NASDAQ:ADMA ADMA Biologics Q3 2023 Earnings Report $22.33 +0.60 (+2.76%) As of 04/24/2025 04:00 PM Eastern Earnings HistoryForecast ADMA Biologics EPS ResultsActual EPS-$0.01Consensus EPS -$0.01Beat/MissMet ExpectationsOne Year Ago EPS-$0.08ADMA Biologics Revenue ResultsActual Revenue$67.30 millionExpected Revenue$62.13 millionBeat/MissBeat by +$5.17 millionYoY Revenue Growth+63.70%ADMA Biologics Announcement DetailsQuarterQ3 2023Date11/8/2023TimeAfter Market ClosesConference Call DateWednesday, November 8, 2023Conference 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 Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 8, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to the ADMA Biologics Third Quarter 2023 Financial Results and Corporate Update Conference Call on Wednesday, November 8, 2023. 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 Blum, Head of Business Development and Corporate Strategy at ADMA Biologics. Operator00:00:34Please go ahead. Speaker 100:00:39Welcome, everyone, and thank you for joining us this afternoon to discuss ADNobiologics' financial results for the Q3 of 2023 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer and Brian Linz, Executive Vice President, Chief Financial Officer and General Manager of ADMA Bios Centers. During today's call, Adam will provide some introductory comments provide an update on corporate progress, and then Brian will provide an overview of the company's Q3 2023 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for your questions. Earlier today, we issued a press release detailing the Q3 2023 financial results and summarize certain achievements and recent corporate updates. Speaker 100:01:26The release is available on our website at www.admabiologics.com. Before we begin our 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 1995. All forward looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements, except as required by the federal securities laws. Speaker 100:02:28We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section of our 2022 annual report on Form 10 ks for the year ended December 31, 2022, as well as our quarterly report on Form 10 Q for the Q3 ended September 30, 2023, 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 the non GAAP financial measures to the nearest With that, I would now like to turn the call over to Adam Grossman. Adam? Speaker 200:03:15Thank you, Skyler, and welcome, everyone. We are pleased to present a number of firsts today with strong financial results for the Q3 of 2023, which underscore both our unwavering commitment to the continuity of patient care and steady financial execution for our stockholders. Total 3rd quarter revenues reached $67,300,000 representing an impressive 64% growth rate year over year. This rapid growth enabled a 98% quarter over quarter increase in adjusted EBITDA to $12,700,000 Furthermore, it gives me great pleasure to announce that for the first time in ADMA's history, we are profitable with GAAP net income reaching $2,600,000 during the Q3. We also generated positive free cash flow for the first time in corporate history, totaling $11,600,000 during the quarter. Speaker 200:04:16These milestone results are a testament to the efficiency of our organization and our relentless focus on maintaining top tier revenue growth, while judiciously managing expenses. We fully anticipate this positive trajectory will continue to drive earnings growth for the foreseeable future. Building on the momentum we've established this year, we've revised our total revenue guidance higher yet again for fiscal years 2023 through 2025. We now anticipate generating revenues during these periods of more than $250,000,000 $290,000,000 $335,000,000 respectively. Our company's success in carving a solid niche in the $10,000,000,000 immunoglobulin end market is a direct result of our innovative business model, diverse product portfolio and our targeted medical education, marketing and market access initiatives. Speaker 200:05:16We remain the fastest growing provider of immune globulin in the U. S. Marketplace with a specialization in treating immune deficient patients. Specifically, within the later line at risk primary immune deficient patient population segment, Ascentive continues to make significant inroads. In the Q3, leading Ascentive demand metrics hit all time highs across the board. Speaker 200:05:43We are seeing record new incentive patient starts and promising persistence and adherence trends as certain patients progress through their 3rd year on therapy. Equally encouraging, Ascenum's prescriber base is expanding and we anticipate will further compound the growth among existing prescribers and institutions. The value proposition of our product offerings was highlighted at the Annual 2023 IDWeek International Conference, where ADMA sponsored a symposium with 2 national clinical experts. First among these opinion leaders was Doctor. Alia Baluch, who discussed the heightened severity of respiratory viral infections or RBIs in immune compromised patients with up to 80% mortality risk in some cases. Speaker 200:06:35Doctor. Baluch emphasized the lack of Additionally, Doctor. Yolanda Walter highlighted the evolving approach to managing infectious diseases in immune compromised patients, focusing on RVI Management. She introduced Ascentiv, a unique intravenous immunoglobulin with increased antibody titer levels against respiratory pathogens. Doctor. Speaker 200:07:05Walter presented a case where Ascentive effectively managed recurrent respiratory infections that were unresponsive to standard immunoglobulin therapy and shared her own real world experience demonstrating the drug's clinical impact in this setting. All told, We are encouraged to see Ascentiv's unique product profile continuing to resonate in clinical practice and the real world setting. The therapy is accelerating demand trends and healthy growth attribution continually catalyze us to favorably rethink the ultimate size of the market opportunity. And we reiterate that we believe we are in the early innings here with the product's total potential. Turning to our 2024, 2025 corporate growth initiatives. Speaker 200:07:56All activities continue to progress as planned. We have successfully expanded Ascena's production to the 4,400 liter manufacturing scale, enhancing the product's margin, yield and capacity. We expect to realize these profitability benefits beginning late in Q4 and more materially in 2024. Additionally, our post marketing clinical studies are progressing well and may lead to label expansion with a potential pediatric age group if successful, further strengthening our product portfolio. Our excitement continues to build as we see the potential impact of our manufacturing Immunoglobulin Yield Enhancement Initiatives. Speaker 200:08:38During the Q3, we made significant strides in scaling up our processes and conducting laboratory bench scale runs and analysis. If ultimately successful, we believe enhanced production yields will be transformative in providing increased finished goods output, which would substantially increase Atmos peak revenues and earnings potential. While it's important to note that these opportunities won't have a potential financial impact until 2025, We cannot overemphasize our enthusiasm for the promising benefits this opportunity offers on both the top and bottom lines. On the plasma supply front, we are confident in our ability to meet the increased production forecast for our immunoglobulin portfolio. Our BioCenters collection network expansion in addition to our contractually secured third party supply contracts provide us with the flexibility needed to meet the growing end market demand for ADMA's immunoglobulin product portfolio. Speaker 200:09:43Currently, all 10 collection centers in our network are operational with 9 already FDA licensed and we anticipate achieving FDA licensure for our 10th and final collection center by the end of this year, with plasma supply self sufficiency also reflecting on ADMA's journey, it's become evident that our success is a direct result of the unwavering dedication and hard work exhibited by our exceptional staff members. Our remarkable transformation from a virtual clinical stage biotech company to one that is now cGMP compliant, has an end to end controlled supply chain now Thank you for your relentless efforts, which not only drive our accomplishments, but also create a meaningful impact in the lives of those who depend on us. It is the collective spirit and teamwork that truly make our workplace exceptional. We appreciate the commitment, passion and diligence that each team member brings to the table. It's this dedication that propels our organization's triumphs and empowers us to maintain complete control of operations in alignment with our core vision. Speaker 200:11:01We believe the solid foundation lays the groundwork for even greater success in the future. With this said, I'd now like Speaker 300:11:09to turn the call over to Brian for a review of the Q3 financials. Brian? Thank you, Adam. We issued a press release earlier today outlining our Q3 2023 financial results. And we'll be also issuing our Q3 10 Q later this afternoon, which we would encourage you to read in conjunction with our comments and discussion points we will make during today's call. Speaker 300:11:32I'll now discuss some of the key highlights from the Q3. As Adam mentioned earlier, total revenues for the 3 months ended September 30, 2023 were approximately $67,300,000 as compared to $41,100,000 during the 3 months ended September 30, 2022. This represents an increase of $26,200,000 or approximately 64%. The increase is attributed to higher sales of our immunoglobulin products driven by increased physician, payer and patient acceptance and utilization as well as the expansion of our customer base. The growth in product revenues during the quarter was partially offset by a $3,100,000 decrease in third party plasma sales from our BioCenters business segment, which was consistent with our expectations in the context of fulfilling our long term plasma supply agreement during the Q1 2023, while also providing a significant supply of normal source and high titer plasma to our Boca facility for the manufacturing of Ascentiv and BIVVIGAM as we migrate toward plasma supply self sufficiency. Speaker 300:12:42Gross profit for the 3 months ended 30, 2023 was $24,700,000 as compared to $9,700,000 for the same period of a year ago. And this represents an increase of $15,000,000 which is attributed to selling more of our higher margin product incentive during 2023 as compared to 2022. As a result, ADMA achieved a corporate gross margin of 36 0.6% in the Q3 of 2023 as compared to 23.5% in the Q3 of 2022. We believe the pathway is well paved to continue to grow gross profits over the coming periods. We are very pleased to report, as Adam mentioned earlier, that for the first time in corporate history, ADMA has achieved GAAP net income profitability and has generated first time positive operating cash flow. Speaker 300:13:36During the Q3 of 2023, GAAP net income reached $2,600,000 as compared to a GAAP net loss of $14,900,000 for the Q3 of 2022. Our operating cash flow for the 3 months ended September 30, 2023, totaled $12,000,000 increasing ADMA's cash on hand to $74,200,000 at the end of the Q3 of 2023. ADMA grew adjusted EBITDA to $12,700,000 for the 3 months ended September 30, 2023, as compared to an adjusted EBITDA loss of $6,100,000 the same period of a year ago. The improvement is driven primarily by increased sales, gross profit and fiscal operating management of our business segments. Based on Atmos' 3rd quarter adjusted EBITDA growth and cash generation, the company's current net leverage ratio has organically improved to an impressive 1.6x. Speaker 300:14:38We believe We anticipate the balance sheet will continue to strengthen over the coming periods, enabled by forecasted operating cash flow and growing adjusted EBITDA. Lastly, the Adva BioCenters network now consists of 9 FDA licensed plasma collection centers with our TENT Center operational and collecting plasma, which is pending FDA licensure anticipated by year end 2023. Additionally, in the same period, we forecast raw material plasma supply self sufficiency from all 10 of our centers. We remain encouraged by the real time improvements in donor foot traffic and collection volumes, which continue to achieve record all time highs and remain considerably above our organization's pre pandemic levels. With that, I will now turn the call back over to Adam for closing remarks. Speaker 300:15:30Thank you, Brian. Speaker 200:15:32ADMA's business prospects and company morale have never been higher. All Systems and teams are working in concert across our organization. We are committed to finishing 2023 on a high note and entering 2024 from a position of strength. 2023 with all of its challenges is truly proving to be a banner year for the entire organization. With Atmos cash holdings growing to $74,200,000 during the 3rd quarter and adjusted EBITDA annualizing at more than $50,000,000 we have established a strong foundation from which we anticipate continuous growth in both revenues and profits. Speaker 200:16:14Our ongoing corporate initiatives, particularly those centered on enhancing immunoglobulin manufacturing yields, have the potential to further accelerate ADMA's growth outlook and peak earnings potential. We believe that our financial achievements and growth outlook position ADMA as a distinguished player among standalone biopharma companies. With substantial barriers to entry in the United States immunoglobulin market and a robust intellectual property estate in the case of incentives. We are confident in our ability to deliver one of the most durable earnings growth stories in the biopharma industry. Our accomplishments in the Q3 of 2023 reflect our commitment to patient care, financial growth and market leadership. Speaker 200:17:02We are enthusiastic about the opportunities ahead and our dedication to delivering value to our stockholders and patients. Thank you for your continued support and trust in the company. We wholeheartedly appreciate those of you who have supported us through this journey, and we are committed to delivering for you in the periods to come. Your investment in ADMA helps to advance our mission to save lives and make high quality safe and efficacious products that help our friends, family and neighbors. Please donate plasma and help save lives. Speaker 200:17:34With that, we will now open up the call for your questions. Operator? Operator00:17:45Thank 8. As we compile the Q and A roster. And one moment please for our first question. Our first question will come from Christian sorry, Clusta of Cantor Fitzgerald. Your line is open. Speaker 400:18:12Hi, good afternoon and congrats on achieving the profitability. Came quite a few quarters ahead of your internal goals. So great job with that. Yes. So one question that we've been getting a lot lately and I think it'd be great to hear your comments on is just around IP and Protection around incentive. Speaker 400:18:34It's clearly served as a highly differentiated product contributing to a lot of success. So can you talk about What you're doing and what you've done to protect that, please? Speaker 200:18:46Absolutely. Thank you, Kristen. And it's been a while since I've actually been This question, this was a question from back in the days of the IPO. But we have issued patents for Ascentiv. And there's an entire IP estate, which covers the composition and the use of the product. Speaker 200:19:09The main IP is around the identification and selection of the plasma donors. The plasma pools, in order to ensure that there is some consistency in the anti RSV The antibody levels in the final product. So, this IP has been issued. I believe the patents run into 2,035. I did not anticipate the question, Kristen, but We do have IP protection here. Speaker 200:19:46And look, this is not a secret. A number of the things that we do are protected by trade secrets. A number of the things that we do By trade secrets, a number of the things that we do have issued IP for. But the drug in its form, formerly known as RI002, It was in clinical trials back in 2012, 2013, 2014. And Here we are in essentially almost 2024 and there is no competitive threat looking at a product like ASCENDIT with the unique antibody profile that this product has because of the unique donors that we use to make So we feel very good about our positioning. Speaker 200:20:30We feel very good about our place in the market. And again, there are no competitive threats that we're aware of that will be able to make the same compositional claims that we do with Ascentive. Speaker 400:20:46Okay. Thanks for that. And it wasn't that long ago that you were guiding to The Street that the peak revenues you think the company Produce would be over $250,000,000 $300,000,000 And now those numbers look small relative to what you're seeing potentially for 2425. So we ask this every earnings call. I recognize that. Speaker 400:21:11But I think it'd just be really helpful To truly understand like what has really changed over these last few quarters that give you such a high degree of confidence that you can even guide Revenues to The Street through 2025. Thanks again. Speaker 200:21:27Thanks, Kristen. You're asking a different question than you've asked before. I mean, What's changed? Nothing's changed. Everything's working. Speaker 200:21:36It's working the same way that it has been for the last couple of years. It's the medical education strategy. It's the marketing campaigns. It's the conversations with payers. It's our sales force. Speaker 200:21:49It's everybody that works in the company. It's all the little things that we do come together in such a way that people are responding positively. And I think that you see this With lots of products, you have early going back to my days as a marketing student in college, There are different life cycles that a product goes through and you have early adopters and you have these people who wait online to get the newest and greatest iPhone And they're the 1st users and they try all the apps and then the bugs get fixed and then more people start buying it and then you have the mass appeal. And I guess I would say that we're probably in that stage where the early adopters have worked very closely with our organization and we published a lot of articles around the around the real world clinical benefits that folks are seeing in these problematic immune deficient patients. We've been spending more money on marketing and medical education post COVID now that everybody's getting back into the real world. Speaker 200:22:54I mean, it's Yes, people are still getting sick, but I think people are not afraid to travel to these conferences. We're seeing record attendance at the shows that my teams are present at. And we've invested and built a medical educational speakers bureau that are all throughout the regions of the United States. And I think when patients do well And they are advocating and they are lending their stories to our websites where you can see new patient advocacy videos that have been posted online. I think it's just we provide an alternative and everything that we have said that we're going to do from the beginning, We're doing so nothing is changing. Speaker 200:23:38It's just, I think things are just coming together and they're coming together a little faster than what we anticipate. And I'm getting all these nice texts and I'm getting all these things that people want me to say all these things, but I am who I am, we are who we are. Our company, We're regular people just trying to do a good job and make good products that help people. So that's what we're doing here at ADMA. We're doing our best to provide you with reasonable guidance. Speaker 200:24:11Again, I've I I remember the Q2 of 2020 and we did not hit our top line number and I paid for it. I don't ever want that to happen again. I want My shareholders happy, I want my staff happy, and ultimately, I want my customers and my patients healthy and happy. So If you don't like the way that we give guidance, there's 4,000 other stocks you can buy. But for the time being, We think the guidance that we're putting out is fair. Speaker 200:24:50We think that it's certainly attainable guidance. And I think that that's what we want folks to make their investment decisions on, not these pie in the sky numbers that some folks Backtrack and have to explain why they don't hit them. You're asking me to explain why are we hitting numbers better than what we're saying. I've got a great team. I've got a great team around me. Speaker 200:25:15To all of you listening, it doesn't happen without each and every one of you. So don't screw around, give us an Speaker 400:25:258. Thanks, Adam. Speaker 200:25:27Thank you, Kristen. Safe travels. Operator00:25:31Thank you. And one moment please for our next question. The next question will come from Anthony Petrone of Mizuho Group. Your line is open. Speaker 200:25:46Hey, Anthony. How are Speaker 500:25:48you, Adam? Thanks and congratulations, Another good quarter. I was on the Q2 2020 earnings call and turned the page a few years and it's a huge difference. You have in the press release, Adam, that your prescriber base and patient base for Senev continues to grow. You're getting at net new prescribers as a common statistic out there for therapeutics companies as well as NRx Can you disclose, I guess, kind of where those are trending broad strokes? Speaker 500:26:27How many new Prescribers are coming on board each quarter, I guess, on average. And maybe what percent of this target, omorbid, Primary immune deficient market do you think is penetrated by Seniv at this point? It seems like we're just getting started here. And then I'll have a couple of thoughts for Brian. Speaker 200:26:49Thanks, Anthony. We are expanding the depth of our products penetration and our medical messaging. And that's really what is translating into this accelerated growth. There are more prescribers. And again, I think it goes back to the answer that I had to Christian's question around the early adopters And the prescribers that are out there, I mean, look, the best way to convince a physician to use a drug is another physician telling them My patients have done well on this drug. Speaker 200:27:24I'm playing it simple. I mean, I can hire all the reps and all the medical affairs people and I can put my name in lights all I want, but when a colleague is at a symposium or at a medical conference with another colleague and they're saying, hey, do you use this And they say, I actually do and I like it. That's the kind of advertising and promotion and benefit that You can't buy. It just happens because it's real world. So it's really that People are getting comfortable with the product. Speaker 200:28:00The price is certainly unique for an IG. It's priced on the higher end of the hyper immune, if you will, specialty IG scale. But I think that The benefits and the outcomes that they're seeing in the real world, people understand why it is what it is. It's special plasma that the drug is made from. And it's only made in this way by Adva. Speaker 200:28:28And I think that really it's the Grassroots marketing effort that we've taken to our story, to our commercial Throughout the commercial launch of the product that really is translating into increased Number of patients going on the product. We're really only having these conversations in the immune deficient world. That's where we And our time, that's where we focus, Anthony. So all the product use is really coming from primary and secondary immune deficient patients that are not doing well on IG, that have comorbidities, that are getting sick. And I think that once a doctor tries the product and sees results And that patient, they're faster to put their second patient on. Speaker 200:29:18And really what you're seeing is that because we have a larger number of prescribers, They're getting more comfortable in saying, you know what, I can advocate for these patients with the payers to get therapy because of these comorbidities And they're not afraid that they're not going to get reimbursed anymore. We've been I think we spent a lot of time over the last year and a half talking about durability And a lot of the analysts, including yourself, had questions. Well, Adam, how durable is this? Is this a one off quarter? How do you know this is going to happen every quarter, every quarter? Speaker 200:29:51And I think time, time is the only thing that I couldn't rush and demonstrate to all of you that It's these patients are like an annuity. They it's the razor blade model. You need a razor blade every month. You need your infusion every 3 to 4 weeks for the rest of your life. And if you do well on a incentive and if you're thriving on a incentive, Even though some of my market research suggested that people would come off therapy, they're not. Speaker 200:30:24They're staying on in multiple years of therapy and we're just seeing it compound. So hopefully that answers your question. But really, It's the clinicians. It's the clinicians that have said to my team, thank you. Thank you for making this product. Speaker 200:30:41Thank you You're giving us an option for these patients and they're doing well. That's what sells drugs. Speaker 500:30:50Absolutely. And the follow-up should be, Brian, maybe a little bit on gross margin here. Well above Our estimate in the quarter drove the EBITDA beat to some extent here, of course. So a couple of questions. One is, you referenced that at least there was some, incentive batches That we're successfully transitioned to 4,400 liter pool. Speaker 500:31:18Are we reading this right that, that product can be fully transitioned to $4,400,000 by the end of the year, early 'twenty four. And if so, what does that do to gross margin? Does that represent upside to this 40% to 50% target in the outer years? Thanks again and congratulations. Speaker 600:31:39Sure. Thank you, Anthony. So regarding Ascentive, we've certainly seen more upward mobility or For utilization of Ascentiv than we originally forecasted. And with regards to the 2,200 manufacturing batches of Ascentiv Transition and getting FDA approval not long ago to the 4,400 liter batches. They've pretty much sold out of the 2200s. Speaker 600:32:04The gross margin going from $2,200 to $4,400 is certainly very meaningful. I would say that historically, we were looking at 80% to 85% gross margin for Ascentive in that 2,200 liter range. Say now we're higher than 85% from closer to the upper 80s at some point in time, maybe even low 90% range for Ascentive as we continue to sell only 4,400 liter batches. Speaker 100:32:35Anthony, it's Skyler. To be clear though, in the 3rd quarter gross margin print of 36 point You're not seeing any monetization of the 4,400 liter Ascentive product, right? It's on a go forward basis. And It really materially will not kick in until the beginning of next year is the way that we think about it. Speaker 500:32:52All right. Very helpful. I'll get back in queue. Thanks. Operator00:32:57Thank you. One moment please for our next question. Our next question will come from Gary Nachman of Raymond James. Your line is open. Speaker 100:33:16Hi, Gary. Speaker 700:33:17Hi, guys. Good afternoon and very nice quarter. Speaker 200:33:20Thank you. Speaker 700:33:20So first question, How has your contracting been going with the big physician buying groups for both ASCENTIV and BIVVIGAM? And I want to get a sense of how much visibility you have on how much product you'll be able to supply them. Yes. I'm curious what you see looking into that funnel when you look out over the next 9 to 12 months? And then specifically, what was the mix for Ascentiv and BIVVIGAM in the Q3? Speaker 700:33:50And then I have a couple more. Speaker 600:33:52What was the mix? Do we know what? The mix, historically, we said we'd be in that 75%, 25%, 70%, 30% and then we would start looking at 60five-thirty 5 percent and we've really migrated To that sixty five-thirty five heading more towards sixty-forty standard margin, BIVVAM higher margin ascent of that sixty-forty mix right now. Speaker 200:34:17And I'll say, Gary, that, that is conservative. Let's see where we go in through 2024, but That's where we're seeing. I know in the past I've said, is there a chance that you get to fifty-fifty? Probably. Do I know when that is? Speaker 200:34:36No, I don't. I put my finger on it. No. But do we get there? Does incentive at some point in time potentially surpass The Vigam, probably. Speaker 200:34:45When do we get there? I don't know. But for the time being, for modeling purposes and the guidance that we feel comfortable with, We said seventythirty, sixtyfivethirty five is probably where we are and sixtyforty is where we're going to go. The first part of your question was regarding contracting and payer reimbursement. I mean, we're very pleased. Speaker 200:35:06I mean, you see the growth Between public and private payers, we're very, very happy. Our patient hub, we leverage the patient hub. It's proved very Effective and it's been very, very important in the getting new prescribers And providing patients with some assistance with their co pays and with other expenses as it may relate to their ASCENTIV or BIVVIGAM infusions. Again, incentives, incentives the drug for the appropriate at risk population. Again, they're staying on drug. Speaker 200:35:46They have these chronic persistent infections that they wind up clearing, but they have underlying bronchiectasis, They have underlying COPD, they have underlying asthma. On the Ascentive website, we go through a whole battery of all these different risk factors that patients may have. We're spending a lot of time talking about incentive here, but BIVVIGAM is a high flyer. I mean, it just As soon as it hits inventory, it's out the door. I mean, we've got so many patients on VIVIGAM right now and Keeping up with demand is certainly a challenge. Speaker 200:36:20And I'm sure all my staff listening right now is Chuckling, but we really can't keep it in stock. And we think a lot of this has to do with the fact that there's multiple years now of clinical experience. Payers are seeing that they're using less pre medication with these patients and there's less AEs and there are a lot of Interesting differentiating factors about our IG compared with our competitors and we think that that's really helping us Manage the payer, work with the payer well. And from a contracting perspective, again, we feel very, very pleased with our current payer access. Speaker 700:37:04Okay, great. And then, I mean, with the consistent positive EBITDA now for a few quarters And now the positive cash flow, at what point would you consider a debt refinancing? Is that high on your list Speaker 200:37:18Gary, everything is always high on my list. And I know you've been following the company, what is this, your 3rd call, 4th call now? We're always doing everything all the time. Let's just say that. I mean, we're not stupid. Speaker 200:37:32We see the markets there. Look at our financials. Look at how they've changed and evolved. I mean, we're having conversations all the time with all types of people. This is the answer that we give to you and this is the answer we give to All of our shareholders when we have our 1 on 1 calls. Speaker 200:37:48We're always having conversations and I'll just say stay tuned. We will do the right thing for this business as I believe that we've done since its founding. And It can only improve from where we are. And I think that we finally flipped the pages, right, Brian, on EBITDA and on net income and These are the Speaker 600:38:12things banks want to see, 3 quarters of positive EBITDA, total assets $350,000,000 1st quarter of net income, positive cash flow. These are things that lenders, banks like to see certainly, and we're going to do Everything we can, as Adam mentioned, to look at the cost of capital, look at this interest rate that has grown over the year. We refinanced in May, lowered the overall interest rate 100 basis points. We certainly think there's opportunities to Do the same or if not more in the future as our financials continue to improve over time. Speaker 700:38:53Okay, great. And last question is just on the patients. What are you doing specifically to try and activate Patients, 1, 1st in terms of the donor supply, just to get more donors, specifically for incentives. Are you increasing your incentives now that you see what kind of return you're getting? And then just Also in terms of patients that have been going through the IG treatment, and maybe they could then make Physicians aware as well. Speaker 700:39:26I'm curious if that's an important piece of the puzzle. Thanks. Speaker 200:39:30Absolutely. I mean, look, Patients advocate for themselves in 2023. If you're a smart patient and if you're somebody who wants to get better, What we see is that patients are out there advocating for themselves. Gary, if you haven't seen the new Additions to the Ascentive website, there are 2 patient advocates, who tell their story, and they talk about how they One patient talks about how their doctor said, hey, I learned about this drug at a conference and I think it might be right for you. The other She said, I learned about this drug, went to my doctor and I said, don't you think this is right for me? Speaker 200:40:12So I think that certainly is a big part of this. We have look, we're a smallish company, but we are spending more time marketing to patients. We are working much more closely and in a much broader capacity with the patient advocacy groups, Immune Deficiency Foundation, Jeffrey Modell Foundation, amongst others. And we think that that certainly is helping add to the growth for Senet. What was the first part Speaker 600:40:49of this question? And then Donors. Speaker 200:40:51Oh, donors. Yes. I mean, look, do we pay our donors more? I don't know if donors are listening. I don't think we are paying them that much more right now. Speaker 200:41:00There is a plethora of plasma donors out there today. Donor fees are coming down across the board. Brian certainly can speak more specifically to that in a moment. But, I've talked about this, I think, in past calls. And it's funny that you asked the question, Gary, because Maybe I had a management team meeting with everybody at the company this week and we're talking about how we've got testing up and running in house here for RSV donor screening And that certainly is going to help expedite the accessioning of these donors, the identification of which donors in our collection center network have the highest levels of neutralizing antibodies to RSV in the panel of respiratory pathogens that We look for and what I can tell you is that part of our supply chain robustness and owning our own centers is we can choose which donors we're collecting plasma from. Speaker 200:41:55So we're not saying that our 3rd party providers have not been great. They've been fantastic. And we love you all. We hope you keep selling us good high quality plasma. But if you work for Adva, I have more control over what you do, Plain and simple. Speaker 200:42:09I don't care about sending it to somebody else. I don't care if it has to go into that box. I want it where I want it and that's what I want. So, we can easily ensure that we get every single RSV high titer donor that we identify in testing. That is not something that I can say with our 3rd party vendors. Speaker 200:42:29We lose donors. Every unit of plasma that a donor that we've identified as an appropriate donor for an ASCENTI plasma pool, we have access to. So this was part of our Strategy, this was part of the philosophy was that, okay, if the drug does take off, if we do start selling tens of thousands of grams every month, if this is the way it is and we need all How are we going to really control? And it wasn't just the need of the source plasma, it was also because we know folks like you are going to ask us these questions. So Yes, we have full control over our plasma supply chain from a normal source perspective, but we also have full control over our supply chain from an RSV hyperimmune plasma perspective. Speaker 200:43:11And this coupled with the fact that we are testing in house The initial screens, we think that that's going to help us identify more donors and faster. We are continuing to work with our 3rd party laboratory. We plan to keep that 3rd party laboratory continuing to test forever because the one thing I've learned in my seat At Abbott Biologics' redundancy is the key to success. So even though we can do it better And more efficiently, we're going to continue to keep the assay up and running to ensure the continuity of supply and plasma collection. Speaker 600:43:48Just to add on a bit about the plasma centers, we're very pleased with the exponential growth. It was just a few years ago Back in 2020, when we embarked on a supply chain robustness initiative, where we only had one center, back in 2020, We had 3 centers that were collecting and 1 center that was FDA approved. Fast forward to 2023, we now have 10 centers collecting with 9 FDA approvals in the last center. We're hoping to receive FDA approval by the end of the year. So again, we're very pleased with the exponential growth. Speaker 600:44:21We'd like to thank our BioCenters employees for the ramp up and the expansion as well as our donors who go and donate because we couldn't do what we do without you. Speaker 200:44:33Absolutely. Speaker 500:44:35Excellent. Thank you for all that detail. Speaker 700:44:37That was really helpful. Speaker 200:44:40Thanks, Operator00:44:41Gary. Thank you. This will conclude the Q and A portion of the conference. I would now like to turn the conference back to the CEO, Adam Grossman, for closing remarks. Speaker 200:44:55Thanks, everybody. It's been a hell of a journey to get here. For those of you who've been here since the beginning, thanks for sticking around. For those of you who are joining us now for the first time, welcome. I really mean it when I say it to all my staff. Speaker 200:45:10I'm getting tons of text here. You all matter. You all make a difference in the lives of all these patients. To all the shareholders, nice text and messages that we've received, thank you very much. There's only one time in the company's history that you can say that you're first time net income positive. Speaker 200:45:26So this is The collaborative efforts of many, many people. Thanks for having faith in mine and my father's vision. It makes me a little bit emotional to think about it. But look, we're going to keep doing what we say. We're going to keep under promising and over delivering and Donate some plasma, take your vaccines, wash your hands, use Purell, keep the world a safe place and Operator00:46:04This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallADMA Biologics Q3 202300:00 / 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. (ADMA) the Best Multibagger Stock to Buy According to Billionaires?April 23 at 7:14 PM | insidermonkey.comNow I look stupid. Real stupid... I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. April 25, 2025 | Porter & Company (Ad)Stocks With Rising Relative Strength: BioNTech ADRApril 22 at 11:37 AM | msn.comWhy ADMA Biologics Inc. (ADMA) Performed Worst On Monday?April 22 at 1:35 AM | msn.comA life sciences and health care hub is growing in the Palm BeachesApril 18, 2025 | bizjournals.comSee More ADMA Biologics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like ADMA Biologics? 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 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to the ADMA Biologics Third Quarter 2023 Financial Results and Corporate Update Conference Call on Wednesday, November 8, 2023. 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 Blum, Head of Business Development and Corporate Strategy at ADMA Biologics. Operator00:00:34Please go ahead. Speaker 100:00:39Welcome, everyone, and thank you for joining us this afternoon to discuss ADNobiologics' financial results for the Q3 of 2023 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer and Brian Linz, Executive Vice President, Chief Financial Officer and General Manager of ADMA Bios Centers. During today's call, Adam will provide some introductory comments provide an update on corporate progress, and then Brian will provide an overview of the company's Q3 2023 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for your questions. Earlier today, we issued a press release detailing the Q3 2023 financial results and summarize certain achievements and recent corporate updates. Speaker 100:01:26The release is available on our website at www.admabiologics.com. Before we begin our 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 1995. All forward looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements, except as required by the federal securities laws. Speaker 100:02:28We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section of our 2022 annual report on Form 10 ks for the year ended December 31, 2022, as well as our quarterly report on Form 10 Q for the Q3 ended September 30, 2023, 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 the non GAAP financial measures to the nearest With that, I would now like to turn the call over to Adam Grossman. Adam? Speaker 200:03:15Thank you, Skyler, and welcome, everyone. We are pleased to present a number of firsts today with strong financial results for the Q3 of 2023, which underscore both our unwavering commitment to the continuity of patient care and steady financial execution for our stockholders. Total 3rd quarter revenues reached $67,300,000 representing an impressive 64% growth rate year over year. This rapid growth enabled a 98% quarter over quarter increase in adjusted EBITDA to $12,700,000 Furthermore, it gives me great pleasure to announce that for the first time in ADMA's history, we are profitable with GAAP net income reaching $2,600,000 during the Q3. We also generated positive free cash flow for the first time in corporate history, totaling $11,600,000 during the quarter. Speaker 200:04:16These milestone results are a testament to the efficiency of our organization and our relentless focus on maintaining top tier revenue growth, while judiciously managing expenses. We fully anticipate this positive trajectory will continue to drive earnings growth for the foreseeable future. Building on the momentum we've established this year, we've revised our total revenue guidance higher yet again for fiscal years 2023 through 2025. We now anticipate generating revenues during these periods of more than $250,000,000 $290,000,000 $335,000,000 respectively. Our company's success in carving a solid niche in the $10,000,000,000 immunoglobulin end market is a direct result of our innovative business model, diverse product portfolio and our targeted medical education, marketing and market access initiatives. Speaker 200:05:16We remain the fastest growing provider of immune globulin in the U. S. Marketplace with a specialization in treating immune deficient patients. Specifically, within the later line at risk primary immune deficient patient population segment, Ascentive continues to make significant inroads. In the Q3, leading Ascentive demand metrics hit all time highs across the board. Speaker 200:05:43We are seeing record new incentive patient starts and promising persistence and adherence trends as certain patients progress through their 3rd year on therapy. Equally encouraging, Ascenum's prescriber base is expanding and we anticipate will further compound the growth among existing prescribers and institutions. The value proposition of our product offerings was highlighted at the Annual 2023 IDWeek International Conference, where ADMA sponsored a symposium with 2 national clinical experts. First among these opinion leaders was Doctor. Alia Baluch, who discussed the heightened severity of respiratory viral infections or RBIs in immune compromised patients with up to 80% mortality risk in some cases. Speaker 200:06:35Doctor. Baluch emphasized the lack of Additionally, Doctor. Yolanda Walter highlighted the evolving approach to managing infectious diseases in immune compromised patients, focusing on RVI Management. She introduced Ascentiv, a unique intravenous immunoglobulin with increased antibody titer levels against respiratory pathogens. Doctor. Speaker 200:07:05Walter presented a case where Ascentive effectively managed recurrent respiratory infections that were unresponsive to standard immunoglobulin therapy and shared her own real world experience demonstrating the drug's clinical impact in this setting. All told, We are encouraged to see Ascentiv's unique product profile continuing to resonate in clinical practice and the real world setting. The therapy is accelerating demand trends and healthy growth attribution continually catalyze us to favorably rethink the ultimate size of the market opportunity. And we reiterate that we believe we are in the early innings here with the product's total potential. Turning to our 2024, 2025 corporate growth initiatives. Speaker 200:07:56All activities continue to progress as planned. We have successfully expanded Ascena's production to the 4,400 liter manufacturing scale, enhancing the product's margin, yield and capacity. We expect to realize these profitability benefits beginning late in Q4 and more materially in 2024. Additionally, our post marketing clinical studies are progressing well and may lead to label expansion with a potential pediatric age group if successful, further strengthening our product portfolio. Our excitement continues to build as we see the potential impact of our manufacturing Immunoglobulin Yield Enhancement Initiatives. Speaker 200:08:38During the Q3, we made significant strides in scaling up our processes and conducting laboratory bench scale runs and analysis. If ultimately successful, we believe enhanced production yields will be transformative in providing increased finished goods output, which would substantially increase Atmos peak revenues and earnings potential. While it's important to note that these opportunities won't have a potential financial impact until 2025, We cannot overemphasize our enthusiasm for the promising benefits this opportunity offers on both the top and bottom lines. On the plasma supply front, we are confident in our ability to meet the increased production forecast for our immunoglobulin portfolio. Our BioCenters collection network expansion in addition to our contractually secured third party supply contracts provide us with the flexibility needed to meet the growing end market demand for ADMA's immunoglobulin product portfolio. Speaker 200:09:43Currently, all 10 collection centers in our network are operational with 9 already FDA licensed and we anticipate achieving FDA licensure for our 10th and final collection center by the end of this year, with plasma supply self sufficiency also reflecting on ADMA's journey, it's become evident that our success is a direct result of the unwavering dedication and hard work exhibited by our exceptional staff members. Our remarkable transformation from a virtual clinical stage biotech company to one that is now cGMP compliant, has an end to end controlled supply chain now Thank you for your relentless efforts, which not only drive our accomplishments, but also create a meaningful impact in the lives of those who depend on us. It is the collective spirit and teamwork that truly make our workplace exceptional. We appreciate the commitment, passion and diligence that each team member brings to the table. It's this dedication that propels our organization's triumphs and empowers us to maintain complete control of operations in alignment with our core vision. Speaker 200:11:01We believe the solid foundation lays the groundwork for even greater success in the future. With this said, I'd now like Speaker 300:11:09to turn the call over to Brian for a review of the Q3 financials. Brian? Thank you, Adam. We issued a press release earlier today outlining our Q3 2023 financial results. And we'll be also issuing our Q3 10 Q later this afternoon, which we would encourage you to read in conjunction with our comments and discussion points we will make during today's call. Speaker 300:11:32I'll now discuss some of the key highlights from the Q3. As Adam mentioned earlier, total revenues for the 3 months ended September 30, 2023 were approximately $67,300,000 as compared to $41,100,000 during the 3 months ended September 30, 2022. This represents an increase of $26,200,000 or approximately 64%. The increase is attributed to higher sales of our immunoglobulin products driven by increased physician, payer and patient acceptance and utilization as well as the expansion of our customer base. The growth in product revenues during the quarter was partially offset by a $3,100,000 decrease in third party plasma sales from our BioCenters business segment, which was consistent with our expectations in the context of fulfilling our long term plasma supply agreement during the Q1 2023, while also providing a significant supply of normal source and high titer plasma to our Boca facility for the manufacturing of Ascentiv and BIVVIGAM as we migrate toward plasma supply self sufficiency. Speaker 300:12:42Gross profit for the 3 months ended 30, 2023 was $24,700,000 as compared to $9,700,000 for the same period of a year ago. And this represents an increase of $15,000,000 which is attributed to selling more of our higher margin product incentive during 2023 as compared to 2022. As a result, ADMA achieved a corporate gross margin of 36 0.6% in the Q3 of 2023 as compared to 23.5% in the Q3 of 2022. We believe the pathway is well paved to continue to grow gross profits over the coming periods. We are very pleased to report, as Adam mentioned earlier, that for the first time in corporate history, ADMA has achieved GAAP net income profitability and has generated first time positive operating cash flow. Speaker 300:13:36During the Q3 of 2023, GAAP net income reached $2,600,000 as compared to a GAAP net loss of $14,900,000 for the Q3 of 2022. Our operating cash flow for the 3 months ended September 30, 2023, totaled $12,000,000 increasing ADMA's cash on hand to $74,200,000 at the end of the Q3 of 2023. ADMA grew adjusted EBITDA to $12,700,000 for the 3 months ended September 30, 2023, as compared to an adjusted EBITDA loss of $6,100,000 the same period of a year ago. The improvement is driven primarily by increased sales, gross profit and fiscal operating management of our business segments. Based on Atmos' 3rd quarter adjusted EBITDA growth and cash generation, the company's current net leverage ratio has organically improved to an impressive 1.6x. Speaker 300:14:38We believe We anticipate the balance sheet will continue to strengthen over the coming periods, enabled by forecasted operating cash flow and growing adjusted EBITDA. Lastly, the Adva BioCenters network now consists of 9 FDA licensed plasma collection centers with our TENT Center operational and collecting plasma, which is pending FDA licensure anticipated by year end 2023. Additionally, in the same period, we forecast raw material plasma supply self sufficiency from all 10 of our centers. We remain encouraged by the real time improvements in donor foot traffic and collection volumes, which continue to achieve record all time highs and remain considerably above our organization's pre pandemic levels. With that, I will now turn the call back over to Adam for closing remarks. Speaker 300:15:30Thank you, Brian. Speaker 200:15:32ADMA's business prospects and company morale have never been higher. All Systems and teams are working in concert across our organization. We are committed to finishing 2023 on a high note and entering 2024 from a position of strength. 2023 with all of its challenges is truly proving to be a banner year for the entire organization. With Atmos cash holdings growing to $74,200,000 during the 3rd quarter and adjusted EBITDA annualizing at more than $50,000,000 we have established a strong foundation from which we anticipate continuous growth in both revenues and profits. Speaker 200:16:14Our ongoing corporate initiatives, particularly those centered on enhancing immunoglobulin manufacturing yields, have the potential to further accelerate ADMA's growth outlook and peak earnings potential. We believe that our financial achievements and growth outlook position ADMA as a distinguished player among standalone biopharma companies. With substantial barriers to entry in the United States immunoglobulin market and a robust intellectual property estate in the case of incentives. We are confident in our ability to deliver one of the most durable earnings growth stories in the biopharma industry. Our accomplishments in the Q3 of 2023 reflect our commitment to patient care, financial growth and market leadership. Speaker 200:17:02We are enthusiastic about the opportunities ahead and our dedication to delivering value to our stockholders and patients. Thank you for your continued support and trust in the company. We wholeheartedly appreciate those of you who have supported us through this journey, and we are committed to delivering for you in the periods to come. Your investment in ADMA helps to advance our mission to save lives and make high quality safe and efficacious products that help our friends, family and neighbors. Please donate plasma and help save lives. Speaker 200:17:34With that, we will now open up the call for your questions. Operator? Operator00:17:45Thank 8. As we compile the Q and A roster. And one moment please for our first question. Our first question will come from Christian sorry, Clusta of Cantor Fitzgerald. Your line is open. Speaker 400:18:12Hi, good afternoon and congrats on achieving the profitability. Came quite a few quarters ahead of your internal goals. So great job with that. Yes. So one question that we've been getting a lot lately and I think it'd be great to hear your comments on is just around IP and Protection around incentive. Speaker 400:18:34It's clearly served as a highly differentiated product contributing to a lot of success. So can you talk about What you're doing and what you've done to protect that, please? Speaker 200:18:46Absolutely. Thank you, Kristen. And it's been a while since I've actually been This question, this was a question from back in the days of the IPO. But we have issued patents for Ascentiv. And there's an entire IP estate, which covers the composition and the use of the product. Speaker 200:19:09The main IP is around the identification and selection of the plasma donors. The plasma pools, in order to ensure that there is some consistency in the anti RSV The antibody levels in the final product. So, this IP has been issued. I believe the patents run into 2,035. I did not anticipate the question, Kristen, but We do have IP protection here. Speaker 200:19:46And look, this is not a secret. A number of the things that we do are protected by trade secrets. A number of the things that we do By trade secrets, a number of the things that we do have issued IP for. But the drug in its form, formerly known as RI002, It was in clinical trials back in 2012, 2013, 2014. And Here we are in essentially almost 2024 and there is no competitive threat looking at a product like ASCENDIT with the unique antibody profile that this product has because of the unique donors that we use to make So we feel very good about our positioning. Speaker 200:20:30We feel very good about our place in the market. And again, there are no competitive threats that we're aware of that will be able to make the same compositional claims that we do with Ascentive. Speaker 400:20:46Okay. Thanks for that. And it wasn't that long ago that you were guiding to The Street that the peak revenues you think the company Produce would be over $250,000,000 $300,000,000 And now those numbers look small relative to what you're seeing potentially for 2425. So we ask this every earnings call. I recognize that. Speaker 400:21:11But I think it'd just be really helpful To truly understand like what has really changed over these last few quarters that give you such a high degree of confidence that you can even guide Revenues to The Street through 2025. Thanks again. Speaker 200:21:27Thanks, Kristen. You're asking a different question than you've asked before. I mean, What's changed? Nothing's changed. Everything's working. Speaker 200:21:36It's working the same way that it has been for the last couple of years. It's the medical education strategy. It's the marketing campaigns. It's the conversations with payers. It's our sales force. Speaker 200:21:49It's everybody that works in the company. It's all the little things that we do come together in such a way that people are responding positively. And I think that you see this With lots of products, you have early going back to my days as a marketing student in college, There are different life cycles that a product goes through and you have early adopters and you have these people who wait online to get the newest and greatest iPhone And they're the 1st users and they try all the apps and then the bugs get fixed and then more people start buying it and then you have the mass appeal. And I guess I would say that we're probably in that stage where the early adopters have worked very closely with our organization and we published a lot of articles around the around the real world clinical benefits that folks are seeing in these problematic immune deficient patients. We've been spending more money on marketing and medical education post COVID now that everybody's getting back into the real world. Speaker 200:22:54I mean, it's Yes, people are still getting sick, but I think people are not afraid to travel to these conferences. We're seeing record attendance at the shows that my teams are present at. And we've invested and built a medical educational speakers bureau that are all throughout the regions of the United States. And I think when patients do well And they are advocating and they are lending their stories to our websites where you can see new patient advocacy videos that have been posted online. I think it's just we provide an alternative and everything that we have said that we're going to do from the beginning, We're doing so nothing is changing. Speaker 200:23:38It's just, I think things are just coming together and they're coming together a little faster than what we anticipate. And I'm getting all these nice texts and I'm getting all these things that people want me to say all these things, but I am who I am, we are who we are. Our company, We're regular people just trying to do a good job and make good products that help people. So that's what we're doing here at ADMA. We're doing our best to provide you with reasonable guidance. Speaker 200:24:11Again, I've I I remember the Q2 of 2020 and we did not hit our top line number and I paid for it. I don't ever want that to happen again. I want My shareholders happy, I want my staff happy, and ultimately, I want my customers and my patients healthy and happy. So If you don't like the way that we give guidance, there's 4,000 other stocks you can buy. But for the time being, We think the guidance that we're putting out is fair. Speaker 200:24:50We think that it's certainly attainable guidance. And I think that that's what we want folks to make their investment decisions on, not these pie in the sky numbers that some folks Backtrack and have to explain why they don't hit them. You're asking me to explain why are we hitting numbers better than what we're saying. I've got a great team. I've got a great team around me. Speaker 200:25:15To all of you listening, it doesn't happen without each and every one of you. So don't screw around, give us an Speaker 400:25:258. Thanks, Adam. Speaker 200:25:27Thank you, Kristen. Safe travels. Operator00:25:31Thank you. And one moment please for our next question. The next question will come from Anthony Petrone of Mizuho Group. Your line is open. Speaker 200:25:46Hey, Anthony. How are Speaker 500:25:48you, Adam? Thanks and congratulations, Another good quarter. I was on the Q2 2020 earnings call and turned the page a few years and it's a huge difference. You have in the press release, Adam, that your prescriber base and patient base for Senev continues to grow. You're getting at net new prescribers as a common statistic out there for therapeutics companies as well as NRx Can you disclose, I guess, kind of where those are trending broad strokes? Speaker 500:26:27How many new Prescribers are coming on board each quarter, I guess, on average. And maybe what percent of this target, omorbid, Primary immune deficient market do you think is penetrated by Seniv at this point? It seems like we're just getting started here. And then I'll have a couple of thoughts for Brian. Speaker 200:26:49Thanks, Anthony. We are expanding the depth of our products penetration and our medical messaging. And that's really what is translating into this accelerated growth. There are more prescribers. And again, I think it goes back to the answer that I had to Christian's question around the early adopters And the prescribers that are out there, I mean, look, the best way to convince a physician to use a drug is another physician telling them My patients have done well on this drug. Speaker 200:27:24I'm playing it simple. I mean, I can hire all the reps and all the medical affairs people and I can put my name in lights all I want, but when a colleague is at a symposium or at a medical conference with another colleague and they're saying, hey, do you use this And they say, I actually do and I like it. That's the kind of advertising and promotion and benefit that You can't buy. It just happens because it's real world. So it's really that People are getting comfortable with the product. Speaker 200:28:00The price is certainly unique for an IG. It's priced on the higher end of the hyper immune, if you will, specialty IG scale. But I think that The benefits and the outcomes that they're seeing in the real world, people understand why it is what it is. It's special plasma that the drug is made from. And it's only made in this way by Adva. Speaker 200:28:28And I think that really it's the Grassroots marketing effort that we've taken to our story, to our commercial Throughout the commercial launch of the product that really is translating into increased Number of patients going on the product. We're really only having these conversations in the immune deficient world. That's where we And our time, that's where we focus, Anthony. So all the product use is really coming from primary and secondary immune deficient patients that are not doing well on IG, that have comorbidities, that are getting sick. And I think that once a doctor tries the product and sees results And that patient, they're faster to put their second patient on. Speaker 200:29:18And really what you're seeing is that because we have a larger number of prescribers, They're getting more comfortable in saying, you know what, I can advocate for these patients with the payers to get therapy because of these comorbidities And they're not afraid that they're not going to get reimbursed anymore. We've been I think we spent a lot of time over the last year and a half talking about durability And a lot of the analysts, including yourself, had questions. Well, Adam, how durable is this? Is this a one off quarter? How do you know this is going to happen every quarter, every quarter? Speaker 200:29:51And I think time, time is the only thing that I couldn't rush and demonstrate to all of you that It's these patients are like an annuity. They it's the razor blade model. You need a razor blade every month. You need your infusion every 3 to 4 weeks for the rest of your life. And if you do well on a incentive and if you're thriving on a incentive, Even though some of my market research suggested that people would come off therapy, they're not. Speaker 200:30:24They're staying on in multiple years of therapy and we're just seeing it compound. So hopefully that answers your question. But really, It's the clinicians. It's the clinicians that have said to my team, thank you. Thank you for making this product. Speaker 200:30:41Thank you You're giving us an option for these patients and they're doing well. That's what sells drugs. Speaker 500:30:50Absolutely. And the follow-up should be, Brian, maybe a little bit on gross margin here. Well above Our estimate in the quarter drove the EBITDA beat to some extent here, of course. So a couple of questions. One is, you referenced that at least there was some, incentive batches That we're successfully transitioned to 4,400 liter pool. Speaker 500:31:18Are we reading this right that, that product can be fully transitioned to $4,400,000 by the end of the year, early 'twenty four. And if so, what does that do to gross margin? Does that represent upside to this 40% to 50% target in the outer years? Thanks again and congratulations. Speaker 600:31:39Sure. Thank you, Anthony. So regarding Ascentive, we've certainly seen more upward mobility or For utilization of Ascentiv than we originally forecasted. And with regards to the 2,200 manufacturing batches of Ascentiv Transition and getting FDA approval not long ago to the 4,400 liter batches. They've pretty much sold out of the 2200s. Speaker 600:32:04The gross margin going from $2,200 to $4,400 is certainly very meaningful. I would say that historically, we were looking at 80% to 85% gross margin for Ascentive in that 2,200 liter range. Say now we're higher than 85% from closer to the upper 80s at some point in time, maybe even low 90% range for Ascentive as we continue to sell only 4,400 liter batches. Speaker 100:32:35Anthony, it's Skyler. To be clear though, in the 3rd quarter gross margin print of 36 point You're not seeing any monetization of the 4,400 liter Ascentive product, right? It's on a go forward basis. And It really materially will not kick in until the beginning of next year is the way that we think about it. Speaker 500:32:52All right. Very helpful. I'll get back in queue. Thanks. Operator00:32:57Thank you. One moment please for our next question. Our next question will come from Gary Nachman of Raymond James. Your line is open. Speaker 100:33:16Hi, Gary. Speaker 700:33:17Hi, guys. Good afternoon and very nice quarter. Speaker 200:33:20Thank you. Speaker 700:33:20So first question, How has your contracting been going with the big physician buying groups for both ASCENTIV and BIVVIGAM? And I want to get a sense of how much visibility you have on how much product you'll be able to supply them. Yes. I'm curious what you see looking into that funnel when you look out over the next 9 to 12 months? And then specifically, what was the mix for Ascentiv and BIVVIGAM in the Q3? Speaker 700:33:50And then I have a couple more. Speaker 600:33:52What was the mix? Do we know what? The mix, historically, we said we'd be in that 75%, 25%, 70%, 30% and then we would start looking at 60five-thirty 5 percent and we've really migrated To that sixty five-thirty five heading more towards sixty-forty standard margin, BIVVAM higher margin ascent of that sixty-forty mix right now. Speaker 200:34:17And I'll say, Gary, that, that is conservative. Let's see where we go in through 2024, but That's where we're seeing. I know in the past I've said, is there a chance that you get to fifty-fifty? Probably. Do I know when that is? Speaker 200:34:36No, I don't. I put my finger on it. No. But do we get there? Does incentive at some point in time potentially surpass The Vigam, probably. Speaker 200:34:45When do we get there? I don't know. But for the time being, for modeling purposes and the guidance that we feel comfortable with, We said seventythirty, sixtyfivethirty five is probably where we are and sixtyforty is where we're going to go. The first part of your question was regarding contracting and payer reimbursement. I mean, we're very pleased. Speaker 200:35:06I mean, you see the growth Between public and private payers, we're very, very happy. Our patient hub, we leverage the patient hub. It's proved very Effective and it's been very, very important in the getting new prescribers And providing patients with some assistance with their co pays and with other expenses as it may relate to their ASCENTIV or BIVVIGAM infusions. Again, incentives, incentives the drug for the appropriate at risk population. Again, they're staying on drug. Speaker 200:35:46They have these chronic persistent infections that they wind up clearing, but they have underlying bronchiectasis, They have underlying COPD, they have underlying asthma. On the Ascentive website, we go through a whole battery of all these different risk factors that patients may have. We're spending a lot of time talking about incentive here, but BIVVIGAM is a high flyer. I mean, it just As soon as it hits inventory, it's out the door. I mean, we've got so many patients on VIVIGAM right now and Keeping up with demand is certainly a challenge. Speaker 200:36:20And I'm sure all my staff listening right now is Chuckling, but we really can't keep it in stock. And we think a lot of this has to do with the fact that there's multiple years now of clinical experience. Payers are seeing that they're using less pre medication with these patients and there's less AEs and there are a lot of Interesting differentiating factors about our IG compared with our competitors and we think that that's really helping us Manage the payer, work with the payer well. And from a contracting perspective, again, we feel very, very pleased with our current payer access. Speaker 700:37:04Okay, great. And then, I mean, with the consistent positive EBITDA now for a few quarters And now the positive cash flow, at what point would you consider a debt refinancing? Is that high on your list Speaker 200:37:18Gary, everything is always high on my list. And I know you've been following the company, what is this, your 3rd call, 4th call now? We're always doing everything all the time. Let's just say that. I mean, we're not stupid. Speaker 200:37:32We see the markets there. Look at our financials. Look at how they've changed and evolved. I mean, we're having conversations all the time with all types of people. This is the answer that we give to you and this is the answer we give to All of our shareholders when we have our 1 on 1 calls. Speaker 200:37:48We're always having conversations and I'll just say stay tuned. We will do the right thing for this business as I believe that we've done since its founding. And It can only improve from where we are. And I think that we finally flipped the pages, right, Brian, on EBITDA and on net income and These are the Speaker 600:38:12things banks want to see, 3 quarters of positive EBITDA, total assets $350,000,000 1st quarter of net income, positive cash flow. These are things that lenders, banks like to see certainly, and we're going to do Everything we can, as Adam mentioned, to look at the cost of capital, look at this interest rate that has grown over the year. We refinanced in May, lowered the overall interest rate 100 basis points. We certainly think there's opportunities to Do the same or if not more in the future as our financials continue to improve over time. Speaker 700:38:53Okay, great. And last question is just on the patients. What are you doing specifically to try and activate Patients, 1, 1st in terms of the donor supply, just to get more donors, specifically for incentives. Are you increasing your incentives now that you see what kind of return you're getting? And then just Also in terms of patients that have been going through the IG treatment, and maybe they could then make Physicians aware as well. Speaker 700:39:26I'm curious if that's an important piece of the puzzle. Thanks. Speaker 200:39:30Absolutely. I mean, look, Patients advocate for themselves in 2023. If you're a smart patient and if you're somebody who wants to get better, What we see is that patients are out there advocating for themselves. Gary, if you haven't seen the new Additions to the Ascentive website, there are 2 patient advocates, who tell their story, and they talk about how they One patient talks about how their doctor said, hey, I learned about this drug at a conference and I think it might be right for you. The other She said, I learned about this drug, went to my doctor and I said, don't you think this is right for me? Speaker 200:40:12So I think that certainly is a big part of this. We have look, we're a smallish company, but we are spending more time marketing to patients. We are working much more closely and in a much broader capacity with the patient advocacy groups, Immune Deficiency Foundation, Jeffrey Modell Foundation, amongst others. And we think that that certainly is helping add to the growth for Senet. What was the first part Speaker 600:40:49of this question? And then Donors. Speaker 200:40:51Oh, donors. Yes. I mean, look, do we pay our donors more? I don't know if donors are listening. I don't think we are paying them that much more right now. Speaker 200:41:00There is a plethora of plasma donors out there today. Donor fees are coming down across the board. Brian certainly can speak more specifically to that in a moment. But, I've talked about this, I think, in past calls. And it's funny that you asked the question, Gary, because Maybe I had a management team meeting with everybody at the company this week and we're talking about how we've got testing up and running in house here for RSV donor screening And that certainly is going to help expedite the accessioning of these donors, the identification of which donors in our collection center network have the highest levels of neutralizing antibodies to RSV in the panel of respiratory pathogens that We look for and what I can tell you is that part of our supply chain robustness and owning our own centers is we can choose which donors we're collecting plasma from. Speaker 200:41:55So we're not saying that our 3rd party providers have not been great. They've been fantastic. And we love you all. We hope you keep selling us good high quality plasma. But if you work for Adva, I have more control over what you do, Plain and simple. Speaker 200:42:09I don't care about sending it to somebody else. I don't care if it has to go into that box. I want it where I want it and that's what I want. So, we can easily ensure that we get every single RSV high titer donor that we identify in testing. That is not something that I can say with our 3rd party vendors. Speaker 200:42:29We lose donors. Every unit of plasma that a donor that we've identified as an appropriate donor for an ASCENTI plasma pool, we have access to. So this was part of our Strategy, this was part of the philosophy was that, okay, if the drug does take off, if we do start selling tens of thousands of grams every month, if this is the way it is and we need all How are we going to really control? And it wasn't just the need of the source plasma, it was also because we know folks like you are going to ask us these questions. So Yes, we have full control over our plasma supply chain from a normal source perspective, but we also have full control over our supply chain from an RSV hyperimmune plasma perspective. Speaker 200:43:11And this coupled with the fact that we are testing in house The initial screens, we think that that's going to help us identify more donors and faster. We are continuing to work with our 3rd party laboratory. We plan to keep that 3rd party laboratory continuing to test forever because the one thing I've learned in my seat At Abbott Biologics' redundancy is the key to success. So even though we can do it better And more efficiently, we're going to continue to keep the assay up and running to ensure the continuity of supply and plasma collection. Speaker 600:43:48Just to add on a bit about the plasma centers, we're very pleased with the exponential growth. It was just a few years ago Back in 2020, when we embarked on a supply chain robustness initiative, where we only had one center, back in 2020, We had 3 centers that were collecting and 1 center that was FDA approved. Fast forward to 2023, we now have 10 centers collecting with 9 FDA approvals in the last center. We're hoping to receive FDA approval by the end of the year. So again, we're very pleased with the exponential growth. Speaker 600:44:21We'd like to thank our BioCenters employees for the ramp up and the expansion as well as our donors who go and donate because we couldn't do what we do without you. Speaker 200:44:33Absolutely. Speaker 500:44:35Excellent. Thank you for all that detail. Speaker 700:44:37That was really helpful. Speaker 200:44:40Thanks, Operator00:44:41Gary. Thank you. This will conclude the Q and A portion of the conference. I would now like to turn the conference back to the CEO, Adam Grossman, for closing remarks. Speaker 200:44:55Thanks, everybody. It's been a hell of a journey to get here. For those of you who've been here since the beginning, thanks for sticking around. For those of you who are joining us now for the first time, welcome. I really mean it when I say it to all my staff. Speaker 200:45:10I'm getting tons of text here. You all matter. You all make a difference in the lives of all these patients. To all the shareholders, nice text and messages that we've received, thank you very much. There's only one time in the company's history that you can say that you're first time net income positive. Speaker 200:45:26So this is The collaborative efforts of many, many people. Thanks for having faith in mine and my father's vision. It makes me a little bit emotional to think about it. But look, we're going to keep doing what we say. We're going to keep under promising and over delivering and Donate some plasma, take your vaccines, wash your hands, use Purell, keep the world a safe place and Operator00:46:04This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.Read morePowered by