5/12/2025

speaker
Operator
Conference Operator

I would now like to turn the call over to Adam Holdsworth, Director of Investor Relations. Please go ahead.

speaker
Adam Holdsworth
Director of Investor Relations

Good afternoon, everyone, and thank you for joining our conference call to discuss Biostem Technologies' first quarter 2025 financial results and corporate highlights. Leading the call today will be Jason Monteshevsky, the company's Chairman and Chief Executive Officer, and Mike Fortunato, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that our remarks may contain forward-looking statements based on management's current expectations. These involve inherent risks and uncertainties that could cause the actual results to differ materially from those indicated. These risks are described in our filings with the OTC markets and with the SEC. Your caution not to place undue reliance on forward-looking statements would speak only as of the date made. The company undertakes no obligation to update them unless required by law. Additionally, as discussed in our Q4 2024 earnings call, we are undergoing an SEC review process related to our planned uplisting to NASDAQ. Today's financial results are preliminary and unaudited, and final results may change, perhaps materially, pending the completion of our financial statement audit, which is predicated on the resolution of SEC comments related to their review of our Form 10. Q4 2024 earnings call. We discussed the potential changes to our financial results and particularly revenues as a result of the resolution of SEC comments. Please refer to our prior comments as they continue to apply to our first quarter 2025 results discussed today. Finally, this call also includes references to non-GAAP financial measures. A reconciliation to comparable GAAP measures can be found in our earnings press release posted on the investor relations section of BioSense website. With that, I'd now like to turn the call over to Jason Monticelli. Jason?

speaker
Jason Monteshevsky
Chairman and Chief Executive Officer

Thank you, Adam, and thank you all for joining us. Before we get into our prepared remarks, I want to take a moment to revisit an important topic that we discussed in more detail on our fourth quarter call. A full transcript of that call is available on our investor relations section of our website. And as a reminder, we are engaged in an ongoing accounting review related to our distribution agreement with Venture Medical. This includes active dialogue with our auditors and the SEC, specifically around the treatment of bona fide service fees paid to venture. While we do not believe this impacts the fundamentals of our business or the underlying economics, it could affect how we have presented top line revenue in the past and how we may present it going forward. That said, we do not expect any material changes to net income, adjusted EBITDA, or EPS as a result of these discussions or the SEC review process. We are working diligently with our legal and accounting advisors to bring this matter to resolution and remain confident in the strength of our business. We appreciate your patience as we complete this important step to ensure our form 10 is accurate and aligned with all applicable guidance. Now, I'm pleased to report that BioSIM delivered the strongest first quarter revenue in our company's history, with revenue increasing 73% year over year to $72.5 million, marking our fifth consecutive quarter of profitability. We reported gap net income of $4.5 million, or $0.27 per share, and an adjusted EBITDA of $7.8 million. Importantly, we ended the quarter with $26.7 million in cash, which is an increase from $22.8 million in Q4. Our commercial performance was driven by the ongoing momentum of our flagship products. Vendahe AC continues to roll out nationally through our partnership with Venture Medical, and we are seeing meaningful adoption as that product gains traction with our customers in the private offices. including mobile, long-term care, and skilled nursing types of service. We continue to see growing clinical and commercial demand for our products powered by BioRetain, driven by the differentiation of that technology and its performance for our customers. While we are pleased with our strong year-over-year growth in the first quarter, it's important to acknowledge the impact of the LCD. Although the implementation of the LCD was delayed until January of 2026, the uncertainty that persisted during the quarter created headwinds across the chronic wound care market and impacted our sequential quarterly growth. Despite this challenge, our results clearly demonstrate BioStim's ability to execute and outperform industry trends. Our growing customer base, strong clinical value prop, and proactive commercial strategies enable BioStim to maintain positive momentum. From an operational perspective, we are prioritizing the transition of customers from MDRF2 to Vendahe AC to drive brand consistency within the Vendahe product family. This strategy is expected to reduce SG&A costs as Vendahe AC does not carry licensing fees and will ultimately improve profitability as we scale the business. With regard to revenue, we're focused on four core tactics to accelerate growth in the year ahead. First, Venture Medical continues to scale its commercial footprint. With more than 150 sales representatives already operating nationwide, they're aggressively expanding into new geographies, both by adding 1099 reps in uncovered territories and by building a 40-person direct sales team to deepen coverage. Second, we're seeing strong and expanded adoption of OneView, Venture's proprietary practice management platform. OneView is designed to streamline the entire wound care process, everything from patient insurance verification and clinical documentation to inventory management, reimbursement, and post-treatment tracking. It's become a key differentiator for venture, enabling providers to reduce administrative burden and focus more on patient care. We're also enhancing OneView with new features that further automate workflow and provide integrated clinical and operational insights. These investments are not just about efficiency. They're about strengthening long-term customer loyalty, improving net promoter scores, and ultimately increasing customer lifetime value. Third, we're expanding sales efforts along the eastern seaboard, where we see strong provider density and favorable market dynamics. This initiative is tightly integrated with OneView, which continues to be a force multiplier for field teams, simplifying documentation, improving claim velocity, and driving revenue capture. And fourth, we're actively evaluating acquisition opportunities to diversify our product portfolio and expand our reach across the advanced wound care continuum. We believe strategic M&A can unlock new revenue channels strengthen our commercial infrastructure, and increase shareholder value. On the clinical trial front, we continue to make solid progress across our randomized controlled trials, with improved patient enrollment across all three active programs. In Q1, we received Institutional Review Board approval, or IRB, to initiate a new clinical trial evaluating bioretained amniocortisone, or BRAC, or venous leg ulcers. This marks our third prospective randomized clinical trial, which underscores our commitment to generating high-quality evidence that will commercially support our products and demonstrate superior patient outcomes. These trials continue to advance according to plan, with initial data readouts from our first trial anticipated by mid to late 2025 and final results expected in early 2026. In addition to these randomized clinical trials, we are actively exploring partnering with Venture Medical on their Project Barrel program. which is a large-scale patient registry being designed to collect real-world data on the use of our products for the treatment of patients with a variety of chronic wound indications. Further strengthening our patent portfolio, we were issued notice of allowance for two new patent applications in Q1. Our intellectual property portfolio now includes 55 issued and 52 pending patents, providing protection for our proprietary technology and ensuring a sustainable competitive advantage in placenta-derived technologies. Finally, on the capital markets front, we continue to make progress toward our planned uplifting to NASDAQ. We remain in active discussions with the SEC regarding our Form 10 registration. While this process takes time, we believe our submission was well positioned for approval once all comments are resolved. Achieving a NASDAQ listing is a major milestone for BioSIM and will help broaden our shareholder base, increase liquidity, and enhance our visibility within the investment community. Overall, we are extremely pleased with our Q1 performance and believe Biosec is well positioned for continued success as we advance through 2025. With that, I'll turn the call over to Mike Fortunato for a more detailed review of our financial results.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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