ADMA Biologics Inc

And welcome to the ADMA Biologic Second Quarter 2024 Financial Results and Business Update conference call on Thursday, August 8th, 2024. At this time, all participants are in the 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 Skylar Bloom. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss Adma Biologics financial results for the second quarter of 2024 and recent corporate updates. I am 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 second quarter of 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the second quarter of 2024 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 SEC filings, 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 the 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 quarterly report on Form 10-Q. for the quarter ended June 30th, 2024, 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. 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.

Thank you, Skylar, and welcome everybody to today's call. It has been quite a journey to eclipse $100 million in revenue during a single calendar quarter. We are extremely proud to have achieved this milestone while managing expenses such that our earnings growth to date positions ADMA among the fastest growing and profitable companies in the biotech sector. It is truly remarkable, and I salute and applaud the entire ADMA team. Our unwavering commitment to commercial, financial, and operational excellence has once again yielded strong results during the second quarter, exceeding analysts' forecasts. Total revenues for the quarter grew by 78% year-over-year, reaching $107.2 million. This impressive revenue growth coupled with a tightly managed cost structure resulted in adjusted EBITDA of $44.5 million. representing a nearly 600% growth rate year over year. Gap net income grew to $32.1 million during the second quarter, compared to a gap net loss of $6.4 million in the same period last year. While Brad will delve into the details, this quarter benefited from a one-time accrual reversal, which increased both reported revenue and earnings. Although this favorable impact is non-recurring in nature, The strength of our underlying business gives us confidence that we will be able to grow both the top and bottom lines from this new, significantly increased financial baseline. We are again revising our financial guidance upwards for both 2024 and 2025. Based on current market conditions, we now anticipate generating total revenue of more than $400 million for 2024 and $445 million for 2025. At these revenue levels, we estimate adjusted EBITDA will exceed $150 million and $200 million for 2024 and 2025 respectively, representing a 33% year-over-year growth rate. Similarly, we are increasing net income guidance to more than $105 million for 2024 and $155 million for 2025, reflecting an estimated 48% year-over-year growth rate. Our confidence in achieving these financial targets is underpinned by the rapid and continuous growth of our unique and proprietary immunoglobulin, Ascentive. All forward-looking demand KPIs for the product are reaching new highs. And encouragingly, both the breadth and depth of Ascentive's prescriber base continues to strengthen. As a result, I am pleased to report that Ascentive has now surpassed a 50% contribution to ADMA's total revenue. marking a significant milestone for our company and setting the stage for further anticipated favorable mix shifts. To meet the growing demand for incentives, we are implementing measures to increase the availability of high-titer raw material plasma, and we are continuing to shift production capacity towards incentives. We are making progress with these initiatives. And when completed, we believe Ascentive has the potential to contribute a significant majority to our total product revenue mix in due course. To better understand Ascentive's unique position and growth potential within the $12 billion and growing U.S. immunoglobulin market, it is critical to consider our core focus on the 20,000 to 30,000 risk-stratified refractive immunodeficient patients who have exhausted multiple lines of therapy throughout their treatment journey. These patients suffer from complex comorbidities, have often failed multiple standard immunoglobulin therapies, and require additional concomitant medications. The unfortunate reality is these patients are regularly unable to conduct daily activities, including attending school or maintaining steady employment due to their complex health conditions, doctor's office visits, and hospitalization. Ascenta's unique and proprietary composition has proven to be well-suited to address the challenging real-world use cases. To further illustrate, during the second quarter, we released a new patient video testimonial on the Ascenta product website, highlighting the remarkable treatment journey of a 17-year-old immunocompromised patient on IVIG therapy. His inspiring story of resilience has resonated deeply in both the clinical and commercial settings. The founding principles of ADMA were built precisely with patients like this in mind, and it is these success stories that continue to fuel our organization to improve the lives of immune compromised patients. While we are proud of the growing number of patients treated with Ascentive to date, there is still much work to be done, and there are many patients we have yet to reach. We estimate that Ascentive's current penetration within its core target market is less than 3% of the total addressable population, which has been largely governed by our ability to meet the outsized product demand. We are confident that the incremental additional penetration with Ascentive will accelerate near-term revenue and create substantial peak revenue opportunity beyond our 2025 guided baseline. In that context, I would like to say that all of us at ADMA are extremely focused and will work tirelessly to produce more Ascentive to meet the outsized demand. Ascentive is proving to be a unique and potentially life-changing treatment option for PI patients who had limited alternatives before its launch. Given this context, our efforts to potentially enhance immunoglobulin production yields through innovations in our manufacturing processes have continued to advance in 2024. Recent commercial scale production of our new processes demonstrated potential yield enhancement of approximately 20% more bulk drug from the same starting plasma. These initiatives are subject to further regulatory evaluation and review. And if approved, we anticipate realizing potentially transformative benefits beginning as early as late next year with revenue and earnings accretion then expected to accelerate over the course of the decade. As appropriate, we will formally guide to the magnitude and timing of these benefits as regulatory and operational developments progress. On the plasma supply front, our collection centers continue to perform well, which we believe positions us to meet increased production forecasts for our IG portfolio. Hyperimmune plasma collections are increasing to support the growing demand, and collection volumes across our network are reaching new highs. We believe we are well positioned for continued growth and innovation with a strong foundation for future success. Moving to Admolytics, our innovative AI and machine learning platform. We successfully expanded implementation of the technology to our commercial operations during the second quarter. When fully implemented, we expect the rollout to further optimize our commercial growth strategy. Initiated in February of 2024, The staggered implementation of Admolytics has already yielded impressive results, including increased production efficiency, enhanced visibility into the manufacturing process, optimized commercial planning, streamlined plasma pooling, and reduced variability in FTE hours. These efficiencies are expected to solidify our rapidly growing earnings outlook. Our portfolio of life-changing medicines provides significant benefits to patients addressing diseases with unmet needs. We are proud of the difference we make for patients, donors, and public health. Our accomplishments showcase the steadfast commitment and hard work of our exceptional team. To our employees, we extend our heartfelt gratitude for your dedication, which drives our progress and significantly helps those we serve. It is this collaborative spirit that makes our workplace unique. And with that said, I'd now like to turn the call over to Brad for our review of the second quarter 2024 financials.