Good afternoon, and welcome to the ADMA Biologics First Quarter 2020 Financial Results Conference call on Wednesday, May 6, 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 Web site 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 Web site at admabiologics.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 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?

Thanks, 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'm 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, hard-working 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. We are proud to be included with these great companies working together to fight COVID-19 with the promise of immune globulin therapy. Alliance members will contribute specialists, advisory expertise, technical guidance and/or in-kind support to contribute to the Alliance's goal of accelerating the development of a hyperimmune globulin as a potential treatment…

Thank you, Adam. Since we issued a press release earlier today outlining our first quarter of 2020 financial results, I'll just review some of the highlights. To begin with, our total revenues for the first quarter of 2020 were $10.2 million compared to $3.5 million for the first quarter ended March 31, 2019, and this represents an increase of approximately $6.7 million or 189%. The higher revenues are mainly attributed to our multiple revenue lines, increased sales and production throughput of $6.4 million of our immunoglobulin plasma products generated by our manufacturing operations at our Boca facility, and a $300,000 increase in plasma revenues generated by our plasma collection facility in 2020 as compared to the same period in the prior year. Our increased revenues for the first quarter of 2020 compared to the first quarter of 2019 were largely a result of the FDA approvals of BIVIGAM and ASCENIV on May 9, 2019 and April 1, 2019, respectively, along with the long-term manufacturing new customer supply agreement we entered into in January 2020 to produce and sell intermediate fractions. Our consolidated net loss for the first quarter of 2020 was $19.2 million or $0.26 loss per basic and diluted share. This was compared to a consolidated net loss of $13.1 million or $0.28 loss per basic and diluted share for the first quarter of 2019. The increase in net loss of $6.1 million was primarily due to the increase in cost of product revenues of approximately $7.4 million. This increase was mainly a result of the manufacturing of BIVIGAM’s conformance lots at an increased plasma pool production scale, and this pertains to our planned capacity expansion and other production enhancement initiatives and investments at the Boca facility. The additional increase in net loss during the first quarter of 2020…

Thank you, Brian. The first quarter of 2020 demonstrated to me the team at ADMA is adaptable and willing to accept changes without hesitation. Our team has risen to the occasion time and time again to do whatever it takes in the face of challenges and adversity to keep the company on track to meet its goals and objectives. To my team listening on the call today, first, I thank you for listening. Secondly, I'm proud of you for continuing to make progress and maintain high productivity levels during this uncertain time. Due to the strong foundation we have built, we believe that we are well positioned to weather the current macroeconomic market challenges while continuing to execute on our future growth plans. In closing, I would just like to highlight that we remain deeply committed to successfully navigating the ongoing commercial rollouts of BIVIGAM and ASCENIV and bringing each product to patients with life-threatening immune deficiencies. We look forward to sharing ADMA's continued progress with you all as 2020 progresses and we wish you all continued health and safety. And with that now, operator, we’d like to open up the call for some questions.

Thank you. Today’s question-and-answer session will be conducted electronically. [Operator Instructions]. Your first question comes from the line of Anthony Petrone from Jefferies. Your line is now open.

Thanks and congratulations on the quarter and hope everyone’s staying safe. Maybe, Adam, I’ll start with a few questions on the more recent trends where we’re getting updates from a number of companies just on how trends in March were exiting the last few weeks of March and then any updates in April, specifically, I guess both on the source plasma side in terms of collection volumes but also just anything notable on the infusion clinic size? Are you seeing any impacts in terms of scheduling for IG appointments and things like that? And then I have a few follow ups.

Sure. Anthony, I can speak to ADMA and our operations and then I can speak to some of the things that I hear through my participations at the PPTA Board level and just through conversations that I’ve had. First and foremost, ADMA, we are experiencing very, very minimal collection interruptions, if you will. It’s plus or minus 5%. We’ve not seen any significant impacts to our internal collection operations. Additionally, our plasma supply contracts, they are completely in full force and we are receiving all the deliveries. There’s no [indiscernible] for our collectors. They have to manage the inventory themselves. So from ADMA’s perspective, there is no impact to our raw material chain at this time. With respect to IG, again, BIVIGAM is selling, BIVIGAM is being utilized, it’s being pulled through the channel. We have not heard any significant issues with respect to BIVIGAM during the quarter. What I can comment on with respect to things that we just know, there’s some other companies out there that have reported between 20% to 30% declines in collections. Now, it varies upon region, it varies by collector, so it’s really hard for me to speak specifically about each individual competing plasma company out there. But the overall sentiment that I’m hearing is that it probably was a three to five-week period between March and maybe the beginning of April where the industry saw a substantial decrease, 20% to 30% decrease. However, it was for a very, very short, a finite period of time. And I actually listened to a conference call the other day from a company like Humanatics and they were saying how they already seen volumes come back to normal as early as mid-April. So from my perspective, I think that there probably had been some patients that may…

And just two follow ups, one for you Adam, one for Brian, in terms of development of a hyperimmune IG product for COVID, what are your high level views on that program in terms of timing when we could see a hyperimmune globulin? Will that be a seasonal product? And exactly what is ADMA’s role on the Plasma Alliance? And then for Brian, can you just quantify what will happen to the working capital cycle when you take the three initiatives the company has invested in; raw material, production and aseptic filling, where is the working capital cycle now in terms of months and where can it go once those are all fully in place? Thanks, again.

Brian, since we’re not in the same room today, I’ll take the first part first.

Absolutely.

Sure. So, Anthony, I can – not to sound like a broken record, but plasma supply is by far the largest rate-limiting factor with respect to the development of a hyperimmune for COVID-19. Collecting plasma, getting people to feel like they’re ready to go out of the house and go and donate, this is really something that the Alliance, the PPTA, the President himself had been advocating for. So I think trying to make a product is really dependent upon how quickly the Plasma Alliance can work to collect the raw material plasma that we need. As you know, there’s no vaccine to stimulate antibody. And as you know, it’s – even though it’s a major problem and it’s taking over our lives, there are still in this scheme of our total population very few people infected. We have a population of about 340 million people and there’s only a few million people that have tested positive. So that’s why we’re encouraging anyone to go and donate plasma right now because the asymptomatic people who never had a test, they don’t know. A number of plasma centers across the country have already implemented the use of antibody detection tests that are now commercially available over the last couple of weeks, and I think that that is really what’s going to drive the timing. I’m not a spokesperson for the Alliance, Anthony, so I’m going to have to direct you to them for comment with respect to how quickly that they can bring the product to market. But it really right now is all dependent upon the supply of raw material plasma. And one of the key activities that ADMA is going to be contributing is obviously any COVID positive donors, we’re going to be sharing that inventory with the Alliance to help increase the amount of supply that they have available to make hyperimmune globulin for investigation. Our role with the Alliance is also to support them through rather scientific and advisory means. As you know, we are pretty knowledgeable with respect to microneutralization assays that they pertain to a respiratory viral pathogens and we’ve extensively studied the role of immune globulin in treating certain respiratory viral infections. And we think that we have the ability to provide some knowledge, knowhow and insight to help collaborate with these larger plasma companies. And quite frankly we were asked to join because I believe that these other companies believe that we do add value to the industry and that we do have certain knowhow and technology that could be valuable in the development of our specific hyperimmune against COVID-19. So hopefully that answers your question. Brian?

Thank you for your question, Anthony, regarding working capital and cycle times. If we recall in our corporate presentation, we discussed the timeframe it takes to manufacture one lot of an FDA approved product and that ranges anywhere from 7 to 12 months, it could be longer. We view the investments that we’ve made here in the first quarter of the filling machine, the capacity expansion of the BIVIGAM plasma pool scale up, these investments are imperative to undertake the successful achievement for the company from approved margins providing a path to market faster. This will also provide obviously improved inventory terms, inventory to sales cycles’ metrics. Again, it will essentially improve overall working capital and putting cash back into the business faster and on our way to a path to profitability. So when you’re kind of thinking about the 7 to 12 months and now seeing once we get the filling machine and capacity expansion process approved, we’ll see a reduction in product production batch cycle times and this will give ADMA additional end-to-end control obviously of our approved product manufacturing process and it could reduce our working capital timeframe of outlay of inventory to receiving cash from the sales by, we would believe, somewhere maybe two to three months, it could be even more.

Okay. Thank you.

Thank you, Anthony.

Your next question comes from the line of Elliot Wilbur from Raymond James. Your line is now open.

Hi, Elliot.

Hi, there. Thanks for taking the questions. Good to hear from you guys. First question for Adam I guess with respect to BIVIGAM and ASCENIV just in the context of COVID-19 and plasma therapy which obviously have kind of moved fund to share now in terms of mainline therapeutic options. Obviously that’s been focused more on convalescent plasma and the prospect for a hyperimmune, but I guess we’re starting to see some of an emerging body of discussion regarding the use of traditional IVIG therapies in the treatment of COVID-19. I know there’s a couple of studies in China they have kicked off in recent weeks, there’s one at Sharp Memorial in San Diego looking at open label use of IVIG in earlier [ph] dependent COVID-19 patients. Then we’ve seen some recent case reports of this unusual sort of pediatric inflammatory condition being reported in New York City and Georgia. So it seems like there may potentially be a role for IVIG in treatment of COVID-19. Just wondering what you’re hearing there and whether or not there’s been any discussion as far as either participating in the trial or some sort of open label studies with investigators.

Sure. I can tell you, Elliot, that both BIVIGAM and ASCENIV are commercially available. I don’t have insights into all the diagnoses and the reasons why docs are using one product or another in particular patients. A lot of – it’s also protected under HIPAA rules and regulations. We have not made any public disclosures yet about any patients being treated with ASCENIV for COVID. If and when there is an appropriate amount of data that we are able to generate and work with clinicians on, certainly we will make that public. I can tell you that just from the thought process about IVIG and what I know about COVID, again, we’re not experts in COVID. We’ve never designed or developed our products to treat an unknown respiratory pathogen like COVID-19. So what we do know about the virus is that the cytokine response that is triggered once a patient is infected is quite substantial. And just being that I’m a student of immune globulin for many, many years and the immune system, one of the unique mechanisms of actions of IVIG is the ability of the product and itself to just down regulate the cytokine storm, as they call it and as people may have heard on the news. So I think that it certainly makes sense to consider IVIG as a potential add-on to the existing standard of care that docs are using. IVIG supports the immune system. One interesting fact, Elliot, that we’ve uncovered and that we see in the data is that one out of every five COVID-19 infected patients is co-infected with some other respiratory pathogen. So I think that that speaks to the fact that these patients are not typically just infected with COVID. They may have some other underlying bacterial infection or viral…

Yes. Thanks. Then perhaps for Brian I guess with respect to the expense tied to production of BIVIGAM’s conformance batches in the quarter. Can that actually – did those conformance batches, can those actually be commercialized at some point and give you the ability to recover those costs or not?

Absolutely, Elliot, that’s a great question. I’m glad you brought it up. The capacity expansion that we’ve gone through for the conformance batches for this increased scale level, if you will, while we had to expense these production batches during this quarter, it’s in accordance to generally accepted accounting principles, these batches once we submit and receive FDA approval, we will be able to sell those batches at essentially 100% margin. So while we took the investment charge in the first quarter, there was multiple batches, let’s call it, we’ll be able to produce 100% margin later this year or sometime in the first half of 2021 depending on timing of FDA approval.

And if I can – Elliot, I just want to add. We used the term investments because, look, we understand the accounting rules, we understand where this has to go and we don’t want shareholders and our analysts to have tremendous concerns because the net loss was higher. What I can say is that we are investing into the infrastructure and ultimately we are going to have a better, stronger and have more control over our process to ensure that the forward-looking revenue generation opportunity and path to profitability is solidified for us after we make these continued investments. So we’re really proud of the work that we’ve done and we really hope that everyone sees this. As we are growing this business, we are not letting COVID stop us and we are pushing this forward to ensure that we can deliver the needed products to patients as we’ve seen demonstrated by this COVID-19 crisis. Plasma-derived antibodies are good and they save lives and we’re going to make more of them.

Sure. Just final question maybe considering the level of investment, just maybe detail the timeline and the remaining gaining factors before you can actually commence commercial production --?

With increased scale? Sure. So while I’m all excited that we’ve actually got an expanded process that will potentially double maybe even more our throughput capacity and while we have the ability now with fill finish machine in the building, that was so cool to watch them get a hole in the outside of the building and bring this thing in with this crane, it was great. You get to do a lot of fun things in my job. And I can tell you what we’ve said publicly in my talk is that we believe that we should have the applications to FDA filed in the second half of this year. So before December 31, we should have the appropriate applications on file. Again, depending upon the level of work, depending upon our conversations with FDA, I assume it’s going to be a prior approval supplement which can come with a four to six-month review time. But we are fairly confident that we should have these applications on file this year and that we would be commercial sometime during 2021 with product coming off the line with our increased production scale volume and fill finish capabilities coming from Boca Raton. So it’s a little early for us to give clear guidance on the timing, but we figure by the end of the year we should be on file with FDA and then we’ll let you guys estimate when FDA is going to have the time, effort, energy and bandwidth to review all of our applications. But we expect it should be sometime – the approvals in 2021.

All right. Thank you for taking the questions.

Thank you very much, Elliot. We appreciate it all.

Ladies and gentlemen, this will conclude our question-and-answer portion of the call. I’d like to turn it back over to Adam now for additional closing remarks.

Sure. I just want to say thank you everybody. Someone sent me a text. It is National Nurses Day, so we do want to thank all of our great nurses out there who help us. And look, we appreciate it and we look forward to keeping our investors and shareholders apprised of our growth and developments as they progress. Thanks for taking the time to listen to us today. And please everybody follow the rules of your government. Please stay healthy and safe and please go out and donate plasma and help us save lives. Take care, everybody.

Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation and you may now disconnect.