Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Oct. 31, 2013 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'ROCKWELL MEDICAL, INC. | ' |
Entity Central Index Key | '0001041024 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-13 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 39,997,961 |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
ASSETS | ' | ' |
Cash and Cash Equivalents | $21,212,826 | $4,711,730 |
Investments Available for Sale | 10,004,943 | 0 |
Accounts Receivable, net of a reserve of $32,800 in 2013 and $26,000 in 2012 | 4,222,411 | 4,431,932 |
Inventory | 2,814,165 | 2,649,639 |
Other Current Assets | 687,367 | 1,356,131 |
Total Current Assets | 38,941,712 | 13,149,432 |
Property and Equipment, net | 1,705,258 | 1,858,442 |
Intangible Assets | 541,472 | 666,744 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 1,492,214 | 429,723 |
Total Assets | 43,601,401 | 17,025,086 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ' | ' |
Loan Payable | 571,355 | ' |
Capitalized Lease Obligations | ' | 2,280 |
Accounts Payable | 7,111,561 | 14,833,565 |
Accrued Liabilities | 10,124,949 | 12,015,978 |
Customer Deposits | 263,825 | 135,133 |
Total Current Liabilities | 18,071,690 | 26,986,956 |
Long Term Debt | 19,428,645 | ' |
Shareholders' Equity: | ' | ' |
Common Shares, no par value, 39,997,961 and 21,494,696 shares issued and outstanding | 151,396,640 | 92,866,458 |
Common Share Purchase Warrants, 1,063,071 and 2,233,240 warrants issued and outstanding | 5,158,558 | 7,178,929 |
Accumulated Deficit | -150,458,464 | -110,007,257 |
Accumulated Other Comprehensive Income | 4,332 | ' |
Total Shareholders' Equity (Deficit) | 6,101,066 | -9,961,870 |
Total Liabilities And Shareholders' Equity | $43,601,401 | $17,025,086 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
CONSOLIDATED BALANCE SHEETS | ' | ' |
Allowance for reserve, accounts receivable (in dollars) | $32,800 | $26,000 |
Common Shares, par value (in dollars per share) | $0 | $0 |
Common Shares, shares issued | 39,997,961 | 21,494,696 |
Common Shares, shares outstanding | 39,997,961 | 21,494,696 |
Common Share Purchase Warrants, issued | 1,063,071 | 2,233,240 |
Common Share Purchase Warrants, outstanding | 1,063,071 | 2,233,240 |
CONSOLIDATED_INCOME_STATEMENTS
CONSOLIDATED INCOME STATEMENTS (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
CONSOLIDATED INCOME STATEMENTS | ' | ' | ' | ' |
Sales | $13,094,381 | $12,689,339 | $38,414,919 | $36,842,546 |
Cost of Sales | 11,461,100 | 11,043,412 | 33,815,593 | 31,851,344 |
Gross Profit | 1,633,281 | 1,645,927 | 4,599,326 | 4,991,202 |
Selling, General and Administrative | 3,386,367 | 3,325,411 | 10,541,124 | 9,048,474 |
Research and Product Development | 10,611,219 | 16,238,450 | 33,588,458 | 36,520,393 |
Operating Income (Loss) | -12,364,305 | -17,917,934 | -39,530,256 | -40,577,665 |
Interest and Investment Income, net | 13,546 | 42,296 | 28,784 | 230,484 |
Interest Expense | 857,505 | 137 | 949,735 | 846 |
Income (Loss) Before Income Taxes | -13,208,264 | -17,875,775 | -40,451,207 | -40,348,027 |
Income Tax Expense | 0 | ' | 0 | ' |
Net Income (Loss) | ($13,208,264) | ($17,875,775) | ($40,451,207) | ($40,348,027) |
Basic Earnings (Loss) per Share (in dollars per share) | ($0.34) | ($0.86) | ($1.32) | ($1.99) |
Diluted Earnings (Loss) per Share (in dollars per share) | ($0.34) | ($0.86) | ($1.32) | ($1.99) |
CONSOLIDATED_STATEMENTS_OF_COM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ' | ' | ' | ' |
Net Income (Loss) | ($13,208,264) | ($17,875,775) | ($40,451,207) | ($40,348,027) |
Unrealized Gain on Available-for-Sale Investments | 4,332 | 148,907 | 4,332 | 254,069 |
Comprehensive Income (Loss) | ($13,203,932) | ($17,726,868) | ($40,446,875) | ($40,093,958) |
CONSOLIDATED_STATEMENTS_OF_CHA
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (USD $) | Total | COMMON SHARES | PURCHASE WARRANTS | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) |
Balance at Dec. 31, 2012 | ($9,961,870) | $92,866,458 | $7,178,929 | ($110,007,257) | $0 |
Balance (purchase warrants in shares) at Dec. 31, 2012 | 2,233,240 | ' | 2,233,240 | ' | ' |
Balance (in shares) at Dec. 31, 2012 | 21,494,696 | 21,494,696 | ' | ' | ' |
Increase (Decrease) in Shareholders' Equity | ' | ' | ' | ' | ' |
Net Loss | -40,451,207 | ' | ' | -40,451,207 | ' |
Unrealized Gain (Loss) on Available-for-Sale Investments | 4,332 | ' | ' | ' | 4,332 |
Issuance of Common Shares | 50,260,374 | 50,260,374 | ' | ' | ' |
Issuance of Common Shares (in shares) | ' | 17,942,432 | ' | ' | ' |
Shares Issued in Exchange for Services | 392,000 | 392,000 | ' | ' | ' |
Shares Issued in Exchange for Services (in shares) | ' | 200,000 | ' | ' | ' |
Purchase Warrant Expense | 1,043,344 | ' | 1,043,344 | ' | ' |
Exercise of Purchase Warrants | 364,981 | 762,221 | -397,240 | ' | ' |
Exercise of Purchase Warrants (in shares) | ' | 50,833 | -161,833 | ' | ' |
Expiration of Purchase Warrants | ' | -2,666,475 | 2,666,475 | ' | ' |
Expiration of Purchase Warrants (in shares) | ' | ' | -1,008,336 | ' | ' |
Stock Option Based Expense | 3,026,933 | 3,026,933 | ' | ' | ' |
Restricted Stock Issuance (in shares) | ' | 310,000 | ' | ' | ' |
Restricted Stock Amortization | 1,422,179 | 1,422,179 | ' | ' | ' |
Balance at Sep. 30, 2013 | $6,101,066 | $151,396,640 | $5,158,558 | ($50,458,464) | $4,332 |
Balance (purchase warrants in shares) at Sep. 30, 2013 | 1,063,071 | ' | 1,063,071 | ' | ' |
Balance (in shares) at Sep. 30, 2013 | 39,997,961 | 39,997,961 | ' | ' | ' |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Cash Flows From Operating Activities: | ' | ' |
Net (Loss) | ($40,451,207) | ($40,348,027) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ' | ' |
Depreciation and Amortization | 752,360 | 828,676 |
Share Based Compensation - Non-employee | 1,435,344 | 1,309,502 |
Share Based Compensation- Employees | 4,449,110 | 3,727,224 |
Non-cash Interest Expense | 426,938 | ' |
Loss (Gain) on Disposal of Assets | 15,500 | 26,340 |
Changes in Assets and Liabilities: | ' | ' |
(Increase) Decrease in Accounts Receivable | 209,521 | -95,917 |
(Increase) in Inventory | -164,526 | -167,940 |
Decrease in Other Assets | 606,263 | 1,233,592 |
Increase (Decrease) in Accounts Payable | -7,722,004 | 2,726,145 |
Increase (Decrease) in Other Liabilities | -2,079,489 | 7,184,330 |
Changes in Assets and Liabilities | -9,150,235 | 10,880,210 |
Cash Provided By (Used In) Operating Activities | -42,522,190 | -23,576,075 |
Cash Flows From Investing Activities: | ' | ' |
Purchase of Equipment | -496,302 | -381,400 |
Proceeds on Sale of Assets | 6,898 | 1,578 |
Purchase of Intangible Assets | ' | -550,000 |
Sale of Investments Available for Sale | ' | 3,986,750 |
(Purchase) of Investments Available for Sale | -10,000,611 | -2,000,000 |
Cash (Used In) Investing Activities | -10,490,015 | 1,056,928 |
Cash Flows From Financing Activities: | ' | ' |
Proceeds from the Issuance of Common Shares and Purchase Warrants | 50,625,357 | 17,983,844 |
Proceeds from the Issuance of Notes Payable | 20,000,000 | ' |
Debt Issuance Costs | -1,109,776 | ' |
Payments on Capital Lease Obligations | -2,280 | -5,672 |
Cash Provided By Financing Activities | 69,513,301 | 17,978,172 |
Increase (Decrease) In Cash | 16,501,096 | -4,540,975 |
Cash At Beginning Of Period | 4,711,730 | 5,715,246 |
Cash At End Of Period | 21,212,826 | 1,174,271 |
Supplemental Cash Flow disclosure | ' | ' |
Interest Paid | $522,797 | $846 |
Description_of_Business
Description of Business | 9 Months Ended |
Sep. 30, 2013 | |
Description of Business | ' |
Description of Business | ' |
1. Description of Business | |
Rockwell Medical, Inc. and Subsidiary (collectively, “we”, “our”, “us”, or the “Company”) is a fully-integrated pharmaceutical company targeting end-stage renal disease (“ESRD”) and chronic kidney disease (“CKD”) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. | |
Rockwell’s lead drug candidate, Triferic™, also known as Soluble Ferric Pyrophosphate (SFP), in late-stage clinical development, is an iron replacement therapy for dialysis patients. The Company has completed the efficacy portion of its Phase 3 clinical studies (CRUISE-1 and CRUISE-2) and is preparing to file a new drug application for Triferic™ with the U. S. Food and Drug Administration (“FDA”). | |
Rockwell is preparing to launch its FDA approved generic drug, Calcitriol, to treat secondary hyperparathyroidism in dialysis patients. Calcitriol active vitamin D injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. Rockwell intends to launch Calcitriol as soon as it receives FDA manufacturing approval. | |
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. Rockwell’s products are used to maintain human life, by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three manufacturing and distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and Triferic™ upon FDA market approval. | |
We are regulated by the FDA under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies. We have received 510(k) approval from the FDA to market hemodialysis solutions and powders and related equipment. | |
We have obtained global licenses for certain dialysis related drugs which we are developing and are seeking FDA approval to market. We plan to devote substantial resources to the development, testing and FDA approval of our lead drug candidate. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended | |||||||||
Sep. 30, 2013 | ||||||||||
Summary of Significant Accounting Policies | ' | |||||||||
Summary of Significant Accounting Policies | ' | |||||||||
2. Summary of Significant Accounting Policies | ||||||||||
Basis of Presentation | ||||||||||
Our consolidated financial statements include our accounts and the accounts for our wholly owned subsidiary, Rockwell Transportation, Inc. All intercompany balances and transactions have been eliminated in consolidation. The accompanying consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2012 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. | ||||||||||
In the opinion of our management, all adjustments have been included which are necessary to make the financial statements not misleading. All of these adjustments that are material are of a normal and recurring nature. Our operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2012 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2012. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2012 includes a description of our significant accounting policies. | ||||||||||
Revenue Recognition | ||||||||||
We recognize revenue at the time we transfer title to our products to our customers consistent with generally accepted accounting principles. Generally, we recognize revenue when our products are delivered to our customer’s location consistent with our terms of sale. We recognize revenue for international shipments when title has transferred consistent with standard terms of sale. | ||||||||||
We require certain customers, mostly international customers, to pay for product prior to the transfer of title to the customer. Deposits received from customers and payments in advance for orders are recorded as liabilities under Customer Deposits until such time as orders are filled and title transfers to the customer consistent with our terms of sale. | ||||||||||
Cash and Cash Equivalents | ||||||||||
We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents. | ||||||||||
Investments Available for Sale | ||||||||||
Investments Available for Sale are short-term investments, consisting of investments in short term duration bond funds, and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy). These funds generally hold high credit quality short term debt instruments. These instruments are subject to changes in fair market value due primarily to changes in interest rates. The fair value of these investments was $10,004,943 as of September 30, 2013. There were no investments held as of December 31, 2012. Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss). Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense. Gross unrealized gains were $6,338 and gross unrealized losses were $2,006 as of September 30, 2013. | ||||||||||
The Company evaluated the near term interest rate environment, the expected holding period of the investments along with the duration of the fund portfolios in assessing the severity and duration of the potential impairment. Based on that evaluation the Company does not consider those investments to be other-than-temporarily impaired at September 30, 2013. | ||||||||||
Research and Product Development | ||||||||||
We recognize research and product development expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including our anemia related iron maintenance drug candidate, Triferic™, aggregating approximately $33.6 million and $36.5 million for the nine months ended September 30, 2013 and 2012, respectively. We are conducting human clinical trials on Triferic™. We recognize the costs of the human clinical trials as the costs are incurred and services performed over the duration of the trials. | ||||||||||
Net Earnings Per Share | ||||||||||
We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period. Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect. The calculation of basic weighted average shares outstanding excludes unvested restricted stock. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: | ||||||||||
Three Months | Three Months | Nine Months | Nine Months | |||||||
Ended | Ended | Ended | Ended | |||||||
September | September | September 30, | September 30, | |||||||
30, 2013 | 30, 2012 | 2013 | 2012 | |||||||
Basic Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 | ||||||
Effect of Dilutive Securities | — | — | — | — | ||||||
Diluted Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 |
Inventory
Inventory | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Inventory | ' | |||||||
Inventory | ' | |||||||
3. Inventory | ||||||||
Components of inventory as of September 30, 2013 and December 31, 2012 are as follows: | ||||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Raw Materials | $ | 1,085,794 | $ | 1,018,648 | ||||
Work in Process | 215,613 | 179,922 | ||||||
Finished Goods | 1,512,758 | 1,451,069 | ||||||
Total | $ | 2,814,165 | $ | 2,649,639 |
Loans_Payable
Loans Payable | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Loans Payable | ' | ||||
Loans Payable | ' | ||||
4. Loans Payable | |||||
As of June 14, 2013, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Technology III, L.P. (“Hercules”) pursuant to which the Company received a loan in the aggregate principal amount of $20.0 million. The Company is required to repay the aggregate principal balance under the Loan Agreement in 30 equal monthly installments of principal and interest commencing on September 1, 2014. | |||||
The loan will mature and become due on March 1, 2017, subject to adjustment as provided below, and will bear interest at the greater of (i) 12.50% plus the prime rate as reported in The Wall Street Journal minus 3.25%, or (ii) 12.50%. The Company will be required to make monthly interest only payments through August 31, 2014. Monthly principal and interest payments will be due on the loan following the interest only period through the maturity date. The loan may be prepaid at any time after June 14, 2014 without penalty and will mature and become due upon any change in control of the Company. The Company paid debt issuance costs of $1.1 million including a fee of $0.2 million at closing to Hercules, which are recorded as a noncurrent asset, and is required to pay a fee of $1.1 million upon any prepayment or at maturity. The $1.1 million fee due upon any prepayment or at maturity is accrued using the effective interest rate method over the life of the loan. The effective interest rate of the loan is 14.5%. | |||||
In connection with the loan, the Company granted Hercules a security interest in substantially all of the Company’s assets other than motor vehicles, real property and certain intellectual property and other interests. The Loan Agreement provides for standard indemnification of Hercules and contains representations, warranties and non-financial covenants of the Company. The Loan Agreement contains covenants that, among other things, limit the Company’s ability to incur additional indebtedness, transfer assets, acquire assets of or merge with another entity and pay dividends to the Company’s shareholders. The Loan Agreement defines event of default, to include, among other events, the occurrence of an event that results in a material adverse effect upon the Company’s business operations, properties, assets or condition (financial or otherwise), the collateral or the perfection of the security interest, or the Company’s ability to perform its obligations under the Loan Agreement. The Company was in compliance with the terms of the Loan Agreement and there was no event of default as of September 30, 2013. | |||||
The balance of the above debt matures at September 30, 2013 as follows: | |||||
2013 (remainder of year) | $ | — | |||
2014 | 2,308,145 | ||||
2015 | 7,544,935 | ||||
2016 | 8,555,035 | ||||
2017 | 1,591,885 | ||||
Total Principal Payable | $ | 20,000,000 | |||
Interest accrued on the loan payable through September 30, 2013 was $208,333. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | |||||||||
Sep. 30, 2013 | ||||||||||
Summary of Significant Accounting Policies | ' | |||||||||
Basis of Presentation | ' | |||||||||
Basis of Presentation | ||||||||||
Our consolidated financial statements include our accounts and the accounts for our wholly owned subsidiary, Rockwell Transportation, Inc. All intercompany balances and transactions have been eliminated in consolidation. The accompanying consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2012 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. | ||||||||||
In the opinion of our management, all adjustments have been included which are necessary to make the financial statements not misleading. All of these adjustments that are material are of a normal and recurring nature. Our operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2012 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2012. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2012 includes a description of our significant accounting policies. | ||||||||||
Revenue Recognition | ' | |||||||||
Revenue Recognition | ||||||||||
We recognize revenue at the time we transfer title to our products to our customers consistent with generally accepted accounting principles. Generally, we recognize revenue when our products are delivered to our customer’s location consistent with our terms of sale. We recognize revenue for international shipments when title has transferred consistent with standard terms of sale. | ||||||||||
We require certain customers, mostly international customers, to pay for product prior to the transfer of title to the customer. Deposits received from customers and payments in advance for orders are recorded as liabilities under Customer Deposits until such time as orders are filled and title transfers to the customer consistent with our terms of sale. | ||||||||||
Cash and Cash Equivalents | ' | |||||||||
Cash and Cash Equivalents | ||||||||||
We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents. | ||||||||||
Investments Available for Sale | ' | |||||||||
Investments Available for Sale | ||||||||||
Investments Available for Sale are short-term investments, consisting of investments in short term duration bond funds, and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy). These funds generally hold high credit quality short term debt instruments. These instruments are subject to changes in fair market value due primarily to changes in interest rates. The fair value of these investments was $10,004,943 as of September 30, 2013. There were no investments held as of December 31, 2012. Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss). Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense. Gross unrealized gains were $6,338 and gross unrealized losses were $2,006 as of September 30, 2013. | ||||||||||
The Company evaluated the near term interest rate environment, the expected holding period of the investments along with the duration of the fund portfolios in assessing the severity and duration of the potential impairment. Based on that evaluation the Company does not consider those investments to be other-than-temporarily impaired at September 30, 2013. | ||||||||||
Research and Product Development | ' | |||||||||
Research and Product Development | ||||||||||
We recognize research and product development expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including our anemia related iron maintenance drug candidate, Triferic™, aggregating approximately $33.6 million and $36.5 million for the nine months ended September 30, 2013 and 2012, respectively. We are conducting human clinical trials on Triferic™. We recognize the costs of the human clinical trials as the costs are incurred and services performed over the duration of the trials. | ||||||||||
Net Earnings Per Share | ' | |||||||||
Net Earnings Per Share | ||||||||||
We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period. Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect. The calculation of basic weighted average shares outstanding excludes unvested restricted stock. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: | ||||||||||
Three Months | Three Months | Nine Months | Nine Months | |||||||
Ended | Ended | Ended | Ended | |||||||
September | September | September 30, | September 30, | |||||||
30, 2013 | 30, 2012 | 2013 | 2012 | |||||||
Basic Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 | ||||||
Effect of Dilutive Securities | — | — | — | — | ||||||
Diluted Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | |||||||||
Sep. 30, 2013 | ||||||||||
Summary of Significant Accounting Policies | ' | |||||||||
Schedule of weighted average shares outstanding used in calculating basic and diluted earnings per share | ' | |||||||||
Three Months | Three Months | Nine Months | Nine Months | |||||||
Ended | Ended | Ended | Ended | |||||||
September | September | September 30, | September 30, | |||||||
30, 2013 | 30, 2012 | 2013 | 2012 | |||||||
Basic Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 | ||||||
Effect of Dilutive Securities | — | — | — | — | ||||||
Diluted Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 |
Inventory_Tables
Inventory (Tables) | 9 Months Ended | |||||||
Sep. 30, 2013 | ||||||||
Inventory | ' | |||||||
Schedule components of inventory | ' | |||||||
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Raw Materials | $ | 1,085,794 | $ | 1,018,648 | ||||
Work in Process | 215,613 | 179,922 | ||||||
Finished Goods | 1,512,758 | 1,451,069 | ||||||
Total | $ | 2,814,165 | $ | 2,649,639 |
Loans_Payable_Tables
Loans Payable (Tables) | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Loans Payable | ' | ||||
Schedule of debt maturity | ' | ||||
2013 (remainder of year) | $ | — | |||
2014 | 2,308,145 | ||||
2015 | 7,544,935 | ||||
2016 | 8,555,035 | ||||
2017 | 1,591,885 | ||||
Total Principal Payable | $ | 20,000,000 |
Description_of_Business_Detail
Description of Business (Details) | Sep. 30, 2013 |
facilities | |
Description of Business | ' |
Number of US manufacturing and distribution facilities | 3 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | |
Investments Available for Sale | ' | ' | ' | ' | ' |
Fair value of investments | $10,004,943 | ' | $10,004,943 | ' | $0 |
Gross unrealized gains | 6,338 | ' | 6,338 | ' | ' |
Gross unrealized losses | 2,006 | ' | 2,006 | ' | ' |
Research and Product Development | ' | ' | ' | ' | ' |
Product development and research costs | $10,611,219 | $16,238,450 | $33,588,458 | $36,520,393 | ' |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies (Details 2) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Weighted average shares outstanding used in calculating basic and diluted earnings per share | ' | ' | ' | ' |
Basic Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 |
Diluted Weighted Average Shares Outstanding | 39,327,994 | 20,726,967 | 30,652,944 | 20,244,518 |
Inventory_Details
Inventory (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Inventory | ' | ' |
Raw Materials | $1,085,794 | $1,018,648 |
Work in Process | 215,613 | 179,922 |
Finished Goods | 1,512,758 | 1,451,069 |
Total | $2,814,165 | $2,649,639 |
Loans_Payable_Details
Loans Payable (Details) (USD $) | 0 Months Ended | 9 Months Ended |
Jun. 14, 2013 | Sep. 30, 2013 | |
item | ||
Notes payable | ' | ' |
Debt issuance costs | ' | $1,109,776 |
Loan Agreement | ' | ' |
Notes payable | ' | ' |
Aggregate principal amount | 20,000,000 | ' |
Number of installments over which the loan is to be repaid | 30 | ' |
Maturity date | ' | 1-Mar-17 |
Interest rate under second condition (as a percent) | ' | 12.50% |
Debt issuance costs | 1,100,000 | ' |
Fee paid to Hercules | 200,000 | ' |
Fee due and accrued | ' | 1,100,000 |
Effective interest rate of loan (as a percent) | ' | 14.50% |
Maturities of debt | ' | ' |
2014 | ' | 2,308,145 |
2015 | ' | 7,544,935 |
2016 | ' | 8,555,035 |
2017 | ' | 1,591,885 |
Total Principal Payable | ' | 20,000,000 |
Interest accrued on the loan payable | ' | 208,333 |
Loan Agreement | Forecast | ' | ' |
Notes payable | ' | ' |
Fee paid to Hercules | ' | $1,100,000 |
Loan Agreement | Prime rate | ' | ' |
Notes payable | ' | ' |
Spread added to reference rate under first condition (as a percent) | ' | 12.50% |
Variable rate basis under first condition | ' | 'prime rate |
Percentage point deducted from reference rate to compute variable rate under first condition | ' | 3.25% |