Vericel Corporation

Ladies and gentlemen, thank you for standing by. Welcome to VeriCell's first quarter 2022 conference call. At this time, all participants are in a listen-only mode. I would also like to remind you that this call is being recorded for replay. I will now turn the conference call over to Eric Burns, VeriCell's head of financial planning and analysis and investor relations.

Thank you, operator, and good morning, everyone. Welcome to Verasol's first quarter 2022 conference call to discuss our financial results and business highlights. Before we begin, let me remind you on today's call, we'll be making forward-looking statements covering the private securities litigation reform act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and describe more fully in our findings of the SEC. In addition, all forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Please note that a copy of our financial results press release and a short presentation with highlights from today's call are available on our website. I'm joined on this call by Veriself's President and Chief Executive Officer, Nick Colangelo, and our Chief Financial Officer, Joe Marra. I will now turn the call over to Nick.

Thank you, Eric, and good morning, everyone. I'll begin today's call by discussing financial and business highlights for the first quarter and our expectations for the rest of the year, and then turn the call over to Joe for a more detailed review of our first quarter financial performance and guidance for 2022 before opening the call to Q&A. Overall, we're very pleased with our financial and operational performance to start the year across both our sports medicine and burn care franchises, despite the continued impact of COVID-19, particularly in the first half of the quarter. The company remains on track to deliver another year of significant revenue growth, margin expansion, and operating cash flow, and as such, we're reaffirming our full-year financial guidance. We also continue to make significant progress on key regulatory and clinical programs for both franchises, and importantly, We remain on track for the planned mid-year resubmission of the Nexabrig BLA. From a financial perspective, we generated total net revenue of approximately $36 million for the first quarter, which represents 7% total product revenue growth for Macy and EpiCell compared to the first quarter of 2021. We also maintained our strong profitability profile, as we generated positive adjusted EBITDA and operating cash flow for the seventh consecutive quarter. From a commercial perspective, Macy revenue of $26 million came in above our first quarter guidance, increasing 9% compared to the first quarter of 2021. Importantly, Macy significantly outperformed the overall cartilage repair procedure market, which we estimate, based on market data, declined by double digits over the same period. In addition, we generated double-digit growth in surgeons taking MACE biopsies compared to the first quarter of 2021 and generated the second highest monthly biopsy volume in March since the launch of MACE. We expect that as the overall healthcare environment and MACE patient behavior trends continue to normalize over the remainder of the year, These strong MESI fundamentals will lead to a significant acceleration in growth during the second half of the year. And as such, we're reaffirming MESI revenue guidance for the full year. EPICEL revenue of approximately $10 million was in line with our recent higher run rate and represents the sixth consecutive quarter of revenue greater than $9.5 million. The growth drivers for EPICEL also remain very strong. as we had over 20% growth in burn centers treating patients and taking epi-cell biopsies compared to last year, and a record monthly high for epi-cell biopsies in March. From an operational perspective, as we announced this morning, we expanded our commercial leadership team with the appointment of Mike Gilligan as our vice president of Macy National Cells. Mike, who will report to Roland DeAngelis, our head of commercial operations, joins VeriCell with more than 15 years of commercial experience in the medtech and pharmaceutical industries. Prior to joining VeriCell, Mike served as U.S. Vice President of Sales for Biologics and Commercial Initiatives at Smith & Nephew. Prior to Smith & Nephew, Mike held sales leadership and marketing roles at Stryker after beginning his career at Pfizer. Mike brings extensive sales experience in the sports medicine field, outstanding leadership skills, and strong business acumen to our high-performing Macy team as we continue to focus on our key growth drivers of adding new surgeons, achieving deeper practice penetration, and increasing biopsy conversion rates. We're excited to have Mike join the Veriself team, and I'm confident that he'll play an integral role in bringing the benefits of Macy to even more surgeons and patients as we continue to drive strong growth for Macy in the years ahead. Turning to our pipeline, we have several exciting milestones ahead for the balance of the year. We remain on track for a mid-year resubmission of the NexaBridge BLA, which would position the product for a potential commercial launch in the first half of 2023. Based on the strong leadership and track record of execution by our commercial and medical burn care teams, we're well positioned for a successful launch of this important product which we believe upon approval has the potential to change the standard of care for eschar removal for patients with severe thermal burns. We also continue to advance important lifecycle management initiatives for MACEI and remain on track for planned discussions with the FDA later this year to review both our MACEI arthroscopic and ankle indication development programs, initiatives that we believe will support continued strong growth in the years ahead. Finally, we're pleased to have announced plans during the first quarter for a new state-of-the-art advanced cell therapy manufacturing and corporate headquarters facility. The new facility, which broke ground last month and is expected to begin commercial manufacturing in 2025, will significantly increase our manufacturing capacity and demonstrates our confidence in the continued growth trajectory of Macy and EpiCell in the years ahead. In summary, The company had a strong start to the year. Our expectations for another year of significant growth for both Macy and Episod remain on track, and we continue to make progress on important regulatory and clinical programs for both of our franchises. I'll now turn the call over to Joe to discuss our first quarter financial results.