908 Devices Inc.

Good day and thank you for standing by. Welcome to the 908 Devices 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Kelly Gura, Investor Relations. Please go ahead.

Thank you. This morning, 908 Devices released financial results for the quarter ended September 30th, 2021. If you've not received this news release, or if you'd like to be added to the company's distribution list, please send an email to ir at 908devices.com. Joining me today from 908 is Kevin Knopp, Chief Executive Officer and Co-Founder, and Joe Griffith, Chief Financial Officer. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the press release 908 issue today. For a more complete list and description, please see the Risk Factors section of the company's annual report on Form 10-K for the year ended December 31, 2020, and in its other filings with the Securities and Exchange Commission. Except as required by law, 908 disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast, November 4, 2021. With that, I would like to turn the call over to Kevin.

Thanks, Kelly. Good morning, and thank you for joining our third quarter 2021 earnings call. We are continuing to make excellent progress, broadening our global presence, strengthening our relationships, and expanding our offering to deliver even more value to our customers. We ended the third quarter with $12.5 million in total revenue, up 52% from the second quarter of 2021, and up 107% year over year. I'm pleased with our performance, which was in line with our expectations that our revenue would step up in the back half of the year as we continue to ramp our commercial efforts and benefit from seasonal year-end budget cycles. We placed more than 180 devices during the quarter, bringing our installed base to over 1,700 devices across our three products. We have made meaningful progress scaling our commercial team, demonstrating traction within our growing customer base, and highlighting the needs for our technology within our core forensics, research, and biopharma applications. As we think about our growth, we remain focused on expanding the install base, driving utilization, and investing in our technology platform. Starting with our sales channels and commercial organization, we ended the third quarter with 57 employees across sales, marketing, and product management. I'm excited by the talent we continue to bring to the 908 team, and we are well on our way to reaching our goal of 60 commercial employees by the end of Q1 2022. We are ramping our efforts in engaging existing, new, and prospective customers on the value of our technologies. To that end, in September, we hosted our first integrated user meeting, Critical Mass 2021, which covered the full breadth of our product platforms and their applications. This event brought more than 150 attendees together, both virtually and in person, to hear our customers share their success using our handheld and desktop devices to democratize access to mass spectrometry. These customers' talks span the breadth of our customer base, from pharma with Amgen, Merck, AstraZeneca, and Sartorius, to top research institutions with Johns Hopkins University and Dana-Farber Cancer Institute, to government agencies with the USDA, Maine Drug Enforcement Agency, and the Quincy Police Department. Tony Zuck, the Executive Director of Product Integrity at Merck, was a keynote speaker for the event and discussed the critical role forensic testing plays in criminal enforcement against counterfeit drugs. It was inspiring to hear the impact our technology is having across a range of topics, from bioprocess monitoring to identification of counterfeit pharmaceuticals to high-throughput drug discovery. And perhaps even most importantly, the event gave our customers the opportunity to engage in discussions together not only to share their experiences, but also to increase awareness and educate each other on the value of our technology across these different applications areas. As we ramp our commercial efforts, we are seeing growing customer traction. Across our product portfolio, we focus on leveraging our customer success in testing, trials, and pilots into enterprise-wide standardization for both devices and consumables. With our handhelds, we continue to gain traction with leading government enterprise accounts for using MX908 for trace detection and identification of narcotics and other chemical hazards. For example, the Department of Homeland Security purchased additional MX908 devices to combat the flow of illicit drugs, including opioids, from entering our borders. The U.S. Drug Enforcement Administration also added MX908 devices for their clandestine drug lab enforcement teams. In addition to growing our existing enterprise accounts, we are continuing to build a pipeline of pilot programs that have the potential to evolve into valuable enterprise accounts. In October, Ohio Attorney General David Yost announced a pilot program for police departments in three cities where law enforcement officers will use our MX-908 handheld devices for rapid mobile drug testing. In the press conference, A.G. Yost noted that the MX-908 is literally a crime lab in your hands. We currently have over 20 MX-908s in use in the state of Ohio, and the Ohio Attorney General has expressed desire for every police department in the state to eventually have an MX-908 device. We are proud of the value that MX-908 is bringing these law enforcement programs and the communities they serve and are committed to bringing similar value to additional agencies across the United States. Unfortunately, overdose deaths involving lethal drugs like fentanyl and methamphetamine are on the rise. At the end of September, the Drug Enforcement Administration issued a public safety alert warning Americans of the sharp increase in fake prescription pills containing fentanyl and methamphetamine. This was the first advisory the DEA has issued in six years. According to the advisory, the number of DEA-seized counterfeit pills with fentanyl has jumped a staggering amount by nearly 430% since 2019. Today, two out of every five pills with fentanyl contain a potential lethal dose. And according to a recent study by the National Institute of Drug Abuse, overdose deaths in the U.S. involving methamphetamine nearly tripled from 2015 to 2019 among people aged 18 to 64. Even a small amount of these drugs can be lethal. Our MX908 handheld device detects trace levels of a full panel of drugs in seconds, minimizing exposure for first responders and enabling personnel to immediately act. Our handhelds are a game changer for the opioid crisis with the ability to detect and identify trace amounts of drugs. I would like to take a minute to share a few examples of recent customer successes using our handheld devices that underscore the growing need for this technology. At Mexico International's airport, customs personnel recently used the MX-908 to detect pounds of hidden cocaine wrapped in two vests, enabling officials to immediately seize the drugs. Lab tests later confirmed the accuracy of the MX-908 analysis. In another instance, during an examination of a stolen vehicle, technicians from the Canadian Decontamination Solutions observed a white powder in the glove compartment box, suspecting an airborne hazard The team used the newly released Aero module for the MX-908 to confirm the presence of airborne fentanyl, which is highly toxic. The MX provided critical information to keep technicians safe over the course of the vehicle inspection. Our handheld devices provide analysis for applications across chemical and narcotic detection. We are demonstrating solid traction with customers who rely on our technology to combat critical-to-life problems with easily interpretable, actionable results in seconds. Turning now to our desktops, today we are focused on placing our devices with top pharma companies where there's ample room to increase adoption within a single customer account. We saw strong traction during the quarter with new placements increasing by more than 40% compared to the same period last year. This growth was primarily driven by traction in our core biopharma segment with new desktop customers including Gilead Sciences, Boinger Ingelheim, and Janssen Pharmaceuticals. We have placed devices with 19 of the top 20 pharma companies. Our Rebel product offers critical value to customers, providing process insights and a new lens into the bioprocess workflow that allows for real-time process optimization. Recently, at the Bioprocessing Summit in Boston, an Alexion pharmaceutical scientist presented results where our desktop device was used to mitigate amino acid misincorporation and optimize feeding strategies for a production bioreactor to rapidly achieve the desired critical quality attributes, also known as CQAs. We've previously shared our plan to create a bioanalytic platform that leverages our versatile technologies from biotherapeutic development through production. The need for such a platform is validated by FDA's widely publicized Quality by Design Initiative, which stresses the importance of understanding, monitoring, and controlling of process parameters to ensure finished biopharmaceuticals products meet proper CQAs. The pharmaceutical industry also broadly recognized that enhanced process understanding and control leads to improved yield and predictability, particularly important with newer therapeutic modalities. Our devices are directly positioned to serve these needs. And finally, moving to innovation related to our products and technology platform, We are working to expand the capabilities of our existing products as well as expand the reach of our technology platform. For our handhelds, we released a software update to our field base of MX908s that adds nine new analyte targets for a total of 19 new targets added so far this year. These new analyte targets are mainly synthetic drug compounds such as cannabinoids, cathinones, and opioids. This builds on the already significant capability of the MX908, ensuring the latest technologies in the hands of safety and health responders across the globe. For our ZIP chip, we recently launched an oligonucleotide analysis kit. Oligos represent a distinct class of therapeutics that include RNA, DNA, and their structural analogs, and are effective against a wide range of disease conditions. Traditional workflows for oligoanalysis are lengthy, often requiring the use of extensive liquid chromatography method development, along with harsh ion-pairing reagents. Our ZipChip device, coupled with the mass spectrometer, provides an easy method for simple and fast analysis of oligos with minimal sample prep and no need for iron-pairing reagents. At the American Society for Mass Spectrometry Meeting, or ASMS, we presented a talk in conjunction with Amgen that demonstrated the use of our ZipChip kit on proprietary Amgen oligos, resulting in decreased analysis time and sample requirements without the use of iron-pairing reagents. We are excited to provide our users with a simple, rapid, and cost-effective solution for oligo analysis, enabling them to accelerate their drug development workflow. We are continuing to unlock our platform's capabilities to increase the areas of use for our customers and open up our addressable markets. For our desktops, we are also continuing our effort to expand downstream into late-stage development and finished product quality domains. In May of this year, we announced a joint collaboration with Biotechni to develop an extended CQA workflow solution for protein characterization. The pairing of Biotechni CIEF systems and Zipchip allows for in-depth characterization of biotherapeutics on an intact and near-native level with a vastly simplified and time-saving workflow. As an update, in September, we presented with Biotechni at the CAS Mass Spec Conference to demonstrate this workflow solution. This need for rapid high-resolution identification and speciation of intact proteoforms was also highlighted by Boringer-Ingelheim at the subsequent CAST-CE Pharma Conference, where they spoke to the rapid characterization of a bispecific antibody using our ZipChip device and noted the quality of the separations and ease of setup. We are encouraged by this work and our demonstrations to the community. While we are largely focused on bioanalytics as the primary application for our desktops, there is a breadth of opportunity for our products and technologies beyond bioanalytics, including in proteomics and metabolomics. Just this week at ASNS, there were a number of presentations on the application of our products and technologies. Presentations were from our own scientists, as well as researchers from Amgen, Ligon Pharmaceuticals, and Dana-Farber Cancer Institute. Three of these presentations were in the areas of proteomics and metabolomics. First, we presented clinical metabolomic studies that compared our Zipchip hardware and associated 908 devices' automated metabolite identification algorithms to legacy technology. The Zipchip approach demonstrated tremendous speed advantages with much higher rates of metabolite IDs and few false IDs. And as we have shared, we're developing new microfluidic chips for our platform for proteomic applications. Two presentations at ASMS highlighted the increased sensitivity and speed of these prototype chips. Our own scientists presented a poster that demonstrated a greater than tenfold improvement in sensitivity for proteomics applications when integrating solid-phase extraction, or SPE, onto the chip. Integrated SPE allows us to capture and measure low-abundance proteins. Scientists at the Dana-Farber Cancer Institute evaluated the use of prototype chips to perform proteomics analysis on ubiquitating enzymes compared with traditional chromatography methods. They found significant time savings when using prototype chips, 20 minutes versus 90 minutes with traditional chromatography methods. This type of time savings can be especially important when working with large sample sets. These presentations highlight the breadth of our technology platform and our commitment to increase our platform's capabilities to broaden the areas of use for our customers and continue to open up our addressable markets. Overall, I'm encouraged by our growing pipeline of customers and the enthusiasm we're seeing across our end markets for 908 technologies. With that, I will now turn the call over to Joe for more details on our financials.