10q10k10q10k.net

What changed in 908 Devices Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of 908 Devices Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+505 added−592 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-07)

Top changes in 908 Devices Inc.'s 2025 10-K

505 paragraphs added · 592 removed · 353 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

97 edited+11 added−101 removed51 unchanged
Biggest changeWe also conduct additional research and development operations out of our facility in Morrisville to support assay development for Rebel, Maverick and ZipChip, and out of our facility in Braunschweig, Germany to support assay development of our Maven and related products and aseptic sampling development. 21 Table of Contents Competition We have a range of competitors extending from small, privately held companies with single-point solutions to large, publicly-held corporations, including those with a portfolio of Mass Spec products, such as Agilent, Bruker, Danaher, Inficon, Teledyne, Endress & Hauser, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.
Biggest changeOur research and development operations are conducted in our Burlington, Massachusetts facility and our Danbury, Connecticut facility. Competition We have a range of competitors extending from small, privately held companies with single-point solutions to large, publicly-held corporations, including those with a portfolio of Mass Spec and/or spectroscopy products, such as Agilent, Bruker, Danaher, Inficon, Teledyne, Rigaku, and Thermo Fisher Scientific.
Licensed IP University of North Carolina, Chapel Hill In June 2012, we entered into a license agreement, which was subsequently amended in April 2013 and August 2014, and then amended and restated in May 2015, which we refer to in this Annual Report on Form 10-K as the UNC Agreements, with the University of North Carolina, Chapel Hill, or UNC, pursuant to which UNC granted us an exclusive, sublicensable, worldwide license to develop, manufacture, use, and commercialize products, services and methods, covered by certain patent rights owned by UNC, including patents related to a microfabricated ionization source and a microfabricated ionizer chip.
Licensed IP University of North Carolina, Chapel Hill In June 2012, we entered into a license agreement, which was subsequently amended in April 2013 and August 2014, and then amended and restated in May 2015, which we refer to in this Annual Report on Form 10-K as the UNC Agreement, with the University of North Carolina, Chapel Hill, or UNC, pursuant to which UNC granted us an exclusive, sublicensable, worldwide license to develop, manufacture, use, and commercialize products, services and methods, covered by certain patent rights owned by UNC, including patents related to a microfabricated ionization source and a microfabricated ionizer chip.
Several examples of these elements are highlighted below in the “Our Products” section. Our Products We were founded on a vision to deliver high quality chemical analysis to a broad set of users at the point-of-need. We offer handheld and desktop devices, each of which are capable of providing quick, high-fidelity and actionable results.
Several examples of these elements are highlighted below in the “Our Products” section. Our Products We were founded on a vision to deliver high quality chemical analysis to a broad set of users at the point-of-need. We offer handheld devices, each of which are capable of providing quick, high-fidelity and actionable results.
This ability to automatically control the system reduces or eliminates the user’s responsibility and opportunity for error in set up, optimization, and troubleshooting. Our product’s screen shown above right looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.
This ability to automatically control the system reduces or eliminates the user’s responsibility and opportunity for error in set up, optimization, and troubleshooting. Our product’s screen shown above looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.
We plan to continue to expand into these regions via initial penetration with channel partners and then subsequent support with direct sales and support personnel. Our business model is focused on driving the adoption of our products and maximizing use across our customers’ value chains.
We plan to continue to expand into these regions via initial penetration with channel partners and then subsequent support with direct sales, application and support personnel. Our business model is focused on driving the adoption of our products and maximizing use across our customers’ value chains.
Users do not need to take a risk on a completely unknown technology. We bring laboratory-grade capability to handhelds and desktops. We have developed a proprietary Mass Spec platform and approach that allow us to move the capabilities of conventional Mass Spec beyond the central laboratory.
Users do not need to take a risk on a completely unknown technology. We bring laboratory-grade capability to handhelds. We have developed a proprietary Mass Spec platform and approach that allow us to move the capabilities of conventional Mass Spec beyond the central laboratory.
Leveraging our technology platform, we have developed a portfolio of desktop and handheld devices that are reinventing how and where lab-grade chemical analysis is conducted by accessing a variety of point-of-need market segments that were historically considered impossible.
Leveraging our technology platform, we have developed a portfolio of handheld devices that are reinventing how and where lab-grade chemical analysis is conducted by accessing a variety of point-of-need market segments that were historically considered impossible.
Our Technology Our Technology Platform We have developed a core technology platform designed to bring Mass Spec and optical spectroscopy out of the confines of central laboratories and to the point-of-need with high-fidelity handheld and desktop devices.
Our Technology Our Technology Platform We have developed a core technology platform designed to bring Mass Spec and optical spectroscopy out of the confines of central laboratories and to the point-of-need with high-fidelity handheld devices.
This HPMS approach results in devices with dramatically smaller size and lower cost-of-goods through a reduction of vacuum pump requirements and power consumption, and an overall simplification of the hardware topology. ​ ​ Conventional laboratory Mass Spec Our Mass Spec 9 Table of Contents ​ HPMS allows us to build ultracompact, high-fidelity measurement devices that are purpose-built for specific applications and deployable at the point-of-need.
This HPMS approach results in devices with dramatically smaller size and lower cost-of-goods through a reduction of vacuum pump requirements and power consumption, and an overall simplification of the hardware topology. ​ ​ ​ Conventional laboratory Mass Spec Our Mass Spec ​ 7 Table of Contents HPMS allows us to build ultracompact, high-fidelity measurement devices that are purpose-built for specific applications and deployable at the point-of-need.
The rugged diamond attenuated total reflection (“ATR”) sample interfaces provide reliable measurement in harsh environments. The device’s interactive, on-screen prompts guide emergency and military responders through the sampling process.
The rugged diamond attenuated total reflection (“ATR”) sample interfaces provide reliable measurement in harsh environments. The device’s interactive, on-screen prompts guide emergency and military responders through the sampling.
Leveraging mass spectrometry, or Mass Spec, and optical spectroscopy, microfluidics, and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.
Leveraging mass spectrometry, or Mass Spec, and optical spectroscopy, analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.
We will focus on building upon our track record of leveraging our customers’ success in trials and pilots into enterprise-wide adoption of both devices and consumables. As an example, for our handheld device, it is typical for government organizations to conduct a one week or longer trial prior to purchase to test our technology in their real-world setting.
We will focus on building upon our track record of leveraging our customers’ success in trials and pilots into enterprise-wide adoption of both devices and consumables. As an example, it is typical for government organizations to conduct a one week or longer trial prior to purchase to test our technology in their real-world setting.
However, while Mass Spec is an extremely powerful analytical technique, the capabilities of conventional Mass Spec instruments are largely relegated to centralized laboratory settings due to their size, complexity, and high price. Given the inherent limitations of conventional mainframe Mass Spec instruments, we believe there is a compelling opportunity for handheld and compact desktop Mass Spec devices.
However, while Mass Spec is an extremely powerful analytical technique, the capabilities of conventional Mass Spec instruments are largely relegated to centralized laboratory settings due to their size, complexity, and high price. Given the inherent limitations of conventional mainframe Mass Spec instruments, we believe there is a compelling opportunity for handheld Mass Spec devices.
Analytics and Machine Learning Technology Provide Actionable Answers, Not Just Raw Data The third crucial element of our technology platform is holistic device design with embedded analytics and machine learning. Our development team designs devices for a specific purpose, rather than for a wide scope of often disparate needs.
Analytics and Machine Learning Technology Provide Actionable Answers, Not Just Raw Data The second crucial element of our technology platform is holistic device design with embedded analytics and machine learning. Our development team designs devices for a specific purpose, rather than for a wide scope of often disparate needs.
Our Growth Strategy We are making chemical analysis simple, smart and speedy by incorporating our microscale Mass Spec, optical spectroscopy, microfluidics, and analytics and machine learning technology platform into handheld and desktop devices that provide users with robust answers at the point of need.
Our Growth Strategy We are making chemical analysis simple, smart and speedy by incorporating our microscale Mass Spec, optical spectroscopy, and analytics and machine learning technology platform into handheld devices that provide users with robust answers at the point of need.
As of December 31, 2024, a substantial majority of our employees were located in the United States. None of our employees is represented by a labor union or is subject to a collective bargaining agreement. We consider our relationship with our employees to be good.
As of December 31, 2025, a substantial majority of our employees were located in the United States. None of our employees is represented by a labor union or is subject to a collective bargaining agreement. We consider our relationship with our employees to be good.
We are responsible for all reasonable, documented patent expenses incurred during the life of the UNC Agreements and associated costs associated with the preparation, filing, prosecuting, issuance and maintenance of all patent applications and patents included within the patent rights covered by the UNC Agreements.
We are responsible for all reasonable, documented patent expenses incurred during the life of the UNC Agreement and associated costs associated with the preparation, filing, prosecuting, issuance and maintenance of all patent applications and patents included within the patent rights covered by the UNC Agreement.
Item 1. Business. Analysis at the Speed of Life We are making revolutionizing chemical and biochemical analysis simple, smart and speedy with our purpose-built handheld and desktop devices that empower people to take swift action in life-altering applications. Company Overview We have developed an innovative suite of purpose-built handheld and desktop devices for point-of-need chemical analysis.
Item 1. Business. Analysis at the Speed of Life We are making chemical analysis simple, smart and speedy with our purpose-built handheld devices that empower people to take swift action in life-altering applications. Company Overview We have developed an innovative suite of purpose-built handheld devices for point-of-need chemical analysis.
Under generally applicable U.S. trade regulations administered by the Office of Foreign Assets Control, or OFAC, of the U.S. Department of the Treasury, we are generally prohibited from engaging in transactions involving sanctioned countries, as well as certain persons and entities that have been designated for targeted sanctions by OFAC.
Under generally applicable U.S. trade regulations administered by the Office of Foreign Assets Control, or OFAC, of the U.S. Department of the Treasury, we are generally prohibited from engaging in direct or indirect transactions or dealings involving sanctioned countries, as well as certain persons and entities that have been designated for targeted sanctions by OFAC.
EAR and ITAR also impose export restrictions targeted at identified persons and entities, and we are required to comply with these restrictions as well. Violations of the ITAR, EAR, and OFAC requirements can result in significant fines, penalties, denial of export privileges, and even terms of imprisonment for the individuals involved. In addition, the U.S.
EAR and ITAR also impose export restrictions targeted at identified persons and entities, and we are required to comply with these restrictions as well. Violations of the ITAR, EAR, and OFAC requirements can result in significant fines, penalties, denial of export privileges, and even terms of imprisonment for the individuals involved.
The UNC Agreement will continue until the expiration of the last to expire patent or last to be abandoned patent application that is licensed to us, unless terminated earlier in accordance with the terms of the UNC Agreements. There are current patent applications pending under the UNC Agreements so we expect the UNC Agreements will continue through at least 2039.
The UNC Agreement will continue until the expiration of the last to expire patent or last to be abandoned patent application that is licensed to us, unless terminated earlier in accordance with the terms of the UNC Agreement. There are current patent applications pending under the UNC Agreement so we expect the UNC Agreement will continue through at least 2037.
The combination of HPMS, our proprietary microfluidic sampling and separation technology, and our data analytics, and machine-learning technology provides the foundations of an adaptable platform that can serve a growing number of new and adjacent applications and markets. ● Point-of-need technologies disrupting conventional lab-based chemical analysis .
The combination of HPMS, our proprietary data analytics, and machine-learning technology provides the foundations of an adaptable platform that can serve a growing number of new and adjacent applications and markets. ● Point-of-need technologies disrupting conventional lab-based chemical analysis .
We believe that providing simple, smart, and speedy devices that provide robust answers when and where people need them gives rise to: ● an expanded and more diverse set of users; ● more frequent measurements; and 8 Table of Contents ● new use cases that were previously untenable.
We believe that providing simple, smart, and speedy devices that provide robust answers when and where people need them gives rise to: ● an expanded and more diverse set of users; ● more frequent measurements; and ● new use cases that were previously untenable.
We intend to expand our sales, support, and marketing efforts in regions where we believe that there is significant opportunity, including Europe, the Middle East, Asia-Pacific countries such as India and South Korea as well as other areas such as Australia and South America.
We intend to expand our sales, support, and marketing efforts in regions where we believe that there is significant opportunity, including Europe, the Middle East, and Asia-Pacific as well as other areas such as Australia and South America.
Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce 6 Table of Contents significantly smaller, purpose-built Mass Spec devices that are better suited for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.
Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce significantly smaller, purpose-built Mass Spec devices that are better suited for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.
A trial generally results in budgeting for 7 Table of Contents a pilot that can range in size from ten to more than 50 units. During the pilot, we support our customers closely to ensure their success. Data is compiled throughout to assist our customer in making a larger enterprise-wide justification, purchase and deployment.
A trial generally results in budgeting for a pilot that can range in size from ten to more than 50 units. During the pilot, we support our customers closely to ensure their success. Data is compiled throughout to assist our customer in making a larger enterprise-wide justification, purchase and deployment.
Conventional Mass Spec manufacturers focus their attention on canonical analytical specifications such as “instrument resolution” or “detection limit” or “data rate” in the hopes of appealing to a wide range of laboratory specialist needs. Our devices are designed to do a job quickly, easily, and cost effectively.
Conventional lab instrumentation manufacturers focus their attention on canonical analytical specifications such as “instrument resolution” or “detection limit” or “data rate” in the hopes of appealing to a wide range of laboratory specialist needs. Our devices are designed to do a job quickly, easily, and cost effectively.
As our primary point of contact in the marketplace, our sales force focuses on delivering a consistent marketing message and high level of customer service, while also attempting to help us better understand the evolving market and customer needs. As of December 31, 2024, we had 59 people employed in sales, sales support and marketing.
As our primary point of contact in the marketplace, our sales force focuses on delivering a consistent marketing message and high level of customer service, while also attempting to help us better understand the evolving market and customer needs. As of December 31, 2025, we had 35 people employed in sales, sales support and marketing.
UNC may terminate the UNC Agreements if we violate or fail to perform any terms of the UNC Agreements and we fail to cure such violation or failure within 90 days of notice thereof from UNC. 23 Table of Contents Regulations Chemical detection, identification, and authentication technologies are of value to military, governmental, and law enforcement organizations worldwide.
UNC may terminate the UNC Agreement if we violate or fail to perform any terms of the UNC Agreements and we fail to cure such violation or failure within 90 days of notice thereof from UNC. 16 Table of Contents Regulations Chemical detection and identification technologies are of value to military, governmental, and law enforcement organizations worldwide.
More than 12,000 operators, including in numerous domestic and foreign government agencies, have been trained to use the MX908.
More than 14,000 operators, including in numerous domestic and foreign government agencies, have been trained to use the MX908.
We refer to this support as our Reachback program. 20 Table of Contents ● Software updates and library updates. We periodically release updates to the embedded software in our products. These updates will ensure the ongoing functionality of our products and repair defects in the software.
We refer to this support as our Reachback program. ● Software updates and library updates. We periodically release updates to the embedded software in our products. These updates will ensure the ongoing functionality of our products and repair defects in the software.
As of December 31, 2024, we had 71 full-time employees dedicated to research and development. Of these, approximately 49% have advanced degrees in engineering or the sciences. We have made substantial investments in product and technology development since our inception.
As of December 31, 2025, we had 43 full-time employees dedicated to research and development. Of these, approximately 49% have advanced degrees in engineering or the sciences. We have made substantial investments in product and technology development since our inception.
Once samples have been collected, and a Wi-Fi connection is established, the results can be uploaded to our Team Leader mobile app for remote personnel to assist in making rapid, informed decisions based on a clear understanding of the chemical hazards. ProtectIR The ProtectIR is a handheld FTIR device that can identify 23,000+ solid and liquid chemical hazards.
Like all our FTIR products, once samples have been collected, and a Wi-Fi connection is established, the results can be uploaded to our Team Leader mobile app for remote personnel to assist in making rapid, informed decisions based on a clear understanding of the chemical hazards. 11 Table of Contents ProtectIR The ProtectIR is a handheld FTIR device that can identify 23,000+ solid and liquid chemical hazards.
Our technical support, also known as our Reachback program, allows any participating MX908 and FTIR device user to email, text, or call a 908 Devices Scientific Support Team member to receive support 24 hours per day, 365 days per year to ensure their device is working as intended.
Our technical support, also known as our Reachback program, allows any participating device users to email, text, or call a 908 Devices Scientific Support Team member to receive support 24 hours per day, 365 days per year to ensure their device is working as intended.
The InterceptIR device is integrated onto a variety of robotic platforms, including robotic canines, wheeled vehicles and unmanned autonomous vehicles and drones. The device rapidly detects and identifies 5,600+ gas and vapor chemical hazards. It is used primarily to screen large areas and inaccessible spaces.
A headless variant of XplorIR, called InterceptIR, can be integrated onto a variety of robotic platforms, including robotic canines, wheeled vehicles and unmanned autonomous vehicles and drones. The device rapidly detects and identifies 5,600+ gas and vapor chemical hazards. It is used primarily to screen large areas and inaccessible spaces.
We use our annual demand planning to assess initial device needs for each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.
We plan to continue the diversification of our supply chain as we scale. We use our annual demand planning to assess initial device needs for each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.
Analytical Technology Platform for Chemical Analysis at the Point-of-Need Mass Spec is the gold-standard analytical technique for molecular analysis. This technology is highly regarded for its ability to provide an extraordinarily detailed analysis of a wide variety of molecular samples -- from small molecule chemicals to large complex proteins.
Mass Spectrometry Mass Spec is the gold-standard analytical technique for molecular analysis. This technology is highly regarded for its ability to provide an extraordinarily detailed analysis of a wide variety of molecular samples -- from small molecule chemicals to large complex proteins.
In North America, we use channel partners to provide our products to end customers where a contract vehicle is required. Since the commercial launch of our first handheld, the installed base of our devices has grown to more than 3,500 devices across more than 63 countries.
In North America, we use channel partners to provide our products to end customers where a contract vehicle is required. Since the commercial launch of our first handheld, the installed base of our devices has grown to more than 3,700 devices worldwide.
The term “products” or “devices” used in this “Business” section each refer to the MX908, ThreatID, ProtectIR, XplorIR, Rebel, ZipChip Interface, Maverick, and Maven and related sampling devices. We create simplified measurement devices that our customers can use as accurate tools where-and-when their work needs to be done, rather than overly complex and centralized analytical instrumentation.
The term “products” or “devices” used in this “Business” section each refer to the MX908, ThreatID, ProtectIR, XplorIR, and VipIR. We create simplified measurement devices that our customers can use as accurate tools where-and-when their work needs to be done, rather than overly complex and centralized analytical instrumentation.
We may terminate the UNC Agreements by providing advance written notice of 60 days as specified therein.
We may terminate the UNC Agreement by providing advance written notice of sixty (60) days as specified therein.
It is our belief that investment pre- and post-sale with prospects that have the potential for enterprise adoption creates a predictable pipeline of opportunity for our devices and their entrenchment as they become the organizational standard for our customers.
It is our belief that investment pre- and post-sale with prospects that have the potential for enterprise adoption creates a predictable pipeline of opportunity for our devices and their entrenchment as they become the organizational standard for our customers. ● Grow the installed base through expansion of commercial channels .
This staff is primarily located in the United States, but we have also hired internationally at our facility in Braunschweig, Germany, and in other countries using a professional employment organization, to support our sales and applications efforts.
This staff is primarily located in the United States, but we have also hired internationally using a professional employment organization, to support our sales and applications efforts.
Additionally, we must pay UNC a low single digit percentage royalty on our net sales of any products that are covered by a valid claim of the licensed patents, subject to an annual minimum royalty payment of $30,000. We are also obligated to pay UNC a low double-digit percentage of certain royalty income received from our sublicensees.
Additionally, we must pay UNC a low single digit percentage royalty on our net sales of any products that are covered by a valid claim of the licensed patents, subject to an annual minimum royalty payment of $30,000.
It is an agile, multi-purpose device utilized by a wide spectrum of user segments for a variety of forensic field applications such as chemical, explosive, priority drug and HazMat operations, detecting materials at the trace level. 13 Table of Contents We have sold more than 2,800 MX908s into every U.S. state, in 63 countries and across five continents.
It is an agile, multi-purpose device utilized by a wide spectrum of user segments for a variety of field applications such as chemical, explosive, priority drug and HazMat operations, detecting materials at the trace level. We have sold more than 3,100 MX908s into every U.S. state and across five continents.
Customers can call a hot-line number 24 hours per day, 365 days per year for support on issues ranging from questions on proper usage of the device, to assistance in interpretation of chemical spectra to ensure the device is working as intended.
Support under warranty and extended service contracts include the following: ● Technical support. Customers can call a hot-line number 24 hours per day, 365 days per year for support on issues ranging from questions on proper usage of the device, to assistance in interpretation of chemical spectra to ensure the device is working as intended.
They can manage themselves by adapting to environmental factors like elevation, humidity, temperature, and vibration, and by optimizing themselves for the analytical objectives of the user, such as looking for traces of potent drug substances or sniffing for airborne hazards.
Control/optimization: Our devices need to manage themselves autonomously for maximum value to the customer. They can manage themselves by adapting to environmental factors like elevation, humidity, temperature, and vibration, and by optimizing themselves for the analytical objectives of the user, such as looking for traces of potent drug substances or sniffing for airborne hazards.
The team possesses deep expertise in Mass Spec, system design and engineering, usability and ergonomics, thermal and mechanical engineering, software development, artificial intelligence, and optical spectroscopy, as well as microfluidics and separations science. We had 71 full-time employees dedicated to research and development as of December 31, 2024. Of these, approximately 49% have advanced degrees in science and engineering.
The team possesses deep expertise in Mass Spec, spectroscopy, system design and 5 Table of Contents engineering, usability and ergonomics, thermal and mechanical engineering, software development, and artificial intelligence. We had 43 full-time employees dedicated to research and development as of December 31, 2025. Of these, approximately 49% have advanced degrees in science and engineering.
We also release updates and additions to our library of spectral images enabling identification of additional chemicals. ● Warranty. Our Maven, Maverick, MX908 and ZipChip Interface devices are covered under a return-to-factory warranty model for repairs. Depending on availability, loaner units are made available to minimize downtime with our customers.
We also release updates and additions to our library of spectral images enabling identification of additional chemicals. ● Warranty. Our devices are covered under a return-to-factory warranty model for repairs. Depending on availability, loaner units are made available to minimize downtime with our customers. We provide training at the customer’s location with the initial purchase of our devices.
Customers We sell our products worldwide through an experienced direct sales force as well as through domestic and international channel partners. Our customers are primarily in the pharmaceutical and biotech market, the government market and to a lesser extent, the academic market.
Our customers value the low-logistics tail of our MX908. Customers We sell our products worldwide through an experienced direct sales force as well as through domestic and international channel partners. Our customers are primarily in the government market and to a lesser extent, the life sciences market.
Our patent strategy is to seek broad protection on fundamental enabling technologies, and layer on additional patents on specific implementations or methods of operation critical to our present and anticipated products, and to prevent competitive operation.
Our patent strategy is to seek broad protection on fundamental enabling technologies, and layer on additional patents on specific implementations or methods of operation critical to our present and anticipated products, and to prevent competitive operation. We provide our products to customers pursuant to terms and conditions that impose restrictions on use and disclosure.
Accordingly, our research and development team possesses functional expertise in critical areas such as: ● chemistry, biochemistry, physics of Mass Spec and separations and sample processing; ● embedded, desktop and mobile software engineering; ● machine learning, high-speed digital signal processing, multivariate statistical learning, algorithms and decision theory; ● user experience design and user interface design; ● mechanical engineering and industrial design; ● analog, digital and mixed signal electronics engineering; ● ultra-efficient pumping and pneumatics engineering; and ● microfluidic design, and volume fabrication at the micro- and meso-scale.
Accordingly, our research and development team possesses functional expertise in critical areas such as: ● Analytical chemistry, physics of Mass Spectrometry and spectroscopy, and optical design; ● embedded, desktop and mobile software engineering; ● machine learning, high-speed digital signal processing, multivariate statistical learning, algorithms and decision theory; ● user experience design and user interface design; ● mechanical engineering and industrial design; 14 Table of Contents ● analog, digital and mixed signal electronics engineering; and ● ultra-efficient pumping and pneumatics engineering.
We provide training at the customer’s location with the initial purchase of our devices. Each training event is between four to six hours and covers device functionality and hands-on training with the device. At the conclusion of the training, certificates are issued for all attendees. Additional training days are available on a per diem basis.
Each training event is between four to six hours and covers device functionality and hands-on training with the device. At the conclusion of the training, certificates are issued for all attendees. Additional training days are available on a per diem basis. Research and Development Investment in research and development is at the core of our business strategy.
The subject matter covered by our owned patent assets includes core aspects of compact Mass Spec technology, a design for a handheld Mass Spec device, a design for a modular Mass Spec chamber, patents for multiple ionization modes and adaptive pressure operation within survey period, the determination of preferred ionization mode, adaptive resolution control, adaptive operation to reduce power consumption, and the detection of positive and negative ions. 22 Table of Contents As of December 31, 2024, our in-licensed patent assets included approximately 30 U.S. patents, no pending U.S. patent applications, 22 foreign patents, and two pending foreign patent applications.
The subject matter covered by our owned patent assets includes core aspects of compact Mass Spec technology, a design for a handheld Mass Spec device, a design for a 15 Table of Contents modular Mass Spec chamber, patents for multiple ionization modes and adaptive pressure operation within survey period, the determination of preferred ionization mode, adaptive resolution control, adaptive operation to reduce power consumption, the detection of positive and negative ions, and various sampling devices and methods.
Human Capital As of December 31, 2024, we had 246 full-time employees, of which 59 work in sales, sales support and marketing, 71 work in engineering and research and development, 78 work in manufacturing, operations and service and 38 work in general and administrative.
Human Capital As of December 31, 2025, we had 172 full-time employees, of which 35 work in sales, sales support and marketing, 43 work in engineering and research and development, 62 work in manufacturing, operations and service and 32 work in general and administrative.
As we continue to expand the capabilities of our technology platform, we believe our devices will continue to penetrate new and adjacent applications and markets. ● Highly attractive business model validated by rapidly growing installed base of devices.
As we continue to expand the capabilities of our technology platform, we believe our devices will continue to penetrate new and adjacent applications and markets. ● Highly attractive business model validated by rapidly growing installed base of devices. We have over 700 customers, including major government institutions, the Department of Homeland Security, the U.S. Army and the U.S.
The device is compact, lightweight and rugged as it is specifically designed for field use. ProtectIR enables hazmat response teams, military, and first responders to analyze bulk substances in seconds and requires with minimal user inputs. Desktop Devices Rebel The Rebel is a small desktop analyzer providing real-time information on the extracellular environment in bioprocesses.
The device is compact, lightweight and rugged as it is specifically designed for field use. ProtectIR enables hazmat response teams, military, and first responders to analyze bulk substances in seconds and requires minimal user inputs.
In addition, we generally control access to our proprietary and confidential information through the use of internal and external controls. Our foundational technology in the area of miniature Mass Spec originated as an effort at Oak Ridge National Laboratories led by our Scientific Founder J. Michael Ramsey, Professor Emeritus of Chemistry at the University of North Carolina.
Our foundational technology in the area of miniature Mass Spec originated as an effort at Oak Ridge National Laboratories led by our Scientific Founder J. Michael Ramsey, Professor Emeritus of Chemistry at the University of North Carolina.
The core elements of our technology platform include: ● Complementary analytical technologies, including Mass Spec and optical spectroscopy, purpose built for point-of-need applications; ● Microfluidics, which enable convenient sample preparations, fast separations, and aseptic sampling; and ● Analytics and machine learning technology, which provides actionable answers versus raw data.
The core elements of our technology platform include: ● Complementary analytical technologies, including Mass Spec and optical spectroscopy, purpose built for point-of-need applications; and ● Analytics and machine learning technology, which provides actionable answers versus raw data. Analytical Technology Platform for Chemical Analysis at the Point-of-Need Our analytical technology hardware platform consists of both mass spectrometry and optical spectroscopy.
Given the market opportunity, we expect to face substantial competition from large established manufacturers of laboratory-based instruments and from new entrants; however, our proprietary advances have enabled us to manufacture the first truly handheld Mass Spec devices and compact desktops and we believe we are well-positioned to face future competition.
Given the market opportunity, we expect to face substantial competition from large established manufacturers of laboratory-based instruments and from new entrants. However, our proprietary innovations have enabled us to deliver the first truly handheld mass spectrometry devices, and together with our complementary optical spectroscopy platform, we believe we are strongly positioned to compete effectively.
The health and safety of our employees, customers and communities are of primary concern. Corporate Information We were incorporated in Delaware in 2012 as 908 Devices Inc. Our offices are located at 645 Summer Street, Boston, Massachusetts 02210. Our telephone number is (857) 254-1500.
The health and safety of our employees, customers and communities are of primary concern. Corporate Information We were incorporated in Delaware in 2012 as 908 Devices Inc. Our offices are located at 44 3rd Avenue, Burlington, Massachusetts 01803. Our telephone number is (857) 254-1500. 17 Table of Contents Available Information Our Internet address is www.908devices.com.
While we believe that alternatives are available, it would take time to identify and validate replacement swab samples, which could compromise our ability to supply these to our MX908 customers on a timely basis. 19 Table of Contents In 2024, we completed the transfer of our consumable kit and microfluidic chip manufacturing from our Boston cleanroom facilities to our Morrisville cleanroom facilities.
While we believe that alternatives are available, it would take time to identify and validate replacement swab samples, which could compromise our ability to supply these to our MX908 customers on a timely basis.
Our Strengths We believe the following competitive strengths provide us the ability to address point-of-need applications in forensics, life sciences research, bioprocessing, quality assurance/quality control, and synthetic biology: ● Our proprietary microscale Mass Spec platform leverages well established, gold-standard technology. Mass Spec is already ubiquitous in the laboratory.
Our Strengths We believe the following competitive strengths provide us the ability to provide real-time answers at the point of need in vital health, safety and defense-tech applications: ● Our proprietary microscale Mass Spec platform leverages well established, gold-standard technology. Mass Spec is already ubiquitous in the laboratory.
Sales and Marketing We distribute our devices and consumables via direct field sales and support organizations located in North America and through a combination of our own sales force and more than 60 third party channel partners in domestic and international markets which include Australia, Canada, China, Czech Republic, Germany, Japan, Saudi Arabia, Singapore, Turkey, and the United Kingdom, or UK.
Sales and Marketing We distribute our devices and consumables via direct field sales and support organizations located in North America through a combination of our own sales force and more than 64 third party channel partners in domestic and international markets.
Designed with the non-technical user in mind, the user interface on the MX908 requires no Mass Spec knowledge for navigation, operation or interpretation of results. The MX908 user interface is very mission driven.
Our systems also undergo extensive mechanical shock, drop, vibration, and environmental testing as part of the development and certification process. Designed with the non-technical user in mind, the user interface on the MX908 requires no Mass Spec knowledge for navigation, operation or interpretation of results. The MX908 user interface is very mission driven.
Front-line workers rely upon our handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose. Our desktop devices are accelerating development and production of biotherapeutics by identifying and quantifying extracellular species in bioprocessing critical to cell health and productivity.
Front-line workers rely upon our Mass Spec handheld devices to combat the opioid crisis and to detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels as low as 1,000 times below their lethal dose.
We provide our products to customers pursuant to terms and conditions that impose restrictions on use and disclosure. We also seek to avoid disclosure of our intellectual property using contractual obligations, by requiring employees, consultants and contractors with access to our proprietary information to execute nondisclosure, non-competition and assignment of intellectual property agreements.
We also seek to avoid disclosure of our intellectual property using contractual obligations, by requiring employees, consultants and contractors with access to our proprietary information to execute nondisclosure, non-competition and assignment of intellectual property agreements. In addition, we generally control access to our proprietary and confidential information through the use of internal and external controls.
Using semiconductor microfabrication techniques, we design and produce components that are more than a thousand-fold smaller in volume when compared with most laboratory Mass Spec instruments and costs only 5 Table of Contents dollars to manufacture.
Using semiconductor microfabrication techniques, we design and produce components that are more than a thousand-fold smaller in volume when compared with most laboratory Mass Spec instruments and costs only dollars to manufacture. The vacuum system alone in a typical laboratory instrument weighs hundreds of pounds and requires several hundred watts of power, 24 hours per day, 365 days per year.
We are a technology driven company that has built vertically integrated capabilities to design, manufacture, and commercialize our products. We are led by a dedicated and highly experienced senior management team with significant industry experience and proven ability to deliver novel products. Each member of our senior management team has more than 20 years of relevant experience.
We are led by a dedicated and highly experienced senior management team with significant industry experience and proven ability to deliver novel products. Each member of our senior management team has more than 20 years of relevant experience. Members of our technical team have been collectively responsible for numerous commercial product launches prior to joining the company.
The ThreatID, ProtectIR and XplorIR are manufactured, tested and shipped from our Danbury facility. The Maven and related sampling devices are manufactured, tested and shipped from our Braunschweig facility. Several custom components are fabricated by third party suppliers, including printed circuit boards and cables, and metal and plastic mechanical components.
All facilities are ISO 9001:2015 certified. 12 Table of Contents Devices Our devices are manufactured, tested and shipped from our Danbury manufacturing facility. Several custom components are fabricated by third party suppliers, including printed circuit boards and cables, and some metal and plastic mechanical components.
Achieving that aim requires very sophisticated autonomous and adaptive control systems and the machine learning engine to interpret the data and produce a clear, accurate result.
Achieving that aim requires very sophisticated autonomous and adaptive control systems and the machine learning engine to interpret the data and produce a clear, accurate result. 8 Table of Contents Our devices are designed to provide fast, statistically rigorous answers by providing autonomous control systems and applying rigorous machine learning and analytics methods.
For example, we have relationships with a number of machine shops and electronics suppliers that can provide components for our devices, including components currently provided by a single source. We plan to continue the diversification of our supply chain as we scale.
For example, in addition to our internal precision machining capability, we have relationships with a number of machine shops and electronics suppliers that can provide components for our devices, including components currently provided by a single source. We also have supply agreements in place for critical and/or single-sourced subassemblies such as our Raman spectrometer module.
Our platform is centered around using proprietary microscale Mass Spec, optical spectroscopy, and microfluidic technologies to prepare, separate, and characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, purity, and quantity.
These results are possible as our handheld devices are designed for extreme convenience and speed, requiring minimal training and maintenance. Our platform is centered around using proprietary microscale Mass Spec, and optical 6 Table of Contents spectroscopy to characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, and quantity.
In order to supplement protection of our brand, we have also registered several internet domain names.
Our registered trademarks and pending trademark applications include trademarks for 908 Devices, MX908, VipIR, XplorIR and our logo. In order to supplement protection of our brand, we have also registered several internet domain names.
All these added capabilities are aimed to address gaps in responders’ workflows, increase engagement, and drive utilization.
All these added capabilities are aimed to address gaps in responders’ workflows, increase engagement, and drive utilization. XplorIR The XplorIR is a handheld device that uses FTIR spectroscopy to identify, quantify and track gases and vapors.
Service and Support We offer warranty and extended warranty service plans, as well as on-site training, in order to improve customer adoption of our products. Support under warranty and extended service contracts include the following: ● Technical support.
As a result of these factors, and the budget cycles of our customers, our sales cycle can often be six to twelve months, or longer. Service and Support We offer warranty and extended warranty service plans, as well as on-site training, in order to improve customer adoption of our products.
This is enabled through customer trials and partnerships that allows us to further understand the critical applications for our technology and inform our future developments and market expansion.
This is enabled through customer trials and partnerships that allows us to further understand the critical applications for our technology and inform our future developments and market expansion. 13 Table of Contents Our devices are often sold to governmental institutions and other customers that require participation in a tender process that involves preparation of extensive documentation and a lengthy review process.
Our devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in forensics, bioprocessing, pharma/biopharma, life science research and adjacent markets.
Our devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in vital health, safety and defense tech applications, addressing the fentanyl and illicit drug crisis, toxic carcinogen exposure, and global security threats.
FTIR is an established analytical technology for chemical analysis of solids, liquids and gases. It is highly regarded for its specific substance identification abilities across a broad range of bulk materials. Our FTIR portfolio consists of purpose-built handheld devices that can rapidly identify tens of thousands of bulk chemical substances at the point-of-need.
Our FTIR portfolio consists of purpose-built handheld devices that can rapidly identify tens of thousands of bulk chemical substances at the point-of-need. This technology can measure unknown powders and liquids using an attenuated total reflectance interface, and gases using absorption across a gas cell.
Handheld Devices MX908 Launched in June 2017, MX908 is a handheld, battery-powered, Mass Spec device designed for rapid analysis of solid, liquid, vapor and aerosol materials of unknown identity.
Our devices are changing this paradigm and providing laboratory-like results at the point-of-need. 9 Table of Contents The 908 Devices product suite includes (from left to right): XplorIR, ThreatID, MX908, VipIR, and ProtectIR Devices MX908 Launched in June 2017, MX908 is a handheld, battery-powered, Mass Spec device designed for rapid analysis of solid, liquid, vapor and aerosol materials of unknown identity.
The MX908 is able to start up in less than a minute, completing analysis of gas and vapor materials in less than ten seconds, and solids, liquids, and aerosols in less than a minute.
The MX908 is able to start up in less than a minute, completing analysis of gas and vapor materials in less than ten seconds, and solids, liquids, and aerosols in less than a minute. 10 Table of Contents The MX908 was designed to operate in harsh outdoor environments such as pervasive rain and dust, and scorching to freezing temperatures in a nimble 4.3 kg (approximately 10 lb) handheld form factor.

… 129 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

147 edited+95 added−96 removed283 unchanged
Biggest changeMoreover, disputes may arise with respect to our licensing or other upstream agreements, including: • the scope of rights granted under the agreements and other interpretation-related issues; • the extent to which our systems and consumables, technology and processes infringe on intellectual property rights of the licensor that are not licensed under the licensing agreement; • the sublicensing of patent and other rights under our collaborative development relationships; • our diligence obligations under the license agreements and what activities satisfy those diligence obligations; • the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and • the priority of invention of patented technology. 43 Table of Contents In spite of our efforts to comply with our obligations under our in-bound license agreements, our licensors might conclude that we have materially breached our obligations under our license agreements and might therefore, including in connection with any aforementioned disputes, terminate the relevant license agreement, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.
Biggest changeMoreover, disputes may arise with respect to our licensing or other upstream agreements, including: ● the scope of rights granted under the agreements and other interpretation-related issues; ● the extent to which our systems and consumables, technology and processes infringe on intellectual property rights of the licensor that are not licensed under the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreements and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
Our suppliers may have to temporarily close a facility, face staffing shortages, production slowdowns and stoppages, be overwhelmed by unexpected demand or face disruptions in delivery systems which may require suppliers to locate shipping routes that avoid delivery bottlenecks, all of which could cause delays in delivery.
Our suppliers may temporarily have to close a facility, face staffing shortages, production slowdowns and stoppages, be overwhelmed by unexpected demand or face disruptions in delivery systems which may require suppliers to locate shipping routes that avoid delivery bottlenecks, all of which could cause delays in delivery.
These provisions: • establish a classified board of directors so that not all members of our board are elected at one time; • place limitations on the removal of directors; • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which has the effect of requiring all stockholder actions to be taken at a meeting of stockholders; • establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings; and • enable our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could be used to institute a rights plan, or a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our board of directors.
These provisions: ● establish a classified board of directors so that not all members of our board are elected at one time; ● place limitations on the removal of directors; ● eliminate the ability of our stockholders to call special meetings of stockholders; ● prohibit stockholder action by written consent, which has the effect of requiring all stockholder actions to be taken at a meeting of stockholders; ● establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings; and ● enable our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could be used to institute a rights plan, or a poison pill, which would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our board of directors.
Changes in our products or changes in export regulations may require reclassification and create delays in the introduction and sale of our products in international markets, prevent our customers with international operations from deploying our products throughout their global systems or, in some cases, constrain in some way the export of our products to additional countries.
Changes in our products or changes in export regulations may require reclassification of our products and create delays in the introduction and sale of our products in international markets, prevent our customers with international operations from deploying our products throughout their global systems or, in some cases, constrain in some way the export of our products to additional countries.
We are required to disclose changes made in our internal controls and procedures on a quarterly basis to provide our annual management assessment of our internal control over financial reporting pursuant to Section 404.
We are required to disclose changes made in our internal controls and procedures on a quarterly basis to provide our annual management assessment of our internal control over financial reporting pursuant to Section 404(a).
Any prior acquisitions we have made or future acquisitions we make could subject us to a number of risks, including: • the purchase price we pay could significantly deplete our cash reserves, impair our future operating flexibility or result in dilution to our existing stockholders; • we may find that the acquired company, assets or technology does not further improve our financial and strategic position as planned; • we may find that we overpaid for the company, asset or technology, or that the economic conditions underlying our acquisition have changed; • we may have difficulty integrating the operations and personnel of the acquired company; • we may have difficulty retaining the employees with the technical skills needed to enhance and provide services with respect to the acquired assets or technologies; • the acquisition may be viewed negatively by customers, financial markets, or investors; • we may have difficulty incorporating the acquired technologies or products with our existing products; • we may encounter difficulty entering and competing in new product or geographic markets; • we may encounter a competitive response, including price competition or intellectual property litigation; 59 Table of Contents • we may have product liability, customer liability or intellectual property liability associated with the sale of the acquired company’s products; • we may be subject to litigation by terminated employees or third parties; • we may be subject to additional liabilities that are not possible to be known at the time of the acquisition; • we may incur debt and restructuring charges; • we may acquire goodwill and other intangible assets that are subject to impairment tests, which could result in future impairment charges; • our ongoing business and management’s attention may be disrupted or diverted by transition or integration issues and the complexity of managing geographically or culturally diverse enterprises; and • our due diligence process may fail to identify significant existing issues with the target company’s product quality, product architecture, financial disclosures, accounting practices, internal controls, legal contingencies, intellectual property and other matters.
Any prior acquisitions we have made or future acquisitions we make could subject us to a number of risks, including: ● the purchase price we pay could significantly deplete our cash reserves, impair our future operating flexibility or result in dilution to our existing stockholders; ● we may find that the acquired company, assets or technology does not further improve our financial and strategic position as planned; ● we may find that we overpaid for the company, asset or technology, or that the economic conditions underlying our acquisition have changed; ● we may have difficulty integrating the operations and personnel of the acquired company; ● we may have difficulty retaining the employees with the technical skills needed to enhance and provide services with respect to the acquired assets or technologies; ● the acquisition may be viewed negatively by customers, financial markets, or investors; ● we may have difficulty incorporating the acquired technologies or products with our existing products; ● we may encounter difficulty entering and competing in new product or geographic markets; ● we may encounter a competitive response, including price competition or intellectual property litigation; ● we may have product liability, customer liability or intellectual property liability associated with the sale of the acquired company’s products; ● we may be subject to litigation by terminated employees or third parties; ● we may be subject to additional liabilities that are not possible to be known at the time of the acquisition; ● we may incur debt and restructuring charges; ● we may acquire goodwill and other intangible assets that are subject to impairment tests, which could result in future impairment charges; ● our ongoing business and management’s attention may be disrupted or diverted by transition or integration issues and the complexity of managing geographically or culturally diverse enterprises; and ● our due diligence process may fail to identify significant existing issues with the target company’s product quality, product architecture, financial disclosures, accounting practices, internal controls, legal contingencies, intellectual property and other matters.
Some of the factors that may cause the market price of our common stock to fluctuate, many of which may be beyond our control, include: • actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; • fluctuations in our revenue as a result of our revenue recognition policy, even during periods of significant sales activity; • the financial guidance that we may provide to the public, any changes in such guidance, or our failure to meet such guidance; • changes in financial estimates by securities analysts, our failure to meet such estimates, or failure of analysts to initiate or maintain coverage of our stock; • the public’s response to our press releases or other public announcements by us, including our filings with the SEC; • announcements by us or our competitors of significant technical innovations, products, contracts, acquisitions, strategic partnerships, joint ventures, or capital commitments; • failure of any of our products to achieve or maintain market acceptance; • introduction of technologies or product enhancements that reduce the need for our products; • changes in our capital structure, such as future issuances of securities or the incurrence of debt; • regulatory developments in the United States, foreign countries or both; • litigation involving our company, our general industry or both; • additions or departures of senior management or key personnel; • changes in market valuations of similar companies in reaction to industry events, even if these events do not directly affect us; 50 Table of Contents • investors’ general perception of us; • market volatility or downturns caused by outbreaks, epidemics, pandemics, geopolitical tensions or conflicts, or other macroeconomic dynamics ; • the sustainability of an active trading market for our common stock; and • future sales of our common stock by our officers, directors or affiliates.
Some of the factors that may cause the market price of our common stock to fluctuate, many of which may be beyond our control, include: ● actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; ● fluctuations in our revenue as a result of our revenue recognition policy, even during periods of significant sales activity; ● the financial guidance that we may provide to the public, any changes in such guidance, or our failure to meet such guidance; ● changes in financial estimates by securities analysts, our failure to meet such estimates, or failure of analysts to initiate or maintain coverage of our stock; ● the public’s response to our press releases or other public announcements by us, including our filings with the SEC; ● announcements by us or our competitors of significant technical innovations, products, contracts, acquisitions, strategic partnerships, joint ventures, or capital commitments; ● failure of any of our products to achieve or maintain market acceptance; ● introduction of technologies or product enhancements that reduce the need for our products; ● changes in our capital structure, such as future issuances of securities or the incurrence of debt; ● regulatory developments in the United States, foreign countries or both; ● litigation involving our company, our general industry or both; ● additions or departures of senior management or key personnel; ● changes in market valuations of similar companies in reaction to industry events, even if these events do not directly affect us; ● investors’ general perception of us; ● market volatility or downturns caused by outbreaks, epidemics, pandemics, geopolitical tensions or conflicts, or other macroeconomic dynamics ; ● the sustainability of an active trading market for our common stock; and ● future sales of our common stock by our officers, directors or affiliates.
Therefore, if shortages or delays arise, we may not be able to secure enough components at reasonable prices or of acceptable quality to build new products, resulting in an inability to meet customer demand or our own operating goals, which could adversely affect our customer relationships, business, operating results and financial condition.
If shortages or delays arise, we may not be able to secure enough components at reasonable prices or of acceptable quality to build new products, resulting in an inability to meet customer demand or our own operating goals, which could adversely affect our customer relationships, business, operating results and financial condition.
These and other economic factors can materially adversely affect our business, results of operations, financial condition and stock price. A pandemic, epidemic or outbreak of an infectious disease such as the COVID-19 pandemic may adversely affect our business. Our global operations expose us to risks associated with public health crises and epidemics or pandemics, such as COVID-19.
These and other economic factors can materially adversely affect our business, results of operations, financial condition and stock price. A pandemic, epidemic or outbreak of an infectious disease may adversely affect our business. Our global operations expose us to risks associated with public health crises and epidemics or pandemics, such as COVID-19.
We cannot make any assurances that we will be able to increase our revenue to sustain cash flow from operating activities or reach profitability. As we continue to expand and develop our business, we expect to incur significant additional expenditures in the areas of sales, marketing, research and development, and customer service and support.
We cannot make any assurances that we will be able to increase our revenue to sustain cash flow from operating activities or reach profitability. As we continue to expand and develop our business, we expect to incur significant expenditures in the areas of sales, marketing, research and development, and customer service and support.
Accordingly, our business, financial condition, results of operations, and prospects may be adversely affected by certain events or activities, including, but not limited to: • changes in fiscal or contracting policies or decrease in available government funding; • changes in government programs or applicable requirements; • changes in the political environment, including before or after a change to the leadership within the government administration, and any resulting uncertainty or changes in policy or priorities and resultant funding; • appeals, disputes or litigation relating to government procurement, including but not limited to bid protests by unsuccessful bidders on potential or actual awards of contracts to us or our partners by the government; • the adoption of new laws or regulations or changes to existing laws or regulations; • budgetary constraints, including automatic reductions as a result of “sequestration” or similar measures and constraints imposed by lapses in appropriations for the federal government or certain of its departments and agencies; • influence by, or competition from, third parties with respect to pending, new or existing contracts with government customers; • potential delays or changes in the government appropriations or procurement processes, including as a result of events such as war, incidents of terrorism, natural disasters, and public health concerns or epidemics; and • increased or unexpected costs or unanticipated delays caused by other factors outside of our control, such as performance failures of our partners and subcontractors.
Accordingly, our business, financial condition, results of operations, and prospects may be adversely affected by certain events or activities, including, but not limited to: ● changes in fiscal or contracting policies or decrease in available government funding; ● changes in government programs or applicable requirements; ● changes in the political environment, including before or after a change to the leadership within the government administration, and any resulting uncertainty or changes in policy or priorities and resultant funding; ● appeals, disputes or litigation relating to government procurement, including but not limited to bid protests by unsuccessful bidders on potential or actual awards of contracts to us or our partners by the government; ● the adoption of new laws or regulations or changes to existing laws or regulations; 33 Table of Contents ● budgetary constraints, including automatic reductions as a result of “sequestration” or similar measures and constraints imposed by lapses in appropriations for the federal government or certain of its departments and agencies; ● influence by, or competition from, third parties with respect to pending, new or existing contracts with government customers; ● potential delays or changes in the government appropriations or procurement processes, including as a result of events such as war, incidents of terrorism, natural disasters, and public health concerns or epidemics; and ● increased or unexpected costs or unanticipated delays caused by other factors outside of our control, such as performance failures of our partners and subcontractors.
We are required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting.
We are required to comply with the SEC’s rules implementing Sections 302 and 404(a) of the Sarbanes-Oxley Act, which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting.
Holders of debt would also have rights, preferences or privileges senior to those of holders of our common stock. We have in the past, and may again in the future, engage in future acquisitions that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results.
Holders of debt would also have rights, preferences or privileges senior to those of holders of our common stock. We have in the past, and may again in the future, engage in acquisitions or divestures that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results.
An event of default will occur if, among other things, we fail to make required payments under the Amended 2022 Revolver; we breach any of our covenants under the Amended 2022 Revolver, subject to specified cure periods with respect to certain breaches; the Lender determines that a material adverse change (as defined in the Amended 2022 Revolver) has occurred; we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings; we are unable to pay our debts as they become due; or we default on contracts with third parties which would permit the third party to accelerate the maturity of such indebtedness above certain thresholds or that could have a material adverse effect on our business or operations.
An event of default will occur if, among other things, we fail to make required payments under the Amended 2026 Revolver; we breach any of our covenants under the Amended 2026 Revolver, subject to specified cure periods with respect to certain breaches; the Lender determines that a material adverse change (as defined in the Amended 2026 Revolver) has occurred; we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings; we are unable to pay our debts as they become due; or we default on contracts with third parties which would permit the third party to accelerate the maturity of such indebtedness above certain thresholds or that could have a material adverse effect on our business or operations.
As our industry evolves, our current and potential competitors may establish cooperative relationships among themselves or with third parties, including companies with whom we have partnerships and whose products interoperate with our own, that could acquire significant market share, which could adversely affect our business.
As our industry evolves, our current and potential competitors may establish cooperative relationships among themselves or with third parties, including companies with whom we have partnerships and whose products interoperate with our own, which could acquire significant market share, which could adversely affect our business.
The marketing, sale and use of our products could lead to the filing of product liability claims were someone to allege that our products identified inaccurate or incomplete information regarding the cells analyzed or otherwise failed to perform as designed.
The marketing, sale and use of our products could lead to the filing of product liability claims were someone to allege that our products identified inaccurate or incomplete information regarding the analyzed or otherwise failed to perform as designed.
Any such claims or litigation could: • be time-consuming and expensive to defend, whether meritorious or not; • require us to stop selling, incorporating or using our products that use the other party’s intellectual property; • divert the attention of our technical and managerial resources; • require us to enter into royalty or licensing agreements with third parties, which may not be available on terms that we deem acceptable, if at all; • prevent us from operating all or a portion of our business or force us to redesign our products, which could be difficult and expensive and may degrade performance of our products, or withdraw one or more of our products altogether; • subject us to significant liability for damages or result in significant settlement payments; • require us to indemnify our customers, channel partners or suppliers; and • refund deposits and other amounts received for allegedly infringing technology or products.
Any such claims or litigation could: ● be time-consuming and expensive to defend, whether meritorious or not; ● require us to stop selling, incorporating or using our products that use the other party’s intellectual property; ● divert the attention of our technical and managerial resources; 40 Table of Contents ● require us to enter into royalty or licensing agreements with third parties, which may not be available on terms that we deem acceptable, if at all; ● prevent us from operating all or a portion of our business or force us to redesign our products, which could be difficult and expensive and may degrade performance of our products, or withdraw one or more of our products altogether; ● subject us to significant liability for damages or result in significant settlement payments; ● require us to indemnify our customers, channel partners or suppliers; and ● refund deposits and other amounts received for allegedly infringing technology or products.
The failure to comply with these regulations could result in fines by government authorities and payment of damages to private litigants, which could harm our business. 57 Table of Contents If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company.
The failure to comply with these regulations could result in fines by government authorities and payment of damages to private litigants, which could harm our business. 49 Table of Contents If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company.
For example, factors that may cause our operating results to fluctuate include: • our dependence on a limited number of large orders from U.S. government agencies for a substantial portion of our revenue in any quarterly period, whereby the loss of or delay in a customer order, including as a result of delays in Federal budget approval, or any delay in our fulfillment of deliverables under a customer order, could significantly reduce our revenue for that quarter; • market volatility or downturns caused by outbreaks, epidemics, pandemics, geopolitical tensions or conflicts, or other macroeconomic dynamics; • the addition of new customers or the loss of existing customers; • the rates at which customers purchase additional products or consumables from us; • our ability to enhance our products with new and better functionality that meets customer requirements; • the length and unpredictability of our product sales cycle; • the productivity and growth of our sales force and customer service team; • the effectiveness of our channel partners in securing new orders and fulfilling existing orders; • service interruptions with any of our single source suppliers or subassembly manufacturers; • our ability to attain and maintain production volumes and quality levels for our products, and to accurately forecast customer demand for our products and consumables; • the timing of our product releases or upgrades or related announcements by us or our competitors; • the possibility of seasonality in demand for our products; • changes in pricing by us or our competitors; • the timing of investments in research and development related to new product releases or upgrades; • our ability to control costs, including operating expenses and the costs of the components used in our products; • future accounting pronouncements and changes in accounting policies; • costs related to the acquisition and integration of companies, assets, or technologies; and • general economic, political, or stock market conditions. ​ Our operating expenses are heavily based on our anticipated product revenue growth, especially as we continue to invest significant resources in building out our sales and marketing channels and the development of future products.
For example, factors that may cause our operating results to fluctuate include: ● our dependence on a limited number of large orders from U.S. government agencies for a substantial portion of our revenue in any quarterly period, whereby the loss of or delay in a customer order, including as a result of delays in Federal budget approval, or any delay in our fulfillment of deliverables under a customer order, could significantly reduce our revenue for that quarter; ● market volatility or downturns caused by outbreaks, epidemics, pandemics, geopolitical tensions or conflicts, or other macroeconomic dynamics; ● the addition of new customers or the loss of existing customers; ● the rates at which customers purchase additional products or consumables from us; ● our ability to enhance our products with new and better functionality that meets customer requirements; ● the length and unpredictability of our product sales cycle; ● the productivity and growth of our sales force and customer service team; ● the effectiveness of our channel partners in securing new orders and fulfilling existing orders; ● service interruptions with any of our single source suppliers or subassembly manufacturers; ● our ability to attain and maintain production volumes and quality levels for our products, and to accurately forecast customer demand for our products and consumables; ● the timing of our product releases or upgrades or related announcements by us or our competitors; ● the possibility of seasonality in demand for our products; ● changes in pricing by us or our competitors; ● the timing of investments in research and development related to new product releases or upgrades; ● our ability to control costs, including operating expenses and the costs of the components used in our products; ● future accounting pronouncements and changes in accounting policies; ● costs related to the acquisition and integration of companies, assets, or technologies; and ● general economic, political, or stock market conditions. ​ Our operating expenses are heavily based on our anticipated product revenue growth, especially as we continue to invest in the development of future products.
In addition, it is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act, the CARES Act, or any newly enacted federal tax legislation.
In addition, it is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act, the CARES Act, the OBBB or any newly enacted federal tax legislation.
Our amended and restated bylaws further provide that unless we consent in writing to the selection of an alternative forum, the United States District Court for the District of Massachusetts shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or the Federal Forum Provision, as our headquarters are located in Boston, Massachusetts.
Our amended and restated bylaws further provide that unless we consent in writing to the selection of an alternative forum, the United States District Court for the District of Massachusetts shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or the Federal Forum Provision, as our headquarters are located in Burlington, Massachusetts.
In addition to an adverse impact on demand for our products, uncertainty about, or a decline in, global or regional economic conditions can have a significant impact on our suppliers, 26 Table of Contents manufacturers, logistics providers, channel partners, and other partners. Potential effects include financial instability; inability to obtain credit to finance operations; and insolvency.
In addition to an adverse impact on demand for our products, uncertainty about, or a decline in, global or regional economic conditions can have a significant impact on our suppliers, 18 Table of Contents manufacturers, logistics providers, channel partners, and other partners. Potential effects include financial instability; inability to obtain credit to finance operations; and insolvency.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Cuts and Jobs Act or future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Cuts and Jobs Act, the CARES Act and the OBBB or future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
We may not be able to market, sell or distribute our current and future products effectively enough to support our planned growth. Currently, we sell our products through a combination of direct sales efforts and partnerships with channel partners across all of our key markets. During 2024, our channel partners accounted for a significant portion of our total revenue.
We may not be able to market, sell or distribute our current and future products effectively enough to support our planned growth. Currently, we sell our products through a combination of direct sales efforts and partnerships with channel partners across all of our key markets. During 2025, our channel partners accounted for a significant portion of our total revenue.
In addition, under Sections 382 and 383 of the Internal 60 Table of Contents Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” generally defined as a cumulative change of more than 50 percentage points (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited.
In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” generally defined as a cumulative change of more than 50 percentage points (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited.
With or without insurance, damage to our manufacturing facilities or our other property, or to any of our suppliers, due to fire, flood or other natural disaster or casualty event may have a material adverse effect on our business, financial condition and results of operations. Risks related to sales of products to the U.S.
With or without insurance, damage to our manufacturing facility or our other property, or to any of our suppliers, due to fire, flood or other natural disaster or casualty event may have a material adverse effect on our business, financial condition and results of operations. Risks related to sales of products to the U.S.
Any infringement claim, regardless of its validity, could harm our business by, among other things, resulting in time-consuming and costly litigation, diverting management’s time and attention from the development of the business, requiring the payment of monetary damages (including treble damages, attorneys’ fees, costs and expenses) or royalty 48 Table of Contents payments, or result in potential or existing customers delaying purchases of our products or entering into engagements with us pending resolution of the dispute.
Any infringement claim, regardless of its validity, could harm our business by, among other things, resulting in time-consuming and costly litigation, diverting management’s time and attention from the development of the business, requiring the payment of monetary damages (including treble damages, attorneys’ fees, costs and expenses) or royalty payments, or result in potential or existing customers delaying purchases of our products or entering into engagements with us pending resolution of the dispute.
Our amended and restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for most legal 53 Table of Contents actions involving actions brought against us by stockholders; provided that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware.
Our amended and restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for most legal actions involving actions brought against us by stockholders; provided that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware.
As a result, our employees could leave our company with little or no prior notice and would be free to work for a competitor, subject to the terms of their confidentiality, non-solicitation and intellectual property assignment agreements.
As a result, our employees could leave our company with little or no prior notice and may be free to work for a competitor, subject to the terms of their confidentiality, non-solicitation and intellectual property assignment agreements.
Our contracts with government agencies may subject us to other risks and give the government additional rights and remedies not typically found in commercial contracts, including rights that allow the government to, for example: • obtain detailed cost or pricing information; • receive “most favored customer” pricing; • perform routine audits; • impose equal employment and hiring standards; • require products to be manufactured in specified countries; • restrict non-U.S. ownership or investment in our company; and/or • pursue administrative, civil or criminal remedies for contractual violations.
Our contracts with government agencies may subject us to other risks and give the government additional rights and remedies not typically found in commercial contracts, including rights that allow the government to, for example: ● obtain detailed cost or pricing information; ● receive “most favored customer” pricing; 34 Table of Contents ● perform routine audits; ● impose equal employment and hiring standards; ● require products to be manufactured in specified countries; ● restrict non-U.S. ownership or investment in our company; and/or ● pursue administrative, civil or criminal remedies for contractual violations.
Although we believe our tax estimates are reasonable, if the United States Internal Revenue Service or other taxing authority disagrees with the positions taken on our tax returns, we could have additional tax liability, including interest and penalties.
Although we believe our tax estimates are reasonable, if the United States Internal Revenue Service or another taxing authority disagrees with the positions taken on our tax returns, we could have additional tax liability, including interest and penalties.
Any of these competitive threats, alone or in combination with others, could seriously harm our business, operating results and financial condition. Many of our competitors have greater market presence, longer operating histories, stronger name recognition, larger customer bases and significantly greater financial, technical, sales and marketing, manufacturing, distribution and other resources than we have.
Any of these competitive threats, alone or in combination with others, could seriously harm our business, operating results and financial condition. 22 Table of Contents Many of our competitors have greater market presence, longer operating histories, stronger name recognition, larger customer bases and significantly greater financial, technical, sales and marketing, manufacturing, distribution and other resources than we have.
Any future design issues, unforeseen manufacturing problems, such as contamination of our or such third party facilities, equipment malfunctions, aging components, quality issues with components and materials sourced from third party suppliers, or failures to strictly follow procedures or meet specifications, may have a material adverse effect on our brand, business, financial condition and operating results and could result in us or our third party manufacturers losing International Organization for Standardization, or ISO, quality management certifications.
Any future design issues, unforeseen manufacturing problems, such as contamination of our facilities, equipment malfunctions, aging components, quality issues with components and materials sourced from 24 Table of Contents third party suppliers, or failures to strictly follow procedures or meet specifications, may have a material adverse effect on our brand, business, financial condition and operating results and could result in us losing International Organization for Standardization, or ISO, quality management certifications.
However, these provisions may have the effect of discouraging lawsuits against our directors and officers. The choice of forum provision requiring that the Court of Chancery of the State of Delaware be the exclusive forum for certain actions would not apply to suits brought to enforce any liability or duty created by the Exchange Act.
However, these provisions may have the effect of discouraging lawsuits against our directors and officers. The choice of forum provision requiring that the Court of Chancery of the State of 45 Table of Contents Delaware be the exclusive forum for certain actions would not apply to suits brought to enforce any liability or duty created by the Exchange Act.
A growing number of legislators and regulators are adopting laws and regulations and have focused enforcement efforts on the adoption of artificial intelligence, and use of such technologies in compliance with ethical standards and societal expectations.
A growing number of legislatures and regulators are adopting laws and regulations and have focused enforcement efforts on the adoption of artificial intelligence, and use of such technologies in compliance with ethical standards and societal expectations.
In such an event, our competitors may be able to enter the market without infringing our patents and this circumstance may have a material adverse effect on our business. 44 Table of Contents Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
In such an event, our competitors may be able to enter the market without infringing our patents and this circumstance may have a material adverse effect on our business. Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
The Court of Chancery of the 54 Table of Contents State of Delaware and the United States District Court for the District of Massachusetts may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more or less favorable to us than to our stockholders.
The Court of Chancery of the State of Delaware and the United States District Court for the District of Massachusetts may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more or less favorable to us than to our stockholders.
While we believe that historical experience provides a reliable basis for estimating such warranty costs, unforeseen quality issues or component failure rates could result in future costs in excess 55 Table of Contents of such estimates, or alternatively, improved quality and reliability in our products and consumables could result in actual expenses that are below those currently estimated.
While we believe that historical experience provides a reliable basis for estimating such warranty costs, unforeseen quality issues or component failure rates could result in future costs in excess of such estimates, or alternatively, improved quality and reliability in our products and consumables could result in actual expenses that are below those currently estimated.
Our international operations are subject to a variety of risks that we do not face in the United States, including: • adverse or uncertain macroeconomic conditions, including a global economic downturn or recession; • global impacts of inflation and actions taken by central banks to counter inflation; • the rising cost of labor in the foreign countries in which we and our suppliers operate, resulting in increases in our costs of doing business internationally; • geopolitical conditions, including changes in a specific country's or region's political or economic conditions, including the ongoing military conflict between Russia and Ukraine, and the ongoing hostilities in Israel and the Gaza Strip, and the threat that such conflicts could spread to other parts of Europe and the Middle East; • the difficulty of increased travel, infrastructure and legal compliance costs associated with developing international revenue; • difficulties in enforcing contracts, collecting accounts receivable and longer payment cycles, especially in emerging markets; • many, if not most, foreign governments are investing less in safety and security and in technology to detect dangerous chemicals than the U.S. government; • additional withholding taxes or other taxes on our foreign income, and tariffs or other restrictions on foreign trade or investment; • compliance with privacy and data security requirements in foreign jurisdictions in which we operate; • imposition of, or unexpected adverse changes in, foreign laws or regulatory requirements, many of which differ from those in the United States; • costs and delays associated with developing products or technology in multiple languages, such as the software embedded in our products and the products’ built-in library of chemical substances; • compliance with foreign technical standards; • increased length of time for shipping and acceptance of our products; • increased exposure to foreign currency exchange rate risk; • reduced protection for intellectual property rights in some countries; and • political unrest, war, incidents of terrorism , natural disasters, and public health concerns or epidemics, or responses to such events.
Our international operations are subject to a variety of risks that we do not face in the United States, including: • adverse or uncertain macroeconomic conditions, including a global economic downturn or recession; • global impacts of inflation and actions taken by central banks to counter inflation; • the rising cost of labor in the foreign countries in which we and our suppliers operate, resulting in increases in our costs of doing business internationally; • geopolitical conditions, including changes in a specific country's or region's political or economic conditions, including the ongoing military conflict between Russia and Ukraine or the conflicts in the Middle East ; • the difficulty of increased travel, infrastructure and legal compliance costs associated with developing international revenue; • difficulties in enforcing contracts, collecting accounts receivable and longer payment cycles, especially in emerging markets; • many, if not most, foreign governments are investing less in safety and security and in technology to detect dangerous chemicals than the U.S. government; • additional withholding taxes or other taxes on our foreign income, and tariffs or other restrictions on foreign trade or investment; • compliance with privacy and data security requirements in foreign jurisdictions in which we operate; • imposition of, or unexpected adverse changes in, foreign laws or regulatory requirements, many of which differ from those in the United States; • costs and delays associated with developing products or technology in multiple languages, such as the software embedded in our products and the products’ built-in library of chemical substances; • compliance with foreign technical standards; • increased length of time for shipping and acceptance of our products; 31 Table of Contents • increased exposure to foreign currency exchange rate risk; • reduced protection for intellectual property rights in some countries; and • political unrest, war, incidents of terrorism , natural disasters, and public health concerns or epidemics, or responses to such events.
Moreover, global capital markets have undergone periods of significant volatility and uncertainty in the past, and there can be no assurance that such financing alternatives will be available to us on favorable terms or at all, should we determine it necessary or advisable to seek additional capital.
Moreover, global capital markets have undergone periods of significant volatility and uncertainty in the past, and there 50 Table of Contents can be no assurance that such financing alternatives will be available to us on favorable terms or at all, should we determine it necessary or advisable to seek additional capital.
Further, bad actors around the world use increasingly 38 Table of Contents sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
Further, bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
For 40 Table of Contents example, we have historically derived, and expect to continue to derive, a significant portion of our revenue from sales to agencies of the U.S. federal government, either directly by us or through other channel partners. Sales to such government agencies are subject to a number of challenges and risks.
For example, we have historically derived, and expect to continue to derive, a significant portion of our revenue from sales to agencies of the U.S. federal government, either directly by us or through other channel partners. Sales to such government agencies are subject to a number of challenges and risks.
In addition, the continued development of complementary software tools, such as our analysis tools and visualization software, requires us to compete for highly trained software engineers in the Boston area and for highly trained customer service personnel globally. We do not have fixed term employment contracts with any of our employees.
In addition, the continued development of complementary software tools, such as our analysis tools and visualization software, requires us to compete for highly trained software engineers in the New England area and for highly trained customer service personnel globally. We do not have fixed term employment contracts with any of our employees.
Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products. As the biotechnology industry expands and more patents are issued, the risk increases that our products may be subject to claims of infringement of the patent rights of third parties.
Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products. As more patents are issued, the risk increases that our products may be subject to claims of infringement of the patent rights of third parties.
Projections are based upon a number of assumptions and estimates that, while presented with numerical specificity, are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control and are based upon specific assumptions with respect to future business decisions, some of which will change.
Projections are based upon a number of assumptions and estimates that, while presented with numerical specificity, are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which 43 Table of Contents are beyond our control and are based upon specific assumptions with respect to future business decisions, some of which will change.
Our reliance on independent channel 56 Table of Contents partners to sell our products internationally demands a high degree of vigilance in maintaining our policy against participation in corrupt activity, because these channel partners could be deemed to be our agents and we could be held responsible for their actions.
Our reliance on independent channel partners to sell our products internationally demands a high degree of vigilance in maintaining our policy against participation in corrupt activity, because these channel partners could be deemed to be our agents and we could be held responsible for their actions.
Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.
Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, 36 Table of Contents regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.
There is a substantial amount of litigation and other patent challenges, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology industry, including patent infringement lawsuits, interferences, oppositions and inter partes review proceedings before the USPTO, and corresponding foreign patent offices.
There is a substantial amount of litigation and other patent challenges, both within and outside the United States, involving patent and other intellectual property rights, including patent infringement lawsuits, interferences, oppositions and inter partes review proceedings before the USPTO, and corresponding foreign patent offices.
Accordingly, high quality customer service is important for the growth of our business and any failure to maintain such standards of customer service, or a related market perception, could affect our ability to sell products to existing and prospective customers.
Accordingly, high quality customer service is important for the growth of our business and any failure to maintain such 46 Table of Contents standards of customer service, or a related market perception, could affect our ability to sell products to existing and prospective customers.
In addition, the strain on certain domestic and international supply chains from public health crises and epidemics or pandemics, such as COVID-19, could result in production slowdowns, longer lead times and negative impacts on pricing for certain of our critical components, including, among other things, electronic and plastic components necessary to manufacture our products.
In addition, the strain on certain domestic and international supply chains from public health crises and epidemics or pandemics could result in production slowdowns, longer lead times and negative impacts on pricing for certain of our critical components, including, among other things, electronic and plastic components necessary to manufacture our products.
While we have attempted to secure business liability insurance coverage at appropriate cost, it is impossible to insure against all risks inherent in our industry, nor can we assure you that our insurers will pay a particular claim, or that we will be able to maintain coverage at reasonable rates in the future.
While we have attempted to secure business liability insurance coverage at appropriate cost, it is impossible to insure against all risks inherent in our industry, nor can we assure you that our insurers will pay a 47 Table of Contents particular claim, or that we will be able to maintain coverage at reasonable rates in the future.
If our customers experienced a shortage or delay in consumables, such as swab samplers, microfluidic chips, or assay kits, or if these consumables do not perform at the levels our customers expect, our business could be materially and adversely impacted. In addition, we maintain relatively low inventory and acquire components based upon anticipated annual demand.
If our customers experienced a shortage or delay in consumables, such as swab samplers or if these consumables do not perform at the levels our customers expect, our business could be materially and adversely impacted. In addition, we maintain relatively low inventory and acquire components based upon anticipated annual demand.
We cannot assure investors that we and our third party manufacturers will be able to launch new products on time, transition manufacturing of existing products to new manufacturers, transition our manufacturing capabilities to a new location or transition manufacturing of any additional consumables in-house without manufacturing defects.
We cannot assure investors that we will be able to launch new products on time, transition manufacturing of existing products to new manufacturers, transition our manufacturing capabilities to a new location or transition manufacturing of any additional consumables in-house without manufacturing defects.
Federal Reserve, along with other central banks around the world, may further negatively affect our short-term ability or desire to incur debt. A failure to 58 Table of Contents obtain additional funding could prevent us from making expenditures that may be required to grow or maintain our operations.
Federal Reserve, along with other central banks around the world, may further negatively affect our short-term ability or desire to incur debt. A failure to obtain additional funding could prevent us from making expenditures that may be required to grow or maintain our operations.
If we were to come under foreign ownership, control or influence, our U.S. government customers could terminate, or decide not to renew, our contracts, or we may be subjected to burdensome industrial security compliance measures. Such a situation could impair our ability to obtain new contracts and subcontracts.
If we were to come under foreign ownership, control or influence, our U.S. 35 Table of Contents government customers could terminate, or decide not to renew, our contracts, or we may be subjected to burdensome industrial security compliance measures. Such a situation could impair our ability to obtain new contracts and subcontracts.
We may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time any such event of default occurs.
We may not have enough available cash or be able to raise additional funds through 32 Table of Contents equity or debt financings to repay such indebtedness at the time any such event of default occurs.
There is no certainty that we will effectively identify these trends and needs or introduce products that are successful. We need to continue to build and develop our sales, marketing and customer service organization, and to engage with domestic and international channel partners to support our planned growth.
There is no certainty that we will effectively identify these trends and needs or introduce products that are successful. 21 Table of Contents We need to continue to build and develop our sales, marketing and customer service organization, and to engage with domestic and international channel partners to support our planned growth.
Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the Tax Cuts and Jobs Act significantly revised the Code.
Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the Tax Cuts and Jobs Act and other recent tax legislation significantly revised the Code.
As a result, we could be subject to lawsuits and other allegations by parties claiming ownership of what we believe to be open source software or claiming noncompliance with open source 49 Table of Contents licensing terms.
As a result, we could be subject to lawsuits and other allegations by parties claiming ownership of what we believe to be open source software or claiming noncompliance with open source licensing terms.
These adverse economic conditions include inflation, slower growth or recession, new or increased tariffs and other changes to fiscal and monetary policy, higher interest rates, high unemployment, decreased consumer confidence in the economy, armed hostilities, such as the ongoing military conflict between Russia and Ukraine, the ongoing hostilities in Israel and the Gaza Strip, foreign currency exchange rate fluctuations, and other matters that influence consumer spending and preferences.
These adverse economic conditions include inflation, slower growth or recession, new or increased tariffs and other changes to fiscal and monetary policy, higher interest rates, high unemployment, decreased consumer confidence in the economy, armed hostilities, such as the ongoing military conflict between Russia and Ukraine or the conflicts in the Middle East, foreign currency exchange rate fluctuations, and other matters that influence consumer spending and preferences.
Moreover, the rights granted under any issued patents may not provide us with proprietary protection or competitive advantages, and, as with any technology, competitors may be able to develop and obtain patents for technologies that are similar to or superior to our technologies.
Moreover, the rights granted under any issued patents may not provide us with proprietary protection or 38 Table of Contents competitive advantages, and, as with any technology, competitors may be able to develop and obtain patents for technologies that are similar to or superior to our technologies.
The legal systems of many other countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the misappropriation or other violations of our intellectual property rights including infringement of our patents in such countries.
The legal systems of many other countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the misappropriation or other violations of our intellectual property rights including infringement of our patents in such countries.
There is no assurance that we or our third party manufacturers will be able to continue to manufacture our products so that they consistently achieve the product specifications and quality that our customers expect.
There is no assurance that we will be able to continue to manufacture our products so that they consistently achieve the product specifications and quality that our customers expect.
As we continue to scale our business, we may find that certain of our products, certain customers or certain markets, including the biopharmaceutical market, may require a dedicated sales force or sales personnel with different experience than those whom we currently employ.
As we continue to scale our business, we may find that certain of our products and certain customers or certain markets, may require a dedicated sales force or sales personnel with different experience than those whom we currently employ.
Other parties may not comply with the terms of their agreements with us, and we may not be able to enforce our rights adequately against these parties. 45 Table of Contents Although we enter into confidentiality, assignments of proprietary rights and license agreements, as appropriate, with our employees and third parties, including our contract manufacturers, contract engineering firms, and generally control access to and distribution of our technologies, documentation and other proprietary information, we cannot be certain that the steps we take to prevent unauthorized use of our intellectual property rights are sufficient to prevent their misappropriation, particularly in foreign countries where laws or law enforcement practices may not protect our intellectual property rights as fully as in the United States.
Although we enter into confidentiality, assignments of proprietary rights and license agreements, as appropriate, with our employees and third parties, including our contract manufacturers, contract engineering firms, and generally control access to and distribution of our technologies, documentation and other proprietary information, we cannot be certain that the steps we take to prevent unauthorized use of our intellectual property rights are sufficient to prevent their misappropriation, particularly in foreign countries where laws or law enforcement practices may not protect our intellectual property rights as fully as in the United States.
If we fail to maintain significant market acceptance in existing markets or fail to successfully increase our penetration in new and expanding markets, we will not generate expected revenue and our prospects may be harmed. In 2024, a majority of our revenue was derived from sales of our handheld products.
If we fail to maintain significant market acceptance in existing markets or fail to successfully increase our penetration in new and expanding markets, we will not generate expected revenue and our prospects may be harmed. In 2025, substantially all of our revenue was derived from sales of our handheld products.
Additionally, as we expand our non-U.S. operations, a larger portion of our operating expenses may be denominated in local currencies. Therefore, increases in the value of the U.S. dollar and decreases in the value of foreign currencies could result in the dollar equivalent of our revenue being lower.
Additionally, if we were to expand our non-U.S. operations, a larger portion of our operating expenses and potentially our contracts may be denominated in local currencies. Therefore, increases in the value of the U.S. dollar and decreases in the value of foreign currencies could result in the dollar equivalent of our revenue being lower.
We also expect 30 Table of Contents additional competition in the future from new and existing companies with whom we do not currently compete directly.
We also expect additional competition in the future from new and existing companies with whom we do not currently compete directly.
If market demand for our MX908 product declines, if our products fail to maintain or achieve greater market acceptance, or if we fail to execute on our sales and customer service efforts in the field forensics market, we will not be able to grow our revenue sufficiently to achieve or maintain profitability.
If market demand for our products declines, if our products fail to maintain or achieve greater market acceptance, or if we fail to execute on our sales and customer service efforts, we will not be able to grow our revenue sufficiently to achieve or maintain profitability.
Future guidance from the Internal Revenue Service and other tax authorities with respect to the Tax Cuts and Jobs Act may affect us, and certain aspects of the Tax Cuts and Jobs Act could be repealed or modified in future legislation. For example, the CARES Act modified certain provisions of the Tax Cuts and Jobs Act.
Future guidance from the Internal Revenue Service and other tax authorities with respect to the Tax Cuts and Jobs Act and other recent tax legislation may affect us, and certain aspects of the Tax Cuts and Jobs Act or such tax legislation could be repealed or modified in future legislation.
We are permitted to make interest-only payments on the revolving line of credit through November 3, 2025, at which time all outstanding indebtedness shall be immediately due and payable. However, we may be required to repay the outstanding indebtedness under the revolving line of credit if an event of default occurs under the Amended 2022 Revolver.
We are permitted to make interest-only payments on the revolving line of credit through March 5, 2028, at which time all outstanding indebtedness shall be immediately due and payable. However, we may be required to repay the outstanding indebtedness under the revolving line of credit if an event of default occurs under the Amended 2026 Revolver.
Neither we nor our contract manufacturers enter into long-term supply contracts for these components, and none of our third party suppliers is obligated to supply products to us for any specific period or in any specific quantities, except as may be provided in a particular purchase order.
In most cases, we do not enter into long-term supply contracts for these components, and none of our third-party suppliers is obligated to supply products to us for any specific period or in any specific quantities, except as may be provided in a particular purchase order.
We face substantial competition from very large and experienced enterprises, both public and privately held, including Agilent Technologies, Bruker Corporation, Danaher Corporation, Inficon, Teledyne, Endress & Hauser, PerkinElmer, Shimadzu Corporation, Thermo Fisher Scientific, and Waters Corp. Our competitors also include many smaller companies, including companies established to pursue new and emerging technologies.
We face substantial competition from very large and experienced enterprises, both public and privately held, including Agilent Technologies, Bruker Corporation, Inficon, Teledyne, Thermo Fisher Scientific and Rigaku. Our competitors also include many smaller companies, including companies established to pursue new and emerging technologies.
Our future plans include significant investments in research and development of product opportunities for expansion of our handheld products and new application areas for our desktop products. We believe that we must continue to dedicate a significant amount of resources to our research and development efforts to maintain our competitive position.
Our future plans include significant investments in research and development of product opportunities for expansion of our handheld products. We believe that we must continue to dedicate a significant amount of resources to our research and development efforts to maintain 25 Table of Contents our competitive position.
A change in these principles or interpretations could have a significant effect on our reported financial results, and they could affect the reporting of transactions completed before the announcement of a change. ​
A change in these principles or interpretations could have a significant effect on our reported financial results, and they could affect the reporting of transactions completed before the announcement of a change. ​ Item 1B. Unresolved Staff Comments. None. ​
Government A significant percentage of our revenue is generated from agencies and departments of the U.S. government. In addition, substantially all of our revenue from license and contracts revenue are derived from contracts or sub-contracts related to the U.S. government. We expect significant revenue from U.S. government contracts for the foreseeable future.
Government A significant percentage of our revenue is generated from agencies and departments of the U.S. government. In addition, a substantial amount of our licensing and sales revenue are derived from contracts or sub-contracts related to the U.S. government. We expect significant revenue from U.S. government contracts for the foreseeable future.
We may be subject to governmental export controls that could impair our ability to compete in international markets. We are subject to governmental export controls that could impair our ability to compete in international markets.
We may be subject to governmental export controls and economic sanctions that could impair our ability to compete in international markets.
As a contractor and subcontractor to the U.S. government, we are subject to various laws and regulations that are more restrictive than those applicable to non-government contractors, including the Federal Acquisition Regulations and 42 Table of Contents its supplements, which comprehensively regulate the formation, administration and performance of U.S. government contracts, and the Truth in Negotiations Act and various other laws, which require certain certifications and disclosures.
As a contractor and subcontractor to the U.S. government, we are subject to various laws and regulations that are more restrictive than those applicable to non-government contractors, including the Federal Acquisition Regulations and its supplements, which comprehensively regulate the formation, administration and performance of U.S. government contracts, and the Truthful Cost or Pricing Data Act and various other laws, which require certain certifications and disclosures.
Managing our growth effectively will involve, among other things: • continuing to retain, motivate, and manage our existing employees and attract and integrate new employees, particularly qualified sales personnel; • continuing to provide a high level of service to an increasing number of customers; • maintaining the quality of product and services offerings while controlling our expenses; • meeting end-user requirements for functional performance and product robustness; 28 Table of Contents • growing our direct sales force and channel partners; and • developing, implementing, and improving our operational, financial, accounting, and other internal systems and controls on a timely basis.
Managing our growth effectively will involve, among other things: ● continuing to retain, motivate, and manage our existing employees and attract and integrate new employees, particularly qualified sales personnel; ● continuing to provide a high level of service to an increasing number of customers; ● maintaining the quality of product and services offerings while controlling our expenses; ● meeting end-user requirements for functional performance and product robustness; ● growing our direct sales force and channel partners; and ● developing, implementing, and improving our operational, financial, accounting, and other internal systems and controls on a timely basis. 20 Table of Contents If demand for our products increases rapidly, we will need to expand internal production capacity or implement additional outsourcing of components and/or our assembled products.
Future outbreaks of infectious disease, such as COVID 19, and any future variants or subvariants that may emerge, may disrupt operations of our customers and prospective customers including as a result of travel restrictions and/or business shutdowns, uncertainty in the financial markets or other harm to their business and financial results.
Future outbreaks of infectious disease, may disrupt operations of our customers and prospective customers including as a result of travel restrictions and/or business shutdowns, uncertainty in the financial markets or other harm to their business and financial results.

… 258 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

4 edited+14 added−10 removed0 unchanged
Biggest changeItem 1C. Cybersecurity. Governance Related to Cybersecurity Risks Our board of directors, as a whole and through its committees, holds overall oversight responsibility for our risk management processes, including in relation to risks from cybersecurity threats.
Biggest changeOur actual or perceived failure (or that of the third parties with whom we work) to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.” Governance Related to Cybersecurity Risks Our board of directors, as a whole and through its committees, holds overall oversight responsibility for our risk management processes, including in relation to risks from cybersecurity threats.
As part of our cybersecurity risk management program, we have a process to assess and review the cybersecurity practices of major third-party vendors and service providers that access, process, collect, share, create, store, transmit or destroy our information or have access to our systems, including through review of applicable certifications, and security reports, and contractual requirements, as appropriate.
For example, as part of our cybersecurity risk management program, we have a process to assess and review the cybersecurity practices of major third-party vendors and service providers that access, process, collect, share, create, store, transmit or destroy our information or have access to our systems, including through review of applicable certifications, and security reports, and contractual requirements, as appropriate.
We also work with external security service providers to support our security monitoring and threat detection capabilities and have implemented a process to report relevant findings to the Director of Information Technology and up to the Chief Product Officer and other members of executive management, where appropriate.
We also work with external security service providers to support our security monitoring and threat detection capabilities and have implemented a process to report relevant findings to the Senior Director of Information Technology and other members of executive management, where appropriate.
The audit committee receives quarterly reports from our Director of Information Technology on the status of our cybersecurity program, including measures implemented to monitor and address cybersecurity risks and threats, as appropriate. The Chair of the audit committee provides a quarterly report to the board of directors, which includes any key updates on cybersecurity matters, as applicable.
Our board of directors exercises its oversight function through the audit committee, which oversees the management of risk exposure across various areas, including cybersecurity risks. The audit committee receives quarterly reports from our Senior Director of Information Technology on the status of our cybersecurity program, including measures designed to monitor and address cybersecurity risks and threats, as appropriate.
Removed
Our board of directors exercises its oversight function through the audit committee, which oversees the management of risk exposure across various areas, including cybersecurity risks, in accordance with its charter.
Added
Cybersecurity Risk Management and Strategy We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property and confidential information that is proprietary, strategic or competitive in nature (collectively, Information Systems and Data). 53 Table of Contents Our Senior Director of Information Technology and our incident response team are tasked with helping to identify, assess and manage the Company’s cybersecurity threats and risks.
Removed
Our Director of Information Technology is responsible for the day-to-day administration and management of our cybersecurity program, under the direct supervision of our Chief Product Officer (formerly our Chief Technology Officer). Currently, the Director of Information Technology role is held by an individual who has approximately 20 years of information technology experience and 11 years of cybersecurity experience.
Added
They identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment and the Company’s risk profile using various methods including, for example: manual tools, automated tools, subscribing to reports and services that identify cybersecurity threats, conducting scans of the threat environment, internal and external audits, and conducting vulnerability assessments to identify vulnerabilities.
Removed
Cybersecurity Risk Management and Strategy We maintain a cybersecurity program, which is informed by industry standards, that includes processes for identification, assessment, and management of cybersecurity risks. We conduct periodic risk assessments, including with support from external vendors, to assess our cyber program, identify potential areas of enhancement, and develop strategies for the mitigation of cyber risks.
Added
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: incident response plans , disaster recovery and business continuity plans, risk assessments, encryption of data, network security controls, data segregation, access controls, physical security measures, systems monitoring, employee training, penetration testing, cybersecurity insurance, as well as asset management, tracking and disposal.
Removed
We also conduct regular security testing and have established a vulnerability management process, supported by security testing, that is designed to address the treatment of identified security risks based on severity.
Added
Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes.
Removed
We have implemented a process to periodically conduct security awareness training for employees and simulated phishing campaigns. We also conduct specific training and tabletop exercises for key personnel involved in cybersecurity risk management.
Added
From time to time, we use third-party service providers to assist us in an effort to identify, assess, and manage material risks from cybersecurity threats, including, for example: cybersecurity software providers, managed cybersecurity service providers, and penetration testing firms. We use third-party service providers to perform a variety of functions throughout our business, such as application providers and hosting companies.
Removed
Our Director of Information Technology and his team are informed about and monitor the prevention, detection, mitigation, and remediation of cybersecurity risks through various means, including by leveraging a managed security service provider and other third-party security software and technology services.
Added
We have a vendor management program designed to manage cybersecurity risks associated with our use of these providers, which includes, as appropriate, a review of the relevant vendor’s security program.
Removed
In addition, we use various internal and external processes and technologies, including third-party security solutions, monitoring, and alerting tools and resources, designed to monitor, identify, and address risks from cybersecurity threats. We also have implemented processes and technologies for network monitoring and data loss prevention procedures.
Added
Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, our vendor management process may involve different levels of assessment designed to help identify cybersecurity risks associated with a provider and impose contractual obligations related to cybersecurity on the provider.
Removed
We have adopted an incident response plan to guide us in responding to cybersecurity incidents and maintain processes to inform and update executive management and the audit committee about security incidents that may pose a significant risk for our business, as applicable.
Added
For a description of the risks from cybersecurity threats that may materially affect the Company and how they may do so, see our risk factors under Part 1. Item 1A.
Removed
We have not identified any cybersecurity incidents or threats that have materially affected us or are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition ; however, like other companies in our industry, we and our third-party vendors may, from time to time, experience threats and security 62 Table of Contents incidents relating to our and our third-party vendors’ information systems.
Added
Risk Factors in this Annual Report on Form 10-K, including “We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
Removed
See Item 1A “Risk Factors” in this Annual Report on Form 10 K for more information. ​
Added
The Chair of the audit committee provides a quarterly report to the board of directors, which includes updates on certain cybersecurity matters, as applicable.
Added
Our Senior Director of Information Technology is responsible for the day-to-day administration and management of our cybersecurity program, including hiring appropriate personnel, helping to integrate cybersecurity risk considerations 54 Table of Contents into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel.
Added
The Senior Director of Information Technology is also responsible for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports. Our Senior Director of Information Technology has approximately 21 years of information technology experience, including 12 years of cybersecurity experience.
Added
Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our Chief Financial Officer and Chief Legal and Administrative Officer, who work with the Company’s incident response team to help the Company respond to, mitigate and remediate cybersecurity incidents of which they are notified.
Added
In addition, the Company’s incident response processes include reporting to the audit committee of the board of directors for certain cybersecurity incidents.

Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−0 removed0 unchanged
Biggest changeWe maintained the following principal facilities as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ Location ​ Functions ​ Square Footage (Approx.) ​ Lease Expiration Boston, Massachusetts ​ Corporate headquarters, R&D, assembly, manufacturing ​ 37,500 ​ October 2025 Morrisville, North Carolina ​ R&D, assembly, manufacturing ​ 13,300 ​ July 2030 Danbury, Connecticut ​ R&D, assembly, manufacturing ​ 38,200 ​ July 2034 Braunschweig, Germany ​ Office, R&D, assembly, manufacturing ​ 7,500 ​ January 2028 ​ We believe that our current facilities meet our anticipated needs for the foreseeable future. ​ ​ ​
Biggest changeWe maintained the following principal facilities as of December 31, 2025: ​ ​ ​ ​ ​ ​ ​ Location ​ Functions ​ Square Footage (Approx.) ​ Lease Expiration Burlington, Massachusetts ​ Corporate headquarters, R&D ​ 12,800 ​ July 2029 Danbury, Connecticut ​ R&D, assembly, manufacturing ​ 38,200 ​ July 2034 Georgetown, Massachusetts ​ assembly, manufacturing ​ 3,500 ​ February 2030 Stamford, Connecticut ​ assembly, manufacturing ​ 11,500 ​ March 2028 ​ We believe that our current facilities meet our anticipated needs for the foreseeable future. ​
Item 2. Properties. Our corporate headquarters are currently located in Boston, Massachusetts.
Item 2. Properties. Our corporate headquarters are currently located in Burlington, Massachusetts.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added−0 removed1 unchanged
Biggest changeNot applicable. ​ 63 Table of Contents PART II
Biggest changeNot applicable. ​ 55 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+16 added−2 removed3 unchanged
Biggest changeSecurities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference.
Biggest changeSecurities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference. Recent Sales of Unregistered Equity Securities None. Issuer Purchases of Equity Securities None.
Our ability to pay cash dividends is currently restricted by the terms of our Amended 2022 Revolver with Silicon Valley Bank. In addition, the terms of any future debt instruments may also materially restrict our ability to pay dividends on our common stock.
Our ability to pay cash dividends is currently restricted by the terms of the Amended 2026 Revolver with Silicon Valley Bank. In addition, the terms of any future debt instruments may also materially restrict our ability to pay dividends on our common stock.
Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant. ​ ​
Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant. ​ ​ Item 6. Reserved.
Removed
Prior to that time, there was no established public market for our common stock. Holders of Our Common Stock As of March 3, 2025, there were approximately 33 holders of record of our common stock.
Added
Prior to that time, there was no established public market for our common stock. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance.
Removed
Recent Sales of Unregistered Equity Securities We did not issue or grant any equity securities during the period covered by this Annual Report on Form 10-K that were not registered under the Securities Act. Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report on Form 10-K.
Added
All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy and plans and our objectives for future operations, are forward-looking statements, and are made under the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Added
The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “could,” “target,” “predict,” “seek” and similar expressions are intended to identify forward-looking statements.
Added
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs.
Added
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Summary of Risk Factors,” Part I, Item 1A “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time.
Added
It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make.
Added
In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Annual Report on Form 10-K may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Added
The forward-looking statements included in this Annual Report on Form 10-K are made only as of the date of this report. You should not rely upon forward-looking statements as predictions of future events.
Added
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements.
Added
We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Annual Report on Form 10-K to conform these statements to actual results or to changes in our expectations.
Added
The market data and certain other statistical information used throughout this Annual Report on Form 10-K are based on independent industry publications, governmental publications, reports by market research firms or other independent sources that we believe to be reliable sources. Some data are also based on our good faith estimates.
Added
Industry publications and third party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information.
Added
We are responsible for all of the disclosure contained in this Annual Report on Form 10-K, and we believe these industry publications and third party research, surveys and studies are reliable.
Added
While we are not aware of any misstatements regarding any third party information presented in this Annual Report on Form 10-K, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those described in Part I, Item 1A “Risk Factors” in this Annual Report on Form 10-K. 56 Table of Contents Investors and others should note that we may announce material business and financial information to our investors using our investor relations website (ir.908devices.com), our filings with the Securities and Exchange Commission, or SEC, webcasts, press releases, and conference calls.
Added
We use these mediums, including our website, to communicate with investors and the general public about our company, our products, and other issues. It is possible that the information that we make available on our website may be deemed to be material information.
Added
We therefore encourage investors and others interested in our company to review the information that we make available on our website. Holders of Our Common Stock As of March 4, 2026, there were approximately 17 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

98 edited+16 added−30 removed71 unchanged
Biggest changeThe following tables set forth our results of operations for the periods presented: Comparison of the Years ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2024 2023 Change ​ ​ (in thousands) Revenue: ​ ​ ​ ​ ​ ​ Product revenue ​ $ 43,922 ​ $ 40,214 ​ $ 3,708 Service and contract revenue ​ ​ 15,709 ​ ​ 10,015 ​ ​ 5,694 Total revenue ​ 59,631 ​ 50,229 ​ 9,402 Cost of revenue: ​ ​ ​ Product cost of revenue ​ 21,645 ​ 18,428 ​ 3,217 Service and contract cost of revenue ​ ​ 8,130 ​ ​ 6,479 ​ ​ 1,651 Total cost of revenue ​ 29,775 ​ 24,907 ​ 4,868 Gross profit ​ 29,856 ​ 25,322 ​ 4,534 Operating expenses: ​ ​ ​ Research and development ​ 25,495 ​ 21,904 ​ 3,591 Selling, general and administrative ​ 53,636 ​ 46,069 ​ 7,567 Change in fair value of contingent consideration ​ (13,216) ​ 107 ​ (13,323) Goodwill impairment ​ 40,659 ​ — ​ 40,659 Total operating expenses ​ 106,574 ​ 68,080 ​ 38,494 Loss from operations ​ (76,718) ​ (42,758) ​ (33,960) Other income, net: ​ ​ ​ Interest income ​ ​ 4,494 ​ ​ 6,480 ​ ​ (1,986) Interest expense ​ — ​ (201) ​ 201 Other expense, net ​ ​ (264) ​ (131) ​ (133) Total other income, net ​ 4,230 ​ 6,148 ​ (1,918) Loss from operations before income taxes ​ ​ (72,488) ​ ​ (36,610) ​ ​ (35,878) Benefit for income taxes ​ ​ 282 ​ ​ 211 ​ ​ 71 Net loss ​ $ (72,206) ​ $ (36,399) ​ $ (35,807) ​ 73 Table of Contents Revenue, Cost of revenue and Gross profit Product Our product revenue is comprised of revenue from sales of devices and related accessories and consumables and service as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ 2024 2023 Amount % ​ ​ (dollars in thousands) Product revenue ​ $ 43,922 ​ $ 40,214 ​ $ 3,708 9 % Product cost of revenue ​ 21,645 ​ 18,428 ​ 3,217 17 % Gross profit ​ $ 22,277 ​ $ 21,786 ​ $ 491 2 % Gross profit margin ​ 51 % 54 % (3) % ​ ​ Product revenue increased by $3.7 million, or 9%, for the year ended December 31, 2024, compared to the year ended December 31, 2023.
Biggest changeThe following tables set forth our results of operations for the periods presented: 65 Table of Contents Comparison of the Years ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Change ​ ​ (in thousands) Revenue: ​ ​ ​ ​ ​ ​ ​ ​ ​ Product revenue ​ $ 43,281 ​ $ 35,530 ​ $ 7,751 Service and contract revenue ​ ​ 12,916 ​ ​ 12,216 ​ ​ 700 Total revenue ​ 56,197 ​ 47,746 ​ 8,451 Cost of revenue: ​ ​ ​ ​ ​ ​ Product cost of revenue ​ 22,325 ​ 17,387 ​ 4,938 Service and contract cost of revenue ​ ​ 5,449 ​ ​ 5,859 ​ ​ (410) Total cost of revenue ​ 27,774 ​ 23,246 ​ 4,528 Gross profit ​ 28,423 ​ 24,500 ​ 3,923 Operating expenses: ​ ​ ​ ​ ​ ​ Research and development ​ 15,575 ​ 14,988 ​ 587 Selling, general and administrative ​ 38,528 ​ 39,462 ​ (934) Change in fair value of contingent consideration ​ 13,741 ​ (13,216) ​ 26,957 Goodwill impairment ​ — ​ 40,659 ​ (40,659) Total operating expenses ​ 67,844 ​ 81,893 ​ (14,049) Loss from operations ​ (39,421) ​ (57,393) ​ 17,972 Other income, net: ​ ​ ​ ​ ​ ​ Interest income ​ ​ 4,136 ​ ​ 4,494 ​ ​ (358) Income from transition services agreement, net ​ 2,288 ​ — ​ 2,288 Other expense, net ​ ​ (346) ​ (241) ​ (105) Total other income, net ​ 6,078 ​ 4,253 ​ 1,825 Loss from continuing operations before income taxes ​ ​ (33,343) ​ ​ (53,140) ​ ​ 19,797 Income tax benefit ​ ​ 66 ​ ​ — ​ ​ 66 Net loss from continuing operations, net of income taxes ​ $ (33,277) ​ $ (53,140) ​ $ 19,863 ​ Revenue, Cost of revenue and Gross profit Product Our product revenue is comprised of revenue from sales of devices and related accessories, software and consumables and service as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Amount ​ ​ ​ % ​ ​ (dollars in thousands) Product revenue ​ $ 43,281 ​ $ 35,530 ​ $ 7,751 22 % Product cost of revenue ​ 22,325 ​ 17,387 ​ 4,938 28 % Gross profit ​ $ 20,956 ​ $ 18,143 ​ $ 2,813 16 % Gross profit margin ​ 48 % 51 % (3) % ​ ​ ​ Product revenue increased by $7.8 million, or 22%, for the year ended December 31, 2025, compared to the year ended December 31, 2024.
We regularly review inventory quantities on-hand for excess and obsolete inventory and, when circumstances indicate, record charges to write down inventories to their estimated net realizable value, after evaluating historical sales, future demand, market conditions and expected product life cycles. Such charges are classified as cost of revenue in the consolidated statements of operations and comprehensive loss.
We regularly review inventory quantities on-hand for excess and obsolete inventory and, when circumstances indicate, record charges to write down inventories to their estimated net realizable value, after evaluating historical sales, future demand, market conditions and expected product life cycles. Such charges are classified as cost of revenue in the consolidated statements of operations and comprehensive income (loss).
Our ability to successfully address the factors below is subject to various risks and uncertainties, including those described under the heading “ Risk Factors. ” Device sales Our financial performance has largely been driven by, and in the future will continue to be impacted by, the rate of sales of our handheld and desktop devices.
Our ability to successfully address the factors below is subject to various risks and uncertainties, including those described under the heading “ Risk Factors. ” Device sales Our financial performance has largely been driven by, and in the future will continue to be impacted by, the rate of sales of our handheld devices.
We expect to continue to incur net losses as we focus on growing commercial sales of our products in both the United States and international markets, including growing our sales teams, scaling our manufacturing operations, continuing research and development efforts to develop new products and further enhance our existing products.
We expect to continue to incur net losses as we focus on growing sales of our products in both the United States and international markets, including growing our sales teams, scaling our manufacturing operations, continuing research and development efforts to develop new products and further enhance our existing products.
Our future funding requirements will depend on many factors, including: ● market uptake of our products and growth into new and existing markets: ● the cost of our research and development efforts to expand the applications of our current devices and to create enhanced products with our platform of technologies; ● the cost of expanding our commercial operations, including distribution capabilities, and accelerating planned investments, such as hiring additional support, service, and sales management in Europe, Asia Pacific, and Latin America, bolstering our infrastructure in these regions; ● the cost of acquiring complementary businesses, products, services, or technologies, when and if required; ● the success of our existing collaborations and our ability to enter additional collaborations in the future; ● the effect of competing technological and market developments; and ● the level of our selling, general and administrative expenses.
Our future funding requirements will depend on many factors, including: ● market uptake of our products and growth into new and existing markets: ● the cost of our research and development efforts to expand the applications of our current devices and to create enhanced products with our platform of technologies; ● the cost of expanding our commercial operations, including distribution capabilities, and accelerating planned investments, such as hiring additional support, service, and sales management in Europe, Asia Pacific, and Latin America, bolstering our infrastructure in these regions; ● the cost of acquiring complementary businesses, products, services, or technologies, when and if required; 69 Table of Contents ● the success of our existing collaborations and our ability to enter additional collaborations in the future; ● the effect of competing technological and market developments; and ● the level of our selling, general and administrative expenses.
Our gross profit in future periods will vary based upon our channel mix and may decrease based upon our distribution channels and the potential to establish original equipment manufacturing channels for certain components of our technology platform which would have a lower gross margin. ​ We expect that our gross profit margin will increase over the long term as our sales and production volumes increase and our cost per unit decreases due to efficiencies of scale.
Our gross profit in future periods will vary based upon our channel mix and may decrease based upon our distribution channels and the potential to establish original equipment manufacturing channels for certain components of our technology platform which would have a lower gross margin. ​ We expect that our gross profit margin for product and service will increase over the long term as our sales and production volumes increase and our cost per unit decreases due to efficiencies of scale.
This may include an onsite or virtual demonstration with a salesperson, a customer submitting samples for testing in one of our facilities or testing by a third party. ● Trials—a customer has committed to a trial of one of our products, which may include a defined period to assess functionality of the device in their operational environment (in the field or onsite within the customer’s facility). ● Pilot—a customer commits to the purchase of an initial quantity of devices to deploy in their operational environment to assess a broader opportunity that may grow to tens or hundreds of devices. ● Deployment—a customer has completed testing, a trial, and/or a pilot and intends to roll out the technology across their enterprise (either at a site or throughout the entire organization).
This may include an onsite or virtual demonstration with a salesperson, a customer submitting samples for testing in one of our facilities or testing by a third party. ● Trials—a customer has committed to a trial of one of our products, which may include a defined period to assess functionality of the device in their operational environment (in the field or onsite within the customer’s facility). ● Pilot—a customer commits to the purchase of an initial quantity of devices to deploy in their operational environment to assess a broader opportunity that may grow to tens or hundreds of devices. 61 Table of Contents ● Deployment—a customer has completed testing, a trial, and/or a pilot and intends to roll out the technology across their enterprise (either at a site or throughout the entire organization).
Front-line workers rely upon our handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose. First responders also utilize our handheld devices to detect and identify thousands of hazardous bulk materials.
Front-line workers rely upon our Mass Spec handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose. First responders also utilize our handheld devices to detect and identify thousands of hazardous bulk materials.
Management focuses on device sales as an indicator of current business success and a leading indicator of likely future recurring revenue from consumables and services. We expect our device sales to continue to grow as we increase penetration in our existing markets and expand into, or offer new features and solutions that appeal to, new markets.
Management focuses on device sales as an indicator of current business success and a leading indicator of likely future recurring revenue from consumables , accessories, software and services. We expect our device sales to continue to grow as we increase penetration in our existing markets and expand into, or offer new features and solutions that appeal to, new markets.
Our contract agreements are with the U.S. government and commercial entities (who may be contracting with the government). Contracts typically include compensation for labor effort and materials incurred related to the deliverables under the contract. Our contract revenue was primarily related to one customer during the years ended December 31, 2024 and 2023.
Our contract agreements are with the U.S. government and commercial entities (who may be contracting with the government). Contracts typically include compensation for labor effort and materials incurred related to the deliverables under the contract. Our contract revenue was primarily related to one customer during the years ended December 31, 2025 and 2024.
For example, general inflation in the United States, Europe, the Middle East and other geographies has recently been at levels not experienced in recent decades, which has led to higher prices for our raw materials and other inputs, as well as higher salaries and travel expenses, which could continue to negatively impact our business by increasing our cost of sales and operating expenses.
For example, general inflation in the United States, Europe, the Middle East and other geographies has recently been at levels not experienced in recent decades, which has led to higher prices for our raw materials and other inputs, as well as higher salaries and travel expenses, which could continue to negatively impact our business by increasing our cost of sales and 59 Table of Contents operating expenses.
We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us. ​ Contract agreements are arrangements whereby we provide engineering services for the development of our technology platform for specific programs or new and expanding applications of our technologies for future commercial endeavors.
We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us. ​ 62 Table of Contents Contract revenue ​ Contract agreements are arrangements whereby we provide engineering services for the development of our technology platform for specific programs or new and expanding applications of our technologies for future commercial endeavors.
We estimate the fair value of the contingent consideration earnouts using the Monte Carlo Simulation or probability weighted scenario depending on the nature of the contingent consideration and update the fair value of the contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a discount rate that captures the risk associated with the expected contingent payments.
We estimate the fair value of the contingent consideration earnouts using the Monte Carlo Simulation or probability weighted scenario depending on the nature of the contingent consideration and update the fair value of the contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a 74 Table of Contents discount rate that captures the risk associated with the expected contingent payments.
Our gross profit in future periods will depend on a variety of factors, including: market conditions that may impact our pricing, sales mix among devices, sales mix changes among consumables, excess and obsolete inventories, our cost structure for manufacturing operations relative to volume, and product warranty obligations.
Our gross profit in future periods will depend on a variety of factors, including: market 63 Table of Contents conditions that may impact our pricing, sales mix among devices, sales mix changes among consumables, excess and obsolete inventories, our cost structure for manufacturing operations relative to volume, and product warranty obligations.
Business combination Under the acquisition method of accounting, we generally recognize the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition.
Business Combinations Under the acquisition method of accounting, we generally recognize the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition.
To the extent that these estimates change in the future regarding the likelihood of achieving these targets, we may need to record material adjustments to 82 Table of Contents our accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration expense or income in the consolidated statements of operations.
To the extent that these estimates change in the future regarding the likelihood of achieving these targets, we may need to record material adjustments to our accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration expense or income in the consolidated statements of operations.
The majority of our international sales are through contractual arrangements with channel partners. ​ Cost of Revenue, Gross Profit and Gross Margin Cost of product revenue primarily consists of costs for raw material parts and associated freight, shipping and handling costs, royalties, contract manufacturer costs, salaries and other personnel costs, overhead, amortization of intangibles and other direct costs related to those sales recognized as product revenue in the period. ​ Cost of service and contract revenue primarily consists of salaries and other personnel costs, travel related to services provided, facility costs associated with training, warranties and other costs of servicing equipment on a return-to-factory basis and at customer sites.
The majority of our international sales are through a distribution channel. ​ Cost of Revenue, Gross Profit and Gross Margin Product cost of revenue primarily consists of costs for raw material parts and associated freight, shipping and handling costs, royalties, contract manufacturer costs, salaries and other personnel costs, overhead, amortization of intangibles and other direct costs related to those sales recognized as product revenue in the period. ​ Cost of revenue for services primarily consists of salaries and other personnel costs, travel related to services provided, facility costs associated with training, warranties and other costs of servicing equipment on a return-to-factory basis and at customer sites.
Future device and consumable selling prices and gross margins may fluctuate due to a variety of factors, including the introduction by others of competing products and solutions.
Future device and recurring selling prices and gross margins may fluctuate due to a variety of factors, including the introduction by others of competing products and solutions.
Remeasurement of the contingent consideration obligation is done each quarter and the carrying value of the obligation is adjusted to the current fair value through our consolidated statements of operations. ​ Goodwill impairment ​ Goodwill impairment is the result of the fair value of our single reporting unit being less than its carrying value.
Remeasurement of the contingent consideration obligation is done each quarter and the carrying value of the obligation is adjusted to the current fair value through our consolidated statements of operations. ​ 64 Table of Contents Goodwill impairment ​ Goodwill impairment is the result of the fair value of our single reporting unit being less than its carrying value.
Our principal terms of sale are freight on board, or FOB, shipping point, or equivalent, and, as such, we primarily transfer control and record revenue for product sales upon shipment.
Our principal terms of sale are freight on board, or FOB, shipping point, or equivalent, and, as such, we primarily transfer control and record revenue for devices and consumables sales upon shipment.
The Amended 2022 Revolver also contains certain financial covenants, including a requirement that the Company maintain $20.0 million on account at or through the Lender and that the amount of unrestricted and unencumbered cash minus advances under the Amended 2022 Revolver, is not less than the amount equal to the greater of (i) $10.0 million or (ii) nine (9) months of cash burn.
The Amended 2022 Revolver also contains certain financial covenants, including requirements that the Company maintain $20.0 million on account at or through SVB and that the amount of unrestricted and unencumbered cash minus advances under the Amended 2022 Revolver is not less than the amount equal to the greater of (i) $10.0 million or (ii) nine (9) months of cash burn.
Although we do not directly source any material products or supplies from Russia, Ukraine, Israel, Lebanon or the Gaza Strip, our customers in Europe and the Middle East could be impacted by extended conflicts or an escalation of these conflicts into neighboring countries.
Although we do not directly source any material products or supplies from Russia , Ukraine or the Middle East , our customers in Europe and the Middle East could be impacted by extended conflicts or an escalation of these conflicts into neighboring countries.
Pursuant to the Amended 2022 Revolver, the Lender waived filing any legal action or instituting or enforcing any rights and remedies it may have had against the Company in connection with the Company’s failing to maintain all of its operating accounts, depository accounts and excess cash with the Lender, as previously required under the 2022 Revolver.
Pursuant to the Amended 2022 Revolver, SVB waived filing any legal action or instituting or enforcing any rights and remedies it may have had against the Company in connection with the Company’s failing to maintain all of its operating accounts, depository accounts and excess cash with SVB, as previously required prior to the effectiveness of the Amended 2022 Revolver.
Overview We have developed an innovative suite of purpose-built handheld and desktop devices for point-of-need chemical analysis. Leveraging complementary analytical technologies including our proprietary mass spectrometry, or Mass Spec, microfluidics, and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.
Overview We have developed an innovative suite of purpose-built handheld devices for point-of-need chemical analysis. Leveraging complementary analytical technologies including our proprietary mass spectrometry, or Mass Spec, and FTIR, an optical spectroscopy technology and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.
Investing Activities During the year ended December 31, 2024, net cash used in investing activities was $46.3 million, due to cash paid with the acquisition of RedWave of $44.8 million and $0.6 million in purchases of property and equipment.
In addition, we used $2.0 million for the acquisition of KAF. During the year ended December 31, 2024, net cash used in investing activities was $46.3 million, due to cash paid with the acquisition of RedWave of $44.8 million and $0.6 million in purchases of property and equipment.
Recurring revenue We regularly assess trends relating to recurring revenue which includes consumables and services based on our product offerings, our customer base and our understanding of how our customers use our products. Recurring revenue was 39% and 33% of total revenue for the years ended December 31, 2024 and 2023, respectively.
Recurring revenue We regularly assess trends relating to recurring revenue which includes consumables, accessories, software and services based on our product offerings, our customer base and our understanding of how our customers use our products. Recurring revenue was 35% and 33% of total revenue for the years ended December 31, 2025 and 2024, respectively.
Revenue is recognized when control of the promised products, consumables or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those products, consumables or 80 Table of Contents services (the transaction price).
Revenue is recognized when control of the promised devices, consumables or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those devices, consumables or services (the transaction price).
As of December 31, 2024, the Company also had U.S. federal and state research and development tax credit carryforwards of $8.6 million and $4.8 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2032 and 2030, respectively.
As of December 31, 2025, the Company also had U.S. federal and state research and development tax credit carryforwards of $9.1 million and $4.9 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2032 and 2030, respectively.
During the years ended December 31, 2024 and 2023, our product placements (units recognized as revenue) were as follows: ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 Product Placements: ​ ​ Handheld 593 402 Desktop 58 66 ​ The number of product placements vary considerably from period-to-period due to the type and size of our customers and concentrations among larger government customers as described above.
During the years ended December 31, 2025 and 2024, our product placements (units recognized as revenue) were as follows: ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2025 ​ ​ ​ 2024 Product Placements: ​ ​ ​ ​ Handheld ​ 721 ​ 593 ​ The number of product placements vary considerably from period-to-period due to the type and size of our customers and concentrations among larger government customers as described above.
Our recurring revenue as a percentage of total revenue will vary based upon new device placements in the period. As our device installed base expands, recurring revenue on an absolute basis is expected to increase and over time should be an increasingly important contributor to our revenue. Revenue from the sales of consumables will vary by type of device.
Our recurring revenue as a percentage of total revenue will vary based upon new device placements in the period. As our device installed base expands, recurring revenue on an absolute basis is expected to increase and over time should be an increasingly important contributor to our revenue. Recurring revenue is primarily from service revenue , software and accessories.
Allocation of the transaction price is determined at the contract’s inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. We derive revenue primarily from the sale of handheld and desktop products and related consumables and services.
Allocation of the transaction price is determined at the contract’s inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. 72 Table of Contents We derive revenue primarily from the sale of devices and related consumables and services.
We cannot accurately predict the full impact of current macroeconomic factors on the budgets and capital expenditures of our customers, or the timing of the normalization of customer purchasing patterns. We are closely monitoring the ongoing military conflict between Russia and Ukraine, and the ongoing hostilities in Israel, Lebanon, and the Gaza Strip and other locations in the Middle East.
We cannot accurately predict the full impact of current macroeconomic factors on the budgets and capital expenditures of our customers, or the timing of the normalization of customer purchasing patterns. We are closely monitoring the ongoing military conflict between Russia and Ukraine or the conflicts in the Middle East .
The total future minimum payments under such leases are $8.5 million as of December 31, 2024, of which $2.3 million is expected to be paid in 2025. At times, we have purchase orders or contracts for the purchase of supplies and other goods and services.
The total future minimum payments under such leases are $6.0 million as of December 31, 2025, of which $1.1 million is expected to be paid in 2026. At times, we have purchase orders or contracts for the purchase of supplies and other goods and services.
Product gross profit increased by $0.5 million, or 2%, and gross profit margin decreased by 3% for the year ended December 31, 2024, as compared to the year ended December 31, 2023.
Product gross profit increased by $2.8 million, or 16%, and gross profit margin decreased by 3% for the year ended December 31, 2025, as compared to the year ended December 31, 2024.
Any debt or equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us.
If we raise additional funds through collaboration and 70 Table of Contents licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us.
As of December 31, 2024, we had cash and cash equivalents of $44.0 million and marketable securities of $25.6 million, which were held for working capital purposes and for investment in growth opportunities. Our marketable securities consist of U.S. treasury securities.
As of December 31, 2025, we had cash and cash equivalents of $70.5 million and marketable securities of $42.5 million, which were held for working capital purposes and for investment in growth opportunities. Our marketable securities consist of U.S. treasury securities.
The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements.
Critical Accounting Policies and Significant Judgments and Estimates Our consolidated financial statements are prepared in accordance with GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements.
As of December 31, 2024, the Company had gross federal and state operating loss carryforwards of $127.9 million and $92.5 million, respectively, which may be available to offset future taxable income and begin to expire in 2032 and 2025, respectively, of which $93.5 million of federal gross operating losses do not expire.
As of December 31, 2025, the Company had gross federal and state operating loss carryforwards of $147.0 million and $94.5 million, respectively. The federal operating loss carryforward may be available to offset future taxable income and begin to expire in 2032, of which $112.6 million of federal gross operating losses do not expire.
Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur. 81 Table of Contents The Black-Scholes option-pricing model uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our common stock options, the risk-free interest rate for a period that approximates the expected term of our common stock options, and our expected dividend yield.
The Black-Scholes option-pricing model uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our common stock options, the risk-free interest rate for a period that approximates the expected term of our common stock options, and our expected dividend yield.
While we expect the mix of direct sales as compared to sales through channel partners to remain relatively constant in the near term, we are currently evaluating increasing our direct sales capabilities in certain geographies.
While we expect the mix of direct sales as compared to sales through channel partners to remain relatively constant in the near term, we may consider increasing our direct sales capabilities in certain geographies based upon identified opportunities.
We were permitted to make interest-only payments on the revolving line of credit through November 2, 2025, at which time all outstanding indebtedness would be immediately due and payable.
The Company is permitted to make interest-only payments on the revolving line of credit through April 2, 2026, at which time all outstanding indebtedness shall be immediately due and payable.
Our obligations under the 2022 Revolver were secured by substantially all of our assets, excluding our intellectual property, which was subject to a negative pledge.
The Company’s obligations under the Amended 2022 Revolver are secured by substantially all of the Company’s assets, excluding its intellectual property, which is subject to a negative pledge.
We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing, which we believe will reduce costs and increase our gross margin. ​ Operating Expenses Research and development expenses Research and development expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering and consultant services and other costs associated with our technology platform and products, which include: ● employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and hardware and software development functions; ● the cost of maintaining and improving our product designs, including third party development costs for new products and materials for prototypes; ● research materials and supplies; and 71 Table of Contents ● facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance.
We expect that our gross profit margin for contract will remain consistent for our contracts that are cost reimbursement contracts. ​ Operating Expenses Research and development expenses Research and development expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering and consultant services and other costs associated with our technology platform and products, which include: ● employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and hardware and software development functions; ● the cost of maintaining and improving our product designs, including third party development costs for new products and materials for prototypes; ● research materials and supplies; and ● facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance.
The increase in product cost of revenue was primarily related to a $2.3 million increase in production costs related to the higher product revenues, $1.7 million in higher intangible amortization and $1.1 million in higher personnel related costs, partly related to our RedWave acquisition.
The increase in product cost of revenue was primarily related to an increase in production costs related to the higher product revenues, $2.3 million in higher personnel related costs, partly related to our RedWave and KAF acquisitions, $0.8 million in higher intangible amortization, and $0.3 million related to severance and retention costs.
Since our inception, we have incurred significant operating losses. Our ability to generate revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products.
The Company recognized a gain on the sale of the Desktop Portfolio upon closing. 58 Table of Contents Since our inception, we have incurred significant operating losses. Our ability to generate revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products.
We plan to grow our device sales in the coming years through multiple strategies including expanding our sales efforts domestically and globally and continuing to enhance the underlying technology and applications for bioprocessing and life sciences research related to our Maverick, Rebel, ZipChip Interface, and Maven and related sampling devices.
We plan to grow our device sales in the coming years through multiple strategies including expanding our sales efforts domestically and globally and continuing to enhance the underlying technology and applications for our handheld devices.
During the year ended December 31, 2023, net cash used in operating activities was $25.1 million, primarily resulting from our net loss of $36.4 million and net cash used in changes in our operating assets and liabilities of $1.6 million, partially offset by noncash charges of $12.9 million.
During the year ended December 31, 2024, net cash used in operating activities was $30.2 million, primarily resulting from our net loss of $72.2 million and net cash used in changes in our operating assets and liabilities of $2.5 million, partially offset by noncash charges of $44.5 million.
Cost of contract revenue primarily consists of salaries and other personnel costs, materials, travel and other direct costs related to the contract revenue recognized in the period. ​ Gross profit is calculated as revenue less cost of revenue. Gross profit margin is gross profit expressed as a percentage of revenue.
Contract cost of revenue primarily consists of salaries and other personnel costs, materials, travel and other direct costs related to the revenue recognized in the period.
While we sell single-use swab samplers for MX908 to be used in liquid and solid materials analysis, there are a number of other applications that the MX908 can be used for that do not require consumables. ThreatID, ProtectIR, and XplorIR do not have consumables. Rebel and ZipChip Interface require consumables kits for all areas of operations.
Consumable revenue is mainly related to single-use swab samplers for MX908 to be used in liquid and solid materials analysis, but there are a number of other applications that the MX908 can be used for that do not require consumables. ThreatID, ProtectIR, XplorIR and VipIR do not have consumables.
If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products.
If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products. We also may have to reduce marketing, customer support or other resources devoted to our products or cease operations.
We may seek additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, channel partner or licensing arrangements. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution.
We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution.
Our cumulative product placements consist of the following number of devices: ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2024 2023 Cumulative Product Placements: ​ ​ Handheld 3,015 2,422 Desktop 489 431 ​ 69 Table of Contents Components of Our Results of Operations Revenue We generate product and service revenue from the sale of our devices and recurring revenue from the sale of consumables and contract revenue.
Our cumulative product placements consist of the following number of devices: ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 Cumulative Product Placements: ​ ​ ​ ​ Handheld 3,736 3,015 ​ Components of Our Results of Operations Revenue Product and Service Revenue We generate product and service revenue from the sale of our devices and recurring revenue from the sale of consumables, accessories, software and services.
Financing Activities Cash used in financing activities during the year ended December 31, 2024, was $0.4 million, due primarily to a $0.5 million payment for contingent consideration earned with our acquisition of Trace Analytics GmbH.
Financing Activities 71 Table of Contents Cash used in financing activities during the year ended December 31, 2025, was $0.7 million, due primarily to a $0.7 million payment for contingent consideration achieved with our acquisition of KAF.
Device orders from a 67 Table of Contents government customer are typically large orders and can be impacted by the timing of their capital budgets. As a result, the revenue for our handheld devices can vary significantly from period-to-period and has been and may continue to be concentrated in a small number of customers in any given period.
As a result, the revenue for our handheld devices can vary significantly from period-to-period and has been and may continue to be concentrated in a small number of customers in any given period.
Service and contract gross profit increased by 114%, and gross profit margin increased by thirteen percentage points for the year ended December 31, 2024, as compared to the year ended December 31, 2023, primarily due to an increase in service volume related to extended service contracts and training revenue, leveraging our investments in personal and service infrastructure. ​ Operating Expenses Research and development ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ 2024 2023 Amount % ​ ​ (dollars in thousands) Research and development expenses ​ $ 25,495 ​ $ 21,904 ​ $ 3,591 16 % Percentage of total revenue ​ 43 % 44 % ​ ​ Our research and development expenses were $25.5 million for the year ended December 31, 2024, an increase of $3.6 million from research and development expenses of $21.9 million for the year ended December 31, 2023.
Service and contract gross profit increased by 17%, and gross profit margin increased by six percentage points for the year ended December 31, 2025, as compared to the year ended December 31, 2024, primarily due to an increase in service volume related to training and extended service contracts, leveraging our investments in personal and service infrastructure. 67 Table of Contents Operating Expenses Research and development ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Amount ​ ​ ​ % ​ ​ (dollars in thousands) Research and development expenses ​ $ 15,575 ​ $ 14,988 ​ $ 587 4 % Percentage of total revenue ​ 28 % 31 % ​ ​ ​ ​ Our research and development expenses were $15.6 million for the year ended December 31, 2025, an increase of $0.6 million from research and development expenses of $15.0 million for the year ended December 31, 2024.
To date, we have funded our operations primarily with proceeds from sales of redeemable preferred stock, borrowings under loan agreements and revenue from sales of our products and services and license and contract revenue, proceeds from our IPO in December 2020, and our underwritten public offering in November 2021.
To date, we have funded our operations primarily with proceeds from sales of equity, borrowings under loan agreements and revenue from sales of our products and services and license and contract revenue.
The straight-line method of expense recognition is applied to all awards with service-only conditions, while the graded vesting method is applied to all grants with both service and performance conditions.
The straight-line method of expense recognition is applied to all awards with service-only conditions, while the 73 Table of Contents graded vesting method is applied to all grants with both service and performance conditions. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur.
The outstanding principal amount of any advance accrued interest at a floating rate per annum equal to the greater of (i) three and one-half percent (3.50%) and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period minus one-half percent (0.50%).
The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) six percent (6.00%) or (ii) the “prime rate” as published in The Wall Street Journal.
Device sales accounted for 61% and 67% of our total revenue for the years ended December 31, 2024 and 2023, respectively. Consumables and contract revenue accounted for 39% and 33% of our total revenue for the years ended December 31, 2024 and 2023, respectively.
Device sales accounted for 65% and 66% of our total revenue for the years ended December 31, 2025 and 2024, respectively. Recurring revenue accounted for 35% and 33% of our total revenue for the years ended December 31, 2025 and 2024, respectively.
In addition, our selling price and, consequently, our margins, are higher for those devices and consumables that we sell directly to customers as compared to those that we sell through channel partners.
However, the percentage will be subject to fluctuation based upon our handheld sales in a period. In addition, our selling price and, consequently, our margins, are higher for those devices and recurring revenue that we sell directly to customers as compared to those that we sell through channel partners.
The Amended 2022 Revolver provides for a revolving line of credit of up to $10.0 million. The Company is permitted to make interest-only payments on the revolving line of credit through November 3, 2025, at which time all outstanding indebtedness shall be immediately due and payable.
The Amended 2026 Revolver supersedes and replaces the Amended 2022 Revolver and its extension upon the execution of the Amended 2026 Revolver. The Company is permitted to make interest-only payments on the revolving line of credit through March 5, 2028, at which time all outstanding indebtedness shall be immediately due and payable.
Challenging capital market conditions and the limited availability of financing alternatives, together with inflationary and interest rates pressures, may contribute to more cautious spending by our customers.
General inflation could also negatively impact our business if it leads to spending pressure and decreased available capital for our customers to deploy to purchase our products and services. Challenging capital market conditions and the limited availability of financing alternatives, together with inflationary and interest rates pressures, may contribute to more cautious spending by our customers.
This increase was offset in part by a $3.2 million decrease in MX908 related handheld product revenue, mainly due to fewer device placements, a $1.8 million decrease from component shipments under our subcontract agreement with a commercial entity that holds a U.S. government prime contract, as well as a $0.9 million decrease in desktop product revenue, mainly due to the mix of devices and three fewer desktop device placements, for the year ended December 31, 2024. ​ Product cost of revenue increased by $3.2 million, or 17%, for the year ended December 31, 2024, compared to the year ended December 31, 2023.
This increase was offset in part by a $2.1 million decrease in MX908 related handheld product revenue, mainly due to fewer device placements, and a $1.5 million decrease in 66 Table of Contents program product revenue related to our AVCAD program, pursuant to which we had component shipments under our subcontract agreement with a commercial entity for the year ended December 31, 2025. ​ Product cost of revenue increased by $4.9 million, or 28%, for the year ended December 31, 2025, compared to the year ended December 31, 2024.
We aim to mitigate downward pressure on our average selling prices by increasing the value proposition offered by our devices and consumables, primarily by expanding the applications for our devices and increasing the quantity and quality of data that can be obtained using our consumables. 68 Table of Contents Product adoption We monitor our customers’ stage of adoption of our products to provide insight into the timing of future potential sales and to help us formulate financial projections.
We aim to mitigate downward pressure on our average selling prices by increasing the value proposition offered by our devices , consumables , accessories and software , primarily by expanding the applications for our devices and increasing the quantity and quality of data that can be obtained using our consumables.
The purchase price included an initial payment of $45.0 million in cash and 1,497,171 unregistered shares of the Company’s common stock, which reflects closing adjustments relating to working capital, cash and debt adjustments. The cash consideration is subject to additional working capital, cash, debt, and transaction expense adjustments.
The purchase price included an initial payment of $45.0 million in cash and 1,497,171 unregistered shares of the Company’s common stock, which reflects closing adjustments relating to working capital, cash and debt adjustments. RedWave is a leading provider of portable Fourier Transform Infrared, or FTIR, spectroscopic analyzers for rapid chemical identification of bulk materials.
Provision for Income Taxes We have not recorded any U.S. federal or state income tax benefits for the net operating losses we have incurred in each year or for the research and development tax credits we generated in the United States and have recorded a full valuation allowance against our net deferred assets, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. 72 Table of Contents We recognized an income tax benefit of $0.3 million and $0.2 million during the years ended December 31, 2024 and 2023, respectively.
The Company is continuing to provide certain general and administrative functions under the TSA. ​ Other income (expense), net Other income (expense), net consists of miscellaneous other income and expense unrelated to our core operations, interest expense associated with the amortization of deferred financing costs and debt discounts associated with our loan and security agreements. ​ Provision for Income Taxes We have not recorded any U.S. federal or state income tax benefits for the net operating losses we have incurred in each year or for the research and development tax credits we generated in the United States and have recorded a full valuation allowance against our net deferred assets, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized.
Typical stages of adoption include testing, trials, pilot and deployment as follows: ● Testing—a customer is actively engaged with internal or external testing of our products.
Product adoption We monitor our customers’ stage of adoption of our products to provide insight into the timing of future potential sales and to help us formulate financial projections. Typical stages of adoption include testing, trials, pilot and deployment as follows: ● Testing—a customer is actively engaged with internal or external testing of our products.
The decrease was due to the lower cash, cash equivalent and marketable securities balance, primarily due to the average balance during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the use of cash with the RedWave acquisition. ​ Interest expense Interest expense decreased by $0.2 million for the year ended December 31, 2024 from $0.2 million for the year ended December 31, 2023.
The decrease was due to the lower cash, cash equivalent and marketable securities balances, primarily due to the average balance during the year ended December 31, 2025, compared to the year ended December 31, 2024 and, to a lesser extent, lower interest rates. ​ Income from transition services agreement, net Income from the transition services agreement, net was $2.3 million for the year ended December 31, 2025.
For the year ended December 31, 2023, a charge of $0.1 million was recorded to increase the value of the contingent consideration liability related to the Trace acquisition. ​ Goodwill impairment ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ 2024 2023 Amount % ​ ​ (dollars in thousands) Goodwill impairment ​ $ 40,659 ​ $ — ​ $ 40,659 NM ​ Percentage of total revenue ​ 68 % 0 % ​ ​ As a result of sustained decreases in our publicly quoted share price and market capitalization, a $40.7 million goodwill impairment was recorded for the year ended December 31, 2024. ​ Other Income (Expense) Interest income ​ Interest income decreased by $2.0 million for the year ended December 31, 2024 from $6.5 million for the year ended December 31, 2023.
The decline in the key assumptions of stock price and forecast from the RedWave acquisition date to December 31 2024, resulted in a reduction, or credit, of $13.2 million for the year ended December 31, 2024, reducing the contingent liability during that period. ​ 68 Table of Contents Goodwill impairment ​ As a result of sustained decreases in our publicly quoted share price and market capitalization, a $40.7 million goodwill impairment was recorded for the year ended December 31, 2024. ​ Other Income (Expense) Interest income ​ Interest income decreased by $0.4 million for the year ended December 31, 2025 from $4.5 million for the year ended December 31, 2024.
During the year ended December 31, 2023, net cash used in investing activities was $26.4 million, due to $48.9 million in purchases of marketable securities, partially offset by $24.5 million in proceeds from maturities of marketable securities and $2.0 million in purchases of property and equipment.
Investing Activities During the year ended December 31, 2025, net cash provided by investing activities was $50.7 million, due primarily to $69.9 million of proceeds from the sale of the Desktop Portfolio and $47.8 million of proceeds from the maturity of marketable securities, partially offset by $64.0 million in purchases of marketable securities.
The income tax benefit recognized during the year ended December 31, 2024 primarily resulted from a reduction in the deferred tax liabilities recorded as part of our acquisition of 908 Devices GmbH.
We recognized an income tax benefit of $0.1 million and no income tax benefit during the years ended December 31, 2025 and 2024, respectively. The income tax benefit recognized during the year ended December 31, 2025 primarily resulted from a foreign tax refunds received as part of our divesture of 908 Devices GmbH.
Over time, as our device installed base grows and we see adoption of Rebel, we expect consumables revenue to constitute a larger percentage of total revenue. However, the percentage will be subject to fluctuation based upon our handheld sales in a period.
Revenue mix and gross margin Our revenue is derived from sales of our devices, consumables, accessories, software and services. There will be fluctuations in the mix between devices and recurring from period-to-period. Over time, as our device installed base grows, we expect service revenue to constitute a larger percentage of total revenue.
We believe the insights and answers our devices provide accelerate workflows, reduce costs, and offer transformational opportunities for our end users. The term “products” as used in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” refers to the MX908, ThreatID, ProtectIR, XplorIR, Rebel, ZipChip Interface, Maverick, Maven and related sampling devices.
The term “products” as used in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” refers to the MX908, ThreatID, ProtectIR, XplorIR, VipIR and related devices.
Each chip is used for a defined number of samples (or runs). We recognize revenue from the sale of consumables as the consumable products are shipped. We also offer our customers extended warranty and service plans. Our extended warranty and service plans are offered for periods beyond the standard one-year warranty that all of our customers receive.
Our consumables consist primarily of accessories and swabs for MX908. ​ We also offer our customers extended warranty and service plans. Our extended warranty and service plans are offered for periods beyond the standard one-year warranty that all of our customers receive.
We generated revenue of $59.6 million and $50.2 million for the years ended December 31, 2024 and 2023, respectively, 65 Table of Contents and incurred net losses of $72.2 million and $36.4 million for those same years. As of December 31, 2024, we had an accumulated deficit of $242.8 million.
We generated revenue of $56.2 million and $47.7 million for the years ended December 31, 2025 and 2024, respectively, and incurred net losses from continuing operations of $33.3 million and $53.1 million for those same years. As of December 31, 2025, we had an accumulated deficit of $223.3 million.
The goodwill impairments in 2024 resulted from sustained decreases in our publicly quoted share price and market capitalization and as of December 31, 2024 our goodwill was reduced to zero. ​ Other Income (Expense) Interest income Interest income consists of interest earned on our invested cash balances. ​ Interest expense ​ Interest expense consists of interest expense associated with outstanding borrowings under our loan and security agreements and the amortization of deferred financing costs and debt discounts associated with such arrangements.
The goodwill impairments in 2024 resulted from sustained decreases in our publicly quoted share price and market capitalization and as of December 31, 2024 our goodwill was reduced to zero. ​ Other Income (Expense) Interest income Interest income consists of interest earned on our invested cash, cash equivalents and marketable securities balances. ​ Income from Transition Services Agreement, net Income from transition services agreement, net represents service charges provided to Repligen to facilitate the transition of the Desktop Portfolio, net of directly identifiable personnel related costs, pursuant to the TSA.
Cash used in financing activities during the year ended December 31, 2023, was $15.9 million, consisting primarily of the repayment of $15.0 million outstanding under the 2022 Revolver and $1.1 million in payments for contingent consideration related to the release of the $0.9 million assignment of the pension liability in connection with our acquisition of Trace Analytics GmbH and the $0.2 million initial fair value of contingent consideration, related to the $0.5 million initial milestone achievement in August 2023, that was paid in 2023. 79 Table of Contents Contractual Obligations We have operating lease obligations for office space and certain equipment, which have remaining lease terms ranging from less than one year to nine years.
Cash used in financing activities during the year ended December 31, 2024, was $0.4 million, due primarily to a $0.5 million payment for contingent consideration achieved with our acquisition of Trace Analytics GmbH. Contractual Obligations We have operating lease obligations for office space, which have remaining lease terms ranging from two years to nine years.
The increase was mainly due to the increased expenses from the RedWave acquisition and was due primarily to a $2.0 million increase in personnel and related costs, a $0.8 million increase in stock-based compensation, a $0.5 million increase in project spend related to materials and consulting, and a $0.2 million increase in depreciation and occupancy related expenses, mainly related to our facilities in Connecticut and North Carolina. ​ Selling, general and administrative expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ 2024 2023 Amount % ​ ​ (dollars in thousands) Selling, general and administrative expenses ​ $ 53,636 ​ $ 46,069 ​ $ 7,567 16 % Percentage of total revenue ​ 90 % 92 % ​ ​ Our selling, general and administrative expenses were $53.6 million for the year ended December 31, 2024, an increase of $7.6 million from selling, general and administrative expenses of $46.1 million for the year ended December 31, 2023.
The increase was partly due to the increased expenses from the RedWave acquisition and was due primarily to a $0.5 million increase in project expenditure related to materials and consulting and a $0.4 million increase in severance and retention costs, offset in part by a $0.2 million decrease in facility related costs and a $0.2 million decrease in depreciation. ​ Selling, general and administrative expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Amount ​ ​ ​ % ​ ​ (dollars in thousands) Selling, general and administrative expenses ​ $ 38,528 ​ $ 39,462 ​ $ (934) (2) % Percentage of total revenue ​ 69 % 83 % ​ ​ ​ ​ Our selling, general and administrative expenses were $38.5 million for the year ended December 31, 2025, a decrease of $0.9 million from selling, general and administrative expenses of $39.5 million for the year ended December 31, 2024.
This acquisition provides us with an expanded portfolio of handheld chemical analysis devices for forensic workflows that quickly detect and identify unknown solids, liquids, vapors, and aerosols at the point of need. In addition, RedWave bolsters our desktop portfolio with a line of accessories for pharma Process Analytical Technology, or PAT, and industrial Quality Control applications.
FTIR, an optical spectroscopy technology, is highly regarded for its specific substance identification abilities across a broad range of bulk materials. This acquisition provides us with an expanded portfolio of handheld chemical analysis devices for forensic workflows that quickly detect and identify unknown solids, liquids, vapors, and aerosols at the point of need.
We also may have to reduce marketing, customer support or other resources devoted to our products or cease operations. 78 Table of Contents Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ ​ (in thousands) Cash used in operating activities ​ $ (30,247) ​ $ (25,059) Cash used in investing activities ​ (46,321) ​ (26,400) Cash used in financing activities ​ (376) ​ (15,935) Effect of foreign exchange rate changes on cash and cash equivalents ​ ​ (65) ​ ​ 13 Net decrease in cash, cash equivalents and restricted cash ​ $ (77,009) ​ $ (67,381) ​ Operating Activities During the year ended December 31, 2024, net cash used in operating activities was $30.2 million, primarily resulting from our net loss of $72.2 million and net cash used in changes in our operating assets and liabilities of $2.5 million, partially offset by noncash charges of $44.5 million.
Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (in thousands) Cash used in operating activities ​ $ (23,688) ​ $ (30,247) Cash provided by (used in) investing activities ​ 50,747 ​ (46,321) Cash used in financing activities ​ (697) ​ (376) Effect of foreign exchange rate changes on cash and cash equivalents ​ ​ 27 ​ ​ (65) Net increase (decrease) in cash, cash equivalents and restricted cash ​ $ 26,389 ​ $ (77,009) ​ Operating Activities During the year ended December 31, 2025, net cash used in operating activities was $23.7 million, consisting primarily of a $55.9 million gain on sale of our Desktop Portfolio, net of transaction costs, and net cash used in changes in our operating assets and liabilities of $15.3 million, partially offset by our net income of $19.5 million and noncash uses of $27.9 million, inclusive of a noncash use of $13.7 million related to the change in fair value of contingent consideration increase.

… 64 more changes not shown on this page.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed0 unchanged
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item. ​ ​ 83 Table of Contents ​
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item. ​ ​ 75 Table of Contents ​ ​

Other MASS 10-K year-over-year comparisons