ADMA Biologics Inc

At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss Admin Biologics' financial results for the third quarter of 2025 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer, and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brad will provide an overview of the company's third quarter 2025 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the third quarter 2025 financial results and summarized certain achievements in recent corporate updates. The release is available on our website at www.admobiologics.com. Before we begin our formal comments, I'll remind you that we will be making forward-looking assertions during today's call that represent the company's intentions, expectations, or beliefs concerning future events, which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks, and uncertainties, such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements, except as required by federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today, in the risk factors section in our SEC filings, in our quarterly report on Form 10-Q for the quarter ended September 30th, 2025, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that the discussion on today's call includes certain non-GAAP financial measures, including adjusted EBITDA and adjusted net income. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

Good afternoon, everyone. ADMA delivered another record quarter of sequential and year-over-year growth, underscoring the strength of our business model and disciplined execution. We delivered total revenue of $134.2 million, representing a 10% quarter-over-quarter increase and 12% growth year-over-year. GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year. and adjusted EBITDA grew to $58.7 million, representing 16% quarter-over-quarter growth and a 29% increase year-over-year. These results demonstrate the durability of our growth engine and the expanding leverage in our fully integrated U.S. domicile business model. Our performance continues to be led by Ascentive. Our differentiated and patent-protected specialty IG exclusively targeting complex immunodeficient patients. Ascentive delivered record utilization this quarter, driven by strong prescriber adoption and sustained patient demand. 2026 payer negotiations are progressing positively and are expected to further expand coverage, improving access and accelerating growth. For select payers where restrictions previously existed, we anticipate improved Ascentive reimbursement access beginning next year. Equally important, a retrospective cohort analysis and an investigator-initiated study of primary immunodeficiency patients demonstrated statistically significant reduction in infection rates following transition from standard immune globulin therapy to Ascentis. Patients experienced 2.1 infections per year while receiving prior lines of standard Ig therapy, compared with 0.9 infections per year on Ascentis. representing a reduction of greater than 50% with a p-value considerably inside of 0.05. These findings suggest that Ascendant provides enhanced protection against infections in real-world clinical practice. Data validation and extended analyses are ongoing. ADMA plans to submit these results for peer-reviewed publication in the near term, with additional findings planned to be submitted at the Clinical Immunology Society 2026 Annual Meeting. Operationally, the FDA's lot release of our first yield-enhanced production batches represents a major inflection point. This process innovation is expected to improve per batch output by 20% or more, driving sustained gross margin expansion beginning in the fourth quarter of 2025 and continuing through 2026 and beyond. Regulatory release of these batches was achieved in the ordinary course, positioning us to realize our first full year of yield enhancement production in the entirety of 2026. In addition to strengthening our commercial operating model, we continue to invest in innovation and pipeline advancement. Our SG001 program is progressing as planned, and we recently submitted a CNPV voucher application to the FDA. If approved, this voucher could meaningfully accelerate further regulatory review timelines, giving us a clear advantage as we move into registrational clinical development. SG-001 remains a meaningful long-term opportunity with the potential to address significant unmet medical needs in patients vulnerable to streptococcus pneumonia infection. Preclinical data for SG-001 demonstrated broad serotype-specific antibody activity. encompassing a wider range of pneumococcal serotypes than those targeted by any currently available pneumococcal vaccine, underscoring the potential for Sg001 to provide enhanced protective coverage. We view this program as a natural extension of our core competencies in hyperimmune Ig development and manufacturing, and as a potential key value driver for ADMA's next phase of growth. Although Sg001 is excluded, from our $1.1 billion or more fiscal year 2029 revenue guidance. We believe approval could occur within this timeframe. And if successful, we believe the new product could rapidly scale to peak revenues following potential commercial launch. We believe SG-001 represents a potential $300 to $500 million in annual high margin revenue opportunity with IP protection through at least 2037. Turning to capital deployment, our approach remains disciplined and strategic, focusing on creating stockholder value. Following our successful JPMorgan-led debt refinancing earlier this year, ADMA maintains an undrawn $225 million revolving credit facility, providing flexibility to fund growth and stockholder value initiatives. We continue to repurchase ADMA shares under our authorized program. funded organically to date through free cash flow, and maintain a strong capital position to potentially reinvest in high-return initiatives that enhance stockholder value. Looking forward, our focus remains clear. Expand incentive access and utilization, scale yield-enhanced production and product mix shift, drive continued margin expansion, advance our capital-efficient pipeline, and return capital to stockholders through share repurchases. We believe these priorities will collectively position us to achieve more than $1.1 billion or more in annual revenue in 2029, with a clear line of sight to durable earnings growth. With that, I'll now turn the call over to Brad to review our third quarter financials in more detail. Thank you, Adam. Our third quarter results highlight ADMA's consistent execution and expanding profitability. Total revenue for the quarter was $134.2 million, up 10% from the second quarter and an increase of 12% year over year. Gross margins expanded to approximately 56.3% compared to 49.8% last year. driven by incentives growing mix and early yield enhancement benefits. Excluding the plasma sale of $13.8 million during the quarter, product level gross margins reached 63.7% during the third quarter of 2025. GAAP net income totaled $36.4 million compared to $35.9 million in the prior year period. while adjusted EBITDA increased to $58.7 million, representing 16% growth quarter-over-quarter and 29% year-over-year, reflecting continued operating leverage and cost efficiencies. Year-over-year net income growth was tempered by a higher effective tax rate and temporary competitive dynamics in the standard IVIG markets, mainly impacting Vivigang. Enabled by the company's outperforming third-party plasma suppliers, ADMA opportunistically completed a sale of approximately $13.8 million of normal source plasma on the spot market at a negative margin contribution to optimize working capital and go-forward cash flow. These factors are short-term. Post-quarter, standard IVIG market conditions are stabilizing. and record ascent of demand continues to drive margin expansion. ADMA ended the quarter with a strong balance sheet and liquidity position. Third quarter cash reflected approximately $23 million in share repurchases settled during the period, planned inventory build, and a $12.6 million facility expansion investment. Working capital dynamics are expected to normalize in the coming quarters, supporting accelerated cash growth through 2026. We maintain a strong balance sheet with an undrawn $225 million revolver, providing ample flexibility for growth. Turning to our outlook, ADMA's full year 2025 and 2026 financial outlook reflects continued incentive demand strength yield enhancement production efficiencies, and disciplined operational execution. For 2025, total revenue is now expected to be $510 million, up from prior guidance of more than $500 million. 2025 adjusted net income is modestly adjusted to $158 million due to a higher effective tax rate. Fiscal year 2025 Adjusted EBITDA guidance remains expected to be $235 million. These forecasted annualized 2025 results position the company strongly to end the year on a high note and enter 2026 from a position of strength. For 2026, total revenue is now expected to be at least $630 million. up from $625 million or more previously. Adjusted net income is increased to more than $255 million, up from $245 million previously. And adjusted EBITDA is raised to more than $355 million, up from $340 million or more from previous guidance. The increased 2026 adjusted net income guidance now considers a full corporate tax rate for fiscal year 2026. Looking longer term, ADMA expects fiscal year 2029 total annual revenue to exceed $1.1 billion, supported by yield enhancement efficiencies, expanding incentive demand, and continued gross margin gains. Potential contributions from SG001 and capacity expansion are excluded from this outlook and represent meaningful upside to ADMA's long-term earnings power. Following its JPMorgan-led refinancing, ADMA maintains a strong balance sheet with an undrawn $225 million revolver and forecasted robust cash generation. Share repurchases continue to be funded organically. reflecting disciplined capital allocation and long-term shareholder value focus. With that, I'll turn the call back to Adam for closing remarks. Thank you, Brad. Before we open the call for questions, I wanted to take a step back and reflect on how far we've come and where we're heading. Just three years ago, ADMA was at the early stages of its commercial expansion. Today, we're generating record revenue and profitability. achieving best-in-class gross margins with substantial expansion forecasted from here, and setting the stage for what should be sustained earnings growth across the next decade while advancing a compelling new product cycle. Our yield enhancement milestone is a defining moment in that journey. It not only validates our technical capabilities, but also positions us among the most efficient plasma fractionators in the industry. With FDA-released yield-enhanced production lots now flowing through our supply chain, we believe we are strongly positioned to finish 2025 on a high note and accelerate year-over-year growth rates in 2026 from a position of operational strength. With line of sight expected meaningful cost savings, improved production mix throughput, and the potential to add incremental manufacturing capacity without significant capital investment, provides optimism for our future. On the commercial side, Ascendant continues to outperform expectations and remains at the center of our growth story. We are witnessing both expanding utilization in existing accounts and growing interest from new treatment centers. As payer access improves in 2026, we expect adoption to accelerate further, supporting our expectations of strong double-digit revenue growth well into the back half of the decade. The combination of expanding coverage, real-world data validation, and increased patient acceptance is creating durable, powerful momentum across ADMA's healthcare ecosystem. Looking further ahead, our R&D platform continues to progress. The SG001 program is advancing on schedule, and we remain enthusiastic about its long-term potential. We believe we can advance this pipeline program directly into registrational trials following continued and successful preclinical development and potential ultimate IND submission. When combined with our manufacturing know-how and regulatory expertise, SG001 has the potential to expand ADMA's leading position in the specialty immunoglobulin space while adding meaningful high margin revenue in the out years. Financially, ADMA has never been stronger. We are operating with a clean balance sheet, a fully funded growth plan, and forecasted accelerating cash generation. Our capital allocation priorities are clear. Reinvest for growth, maintain balance sheet flexibility, and return capital to our stockholders through opportunistic share repurchases. This strategy reflects our confidence in the business and our commitment to building enduring value. In closing, I want to thank the entire ADMA team for another exceptional quarter. Your hard work, expertise, and passion make all of this possible. To our investors and stakeholders, thank you for your continued confidence in our company and partnership as we execute against our mission to improve patient lives while creating durable stockholder value. With that, operator, please open up the call for questions.