Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 15, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'MIMEDX GROUP, INC. | ' |
Entity Central Index Key | '0001376339 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 106,938,400 |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $47,253,003 | $44,077,751 |
Accounts receivable, net | 23,304,472 | 16,092,836 |
Inventory, net | 4,738,690 | 3,880,776 |
Prepaid expenses and other current assets | 1,968,290 | 1,337,408 |
Total current assets | 77,264,455 | 65,388,771 |
Property and equipment, net of accumulated depreciation | 5,052,209 | 4,086,106 |
Goodwill | 4,040,443 | 4,040,443 |
Intangible assets, net of accumulated amortization | 10,960,300 | 11,178,573 |
Total assets | 97,317,407 | 84,693,893 |
Current liabilities: | ' | ' |
Accounts payable | 2,759,409 | 2,490,531 |
Accrued compensation | 9,448,245 | 5,588,811 |
Accrued expenses | 1,989,997 | 1,405,974 |
Other current liabilities | 251,578 | 122,551 |
Total current liabilities | 14,449,229 | 9,607,867 |
Other liabilities | 1,611,927 | 1,517,956 |
Total liabilities | 16,061,156 | 11,125,823 |
Commitments and contingencies (Note 11) | 0 | 0 |
Stockholders' equity: | ' | ' |
Preferred stock; $.001 par value; 5,000,000 shares authorized and 0 shares issued and outstanding | 0 | 0 |
Common stock; $.001 par value; 130,000,000 shares authorized; 107,834,036 issued and 106,889,570 outstanding as of September 30, 2014 and 104,425,614 issued and 104,375,614 outstanding as of December 31, 2013 | 107,834 | 104,426 |
Additional paid-in capital | 157,893,595 | 147,284,219 |
Treasury stock (944,466 shares as of September 30, 2014 and 50,000 shares as of December 31, 2013 at cost) | -5,337,077 | -25,000 |
Accumulated deficit | -71,408,101 | -73,795,575 |
Total stockholders' equity | 81,256,251 | 73,568,070 |
Total liabilities and stockholders' equity | $97,317,407 | $84,693,893 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Stockholders' equity: | ' | ' |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized (in shares) | 130,000,000 | 130,000,000 |
Common stock, shares issued (in shares) | 107,834,036 | 104,425,614 |
Common stock, shares outstanding (in shares) | 106,889,570 | 104,375,614 |
Treasury stock, shares (in shares) | 944,466 | 50,000 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Statement [Abstract] | ' | ' | ' | ' |
Net sales | $33,517,762 | $16,115,708 | $78,650,148 | $41,186,943 |
Cost of sales | 3,348,005 | 2,113,438 | 9,065,248 | 6,216,940 |
Gross margin | 30,169,757 | 14,002,270 | 69,584,900 | 34,970,003 |
Operating expenses: | ' | ' | ' | ' |
Research and development expenses | 2,014,306 | 1,287,361 | 5,204,153 | 3,458,585 |
Selling, general and administrative expenses | 24,192,479 | 12,711,225 | 61,237,264 | 31,948,607 |
Amortization of intangible assets | 232,079 | 259,575 | 695,368 | 789,809 |
Operating income (loss) | 3,730,893 | -255,891 | 2,448,115 | -1,226,998 |
Other income (expense), net | ' | ' | ' | ' |
Amortization of debt discount | 0 | 0 | 0 | -1,328,439 |
Interest expense, net | -9,126 | -4,527 | -38,579 | -32,503 |
Income (loss) before income tax provision | 3,721,767 | -260,418 | 2,409,536 | -2,587,940 |
Income tax provision | -22,062 | -46,700 | -22,062 | -96,975 |
Net income (loss) | $3,699,705 | ($307,118) | $2,387,474 | ($2,684,915) |
Net income (loss) per common share - basic | $0.03 | $0 | $0.02 | ($0.03) |
Net income (loss) per common share - diluted | $0.03 | $0 | $0.02 | ($0.03) |
Weighted average shares outstanding - basic | 105,756,945 | 96,914,856 | 105,331,344 | 95,429,988 |
Weighted average shares outstanding - diluted | 112,814,658 | 96,914,856 | 112,525,016 | 95,429,988 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (unaudited) (USD $) | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Deficit |
Balance at Dec. 31, 2013 | $73,568,070 | $104,426 | $147,284,219 | ($25,000) | ($73,795,575) |
Balance (in shares) at Dec. 31, 2013 | ' | 104,425,614 | ' | 50,000 | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' |
Share-based compensation expense | 8,160,678 | ' | 8,160,678 | ' | ' |
Exercise of stock options | 1,497,090 | 1,147 | 1,495,943 | ' | ' |
Exercise of stock options (in shares) | 1,146,987 | 1,146,987 | ' | ' | ' |
Exercise of warrants | 868,625 | 1,080 | 867,545 | ' | ' |
Exercise of warrants (in shares) | ' | 1,079,583 | ' | ' | ' |
Issuance of restricted stock | 0 | 1,168 | -1,168 | ' | ' |
Issuance of restricted stock (in shares) | ' | 1,168,694 | ' | ' | ' |
Shares issued for services performed | 86,391 | 13 | 86,378 | ' | ' |
Shares issued for services performed (in shares) | 13,158 | 13,158 | ' | ' | ' |
Stock repurchase | -5,312,077 | ' | ' | -5,312,077 | ' |
Stock repurchase (in shares) | ' | ' | ' | 894,466 | ' |
Net income | 2,387,474 | ' | ' | ' | 2,387,474 |
Balance at Sep. 30, 2014 | $81,256,251 | $107,834 | $157,893,595 | ($5,337,077) | ($71,408,101) |
Balance (in shares) at Sep. 30, 2014 | ' | 107,834,036 | ' | 944,466 | ' |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Cash flows from operating activities: | ' | ' |
Net income | $2,387,474 | ($2,684,915) |
Adjustments to reconcile net income (loss) to net cash from operating activities: | ' | ' |
Depreciation | 864,158 | 422,524 |
Amortization of intangible assets | 695,368 | 789,809 |
Amortization of debt discount and deferred financing costs | 0 | 1,328,439 |
Share-based compensation | 8,160,678 | 4,155,005 |
Increase (decrease) in cash resulting from changes in: | ' | ' |
Accounts receivable | -7,211,636 | -6,052,963 |
Inventory | -857,914 | -1,510,278 |
Prepaid expenses and other current assets | -630,882 | -913,644 |
Other assets | 0 | 70,000 |
Accounts payable | 355,269 | 954,094 |
Accrued compensation | 3,859,434 | 1,807,143 |
Accrued expenses | 584,023 | 419,462 |
Accrued interest | 0 | -41,641 |
Other liabilities | 311,520 | 132,302 |
Net cash flows from operating activities | 8,517,492 | -1,124,663 |
Cash flows from investing activities: | ' | ' |
Purchases of equipment | -1,830,261 | -2,008,407 |
Patent application costs | -477,095 | -526,566 |
Net cash flows from investing activities | -2,307,356 | -2,534,973 |
Cash flows from financing activities: | ' | ' |
Proceeds from exercise of warrants | 868,625 | 1,480,124 |
Proceeds from exercise of stock options | 1,497,090 | 1,516,580 |
Stock repurchase | -5,312,077 | 0 |
Principal payments of equipment leases | -88,522 | -29,797 |
Net cash flows from financing activities | -3,034,884 | 2,966,907 |
Net change in cash | 3,175,252 | -692,729 |
Cash and cash equivalents, beginning of period | 44,077,751 | 6,754,485 |
Cash and cash equivalents, end of period | $47,253,003 | $6,061,756 |
Basis_of_Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Basis of Presentation | ' |
Basis of Presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of Accounting Standards Updates (“ASU’’) to the FASB’s Accounting Standards Codification (“ASC”). In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the results of operations for the periods presented have been included. Operating results for the nine months ended September 30, 2014 and 2013, are not necessarily indicative of the results that may be expected for the fiscal year. The balance sheet at December 31, 2013, has been derived from the audited consolidated financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. | |
You should read these condensed consolidated financial statements together with the historical consolidated financial statements of the Company for the year ended December 31, 2013, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2013, filed with the SEC on March 4, 2014. | |
The Company operates in one business segment, Regenerative Biomaterials, which includes the design, manufacture, and marketing of products and tissue processing services for the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental market categories. The Company's biomaterial platform technologies include tissue technologies, AmnioFix® and EpiFix®, and device technology, CollaFix™. |
Significant_Accounting_Policie
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Significant Accounting Policies | ' |
Significant Accounting Policies | |
Please see Note 2 to the Company's Consolidated Financial Statements included in the Company’s Form 10-K for the fiscal year ended December 31, 2013, for a description of all significant accounting policies. | |
Use of Estimates | |
The preparation of financial statements in conformity with GAAP 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 revenue and expenses during the reporting period. Actual results could differ from those estimates. | |
Accounts Receivable | |
Accounts receivable represent amounts due from customers for which revenue has been recognized. Generally, the Company does not require collateral or any other security to support its receivables. | |
The allowance for doubtful accounts is the Company’s best estimate of the amount of probable credit losses in the Company’s existing receivables. The Company determines the allowance based on factors such as historical collection experience, customers' current creditworthiness, customer concentrations, age of accounts receivable balance and general economic conditions that may affect the customers' ability to pay. | |
Inventories | |
Inventory is valued at standard cost, which approximates actual cost computed on a first-in, first-out basis, not in excess of market value. The Company assesses the valuation of its inventory on a periodic basis and makes adjustments to the value for estimated excess and obsolete inventory based on estimates about future demand. The excess balance determined by this analysis becomes the basis for the Company's excess inventory charge. The Company's excess inventory review process includes analysis of sales forecasts, managing product rollovers and working with operations to maximize recovery of excess inventory. | |
Revenue Recognition | |
The Company sells its products through a combination of a direct sales force and independent stocking distributors and representatives in the U.S. and independent distributors in international markets. The Company recognizes revenue when title to the goods transfers to customers, provided there are no material remaining performance obligations required of the Company or any matters of customer acceptance. In cases where the Company utilizes distributors or ships product directly to the end user, it recognizes revenue upon shipment provided all revenue recognition criteria have been met. A portion of the Company's revenue is generated from inventory maintained at hospitals or with the field representatives. For these products, revenue is recognized at the time the product has been used or implanted. The Company records estimated sales returns, discounts and allowances as a reduction of net sales in the same period revenue is recognized. | |
Patent Costs | |
The Company incurs certain legal and related costs in connection with patent applications for tissue-based products and processes. The Company capitalizes such costs to be amortized over the expected life of the patent to the extent that an economic benefit is anticipated from the resulting patent or alternative future use is available to the Company and are included in Intangible Assets in the Condensed Consolidated Balance Sheets. The Company capitalized approximately $477,000 of patent costs during the first nine months of 2014. The Company capitalized approximately $527,000 of patent costs during the first nine months of 2013. | |
Recent Accounting Pronouncements | |
The Company considers the applicability and impact of all ASUs issued effective and not yet effective. In May 2014, the Financial Accounting Standards Board issued ASU 2014-09, “Revenue Recognition - Revenue from Contracts with Customers” (ASU 2014-09) that requires companies to recognize revenue when a customer obtains control rather than when companies have transferred substantially all risks and rewards of a good or service. This update is effective for annual reporting periods beginning on or after December 15, 2016 and interim periods therein and requires expanded disclosures. We are currently assessing the impact the adoption of ASU 2014-09 will have on our condensed consolidated financial statements. All other ASUs issued effective and not yet effective for the nine months ended September 30, 2014, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company's financial position or results of operations. |
Liquidity_and_Managements_Plan
Liquidity and Management's Plans | 9 Months Ended |
Sep. 30, 2014 | |
Liquidity and management's plans [Abstract] | ' |
Liquidity and Management's Plans | ' |
Liquidity and Management’s Plans | |
As of September 30, 2014, the Company had approximately $47,253,000 of cash and cash equivalents. The Company reported total current assets of approximately $77,264,000 and current liabilities of approximately $14,449,000 as of September 30, 2014. The Company believes that its anticipated cash from operating and financing activities, and existing cash and cash equivalents will enable the Company to meet its operational liquidity needs and fund its planned investing activities for the next twelve months. |
Inventories
Inventories | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Inventories | ' | |||||||
Inventories | ||||||||
Inventories consisted of the following items as of September 30, 2014, and December 31, 2013: | ||||||||
September 30, 2014 | December 31, 2013 | |||||||
Raw materials | $ | 270,191 | $ | 202,414 | ||||
Work in process | 3,228,525 | 2,951,704 | ||||||
Finished goods | 1,664,729 | 1,048,886 | ||||||
5,163,445 | 4,203,004 | |||||||
Reserve for obsolescence | (424,755 | ) | (322,228 | ) | ||||
Inventory, net | $ | 4,738,690 | $ | 3,880,776 | ||||
Property_and_Equipment
Property and Equipment | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
Property and Equipment | ' | |||||||
Property and Equipment | ||||||||
Property and equipment consist of the following as of September 30, 2014, and December 31, 2013: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Leasehold improvements | $ | 2,491,731 | $ | 2,319,928 | ||||
Lab and clean room equipment | 2,804,547 | 2,025,263 | ||||||
Furniture and office equipment | 2,090,776 | 1,240,466 | ||||||
Construction in progress | 831,183 | 802,319 | ||||||
8,218,237 | 6,387,976 | |||||||
Less accumulated depreciation | (3,166,028 | ) | (2,301,870 | ) | ||||
$ | 5,052,209 | $ | 4,086,106 | |||||
Included in net property and equipment is approximately $427,000 of equipment covered under capital leases. The corresponding liability is included in other liabilities in the accompanying Condensed Consolidated Balance Sheets. Interest rates for these leases range from approximately 3% to 12% with maturity dates from September 2016 to January 2018. | ||||||||
Also included is approximately $1.0 million in leasehold improvements paid for by the landlord of the Company's new facility with a corresponding liability included in other liabilities which is amortized over the term of the lease. | ||||||||
Depreciation expense for the nine months ended September 30, 2014 and 2013, was approximately $864,000 and $423,000, respectively, and $313,000 and $185,000 for the three months ended September 30, 2014 and 2013, respectively. |
Intangible_Assets_and_Royalty_
Intangible Assets and Royalty Agreement | 9 Months Ended | |||||||||
Sep. 30, 2014 | ||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | ' | |||||||||
Intangible Assets and Royalty Agreement | ' | |||||||||
Intangible Assets and Royalty Agreement | ||||||||||
Intangible assets are summarized as follows: | ||||||||||
Weighted | 30-Sep-14 | 31-Dec-13 | ||||||||
Average | Cost | Cost | ||||||||
Amortization | ||||||||||
Lives | ||||||||||
Licenses (a) (b) | 10 years | $ | 1,009,000 | $ | 1,009,000 | |||||
Patents & Know How (b) | 14 years | 7,888,856 | 7,798,910 | |||||||
Customer & Supplier Relationships (b) | 14 years | 3,761,000 | 3,761,000 | |||||||
Tradenames & Trademarks (b) | indefinite | 1,008,000 | 1,008,000 | |||||||
In Process Research & Development (b) | indefinite | 25,000 | 25,000 | |||||||
Patents in Process (c) | indefinite | 967,136 | 579,987 | |||||||
Total | 14,658,992 | 14,181,897 | ||||||||
Less Accumulated amortization | (3,698,692 | ) | (3,003,324 | ) | ||||||
Net | $ | 10,960,300 | $ | 11,178,573 | ||||||
(a) | On January 29, 2007, the Company acquired a license from Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. in the amount of $996,000. Within 30 days after the receipt by the Company of approval by the FDA allowing the sale of the first licensed product, the Company is required to pay an additional $200,000 to the licensor. Due to its contingent nature, this amount is not recorded as a liability. The Company will also be required to pay a royalty of 3% on all commercial sales revenue from the licensed products. The Company is also obligated to pay a $50,000 minimum annual royalty payment over the life of the license. As of September 30, 2014, this license had a remaining net book value of approximately $234,000. | |||||||||
(b) | On January 5, 2011, the Company acquired Surgical Biologics, LLC. As a result, the Company recorded intangible assets for Customer & Supplier Relationships of $3,761,000, Patents & Know-How of $7,690,000, Licenses of $13,000, Trade Names & Trademarks of $1,008,000 and In-Process Research & Development of $25,000. For the nine months ended September 30, 2014 an additional $89,946 of costs associated with patents granted during the period were capitalized and included in Patents & Know-How subject to amortization. | |||||||||
(c) | Patents in Process consist of capitalized external legal and other registration costs in connection with internally developed tissue-based patents that are pending. Once issued, the costs associated with a given patent will be included in Patents & Know-How under intangible assets subject to amortization. | |||||||||
Amortization expense for the nine months ended September 30, 2014 and 2013, was approximately $695,000, and $790,000, respectively, and $232,000 and $260,000 for the three months ended September 30, 2014 and 2013, respectively. | ||||||||||
Expected future amortization of intangible assets as of September 30, 2014, is as follows: | ||||||||||
Year ending December 31, | Estimated | |||||||||
Amortization | ||||||||||
Expense | ||||||||||
2014 (a) | $ | 232,306 | ||||||||
2015 | 929,226 | |||||||||
2016 | 929,226 | |||||||||
2017 | 839,593 | |||||||||
2018 | 829,626 | |||||||||
Thereafter | 6,192,323 | |||||||||
$ | 9,952,300 | |||||||||
(a) Estimated amortization expense for the year ending December 31, 2014, includes only amortization to be recorded after September 30, 2014. |
Net_Income_Loss_Per_Share
Net Income (Loss) Per Share | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||||
Net Income (loss) Per Share | ' | |||||||||||||||
Net Income (Loss) Per Share | ||||||||||||||||
Basic net income (loss) per common share is computed using the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is computed using the weighted-average number of common and dilutive common equivalent shares from stock options, restricted stock, and warrants (see Note 8) using the treasury stock method. For the three and nine months ended September 30, 2013, diluted net loss per share is the same as basic net loss per share, as the inclusion of equivalent shares from outstanding common stock options, restricted stock, and warrants would be anti-dilutive. | ||||||||||||||||
The following table sets forth the computation of basic and diluted net income (loss) per share: | ||||||||||||||||
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net income (loss) | $ | 3,699,705 | $ | (307,118 | ) | $ | 2,387,474 | $ | (2,684,915 | ) | ||||||
Denominator for basic earnings per share - weighted average shares | 105,756,945 | 96,914,856 | 105,331,344 | 95,429,988 | ||||||||||||
Effect of dilutive securities: Stock options, restricted stock, and warrants outstanding(a) | 7,057,713 | — | 7,193,672 | — | ||||||||||||
Denominator for diluted earnings per share - weighted average shares adjusted for dilutive securities | 112,814,658 | 96,914,856 | 112,525,016 | 95,429,988 | ||||||||||||
Income (loss) per common share - basic | $ | 0.03 | $ | — | $ | 0.02 | $ | (0.03 | ) | |||||||
Income (loss) per common share - diluted | $ | 0.03 | $ | — | $ | 0.02 | $ | (0.03 | ) | |||||||
(a) Securities outstanding that are included in the computation above, utilizing the treasury stock method for the three and nine months ended September 30, 2014, are as follows: | ||||||||||||||||
Three Months | Nine Months | |||||||||||||||
30-Sep-14 | ||||||||||||||||
Outstanding Stock Options | 6,651,994 | 6,752,310 | ||||||||||||||
Outstanding Warrants | 194,002 | 275,593 | ||||||||||||||
Restricted Stock Awards | 211,717 | 165,769 | ||||||||||||||
7,057,713 | 7,193,672 | |||||||||||||||
Securities outstanding for the three and nine months ended September 30, 2013 were excluded from the computation of diluted earnings per share because they would have been anti - dilutive. |
Equity
Equity | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Equity [Abstract] | ' | |||||||||||||||
Equity | ' | |||||||||||||||
Equity | ||||||||||||||||
Stock Incentive Plans | ||||||||||||||||
The Company has three share-based compensation plans: the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (the “2006 Plan”), the MiMedx Inc. 2007 Assumed Stock Plan (the “Assumed 2007 Plan”) and the MiMedx Group Inc. Amended and Restated Assumed 2005 Stock Plan (the “Assumed 2005 Plan”) which provide for the granting of qualified incentive and non-qualified stock options, stock appreciation awards and restricted stock awards to employees, directors, consultants and advisors. The awards are subject to a vesting schedule as set forth in each individual agreement. The Company intends to use only the 2006 Plan to make future grants. The number of assumed options under the Assumed 2005 Plan and Assumed 2007 Plan outstanding at September 30, 2014, totaled 375,000. On July 28, 2014, the Company's shareholders approved 4,000,000 additional shares to be made available under the 2006 Plan, bringing the maximum number of shares of common stock that can be issued under the 2006 Plan to 26,500,000 at September 30, 2014. | ||||||||||||||||
Activity with respect to the stock options is summarized as follows: | ||||||||||||||||
Number | Weighted- | Weighted-Average | Aggregate | |||||||||||||
of | Average | Remaining | Intrinsic | |||||||||||||
Shares | Exercise | Contractual Term | Value | |||||||||||||
Price | (in years) | |||||||||||||||
Outstanding at January 1, 2014 | 15,375,960 | $ | 2.46 | |||||||||||||
Granted | 2,948,969 | 7.03 | ||||||||||||||
Exercised | (1,146,987 | ) | 1.31 | |||||||||||||
Unvested options forfeited | (249,670 | ) | 4.04 | |||||||||||||
Vested options expired | (84,332 | ) | 0.81 | |||||||||||||
Outstanding at September 30, 2014 | 16,843,940 | 3.32 | 7.5 | $ | 64,630,326 | |||||||||||
Vested at September 30, 2014 | 8,987,368 | 1.87 | 6.7 | 47,252,742 | ||||||||||||
Vested or expected to vest at September 30, 2014 (a) | 16,515,621 | $ | 3.27 | 7.5 | $ | 64,242,362 | ||||||||||
(a) | Includes forfeiture adjusted unvested shares. | |||||||||||||||
The intrinsic value of the options exercised during the nine months ended September 30, 2014, was approximately $6,517,614. | ||||||||||||||||
Following is a summary of stock options outstanding and exercisable at September 30, 2014: | ||||||||||||||||
Options Outstanding | Options Exercisable | |||||||||||||||
Range of Exercise Prices | Number outstanding | Weighted-Average | Weighted- | Number Exercisable | Weighted- | |||||||||||
Remaining | Average | Average | ||||||||||||||
Contractual Term | Exercise | Exercise Price | ||||||||||||||
(in years) | Price | |||||||||||||||
$0.50 - $0.76 | 720,364 | 4.7 | $ | 0.72 | 720,364 | $ | 0.72 | |||||||||
$0.87 - $1.35 | 6,102,250 | 6.9 | 1.2 | 4,911,058 | 1.19 | |||||||||||
$1.40 - $2.29 | 1,482,701 | 5.3 | 1.64 | 1,361,032 | 1.65 | |||||||||||
$2.33 - $3.75 | 1,842,320 | 8 | 2.77 | 889,298 | 2.69 | |||||||||||
$3.95 - $5.99 | 3,443,402 | 8.6 | 5.15 | 911,797 | 5.02 | |||||||||||
$6.02 - $8.34 | 3,252,903 | 9 | 7.03 | 193,819 | 6.37 | |||||||||||
16,843,940 | 7.5 | $ | 3.32 | 8,987,368 | $ | 1.87 | ||||||||||
Total unrecognized compensation expense related to granted stock options at September 30, 2014, was approximately $16,675,914 and is expected to be recognized over a weighted-average period of 2.0 years. | ||||||||||||||||
The fair value of options granted by the Company is estimated on the date of grant using the Black-Scholes-Merton option-pricing model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on historical volatility of peer companies and other factors estimated over the expected term of the options. The term of employee options granted is derived using the “simplified method,” which computes expected term as the average of the sum of the vesting term plus the contract term. The term for non-employee options is generally based upon the contractual term of the option. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term or contractual term as described. | ||||||||||||||||
The assumptions used in calculating the fair value of options using the Black-Scholes-Merton option-pricing model are set forth in the following table: | ||||||||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | |||||||||||||||
Expected volatility | 63.6- 64.5% | 61.41 - 64.56% | ||||||||||||||
Expected life (in years) | 5.0 - 6.0 | 6 | ||||||||||||||
Expected dividend yield | — | — | ||||||||||||||
Risk-free interest rate | 1.69% - 1.96% | 0.85% -1.88% | ||||||||||||||
The weighted-average grant date fair value for options granted during the nine months ended September 30, 2014, was approximately $4.09. | ||||||||||||||||
Restricted Stock Awards | ||||||||||||||||
Activity with respect to restricted stock awards is summarized as follows: | ||||||||||||||||
Number | Weighted-Average Grant Date | |||||||||||||||
of | Fair Value | |||||||||||||||
Shares | ||||||||||||||||
Unvested at December 31, 2013 | 576,550 | $5.53 | ||||||||||||||
Granted | 592,864 | 7.05 | ||||||||||||||
Vested | (154,758 | ) | 5.72 | |||||||||||||
Forfeited | (720 | ) | 7.24 | |||||||||||||
Unvested at September 30, 2014 | 1,013,936 | $6.40 | ||||||||||||||
As of September 30, 2014, there was approximately $4,983,312 of total unrecognized stock-based compensation related to time-based, nonvested restricted stock. That expense is expected to be recognized on a straight-line basis over a weighted-average period of 2.1 years. All shares noted above as unvested are considered issued and outstanding at September 30, 2014. | ||||||||||||||||
Additionally, during the nine months ended September 30, 2014, 5,611 shares of common stock valued at approximately $39,000 were issued under the 2006 Plan to a consultant in return for services performed. | ||||||||||||||||
For the three and nine months ended September 30, 2014 and 2013, the Company recognized stock-based compensation as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Cost of sales | $ | 70,424 | $ | 75,287 | $ | 242,689 | $ | 198,119 | ||||||||
Research and development | 170,426 | 110,694 | 493,078 | 309,461 | ||||||||||||
Selling, general and administrative | 2,781,112 | 1,481,785 | 7,424,911 | 3,647,425 | ||||||||||||
$ | 3,021,962 | $ | 1,667,766 | $ | 8,160,678 | $ | 4,155,005 | |||||||||
Warrants | ||||||||||||||||
The Company grants common stock warrants in connection with equity share purchases by investors as an additional incentive for providing long term equity capital to the Company and as additional compensation to consultants and advisors. The warrants are granted at negotiated prices in connection with the equity share purchases and at the market price of the common stock in other instances. The warrants have been issued for terms of five years. | ||||||||||||||||
Following is a summary of the warrant activity for the nine months ended September 30, 2014: | ||||||||||||||||
Number | Weighted-Average | |||||||||||||||
of | Exercise Price | |||||||||||||||
Warrants | per warrant | |||||||||||||||
Warrants outstanding at January 1, 2014 | 1,284,816 | $ | 0.9 | |||||||||||||
Warrants exercised | (1,079,583 | ) | 0.8 | |||||||||||||
Warrants outstanding at September 30, 2014 | 205,233 | $ | 1.42 | |||||||||||||
Warrants may be exercised in whole or in part by notice given by the holder accompanied by payment in cash of an amount equal to the warrant exercise price multiplied by the number of warrant shares being purchased. | ||||||||||||||||
These warrants are not mandatorily redeemable, and do not obligate the Company to repurchase its equity shares by transferring assets or issuing a variable number of shares. | ||||||||||||||||
The warrants require that the Company deliver shares as part of a physical settlement and do not provide for a net-cash settlement. | ||||||||||||||||
All of the Company's warrants are classified as equity as of September 30, 2014, and December 31, 2013 and expire at various times through the end of 2016. |
Income_taxes
Income taxes | 9 Months Ended |
Sep. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
Income taxes | ' |
Income taxes | |
The effective tax rates for continuing operations of 0.92% and (3.75%), respectively, for the nine months ended September 30, 2014 and September 30, 2013, were determined using an estimated annual effective tax rate and after considering any discrete items for such periods. Due to a valuation allowance against the Company's U.S. deferred tax assets, the effective tax rate for the nine months ended September 30, 2014, does not include the benefit of the current period U.S. tax loss. A valuation allowance is recorded to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than not that a portion or none of the deferred tax assets will be realized. After consideration of all the evidence, including reversal of deferred tax liabilities, future taxable income and other factors, management has determined that a full valuation allowance is necessary as of September 30, 2014. As a result, income tax expense for the nine months ended September 30, 2014, is primarily due to income tax expense in certain state jurisdictions. |
Supplemental_disclosure_of_cas
Supplemental disclosure of cash flow and non-cash investing and financing activities | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Supplemental Cash Flow Elements [Abstract] | ' | |||||||
Supplemental disclosure of cash flow and non-cash investing and financing activities | ' | |||||||
Supplemental disclosure of cash flow and non-cash investing and financing activities: | ||||||||
Selected cash payments, receipts, and noncash activities are as follows: | ||||||||
Nine Months Ended September 30, | ||||||||
2014 | 2013 | |||||||
Cash paid for interest | $ | 38,347 | $ | 22,971 | ||||
Prepaid income taxes | 80,953 | 96,967 | ||||||
Purchases of equipment financed through capital leases | — | 107,259 | ||||||
Stock issuance of 13,158 shares in exchange for services performed | 86,391 | — | ||||||
Stock issuance of 5,272,004 shares in exchange for convertible debt | — | 5,272,004 | ||||||
Tenant improvement incentive | — | 996,866 | ||||||
Contractual_Commitments_and_Co
Contractual Commitments and Contingencies | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Commitments and Contingencies Disclosure [Abstract] | ' | |||
Contractual Commitments and Contingencies | ' | |||
Contractual Commitments and Contingencies | ||||
Contractual Commitments | ||||
In addition to the Capital Leases noted above in Note 5, the Company has entered into operating lease agreements for facility space and equipment. These leases expire over the next five years and generally contain renewal options. The Company anticipates that most of these leases will be renewed or replaced upon expiration. The Company also has commitments for meeting space and to various charitable organizations. The estimated annual lease payments, meeting space and charitable organization commitments are as follows: | ||||
12-month period ended September 30 | ||||
2015 | $ | 1,879,579 | ||
2016 | 1,863,354 | |||
2017 | 1,523,923 | |||
2018 | 1,463,054 | |||
2019 | 478,325 | |||
$ | 7,208,235 | |||
Rent expense for the nine months ended September 30, 2014 and 2013, was approximately $847,000 and $762,000, respectively, and was $282,000 and $364,000 for the three months ended September 30, 2014 and 2013, respectively, and is allocated among cost of sales, research and development, and selling, general and administrative expenses. | ||||
Letters of Credit | ||||
As a condition of the leases for the Company's facilities, the Company is obligated under standby letters of credit in the amount of approximately $500,000. These obligations are reduced at various times over the lives of the leases. | ||||
FDA Untitled Letter and Related Litigation | ||||
Initially, MiMedx processed its tissue allografts in only one form, which was a sheet form. In 2011, MiMedx introduced a micronized form of its sheet allografts. | ||||
The FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps. An HCT/P is a product containing or consisting of human cells or tissue intended for transplantation into a human patient. If an HCT/P meets the criteria for regulation solely under Section 361 of the Public Health Service Act (so-called “361 HCT/Ps”), no FDA review for safety and effectiveness under a drug, device, or biological product marketing application is required. | ||||
MiMedx believes that all of its tissue products qualify as 361 HCT/Ps. On August 28, 2013, however, the FDA issued an Untitled Letter alleging that the Company’s micronized allografts do not meet the criteria for regulation solely under Section 361 of the Public Health Service Act and that, as a result, MiMedx would need a biologics license to lawfully market the micronized products. | ||||
In December 2013, the FDA clarified the basis for its position regarding the micronized products. Specifically, the FDA explained its belief that “[c]ryo-milling cut, dehydrated amniotic/chorionic membrane results in a micron-sized powder and the loss of the tensile strength and elasticity that are essential characteristics of the original amniotic/chorionic tissue relating to its utility to function as a ‘physical membrane’ (i.e. covering, barrier).” The Company responded to the FDA that while it does not agree with the Agency’s position, it understands the Agency’s interest in further regulating this emerging technology. Accordingly, the Company proposed to the FDA that it would pursue the Investigational New Drug (“IND”) and Biologics License Application (“BLA”) process for certain micronized products, and, in parallel, also proposed to enter into negotiations with the FDA on a plan to transition the micronized products to licensed biological products and continue to market the micronized products under specific conditions. | ||||
On July 22, 2014, the Company filed its first IND application with the FDA. The application was allowed, paving the way for a Phase IIb clinical trial of its micronized product for a specified indication of use in anticipation of a BLA, which the Company expects to submit at a future date. The clinical trial is expected to enroll approximately 150 patients in 10 - 20 clinical sites in the U.S. The Company anticipates initiating the trial in the first half of 2015. | ||||
The Company also requested a transition agreement to allow it to continue to market its current micronized products for certain specified uses while pursuing one or more BLAs. The Agency continues to assert that the current form of the Company’s micronized products are more than minimally manipulated and therefore are not eligible for marketing solely under Section 361 of the Public Health Service Act. The Company has asked the FDA to consider alternative formulations of the Company’s particulate products and is awaiting a response. The Company also has conducted tests and has engaged independent laboratories to conduct tests that confirm that tensile strength and elasticity are not diminished by the Company’s micronization process. | ||||
If the FDA does allow the Company to continue to market a particulate form of its sheet allografts, they may impose conditions, such as labeling restrictions and compliance with Current Good Manufacturing Practices (“cGMP”). It is also possible that the FDA will not allow the Company to market any form of a particulate product without a biologics license and could even require us to recall our current products. Revenues from micronized products make up about 15% of projected revenues in 2014. | ||||
Following the publication of the Untitled Letter from the FDA regarding the Company’s micronized products in September 2013, the trading price of the Company’s stock dropped sharply and several purported class action lawsuits were filed against the Company and certain of its executive officers asserting violations of the Securities Act of 1933 and the Securities Exchange Act of 1934 with respect to various statements and alleged omissions related to the Company’s belief that FDA approval was not required to market its products, including its micronized products. These cases have now all been removed to, and consolidated in, the United States District Court for the Northern District of Georgia. By order dated December 9, 2013, the Court approved the appointment of a lead plaintiff and a lead counsel. A Consolidated Amended Class Action Complaint, containing substantially the same causes of action and claims for relief as the initial complaints, was filed on January 27, 2014. On February 26, 2014, the Company filed a Motion to Dismiss on various grounds. The Court subsequently denied the Company’s Motion to Dismiss. On September 8, 2014, the Company filed a Motion for Reconsideration, which is currently pending. The Company currently believes that the outcome of this litigation will not have a material adverse impact on the Company's financial position or results of operations. |
Subsequent_Events_Notes
Subsequent Events (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Subsequent Events [Abstract] | ' |
Subsequent Events | ' |
Subsequent Events | |
None |
Schedule_II_Valuation_and_Qual
Schedule II - Valuation and Qualifying Accounts | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Valuation and Qualifying Accounts [Abstract] | ' | |||||||||||||
Schedule II - Valuation and Qualifying Accounts | ' | |||||||||||||
Schedule II Valuation and Qualifying Accounts | ||||||||||||||
MIMEDX GROUP, INC. AND SUBSIDIARIES | ||||||||||||||
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS | ||||||||||||||
Three and Nine Months Ended September 30, 2014 and 2013 | ||||||||||||||
Balance at | Additions charged to Expense or Revenue | Deductions | Balance at | |||||||||||
Beginning of Period | and write-offs | End of Period | ||||||||||||
For the Quarter ended September 30, 2014 | ||||||||||||||
Allowance for doubtful accounts | $ | 678,000 | $ | 523,000 | $ | — | $ | 1,201,000 | ||||||
Allowance for product returns | 270,000 | 806,000 | (399,000 | ) | 677,000 | |||||||||
Allowance for obsolescence | 352,000 | 76,000 | (3,000 | ) | 425,000 | |||||||||
For the Quarter ended September 30, 2013 | ||||||||||||||
Allowance for doubtful accounts | 44,000 | 73,000 | (2,000 | ) | 115,000 | |||||||||
Allowance for product returns | 162,000 | 178,000 | (153,000 | ) | 187,000 | |||||||||
Allowance for obsolescence | 242,000 | 131,000 | — | 373,000 | ||||||||||
For the nine months ended September 30, 2014 | ||||||||||||||
Allowance for doubtful accounts | 407,000 | 808,000 | (14,000 | ) | 1,201,000 | |||||||||
Allowance for product returns | 215,000 | 1,419,000 | (957,000 | ) | 677,000 | |||||||||
Allowance for obsolescence | 322,000 | 140,000 | (37,000 | ) | 425,000 | |||||||||
For the nine months ended September 30, 2013 | ||||||||||||||
Allowance for doubtful accounts | 49,000 | 99,000 | (33,000 | ) | 115,000 | |||||||||
Allowance for product returns | 88,000 | 648,000 | (549,000 | ) | 187,000 | |||||||||
Allowance for obsolescence | 159,000 | 214,000 | — | 373,000 | ||||||||||
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Use of estimates | ' |
Use of Estimates | |
The preparation of financial statements in conformity with GAAP 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 revenue and expenses during the reporting period. Actual results could differ from those estimates. | |
Accounts Receivable | ' |
Accounts Receivable | |
Accounts receivable represent amounts due from customers for which revenue has been recognized. Generally, the Company does not require collateral or any other security to support its receivables. | |
The allowance for doubtful accounts is the Company’s best estimate of the amount of probable credit losses in the Company’s existing receivables. The Company determines the allowance based on factors such as historical collection experience, customers' current creditworthiness, customer concentrations, age of accounts receivable balance and general economic conditions that may affect the customers' ability to pay. | |
Inventories | ' |
Inventories | |
Inventory is valued at standard cost, which approximates actual cost computed on a first-in, first-out basis, not in excess of market value. The Company assesses the valuation of its inventory on a periodic basis and makes adjustments to the value for estimated excess and obsolete inventory based on estimates about future demand. The excess balance determined by this analysis becomes the basis for the Company's excess inventory charge. The Company's excess inventory review process includes analysis of sales forecasts, managing product rollovers and working with operations to maximize recovery of excess inventory. | |
Revenue Recognition | ' |
Revenue Recognition | |
The Company sells its products through a combination of a direct sales force and independent stocking distributors and representatives in the U.S. and independent distributors in international markets. The Company recognizes revenue when title to the goods transfers to customers, provided there are no material remaining performance obligations required of the Company or any matters of customer acceptance. In cases where the Company utilizes distributors or ships product directly to the end user, it recognizes revenue upon shipment provided all revenue recognition criteria have been met. A portion of the Company's revenue is generated from inventory maintained at hospitals or with the field representatives. For these products, revenue is recognized at the time the product has been used or implanted. The Company records estimated sales returns, discounts and allowances as a reduction of net sales in the same period revenue is recognized. | |
Patent Costs | ' |
Patent Costs | |
The Company incurs certain legal and related costs in connection with patent applications for tissue-based products and processes. The Company capitalizes such costs to be amortized over the expected life of the patent to the extent that an economic benefit is anticipated from the resulting patent or alternative future use is available to the Company and are included in Intangible Assets in the Condensed Consolidated Balance Sheets. The Company capitalized approximately $477,000 of patent costs during the first nine months of 2014. The Company capitalized approximately $527,000 of patent costs during the first nine months of 2013. | |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements | |
The Company considers the applicability and impact of all ASUs issued effective and not yet effective. In May 2014, the Financial Accounting Standards Board issued ASU 2014-09, “Revenue Recognition - Revenue from Contracts with Customers” (ASU 2014-09) that requires companies to recognize revenue when a customer obtains control rather than when companies have transferred substantially all risks and rewards of a good or service. This update is effective for annual reporting periods beginning on or after December 15, 2016 and interim periods therein and requires expanded disclosures. We are currently assessing the impact the adoption of ASU 2014-09 will have on our condensed consolidated financial statements. All other ASUs issued effective and not yet effective for the nine months ended September 30, 2014, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company's financial position or results of operations |
Inventories_Tables
Inventories (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Inventory | ' | |||||||
Inventories consisted of the following items as of September 30, 2014, and December 31, 2013: | ||||||||
September 30, 2014 | December 31, 2013 | |||||||
Raw materials | $ | 270,191 | $ | 202,414 | ||||
Work in process | 3,228,525 | 2,951,704 | ||||||
Finished goods | 1,664,729 | 1,048,886 | ||||||
5,163,445 | 4,203,004 | |||||||
Reserve for obsolescence | (424,755 | ) | (322,228 | ) | ||||
Inventory, net | $ | 4,738,690 | $ | 3,880,776 | ||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Property, Plant and Equipment [Abstract] | ' | |||||||
Property and Equipment | ' | |||||||
Property and equipment consist of the following as of September 30, 2014, and December 31, 2013: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Leasehold improvements | $ | 2,491,731 | $ | 2,319,928 | ||||
Lab and clean room equipment | 2,804,547 | 2,025,263 | ||||||
Furniture and office equipment | 2,090,776 | 1,240,466 | ||||||
Construction in progress | 831,183 | 802,319 | ||||||
8,218,237 | 6,387,976 | |||||||
Less accumulated depreciation | (3,166,028 | ) | (2,301,870 | ) | ||||
$ | 5,052,209 | $ | 4,086,106 | |||||
Intangible_Assets_and_Royalty_1
Intangible Assets and Royalty Agreement (Tables) | 9 Months Ended | |||||||||
Sep. 30, 2014 | ||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | ' | |||||||||
Intangible assets activity summary | ' | |||||||||
Intangible assets are summarized as follows: | ||||||||||
Weighted | 30-Sep-14 | 31-Dec-13 | ||||||||
Average | Cost | Cost | ||||||||
Amortization | ||||||||||
Lives | ||||||||||
Licenses (a) (b) | 10 years | $ | 1,009,000 | $ | 1,009,000 | |||||
Patents & Know How (b) | 14 years | 7,888,856 | 7,798,910 | |||||||
Customer & Supplier Relationships (b) | 14 years | 3,761,000 | 3,761,000 | |||||||
Tradenames & Trademarks (b) | indefinite | 1,008,000 | 1,008,000 | |||||||
In Process Research & Development (b) | indefinite | 25,000 | 25,000 | |||||||
Patents in Process (c) | indefinite | 967,136 | 579,987 | |||||||
Total | 14,658,992 | 14,181,897 | ||||||||
Less Accumulated amortization | (3,698,692 | ) | (3,003,324 | ) | ||||||
Net | $ | 10,960,300 | $ | 11,178,573 | ||||||
(a) | On January 29, 2007, the Company acquired a license from Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. in the amount of $996,000. Within 30 days after the receipt by the Company of approval by the FDA allowing the sale of the first licensed product, the Company is required to pay an additional $200,000 to the licensor. Due to its contingent nature, this amount is not recorded as a liability. The Company will also be required to pay a royalty of 3% on all commercial sales revenue from the licensed products. The Company is also obligated to pay a $50,000 minimum annual royalty payment over the life of the license. As of September 30, 2014, this license had a remaining net book value of approximately $234,000. | |||||||||
(b) | On January 5, 2011, the Company acquired Surgical Biologics, LLC. As a result, the Company recorded intangible assets for Customer & Supplier Relationships of $3,761,000, Patents & Know-How of $7,690,000, Licenses of $13,000, Trade Names & Trademarks of $1,008,000 and In-Process Research & Development of $25,000. For the nine months ended September 30, 2014 an additional $89,946 of costs associated with patents granted during the period were capitalized and included in Patents & Know-How subject to amortization. | |||||||||
(c) | Patents in Process consist of capitalized external legal and other registration costs in connection with internally developed tissue-based patents that are pending. Once issued, the costs associated with a given patent will be included in Patents & Know-How under intangible assets subject to amortization. | |||||||||
Estimated future amortization expense for intangible assets | ' | |||||||||
Expected future amortization of intangible assets as of September 30, 2014, is as follows: | ||||||||||
Year ending December 31, | Estimated | |||||||||
Amortization | ||||||||||
Expense | ||||||||||
2014 (a) | $ | 232,306 | ||||||||
2015 | 929,226 | |||||||||
2016 | 929,226 | |||||||||
2017 | 839,593 | |||||||||
2018 | 829,626 | |||||||||
Thereafter | 6,192,323 | |||||||||
$ | 9,952,300 | |||||||||
(a) Estimated amortization expense for the year ending December 31, 2014, includes only amortization to be recorded after September 30, 2014. |
Net_Income_Loss_Per_Share_Tabl
Net Income (Loss) Per Share (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||||
Computation of Basic and Diluted Net Loss per Share | ' | |||||||||||||||
The following table sets forth the computation of basic and diluted net income (loss) per share: | ||||||||||||||||
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net income (loss) | $ | 3,699,705 | $ | (307,118 | ) | $ | 2,387,474 | $ | (2,684,915 | ) | ||||||
Denominator for basic earnings per share - weighted average shares | 105,756,945 | 96,914,856 | 105,331,344 | 95,429,988 | ||||||||||||
Effect of dilutive securities: Stock options, restricted stock, and warrants outstanding(a) | 7,057,713 | — | 7,193,672 | — | ||||||||||||
Denominator for diluted earnings per share - weighted average shares adjusted for dilutive securities | 112,814,658 | 96,914,856 | 112,525,016 | 95,429,988 | ||||||||||||
Income (loss) per common share - basic | $ | 0.03 | $ | — | $ | 0.02 | $ | (0.03 | ) | |||||||
Income (loss) per common share - diluted | $ | 0.03 | $ | — | $ | 0.02 | $ | (0.03 | ) | |||||||
(a) Securities outstanding that are included in the computation above, utilizing the treasury stock method for the three and nine months ended September 30, 2014, are as follows: | ||||||||||||||||
Three Months | Nine Months | |||||||||||||||
30-Sep-14 | ||||||||||||||||
Outstanding Stock Options | 6,651,994 | 6,752,310 | ||||||||||||||
Outstanding Warrants | 194,002 | 275,593 | ||||||||||||||
Restricted Stock Awards | 211,717 | 165,769 | ||||||||||||||
7,057,713 | 7,193,672 | |||||||||||||||
Securities outstanding for the three and nine months ended September 30, 2013 were excluded from the computation of diluted earnings per share because they would have been anti - dilutive. |
Equity_Tables
Equity (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Equity [Abstract] | ' | |||||||||||||||
Stock Options Activity | ' | |||||||||||||||
Activity with respect to the stock options is summarized as follows: | ||||||||||||||||
Number | Weighted- | Weighted-Average | Aggregate | |||||||||||||
of | Average | Remaining | Intrinsic | |||||||||||||
Shares | Exercise | Contractual Term | Value | |||||||||||||
Price | (in years) | |||||||||||||||
Outstanding at January 1, 2014 | 15,375,960 | $ | 2.46 | |||||||||||||
Granted | 2,948,969 | 7.03 | ||||||||||||||
Exercised | (1,146,987 | ) | 1.31 | |||||||||||||
Unvested options forfeited | (249,670 | ) | 4.04 | |||||||||||||
Vested options expired | (84,332 | ) | 0.81 | |||||||||||||
Outstanding at September 30, 2014 | 16,843,940 | 3.32 | 7.5 | $ | 64,630,326 | |||||||||||
Vested at September 30, 2014 | 8,987,368 | 1.87 | 6.7 | 47,252,742 | ||||||||||||
Vested or expected to vest at September 30, 2014 (a) | 16,515,621 | $ | 3.27 | 7.5 | $ | 64,242,362 | ||||||||||
(a) | Includes forfeiture adjusted unvested shares. | |||||||||||||||
Stock Options Outstanding and Exercisable | ' | |||||||||||||||
Following is a summary of stock options outstanding and exercisable at September 30, 2014: | ||||||||||||||||
Options Outstanding | Options Exercisable | |||||||||||||||
Range of Exercise Prices | Number outstanding | Weighted-Average | Weighted- | Number Exercisable | Weighted- | |||||||||||
Remaining | Average | Average | ||||||||||||||
Contractual Term | Exercise | Exercise Price | ||||||||||||||
(in years) | Price | |||||||||||||||
$0.50 - $0.76 | 720,364 | 4.7 | $ | 0.72 | 720,364 | $ | 0.72 | |||||||||
$0.87 - $1.35 | 6,102,250 | 6.9 | 1.2 | 4,911,058 | 1.19 | |||||||||||
$1.40 - $2.29 | 1,482,701 | 5.3 | 1.64 | 1,361,032 | 1.65 | |||||||||||
$2.33 - $3.75 | 1,842,320 | 8 | 2.77 | 889,298 | 2.69 | |||||||||||
$3.95 - $5.99 | 3,443,402 | 8.6 | 5.15 | 911,797 | 5.02 | |||||||||||
$6.02 - $8.34 | 3,252,903 | 9 | 7.03 | 193,819 | 6.37 | |||||||||||
16,843,940 | 7.5 | $ | 3.32 | 8,987,368 | $ | 1.87 | ||||||||||
Fair Value of Options, Valuation Assumptions | ' | |||||||||||||||
The assumptions used in calculating the fair value of options using the Black-Scholes-Merton option-pricing model are set forth in the following table: | ||||||||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | |||||||||||||||
Expected volatility | 63.6- 64.5% | 61.41 - 64.56% | ||||||||||||||
Expected life (in years) | 5.0 - 6.0 | 6 | ||||||||||||||
Expected dividend yield | — | — | ||||||||||||||
Risk-free interest rate | 1.69% - 1.96% | 0.85% -1.88% | ||||||||||||||
Restricted Stock Awards Roll Forward | ' | |||||||||||||||
Activity with respect to restricted stock awards is summarized as follows: | ||||||||||||||||
Number | Weighted-Average Grant Date | |||||||||||||||
of | Fair Value | |||||||||||||||
Shares | ||||||||||||||||
Unvested at December 31, 2013 | 576,550 | $5.53 | ||||||||||||||
Granted | 592,864 | 7.05 | ||||||||||||||
Vested | (154,758 | ) | 5.72 | |||||||||||||
Forfeited | (720 | ) | 7.24 | |||||||||||||
Unvested at September 30, 2014 | 1,013,936 | $6.40 | ||||||||||||||
Allocation of Share-based Compensation | ' | |||||||||||||||
For the three and nine months ended September 30, 2014 and 2013, the Company recognized stock-based compensation as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Cost of sales | $ | 70,424 | $ | 75,287 | $ | 242,689 | $ | 198,119 | ||||||||
Research and development | 170,426 | 110,694 | 493,078 | 309,461 | ||||||||||||
Selling, general and administrative | 2,781,112 | 1,481,785 | 7,424,911 | 3,647,425 | ||||||||||||
$ | 3,021,962 | $ | 1,667,766 | $ | 8,160,678 | $ | 4,155,005 | |||||||||
Summary of Warrants Outstanding | ' | |||||||||||||||
Following is a summary of the warrant activity for the nine months ended September 30, 2014: | ||||||||||||||||
Number | Weighted-Average | |||||||||||||||
of | Exercise Price | |||||||||||||||
Warrants | per warrant | |||||||||||||||
Warrants outstanding at January 1, 2014 | 1,284,816 | $ | 0.9 | |||||||||||||
Warrants exercised | (1,079,583 | ) | 0.8 | |||||||||||||
Warrants outstanding at September 30, 2014 | 205,233 | $ | 1.42 | |||||||||||||
Supplemental_disclosure_of_cas1
Supplemental disclosure of cash flow and non-cash investing and financing activities (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Supplemental Cash Flow Elements [Abstract] | ' | |||||||
Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities | ' | |||||||
Selected cash payments, receipts, and noncash activities are as follows: | ||||||||
Nine Months Ended September 30, | ||||||||
2014 | 2013 | |||||||
Cash paid for interest | $ | 38,347 | $ | 22,971 | ||||
Prepaid income taxes | 80,953 | 96,967 | ||||||
Purchases of equipment financed through capital leases | — | 107,259 | ||||||
Stock issuance of 13,158 shares in exchange for services performed | 86,391 | — | ||||||
Stock issuance of 5,272,004 shares in exchange for convertible debt | — | 5,272,004 | ||||||
Tenant improvement incentive | — | 996,866 | ||||||
Contractual_Commitments_and_Co1
Contractual Commitments and Contingencies (Tables) | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Commitments and Contingencies Disclosure [Abstract] | ' | |||
Estimated Annual Lease, Royalty and Employment Agreement Expenses | ' | |||
In addition to the Capital Leases noted above in Note 5, the Company has entered into operating lease agreements for facility space and equipment. These leases expire over the next five years and generally contain renewal options. The Company anticipates that most of these leases will be renewed or replaced upon expiration. The Company also has commitments for meeting space and to various charitable organizations. The estimated annual lease payments, meeting space and charitable organization commitments are as follows: | ||||
12-month period ended September 30 | ||||
2015 | $ | 1,879,579 | ||
2016 | 1,863,354 | |||
2017 | 1,523,923 | |||
2018 | 1,463,054 | |||
2019 | 478,325 | |||
$ | 7,208,235 | |||
Basis_of_Presentation_Details
Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2014 | |
segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Number of business segments | 1 |
Significant_Accounting_Policie2
Significant Accounting Policies (Details) (Patents [Member], USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Patents [Member] | ' | ' |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Intangible assets, net of accumulated amortization | $477,000 | $527,000 |
Liquidity_and_Managements_Plan1
Liquidity and Management's Plans (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Dec. 31, 2012 |
Liquidity and management's plans [Abstract] | ' | ' | ' | ' |
Cash and cash equivalents | $47,253,003 | $44,077,751 | $6,061,756 | $6,754,485 |
Total current assets | 77,264,455 | 65,388,771 | ' | ' |
Total current liabilities | $14,449,229 | $9,607,867 | ' | ' |
Inventories_Details
Inventories (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $270,191 | $202,414 |
Work in process | 3,228,525 | 2,951,704 |
Finished goods | 1,664,729 | 1,048,886 |
Inventory, gross | 5,163,445 | 4,203,004 |
Reserve for obsolescence | -424,755 | -322,228 |
Inventory, net | $4,738,690 | $3,880,776 |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, gross | $8,218,237 | ' | $8,218,237 | ' | $6,387,976 |
Less accumulated depreciation | -3,166,028 | ' | -3,166,028 | ' | -2,301,870 |
Property and equipment, net | 5,052,209 | ' | 5,052,209 | ' | 4,086,106 |
Capital Leases Interest Rate Effective Percentage Minimum | 3.00% | ' | 3.00% | ' | ' |
Capital Leases Interest Rate Effective Percentage Maximum | 12.00% | ' | 12.00% | ' | ' |
Depreciation | 313,000 | 185,000 | 864,158 | 422,524 | ' |
Leasehold improvements | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, gross | 2,491,731 | ' | 2,491,731 | ' | 2,319,928 |
Lab and clean room equipment | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, gross | 2,804,547 | ' | 2,804,547 | ' | 2,025,263 |
Furniture and office equipment | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, gross | 2,090,776 | ' | 2,090,776 | ' | 1,240,466 |
Construction in progress | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, gross | 831,183 | ' | 831,183 | ' | 802,319 |
Assets Held under Capital Leases | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, net | 427,000 | ' | 427,000 | ' | ' |
Leasehold Improvements Paid by Others | ' | ' | ' | ' | ' |
Property and equipment [Line Items] | ' | ' | ' | ' | ' |
Property and equipment, net | $1,000,000 | ' | $1,000,000 | ' | ' |
Intangible_Assets_and_Royalty_2
Intangible Assets and Royalty Agreement (Details) (USD $) | 3 Months Ended | 9 Months Ended | 9 Months Ended | 0 Months Ended | 9 Months Ended | 9 Months Ended | 9 Months Ended | 9 Months Ended | 9 Months Ended | 9 Months Ended | |||||||||||||||||||||||||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 29, 2007 | Sep. 30, 2014 | Jan. 05, 2011 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Jan. 05, 2011 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 05, 2011 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 05, 2011 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 05, 2011 | Sep. 30, 2014 | Dec. 31, 2013 | |||||||||||||||
Licenses | Licenses | Licenses | Licenses | Licenses | Patents & Know How | Patents & Know How | Patents & Know How | Patents & Know How | Customer & Supplier Relationships | Customer & Supplier Relationships | Customer & Supplier Relationships | Tradenames & Trademarks | Tradenames & Trademarks | Tradenames & Trademarks | In Process Research & Development | In Process Research & Development | In Process Research & Development | Patents in Process | Patents in Process | ||||||||||||||||||||
Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. | Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. | Surgical Biologics, LLC | Surgical Biologics, LLC | Surgical Biologics, LLC | Surgical Biologics, LLC | Surgical Biologics, LLC | Surgical Biologics, LLC | ||||||||||||||||||||||||||||||||
Finite-Lived Intangible Assets [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Weighted Average Amortization Lives | ' | ' | ' | ' | ' | '10 years | [1],[2] | ' | ' | ' | ' | '14 years | [1] | ' | ' | ' | '14 years | [1] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |||||||||||
Gross Carrying Value | ' | ' | ' | ' | ' | $1,009,000 | [1],[2] | $1,009,000 | [1],[2] | ' | ' | $13,000 | $7,888,856 | [1] | $7,798,910 | [1] | ' | $7,690,000 | $3,761,000 | [1] | $3,761,000 | [1] | $3,761,000 | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||
Weighted Average Amortization Lives, Indefinite Lived | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'indefinite | [1] | ' | ' | 'indefinite | [1] | ' | ' | 'indefinite | [3] | ' | |||||||||||
Gross Carrying Value, Indefinite Lived | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,008,000 | [1] | 1,008,000 | [1] | 1,008,000 | 25,000 | [1] | 25,000 | [1] | 25,000 | 967,136 | [3] | 579,987 | [3] | ||||||||
Total | 14,658,992 | ' | 14,658,992 | ' | 14,181,897 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Less Accumulated amortization | -3,698,692 | ' | -3,698,692 | ' | -3,003,324 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Net | 10,960,300 | ' | 10,960,300 | ' | 11,178,573 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Acquisition price | ' | ' | ' | ' | ' | ' | ' | 996,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Maximum time of approval | ' | ' | ' | ' | ' | ' | ' | '30 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Contingent payments to licensor | ' | ' | ' | ' | ' | ' | ' | ' | 200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Contingent royalty to be paid to licensor (in hundredths) | ' | ' | ' | ' | ' | ' | ' | ' | 3.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Annual royalty payment | ' | ' | ' | ' | ' | ' | ' | 50,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Net book value | 9,952,300 | ' | 9,952,300 | ' | ' | ' | ' | ' | 234,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Finite-Lived Intangible Assets, Costs | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 89,946 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Amortization of intangible assets | 232,079 | 259,575 | 695,368 | 789,809 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Estimated future amortization expense [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
2014 | 232,306 | [4] | ' | 232,306 | [4] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||
2015 | 929,226 | ' | 929,226 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
2016 | 929,226 | ' | 929,226 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
2017 | 839,593 | ' | 839,593 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
2018 | 829,626 | ' | 829,626 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Thereafter | 6,192,323 | ' | 6,192,323 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
Net book value | $9,952,300 | ' | $9,952,300 | ' | ' | ' | ' | ' | $234,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ||||||||||||||
[1] | On January 5, 2011, the Company acquired Surgical Biologics, LLC. As a result, the Company recorded intangible assets for Customer & Supplier Relationships of $3,761,000, Patents & Know-How of $7,690,000, Licenses of $13,000, Trade Names & Trademarks of $1,008,000 and In-Process Research & Development of $25,000. For the nine months ended September 30, 2014 an additional $89,946 of costs associated with patents granted during the period were capitalized and included in Patents & Know-How subject to amortization. | ||||||||||||||||||||||||||||||||||||||
[2] | On January 29, 2007, the Company acquired a license from Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. in the amount of $996,000. Within 30 days after the receipt by the Company of approval by the FDA allowing the sale of the first licensed product, the Company is required to pay an additional $200,000 to the licensor. Due to its contingent nature, this amount is not recorded as a liability. The Company will also be required to pay a royalty of 3% on all commercial sales revenue from the licensed products. The Company is also obligated to pay a $50,000 minimum annual royalty payment over the life of the license. As of September 30, 2014, this license had a remaining net book value of approximately $234,000 | ||||||||||||||||||||||||||||||||||||||
[3] | Patents in Process consist of capitalized external legal and other registration costs in connection with internally developed tissue-based patents that are pending. Once issued, the costs associated with a given patent will be included in Patents & Know-How under intangible assets subject to amortization. | ||||||||||||||||||||||||||||||||||||||
[4] | Estimated amortization expense for the year ending December 31, 2014, includes only amortization to be recorded after September 30, 2014. |
Net_Income_Loss_Per_Share_Deta
Net Income (Loss) Per Share (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |||||
Computation of basic and diluted net loss per share [Abstract] | ' | ' | ' | ' | ||||
Net income | $3,699,705 | ($307,118) | $2,387,474 | ($2,684,915) | ||||
Denominator for basic earnings per share - weighted average shares | 105,756,945 | 96,914,856 | 105,331,344 | 95,429,988 | ||||
Effect of dilutive securities: Stock options and warrants outstanding and convertible debt (in shares) | 7,057,713 | [1] | 0 | [1] | 7,193,672 | [1] | 0 | [1] |
Denominator for diluted earnings per share - weighted average shares adjusted for dilutive securities | 112,814,658 | 96,914,856 | 112,525,016 | 95,429,988 | ||||
Income (loss) per common share - basic | $0.03 | $0 | $0.02 | ($0.03) | ||||
Income (loss) per common share - diluted | $0.03 | $0 | $0.02 | ($0.03) | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 7,057,713 | ' | 7,193,672 | ' | ||||
Outstanding Stock Options | ' | ' | ' | ' | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,651,994 | ' | 6,752,310 | ' | ||||
Outstanding Warrants | ' | ' | ' | ' | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 194,002 | ' | 275,593 | ' | ||||
Restricted Stock Awards | ' | ' | ' | ' | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' | ' | ' | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 211,717 | ' | 165,769 | ' | ||||
[1] | Securities outstanding that are included in the computation above, utilizing the treasury stock method for the three and nine months ended September 30, 2014, are as follows:B Three MonthsB Nine MonthsB September 30, 2014Outstanding Stock Options6,651,994B 6,752,310Outstanding Warrants194,002B 275,593Restricted Stock Awards211,717B 165,769B 7,057,713B 7,193,672Securities outstanding for the three and nine months ended September 30, 2013 were excluded from the computation of diluted earnings per share because they would have been anti - dilutive. |
Equity_Details
Equity (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |||
plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ||
Number of share-based compensation plans | ' | ' | 3 | ' | ||
Outstanding assumed options (in shares) | 375,000 | ' | 375,000 | ' | ||
Additional shares authorized by Board of Directors (in shares) | ' | ' | 4,000,000 | ' | ||
Shares authorized (in shares) | 26,500,000 | ' | 26,500,000 | ' | ||
Total unrecognized compensation expense | $16,675,914 | ' | $16,675,914 | ' | ||
Number of shares [Roll forward] | ' | ' | ' | ' | ||
Outstanding, beginning of period (in shares) | ' | ' | 15,375,960 | ' | ||
Granted (in shares) | ' | ' | 2,948,969 | ' | ||
Exercised (in shares) | ' | ' | -1,146,987 | ' | ||
Unvested options forfeited (in shares) | ' | ' | -249,670 | ' | ||
Vested options expired (in shares) | ' | ' | -84,332 | ' | ||
Outstanding, end of period (in shares) | 16,843,940 | ' | 16,843,940 | ' | ||
Vested at end of period (in shares) | 8,987,368 | ' | 8,987,368 | ' | ||
Exercisable options, vested and expected to vest (in shares) | 16,515,621 | [1] | ' | 16,515,621 | [1] | ' |
Weighted-Average Exercise Price [Roll forward] | ' | ' | ' | ' | ||
Outstanding, weighted average exercise price, beginning of period (in dollars per share) | ' | ' | $2.46 | ' | ||
Granted, weighted average exercise price (in dollars per share) | ' | ' | $7.03 | ' | ||
Exercised, weighted average exercise price (in dollars per share) | ' | ' | $1.31 | ' | ||
Unvested options forfeited weighted-average exercise price (in dollars per share) | ' | ' | $4.04 | ' | ||
Vested options expired weighted-average exercise price (in dollars per share) | ' | ' | $0.81 | ' | ||
Outstanding, weighted average exercise price, end of period (in dollars per share) | $3.32 | ' | $3.32 | ' | ||
Vested at end of period weighted average exercise price (in dollars per share) | $1.87 | ' | $1.87 | ' | ||
Vested and expected to vest, weighted average exercise price (in dollars per share) | $3.27 | [1] | ' | $3.27 | [1] | ' |
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Vested at end of period weighted average remaining contractual term | ' | ' | '6 years 8 months 12 days | ' | ||
Vested and expected to vest, weighted average remaining contractual term | ' | ' | '7 years 6 months | [1] | ' | |
Outstanding intrinsic value | 64,630,326 | ' | 64,630,326 | ' | ||
Vested at end of period aggregate intrinsic value | 47,252,742 | ' | 47,252,742 | ' | ||
Vested and expected to vest, aggregate intrinsic value | 64,242,362 | [1] | ' | 64,242,362 | [1] | ' |
Exercised options, intrinsic value | ' | ' | 6,517,614 | ' | ||
Number of outstanding options (in shares) | 16,843,940 | ' | 16,843,940 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '7 years 6 months | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $3.32 | ' | $3.32 | ' | ||
Number of exercisable options (in shares) | 8,987,368 | ' | 8,987,368 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $1.87 | ' | $1.87 | ' | ||
Fair value options valuation assumptions [Abstract] | ' | ' | ' | ' | ||
Expected volatility Minimum | ' | ' | 63.60% | 61.41% | ||
Expected volatility Maximum | ' | ' | 64.50% | 64.56% | ||
Expected life (in years) | ' | ' | ' | '6 years | ||
Expected dividend yield | ' | ' | 0.00% | 0.00% | ||
Risk-free interest rate Minimum | ' | ' | 1.69% | 0.85% | ||
Risk-free interest rate Maximum | ' | ' | 1.96% | 1.88% | ||
Share-based Compensation [Abstract] | ' | ' | ' | ' | ||
Share-based compensation expense | 3,021,962 | 1,667,766 | 8,160,678 | 4,155,005 | ||
Weighted-average grant date fair value for options granted during the period (in dollars per share) | ' | ' | $4.09 | ' | ||
Warrants, term | ' | ' | '5 years | ' | ||
Warrants | ' | ' | ' | ' | ||
Warrants, Number of Warrants [Roll Forward] | ' | ' | ' | ' | ||
Warrants outstanding, beginning of period (in shares) | ' | ' | 1,284,816 | ' | ||
Warrants exercised (in shares) | ' | ' | -1,079,583 | ' | ||
Warrants outstanding, end of period (in shares) | 205,233 | ' | 205,233 | ' | ||
Warrants, Weighted-Average Exercise Price per Warrant [Roll Forward] | ' | ' | ' | ' | ||
Warrants outstanding, beginning of period (in dollars per share) | ' | ' | 0.9 | ' | ||
Warrants exercised (in dollars per share) | ' | ' | 0.8 | ' | ||
Warrants outstanding, end of period (in dollars per share) | 1.42 | ' | 1.42 | ' | ||
Cost of Products Sold | ' | ' | ' | ' | ||
Share-based Compensation [Abstract] | ' | ' | ' | ' | ||
Share-based compensation expense | 70,424 | 75,287 | 242,689 | 198,119 | ||
Research and Development | ' | ' | ' | ' | ||
Share-based Compensation [Abstract] | ' | ' | ' | ' | ||
Share-based compensation expense | 170,426 | 110,694 | 493,078 | 309,461 | ||
Selling, General and Administrative | ' | ' | ' | ' | ||
Share-based Compensation [Abstract] | ' | ' | ' | ' | ||
Share-based compensation expense | 2,781,112 | 1,481,785 | 7,424,911 | 3,647,425 | ||
$0.50 - $0.76 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $0.50 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $0.76 | ' | ||
Number of outstanding options (in shares) | 720,364 | ' | 720,364 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '4 years 8 months 12 days | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $0.72 | ' | $0.72 | ' | ||
Number of exercisable options (in shares) | 720,364 | ' | 720,364 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $0.72 | ' | $0.72 | ' | ||
$0.87 - $1.35 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $0.87 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $1.35 | ' | ||
Number of outstanding options (in shares) | 6,102,250 | ' | 6,102,250 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '6 years 10 months 24 days | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $1.20 | ' | $1.20 | ' | ||
Number of exercisable options (in shares) | 4,911,058 | ' | 4,911,058 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $1.19 | ' | $1.19 | ' | ||
$1.40 - $2.29 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $1.40 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $2.29 | ' | ||
Number of outstanding options (in shares) | 1,482,701 | ' | 1,482,701 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '5 years 3 months 18 days | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $1.64 | ' | $1.64 | ' | ||
Number of exercisable options (in shares) | 1,361,032 | ' | 1,361,032 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $1.65 | ' | $1.65 | ' | ||
$2.33 - $3.75 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $2.35 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $3.75 | ' | ||
Number of outstanding options (in shares) | 1,842,320 | ' | 1,842,320 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '8 years | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $2.77 | ' | $2.77 | ' | ||
Number of exercisable options (in shares) | 889,298 | ' | 889,298 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $2.69 | ' | $2.69 | ' | ||
$3.95 - $5.99 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $3.95 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $5.99 | ' | ||
Number of outstanding options (in shares) | 3,443,402 | ' | 3,443,402 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '8 years 7 months 6 days | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $5.15 | ' | $5.15 | ' | ||
Number of exercisable options (in shares) | 911,797 | ' | 911,797 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $5.02 | ' | $5.02 | ' | ||
$6.02 - $8.34 | ' | ' | ' | ' | ||
Stock options, additional disclosures [Abstract] | ' | ' | ' | ' | ||
Exercise Price Range, lower range limit (in dollars per share) | ' | ' | $6.02 | ' | ||
Exercise Price Range, upper range limit (in dollars per share) | ' | ' | $8.34 | ' | ||
Number of outstanding options (in shares) | 3,252,903 | ' | 3,252,903 | ' | ||
Outstanding Options, weighted average remaining contractual term | ' | ' | '9 years | ' | ||
Outstanding Options, weighted average exercise price (in dollars per share) | $7.03 | ' | $7.03 | ' | ||
Number of exercisable options (in shares) | 193,819 | ' | 193,819 | ' | ||
Exercisable Options, weighted average exercise price (in dollars per share) | $6.37 | ' | $6.37 | ' | ||
Stock Options | ' | ' | ' | ' | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ||
Expenses expected to be recognized over a weighted-average period | ' | ' | '2 years | ' | ||
Restricted Stock Awards | ' | ' | ' | ' | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ||
Expenses expected to be recognized over a weighted-average period | ' | ' | '2 years 1 month 6 days | ' | ||
Total unrecognized stock-based compensation related to time-based, nonvested restricted stock | 4,983,312 | ' | 4,983,312 | ' | ||
Number of Shares | ' | ' | ' | ' | ||
Beginning Balance | ' | ' | 576,550 | ' | ||
Granted | ' | ' | 592,864 | ' | ||
Vested | ' | ' | -154,758 | ' | ||
Forfeited | ' | ' | -720 | ' | ||
Ending Balance | 1,013,936 | ' | 1,013,936 | ' | ||
Weighted- Average Grant Date Fair Value | ' | ' | ' | ' | ||
Beginning Balance (in dollars per share) | ' | ' | $5.53 | ' | ||
Granted (in dollars per share) | ' | ' | $7.05 | ' | ||
Vested (in dollars per share) | ' | ' | $5.72 | ' | ||
Forfeited (in dollars per share) | ' | ' | $7.24 | ' | ||
Beginning Balance (in dollars per share) | $6.40 | ' | $6.40 | ' | ||
Minimum | ' | ' | ' | ' | ||
Fair value options valuation assumptions [Abstract] | ' | ' | ' | ' | ||
Expected life (in years) | ' | ' | '5 years | ' | ||
Maximum | ' | ' | ' | ' | ||
Fair value options valuation assumptions [Abstract] | ' | ' | ' | ' | ||
Expected life (in years) | ' | ' | '6 years | ' | ||
Consultant | ' | ' | ' | ' | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ||
Shares of common stock issued | ' | ' | 5,611 | ' | ||
Value of common stock issued | ' | ' | $39,000 | ' | ||
[1] | Includes forfeiture adjusted unvested shares. |
Income_taxes_Details
Income taxes (Details) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Income Tax Disclosure [Abstract] | ' | ' |
Effective tax rate (as a percentage) | 0.92% | 3.75% |
Supplemental_disclosure_of_cas2
Supplemental disclosure of cash flow and non-cash investing and financing activities (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Supplemental disclosure of cash flow and non-cash investing and financing activities [Abstract] | ' | ' |
Cash paid for interest | $38,347 | $22,971 |
Prepaid income taxes | 80,953 | 96,967 |
Purchases of equipment financed through capital leases | 0 | 107,259 |
Shares issued for services performed | 86,391 | 0 |
Shares issued for services performed (in shares) | 13,158 | 0 |
Stock issuance of 5,272,004 shares in exchange for convertible debt | 0 | 5,272,004 |
Stock issued for convertible debt (in shares) | 0 | 5,272,004 |
Tenant improvement incentive | $0 | $996,866 |
Contractual_Commitments_and_Co2
Contractual Commitments and Contingencies (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
patient | ||||
Loss Contingencies [Line Items] | ' | ' | ' | ' |
Lease expiration period | ' | ' | '5 years | ' |
Rent expense | $282,000 | $364,000 | $847,000 | $762,000 |
Number of patients | ' | ' | 150 | ' |
Estimated annual lease, royalty, and employment agreement expenses [Abstract] | ' | ' | ' | ' |
2015 | 1,879,579 | ' | 1,879,579 | ' |
2016 | 1,863,354 | ' | 1,863,354 | ' |
2017 | 1,523,923 | ' | 1,523,923 | ' |
2018 | 1,463,054 | ' | 1,463,054 | ' |
2019 | 478,325 | ' | 478,325 | ' |
Total Contractual commitments | 7,208,235 | ' | 7,208,235 | ' |
Sales Revenue, Net | Product Concentration Risk | ' | ' | ' | ' |
Loss Contingencies [Line Items] | ' | ' | ' | ' |
Percentage of revenue | ' | ' | 15.00% | ' |
Standby Letters of Credit | ' | ' | ' | ' |
Loss Contingencies [Line Items] | ' | ' | ' | ' |
Standby letters of credit | $500,000 | ' | $500,000 | ' |
Minimum | ' | ' | ' | ' |
Loss Contingencies [Line Items] | ' | ' | ' | ' |
Number of clinical sites | ' | ' | 10 | ' |
Maximum | ' | ' | ' | ' |
Loss Contingencies [Line Items] | ' | ' | ' | ' |
Number of clinical sites | ' | ' | 20 | ' |
Schedule_II_Valuation_and_Qual1
Schedule II - Valuation and Qualifying Accounts (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Mar. 31, 2014 | Mar. 31, 2013 | |
Allowance for doubtful accounts | ' | ' | ' | ' | ' | ' |
Movement in Valuation Allowances and Reserves [Roll Forward] | ' | ' | ' | ' | ' | ' |
Balance at Beginning of Period | ' | ' | $407,000 | $49,000 | $678,000 | $44,000 |
Additions charged to Expense or Revenue | 523,000 | 73,000 | 808,000 | 99,000 | ' | ' |
Deductions and write-offs | 0 | -2,000 | -14,000 | -33,000 | ' | ' |
Balance at End of Period | 1,201,000 | 115,000 | 1,201,000 | 115,000 | 678,000 | 44,000 |
Allowance for product returns | ' | ' | ' | ' | ' | ' |
Movement in Valuation Allowances and Reserves [Roll Forward] | ' | ' | ' | ' | ' | ' |
Balance at Beginning of Period | ' | ' | 215,000 | 88,000 | 270,000 | 162,000 |
Additions charged to Expense or Revenue | 806,000 | 178,000 | 1,419,000 | 648,000 | ' | ' |
Deductions and write-offs | -399,000 | -153,000 | -957,000 | -549,000 | ' | ' |
Balance at End of Period | 677,000 | 187,000 | 677,000 | 187,000 | 270,000 | 162,000 |
Allowance for obsolescence | ' | ' | ' | ' | ' | ' |
Movement in Valuation Allowances and Reserves [Roll Forward] | ' | ' | ' | ' | ' | ' |
Balance at Beginning of Period | ' | ' | 322,000 | 159,000 | 352,000 | 242,000 |
Additions charged to Expense or Revenue | 76,000 | 131,000 | 140,000 | 214,000 | ' | ' |
Deductions and write-offs | -3,000 | 0 | -37,000 | 0 | ' | ' |
Balance at End of Period | $425,000 | $373,000 | $425,000 | $373,000 | $352,000 | $242,000 |