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Edited Transcript of ADMA earnings conference call or presentation 6-May-20 8:30pm GMT

Q1 2020 ADMA Biologics Inc Earnings Call

RAMSEY May 27, 2020 (Thomson StreetEvents) -- Edited Transcript of ADMA Biologics Inc earnings conference call or presentation Wednesday, May 6, 2020 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Adam S. Grossman

ADMA Biologics, Inc. - Co-Founder, President, CEO & Director

* Brian Lenz

ADMA Biologics, Inc. - Executive VP & CFO

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Conference Call Participants

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* Anthony Charles Petrone

Jefferies LLC, Research Division - Healthcare Analyst

* Elliot Henry Wilbur

Raymond James & Associates, Inc., Research Division - Senior Research Analyst

* Samuel Martin

Argot Partners, LLC - MD

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Presentation

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Operator [1]

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Good afternoon, and welcome to the ADMA Biologics First Quarter 2020 Financial Results Conference Call on Wednesday, May 6, year 2020. (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 2 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.

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Samuel Martin, Argot Partners, LLC - MD [2]

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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 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?

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [3]

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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 health care 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 CoVIg-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 specialist 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 option for COVID-19-infected patients.

The success of the CoVIg-19 alliance program leans heavily right now on the support of people across the world to donate plasma. We encourage those who have recovered from COVID-19, and who are interested in contributing to our development program or to any other company's development program, by donating their plasma. Even if you have not had COVID-19, your plasma is useful and is needed by many patients today. We encourage our fellow citizens to find a plasma center near you by visiting donatingplasma.org and donate your plasma to help save lives. All your plasma donations make a difference, and we thank you.

We at ADMA understand that patients are counting on us, and we must keep our commitments. With that said, we are very proud of the overall steadiness we experienced during the unforgettable first quarter of 2020, and we can report that there have been no significant impact to ADMA's operations or staff during this period due to the COVID-19 pandemic.

During the early part of 2020, 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. BIVIGAM and ASCENIV commercial launches continue to progress, and we, like other commercial companies, are implementing new programs and enhancing our virtual engagement offerings as we adapt in this evolving health care prescriber consumer environment.

Like many other drug companies, we have been experiencing certain impacts from the COVID-19 pandemic due to restrictions placed on travel, 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 health care 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 3 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 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, I'd like to take a moment to touch on a few noteworthy achievements and important activities completed so far in 2020. 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. We believe these projects are key to the future success of ADMA and are expected to enable the company to achieve profitability faster with a lower cost of goods, while enhancing the end-to-end control of our supply chain from raw material sourced plasma through testing, production, fill/finish and ultimately, final packaging. We are very proud to announce that during the quarter, we've taken delivery and had a new state-of-the-art aseptic filling machine installed in our facility in Boca Raton. Site acceptance testing has been completed, and validation qualification is well underway. This project currently remains on schedule, and we are hopeful to begin filling batches for potential FDA submission and review during the second half of 2020.

Another historic milestone the company achieved is the successful completion of conformance batch bulk drug substance production for BIVIGAM at an increased plasma pool scale. This increase to the plasma pool volume for BIVIGAM will allow us to produce more products faster and at a reduced cost, intended to accelerate the company's path to profitability. 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 by approximately 50% and potentially more. 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 sourced plasma used to produce our immunoglobulin products.

These 3 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, improving gross margins, providing more flexibility with and a reduction to batch production cycle time, which ultimately will give ADMA additional visibility and end-to-end control previously reserved for only the largest plasma fractionators.

Along with these primary supply chain activities and investments into the company's infrastructure, the company continues to improve other aspects of its operations, including our testing assays. During the quarter, we have been working to bring additional tests in-house and are identifying additional vendors to limit the number of sole source suppliers we work with across our operation. We are improving processes throughout the organization and are excited for the upcoming calendar quarters and keeping our shareholders apprised of our progress, growth and achievements.

In February, we strengthened the balance sheet through the successful completion of an underwritten public offering of ADMA's common stock, which resulted in net proceeds to the company of $88.7 million. This capital is important because it allows us to grow operations and execute on our 2020 stated objectives. We continue to procure the raw materials needed to manufacture BIVIGAM, ASCENIV and Nabi-HB; conduct the ongoing commercial rollout of our products; 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 Demski, 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 Chimerix as well as a Director at Adamas Pharmaceuticals and Equillium, Inc. 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 ASCENIV. We received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent extension application covering immunoglobulin plasma pool compositions used in the manufacturing of ASCENIV. The patent extension is expected to publish during the first half of 2020.

And finally, in early January, we entered into a 5-year manufacturing and supply agreement with a new customer to produce and sell plasma-derived intermediate fractions from our FDA-approved immune globulin manufacturing process. This agreement is expected to add approximately $5 million to $10 million per year in annual revenues for 2020 and 2021 and approximately $10 million to $20 million per year for 2022 through 2024. We are able to potentially recognize revenue from these intermediate fractions more rapidly than the typical production cycle seen with finished IVIG products.

And with that, I will now turn the call over to Brian for an overview of the first quarter financial highlights.

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Brian Lenz, ADMA Biologics, Inc. - Executive VP & CFO [4]

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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 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 a $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 is also attributed to higher selling, general and administrative expenses of $2.3 million. This is mainly due to increases in our commercialization efforts for BIVIGAM's relaunch and ASCENIV's launch, employee headcount compensation in addition to increased interest expense of $1.2 million, mainly due to accessing additional debt during the second quarter of 2019; along with higher research and development expenses of $400,000 related to a study we commenced for ASCENIV to potentially extend its approved and labeled expiration dating. Included in the net loss for the first quarter 2020 were noncash expenses of approximately $1.9 million for stock-based compensation, depreciation, amortization and noncash interest expense.

At March 31, 2020, ADMA had cash and cash equivalents of $101.2 million and accounts receivable of $7.1 million. And this is compared to cash and cash equivalents and accounts receivable of $26.8 million and $3.5 million, respectively, at December 31, 2019. ADMA's net working capital as of March 31, 2020, was $151.6 million, and that's compared to $71.8 million as of December 31, 2019.

As Adam mentioned earlier, in February 2020, we completed an underwritten public offering of approximately 27 million shares of our common stock at a public offering price of $3.50 per share which resulted in net proceeds of $88.7 million after deducting underwriting discounts, commissions and other operating expenses.

With that, I'll now turn the call back over to Adam for closing remarks.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [5]

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Thank you, Brian. The first quarter of 2020 demonstrated to me that our 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.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Your first question comes from the line of Anthony Petrone from Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Healthcare Analyst [2]

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Congratulations on the quarter. Maybe, Adam, I'll start with a few questions on the more recent trends. We're getting updates and -- from a number of companies just on how March -- trends in March were exiting in the last 2 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 side. Are you seeing any impacts in terms of scheduling for IG appointments and things like that? And then I'll have a few follow-ups.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [3]

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Sure. And Anthony, I can speak to ADMA and our operations, and then I can speak to some of the things that I hear through my participation at the PPTA Board level and just through conversations that I've had. First and foremost, ADMA -- I mean, we're 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 outs for our collectors. They have to manage the inventory themselves. So from ADMA's perspective, there's no impact to our raw material chain at this time.

With respect to IG, again, BIVIGAM, 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 are some other companies out there that have reported between 20% to 30% decline in collections. Now it varies. It varies upon region, it varies by collectors. 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 3- to 5-week period between March and maybe the beginning of April, where the industry saw a substantial decrease, this 20% to 30% decrease. However, it was for a very, very short finite period of time. And I actually listened to a conference call the other day from a company like Haemonetics, and they were saying how they're already seeing volumes come back to normal as early as mid-April.

So from my perspective, I think that there probably have been some patients that may have missed infusions during this March, April time cycle. I don't think that it significantly impacts BIVIGAM's utilization in any way, shape or form. But I have heard reports that there are some patients that have received approvals from payers for some subcutaneous IG administration. But overall, I don't believe that there's going to be a substantial disruption from this short downturn in collections. And in fact, if I carry it forward and if I use my crystal ball, Anthony, if we can rewind again to 2008 to 2009, when the economy was not healthy. If you go back and dig through some of the mainstream media news articles, there were pictures of people at plasma centers and the lines were wrapped around the block. I saw something this morning that the jobs report and the unemployment numbers, they are forecasting is going to be one of the worst ever. I hate to say that, that bodes well for plasma collection. But if people aren't working and if they're able to move around based on their local governments' rules and regulations due to COVID, I think that we could start seeing additional people who normally would not be doing anything.

And as well, I think you heard during my talk that there is a plea out there. I think because plasma and plasma donation is becoming more of a household conversation these days, at least in my house, it's certainly all the rage to talk about. But I think that what we're going to see is it used to be that altruism, and people were typically only giving out their blood altruistically. I think that we may see some outpouring of our society now looking at plasma donation differently. And I think that it really is a wonderful gift that we can give. It's giving the gift of life by donating plasma.

So I think all these things together, I think, ultimately, what we're going to see is a stronger plasma collection community, which ultimately is going to help support the tightness of IGIV supply that's out there, and that hasn't changed, Anthony.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Healthcare Analyst [4]

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And just 2 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 3 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 all are all fully in place?

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [5]

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Brian, since we're not in the same room today, can I -- I'll take the first part first?

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Brian Lenz, ADMA Biologics, Inc. - Executive VP & CFO [6]

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Absolutely.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [7]

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Sure. So Anthony, I can -- not to sound like a broken record, but plasma supply. 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 have been advocating for. So I think timing 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 the 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 in the alliance is also to support them through other scientific and advisory means. As you know, we are pretty knowledgeable with respect to microneutralization assays as they pertain to 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, know-how 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 then we do have certain know-how and technology that could be valuable in the development of a specific hyperimmune against COVID-19.

So hopefully, that answers your question. Brian?

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Brian Lenz, ADMA Biologics, Inc. - Executive VP & CFO [8]

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Thank you. Sure. Okay. Thank you for your question, Anthony, regarding working capital and cycle times. If we recall in our corporate presentation, we discussed the time frame it takes to manufacture one lot of an FDA-approved product, and that range is anywhere from 7 to 12 months. It could be longer. We view the investments that we've made here in the first quarter at 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 for improved margins, providing our products to market faster. This will also provide, obviously, improved inventory turns, 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 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 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 time frame of outlay of inventory to receiving cash from the sales like we would believe somewhere in maybe 2 to 3 months, could be even more.

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Operator [9]

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

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [10]

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First question for Adam. I guess with respect to BIVIGAM and ASCENIV, just in the context of COVID-19 and plasma therapies, which obviously have kind of moved front and center 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 sort of an emerging body of discussion regarding the use of traditional IVIG therapies in the treatment of COVID-19. And I know there's a couple of studies in China that have kicked off in recent weeks. There's one at Sharp Memorial in San Diego looking at open-label use of IVIG in ventilator-dependent COVID-19 patients. And then we've seen some recent case reports of this unusual sort of pediatric inflammatory condition being reported in New York City (inaudible). So it seems like there may potentially be a role for IVIG in the treatment of COVID-19. So 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.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [11]

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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 this is 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 in the immune system, one of the unique mechanisms of action of IVIG is the ability of the product in itself to just downregulate the cytokine storm, as they call it, and as people have may 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, Leland, that -- Elliot, I'm sorry, that we've uncovered and that we see in the data is that 1 out of every 5 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 infection. And that's where IVIG also because of its broad spectrum polyclonal antibodies, makes a lot of rational sense to use. But now let's talk about some of the other considerations that I think some of the medical emphasis and some of the P&T committees and medical directors at institutions are dealing with. There's a tightness of supply of IG already for the existing patients who need it in order to, if you will, live outside of the bubble or to live without certain types of chronic illnesses.

And I think that there is a shift where people are looking at this for some severely high-risk patients with COVID, maybe elderly population, those with comorbidities, diabetes, heart disease, other pulmonary conditions. But I think, overall, I think that there's more data that we need to see. I think ultimately, with any of these types of infectious diseases, you are going to see some IG being used in some institutions. And some institutions are not going to use IG. I do think that it certainly can't hurt. I think immune globulin supports the immune system of an ill patient, plain and simple. It downregulates the cytokine response. It supports and can help fight against any other bacterial or viral co-infection that patients may have. And ultimately, the drug is fairly safe if it's administered according to the labeled recommendation. So hopefully, that answers your question.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [12]

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Yes. And then perhaps for Brian, I guess, with respect to the expense tied to production of BIVIGAM conformance batches in the quarter. Can that actually -- do those conformance batches, can those actually be commercialized at some point and give you the ability to recover those costs? Or not?

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Brian Lenz, ADMA Biologics, Inc. - Executive VP & CFO [13]

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Absolutely, Elliot. That's a great -- Elliot, that's a great question. 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, those 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.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [14]

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And if I can, Elliot, I just want to add, we use the term investments because, look, we understand the accounting rules, and 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.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [15]

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Sure. And just one final question, maybe considering the level of investment, just maybe detail the time line and the remaining gating factors before you can actually commence commercial production.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [16]

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With the 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 kind of holding outside of the building and bring this thing in with this crane was great. You get to do a lot of fun things in my job.

And I can tell you that what we've said publicly in my talk is that we believe that we should have the applications to the FDA on file 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 the FDA, I assume it's going to be a prior approval supplement, which can come with a 4- to 6-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 you figure by the end of the year, we should be on file with the FDA. And then we'll let you guys estimate when FDA is going to have the time, effort, energy and bandwidth to review all our applications. But we expect it should be sometime, the approvals, in 2021.

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Operator [17]

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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.

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Adam S. Grossman, ADMA Biologics, Inc. - Co-Founder, President, CEO & Director [18]

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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.

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Operator [19]

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