UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)


QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2021
OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission file number 001-36728
ADMA BIOLOGICS, INC.
(Exact Name of Registrant as Specified in Its Charter)

Delaware
 
56-2590442
(State or Other Jurisdiction of Incorporation or Organization)
 
(I.R.S. Employer Identification No.)

465 State Route 17, Ramsey, New Jersey
 
07446
(Address of Principal Executive Offices)
 
(Zip Code)

(201) 478-5552
(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock
ADMA
Nasdaq Global Market
Preferred Share Purchase Right
-
Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes ☒    No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes ☒    No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 
Large accelerated filer    ☐
Accelerated filer    ☐
 
Non-accelerated filer   
Smaller reporting company   
   
Emerging growth company   

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes     No ☒

As of August 6, 2021, there were 132,769,471 shares of the issuer’s common stock outstanding.



ADMA BIOLOGICS, INC. AND SUBSIDIARIES

INDEX

 
   
 
Item 1.
1
       
   
1
       
   
2
       
   
3
       
   
4
       
   
5
       
 
Item 2.
23
       
 
Item 3.
37
       
 
Item 4.
37
       
38
   
 
Item 1.
38
       
 
Item 1A.
38
       
 
Item 2.
68
       
 
Item 3.
68
       
 
Item 4.
68
       
 
Item 5.
68
       
 
Item 6.
68
       
69

This Quarterly Report on Form 10-Q includes our trademarks, trade names and service marks, such as “ASCENIV,” “Nabi-HB®” and “BIVIGAM®,” which are protected under applicable intellectual property laws and are the property of ADMA Biologics, Inc., or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this report may appear without the ®, or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
 
Special Note Regarding Forward-Looking Statements

Some of the information in this Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These statements include, among others, statements about: 


our ability to continue as a going concern;


our ability to manufacture BIVIGAM and ASCENIV on a commercial scale and commercialize these products as a result of their approval by the U.S. Food and Drug Administration (the “FDA”) in 2019;


our plans to develop, manufacture, market, launch and expand our commercial infrastructure and commercialize our current and future products and the success of such efforts;


the safety, efficacy and expected timing of and our ability to obtain and maintain regulatory approvals for our current products and product candidates, and the labeling or nature of any such approvals;


the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates;


our dependence upon our third-party customers and vendors and their compliance with applicable regulatory requirements;


our belief that we have addressed the delays experienced with final drug product Good Manufacturing Practices (“GMP”) release testing by our third-party vendors by adding additional release testing laboratories to our FDA-approved consortium listed in our drug approval documents;


our ability to obtain adequate quantities of FDA-approved plasma with proper specifications;


our plans to increase our supplies of source plasma, which include plasma collection center expansion and reliance on third-party supply agreements as well as any extensions to such agreements;


the potential indications for our products and product candidates;


potential investigational new product applications;


the acceptability of any of our products, including BIVIGAM, ASCENIV and Nabi-HB, for any purpose, including FDA-approved indications, by physicians, patients or payers;


our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses;


Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions;


concurrence by the FDA with our conclusions concerning our products and product candidates;


the comparability of results of our hyperimmune and immune globulin products to other comparably run hyperimmune and immune globulin clinical trials;


the potential for ASCENIV and BIVIGAM to provide meaningful clinical improvement for patients living with Primary Immune Deficiency Disease, Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”)   or other immune deficiencies or any other condition for which the products may be prescribed or evaluated;

ii


our ability to market and promote Nabi-HB in a highly competitive environment with increasing competition from other antiviral therapies and to generate meaningful revenues from this product;


our intellectual property position and the defense thereof, including our expectations regarding the scope of patent protection with respect to ASCENIV or other future pipeline product candidates;


our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy;


our plans related to the expansion of our manufacturing capacity, yield improvements, supply-chain robustness, in-house fill-finish capabilities, distribution and other collaborative agreements and the success of such endeavors;


our estimates regarding revenues, expenses, capital requirements, timing to profitability and the need for and availability of additional financing;


possible or likely reimbursement levels for our currently marketed products;


estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM;


effects of the coronavirus COVID-19 pandemic on our business, financial condition, liquidity and results of operations, and our ability to continue operations in the same manner as previously conducted prior to the macroeconomic effects of the COVID-19 pandemic;


future domestic and global economic conditions or performance; and


expectations for future capital requirements.
 
These statements may be found under the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this Quarterly Report on Form 10-Q. Forward-looking statements  may be identified by the use of terms such as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” or “should” or the negative thereof or other variations thereof or comparable terminology. Our actual results could differ materially from those contained in the forward-looking statements due to the factors described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statement included or incorporated by reference in this Quarterly Report on Form 10-Q reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions related to our operations, industry and future growth. These forward-looking statements speak only as of the dates such statements are made and we undertake no obligation to publicly update any forward-looking statements or to publicly announce revisions to any of the forward-looking statements, unless otherwise required by the federal securities laws.
 
iii

PART I
FINANCIAL INFORMATION
Item 1.
Financial Statements.
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

   
June 30,
2021
   
December 31,
2020
 
   
(Unaudited)
       
ASSETS
           
Current assets:
           
Cash and cash equivalents
 
$
42,408,958
   
$
55,921,152
 
Accounts receivable, net
   
23,544,594
     
13,237,290
 
Inventories
   
99,699,743
     
81,535,599
 
Prepaid expenses and other current assets
   
5,701,863
     
3,046,466
 
Total current assets
   
171,355,158
     
153,740,507
 
Property and equipment, net
   
46,486,980
     
41,593,090
 
Intangible assets, net
   
2,086,445
     
2,444,121
 
Goodwill
   
3,529,509
     
3,529,509
 
Right to use assets
   
6,829,040
     
4,259,191
 
Deposits and other assets
   
2,526,660
     
2,106,976
 
TOTAL ASSETS
 
$
232,813,792
   
$
207,673,394
 
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
 
$
6,167,465
   
$
11,073,708
 
Accrued expenses and other current liabilities
   
11,490,239
     
8,365,143
 
Current portion of deferred revenue
   
142,834
     
142,834
 
Current portion of lease obligations
   
385,858
     
365,682
 
Total current liabilities
   
18,186,396
     
19,947,367
 
Senior notes payable, net of discount
   
93,877,017
     
92,968,866
 
Deferred revenue, net of current portion
   
2,047,281
     
2,118,698
 
Lease obligations, net of current portion
   
7,073,415
     
4,334,151
 
Other non-current liabilities
   
36,151
     
54,886
 
TOTAL LIABILITIES
   
121,220,260
     
119,423,968
 
                 
COMMITMENTS AND CONTINGENCIES
           
                 
STOCKHOLDERS’ EQUITY
               
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding
   
-
     
-
 
Common Stock - voting, $0.0001 par value, 300,000,000 and 150,000,000 shares authorized, 131,872,026 and 104,902,888 shares issued and outstanding
   
13,187
     
10,490
 
Additional paid-in capital
   
489,330,692
     
428,704,039
 
Accumulated deficit
   
(377,750,347
)
   
(340,465,103
)
TOTAL STOCKHOLDERS’ EQUITY
   
111,593,532
     
88,249,426
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
 
$
232,813,792
   
$
207,673,394
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
                         
REVENUES:
                       
Product revenue
 
$
17,794,881
   
$
7,751,885
   
$
33,807,791
   
$
17,915,921
 
License revenue
   
35,709
     
35,709
     
71,417
     
71,417
 
Total revenues
   
17,830,590
     
7,787,594
     
33,879,208
     
17,987,338
 
                                 
OPERATING EXPENSES:
                               
Cost of product revenue (exclusive of amortization expense shown below)
   
18,832,624
     
13,495,629
     
36,602,746
     
30,324,855
 
Research and development
   
1,158,866
     
1,656,420
     
2,146,515
     
3,185,158
 
Plasma center operating expenses
   
2,803,326
     
877,902
     
5,045,669
     
1,378,546
 
Amortization of intangible assets
   
178,838
     
178,838
     
357,676
     
357,676
 
Selling, general and administrative
   
10,438,168
     
8,702,630
     
20,472,083
     
16,634,714
 
Total operating expenses
   
33,411,822
     
24,911,419
     
64,624,689
     
51,880,949
 
                                 
LOSS FROM OPERATIONS
   
(15,581,232
)
   
(17,123,825
)
   
(30,745,481
)
   
(33,893,611
)
                                 
OTHER INCOME (EXPENSE):
                               
Interest income
   
5,926
     
19,411
     
27,985
     
267,479
 
Interest expense
   
(3,246,680
)
   
(3,067,306
)
   
(6,442,430
)
   
(5,784,397
)
Other expense
   
(83,317
)
   
(6,371
)
   
(125,318
)
   
(12,792
)
Other expense, net
   
(3,324,071
)
   
(3,054,266
)
   
(6,539,763
)
   
(5,529,710
)
                                 
NET LOSS
 
$
(18,905,303
)
 
$
(20,178,091
)
 
$
(37,285,244
)
 
$
(39,423,321
)
                                 
BASIC AND DILUTED LOSS PER COMMON SHARE
 
$
(0.15
)
 
$
(0.23
)
 
$
(0.31
)
 
$
(0.49
)
                                 
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
                               
Basic and Diluted
   
127,416,126
     
86,347,467
     
121,571,501
     
80,064,641
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(Unaudited)

For the Three and Six Months Ended June 30, 2021

   
Common Stock
   
Additional
Paid-in
   
Accumulated
   
Total
Stockholders’
 
   
Shares
   
Amount
   
Capital
   
Deficit
   
Equity
 
Balance at December 31, 2020
   
104,902,888
   
$
10,490
   
$
428,704,039
   
$
(340,465,103
)
 
$
88,249,426
 
Stock-based compensation
   
-
     
-
     
781,397
     
-
     
781,397
 
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
   
61,385
     
6
     
(59,317
)
   
-
     
(59,311
)
Issuance of common stock, net of offering expenses
   
18,080,708
     
1,808
     
41,910,707
     
-
     
41,912,515
 
Net loss
   
-
     
-
     
-
     
(18,379,941
)
   
(18,379,941
)
Balance at March 31, 2021
   
123,044,981
     
12,304
     
471,336,826
     
(358,845,044
)
   
112,504,086
 
Stock-based compensation
   
-
     
-
     
805,189
     
-
     
805,189
 
Issuance of common stock, net of offering expenses
   
8,827,045
     
883
     
17,188,677
     
-
     
17,189,560
 
Net loss
   
-
     
-
     
-
     
(18,905,303
)
   
(18,905,303
)
Balance at June 30, 2021
   
131,872,026
   
$
13,187
   
$
489,330,692
   
$
(377,750,347
)
 
$
111,593,532
 

For the Three and Six Months Ended June 30, 2020

   
Common Stock
   
Additional
Paid-in
   
Accumulated
   
Total
Stockholders’
 
   
Shares
   
Amount
   
Capital
   
Deficit
   
Equity
 
Balance at December 31, 2019
   
59,318,355
   
$
5,932
   
$
290,903,772
   
$
(264,716,555
)
 
$
26,193,149
 
Stock-based compensation
   
-
     
-
     
676,548
     
-
     
676,548
 
Issuance of common stock, net of offering expenses
   
27,025,000
     
2,703
     
88,701,336
     
-
     
88,704,039
 
Exercise of stock options
   
1,958
     
-
     
7,177
     
-
     
7,177
 
Net loss
   
-
     
-
     
-
     
(19,245,230
)
   
(19,245,230
)
Balance at March 31, 2020
   
86,345,313
     
8,635
     
380,288,833
     
(283,961,785
)
   
96,335,683
 
Stock-based compensation
   
-
     
-
     
715,608
     
-
     
715,608
 
Exercise of stock options
   
4,668
     
-
     
6,255
     
-
     
6,255
 
Net loss
   
-
     
-
     
-
     
(20,178,091
)
   
(20,178,091
)
Balance at June 30, 2020
   
86,349,981
   
$
8,635
   
$
381,010,696
   
$
(304,139,876
)
 
$
76,879,455
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Six Months Ended June 30,
 
   
2021
   
2020
 
CASH FLOWS FROM OPERATING ACTIVITIES:
           
Net loss
 
$
(37,285,244
)
 
$
(39,423,321
)
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
   
2,555,622
     
1,674,490
 
Loss on disposal of fixed assets
   
78,135
     
3,518
 
Stock-based compensation
   
1,586,586
     
1,392,156
 
Amortization of debt discount
   
908,151
     
874,732
 
Amortization of license revenue
   
(71,417
)
   
(71,417
)
Changes in operating assets and liabilities:
               
Accounts receivable
   
(10,307,304
)
   
(3,044,246
)
Inventories
   
(18,164,144
)
   
(2,936,614
)
Prepaid expenses and other current assets
   
(2,655,397
)
   
(2,159,834
)
Deposits and other assets
   
(144,657
)
   
(283,195
)
Accounts payable
   
(4,906,244
)
   
(2,264,932
)
Accrued expenses
   
2,980,534
     
399,295
 
Other current and non-current liabilities
   
(65,984
)
   
(92,067
)
Net cash used in operating activities
   
(65,491,363
)
   
(45,931,435
)
                 
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Purchase of property and equipment
   
(7,046,735
)
   
(6,243,284
)
Proceeds from the sale of property and equipment
   
-
     
2,000
 
Net cash used in investing activities
   
(7,046,735
)
   
(6,241,284
)
                 
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Proceeds from issuance of common stock, net of offering expenses
   
59,102,075
     
88,704,039
 
Proceeds from the exercise of stock options
   
-
     
13,432
 
Taxes paid on vested Restricted Stock Units
   
(59,311
)
   
-
 
Proceeds from issuance of note payable
   
-
     
12,500,000
 
Payments on finance lease obligations
   
(16,860
)
   
(15,765
)
Net cash provided by financing activities
   
59,025,904
     
101,201,706
 
                 
Net (decrease) increase in cash and cash equivalents
   
(13,512,194
)
   
49,028,987
 
Cash and cash equivalents - beginning of period
   
55,921,152
     
26,752,135
 
Cash and cash equivalents - end of period
 
$
42,408,958
   
$
75,781,122
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1.
ORGANIZATION AND BUSINESS


ADMA Biologics, Inc. (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company’s targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.



ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc. (“ADMA BioCenters”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with Biotest AG, “Biotest”) on June 6, 2017. The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the FDA-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”). BTBU had previously been the Company’s third-party contract manufacturer. ADMA BioCenters is the Company’s source plasma collection business with eight plasma collection facilities in various stages of approval and development located throughout the U.S., two of which hold an approved license with the U.S. Food and Drug Administration (the “FDA”) while a third facility has a Biologics License Application (“BLA”) pending FDA approval.



The Company has three FDA-approved products, all of which are currently marketed and commercially available: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”), and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which the Company received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B. In addition to its commercially available immunoglobulin products, the Company provides contract manufacturing and laboratory services for certain clients and generates revenues from the sale of intermediate by-products that result from the immunoglobulin production process. The Company seeks to develop a pipeline of plasma-derived therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases.



As of June 30, 2021, the Company had working capital of $153.2 million, including $42.4 million of cash and cash equivalents. Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash, cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, into the fourth quarter of 2021. In order to have sufficient cash to fund its operations thereafter, the Company anticipates it will need to raise additional capital before the end of the fourth quarter of 2021. These estimates may change based upon several factors, including the success of the Company’s commercial sales of its products, manufacturing ramp-up activities, the acceptability of ADMA’s immune globulin products by physicians, patients or payers and the various financing options that may be available to the Company. In addition, the Company’s end-to-end production cycle from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials. The Company currently has no firm commitments for additional financing, and there can be no assurance that the Company will be able to secure additional financing on terms that are acceptable to the Company, or at all. Furthermore, if the Company’s assumptions underlying its estimated expenses and revenues are incorrect, it may have to raise additional capital sooner than currently anticipated.


5

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Due to numerous risks and uncertainties associated with FDA review, inspections and approvals related to the Company’s products or the labeled indications of such products, ongoing compliance requirements and capacity expansion efforts at the Company’s Boca Facility and future commercialization of the Company’s products, including the Company’s ability to obtain adequate quantities of FDA-approved plasma with proper specifications on acceptable terms for use in the Company’s manufacturing process, as well as the additional uncertainties surrounding the COVID-19 pandemic (see Note 10), the Company is unable to estimate with certainty the amounts of increased capital outlays and operating expenditures required to fund its commercial and development activities. The Company’s current estimates may be subject to change as circumstances regarding its business requirements evolve. Failure to secure any necessary financing in a timely manner and on commercially reasonable terms could have a material adverse effect on the Company’s business plan and financial performance and it could be forced to delay or discontinue its commercialization, product development or clinical activities or delay or discontinue the approval efforts for any of the Company’s products or product candidates. The Company has reported cumulative losses since inception in June 2004 through June 30, 2021 of $377.8 million. As such, these factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments related to the recoverability and classification of asset carrying amounts and the classification of liabilities that might be necessary from the outcome of this uncertainty.


The Company may decide to raise capital through public or private equity offerings or debt financings, or obtain a bank credit facility or enter into corporate collaboration and licensing arrangements. The sale of additional equity or debt securities, if convertible, could result in dilution to the Company’s existing stockholders and, in such event, the market value of its common stock may decline. The incurrence of additional indebtedness would result in increased fixed obligations and could also result in covenants that would restrict the Company’s operations or other financing alternatives. In addition, the Company is exploring additional contract manufacturing arrangements and other business development opportunities, which may provide additional liquidity to the Company.


During the six months ended June 30, 2021, the Company raised $59.1 million from the open market sale agreement dated August 5, 2020, as amended, (the “2020 Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, shares of the Company’s common stock (see Note 8). In July of 2021, the Company raised an additional $1.5 million under the 2020 Sale Agreement, and the Company has reached the maximum amount of funds that can be raised under the 2020 Sale Agreement.


On May 28, 2021, the Company entered into a new Open Market Sale AgreementSM (the “2021 Sale Agreement”) with Jefferies, pursuant to which the Company may offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50,000,000 of shares of the Company’s common stock. As of August 11, 2021, there have been no sales of common stock under the 2021 Sale Agreement.


There can be no assurance that the Company’s approved products will be commercially viable, or that research and development, plant capacity expansion, plasma center build-outs or other capital improvements will be successfully completed or that any product developed in the future will be approved. The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing industries including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.

2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of presentation


The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (the “FASB”).


6

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2021.  The accompanying consolidated balance sheet as of December 31, 2020 was derived from the audited financial statements as of and for the year ended December 31, 2020. These condensed consolidated interim financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X, and therefore omit or condense certain footnotes and other information normally included in complete consolidated financial statements prepared in accordance with U.S. GAAP. All intercompany balances and transactions have been eliminated in consolidation.  In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2021 and its results of operations, changes in equity and cash flows for the three and six months ended June 30, 2021.


During the three and six months ended June 30, 2021 and 2020, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying condensed consolidated statements of operations.   Operating results for interim periods are not necessarily indicative of the results that may be expected for the full fiscal year.

Use of estimates


The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets.

Fair value of financial instruments


The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and accounts payable, are shown at cost which approximates fair value due to the short-term nature of these instruments.  The debt outstanding under the Company’s senior secured term loan (see Note 7) approximates fair value due to the variable interest rate on this debt.

Accounts receivable


Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $0.2 million and $0.1 million at June 30, 2021 and December 31, 2020, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Based on these evaluations, the Company has concluded that its credit risk is minimal. At June 30, 2021, six customers accounted for an aggregate of 94% of the Company’s total accounts receivable, and at December 31, 2020, three customers accounted for approximately 92% of the Company’s total accounts receivable.

Inventories


Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility.



Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Net realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Goodwill


Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company.  Goodwill at June 30, 2021 and December 31, 2020 was $3.5 million.  All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the 2017 Biotest Transaction.


Goodwill is not amortized but is assessed for impairment on an annual basis or more frequently if impairment indicators exist. The Company has the option to perform a qualitative assessment of goodwill to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill and other intangible assets. If the Company concludes that this is the case, then it must perform a goodwill impairment test by comparing the fair value of the reporting unit to its carrying value. An impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value, not to exceed the total amount of goodwill allocated to that reporting unit. The Company performs its annual goodwill impairment test as of October 1 of each year.  The Company’s annual goodwill impairment test as of October 1, 2020 did not result in a goodwill impairment charge, and the Company did not record any impairment charges related to goodwill for the three and six months ended June 30, 2021 and 2020.

Impairment of long-lived assets


The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the three and six months ended June 30, 2021 and 2020, the Company determined that there was no impairment of its long-lived assets.

Revenue recognition


Revenues for the three and six months ended June 30, 2021 and 2020 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected through the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved. Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years.


Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company.

8

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment.


For the six months ended June 30, 2021, five customers represented an aggregate of 85% of the Company’s consolidated revenues. For the six months ended June 30, 2020, three customers represented an aggregate of 81% of the Company’s consolidated revenues.

Cost of product revenue


Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products, intermediates and the sale of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products. When the activities of these operations are attributable to new products in development, the expenses are classified as research and development expenses.

Loss per common share


Basic loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period.  Diluted loss per common share is calculated by dividing net loss attributable to common stockholders, as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of common stock and dilutive common stock outstanding during the period. Potentially dilutive common stock includes the shares of common stock issuable upon the exercise of outstanding stock options and warrants, using the treasury stock method. Potentially dilutive common stock is excluded from the diluted loss per common share computation to the extent that it would be anti-dilutive. As a result, no potentially dilutive securities are included in the computation of any of the accompanying diluted loss per share amounts in the accompanying condensed consolidated financial statements as the Company reported a net loss for all periods presented. For the six months ended June 30, 2021 and 2020, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects:

   
For the Six Months Ended June 30,
 
   
2021
   
2020
 
Stock options
   
7,783,029
     
6,801,779
 
Restricted stock units
   
686,133
     
326,000
 
Warrants
   
4,528,160
     
2,138,160
 
     
12,997,322
     
9,265,939
 

Stock-based compensation


The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options, to be recognized in the statement of operations as compensation expense based on their fair values at the date of grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis over the associated vesting period of the award based on the grant date fair value of the award. Stock options granted under the Company’s equity incentive plans generally have a four-year vesting period and a term of 10 years. Pursuant to ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), the Company has elected not to establish a forfeiture rate, as stock-based compensation expense related to forfeitures of unvested stock options is fully reversed at the time of forfeiture.

Income Taxes


The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or its tax returns. Under this method, deferred tax assets and liabilities are recognized for the temporary differences between the tax bases of assets and liabilities and their respective financial reporting amounts at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred tax assets if it is more likely than not that the Company will not generate sufficient taxable income to utilize its deferred tax assets. The Company is subject to income tax examinations by major taxing authorities for all tax years since 2016 and for previous periods as it relates to the Company’s net operating loss carryforwards.

9

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

In accordance with U.S. GAAP, the Company is required to determine whether a tax position of the Company is more likely than not to be sustained upon examination by the applicable taxing authority, including resolution of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. Based on its analysis, the Company has determined that it has not incurred any liability for unrecognized tax benefits as of June 30, 2021 and December 31, 2020, and during the three and six months ended June 30, 2021 and 2020, the Company recognized no adjustments for uncertain tax positions.

Recent Accounting Pronouncements


In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326) (“ASU 2016-13”), which requires financial assets to be presented at the net amount expected to be collected, with an allowance for credit losses to be deducted from the amortized cost basis of the financial asset such that the net carrying value of the asset is presented as the amount expected to be collected. Under ASU 2016-13, the entity’s statement of operations is required to reflect the measurement of credit losses for newly recognized financial assets, as well as expected increases or decreases in expected credit losses that have taken place during the period. For public business entities, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019.  The Company adopted ASU 2016-13 on January 1, 2020, and the adoption of this update did not have a significant impact on the Company’s consolidated financial statements.

3.
INVENTORIES


The following table provides the components of inventories:

   
June 30,
2021
   
December 31,
2020
 
             
Raw materials
 
$
33,058,221
   
$
32,044,393
 
Work-in-process
   
49,163,125
     
30,293,288
 
Finished goods
   
17,478,397
     
19,197,918
 
Total inventories
 
$
99,699,743
   
$
81,535,599
 


Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB, as there are alternative uses for these materials that provide a probable future benefit or will be consumed in the production of goods expected to be available for sale. All other activities and materials associated with the production of inventories used in research and development activities are expensed as incurred.


Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s immunoglobulin products. Finished goods inventory is comprised of immunoglobulin product inventory and related intermediates that are available for commercial sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
4.
INTANGIBLE ASSETS


Intangible assets at June 30, 2021 and December 31, 2020 consist of the following:

   
June 30, 2021
   
December 31, 2020
 
   
Cost
   
Accumulated
Amortization
   
Net
   
Cost
   
Accumulated
Amortization
   
Net
 
Trademark and other intangible rights related to Nabi-HB
 
$
4,100,046
   
$
2,391,693
   
$
1,708,353
   
$
4,100,046
   
$
2,098,833
   
$
2,001,213
 
Rights to intermediates
   
907,421
     
529,329
     
378,092
     
907,421
     
464,513
     
442,908
 
Customer contract
   
1,076,557
     
1,076,557
     
-
     
1,076,557
     
1,076,557
     
-
 
   
$
6,084,024
   
$
3,997,579
   
$
2,086,445
   
$
6,084,024
   
$
3,639,903
   
$
2,444,121
 


All of the Company’s intangible assets were acquired in the Biotest Transaction. Amortization expense related to these intangible assets was $0.2 million for the three months ended June 30, 2021 and 2020, and $0.4 million for the six months ended June 30, 2021 and 2020. Estimated aggregate future aggregate amortization expense is expected to be as follows:

2021
 
$
357,676
 
2022
   
715,352
 
2023
   
715,352
 
2024
   
298,065
 

5.
PROPERTY AND EQUIPMENT


Property and equipment and related accumulated depreciation are summarized as follows:

   
June 30, 2021
   
December 31, 2020
 
Manufacturing and laboratory equipment
 
$
15,082,205
   
$
14,468,874
 
Office equipment and computer software
   
3,649,504
     
3,253,528
 
Furniture and fixtures
   
2,516,729
     
2,039,398
 
Construction in process
   
5,966,844
     
3,336,557
 
Leasehold improvements
   
7,192,820
     
5,272,490
 
Land
   
4,339,441
     
4,339,441
 
Buildings and building improvements
   
18,694,960
     
17,746,744
 
     
57,442,503
     
50,457,032
 
Less: Accumulated depreciation
   
(10,955,523
)
   
(8,863,942
)
Total property and equipment, net
 
$
46,486,980
   
$
41,593,090
 


Fixed assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s estimated useful life.  Land is not depreciated. The buildings were assigned a useful life of 30 years. Property and equipment other than land and buildings have useful lives ranging from three to 10 years.  Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives.


The Company recorded depreciation expense on property and equipment for the three and six months ended June 30, 2021 of $1.1 million and $2.2 million, respectively. Depreciation expense for the three and six months ended June 30, 2020 was $0.7 million and $1.3 million, respectively.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
6.
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES


Accrued expenses and other current liabilities at June 30, 2021 and December 31, 2020 are as follows:

   
June 30, 2021
   
December 31, 2020
 
Accrued rebates
 
$
3,721,888
   
$
2,604,245
 
Accrued distribution fees
   
1,928,901
     
828,120
 
Accrued payroll
   
691,483
     
734,972
 
Accrued testing
   
1,673,120
     
779,660
 
Accrued incentives
   
1,539,491
     
3,210,884
 
Accrued severance
   
789,534
     
-
 
Other
   
1,145,822
     
207,262
 
Total accrued expenses and other current liabilities
 
$
11,490,239
   
$
8,365,143
 

7.
DEBT


A summary of outstanding senior notes payable is as follows:

   
June 30, 2021
   
December 31, 2020
 
Notes payable
 
$
100,000,000
   
$
100,000,000
 
Less:
               
Debt discount
   
(6,122,983
)
   
(7,031,134
)
Senior notes payable
 
$
93,877,017
   
$
92,968,866
 


Under the Credit Agreement and Guaranty, as amended from time to time, (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”), the Company has a principal balance outstanding to Perceptive in the form of senior secured notes payable to Perceptive aggregating to $100.0 million with a maturity date of March 1, 2024 (the “Maturity Date”), subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement). On the Maturity Date, the Company will pay Perceptive the entire outstanding principal amount and any accrued and unpaid interest thereon. Prior to the Maturity Date, there are no scheduled principal payments due under the Perceptive Credit Agreement.


Borrowings under the Perceptive Credit Agreement bear interest at a rate per annum equal to 7.5% plus the greater of (i) one-month LIBOR and (ii) 3.5%; provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 400 basis points. Accrued interest is payable to Perceptive on the last day of each month during the term of the Perceptive Credit Facility. The rate of interest in effect as of June 30, 2021 was 11.0%, and the Company paid interest to Perceptive during the six months ended June 30, 2021 and 2020 in the amount of $5.5 million and $4.4 million, respectively.



All of the Company’s obligations under the Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property and all of the equity interests in the Company’s subsidiaries. The Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative covenants restrict or limit the ability of the Company and its subsidiaries to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ended June 30, 2019, report revenues for the trailing 12-month period that exceed the amounts set forth in the Perceptive Credit Agreement, which range from $7.0 million for the fiscal quarter ended June 30, 2019 to $55.0 million for the fiscal quarter ending December 31, 2021. At June 30, 2021, the Company was in compliance with all of the covenants contained in the Perceptive Credit Agreement.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

As a result of the fees paid to Perceptive and the value of the warrants issued to Perceptive under the terms of the Perceptive Credit Agreement, the Company recognized an aggregate discount on the senior secured notes in the amount of $7.1 million.  The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method. Based on the fair value of the Perceptive Warrants and the aggregate amount of fees and expenses associated with obtaining the Perceptive Credit Facility, the effective interest rate on senior secured notes payable to Perceptive as of June 30, 2021 was approximately 13.7%.

8.
STOCKHOLDERS’ EQUITY

Preferred Stock


The Company is currently authorized to issue up to 10 million shares of preferred stock, $0.0001, par value per share.  There were no shares of preferred stock outstanding at June 30, 2021 and December 31, 2020.

Common Stock


As of June 30, 2021 and December 31, 2020, the Company was authorized to issue 300,000,000 and 150,000,000 shares, respectively, of its common stock, $0.0001 par value per share, and 131,872,026 and 104,902,888 shares of common stock were outstanding as of June 30, 2021 and December 31, 2020, respectively. On May 27, 2021, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation which increased the number of shares of common stock that the Company is authorized to issue from 150,000,000 to 300,000,000. After giving effect to the 17,073,357 shares reserved for outstanding warrants and awards issued or reserved for future issuance under the Company’s equity incentive plans, as of June 30, 2021 there were 151,054,617 shares of common stock available for issuance.


On August 5, 2020, the Company entered into the 2020 Sale Agreement with Jefferies (see Note 1), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50 million of shares of the Company’s common stock. On November 5, 2020 and February 3, 2021, the Company and Jefferies amended the 2020 Sale Agreement to provide for increases in the aggregate offering amount under the Sale Agreement such that the Company could sell shares having an aggregate offering price of up to $105.4 million under the 2020 Sale Agreement, as amended. During the six months ended June 30, 2021, the Company issued and sold 26,907,753 shares of common stock under the 2020 Sale Agreement and received net proceeds of $59.1 million (see Note 14).


On May 28, 2021, the Company entered into the 2021 Sale Agreement with Jefferies, pursuant to which the Company may offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $50,000,000 of shares of the Company’s common stock. As of the date of this report, there have been no sales of common stock under this agreement.


On February 11, 2020, the Company completed an underwritten public offering of 23,500,000 shares of its common stock for gross proceeds of $82.3 million. On February 21, 2020, the Company sold an additional 3,525,000 shares pursuant to the underwriters’ exercise of their option to purchase additional shares of the Company’s common stock for additional gross proceeds of $12.3 million. The Company received net proceeds, after underwriting discounts and other expenses associated with the offering, of approximately $88.7 million.

Warrants


At June 30, 2021 and December 31, 2020, the Company had outstanding warrants to purchase an aggregate of 4,528,160 shares of common stock, with a weighted average exercise price of $2.82 per share and expiration dates ranging between June 2022 and December 2030.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Equity Incentive Plans


The fair value of stock options granted under the Company’s 2007 Employee Stock Option Plan (the “2007 Plan”) and the ADMA Biologics, Inc. 2014 Omnibus Incentive Compensation Plan, as amended and restated (the “2014 Plan”), was determined on the date of grant using the Black-Scholes option valuation model. The Black-Scholes model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of certain subjective assumptions including the expected stock price volatility. The stock options granted to employees and directors have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate. The following assumptions were used to determine the fair value of options granted during the six months ended June 30, 2021 and 2020:

 
Six Months Ended June 30,
 
2021
 
2020
Expected term
5.5 - 6.3 years
 
5.5 - 6.3 years
Volatility
69%
 
62-67%
Dividend yield
0.0
 
0.0
Risk-free interest rate
0.80-1.14%
 
0.38-1.68%


During the six months ended June 30, 2021 and 2020, the Company granted options to purchase an aggregate of 1,658,050 and 1,232,500 shares of common stock, respectively, to its directors, employees and certain third-party service providers.  The weighted average remaining contractual life of stock options outstanding and expected to vest at June 30, 2021 is 6.5 years. The weighted average remaining contractual life of stock options exercisable at June 30, 2021 is 5.2 years.


A summary of the Company’s option activity under the 2007 Plan and 2014 Plan and related information is as follows:

   
Shares
   
Weighted
Average
Exercise Price
 
Options outstanding, vested and expected to vest at December 31, 2020
   
6,922,931
   
$
4.40
 
Forfeited
   
(404,782
)
 
$
2.96
 
Expired
   
(393,170
)
 
$
5.03
 
Granted
   
1,658,050
   
$
2.26
 
Exercised
   
-
   
$
-
 
Options outstanding, vested and expected to vest at June 30, 2021
   
7,783,029
   
$
3.98
 
                 
Options exercisable
   
5,011,506
   
$
4.70
 


As of June 30, 2021, the Company had $4.2 million of unrecognized compensation expense related to options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.6 years.


During the six months ended June 30, 2021 and 2020, the Company granted Restricted Stock Units (“RSUs”) representing an aggregate of 542,244 and 341,000 shares, respectively, to certain management employees of the Company and to members of its Board of Directors.  The RSUs vest annually over a period of four years for employees and semi-annually over a period of one year for directors. During the six months ended June 30, 2021, 87,750 shares vested in connection with grants of RSUs. With respect to these vested RSUs, 26,365 shares valued at approximately $59,000 were withheld by the Company to cover employees’ tax liabilities.  On March 25, 2021, these shares were retired by the Company and were no longer outstanding as of June 30, 2021. A summary of the Company’s unvested RSU activity and related information is as follows:
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
   
Shares
   
Weighted
Average Grant
Date Fair Value
 
Balance at December 31, 2020
   
326,000
   
$
2.81
 
Granted
   
542,244
   
$
2.29
 
Vested
   
(87,750
)
 
$
2.81
 
Forfeited
   
(94,361
)
 
$
2.53
 
Balance at June 30, 2021
   
686,133
   
$
2.44
 


As of June 30, 2021, the Company had $1.5 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 3.3 years.


Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the three months and six months June 30, 2021 and 2020 is as follows:

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Research and development
 
$
42,479
   
$
105,029
   
$
147,706
   
$
198,603
 
Plasma center operating expenses
   
13,637
     
8,510
     
24,455
     
15,754
 
Selling, general and administrative
   
665,836
     
539,256
     
1,254,327
     
1,063,145
 
Cost of product revenue
   
83,237
     
62,813
     
160,098
     
114,654
 
Total stock-based compensation expense
 
$
805,189
   
$
715,608
   
$
1,586,586
   
$
1,392,156
 

9.
RELATED PARTY TRANSACTIONS


The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time to time. Rent expense for the six months ended June 30, 2021 and 2020 amounted to $60,000. Areth is a company controlled by Dr. Jerrold B. Grossman, the Vice Chairman of the Company’s Board of Directors, and Adam S. Grossman, the Company’s President and Chief Executive Officer. The Company also reimburses Areth for office and building related (common area) expenses, equipment and certain other operational expenses, which were not material to the consolidated financial statements for the six months ended June 30, 2021 and 2020. In addition, during the six months ended June 30, 2021, the Company purchased certain specialized medical equipment and services related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”), in the amount of $0.1 million. This amount was immaterial to the consolidated financial statements for the three and six months ended June 30, 2020. Dr. Grossman and Adam Grossman each own shares of Genesis.


See Note 7 for a discussion of the Company’s credit facility and related transactions with Perceptive, a holder of more than 10% of the Company’s common stock.


During the three and six months ended June 30, 2021, in connection with the resignation of Dr. James Mond, the Company’s former Chief Scientific and Medical Officer, the Company recognized an expense and corresponding liability in the amount of $0.8 million for estimated payments to be made under a separation and transition agreement with Dr. Mond. Such payments are to be made in scheduled installments over a period of 10 months.


In connection with the February 2020 public offering of the Company’s common stock (see Note 8) on February 11, 2020: (i) Perceptive Advisors, a principal stockholder of ADMA, purchased 4,563,700 shares of common stock through one of its affiliates, (ii) Dr. Grossman purchased 22,857 shares of common stock directly and 22,857 shares indirectly through an entity he controls, (iii) Lawrence P. Guiheen, a director of the Company, purchased 20,000 shares of  common stock, (iv) Mr. Grossman purchased 28,571 shares of common stock directly and 57,143 shares indirectly through an entity he controls, (v) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 7,142 shares of common stock, and (vi) Dr. Mond purchased 4,285 shares of common stock, all at the public offering price of $3.50 per share.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
10.
COMMITMENTS AND CONTINGENCIES

General Legal Matters


From time to time the Company is or may become subject to certain legal proceedings and claims arising in connection with the normal course of its business. Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition.

COVID-19 Pandemic


The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta variant and other resistant strains of the coronavirus, and its impacts to the Company’s commercial and manufacturing operations and plasma collection facilities, including collections of source plasma, procurement of raw materials and packaging materials, a portion of which are sourced internationally, and the testing of finished drug product that is required prior to its availability for commercial sale.  A substantial portion of such testing has historically been performed by contract laboratories outside the United States.


The Company had experienced some delays with final drug product release testing by third-party vendors. In response to these delays, the Company added additional release testing laboratories to its FDA-approved consortium listed in its drug approval documents which the Company believes has adequately addressed this issue. In addition, due to a combination of previous state and local “shelter-in-place” orders, as well as government stimulus packages, persisting social distancing measures and varying roll-outs of vaccinations by state, the Company has experienced lower than normal donor collections at its FDA approved plasma collection centers. The Company was also subject to delays in shipments of source plasma from its contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture and distribution of its products. The Company is also subject to supply chain delays as a result of certain of its suppliers diverting significant resources towards the rapid development and distribution of COVID-19 vaccines and, as a result, the Company may elect to carry more raw materials inventory than it has in the past. The COVID-19 pandemic has also impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel have faced difficulties communicating directly with physicians and other healthcare professionals, as well as the cancellation or postponement of a number of key scientific and medical meetings, further limiting the Company’s ability to communicate with potential customers.  The Company has implemented a comprehensive suite of virtual engagement initiatives, however, clinician engagement has been reduced due to rapidly evolving COVID-19 priorities at U.S. medical centers.


The pandemic could also impact the Company’s ability to interact with the FDA or other regulatory authorities and may result in delays in the conduct of inspections or review of pending applications or submissions.  During the second quarter of 2021, the Company was notified by the FDA that its submission for the approval of its in-house fill-finish process utilizing a recently installed aseptic filling machine will require a site inspection, either in person or virtually, of the Boca Facility. Although the inspection was completed in July of 2021, the FDA’s review of the Company’s regulatory filing with respect to its in-house fill-finish process and new aseptic filling machine remains ongoing. Although the Company anticipates receiving regulatory approval of this submission in the second half of 2021, no assurances can be provided as to the timing for completion of this FDA review or any other regulatory submissions or applications that may be impacted by restrictions related to COVID-19.


Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial condition or results of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19 pandemic. As a result, the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets.


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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial resources, because the Company is unable to determine the ultimate severity or duration of the pandemic or its long-term effects on, among other things, the global, national or local economies, the capital and credit markets or the Company’s workforce, customers or our suppliers, at this time the Company is unable to predict whether COVID-19 will have a material adverse impact on the Company’s business, financial condition, liquidity and results of operations.

Vendor Commitments


Pursuant to the terms of a plasma purchase agreement with BPC dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the Company agreed to purchase from BPC an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV. The Company must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities.  During 2015, the Company and BPC amended the 2011 Plasma Purchase Agreement to allow the Company the ability to collect its raw material RSV high-titer plasma from other third-party collection organizations, thus allowing the Company to expand its reach for raw material supply as it executes its commercialization plans for ASCENIV. Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties. As part of the closing of the Biotest Transaction, the parties amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction. On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019. On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing antibodies to RSV from Grifols. Pursuant to this amendment, until January 1, 2022, the Company may purchase RSV plasma from Grifols from the two plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation).


On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a 10-year term. On July 19, 2018, the Company and BPC entered into an amendment to the Plasma Supply Agreement to provide, among other things, that in the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price that is within a low double- digit percentage of the price that ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019.


On June 6, 2017, the Company and BPC entered into a Plasma Purchase Agreement (the “2017 Plasma Purchase Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices. The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two terms of two years each upon the mutual written consent of the parties. On July 19, 2018, the Company and BPC entered into an amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC. Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined. Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.

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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Effective as of May 12, 2021, the Company and Grifols amended the foregoing 2017 Plasma Purchase Agreement whereby, among other things, the term of the agreement was extended through December 31, 2022, while certain historical provisions were deleted. In order to maintain a reliable supply of raw material plasma thereafter, the Company is in late-stage discussion with multiple third-party suppliers of NSP to supplement the 2017 Plasma Purchase Agreement, and the Company has also increased the number of planned plasma collection center buildouts and is continuing to increase its plasma collection capabilities at its ADMA BioCenters plasma collection centers business segment.


The Company purchases substantially all of its raw material plasma from Grifols. For the six months ended June 30, 2021, plasma purchases from Grifols totaled $17.5 million, or approximately 67% of the Company’s total inventory purchases. For the six months ended June 30, 2020, plasma purchases from Grifols totaled approximately $3.7 million, representing approximately 42% of the Company’s total inventory purchases.

Post-marketing commitments


In connection with the approval of the BLA for BIVIGAM, on December 19, 2012 Biotest committed to perform two additional post-marketing studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal impairment in BIVIGAM-treated patients with primary humoral immunodeficiency. These studies are still pending completion. ADMA has assumed the remaining obligations, and the costs of the studies will be expensed as incurred as research and development expenses. The Company currently expects both studies to be completed by June of 2023.


In connection with the FDA’s approval of ASCENIV on April 1, 2019, the Company is required to perform a pediatric study to evaluate the safety and efficacy of ASCENIV in children and adolescents. This study is required to be completed by June of 2023.

Employment contracts