ADMA Biologics Inc

Good afternoon and welcome to ADMA Biologics' second quarter 2020 financial results conference call on Wednesday, August 5, 2020. 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 Michelle Papanastos, Managing Director of Argo Partners,

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the second quarter 2020. I am joined today by Adam Grossman, President and Chief Executive Officer, and Brian Lenz, Executive Vice President and Chief Financial Officer. During today's call, Adam will provide some introductory comments and provide a corporate update and then Brian will provide an overview of the company's second quarter and six months and to June 30th, 2020 financial results. Adam will then provide some brief summary remarks before opening the call up for your questions. Earlier today, we issued a press release detailing the second quarter 2020 financial results. 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 recording. It 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 and the risk factors section of our 2019 annual report on Form 10-K and our second quarter 2020 10-Q, which we expect to file following this conference call for a discussion of important factors that could cause actual results to differ materially from those forward-looking statements. With that, I would now like to turn the call over to Adam Grossman. Adam?

Thank you, Michelle. Good afternoon, everyone, and thank you for joining us on this afternoon's call. Thank you for joining us. Thank you for joining us today. We are working on a number of early stage development activities at the present time targeting COVID-19, including testing assays, as well as potential treatments with differentiated plasma-derived therapies. As we progress with these R&D activities, we will be sure to inform our stakeholders. We thank you, our shareholders, for your continued support and commitment as an important part of the ADMA Biologics team, assisting us to pursue forward-thinking research and development activities with the promise and power of plasma-derived antibody products. Thank you. Now I would like to review progress in the second quarter and some of our recent milestones and achievements. At the end of June, we announced the opening and first collections at a new plasma collection center. We have successfully submitted the accompanying Biologics license application to receive U.S. FDA approval for this center Thank you very much. and these investments into ADMA BioCenter's business unit are anticipated to support ongoing production and growth into the future. As many of you are aware, during the second quarter, ADMA joined the COVID-19 Global Plasma Alliance, a plasma industry collaboration led by CSL and Takeda that was established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19. As an alliance member company, Adam's whole and own subsidiary, Adna Biocenters, has been collecting and providing COVID-19 high-titer plasma to the Alliance from individuals who have recovered from COVID-19 infection. We are truly grateful for all of the donors who continue to do good for others and donate their plasma. We need many more donations as an industry, and we encourage all U.S. citizens to make a difference and donate your plasma. Thank you for joining us today. Thank you for joining us. Thank you very much. Adma must not lose sight of the fact that building brand loyalty and ensuring that our patients need not worry if they will have their IG supply next month or the months thereafter is of paramount importance for the long-term success of our business. We are a company committed to responsible inventory management and treat our prescribers, patients, and distribution partners' needs as a top priority. As we continue the commercial rollouts of Biv again and Ascentive, as well as continue to promote the use of non-BHB in the face of the logistic and engagement challenges due to COVID-19, our company's grassroots promotional efforts are starting to pay off. We've been setting the stage for building long-term brand loyalty and company awareness in a market that has been dominated by large players for decades. We are building a business one patient at a time. Thank you very much for joining us. Thank you very much. Thank you for joining us. Thank you for joining us. These delays were experienced during the latter part of the second quarter, which have been resolved during July. In response to these delays and in partnership with the FDA, we rapidly identified and added additional release testing laboratories to our approved consortium listed in our drug approval documents. We believe that we completely resolved this issue, and we do not anticipate any additional testing or batch release delays going forward. As of mid-July, we began receiving FDA releases for several completed product badges with our new testing laboratories data. As we'll be seeing in our second quarter 2020 10Q, our finished goods inventory has increased 75% to $9.1 million since year-end December 31, 2019. This translates into having more product badges ready for commercial sale as soon as the testing results are received. Thank you very much. Thank you for joining us. Thank you for joining us. We also purchased and installed a new aseptic filling machine, a VanRx SA25 work cell, and manufactured four conformance batches of Bibigam at an increased scale that will allow us to ultimately manufacture at twice the volume compared to the scale that is FDA approved and in place today. These important initiatives are designed to reduce operating costs, improve our overall margins, and provide for faster production cycle turnaround time. providing the company with increased control and independence from third-party vendors and contractors. We remain on track to submit the appropriate applications to the FDA during the second half of 2020 and into 2021 and expect to begin benefiting from our supply chain investments as early as mid-2021. As we progress and make these regulatory filings, we will report any material news as it develops to our shareholders. Like many other companies in the life science sector, we experienced our share of COVID-19 challenges during the second quarter. In addition to the delay in expedient resolution of the final GMP product release testing that I mentioned earlier, we also experienced certain COVID-19 related impacts to other areas of our supply chain, as well as our commercial engagement efforts. As a result of past state and local shelter-in-place orders, we experienced lower than normal donor collections at our FDA-approved plasma center during the second quarter. During this early part of the third quarter, we have already observed an increase in plasma collections compared to the second quarter in 2020. We also experienced delayed shipments of non-plasma bore materials, source plasma from our contracted third-party suppliers, as well as delays in deliveries of personal protective equipment, reagents, and supplies used in the manufacture of our products. During the quarter, we observed certain impacts to our customer engagement initiatives. Thank you for joining us. Thank you for joining us. Thank you very much. Congrats to the team, if you're listening, for achieving this great milestone. And with that, I'll turn the call now over to Brian Lenz, our CFO, to review the financials. Brian?