3/14/2022

speaker
Operator
Conference Call Operator

Thank you for standing by, and welcome to ACOIA Biosciences' fourth quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker 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. Please be advised that today's call is being recorded. Should you require any further assistance, please press star 0. I would now like to hand the call over to Priyam Shah, Head of Investor Relations. Please go ahead.

speaker
Priyam Shah
Head of Investor Relations

Thank you, operator, and thank you to everyone who is joining us today on this call. I'm Priyam Shah, Head of Investor Relations at Akoya Biosciences. On the call today, we have Brian McElligan, Chief Executive Officer, and Joe Driscoll, Chief Financial Officer. Earlier today, Akoya released financial results for the fourth quarter ended December 31st, 2021. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. For a list and description of the risks and uncertainties associated with ACOIA's business, please refer to the risk factors section of our Form S-1 filed with the Securities and Exchange Commission on April 15, 2021. We urge you to consider these factors and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 14th, 2022. ACOIA disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will turn the call over to Brian.

speaker
Brian McElligan
Chief Executive Officer

Thank you, Prem, and good afternoon, everyone, and thank you for joining us today. Okoye had an incredibly strong and eventful fourth quarter of 2021 as we announced powerful new spatial biology solutions, reached key clinical milestones, established groundbreaking partnerships, and appointed additional industry leaders to our management team. Our continued solid execution is reflected in our strong financial results for Q4 and the full year 2021, generating record revenue of $16.2 million for the fourth quarter, and $54.9 million for the full year, representing a 30% top-line annual growth. In Q4, we saw almost 70% annual growth in reagent revenue, which is fundamental to our business strategy of driving expansion of system utilizations and recurring consumable revenue. We finished the year with $113 million in cash, providing us with a strong balance sheet with ample runway and flexibility to continue to invest in the business. And as a company 100% dedicated to spatial biology, we at Akoya believe that spatial phenotyping will inevitably become the standard for analyzing any tissue sample. Our platforms are complete end-to-end solutions providing instruments, reagents, software, and services to address the spatial biology needs of our customers from discovery to translational research and ultimately for clinical use. We now have nearly 700 instruments installed worldwide and approximately 500 market leading high impact publications using our instruments. Our year over year growth in publications went from 109 in 2020 to nearly 280 in 2021 and represents one of the key leading indicators of the growing adoption of our platforms. This adoption and demand are driven out of the simple principle that the spatial data we provide is paramount to understanding the fundamentals of biology and the complexities of disease. Spatial analysis is one of the fastest growing segments in discovery and translational research with applications in areas such as oncology, inflammatory disease, neurology, transplant medicine, and more. Following our IPO, we immediately expanded our research and development efforts to accelerate the launch of new best-in-class spatial platforms and, in parallel, scaled our commercial team to drive adoption and utilization of our existing and new offerings. At our Spatial Day in December and at the J.P. Morgan Healthcare Conference in January, we discussed our new product offerings, outlined our strategic priorities for 2022 and beyond, and those priorities and our key areas of focus are as follows. First, we will deliver new, robust spatial biology solutions to the market that have the speed and the flexibility and the multiplexing capacity that our customers now demand. Next, with this increased robustness, we will provide ongoing expansion of our ready-made content, including multi-omic capabilities with a range of solutions for RNA and spatial transcriptomics. Finally, we will continue to partner with leading industry and academic medical centers to expand on our successes in the translational and clinical trial market, advancing our goal to establish a COIUS platform as a robust clinical solution. Now, one brief reminder, to better align our product naming conventions with these priorities, we recently completed some product rebranding. The Codex platform has been renamed the Phenocycler. And aptly so because the platform provides unbiased high parameter capabilities as an in-situ reagent delivery device. It's cycling reagents on and off of the tissue. And it does so by physically integrating and pairing with our customers' existing microscopes to create one integrated solution. The Polaris platform has been rebranded as the PhenoImager HT as it provides robust high throughput imaging with the best optical technology in the market. And it was really purpose-built to serve the translational and clinical markets. Historically, even though the phenocycler, formerly the Codex, was designed to integrate with our customers' existing microscopes, the majority of customers were nonetheless buying a new third-party microscope to ensure that they had a dedicated system to run the Codex assay. And beginning in January, with the launch of the fusion system, Customers will now preferentially choose our fusion over a conventional third-party microscope. Capturing the microscope revenue with the phenocycler is an obvious and core driver for Akoya for this year. The fusion contains the same leading optical capabilities as the HT, formerly Polaris, but with a smaller footprint and was explicitly designed to integrate with the phenocycler. Because of the powerful optics, a key benefit of the phenocycler fusion combination is that our customers can now run high-plex codex experiments nearly an order of magnitude faster, enabling larger, more meaningful studies and a contracted time to result. This speed improvement accelerates time results, drives expanding pull-through revenue per instrument. There is an equally powerful secondary benefit to coupling the fusion with the phenocycler. Our customers can use the phenocycler with the fusion for high plex interrogation of tissues and then use the fusion as a standalone to run high throughput validation studies at lower plex with a throughput of 100 samples per week. This modular design and tunable workflow enables the flexibility of our customers to do biomarker discovery and biomarker validation on the same platform. It's effectively two solutions in one. We had limited shipments in Q4, and the full commercial launch of the phenocyclofusion system commenced on January 14th of this year. We're encouraged with the initial customer interest and immediate commercial success and look forward to providing updates on our successes throughout the course of the year. Now, with this increase in speed and throughput that the phenocyclofusion provides, we're also expanding both our content menu and our multiplexing scale. Throughout 2022 and going forward, you will see us launch expanded antibody content for fresh frozen, for FFTE, human mouse in areas such as cancer and inflammatory disease and neurobiology. Now with faster speed and more content, we're also expanding the multiplexing of the Codex assay from 50 markers to over 100. We'll share more details on this higher multiplexing level at the upcoming AACR conference in April. Our commitment to speed and throughput capacity improvements is ongoing. We will release additional workflow and hardware improvements that continue to accelerate our phenocycler fusion workflow, driving the throughput from 10 samples to 30 samples per week. We will also be introducing new assay methods to further accelerate biomarker discovery and validation. The centerpiece is the launching of our new universal chemistry at the end of the year. This new assay is a best of breed between our current HyPlex Codex assay and our high throughput OPO assay. This universal chemistry will not only simplify the workflow, but will also importantly enable cohesion and consistency of antibodies and assay methodologies from high-plex biomarker discovery studies to then more focused high-throughput translational and clinical research programs. So biomarkers discovered on the phenocycler fusion can then be validated on the fusion alone and then advanced clinically to the HT or Polaris with the benefit of one consistent workflow and solution suite from ACOIA. This platform uniformity enabling both high-flex discovery and high-throughput validation on a consistent and cohesive platform from ACOYA is an important driver of our commercial success. It allows us to own the biomarker journey from the discovery to the clinic. Now, one final update on the phenocycler fusion system and the reagents is our commitment to providing a suite of solutions for RNA analysis and spatial transcriptomics. Now recall that the Phenocycler, again, it's an independent in-situ reagent delivery system, moving reagents on and off the tissue. It physically pairs and integrates with both our fusion or a third-party microscope. This modularity provides ACOIA with a distinct competitive advantage. We can develop and launch multiple assays and RNA solutions without requiring a new instrument or a new instrument redesign. We don't have a monolithic instrument where the hardware and assays are inextricably tied and fixed. It allows us to offer a suite of spatial transcriptomic solutions to meet a range of customer needs. Our first product launch for RNA analysis comes out of our recently announced partnership with Biotechni to automate their RNA scope chemistry on a phenocycler fusion system. RNAscope is the industry's most widely adopted solution for spatial RNA, with over 4,500 publications and thousands of customers. We expect to launch this middle of the year. RNAscope on our system will be used primarily for targeted applications and validation studies in the lower plex range. But simultaneously, for upstream broad-scale RNA discovery applications, We're also working on our own proprietary spatial transcriptomics technologies, which will enable up to a thousand PlexCavac capability. We expect to launch this proprietary spatial RNA solution in 2023, and we'll provide updates at the now rescheduled AGVD conference in June. So to summarize our new product initiatives, we have a powerful new instrument in the fusion. that when paired with a phenocycler, delivers unprecedented speed, capacity, and application breadth. We will raise the multiplexing on the protein side to 100 plus. We'll add additional validated content and provide workflow cohesion across our portfolio with our universal chemistry and also offer a range of RNA solutions. Further, this new instrument solution, the phenocycloid diffusion, allows our customers to run the fusion as a standalone system for high-throughput biomarker validation, making the phenocycloid fusion the industry's fastest, most powerful single-cell spatial biology system. So now as we look downstream to expand our opportunities and revenue in the translational and clinical markets, we have continued to invest in the PhenoImager HT platform, formerly the Polaris. Invested to enable robust clinical-grade throughput and to meet the necessary ISO and quality system certification requirements. In November of last year, our Advanced Biopharma Solutions Lab, or ABS in Marlborough, is where we perform lab services on the HT system, became CLIA certified. Again, this was last November. This certification enables ACOIA to support clinical trial enrollment studies and will drive the continued acceleration of our clinical trial partnerships with Key Biopharma. While we don't yet report our ABS revenues separately, we are seeing a real expansion of our pipeline of opportunities and book projects and expect ABS to increasingly contribute to our top-line growth. It's highlighting the growing adoption of the PhenoImager HT in clinical trials with both existing and new biopharma customers. Partnerships are central to our success in the translational market and in the clinical markets. We continue to leverage and advance our partnerships with thought leaders at Johns Hopkins, at UCSF, AstraZeneca, and many more. In December, we announced a new partnership with PathAI to combine our advanced biopharma solution service offering with their best-in-class AI-powered pathology. The combination of ABS with PATH-AI's capabilities and expertise in digital pathology will help streamline biomarker discovery and validation in identifying patients with a high likelihood of responding to immunotherapies. We expect this partnership to be a further growth driver of our ABS service business. So to summarize, Akoya has delivered on our strategic and financial goals for 2021. Our new phenocyclic fusion system will be a core platform for our customers, enabling high-plex, high-throughput, multi-ohmic spatial analysis across whole tissues at high resolution. Our growing reagent menu, increased throughput speed, and expanding install base will drive pull-through and reagent revenues. With our CLIA-certified ABS lab and our clinical-grade PhenoImager HT, we will continue to accelerate clinical advancements with partnerships across leading academic centers and biopharmaceutical companies. We are pleased with our strong financial performance in the fourth quarter and full year 2021 and will continue to expand on our leadership position in the spatial biology market as we move forward through 2022 and beyond. So with that, I'll turn the call over to Joe to discuss our financial results. Joe?

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