Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 17, 2018 | Jun. 30, 2017 | |
Document and Entity Information | |||
Entity Registrant Name | ROCKWELL MEDICAL, INC. | ||
Entity Central Index Key | 1,041,024 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 330,268,000 | ||
Entity Common Stock, Shares Outstanding | 51,768,424 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
ASSETS | ||
Cash and Cash Equivalents | $ 8,406,917 | $ 17,180,594 |
Investments available for sale | 24,648,459 | 40,759,703 |
Accounts Receivable, net of a reserve of $6,000 in 2017 and $5,000 in 2016 | 6,355,566 | 6,393,228 |
Inventory | 7,637,384 | 12,141,072 |
Other Current Assets | 1,779,992 | 2,034,598 |
Total Current Assets | 48,828,318 | 78,509,195 |
Property and Equipment, net | 2,548,978 | 1,391,575 |
Inventory, Non-Current | 5,986,752 | 1,826,554 |
Intangible Assets | 4,028 | 4,382 |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 490,819 | 501,187 |
Total Assets | 58,779,640 | 83,153,638 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Accounts Payable | 4,222,159 | 5,858,234 |
Accrued Liabilities | 4,715,712 | 4,210,151 |
Customer Deposits | 205,303 | 77,217 |
Total Current Liabilities | 9,143,174 | 10,145,602 |
Deferred License Revenue | 16,723,318 | 20,051,737 |
Shareholders' Equity: | ||
Common Shares, no par value, 51,761,040 and 51,527,711 shares issued and outstanding | 273,210,907 | 268,199,939 |
Accumulated Deficit | (240,262,376) | (214,341,092) |
Accumulated Other Comprehensive Income | (35,383) | (902,548) |
Total Shareholders' Equity | 32,913,148 | 52,956,299 |
Total Liabilities And Shareholders' Equity | $ 58,779,640 | $ 83,153,638 |
Consolidated Balance Sheets Par
Consolidated Balance Sheets Parenthetical) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
CONSOLIDATED BALANCE SHEETS | ||
Allowance for reserve, accounts receivable (in dollars) | $ 11,000 | $ 5,000 |
Common Shares, par value (in dollars per share) | $ 0 | $ 0 |
Common Shares, shares issued | 51,768,424 | 51,527,711 |
Common Shares, shares outstanding | 51,768,424 | 51,527,711 |
Consolidated Income Statements
Consolidated Income Statements - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CONSOLIDATED INCOME STATEMENTS | |||
Sales | $ 57,300,281 | $ 53,284,166 | $ 55,350,702 |
Cost of Sales | 53,598,390 | 46,531,648 | 46,412,848 |
Gross Profit | 3,701,891 | 6,752,518 | 8,937,854 |
Selling, General and Administrative | 23,303,409 | 21,120,901 | 19,078,867 |
Research and Product Development | 6,321,400 | 5,840,346 | 4,961,313 |
Operating Income (Loss) | (25,922,918) | (20,208,729) | (15,102,326) |
Interest and Investment Income, net | 892 | 810,340 | 681,876 |
Foreign Currency Gain (Loss) | 742 | ||
Income (Loss) Before Income Taxes | (25,921,284) | (19,398,389) | (14,420,450) |
Income Tax Expense | 0 | 404,527 | 0 |
Net Income (Loss) | $ (25,921,284) | $ (19,802,916) | $ (14,420,450) |
Basic Earnings (Loss) per Share | $ (0.51) | $ (0.39) | $ (0.29) |
Diluted Earnings (Loss) per Share | $ (0.51) | $ (0.39) | $ (0.29) |
Consolidated Statements Of Comp
Consolidated Statements Of Comprehensive Income (Loss) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | |||
Net Income (Loss) | $ (25,921,284) | $ (19,802,916) | $ (14,420,450) |
Unrealized Gain (Loss) on Available-For-Sale Securities | 866,031 | 13,619 | (717,827) |
Foreign Currency Translation Adjustments | 1,134 | (671) | |
Comprehensive Income (Loss) | $ (25,054,119) | $ (19,789,968) | $ (15,138,277) |
Consolidated Statements Of Chan
Consolidated Statements Of Changes In Shareholders' Equity - USD ($) | COMMON SHARES | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | Total |
Balance at Dec. 31, 2014 | $ 249,018,189 | $ (180,117,726) | $ (197,669) | $ 68,702,794 |
Balance (in shares) at Dec. 31, 2014 | 50,284,007 | |||
Increase (Decrease) in Shareholders' Equity | ||||
Net Loss | (14,420,450) | (14,420,450) | ||
Unrealized Gain (Loss) on Available-For-Sale Securities | (717,827) | (717,827) | ||
Issuance of Common Shares | $ 4,132,250 | 4,132,250 | ||
Issuance of Common Shares (in shares) | 1,644,248 | |||
Stock Option Based Expense | $ 5,193,481 | 5,193,481 | ||
Stock Tendered in Satisfaction of Tax Liabilities | $ (4,264,922) | (4,264,922) | ||
Stock Tendered in Satisfaction of Tax Liabilities (in shares) | (426,378) | |||
Restricted Stock Amortization | $ 3,694,496 | 3,694,496 | ||
Balance at Dec. 31, 2015 | $ 257,773,494 | (194,538,176) | (915,496) | $ 62,319,822 |
Balance (in shares) at Dec. 31, 2015 | 51,501,877 | 51,501,877 | ||
Increase (Decrease) in Shareholders' Equity | ||||
Net Loss | (19,802,916) | $ (19,802,916) | ||
Unrealized Gain (Loss) on Available-For-Sale Securities | 13,619 | 13,619 | ||
Foreign Currency Translation Adjustments | (671) | (671) | ||
Issuance of Common Shares | $ 80,161 | 80,161 | ||
Issuance of Common Shares (in shares) | 25,834 | |||
Stock Option Based Expense | $ 5,984,524 | 5,984,524 | ||
Restricted Stock Amortization | 4,361,760 | 4,361,760 | ||
Balance at Dec. 31, 2016 | $ 268,199,939 | (214,341,092) | (902,548) | $ 52,956,299 |
Balance (in shares) at Dec. 31, 2016 | 51,527,711 | 51,527,711 | ||
Increase (Decrease) in Shareholders' Equity | ||||
Net Loss | (25,921,284) | $ (25,921,284) | ||
Unrealized Gain (Loss) on Available-For-Sale Securities | 866,031 | 866,031 | ||
Foreign Currency Translation Adjustments | 1,134 | 1,134 | ||
Issuance of Common Shares | $ 123,603 | 123,603 | ||
Issuance of Common Shares (in shares) | 508,384 | |||
Shares Issued in Exchange for Services | $ 228,847 | 228,847 | ||
Shares Issued in Exchange for Services (in shares) | 50,000 | |||
Stock Option Based Expense | $ 3,858,502 | 3,858,502 | ||
Stock Tendered in Satisfaction of Tax Liabilities | $ (2,287,231) | (2,287,231) | ||
Stock Tendered in Satisfaction of Tax Liabilities (in shares) | (317,671) | |||
Restricted Stock Amortization | $ 3,087,247 | 3,087,247 | ||
Balance at Dec. 31, 2017 | $ 273,210,907 | $ (240,262,376) | $ (35,383) | $ 32,913,148 |
Balance (in shares) at Dec. 31, 2017 | 51,768,424 | 51,768,424 |
Consolidated Statements Of Cash
Consolidated Statements Of Cash Flow - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash Flows From Operating Activities: | |||
Net (Loss) | $ (25,921,284) | $ (19,802,916) | $ (14,420,450) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | |||
Depreciation and Amortization | 514,362 | 762,368 | 822,294 |
Share Based Compensation - Non-employee | 228,847 | ||
Share Based Compensation- Employees | 6,945,749 | 10,346,284 | 8,887,977 |
Restricted Stock Retained in Satisfaction of Tax Liabilities | (2,287,231) | (2,912,859) | |
Loss on Disposal of Assets | 10,777 | 8,168 | 5,281 |
Loss (gain) on Sale of Investments Available for Sale | 792,207 | 26,820 | 58,095 |
Changes in Assets and Liabilities: | |||
(Increase) Decrease in Accounts Receivable | (962,338) | (1,162,469) | (574,731) |
(Increase) in Inventory | 343,490 | (6,095,846) | (3,951,595) |
(Increase) in Other Assets | 264,975 | (1,230,084) | (360,303) |
Increase (Decrease) in Accounts Payable | (1,636,840) | 1,863,018 | (1,299,299) |
Increase (Decrease) in Other Liabilities | 634,238 | 191,134 | (413,652) |
Increase (decrease) Deferred License Revenue | (2,099,028) | (2,065,785) | (2,081,668) |
Increase (decrease) in Deferred International Partnership Revenue | (229,390) | 4,706,670 | |
Changes in Assets and Liabilities | (3,684,893) | (3,793,362) | (8,681,248) |
Cash (Used In) Operating Activities | (21,114,235) | (12,452,638) | (13,328,051) |
Cash Flows From Investing Activities: | |||
Purchase of Securities Available for Sale | 35,733,677 | 25,781,853 | 21,800,000 |
Sale of Investments Available for Sale | 51,918,745 | 24,491,677 | 1,468,656 |
Purchase of Equipment | (1,682,913) | (355,264) | (815,002) |
Proceeds on Sale of Assets | 725 | 1,000 | 4,800 |
Cash Provided by Investing Activities | 14,502,880 | (1,644,440) | (21,141,546) |
Cash Flows From Financing Activities: | |||
Proceeds from the Issuance of Common Shares and Purchase Warrants | 123,603 | 80,161 | 2,780,187 |
Cash Provided By (Used In) Financing Activities | (2,163,628) | 80,161 | (132,672) |
Effects of exchange rate changes | 1,306 | (671) | |
(Decrease) In Cash | (8,773,677) | (14,017,588) | (34,602,269) |
Cash At Beginning Of Period | 17,180,594 | 31,198,182 | 65,800,451 |
Cash At End Of Period | $ 8,406,917 | 17,180,594 | $ 31,198,182 |
Supplemental Cash Flow Information: | |||
Income Taxes Paid | $ 404,527 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2017 | |
Description of Business | |
Description of Business | 1. DESCRIPTION OF BUSINESS |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
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 subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. Rockwell Medical India Private Limited was formed in 2016 for the purpose of conducting certain commercial activities in India. All intercompany balances and transactions have been eliminated in consolidation. Revenue Recognition Our policy is to recognize revenue consistent with authoritative guidance for revenue recognition including the provisions of the Financial Accounting Standards Board Accounting Standards Codification. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. Consistent with these guidelines we recognize revenue at the time we transfer title to our products to our customers which generally occurs 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 apply judgment as we analyze each element of our contractual agreements to determine appropriate revenue recognition. The terms of our contractual agreements may include milestone payments if specified research and development objectives are achieved, non-refundable licensing fees, milestone payments on sales or royalties from product sales. When entering into an arrangement, we first determine whether the arrangement includes multiple deliverables and is subject to the accounting guidance in ASC subtopic 605-25, Multiple-Element Arrangements. If we determine that an arrangement includes multiple elements, we determine whether the arrangement should be divided into separate units of accounting and how the arrangement consideration should be measured and allocated among the separate units of accounting. An element qualifies as a separate unit of accounting when the delivered element has standalone value to the customer. Our arrangements do not include a general right of return relative to delivered elements. Any delivered elements that do not qualify as separate units of accounting are combined with other undelivered elements within the arrangement as a single unit of accounting. If the arrangement constitutes a single combined unit of accounting, we determine the revenue recognition method for the combined unit of accounting and recognize the revenue either on a straight-line basis or on a modified proportional performance method over the period from inception through the date the last deliverable within the single unit of accounting is delivered. Non-refundable upfront license fees are recorded as deferred revenue and recognized into revenue over the estimated period of our substantive performance obligations. If we do not have substantive performance obligations, we recognize non-refundable upfront fees into revenue through the date the deliverable is satisfied. Analyzing the arrangement to identify deliverables requires the use of judgment and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. In arrangements that include license rights and other non-contingent deliverables, such as participation in a steering committee, these deliverables do not have standalone value because the non-contingent deliverables are dependent on the license rights. That is, the non-contingent deliverables would not have value without the license rights, and only we can perform the related services. Upfront license rights and non-contingent deliverables, such as participation in a steering committee, do not have standalone value as they are not sold separately and they cannot be resold. In addition, when non-contingent deliverables are sold with upfront license rights, the license rights do not represent the culmination of a separate earnings process. As such, we account for the license and the non-contingent deliverables as a single combined unit of accounting. In such instances, the license revenue in the form of non-refundable upfront payments is deferred and recognized over the applicable relationship period. For milestone payments based on sales and for royalties based on sales, we recognize revenue in the quarter that the information related to the sales becomes available and collectability is reasonably assured. We recognize drug licensing fees over the term of the related license agreement. We received an upfront payment of $4 million pursuant to our license agreement with Wanbang Biopharmaceutical Co., Ltd. (“Wanbang”), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Deferred drug license revenue for our drug license agreement is being recognized over the term of those license agreements and we recognized drug license revenue of $0.2 million in 2017. The initial payment of $20 million received pursuant to our long-term Exclusive Distribution Agreement (the “Distribution Agreement”) with Baxter Healthcare Corporation (“Baxter”) in October 2014 has been accounted for as deferred license revenue. Deferred license revenue is being recognized based on the proportion of product shipments to Baxter in each period to total expected sales volume for the term of the agreement. We recognize other revenues at the time the related fees and or payments are earned. Shipping and Handling Revenue and Costs Our products are generally priced on a delivered basis with the price of delivery included in the overall price of our products which is reported as sales. Separately identified freight and handling charges are also included in sales. We include shipping and handling costs, including expenses of Rockwell Transportation, Inc., in cost of sales. Cash and Cash Equivalents We consider cash on hand, money market funds and unrestricted certificates of deposit 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 principally 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). 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. Management evaluates securities for other-than-temporary impairment (“OTTI”) on a quarterly basis, and more frequently when conditions warrant such an evaluation. When evaluating investment securities, consideration is given to the length of time and the extent to which the fair value has been less than cost, the financial condition and near-term prospects of the issuer, and whether the Company has the intent to sell the security or more likely than not will be required to sell the security before its anticipated recovery. The assessment of whether an OTTI exists involves a high degree of subjectivity and judgment and is based on the information available to management at a point in time. Accounts Receivable Accounts receivable are stated at invoice amounts. The carrying amount of trade accounts receivable is reduced by an allowance for doubtful accounts that reflects our best estimate of accounts that may not be collected. We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience. All accounts or portions thereof deemed to be uncollectible are written off to the allowance for doubtful accounts. Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined on the first‑in first‑out (FIFO) method. Inventory that is not expected to be converted to cash over the next year is classified as non-current. Our policy is to reserve for our drug product inventory that we determine is unlikely to be sold to, or if sold, unlikely to be utilized by our customers on or before its expiration date. Property and Equipment Property and equipment are recorded at cost. Expenditures for normal maintenance and repairs are charged to expense as incurred. Property and equipment are depreciated using the straight‑line method over their useful lives, which range from three to ten years. Leasehold improvements are amortized using the straight‑line method over the shorter of their useful lives or the related lease term. Licensing Fees License fees related to the technology, intellectual property and marketing rights for Triferic covered under certain issued patents have been capitalized and are being amortized over the life of the related patents which is generally 17 years. Goodwill, Intangible Assets and Long Lived Assets The recorded amounts of goodwill and other intangibles from prior business combinations are based on management’s best estimates of the fair values of assets acquired and liabilities assumed at the date of acquisition. Goodwill is not amortized; however, it must be tested for impairment at least annually. Amortization continues to be recorded for other intangible assets with definite lives over their estimated useful lives. Intangible assets subject to amortization are reviewed for potential impairment whenever events or circumstances indicate that carrying amounts may not be recoverable. An impairment review of goodwill, intangible assets, and property and equipment is performed annually or whenever a change in condition occurs which indicates that the carrying amounts of assets may not be recoverable. Such changes may include changes in our business strategies and plans, changes to our customer contracts, changes to our product lines and changes in our operating practices. We use a variety of factors to assess the realizable value of long‑lived assets depending on their nature and use. The useful lives of other intangible assets are based on management’s best estimates of the period over which the assets are expected to contribute directly or indirectly to our future cash flows. Management annually evaluates the remaining useful lives of intangible assets with finite useful lives to determine whether events and circumstances warrant a revision to the remaining amortization periods. It is reasonably possible that management’s estimates of the carrying amount of goodwill and the remaining useful lives of other intangible assets may change in the near term. Income Taxes We account for income taxes in accordance with the provisions of ASC 740‑10, Income Taxes. A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between book and tax accounting and operating loss and tax credit carryforwards. A valuation allowance is established for deferred tax assets if we determine it to be more likely than not that the deferred tax asset will not be realized. The effects of tax positions are generally recognized in the financial statements consistent with amounts reflected in returns filed, or expected to be filed, with taxing authorities. For tax positions that the Company considers to be uncertain, current and deferred tax liabilities are recognized, or assets derecognized, when it is probable that an income tax liability has been incurred and the amount of the liability is reasonably estimable, or when it is probable that a tax benefit, such as a tax credit or loss carryforward, will be disallowed by a taxing authority. The amount of unrecognized tax benefits related to current tax positions is insignificant. The Company recognizes interest and penalties accrued related to unrecognized tax benefits as income tax expense. Research and Product Development We recognize research and product development costs as expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including Triferic and for other indications of Triferic, aggregating approximately $6,321,000, $5,840,000 and $4,961,000 in 2017, 2016 and 2015, respectively. Share Based Compensation We measure the cost of employee services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards in accordance with ASC 718‑10, Compensation — Stock Compensation. The cost of equity based compensation is recognized as compensation expense over the vesting period of the awards. We estimate the fair value of compensation involving stock options utilizing the Black‑Scholes option pricing model. This model requires the input of several factors such as the expected option term, expected volatility of our stock price over the expected option term, and an expected forfeiture rate, and is subject to various assumptions. We believe the valuation methodology is appropriate for estimating the fair value of stock options we grant to employees and directors which are subject to ASC 718‑10 requirements. These amounts are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. Employee Retirement Plans We are the sponsor of a non‑contributory 401(k) Employee Savings Plan. Earnings per Share We compute 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. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: 2017 2016 2015 Basic Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 Effect of Dilutive Securities — — — Diluted Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 For 2017, 2016 and 2015, the dilutive effect of stock options, unvested restricted share grants and common share purchase warrants have not been included in the average shares outstanding for the calculation of diluted loss per share as the effect would be anti-dilutive as a result of our net loss in these periods. The table below summarizes potentially dilutive securities. 2017 2016 2015 Stock Options 6,906,001 7,691,501 7,759,002 Range of Exercise Prices of Stock Options $3.09 - $11.49 $3.09 - $11.49 $3.09 - $11.49 Unvested Restricted Common Shares 480,000 850,000 850,000 Other Comprehensive Income (Loss) Accounting principles generally require that recognized revenue, expenses, gains, and losses be included in net income. Certain changes in assets and liabilities, however, such as unrealized gains and losses on available for sale securities, are reported as a direct adjustment to the equity section of the balance sheet. Such items, along with net income (loss), are considered components of comprehensive income (loss). Accumulated Other Comprehensive Income (Loss) consists almost entirely of unrealized gains and losses on available‑for‑sale investment securities. We also record foreign currency translation adjustments to Other Comprehensive Income (Loss). However, such amounts were insignificant in 2017. Estimates in Preparation of Financial Statements The preparation of financial statements in conformity with generally accepted accounting principles requires management to make certain 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 reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. New Accounting Pronouncements In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which will supersede the current revenue recognition requirements in Topic 605, Revenue Recognition . The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The new guidance is effective for the year beginning January 1, 2018. The standard permits the use of either the retrospective or cumulative effect transition method. The Company has evaluated the impact of the new standard and has elected the cumulative effect transition method. The adoption of the standard will not have a material impact on our financial position or results of operations. We have finalized and implemented our accounting policy and our internal controls under the new standard without significant issues. The new standard will also require expanded disclosures surrounding revenue in the notes to the financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . The amendments in this ASU revise the accounting related to lessee accounting. Under the new guidance, lessees will be required to recognize a lease liability and a right-of-use asset for all leases. The amendments in this ASU are effective for the Company beginning on January 1, 2019 and should be applied through a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. We anticipate this standard will have a material impact on our consolidated balance sheets. However, we do not believe adoption will have a material impact on our consolidated income statements. Upon implementation, the Company's lease payment obligations will be recognized at their estimated present value along with a corresponding right-of-use asset. Lease expense recognition will be generally consistent with current practice. |
Fair Market Value Measurements
Fair Market Value Measurements | 12 Months Ended |
Dec. 31, 2017 | |
FAIR MARKET VALUE MEASUREMENTS | |
FAIR MARKET VALUE MEASUREMENTS | 3. FAIR MARKET VALUE MEASUREMENTS Accounting standards require certain assets and liabilities be reported at fair value in the financial statements and provides a framework for establishing that fair value. The framework for determining fair value is based on a hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted in active markets, but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considering counterparty credit risk in its assessment of fair value. The following methods, assumptions, and valuation techniques were used to measure different financial assets and liabilities at fair value and in estimating its fair value disclosures for financial instruments. Cash and Cash Equivalents: The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents are deemed to approximate fair value Investment Securities: Fair values for investment securities are determined by quoted market prices if available. Accounts Receivable, Accounts Payable and Accrued Liabilities: The fair value of trade receivables and payables approximate their carrying amounts due to the short duration before collection or payment. Based on the foregoing methods and assumptions, the carrying value and fair value of the Company’s financial instruments other than trade receivables and payables are as follows (in thousands): Carrying value Fair value Level 1 Level 2 Level 3 As of December 31, 2017 Financial assets Cash and cash equivalents $ 8,407 $ 8,407 $ 8,407 $ — $ — Investment securities available for sale 24,648 24,648 24,648 — — As of December 31, 2016 Financial assets Cash and cash equivalents $ 17,181 $ 17,181 $ 17,181 $ — $ — Investment securities available for sale 40,760 40,760 40,760 — — The Company also has certain non‑financial assets that under certain conditions are subject to measurement at fair value on a non‑recurring basis. No such measurements were required in 2017 or 2016. |
Investments in Available For Sa
Investments in Available For Sale Securities | 12 Months Ended |
Dec. 31, 2017 | |
INVESTMENTS IN AVAILABLE FOR SALE SECURITIES | |
INVESTMENTS IN AVAILABLE FOR SALE SECURITIES | 4. INVESTMENTS IN AVAILABLE FOR SALE SECURITIES As of December 31, 2017, we held investments in available for sale securities with a market value of $24,648,459. These investments consisted primarily of high quality short term debt instruments. These debt instruments were subject to changes in fair market value due to changes in interest rates. In 2017, we repositioned our investment portfolio and sold securities with a market value of $51,918,745 with an average cost basis of $52,711,407. In 2017, we had realized gains of $12,927 and realized losses of $805,134. As of December 31, 2016, we held investments in available for sale securities in several short term bond funds. These funds generally held high credit quality short term debt instruments. These debt instruments were subject to changes in fair market value due to changes in interest rates. The market value of these investments was $40,759,703 as of December 31, 2016. In 2016, we purchased securities with a market value of $25,781,853 and had unrealized losses of $901,877 as of December 31, 2016. In 2016, we sold securities with a market value of $24,491,677 with an average cost basis of $24,518,497. We had realized gains of $156,461 and realized losses of $183,281. |
Significant Market Segments And
Significant Market Segments And Customers | 12 Months Ended |
Dec. 31, 2017 | |
SIGNIFICANT MARKET SEGMENTS | |
SIGNIFICANT MARKET SEGMENTS AND CUSTOMERS | 5. SIGNIFICANT MARKET SEGMENTS AND CUSTOMERS We operate in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. In October 2014, we entered into the Distribution Agreement with Baxter, which was amended in June 2017, pursuant to which Baxter received exclusive distribution rights for our concentrate products in the United States. Our domestic customer contracts for the supply of dialysis concentrate products that permitted assignment to Baxter without consent have been assigned to Baxter. As a result, for 2017, 2016 and 2015, our direct sales to Baxter aggregated approximately 27%, 24% and 28% of sales, respectively, and we had a receivable from Baxter of $1,863,412 and $2,430,159 as of December 31, 2017 and 2016, respectively. One customer, DaVita Healthcare Partners, Inc., accounted for 50% of our sales in 2017, 52% of our sales in 2016 and 48% of our sales in 2015. Our accounts receivable from this customer were $2,411,367 and $2,224,046 as of December 31, 2017 and 2016, respectively. DaVita and Baxter and the accounts administered by Baxter are important to our business, financial condition and results of operations. The loss of any significant accounts could have a material adverse effect on our business, financial condition and results of operations. No other customers accounted for more than 10% of our sales in any of the last three years. The majority of our international sales in each of the last three years were sales to domestic distributors that were resold to end users outside the United States. Our sales directly to foreign customers and distributors accounted for less than 5% of our total sales in 2017, 2016 and 2015. Our total international sales, including sales made through domestic distributors for resale outside the United States, aggregated 12%, 12% and 13%, of our overall sales in 2017, 2016 and 2015, respectively. |
Distribution Agreement
Distribution Agreement | 12 Months Ended |
Dec. 31, 2017 | |
DISTRIBUTION AGREEMENT. | |
DISTRIBUTION AGREEMENT | 6. DISTRIBUTION AGREEMENT As of October 2, 2014, we entered into the Distribution Agreement with Baxter, pursuant to which Baxter became our exclusive agent for sales, marketing and distribution activities for our hemodialysis concentrate and ancillary products in the United States and various foreign countries for an initial term of 10 years ending on October 2, 2024. The Distribution Agreement does not include any of our drug products. We will retain sales, marketing and distribution rights for our hemodialysis concentrate products in specified foreign countries in which we have an established commercial presence. During the term of the Distribution Agreement, Baxter has agreed not to manufacture or sell any competitive concentrate products in the United States hemodialysis market, other than specified products. Pursuant to the Distribution Agreement, Baxter paid us $20 million in cash in October 2014 (the “Upfront Fee”). The Upfront Fee has been deferred and is being recognized as revenue based on the proportion of product shipments to Baxter in each period to total expected sales volume over the term of the Distribution Agreement. We recognized revenue associated with the Upfront Fee totaling $2,099,028 for the year ended December 31, 2017, $2,065,785 for the year ended December 31, 2016 and $2,081,668 for the year ended December 31, 2015. Under the Distribution Agreement, Baxter purchases products from us at established gross margin-based prices per unit, adjusted each year during the term. We continue to manage customer service, transportation and certain other functions for our current customers on Baxter’s behalf, in exchange for which Baxter will pay us an amount equal to our related costs to provide such functions plus a slight mark-up. The Distribution Agreement also requires Baxter to meet minimum annual gallon-equivalent purchase levels, subject to a cure period and certain other relief, in order to maintain its exclusive distribution rights. The minimum purchase levels increase each year over the term of the Distribution Agreement. Orders in any contract year that exceed the minimum will be carried forward and applied to future years’ minimum requirements. The Distribution Agreement also contains provisions governing the operating relationship between the parties, our obligations to maintain specified manufacturing capacity and quality levels, remedies, as well as representations, warranties and indemnification obligations of the parties. Either party may terminate the Distribution Agreement upon the insolvency or material breach of the other party or in the event of a force majeure. In addition, Baxter may also terminate the Distribution Agreement at any time upon 270 days’ prior written notice to us or if (1) prices increase beyond certain thresholds and notice is provided within 45 days after the true up payment is due for the year in which the price threshold is exceeded, (2) a change of control of the Company occurs and 270 days’ notice is provided, or (3) upon written notice that Baxter has been enjoined by a court of competent jurisdiction from selling in the United States any product covered by the Distribution Agreement due to a claim of intellectual property infringement or misappropriation relating to such product. If Baxter terminates the Distribution Agreement under the discretionary termination or the price increase provisions, it would be subject to a limited non-compete obligation in the United States with respect to certain products for a period of two years. If a “Refund Trigger Event” occurs, we would be obligated to repay a portion of the Upfront Fee and Facility Fee (described below) as follows: 33% if the event occurs in 2018, and 25% if the event occurs in 2019, 2020 or 2021. A “Refund Trigger Event” means any of the following: (1) a change of control of the Company involving any of certain specified companies; (2) a termination by Baxter due to the Company’s bankruptcy or breach, or due to price increases that exceed the stated thresholds; (3) a termination by either party due to a force majeure; (4) settlement or adjudication of any claim, action or litigation relating to a covered product that materially and adversely affects Baxter’s commercialization of the product; and (5) any regulatory action or ruling relating to a covered product that materially and adversely affects Baxter’s commercialization of the product. In addition, if Baxter terminates the Distribution Agreement because Baxter has been enjoined by a court of competent jurisdiction from selling in the United States any product covered by the Distribution Agreement due to a claim of intellectual property infringement or misappropriation relating to such product prior to the end of 2018, Baxter would be entitled to a refund of up to $10 million, or $6.6 million if the termination occurs in 2019. In no event would Baxter be entitled to more than one refund payment. The Distribution Agreement also required us to prepay our outstanding secured long-term indebtedness within 180 days and prohibits us from entering into a subsequent contract encumbering the assets used in our concentrate business without the prior written consent of Baxter. The Distribution Agreement may be extended an additional five years by Baxter if Baxter achieves a specified sales target and pays an extension fee of $7.5 million. If the first extension occurs, the Distribution Agreement term may later be extended an additional five years at Baxter’s option at no additional cost. On September 12, 2016, Baxter initiated an arbitration proceeding against us under the Distribution Agreement alleging various breaches of the Distribution Agreement, and we counterclaimed alleging various breaches by Baxter. On June 23, 2017, we settled the arbitration with Baxter (the “Settlement”). The Settlement included a mutual release with respect to all known claims existing on the date of the Settlement and the arbitration was dismissed with prejudice. No payments were made by either party in connection with the Settlement. In connection with the Settlement, on June 23, 2017, we entered into a First Amendment to Exclusive Distribution Agreement and a First Amendment to Investment Agreement, in each case, with Baxter. The terms of the Settlement included, among other things, reduced pricing on certain accounts that provides incentive to Baxter to pursue new customers and increase future sales. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2017 | |
Inventory | |
Inventory | 7. INVENTORY Components of inventory as of December 31, 2017 and 2016 are as follows: December 31, December 31, 2017 2016 Raw Materials $ 10,604,232 $ 10,903,084 Work in Process 212,505 86,452 Finished Goods 2,807,399 2,978,090 Total $ 13,624,136 $ 13,967,626 As of December 31, 2017, we classified $5,986,752 of inventory as non-current all of which related to the active pharmaceutical ingredient for Triferic. |
Property And Equipment
Property And Equipment | 12 Months Ended |
Dec. 31, 2017 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 8. PROPERTY AND EQUIPMENT Major classes of property and equipment, stated at cost, as of December 31, 2017 and 2016 are as follows: 2017 2016 Leasehold Improvements $ 824,087 $ 728,151 Machinery and Equipment 7,893,566 7,169,223 Information Technology & Office Equipment 2,327,524 2,293,587 Laboratory Equipment 631,666 610,767 Transportation Equipment 242,277 265,198 11,919,120 11,066,926 Accumulated Depreciation (9,370,142) (9,675,351) Net Property and Equipment $ 2,548,978 $ 1,391,575 Below is a summary of depreciation expense by period: 2017 2016 2015 Depreciation expense $ 514,009 $ 601,093 $ 655,265 |
Goodwill And Intangible Assets
Goodwill And Intangible Assets | 12 Months Ended |
Dec. 31, 2017 | |
GOODWILL AND INTANGIBLE ASSETS | |
GOODWILL AND INTANGIBLE ASSETS | 9. GOODWILL AND INTANGIBLE ASSETS Total goodwill was $920,745 at December 31, 2017 and 2016. We completed our annual impairment tests as of November 30, 2017 and 2016, and determined that no adjustment for impairment of goodwill was required. We have entered into a global licensing agreement for certain patents covering Triferic, a therapeutic drug compound to be delivered using our dialysate product lines. We received FDA approval for this product in January 2015. We have capitalized the licensing fees paid for the rights to use this patented technology as an intangible asset. We have capitalized certain patent approval costs. During 2011, we acquired an abbreviated new drug application (“ANDA”) for a generic version of an intravenous vitamin‑D analogue, Calcitriol. Total capitalized costs related to this ANDA were approximately $695,000. These were amortized over a five year period ending December 31, 2016. 2017 2016 2015 Capitalized Licensing Fees $ 1,070,126 $ 1,070,126 $ 1,070,126 Accumulated Amortization (1,066,098) (1,065,744) (904,469) Capitalized Licensing Fees, Net of Amortization $ 4,028 $ 4,382 $ 165,657 Amortization Expense $ 353 $ 161,275 $ 167,029 Our policy is to amortize licensing fees over the life of the patents pertaining to certain licensing agreements and to amortize patent costs over the life of the patent. Estimated amortization expense for amortization of capitalized patent costs in 2018 is approximately $353. In 2015, we recognized expenses related to milestone achievements of $275,000. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
ACCRUED LIABILITIES | |
ACCRUED LIABILITIES | 10. ACCRUED LIABILITIES We had the following accrued liabilities as of December 31, 2017 and 2016: 2017 2016 Accrued Research & Development Expense $ 400,024 $ 193,638 Accrued Compensation and Benefits 1,991,874 2,002,767 Other Accrued Liabilities 2,323,814 2,013,746 Total Accrued Liabilities $ 4,715,712 $ 4,210,151 |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2017 | |
OPERATING LEASES | |
OPERATING LEASES | 11. OPERATING LEASES We lease our production facilities and administrative offices as well as certain equipment used in our operations including leases on transportation equipment used in the delivery of our products. The lease terms range from monthly to seven years. We occupy a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2018. We also occupy a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2020. In addition, we lease a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2020. 2017 2016 2015 Rent Expense Recognized Under Operating Leases $ 2,463,145 $ 2,369,101 $ 2,301,930 Future minimum rental payments under operating lease agreements are as follows: Year ending December 31, 2018 $ 1,917,356 Year ending December 31, 2019 1,456,164 Year ending December 31, 2020 685,349 Year ending December 31, 2021 206,595 Year ending December 31, 2022 54,726 Year ending December 31, 2023 and thereafter — Total $ 4,320,190 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
INCOME TAXES | |
INCOME TAXES | 12. INCOME TAXES A reconciliation of income tax expense at the statutory rate to income tax expense at our effective tax rate is as follows: 2017 2016 2015 Tax Expense (Benefit) Computed at 34 % of Pretax Income (Loss) $ (8,813,237) $ (6,595,452) $ (4,903,000) Changes in Tax Laws 29,450,000 — — Foreign Income Tax Expense — (404,527) — Effect of Change in Valuation Allowance 20,636,763 (6,595,452) (4,903,000) Total Income Tax Expense $ — $ 404,527 $ — The details of the net deferred tax asset are as follows: December 31, 2017 2016 Deferred tax assets: Net Operating Loss Carryforward $ 35,030,000 $ 51,463,000 Stock Based Compensation 5,030,000 7,704,000 Deferred Revenue 3,512,000 6,478,000 General Business Credit 6,872,000 6,146,000 Accrued Expenses 341,000 605,000 Inventories 909,000 494,000 Book over Tax Depreciation 32,000 61,000 Allowance for Doubtful Accounts 2,000 2,000 Total Deferred Tax Assets 51,728,000 72,953,000 Deferred Tax Liabilities: Goodwill & Intangible Assets 98,000 137,000 Prepaid Expenses 136,000 182,000 Total Deferred Tax Liabilities 234,000 319,000 Subtotal 51,494,000 72,634,000 Valuation Allowance (51,494,000) (72,634,000) Net Deferred Tax Asset $ — $ — TCJA tax reform legislation enacted on December 22, 2017 makes major changes to the U.S. corporate income tax system, including lowering the U.S. federal corporate income tax rate to 21 percent from 35 percent, limiting or eliminating certain existing tax deductions, credits and incentives, allowing immediately expensing of capital expenditures through 2022, and eliminating the expiration of net operating loss carryforwards for losses generated in 2018 or after. ASC 740 requires companies to recognize the effects of tax law changes in the period of enactment, which for us was the fourth quarter of 2017, even though the effective date of most provisions of the TCJA is January 1, 2018. TCJA resulted in significant changes to the our fourth quarter 2017 income tax provision most notably a reduction in our deferred tax asset, before valuation allowance, as a result of the lower corporate income tax rate. Deferred tax assets result primarily from net operating loss carryforwards. For tax purposes, we have net operating loss carryforwards of approximately $166,800,000 that expire between 2018 and 2037. In assessing the potential for realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized upon the generation of future taxable income during the periods in which those temporary differences become deductible. We recognized no income tax expense or benefit for the years ended December 31, 2017 and 2015. We recognized $404,527 in foreign income taxes paid for the year ended December 31, 2016. While we anticipate generating income within the next year or two, we expect to incur operating losses until our drug products are marketed and generating sufficient profits to offset our operating expenses. Considered together with our limited history of operating income and our net losses in 2017, 2016 and 2015, management has placed a full valuation allowance against the net deferred tax assets as of December 31, 2017 and 2016. The portion of the valuation allowance resulting from excess tax benefits on share based compensation that would be credited directly to contributed capital if recognized in subsequent periods is $3.0 million. We account for our uncertain tax positions in accordance with ASC 740‑10, Income Taxes and the amount of unrecognized tax benefits related to tax positions is not significant at December 31, 2017 and 2016. |
Capital Stock
Capital Stock | 12 Months Ended |
Dec. 31, 2017 | |
CAPITAL STOCK | |
CAPITAL STOCK | 13. CAPITAL STOCK Our authorized capital stock consists of 2,000,000 preferred shares, none of which were issued or outstanding at December 31, 2017, 2016 and 2015, and 120,000,000 common shares, no par value per share, of which the following shares were outstanding: 2017 2016 2015 Shares outstanding as of December 31, 51,768,424 51,527,711 51,501,877 Summary of Share Issuances: Share Issuances related to Equity Compensation: Shares issued upon exercise of stock options by employees 28,384 25,834 657,998 Proceeds realized from stock option exercises $ 123,603 $ 80,161 $ 2,780,188 Average exercise price of options exercised $ 4.35 $ 3.10 $ 4.23 Restricted Stock Grants 530,000 — 850,000 Common Shares Holders of the common shares are entitled to one vote per share on all matters submitted to a vote of our shareholders and are entitled to receive dividends when and if declared by the Board of Directors. The Board is authorized to issue additional common shares within the limits of the our Articles of Incorporation without further shareholder action, subject to applicable stock exchange rules. |
Long Term Incentive Plan & Stoc
Long Term Incentive Plan & Stock Options | 12 Months Ended |
Dec. 31, 2017 | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | 14. LONG TERM INCENTIVE PLAN & STOCK OPTIONS Long Term Incentive Plan & Stock Options The Board of Directors adopted the Rockwell Medical, Inc., 2007 Long Term Incentive Plan (“2007 LTIP”) on April 11, 2007 as a replacement for the 1997 Stock Option Plan (the “Old Plan”) which was terminated as to future grants. No options were granted under the Old Plan after 2006 and no options remained outstanding as of December 31, 2016. The 2007 LTIP expired on April 11, 2017 and no equity awards were granted under the 2007 LTIP following its expiration. There were 11,500,000 common shares reserved for issuance under the 2007 LTIP. The Compensation Committee of the Board of Directors (the “Committee”) is responsible for the administration of the 2007 LTIP including the grant of stock based awards and other financial incentives including performance based incentives to employees, non‑employee directors and consultants. The Committee determines the terms and conditions of options and other equity based incentives including, but not limited to, the number of shares, the exercise price, term of option and vesting requirements. The Committee approved stock option grants during 2017, 2016 and 2015 and restricted stock grants in 2017 and 2015. The stock option awards were granted with an exercise price equal to the market price of the Company’s stock on the date of the grant. The options expire 10 years from the date of grant or upon termination of employment and generally vest in three equal annual installments beginning on the first anniversary of the date of grant. Restricted Stock Grants We granted 530,000 and 850,000 restricted shares in 2017 and 2015, respectively under the 2007 LTIP. There were no grants of restricted stock during 2016. These restricted stock grants were valued at the market price on the date of grant. During 2017, 480,000 performance based restricted shares were granted. Vesting is conditioned upon achievement of certain performance measures which were originally estimated to be approximately seventeen months following the grant date and may also vest based on a market performance measure. Evaluation of the expected vesting period is reviewed quarterly. During 2017, 50,000 restricted shares were granted in consideration for consulting services. During 2015, restricted stock grants aggregating 850,000 common shares were granted in October 2015 with a vesting date of approximately twenty months following the grant date. Vesting is conditioned upon continued employment with the Company. 2017 2016 2015 Restricted Shares Granted 530,000 - 850,000 Average Market Value Per Share on Grant Date $ 5.72 $ - $ 8.23 Expense related to All Restricted Shares $ 3,316,093 $ 4,361,760 $ 3,694,496 Unearned Stock Based Compensation for All Restricted Stock Awards Attributable to Future Periods. $ 1,266,666 Stock Option Grants Our standard stock option agreement under the 2007 LTIP allows for the payment of the exercise price of vested stock options either through cash remittance in exchange for newly issued shares, or through non‑cash exchange of previously issued shares held by the recipient for at least six months in exchange for our newly issued shares. The 2007 LTIP also allows for the retention of shares in payment of the exercise price and income tax withholding. The latter method results in no cash being received by us, but also results in a lower number of total shares being outstanding subsequently as a direct result of this exchange of shares. Shares returned to us in this manner would be retired. In 2017, 2016 and 2015, we received cash proceeds of $123,603, $80,161 and $2,780,188 respectively, in exchange for shares issued upon the exercise of options during the year. No income tax benefits were recognized during 2017, 2016 and 2015 related to stock option activity as we have a full valuation allowance recorded against its deferred tax assets. However, tax benefits (expense) for the excess of the value of the shares issued over the price paid of $1,209,000, $20,000 and ($943,000) were created in 2017, 2016, and 2015. The cumulative excess tax benefit at December 31, 2017 is $3.0 million, which when realized, will be credited directly to shareholders' equity. A summary of the status of the 2007 LTIP and the Old Plan is as follows: WEIGHTED AVERAGE AGGREGATE EXERCISE INTRINSIC SHARES PRICE VALUE Outstanding at December 31, 2014 6,885,083 7.41 $ 19,730,211 Granted 1,697,500 8.30 Exercised (794,248) 3.50 $ 2,780,188 Forfeited (29,333) 6.91 Outstanding at December 31, 2015 7,759,002 7.84 $ 18,648,477 Granted 30,000 6.54 Exercised (25,834) 4.35 $ 112,280 Forfeited (71,667) 9.33 Outstanding at December 31, 2016 7,691,501 7.83 $ 1,821,384 Granted 15,000 6.09 Exercised (433,500) 6.45 $ 109,847 Forfeited (367,000) 7.85 Outstanding at December 31, 2017 6,906,001 7.92 $ 976,335 OPTIONS OUTSTANDING OPTIONS EXERCISABLE WEIGHTED REMAINING WEIGHTED AVERAGE NUMBER OF CONTRACTUAL EXERCISE NUMBER OF EXERCISE RANGE OF EXERCISE PRICES OPTIONS LIFE PRICE OPTIONS PRICE $3.09 to $4.93 1.0-5.5 yrs. $ 3.31 389,500 $ 3.31 $5.86 to $7.13 .4-8.7 yrs. $ 6.43 1,887,500 $ 6.43 $8.23 to 11.49 1.8-7.8 yrs. $ 8.93 4,056,168 $ 9.02 Total 6,906,001 5.1 yrs. $ 7.92 6,333,168 $ 7.90 Intrinsic Value $ 976,335 $ 976,335 WEIGHTED AVERAGE NUMBER OF FAIR MARKET UNVESTED VALUE AT OPTIONS GRANT DATE As of December 31, 2014 2,580,500 Granted 1,697,500 $ 4.56 Forfeited (28,333) Vested (1,135,056) As of December 31, 2015 3,114,611 Granted 30,000 $ 3.85 Forfeited (71,667) Vested (1,370,778) As of December 31, 2016 1,702,166 Granted 15,000 $ 3.70 Forfeited (367,000) Vested (777,333) As of December 31, 2017 572,833 We value stock options awarded using the Black‑Scholes method. Assumptions used in the stock option valuations were: 2017 2016 2015 Volatility of share price 66% 64 - 65 % 58 - 61 % Risk free interest rate 2.00% 1.3-1.6 % 1.5 - 1.7 % Expected option life 6 yrs. 6 yrs. 6 yrs. Dividend Yield 0.0% 0.0% 0.0% We believe this valuation methodology is appropriate for estimating the fair value of stock options we grant to employees and directors which are subject to ASC 718‑10 requirements. We primarily base our determination of expected volatility through our assessment of the historical volatility of our common shares. We do not believe that we are able to rely on our historical stock option exercise and post‑vested termination activity to provide accurate data for estimating our expected term for use in determining the fair value of these options. Therefore, as allowed by Staff Accounting Bulletin (SAB) No. 107, Share‑Based Payment, we have opted to use the simplified method for estimating the expected option term equal to the midpoint between the vesting period and the contractual term. The contractual term of the option is 10 years from the date of grant and the vesting term of the option is three years from date of grant. Risk free interest rates utilized are based upon published U.S. Treasury yield curves at the date of the grant for the expected option term. For the years ended December 31, 2017, 2016 and 2015, we recognized compensation expense of $3,858,503 $5,984,524, and $5,193,481 respectively related to options granted to employees under the 2007 LTIP with a corresponding credit to common stock. At December 31, 2017, the amount of unrecorded stock-based compensation expense for stock options attributable to future periods was approximately $1,944,342 which is expected to be amortized to expense over the remaining vesting periods of the options of 8 to 25 months. |
Risk Management
Risk Management | 12 Months Ended |
Dec. 31, 2017 | |
RISK MANAGEMENT | |
RISK MANAGEMENT | 15. RISK MANAGEMENT Insurance We evaluate various kinds of risk that we are exposed to in our business. In our evaluation of risk, we evaluate options and alternatives to mitigating such risks. For certain insurable risks we may acquire insurance policies to protect against potential losses or to partially insure against certain risks. For our subsidiary, Rockwell Transportation, Inc., we maintain a partially uninsured workers' compensation plan. Under the policy, our self‑insurance retention is $350,000 per occurrence and $707,898 in aggregate coverage for the policy year ending July 1, 2018. The total amount at December 31, 2017 by which retention limits exceed the claims paid and accrued is approximately $569,000 for the policy year ending July 1, 2018. Estimated additional future claims subject to our payment of approximately $116,000 have been accrued for the year ended December 31, 2017. At December 31, 2017, approximately $300,000 was held in cash collateral and escrow by the insurance carrier for workers’ compensation insurance. At December 31, 2017 amounts held in cash collateral and escrow are included in prepaid expenses and other non-current assets in the consolidated financial statements. |
Quarterly Results of Operations
Quarterly Results of Operations | 12 Months Ended |
Dec. 31, 2017 | |
QUARTERLY RESULTS OF OPERATIONS | |
QUARTERLY RESULTS OF OPERATIONS | 16. QUARTERLY RESULTS OF OPERATION The following is a summary of the quarterly results of operations for the years ended December 31, 2017 and 2016. First Quarter Second Quarter Third Quarter Fourth Quarter 2017 Sales $ 14,592,254 $ 13,243,107 $ 14,626,904 $ 14,838,016 Cost of Sales 12,234,782 11,744,819 13,555,853 16,062,936 Gross Profit 2,357,472 1,498,288 1,071,051 (1,224,920) Selling, General and Administrative 6,100,715 6,541,179 4,791,636 5,869,879 Research and Product Development 1,214,851 1,675,494 1,304,658 2,126,397 Operating Income (Loss) (4,958,094) (6,718,385) (5,025,243) (9,221,196) Interest and Investment Income, net 216,071 (364,599) (31,751) 181,171 Foreign Currency Gain (Loss) — — — 742 Income (Loss) Before Income Taxes (4,742,023) (7,082,984) (5,056,994) (9,039,283) Income Tax Expense — — — — Net Income (Loss) $ (4,742,023) $ (7,082,984) $ (5,056,994) $ (9,039,283) Basic And Diluted Earnings (Loss) Per Share $ (0.09) $ (0.14) $ (0.10) $ (0.18) First Quarter Second Quarter Third Quarter Fourth Quarter 2016 Sales $ 13,627,048 $ 13,452,517 $ 12,814,815 $ 13,389,786 Cost of Sales 11,932,122 11,962,989 11,234,934 11,401,603 Gross Profit 1,694,926 1,489,528 1,579,881 1,988,183 Selling, General and Administrative 4,986,741 5,014,370 5,070,127 6,049,663 Research and Product Development 1,314,430 2,063,324 1,261,863 1,200,729 Operating Income (Loss) (4,606,245) (5,588,166) (4,752,109) (5,262,209) Interest and Investment Income, net 186,562 227,020 188,847 207,911 Interest Expense — — — — Income (Loss) Before Income Taxes (4,419,683) (5,361,146) (4,563,262) (5,054,298) Income Tax Expense (404,527) — — — Net Income (Loss) $ (4,824,210) $ (5,361,146) $ (4,563,262) $ (5,054,298) Basic And Diluted Earnings (Loss) Per Share $ (0.10) $ (0.11) $ (0.09) $ (0.10) |
Schedule II - Valuation And Qua
Schedule II - Valuation And Qualifying Accounts | 12 Months Ended |
Dec. 31, 2017 | |
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS | |
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS | SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS Balance at Balance Beginning at End of Period Additions (Deductions) of Period Allowance for Doubtful Accounts: Year ended December 31, 2017 $ 5,231 $ 11,711 $ (5,864) $ 11,078 Year ended December 31, 2016 $ 75,160 $ 13,348 $ (83,277) $ 5,231 Year ended December 31, 2015 $ 52,213 $ 72,877 $ (49,930) $ 75,160 Inventory Reserve: Year ended December 31, 2017 $ $ 5,330,198 $ $ 3,469,447 Year ended December 31, 2016 $ 10,662 $ 564,451 $ (11,298) $ 563,815 Year ended December 31, 2015 $ 27,274 $ 59,581 $ (76,193) $ 10,662 Deferred Tax Asset Valuation Allowance: Year ended December 31, 2017 $ $ — $ (21,140,000) $ 51,494,000 Year ended December 31, 2016 $ $ $ — $ Year ended December 31, 2015 $ $ — $ $ Allowances and reserves are deducted from the accounts to which they apply |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
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 subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. Rockwell Medical India Private Limited was formed in 2016 for the purpose of conducting certain commercial activities in India. All intercompany balances and transactions have been eliminated in consolidation. |
Shipping and Handling Revenue and Costs | Shipping and Handling Revenue and Costs Our products are generally priced on a delivered basis with the price of delivery included in the overall price of our products which is reported as sales. Separately identified freight and handling charges are also included in sales. We include shipping and handling costs, including expenses of Rockwell Transportation, Inc., in cost of sales. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider cash on hand, money market funds and unrestricted certificates of deposit 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 principally 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). 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. Management evaluates securities for other-than-temporary impairment (“OTTI”) on a quarterly basis, and more frequently when conditions warrant such an evaluation. When evaluating investment securities, consideration is given to the length of time and the extent to which the fair value has been less than cost, the financial condition and near-term prospects of the issuer, and whether the Company has the intent to sell the security or more likely than not will be required to sell the security before its anticipated recovery. The assessment of whether an OTTI exists involves a high degree of subjectivity and judgment and is based on the information available to management at a point in time. |
Accounts Receivable | Accounts Receivable Accounts receivable are stated at invoice amounts. The carrying amount of trade accounts receivable is reduced by an allowance for doubtful accounts that reflects our best estimate of accounts that may not be collected. We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience. All accounts or portions thereof deemed to be uncollectible are written off to the allowance for doubtful accounts. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined on the first‑in first‑out (FIFO) method. Inventory that is not expected to be converted to cash over the next year is classified as non-current. Our policy is to reserve for our drug product inventory that we determine is unlikely to be sold to, or if sold, unlikely to be utilized by our customers on or before its expiration date. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Expenditures for normal maintenance and repairs are charged to expense as incurred. Property and equipment are depreciated using the straight‑line method over their useful lives, which range from three to ten years. Leasehold improvements are amortized using the straight‑line method over the shorter of their useful lives or the related lease term. |
Licensing Fees | Licensing Fees License fees related to the technology, intellectual property and marketing rights for Triferic covered under certain issued patents have been capitalized and are being amortized over the life of the related patents which is generally 17 years. |
Goodwill, Intangible Assets and Long Lived Assets | Goodwill, Intangible Assets and Long Lived Assets The recorded amounts of goodwill and other intangibles from prior business combinations are based on management’s best estimates of the fair values of assets acquired and liabilities assumed at the date of acquisition. Goodwill is not amortized; however, it must be tested for impairment at least annually. Amortization continues to be recorded for other intangible assets with definite lives over their estimated useful lives. Intangible assets subject to amortization are reviewed for potential impairment whenever events or circumstances indicate that carrying amounts may not be recoverable. An impairment review of goodwill, intangible assets, and property and equipment is performed annually or whenever a change in condition occurs which indicates that the carrying amounts of assets may not be recoverable. Such changes may include changes in our business strategies and plans, changes to our customer contracts, changes to our product lines and changes in our operating practices. We use a variety of factors to assess the realizable value of long‑lived assets depending on their nature and use. The useful lives of other intangible assets are based on management’s best estimates of the period over which the assets are expected to contribute directly or indirectly to our future cash flows. Management annually evaluates the remaining useful lives of intangible assets with finite useful lives to determine whether events and circumstances warrant a revision to the remaining amortization periods. It is reasonably possible that management’s estimates of the carrying amount of goodwill and the remaining useful lives of other intangible assets may change in the near term |
Income Taxes | Income Taxes We account for income taxes in accordance with the provisions of ASC 740‑10, Income Taxes. A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between book and tax accounting and operating loss and tax credit carryforwards. A valuation allowance is established for deferred tax assets if we determine it to be more likely than not that the deferred tax asset will not be realized. The effects of tax positions are generally recognized in the financial statements consistent with amounts reflected in returns filed, or expected to be filed, with taxing authorities. For tax positions that the Company considers to be uncertain, current and deferred tax liabilities are recognized, or assets derecognized, when it is probable that an income tax liability has been incurred and the amount of the liability is reasonably estimable, or when it is probable that a tax benefit, such as a tax credit or loss carryforward, will be disallowed by a taxing authority. The amount of unrecognized tax benefits related to current tax positions is insignificant. The Company recognizes interest and penalties accrued related to unrecognized tax benefits as income tax expense. |
Research and Product Development | Research and Product Development We recognize research and product development costs as expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including Triferic and for other indications of Triferic, aggregating approximately $6,321,000, $5,840,000 and $4,961,000 in 2017, 2016 and 2015, respectively. |
Share Based Compensation | Share Based Compensation We measure the cost of employee services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards in accordance with ASC 718‑10, Compensation — Stock Compensation. The cost of equity based compensation is recognized as compensation expense over the vesting period of the awards. We estimate the fair value of compensation involving stock options utilizing the Black‑Scholes option pricing model. This model requires the input of several factors such as the expected option term, expected volatility of our stock price over the expected option term, and an expected forfeiture rate, and is subject to various assumptions. We believe the valuation methodology is appropriate for estimating the fair value of stock options we grant to employees and directors which are subject to ASC 718‑10 requirements. These amounts are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. |
Employee Retirement Plans | Employee Retirement Plans We are the sponsor of a non‑contributory 401(k) Employee Savings Plan. |
Net Earnings Per Share | Earnings per Share We compute 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. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: 2017 2016 2015 Basic Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 Effect of Dilutive Securities — — — Diluted Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 For 2017, 2016 and 2015, the dilutive effect of stock options, unvested restricted share grants and common share purchase warrants have not been included in the average shares outstanding for the calculation of diluted loss per share as the effect would be anti-dilutive as a result of our net loss in these periods. The table below summarizes potentially dilutive securities. 2017 2016 2015 Stock Options 6,906,001 7,691,501 7,759,002 Range of Exercise Prices of Stock Options $3.09 - $11.49 $3.09 - $11.49 $3.09 - $11.49 Unvested Restricted Common Shares 480,000 850,000 850,000 |
Other Comprehensive Income (Loss) | Other Comprehensive Income (Loss) Accounting principles generally require that recognized revenue, expenses, gains, and losses be included in net income. Certain changes in assets and liabilities, however, such as unrealized gains and losses on available for sale securities, are reported as a direct adjustment to the equity section of the balance sheet. Such items, along with net income (loss), are considered components of comprehensive income (loss). Accumulated Other Comprehensive Income (Loss) consists almost entirely of unrealized gains and losses on available‑for‑sale investment securities. We also record foreign currency translation adjustments to Other Comprehensive Income (Loss). However, such amounts were insignificant in 2017. |
Estimates in Preparation of Financial Statements | Estimates in Preparation of Financial Statements The preparation of financial statements in conformity with generally accepted accounting principles requires management to make certain 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 reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Summary of Significant Accounting Policies | |
Schedule of weighted average shares outstanding used in calculating basic and diluted earnings per share | 2017 2016 2015 Basic Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 Effect of Dilutive Securities — — — Diluted Weighted Average Shares Outstanding 51,067,412 50,676,180 50,068,129 |
Fair Market Value Measurement (
Fair Market Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
FAIR MARKET VALUE MEASUREMENTS | |
Schedule of carrying value and fair value of financial instruments other than trade receivables and payables | Based on the foregoing methods and assumptions, the carrying value and fair value of the Company’s financial instruments other than trade receivables and payables are as follows (in thousands): Carrying value Fair value Level 1 Level 2 Level 3 As of December 31, 2017 Financial assets Cash and cash equivalents $ 8,407 $ 8,407 $ 8,407 $ — $ — Investment securities available for sale 24,648 24,648 24,648 — — As of December 31, 2016 Financial assets Cash and cash equivalents $ 17,181 $ 17,181 $ 17,181 $ — $ — Investment securities available for sale 40,760 40,760 40,760 — — |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory | |
Schedule components of inventory | December 31, December 31, 2017 2016 Raw Materials $ 10,604,232 $ 10,903,084 Work in Process 212,505 86,452 Finished Goods 2,807,399 2,978,090 Total $ 13,624,136 $ 13,967,626 |
Property And Equipment (Tables)
Property And Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
PROPERTY AND EQUIPMENT | |
Schedule of major classes of property and equipment, stated at cost | 2017 2016 Leasehold Improvements $ 824,087 $ 728,151 Machinery and Equipment 7,893,566 7,169,223 Information Technology & Office Equipment 2,327,524 2,293,587 Laboratory Equipment 631,666 610,767 Transportation Equipment 242,277 265,198 11,919,120 11,066,926 Accumulated Depreciation (9,370,142) (9,675,351) Net Property and Equipment $ 2,548,978 $ 1,391,575 |
Summary of depreciation expense | 2017 2016 2015 Depreciation expense $ 514,009 $ 601,093 $ 655,265 |
Goodwill And Intangible Assets
Goodwill And Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
GOODWILL AND INTANGIBLE ASSETS | |
Schedule of costs are being amortized | 2017 2016 2015 Capitalized Licensing Fees $ 1,070,126 $ 1,070,126 $ 1,070,126 Accumulated Amortization (1,066,098) (1,065,744) (904,469) Capitalized Licensing Fees, Net of Amortization $ 4,028 $ 4,382 $ 165,657 Amortization Expense $ 353 $ 161,275 $ 167,029 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
ACCRUED LIABILITIES | |
Schedule of accrued liabilities | 2017 2016 Accrued Research & Development Expense $ 400,024 $ 193,638 Accrued Compensation and Benefits 1,991,874 2,002,767 Other Accrued Liabilities 2,323,814 2,013,746 Total Accrued Liabilities $ 4,715,712 $ 4,210,151 |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
OPERATING LEASES | |
Rent Expense Recognized Under Operating Leases | 2017 2016 2015 Rent Expense Recognized Under Operating Leases $ 2,463,145 $ 2,369,101 $ 2,301,930 |
Schedule of future minimum rental payments under operating lease agreements | Year ending December 31, 2018 $ 1,917,356 Year ending December 31, 2019 1,456,164 Year ending December 31, 2020 685,349 Year ending December 31, 2021 206,595 Year ending December 31, 2022 54,726 Year ending December 31, 2023 and thereafter — Total $ 4,320,190 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
INCOME TAXES | |
Schedule of reconciliation of income tax expense at the statutory rate to income tax expense at Entity's effective tax rate | 2017 2016 2015 Tax Expense (Benefit) Computed at 34 % of Pretax Income (Loss) $ (8,813,237) $ (6,595,452) $ (4,903,000) Changes in Tax Laws 29,450,000 — — Foreign Income Tax Expense — (404,527) — Effect of Change in Valuation Allowance 20,636,763 (6,595,452) (4,903,000) Total Income Tax Expense $ — $ 404,527 $ — |
Schedule of details of the net deferred tax asset | December 31, 2017 2016 Deferred tax assets: Net Operating Loss Carryforward $ 35,030,000 $ 51,463,000 Stock Based Compensation 5,030,000 7,704,000 Deferred Revenue 3,512,000 6,478,000 General Business Credit 6,872,000 6,146,000 Accrued Expenses 341,000 605,000 Inventories 909,000 494,000 Book over Tax Depreciation 32,000 61,000 Allowance for Doubtful Accounts 2,000 2,000 Total Deferred Tax Assets 51,728,000 72,953,000 Deferred Tax Liabilities: Goodwill & Intangible Assets 98,000 137,000 Prepaid Expenses 136,000 182,000 Total Deferred Tax Liabilities 234,000 319,000 Subtotal 51,494,000 72,634,000 Valuation Allowance (51,494,000) (72,634,000) Net Deferred Tax Asset $ — $ — |
Long Term Incentive Plan & St34
Long Term Incentive Plan & Stock Options (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | |
Schedule of restricted shares | 2017 2016 2015 Restricted Shares Granted 530,000 - 850,000 Average Market Value Per Share on Grant Date $ 5.72 $ - $ 8.23 Expense related to All Restricted Shares $ 3,316,093 $ 4,361,760 $ 3,694,496 Unearned Stock Based Compensation for All Restricted Stock Awards Attributable to Future Periods. $ 1,266,666 |
Summary of the status of the LTIP and the Old Plan | WEIGHTED AVERAGE AGGREGATE EXERCISE INTRINSIC SHARES PRICE VALUE Outstanding at December 31, 2014 6,885,083 7.41 $ 19,730,211 Granted 1,697,500 8.30 Exercised (794,248) 3.50 $ 2,780,188 Forfeited (29,333) 6.91 Outstanding at December 31, 2015 7,759,002 7.84 $ 18,648,477 Granted 30,000 6.54 Exercised (25,834) 4.35 $ 112,280 Forfeited (71,667) 9.33 Outstanding at December 31, 2016 7,691,501 7.83 $ 1,821,384 Granted 15,000 6.09 Exercised (433,500) 6.45 $ 109,847 Forfeited (367,000) 7.85 Outstanding at December 31, 2017 6,906,001 7.92 $ 976,335 |
Schedule of options outstanding and options exercisable by range of exercise prices | OPTIONS OUTSTANDING OPTIONS EXERCISABLE WEIGHTED REMAINING WEIGHTED AVERAGE NUMBER OF CONTRACTUAL EXERCISE NUMBER OF EXERCISE RANGE OF EXERCISE PRICES OPTIONS LIFE PRICE OPTIONS PRICE $3.09 to $4.93 1.0-5.5 yrs. $ 3.31 389,500 $ 3.31 $5.86 to $7.13 .4-8.7 yrs. $ 6.43 1,887,500 $ 6.43 $8.23 to 11.49 1.8-7.8 yrs. $ 8.93 4,056,168 $ 9.02 Total 6,906,001 5.1 yrs. $ 7.92 6,333,168 $ 7.90 Intrinsic Value $ 976,335 $ 976,335 |
Schedule of unvested options | WEIGHTED AVERAGE NUMBER OF FAIR MARKET UNVESTED VALUE AT OPTIONS GRANT DATE As of December 31, 2014 2,580,500 Granted 1,697,500 $ 4.56 Forfeited (28,333) Vested (1,135,056) As of December 31, 2015 3,114,611 Granted 30,000 $ 3.85 Forfeited (71,667) Vested (1,370,778) As of December 31, 2016 1,702,166 Granted 15,000 $ 3.70 Forfeited (367,000) Vested (777,333) As of December 31, 2017 572,833 |
Schedule of assumptions used in stock option valuation | 2017 2016 2015 Volatility of share price 66% 64 - 65 % 58 - 61 % Risk free interest rate 2.00% 1.3-1.6 % 1.5 - 1.7 % Expected option life 6 yrs. 6 yrs. 6 yrs. Dividend Yield 0.0% 0.0% 0.0% |
Quarterly Results Of Operatio35
Quarterly Results Of Operations (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
QUARTERLY RESULTS OF OPERATIONS | |
Summary of the quarterly results of operations | The following is a summary of the quarterly results of operations for the years ended December 31, 2017 and 2016. First Quarter Second Quarter Third Quarter Fourth Quarter 2017 Sales $ 14,592,254 $ 13,243,107 $ 14,626,904 $ 14,838,016 Cost of Sales 12,234,782 11,744,819 13,555,853 16,062,936 Gross Profit 2,357,472 1,498,288 1,071,051 (1,224,920) Selling, General and Administrative 6,100,715 6,541,179 4,791,636 5,869,879 Research and Product Development 1,214,851 1,675,494 1,304,658 2,126,397 Operating Income (Loss) (4,958,094) (6,718,385) (5,025,243) (9,221,196) Interest and Investment Income, net 216,071 (364,599) (31,751) 181,171 Foreign Currency Gain (Loss) — — — 742 Income (Loss) Before Income Taxes (4,742,023) (7,082,984) (5,056,994) (9,039,283) Income Tax Expense — — — — Net Income (Loss) $ (4,742,023) $ (7,082,984) $ (5,056,994) $ (9,039,283) Basic And Diluted Earnings (Loss) Per Share $ (0.09) $ (0.14) $ (0.10) $ (0.18) First Quarter Second Quarter Third Quarter Fourth Quarter 2016 Sales $ 13,627,048 $ 13,452,517 $ 12,814,815 $ 13,389,786 Cost of Sales 11,932,122 11,962,989 11,234,934 11,401,603 Gross Profit 1,694,926 1,489,528 1,579,881 1,988,183 Selling, General and Administrative 4,986,741 5,014,370 5,070,127 6,049,663 Research and Product Development 1,314,430 2,063,324 1,261,863 1,200,729 Operating Income (Loss) (4,606,245) (5,588,166) (4,752,109) (5,262,209) Interest and Investment Income, net 186,562 227,020 188,847 207,911 Interest Expense — — — — Income (Loss) Before Income Taxes (4,419,683) (5,361,146) (4,563,262) (5,054,298) Income Tax Expense (404,527) — — — Net Income (Loss) $ (4,824,210) $ (5,361,146) $ (4,563,262) $ (5,054,298) Basic And Diluted Earnings (Loss) Per Share $ (0.10) $ (0.11) $ (0.09) $ (0.10) |
Summary of Significant Accoun36
Summary of Significant Accounting Policies - Revenue Recognition, PPE, Licensing and Research (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Feb. 29, 2016 | Oct. 31, 2014 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Research and Product Development | |||||||||||||
Product development and research costs | $ 2,126,397 | $ 1,304,658 | $ 1,675,494 | $ 1,214,851 | $ 1,200,729 | $ 1,261,863 | $ 2,063,324 | $ 1,314,430 | $ 6,321,400 | $ 5,840,346 | $ 4,961,313 | ||
Investments Available for Sale | |||||||||||||
Fair value of investments | 24,648,459 | 40,759,703 | 24,648,459 | 40,759,703 | |||||||||
Realized gains | $ 12,927 | 156,461 | |||||||||||
Licensing Fees | |||||||||||||
Useful life | 17 years | ||||||||||||
Research and Development | |||||||||||||
Research and Development Expense | $ 2,126,397 | $ 1,304,658 | $ 1,675,494 | $ 1,214,851 | $ 1,200,729 | $ 1,261,863 | $ 2,063,324 | $ 1,314,430 | $ 6,321,400 | 5,840,346 | 4,961,313 | ||
Minimum | |||||||||||||
PROPERTY AND EQUIPMENT | |||||||||||||
Useful life | 3 years | ||||||||||||
Maximum | |||||||||||||
PROPERTY AND EQUIPMENT | |||||||||||||
Useful life | 10 years | ||||||||||||
Wanbang Biopharmaceutical | |||||||||||||
Revenue Recognition | |||||||||||||
Upfront payment | $ 4,000,000 | ||||||||||||
Deferred drug license revenue | $ 200,000 | ||||||||||||
Baxter Healthcare Organization | |||||||||||||
Revenue Recognition | |||||||||||||
Deferred drug license revenue | $ 2,099,028 | $ 2,065,785 | $ 2,081,668 | ||||||||||
Initial Payment Received | $ 20,000,000 |
Summary of Significant Accoun37
Summary of Significant Accounting Policies - Stock Options, Warrants, and Restricted Common Stock (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Weighted average shares outstanding used in calculating basic and diluted earnings per share | |||
Basic Weighted Average Shares Outstanding | 51,067,412 | 50,676,180 | 50,068,129 |
Diluted Weighted Average Shares Outstanding | 51,067,412 | 50,676,180 | 50,068,129 |
Minimum | |||
Weighted average shares outstanding used in calculating basic and diluted earnings per share | |||
Exercise price (in dollars per share) | $ 3.09 | $ 3.09 | $ 3.09 |
Maximum | |||
Weighted average shares outstanding used in calculating basic and diluted earnings per share | |||
Exercise price (in dollars per share) | $ 11.49 | $ 11.49 | $ 11.49 |
Stock options | |||
Weighted average shares outstanding used in calculating basic and diluted earnings per share | |||
Securities excluded from diluted loss per share calculation | 6,906,001 | 7,691,501 | 7,759,002 |
Unvested restricted common shares | |||
Weighted average shares outstanding used in calculating basic and diluted earnings per share | |||
Securities excluded from diluted loss per share calculation | 480,000 | 850,000 | 850,000 |
Fair Market Value Measurements
Fair Market Value Measurements (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Financial assets | ||
Investment securities available for sale | $ 51,918,745 | $ 24,491,677 |
Carrying value | ||
Financial assets | ||
Cash and cash equivalents | 8,407,000 | 17,181,000 |
Investment securities available for sale | 24,648,000 | 40,760,000 |
Fair value | ||
Financial assets | ||
Cash and cash equivalents | 8,407,000 | 17,181,000 |
Investment securities available for sale | 24,648,000 | 40,760,000 |
Fair value | Level 1 | ||
Financial assets | ||
Cash and cash equivalents | 8,407,000 | 17,181,000 |
Investment securities available for sale | $ 24,648,000 | $ 40,760,000 |
Investments In Available For 39
Investments In Available For Sale Securities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
INVESTMENTS IN AVAILABLE FOR SALE SECURITIES | |||
Investments available for sale | $ 24,648,459 | $ 40,759,703 | |
Purchase of Securities Available for Sale | 35,733,677 | 25,781,853 | $ 21,800,000 |
Unrealized losses | 901,877 | ||
Market value of securities sold | 51,918,745 | 24,491,677 | |
Average cost basis | 52,711,407 | 24,518,497 | |
Realized gains | 12,927 | 156,461 | |
Realized losses | $ 805,134 | $ 183,281 |
Significant Market Segments A40
Significant Market Segments And Customers (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Significant market segments | |||
Accounts receivable | $ 6,355,566 | $ 6,393,228 | |
Assets | $ 58,779,640 | $ 83,153,638 | |
International sales | |||
Significant market segments | |||
Direct sales percentage of sales | 12.00% | 12.00% | 13.00% |
DaVita Healthcare Partners, Inc. | |||
Significant market segments | |||
Direct sales percentage of sales | 50.00% | 52.00% | 48.00% |
Accounts receivable | $ 2,411,367 | $ 2,224,046 | |
Baxter Healthcare Organization | |||
Significant market segments | |||
Accounts receivable | $ 1,863,412 | $ 2,430,159 | |
Baxter Healthcare Organization | Customer concentration | |||
Significant market segments | |||
Direct sales percentage of sales | 27.00% | 24.00% | 28.00% |
Distribution Agreement (Details
Distribution Agreement (Details) - Baxter Healthcare Organization - USD ($) | Oct. 02, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Distribution agreement term | 10 years | |||
Upfront fee | $ 20,000,000 | |||
Recognized Distribution Agreement Income | $ 2,099,028 | $ 2,065,785 | $ 2,081,668 | |
Payment (made) received | $ 0 | |||
Agreement termination notice period | 270 days | |||
Agreement termination significant price increase notice period | 45 days | |||
Agreement termination limited non-compete period | 2 years | |||
Agreement Refund Trigger Event repayment percent first criteria | 33.00% | |||
Agreement Refund Trigger Event repayment percent second criteria | 25.00% | |||
Agreement property infringement repayment amount first criteria | $ 10,000,000 | |||
Agreement property infringement repayment amount second criteria | $ 6,600,000 | |||
Agreement extension period | 5 years | |||
Extension fee | $ 7,500,000 |
Inventory (Details)
Inventory (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory | ||
Raw Materials | $ 10,604,232 | $ 10,903,084 |
Work in Process | 212,505 | 86,452 |
Finished Goods | 2,807,399 | 2,978,090 |
Total | 13,624,136 | 13,967,626 |
Inventory, Noncurrent | $ 5,986,752 | $ 1,826,554 |
Property And Equipment (Details
Property And Equipment (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property and equipment | |||
Gross Property and Equipment | $ 11,919,120 | $ 11,066,926 | |
Accumulated Depreciation | (9,370,142) | (9,675,351) | |
Property, Plant and Equipment, Net | 2,548,978 | 1,391,575 | |
Depreciation expense | 514,009 | 601,093 | $ 655,265 |
Leasehold Improvements | |||
Property and equipment | |||
Gross Property and Equipment | 824,087 | 728,151 | |
Machinery and Equipment | |||
Property and equipment | |||
Gross Property and Equipment | 7,893,566 | 7,169,223 | |
Information Technology & Office Equipment | |||
Property and equipment | |||
Gross Property and Equipment | 2,327,524 | 2,293,587 | |
Laboratory Equipment | |||
Property and equipment | |||
Gross Property and Equipment | 631,666 | 610,767 | |
Transportation Equipment | |||
Property and equipment | |||
Gross Property and Equipment | $ 242,277 | $ 265,198 |
Goodwill And Intangible Asset44
Goodwill And Intangible Assets (Details) - USD ($) | Nov. 30, 2016 | Nov. 30, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2011 |
Intangible assets | |||||||
Goodwill | $ 920,745 | $ 920,745 | |||||
Adjustment for impairment of goodwill | $ 0 | $ 0 | |||||
Milestone achievement expense | 275,000 | ||||||
Global licensing agreement | |||||||
Intangible assets | |||||||
Capitalized Licensing Fees | 1,070,126 | 1,070,126 | $ 1,070,126 | ||||
Accumulated Amortization | (1,066,098) | (1,065,744) | (904,469) | ||||
Capitalized Licensing Fees, Net of Amortization | 4,028 | 4,382 | 165,657 | ||||
Amortization expense | $ 353 | $ 161,275 | $ 167,029 | ||||
ANDA | |||||||
Intangible assets | |||||||
Amortization period | 5 years | ||||||
Capitalized Licensing Fees, Net of Amortization | $ 695,000 | ||||||
Patent costs | Forecast | |||||||
Intangible assets | |||||||
Amortization expense | $ 353 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
ACCRUED LIABILITIES | ||
Accrued Research & Development Expense | $ 400,024 | $ 193,638 |
Accrued Compensation and Benefits | 1,991,874 | 2,002,767 |
Other Accrued Liabilities | 2,323,814 | 2,013,746 |
Total Accrued Liabilities | $ 4,715,712 | $ 4,210,151 |
Operating Leases (Details)
Operating Leases (Details) | 12 Months Ended | ||
Dec. 31, 2017USD ($)ft² | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
OPERATING LEASES | |||
Area occupied by Entity (in square feet) | ft² | 51,000 | ||
Rent Expense Recognized Under Operating Leases | $ 2,463,145 | $ 2,369,101 | $ 2,301,930 |
Future minimum rental payments under operating lease agreements | |||
Year ending December 31, 2018 | 1,917,356 | ||
Year ending December 31, 2019 | 1,456,164 | ||
Year ending December 31, 2020 | 685,349 | ||
Year ending December 31, 2021 | 206,595 | ||
Year ending December 31, 2022 | 54,726 | ||
Total | $ 4,320,190 | ||
Maximum | |||
OPERATING LEASES | |||
Lease term | 7 years | ||
Michigan | |||
OPERATING LEASES | |||
Area occupied by Entity (in square feet) | ft² | 17,500 | ||
Texas | |||
OPERATING LEASES | |||
Area occupied by Entity (in square feet) | ft² | 51,000 | ||
South Carolina | |||
OPERATING LEASES | |||
Area occupied by Entity (in square feet) | ft² | 57,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Jan. 01, 2018 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Statutory rate (as a percent) | 34.00% | |||||
Reconciliation of income tax expense at the statutory rate to income tax expense at Entity's effective tax rate | ||||||
Tax Expense (Benefit) Computed at 34 % of Pretax Income (Loss) | $ (8,813,237) | $ (6,595,452) | $ (4,903,000) | |||
Changes in Tax Laws | 29,450,000 | |||||
Foreign Income Tax Expense | (404,527) | |||||
Effect of Change in Valuation Allowance | 20,636,763 | (6,595,452) | (4,903,000) | |||
Total Income Tax Expense | $ (404,527) | 0 | (404,527) | $ 0 | $ 0 | |
Deferred tax assets: | ||||||
Net Operating Loss Carryforward | 35,030,000 | 51,463,000 | ||||
Stock Based Compensation | 5,030,000 | 7,704,000 | ||||
Deferred Revenue | 3,512,000 | 6,478,000 | ||||
General Business Credit | 6,872,000 | 6,146,000 | ||||
Accrued Expenses | 341,000 | 605,000 | ||||
Inventories | 909,000 | 494,000 | ||||
Book over Tax Depreciation | 32,000 | 61,000 | ||||
Accounts Receivable | 2,000 | 2,000 | ||||
Total Deferred Tax Assets | 51,728,000 | 72,953,000 | ||||
Deferred Tax Liabilities: | ||||||
Goodwill & Intangible Assets | 98,000 | 137,000 | ||||
Prepaid Expenses | 136,000 | 182,000 | ||||
Total Deferred Tax Liabilities | 234,000 | 319,000 | ||||
Subtotal | 51,494,000 | 72,634,000 | ||||
Valuation Allowance | (51,494,000) | (72,634,000) | ||||
Net Deferred Tax Asset | 0 | $ 0 | ||||
Net operating loss carryforwards that expire between 2018 and 20137 | 166,800,000 | |||||
Excess tax benefits on share based compensation that would be credited directly to contributed capital, if recognized | $ 3,000,000 | |||||
Forecast | ||||||
Statutory rate (as a percent) | 21.00% |
Capital Stock - Shares (Details
Capital Stock - Shares (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CAPITAL STOCK | |||
Preferred Shares, shares authorized | 2,000,000 | 2,000,000 | 2,000,000 |
Preferred Shares, shares issued | 0 | 0 | 0 |
Preferred Shares, shares outstanding | 0 | 0 | 0 |
Common Shares, shares authorized | 120,000,000 | 120,000,000 | 120,000,000 |
Common Shares, par value (in dollars per share) | $ 0 | $ 0 | $ 0 |
Common Shares, shares outstanding | 51,768,424 | 51,527,711 | 51,501,877 |
Share Issuances related to Equity Compensation: | |||
Shares issued upon exercise of stock options by employees | 28,384 | 25,834 | 657,998 |
Proceeds realized from stock option exercises (in dollars) | $ 123,603 | $ 80,161 | $ 2,780,188 |
Average exercise price of options exercised (in dollars per share) | $ 4.35 | $ 3.10 | $ 4.23 |
Restricted Stock Grants (in shares) | 530,000 | 850,000 | |
Share issuances in Exchange for Services | |||
Value of Shares issued in Exchange for Services (in dollars) | $ 228,847 |
Long Term Incentive Plan & St49
Long Term Incentive Plan & Stock Options - Summary of LTIP (Details) | 1 Months Ended | 12 Months Ended | 120 Months Ended | |||
Oct. 31, 2015shares | Dec. 31, 2017USD ($)installment$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2014USD ($) | |
Additional disclosures | ||||||
Restricted shares granted | 530,000 | 850,000 | ||||
Cash proceeds received upon the exercise of options | $ | $ 123,603 | $ 80,161 | $ 2,780,188 | |||
Income tax expense related to stock option activity | $ | 1,209,000 | $ 20,000 | $ (943,000) | |||
Excess tax benefits on share based compensation that would be credited directly to contributed capital, if recognized | $ | $ 3,000,000 | |||||
WEIGHTED AVERAGE EXERCISE PRICE | ||||||
Exercised (in dollars per share) | $ / shares | $ 4.35 | $ 3.10 | $ 4.23 | |||
AGGREGATE INTRINSIC VALUE | ||||||
Outstanding (in dollars) | $ | $ 976,335 | |||||
Stock options | ||||||
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | ||||||
Expiration term | 10 years | |||||
Number of vesting installments | installment | 3 | |||||
Vesting period | 3 years | |||||
Additional disclosures | ||||||
Minimum period for which previously issued shares are to be held by the recipient for non-cash exchange to newly issued shares | 6 months | |||||
LTIP And Old Plan | ||||||
AGGREGATE INTRINSIC VALUE | ||||||
Outstanding (in dollars) | $ | $ 976,335 | $ 1,821,384 | $ 18,648,477 | $ 1,821,384 | $ 19,730,211 | |
Exercised (in dollars) | $ | $ 109,847 | |||||
LTIP And Old Plan | Stock options | ||||||
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | ||||||
Options granted (in shares) | 15,000 | 30,000 | 1,697,500 | |||
SHARES | ||||||
Outstanding at the beginning of the period (in shares) | 7,691,501 | 7,759,002 | 6,885,083 | |||
Granted (in shares) | 15,000 | 30,000 | 1,697,500 | |||
Exercised (in shares) | (433,500) | (25,834) | (794,248) | |||
Forfeited (in shares) | (367,000) | (71,667) | (29,333) | |||
Outstanding at the end of the period (in shares) | 6,906,001 | 7,691,501 | 7,759,002 | 7,691,501 | ||
WEIGHTED AVERAGE EXERCISE PRICE | ||||||
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 7.83 | $ 7.84 | $ 7.41 | |||
Granted (in dollars per share) | $ / shares | 6.09 | 6.54 | 8.30 | |||
Exercised (in dollars per share) | $ / shares | 6.45 | 4.35 | 3.50 | |||
Forfeited (in dollars per share) | $ / shares | 7.85 | 9.33 | 6.91 | |||
Outstanding at the end of the period (in dollars per share) | $ / shares | $ 7.92 | $ 7.83 | $ 7.84 | $ 7.83 | ||
AGGREGATE INTRINSIC VALUE | ||||||
Exercised (in dollars) | $ | $ 112,280 | $ 2,780,188 | ||||
LTIP | ||||||
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | ||||||
Number of common shares reserved for issuance | 11,500,000 | |||||
Additional disclosures | ||||||
Restricted shares granted | 530,000 | 0 | 850,000 | |||
Expense related to All Restricted Shares | $ | $ 3,858,503 | $ 5,984,524 | $ 5,193,481 | |||
LTIP | Unvested restricted common shares | ||||||
Additional disclosures | ||||||
Restricted shares granted | 530,000 | 850,000 | ||||
Average Market Value Per Share on Grant Date | $ / shares | $ 5.72 | $ 8.23 | ||||
Expense related to All Restricted Shares | $ | $ 3,316,093 | $ 4,361,760 | $ 3,694,496 | |||
Unearned Stock Based Compensation for All Restricted Stock Awards Attributable to Future Periods | $ | $ 1,266,666 | |||||
LTIP | Unvested restricted common shares | 2015 grant | ||||||
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | ||||||
Vesting period | 20 months | |||||
Additional disclosures | ||||||
Restricted shares granted | 850,000 | |||||
Old Plan | ||||||
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | ||||||
Options granted (in shares) | 0 | |||||
SHARES | ||||||
Granted (in shares) | 0 | |||||
Outstanding at the end of the period (in shares) | 0 | |||||
Shares granted for consulting services | ||||||
Additional disclosures | ||||||
Restricted shares granted | 50,000 | |||||
Shares awarded for performance | ||||||
Additional disclosures | ||||||
Restricted shares granted | 480,000 |
Long Term Incentive Plan & St50
Long Term Incentive Plan & Stock Options - Options (Details) | 12 Months Ended |
Dec. 31, 2017USD ($)$ / sharesshares | |
OPTIONS OUTSTANDING | |
NUMBER OF OPTIONS (in shares) | shares | 6,906,001 |
REMAINING CONTRACTUAL LIFE | 5 years 1 month 6 days |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 7.92 |
Intrinsic Value (in dollars) | $ | $ 976,335 |
OPTIONS EXERCISABLE | |
NUMBER OF OPTIONS (in shares) | shares | 6,333,168 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 7.90 |
Intrinsic Value (in dollars) | $ | $ 976,335 |
$3.09 to $4.93 | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | |
Exercise price, low end of range (in dollars per share) | $ 3.09 |
Exercise price, high end of range (in dollars per share) | $ 4.93 |
OPTIONS OUTSTANDING | |
NUMBER OF OPTIONS (in shares) | shares | 389,500 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 3.31 |
OPTIONS EXERCISABLE | |
NUMBER OF OPTIONS (in shares) | shares | 389,500 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 3.31 |
$3.09 to $4.93 | Minimum | |
OPTIONS OUTSTANDING | |
REMAINING CONTRACTUAL LIFE | 1 year |
$5.86 to $7.13 | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | |
Exercise price, low end of range (in dollars per share) | $ 5.86 |
Exercise price, high end of range (in dollars per share) | $ 7.13 |
OPTIONS OUTSTANDING | |
NUMBER OF OPTIONS (in shares) | shares | 1,922,500 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 6.43 |
OPTIONS EXERCISABLE | |
NUMBER OF OPTIONS (in shares) | shares | 1,887,500 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 6.43 |
$5.86 to $7.13 | Minimum | |
OPTIONS OUTSTANDING | |
REMAINING CONTRACTUAL LIFE | 4 months 24 days |
$8.23 to $11.49 | |
LONG TERM INCENTIVE PLAN & STOCK OPTIONS | |
Exercise price, low end of range (in dollars per share) | $ 8.23 |
Exercise price, high end of range (in dollars per share) | $ 11.49 |
OPTIONS OUTSTANDING | |
NUMBER OF OPTIONS (in shares) | shares | 4,594,001 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 8.93 |
OPTIONS EXERCISABLE | |
NUMBER OF OPTIONS (in shares) | shares | 4,056,168 |
WEIGHTED EXERCISE PRICE (in dollars per share) | $ 9.02 |
$8.23 to $11.49 | Minimum | |
OPTIONS OUTSTANDING | |
REMAINING CONTRACTUAL LIFE | 1 year 9 months 18 days |
Long Term Incentive Plan & St51
Long Term Incentive Plan & Stock Options - Unvested Options and Value (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Assumptions used to estimate the fair market value of stock options granted | |||
Volatility of share price (as a percent) | 66.00% | ||
Risk free interest rate (as a percent) | 2.00% | ||
Expected option life | 6 years | 6 years | |
Dividend yield (as a percent) | 0.00% | 0.00% | |
Additional disclosures | |||
Unrecorded stock-based compensation expense (in dollars) | $ 1,944,342 | ||
Minimum | |||
Additional disclosures | |||
Period for amortizing unrecognized compensation cost to expense | 8 months | ||
Maximum | |||
Additional disclosures | |||
Period for amortizing unrecognized compensation cost to expense | 25 months | ||
Stock options | |||
NUMBER OF UNVESTED OPTIONS | |||
Beginning of the period (in shares) | 1,702,166 | 3,114,611 | 2,580,500 |
Granted (in shares) | 15,000 | 30,000 | 1,697,500 |
Forfeited (in shares) | (367,000) | (71,667) | (28,333) |
Vested (in shares) | (777,333) | (1,370,778) | (1,135,056) |
End of the period (in shares) | 572,833 | 1,702,166 | 3,114,611 |
WEIGHTED AVERAGE FAIR MARKET VALUE AT GRANT DATE | |||
Granted (in dollars per share) | $ 3.70 | $ 3.85 | $ 4.56 |
Assumptions used to estimate the fair market value of stock options granted | |||
Expected option life | 6 years | ||
Dividend yield (as a percent) | 0.00% | ||
Additional disclosures | |||
Expiration term | 10 years | ||
Vesting period | 3 years | ||
Stock options | Minimum | |||
Assumptions used to estimate the fair market value of stock options granted | |||
Volatility of share price (as a percent) | 64.00% | 58.00% | |
Risk free interest rate (as a percent) | 1.30% | 1.50% | |
Stock options | Maximum | |||
Assumptions used to estimate the fair market value of stock options granted | |||
Volatility of share price (as a percent) | 65.00% | 61.00% | |
Risk free interest rate (as a percent) | 1.60% | 1.70% | |
LTIP | |||
Additional disclosures | |||
Compensation expense (in dollars) | $ 3,858,503 | $ 5,984,524 | $ 5,193,481 |
Risk Management (Details)
Risk Management (Details) - USD ($) | Jul. 01, 2017 | Dec. 31, 2017 |
RISK MANAGEMENT | ||
Self insurance retention per occurrence | $ 350,000 | |
Aggregate coverage | $ 707,898 | |
Retention limit in excess of claims paid and accrued | $ 569,000 | |
Estimated additional future claims | 116,000 | |
Cash collateral and escrow held by insurance carrier for workers' compensation insurance | $ 300,000 |
Quarterly Results Of Operatio53
Quarterly Results Of Operations (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
QUARTERLY RESULTS OF OPERATIONS | ||||||||||||
Sales | $ 14,838,016 | $ 14,626,904 | $ 13,243,107 | $ 14,592,254 | $ 13,389,786 | $ 12,814,815 | $ 13,452,517 | $ 13,627,048 | $ 57,300,281 | $ 53,284,166 | $ 55,350,702 | |
Cost of Sales | 16,062,936 | 13,555,853 | 11,744,819 | 12,234,782 | 11,401,603 | 11,234,934 | 11,962,989 | 11,932,122 | 53,598,390 | 46,531,648 | 46,412,848 | |
Gross Profit | (1,224,920) | 1,071,051 | 1,498,288 | 2,357,472 | 1,988,183 | 1,579,881 | 1,489,528 | 1,694,926 | 3,701,891 | 6,752,518 | 8,937,854 | |
Selling, General and Administrative | 5,869,879 | 4,791,636 | 6,541,179 | 6,100,715 | 6,049,663 | 5,070,127 | 5,014,370 | 4,986,741 | 23,303,409 | 21,120,901 | 19,078,867 | |
Research and Product Development | 2,126,397 | 1,304,658 | 1,675,494 | 1,214,851 | 1,200,729 | 1,261,863 | 2,063,324 | 1,314,430 | 6,321,400 | 5,840,346 | 4,961,313 | |
Operating Income (Loss) | (9,221,196) | (5,025,243) | (6,718,385) | (4,958,094) | (5,262,209) | (4,752,109) | (5,588,166) | (4,606,245) | (25,922,918) | (20,208,729) | (15,102,326) | |
Interest and Investment Income, net | 181,171 | (31,751) | (364,599) | 216,071 | 207,911 | 188,847 | 227,020 | 186,562 | 892 | 810,340 | 681,876 | |
Foreign Currency Gain (Loss) | 742 | 742 | ||||||||||
Income (Loss) Before Income Taxes | (9,039,283) | (5,056,994) | (7,082,984) | (4,742,023) | (5,054,298) | (4,563,262) | (5,361,146) | (4,419,683) | (25,921,284) | (19,398,389) | (14,420,450) | |
Income Tax Expense | 404,527 | 0 | 404,527 | 0 | $ 0 | |||||||
Net Income (Loss) | $ (9,039,283) | $ (5,056,994) | $ (7,082,984) | $ (4,742,023) | $ (5,054,298) | $ (4,563,262) | $ (5,361,146) | $ (4,824,210) | $ (25,921,284) | $ (19,802,916) | $ (14,420,450) | |
Basic And Diluted Earnings (Loss) Per Share (in dollars per share) | $ (0.18) | $ (0.10) | $ (0.14) | $ (0.09) | $ (0.10) | $ (0.09) | $ (0.11) | $ (0.10) |
Schedule II - Valuation And Q54
Schedule II - Valuation And Qualifying Accounts (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Allowance for Doubtful Accounts | |||
Valuation and Qualifying Accounts | |||
Balance at Beginning of Period | $ 5,231 | $ 75,160 | $ 52,213 |
Additions | 11,711 | 13,348 | 72,877 |
(Deductions) | (5,864) | (83,277) | (49,930) |
Balance at End of Period | 11,078 | 5,231 | 75,160 |
Inventory Reserve | |||
Valuation and Qualifying Accounts | |||
Balance at Beginning of Period | 563,815 | 10,662 | 27,274 |
Additions | 5,330,198 | 564,451 | 59,581 |
(Deductions) | (2,424,566) | (11,298) | (76,193) |
Balance at End of Period | 3,469,447 | 563,815 | 10,662 |
Deferred Tax Asset Valuation Allowance | |||
Valuation and Qualifying Accounts | |||
Balance at Beginning of Period | 72,634,000 | 69,014,000 | 69,307,000 |
Additions | 3,620,000 | ||
(Deductions) | (21,140,000) | (293,000) | |
Balance at End of Period | $ 51,494,000 | $ 72,634,000 | $ 69,014,000 |