8/5/2024

speaker
Operator

Good day and thank you for standing by. Welcome to the Akoya Biosciences second quarter 2024 earnings 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'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference 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's joining us today on this call. I'm Priyam Shah, Head of Investor Relations at Akoya Biosciences. On the call today, we have Brian McCalligan, Chief Executive Officer, and Johnny Eck, Chief Financial Officer. Earlier today, ACOIA released financial results for the second quarter, ended June 30th, 2024. 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, or 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 a COIS business, please refer to the risks identified in our filings with the U.S. Securities and Exchange Commission, including in the risk factors section of our annual report on Form 10-K for the year ended December 31, 2023, filed on March 5, 2024, and 10-Q filed today, August 5, 2024. We urge you to consider these factors, and you should be aware that these statements are 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, August 5, 2024. 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. The earlier portion of this call will be archived on the Investors section of our website later today under the heading Events. Lastly, ACOIA will be participating in the upcoming Canaccord Genuity Growth Conference and the Morgan Stanley Healthcare Conference, and we hope to see many of you there. And with that, I will turn the call over to Brian.

speaker
Brian McCalligan
Chief Executive Officer

Thank you, Priyam, and good afternoon or evening to everyone. We appreciate you joining us today. During today's conference call, I will provide an overview of our performance in the second quarter, highlight our business and operational advancements, as well as strategic decisions aimed at positioning our company for long-term growth. Following that, Johnny will delve into our financials, key trends, and our outlook for the future. We are pleased to report revenue of $23.2 million in the second quarter, a 26% sequential increase from the $18.4 million in the first quarter, and stable year-over-year performance. Our new manufacturing center of excellence in Marlborough, Massachusetts is now fully operational and was a key contributor to the rebound this quarter in both the reagent volumes and instrument placements. In line with our objectives for the quarter, We were pleased with our ability to deliver strong sequential growth across all revenue categories, especially on instruments. Instrument revenue reached $8.3 million, reflecting a 70% sequential revenue growth, with 51 instruments placed in the second quarter versus 30 instruments in the first quarter, a robust rebound and trajectory. Reagent revenue totaled $7.4 million, a 27% increase from the prior year, and sequential growth above the $7 million we reported in the first quarter. We now have a total install base of 1,264 instruments, the largest in the industry, and a fully available catalog of molecular barcoded antibodies and accompanying reagents manufactured internally. Service and other revenue totaled $7.2 million for the second quarter, an increase of approximately 14% over the prior year period, and 17% sequential growth over the first quarter. A vital objective for Akoya in 2024 is to optimize our operating efficiency and deliver operating cash flow breakeven by the end of the year. In the first half of this year, we completed several strategic initiatives to support our efforts to achieve this goal. First, as noted earlier, our manufacturing center of excellence is now fully operational and has enabled a near complete overhaul and refresh of our entire molecular barcoded antibody catalog. We not only resolved the reagent availability challenges faced earlier in the year, but also now have robust reagent development and manufacturing capabilities. Our focus will now turn to continued process optimization, catalog expansion, and reagent gross margin improvements. Next, we completed comprehensive reorganization efforts to optimize and align our teams with our corporate objectives. This included two restructurings, one in January and a second more recent one in July. In aggregate, we implemented a workforce reduction of approximately 35% compared to end of year 2023. In parallel, This allowed us to consolidate our functions from four facilities to two core facilities in Marlboro and included the closing of our Menlo Park, California offices and labs. We believe we now have the disciplined P&L necessary to support our financial goals, return to meaningful growth by the end of 2024, capitalize on the emerging and exciting clinical opportunities and deliver sustaining value to our shareholders. Shifting focus, let's review our product portfolio. The Phenocycler Fusion, or PCF, now with 236 combined units in the field, is the top-selling spatial proteomics platform for the discovery and translational markets. It features a unique two-in-one system, supporting scalable molecular barcoding for high-plex tissue analysis of up to 100 plex, while in parallel, enabling high throughput low to mid-plex studies using off-the-shelf third-party antibodies with our gold standard opal chemistry. The phenol imager HT, or HT, of which we now have 368 in the field, is the only clinical-grade spatial platform on the market actively being used in biopharma prospective clinical trials. The HT has three core attributes that make it stand alone in the clinical market. First, It has proven technical robustness, sensitivity, and reproducibility for multiplex immunofluorescence at an unmatched throughput of greater than 300 samples per week. Second, it has been developed under ISO and full design control and deployed in a clear setting. And finally, with our partners at Acrobon, it is on a potential path to achieve U.S. regulatory approval. having been granted breakthrough device designation by the FDA for the Acrovan ACR368 oncocignature assay, coupled to fast-track designation for their ACR368 therapy. We believe our pharma partners see these attributes as confirmation of the HT as a viable clinical platform and as clear evidence of ACOIA's expertise and organizational capabilities to deliver on and support a companion diagnostic. The annualized pull-through is now in the low to mid $50,000 range for the PCF and high $30,000 range for the HT. We expect this to increase along with our install base. We continue to direct our content and application development efforts to not only address the significant market opportunities in oncology and inflammatory disease, but with our manufacturing now up and running, we are poised to accelerate our efforts into additional like neurobiology and preclinical drug development. We also continue to lead the market in publication volume, reaching a total of 1,450 publications citing ACOYA's technology as of the second quarter, a 47% increase from the prior year. This growing number of publications underscores the broad utility and trust researchers have in our platforms. ACOYA's comprehensive product portfolio supports the continuum from high-plex discovery to routine clinical diagnostics. According to the 2024 DESEBIO Spatial Biology Market Research Report, proteomic phenotyping using multiplex immunofluorescence will be the key driver of spatial biology market growth over the next five years. DESEBIO specifically identified Akoya as the leading provider with products ideally suited for clinical trial support and spearheading Commercialization of Spatial Proteomic Companion Diagnostics. On our first core earnings call, we announced several significant late-stage clinical development updates and have a strong momentum in this emerging business segment. These included, as noted earlier, a biopharma partner, Acrobon's, promising phase two clinical trial progress using the ACR368 OncoSignature assay deployed on our HD platform. to identify ovarian and endometrial cancer patients who may benefit from their ACR368 therapy. We also announced an exclusive partnership with NeraCare to enable personalized therapy selection for early stage melanoma. Their ImmunoPrint assay has demonstrated robust clinical performance in identifying early stage melanoma patients at high risk of relapse through multiple independent prospective, and retrospective clinical studies. The data demonstrates that the immunoprint high-risk patient group is ideally suited to potentially benefit from the therapeutic options that would usually only be administered in later stages. We believe that this would represent a significant expansion of the TAM for current melanoma therapies. Immunoprint had a strong presence at this year's American Society of Clinical Oncology meeting, and we are making significant progress in our pharma partnership discussions. And finally, we announced the NMPA approval of the HT instrument in China, enabling its integration into clinical workflows across hospitals throughout China. Over the last year, within our advanced biopharma solutions CLIA lab, we have also seen the rapid transition of our CLIA lab services migrating from project-based translational work to now predominantly higher value, longer term clinical trial studies, making up approximately 90% of the ongoing programs. The rapidly increasing use of multiplex immunofluorescence across early and late stage drug and diagnostic assay development signal that the clinical trial market is approaching quickly and has the potential to fundamentally transform the spatial biology landscape. We believe ACOIA has the only true clinical-grade spatial platform with the HT, affording us a significant head start and leadership position in the clinical markets. In closing, we are pleased with our commercial rebound in the second quarter and the progress of our clinical programs. Given market conditions, our first half finish and operating efficiency gains, we believe we're well positioned to achieve our second half financial objectives and exit the year with a return to top line growth while meeting our goal of operating cash flow break even. And with that, I will now turn the call over to Johnny to discuss this in more detail. Johnny?

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