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These terms and conditions govern your use of the website alphaminr.com and its related services.
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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-
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Large accelerated filer ☐
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Accelerated filer ☐
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Smaller reporting company
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Emerging growth company
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Item 1.
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1
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1
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2
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3
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4
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Item 2.
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23
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Item 3.
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Item 4.
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39
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Item 1.
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39
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Item 1A.
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Item 2.
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69
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Item 3.
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70
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Item 4.
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Item 5.
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Item 6.
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• |
our ability to continue as a going concern;
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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;
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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;
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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;
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the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates;
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our dependence upon our third-party customers and vendors and their compliance with applicable regulatory requirements;
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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;
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our ability to obtain adequate quantities of FDA-approved plasma with proper specifications;
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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;
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the potential indications for our products and product candidates;
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potential investigational new product applications;
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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;
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our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses;
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Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions;
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concurrence by the FDA with our conclusions concerning our products and product candidates;
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the comparability of results of our hyperimmune and immune globulin
(“IG”)
products
to other comparably run hyperimmune and immune globulin clinical trials;
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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;
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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;
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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;
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our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy;
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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;
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our estimates regarding revenues, expenses, capital requirements, timing to profitability and the need for and availability of additional financing;
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possible or likely reimbursement levels for our currently marketed products;
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estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM;
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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;
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future domestic and global economic conditions or performance; and
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expectations for future capital requirements.
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| Item 1 . |
Financial Statements.
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September 30,
2021
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December 31,
2020
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|||||||
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(Unaudited)
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||||||||
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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$
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Accounts receivable, net
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Inventories
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Prepaid expenses and other current assets
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Total current assets
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Property and equipment, net
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Intangible assets, net
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Goodwill
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Right to use assets
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Deposits and other assets
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TOTAL ASSETS
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$
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$
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities:
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Accounts payable
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$
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$
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Accrued expenses and other current liabilities
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Current portion of deferred revenue
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Current portion of lease obligations
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Total current liabilities
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Senior notes payable, net of discount
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Deferred revenue, net of current portion
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Lease obligations, net of current portion
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Other non-current liabilities
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TOTAL LIABILITIES
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COMMITMENTS AND CONTINGENCIES
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STOCKHOLDERS’ EQUITY
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Preferred Stock, $
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Common Stock - voting, $
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Additional paid-in capital
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Accumulated deficit
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(
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(
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||||
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TOTAL STOCKHOLDERS’ EQUITY
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
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$
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$
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2021
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2020
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2021
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2020
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REVENUES:
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Product revenue
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$
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$
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$
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$
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License revenue
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Total revenues
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OPERATING EXPENSES:
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Cost of product revenue (exclusive of amortization expense shown below)
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Research and development
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Plasma center operating expenses
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Amortization of intangible assets
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Selling, general and administrative
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Total operating expenses
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LOSS FROM OPERATIONS
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(
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(
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(
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(
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||||||||
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OTHER INCOME (EXPENSE):
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Interest income
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Interest expense
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(
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(
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(
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(
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||||||||
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Other income (expense)
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(
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(
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(
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||||||||
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Other expense, net
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(
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(
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(
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(
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||||||||
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NET LOSS
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$
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(
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$
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(
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$
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(
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$
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(
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)
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||||
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BASIC AND DILUTED LOSS PER COMMON SHARE
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$
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(
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$
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(
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$
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(
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$
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(
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||||
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WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
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Basic and Diluted
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||||||||||||
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Common Stock
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Additional
Paid-in
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Accumulated
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Total
Stockholders’
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|||||||||||||||||
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Shares
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Amount
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Capital
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Deficit
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Equity
|
||||||||||||||||
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Balance at December 31,
2020
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$
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$
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$
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(
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)
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$
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||||||||||
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Stock-based compensation
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-
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|||||||||||||||
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Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
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(
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)
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(
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|||||||||||||
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Issuance of common stock, net of offering expenses
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|||||||||||||||
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Net loss
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-
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(
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)
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(
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)
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|||||||||||||
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Balance at March 31,
2021
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(
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)
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||||||||||||||
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Stock-based compensation
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-
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|||||||||||||||
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Issuance of common stock, net of offering expenses
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|||||||||||||||
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Net loss
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-
|
|
|
(
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)
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(
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)
|
|||||||||||||
| Balance at June 30, 2021 |
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|
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(
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) |
|
||||||||||||||
| Issuance of common stock, net of offering expenses |
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|
|
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|
|||||||||||||||
| Vesting of Restricted Stock Units, net of shares withheld for taxes and retired |
|
|
(
|
) |
|
(
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) | |||||||||||||
| Stock-based compensation |
-
|
|
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|
|
|||||||||||||||
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Net loss
|
-
|
|
|
(
|
) |
(
|
) | |||||||||||||
|
Balance at September 30,
2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
Common Stock
|
Additional
Paid-in
|
Accumulated
|
Total
Stockholders’
|
|||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
|
Balance at December 31,
2019
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
Stock-based compensation
|
-
|
|
|
|
|
|||||||||||||||
|
Issuance of common stock, net of offering expenses
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|
|
|
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|
|||||||||||||||
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Exercise of stock options
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|
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|
|
|
|||||||||||||||
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Net loss
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-
|
|
|
(
|
)
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(
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)
|
|||||||||||||
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Balance at March 31,
2020
|
|
|
|
(
|
)
|
|
||||||||||||||
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Stock-based compensation
|
-
|
|
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|
|||||||||||||||
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Exercise of stock options
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|||||||||||||||
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Net loss
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-
|
|
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(
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)
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(
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)
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|||||||||||||
| Balance at June 30, 2020 |
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(
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) |
|
||||||||||||||
| Stock-based compensation |
-
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|||||||||||||||
| Vesting of restricted stock units |
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(
|
) |
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||||||||||||||
| Issuance of common stock, net of offering expenses |
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|||||||||||||||
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Net loss
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-
|
|
|
(
|
) |
(
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) | |||||||||||||
|
Balance at September 30,
2020
|
|
$
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$
|
|
$
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(
|
)
|
$
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|
||||||||||
|
Nine Months Ended September 30,
|
||||||||
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2021
|
2020
|
|||||||
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CASH FLOWS FROM OPERATING ACTIVITIES:
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||||||||
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Net loss
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$
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(
|
)
|
$
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(
|
)
|
||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
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Depreciation and amortization
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|
||||||
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Loss on disposal of fixed assets
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|
||||||
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Stock-based compensation
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|
||||||
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Amortization of debt discount
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|
||||||
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Amortization of license revenue
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(
|
)
|
(
|
)
|
||||
|
Changes in operating assets and liabilities:
|
||||||||
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Accounts receivable
|
(
|
)
|
(
|
)
|
||||
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Inventories
|
(
|
)
|
(
|
)
|
||||
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Prepaid expenses and other current assets
|
(
|
)
|
(
|
)
|
||||
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Deposits and other assets
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(
|
)
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(
|
)
|
||||
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Accounts payable
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|
(
|
)
|
||||
|
Accrued expenses
|
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|
||||||
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Other current and non-current liabilities
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(
|
)
|
||||
|
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
|
Proceeds from the sale of property and equipment
|
|
|
||||||
|
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from issuance of common stock, net of offering expenses
|
|
|
||||||
|
Proceeds from the exercise of stock options
|
|
|
||||||
|
Taxes paid on vested Restricted Stock Units
|
(
|
)
|
|
|||||
|
Proceeds from issuance of note payable
|
|
|
||||||
|
Payments on finance lease obligations
|
(
|
)
|
(
|
)
|
||||
|
Net cash provided by financing activities
|
|
|
||||||
|
Net (decrease) increase in cash and cash equivalents
|
(
|
)
|
|
|||||
|
Cash and cash equivalents - beginning of period
|
|
|
||||||
|
Cash and cash equivalents - end of period
|
$
|
|
$
|
|
||||
| 1. |
ORGANIZATION AND BUSINESS
|
| 2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
For the Nine Months Ended September 30,
|
||||||||
|
2021
|
2020
|
|||||||
|
Stock options
|
|
|
||||||
|
Restricted stock units
|
|
|
||||||
|
Warrants
|
|
|
||||||
|
|
|
|||||||
| 3. |
INVENTORIES
|
|
September 30,
2021
|
December 31,
2020
|
|||||||
|
Raw materials
|
$
|
|
$
|
|
||||
|
Work-in-process
|
|
|
||||||
|
Finished goods
|
|
|
||||||
|
Total inventories
|
$
|
|
$
|
|
||||
| 4. |
INTANGIBLE ASSETS
|
|
September 30, 2021
|
December 31, 2020
|
|||||||||||||||||||||||
|
Cost
|
Accumulated
Amortization
|
Net
|
Cost
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||
|
Trademark and other intangible rights related to Nabi-HB
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
|
Rights to intermediates
|
|
|
|
|
|
|
||||||||||||||||||
|
Customer contract
|
|
|
|
|
|
|
||||||||||||||||||
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|||||||||||||
|
Remainder of
2021
|
$
|
|
||
|
2022
|
|
|||
|
2023
|
|
|||
|
2024
|
|
| 5. |
PROPERTY AND EQUIPMENT
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
|
Manufacturing and laboratory equipment
|
$
|
|
$
|
|
||||
|
Office equipment and computer software
|
|
|
||||||
|
Furniture and fixtures
|
|
|
||||||
|
Construction in process
|
|
|
||||||
|
Leasehold improvements
|
|
|
||||||
|
Land
|
|
|
||||||
|
Buildings and building improvements
|
|
|
||||||
|
|
|
|||||||
|
Less: Accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
|
Total property and equipment, net
|
$
|
|
$
|
|
||||
| 6. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
|
Accrued rebates
|
$
|
|
$
|
|
||||
|
Accrued distribution fees
|
|
|
||||||
|
Accrued payroll
|
|
|
||||||
|
Accrued testing
|
|
|
||||||
|
Accrued incentives
|
|
|
||||||
|
Accrued severance
|
|
|
||||||
|
Other
|
|
|
||||||
|
Total accrued expenses and other current liabilities
|
$
|
|
$
|
|
||||
| 7. |
DEBT
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
|
Notes payable
|
$
|
|
$
|
|
||||
|
Less:
|
||||||||
|
Debt discount
|
(
|
)
|
(
|
)
|
||||
|
Senior notes payable
|
$
|
|
$
|
|
||||
| 8. |
STOCKHOLDERS’ EQUITY
|
|
Nine Months Ended September 30,
|
||||||||
|
2021
|
2020
|
|||||||
|
Expected term
|
|
|
||||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Dividend yield
|
|
|
||||||
|
Risk-free interest rate
|
|
%
|
|
%
|
||||
|
Shares
|
Weighted
Average
Exercise Price
|
|||||||
|
Options outstanding, vested and expected to vest at
December 31, 2020
|
|
$
|
|
|||||
|
Forfeited
|
(
|
)
|
$
|
|
||||
|
Expired
|
(
|
)
|
$
|
|
||||
|
Granted
|
|
$
|
|
|||||
|
Exercised
|
|
$
|
|
|||||
|
Options outstanding, vested and expected to vest at
September 30, 2021
|
|
$
|
|
|||||
|
Options exercisable
|
|
$
|
|
|||||
|
Shares
|
Weighted
Average Grant
Date Fair Value
|
|||||||
|
Balance at
December 31, 2020
|
|
$
|
|
|||||
|
Granted
|
|
$
|
|
|||||
|
Vested
|
(
|
)
|
$
|
|
||||
|
Forfeited
|
(
|
)
|
$
|
|
||||
|
Balance at
September 30, 2021
|
|
$
|
|
|||||
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Plasma center operating expenses
|
|
|
|
|
||||||||||||
|
Selling, general and administrative
|
|
|
|
|
||||||||||||
|
Cost of product revenue
|
|
|
|
|
||||||||||||
|
Total stock-based compensation expense
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
| 9. |
RELATED PARTY TRANSACTIONS
|
| 10. |
COMMITMENTS AND CONTINGENCIES
|
| 11. |
SEGMENTS
|
|
Three Months Ended September 30, 2021
|
||||||||||||||||
|
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Cost of product revenue
|
|
|
|
|
||||||||||||
|
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Interest and other income (expense), net
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Depreciation and amortization expense
|
|
|
|
|
||||||||||||
|
Total assets
|
|
|
|
|
||||||||||||
|
Three Months Ended September 30, 2020
|
||||||||||||||||
|
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Cost of product revenue
|
|
|
|
|
||||||||||||
|
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Interest and other expense, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Depreciation and amortization expense
|
|
|
|
|
||||||||||||
|
Total assets
|
|
|
|
|
||||||||||||
|
Nine Months Ended September 30, 2021
|
||||||||||||||||
|
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Cost of product revenue
|
|
|
|
|
||||||||||||
|
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Interest and other expense, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Capital expenditures
|
|
|
|
|
||||||||||||
|
Depreciation and amortization expense
|
|
|
|
|
||||||||||||
|
Nine Months Ended September 30, 2020
|
||||||||||||||||
|
ADMA
BioManufacturing
|
Plasma Collection
Centers
|
Corporate
|
Consolidated
|
|||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Cost of product revenue
|
|
|
|
|
||||||||||||
|
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Interest and other expense, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
Capital expenditures
|
|
|
|
|
||||||||||||
|
Depreciation and amortization expense
|
|
|
|
|
||||||||||||
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
United States
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
International
|
|
|
|
|
||||||||||||
|
Total revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
| 12. |
LEASE OBLIGATIONS
|
|
Remainder of
2021
|
$
|
|
|||
|
Year ended December 31,
2022
|
|
||||
|
2023
|
|
||||
|
2024
|
|
||||
|
2025
|
|
||||
|
2026
|
|
||||
|
Thereafter
|
|
||||
|
Total payments
|
|
||||
|
Less: imputed interest
|
(
|
)
|
|||
|
Current portion
|
(
|
)
|
|||
|
Balance at
September 30, 2021
|
$
|
|
| 13. |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
|
2021
|
2020
|
|||||||
|
SUPPLEMENTAL CASH FLOW INFORMATION:
|
||||||||
|
Cash paid for interest
|
$
|
|
$
|
|
||||
|
Non-cash Financing and Investing Activities:
|
||||||||
|
Equipment acquired reflected in accounts payable and accrued liabilities
|
$
|
|
$
|
|
||||
|
Right-to-use assets in exchange for lease obligations
|
$
|
|
$
|
|
||||
| 14. |
SUBSEQUENT EVENTS
|
| Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
|
Three Months Ended September 30,
|
||||||||||||
|
2021
|
2020
|
Increase (Decrease)
|
||||||||||
|
Revenues
|
$
|
20,680,550
|
$
|
10,276,358
|
$
|
10,404,192
|
||||||
|
Cost of product revenue (exclusive of amortization expense shown below)
|
20,295,213
|
11,855,464
|
8,439,749
|
|||||||||
|
Gross profit (loss)
|
385,337
|
(1,579,106
|
)
|
1,964,443
|
||||||||
|
Research and development expenses
|
770,557
|
1,708,391
|
(937,834
|
)
|
||||||||
|
Plasma center operating expenses
|
3,146,221
|
1,218,898
|
1,927,323
|
|||||||||
|
Amortization of intangibles
|
178,838
|
178,838
|
-
|
|||||||||
|
Selling, general and administrative expenses
|
10,726,797
|
9,115,744
|
1,611,053
|
|||||||||
|
Loss from operations
|
(14,437,076
|
)
|
(13,800,977
|
)
|
(636,099
|
)
|
||||||
|
Interest expense
|
(3,298,680
|
)
|
(3,091,200
|
)
|
(207,480
|
)
|
||||||
|
Other income (expense), net
|
22,802
|
(25,276
|
)
|
48,078
|
||||||||
|
Net loss
|
$
|
(17,712,954
|
)
|
$
|
(16,917,453
|
)
|
$
|
(795,501
|
)
|
|||
|
Nine Months Ended September 30,
|
||||||||||||
|
2021
|
2020
|
Increase (Decrease)
|
||||||||||
|
Revenues
|
$
|
54,559,758
|
$
|
28,263,696
|
$
|
26,296,062
|
||||||
|
Cost of product revenue (exclusive of amortization expense shown below)
|
56,897,959
|
42,180,319
|
14,717,640
|
|||||||||
|
Gross loss
|
(2,338,201
|
)
|
(13,916,623
|
)
|
11,578,422
|
|||||||
|
Research and development expenses
|
2,917,072
|
4,893,549
|
(1,976,477
|
)
|
||||||||
|
Plasma center operating expenses
|
8,191,890
|
2,597,444
|
5,594,446
|
|||||||||
|
Amortization of intangibles
|
536,514
|
536,514
|
-
|
|||||||||
|
Selling, general and administrative expenses
|
31,198,880
|
25,750,458
|
5,448,422
|
|||||||||
|
Loss from operations
|
(45,182,557
|
)
|
(47,694,588
|
)
|
2,512,031
|
|||||||
|
Interest expense
|
(9,741,110
|
)
|
(8,875,597
|
)
|
(865,513
|
)
|
||||||
|
Other (expense) income, net
|
(74,531
|
)
|
229,411
|
(303,942
|
)
|
|||||||
|
Net loss
|
$
|
(54,998,198
|
)
|
$
|
(56,340,774
|
)
|
$
|
1,342,576
|
||||
|
Nine Months Ended September 30,
|
||||||||
|
2021
|
2020
|
|||||||
|
Net cash used in operating activities
|
$
|
(78,903,751
|
)
|
$
|
(69,783,522
|
)
|
||
|
Net cash used in investing activities
|
(9,835,404
|
)
|
(9,126,359
|
)
|
||||
|
Net cash provided by financing activities
|
67,228,573
|
111,832,791
|
||||||
|
Net change in cash and cash equivalents
|
(21,510,582
|
)
|
32,922,910
|
|||||
|
Cash and cash equivalents - beginning of period
|
55,921,152
|
26,752,135
|
||||||
|
Cash and cash equivalents - end of period
|
$
|
34,410,570
|
$
|
59,675,045
|
||||
|
Nine Months Ended September 30,
|
||||||||
|
2021
|
2020
|
|||||||
|
Net loss
|
$
|
(54,998,198
|
)
|
$
|
(56,340,774
|
)
|
||
|
Non-cash expenses, gains and losses
|
7,620,142
|
6,126,420
|
||||||
|
Changes in accounts receivable
|
(7,155,331
|
)
|
(2,864,617
|
)
|
||||
|
Changes in inventories
|
(32,587,273
|
)
|
(16,687,794
|
)
|
||||
|
Changes in prepaid expenses and other current assets
|
(2,812,580
|
)
|
(1,252,828
|
)
|
||||
|
Changes in accounts payable and accrued expenses
|
11,735,352
|
1,422,652
|
||||||
|
Other
|
(705,863
|
)
|
(186,581
|
)
|
||||
|
Cash used in operations
|
$
|
(78,903,751
|
)
|
$
|
(69,783,522
|
)
|
||
| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
| Item 4. |
Controls and Procedures.
|
| Item 1. |
Legal Proceedings.
|
| Item 1A. |
Risk Factors
|
|
|
• |
We have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.
|
|
|
• |
Our auditor’s report contains a going concern statement.
|
|
|
• |
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 inspection, 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.
|
|
|
• |
If the results of our clinical trials do not support our product candidate claims, completing the development of such product candidate may be significantly delayed or we may be forced to abandon development of such product candidate
altogether.
|
|
|
• |
If we do not obtain and maintain the necessary U.S. or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make it difficult for us to recover the
costs of researching and developing such product candidate.
|
|
|
• |
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 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 or test 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.
|
|
|
• |
The Perceptive Credit Facility is subject to acceleration in specified circumstances, which may result in Perceptive 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.
|
|
|
• |
expand commercialization and marketing efforts;
|
|
|
• |
implement additional internal systems, controls and infrastructure;
|
|
|
• |
hire additional personnel;
|
|
|
• |
expand and build out our plasma center network; and
|
|
|
• |
expand production capacity at the Boca Facility.
|
| • |
we may be unable to identify contract fill/finishers on acceptable terms or at all because the number of potential service providers is limited and the FDA must inspect and qualify any contract manufacturers for current cGMP compliance
as part of our marketing application;
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| • |
a new fill/finisher would have to be educated in, or develop substantially equivalent processes for, the production of our products and product candidates;
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| • |
the COVID-19 pandemic could adversely affect our contracted fill/finishers’ operations, supply chain or workforce;
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| • |
our contracted fill/finishers’ resources and level of expertise with plasma-derived biologics may be limited, and therefore they may require a significant amount of support from us in order to implement and maintain the infrastructure
and processes required to deliver our finished drug product;
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| • |
our third-party fill/finishers might be unable to timely provide finished drug product in sufficient quantity to meet our commercial needs;
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| • |
contract manufacturers may not be able to execute our inspection procedures and required tests appropriately;
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| • |
contract manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations, and we do not have control over
third-party providers’ compliance with these regulations;
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| • |
our third-party fill/finishers could breach or terminate their agreements with us; and
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| • |
our contract fill/finishers may have unacceptable or inconsistent drug product quality success rates and yields, and we have no direct control over our contract fill/finishers’ ability to maintain adequate quality control, quality
assurance and qualified personnel.
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• |
unforeseen safety issues;
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• |
determination of dosing issues;
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• |
lack of effectiveness during clinical trials;
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• |
slower than expected rates of patient recruitment;
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• |
inability to monitor patients adequately during or after treatment;
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• |
inability or unwillingness of medical investigators to follow our clinical protocols; and
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• |
temporary suspension resulting from the COVID-19 pandemic.
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• |
We may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and our CROs;
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• |
Regulators may require us to perform additional or unanticipated clinical trials to obtain approval or we may be subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval;
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• |
Our third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional
clinical trial site monitoring;
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• |
The cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by FDA upon the filing of a marketing
application;
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• |
The supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
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• |
We may not be able to achieve sufficient study enrollment, subjects may drop out or be withdrawn from out studies, we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical
trial sites;
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• |
There may be flaws in our clinical trial design that are not discoverable until the clinical trial has progressed;
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• |
The FDA or comparable foreign regulatory authorities may disagree with our intended indications or study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials, may find that a product
candidate’s benefits do not outweigh its safety risks, or may require that we conduct additional development or study work;
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• |
The FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or our contract manufacturer’s manufacturing facility for clinical and future commercial supplies;
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• |
We may need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected;
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• |
Global trade policies that may impact our or our manufacturers’ ability to obtain raw materials and/or finished product for commercialization;
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• |
FDA or comparable regulatory authorities may take longer than we anticipate to make decisions on our products or product candidates; and
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• |
We may not be able to demonstrate that a product or product candidate provides an advantage over current standards of care or current or future competitive therapies in development.
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• |
delay commercialization of, and our ability to derive revenues from, our product candidate;
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• |
impose costly procedures on us; and
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• |
diminish any competitive advantages that we may otherwise enjoy.
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|
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• | restrictions on such products or manufacturing processes; |
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|
• | restrictions on the labeling or marketing of a product; |
|
|
• | restrictions on product distribution or use; |
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• | clinical holds or termination of clinical trials; |
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• | requirements to conduct further post-marketing studies or clinical trials, implement risk mitigation strategies, or to issue corrective information; |
|
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• | warning letters or untitled letters; |
|
|
• | withdrawal of the products from the market; |
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• | refusal to approve pending applications or supplements to approved applications that we submit; |
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|
• | recall of products; |
|
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• | restrictions on coverage by third-party payers; |
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|
• | fines, restitution or disgorgement of profits or revenues; |
|
|
• | suspension or withdrawal of marketing approvals; |
|
|
• | refusal to permit the import or export of products; |
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|
• | FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from healthcare programs, consent decrees, or corporate integrity agreements; |
|
|
• | product seizure or detention; or |
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|
• | injunctions or the imposition of civil or criminal penalties. |
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|
• |
our ability to sell our products at competitive prices;
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• |
our ability to maintain features and quality standards for our products sufficient to meet the expectations of our customers;
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|
• |
our ability to produce and deliver a sufficient quantity of our products in a timely manner to meet our customers’ requirements; and
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• |
the impact of the ongoing COVID-19 pandemic and government responses thereto on our customers and their businesses, operations and financial condition.
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• |
perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;
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• |
cost-effectiveness of our products relative to competing products;
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|
• |
availability of reimbursement for our products from government or other healthcare payers; and
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|
• |
the effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
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• |
sales or potential sales of substantial amounts of our common stock;
|
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|
• |
uncertainties in the equity markets related to the effects of the COVID-19 pandemic;
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|
• |
delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;
|
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|
• |
delay in a decision by federal, state or local business regulatory authority;
|
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|
• |
the timing of acceptance, third-party reimbursement and sales of BIVIGAM and ASCENIV;
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|
• |
announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;
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|
• |
developments concerning our licensors or third-party vendors;
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|
• |
litigation and other developments relating to our patents or other proprietary rights or those of our competitors;
|
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|
• |
conditions in the pharmaceutical or biotechnology industries;
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|
• |
governmental regulation and legislation;
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|
• |
overall market volatility;
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|
• |
variations in our anticipated or actual operating results; and
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|
• |
change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.
|
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|
• |
the inability of stockholders to call special meetings;
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|
• |
classification of our Board and limitation on filling of vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire control of our Company; and
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|
• |
authorization of the issuance of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board, without any need for action by stockholders.
|
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds.
|
| Item 3. |
Defaults Upon Senior Securities.
|
| Item 4. |
Mine Safety Disclosures.
|
| Item 5. |
Other Information.
|
|
ADMA Biologics, Inc.
|
||||
|
Date:
|
November 10, 2021 | By: | /s/ Adam S. Grossman | |
|
Name:
|
Adam S. Grossman
|
|||
|
Title:
|
President and Chief Executive Officer
|
|||
|
Date:
|
November 10, 2021 | By: | /s/ Brian Lenz | |
|
Name:
|
Brian Lenz
|
|||
|
Title:
|
Executive Vice President and Chief Financial Officer
|
|||
|
Exhibit Number
|
Description
|
|
Distribution Agreement, dated September 3, 2021, by and between ADMA Biologics, Inc. and Raymond James & Associates, Inc. (incorporated by reference to Exhibit 1.1 of the Company’s Current Report on
Form 8-K filed with the SEC on September 3, 2021).
|
|
|
Form of Retention Bonus Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 1, 2021).
|
|
|
Amendment to Employment Agreement, dated as of September 29, 2021, by and between the Company and Adam Grossman (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed
with the SEC on October 1, 2021).
|
|
|
Amendment to Employment Agreement, dated as of September 29, 2021, by and between the Company and Brian Lenz (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with
the SEC on October 1, 2021).
|
|
|
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
101*
|
The following materials from ADMA Biologics, Inc.’s Form 10-Q for the quarter ended September 30, 2021, formatted in Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets
as of September 30, 2021 (Unaudited) and December 31, 2020, (ii) Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2021 and 2020, (iii) Condensed Consolidated Statements of
Changes in Stockholders’ Equity (Unaudited) for the three and nine months ended September 30, 2021 and 2020, (iv) Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2021 and 2020, and (v)
Notes to (Unaudited) Condensed Consolidated Financial Statements.
|
|
104
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|