Perimeter Medical Imaging AI (ticker: PINK) reported its first quarter 2024 results, highlighting significant advancements in its clinical development and commercial efforts. CEO Adrian Mendes expressed confidence in the company's strategy and pace, particularly noting the progress of its pivotal trial led by Dr. Alastair Thompson at Baylor College of Medicine.
The trial, which is evaluating the effectiveness of Perimeter's B-Series OCT with proprietary ImgAssist AI in breast lumpectomy procedures, has seen accelerated patient enrollment, allowing the company to anticipate full enrollment by early Q4 2024. On the commercial front, Perimeter has successfully placed its S-Series OCT in three new hospitals, expanding its user base. CFO Sara Brien reported a strong financial position with USD 10.6 million in cash and equivalents as of March 31, 2024.
Key Takeaways
- Perimeter's pivotal clinical trial for B-Series OCT with ImgAssist AI is advancing with accelerated patient enrollment.
- Full enrollment for the trial is expected by early Q4 2024, bypassing interim analysis to maintain momentum and study integrity.
- Three new S-Series OCT systems have been placed in hospitals, indicating growing market recognition and adoption.
- The company's financial position remains solid with USD 10.6 million in cash and equivalents.
- Forward-looking statements were made regarding Perimeter's strategic goals, commercial activities, and market expansion.
Company Outlook
- Perimeter aims for a full commercial launch of its AI-enabled OCT technology following positive trial results.
- The company is focused on broadening its user base and leveraging word-of-mouth recommendations to expand into new networks and geographies.
Bearish Highlights
- The company acknowledges numerous risks and uncertainties that could affect projected outcomes.
Bullish Highlights
- Perimeter's B-Series OCT has received FDA breakthrough device designation, potentially expediting the path to market.
- The company's S-Series OCT is gaining traction, with new placements and positive surgeon feedback.
Misses
- No specific financial misses were discussed in the call; however, the company's forward-looking statements come with the usual risks and uncertainties.
Q&A Highlights
- The Q&A session focused on clarifying the company's progress and financial health.
Perimeter Medical Imaging AI is making strides in its mission to improve surgical outcomes and reduce the need for reoperations in breast cancer surgery. With key clinical trials progressing and new commercial placements, the company looks to a promising future, pending regulatory approvals and continued market adoption.
InvestingPro Insights
Perimeter Medical Imaging AI's (ticker: PYNKF) first quarter 2024 results demonstrate a company on the move, with clinical and commercial milestones that investors should watch closely. Here are some InvestingPro Insights to give you a deeper understanding of the company's current financial health and market performance:
- With a market cap of approximately $27.68 million, Perimeter Medical Imaging AI is a small-cap company that could offer growth potential, especially as it advances in its clinical trials and commercial efforts.
- The company's gross profit margin for the last twelve months as of Q4 2023 stands at an impressive 91.63%, indicating a strong ability to control costs relative to its revenue - a positive sign for potential investors.
- Despite these strong margins, the company has a negative P/E ratio of -1.97, which suggests that investors are expecting future growth or that the company has had recent losses.
InvestingPro Tips for PYNKF highlight the company's solid cash position and gross profit margins, which are encouraging signs for its financial stability. On the other hand, the company is not expected to be profitable this year and has experienced a significant price drop over the last year. These tips can be crucial for investors trying to gauge the risk and opportunity associated with Perimeter Medical Imaging AI:
1. Perimeter holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about the company's financial resilience.
2. The company's stock has seen a significant return over the last week, which could indicate a turning point or a positive reaction to recent company developments.
For those looking to dive deeper into Perimeter Medical Imaging AI's performance and future prospects, there are additional InvestingPro Tips available. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With this subscription, you will gain access to a total of 12 InvestingPro Tips that could further inform your investment decisions.
Full transcript - Perimeter Medical Imaging AI (PYNKF) Q1 2024:
Operator: Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical Q1 2024 Conference Call. [Operator Instructions]. This call is being recorded on Tuesday, May 14, 2024. I would now like to turn the conference over to Sara Brien, Chief Financial Officer. Please go ahead.
Sara Brien: Good afternoon. Thank you for joining us on this call and webcast to provide the first quarter 2024 results for Perimeter Medical Imaging AI or perimeter. Joining me on today's call is Adrian Mendes, Perimeter's Chief Executive Officer, who will provide an overview of Perimeters progress against the business; and Andrew Berkeley, Perimeter's, Chief Innovation Officer, who is available to answer questions when we open up the call for Q&A after our prepared remarks. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements regarding the future financial position, business strategy and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes. The potential benefits of our products, including Perimeter's S-Series OCT, Perimeter's B-Series OCT, and Perimeter's image assist. The expected benefits of Perimeter's updated version of its ImgAssist AI, Perimeter's ability to broaden its user base and the expected approval of its proprietary AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEDAR filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward-looking statements. For additional information about the risks and uncertainties facing our business, management encourages you to review the company's public filings and press releases, which are posted on sedarplus.ca The news release summarizing this quarterly update we made available under the Investors section of our website at perimetermed.com and filed with SEDAR. Now, I'd like to turn the call over to Adrian.
Adrian Mendes: Thanks, Sara, and good afternoon, everyone. On behalf of the management team and everyone at perimeter, I would like to thank you for your interest in our company. And for those of you who are shareholders, we appreciate your support. I'm particularly excited today because we're starting to see tangible results from the changes we've made over the past 12 months, and I look forward to sharing some of them with you today. Since joining the Perimeter leadership team, we have implemented a strategy to greatly increase our pace of execution across all aspects of the business. And although it's been less than a couple of months since we reported our year end '23 results, we have made significant advancements within our clinical development, commercial, and new product innovation teams. Today, I will provide an update on our progress in these key areas. One key area of focus is our ongoing pivotal trial, led by principal investigator, Dr. Alastair Thompson at Baylor College of Medicine, Dr. Alastair Thompson at Baylor College of Medicine is conducting a multicenter randomized two arm clinical trial to measure the effectiveness of the Dr. Alastair Thompson at Baylor College of Medicine B-Series OCT, with our proprietary ImgAssist AI, in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard inter operative margin assessments. Shortly after I joined the company, Perimeter reached alignment with the FDA on key elements of the ongoing clinical trial, including clearance to introduce an enhanced AI algorithm, the option to introduce an interim analysis within the study protocol, and permission to enroll additional subjects, in order to achieve statistically significant findings, based on the use of the new AI algorithm. Subsequently, the new algorithm was introduced into the study, which includes our latest AI advancements that have demonstrated improved sensitivity, specificity, precision, and recall. We believe that this updated version of ImgAssist AI will contribute to more accurate classifications, as well as fewer false positives and negatives. Further, all sites have been activated, which has contributed to accelerated enrollment in the study. Our goal to reach sufficient enrollment by the second quarter of this year in order to make a go, no-go decision around conducting an interim analysis in the study. I'm very pleased to report that we are enrolling patients at a much higher rate than modeled. And as such, we've opted to forego the interim analysis, pending regulatory approval and focus our efforts on expediting full enrollment of the study now anticipate in early Q4. This decision allows us to build upon the enrollment momentum, maintain the study blind, and gather as much data as possible based on the use of the improved algorithm. Further, we don't need to split the attention of the clinical team, but rather, can drive forward to enroll all patients by early Q4 in order to generate top line results. We have a high degree of confidence that this pathway not only allows for the strongest data package for regulatory submissions to support potential commercial approval but is also the most capital and resource efficient option. Having already received FDA breakthrough device designation for our B-Series system, the readout from this pivotal trial will be a significant catalyst for Perimeter. If positive, these data will support a full commercial launch of our AI-enabled OCT technology, representing the next major step in our go-to-market strategy and an opportunity to significantly broaden our user base across the US. Turning now to the to the commercial side of the business and our goal to seed the market with S-Series OCT, in order to create a network of early adopters prior to B-Series approval. To set the stage, the S-Series OCT system represents our flagship interoperative imaging technology, which provides surgeons with image resolutions capable of visualizing tissue structures at the cellular level down to the critical two millimeter depth when assessing margins real time in the operating room. We continue to implement key process improvements and make important investments in our sales organization. In particular, we identified that we needed to augment our clinical education and image training team and redeploy resources to help eliminate bottlenecks in our sales cycle. This work is starting to pay off. In fact, since the beginning of this year, we've successfully closed three new placements of our S-Series OCT, including two new hospitals in North Texas, which are part of a leading national healthcare network, this is a current repeat customer; and a third, which is the first placement in a brand new health care network. This expansion is exciting for us because it shows that search and word of mouth is starting to spread through the broader community, which is key to our scaling goals. The pace of new placements far exceeds that of last year and is reflecting the growing recognition of the need for much better solutions to address the large number of reoperations after breast conserving surgery. As a reminder, this past quarter, researchers at the University of Texas MD Anderson Cancer Center published a study that demonstrated high reoperation rates after breast conserving surgery persists and are correlated with elevated risks and adverse outcomes for patients, concluding that more attention and continued effort should be made to reduce operation rates. I encourage you to read this research. It outlines the real problem that the entire Perimeter team is striving to address, and clearly highlights the clinical value proposition of our technology, which we can deliver to our customers. I had the privilege of meeting a number of surgeons while attending the annual meeting of the American Society of Breast Surgeons or ASBRS this year, and saw firsthand the keen interest to use a technology that can help them identify cancer margins real time in the OR. While at our booth, I saw current customers interacting with surgeons new to S-Series OCT and also fulfilling to see these aha moments about how our technology can solve this real unmet need. We will continue to work on shortening the sales cycle for those placements and be sure to capitalize an increasing number of word-of-mouth recommendations from the surgeons to their colleagues, both within their broader health network as well as beyond and into new networks and geographies. These recommendations from early expert adopters to their peers provide additional validation and support our aim to make Perimeter's technology part of the standard of care in cancer surgery. Finally, we have put additional focus on gathering customer feedback, in order to apply an agile approach to improving, not just our current product offering, but the other products and technology within our development pipeline. On that note, while our near-term focus is on the S-Series and B-Series, we have a robust product pipeline supported by our engineering team and dedicated AI experts who are always looking at ways to improve our product offering across both health care workflows and across various indications. Looking particular at our AI work, in addition to the many improvements the algorithm itself, Perimeter has a massive, very large proprietary image library, not just in breast cancer, but across other tissue types. With this data set, we can train models in a way that will be very difficult for other companies to replicate. This is the world that I come from and was one of the key things that made me so excited about joining Perimeter. We have world-class leadership on our Board and strong relationships with expert surgeons who are helping us train the AI. We have identified many ways that AI can improve our business offering. While the obvious advantage is using AI for image recognition or what we call image assist for the surgeon, we are also looking at ways to speed up image capture, improve the clarity of images, and other improvements up and down our technology stack. I believe that Perimeter's a leadership represents a key value driver as we build a product pipeline that aims to improve surgical outcomes, and also broaden our addressable market through a variety of tissue types. Under Andrew's leadership, we've been taking a very disciplined approach to our product development roadmaps, and we will continue to leverage our extensive AI and medtech expertise to find ways to deploy a model through our tech stack to improve the customer experience in many different ways. We will be sharing some of these advanced with you as we roll out over the course of this year. I'd like to now turn the call over to Sara who will summarize our financial position before opening up the call for your questions. Sara?
Sara Brien: Thanks, Adrian. Turning briefly to our financial position, as of March 31, 2024, cash and cash equivalents were approximately USD10.6 million. All of our current clinical and product development plans remain on track and within our current financial modeling. For more details, I encourage you to refer to the quarterly report and the press release filed today. Thanks again for your time and attention today. Everyone at Perimeter is committed to making a real difference in the lives of patients by creating and commercializing innovative, interoperative imaging technologies, with the aim of helping ensure that no patient has to go through the emotional and physical trauma of the second surgery due to cancer left behind. We look forward to keeping you updated on our progress through 2024 and are excited about the important milestones that lie ahead. With that, I will now open up the call for your questions. Operator?.
Operator:
Sara Brien: Thank you everyone for joining today. We look forward to keeping you up to date on milestones in our next earnings call. Thank you.
Operator: Ladies and Ladies and gentlemen, this concludes conference call for today. We thank you for participating and ask that you please disconnect your lines.
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