Rockwell Medical (RMTI) 10-Q 10 Nov 14 2014 Q3 Quarterly report Financial data

Document_and_Entity_Informatio

Document and Entity Information	9 Months Ended
	Sep. 30, 2014	Oct. 24, 2014
Document and Entity Information	'	'
Entity Registrant Name	'ROCKWELL MEDICAL, INC.	'
Entity Central Index Key	'0001041024	'
Document Type	'10-Q	'
Document Period End Date	30-Sep-14	'
Amendment Flag	'false	'
Current Fiscal Year End Date	'--12-31	'
Entity Current Reporting Status	'Yes	'
Entity Filer Category	'Accelerated Filer	'
Entity Common Stock, Shares Outstanding	'	43,603,407
Document Fiscal Year Focus	'2014	'
Document Fiscal Period Focus	'Q3	'

CONSOLIDATED_BALANCE_SHEETS

CONSOLIDATED BALANCE SHEETS (USD $)	Sep. 30, 2014	Dec. 31, 2013
ASSETS	'	'
Cash and Cash Equivalents	$3,016,837	$11,881,451
Investments Available for Sale	9,017,395	12,034,622
Accounts Receivable, net of a reserve of $52,000 in 2014 and $37,000 in 2013	4,189,666	4,578,319
Inventory	2,981,506	2,799,648
Other Current Assets	688,475	623,734
Total Current Assets	19,893,879	31,917,774
Property and Equipment, net	1,615,320	1,648,949
Intangible Assets	374,443	499,715
Goodwill	920,745	920,745
Other Non-current Assets	1,067,800	1,374,941
Total Assets	23,872,187	36,362,124
LIABILITIES AND SHAREHOLDERS' EQUITY	'	'
Note Payable	7,962,819	2,308,145
Accounts Payable	5,171,391	8,686,153
Accrued Liabilities	3,816,884	6,647,828
Customer Deposits	329,117	207,545
Total Current Liabilities	17,280,211	17,849,671
Long Term Debt	12,051,824	17,916,914
Shareholders' Equity:	'	'
Common Shares, no par value, 41,015,392 and 40,110,661 shares issued and outstanding	164,056,146	154,457,878
Common Share Purchase Warrants, 838,071 and 983,071 warrants issued and outstanding	4,225,669	4,895,811
Accumulated Deficit	-173,734,079	-158,790,569
Accumulated Other Comprehensive Income	-7,584	32,419
Total Shareholders' Equity (Deficit)	-5,459,848	595,539
Total Liabilities And Shareholders' Equity	$23,872,187	$36,362,124

CONSOLIDATED_BALANCE_SHEETS_Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)	Sep. 30, 2014	Dec. 31, 2013
CONSOLIDATED BALANCE SHEETS	'	'
Allowance for reserve, accounts receivable (in dollars)	$52,000	$37,000
Common Shares, par value (in dollars per share)	$0	$0
Common Shares, shares issued	41,015,392	40,110,661
Common Shares, shares outstanding	41,015,392	40,110,661
Common Share Purchase Warrants, issued	838,071	983,071
Common Share Purchase Warrants, outstanding	838,071	983,071

CONSOLIDATED_INCOME_STATEMENTS

CONSOLIDATED INCOME STATEMENTS (USD $)	3 Months Ended		9 Months Ended
	Sep. 30, 2014	Sep. 30, 2013	Sep. 30, 2014	Sep. 30, 2013
CONSOLIDATED INCOME STATEMENTS	'	'	'	'
Sales	$13,743,778	$13,094,381	$39,740,791	$38,414,919
Cost of Sales	11,473,961	11,461,100	33,772,125	33,815,593
Gross Profit	2,269,817	1,633,281	5,968,666	4,599,326
Selling, General and Administrative	4,098,835	3,386,367	12,403,240	10,541,124
Research and Product Development	1,301,824	10,611,219	6,103,716	33,588,458
Operating Income (Loss)	-3,130,842	-12,364,305	-12,538,290	-39,530,256
Interest and Investment Income, net	55,263	13,546	199,113	28,784
Interest Expense	892,027	857,505	2,604,333	949,735
Income (Loss) Before Income Taxes	-3,967,606	-13,208,264	-14,943,510	-40,451,207
Income Tax Expense	0	'	0	'
Net Income (Loss)	($3,967,606)	($13,208,264)	($14,943,510)	($40,451,207)
Basic Earnings (Loss) per Share (in dollars per share)	($0.10)	($0.34)	($0.37)	($1.32)
Diluted Earnings (Loss) per Share (in dollars per share)	($0.10)	($0.34)	($0.37)	($1.32)

CONSOLIDATED_STATEMENTS_OF_COM

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (USD $)	3 Months Ended		9 Months Ended
	Sep. 30, 2014	Sep. 30, 2013	Sep. 30, 2014	Sep. 30, 2013
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)	'	'	'	'
Net Income (Loss)	($3,967,606)	($13,208,264)	($14,943,510)	($40,451,207)
Unrealized Gain on Available-for-Sale Investments	-58,848	4,332	-40,003	4,332
Comprehensive Income (Loss)	($4,026,454)	($13,203,932)	($14,983,513)	($40,446,875)

CONSOLIDATED_STATEMENTS_OF_CHA

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (USD $)	COMMON SHARES	Common share purchase warrants	ACCUMULATED DEFICIT	ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS)	Total
Balance at Dec. 31, 2013	$154,457,878	$4,895,811	($158,790,569)	$32,419	$595,539
Balance (purchase warrants in shares) at Dec. 31, 2013	'	983,071	'	'	983,071
Balance (in shares) at Dec. 31, 2013	40,110,661	'	'	'	40,110,661
Increase (Decrease) in Shareholders' Equity	'	'	'	'	'
Net (Loss)	'	'	-14,943,510	'	-14,943,510
Unrealized Gain (Loss) on Available-for-Sale Securities	'	'	'	-40,003	-40,003
Issuance of Common Shares	2,205,125	'	'	'	2,205,125
Issuance of Common Shares (in shares)	517,916	'	'	'	'
Exercise of Purchase Warrants	1,099,892	-670,142	'	'	429,750
Exercise of Purchase Warrants (in shares)	66,815	-145,000	'	'	'
Stock Option Based Expense	3,112,599	'	'	'	3,112,599
Restricted Stock Amortization	3,180,652	'	'	'	3,180,652
Restricted Stock Issuance (in shares)	320,000	'	'	'	'
Balance at Sep. 30, 2014	$164,056,146	$4,225,669	($173,734,079)	($7,584)	($5,459,848)
Balance (purchase warrants in shares) at Sep. 30, 2014	'	838,071	'	'	838,071
Balance (in shares) at Sep. 30, 2014	41,015,392	'	'	'	41,015,392

CONSOLIDATED_STATEMENTS_OF_CAS

CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)	9 Months Ended
	Sep. 30, 2014	Sep. 30, 2013
Cash Flows From Operating Activities:	'	'
Net Income (Loss)	($14,943,510)	($40,451,207)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:	'	'
Depreciation and Amortization	767,386	752,360
Share Based Compensation - Non-employee	'	1,435,344
Share Based Compensation- Employees	6,293,250	4,449,110
Amortization of Debt Issuance Costs	357,140	'
Non-cash Interest Expense	353,994	426,938
Loss on Disposal of Assets	4,827	15,500
Loss on Sale of Investments, net	1,223	'
Changes in Assets and Liabilities:	'	'
Decrease in Accounts Receivable	388,653	209,521
(Increase) in Inventory	-181,858	-164,526
Decrease (increase) in Other Assets	-317,194	606,263
(Decrease) in Accounts Payable	-3,514,762	-7,722,004
(Decrease) in Other Liabilities	-2,506,918	-2,079,489
Changes in Assets and Liabilities	-6,132,079	-9,150,235
Cash Used In Operating Activities	-13,297,769	-42,522,190
Cash Flows From Investing Activities:	'	'
Purchase of Investments Available for Sale	-2,000,000	-10,000,611
Sale of Investments Available for Sale	4,976,000	'
Purchase of Equipment	-613,311	-496,302
Proceeds on Sale of Assets	'	6,898
Cash Provided By (Used In) Investing Activities	2,362,689	-10,490,015
Cash Flows From Financing Activities:	'	'
Proceeds from the Issuance of Common Shares and Purchase Warrants	2,634,876	50,625,357
Proceeds from the Issuance of Notes Payable	'	20,000,000
Debt Issuance Costs	'	-1,109,776
Payments on Notes Payable and Capital Lease Obligations	-564,410	-2,280
Cash Provided By Financing Activities	2,070,466	69,513,301
Increase (Decrease) In Cash	-8,864,614	16,501,096
Cash At Beginning Of Period	11,881,451	4,711,730
Cash At End Of Period	3,016,837	21,212,826
Supplemental Cash Flow disclosure	'	'
Interest Paid	$1,906,022	$522,797

Description_of_Business

Description of Business	9 Months Ended
	Sep. 30, 2014
Description of Business	'
Description of Business	'
	1.  Description of Business
	Rockwell Medical, Inc. and Subsidiary (collectively, “we”, “our”, “us”, or the “Company”) is a fully-integrated pharmaceutical company targeting end-stage renal disease (“ESRD”) and chronic kidney disease (“CKD”) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.
	Rockwell’s lead investigational drug Triferic is currently under review by the U.S. Food and Drug Administration (“FDA”) for the treatment of iron replacement and maintenance of hemoglobin in dialysis patients. Triferic’s unique mode of action enables it to deliver iron to the bone marrow of dialysis patients in a physiological manner during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has successfully completed the efficacy trials of its Phase 3 clinical study program.
	Rockwell is preparing to launch its FDA approved generic drug Calcitriol to treat secondary hyperparathyroidism in dialysis patients.  Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market.
	Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.  As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream.  Rockwell has three manufacturing/distribution facilities located in the U.S.
	We are regulated by the FDA under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies.  We market products that have been approved for sale by the FDA.

Summary_of_Significant_Account

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2014
Summary of Significant Accounting Policies	'
Summary of Significant Accounting Policies	'
	2.  Summary of Significant Accounting Policies
	Basis of Presentation
	Our consolidated financial statements include our accounts and the accounts for our wholly owned subsidiary, Rockwell Transportation, Inc.  All intercompany balances and transactions have been eliminated in consolidation. The accompanying consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2013 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements.
	In the opinion of our management, all adjustments have been included 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 and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2013 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 includes a description of our significant accounting policies.
	Revenue Recognition
	We recognize revenue at the time we transfer title to our products to our customers, consistent with generally accepted accounting principles.  Generally, we recognize revenue when our products are delivered to our customer’s location consistent with our terms of sale.  We recognize revenue for international shipments when title has transferred consistent with standard terms of sale.
	We require certain customers, mostly international customers, to pay for product prior to the transfer of title to the customer.  Deposits received from customers and payments in advance for orders are recorded as liabilities under Customer Deposits until such time as orders are filled and title transfers to the customer consistent with our terms of sale.
	Cash and Cash Equivalents
	We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents.
	Investments Available for Sale
	Investments Available for Sale are short-term investments, consisting of investments in short term duration bond funds, and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy).  These funds generally hold high credit quality short term debt instruments.  These instruments are subject to changes in fair market value due primarily to changes in interest rates.  The fair value of these investments was $9,017,395 as of September 30, 2014.  Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss).  Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense.  Gross unrealized gains were $33,445 and gross unrealized losses were $41,029 as of September 30, 2014.  We had net realized losses of $1,223 for the nine months ended September 30, 2014.
	The Company evaluated the near term interest rate environment, the expected holding period of the investments along with the duration of the fund portfolios in assessing the severity and duration of the potential impairment. Based on that evaluation the Company does not consider those investments to be other-than-temporarily impaired at September 30, 2014.
	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, primarily Triferic, aggregating approximately $1.3 million and $10.6 million for the three months ended September 30, 2014 and 2013, respectively, and $6.1 million and $33.6 million for the nine months ended September 30, 2014 and 2013, respectively.  We completed Phase 3 efficacy trials related to Triferic in 2013.  We submitted our NDA for Triferic to the FDA on March 24, 2014 and paid the new drug application fee of $2,169,100.  Our initial fee waiver request as a small business was denied by the Small Business Administration but was later granted upon appeal.  The New Drug Application (“NDA”) fee was recognized as an expense in the first quarter of 2014, but that expense was reversed in the second quarter upon obtaining the waiver.  We recorded a receivable as of June 30, 2014 for the amount of the refund, which was subsequently received in the third quarter of 2014.
	Net Earnings Per Share
	We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period.  Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect.  The calculation of basic weighted average shares outstanding excludes unvested restricted stock. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were:
		Three Months	Three Months	Nine Months	Nine Months
		Ended	Ended	Ended	Ended
		September	September	September	September
		30, 2014	30, 2013	30, 2014	30, 2013
	Basic Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944
	Effect of Dilutive Securities	—	—	—	—
	Diluted Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944

Inventory

Inventory	9 Months Ended
	Sep. 30, 2014
Inventory	'
Inventory	'
	3.  Inventory
	Components of inventory as of September 30, 2014 and December 31, 2013 are as follows:
		September 30,		December 31,
		2014		2013
	Raw Materials	$	1,394,930	$	1,142,776
	Work in Process	207,434		254,714
	Finished Goods	1,379,142		1,402,158
	Total	$	2,981,506	$	2,799,648

Loans_Payable

Loans Payable	9 Months Ended
	Sep. 30, 2014
Loans Payable	'
Loans Payable	'
	4.  Loans Payable
	On June 14, 2013, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Technology III, L.P. (“Hercules”) pursuant to which the Company received a loan in the aggregate principal amount of $20.0 million.  The Company is required to repay the aggregate principal balance under the Loan Agreement in 30 equal monthly installments of principal and interest that commenced on September 1, 2014.
	The loan will mature and become due on March 1, 2017, subject to adjustment as provided below, and will bear interest at the greater of (i) 12.50% plus the prime rate as reported in The Wall Street Journal minus 3.25%, or (ii) 12.50%.  The Company was required to make monthly interest only payments through August 31, 2014.  Monthly principal and interest payments will be due on the loan following the interest only period through the maturity date. The loan may be prepaid without penalty and will mature and become due upon any change in control of the Company.  The Company paid debt issuance costs of $1.1 million including a fee of $0.2 million at closing to Hercules, which are recorded as a noncurrent asset, and is required to pay a fee of $1.1 million upon any prepayment or at maturity.  The $1.1 million fee due upon any prepayment or at maturity is accrued using the effective interest rate method over the life of the loan.  The effective interest rate of the loan at September 30, 2014 was 14.5%.  On October 2, 2014 the Company entered into an exclusive Distribution Agreement (the “Distribution Agreement”) with Baxter Healthcare Corporation (“Baxter”) as described below in Note 5 — Subsequent Events under which the Company is obligated to retire the Hercules debt within 180 days from the date of the Distribution Agreement.
	In connection with the loan, the Company granted Hercules a security interest in substantially all of the Company’s assets other than motor vehicles, real property and certain intellectual property and other interests.  The Loan Agreement provides for standard indemnification of Hercules and contains representations, warranties and non-financial covenants of the Company.  The Loan Agreement contains covenants that, among other things, limit the Company’s ability to incur additional indebtedness, transfer assets, acquire assets of or merge with another entity and pay dividends to the Company’s shareholders.  The Loan Agreement defines event of default, to include, among other events, the occurrence of an event that results in a material adverse effect upon the Company’s business operations, properties, assets or condition (financial or otherwise), the collateral or the perfection of the security interest, or the Company’s ability to perform its obligations under the Loan Agreement.
	As of September 30, 2014, the balance of the above debt matures as follows:
	2014(remainder of year)	$	2,332,436
	2015	7,624,034
	2016	8,645,024
	2017	834,095
	Total Principal Payable	$	19,435,589
	In addition to the principal payable, there is an end of term fee of $1.1 million of which $579,054 has been accrued for as of September 30, 2014.
	Interest accrued on the loan payable through September 30, 2014 was $202,454.

Subsequent_Events

Subsequent Events	9 Months Ended
	Sep. 30, 2014
Subsequent Events	'
Subsequent Events	'
	5.  Subsequent Events
	Warrant Exercise
	We received $8.0 million in cash in October 2014 from the exercise of 838,071 warrants to purchase common stock at $9.55 per share just prior to their expiration.  We issued 838,071 common shares upon exercise of the warrants.
	Private Placement of Common Shares
	On October 2, 2014, we entered into an Investment Agreement with Baxter under which we issued 1,316,944 common shares in conjunction with a private placement in exchange for $15.0 million at a per share price of $11.39, which was $2.21 above the share price at market close that day.
	Under the terms of the Investment Agreement, Baxter agreed not to transfer any of the common shares until at least one year following the purchase of the shares, and is prohibited from engaging in any short sales with respect to the shares for three years following the purchase of the shares.  In addition, until the earlier of (i) the end of the term of the Distribution Agreement or (ii) one year after the Company receives notice that Baxter and its affiliates no longer beneficially own the shares, Baxter will be bound by certain “standstill” provisions that prohibit Baxter from, among other things, beneficially owning more than 4.9% of the Company’s common stock, participating in a solicitation of proxies, granting a proxy other than to Company management, acting or seeking to control the Company’s management or board, or publicly proposing a business combination or extraordinary corporate transaction.  The Investment Agreement also contains customary representations and warranties and standard indemnification provisions.
	Distribution Agreement
	On October 2, 2014, we entered into the Distribution Agreement with Baxter, pursuant to which Baxter has become the Company’s exclusive agent for commercializing the Company’s hemodialysis concentrate and ancillary products in the United States and various foreign countries for an initial term of 10 years.  The Company retains sales, marketing and distribution rights for its hemodialysis concentrate products for its current international customers and in those countries in which the Company has 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.
	Following the signing of the Distribution Agreement, Baxter paid the Company $20 million in cash (the “Upfront Fee).  The Upfront Fee will be recognized as revenue in future periods over the term of the license based on sales projections over the term of the Distribution Agreement.
	During the initial transition period until Baxter assumes customer invoicing, which is expected to last until December 31, 2014, Rockwell will continue to recognize sales and invoice customers. We will provide Baxter with an equivalent economic value for the operating income related to those sales and will treat these payments as a reduction in revenue.  Once Baxter assumes invoicing, Rockwell revenue will be based on our contractual distributor pricing to Baxter.
	The Distribution Agreement requires Baxter to meet minimum annual purchase requirements (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.  Purchases that exceed the minimum requirement in a given year may be carried forward and applied to future years’ requirements. The Distribution Agreement also contains provisions governing the operating relationship between the parties, the Company’s 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 the Company 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, the Company would be obligated to repay a portion of the Upfront Fee and Facility Fee (described below) as follows: 50% if the event occurs prior to December 31, 2016, 33% if the event occurs in 2017 or 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 any product in the United States 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 requires the Company to prepay its outstanding secured long-term indebtedness within 180 days and prohibits the Company from entering into a subsequent contract encumbering the assets used in the Company’s concentrate business without the prior written consent of Baxter.
	Baxter has also agreed to pay the Company during the term of the Distribution Agreement $10 million (the “Facility Fee”) to build and operate a new manufacturing facility located in the Pacific time zone to service customers in the Western United States.  The Facility Fee will be reduced to the extent that the facility is not operational within 12 months after the start of construction.  Except for any leased components, the Company will own the facility when completed.
	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 be extended an additional five years at Baxter’s option at no additional cost.

Summary_of_Significant_Account1

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2014
Summary of Significant Accounting Policies	'
Basis of Presentation	'
	Basis of Presentation
	Our consolidated financial statements include our accounts and the accounts for our wholly owned subsidiary, Rockwell Transportation, Inc.  All intercompany balances and transactions have been eliminated in consolidation. The accompanying consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2013 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements.
	In the opinion of our management, all adjustments have been included 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 and nine months ended September 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2013 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 includes a description of our significant accounting policies.
Revenue Recognition	'
	Revenue Recognition
	We recognize revenue at the time we transfer title to our products to our customers, consistent with generally accepted accounting principles.  Generally, we recognize revenue when our products are delivered to our customer’s location consistent with our terms of sale.  We recognize revenue for international shipments when title has transferred consistent with standard terms of sale.
	We require certain customers, mostly international customers, to pay for product prior to the transfer of title to the customer.  Deposits received from customers and payments in advance for orders are recorded as liabilities under Customer Deposits until such time as orders are filled and title transfers to the customer consistent with our terms of sale.
Cash and Cash Equivalents	'
	Cash and Cash Equivalents
	We consider cash on hand, money market funds, unrestricted certificates of deposit and short term marketable securities with an original maturity of 90 days or less as cash and cash equivalents.
Investments Available for Sale	'
	Investments Available for Sale
	Investments Available for Sale are short-term investments, consisting of investments in short term duration bond funds, and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy).  These funds generally hold high credit quality short term debt instruments.  These instruments are subject to changes in fair market value due primarily to changes in interest rates.  The fair value of these investments was $9,017,395 as of September 30, 2014.  Unrealized holding gains or losses on these securities are included in accumulated other comprehensive income (loss).  Realized gains and losses, including declines in value judged to be other-than-temporary on available-for-sale securities are included as a component of other income or expense.  Gross unrealized gains were $33,445 and gross unrealized losses were $41,029 as of September 30, 2014.  We had net realized losses of $1,223 for the nine months ended September 30, 2014.
	The Company evaluated the near term interest rate environment, the expected holding period of the investments along with the duration of the fund portfolios in assessing the severity and duration of the potential impairment. Based on that evaluation the Company does not consider those investments to be other-than-temporarily impaired at September 30, 2014.
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, primarily Triferic, aggregating approximately $1.3 million and $10.6 million for the three months ended September 30, 2014 and 2013, respectively, and $6.1 million and $33.6 million for the nine months ended September 30, 2014 and 2013, respectively.  We completed Phase 3 efficacy trials related to Triferic in 2013.  We submitted our NDA for Triferic to the FDA on March 24, 2014 and paid the new drug application fee of $2,169,100.  Our initial fee waiver request as a small business was denied by the Small Business Administration but was later granted upon appeal.  The New Drug Application (“NDA”) fee was recognized as an expense in the first quarter of 2014, but that expense was reversed in the second quarter upon obtaining the waiver.  We recorded a receivable as of June 30, 2014 for the amount of the refund, which was subsequently received in the third quarter of 2014.
Net Earnings Per Share	'
	Net Earnings Per Share
	We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period.  Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect.  The calculation of basic weighted average shares outstanding excludes unvested restricted stock. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were:
		Three Months	Three Months	Nine Months	Nine Months
		Ended	Ended	Ended	Ended
		September	September	September	September
		30, 2014	30, 2013	30, 2014	30, 2013
	Basic Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944
	Effect of Dilutive Securities	—	—	—	—
	Diluted Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944

Summary_of_Significant_Account2

Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2014
Summary of Significant Accounting Policies	'
Schedule of weighted average shares outstanding used in calculating basic and diluted earnings per share	'
		Three Months	Three Months	Nine Months	Nine Months
		Ended	Ended	Ended	Ended
		September	September	September	September
		30, 2014	30, 2013	30, 2014	30, 2013
	Basic Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944
	Effect of Dilutive Securities	—	—	—	—
	Diluted Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944

Inventory_Tables

Inventory (Tables)	9 Months Ended
	Sep. 30, 2014
Inventory	'
Schedule components of inventory	'
		September 30,		December 31,
		2014		2013
	Raw Materials	$	1,394,930	$	1,142,776
	Work in Process	207,434		254,714
	Finished Goods	1,379,142		1,402,158
	Total	$	2,981,506	$	2,799,648

Loans_Payable_Tables

Loans Payable (Tables)	9 Months Ended
	Sep. 30, 2014
Loans Payable	'
Schedule of debt maturity	'
	2014(remainder of year)	$	2,332,436
	2015	7,624,034
	2016	8,645,024
	2017	834,095
	Total Principal Payable	$	19,435,589

Description_of_Business_10Q_De

Description of Business 10Q (Details)	Sep. 30, 2014
	facility
Description of Business	'
Number of US manufacturing and distribution facilities	3

Summary_of_Significant_Account3

Summary of Significant Accounting Policies 10Q (Details) (USD $)	3 Months Ended		9 Months Ended			0 Months Ended
	Sep. 30, 2014	Sep. 30, 2013	Sep. 30, 2014	Sep. 30, 2013	Dec. 31, 2013	Mar. 24, 2014
						Patents
Investments Available for Sale	'	'	'	'	'	'
Fair value of investments	$9,017,395	'	$9,017,395	'	$12,034,622	'
Gross unrealized gains	33,445	'	33,445	'	'	'
Gross unrealized losses	41,029	'	41,029	'	'	'
Net realized gains or losses	'	'	1,223	'	'	'
Research and Product Development	'	'	'	'	'	'
Product development and research costs	1,301,824	10,611,219	6,103,716	33,588,458	'	'
NDA review fee	'	'	'	'	'	$2,169,100

Summary_of_Significant_Account4

Summary of Significant Accounting Policies (Details 2)	3 Months Ended		9 Months Ended
	Sep. 30, 2014	Sep. 30, 2013	Sep. 30, 2014	Sep. 30, 2013
Weighted average shares outstanding used in calculating basic and diluted earnings per share	'	'	'	'
Basic Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944
Diluted Weighted Average Shares Outstanding	40,405,693	39,327,994	40,063,399	30,652,944

Inventory_Details

Inventory (Details) (USD $)	Sep. 30, 2014	Dec. 31, 2013
Inventory	'	'
Raw Materials	$1,394,930	$1,142,776
Work in Process	207,434	254,714
Finished Goods	1,379,142	1,402,158
Total	$2,981,506	$2,799,648

Loans_Payable_Details

Loans Payable (Details) (USD $)	9 Months Ended	0 Months Ended	9 Months Ended		9 Months Ended
	Sep. 30, 2013	Jun. 14, 2013	Sep. 30, 2014	Sep. 30, 2014	Sep. 30, 2014
		Loan Agreement	Loan Agreement	Loan Agreement	Loan Agreement
		item		Forecast	Prime rate
Notes payable	'	'	'	'	'
Aggregate principal amount	'	$20,000,000	'	'	'
Number of installments over which the loan is to be repaid	'	30	'	'	'
Maturity date	'	'	1-Mar-17	'	'
Spread added to reference rate under first condition (as a percent)	'	'	'	'	12.50%
Variable rate basis under first condition	'	'	'	'	'prime rate
Percentage point deducted from reference rate to compute variable rate under first condition	'	'	'	'	3.25%
Interest rate under second condition (as a percent)	'	'	12.50%	'	'
Debt issuance costs	1,109,776	1,100,000	'	'	'
Fee paid to Hercules	'	200,000	'	1,100,000	'
Fee due and accrued	'	'	1,100,000	'	'
Effective interest rate of loan (as a percent)	'	'	14.50%	'	'
Maturities of debt	'	'	'	'	'
2014 (remainder of year)	'	'	2,332,436	'	'
2015	'	'	7,624,034	'	'
2016	'	'	8,645,024	'	'
2017	'	'	834,095	'	'
Total Principal Payable	'	'	19,435,589	'	'
Interest accrued on the loan payable	'	'	$202,454	'	'

Subsequent_Events_Details

Subsequent Events (Details) (USD $)	9 Months Ended		0 Months Ended			1 Months Ended
	Sep. 30, 2014	Dec. 31, 2013	Oct. 06, 2014	Oct. 02, 2014	Oct. 02, 2014	Oct. 28, 2014
			Subsequent event	Subsequent event	Subsequent event	Subsequent event
				Baxter Healthcare Organization	Baxter Healthcare Organization	Baxter Healthcare Organization
Subsequent Events	'	'	'	'	'	'
Proceeds from Warrant Exercises	($429,750)	'	$8,000,000	'	'	'
Warrants exercised (in shares)	838,071	983,071	838,071	'	'	'
Warrants exercise price (in dollars per share)	'	'	$9.55	'	'	'
Common stock, shares issued (in shares)	41,015,392	40,110,661	838,071	'	1,316,944	'
Proceeds from issuance of private placement	'	'	'	15,000,000	'	'
Shares issued, price (in dollars per share)	'	'	'	'	$11.39	'
Shares issued, price above market close (in dollars per share)	'	'	'	'	$2.21	'
Agreement prohibiting transfer shares period, minimum	'	'	'	'	'	'1 year
Agreement prohibiting short sell shares period, minimum	'	'	'	'	'	'3 years
Agreement period before standstill provisions are effective	'	'	'	'	'	'1 year
Agreement standstill provisions ownership percent, maximum	'	'	'	'	'	4.90%
Distribution agreement term	'	'	'	'	'10 years	'
Upfront fee	'	'	'	'	20,000,000	'
Agreement termination notice period	'	'	'	'	'270 days	'
Agreement termination significant price increase notice period	'	'	'	'	'45 days	'
Agreement termination limited noncompete period	'	'	'	'	'2 years	'
Agreement Refund Trigger Event repayment percent first criteria	'	'	'	'	50.00%	'
Agreement Refund Trigger Event repayment percent second criteria	'	'	'	'	33.00%	'
Agreement Refund Trigger Event repayment percent third criteria	'	'	'	'	25.00%	'
Agreement property infringement repayment amount first criteria	'	'	'	'	10,000,000	'
Agreement property infringement repayment amount second criteria	'	'	'	'	6,600,000	'
Agreement prepayment secured long-term indebtedness period	'	'	'	'	'180 days	'
Facility Fee	'	'	'	'	10,000,000	'
Facility Fee reduction period	'	'	'	'	'12 months	'
Agreement extension period	'	'	'	'	'5 years	'
Agreement extension period two	'	'	'	'	'5 years	'
Extension fee	'	'	'	'	$7,500,000	'