908 Devices Inc. Q3 FY2022 Earnings Call

Good day and thank you for standing by. Welcome to the 908 Devices Third Quarter 2022 Financial Results Conference Call. 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 third quarter ended September 30, 2022. 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@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 Devices issued today. For a more complete list and discussion, please see the Risk Factors section of the company's annual report on Form 10-K for the year ended December 31, 2021, and in its other filings with the Securities and Exchange Commission. Except as required by law, 908 Devices 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 14, 2022. With that, I'd like to turn the call over to Kevin.

Thanks, Kelly. Good morning, and thank you for joining our third quarter 2022 earnings call. I'd like to start off by thanking our entire team for their tremendous effort in bringing the third quarter to a successful close. I'm really proud of their continued focus and dedication to support our customers' critical-to-life applications. We are operating in a challenging macro environment, and our team is going above and beyond. We delivered strong growth during the third quarter with revenue increasing 26% over the prior year period to $15.8 million. About 20% of third quarter revenue was from the remaining U.S. Army device shipments and 80% was from new business and other customers. While we are pleased with our third quarter results and year-to-date performance, we have begun to see a slowdown in our funnel with prolonged purchasing cycles over the summer months and into the fall. We believe this is largely due to the adverse impact of macroeconomic factors across the markets we serve. We expect these headwinds and impairments to continue over the next couple of quarters. Given this impact, we now expect full year 2022 revenue to be in the range of $46 million to $49 million, representing annual growth of 13% at the midpoint of the range. As discussed on our last earnings call, progression of a few larger handheld opportunities would be required to achieve our previous full year guidance, and we've seen protracted cycles in test trials to pilots to enterprise conversion. Despite this near-term pressure, we firmly believe the opportunity for rapid and robust analytics at the point of need is as strong as ever. This positive view was reinforced at our user meeting in September, Critical Mass 2022, which covered the full breadth of our product platforms and their applications. This event brought together more than 175 customers, both virtually and in person to share their success using our mass spec devices to provide rapid and robust actionable information at the point of need. We heard from customers serving and spanning industry academia and government, including Boehringer-Ingelheim, MIT, Clemson University, Ohio Bureau of Criminal Investigation, and the Fresno, California Police Department. It was truly inspiring to hear the impact that our technology is having to advance bio-therapeutics and combat the opioid crisis. Now I'd like to provide a brief update on our progress across the five focus areas we set for 2022 to drive growth over the longer term. Starting with our first objective of driving customer adoption. For our desktops, we are continuing to see underlying demand for more advanced therapeutics. The need for more process control and the steady increase in proteomics and metabolomics research, all of which fuel the biopharmaceutical industry's long-term growth. However, the shift in the macro environment has begun to slow some near-term demand for our desktop devices, particularly in cell and gene therapy applications, where technology is being adopted to support the process development preclinical space. The Alliance for Regenerative Medicine recently issued its first half 2022 report on advanced therapies, which noted that 2022 has already been a record year for the approval of new cell and gene therapies, with several other therapies on track for regulatory decisions in late 2022 and 2023. However, the number of ongoing clinical trials globally decreased by 13% from the end of 2021, and investment levels have slowed after two record-breaking years. Across our desktop, we continue to see orders from a fairly even split between new and existing customers. With the REBEL device, we continue to see traction with additional units in several of the top 20 pharma companies, and with some of these companies ordering their second or even fourth device. With our ZipChip device, Genentech ordered its fourth unit during the quarter. In a paper published in September in Analytical Chemistry, Genentech researchers noted the device's ability to quantify a peptide exchange at high throughput and high sensitivity in a CAR-T cell therapy application. Overall, we believe that our penetrate and radiate strategy, in which we work to penetrate new accounts, create a foothold, and then radiate across these enterprise accounts, will continue to drive broader adoption and acceptance over the long term. Turning now to our handhelds. The opioid crisis shows no signs of abating. In August, the National Center for Health Statistics, a division of the CDC, announced that U.S. life expectancy decreased last year to its lowest level since 1996. While COVID-19 was the primary cause of the decline, another leading cause was unintentional death, mainly comprised of overdoses. This crisis continues to be a major driver of customer adoption. There are several recent news reports that highlight the severity of the ongoing crisis. In September, a news report highlighted a shortage of Adderall used to treat ADHD and noted the dangers of sourcing the drug on the street as these counterfeits contain fentanyl and other drugs. The FDA has confirmed the Adderall shortage, noting that several generic forms may not be available until March 2023. In Rhode Island, a district attorney's authority seized more than 660,000 counterfeit Adderall containing methamphetamine. Also in September, the DEA issued an advisory warning of brightly colored fentanyl, also known as rainbow fentanyl, used to target young children. The DEA has seized multiple forms of rainbow fentanyl, including pills, powder, and blocks that resemble sidewalk chalk. Finally, in August, the Australian Federal Police and the Australian Border Force announced the seizure of the largest festival shipment detected in Australia, preventing more than 5 million potential legal doses of the drug from hitting the streets. While the DEA has noted that fentanyl is the deadliest drug threat facing the U.S., we are seeing more and more evidence of it becoming a global crisis. These sobering statistics and alarming news reports continue to highlight the need for first responders and other frontline workers to have trace chemical detection at the point of need to combat the spread of highly dangerous drugs. A case in point is the increase in drugs coming in personal mail and legal correspondence at correctional facilities. We've seen several orders from regional county jails for the MX-908 device throughout the year, with another order in the third quarter for five devices from a Department of Corrections based in New England. As previously noted, we built a pipeline of testing, trials, and pilot programs to drive enterprise adoption of our handheld devices. In the third quarter, we expanded in the existing enterprise account of the U.S. Army, receiving an order for $3 million for Aero modules compared with their fleet of MX-908 devices. Once last year, the first of its kind Aero module enables users to monitor, detect, and identify vapor and aerosol hazards quickly and safely. Turning to our second objective, accelerating commercialization. As of the end of the third quarter, we now have over 220 employees worldwide and are close to reaching our goal of 80 commercial team members. That said, we continue to be thoughtful in reviewing planned commercial expansion across all our regions amidst this uncertain macro backdrop. Turning to our third objective, developing and advancing our product portfolio, we continue to unlock our platform's capabilities through consistent releases of additional analytics, assay accessories, and data integration in order to increase areas of use for our customers and to penetrate our addressable market. For our handhelds, we expanded the capability of our MX-908 device to detect eight highly toxic and illegal pesticides. These pesticides are being used to grow illegal marijuana primarily on federal land, posing a threat to the environment, water sources, wildlife, and people. The issue is particularly critical in California, where the state is expanding its multi-agency seasonal illegal marijuana eradication program. This will now be a year-round effort, aiming to prosecute underlying labor and environmental crimes. Previously, federal personnel had no safe and reliable method to conduct pesticide testing at the site of illegal marijuana grows and had to send samples to a central lab, often waiting several weeks to conduct a safe site remediation. In January of this year, we announced a research collaboration with the United States Forest Service and Agency of the United States Department of Agriculture to extend the capabilities of the MX-908 to detect these illegal pesticides. For our desktops, we continue to develop and refine tools to meet customer needs. We introduced Version 2.0 of our spent media analysis kit for REBEL, which provided an additional and enhanced calibration for improved accuracy and quantification results. We are developing another focused REBEL kit to be released in the first half of 2023 that pushes the boundaries of analytical performance for a specific set of amino acids commonly measured in most applications. In regard to our acquisition of TRACE Analytics in August, we are extremely pleased with how well the TRACE team is integrating with our R&D team to further our online development efforts. As you may recall, our acquisition of TRACE provided us with online acceptor bioreactor sampling and biosensor technology, which is a central addition to our micro fluidic technology color and will help us unlock more of our total addressable market. Their technology, in single-use and reusable configuration, has been proven in mammalian cell culture and micro-bio fermentation at all levels of the bioprocess chain from research and development to large-scale production. At our user meeting, Wolfgang Künnecke, Trace Analytics Founder and now the Head of our Bio-analytics R&D, presented the benefits of automated control of glucose and lactate in a process development lab, which includes cell-free, sterile, and safe sampling with no volume or prep required. As we have noted, our main focus this year has been to build upon the capabilities of our existing products and expand the reach of our technology platform. In 2023, we plan to shift our focus to releasing two new devices. We are excited to share more details early next year as we expect them to be impactful in 2023. Turning to our fourth objective, broadening our bio-analytics platform as more advanced therapies enter the pipeline. Biopharma manufacturers need to identify and understand critical process parameters and their impact on critical quality product attributes during process development and the entire bio-manufacturing workflow. Our devices are well-positioned to meet this need. We continue to collaborate with key industry partners and academic institutions to demonstrate the value of our technology in providing rapid and robust information that enables manufacturers to accelerate bio-therapeutic workflow. This value has been highlighted at a number of industry events over the past few months. Our collaboration with the Center for Process Innovation and Independent Innovation Organization in the U.K. demonstrated the value of at-line cell culture media analysis to inform feeding strategies for improved cell growth. CPI process engineers use real-time data from the REBEL to optimize nutrients, resulting in an increase tier by up to 40% and a reduction in toxic metabolite accumulation and a significant reduction in design of experiment times. These results were recently presented in a webinar hosted by BioPharma International Magazine and a poster at the CE Pharma Symposium in mid-September. Independent data from our REBEL analyzers, such as this, is key to demonstrating our value proposition, enabling broader adoption as process engineers conduct amino acid analysis more regularly. There were several other posters presented by our collaborators at the CE Farm Symposium and the Cash Mass Spec Conference, including Bio-Techne, Cogen, Thermo Fisher Scientific, and Protein Metrics. These posters highlighted the use of our ZipChip device for several applications, including characterizing oligonucleotides, peptide mapping of recombinant AAVs, and charge varying analysis of small molecules. ZipChip benefits highlighted in these presentations included high resolution and high sensitivity comparable to LCMS method but with much faster separations and minimal sample volumes. And in the case of oligos, no harsh pairing reagents. At the Bioprocess International Show, part of Boston Biotech Week, our collaborators at Johns Hopkins University gave a presentation on leveraging the power of at-line amino acid measurement with the REBEL to enable complex bioprocess modeling. Also at the show, a principal scientist from Cypogen, a biotech company, presented on mass spec-based characterization workflows in biopharmaceutical development labs and noted ZipChip's capability to perform high-resolution separations while minimizing sample prep burden. Finally, at our user meeting, scientists from Boehringer-Ingelheim praised ZipChip for its very fast separations and high sensitivity in characterizing product quality attributes in oligonucleotides and monoclonal antibodies. Additionally, MIT researchers underscored REBEL's value in their ability to rapidly monitor and profile nutrient consumption of recombinant AAV-producing cells in the perfusion process. We are delighted to hear our collaborators and biopharma customers highlight the value of their desktop devices in characterizing multiple product quality attributes and controlling key process parameters, which ultimately leads to improved efficiency and robust product quality. And finally, turning to our longest-term objective, laying a strong foundation. We see a clear and emerging need for accelerating mass spec-based workflows to address proteomics and metabolomics opportunities. We continue to foster cadence and publications, technology, and research with proteomics academic institutions and research partners to support future product launches and workflows specific to the proteomics domain. In the areas of metabolomics, an academic research paper in the journal Metabolites focused on characterizing cell-to-cell signaling molecule levels in healthy versus Type 2 diabetes-affected human pancreatic cells. Researchers used ZipChip with a broker mass spectrometer and noted its fast separation time of within three minutes, along with a high confidence of identification. As previously shared, we are advancing our microfluidic chips to address emerging proteomic and metabolomic opportunities. Last month, we hosted a meeting of our Proteomic Scientific Advisory Board, where key opinion leaders provided guidance and feedback on the direction of our proteomics facing research and development efforts. Our Scientific Advisory Board members were enthusiastic about our continued development of on-chip peptide pre-concentration from the ZipChip platform, providing feedback on throughput and robustness requirements to address the emerging low-input proteomics market. We are fortunate to have this remarkable group of thought leaders share their insights as we advance our development efforts. In summary, we remain encouraged by the value our technology platform is providing to our customers to break mass-spec out of the confines of a centralized laboratory and bring it to the point of need. While we face some near-term macro pressure, we continue to focus on serving our customers, expanding our user base and making our technology even more accessible to broader audiences, which opens doors for new users and applications. With that, I'll now turn the call over to Joe for more details on our financials.

Thanks, Kevin. Revenue for the third quarter 2022 was $15.8 million compared to $12.5 million in the prior year period, representing growth of 26%. This increase was primarily driven by desktop device placements, an increase in handheld recurring revenue, and an increase in service revenue across both handheld and desktop devices. About 20% of our third quarter revenue was from the remaining U.S. Army device shipments, which compares to approximately 40% of the prior year period total revenue. Handheld revenue from our MX-908 product was $11 million, an increase of $1.7 million compared to the prior year period, representing growth of 18%. Desktop revenue from our REBEL and ZipChip products for the third quarter 2022 was $4.4 million compared to $2.9 million in the prior year period, representing growth of 51%. Recurring revenues, consisting of consumables, accessories, and service revenue for the third quarter 2022 was $4.5 million compared to $2.2 million in the prior year period, representing growth of 105%. The increase in recurring revenues was evenly split between an increase in service revenue and an increase in Aero modules. Our installed base grew to 2,317 units with 175 devices shipped during the third quarter. This included 150 MX-908 handheld devices, 18 REBEL desktop devices, and 7 ZipChip interface desktop devices. Gross profit was $9.3 million for the third quarter of 2022 compared to $6.8 million for the prior year period. The increased gross profit was driven by an increase in product and service revenue. Gross margin was 59% for the third quarter 2022 as compared to 54% for the prior year period. The increase in gross margin was due to higher service revenue and average selling prices for our devices, offset in part by higher personnel and operating costs. Gross margin was 57% year-to-date. Total operating expenses for the third quarter of 2022 were $16.5 million compared to $12.1 million in the prior year period. This increase was driven by headcount expansion across our business, a $1.2 million increase in stock-based compensation, and an increase in marketing activities and travel expenses. Net loss for the third quarter of 2022 was $6.3 million compared to $5.2 million in the prior year period. We ended the third quarter of 2022 with approximately $194 million in cash and cash equivalents. In addition, we had approximately $15 million of debt outstanding. Our trailing 12 months of cash used for operating activities was $25 million as of September 30 and was approximately $29 million for the full year 2021. With approximately $180 million of net cash as of quarter end and our cash utilization, we have multiple years of runway to focus on our product innovation, market penetration, and commercialization efforts we have implemented over the last few years. Now looking ahead for the remainder of 2022, we now expect full year revenue to be in the range of $46 million to $49 million, representing 13% growth year-over-year at the midpoint of the range. There are a few notable impacts to our guidance since our earnings call in early August. On our Q2 earnings call, we mentioned we are keeping a close eye on potential macroeconomic factors that could impact our execution. Specifically, our team driving strong adoption of our handhelds through the end of the U.S. Government fiscal year, capturing year-end biopharma spending, and mitigating continued disruptions in the Asia-Pacific region. Unfortunately, we have seen opportunities push out beyond the end of the U.S. Government fiscal year. As Kevin mentioned, progression of a few larger handheld opportunities would have been required to achieve our previous guidance range, and we have seen protracted cycles in test trials to pilots to enterprise conversion. We believe in part, this is due to prioritized resources for Ukraine and surrounding regions, the diversion of resources to the southern border to assist with the migrant crisis taking away from drug interdiction, and COVID recovery. In addition, for our desktops, our revised guidance range now assumes desktop revenues to grow by approximately 30% over the prior year. While this growth rate is 2x the growth rate of the overall business, it reflects some impairments in the fourth quarter from macro factors, including the likely level of year-end capital spending that is prioritized for new technologies. Specifically, these factors include talent migration across organizations, resulting in delayed adoption and a training, retraining burden; large capital purchases canceled for associated bioreactors, thus delaying the priority of our devices; and layoffs at small and large biotechs, resulting in cancellations for our consumables. At this point, I would like to turn the call back to Kevin for closing comments.

Thanks, Joe. I am confident in our long-term trajectory and feel we are laying the groundwork for both near-term and long-term success. In the near term, our team remains focused on progressing our handheld opportunities through test trials to pilots and extending to enterprise accounts, catalyzing reference desktop accounts across top pharma for our desktop to enable our penetrate and radiate strategy, scaling our operations, and ensuring the highest quality products in the face of ongoing supply chain pressures. Support our customers pre and post, to help ensure proficiency on our devices as they face unprecedented employee migration. And bolster service and support reach, particularly in Asia-Pacific, in the face of continued China lockdown and a limited ability to transit through the region. As we look ahead to 2023 and beyond, we believe 908 Devices is uniquely positioned to capture the opportunity in front of us. We have multiple new product releases slated for 2023 in the bioprocessing monitoring space with the first being launched early in Q1 and the next shortly thereafter. We have a diversification and defensive position with our handheld offering in the forensic space and have seen order growth of more than 50% year-to-date beyond the U.S. Army device orders. We believe these handhelds will continue to be critical with rising geopolitical uncertainties and the ongoing crisis. And finally, we have a strong cash balance with the runway into 2025 as we've remained efficient and thoughtful on spending and headcount. With that, we'll now open it up to questions.

Our first question comes from the line of Max Masucci from Cowen.

To begin, it would be valuable to get your insights on the trends you are observing in Biologics preclinical activity, as well as any feedback from Critical Mass. Additionally, could you clarify whether we need to adjust our expectations for REBEL and ZipChip placements and utilization in 2023?

Yes, Max. Sure, happy to. And yes, maybe we can just dive into some of the bits you mentioned on the kind of the spending and those profiles for the desktop customers. As mentioned in the script there, I think we are just seeing a lower level and slowdown a bit across the board for some of the handhelds and desktops, particularly as mentioned, just seeing some slowdown in the large capital purchases with bioreactors that delays the priority for our devices. And we're seeing layoffs within our customer base. And we're just, frankly, not seeing the same amount of year-end capital spend at this time for new tech, which is ours. And as we're really not riding a replacement cycle for it, and that gives us less visibility than maybe some of the large cap instrument companies. And we're selling, as you mentioned, really into that preclinical space with these REBEL desktops and dollars are tightening. So all of that, we really see that it isn't a 908 specific phenomenon, but an industry phenomenon and you can dive into that deeper and think about biopharma spending in particular, and you can see a slowdown in that cell and gene therapy space, which we've been trying to gain a foothold in. We've mentioned in the past about 20% of our levels are in that space. And we're certainly seeing more moderation in Q3 across that space, but our unit numbers are pretty small and modest. We're always trying to slice and dice that. But in general, I would just say that we have seen that slowdown in deal velocity, so...

And Max, you were asking about REBEL and looking forward and contemplating our revised guidance which has reduced growth for REBEL, given some of the constraints that Kevin just mentioned on the macro environment, especially with the adoption of the new technology. As noted earlier, talent migration across the organizations, large capital purchases canceled associated with bioreactors, layoffs at small and large biotechs. And as we look at the delta of how we brought down our guidance, we attribute approximately two-thirds to handhelds and one-third to desktops with the change in desktop coming from slower-than-anticipated funnel progression for our REBEL. We are being cautious. We may not see the same year-end budget flush resulting with those new placements. And we anticipate it could be a couple of quarters of impairment as the volume patterns need to change that preclinical level that you mentioned.

Okay. Great. And then we haven't seen the 10-Q yet, but it would just be great to hear about some of the regional demand trends that you experienced during the quarter. Just generally, whether you've seen any major uptick or downtick in growth in any of the regions that you break out?

You'll see our Q hit to file hit the line before market here. But geography, it's about 80% in the Americas to date.

Yes. And if you think specifically in Europe, as we've been really trying to bolster over this year what we're doing internationally, broadly, mainly in Europe, but some in the Middle East and a bit in APAC. Yes, as Joe said, the EMEA is probably around 15% of our revenues, but we do see that there's additional opportunity there. And we're selling through distributors today, and so less of an exchange impact, but we can talk through any dynamics there. So not all downside, I would say, across that Europe region, specifically if you think about some of the pressures from the Ukraine war and U.S. partner nations, and it's causing a bit of a look around to see if they have the best-of-class detection capabilities. APAC has been a bit harder for us and has been about a small percentage of revenues. It's maybe 5% of our year-to-date revenues. But we sell through distributors there, but we're not seeing the upside due to those changes that multiple parties have mentioned there out there, say, being able to get our small team to be able to transit and support applications and board our units across the region. So we're we actually have our Head of Commercial in right now as we speak.

That makes sense. One final one for me. The gross margins have delivered solid outperformance versus our expectations over the past few quarters. Rising ASPs for devices was cited as a contributing factor to the strong gross margins this quarter. So, would just be curious, if you could give us a bit more detail around how pricing has trended, maybe both on the devices and the consumables side?

Happy to, we've been pleased with the gross margins year-to-date and within the quarter. ASPs have been a piece of that. An element to whether it's to distribute more direct here in the U.S. and with about 80% here in the Americas. But we did put some price increases in effect at the beginning of the year that started to kick in earnest here in Q3, a bit in Q2 as we elevate as well and other consumables where we did not increase that pricing for 2022. So a lot of that ASP benefit is coming through the devices themselves. We'll take a hard look at it going forward based on the different market factors and what we do for '23, but it is good to see our customers see the value of the technology and leaning forward to purchase at that higher price point.

Great, appreciate you taking the questions.

Our next question comes from the line of Daniel Arias from Stifel.

Kevin, on the MX side, can you just talk about the services revenue stream that you expect to come out of the Army contract and then be represented in the 2023 revenue base? And then just on overall revenue growth, given the way that we're finishing here on the year, and the roll-off of the Army contract, but also some of the order growth numbers that I think you mentioned. How should we just think about growth next year? To what extent do you think the additional MX system deals can offset the Army contract? And then when you look at total year-over-year growth, realizing that you're going to guide formally in 4Q, what is the right way to think about the year-over-year there?

Yes, I have a little bit on the Army side. As we mentioned, about 20% of our Q3 revenue was Army and 80% was from other business outside of that. With that said, there are ongoing responsibilities on the service side.

That's right, Kevin. And about that service contract, there's about $5 million of ongoing service revenue over the period where they committed to technology upfront, and I think I disclosed that it goes through September 2025. So about three years of service where that gets recognized on a recurring revenue basis. Within the quarter, we did see the U.S. Army adopting the Aero capabilities and had about $1 million of recurring revenue ship related to those Aero modules in the third quarter, and the remaining portion of that additional order will be here in Q4. Moving forward... Yes, I mean if we take your question about what does 2023 look like with that backdrop and... Totally here. But if we just step back at a high level and think about it, yes, likely more moderate growth in the first half of the year and particularly as some of the volume patterns need to change on that preclinical level to support our desktops. We certainly don't want to see any more macro impacts that deteriorate that earlier. We are seeing that, as we mentioned, kind of a couple of quarters with a trend there. We really don't believe that that much that way to commit to what it is we have set up for 2023 in terms of new products, and we're engaging now with key opinion leaders on that. The first will launch in early Q1. In leveraged business expands our analyte panel a bit and many may provide an on-ramp to further level adoption, and we may have device releases slated to follow in short order. So we're definitely not standing still there as we leverage our R&D machine. We really have been impressed with TRACE analytics and where that can go and the great team and great technology that brings. So, yes, based on where we're at, I'd say, more moderate, but incremental from new products, getting that positive feedback now, and thus far really should make us more diversified and give us more opportunity and drive more conversations next year and all very differentiated new products we're contemplating. So we believe that to be an important contribution for us in 2023.

Okay, that's helpful. Following those comments about the REBEL side, do you anticipate that the macro concerns you mentioned will affect pull-through in Q4 compared to Q3 levels? Or is that more related to instrument placement? Kevin, I understand your point about the industry-level data for cell and gene, but you are still in the early stages of entering that market. Are you suggesting that the new trial start trajectory is surpassing the overall level of activity? The ARM report indicates that there are over 2,000 trials globally, and we expect your installed base to be around 150 or 200 by the end of the year. This suggests there is significant opportunity and room to place systems. Can you discuss the selling environment and how conversations are evolving within such a large overall market? Thank you.

Yes, absolutely. I mean from the selling conversations, you're right, only about 20% of our REBELs are going into that cell and gene market. And while it is slowing, you would expect there's additional opportunity to pursue there as well as outside of cell and gene. I think what we're just generally seeing down is that people are slowing down their desire to grab new technology and change the way they're doing it. We've literally had labs that have been good pull-through customers for us, go from having a dozen employees down to two, and they're trying to build back again. So there's a lot of training, there's a lot of retraining. There's a lot of focus on taking the limited dollars they have and applying it to a replacement product or something status quo, and it takes work to adopt the new product, new technology and get across that chasm, if you will. And it takes effort on the customer side and on the 908 side, and it's just a new way of doing things. So I'd say across the board with biopharma spending, we're just seeing more of a reluctance and a slowdown from that perspective.

On the pull-through. Dan, you're asking about the pull-through in device versus consumables. And as I noted, definitely an impact on the device side here in Q4 as we look to finish up the year and moving into 2023. But on the REBEL kits, we are striving for that active user to be at that approximately one kit per month on average, and that's that 40% pull-through for those users. We have been seeing some pressures on that. Currently, we require closer to 0.5 kits per month versus one kit a month for those active users. Some of those are the employee turnover that we're seeing within and need to train and retrain the project priority within our customer accounts needs to be clear to kind of drive them to cross the chasm per se on the new technology adoption and getting, so it's not the devices but also some on the consumable pull-through as well.

Our next question comes from the line of Puneet Souda from Leerink.

So this is a meaningful reduction in guidance this year. I mean, obviously, the questions are for 2023. I think, Kevin, the question that I have, it really is you have 80 or so folks in the commercial organization today. They were hired last year, they're fully trained and productive right now. So you essentially have a strong sales force. You are seeing some slowdown in clinical trials. You were still early in this ramp. You have an innovative product that is highly differentiated versus the rest of the market in terms of the accuracy, the ease of use, all of those benefits are there. This is still very much a still process development in clinical trials. So it's just sort of the challenging to see sort of why that slows down so meaningfully here? And maybe can you talk to us about sort of what's your line of sight there? When do you think this can sort of improve? What are you hearing from the customers on the REBEL side? And then I have a follow-up on 908 MX-908.

Certainly. Regarding the guidance adjustment of $6 million, we attribute roughly two-thirds to handhelds and one-third to desktops, particularly driven by the REBEL product. From a customer sentiment perspective, we are experiencing a general slowdown in the adoption of new technology. While we believe the REBEL offering is compelling due to its capabilities and efficiency improvements, we recognize the need to emphasize this value proposition to our customers. Currently, they often send samples to a central lab, but we are collaborating with them to alter their feeding strategies and bioreactor monitoring in order to enhance outcomes and efficiency. We've demonstrated some of this at our critical mass event and through the CPI data. In terms of our sales team, we have 80 members in sales and marketing globally, targeting around 80% productivity. We're close to achieving that goal, but fluctuations do occur, and we aim to be strategic in our regional distribution. We're committed to growth, balancing the size of our team carefully due to occasional turnover, which is not greater than what the industry is experiencing. Being a small company means we have limited redundancy across geographies. Typically, productivity and top-line impacts from reps become clearer over time. While new reps contribute significantly, we've also seen some seasoned reps not achieving expected success this year. Thus, there is a broader macro context impacting our efforts to introduce and adopt new products.

Okay, that's helpful. And actually, a quick follow-up on REBEL. In terms of the new product launch, the online product that is expected to, correct me if I'm wrong, till 2023. What is the timing of that? And what can you tell us about that? I don't know if Chris is on the call, but what can you tell us about that product and how that's setting up?

Yes. Yes. I'm happy to cover that. We've always said that the REBEL online, if you will, is more of a 2024 situation. What we're really excited though is to offer other online products that can be a prelude for that and leveraging our TRACE analytics acquisition. So we're very excited to have the first one of those get out into the market in early Q1 and a second one shortly thereafter. And so all these efforts are really trying to steer and push us further into that bioprocessing 4.0 domain and adding to the offering of our analytes and the process parameters, but also introducing some elements of process control and getting us out there with that online analytics capability that then is more of a two-step as we see to accelerate our REBEL online efforts, both development and commercially. So we're very excited about it and getting a strong road map where we've got some of these future products already out with KOLs and are getting some good feedback. I'm happy with that acquisition of TRACE analytics, very differentiated, and it enables online capability for multiple products that we've got on our roadmap here. And I think that's a big differentiator from where 908 sits in that we're able to spin new products and adapt because we have a pretty comprehensive set of technologies here. But yes, I'm very excited for that roadmap to come.

Could you discuss how the application base for MX-908 is expanding in 2023? We know that Army and Forensic applications are significant right now, but what kind of diversification can we expect in terms of product offerings and applications?

Yes, sure. The handheld, as you mentioned, are largely going into that forensic set of those applications in some way back to fentanyl and the opioid crisis and whether those are aerosol hazards or counterfeit drugs that people are swabbing on a surface and continuing to see growth there outside of the U.S. Army. We mentioned good growth in orders year-to-date outside of that U.S. Army work for those. You're right, we are also always trying to expand our analytic panel and capabilities on our handhelds as well, and we did just announce more work we've been doing with the USDA, specifically the U.S. bar service to develop a pesticide library. It's really for the environmental impact and safety impact around illegal use of pesticides on federal lands. And we do see that, that's a way for us to just get out there, explore, and have more conversations in that space. But yes, I think we're excited where the handheld will continue to grow, and we now have over 1,800. And as we mentioned before, we're working on new products there as well that will keep shrinking down the form factor, and we think will be compelling driving cycles over the next couple of years as well. So yes, I think it's a good platform for us that we're continuing to invest and really want to own that handheld detection space.

Okay, thanks, Kevin.

Our next question comes from the line of Madeline Mollman from William Blair.

This is Madeline Mollman speaking on behalf of Matt Larew. I have a quick question. In the past, you mentioned that one-third of REBEL users had open blanket purchase orders for consumables, indicating they were ordering multiple kits at once. Have you noticed any impact from these bulk-buying customers in terms of destocking? Is there any concern that after making large purchase orders, there will be less demand for consumables in the future?

Yes, we have observed that customers are opting for a blanket purchase order system where they commit to a specific number of kits, which could be six or twelve, for delivery. Generally, they sign up for about one kit per month and can adjust their orders based on their project timelines. We have experienced both scenarios where they either increase or decrease the order. However, due to some broader economic factors, we've noticed that some customers have experienced layoffs and have reached out to us to request delays or cancellations of their orders.

Got it. And then just in general, in terms of the recent election, do you see any change to government spending priorities that would make an impact on investment in your offerings?

Yes, that's a great question. I mean, we're continuing to monitor that very closely. We do have a legislative effort where we try to work on the advocacy side as well. Fentanyl is very important. We've certainly seen some headwinds with what we call a more of a macro level with just limited funding that's been available to some of our customers, particularly ones on the southern border across the board, multiple organizations really hit by the migrant crisis there, where a lot of resources are being taken from technology and needed for humans to help with that problem. So we'll have to see what transpires here with the elections and near-term and longer-term sentiment. But I think we do have good visibility. We shared publicly in the past that Kevin McCarthy has been given a first-hand demo through the Ohio BCI of our technology set, and that was all positive. And so I think there is an awareness that more needs to be done for the fentanyl and opioid crisis. Joe and I were just mentioning that there were just articles on our drive in this morning, more about counterfeit drugs. So I think the government certainly views this as a problem. I think it's also becoming more of a global problem. And so I think we'll continue to see resources on it, but maybe too early to tell us as a particular change of it.

Thank you.

Thank you. I would now like to turn the conference back to Kevin Knopp, CEO of 908 for closing remarks.

Yes. Thank you. Thank you all very much for your attendance, and we appreciate your time this morning.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.