ADMA on Nasdaq

ADMA Biologics (United States)

U.S. based end-to-end commercial biopharmaceutical company dedicated to1

In its 2026 annual report the company says: “We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters.”5 Its shares trade on Nasdaq under the symbol ADMA.1

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Last updated Oct 21, 2026.

Overview

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  • TickerADMA on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersRamsey1
  • Websitewww.admabiologics.com
  • Incorporated inDE3
  • Business addressC/O Adma Biologics, Inc., 465 State Route 17, Ramsey, Nj 074463
  • Filer categoryLarge accelerated filer3
ADMA Biologics (United States) image from its website
Image: admabiologics.com4

We are a U.S. based end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

57.4%Gross margin6
37.5%Operating margin6
28.8%Net margin6
19.6%Revenue growth, 20256
30.8%Return on equity6
0.15×Debt to equity6
$27.8MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Business segments

ADMABio Manufacturing brought in 97% of the revenue ADMA Biologics (United States) broke down this way in fiscal 2025.

  1. ADMABio Manufacturing$493.0M697%up 19% from 2024
  2. Plasma Collection Centers$17.0M63%up 62% from 2024
Business segments by year
Business segments202320242025
ADMABio Manufacturing$249.7M$415.8M$493.0M
Plasma Collection Centers$8.3M$10.5M$17.0M

Regions

United States brought in 99% of the revenue ADMA Biologics (United States) broke down this way in fiscal 2025.

  1. United States$504.1M699%up 23% from 2024
  2. Outside the United States$6.1M61%down 63% from 2024
Regions by year
Regions202320242025
United States$244.9M$410.1M$504.1M
Outside the United States$13.3M$16.3M$6.1M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue43¢$217.4M
  • Research and development1¢$4.8M
  • Selling, general and admin18¢$91.6M
  • Other costs3¢$13.8M
  • Income tax7¢$35.7M
  • Profit29¢$146.9M

Out of $510.2M in revenue.6

Where each dollar of operating cash went, fiscal 2025

  • Capital spending41¢$22.6M
  • Share buybacks59¢$31.9M

Out of $50.4M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.6

Financial statements

Revenue789106$510.2M in 2025+1638% since 2019
0$200.0M$400.0M$600.0M2019: $29.3M$29.3M20192020: $42.2M$42.2M2020+44%2021: $80.9M$80.9M2021+92%2022: $154.1M$154.1M2022+90%2023: $258.2M$258.2M2023+68%2024: $426.5M$426.5M2024+65%2025: $510.2M$510.2M2025+20%
Gross profit89106$292.8M in 2025
-$100.0M0$100.0M$200.0M$300.0M2020: -$19.1M-$19.1M20202021: $1.2M$1.2M20212022: $35.3M$35.3M2022+2906%2023: $88.9M$88.9M2023+152%2024: $219.6M$219.6M2024+147%2025: $292.8M$292.8M2025+33%
Operating income789106$191.4M in 2025
-$100.0M0$100.0M$200.0M2019: -$41.4M-$41.4M20192020: -$64.9M-$64.9M2020+57%2021: -$58.4M-$58.4M2021−10%2022: -$39.4M-$39.4M2022−33%2023: $21.6M$21.6M20232024: $139.0M$139.0M2024+542%2025: $191.4M$191.4M2025+38%
Net income789106$146.9M in 2025
-$100.0M0$100.0M$200.0M2019: -$48.3M-$48.3M20192020: -$75.7M-$75.7M2020+57%2021: -$71.6M-$71.6M2021−5%2022: -$65.9M-$65.9M2022−8%2023: -$28.2M-$28.2M2023−57%2024: $197.7M$197.7M20242025: $146.9M$146.9M2025−26%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
REVENUES$510.2M$426.5M$258.2M
Cost of product revenue$217.4M$206.9M$169.3M
Gross profit$292.8M$219.6M$88.9M
Research and development$4.8M$1.8M$3.3M
Plasma center operating expenses$4.8M$4.2M$4.3M
Amortization of intangible assets$144.0K$388.0K$724.0K
Selling, general and administrative$91.6M$74.1M$59.0M
Total operating expenses$101.3M$80.6M$67.3M
INCOME FROM OPERATIONS$191.4M$139.0M$21.6M
Interest income$1.9M$2.1M$1.6M
Interest expense-$7.1M-$13.9M-$25.0M
Loss on extinguishment of debt-$3.3M-$1.2M-$26.2M
Other expense-$212.0K-$193.0K-$287.0K
Other expense, net-$8.8M-$13.3M-$49.9M
INCOME (LOSS) BEFORE INCOME TAXES$182.7M$125.7M-$28.2M
Income tax expense (benefit)$35.7M-$72.0M$0
NET INCOME (LOSS)$146.9M$197.7M-$28.2M
BASIC EARNINGS (LOSS) PER COMMON SHARE (in Dollars per share)$0.62$0.85-$0.13
DILUTED EARNINGS (LOSS) PER COMMON SHARE (in Dollars per share)$0.60$0.81-$0.13
Basic (in Shares)238.3M shares233.1M shares224.0M shares
Diluted (in Shares)244.9M shares243.3M shares224.0M shares

Compare ADMA Biologics (United States) with another company

Corporate structure

ADMA Biologics (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ADMA Biologics (United States)

  • State Street Corporation Filed SCHEDULE 13G on ADMA Biologics (United States), latest Aug 7, 2026 (4 filings since Oct 17, 2024)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on ADMA Biologics (United States), latest Apr 29, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on ADMA Biologics (United States), latest Mar 26, 2026 (5 filings since Feb 13, 2024)
  • Invesco Filed SCHEDULE 13G/A on ADMA Biologics (United States), latest Feb 12, 2026 (4 filings since Nov 8, 2024)
  • BlackRock Filed SCHEDULE 13G/A on ADMA Biologics (United States), latest Apr 30, 2025 (4 filings since Feb 3, 2023)
  • MILLENNIUM MANAGEMENT LLC Filed SC 13G on ADMA Biologics (United States), latest Sep 23, 2024 (2 filings since Jun 28, 2022)
  • Nuveen Asset Management, LLC Filed SC 13G/A on ADMA Biologics (United States), latest Mar 11, 2024 (3 filings since Feb 14, 2023)
  • TEACHERS ADVISORS, LLC Filed SC 13G/A on ADMA Biologics (United States), latest Mar 11, 2024 (3 filings since Feb 14, 2023)
  • TIAA CREF INVESTMENT MANAGEMENT LLC Filed SC 13G/A on ADMA Biologics (United States), latest Mar 11, 2024 (3 filings since Feb 14, 2023)
  • PERCEPTIVE ADVISORS LLC Filed SC 13G/A on ADMA Biologics (United States), latest Feb 14, 2024 (4 filings since Oct 27, 2021)
  • Stonepine Capital Management, LLC Filed SC 13G/A on ADMA Biologics (United States), latest Feb 13, 2023 (3 filings since Dec 30, 2021)
  • Caligan Partners LP Filed SC 13D/A on ADMA Biologics (United States), latest Dec 9, 2022 (2 filings since Feb 4, 2022)
  • ADMA Biologics (United States) Ramsey

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What ADMA Biologics (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$103.4M6 Dec 31, 2025$88.3M6 Dec 31, 2024+17.2%
Accumulated depreciation$38.3M6 Dec 31, 2025$33.6M6 Dec 31, 2024+14.3%
Property and equipment, net$65.1M6 Dec 31, 2025$54.7M6 Dec 31, 2024+18.9%
Operating-lease assets (leased space)$6.7M6 Dec 31, 2025$8.6M6 Dec 31, 2024−23.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$87.6M6 Dec 31, 2025$103.1M6 Dec 31, 2024−15.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$3.5M6 Dec 31, 2025$3.5M6 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$632.0K6 Dec 31, 2025$460.0K6 Dec 31, 2024+37.4%
Finite-lived intangibles, gross$5.6M10 Dec 31, 2024$5.2M10 Dec 31, 2023+6.7%
Accumulated amortization$5.1M10 Dec 31, 2024$4.7M10 Dec 31, 2023+8.2%
Finite-lived intangibles, net$460.0K10 Dec 31, 2024$499.0K10 Dec 31, 2023−7.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$206.5M6 Dec 31, 2025$170.2M6 Dec 31, 2024+21.3%
Raw materials$96.6M6 Dec 31, 2025$60.5M6 Dec 31, 2024+59.8%
Work in process$57.8M6 Dec 31, 2025$61.6M6 Dec 31, 2024−6.2%
Finished goods$52.1M6 Dec 31, 2025$48.1M6 Dec 31, 2024+8.2%

Properties, in its own words

Properties

The table below describes our principal facilities as of December 31, 2025:

The rest of Item 2

Location · Principal Business Activity · Approximate Square Feet · Owned or expiration date of lease

Ramsey, NJ · Corporate Headquarters · 4,200 · December 31, 2026*

Boca Raton, FL · Manufacturing and Administration · 84,462 · Owned

Boca Raton, FL · Laboratory and Administration · 44,495 · Owned

Boca Raton, FL · Warehousing and Administration · 38,195 · Owned

*Pursuant to a shared services agreement, as amended, with Areth, LLC ("Areth") for office, warehouse space and related services pursuant to which the Company pays Areth monthly lease payments of $10,000. Areth is a company controlled by Dr. Jerrold B. Grossman, our Vice Chairman of the Board of Directors, and Adam S. Grossman, our President and Chief Executive Officer.

As of December 31, 2025, we maintained ten plasma collection centers in leased facilities mainly in the southeastern part of the U.S., which require lease payments through the respective lease terms that expire at various dates through 2033 (see Notes 5 and 12 to the consolidated financial statements appearing elsewhere in this report).

We believe that our leased and owned properties are adequate to meet our current and future needs.

Item 2 of the 10-K filed Feb 25, 2026.5

Leadership

Who has led ADMA Biologics (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (16)

Former names

  • R&R ACQUISITION VI, INCJul 10, 2006 to Feb 21, 20123

Timeline

  1. Aug 5, 20268-K Results of operations35
  2. Jun 2, 20268-K Shareholder vote36
  3. May 6, 20268-K Results of operations37
  4. May 4, 20268-K Other events38
  5. Mar 27, 20268-K Regulation FD disclosure39
  6. Mar 2, 20268-K Regulation FD disclosure; Other events40
  7. Feb 25, 20268-K Results of operations; Executive or director change41
  8. Jan 12, 20268-K Results of operations; Regulation FD disclosure42
  9. Nov 5, 20258-K Results of operations43
  10. Aug 6, 20258-K Entered a material agreement; Ended a material agreement; Results of operations44
  11. Jun 4, 20258-K Shareholder vote45
  12. May 7, 20258-K Results of operations; Other events46

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.16 a share, on Nov 5, 2025.47

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results35
  2. May 6, 2026Reported quarterly or annual results37
  3. Feb 25, 2026Reported quarterly or annual results41
  4. Jan 12, 2026Reported quarterly or annual results42
  5. Nov 5, 2025Reported quarterly or annual results43
  6. Aug 6, 2025Reported quarterly or annual results44
  7. May 7, 2025Reported quarterly or annual results46
  8. Mar 3, 2025Reported quarterly or annual results48

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

347 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 80 major events, 146 insider forms, 40 large holders, 61 other. The latest 20:

  1. Aug 7, 2026SCHEDULE 13G EDGAR
  2. Aug 5, 202610-Q EDGAR
  3. Aug 5, 20268-K EDGAR
  4. Jul 28, 20264 EDGAR
  5. Jul 17, 20264 EDGAR
  6. Jun 2, 20268-K EDGAR
  7. May 28, 20264 EDGAR
  8. May 14, 20264 EDGAR
  9. May 12, 20264 EDGAR
  10. May 6, 202610-Q EDGAR
  11. May 6, 20268-K EDGAR
  12. May 4, 20268-K EDGAR
  13. Apr 29, 2026SCHEDULE 13G EDGAR
  14. Apr 15, 2026ARS EDGAR
  15. Apr 15, 2026DEFA14A EDGAR
  16. Apr 15, 2026DEF 14A EDGAR
  17. Apr 3, 20264 EDGAR
  18. Mar 27, 20268-K EDGAR
  19. Mar 26, 2026SCHEDULE 13G/A EDGAR
  20. Mar 17, 20264 EDGAR

The 347 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

53 open-market trades by officers, directors and large owners since October 2021: 13 buys and 40 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 27, 2026Grossman Jerrold BDirectorBuy6,400$7.91$50.6KForm 4
May 12, 2026Grossman Jerrold BDirectorBuy12,500$8.01$100.1KForm 4
May 11, 2026Grossman Jerrold BDirectorBuy12,500$8.01$100.1KForm 4
Mar 16, 2026Grossman Adam SPresident and CEOSale21,000$15.16$318.4KForm 4
Mar 9, 2026Kestenberg-Messina Kaitlin M.COO and SVP, ComplianceSale10,096$15.63$157.8KForm 4
Mar 6, 2026ELMS STEVEDirectorBuy7,000$15.39$107.7KForm 4
Mar 5, 2026ELMS STEVEDirectorBuy7,000$15.67$109.7KForm 4
Feb 17, 2026Grossman Adam SPresident and CEOSale21,000$16.08$337.7KForm 4
Dec 15, 2025Grossman Adam SPresident and CEOSale21,000$19.79$415.6KForm 4
Nov 19, 2025Grossman Adam SPresident and CEOSale21,000$16.00$336.0KForm 4
Oct 24, 2025Grossman Adam SPresident and CEOSale21,000$16.00$336.0KForm 4
Sep 15, 2025Grossman Adam SPresident and CEOSale21,000$16.13$338.7KForm 4
Aug 15, 2025Grossman Adam SPresident and CEOSale21,000$16.88$354.5KForm 4
Jul 15, 2025Grossman Adam SPresident and CEOSale21,000$18.66$391.9KForm 4
Jun 16, 2025Grossman Adam SPresident and CEOSale21,000$20.81$437.0KForm 4
Jun 16, 2025ELMS STEVEDirectorSale194,749$20.24$3.9MForm 4
Jun 13, 2025ELMS STEVEDirectorSale137,931$20.82$2.9MForm 4
Jun 12, 2025ELMS STEVEDirectorSale92,941$21.69$2.0MForm 4
Jun 9, 2025Guiheen Lawrence P.DirectorSale20,000$20.96$419.2KForm 4
Jun 9, 2025Grossman Jerrold BDirectorSale10,000$21.31$213.1KForm 4

All 53 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Adam S. Grossman$925.0K$10.2M63
2025Kaitlin Kestenberg$575.0K$3.5M63
2025Brad L. Tade$500.0K$2.8M63
2025Paul Terence KohlerJr.$19.2K$2.3M63
2024PresidentChief Executive Officer and Director$800.0K$7.9M63
2024Chief Operating Officer & Senior Vice PresidentCompliance$433.1K$3.3M63
2024Former Executive VicePresident and Chief Financial Officer$374.8K$2.9M63
2023PresidentChief Executive Officer and Director$750.0K$6.0M63

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.38,355,684$321.0M0.0%+1,524,910
State Street Corp17,116,022$143.3M0.0%+3,031,817
Vanguard Capital Management LLC10,103,809$84.6M0.0%−203,062
Vanguard Portfolio Management LLC10,088,490$84.4M0.0%+1,219,833
Rubric Capital Management LP9,339,414$78.2M0.7%+7,530,006
Capital Research Global Investors8,756,374$73.3M0.0%−2,434,742
First Trust Advisors LP7,798,351$65.3M0.0%+7,438,134
Geode Capital Management, LLC6,059,984$50.7M0.0%+235,868
Caligan Partners LP5,725,007$47.9M2.3%+968,496
D. E. Shaw & Co., Inc.5,274,597$44.1M0.0%+4,713,770
Nantahala Capital Management, LLC4,719,986$39.5M1.2%New
Dimensional Fund Advisors LP3,606,208$30.2M0.0%−1,399,273
Goldman Sachs Group Inc3,513,583$29.4M0.0%+710,053
B Group, Inc.3,262,542$27.3M15.5%+55,000
Nuveen, LLC3,260,349$27.3M0.0%−2,837,876
Northern Trust Corp2,415,971$20.2M0.0%+138,659
Morgan Stanley2,265,443$19.0M0.0%−168,936
Ranger Investment Management, L.P.2,115,417$17.7M1.1%−168,393
Charles Schwab Investment Management Inc2,092,594$17.5M0.0%−3,178
Two Sigma Investments, LP2,019,887$16.9M0.0%−72,246
Kennedy Capital Management LLC1,755,152$14.7M0.3%+1,343,805
Vanguard Fiduciary Trust Co1,654,613$13.8M0.0%+17,054
Fundsmith LLP1,649,493$13.8M0.1%No change
Bank Of America Corp /de/1,647,647$13.8M0.0%−2,350,028
Aqr Capital Management LLC1,525,581$12.8M0.0%+1,010,792

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How ADMA Biologics (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARADMA BIOLOGICS, INC.2
  • CIK0001368514
  • Employer ID (EIN)56-25904425
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business addressC/O Adma Biologics, Inc., 465 State Route 17, Ramsey, NJ 074462
  • Phone(201) 478-55522
  • Shares outstanding223,984,680 as of Jul 31, 202612
  • Public float$4.2B as of Jun 30, 20255
  • AuditorKPMG LLP, Stamford, Connecticut PCAOB ID 185; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceJul 10, 20062
  • Filings995 in all: 4 (329), 8-K (266), 10-Q (55), SC 13G/A (33), CORRESP (29), 3 (25), 144 (21), SC 13G (19)2
    All 49 form types

    424B5 (18), 10-K (17), UPLOAD (16), DEF 14A (14), S-1/A (13), CT ORDER (12), SC 13D/A (12), DEFA14A (10), S-8 (9), SC 13D (9), EFFECT (8), 4/A (7), S-8 POS (7), 10QSB (6), 8-K/A (5), ARS (5), S-3 (5), SCHEDULE 13G (5), SCHEDULE 13G/A (5), PRE 14A (4), 8-A12B (3), S-1 (3), S-3/A (3), 10KSB (2), 15-12B (2), D (2), SEC STAFF LETTER (2), 10-K/A (1), 10SB12G (1), 144/A (1), 424B1 (1), 424B3 (1), 424B4 (1), 424B7 (1), CERTNAS (1), DEF 14C (1), DEFM14A (1), DEFR14A (1), NT 10-K (1), PREM14A (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 15, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareADMANasdaq

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks ADMA Biologics (United States) names in Item 1A of its 10-K filed Feb 25, 2026: 57 risks under these headings, as written.5

  • Risks Relating to our Business
  • Although we achieved net income on a GAAP basis for the years ended December 31, 2024 and 2025, we may not be able to maintain profitability and continue to generate positive cash flows in the future.
  • Our business may be adversely affected by a pandemic, epidemic, or outbreak of an unknown or emerging infections disease.
  • We contract with third parties for a portion of the filling, packaging, testing and labeling of the drug substance we manufacture, and also obtain plasma from certain third parties. This reliance on third parties carries the risk that the services and raw materials upon which we rely may not be performed in a timely manner, in sufficient quantities or according to our specifications, which could delay the availability of our finished drug product and could adversely affect our commercialization efforts and our revenues.
  • The estimates of market opportunity and forecasts of market and revenue growth included in our filings may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.
  • Geopolitical and economic conditions, war, terrorism or other military actions may have a material adverse effect on our business.
  • Both of our business segments and our facilities, as well as our suppliers and contractors, are subject to periodic inspections by the FDA and other regulatory authorities, which, depending on the outcome of such inspections, could result in certain regulatory actions, including the issuance of observations, notices, citations, warning letters or other enforcement actions.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Business interruptions could adversely affect our business.
  • If we are unsuccessful in obtaining regulatory approval for any of our product candidates or if any of our product candidates do not provide positive results, we may be required to delay or abandon development of such product, which would have a material adverse impact on our business.
  • If the results of our clinical trials do not support our product candidate claims, completing the development of such product candidate may be significantly delayed or we may be forced to abandon development of such product candidate altogether.
  • If we do not obtain and maintain the necessary U.S. or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make it difficult for us to recover the costs of researching and developing such product candidate.
The other 46 risks
  • Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, our ability to market or seek approval for ASCENIV for alternative indications could be limited, unless additional clinical trials are conducted successfully and the FDA approves a BLA or other required submission for review.
  • With the approval of ASCENIV, there can be no assurance that we will be successful in further developing and expanding commercial operations, collecting and procuring an adequate supply of high-titer antibody RSV plasma or balancing our research and development activities with our commercialization activities.
  • We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our products and product candidates, as well as for other pre and post-approval services, and such parties’ performance is, to some extent, outside of our control.
  • We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA.
  • Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions or withdrawal from the market and we could be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.
  • Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on our business, results of operations and financial condition.
  • Issues with product quality and compliance could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.
  • If physicians, payers and patients do not accept and use our current products or our future product candidates, our ability to generate revenue from these products will be materially impaired.
  • Our accruals for U.S. Medicaid rebates and other liabilities related to the sale of our immunoglobulin products are estimates based on historical experience and other assumptions. These estimates are subject to change based on actual results and other factors. Any such change could have a material effect on our business, financial position, and operating results.
  • Our long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product candidates and label expansion of existing products, and if our business development efforts are not successful, our ability to maintain profitability may be adversely impacted.
  • Our ADMA BioCenters operations collect information from donors in the United States that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail to meet their requirements.
  • The JPMorgan Credit Facilities are subject to acceleration in specified circumstances, which may result in JPMorgan taking possession and disposing of any collateral.
  • Developments by competitors may render our products or technologies obsolete or non-competitive.
  • If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged.
  • We could lose market exclusivity of a product earlier than expected.
  • Third parties could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable terms or at all.
  • If we are unable to successfully manage our growth, our business may be harmed.
  • The loss of one or more key members of our management team could adversely affect our business.
  • Cyberattacks and other security breaches could compromise our proprietary and confidential information or otherwise penetrate our network, which could harm our business and reputation.
  • Issues in the development and use of AI may result in reputational harm and increased liability exposure.
  • If we are unable to hire and retain a substantial number of qualified personnel, our ability to sustain and grow our business may be harmed.
  • We currently collect human blood plasma at our ADMA BioCenters facilities, and if we cannot maintain FDA licensure for these facilities or obtain FDA licensure for additional facilities that we may construct or acquire rights to, we may be adversely affected and may not be able to sell or use this human blood plasma for future commercial purposes.
  • We manufacture our current marketed products, pipeline products, and products for third parties in our manufacturing and testing facilities, and if we or our vendors cannot maintain appropriate FDA status for these facilities, we may be adversely affected, and may not be able to sell, manufacture or commercialize these products.
  • We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.
  • Many of our business practices are subject to scrutiny by federal and state regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws. Failure to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us.
  • We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatory approvals before our products and product candidates may be lawfully marketed, and our ability to obtain regulatory approval of our products and product candidates from the FDA in a timely manner, access the public markets and obtain necessary capital in order to properly capitalize and continue our operations may be hindered by inadequate funding for the FDA, the SEC and other state and local government agencies.
  • There may be and have been changes in legal and regulatory requirements that may materially impact our results of operation.
  • The manufacturing processes for plasma-based biologics are complex and involve biological intermediates that are susceptible to contamination and impurities.
  • Our ability to continue to produce safe and effective products depends on the safety of our plasma supply, testing by third parties and the timing of receiving the testing results, and manufacturing processes we have in place to counter transmittable diseases.
  • We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source and high-titer plasma with proper specifications or other necessary raw materials.
  • Our ability to commercialize our products, alone or with collaborators, will depend in part upon the extent to which reimbursement will be available from governmental agencies, health administration authorities, private health maintenance organizations and health insurers and other healthcare payers, and also depends upon the approval, timing and representations by the FDA or other governmental authorities for our product candidates.
  • The biosimilar pathway established as part of healthcare reform may make it easier for competitors to market biosimilar products.
  • The implementation of the Healthcare Reform Law in the United States may adversely affect our business.
  • Corporate responsibility, specifically related to Environmental, Social and Governance (“ESG”) matters, may impose additional costs and expose us to new risks.
  • Risks Relating to our Finances, Capital Requirements and Other Financial Matters
  • We may not have cash available to us in amounts sufficient to enable us to make interest or principal payments on our indebtedness when due.
  • Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
  • Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.
  • If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could result in investors losing confidence in the accuracy and completeness of our financial statements, harm our operating results and negatively affect the market price of our common stock.
  • Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.
  • Fluctuations in our tax obligations and effective tax rate and realization of our net deferred tax assets may result in volatility of our operating results and materially impact our financial condition or financial results.
  • Risks Associated with our Common Stock
  • The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
  • Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely affect the market price of our common stock.
  • Our affiliates control a substantial amount of our shares of common stock. Provisions in our Second Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), our Amended and Restated Bylaws (the “Bylaws”) and Delaware law might discourage, delay or prevent a change in control of our Company or changes in our management and, therefore, depress the trading price of our common stock.
  • We have never paid cash dividends and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain.
  • If we fail to adhere to the strict listing requirements of the Nasdaq Global Market (“Nasdaq”), we may be subject to delisting. As a result, our stock price may decline and our common stock may be delisted. If our stock were no longer listed on Nasdaq, the liquidity of our securities likely would be impaired.
  • Our Board may, without stockholder approval, issue and fix the terms of shares of preferred stock and issue additional shares of common stock adversely affecting the rights of holders of our common stock.

Legal proceedings

Legal Proceedings

We are and may become subject to certain legal proceedings and claims arising in connection with the normal course of our business. Neither the Company nor any of its subsidiaries are a party to any material pending legal proceedings, other than ordinary routine litigation incidental to our business.

The opening of Item 3, Legal Proceedings.5

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