ADMA - NASDAQ

Good afternoon, and welcome to the ADMA Biologics Second Quarter 2024 Financial Results and Business Update Conference Call on Thursday, August 08, 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. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the second quarter of 2024 and recent corporate updates. I’m joined today by Adam Grossman, President, 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 will provide an overview of the company’s second quarter 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 second quarter 2024 financial results and summarized certain achievements in recent corporate updates. The release is available on our website at www.admabiologics.com. Before we begin our formal comments, I’ll remind you that we will be making forward-looking assertions during today’s call that 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 obligation to update any such statements except as required by the federal securities laws. We refer you to the Disclosure Notice section in our earnings release we issued today in the Risk Factors section of our quarterly report on Form 10-Q for the year 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.

Thank you, Skyler, and welcome everybody to today's call. It has been quite a journey to eclipse $100 million 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 second quarter, exceeding analyst forecasts. Total revenues for the quarter grew by 78% year-over-year, reaching $107.2 million. This impressive revenue growth, coupled with a tightly managed cost structure resulted in adjusted EBITDA of $44.5 million, representing a nearly 600% growth rate year-over-year. GAAP net income grew to $32.1 million during the second quarter, compared to a GAAP net loss of $6.4 million 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 and 2025. Based on current market conditions, we now anticipate generating total revenue of more than $400 million for 2024 and $445 million for 2025. At these revenue levels, we estimate adjusted EBITDA will exceed $150 million and $200 million for 2024 and 2025, respectively, representing a 33% year-over-year growth rate. Similarly, we are increasing net income guidance to more than $105 million for 2024 and $155 million 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, ASCENIV. All forward-looking demand KPIs for the product are reaching new highs. And encouragingly, both the breadth and depth of ASCENIV's prescriber base continues to strengthen. As a result, I am pleased to report that ASCENIV has now surpassed a 50% contribution to ADMA's 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 ASCENIV, we are implementing measures to increase the availability of high titer raw material plasma, and we are continuing to shift production capacity towards ASCENIV. 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 ASCENIV's unique position and growth potential within the $12 billion and growing U.S. immunoglobulin market, it is critical to consider our core focus on the 20,000 to 30,000 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. ASCENIV's unique and proprietary composition has proven to be well-suited to address the challenging real-world use cases. To further illustrate, during the second quarter, we released a new patient video testimonial on the ASCENIV 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 ADMA 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 ASCENIV to date, there is still much work to be done, and there are many patients we have yet to reach. We estimate that ASCENIV'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. We are confident that the incremental additional penetration with ASCENIV will accelerate near-term revenue and create substantial peak revenue opportunity beyond our 2025 guided baseline. In that context, I would like to say that all of us at ADMA are extremely focused and will work tirelessly to produce more ASCENIV to meet the outsized demand. ASCENIV 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 or 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. These 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 forecasts for our IG portfolio. Hyperimmune plasma collections are increasing to support the growing demand, and collection volumes across our network are reaching new highs. We believe we are well-positioned for continued growth and innovation with a strong foundation for future success. Moving to ADMAlytics, our innovative AI machine learning platform. We successfully expanded implementation of the technology to our commercial operations during the second quarter. When fully implemented, we expect the rollout to further optimize our commercial growth strategy. Initiated in February of 2024, the staggered implementation of ADMAlytics has already yielded impressive results, including increased production efficiency, enhanced visibility into the manufacturing process, optimized commercial planning, streamlined plasma pooling, and reduced variability in FTE hours. These 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. It 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 second quarter 2024 financials.

Thank you, Adam. We issued a press release earlier today outlining our second quarter 2024 financial results. We will also be issuing our second quarter 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 second quarter. As Adam mentioned, total revenues were $107.2 million for the quarter ended June 30, 2024 as compared to $60.1 million for the quarter ended June 30, 2023, an increase of $47.1 million, or approximately 78%. In addition to the rapid growth of commercial product revenue during the second 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 $12.6 million increase to net revenues and a corresponding reduction in the accrual balance. By way of background, certain of ADMA's legacy accrual methodologies were developed at the time of commercial launch in the second half of 2019 for ASCENIV and BIVIGAM, a time in ADMA's commercial evolution when there existed customary uncertainties inherent to initial commercial drug launches that lack any operating history. Drawing from the last 2 years of significant commercial growth and product utilization for ASCENIV and BIVIGAM, 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 $57.5 million for the quarter ended June 30, 2024, as compared to $16.7 million for the quarter ended June 30, 2023, an increase of $40.8 million, or an approximate 244% growth rate. As a result, ADMA achieved a corporate gross margin of 53.6% in the second quarter of 2024, as compared to 27.8% in the second quarter 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. As our revenue continues to grow and fixed expenses are tightly managed. During the second quarter, adjusted EBITDA of $6.4 million for the quarter ended June 30, 2023, an increase of $38.1 million, or nearly 600%. Additionally, GAAP net income was $32.1 million for the quarter ended June 30, 2024, compared to a GAAP net loss of $6.4 million for the quarter ended June 30, 2023. Based on the robust $43.4 million of free cash flow generated in the second quarter and the significant adjusted EBITDA growth, the company's current net leverage ratio has organically improved to approximately 0.26x annualizing second 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. With that, I'll now turn the call back over to Adam for closing remarks.

Thank 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 an 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 zero, 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. Looking beyond 2025, we plan on leveraging our innovative commercial model, specialty manufacturing and R&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. Operator?

[Operator Instructions] Our first question comes from the line of Anthony Petrone with Mizuho Americas. Your line is now open.

How are you doing, Anthony?

Thank you, and congratulations, Adam, and to the rest of the ADMA Biologics team. Obviously, a very impressive performance. It's 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. Congratulations.

Thanks.

Maybe to start, we're counting now six consecutive quarters here of a beaten raise, Adam, and we're at the midpoint of 2024 and the company's been good in updating the 2-year forward outlook for '24 and '25. If we back out the accrual of $12 million in the quarter, that base top line rate is growing 58%. You're obviously levering the P&L to higher profitability levels. Give us a little bit of an idea of what maybe a longer range plan looks like beyond 2025. How sustainable is the mix shift to incentive? What 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 have a follow-up.

Thanks 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 six plus calendar quarters. We've got a great team here. The company's working very efficiently and honestly this is what happens I really believe when you make a good product that helps people. So 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. We feel like we've taken 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 ASCENIV has passed the 50% contribution for the mix of our therapy business unit products. And we think ASCENIV 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. As we've said, we've got IP protection into the mid 2030s 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 million, 2.5 million grams of IG in this plant. If all of it was incentive, you're looking at a $1 billion, $2 billion, maybe more than that in total peak revenues. Now, again, I've said this before, I'm not guiding to that. I'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. It'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 third-party supply contracts have been performing very, very well. But 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. Hopefully that answers your question.

Absolutely. And just a quick follow-up on ASCENIV. Maybe a little bit just on the patient experience, I think it would be helpful. In other words to a highly compromised patient, maybe give us an idea, like, how often are these patients hospitalized when they're not on ASCENIV? And 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 ASCENIV? Thanks again. Congratulations.

Thank you, Anthony. So, every immune-compromised 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, but the patients are immune-compromised. They've got primary immune deficiency, again one 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 life, 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. We quantified it in the prepared remarks. There are about 20,000 to 30,000 of the overarching 200,000 to 300,000, 400,000 patients with PI in the United States. We're targeting this 20% to 30%, and these are patients that really have failed multiple lines of therapy. They received other immunoglobulins and have not done well, they've had their dose increased. We'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're in a great position to capitalize on the great real world outcomes that doctors and patients have experienced with this and 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.

Thank you. One moment for our question, please. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open.

Hi, 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 ASCENIV product? Or is there something that could boost yield across the pipeline? How are you thinking about this?

Thanks, 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. BIVIGAM using normal source plasma, ASCENIV blended from normal source with the high titer plasma and NABI-HB is made from hyperimmune hepatitis B plasma. Yield enhancement specifically is being targeted to ASCENIV and BIVIGAM 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 bulk drugs. So 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 aligned 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 year of plasma that we collect. Especially for ASCENIV 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. And 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 plasma fractionation perspective with bringing a yield enhanced or a yield improved process to commercialization. So hopefully that answers your question.

Yes. 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 the field enhancement process?

Sure. 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 are modifying and improving with our process are comparable to what we have existing in our current FDA-approved BLAs for both ASCENIV and BIVIGAM. So, we'll submit data. We'll complete conformance slot 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. But again, we are really working very, very hard to get to a place where we could have an approval sometime late next year, early '26.

That's great. That helps a lot and thanks again.

Thank you. Send our regards to Kristen.

Thank 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.

Hi, guys, and my congrats as well on a really, really great quarter. Very impressive.

Thank you, Gary.

Yes, 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 bags 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?

All great questions. Thank you for them. I wrote [ph] 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, so I 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. Is there some room for upside? I mean, Adam Grossman, the man, thinks, 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 bulk 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. So although I have this, I guess, stigma of being highly conservative with financial guidance, that should stay for financial guidance. 20% is 20%, fair guide. 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.S. We know who the doctors are. We're involved and engaged deeply with 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. So we are working very, very hard within our own collection center network to incentivize RSD, high tier donors to come more frequently. We're working with our third-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, just 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. But 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. I 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. We make a good product that helps people. It's the best motivation. It's the best team builder. We feel really good about everybody does here. So we're going to be successful working as a team.

That's great. That was very helpful. And then just a couple more. Do you think physicians are considering using incentive as first line at all for PI patients that have co-morbid respiratory conditions, or is all the use still second line plus? And when you say incentive can contribute a significant majority over time, I know you chose those words carefully, but is that two-thirds, 75% more than that? What's a reasonable expectation there?

I 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 morbid PI patient. Adam Grossman does not believe that in PI you should use ASCENIV 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 ASCENIV 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 ASCENIV. And, I'm sure there aren't a lot of CEOs who are going to say things like that, but not every patient needs to be on ASCENIV. Some patients do very, very well on standard regular IGs. I mean, we've got patients on BIVIGAM. It's a great drug. It's a great drug. It's made the same way as ASCENIV. It's got the same impurity profile as ASCENIV. It's really a good, wonderful product. Some patients thrive on it, and we're very excited. But with respect to ASCENIV and the refractive co-morbid, 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, and 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 brother and companies in the space are all reporting increased utilization. We're very proud that we make our products the way we do and that we've got a truly differentiated and unique product with ASCENIV. So we're offering an alternative for doctors and patients who have tried everything that they can, increased dose, switch brands, sub-Q, IV. If those fail, come to ASCENIV. 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, third or fourth line therapy.

Okay, great. And congrats again, really very impressive. Thanks.

Thank you, Gary. Told you I wouldn't let you down.

Thank you.

All 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.

I just want to thank the admin 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 constituent. We Hope you’re pleased. We are 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.