Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Mar. 28, 2014 | Oct. 17, 2013 | |
Document And Entity Information | ' | ' | ' |
Entity Registrant Name | 'ADMA BIOLOGICS, INC. | ' | ' |
Entity Central Index Key | '0001368514 | ' | ' |
Document Type | '10-K | ' | ' |
Document Period End Date | 31-Dec-13 | ' | ' |
Amendment Flag | 'false | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' |
Is Entity a Well-known Seasoned Issuer? | 'No | ' | ' |
Is Entity a Voluntary Filer? | 'No | ' | ' |
Is Entity's Reporting Status Current? | 'Yes | ' | ' |
Entity Filer Category | 'Smaller Reporting Company | ' | ' |
Entity Public Float | ' | ' | $26,500,000 |
Entity Common Stock, Shares Outstanding | ' | 9,291,823 | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Document Fiscal Year Focus | '2013 | ' | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Current Assets | ' | ' |
Cash and cash equivalents | $26,149,477 | $12,535,672 |
Short-Term Investments | 2,935,184 | 0 |
Accounts Receivable | 0 | 39,112 |
Inventories | 1,669,058 | 1,265,593 |
Prepaid Expenses | 298,730 | 107,761 |
Total Current Assets | 31,052,449 | 13,948,138 |
Property and Equipment at cost, Net | 765,299 | 779,297 |
Other Assets | ' | ' |
Deferred Financing Costs | 149,618 | 363,403 |
Restricted Cash | 0 | 452,004 |
Deposits | 12,577 | 12,577 |
Total Other Assets | 162,195 | 827,984 |
TOTAL ASSETS | 31,979,943 | 15,555,419 |
Current Liabilities | ' | ' |
Accounts Payable | 2,709,489 | 1,058,671 |
Accrued expenses | 823,550 | 747,079 |
Accrued Interest | 36,597 | 0 |
Current Portion of Deferred Revenue | 75,556 | 0 |
Current Portion of Leasehold Improvement Loan | 12,654 | 11,569 |
Total Current Liabilities | 3,657,846 | 1,817,319 |
Notes Payable, Net of Debt Discount | 4,865,228 | 3,773,524 |
Warrant Liability | 0 | 229,345 |
End of Term Liability, Note Payable | 132,500 | 106,000 |
Deferred Revenue | 1,580,370 | 0 |
Deferred Rent Liability | 105,404 | 127,595 |
Leasehold Improvement Loan | 65,236 | 77,890 |
TOTAL LIABILITIES | 10,406,584 | 6,131,673 |
STOCKHOLDERS' (DEFICIENCY) EQUITY | ' | ' |
Common Stock $.0001 par value 75,000,000 shares authorized, 9,291,823 and 5,871,002 shares issued and outstanding at December 31, 2013 and 2012, respectively | 929 | 587 |
Additional paid-in capital | 74,209,004 | 46,532,487 |
Accumulated Deficit | -52,636,574 | -37,109,328 |
TOTAL STOCKHOLDERS' EQUITY | 21,573,359 | 9,423,746 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $31,979,943 | $15,555,419 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Stockholders Equity | ' | ' |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, issued | 9,291,823 | 5,871,002 |
Common stock, outstanding | 9,291,823 | 5,871,002 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Condensed Consolidated Statements Of Operations | ' | ' |
Product revenue | $3,023,503 | $1,118,118 |
License revenue | 44,074 | 0 |
Total Revenues | 3,067,577 | 1,118,118 |
OPERATING EXPENSES | ' | ' |
Cost of product revenue | 2,023,441 | 669,056 |
Research and development | 9,303,077 | 3,469,078 |
Plasma center | 2,418,156 | 1,746,864 |
General and administrative expenses | 4,365,334 | 3,142,289 |
TOTAL OPERATING EXPENSES | 18,110,008 | 9,027,287 |
LOSS FROM OPERATIONS | -15,042,431 | -7,909,169 |
OTHER INCOME (EXPENSE): | ' | ' |
Interest income | 7,623 | 20,924 |
Interest expense | -618,225 | -30,683 |
Change in fair value of stock warrants | 43,290 | 0 |
Other income | 82,497 | 0 |
TOTAL OTHER INCOME (EXPENSE) | -484,815 | -9,759 |
LOSS BEFORE INCOME TAXES | -15,527,246 | -7,918,928 |
State income tax benefit | 0 | 617,615 |
NET LOSS | ($15,527,246) | ($7,301,313) |
NET LOSS PER COMMON SHARE - BASIC AND DILUTED | ($2.38) | ($1.39) |
WEIGHTED AVERAGE SHARES OUTSTANDING, Basic and Diluted | 6,531,029 | 5,265,771 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (USD $) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning Balance, Amount at Dec. 31, 2011 | $8,221,678 | $518,908 | ' | ' | ' |
Beginning Balance, Shares at Dec. 31, 2011 | 8,222 | 519 | 30,185,090 | -29,808,015 | 385,816 |
Conversion of preferred shares and accumulated dividends, Amount | -8,222 | 3,003 | 5,219 | ' | ' |
Conversion of preferred shares and accumulated dividends, Shares | -8,221,678 | 3,002,988 | ' | ' | ' |
Conversion of notes payable and accrued interest into common stock in private placement, Amount | ' | 35 | 262,705 | ' | 262,740 |
Conversion of notes payable and accrued interest into common stock in private placement, Shares | ' | 34,759 | ' | ' | ' |
Common stock sold in private placement, net of expenses, Amount | ' | 2,287 | 15,597,429 | ' | 15,599,716 |
Common stock sold in private placement, net of expenses, Shares | ' | 2,286,964 | ' | ' | ' |
Common stock retained by stockholders of shell company as part of reverse merger, Amount | ' | 67 | -67 | ' | ' |
Common stock retained by stockholders of shell company as part of reverse merger, Shares | ' | 67,352 | ' | ' | ' |
Effects of change in par value from $0.001 to $0.0001 as a result of the reverse merger, Amount | ' | -5,320 | 5,320 | ' | ' |
Repurchase of common stock from placement agent, Amount | ' | -4 | -149,996 | ' | -150,000 |
Repurchase of common stock from placement agent, Shares | ' | -39,969 | ' | ' | ' |
Elimination of warrant liability | ' | ' | ' | ' | 0 |
Stock-based compensation | ' | ' | 626,787 | ' | 626,787 |
Net loss | ' | ' | ' | -7,301,313 | -7,301,313 |
Ending Balance, Amount at Dec. 31, 2012 | ' | 587 | 46,532,487 | -37,109,328 | 9,423,746 |
Ending Balance, Shares at Dec. 31, 2012 | ' | 5,871,002 | ' | ' | ' |
Proceeds received from Initial Public Offering, net of equity issuance costs, Amount | ' | 342 | 26,602,167 | ' | 26,602,509 |
Proceeds received from Initial Public Offering, net of equity issuance costs, Shares | ' | 3,420,821 | ' | ' | ' |
Elimination of warrant liability | ' | ' | 186,055 | ' | 186,055 |
Stock-based compensation | ' | ' | 888,295 | ' | 888,295 |
Net loss | ' | ' | ' | -15,527,246 | -15,527,246 |
Ending Balance, Amount at Dec. 31, 2013 | ' | $929 | $74,209,004 | ($52,636,574) | $21,573,359 |
Ending Balance, Shares at Dec. 31, 2013 | ' | 9,291,823 | ' | ' | ' |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' |
Net Loss | ($15,527,246) | ($7,301,313) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 210,633 | 182,089 |
Stock based compensation | 888,295 | 626,787 |
Warrant liability | -43,290 | 0 |
Amortization of debt discount | 91,704 | 2,869 |
Amortization of deferred financing costs | 99,238 | 2,644 |
Non-cash interest expense related to notes payable | 0 | 1,959 |
Loss on sale of equipment | 0 | 18,399 |
Amortization of license revenue | -44,074 | 0 |
Changes in operating assets and liabilities | ' | ' |
Accounts receivable | 39,112 | -39,112 |
Inventories | -403,465 | -118,248 |
Prepaid Expenses | -190,969 | -48,517 |
Other assets | 593,051 | -115,041 |
Accounts payable | 1,608,980 | -244,743 |
Accrued expenses | 76,471 | 150,622 |
Accrued interest | 36,597 | 0 |
Deferred revenue | 1,700,000 | 0 |
Deferred rent liability | -22,191 | -22,190 |
Net cash used in operating activities | -10,887,154 | -6,903,795 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' |
Short-term investments | -2,935,184 | 0 |
Purchase of property and equipment | -196,635 | -118,853 |
Net cash used in investing activities | -3,131,819 | -118,853 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' |
Net proceeds from issuance of common stock | 27,030,820 | 17,287,288 |
Proceeds from Hercules note payable | 1,000,000 | 3,906,000 |
Payment of equity issuance costs | -386,473 | -1,338,009 |
Debt issuance costs | ' | -25,000 |
Repurchase of common stock | ' | -150,000 |
Repayments on notes payable | ' | -200,000 |
Payments of leasehold improvement loan | -11,569 | -9,730 |
Net cash provided by financing activities | 27,632,778 | 19,470,549 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 13,613,805 | 12,447,901 |
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD | 12,535,672 | 87,771 |
CASH AND CASH EQUIVALENTS - END OF PERIOD | 26,149,477 | 12,535,672 |
SUPPLEMENTAL INFORMATION: | ' | ' |
Cash paid for interest | 382,736 | 1,085 |
Supplemental Disclosure of Noncash Financing Activities: | ' | ' |
Conversion of notes payable and accrued interest into common stock | 0 | 262,740 |
Reclassification of equity issuance costs to additional paid-in capital | 428,311 | 0 |
Accrued equity issuance costs | 41,838 | 69,533 |
End of term liability for Hercules note payable | 26,500 | 106,000 |
Warrants issued in connection with note payable | 0 | 229,345 |
Elimination of warrant liability | 186,055 | 0 |
Stock retained by stockholders of shell company | $0 | $67 |
1_ORGANIZATION_AND_BUSINESS
1. ORGANIZATION AND BUSINESS | 12 Months Ended |
Dec. 31, 2013 | |
Accounting Policies [Abstract] | ' |
1. ORGANIZATION AND BUSINESS | ' |
ADMA Biologics, Inc. (“ADMA” or the “Company”) is a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-compromised for medical reasons. ADMA also operates ADMA BioCenters Georgia, Inc., (“ADMA BioCenters”) of Norcross, Georgia, a source plasma collection facility licensed by the U.S. Food and Drug Administration (“FDA”) and certified by the German Health Authority (“GHA”), which provides ADMA with a portion of its blood plasma for the manufacture of RI-002, ADMA’s lead product candidate. | |
The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. The Company has needed to raise capital from the sales of its equity and debt securities to sustain operations. In October 2013, the Company completed an Initial Public Offering (“IPO”) to raise gross proceeds of $29.1 million, and in February 2012, the Company completed a private placement to raise gross proceeds of $17.3 million (see Note 6), and during December 2012 and February 2014, the Company borrowed a total of $10 million from Hercules Technology Growth Capital, Inc. (“Hercules”) (see Note 5). | |
Based upon the Company’s projected revenue and expenditures for 2014, management currently believes the Company’s existing cash and cash equivalents, short term investments along with an additional $5.0 million from Hercules, which will be made available upon the Company successfully meeting the clinical endpoints of a Phase III clinical study of RI-002 as a treatment for Primary Immunodeficiency Diseases in a manner that supports a Biologic License Application filing from our existing Amended Loan and Security Agreement with Hercules, will be sufficient to enable it to fund its operating expenses, research and development expenses and capital expenditures into 2016. Because the Company does not anticipate receiving FDA approval for RI-002 until, at the earliest, the first half of 2016 if at all, and would therefore not be able to generate revenues from the commercialization of RI-002 until after that date, if the Company’s assumptions underlying its estimated revenues and expenses prove to be wrong, it may have to raise additional capital sooner than anticipated. There can be no assurance that such funds, if available at all, can be obtained on terms acceptable to the Company. Because of numerous risks and uncertainties associated with the research, development and future commercialization of the Company’s product candidate, it is unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with its anticipated clinical trials and development activities. Its current estimates may be subject to change as circumstances regarding requirements further develop. | |
ADMA’s long term liquidity will be dependent upon on its ability to raise additional capital, to fund its research and development and commercial programs and meet its obligations on a timely basis. If ADMA is unable to successfully raise sufficient additional capital, it will likely not have sufficient cash flow and liquidity to fund its business operations, forcing ADMA to curtail activities and, ultimately, potentially cease operations. Even if ADMA is able to raise additional capital, such financings may only be available on unattractive terms, resulting in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of its common stock may decline. | |
There can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements. | |
ADMA’s primary focus since 2004 has been conducting research and development of human plasma-derived products for the treatment of specific disease states. The plasma collection center in Georgia was established in 2008 as a complementary business operation. The Georgia facility received its Food and Drug Administration or FDA license in August 2011. Under FDA license, ADMA BioCenters can collect normal source plasma and high-titer RSV plasma. The Company sells a portion of the collected normal source plasma to buyers in the open “spot” market. The Company also plans to use the high-titer Respiratory Syncytial Virus (“RSV”) plasma collected by ADMA BioCenters in the manufacturing of RI-002. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Accounting Policies [Abstract] | ' | ||||
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||||
The following comprises the Company’s significant accounting policies: | |||||
Basis of presentation | |||||
The accompanying consolidated financial statements include the accounts of ADMA Biologics, Inc. and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. | |||||
Cash and cash equivalents | |||||
The Company considers all highly-liquid instruments purchased with a maturity of three months or less to be cash equivalents. The Company purchases certificates of deposits with maturity schedules of three, six, nine and twelve months. Instruments with maturity greater than three months but less than twelve months are included in short term investments. As of December 31, 2012, the Company had $0.5 million in restricted cash associated with a letter of credit related to our landlord agreement for our Georgia ADMA BioCenters facility. As of December 31, 2013, none of our cash was restricted and the letter of credit expired. | |||||
The Company regularly maintains cash and short term investments at third-party financial institutions in excess of the Federal Deposit Insurance Corporation, or FDIC, insurance limit. While the Company monitors the daily cash balances in the operating accounts and adjusts the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our business, if one or more of the financial institutions with which the Company has deposits fails or is subject to other adverse conditions in the financial or credit markets. To date, the Company has not experienced a loss or lack of access to its invested cash or cash equivalents; however, the Company cannot provide assurance that access to its invested cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets. | |||||
Inventories | |||||
Plasma inventories (both plasma intended for resale and plasma intended for internal use in our research and development activities) are carried at the lower of cost or market value determined on the first-in, first-out method. Once the research and development plasma is processed to a finished good for ongoing trials it is then expensed to research and development. Inventory at December 31, 2013 and 2012 consists of raw materials. Inventory also includes plasma collected at the Company’s FDA licensed plasma collection center. | |||||
Revenue recognition | |||||
Revenue from the sale of human plasma collected at the Company’s FDA licensed plasma collection center and plasma-derived medicinal products is recognized at the time of transfer of title and risk of loss to the customer, which occurs at the time of shipment. Revenue is recognized at the time of delivery if the Company retains the risk of loss during shipment. The Company’s revenues are substantially attributed to one customer. Revenue from license fees and research and development services rendered are recognized as revenue when the performance obligations under the terms of the license agreement have been completed. Deferred revenue of $1.7 million was recorded in 2013 as a result of certain research and development services to be provided in accordance with a license agreement and is recognized over the term of the license. Deferred revenue is amortized into income for a period of approximately 20 years, the term of the license agreement. | |||||
Concentration of Significant Customers and Accounts Receivable | |||||
As of December 31, 2013 and 2012, the Company’s customers, revenues and trade receivable balances were substantially attributed to one customer. | |||||
Research and development costs | |||||
The Company expenses all research and development costs as incurred including plasma and equipment for which there is no alternative future use. Such expenses include licensing fees and costs associated with planning and conducting clinical trials. | |||||
Use of estimates | |||||
The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of inventory, assumptions used in the fair value of stock-based compensation, and the allowance for the valuation of future tax benefits. | |||||
Concentration of credit risk | |||||
Financial instruments which potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and short-term investments. | |||||
Property and equipment | |||||
Fixed assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s estimated useful life, which is five to ten years. Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives. | |||||
Income taxes | |||||
The Company recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax liabilities and assets are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred income tax assets if it is more likely than not that these deferred income tax assets will not be realized. | |||||
The Company has no unrecognized tax benefits at December 31, 2013 and 2012. The Company’s U.S. Federal and state income tax returns prior to fiscal year 2010 are closed and management continually evaluates expiring statutes of limitations, audits, proposed settlements, changes in tax law and new authoritative rulings. | |||||
The Company will recognize interest and penalties associated with tax matters as income tax expense. | |||||
Earnings (Loss) Per Share | |||||
Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing net loss applicable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of common stock and dilutive common stock outstanding during the period. No potentially dilutive securities are included in the computation of any diluted per share amounts as the Company reported a net loss for all periods presented. Potentially dilutive securities that would be issued upon the exercise of outstanding warrants and stock options were 1.0 million at December 31, 2013 and 0.7 million at December 31, 2012. | |||||
Stock-based compensation | |||||
The Company follows recognized accounting guidance which requires all stock-based payments, including grants of stock options, to be recognized in the statement of operations as compensation expense, based on their fair values on the grant date. The estimated fair value of options granted under the Company’s 2007 Employee Stock Option Plan (the “Plan”) are recognized as compensation expense over the option-service period. | |||||
During the years ended December 31, 2013 and 2012, the Company recorded stock-based compensation expense to employees of $888,295 and $626,787, respectively. There were 84,134 and 506,559 options granted to employees and members of the Board of Directors for the years ended December 31, 2013 and 2012, respectively. For the year ended December 31, 2013, 6,350 options were forfeited due to an employee termination. | |||||
The fair value of employee options granted was determined on the date of grant using the Black-Scholes model. The Black-Scholes option valuation model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate. Because there is no public market for the Company’s stock and very little historical experience with the Company’s stock options, small similar publicly traded companies were used for comparison and expectations as to assumptions required for fair value computation using the Black-Scholes methodology. Guidance for stock-based compensation requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company currently estimates there will be no forfeitures of options. Due to the Company’s limited history, the Company uses the simplified method, to determine the expected life of the option grants, which is the average between vesting terms and contractual terms. | |||||
The Company records compensation expense associated with stock options and other forms of equity compensation using the Black-Scholes option-pricing model and the following assumptions: | |||||
Year Ended | |||||
31-Dec-13 | |||||
Expected term | 6.3 years | ||||
Volatility | 63% | ||||
Dividend yield | 0 | ||||
Risk-free interest rate | 1.24-2.25% | ||||
Fair value of financial instruments | |||||
The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, short-term investments, accounts payable, and notes payable are shown at cost which approximates fair value due to the short-term nature of these instruments. The carrying value of the long-term note payable bears interest at a rate per annum equal to the greater of (i) 8.75% and (ii) the sum of (a) 8.75% plus (b) the Prime Rate (as reported in The Wall Street Journal) minus (c) 5.75%, which approximates its fair value as of December 31, 2013 and also approximates the February 2014 terms of the amended loan agreement. | |||||
3_PROPERTY_AND_EQUIPMENT
3. PROPERTY AND EQUIPMENT | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
3. PROPERTY AND EQUIPMENT | ' | ||||||||
Property and equipment consist of the following at December 31, | 2013 | 2012 | |||||||
Lab and office equipment | $ | 674,885 | $ | 523,300 | |||||
Computer software | 184,077 | 141,277 | |||||||
Leasehold improvements | 942,353 | 940,103 | |||||||
1,801,315 | 1,604,680 | ||||||||
Less: Accumulated depreciation and amortization | (1,036,016 | ) | (825,383 | ) | |||||
$ | 765,299 | $ | 779,297 | ||||||
The Company recorded depreciation and amortization expense of $210,633 and $182,089 for the years ended December 31, 2013 and 2012, respectively. The Company recorded a loss on disposal of equipment of $18,399 for the year ended December 31, 2012. |
4_LEASEHOLD_IMPROVEMENT_LOAN
4. LEASEHOLD IMPROVEMENT LOAN | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Notes to Financial Statements | ' | ||||
4. LEASEHOLD IMPROVEMENT LOAN | ' | ||||
In connection with the lease of commercial real estate by the Company’s wholly-owned subsidiary for the operation of the plasma collection center, the Company borrowed $125,980 from the lessor to pay for leasehold improvement costs in excess of the allowance provided for in the lease agreement. The loan bears interest at 9% and is payable in 120 monthly installments of $1,596 maturing December 31, 2018. Principal maturities under the loan are as follows: | |||||
2014 | $ | 12,654 | |||
2015 | 13,841 | ||||
2016 | 15,139 | ||||
2017 | 16,559 | ||||
2018 | 18,113 | ||||
2019 | 1,584 | ||||
$ | 77,890 | ||||
5_DEBT
5. DEBT | 12 Months Ended |
Dec. 31, 2013 | |
Debt Disclosure [Abstract] | ' |
5. DEBT | ' |
Hercules Debt Agreement | |
On December 21, 2012, the Company and its subsidiaries entered into a Loan and Security Agreement, or the Loan Agreement, with Hercules Technology Growth Capital, Inc., or Hercules. Under the Loan Agreement, the Company borrowed $5.0 million consisting of $4.0 million on the closing date and an additional $1.0 million upon enrolling its first patient in its pivotal (Phase III) clinical study of its lead product candidate RI-002. On February 24, 2014, the Company entered into the First Amendment to the Loan Agreement, or Loan Amendment, under which the Company may borrow up to a maximum of $15.0 million. the Company borrowed $10.0 million on the closing date ($5.0 million of which was used to refinance existing debt with Hercules) and an additional $5.0 million will be made available upon the Company successfully meeting the clinical endpoints of a Phase III clinical study of RI-002 as a treatment for Primary Immunodeficiency Diseases in an manner that supports a Biologic License Application filing. The loan bears interest at a rate per annum equal to the greater of (i) 8.75% and (ii) the sum of (a) 8.75% plus (b) the Prime Rate (as reported in The Wall Street Journal) minus (c) 5.75%. Payment-in-kind interest accrues on the outstanding principal balance of the loan compounded monthly at 1.95% per annum and such accrued and unpaid interest is added to the principal balance of the loan on the first day of each month beginning on the month after the closing. The principal will be repaid over 27 months beginning no later than April 1, 2015 (unless extended to October 1, 2015 upon the Company meeting certain eligibility criteria for the final tranche), unless accelerated as a result of certain events of default. A backend fee equal to $132,000 is due the earliest of April 1, 2016, the prepayment date and the date that the secured obligations become due and payable. In addition, a first amendment commitment fee and a facility fee in the amount of $15,000 and $135,000, respectively, were paid at closing. In the event the Company elects to prepay the loan, the Company is obligated to pay a prepayment charge corresponding to a percentage of the principal amount of the loan, with such percentage being: 2.5% if prepayment occurs in the first year, 1.5% if prepayment occurs in the second year and 0.5% if prepayment occurs after the second year but prior to the final day of the term. The loan matures no later than January 1, 2018. | |
The loan is secured by the Company's assets, except for its intellectual property (which is subject to a negative pledge). Interest is due and payable on the 1st of every month and at the termination date, unless accelerated as a result of an event of default. | |
The Loan Agreement contains customary representations, warranties and covenants, including limitations on incurring indebtedness, engaging in mergers or acquisitions and making investments, distributions or transfers. The representations, warranties and covenants contained in the Loan Agreement were made only for purposes of such agreement and as of a specific date or specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Loan Agreement. | |
Events of default under the agreement include, but are not limited to: (i) insolvency, liquidation, bankruptcy or similar events; (ii) failure to pay any debts due under the Loan Agreement or other loan documents on a timely basis; (iii) failure to observe any covenant or secured obligation under the Loan Agreement or other loan documents, which failure, in most cases, is not cured within 10 days of written notice by lender; (iv) occurrence of any default under any other agreement between us and the lender, which is not cured within 10 days; (v) occurrence of an event that could reasonably be expected to have a material adverse effect; (vi) material misrepresentations; (vii) occurrence of any default under any other agreement involving indebtedness in excess of $50,000 or the occurrence of a default under any agreement that could reasonably be expected to have a material adverse effect; and (viii) certain money judgments are entered against us or a certain portion of our assets are attached or seized. Remedies for events of default include acceleration of amounts owing under the Loan Agreement and taking immediate possession of, and selling, any collateral securing the loan. | |
In connection with the original Loan Agreement, the Company issued to Hercules a warrant to purchase 31,750 shares of common stock with an exercise price of $7.56, and under the amended Loan Agreement, the Company issued to Hercules a warrant to purchase 34,800 shares of its common stock (and a warrant for an additional 23,200 shares of common stock if the Company borrows an additional $5.0 million as described above), with an exercise price set at the lower of (i) $7.50 per share or (ii) the price per share of the next round of financing over the next twelve months, subject to customary anti-dilution adjustments. The warrants expire after 10 years and have piggyback registration rights with respect to the shares of common stock underlying the warrant. In addition, the Company has also granted Hercules the option to invest (until the loan maturity date) up to $1.0 million in future equity financings at the same terms as the other investors. | |
The Loan Agreement contains certain provisions that require the warrants issued to Hercules to be accounted for as a liability and “marked-to-market” each reporting period. Changes in the valuation of this liability at the end of each reporting period will be included in its reported operating results, and may create volatility in its reported operating results. | |
The fair value of the initial Loan Agreement warrant was calculated using a lattice-based option model in order to account for features in the warrant that could cause the exercise price to reset (“down round protection”) in the next issuance of our common stock (the next round of equity financing). The Company recorded the fair value of the warrant of $229,345 as warrant liability and as a debt discount to the carrying value of the loan. The key assumptions used to value the warrants included the expected date of the next round of equity financing, volatility of 59% on our common stock based upon similar public companies volatilities for comparison, an expected dividend yield of 0.0%, and a term of 10 years. As of October 22, 2013, the closing of the IPO, the Company recorded $186,055 as the fair value of the warrant, as additional paid in capital. As a result of the decrease in warrant liability, the Company recorded a $43,290 change in the fair value of warrant liability. This warrant liability was adjusted from inception of the initial Loan Agreement to October 22, 2013, to fair value each reporting period using a lattice-based option model and the debt discount will be amortized to interest expense over the term of the loan. Upon the completion of the IPO of common stock in October 2013, the down round warrant protection feature resulting in the warrant liability’s quarterly “marked-to-market” valuation terminated and, therefore, this liability was reclassified to additional paid-in capital during the fourth quarter of 2013. |
6_STOCKHOLDERS_EQUITY
6. STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2013 | |
Equity [Abstract] | ' |
6. STOCKHOLDERS' EQUITY | ' |
Hercules Debt Financing Warrant Issuance | |
In connection with the original Loan Agreement, the Company issued to Hercules a warrant to purchase 31,750 shares of common stock with an exercise price of $7.56, subject to customary anti-dilution adjustments. In connection with the Loan Amendment, the Company issued to Hercules a warrant to purchase 34,800 shares of common stock of the Company (and a warrant for an additional 23,200 shares of common stock if the Company borrows an additional $5.0 million as described above), with an exercise price set at the lower of (i) $7.50 per share or (ii) the price per share of the next round of financing over the next twelve months, subject to customary anti-dilution adjustments. The warrant expires after 10 years and has piggyback registration rights with respect to the shares of common stock underlying the warrant. | |
2012 Merger and Financing | |
On February 13, 2012, in connection with, and immediately prior to the closing of the Merger (as defined below), the Company completed a private placement (the “2012 Financing”) of 2,321,723 shares of the Company’s common stock at a price per share of $7.56 to accredited investors, for gross proceeds to the Company of $17,550,029 pursuant to a securities purchase agreement (the “Securities Purchase Agreement”). In lieu of repayment of senior secured promissory notes in the aggregate principal amount of $250,000 (plus $12,740 in accrued interest), the aggregate amount of unpaid principal and interest on the notes was invested by the holders of such notes in the 2012 Financing in exchange for shares of the Company’s common stock. The net cash proceeds from the 2012 Financing, after the payment of all expenses related to the 2012 Financing and the Merger, approximated $15.3 million. | |
The placement agent was paid a cash fee by the Company for its services. As additional compensation, the Company issued the placement agent warrants (the “Placement Agent Warrants”) to purchase 111,587 shares of common stock of the Company. The Placement Agent Warrants, which were exchanged for warrants of the Company in the Merger, are exercisable at $7.56 per share of Common Stock at any time beginning on August 11, 2012 and ending on February 12, 2017. The Company also agreed to reimburse the Placement Agent for up to $100,000 of expenses it incurred in connection with the 2012 Financing and to indemnify it against certain liabilities in connection with the 2012 Financing. | |
On February 13, 2012, the Company entered into a merger agreement whereby forming ADMA Acquisition Sub, Inc., a Delaware corporation (“Acquisition Sub”) (“Merger”). Upon closing of the Merger, Acquisition Sub was merged with and into the Company, and the Company, as the surviving corporation in the Merger, became a wholly-owned subsidiary of the Company and the corporate name was changed to ADMA Biologics, Inc. | |
For accounting purposes, the Merger was accounted for as a reverse acquisition, with the Company as the accounting acquiror (legal acquiree) and parentco as the accounting acquiree (legal acquiror), effectively a recapitalization of the Company. | |
Following the Merger, the Company is authorized by its certificate of incorporation to issue an aggregate of 85,000,000 shares of capital stock, of which 75,000,000 are shares of common stock and 10,000,000 are shares of preferred stock, each with a par value of $0.0001 per share. | |
During October and November the Company completed its IPO and overallotment of common stock by issuing 3,420,821 shares of its common stock, priced at $8.50 per share. Aggregate net proceeds to ADMA, after deducting underwriting discounts and commissions and expenses was $26.6 million. |
7_RELATED_PARTY_TRANSACTIONS
7. RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2013 | |
Related Party Transactions [Abstract] | ' |
7. RELATED PARTY TRANSACTIONS | ' |
The Company leases an office building and equipment from an entity owned by related parties on a month-to-month basis. Rent expense amounted to $96,448 for each of the years ended December 31, 2013 and 2012, respectively. The Company maintains deposits and other accounts at a bank which is less than 5%-owned by related parties and where a stockholder is a member of the Board of Directors of the bank. |
8_COMMITMENT_AND_CONTINGENCIES
8. COMMITMENT AND CONTINGENCIES | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||
8. COMMITMENT AND CONTINGENCIES | ' | ||||
Lease commitments | |||||
The Company has entered into leases for it ADMA BioCenters’ facilities located at 6290 Jimmy Carter Boulevard, Suite 208, Norcross, Georgia and in Marietta, Georgia. The Norcross, Georgia lease expires on September 30, 2023, and the Marietta, Georgia lease expires on January 31, 2024. Total rent expense for its New Jersey and Georgia facilities during the years ended 2013 and 2012 were approximately, $253,000 and $249,000, respectively. | |||||
Future minimum lease payments for both leases, for each of the five years ending December 31 and thereafter are as follows: | |||||
2014 | $ | 168,928 | |||
2015 | 330,176 | ||||
2016 | 348,383 | ||||
2017 | 353,059 | ||||
2018 | 356,774 | ||||
Thereafter | 1,998,966 | ||||
$ | 3,556,286 | ||||
Vendor and Licensor Commitments | |||||
On December 31, 2012, the Company entered into a Manufacturing, Supply and License Agreement with Biotest, which replaces a prior agreement that expired on December 31, 2012. Under the agreement, the Company agreed to purchase exclusively from Biotest its worldwide requirements of Respiratory Syncytial Virus (“RSV”) immune globulin manufactured from human plasma containing RSV antibodies. The term of the agreement is for a period of ten years from January 1, 2013, renewable for two additional five-year periods at the agreement of both parties. The Company is obligated under this agreement to purchase a minimum of at least one lot of product during each calendar year after the finished product is approved by the Food and Drug Administration (“FDA”). This number is subject to increase at the Company’s option. As consideration for Biotest’s obligations under the agreement, the Company is obligated to pay a dollar amount per lot of RSV immune globulin manufactured from human plasma containing RSV antibodies, as well as a percentage royalty on the sales thereof and of RI-002, up to a specified cumulative maximum. The agreement may be terminated by either party (a) by reason of a material breach if the breaching party fails to remedy the breach within 120 days after receiving notice of the breach from the other party, (b) upon bankruptcy, insolvency, dissolution, or winding up of the other party, or (c) if the other party is unable to fulfill its obligations under the agreement for 120 consecutive days or more as a result of (a) or (b) above. | |||||
In a separate license agreement effective December 31, 2012, the Company granted Biotest an exclusive license to market and sell RSV antibody-enriched Immune Globulin Intravenous (“IGIV”) in Europe and in selected countries in North Africa and the Middle East, collectively referred to as the Territory, to have access to the Company’s testing services for testing of Biotest’s plasma samples using the Company’s proprietary RSV assay, and to reference (but not access) the Company’s proprietary information for the purpose of Biotest seeking regulatory approval for the RSV antibody-enriched IGIV in the Territory. As consideration for the license, Biotest agreed to provide the Company with certain services at no charge and also compensate us with cash payments upon the completion of certain milestones. Such services have been accounted for as deferred revenue which were recorded in 2013 as a result of certain research and development services as provided for in accordance with a license agreement. Deferred revenue is recognized over the term of the license and is amortized into income for a period of approximately 20 years, the term of the license agreement. Biotest is also obligated to pay the Company an adjustable royalty based on a percentage of revenues from the sale of RSV antibody-enriched IGIV in the Territory for 20 years from the date of first commercial sale. Additionally, Biotest has agreed to grant the Company an exclusive license for marketing and sales in the United States and Canada for Biotest’s Varicella Zoster Immune Globulin (“VZIG”), the terms of which the Company expects to finalize by the end of the first half of 2014. As such, the Company expects to account for the value of this license as a charge to operations once the terms of the in-license agreement are finalized. | |||||
Pursuant to the terms of a Plasma Purchase Agreement with Biotest, the Company has agreed to purchase from Biotest an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of RI-002. This volume will increase at the earlier of our receipt of a Biologics License Application (“BLA”) from the FDA, or March 31, 2016. The Company must purchase a to-be-determined and agreed upon annual minimum volume from Biotest but may also collect high-titer RSV plasma from up to five wholly-owned ADMA BioCenters. Unless terminated earlier, the agreement expires in November 2021, after which it may be renewed for two additional five-year periods if agreed to by the parties. Either party may terminate the agreement if the other party fails to remedy any material default in the performance of any material condition or obligation under the agreement following notice. Either party may also terminate the agreement, after providing written notice, if a proceeding under any bankruptcy, reorganization, arrangement of debts, insolvency or receivership law is filed by or against the other party, and is not dismissed or stayed, or a receiver or trustee is appointed for all or a substantial portion of the assets of the other party, or the other party makes an assignment for the benefit of its creditors or becomes insolvent. The Company may also terminate the agreement upon written notice if the clinical development of our product candidate is halted or terminated, whether by the FDA, a Data Safety Monitoring Board, or any other regulatory authority. Upon termination of the agreement, the Company must pay for any source plasma already delivered to the Company and for any source plasma collected under the terms of the agreement. | |||||
Employment Contracts | |||||
The Company has entered into employment agreements with its executive management team consisting of its President and Chief Executive Officer, Chief Medical and Scientific Officer and Chief Financial Officer. In accordance with the employment agreements, the total financial obligation the Company has with the named executives totals approximately $1.5 million. | |||||
General Legal Matters | |||||
The Company is subject to certain legal proceedings and claims arising in connection with the normal course of our business. In the opinion of management, there are currently no claims that would have a material adverse effect on our consolidated financial position, results of operations or cash flows. | |||||
Other Commitments | |||||
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2013. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
9_STOCK_OPTIONS
9. STOCK OPTIONS | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
9. STOCK OPTIONS | ' | ||||||||||||||||
On July 16, 2007 (the “Effective Date”), the Company’s Board and stockholders adopted the 2007 Employee Stock Options Plan (the “Plan”). On July 17, 2012, the Company’s Board and stockholders amended the Plan to increase the aggregate number of options available for grant to 903,224. On February 21, 2014, the Board of Directors (the "Board") of the Company approved, subject to stockholder approval at the Company's 2014 Annual Meeting of Stockholders (the "Annual Meeting") of the 2014 Omnibus Incentive Compensation Plan of the Company (the “Prospective Plan”), incentive stock options to purchase an aggregate of 167,932 shares of the Company's common stock under the Prospective Plan, which is subject to stockholder approval at the Annual Meeting, to three of its executive officers, of which options to purchase 99,309 shares were approved by the Board for the Company’s President and Chief Executive Officer, Adam S. Grossman; options to purchase 39,032 shares were approved by the Board for the Company’s Chief Financial Officer, Brian Lenz; and options to purchase 29,591 shares were approved by the Board for the Company's Chief Scientific and Medical Officer, James Mond, M.D., Ph.D. The options will vest over a period of four years and are exercisable at a price per share of $8.50, the closing price of the Company’s common stock on the OTC Bulletin Board on February 21, 2014. The Board also approved, subject to stockholder approval at the Annual Meeting under the Prospective Plan, nonqualified stock options to purchase an aggregate of 54,000 shares of the Company’s common stock to its Board. Such options will vest over a period of two years and are exercisable at a price per share of $8.50, the closing price of the Company’s common stock on the OTC Bulletin Board on February 21, 2014. Additionally, the Board also, approved subject to stockholder approval at the Annual meeting under the Prospective Plan, 800,000 shares of common stock plus an annual increase to be added as of the first day of the Company’s fiscal year, beginning in 2015 and occurring each year thereafter through 2020, equal to the lower of 200,000, or 1% of the outstanding shares of common stock as of the end of the Company’s immediately preceding fiscal year and any lesser number of shares determined by the Board, provided that the aggregate number of shares available for issuance pursuant to such increases shall not exceed a total of 800,000 shares reserved for issuance under the terms of the Prospective Plan. | |||||||||||||||||
The Plan provides for the Board or a Committee of the Board (the “Committee”) to grant awards to optionees and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time. All options granted under the Plan are intended to be incentive stock options (“ISOs”), unless specified by the Committee to be non-qualified options (“NQOs”) as defined by the Internal Revenue Code. ISOs and NQOs may be granted to employees, consultants or Board members at an option price not less than the fair market value of the common stock subject to the Stock Option Agreement. The following table summarizes information about stock options outstanding as of December 31, 2013 and 2012: | |||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
31-Dec-13 | 31-Dec-12 | ||||||||||||||||
Weighted | Weighted | ||||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Shares | Price | Shares | Price | ||||||||||||||
Outstanding at beginning of year | 749,211 | $ | 6.86 | 105,890 | $ | 2.62 | |||||||||||
Forfeited | (6,350 | ) | $ | 7.56 | - | $ | - | ||||||||||
Granted | 84,134 | $ | 7.56 | 643,321 | $ | 7.56 | |||||||||||
Outstanding at end of year and expected to vest | 826,995 | $ | 6.9 | 749,211 | $ | 6.86 | |||||||||||
Options exercisable | 391,822 | $ | 6.23 | 175,022 | $ | 6.67 | |||||||||||
Weighted average fair value of options | |||||||||||||||||
granted during the period | $ | 4.35 | $ | 5.37 | |||||||||||||
The weighted average remaining contractual term of stock options outstanding and expected to vest at December 31, 2013 is 7.9 years. The weighted average remaining contractual term of stock options exercisable at December 31, 2013 is 7.0 years. | |||||||||||||||||
Stock-based compensation expense for the years ended December 31, 2013 and 2012 was: | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Research and development | $ | 227,085 | $ | 101,606 | |||||||||||||
General and administrative | 661,210 | 525,181 | |||||||||||||||
Total stock-based compensation expense | $ | 888,295 | $ | 626,787 | |||||||||||||
As of December 31, 2013, the total compensation expense related to unvested options not yet recognized totaled $2,283,314. The weighted-average vesting period over which the total compensation expense will be recorded related to unvested options not yet recognized at December 31, 2013 was approximately 2.6 years. As of December 31, 2013, the Company had 76,229 options available for future grant under the Plan. | |||||||||||||||||
The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2013 and (ii) the exercise price of the underlying awards, multiplied by the number of options that had an exercise price less than the closing price on the last trading day. Our outstanding and exercisable options had an intrinsic value of $591,574 as of December 31, 2013. |
10_INCOME_TAXES
10. INCOME TAXES | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
10. INCOME TAXES | ' | ||||||||
A reconciliation of income taxes at the U.S. Federal statutory rate to the benefit for income taxes is as follows: | |||||||||
Year Ended December 31, | |||||||||
2013 | 2012 | ||||||||
Benefit at US federal statutory rate | $ | (5,279,264 | ) | $ | (2,692,436 | ) | |||
State taxes - deferred | (901,800 | ) | (395,946 | ) | |||||
Increase in valuation allowance, inclusive of true-ups | 6,850,118 | 3,088,382 | |||||||
Research and development credits | (599,003 | ) | - | ||||||
Sale of state net operating loss | - | (617,615 | ) | ||||||
Other | (70,051 | ) | - | ||||||
Benefit for income taxes | $ | - | $ | (617,615 | ) | ||||
A summary of our deferred tax assets is as follows: | |||||||||
Year Ended December 31, | |||||||||
2013 | 2012 | ||||||||
Federal and state net operating loss carryforwards | $ | 16,791,893 | $ | 11,602,301 | |||||
Federal and state research credits | 2,846,245 | 1,938,664 | |||||||
Accrued expenses and other | 752,945 | - | |||||||
Total gross deferred taxassets | 20,391,083 | 13,540,965 | |||||||
Less: valuation allowance for deferred taxassets | (20,391,083 | ) | (13,540,965 | ) | |||||
Net deferred taxassets | $ | - | $ | - | |||||
As of December 31, 2013, the Company had Federal and state net operating loss carryforwards of approximately $44.1 million and $33.3 million, respectively. The Company also had Federal and state research and development tax credit carryforwards of approximately $2.2 million and $0.6 million, respectively. The net operating loss carryforwards and tax credits will expire at various dates beginning in 2027 if not utilized. | |||||||||
The Company received $617,615 in January 2012 from the sale of net operating loss and research and development credit carryforwards under the New Jersey Economic Development Authority Technology Business Tax Certificate Transfer Program. These amounts are recorded on the financial statements as income tax benefits in the year they are received. | |||||||||
11_SEGMENTS
11. SEGMENTS | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Segment Reporting [Abstract] | ' | ||||||||||||||||
11. SEGMENTS | ' | ||||||||||||||||
The Company is engaged in the development and commercialization of human plasma and plasma-derived therapeutics. The Company also operates an FDA-licensed source plasma collection facility located in Norcross, Georgia. The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze performance and allocate resources. The Company’s CODM, is its President and Chief Executive Officer. | |||||||||||||||||
The plasma collection center segment includes the Company’s operation in Georgia. The research and development segment includes the Company’s plasma development operations in New Jersey. | |||||||||||||||||
Summarized financial information concerning reportable segments is shown in the following table: | |||||||||||||||||
Year Ended December 31, | Plasma Collection | Research and | |||||||||||||||
2013 | Center | Development | Corporate | Consolidated | |||||||||||||
Revenues | $ | 3,023,503 | $ | - | $ | 44,074 | $ | 3,067,577 | |||||||||
Cost of product revenue | 2,023,441 | - | - | 2,023,441 | |||||||||||||
Gross profit | 1,000,062 | - | 44,074 | 1,044,136 | |||||||||||||
Loss from operations | (1,418,094 | ) | (9,303,077 | ) | (4,321,260 | ) | (15,042,431 | ) | |||||||||
Other expense | (7,582 | ) | - | (477,233 | ) | (484,815 | ) | ||||||||||
Loss before income taxes | (1,425,676 | ) | (9,303,077 | ) | (4,798,493 | ) | (15,527,246 | ) | |||||||||
Property and equipment, net | 587,032 | 2,729 | 175,538 | 765,299 | |||||||||||||
Depreciation and | |||||||||||||||||
amortization expense | 168,686 | 3,238 | 38,709 | 210,633 | |||||||||||||
Year Ended December 31, | Plasma Collection | Research and | |||||||||||||||
2012 | Center | Development | Corporate | Consolidated | |||||||||||||
Revenues | $ | 1,118,118 | $ | - | $ | - | $ | 1,118,118 | |||||||||
Cost of product revenue | 669,056 | - | - | 669,056 | |||||||||||||
Gross profit | 449,062 | - | - | 449,062 | |||||||||||||
Loss from operations | (1,297,802 | ) | (3,469,078 | ) | (3,142,289 | ) | (7,909,169 | ) | |||||||||
Other income (expense) | - | - | (9,759 | ) | (9,759 | ) | |||||||||||
Loss before income taxes | (1,297,802 | ) | (3,469,078 | ) | (3,152,048 | ) | (7,918,928 | ) | |||||||||
Property and equipment, net | 687,462 | 5,967 | 85,868 | 779,297 | |||||||||||||
Depreciation and | |||||||||||||||||
amortization expense | 164,514 | 4,558 | 13,017 | 182,089 | |||||||||||||
The “Corporate” column includes general and administrative overhead expenses. Property and equipment, net, included in the “Corporate” column above includes assets related to corporate and support functions. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU1
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Accounting Policies [Abstract] | ' | ||||
Basis of presentation | ' | ||||
Basis of presentation | |||||
The accompanying consolidated financial statements include the accounts of ADMA Biologics, Inc. and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. | |||||
Cash and cash equivalents | ' | ||||
Cash and cash equivalents | |||||
The Company considers all highly-liquid instruments purchased with a maturity of three months or less to be cash equivalents. The Company purchases certificates of deposits with maturity schedules of three, six, nine and twelve months. Instruments with maturity greater than three months but less than twelve months are included in short term investments. As of December 31, 2012, the Company had $0.5 million in restricted cash associated with a letter of credit related to our landlord agreement for our Georgia ADMA BioCenters facility. As of December 31, 2013, none of our cash was restricted and the letter of credit expired. | |||||
The Company regularly maintains cash and short term investments at third-party financial institutions in excess of the Federal Deposit Insurance Corporation, or FDIC, insurance limit. While the Company monitors the daily cash balances in the operating accounts and adjusts the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our business, if one or more of the financial institutions with which the Company has deposits fails or is subject to other adverse conditions in the financial or credit markets. To date, the Company has not experienced a loss or lack of access to its invested cash or cash equivalents; however, the Company cannot provide assurance that access to its invested cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets. | |||||
Inventories | ' | ||||
Inventories | |||||
Plasma inventories (both plasma intended for resale and plasma intended for internal use in our research and development activities) are carried at the lower of cost or market value determined on the first-in, first-out method. Once the research and development plasma is processed to a finished good for ongoing trials it is then expensed to research and development. Inventory at December 31, 2013 and 2012 consists of raw materials. Inventory also includes plasma collected at the Company’s FDA licensed plasma collection center. | |||||
Revenue recognition | ' | ||||
Revenue recognition | |||||
Revenue from the sale of human plasma collected at the Company’s FDA licensed plasma collection center and plasma-derived medicinal products is recognized at the time of transfer of title and risk of loss to the customer, which occurs at the time of shipment. Revenue is recognized at the time of delivery if the Company retains the risk of loss during shipment. The Company’s revenues are substantially attributed to one customer. Revenue from license fees and research and development services rendered are recognized as revenue when the performance obligations under the terms of the license agreement have been completed. Deferred revenue of $1.7 million was recorded in 2013 as a result of certain research and development services to be provided in accordance with a license agreement and is recognized over the term of the license. Deferred revenue is amortized into income for a period of approximately 20 years, the term of the license agreement. | |||||
Concentration of Significant Customers and Accounts Receivable | ' | ||||
Concentration of Significant Customers and Accounts Receivable | |||||
As of December 31, 2013 and 2012, the Company’s customers, revenues and trade receivable balances were substantially attributed to one customer. | |||||
Research and development costs | ' | ||||
Research and development costs | |||||
The Company expenses all research and development costs as incurred including plasma and equipment for which there is no alternative future use. Such expenses include licensing fees and costs associated with planning and conducting clinical trials. | |||||
Use of estimates | ' | ||||
Use of estimates | |||||
The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of inventory, assumptions used in the fair value of stock-based compensation, and the allowance for the valuation of future tax benefits. | |||||
Concentration of credit risk | ' | ||||
Concentration of credit risk | |||||
Financial instruments which potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and short-term investments. | |||||
Property and equipment | ' | ||||
Property and equipment | |||||
Fixed assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s estimated useful life, which is five to ten years. Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives. | |||||
Income taxes | ' | ||||
Income taxes | |||||
The Company recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax liabilities and assets are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred income tax assets if it is more likely than not that these deferred income tax assets will not be realized. | |||||
The Company has no unrecognized tax benefits at December 31, 2013 and 2012. The Company’s U.S. Federal and state income tax returns prior to fiscal year 2010 are closed and management continually evaluates expiring statutes of limitations, audits, proposed settlements, changes in tax law and new authoritative rulings. | |||||
The Company will recognize interest and penalties associated with tax matters as income tax expense. | |||||
Earnings (loss) per common share | ' | ||||
Earnings (Loss) Per Share | |||||
Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing net loss applicable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of common stock and dilutive common stock outstanding during the period. No potentially dilutive securities are included in the computation of any diluted per share amounts as the Company reported a net loss for all periods presented. Potentially dilutive securities that would be issued upon the exercise of outstanding warrants and stock options were 1.0 million at December 31, 2013 and 0.7 million at December 31, 2012. | |||||
Stock-based compensation | ' | ||||
Stock-based compensation | |||||
The Company follows recognized accounting guidance which requires all stock-based payments, including grants of stock options, to be recognized in the statement of operations as compensation expense, based on their fair values on the grant date. The estimated fair value of options granted under the Company’s 2007 Employee Stock Option Plan (the “Plan”) are recognized as compensation expense over the option-service period. | |||||
During the years ended December 31, 2013 and 2012, the Company recorded stock-based compensation expense to employees of $888,295 and $626,787, respectively. There were 84,134 and 506,559 options granted to employees and members of the Board of Directors for the years ended December 31, 2013 and 2012, respectively. For the year ended December 31, 2013, 6,350 options were forfeited due to an employee termination. | |||||
The fair value of employee options granted was determined on the date of grant using the Black-Scholes model. The Black-Scholes option valuation model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate. Because there is no public market for the Company’s stock and very little historical experience with the Company’s stock options, small similar publicly traded companies were used for comparison and expectations as to assumptions required for fair value computation using the Black-Scholes methodology. Guidance for stock-based compensation requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company currently estimates there will be no forfeitures of options. Due to the Company’s limited history, the Company uses the simplified method, to determine the expected life of the option grants, which is the average between vesting terms and contractual terms. | |||||
The Company records compensation expense associated with stock options and other forms of equity compensation using the Black-Scholes option-pricing model and the following assumptions: | |||||
Year Ended | |||||
31-Dec-13 | |||||
Expected term | 6.3 years | ||||
Volatility | 63% | ||||
Dividend yield | 0 | ||||
Risk-free interest rate | 1.24-2.25% | ||||
Fair value of financial instruments | ' | ||||
Fair value of financial instruments | |||||
The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, short-term investments, accounts payable, and notes payable are shown at cost which approximates fair value due to the short-term nature of these instruments. The carrying value of the long-term note payable bears interest at a rate per annum equal to the greater of (i) 8.75% and (ii) the sum of (a) 8.75% plus (b) the Prime Rate (as reported in The Wall Street Journal) minus (c) 5.75%, which approximates its fair value as of December 31, 2013 and also approximates the February 2014 terms of the amended loan agreement. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU2
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Summary Of Significant Accounting Policies Tables | ' | ||||
Schedule of assumptions used for equity compensation expense | ' | ||||
Year Ended | |||||
31-Dec-13 | |||||
Expected term | 6.3 years | ||||
Volatility | 63% | ||||
Dividend yield | 0 | ||||
Risk-free interest rate | 1.24-2.25% |
3_PROPERTY_AND_EQUIPMENT_Table
3. PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Property And Equipment Tables | ' | ||||||||
Schedule of property and equipment | ' | ||||||||
Property and equipment consist of the following at December 31, | 2013 | 2012 | |||||||
Lab and office equipment | $ | 674,885 | $ | 523,300 | |||||
Computer software | 184,077 | 141,277 | |||||||
Leasehold improvements | 942,353 | 940,103 | |||||||
1,801,315 | 1,604,680 | ||||||||
Less: Accumulated depreciation and amortization | (1,036,016 | ) | (825,383 | ) | |||||
$ | 765,299 | $ | 779,297 |
4_LEASEHOLD_IMPROVEMENT_LOAN_T
4. LEASEHOLD IMPROVEMENT LOAN (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Notes to Financial Statements | ' | ||||
Schedule Principal maturities under leasehold improvement loan | ' | ||||
2014 | $ | 12,654 | |||
2015 | 13,841 | ||||
2016 | 15,139 | ||||
2017 | 16,559 | ||||
2018 | 18,113 | ||||
2019 | 1,584 | ||||
$ | 77,890 |
8_COMMITMENTS_AND_CONTINGENCIE
8. COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||
Future minimum lease payments | ' | ||||
2014 | $ | 168,928 | |||
2015 | 330,176 | ||||
2016 | 348,383 | ||||
2017 | 353,059 | ||||
2018 | 356,774 | ||||
Thereafter | 1,998,966 | ||||
$ | 3,556,286 |
9_STOCK_OPTIONS_Tables
9. STOCK OPTIONS (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
Schedule of stock options outstanding | ' | ||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
31-Dec-13 | 31-Dec-12 | ||||||||||||||||
Weighted | Weighted | ||||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Shares | Price | Shares | Price | ||||||||||||||
Outstanding at beginning of year | 749,211 | $ | 6.86 | 105,890 | $ | 2.62 | |||||||||||
Forfeited | (6,350 | ) | $ | 7.56 | - | $ | - | ||||||||||
Granted | 84,134 | $ | 7.56 | 643,321 | $ | 7.56 | |||||||||||
Outstanding at end of year and expected to vest | 826,995 | $ | 6.9 | 749,211 | $ | 6.86 | |||||||||||
Options exercisable | 391,822 | $ | 6.23 | 175,022 | $ | 6.67 | |||||||||||
Weighted average fair value of options | |||||||||||||||||
granted during the period | $ | 4.35 | $ | 5.37 | |||||||||||||
Stock-based compensation expense | ' | ||||||||||||||||
2013 | 2012 | ||||||||||||||||
Research and development | $ | 227,085 | $ | 101,606 | |||||||||||||
General and administrative | 661,210 | 525,181 | |||||||||||||||
Total stock-based compensation expense | $ | 888,295 | $ | 626,787 |
10_INCOME_TAXES_Tables
10. INCOME TAXES (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
Schedule of reconciliation of income taxes | ' | ||||||||
Year Ended December 31, | |||||||||
2013 | 2012 | ||||||||
Benefit at US federal statutory rate | $ | (5,279,264 | ) | $ | (2,692,436 | ) | |||
State taxes - deferred | (901,800 | ) | (395,946 | ) | |||||
Increase in valuation allowance, inclusive of true-ups | 6,850,118 | 3,088,382 | |||||||
Research and development credits | (599,003 | ) | - | ||||||
Sale of state net operating loss | - | (617,615 | ) | ||||||
Other | (70,051 | ) | - | ||||||
Benefit for income taxes | $ | - | $ | (617,615 | ) | ||||
Schedule of deferred tax asset | ' | ||||||||
Year Ended December 31, | |||||||||
2013 | 2012 | ||||||||
Federal and state net operating loss carryforwards | $ | 16,791,893 | $ | 11,602,301 | |||||
Federal and state research credits | 2,846,245 | 1,938,664 | |||||||
Accrued expenses and other | 752,945 | - | |||||||
Total gross deferred taxassets | 20,391,083 | 13,540,965 | |||||||
Less: valuation allowance for deferred taxassets | (20,391,083 | ) | (13,540,965 | ) | |||||
Net deferred taxassets | $ | - | $ | - |
11_SEGMENTS_Tables
11. SEGMENTS (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Segment Reporting [Abstract] | ' | ||||||||||||||||
SEGMENTS | ' | ||||||||||||||||
Year Ended December 31, | Plasma Collection | Research and | |||||||||||||||
2013 | Center | Development | Corporate | Consolidated | |||||||||||||
Revenues | $ | 3,023,503 | $ | - | $ | 44,074 | $ | 3,067,577 | |||||||||
Cost of product revenue | 2,023,441 | - | - | 2,023,441 | |||||||||||||
Gross profit | 1,000,062 | - | 44,074 | 1,044,136 | |||||||||||||
Loss from operations | (1,418,094 | ) | (9,303,077 | ) | (4,321,260 | ) | (15,042,431 | ) | |||||||||
Other expense | (7,582 | ) | - | (477,233 | ) | (484,815 | ) | ||||||||||
Loss before income taxes | (1,425,676 | ) | (9,303,077 | ) | (4,798,493 | ) | (15,527,246 | ) | |||||||||
Property and equipment, net | 587,032 | 2,729 | 175,538 | 765,299 | |||||||||||||
Depreciation and | |||||||||||||||||
amortization expense | 168,686 | 3,238 | 38,709 | 210,633 | |||||||||||||
Year Ended December 31, | Plasma Collection | Research and | |||||||||||||||
2012 | Center | Development | Corporate | Consolidated | |||||||||||||
Revenues | $ | 1,118,118 | $ | - | $ | - | $ | 1,118,118 | |||||||||
Cost of product revenue | 669,056 | - | - | 669,056 | |||||||||||||
Gross profit | 449,062 | - | - | 449,062 | |||||||||||||
Loss from operations | (1,297,802 | ) | (3,469,078 | ) | (3,142,289 | ) | (7,909,169 | ) | |||||||||
Other income (expense) | - | - | (9,759 | ) | (9,759 | ) | |||||||||||
Loss before income taxes | (1,297,802 | ) | (3,469,078 | ) | (3,152,048 | ) | (7,918,928 | ) | |||||||||
Property and equipment, net | 687,462 | 5,967 | 85,868 | 779,297 | |||||||||||||
Depreciation and | |||||||||||||||||
amortization expense | 164,514 | 4,558 | 13,017 | 182,089 |
2_SUMMARY_OF_SIGNIFICANT_ACCOU3
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Summary Of Significant Accounting Policies Details Narrative | ' | ' |
Options issued to employees | 84,134 | 506,559 |
2_SUMMARY_OF_SIGNIFICANT_ACCOU4
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended |
Dec. 31, 2013 | |
Summary Of Significant Accounting Policies Tables | ' |
Expected term of options in years | '6 years 3 months 18 days |
Expected volatility | 63.00% |
Expected dividend yield | 0.00% |
Risk-free interest rate Minimum | 1.24% |
Risk-free interest rate Maximum | 2.25% |
3_PROPERTY_AND_EQUIPMENT_Detai
3. PROPERTY AND EQUIPMENT (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Property And Equipment Tables | ' | ' |
Lab and office equipment | $674,885 | $523,300 |
Computer software | 184,077 | 141,277 |
Leasehold improvements | 942,353 | 940,103 |
Total gross | 1,801,315 | 1,604,680 |
Less: accumulated depreciation and amortization | -1,036,016 | -825,383 |
Net | $765,299 | $779,297 |
4_LEASEHOLD_IMPROVEMENT_LOAN_D
4. LEASEHOLD IMPROVEMENT LOAN (Details) (USD $) | Dec. 31, 2013 |
Notes to Financial Statements | ' |
2014 | $12,654 |
2015 | 13,841 |
2016 | 15,139 |
2017 | 16,559 |
2018 | 18,113 |
2019 | 1,584 |
Total | $77,890 |
7_RELATED_PARTY_TRANSACTIONS_D
7. RELATED PARTY TRANSACTIONS (Details Narrative) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Related Party Transactions [Abstract] | ' | ' |
Rent expense | $96,448 | $96,448 |
8_COMMITMENTS_AND_CONTINGENCIE1
8. COMMITMENTS AND CONTINGENCIES (Details) (USD $) | Dec. 31, 2013 |
Commitments and Contingencies Disclosure [Abstract] | ' |
2014 | $168,928 |
2015 | 330,176 |
2016 | 348,383 |
2017 | 353,059 |
2018 | 356,774 |
Thereafter | 1,998,966 |
Total | $3,556,286 |
9_STOCK_OPTIONS_Details
9. STOCK OPTIONS (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Shares | ' | ' |
Outstanding at beginning of period | 749,211 | 105,890 |
Forfeited | -6,350 | 0 |
Granted | 84,134 | 643,321 |
Outstanding at end of period and expected to vest | 826,995 | 749,211 |
Options exercisable | 391,822 | 175,022 |
Weighted Average Exercise Price | ' | ' |
Outstanding at beginning of period | $6.86 | $2.62 |
Forfeited | $7.56 | $0 |
Granted | $7.56 | $7.56 |
Outstanding at end of period and expected to vest | $6.90 | $6.86 |
Options exercisable | $6.23 | $6.67 |
Weighted-average fair value of options granted during the period | $4.35 | $5.37 |
9_STOCK_OPTIONS_Details_1
9. STOCK OPTIONS (Details 1) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Stock-based compensation expenses | ' | ' |
Total stock-based compensation expense | $888,295 | $626,787 |
Research and Development Expense | ' | ' |
Stock-based compensation expenses | ' | ' |
Total stock-based compensation expense | 227,085 | 101,606 |
General and Administrative Expense | ' | ' |
Stock-based compensation expenses | ' | ' |
Total stock-based compensation expense | $661,210 | $525,181 |
10_INCOME_TAXES_Details
10. INCOME TAXES (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Income Tax Disclosure [Abstract] | ' | ' |
Benefit at US federal statutory rate | ($5,279,264) | ($2,692,436) |
State taxes - deferred | -901,800 | -395,946 |
Increase in valuation allowance, inclusive of true-ups | 6,850,118 | 3,088,382 |
Research and development credits | -599,003 | 0 |
Sale of state net operating loss | 0 | -617,615 |
Other | -70,051 | 0 |
Benefit for income taxes | $0 | ($617,615) |
10_INCOME_TAXES_Details_1
10. INCOME TAXES (Details 1) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
Deferred tax assets: | ' | ' |
Federal and state net operating loss carryforwards | $16,791,893 | $11,602,301 |
Federal and state research credits | 2,846,245 | 1,938,664 |
Accrued expenses and other | 752,945 | 0 |
Total gross deferred tax assets | 20,391,083 | 13,540,965 |
Less: valuation allowance for deferred tax assets | -20,391,083 | -13,540,965 |
Net deferred tax assets | $0 | $0 |
11_SEGMENTS_Details
11. SEGMENTS (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Summarized financial information concerning reportable segments | ' | ' |
Revenues | $3,067,577 | $1,118,118 |
Cost product revenue | 2,023,441 | 669,056 |
Gross profit | 1,044,136 | 449,062 |
Loss from operations | -15,042,431 | -7,909,169 |
Other (income) expense | -484,815 | -9,759 |
Loss before income taxes | -15,527,246 | -7,918,928 |
Property and equipment, net | 765,299 | 779,297 |
Depreciation and amortization expense | 210,633 | 182,089 |
Plasma Collection Center Member | ' | ' |
Summarized financial information concerning reportable segments | ' | ' |
Revenues | 3,023,503 | 1,118,118 |
Cost product revenue | 2,023,441 | 669,056 |
Gross profit | 1,000,062 | 449,062 |
Loss from operations | -1,418,094 | -1,297,802 |
Other (income) expense | -7,582 | 0 |
Loss before income taxes | -1,425,676 | -1,297,802 |
Property and equipment, net | 587,032 | 687,462 |
Depreciation and amortization expense | 168,686 | 164,514 |
Research And Development Member | ' | ' |
Summarized financial information concerning reportable segments | ' | ' |
Revenues | 0 | 0 |
Cost product revenue | 0 | 0 |
Gross profit | 0 | 0 |
Loss from operations | -9,303,077 | -3,469,078 |
Other (income) expense | 0 | 0 |
Loss before income taxes | -9,303,077 | -3,469,078 |
Property and equipment, net | 2,729 | 5,967 |
Depreciation and amortization expense | 3,238 | 4,558 |
Corporate Member | ' | ' |
Summarized financial information concerning reportable segments | ' | ' |
Revenues | 44,074 | 0 |
Cost product revenue | 0 | 0 |
Gross profit | 44,074 | 0 |
Loss from operations | -4,321,260 | -3,142,289 |
Other (income) expense | -477,233 | -9,759 |
Loss before income taxes | -4,798,493 | -3,152,048 |
Property and equipment, net | 175,538 | 85,868 |
Depreciation and amortization expense | $38,709 | $13,017 |