ADMA Biologics Inc

Good afternoon and welcome to the ADMA Biologics fourth quarter and full year 2024 financial results and business update conference call on Monday, March 3rd, 2025. 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 ADMA Biologics financial results for the fourth quarter and full year 2024 in recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer, and Brad Tate, 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 fourth quarter and full year 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for your questions. Earlier today, we issued a press release detailing the fourth quarter and full year 2024 financial results and summarized certain achievements and 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 any 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 of our previously issued SEC filings, and our annual report on Fund 10-K for the year ended December 31, 2024, once filed on or before March 18, 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 said, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

Thank you, Skylar, and welcome everyone to today's call. 2024 was a year of exceptional performance for ADMA, marked by significant financial growth and operational achievements. Total revenues reached $426.5 million, reflecting an increase of 65% year-over-year. Adjusted EBITDA grew to $164.6 million, representing a growth rate of 309% from the previous year. These results are a testament to the real-world benefits our biologic therapies continue to deliver to immune-compromised patients throughout the United States, as well as the dedication and expertise of our leadership team and exceptional staff. Our commitment to financial and operational excellence continues to drive strong performance. allowing us to once again revise our financial guidance upwards. We now expect total revenue to exceed $490 million in 2025 and $605 million in 2026, with adjusted EBITDA projected to surpass $225 million and $305 million, respectively, in 2025 and 2026. Adjusted net income guidance for 2025 and 2026 is now raised to more than $175 million and $235 million, respectively. We anticipate continued margin expansion as our revenue mix shift towards incentives, which we believe represents a potential billion-dollar or more opportunity with lasting growth and brand durability through at least 2035 and likely beyond. In anticipation of a potential mid-year regulatory approval for our enhanced yield production process, we increased medical education and marketing efforts at key scientific conferences in the fourth quarter while preparing for an increase in high-titer plasma supply, work in process, and finished incentive inventories. Throughout commercialization, we have strategically managed new patient start to ensure continuity of patient care and maintain an uninterrupted drug supply. And we have accordingly taken a conservative and thoughtful approach to onboarding new Ascentive patients. Ascentive's forward-looking demand metrics are making new all-time highs into 2025, which has resulted in a queue of identified new patients waiting to initiate Ascentive treatment. Having currently penetrated what we believe is just over 3% of Ascentive's targeted, complex, and refractive PI market, we have strong visibility into scaling new patient starts in the coming periods, and we believe we can address the significant unmet needs within this PI patient population. We believe our recently executed third-party high titer plasma supply contracts mark a transformative milestone paving the way for what should be long-term top-tier growth for ADMA. These long-term agreements allow the company to source high-titer plasma from approximately 250 U.S.-based third-party plasma collection centers, representing approximately a five-fold increase in total collection capacity. While we continue to ramp up these third-party high-titer procurement contracts at a rapid pace, We've also grown internal high-titer collections to record levels. These third-party supply contracts, combined with the robust internal plasma collection trends, are expected to sustain incentives revenue growth and position us to potentially exceed $1 billion in total annual revenue prior to 2030, with anticipated growth headroom thereafter. we deeply appreciate the commitment of our plasma supply partners to our company and to the immunodeficient patients we all collectively serve. We believe the anticipated approval of our enhanced yield production process represents a transformative opportunity for the company. This innovative process has demonstrated an ability to increase production output by approximately 20% from the same starting plasma volumes, potentially driving meaningful increases to financial guidance if approved. Our scientific, technical operations, and regulatory teams have been instrumental in advancing this novel process, and our ongoing regulatory dialogue reinforces the confidence in timely potential approval by mid-year 2025. Upon approval, we are well prepared to swiftly implement the new process enhancements, which would drive commercial sales and financial upside beginning potentially in the second half of 2025. Consistent with our conservative guidance approach, any revenue generated from immune globulin produced using this enhanced production process would represent potential upside to our current 2025 and 2026 financial projections. We believe the anticipated increase and available high-titer plasma supply will enable us to meet Ascentive's growing demand in the coming quarters, accelerate revenue and earnings growth, and further build on Ascentive's still-developing growth curve. Ascentive's robust intellectual property estate, covering proprietary screening assays, plasma pooling formulas, methods of immune globulin use, secures brand protection through at least 2035. with potential extensions extending beyond. Regulatory barriers and proprietary know-how further safeguard our franchise. Our comprehensive IP portfolio, encompassing immune globulin treatment for all virally-induced respiratory infections, supports our expectations that Ascenta alone could surpass $1 billion in total annual revenue. With strong intellectual property and regulatory protections ensuring a long runway of profitable growth, we are building what we believe will be among the most durable earning streams in the biotech and pharmaceutical sector. We continue to advance our lead R&D pipeline program, SG001, targeting strep pneumonia, representing an additional upside lever to currently provided $1 billion total annual revenue guidance. expected to be realized prior to 2030. If approved, SG-001 could contribute $300 to $500 million or more in high-margin annual revenue. Issued IP protecting SG-001 ensures branded protection through at least 2037 with the potential for extensions. We are confident in our ability to advance this program through development and potential regulatory approval in a highly capital-efficient manner. We believe the strength of our balance sheet and our increasing net cash position provide a solid foundation to execute from a position of strength, with the flexibility to act opportunistically should market conditions shift. At year-end 2024, total cash holdings exceeded $103 million, representing a net cash surplus relative to the $75 million of total debt currently outstanding with Aries Capital. This strong financial position should enable us to continue executing our strategic initiatives while maintaining disciplined capital allocation. With our fully U.S.-domiciled operations and supply chain, coupled with our growing portfolio of life-changing medicines which continue to address clinical unmet needs for the immune-compromised, we believe that we're well-positioned to continue to execute on our business plan in the current political and economic backdrop. We take great pride in the impact our work has on patients, plasma donors, and public health. The achievements outlined here are a direct result of our team's dedication and commitment to excellence. We extend our sincere appreciation to our employees for their hard work and determination, qualities that define our company and we believe set us apart in the industry. Finally, prior to turning the call over to Brad, who will speak to the matter in additional detail, I'd like to address the ongoing KPMG audit process. The successful consolidation of reporting ADMA's financial results is an important milestone for the company as ADMA's financial profile continues to rapidly grow and improve. Management and our audit committee have met with KPMG prior to releasing the financial results today, and we feel confident that our reported financials are accurate, and we do not anticipate any changes to these financials once the 10-K is filed on or before March 18, 2025. As previously disclosed, KPMG was engaged by ADMA as the company's new independent registered public accounting firm in the fourth quarter of 2024. The company graduating to a Big Four independent accounting firm and releasing our reported financials today should instill confidence in the accuracy and quality of our financial statements for our stockholders. With that said, I'd now like to turn the call over to Brad for a review of the fourth quarter and full year 2024 financials.