1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10 - Q X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For quarter ended December 31, 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: 0-10961 QUIDEL CORPORATION (Exact name of Registrant as specified in its charter) DELAWARE 94-2573850 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 10165 McKellar Court, San Diego, California 92121 (Address of principal executive offices) Registrant's telephone number, including area code (619) 552-1100 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 the Registrant's Common Stock as of December 31, 1995 was 21,363,047. 2 QUIDEL CORPORATION TABLE OF CONTENTS Page Numbers ------- PART I - FINANCIAL INFORMATION ITEM 1. Financial Statements Condensed Consolidated Balance Sheets December 31, 1995 and March 31, 1995 . . . . . . . . . . . . . . . . . . . . . 3 Condensed Consolidated Statements of Operations Three months ended December 31, 1995 and 1994 . . . . . . . . . . . . . . . . . 4 Condensed Consolidated Statements of Operations Nine months ended December 31, 1995 and 1994 . . . . . . . . . . . . . . . . . 5 Condensed Consolidated Statements of Cash Flows Nine months ended December 31, 1995 and 1994 . . . . . . . . . . . . . . . . . 6 Notes to Unaudited Condensed Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations . . . . . . . . . . . . . . . . . . . . 7 - 9 PART II - OTHER INFORMATION ITEM 1. Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 ITEM 2. Changes in Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 ITEM 3. Defaults upon Senior Securities . . . . . . . . . . . . . . . . . . . . . . . . 9 ITEM 4. Submission of Matters to a Vote of Security Holders . . . . . . . . . . . . . . 9 ITEM 5. Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 ITEM 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . . . . . . . . . . . . 9 Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2 3 QUIDEL CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS December 31, March 31, ASSETS 1995 1995 ------ ------------ --------- (Unaudited) Current assets: Cash and cash equivalents $ 2,775,000 $ 3,878,000 Accounts receivable, including $31,000 due from related parties ($257,000 as of March 31, 1995) 7,139,000 6,822,000 Inventories, at lower of cost (first-in, first-out) or market: Raw materials 2,094,000 2,570,000 Work in process 1,093,000 1,158,000 Finished goods 1,022,000 1,137,000 ------------- --------------- 4,209,000 4,865,000 Prepaid expenses and other current assets 379,000 633,000 ------------- --------------- Total current assets 14,502,000 16,198,000 Property and equipment, net 13,603,000 12,521,000 Intangible assets, net 5,188,000 5,409,000 Other assets 234,000 396,000 ------------- --------------- $ 33,527,000 $ 34,524,000 ============= =============== LIABILITIES AND STOCKHOLDERS' EQUITY ------------------------------------ Current liabilities: Accounts payable $ 1,525,000 $ 2,176,000 Accrued payroll and related expenses 878,000 880,000 Note payable to bank under line of credit 564,000 674,000 Accrued acquisition costs 44,000 685,000 Current portion of long-term debt and obligations under capital leases 589,000 357,000 Other current liabilities 917,000 1,669,000 ------------- --------------- Total current liabilities 4,517,000 6,441,000 Long-term debt and obligations under capital leases 3,683,000 4,145,000 Stockholders' equity: Common stock 21,000 21,000 Additional paid-in capital 109,797,000 108,854,000 Accumulated deficit (84,491,000) (84,937,000) ------------- --------------- Total stockholders' equity 25,327,000 23,938,000 ------------- --------------- $ 33,527,000 $ 34,524,000 ============= =============== See accompanying notes. 3 4 QUIDEL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three months ended December 31, 1995 1994 ---- ---- Revenues: Net sales, including $31,000 and $1,046,000 from a related party for the three months ended December 31, 1995 and 1994, respectively $ 9,044,000 $ 9,201,000 Contracts, license fees and distribution agreements 209,000 36,000 ------------- --------------- Total revenues 9,253,000 9,237,000 Costs and expenses: Cost of sales 4,248,000 4,220,000 Research and development 1,014,000 901,000 Sales and marketing 2,612,000 2,557,000 General and administrative 866,000 727,000 ------------- --------------- Total costs and expenses 8,740,000 8,405,000 Operating income 513,000 832,000 Other income and expense: Interest income 39,000 53,000 Interest expense (130,000) (211,000) ------------- --------------- Net income $ 422,000 $ 674,000 ============= =============== Net income per share $ .02 $ .04 ============= =============== Shares used in computing net income per share 23,056,000 18,994,000 ============= =============== See accompanying notes. 4 5 QUIDEL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Nine months ended December 31, 1995 1994 ---- ---- Revenues: Net sales, including $356,000 and $1,838,000 from a related party for the nine months ended December 31, 1995 and 1994, respectively $ 25,654,000 $ 21,255,000 Contracts, license fees and distribution agreements 479,000 467,000 ------------- --------------- Total revenues 26,133,000 21,722,000 Costs and expenses: Cost of sales 11,883,000 10,902,000 Research and development 2,991,000 2,565,000 Sales and marketing 7,994,000 7,456,000 General and administrative 2,542,000 2,067,000 ------------- --------------- Total costs and expenses 25,410,000 22,990,000 Operating income (loss) 723,000 (1,268,000) Other income and expense: Interest income 129,000 145,000 Interest expense (406,000) (592,000) ------------- --------------- Net income (loss) $ 446,000 $ (1,715,000) ============= =============== Net income (loss) per share $ .02 $ (.09) ============= =============== Shares used in computing net income (loss) per share 22,550,000 18,578,000 ============= =============== See accompanying notes. 5 6 QUIDEL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Nine months ended December 31, 1995 1994 ---- ---- Cash flows from operating activities: Net income (loss) $ 446,000 $ (1,715,000) Adjustments to reconcile net income (loss) to net cash flows provided by (used for) operating activities: Depreciation and amortization 1,505,000 1,394,000 Provision for losses on accounts receivable -- 160,000 Changes in assets and liabilities: Accounts receivable (317,000) 1,044,000 Inventories 656,000 280,000 Prepaid expenses and other current assets 254,000 185,000 Accounts payable (651,000) (346,000) Accrued payroll and related expenses (2,000) (170,000) Accrued acquisition expenses (591,000) -- Other current liabilities (752,000) 113,000 ------------- --------------- Net cash flows from operating activities 548,000 945,000 Cash flows used for investing activities: Additions to equipment and improvements (2,119,000) (1,122,000) Increase in other assets (135,000) (827,000) ------------- --------------- Net cash flows used for investing activities (2,254,000) (1,949,000) Cash flows provided by (used for) financing activities: Net proceeds from issuance of common stock 943,000 227,000 Payments on line of credit (110,000) (1,343,000) Payments on notes payable, long-term debt and obligations under capital leases (230,000) (3,585,000) Proceeds from issuance of debt -- 3,875,000 ------------- --------------- Net cash flows provided by (used for) financing activities 603,000 (826,000) Net decrease in cash and cash equivalents (1,103,000) (1,830,000) Cash and cash equivalents at beginning of period 3,878,000 3,173,000 ------------- --------------- Cash and cash equivalents at end of period $ 2,775,000 $ 1,343,000 ============= =============== Supplemental disclosures of cash flow information: Cash paid during the period for interest $ 368,000 $ 598,000 ============= =============== See accompanying notes. 6 7 QUIDEL CORPORATION NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 1. Basis of Presentation QUIDEL Corporation (the "Company") discovers, develops, manufactures and markets diagnostic products for human health care. The unaudited financial information included herein is condensed and has been prepared in accordance with generally accepted accounting principles applicable to interim periods; consequently it does not include all generally accepted accounting disclosures required for complete annual financial statements. The condensed financial information contains, in the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary to state fairly the Company's financial position, results of operations and cash flows. The Company's results of operations for the three and nine months ended December 31, 1995 are not necessarily indicative of the results to be expected for the full year. Management suggests that these condensed financial statements be read in conjunction with the financial statements and notes thereto for the year ended March 31, 1995, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. NET INCOME (LOSS) PER SHARE - Net income (loss) per share has been computed using the weighted average number of common shares and for income periods dilutive common stock equivalents outstanding during each period presented. Common shares issuable upon exercise of certain warrants and stock options or upon conversion of notes payable were not included in the calculations for loss periods since the effect of their inclusion would be antidilutive. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Results of Operations Net sales for the third quarter ended December 31, 1995 totaled $9,044,000, down $157,000 or 2% from the same period of the prior year. The mix of the Company's sales continues to shift away from U.S. OEM sales which declined $1,015,000 to $31,000 in the current quarter vs. the same period in the prior year. The year-to-year comparison of third quarter net sales was also impacted by a $778,000 reduction in U.S. sales of the Company's Strep A tests, due in part to the increased level of prior year sales resulting from the initial introduction of the new in-line one step strep test. These reductions were offset in part by $1,534,000 in sales of pregnancy and mononucleosis products of our subsidiary Pacific Biotech, Inc., a 7 8 California corporation ("PBI") acquired in January 1995 which were not present in the third quarter of the prior year. Net sales for the nine months ended December 31, 1995 totaled $25,654,000, up $4,399,000 or 21% from the prior year level. The significant changes between the current and prior year nine month periods included the addition of sales of PBI products not present in the prior year amounting to $5,016,000, increased international sales of $1,084,000 due in part to sales by the Company's European subsidiaries, some of which were not present in the first quarter of the prior year, partially offset by a reduction of $1,482,000 in U.S. OEM sales and $712,000 in sales of Strep A tests as discussed above. Gross profit for the third quarter represented 53% of sales compared to 54% in the prior year quarter. Year-to-date gross profit as a percentage of sales stands at 54%, up from the prior year's 49% of sales, due to increased sales volume in relation to a relatively constant level of manufacturing overhead costs. Overall operating expense increased $307,000 (7%) and $1,439,000 (12%) in the current quarter and nine month periods respectively, versus the prior year periods. Research and development expense has increased in line with the increased activity in new product development projects. Increases in sales and marketing expense reflects the addition of our new European subsidiaries in Germany and Spain which were not present in the first quarter of the prior year. General and administrative expense in the current quarter and year-to-date period has increased over the prior year, due principally to increased personnel cost, bad debt expense and legal fees. Net income of $422,000 for the quarter ended December 31, 1995, although $252,000 below that of the prior year period, marks the third consecutive profitable quarter this year. The year-to-date improvement in sales and gross profit has resulted in current year-to-date net income of $446,000 as contrasted to a net loss of $1,715,000 in the prior year nine month period. The Company's operating results may continue to fluctuate on a quarter to quarter basis as a result of a number of factors, including the phase-out of older products near the end of their product life cycles, the timing and success of new product introductions, relationships with strategic marketing partners and seasonality, e.g. the higher incidence of strep throat in the fall and winter months. Actual results for the remainder of the fiscal year will be influenced by competitive and economic factors affecting the Company's markets, actions of our major distributors, and the degree of acceptance that our new products achieve during the year. 8 9 Liquidity and Capital Resources At December 31, 1995, the Company had cash and cash equivalents of $2,775,000, compared to $3,878,000 at March 31, 1995. Cash provided by operations totaled $548,000 for the nine month period ended December 31, 1995, reflecting in part profitable operations and proceeds from a reduction in inventory offset by increased accounts receivable, payments of accounts payable and PBI acquisition-related expenses. The principal use of cash in the nine months ended December 31, 1995 was related to the $2,119,000 invested in capital programs for new production equipment and facility improvements required because of increased volume. During the balance of fiscal 1996, the Company's principal capital requirements will be related to the capital expenditures associated with automated production systems which are intended to increase quality and capacity and to reduce product cost, and for other working capital needs. The Company's working capital requirements fluctuate as a result of numerous factors, such as the extent to which the Company uses or generates cash in operations, progress in research and development projects and the time and expenditures required to obtain governmental approval of its products. The Company has established an accounts receivable based bank line of credit which provides for borrowing up to $3 million. At December 31, 1995 there were no outstanding borrowings under the line of credit. Based on its current cash position and its current assessment of future operating results, management believes that its existing sources of liquidity should be adequate to meet its operating needs. PART II - OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS None ITEM 2. CHANGES IN SECURITIES None ITEM 3. DEFAULTS UPON SENIOR SECURITIES None ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None ITEM 5. OTHER INFORMATION None ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits Exhibit Number Exhibit ------- ------- 27 Financial Data Schedule (b) Reports on Form 8-K None 9 10 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. QUIDEL CORPORATION ------------------------- (Registrant) Date: February 14 , 1996 /S/ STEVEN C. BURKE ------------------------- Steven C. Burke Chief Accounting Officer Signed both as a duly authorized officer to sign on behalf of the Registrant and as Chief Accounting Officer 10