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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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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PART I FINANCIAL INFORMATION
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Item 1.
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Financial Statements
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1
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2
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3
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4
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5
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|||
Item 2.
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22
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Item 3.
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36
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Item 4.
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36 | ||
38
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Item 1.
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38
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||
Item 1A.
|
38
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||
Item 2.
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69
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Item 3.
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69
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Item 4.
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69
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Item 5.
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69
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Item 6.
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69
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70
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• |
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;
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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, 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;
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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 Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease
(“PIDD”) or Inborn Errors of Immunity, 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 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;
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• |
our estimates regarding revenues, expenses, capital requirements, timing to profitability and positive cash flows 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 and other potential pandemics 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 other potential pandemics; and
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• |
future domestic and global economic conditions including, but not limited to, supply chain constraints, inflationary pressures or performance or geopolitical conditions, including the continuing conflict in Europe or the evolving
conflict in the Middle East and surrounding areas.
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Item 1. |
Financial Statements.
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September 30, | December 31, | |||||||
2023
|
2022
|
|||||||
ASSETS |
(Unaudited)
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|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Accounts receivable, net
|
|
|
||||||
Inventories
|
|
|
||||||
Prepaid expenses and other current assets
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|
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||||||
Total current assets
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|
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||||||
Property and equipment, net
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|
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||||||
Intangible assets, net
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||||||
Goodwill
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|
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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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$
|
|
$
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses and other current liabilities
|
|
|
||||||
Current portion of deferred revenue
|
|
|
||||||
Current portion of lease obligations
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|
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||||||
Total current liabilities
|
|
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||||||
Senior notes payable, net of discount
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|
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||||||
Deferred revenue, net of current portion
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||||||
End of term fee |
||||||||
Lease obligations, net of current portion
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|
||||||
Other non-current liabilities
|
|
|
||||||
TOTAL LIABILITIES
|
|
|
||||||
COMMITMENTS AND CONTINGENCIES
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||||||||
STOCKHOLDERS’ EQUITY
|
||||||||
Preferred Stock, $
|
|
|
||||||
Common Stock - voting, $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
TOTAL STOCKHOLDERS’ EQUITY
|
|
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
|
$
|
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
REVENUES
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Cost of product revenue
|
||||||||||||||||
Gross profit
|
||||||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
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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|
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|
||||||||||||
INCOME (LOSS) FROM OPERATIONS
|
|
(
|
)
|
|
(
|
)
|
||||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
Interest income
|
|
|
|
|
||||||||||||
Interest expense
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Loss on extinguishment of debt | ( |
) | ||||||||||||||
Other expense
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Other expense, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
NET INCOME (LOSS)
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
BASIC INCOME (LOSS) PER COMMON SHARE
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
DILUTED INCOME (LOSS) PER COMMON SHARE |
$ |
$ |
( |
) | $ |
( |
) | $ |
( |
) | ||||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||||||||||
Basic
|
|
|
|
|
||||||||||||
Diluted
|
Additional | Total | |||||||||||||||||||
Common Stock
|
Paid-in
|
Accumulated
|
Stockholders’
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance at December 31, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock-based compensation
|
-
|
|
|
|
|
|||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes
|
|
|
(
|
)
|
|
(
|
)
|
|||||||||||||
Exercise of stock options |
||||||||||||||||||||
Net loss
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at March 31, 2023
|
|
|
|
(
|
)
|
|
||||||||||||||
Stock-based compensation
|
-
|
|
|
|
|
|||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes
|
( |
) | ( |
) | ||||||||||||||||
Warrants issued in connection with note payable |
- |
|||||||||||||||||||
Cashless exercise of warrants |
( |
) | ||||||||||||||||||
Exercise of stock options |
||||||||||||||||||||
Net loss
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at June 30, 2023 | ( |
) | ||||||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes |
( |
) | ( |
) | ||||||||||||||||
Exercise of stock options |
||||||||||||||||||||
Stock-based compensation |
- | |||||||||||||||||||
Net income |
- | |||||||||||||||||||
Balance at September 30, 2023 |
$ |
$ |
$ |
( |
) | $ |
Additional | Total | |||||||||||||||||||
Common Stock
|
Paid-in
|
Accumulated
|
Stockholders’
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Warrants issued in connection with notes payable
|
-
|
|
|
|
||||||||||||||||
Stock-based compensation |
- | |||||||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes |
( |
) | ( |
) | ||||||||||||||||
Net loss
|
- | ( |
) | ( |
) | |||||||||||||||
Balance at March 31, 2022
|
|
|
|
(
|
)
|
|
||||||||||||||
Stock-based compensation
|
-
|
|
|
|
|
|||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes |
||||||||||||||||||||
Net loss
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at June 30, 2022 | ( |
) | ||||||||||||||||||
Stock-based compensation |
- | |||||||||||||||||||
Vesting of Restricted Stock Units, net of shares withheld for taxes |
( |
) | ( |
) | ||||||||||||||||
Net loss |
- | ( |
) | ( |
) | |||||||||||||||
Balance at September 30, 2022 |
$ |
$ |
$ |
( |
) | $ |
Nine Months Ended September 30,
|
||||||||
2023
|
2022
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | ( |
) |
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Loss on disposal of fixed assets
|
|
|
||||||
Interest paid in kind | ||||||||
Stock-based compensation
|
|
|
||||||
Amortization of debt discount
|
|
|
||||||
Loss on extinguishment of debt
|
||||||||
Amortization of license revenue
|
(
|
)
|
(
|
)
|
||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(
|
)
|
|
|||||
Inventories
|
|
(
|
)
|
|||||
Prepaid expenses and other current assets
|
(
|
)
|
(
|
)
|
||||
Deposits and other assets
|
(
|
)
|
|
|||||
Accounts payable
|
(
|
)
|
|
|||||
Accrued expenses
|
|
|
||||||
Other current and non-current liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Principal payments on notes payable
|
( |
) | ||||||
Payment of debt refinancing fees
|
|
(
|
)
|
|||||
Proceeds from issuance of note payable
|
||||||||
Taxes paid on vested Restricted Stock Units
|
(
|
)
|
(
|
)
|
||||
Payments on finance lease obligations
|
(
|
)
|
(
|
)
|
||||
Net proceeds from the exercise of stock options | ||||||||
Payment of deferred financing fees
|
( |
) | ||||||
Net cash provided by financing activities
|
|
|
||||||
Net decrease 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
|
Net income available to common stockholders (numerator)
|
$
|
|
||
Weighted-average number of common shares (denominator)
|
|
|||
Basic earnings per common shares
|
$
|
|
||
|
||||
Weighted-average number of common shares
|
|
|||
Potential shares of common stock arising from outstanding stock options, warrants and unvested RSUs
|
|
|||
Total shares - diluted (denominator)
|
|
|||
Diluted earnings per common share
|
$
|
|
For the Nine Months Ended September 30,
|
||||||||
2023
|
2022
|
|||||||
Stock options
|
|
|
||||||
Restricted Stock Units
|
|
|
||||||
Warrants
|
|
|
||||||
|
|
3. |
INVENTORIES
|
September 30,
2023
|
December 31,
2022
|
|||||||
Raw materials
|
$
|
|
$
|
|
||||
Work-in-process
|
|
|
||||||
Finished goods
|
|
|
||||||
Total inventories
|
$
|
|
$
|
|
4. |
INTANGIBLE ASSETS
|
September 30, 2023
|
December 31, 2022
|
|||||||||||||||||||||||
Accumulated | Accumulated | |||||||||||||||||||||||
Cost
|
Amortization
|
Net
|
Cost
|
Amortization
|
Net
|
|||||||||||||||||||
Trademark and other intangible rights related to Nabi-HB
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
Rights to intermediates
|
|
|
|
|
|
|
||||||||||||||||||
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Remainder of 2023
|
$
|
|
||
2024
|
|
5. |
PROPERTY AND EQUIPMENT
|
September 30, 2023
|
December 31, 2022
|
|||||||
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, plant and equipment, net
|
$
|
|
$
|
|
6. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
|
September 30, 2023
|
December 31, 2022
|
|||||||
Accrued rebates
|
$
|
|
$
|
|
||||
Accrued distribution fees
|
|
|
||||||
Accrued incentives
|
|
|
||||||
Accrued testing
|
|
|
||||||
Accrued payroll and other compensation
|
|
|
||||||
Other
|
|
|
||||||
Total accrued expenses and other current liabilities
|
$
|
|
$
|
|
7. |
DEBT
|
September 30, 2023
|
December 31, 2022
|
|||||||
Notes payable
|
$
|
|
$
|
|
||||
Less:
|
||||||||
Debt discount
|
(
|
)
|
(
|
)
|
||||
Senior notes payable
|
$
|
|
$
|
|
8. |
STOCKHOLDERS’ EQUITY
|
Nine Months Ended September 30,
|
||||||
2023
|
2022
|
|||||
Expected term
|
|
|
||||
Volatility
|
68%
|
|
68%
|
|
||
Dividend yield
|
0.0
|
0.0
|
||||
Risk-free interest rate
|
4.20-4.24%
|
|
1.72-1.73%
|
|
Shares
|
Weighted
Average
Exercise Price
|
|||||||
Options outstanding, vested and expected to vest at December 31, 2022
|
|
$
|
|
|||||
Forfeited
|
(
|
)
|
$
|
|
||||
Expired
|
(
|
)
|
$
|
|
||||
Granted
|
|
$
|
|
|||||
Exercised | ( |
) | $ | |||||
Options outstanding, vested and expected to vest at September 30, 2023
|
|
$
|
|
|||||
Options exercisable
|
|