ADMA Biologics (ADMA) 2026年第三季度财报电话会：ASCENIV推动利润率增长

ADMA Biologics 2026年第三季度业绩表现强劲，主要得益于ASCENIV需求加速增长、更优的产品结构以及生产收率的提升。营收同比小幅增长，而毛利率和利润增速则明显更快。

核心要点

• 第三季度营收为1.411亿美元，同比增长5%，环比增长13%。
• ASCENIV营收达1.247亿美元，同比增长31%，环比增长21%，主要得益于新患者用药开启、医生采纳范围扩大以及患者的持续复购需求。
• 毛利率升至71%，高于上年同期的56%，主要受到ASCENIV产品结构优化以及生产收率提升的支撑。
• 调整后EBITDA同比增长32%至7730万美元，同时调整后净利润增长约31%至5110万美元。
• ADMA重申2026年全年营收指引为至少5.3亿美元，并上调了调整后EBITDA和调整后净利润的最低指引预期。
• 公司共回购了1650万股股票，耗资1.814亿美元（于2026年前九个月），约相当于6.3%的2025年底已发行流通股。

核心财务业绩

研发费用约为450万美元，上年同期为150万美元，2026年第二季度为600万美元；销售、一般及行政费用约为2660万美元，环比基本持平。

业务与经营业绩

ASCENIV仍是核心增长引擎

管理层将ASCENIV的增长归因于医生采纳范围扩大、新患者用药开启、医学教育、已发布的真实世界证据以及商业医保覆盖范围增加。终端用户需求在公司此前探讨的2%至4%区间内持续按月增长，但各月数据有所波动。

原发性免疫缺陷病患者仍是主要增长来源。管理层表示，ASCENIV在约2.5万名患者的目标市场中的渗透率已超过此前公布的4%，该目标市场约占25万名更广泛原发性免疫缺陷病患者群体的10%。

进入第四季度，公司还报告了良好的分销商出货动能。管理层表示，商业医保准入依然广泛，报销条件保持稳定，且ASCENIV继续在很大程度上免受标准免疫球蛋白市场压力的影响。

ADMA将继发性免疫缺陷病视为长期机遇，但也承认该患者群体近期的增长慢于预期。

在11月举行的ACAAI年会上，ADMA计划展示来自127例病情复杂的原发性免疫缺陷病患者的真实世界疗效数据。分析发现，与开始使用ASCENIV治疗前12个月相比，用药后12个月内患者因感染导致的住院治疗、门诊医疗资源使用、口服抗生素使用及皮质类固醇使用均出现具有统计学意义的显著减少。

BIVIGAM持续面临竞争压力

BIVIGAM营收降至1540万美元，原因是标准免疫球蛋白的价格、渠道压力、激进折扣及竞品返利持续对市场造成影响。ADMA表示，公司将优先考虑可持续的商业化运营，而非盲目跟进激进的价格竞争。

尽管如此，管理层表示，进入第四季度后终端用户的使用情况出现了企稳迹象。公司预计，近期发表的关于血栓相关产品特性的研究将有助于确立BIVIGAM在学术上的差异化优势，但竞争阻力依然存在。

SG-001在获得FDA反馈后推进

10月下旬，ADMA就其在研肺炎球菌高免球蛋白候选药物SG-001的pre-IND资料包获得了FDA的建设性反馈。反馈内容涵盖了拟定的临床策略、生产计划以及产品检测方法。

公司计划将FDA的建议纳入最终方案，并准备提交IND申请。管理层虽未透露具体的IND申报日期，但表示预计将在2027年向投资者提供更为确定的临床、研发及监管时间表。

管理层认为，拟开展的研究可能会是一项简化的注册性III期临床试验。公司也继续将SG-001视为一项潜在的每年3亿至5亿美元营收机遇，尽管该项目仍处于研发阶段。

管理层业绩指引

管理层表示，该业绩指引基于ASCENIV的持续增长动能，并对竞争激烈的标准免疫球蛋白市场保持审慎预期。该指引并不依赖于该市场的全面复苏。

第四季度研发支出预计将升至约1000万美元，主要由于ADMA生产SG-001性能验证批次并产生额外的血浆及生产成本。

风险与关注要点

• BIVIGAM竞争：大幅降价促销、返利、临期库存以及新市场参与者，持续对标准免疫球蛋白的定价和渠道状况施加压力。
• 继发性免疫缺陷病接纳度：ASCENIV在该患者群体中的普及进展慢于管理层此前的预期。
• 应收账款：应收账款周转天数增至110天，高于ADMA设定的90至105天目标区间，主要受分销商下单时间点的影响。
• 营运资金时间点：应收账款达1.692亿美元。管理层表示，所有应收款项仍在持续收回，公司历史上从未出现过坏账。
• SG-001不确定性：ADMA尚未提供明确的IND申报或临床试验时间表，且管理层指出FDA在研发过程中可能会调整其立场。

分析师问答亮点

• ASCENIV需求：管理层表示增长基础广泛，但原发性免疫缺陷病仍是主要驱动因素。新处方医生、新患者用药开启以及持续复用支撑了第三季度的业绩表现及第四季度的出货动能。
• 患者依从性：公司表示患者持续接受ASCENIV治疗，内部数据显示有相当比例的患者用药时间至少达到一年。管理层将其形容为持续复用的复合基础。
• 支付方准入：ADMA表示第三季度ASCENIV的报销情况没有发生重大变化。预先授权流程仍然耗费较多资源，但管理层指出符合条件的商保病例通常都能获得报销覆盖。
• 美国免疫球蛋白市场：管理层估计美国市场可能以低至中个位数的百分比增长，同时强调ADMA所处的门诊替代场所输注细分市场竞争依然高度激烈。
• 麦克森与DSO：管理层仍预计，随着时间的推移，麦克森（McKesson）采购量的增长将有助于缩短DSO，但预计在2026年剩余时间内不会带来显著益处。
• SG-001支出与时间表：ADMA预计第四季度研发费用将大幅环比增加，但目前尚未提供2027年研发费用指引或具体的IND申报日期。

业绩电话会完整文字记录

完整财报电话会议逐字稿

管理层陈述

Operator

Good afternoon, and welcome to ADMA Biologics Third Quarter 2026 Financial Results and Business Update Conference Call on Wednesday, November 4, 2026.

[Operator Instructions] 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 the company. Please go ahead.

Unknown Executive

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the third quarter of 2026 and recent corporate updates.

I'm joined today by Adam Grossman, our President and Chief Executive Officer; and Terry Kohler, our Chief Financial Officer and Treasurer.

During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and Terry will provide an overview of the company's third quarter 2026 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions.

Earlier today, we issued a press release detailing our third quarter 2026 financial results, achievements, and recent corporate updates. The release is available on our website at www.admabiologics.com.

Before we begin our formal comments, I'll remind you that we will be making forward-looking statements during today's call that represent the company's intentions, expectations or beliefs concerning future events, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our 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. We refer you to the Disclosures Notice section in our earnings release we issued today and the Risk Factors section in our quarterly report on Form 10-Q for the quarter ended September 30, 2026, for a discussion of the important factors that could cause actual results to differ materially from these forward-looking statements.

Please note the discussion on today's call includes certain non-GAAP financial measures, including adjusted EBITDA, adjusted net income and adjusted basic EPS. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release, which is available on our website at www.admabiologics.com.

With that, I would now like to turn the call over to Adam Grossman. Adam?

Adam Grossman

Thank you. Good afternoon, everyone, and thank you for joining us. Our third quarter performance highlights two key items. First, we are seeing accelerating ASCENIV demand. And second, we are demonstrating our ability to translate commercial momentum into substantial earnings growth. Favorable product mix, yield enhanced manufacturing, and disciplined execution are driving expanding profitability and meaningful earnings per share growth. We believe these two facts show the enduring strength of our business and ability to create value for stockholders.

ASCENIV revenue reached $124.7 million, increasing 31% year-over-year and 21% sequentially. Total revenue grew 13% sequentially to $141.1 million, and corporate gross margin reached 71%. Year-to-date through September 30, 2026, the company has repurchased 16.5 million shares, representing approximately 6.3% of the shares outstanding at year-end 2025.

We continue to execute against our previously reported target of $200 million or more in total share repurchases during 2026. Terry will review the financial results and our capital allocation strategy in greater detail shortly. ASCENIV's momentum reflects underlying patient demand, supported by broader physician adoption, new patient starts and increasing end-user utilization. Favorable distributor reported pull-through continued into the fourth quarter, providing further confidence in the durability of ASCENIV's growth trajectory. We continue to experience strong momentum within the primary immunodeficiency patient population, where sustained growth in ASCENIV utilization is contributing to an increasingly durable and expanding foundation of recurring patient demand.

Importantly, we believe significant additional growth opportunities remain within secondary immunodeficiency patient populations, where recent growth has been moderate. However, we believe this population represents a potentially meaningful and largely untapped opportunity for ASCENIV. As awareness of ASCENIV's differentiated clinical profile continues to expand among treating physicians, supported by our focused medical education and commercial initiatives, coupled with the growing body of scientific evidence, we are optimistic that adoption within these patient populations could accelerate in coming periods, providing a potential additional catalyst for sustained long-term product growth.

We believe ASCENIV remains early in its penetration of later-line refractory and medically complex primary immunodeficiency patients. Its differentiated profile, expanding clinical evidence base support a significant long-term commercial opportunity.

Turning to BIVIGAM. Third quarter revenue was $15.4 million compared with $19.4 million in the second quarter as standard IG pricing and competitive pressures persisted. While reported BIVIGAM revenue declined sequentially, underlying end-user utilization showed encouraging signs of stabilization entering into the fourth quarter. We continue to prioritize sustainable commercial participation rather than matching aggressive competitor rebating and discounting.

Our strategies reflect the distinct opportunities for each product, expanding ASCENIV's adoption through clinical engagement and real-world health outcomes evidence, while supporting BIVIGAM through disciplined contracting, manufacturing quality and product-specific scientific differentiation. Our scientific evidence base continues to expand. At the upcoming ACAAI Annual Conference in November, we will be presenting real-world health outcomes data from 127 medically complex primary immunodeficiency patients, most of whom had previously received other immunoglobulin therapies.

Comparing the 12 months before and after ASCENIV initiation, the analysis identified statistically significant reductions in infection-related hospitalizations, outpatient health care utilization, oral antibiotic use and corticosteroid use. These findings add important evidence to physician and payer discussions regarding ASCENIV's role in treating appropriate patients.

Separately, recently published peer-reviewed research examining thrombosis-related product attributes represents an important advancement in ADMA's scientific differentiation strategy, with particular relevance to BIVIGAM's competitive positioning in the U.S. standard immunoglobulin market. As health care providers increasingly evaluate product quality, manufacturing consistency and safety-related attributes alongside pricing and access, we believe these findings provide objective scientific evidence to support informed product evaluations and establish a more rigorous framework for assessing clotting-related activity and potential thrombotic risk across immunoglobulin products.

We believe the totality of these data underscores the strength of ADMA's manufacturing capabilities, enhances our commercial education efforts and provide an additional point of differentiation for BIVIGAM. We anticipate that scientific evidence will improve BIVIGAM's positioning in the competitive standard U.S. IG market, and this growing body of evidence will contribute to continued utilization stabilization and potential revenue growth for BIVIGAM in the coming periods.

During the third quarter, we advanced SG-001, our investigational pneumococcal hyperimmunoglobulin candidate through preclinical assay development and manufacturing readiness activities. ADMAlytics, our proprietary AI platform, has helped accelerate SG-001's development by using computational modeling, artificial intelligence and predictive analytics to forecast final titer values from limited experimental data. We believe this capital-efficient and data-driven approach can improve analytical efficiency and reduce laboratory testing requirements as we pursue SG-001's development using our established processes.

Additionally, we are encouraged by the constructive FDA feedback the company received in late October on our SG-001 pre-IND meeting package, which we believe represents an important milestone for the pipeline program. Notably, we received constructive feedback from the FDA regarding the proposed clinical development strategy, including key elements of the planned clinical study. Based on the FDA's feedback, we intend to incorporate the recommendations into the final clinical protocol and advance preparations for an IND submission. The FDA also indicated that our proposed assay would be acceptable for product testing, subject to appropriate validation.

Collectively, we believe this regulatory feedback supports advancing this program forward with a potentially efficient development pathway that leverages ADMA's established manufacturing capabilities and clinical development experience as we move SG-001 towards a registrational clinical trial. We continue to believe SG-001 represents a potential $300 million to $500 million annual revenue opportunity, and we will continue to keep investors informed as the program progresses in the normal and ordinary course.

We are reiterating our full year revenue guidance of at least $530 million and increasing our minimum expectations for adjusted EBITDA and adjusted net income. We believe continued ASCENIV momentum, disciplined execution and our financial position provide a strong foundation as we approach year-end. I'd like to thank our employees for their dedication to the patients which our products serve and continued execution across all functions of the business.

Terry will now provide comments and dive into the financials. Terry?

P. Terence Kohler

Thank you, Adam. I'll review our third quarter financial results, cash generation and capital allocation, followed by our outlook for the remainder of 2026. Third quarter revenue totaled $141.1 million compared to $134.2 million a year ago and $124.4 million in the second quarter, increasing 5% year-over-year and 13% sequentially.

ASCENIV revenue of $124.7 million grew 31% year-over-year and 21% sequentially and remained the primary driver of our performance. BIVIGAM revenue was $15.4 million compared with $23.8 million 1 year ago and $19.4 million in the second quarter. Pricing and channel pressures continue to weigh on reported revenue, although underlying end-user utilization showed encouraging signs of stabilization into the fourth quarter.

Our guidance does not depend on the broad recovery of the standard IG market. Gross profit increased to $99.9 million from $75.6 million a year ago and $86.3 million in the second quarter. Gross margin reached 71% compared to 56% a year ago and 69% in the second quarter, representing approximately 1,450 basis points of year-over-year expansion. Favorable ASCENIV mix and yield enhanced manufacturing were the principal drivers. Adjusted EBITDA was $77.3 million, increasing 32% year-over-year and 25% sequentially.

For the first 9 months, adjusted EBITDA totaled $198.8 million. Profitability growth exceeding revenue growth illustrates the operating leverage in our model. GAAP net income reached $49.9 million, increasing 37% year-over-year and 32% sequentially. Adjusted net income was $51.1 million, up approximately 31% both year-over-year and sequentially. GAAP basic EPS was $0.22, increasing 47% year-over-year and 29% sequentially.

Adjusted basic EPS was $0.23, increasing 44% year-over-year and 35% sequentially. Strong earnings growth, together with ongoing share repurchases is translating into meaningful growth in earnings per share. Research and development expense was approximately $4.5 million compared to $1.5 million a year ago and $6 million in the second quarter as we continued SG-001 development with lower sequential plasma collection activity.

Selling, general and administrative expense was approximately $26.6 million, essentially flat sequentially and supporting commercial initiatives. As of September 30, cash and cash equivalents totaled approximately $124.6 million. This liquidity provides flexibility to fund growth initiatives and return capital to stockholders, net leverage continues to be under half a turn. We continued repurchasing shares during the quarter. For the first 9 months of 2026, total stock repurchases amounted to $181.4 million with 16.5 million shares repurchased year-to-date through September, representing a reduction of 6.3% in ADMA shares outstanding versus the end of 2025.

Our capital allocation approach balances per share value creation with efficient investment in the core business. Cash and cash equivalents increased approximately $36.9 million during the first 9 months despite significant share repurchases. Cash from operations was $105 million year-to-date through September 30, 2026, an increase of over 600% versus the first 9 months of 2025. Accounts receivable totaled $169.2 million at the end of the quarter, with DSOs increasing in the period to 110 days, which is modestly higher than our previously discussed DSO target of between 90 to 105 days.

The driver of the DSO increase in the period was primarily the timing of orders from authorized distributors. We continue to collect all receivables with no history of bad debts, and we'll continue to work to drive DSOs back down into our target range over time.

Turning to our updated full year 2026 outlook. We continue to expect revenue of at least $530 million. We are increasing our minimum adjusted EBITDA guidance to at least $275 million from $265 million previously and our minimum adjusted net income guidance to at least $180 million from $170 million previously.

Our outlook reflects continued ASCENIV momentum and prudent assumptions for the competitive standard IG market. We believe ASCENIV growth, favorable mix, manufacturing efficiencies, and disciplined spending continue to generate substantial operating leverage. We believe our balance sheet and capital allocation strategy position us to execute through year-end and beyond.

With that, I'll turn the call back over to Adam.

Adam Grossman

Thank you, Terry. The third quarter demonstrates ADMA's ability to pair a differentiated commercial franchise with attractive margins, meaningful cash generation and growing earnings per share. Today, ASCENIV remains our primary growth engine. Increasing physician adoption, new patient starts and favorable pull-through into the fourth quarter support our confidence in continued commercial expansion, particularly among medical complex patients who may benefit from a differentiated treatment option.

For BIVIGAM, recent underlying utilization is encouraging even as standard IG pricing and channel conditions remain challenging. We intend to compete responsibly, supported by product-specific scientific evidence and consistent manufacturing execution. We believe the initiatives implemented will ultimately stabilize the BIVIGAM franchise and potentially return to product level revenue growth in the coming periods. Our evidence generation efforts support distinct commercial priorities.

ASCENIV's real-world health outcomes data help inform treatment decisions for medically complex patients, while the peer-reviewed thrombosis-related research provides additional scientific context for BIVIGAM evaluations. Both efforts reflect our commitment to evidence-led commercial execution.

We believe our yield-enhanced manufacturing process, diversified plasma sourcing and disciplined cost structure provide a durable foundation for profitability and cash generation. Alongside thoughtful capital returns, these advantages support our commitment to long-term per share value creation.

SG-001 represents an additional potential growth opportunity. We are advancing the program based on recently received constructive FDA feedback, and we believe it will be a capital-efficient program that leverages our existing production and laboratory infrastructure and ADMAlytics predictive modeling capabilities.

Looking ahead, our priorities are clear: sustain ASCENIV growth, navigate standard IG competition with discipline, convert earnings into cash, and allocate capital to its highest value uses. Our reiterated revenue outlook and increased minimum earnings guidance underscore our confidence in ADMA's profitability and the opportunities beyond 2026.

I'd like to thank our employees for their continued dedication to patients and operational excellence and our stockholders for their continued support.

Thank you for joining us on today's call. Operator, we're ready to take the questions.

Operator

[Operator Instructions] Our first question is from Ryan Deschner of Raymond James.

分析师问答

Ryan Deschner

Congrats on the quarter. Two for me. The first one, can you give us a little more color on what the main drivers behind the ASCENIV revenue beat in 3Q '26 were and how they contrast with the dynamics behind the weakness we saw a few quarters ago, and thoughts on going into the fourth quarter?

Adam Grossman

Sure. Thanks for the question. I mean, it really is just a culmination of all of our commercial efforts and medical education activities. You take all the real-world evidence that we've been publishing over the last year plus, coupled with enhanced medical education presence, some increases in our sales force presence throughout the year. We're really just very pleased with how the market is absorbing our data and looking at the real-world outcomes, and they want to experience this for their patients.

So we're seeing an increase in the number of prescribers. We're seeing an increase in new patient starts. And we continue to reiterate that we feel ASCENIV still has a long, long commercial life ahead of it, and we're early in the penetration curve. And we're just very proud of the fact that we make good products that help these patients that are refractive and that are failing standard IG products, and they have continued complications and chronic and persistent infections. And when they switch to ASCENIV, we're seeing tremendous improvements in this population. So I know I sound like a broken record, Ryan. I've said it before, but these are the results that happen when we make good products that help patients and deliver value to the payers.

Ryan Deschner

Appreciate it. What are your thoughts on how the day sales outstanding trajectory has progressed up to this point? What the impact going forward might be from the McKesson deal? And have your thoughts evolved at all on the DSO trajectory going forward?

P. Terence Kohler

Ryan, it's Terry. Thanks for the question. So very strong revenue growth, obviously, quarter-over-quarter, year-over-year. That split drove the accounts receivable up in the period. All of our receivables are good. All of our receivables continue to be collected. We collected all of our receivables in Q2. DSOs, as you know, they did increase in the period and they were above the target range that we have with the 90 to 105 days. We're going to continue to work to push those back into that target range.

In terms of McKesson, we spoke about obviously one of the ways for us to work those DSOs down over time is to grow our volumes to distributors like McKesson, who have better-than-average payment terms. McKesson has been a great partner. We still believe that the strategy is going to be effective. It may take a little bit longer than we previously expected. So we're not expecting a big impact to DSOs based on McKesson over the -- in the rest of 2026, but we will still continue to work to push DSOs down.

Operator

Our next question is from Anthony Petrone of Mizuho.

Anthony Petrone

Adam congrats on a nice print here. Maybe a couple on ASCENIV and one on BIVIGAM. Maybe just to dig into the rebound in ASCENIV a little bit more. Adam, on prior calls, you mentioned that secondary immune deficiencies are a growth driver. And I think you also referenced the idea that McKesson has a pretty big presence in oncology. And so you can see a comorbidity with oncology relative to a secondary primary immune deficiency. So to what extent is McKesson now in the numbers for ASCENIV? And are you actually seeing any uptake from the oncology channel? And then I'll have a follow-up on BIVIGAM.

Adam Grossman

Sure. Thanks for the question. We are really pleased with the performance of ASCENIV in the quarter. The main drivers of growth, as I stated during the prepared remarks portion, primary immune deficiency continues to lead the charge with growth, Anthony. Certainly, there is opportunity with respect to the secondary immune deficient population. In our prepared remarks, we said that it's slower than what we would have hoped or anticipated, but the opportunity still exists and it still remains. We're continuing to work through those channels, and we do expect on a go-forward basis that there is opportunity for ASCENIV to continue to grow and penetrate in that market. But the growth drivers have been across the entire immunocompromised patient landscape, primarily in the PI population.

Anthony Petrone

That's helpful. And then just going back to BIVIGAM, some of your competitors were out there. You had -- CSL was August and Grifols had a nice print as well, and they're still talking about an underlying immunoglobulin market globally that can sustain at least mid- to high-single digits. I guess at what point do you think the channel actually normalizes? And from the vantage point of ADMA Biologics, where do you see the underlying growth rate for the U.S. immunoglobulin market?

Adam Grossman

Sure. From a global perspective, I think what you're saying and what some of the other plasma companies are saying is there is unmet demand throughout the ex-U.S. markets. That's not a market that ADMA plays in, so I don't really have that much clarity there. But from the industry reports that we read and from speaking with folks throughout the industry, the global need for IG still is in an undersupply situation.

The U.S., from our vantage point, it's a little bit of a different story. Certainly, the market has more IG products than ever before. We play primarily in the outpatient alternate site infusion landscape. That's a highly competitive landscape right now. That's where a lot of the new entrants are trying to break in with their deep discounting. We've heard reports of short-dated products still persisting, although we're hearing that things are stabilizing.

From a BIVIGAM utilization perspective, we saw a nice rebound as we exited the third quarter into the start of the fourth quarter. And we're pretty optimistic that some of the short-dated material and this deep discounting that is impacting the ASP for some of these new entrant competing IG products, it's going to turn around and put BIVIGAM back into a position that we think it certainly should not drop below these levels, but we do think that there's opportunities to grow.

I've said it before, we feel that the market certainly is growing, albeit not where it's been historically. I think low-single digits is what we're hearing and what we're seeing. But I would defer to the companies that are selling tens of millions of grams into the market compared to ADMA's 1.5 million to 2 million grams into the market. But I think the market should grow, but we think it's going to be low maybe to mid-single digits.

Operator

Our next question is from Gary Nachman of Canaccord Genuity.

Gary Nachman

Nice quarter and really good to see the ASCENIV growth. Yes so on ASCENIV, just to quantify things a bit, how has the month-on-month utilization been relative to the 2% to 4% growth expectation you talked about previously? Has that been accelerating and also continuing into 4Q? And how much are you expanding use across physicians? And how many patients are currently on ASCENIV, giving us a sense of the increasing demand for it?

Adam Grossman

Sure. Thanks, Gary. ASCENIV end user pull-through demand has been growing on a month-to-month basis. We're still within the ranges that we stated previously. Some months are a little bigger than others, but across the balance of the calendar year, so far, we're very pleased with ASCENIV's growth trajectory. Year-over-year, it's up about 31%. I think we're looking at probably for the full year, it's going to be about 25%, maybe a little more than that for the full year. But again, this is all being driven by new patient starts, new prescribers.

I've said previously, Gary, it's a 25,000 patient target market. That's roughly 10% of the total 250,000 PI population. Previously, we've given statements that we penetrated about 4%. We're certainly above that number today. Regarding prescribers, we've got more prescribers as we exit the third quarter into the fourth quarter than we've ever had prescribing the drug previously. And that's a testament to our marketing med affairs, team that's out there generating all this data, getting these publications out there. And we want to thank all the clinicians and the infusion companies who we partner with on investigator-initiated work. We're very pleased with the data that is being published, and that's what's really driving uptake demand, prior authorization approvals. Very pleased with ASCENIV's commercial coverage, and we expect that to continue throughout the remainder of this year and into next year.

Gary Nachman

Okay. So yes, I was just going to follow-up. So there have really been no changes in the payer environment at all for ASCENIV with the pricing pressure that you're seeing in the standard IG market. And just to be clear -- so there are no more lingering impacts from the oversupply on the standard IG side with respect to ASCENIV or is there still maybe a little bit left there?

Adam Grossman

I'm just writing down your questions. So with respect to the payers, we have pretty broad access with respect to ASCENIV coverage on commercial plans. We are seeing growth in the commercial payer landscape. That's really what is helping to accelerate the ASCENIV utilization that we're seeing as reported from our distribution partners. But we don't see any changes during the third quarter to reimbursement.

We continue to have good negotiations. We continue to see good coverage across all geographies. And the prior authorization process is still the same. It's a process that requires the clinician, the infusion company, sometimes nurses and our field reimbursement team to get involved. But in appropriate use cases, we're not seeing any difficulties with getting commercial payer reimbursement. I have not said that the lingering pressures are over. What I am saying is that we are seeing certainly signs of stabilization with respect to BIVIGAM's utilization. We are still seeing in ASP reported declines from some of these new entrants and competing products. We are seeing discounting and steep rebating continuing. That's just not something that that ADMA is doing. You can see that in our reported ASP. ASP for ASCENIV and BIVIGAM are pretty stable entering into the fourth quarter here.

So the effects are still there. I think the short-dated product pressures, these new entrants selling that product into the channel, I'm hearing that there are signs that that is alleviating a little bit. But by no means am I saying that it's over and it's smooth sailing ahead. There still is a competitive headwind there for BIVIGAM. And that's part of the reason why we did the work, did the testing, put the data together and had the publication regarding BIVIGAM's safety profile. We think that that scientific differentiation and being able to now combat some of the messaging from some of the new entrant competitors, really puts BIVIGAM on an equal playing field, and we're very optimistic about a reversion for BIVIGAM into 2027. Hopefully, that answers.

Gary Nachman

Maybe I wasn't -- yes, no, I probably wasn't clear enough. I totally understand the dynamic with BIVIGAM. I just wanted to make sure that with utilization of ASCENIV, like that was one of the issues you had a couple of quarters ago with oversupply in the market.

Adam Grossman

ASCENIV continues to be largely insulated. We're really doing a very good job this year of carving out that true focused appropriate use case patients, and we are seeing good utilization, durable recurring patient demand month-over-month.

Gary Nachman

Okay. And then just lastly, very quickly, on SG-001, just great that you got the constructive feedback from FDA. So just in terms of timing, when you think you could file the IND and then start a clinical study? And I don't know if you want to just comment about the R&D spend as you go into that.

Adam Grossman

Sure. So really, really pleased. I mean, my team worked extremely hard and hats off to them for getting the pre-IND package in. Sometimes you plan and sometimes it works out for you. And we got feedback a short while ago and really pleased with the constructive engagement and feedback from the agency regarding clinical trial design, regarding how we're going to manufacture, regarding how we're going to test and release the product using an assay. And all of this bodes well for us from a full IND package preparation. I'm not prepared to give guidance on that yet, but you can imagine, and I think in the prepared remarks, I was pretty clear on manufacturing preparedness.

We've been collecting plasma. You see that step-up, and Terry can talk in more detail about the R&D in a second. But we've been collecting plasma, special plasma from immunized donors using Capvaxive and Prevnar. And we are moving this program forward. I mean, the feedback was extremely encouraging. And I do believe that there are some things that we ask for that will be quite novel. And in due course, we'll make that public. Again, the agency reserves the right to change their mind at any time. But we are going to work expeditiously to have an IND filed in a short time period as we possibly can, but I'm not prepared to give guidance yet on when that's going to be filed. But I would anticipate that sometime next year, we're updating the street and providing firm time lines around clinical trials, product development and regulatory time lines.

Do you want to talk about R&D spend, Terry?

P. Terence Kohler

Sure. Gary, we are not going to talk about for future R&D spend in 2027. But what I can tell you is that I mentioned before, we are going to be producing our performance lots here in Q4. So there is going to be a significant step-up in Q4 R&D versus what we had in Q3. So probably close to $10 million of spend in the quarter as we have additional plasma costs in manufacturing.

Adam Grossman

And just to clarify, Gary, the clinical trials that we've done in the past and that other companies have done for IG are registrational. And we believe that the trial that we will prepare and put together has the potential to be abbreviated and will be a registrational Phase III study.

Operator

Our next question comes from Kristen Kluska of Cantor Fitzgerald.

Kristen Kluska

I had two. The first question is now that you're seeing a lot of growth with ASCENIV in particular, including new patient adds. I'm curious if the mix of number of months patients are on drug is any different as we think about doing some of the back of the envelope math there?

Second question is -- good to see certain things are stabilizing, not out of the clear yet, but I know you guys typically give us guidance in early 2027. So do you think based on everything going on, that you'll be in a good position to share that or are there still dynamics that you still need to work out before you feel like you'll be able to provide those numbers?

Adam Grossman

Sure. Thanks, Kristen. You broke up a little bit on my line regarding the first question, but I think you were asking about how many months patients are staying on drug.

Kristen Kluska

Exactly.

Adam Grossman

Okay. Yes. I mean, patients are staying on drug. In the prepared remarks, I believe I used language where I said these are durable recurring patient demand, patient utilization. Patients are switching to ASCENIV therapy and they're staying on drug. Some data I've seen internally throughout the year, I mean, the average percent of patients is staying on therapy for a year or longer. And we're seeing this compounding, if you will, of utilization, and we're building off of that base. So what we really were trying to convey in the prepared remarks on this earnings call is that the business that we're building, we believe, is a durable base of business, and it's going to grow from that base in the subsequent months. So we're very encouraged by utilization.

Again, the real-world outcomes that have been published in multiple studies in different sites in different geographies, we're not seeing differentiation in the data. Reducing infections, reducing hospitalizations, reducing overall health care utilization, these are real benefits that have never before been seen with another IG product. And this is contributing to ASCENIV's durability and the growth trajectory of the product. So we're very, very pleased.

Operator

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

Adam Grossman

Thank you, everyone, for dialing into today's call. If there's no further questions, we appreciate it. Donate plasma. Please help us save a life. And thank you again to all ADMA Biologics employees for your hard work and for the investors for your investment into our company. That noise is not me, not sure who it is, but everybody, have a great day. Thank you.

Operator

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