other obligations that are due and payable) upon a sale, divestment or transfer of all or substantially all assets of our company's, taken as a whole, or of a material business line of our company's, the acquisition by a person or group of a sufficient number of our equity securities to elect a majority of the members of our board of directors, or the acceleration of the loans by the Agent on behalf of the Lenders following an event of default under the LSA.
Previous report
The LSA contains customary affirmative and negative covenants, including with respect to notice obligations, limitations on new indebtedness, liens, investments and transactions with affiliates of ours, restrictions on the payment of dividends, maintenance of collateral and accounts and maintenance of insurance. The LSA does not contain any covenants to maintain a specified level of revenues, profitability, cash flow or cash resources.
Previous report
The LSA contains our customary representations and warranties, as well as customary events of default, the occurrence of which may accelerate our obligations, increase the interest rate by a specified default rate and impose other consequences described in the LSA. Such events include among others, failure to make payments when due, breach of covenants, insolvency, a cross-default to other indebtedness, a judgment event of default, the occurrence of a material adverse change to our operations, and delisting of our securities from the Nasdaq Stock Market LLC.
Previous report
Effects of inflation and interest rates
Previous report
The current inflationary and interest rate environment could have a negative impact on our results of operations, cash flows and overall financial condition. The widespread use of tariffs may have an inflationary effect on the prices of goods and services, including those that we utilize in the production of our products and delivery of our services. As a result, due to tariffs and other macroeconomic factors, we have and may continue to experience inflationary pressures on significant cost categories including labor, materials and freight. We continue to monitor the impact of inflation on these costs in order to minimize its effects through productivity improvements and cost reductions. There can be no assurance, however, that our operating results will not be affected by inflation in the future. In addition, inflation and increased interest rates (or the impact on the broader macroeconomic environment resulting from the foregoing) may decrease demand for our Growth Direct systems, as our customers may face economic uncertainty as a result. A decrease in demand for our products or increases in our costs, as well as any steps we may take to mitigate changes, could impact our overall growth. However, the related financial impact cannot be reasonably estimated at this time.
Previous report
Innovating and launching new products on the Growth Direct platform
Previous report
We believe the depth, scalability and robust capabilities of our Growth Direct platform allow us to address key opportunities and challenges facing MQC testing in the pharmaceutical industry. As an innovative leader in automated MQC testing, we intend to invest in further enhancements in our existing Growth Direct platform as well as end-to-end workflow solutions in our core market. We plan to further invest in research and development to support the expansion of our Growth Direct platform through development and launch of new applications to capture greater share of customer testing volume, new product formats to broaden our ability to serve different market segments and launch of new products and technologies to address adjacent segments of the overall MQC workflow. We plan to continue to hire employees with the necessary scientific and technical backgrounds to enhance our existing products and help us introduce new products to market. We expect to incur additional research and development expenses as a result. By expanding and continuously enhancing the Growth Direct platform, we believe we can drive incremental revenue from existing clients as well as broaden the appeal of our solutions to potential new customers.
Previous report
We made the Growth Direct Rapid Sterility application available for commercial sale and placed the first Rapid Sterility system at one of our existing customers in the second quarter of 2024. We plan to continue efforts to scale our manufacturing capabilities for the Rapid Sterility application.
Previous report
The majority of our customers are large, global pharmaceutical manufacturers and contract development and manufacturing organizations. In order to meet the expectations of our customers, we have made significant investments to build infrastructure and develop capabilities in areas such as procurement, manufacturing, distribution, quality and after-sales service. Since the third quarter of 2024, when we achieved positive gross margins for the first time in our company's history, we have maintained positive gross margins each quarter. Maintaining these positive gross margins in future periods will depend on our ability to execute on our business objectives, including generating sufficient revenues to cover the costs of producing and delivering our products and services. In order to further grow our gross margins, we are actively targeting numerous areas including:
Previous report
•Reducing system and consumable product costs (materials and labor) through activities including strategic sourcing and product redesign;
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•Increasing product manufacturing efficiency through activities including increased throughput on our automated consumables manufacturing line and manufacturing process optimization;
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•Increasing achieved pricing of our existing products and services; and
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•Introducing and expanding new, higher margin products and services.
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Software
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Our Mold Alarm software is a recurring or non-recurring product revenue stream depending on the type of software license purchased. Mold Alarm is an optional software module that offers additional functionality by allowing the Growth Direct to distinguish between mold and non-mold growth. Early detection of molds, in as little as 24 hours, allows facilities to begin remediation efforts earlier and return to routine production sooner. This software allows investigations to begin within one day with automated alerts triggered by detection of molds during the early stages of incubation.
Previous report
In July 2024, we completed an enterprise-wide review of opportunities to realize operational efficiencies. Based on the results of this review, we implemented in August 2024 certain actions to reduce costs and expenses across the business (collectively, the "Operational Efficiency Program"). As part of our Operational Efficiency Program, we implemented actions to reduce employee-related expenses and certain other non-employee related costs. The reduced headcount and lower labor costs reflected in costs of revenue and the operating expense categories below was the result of the Operational Efficiency Program announced in August 2024. Our headcount at the end of the third quarter of 2025 was lower than our headcount at the end of the third quarter of 2024.
Previous report
Product revenue decreased by less than $0.1 million, or 0.8%, with the decrease attributable to two fewer system placements offset by higher consumable volumes and higher software revenue.
Previous report
Service revenue increased by $0.3 million, or 11.7%. The increase in service revenue was primarily due to higher revenue related to validations as well as service contract revenue due to an increase in the cumulative number of Growth Direct systems validated and under such contracts.
Previous report
Cost of product revenue increased by $0.2 million, or 4.7%. The increase was driven by higher consumables sales volume, net of the impact of two fewer system placements.
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Research and development expenses decreased by $0.1 million, or 2.2%. This decrease was primarily driven by reduction in headcount and was partially offset by increase in engineering and development work related to new product development activities.
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General and administrative expenses were essentially flat in the third quarter.
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Interest income includes interest earned on our cash equivalents and investments. The $0.4 million, or 55.5%, change in interest income was primarily due to the higher investment in the prior period.
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Interest expense includes interest incurred in connection with our long term debt. The $0.4 million, or 3,472.7%, due to interest incurred with our long term debt.
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Comparison of the nine months ended September 30, 2025 and 2024
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Revenue
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Product revenue increased by $0.6 million, or 4.5%. The increase was driven primarily by a higher volume of consumables as well as an increase in the average selling price of our systems. Higher system-related revenue, particularly from software sales, also contributed to the increase. The increase from these factors was partially offset by three fewer system placements during the nine months ended September 30, 2025 compared to the same period in 2024.
Previous report
Cost of product revenue increased $0.5 million, or 3.3%. The increase was driven by higher consumables sales volume (net of the impact of three fewer system placements) as well as higher inventory reserves in the current-year period.
Previous report
Cost of service revenue decreased by $0.5 million, or 9.0%. This decrease was primarily attributable to lower headcount and related costs due in part to productivity improvements.
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Reworded paragraphs (46)
Previous wording
Since our inception, we have incurred net losses in each year. We generated revenue of $7.8 million and $7.6 million for the three months ended September 30, 2025 and 2024, respectively, and incurred net losses of $11.5 million and $11.3 million for those same periods, respectively. As of September 30, 2025, we had an accumulated deficit of $509.9 million. We expect to continue to incur net losses in connection with our ongoing activities, including:
Current wording
We generated revenue of $8.0 million and $7.2 million for the three months ended March 31, 2026 and 2025, respectively, and incurred net losses of $14.3 million and $11.3 million for those same periods, respectively.
Previous wording
We believe that our cash, cash equivalents and investments as of September 30, 2025 enable us to fund our operating expenses and capital expenditure requirements for at least 12 months following the issuance date of the unaudited interim condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources.”
Current wording
We believe that our cash, cash equivalents and investments as of March 31, 2026 and additional borrowing capacity expected to become under the LSA that is subject to the satisfaction of certain commercial and operational milestones and other conditions later this year enable us to fund our operating expenses and capital expenditure requirements for at least 12 months following the issuance date of the unaudited interim condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources.”
Previous wording
In February 2025, we entered into a Distribution and Collaboration Agreement (the “Distribution Agreement”) with Millipore S.A.S., a subsidiary of the Life Science business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. as MilliporeSigma ("MilliporeSigma”). Pursuant to the Distribution Agreement, we granted MilliporeSigma a global, co-exclusive right to sell our products, initially consisting of our Growth Direct systems and related consumables, into all fields related to industrial quality control applications in the pharmaceutical, medical device, personal care, cosmetics and food and beverage spaces in all regions of the world. During the term of the Distribution Agreement, MilliporeSigma will receive tier-based transfer pricing on such products. We will continue to directly market, sell, manufacture and distribute our products and provide all services to customers, including in respect of system installation, validation, maintenance and support.
Current wording
U.S. as MilliporeSigma ("MilliporeSigma”). Pursuant to the Distribution Agreement, we granted MilliporeSigma a global, co-exclusive right to sell our products, initially consisting of our Growth Direct systems and related consumables, into all fields related to industrial quality control applications in the pharmaceutical, medical device, personal care, cosmetics and food and beverage spaces in all regions of the world. During the term of the Distribution Agreement, MilliporeSigma will receive tier-based transfer pricing on such products. We will continue to directly market, sell, manufacture and distribute our products and provide all services to customers, including in respect of system installation, validation, maintenance and support.
Previous wording
Over the first two years of the Distribution Agreement, MilliporeSigma has committed to purchase a minimum number of Growth Direct systems. Thereafter, our company and MilliporeSigma will evaluate and mutually agree on additional purchase commitments, if any. Pursuant to the Distribution Agreement, we are permitted to continue to sell its products independently and through its existing distributors, but we may not grant the right to sell the products covered by the Distribution Agreement to other third parties so long as a purchase commitment by MilliporeSigma is in place. The initial term of the Distribution Agreement is five years, unless earlier terminated by our company or MilliporeSigma in accordance with its terms.
Current wording
Over the first two years of the Distribution Agreement, MilliporeSigma has committed to purchase a minimum number of Growth Direct systems. Thereafter, we and MilliporeSigma will evaluate and mutually agree on additional purchase commitments, if any. Pursuant to the Distribution Agreement, we are permitted to continue to sell our products independently and through our existing distributors, but we may not grant the right to sell the products covered by the Distribution Agreement to other third parties so long as a purchase commitment by MilliporeSigma is in place. The initial term of the Distribution Agreement is five years, unless earlier terminated by us or MilliporeSigma in accordance with its terms.
Previous wording
The Distribution Agreement also contemplates future collaboration by the parties, including with respect to sourcing materials and service delivery. In that regard, the parties are negotiating towards a supply agreement, pursuant to which the parties will explore cost-saving measures within our supply chain focused on accelerating gross margin improvement, particularly with respect to consumables. The focus of such supply agreement may include raw materials and components as well as manufacturing and supply chain services. The parties intend to share in any cost savings achieved in the supply of the products through this supply agreement. Additionally, within one year, the parties intend to negotiate in good faith towards a services agreement to permit our company and MilliporeSigma to provide certain services to each other’s customers. The parties also intend to explore additional opportunities for collaboration, such as joint development efforts for the enhancement of our products or introducing new products to be covered by the distribution arrangement. At this time, an estimate of the impact of the Distribution Agreement on our financial statements cannot be made. However, we do expect to make incremental investments in our manufacturing and service organizations over time to support increased sales volumes related to the Distribution Agreement.
Current wording
The Distribution Agreement also contemplates future collaboration by the parties, including with respect to sourcing materials and service delivery. In that regard, the parties are negotiating towards a supply agreement, pursuant to which the parties are exploring cost-saving measures within our supply chain focused on accelerating gross margin improvement, particularly with respect to consumables. The focus of such supply agreement may include raw materials and components as well as manufacturing and supply chain services. The parties intend to share in any cost savings achieved in the supply of the products through this supply agreement. Additionally, the parties have signed a services agreement which permits MilliporeSigma to engage us to provide certain of our services to their customers. The parties also intend to explore additional opportunities for collaboration, such as joint development efforts for the enhancement of our products or introducing new products to be covered by the distribution arrangement. We expect to make incremental investments in our manufacturing and service organizations as our sales volumes increase over time, including as a result of increased sales volumes related to the Distribution Agreement.
Previous wording
We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by multiple factors as described below, each of which presents growth opportunities for our business. Our ability to successfully address these challenges is subject to various risks and uncertainties, including those described under the section titled “Risk Factors” to this Quarterly Report on Form 10-Q.
Current wording
We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by multiple factors as described below, each of which presents growth opportunities and challenges for our business. Our ability to successfully address these opportunities and challenges is subject to various risks and uncertainties, including those described under the heading “Risk Factors.”
Previous wording
There is an opportunity to broaden adoption and increase utilization of our Growth Direct platform throughout our existing customers' organizations as these customers purchase more systems. These additional systems will allow our existing customers to convert more of their test volume at existing locations, to support multiple locations, to meet redundancy requirements, or to increase capacity. As of September 30, 2025, approximately 40% of our customers have purchased Growth Direct systems for multiple sites, and approximately 60% of our customers have purchased multiple Growth Direct systems. Increased utilization amongst existing customers can also occur as customers advance through the Growth Direct platform adoption cycle, from early validation of initial applications to validation and conversion of multiple applications on the Growth Direct platform, or as the result of new product approvals or increases in their manufacturing volumes for existing products.
Current wording
There is an opportunity to broaden adoption and increase utilization of our Growth Direct platform throughout our existing customers' organizations as our existing customers purchase more systems. These additional systems will allow our existing customers to convert more of their test volume at existing locations, to support multiple locations, to meet redundancy requirements, or to increase capacity. As of March 31, 2026, over 40% of our customers have purchased Growth Direct systems for multiple sites, and nearly 60% of our customers have purchased multiple Growth Direct systems. Increased utilization amongst existing customers can also occur as customers advance through the Growth Direct platform adoption cycle, from early validation of initial applications to validation and conversion of multiple applications on the Growth Direct platform, or as the result of new product approvals or increases in their manufacturing volumes for existing products.
Previous wording
Our revenue is derived from sales of our Growth Direct systems, our LIMS connection and Mold Alarm software, proprietary consumables, and services. Growth Direct system revenue involves a capital selling process and tends to be somewhat concentrated within a relatively small (but varied) group of customers each year, so it is subject to variability from quarter to quarter.
Current wording
Our revenue is derived from sales of our Growth Direct systems, our LIMS connection and other software, proprietary consumables, and services. Growth Direct system revenue involves a capital selling process and tends to be somewhat concentrated within a relatively small (but varied) group of customers each year, so it is subject to variability from quarter to quarter.
Previous wording
We regularly assess trends relating to our recurring revenue, which is the revenue from consumables and service contracts, based on our product offerings, our customer base and our understanding of how our customers use our products. Recurring revenue was 61.7% and 48.3% of our total revenue for the three months ended September 30, 2025 and 2024, respectively. Recurring revenue was 59.3% and 56.8% for the nine months ended September 30, 2025 and 2024, respectively. Our recurring revenue as a percentage of the total product and service revenue will generally vary based upon the number of Growth Direct systems placed and the cumulative number of validated systems in the period, as well as other variables such as the volume of tests being conducted and the test application(s) being used on customers' Growth Direct systems.
Current wording
We regularly assess trends relating to our recurring revenue, which is the revenue from consumables and service contracts, based on our product offerings, our customer base and our understanding of how our customers use our products. Recurring revenue was 63.3% and 55.1% of our total revenue for the three months ended March 31, 2026 and 2025, respectively. Our recurring revenue as a percentage of the total product and service revenue will generally vary based upon the cumulative number of validated Growth Direct systems in the period, as well as other variables such as the volume of tests being conducted and the test application(s) being used on customers' Growth Direct systems.
Previous wording
We generate revenue from sales of our Growth Direct system (including our LIMS connection and Mold Alarm software), consumables, validation services, service contracts, and field service. We have historically primarily sold our products and services through direct sales representatives. Our sales arrangements are noncancellable and nonrefundable after ownership passes to the customer.
Current wording
We generate revenue from sales of our Growth Direct system (including our LIMS connection and other software), consumables, validation services, service contracts, and field service. We sell our products and services directly to customers and through distributors. Our sales arrangements are noncancellable and nonrefundable after ownership passes to the customer.
Previous wording
We derive product revenue primarily from the sale of our Growth Direct systems and related consumables as well as our LIMS connection software, which the majority of our customers purchase. As of September 30, 2025, we had placed 174 Growth Direct systems with approximately 50 customers globally, including approximately 75% of the top 20 pharmaceutical companies as measured by revenue, and the manufacturers of 16% of globally approved cell and gene therapies, including manufacturers of 86% of approved gene-modified autologous CAR-T cell therapies.
Current wording
We derive product revenue primarily from the sale of our Growth Direct systems and related consumables as well as our LIMS connection software, which the majority of our customers purchase. As of March 31, 2026, we had placed 196 Growth Direct systems with approximately 50 customers globally, including 75% of the top 20 largest pharmaceutical companies as measured by revenue, and the manufacturers of a number of globally approved cell and gene therapies, including manufacturers of 86% of approved gene-modified autologous CAR-T cell therapies.
Previous wording
We expect our Growth Direct system revenue to continue to grow over time as we increase system placements into our existing customers and markets and expand into new customers, markets and products. We recently announced the receipt of a large, multi-system customer order that we expect to contribute to our fourth quarter and full year 2025 results. If fulfilled in the contemplated timeframe, these system sales would be expected to contribute meaningfully to Growth Direct system revenue and placements in the fourth quarter. However, there can be no assurance that we will achieve placement of the ordered systems on the contemplated timing, if at all.
Current wording
We expect our Growth Direct system revenue to continue to grow over time as we increase system placements into our existing customers and markets and expand into new customers, markets and products. For instance, we announced the receipt of large, multi-system customer orders from Amgen and Samsung Biologics that contributed to our results for the quarters ended December 31, 2025 and March 31, 2026, respectively.
Previous wording
Our consumable revenue is a recurring product revenue stream comprised of proprietary consumables to capture test samples for analysis on the Growth Direct system. These proprietary consumables are an Environmental Monitoring consumable, a Water/Bioburden consumable and our Sterility consumable that we recently made available for commercial sale. These proprietary consumables support the growth-based compendial method for MQC testing mandated by global regulators and provide results that are comparable to traditional consumables. Our consumables are designed with features that enable automation on the Growth Direct system, with bar coding for tracking and data integrity, and physical characteristics for robotic handling, to support vision detection and prevent counterfeiting.
Current wording
Our consumable revenue is a recurring product revenue stream composed of three proprietary consumables to capture test samples for analysis on the Growth Direct system, an Environmental Monitoring ("EM") consumable, consumables for use in Water or Bioburden ("W/BB") applications, and a Sterility ("ST") consumable. Our proprietary consumables support the growth-based compendial method for MQC testing mandated by global regulators and provide results that are comparable to traditional consumables. Our consumables are designed with features that enable automation on the Growth Direct system, with bar coding for tracking and data integrity, and physical characteristics for robotic handling, to support vision detection, and to prevent counterfeiting.
Previous wording
We expect consumable revenue to increase in future periods as our base of cumulative validated Growth Direct systems grows and those systems enter routine use and utilize our consumables on a recurring, ongoing basis. In addition, greater utilization of our systems by our customers, as well as adoption by customers of new product offerings, including sterility-related consumables, is also expected to increase our consumables revenue.
Current wording
We expect consumable revenue to increase in future periods as our base of cumulative validated Growth Direct systems grows and those systems enter routine use and utilize our consumables on a recurring, ongoing basis.
Previous wording
We derive service revenue from validation services, field service including installations, and service contracts sold to our customers. Other than revenue from service contracts, which is recurring service revenue, revenue from all other field services as well as validation services are non-recurring service revenue streams.
Current wording
We derive service revenue from validation services, field service including installations, and service contracts sold to our customers. Revenue from validation services and field service are non-recurring service revenue streams, while revenue from service contracts is a recurring service revenue stream.
Previous wording
We offer our customers validation services (including related documentation) that enable them to replace their existing manual testing method and utilize their Growth Direct systems in compliance with relevant MQC regulations. We also offer validation services in connection with our LIMS connection software and Mold Alarm software. Validation services are recognized as revenue over time as these services are provided to the customer.
Current wording
We offer our customers validation services (including related documentation) that enable them to replace their existing manual testing method and utilize their Growth Direct systems in compliance with relevant MQC regulations. Validation services are recognized as revenue over time as these services are provided to the customer.
Previous wording
We also offer our customers field service which primarily consists of services provided by our field service engineers to install Growth Direct systems at customer sites, perform one-time paid field service, and provide preventative maintenance service during the one-year assurance warranty period. We recognize revenue from installation services, one-time paid field service, and preventative maintenance service during the assurance warranty period over time as these services are provided to the customer.
Current wording
We also offer our customers field service which primarily consists of services provided by our field service engineers to install Growth Direct systems at customer sites. We recognize revenue from field service over time as these services are provided to the customer.
Previous wording
Cost of product revenue primarily consists of costs for raw material parts and associated freight, shipping and handling costs, salaries and other personnel costs including stock-based compensation expense, contract manufacturer costs, scrap, warranty cost, inventory reserves, royalties, depreciation and amortization expense, allocated information technology and facility-related costs, overhead and other costs related to those sales recognized as product revenue in the period.
Current wording
Cost of product revenue primarily consists of costs for raw material parts and associated freight, shipping and handling costs, salaries and other personnel costs including non-cash stock-based compensation expense, contract manufacturer costs, scrap, warranty cost, inventory reserves, non-cash depreciation and amortization expense, allocated information technology and facility-related costs, overhead and other costs related to those sales recognized as product revenue in the period.
Previous wording
Cost of service revenue primarily consists of salaries and other personnel costs including stock-based compensation expense, travel costs, materials consumed when performing installations, validations and other services, allocated information technology and facility-related costs, costs associated with training, and other expenses related to service revenue recognized in the period.
Current wording
Cost of service revenue primarily consists of salaries and other personnel costs including non-cash stock-based compensation expense, travel costs, materials consumed when performing installations, validations and other services, allocated information technology and facility-related costs, costs associated with training, and other expenses related to service revenue recognized in the period.
Previous wording
For future periods, we expect our costs of revenue to increase or decrease commensurate with product and service volumes. Such costs may be further impacted by our ongoing efforts to reduce product costs and increase manufacturing productivity and efficiencies as well as service productivity. In addition, our product costs may be adversely impacted by recently enacted and potential future tariffs by the U.S. and other jurisdictions in which we conduct business. At this time, while we do not expect such impacts on our product costs to rise to levels that are material to our results of operations in the near-term, future changes in policies and other macroeconomic conditions could materially and adversely affect our operating expenses and results of operations.
Current wording
For future periods, we expect our costs of revenue to increase or decrease commensurate with product and service volumes. Such costs may be further impacted by our ongoing efforts to reduce product costs and increase manufacturing productivity and efficiencies as well as service productivity. In addition, our product costs may be adversely impacted by recently enacted and potential future tariffs by the U.S. and other jurisdictions in which we conduct business. Disruptions to international logistics and to the supply and cost of fuel resulting from recent conflicts in the Middle East also can contribute to increases in our costs. While we do not expect such impacts on our costs to rise to levels that are material to our results of operations in the near-term, future changes in policies and other macroeconomic conditions could materially and adversely affect our results of operations.
Previous wording
At the same time, we also expect future revenues from both products and services to grow at rates significantly higher than the related costs to provide and support those products and services. As a result, we also expect increasing revenues from both products and services to contribute significantly to future gross margin expansion. While we expect gross margins to continue to trend positively in the future, expansion in gross margins in future periods may not be linear and may be subject to variability from period to period.
Current wording
We expect that our gross margin percentage will increase over time as our future revenues from both products and services grow at rates significantly higher than the costs related to providing and supporting those products and services. However, expansion in gross margin percentage in future periods maynot be linear and may be subject to variability from period to period.
Previous wording
•Increasing productivity and efficiency in our service organization;
Current wording
We expect to achieve these increases through direct material cost reductions, increased manufacturing efficiencies for our products, including higher throughput on our automated consumables manufacturing line, leveraging our current cost structure to support future growth with minimal incremental investment, and by increasing productivity and efficiency in our service organization. We are also pursuing gross margin expansion opportunities through our MilliporeSigma partnership.
Previous wording
•employee-related expenses, including costs for salaries, bonuses and other personnel costs including stock-based compensation expense, for employees engaged in research and development functions;
Current wording
•employee-related expenses, including costs for salaries, bonuses and other personnel costs including non-cash stock-based compensation expense, for employees engaged in research and development functions;
Previous wording
•allocated information technology and facility-related costs, which include headcount-related costs for those functions as well as expenses for information technology systems and services, software, rent, facilities maintenance, and insurance as well as related depreciation and amortization.
Current wording
•allocated information technology and facility-related costs, which include headcount-related costs for those functions as well as expenses for information technology systems and services, software, rent, facilities maintenance, and insurance as well as related non-cash depreciation and amortization.
Previous wording
Sales and marketing expenses consist primarily of salaries, commissions, benefits and other personnel costs including stock-based compensation expense as well as costs relating to travel, consulting, public relations and allocated information technology and facility-related costs for our employees engaged in sales and marketing activities. For future periods, we expect sales and marketing expenses to increase or decrease as and when we make investments into our sales and marketing organization, including in the number of sales and marketing personnel and our continued efforts to expand our geographic reach and capabilities, broaden our customer base and introduce new products.
Current wording
Sales and marketing expenses consist primarily of salaries, commissions, benefits and other personnel costs including non-cash stock-based compensation expense as well as costs relating to travel, consulting, trade shows, customer events and demonstrations, information services, advertising and allocated information technology and facility-related costs for our employees engaged in sales and marketing activities. For future periods, we expect sales and marketing expenses to increase or decrease commensurate with the number of sales and marketing personnel, our geographic sales and marketing footprint, and the size of our customer base.
Previous wording
General and administrative expenses consist primarily of salaries, bonuses and other personnel costs including stock-based compensation expense for our executive, finance, legal, human resources and general management employees, as well as director and officer insurance costs and professional fees for legal, patent, accounting, audit, investor relations, recruiting, consulting, regulatory, compliance, board of directors' fees and other services. General and administrative expenses also include direct and allocated information technology and facility-related costs. For future periods, we expect these expenses to increase or decrease, as applicable, commensurate with the size, scope and complexity of our general and administrative functions.
Current wording
General and administrative expenses consist primarily of salaries, bonuses and other personnel costs including non-cash stock-based compensation expense for our executive, finance, legal, human resources and general management employees, as well as director and officer insurance costs and professional fees for legal, patent, accounting, audit, investor relations, recruiting, consulting, regulatory, compliance, board of directors' fees and other services. General and administrative expenses also include direct and allocated information technology and facility-related costs. For future periods, we expect these expenses to increase or decrease commensurate with the size, scope and complexity of our general and administrative functions.
Previous wording
We generated significant taxable losses during each of the three and nine months ended September 30, 2025 and 2024 and, therefore, have not recorded any U.S. federal or state income tax expense during those periods. However, we did record an immaterial amount of foreign income tax expense during each of those periods.
Current wording
We generated significant taxable losses during each of the three months ended March 31, 2026 and 2025, and therefore have not recorded any U.S. federal or state income tax expense during those periods. However, we did record an immaterial amount of foreign income tax expense during each of those periods.
Previous wording
Service revenue increased by $1.9 million, or 29.4%. The increase in service revenue was primarily driven by increases in revenue related to validations and installations (including higher one-time services unrelated to new system sales) as well as higher service contract revenue as a result of an increase in the cumulative number of Growth Direct systems validated and under such contracts.
Current wording
Service revenue decreased by $0.7 million, or 21.9%. The decrease in service revenue was primarily driven by a decrease in validation revenue, offset by higher service contract revenue as a result of an increase in the cumulative number of systems validated and under such contracts. Service revenue from validations, which is recognized when those services are provided, generally lag the related system placements by three to nine months.
Previous wording
Cost of service revenue decreased by $0.1 million, or 5.3%. The decrease was primarily attributable to lower service headcount and related costs due in part to productivity improvements.
Current wording
Cost of service revenue decreased by $0.2 million, or 9.4%. The decrease was primarily attributable to lower service headcount and related costs.
Previous wording
Research and development expenses decreased by $0.8 million, or 7.3%. The decrease was primarily driven by lower headcount and headcount-related costs as well as the timing of spending related to new product development activities.
Current wording
Research and development expenses decreased by $0.3 million, or 7.3%. The decrease was primarily driven by lower headcount and headcount-related costs as well as the timing of spending related to new product development activities.
Previous wording
Sales and marketing expenses decreased by $0.5 million, or 14.2%. This decrease was primarily driven by lower headcount-related and third-party consulting costs.
Current wording
Sales and marketing expenses increased by $0.7 million, or 24.4%. This increase was primarily driven by higher headcount-related costs and third-party consulting costs.
Previous wording
General and administrative expenses increased by $0.3 million, or 1.7%. This increase was primarily attributable to higher non-cash stock compensation expense and legal fees, partially offset by a reduction in consulting fees and business insurance premiums.
Current wording
General and administrative expenses increased by $1.8 million, or 30.8%. This increase was primarily attributable to higher headcount related costs, including non-cash stock compensation expense and severance, partially offset by a reduction in consulting fees.
Previous wording
Interest income, decreased $1.4 million, or 54.6% due to lower interest rates earned on our cash equivalents and investments balances.
Current wording
Interest income for the three months ended March 31, 2026 and 2025 was $0.3 million and $0.5 million, respectively. The decrease of $0.2 million, or 45.1%, was due to lower interest rates earned on our cash equivalents and investments balances, as well as lower cash equivalents and investment balances during the year.
Previous wording
Interest expense increased $0.4 million, or 1389.3%, due to interest incurred with our long term debt.
Current wording
Interest expense for the three months ended March 31, 2026 and 2025 was $0.6 million and less than $0.1 million, respectively. The increase of $0.6 million, or 5,225.0%, was due to interest incurred with our long-term debt.
Previous wording
Other expense, net, which is comprised of miscellaneous expenses unrelated to our core business, was flat for each of the three months ended September 30, 2025 and 2024.
Current wording
Other expense, net, which is comprised of miscellaneous expenses unrelated to our core business, was less than $0.1 million for each of the three months ended March 31, 2026 and 2025, respectively.
Previous wording
Income tax expense was less than $0.1 million for each of the three months ended September 30, 2025 and 2024. The expense in each period was attributable to income tax provisions related to our foreign subsidiaries.
Current wording
Income tax expense was less than $0.1 million for each of the three months ended March 31, 2026 and 2025. The expense recorded related to our German and Swiss subsidiaries.
Previous wording
Since our inception, we have incurred operating losses. To date, we have funded our operations primarily through proceeds from sales of redeemable convertible preferred stock, borrowings under loan agreements, revenue from sales of our products and services, and the proceeds from our IPO. In addition, in August 2025, we entered into the LSA with Trinity Capital, providing for up to $45.0 million of senior secured term loans available to us in multiple tranches, including an initial $20.0 million advance funded in August 2025. The LSA is described in more detail in Note 9 to our unaudited condensed consolidated financial statements contained in Part I, Item I of this Quarterly Report on Form 10-Q.
Current wording
Since our inception, we have incurred operating losses. To date, we have funded our operations primarily through proceeds from sales of redeemable convertible preferred stock, borrowings under loan agreements, revenue from sales of our products and services, proceeds from our IPO, and proceeds from our "at-the-market" ("ATM") facility.
Previous wording
We believe that our cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months following the date the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 were issued.
Current wording
We believe that our cash, cash equivalents and investments and additional borrowing capacity expected to become available under the LSA that is subject to the satisfaction of certain commercial and operational milestones and other conditions later this year will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months following the date the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 were issued. However, if our expectations and underlying assumptions of business performance, including revenue growth, gross margin improvements, and/or control of operating costs are not realized, we may need to raise additional funding, which could be through equity offerings, debt financings or a combination thereof. If we are unable to raise capital as, if and when, needed, we may have to significantly delay, scale back or discontinue our expansion plans including further development and commercialization efforts of one or more of our products.
Previous wording
In October 2013, we entered into an operating lease for office and manufacturing space in Lowell, Massachusetts. In March 2022, we amended the lease to increase the amount of facility space subject to the lease and extend the expiration of the lease from July 2026 to July 2029. The terms of the amendment include options for a one-time, five-year extension of the lease and early termination of the lease in July 2026 (subject to an early termination fee). Monthly rent payments are fixed and future minimum lease payments under the lease (as amended) are $2.7 million as of September 30, 2025, including $0.6 million in short-term obligations.
Current wording
In October 2013, we entered into an operating lease for office and manufacturing space in Lowell, Massachusetts. In March 2022, we amended the lease to increase the amount of facility space subject to the lease and extend the expiration of the lease from July 2026 to July 2029. The terms of the amendment include options for a one-time, five-year extension of the lease and early termination of the lease in July 2026 (subject to an early termination fee). Monthly rent payments are fixed and future minimum lease payments under the lease (as amended) are $2.2 million as of March 31, 2026, including $0.7 million in short-term obligations.
Previous wording
In June 2021, we entered into a sublease agreement for our Lexington, Massachusetts headquarters, which expires in June 2029. The sublease includes an option to terminate the sublease in July 2026, subject to an early termination fee. Monthly rent payments are fixed and future minimum lease payments over the term of the sublease are $3.0 million as of September 30, 2025, including $0.7 million in short-term obligations. Concurrent with entering into the sublease agreement, we executed an option agreement with the property owner which provides us the option to enter into a new direct lease for our Lexington, Massachusetts facility for an additional five years following expiration of the sublease.
Current wording
In June 2021, we entered into a sublease agreement for our Lexington, Massachusetts headquarters, which expires in June 2029 (the "sublease agreement"). The sublease agreement includes an option to terminate the sublease in July 2026, subject to an early termination fee. Monthly rent payments are fixed and future minimum lease payments over the term of the sublease are $2.5 million as of March 31, 2026, including $0.8 million in short-term obligations. Concurrent with entering into the sublease agreement, we executed an option agreement with the property owner which provides us the option to enter into a new direct lease for our Lexington, Massachusetts facility for an additional five years following expiration of the sublease.
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Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In February 2025, we entered into a Distribution and Collaboration Agreement (the “Distribution Agreement”) with Millipore S.A.S., a subsidiary of the Life Science business of Merck KGaA, Darmstadt, Germany, which operates in the
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
Significant Accounting Policies — to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.