FORM 10-Q
Table of Contents

 
 
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
 
(Mark One)
     
þ   Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended March 31, 2009
or
     
o   Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from                      to                     
Commission File Number: 000-23661
ROCKWELL MEDICAL TECHNOLOGIES, INC.
 
(Exact name of registrant as specified in its charter)
     
Michigan   38-3317208
     
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)
     
30142 Wixom Road, Wixom, Michigan   48393
     
(Address of principal executive offices)   (Zip Code)
(248) 960-9009
 
(Registrant’s telephone number, including area code)
 
(Former name, former address and former fiscal year,
if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
o Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ  Non-accelerated filer o
(Do not check if a smaller reporting company)
Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
o Yes þ No
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
     
Class   Outstanding as of April 30, 2009
Common Stock, no par value   14,132,712 shares
 
 

 


 

Rockwell Medical Technologies, Inc.
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 EX-31.1
 EX-31.2
 EX-32.1

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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of March 31, 2009 and December 31, 2008
                 
    March 31, 2009     December 31,  
    (Unaudited)     2008  
ASSETS
               
Cash and Cash Equivalents
  $ 3,353,468     $ 5,596,645  
Accounts Receivable, net of a reserve of $83,000 in 2009 and $97,000 in 2008
    4,869,201       5,229,656  
Inventory
    2,815,829       3,161,625  
Other Current Assets
    484,898       440,765  
 
           
Total Current Assets
    11,523,396       14,428,691  
 
               
Property and Equipment, net
    3,263,906       3,249,003  
Intangible Assets
    235,305       240,656  
Goodwill
    920,745       920,745  
Other Non-current Assets
    123,387       120,887  
 
           
Total Assets
  $ 16,066,739     $ 18,959,982  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
 
               
Notes Payable & Capitalized Lease Obligations
  $ 139,202     $ 176,850  
Accounts Payable
    3,834,491       5,210,972  
Accrued Liabilities
    1,240,579       1,464,828  
Customer Deposits
    208,751       245,186  
 
           
Total Current Liabilities
    5,423,023       7,097,836  
 
               
Long Term Notes Payable & Capitalized Lease Obligations
    28,976       41,203  
 
               
Shareholders’ Equity:
               
Common Shares, no par value, 14,132,712 and 14,104,690 shares issued and outstanding
    35,172,916       34,799,093  
Common Share Purchase Warrants, 2,134,169 and 2,114,169 warrants issued and outstanding
    3,513,815       3,378,398  
Accumulated Deficit
    (28,071,991 )     (26,356,548 )
 
           
Total Shareholders’ Equity
    10,614,740       11,820,943  
 
           
 
               
Total Liabilities And Shareholders’ Equity
  $ 16,066,739     $ 18,959,982  
 
           
The accompanying notes are an integral part of the consolidated financial statements.

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ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three months ended March 31, 2009 and March 31, 2008
(Unaudited)
                 
    Three Months     Three Months  
    Ended     Ended  
    March 31, 2009     March 31, 2008  
Sales
  $ 12,796,772     $ 12,412,037  
Cost of Sales
    11,603,825       11,694,736  
 
           
Gross Profit
    1,192,947       717,301  
Selling, General and Administrative
    1,560,815       1,289,752  
Research and Product Development
    1,338,310       782,713  
 
           
Operating (Loss)
    (1,706,178 )     (1,355,164 )
Interest Expense (Income), net
    9,265       (144,991 )
 
           
Net (Loss)
  $ (1,715,443 )   $ (1,210,173 )
 
           
 
               
Basic Earnings (Loss) per Share
    ($.12 )     ($.09 )
 
               
Diluted Earnings (Loss) per Share
    ( $.12 )     ($.09 )
The accompanying notes are an integral part of the consolidated financial statements.

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ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2009 and March 31, 2008
(Unaudited)
                 
    2009     2008  
 
               
Cash Flows From Operating Activities:
               
Net (Loss)
  $ (1,715,443 )   $ (1,210,173 )
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
               
Depreciation and Amortization
    227,373       199,260  
Loss (Gain) on Disposal of Assets
    (5,121 )     431  
Share Based Compensation — Non-employee Warrants
    135,417       91,758  
Share Based Compensation — Employees
    373,823       242,981  
 
               
Changes in Assets and Liabilities:
               
Decrease in Accounts Receivable
    360,455       542,188  
Decrease (Increase) in Inventory
    345,796       (113,102 )
(Increase) in Other Assets
    (46,633 )     (77,288 )
Increase (Decrease) in Accounts Payable
    (1,376,481 )     435,359  
(Decrease) in Other Liabilities
    (260,684 )     (233,388 )
 
           
Changes in Assets and Liabilities
    (977,547 )     553,769  
 
           
Cash (Used) In Operating Activities
    (1,961,498 )     (121,974 )
 
               
Cash Flows From Investing Activities:
               
Purchase of Equipment
    (234,563 )     (304,032 )
Proceeds on Sale of Assets
    5,121        
Purchase of Intangible Assets
    (2,362 )      
 
           
Cash (Used ) In Investing Activities
    (231,804 )     (304,032 )
 
               
Cash Flows From Financing Activities:
               
Issuance of Common Shares and Purchase Warrants
          27,491  
Payments on Notes Payable
    (49,875 )     (57,360 )
 
           
Cash (Used) By Financing Activities
    (49,875 )     (29,869 )
 
               
(Decrease) In Cash
    (2,243,177 )     (455,875 )
Cash At Beginning Of Period
    5,596,645       11,097,092  
 
           
Cash At End Of Period
  $ 3,353,468     $ 10,641,217  
 
           
Supplemental Cash Flow disclosure
                 
    2009   2008
Interest Paid
  $ 9,265     $ 17,438  
The accompanying notes are an integral part of the consolidated financial statements

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Rockwell Medical Technologies, Inc. and Subsidiary
Notes to Consolidated Financial Statements
1. Description of Business
     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. References in these Notes to “the Company,” “we,” “our” and “us” are references to Rockwell Medical Technologies, Inc. and its subsidiaries.
     We are regulated by the Federal Food and Drug Administration, or “FDA,” under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies. We have 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. We have also obtained global licenses for certain dialysis related drugs which we are developing and for which we are seeking FDA approval to market. We plan to devote substantial resources to the development, clinical testing and FDA approval of our lead drug candidate.
2. Summary of Significant Accounting Policies
Basis of Presentation
     Our consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiary, Rockwell Transportation, Inc. All intercompany balances and transactions have been eliminated. 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, 2008 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 which 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 month period ended March 31, 2009 is not necessarily indicative of the results to be expected for the year ending December 31, 2009. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2008 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2008 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 GAAP. 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

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our terms of sale. At March 31, 2009 and December 31, 2008, we had customer deposits of $208,751 and $245,186, respectively.
Research and Product Development
     We recognize research and product development costs as expenses are incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including iron supplemented dialysate (“SFP”), aggregating approximately $1.3 million and $0.8 million in the first three months of 2009 and 2008, respectively. We are conducting human clinical trials on SFP and we recognize the costs of these clinical trials as the costs are incurred and services are performed over the duration of the trials.
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. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were:
                 
    Three months ended March 31,
    2009   2008
Basic Weighted Average Shares Outstanding
    13,979,325       13,817,433  
Effect of Dilutive Securities
           
 
               
Diluted Weighted Average Shares Outstanding
    13,979,325       13,817,433  
 
               
Reclassifications
The Company has reclassified certain expenses from Selling, General and Administrative Expense to Cost of Sales in the 2008 consolidated income statement to conform with the current year presentation. The impact of the change was not material.
3. Inventory
     Components of inventory as of March 31, 2009 and December 31, 2008 are as follows:
                 
    March 31,     December 31,  
    2009     2008  
Raw Materials
  $ 919,256     $ 1,316,875  
Work in Process
    312,737       291,937  
Finished Goods
    1,583,836       1,552,813  
 
           
Total
  $ 2,815,829     $ 3,161,625  
 
           

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
     The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements and the Notes thereto included elsewhere in this report. References in this report to “we,” “our” and “us” are references to Rockwell Medical Technologies, Inc. and its subsidiaries.
Forward-Looking Statements
     We make forward-looking statements in this report and may make such statements in future filings with the Securities and Exchange Commission, or SEC. We may also make forward-looking statements in our press releases or other public or shareholder communications. Our forward-looking statements are subject to risks and uncertainties and include information about our expectations and possible or assumed future results of our operations. When we use words such as “may,” might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “projected,” “intend,” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. Our forward looking statements also include, without limitation, statements about our competitors, statements regarding the timing and costs of obtaining FDA approval of our new SFP product and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.
     We claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 for all of our forward-looking statements. While we believe that our forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this report or, if made elsewhere, as of the date made. Because these forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors that might cause such a difference include, without limitation, the risks and uncertainties discussed below and elsewhere in this report, and from time to time in our other reports filed with the Securities and Exchange Commission, including, without limitation, in “Item 1A — Risk Factors” in our Form 10-K for the year ended December 31, 2008.
  The dialysis provider market is highly concentrated in national and regional dialysis chains that account for the majority of our domestic revenue. Our business is substantially dependent on one of our customers that accounts for a significant portion of our sales. The loss of this customer would have a material adverse effect on our results of operations and cash flows.
 
  We operate in a very competitive market against substantially larger competitors with greater resources.
 
  Our new drug product requires FDA approval and expensive clinical trials before it can be marketed.
 
  Even if our new drug product is approved by the FDA it may not be successfully marketed.
 
  We may not be successful in improving our gross profit margins and our business may remain unprofitable.
 
  We depend on government funding of healthcare.
 
  We may not have sufficient cash to fund future growth or SFP development.
 
  Orders from our international distributors may not result in recurring revenue.
 
  We depend on key personnel.
 
  Our business is highly regulated.

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  We depend on contract research organizations and consultants to manage and conduct our clinical trials and if they fail to follow our protocol or meet FDA regulatory requirements our clinical trial data and results could be compromised causing us to delay our development plans or have to do more testing than planned.
 
  Foreign approvals to market our new drug products may be difficult to obtain.
 
  Health care reform could adversely affect our business.
 
  We may not have sufficient products liability insurance.
 
  Our Board of Directors is subject to potential deadlock.
 
  Shares eligible for future sale may affect the market price of our common shares.
 
  The market price of our securities may be volatile.
 
  Voting control and anti-takeover provisions reduce the likelihood that you will receive a takeover premium.
 
  We do not anticipate paying dividends in the foreseeable future.
     Other factors not currently anticipated may also materially and adversely affect our results of operations, cash flows and financial position. There can be no assurance that future results will meet expectations. We do not undertake, and expressly disclaim, any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as may be required by applicable law.
Overview and Recent Developments
     We operate in a single business segment, the manufacture and distribution of hemodialysis concentrates, dialysis kits and ancillary products used in the kidney dialysis process. We have gained domestic market share each year since our inception in 1996. Our sales grew approximately 80% over the two years ending December 31, 2008. Our domestic sales in the first quarter of 2009 increased approximately 5.5% compared to the first quarter of last year. Our strategy is to continue to develop and expand our dialysis products business while at the same time developing new products, including pharmaceutical products for the renal market.
     As we experienced substantial sales growth over the last two years, we also experienced unprecedented increases in the costs for chemicals, packaging materials and fuel. Although we raised our prices over this period, the price increases did not keep pace with the cost increases. As a result, our gross profit and gross profit margins decreased significantly.
     We took actions in the last quarter of 2008 that improved our margins in the first quarter of 2009, including raising prices, changing vendors, changing our product mix and reducing operating costs. Softening of commodity prices also contributed to the recovery of our losses in gross profit margin over the last two years.
     We plan to continue to increase prices to improve our gross profit. However, it may be difficult to raise prices adequately due to price competition. We typically enter into supply contracts that have a term similar to our contracts with customers to mitigate our exposure to raw material and other cost increases.
     While the majority of our business is with domestic clinics who order routinely, certain major distributors of our products internationally have not ordered consistently, resulting in variation in our sales from period to period. We anticipate that we will realize substantial orders from time to time from our largest international distributors but we expect the size and frequency of these orders to fluctuate from period to period. These orders may increase in future periods or may not recur at all.

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     We are continuing the FDA approval process for our iron supplemented dialysate product, SFP. We believe our SFP product, which has a unique method of action and other substantive benefits compared to current treatment options, has the potential to compete successfully in the iron maintenance therapy market. However, the cost to obtain regulatory approval for a drug in the United States is expensive and can take several years. We currently expect to spend approximately $4 million in 2009 to complete our Phase IIb clinical trials and other related development costs. Once we complete the Phase II clinical study, we will seek FDA approval to commence a Phase III clinical trial. We anticipate that costs to complete clinical trials and to obtain FDA approval to market SFP from 2010 until such approval may total approximately $15 million depending on the duration and size of the studies required.
Results of Operations for the Three Months Ended March 31, 2009 and March 31, 2008
Sales
     Sales in the first quarter of 2009 were $12.8 million, an increase of $0.4 million or 3.1% over the first quarter of 2008. Our domestic sales increased 5.5% while our international sales decreased by 16.1%. With respect to our domestic business, our overall treatment volume remained consistent with the first quarter of 2008 although our product mix shifted significantly toward our Dri-Sate dry acid concentrate product lines as customers sought cost effective alternatives to higher pricing on liquid products.
     International sales, which represented 9% of our total sales in the first quarter of 2009, decreased due to a reduction of $0.75 million in orders from distributors for one market compared to the first quarter of 2008 while all other international sales in the first quarter of 2009 increased by $0.5 million compared to the first quarter of 2008.
Gross Profit
     Gross profit in the first quarter of 2009 was $1.2 million compared to $0.7 million in the first quarter of 2008. Gross profit margins increased to 9.3% from 5.8% in the first quarter of 2008. The increase in gross profit was due to reductions in material costs, fuel costs and operating expenses coupled with price increases. In early 2009, we entered into new supply contracts and made certain vendor changes, and also benefitted from reductions in costs for certain chemicals and fuel, which were the primary reasons for the improvement in gross profit margins in the first quarter of 2009. We reclassified certain quality assurance and operations management expenses totaling $140,000 to cost of sales from selling, general and administrative expense for the first quarter of 2008 to maintain comparability of prior year results with the current year presentation.
Selling, General and Administrative Expense
     Selling, general and administrative expense, or “SG&A,” during the first quarter of 2009 was $1.6 million compared to $1.3 million in the first quarter of 2008, an increase of $0.3 million or 21.0%. Non-cash charges for equity compensation were $0.5 million in the first quarter of 2009 compared to $0.3 million in the first quarter of 2008. Other cost increases included additional information technology costs and personnel expenses in support of our business growth over the last two years.
Research and Development
     Research and development costs were $1.3 million in the first quarter of 2009 compared to $0.8 million in the first quarter of 2008. Spending in both periods was primarily devoted to development and approval of SFP, our proprietary anemia drug used to treat iron deficiency in dialysis patients. We are conducting a Phase IIb clinical trial and we anticipate spending approximately $4 million in 2009 for SFP related development spending.

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Interest Income, Net
     Our net interest expense was $9,000 in the first quarter of 2009 compared to net interest income of $145,000 in the first quarter of 2008. The decrease in interest income was due to less funds available for investment and substantially lower market interest rates compared to the first quarter of 2008. Due to financial market turmoil in late 2008, the Company’s financial institution terminated its short term investment program for its corporate customers and did not offer a suitable replacement. The Company was not able to identify a short term investment program with an acceptable risk to return profile and elected not to expose its cash resources to investment risk during the first quarter of 2009.
Liquidity and Capital Resources
     We have two major areas of strategic focus in our business: development of our dialysis products business and expansion of our product offering to include drugs and vitamins administered to dialysis patients. We expect to expend substantial amounts in support of our clinical development plan and regulatory approval of SFP and its extensions. Each of these initiatives will require investments of substantial amounts of capital.
     In November 2007, we raised approximately $12.8 million in equity capital (net of related expenses) primarily for the purpose of funding the clinical development and FDA approval of SFP. We expect to spend approximately $4 million on SFP development and testing in 2009.
     Upon completion of our Phase IIb clinical trial we will seek FDA approval to conduct Phase III clinical trials for SFP. We anticipate that the cost to fund our Phase III clinical trials and to obtain FDA approval to market SFP will cost as much as $15 million from 2010 until approval. We will evaluate various alternative sources of funding in order to raise additional capital or enter into development arrangements with an international development partner in order to fully execute our strategic plan. In our efforts to obtain additional capital resources, we will evaluate both debt and equity financing as potential sources of funds. We will also evaluate alternative sources of business development funding, licensing agreements with international marketing partners, sub-licensing of certain products for certain markets as well as other potential funding sources.
     Our cash resources include cash generated from our business operations and the remaining proceeds from our November 2007 equity offering. Our current assets exceed our current liabilities by over $6.1 million as of March 31, 2009 and included $3.4 million in cash. In the first quarter of 2009, we used $2.2 million in cash, including $2.0 million in operating activities and $0.2 million for capital expenditures. Our cash used in operations was primarily used to fund our research and development expenditures of $1.3 million, and the remainder was used to fund working capital requirements in our core business operations, including a reduction in accounts payable of $1.4 million partly attributable to a $0.4 million reduction in raw material inventory. Non-cash charges against operating results were $0.8 million in the first quarter of 2009.
     We expect to generate positive cash flow from operations during the remainder of 2009, excluding our research and development expenses. We based our cash flow projections on the expected effects of the reductions in material costs that commenced in January 2009 from our new supply contracts, reduced diesel fuel expenses and other actions we have taken to reduce certain other operating expenses, as well as the price increases we have implemented.
     We believe our current cash resources are sufficient to fund the completion of our Phase IIb clinical trial and prepare for our Phase III clinical trial as well as fund our ordinary course operating cash requirements in 2009. However, if we use more cash than anticipated for SFP development or to fund business operations, or if the assumptions underlying our cash flow projections for 2009 prove to be incorrect, we would need to obtain additional cash such as through equity financing, debt financing of capital expenditures or a line of credit to supplement our working capital requirements in 2009 or 2010. Should we not be able to obtain additional financing or enter into development or licensing arrangements, we may be forced to alter our strategy, delay spending on development initiatives or take other actions to conserve cash resources.

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Item 3. Quantitative and Qualitative Disclosures about Market Risk
Foreign Currency Exchange Rate Risk
     Our international business is conducted in U.S. dollars. It has not been our practice to hedge the risk of appreciation of the U.S. dollar against the predominant currencies of our trading partners. We have no significant foreign currency exposure to foreign supplied materials, and an immediate 10% strengthening or weakening of the U.S. dollar would not have a material impact on our shareholders’ equity or net income.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
     Management is responsible for establishing and maintaining effective disclosure controls and procedures, as defined under Rule 13a-15 of the Securities Exchange Act of 1934, as amended, that are designed to ensure that material information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required financial disclosure. In designing and evaluating the disclosure controls and procedures, we recognized that a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
     As of the end of the period covered by this report, we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, including their evaluation of the status of the material weakness remediation noted below, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective, at the reasonable assurance level, as of the end of the period covered by this report.
Changes in Internal Control over Financial Reporting
     No changes were made to our internal control over financial reporting (as defined in Rule 13a-15 under the Exchange Act) during the fiscal quarter ended March 31, 2009 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except as described below.
     As discussed in the Company’s Annual Report on Form-10-K for the year ended December 31, 2008, there were two material weaknesses in internal control over financial reporting identified by management relating to (i) inadequate segregation of duties pertaining to access to information technology applications used in our business operations and (ii) inventory valuation and reporting procedures. These internal control deficiencies did not result in any material adjustments to the 2008 annual or interim consolidated financial statements.
     Beginning in the fourth quarter of 2008 and continuing in the first quarter of 2009, management implemented a number of changes to the access controls for information technology applications, including new access restrictions and improved monitoring of user access. Management also implemented additional inventory control, valuation and monitoring procedures. These changes included a complete review and update of all standard costs, monthly transaction sample testing for completeness and accuracy, ongoing inventory cycle counting procedures, and a periodic status review of all open jobs. As a result of these changes and review by management, management has concluded that the previously reported material weaknesses no longer exist as of March 31, 2009.

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PART II — OTHER INFORMATION
Item 1A. Risk Factors
     For information regarding risk factors affecting us, see “Risk Factors” in Item 1A of Part I of our 2008 Annual Report on Form 10-K. There have been no material changes to the risk factors described in such Form 10-K.
Item 6. Exhibits
     See Exhibit Index following signature page, which is incorporated herein by reference.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
    ROCKWELL MEDICAL TECHNOLOGIES, INC.
(Registrant)
 
Date: May 11, 2009    /s/ ROBERT L. CHIOINI  
    Robert L. Chioini 
    President and Chief Executive
Officer (principal executive officer) (duly authorized officer) 
 
     
Date: May 11, 2009    /s/ THOMAS E. KLEMA  
    Thomas E. Klema 
    Vice President and Chief Financial Officer
(principal financial officer and principal accounting officer) 

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Table of Contents

         
10-Q EXHIBIT INDEX
     
Exhibit No.   Description
 
   
31.1
  Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
31.2
  Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
32.1
  Certification pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(b) of the Securities Exchange Act of 1934

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EX-31.1
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a)
     I, Robert L. Chioini, certify that:
     1. I have reviewed this quarterly report on Form 10-Q of Rockwell Medical Technologies, Inc.;
     2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
     a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 11, 2009
         
     
/s/ Robert L. Chioini      
Robert L. Chioini     
President and Chief Executive Officer     

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EX-31.2
         
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a)
     I, Thomas E. Klema, certify that:
     1. I have reviewed this quarterly report on Form 10-Q of Rockwell Medical Technologies, Inc.;
     2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
     a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 11, 2009
         
     
/s/ Thomas E. Klema      
Thomas E. Klema     
Vice President and Chief Financial Officer     

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EX-32.1
         
EXHIBIT 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
AND CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
     In connection with the Quarterly Report of Rockwell Medical Technologies, Inc. (the “Company”) on Form 10-Q for the quarter ending March 31, 2009 as filed with the Securities and Exchange Commission on the date hereof (the “Periodic Report”), I, Robert L. Chioini, Chief Executive Officer of the Company and I, Thomas E. Klema, Chief Financial Officer of the Company, each certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
  1.   the Periodic Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
  2.   the information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
         
     
Dated: May 11, 2009  /s/ Robert L. Chioini    
  Robert L. Chioini   
  President and Chief Executive Officer   
 
     
Dated: May 11, 2009  /s/ Thomas E. Klema    
  Thomas E. Klema   
  Vice President and Chief Financial Officer   
 

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