ADMA Biologics Inc

Ladies and gentlemen, this is the operator. Today's conference call will begin in two minutes. Until such time, your line will remain on music hold. Please continue to standby. We thank you for your patience. Once again, today's conference call will begin in two minutes. Until such time, your line will remain on music hold. Please continue to standby. We thank you for your patience. Music Music Music Music Biologics Inc. Music Music Music Music Good afternoon and welcome to the ADNA Biologics First Quarter 2020 Financial Results Conference Call on Wednesday, May 6, year 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 Mr. Sam Martin, Managing Director at Argot Partners, ADMA's investor relations firm. Please go ahead.

Welcome, everyone. and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the first quarter 2020. I'm 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 first quarter 2020 financial results. 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 first quarter 2020 financial results. The release is available on our website at 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 Security 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 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. We refer you to the disclosure notice section in our earnings release we issued today and the risk factors section of the annual report on Form 10-K 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, Sam. Good afternoon, everybody, and thank you for joining us on this afternoon's call. So the first quarter of 2020 has been unprecedented due to the global COVID-19 pandemic. Faced with seemingly insurmountable challenges, Many of us have adapted, changed our behaviors and have reflected on what is meaningful to ourselves, our loved ones and our community. We see that as long as we can modify our behaviors, there are solutions to be found to ensure we continue to make progress in our lives and not let bumps in the road stop us from achieving our goals. I am proud to report that the staff of ADMA has been adaptable, problem solving and resilient during these times. while also managing their personal lives like all of us participating on today's call. I would be remiss if I didn't express our sincere gratitude to our dedicated, hardworking staff for continuing to give of themselves to ensure ADMA's plasma-derived polyclonal antibody products are available to patients in need. I would like to commend and express our sincere gratitude for the dedication of our country's first responders. Physicians, nurses, scientists, government agencies, and the global healthcare community for coming together united to develop a prevention and cure for COVID-19. We are proud to play a small role in supporting the worldwide effort to combat this terrible infectious disease and have pledged our support and knowledge to the combined efforts of the COVID-19 Global Plasma Alliance led by CSL and Takeda as contributors. Thank you for joining us today. Thank you for joining us. Thank you for joining us today. Thank you for joining us. As previously disclosed, we invested in our supply chain robustness strategy and continue to make progress with reinforcing our commercial infrastructure by building on our sales force and medical affairs teams while generating encouraging first quarter total revenues of $10.2 million, which represents a 189% increase over the same period in 2019. Biv again and Ascendant commercial launches continue to progress Thank you for joining us. Social Distancing and other government-enforced policies and laws, which include reduced in-person field force meetings and commercially focused opportunities resulting from medical conference cancellations, along with a decrease in customer site visit opportunities at hospitals and other medical institutions due to shelter-in-place orders across the country. As such, we are developing and have successfully implemented a number of virtual engagement initiatives with prescribers, key opinion leaders, and other healthcare professionals to facilitate the ongoing commercial rollout. We continue to operate at our Boca Raton, Florida production facility without any significant impact from the COVID-19 crisis. Production timing is generally on schedule and in line with our internal forecasted ramp-up of immune globulin manufacturing throughput for our three commercial products and intermediate fractions. We continue to build our inventories to support the overall increasing market demand for immune globulin and to support the continued sales growth and market penetration of our commercial plasma products. While we are not experiencing any significant decreases in and our plasma collection operations to date. There have been reports that other plasma collection organizations are experiencing noticeable declines in their collections. We continue to closely monitor the global COVID-19 situation and are pleased to report again that we are not experiencing any material impact to our supply chain or operations at this time. Before I turn the call over to Brian to review the financial highlights, The most important point of my statements today is that our supply chain robustness plan remains on schedule and the expansion of our manufacturing facilities capacity remains on track. Thank you for watching. Thank you very much. Thank you very much. Additionally, we anticipate the total volume of intermediate fractions that we produce will grow in line with the increased production capacity, providing further benefits from these investments into our IG manufacturing process. Once these new systems and processes are in place and we receive any and all required regulatory approvals, we believe we will have the ability to ramp up total overall plant production capacity We continue to remain on target with the expansion efforts of our Plasma Collection Center business unit. During the quarter, we commenced the build-out of additional plasma centers and secured additional locations and leases as planned. The expansion of our plasma collection center network is designed to enhance our control over the valuable raw material source plasma used to produce our immune globulin products. These three substantial objectives, increased raw material plasma collection, expanded production capacity, and aseptic filling capability, are anticipated to change the forward-looking outlook for ADMA in many positive ways, including potentially lowering costs, Thank you very much. Thank you for joining us. Thank you for joining us. expand the manufacturing capacity of our Boca Raton facility, including adding certain important supply chain functions, and to further bolster our supply chain by allowing us to expand our plasma collection facility network. We are grateful to our shareholders for your trust and thank you for your commitment to plasma-derived antibody products. Before they were mainstream news and dinner table conversations, your investment in ADMA Biologics is making a difference in the lives of countless patients who require immune globulin and other plasma-derived therapies. We thank you for your support and trust. I would like to touch on the recent filing of our proxy statement. In April, we nominated a new director for election, Ms. Martha Dembski, to the ADMA board. Martha is an experienced board member who, if elected, will bring more than 35 years of biotech manufacturing, operations, and financial experience to ADMA's Board of Directors. In her most recent full-time position, she served as Senior Vice President and Chief Financial Officer of Ajinomoto Althea up until her retirement in 2017. She currently serves as Chairman of the Board at Chimerics, as well as a director at Adamus Pharmaceuticals and Equilium Incorporated. We believe that Martha brings great operational, manufacturing, supply chain, and public company accounting and governance experience to our rapidly growing company, especially as we enhance our supply chain and increase our potential contract manufacturing capabilities. We encourage our shareholders to vote their proxies according to the company's recommendations. In March, we announced strengthening of our intellectual property estate, further protecting Ascentive. We received a notice of allowance from the U.S. Patent Trademark Office for a patent extension application covering immune globulin plasma pool compositions used in the manufacturing of Ascentive. The patent extension is expected to publish during the first half of 2020. And finally, in early January... Thank you for joining us. Thank you for having me. Thank you, Adam. Since we issued a press release earlier today outlining our first quarter 2020 financial results, I'll just review some of the highlights. To begin with, our total revenues for the first quarter 2020 are