NASDAQ:ADMA ADMA Biologics Q2 2024 Earnings Report $22.33 +0.60 (+2.76%) As of 04/24/2025 04:00 PM Eastern Earnings HistoryForecast ADMA Biologics EPS ResultsActual EPS$0.13Consensus EPS $0.08Beat/MissBeat by +$0.05One Year Ago EPS-$0.02ADMA Biologics Revenue ResultsActual Revenue$107.20 millionExpected Revenue$86.44 millionBeat/MissBeat by +$20.76 millionYoY Revenue Growth+78.40%ADMA Biologics Announcement DetailsQuarterQ2 2024Date8/8/2024TimeAfter Market ClosesConference Call DateThursday, August 8, 2024Conference Call Time4:30PM ETUpcoming EarningsADMA Biologics' Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled on Friday, May 9, 2025 at 4:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by ADMA Biologics Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 8, 2024 ShareLink copied to clipboard.There are 7 speakers on the call. Operator00:00:00Good afternoon, and welcome to the ADMA Biologics' 2nd Quarter 2024 Financial Results and Business Update Conference Call on Thursday, August 8, 2024. 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 2 hours following the end of the call. At this time, I would like to introduce Skyler Bloom. Operator00:00:37Please go ahead. Speaker 100:00:43Welcome everyone and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the Q2 of 2024 and recent corporate updates. I am joined today by Adam Grossman, President and Chief Executive Officer and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress and then Brad provide an overview of the company's Q2 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the Q2 2024 financial results and summarize certain achievements and recent corporate updates. Speaker 100:01:27The 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 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 SEC filings, 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. Speaker 100:02:30We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section of our quarterly report on Form 10 Q for the quarter ended June 30, 2024 for a discussion of important factors that could cause actual results to differ materially from these forward looking statements. Please note that the discussion on today's call includes certain non GAAP financial measures, including adjusted EBITDA. A reconciliation of these non GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead. Speaker 200:03:08Thank you, Skyler, and welcome everybody to today's call. It has been quite a journey to eclipse $100,000,000 in revenue during a single calendar quarter. We are extremely proud to have achieved this milestone while managing expenses such that our earnings growth to date positions ADMA among the fastest growing and profitable companies in the biotech sector. It is truly remarkable and I salute and applaud the entire ADMA team. Our unwavering commitment to commercial, financial and operational excellence has once again yielded strong results during the Q2, exceeding analyst forecasts. Speaker 200:03:46Total revenues for the quarter grew by 78% year over year, reaching $107,200,000 This impressive revenue growth coupled with a tightly managed cost structure resulted in adjusted EBITDA of $44,500,000 representing a nearly 600% growth rate year over year. GAAP net income grew to $32,100,000 during the 2nd quarter compared to a GAAP net loss of $6,400,000 in the same period last year. While Brad will delve into the details, this quarter benefited from a one time accrual reversal, which increased both reported revenue and earnings. Although this favorable impact is non recurring in nature, the strength of our underlying business gives us confidence that we will be able to grow both the top and bottom lines from this new significantly increased financial baseline. We are again revising our financial guidance upwards for both 2024 2025. Speaker 200:04:52Based on current market conditions, we now anticipate generating total revenue of more than $400,000,000 for 20.24 $445,000,000 for 2025. At these revenue levels, we estimate adjusted EBITDA will exceed $150,000,000 $200,000,000 for 2024 and 2025 respectively, representing a 33% year over year growth rate. Similarly, we are increasing net income guidance to more than $105,000,000 for 20.24 $155,000,000 for 2025, reflecting an estimated 48% year over year growth rate. Our confidence in achieving these financial targets is underpinned by the rapid and continuous growth of our unique and proprietary immunoglobulin Affenitz. All forward looking demand KPIs for the product are reaching new highs. Speaker 200:05:49And encouragingly, both the breadth and depth of Acentiv's prescriber base continues to strengthen. As a result, I am pleased to report that Ascentiv has now surpassed a 50% contribution to ADNUS total revenue, marking a significant milestone for our company and setting the stage for further anticipated favorable mix shifts. To meet the growing demand for Ascentive, we are implementing measures to increase the availability of high titer raw material plasma and we are continuing to shift production capacity towards Ascentive. We are making progress with these initiatives And when completed, we believe Asceniv has the potential to contribute a significant majority to our total product revenue mix in due course. To better understand Ascentive's unique position and growth potential within the $12,000,000,000 and growing U. Speaker 200:06:45S. Immunoglobulin market, It is critical to consider our core focus on the 20000 to 30000 risk stratified refractive immunodeficient patients who have exhausted multiple lines of therapy throughout their treatment journey. These patients suffer from complex comorbidities, have often failed multiple standard immunoglobulin therapies and require additional concomitant medications. The unfortunate reality is these patients are regularly unable to conduct daily activities, including attending school or maintaining steady employment due to their complex health conditions, doctor's office visits and hospitalizations. Ascenet's unique and proprietary composition has proven to be well suited to address the challenging real world use cases. Speaker 200:07:37To further illustrate, during the Q2, we released a new patient video testimonial on the eSENIV product website, highlighting the remarkable treatment journey of a 17 year old immunocompromised patient on IVIG therapy. His inspiring story of resilience has resonated deeply in both the clinical and commercial settings. The founding principles of ADMO were built precisely with patients like this in mind and it is these success stories that continue to fuel our organization to improve the lives of immune compromised patients. While we are proud of the growing number of patients treated with ASCENTIVE to date, there is still much work to be done and there are many patients we have yet to reach. We estimate that Ascenet's current penetration within its core target market is less than 3% of the total addressable population, which has been largely governed by our ability to meet the outsized product demand. Speaker 200:08:36We are confident that the incremental additional penetration with Ascendiv will accelerate near term revenue and create substantial peak revenue opportunity beyond our 2025 guided base line. In that context, I would like to say that all of us at ADMA are extremely focused and will work tirelessly to produce more Ascentiv to meet the outsized demand. Ascentiv is proving to be a unique and potentially life changing treatment option for PI patients who had limited alternatives before its launch. Given this context, our efforts to potentially enhance immunoglobulin production yields through innovations in our manufacturing processes have continued to advance in 2024. Recent commercial scale production of our new processes demonstrated potential yield enhancement of approximately 20% more bulk drug from the same starting plasma. Speaker 200:09:32These initiatives are subject to further regulatory evaluation and review. And if approved, we anticipate realizing potentially transformative benefits beginning as early as late next year with revenue and earnings accretion then expected to accelerate over the course of the decade. As appropriate, we will formally guide to the magnitude and timing of these benefits as regulatory and operational developments progress. On the plasma supply front, our collection centers continue to perform well, which we believe positions us to meet increased production forecast for our IG portfolio. Hyperimmune plasma collections are increasing to support the growing demand and collection volumes across our network are reaching new highs. Speaker 200:10:19We believe we are well positioned for continued growth and innovation with a strong foundation for future success. Moving to Admelytics, our innovative AI and machine learning platform. We successfully expanded implementation of the technology to our commercial operations during the Q2. When fully implemented, we expect the rollout to further optimize our commercial growth strategy. Initiated in February of 2024, the staggered implementation of Admelytics has already yielded impressive results, including increased production efficiency, enhanced visibility into the manufacturing process, optimized commercial planning, streamlined plasma cooling and reduce variability in FTE hours. Speaker 200:11:06These efficiencies are expected to solidify our rapidly growing earnings outlook. Our portfolio of life changing medicines provides significant benefits to patients addressing diseases with unmet needs. We are proud of the difference we make for patients, donors and public health. Our accomplishments showcase the steadfast commitment and hard work of our exceptional team. To our employees, we extend our heartfelt gratitude for your dedication, which drives our progress and significantly helps those we serve. Speaker 200:11:41It is this collaborative spirit that makes our workplace unique. And with that said, I'd now like to turn the call over to Brad for a review of the Q2 2024 financials. Speaker 300:11:54Thank you, Adam. We issued a press release earlier today outlining our Q2 2024 financial results. And we will also be issuing our Q2 10 Q report later this afternoon, which we would encourage you to read in conjunction with the comments and discussion points we will make during today's call. I'll now discuss some of the key financial highlights from the Q2. As Adam mentioned, total revenues were $107,200,000 for the quarter ended June 30, 2024, as compared to $60,100,000 for the quarter ended June 30, 2023, an increase of $47,100,000 or approximately 78%. Speaker 300:12:38In addition to the rapid growth of commercial product revenue during quarter, reported results were favorably impacted by an accrual reversal related to historical estimated U. S. Medicaid rebates for ADMA's immunoglobulin products. With the assistance of a review conducted with a third party consultant during the quarter, ADMA recognized a $12,600,000 increase to net revenues and a corresponding reduction in the accrual balance. By way of background, Certna's Admis legacy accrual methodologies were developed at the time of commercial launch in the second half of twenty nineteen for Ascentiv and Divigant, a time in ADMA's commercial evolution when there existed customary uncertainties inherent to initial commercial drug launches that lack any operating history. Speaker 300:13:34Drawing from the last 2 years of significant commercial growth and product utilization for Ascentiv and BIVVIGAM, we are confident that our newly implemented methodologies are appropriate on a go forward basis. To reiterate Adam's earlier remarks, while this accrual reversal is non recurring in nature, the strength of our underlying business trends are such that we are confident in our ability to build on this newly established financial baseline and grow both revenue and earnings in the periods ahead. GAAP gross profits were $57,500,000 for the quarter ended June 30, 2024, as compared to $16,700,000 for the quarter ended June 30, 2023, an increase of $40,800,000 or an approximate 2 44 percent growth rate. As a result, ADMA achieved a corporate gross margin of 53.6% in the Q2 of 2024 as compared to 27.8% in the Q2 of 2023. As we progress further into 2024, we believe we are just beginning to generate financial results that demonstrate the distinct operating leverage that our business is capable of realizing. Speaker 300:14:56As our revenue continues to grow and fixed expenses are tightly managed. During the Q2, adjusted EBITDA was $44,500,000 as compared to adjusted EBITDA of $6,400,000 for the quarter ended June 30, 2023, an increase of $38,100,000 or nearly 600%. Additionally, GAAP net income was $32,100,000 for the quarter ended June 30, 2024 compared to a GAAP net loss of $6,400,000 for the quarter ended June 30, 2023. Based on the robust $43,400,000 of free cash flow generated in the Q2 and the significant adjusted EBITDA growth, the company's current net leverage ratio has organically improved to approximately 0.26 annualizing 2nd quarter results. We anticipate the balance sheet will continue to strengthen over the coming periods, augmented by forecasted free cash flow and growing adjusted EBITDA. Speaker 300:16:04With that, I'll now turn the call back over to Adam for closing remarks. Speaker 200:16:09Thank you, Brad. Our commitment to innovation and performance continues to drive significant growth and value creation, which we believe positions our company for enduring success. Over the remainder of 2024 and into 2025, we anticipate continued revenue growth and favorable mix shift leading in earnings profile that positions ADMA as one of the fastest growing and profitable biopharma companies in the United States. With net debt to adjusted EBITDA approaching 0, we believe we are embarking on the next phase of our growth cycle from a position of strength. We are committed to further fortifying our balance sheet, reducing the cost of capital and maximizing shareholder value. Speaker 200:16:52Looking beyond 2025, we plan on leveraging our innovative commercial model, specialty manufacturing and R and D platform to unlock a potential peak revenue and earnings opportunity reaching levels which may be multifold higher than our currently provided financial guidance. We expect to formally provide longer term guidance as internal developments unfold. Thank you for your continued support and dedication. Together, we will continue to write the story of ADMA's unique success. With that, we'll now open up the call for questions. Speaker 200:17:26Operator? Operator00:17:31Thank you. At this time, we will conduct a question and answer session. Our first question comes from the line of Anthony Petrone with Mizuho Americas. Your line is now open. Speaker 200:18:16How are you doing today? Speaker 400:18:18Thank you. And congratulations, Adam, and to the rest of the Admiral Biologics team. Obviously, a very impressive performance. This is the first time I've seen in a press release plus 600% growth in adjusted EBITDA. So obviously a milestone quarter on the top and bottom line. Speaker 400:18:36Congratulations. Maybe to start, we're counting now 6 consecutive quarters here of a beaten raise, Adam, and we're at the midpoint of 2024 and the company has been good in updating the 2 year forward outlook for 2024 and 2025. If we back out the accrual of $12,000,000 in the quarter, that base top line rate is growing 58%. You're obviously levering the P and L to higher How sustainable is the mix shift to incentive? What do you How sustainable is the mix shift to Ascentiv? Speaker 400:19:20What do you think the sort of go forward growth profile of this company could be? And if you have any thoughts on a peak margin potential that would be helpful. And I'll have a follow-up. Speaker 200:19:33Thanks, Anthony. We really appreciate it. I mean, look, it's a lot of the same story that you've heard me talk about for the last 6 plus calendar quarters. We've got a great team here. The company is working very efficiently. Speaker 200:19:48And honestly, this is what happens. I really believe when you make a good product that helps people. So we're very proud of all the work that we're doing. You're asking me a question for forward guidance and that's your job. We feel good about the guidance that we've given. Speaker 200:20:04We feel like we taking the same approach to guidance that we've always taken. But what I'll say is something that I've said in the past. Our goal here and the goal has always been to make as much incentive as we possibly can. We're proud to be in a place where we can announce that Ascentiv has passed the 50% contribution for the mix of our therapy business unit products. And we think Ascendiant can continue to grow and drive our forward looking top line and bottom line growth throughout the rest of this decade and into the future. Speaker 200:20:45As we've said, we've got IP protection into the mid-twenty 30s and we believe that we're making a product that is truly differentiated and we've identified appropriate use. I have said in the past that look, we've got a roughly 500,000, 600,000 liter capacity plant here. You take the plasma math at 4 grams per liter, you can roughly produce 2,000,000 grams, 2,500,000 grams of IG in this plant. If all of it was a scented, you're looking at 1,000,000,000 dollars 2,000,000,000 maybe more than that in total peak revenues. Now again, I've said this before, I'm not guiding to that. Speaker 200:21:21I'm not saying that that is going to happen, but this is what we are here to do. One of my folks here said, this is why we started the company. This is why we've worked so hard and jumped through all the hoops and hurdles that have come our way, we really believe that we've got an opportunity to change outcomes for patients. We're working really hard to collect more plasma. That's been the governor of really the growth here. Speaker 200:21:55It's our ability to collect more plasma. And you see that we're growing quarter over quarter. We're collecting more plasma. Our centers are working more efficiently than ever before. Our 3rd party supply contracts have been performing very, very well. Speaker 200:22:08But the forward looking demand continues to outpace supply and quite frankly that's what's driving our optimism going forward. So we believe that we've got visibility into the most compelling growth story in the sector right now. I mean, obviously, it's at a different scale here. But as we look over the next several years into the back part of the decade, we see great, great outlook ahead, especially in light of the contribution from yield enhancement, which we announced today for the first time. So very proud of it all. Speaker 200:22:48Hopefully that answers your question. Speaker 400:22:50Absolutely. And just a quick follow-up on Eseniv. Maybe a little bit just on the patient experience. I think it would be helpful. In other words, it's a highly compromised patient. Speaker 400:23:04Maybe give us an idea like how often are these patients hospitalized Speaker 300:23:10when they're not on eSENEV? Speaker 400:23:10And to what extent do you see just an improvement in the time between exacerbations like how stabilized do these patients get once they're on a SENATE? Thanks again. Congratulations. Speaker 200:23:23Thank you, Anthony. So every immunocompromised patient is different. Everybody's treatment journey, everybody's path to getting on IG has been different. Everybody responds to IG and the environment differently. So it's really hard to give you a very succinct answer there. Speaker 200:23:40But the patients are immune compromised. They've got primary immune deficiency, again, 1 of 300, 400 different genetic diseases that affect your body's ability to produce antibody and IG replaces those antibodies through passive immunoprophylaxis. You're looking at every 3 to 4 weeks for the rest of their lives, they remain on IG. We're very proud of our patient testimonial videos and I spoke about it during the prepared remarks. I really think that the most recent patient testimonial clearly identifies who we're trying to help. Speaker 200:24:21We quantified it in the prepared remarks. There are about 200,000 to 30,000 of the overarching 200,000 to 300,000, 400,000 patients with TI in the United States. We're targeting this 20% to 30% and these are patients that really have failed multiple lines of therapy. They've received other immunoglobulins and have not done well. They've had their dose increased. Speaker 200:24:46We're penetrated roughly about 3%, a little less than 3% at this time. And we know where the patients are. We've got lists of patients and we know docs that want to put patients on therapy. We've identified the regions for growth. We really feel that we are in a great position to capitalize on the great real world outcomes that doctors and patients have experienced with this. Speaker 200:25:15And we're working very closely with the payers to ensure coverage. So it's all falling into place. Again, I've said this before, I know I sound like a broken record, but we feel it's the early days for us. We feel that we're really just beginning here and we're looking forward to the future. Operator00:25:47Our next question comes from the line of Kristin Kluszka with Cantor Fitzgerald. Your line is now open. Speaker 500:25:56Hi, everyone. This is Rick Miller on for Kristen. Thanks for taking our questions and congrats on the quarter. On the biologic production yield enhancement you mentioned, can you sort of put this into context as it relates to the specific product mix that you're working with? Does this dovetail well specifically with the incentive product or is there something that could boost yield across the pipeline? Speaker 500:26:18How are you thinking about this? Speaker 200:26:21Thanks, Rick, very much for the question. So, I've said this before, the plant doesn't care what we make. We make the same thing every day. It's the starting plasma that really is what differentiates the products. BIVVIGAN using normal source plasma, Ascentiv blended from normal source with the high titer plasma and NaVY HB is made from hyper immune hepatitis B plasma. Speaker 200:26:49Yield enhancement specifically is being targeted to eosinib and bibigan production. So both products we anticipate should the process be approved after regulatory review. We feel that both products would experience 20% more bulk drug from the same starting plasma. So historically, I've said roughly about 4 grams per liter. So is where our historical yields have been for both drugs. Speaker 200:27:20So you're looking at adding 20% to that. This is going to help us drive growth, we think near term. I mean, if the sun, the moon and the stars align, Rick, maybe we'll see some accretion late next year, but we feel very confident as we look towards 2026 and through the back half of the decade that again, should all the testing come back, should regulatory review and approval go well, this is going to allow us to maximize every leader of plasma that we collect. Especially for ASCENTI, we're very proud of this because look, it's less than 5% of donors have the antibody profile that we're looking for. So finding these donors, their plasma is valuable, all plasma is valuable. Speaker 200:28:08And the altruism of our donors donating this, we're really excited that we are on the forefront, if you will. Our process development team is really forward thinking. We're really proud of the work that they do here. And I think we're in the lead here from a fractionation perspective with bringing a yield enhanced or a yield improved process to commercialization. So hopefully that answers your question. Speaker 500:28:40Yes. And a follow-up if we may. You mentioned the regulatory side of it. Is there anything you can say about what a potential regulatory pathway could look like here with this yield enhancement process? Speaker 200:28:54Sure. My understanding is this is a typical PAS prior approval supplement. So we're running comparability protocols showing that demonstrating comparability that all these different steps and some things that we're modifying and improving with our process are comparable to what we have existing in our current FDA approved BLAs for both ASCENET and VIVIGAN. So we'll submit data, we'll complete conformance lot production, we'll submit the package to the agency and typically prior approval supplements typically are a 6 month review. So we will keep the market apprised of our status as we move forward. Speaker 200:29:38But again, we're really working very, very hard to get to a place where we could have an approval sometime late next year or early 2020 Speaker 500:29:496. That's great. That helps a lot and thanks again. Speaker 200:29:52Thank you. Send our regards to Kristen. Operator00:29:58Thank you so much. One moment for our next question please. Our next question comes from the line of Gary Nachman with Raymond James. Your line is now open. Speaker 600:30:14Hi, guys. And my congrats as well on a really, really great quarter. Very impressive. Speaker 300:30:20Thank you, Gary. Speaker 600:30:22Yes. So back to the yield enhancements, I mean, given your history of conservatism, should we be thinking about 20% increase now as the max? Or could it be even higher than that over time with all your initiatives and the analytics program that you talked about? And then just on the operating leverage, it's really incredible what you're able to do keeping the expenses in check. But with the penetration of the Senate still less than 3%, it begs the question if it makes sense to invest more or do you have to first wait to have enough supply before you would spend more in sales and marketing, if that's a consideration? Speaker 200:31:07All great questions. Thank you for them. I wrote most of them down, but I do want to start off by saying, Gary, that Skyler reminded me that when you were on your first call with us, I said, welcome to the party. So I hope you're having a good time. But with regard to yield enhancement and conservatism, okay. Speaker 200:31:25So do not think about conservatism with this. This is scientific data. This is actual process data. So the approach that I take and that my team takes and that our advisors and counsel and Board takes to financial guidance, you shouldn't apply that here. This is pretty much what you're going to get. Speaker 200:31:49Is there some room for upside? I mean, Adam Grossman demands things, sure. I think my team is very good at what they do. I think that there may be some room, but it's 20%, it's 20% on both drug. And I think that as analysts and investors are looking at their models, I think that that is a very, very fair and appropriate target. Speaker 200:32:14So although I have this, I guess, stigma of being highly conservative with financial guidance, that should stay for financial guidance, 20% is 20%. Fair guys? Fair fair. It's not about sales and marketing spend, Gary. It's really there are 300, 400 doctors that are seeing the primary immune deficient population in the U. Speaker 200:32:41S. We know who the doctors are. We're involved and engaged deeply with the large private practices as well as the ambulatory and outpatient infusion centers, specialty pharmacies, PBMs that are dealing with the primary immune deficient patients on IG. We really feel very good about our geographic distribution and our ability to carry the message and to continue the medical education that we've been so successful with. We use capital efficient measures to grow our customer base as well as to grow the incentive supply availability. Speaker 200:33:29So we are working very, very hard within our own collection center network to incentivize RSV high tighter donors to come more frequently. We're working with our 3rd party suppliers to collect more and you couple that with yield enhancement. We're feeling that we are spending appropriately to try to catch up to be able to run side by side with the current demand for the product. So hopefully that answers your question. Yes. Speaker 200:34:04Just to further that point, right. I mean, we have been leveraging our org structure and we have said it a few times that we feel that we're structured in a way that we can grow. Are we going to have to augment certain areas of our structure? Absolutely. And we will continue to do that and we have done that. Speaker 200:34:21But again, that's kind of the beauty of this is we are structured for growth. We'll have to do some augmenting here and there, but we're structured for growth and the more the top line grows, the more it's going to fall through. So we feel like we're in a good place. Yes. I'll just say, Gary, that we work hard here. Speaker 200:34:38I mean we run lean, we always have since the beginning. And to my staff listening, I know that you've got lots of places to work, but it's a lot more fun here and it's very rewarding. But we're going to continue to run through walls for our shareholders. We're going to continue to run through walls for our patients. We love what we do, Gary. Speaker 200:35:00We make a good product that helps people. It's the best motivation, the best team builder. We feel really good about it. Everybody does here. So we're going to be successful working as a team. Speaker 600:35:13That's great. That was very helpful. And then just a couple more. Do you think physicians are considering using Ascentive as first line at all for PI patients that have comorbid respiratory conditions, whereas all the use still second line plus. And when you say Ascentiv can contribute significant majority over time, I know you chose those words carefully, but is that 2 thirds, 75% more than that? Speaker 600:35:39What's a reasonable expectation there? Speaker 200:35:41I hope it's 100%, Gary. That's what I hope. I have no idea. I mean, my crystal ball didn't tell me all these things that are happening today. So I'm just going to say that we're going after the complex comorbid PI patient. Speaker 200:36:04Adam Grossman does not believe that in PI you should use a SENIV as a first line therapy. I just don't I just think that appropriate use are for patients like I described. If you haven't seen on the ASCENTI product website, we want appropriate use. The right thing for the immune compromised patient population is appropriate use. Not every patient needs to be on a sense. Speaker 200:36:33And I'm sure there aren't a lot of CEOs are going to say things like that, but not every patient needs to be on Ascenet. Some patients do very, very well on standard regular IGs. I mean, we've got patients on vivigame, it's a great drug. It's a great drug. It's made the same way as a Seniv. Speaker 200:36:50It's got the same impurity profile as a Seniv. It's really a good wonderful product. Some patients thrive on it and we're very excited. But with respect to Eseniv and the refractive comorbid, more severely immune compromised population, payers recognize the fact that we are defining appropriate use well. The pharmacoeconomic value proposition is resonating in this population. Speaker 200:37:23And I think that that's where we're going to be successful. There are plenty of patients out there. The IG market is robust and growing. Our brethren companies in this space are all reporting increased utilization. We're very proud that we make our products the way we do and that we got a truly differentiated and unique product with Ascenix. Speaker 200:37:48So we're offering an alternative for doctors and patients who have tried everything that they can, increased dose, switched brands, subcu IV. If those fail, come to a Senate. It makes it a little bit easier to work with the payer when you've got a patient who's using this product as a second, 3rd or 4th line therapy. Speaker 600:38:15Okay, great. And congrats again really. I'm very impressive. Thanks. Speaker 200:38:21Thank you, Gary. Told you I wouldn't let you down. Speaker 600:38:26Thank you. Operator00:38:30All right. Thank you so much. This concludes the question and answer session. I would now like to turn it back to Adam Grossman for closing remarks. Speaker 200:38:45I just want to thank the ADMA team. None of this is possible without all of you. You're doing great work. You're impacting, changing, improving lives. Let's keep it up to everyone else out there, to all of our stockholders, investors and other constituents. Speaker 200:39:05We hope you're pleased. We're going to continue to do what we do, make good products that help people. So thank you for your continued support and we'll see you next quarter. Operator00:39:18Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallADMA Biologics Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) ADMA Biologics Earnings HeadlinesADMA Biologics, Inc. (ADMA): Among Takeover Rumors Hedge Funds Are BuyingApril 23 at 10:25 PM | insidermonkey.comIs ADMA Biologics, Inc. 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Sign up for Earnings360's daily newsletter to receive timely earnings updates on ADMA Biologics and other key companies, straight to your email. Email Address About ADMA BiologicsADMA Biologics (NASDAQ:ADMA), a biopharmaceutical company, engages in developing, manufacturing, and marketing specialty plasma-derived biologics for the treatment of immune deficiencies and infectious diseases in the United States and internationally. The company offers BIVIGAM, an intravenous immune globulin (IVIG) product indicated for the treatment of primary humoral immunodeficiency (PI); ASCENIV, an IVIG product for the treatment of PI; and Nabi-HB for the treatment of acute exposure to blood containing Hepatitis B surface antigen and other listed exposures to Hepatitis B. It develops a pipeline of plasma-derived therapeutics, including products related to the methods of treatment and prevention of S. pneumonia infection for an immunoglobulin. In addition, it operates source plasma collection facilities. The company sells its products through independent distributors, drug wholesalers, specialty pharmacies, and other alternate site providers. ADMA Biologics, Inc. was incorporated in 2004 and is headquartered in Ramsey, New Jersey.View ADMA Biologics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Tesla Earnings Miss, But Musk Refocuses and Bulls ReactQualcomm’s Range Narrows Ahead of Earnings as Bulls Step InWhy It May Be Time to Buy CrowdStrike Stock Heading Into EarningsCan IBM’s Q1 Earnings Spark a Breakout for the Stock? 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There are 7 speakers on the call. Operator00:00:00Good afternoon, and welcome to the ADMA Biologics' 2nd Quarter 2024 Financial Results and Business Update Conference Call on Thursday, August 8, 2024. 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 2 hours following the end of the call. At this time, I would like to introduce Skyler Bloom. Operator00:00:37Please go ahead. Speaker 100:00:43Welcome everyone and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the Q2 of 2024 and recent corporate updates. I am joined today by Adam Grossman, President and Chief Executive Officer and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress and then Brad provide an overview of the company's Q2 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the Q2 2024 financial results and summarize certain achievements and recent corporate updates. Speaker 100:01:27The 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 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 SEC filings, 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. Speaker 100:02:30We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section of our quarterly report on Form 10 Q for the quarter ended June 30, 2024 for a discussion of important factors that could cause actual results to differ materially from these forward looking statements. Please note that the discussion on today's call includes certain non GAAP financial measures, including adjusted EBITDA. A reconciliation of these non GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead. Speaker 200:03:08Thank you, Skyler, and welcome everybody to today's call. It has been quite a journey to eclipse $100,000,000 in revenue during a single calendar quarter. We are extremely proud to have achieved this milestone while managing expenses such that our earnings growth to date positions ADMA among the fastest growing and profitable companies in the biotech sector. It is truly remarkable and I salute and applaud the entire ADMA team. Our unwavering commitment to commercial, financial and operational excellence has once again yielded strong results during the Q2, exceeding analyst forecasts. Speaker 200:03:46Total revenues for the quarter grew by 78% year over year, reaching $107,200,000 This impressive revenue growth coupled with a tightly managed cost structure resulted in adjusted EBITDA of $44,500,000 representing a nearly 600% growth rate year over year. GAAP net income grew to $32,100,000 during the 2nd quarter compared to a GAAP net loss of $6,400,000 in the same period last year. While Brad will delve into the details, this quarter benefited from a one time accrual reversal, which increased both reported revenue and earnings. Although this favorable impact is non recurring in nature, the strength of our underlying business gives us confidence that we will be able to grow both the top and bottom lines from this new significantly increased financial baseline. We are again revising our financial guidance upwards for both 2024 2025. Speaker 200:04:52Based on current market conditions, we now anticipate generating total revenue of more than $400,000,000 for 20.24 $445,000,000 for 2025. At these revenue levels, we estimate adjusted EBITDA will exceed $150,000,000 $200,000,000 for 2024 and 2025 respectively, representing a 33% year over year growth rate. Similarly, we are increasing net income guidance to more than $105,000,000 for 20.24 $155,000,000 for 2025, reflecting an estimated 48% year over year growth rate. Our confidence in achieving these financial targets is underpinned by the rapid and continuous growth of our unique and proprietary immunoglobulin Affenitz. All forward looking demand KPIs for the product are reaching new highs. Speaker 200:05:49And encouragingly, both the breadth and depth of Acentiv's prescriber base continues to strengthen. As a result, I am pleased to report that Ascentiv has now surpassed a 50% contribution to ADNUS total revenue, marking a significant milestone for our company and setting the stage for further anticipated favorable mix shifts. To meet the growing demand for Ascentive, we are implementing measures to increase the availability of high titer raw material plasma and we are continuing to shift production capacity towards Ascentive. We are making progress with these initiatives And when completed, we believe Asceniv has the potential to contribute a significant majority to our total product revenue mix in due course. To better understand Ascentive's unique position and growth potential within the $12,000,000,000 and growing U. Speaker 200:06:45S. Immunoglobulin market, It is critical to consider our core focus on the 20000 to 30000 risk stratified refractive immunodeficient patients who have exhausted multiple lines of therapy throughout their treatment journey. These patients suffer from complex comorbidities, have often failed multiple standard immunoglobulin therapies and require additional concomitant medications. The unfortunate reality is these patients are regularly unable to conduct daily activities, including attending school or maintaining steady employment due to their complex health conditions, doctor's office visits and hospitalizations. Ascenet's unique and proprietary composition has proven to be well suited to address the challenging real world use cases. Speaker 200:07:37To further illustrate, during the Q2, we released a new patient video testimonial on the eSENIV product website, highlighting the remarkable treatment journey of a 17 year old immunocompromised patient on IVIG therapy. His inspiring story of resilience has resonated deeply in both the clinical and commercial settings. The founding principles of ADMO were built precisely with patients like this in mind and it is these success stories that continue to fuel our organization to improve the lives of immune compromised patients. While we are proud of the growing number of patients treated with ASCENTIVE to date, there is still much work to be done and there are many patients we have yet to reach. We estimate that Ascenet's current penetration within its core target market is less than 3% of the total addressable population, which has been largely governed by our ability to meet the outsized product demand. Speaker 200:08:36We are confident that the incremental additional penetration with Ascendiv will accelerate near term revenue and create substantial peak revenue opportunity beyond our 2025 guided base line. In that context, I would like to say that all of us at ADMA are extremely focused and will work tirelessly to produce more Ascentiv to meet the outsized demand. Ascentiv is proving to be a unique and potentially life changing treatment option for PI patients who had limited alternatives before its launch. Given this context, our efforts to potentially enhance immunoglobulin production yields through innovations in our manufacturing processes have continued to advance in 2024. Recent commercial scale production of our new processes demonstrated potential yield enhancement of approximately 20% more bulk drug from the same starting plasma. Speaker 200:09:32These initiatives are subject to further regulatory evaluation and review. And if approved, we anticipate realizing potentially transformative benefits beginning as early as late next year with revenue and earnings accretion then expected to accelerate over the course of the decade. As appropriate, we will formally guide to the magnitude and timing of these benefits as regulatory and operational developments progress. On the plasma supply front, our collection centers continue to perform well, which we believe positions us to meet increased production forecast for our IG portfolio. Hyperimmune plasma collections are increasing to support the growing demand and collection volumes across our network are reaching new highs. Speaker 200:10:19We believe we are well positioned for continued growth and innovation with a strong foundation for future success. Moving to Admelytics, our innovative AI and machine learning platform. We successfully expanded implementation of the technology to our commercial operations during the Q2. When fully implemented, we expect the rollout to further optimize our commercial growth strategy. Initiated in February of 2024, the staggered implementation of Admelytics has already yielded impressive results, including increased production efficiency, enhanced visibility into the manufacturing process, optimized commercial planning, streamlined plasma cooling and reduce variability in FTE hours. Speaker 200:11:06These efficiencies are expected to solidify our rapidly growing earnings outlook. Our portfolio of life changing medicines provides significant benefits to patients addressing diseases with unmet needs. We are proud of the difference we make for patients, donors and public health. Our accomplishments showcase the steadfast commitment and hard work of our exceptional team. To our employees, we extend our heartfelt gratitude for your dedication, which drives our progress and significantly helps those we serve. Speaker 200:11:41It is this collaborative spirit that makes our workplace unique. And with that said, I'd now like to turn the call over to Brad for a review of the Q2 2024 financials. Speaker 300:11:54Thank you, Adam. We issued a press release earlier today outlining our Q2 2024 financial results. And we will also be issuing our Q2 10 Q report later this afternoon, which we would encourage you to read in conjunction with the comments and discussion points we will make during today's call. I'll now discuss some of the key financial highlights from the Q2. As Adam mentioned, total revenues were $107,200,000 for the quarter ended June 30, 2024, as compared to $60,100,000 for the quarter ended June 30, 2023, an increase of $47,100,000 or approximately 78%. Speaker 300:12:38In addition to the rapid growth of commercial product revenue during quarter, reported results were favorably impacted by an accrual reversal related to historical estimated U. S. Medicaid rebates for ADMA's immunoglobulin products. With the assistance of a review conducted with a third party consultant during the quarter, ADMA recognized a $12,600,000 increase to net revenues and a corresponding reduction in the accrual balance. By way of background, Certna's Admis legacy accrual methodologies were developed at the time of commercial launch in the second half of twenty nineteen for Ascentiv and Divigant, a time in ADMA's commercial evolution when there existed customary uncertainties inherent to initial commercial drug launches that lack any operating history. Speaker 300:13:34Drawing from the last 2 years of significant commercial growth and product utilization for Ascentiv and BIVVIGAM, we are confident that our newly implemented methodologies are appropriate on a go forward basis. To reiterate Adam's earlier remarks, while this accrual reversal is non recurring in nature, the strength of our underlying business trends are such that we are confident in our ability to build on this newly established financial baseline and grow both revenue and earnings in the periods ahead. GAAP gross profits were $57,500,000 for the quarter ended June 30, 2024, as compared to $16,700,000 for the quarter ended June 30, 2023, an increase of $40,800,000 or an approximate 2 44 percent growth rate. As a result, ADMA achieved a corporate gross margin of 53.6% in the Q2 of 2024 as compared to 27.8% in the Q2 of 2023. As we progress further into 2024, we believe we are just beginning to generate financial results that demonstrate the distinct operating leverage that our business is capable of realizing. Speaker 300:14:56As our revenue continues to grow and fixed expenses are tightly managed. During the Q2, adjusted EBITDA was $44,500,000 as compared to adjusted EBITDA of $6,400,000 for the quarter ended June 30, 2023, an increase of $38,100,000 or nearly 600%. Additionally, GAAP net income was $32,100,000 for the quarter ended June 30, 2024 compared to a GAAP net loss of $6,400,000 for the quarter ended June 30, 2023. Based on the robust $43,400,000 of free cash flow generated in the Q2 and the significant adjusted EBITDA growth, the company's current net leverage ratio has organically improved to approximately 0.26 annualizing 2nd quarter results. We anticipate the balance sheet will continue to strengthen over the coming periods, augmented by forecasted free cash flow and growing adjusted EBITDA. Speaker 300:16:04With that, I'll now turn the call back over to Adam for closing remarks. Speaker 200:16:09Thank you, Brad. Our commitment to innovation and performance continues to drive significant growth and value creation, which we believe positions our company for enduring success. Over the remainder of 2024 and into 2025, we anticipate continued revenue growth and favorable mix shift leading in earnings profile that positions ADMA as one of the fastest growing and profitable biopharma companies in the United States. With net debt to adjusted EBITDA approaching 0, we believe we are embarking on the next phase of our growth cycle from a position of strength. We are committed to further fortifying our balance sheet, reducing the cost of capital and maximizing shareholder value. Speaker 200:16:52Looking beyond 2025, we plan on leveraging our innovative commercial model, specialty manufacturing and R and D platform to unlock a potential peak revenue and earnings opportunity reaching levels which may be multifold higher than our currently provided financial guidance. We expect to formally provide longer term guidance as internal developments unfold. Thank you for your continued support and dedication. Together, we will continue to write the story of ADMA's unique success. With that, we'll now open up the call for questions. Speaker 200:17:26Operator? Operator00:17:31Thank you. At this time, we will conduct a question and answer session. Our first question comes from the line of Anthony Petrone with Mizuho Americas. Your line is now open. Speaker 200:18:16How are you doing today? Speaker 400:18:18Thank you. And congratulations, Adam, and to the rest of the Admiral Biologics team. Obviously, a very impressive performance. This is the first time I've seen in a press release plus 600% growth in adjusted EBITDA. So obviously a milestone quarter on the top and bottom line. Speaker 400:18:36Congratulations. Maybe to start, we're counting now 6 consecutive quarters here of a beaten raise, Adam, and we're at the midpoint of 2024 and the company has been good in updating the 2 year forward outlook for 2024 and 2025. If we back out the accrual of $12,000,000 in the quarter, that base top line rate is growing 58%. You're obviously levering the P and L to higher How sustainable is the mix shift to incentive? What do you How sustainable is the mix shift to Ascentiv? Speaker 400:19:20What do you think the sort of go forward growth profile of this company could be? And if you have any thoughts on a peak margin potential that would be helpful. And I'll have a follow-up. Speaker 200:19:33Thanks, Anthony. We really appreciate it. I mean, look, it's a lot of the same story that you've heard me talk about for the last 6 plus calendar quarters. We've got a great team here. The company is working very efficiently. Speaker 200:19:48And honestly, this is what happens. I really believe when you make a good product that helps people. So we're very proud of all the work that we're doing. You're asking me a question for forward guidance and that's your job. We feel good about the guidance that we've given. Speaker 200:20:04We feel like we taking the same approach to guidance that we've always taken. But what I'll say is something that I've said in the past. Our goal here and the goal has always been to make as much incentive as we possibly can. We're proud to be in a place where we can announce that Ascentiv has passed the 50% contribution for the mix of our therapy business unit products. And we think Ascendiant can continue to grow and drive our forward looking top line and bottom line growth throughout the rest of this decade and into the future. Speaker 200:20:45As we've said, we've got IP protection into the mid-twenty 30s and we believe that we're making a product that is truly differentiated and we've identified appropriate use. I have said in the past that look, we've got a roughly 500,000, 600,000 liter capacity plant here. You take the plasma math at 4 grams per liter, you can roughly produce 2,000,000 grams, 2,500,000 grams of IG in this plant. If all of it was a scented, you're looking at 1,000,000,000 dollars 2,000,000,000 maybe more than that in total peak revenues. Now again, I've said this before, I'm not guiding to that. Speaker 200:21:21I'm not saying that that is going to happen, but this is what we are here to do. One of my folks here said, this is why we started the company. This is why we've worked so hard and jumped through all the hoops and hurdles that have come our way, we really believe that we've got an opportunity to change outcomes for patients. We're working really hard to collect more plasma. That's been the governor of really the growth here. Speaker 200:21:55It's our ability to collect more plasma. And you see that we're growing quarter over quarter. We're collecting more plasma. Our centers are working more efficiently than ever before. Our 3rd party supply contracts have been performing very, very well. Speaker 200:22:08But the forward looking demand continues to outpace supply and quite frankly that's what's driving our optimism going forward. So we believe that we've got visibility into the most compelling growth story in the sector right now. I mean, obviously, it's at a different scale here. But as we look over the next several years into the back part of the decade, we see great, great outlook ahead, especially in light of the contribution from yield enhancement, which we announced today for the first time. So very proud of it all. Speaker 200:22:48Hopefully that answers your question. Speaker 400:22:50Absolutely. And just a quick follow-up on Eseniv. Maybe a little bit just on the patient experience. I think it would be helpful. In other words, it's a highly compromised patient. Speaker 400:23:04Maybe give us an idea like how often are these patients hospitalized Speaker 300:23:10when they're not on eSENEV? Speaker 400:23:10And to what extent do you see just an improvement in the time between exacerbations like how stabilized do these patients get once they're on a SENATE? Thanks again. Congratulations. Speaker 200:23:23Thank you, Anthony. So every immunocompromised patient is different. Everybody's treatment journey, everybody's path to getting on IG has been different. Everybody responds to IG and the environment differently. So it's really hard to give you a very succinct answer there. Speaker 200:23:40But the patients are immune compromised. They've got primary immune deficiency, again, 1 of 300, 400 different genetic diseases that affect your body's ability to produce antibody and IG replaces those antibodies through passive immunoprophylaxis. You're looking at every 3 to 4 weeks for the rest of their lives, they remain on IG. We're very proud of our patient testimonial videos and I spoke about it during the prepared remarks. I really think that the most recent patient testimonial clearly identifies who we're trying to help. Speaker 200:24:21We quantified it in the prepared remarks. There are about 200,000 to 30,000 of the overarching 200,000 to 300,000, 400,000 patients with TI in the United States. We're targeting this 20% to 30% and these are patients that really have failed multiple lines of therapy. They've received other immunoglobulins and have not done well. They've had their dose increased. Speaker 200:24:46We're penetrated roughly about 3%, a little less than 3% at this time. And we know where the patients are. We've got lists of patients and we know docs that want to put patients on therapy. We've identified the regions for growth. We really feel that we are in a great position to capitalize on the great real world outcomes that doctors and patients have experienced with this. Speaker 200:25:15And we're working very closely with the payers to ensure coverage. So it's all falling into place. Again, I've said this before, I know I sound like a broken record, but we feel it's the early days for us. We feel that we're really just beginning here and we're looking forward to the future. Operator00:25:47Our next question comes from the line of Kristin Kluszka with Cantor Fitzgerald. Your line is now open. Speaker 500:25:56Hi, everyone. This is Rick Miller on for Kristen. Thanks for taking our questions and congrats on the quarter. On the biologic production yield enhancement you mentioned, can you sort of put this into context as it relates to the specific product mix that you're working with? Does this dovetail well specifically with the incentive product or is there something that could boost yield across the pipeline? Speaker 500:26:18How are you thinking about this? Speaker 200:26:21Thanks, Rick, very much for the question. So, I've said this before, the plant doesn't care what we make. We make the same thing every day. It's the starting plasma that really is what differentiates the products. BIVVIGAN using normal source plasma, Ascentiv blended from normal source with the high titer plasma and NaVY HB is made from hyper immune hepatitis B plasma. Speaker 200:26:49Yield enhancement specifically is being targeted to eosinib and bibigan production. So both products we anticipate should the process be approved after regulatory review. We feel that both products would experience 20% more bulk drug from the same starting plasma. So historically, I've said roughly about 4 grams per liter. So is where our historical yields have been for both drugs. Speaker 200:27:20So you're looking at adding 20% to that. This is going to help us drive growth, we think near term. I mean, if the sun, the moon and the stars align, Rick, maybe we'll see some accretion late next year, but we feel very confident as we look towards 2026 and through the back half of the decade that again, should all the testing come back, should regulatory review and approval go well, this is going to allow us to maximize every leader of plasma that we collect. Especially for ASCENTI, we're very proud of this because look, it's less than 5% of donors have the antibody profile that we're looking for. So finding these donors, their plasma is valuable, all plasma is valuable. Speaker 200:28:08And the altruism of our donors donating this, we're really excited that we are on the forefront, if you will. Our process development team is really forward thinking. We're really proud of the work that they do here. And I think we're in the lead here from a fractionation perspective with bringing a yield enhanced or a yield improved process to commercialization. So hopefully that answers your question. Speaker 500:28:40Yes. And a follow-up if we may. You mentioned the regulatory side of it. Is there anything you can say about what a potential regulatory pathway could look like here with this yield enhancement process? Speaker 200:28:54Sure. My understanding is this is a typical PAS prior approval supplement. So we're running comparability protocols showing that demonstrating comparability that all these different steps and some things that we're modifying and improving with our process are comparable to what we have existing in our current FDA approved BLAs for both ASCENET and VIVIGAN. So we'll submit data, we'll complete conformance lot production, we'll submit the package to the agency and typically prior approval supplements typically are a 6 month review. So we will keep the market apprised of our status as we move forward. Speaker 200:29:38But again, we're really working very, very hard to get to a place where we could have an approval sometime late next year or early 2020 Speaker 500:29:496. That's great. That helps a lot and thanks again. Speaker 200:29:52Thank you. Send our regards to Kristen. Operator00:29:58Thank you so much. One moment for our next question please. Our next question comes from the line of Gary Nachman with Raymond James. Your line is now open. Speaker 600:30:14Hi, guys. And my congrats as well on a really, really great quarter. Very impressive. Speaker 300:30:20Thank you, Gary. Speaker 600:30:22Yes. So back to the yield enhancements, I mean, given your history of conservatism, should we be thinking about 20% increase now as the max? Or could it be even higher than that over time with all your initiatives and the analytics program that you talked about? And then just on the operating leverage, it's really incredible what you're able to do keeping the expenses in check. But with the penetration of the Senate still less than 3%, it begs the question if it makes sense to invest more or do you have to first wait to have enough supply before you would spend more in sales and marketing, if that's a consideration? Speaker 200:31:07All great questions. Thank you for them. I wrote most of them down, but I do want to start off by saying, Gary, that Skyler reminded me that when you were on your first call with us, I said, welcome to the party. So I hope you're having a good time. But with regard to yield enhancement and conservatism, okay. Speaker 200:31:25So do not think about conservatism with this. This is scientific data. This is actual process data. So the approach that I take and that my team takes and that our advisors and counsel and Board takes to financial guidance, you shouldn't apply that here. This is pretty much what you're going to get. Speaker 200:31:49Is there some room for upside? I mean, Adam Grossman demands things, sure. I think my team is very good at what they do. I think that there may be some room, but it's 20%, it's 20% on both drug. And I think that as analysts and investors are looking at their models, I think that that is a very, very fair and appropriate target. Speaker 200:32:14So although I have this, I guess, stigma of being highly conservative with financial guidance, that should stay for financial guidance, 20% is 20%. Fair guys? Fair fair. It's not about sales and marketing spend, Gary. It's really there are 300, 400 doctors that are seeing the primary immune deficient population in the U. Speaker 200:32:41S. We know who the doctors are. We're involved and engaged deeply with the large private practices as well as the ambulatory and outpatient infusion centers, specialty pharmacies, PBMs that are dealing with the primary immune deficient patients on IG. We really feel very good about our geographic distribution and our ability to carry the message and to continue the medical education that we've been so successful with. We use capital efficient measures to grow our customer base as well as to grow the incentive supply availability. Speaker 200:33:29So we are working very, very hard within our own collection center network to incentivize RSV high tighter donors to come more frequently. We're working with our 3rd party suppliers to collect more and you couple that with yield enhancement. We're feeling that we are spending appropriately to try to catch up to be able to run side by side with the current demand for the product. So hopefully that answers your question. Yes. Speaker 200:34:04Just to further that point, right. I mean, we have been leveraging our org structure and we have said it a few times that we feel that we're structured in a way that we can grow. Are we going to have to augment certain areas of our structure? Absolutely. And we will continue to do that and we have done that. Speaker 200:34:21But again, that's kind of the beauty of this is we are structured for growth. We'll have to do some augmenting here and there, but we're structured for growth and the more the top line grows, the more it's going to fall through. So we feel like we're in a good place. Yes. I'll just say, Gary, that we work hard here. Speaker 200:34:38I mean we run lean, we always have since the beginning. And to my staff listening, I know that you've got lots of places to work, but it's a lot more fun here and it's very rewarding. But we're going to continue to run through walls for our shareholders. We're going to continue to run through walls for our patients. We love what we do, Gary. Speaker 200:35:00We make a good product that helps people. It's the best motivation, the best team builder. We feel really good about it. Everybody does here. So we're going to be successful working as a team. Speaker 600:35:13That's great. That was very helpful. And then just a couple more. Do you think physicians are considering using Ascentive as first line at all for PI patients that have comorbid respiratory conditions, whereas all the use still second line plus. And when you say Ascentiv can contribute significant majority over time, I know you chose those words carefully, but is that 2 thirds, 75% more than that? Speaker 600:35:39What's a reasonable expectation there? Speaker 200:35:41I hope it's 100%, Gary. That's what I hope. I have no idea. I mean, my crystal ball didn't tell me all these things that are happening today. So I'm just going to say that we're going after the complex comorbid PI patient. Speaker 200:36:04Adam Grossman does not believe that in PI you should use a SENIV as a first line therapy. I just don't I just think that appropriate use are for patients like I described. If you haven't seen on the ASCENTI product website, we want appropriate use. The right thing for the immune compromised patient population is appropriate use. Not every patient needs to be on a sense. Speaker 200:36:33And I'm sure there aren't a lot of CEOs are going to say things like that, but not every patient needs to be on Ascenet. Some patients do very, very well on standard regular IGs. I mean, we've got patients on vivigame, it's a great drug. It's a great drug. It's made the same way as a Seniv. Speaker 200:36:50It's got the same impurity profile as a Seniv. It's really a good wonderful product. Some patients thrive on it and we're very excited. But with respect to Eseniv and the refractive comorbid, more severely immune compromised population, payers recognize the fact that we are defining appropriate use well. The pharmacoeconomic value proposition is resonating in this population. Speaker 200:37:23And I think that that's where we're going to be successful. There are plenty of patients out there. The IG market is robust and growing. Our brethren companies in this space are all reporting increased utilization. We're very proud that we make our products the way we do and that we got a truly differentiated and unique product with Ascenix. Speaker 200:37:48So we're offering an alternative for doctors and patients who have tried everything that they can, increased dose, switched brands, subcu IV. If those fail, come to a Senate. It makes it a little bit easier to work with the payer when you've got a patient who's using this product as a second, 3rd or 4th line therapy. Speaker 600:38:15Okay, great. And congrats again really. I'm very impressive. Thanks. Speaker 200:38:21Thank you, Gary. Told you I wouldn't let you down. Speaker 600:38:26Thank you. Operator00:38:30All right. Thank you so much. This concludes the question and answer session. I would now like to turn it back to Adam Grossman for closing remarks. Speaker 200:38:45I just want to thank the ADMA team. None of this is possible without all of you. You're doing great work. You're impacting, changing, improving lives. Let's keep it up to everyone else out there, to all of our stockholders, investors and other constituents. Speaker 200:39:05We hope you're pleased. We're going to continue to do what we do, make good products that help people. So thank you for your continued support and we'll see you next quarter. Operator00:39:18Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by