ADMA Biologics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 9, 2023

There are 7 speakers on the call.

Operator

Afternoon, and welcome to the Adma Biologics Second Quarter 2023 Financial Results and Corporate Update Conference Call on Wednesday, August 9, 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, Senior Director, Business Development and Corporate Strategy at Adma Biologics.

Operator

Please go ahead.

Speaker 1

Welcome everyone Thank you for joining us this afternoon to discuss ADMA Biologics Financial Results for the Q2 2023 and recent corporate updates. I am joined today by Adam Grossman, President and Chief Executive Officer and Brian Linz, Executive Vice President, Chief Financial Officer and General Manager of ADMA Biosciences. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brian will provide an overview of the company's Q2 2023 financial results. Finally, Adam will then provide some brief summary remarks Earlier today, we issued a press release detailing the Q2 2023 financial results and summarize certain achievements and recent corporate updates. This release is available on our website at www .admobiologics.com.

Speaker 1

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 as well as 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 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 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 quarter ended June 30, 2023, for a discussion of important factors that could cause actual results to differ materially from these forward looking statements.

Speaker 1

Please note that the discussion on today's call includes certain non GAAP financial measures, including adjusted EBITDA and adjusted net loss. A reconciliation of these non GAAP financial measures to the nearest comparable GAAP metric is available in our earnings release. With that said, I would now like to turn the call over to Adam Grossman. Adam? Thank you, Skyler.

Speaker 1

We're proud to report that we continue to rapidly grow our adjusted EBITDA base, which during the Q2 totaled $6,400,000 representing 160% sequential growth compared to the Q1 of 2023. This accomplishment was facilitated by an impressive 77% year over year increase in total revenues, which reached $60,100,000 in the 2nd quarter. This robust revenue growth has resulted in meaningful operating leverage underpinned by continued gross profit growth and disciplined management of operating expenditures. Based on the strong momentum established year to date, we are now raising fiscal year 2023 total revenue guidance to more than $240,000,000 upwardly revised from the $220,000,000 previously provided. Additionally, we remain confident in sustaining our growth trajectory in adjusted EBITDA throughout the remainder of 2023 and beyond.

Speaker 1

The encouraging business trends and compelling forward looking indicators have enabled ADMA to increase fiscal year 2024 and fiscal year 2025 total revenue guidance to at least $275,000,000 $325,000,000 respectively, and otherwise reiterate confidence in meeting or exceeding all profitability targets. In our view, ADMA's year to date financial results combined with the increased financial guidance place ADMA among only a select Few standalone biopharma companies with comparable revenue growth profiles and adjusted EBITDA generation. We believe this financial profile coupled with Aetna's unique asset scarcity value position the company amongst an elite biopharma peer group. We believe our continued success in the growing US10 $1,000,000,000 immunoglobulin end market is attributable to our innovative business model, unique product portfolio, targeted medical education efforts, and most importantly, Our core focus on treating underserved immune deficient patient populations. Since launching commercially, Aetna has been unwavering in its specialized focus on the primary immune deficient patient population.

Speaker 1

And we believe it is this concentration that has enabled Aetna to maintain its position as the fastest growing provider of immune globulin in the United States marketplace. During the second quarter, We treated a record number of primary immune deficient patients and gained strong market share, paving the way for promising new business prospects and expected go forward success in this market segment. Our evolving product mix continues to maintain its Favorable and strengthening trajectory in 2023. We believe the growth of Ascentive is driven by its unique composition and utilization among immunoglobulin therapies and its real world evidence to improve outcomes for at risk immune compromised patients with primary immunodeficiency or PI. The value proposition of Ascentiv within the immunoglobulin landscape was further articulated during our presence at the 2023 Clinical Immunology Society Annual Meeting, which took place during the Q2.

Speaker 1

At this meeting, Adam has sponsored a well attended medical education symposium presented by a nationally recognized key opinion leader, Who spoke about the real world challenges associated with respiratory viral infections or RVIs in patients with PI. Despite the availability of standard immunoglobulin therapies, experts noted that more than 90% of patients with PI continue to experience recurrent infections and associated complications. Clinical data presented at the CIS meeting highlighted That more than 1 third of this population continue to experience bronchiectasis, along with a rapid decline in lung function, adversely impacting outcomes and causing quality of life issues for patients and their families. Of particular significance, Certain patients with PI exhibit T cell defects and thus can experience prolonged RVIs that present risk for bacterial superinfections and poor outcomes. The real world case report presented an at risk patient that was successfully treated with Ascentiv.

Speaker 1

We are encouraged to see the unique product profile of Ascentiv continues to resonate in clinical practice real world settings. Along these lines, we are seeing signs of patient and prescriber persistence, bolstered by a record expansion of new accounts and reorder prescribing velocity among existing customers. We anticipate that this therapy will continue to capture and even greater share of our overall product portfolio mix over the coming periods and beyond. During the Q2 and recent periods, we made progress in advancing growth opportunities that will, if successful, further enhance our position in the market and increase our potential earnings power. One such opportunity is the recent successful advancement of multiple Ascentive batches through production at the expanded 4,400 liter manufacturing scale.

Speaker 1

This expansion is expected to improve the product's margin profile and increase plant production throughput capacity, supporting our forecasted rapid growth trajectory. We anticipate these benefits may be realized beginning later in 2023 and into 2024 and beyond. Secondly, the advancement of our yield enhancement initiatives is showing promise. The company has made progress with development scale and laboratory analyses with the potential to increase both peak revenues and margin potential upon and validation of commercial scale production and receipt of requisite regulatory approvals. The impact of yield enhancement initiatives, if successful, could provide for potentially transformative upside to the company's peak financial targets.

Speaker 1

Finally, Our ongoing post marketing clinical studies are progressing well and may provide label expansion opportunities further strengthening our product portfolio compared to our immunoglobulin As we have detailed in today's press release, I'd like to reiterate that the increased revenue guidance we have provided does not yet include any potential upside from these growth initiatives should they materialize. We look forward to updating the market on these developments. On the normal source and RSV plasma supply front, We believe we are well prepared to support all upwardly revised revenue forecast for our immunoglobulin portfolio. The rapid expansion of our BioCenters collection network in addition to our contractually secured third party supply contracts provide us with the financial and supply chain flexibility needed to meet our immunoglobulin portfolio's growing end market demand. Currently, all 10 collection centers in our network are operational, with 9 now FDA licensed, And we anticipate achieving complete FDA licensure before year end 2023 for our 10th collection center, after which we believe we will have established cost competitive plasma supply self sufficiency.

Speaker 1

As we reflect on our journey and the milestones we've achieved, it becomes evident that ADMA's success is a direct result of the unwavering dedication and hard work exhibited by our exceptional employees. It is with great appreciation that we recognize the commitment, passion and diligence that each team member brings to the table, driving our organization's triumphs and enabling us to take complete control of operations, aligning with our core vision. We believe this solid foundation paves the way for even greater expected success in the future. We extend our gratitude to the entire ADMA Biologics and ADMA Biocenter's teams Your relentless efforts you put in day in and day out. Your remarkable contributions not only fuel our accomplishments, but also make a meaningful difference in the lives of those who rely on us.

Speaker 1

It is the collective spirit and teamwork that make our workplace truly exceptional. With this said, I'd now like to turn the call over to Brian for a review of the Q2 2023 financials.

Speaker 2

Thank you, Adam. We issued a press release earlier today outlining our Q2 2023 financial results, And we will be also issuing our Q2 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. I will now discuss some of the key highlights from the Q2. As Adam mentioned earlier, Total revenues for the 3 months ended June 30, 2023 were approximately $60,100,000 as compared to $33,900,000 during the 3 months ended June 30, 2022. And this represents an increase of $26,200,000 or approximately 77%.

Speaker 2

The increase is attributed to our higher sales of our immunoglobulin products, driven by increased physician, payer and patient acceptance and utilization as well as expansion of our customer base. The growth in product revenues during the quarter was partially offset by a $1,400,000 decrease in 3rd party plasma sales from our BioCenters business segment, and this was consistent with our expectations in the context of fulfilling our long term plasma supply agreement during the Q1 of 2023. Our gross profit for the 3 months ended June 30, 2023 was $16,700,000 as compared to $7,800,000 for the same period of a year ago. And this represents an increase of $8,900,000 As a result of this increase, ADMA achieved a gross margin of 27.8% in the Q2 of 2023 as compared to 22.9 percent in the Q2 of 2022. Importantly, accounting for an estimated $2,100,000 impact on a second quarter cost of goods sold pertaining to an IT disruption, which the company took responsive steps to rapidly remediate And normal course production and operations have resumed across our business units, ADMA estimates Q2 2023 Gross margin would have been 31% to 32% on a normalized basis.

Speaker 2

We believe the pathway is well paved to continue to grow gross profits over the coming periods. Our consolidated net loss was $6,400,000 for the Q2 of 2023 as compared to $13,800,000 for the Q2 of 2022. The $7,400,000 decrease in net loss was mainly due to the narrowed operating loss of $8,700,000 attributable to the increased revenues, gross profit and the increase of interest income of $400,000 partially offset by the $1,700,000 increase in interest expense. Adjusting for $2,800,000 in total Of non recurring charges related to the IP disruption, our adjusted net loss was $3,600,000 for the Q2 of 2023, a significant period over period improvement. ADMA grew adjusted EBITDA to $6,400,000 for the 3 months ended June 30, 2023, as compared to an adjusted EBITDA loss of $6,300,000 the same period of a year ago.

Speaker 2

The adjusted EBITDA improvement was driven primarily by increased sales and gross profit. We anticipate continued adjusted EBITDA growth throughout this year and beyond. ADMA's balance sheet remains strong. At June 30, 2023, ADMA had working capital of 224 $300,000 primarily consisting of $161,800,000 of inventory, cash and cash equivalents of 62 point $5,000,000 $36,700,000 of accounts receivable. This was partially offset by current liabilities of $42,000,000 Lastly, our ADMA BioCenters network now consists of 9 FDA licensed collection centers with 1 final center operational and collecting plasma, which is pending FDA licensure anticipated for year end 2023.

Speaker 2

And 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 we remain considerably above our organization's pre pandemic levels. With that, I'll now turn the call back over to Adam for closing remarks.

Speaker 1

Thank you, Brian. The company's growth and business trends are stronger than ever, And we believe our forward looking visibility allows us to confidently meet or exceed our newly increased financial targets. With a solid foundation in our supply chain and commercial infrastructure, we anticipate maintaining best in class revenue growth and potentially achieving an ultimate margin profile at the upper bound amongst our IG peers. In the immediate periods ahead, We expect to grow adjusted EBITDA and advance towards net income profitability. We are additionally committed to thoughtfully pursuing new growth opportunities And we are optimistic about the potential they hold for further enhancing our profitability over the near and longer term.

Speaker 1

We are excited to build on the momentum of the Q2 of 2023 and to drive further success and stockholder value. Although ADMaths terminated its financial advisory agreement with Morgan Stanley, the evaluation of strategic business alternatives remains ongoing and a top corporate priority for the company. Thank you for your continued support and trust in the company. We look forward to our journey ahead. I would like to thank you, our stockholders, for your continued support as 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.

Speaker 1

Please donate plasma and help save lives. With that, I'd now like to open up your call for questions. Operator?

Operator

Thank you. Today's question and answer session will be conducted electronically. Our first question comes from Gary Nachman with Raymond James. Your line is open.

Speaker 3

Hi, guys. Good afternoon. Nice quarter and raised guidance.

Speaker 1

Good morning, Gary.

Speaker 3

Yes. No, it's good to be here. So Adam, maybe you could talk more about the uptake you're seeing with the incentive, Specifically, what types of patients are getting put on it? And what's the reimbursement status Given the higher price point for the product? And then also the persistence you're seeing for both the patients and the physicians that you mentioned, So what portion of the revenue is currently Ascentiv versus BIVVIGAM?

Speaker 3

And then what are some of your initiatives to expand That uptake would incentive even further.

Speaker 1

Thank you for the great questions. There's a lot there, so I hope I touch on everything. What I can say to answer one of your I think your third question first, Roughly about a third of the revenue is coming from our higher margin products. We're seeing sequential growth quarter over quarter. We're seeing increased uptake.

Speaker 1

We tried in the prepared remarks and the press release to emphasize, because we've been getting this question a lot from analysts, from investors, Who are these patients? And we're really trying very hard to delineate that these are primary immune deficient patients. These are people that are diagnosed with 1 or more forms of immune deficiency. Some patients may even be medically immune compromised. And these patients have comorbidities.

Speaker 1

They have other risk factors. They have T cell issues. They have bronchiectasis. They have an increased risk of Respiratory viral infections. These are patients who are typically on standard immunoglobulin therapy, but don't seem to do that well.

Speaker 1

They continue to have problems. They continue to miss days of work and school. The long story short is that Since incentive, I should say prior to incentive, there was no alternative for these patients. It was just standard IVIG switching from one brand to another. So Ascendiant really offers the first type of product where it's made in a unique way that's protected by our patents.

Speaker 1

We use Plasma collected from donors that are tested to have high tires to certain respiratory viral pathogens, then we blend this plasma by making A product that has a differentiated antibody profile. What I can tell you, Gary, is that the data that's out there in the public domain shows that we are Seeing improved outcomes in these patients. Patients are durable. They're staying on therapy for multiple years at this point in time. We're in our 3rd year since the commercial launch of the product and really it's been a grassroots effort here.

Speaker 1

And what we're seeing now is a more rapid uptake. You asked about payers and reimbursement. In the right patient types, we're not seeing challenges Patients that have documented persistent and chronic infections, patients that, cost the system a lot of money because they're hospitalized The pharmacoeconomic rationale is gaining momentum out there. And because every IVIG has a unique J code, Reimbursement is being received for the product. I can tell you that we are Penetrating existing accounts, once clinicians see the results in their problematic immune deficient patients, They are more willing to try the product in additional patients and we're seeing this rapid Utilization and a more rapid uptake quarter over quarter.

Speaker 1

We think that Ascentive is still in the early innings. As we look at the primary immune deficient Market, there's roughly 250,000 to 500,000 people diagnosed with 1 or more forms of primary immune deficiency and roughly somewhere between 10% to 30% of these patients we feel could be our target market. So there's tens of thousands of patients. So we feel that we Potentially haven't even scratched the surface. We're now making Ascentive at the 4,400 liter scale.

Speaker 1

So the margins that you're seeing for the product today, It's product that we made last year. So you're seeing our expenses today, but the revenue that we are generating It's from product that was made last year. And what I can tell you is that as we're looking at our yields, as our business is operating more efficiently as we're getting better, I don't just pat our employees on the back. They're doing a better job than they ever have, and we're spending less and we're gaining more yield, Gain more efficiency, controlling cost better. So, we think we've got wind at our backs.

Speaker 1

We feel really confident that the drug is doing what we intended. And maybe I'll just touch on this a little bit too that we've been focused in the primary immune deficient market since the company was founded. Our motto is advanced therapies for the immune compromised. This isn't something that we're just making up today just because of Where the status is and where the industry is, many of our larger competitors are now starting to talk about primary immune deficiency. We've only been talking about immune deficient patients since inception.

Speaker 1

It's why I founded the company. It's why Jerry and I put our money up To start this company, we recognize an unmet medical need in the immune deficient patient population 15 years ago. And we're seeing the benefits Of that, today, we really feel that we've been the vocal champion and this is something I've said on multiple conference calls. We're the vocal champion for the immune deficient population that typically doesn't have a voice. And we're very proud of the work that we're doing and the benefits that these problematic patients are seeing in the market.

Speaker 1

So it was a lot that you asked. I gave you a long answer. Hopefully, I touched on most Your question there.

Speaker 3

Yes. That was great. Thank you for all that detail. Just a quick follow-up. So When you consider the raised guidance for this year and then for 2024 and 2025, what are you factoring in the mix In terms of incentive and bivigam in that guidance, is it a third and 2 thirds?

Speaker 3

And then just put some context around The magnitude of potential upside from a greater mix shift to incentive and also the label expansion opportunities And then further yield enhancement. So are you limited in any way with your Plasma Supply, if you can achieve some of those other targets? Thanks.

Speaker 1

Great questions, also Gary. And what we've always said historically is that Our higher margin products, Ascentive and NaVY HB, historically, we've said a seventy-thirty Between BIVVIGAN being the primary revenue driver, and Ascentives and Navi being the Smaller share. We're seeing increased utilization of incentives. And what Brian and I have said in the last couple of calls is that We're seeing a move closer to that 60 five-thirty 5 split depending upon the quarter. We're growing on all sides.

Speaker 1

So it's not like fixed. But what I can tell you here is that, Is there a potential to get to a sixty-forty, maybe even fifty-fifty split in the out years? There's certainly a potential. Roughly about 10% of plasma donors have the antibody profile that we're looking for, for the plasma that's used as the starting material for Essentive batches. But being that we've got 10 collection centers open And collecting plasma, what I can tell you is that it's not just 10% of the plasma that we're collecting.

Speaker 1

We've got the power and the control to Choose which people come in to donate plasma that day. And we may run special bonuses for donors that have the antibody profile for Ascentive, we may run promotions where we pay them more. And what I can say is that, the plasma that we're collecting, for Ascentive, It's more than 10% of our overall collections. We're implementing strategies in house, which I've talked about on previous calls around accelerating testing, bringing some of the testing in house, which will accelerate turnaround time for identifying these donors, As well as reducing costs, but we're not paying our 3rd party labs to do this testing. That ultimately is going to lower our cost of goods and increase margins.

Speaker 1

We've always said that Ascentive is roughly an 80% margin product. We think, as we move into the future, it could be 90% plus. You touched on yield enhancement strategies. Again, that touches our entire manufacturing portfolio, all of our products. We're not prepared to pinpoint how much more yield we anticipate.

Speaker 1

But in my prepared remarks, I did say that we think this could be potentially transformative. So, to the upside, the financial guidance and the raise that we've given today does not contemplate Increased yields, it does not contemplate really anything greater than that seventy-thirty mix that I've been talking about. We're very conservative. I know you're just getting to know us, Gary, but the other analysts on the call have been dealing with me for a while. Our investors have been dealing with me for a while.

Speaker 1

We are intentionally conservative in our guidance. We like to set good expectations and we like So I do think that there is substantial potential for upside here. But things take time. Nothing moves fast in the world of biologics. We've got some work to do in order to get conformance batches made and stability data taken.

Speaker 1

And at the end of the day, we think that We've got substantial upside and profitability metrics here that are not yet contemplated in our guidance.

Speaker 3

Okay, great. I appreciate all that. Thanks and congrats.

Speaker 1

Thanks again, Gary.

Operator

One moment for our next question. Our next question comes from Anthony Petrone with Mizuho. Your line is open.

Speaker 4

Thanks. Hey, Adam. Thanks and good afternoon everyone. You guys congrats here, another great quarter. Really kind of Just looking at the history here now, I think 6 quarters of a beaten race.

Speaker 4

So it's great to see and congratulations to the team. Maybe Adam, we hosted an immunologist call a few weeks ago just exploring the use case for Eseniv And a few interesting data points come out of that call. One is, that in particular in this individual's practice, they are actually seeing Benefits in these patients where they were refractory to traditional immunoglobulin. So maybe From the company's standpoint and anecdotally, when you think about these complex immune deficient patients that are susceptible to follow on Infections, they're complex, they're not responding to immunoglobulins. What are you hearing from a broader set of your immunologists that are treating these patients.

Speaker 4

So that would be the first question. And the second question is, And one of the data points that came out of that call is perhaps there needs to be more physician education around the benefits of incentive in order to unlock really having this product reach more of these complex patients. And so What is the sort of go to market strategy here now that Ascentiv is sort of becoming a go to solution here? Are you increasing the sales efforts to reach more of these patients? And I'll have a follow-up for Brian.

Speaker 4

Thanks.

Speaker 1

Thanks, Anthony. Great questions. I appreciate your continued support. The easiest answer I can give you is that patients are doing very well on Senet. I mean, that's been the story since the beginning.

Speaker 1

And again, I think building That grassroots effort, 1 patient at a time, the durability of the drug, you see the increased revenues, you see the way That the financial metrics are playing out for the business. That doesn't happen when you don't have a product that isn't Doing what you promise and that's improving outcomes for these patients, full stop. I think that Parling it into the second part of your question, what's next, what's changing? We have affected lives. And to the ADMA staff that's on the call and others that are close to the company, I mean, we've all seen the emails.

Speaker 1

We've seen the Emails from the patients, we've seen emails from the prescribers, even the conversation with some of the payers, to be candid Where, yes, the drug costs more, but it costs more to collect this plasma. And it's hard to find these donors. And when we find them, we try to keep them. But We make the product in a very reliable, reproducible and consistent way. It's a product that is not as variable From an antibody profile perspective that you see with other immunoglobulins to these antibodies that are outside of what The FDA has in the CFR for IG around measles polio diphtheria.

Speaker 1

And what I can tell you is that patient outcomes, Patients are doing better. Something that we're moving towards and I think you'll see maybe by the end of the year, maybe beginning of next year, In our Marketing, Medical Affairs, Scientific Communications Group, we've got patients now who want to be ambassadors for the drug. And I think this is something that you see, in more mature drug companies where you've got These patients that have done so well that they raise their hand and say, hey, I'd like to tell my story. I'd like to talk about my journey. And I think this is something that we're seeing from a number of patients out there.

Speaker 1

And I think as we progress, furthering our medical efforts not only to the physician community, which you asked about, but it's also with the patients themselves, Spending more time with the patient advocacy groups, providing more resources and availability of information 2 patients that are dealing with primary immune deficiency and talking to them about alternatives that are out there in the market today. So I think these are things that you're going to see. We are growing our commercial force, not exponentially. I mean, We've always said that we don't need 50 reps across the country here. We've got a small Commercial team, it's probably pushing roughly 35, 40 people in total, and we've got a couple of open jobs And we are spending money where we need to.

Speaker 1

We're not looking just to put our name in lights for the hell of it, Anthony. We want meaningful spend that has real outcome. And I think with the medical education efforts that we're doing with the Scientific Symposia as we highlighted at the Clinical Immunology Society meeting, As we're doing in these regional speakers programs and we're rolling out a speakers bureau, I think that the physician to physician education is working extremely well. But I'm really most proud of the work that I've seen from our medical affairs and scientific Communications and marketing group around the patient advocates. And once that becomes available, we'll certainly let our analysts know, but This is stuff that will be in the public domain and folks will be able to hear the real world stories and treatment journeys Of people who are on regular IG, of people who were denied IG because they didn't meet all the criteria and then they start on IG and they don't do well and then they Suffer for a couple of years and then they go on incentive and all of a sudden they're back to work and school.

Speaker 1

And again, it's not just the patient, It's the patients' families, it's the caregivers and all of this matters. And Coupling on the comments that I made to Gary's question, I mean, we're really starting to see the benefits of founding Adna Biologics Going through the struggle that's been Adva. We're really seeing these benefits pay off and I got to tell you coming to work every day, It's a lot more fruitful because we're making that much of a difference in the lives of so many thousands of patients. BIVVIGAM We are the only company that I'm aware of in the U. S.

Speaker 1

That's making drug using centrifugation, not filter presses. And we think we're on to something here. Both BIVVIGAN and incentive product profile, safety profile is stellar. We're really proud of the products that we provide to the immune deficient patient population.

Speaker 4

That's very helpful. And just 2 quick follow ups, Back in here. One would be just on pipeline, just kind of curious, we haven't heard anything on subcutaneous versions BIVVIGAM and Ascentiv, is that in the cards at some point? And then Brian, just on plasma supply, We're at 10 centers in total, 9 have FDA clearance. Is 10 kind of the right number?

Speaker 4

Or when you look out over the next 2 to 3 years, do you think that, that, plasma network collection base grows beyond the 10 where we're at today? Thanks again. Congratulations.

Speaker 1

Thanks, Anthony. So I'll just start off by saying, look, we've got IP in our Armamentarium and when the time is right, we'll certainly let you know. But right now, we're laser focused on market penetration, Building brand penetration and awareness of Ascentive, maximizing yields, Finding ways to unlock more value for little expense. That's what we're focused on here. I can tell you that the focus here It's just driving what we already have that's working.

Speaker 1

It's continuing to penetrate into the primary immune deficient and the secondary immune deficient markets and grow what we know is working. We're making more product than ever at the 4,400 meter scale. This year was the 1st year that we've made batches and We made a couple of batches so far, but we're working on budgets for next year. We're looking at the production plan and it's going to be all 4,400 all the time. More plasma through this plant, getting unabsorbed down, making more drug, having more output and then you couple that with The yield enhancement strategies, bringing more Phil Finich in house, I mean, these are ways that we're going to improve our margin profile beyond anything that you and I have ever talked about Over drinks or otherwise, Anthony.

Speaker 1

And I'll tell you that I'm very excited. We are still in the early days here at Aetna and Being able to raise guidance to now 325 or more, I never thought in a 1000000 years we would be here. When we took this plant over and they had the warning letter, I never in a 1000000 years thought I'd have $60,000,000 quarters. This plant Under the prior management, never generated more than $55,000,000 in a year, and we're doing that in a quarter and we're just beginning. So That's what's next for us.

Speaker 1

What's next is to keep doing what we're doing, do it better, do it more efficiently to the admin staff on the call. I told you I was going to say this on the call and Up to you to make it happen, but I think it's the early days and you're going to start seeing Cash flow, as Mr. Wonderful likes to say, very, very soon. I'll let Brian answer the question on the centers.

Speaker 5

Sure. Thank you, Adam. So, Anthony, regarding your question on the number of plasma centers, our centers are performing much better than expected. We're seeing we're very encouraged by the positive trends, the momentum. I'll tell you, we're seeing daily and weekly record day collections.

Speaker 5

We're also seeing cost per meter efficiencies, in some areas lower donor fees, as I mentioned, higher collections. We're really focused On labor and center efficiencies, we don't we're not looking at building any more than 10 centers. All 10 centers are built. All 10 centers are collecting. As you saw in July, we received FDA approval for our knife center.

Speaker 5

We feel certainly encouraged of getting our TENF center approved By year end and for us, it's all about plasma supply self sufficiency and those goals that we set for ourselves in the beginning of 2023 We're certainly coming to fruition for the number of leaders that we're collecting and putting through the plant. And again, we're very pleased with how the centers are performing. And again, no further CapEx for the centers, no further build outs and we're in a place right now. As we look forward to the revised guidance revenue numbers,

Operator

One moment for our next question. Our next question comes from Kristin Klotzka with Cantor Fitzgerald, your line is open.

Speaker 6

Hi, everyone, and congratulations on another really solid quarter here. First question I have is, maybe something I didn't really fully appreciate about the story is that the KOL community and treating physicians are a lot more tight knit than I So just given that you've continued to showcase your data and findings and just the word-of-mouth around these positive case studies, wanted to ask How much of the treating community you estimate is aware of the added benefits that Ascentiv is showing here? And then looking into the next 2 years or so, anything beyond your guidance that you're working In terms of getting the word out more in terms of like conference appearances and you talked about these potential patient representatives as well.

Speaker 1

Sure. Thank you, Kristen, very much. And I think you were at you may have been at CIS, if I recall.

Speaker 6

I was, yes.

Speaker 1

So thanks for taking an interest there. But you see it look, there's a handful of KOLs, if you will, that control a large part of the PI population, but we think that there is headroom. We think that there are certainly many more clinicians out there, many more prescribers that are just learning about. Something that I was just thinking about as you were talking, we've also started running print ad campaigns, which is strange, right? This is the world of digital.

Speaker 1

My experience and what our market research tells us is that immunologists like to pick up the actual Journal of Clinical Immunology And a couple of other publications and they like to actually flip the paper. So we started running print ads and I think that that Speaks to the fact that Ascentiv is starting to be recognized. It's a brand name that is Synonymous with immune deficiency, I think it's something that we've really worked hard at Joining the name ADMA, the name Ascentiv with immune deficient population, but I do feel very confident that there is a We think that there is a Ton of penetration opportunities among the existing prescriber base. Remember, roughly about 10%, 20%, 30% of every prescriber's patient population As these comorbidities and as we get more data in the public domain, as we're publishing more data, As the pharmacoeconomic impact is starting to show even more benefits, we think that we're going to see existing growth at same store Pharmacies that we haven't yet tapped into. And I really do see upside there.

Speaker 1

I don't think it was your question, but someone else asked about subcutaneous, and I'll just touch on that for a second. While we have no intention today to go for a subcu route of administration. I want to say that there was a publication from another immunologist, KOL, who on their own, did a study and they administered Ascentiv in the subcutaneous route. I believe that that publication was at a European meeting. I don't recall which one, but I can get back to you on that.

Speaker 1

But What I can say is that, I think that that answers part of your question is that prescribers are Learning about the drug and they're starting to get more comfortable with the product and use it in novel ways. So we feel good that there's a lot of room for us to grow. Hopefully that answers the question.

Speaker 6

Yes, it does. Thanks. And then you noted with the Seniv that you're not really having too many challenges, but I'm curious if you can comment on the trends among the provider level in terms of is it pretty consistent on a Provider basis and then how do you work with those providers that ask you more questions perhaps are a little bit more on the hesitant side?

Speaker 1

We've got a great market access team, got a great patient assistance program. I mean The data is out there. I mean many IVIGs, I want to say, I'm forgetting the data, I said it so many times. I want to say 70%, 80% of all IG requires a prior authorization anyway, whether it's on label or evidence based. So It's not unheard of for the payers to require a whole bunch of information from the prescriber and the treater for the product.

Speaker 1

Again, in the right patient population with the right comorbidities and risk factors, we're seeing Payer acceptance of the product in the right patient type. If you ask for the product for a patient that doesn't need the product, they're not going to get it. The mix between public and private is about a fifty-fifty split, but the value proposition is resonating. Our coverage is quite encouraging actually. And I'll tell you at the end of the day, it's being used later In a patient's treatment journey, if you will, they failed 1, 2, 3, 4 different IVIGs.

Speaker 1

And after a payer has tried 4 different IVIGs, all their The patient has been hospitalized. They keep getting bacterial pneumonia. They're suffering. They try Ascendiv and we've never said, you've never heard me say, oh, Ascendiv is the best frontline therapy. I'm not going to say that because that's not what it's for.

Speaker 1

Incentive is the product. After you've failed everything else and you have nowhere else to turn, come to us. We're going to save your life. We're going to improve your life. And that's what we're seeing.

Speaker 1

And I think that analysts, investors, some people are like, That doesn't resonate, that doesn't compute to them and that's fine. But not everybody has to be a frontline therapy. And when you look at the margin profile of Ascentive, I don't care when the patients get on the drug. Come to the island that is ADMA. We're here for you.

Speaker 1

We've got plenty of product and inventory. We can produce as much as the market seems to need right now. And We're happy to trade BIVVIGAN batches for Ascentiv any day. And for the patients out there and the patient advocacy communities, We're committed to collecting more plasma and meeting the data and if this product is We're very pleased and happy to help. It's not lip service.

Speaker 1

I've been saying it for years. I say it to our team all the time. Why does it matter? It matters because the patients are counting on us. We are the 1st company to do something different.

Speaker 1

We're the 1st company to move the peg forward, which is what when I was down and out of my luck many, many years ago, one of our KOLs Said to me, Adam, you got to keep going because you're moving the peg forward. And that's what we do here at ADMA. So it's not a frontline therapy, Kristen, and I think that After you fail a couple of IG's, payers pay.

Speaker 6

Okay, great. Thanks. And I know you guys are reaching about 10 years since you IPO ed, so you should feel very proud about all the progress you've made to today. So congratulations on that.

Speaker 1

We're still here, still alive. With growing EBITDA and net income around the corner.

Operator

Thank you. Ladies and gentlemen, this will conclude our question and answer portion of the call. I'd like Turn it back over to Adam now for additional closing remarks.

Speaker 1

Thank you, everybody. Thanks for your interest, attention and time. I appreciate you dialing into the call. Again, I think we're still in the early innings. I think there's a lot of upside here and we appreciate your continued support.

Speaker 1

Donate plasma to help save lives. Visit adlibiocenders.com to visit 1 of our 10 collection centers that may be near you. And stay healthy and have a very great evening. We appreciate you.

Operator

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

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Earnings Conference Call
ADMA Biologics Q2 2023
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