ADMA Biologics (NASDAQ:ADMA) Q2 2021 Earnings Call

0:00 Good afternoon and welcome to ADMA Biologics' second quarter 2021 financial results and corporate update conference call on Wednesday, August 11, 2021. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call. At this time, I would like to introduce Skyler Bloom, Director, Investor Relations, and Corporate Strategy at ADMA Biologics. Please go ahead.

0:48 Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the second quarter of 2021 and recent corporate updates. 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 an update on corporate progress, and then Brian will provide an overview of the company's second quarter 2021 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the second quarter 2021 financial results and summarize certain second quarter achievements in recent corporate updates. The release is available on our website at www.admobiologics.com.

1:36 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.

2:28 We refer you to the disclosure notice section in our earnings release we issued today in the risk factors section of our 2020 annual report on Form 10-K and our quarterly report on Form 10-Q for the second quarter ended June 30, 2021, for discussion of important factors that could cause actual results to differ materially from these forward-looking statements.

2:53 Thank you, Skyler. Good afternoon, everyone, and thank you for joining us on today's call. We hope those joining us today remain healthy and safe. ADMA continues to excel with the commercial launch and revenue ramp-up of its immunoglobulin and hyperimmune globulin product portfolio, as well as, more broadly, advancing our company's strategic goals to create value for stockholders in the periods to come. The underlying business trends for our commercial immune globulin business have never been stronger and the operational execution by our organization across business segments cannot be overstated. The significant strides made during the first half of 2021 form the foundation for continued quarter over quarter revenue growth over the remainder of the year and thereafter.

3:43 The totality of our achievements to date will enable ADMA to enter the next phase of its profit-oriented growth strategy from a position of strength. The multi-year investment and remediation initiatives will be successfully winding down with the anticipated approval of the Vanarex aseptic fill finish machine over the coming months. And as a result, the company is now on the precipice of realizing significant operating leverage on its pathway to corporate profitability. During the second quarter of 2021, ADMA exceeded analyst consensus top-line revenue forecasts for the fourth consecutive quarter, generating record quarterly revenues of $17.8 million, representing a 129% growth rate compared to the second quarter of 2020.

4:38 Additionally, the company successfully narrowed gross and net losses year over year, A trend ADMA believes can continue in the coming quarters and further accelerate throughout 2022. While ADMA's revenue and execution of its business plan have seen record and favorable results over the past several quarters, it is important to highlight that pandemic-related headwinds have impacted and continue to impact ADMA's commercial launch phase. Further, these record second quarter financial results do not yet reflect the added benefits expected from the recent FDA approval of our 4,400-liter expanded IVIG production scale, the additional plasma center developments, including opening a new plasma center and implementing the new PERSONA donor collection software, nor includes the operating efficiencies expected from the anticipated VanRX approval over the coming months.

5:42 We expect these approvals and enhancements to act as significant tailwinds for our business over the remainder of 2021 and beyond. Said another way, through unprecedented adversity, ADMA is just beginning to scratch the surface of the ultimate financial and value potential we believe this asset-based and biologic drug manufacturing organization is now able to support. We expect the supply chain milestones achieved thus far in 2021 will result in greater product yields and cost of goods sold improvements to support both near-term and ongoing financial results. And importantly, they will set the stage for durable value creation and continued narrowing of both gross and net losses over the longer term.

6:34 The recent achievement of FDA finding no form 483 observations as part of the pre-approval inspection for the Vanarex aseptic fill finish machine should pave the way for an anticipated approval over the coming months. When approved, the licensure of the Vanarex machine will cap a successful multi-year remediation process and supply chain investment initiative at the Boca Raton, Florida manufacturing facility. propelling ADMA into an elite group of U.S.-based drug manufacturers with comprehensive in-house control of a majority of its critical manufacturing functions. The COVID-19 pandemic has illuminated high-profile vulnerabilities in pharmaceutical supply chains among our large and mid-sized peers.

7:26 And it is in this context that we believe the successful remediation of our manufacturing operations Establishment of end-to-end supply chain control and ADMA's continued commitment to CGMP compliance uniquely differentiates our manufacturing footprint and is a testament to our industry-leading regulatory, quality, and operational personnel. In addition to recently revising the plant's annual peak production capacity up to 600,000 liters, as well as increasing peak revenue guidance, To $300 million or more, ADMA will actively explore new contract manufacturing opportunities following the anticipated approval of the VanRX machine in the second half of 2021, which could add additional revenue sources presently uncontemplated in the company's current financial targets.

8:22 We intend to provide updates to these financial objectives and communicate developments to the market as appropriate over the coming months. Ensuring uninterrupted raw material plasma supply has been a strategic priority and investment focus for ADMA prior to and throughout the COVID-19 pandemic. Industry-wide headwinds pressuring plasma collection remain intact and are likely to sustain due to recent U.S. government policy restrictions pertaining to the U.S.-Mexico border and plasma collection facilities, among other variables. Accordingly, We believe the 2021 year-to-date milestones achieved by our ADMA Biocenters business unit will yield significant results and largely insulate the company from broader market plasma collection and pricing fluctuations in the periods ahead.

9:18 Most notably, the first half of 2021 can be defined by three overarching achievements for ADMA Biocenters segment and ongoing raw materials supply. One, The implementation of Humanetics Persona technology across our Plasma Collection Center network, which is expected to enhance collection yield by approximately 8%. Two, the extension of our company's principal third-party plasma supply contract through year-end 2022. And three, the continued on-track expansion of the BioCenters Plasma Collection Center network, which now includes eight centers in various stages of approval and development. collectively, the benefits of these three elements establish a solid foundation for ADMA to ensure continuity of product supply into an increasingly supply-constrained immune globulin market.

10:15 ADMA's robust inventories of approximately $100 million at the end of the second quarter further validates the company's commitment to generate quarter-over-quarter revenue growth throughout 2021 and beyond. Adam Grossman, Brad Tade, John Hafl of our company's immune globulin and hyperimmune globulin products portfolio.

11:03 ADMA has established a strong foundation to continue to penetrate the rapidly growing US immune globulin market, which reached approximately 9.5 billion in total revenues in 2020, up approximately 19% year over year. With ADMA's commercial portfolio now annualizing more than $71 million in top line sales, Thank you for joining us. We believe there may be opportunities to formally revisit the company's current top-line revenue and profitability guidance as the year progresses and anticipated regulatory events unfold.

12:02 The evaluation of these targets is ongoing, and we look forward to communicating more in the periods ahead. We would like to thank the ADMA Biologics team for keeping its focus and continuing to execute. Producing biologics is a very complex process, with many constituents throughout the supply chain and I commend you all for meeting our top goal, delivering for the patients who are counting us. Additionally, we are sincerely grateful to our stockholders for their continued support of our efforts to provide life-saving products to patients in need. With that said, I'd now like to turn the call over to Brian for a review of the second quarter 2021 financials. Thank you, Adam.

12:45 Since we issued a press release earlier today outlining our second quarter 2021 financial results, I'll just review some of the highlights. For the second quarter of 2021, total revenues were $17.8 million compared to $7.8 million for the second quarter of 2020. And this represents an increase of $10 million or approximately 129%. The revenue growth for the second quarter of 2021 compared to the second quarter of 2020 was favorably impacted by the continued commercial ramp up of our IVIG product portfolio and expanding customer base at both our Biocenters Plasma Collection segment as well as in our Biomanufacturing segment. Additionally, ADMA grew its total asset base to a quarter-end balance of approximately $232.8 million, which includes approximately $100 million in inventory.

13:39 ADMA expects the robust inventories which are recorded at the company's cost to support quarter-over-quarter revenue growth throughout 2021 and beyond. as well as meet the production needs to achieve longer term revenue guidance of $300 million or more. This inventory balance consists of raw materials including source plasma and other materials expected to be used in the production as well as work in process and finished goods inventories comprised of our commercial IVIG products and intermediate fractions. In the periods ahead, ADMA anticipates continuing to purchase raw materials while also growing its internal plasma collection center network, building work and process inventories, as well as finished goods inventories.

14:25 Given the ongoing industry plasma collection constraints, as Adam previously characterized, we intend to retain a portion of our growing inventories as safety stock, which we believe will help solidify our emerging position as a reliable supplier to our customers, distribution partners, and prescribers over the coming quarters. Our consolidated net loss for the second quarter of 2021 was approximately $18.9 million or a $0.15 loss per basic undiluted share compared to a consolidated net loss of approximately $20.2 million or a $0.23 loss per basic undiluted share for the second quarter of 2020. The decrease in year-over-year net loss was primarily attributable to increased revenues and improved gross margins.

15:11 With this being the fourth consecutive quarter of revenue growth, We anticipate this trend to continue in the periods ahead. With that, I will now turn the call back over to Adam for closing remarks.

15:23 Thank you, Brian. Within two years following FDA approval of Ascenev and Bivigan, ADMA has successfully established end-to-end control of its manufacturing chain, and while doing so, has also built a high-caliber commercial organization well-positioned to compete in the rapidly growing U.S. immune globulin market. This market is expected to reach approximately $17.2 billion in annual revenues by 2027. ADMA's 2021 year-to-date accomplishments across business segments will enable the company to accelerate robust financial trends in the period ahead and enter the next phase of what we believe will be a multi-decade, profit-oriented lifecycle opportunity.

16:12 In the short term, We now anticipate exiting 2021 with an annualized revenue run rate of approximately $100 million or more. Additionally, and as communicated in prior calls, we as a management team and board of directors have invested significant capital into the company, and we are acutely aware of the valuation disconnect between ADMA's appreciating intrinsic value and the company's current market cap. We are aligned with you, our stockholders. As such, we are considering alternative business opportunities to maximize stockholder value, including, for example, the acquisition or sale of specific assets or businesses, collaboration and or license agreements, or other co-development agreements or arrangements.

17:05 We look forward to a strong remainder of 2021 and the bright future for ADMA Biologics. 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, make good, efficacious, safe products that help our friends, family, and neighbors. Please donate plasma and help save lives. And with that, I'd now like to open up the call for your questions. And thank you. As a reminder to ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from Anthony Patron from Jefferies.

17:54 Your line is now open.

17:57 Thanks. Good afternoon, everyone. Congratulations on another strong 2Q here. Thanks, Anthony. I'm going to start with the 100 million target Exiting this year, just wondering what the mix of Bivigam, Nobby, and Ascentive is in there. So that would be the first question. And then on the disclosure here on the CDMO arrangements, when we think about the plant in VOCA eventually getting to an operational capacity of 600,000 liters, what should we be thinking about in terms of Allocation to Future Potential CDMO Agreements, and I'll have a couple of follow-ups.

18:43 Sure. Thanks, Anthony. Thanks for your kind words. Hope you're staying safe up there in New York. So, yeah, we're, you know, it's a great time to be in the immune globulin business. I think that, you know, you stay on top of current events with the collection segment as well as how that flows through to finished goods and A number of our competitors, large, midsize, and the smaller players, they're not taking on new customers right now. They're talking about having tightness of supply anticipated later this year, early next year. We're hearing that there are substantial countries in Europe, in the EU, that are truly undersupplied at the present time. And I'm not sure how much longer The competitors are able to take product from one country and bring it into the U.S.

19:38 So the outlook for our revenue growth really looks very, very strong. Again, we've got more product in the supply chain and coming online than we've ever had before. And regarding your question about the 100 million potential run rate that we would be achieving later this year, as we've Previously said to you and others and on these calls, our current mix is pretty much 90-10, 80-20 right now, Bivigam being the majority of the product that we are producing and distributing and selling out of this plant. We are seeing growth in our hyperimmune product segment. Utilization of Nobby and the press release earlier this week regarding now having the 1ml size back on the market certainly is welcome to our customers.

20:35 So we're very, very excited there and we hope to gain some more market share back since we haven't had the 1ml product on the market for a while. And Ascentive is growing at a steady pace both in the outpatient and the inpatient segment. We feel very, very confident that the J-code has really helped to bolster and solidify reimbursement in multiple treatment settings. And we're just very proud of the work that we're doing and the acceptance of our products. Again, we've got more product available, and we are taking new customers. We are adding people to our distribution network. We are selling through distributors and pulling it through.

21:20 And we are also adding new specialty pharmacies, hospitals, home care organizations all the time. So really, things are going very well for us from a commercial standpoint. I think your next question was around capacity. Again, it's going to take us a little while to get up to the 600,000 liter capacity. You know, what we do say is that Within three, four years or so, we should be able to generate revenues of, we say, $250 million or more in 2024 and then potentially generating more thereafter. It's probably going to take us 2024, 2025 to get to really that 600,000 liter capacity, Anthony.

22:07 We're currently expanding our ADMA BioCenters business segment. I'm sure you saw that press release yesterday. yesterday after market. And we're really very proud of the work that's being accomplished there. And you take our vertically integrated plasma collection coupled with our third-party supply agreements and some new contracts that are going to come online later this year and next year, and we reiterate all previously stated financial and strategic objectives with respect to quarter-over-quarter revenue growth. and we anticipate that's going to continue all the way through profitability forecasted for Q1 2024. Hopefully that answers your question. You got something?

22:49 Sure. And I could add a little bit more color to the revenue mix, Anthony. As we saw in this quarter, actually, compared to the first quarter of 21, we had a negative 11% gross margin. Actually, that number's been cut in half now to a negative 6% gross margin. And that's really attributable to selling more of our hyperimmune globulin products. That product mix is already starting to see a shift. The hyperimmune globulins, as we mentioned previously, have a 70% to 80% gross margin, and our standard IVIG product globulins have a gross margin of 20% to 30%. We've already started seeing that product mix really start in the second quarter. We think that that's going to continue that trend. We've also, in this quarter, as a result of the increased revenues, we've seen more customers that have been added. We've expanded our customer base.

23:41 and again, we're selling more of our hyperimmune products into the market and they're being well received.

23:47 That's helpful. And a couple of follow-ups here would be, one, just to reiterate on the plasma collection side, you're at eight, in the process of getting to the eight centers. I just want to confirm that exiting 2022, the target is still for 10 operational centers. So that would be the first question. And then secondly, just as you speak to inventories, and you mentioned safety stock. Maybe what should we be thinking of as we look at the inventory going forward? What percent of your balances will be represented by safety stock? Thanks again and congrats again on the quarter.

24:27 Sure. Okay. I'll take those questions. With regards to the centers, we currently do have eight centers in various stages of development. Two are FDA approved. Five centers are collecting Plasma at present. By the end of 2022, we want to have 10 centers or more under our corporate umbrella. By 2024, we'd like to have all those 10 centers or more FDA approved. And really, being in a place where we'll be self-sufficient to bring in, from a supply chain standpoint, the majority, if not all of our raw materials, 400 to maybe 600,000 liters of plasma coming in from our plasma centers. Now, as you look at our inventories, ending the second quarter of 2021, we have $100 million in inventory.

25:16 And half of that inventory, and this is a testament to show how much production we've really been able to ramp up here in Boca. Our work in process is close to $50 million. And that's a testament to show how much The production has continued to increase here. We just got the 4,400 approval process approved by the FDA just in April. So we think that that WIP number is going to continue to grow, which is a good sign because as that WIP number, work and process number, moves through the manufacturing and filling phase of our seven to 12-month production lifecycle, a lot of that product is then going to go into the final phase, the finish good phase. So to answer your question roughly, How much finished goods would we estimate to have on a quarterly basis?

26:05 Since we've got it to $250 million, Anthony, in 2024, and we say roughly a blended margin of about 50%, on a quarterly basis, you're looking at somewhere between $60 and $70 million a quarter at 50% gross margin. I think it's somewhere around $30 to $40 million, and it's at our cost, of finished goods. So we're certainly well on our way having a balance sheet of $100 million in inventory at our cost, thinking, again, about 50% gross margin on that number. We're certainly setting ourselves up for a very strong foundation that we've created to achieve quarter-over-quarter, year-over-year revenue growth, again, which is a testament to these recently published financials for our second quarter. Thanks again. Thank you.

26:51 Thank you. And our next question comes from Elliot Wilbur. from Raymond James. Your line is now open.

26:57 Thanks. Good afternoon. First question for Brian, maybe just following up on some of your commentary around COGS and inventory, specifically thinking about the COGS line, always a lot of questions when you have negative margins. But just trying to think about how this line progresses or changes going forward as your top line increases. I guess if I look at second quarter revenue went up sequentially around 1.8 million, COGS went up around 1 million. Is that how we're going to see things progress going forward? Basically, you know, you're going to start to see 40, 50% incremental margin per incremental revenue dollar on top of sort of the average COGS run rate we've seen in the last quarter.

27:45 Just trying to figure out how exactly that number is going to trend as sales continue to accelerate.

27:51 Sure. Thanks for the question, Elliot. So a couple of things with COGS. When we achieve the $250 million run rate from a revenue standpoint in 2024, we'll essentially be at very close to full capacity production, 90%, 100% capacity production, producing that much product to get to that level. We're certainly not there yet. So we currently do have some unabsorbed manufacturing overhead costs that are still in the cost of product revenue line. But as we continue to scale up operations, most importantly, as I mentioned about the 4,400 scale up, as we continue to produce more Bibigam at the 4,400 liter, more product, more margins are going to be improved to essentially generate those additional revenues. So when you think about the main variable cost going from a 2,200 to a 4,400 liter batch is just the raw material.

28:46 Not a very small, modest amount of additional direct labor, but the overhead is essentially the same. So revenues, to put it simplistically, will be outpacing the overall COGS number in the not too distant future. Number one, because of the 4,400 liter batches we're producing now that we're going to be releasing next year. Number two, the second half of this year, we have The four 4,400-liter batches, the conformance batches that we manufactured previously once we got the FDA approval just this past April a couple months ago, we hope to expect to be selling those batches in the second half of this year. So you'll see margins continue to improve there. And again, just thinking about the lifecycle timeframe of 4,400-liter production, it'll take seven to 12 months. So we're going to start realizing some of those synergies, cost efficiencies, margin improvement, as we've seen this quarter from the previous quarter, We expect those trends to continue the second half of this year and certainly accelerating into the first half of 2022.

29:47 I also think, Elliot, if I can just add something. Something else to take note of is that with any drug manufacturing, and I think in the comments, Brian and I have both said that producing biologics is certainly complicated, complex, and not the easiest thing in the world, but There's always the possibility of some one-time, one-off charges and expenses. And they're unpredictable. And these are just things that it's hard for us to guide you as an analyst and others, but I think that as we continue to produce more, the effects of maybe some of these discrepancies and one-off occurrences could be less meaningful. Additionally, I think with The pandemic and certain issues regarding supply chain, raw materials, disposables, consumables, testing reagents, et cetera, other supplies.

30:50 There are some costs, shipping charges, one-time expenses. I mean, honestly, I'm sure I don't have to really say these types of things, but you need to get a truck delivered with ethanol, but there's no driver. But you may have to offer the driver an extra five grand to get in the truck to come down here to drive it to you. I mean, there are some very interesting things that are going on across industries with the supply chain that, you know, they're just unpredictable right now. But to Brian's point, we expect revenues to continue to increase. The product mix is certainly improving. The acceptance of our hyperimmunes is growing. And I think that, you know, as we've reported previously, The margins on our hyperimmune products are typically call it 60% to 80% gross margin product. The more of those that we can sell, the better our overall cogs are going to be as an operating business unit in the biomanufacturing segment.

31:57 Thanks. Adam, if I can ask you a question as well. Historically, Navi has been a relatively steady product, but Can you speak to any factors that might be driving marginally increased demand there? And similar question on incentive. What may be driving the incremental volume there? Is it just overall demand for IVIG and then there's capacity constraints or is it more specifically tied to Thank you very much.

32:55 Thank you for joining us. You know, there are some other factors, I think. You know, people are still hunkering down, and cohabitation with other people with hepatitis certainly is a labeled, indicated use for the drug. And quite frankly, I think awareness, maybe some of the marketing programs and some of the campaigns that we spent money on and invested on, I like to think that they're working.

33:48 You know, with respect to Ascentive, you know, As you know, what differentiates Ascentive from Bivigam and from other immune globulins on the market is our patented methods of how we identify and screen plasma donors. And we collect from donors who are tested to have high levels of neutralizing antibodies to respiratory syncytial virus. And our patents state that these donors also seem to have High antibody levels to a panel of other respiratory viral pathogens. And, you know, I cannot explain it. It defies everything that I've ever learned throughout my 25-year career in the RSV immune globulin space.

34:36 But global awareness of RSV is heightened. The CDC put out some guidelines a couple of months ago, at least for the southeast region of the United States, that RSV is on high alert. And we're seeing an increased rate of RSV infections in advance of what's typically the normal and customary RSV season. So, you know, the drug also in an outpatient setting, I mean, look, when you look at, again, when you visit the Ascendant website, we talk about patients that are suffering from chronic and persistent bacterial viral infections. They may be on concurrent antibiotic therapy and receiving other drugs there.

35:22 I mean, I think our commercial team and the investments that we've made into the commercial launch, both through the face-to-face approach, the virtual congresses, the websites, the media campaigns, everything that we've done. I mean, we've made a significant investment into the launch of this product. Again, getting the J code and solidifying reimbursement I think helps but I think that we're starting to see a good return on our investments that we've made. Something that I talk about and I mentioned it in my prepared remarks today is we do a lot of things here at ADMA and one of the things that we do is we've built an entire commercial organization to support our three commercial products and we've got A stellar sales force, a stellar national accounts team.

36:16 We've got some of the leading market access and reimbursement folks. And, you know, I'm proud of where these people have cut their teeth and come from, and now they're bringing their expertise to Adma Biologics. They're able to flourish here. And I think that, you know, I take my hat off to this team. It hasn't been easy. It's been a challenge during COVID and the pandemic to – engage with clinicians. And let's just say when the country opened up this past summer, you know, late spring, early summer when things were opening up, our team pushed me to resume traveling. They were some of the first to get vaccinated and they've been pounding the pavement and I'm seeing the expense reports coming through.

37:04 So we're starting to see some Hospital closures, we're starting to see hospital beds fill up and we're hearing, reading the articles that I'm sure you are as well. But I think it's all a mix of, you know, the chaos that is stemming from the pandemic. You know, immune globulin is what you use to prevent or treat certain infectious diseases in immune compromised people. Remember, immune compromised patients typically don't respond well to vaccines. So be it an influenza vaccine, an RSV vaccine. We know that there are trials that are ongoing. The COVID vaccine and all the other normal and customary vaccines. I mean, that's the purpose of immune globulin is to provide passive immunity to infectious pathogens. So I think it's all coming together.

37:56 And, you know, I say it. but I really do mean it. It's not a bad time to be in the immune globulin business. We continue to receive inbound phone calls and our sales force follows up with them. We're taking on new customers and we're really proud of it. The supply chain cycle, there's There's improvements anticipated with the upcoming potential approval of the Banner X machine and us taking control in-house. But you're never gonna really speed it up faster than that seven, eight, nine, 10 month timeframe. That's how long it takes to make these drugs.

38:42 And you gotta think about it like gestating a baby. Sometimes they come a little quicker, sometimes they take a little longer, but most of the time, you're looking at nine months. You can accelerate this process. So, you know, we appreciate our shareholders' patience as we continue to grow and build our manufacturing throughput, as we secure our plasma supply. But at the end of the day, we really want people to feel confident that we've got an excellent commercial team leading the charge out there. They're putting the product into the channel and they're pulling it through. The utilization is there. The reimbursement is there. and all of this is coming together and I think with our revised guidance that we put out this quarter where we anticipate the potential to exit this year with a $100 million revenue run rate and that's only going to grow as we proceed through 2022. I mean Brian and I can't be more bullish on the amount of finished goods that we're going to be able to provide to the market and We want the patient community and the patient advocacy community to know that if you have a problem obtaining IG from your standard supplier, we're here and we've got grams available.

39:55 Thanks. And one last question, if I may. Can you just talk a little bit about the 100 ml vial offering, how important that is to expanding the franchise? I know it's available in limited quantities currently. but when do you have when are you kind of at full run rate with respect to that presentation just curious if that just allows you to expand business with existing customers does it open new doors just because that's sort of the preferred offering in the market just strategically what does that mean in terms of growing the franchise going forward you know it's first of all it's

40:39 Thank you very much. So when a hospital pharmacist or when a home care pharmacist is preparing the immune globulin for infusion, typically you will either pull it into a type of infusion transfer bag or you're gonna hang each individual vial. Would you rather hang three vials or pull three vials or would you rather pull seven vials? I mean, it's a factor of labor costs. And when you're looking at our customer, and our customer really are the home care companies and the hospitals that are the place where patients are infusing the products.

41:49 They look at this like they're a manufacturing organization also and their time is worth money and they look at these things. Having the 100 ml vial certainly helps us to be more competitive especially in the higher volume, higher throughput specialty pharmacies, home care organizations and hospitals where Time is extremely valuable. I think that it also demonstrates our commitment to improving product quality and the diversity of our available offerings. These are all things that a commercial manufacturing business does. I think when you factor all this together, we don't have plans in the short term for additional vial sizes.

42:38 We plan to offer for Bibigam both the 5 and 10, 50 ml and 100 ml vial. The 100 ml vial is available now. So those are available for sale. And as Brian mentioned, the vials that we currently have were produced in those four conformance batches that were the basis for the prior approval supplement submission for the approval from FDA. So Elliot, you know, coming from a place where we You took over this plant with a warning letter. It was not in commercial production at that point in time. To fast forward, our four-year anniversary, if you will, was in the second quarter. June 6th was our fourth anniversary. And to get to a place where we've got a fill-finish line that we just completed an FDA pre-approval inspection with 043 observations, We've got new container closure system out there.

43:40 That means new vial, label, packaging, stopper cap. Multiple vial sizes across our product portfolio. Three products approved. The plasma center expansion and build out is exceeding our expectations. We've accomplished a lot of things in four years. I think that our customers see it. I know it's a long answer to your question about the 100 ml size, but I think it all really makes a difference and it puts ADMA on the same playing field as the CSLs, Takedas, Griffles, BPLs, and Kedrions. I don't think that there is a hospital pharmacy or a home care company out there that isn't aware that ADMA Biologics is a player and has grams available should they need them with Bivigam, Ascentive, and not BHB.

44:39 Thank you, Adam. And thank you. And with that, ladies and gentlemen, we are currently out of time. I'd like to turn the call back to Adam for additional closing remarks.

44:53 Thanks, everybody. I hope you found the call interesting. Again, to the ADMA team that's listening, truly proud of you. You guys are doing a great job. Let's keep helping the patients that are counting on us to our shareholders again. We appreciate your continued support and your investment in this business allows us to do the great work and help our fellow citizens. Thanks again. Thanks for dialing into the call. Donate plasma. Help save lives. We wish you all a healthy and safe evening. Take care. Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation and you may disconnect.