UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2004
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 000-32883
WRIGHT MEDICAL GROUP, INC.
| Delaware (State or other jurisdiction of incorporation or organization) |
13-4088127 (IRS employer identification number) |
|
| 5677 Airline Road | ||
| Arlington, Tennessee (Address of principal executive offices) |
38002 (Zip code) |
|
| Registrants telephone number, including area code: |
(901) 867-9971 |
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. x Yes o No
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). x Yes o No
As of April 28, 2004, there were 33,242,730 shares of common stock outstanding.
WRIGHT MEDICAL GROUP, INC.
TABLE OF CONTENTS
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SAFE-HARBOR STATEMENT
This quarterly report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this quarterly report, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect managements current knowledge, assumptions, beliefs, estimates, and expectations and express managements current views of future performance, results, and trends. We wish to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in our filings with the Securities and Exchange Commission (including those described in Item 7 of our annual report on Form 10-K for the year ended December 31, 2003, under the heading, Factors Affecting Future Operating Results, and in this quarterly report) which could cause our actual results to materially differ from those described in the forward-looking statements. Although we believe that the forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A forward-looking statement should not be regarded as a representation by us that the results described therein will be achieved. We wish to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of the date of this quarterly report. We assume no obligation to update any forward-looking statement after this date.
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
WRIGHT MEDICAL GROUP, INC.
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
| (unaudited) | ||||||||
Assets: |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 71,016 | $ | 66,571 | ||||
Accounts receivable, net |
60,259 | 55,821 | ||||||
Inventories |
67,479 | 64,204 | ||||||
Prepaid expenses |
4,568 | 5,046 | ||||||
Deferred income taxes |
13,528 | 15,591 | ||||||
Other current assets |
3,783 | 3,291 | ||||||
Total current assets |
220,633 | 210,524 | ||||||
Property, plant and equipment, net |
67,008 | 66,915 | ||||||
Goodwill |
8,676 | 11,248 | ||||||
Intangible assets, net |
17,642 | 18,646 | ||||||
Deferred income taxes |
13,899 | 13,398 | ||||||
Other assets |
1,569 | 1,372 | ||||||
| $ | 329,427 | $ | 322,103 | |||||
Liabilities and Stockholders Equity: |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 16,967 | $ | 14,227 | ||||
Accrued expenses and other current liabilities |
42,450 | 42,814 | ||||||
Current portion of long-term obligations |
5,984 | 6,228 | ||||||
Total current liabilities |
65,401 | 63,269 | ||||||
Long-term obligations |
10,955 | 11,096 | ||||||
Deferred income taxes |
1,552 | 1,203 | ||||||
Other liabilities |
5,707 | 8,217 | ||||||
Total liabilities |
83,615 | 83,785 | ||||||
Commitments and contingencies (Note 8) |
||||||||
Stockholders equity: |
||||||||
Common stock, voting, $.01 par value, shares
authorized 70,000,000; shares issued and
outstanding 33,115,438 in 2004, 33,040,747 in 2003 |
332 | 330 | ||||||
Additional paid-in capital |
264,837 | 263,455 | ||||||
Deferred compensation |
(1,104 | ) | (1,452 | ) | ||||
Accumulated other comprehensive income |
14,823 | 15,675 | ||||||
Accumulated deficit |
(33,076 | ) | (39,690 | ) | ||||
Total stockholders equity |
245,812 | 238,318 | ||||||
| $ | 329,427 | $ | 322,103 | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
WRIGHT MEDICAL GROUP, INC.
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Net sales |
$ | 74,917 | $ | 58,622 | ||||
Cost of sales |
20,386 | 15,540 | ||||||
Gross profit |
54,531 | 43,082 | ||||||
Operating expenses: |
||||||||
Selling, general and administrative |
37,134 | 30,305 | ||||||
Research and development |
4,982 | 3,535 | ||||||
Amortization of intangible assets |
942 | 804 | ||||||
Stock-based expense |
424 | 409 | ||||||
Acquired in-process research and development costs
(Note 2) |
| 4,558 | ||||||
Total operating expenses |
43,482 | 39,611 | ||||||
Operating income |
11,049 | 3,471 | ||||||
Interest expense, net |
284 | 266 | ||||||
Other expense (income), net |
38 | (30 | ) | |||||
Income before income taxes |
10,727 | 3,235 | ||||||
Provision for income taxes |
4,113 | 1,234 | ||||||
Net income |
$ | 6,614 | $ | 2,001 | ||||
Net income per share (Note 6): |
||||||||
Basic |
$ | 0.20 | $ | .06 | ||||
Diluted |
$ | 0.19 | $ | .06 | ||||
Weighted-average number of shares outstanding-basic |
33,077 | 32,715 | ||||||
Weighted-average number of shares outstanding-diluted |
35,241 | 34,059 | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
WRIGHT MEDICAL GROUP, INC.
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Operating activities: |
||||||||
Net income |
$ | 6,614 | $ | 2,001 | ||||
Non-cash items included in net income: |
||||||||
Depreciation |
4,067 | 3,463 | ||||||
Amortization of intangible assets |
942 | 804 | ||||||
Amortization of deferred financing costs |
65 | 65 | ||||||
Deferred income taxes |
2,355 | 752 | ||||||
Stock-based expense |
424 | 409 | ||||||
Acquired in-process research and development costs |
| 4,558 | ||||||
Other |
(85 | ) | 267 | |||||
Changes in operating assets and liabilities, net of
acquisitions: |
||||||||
Accounts receivable |
(4,649 | ) | (4,110 | ) | ||||
Inventories |
(3,564 | ) | (833 | ) | ||||
Other current assets |
(551 | ) | 295 | |||||
Accounts payable |
2,919 | 47 | ||||||
Accrued expenses and other liabilities |
(1,664 | ) | 380 | |||||
Net cash provided by operating activities |
6,873 | 8,098 | ||||||
Investing activities: |
||||||||
Capital expenditures |
(4,424 | ) | (2,995 | ) | ||||
Purchase of tangible and intangible assets (Note 2) |
(161 | ) | (3,405 | ) | ||||
Other |
3 | 50 | ||||||
Net cash used in investing activities |
(4,582 | ) | (6,350 | ) | ||||
Financing activities: |
||||||||
Proceeds from bank and other financing |
1,910 | | ||||||
Payments of bank and other financing |
(508 | ) | (430 | ) | ||||
Issuance of common stock |
808 | 45 | ||||||
Net cash provided by (used in) financing activities |
2,210 | (385 | ) | |||||
Effect of exchange rates on cash and cash equivalents |
(56 | ) | 105 | |||||
Net increase in cash and cash equivalents |
$ | 4,445 | $ | 1,468 | ||||
Cash and cash equivalents, beginning of period |
$ | 66,571 | $ | 51,373 | ||||
Cash and cash equivalents, end of period |
$ | 71,016 | $ | 52,841 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
WRIGHT MEDICAL GROUP, INC.
| 1. | Summary of Significant Accounting Policies |
Basis of Presentation. The unaudited condensed consolidated interim financial statements of Wright Medical Group, Inc. (the Company) have been prepared in accordance with accounting principles generally accepted in the United States (U.S.) for interim financial information and the instructions to Quarterly Report on Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed, or omitted, pursuant to these rules and regulations. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Companys consolidated financial statements and related notes included in the Companys annual report on Form 10-K for the year ended December 31, 2003, as filed with the Securities and Exchange Commission (SEC).
In the opinion of management, these statements reflect all adjustments necessary for a fair presentation of the interim financial statements. All such adjustments are of a normal and recurring nature. The results of operations for any interim period are not necessarily indicative of results for the full fiscal year.
The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned domestic and international subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.
Stock Based Compensation. As of March 31, 2004, the Company has two stock-based employee compensation plans. The Company accounts for those plans under the intrinsic value method in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees. Accordingly, compensation cost related to stock option grants to employees has been recognized only to the extent that the fair market value of the stock exceeds the exercise price of the stock option at the date of grant. Nonemployee stock-based compensation is accounted for in accordance with Statement of Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation.
The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation (in thousands, except per share amounts):
| Three Months Ended March 31, |
||||||||
| 2004 |
2003 |
|||||||
Net income, as reported |
$ | 6,614 | $ | 2,001 | ||||
Add: Stock-based employee compensation
cost recognized under intrinsic value
method, net of tax |
208 | 230 | ||||||
Less: Stock-based employee compensation
expense determined under fair value
based method, net of tax |
(1,819 | ) | (928 | ) | ||||
Pro forma net income |
$ | 5,003 | $ | 1,303 | ||||
Income per share: |
||||||||
Basic, as reported |
$ | 0.20 | $ | 0.06 | ||||
Basic, pro forma |
$ | 0.15 | $ | 0.04 | ||||
Diluted, as reported |
$ | 0.19 | $ | 0.06 | ||||
Diluted, pro forma |
$ | 0.14 | $ | 0.04 | ||||
Amounts presented in stock-based expense include selling, general and administrative expenses of $398,000 and $383,000 for the three month periods ended March 31, 2004 and 2003, respectively, and research and development expenses of $26,000 for the three month periods ended March 31, 2004 and 2003.
4
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
| 2. | Acquisition of Assets |
On March 5, 2003, the Company completed an acquisition of certain assets from Gliatech Inc. related to its ADCON® Gel technology for $8.4 million in cash and a royalty contingent upon future product sales. The Company paid $840,000 of the purchase price as a deposit in the fourth quarter of 2002, and $3.4 million in the first quarter of 2003. The remaining $4.2 million was paid in the second quarter of 2003 upon final receipt of all assets. The following table summarizes the allocation of the purchase price (in thousands):
Inventories |
$ | 1,312 | ||
Property, plant and equipment |
160 | |||
Acquired in-process research and development |
4,558 | |||
Intangible assets: |
||||
Completed technology |
1,575 | |||
Trademarks |
554 | |||
Other |
286 | |||
| $ | 8,445 | |||
In connection with the acquisition of these assets, the Company engaged an independent third party to conduct a valuation of the intangible assets acquired. The value assigned to acquired in-process research and development (IPRD) was $4.6 million of the purchase price. Accordingly, this amount was expensed in the three-month period ended March 31, 2003. The value assigned to IPRD was determined by estimating the costs to develop the IPRD into commercially viable products, estimating the resulting cash flows from such projects, and discounting the net cash flows back to their present value. The discount rate applied in the valuation reflected uncertainties surrounding the successful development of the IPRD.
| 3. | Inventories |
Inventories consist of the following (in thousands):
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
Raw materials |
$ | 2,384 | $ | 2,816 | ||||
Work-in-process |
12,153 | 9,827 | ||||||
Finished goods |
52,942 | 51,561 | ||||||
| $ | 67,479 | $ | 64,204 | |||||
| 4. | Long-Term Obligations |
Long-term obligations consist of the following (in thousands):
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
Notes payable |
$ | 13,250 | $ | 13,250 | ||||
Capital lease obligations |
3,689 | 4,074 | ||||||
| 16,939 | 17,324 | |||||||
Less: current portion |
(5,984 | ) | (6,228 | ) | ||||
| $ | 10,955 | $ | 11,096 | |||||
At March 31, 2004, the Companys senior credit facility consisted of $13.3 million in outstanding term loan borrowings and availability under a revolving credit facility, after considering outstanding letters of credit, totaling $57.7 million. At the Companys option, borrowings under the credit facility bear interest either at a rate equal to a fixed base rate plus a spread of .75% to 1.25% or at a rate equal to an adjusted LIBOR plus a spread of 1.75% to 2.25%, depending on the Companys consolidated leverage ratio, with a rate of 2.9% at March 31, 2004.
5
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
| 5. | Goodwill and Intangible Assets |
Changes in the carrying amount of goodwill during the three months ended March 31, 2004 are as follows (in thousands):
Goodwill, net of accumulated amortization at December 31, 2003 |
$ | 11,248 | ||
Less: Resolution of pre-acquisition foreign income tax contingency |
(2,344 | ) | ||
Foreign currency translation |
(228 | ) | ||
Goodwill at March 31, 2004 |
$ | 8,676 | ||
During the period ended March 31, 2004, the Company favorably resolved a foreign income tax contingency associated with its December 1999 acquisition of Cremascoli Ortho Holding, S.A. (Cremascoli). This amount was provided for in the purchase accounting in connection with the acquisition of Cremascoli, and due to the favorable resolution of this matter, the Company reduced the previously recorded goodwill and the associated contingency accrual, which was recorded in Other Long-Term Liabilities in the Companys condensed consolidated balance sheet.
The components of the Companys identifiable intangible assets are as follows (in thousands):
| March 31, 2004 |
December 31, 2003 |
|||||||||||||||
| Accumulated | Accumulated | |||||||||||||||
| Cost |
amortization |
Cost |
amortization |
|||||||||||||
Completed technology |
$ | 5,271 | $ | 1,187 | $ | 5,288 | $ | 1,025 | ||||||||
Distribution channels |
18,877 | 8,013 | 19,296 | 7,708 | ||||||||||||
Trademarks |
657 | 95 | 657 | 75 | ||||||||||||
Other |
4,557 | 2,425 | 4,345 | 2,132 | ||||||||||||
| 29,362 | $ | 11,720 | 29,586 | $ | 10,940 | |||||||||||
Less: Accumulated amortization |
(11,720 | ) | (10,940 | ) | ||||||||||||
Intangible assets, net |
$ | 17,642 | $ | 18,646 | ||||||||||||
Based on the intangible assets held at March 31, 2004, the Company expects to recognize amortization expense of approximately $3.5 million for the full year of 2004, $3.2 million in 2005 and 2006, $2.8 million in 2007, and $2.7 million in 2008.
| 6. | Earnings Per Share |
SFAS No. 128, Earnings Per Share, requires the presentation of basic and diluted earnings per share. Basic earnings per share is calculated based on the weighted-average shares of common stock outstanding during the period. Diluted earnings per share is calculated to include any dilutive effect of the Companys common stock equivalents. The Companys common stock equivalents consist of stock options and warrants. The dilutive effect of such instruments is calculated using the treasury-stock method.
The weighted-average number of common shares outstanding for basic and diluted earnings per share is as follows (in thousands):
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Weighted-average number of shares
outstanding, basic |
33,077 | 32,715 | ||||||
Common stock equivalents |
2,164 | 1,344 | ||||||
Weighted-average number of shares
outstanding, diluted |
35,241 | 34,059 | ||||||
6
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
| 7. | Other Comprehensive Income |
The Companys difference between net income and comprehensive income is wholly attributable to foreign currency translation. The following table provides a reconciliation of net income to comprehensive income (in thousands):
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Net income |
$ | 6,614 | $ | 2,001 | ||||
Changes in foreign currency translation |
(852 | ) | 1,903 | |||||
Comprehensive income |
$ | 5,762 | $ | 3,904 | ||||
| 8. | Commitments and Contingencies |
Legal Proceedings. On June 30, 1993, prior to the December 1999 recapitalization and inception of the Company in its current form, the Companys predecessor company, Wright Medical Technology, Inc. (the Predecessor Company), acquired substantially all the assets of the large joint orthopaedic implant business from Dow Corning Corporation (DCC). DCC retains liability for matters arising from certain conduct of DCC prior to June 30, 1993. As such, DCC has agreed to indemnify the Predecessor Company against all liability for all products manufactured prior to the acquisition except for products provided under the Predecessor Companys 1993 agreement with DCC pursuant to which the Predecessor Company purchased certain small joint orthopaedic implants for worldwide distribution. The Predecessor Company was notified in May 1995 that DCC, which filed for reorganization under Chapter 11 of the U.S. Bankruptcy Code, would no longer defend the Predecessor Company in such matters until it received further direction from the bankruptcy court. Based on the most recent plan of reorganization submitted to the court, it appears that the Predecessor Company would be considered an unsecured creditor and, under the terms of the plan, would receive 24% of any such claim as a cash payment with the remainder to be paid by a senior note due within ten years. There are several appeals regarding the confirmed plan of reorganization pending before the U.S. District Court in Detroit, Michigan, which have delayed implementation of the plan. There can be no assurance that DCC will indemnify the Predecessor Company or the Company on any claims in the future. Although neither the Predecessor Company nor the Company maintains insurance for claims arising on products sold by DCC, the Company does not believe the outcome of any of these matters will have a material adverse effect on the Companys financial position or results of operations.
In March 2000, Howmedica Osteonics Corp. served a lawsuit against the Company alleging patent infringement. The lawsuit seeks an order of infringement, injunctive relief, unspecified damages and various other costs and relief. The claims could impact a substantial portion of our knee product line. The Company believes it has strong defenses against this claim and intends to vigorously defend this lawsuit. The Company also believes this claim is, in part, covered pursuant to the Companys patent infringement insurance. Management does not believe that the outcome of this claim will have a material adverse effect on the Companys financial position or results of operations.
In July 2002, the Company entered into a license agreement to resolve an intellectual property dispute that, among other things, provided for a payment of up to $1.25 million if a particular patent re-issued by February 10, 2004, and certain other conditions, as defined in the license agreement, were satisfied. While the patent in question re-issued prior to February 10, 2004, management believes that the other required conditions were not satisfied upon re-issuance and the consequential payment of any amount is not probable. Accordingly, no provision has been made for this contingency as of March 31, 2004.
In July 2002, pursuant to a purchase and royalty agreement with CERAbio LLC (CERAbio), the Company purchased assets consisting primarily of completed technology for $3.0 million, and recorded this entire amount as an intangible asset. Of this purchase price, $1.5 million was paid upon signing the purchase agreement. The remaining $1.5 million is provided for in accrued expenses and is due once certain conditions under the agreement are satisfied. The agreement also provides for specified future royalties contingent upon sales of products related to the acquired technology. The Company, believing that the contractual obligations for payment had not been met, disputed whether the second payment and royalties had been earned. In 2003, CERAbio and Phillips Plastics Corporation filed a lawsuit in United States District Court for the Western District of Wisconsin against the
7
WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Company for payment of the additional $1.5 million purchase price and the royalties earned to date. During the fourth quarter of 2003, a jury returned a verdict in favor of CERAbio and ordered the Company to pay the remaining purchase price and the royalties earned to date. The royalties earned to date have been recorded within Accrued Expenses and Other Current Liabilities in our consolidated balance sheet. The Company has appealed the verdict to the United States Court of Appeals for the Seventh Circuit and the appeal is pending. The Company intends to vigorously defend its position in this case and, in the opinion of management, does not believe that this claim will have a material adverse affect on its financial position or results of operations.
The Company is subject to various legal proceedings, product liability claims and other matters which arise in the ordinary course of business. In the opinion of management, the amount of liability, if any, with respect to these matters will not materially affect the results of operations or financial position of the Company.
Regulatory. In March 2004, the Company received marketing clearance from the United States Food and Drug Administration (FDA) for its ALLOMATRIX® Injectable Putty. This clearance was obtained based on satisfaction of the FDAs requirements pursuant to a 510(k) premarket notification process that began with the Companys submission of a 510(k) in March 2002. This submission was in response to the FDAs clarification to all allograft putty providers, including the Company, that such products are regulated under the medical device premarket notification provisions of the Food, Drug, and Cosmetic Act (the Act). The Companys clearance pertains only to its ALLOMATRIX® Injectable Putty product and the Company continues to market and sell other allograft products pending approval of additional 510(k) submissions. The FDA indicated that it would exercise enforcement discretion for a reasonable period of time while companies bring their devices into compliance with the Act. The FDA has not raised any objection to the continued marketing and sale of the Companys additional ALLOMATRIX® products pending the approval of premarket notification submissions. There can be no assurance that the 510(k) premarket notifications for the remaining products will be cleared by the FDA in a timely manner or at all. The FDA could decide not to continue to exercise its enforcement discretion and decide to take enforcement action which could include, but not be limited to, seizing product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. However, the Company believes that such punitive actions by the FDA against the Company are unlikely. In 2003, 2002 and 2001, ALLOMATRIX® products other than our ALLOMATRIX® Injectable Putty represented approximately 6%, 6% and 2% of the Companys total net sales, respectively.
8
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
General
The following managements discussion and analysis describes the principal factors affecting our results of operations and our financial condition for the quarter ended March 31, 2004. This discussion should be read in conjunction with the accompanying unaudited financial statements and our annual report on Form 10-K for the year ended December 31, 2003 (Annual Report), which includes additional information about our critical accounting policies and practices and factors affecting future operating results.
Executive Overview
Company Description. Wright Medical Group, Inc. is a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics products. Reconstructive joint devices are used to replace knee, hip and other joints that have deteriorated through disease or injury. Biologics are used to replace damaged or diseased bone, to stimulate bone growth, and to provide other biological solutions for surgeons and their patients. We have been in business for over fifty years and have built a well-known and respected brand name and strong relationships with orthopaedic surgeons.
Principal Products. Our net sales primarily include sales of reconstructive joint devices and biologics products. Our reconstructive joint device net sales are derived from three primary product lines: knees, hips and extremities. Our biologics sales encompass sales of products designed to stimulate and augment the natural regenerative capabilities of the human body. Additionally, we generate other net sales from various orthopaedic products not considered to be part of our knee, hip, extremity or biologics product lines.
Significant Business Trends. During the first quarter of 2004, our business sustained the trend we established in 2003, growing significantly as compared to the first quarter of 2003. Net sales totaled $74.9 million in the first quarter of 2004, compared to $58.6 million in the first quarter of 2003, representing growth of 28%. Our first quarter sales performance was driven primarily by our biologics, extremity and hip product lines as well as favorable foreign currency exchange rates as compared to prior year. Our biologics and extremity product lines, which have been the historical growth drivers of our business, experienced sales growth rates of 29% and 25%, respectively. Additionally, our hip business grew 41% over the first quarter of 2003, continuing to benefit from several products that were successfully introduced in 2003.
In March 2004, we received marketing clearance from the United States Food and Drug Administration (FDA) for our ALLOMATRIX® Injectable Putty. This clearance was obtained based on satisfaction of the FDAs requirements pursuant to a 510(k) premarket notification process that began with our submission of a 510(k) in March 2002. This submission was in response to the FDAs clarification to all allograft putty providers, including us, that such products should be regulated under the medical device premarket notification provisions of the Food, Drug, and Cosmetic Act (the Act). The clearance pertained only to our ALLOMATRIX® Injectable Putty product and we continue to market and sell other allograft-based products pending approval of additional 510(k) submissions. The FDA indicated that it would exercise enforcement discretion for a reasonable period of time while companies bring their devices into compliance with the Act and has not raised any objection to the continued marketing and sale of our additional ALLOMATRIX® products pending the approval of premarket notification submissions. See Factors Affecting Future Operating Results for a detailed discussion of this regulatory development.
In March 2004, our premarket approval (PMA) application for our CONSERVE® Plus Resurfacing Implant was accepted for filing by the FDA. With our CONSERVE® Plus Resurfacing Implant, the surface of the patients femoral head and the acetabular surface are replaced with minimal bone loss.
In February 2004, our PMA application for our ADCON® Gel product was accepted for filing by the FDA. We are currently awaiting the FDAs review and response to this submission. Our ADCON® Gel product is currently not available in the United States (U.S.) market.
Our performance outlook anticipates that our business will continue to grow across all product lines for the remainder of 2004. Our diverse and continually expanding biologics and extremity product portfolios, combined with our full-continuum of successful hip and knees products, positions us well for continued success throughout 2004.
9
Significant Industry Factors. Our industry is impacted by numerous competitive, regulatory and other significant factors. The growth of our business relies on our ability to continue to develop new products and innovative technologies, obtain regulatory clearance and compliance for our products, protect the proprietary technology of our products and our manufacturing processes, manufacture our products cost-effectively, and successfully market and distribute our products in a profitable manner. We, and the entire industry, are subject to extensive government regulation, primarily by the FDA. Failure to comply with regulatory requirements could have a material adverse effect on our business. Additionally, our industry is highly competitive and our success is dependent on our ability to compete successfully against our competitors. We devote significant resources to assessing and analyzing competitive, regulatory and economic risks and opportunities. A detailed discussion of these and other factors is provided in the Factors Affecting Future Operating Results section of our Managements Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report.
Results of Operations
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts (in thousands) and as percentages of net sales:
| Three Months Ended March 31, | ||||||||||||||||
| (unaudited) |
||||||||||||||||
| 2004 |
2003 |
|||||||||||||||
| Amount |
% of sales |
Amount |
% of sales |
|||||||||||||
Net sales |
$ | 74,917 | 100.0 | % | $ | 58,622 | 100.0 | % | ||||||||
Cost of sales |
20,386 | 27.2 | % | 15,540 | 26.5 | % | ||||||||||
Gross profit |
54,531 | 72.8 | % | 43,082 | 73.5 | % | ||||||||||
Operating expenses: |
||||||||||||||||
Selling, general and administrative |
37,134 | 49.6 | % | 30,305 | 51.7 | % | ||||||||||
Research and development |
4,982 | 6.7 | % | 3,535 | 6.0 | % | ||||||||||
Amortization of intangible assets |
942 | 1.3 | % | 804 | 1.4 | % | ||||||||||
Stock-based expense |
424 | 0.6 | % | 409 | 0.7 | % | ||||||||||
Acquired in-process research and
development costs |
| | 4,558 | 7.8 | % | |||||||||||
Total operating expenses |
43,482 | 58.0 | % | 39,611 | 67.6 | % | ||||||||||
Operating income |
11,049 | 14.7 | % | 3,471 | 5.9 | % | ||||||||||
Interest expense, net |
284 | 0.4 | % | 266 | 0.5 | % | ||||||||||
Other expense (income), net |
38 | 0.1 | % | (30 | ) | (0.1 | %) | |||||||||
Income before income taxes |
10,727 | 14.3 | % | 3,235 | 5.5 | % | ||||||||||
Provision for income taxes |
4,113 | 5.5 | % | 1,234 | 2.1 | % | ||||||||||
Net income |
$ | 6,614 | 8.8 | |||||||||||||