UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
ý |
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2003 |
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or |
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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 0-14680
GENZYME CORPORATION
(Exact name of registrant as specified in its charter)
Massachusetts (State or other jurisdiction of incorporation or organization) |
06-1047163 (I.R.S. Employer Identification No.) |
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One Kendall Square, Cambridge, Massachusetts (Address of principal executive offices) |
02139 (zip code) |
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(617) 252-7500 (Registrant's telephone number, including area code) |
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. Yes ý No o
Indicate by check mark whether the Registrant is an accelerated filer (as defined by Rule 12b-2 of the Exchange Act). Yes ý No o
The number of shares outstanding of the issuer's common stock as of July 31, 2003:
Genzyme General Division Common Stock | 222,063,153 |
NOTE REGARDING REFERENCES TO GENZYME DIVISIONS AND SERIES OF STOCK
Throughout this Form 10-Q, the words "we," "us," "our" and "Genzyme" refer to Genzyme Corporation and all of its operating divisions taken as a whole, and "our board of directors" refers to the board of directors of Genzyme Corporation. In addition, we refer to our three operating divisions as follows:
Through June 30, 2003, we had three outstanding series of common stock. Each series was designed to reflect the value and track the performance of one of our divisions. We refer to each series of common stock as follows:
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock, were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery and Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and management's discussion and analysis for each of our divisions but will continue to provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Form 10-Q contains forward-looking statements, including statements regarding our:
These statements are subject to risks and uncertainties, and our actual results may differ significantly from those that are described in this report. These risks and uncertainties include:
We have included more detailed descriptions of these risks and uncertainties in Item 2 of this report under the heading "Factors Affecting Future Operating Results." We encourage you to read those descriptions carefully. We caution investors not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated) and we undertake no obligation to update or revise the statements.
NOTE REGARDING INCORPORATION BY REFERENCE
The Securities and Exchange Commission allows us to disclose important information to you by referring you to other documents we have filed with the SEC. The information that we refer you to is "incorporated by reference" into this Form 10-Q. Please read that information.
NOTE REGARDING TRADEMARKS
Genzyme®, Cerezyme®, Fabrazyme®, Thyrogen®, Renagel®, Seprafilm®, Sepragel®, Carticel®, Epicel®, Synvisc® and Hylaform® are registered trademarks of Genzyme. Myozyme, SAGE and Sepra are trademarks of Genzyme. FocalSeal® is a registered trademark of Focal, Inc. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. WelChol® is a registered trademark of Sankyo Pharma, Inc. Snowden-Pencer® is a registered trademark of Snowden-Pencer, Inc. Zavesca® is a trademark of Celltech Group plc. All rights reserved.
GENZYME CORPORATION AND SUBSIDIARIES
FORM 10-Q, JUNE 30, 2003
TABLE OF CONTENTS
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PAGE NO. |
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PART I. | FINANCIAL INFORMATION | 1 | |||
ITEM 1. |
Financial Statements |
1 |
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GENZYME CORPORATION AND SUBSIDIARIES |
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Unaudited, Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2003 and 2002 | 1 | ||||
Unaudited, Consolidated Balance Sheets as of June 30, 2003 and December 31, 2002 | 3 | ||||
Unaudited, Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002 | 4 | ||||
Notes to Unaudited, Consolidated Financial Statements | 5 | ||||
GENZYME GENERAL |
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Unaudited, Combined Statements of Operations for the Three and Six Months Ended June 30, 2003 and 2002 | 24 | ||||
Unaudited, Combined Balance Sheets as of June 30, 2003 and December 31, 2002 | 25 | ||||
Unaudited, Combined Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002 | 26 | ||||
Notes to Unaudited, Combined Financial Statements | 27 | ||||
GENZYME BIOSURGERY |
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Unaudited, Combined Statements of Operations for the Three and Six Months Ended June 30, 2003 and 2002 | 36 | ||||
Unaudited, Combined Balance Sheets as of June 30, 2003 and December 31, 2002 | 37 | ||||
Unaudited, Combined Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002 | 38 | ||||
Notes to Unaudited, Combined Financial Statements | 39 | ||||
GENZYME MOLECULAR ONCOLOGY |
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Unaudited, Combined Statements of Operations for the Three and Six Months Ended June 30, 2003 and 2002 | 46 | ||||
Unaudited, Combined Balance Sheets as of June 30, 2003 and December 31, 2002 | 47 | ||||
Unaudited, Combined Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002 | 48 | ||||
Notes to Unaudited, Combined Financial Statements | 49 | ||||
ITEM 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
52 |
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ITEM 3. |
Quantitative and Qualitative Disclosures About Market Risk |
119 |
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ITEM 4. |
Controls and Procedures |
119 |
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PART II. |
OTHER INFORMATION |
120 |
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ITEM 1. |
Legal Proceedings |
120 |
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ITEM 2. |
Changes in Securities |
121 |
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ITEM 4. |
Submission of Matters to a Vote of Security Holders |
121 |
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ITEM 6. |
Exhibits and Reports on Form 8-K |
123 |
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Signatures |
124 |
i
GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(Unaudited, amounts in thousands)
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2003 |
2002 |
2003 |
2002 |
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Revenues: | ||||||||||||||||
Net product sales | $ | 383,232 | $ | 299,980 | $ | 729,721 | $ | 566,606 | ||||||||
Net service sales | 31,550 | 28,024 | 63,048 | 54,707 | ||||||||||||
Revenues from research and development contracts: | ||||||||||||||||
Related parties | 684 | 784 | 1,122 | 1,396 | ||||||||||||
Other | 3,437 | 3,404 | 6,871 | 7,423 | ||||||||||||
Total revenues | 418,903 | 332,192 | 800,762 | 630,132 | ||||||||||||
Operating costs and expenses: |
||||||||||||||||
Cost of products sold | 100,306 | 76,522 | 195,140 | 148,676 | ||||||||||||
Cost of services sold | 19,271 | 16,439 | 36,249 | 31,457 | ||||||||||||
Selling, general and administrative | 130,807 | 110,882 | 245,031 | 213,840 | ||||||||||||
Research and development (including research and development related to contracts) | 79,063 | 75,934 | 154,694 | 158,075 | ||||||||||||
Amortization of intangibles | 17,641 | 17,586 | 35,146 | 35,183 | ||||||||||||
Charge for impairment of goodwill | 102,792 | | 102,792 | | ||||||||||||
Charge for impaired asset | 2,898 | | 2,898 | | ||||||||||||
Total operating costs and expenses | 452,778 | 297,363 | 771,950 | 587,231 | ||||||||||||
Operating income (loss) | (33,875 | ) | 34,829 | 28,812 | 42,901 | |||||||||||
Other income (expenses): |
||||||||||||||||
Equity in net loss of unconsolidated affiliates | (4,804 | ) | (3,948 | ) | (8,998 | ) | (8,042 | ) | ||||||||
Gain (loss) on investments in equity securities | (3,620 | ) | 343 | (3,620 | ) | 509 | ||||||||||
Loss on sale of product line | (29,367 | ) | | (29,367 | ) | | ||||||||||
Other | 769 | 1,827 | 1,519 | 963 | ||||||||||||
Investment income | 12,428 | 12,624 | 24,042 | 26,061 | ||||||||||||
Interest expense | (6,335 | ) | (7,059 | ) | (12,825 | ) | (13,865 | ) | ||||||||
Total other income (expenses) | (30,929 | ) | 3,787 | (29,249 | ) | 5,626 | ||||||||||
Income (loss) before income taxes | (64,804 | ) | 38,616 | (437 | ) | 48,527 | ||||||||||
Provision for income taxes | (9,726 | ) | (10,293 | ) | (28,724 | ) | (13,431 | ) | ||||||||
Net income (loss) before cumulative effect of change in accounting for goodwill | (74,530 | ) | 28,323 | (29,161 | ) | 35,096 | ||||||||||
Cumulative effect of change in accounting for goodwill | | | | (98,270 | ) | |||||||||||
Net income (loss) | $ | (74,530 | ) | $ | 28,323 | $ | (29,161 | ) | $ | (63,174 | ) | |||||
Comprehensive income (loss), net of tax: |
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Net income (loss) | $ | (74,530 | ) | $ | 28,323 | $ | (29,161 | ) | $ | (63,174 | ) | |||||
Other comprehensive income (loss), net of tax: | ||||||||||||||||
Foreign currency translation adjustments | 44,120 | 47,999 | 58,894 | 38,799 | ||||||||||||
Gain on affiliate sale of stock, net of tax | | | 2,856 | | ||||||||||||
Unrealized gains (losses) on securities: | ||||||||||||||||
Unrealized gains (losses) arising during the period | 7,534 | (2,752 | ) | 11,533 | (26,709 | ) | ||||||||||
Reclassification adjustment for losses included in net income (loss) | 2,288 | 81 | 2,288 | 81 | ||||||||||||
Unrealized gains (losses) on securities, net of tax | 9,822 | (2,671 | ) | 13,821 | (26,628 | ) | ||||||||||
Other | (146 | ) | (541 | ) | (77 | ) | (163 | ) | ||||||||
Other comprehensive income (loss) | 53,796 | 44,787 | 75,494 | 12,008 | ||||||||||||
Comprehensive income (loss) | $ | (20,734 | ) | $ | 73,110 | $ | 46,333 | $ | (51,166 | ) | ||||||
The accompanying notes are an integral part of these unaudited, consolidated financial statements.
1
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2003 |
2002 |
2003 |
2002 |
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Net income (loss) per share: | |||||||||||||||
Allocated to Genzyme General Stock: | |||||||||||||||
Genzyme General division net income | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | |||||||
Tax benefit allocated from Genzyme Biosurgery | 6,398 | 2,994 | 8,720 | 7,293 | |||||||||||
Tax benefit allocated from Genzyme Molecular Oncology | 1,657 | 2,235 | 3,420 | 4,365 | |||||||||||
Net income allocated to Genzyme General Stock | $ | 70,836 | $ | 49,640 | $ | 132,714 | $ | 80,378 | |||||||
Net income per share of Genzyme General Stock: |
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Basic | $ | 0.33 | $ | 0.23 | $ | 0.62 | $ | 0.38 | |||||||
Diluted | $ | 0.32 | $ | 0.23 | $ | 0.60 | $ | 0.36 | |||||||
Weighted average shares outstanding: |
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Basic | 216,313 | 213,917 | 215,702 | 213,624 | |||||||||||
Diluted | 222,867 | 219,634 | 221,650 | 220,349 | |||||||||||
Allocated to Biosurgery Stock: |
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Genzyme Biosurgery division net loss before cumulative effect of change in accounting for goodwill | $ | (152,554 | ) | $ | (17,522 | ) | $ | (166,656 | ) | $ | (37,904 | ) | |||
Cumulative effect of change in accounting for goodwill | | | | (98,270 | ) | ||||||||||
Genzyme Biosurgery division net loss | (152,554 | ) | (17,522 | ) | (166,656 | ) | (136,174 | ) | |||||||
Allocated tax benefit | 11,597 | 2,442 | 14,005 | 4,890 | |||||||||||
Net loss allocated to Biosurgery Stock | $ | (140,957 | ) | $ | (15,080 | ) | $ | (152,651 | ) | $ | (131,284 | ) | |||
Net loss per share of Biosurgery Stockbasic and diluted: |
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Net loss per share before cumulative effect of change in accounting for goodwill | $ | (3.46 | ) | $ | (0.38 | ) | $ | (3.76 | ) | $ | (0.83 | ) | |||
Per share cumulative effect of change in accounting for goodwill | | | | (2.48 | ) | ||||||||||
Net loss per share of Biosurgery Stockbasic and diluted | $ | (3.46 | ) | $ | (0.38 | ) | $ | (3.76 | ) | $ | (3.31 | ) | |||
Weighted average shares outstanding |
40,681 |
39,637 |
40,630 |
39,600 |
|||||||||||
Allocated to Molecular Oncology Stock: |
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Genzyme Molecular Oncology division net loss | $ | (4,409 | ) | $ | (6,237 | ) | $ | (9,224 | ) | $ | (12,268 | ) | |||
Net loss per share of Molecular Oncology Stockbasic and diluted | $ | (0.26 | ) | $ | (0.37 | ) | $ | (0.54 | ) | $ | (0.73 | ) | |||
Weighted average shares outstanding |
16,978 |
16,801 |
16,958 |
16,782 |
|||||||||||
The accompanying notes are an integral part of these unaudited, consolidated financial statements.
2
GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(Unaudited, amounts in thousands, except par value amounts)
|
June 30, 2003 |
December 31, 2002 |
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ASSETS | |||||||||
Current assets: |
|||||||||
Cash and cash equivalents | $ | 342,630 | $ | 406,811 | |||||
Short-term investments | 246,183 | 105,992 | |||||||
Accounts receivable, net | 316,326 | 287,141 | |||||||
Inventories | 210,725 | 238,809 | |||||||
Prepaid expenses and other current assets | 53,795 | 45,187 | |||||||
Due from Teleflex Incorporated | 32,767 | | |||||||
Deferred tax assets | 106,065 | 105,094 | |||||||
Total current assets | 1,308,491 | 1,189,034 | |||||||
Property, plant and equipment, net |
882,609 |
802,448 |
|||||||
Long-term investments | 702,910 | 682,201 | |||||||
Notes receivablerelated parties | 12,131 | 11,918 | |||||||
Goodwill, net | 489,313 | 592,075 | |||||||
Other intangible assets, net | 678,309 | 734,478 | |||||||
Investments in equity securities | 69,197 | 42,945 | |||||||
Other noncurrent assets | 36,062 | 27,950 | |||||||
Total assets | $ | 4,179,022 | $ | 4,083,049 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: | |||||||||
Accounts payable | $ | 37,478 | $ | 44,458 | |||||
Accrued expenses | 196,062 | 190,754 | |||||||
Income taxes payable | 71,351 | 61,964 | |||||||
Deferred revenue | 13,185 | 15,887 | |||||||
Current portion of long-term debt, convertible note and capital lease obligations | 300,351 | 294,737 | |||||||
Total current liabilities | 618,427 | 607,800 | |||||||
Long-term debt and capital lease obligations |
25,092 |
25,038 |
|||||||
Convertible debentures | 575,000 | 575,000 | |||||||
Deferred revenuenoncurrent | 3,611 | 1,771 | |||||||
Deferred tax liabilities | 132,202 | 159,747 | |||||||
Other noncurrent liabilities | 16,424 | 15,846 | |||||||
Total liabilities | 1,370,756 | 1,385,202 | |||||||
Commitments and contingencies (Note 11) | |||||||||
Stockholders' equity: |
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Preferred stock, $0.01 par value | | | |||||||
Common stock: | |||||||||
Genzyme General Stock, $0.01 par value | 2,175 | 2,148 | |||||||
Biosurgery Stock, $0.01 par value | 407 | 405 | |||||||
Molecular Oncology Stock, $0.01 par value | 170 | 169 | |||||||
Additional paid-in capital-Genzyme General Stock | 1,883,309 | 1,810,358 | |||||||
Additional paid-in capital-Biosurgery Stock | 814,595 | 823,364 | |||||||
Additional paid-in capital-Molecular Oncology Stock | 148,943 | 148,799 | |||||||
Notes receivable from stockholders | (12,976 | ) | (12,706 | ) | |||||
Accumulated deficit | (160,129 | ) | (130,968 | ) | |||||
Accumulated other comprehensive income | 131,772 | 56,278 | |||||||
Total stockholders' equity | 2,808,266 | 2,697,847 | |||||||
Total liabilities and stockholders' equity | $ | 4,179,022 | $ | 4,083,049 | |||||
The accompanying notes are an integral part of these unaudited, consolidated financial statements.
3
GENZYME CORPORATION AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
|
Six Months Ended June 30, |
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2003 |
2002 |
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Cash Flows from Operating Activities: | |||||||||||
Net loss | $ | (29,161 | ) | $ | (63,174 | ) | |||||
Reconciliation of net loss to net cash provided by operating activities: | |||||||||||
Depreciation and amortization | 73,248 | 64,326 | |||||||||
Non-cash compensation expense | 483 | 751 | |||||||||
Provision for bad debts | 1,328 | 3,795 | |||||||||
Charge for impairment of goodwill | 102,792 | | |||||||||
Charge for impaired asset | 2,898 | | |||||||||
Equity in net loss of unconsolidated affiliates | 8,998 | 8,042 | |||||||||
(Gain) loss on investments in equity securities | 3,620 | (509 | ) | ||||||||
Loss on sale of product line | 29,367 | | |||||||||
Deferred income tax benefit | (20,367 | ) | (7,488 | ) | |||||||
Other | (599 | ) | 3,128 | ||||||||
Cumulative effect of change in accounting for goodwill | | 98,270 | |||||||||
Increase (decrease) in cash from working capital changes: | |||||||||||
Accounts receivable | (25,673 | ) | (28,034 | ) | |||||||
Inventories | 17,402 | (5,015 | ) | ||||||||
Prepaid expenses and other current assets | (7,703 | ) | (5,648 | ) | |||||||
Accounts payable, accrued expenses and deferred revenue | (3,653 | ) | (30,086 | ) | |||||||
Income taxes payable and tax benefits from stock options | 10,135 | 24,993 | |||||||||
Cash flows from operating activities | 163,115 | 63,351 | |||||||||
Cash Flows from Investing Activities: |
|||||||||||
Purchases of investments | (428,891 | ) | (260,802 | ) | |||||||
Sales and maturities of investments | 265,249 | 290,391 | |||||||||
Purchases of equity securities | (1,900 | ) | (2,210 | ) | |||||||
Proceeds from sales of equity securities | | 4,773 | |||||||||
Purchases of property, plant and equipment | (111,890 | ) | (96,199 | ) | |||||||
Investments in unconsolidated affiliates | (10,955 | ) | (14,113 | ) | |||||||
Payment of technology license fee | (12,100 | ) | | ||||||||
Note received from a collaborator | | (4,045 | ) | ||||||||
Other | 1,498 | 1,261 | |||||||||
Cash flows from investing activities | (298,989 | ) | (80,944 | ) | |||||||
Cash Flows from Financing Activities: |
|||||||||||
Proceeds from issuance of common stock | 45,142 | 21,417 | |||||||||
Proceeds from draw on credit facility | 16,000 | 35,000 | |||||||||
Payments of debt and capital lease obligations | (10,411 | ) | (1,258 | ) | |||||||
Bank overdraft | 472 | 4,157 | |||||||||
Other | 496 | (1,298 | ) | ||||||||
Cash flows from financing activities | 51,699 | 58,018 | |||||||||
Effect of exchange rate changes on cash |
19,994 |
1,567 |
|||||||||
Increase (decrease) in cash and cash equivalents |
(64,181 |
) |
41,992 |
||||||||
Cash and cash equivalents at beginning of period | 406,811 | 247,011 | |||||||||
Cash and cash equivalents at end of period | $ | 342,630 | $ | 289,003 | |||||||
Supplemental disclosure of non-cash transaction: | |||||||||||
Disposition of Cardiac Devices business assetsNote 4. |
The accompanying notes are an integral part of these unaudited, consolidated financial statements.
4
GENZYME CORPORATION AND SUBSIDIARIES
Notes To Unaudited, Consolidated Financial Statements
1. Description of Business
We are a biotechnology and human healthcare company that develops innovative products and provides services for significant unmet medical needs. We have three operating divisions:
2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation
Our unaudited, consolidated financial statements for each period include the statements of operations, balance sheets and statements of cash flows of each of our divisions, and for our corporate operations taken as a whole. We eliminate all significant intracompany items and transactions in consolidation. We prepared our unaudited, consolidated financial statements following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States. We have reclassified certain 2002 data to conform to our 2003 presentation.
These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results. Since these are interim financial statements, you should also read our consolidated financial statements and notes included in our 2002 Form 10-K. Revenues, expenses, assets and liabilities can vary from quarter to quarter. Therefore, the results and trends in these interim financial statements may not be indicative of results for future periods.
Elimination of Tracking Stock Structure
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock
5
were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock, were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery and Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and notes thereto for each of our divisions but will continue to provide our consolidated financial statements and notes thereto for our corporation as a whole.
Net Income (Loss) Per Share
Through June 30, 2003, we calculated earnings per share for each series of stock using the two-class method. To calculate basic earnings per share for each series of stock, we divided the earnings allocated to each series of stock by the weighted average number of outstanding shares of that series of stock during the applicable period. When we calculated diluted earnings per share, we also included in the denominator all potentially dilutive securities outstanding during the applicable period if inclusion of such securities was not anti-dilutive. We allocated our earnings to each series of our common stock based on the earnings attributable to that series of stock. Through June 30, 2003, the earnings attributable to Genzyme General Stock, as defined in our charter, were equal to the net income or loss of Genzyme General determined in accordance with accounting principles generally accepted in the United States, and as adjusted for tax benefits allocated to or from Genzyme General in accordance with our management and accounting policies in effect at the time. Earnings attributable to Biosurgery Stock and Molecular Oncology Stock were defined similarly and, as such, were based on the net income or loss of the corresponding division as adjusted for the allocation of tax benefits.
Through June 30, 2003, we calculated the income tax provision of each division as if such division were a separate taxpayer, which included assessing the realizability of deferred tax assets at the division level. Our management and accounting policies in effect at the time provided that if, as of the end of any fiscal quarter, a division could not use any projected annual tax benefit attributable to it to offset or reduce its current or deferred income tax expense, we could allocate the tax benefit to other divisions in proportion to their taxable income without compensating payment or allocation to the
6
division generating the benefit. The tax benefits allocated to Genzyme General and included in earnings attributable to Genzyme General Stock were (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||
Tax benefits allocated from: | ||||||||||||||
Genzyme Biosurgery | $ | 6,398 | $ | 2,994 | $ | 8,720 | $ | 7,293 | ||||||
Genzyme Molecular Oncology | 1,657 | 2,235 | 3,420 | 4,365 | ||||||||||
Total | $ | 8,055 | $ | 5,229 | $ | 12,140 | $ | 11,658 | ||||||
As of June 30, 2003, the total tax benefits previously allocated to Genzyme General from Genzyme Biosurgery and Genzyme Molecular Oncology were (amounts in thousands):
Genzyme Biosurgery | $ | 220,540 | |
Genzyme Molecular Oncology | 49,135 |
Effective July 1, 2003, in connection with the elimination of our tracking stock structure, we will cease allocating earnings or losses to Biosurgery Stock and Molecular Oncology Stock. From that date forward, all of our earnings will be allocated to Genzyme General Stock. Earnings or losses allocated to Biosurgery Stock and Molecular Oncology Stock prior to July 1, 2003 will remain allocated to those stocks and will not be affected by the elimination of our tracking stock structure. In addition, we will cease providing separate financial statements for our divisions and will only provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
Accounting for Stock-Based Compensation
In accounting for stock-based compensation, we do not recognize compensation expense for options granted under the provisions of our stock-based compensation plans with fixed terms and an exercise price greater than or equal to the fair market value of the underlying series of our common stock on the date of grant. All stock-based awards to non-employees are accounted for at their fair value in accordance with Statement of Financial Accounting Standards, or SFAS, No. 123, "Accounting for Stock-Based Compensation," as amended, and Emerging Issues Task Force, or EITF, Issue No. 96-18, "Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services."
In accordance with the disclosure requirements of SFAS No. 148, "Accounting for Stock-Based CompensationTransition and Disclosurean amendment of FASB Statement No. 123," the following table sets forth our net income (loss) data as if compensation expense for our stock-based compensation plans was determined in accordance with SFAS No. 123, as amended, based on the fair
7
value at the grant dates of the awards. The resulting compensation expense would be allocated to each division in accordance with our allocation policies (amounts in thousands, except per share amounts):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
|||||||||||
Net income (loss): | |||||||||||||||
As reported | $ | (74,530 | ) | $ | 28,323 | $ | (29,161 | ) | $ | (63,174 | ) | ||||
Add: stock-based compensation included in as reported, net of tax | 152 | 228 | 305 | 475 | |||||||||||
Deduct: pro forma stock-based compensation expense, net of tax | (31,759 | ) | (27,373 | ) | (45,143 | ) | (39,665 | ) | |||||||
Pro forma | $ | (106,137 | ) | $ | 1,178 | $ | (73,999 | ) | $ | (102,364 | ) | ||||
Net income per share allocated to Genzyme General Stock: | |||||||||||||||
Basic: | |||||||||||||||
As reported | $ | 0.33 | $ | 0.23 | $ | 0.62 | $ | 0.38 | |||||||
Add: stock-based compensation, net of tax, included in as reported | 0.00 | 0.00 | 0.00 | 0.00 | |||||||||||
Deduct: pro forma stock-based compensation expense, net of tax | (0.14 | ) | (0.11 | ) | (0.19 | ) | (0.16 | ) | |||||||
Pro forma | $ | 0.19 | $ | 0.12 | $ | 0.43 | $ | 0.22 | |||||||
Diluted: | |||||||||||||||
As reported | $ | 0.32 | $ | 0.23 | $ | 0.60 | $ | 0.36 | |||||||
Add: stock-based compensation, net of tax, included in as reported | 0.00 | 0.00 | 0.00 | 0.00 | |||||||||||
Deduct: pro forma stock-based compensation expense, net of tax | (0.14 | ) | (0.11 | ) | (0.19 | ) | (0.15 | ) | |||||||
Pro forma | $ | 0.18 | $ | 0.12 | $ | 0.41 | $ | 0.21 | |||||||
Net loss per share allocated to Biosurgery Stockbasic and diluted: | |||||||||||||||
As reported | $ | (3.46 | ) | $ | (0.38 | ) | $ | (3.76 | ) | $ | (3.31 | ) | |||
Deduct: pro forma stock-based compensation expense, net of tax | (0.03 | ) | (0.07 | ) | (0.06 | ) | (0.10 | ) | |||||||
Pro forma | $ | (3.49 | ) | $ | (0.45 | ) | $ | (3.82 | ) | $ | (3.41 | ) | |||
Net loss per share allocated to Molecular Oncology Stockbasic and diluted: | |||||||||||||||
As reported | $ | (0.26 | ) | $ | (0.37 | ) | $ | (0.54 | ) | $ | (0.73 | ) | |||
Deduct: pro forma stock-based compensation expense, net of tax | (0.04 | ) | (0.07 | ) | (0.09 | ) | (0.12 | ) | |||||||
Pro forma | $ | (0.30 | ) | $ | (0.44 | ) | $ | (0.63 | ) | $ | (0.85 | ) | |||
The effects of applying SFAS No. 123 are not likely to be representative of the effects on reported net income (loss) in future years. Additional awards of options to purchase shares of Genzyme General Stock in future years are anticipated. As a result of the elimination of our tracking stock structure, there will be no future awards of options to purchase shares of either Biosurgery Stock or Molecular Oncology Stock.
Recent Accounting Pronouncements
In November 2002, the EITF published Issue No. 00-21, "Accounting for Revenue Arrangements with Multiple Deliverables," or EITF Issue No. 00-21, which addresses how to determine whether a revenue arrangement involving multiple deliverables contains more than one unit of accounting for the purposes of revenue recognition and how the revenue arrangement consideration should be measured and allocated to the separate units of accounting. EITF Issue No. 00-21 applies to all revenue
8
arrangements that we enter into after June 30, 2003. We do not expect EITF Issue No. 00-21 to have a material impact on our financial condition or results of operations.
In January 2003, the Financial Accounting Standards Board, or FASB, issued FASB Interpretation No., or FIN, 46, "Consolidation of Variable Interest Entities, an interpretation of Accounting Research Bulletin No. 51." FIN 46 requires existing unconsolidated variable interest entities to be consolidated by their primary beneficiaries if the entities do not effectively disperse risks among parties involved. Variable interest entities that effectively disperse risk will not be consolidated unless a single party holds an interest or combination of interests that effectively recombines risks that were previously dispersed. FIN 46 also requires enhanced disclosure requirements related to variable interest entities. FIN 46 applies immediately to variable interest entities created after January 31, 2003, and to variable interest entities in which an enterprise obtains an interest after that date. It applies in the first fiscal year or interim period beginning after June 15, 2003 to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. We are currently evaluating the impact of adopting FIN 46.
In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity." SFAS No. 150 requires that certain financial instruments, which under previous guidance were accounted for as equity, must now be accounted for as liabilities. The financial instruments affected include mandatorily redeemable stock, certain financial instruments that require or may require the issuer to buy back some of its shares in exchange for cash or other assets and certain obligations that can be settled with shares of stock. SFAS No. 150 is effective for all financial instruments entered into or modified after May 31, 2003 and must be applied to our existing financial instruments effective July 1, 2003, the beginning of the first fiscal period after June 15, 2003. We do not expect SFAS No. 150 to have a material impact on our financial condition or results of operations.
9
3. Net Income (Loss) Per Share
Genzyme General Stock:
The following table sets forth our computation of basic and diluted net income per share allocated to Genzyme General Stock (amounts in thousands, except per share amounts):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
|||||||||||
Genzyme General division net income | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | |||||||
Tax benefit allocated from Genzyme Biosurgery | 6,398 | 2,994 | 8,720 | 7,293 | |||||||||||
Tax benefit allocated from Genzyme Molecular Oncology | 1,657 | 2,235 | 3,420 | 4,365 | |||||||||||
Net income allocated to Genzyme General Stockbasic and diluted | $ | 70,836 | $ | 49,640 | $ | 132,714 | $ | 80,378 | |||||||
Shares used in computing net income per common sharebasic | 216,313 | 213,917 | 215,702 | 213,624 | |||||||||||
Effect of dilutive securities: | |||||||||||||||
Stock options (1) | 6,543 | 5,708 | 5,938 | 6,710 | |||||||||||
Warrants and stock purchase rights | 11 | 9 | 10 | 15 | |||||||||||
Dilutive potential common shares (2) | 6,554 | 5,717 | 5,948 | 6,725 | |||||||||||
Shares used in computing net income per sharediluted (1,2) | 222,867 | 219,634 | 221,650 | 220,349 | |||||||||||
Net income per share of Genzyme General Stock: | |||||||||||||||
Basic | $ | 0.33 | $ | 0.23 | $ | 0.62 | $ | 0.38 | |||||||
Diluted | $ | 0.32 | $ | 0.23 | $ | 0.60 | $ | 0.36 | |||||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||
---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||
Shares of Genzyme General Stock issuable for options | 15,095 | 8,062 | 14,417 | 7,579 | ||||
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Biosurgery Stock:
For all periods presented, basic and diluted net loss per share of Biosurgery Stock are the same. We did not include the securities described in the following table in the computation of Biosurgery Stock diluted net loss per share for each period because these securities would have an anti-dilutive effect due to the net loss allocated to Biosurgery Stock (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||
---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||
Shares of Biosurgery Stock issuable for options | 7,727 | 6,798 | 7,796 | 6,746 | ||||
Warrants to purchase shares of Biosurgery Stock | 7 | 8 | 7 | 8 | ||||
Biosurgery designated shares (1) | 3,128 | 3,115 | 3,128 | 3,115 | ||||
Biosurgery designated shares reserved for options (1) | 62 | 80 | 62 | 80 | ||||
Shares issuable upon conversion of the 6.9% convertible subordinated note allocated to Genzyme Biosurgery (2) | | 358 | | 358 | ||||
Total shares excluded from the calculation of diluted net loss per share of Biosurgery Stock | 10,924 | 10,359 | 10,993 | 10,307 | ||||
Molecular Oncology Stock:
For all periods presented, basic and diluted net loss per share of Molecular Oncology Stock are the same. We did not include the securities described in the following table in the computation of Molecular Oncology Stock diluted net loss per share for each period because these securities would have an anti-dilutive effect due to the net loss allocated to Molecular Oncology Stock (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||
---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||
Shares of Molecular Oncology Stock issuable for options | 3,429 | 2,804 | 3,465 | 2,169 | ||||
Molecular Oncology designated shares (1) | 1,651 | 1,651 | 1,651 | 1,651 | ||||
Total shares excluded from the calculation of diluted net loss per share of Molecular Oncology Stock | 5,080 | 4,455 | 5,116 | 3,820 | ||||
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4. Disposition of Cardiac Devices Business Assets and Charge for Impaired Asset
On June 30, 2003, we sold substantially all of the tangible and intangible assets directly associated with our cardiac devices business, excluding our Fall River, Massachusetts manufacturing facility, the assets related to our FocalSeal® product line and certain other assets, to Teleflex Incorporated, or Teleflex, for $32.8 million in cash. In addition, Teleflex assumed $6.3 million of trade obligations directly associated with our cardiac devices business. The sale was completed on June 30, 2003 after banking hours and, as a result, the proceeds were not received until July 1, 2003. We recorded the proceeds as a receivable due from Teleflex in our consolidated balance sheet and the combined balance sheet of Genzyme Biosurgery at June 30, 2003. The assets sold had a net carrying value of $68.1 million at the time of the sale. We recorded a net loss of $29.4 million in our consolidated statements of operations and in the combined statements of operations of Genzyme Biosurgery in June 2003 in connection with this sale. We also recorded a tax benefit of $9.2 million for the reversal of related deferred tax liabilities, which was recorded in our consolidated statements of operations and allocated to Biosurgery Stock. Teleflex is leasing the manufacturing facility that we own in Fall River, Massachusetts through December 2004 with an option to extend the term to June 30, 2005. We have also entered into several transitional services agreements with Teleflex under which we will each provide and receive certain services for specified periods of time and fees as described in the agreements.
In connection with the sale of assets to Teleflex, we tested the carrying value of our manufacturing facility in Fall River, Massachusetts in June 2003 to determine whether the impairment recognition criteria in SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," had been met. In evaluating the facility for impairment, we considered the risks associated with the eventual sale of this facility, including the probability of finding a buyer for the facility, the amount of time that would likely be required to market and complete the sale of the facility and the estimated range of net proceeds that we could expect to receive. Our impairment analysis indicated that the carrying value for the Fall River facility would not be fully recoverable. As a result of this assessment, we recorded a charge for impaired asset of $2.9 million in our consolidated statements of operations and the combined statements of operations for Genzyme Biosurgery in June 2003 to write down the carrying value of the Fall River facility to its estimated fair value.
5. Inventories
|
June 30, 2003 |
December 31, 2002 |
|||||
---|---|---|---|---|---|---|---|
|
(Amounts in thousands) |
||||||
Raw materials | $ | 48,173 | $ | 45,751 | |||
Work-in-process | 94,632 | 77,274 | |||||
Finished products | 67,920 | 115,784 | |||||
Total | $ | 210,725 | $ | 238,809 | |||
In June 2003, we sold $21.3 million of inventory related to our cardiac devices business to Teleflex.
We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory that has not yet been approved for sale. If a product is not approved for sale, it would likely result in the write off of the inventory and a charge to earnings. At June 30, 2003, our total inventories for products that have not yet been approved for sale are not significant.
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We own a 50% interest in our joint venture with BioMarin Pharmaceutical, Inc., or BioMarin, for the development and commercialization of Aldurazyme® enzyme as an enzyme replacement therapy of people with an LSD known as mucopolysaccharidosis I, or MPS I. We received FDA marketing approval for Aldurazyme enzyme on April 30, 2003 and European marketing approval for the product from the European Commission on June 11, 2003. At June 30, 2003, our joint venture has $6.9 million of inventory related to a revised formulation of Aldurazyme enzyme that has not yet been approved for sale, of which $3.5 million represents our portion of the unapproved inventory for the joint venture. If this inventory is not approved for sale, our joint venture would likely have to write off the inventory, and, as a result, we would have to record a charge to earnings for our portion of the inventory write off.
6. Goodwill and Other Intangible Assets
Effective January 1, 2002, we adopted SFAS No. 142, "Goodwill and Other Intangible Assets," which requires that ratable amortization of goodwill and certain intangible assets be replaced with periodic tests of goodwill's impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. We are required to perform impairment tests under SFAS No. 142 annually, which we perform in the third quarter, and whenever events or changes in circumstance suggest that the carrying value of an asset may not be recoverable.
Cumulative Effect of Change in Accounting for Goodwill
Upon adoption of SFAS No. 142, we tested the goodwill of Genzyme Biosurgery's cardiothoracic reporting unit in accordance with the transitional provisions of that standard, using the present value of expected future cash flows to estimate the fair value of this reporting unit. We recorded an impairment charge of $98.3 million, which we reflected as a cumulative effect of a change in accounting for goodwill in our consolidated statements of operations and the combined statements of operations for Genzyme Biosurgery in March 2002.
13
Goodwill
Effective January 1, 2002, in accordance with the provisions of SFAS No. 142, we ceased amortizing goodwill. The following table provides information on the changes in our net goodwill during the six months ended June 30, 2003 (amounts in thousands):
|
As of December 31, 2002 |
Adjustments |
Impairment |
As of June 30, 2003 |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Goodwill: | ||||||||||||||||
Genzyme General: | ||||||||||||||||
Therapeutics | $ | 380,854 | $ | | $ | | $ | 380,854 | ||||||||
Renal | 82,477 | | | 82,477 | ||||||||||||
Diagnostic Products (1) | 33,216 | 4 | | 33,220 | ||||||||||||
Other (1) | 56,633 | 26 | | 56,659 | ||||||||||||
Total | 553,180 | 30 | | 553,210 | ||||||||||||
Genzyme Biosurgery (2) | 122,271 | | (113,857 | ) | 8,414 | |||||||||||
Genzyme Molecular Oncology | | | | | ||||||||||||
Total | 675,451 | 30 | (113,857 | ) | 561,624 | |||||||||||
Accumulated amortization (2) | (83,376 | ) | | 11,065 | (72,311 | ) | ||||||||||
Goodwill, net | $ | 592,075 | $ | 30 | $ | (102,792 | ) | $ | 489,313 | |||||||
14
Other Intangible Assets
The following table contains information on our other intangible assets for the periods presented (amounts in thousands):
|
As of June 30, 2003 |
As of December 31, 2002 |
|||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
|||||||||||||
Technology | $ | 551,867 | $ | (110,209 | ) | $ | 441,658 | $ | 551,836 | $ | (88,222 | ) | $ | 463,614 | |||||
Patents (1) | 184,373 | (36,587 | ) | 147,786 | 196,997 | (37,014 | ) | 159,983 | |||||||||||
Trademarks (1) | 58,027 | (13,035 | ) | 44,992 | 91,754 | (15,945 | ) | 75,809 | |||||||||||
License fees (1,2) | 38,072 | (8,123 | ) | 29,949 | 26,862 | (7,261 | ) | 19,601 | |||||||||||
Distribution agreements | 13,950 | (4,422 | ) | 9,528 | 13,950 | (3,550 | ) | 10,400 | |||||||||||
Customer lists | 8,324 | (4,447 | ) | 3,877 | 8,324 | (4,031 | ) | 4,293 | |||||||||||
Other | 11,602 | (11,083 | ) | 519 | 12,242 | (11,464 | ) | 778 | |||||||||||
Total | $ | 866,215 | $ | (187,906 | ) | $ | 678,309 | $ | 901,965 | $ | (167,487 | ) | $ | 734,478 | |||||
All of our other intangible assets are amortized over their estimated useful lives, which range from 1.5 years to 15 years. Total amortization expense for our other intangible assets was:
Amortization expense includes $0.3 million for the three months and $0.6 million for the six months ended June 30, 2002 related to the amortization of a non-compete agreement that was charged to cost of products sold. This agreement concluded and the related intangible asset was fully amortized as of December 31, 2002.
15
The estimated future amortization expense for our other intangible assets as of June 30, 2003 for the remainder of fiscal year 2003 and the five succeeding fiscal years is as follows (amounts in thousands):
Year Ended December 31, |
Estimated Amortization Expense |
||
---|---|---|---|
2003 (remaining six months) | $ | 34,482 | |
2004 | 68,525 | ||
2005 | 68,173 | ||
2006 | 65,807 | ||
2007 | 65,804 | ||
2008 | 65,030 |
7. Sale of GTC Common Stock
On April 4, 2002, GTC Biotherapeutics, Inc., formerly known as Genzyme Transgenics Corporation and which we refer to as GTC, purchased approximately 2.8 million shares of GTC common stock held by us and allocated to Genzyme General for an aggregate consideration of $9.6 million. We received $4.8 million in cash and a promissory note for the remaining amount. The shares of GTC common stock sold were valued at $3.385 per share in this transaction, using the simple average of the high and low transaction prices quoted on the Nasdaq National Market on April 1, 2002. We have committed to a 24-month lock-up provision on the remaining 4.9 million shares of GTC common stock held by us and allocated to Genzyme General, which is approximately 17% of the shares of GTC common stock outstanding as of June 30, 2003. We accounted for our investment in GTC under the equity method of accounting until May 2002, at which point our ownership interest and board representation was reduced below 20% and we did not have any other factors of significant influence. Accordingly, we ceased to have significant influence over GTC and we began accounting for our investment in GTC under the cost method of accounting in June 2002. Equity in net loss of unconsolidated affiliates in our consolidated statements of operations and the combined statements of operations of Genzyme General includes charges of $1.0 million for the three months and $2.1 million for the six months ended June 30, 2002 representing our portion of the losses of GTC.
8. Investments in Equity Securities
At December 31, 2002, the remaining 4.9 million shares of GTC common stock that we held did not qualify as marketable securities under SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities" because we were within the first 12 months of the 24-month lock-up provision described above. As a result, we carried our investment in GTC on our consolidated balance sheets and the combined balance sheets of Genzyme General at cost, subject to review for impairment. Effective April 4, 2003, we began the last 12 months of the 24-month lock-up provision and, as a result, the remaining shares of GTC common stock that we hold now qualify as marketable securities under SFAS No. 115 and are carried on our consolidated balance sheets and the combined balance sheets of Genzyme General at fair value.
We review the carrying value of each of our strategic investments in equity securities on a quarterly basis for potential impairment. In June 2003, we recorded a $3.6 million impairment charge in connection with our investment in the common stock of ABIOMED Inc., or ABIOMED, because we
16
considered the decline in value of this investment to be other than temporary. Given the significance and duration of the decline as of June 30, 2003, we concluded that it was unclear over what period the recovery of the stock price for this investment would take place, and, accordingly, that any evidence suggesting that the investment would recover to at least our historical cost was not sufficient to overcome the presumption that the current market price was the best indicator of the value of this investment.
At June 30, 2003, our stockholders' equity includes $16.4 million of unrealized gains and $0.3 million of unrealized losses related to our other investments in equity securities, all of which were allocated to Genzyme General. We believe the losses related to our other investments in equity securities are temporary.
9. Investment in Peptimmune, Inc.
In January 2002, we formed Peptimmune, Inc., or Peptimmune, as our wholly-owned subsidiary, by contributing $5.0 million of cash and $0.3 million of other assets to Peptimmune in exchange for 5.5 million shares of Peptimmune's Series A voting preferred stock and 100 shares of Peptimmune common stock. We allocated our investment in Peptimmune to Genzyme General. We consolidated the results of Peptimmune through February 2003 because during that period we owned 100% of its outstanding stock. In March 2003, our investment in Peptimmune decreased to approximately 12% as a result of the sale by Peptimmune of shares of its Series B voting preferred stock to third party investors. In accordance with our policy pertaining to affiliate sales of stock, we recorded a $2.9 million net gain ($4.5 million pre-tax) due to this sale, which was recorded as an increase to our investment in Peptimmune in other noncurrent assets and an increase to other comprehensive income in stockholders' equity in our consolidated balance sheet. Although our ownership interest in Peptimmune has declined below 20%, we account for our investment in Peptimmune under the equity method of accounting because certain factors exist that cause us to continue to have significant influence over Peptimmune, including that the chairman, president and chief executive officer of Peptimmune is a member of our board of directors, one of our corporate officers is a consultant to Peptimmune and we have service agreements with Peptimmune. Our equity in the net losses of Peptimmune have not been significant to date.
10. Revolving Credit Facility and Convertible Note
We have access to a $350.0 million revolving credit facility, all of which matures in December 2003. During the second quarter of 2003, we drew down $16.0 million under this facility and allocated the proceeds to Genzyme Biosurgery. At June 30, 2003, $300.0 million remained outstanding under this facility, all of which was repaid on August 11, 2003. Borrowings under this facility bear interest at LIBOR plus an applicable margin, which was, in aggregate, 2.5% at June 30, 2003. The terms of the revolving credit facility include various covenants, including financial covenants, which require us to meet minimum liquidity and interest coverage ratios and to meet maximum leverage ratios. We currently are in compliance with these covenants. We intend to refinance our revolving credit facility prior to its expiration in December 2003.
In May 2003, we used $10.0 million of cash allocated to Genzyme Biosurgery to satisfy the 6.9% convertible note we assumed upon our acquisition of Biomatrix.
17
11. Other Commitments and Contingencies
We periodically become subject to legal proceedings and claims arising in connection with our business. We do not believe that there were any asserted claims against us as of June 30, 2003 which, if adversely decided, would have a material adverse effect on our results of operations, financial condition or liquidity.
Two lawsuits have been filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock. The first case, filed in Massachusetts Superior Court on May 28, 2003, is a purported class action on behalf of holders of Biosurgery Stock alleging a breach of an implied covenant of good faith and fair dealing in our charter and a breach of our board of directors' fiduciary duties. The plaintiff in this case is seeking an injunction to adjust the exchange ratio for the tracking stock exchange. We filed our answer to this complaint on July 21, 2003. The second case, filed in the United States District Court for the Southern District of New York on June 3, 2003, was brought by two holders of Biosurgery Stock alleging violations of federal securities laws as well as a breach of an implied covenant of good faith and fair dealing in our charter, a breach of our board of directors' fiduciary duties, common law fraud, and a breach of the merger agreement with Biomatrix. The plaintiffs sought an injunction to prevent the tracking stock exchange, but they withdrew that motion on June 19, 2003. The plaintiffs are also seeking an adjustment to the exchange ratio, the recission of the acquisition of Biomatrix, and unspecified compensatory damages. We filed a motion to dismiss this complaint on July 2, 2003. Rather than reply to this motion, the plaintiffs amended their complaint on August 1, 2003. This amended complaint asserts class action status and, except for the recission on the Biomatrix acquisition, seeks the same relief as the original complaint. We believe both cases are without merit and plan on defending against them vigorously. We are not able to predict the outcome of these cases or estimate the amount or range of any possible loss we might incur if we do not prevail in the final, non-appealable determinations of these matters. Therefore, we have not accrued any amounts in connection with this contingency.
In 2001, Genzyme Limited, our wholly-owned subsidiary in the United Kingdom, established a home nursing and infusion service to support patients receiving Cerezyme® enzyme and our other enzyme replacement therapies following the expiration of a contract with a third party service provider. This third party lodged a complaint with the Office of Fair Trading in the United Kingdom. The OFT is a non-governmental organization empowered to enforce certain consumer and competition legislation in the United Kingdom. The OFT commenced an investigation of this service, alleging that it contravened competition laws in the United Kingdom. While we believe that the provision of home healthcare services by our subsidiary and our pricing for Cerezyme enzyme in the United Kingdom fully complies with applicable laws, we cooperated in this investigation. In March 2003, the OFT ruled that this service did, in fact, violate United Kingdom competition law, and as a result fined Genzyme Limited approximately 6.8 million Pounds Sterling and required modifications to our pricing structure for Cerezyme enzyme in the United Kingdom. We have appealed this finding to the United Kingdom Competition Appeal Tribunal, receiving an automatic stay of the fine, and seeking a stay of the order on Cerezyme pricing. Hearings were held in April 2003 and May 2003 regarding the stay of the OFT's decision. In May 2003, the Tribunal issued an order that stays the OFT's decision but which requires Genzyme Limited to provide one supplier a modest discount during the pendency of the appeal process. Genzyme Limited filed its appeal brief in May 2003 and expects the appeal hearing to take place in September 2003. We are confident that we will prevail on appeal and believe it probable that
18
we will not have to pay a material fine or permanently modify our Cerezyme pricing structure. We have not accrued any amounts in connection with this contingency.
The staff of the FTC is investigating our acquisition of Novazyme Pharmaceuticals, Inc. The FTC is one of the agencies responsible for enforcing federal antitrust laws. While we do not believe that the acquisition should be deemed to contravene antitrust laws, we have been cooperating with the FTC in its investigation which is currently ongoing.
In April 2002, Snowden Pencer, Inc., or SPI, initiated dispute resolution procedures alleging that we breached representations and warranties and committed fraud and intentional misconduct relating to the sale of our Snowden-Pencer line of surgical instruments to SPI in November 2001. An arbitration hearing is ongoing. We believe the claims made by SPI are without merit and intend to vigorously defend the claims. Based on the advice of counsel, management does not believe that it is probable that we will be required to pay a material amount in connection with this claim. We have not accrued any amounts in connection with this contingency.
Guarantees
In November 2002, the FASB issued FIN 45 "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Othersan interpretation of FASB Statements No. 5, 57 and 107 and rescission of FASB Interpretation No. 34." FIN 45 clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability for the fair value of the obligation undertaken in issuing certain guarantees. FIN 45 also requires additional disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under certain guarantees it has issued. The accounting requirements for the initial recognition of guarantees are applicable on a prospective basis for guarantees issued or modified after December 31, 2002.
We have agreements whereby we indemnify our officers and directors for certain events or occurrences while the officer or director is, or was serving, at our request in such capacity. The term of the indemnification period is for the officer's or director's lifetime. The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited; however, we believe the estimated fair value of these indemnification agreements is minimal. We have no liabilities recorded for these agreements as of June 30, 2003.
We enter into standard indemnification agreements in our ordinary course of business. Pursuant to these agreements, we indemnify, hold harmless, and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified parties, generally our business partners or customers. The term of these indemnification agreements is generally perpetual any time after execution of the agreement. The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited. The estimated fair value of these indemnification agreements is minimal. We have no liabilities recorded for these agreements as of June 30, 2003.
19
12. Tax Provision
|
Three Months Ended June 30 |
|
Six Months Ended June 30, |
|
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||
Provision for income taxes | $ | (9,726 | ) | $ | (10,293 | ) | (6)% | $ | (28,724 | ) | $ | (13,431 | ) | 114% | ||
Effective tax rate | 15 | % | 27 | % | 6,573 | % | 28 | % |
Our tax rates for all periods presented vary from the United States statutory tax rate as a result of our:
13. Segment Information
In accordance with SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information," we present segment information in a manner consistent with the method we use to report this information to our management. Applying SFAS No. 131, we have five reportable segments:
20
We provide information concerning the operations of these reportable segments in the following table (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||||
Revenues: | ||||||||||||||||
Genzyme General: | ||||||||||||||||
Therapeutics | $ | 220,158 | $ | 173,933 | $ | 417,369 | $ | 335,240 | ||||||||
Renal (1) | 66,002 | 39,543 | 124,768 | 69,075 | ||||||||||||
Diagnostic Products | 22,554 | 20,530 | 45,750 | 40,368 | ||||||||||||
Other (2) | 38,216 | 32,303 | 72,580 | 63,091 | ||||||||||||
Eliminations/Adjustments (3) | 733 | 859 | 1,241 | 1,541 | ||||||||||||
Total Genzyme General | 347,663 | 267,168 | 661,708 | 509,315 | ||||||||||||
Genzyme Biosurgery | 68,758 | 62,863 | 134,384 | 116,234 | ||||||||||||
Genzyme Molecular Oncology | 2,482 | 2,161 | 4,670 | 4,583 | ||||||||||||
Total | $ | 418,903 | $ | 332,192 | $ | 800,762 | $ | 630,132 | ||||||||
Net income (loss): |
||||||||||||||||
Genzyme General: | ||||||||||||||||
Therapeutics | $ | 60,813 | $ | 43,349 | $ | 111,945 | $ | 75,191 | ||||||||
Renal (1) | 5,368 | (4,503 | ) | 9,163 | (9,630 | ) | ||||||||||
Diagnostic Products | 1,165 | 681 | 3,127 | (764 | ) | |||||||||||
Other (2) | 2,980 | 1,024 | 4,325 | 3,215 | ||||||||||||
Eliminations/Adjustments (3) | (7,545 | ) | 3,860 | (7,986 | ) | 708 | ||||||||||
Net income for Genzyme General | 62,781 | 44,411 | 120,574 | 68,720 | ||||||||||||
Genzyme Biosurgery: | ||||||||||||||||
Net loss for Genzyme Biosurgery before cumulative effect of change in accounting for goodwill (4) | (152,554 | ) | (17,522 | ) | (166,656 | ) | (37,904 | ) | ||||||||
Cumulative effect of change in accounting for goodwill (5) | | | | (98,270 | ) | |||||||||||
Net loss for Genzyme Biosurgery | (152,554 | ) | (17,522 | ) | (166,656 | ) | (136,174 | ) | ||||||||
Genzyme Molecular Oncology | (4,409 | ) | (6,237 | ) | (9,224 | ) | (12,268 | ) | ||||||||
Eliminations/Adjustments (6) | 19,652 | 7,671 | 26,145 | 16,548 | ||||||||||||
Total | $ | (74,530 | ) | $ | 28,323 | $ | (29,161 | ) | $ | (63,174 | ) | |||||
21
Segment Assets
We provide information concerning the assets of our reportable segments in the following table (amounts in thousands):
|
June 30, 2003 |
December 31, 2002 |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
Segment Assets: | ||||||||||
Genzyme General (1): | ||||||||||
Therapeutics | $ | 1,037,674 | $ | 1,127,493 | ||||||
Renal | 480,717 | 467,164 | ||||||||
Diagnostic Products | 103,308 | 103,636 | ||||||||
Other (2) | 95,136 | 89,705 | ||||||||
Eliminations/Adjustments (3) | 2,109,811 | 1,767,803 | ||||||||
Total Genzyme General | 3,826,646 | 3,555,801 | ||||||||
Genzyme Biosurgery (4) | 392,011 | 560,792 | ||||||||
Genzyme Molecular Oncology | 1,610 | 13,981 | ||||||||
Eliminations/Adjustments (5) | (41,245 | ) | (47,525 | ) | ||||||
Total | $ | 4,179,022 | $ | 4,083,049 | ||||||
22
14. Subsequent Event
On August 13, 2003, we launched an all cash tender offer for all of the outstanding shares of SangStat Medical Corporation, or SangStat, for $22.50 per outstanding share, or approximately $600 million. The transaction, which we expect to be completed in September 2003, is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
23
GENZYME GENERAL
A Division of Genzyme Corporation
Combined Statements of Operations
(Unaudited, amounts in thousands)
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 321,553 | $ | 242,756 | $ | 610,592 | $ | 461,219 | ||||||||
Net service sales | 25,321 | 22,420 | 49,776 | 43,595 | ||||||||||||
Revenues from research and development contracts: | ||||||||||||||||
Related parties | 684 | 784 | 1,122 | 1,396 | ||||||||||||
Other | 105 | 1,208 | 218 | 3,105 | ||||||||||||
Total revenues | 347,663 | 267,168 | 661,708 | 509,315 | ||||||||||||
Operating costs and expenses: |
||||||||||||||||
Cost of products sold | 75,195 | 50,765 | 144,771 | 98,364 | ||||||||||||
Cost of services sold | 16,479 | 12,854 | 29,943 | 24,720 | ||||||||||||
Selling, general and administrative | 95,203 | 80,519 | 180,449 | 156,909 | ||||||||||||
Research and development (including research and development related to contracts) | 58,834 | 56,477 | 115,163 | 120,313 | ||||||||||||
Amortization of intangibles | 9,873 | 9,723 | 19,609 | 19,441 | ||||||||||||
Total operating costs and expenses | 255,584 | 210,338 | 489,935 | 419,747 | ||||||||||||
Operating income | 92,079 | 56,830 | 171,773 | 89,568 | ||||||||||||
Other income (expenses): |
||||||||||||||||
Equity in net loss of unconsolidated affiliates | (4,804 | ) | (3,948 | ) | (8,998 | ) | (8,042 | ) | ||||||||
Gain (loss) on investments in equity securities | (3,620 | ) | 343 | (3,620 | ) | 509 | ||||||||||
Other | 774 | 1,749 | 1,554 | 852 | ||||||||||||
Investment income | 12,058 | 12,079 | 23,339 | 25,031 | ||||||||||||
Interest expense | (4,328 | ) | (4,678 | ) | (8,605 | ) | (9,219 | ) | ||||||||
Total other income (expenses) | 80 | 5,545 | 3,670 | 9,131 | ||||||||||||
Income before income taxes | 92,159 | 62,375 | 175,443 | 98,699 | ||||||||||||
Provision for income taxes | (29,378 | ) | (17,964 | ) | (54,869 | ) | (29,979 | ) | ||||||||
Division net income | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | ||||||||
Comprehensive income (loss), net of tax: |
||||||||||||||||
Division net income | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | ||||||||
Other comprehensive income (loss), net of tax: | ||||||||||||||||
Foreign currency translation adjustments | 43,768 | 47,503 | 57,172 | 42,140 | ||||||||||||
Gain on affiliate sale of stock, net of tax | | | 2,856 | | ||||||||||||
Unrealized gains (losses) on securities: | ||||||||||||||||
Unrealized gains (losses) on securities, net of tax | 7,620 | (2,923 | ) | 11,666 | (26,788 | ) | ||||||||||
Reclassification adjustment for losses included in division net income | 2,288 | 81 | 2,288 | 81 | ||||||||||||
Unrealized gains (losses) on securities, net | 9,908 | (2,842 | ) | 13,954 | (26,707 | ) | ||||||||||
Other | (146 | ) | (541 | ) | (77 | ) | (163 | ) | ||||||||
Other comprehensive income (loss) | 53,530 | 44,120 | 73,905 | (15,270 | ) | |||||||||||
Comprehensive income | $ | 116,311 | $ | 88,531 | $ | 194,479 | $ | 83,990 | ||||||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
24
GENZYME GENERAL
A Division of Genzyme Corporation
Combined Balance Sheets
(Unaudited, amounts in thousands)
|
June 30, 2003 |
December 31, 2002 |
||||||
---|---|---|---|---|---|---|---|---|
ASSETS | ||||||||
Current assets: |
||||||||
Cash and cash equivalents | $ | 314,856 | $ | 372,605 | ||||
Short-term investments | 246,183 | 94,339 | ||||||
Accounts receivable, net | 290,754 | 251,318 | ||||||
Inventories | 192,689 | 196,396 | ||||||
Prepaid expenses and other current assets | 50,766 | 42,558 | ||||||
Due from Genzyme Biosurgery | 29,178 | 32,641 | ||||||
Due from Genzyme Molecular Oncology | 4,855 | 5,494 | ||||||
Deferred tax assets | 104,834 | 105,094 | ||||||
Total current assets | 1,234,115 | 1,100,445 | ||||||
Property, plant and equipment, net |
841,175 |
749,840 |
||||||
Long-term investments | 702,910 | 682,201 | ||||||
Notes receivablerelated parties | 12,131 | 11,918 | ||||||
Goodwill, net | 481,729 | 481,699 | ||||||
Other intangible assets, net | 444,161 | 451,661 | ||||||
Investments in equity securities | 67,046 | 42,945 | ||||||
Due from Genzyme Biosurgerynoncurrent | 8,443 | 9,390 | ||||||
Other noncurrent assets | 34,936 | 25,702 | ||||||
Total assets | $ | 3,826,646 | $ | 3,555,801 | ||||
LIABILITIES AND DIVISION EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable | $ | 31,196 | $ | 35,978 | ||||
Accrued expenses | 174,137 | 170,186 | ||||||
Income taxes payable | 69,413 | 58,107 | ||||||
Deferred revenue | 9,791 | 10,588 | ||||||
Current portion of long-term debt and capital lease obligations | 26 | 13 | ||||||
Total current liabilities | 284,563 | 274,872 | ||||||
Long-term debt and capital lease obligations |
25,092 |
25,038 |
||||||
Convertible debentures | 575,000 | 575,000 | ||||||
Deferred tax liability | 59,551 | 81,933 | ||||||
Deferred revenuenoncurrent | 3,611 | | ||||||
Other noncurrent liabilities | 13,348 | 13,074 | ||||||
Total liabilities | 961,165 | 969,917 | ||||||
Commitments and contingencies (Note 9) |
||||||||
Division equity |
2,865,481 |
2,585,884 |
||||||
Total liabilities and division equity | $ | 3,826,646 | $ | 3,555,801 | ||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
25
GENZYME GENERAL
A Division of Genzyme Corporation
Combined Statements of Cash Flows
(Unaudited, amounts in thousands)
|
Six Months Ended June 30, |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
|||||||||
Cash Flows from Operating Activities: | |||||||||||
Division net income | $ | 120,574 | $ | 68,720 | |||||||
Reconciliation of division net income to net cash from operating activities: | |||||||||||
Depreciation and amortization | 54,485 | 45,205 | |||||||||
Non-cash compensation expense | 483 | 751 | |||||||||
Provision for bad debts | 990 | 3,424 | |||||||||
Equity in net loss of unconsolidated affiliates | 8,998 | 8,042 | |||||||||
(Gain) loss on investments in equity securities | 3,620 | (509 | ) | ||||||||
Deferred income tax benefit | (6,362 | ) | (7,488 | ) | |||||||
Other | 5 | 3,305 | |||||||||
Increase (decrease) in cash from working capital changes: | |||||||||||
Accounts receivable | (30,266 | ) | (30,303 | ) | |||||||
Inventories | 13,679 | (7,335 | ) | ||||||||
Prepaid expenses and other current assets | (6,889 | ) | (5,919 | ) | |||||||
Due from Genzyme Biosurgery | 4,410 | (1,947 | ) | ||||||||
Due from Genzyme Molecular Oncology | 639 | 1,186 | |||||||||
Accounts payable, accrued expenses and deferred revenue | (3,527 | ) | (6,642 | ) | |||||||
Income taxes payable and tax benefits from stock options | 24,194 | 26,880 | |||||||||
Cash flows from operating activities | 185,033 | 97,370 | |||||||||
Cash Flows from Investing Activities: |
|||||||||||
Purchases of investments | (428,891 | ) | (239,358 | ) | |||||||
Sales and maturities of investments | 253,705 | 288,872 | |||||||||
Purchases of equity securities | (1,525 | ) | (2,210 | ) | |||||||
Proceeds from sales of equity securities | | 4,773 | |||||||||
Purchases of property, plant and equipment | (109,741 | ) | (94,268 | ) | |||||||
Investments in unconsolidated affiliates | (10,955 | ) | (14,113 | ) | |||||||
Payment of technology license fee | (12,100 | ) | | ||||||||
Note received from a collaborator | | (4,045 | ) | ||||||||
Other | 383 | 1,263 | |||||||||
Cash flows from investing activities | (309,124 | ) | (59,086 | ) | |||||||
Cash Flows from Financing Activities: |
|||||||||||
Allocated proceeds from issuance of Genzyme General Stock | 44,690 | 20,801 | |||||||||
Payments of debt and capital lease obligations | (12 | ) | (775 | ) | |||||||
Receipt of NeuroCell joint venture refund from Genzyme Biosurgery | | 27,063 | |||||||||
Bank overdraft | 897 | 4,469 | |||||||||
Other | 406 | (3,791 | ) | ||||||||
Cash flows from financing activities | 45,981 | 47,767 | |||||||||
Effect of exchange rate changes on cash |
20,361 |
3,128 |
|||||||||
Increase (decrease) in cash and cash equivalents |
(57,749 |
) |
89,179 |
||||||||
Cash and cash equivalents at beginning of period | 372,605 | 167,253 | |||||||||
Cash and cash equivalents at end of period | $ | 314,856 | $ | 256,432 | |||||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
26
GENZYME GENERAL
A Division of Genzyme Corporation
Notes To Unaudited, Combined Financial Statements
1. Description of Business
Genzyme General is our operating division that develops and markets:
2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The unaudited, combined financial statements of Genzyme General for each period include the statements of operations, balance sheets and statements of cash flows of the businesses we allocate to Genzyme General. We also allocate a portion of our corporate operations to Genzyme General using methods described in our allocation policy included in Note A., "Summary of Significant Accounting PoliciesAllocation Policy," to Genzyme General's combined financial statements included in Exhibit 13.2 to our 2002 Form 10-K. These unaudited, combined financial statements are prepared using amounts included in our unaudited, consolidated financial statements included in this Form 10-Q. We prepared these unaudited, combined financial statements for Genzyme General following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States. We have reclassified certain 2002 data to conform to our 2003 presentation.
These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of Genzyme General's financial position and operating results. Since these are interim financial statements, you should also read the combined financial statements and notes for Genzyme General included in our 2002 Form 10-K.
Elimination of Tracking Stock Structure
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock, were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all
27
of our assets and liabilities that had been allocated to Genzyme Biosurgery and Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangements previously approved by our board of directors that had made a portion of Genzyme General's cash available to Genzyme Biosurgery and Genzyme Molecular Oncology. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and notes thereto for each of our divisions but will continue to provide our consolidated financial statements and notes thereto for our corporation as a whole.
Accounting for Stock-Based Compensation
In accounting for stock-based compensation, we do not recognize compensation expense for options granted under the provisions of our stock-based compensation plans with fixed terms and an exercise price greater than or equal to the fair market value of the underlying series of our common stock on the date of grant. All stock-based awards to non-employees are accounted for at their fair value in accordance with SFAS No. 123, "Accounting for Stock-Based Compensation," as amended, and EITF Issue No. 96-18, "Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services."
In accordance with the disclosure requirements of SFAS No. 148, "Accounting for Stock-Based CompensationTransition and Disclosurean amendment of FASB Statement No. 123," the following table sets forth Genzyme General's division net income data as if compensation expense for our stock-based compensation plans was determined in accordance with SFAS No. 123, as amended, based on the fair value at the grant dates of the awards (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||
Division net income: | ||||||||||||||
As reported | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | ||||||
Add: stock-based compensation included in as reported, net of tax | 152 | 228 | 305 | 475 | ||||||||||
Deduct: pro forma stock-based compensation expense, net of tax | (30,576 | ) | (24,994 | ) | (42,697 | ) | (35,982 | ) | ||||||
Pro forma | $ | 32,357 | $ | 19,645 | $ | 78,182 | $ | 33,213 | ||||||
Recent Accounting Pronouncements
We have included the impact that recently issued accounting standards will have on our financial statements in Note 2., "Basis of Presentation and Significant Accounting PoliciesRecent Accounting Pronouncements," to our consolidated financial statements, which we incorporate by reference into this note.
28
3. Net Income Per Share
Note 3., "Net Income (Loss) Per Share," to our consolidated financial statements contains information regarding the calculation of earnings per share for each series of our stock using the two-class method. We present earnings per share data only in our consolidated financial statements because Genzyme Corporation is the issuer of the securities. Our divisions do not and cannot issue securities because they are not companies or legal entities.
4. Inventories
|
June 30, 2003 |
December 31, 2002 |
|||||
---|---|---|---|---|---|---|---|
|
(Amounts in thousands) |
||||||
Raw materials | $ | 43,554 | $ | 33,934 | |||
Work-in-process | 89,497 | 68,441 | |||||
Finished products | 59,638 | 94,021 | |||||
Total | $ | 192,689 | $ | 196,396 | |||
Genzyme General capitalizes inventory produced for commercial sale, which may result in the capitalization of inventory that has not yet been approved for sale. If a product is not approved for sale, it would likely result in the write off of the inventory and a charge to earnings. At June 30, 2003, Genzyme General's total inventories for products that have not yet been approved for sale are not significant.
We own a 50% interest in our joint venture with BioMarin for the development and commercialization of Aldurazyme enzyme as an enzyme replacement therapy for people with an LSD known as MPS I. We received FDA marketing approval for Aldurazyme enzyme on April 30, 2003 and European marketing approval for the product from the European Commission on June 11, 2003. At June 30, 2003, our joint venture has $6.9 million of inventory related to a revised formulation of Aldurazyme enzyme that has not yet been approved for sale, of which $3.5 million represents our portion of the unapproved inventory of the joint venture. If this inventory is not approved for sale, our joint venture would likely have to write off the inventory, and, as a result, we would have to record a charge to earnings for our portion of the inventory write off.
5. Goodwill and Other Intangible Assets
Effective January 1, 2002, Genzyme General adopted SFAS No. 142, "Goodwill and Other Intangible Assets," which requires that ratable amortization of goodwill and certain intangible assets be replaced with periodic tests of goodwill's impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. We are required to perform impairment tests under SFAS No. 142 annually, which we perform in the third quarter, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. During the three and six months ended June 30, 2003, there were no events or changes in circumstances that would have caused an impairment review of the goodwill or other intangible assets allocated to Genzyme General.
29
Goodwill
Effective January 1, 2002, in accordance with the provisions of SFAS No. 142, Genzyme General ceased amortizing goodwill. The following table provides information on the changes in net goodwill attributable to Genzyme General's reporting segments during the six months ended June 30, 2003 (amounts in thousands):
|
As of December 31, 2002 |
Adjustments |
As of June 30, 2003 |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Goodwill: | ||||||||||||
Therapeutics | $ | 380,854 | $ | | $ | 380,854 | ||||||
Renal | 82,477 | | 82,477 | |||||||||
Diagnostic Products (1) | 33,216 | 4 | 33,220 | |||||||||
Other (1) | 56,633 | 26 | 56,659 | |||||||||
Total | 553,180 | 30 | 553,210 | |||||||||
Accumulated amortization | (71,481 | ) | | (71,481 | ) | |||||||
Goodwill, net | $ | 481,699 | $ | 30 | $ | 481,729 | ||||||
Other Intangible Assets
The following table contains information on Genzyme General's other intangible assets for the periods presented (amounts in thousands):
|
As of June 30, 2003 |
As of December 31, 2002 |
|||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
|||||||||||||
Technology | $ | 378,489 | $ | (70,379 | ) | $ | 308,110 | $ | 378,457 | $ | (56,294 | ) | $ | 322,163 | |||||
Patents | 117,574 | (20,766 | ) | 96,808 | 117,574 | (16,863 | ) | 100,711 | |||||||||||
Trademarks | 6,526 | (1,108 | ) | 5,418 | 6,526 | (890 | ) | 5,636 | |||||||||||
License fees (1) | 38,072 | (8,123 | ) | 29,949 | 25,972 | (7,114 | ) | 18,858 | |||||||||||
Customer lists | 8,324 | (4,448 | ) | 3,876 | 8,324 | (4,031 | ) | 4,293 | |||||||||||
Other | 10,045 | (10,045 | ) | | 10,045 | (10,045 | ) | | |||||||||||
Total | $ | 559,030 | $ | (114,869 | ) | $ | 444,161 | $ | 546,898 | $ | (95,237 | ) | $ | 451,661 | |||||
All of Genzyme General's other intangible assets are amortized over their estimated useful lives, which range from 1.5 years to 15 years. Total amortization expense for Genzyme General's other intangible assets was:
30
Amortization expense includes $0.3 million for the three months and $0.6 million for the six months ended June 30, 2002 related to the amortization of a non-compete agreement that was charged to cost of products sold. This agreement concluded and the related intangible asset was fully amortized as of December 31, 2002.
The estimated future amortization expense for Genzyme General's other intangible assets as of June 30, 2003 for the remainder of fiscal year 2003 and the five succeeding fiscal years is as follows (amounts in thousands):
Year Ended December 31, |
Estimated Amortization Expense |
||
---|---|---|---|
2003 (remaining six months) | $ | 19,931 | |
2004 | 39,744 | ||
2005 | 39,651 | ||
2006 | 37,285 | ||
2007 | 37,282 | ||
2008 | 36,571 |
6. Sale of GTC Common Stock
On April 4, 2002, GTC purchased approximately 2.8 million shares of GTC common stock held by us and allocated to Genzyme General for an aggregate consideration of $9.6 million. We received $4.8 million in cash and a promissory note for the remaining amount. The shares of GTC common stock sold were valued at $3.385 per share in this transaction, using the simple average of the high and low transaction prices quoted on the Nasdaq National Market on April 1, 2002. We have committed to a 24-month lock-up provision on the remaining 4.9 million shares of GTC common stock held by us and allocated to Genzyme General, which is approximately 17% of the shares of GTC common stock outstanding as of June 30, 2003. We accounted for our investment in GTC under the equity method of accounting until May 2002, at which point our ownership interest and board representation was reduced below 20% and we did not have any other factors of significant influence. Accordingly, we ceased to have significant influence over GTC and we began accounting for our investment in GTC under the cost method of accounting in June 2002. Equity in net loss of unconsolidated affiliates in our consolidated statements of operations and the combined statements of operations of Genzyme General includes charges of $1.0 million for the three months and $2.1 million for the six months ended June 30, 2002 representing our portion of the losses of GTC.
7. Investments in Equity Securities
At December 31, 2002, the remaining 4.9 million shares of GTC common stock that we held did not qualify as marketable securities under SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," because we were within the first 12 months of the 24-month lock-up provision
31
described above. As a result, we carried our investment in GTC on our consolidated balance sheets and the combined balance sheets of Genzyme General at cost, subject to review for impairment. Effective April 4, 2003, we began the last 12 months of the 24-month lock-up provision and, as a result, the remaining shares of GTC common stock that we hold now qualify as marketable securities under SFAS No. 115 and are carried on our consolidated balance sheets and the combined balance sheets of Genzyme General at fair value.
We review the carrying value of each of our strategic investments in equity securities on a quarterly basis for potential impairment. In June 2003, we recorded a $3.6 million impairment charge in connection with our investment in the common stock of ABIOMED because we considered the decline in value of this investment to be other than temporary. Given the significance and duration of the decline as of June 30, 2003, we concluded that it was unclear over what period the recovery of the stock price for this investment would take place, and, accordingly, what any evidence suggesting that the investment would recover to at least our historical cost was not sufficient to overcome the presumption that the current market price was the best indicator of the value of this investment.
At June 30, 2003, Genzyme General's division equity includes $16.4 million of unrealized gains and $0.3 million of unrealized losses related to our other investments in equity securities, all of which were allocated to Genzyme General. We believe the losses related to our other investments in equity securities are temporary.
8. Investment in Peptimmune, Inc.
In January 2002, we formed Peptimmune, as our wholly-owned subsidiary, by contributing $5.0 million of cash and $0.3 million of other assets to Peptimmune in exchange for 5.5 million shares of Peptimmune's Series A voting preferred stock and 100 shares of Peptimmune common stock. We allocated our investment in Peptimmune to Genzyme General. We consolidated the results of Peptimmune through February 2003 because during that period we owned 100% of its outstanding stock. In March 2003, our investment in Peptimmune decreased to approximately 12% as a result of the sale by Peptimmune of shares of its Series B voting preferred stock to third party investors. In accordance with our policy pertaining to affiliate sales of stock, we recorded a $2.9 million net gain ($4.5 million pre-tax) due to this sale, which was recorded as an increase to Genzyme General's investment in Peptimmune in other noncurrent assets and an increase to other comprehensive income in division equity in Genzyme General's combined balance sheet. Although our ownership interest in Peptimmune has declined below 20%, we account for our investment in Peptimmune under the equity method of accounting because certain factors exist that cause us to continue to have significant influence over Peptimmune, including that the chairman, president and chief executive officer of Peptimmune is a member of our board of directors, one of our corporate officers is a consultant to Peptimmune and we have service agreements with Peptimmune. Our equity in the net losses of Peptimmune have not been significant to date.
9. Other Commitments and Contingencies
We periodically become subject to legal proceedings and claims arising in connection with our business. We do not believe that there were any asserted claims against us as of June 30, 2003 which, if adversely decided, would have a material adverse effect on Genzyme General's results of operations,
32
financial condition or liquidity. For more information regarding legal proceedings and claims, we suggest that you read Note 11., "Other Commitments and Contingencies," to our consolidated financial statements. We incorporate that information into this note by reference.
Guarantees
In November 2002, the FASB issued FIN 45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Othersan interpretation of FASB Statements No. 5, 57 and 107 and rescission of FASB Interpretation No. 34." Genzyme General applied the disclosure provisions of FIN 45 as of December 31, 2002. For more information, we suggest that you read Note 11., "Other Commitments and ContingenciesGuarantees," to our consolidated financial statements. We incorporate that information into this note by reference.
10. Tax Provision
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||
Provision for income taxes | $ | (29,378 | ) | $ | (17,964 | ) | 64% | $ | (54,869 | ) | $ | (29,979 | ) | 83% | ||
Effective tax rate | 32 | % | 29 | % | 31 | % | 30 | % |
Genzyme General's tax rates for all periods presented vary from the United States statutory tax rate as a result of its:
11. Segment Information
In accordance with SFAS No. 131,"Disclosures about Segments of an Enterprise and Related Information," we present segment information for Genzyme General in a manner consistent with the method we use to report this information to our management. Applying SFAS No. 131, Genzyme General has three reportable segments:
33
We provide information concerning the operations of these reportable segments in the following table (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
|||||||||||
Revenues: | |||||||||||||||
Therapeutics | $ | 220,158 | $ | 173,933 | $ | 417,369 | $ | 335,240 | |||||||
Renal (1) | 66,002 | 39,543 | 124,768 | 69,075 | |||||||||||
Diagnostic Products | 22,554 | 20,530 | 45,750 | 40,368 | |||||||||||
Other (2) | 38,216 | 32,303 | 72,580 | 63,091 | |||||||||||
Eliminations/Adjustments (3) | 733 | 859 | 1,241 | 1,541 | |||||||||||
Total | $ | 347,663 | $ | 267,168 | $ | 661,708 | $ | 509,315 | |||||||
Division net income: | |||||||||||||||
Therapeutics | $ | 60,813 | $ | 43,349 | $ | 111,945 | $ | 75,191 | |||||||
Renal (1) | 5,368 | (4,503 | ) | 9,163 | (9,630 | ) | |||||||||
Diagnostic Products | 1,165 | 681 | 3,127 | (764 | ) | ||||||||||
Other (2) | 2,980 | 1,024 | 4,325 | 3,215 | |||||||||||
Eliminations/Adjustments (3) | (7,545 | ) | 3,860 | (7,986 | ) | 708 | |||||||||
Division net income | $ | 62,781 | $ | 44,411 | $ | 120,574 | $ | 68,720 | |||||||
34
Segment Assets
We provide information concerning the assets of Genzyme General's reportable segments in the following table (amounts in thousands):
|
June 30, 2003 |
December 31, 2002 |
||||||
---|---|---|---|---|---|---|---|---|
Segment Assets (1): | ||||||||
Therapeutics | $ | 1,037,674 | $ | 1,127,493 | ||||
Renal | 480,717 | 467,164 | ||||||
Diagnostic Products | 103,308 | 103,636 | ||||||
Other (2) | 95,136 | 89,705 | ||||||
Eliminations/Adjustments (3) | 2,109,811 | 1,767,803 | ||||||
Total | $ | 3,826,646 | $ | 3,555,801 | ||||
12. Subsequent Event
On August 13, 2003, we launched an all cash tender offer for all of the outstanding shares of SangStat for $22.50 per outstanding share, or approximately $600 million. The transaction, which we expect to be completed in September 2003, is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
35
GENZYME BIOSURGERY
A Division of Genzyme Corporation
Combined Statements of Operations
(Unaudited, amounts in thousands)
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 61,679 | $ | 57,224 | $ | 119,129 | $ | 105,387 | ||||||||
Net service sales | 6,192 | 5,604 | 13,235 | 10,812 | ||||||||||||
Revenues from research and development contracts | 887 | 35 | 2,020 | 35 | ||||||||||||
Total revenues | 68,758 | 62,863 | 134,384 | 116,234 | ||||||||||||
Operating costs and expenses: |
||||||||||||||||
Cost of products sold | 25,111 | 25,757 | 50,369 | 50,312 | ||||||||||||
Cost of services sold | 2,775 | 3,585 | 6,289 | 6,618 | ||||||||||||
Selling, general and administrative | 33,915 | 28,239 | 61,159 | 52,738 | ||||||||||||
Research and development (including research and development related to contracts) | 14,947 | 12,984 | 28,886 | 24,856 | ||||||||||||
Amortization of intangibles | 7,768 | 7,863 | 15,537 | 15,742 | ||||||||||||
Charge for impairment of goodwill | 102,792 | | 102,792 | | ||||||||||||
Charge for impaired asset | 2,898 | | 2,898 | | ||||||||||||
Total operating costs and expenses | 190,206 | 78,428 | 267,930 | 150,266 | ||||||||||||
Operating loss | (121,448 | ) | (15,565 | ) | (133,546 | ) | (34,032 | ) | ||||||||
Other income (expenses): |
||||||||||||||||
Loss on sale of product line | (29,367 | ) | | (29,367 | ) | | ||||||||||
Other | (5 | ) | 78 | (35 | ) | 111 | ||||||||||
Investment income | 253 | 326 | 472 | 623 | ||||||||||||
Interest expense | (1,987 | ) | (2,361 | ) | (4,180 | ) | (4,606 | ) | ||||||||
Total other expenses | (31,106 | ) | (1,957 | ) | (33,110 | ) | (3,872 | ) | ||||||||
Division net loss before cumulative effect of change in accounting for goodwill | (152,554 | ) | (17,522 | ) | (166,656 | ) | (37,904 | ) | ||||||||
Cumulative effect of change in accounting for goodwill | | | | (98,270 | ) | |||||||||||
Division net loss | $ | (152,554 | ) | $ | (17,522 | ) | $ | (166,656 | ) | $ | (136,174 | ) | ||||
Comprehensive loss, net of tax: | ||||||||||||||||
Division net loss | $ | (152,554 | ) | $ | (17,522 | ) | $ | (166,656 | ) | $ | (136,174 | ) | ||||
Other comprehensive income (loss), net of tax: | ||||||||||||||||
Foreign currency translation adjustments | 351 | 498 | 1,720 | (3,340 | ) | |||||||||||
Comprehensive loss | $ | (152,203 | ) | $ | (17,024 | ) | $ | (164,936 | ) | $ | (139,514 | ) | ||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
36
GENZYME BIOSURGERY
A Division of Genzyme Corporation
Combined Balance Sheets
(Unaudited, amounts in thousands)
|
June 30, 2003 |
December 31, 2002 |
||||||
---|---|---|---|---|---|---|---|---|
ASSETS | ||||||||
Current assets: |
||||||||
Cash and cash equivalents | $ | 26,949 | $ | 32,747 | ||||
Accounts receivable, net | 25,217 | 35,594 | ||||||
Inventories | 18,036 | 42,413 | ||||||
Prepaid expenses and other current assets | 2,610 | 2,015 | ||||||
Due from Teleflex | 32,767 | | ||||||
Total current assets | 105,579 | 112,769 | ||||||
Property, plant and equipment, net |
41,423 |
52,582 |
||||||
Goodwill, net | 7,584 | 110,376 | ||||||
Other intangible assets, net | 234,148 | 282,817 | ||||||
Investment in equity securities | 2,151 | | ||||||
Other noncurrent assets | 1,126 | 2,248 | ||||||
Total assets | $ | 392,011 | $ | 560,792 | ||||
LIABILITIES AND DIVISION EQUITY |
||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,282 | $ | 8,480 | ||||
Accrued expenses | 23,257 | 23,665 | ||||||
Due to Genzyme General | 29,178 | 32,641 | ||||||
Deferred revenue | 1,589 | 1,126 | ||||||
Current portion of long-term debt, convertible note and capital lease obligations | 300,325 | 294,724 | ||||||
Total current liabilities | 360,631 | 360,636 | ||||||
Due to Genzyme Generalnoncurrent |
8,443 |
9,390 |
||||||
Deferred revenuenoncurrent | | 1,771 | ||||||
Other noncurrent liabilities | 3,076 | 2,772 | ||||||
Total liabilities | 372,150 | 374,569 | ||||||
Commitments and contingencies (Notes 7, 9) |
||||||||
Division equity |
19,861 |
186,223 |
||||||
Total liabilities and division equity | $ | 392,011 | $ | 560,792 | ||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
37
GENZYME BIOSURGERY
A Division of Genzyme Corporation
Combined Statements of Cash Flows
(Unaudited, amounts in thousands)
|
Six Months Ended June 30, |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
|||||||||
Cash Flows from Operating Activities: | |||||||||||
Division net loss | $ | (166,656 | ) | $ | (136,174 | ) | |||||
Reconciliation of division net loss to net cash used in operating activities: | |||||||||||
Depreciation and amortization | 18,748 | 19,061 | |||||||||
Provision for bad debts | 338 | 371 | |||||||||
Charge for impairment of goodwill | 102,792 | | |||||||||
Charge for impaired asset | 2,898 | | |||||||||
Loss on sale of product line | 29,367 | | |||||||||
Other | (582 | ) | (109 | ) | |||||||
Cumulative effect of change in accounting for goodwill | | 98,270 | |||||||||
Increase (decrease) in cash from working capital changes: | |||||||||||
Accounts receivable | 4,719 | 1,831 | |||||||||
Inventories | 3,723 | 2,320 | |||||||||
Prepaid expenses and other current assets | (1,009 | ) | 165 | ||||||||
Accounts payable and accrued expenses | 477 | (5,711 | ) | ||||||||
Due to Genzyme General | (4,410 | ) | 1,947 | ||||||||
Cash flows from operating activities | (9,595 | ) | (18,029 | ) | |||||||
Cash Flows from Investing Activities: |
|||||||||||
Purchase of equity securities | (375 | ) | | ||||||||
Purchases of property, plant and equipment | (2,149 | ) | (1,931 | ) | |||||||
Purchase of technology rights | | (255 | ) | ||||||||
Other | 1,115 | 253 | |||||||||
Cash flows from investing activities | (1,409 | ) | (1,933 | ) | |||||||
Cash Flows from Financing Activities: |
|||||||||||
Allocated proceeds from issuance of Biosurgery Stock | 310 | 432 | |||||||||
Proceeds from draw on credit facility | 16,000 | 35,000 | |||||||||
Payments of debt and capital lease obligations | (10,399 | ) | (483 | ) | |||||||
Payment of NeuroCell refund to Genzyme General | | (27,063 | ) | ||||||||
Bank overdraft | (425 | ) | (312 | ) | |||||||
Other | 90 | 2,493 | |||||||||
Cash flows from financing activities | 5,576 | 10,067 | |||||||||
Effect of exchange rate changes on cash |
(370 |
) |
(1,560 |
) |
|||||||
Decrease in cash and cash equivalents |
(5,798 |
) |
(11,455 |
) |
|||||||
Cash and cash equivalents at beginning of period | 32,747 | 38,623 | |||||||||
Cash and cash equivalents at end of period | $ | 26,949 | $ | 27,168 | |||||||
Supplemental disclosure of non-cash transactions: |
|||||||||||
Investment in Excigen, Inc.Note 7. | |||||||||||
Disposition of Cardiac Devices business assetsNote 4. |
The accompanying notes are an integral part of these unaudited, combined financial statements.
38
GENZYME BIOSURGERY
A Division of Genzyme Corporation
Notes to Unaudited, Combined Financial Statements
1. Description of Business
Genzyme Biosurgery is our operating division that develops and markets biotherapeutic and biomaterial products, with an emphasis on products that meet medical needs in the orthopaedics, cardiovascular and broader surgical areas.
2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The unaudited, combined financial statements of Genzyme Biosurgery for each period include the statements of operations, balance sheets and statements of cash flows of the businesses we allocate to Genzyme Biosurgery. We also allocate a portion of our corporate operations to Genzyme Biosurgery using methods described in our allocation policy included in Note A., "Summary of Significant Accounting PoliciesAllocation Policy," to Genzyme Biosurgery's combined financial statements included in Exhibit 13.3 to our 2002 Form 10-K. These unaudited, combined financial statements are prepared using amounts included in our unaudited, consolidated financial statements included in this Form 10-Q. We prepared these unaudited, combined financial statements for Genzyme Biosurgery following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States. We have reclassified certain 2002 data to conform to our 2003 presentation.
These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of Genzyme Biosurgery's financial position and operating results. Since these are interim financial statements, you should also read the combined financial statements and notes for Genzyme Biosurgery included in our 2002 Form 10-K.
Elimination of Tracking Stock Structure
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock. Options and warrants to purchase shares of Biosurgery Stock were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock, no shares remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery are now allocated to Genzyme General. We have deregistered Biosurgery Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangement previously approved by our board of directors that had made a portion of Genzyme General's cash available to Genzyme Biosurgery. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and notes thereto for Genzyme Biosurgery but will continue to provide our consolidated financial statements and notes thereto for our corporation as a whole.
39
Accounting for Stock-Based Compensation
In accounting for stock-based compensation, we do not recognize compensation expense for options granted under the provisions of our stock-based compensation plans with fixed terms and an exercise price greater than or equal to the fair market value of the underlying series of our common stock on the date of grant. All stock-based awards to non-employees are accounted for at their fair value in accordance with SFAS No. 123, "Accounting for Stock-Based Compensation," as amended, and EITF Issue No. 96-18, "Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services."
In accordance with the disclosure requirements of SFAS No. 148, "Accounting for Stock-Based CompensationTransition and Disclosurean amendment of FASB Statement No. 123," the following table sets forth Genzyme Biosurgery's division net loss data as if compensation expense for our stock-based compensation plans was determined in accordance with SFAS No. 123, as amended, based on the fair value at the grant dates of the awards (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||
Division net loss: | ||||||||||||||
As reported | $ | (152,554 | ) | $ | (17,522 | ) | $ | (166,656 | ) | $ | (136,174 | ) | ||
Deduct: pro forma stock-based compensation expense, net of tax | (1,127 | ) | (2,559 | ) | (2,408 | ) | (3,809 | ) | ||||||
Pro forma | $ | (153,681 | ) | $ | (20,081 | ) | $ | (169,064 | ) | $ | (139,983 | ) | ||
Recent Accounting Pronouncements
We have included the impact that recently issued accounting standards will have on our financial statements in Note 2., "Basis of Presentation and Significant Accounting PoliciesRecent Accounting Pronouncements," to our consolidated financial statements, which we incorporate by reference into this note.
3. Net Income (Loss) Per Share
Note 3., "Net Income (Loss) Per Share," to our consolidated financial statements contains information regarding the calculation of earnings per share for each series of our stock using the two-class method. We present earnings per share data only in our consolidated financial statements because Genzyme Corporation is the issuer of the securities. Our divisions do not and cannot issue securities because they are not companies or legal entities.
4. Disposition of Cardiac Devices Business Assets and Charge for Impaired Asset
On June 30, 2003, we sold substantially all of the tangible and intangible assets directly associated with our cardiac devices business, excluding our Fall River, Massachusetts manufacturing facility, the assets related to our FocalSeal product line and certain other assets, to Teleflex for $32.8 million in cash. In addition, Teleflex assumed $6.3 million of trade obligations directly associated with our cardiac
40
devices business. The sale was completed on June 30, 2003 after banking hours and, as a result, the proceeds were not received until July 1, 2003. We recorded the proceeds as a receivable due from Teleflex in our consolidated balance sheet and the combined balance sheet of Genzyme Biosurgery at June 30, 2003. The assets sold had a net carrying value of $68.1 million at the time of the sale. We recorded a net loss of $29.4 million in our consolidated statements of operations and in the combined statements of operations of Genzyme Biosurgery in June 2003 in connection with this sale. Teleflex is leasing the manufacturing facility that we own in Fall River, Massachusetts through December 2004 with an option to extend the term to June 30, 2005. We have also entered into several transitional services agreements with Teleflex under which we will each provide and receive certain services for specified periods of time and fees as described in the agreements.
In connection with the sale of assets to Teleflex, we tested the carrying value of our manufacturing facility in Fall River, Massachusetts in June 2003 to determine whether the impairment recognition criteria in SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," had been met. In evaluating the facility for impairment, we considered the risks associated with the eventual sale of this facility, including the probability of finding a buyer for the facility, the amount of time that would likely be required to market and complete the sale of the facility and the estimated range of net proceeds that we could expect to receive. Our impairment analysis indicated that the carrying value for the Fall River facility would not be fully recoverable. As a result of this assessment, we recorded an estimated charge for impaired asset of $2.9 million in our consolidated statements of operations and the combined statements of operations for Genzyme Biosurgery in June 2003 to write down the carrying value of the Fall River facility to its estimated fair value.
5. Inventories
|
June 30, 2003 |
December 31, 2002 |
|||||
---|---|---|---|---|---|---|---|
|
(Amounts in thousands) |
||||||
Raw materials | $ | 4,619 | $ | 11,817 | |||
Work-in-process | 5,135 | 8,833 | |||||
Finished products | 8,282 | 21,763 | |||||
Total | $ | 18,036 | $ | 42,413 | |||
In June 2003, we sold $21.3 million of inventory related to our cardiac devices business to Teleflex.
6. Goodwill and Other Intangible Assets
Effective January 1, 2002, Genzyme Biosurgery adopted SFAS No. 142, "Goodwill and Other Intangible Assets," which requires that ratable amortization of goodwill and certain intangible assets be replaced with periodic tests of goodwill's impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. We are required to perform impairment tests under SFAS No. 142 annually, which we perform in the third quarter, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable.
41
Cumulative Effect of Change in Accounting for Goodwill
Upon adoption of SFAS No. 142, we tested the goodwill of Genzyme Biosurgery's cardiothoracic reporting unit in accordance with the transitional provisions of that standard, using the present value of expected future cash flows to estimate the fair value of this reporting unit. We recorded an impairment charge of $98.3 million, which we reflected as a cumulative effect of a change in accounting for goodwill in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery in March 2002.
Goodwill
Effective January 1, 2002, in accordance with the provisions of SFAS No. 142, Genzyme Biosurgery ceased amortizing goodwill. The following table provides information on the changes in net goodwill attributable to Genzyme Biosurgery's reporting segments during the six months ended June 30, 2003 (amounts in thousands):
|
As of December 31, 2002 |
Impairment |
As of June 30, 2003 |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Goodwill: | ||||||||||||
Orthopaedics (1) | $ | 113,857 | $ | (113,857 | ) | $ | | |||||
Biosurgical Specialties | 8,414 | | 8,414 | |||||||||
Total | 122,271 | (113,857 | ) | 8,414 | ||||||||
Accumulated amortization (1) | (11,895 | ) | 11,065 | (830 | ) | |||||||
Goodwill, net | $ | 110,376 | $ | (102,792 | ) | $ | 7,584 | |||||
42
Other Intangible Assets
The following table contains information on Genzyme Biosurgery's other intangible assets for the periods presented (amounts in thousands):
|
As of June 30, 2003 |
As of December 31, 2002 |
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
Gross Other Intangible Assets |
Accumulated Amortization |
Net Other Intangible Assets |
||||||||||||
Technology | $ | 173,379 | $ | (39,830 | ) | $ | 133,549 | $ | 173,379 | $ | (31,928 | ) | $ | 141,451 | ||||
Patents (1) | 66,799 | (15,821 | ) | 50,978 | 79,423 | (20,151 | ) | 59,272 | ||||||||||
Trademarks (1) | 51,501 | (11,927 | ) | 39,574 | 85,228 | (15,055 | ) | 70,173 | ||||||||||
License fees (1) | | | | 890 | (147 | ) | 743 | |||||||||||
Distribution agreement | 13,950 | (4,422 | ) | 9,528 | 13,950 | (3,550 | ) | 10,400 | ||||||||||
Other | 1,557 | (1,038 | ) | 519 | 2,197 | (1,419 | ) | 778 | ||||||||||
Total | $ | 307,186 | $ | (73,038 | ) | $ | 234,148 | $ | 355,067 | $ | (72,250 | ) | $ | 282,817 | ||||
All of Genzyme Biosurgery's other intangible assets are amortized over their estimated useful lives, which range from 3 years to 12 years. Total amortization expense for Genzyme Biosurgery's other intangible assets was:
The estimated future amortization expense for Genzyme Biosurgery's other intangible assets as of June 30, 2003 for the remainder of fiscal year 2003 and the five succeeding fiscal years is as follows (amounts in thousands):
Year Ended December 31, |
Estimated Amortization Expense |
||
---|---|---|---|
2003 (remaining six months) | $ | 14,551 | |
2004 | 28,781 | ||
2005 | 28,522 | ||
2006 | 28,522 | ||
2007 | 28,522 | ||
2008 | 28,459 |
43
7. Investment in Excigen, Inc.
In March 2003, we entered into a collaboration with Excigen, Inc., or Excigen, a recently created biotechnology company in Baltimore, Maryland focused on developing gene therapies for treating cardiac arrhythmias. In connection with the collaboration, we acquired 1,440,000 shares of the convertible preferred stock of Excigen and a warrant to acquire an additional 865,882 shares of convertible preferred stock, in exchange for our commitment to provide Excigen with up to $2.3 million in funding and $2.3 million worth of research, clinical, regulatory and manufacturing services. We provided the initial $0.4 million of the cash commitment in March 2003, with the balance of $1.9 million to be paid in future installments. We allocate our ownership interest in Excigen to Genzyme Biosurgery. As a result of our ownership interest, we account for our investment in Excigen under the equity method of accounting. During the three and six months ended June 30, 2003, Genzyme Biosurgery did not record any significant change in the equity in net loss of Excigen, which is included in research and development expense.
8. Revolving Credit Facility and Convertible Note
Genzyme Biosurgery has access to a $350.0 million revolving credit facility, all of which matures in December 2003. During the second quarter of 2003, we drew down $16.0 million under this facility and allocated the proceeds to Genzyme Biosurgery. At June 30, 2003, $300.0 million remained outstanding under this facility, all of which was repaid on August 11, 2003. Borrowings under this facility bear interest at LIBOR plus an applicable margin, which was, in aggregate, 2.5% at June 30, 2003. We intend to refinance our revolving credit facility prior to its expiration in December 2003.
In May 2003, we used $10.0 million cash allocated to Genzyme Biosurgery to satisfy the 6.9% convertible subordinated note assumed upon our acquisition of Biomatrix.
9. Other Commitments and Contingencies
We periodically become subject to legal proceedings and claims arising in connection with our business. We do not believe that there were any asserted claims against us as of June 30, 2003 which, if adversely decided, would have a material adverse effect on Genzyme Biosurgery's results of operations, financial condition or liquidity. For more information regarding legal proceedings and claims, we suggest that you read Note 11., "Other Commitments and Contingencies," to our consolidated financial statements. We incorporate that information into this note by reference.
Guarantees
In November 2002, the FASB issued FIN 45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Othersan interpretation of FASB Statements No. 5, 57 and 107 and rescission of FASB Interpretation No. 34." Genzyme Biosurgery applied the disclosure provisions of FIN 45 as of December 31, 2002. For more information, we suggest that you read Note 11., "Other Commitments and ContingenciesGuarantees," to our consolidated financial statements. We incorporate that information into this note by reference.
44
10. Segment Information
In accordance with SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information," we present segment information for Genzyme Biosurgery in a manner consistent with the method we use to report this information to our management. Applying SFAS No. 131, Genzyme Biosurgery has four reportable segments:
We provide information concerning the operations of these reportable segments in the following table (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||
Revenues: | ||||||||||||||
Orthopaedics | $ | 35,280 | $ | 30,530 | $ | 68,131 | $ | 54,705 | ||||||
Biosurgical Specialties | 13,850 | 12,600 | 27,613 | 23,622 | ||||||||||
Cardiac Science (1) | 139 | | 171 | | ||||||||||
Cardiac Devices (1) | 19,489 | 19,733 | 38,469 | 37,907 | ||||||||||
Total | $ | 68,758 | $ | 62,863 | $ | 134,384 | $ | 116,234 | ||||||
Gross Margin: |
||||||||||||||
Orthopaedics | $ | 26,429 | $ | 21,719 | $ | 49,661 | $ | 36,904 | ||||||
Biosurgical Specialties | 8,129 | 6,062 | 15,024 | 11,533 | ||||||||||
Cardiac Science (1,2) | (357 | ) | | (827 | ) | | ||||||||
Cardiac Devices (1,2) | 6,671 | 5,740 | 13,868 | 10,867 | ||||||||||
Total | $ | 40,872 | $ | 33,521 | $ | 77,726 | $ | 59,304 | ||||||
Segment Assets
Except for intangible assets, we do not allocate assets within Genzyme Biosurgery for purposes of segment information.
45
GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
Combined Statements of Operations
(Unaudited, amounts in thousands)
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
|||||||||||
Revenues: | |||||||||||||||
Service revenue | $ | 37 | $ | 185 | $ | 37 | $ | 485 | |||||||
Revenue from research and development contracts | 1,777 | 1,469 | 3,254 | 2,938 | |||||||||||
Licensing revenue | 661 | 673 | 1,365 | 1,326 | |||||||||||
Royalty revenue | 7 | 19 | 14 | 19 | |||||||||||
Total revenues | 2,482 | 2,346 | 4,670 | 4,768 | |||||||||||
Operating costs and expenses: |
|||||||||||||||
Cost of services sold | 17 | 168 | 17 | 287 | |||||||||||
Cost of revenue from research and development contracts, licensing and royalty revenue | 1,156 | 1,167 | 2,328 | 2,302 | |||||||||||
Selling, general and administrative | 1,689 | 2,124 | 3,423 | 4,193 | |||||||||||
Research and development | 4,126 | 5,323 | 8,317 | 10,621 | |||||||||||
Total operating costs and expenses | 6,988 | 8,782 | 14,085 | 17,403 | |||||||||||
Operating loss | (4,506 | ) | (6,436 | ) | (9,415 | ) | (12,635 | ) | |||||||
Other income (expenses): |
|||||||||||||||
Investment income | 117 | 219 | 231 | 407 | |||||||||||
Interest expense | (20 | ) | (20 | ) | (40 | ) | (40 | ) | |||||||
Total other income (expenses) | 97 | 199 | 191 | 367 | |||||||||||
Division net loss | $ | (4,409 | ) | $ | (6,237 | ) | $ | (9,224 | ) | $ | (12,268 | ) | |||
Comprehensive income (loss), net of tax: |
|||||||||||||||
Division net loss | $ | (4,409 | ) | $ | (6,237 | ) | $ | (9,224 | ) | $ | (12,268 | ) | |||
Other comprehensive income (loss), net of tax: | |||||||||||||||
Foreign currency translation adjustments | 1 | (2 | ) | 2 | (1 | ) | |||||||||
Unrealized gains (losses) on securities, net of tax | (86 | ) | 171 | (133 | ) | 79 | |||||||||
Other comprehensive income (loss) | (85 | ) | 169 | (131 | ) | 78 | |||||||||
Comprehensive loss | $ | (4,494 | ) | $ | (6,068 | ) | $ | (9,355 | ) | $ | (12,190 | ) | |||
The accompanying notes are an integral part of these unaudited, combined financial statements.
46
GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
Combined Balance Sheets
(Unaudited, amounts in thousands)
|
June 30, 2003 |
December 31, 2002 |
||||||
---|---|---|---|---|---|---|---|---|
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 825 | $ | 1,459 | ||||
Short-term investments | | 11,653 | ||||||
Accounts receivable, net | 355 | 229 | ||||||
Prepaid expenses and other current assets | 419 | 614 | ||||||
Total current assets | 1,599 | 13,955 | ||||||
Equipment, net |
11 |
26 |
||||||
Total assets | $ | 1,610 | $ | 13,981 | ||||
LIABILITIES AND DIVISION EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accrued expenses | $ | 606 | $ | 760 | ||||
Due to Genzyme General | 4,855 | 5,494 | ||||||
Deferred revenue | 1,805 | 4,173 | ||||||
Total liabilities | 7,266 | 10,427 | ||||||
Commitments and contingencies (Note 4) |
||||||||
Division equity (deficit) |
(5,656 |
) |
3,554 |
|||||
Total liabilities and division equity (deficit) | $ | 1,610 | $ | 13,981 | ||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
47
GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
Combined Statements of Cash Flows
(Unaudited, amounts in thousands)
|
Six Months Ended June 30, |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
|||||||||
Cash Flows from Operating Activities: | |||||||||||
Division net loss | $ | (9,224 | ) | $ | (12,268 | ) | |||||
Reconciliation of division net loss to net cash used in operating activities: | |||||||||||
Depreciation | 15 | 60 | |||||||||
Other | (22 | ) | (68 | ) | |||||||
Increase (decrease) in cash from working capital changes: | |||||||||||
Accounts receivable | (126 | ) | 438 | ||||||||
Prepaid expenses and other current assets | 195 | 106 | |||||||||
Accrued expenses and deferred revenue | (2,522 | ) | (3,072 | ) | |||||||
Due to Genzyme General | (639 | ) | (1,186 | ) | |||||||
Cash flows from operating activities | (12,323 | ) | (15,990 | ) | |||||||
Cash Flows from Investing Activities: |
|||||||||||
Purchases of investments | | (21,444 | ) | ||||||||
Sales and maturities of investments | 11,544 | 1,519 | |||||||||
Cash flows from investing activities | 11,544 | (19,925 | ) | ||||||||
Cash Flows from Financing Activities: |
|||||||||||
Allocated proceeds from issuance of Molecular Oncology Stock | 142 | 184 | |||||||||
Cash flows from financing activities | 142 | 184 | |||||||||
Effect of exchange rate changes on cash |
3 |
(1 |
) |
||||||||
Decrease in cash and cash equivalents | (634 | ) | (35,732 | ) | |||||||
Cash and cash equivalents at beginning of period | 1,459 | 41,135 | |||||||||
Cash and cash equivalents at end of period | $ | 825 | $ | 5,403 | |||||||
The accompanying notes are an integral part of these unaudited, combined financial statements.
48
GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
Notes To Unaudited, Combined Financial Statements
1. Business Description
Genzyme Molecular Oncology is our operating division that is developing a new generation of cancer products focused on cancer vaccines and angiogenesis inhibitors through the integration of its genomics, gene and cell therapy, small molecule drug discovery and protein therapeutic capabilities.
2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The unaudited, combined financial statements of Genzyme Molecular Oncology for each period include the statements of operations, balance sheets and statements of cash flows of the businesses we allocate to Genzyme Molecular Oncology. We also allocate a portion of our corporate operations to Genzyme Molecular Oncology using methods described in our allocation policy included in Note A., "Summary of Significant Accounting PoliciesAllocation Policy," to Genzyme Molecular Oncology's combined financial statements included in Exhibit 13.4 to our 2002 Form 10-K. These unaudited, combined financial statements are prepared using amounts included in our unaudited, consolidated financial statements included in this Form 10-Q. We prepared these unaudited, combined financial statements for Genzyme Molecular Oncology following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States.
These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of Genzyme Molecular Oncology's financial position and operating results. Since these are interim financial statements, you should also read the financial statements and notes for Genzyme Molecular Oncology included in our 2002 Form 10-K.
Elimination of Tracking Stock Structure
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options to purchase shares of Molecular Oncology Stock were converted into options to purchase shares of Genzyme General Stock. While our charter continues to designate 40,000,000 shares as Molecular Oncology Stock, no shares remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangements previously approved by our board of directors that had made a portion of Genzyme General's cash available to Genzyme Molecular Oncology. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and notes thereto for Genzyme Molecular Oncology but will continue to provide our consolidated financial statements and notes thereto for our corporation as a whole.
49
Accounting for Stock-Based Compensation
In accounting for stock-based compensation, we do not recognize compensation expense for options granted under the provisions of our stock-based compensation plans with fixed terms and an exercise price greater than or equal to the fair market value of the underlying series of our common stock on the date of grant. All stock-based awards to non-employees are accounted for at their fair value in accordance with SFAS No. 123, "Accounting for Stock-Based Compensation," as amended, and EITF Issue No. 96-18, "Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services."
In accordance with the disclosure requirements of SFAS No. 148, "Accounting for Stock-Based CompensationTransition and Disclosurean amendment of FASB Statement No. 123," the following table sets forth Genzyme Molecular Oncology's division net loss data as if compensation expense for our stock-based compensation plans was determined in accordance with SFAS No. 123, as amended, based on the fair value at the grant dates of the awards (amounts in thousands):
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2003 |
2002 |
2003 |
2002 |
||||||||||
Division net loss: | ||||||||||||||
As reported | $ | (4,409 | ) | $ | (6,237 | ) | $ | (9,224 | ) | $ | (12,268 | ) | ||
Deduct: pro forma stock-based compensation expense, net of tax | (745 | ) | (1,204 | ) | (1,463 | ) | (2,018 | ) | ||||||
Pro forma | $ | (5,154 | ) | $ | (7,441 | ) | $ | (10,687 | ) | $ | (14,286 | ) | ||
Recent Accounting Pronouncements
We have included the impact that recently issued accounting standards will have on our financial statements in Note 2., "Basis of Presentation and Significant Accounting PoliciesRecent Accounting Pronouncements," to our consolidated financial statements, which we incorporate by reference into this note.
3. Net Income (Loss) Per Share
Note 3., "Net Income (Loss) Per Share," to our consolidated financial statements contains information regarding the calculation of earnings per share for each series of our stock using the two-class method. We present earnings per share data only in our consolidated financial statements because Genzyme Corporation is the issuer of the securities. Our divisions do not and cannot issue securities because they are not companies or legal entities.
4. Other Commitments and Contingencies
We periodically become subject to legal proceedings and claims arising in connection with our business. We do not believe that there were any asserted claims against us as of June 30, 2003 which, if adversely decided, would have a material adverse effect on Genzyme Molecular Oncology's results of operations, financial condition or liquidity.
50
Guarantees
In November 2002, the FASB issued FIN 45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Othersan interpretation of FASB Statements No. 5, 57 and 107 and rescission of FASB Interpretation No. 34." Genzyme Molecular Oncology applied the disclosure provisions of FIN 45 as of December 31, 2002. For more information, we suggest that you read Note 11., "Other Commitments and ContingenciesGuarantees," to our consolidated financial statements. We incorporate that information into this note by reference.
51
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under "Factors Affecting Future Operating Results" below. These risks and uncertainties could cause our actual results to differ materially from those forecast in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward-looking statements under "Note Regarding Forward- Looking Statements." These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.
INTRODUCTION
We are a biotechnology and human healthcare company that develops innovative products and provides services for major unmet medical needs. We have three operating divisions:
Through June 30, 2003, we had three outstanding series of common stockGenzyme General Division common stock, which we refer to as "Genzyme General Stock," Genzyme Biosurgery Division common stock, which we refer to as "Biosurgery Stock," and Genzyme Molecular Oncology Division common stock, which we refer to as "Molecular Oncology Stock." We also refer to these series of stock as "tracking stock." Unlike typical common stock, each of our tracking stocks was designed to reflect the value and track the financial performance of a specific subset of our business operations and its allocated assets, rather than the operations and assets of our entire company.
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock,
52
were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all of our assets and liabilities are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions.
Prior to July 1, 2003, the chief mechanisms intended to cause each tracking stock to "track" the financial performance of each division were provisions in our charter governing dividends and distributions. The provisions governing dividends provided that our board of directors had discretion to decide if and when to declare dividends, subject to certain limitations. To the extent that the following amount did not exceed the funds that would be legally available for dividends under Massachusetts law, the dividend limit for a stock corresponding to a division was the greater of:
The provisions in our charter governing dividends and distributions factored the assets and liabilities and income or losses attributable to a division into the determination of the amount available to pay dividends on the associated tracking stock. In addition, our income tax allocation policy provided that if, at the end of any fiscal quarter, a division could not use any projected annual tax benefit attributable to it to offset or reduce its current or deferred income tax expense, we could allocate the tax benefit to other divisions in proportion to their taxable income without any compensating payments or allocation to the division generating the benefit. Through June 30, 2003, Genzyme Biosurgery and Genzyme Molecular Oncology have not generated taxable income, and thus have not had the ability to use any projected annual tax benefits. Genzyme General has generated taxable income, providing it with the ability to utilize the tax benefits generated by Genzyme Biosurgery and Genzyme Molecular Oncology. Consistent with our policy, we have allocated the tax benefits generated by Genzyme Biosurgery and Genzyme Molecular Oncology through June 30, 2003 to Genzyme General without making any compensating payments or allocations to the division that generated the benefit.
Deferred tax assets and liabilities can arise from purchase accounting and relate to a division that does not satisfy the realizability criteria of SFAS No. 109, "Accounting for Income Taxes." Prior to July 1, 2003, such deferred tax assets and liabilities were allocated to the division to which the acquisition was allocated. As a result, the periodic changes in these deferred tax assets and liabilities did not result in a tax expense or benefit to that division. However, the change in these deferred tax assets and liabilities impacted our consolidated tax provision. These changes were added to division net income for purposes of determining net income allocated to a tracking stock. Within these parameters, and other general limits under our charter and Massachusetts law, the amount of any dividend payment will be at the board of directors' discretion. To date, we have never paid or declared a cash dividend on shares of any of our series of common stock, nor do we anticipate paying or declaring a cash dividend on shares of Genzyme General Stock in the foreseeable future. Unless declared, no dividends will accrue on Genzyme General Stock.
Through June 30, 2003, to determine earnings per share, we allocated our earnings to each series of our common stock based on the earnings attributable to that series of stock. The earnings attributable to each series of stock was defined in our charter as the net income or loss of the
53
corresponding division determined in accordance with accounting principles generally accepted in the United States and as adjusted for tax benefits allocated to or from that division in accordance with management and accounting policies. Our charter also required that all of our income and expenses be allocated among our divisions in a reasonable and consistent manner. Because the earnings allocated to each series of stock are based on the income or losses attributable to each corresponding division, through June 30, 2003, we provided financial statements and management's discussion and analysis for our corporation as well as for each of our divisions to aid investors in evaluating our performance and the performance of each of our divisions.
While each tracking stock was designed to reflect a division's performance, each was common stock of Genzyme Corporation and not of a division. Our divisions were not separate companies or legal entities and therefore did not and could not issue stock. Holders of tracking stock had no specific rights to assets allocated to the corresponding division. We continued to hold title to all of the assets allocated to the corresponding division and were responsible for all of its liabilities, regardless of what we deemed for financial statement presentation purposes as allocated to any division. Holders of each tracking stock, as common stockholders were, therefore, subject to the risks of investing in the businesses, assets and liabilities of Genzyme as a whole. For instance, the assets allocated to each division were subject to company-wide claims of creditors, product liability plaintiffs and stockholder litigation. Also, in the event of a Genzyme liquidation, insolvency or similar event, holders of each tracking stock only had the rights of common stockholders in the combined assets of Genzyme.
Effective July 1, 2003, in connection with the elimination of our tracking stock structure, we will cease allocating earnings to Biosurgery Stock and Molecular Oncology Stock. From that date forward, all of our earnings will be allocated to Genzyme General Stock. Earnings allocated to Biosurgery Stock and Molecular Oncology Stock prior to July 1, 2003 will remain allocated to those stocks and will not be affected by the elimination of our tracking stock structure. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and management's discussion and analysis for each of our divisions but will continue to provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES
Our critical accounting policies are set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of OperationsCritical Accounting Policies and Significant Estimates" in Exhibit 13.1 to our 2002 Form 10-K. There have been no changes to these policies and no significant changes to these estimates since December 31, 2002.
DISPOSITION
On June 30, 2003, we sold substantially all of the tangible and intangible assets directly associated with our cardiac devices business, excluding our Fall River, Massachusetts manufacturing facility, the assets related to our FocalSeal product line and certain other assets, to Teleflex for $32.8 million in cash. In addition, Teleflex assumed $6.3 million of trade obligations directly associated with our cardiac devices business. The sale was completed on June 30, 2003 after banking hours and, as a result, the proceeds were not received until July 1, 2003. We recorded the proceeds as a receivable due from Teleflex in our consolidated balance sheet and the combined balance sheet of Genzyme Biosurgery at June 30, 2003. The assets sold had a net carrying value of $68.1 million at the time of the sale. We recorded a net loss of $29.4 million in our consolidated statements of operations and in the combined statements of operations of Genzyme Biosurgery in June 2003 in connection with this sale. We also recorded a tax benefit of $9.2 million for the reversal of related deferred tax liabilities, which was recorded in our consolidated statements of operations and allocated to Biosurgery Stock. Teleflex is
54
leasing the manufacturing facility that we own in Fall River, Massachusetts through December 2004 with an option to extend the term to June 30, 2005. We have also entered into several transitional services agreements with Teleflex under which we will each provide and receive certain services for specified periods of time and fees as described in the agreements.
The following discussion summarizes the key factors our management believes are necessary for an understanding of our consolidated financial statements.
GENZYME CORPORATION
REVENUES
The components of our total revenues are described in the following table:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Product revenue | $ | 383,232 | $ | 299,980 | 28 | % | $ | 729,721 | $ | 566,606 | 29 | % | ||||||
Service revenue | 31,550 | 28,024 | 13 | % | 63,048 | 54,707 | 15 | % | ||||||||||
Total product and service revenue | 414,782 | 328,004 | 26 | % | 792,769 | 621,313 | 28 | % | ||||||||||
Research and development revenue | 4,121 | 4,188 | (2 | )% | 7,993 | 8,819 | (9 | )% | ||||||||||
Total revenues | $ | 418,903 | $ | 332,192 | 26 | % | $ | 800,762 | $ | 630,132 | 27 | % | ||||||
Product Revenue
We derive product revenue from sales by:
55
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||||
Genzyme General: | ||||||||||||||||||||
Therapeutics: | ||||||||||||||||||||
Cerezyme enzyme | $ | 184,724 | $ | 154,717 | 19 | % | $ | 351,911 | $ | 302,783 | 16 | % | ||||||||
Other therapeutic products | 35,433 | 18,083 | 96 | % | 65,457 | 29,528 | 122 | % | ||||||||||||
Total Therapeutics | 220,157 | 172,800 | 27 | % | 417,368 | 332,311 | 26 | % | ||||||||||||
Renal |
66,002 |
39,543 |
67 |
% |
124,768 |
69,075 |
81 |
% |
||||||||||||
Diagnostic Products | 22,554 | 20,530 | 10 | % | 45,750 | 40,368 | 13 | % | ||||||||||||
Other | 12,840 | 9,883 | 30 | % | 22,706 | 19,465 | 17 | % | ||||||||||||
Total product revenueGenzyme General | 321,553 | 242,756 | 32 | % | 610,592 | 461,219 | 32 | % | ||||||||||||
Genzyme Biosurgery: |
||||||||||||||||||||
Orthopaedics | 29,633 | 25,767 | 15 | % | 55,987 | 45,765 | 22 | % | ||||||||||||
Biosurgical Specialties | 12,514 | 11,724 | 7 | % | 24,618 | 21,714 | 13 | % | ||||||||||||
Cardiac Science | 44 | | N/A | 56 | | N/A | ||||||||||||||
Cardiac Devices | 19,488 | 19,733 | (1 | )% | 38,468 | 37,908 | 1 | % | ||||||||||||
Total product revenueGenzyme Biosurgery | 61,679 | 57,224 | 8 | % | 119,129 | 105,387 | 13 | % | ||||||||||||
Total product revenue | $ | 383,232 | $ | 299,980 | 28 | % | $ | 729,721 | $ | 566,606 | 29 | % | ||||||||
Genzyme GeneralTherapeutics
The increase in our Therapeutics product revenue for the three and six months ended June 30, 2003, as compared to the same periods of 2002, is primarily due to continued growth in sales of Cerezyme enzyme and increased sales of other therapeutic products. Other therapeutic products revenue consists primarily of:
The growth in sales of Cerezyme enzyme for the three and six months ended June 30, 2003, as compared to the same periods of 2002, is attributable to our continued identification of new Gaucher disease patients worldwide, particularly in Europe, resulting from a significant investment in our global sales and marketing infrastructure. The growth in sales of Cerezyme enzyme for both periods was also positively impacted by the weakened U.S. Dollar against the Euro. During the three months ended June 30, 2003, the U.S. Dollar weakened against the Euro on average by 24%, as compared to the same period of 2002, which positively impacted sales by $12.8 million. During the six months ended June 30, 2003, the U.S. Dollar weakened against the Euro on average by 23%, as compared to the same period of 2002, which positively impacted sales by $23.3 million. Sales of Cerezyme enzyme are approximately 48% of our total product revenue for the three months ended June 30, 2003, as
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compared to 52% for the same period of 2002. Sales of Cerezyme enzyme are approximately 48% of our total product revenue for the six months ended June 30, 2003, as compared to 53% for the same period of 2002.
Our results of operations are highly dependent on sales of Cerezyme enzyme and a reduction in revenue from sales of this product would adversely affect its results of operations. Revenue from Cerezyme enzyme would be impacted negatively if competitors developed alternative treatments for Gaucher disease and the alternative products gained commercial acceptance. Although orphan drug status for Cerezyme enzyme, which provided us with exclusive marketing rights for Cerezyme enzyme in the United States, expired in May 2001, we continue to have patents protecting our method of manufacturing Cerezyme enzyme until 2010 and the composition of Cerezyme enzyme as made by that process until 2013. The expiration of market exclusivity and orphan drug status will likely subject Cerezyme enzyme to increased competition, which may decrease the amount of revenue we receive from this product or the growth of that revenue.
We are aware of companies that have initiated efforts to develop competitive products, and other companies may do so in the future. For example, Celltech Group plc and Actelion Ltd are developing Zavesca®, a small molecule drug candidate for the treatment of Type 1 Gaucher disease. Zavesca has been approved by both the FDA and the European Commission as an oral therapy for use in patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. Celltech/Actelion will be required to submit follow-up safety data on the product as a condition of these approvals. Zavesca has also been approved by the Israeli Ministry of Health. Teva Pharmaceuticals Industries Ltd., or Teva Pharmaceuticals, a licensee of Celltech, has the rights to Zavesca in Israel. To date, virtually all Gaucher disease patients who have received enzyme therapy have experienced strong clinical benefit with few side effects so we do not expect the competition from Zavesca to have a significant impact on our sales of Cerezyme enzyme.
The increase in other therapeutic products revenue for the three months ended June 30, 2003, as compared to the same period of 2002, is attributable to:
On April 24, 2003, the FDA granted marketing approval for Fabrazyme enzyme for Fabry disease. Fabrazyme enzyme has received orphan drug status, which provides seven years of market exclusivity in the United States. We have agreed with the FDA on a number of post-marketing commitments as a condition of this approval. If we fail to meet these commitments, our ability to continue marketing Fabrazyme enzyme in the United States may be adversely affected.
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The increase in other therapeutic products revenue for the six months ended June 30, 2003, as compared to the same period of 2002, is attributable to:
Genzyme GeneralRenal
In September 2002, we created the Renal reporting segment consisting primarily of amounts attributable to the manufacture and sale of Renagel phosphate binder. Previously, amounts attributable to the manufacture and sale of Renagel phosphate binder had been included as a component of our Therapeutics reporting segment. We have reclassified our 2002 disclosures to conform to the 2003 presentation. We expect sales of Renagel phosphate binder to increase, driven primarily by the continued adoption of the product by nephrologists worldwide. Our ability to continue to increase sales of Renagel phosphate binder will be dependent on several factors including:
During the three months ended March 31, 2003, we obtained reimbursement approval for the 800 mg tablet formulation of Renagel phosphate binder in France, the last major European market where this form of the product had previously been unavailable. In addition, in March 2003, we began shipping Renagel phosphate binder tablets to the European market from our new Current Good Manufacturing Practices, or cGMP, manufacturing facility in Waterford, Ireland, upon receiving approval from the European Agency for the Evaluation of Medicinal Products, or EMEA, to commence production of Renagel phosphate binder at the plant. We anticipate that the FDA will approve production of Renagel phosphate binder at the plant during 2003.
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During the three months ended June 30, 2003, worldwide sales of Renagel phosphate binder, including sales of bulk sevelamer, the raw material used to formulate Renagel phosphate binder, increased 67% as compared to the same period of 2002, primarily due to:
During the three months ended June 30, 2003, U.S. sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 58% to $46.0 million as compared to the same period of 2002, primarily due to:
Sales of Renagel phosphate binder, including sales of bulk sevelamer are 17% of our total product revenue for the three months ended June 30, 2003, as compared to 13% for the same period of 2002.
During the six months ended June 30, 2003, worldwide sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 81% as compared to the same period of 2002, primarily due to:
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During the six months ended June 30, 2003, U.S. sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 75% to $87.7 million as compared to the same period in 2002, primarily due to:
Sales of Renagel phosphate binder, including sales of bulk sevelamer are approximately 17% of our total product revenue for the six months ended June 30, 2003 as compared to 12% for the same period of 2002.
Genzyme GeneralDiagnostic Products
Diagnostic Products product revenue increased 10% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to:
Diagnostic Products product revenue increased 13% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to:
Other Product Revenue
Other product revenue increased 30% to $12.8 million for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to a 34% increase in the combined sales of liquid crystals, lipids, peptides and amino acid derivatives to $9.2 million and a 25% increase in the sales of hyaluronan-based products to $3.6 million.
Other product revenue increased 17% to $22.7 million for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to a 20% increase in the combined sales of liquid crystals, lipids, peptides and amino acid derivatives to $16.2 million and a 12% increase in the sales of hyaluronan-based products to $6.4 million.
Genzyme BiosurgeryProduct Revenue
In January 2003, as a result of a change in how Genzyme Biosurgery reviews its business, Genzyme Biosurgery reallocated:
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heart disease and congestive heart failure. Cardiac Devices products include fluid management (chest drainage) systems, surgical closures, biomaterials, and instruments for conventional and minimally invasive cardiac surgery;
Genzyme Biosurgery has reclassified its 2002 disclosures to conform to its 2003 presentation.
Genzyme BiosurgeryOrthopaedics
Orthopaedics product revenue increased 15% to $29.6 million for the three months and 22% to $56.0 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to increased sales of Synvisc viscosupplementation product. Synvisc viscosupplementation product sales increased in each period primarily due to increased utilization of the product within the existing customer base as well as the creation of new accounts. We believe that a significant competitor is currently seeking FDA approval for a viscosupplementation product that could have an adverse affect on future sales of Synvisc viscosupplementation product.
Genzyme BiosurgeryBiosurgical Specialties
Biosurgical Specialties product revenue increased 7% to $12.5 million for the three months and 13% to $24.6 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to 22% increases in the sales of Sepra products to $11.4 million for the three months and $21.8 million for the six months ended June 30, 2003, primarily due to increased market penetration.
Genzyme BiosurgeryCardiac Devices
Cardiac Devices product revenue remained stable for the three and six months ended June 30, 2003 as compared to the same periods of 2002.
Service Revenue
We derive service revenues from four principal sources:
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The following table sets forth our service revenues on a segment basis:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
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|
2003 |
2002 |
2003 |
2002 |
|||||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||||
Genzyme GeneralOther | $ | 25,321 | $ | 22,420 | 13 | % | $ | 49,776 | $ | 43,595 | 14 | % | |||||||
Genzyme Biosurgery: |
|||||||||||||||||||
Orthopaedic | 5,531 | 4,728 | 17 | % | 11,598 | 8,905 | 30 | % | |||||||||||
Biosurgical Specialties | 649 | 876 | (26 | )% | 1,622 | 1,907 | (15 | )% | |||||||||||
Cardiac Science | 11 | | N/A | 14 | | N/A | |||||||||||||
Cardiac Devices | 1 | | N/A | 1 | | N/A | |||||||||||||
Total service revenueGenzyme Biosurgery | 6,192 | 5,604 | 10 | % | 13,235 | 10,812 | 22 | % | |||||||||||
Genzyme Molecular Oncology |
37 |
|
N/A |
37 |
300 |
(88 |
)% |
||||||||||||
Total service revenue | $ | 31,550 | $ | 28,024 | 13 | % | $ | 63,048 | $ | 54,707 | 15 | % | |||||||
Genzyme General
Service revenue allocated to Genzyme General increased 13% for the three months and 14% for the six months ended June 30, 2003, as compared to the same periods of 2002. These increases are primarily attributable to:
Genzyme Biosurgery
Genzyme Biosurgery's Orthopaedics service revenue increased 17% to $5.5 million for the three months and 30% to $11.6 million for the six months ended June 30, 2003, as compared to the same periods a year ago, primarily due to the reclassification of $1.6 million for the three months and $3.2 million for the six months ended June 30, 2003 of reimbursed expenses from partners as service revenue.
Genzyme Biosurgery's Biosurgical Specialties service revenue decreased 26% to $0.6 million for the three months and 15% to $1.6 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to decreased sales of Epicel skin grafts, which are used to treat victims of severe burns. Sales of Epicel skin grafts are variable based upon a number of unpredictable factors, including the number of severe burn patients and their survival rate prior to treatment with Epicel skin grafts.
Genzyme Molecular Oncology
Genzyme Molecular Oncology's service revenue consists of revenues from the provision of services related to the SAGE genomics technology. Genzyme Molecular Oncology provides these services sporadically as customers request them. The focus of its SAGE business remains directed to granting licenses to the technology.
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International Product and Service Revenue
A substantial portion of our revenue was generated outside of the United States. Most of these revenues were attributable to sales of Cerezyme enzyme. The following table provides information regarding the change in international product and service sales as a percentage of total product and service revenue during the periods presented:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
|||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
|||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||
International product and service revenue | $ | 182,681 | $ | 128,173 | 43 | % | $ | 343,061 | $ | 248,394 | 38 | % | |||||
% of total product and service revenue | 44 | % | 39 | % | 43 | % | 40 | % |
The increase in international product and service revenue for the three months ended June 30, 2003, is primarily due to increased international sales of Cerezyme enzyme, Renagel phosphate binder and Fabrazyme enzyme.
International sales of Cerezyme enzyme increased 34% to $108.4 million for the three months ended June 30, 2003, as compared to $81.1 million in the same period of 2002. This increase is primarily due to:
International sales of Renagel phosphate binder increased 91% to $20.1 million for the three months ended June 30, 2003, as compared to $10.5 million for the same period of 2002. This increase is primarily due to:
International sales of Fabrazyme enzyme increased 150% to $15.0 million for the three months ended June 30, 2003, as compared to $6.0 million for the same period of 2002. This increase is primarily due to:
International product and service revenue as a percentage of total product and service revenue increased for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to the overall increase in international product and service sales and a $18.6 million positive impact on sales resulting from a 24% increase in the average exchange rate for the Euro.
The increase in international product and service revenue for the six months ended June 30, 2003, is primarily due to increased international sales of Cerezyme enzyme, Renagel phosphate binder and Fabrazyme enzyme.
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International sales of Cerezyme enzyme increased 28% to $203.2 million for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
International sales of Renagel phosphate binder increased 96% to $37.0 million for the six months ended June 30, 2003, as compared to $18.8 million in the same period of 2002, is primarily due to:
International sales of Fabrazyme enzyme increased 170% to $26.9 million for the six months ended June 30, 2003, as compared to $10.0 million in the same period of 2002 is primarily due to:
International product and service revenue as a percentage of total product and service revenue increased for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to the overall increase in international product and service sales and a $33.7 million positive impact on sales resulting from a 23% increase in the average exchange rate for the Euro.
Research and Development Revenue
We derive research and development revenue primarily from:
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The following table sets forth our research and development revenue on a segment basis:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
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|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
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|
2003 |
2002 |
2003 |
2002 |
|||||||||||||||
|
(Amounts in thousands, except percentage data) |
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Genzyme General: | |||||||||||||||||||
Therapeutics | $ | 1 | $ | 1,133 | (100 | )% | $ | 1 | $ | 2,929 | (100 | )% | |||||||
Other | 55 | | N/A | 98 | 31 | 216 | % | ||||||||||||
Eliminations/Adjustments | 733 | 859 | (15 | )% | 1,241 | 1,541 | (19 | )% | |||||||||||
Total research and development revenueGenzyme General | 789 | 1,992 | (60 | )% | 1,340 | 4,501 | (70 | )% | |||||||||||
Genzyme Biosurgery: |
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Orthopaedics | 116 | | N/A | 546 | | N/A | |||||||||||||
Biosurgical Specialties | 687 | 35 | 1,863 | % | 1,373 | 35 | 3,823 | % | |||||||||||
Cardiac Science | 84 | | N/A | 101 | | N/A | |||||||||||||
Total research and development revenueGenzyme Biosurgery | 887 | 35 | 2,434 | % | 2,020 | 35 | 5,671 | % | |||||||||||
Genzyme Molecular Oncology |
2,445 |
2,161 |
13 |
% |
4,633 |
4,283 |
8 |
% |
|||||||||||
Total research and development revenue | $ | 4,121 | $ | 4,188 | (2 | )% | $ | 7,993 | $ | 8,819 | (9 | )% | |||||||
Research and development revenue allocated to Genzyme General is related primarily to research and development activities performed under collaboration agreements. Eliminations/Adjustments includes research and development efforts Genzyme General conducted on behalf of GTC and amounts related to Genzyme General's research and development activities that we do not specifically allocate to a particular segment of Genzyme General.
Research and development revenue for Genzyme Biosurgery's Orthopaedics reporting segment is primarily due to reimbursements received from a partner for development projects associated with Synvisc viscosupplementation product beginning in 2003. Research and development revenue for Genzyme Biosurgery's Biosurgical Specialties reporting segment is primarily due to a milestone payment received for Hylaform® biomaterial product.
Research and development revenue allocated to Genzyme Molecular Oncology is derived from the following sources:
The slight increase in research and development revenue allocated to Genzyme Molecular Oncology for the three and six months ended June 30, 2003, as compared to the same period of 2002, is primarily due to a planned increase in the amount of research performed on behalf of both Purdue and Kirin Brewery Co., Ltd.
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The following table sets forth our product and service margins for each of our operating divisions:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Product margin: | ||||||||||||||||||
Genzyme General | $ | 246,358 | $ | 191,991 | 28 | % | $ | 465,821 | $ | 362,855 | 28 | % | ||||||
% of total product revenue | 64 | % | 64 | % | 64 | % | 64 | % | ||||||||||
Genzyme Biosurgery |
$ |
36,568 |
$ |
31,467 |
16 |
% |
$ |
68,760 |
$ |
55,075 |
25 |
% |
||||||
% of total product revenue | 10 | % | 10 | % | 9 | % | 10 | % | ||||||||||
Total product margin |
$ |
282,926 |
$ |
223,458 |
27 |
% |
$ |
534,581 |
$ |
417,930 |
28 |
% |
||||||
% of total product revenue | 74 | % | 74 | % | 73 | % | 74 | % | ||||||||||
Service margin: |
||||||||||||||||||
Genzyme General | $ | 8,842 | $ | 9,566 | (8 | )% | $ | 19,833 | $ | 18,875 | 5 | % | ||||||
% of total service revenue | 28 | % | 34 | % | 31 | % | 35 | % | ||||||||||
Genzyme Biosurgery |
$ |
3,417 |
$ |
2,019 |
69 |
% |
$ |
6,946 |
$ |
4,194 |
66 |
% |
||||||
% of total service revenue | 11 | % | 7 | % | 11 | % | 8 | % | ||||||||||
Genzyme Molecular Oncology |
$ |
20 |
$ |
|
N/A |
$ |
20 |
$ |
181 |
(89 |
)% |
|||||||
% of total service revenue | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||
Total service margin |
$ |
12,279 |
$ |
11,585 |
6 |
% |
$ |
26,799 |
$ |
23,250 |
15 |
% |
||||||
% of total service revenue | 39 | % | 41 | % | 43 | % | 42 | % | ||||||||||
Total product and service gross margin |
$ |
295,205 |
$ |
235,043 |
26 |
% |
$ |
561,380 |
$ |
441,180 |
27 |
% |
||||||
% of total product and service revenue | 71 | % | 72 | % | 71 | % | 71 | % |
Product Margin
Genzyme General
The 28% increase in Genzyme General's overall product margin for the three months ended June 30, 2003, as compared to same period of 2002, is primarily attributable to a 32% increase in product revenue. The increase in product margin is primarily attributable to an increase in sales of Therapeutics products, in addition to increased sales by our Renal and Diagnostic Products reporting segments for the three months ended June 30, 2003, as compared to same period of 2002.
Product margin for Genzyme General's Therapeutics reporting segment increased 26% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is due to a 27% increase in sales of Therapeutics products primarily attributable to increased sales of Cerezyme enzyme, Thyrogen hormone and Fabrazyme enzyme for the three months ended June 30, 2003, as compared to the same period of 2002.
Product margin for Genzyme General's Renal reporting segment increased 60% for the three months ended June 30, 2003 as compared to the same period of 2002. The increase is primarily due to a 67% increase in sales of Renagel phosphate binder for the three months ended June 30, 2003, as compared to the same period in 2002, offset by an increase in the rebate reserve for the product corresponding to an increase in our estimates of the percentage of patients being reimbursed by government programs. In addition, product margin for the Renal reporting segment is impacted by sales of bulk sevelamer, a lower margin product, to our Asian marketing partners.
Product margin for Genzyme General's Diagnostic Products reporting segment increased 18% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily due to a 10% increase in sales of Diagnostic Products for the three months ended June 30,
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2003, as compared to the same period of 2002, and only a 4% increase in the cost of products sold for the three months ended June 30, 2003, as compared to the same period of 2002.
The 28% increase in Genzyme General's overall product margin for the six months ended June 30, 2003, as compared to same period of 2002, is primarily attributable to a 32% increase in product revenue. The increase in product margin is primarily attributable to an increase in sales of Therapeutics products, in addition to increased sales of by our Renal and Diagnostic Products reporting segments for the six months ended June 30, 2003, as compared to same period of 2002.
Product margin for Genzyme General's Therapeutics reporting segment increased 23% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is due to a 26% increase in sales of Therapeutics products primarily attributable to increased sales of Cerezyme enzyme, Thyrogen hormone and Fabrazyme enzyme for the six months ended June 30, 2003, as compared to the same period of 2002. The increase in product margin for the six months ended June 30, 2003 is offset, in part, by the write off of $2.3 million of Cerezyme enzyme finished goods due to production issues, for which there is no similar write off in the same period of 2002.
Product margin for Genzyme General's Renal reporting segment increased 75% for the six months ended June 30, 2003 as compared to the same period of 2002. The increase is primarily due to a 81% increase in sales of Renagel phosphate binder for the six months ended June 30, 2003, as compared to the same period in 2002, offset by an increase in the rebate reserve for the product corresponding to an increase in our estimates of the percentage of patients being reimbursed by government programs. In addition, product margin for the Renal reporting segment is impacted by sales of bulk sevelamer, a lower margin product, to our Asian marketing partners.
Product margin for Genzyme General's Diagnostic Products reporting segment increased 50% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily due to a 13% increase in sales of Diagnostic Products for the six months ended June 30, 2003, as compared to the same period of 2002, and a 5% decrease in the cost of products sold for the six months ended June 30, 2003, as compared to the same period of 2002. The decrease in the cost of products sold is partially attributable to a charge of $2.9 million recorded in the six months ended June 30, 2002, for the closure of a Diagnostic Products manufacturing facility in San Carlos, California for which there is no comparable amount in the six months ended June 30, 2003.
Genzyme Biosurgery
Genzyme Biosurgery sells or provides a broad range of healthcare products and services. As a result, Genzyme Biosurgery's gross margins may vary significantly depending on the market conditions of each product or service.
The increases in Genzyme Biosurgery's product margin and in product margin as a percentage of product revenue for the three and six months ended June 30, 2003, as compared to the same periods of 2002, are primarily attributable to an increase in product revenue of $4.5 million for the three months and $13.7 million for the six months ended June 30, 2003.
Service Margin
Genzyme General
The 8% decrease in Genzyme General's service margin for the three months ended June 30, 2003, as compared to the same period of 2002, is primarily due to increased cost of services for our molecular genetics (DNA) and cancer testing services. Service margin as a percentage of service revenue decreased for the three months ended June 30, 2003, as compared to the same period of 2002. This was primarily attributable to a 13% increase in service revenue for the three months ended June 30, 2003 offset by an increase of 28% in the cost of services sold for the same period.
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The 5% increase in Genzyme General's service margin for the six months ended June 30, 2003, as compared to the same period of 2002, is primarily due to increased cost of services for our molecular genetics (DNA) and cancer testing services. Service margin as a percentage of service revenue decreased slightly for the six months ended June 30, 2003, as compared to the same period of 2002. The decrease is primarily attributable to a 14% increase in service revenue for the six months ended June 30, 2003 offset by an increase of 21% in the cost of services sold for the same period.
Genzyme Biosurgery
Service margin for services allocated to Genzyme Biosurgery increased 69% for the three months and 66% for the six months ended June 30, 2003, as compared to the same periods of 2002, and service margin as a percentage of service revenue increased during these periods primarily due to a 17% increase in sales of Orthopaedics services for the three months ended June 30, 2003 and a 30% increase in sales of Orthopaedics services for the six months ended June 30, 2003 as compared to the same periods in 2002. These increases were a result of the classification of $1.6 million for the three months ended June 30, 2003 and $3.2 million for the six months ended June 30, 2003 of reimbursed expenses from partners as service revenue.
OPERATING EXPENSES
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $19.9 million, or 18%, to $130.8 million for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
Selling, general and administrative expenses increased $31.2 million, or 15%, to $245.0 million for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
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Research and Development Expenses
Research and development expenses increased $3.1 million, or 4%, to $79.1 million for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
These increases were partially offset by:
Research and development expenses decreased $3.4 million, or 2%, to $154.7 million for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
These decreases were offset by:
The $7.5 million decrease in spending for Therapeutics research and development programs resulted partially from $10.8 million of additional charges that were included in research and development
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expenses for the six months ended June 30, 2002, for which there were no comparable amounts during the same period of 2003. The $10.8 million consisted of:
Amortization of Intangibles
There was no significant change in amortization of intangibles expense for the three and six months ended June 30, 2003, as compared to the same periods of 2002.
Charge for Impairment of Goodwill
In connection with our assessment of the value of Genzyme Biosurgery and the elimination of our tracking stock structure, we determined that the fair value of Genzyme Biosurgery's net assets was lower than their carrying value, indicating a potential impairment of the goodwill allocated to Genzyme Biosurgery's orthopaedics reporting unit, which resulted from our acquisition of Biomatrix in December 2000. Based on the analysis performed to date, we have concluded that the goodwill assigned to Genzyme Biosurgery's orthopaedics reporting unit is fully impaired. Accordingly, we recorded an estimated charge for impairment of goodwill of $102.8 million in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery in June 2003 to write off the goodwill allocated to Genzyme Biosurgery's orthopaedics reporting unit.
Charge for Impaired Asset
In connection with the sale of assets to Teleflex, we tested the carrying value of our manufacturing facility in Fall River, Massachusetts in June 2003 to determine whether the impairment recognition criteria in SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," had been met. In evaluating the facility for impairment, we considered the risks associated with the eventual sale of this facility, including the probability of finding a buyer for the facility, the amount of time that would likely be required to market and complete the sale of the facility and the estimated range of net proceeds that we could expect to receive. Our impairment analysis indicated that the carrying value for the Fall River facility would not be fully recoverable. As a result of this assessment, we recorded a charge for impaired asset of $2.9 million in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery in June 2003 to write down the carrying value of the Fall River facility to its estimated fair value.
Purchase of In-Process Research and Development
Novazyme
In September 2001, in connection with our acquisition of Novazyme, we acquired a technology platform that we believe can be leveraged in the development of treatments for various LSDs. As of the acquisition date, the technology platform had not achieved technological feasibility and would require significant further development to complete. Accordingly, we allocated to IPR&D and charged to expense $86.8 million, representing the portion of the purchase price attributable to the technology platform. We recorded this amount as a charge to expense in our consolidated statements of operations and the combined statements of operations of Genzyme General for the year ended December 31, 2001.
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The platform technology is specific to LSDs and there is currently no alternative use for the technology in the event that it fails as a platform for enzyme replacement therapy for the treatment of LSDs. As of June 30, 2003, we estimate that it will take approximately six to eight years and an investment of approximately $100 million to $125 million to complete the development of, obtain approval for and commercialize the first product based on this technology platform.
GelTex Pharmaceuticals, Inc.
In December 2000, in connection with the acquisition of GelTex, we allocated approximately $118.0 million of the purchase price to IPR&D, which we recorded as a charge to expense in our consolidated statements of operations and the combined statements of operations of Genzyme General for the year ended December 31, 2000. As of June 30, 2003, the technological feasibility of the projects had not yet been reached and no significant departures from the assumptions included in the valuation analysis had occurred.
Below is a brief description of the GelTex IPR&D projects, including an estimation of when management believes Genzyme General may realize revenues from the sales of these products for their respective indications:
Program |
Program Description or Indication |
|
Development Status at June 30, 2003 |
Value at Acquisition Date |
Estimated Cost to Complete at June 30, 2003 |
Year of Expected Product Launch |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
(in millions) |
|
|||||||||
Renagel phosphate binder |
Next stage non-absorbed polymer phosphate binder for the treatment of hyperphospatemia | | Clinical studies scheduled for completion in 2004 and 2005 | $ | 19.7 | $ | 9.3 | 2005 | ||||||
Tolevamer toxin binder |
C. difficile associated diarrhea |
|
Phase 2 trial expected to be completed in 2003 |
37.4 |
46.3 |
2007 |
||||||||
GT56-252 oral iron chelator |
Iron overload disease |
|
Phase 1/2 trial ongoing |
15.7 |
34.0 |
2007 |
||||||||
GT316-235 fat absorption inhibitor |
Anti-obesity |
|
Expected to file an IND in 2004 |
17.8 |
58.3 |
2010 |
||||||||
Polymer |
Oral mucositis |
|
Program cancelled during 2003; no further development planned |
17.8 |
N/A |
N/A |
||||||||
DENSPM |
Psoriasis |
|
Program cancelled during 2001; no further development planned |
3.4 |
N/A |
N/A |
||||||||
GT102-279 |
Second generation lipid-lowering compound |
|
Program cancelled during 2001; no further development planned |
6.2 |
N/A |
N/A |
||||||||
$ | 118.0 | $ | 147.9 | |||||||||||
Substantial additional research and development will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give you assurances that these programs will ever reach feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D
71
programs and technology platforms do not become commercially viable, our results of operations could be materially affected.
Biomatrix
In connection with our acquisition of Biomatrix, we allocated approximately $82.1 million to IPR&D, which Genzyme Biosurgery recorded as a charge to expense in its combined statement of operations for the year ended December 31, 2000. As of June 30, 2003, the technological feasibility of the Biomatrix IPR&D projects had not yet been reached and no significant departures from the assumptions included in the valuation analysis had occurred.
Below is a brief description of the Biomatrix IPR&D projects, including an estimation of when management believes we may realize revenues from the sales of these products in the respective application:
Program |
Program Description or Indication |
|
Development Status at June 30, 2003 |
Value at Acquisition Date |
Estimated Cost to Complete at June 30, 2003 |
Year of Expected Product Launch |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
(in millions) |
|
|||||||||
Viscosupplementation | Use of elastoviscous solutions and viscoelastic gels in disease conditions to supplement tissues and body fluids, alleviating pain and restoring normal function. | |
Received conditional FDA approval for hip indication clinical trial in United States Preclinical activities in the United States and clinical trial in Europe for knee indications Preclinical for other joints Product launched for hip indication in Europe in September 2002 |
$ | 33.8 | $ | 28.6 | 2002 to 2008 | ||||||
Visco-augmentation and Visco-separation (Adhesion prevention) |
Use of viscoelastic gels to provide scaffolding for tissue regeneration and to separate tissues and decrease formation of adhesions and excessive scars after surgery. |
|
Preclinicalgynecological and pelvic indications Clinical trialspivotal safety and efficacy study ongoing in United States for Hylaform biomaterials Phase 2spine indications; program cancelled during 2002; no further development planned |
48.3 N/A |
1.5 N/A |
2003 to 2004 N/A |
||||||||
$ |
82.1 |
$ |
30.1 |
|||||||||||
Except for our viscosupplementation product for the hip launched in Europe in 2002, substantial additional research and development will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give assurances that these programs will ever reach feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially affected.
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|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Equity in net loss of unconsolidated affiliates | $ | (4,804 | ) | $ | (3,948 | ) | 22 | % | $ | (8,998 | ) | $ | (8,042 | ) | 12 | % | ||
Gain (loss) on investments in equity securities | (3,620 | ) | 343 | (1,155 | )% | (3,620 | ) | 509 | (811 | )% | ||||||||
Loss on sale of product line | (29,367 | ) | | N/A | (29,367 | ) | | N/A | ||||||||||
Other | 769 | 1,827 | (58 | )% | 1,519 | 963 | 58 | % | ||||||||||
Investment income | 12,428 | 12,624 | (2 | )% | 24,042 | 26,061 | (8 | )% | ||||||||||
Interest expense | (6,335 | ) | (7,059 | ) | (10 | )% | (12,825 | ) | (13,865 | ) | (8 | )% | ||||||
Total other income (expenses) | $ | (30,929 | ) | $ | 3,787 | (917 | )% | $ | (29,249 | ) | $ | 5,626 | (620 | )% | ||||
Equity in Net Loss of Unconsolidated Affiliates
We record the results of the following joint ventures in equity in net loss of unconsolidated affiliates:
Joint Venture |
Partner |
Effective Date |
Product/Indication |
|||
---|---|---|---|---|---|---|
BioMarin/Genzyme LLC | BioMarin Pharmaceutical Inc. | September 1998 | Aldurazyme enzyme for the treatment of MPS I | |||
Diacrin/Genzyme LLC(1) |
Diacrin, Inc. |
October 1996 |
Products using porcine fetal cells for the treatment of Parkinson's and Huntington's diseases |
The following table presents our equity in net loss of unconsolidated affiliates by entity for the periods presented:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Joint Venture/Unconsolidated Affiliate |
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
2003 |
2002 |
2003 |
2002 |
|||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
BioMarin/Genzyme LLC | $ | (4,485 | ) | $ | (2,767 | ) | 62 | % | $ | (8,536 | ) | $ | (5,609 | ) | 52 | % | ||
Diacrin/Genzyme LLC | (46 | ) | (170 | ) | (73 | )% | (189 | ) | (320 | ) | (41 | )% | ||||||
Peptimmune | (273 | ) | | N/A | (273 | ) | | N/A | ||||||||||
GTC | | (1,011 | ) | (100 | )% | | (2,113 | ) | (100 | )% | ||||||||
Total | $ | (4,804 | ) | $ | (3,948 | ) | 22 | % | $ | (8,998 | ) | $ | (8,042 | ) | 12 | % | ||
We record in equity in net loss of unconsolidated affiliates our portion of the results of our joint ventures with BioMarin, Diacrin, our portion of the losses of Peptimmune and, through May 2002, our portion of the losses of GTC.
Our equity in net loss of unconsolidated affiliates increased 22% to $4.8 million for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is attributable to:
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Our equity in net loss of unconsolidated affiliates increased 12% to $9.0 million for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is attributable to:
On April 30, 2003, the FDA granted marketing approval for Aldurazyme enzyme as an enzyme replacement therapy for patients with the Hurler and Hurler-Scheie forms of MPS I, and Scheie patients with moderate to severe symptoms. Aldurazyme enzyme has been granted orphan drug status in the United States, which provides seven years of market exclusivity. On June 11, 2003, the European Commission granted marketing approval for Aldurazyme enzyme to treat the non-neurological manifestations of MPS I in patients with a confirmed diagnosis of the disease. Aldurazyme enzyme has been granted orphan drug status in the European Union, which provides ten years of market exclusivity. We are commercializing Aldurazyme enzyme in the United States and will launch Aldurazyme enzyme in the European Union on a country-by-country basis as pricing and reimbursement approvals are obtained. Aldurazyme enzyme is manufactured at BioMarin's plant in California and will be sent to either our manufacturing facility in Allston, Massachusetts or to a third-party facility for the final filling and finish process.
On April 4, 2002, GTC purchased approximately 2.8 million shares of GTC common stock held by us and allocated to Genzyme General for an aggregate consideration of $9.6 million. We received $4.8 million in cash and a promissory note for the remaining amount. The shares of GTC common stock sold were valued at $3.385 per share in this transaction, using the simple average of the high and low transaction prices quoted on the Nasdaq National Market on April 1, 2002. We have committed to 24-month lock-up provision on the remaining 4.9 million shares of GTC common stock held by us and allocated to Genzyme General, which is approximately 17% of the shares of GTC common stock outstanding as of June 30, 2003. We accounted for our investment in GTC under the equity method of accounting until May 2002, at which point our ownership interest and board representation was reduced below 20% and we did not have any other factors of significant influence. Accordingly, we ceased to have significant influence over GTC and we began accounting for our investment in GTC under the cost method of accounting in June 2002. Equity in net loss of unconsolidated affiliates in our consolidated statements of operations and the combined statements of operations of Genzyme General includes charges of $1.0 million for the three months and $2.1 million for the six months ended June 30, 2002, representing our portion of the losses of GTC.
In January 2002, we formed Peptimmune as our wholly-owned subsidiary, by contributing $5.0 million of cash and $0.3 million of other assets to Peptimmune in exchange for 5.5 million shares of Peptimmune's Series A voting preferred stock and 100 shares of Peptimmune common stock. We allocated our investment in Peptimmune to Genzyme General. We consolidated the results of Peptimmune through February 2003 because during that period we owned 100% of its outstanding stock. In March 2003, our investment in Peptimmune decreased to approximately 12% as a result of the sale by Peptimmune of shares of its Series B voting preferred stock to third party investors. In accordance with our policy pertaining to affiliate sales of stock, we recorded a $2.9 million net gain ($4.5 million pre-tax) due to this sale, which was recorded as an increase to our investment in Peptimmune in other noncurrent assets and an increase to other comprehensive income in stockholders equity in our consolidated balance sheet. Although our ownership interest in Peptimmune has declined below 20%, we account for our investment in Peptimmune under the equity method of accounting because certain factors exist that cause us to continue to have significant influence over Peptimmune,
74
including that the chairman, president and chief executive officer of Peptimmune is a member of our board of directors, one of our corporate officers is a consultant to Peptimmune and we have service agreements with Peptimmune. Our equity in the net losses of Peptimmune have not been significant to date.
Gain on Investment in Equity Securities
At December 31, 2002, the remaining 4.9 million shares of GTC common stock that we held did not qualify as marketable securities under SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities" because we were within the first 12 months of the 24-month lock-up provision described above. As a result, we carried our investment in GTC on our consolidated balance sheets and the combined balance sheets of Genzyme General at cost, subject to review for impairment. Effective April 4, 2003, we began the last 12 months of the 24-month lock-up provision and, as a result, the remaining shares of GTC common stock that we hold now qualify as marketable securities under SFAS No. 115 and are carried on our consolidated balance sheets and the combined balance sheets of Genzyme General at fair value.
We review the carrying value of each of our strategic investments in equity securities on a quarterly basis for potential impairment. In June 2003, we recorded a $3.6 million impairment charge in connection with our investment in the common stock of ABIOMED because we considered the decline in value of this investment to be other than temporary. Given the significance and duration of the decline as of June 30, 2003, we concluded that it was unclear over what period the recovery of the stock price for this investment would take place, and, accordingly, that any evidence suggesting that the investment would recover to at least our historical cost was not sufficient to overcome the presumption that the current market price was the best indicator of the value of this investment.
At June 30, 2003, our stockholders equity includes $16.4 million of unrealized gains and $0.3 million of unrealized losses related to our other investments in equity securities, all of which are allocated to Genzyme General. We believe the losses related to our other investments in equity securities are temporary.
Other
We periodically enter foreign currency forward contracts, all of which have durations of less than three months. These contracts have not been designated as hedges and, accordingly, unrealized gains or losses on these contracts are reported in current earnings. The notional settlement value of foreign currency forward contracts outstanding as of June 30, 2003 is $52.0 million. At June 30, 2003 and 2002, the contracts fair value, representing an unrealized gain or loss, was not significant in each period presented.
For the three months ended June 30, 2003, we also recorded in other in our consolidated statements of operations and the combined statements of operations of Genzyme General an unrealized gain of $0.8 million to reflect the change in value of our warrants to purchase shares of GTC common stock from April 1, 2003 to June 30, 2003, as compared to an unrealized loss of $0.9 million for the same period of 2002.
For the six months ended June 30, 2003, we recorded an unrealized gain of $0.9 million to reflect the change in value of our warrants to purchase shares of GTC common stock from January 1, 2003 to June 30, 2003, as compared to an unrealized loss of $2.1 million for the same period of 2002.
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Investment Income
Our investment income decreased 2% for the three months and 8% for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to a decrease in interest rates, despite higher average cash balances.
Interest Expense
Our interest expense decreased 10% for the three months and 8% for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to a slight decline in debt balances outstanding resulting from the repayment, in 2002, of notes payable, aggregating $7.0 million, assumed in connection with our acquisitions of Novazyme in September 2001 and GelTex in December 2000 and the satisfaction of the $10.0 million, 6.9% convertible subordinated note in May 2003, assumed in connection with our acquisition of Biomatrix.
Tax Provision
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
|||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
|||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||
Provision for income taxes | $ | (9,726 | ) | $ | (10,293 | ) | (6 | )% | $ | (28,724 | ) | $ | (13,431 | ) | 114 | % | |
Effective tax rate | 15 | % | 27 | % | 6,573 | % | 28 | % |
Our tax rates for all periods presented vary from the U.S. statutory tax rate as a result of our:
The decrease in our tax rate for the three and six months ended June 30, 2003, as compared to the same period of 2002, is primarily due to increased benefits from orphan drug credits.
CUMULATIVE EFFECT OF CHANGE IN ACCOUNTING FOR GOODWILL
On January 1, 2002, we adopted SFAS No. 142, which requires that ratable amortization of goodwill and certain intangible assets be replaced with periodic tests of goodwill's impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. SFAS No. 142 requires a transitional impairment test to compare the fair value of a reporting unit with the carrying amount of the goodwill.
Upon adoption of SFAS No. 142, Genzyme Biosurgery tested the goodwill of the cardiothoracic reporting unit in accordance with the transitional provisions of that standard, using the present value of expected future cash flows to estimate the fair value of this reporting unit. Genzyme Biosurgery recorded an impairment charge of $98.3 million, which was reflected as a cumulative effect of a change in accounting for goodwill in our consolidated statements of operations and the combined statements of operations for Genzyme Biosurgery for the three months ended March 31, 2002.
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GENZYME GENERAL
A Division of Genzyme Corporation
The following discussion summarizes the key factors our management believes necessary for an understanding of Genzyme General's financial statements. When reviewing this discussion, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under "Factors Affecting Future Operating Results" below. These risks and uncertainties could cause our actual results to differ materially from those forecast in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward-looking statements under "Note Regarding Forward-Looking Statements." These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock, were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery and Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangements previously approved by our board of directors that had made a portion of Genzyme General's cash available to Genzyme Biosurgery and Genzyme Molecular Oncology.
Effective July 1, 2003, in connection with the elimination of our tracking stock structure, we will cease allocating earnings to Biosurgery Stock and Molecular Oncology Stock. From that date forward, all of our earnings will be allocated to Genzyme General Stock. Earnings allocated to Biosurgery Stock and Molecular Oncology Stock prior to July 1, 2003 will remain allocated to those stocks and will not be affected by the elimination of our tracking stock structure. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and management's discussion and analysis for each of our divisions but will continue to provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES
The critical accounting policies and significant estimates for Genzyme General are set forth under the heading "Management's Discussion and Analysis of Genzyme General's Financial Condition and Results of OperationsCritical Accounting Policies and Significant Estimates" in Exhibit 13.2 to our 2002 Form 10-K. There have been no changes to these policies and no significant changes to these estimates since December 31, 2002.
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REVENUES
The components of Genzyme General's total revenues are described in the following table:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Product revenue | $ | 321,553 | $ | 242,756 | 32 | % | $ | 610,592 | $ | 461,219 | 32 | % | ||||||
Service revenue | 25,321 | 22,420 | 13 | % | 49,776 | 43,595 | 14 | % | ||||||||||
Total product and service revenue | 346,874 | 265,176 | 31 | % | 660,368 | 504,814 | 31 | % | ||||||||||
Research and development revenue | 789 | 1,992 | (60 | )% | 1,340 | 4,501 | (70 | )% | ||||||||||
Total revenues | $ | 347,663 | $ | 267,168 | 30 | % | $ | 661,708 | $ | 509,315 | 30 | % | ||||||
Product and Service Revenue
The following table sets forth Genzyme General's product and service revenues on a segment basis:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||||
Product Revenue: | ||||||||||||||||||||
Therapeutics: | ||||||||||||||||||||
Cerezyme enzyme | $ | 184,724 | $ | 154,717 | 19 | % | $ | 351,911 | $ | 302,783 | 16 | % | ||||||||
Other therapeutic products | 35,433 | 18,083 | 96 | % | 65,457 | 29,528 | 122 | % | ||||||||||||
Total Therapeutics | 220,157 | 172,800 | 27 | % | 417,368 | 332,311 | 26 | % | ||||||||||||
Renal |
66,002 |
39,543 |
67 |
% |
124,768 |
69,075 |
81 |
% |
||||||||||||
Diagnostic Products | 22,554 | 20,530 | 10 | % | 45,750 | 40,368 | 13 | % | ||||||||||||
Other | 12,840 | 9,883 | 30 | % | 22,706 | 19,465 | 17 | % | ||||||||||||
Total product revenue | 321,553 | 242,756 | 32 | % | 610,592 | 461,219 | 2 | % | ||||||||||||
Service Revenue: | ||||||||||||||||||||
Other | 25,321 | 22,420 | 13 | % | 49,776 | 43,595 | 14 | % | ||||||||||||
Total product and service revenue | $ | 346,874 | $ | 265,176 | 31 | % | $ | 660,368 | $ | 504,814 | 31 | % | ||||||||
Therapeutics
Genzyme General's increase in Therapeutics product revenue for the three and six months ended June 30, 2003, as compared to the same periods of 2002, is primarily due to continued growth in sales of Cerezyme enzyme for the treatment of Type 1 Gaucher disease and increased sales of other therapeutic products. Other therapeutic products revenue consists primarily of:
The growth in sales of Cerezyme enzyme for the three and six months ended June 30, 2003, as compared to the same periods of 2002, is attributable to Genzyme General's continued identification of
78
new Gaucher disease patients worldwide, particularly in Europe, resulting from a significant investment in our global sales and marketing infrastructure. The growth in sales of Cerezyme enzyme in both periods was also positively impacted by the weakened U.S. Dollar. During the three months ended June 30, 2003, the U.S. Dollar weakened against the Euro on average by 24%, as compared to the same period of 2002, which positively impacted sales by $12.8 million. During the six months ended June 30, 2003, the U.S. Dollar weakened against the Euro on average by 23%, as compared to the same period of 2002, which positively impacted sales by $23.3 million. Sales of Cerezyme enzyme are approximately 57% of Genzyme General's total product revenue for the three months ended June 30, 2003, as compared to 64% for the same period of 2002. Sales of Cerezyme enzyme are approximately 58% of Genzyme General's total product revenue for the six months ended June 30, 2003, as compared to 66% for the same period of 2002.
Genzyme General's results of operations are highly dependent on sales of Cerezyme enzyme and a reduction in revenue from sales of this product would adversely affect its results of operations. Revenue from Cerezyme enzyme would be impacted negatively if competitors developed alternative treatments for Gaucher disease and the alternative products gained commercial acceptance. Although orphan drug status for Cerezyme enzyme, which provided us with exclusive marketing rights for Cerezyme enzyme in the United States, expired in May 2001, we continue to have patents protecting our method of manufacturing Cerezyme enzyme until 2010 and the composition of Cerezyme enzyme as made by that process until 2013. The expiration of market exclusivity and orphan drug status will likely subject Cerezyme enzyme to increased competition, which may decrease the amount of revenue we receive from this product or the growth of that revenue.
Genzyme General is aware of companies that have initiated efforts to develop competitive products, and other companies may do so in the future. For example, Celltech Group plc and Actelion Ltd are developing Zavesca, a small molecule drug candidate for the treatment of Type 1 Gaucher disease. Zavesca has been approved by both the FDA and the European Commission as an oral therapy for use in patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. Celltech/Actelion will be required to submit follow-up safety data on the product as a condition of these approvals. Zavesca has also been approved by the Israeli Ministry of Health. Teva Pharmaceuticals, a licensee of Celltech, has the rights to Zavesca in Israel. To date, virtually all Gaucher disease patients who have received enzyme therapy have experienced strong clinical benefit with few side effects so we do not expect the competition from Zavesca to have a significant impact on our sales of Cerezyme enzyme.
The increase in other therapeutic products revenue for the three months ended June 30, 2003, as compared to the same period of 2002, is attributable to:
79
On April 24, 2003, the FDA granted marketing approval for Fabrazyme enzyme for Fabry disease. Fabrazyme enzyme has received orphan drug status, which provides seven years of market exclusivity in the United States. We have agreed with the FDA on a number of post-marketing commitments, as a condition of this approval. If we fail to meet these commitments, our ability to continue marketing Fabrazyme enzyme in the United States may be adversely affected.
The increase in other therapeutic products revenue for the six months ended June 30, 2003, as compared to the same period of 2002, is attributable to:
Renal
In September 2002, we created the Renal reporting segment consisting primarily of amounts attributable to the manufacture and sale of Renagel phosphate binder. Previously, amounts attributable to the manufacture and sale of Renagel phosphate binder had been included as a component of Genzyme General's Therapeutics reporting segment. We have reclassified Genzyme General's 2002 disclosures to conform to its 2003 presentation. Genzyme General expects sales of Renagel phosphate binder to increase, driven primarily by the continued adoption of the product by nephrologists worldwide. Our ability to increase sales of Renagel phosphate binder will be dependent on several factors, including:
During the three months ended March 31, 2003, we obtained reimbursement approval for the 800 mg tablet formulation of Renagel phosphate binder in France, the last major European market where this form of the product had previously been unavailable. In addition, in March 2003, we began
80
shipping Renagel phosphate binder tablets to the European market from our new cGMP manufacturing facility in Waterford, Ireland, upon receiving approval from the EMEA to commence production of Renagel phosphate binder at the plant. We anticipate that the FDA will approve production of Renagel phosphate binder at the plant during 2003.
During the three months ended June 30, 2003, worldwide sales of Renagel phosphate binder, including sales of bulk sevelamer, the raw material used to formulate Renagel phosphate binder, increased 67% as compared to the same period of 2002, primarily due to:
During the three months ended June 30, 2003, U.S. sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 58% to $45.9 million as compared to the same period of 2002, primarily due to:
Sales of Renagel phosphate binder, including sales of bulk sevelamer are 21% of Genzyme General's total product revenue for the three months ended June 30, 2003, as compared to 16% for the same period of 2002.
During the six months ended June 30, 2003, worldwide sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 81% as compared to the same period of 2002, primarily due to:
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During the six months ended June 30, 2003, U.S. sales of Renagel phosphate binder, including sales of bulk sevelamer, increased 75% to $87.7 million as compared to the same period in 2002, primarily due to:
Sales of Renagel phosphate binder, including sales of bulk sevelamer are approximately 20% of Genzyme General's total product revenue for the six months ended June 30, 2003 as compared to 15% for the same period of 2002.
Diagnostic Products
Diagnostic Products product revenue increased 10% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to:
Diagnostic Products product revenue increased 13% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to:
Other Product and Service Revenue
Other product revenue increased 30% to $12.8 million for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to a 34% increase in the combined sales of liquid crystals, lipids, peptides and amino acid derivatives to $9.2 million and a 25% increase in the sales of hyaluronan-based products to $3.6 million.
Other product revenue increased 17% to $22.7 million for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily attributable to a 20% increase in the combined sales of liquid crystals, lipids, peptides and amino acid derivatives to $16.2 million and a 12% increase in the sales of hyaluronan-based products to $6.4 million.
Service revenue increased 13% for the three months and 14% for the six months ended June 30, 2003, as compared to the same periods of 2002. These increases are primarily attributable to:
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International Product and Service Revenue
A substantial portion of Genzyme General's revenue was generated outside of the United States. Most of these revenues were attributable to sales of Cerezyme enzyme. The following table provides information regarding the change in international product and service revenue as a percentage of total product and service revenue during the periods presented:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
|||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
|||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||
International product and service revenue | $ | 162,223 | $ | 111,393 | 46 | % | $ | 302,832 | $ | 214,907 | 41 | % | |||||
% of total product and service revenue | 47 | % | 42 | % | 46 | % | 43 | % |
The increase in international product and service revenue for the three months ended June 30, 2003, is primarily due to increased international sales of Cerezyme enzyme, Renagel phosphate binder and Fabrazyme enzyme.
International sales of Cerezyme enzyme increased 34% to $108.4 million for the three months ended June 30, 2003, as compared to $81.1 million in the same period of 2002, primarily due to:
International sales of Renagel phosphate binder increased 91% to $20.1 million for the three months ended June 30, 2003, as compared to $10.5 million for the same period of 2002, primarily due to:
International sales of Fabrazyme enzyme increased 150% to $15.0 million for the three months ended June 30, 2003, as compared to $6.0 million for the same period of 2002, primarily due to:
International product and service revenue as a percentage of total product and service revenue increased for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to the overall increase in international product and service sales and a $18.6 million positive impact on sales resulting from a 24% increase in the average exchange rate for the Euro.
The increase in international product and service revenue for the six months ended June 30, 2003, is primarily due to increased international sales of Cerezyme enzyme, Renagel phosphate binder and Fabrazyme enzyme.
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International sales of Cerezyme enzyme increased 28% to $203.2 million for the six months ended June 30, 2003, as compared to $158.9 million in the same period of 2002, primarily due to:
International sales of Renagel phosphate binder increased 96% to $37.0 million for the six months ended June 30, 2003, as compared to $18.8 million for the same period of 2002, primarily due to:
International sales of Fabrazyme enzyme increased 170% to $26.9 million for the three months ended June 30, 2003, as compared to $10.0 million for the same period of 2002, primarily due to:
International product and service revenue as a percentage of total product and service revenue increased for the six months ended June 30, 2003 as compared to the same period of 2002 primarily due to the overall increase in international product and service sales and a $33.7 million positive impact on sales resulting from a 23% increase in the average exchange rate of the Euro.
Research and Development Revenue
The following table sets forth our research and development revenue on a segment basis:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Therapeutics | $ | 1 | $ | 1,133 | (100 | )% | $ | 1 | $ | 2,929 | (100 | )% | ||||||
Other | 55 | | N/A | 98 | 31 | 216 | % | |||||||||||
Eliminations/Adjustments | 733 | 859 | (15 | )% | 1,241 | 1,541 | (19 | )% | ||||||||||
Total research and development revenues | $ | 789 | $ | 1,992 | (60 | )% | $ | 1,340 | $ | 4,501 | (70 | )% | ||||||
Research and development revenue allocated to Genzyme General is related primarily to research and development activities performed under collaboration agreements. Eliminations/Adjustments includes research and development efforts Genzyme General conducted on behalf of GTC and amounts related to Genzyme General's research and development activities that we do not specifically allocate to a particular segment of Genzyme General.
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MARGINS
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Product margin | $ | 246,358 | $ | 191,991 | 28 | % | $ | 465,821 | $ | 362,855 | 28 | % | ||||||
% of product revenue | 77 | % | 79 | % | 76 | % | 79 | % | ||||||||||
Service margin |
8,842 |
9,566 |
(8 |
)% |
19,833 |
18,875 |
5 |
% |
||||||||||
% of service revenue | 35 | % | 43 | % | 40 | % | 43 | % | ||||||||||
Total product and service gross margin |
$ |
255,200 |
$ |
201,557 |
27 |
% |
$ |
485,654 |
$ |
381,730 |
27 |
% |
||||||
% of total product and service revenue | 74 | % | 76 | % | 74 | % | 76 | % |
Genzyme General provides a broad range of healthcare products and services. As a result, Genzyme General's gross margin may vary significantly based on the category of product or service. Sales of therapeutic products, including Cerezyme enzyme, result in higher margins than diagnostic products.
Product Margin
The 28% increase in Genzyme General's overall product margin for the three months ended June 30, 2003, as compared to same period of 2002, is primarily attributable to a 32% increase in product revenue. The increase in product margin is primarily attributable to an increase in sales of Therapeutics products, in addition to increased sales of products by our Renal and Diagnostic Products reporting segments for the three months ended June 30, 2003, as compared to same period of 2002.
Product margin for the Therapeutics reporting segment increased 26% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is due to a 27% increase in sales of Therapeutics products primarily attributable to increased sales of Cerezyme enzyme, Thyrogen hormone and Fabrazyme enzyme for the three months ended June 30, 2003, as compared to the same period of 2002.
Product margin for the Renal reporting segment increased 60% for the three months ended June 30, 2003 as compared to the same period of 2002. The increase is primarily due to a 67% increase in sales of Renagel phosphate binder for the three months ended June 30, 2003, as compared to the same period in 2002, offset by an increase in the rebate reserve for the product corresponding to an increase in our estimates of the percentage of patients being reimbursed by government programs. In addition, product margin for the Renal reporting segment is impacted by sales of bulk sevelamer, a lower margin product, to our Asian marketing partners.
Product margin for the Diagnostic Products reporting segment increased 18% for the three months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily due to a 10% increase in sales of Diagnostic Products for the three months ended June 30, 2003, as compared to the same period of 2002, and only a 4% increase in the cost of products sold for the three months ended June 30, 2003, as compared to the same period of 2002.
The 28% increase in Genzyme General's overall product margin for the six months ended June 30, 2003, as compared to same period of 2002, was primarily attributable to a 32% increase in product revenue. The increase in product margin is primarily attributable to an increase in sales of Therapeutics products, in addition to increased sales of Renal and Diagnostic Products for the six months ended June 30, 2003, as compared to same period of 2002.
Product margin for the Therapeutics reporting segment increased 23% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is due to a 26% increase in sales of Therapeutics products primarily attributable to increased sales of Cerezyme enzyme, Thyrogen
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hormone and Fabrazyme enzyme for the six months ended June 30, 2003, as compared to the same period of 2002. The increase in product margin for the six months ended June 30, 2003 was offset, in part, by the write off of $2.3 million of Cerezyme enzyme finished goods due to production issues, for which there is no similar write off in the same period of 2002.
Product margin for the Renal reporting segment increased 75% for the six months ended June 30, 2003 as compared to the same period of 2002. The increase is primarily due to a 81% increase in sales of Renagel phosphate binder for the six months ended June 30, 2003, as compared to the same period in 2002, offset by an increase in the rebate reserve for the product corresponding to an increase in our estimates of the percentage of patients being reimbursed by government programs. In addition, product margin for the Renal reporting segment is impacted by sales of bulk sevelamer, a lower margin product, to our Asian marketing partners.
Product margin for the Diagnostic Products reporting segment increased 50% for the six months ended June 30, 2003, as compared to the same period of 2002. The increase is primarily due to a 13% increase in sales of Diagnostic Products for the six months ended June 30, 2003, as compared to the same period of 2002, and a 5% decrease in the cost of products sold for the six months ended June 30, 2003, as compared to the same period of 2002. The decrease in the cost of products sold is partially attributable to a charge of $2.9 million recorded in the six months ended June 30, 2002, for the closure of a Diagnostic Products manufacturing facility in San Carlos, California for which there is no comparable amount in the six months ended June 30, 2003.
Service Margin
The 8% decrease in service margin for the three months ended June 30, 2003, as compared to the same period of 2002 is primarily due to increased cost of services for our molecular genetics (DNA) and cancer testing services offset by increased cost of services sold attributable primarily to our molecular genetics (DNA) services. Service margin as a percentage of service revenue decreased for the three months ended June 30, 2003, as compared to the same period of 2002. This is primarily attributable to a 13% increase in service revenue for the three months ended June 30, 2003 offset by an increase of 28% in the cost of services sold for the same period.
The 5% increase in service margin for the six months ended June 30, 2003, as compared to the same period of 2002 is primarily due to increased cost of services for our molecular genetics (DNA) and cancer testing services. Service margin as a percentage of service revenue decreased slightly for the six months ended June 30, 2003, as compared to the same period of 2002. This is primarily attributable to a 14% increase in service revenue for the six months ended June 30, 2003 offset by an increase of 21% in the cost of services sold for the same period.
OPERATING EXPENSES
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $14.7 million, or 18%, to $95.2 million for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
86
Selling, general and administrative expenses increased $23.5 million, or 15%, to $180.4 million for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
Research and Development Expenses
Research and development expenses increased $2.4 million, or 4%, to $58.8 million for the three months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
Research and development expenses decreased $5.2 million, or 4%, to $115.2 million for the six months ended June 30, 2003, as compared to the same period of 2002, primarily due to:
The $7.5 million decrease in spending for Therapeutics research and development programs resulted partially from $10.8 million of additional charges that were included in research and development expenses for the first quarter of 2002, for which there were no comparable amounts during the same period of 2003. The $10.8 million consisted of:
Amortization of Intangibles
There was no significant change in amortization of intangibles expense for the three and six months ended June 30, 2003, as compared to the same periods of 2002.
87
Purchase of In-Process Research and Development
Novazyme
In September 2001, in connection with our acquisition of Novazyme, we acquired a technology platform that we believe can be leveraged in the development of treatments for various LSDs. As of the acquisition date, the technology platform had not achieved technological feasibility and would require significant further development to complete. Accordingly, we allocated to IPR&D and charged to expense $86.8 million, representing the portion of the purchase price attributable to the technology platform. We recorded this amount as a charge to expense in our consolidated statements of operations and the combined statements of operations of Genzyme General for the year ended December 31, 2001.
The platform technology is specific to LSDs and there is currently no alternative use for the technology in the event that it fails as a platform for enzyme replacement therapy for the treatment of LSDs. As of June 30, 2003, we estimate that it will take approximately six to eight years and an investment of approximately $100 million to $125 million to complete the development of, obtain approval for and commercialize the first product based on this technology platform.
GelTex
In December 2000, in connection with the acquisition of GelTex, we allocated approximately $118.0 million of the purchase price to IPR&D, which we recorded as a charge to expense in our consolidated statements of operations and the combined statements of operations of Genzyme General for the year ended December 31, 2000. As of June 30, 2003, the technological feasibility of the projects had not yet been reached and no significant departures from the assumptions included in the valuation analysis had occurred.
Below is a brief description of the GelTex IPR&D projects, including an estimation of when management believes Genzyme General may realize revenues from the sales of these products for their respective indications:
Program |
Program Description or Indication |
|
Development Status at June 30, 2003 |
Value at Acquisition Date |
Estimated Cost to Complete at June 30, 2003 |
Year of Expected Product Launch |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
(in millions) |
|
|||||||||
Renagel phosphate binder | Next stage non-absorbed polymer phosphate binder for the treatment of hyperphospatemia | | Clinical studies scheduled for completion in 2004 and 2005 | $ | 19.7 | $ | 9.3 | 2005 | ||||||
Tolevamer toxin binder |
C. difficile associated diarrhea |
|
Phase 2 trial expected to be completed in 2003 |
37.4 |
46.3 |
2007 |
||||||||
GT56-252 oral iron chelator |
Iron overload disease |
|
Phase 1/2 trial ongoing |
15.7 |
34.0 |
2007 |
||||||||
GT316-235 fat absorption inhibitor |
Anti-obesity |
|
Expected to file an IND in 2004 |
17.8 |
58.3 |
2010 |
||||||||
Polymer |
Oral mucositis |
|
Program cancelled during 2003; no further development planned |
17.8 |
N/A |
N/A |
||||||||
DENSPM |
Psoriasis |
|
Program cancelled during 2001; no further development planned |
3.4 |
N/A |
N/A |
||||||||
GT102-279 |
Second generation lipid-lowering compound |
|
Program cancelled during 2001; no further development planned |
6.2 |
N/A |
N/A |
||||||||
$ | 118.0 | $ | 147.9 | |||||||||||
88
Substantial additional research and development will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give you assurances that these programs will ever reach feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially affected.
OTHER INCOME AND EXPENSES
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Equity in net loss of unconsolidated affiliates | $ | (4,804 | ) | $ | (3,948 | ) | 22 | % | $ | (8,998 | ) | $ | (8,042 | ) | 12 | % | ||
Gain (loss) on investments in equity securities | (3,620 | ) | 343 | (1,155 | )% | (3,620 | ) | 509 | (811 | )% | ||||||||
Other | 774 | 1,749 | (56 | )% | 1,554 | 852 | 82 | % | ||||||||||
Investment income | 12,058 | 12,079 | | 23,339 | 25,031 | (7 | )% | |||||||||||
Interest expense | (4,328 | ) | (4,678 | ) | (7 | )% | (8,605 | ) | (9,219 | ) | (7 | )% | ||||||
Total other income (expenses) | $ | 80 | $ | 5,545 | (99 | )% | $ | 3,670 | $ | 9,131 | (60 | )% | ||||||
Equity in Net Loss of Unconsolidated Affiliates
The following table presents our equity in net loss of unconsolidated affiliate by entity for the periods presented:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Joint Venture/Unconsolidated Affiliate |
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
2003 |
2002 |
2003 |
2002 |
|||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
BioMarin/Genzyme LLC | $ | (4,485 | ) | $ | (2,767 | ) | 62 | % | $ | (8,536 | ) | $ | (5,609 | ) | 52 | % | ||
Diacrin/Genzyme LLC | (46 | ) | (170 | ) | (73 | )% | (189 | ) | (320 | ) | (41 | )% | ||||||
Peptimmune | (273 | ) | | N/A | (273 | ) | | N/A | ||||||||||
GTC | | (1,011 | ) | (100 | )% | | (2,113 | ) | (100 | )% | ||||||||
Total | $ | (4,804 | ) | $ | (3,948 | ) | 22 | % | $ | (8,998 | ) | $ | (8,042 | ) | 12 | % | ||
Genzyme General records in equity in net loss of unconsolidated affiliates its portion of the results of our joint ventures with BioMarin, Diacrin, our portion of losses of Peptimmune and, through May 2002, our portion of the losses of GTC.
Genzyme General's equity in net loss of unconsolidated affiliates increased 22% to $4.8 million for the three months ended June 30, 2003, as compared to the same period of 2002. The increase was attributable to:
89
Genzyme General's equity in net loss of unconsolidated affiliates increased 12% to $9.0 million for the six months ended June 30, 2003, as compared to the same period of 2002. The increase was attributable to:
On April 30, 2003, the FDA granted marketing approval for Aldurazyme enzyme as an enzyme replacement therapy for patients with the Hurler and Hurler-Scheie forms of MPS I, and for Scheie patients with moderate to severe symptoms. Aldurazyme enzyme has been granted orphan drug status in the United States, which provides seven years of market exclusivity. On June 11, 2003, the European Commission granted marketing approval for Aldurazyme enzyme to treat the non-neurological manifestations of MPS I in patients with a confirmed diagnosis of the disease. Aldurazyme enzyme has been granted orphan drug status in the European Union, which provides ten years of market exclusivity. We are commercializing Aldurazyme enzyme in the United States and will launch Aldurazyme enzyme in the European Union on a country-by-country basis as pricing and reimbursement approvals are obtained. Aldurazyme enzyme is manufactured at BioMarin's plant in California and will be sent to either our manufacturing facility in Allston, Massachusetts or to a third-party facility for the final filling and finish process.
On April 4, 2002, GTC purchased approximately 2.8 million shares of GTC common stock held by us and allocated to Genzyme General for an aggregate consideration of $9.6 million. We received $4.8 million in cash and a promissory note for the remaining amount. The shares of GTC common stock sold were valued at $3.385 per share in this transaction, using the simple average of the high and low transaction prices quoted on the Nasdaq National Market on April 1, 2002. We have committed to 24-month lock-up provision on the remaining 4.9 million shares of GTC common stock held by us and allocated to Genzyme General, which is approximately 17% of the shares of GTC common stock outstanding as of June 30, 2003. We accounted for our investment in GTC under the equity method of accounting until May 2002, at which point our ownership interest and board representation was reduced below 20% and we did not have any other factors of significant influence. Accordingly, we ceased to have significant influence over GTC and we began accounting for our investment in GTC under the cost method of accounting in June 2002. Equity in net loss of unconsolidated affiliates in our consolidated statements of operations and the combined statements of operations of Genzyme General include charges of $1.0 million for the three months and $2.1 million for the six months ended June 30, 2002, representing our portion of the losses of GTC.
In January 2002, we formed Peptimmune as our wholly-owned subsidiary, by contributing $5.0 million of cash and $0.3 million of other assets to Peptimmune in exchange for 5.5 million shares of Peptimmune's Series A voting preferred stock and 100 shares of Peptimmune common stock. We allocated our investment in Peptimmune to Genzyme General. We consolidated the results of Peptimmune through February 2003 because during that period we owned 100% of its outstanding stock. In March 2003, our investment in Peptimmune decreased to approximately 12% as a result of the sale by Peptimmune of shares of its Series B voting preferred stock to third party investors. In accordance with our policy pertaining to affiliate sales of stock, we recorded a $2.9 million net gain ($4.5 million pre-tax) due to this sale, which was recorded as an increase to Genzyme General's investment in Peptimmune in other noncurrent assets and an increase to other comprehensive income in division equity in Genzyme General's combined balance sheet. Although our ownership interest in Peptimmune has declined below 20%, we account for our investment in Peptimmune under the equity
90
method of accounting because certain factors exist that cause us to continue to have significant influence over Peptimmune, including that the chairman, president and chief executive officer of Peptimmune is a member of our board of directors, one of our corporate officers is a consultant to Peptimmune and we have service agreements with Peptimmune. Our equity in the net losses of Peptimmune have not been significant to date.
Gain on Investment in Equity Securities
At December 31, 2002, the remaining 4.9 million shares of GTC common stock that we held did not qualify as marketable securities under SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," because we were within the first 12 months of the 24-month lock-up provision described above. As a result, we carried our investment in GTC on our consolidated balance sheets and the combined balance sheets of Genzyme General at cost, subject to review for impairment. Effective April 4, 2003, we began the last 12 months of the 24-month lock-up provision and, as a result, the remaining shares of GTC common stock that we hold now qualify as marketable securities under SFAS No. 115 and are carried on our consolidated balance sheets and the combined balance sheets of Genzyme General at fair value.
We review the carrying value of each of our strategic investments in equity securities on a quarterly basis for potential impairment. In June 2003, we recorded a $3.6 million impairment charge in connection with our investment in the common stock of ABIOMED because we considered the decline in value of this investment to be other than temporary. Given the significance and duration of the decline as of June 30, 2003, we concluded that it was unclear over what period the recovery of the stock price for this investment would take place, and, accordingly, that any evidence suggesting that the investment would recover to at least our historical cost was not sufficient to overcome the presumption that the current market price was the best indicator of the value of this investment.
At June 30, 2003, Genzyme General's division equity includes $16.4 million of unrealized gains and $0.3 million of unrealized losses related to our other investments in equity securities, all of which are allocated to Genzyme General. We believe the losses related to our other investments in equity securities are temporary.
Other
Genzyme General periodically enters foreign currency forward contracts, all of which have durations of less than three months. These contracts have not been designated as hedges and, accordingly, unrealized gains or losses on these contracts are reported in current earnings. The notional settlement value of foreign currency forward contracts outstanding as of June 30, 2003 is $52.0 million. At June 30, 2003 and 2002, the contracts fair value, representing an unrealized gain or loss, was not significant in each period presented.
For the three months ended June 30, 2003, Genzyme General also recorded in other in our consolidated statements of operations and the combined statements of operations of Genzyme General an unrealized gain of $0.8 million to reflect the change in value of our warrants to purchase shares of GTC common stock from April 1, 2003 to June 30, 2003, as compared to an unrealized loss of $0.9 million for the same period of 2002.
For the six months ended June 30, 2003, Genzyme General recorded an unrealized gain of $0.9 million to reflect the change in value of our warrants to purchase shares of GTC common stock from January 1, 2003 to June 30, 2003, as compared to an unrealized loss of $2.1 million for the same period of 2002.
91
Investment Income
Genzyme General's investment income decreased slightly for the three months ended June 30, 2003 and 7% for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to a decrease in interest rates, despite higher average cash balances.
Interest Expense
Genzyme General's interest expense decreased 7% for the three and six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to a slight decline in debt balances outstanding resulting from the repayment, in 2002, of notes payable, aggregating $7.0 million, assumed in connection with our acquisitions of Novazyme in September 2001 and GelTex in December 2000.
Tax Provision
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
|||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
|||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||
Provision for income taxes | $ | (29,378 | ) | $ | (17,964 | ) | 64 | % | $ | (54,869 | ) | $ | (29,979 | ) | 83 | % | |
Effective tax rate | 32 | % | 29 | % | 31 | % | 30 | % |
Genzyme General's tax rates for all periods vary from the U.S. statutory tax rate as a result of its:
The decrease in our tax rate for the three and six months ended June 30, 2003, as compared to the same period of 2002, is primarily due to increased benefits from orphan drug credits.
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GENZYME BIOSURGERY
A Division of Genzyme Corporation
The following discussion summarizes the key factors our management believes necessary for an understanding of Genzyme Biosurgery's financial statements. When reviewing this discussion, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under "Factors Affecting Future Operating Results" below. These risks and uncertainties could cause our actual results to differ materially from those forecast in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward-looking statements under "Note Regarding Forward-Looking Statements." These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock. Options and warrants to purchase shares of Biosurgery Stock were converted into options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock, no shares remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Biosurgery are now allocated to Genzyme General. We have deregistered Biosurgery Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangement previously approved by our board of directors that had made a portion of Genzyme General's cash available to Genzyme Biosurgery.
Effective July 1, 2003, in connection with the elimination of our tracking stock structure, we will cease allocating earnings to Biosurgery Stock. From that date forward, all of our earnings will be allocated to Genzyme General Stock. Earnings allocated to Biosurgery Stock prior to July 1, 2003 will not be affected by the elimination of our tracking stock structure. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and management's discussion and analysis for Genzyme Biosurgery but will continue to provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES
The critical accounting policies and significant estimates for Genzyme Biosurgery are set forth under the heading "Management's Discussion and Analysis of Genzyme Biosurgery's Financial Condition and Results of OperationsCritical Accounting Policies and Significant Estimates" in Exhibit 13.3 to our 2002 Form 10-K. There have been no changes to these policies and no significant changes to these estimates since December 31, 2002.
DISPOSITION
On June 30, 2003, we sold substantially all of the tangible and intangible assets directly associated with our cardiac devices business, excluding our Fall River, Massachusetts manufacturing facility, the assets related to our FocalSeal product line and certain other assets, to Teleflex, for $32.8 million in cash. In addition, Teleflex assumed $6.3 million of trade obligations directly associated with our cardiac
93
devices business. The sale was completed on June 30, 2003 after banking hours and, as a result, the proceeds were not received until July 1, 2003. We recorded the proceeds as a receivable due from Teleflex in our consolidated balance sheet and the combined balance sheet of Genzyme Biosurgery at June 30, 2003. The assets sold had a net carrying value of $68.1 million at the time of the sale. We recorded a net loss of $29.4 million in our consolidated statements of operations and in the combined statements of operations of Genzyme Biosurgery in June 2003 in connection with this sale. Teleflex is leasing the manufacturing facility that we own in Fall River, Massachusetts through December 2004 with an option to extend the term to June 30, 2005. We have also entered into several transitional services agreements with Teleflex under which we will each provide and receive certain services for specified periods of time and fees as described in the agreements.
REVENUES
The components of Genzyme Biosurgery's total revenues are described in the following table:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
|||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
|||||||||||||||
|
(Amounts in thousands, except percentage data) |
||||||||||||||||||
Product revenue: | |||||||||||||||||||
Orthopaedics | $ | 29,633 | $ | 25,767 | 15 | % | $ | 55,987 | $ | 45,765 | 22 | % | |||||||
Biosurgical Specialties | 12,514 | 11,724 | 7 | % | 24,618 | 21,714 | 13 | % | |||||||||||
Cardiac Science | 44 | | N/A | 56 | | N/A | |||||||||||||
Cardiac Devices | 19,488 | 19,733 | (1 | )% | 38,468 | 37,908 | 1 | % | |||||||||||
Total product revenue | 61,679 | 57,224 | 8 | % | 119,129 | 105,387 | 13 | % | |||||||||||
Service revenue: |
|||||||||||||||||||
Orthopaedics | 5,531 | 4,728 | 17 | % | 11,598 | 8,905 | 30 | % | |||||||||||
Biosurgical Specialties | 649 | 876 | (26 | )% | 1,622 | 1,907 | (15 | )% | |||||||||||
Cardiac Science | 11 | | N/A | 14 | | N/A | |||||||||||||
Cardiac Devices | 1 | | N/A | 1 | | N/A | |||||||||||||
Total service revenue | 6,192 | 5,604 | 10 | % | 13,235 | 10,812 | 22 | % | |||||||||||
Research and development revenue: |
|||||||||||||||||||
Orthopaedics | 116 | | N/A | 546 | | N/A | |||||||||||||
Biosurgical Specialties | 687 | 35 | 1,863 | % | 1,373 | 35 | 3,823 | % | |||||||||||
Cardiac Science | 84 | | N/A | 101 | | N/A | |||||||||||||
Total research and development revenue | 887 | 35 | 2,434 | % | 2,020 | 35 | 5,671 | % | |||||||||||
Total revenues | $ | 68,758 | $ | 62,863 | 9 | % | $ | 134,384 | $ | 116,234 | 16 | % | |||||||
Product Revenue
In January 2003, as a result of a change in how Genzyme Biosurgery reviews its business, Genzyme Biosurgery reallocated:
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Genzyme Biosurgery has reclassified its 2002 disclosures to conform to its 2003 presentation.
Orthopaedics product revenue increased 15% to $29.6 million for the three months and 22% to $56.0 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to increased sales of Synvisc viscosupplementation product. Synvisc viscosupplementation product sales increased in each period primarily due to increased utilization of the product within the existing customer base as well as the creation of new accounts. We believe that a significant competitor is currently seeking FDA approval for a viscosupplementation product that could have an adverse affect on future sales of Synvisc viscosupplementation product.
Biosurgical Specialties product revenue increased 7% to $12.5 million for the three months and 13% to $24.6 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to 22% increases in the sales of Sepra products to $11.4 million for the three months and $21.8 million for the six months ended June 30, 2003, primarily due to increased market penetration.
Cardiac Devices product revenue remained stable for the three and six months ended June 30, 2003 as compared to the same periods of 2002.
Service Revenue
Orthopaedics service revenue increased 17% to $5.5 million for the three months and 30% to $11.6 million for the six months ended June 30, 2003, as compared to the same periods a year ago, primarily due to the reclassification of $1.6 million for the three months and $3.2 million for the six months ended June 30, 2003 of reimbursed expenses from partners as service revenue.
Biosurgical Specialties service revenue decreased 26% to $0.6 million for the three months and 15% to $1.6 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to decreased sales of Epicel skin grafts, which are used to treat victims of severe burns. Sales of Epicel skin grafts are variable based upon a number of unpredictable factors, including the number of severe burn patients and their survival rate prior to treatment with Epicel skin grafts.
Research and Development Revenue
Orthopaedics research and development revenue is primarily due to reimbusements received from a partner for development projects associated with Synvisc viscosupplementation product beginning in 2003. Biosurgical Specialties research and development revenue is primarily due to a milestone payment received for Hylaform biomaterial product.
International Revenue
International product and service revenue as a percentage of total product and service revenue for the three months ended June 30, 2003 was 30% as compared to 27% in the same period of 2002. International product and service revenue as a percentage of total product and service revenue for the six months ended June 30, 2003 was 30% as compared to 29% in the same period of 2002.
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MARGINS
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Product margin | $ | 36,568 | $ | 31,467 | 16 | % | $ | 68,760 | $ | 55,075 | 25 | % | ||||||
% of product revenue | 59 | % | 55 | % | 58 | % | 52 | % | ||||||||||
Service margin |
$ |
3,417 |
$ |
2,019 |
69 |
% |
$ |
6,946 |
$ |
4,194 |
66 |
% |
||||||
% of service revenue | 55 | % | 36 | % | 52 | % | 39 | % | ||||||||||
Total product and service gross margin |
$ |
39,985 |
$ |
33,486 |
19 |
% |
$ |
75,706 |
$ |
59,269 |
28 |
% |
||||||
% of total product and service revenue | 59 | % | 53 | % | 57 | % | 51 | % |
Product Margin
Genzyme Biosurgery sells or provides a broad range of healthcare products and services. As a result, Genzyme Biosurgery's gross margins may vary significantly depending on the market conditions of each product or service.
The increases in product margin and in product margin as a percentage of product revenue for the three and six months ended June 30, 2003, as compared to the same periods of 2002, are primarily attributable to an increase in product revenue of $4.5 million for the three months and $13.7 million for the six months ended June 30, 2003.
Service Margin
Service margin for services allocated to Genzyme Biosurgery increased 69% for the three months ended June 30, 2003, compared to the same periods of 2002, and service margin as a percentage of service revenue increased during this period primarily due to a 17% increase in sales of Orthopaedics services for the three months ended June 30, 2003, as compared to the same period in 2002. This increase is a result of the classification of $1.6 million for the three months ended June 30, 2003 of reimbursed expenses from partners as service revenue.
Service margin for services allocated to Genzyme Biosurgery increased 66% for the six months ended June 30, 2003 as compared to the same periods of 2002 and service margin as a percentage of service revenue increased during this period primarily due to a 30% increase in sales of Orthopaedics services for the six months ended June 30, 2003 as compared to the same periods in 2002. This increase is a result of the classification of $3.2 million for the six months ended June 30, 2003 of reimbursed expenses from partners as service revenue.
OPERATING EXPENSES
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased 20% for the three months ended June 30, 2003 as compared to the same period of 2002 and increased 16% for the six months ended June 30, 2003 as compared to the same period of 2002. The increases were primarily due to the creation of a sales force and an increase in sales operations in France in the first half of 2003 as we began to sell Synvisc viscosupplementation product directly to customers rather than through a distributor effective January 1, 2003. Also contributing to these increases was the classification of $1.6 million for the three months and $3.2 million for the six months ended June 30, 2003 of reimbursed expenses from partners as service revenue. These increases were partially offset by an overall decrease in expenses related to the Cardiac Devices business primarily due to increased operating efficiencies and reductions in staffing in 2002.
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Research and Development Expenses
Research and development expenses increased 15% for the three months ended June 30, 2003 as compared to the same period of 2002. The increase was primarily due to a $1.8 million increase in spending on the Orthopaedics business product development programs, particularly other indications for Synvisc viscosupplementation product and a $1.3 million increase in the Cardiac Science business product development programs, particularly cardiac cell therapy, as a result of clinical trials initiated in November 2002. These increases were partially offset by a $1.1 million decrease in the Biosurgical Specialties business product development programs, particularly, clinical trials for Sepragel spine which were terminated in 2002.
Research and development expenses increased 16% for the six months ended June 30, 2003 as compared to the same period of 2002. The increase was primarily due to a $3.1 million increase in spending on the Orthopaedics business product development programs, particularly other indications for Synvisc viscosupplementation product and a $2.4 million increase in the Cardiac Science business product development programs, particularly cardiac cell therapy, as a result of clinical trials initiated in November 2002. These increases were partially offset by a $1.2 million decrease in the Biosurgical Specialties business product development programs, particularly, clinical trials for Sepragel spine which were terminated in 2002.
Amortization of Intangibles
There was no significant change in amortization of intangibles expense for the three and six months ended June 30, 2003, as compared to the same periods of 2002.
Charge for Impairment of Goodwill
In connection with our assessment of the value of Genzyme Biosurgery and the elimination of our tracking stock structure, we determined that the fair value of Genzyme Biosurgery's net assets was lower than their carrying value, indicating a potential impairment of the goodwill allocated to Genzyme Biosurgery's orthopaedics reporting unit, which resulted from our acquisition of Biomatrix in December 2000. Based on the analysis performed to date, we have concluded that the goodwill assigned to Genzyme Biosurgery's orthopaedics reporting unit is fully impaired. Accordingly, we recorded an estimated charge for impairment of goodwill of $102.8 million in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery in June 2003 to write off the goodwill allocated to Genzyme Biosurgery's orthopaedics reporting unit.
Charge for Impaired Asset
In connection with the sale of assets to Teleflex, we tested the carrying value of our manufacturing facility in Fall River, Massachusetts in June 2003 to determine whether the impairment recognition criteria in SFAS No. 144, "Accounting for the Impairment of Disposal of Long-Lived Assets," had been met. In evaluating the facility for impairment, we considered the risks associated with the eventual sale of this facility, including the probability of finding a buyer for the facility, the amount of time that would likely be required to market and complete the sale of the facility and the estimated range of net proceeds that we could expect to receive. Our impairment analysis indicated that the carrying value for the Fall River facility would not be fully recoverable. As a result of this assessment, we recorded a charge for impaired asset of $2.9 million in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery in June 2003 to write down the carrying value of the Fall River facility to its estimated fair value.
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Purchase of In-Process Research And Development
Biomatrix
In connection with our acquisition of Biomatrix, we allocated approximately $82.1 million to IPR&D, which Genzyme Biosurgery recorded as a charge to expense in its combined statement of operations for the year ended December 31, 2000. As of June 30, 2003, the technological feasibility of the Biomatrix IPR&D projects had not yet been reached and no significant departures from the assumptions included in the valuation analysis had occurred.
Below is a brief description of the Biomatrix IPR&D projects, including an estimation of when our management believes we may realize revenues from the sales of these products in the respective application:
Program |
Program Description or Indication |
|
Development Status at June 30, 2003 |
Value at Acquisition Date |
Estimated Cost to Complete at June 30, 2003 |
Year of Expected Product Launch |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
(in millions) |
|
|||||||||
Viscosupplementation | Use of elastoviscous solutions and viscoelastic gels in disease conditions to supplement tissues and body fluids, alleviating pain and restoring normal function. | |
Received conditional FDA approval for hip indication clinical trial in United States Preclinical activities in the United States and clinical trial in Europe for knee indications Preclinical for other joints Product launched for hip indication in Europe in September 2002 |
$ | 33.8 | $ | 28.6 | 2002 to 2008 | ||||||
Visco-augmentation and Visco-separation (Adhesion prevention) | Use of viscoelastic gels to provide scaffolding for tissue regeneration and to separate tissues and decrease formation of adhesions and excessive scars after surgery. | |
Preclinicalgynecological and pelvic indications Clinical trialspivotal safety and efficacy study ongoing in United States for Hylaform biomaterials Phase 2spine indications; program cancelled during 2002; no further development planned |
48.3 N/A |
1.5 N/A |
2003 to 2004 N/A |
||||||||
$ | 82.1 | $ | 30.1 | |||||||||||
Except for our viscosupplementation product for the hip launched in Europe in 2002, substantial additional research and development will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give assurances that these programs will ever reach feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially affected.
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OTHER INCOME AND EXPENSES
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Loss on sale of product line | $ | (29,367 | ) | $ | | N/A | $ | (29,367 | ) | $ | | N/A | ||||||
Other | (5 | ) | 78 | (106 | )% | (35 | ) | 111 | (132 | )% | ||||||||
Investment income | 253 | 326 | (22 | )% | 472 | 623 | (24 | )% | ||||||||||
Interest expense | (1,987 | ) | (2,361 | ) | (16 | )% | (4,180 | ) | (4,606 | ) | (9 | )% | ||||||
Total other income (expenses) | $ | (31,106 | ) | $ | (1,957 | ) | 1,489 | % | $ | (33,110 | ) | $ | (3,872 | ) | 755 | % | ||
Investment Income
Investment income decreased in the three and six months ended June 30, 2003 as compared to the same periods of 2002 as a result of a decrease in interest rates.
Interest Expense
Interest expense decreased in the three and six months ended June 30, 2003 as compared to the same periods of 2002 primarily as a result of a decrease in interest rates used to calculate interest on borrowings from our revolving credit facility and the satisfaction of the $10.0 million, 6.9% convertible subordinated note in May 2003, assumed in connection with our acquisition of Biomatrix.
CUMULATIVE EFFECT OF CHANGE IN ACCOUNTING FOR GOODWILL
On January 1, 2002, we adopted SFAS No. 142, which requires that ratable amortization of goodwill and certain intangible assets be replaced with periodic tests of goodwill's impairment and that other intangible assets be amortized over their useful lives unless these lives are determined to be indefinite. SFAS No. 142 requires a transitional impairment test to compare the fair value of a reporting unit with the carrying amount of the goodwill.
Upon adoption of SFAS No. 142, Genzyme Biosurgery tested the goodwill of the cardiothoracic reporting unit in accordance with the transitional provisions of that standard, using the present value of expected future cash flows to estimate the fair value of this reporting unit. Genzyme Biosurgery recorded an impairment charge of $98.3 million, which was reflected as a cumulative effect of a change in accounting for goodwill in our consolidated statements of operations and the combined statements of operations for Genzyme Biosurgery in March 2002.
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GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
The following discussion summarizes the key factors our management believes are necessary for an understanding of Genzyme Molecular Oncology's financial statements. When reviewing this discussion, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under "Factors Affecting Future Operating Results" below. These risks and uncertainties could cause actual results to differ materially from those forecast in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward-looking statements under "Note Regarding Forward-Looking Statements." These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated) and we undertake no obligation to update or revise the statements in light of future developments.
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options to purchase shares of Molecular Oncology Stock were exchanged for options to purchase shares of Genzyme General Stock. While our charter continues to designate 40,000,000 shares as Molecular Oncology Stock, no shares remain outstanding effective July 1, 2003, and all of our assets and liabilities that had been allocated to Genzyme Molecular Oncology are now allocated to Genzyme General. We have deregistered Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. The elimination of our tracking stock structure will impact our consolidated balance sheet and earnings allocations beginning July 1, 2003. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions and the interdivisional financing arrangement, previously approved by our board of directors, that had made a portion of Genzyme General's cash available to Genzyme Molecular Oncology.
Effective July 1, 2003, in connection with the elimination of our tracking stock structure, we will cease allocating earnings to Molecular Oncology Stock. From that date forward, all of our earnings will be allocated to Genzyme General Stock. Earnings allocated to Molecular Oncology Stock prior to July 1, 2003 will not be affected by the elimination of our tracking stock structure. In future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate financial statements and management's discussion and analysis for Genzyme Molecular Oncology but will continue to provide our consolidated financial statements and management's discussion and analysis for our corporation as a whole.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES
The critical accounting policies and significant estimates for Genzyme Molecular Oncology are set forth under the heading "Management's Discussion and Analysis of Genzyme Molecular Oncology's Financial Condition and Results of OperationsCritical Accounting Policies and Significant Estimates" in Exhibit 13.4 to our 2002 Form 10-K. There have been no changes to these policies and no significant changes to these estimates since December 31, 2002.
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REVENUES
The components of Genzyme Molecular Oncology's total revenues are described in the following table:
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Service revenue | $ | 37 | $ | 185 | (80 | )% | $ | 37 | $ | 485 | (92 | )% | ||||||
Research and development revenue | 1,777 | 1,469 | 21 | % | 3,254 | 2,938 | 11 | % | ||||||||||
Licensing revenue | 661 | 673 | (2 | )% | 1,365 | 1,326 | 3 | % | ||||||||||
Royalty revenue | 7 | 19 | (63 | )% | 14 | 19 | (26 | )% | ||||||||||
Total revenues | $ | 2,482 | $ | 2,346 | 6 | % | $ | 4,670 | $ | 4,768 | (2 | )% | ||||||
Service revenue consists of revenues from the provision of services related to the SAGE genomics technology. Genzyme Molecular Oncology provides these services sporadically as customers request them. The focus of its SAGE business remains directed to the grant of licenses to the technology.
Research and development revenue for both the three and six months ended June 30, 2003 and 2002 consists of revenue for research performed on behalf of:
Licensing revenue for both the three and six months ended June 30, 2003 and 2002 consisted primarily of technology access fees Genzyme Molecular Oncology received from Purdue and Kirin Brewery Co. Ltd. upon entering those collaborations. Genzyme Molecular Oncology is amortizing these fees over the course of the associated research programs. For the three and six months ended June 30, 2003, Genzyme Molecular Oncology recognized $0.6 million and $1.3 million of the technology access fees it received from Purdue and Kirin Brewery Co. Ltd., consistent with the same periods of 2002. Genzyme Molecular Oncology also recognizes licensing revenue from licenses of rights to the SAGE technology.
Royalty revenue consists of royalties received under licenses to the SAGE technology.
COST OF REVENUES
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Increase/ (Decrease) % Change |
Increase/ (Decrease) % Change |
||||||||||||||||
|
2003 |
2002 |
2003 |
2002 |
||||||||||||||
|
(Amounts in thousands, except percentage data) |
|||||||||||||||||
Cost of services sold | $ | 17 | $ | 168 | (90 | )% | $ | 17 | $ | 287 | (94 | )% | ||||||
Cost of revenue from research and development contracts, licensing and royalty revenue | 1,156 | 1,167 | (1 | )% | 2,328 | 2,302 | 1 | % | ||||||||||
Total cost of revenues | $ | 1,173 | $ | 1,335 | (12 | )% | $ | 2,345 | $ | 2,589 | (9 | )% | ||||||
Genzyme Molecular Oncology's cost of services sold consists of costs associated with the performance of services using the SAGE technology.
Genzyme Molecular Oncology's cost of research and development contracts, licensing and royalty revenue for the three and six months ended June 30, 2003 and 2002 includes:
101
OPERATING EXPENSES
Selling, General and Administrative Expenses
Genzyme Molecular Oncology's selling, general and administrative expenses decreased 20% to $1.7 million for the three months ended June 30, 2003 and 18% to $3.4 million for the six months ended June 30, 2003, as compared to the same periods of 2002, primarily due to continued efforts within Genzyme Molecular Oncology to manage overall expenses and available cash.
Research and Development Expenses
Genzyme Molecular Oncology's research and development expenses decreased for both the three and six months ended June 30, 2003 by 22% to $4.1 million and $8.3 million, as compared to the same periods of 2002. Total research and development expenses, including collaborator-funded expenses, decreased 18% and 17% to $5.3 million and $10.7 million for the three and six months ended June 30, 2003. These decreases are primarily due to a planned reduction in research and development spending as part of efforts to conserve available cash.
OTHER INCOME AND EXPENSES
Genzyme Molecular Oncology's other income decreased 51% and 48% to $0.1 million and $0.2 million for the three and six months ended June 30, 2003, as compared to $0.2 million and $0.4 million in the same periods of 2002, primarily due to a decrease in investment income. Investment income decreased as a result of lower average cash balances.
102
B. LIQUIDITY AND CAPITAL RESOURCES
GENZYME CORPORATION
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. In the aggregate, 1,997,392 shares of Genzyme General Stock were exchanged for the outstanding shares of Biosurgery Stock and 959,045 shares of Genzyme General Stock were exchanged for the outstanding shares of Molecular Oncology Stock. Options and warrants to purchase shares of Biosurgery Stock, and options to purchase shares of Molecular Oncology Stock, were exchanged for options and warrants to purchase shares of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding effective July 1, 2003, and all of our assets and liabilities are now allocated to Genzyme General. We have deregistered Biosurgery Stock and Molecular Oncology Stock under the Securities Exchange Act of 1934, as amended. Because we now have only one series of common stock outstanding, we rescinded the management and accounting policies that governed the relationships between our divisions. As a result of the elimination of our tracking stock structure, in future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate liquidity and capital resources discussions and analyses for each of our divisions but will continue to provide the liquidity and capital resources discussion and analysis for our corporation as a whole.
At June 30, 2003 we had cash, cash equivalents, and short- and long-term investments of $1.3 billion, an increase of $96.7 million from December 31, 2002.
Our operating activities generated $163.1 million of cash for the six months ended June 30, 2003 as compared to $63.4 million for the same period of 2002. Net cash provided by operating activities was favorably impacted by:
These favorable impacts were offset, in part, by our net loss of $29.2 million, deferred tax benefits of $20.4 million and a $9.5 million net increase in certain working capital accounts.
Our investing activities utilized $299.0 million in cash for the six months ended June 30, 2003, as compared to the $80.9 million of cash for the same period of 2002. Net cash utilized by investing activities consists primarily of:
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In June 2003, we exercised our option to acquire a 50% interest in Dyax Corporation's DX-88 program for the potential treatment of hereditary angioedema, or HAE, and other chronic inflammatory diseases. Under the terms of the joint venture, both companies will share development costs of DX-88 for HAE going forward. In addition, Dyax Corporation, or Dyax, will receive milestone payments from us upon dosing the first HAE patient in a pivotal clinical trial of DX-88 and upon regulatory approval for the first indication. Dyax will also receive milestone payments from us if DX-88 is approved in additional chronic inflammatory indications. Contingent upon regulatory approval of DX-88 for HAE, we will market the product worldwide. Both companies will share equally in profits from sales of DX-88 for HAE and/or other chronic inflammatory diseases. In March 2003, Dyax exercised an option to acquire from us all rights to DX-88 for surgical indications.
Our financing activities provided $51.7 million in cash for the six months ended June 30, 2003 as compared to $58.0 million in cash for the same period of 2002. Cash provided from financing activities is primarily the result of:
The cash provided by our financing activities was partially offset by $10.4 million in cash utilitzed to repay debt and capital lease obligations, of which $10.0 million was used in May 2003 to satisfy the 6.9% convertible subordinated note assumed in connection with our acquisition of Biomatrix.
We have access to a $350.0 million revolving credit facility, all of which matures in December 2003. During the second quarter of 2003, we drew down $16.0 million under this facility. At June 30, 2003, $300.0 million remained outstanding under this facility, all of which was repaid on August 11, 2003. Borrowings under this facility bear interest at LIBOR plus an applicable margin, which was, in the aggregate, 2.5% at June 30, 2003. The terms of the revolving credit facility include various covenants, including financial covenants, which require us to meet minimum liquidity and interest coverage ratios and to meet maximum leverage ratios. We currently are in compliance with these covenants. We intend to refinance our revolving credit facility prior to its expiration in December 2003.
The disclosure of payments we have committed to make under our contractual obligations is set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of OperationsLiquidity and Capital Resources" in Exhibit 13.1 to our 2002 Form 10-K. Excluding the additional $16.0 million drawn under our revolving credit facility, the subsequent repayment of the entire $300.0 million principal balance outstanding under this facility and the payment of the 6.9% convertible subordinated note all described above, there have been no material changes to our contractual obligations since December 31, 2002.
We believe that our available cash, investments and cash flow from operations will be sufficient to fund our planned operations and capital requirements for the foreseeable future. Although we currently have substantial cash resources and positive cash flow, we intend to use substantial portions of our available cash for:
On August 13, 2003, we launched an all cash tender offer for all of the outstanding shares of SangStat for $22.50 per outstanding share, or approximately $600 million. The transaction, which we expect to be completed in September 2003, is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. This transaction, if completed, will use a significant portion of our
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cash resources. In addition, our cash reserves may be further reduced to pay principal and interest on the $575.0 million in principal under our 3% convertible subordinated debentures due May 15, 2021, which may be converted into shares of Genzyme General Stock. Holders of the debentures may require us to repurchase all or part of their debentures for cash on May 15, 2006, 2011 or 2016, at a price equal to 100% of the principal amount of the debentures plus accrued interest through the date prior to the date of repurchase. Additionally, if certain fundamental changes occur, each holder may require us to repurchase, for cash, all or a portion of the holder's debentures. On or after May 20, 2004, we may redeem for cash all or part of the debentures that have not previously been converted or repurchased. The redemption price would be 100.75% of the principal amount if redeemed from May 20, 2004 through May 14, 2005, and 100% of the principal amount thereafter.
To satisfy these and other commitments, we may have to obtain additional financing. We cannot guarantee that we will be able to obtain any additional financing, extend any existing financing arrangement, or obtain either on favorable terms.
Two lawsuits have been filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock. The first case, filed in Massachusetts Superior Court on May 28, 2003, is a purported class action on behalf of holders of Biosurgery Stock alleging a breach of an implied covenant of good faith and fair dealing in our charter and a breach of our board of directors' fiduciary duties. The plaintiff in this case is seeking an injunction to adjust the exchange ratio for the tracking stock exchange. We filed our answer to this complaint on July 21, 2003. The second case, filed in the United States District Court for the Southern District of New York on June 3, 2003, was brought by two holders of Biosurgery Stock alleging violations of federal securities laws as well as a breach of an implied covenant of good faith and fair dealing in our charter, a breach of our board of directors' fiduciary duties, common law fraud, and a breach of the merger agreement with Biomatrix. The plaintiffs sought an injunction to prevent the tracking stock exchange, but they withdrew that motion on June 19, 2003. The plaintiffs are also seeking an adjustment to the exchange ratio, the rescission of the acquisition of Biomatrix, and unspecified compensatory damages. We filed a motion to dismiss this complaint on July 2, 2003. Rather than reply to this motion, the plaintiffs amended their complaint on August 1, 2003. This amended complaint asserts class action status and, except for the rescission of the Biomatrix acquisition, seeks the same relief as the original complaint. We believe both cases are without merit and plan on defending against them vigorously. We are not able to predict the outcome of these cases or estimate the amount or range of any possible loss we might incur if we do not prevail in the final, non-appealable determinations of these matters. Therefore, we have not accrued any amounts in connection with this contingency.
In 2001, Genzyme Limited, our wholly-owned subsidiary in the United Kingdom, established a home nursing and infusion service to support patients receiving Cerezyme enzyme and our other enzyme replacement therapies following the expiration of a contract with a third party service provider. This third party lodged a complaint with the Office of Fair Trading in the United Kingdom. The OFT is a non-governmental organization empowered to enforce certain consumer and competition legislation in the United Kingdom. The OFT commenced an investigation of this service, alleging that it contravened competition laws in the United Kingdom. While we believe that the provision of home healthcare services by our subsidiary and our pricing for Cerezyme enzyme in the United Kingdom fully complies with applicable laws, we cooperated in this investigation. In March 2003, the OFT ruled that this service did, in fact, violate United Kingdom competition law, and as a result fined Genzyme Limited approximately 6.8 million Pounds Sterling and required modifications to our pricing structure for Cerezyme enzyme in the United Kingdom. We have appealed this finding to the United Kingdom Competition Appeal Tribunal, receiving an automatic stay of the fine, and seeking a stay of the order on Cerezyme pricing. Hearings were held in April 2003 and May 2003 regarding the stay of the OFT's decision. In May 2003, the Tribunal issued an order that stays the OFT's decision but which requires Genzyme Limited to provide one supplier a modest discount during the pendency of the appeal process. Genzyme Limited filed its appeal brief in May 2003 and expects the appeal hearing to take
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place in September 2003. We are confident that we will prevail on appeal and believe it probable that we will not have to pay a material fine or permanently modify our Cerezyme pricing structure. We have not accrued any amounts in connection with this contingency.
The staff of the FTC is investigating our acquisition of Novazyme. The FTC is one of the agencies responsible for enforcing federal antitrust laws. While we do not believe that the acquisition should be deemed to contravene antitrust laws, we have been cooperating with the FTC in its investigation which is currently ongoing.
In April 2002, SPI initiated dispute resolution procedures alleging that we breached representations and warranties and committed fraud and intentional misconduct relating to the sale of our Snowden-Pencer line of surgical instruments to SPI in November 2001. An arbitration hearing is ongoing. We believe the claims made by SPI are without merit and intend to vigorously defend the claims. Based on the advice of counsel, management does not believe that it is probable that we will be required to pay a material amount in connection with this claim. We have not accrued any amounts in connection with this contingency.
Recent Accounting Pronouncements
In November 2002, the EITF published Issue No. 00-21, "Accounting for Revenue Arrangements with Multiple Deliverables," or EITF Issue No. 00-21, which addresses how to determine whether a revenue arrangement involving multiple deliverables contains more than one unit of accounting for the purposes of revenue recognition and how the revenue arrangement consideration should be measured and allocated to the separate units of accounting. EITF Issue No. 00-21 applies to all revenue arrangements that we enter into after June 30, 2003. We do not expect EITF Issue No. 00-21 to have a material impact on our financial condition or results of operations.
In January 2003, the FASB issued FIN 46, "Consolidation of Variable Interest Entities, an interpretation of Accounting Research Bulletin No. 51." FIN 46 requires existing unconsolidated variable interest entities to be consolidated by their primary beneficiaries if the entities do not effectively disperse risks among parties involved. Variable interest entities that effectively disperse risk will not be consolidated unless a single party holds an interest or combination of interests that effectively recombines risks that were previously dispersed. FIN 46 also requires enhanced disclosure requirements related to variable interest entities. FIN 46 applies immediately to variable interest entities created after January 31, 2003, and to variable interest entities in which an enterprise obtains an interest after that date. It applies in the first fiscal year or interim period beginning after June 15, 2003 to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. We are currently evaluating the impact of adopting FIN 46.
In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity." SFAS No. 150 requires that certain financial instruments, which under previous guidance were accounted for as equity, must now be accounted for as liabilities. The financial instruments affected include mandatorily redeemable stock, certain financial instruments that require or may require the issuer to buy back some of its shares in exchange for cash or other assets and certain obligations that can be settled with shares of stock. SFAS No. 150 is effective for all financial instruments entered into or modified after May 31, 2003 and must be applied to our existing financial instruments effective July 1, 2003, the beginning of the first fiscal period after June 15, 2003. We do not expect SFAS No. 150 to have a material impact on our financial condition or results of operations.
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GENZYME GENERAL
A Division of Genzyme Corporation
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock. As a result of the elimination of our tracking stock structure, in future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide separate liquidity and capital resources discussions and analyses for each of our divisions but will continue to provide the liquidity and capital resources discussion and analysis for our corporation as a whole. The full discussion of our liquidity and capital resources as of June 30, 2003 is described under the caption "Liquidity and Capital Resources-Genzyme Corporation" above. We encourage you to read this discussion.
At June 30, 2003, Genzyme General had cash, cash equivalents, and short- and long-term investments of $1.3 billion, an increase of $114.8 million from December 31, 2002.
Genzyme General's operating activities generated $185.0 million of cash for the six months ended June 30, 2003 as compared to $97.4 for the same period of 2002. Net cash provided by operating activities was favorably impacted by Genzyme General's division net income of $120.6 million, and:
These favorable impacts were offset by $6.4 million of deferred tax benefits.
Genzyme General's investing activities utilized $309.1 million of cash for the six months ended June 30, 2003 as compared to $59.1 million for the same period of 2002. Net cash utilized in investing activities consisted primarily of:
Genzyme General's financing activities provided $46.0 million of cash for the six months ended June 30, 2003, as compared to $47.8 million provided for the same period of 2002. Cash provided by financing activities was primarily the result of $44.7 million of cash provided from the issuance of common stock.
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GENZYME BIOSURGERY
A Division of Genzyme Corporation
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Biosurgery Stock for shares of Genzyme General Stock. As a result of the elimination of our tracking stock structure, in future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide a separate liquidity and capital resources discussion and analysis for Genzyme Biosurgery but will continue to provide the liquidity and capital resources discussion and analysis for our corporation as a whole. The full discussion of our liquidity and capital resources as of June 30, 2003 is described under the caption "Liquidity and Capital Resources-Genzyme Corporation" above. We encourage you to read this discussion.
At June 30, 2003, Genzyme Biosurgery had cash and cash equivalents of $26.9 million, a decrease of $5.8 million from December 31, 2002.
Genzyme Biosurgery's operating activities used $9.6 million of cash for the six months ended June 30, 2003, as compared to $18.0 million for the same period of 2002. Net cash used by operating activities was unfavorably impacted by Genzyme Biosurgery's division net loss of $166.7 million. This unfavorable impact was offset by:
Genzyme Biosurgery's investing activities utilized $1.4 million in cash for the six months ended June 30, 2003 as compared to $1.9 million for the same period of 2002.
Genzyme Biosurgery's financing activities provided $5.6 million in cash for the six months ended June 30, 2003, as compared to $10.1 million for the same period of 2002. Net cash provided from financing activities was primarily a result of $16.0 million of proceeds from our draw on our revolving credit facility. This was partially offset by $10.0 million of cash used to satisfy the 6.9% convertible subordinated note assumed in connection with our acquisition of Biomatrix.
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GENZYME MOLECULAR ONCOLOGY
A Division of Genzyme Corporation
Effective July 1, 2003, we completed the process to eliminate our tracking stock capital structure by exchanging, in accordance with the provisions of our charter, each share of Molecular Oncology Stock for shares of Genzyme General Stock. As a result of the elimination of our tracking stock structure, in future Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, we will not provide a separate liquidity and capital resources discussion and analysis for Genzyme Molecular Oncology but will continue to provide the liquidity and capital resources discussion and analysis for our corporation as a whole. The full discussion of our liquidity and capital resources as of June 30, 2003 is described under the caption "Liquidity and Capital Resources-Genzyme Corporation" above. We encourage you to read this discussion.
At June 30, 2003, Genzyme Molecular Oncology had cash and cash equivalents of $0.8 million, a decrease of $12.3 million from December 31, 2002.
Genzyme Molecular Oncology's operating activities used $12.3 million of cash for the six months ended June 30, 2003, as compared to $16.0 million for the same period of 2002. Net cash used by operating activities was impacted by Genzyme Molecular Oncology's division net loss of $9.2 million and by $3.1 million attributable to a net increase in certain working capital accounts in the same period.
Genzyme Molecular Oncology's investing activities provided $11.5 million of cash for the six months ended June 30, 2003, as compared to utilizing $19.9 million in the same period of 2002. Net cash provided by investing activities was attributable to the sales and maturities of investments.
Genzyme Molecular Oncology's financing activities for the six months ended June 30, 2003 provided $0.1 million of allocated proceeds from the issuance of Molecular Oncology Stock under our stock purchase program.
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FACTORS AFFECTING FUTURE OPERATING RESULTS
A reduction in revenue from sales of products that treat Gaucher disease would have an adverse effect on our business.
We generate a significant portion of our product revenue from sales of enzyme-replacement products for patients with Gaucher disease. We entered this market in 1991 with Ceredase enzyme. Because production of Ceredase enzyme was subject to supply constraints, we developed Cerezyme enzyme, a recombinant form of the enzyme. Recombinant technology uses specially engineered cells to produce enzymes, or other substances, by inserting into the cells of one organism the genetic material of a different species. In the case of Cerezyme enzyme, scientists engineer Chinese hamster ovary cells to produce human beta glucocerebrosidase. We stopped producing Ceredase enzyme, except for small quantities, during 1998, after substantially all the patients who previously used Ceredase enzyme converted to Cerezyme enzyme. Sales of Ceredase enzyme and Cerezyme enzyme totaled $619.2 million for the year ended December 31, 2002, representing approximately 47% of our consolidated revenues for that year.
Because our business is highly dependent on Cerezyme enzyme, a decline in the growth rate of Cerezyme enzyme sales could have an adverse effect on our operations and may cause the value of our securities to decline substantially. We will lose revenues from Cerezyme enzyme if competitors develop alternative treatments for Gaucher disease and these alternative products gain commercial acceptance. Some companies have initiated efforts to develop competitive products, and other companies may do so in the future. Celltech Group plc and Actelion Ltd., for example, are developing Zavesca, a small molecule drug candidate for the treatment of Gaucher disease. Zavesca has been approved by both the FDA and the European Commission as an oral therapy for use in patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. Celltech/Actelion are required to submit follow-up safety data on the product as a condition of such approval. Teva Pharmaceuticals, a licensee of Celltech, has received marketing approval of Zavesca in Israel.
Although orphan drug status for Cerezyme enzyme, which provided us with exclusive marketing rights for Cerezyme enzyme in the United States, expired in May 2001, we continue to have patents protecting our method of manufacturing Cerezyme enzyme until 2010 and the composition of Cerezyme enzyme until 2013. The expiration of market exclusivity and orphan drug status in May 2001 will likely subject Cerezyme enzyme to increased competition, which may decrease the amount of revenue we receive from this product or the growth of that revenue.
In addition, the patient population with Gaucher disease is limited. Because a significant percentage of that population already uses Cerezyme enzyme, opportunities for future sales growth are limited. Further, changes in the methods for treating patients with Gaucher disease, including treatment protocols that combine Cerezyme enzyme with other therapeutic products or reduce the amount of Cerezyme enzyme prescribed, could result in a decline in Cerezyme enzyme sales.
Our future earnings growth will depend on our ability to increase sales of Renagel phosphate binder.
We currently market Renagel phosphate binder, a non-absorbed phosphate binder which has been approved for use by patients with end-stage renal disease undergoing a form of treatment known as hemodialysis. We are currently conducting additional clinical trials in order to determine the efficacy and safety of Renagel phosphate binder when administered to pre-dialysis patients. Our ability to increase sales of Renagel phosphate binder will depend on a number of factors, including:
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A failure to increase sales of Synvisc viscosupplementation product could have a negative effect on our business.
Failure to achieve sales growth for Synvisc viscosupplementation product may adversely affect our business. Revenues from Synvisc viscosupplementation product could be impacted negatively if current or newly developed competitive treatments for the symptoms of osteoarthritis of the knee are deemed more efficacious, more convenient to use or more cost effective. Products competitive to Synvisc viscosupplementation product are currently being sold. Companies are developing other competitive products, and other companies may do so in the future. The commercial success of Synvisc viscosupplementation product also will depend on many other factors, including the availability of third-party reimbursement and continued relations with our marketing partners, particularly Wyeth.
If our strategic alliances to develop and commercialize products are unsuccessful, our earnings growth will be limited.
Several of our strategic initiatives involve alliances with other biotechnology and pharmaceutical companies. These include:
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We plan to enter into additional alliances in the future. The success of many of these arrangements is largely dependent on technology and other intellectual property contributed by our strategic partners to the alliances or the resources, efforts and skills of our partners. Our strategic partners may:
If any of these alliances are terminated and we lose access to the underlying intellectual property, or if we and our partners are unable to successfully develop or commercialize products, our future earnings will be adversely affected.
Government regulation imposes significant costs and restrictions on the development and commercialization of our products and services.
Our success will depend on our ability to satisfy regulatory requirements. We may not receive required regulatory approvals on a timely basis or at all. Government agencies heavily regulate the production and sale of healthcare products and the provision of healthcare services. In particular, the FDA and comparable agencies in foreign countries must approve human therapeutic and diagnostic products before they are marketed, as well as the facilities in which they are made. This approval process can involve lengthy and detailed laboratory and clinical testing, sampling activities and other costly and time-consuming procedures. This regulation may delay the time at which a company like Genzyme can first sell a product or may limit how a consumer may use a product or service or may adversely impact third-party reimbursement. A company's failure to comply with applicable regulatory approval requirements may lead regulatory authorities to take action against the company, including:
Furthermore, therapies that have received regulatory approval for commercial sale may continue to face regulatory difficulties. The FDA and comparable foreign regulatory agencies, for example, may require post-marketing clinical trials or patient outcome studies. In addition, regulatory agencies subject a marketed therapy, its manufacturer and the manufacturer's facilities to continual review and periodic inspections. The discovery of previously unknown problems with a therapy, the therapy's manufacturer or the facility used to produce the therapy could prompt a regulatory authority to impose restrictions on the therapy, manufacturer or facility, including withdrawal of the therapy from the market.
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In addition, our results may be adversely affected by any new laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, which relate to health care availability or the method of delivery or payment for our products and services, or which affect the sales and marketing practices involving, or pricing of, our products and services.
Legislative changes may adversely impact our business.
The FDA has designated some of our products, including Fabrazyme, Aldurazyme and Myozyme enzymes, as orphan drugs under the Orphan Drug Act. The Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases, generally by entitling the first developer that receives FDA marketing approval for an orphan drug to a seven-year exclusive marketing period in the United States for that product. In recent years Congress has considered legislation to change the Orphan Drug Act to shorten the period of automatic market exclusivity and to grant marketing rights to simultaneous developers of the drug. If the Orphan Drug Act is amended in this manner, any drugs for which we have been granted exclusive marketing rights under the Orphan Drug Act will face increased competition, which may decrease the amount of revenue we receive from these products. In addition, the United States government has shown significant interest in pursuing healthcare reform. Any government-adopted reform measures could adversely affect:
If the United States government significantly reduces the amount we may charge for our products, or the amount of reimbursement available for purchases of our products declines, our future revenues may decline and we may need to revise our research and development programs.
The development of our products involves a lengthy and complex process, and we may be unable to commercialize any of the products we are currently developing.
Before we can commercialize our development-stage products, we will need to:
This process involves a high degree of risk and takes several years. Our product development efforts may fail for many reasons, including:
For these reasons, and others, we may not successfully commercialize any of the products we are currently developing.
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Any marketable products that we develop may not be commercially successful.
Even if we obtain regulatory approval for any of our development-stage products, those products may not be accepted by the market or approved for reimbursement by third-party payers. A number of factors may affect the rate and level of market acceptance of these products, including:
If our products fail to achieve market acceptance, our profitability and financial condition will suffer.
We will require significant additional financing, which may not be available or available on terms favorable to us.
As of June 30, 2003, we had approximately $1.3 billion in cash, cash equivalents and short- and long-term investments, excluding investments in equity securities. We intend to use substantial portions of our available cash for:
On August 13, 2003, we launched an all cash tender offer for the outstanding shares of SangStat Medical Corporation, or SangStat, for $22.50 per outstanding SangStat share, or approximately $600 million. The transaction, which we expect to be completed in September 2003, is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. This transaction, if completed, will use a significant portion of our cash resources.
We may further reduce available cash reserves to pay principal and interest on the following debt:
If we use cash to pay or redeem all or a portion of this debt, including the principal and interest due on it, our cash reserves will be diminished.
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To satisfy these and other commitments, we may have to obtain additional financing. We may be unable to obtain any additional financing, extend any existing financing arrangement, or obtain either on terms that we consider favorable.
We may fail to adequately protect our proprietary technology, which would allow competitors or others to take advantage of our research and development efforts.
Our long-term success largely depends on our ability to market technologically competitive products. If we fail to obtain or maintain adequate intellectual property protection, we may not be able to prevent third parties from using our proprietary technologies. Our currently pending or future patent applications may not result in issued patents. In the United States, patent applications are confidential for 18 months following their filing, and because third parties may have filed patent applications for technology covered by our pending patent applications without us being aware of those applications, our patent applications may not have priority over any patent applications of others. In addition, our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. If a third party initiates litigation regarding our patents, our collaborators' patents, or those patents for which we have license rights, and is successful, a court could revoke our patents or limit the scope of coverage for those patents.
The United States Patent and Trademark Office, commonly referred to as the USPTO, and the courts have not consistently treated the breadth of claims allowed in biotechnology patents. If the USPTO or the courts begin to allow broader claims, the incidence and cost of patent interference proceedings and the risk of infringement litigation will likely increase. On the other hand, if the USPTO or the courts begin to allow narrower claims, the value of our proprietary rights may be limited. Any changes in, or unexpected interpretations of, the patent laws may adversely affect our ability to enforce our patent position.
We also rely upon trade secrets, proprietary know-how and continuing technological innovation to remain competitive. We protect this information with reasonable security measures, including the use of confidentiality agreements with our employees, consultants and corporate collaborators. It is possible that these individuals will breach these agreements and that any remedies for a breach will be insufficient to allow us to recover our costs. Furthermore, our trade secrets, know-how and other technology may otherwise become known or be independently discovered by our competitors.
We may be required to license technology from competitors or others in order to develop and commercialize some of our products and services, and it is uncertain whether these licenses will be available.
Third-party patents may cover some of the products or services that we or our strategic partners are developing or testing. For example, the USPTO has issued several patents generally relating to human recombinant alpha-L-iduronidase, the enzyme on which Aldurazyme enzyme is based. These patents are owned or controlled by one of our competitors. We believe that these patents do not validly cover the manufacture, use or sale of Aldurazyme enzyme. In addition, we are aware of a recently-issued United States patent owned by Columbia University relating to the manufacture of recombinant proteins in CHO cells. While we are currently licensed under that patent and obligated to pay royalties to Columbia in order to manufacture certain of our enzyme replacement therapies, we are challenging the validity of this patent in a federal lawsuit filed in June 2003.
A United States patent is entitled to a presumption of validity, and we cannot guarantee that, if we were to elect to challenge the validity of such a patent, we would be successful in doing so. In addition, even if we are successful in challenging the validity of a patent, the challenge itself may be expensive and require significant management attention.
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To the extent valid third party patent rights cover our products or services, we or our strategic collaborators would be required to obtain licenses from the holders of these patents in order to use, manufacture or sell these products and services, and payments under these licenses may reduce our revenue from these products. Furthermore, we may not be able to obtain these licenses on acceptable terms or at all. If we fail to obtain a required license or are unable to alter the design of our technology to fall outside of a patent, we may be unable to effectively market some of our products and services, which could limit our profitability.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
A third party may sue us or one of our strategic collaborators for infringing the third-party's patent rights. Likewise, we or one of our strategic collaborators may need to resort to litigation to enforce patent rights or to determine the scope and validity of third-party proprietary rights. If we do not prevail in this type of litigation, we or our strategic collaborators may be required to:
Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue some of our operations. In addition, a court may require that we pay expenses or damages and litigation could disrupt our commercial activities.
We may be liable for product liability other claims not covered by insurance.
Individuals who use our products or services, including those we acquire in business combinations, may bring product liability claims against us or our subsidiaries. In addition, we may from time to time become subject to litigation brought by our suppliers, collaborators, competitors or shareholders. While we have taken, and continue to take, what we believe are appropriate precautions, we may be unable to avoid significant liability exposure. We have only limited amounts of insurance, which may not provide sufficient coverage against any claims that may be asserted. We may be unable to obtain additional insurance in the future, or we may be unable to do so on acceptable terms. Any additional insurance we do obtain may not provide adequate coverage against any asserted claims. In addition, regardless of merit or eventual outcome, product liability claims and other litigation may result in:
Our competitors in the biotechnology and pharmaceutical industries may have superior products, manufacturing capabilities or marketing position.
The human healthcare products and services industry is extremely competitive. Our competitors include major pharmaceutical companies and other biotechnology companies, including:
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Some of these competitors may have more extensive research and development, marketing and production capabilities. Some competitors also may have greater financial resources than we have. Our future success will depend on our ability to effectively develop and market our products against those of our competitors. If our products receive marketing approval, but cannot compete effectively in the marketplace, our profitability and financial position will suffer.
If we are unable to keep up with rapid technological changes, our products or services may become obsolete.
The field of biotechnology is characterized by significant and rapid technological change. Although we attempt to expand our technological capabilities in order to remain competitive, research and discoveries by others may make our products or services obsolete. For example, some of our competitors may develop a product to treat Gaucher disease that is more effective or less expensive than Cerezyme enzyme. If we cannot compete effectively in the marketplace, our profitability and financial position will suffer.
If we fail to obtain adequate levels of reimbursement for our products from third-party payers, the commercial potential of our products will be significantly limited.
A substantial portion of our revenue comes from payments by third-party payers, including government health administration authorities and private health insurers. As a result of the trend toward managed healthcare in the United States, as well as legislative proposals to reduce payments under government insurance programs, third-party payers are increasingly attempting to contain healthcare costs by:
Government and other third-party payers may not provide adequate insurance coverage or reimbursement for our products and services, which could impair our financial results. In addition, third-party payers may not reimburse patients for newly approved healthcare products, which could decrease demand for our products. Furthermore, Congress occasionally has discussed implementing broad-based measures to contain healthcare costs. It is possible that Congress will enact legislation specifically designed to contain healthcare costs. If third-party reimbursement is inadequate to allow us
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to recover our costs or if Congress passes legislation to contain healthcare costs, our profitability and financial condition will suffer.
Changes in the economic, political, legal and business environments in the foreign countries in which we do business could cause our international sales and operations, which account for a significant percentage of our consolidated net sales, to be limited or disrupted.
Our international operations accounted for approximately 40% of our consolidated product and service revenues for the year ended December 31, 2002. We expect that international product and service sales will continue to account for a significant percentage of our revenues for the foreseeable future. In addition, we have direct investments in a number of subsidiaries outside of the United States, primarily in the United Kingdom, the European Union, Latin America and Japan. Our international sales and operations could be limited or disrupted, and the value of our direct investments may be diminished, by any of the following:
A significant portion of our business is conducted in currencies other than our reporting currency, the U.S. Dollar. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. As a result, currency fluctuations among the U.S. Dollar and the currencies in which we do business have caused foreign currency transaction gains and losses in the past and will likely do so in the future. Because of the number of currencies involved, the variability of currency exposures and the potential volatility of currency exchange rates, we may suffer significant foreign currency transaction losses in the future due to the effect of exchange rate fluctuations on our future operating results.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to potential loss from financial market risks that may occur as a result of changes in interest rates, equity prices and foreign currency exchange rates. Our exposure to these risks has not materially changed since December 31, 2002.
We incorporate by reference our disclosure related to market risk which is set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of OperationsMarket Risk," "Interest Rate Risk," "Foreign Exchange Risk" and "Equity Price Risk" in Exhibit 13.1 to our 2002 Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
Our chief executive officer and our chief financial officer evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) as of a date (the "Evaluation Date") within 90 days before the filing date of this quarterly report. Based upon that evaluation, our chief executive officer and our chief financial officer have concluded that, as of the Evaluation Date, our disclosure controls and procedures were effective in ensuring that they received, in a timely manner, the information that we and our consolidated subsidiaries are required to disclose in the reports filed or submitted by us under the Securities Exchange Act of 1934. There were no significant changes in our internal controls or in other factors that could significantly affect our disclosure controls and procedures subsequent to the Evaluation Date.
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Two lawsuits have been filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock. The first case, filed in Massachusetts Superior Court on May 28, 2003, is a purported class action on behalf of holders of Biosurgery Stock alleging a breach of an implied covenant of good faith and fair dealing in our charter and a breach of our board of directors' fiduciary duties. The plaintiff in this case is seeking an injunction to adjust the exchange ratio for the tracking stock exchange. We filed our answer to this complaint on July 21, 2003. The second case, filed in the United States District Court for the Southern District of New York on June 3, 2003, was brought by two holders of Biosurgery Stock alleging violations of federal securities laws as well as a breach of an implied covenant of good faith and fair dealing in our charter, a breach of our board of directors' fiduciary duties, common law fraud, and a breach of the merger agreement with Biomatrix. The plaintiffs sought an injunction to prevent the tracking stock exchange, but they withdrew that motion on June 19, 2003. The plaintiffs are also seeking an adjustment to the exchange ratio, the rescission of the acquisition of Biomatrix, and unspecified compensatory damages. We filed a motion to dismiss this complaint on July 2, 2003. Rather than reply to this motion, the plaintiffs amended their complaint on August 1, 2003. This amended complaint asserts class actions status and, except for the recission of the Biomatrix acquisition, seeks the same relief as the original complaint. We believe both cases are without merit and plan on defending against them vigorously.
In March 2003, the Office of Fair Trade in the United Kingdom issued a decision against our wholly-owned subsidiary, Genzyme Limited, finding that Genzyme Limited held a dominant position, abused that dominant position and had no objective justification for its conduct, in connection with its establishment and operation of a home nursing and infusion service to support patients receiving Cerezyme enzyme and our other enzyme replacement therapies. In conjunction with this decision, the OFT imposed a fine on Genzyme Limited and required modification of its pricing structure for Cerezyme enzyme in the United Kingdom. Genzyme Limited has appealed this finding to the United Kingdom Competition Appeal Tribunal, receiving an automatic stay of the fine, and seeking a stay of the order on Cerezyme pricing. Hearings were held in April 2003 and May 2003 regarding the stay of the OFT's decision. In May 2003 the Tribunal issued an order that stays the OFT's decision but which requires Genzyme Limited to provide one supplier a modest discount during the pendency of the appeal process. Genzyme Limited filed its appeal brief in May 2003 and expects the appeal hearing to take place in September 2003. We are confident that we will prevail on appeal and believe it probable that we will not have to pay a material fine or permanently modify our Genzyme pricing structure.
In April 2002, SPI, initiated dispute resolution procedures alleging that we breached representations and warranties and committed fraud and intentional misconduct relating to the sale of our Snowden-Pencer line of surgical instruments to SPI in November 2001. An arbitration hearing is ongoing. We believe the claims made by SPI are without merit and intend to vigorously defend against the claims.
We are currently a party to other legal proceedings as well. While our management currently believes that the ultimate outcome of any of these proceedings will not have a material adverse effect on our financial position or results of operations, litigation is subject to inherent uncertainty, and we could experience such a material adverse impact. In addition, litigation consumes both cash and management attention. For a discussion of certain other legal proceedings to which we are a party, please refer to Item 3., "Legal Proceedings," to our 2002 Form 10-K.
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On June 30, 2003, we completed a previously announced exchange of each share of Biosurgery Stock for 0.04914 of a share of Genzyme General Stock and each share of Molecular Oncology Stock for 0.05653 of a share of Genzyme General Stock. While our charter continues to designate 100,000,000 shares as Biosurgery Stock and 40,000,000 shares as Molecular Oncology Stock, no shares of either series remain outstanding, and all of our assets and liabilities are now allocated to the General Division. Accordingly, we filed a Form 15 with the SEC on July 1, 2003 with respect to Biosurgery Stock and Molecular Oncology Stock to deregister these series of stock under the Securities Exchange Act of 1934, as amended. In addition, because we now have only one series of common stock outstanding, we have rescinded the management and accounting policies which related to relationships between our divisions. We also have amended and restated our shareholder rights plan to eliminate the rights that had been associated with Biosurgery Stock and Molecular Oncology Stock.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
Number of Votes |
|||||
---|---|---|---|---|---|---|
Nominee |
||||||
For |
Withheld |
|||||
Victor J. Dzau, M.D. | ||||||
Genzyme General Stock | 162,736,088 | 20,769,279 | ||||
Genzyme Biosurgery Stock* | 2,440,198 | 494,722 | ||||
Genzyme Molecular Oncology Stock** | 929,059 | 126,287 | ||||
Total | 166,105,345 | 21,390,288 | ||||
|
Number of Votes |
|||||
---|---|---|---|---|---|---|
Nominee |
||||||
For |
Withheld |
|||||
Senator Connie Mack III | ||||||
Genzyme General Stock | 180,533,107 | 2,972,260 | ||||
Genzyme Biosurgery Stock* | 2,440,134 | 494,785 | ||||
Genzyme Molecular Oncology Stock** | 987,237 | 68,110 | ||||
Total | 183,960,478 | 3,535,155 | ||||
|
Number of Votes |
|||||
---|---|---|---|---|---|---|
Nominee |
||||||
For |
Withheld |
|||||
Henri A. Termeer | ||||||
Genzyme General Stock | 180,050,577 | 3,454,790 | ||||
Genzyme Biosurgery Stock* | 2,434,807 | 500,113 | ||||
Genzyme Molecular Oncology Stock** | 998,934 | 56,413 | ||||
Total | 183,484,318 | 4,011,316 | ||||
Each nominee received a majority of the votes cast, and therefore has been duly elected as a director of Genzyme. The terms of office for Douglas A. Berthiaume, Henry E. Blair, Constantine E. Anagnostopoulos, Robert J. Carpenter and Charles L. Cooney as directors of Genzyme continued after the annual meeting.
121
|
Number of Votes For |
Number of Votes Against |
Number of Votes Abstaining |
Number of Broker Non-Votes |
||||
---|---|---|---|---|---|---|---|---|
Genzyme General Stock | 178,182,295 | 4,043,938 | 1,277,133 | 2,001 | ||||
Biosurgery Stock* | 2,571,140 | 354,311 | 9,468 | | ||||
Molecular Oncology Stock** | 927,732 | 118,518 | 9,096 | | ||||
181,681,167 | 4,516,767 | 1,295,697 | 2,001 | |||||
The proposal received a majority of the votes cast, and therefore has been adopted.***
|
Number of Votes For |
Number of Votes Against |
Number of Votes Abstaining |
Number of Broker Non-Votes |
||||
---|---|---|---|---|---|---|---|---|
Genzyme General Stock | 178,164,610 | 4,047,382 | 1,291,374 | 2,001 | ||||
Biosurgery Stock* | 2,577,271 | 348,585 | 9,064 | | ||||
Molecular Oncology Stock** | 925,534 | 119,961 | 9,850 | | ||||
181,667,415 | 4,515,928 | 1,310,288 | 2,001 | |||||
The proposal received a majority of the votes cast, and therefore has been adopted.***
|
Number of Votes For |
Number of Votes Against |
Number of Votes Abstaining |
Number of Broker Non-Votes |
||||
---|---|---|---|---|---|---|---|---|
Genzyme General Stock | 178,163,370 | 4,045,692 | 1,294,304 | 2,001 | ||||
Biosurgery Stock* | 2,571,001 | 354,059 | 9,859 | | ||||
Molecular Oncology Stock** | 925,628 | 120,776 | 8,942 | | ||||
181,659,999 | 4,520,527 | 1,313,105 | 2,001 | |||||
The proposal received a majority of the votes cast, and therefore has been adopted.***
|
Number of Votes For |
Number of Votes Against |
Number of Votes Abstaining |
Number of Broker Non-Votes |
||||
---|---|---|---|---|---|---|---|---|
Genzyme General Stock | 94,859,716 | 55,067,539 | 3,091,750 | 30,486,362 | ||||
Biosurgery Stock* | 1,077,158 | 752,674 | 28,053 | 1,157,033 | ||||
Molecular Oncology Stock** | 259,046 | 172,123 | 27,463 | 596,713 | ||||
96,195,920 | 55,992,336 | 3,147,266 | 32,240,108 | |||||
The proposal received a majority of the votes cast, and therefore has passed.***
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
See the Exhibit Index following the signature page to this report on Form 10-Q
On April 16, 2003, we furnished a Current Report on Form 8-K dated April 16, 2003 to report under Items 7 and 9 the issuance of press releases announcing the anticipated results of operations of our Genzyme General, Genzyme Biosurgery and Genzyme Molecular Oncology divisions for the three month period ended March 31, 2003.
On May 8, 2003, we filed a Current Report on Form 8-K dated May 8, 2003 to report under Item 5 the decision by our board of directors to exchange all of the outstanding shares of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock effective June 30, 2003.
On May 28, 2003, we filed a Current Report on Form 8-K dated May 28, 2003 to report under Item 5 the filing in Massachusetts Superior Court of a lawsuit on behalf of holders of Biosurgery Stock related to the elimination of our tracking stock structure.
On July 1, 2003, we filed a Current Report on Form 8-K dated June 30, 2003 to report under Item 5 the completion of the exchange of all of the outstanding shares of Biosurgery Stock and Molecular Oncology Stock for shares of Genzyme General Stock.
On July 16, 2003, we furnished a Current Report on Form 8-K dated July 16, 2003 to report under items 7 and 9 the issuance of a press release announcing the anticipated results of operations of our Genzyme General, Genzyme Biosurgery and Genzyme Molecular Oncology divisions for the three and six month periods ended June 30, 2003.
123
GENZYME CORPORATION AND SUBSIDIARIES
FORM 10-Q, JUNE 30, 2003
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.
GENZYME CORPORATION | ||||
By: |
/s/ MICHAEL S. WYZGA Michael S. Wyzga Executive Vice President, Finance, Chief Financial Officer, and Chief Accounting Officer |
|||
DATE: August 13, 2003 |
124
GENZYME CORPORATION AND SUBSIDIARIES
FORM 10-Q, JUNE 30, 2003
Exhibit No. |
Description |
|
---|---|---|
*3.1 | Restated Articles of Organization of Genzyme Corporation, as amended. Filed as Exhibit 3 to Genzyme's Form 8-K filed on June 6, 2001. | |
*3.2 |
By laws of Genzyme, as amended. Filed as Exhibit 3.2 to Genzyme's Form 10-Q for the quarter ended September 30, 1999. |
|
31.1 |
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
|
31.2 |
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
|
32.1 |
Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith. |
|
32.2 |
Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith. |