Rockwell Medical (RMTI) 10-Q/A 14 Aug 18 2018 Q1 Quarterly report (amended) Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2018	Apr. 30, 2018
Document and Entity Information
Entity Registrant Name	ROCKWELL MEDICAL, INC.
Entity Central Index Key	1,041,024
Document Type	10-Q/A
Document Period End Date	Mar. 31, 2018
Amendment Flag	true
Amendment Description	This Amendment No. 1 to Form 10-Q (this "Amendment") amends the Quarterly Report on Form 10-Q for the three months ended March 31, 2018 originally filed with the Securities and Exchange Commission ("SEC") on May 10, 2018 (the "Original Filing") by Rockwell Medical, Inc. (the "Company", "we", "us", or "our"). Restatement As further discussed in Note 3 to our unaudited consolidated financial statements in Part I, Item 1. "Financial Statements" of this Amendment, subsequent to the issuance of the Original Filing, the Company's Audit Committee of the Board of Directors (the "Board"), based upon the recommendation of management, concluded that we should restate our previously issued unaudited consolidated financial statements for the three-month quarterly period ended March 31, 2018 to correct for the understatement of our excess and obsolete Triferic inventory reserves and the overstatement of our stock-based compensation expense and bonus accruals. Disclosure Controls and Procedures As a result of the resignation of our prior independent registered public accountant, Plante & Moran PLLC ("Plante") and its identification of a material weakness in our internal control over financial reporting for the three-month quarterly period ended March 31, 2018, we subsequently reassessed our evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2018. As a result, our management concluded that we did not maintain effective disclosure controls and procedures due to the material weaknesses in internal control over financial reporting which existed as of March 31, 2018. For a description of the material weaknesses in internal control over financial reporting and actions taken, and to be taken, to address the material weakness, see Part 1, Item 4. "Controls and Procedures" of this Amendment. Amendment This Amendment (i) restates our previously issued unaudited consolidated financial statements and related disclosures in Part I, Item 1. "Financial Statements" for the three months ended March 31, 2018, as well as related disclosures in Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations," to reflect the over accrual of discretionary bonuses, overstatement of stock-based compensation expense and to reflect our reassessment of the adequacy of our excess and obsolete Triferic inventory reserves as of and for the three-month quarterly period ended March 31, 2018 and the status of obtaining separate reimbursement for Triferic and (ii) amends and restates in its entirety Part I, Item 4. "Controls and Procedures" of the Original Filing to reflect the Audit Committee's conclusion, based upon the recommendation of management, that our internal control over financial reporting and disclosure controls and procedures were not effective as of March 31, 2018, due to the identification of a material weaknesses in our internal control over financial reporting which resulted in the understatement of our Triferic inventory reserves. In addition, during the three months ended March 31, 2018, the Company reclassified $2.3 million of its inventory from a current asset to a non-current asset and reclassified $2.3 million of its deferred license revenue from long-term liabilities to current liabilities. Except as expressly set forth herein, this Amendment does not reflect events occurring after the date of the Original Filing or modify or update any of the other disclosures contained therein in any way other than as required to be reflected herein. Accordingly, this Amendment should be read in conjunction with the Original Filing and our other filings with the SEC. Items Amended in this Filing For the reasons discussed above, we are filing this Amendment in order to amend the following items in our Original Report and only to the extent necessary to reflect the adjustments discussed above and make corresponding revisions to our financial data cited elsewhere in this Amendment: Part I, Item 1. Financial Statements Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Part I, Item 4. Controls and Procedures In accordance with applicable SEC rules, this Amendment includes new certifications required by Rule 12a-14 under the Securities Exchange Act of 1934, as amended, from our Interim Principal Executive Officer and Principal Accounting Officer dated as of the date of filing of this Amendment.
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		51,768,424
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q1

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2018	Dec. 31, 2017
ASSETS
Cash and Cash Equivalents	$ 3,278,087	$ 8,406,917
Investments Available for Sale	24,821,682	24,648,459
Accounts Receivable, net of a reserve of $3,400 in 2018 and $11,000 in 2017	5,993,708	6,355,566
Inventory	5,510,154	7,637,384
Other Current Assets	1,607,440	1,779,992
Total Current Assets	41,211,071	48,828,318
Property and Equipment, net	2,572,619	2,548,978
Inventory, Non-Current	6,007,601	5,986,752
Intangible Assets	3,940	4,028
Goodwill	920,745	920,745
Other Non-current Assets	490,703	490,819
Total Assets	51,206,679	58,779,640
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts Payable	4,012,341	4,222,159
Accrued Liabilities	3,191,501	4,715,712
Customer Deposits	235,078	205,303
Current portion of Deferred License Revenue	2,285,932
Total Current Liabilities	9,724,852	9,143,174
Deferred License Revenue	13,864,677	16,723,318
Total Liabilities	23,589,529	25,866,492
Shareholders' Equity:
Common Shares, no par value, 51,768,424 and 51,768,424 shares issued and outstanding	273,656,910	273,210,907
Accumulated Deficit	(245,811,897)	(240,262,376)
Accumulated Other Comprehensive Income	(227,863)	(35,383)
Total Shareholders' Equity	27,617,150	32,913,148
Total Liabilities And Shareholders' Equity	$ 51,206,679	$ 58,779,640

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets Parenthetical) - USD ($)	Mar. 31, 2018	Dec. 31, 2017
CONDENSED CONSOLIDATED BALANCE SHEETS
Allowance for reserve, accounts receivable (in dollars)	$ 3,400	$ 11,000
Common Shares, par value (in dollars per share)	$ 0	$ 0
Common Shares, shares issued	51,768,424	51,768,424
Common Shares, shares outstanding	51,768,424	51,768,424

Condensed Consolidated Income S

Condensed Consolidated Income Statements - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
CONDENSED CONSOLIDATED INCOME STATEMENTS
Sales	$ 14,948,579	$ 14,592,254
Cost of Sales	15,669,072	12,234,782
Gross Profit	(720,493)	2,357,472
Selling, General and Administrative	3,331,955	6,100,715
Research and Product Development	1,666,356	1,214,851
Operating Loss	(5,718,804)	(4,958,094)
Interest and Investment Income	169,283	216,071
Net Loss	$ (5,549,521)	$ (4,742,023)
Basic and Diluted Net Loss per Share	$ (0.11)	$ (0.09)
Basic and Diluted Weighted Average Shares Outstanding	51,288,424	50,686,044

Condensed Consolidated Statemen

Condensed Consolidated Statements Of Comprehensive Income (Loss) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Net Income (Loss)	$ (5,549,521)	$ (4,742,023)
Unrealized Gain (Loss) on Available-for-Sale Investments	(189,995)	112,002
Foreign Currency Translation Adjustments	(2,485)	505
Comprehensive Income (Loss)	$ (5,742,001)	$ (4,629,516)

Condensed Consolidated Stateme6

Condensed Consolidated Statements Of Changes In Shareholders' Equity - 3 months ended Mar. 31, 2018 - USD ($)	COMMON SHARES	ACCUMULATED DEFICIT	ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS)	Total
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
Increase (Decrease) in Shareholders' Equity
Net Loss		(5,549,521)		$ (5,549,521)
Unrealized (Loss) on Available-for-Sale Investments			(189,995)	(189,995)
Foreign Currency Rate Changes			(2,485)	(2,485)
Stock-Based Compensation Expense	$ 446,003			446,003
Balance at Mar. 31, 2018	$ 273,656,910	$ (245,811,897)	$ (227,863)	$ 27,617,150
Balance (in shares) at Mar. 31, 2018	51,768,424			51,768,424

Condensed Consolidated Stateme7

Condensed Consolidated Statements Of Cash Flow - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Cash Flows From Operating Activities:
Net (Loss)	$ (5,549,521)	$ (4,742,023)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
Depreciation and Amortization	129,076	130,215
Share Based Compensation	446,003	2,259,316
Increase in Inventory Reserves	2,046,954
Loss on Disposal of Assets	3,083	3,350
Loss on Sale of Investments Available for Sale	2,892
Changes in Assets and Liabilities:
Decrease (Increase) in Accounts Receivable	295,973	(344,500)
Decrease (Increase) in Inventory	59,427	(2,291,108)
Decrease in Other Assets	238,438	160,406
(Decrease) in Accounts Payable	(209,208)	(1,914,780)
(Decrease) Increase in Other Liabilities	(1,494,969)	2,160,268
(Decrease) in Deferred License Revenue	(572,709)	(498,120)
Changes in Assets and Liabilities	(1,683,048)	(2,727,834)
Cash (Used In) Operating Activities	(4,604,561)	(5,076,976)
Cash Flows From Investing Activities:
Purchase of Investments Available for Sale	(1,416,665)
Sale of Investments Available for Sale	1,050,554	31,123
Purchase of Equipment	(155,712)	(162,003)
Proceeds on Sale of Assets		450
Cash (Used In) Investing Activities	(521,823)	(130,430)
Cash Flows From Financing Activities:
Effects of exchange rate changes	(2,446)	632
(Decrease) In Cash	(5,128,830)	(5,206,774)
Cash At Beginning Of Period	8,406,917	17,180,594
Cash At End Of Period	$ 3,278,087	$ 11,973,820

Description of Business

Description of Business	3 Months Ended
	Mar. 31, 2018
Description of Business
Description of Business	1. Rockwell Medical, Inc. and Subsidiaries (collectively, “we”, “our”, “us”, or the “Company”) is a fully-integrated pharmaceutical company targeting end-stage renal disease and chronic kidney disease with innovative products for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. We are currently marketing and developing unique, proprietary renal drug therapies. These renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience and outcome. We have also obtained licenses for certain dialysis related drugs which we are developing and planning to market globally. We are also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the United States and abroad. We manufacture, sell and distribute hemodialysis concentrates and other ancillary medical products and supplies used in the treatment of patients with end stage renal disease, or “ESRD”. In 2017, we supplied approximately 25% of the United States domestic market with dialysis concentrates. We also supply dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim. The majority of our sales occur in the United States. We are regulated by the United States Food and Drug Administration (“FDA”) under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies. We hold several FDA product approvals including both drugs and medical devices.

Going Concern

Going Concern	3 Months Ended
	Mar. 31, 2018
Going Concern
Going Concern	2. Going Concern As of March 31, 2018, the Company had approximate balances of $ 3.3 million of cash and cash equivalents, $24.8 million of investments available-for-sale, working capital of $31.5 million and an accumulated deficit of $245.8 million. Net cash used in operating activities for the three months ended March 31, 2018 was approximately $4.6 million. The Company will require significant additional capital to sustain its short-term operations and make the investments it needs to execute its longer-term business plan. The Company’s existing liquidity is not sufficient to fund its operations and anticipated capital expenditures within the next 12 months. The Company intends to seek additional debt or equity financing; however, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all. The Company’s recurring operating losses, net operating cash flow deficits, and an accumulated deficit, raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date of this Amended Quarterly Report. The condensed consolidated financial statements have prepared assuming the Company will continue as a going concern. The Company has not made adjustments to the accompanying condensed consolidated financial statements related to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

Restatement of the Unaudited Co

Restatement of the Unaudited Consolidated Financial Statements	3 Months Ended
	Mar. 31, 2018
Restatement of the Unaudited Consolidated Financial Statements
Restatement of the Unaudited Consolidated Financial Statements	3. Restatement of the Unaudited Condensed Consolidated Financial Statements During the preparation of the Company’s financial statements for the period ended June 30, 2018, management determined that the Company’s excess and obsolete inventory reserve as of March 31, 2018 was understated by approximately $750,000, and its stock-based compensation expense and discretionary bonus accrual was overstated by $730,000 and $1,000,000, respectively. The effect of the restatement on the Company’s unaudited condensed consolidated balance sheet as of March 31, 2018 are as follows: March 31, 2018 As Previously Reported Restatement Adjustment As Restated Inventory (1) $ 8,544,854 $ (3,034,700) $ 5,510,154 Total Current Assets (1) 44,245,771 (3,034,700) 41,211,071 Non-Current Inventory (1) 3,722,901 2,284,700 6,007,601 Total Assets 51,956,679 (750,000) 51,206,679 Accrued Liabilities 4,191,501 (1,000,000) 3,191,501 Current Portion of Deferred Revenue (1) - 2,285,932 2,285,932 Total Current Liabilities (1) 8,438,920 1,285,932 9,724,852 Deferred Revenue (1) 16,150,609 (2,285,932) 13,864,677 Total Liabilities (1) 24,589,529 (1,000,000) 23,589,529 Accumulated Deficit (246,791,897) 980,000 (245,811,897) Total Shareholders’ Equity 27,367,150 250,000 27,617,150 Total Liabilities and Shareholders’ Equity 51,956,679 (750,000) 51,206,679 (1) Includes the reclassification of $2.3 million of its inventory from a current asset to a non-current asset and $2.3 million of its deferred license revenue from long-term liabilities to current liabilities. The effect of the restatement on the Company’s unaudited condensed consolidated statement of operations for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Cost of Sales $ 14,919,072 $ 750,000 $ 15,669,072 Gross Profit 29,507 (750,000) (720,493) Selling, General and Administrative 5,061,955 (1,730,000) 3,331,955 Operating Loss (6,698,804) 980,000 (5,718,804) Net Loss (6,529,521) 980,000 (5,549,521) Basic and Diluted Loss per Share (0.13) 0.02 (0.11) Basic and Diluted Shares 51,288,424 - 51,288,424 The effect of the restatement on the Company’s unaudited condensed consolidated statement of comprehensive loss for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Comprehensive Loss $ (6,722,001) $ 980,000 $ (5,742,001) The effect of the restatement on the Company’s unaudited condensed consolidated statement of changes in shareholders’ equity for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Common Stock $ 274,386,910 $ (730,000) $ 273,656,910 Total shareholders' equity as of March 31, 2018 27,367,150 250,000 27,617,150 The effect of the restatement on the Company’s unaudited condensed consolidated statement of cash flows for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Net Loss $ (6,529,521) $ 980,000 $ (5,549,521) Stock-Based Compensation 1,176,003 (730,000) 446,003 Increase in Inventory Reserves 1,296,954 750,000 2,046,954 Decrease in Other Liabilities (494,969) (1,000,000) (1,494,969) Cash Used In Operating Activities (4,604,561) - (4,604,561) There was no impact to net cash used in investing activities or net cash used in financing activities within our condensed consolidated statement of cash flows nor was there an impact on the net decrease in cash resulting from restatement. The impacts of the restatement has been reflected throughout these unaudited financial statements, including the applicable footnotes, as appropriate.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2018
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	4. Summary of Significant Accounting Policies Basis of Presentation Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. All intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2017 has been derived from our audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of our management, all adjustments have been included that are necessary to make the financial statements not misleading. All of these adjustments that are material are of a normal and recurring nature. Our operating results for the three months ended March 31, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2017 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 includes a description of our significant accounting policies. Revenue Recognition In May 2014, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard, ASC 606 Revenue from Contracts with Customers , which requires recognition of revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. The new standard supersedes U.S. GAAP guidance on revenue recognition and requires the use of more estimates and judgments than the former standards. The new revenue standard became effective for us on January 1, 2018, and was adopted using the modified retrospective method. The adoption of the new revenue standard as of January 1, 2018, did not change our revenue recognition as the majority of our revenues continue to be recognized when the customer takes control of our product. As we did not identify any accounting changes that impacted the amount of reported revenues with respect to our product revenues or licensing agreements, no adjustment to retained earnings was required upon adoption. In accordance with the standard, revenue is measured based on consideration transferred as specified in a contract with a customer, and excludes any sales incentives or rebates. We recognize revenue when it satisfies a performance obligation by transferring control over a product or service to a customer. We recognize revenues following the five step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligations. Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which we generate our revenue. Product sales – Product sales are tracked in two reportable segments – Drug Products and Concentrate Products. We account for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and concentrate products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales. For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales. In instances where regulatory approval of the product has not been established and we do not have sufficient experience with the foreign regulatory body to conclude that regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time that control of the product transfers to the customer. We have received upfront fees under two distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”) are recognized as revenue over the estimated term of the distribution and license agreement as regulatory approval was not received and we did not have sufficient experience in China to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter are recognized as revenue at the point in time that the estimated product sales under the agreement occur. For the business under our distribution agreement with Baxter Healthcare Corporation (the “Baxter Agreement”) and for the majority of our international customers we recognize revenue at the shipping point, which is generally our plant or warehouse. For other business, we recognize revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms averaging 45 days. Disaggregation of revenue In the following table, revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of US dollars ($) Three Months Ended March 31, 2018 Products By Geographic Area Total U.S. Rest of World Drug Revenue Segment License Fee – Over time $ 68 $ - $ 68 Concentrate Products Product Sales – Point-in-time 14,376 12,472 1,904 License Fee – Point-in-time 504 504 - Total Concentrate Products 12,976 1,904 Net Revenue $ $ $ Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) March 31, 2018 December 31, 2017 Receivables, which are included in "Trade and other receivables" $ 5,684 $ 5,544 Contract liabilities $ 16,151 $ 16,723 There were no impairment losses recognized related to any receivables arising from our contracts with customers for the quarter ending March 31, 2018. For the three months ended March 31, 2018, we had no material bad-debt expense and there were no material contract assets recorded on the condensed consolidated balance sheet as of March 31, 2018. We do not generally accept returns of our concentrate products and no reserve for returns of concentrate products was established as of March 31, 2018 or December 31, 2017. The contract liabilities primarily relate to upfront payments / consideration received from customers that are received in advance of the customer assuming control of the related products. Transaction price allocated to remaining performance obligations For the three months ended March 31, 2018, revenue recognized from performance obligations related to prior periods was not material. Revenue expected to be recognized in any future year related to remaining performance obligations, excluding revenue pertaining to contracts that have an original expected duration of one year or less, contracts where revenue is recognized as invoiced and contracts with variable consideration related to undelivered performance obligations, totaled $16,151,000 as of March 31, 2018. The amount relates primarily to upfront payments / consideration received from customers that are received in advance of the customer assuming control of the related products. We apply the practical expedient in paragraph 606-10-50-14 and do not disclose information about remaining performance obligations that have original expected durations of one year or less. The Baxter Agreement includes minimum commitments of product sales over the duration of the agreement. Unfulfilled performance obligations related to the Baxter Agreement are product sales of $12,742,000 through expiration of the agreement on October 2, 2024. Cash and Cash Equivalents We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents. Investments Available for Sale Investments Available for Sale are short-term investments, consisting of investments in short-term notes and bonds and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy). The portfolio generally consists of high credit quality short-term debt instruments. These instruments are subject to changes in fair market value due primarily to changes in interest rates. The fair value of these investments was $24,821,682 as of March 31, 2018. Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss). Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense. Gross unrealized losses were $216,256 and gross unrealized gains were $26,260 as of March 31, 2018. There were realized gains of $1,425 and realized losses of $4,417 in the first quarter of 2018. The Company has evaluated the near term interest rate environment and the expected holding period of the investments along with the duration of the portfolio assets in assessing the severity and duration of potential impairments. Based on our evaluation, the Company does not consider those investments to be other-than-temporarily impaired at March 31, 2018. Reclassification During the three months ended March 31, 2018 the Company reclassified $2.3 million of its inventory from a current to a non-current asset and reclassified $2.3 million of its deferred license revenue from long-term liabilities to current liabilities. Research and Product Development We recognize research and product development expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products aggregating approximately $1.7 million and $1.2 million for the three months ended March 31, 2018 and 2017, respectively. Share Based Compensation We measure the cost of employee and non-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. Net Earnings Per Share We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period. Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect. The calculation of basic weighted average shares outstanding excludes 480,000 shares of unvested restricted stock for the three months ended March 31, 2018 and 2017, respectively, and 6,881,001 and 7,706,501 of unvested stock options for the three months ended March 31, 2018 and 2017, respectively. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Basic Weighted Average Shares Outstanding 51,288,424 50,686,044 Effect of Dilutive Securities — — Diluted Weighted Average Shares Outstanding 51,288,424 50,686,044

Inventory

Inventory	3 Months Ended
	Mar. 31, 2018
Inventory
Inventory	5. Inventory Components of inventory, net of reserves as of March 31, 2018 and December 31, 2017 are as follows: March 31, December 31, 2018 2017 Raw Materials $ 9,403,198 $ 10,604,232 Work in Process 124,534 212,505 Finished Goods 1,990,023 2,807,399 Total $ 11,517,755 $ 13,624,136 A As of March 31, 2018, the Company classified $6,007,601 of inventory as non-current all of which related to the active pharmaceutical ingredient for Triferic. As of March 31, 2018, we had total Triferic finished goods inventory aggregating $5,903,000 against which we had reserved $5,508,000. Additionally, inventory reserves will have to be recognized if the Company is unable to use its Triferic inventory before its shelf life expires.

Baxter Distribution Agreement

Baxter Distribution Agreement	3 Months Ended
	Mar. 31, 2018
Baxter Distribution Agreement
Baxter Distribution Agreement	6. Baxter Distribution Agreement As of October 2, 2014, we entered into the Baxter Agreement, 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 Baxter Agreement does not include any of our drug products. We 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 Baxter Agreement, Baxter has agreed not to manufacture or sell any competitive concentrate products in the United States hemodialysis market, other than specified products.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2018
SUBSEQUENT EVENT.
Subsequent Events	7. Subsequent Events Settlement Agreement On August 7, 2018, the Company entered into a confidential settlement agreement and mutual release (the “Settlement Agreement”) with its former Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO) and a former and then serving director. The Company agreed to: (i) pay the Company’s former CEO, former CFO, a former director and a then serving director a total of $1,500,000, one-half of which was paid at execution and the remainder of which will be paid in nine equal installments of $83,333; (ii) pay $30,000 to the then serving director (who then agreed to resign as a director); (iii) accelerate the vesting of options held by the Company’s former CEO and former CFO as of the date of their terminations; and (iv) grant an extended option exercise period for vested options. The Company’s former CEO, former CFO, a former director and the resigning director agreed to certain standstill covenants for a period of approximately five years and agreed to forfeit a total of 313,600 shares of restricted stock. Litigation Circuit Court for Oakland County, Michigan Following the Board’s termination of the Company’s former CEO on May 22, 2018, and in response to his continued assertion that he remained the duly appointed Chief Executive Officer of the Company, on May 23, 2018, the Company filed a complaint in the Oakland County Circuit Court in Michigan (“State Court”) seeking declaratory relief and a temporary restraining order. On May 24, 2018, the Board terminated its then-serving CFO. Following the State Court-ordered mediation, the Company, its former CEO, former CFO and a former and then current director, agreed to a term sheet (the “Term Sheet”) that outlined the terms of withdrawal of the State Court proceeding while the parties continued to litigate their claims in the Federal Court actions described below. On July 11, 2018, the State Court entered a stipulated order permitting the Company to withdraw its complaint in accordance with the Term Sheet. On July 17, 2018, the lawsuit in the State Court action was dismissed and closed. United States District Court for the Eastern District of Michigan On June 13, 2018, the Company’s former CEO and CFO filed a complaint in the United States District Court for the Eastern District of Michigan (“Federal Court”) against the Company and certain directors (collectively, the “Defendants”). The complaint requested that the Federal Court reinstate the former CEO to his former position of Chief Executive Officer, reinstate the former CFO to his former position of Chief Financial Officer and order the Defendants to pay all costs associated with the matter. The complaint alleged that the Defendants possibly violated their duties of loyalty and care to the Company; rules under the Regulation Fair Disclosure; and various federal securities laws, including Section 10(b) of the Exchange Act and SEC Rule 10b-5. On July 2, 2018, the Company filed an answer and counterclaim against the Company’s former CEO, former CFO, a former director and a then-serving director. On August 7, 2018, the parties entered into the Settlement Agreement by which the parties agreed to dismiss the Federal Court action with prejudice. As of the date of this Quarterly Report, the Federal Court has not yet entered an order of dismissal in the Federal Court action. SEC Inquiry As a follow up to its prior inquiry letters, the Company received further correspondence and a subpoena from the SEC during the third quarter requesting certain information generally with respect to the status of CMS’s determination of separate reimbursement status for Triferic and the Company’s prior description prior decision not to actively market and sell Triferic without such separate reimbursement, as well as requests for information with respect to the Board’s termination of the Company’s former CEO. The Board and management are actively cooperating with the SEC investigation. Whistleblower Complaint & Independent Investigation On May 17, 2018, the Company’s former CEO and former CFO filed a whistleblower complaint with the SEC alleging that certain of its directors violated their fiduciary duties of loyalty and care to the Company, rules under Regulation FD and various federal securities laws. The Board’s Audit Committee has engaged independent counsel to conduct an independent investigation into the allegations set forth in the whistleblower complaint, as well as a related shareholder demand. The Board and management are actively cooperating with the investigation of the independent counsel. Shareholder Class Action Lawsuit The Company is aware of one purported class action lawsuit naming the Company and its former CEO and former CFO as defendants. The complaint, which was filed on July 27, 2018 in the United States District Court for the Eastern District of New York, alleges that, from the period March 16, 2018 through June 26, 2018, the defendants violated certain federal securities laws by disseminating false and misleading information. The lawsuit seeks damages sustained by the class and an award of plaintiffs’ costs and attorneys’ fees. As of the date of this Quarterly Report, no lead plaintiff has been appointed, no class has been certified and the Company has not been served with the complaint.

Summary of Significant Accoun15

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2018
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. All intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2017 has been derived from our audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of our management, all adjustments have been included that are necessary to make the financial statements not misleading. All of these adjustments that are material are of a normal and recurring nature. Our operating results for the three months ended March 31, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2017 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 includes a description of our significant accounting policies.
Revenue Recognition	Revenue Recognition In May 2014, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard, ASC 606 Revenue from Contracts with Customers , which requires recognition of revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. The new standard supersedes U.S. GAAP guidance on revenue recognition and requires the use of more estimates and judgments than the former standards. The new revenue standard became effective for us on January 1, 2018, and was adopted using the modified retrospective method. The adoption of the new revenue standard as of January 1, 2018, did not change our revenue recognition as the majority of our revenues continue to be recognized when the customer takes control of our product. As we did not identify any accounting changes that impacted the amount of reported revenues with respect to our product revenues or licensing agreements, no adjustment to retained earnings was required upon adoption. In accordance with the standard, revenue is measured based on consideration transferred as specified in a contract with a customer, and excludes any sales incentives or rebates. We recognize revenue when it satisfies a performance obligation by transferring control over a product or service to a customer. We recognize revenues following the five step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligations. Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which we generate our revenue. Product sales – Product sales are tracked in two reportable segments – Drug Products and Concentrate Products. We account for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and concentrate products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales. For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales. In instances where regulatory approval of the product has not been established and we do not have sufficient experience with the foreign regulatory body to conclude that regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time that control of the product transfers to the customer. We have received upfront fees under two distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”) are recognized as revenue over the estimated term of the distribution and license agreement as regulatory approval was not received and we did not have sufficient experience in China to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter are recognized as revenue at the point in time that the estimated product sales under the agreement occur. For the business under our distribution agreement with Baxter Healthcare Corporation (the “Baxter Agreement”) and for the majority of our international customers we recognize revenue at the shipping point, which is generally our plant or warehouse. For other business, we recognize revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms averaging 45 days. Disaggregation of revenue In the following table, revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of US dollars ($) Three Months Ended March 31, 2018 Products By Geographic Area Total U.S. Rest of World Drug Revenue Segment License Fee – Over time $ 68 $ - $ 68 Concentrate Products Product Sales – Point-in-time 14,376 12,472 1,904 License Fee – Point-in-time 504 504 - Total Concentrate Products 12,976 1,904 Net Revenue $ $ $ Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) March 31, 2018 December 31, 2017 Receivables, which are included in "Trade and other receivables" $ 5,684 $ 5,544 Contract liabilities $ 16,151 $ 16,723 There were no impairment losses recognized related to any receivables arising from our contracts with customers for the quarter ending March 31, 2018. For the three months ended March 31, 2018, we had no material bad-debt expense and there were no material contract assets recorded on the condensed consolidated balance sheet as of March 31, 2018. We do not generally accept returns of our concentrate products and no reserve for returns of concentrate products was established as of March 31, 2018 or December 31, 2017. The contract liabilities primarily relate to upfront payments / consideration received from customers that are received in advance of the customer assuming control of the related products. Transaction price allocated to remaining performance obligations For the three months ended March 31, 2018, revenue recognized from performance obligations related to prior periods was not material. Revenue expected to be recognized in any future year related to remaining performance obligations, excluding revenue pertaining to contracts that have an original expected duration of one year or less, contracts where revenue is recognized as invoiced and contracts with variable consideration related to undelivered performance obligations, totaled $16,151,000 as of March 31, 2018. The amount relates primarily to upfront payments / consideration received from customers that are received in advance of the customer assuming control of the related products. We apply the practical expedient in paragraph 606-10-50-14 and do not disclose information about remaining performance obligations that have original expected durations of one year or less. The Baxter Agreement includes minimum commitments of product sales over the duration of the agreement. Unfulfilled performance obligations related to the Baxter Agreement are product sales of $12,742,000 through expiration of the agreement on October 2, 2024.
Cash and Cash Equivalents	Cash and Cash Equivalents We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents.
Investments Available for Sale	Investments Available for Sale Investments Available for Sale are short-term investments, consisting of investments in short-term notes and bonds and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy). The portfolio generally consists of high credit quality short-term debt instruments. These instruments are subject to changes in fair market value due primarily to changes in interest rates. The fair value of these investments was $24,821,682 as of March 31, 2018. Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss). Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense. Gross unrealized losses were $216,256 and gross unrealized gains were $26,260 as of March 31, 2018. There were realized gains of $1,425 and realized losses of $4,417 in the first quarter of 2018. The Company has evaluated the near term interest rate environment and the expected holding period of the investments along with the duration of the portfolio assets in assessing the severity and duration of potential impairments. Based on our evaluation, the Company does not consider those investments to be other-than-temporarily impaired at March 31, 2018.
Reclassification	Reclassification During the three months ended March 31, 2018 the Company reclassified $2.3 million of its inventory from a current to a non-current asset and reclassified $2.3 million of its deferred license revenue from long-term liabilities to current liabilities.
Research and Product Development	Research and Product Development We recognize research and product development expenses as incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products aggregating approximately $1.7 million and $1.2 million for the three months ended March 31, 2018 and 2017, respectively.
Share Based Compensation	Share Based Compensation We measure the cost of employee and non-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.
Net Earnings Per Share	Net Earnings Per Share We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period. Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect. The calculation of basic weighted average shares outstanding excludes 480,000 shares of unvested restricted stock for the three months ended March 31, 2018 and 2017, respectively, and 6,881,001 and 7,706,501 of unvested stock options for the three months ended March 31, 2018 and 2017, respectively. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were: Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Basic Weighted Average Shares Outstanding 51,288,424 50,686,044 Effect of Dilutive Securities — — Diluted Weighted Average Shares Outstanding 51,288,424 50,686,044

Restatement of the Unaudited 16

Restatement of the Unaudited Consolidated Financial Statements (Tables)	3 Months Ended
	Mar. 31, 2018
Restatement of the Unaudited Consolidated Financial Statements
Schedule of Restatement for the Unaudited Consolidated Financial Statements	The effect of the restatement on the Company’s unaudited condensed consolidated balance sheet as of March 31, 2018 are as follows: March 31, 2018 As Previously Reported Restatement Adjustment As Restated Inventory (1) $ 8,544,854 $ (3,034,700) $ 5,510,154 Total Current Assets (1) 44,245,771 (3,034,700) 41,211,071 Non-Current Inventory (1) 3,722,901 2,284,700 6,007,601 Total Assets 51,956,679 (750,000) 51,206,679 Accrued Liabilities 4,191,501 (1,000,000) 3,191,501 Current Portion of Deferred Revenue (1) - 2,285,932 2,285,932 Total Current Liabilities (1) 8,438,920 1,285,932 9,724,852 Deferred Revenue (1) 16,150,609 (2,285,932) 13,864,677 Total Liabilities (1) 24,589,529 (1,000,000) 23,589,529 Accumulated Deficit (246,791,897) 980,000 (245,811,897) Total Shareholders’ Equity 27,367,150 250,000 27,617,150 Total Liabilities and Shareholders’ Equity 51,956,679 (750,000) 51,206,679 (1) Includes the reclassification of $2.3 million of its inventory from a current asset to a non-current asset and $2.3 million of its deferred license revenue from long-term liabilities to current liabilities. The effect of the restatement on the Company’s unaudited condensed consolidated statement of operations for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Cost of Sales $ 14,919,072 $ 750,000 $ 15,669,072 Gross Profit 29,507 (750,000) (720,493) Selling, General and Administrative 5,061,955 (1,730,000) 3,331,955 Operating Loss (6,698,804) 980,000 (5,718,804) Net Loss (6,529,521) 980,000 (5,549,521) Basic and Diluted Loss per Share (0.13) 0.02 (0.11) Basic and Diluted Shares 51,288,424 - 51,288,424 The effect of the restatement on the Company’s unaudited condensed consolidated statement of comprehensive loss for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Comprehensive Loss $ (6,722,001) $ 980,000 $ (5,742,001) The effect of the restatement on the Company’s unaudited condensed consolidated statement of changes in shareholders’ equity for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Common Stock $ 274,386,910 $ (730,000) $ 273,656,910 Total shareholders' equity as of March 31, 2018 27,367,150 250,000 27,617,150 The effect of the restatement on the Company’s unaudited condensed consolidated statement of cash flows for the three months ended March 31, 2018 are as follows: For the Three Months Ended March 31, 2018 As Previously Reported Restatement Adjustment As Restated Net Loss $ (6,529,521) $ 980,000 $ (5,549,521) Stock-Based Compensation 1,176,003 (730,000) 446,003 Increase in Inventory Reserves 1,296,954 750,000 2,046,954 Decrease in Other Liabilities (494,969) (1,000,000) (1,494,969) Cash Used In Operating Activities (4,604,561) - (4,604,561)

Summary of Significant Accoun17

Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2018
Summary of Significant Accounting Policies
Disaggregation Of Revenue	In thousands of US dollars ($) Three Months Ended March 31, 2018 Products By Geographic Area Total U.S. Rest of World Drug Revenue Segment License Fee – Over time $ 68 $ - $ 68 Concentrate Products Product Sales – Point-in-time 14,376 12,472 1,904 License Fee – Point-in-time 504 504 - Total Concentrate Products 12,976 1,904 Net Revenue $ $ $
Contract Balances	In thousands of US dollars ($) March 31, 2018 December 31, 2017 Receivables, which are included in "Trade and other receivables" $ 5,684 $ 5,544 Contract liabilities $ 16,151 $ 16,723
Schedule of weighted average shares outstanding used in calculating basic and diluted earnings per share	Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Basic Weighted Average Shares Outstanding 51,288,424 50,686,044 Effect of Dilutive Securities — — Diluted Weighted Average Shares Outstanding 51,288,424 50,686,044

Inventory (Tables)

Inventory (Tables)	3 Months Ended
	Mar. 31, 2018
Inventory
Schedule components of inventory	March 31, December 31, 2018 2017 Raw Materials $ 9,403,198 $ 10,604,232 Work in Process 124,534 212,505 Finished Goods 1,990,023 2,807,399 Total $ 11,517,755 $ 13,624,136

Description of Business (Detail

Description of Business (Details)	12 Months Ended
	Dec. 31, 2017
Description of Business
Percentage of supply in domestic market	25

Going Concern (Details)

Going Concern (Details) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Dec. 31, 2017	Dec. 31, 2016
Going Concern
Cash and Cash Equivalents	$ 3,278,087	$ 11,973,820	$ 8,406,917	$ 17,180,594
Investments Available for Sale	24,821,682		24,648,459
Working Capital Net	31,500,000
Accumulated Deficit	(245,811,897)		$ (240,262,376)
Net cash used in operating activities	$ (4,604,561)	$ (5,076,976)

Restatement of the Unaudited 21

Restatement of the Unaudited Consolidated Financial Statements (Details) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Dec. 31, 2017
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Inventory	$ 5,510,154		$ 7,637,384
Total Current Assets	41,211,071		48,828,318
Non-Current Inventory	6,007,601		5,986,752
Total Assets	51,206,679		58,779,640
Accrued Liabilities	3,191,501		4,715,712
Current Portion of Deferred Revenue	2,285,932
Total Current Liabilities	9,724,852		9,143,174
Deferred Revenue	13,864,677
Total Liabilities	23,589,529		25,866,492
Accumulated Deficit	(245,811,897)		(240,262,376)
Total Shareholders’ Equity	27,617,150		32,913,148
Total Liabilities and Shareholders’ Equity	51,206,679		58,779,640
Cost of Sales	15,669,072	$ 12,234,782
Gross Profit	(720,493)	2,357,472
Selling, General and Administrative	3,331,955	6,100,715
Operating Loss	(5,718,804)	(4,958,094)
Net Loss	$ (5,549,521)	$ (4,742,023)
Basic and Diluted Net Loss per Share	$ (0.11)	$ (0.09)
Basic and Diluted Weighted Average Shares Outstanding	51,288,424	50,686,044
Comprehensive Loss	$ (5,742,001)	$ (4,629,516)
Common Stock	273,656,910		$ 273,210,907
Net Loss	(5,549,521)	(4,742,023)
Stock-Based Compensation	446,003	2,259,316
Increase in Inventory Reserves	2,046,954
Decrease in Other Liabilities	(1,494,969)	2,160,268
Cash Used In Operating Activities	(4,604,561)	$ (5,076,976)
Reclassification of inventory from a current asset to non-current	2,300,000
Reclassification of deferred license revenue from long term liabilities to current liabilities	2,300,000
As Previously Reported [Member]
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Inventory	8,544,854
Total Current Assets	44,245,771
Non-Current Inventory	3,722,901
Total Assets	51,956,679
Accrued Liabilities	4,191,501
Total Current Liabilities	8,438,920
Deferred Revenue	16,150,609
Total Liabilities	24,589,529
Accumulated Deficit	(246,791,897)
Total Shareholders’ Equity	27,367,150
Total Liabilities and Shareholders’ Equity	51,956,679
Cost of Sales	14,919,072
Gross Profit	29,507
Selling, General and Administrative	5,061,955
Operating Loss	(6,698,804)
Net Loss	$ (6,529,521)
Basic and Diluted Net Loss per Share	$ (0.13)
Basic and Diluted Weighted Average Shares Outstanding	51,288,424
Comprehensive Loss	$ (6,722,001)
Common Stock	274,386,910
Net Loss	(6,529,521)
Stock-Based Compensation	1,176,003
Increase in Inventory Reserves	1,296,954
Decrease in Other Liabilities	(494,969)
Cash Used In Operating Activities	(4,604,561)
Restatement Adjustment [Member]
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Inventory	(3,034,700)
Total Current Assets	(3,034,700)
Non-Current Inventory	2,284,700
Total Assets	(750,000)
Accrued Liabilities	(1,000,000)
Current Portion of Deferred Revenue	2,285,932
Total Current Liabilities	1,285,932
Deferred Revenue	(2,285,932)
Total Liabilities	(1,000,000)
Accumulated Deficit	980,000
Total Shareholders’ Equity	250,000
Total Liabilities and Shareholders’ Equity	(750,000)
Cost of Sales	750,000
Gross Profit	(750,000)
Selling, General and Administrative	(1,730,000)
Operating Loss	980,000
Net Loss	$ 980,000
Basic and Diluted Net Loss per Share	$ 0.02
Comprehensive Loss	$ 980,000
Common Stock	(730,000)
Net Loss	980,000
Stock-Based Compensation	(730,000)
Increase in Inventory Reserves	750,000
Decrease in Other Liabilities	$ (1,000,000)

Summary of Significant Accoun22

Summary of Significant Accounting Policies - Revenue Recognition, PPE, Licensing and Research (Details)	3 Months Ended
	Mar. 31, 2018USD ($)segment	Mar. 31, 2017USD ($)	Dec. 31, 2017USD ($)
Revenue Recognition
Number of reportable segments | segment	2
Customers average payment term	30 days
Distributors average payment term	45 days
Investments Available for Sale
Fair value of investments	$ 24,821,682		$ 24,648,459
Gross unrealized losses	216,256
Gross unrealized gains	26,260
Realized gains	1,425
Realized losses	4,417
Reclassification of inventory from a current asset to non-current	2,300,000
Reclassification of deferred license revenue from long term liabilities to current liabilities	2,300,000
Research and Development
Product development and research costs	$ 1,666,356	$ 1,214,851

Summary of Significant Accoun23

Summary of Significant Accounting Policies - Disaggregation Of Revenue (Details) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Net Revenue	$ 14,948,579	$ 14,592,254
United States [Member]
Net Revenue	12,976,000
Rest Of World [Member]
Net Revenue	1,972,000
Concentrate Products [Member]
Net Revenue	14,880,000
Concentrate Products [Member] | United States [Member]
Net Revenue	12,976,000
Concentrate Products [Member] | Rest Of World [Member]
Net Revenue	1,904,000
Transferred at Point in Time [Member] | License Fee [Member] | Concentrate Products [Member]
Net Revenue	504,000
Transferred at Point in Time [Member] | License Fee [Member] | Concentrate Products [Member] | United States [Member]
Net Revenue	504,000
Transferred at Point in Time [Member] | Product Sales [Member] | Concentrate Products [Member]
Net Revenue	14,376,000
Transferred at Point in Time [Member] | Product Sales [Member] | Concentrate Products [Member] | United States [Member]
Net Revenue	12,472,000
Transferred at Point in Time [Member] | Product Sales [Member] | Concentrate Products [Member] | Rest Of World [Member]
Net Revenue	1,904,000
Transferred over Time [Member] | License Fee [Member] | Drug Revenue [Member]
Net Revenue	68,000
Transferred over Time [Member] | License Fee [Member] | Drug Revenue [Member] | Rest Of World [Member]
Net Revenue	$ 68,000

Summary of Significant Accoun24

Summary of Significant Accounting Policies - Contract Balances and Transaction price allocated to remaining performance obligations (Details) - USD ($)	3 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Other Receivables	$ 5,684,000	$ 5,544,000
Contract liabilities	16,151,000	$ 16,723,000
Impairment losses related to receivables arising from contracts with customers	0
Bad-debt expense	0
Contract assets	$ 0
Remaining performance obligation practical expedient	true
Concentrate Products [Member]
Reserve for returns	$ 0

Summary of Significant Accoun25

Summary of Significant Accounting Policies - Net Earnings Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Weighted average shares outstanding used in calculating basic and diluted earnings per share
Basic Weighted Average Shares Outstanding	51,288,424	50,686,044
Diluted Weighted Average Shares Outstanding	51,288,424	50,686,044
Stock options
Weighted average shares outstanding used in calculating basic and diluted earnings per share
Securities excluded from diluted loss per share calculation	6,881,001	7,706,501
Restricted stock
Weighted average shares outstanding used in calculating basic and diluted earnings per share
Securities excluded from diluted loss per share calculation	480,000	480,000

Inventory (Details)

Inventory (Details) - USD ($)	Mar. 31, 2018	Dec. 31, 2017
Inventory [Line Items]
Raw Materials	$ 9,403,198	$ 10,604,232
Work in Process	124,534	212,505
Finished Goods	1,990,023	2,807,399
Total	11,517,755	13,624,136
Inventory, Noncurrent	6,007,601	$ 5,986,752
Triferic Finished Goods [Member]
Inventory [Line Items]
Finished goods inventory	5,903,000
Inventory reserves	$ 5,508,000

Baxter Distribution Agreement (

Baxter Distribution Agreement (Details)	Oct. 02, 2014
Baxter Healthcare Organization
Distribution agreement term	10 years

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent event	Aug. 07, 2018USD ($)item	Aug. 07, 2018itemshares
SUBSEQUENT EVENTS
Number of litigation settlement amount payments | item	9	9
Period for payment of remaining litigation settlement amount		5 years
Litigation with Chiconi, Klema, Bagley and Boyd
SUBSEQUENT EVENTS
Litigation settlement amount	$ 1,500,000
Payment of litigation settlement amount	83,333
Litigation with Chiconi, Klema, Bagley and Boyd | Boyd [Member]
SUBSEQUENT EVENTS
Payment of litigation settlement amount	$ 30,000
Restricted stock | Boyd [Member]
SUBSEQUENT EVENTS
Shares forfeited | shares		313,600