0000950135-95-001906.txt : 19950915 0000950135-95-001906.hdr.sgml : 19950915 ACCESSION NUMBER: 0000950135-95-001906 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19950630 FILED AS OF DATE: 19950913 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-14680 FILM NUMBER: 95573589 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 10-Q/A 1 GENZYME CORPORATION 1 FORM 10-Q/A ----------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 Amendment No. 1 to (X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1995 ------------------------------ OR ( ) 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 06-1047163 -------------------------------------------------------------------------------- (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) One Kendall Square, Cambridge, Massachusetts 02139 -------------------------------------------------------------------------------- (Address of principal executive offices) (zip code) (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 X No ----- ----- The number of shares outstanding of each of the issuer's classes of common stock as of June 30, 1995:
Class Outstanding at June 30, 1995: ----- ----------------------------- General Division Common Stock, $0.01 par value ("General Division Stock") 26,754,922 Tissue Repair Division Common Stock, $0.01 par value ("TR Stock") 8,818,362
Total number of pages in document - 28 No exhibits filed herewith. 2 GENZYME CORPORATION AND SUBSIDIARIES FORM 10-Q/A, JUNE 30, 1995 This report on Form 10-Q/A constitutes Amendment No. 1 to the registrant's Form 10-Q for the fiscal quarter ended June 30, 1995. The items hereby amended are as follows: -- Item 1 is deleted in its entirety and replaced with the following. -2- 3 GENZYME CORPORATION AND SUBSIDIARIES FORM 10-Q/A, JUNE 30, 1995 TABLE OF CONTENTS
PAGE NO. -------- PART I. FINANCIAL INFORMATION ITEM 1. Unaudited Condensed Financial Statements GENZYME CORPORATION AND SUBSIDIARIES Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 1995 and 1994............. 4 Condensed Consolidated Balance Sheets as of June 30, 1995 and December 31, 1994........................................ 6 Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 1995 and 1994........................... 7 Notes to Unaudited Condensed Consolidated Financial Statements.... 8 Management's Discussion and Analysis of Financial Condition and Results of Operations......................................... 10 GENZYME GENERAL DIVISION Condensed Combined Statements of Operations for the Three and Six Months Ended June 30, 1995 and 1994............. 13 Condensed Combined Balance Sheets as of June 30, 1995 and December 31, 1994........................................ 15 Condensed Combined Statements of Cash Flows for the Six Months Ended June 30, 1995 and 1994........................... 16 Notes to Unaudited Condensed Combined Financial Statements ...... 17 Management's Discussion and Analysis of Financial Condition and Results of Operations......................................... 19 GENZYME TISSUE REPAIR DIVISION Condensed Combined Statements of Operations for the Three and Six Months Ended June 30, 1995 and 1994............. 22 Condensed Combined Balance Sheets as of June 30, 1995 and December 31, 1994........................................ 23 Condensed Combined Statements of Cash Flows for the Six Months Ended June 30, 1995 and 1994........................... 24 Notes to Unaudited Condensed Combined Financial Statements ...... 25 Management's Discussion and Analysis of Financial Condition and Results of Operations......................................... 26 Signatures............................................................. 28
-3- 4 GENZYME CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED (DOLLARS IN THOUSANDS) JUNE 30, JUNE 30, --------------------------------------------------------------------------------------------------- 1995 1994 1995 1994 ------- ------- -------- -------- Revenues: Net product sales................................ $75,301 $57,510 $144,602 $110,985 Net service sales................................ 11,801 13,079 24,265 27,007 Revenues from research and development contracts: Related parties................................ 6,497 4,405 12,823 9,983 Other.......................................... 6 384 104 685 ------- ------- -------- -------- 93,605 75,378 181,794 148,660 Operating costs and expenses: Cost of products sold............................ 30,843 22,180 56,974 40,825 Cost of services sold............................ 7,826 8,308 15,777 17,017 Selling, general and administrative.............. 25,902 20,466 51,893 42,922 Research and development (including research and development related to contracts)........... 17,263 13,088 33,726 26,016 ------- ------- -------- -------- 81,834 64,042 158,370 126,780 ------- ------- -------- -------- Operating income.................................. 11,771 11,336 23,424 21,880 Other income and (expenses): Minority interest in net loss of subsidiaries.... 501 304 866 617 Equity in net loss of unconsolidated affiliate... (793) - (1,742) - Investment income................................ 1,297 2,038 3,062 5,776 Interest expense................................. (173) (407) (220) (843) ------- ------- -------- -------- 832 1,935 1,966 5,550 ------- ------- -------- -------- Income before income taxes........................ 12,603 13,271 25,390 27,430 Provision for income taxes........................ (4,663) (4,778) (9,394) (9,875) ------- ------- -------- -------- Net income........................................ $ 7,940 $ 8,493 $ 15,996 $ 17,555 ======= ======= ======== ========
The accompanying notes are an integral part of these unaudited, condensed, consolidated financial statements. -4- 5 GENZYME CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (CONTINUED) (UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) JUNE 30, JUNE 30, -------------------------------------------------------------------------------------------------- 1995 1994 1995 1994 ---- ---- ---- ---- APPLICABLE TO GENZYME GENERAL DIVISION: Net income...................................... $10,932 $ 9,110 $21,303 $18,702 Allocated tax benefit generated by Genzyme Tissue Repair Division......................... 2,035 512 3,662 797 ------- ------- ------- ------- Net income attributable to General Division Stock............................... $12,967 $ 9,622 $24,965 $19,499 ======= ======= ======= ======= Per common and common equivalent share: Net income (1)................................. $ 0.46 $ 0.37 $ 0.89 $ 0.75 ======= ======= ======= ======= Average shares outstanding..................... 28,318 25,930 28,105 25,988 ======= ======= ======= ======= Per common share assuming full dilution: Net income (1)................................. $ 0.43 $ 0.35 $ 0.83 $ 0.70 ======= ======= ======= ======= Average fully diluted shares outstanding....... 30,323 27,821 30,235 27,879 ======= ======= ======= ======= APPLICABLE TO GENZYME TISSUE REPAIR DIVISION: Net loss attributable to TR Stock............... $(5,027) $(1,129) $(8,969) $(1,944) ======= ======= ======= ======= Per common share: Net loss....................................... $ (0.57) $ (0.34) $ (1.03) $ (0.59) ======= ======= ======= ======= Average shares outstanding..................... 8,763 3,292 8,721 3,287 ======= ======= ======= ======= (1) General Division 1994 net income per share is pro forma.
The accompanying notes are an integral part of these unaudited, condensed, consolidated financial statements. -5- 6 GENZYME CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(DOLLARS IN THOUSANDS) JUNE 30, DECEMBER 31, ------------------------------------------------------------------------------------------ 1995 1994 ---- ---- ASSETS Current Assets: Cash and cash equivalents................................ $ 31,548 $ 63,542 Short-term investments................................... 13,055 13,073 Accounts receivable, less allowance for doubtful accounts................................... 81,238 78,127 Inventories.............................................. 41,986 36,840 Prepaid expenses and other current assets................ 11,935 11,074 Deferred tax assets - current............................ 4,072 4,072 -------- -------- Total current assets................................... 183,834 206,728 Property, plant and equipment, net........................ 315,662 296,802 Other Assets: Long-term investments.................................... 58,005 76,845 Note receivable - related party.......................... 1,429 3,572 Intangibles, net of accumulated amortization............. 27,412 29,303 Deferred tax assets - noncurrent......................... 28,473 28,473 Other noncurrent assets.................................. 24,065 16,685 -------- -------- 139,384 154,878 -------- -------- $638,880 $658,408 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable......................................... $ 10,583 $ 21,387 Accrued expenses......................................... 33,468 30,986 Income taxes payable..................................... 1,359 6,523 Deferred revenue......................................... 2,601 2,604 Current portion of long-term debt and capital lease obligations............................... 927 41,357 -------- -------- Total current liabilities.............................. 48,938 102,857 Noncurrent Liabilities: Long-term debt and capital lease obligations............. 128,321 126,729 Other noncurrent liabilities............................. 8,759 7,548 -------- -------- 137,080 134,277 Minority interest in subsidiaries......................... 1,554 2,310 Stockholders' Equity: General Division Stock, $.01 par value................... 267 264 TR Stock, $.01 par value................................. 88 87 Treasury Stock - at cost................................. (825) (755) Additional paid-in capital............................... 477,899 470,826 Accumulated deficit...................................... (22,812) (38,808) Other equity adjustments................................. (3,309) (12,650) -------- -------- 451,308 418,964 -------- -------- $638,880 $658,408 ======== ========
The accompanying notes are an integral part of these unaudited, condensed, consolidated financial statements. -6- 7 GENZYME CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(DOLLARS IN THOUSANDS) SIX MONTHS ENDED JUNE 30, --------------------------------------------------------------------------------- 1995 1994 ---- ---- OPERATING ACTIVITIES: Net income......................................... $ 15,996 $ 17,555 Reconciliation of net income to net cash from operating activities: Depreciation and amortization.................... 11,595 8,240 Provision for bad debts.......................... 3,699 2,483 (Gain)/loss on sale of investments............... 110 (1,591) Loss on disposal of fixed assets................. 32 - Accrued interest/amortization on bonds........... 514 (2,795) Minority interest in net loss of subsidiaries.... (866) (616) Equity in net loss of unconsolidated affiliate... 1,742 - Other............................................ 1,173 11 Decrease in cash from working capital: Accounts receivable............................ (4,363) (9,550) Inventories.................................... (4,183) (7,524) Prepaid expenses and other current assets...... (710) (696) Accounts payable, accrued expenses and deferred revenue.......................... (14,738) (4,258) -------- --------- Net cash from operating activities............. 10,001 1,259 INVESTING ACTIVITIES: Investment in unconsolidated affiliate............. (4,000) - Loans to related parties........................... (1,857) - Purchases of investments........................... (22,027) (219,636) Sales and maturities of investments................ 45,918 246,723 Property, plant and equipment...................... (25,675) (68,940) Other noncurrent assets............................ (541) 2,901 -------- --------- Net cash from investing activities............. (8,182) (38,952) FINANCING ACTIVITIES: Issuance of common stock........................... 6,846 2,581 Issuance of common stock by subsidiary............. 260 - Issuance of debt................................... 77 21,614 Payments of debt and capital lease obligations..... (39,341) (360) -------- --------- Net cash from financing activities............. (32,158) 23,835 Effect of exchange rate changes on cash............. (1,655) (700) -------- --------- Decrease in cash and cash equivalents............... (31,994) (14,558) Cash and cash equivalents, beginning of period...... 63,542 22,975 -------- --------- Cash and cash equivalents, end of period............ $ 31,548 $ 8,417 ======== ========= Supplemental Cash Flow Information: Cash paid during the period for: Interest......................................... $ 5,197 $ 4,444 Income taxes..................................... 14,405 7,050 Supplemental Disclosure of Non-Cash Transactions: Additional investment in unconsolidated affiliate -- Note 6
The accompanying notes are an integral part of these unaudited, condensed, consolidated financial statements. -7- 8 GENZYME CORPORATION AND SUBSIDIARIES NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 1. Basis of Presentation: ---------------------- These unaudited, condensed, consolidated financial statements should be read in conjunction with the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1994 and the financial statements and footnotes included therein. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. Certain items in the 1994 financial statements have been reclassified to conform with the 1995 presentation. The financial statements for the three and six months ended June 30, 1995 and 1994 are unaudited but include, in the Company's opinion, all adjustments (consisting only of normally recurring accruals) necessary for a fair presentation of the results for the periods presented. 2. Accounting Policies: -------------------- The accounting policies underlying the quarterly financial statements are those set forth in Note A of the financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 1994. 3. Investments: ------------ As of June 30, 1995, the Company's investment portfolio, consisting primarily of debt securities classified as available for sale, was adjusted to its market value. As a result, gross unrealized holding gains of approximately $5,000 and gross unrealized holding losses totaling approximately $611,000 were recorded in a separate component of Stockholders' equity. As of June 30, 1995, the carrying values of the Company's investments in Argus Pharmaceuticals, Inc., Celtrix Pharmaceuticals, Inc. and Univax Biologics, Inc., included in Other noncurrent assets in the unaudited, condensed, consolidated balance sheets, were adjusted to their respective market values. Gross unrealized holding gains of approximately $414,000 and gross unrealized holding losses of approximately $1,714,000 were recorded in a separate component of Stockholders' equity. 4. Inventories: ------------
June 30, 1995 December 31, 1994 ------------- ----------------- Raw Materials............ $10,371,000 $14,572,000 Work-in-process.......... 14,374,000 9,247,000 Finished products........ 17,241,000 13,021,000 ----------- ----------- $41,986,000 $36,840,000 =========== ===========
5. Provision for Income Taxes: --------------------------- The tax provision for the quarter ended June 30, 1995 varies from the U.S. statutory tax rate because of the provision for state income taxes, losses of subsidiaries which generate no current tax benefit, tax credits and taxes on foreign earnings. The effective tax rate was 37% for the three and six months ended June 30, 1995 as compared to 36% for the corresponding periods in 1994. The increase was due primarily to the expiration of the Orphan Drug Credit effective December 31, 1994. -8- 9 6. Additional Investments in Unconsolidated Affiliate: --------------------------------------------------- In June 1995, the Company converted approximately $4.0 million of Genzyme Transgenics Corporation ("GTC") debt into equity through the acquisition of 1.3 million shares of GTC common stock. The transaction increased the Company's interest in GTC to 49%. On July 3, 1995, GTC acquired Biodevelopment Laboratories, Inc. ("BDL"). As part of the transaction, the Company issued approximately 34,000 shares of General Division Common Stock to former stockholders of BDL in exchange for approximately 475,000 shares of newly issued GTC stock. In total, GTC issued approximately 1,207,000 shares in the transaction, resulting in a decrease in the Company's interest in GTC to 48.2%. Also as part of the BDL transaction, the Company guaranteed a $7,500,000 line of credit to GTC from a commercial bank in return for warrants to purchase 145,000 shares of GTC stock. -9- 10 GENZYME CORPORATION AND SUBSIDIARIES MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 1995 RESULTS OF OPERATIONS Revenue ------- Total revenues for the three and six months ended June 30, 1995 were $93.6 million and $181.8 million, respectively, an increase of 24% and 22%, respectively, over the corresponding periods in 1994. Product and service revenues were $87.1 million and $168.9 million, respectively, an increase of 23% and 22% over the same periods in 1994. Product revenues increased 31% to $75.3 million for the second quarter, and 30% to $144.6 million for the six months ended June 30, 1995, reflecting sales increases in the Therapeutics, Diagnostic Products and Pharmaceuticals businesses of 26%, 26% and 78%, respectively, for the second quarter and 28%, 20% and 53%, respectively, for the six months ended June 30, 1995. The increase in sales of Therapeutic products resulted primarily from increased shipments of Ceredase[R] enzyme, for which the rate of new patient accruals more than offset dosage reductions, and the market introduction, in the second quarter of 1994, of Cerezyme[TM] enzyme, the recombinant form of Ceredase[R] enzyme. The increase in Diagnostic Product sales resulted from sales increases across most product lines including a doubling in revenues from sales of Direct LDL tests. The increase in Pharmaceutical sales resulted from the operations of a Swiss company acquired in July 1994. Diagnostic Service revenues for the second quarter and six months ended June 30, 1995 declined 10% to $11.8 million and $24.3 million, respectively, resulting primarily from the divestiture of two small genetic diagnostic laboratories and a decline in identity testing revenues. International sales represented approximately 41% and 42%, respectively, of product sales for the second quarter and six months ended June 30, 1995 compared with approximately 34% for the second quarter and six months ended June 30, 1994. The increase was due primarily to increases of 56% and 62%, respectively, for the quarter and six months ended June 30, 1995, in the combined international sales of Ceredase[R]/Cerezyme[TM] enzyme as well as favorable exchange rates. Revenues from research and development contracts for the three and six months ended June 30, 1995 were $6.5 million and $12.9 million, respectively, an increase of 36% and 21%, respectively, from the corresponding periods in 1994. Revenues from Neozyme II increased 49% to $6.0 million for the second quarter of 1995 due primarily to increased activity relating to collaborations with third parties. For the six months ended June 30, 1995, revenues from Neozyme II increased 40% to $11.7 million. In the first quarter of 1994, the Surgical Aids Partnership provided revenues to Genzyme of $0.9 million thereby exhausting the funds it had available for the funding of the HAL[TM] products. In the first six months of 1994, consolidation of the operations of Genzyme Transgenics Corporation ("GTC") provided $1.3 million of reported revenues from research and development contracts. Beginning in the fourth quarter of 1994, the Company accounts for GTC using the equity method of accounting and, accordingly, no longer reports GTC's revenue from research and development contracts. Margins and Operating Expenses ------------------------------ Total gross margin for the quarter and six months ended June 30, 1995 was 56% and 57%, respectively, as compared to 57% and 58%, respectively, for the same periods in 1994. Genzyme provides a broad range of health care products and services, resulting in a range of gross margins depending on the particular market conditions of each product or service. Product margins for the three and six months ended June 30, 1995 declined to 59% and 61%, respectively, from 61% and 63%, -10- 11 respectively, for the same periods in 1994 due primarily to a provision for obsolete Fine Chemicals inventory as the Company concentrates upon the Pharmaceuticals business. Diagnostic Service margins for the three and six months ended June 30, 1995 decreased to 34% and 35%, respectively, from 36% and 37%, respectively, due to high fixed costs associated with identity testing which experienced a decline in revenues relative to the same periods in 1994. Selling, general and administrative expenses for the three and six months ended June 30, 1995 were $25.9 million and $51.9 million, respectively, compared to $20.5 million and $42.9 million for the same periods in 1994. The increase was due primarily to increased staffing in support of the growth in several product lines and to the ongoing expenses associated with various operations acquired or established in 1994. As a percentage of total revenues, selling, general and administrative expenses for the three and six months ended June 30, 1995 were 28% and 29%, respectively, compared to 27% and 29%, respectively, for the corresponding periods in 1994. Research and development expenses for the three and six months ended June 30, 1995 were $17.3 million and $33.7 million, compared to $13.1 million and $26.0 million, respectively, for the same periods in 1994 due to increased efforts on behalf of Neozyme II, increased spending on internal programs and spending of $1,732,000 and $3,490,000, respectively, related to the operations of BioSurface Technology, Inc., acquired in December 1994. Other Income and Expenses ------------------------- Investment income for the quarter and six months ended June 30, 1995 totaled $1.3 million and $3.1 million, respectively, compared with $2.0 million and $5.8 million, respectively, for the same periods in 1994. Investment income for the three and six months ended June 30, 1995 includes losses on the sales of securities of $25,000 and $110,000, respectively, as compared to losses of $18,000 and gains of $1.6 million, respectively, on the sales of securities for the corresponding periods in 1994. Excluding the effect of these realized gains and losses, investment income for the six months ended June 30, 1995 decreased 24% due to lower average cash and investment balances. Interest expense for the quarter and six months ended June 30, 1995 was $173,000 and $220,000, respectively, net of capitalized interest on construction in progress of $2.3 million and $4.8 million, respectively. Interest relating to Genzyme's 6 3/4% convertible subordinated notes was $1.7 million and $3.4 million, respectively, equal to the amount incurred in the same periods in 1994. The Company also incurred interest expense for the three and six months ended June 30, 1995 of $0.4 million and $0.8 million, respectively, related to a $21.5 million mortgage note issued in the second quarter of 1994, $0.1 million and $0.2 million, respectively, related to a deferred liability established to acquire the remaining shares of a Swiss company acquired, in part, in July 1994 and the remainder related to interest on capitalized leases. The tax provision for the quarter ended June 30, 1995 varies from the U.S. statutory tax rate because of the provision for state income taxes, losses of subsidiaries which generate no current tax benefit, tax credits and taxes on foreign earnings. The effective tax rate was 37% for the three and six months ended June 30, 1995 as compared to 36% for the corresponding period in 1994. The increase was due primarily to the expiration of the Orphan Drug Credit effective December 31, 1994. LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1995, Genzyme had cash, cash equivalents and investments in marketable securities totaling $102.6 million, a decrease of $50.9 million from December 31, 1994. The Company repaid a $39.0 million term loan in January 1995. In the six months ended June 30, 1995, Genzyme spent $25.7 million on increased -11- 12 manufacturing capacity and invested an additional $4.0 million in GTC, an unconsolidated affiliate. These expenditures were financed partially by operations, $10.0 million, and by the issuance of common stock through exercises of stock options and warrants, $7.1 million. As of June 30, 1995, the Company had accounts receivable of $81.2 million, an increase of $3.1 million from December 31, 1994, due primarily to increased sales. Inventories increased $5.1 million, or 14%, to $42.0 million as of June 30, 1995 as compared to December 31, 1994. The increase was due primarily to improved Ceredase[R] yields and management's efforts to build Ceredase[R] inventories, support of increased business operations and, in part, to exchange rate fluctuations. In January 1995, the Company renewed its commitment to continue funding, until March 1, 1996, the development of the HAL[TM] products on behalf of the Surgical Aids Partnership whose available funds were fully expended in the first quarter of 1994. The Company is required to allocate up to $30 million in cash from the General Division during specified periods through June 1998 to fund GTR's operations, unless additional funds are raised from the sale of Tissue Repair Division Common Stock to outside investors or unless the cash balance of the General Division falls below $60 million. If the cash balance of the General Division is between $60 million and $90 million, the Funding Commitment will be reduced on a pro rata basis. The General Division's cash balance at June 30, 1995 was $86.4 million. -12- 13 GENZYME GENERAL DIVISION CONDENSED COMBINED STATEMENTS OF OPERATIONS (UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED (DOLLARS IN THOUSANDS) JUNE 30, JUNE 30, ---------------------------------------------------------------------------------------------------- 1995 1994 1995 1994 ---- ---- ---- ---- Revenues: Net product sales................................ $74,054 $57,510 $142,325 $110,985 Net service sales................................ 11,801 13,079 24,265 27,007 Revenues from research and development contracts: Related parties................................ 6,497 4,405 12,823 9,983 Other.......................................... 6 384 104 685 ------- ------- -------- -------- 92,358 75,378 179,517 148,660 Operating costs and expenses: Cost of products sold............................ 29,963 22,180 55,369 40,825 Cost of services sold............................ 7,826 8,308 15,777 17,017 Selling, general and administrative.............. 23,361 20,240 47,600 42,533 Research and development (including research and development related to contracts)........... 14,148 12,185 27,797 24,461 ------- ------- -------- -------- 75,298 62,913 146,543 124,836 ------- ------- -------- -------- Operating income.................................. 17,060 12,465 32,974 23,824 Other income and (expenses) Minority interest in net loss of subsidiaries.... 501 304 866 617 Equity in net loss of unconsolidated affiliate... (793) - (1,742) - Investment income................................ 1,035 2,038 2,481 5,776 Interest expense................................. (173) (407) (220) (843) ------- ------- -------- -------- 570 1,935 1,385 5,550 ------- ------- -------- -------- Income before income taxes........................ 17,630 14,400 34,359 29,374 Provision for income taxes........................ (6,698) (5,290) (13,056) (10,672) ------- ------- -------- -------- Net income........................................ 10,932 9,110 21,303 18,702 Allocated tax benefit generated by Tissue Repair Division........................... 2,035 512 3,662 797 ------- ------- -------- -------- Net income attributable to Genzyme General Division Stock........................... $12,967 $ 9,622 $ 24,965 $ 19,499 ======= ======= ======== ========
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -13- 14 GENZYME GENERAL DIVISION CONDENSED COMBINED STATEMENTS OF OPERATIONS (CONTINUED) (UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) JUNE 30, JUNE 30, -------------------------------------------------------------------------------------------------- 1995 1994 1995 1994 ---- ---- ---- ---- Net income attributable to Genzyme General Division Stock......................... $12,967 $ 9,622 $24,965 $19,499 ======= ======= ======= ======= Income per General Division common and common equivalent share: Net income (1)................................. $ 0.46 $ 0.37 $ 0.89 $ 0.75 ======= ======= ======= ======= Average shares outstanding..................... 28,318 25,930 28,105 25,988 ======= ======= ======= ======= Income per General Division Common Share assuming full dilution: Net income (1)................................. $ 0.43 $ 0.35 $ 0.83 $ 0.70 ======= ======= ======= ======= Average fully diluted shares outstanding....... 30,323 27,821 30,235 27,879 ======= ======= ======= ======= (1) Pro forma for 1994.
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -14- 15 GENZYME GENERAL DIVISION COMBINED BALANCE SHEETS (UNAUDITED)
(DOLLARS IN THOUSANDS), JUNE 30, DECEMBER 31, ----------------------------------------------------------------------------------------- 1995 1994 ---- ---- ASSETS Current Assets: Cash and cash equivalents............................... $ 26,286 $ 46,549 Short-term investments.................................. 4,051 7,155 Accounts receivable, less allowance for doubtful accounts.................................. 80,243 76,641 Inventories............................................. 41,876 36,764 Prepaid expenses and other current assets............... 11,747 10,790 Due from Genzyme Tissue Repair Division................. 826 171 Deferred tax assets - current........................... 4,072 4,072 -------- -------- Total current assets.................................. 169,101 182,142 Property, plant and equipment, net....................... 314,360 295,346 Other Assets: Long-term investments................................... 56,031 74,948 Note receivable - affiliate............................. 1,429 3,572 Intangibles, net of accumulated amortization............ 27,412 29,303 Deferred tax assets - noncurrent........................ 28,473 28,473 Other noncurrent assets................................. 23,748 16,360 -------- -------- 137,093 152,656 -------- -------- $620,554 $630,144 ======== ======== LIABILITIES AND DIVISION EQUITY Current Liabilities: Accounts payable........................................ $ 9,807 $ 20,859 Accrued expenses........................................ 31,884 27,766 Income taxes payable.................................... 1,359 6,523 Deferred revenue........................................ 2,601 2,604 Current portion of long-term debt and capital lease obligations.............................. 630 41,076 -------- -------- Total current liabilities............................. 46,281 98,828 Noncurrent Liabilities: Long-term debt and capital lease obligations............ 128,302 126,555 Other noncurrent liabilities............................ 8,031 6,800 -------- -------- 136,333 133,355 Minority interest in subsidiaries........................ 1,554 2,310 Division equity.......................................... 436,386 395,651 -------- -------- $620,554 $630,144 ======== ========
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -15- 16 GENZYME GENERAL DIVISION CONDENSED COMBINED STATEMENTS OF CASH FLOWS (UNAUDITED)
(DOLLARS IN THOUSANDS) SIX MONTHS ENDED JUNE 30, ---------------------------------------------------------------------------------- 1995 1994 ---- ---- OPERATING ACTIVITIES: Net income........................................... $ 24,965 $ 19,499 Reconciliation of net income to net cash from operating activities: Depreciation and amortization...................... 11,282 8,240 Provision for bad debts............................ 3,699 2,483 (Gain)/loss on sale of investments................. 110 (1,591) Loss on disposal of fixed assets................... 32 - Accrued interest/amortization on bonds............. 613 (2,795) Minority interest in net loss of subsidiaries...... (866) (616) Equity in net loss of unconsolidated affiliate..... 1,742 - Other.............................................. 1,173 11 Decrease in cash from working capital: Accounts receivable.............................. (4,854) (9,550) Inventories...................................... (4,149) (7,524) Prepaid expenses and other current assets........ (806) (696) Accounts payable, accrued expenses and deferred revenue............................ (13,350) (4,258) Due from Genzyme Tissue Repair Division.......... (655) - -------- --------- Net cash from operating activities............... 18,936 3,203 INVESTING ACTIVITIES: Investment in unconsolidated affiliate............... (4,000) - Loans to affiliate................................... (1,857) - Purchases of investments............................. (11,070) (219,636) Sales and maturities of investments.................. 37,831 246,723 Property, plant and equipment........................ (25,516) (68,940) Other noncurrent assets.............................. (549) 2,901 -------- --------- Net cash from investing activities............... (5,161) (38,952) -------- --------- FINANCING ACTIVITIES: Issuance of General Division Common Stock............ 6,461 2,581 Issuance of common stock by subsidiary............... 260 - Issuance of debt..................................... 77 21,614 Payments of debt and capital lease obligations....... (39,181) (388) Net cash to Genzyme.................................. - 28 -------- --------- Net cash from financing activities............... (32,383) 23,835 Effect of exchange rate changes on cash............... (1,655) (700) -------- --------- Decrease in cash and cash equivalents................. (20,263) (12,614) Cash and cash equivalents, beginning of period........ 46,549 22,975 -------- --------- Cash and cash equivalents, end of period.............. $ 26,286 $ 10,361 ======== ========= Supplemental Cash Flow Information: Cash paid during the period for: Interest........................................... $ 5,173 $ 4,444 Income taxes....................................... 14,405 7,050 Supplemental Disclosure of Non-Cash Transactions: Additional investment in unconsolidated affiliate -- Note 6
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -16- 17 GENZYME GENERAL DIVISION NOTES TO UNAUDITED CONDENSED COMBINED FINANCIAL STATEMENTS 1. Basis of Presentation: ---------------------- These unaudited, condensed, combined financial statements should be read in conjunction with the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1994 and the financial statements and footnotes for Genzyme General Division included therein. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. Certain items in the 1994 financial statements have been reclassified to conform with the 1995 presentation. The financial statements for the three and six months ended June 30, 1995 and 1994 are unaudited but include, in the Division's opinion, all adjustments (consisting only of normally recurring accruals) necessary for a fair presentation of the results for the periods presented. 2. Accounting Policies: -------------------- The accounting policies underlying the quarterly financial statements are those set forth in Note A of the General Division's financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 1994. 3. Investments: ------------ As of June 30, 1995, the General Division's investment portfolio, consisting primarily of debt securities classified as available for sale, was adjusted to its market value. As a result, gross unrealized holding gains of approximately $5,000 and gross unrealized holding losses totaling approximately $549,000 were recorded in a separate component of Division equity. As of June 30, 1995, the carrying values of the General Division's investments in Argus Pharmaceuticals, Inc., Celtrix Pharmaceuticals, Inc. and Univax Biologics, Inc., included in Other noncurrent assets in the unaudited, condensed, combined balance sheets, were adjusted to their respective market values. Gross unrealized holding gains of approximately $414,000 and gross unrealized holding losses of approximately $1,714,000 were recorded in a separate component of Division equity. 4. Inventories: ------------
June 30, 1995 December 31, 1994 ------------- ----------------- Raw Materials.............. $10,292,000 $14,517,000 Work-in-process............ 14,343,000 9,226,000 Finished products.......... 17,241,000 13,021,000 ----------- ----------- $41,876,000 $36,764,000 =========== ===========
5. Provision for Income Taxes: --------------------------- The tax provision for the quarter ended June 30, 1995 varies from the U.S. statutory tax rate because of the provision for state income taxes, losses of subsidiaries which generate no current tax benefit, tax credits and taxes on foreign earnings. The effective tax rate was 38% for the three and six months ended June 30, 1995 as compared to 37% and 36%, respectively, for the corresponding periods in 1994. The increase was due primarily to the expiration of the Orphan Drug Credit effective December 31, 1994. The allocated tax benefit of $2.0 million generated by GTR reduced the General -17- 18 Division's tax rate to 26% and 27%, respectively, for the quarter and six months ended June 30, 1995. 6. Additional Investments in Unconsolidated Affiliate: --------------------------------------------------- In June 1995, the General Division converted approximately $4.0 million of Genzyme Transgenics Corporation ("GTC") debt into equity through the acquisition of 1.3 million shares of GTC common stock. The transaction increased the General Division's interest in GTC to 49%. On July 3, 1995, GTC acquired Biodevelopment Laboratories, Inc. ("BDL"). As part of the transaction, the General Division issued approximately 34,000 shares of General Division Common Stock to former stockholders of BDL in exchange for approximately 475,000 shares of newly issued GTC stock. In total, GTC issued approximately 1,207,000 shares in the transaction, resulting in a decrease in the Division's interest in GTC to 48.2%. Also as part of the BDL transaction, the Company guaranteed a $7,500,000 line of credit to GTC from a commercial bank in return for warrants to purchase 145,000 shares of GTC stock. -18- 19 GENZYME GENERAL DIVISION MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 1995 The following discussion is a summary of the key factors management considers necessary in reviewing the General Division's results of operations, liquidity and capital resources. This discussion should be read in conjunction with the financial statements and related notes of Genzyme. RESULTS OF OPERATIONS Revenue ------- Total revenues for the three and six months ended June 30, 1995 were $92.4 million and $179.5 million, respectively, compared to $75.4 million and $148.7 million, respectively, for the corresponding periods in 1994. Product and service revenues were $85.9 million and $166.6 million, respectively, an increase of 22% and 21%, respectively, over the same periods in 1994. Product revenues increased 29% to $74.1 million for the second quarter, and 28% to $142.3 million for the six months ended June 30, 1995, reflecting sales increases in the Therapeutics, Diagnostic Products and Pharmaceuticals businesses of 26%, 26% and 78%, respectively, for the second quarter and 28%, 20% and 53%, respectively, for the six months ended June 30, 1995. The increase in sales of Therapeutic products resulted primarily from increased shipments of Ceredase[R] enzyme, for which the rate of new patient accruals more than offset dosage reductions, and the market introduction, in the second quarter of 1994, of Cerezyme[TM] enzyme, the recombinant form of Ceredase[R] enzyme. The increase in Diagnostic Product sales resulted from sales increases across most product lines including a doubling in revenues from sales of Direct LDL tests. The increase in Pharmaceutical sales resulted from the operations of a Swiss company acquired in July 1994. Diagnostic Service revenues for the second quarter and six months ended June 30, 1995 declined 10% to $11.8 million and $24.3 million, respectively, resulting primarily from the divestiture of two small genetic diagnostic laboratories and a decline in identity testing revenues. International sales represented approximately 41% and 42%, respectively, of product sales for the second quarter and six months ended June 30, 1995 compared with approximately 34% for the second quarter and six months ended June 30, 1994. The increase was due primarily to increases of 56% and 62%, respectively, for the quarter and six months ended June 30, 1995 in the combined international sales of Ceredase[R]/Cerezyme[TM] enzyme as well as favorable exchange rates. Revenues from research and development contracts for the three and six months ended June 30, 1995 were $6.5 million and $12.9 million, respectively, an increase of 36% and 21%, respectively, from the corresponding periods in 1994. Revenues from Neozyme II increased 49% to $6.0 million for the second quarter of 1995 due primarily to increased activity relating to collaborations with third parties. For the six months ended June 30, 1995, revenues from Neozyme II increased 40% to $11.7 million. In the first quarter of 1994, the Surgical Aids Partnership provided revenues to the General Division of $0.9 million thereby exhausting the funds it had available for the funding of the HAL[TM] products. In the first six months of 1994, consolidation of the operations of Genzyme Transgenics Corporation ("GTC") provided $1.3 million of reported revenues from research and development contracts. Beginning in the fourth quarter of 1994, the Division accounts for GTC using the equity method of accounting and, accordingly, no longer reports GTC's revenue from research and development contracts. -19- 20 Margins and Operating Expenses ------------------------------ Total gross margin for the three and six months ended June 30, 1995 was 56% and 57%, respectively, compared to 57% and 58%, respectively, for the corresponding periods in 1994. The General Division provides a broad range of health care products and services, resulting in a range of gross margins depending on the particular market conditions of each product or service. Product margins for the three and six months ended June 30, 1995 declined to 60% and 61%, respectively, from 61% and 63%, respectively, for the same periods in 1994 due primarily to a provision for obsolete Fine Chemicals inventory as the Company concentrates upon the Pharmaceuticals business. Diagnostic Service margins for the three and six months ended June 30, 1995 decreased to 34% and 35%, respectively, from 36% and 37%, respectively, due to high fixed costs associated with identity testing which experienced a decline in revenues relative to the same periods in 1994. Selling, general and administrative expenses for the three and six months ended June 30, 1995 were $23.4 million and $47.6 million, respectively, compared to $20.2 million and $42.5 million, respectively, for the same periods in 1994. The increase was due primarily to increased staffing in support of the growth in several product lines and to the ongoing expenses associated with operations acquired or established in 1994. As a percentage of total revenues, selling, general and administrative expenses for the six months ended June 30, 1995 were 25% and 27%, respectively, compared to 27% and 29%, respectively, for the corresponding periods in 1994. Research and development expenses for the three and six months ended June 30, 1995 were $14.1 million and $27.8 million, respectively, compared to $12.2 million and $24.5 million, respectively, for the same periods in 1994 due to increased efforts on behalf of Neozyme II and increased spending on internal programs. Other Income and Expenses ------------------------- Investment income for the quarter and six months ended June 30, 1995 totaled $1.0 million and $2.5 million, respectively, compared with $2.0 million and $5.8 million, respectively, for the same periods in 1994. Investment income for the three and six months ended June 30, 1995 includes losses on the sales of securities of $25,000 and $110,000, respectively, as compared to losses of $18,000 and gains of $1.6 million, respectively, on the sales of securities for the corresponding periods in 1994. Excluding the effect of these realized gains and losses, investment income for the six months ended June 30, 1995 decreased 38% due to lower average cash and investment balances. Interest expense for the quarter and six months ended June 30, 1995 was $173,000 and $220,000, respectively, net of capitalized interest on construction in progress of $2.3 million and $4.8 million, respectively. Interest relating to Genzyme's 6 3/4% convertible subordinated notes was $1.7 million and $3.4 million, respectively, equal to the amount incurred in the same periods in 1994. The General Division also incurred interest expense for the three and six months ended June 30, 1995 of $0.4 million and $0.8 million, respectively, related to a $21.5 million mortgage note issued in the second quarter of 1994, $0.1 million and $0.2 million, respectively, related to a deferred liability established to acquire the remaining shares of a Swiss company acquired, in part, in July 1994 and the remainder related to interest on capitalized leases. The tax provision for the quarter and six months ended June 30, 1995 varies from the U.S. statutory tax rate because of the provision for state income taxes, losses of subsidiaries which generate no current tax benefit, tax credits and taxes on foreign earnings. The effective tax rate was 38% for the three and six months ended June 30, 1995 as compared to 37% and 36%, respectively, for the corresponding periods in 1994. The increase was due primarily to the expiration of the Orphan Drug Credit effective December 31, 1994. The allocated tax benefit of $2.0 million generated by GTR reduced the General Division's tax rate to 26% and 27%, respectively, for the quarter and six months ended June 30, 1995. -20- 21 LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1995, the General Division had cash, cash equivalents and investments in marketable securities totaling $86.4 million, a decrease of $42.3 million from December 31, 1994. The General Division repaid a $39.0 million term loan in January 1995. In the six months ended June 30, 1995, the General Division spent $25.5 million on increased manufacturing capacity and invested an additional $4.0 million in GTC, an unconsolidated affiliate. These expenditures were financed primarily by operations, $18.9 million, and by the issuance of common stock through exercises of stock options and warrants, $6.7 million. As of June 30, 1995, the General Division had accounts receivable of $80.2 million, an increase of $3.6 million from December 31, 1994, due primarily to increased sales. Inventories increased $5.1 million, or 14%, to $41.9 million as of June 30, 1995 as compared to December 31, 1994. The increase was due primarily to improved Ceredase[R] yields and management's efforts to build Ceredase[R] inventories, support of increased business operations and, in part, to exchange rate fluctuations. In January 1995, the General Division renewed its commitment to continue funding, until March 1, 1996, the development of the HAL[TM] products on behalf of the Surgical Aids Partnership whose available funds were fully expended in the first quarter of 1994. -21- 22 GENZYME TISSUE REPAIR DIVISION CONDENSED COMBINED STATEMENTS OF OPERATIONS (UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) JUNE 30, JUNE 30, ------------------------------------------------------------------------------------------------- 1995 1994 1995 1994 ---- ---- ---- ---- Revenues: Net product sales.............................. $ 1,247 $ - $ 2,277 $ - Operating costs and expenses: Cost of products sold.......................... 880 - 1,605 - Selling, general and administrative............ 2,541 226 4,293 389 Research and development....................... 3,115 903 5,929 1,555 ------- ------- ------- ------- 6,536 1,129 11,827 1,944 ------- ------- ------- ------- Operating loss.................................. (5,289) (1,129) (9,550) (1,944) Investment income............................... 262 - 581 - ------- ------- ------- ------- Net loss........................................ $(5,027) $(1,129) $(8,969) $(1,944) ======= ======= ======= ======= Per Tissue Repair Division Common share: Net loss....................................... $ (0.57) $ (0.34) $ (1.03) $ (0.59) ======= ======= ======= ======= Average shares outstanding..................... 8,763 3,292 8,721 3,287 ======= ======= ======= =======
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -22- 23 GENZYME TISSUE REPAIR DIVISION COMBINED BALANCE SHEETS (UNAUDITED)
(DOLLARS IN THOUSANDS) JUNE 30, DECEMBER 31, ----------------------------------------------------------------------------------------- 1995 1994 ---- ---- ASSETS Current Assets: Cash and cash equivalents............................... $ 5,262 $16,993 Short-term investments.................................. 9,004 5,918 Accounts receivable, less allowance for doubtful accounts.................................. 995 1,486 Inventories............................................. 110 76 Prepaid expenses and other current assets............... 188 284 ------- ------- Total current assets.................................. 15,559 24,757 Property, plant and equipment, net....................... 1,302 1,456 Other Assets: Long-term investments................................... 1,974 1,897 Other noncurrent assets................................. 317 325 ------- ------- 2,291 2,222 ------- ------- $19,152 $28,435 ======= ======= LIABILITIES AND DIVISION EQUITY Current Liabilities: Accounts payable........................................ $ 776 $ 528 Accrued expenses........................................ 1,584 3,220 Payable to Genzyme General Division..................... 826 171 Current portion of capital lease obligations............ 297 281 ------- ------- Total current liabilities............................. 3,483 4,200 Noncurrent Liabilities: Capital lease obligations............................... 19 174 Other noncurrent liabilities............................ 728 748 ------- ------- 747 922 Division equity.......................................... 14,922 23,313 ------- ------- $19,152 $28,435 ======= =======
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -23- 24 GENZYME TISSUE REPAIR DIVISION CONDENSED COMBINED STATEMENTS OF CASH FLOWS (UNAUDITED)
(DOLLARS IN THOUSANDS) SIX MONTHS ENDED JUNE 30, ---------------------------------------------------------------------------- 1995 1994 ---- ---- OPERATING ACTIVITIES: Net loss.............................................. $ (8,969) $(1,944) Reconciliation of net loss to net cash from operating activities: Depreciation and amortization....................... 313 - Accrued interest/amortization on bonds.............. (99) - Increase (decrease) in cash from working capital: Accounts receivable............................... 491 - Inventories....................................... (34) - Prepaid expenses and other current assets......... 96 - Accounts payable, accrued expenses and deferred revenue............................. (1,388) - Due to Genzyme General Division................... 655 - -------- ------- Net cash from operating activities................ (8,935) (1,944) INVESTING ACTIVITIES: Purchases of investments.............................. (10,957) - Sales and maturities of investments................... 8,087 - Property, plant and equipment......................... (159) - Other noncurrent assets............................... 8 - -------- ------- Net cash from investing activities................ (3,021) - FINANCING ACTIVITIES: Issuance of TR Stock.................................. 385 - Payments of capital lease obligations................. (139) - Net cash from Genzyme................................. - 1,944 Other................................................. (21) - -------- ------- Net cash from financing activities................ 225 1,944 -------- ------- Decrease in cash and cash equivalents ................. (11,731) - Cash and cash equivalents, beginning of period......... 16,993 - -------- ------- Cash and cash equivalents, end of period............... $ 5,262 $ - ======== ======= Supplemental Cash Flow Information: Cash paid during the period for interest.............. $ 24 $ -
The accompanying notes are an integral part of these unaudited, condensed, combined financial statements. -24- 25 GENZYME TISSUE REPAIR DIVISION NOTES TO UNAUDITED CONDENSED COMBINED FINANCIAL STATEMENTS 1. Basis of Presentation: ---------------------- These unaudited, condensed, combined financial statements should be read in conjunction with the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1994 and the financial statements and footnotes for Genzyme Tissue Repair Division ("GTR") included therein. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. Certain items in the 1994 financial statements have been reclassified to conform with the 1995 presentation. The financial statements for the three and six months ended June 30, 1995 and 1994 are unaudited but include, in GTR's opinion, all adjustments (consisting only of normally recurring accruals) necessary for a fair presentation of the results for the periods presented. 2. Accounting Policies: -------------------- The accounting policies underlying the quarterly financial statements are those set forth in Note A of GTR's financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 1994. 3. Investments: ------------ As of June 30, 1995, GTR's investment portfolio, consisting primarily of debt securities classified as available for sale, was adjusted to its market value. As a result, gross unrealized holding losses totaling approximately $62,000 were recorded in a separate component of Division equity. 4. Inventories: ------------
June 30, 1995 December 31, 1994 ------------- ----------------- Raw Materials.............. $ 79,000 $55,000 Work-in-process............ 31,000 21,000 -------- ------- $110,000 $76,000
======== ======= -25- 26 GENZYME TISSUE REPAIR DIVISION MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 1995 The following discussion is a summary of the key factors management considers necessary in reviewing GTR's results of operations, liquidity and capital resources. This discussion should be read in conjunction with the financial statements and related notes of Genzyme. RESULTS OF OPERATIONS Revenue ------- Product revenues for the three and six months ended June 30, 1995 were $1,247,000 and $2,277,000, respectively. Product revenues related solely to the operations of BioSurface Technology, Inc., ("BioSurface") acquired in the fourth quarter of 1994. Revenues consisted primarily of sales of EpicelSM skin grafts which are dependent upon numerous factors, many of which are not in GTR's control. As a result, GTR expects sales of EpicelSM skin grafts to fluctuate from period to period. Revenues also included $30,000 and $40,000, respectively, for the three and six months ended June 30, 1995 from the sales of CarticelSM Service, GTR's cartilage repair service, which commenced in the first quarter of 1995. Margins and Operating Expenses ------------------------------ Gross margins for the quarter and six months ended June 30, 1995 were 29% and 30%, respectively. GTR incurs direct selling, general and administrative expenses as well as a selling, general and administrative charge, based on actual amounts incurred, from the General Division for selling, general and administrative work performed by the General Division on behalf of GTR. Selling, general and administrative expenses for the three and six months ended June 30, 1995 were $2,541,000 and $4,293,000, respectively, compared to $226,000 and $389,000, respectively, for the corresponding periods in 1994. The increase was due to increased support of GTR research and development by the General Division and to the acquisition of BioSurface. GTR incurs direct research and development expenses as well as a charge for research and development work performed by the General Division on behalf of GTR. Research and development expenses for the quarter and six months ended June 30, 1995 were $3,115,000 and $5,929,000, respectively, compared to $903,000 and $1,555,000, respectively, for the corresponding periods in 1994. Research and development expenses related to the operations of BioSurface were $1,732,000 and $3,490,000, respectively, for the quarter and six months ended June 30, 1995. Excluding the effect of BioSurface, research and development expenses increased 53% and 57%, respectively, for the quarter and six months ended June 30, 1995 due primarily to increased outside clinical trials and manufacturing support related to the Vianain[R] programs. LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1995, GTR had approximately $16.2 million of cash, cash equivalents and investments in marketable securities, a decrease of $8.6 million from December 31, 1994. The decrease was due to GTR's net loss and an increase in working capital requirements which were funded by additional amounts payable to the General Division and proceeds from the issuance of stock pursuant to stock option and stock purchase plans. -26- 27 GTR anticipates that available funds plus revenues generated from the CarticelSM Service and from sales of EpicelSM skin grafts will be sufficient to fund GTR's operations through the end of 1995. In addition, Genzyme is required to allocate up to $30 million in cash from the General Division during specified periods through June 1998, unless additional funds are raised from the sale of Tissue Repair Division Common Stock to outside investors or unless the cash balance of the General Division falls below $60 million. If the cash balance of the General Division is between $60 million and $90 million, the Funding Commitment will be reduced on a pro rata basis. The General Division's cash balance at June 30, 1995 was $86.4 million. Significant additional funds will be required to complete commercialization and clinical testing of GTR's products. -27- 28 GENZYME CORPORATION AND SUBSIDIARIES FORM 10-Q/A, JUNE 30, 1995 SIGNATURES ---------- Pursuant to the requirements of the Securities and 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 DATE: September 13, 1995 By: /s/David J. McLachlan ----------------------------- David J. McLachlan Duly Authorized Officer and Chief Financial Officer -28-