e10vq
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2010
or
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o |
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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)
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Michigan
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38-3317208 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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30142 Wixom Road, Wixom, Michigan
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48393 |
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(Address of principal executive offices)
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(Zip Code) |
(248) 960-9009
(Registrants 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 (§ 232.405 of this chapter) 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.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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.
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Class
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Outstanding as of July 30, 2010 |
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Common Stock, no par value
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17,203,108 shares |
Rockwell Medical Technologies, Inc.
Index to Form 10-Q
2
PART I FINANCIAL INFORMATION
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Item 1. |
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Financial Statements |
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of June 30, 2010 and December 31, 2009
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June 30, |
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December 31, |
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2010 |
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2009 |
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(unaudited) |
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ASSETS |
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Cash and Cash Equivalents |
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$ |
24,199,534 |
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$ |
23,038,095 |
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Accounts Receivable, net of a reserve of $30,000 in 2010 and $31,000 in 2009 |
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4,598,332 |
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3,492,622 |
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Inventory |
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2,863,461 |
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3,088,352 |
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Other Current Assets |
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451,158 |
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329,876 |
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Total Current Assets |
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32,112,485 |
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29,948,945 |
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Property and Equipment, net |
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3,431,426 |
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3,631,549 |
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Intangible Assets |
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198,521 |
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214,337 |
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Goodwill |
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920,745 |
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920,745 |
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Other Non-current Assets |
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163,706 |
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163,645 |
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Total Assets |
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$ |
36,826,883 |
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$ |
34,879,221 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Capitalized Lease Obligations |
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$ |
27,280 |
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$ |
42,938 |
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Accounts Payable |
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3,441,891 |
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3,388,757 |
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Accrued Liabilities |
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1,831,253 |
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1,854,347 |
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Customer Deposits |
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630,448 |
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250,915 |
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Total Current Liabilities |
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5,930,872 |
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5,536,957 |
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Capitalized Lease Obligations |
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9,365 |
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19,062 |
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Shareholders Equity: |
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Common Shares, no par value, 17,202,108 and 17,200,442 shares issued and
outstanding |
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55,062,172 |
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53,545,394 |
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Common Share Purchase Warrants, 3,328,569 and 3,318,569 warrants issued
and outstanding |
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7,959,023 |
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7,635,594 |
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Accumulated Deficit |
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(32,134,549 |
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(31,857,786 |
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Total Shareholders Equity |
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30,886,646 |
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29,323,202 |
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Total Liabilities and Shareholders Equity |
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$ |
36,826,883 |
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$ |
34,879,221 |
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The accompanying notes are an integral part of the consolidated financial statements.
3
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and six months ended June 30, 2010 and June 30, 2009
(Unaudited)
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Three Months Ended |
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Three Months Ended |
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Six Months Ended |
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Six Months Ended |
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June 30, 2010 |
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June 30, 2009 |
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June 30, 2010 |
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June 30, 2009 |
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Sales |
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$ |
15,506,712 |
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$ |
13,013,012 |
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$ |
30,486,664 |
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$ |
25,809,784 |
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Cost of Sales |
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12,735,047 |
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11,153,086 |
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25,401,470 |
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22,756,911 |
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Gross Profit |
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2,771,665 |
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1,859,926 |
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5,085,194 |
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3,052,873 |
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Selling, General and Administrative |
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2,221,336 |
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1,570,688 |
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4,416,239 |
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3,131,503 |
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Research and Product Development |
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441,273 |
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1,996,571 |
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958,688 |
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3,334,881 |
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Operating Income (Loss) |
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109,056 |
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(1,707,333 |
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(289,733 |
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(3,413,511 |
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Interest Expense (Income), Net |
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(7,861 |
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7,238 |
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(12,970 |
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16,503 |
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Net Income (Loss) |
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$ |
116,917 |
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$ |
(1,714,571 |
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$ |
(276,763 |
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$ |
(3,430,014 |
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Basic Earnings (Loss) per Share |
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$ |
0.01 |
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($0.12 |
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($0.02 |
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($0.25 |
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Diluted Earnings (Loss) per Share |
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$ |
0.01 |
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($0.12 |
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($0.02 |
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($0.25 |
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The accompanying notes are an integral part of the consolidated financial statements.
4
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six months ended June 30, 2010 and June 30, 2009
(Unaudited)
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For the six months ended June 30, |
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2010 |
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2009 |
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Cash Flows From Operating Activities: |
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Net (Loss) |
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$ |
(276,763 |
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$ |
(3,430,014 |
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Adjustments To Reconcile Net Loss To Net Cash Used In
Operating Activities: |
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Depreciation and Amortization |
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707,749 |
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527,292 |
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Loss (Gain) on Disposal of Assets |
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16,822 |
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(5,120 |
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Share Based Compensation Non-employee Warrants |
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323,429 |
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256,362 |
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Share Based Compensation Employees |
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1,511,630 |
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773,833 |
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Changes in Assets and Liabilities: |
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(Increase)Decrease in Accounts Receivable |
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(1,105,710 |
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484,707 |
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Decrease in Inventory |
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224,891 |
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348,313 |
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(Increase) Decrease in Other Assets |
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(121,343 |
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4,898 |
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Increase (Decrease) in Accounts Payable |
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53,134 |
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(191,036 |
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Increase (Decrease) in Other Liabilities |
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356,439 |
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(492,749 |
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Changes in Assets and Liabilities |
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(592,589 |
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154,133 |
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Cash Provided by (Used) In Operating Activities |
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1,690,278 |
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(1,723,514 |
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Cash Flows From Investing Activities: |
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Purchase of Equipment |
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(509,432 |
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(589,008 |
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Proceeds on Sale of Assets |
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800 |
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5,120 |
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Purchase of Intangible Assets |
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(10,257 |
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Cash (Used ) In Investing Activities |
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(508,632 |
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(594,145 |
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Cash Flows From Financing Activities: |
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Issuance of Common Shares and Purchase Warrants |
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5,148 |
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140,502 |
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Payments on Notes Payable |
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(25,355 |
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(84,030 |
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Cash Provided (Used) By Financing Activities |
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(20,207 |
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56,472 |
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Increase (Decrease) In Cash and Cash Equivalents |
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1,161,439 |
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(2,261,187 |
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Cash and Cash Equivalents at Beginning of Period |
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23,038,095 |
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5,596,645 |
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Cash and Cash Equivalents at End of Period |
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$ |
24,199,534 |
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$ |
3,335,458 |
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Supplemental Cash Flow disclosure |
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2010 |
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2009 |
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Interest Paid |
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$7,415 |
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$16,503 |
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The accompanying notes are an integral part of the consolidated financial statements
5
Rockwell Medical Technologies, Inc. and Subsidiary
Notes to Consolidated Financial Statements
1. Description of Business
Rockwell Medical Technologies, Inc. and Subsidiary (collectively, we, our, us, or the
Company) 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 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. We also have 510(k) approval
to sell our Dri-Sate Dry Acid Concentrate product line and our Dri-Sate Mixer.
We have 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 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, 2009 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 and six month periods ended June 30, 2010 are not
necessarily indicative of the results to be expected for the year ending December 31, 2010. You
should read our unaudited interim financial statements together with the financial statements and
related footnotes for the year ended December 31, 2009 included in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2009. Our Annual Report on Form 10-K for the fiscal year
ended December 31, 2009 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 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 our terms of sale. At June 30, 2010 and December
31, 2009 we had customer deposits of $630,448 and $250,915, respectively.
6
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.
Research and Product Development
We recognize research and product development costs as expenses are incurred. We incurred
research and product development costs related to the commercial development, patent approval
and regulatory approval of new products, including iron supplemented dialysate (SFP),
aggregating approximately $1.0 million and $3.3 million in the first half of 2010 and 2009,
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. We completed a Phase 2 study of SFP in 2009 and intend to start our Phase 3
program in late 2010 as well as other related studies during the second half of 2010.
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:
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Three months ended June 30, |
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Six months ended June 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Basic Weighted Average Shares Outstanding |
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17,086,723 |
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13,990,688 |
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17,069,297 |
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13,985,006 |
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Effect of Dilutive Securities |
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1,519,151 |
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Diluted Weighted Average Shares Outstanding |
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18,605,874 |
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13,990,688 |
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17,069,297 |
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13,985,006 |
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3. Inventory
Components of inventory as of June 30, 2010 and December 31, 2009 are as follows:
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June 30, |
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December 31, |
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2010 |
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2009 |
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Raw Materials |
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$ |
1,046,925 |
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$ |
1,051,781 |
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Work in Process |
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172,679 |
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196,603 |
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Finished Goods |
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1,643,857 |
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1,839,968 |
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Total |
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$ |
2,863,461 |
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$ |
3,088,352 |
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4. Subsequent Event
The Company renewed its lease on its Grapevine, Texas facility for a sixty four month term
ending December 31, 2015. The Company is obligated to pay base rent totaling $830,586 over the
term of the lease beginning January 1, 2011 as well as certain other operating expenses. The
Company is obligated to make monthly payments of base rent commencing January 1, 2011 through
lease termination. The Company may renew the lease for an additional five year term at rental
rates prevailing at the time of renewal.
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.
7
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, 2009 as modified by our Quarterly Report on Form 10-Q for the period ended
March 31, 2010.
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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 flow. |
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We operate in a very competitive market against substantially larger competitors with
greater resources. |
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Our new drug product requires FDA approval and expensive clinical trials before it can be
marketed. |
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Even if our new drug product is approved by the FDA, we may not be able to market it
successfully. |
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We may not be successful in maintaining our gross profit margins. |
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We depend on government funding of healthcare. |
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Orders from our international distributors may not result in recurring revenue. |
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We depend on key personnel. |
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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. |
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Foreign approvals to market our new drug products may be difficult to obtain. |
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Health care reform could adversely affect our business. |
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We may not have sufficient product liability insurance. |
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Our Board of Directors is subject to potential deadlock. |
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Shares eligible for future sale may affect the market price of our common shares. |
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The market price of our securities may be volatile. |
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Voting control and anti-takeover provisions reduce the likelihood that you will receive a
takeover premium. |
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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 flow 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
Rockwell Medical operates in a single business segment as a specialty pharmaceutical company
offering innovative products targeting end-stage renal disease, chronic kidney disease, and iron
deficiency anemia. As an established manufacturer delivering high-quality hemodialysis
concentrates to dialysis providers and distributors in the U.S. and abroad, we provide products
used to maintain human life, remove toxins and replace critical nutrients in the dialysis patients
bloodstream.
We are currently developing unique, proprietary renal drug therapies. These exclusive 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.
Our strategy is to develop high potential drug candidates while also expanding our dialysis
products business, which had sales of $54.7 million in 2009 and approximately $30.5 million in the
first half of 2010. Our research and development expenses were $1.0 million in the first half of
2010 compared to $3.3 million in the first half of 2009 when we were conducting a Phase 2b clinical
trial of SFP, our lead drug candidate.
We believe our SFP product has unique and substantive benefits compared to current treatment
options and has the potential to compete in the iron maintenance therapy market. The cost to
obtain regulatory approval for a drug in the United States is expensive and can take several years.
We believe that our cash resources will be sufficient to complete the SFP testing, FDA approval
process and our other planned research and development activities.
We could experience changes in our customer and product mix in future quarters that could
impact gross profit, since we sell a wide range of products with varying profit margins and to
customers with varying order patterns. These changes in mix may cause our gross profit and our
gross profit margins to vary period to period. We anticipate a continued increase in fuel and other
costs in 2010 along with competitive pricing pressures in the renal market.
The majority of our business is with domestic clinics who order routinely. Certain major
distributors of our products internationally have not ordered consistently, however, 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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Results of Operations for the Three and Six Months Ended June 30, 2010 and June 30, 2009
Sales
Sales in the second quarter of 2010 were $15.5 million, an increase of $2.5 million or 19.2%
over the second quarter of 2009. Sales for the first six months of 2010 were $30.5 million, an
increase of $4.7 million or 18.1% over the first half of 2009. The increases were due to
increased sales with a single international distributor whose orders are dependent upon its success
at winning local or national tenders. Sales to this single distributor increased $3.0 million and
$5.3 million for the three and six month periods ended June 30, 2010 compared to the same periods
in 2009. Our other international business also increased with second quarter sales up $0.1 million
compared to the second quarter of 2009 and sales in the first six months of 2010 up $0.4 million
compared to the first six months of 2009. Our domestic sales decreased $650,000 and $1.0 million
in the second quarter and first six months of 2010 compared to the same periods in 2009. Lower
domestic sales were largely the result of a change in product mix reflecting a migration by
customers to lower cost formulations and conversion to our Dri-Sate Dry Acid concentrate product
line, both of which result in lowering providers cost per treatment while improving our gross
profit margins. We realized a significant shift to our Dri-Sate Dry Acid concentrate product line
with unit volumes increasing by 41% in the second quarter of 2010 compared to the second quarter of
2009 and 38% in the first six months of 2010 compared to the first six months of 2009, which
reflects a continuing trend by our customers to convert from liquid to dry acid concentrate.
Gross Profit
Gross profit in the second quarter of 2010 was $2.8 million, an increase of $0.9 million or
49% over the second quarter of 2009. Gross profit margins were 17.9% in the second quarter of 2010
compared to 14.3% in the second quarter of 2009. Gross profit for the first half of 2010 was $5.1
million compared to $3.1million in the first half of 2009 with gross profit margins of 16.7% in the
first half of 2010 compared to 11.8% in the first half of 2009. Substantial changes in product and
customer mix coupled with increases in overall sales volumes improved our gross profit margins
compared to the second quarter and first half of last year. Domestic sales migrated toward our
Dri-Sate Dry Acid concentrate product line, which provides a cost effective alternative to higher
cost per treatment liquid products and which cost us less to deliver than liquid products.
Customers also migrated toward lower cost formulations, which improved margins while not increasing
costs to our customers. Over the last year, we incurred only moderate increases in material, fuel
and other operating costs while continuing to moderately increase our selling prices on maturing
contracts. Average diesel fuel costs increased approximately 30% per gallon in the first half of
2010 compared to the first half of 2009 and were in line with our expectations of increased fuel
costs in 2010.
Selling, General and Administrative Expense
Selling, general and administrative (SG&A) expense during the second quarter of 2010 was $2.2
million an increase of $650,000 over the second quarter of 2009. The increase was primarily due to
higher non-cash equity compensation of $0.4 million and due to increased personnel costs of $0.3
million. Personnel costs were higher due to a combination of compensation for new positions,
increased performance bonuses, wage inflation and higher benefit costs.
SG&A was $4.4 million in the first six months of 2010 compared to $3.1 million in the first
six months of 2009. The increase was primarily due to higher non-cash equity compensation expense
of $0.8 million and increased personnel costs of $0.5 million due to the aforementioned reasons.
Research and Development
Research and development (R&D) costs were $0.4 million and $2.0 million in the second quarter
of 2010 and 2009, respectively. R&D costs were $1.0 million in the first six months of 2010
compared to $3.3 million in the first six months of 2009. Spending in both years was primarily for
development and approval of SFP. During 2009, we conducted a Phase 2b study which was completed
in late 2009. We plan to commence our SFP Phase 3 clinical trials
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in the latter part of 2010 as well as other related studies during the second half of 2010 and
expect to see research and development spending increase when the Phase 3 program commences.
Interest Income, Net
Our net interest income was $7,861 in the second quarter of 2010 compared to a net interest
expense of $7,238 in the second quarter of 2009. Net interest income in the first six months of
2010 was $12,970 compared to a net interest expense of $16,503 in the first half of 2009. The
increase in interest income was the result of the investment of the proceeds of the October 2009
equity offering in short term investments. However, we do not expect that this investment will
continue to materially increase interest income due to the current low short term interest rate
environment.
Liquidity and Capital Resources
We expect to expend substantial amounts in support of our clinical development plan and
regulatory approval of SFP and its extensions. Although these initiatives will require the
expenditure of substantial cash resources, we believe our cash resources will be sufficient to fund
our Phase 3 clinical program. Our cash resources include cash generated from our business
operations and the $20.4 million in net proceeds from our equity offering in October 2009. Our
current assets exceeded our current liabilities by over $26.2 million as of June 30, 2010 and
included $24.2 million in cash and cash equivalents.
In the first half of 2010, our cash increased by $1.2 million as a result of cash flow
generated from operations of $1.7 million offset by $0.5 million in capital expenditures. Cash
provided by operations totaled $1.7 million for the first six months of 2010 and was primarily the
result of $2.3 million in cash generated from business operations partially offset by an increase
in accounts receivable of $1.1 million. Accounts receivable as of June 30, 2010 increased $1.1
million compared to December 31, 2009 as a result of a large early payment made prior to year end
which temporarily decreased accounts receivable. We also realized a $0.2 million reduction in
inventory due to normal inventory fluctuation. Our customer deposits increased by $0.4 million due
to increased international demand for our products.
We believe our cash resources are sufficient to fund our anticipated research and development
activities as well as our ordinary operating cash requirements in the next 12 months. We expect to
continue to generate positive cash flow from operations in 2010, excluding the effect of our
research and development expenses, assuming stable operating results and relative stability in the
markets for our key raw materials. However, if we use more cash than anticipated for SFP
development, or are required to do more testing than expected or if the assumptions underlying our
cash flow projections for 2010 and 2011 prove to be incorrect, we may 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. Alternatively, we may seek to enter into development
arrangements with an international partner in order to fully execute our strategic plan. We may
also evaluate alternative sources of business development funding, licensing agreements with
international marketing partners, sub-licensing of certain products for certain markets and other
potential funding sources.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
Our current exposure to interest rate risk is limited to changes in interest rates on short
term investments of cash. As of June 30, 2010, we had $20.5 million in short term investments in a
money market fund.
A hypothetical 100 basis point increase in market interest rates for short term liquid
investments would increase our annualized interest income by approximately $0.2 million, assuming
we invested $20.5 million in cash and that
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level remained constant for the year. We did not perform an analysis of a 100 basis point
decrease in market interest rates as such an analysis would be meaningless given the current market
rates.
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, 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 June 30, 2010 that materially
affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
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 2009 Annual Report on Form 10-K. Other than as previously updated in our Form 10-Q for the
quarter ended March 31, 2010, there have been no material changes to the risk factors set forth in
Item 1A of our Form 10-K for the year ended December 31, 2009.
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Item 6. Exhibits
See Exhibit Index following the 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.
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ROCKWELL MEDICAL TECHNOLOGIES, INC.
(Registrant)
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Date: August 5, 2010 |
/s/ ROBERT L. CHIOINI
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Robert L. Chioini |
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President and Chief Executive
Officer
(principal executive officer)
(duly authorized officer) |
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Date: August 5, 2010 |
/s/ THOMAS E. KLEMA
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Thomas E. Klema |
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Vice President and Chief Financial Officer
(principal financial officer and
principal accounting officer) |
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10-Q EXHIBIT INDEX
The following exhibits are filed as part of this report (unless otherwise noted to be
previously filed, and therefore incorporated herein by reference). Our SEC file number is
000-23661.
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Exhibit No. |
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Description |
10.35
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Third Amendment to Industrial Lease Agreement between Rockwell Medical Technologies,
Inc. and DCT DFW, LP dated July 7, 2010 (Companys Form 8-K filed on July 13, 2010). |
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10.36
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Amendment No. 3 to Rockwell Medical Technologies, Inc. 2007 Long Term Incentive Plan
(Companys Proxy Statement filed April 15, 2010). |
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31.1
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 |
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31.2
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Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 |
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32.1
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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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