☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
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)
|
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
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
Non-accelerated filer ☒
|
Smaller reporting company ☒
|
|
Emerging growth company ☐
|
PART I FINANCIAL INFORMATION
|
|||
Item 1.
|
Financial Statements
|
||
1
|
|||
2
|
|||
3
|
|||
4
|
|||
5
|
|||
Item 2.
|
22 | ||
Item 3.
|
33
|
||
Item 4.
|
33 | ||
34 | |||
Item 1.
|
34 | ||
Item 1A.
|
34 | ||
Item 2.
|
64 | ||
Item 3.
|
64 | ||
Item 4.
|
64 | ||
Item 5.
|
64 | ||
Item 6.
|
64 | ||
|
65 |
• |
our ability to manufacture BIVIGAM and ASCENIV on a commercial scale and further 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 Current Good Manufacturing Practices (“cGMP”) 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, our ability to obtain and maintain regulatory compliance and receive FDA approvals of new plasma collection centers 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 (“IG”) 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;
|
• |
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 and efficiencies 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 positive cash flows 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; and
|
• |
future domestic and global economic conditions including, but not limited to, supply chain constraints, inflationary pressures or performance.
|
Item 1. |
Financial Statements.
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
REVENUES:
|
||||||||
Product revenue
|
$
|
29,067,385
|
$
|
16,012,910
|
||||
License revenue
|
35,708
|
35,708
|
||||||
Total revenues
|
29,103,093
|
16,048,618
|
||||||
Cost of product revenue | 25,441,046 | 17,770,122 | ||||||
Gross profit (loss)
|
3,662,047 | (1,721,504 | ) | |||||
OPERATING EXPENSES:
|
||||||||
Research and development
|
624,111
|
987,649
|
||||||
Plasma center operating expenses
|
3,974,589
|
2,242,343
|
||||||
Amortization of intangible assets
|
178,838
|
178,838
|
||||||
Selling, general and administrative
|
13,699,575
|
10,033,915
|
||||||
Total operating expenses
|
18,477,113
|
13,442,745
|
||||||
LOSS FROM OPERATIONS
|
(14,815,066
|
)
|
(15,164,249
|
)
|
||||
OTHER INCOME (EXPENSE):
|
||||||||
Interest income
|
33,068
|
22,059
|
||||||
Interest expense
|
(3,389,038
|
)
|
(3,195,750
|
)
|
||||
Loss on extinguishment of debt
|
(6,669,941 | ) | - | |||||
Other expense
|
(166,880
|
)
|
(42,001
|
)
|
||||
Other expense, net
|
(10,192,791
|
)
|
(3,215,692
|
)
|
||||
NET LOSS
|
$
|
(25,007,857
|
)
|
$
|
(18,379,941
|
)
|
||
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.13
|
)
|
$
|
(0.16
|
)
|
||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||
Basic and Diluted
|
195,871,932
|
115,661,937
|
Common Stock
|
Additional
Paid-in
|
Accumulated
|
Total
Stockholders’
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance at December 31, 2021
|
195,813,817
|
$
|
19,581
|
$
|
553,265,706
|
$
|
(412,112,721
|
)
|
$
|
141,172,566
|
||||||||||
Stock-based compensation
|
- |
-
|
1,641,388
|
-
|
1,641,388
|
|||||||||||||||
Warrants issued in connection with notes payable | - | - | 9,569,604 | - | 9,569,604 | |||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
|
533,712
|
54
|
(442,690
|
)
|
-
|
(442,636
|
)
|
|||||||||||||
Net loss
|
- | - | - | (25,007,857 | ) | (25,007,857 | ) | |||||||||||||
Balance at March 31, 2022
|
196,347,529 | $ |
19,635 | $ |
564,034,008 | $ |
(437,120,578 | ) | $ |
126,933,065
|
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
|
|||||||||||||||
Issuance of common stock, net of offering expenses
|
18,080,708
|
1,808
|
41,910,707
|
-
|
41,912,515
|
|||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired |
61,385 | 6 | (59,317 | ) | - | (59,311 | ) | |||||||||||||
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
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | (25,007,857 | ) |
$
|
(18,379,941
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
1,590,217
|
1,229,628
|
||||||
Loss on disposal of fixed assets
|
2,000
|
781
|
||||||
Stock-based compensation
|
1,641,388
|
781,397
|
||||||
Amortization of debt discount
|
584,842
|
443,794
|
||||||
Loss on extinguishment of debt
|
6,669,941 | - | ||||||
Amortization of license revenue
|
(35,708
|
)
|
(35,708
|
)
|
||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
2,947,233
|
(2,124,740
|
)
|
|||||
Inventories
|
(14,422,219
|
)
|
(12,610,601
|
)
|
||||
Prepaid expenses and other current assets
|
(1,180,056
|
)
|
(2,756,142
|
)
|
||||
Deposits and other assets
|
1,397,672
|
19,718
|
||||||
Accounts payable
|
1,685,724
|
1,079,144
|
||||||
Accrued expenses
|
(1,775,526
|
)
|
(843,043
|
)
|
||||
Other current and non-current liabilities
|
(111,064
|
)
|
(33,413
|
)
|
||||
Net cash used in operating activities
|
(26,013,413
|
)
|
(33,229,126
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
(2,842,085
|
)
|
(2,571,161
|
)
|
||||
Net cash used in investing activities
|
(2,842,085
|
)
|
(2,571,161
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Principal payments on notes payable
|
(100,000,000 | ) | - | |||||
Proceeds from issuance of common stock, net of offering expenses
|
-
|
41,912,515
|
||||||
Payment of debt refinancing fees
|
(2,000,000
|
)
|
-
|
|||||
Proceeds from issuance of note payable
|
151,750,000 | - | ||||||
Taxes paid on vested Restricted Stock Units
|
(91,367
|
)
|
(59,311
|
)
|
||||
Payments on finance lease obligations
|
(8,941
|
)
|
(8,360
|
)
|
||||
Payment of deferred financing fees
|
(2,378,366 | ) | - | |||||
Net cash provided by financing activities
|
47,271,326
|
41,844,844
|
||||||
Net increase in cash and cash equivalents
|
18,415,828
|
6,044,557
|
||||||
Cash and cash equivalents - beginning of year
|
51,089,118
|
55,921,152
|
||||||
Cash and cash equivalents - end of period
|
$
|
69,504,946
|
$
|
61,965,709
|
1. |
ORGANIZATION AND BUSINESS
|
2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
For the Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Stock options
|
8,686,068
|
8,103,165
|
||||||
Restricted stock units
|
4,729,758
|
730,994
|
||||||
Warrants
|
13,631,207
|
4,528,160
|
||||||
27,047,033
|
13,362,319
|
3. |
INVENTORIES
|
March 31,
2022
|
December 31,
2021
|
|||||||
Raw materials
|
$
|
46,034,969
|
$
|
36,755,720
|
||||
Work-in-process
|
45,139,511
|
58,968,535
|
||||||
Finished goods
|
47,971,831
|
28,999,836
|
||||||
Total inventories
|
$
|
139,146,311
|
$
|
124,724,091
|
4. |
INTANGIBLE ASSETS
|
March 31, 2022
|
December 31, 2021
|
|||||||||||||||||||||||
Cost
|
Accumulated
Amortization |
Net
|
Cost
|
Accumulated
Amortization |
Net
|
|||||||||||||||||||
Trademark and other intangible rights related to Nabi-HB
|
$
|
4,100,046
|
$
|
2,830,985
|
$
|
1,269,061
|
$
|
4,100,046
|
$
|
2,684,554
|
$
|
1,415,492
|
||||||||||||
Rights to intermediates
|
907,421
|
626,552
|
280,869
|
907,421
|
594,145
|
313,276
|
||||||||||||||||||
$
|
5,007,467
|
$
|
3,457,537
|
$
|
1,549,930
|
$
|
5,007,467
|
$
|
3,278,699
|
$
|
1,728,768
|
Remainder of 2022
|
$
|
536,514
|
||
2023
|
715,352
|
|||
2024
|
298,064
|
5. |
PROPERTY AND EQUIPMENT
|
March 31, 2022
|
December 31, 2021
|
|||||||
Manufacturing and laboratory equipment
|
$
|
17,100,261
|
$
|
16,702,991
|
||||
Office equipment and computer software
|
4,323,549
|
4,082,462
|
||||||
Furniture and fixtures
|
3,693,317
|
3,389,140
|
||||||
Construction in process
|
6,384,242
|
5,496,222
|
||||||
Leasehold improvements
|
12,966,337
|
11,129,639
|
||||||
Land
|
4,339,441
|
4,339,441
|
||||||
Buildings and building improvements
|
19,093,765
|
19,067,032
|
||||||
67,900,912
|
64,206,927
|
|||||||
Less: Accumulated depreciation
|
(14,680,432
|
)
|
(13,271,853
|
)
|
||||
Total property, plant and equipment, net
|
$
|
53,220,480
|
$
|
50,935,074
|
6. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
|
March 31, 2022
|
December 31, 2021
|
|||||||
Accrued rebates
|
$
|
6,324,746
|
$
|
5,040,200
|
||||
Accrued distribution fees
|
2,794,447
|
4,739,651
|
||||||
Accrued incentives
|
1,565,993
|
4,066,109
|
||||||
Accrued testing
|
674,191
|
1,189,970
|
||||||
Accrued payroll
|
2,206,409
|
1,167,072
|
||||||
Other
|
3,088,754
|
1,011,986
|
||||||
Total accrued expenses and other current liabilities
|
$
|
16,654,540
|
$
|
17,214,988
|
7. |
DEBT
|
March 31, 2022
|
December 31, 2021
|
|||||||
Notes payable
|
$
|
151,750,000
|
$
|
100,000,000
|
||||
Less:
|
||||||||
Debt discount
|
(13,326,948
|
)
|
(5,133,761
|
)
|
||||
Senior notes payable
|
$
|
138,423,052
|
$
|
94,866,239
|
8. |
STOCKHOLDERS’ EQUITY
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Expected term
|
5.5 - 6.3 years
|
5.5 - 6.3 years
|
||||||
Volatility
|
68 | % | 69 | % | ||||
Dividend yield
|
0.0
|
0.0
|
||||||
Risk-free interest rate
|
1.72-1.73
|
%
|
0.80-1.04
|
%
|
Shares
|
Weighted
Average
Exercise Price
|
|||||||
Options outstanding, vested and expected to vest at December 31, 2021
|
7,862,722
|
$
|
3.93
|
|||||
Forfeited
|
(9,186
|
)
|
$
|
2.13
|
||||
Expired
|
(361,500
|
)
|
$
|
6.48
|
||||
Granted
|
1,194,032
|
$
|
1.67
|
|||||
Options outstanding, vested and expected to vest at March 31, 2022
|
8,686,068
|
$
|
3.51
|
|||||
Options exercisable
|
5,646,819
|
$
|
4.25
|
Shares
|
Weighted
Average Grant
Date Fair Value
|
|||||||
Balance at December 31, 2021
|
4,485,133
|
$
|
1.34
|
|||||
Granted
|
1,059,266
|
$
|
1.67
|
|||||
Vested
|
(799,641
|
)
|
$
|
1.41
|
||||
Forfeited
|
(15,000
|
)
|
$
|
1.22
|
||||
Balance at March 31, 2022
|
4,729,758
|
$
|
1.41
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Research and development
|
$
|
4,671
|
$
|
105,227
|
||||
Plasma center operating expenses
|
21,052
|
10,818
|
||||||
Selling, general and administrative
|
1,517,602
|
588,491
|
||||||
Cost of product revenue
|
98,063
|
76,861
|
||||||
Total stock-based compensation expense
|
$
|
1,641,388
|
$
|
781,397
|
9. |
RELATED PARTY TRANSACTIONS
|
10. |
COMMITMENTS AND CONTINGENCIES
|
11. |
SEGMENTS
|
Three Months Ended March 31, 2022
|
||||||||||||||||
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
Revenues
|
$
|
25,728,625
|
$
|
3,338,760
|
$
|
35,708
|
$
|
29,103,093
|
||||||||
Cost of product revenue
|
22,213,781
|
3,227,265
|
-
|
25,441,046
|
||||||||||||
Loss from operations
|
(4,442,684
|
)
|
(3,863,094
|
)
|
(6,509,288
|
)
|
(14,815,066
|
)
|
||||||||
Interest and other expense, net
|
(49,267
|
)
|
(729
|
)
|
(3,472,854
|
)
|
(3,522,850
|
)
|
||||||||
Loss on extinguishment of debt |
- | - | (6,669,941 | ) | (6,669,941 | ) | ||||||||||
Net loss
|
(4,491,951
|
)
|
(3,863,823
|
)
|
(16,652,083
|
)
|
(25,007,857
|
)
|
||||||||
Capital expenditures |
1,310,379 | 1,531,706 | - | 2,842,085 | ||||||||||||
Depreciation and amortization expense
|
1,111,951
|
477,503
|
763
|
1,590,217
|
||||||||||||
Total assets
|
214,150,322
|
32,568,911
|
61,313,259
|
308,032,492
|
Three Months Ended March 31, 2021
|
||||||||||||||||
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
Revenues
|
$
|
13,421,043
|
$
|
2,591,867
|
$
|
35,708
|
$
|
16,048,618
|
||||||||
Cost of product revenue
|
15,449,757
|
2,320,365
|
-
|
17,770,122
|
||||||||||||
Loss from operations
|
(9,505,689
|
)
|
(1,970,841
|
)
|
(3,687,719
|
)
|
(15,164,249
|
)
|
||||||||
Interest and other expense, net
|
(21,513
|
)
|
(384
|
)
|
(3,193,795
|
)
|
(3,215,692
|
)
|
||||||||
Net loss
|
(9,527,202
|
)
|
(1,971,225
|
)
|
(6,881,514
|
)
|
(18,379,941
|
)
|
||||||||
Capital expenditures |
1,012,980 | 1,558,181 | - | 2,571,161 | ||||||||||||
Depreciation and amortization expense
|
1,009,770
|
217,991
|
1,867
|
1,229,628
|
||||||||||||
Total assets
|
156,535,177
|
17,397,612
|
61,734,239
|
235,667,028
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
United States
|
$
|
27,316,151
|
$
|
13,678,008
|
||||
International
|
1,786,942
|
2,370,610
|
||||||
Total revenues
|
$
|
29,103,093
|
$
|
16,048,618
|
12. |
LEASE OBLIGATIONS
|
Remainder of 2022
|
$
|
1,228,526
|
|||
Year ended December 31, 2023
|
1,641,603
|
||||
2024
|
1,517,229
|
||||
2025
|
1,525,793
|
||||
2026
|
1,260,391
|
||||
2027
|
1,289,679
|
||||
Thereafter
|
5,055,880
|
||||
Total payments
|
13,519,101
|
||||
Less: imputed interest
|
(5,581,019
|
)
|
|||
Current portion
|
(654,003
|
)
|
|||
Balance at March 31, 2022
|
$
|
7,284,079
|
13. |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
2022
|
2021
|
|||||||
SUPPLEMENTAL CASH FLOW INFORMATION:
|
||||||||
Cash paid for interest
|
$
|
2,525,987
|
$
|
2,751,956
|
||||
Noncash Financing and Investing Activities:
|
||||||||
Equipment acquired reflected in accounts payable and accrued liabilities
|
$
|
1,940,425
|
$
|
1,797,249
|
||||
Right-to-use assets in exchange for lease obligations
|
$
|
-
|
$
|
2,073,627
|
||||
Warrants issued in connection with notes payable
|
$ |
9,569,604 |
$ |
- |
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
• |
A significant adverse change in legal factors or in the business climate that could affect the value of the asset.
|
• |
Significant and continued cash flow losses.
|
• |
A significant adverse change in the extent or manner in which an asset is used, such as a restriction imposed by the FDA or other regulatory authorities that could affect our ability to manufacture our products using a particular
asset.
|
• |
An expectation of losses or reduced profits associated with an asset. This could result, for example, from the introduction of a competitor’s product that impacts projected revenue growth, or a change in the acceptance of a product
by patients, physicians and payers that results in an inability to sustain projected product revenues.
|
Three Months Ended March 31,
|
||||||||||||
2022
|
2021
|
Increase (Decrease)
|
||||||||||
Revenues
|
$
|
29,103,093
|
$
|
16,048,618
|
$
|
13,054,475
|
||||||
Cost of product revenue
|
25,441,046
|
17,770,122
|
7,670,924
|
|||||||||
Gross profit (loss)
|
3,662,047
|
(1,721,504
|
)
|
5,383,551
|
||||||||
Research and development expenses
|
624,111
|
987,649
|
(363,538
|
)
|
||||||||
Plasma center operating expenses
|
3,974,589
|
2,242,343
|
1,732,246
|
|||||||||
Amortization of intangibles
|
178,838
|
178,838
|
-
|
|||||||||
Selling, general and administrative expenses
|
13,699,575
|
10,033,915
|
3,665,660
|
|||||||||
Loss from operations
|
(14,815,066
|
)
|
(15,164,249
|
)
|
349,183
|
|||||||
Interest expense
|
(3,389,038
|
)
|
(3,195,750
|
)
|
(193,288
|
)
|
||||||
Loss on extinguishment of debt
|
(6,669,941
|
)
|
-
|
(6,669,941
|
)
|
|||||||
Other expense, net
|
(133,812
|
)
|
(19,942
|
)
|
(113,870
|
)
|
||||||
Net loss
|
$
|
(25,007,857
|
)
|
$
|
(18,379,941
|
)
|
$
|
(6,627,916
|
)
|
• |
The procurement of raw material plasma and other raw materials necessary to maintain and scale up our manufacturing operations;
|
• |
Employee compensation and benefits;
|
• |
Capital expenditures for the building of additional plasma collection facilities and for equipment upgrades and capacity expansion at the Boca Facility;
|
• |
Plasma donor fees and plasma center supplies;
|
• |
Interest on our debt;
|
• |
Marketing programs and continued commercialization efforts;
|
• |
Boca Facility maintenance, repairs and supplies; and
|
• |
Conducting required post-marketing clinical trials for our FDA-approved products.
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Net cash used in operating activities
|
$
|
(26,013,413
|
)
|
$
|
(33,229,126
|
)
|
||
Net cash used in investing activities
|
(2,842,085
|
)
|
(2,571,161
|
)
|
||||
Net cash provided by financing activities
|
47,271,326
|
41,844,844
|
||||||
Net change in cash and cash equivalents
|
18,415,828
|
6,044,557
|
||||||
Cash and cash equivalents - beginning of year
|
51,089,118
|
55,921,152
|
||||||
Cash and cash equivalents - end of period
|
$
|
69,504,946
|
$
|
61,965,709
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Net loss
|
$
|
(25,007,857
|
)
|
$
|
(18,379,941
|
)
|
||
Non-cash expenses, gains and losses
|
10,452,680
|
2,419,892
|
||||||
Changes in accounts receivable
|
2,947,233
|
(2,124,740
|
)
|
|||||
Changes in inventories
|
(14,422,219
|
)
|
(12,610,601
|
)
|
||||
Changes in prepaid expenses and other current assets
|
(1,180,056
|
)
|
(2,756,142
|
)
|
||||
Changes in accounts payable and accrued expenses
|
(89,802
|
)
|
236,101
|
|||||
Other
|
1,286,608
|
(13,695
|
)
|
|||||
Cash used in operations
|
$
|
(26,013,413
|
)
|
$
|
(33,229,126
|
)
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 4. |
Controls and Procedures.
|
Item 1. |
Legal Proceedings.
|
• |
We have a history of losses and we may, in the future, need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.
|
• |
We are currently not profitable and may never become profitable.
|
• |
The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, and could have a material adverse impact on our business, liquidity, financial condition and results of operations, as
well as a change to the overall market size and potential for our products.
|
• |
We contract with third parties for the filling, packaging, testing and labeling of the drug substance we manufacture. This reliance on third parties carries the risk that the services upon which we rely may not be performed in a timely
manner 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.
|
• |
Both of our business segments and our facilities are subject to periodic inspections by the FDA, which, depending on the outcome of such inspections, could result in certain FDA actions, including the issuance of observations, notices,
citations or warning letters.
|
• |
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.
|
• |
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 and FDA could require clinical trials beyond
what we may deem to be reasonable. Unless additional clinical trials are successfully conducted and the FDA approves a BLA or other required submission for review, we may not be authorized to market ASCENIV for any other indication.
|
• |
With the approval to market ASCENIV, BIVIGAM and Nabi-HB, there can be no assurance that we will be successful in further developing and expanding commercial operations 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, and such parties are 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 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 achieve profitability may be adversely impacted.
|
• |
Our ADMA BioCenters operations collect information from donors in the U.S. that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail to meet their requirements.
|
• |
Our senior credit facility with Hayfin Services LLP (“Hayfin”) is subject to acceleration in specified circumstances, which may result in Hayfin taking possession and disposing of any collateral.
|
• |
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.
|
• |
Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation.
|
• |
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 against transmittable
diseases.
|
• |
We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source plasma with proper specifications or other necessary raw materials.
|
• |
We require additional funding and may be unable to raise capital in the future, which would force us to delay, curtail or eliminate one or more of our research and development programs or potentially modify our ongoing operations,
commercialization efforts and expansion plans, as well as impact the overall business plan for the organization.
|
• |
The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
|