ROCKWELL MEDICAL, INC. - Quarter Report: 2009 March (Form 10-Q)
Table of Contents
United States
SECURITIES AND EXCHANGE COMMISSION
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.
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
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year,
if changed since last report)
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 issuers 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.
Index to Form 10-Q
Index to Form 10-Q
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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
customers 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. Managements 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 Companys 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 Commissions 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 Companys 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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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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