e10vq
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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 September 30, 2007
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
incorporation or organization)
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(I.R.S. Employer
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 is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
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 October 31, 2007 |
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Common Stock, no par value
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11,634,749 shares |
Rockwell Medical Technologies, Inc.
Index to Form 10-Q
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of September 30, 2007 and December 31, 2006
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SEPTEMBER 30, |
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DECEMBER 31, |
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2007 |
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2006 |
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(Unaudited) |
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ASSETS |
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Cash and Cash Equivalents |
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$ |
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$ |
2,662,873 |
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Accounts Receivable, net of a reserve of $105,930 in
2007 and $72,500 in 2006 |
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4,918,464 |
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3,474,402 |
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Inventory |
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2,793,993 |
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2,660,098 |
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Other Current Assets |
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317,716 |
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261,473 |
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Total Current Assets |
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8,030,173 |
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9,058,846 |
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Property and Equipment, net |
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2,841,601 |
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2,587,771 |
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Intangible Assets |
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428,930 |
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457,846 |
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Goodwill |
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920,745 |
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920,745 |
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Other Non-current Assets |
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125,667 |
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127,625 |
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Total Assets |
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$ |
12,347,116 |
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$ |
13,152,833 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Short Term Borrowings |
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$ |
1,800,000 |
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$ |
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Notes Payable & Capitalized Lease Obligations |
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232,984 |
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369,551 |
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Accounts Payable |
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2,971,652 |
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2,920,258 |
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Accrued Liabilities |
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851,856 |
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1,114,592 |
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Customer Deposits |
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45,729 |
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48,274 |
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Total Current Liabilities |
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5,902,221 |
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4,452,675 |
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Long Term Notes Payable & Capitalized Lease Obligations |
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240,734 |
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326,045 |
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Shareholders Equity: |
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Common Shares, no par value, 11,634,749 and 11,500,349
shares issued and outstanding |
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23,533,808 |
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23,147,709 |
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Accumulated Deficit |
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(17,329,647 |
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(14,773,596 |
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Total Shareholders Equity |
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6,204,161 |
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8,374,113 |
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Total Liabilities And Shareholders Equity |
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$ |
12,347,116 |
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$ |
13,152,833 |
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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 nine months ended September 30, 2007 and September 30, 2006
(Whole dollars)
(Unaudited)
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Three Months |
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Three Months |
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Nine Months |
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Nine Months |
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Ended |
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Ended |
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Ended |
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Ended |
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Sept. 30, 2007 |
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Sept. 30, 2006 |
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Sept. 30, 2007 |
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Sept. 30, 2006 |
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Sales |
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$ |
11,073,774 |
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$ |
7,379,201 |
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$ |
31,096,399 |
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$ |
19,410,357 |
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Cost of Sales |
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9,953,863 |
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6,785,796 |
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28,942,171 |
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17,568,497 |
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Gross Profit |
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1,119,911 |
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593,405 |
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2,154,228 |
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1,841,860 |
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Selling, General and Administrative |
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765,457 |
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592,767 |
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2,288,903 |
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1,912,544 |
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Research and Product Development |
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735,393 |
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1,621,821 |
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2,319,452 |
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3,381,643 |
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Operating (Loss) |
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(380,939 |
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(1,621,183 |
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(2,454,127 |
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(3,452,327 |
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Interest Expense (Income), net |
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51,973 |
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486 |
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101,924 |
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(32,383 |
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Net (Loss) |
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($432,912 |
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($1,621,669 |
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($2,556,051 |
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($3,419,944 |
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Basic Earnings (Loss) per Share |
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($.04 |
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($.14 |
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($.22 |
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($.31 |
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Diluted Earnings (Loss) per Share |
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($.04 |
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($.14 |
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($.22 |
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($.31 |
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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 nine months ended September 30, 2007 and September 30, 2006
(Unaudited)
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2007 |
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2006 |
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Cash Flows From Operating Activities: |
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Net (Loss) |
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($2,556,051 |
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($3,419,944 |
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Adjustments to Reconcile Net (Loss) to Net Cash Used for
Operating Activities: |
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Depreciation and Amortization |
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601,362 |
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542,480 |
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Loss on Disposal of Equipment |
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653 |
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Changes in Assets and Liabilities: |
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(Increase) Decrease in Accounts Receivable |
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(1,444,062 |
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87,245 |
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(Increase) in Inventory |
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(133,895 |
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(495,316 |
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(Increase) in Other Assets |
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(54,285 |
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(59,408 |
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Increase in Accounts Payable |
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51,394 |
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629,688 |
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Increase (Decrease) in Customer Deposits |
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(2,545 |
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353,124 |
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(Decrease) in Accrued Liabilities |
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(262,736 |
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(42,008 |
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Changes in Assets and Liabilities |
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(1,846,129 |
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473,325 |
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Cash (Used In) Operating Activities |
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(3,800,818 |
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(2,403,486 |
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Cash Flows from Investing Activities: |
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Purchase of Equipment |
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(766,314 |
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(522,937 |
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Purchase of Intangible Assets |
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(6,286 |
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(104,115 |
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Cash (Used In) Investing Activities |
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(772,600 |
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(627,052 |
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Cash Flows From Financing Activities: |
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Proceeds from Borrowing on Line of Credit |
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1,800,000 |
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Payments on Line of Credit |
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(1,800,000 |
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Payments on Notes Payable and Capital Lease Obligations |
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(275,554 |
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(442,836 |
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Issuance of Common Shares |
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386,099 |
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9,008,859 |
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Cash Provided By Financing Activities |
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1,910,545 |
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6,766,023 |
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Increase (Decrease) In Cash |
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(2,662,873 |
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3,735,485 |
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Cash At Beginning Of Period |
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2,662,873 |
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299,031 |
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Cash At End Of Period |
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$ |
-0- |
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$ |
4,034,516 |
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Supplemental Cash Flow Disclosure: |
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Interest Paid |
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$ |
108,159 |
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$ |
102,304 |
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Non-Cash Investing and Financing Activity
Equipment Acquired Under Capital Lease Obligations |
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$ |
53,676 |
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$ |
45,940 |
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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
We manufacture, sell and distribute hemodialysis concentrates and other ancillary medical
products and supplies used in the treatment of patients with End Stage Renal Disease, or
ESRD. We supply our products to medical service providers who treat patients with kidney
disease. Our products are used to cleanse patients blood and replace nutrients lost during
the kidney dialysis process. We primarily sell our products in the United States.
We are regulated by the Federal Food and Drug Administration, FDA, under the Federal
Drug and Cosmetics Act, as well as by other federal, state and local agencies. We 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.
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 Rule 10-01 of 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, 2006 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 nine month
periods ended September 30, 2007 are not necessarily indicative of the results to be expected
for the year ending December 31, 2007. You should read our unaudited interim financial
statements together with the financial statements and related footnotes for the year ended
December 31, 2006 included in our Annual Report on Form 10-KSB for the fiscal year ended
December 31, 2006. Our Annual Report on Form 10-KSB for the fiscal year ended December 31,
2006 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 our products
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
September 30, 2007 and December 31, 2006 we had customer deposits of $45,729 and $48,274,
respectively.
6
In the quarter ended March 31, 2006, we reached a settlement with a customer related to
its breach of several purchase contracts. Under the terms of the settlement, we were paid
$755,000 in exchange for release of the customers future obligations under these contracts.
All of this settlement was recognized as a component of revenue in 2006.
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, aggregating
approximately $2,319,452 and $3,381,643 in the first nine months of 2007 and 2006,
respectively.
During 2006, we entered into a number of research and development related contracts for
safety, pharmacology and toxicology testing of our iron dialysate drug product under which we
made commitments to spend $3.4 million. Services under the contracts were to be performed over
periods ranging from 3 to 15 months. We recognized the cost of these contracts as research and
development expense over the periods in which the testing was performed and on a basis
reflective of the level of activity under those contracts in each period. During 2006, we
expensed approximately $2.9 million under these contracts. In the first nine months of 2007,
we expensed $.5 million, which constituted the remainder of the costs under these contracts.
Earnings Per Share
We computed our basic earnings 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 Sept. 30, |
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Nine months ended Sept. 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Basic Weighted Average Shares Outstanding |
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11,619,117 |
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11,463,210 |
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11,545,725 |
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11,090,338 |
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Effect of Dilutive Securities |
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Diluted Weighted Average Shares Outstanding |
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11,619,117 |
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11,463,210 |
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11,545.725 |
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11,090,338 |
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3. Inventories
Components of inventory as of September 30, 2007 and December 31, 2006 are as follows:
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September 30, |
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December 31, |
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2007 |
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2006 |
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Raw Materials |
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$ |
913,595 |
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$ |
717,876 |
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Finished Goods |
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1,880,398 |
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1,942,222 |
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Total Inventory |
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$ |
2,793,993 |
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$ |
2,660,098 |
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4. Line of Credit
On March 23, 2007, we renewed our line of credit with a financial institution. The loan
agreement provides for revolving borrowings by us of up to $2,750,000. We are permitted to
borrow up to 80% of our eligible accounts receivable and up to 40% of our eligible inventory up
to $600,000. Borrowings under the loan agreement are secured by accounts receivable, inventory
and certain other assets. The annual interest rate payable on revolving borrowings under the
loan agreement is the lenders prime rate plus 75 basis points.
The credit agreement contains a covenant which limits our ability to incur other indebtedness and a
financial covenant requiring a minimum level of tangible net worth.
7
The lenders commitment to make revolving
borrowings under the loan agreement expires on April 1, 2008. As of September 30, 2007, we had
outstanding borrowings of $1,800,000 under this line of credit.
5. Long-Term Incentive Plan
On May 24, 2007, the shareholders approved the adoption of a long term incentive plan (LTIP).
The Company has reserved an aggregate of 1,000,000 Common Shares that can be awarded under the
LTIP. The Compensation Committee may grant stock options, restricted stock, restricted stock units
and performance based cash or stock based awards under the LTIP. No equity grants had been issued
under the plan as of September 30, 2007.
The Companys 1997 Stock Option Plan terminated as to future grants on May 24, 2007.
Immediately prior to termination of future grants, 489,856 shares were available for grant. No
stock options were granted under the 1997 Stock Option Plan during 2007.
6. Recent Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board issued Financial Interpretation No. 48,
Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48, which is an interpretation of
Statement of Financial Accounting Standards No. 109, Accounting for Income Taxes, provides
guidance on the manner in which tax positions taken or to be taken on tax returns should be
reflected in an entitys financial statements prior to their resolution with taxing authorities.
The adoption of the provisions of this pronouncement did not have a material impact on our
financial position or results of operations.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward Looking Statements
The following discussion and analysis should be read in conjunction with the Consolidated
Financial Statements and the Notes thereto included elsewhere in this report. The discussion that
follows contains certain forward-looking statements relating to our anticipated future financial
condition, operating results, cash flows and our current business plans. 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.
These forward-looking statements represent our outlook only as of the date of this report. 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. 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 in this report and from time to time in our other reports filed with the Securities and
Exchange Commission, including under Item 1 Description of Business Risk Factors and Forward
Looking Statements in our Form 10-KSB for the year ended December 31, 2006 and the following:
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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. |
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We operate in a very competitive market against substantially larger competitors with
greater resources. |
8
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Orders from our international distributors may not result in recurring revenue. |
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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 it may not be successfully marketed,
and may not be eligible for Medicare reimbursement. |
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We depend on government funding of healthcare. |
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We may not have sufficient cash to operate the business. |
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The market price of our securities may be volatile. |
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We may not be successful in improving our gross profit margins and our business may not
achieve an acceptable level of profitability. |
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Our suppliers may increase their prices faster than we are able to raise our prices to
offset such increases. We may have limited ability to gain a raw material pricing advantage by
changing vendors for certain raw materials. |
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We depend on key personnel. |
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Our business is highly regulated. |
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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 products liability insurance. |
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. While we believe that the forward-looking statements in this report are
reasonable, the reader should not place undue reliance on any forward-looking statement. 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 aggregate sales
in the first nine months of 2007 increased 60% compared to the nine months ended September 30,
2006. 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 this market.
Our strategy is also to expand the geographic footprint of our business in North America.
We realized a unique business opportunity to do so in the last quarter of 2006 and the first
quarter of 2007 due to the exit of one of our competitors, Gambro, from the market. Concurrent
with Gambros withdrawal from the concentrate business, we began to service many of the chain
and independent clinics serviced by Gambro, including many clinics owned by DaVita, Inc., the
second largest U.S. dialysis provider. During the first nine months of 2007, the number of
clinics we service increased by over 50%.
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We intend to continue to increase the size of our customer portfolio in order to expand
our production and distribution operations into regions where we previously had business but no
production facility. We believe this strategic initiative will ultimately lead to efficiencies
and economies of scale, and will position the Company for an adequate and sustainable return on
investment. We anticipate that we will continue to gain domestic market share.
As a result of the dramatic increase in sales volume and the increased geographic
diversity of the clinics we serve, we took actions during the first quarter of 2007 to ensure
adequacy of product supply and uninterrupted order fulfillment for the new business we added.
Our main initiative in this regard was to relocate one of our production facilities in a region
where the additional business we acquired had outstripped our ability to properly supply,
distribute and service the business. As a result of this relocation, we incurred costs
aggregating approximately $500,000 for physical relocation, extra labor, plant start-up
expenses, distribution start-up expenses, inventory write-offs and dual facility operating
costs during the start-up period. Although these costs are not expected to recur at this
location, we expect to incur similar types of costs in other regions as we continue to adjust
our production and distribution facilities to meet new or changing demand.
We are in the process of raising our average selling prices in 2007 in part to offset these
additional costs and the higher costs of raw materials and fuel. In the second quarter of 2007, we
implemented price increases with an overall weighted average annual impact on gross profit margins
of approximately 6%. Price increases on other maturing contracts have been and are expected to be
renewed at higher-than-current rates throughout the remainder of 2007 and in 2008. If we are
successful in implementing these increases, our gross profit margins may continue to improve and
increase the profitability of our core business operations with our gross profit exceeding our
selling, general and administrative expenses in those quarters. However, we could experience
changes in our customer and product mix in future quarters that could negatively impact gross
profit. Since we sell a wide range of products with varying profit margins and to customers with
varying order patterns, our gross profit and our gross profit margins could vary period to period.
As we add business in certain markets and regions in order to increase the scale of our business
operations, we may incur additional costs that are greater than the additional revenue generated
from these initiatives until we have achieved a scale of operations that is profitable.
Increased operating costs that are subject to inflation, such as fuel and material costs, may
not be recoverable through price increases to our customers if our competitors do not also raise
prices. If we are not able to recover cost increases, it could materially adversely affect our
business, financial condition and results of operations. We generally enter into short and medium
term contracts of one to two years for our major raw materials and we generally enter into customer
contracts of similar duration to mitigate our exposure to raw material and other cost increases.
The dialysis supply market is very competitive and is characterized by having a few dialysis
providers treating the majority of patients in the United States. We compete against companies
which have substantially greater resources than we have. Our revenue is highly concentrated in a
few customers and the loss of any of those customers would adversely affect our results. However,
we expect to continue to grow our business while executing our strategic plan to expand our product
lines, to expand our geographic reach and to develop our proprietary technology, which may include
adding facilities and personnel to support our growth.
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 international 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
quarters or may not recur at all.
We are seeking to gain FDA approval for our iron supplemented dialysate product, soluble
ferric pyrophosphate (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 in
the iron maintenance therapy market. The cost to obtain
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regulatory approval for a drug in the United States is expensive and can take several years.
We expect to devote substantial resources to this drug approval effort until it is completed.
Results of Operations for the Three and Nine Months Ended September 30, 2007 and September 30, 2006
Sales
Sales
in the third quarter of 2007 were $11.1 million and were $3.7 million or 50% higher than
the third quarter of 2006. Our substantial revenue growth over the third quarter of 2006 was
almost entirely due to domestic sales growth. Growth in our domestic business over the last year
has been mainly due to the exit of Gambro from our market and the contraction of another
competitor. Concurrent with Gambros exit from the concentrate market, we began to service a
significant portion of the DaVita clinics formerly serviced by Gambro and have gained a substantial
amount of new business from other dialysis providers over the last year.
We realized substantial sales growth in our domestic business in 2007 primarily due to growth
in national and regional chain accounts. Our domestic sales increased by 80.8% in the third
quarter of 2007 compared to the third quarter of 2006. Approximately 75% of the domestic sales
increase was due to increased unit volumes across our dialysis concentrate product lines, with the
remainder attributable to higher prices.
Our sales to both foreign and domestic based international distributors of our products was
approximately $470,000 in the third quarter of 2007 or 4.3% of our total sales. These
international sales decreased $1.1 million in the third quarter of 2007 compared to the third
quarter last year primarily due to approximately $1.25 million in orders from major distributors
for certain business in Latin America in the third quarter of 2006 that were not renewed in 2007.
International orders to Latin America, which did not recur in the third quarter of 2007,
represented approximately 16% of sales in the third quarter of 2006. Our other international
business increased approximately 60% over the third quarter of 2006.
Sales of our dialysis concentrate product lines, which represented over 93% of our sales
in the third quarter of 2007, increased approximately 47% in the third quarter of 2007 compared to
the third quarter of 2006. The primary increase in sales was in our liquid and powder acid
concentrate products, sales of which increased approximately 87% predominantly due to a 107%
increase in liquid acid gallons sold.
Our sales in the first nine months of 2007 were $31.1 million, an increase of $11.7
million or 60.2% over the sales in the first nine months of 2006. This increase was largely due
to the market share gains and domestic sales growth resulting from the exit of Gambro and the
contraction of another competitor as discussed above, partially offset by the effect of a breach of
contract settlement that increased sales by $755,000 in the first quarter of 2006. Domestic sales
in the first nine months of 2007 increased by 72% over the first nine months of 2006. Unit volume
increases in our business accounted for the majority of the domestic sales increase in the first
nine months of 2007 compared to the first nine months of 2006.
Sales to DaVita clinics represented approximately 74% of the total increase in domestic sales
while growth in sales to other national chains, regional chains and other independent clinics
increased by over 32% and represented slightly over 26% of the growth in domestic business in the
first nine months of 2007 compared to the first nine months of 2006. Our international sales were
approximately 5% of total sales in the first nine months of 2007 compared to 12.1% of total sales
in the first nine months of 2006. The decrease in international sales was attributable to the
above mentioned orders from Latin America in 2006.
Gross Profit
Gross profit in the third quarter of 2007 increased by $527,000 or 89% to $1.1 million
compared to $.6 million in the third quarter of 2006. Gross profit margins increased to 10.1% from
8.0% in the third quarter of 2006. This increase in gross profit and
margins was due to a
combination of higher prices and higher volume of products sold. We have increased prices on
maturing contractual arrangements resulting from rising raw material, fuel and other operating
costs incurred over the last year.
Gross profit in the first nine months of 2007 increased by $312,000 to $2.2 million
compared to $1.8 million in the first nine months of 2006. Gross profit margins decreased to 6.9%
from 9.5% primarily due to the impact of the aforementioned $755,000 breach of contract settlement
received in 2006 and the $500,000 of facility relocation costs incurred in the first quarter of
2007. Some of the new business we added was in geographic areas that were distant from our
facilities. In order to improve the margins on our new business we have and continue to expect to
raise prices and to better position our supply chain to service
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this business. We anticipate that gross profit and gross profit margins may fluctuate in future
interim periods depending upon the timing of price increases compared to material cost increases
and the cost of additional facility relocation or expansion.
Selling, General and Administrative Expense
Selling, general and administrative expense, or SG&A during the third quarter of 2007
decreased as a percent of sales to 6.9% from 8.0% in the third quarter of 2006 due to our increased
sales. However, overall SG&A expense increased by $172,690 or 29% during the third quarter of 2007
compared to the third quarter of 2006. The increase in costs was primarily due to increased
resources to support our overall growth over the last year, including additional personnel and
information technology resources.
Similarly, in the first nine months of 2007, SG&A expense decreased to 7.4% of sales from
9.9% of sales in the first nine months of 2006. However, SG&A expense increased $376,359 or 19.7%
compared to the first nine months of 2006, mostly due to increased costs to support our growth,
including additional personnel, increased marketing expenditures and investments in information
technology resources.
Research and Development
Research
and development costs were $735,393 or 6.6% of sales compared to
$1,621,821 or 22% of sales in the
third quarter of 2006. 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. Spending
in the third quarter of 2007 was primarily related to preparation to commence human clinical trials
which began in the fourth quarter of 2007. Fourth quarter 2007 R&D spending can be expected to
increase substantially above the third quarter spending level as a result of the human clinical
trials.
In the first nine months of 2007, research and product development expense was $2,319,452 or
7.5% of sales compared to $3,381,643 or 17.4% of sales in the first nine months of 2006. Costs
incurred in 2006 were primarily for non-clinical testing of SFP. Expenditures in 2007 included
expenditures for non-clinical testing and costs related to preparation for human clinical testing.
Interest Expense, Net
Net interest expense increased by $51,487 in the third quarter of 2007 compared to the third
quarter of 2006. Interest expense increased by $26,671 due to increased borrowings under our line
of credit while interest income was $24,816 lower due to short term investment income realized in
the third quarter of 2006.
Net interest expense in the first nine months of 2007 increased $134,307 compared to the first
nine months of 2006 largely due to a decrease in interest income on short term investments of
$128,452. Interest income in 2006 was the result of the investment of the net proceeds of the
stock offering that occurred in the first quarter of 2006. Those funds have been largely used for
the development and approval of SFP.
Liquidity and Capital Resources
We have two major areas of strategic focus in our business. First, we plan to develop our
dialysis products business. Second, we expect to expend substantial amounts in support of our
clinical development plan and regulatory approval of SFP. Both of these initiatives require
investments of substantial amounts of capital.
During
the first nine months of 2007, we used approximately $4.8 million in cash to fund
operating and investing activities and repayment of long term debt. To fund these costs we used our
available cash and borrowed $1.8 million on our line of credit. Much of the borrowing on our credit
line was used to fund the increase in our accounts receivable which increased by $1.4 million
resulting from the overall growth in our business. We do not anticipate our accounts receivable to
increase in the fourth quarter. Similarly, we do not anticipate any significant increases in cash
requirements for operating activities other than research and development. We reduced our long term
debt and capital lease obligations by $222,000 in the first nine months of 2007, which included
$122,000 related to the final payments on a note payable that was repaid in the second quarter of
2007.
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We also incurred certain large cash expenditures to support our 60% sales growth in the
first three quarters of 2007. We used approximately $500,000 in cash in the first quarter of 2007
to fund the relocation and start-up of a new facility. We also incurred approximately $500,000 in
start-up costs for new business and increases in material costs in the first quarter of 2007.
However, we have subsequently increased prices for customers representing over half of our gross
sales, thereby raising our overall margins and improving operating cash flow. Our dialysis products
business showed substantial improvement in operating results in the last two quarters compared to
the first quarter with both sales and gross margins increasing. If we continue to add new business
and realize price increases in excess of material cost increases as anticipated, we expect to
continue to generate increased cash flow from our dialysis products business in the fourth quarter
of 2007, before research and development expenses. Similar to the third quarter, we expect fourth
quarter 2007 results to achieve positive cash flow from operations before research and development
expenditures and thereby mitigate a portion of the cash impact of funding increased research and
development expenditures. As a result, we believe our cash resources and other sources of
liquidity will be adequate to fund our cash requirements for 2007.
We expect to continue to expand our production and distribution network in 2008, which
will require additional capital. We anticipate that we will enter into equipment leasing
arrangements and other lending arrangements to fund the majority of capital expenditures associated
with facility expansions or additions. If we require additional working capital to support facility
or business growth, we believe our current working capital line will be sufficient to meet our
short term working capital needs.
In the first nine months of 2007, our research and development costs were $2.3 million.
Over the next year we anticipate spending approximately $5 $6 million on SFP testing and
approval. In addition, our longer term pharmaceutical product development initiatives and
regulatory approval work will also require sources of funding in addition to cash flows from our
operations. We expect that we will need to borrow additional funds and to raise additional capital
in order to execute our strategic plan. The maximum amount of borrowing permitted under our working
capital line is $2.75 million. As of September 30, 2007, we had borrowed $1.8 million under our
working capital line. The terms of our working capital line are discussed in Note 4 to the
consolidated financial statements. 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. Should we not be able to obtain additional financing, we may be forced
to alter our strategy, delay spending on development initiatives or take other actions to conserve
cash resources.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
Our exposure to interest rate risk is limited to borrowings under our line of credit. Our
borrowings under our line of credit were $1.8 million as of September 30, 2007. A 100 basis point
increase in the prime rate of our lending institution would increase annual interest expense by
$18,000, assuming our borrowing level remained constant for the year.
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 (the
Exchange Act) that are designed to cause the material information required to be disclosed by us
in the reports we file or submit under the Exchange Act to be recorded, processed, summarized, and
reported to the extent applicable within the time periods required by the Securities and Exchange
Commissions rules and forms, and for such information to be accumulated
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and communicated to our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow timely decisions regarding required financial disclosure. In
designing and evaluating the disclosure controls and procedures, management 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, with a company have been detected.
As of the end of the period covered by this report, we performed an evaluation under the
supervision and with the participation of management, including the Chief Executive Officer and
Chief Financial Officer, of the effectiveness of the design and operation of its disclosure
controls and procedures pursuant to Rule 13a-15 of the Exchange Act. Based upon that evaluation,
the Chief Executive Officer and Chief Financial Officer concluded that the 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 last fiscal quarter that materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
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.
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(Registrant) |
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Date: November 8, 2007
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/s/ ROBERT L. CHIOINI |
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Robert L. Chioini |
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President, Chief Executive Officer and Director
(principal executive officer) (duly authorized officer) |
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Date: November 8, 2007
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/s/ THOMAS E. KLEMA |
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Thomas E. Klema |
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Vice President of Finance, Chief Financial Officer, Treasurer and Secretary (principal financial officer and principal accounting officer) |
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10-Q EXHIBIT INDEX
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Exhibit No. |
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Description |
10.19
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Consulting Agreement, dated as of October 3, 2007 (filed as an exhibit to the
Companys Current Report on Form 8-K on October 9, 2007 and incorporated herein by
reference) |
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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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