ADMA Biologics Inc

good afternoon and welcome to the adma biologics third quarter 2022 financial results and corporate update conference call on wednesday november 9 2022 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 skyler bloom Senior Director, Business Development and Corporate Strategy at ADMA Biologics. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the third quarter of 2022 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer, and Brian Lins, Executive Vice President, Chief Financial Officer, and General Managers of ADMA Biocenters. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brian will provide an overview of the company's third quarter 2022 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 2022 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 filing 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 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 sections of our 2021 annual report on Form 10-K for the year ended December 31st, 2021, as well as the risk factors section of our quarterly report on Form 10-Q for the quarter ended September 30th, 2022, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. With that, I would now like to turn the call over to Adam Grossman. Adam?

Thank you, Skylar. Good afternoon, everyone, and thank you for joining us on today's call. We hope everyone remains healthy and safe. We believe our strong third quarter performance demonstrates our company's successful execution of our multi-year strategy, and speaks to ADMA's compelling prospects as we look to 2023 and beyond. In keeping with ADMA's track record of delivering on our objectives, we are pleased to now again be raising financial expectations for full year 2022. The company now expects to generate total revenues of approximately $145 million, increased from the $130 million previously provided. We believe the third quarter revenue growth of 99% year over year, coupled with the favorably evolving product mix, establishes a strong foundation for the company to accelerate towards profitability. As Brian will detail, we expect the coming quarters will better illuminate the pathway to profitability and increase visibility of the robust growth opportunities thereafter. Elevated incentive demand trends persisted throughout the third quarter. and have now continued into the fourth quarter. The body of commercial evidence we have been able to successfully demonstrate for Ascentive throughout 2022 gives us confidence in our belief that the product will continue to rapidly grow throughout 2023. And ultimately, we believe Ascentive is well positioned to account for a greater portion of our overall revenue product mix than we have historically messaged. We regard 2022 as a new launch year For incentives, due to the initial unthawing of pandemic-related barriers to physician, provider, and patient engagement, which throughout COVID impacted our ability to detail the truly unique product profile. With the first year of the new incentive launch coming to a close, our enthusiasm cannot be overstated as we upwardly revise our internal forecast to account for the product's expected growth trajectory and peak opportunities. To build on Ascenta's rapidly growing launch trajectory, during the third quarter, we opportunistically mobilized a targeted medical education and conference symposia strategy, identifying clinical needs in managing respiratory infections in the immunocompromised host. We are pleased to report that these initiatives were met with a strong reception, including full capacity standing only attendance of symposia discussions of real world experience of incentive in patients with primary immunodeficiency. Also during the quarter, case studies were presented by nationally recognized clinical experts in the area of transplantation, infectious disease, and immunology at national and regional medical meetings, including the Immune Globulin National Society, Infectious Disease Week, and the Florida Allergy and Asthma Immunology Society meetings. All told, we believe our commercial and medical affairs strategy is being successfully borne out for Ascentive, and we believe we are in the early days of the product's significant growth potential. Perhaps most importantly, the problematic and at-risk primary immunodeficient patients being treated with Ascentive are demonstrating real-world benefits and quality-of-life improvements. Anecdotal market feedback remains resoundingly positive. And this patient population is oftentimes poorly controlled on standard IG products. Additionally, although we are scientifically excited by the prospect of a potential RSV vaccine approval for the broader population, the unfortunate reality is that vaccines have limited utility in immune compromised people, adverse target patient population. It is exclusively this population, high risk primary immune deficient patients, that ADMA aims to serve with a sentence. We believe our product success validates and supports our company's mission to commercialize novel products for immunodeficient patients at risk for infections. It is our devotion to this underserved population that fuels us, and we believe that the ADMA biologics name is now synonymous with trust and confidence amongst many physicians, providers, and patients. Additionally, during the third quarter, we advanced the post-marketing clinical studies for Bibigam and Ascentis. To date, we are enrolling our Bibigam trials faster than anticipated, and the excitement amongst participating investigators has been notable for both products. We believe this investigator enthusiasm speaks to the reputation ADMA and its products have established in the market and may well prove to be an indication of the unmet need in this patient population. If successful and provided FDA authorization, the ongoing pediatric requirement studies will potentially expand the indication for both products to include pediatric-aged primary immunodeficient patients. Turning to BIVIGAM. Our confidence in the near-term and longer-term growth trends is building. BIVIGAM product revenue and demand pull-through reached record highs during the third quarter, driven by end-market IG growth as well as ADMIS continued market share gains. Various industry reports now suggest that ADMA Biologics has established a 1.5% to 2% market share in the rapidly growing US IGN market. Moving forward, we anticipate continued share gains as well as structural tailwinds from IG market growth. ADMA remains committed to delivering the continuity of patient care. Our strong normal source and RSV hyperimmune plasma supply inventories, which are included in the total inventories, of $163 million recorded at the end of the third quarter are anticipated to support all upwardly revised revenue forecasts on an ongoing basis across our IG portfolio. This robust plasma supply position is the result of the execution by our BioCenters team in rapidly expanding our internal plasma collection center network and management's assertive efforts to secure third-party plasma supply contracts. We believe the strong inventory position we have built, including the favorable procurement of external plasma, will provide for financial flexibility in the periods ahead. We routinely entertain plasma supply requests from third parties, and we will continue to opportunistically monetize excess plasma when value created, particularly so as we have now built total inventories to the upper bound, which we forecast will trend between $150 million to $175 million moving forward. With respect to macroeconomic conditions, we continue to believe the supply chain measures ADMA has achieved to date, in addition to the inherent counter-cyclicality of the plasma industry, together positions the company to successfully navigate challenging operating backdrops and further accelerate in more normalized economic conditions. We believe the remuneration for plasma donation can help donors manage and offset increased pressures due to historic consumer inflation rates. It is in this context that ADMA is proud to be a trusted partner with the local communities we serve, and we look forward to welcoming many more donors to our state-of-the-art biocenters. These significant accomplishments across our business could not have been possible without the dedication and focus of ADMA staff, leadership, and advisors. Thank you for your dedication and hard work in achieving our corporate goals and delivering on our commitments to the patients, prescribers, and stockholders to whom we have made these promises. We commend the entire ADMA team for your important efforts focused on improving healthcare for patients who we know are counting on us. Additionally, before turning the call over to Brian, I would like to confirm our strategic alternatives process remains ongoing and the exploration of value-creating opportunities we will update the market as developments materialize. With that said, I'd now like to turn the call over to Brian for a review of the third quarter 2022 financials.