Rockwell Medical (RMTI) 10-Q 7 May 15 2015 Q1 Quarterly report Financial data

Document_and_Entity_Informatio

Document and Entity Information	3 Months Ended
	Mar. 31, 2015	Apr. 30, 2015
Document and Entity Information
Entity Registrant Name	ROCKWELL MEDICAL, INC.
Entity Central Index Key	1041024
Document Type	10-Q
Document Period End Date	31-Mar-15
Amendment Flag	FALSE
Current Fiscal Year End Date	-19
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		50,269,383
Document Fiscal Year Focus	2015
Document Fiscal Period Focus	Q1

CONSOLIDATED_BALANCE_SHEETS

CONSOLIDATED BALANCE SHEETS (USD $)	Mar. 31, 2015	Dec. 31, 2014
ASSETS
Cash and Cash Equivalents	$63,332,646	$65,800,451
Investments Available for Sale	19,997,509	19,927,310
Accounts Receivable, net of a reserve of $53,000 in 2015 and $52,000 in 2014	4,665,831	4,472,002
Inventory	5,196,006	3,920,185
Other Current Assets	813,503	587,201
Total Current Assets	94,005,495	94,707,149
Property and Equipment, net	1,401,292	1,496,912
Intangible Assets	290,929	332,686
Goodwill	920,745	920,745
Other Non-current Assets	542,223	542,224
Total Assets	97,160,684	97,999,716
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts Payable	5,137,855	5,294,515
Accrued Liabilities	4,863,079	4,325,997
Customer Deposits	338,792	183,890
Total Current Liabilities	10,339,726	9,804,402
Deferred License Revenue	18,999,293	19,492,520
Shareholders' Equity:
Common Shares, no par value, 50,269,383 and 50,284,007 shares issued and outstanding	251,766,056	249,018,189
Accumulated Deficit	-183,816,920	-180,117,726
Accumulated Other Comprehensive Income (Loss)	-127,471	-197,669
Total Shareholders' Equity	67,821,665	68,702,794
Total Liabilities And Shareholders' Equity	$97,160,684	$97,999,716

CONSOLIDATED_BALANCE_SHEETS_Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)	Mar. 31, 2015	Dec. 31, 2014
CONSOLIDATED BALANCE SHEETS
Allowance for reserve, accounts receivable (in dollars)	$53,000	$52,000
Common Shares, par value (in dollars per share)	$0	$0
Common Shares, shares issued	50,269,383	50,284,007
Common Shares, shares outstanding	50,269,383	50,284,007

CONSOLIDATED_INCOME_STATEMENTS

CONSOLIDATED INCOME STATEMENTS (USD $)	3 Months Ended
	Mar. 31, 2015	Mar. 31, 2014
CONSOLIDATED INCOME STATEMENTS
Sales	$13,883,961	$12,963,652
Cost of Sales	11,571,618	11,283,694
Gross Profit	2,312,343	1,679,958
Selling, General and Administrative	5,325,761	4,090,199
Research and Product Development	799,591	4,615,197
Operating Income (Loss)	-3,813,009	-7,025,438
Interest and Investment Income, net	113,815	74,215
Interest Expense		854,303
Income (Loss) Before Income Taxes	-3,699,194	-7,805,526
Net Income (Loss)	($3,699,194)	($7,805,526)
Basic Earnings (Loss) per Share (in dollars per share)	($0.07)	($0.20)
Diluted Earnings (Loss) per Share (in dollars per share)	($0.07)	($0.20)

CONSOLIDATED_STATEMENTS_OF_COM

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (USD $)	3 Months Ended
	Mar. 31, 2015	Mar. 31, 2014
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Net Income (Loss)	($3,699,194)	($7,805,526)
Unrealized Gain on Available-for-Sale Investments	70,198	33,860
Comprehensive Income (Loss)	($3,628,996)	($7,771,666)

CONSOLIDATED_STATEMENTS_OF_CHA

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (USD $)	COMMON SHARES	ACCUMULATED DEFICIT	ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS)	Total
Balance at Dec. 31, 2014	$249,018,189	($180,117,726)	($197,669)	$68,702,794
Balance (in shares) at Dec. 31, 2014	50,284,007			50,284,007
Increase (Decrease) in Shareholders' Equity
Net (Loss)		-3,699,194		-3,699,194
Unrealized Gain (Loss) on Available-for-Sale Securities			70,198	70,198
Issuance of Common Shares	918,884			918,884
Issuance of Common Shares (in shares)	125,166
Stock Option Based Expense	1,215,369			1,215,369
Restricted Stock Amortization	2,077,215			2,077,215
Restricted Stock Tendered in Satisfaction of Tax Liabilities	-1,463,601			-1,463,601
Restricted Stock Tendered in Satisfaction of Tax Liabilities (in shares)	-139,790			-139,790
Balance at Mar. 31, 2015	$251,766,056	($183,816,920)	($127,471)	$67,821,665
Balance (in shares) at Mar. 31, 2015	50,269,383			50,269,383

CONSOLIDATED_STATEMENTS_OF_CAS

CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)	3 Months Ended
	Mar. 31, 2015	Mar. 31, 2014
Cash Flows From Operating Activities:
Net (Loss)	($3,699,194)	($7,805,526)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
Depreciation and Amortization	207,858	257,761
Share Based Compensation- Employees	3,292,584	2,174,212
Restricted Stock Tendered in Satisfaction of Tax Liabilities	-1,463,601
Amortization of Debt Issuance Costs		113,529
Non-cash Interest Expense		112,529
Loss on Disposal of Assets	2,424	1,662
Changes in Assets and Liabilities:
(Increase) Decrease in Accounts Receivable	-193,829	477,866
(Increase) in Inventory	-1,275,821	-110,180
(Increase) in Other Assets	-226,301	-243,936
(Decrease) in Accounts Payable	-156,661	-3,552,886
Increase (Decrease) in Other Liabilities	691,984	-1,790,208
Deferred License Revenue	-493,227
Changes in Assets and Liabilities	-1,653,855	-5,219,344
Cash (Used In) Operating Activities	-3,313,784	-10,365,177
Cash Flows From Investing Activities:
Purchase of Investments Available for Sale		-2,000,000
Purchase of Equipment	-77,705	-329,882
Proceeds on Sale of Assets	4,800
Cash (Used In) Investing Activities	-72,905	-2,329,882
Cash Flows From Financing Activities:
Proceeds from the Issuance of Common Shares and Purchase Warrants	918,884	1,474,725
Cash Provided By Financing Activities	918,884	1,474,725
Increase (Decrease) In Cash	-2,467,805	-11,220,334
Cash At Beginning Of Period	65,800,451	11,881,451
Cash At End Of Period	63,332,646	661,117
Supplemental Cash Flow disclosure
Interest Paid		$628,244

Description_of_Business

Description of Business	3 Months Ended
	Mar. 31, 2015
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 and chronic kidney disease with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.  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 are currently developing unique, proprietary renal drug therapies. These novel 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 obtained global licenses for certain dialysis related drugs which we are developing and planning to market.
	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”.  We supply our products to medical service providers who treat patients with kidney disease.  Our products are used to cleanse patients’ blood and replace nutrients lost during the kidney dialysis process.  We primarily sell our products in the United States.
	We are regulated by the Federal Food and Drug Administration (“FDA”) under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies.  We obtained FDA approval of TrifericTM our branded dialysis iron maintenance therapy drug, in January 2015.  We have also received 510(k) approval from the FDA to market hemodialysis solutions and powders and, to sell our Dri-Sate Dry Acid Concentrate product line and our Dri-Sate Mixer.

Summary_of_Significant_Account

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2015
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, 2014 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 months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2014 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 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.
	The initial payment received from our long-term Distribution Agreement has been deferred and classified as deferred license revenue.   Deferred license revenue is being recognized based on the proportion of product shipments to Baxter Healthcare Corporation (“Baxter”) in each period to total expected sales volume for the term of the agreement.
	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 $19,997,509 as of March 31, 2015.  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 $23,839 and gross unrealized losses were $151,310 as of March 31, 2015.  There were no realized gains or losses in the first quarter of 2015.
	The Company has evaluated the near term interest rate environment and 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 March 31, 2015.
	Research and Product Development
	We recognize research and product development expenses as incurred.  We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including our recently FDA approved iron delivery maintenance drug,  Triferic™, aggregating approximately $0.8 million and $4.6 million for the three months ended March 31, 2015 and 2014, respectively.
	We submitted our NDA for TrifericTM to the FDA on March 24, 2014 and paid the standard new drug application fee under the Prescription Drug User Fee Act of $2,169,100.  The Company sought qualification as a small business in order to waive the fee, however, the application to obtain the waiver was denied by the Small Business Administration.  The Company subsequently appealed that determination and on June 9, 2014, the waiver was granted.  The NDA fee was recognized as an expense in the first quarter of 2014, and that expense was reversed in the second quarter of 2014 upon notification of the successful appeal.
	Share Based Compensation
	We measure the cost of employee services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards in accordance with ASC 718-10, Compensation — Stock Compensation. The cost of equity based compensation is recognized as compensation expense over the vesting period of the awards.
	We estimate the fair value of compensation involving stock options utilizing the Black-Scholes option pricing model.  This model requires the input of several factors such as the expected option term, expected volatility of our stock price over the expected option term, and an expected forfeiture rate, and is subject to various assumptions.  We believe the valuation methodology is appropriate for estimating the fair value of stock options we grant to employees and directors which are subject to ASC 718-10 requirements.  These amounts are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants.
	The Company’s Long Term Incentive Plan permits grantees to tender shares to the Company in satisfaction of liabilities related to the exercise of equity awards, including the exercise price of options and tax liabilities related to equity awards.  During the first quarter of 2015, 139,790 shares were tendered to the Company in satisfaction of $1,463,601 of such liabilities.
	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 Ended
		March 31,
		2015	2014
	Basic Weighted Average Shares Outstanding	49,667,434	39,812,820
	Effect of Dilutive Securities	—	—
	Diluted Weighted Average Shares Outstanding	49,667,434	39,812,820

INVENTORY

INVENTORY	3 Months Ended
	Mar. 31, 2015
Inventory
Inventory
	3.  Inventory
	Components of inventory as of March 31, 2015 and December 31, 2014 are as follows:
		March 31,		December 31,
		2015		2014
	Raw Materials	$	3,460,108	$	2,197,143
	Work in Process	212,496		197,106
	Finished Goods	1,523,402		1,525,936
	Total	$	5,196,006	$	3,920,185

DISTRIBUTION_AGREEMENT

DISTRIBUTION AGREEMENT	3 Months Ended
	Mar. 31, 2015
Distribution Agreement.
Distribution Agreement
	4.   Distribution Agreement
	As of October 2, 2014, we entered into a Distribution Agreement with Baxter, pursuant to which Baxter became the Company’s exclusive agent for sales, marketing and distribution activities for the Company’s hemodialysis concentrate and ancillary products in the United States and various foreign countries for an initial term of 10 years.  The Distribution Agreement does not include any of the Company’s drug products.  The Company will retain sales, marketing and distribution rights for its hemodialysis concentrate products in specified foreign 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.
	Pursuant to the Distribution Agreement, Baxter paid the Company $20 million in cash in early October (the “Upfront Fee”).  The Upfront Fee has been deferred and will be recognized as revenue based on the proportion of product shipments to Baxter in each period to total expected sales volume over the term of the Distribution Agreement. The Company recognized revenue associated with the Upfront Fee totaling $493,227 for the quarter ended March 31, 2015.
	Under the Distribution Agreement, Baxter will purchase products from the Company at established gross margin-based prices per unit, adjusted each year during the term.  The Company will continue to manage customer service, transportation and certain other functions for its current customers on Baxter’s behalf through at least December 31, 2017, in exchange for which Baxter will pay the Company an amount equal to the Company’s related costs to provide such functions plus a slight mark-up.
	The Distribution Agreement also requires Baxter to meet minimum annual gallon-equivalent purchase levels, subject to a cure period and certain other relief, in order to maintain its exclusive distribution rights.  The minimum purchase levels increase each year over the term of the Distribution Agreement.  Orders in any contract year that exceed the minimum will be carried forward and applied to future years’ minimum requirements. The Distribution Agreement also contains provisions governing the operating relationship between the parties, 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 in the United States any product covered by the Distribution Agreement due to a claim of intellectual property infringement or misappropriation relating to such product prior to the end of 2018, Baxter would be entitled to a refund of up to $10 million, or $6.6 million if the termination occurs in 2019. In no event would Baxter be entitled to more than one refund payment.
	The Distribution Agreement also required 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 $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 later be extended an additional five years at Baxter’s option at no additional cost.

Summary_of_Significant_Account1

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2015
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, 2014 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 months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2014 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 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.
	The initial payment received from our long-term Distribution Agreement has been deferred and classified as deferred license revenue.   Deferred license revenue is being recognized based on the proportion of product shipments to Baxter Healthcare Corporation (“Baxter”) in each period to total expected sales volume for the term of the agreement.
	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 $19,997,509 as of March 31, 2015.  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 $23,839 and gross unrealized losses were $151,310 as of March 31, 2015.  There were no realized gains or losses in the first quarter of 2015.
	The Company has evaluated the near term interest rate environment and 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 March 31, 2015.
Research and Product Development
	Research and Product Development
	We recognize research and product development expenses as incurred.  We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including our recently FDA approved iron delivery maintenance drug,  Triferic™, aggregating approximately $0.8 million and $4.6 million for the three months ended March 31, 2015 and 2014, respectively.
	We submitted our NDA for TrifericTM to the FDA on March 24, 2014 and paid the standard new drug application fee under the Prescription Drug User Fee Act of $2,169,100.  The Company sought qualification as a small business in order to waive the fee, however, the application to obtain the waiver was denied by the Small Business Administration.  The Company subsequently appealed that determination and on June 9, 2014, the waiver was granted.  The NDA fee was recognized as an expense in the first quarter of 2014, and that expense was reversed in the second quarter of 2014 upon notification of the successful appeal.
Share Based Compensation
	Share Based Compensation
	We measure the cost of employee services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards in accordance with ASC 718-10, Compensation — Stock Compensation. The cost of equity based compensation is recognized as compensation expense over the vesting period of the awards.
	We estimate the fair value of compensation involving stock options utilizing the Black-Scholes option pricing model.  This model requires the input of several factors such as the expected option term, expected volatility of our stock price over the expected option term, and an expected forfeiture rate, and is subject to various assumptions.  We believe the valuation methodology is appropriate for estimating the fair value of stock options we grant to employees and directors which are subject to ASC 718-10 requirements.  These amounts are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants.
	The Company’s Long Term Incentive Plan permits grantees to tender shares to the Company in satisfaction of liabilities related to the exercise of equity awards, including the exercise price of options and tax liabilities related to equity awards.  During the first quarter of 2015, 139,790 shares were tendered to the Company in satisfaction of $1,463,601 of such liabilities.
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 Ended
		March 31,
		2015	2014
	Basic Weighted Average Shares Outstanding	49,667,434	39,812,820
	Effect of Dilutive Securities	—	—
	Diluted Weighted Average Shares Outstanding	49,667,434	39,812,820

Summary_of_Significant_Account2

Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2015
Summary of Significant Accounting Policies
Schedule of weighted average shares outstanding used in calculating basic and diluted earnings per share
		Three Months Ended
		March 31,
		2015	2014
	Basic Weighted Average Shares Outstanding	49,667,434	39,812,820
	Effect of Dilutive Securities	—	—
	Diluted Weighted Average Shares Outstanding	49,667,434	39,812,820

Inventory_Tables

Inventory (Tables)	3 Months Ended
	Mar. 31, 2015
Inventory
Schedule components of inventory
		March 31,		December 31,
		2015		2014
	Raw Materials	$	3,460,108	$	2,197,143
	Work in Process	212,496		197,106
	Finished Goods	1,523,402		1,525,936
	Total	$	5,196,006	$	3,920,185

Summary_of_Significant_Account3

Summary of Significant Accounting Policies (Details) (USD $)	3 Months Ended		0 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 24, 2014	Dec. 31, 2014
Investments Available for Sale
Fair value of investments	$19,997,509			$19,927,310
Gross unrealized gains	23,839
Gross unrealized losses	151,310
Realized gains or losses	0
Research and Product Development
Product development and research costs	799,591	4,615,197
Patents
Research and Product Development
NDA review fee			$2,169,100

Summary_of_Significant_Account4

Summary of Significant Accounting Policies (Details 2) (USD $)	3 Months Ended
	Mar. 31, 2015	Mar. 31, 2014
Share-based Compensation.
Restricted Stock Tendered in Satisfaction of Tax Liabilities	$1,463,601
Restricted Stock Tendered in Satisfaction of Tax Liabilities (in shares)	139,790
Weighted average shares outstanding used in calculating basic and diluted earnings per share
Basic Weighted Average Shares Outstanding	49,667,434	39,812,820
Diluted Weighted Average Shares Outstanding	49,667,434	39,812,820

Inventory_Details

Inventory (Details) (USD $)	Mar. 31, 2015	Dec. 31, 2014
Inventory
Raw Materials	$3,460,108	$2,197,143
Work in Process	212,496	197,106
Finished Goods	1,523,402	1,525,936
Total	$5,196,006	$3,920,185

DISTRIBUTION_AGREEMENT_Details

DISTRIBUTION AGREEMENT (Details) (USD $)	3 Months Ended	0 Months Ended
	Mar. 31, 2015	Oct. 02, 2014
Recognized Distribution Agreement Income	($493,227)
Baxter Healthcare Organization
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