Biostem Technologies New

Thank you for standing by. My name is Rebecca and I will be your conference operator today. At this time, I would like to welcome everyone to the BioSTEM Technologies third quarter results webcast call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the call over to Adam Holdsworth, Managing Director of Investor Relations. Please go ahead.

Good afternoon, everyone, and thank you for joining our conference call to discuss BioSIM's third quarter 2024 financial results and corporate highlights. Leading the call today will be Jason Manashevsky, the company's founder 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 today may contain forward-looking statements based on the current expectations of management, which involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated. These risks are described in the company's funds with the over-the-counter market. We would caution not to place undue reliance on any forward-looking statements which speak only as of the date made and may change at any time. While we may update or revise these statements from time to time, the company undertakes no commitment to do so unless required by typical securities laws. This call also includes references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available in the company's press release on the Investor Relations section of BioSum's website. With that, I'm now pleased to turn the call over to Jason Manischewski.

Thank you, Adam, and thank you all for joining us today. I'm pleased to report that BioSum Technologies has achieved another milestone, marking our third consecutive quarter of record-setting growth. In Q3 of 2024, we posted revenue of $82.6 million, adjusted EBITDA of $9.9 million, and our cash position improved to $14.6 million, establishing a new revenue high for the company and demonstrating our robust financial performance. For the first nine months of this year, we've generated $199 million in net revenue, highlighting our continued momentum and resilience in the market. Our success this quarter is a testament to the strength of our portfolio of skin substitutes, especially our annual REV2 allograft. powered by our patented bioretain technology. This innovative technology is driving strong commercial performance across a wide range of non-acute segments. Our gross margin remains solid at 95%, reflecting our commitment to operational excellence and the efficiency of our manufacturing processes. I want to take this moment to recognize the dedication of the entire BioSTEM team, your commitment to our vision, and the honor you bring to the gift of donation are what drives these outstanding results. As part of our efforts to ensure patient access to high-quality, life-changing products, we've been actively engaging with CMS, congressional leaders, and industry partners to advocate for fair and effective Medicare reimbursement policies. We recognize that certain players have caused overutilization within the Medicare reimbursement system, impacting policy and patient access. Our goal is to help shape a reimbursement landscape that not only supports ethical practices, but also ensures that millions of Medicare beneficiaries have access to vital treatments. I also remain at the forefront of this conversation, collaborating with government and industry leaders to support responsible, patient-centered policy solutions. Turning to partnerships, I'd like to extend my gratitude to our commercialization partner, Venture Medical. Their role has been instrumental in our growth journey. as they led the nationwide launch of MNRF2 in Q4 of 2023 and are now preparing for Vendage AC's launch in Q4 of 2024. Venture Medical is a key commercialization and marketing partner, and we're thrilled to work side by side with them once again with Vendage AC, which recently had a national ASP published for Q4 of 2024, allowing reimbursement across all MAP regions. Early in the quarter, we received IRB approval for two major clinical studies on non-healing diabetic foot ulcers. These approvals are essential milestones in our clinical journey and support our commitment to rigorous, impactful research. We recently enrolled our first patients in two randomized controlled clinical trials this quarter, evaluating our bioretained allografts. We anticipated an early readout of these results from these studies by mid-2025 and final results in early 2026. providing us with clinical data that will strengthen our clinical approach, broaden our payer coverage base, and support expanded access to our innovative products. Additionally, we're in the final stages of designing a study protocol for venous leg ulcers with timelines to be communicated once finalized. We recently reported positive results from a retrospective data study comparing our bioretained allografts to the standard of care for diabetic foot ulcers. underscoring our commitment to advancing clinical data on our products. In October, these findings were published in the International Moon Journal, providing valuable peer review validation of our technology's effectiveness. This achievement further reinforces BioSIM's standing as a leader in research-backed innovation. In support of our equity capital market strategy, we filed our Form 10 on September 27th with the SEC and submitted an application for uplisting to NASDAQ at the same time. We are currently working through our initial SEC review comments and expect to submit a formal response in Q4, along with an amended Form 10. Uplisting to a national exchange and becoming fully reporting with the SEC is a strategic commitment to enhance BioSTEM's visibility and provide wider accessibility to a broader investor base. As we look to the remainder of 2024 and beyond, BioSTEM is well positioned for continued growth and innovation. Despite industry challenges, our strong foundation, evidenced by our robust portfolio and effective partnerships, positions us to adapt and grow. We are confident that our strategic initiatives, groundbreaking products, and dedicated team provide a solid foundation for future success. Looking ahead, we are optimistic about our upcoming clinical trial results and the potential for broadening our market access, which could provide further clinical validation of our products, superiority and drive broader payer coverage and adoption of BioSense allografts. These initiatives have the potential to diversify and expand our product offerings, positioning us on a strong trajectory to deliver value for our shareholders, expand our market presence, and improve patient outcomes with our innovative solutions. Thank you to our shareholders, Venture Medical, and our team members for their ongoing trust, dedication, and support as we work to bring transformative solutions across the continuum of care to patients and providers. With that, I'll now hand the call over to Mike Fortunato, who will provide a detailed review of our financial results for Q3 2024.