Good day, and thank you for standing by. Welcome to the 908 Devices Third Quarter 2021 Financial Results Conference Call [Operator Instructions]. 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 30, 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 e-mail to ir@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 finally issued 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 install base to over 1,700 devices across our 3 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 talk 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, Main Drug Enforcement Agency and the Quincy Police Department.

Tony Zook, 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, trial 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 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 involve into valuable enterprise accounts.

In October, Ohio Attorney General, David Yost, announced a pilot program for police departments in 3 cities where law enforcement officers will use our MX908 handheld devices for rapid mobile drug testing. In the press conference, A.G. Yost, noted that the MX908 is literally a crime lab in your hands.

We currently have over 20 MX908 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 MX908 device.

We are proud of the value that MX908 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, overdosed 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 on the sharp increase in fake prescription pills containing fentanyl and methamphetamine. This was the first advisory the DEA has issued in 6 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, 2 out of every 5 pills with fentanyl contain a potential lethal dose. And according to a recent study by the National Institute of Drug Abuse, overdose death in the U.S.

involving methamphetamine nearly tripled from 2015 to 2019 among people's age 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 an ounce 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 MX908 to detect pounds of hidden cocaine wrapped in 2 vests enabling officials to immediately seize the drugs. Lab tests later confirm the accuracy of the MX908 analysis.

In another instance, thorough examination of 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 MX908 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 rely on our technology to combat critical to life problems with easily interpretable, actionable results in second. 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, Boyner 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 new lens into the bioprocess workflow that allows for real-time process optimization.

Recently, at the Bioprocessing Summit in Boston, an Alexion Pharmaceutical Scientists presented results where our desktop device was used to mitigate amino acid miss incorporation and optimize feeding strategies for production bioreactor to rapidly achieve the desired critical quality attributes also known as CQAs.

We've previously shared our plan to create a bioanalytics 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 MX908 that adds 9 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 ZipChip, we recently launched an Oligonucleotide analysis kit.

Oligos represented the state class of therapeutics that include RNA, DNA and their structural analogs and are effective against a wide range of disease conditions. Traditional workflows for Oligo analysis are lengthy, often requiring the use of extensive liquid chromatography method development, along with harsh iron pairing the agents.

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 ion pairing agents.

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 domain. In May of this year, we announced a joint collaboration with Bio-Techne to develop an extended CQA workflow solution for protein characterization.

The pairing of Bio-Techne cIEF systems in 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 Bio-Techne at the CASSS Mass Spec Conference to demonstrate this workflow solution.

This need for rapid high-resolution identification and speciation of intact proteoforms was also highlighted by Boehringer-Ingelheim at the subsequent Cafepharma 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 demonstration 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 ASMS, there are a number of presentations on the application of our products and technologies. Presentations were from our own scientists as well as researchers from Amgen, Ligand 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 fall segments.

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 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 chip to reform proteamic 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 market.

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..

Thanks, Kevin. Revenue for the third quarter of 2021 was $12.5 million compared to $8.3 million in the second quarter and $6 million in the prior year period. Product and service revenue for the third quarter 2021 was $12.3 million compared to $5.8 million in the prior year period, representing growth of 111%.

The increase was primarily driven by our handheld devices, including initial shipments to the U.S. Army under the multiyear purchase order. Desktop revenue from our REBEL and ZipChip products grew 70% in the third quarter of 2021 compared to the prior year period, and more than 50% of the device placements were with new customers.

Recurring revenues, consisting of consumables, accessories and service revenue, grew 134% in the third quarter of 2021 compared to the prior year period.

Service revenue from our extended warranty and service plans from our install base and an increase in consumable revenue related to REBEL kits and initial sales of the Aero module, a new accessory for our handheld were key growth drivers in the third quarter of 2021.

License and contract revenue for the third quarter 2021 was approximately $0.3 million, relatively flat with the prior year period. Currently, we do not expect license and contract revenues to be a significant contributor of revenue on a go-forward basis. Our install base grew to 1,714 units, with 184 devices shipped during the third quarter.

We shipped 164 handheld devices and 20 desktop devices within the quarter. Gross profit was $6.8 million for the third quarter of 2021 compared to $3.8 million for the prior year period.

The increased gross profit was driven primarily due to the higher MX908 sales volume, which leveraged our fixed costs related to our manufacturing facility, and, to a lesser extent, our desktop devices. Offsetting this increase were investments in operations and service personnel.

Gross margin was 54% for the third quarter 2021 as compared to 63% for the prior year period. Total operating expenses for the third quarter of 2021 were $12.1 million compared to $5.1 million in the prior year period.

The increase was driven by headcount expansion across our business, primarily focused on our commercial organization, resulting in $4 million of the increase. The increase was also related to marketing activities and travel, which drove $0.8 million of the increase as well as increased expenses related to operating as a public company.

Net loss for the third quarter of 2021 was $5.2 million compared to $1.7 million in the prior year period. We ended the third quarter of 2021 with approximately $139 million in cash and cash equivalents. In addition, we had $15 million of debt outstanding. Turning to our outlook for 2021.

We expect revenue to be in the range of $41 million to $43 million, representing growth of 56% at the midpoint over the prior year period. This compares to our previously expected revenue range of $40 million to $43 million.

Regarding supply chain and market dynamics, we have taken a proactive stance and increased our inventory levels as quot lead times have grown. Over the course of the third quarter, this environment has worsened, and we continue to stay close to the situation and its potential risks.

Importantly, we design and build our products in-house and are able to qualify alternative vendors providing us a good degree of flexibility and protection. At this point, I would like to turn the call back to Kevin for closing comments..

Thanks, Joe. It's been an exciting year for us thus far at 908 devices as we continue to expand our installed base, deepen our customer relationships and broaden the capabilities of our platform to deliver more value to our customers. I'm encouraged by our progress and growing enthusiasm we are seeing across our end market.

We look forward to updating you on our progress. With that, we will now open it up for questions..

[Operator Instructions] Our first question comes from the line of Puneet Souda with SVB Leerink..

Your next question comes from Max Masucci with Cowen Company..

And your next question comes from Dan Arias with Stifel..

[Operator Instructions] At this time, there are no further questions on queue. I'll hand the call back to Kevin..

Yes. Thank you all. Thank you all for your time this morning. Have a great day..

All right. Thank you, ladies and gentlemen, and that concludes today's conference. Thank you all for joining. You may now disconnect..