Rob Spignesi
Analyst · Morgan Stanley
Thank you, Mike. Good morning, everyone. And thank you for joining us today. Before I begin, I would like to remind everyone that as we announced on August 12, 2022, the company’s Board of Directors initiated a review of strategic alternatives to determine the best path to maximize shareholder value. The Board is progressing through its review, and we will not have any further comments or updates on today’s call. As a reminder, there can be no assurance that the strategic alternative process will result in a particular transaction or any other strategic outcome. I will begin my discussion with a few highlights from the third quarter, followed by a review of the progress we are making with respect to customer engagement. Next, I will discuss the actions being taken and enhancements we are making to improve commercial execution. And finally, Sean will provide details of our third quarter performance and fourth quarter outlook. As an organization, our top priority remains accelerating Growth Direct System placements. My focus since assuming commercial leadership responsibility has been on enhancing customer engagement and experience and improving the efficiency and effectiveness of our sales team. We are pleased with our performance in the third quarter, which in most areas was ahead of the cadence we expected when we updated our guidance in August. Total commercial revenue in Q3 was $4.7 million. We placed 3 Growth Direct Systems during the quarter one system went to a U.S.-based biopharma customer in gene therapy field and the other two systems were placed with a European customer focused on mRNA therapies. As a result of our Q3 performance, we are reaffirming our full year 2022 commercial revenue guidance of at least $17 million. In-person access to customer sites continues to improve in the quarter, and I personally traveled to both Europe and Asia to meet with existing and prospective customers. Across my visits, it was clear that our value proposition is resonating, our commercial teams are connecting with new and existing customers and I’m excited about the sales pipeline building for 2023. We have also participated in a number of in-person industry conferences for the first time in over 2 years. We are on track to attend over 20 events and conferences around the globe this calendar year, and we have been hosting an increasing number of customer tours and hands-on Growth Direct sessions in the U.S. at our Lowell facility and in Europe at our Munich facility. In September, I was invited to participate in the PDA/FDA Joint Regulatory Conference in Washington, D.C. on a topic of Microbiology Lab of the 21st Century. I gave a presentation on how Rapid Micro thinks about and is shaping the lab of the future. Along with a Rapid Micro colleague, I took part in a panel discussion covering the micro QC lab of the future and industry 4.0 and how technologies such as the Growth Direct can deliver required automation, data integrity, speed and patient safety and move micro QC into the 21st Century. The panel also included a senior regulator who provided great insights into the regulatory landscape and strongly encouraged market participants to consider adopting new technologies that modernize the micro QC lab such as the Growth Direct. Additionally, representatives from global pharma companies were in attendance and interacted with the panel during the Q&A session. It was an inspiring exchange among the regulators, industry, and Rapid Micro and as we discussed the benefits of technology such as the Growth Direct that bring cost, efficiency, and patient safety benefits to pharmaceutical manufacturing. Also, in early October, we were a Platinum Sponsor of the 2022 PDA Pharmaceutical Microbiology Conference. Historically, this is one of the largest microbiology conferences of the year, and is one of the most important annual events for Rapid Micro. The conference is attended by global industry professionals, academia and regulatory authorities. This year at PDA, we featured an operational Growth Direct System and hosted several tech talks and poster presentations. RMB’s thought leadership in automated quality control was on full display and the customer attention we received was significant. Importantly, our executive leadership and commercial teams hosted a dinner that was attended by several dozen customers. This special event enabled deep engagement between Rapid Micro executives and key users and decision-makers at existing and prospective customers. As we have been discussing since the onset of COVID, our sales process is highly competitive, when we are in-person and on-site with customers, we gain a better understanding of the workflows and challenges in their micro QC operations. Being in-person also allows us a better environment to educate, and in the case of the PDA Conference and meetings at our facilities to demonstrate the capabilities of the Growth Direct System. The in-person demonstrations show how Growth Direct can meet the speed, data integrity and regulatory demands of the future of pharmaceutical manufacturing. In cases where customers have visited our facilities, we have been able to present our manufacturing capabilities, provide hands-on Growth Direct demonstrations and showcase our state-of-the-art, fully automated consumables manufacturing process. As we discussed last quarter, improving customer access is one element of driving system sales. Our other top priority is to enhance the consistency and effectiveness of our global sales team. In August, we continued to build on our marketing and lead generation capabilities by hiring a director of global marketing, who is experienced in building brand awareness and lead generation capabilities for multinational life sciences companies. The combination of increased infield prospecting by our sales team and expanded marketing capabilities is significantly increasing the number of quality leads we are generating. We have also tasked our commercial leadership team in implementing new strategies targeted at global key accounts. A meaningful portion of our funnel includes multi-system opportunities from existing customers looking to expand in Growth Direct rollouts across our global manufacturing networks. We are also developing exciting opportunities with a number of new, large and midsized customers. Looking forward, we expect to produce and publish an increasing number of science-based white papers and technical webinars that will continue to position Rapid Micro as the thought leader in the market. These efforts are expected to generate new sales leads and expand awareness of our innovative solutions. Now, I would like to shift gears and provide an update on our product development efforts. We are extremely pleased to announce our innovative mold detection product during the recent PDA Conference where there was a high level of customer interest and excitement. We are officially branding this new product, RMBNucleus Mold Alarm, and it will be available on the Growth Direct System through a software update. Mold Alarm is designed to rapidly and accurately detect and differentiate environmental molds from other organisms in the pharmaceutical manufacturing process. It incorporates enhanced data integrity and generates automated alerts as soon as a mold is detected in as little as 1 day. This capability allows for early intervention, mitigation and reduced risk of further contamination. Turning to rapid sterility, our beta process with our customer partner is ongoing. We are gaining and addressing valuable feedback on the product and confirming the core value of accuracy and speed to results. Sterility testing is often the final test before product release and can take 14 or more days to complete using the traditional method. We and our customers are excited about a Growth Direct enabled rapid sterility offering that will significantly accelerate time to detection and final results. We will provide updates as we continue to move through the beta process. To wrap up, we are pleased with the progress we are making to improve customer engagement, strengthen commercial execution and advance product development. Interest in our Growth Direct remains high and the introduction of Mold Alarm provides even more differentiation and value that we can bring to customers. And importantly, the actions we have taken to right-size our cost structure provide us with flexibility as we continue to advance our commercial execution and invest in expanding our Growth Direct platform. We remain confident that we have the right strategy in place, and we’ll continue to take appropriate actions to improve system sales in future quarters. That concludes my prepared remarks. I will now turn the call over to Sean to discuss our third quarter performance in more detail and provide some comments around our fourth quarter outlook. Sean?