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Adma Biologics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 2 narrowed, 3 kept. The quarter’s numbers.

Key takeaways

  • Total revenue rose five percent: Total revenue was $141.1 million, up 5% from $134.2 million a year earlier and up 13% from $124.4 million in the second quarter. Nine-month revenue was $380.0 million, up 2%. Source
  • GAAP net income and EPS rose: GAAP net income was $49.9 million, against $36.4 million a year earlier. GAAP basic EPS was $0.22, against $0.15, and diluted EPS was $0.22. Source
  • ASCENIV revenue rose 31%: ASCENIV revenue was $124.7 million, up 31% from $95.4 million a year earlier and up 21% from the second quarter. Management attributed growth to physician adoption, new patient starts and end-user utilization. Source
  • BIVIGAM revenue fell 35%: BIVIGAM revenue was $15.4 million, down from $23.8 million a year earlier and $19.4 million in the second quarter. Management attributed the sequential decline to competitive pricing and channel inventory pressure in the standard IG market. Source
  • Statistically significant reductions in outcomes: The analysis reported statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use after ASCENIV initiation. Source
  • Gross margin reached 71%: Gross profit was $99.9 million, a 71% gross margin, against 56% a year earlier and 69% in the second quarter. Management attributed the change to ASCENIV mix and yield-enhanced manufacturing. Source
  • Share repurchases reached 16.5 million shares: The company repurchased 2.7 million shares in the third quarter. Year-to-date repurchases through September 30 totaled 16.5 million shares, or 6.3% of shares outstanding at December 31, 2025. Source
  • FDA feedback on pre-IND package: The company reported FDA feedback on its SG-001 pre-IND meeting package, covering the proposed clinical development strategy and key elements of the planned study. Source

“Our third quarter results demonstrate ADMA’s ability to translate accelerating ASCENIV demand into substantial earnings growth”

Adam Grossman, President and Chief Executive Officer of ADMA

Guidance

AreaPeriodFigureAgainst last quarter
Total revenue SourceFY2026at least $530 millionKept
Adjusted Net Income SourceFY2026at least $180 millionNarrowed from $170 million to $200 million
Adjusted EBITDA SourceFY2026at least $275 millionNarrowed from $265 million to $300 million
Share repurchases Source2026$200 million or moreKept
SG-001 potential annual revenue SourceIf approved by FDA$300-500 millionKept

What changed from last quarter

  • Guidance raised: Minimum expectation for Adjusted Net Income increased, per management's statement. Source
  • Guidance raised: Minimum expectation for Adjusted EBITDA increased in the same statement. Source
  • Guidance kept: FY2026 total revenue guidance reiterated, stated as a minimum of $530 million in this release. Source
  • New: Company reports FDA feedback received on the SG-001 pre-IND meeting package. The prior release had only anticipated the pre-IND submission. Source

Quarter results and earnings

  • Total revenue rose five percent: Total revenue was $141.1 million, up 5% from $134.2 million a year earlier and up 13% from $124.4 million in the second quarter. Nine-month revenue was $380.0 million, up 2%. Source
  • GAAP net income and EPS rose: GAAP net income was $49.9 million, against $36.4 million a year earlier. GAAP basic EPS was $0.22, against $0.15, and diluted EPS was $0.22. Source
  • Adjusted measures rose year-over-year: Adjusted Net Income was $51.1 million against $38.9 million, Adjusted Basic EPS was $0.23 against $0.16, and Adjusted EBITDA was $77.3 million against $58.7 million. These are non-GAAP measures. Source
  • Nine-month earnings and EBITDA: Nine-month GAAP net income was $133.0 million, against $97.6 million. Nine-month Adjusted EBITDA was $198.8 million, against $157.4 million, a 26% increase. Source

Product sales by drug

  • ASCENIV revenue rose 31%: ASCENIV revenue was $124.7 million, up 31% from $95.4 million a year earlier and up 21% from the second quarter. Management attributed growth to physician adoption, new patient starts and end-user utilization. Source
  • ASCENIV demand trends continued into Q4: Management said pull-through trends for ASCENIV continued into the fourth quarter. Nine-month ASCENIV revenue was $325.1 million, up 27.5%. Source
  • BIVIGAM revenue fell 35%: BIVIGAM revenue was $15.4 million, down from $23.8 million a year earlier and $19.4 million in the second quarter. Management attributed the sequential decline to competitive pricing and channel inventory pressure in the standard IG market. Source
  • BIVIGAM utilization showed stabilization signs: Management described signs of stabilization in underlying end-user BIVIGAM utilization entering the fourth quarter. The company said it does not match competitor rebating and discounting. Source
  • Intermediates and plasma revenue declined: Intermediates and other products, which include NABI-HB, were $0.9 million against $15.0 million a year earlier. Plasma collection center revenue was $25 thousand. Source
  • ASCENIV indication age range updated: The product description now lists adults and pediatric patients aged 2 years and older. The prior release listed adults and children aged 2 to 17 years. Source

“We are reiterating our full-year revenue outlook while increasing our minimum expectations for Adjusted Net Income and Adjusted EBITDA and continue to advance SG-001 as a potential additional long-term growth opportunity.”

Adam Grossman, President and Chief Executive Officer of ADMA

Real-world outcomes evidence

  • 127-patient analysis planned for presentation: ADMA plans to present an analysis of 127 medically complex PI patients. Most had previously received other immune globulin therapies. Source
  • Statistically significant reductions in outcomes: The analysis reported statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use after ASCENIV initiation. Source
  • Study population and comparison period: Patients had PI plus respiratory comorbidities, substantial antimicrobial or corticosteroid use, or recurrent infection-related healthcare use. Outcomes compared the 12 months before and after ASCENIV initiation. Source

Margins, costs and expenses

  • Gross margin reached 71%: Gross profit was $99.9 million, a 71% gross margin, against 56% a year earlier and 69% in the second quarter. Management attributed the change to ASCENIV mix and yield-enhanced manufacturing. Source
  • R&D spend tied to SG-001 development: R&D expense was $4.5 million, against $1.5 million a year earlier and $6.0 million in the second quarter. The company linked the level to SG-001 development and lower plasma collection activity. Source
  • SG&A rose on personnel and legal fees: SG&A was $26.6 million, against $21.7 million a year earlier and $26.7 million in the second quarter. The year-over-year increase was attributed to personnel, professional fees and legal fees for ongoing litigation. Source
  • Non-GAAP add-backs described: Adjusted EBITDA excluded $6.2 million of stock-based compensation and $1.4 million of non-recurring professional fees in the quarter, per the reconciliation tables. Source

“We are also encouraged by signs of stabilization in underlying BIVIGAM utilization, despite competitive pressures in the standard immune globulin market.”

Adam Grossman, President and Chief Executive Officer of ADMA

Cash, balance sheet and capital returns

  • Nine-month operating cash flow rose: Net cash provided by operating activities was $105.2 million for the nine months, against $14.8 million a year earlier. Purchases of property and equipment were $6.8 million, against $21.5 million. Source
  • Cash balance rose in nine months: Cash and cash equivalents rose by $36.9 million in the nine months, to $124.6 million at September 30, 2026. Source
  • Long-term debt rose on revolver proceeds: Long-term debt was $191.6 million at September 30, 2026, against $69.3 million at December 31, 2025. The company recorded $125.0 million of JPM revolving facility proceeds in the nine months. Source
  • Share repurchases reached 16.5 million shares: The company repurchased 2.7 million shares in the third quarter. Year-to-date repurchases through September 30 totaled 16.5 million shares, or 6.3% of shares outstanding at December 31, 2025. Source
  • Treasury stock purchases in cash flow: Acquisition of treasury stock was $180.3 million in the nine-month cash flow statement, against $23.0 million a year earlier. Treasury shares held were 18,457,327 at September 30, 2026. Source
  • Inventories and receivables rose: Inventories rose to $266.1 million and accounts receivable to $169.2 million, from $206.5 million and $158.4 million at December 31, 2025. Source

SG-001 development and FDA feedback

  • FDA feedback on pre-IND package: The company reported FDA feedback on its SG-001 pre-IND meeting package, covering the proposed clinical development strategy and key elements of the planned study. Source
  • FDA said assay acceptable subject to validation: The FDA indicated the proposed assay would be acceptable for product testing, subject to appropriate validation. Source
  • ADMAlytics model used for titer forecasts: The company used its ADMAlytics platform, with computational modeling and artificial intelligence, to forecast final titer values from limited experimental data. Source
  • Immunocompromised patients face higher risk: Management said immunocompromised patients face elevated risk of severe pneumococcal disease and may receive limited protection from vaccination. Source

Coming up, as management said on 4 November 2026

  • ACAAI presentation in mid-November: The 127-patient real-world analysis is planned for presentation at the American College of Allergy, Asthma and Immunology annual conference in mid-November 2026. Source
  • IND preparation after FDA feedback: Management intends to incorporate the FDA recommendations into the final clinical protocol and advance preparations for an IND submission. No submission date was given. Source

Figures management reported

FigureReported
ASCENIV product revenue, third quarter Source$124.7 million (prior-year quarter $95.4 million)
ASCENIV product revenue, nine months Source$325.1 million
BIVIGAM product revenue, third quarter Source$15.4 million (prior-year quarter $23.8 million)
R&D expense, third quarter Source$4.5 million (prior-year quarter $1.5 million)
SG-001 pre-IND feedback SourceFDA feedback received on pre-IND meeting package

Risks management discussed

  • Demand: Management cited competitive conditions in the U.S. standard immune globulin market as an assumption in FY2026 guidance, and said the company does not match competitor rebating and discounting. Source
  • Regulatory: The FDA said the proposed SG-001 assay would be acceptable for product testing only subject to appropriate validation. Source
  • Regulatory: Legal fees rose on ongoing litigation and related matters, adding to SG&A in the quarter. Source

Earlier plans management reported on

  • On track: Management said the company continues to repurchase shares opportunistically and is on track to meet the target. Source
  • Not stated: The prior release expected the pre-IND package submission by year-end. This release reports FDA feedback received on the package; status is not stated.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.