ADMA BIOLOGICS, INC. Q1 FY2025 earnings call

• ADMA's vertically integrated US-based supply chain and domestic commercial footprint have been critical, providing uninterrupted operations despite global tariff tensions.
• FDA approval of the innovative yield enhancement production process, which is expected to provide 20% more bulk IG from the same starting plasma volumes.
• Substantial growth in total revenues, adjusted net income, and adjusted EBITDA for the first quarter of 2025.
• Raising guidance for 2025 and 2026, with total revenue guidance for 2025 increased to $500 million or more, adjusted EBITDA to at least $235 million, and adjusted net income to $175 million or more. For 2026, total revenue guidance is increased to $625 million or more, adjusted EBITDA to $340 million or more, and adjusted net income to at least $245 million.
• Authorized a stock repurchase program allowing ADMA to purchase up to $500 million of its common stock.
• Progress on the lead pipeline program SG-001, with anticipation of generating proof of concept animal data by year end.
• ADMA's product portfolio is insulated from government price negotiations affecting other pharmaceutical sectors.

Total reported revenue for the first quarter of 2025 was $114.8 million, compared to $81.9 million in the first quarter of 2024, representing a 40% year-over-year increase. Adjusting for voluntary product withdrawals, total first quarter 2025 revenues would have been $118.6 million, indicating approximately 45% year-over-year growth. The gross profit for ASCENIV in the first quarter of 2025 was $61.1 million, up from $39.1 million in the first quarter of 2024. The gross margin for the first quarter of 2025 was 53.2%, improving from 47.8% in the comparable 2024 quarter. Adjusted EBITDA for the first quarter of 2025 was $47.9 million, compared to $26.4 million in the first quarter of 2024, showing an 81% year-over-year growth. Adjusted net income for the first quarter of 2025 was $33.3 million, up from $17.8 million in the first quarter of 2024, representing an 87% year-over-year growth.

• For 2025, total revenue guidance is increased to $500 million or more, adjusted EBITDA guidance is increased to at least $235 million, and adjusted net income guidance is reaffirmed at $175 million or more.
• For 2026, total revenue guidance is increased to $625 million or more, adjusted EBITDA guidance is increased to $340 million or more, and adjusted net income guidance is increased to at least $245 million.
• Increased total annual revenue expected to be realized prior to 2030 to $1.1 billion or more, up from the prior guidance of $1 billion.

• Voluntary product withdrawals in the first quarter due to inherent adverse events experienced by patients, though these are one-time nonrecurring occurrences.
• Trade and tariff volatility, which ADMA is insulated from due to its vertically integrated US-based supply chain.
• Risks associated with forward-looking statements, as actual results may differ materially from expectations due to various factors detailed in SEC filings.
• Potential risks related to FDA review and approval for pipeline programs like SG-001.

Q: Thanks, good afternoon, everyone and congrats here on a really strong start to the year and the recent FDA clearance on yield enhancement. Intrigued by the guidance here, Adam, raising the range once again here. $10 million in 2025, $20 million next year. But importantly, not including yield enhancement, our understanding is you needed to manufacture I think at least several batches at the higher yield run rate to secure FDA clearance and that with FDA clearance you could release those into the marketplace. So maybe just to recap how much was prepared to secure FDA clearance and when do you think those lots could actually begin contributing to revenue?

A: Sure. Thanks, Anthony, very much. We appreciate the support. So you’re exactly right. In order to have this FDA prior approval supplement approved, we manufactured three conformance lots at the commercial scale, two were BIVIGAM, one are ASCENIV. We’ve expressly excluded this from 2025 guidance altogether. We take the same conservative approach to guidance that we always have. I feel confident that we should be able to have these lots labeled, packaged, and released. But we are looking at this conservatively. We want to sell down all of the, call it, the old process, the 4,400 liter scale produced product first. We want to make sure that all of that product is out of inventory. And based on forward looking demand trends for ASCENIV and BIVIGAM, we feel confident that we certainly have a good shot on goal. And you could see us take the same approach that we’ve always taken, which is when we have that visibility, we’ll increase guidance. And we feel very, very good about our position right now. We are currently manufacturing at the yield improvement scale. So we feel really good about that. We’re implementing that extremely rapidly, and hats off to the team here for getting it done. But same conservative approach, Anthony. We’d rather under promise and over deliver, and we feel really good about where guidance is for ’25. And ’26, we’ve taken a conservative approach to yield enhancement, again, coupled with the fact that we want to make sure that we sell out all the inventory at the old process, and you will see margins start to certainly expand rapidly throughout 2026. If everything goes well, 100% of what we’re going to sell in 2026 will be manufactured at the yield improvement scale. So if my commercial team is listening, get it on, pull it through the channel.

Q: Hi, this is Rick Miller on for Kristen. Thanks for taking our questions. Earlier this year, you were talking the ability through some of the new supply agreements to access around 250 centers for collection. Can you help us understand what percentage of these centers are currently contributing to the source plasma mix?

A: Thanks, Rick, very much. We appreciate your and Kristen’s support. With respect to the onboarding of these centers, I think substantially all of the centers are now sending in samples, and we are screening from them. We’ve really done a great job here internally. Again, hats off to our laboratory testing team for this. But we are collecting more plasma than our forecast, and we feel real good about this. That’s partially contributing to our increasing guidance for this year and next year. But we’re running on all cylinders. We are collecting more plasma than we anticipated. We’re making more ASCENIV batches. The first yield enhanced batch is an ASCENIV batch. So we feel real good about this. We are very, very pleased with how the supply is coming from our third party partners. And these contracts have really derisked the historical bottleneck and supply constraints, and we feel that we’re going be able to hit all the targets that we’re putting out there. And we certainly have shots on goal, easy shots, I think, to exceed what we are forecasting and guiding to today.

Q: Hi, Gary. Great. Thanks. And hi, and congrats on getting the manufacturing process approval. So knowing that you’ll be able to generate 20% more yield with your plasma, are you able to release more new patients from the queue at a faster pace? Or do you need to have the finished product on hand before you do that? So how do you envision managing that in terms of the patient queue? Maybe you could just speak more generally, Adam, just following on this about how that queue has been building in terms of demand for incentives and how long before you think you’ll be able to get to most of those patients? Like, is it one year, two years? How do you think that’s going to evolve?

A: Well, my first gut reaction to that part of it is I hope we get to a place where there is so much demand that we can never meet it. And we’re talking about expanding capacity and growing even bigger than we are today. And that we think with new revised top line guidance prior to January If we can get there and we believe that there are more patients out there, we’re very excited for that opportunity. I can tell you that we are releasing more product than ever before. We made more product late last year, as we said on previous calls, and we have that product available starting now basically. And we’ve seen some great, great demand trends as we enter the second quarter and ended the first quarter. And we’re releasing more drug. The patient queue still exists. There are still patients waiting in line for therapy. We’re seeing robust continuation of patients on drug, and we feel very good about our ability to have more supply in the market for ASCENIV and getting more patients on therapy. You’re going to see the accounts receivable grow, and you see that number as we end the first quarter. Think cash and receivables were about $171,000,000 just about $100,000,000 of receivables. And the majority of our sales continue to be from ASCENIV, as Brad said earlier. The mix shift continues to expand with incentive being the overwhelming majority of the revenue that we are generating. And we feel really, really good. AR grew because of the timing of lot releases. We had a number of lot releases come in from FDA in the March timeframe, and the product is being pulled through at a rapid clip. So hopefully that answers your question, but the queue remains. We are adding more patients every single week, and we feel good about it. Patients continue to do well on drug therapy, and they’re staying on drug for long periods of time.