Good afternoon, and welcome to the ADMA Biologics First Quarter 2022 Financial Results and Corporate Update Conference Call on Wednesday, May 11, 2022. At this time, all participants are in a listen-only mode. [Operator Instructions] 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 like to introduce Skyler Bloom, Senior Director of 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 first quarter 2022 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer; and Brian Lenz, Executive Vice President, Chief Financial Officer and General Manager 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 first quarter 2022 financial results. Finally, 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 2022 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.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 represents 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 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 2021 annual report on Form 10-K for the year ended December 31, 2021, as well as the risk factors section of our quarterly report on Form 10-Q for the quarter ended March 31, 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, Skyler. Good afternoon, everyone, and thank you for joining us on today's call. We hope you all remain healthy and safe. Our commercial performance and operational execution for ADMA’s intravenous immunoglobulin product portfolio has exceeded internal forecast and expectations. In the first quarter, we generated $29.1 million in total revenues, which translates to 81% growth compared to the first quarter of 2021, and continues the quarter-over-quarter growth as we advance towards profitability. The strong start to the year searches the basis for increasing our 2022 total revenue target to $130 million or more, upwardly revised from the previously provided target of $125 million. As we initially highlighted during last quarter’s call, the growth in our higher margin product portfolio notably with ASCENIV is exceeding our internal expectations and [canalizing] [ph] us to favorably rethink the products potential contribution within our overall product mix. In response to increased demand, during the first quarter of 2022, ADMA’s nimble manufacturing platform allowed us to shift our production priorities and increase our production schedule to include significantly more ASCENIV batches than previously planned for the first half of 2022. From a revenue perspective, we believe ASCENIV will now contribute at a level that we previously did not forecast materializing prior to the second half of 2023 and forward timeframe. We believe the accelerated ASCENIV adoption is being driven by ADMA’s successful product positioning, commercial messaging, and medical education campaigns, which are focused on expanding the brands awareness. As we approach the third-year of ASCENIV’s commercial availability, we believe from market feedback within the IG landscape that our organization and the ADMA Biologics name are now synonymous with the trust and confidence with physicians, providers, and patients. Additionally of note, we have seen the elevated demand trends for ASCENIV sustain throughout April and…

Thank you, Adam. We issued a press release earlier today, outlining our first quarter 2022 financial results, which I'll now discuss some of the key highlights. As Adam mentioned earlier, for the first quarter of 2022, total revenues were $29.1 million, compared to $16 million for the quarter ended March 31, 2021. And this represents an increase of approximately $13.1 million or 81%. The revenue growth for the first quarter of 2022, compared to the first quarter of 2021 was favorably impacted by the continued commercial successes and ramp up of our immune globulin product portfolio, including the expansion of our customer base for both ASCENIV and BIVIGAM. As a result of the encouraging early 2022 revenue growth trends, ADMA increased revenue guidance for its full-year 2022 to $130 million or more upwardly revised from the previous $125 million reported. During the first quarter of 2022, ADMA realized a positive gross margin of approximately 13%. This was driven by continued sales of our higher margin product and supply chain operating efficiencies, partially offset by an extended facility shutdown during the quarter. The company elected to extend the previously scheduled and otherwise routine shutdown at the Boca Raton manufacturing facility to complete certain projects which were forecasted for later in the year. Excluding these costs associated with the extended facility shutdown, the company estimates first quarter 2022 corporate gross margins would have been closer to 20% in a normalized production quarter. As certain of these shutdown activities and upgrades where one-time in nature, we anticipate the facility's production schedule will progress on a normal course over the balance of 2022 and beyond. Our consolidated net loss for the quarter-ended March 31, 2022 was $25 million or $0.13 per basic and diluted share. And this was compared to a consolidated net loss…

Thank you, Brian. In summary, all systems are firing in sync across departments and business units. We believe our company is well-positioned to generate best in industry top line revenue growth on a go forward basis. And in doing so, anticipates realizing significant operating leverage in the coming periods. Although we believe we are still in the early days of ASCENIV’s growth cycle, the reported real world experience and outcomes with the product and problematic and at risk immune deficient patients gives us confidence and the belief that the above expectation trends will prove durable and sustainable, which further solidifies our outlook for growing revenue and gross margin and the narrowing of net losses. With this in mind, we reiterate our previously provided financial guidance. Based upon current assumptions, supply chain and market conditions, we believe that ADMA is on track to generate $250 million in top line revenue in 2024 and $300 million or more annually thereafter. At this level, based upon current assumptions, we anticipate potentially achieving 40% to 50% corporate gross margins and 20% to 30% net income margins. Connecting the dots here, these assumptions translate into potential annual gross profit and net income of $100 million to $150 million and $50 million to $90 million respectively during the 2024, 2025 time period and beyond. From a cash funding perspective, as Brian detailed, we are well-capitalized, have good standing accounts receivables, and have the achieved the revenue milestones required to access an additional $25 million credit tranche, which we believe will provide for continued company-wide execution, as well as enable the ongoing and progressing exploration of strategic alternatives with Morgan Stanley from an improved position of strength. In closing, I'd like to thank you, our stockholders for your continued support as your investment in ADMA helps to advance our mission to save lives and make high quality safe and efficacious products that help our friends, family, and neighbors. Please donate plasma, help save others. And with that, we'll now open up the call for your questions. Thank you, operator.

Thank you, sir. [Operator Instructions] I show our first question comes from the line of Elliot Wilbur from Raymond James. Please go ahead.

Yes, thank you. Just a couple of quick ones upfront for Brian. Brian, could you just walk through the margin dynamics in the second quarter with respect to the favorable impact from longer dated inventory? Not sure I caught the subtle piece there, is this just a result of being able to sell some shorter dated inventory that you had previously expected to write-off or is it a reduction in accrual for potential eventual short-dated inventory? Just wasn't sure if I quite understood frankly the – factor driving the contribution there. And then I want to ask you an additional question as well, you call out the 1.3 million in expenses related to the ongoing strategic review process, just curious obviously at some point in time, I assume that ends, but how should we think about the cost progression there over the balance of the year? I mean these likely expenses that could continue through year-end, just trying to see if I can maybe tease out sort of the light at the end of the tunnel in terms of the cessation of spending there?

Sure. Good afternoon, Elliot. Thank for your questions. To begin with, the gross margin dynamics for the second quarter, that's going to be attributable to ASCENIV that we've sold, essentially already in the second quarter as part of product that we reserved for that was a result of the FDA extension of 24 months to 36 month shelf-life dating. So, not too long ago was, I think it was back in 2021, we reserved for a couple of lots at the 24 month dating that will allow us now to sell these lots at a 100% gross margin and will immediately recognize that revenue in the second quarter and the marginal will be as I mentioned, a 100% and that will certainly be accretive to revenues and add significant cash to the already well funded balance sheet.

Yes. Think of this Elliot maybe, the way we thought of the conformance batches when we were applying for FDA approval for BIVIGAM and ASCENIV, you could treat this inventory. And again they'll be recognized in the second quarter, roughly the same way. It is one-time in nature, but we're certainly proud of it and I think it speaks to the dedication of the whole admin team and the cooperation of the FDA, who we thank very much for granting us the approval, but the date is great. The product continues to remain stable and we're just very proud of having the products available now. And from a commercial standpoint, puts us at parity with all the other IGs on the market.

To put it in further context Elliot, we know that ASCENIV has a margins, one of our higher margin products at 80%. So, for the second quarter, this product will be realized at 100% gross margin. Your second question as it relates to the $1.3 million charge we incurred during the first quarter, we think about this charge as it relates to the strategic ongoing and progressing review process as a non-operational charge. So, when you think about expenses that we have as you're looking at strategic opportunities, you're going to see things such as legal, accounting, tax fees, it's certainly not a non – it’s not a core expense, but we expect to have these types of expenses to continue throughout the year. And again, the process is certainly progressing and I wouldn't say that the expenses are going to continue throughout the year.

So, maybe I could just add to that Elliot. I know those were questions for Brian, but just can't help myself. The business is evolving subsequent to commencing the Morgan Stanley process, as you heard in the prepared remarks, ASCENIV is truly gaining traction and penetration; BIVIGAM continues to build share, take share in the growing IG market, and we really are totally focused laser focus on the pathway to profitability. Certainly, what we just spoke about earlier, the ability to recognize a 100% margin on this ASCENIV product in the second quarter is a great win to our backs as we walk towards profitability, but the business is evolving. And I don't want to overs here, but we certainly are thinking that profitability timelines may be accelerated. In our view, this is truly transformative and profitability has never been clear. So, we are progressing with the Morgan Stanley process. As you see, we are spending on this process. Again these are expenses that we believe are going to continue. We don't know the timing of these expenses and I can tell you that these processes take on a life for their own. The buyers are all experiencing the same. I guess the parties I should say are experiencing all the same impact from the market that we are, but we can tell you that we're laser are focused on this. It's a top corporate priority and we are looking to conclude this. Our hope is, by the end of the year.

Thanks. And just one more if I may for yourself Adam as well. I mean, I think the story the last couple of quarters has been the strong performance of ASCENIV within the overall IDIG mix. And as you see more real world utilization of the product and growing position usage, I guess in various subtypes of PI patients, you know, how is this helping or how are you utilizing this real world data in terms of refining your overall marketing message? And I guess the question is basically, are you seeing more utilization in certain areas where you didn't think necessarily ASCENIV would be that favorably positioned and then you can, sort of use that as part of the feedback loop and go out and communicate the message to various prescribe or does the word, kind of spread within the physician community and then it makes its way back to the company. Just wondering how the real world utilization is sort of helping you to, sort of optimize your overall messaging around ASCENIV? Thanks.

Thanks for the question Elliot. It's a combination of factors. And I think first and foremost, we continue with our commercial messaging in our medical education strategy. We continue to present data at medical conferences all across the country, local shows, national shows, and conferences. And I think that the grassroots approach in the real world experience that has been published out there and that some of our KOLs have presented on is really starting to resonate amongst the tertiary clinicians, and their friends and colleagues. Patients are doing better on the product. These are patients again who've had problems, maybe they’ve switched brands of IG. They’ve tried to have their dose increase, which again, I've said on multiple calls that payers don't particularly like to do. So, a senate provides an alternative. Again, our patents and the differentiated methods by which we select and screen our plasma donors and then ultimately form the plasma pool is different, I mean it's patented. These patents run through 20, 35 time finish. And I can tell you that the patients are – problematic patients are going on ASCENIV and they're staying on the product. They're doing well. We're seeing less antibiotic use in this population. We're seeing less antiviral use in this population. We're seeing less other types of infection. So, it was designed to be an IG to be an alternative to what's available out there and quite frankly we really are proud of the work that our commercial organization has been doing. And I think that that translates into what you're seeing our revised upside revenue targets. This is durable. This is durable business and we're seeing, sure, we're opening up some new accounts, but what we're seeing is that the existing, I call it same store clinicians they're putting patients on therapy and they put the first one and the second line and they go through the reimbursement hurdles, which you have to do for any IG, and they're getting reimbursement and then they're seeing the outcomes, and then they're saying, you know what, I'm going to put patients three, four, and five on as well, they have similar risk factors. They have similar comorbidities. So, I think that's why we're seeing this acceleration occurring so quickly is that people see that the drug works and candidly the supply is available. And I think that that also is something that, while our plant has been here for a while, ADMA is still considered “newcomer” into the IG space, and in my prepared comments, it was purposeful, I really believe that ADMA is building a name for itself as a reliable durable supplier. You see our inventory is approximately 140 million. Our customers see that we've got the continuity of supply and they can ensure the continuity of care to their patients. And that is really what is driving this. So, hopefully that answers your question.

Thank you. I show our next question comes from the line of Kristen Kluska from Cantor Fitzgerald. Please go ahead.

Hi, Kristen.

Hi. Good afternoon everybody. Thanks so much for taking the questions and congrats on another strong quarter. I just wanted to pick your brain and ask a little bit more about how you're valuing the company based on the facility itself, the machinery, and the space? I know in the past you've spoken pretty highly about real estate and things in Boca, but just, how do you think that this has changed in-light of inflation and forecast and everything that we've seen in the sector across this last year?

Well, Kristen, thank you for the question. I think our visibility from a valuation standpoint remains extremely high. Our core financial performance as you also indicated continues to improve. When we look at our balance sheet with regards to our property plan equipment, our plasma centers that were successfully building out on an accelerated basis, all that valuation, I think really translates to our balance sheet growing from 276 million at the end of the year, just a few short months ago, to now over $308 million. Our inventory at $139 million, which is really the level that's right sized to support our ongoing upward revised revenue guidance, as well as all of our raw material on RSV, and normal source plasma requirements. It's really – this has been the single largest use of cash through the first two years of commercialization ramp up. And we expect our inventory really to be plateauing from here as really a highly favorable dynamic for the business going forward, which in other words just to say, we anticipate our cash burn to continue to decline with net losses narrowing. One other thing to thing to think about, couple of the things to think about with this quarter that I wanted to make sure it was clear to everybody, while we had a $25 million net loss, there were a couple of non-recurring and non-operational charges, as I mentioned earlier, $6.7 million from the early discharge of debt, that's a one-time charge. We have non-operational charges of 1.3 million related to professional services fees, non-cash non-recurring charges of $500,000. And then as I mentioned, we had a plant maintenance extended shutdown in the press release, which would essentially take – taken our gross margin from 13% that we saw this quarter to 20% gross margin. And that equates to, if you factor all those one-time charges and non-operational charges and the improved gross margin, we have a net loss of about $14 million, which is certainly meaningful from a narrowing quarter-over-quarter and year-over-year standpoint. So, we're committed to building the company gross profits, narrowing net losses over the remainder of 2022 and beyond. So, we feel very confident going forward.

And if I may, Kristen, real estate and Boca, I keep getting all these emails about the properties for sale. I mean the prices just keep going up, it’s, I don't know how long it can continue, but real estate and Boca are still thriving, but I think it's important to look at, I mean, look, our facilities FDA approve, we passed our inspections, we've got everything from end-to-end on campus here. Feel finish, everything is working well and we really feel very proud of our end-to-end control, but when you really look at the asset value here, I think a lot of it has to do with how much cash can we generate, how much revenue can we generate out of this facility? And I got to tell you, every week, my staff continues to amaze me about the efficiency improvements that we're unlocking and we're seeing improvements to yield on particular batches, and we're just getting more comfortable with this operation. So, I really think that when we look at the potential upside, that's why we reiterated our previously provided financial guidance. And after 2024, we say $300 million or more. I mean, we really think that there's upside here to our forecast. We feel very comfortable about the guidance that we're giving. I think that hopefully our stockholders and the Street and our analysts understand, you know Brian and I are, we like to hit our milestone. We like to keep our promises. We still feel very, very good about our track record of hitting regulatory, and commercial milestones here, but ASCENIV is presenting a tremendous upside. We said during the call that we – our manufacturing platform is so nimble that we were able to say, you know what, we're looking at demand for ASCENIV growing, and we're swapping out BIVIGAM batches for ASCENIV batches. It's the same. As Skyler likes to say, it's the same squeeze, but for a lot more juice from a revenue perspective and a margin perspective where BIVIGAM is a 20% to 30% gross margin product and our higher margin portfolio ASCENIV and [indiscernible] are in the 70% to 80% plus gross margin perspective. So, we're really thinking that the asset value here and the amount of cash that we can generate has upside to the forecast that we're presenting. So, long answer to your question, but very proud of the work, especially in-light of the current backdrop.

Okay, great. Thanks. And Brian, maybe I can hone in a little bit more on this point on inventory that you brought up. So, you noted nearing [plateau] [ph]. So, I guess if you could be a little bit more specific about how to think about this in the shorter-term horizon as you are nearing potential profitability?

Sure. So, what we've said historically, when you're thinking about gross margins, we obviously want to have the right level of inventory to generate the $250 million to $300 million or more in revenues. At a $139 million in total inventory, if you're looking at a 40% or 50% gross margin, clearly you can see, we can do an excess or excess of $250 million or commercial value of $250 million or more once we've gone through the WIP and finished goods process. So, as I said, we've upward revised revenue guidance to $300 million. We feel very confident that $139 million is the right size. It may fluctuate from time-to-time, quarter-to-quarter, maybe modestly go up a little bit as we look to exceed the $250 million to $300 million in revenue, but we really think that the largest – previously the largest single use of cash utilization was inventory and we've built that inventory balance to a very well-funded number.

Okay, thanks. And a question on ASCENIV, just in-light of your comments and your enthusiasm that you've seen over these past few quarters, wanted to ask if you could provide any more color and I know it's still very much early days, just about the number of average number of doses that you're seeing being utilized with ASCENIV?

Kristen, it's a great question, and I can tell you that the primary immune deficient population, they use IG every three to four week, and we're seeing these patients receive product. We have patients on therapy for – they're in their second year of therapy. This is a change to our forecast. I mean, maybe that's a great – maybe I didn't answer that question that Elliott asked earlier. I mean, I think that that's a change to our internal forecast. We didn't necessarily forecast that patients were going to remain on ASCENIV for the duration of the entire calendar year, but clinicians and patients don't like to change IGs if there's no reason to. If a patient is doing well on an existing therapy, the desire is to keep the patient on that therapy. So, I think that it's again still early, but we feel that these trends are proving durable because we're seeing this now quarter-over-quarter. And really in the primary immune deficient patient, which is where we focus our efforts, our marketing and our medical education efforts are all around the immune compromised. These are patients who are receiving therapy every three to four months and again, patients are staying on therapy as their primary brand of IVIG.

Okay. Thanks. And last question for me, it's definitely something I've asked you before, but I'm going to ask it again in-light of all the comments you've made here around ASCENIV. So, just in light of this high-demand, you know the great feedback, what additional measures are you looking to take at this place to secure even more of this plasma from the particular donors that have the sufficient levels of neutralizing antibody to RSV?

That's a great question. It's actually quite time whether you're asking that question, whether I should be saying, and I saw Microsoft Teams message that I came across my desk today saying, hey, one of our vendors will extend our contract if we agree to some of these terms. And I said, hell yeah, let's extend the contract. So, we're doing everything from extending contracts to speak to my analytical development and scientific team in building two across the way here on our Boca campus. We made investments into equipment and we're bringing parts of our RSV neutralization assay in-house. This is going to allow us to optimize turnaround times of identifying donors and we think that that's ultimately going to help us to capture these plasma donors faster in their donor life cycle process, whether it be from one of our third party vendors or from one of our own centers. As you know, Kristen, in my statements and Brian’s statements, we've got five centers that are approved today. We've got seven centers collecting. I think we've currently said, approximately 5% to 10% of donors have the antibody titers that we're looking for to use in the plasma pool for ASCENIV and a typical plasma center pre-pandemic, which we are certainly seeing improvements to our own collections from a foot-traffic perspective, as well as the yields from the Haemonetics’ Persona system which are continuing to exceed our expectations. We've got plenty in plasma. I mean, we've got, I was on the phone with some shareholders a couple of weeks ago, and I was reiterating to them, you know ADMA has never had a plasma problem throughout the entire pandemic. We continue to be very long plasma both normal source and RSV plasma. And we are taking measures to expedite the identification of these donors by bringing some of the testing in-house, extending our supply contracts, and I should reiterate that our Grifols agreement for collecting RSV plasma, which has really been the primary supply source for the product since our company's inception that agreement runs through June of 2027. So, we've got a long-term there. We've got more collection centers under our corporate umbrella than ever before. And I'm very pleased to say that our BioCenters business unit is operating very efficiently. Our collections are within budgetary targets or exceeding and we really are very proud of our plasma position. We've got plenty of plasma, plenty, plenty of plasma.

Awesome. Thanks again for taking the questions.

Thank you so much.

Thank you. 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.

Well, thank you everybody for dialing in today. Hang in there. And I'd like to thank everyone for all of their continued support for the hard work of the ADMA Biologics team and to my team. Thank you for listening. Let's keep making some good high quality batches. Take care everybody.

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