-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PXSREUOo4XxcYeWfOg9KUrS+UkAYklOPvL4clQAX4MEGtEoIVasdUBUgnrrM8BAy m6WWodH9UL4e6nRjX2XchQ== 0000873591-98-000063.txt : 19981116 0000873591-98-000063.hdr.sgml : 19981116 ACCESSION NUMBER: 0000873591-98-000063 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19980930 FILED AS OF DATE: 19981113 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDIMMUNE INC /DE CENTRAL INDEX KEY: 0000873591 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 521555759 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: SEC FILE NUMBER: 000-19131 FILM NUMBER: 98747520 BUSINESS ADDRESS: STREET 1: 35 W WATKINS MILL RD CITY: GAITHERSBURG STATE: MD ZIP: 20878 BUSINESS PHONE: 3014170770 MAIL ADDRESS: STREET 1: 35 W WATKINS MILL ROAD CITY: GAITHERSBURG STATE: MD ZIP: 20878 10-Q 1 3RD QUARTER FILING 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 the quarterly period ended September 30, 1998 Commission File No. 0-19131 MEDIMMUNE, INC. (Exact name of registrant as specified in its charter) Delaware 52-1555759 (State or other jurisdiction of (I. R. S. Employer incorporation or organization) Identification No.) 35 West Watkins Mill Road, Gaithersburg, MD 20878 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (301)417-0770 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 [ ] As of September 30, 1998, 26,719,304 shares of Common Stock, par value $0.01 per share, were outstanding. MEDIMMUNE, INC. Index to Form 10-Q Part I Financial Page Item 1. Financial Statements Balance Sheets 1 Statements of Operations 2 Condensed Statements of Cash Flows 3 Notes to Financial Statements 4-7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 8-12 Part II Other Information 13-14 Item 1. Legal Proceedings Item 2. Changes in Securities Item 3. Defaults upon Senior Securities Item 4. Submission of Matters to a Vote of Security Holders Item 5. Other Information Item 6. Exhibits and Reports on Form 8-K CytoGam and RespiGam are registered trademarks of the Company and Synagis is a trademark.
ITEM 1. FINANCIAL STATEMENTS MEDIMMUNE, INC. BALANCE SHEETS (in thousands, except share data) September 30, December 31, 1998 1997 ---------- ---------- ASSETS: (Unaudited) Cash and cash equivalents $ 22,422 $ 29,984 Marketable securities 77,928 20,342 Trade receivables, net 13,199 15,236 Contract receivables, net 2,989 3,064 Inventory, net 24,136 28,857 Other current assets 3,371 2,740 ---------- ---------- Total Current Assets 144,045 100,223 Property and equipment, net 69,020 65,254 Inventory-noncurrent 4,434 2,446 Other assets 2,157 2,413 ---------- ---------- Total Assets $219,656 $170,336 ========== ========== LIABILITIES AND SHAREHOLDERS' EQUITY: Accounts payable $ 2,580 $ 4,535 Accrued expenses 23,596 27,682 Product royalties payable 3,651 6,227 Accrued interest 1,536 2,583 Other current liabilities 2,997 2,633 --------- ---------- Total Current Liabilities 34,360 43,660 Long term debt 83,878 85,363 Other liabilities 1,162 777 ---------- ---------- Total Liabilities 119,400 129,800 ---------- ---------- Commitments and Contingencies SHAREHOLDERS' EQUITY: Preferred stock, $.01 par value; authorized 5,524,525 shares; none issued or outstanding -- -- Common stock, $.01 par value; authorized 120,000,000 shares; issued and outstanding 26,719,304 at September 30, 1998 and 24,444,745 at December 31, 1997 267 244 Paid-in capital 252,676 176,564 Accumulated deficit (152,687) (136,272) ---------- ---------- Total Shareholders' Equity 100,256 40,536 ---------- ---------- Total Liabilities and Shareholders' Equity $219,656 $170,336 ========== ==========
The accompanying notes are an integral part of these financial statements. 1
MEDIMMUNE, INC. STATEMENTS OF OPERATIONS (Unaudited) (in thousands except per share data) For the For the three months ended nine months ended September 30, September 30, ----------------- ----------------- 1998 1997 1998 1997 ------- ------- ------- ------- Revenues: Product sales $ 22,181 $ 10,575 $ 73,224 $ 26,931 Other 1,659 84 34,545 277 -------- -------- -------- -------- Total revenues 23,840 10,659 107,769 27,208 -------- -------- -------- -------- Costs and Expenses: Cost of sales 6,903 5,258 43,661 13,903 Research and development 5,766 9,342 18,761 33,283 Selling, administrative and general 14,286 6,603 30,430 17,371 Other operating expenses 8,509 3,094 33,447 3,718 -------- -------- -------- -------- Total expenses 35,464 24,297 126,299 68,275 -------- -------- -------- -------- Operating Loss (11,624) (13,638) (18,530) (41,067) Interest income 1,615 767 5,176 3,486 Interest expense (1,043) (786) (3,061) (2,607) -------- -------- -------- -------- Net Loss ($11,052) ($13,657) ($16,415) ($40,188) ======== ======== ======== ======== Loss Per Common Share basic and diluted ($0.41) ($0.57) ($0.62) ($1.77) ======== ======== ======== ======== Shares Used in Computing Loss per common share, basic and diluted 26,655 23,938 26,377 22,718 ======== ======== ======== ========
The accompanying notes are an integral part of these financial statements. 2
MEDIMMUNE, INC. CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) (in thousands) For the nine months ended September 30, 1998 1997 -------- -------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss ($16,415) ($40,188) Noncash items: Depreciation and amortization 2,131 1,774 Amortization of premium on marketable securities 995 689 Increase in reserve for inventory 10,803 -- Other (1,876) (1,154) Other changes in assets and liabilities (16,073) (22,019) -------- -------- Net cash used in operating activities (20,435) (60,898) -------- -------- CASH FLOWS FROM INVESTING ACTIVITIES: (Increase) decrease in marketable (58,581) 74,174 securities Capital expenditures (3,703) ( 31,939) -------- -------- Net cash (used in)provided by investing activities (62,284) 42,235 -------- -------- CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of common stock and exercise of stock options 76,135 3,379 (Decrease) increase in long term debt (978) 6,170 -------- -------- Net cash provided by financing 75,157 9,549 activities -------- -------- Net decrease in cash and cash equivalents (7,562) (9,114) Cash and cash equivalents at beginning of period 29,984 12,629 -------- -------- Cash and cash equivalents at end of period $22,422 $3,515 ======== ========
The accompanying notes are an integral part of these financial statements. 3 MEDIMMUNE, INC. CONDENSED NOTES TO FINANCIAL STATEMENTS (UNAUDITED) General The financial information presented as of September 30, 1998, and for the periods ended September 30, 1998 and 1997, is unaudited. In the opinion of the Company's management, the financial information contains all adjustments (which consist only of normal recurring adjustments) necessary for a fair presentation of such financial information. Inventory Inventory net of reserves, consists of the following (in thousands):
September 30, December 31, 1998 1997 ------------- ------------- Raw Materials $ 9,944 $14,503 Work in Process 13,352 12,990 Finished Goods 5,274 3,810 ------ ------ 28,570 31,303 Less noncurrent inventory (4,434) (2,446) ------ ------ $24,136 $28,857 ====== ======
The Company has purchased plasma and other raw materials for use in production in the Company's Frederick manufacturing facility, which is subject to FDA licensure and approval. Due to the uncertainty surrounding the likelihood and timing of FDA approval, this inventory has been classified as noncurrent in the accompanying balance sheet. As a result of the June 1998 FDA approval of the Company's second generation RSV product, Synagis, and the expected market acceptance of Synagis, the Company reserved approximately $9.2 million against its RespiGam inventory in the second quarter of 1998, as no further product sales are expected to result from this inventory in the foreseeable future. The remaining RespiGam plasma inventory of $3.6 million has been written down to the value the Company expects to recover upon sale to third parties. Should the Company be unable to sell the plasma at its net book value, a further adjustment in a subsequent quarter may be necessary. Finished goods at September 30, 1998 and December 31, 1997 include approximately $1.6 million and $0.8 million, respectively, of by-products 4 that result from the production of the Company's principal products at one of its contract manufacturers and are held for resale. As of September 30, 1998, minimal sales of these by-products have occurred. The September 30, 1998 balance is net of a reserve of $1.6 million. Property and Equipment Property and equipment, stated at cost, consists of the following (in thousands):
September 30, December 31, 1998 1997 ---------- ----------- Land $ 1,521 $ 1,521 Building and building improvements 4,179 -- Leasehold improvements 11,866 11,042 Laboratory equipment 10,688 9,355 Office furniture, computers, and 5,715 4,377 equipment Construction in progress 47,261 49,040 -------- -------- 81,230 75,335 Less accumulated depreciation and (12,210) (10,081) amortization -------- -------- $69,020 $65,254 ======== ========
Property and equipment at September 30, 1998 and December 31, 1997 includes $4.5 million and $2.4 million, respectively, of capitalized interest related to the design and construction of the Company's manufacturing facility in Frederick, Maryland. Construction of the manufacturing facility is substantially complete and validation activities are ongoing. The Company will continue to capitalize costs, primarily capitalized interest, related to the facility for at least the next 12 months. The portions of the facility that are subject to inspection and approval by the FDA will be placed in service and depreciation will commence upon receipt of such approval. Earnings per Share The Company computes earnings (loss) per share in accordance with Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings Per Share." Basic earnings (loss) per share is computed based on the weighted average number of common shares outstanding during the period. Diluted earnings 5 (loss) per share is computed based on the weighted average shares outstanding and the dilutive common stock equivalents outstanding during the period. The dilutive effect of convertible debt is measured using the "if converted" method. The dilutive effect of stock options is measured using the treasury stock method. Common stock equivalents are not included in periods where there is a loss as they are anti-dilutive. No reconciliation of the numerators and denominators is provided, as the Company reported a loss for the periods and the inclusion of common stock equivalents would be anti-dilutive. Income Taxes No provision for income taxes has been recorded for the nine months ended September 30, 1998 because of the loss for the nine months and the existence of net operating loss carry forwards and tax credit carry forwards of $159 million. The Company's deferred tax asset has been reduced by a full valuation allowance due to uncertainty of its realization. Reversal of the allowance will occur if and when it is determined to be more likely than not that the Company will be able to realize all or a portion of the tax benefits of its carry forwards. In future quarters, the Company will review the impact, if any, that the introduction of Synagis will have on the need for a full valuation allowance. Should all such deferred tax assets be recognized, the Company expects that its effective tax rate in future periods will approximate the applicable statutory rates. New Accounting Pronouncements Comprehensive Income Effective January 1, 1998, the Company adopted SFAS No. 130, "Reporting Comprehensive Income." SFAS No. 130 requires additional reporting with respect to certain changes in assets and liabilities that previously were included in shareholders' equity. The Company has no comprehensive income items to report for the current presentation. Segment Reporting SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information," requires financial and descriptive information with respect to operating segments of an entity based on the way management disaggregates the entity for making internal operating decisions. The Company will begin making the required disclosures with financial statements for the period ending December 31, 1998. Derivative Instruments and Hedging Activities In June 1998, the FASB issued SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities". SFAS No. 133 establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts and for hedging activities. SFAS No. 133 requires companies to recognize all derivatives as either assets or liabilities, with the instruments measured at fair value. The accounting for changes in fair value, gains or losses, depends 6 on the intended use of the derivative and its resulting designation. The statement is effective for all fiscal quarters of fiscal years beginning after June 15, 1999. The Company will adopt SFAS No. 133 by January 1, 2000. Because of the Company's minimal use of derivatives, management does not anticipate that the adoption of SFAS No. 133 will have a material effect on the earnings or financial position of the Company. Subsequent Event On November 11, 1998, the Company's Board of Directors voted to declare a two-for-one stock split of the Company's common stock payable in the form of a 100 percent stock dividend. Stockholders of record as of December 15, 1998, will receive one additional share for each share of stock owned. The dividend will be distributed on December 31, 1998. 7 ITEM 2. MEDIMMUNE, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS RESULTS OF OPERATIONS THREE MONTHS ENDED SEPTEMBER 30, 1998 AND 1997 The increase in product sales to $22.2 million in third quarter 1998 from $10.6 million in third quarter 1997, is principally due to the initial sales of Synagis which commenced in September 1998, and totaled $17.0 million. Due to the seasonality of RSV disease, which principally occurs from October through April each year, these initial sales primarily represent stocking by wholesalers and distribution in advance of the season. No sales of RespiGam were recorded in third quarter 1998 versus $7.0 million in third quarter 1997, reflecting the shift in customer demand from RespiGam to Synagis for prevention of RSV disease. CytoGam sales increased 49% to $5.4 million from $3.6 million in third quarter 1997 reflecting a 35% increase in domestic units sold, a 247% increase in international units sold, as well as two price increases since July 1997. Other revenues in the 1998 third quarter of $1.7 million primarily reflect funding from SmithKline Beecham for development of a human papillomavirus vaccine. Gross margins improved to 69% in third quarter 1998 versus 50% in third quarter 1997. Gross margins in 1998 were favorably impacted by Synagis sales which carry a significantly lower per unit cost than the Company's plasma-derived products. Research, development and clinical spending decreased 38% to $5.8 million in this year's quarter from $9.3 million in last year's quarter. Expenses in 1997 included costs of concluding the Company's 1,502 patient Phase 3 Synagis clinical trial. Selling, administrative and general expenses increased to $14.3 million in this year's quarter versus $6.6 million in the 1997 quarter, an increase of 116%. Expenses in 1998 include increased marketing and selling expenses as well as co-promotion expenses to the Ross Products Division of Abbott Laboratories all in connection with the launch of Synagis which commenced during the 1998 third quarter. Marketing, selling and co-promotion expenses for Synagis are expected to continue to be higher than those for RespiGam or CytoGam. Other operating expenses of $8.5 million in the 1998 period increased from $3.1 million in the 1997 period, reflecting costs incurred for start-up at the Company's manufacturing facility in Frederick, Maryland, and costs related to scale-up of production of Synagis at a third-party manufacturer and production at the Company's Gaithersburg Manufacturing and Development Facility ("GMDF"). Expenses in the 1998 quarter also include a $1.5 million 8 milestone payment to a third-party contract manufacturer. The Company expects to continue to incur significant start-up costs for the remainder of 1998 and 1999. Interest income of $1.6 million was earned in the 1998 third quarter, compared to $0.8 million in the third quarter of 1997 reflecting higher cash balances available for investment, partially offset by a decrease in interest rates which lowered the overall portfolio yield. Interest expense of $1.0 million and $0.8 million was incurred in the 1998 and 1997 quarters, respectively, reflecting primarily interest due on the Company's convertible debt, net of capitalized interest. Interest expense in the 1998 period also includes interest on an equipment financing line that was first drawn down in third quarter 1997. The net loss in the 1998 third quarter was $11.1 million, or $0.41 basic and diluted loss per share. Shares used in computing basic and diluted loss per share were 26.7 million. The net loss for the third quarter of 1997 was $13.7 million, or $0.57 basic and diluted loss per share, on 23.9 million shares. Quarterly financial results may vary significantly due to seasonality of Synagis product sales, fluctuation in sales of CytoGam, milestones, research funding and expenditures for research, development and marketing programs. Synagis sales are expected to occur primarily during, and in proximity to, the RSV season, which typically occurs between October and April in the United States. As a result of the FDA approval of Synagis, customers may request that RespiGam vials they previously purchased be returned to the Company for refund or exchanged for Synagis vials, resulting in a possible reduction of previously recorded revenues. Currently such rights of product return do not exist and thus would be at the Company's discretion. The magnitude of such reduction, if any, cannot be determined at this time and would be impacted by factors, including but not limited to, market acceptance of Synagis and continued demand for RespiGam. NINE MONTHS ENDED SEPTEMBER 30, 1998 AND 1997 Total revenues for the nine months ended September 30, 1998 were $107.8 million compared to $27.2 million for the 1997 period, a 296% increase. Product sales of $73.2 million in the 1998 nine months increased 172% from $26.9 million in the 1997 nine months. Synagis sales commenced in September 1998 and totaled $17.0 million. CytoGam sales increased 72% from $13.9 million in the 1997 period to $23.8 in the 1998 period reflecting a 63% increase in units sold and two price increases since July 1997. In addition to growth in the core business for CytoGam, the increase in CytoGam sales includes product substitution occurring as a result of the current worldwide shortage of standard intravenous immune globulin ("IVIG") products. The duration of this shortage and continued impact, if any, on 9 CytoGam sales cannot be determined at this time. RespiGam sales in the 1998 period of $32.3 million reflect sales prior to the FDA approval of Synagis, most of which occurred in the first quarter of 1998. RespiGam sales in the 1997 nine months were $13.1 million and were limited by supply. Other revenues in the 1998 period of $34.5 million reflect research funding and milestone payments of $19.0 million from SmithKline Beecham related to the agreement signed in December 1997 for development of a human papillomavirus vaccine and a $15 million milestone payment from Abbott Laboratories received upon FDA approval of Synagis in June 1998. Cost of sales for the 1998 nine months increased 214% to $43.7 million from $13.9 million in the 1997 nine months reflecting a 131% increase in units sold and $12.1 million related to the write down of RespiGam inventory and by-product inventory. Additionally, cost of sales in 1998 includes a credit for previously recorded royalties expected to be due to MHRI. Excluding the impact of the RespiGam write down and the credit for royalty adjustments, the gross margins for the 1998 nine months improved to 53% from 48% in the 1997 period. The improved gross margins reflect the change in the product mix towards Synagis which has a lower cost per unit than CytoGam or RespiGam. Research and development expenses of $18.8 million in the 1998 nine months decreased 44% from $33.3 million in the 1997 nine months. Expenses in 1998 include a $0.5 million milestone due to a third party upon FDA approval of Synagis. Expenses in 1997 include the costs of conducting the Company's 1,502 patient Phase 3 Synagis clinical trial, with no such large scale Phase 3 trials in the 1998 period. Selling, general and administrative expenses were $30.4 million and $17.4 million for the 1998 and 1997 periods, respectively, an increase of 75%. The 1998 nine months include co-promotion expenses due to the Ross Products Division of Abbott Laboratories, the profit split with AHP for their share of the RespiGam profits, and expenses for the third quarter 1998 launch of Synagis. Expenses in 1997 are net of $2.7 million of reimbursement from AHP for its share of RespiGam product line loss as computed under the terms of the agreement. Other operating expenses in the 1998 period of $33.4 million increased from $3.7 million in the 1997 period. Expenses in 1998 include a $10.3 million charge for the buy down of certain Synagis royalty obligations prior to FDA approval, a $1.5 million milestone payment due to a third-party contract manufacturer as well as start-up costs for the Company's manufacturing facility and costs related to scale-up of production of Synagis at a third- party manufacturer and at the Company's GMDF. Interest income of $5.2 million and $3.5 million was recorded in the 1998 and 1997 nine months, respectively, a 48% increase, reflecting higher cash balances available for investment partially offset by lower interest rates which decreased the overall portfolio yield. 10 Interest expense of $3.1 million in the 1998 period versus $2.6 million in the 1997 period reflects primarily interest on the Company's convertible debt, net of capitalized interest, as well as interest on equipment financing. The net loss in the 1998 nine months was $16.4 million, or $0.62 basic and diluted loss per share versus $40.2 million in the 1997 nine months, or $1.77 basic and diluted loss per share. Shares used in computing basic and diluted loss per share in the 1998 and 1997 periods were 26.4 million and 22.7 million, respectively. LIQUIDITY AND CAPITAL RESOURCES Cash and marketable securities at September 30, 1998 were $100.4 million compared to $50.3 million at 1997 year end. Net cash used in operating activities in the nine months ended September 30, 1998 was $20.4 million, reflecting primarily a decrease in accounts payable and accrued expenses and the net loss for the nine months. Capital expenditures of $3.7 million, net of capitalized interest, for the nine months were primarily for lab equipment and facilities expansion at the Company's Gaithersburg headquarters. The Company expects inventory to grow significantly during 1998, as it purchases Synagis inventory from its third party manufacturer for the RSV season. In January 1998, the Company completed a private placement of 1.7 million shares of common stock to three institutional investors for net proceeds of $66.3 million. The Company also sold 83,410 shares of stock to SmithKline Beecham in first quarter 1998 for proceeds of $5.0 million. The Company's existing funds at September 30, 1998, together with funds expected to be generated from product sales and investment income are expected to provide sufficient liquidity to meet the anticipated needs of the business for the foreseeable future, absent the occurrence of any unforeseen events. YEAR 2000 READINESS The Company is in the process of completing a review of its internal and external systems for Year 2000 readiness. The Company has identified those internal information technology systems and equipment or devices that it believes are dependent on compliance with Year 2000 programming (including embedded systems) and is currently in the process of determining whether these systems and equipment are Year 2000 ready. Additionally, the Company has compiled a list of all third parties with whom the Company has material relationships and is in the process of seeking information from these third parties regarding their state of readiness for Year 2000 compliance. The Company considers many of its relationships with third parties to be of a material nature, such that if these third parties are unable to become Year 2000 compliant, the Company would be adversely affected. These relationships encompass many areas that affect the Company's ability to do business including but not limited to third party manufacturers, 11 distributors, customers, suppliers, public utility companies, and financial institutions. The Company anticipates that sometime before the end of 1998, an assessment will have been made of the status of most of the Company's internal systems and equipment. Once this list is compiled, it will be prioritized for corrective actions and costs to correct will be estimated. Corrective actions, if needed, may include the purchase of new information technology applications, purchase of new equipment or devices, and identification of alternative suppliers. The costs for these corrective actions, if any, cannot be determined at this time. A contingency plan may need to be established if the corrective actions, if any, cannot be completed by the end of 1999. Such a plan has not yet been developed. At this time, the Company is unable to determine whether the Year 2000 issue will have a material adverse effect on the Company's results of operations, liquidity or financial position. There can be no assurances: 1) that the Company will be able to identify all aspects of its business that are subject to Year 2000 problems, including issues of its customers or suppliers, 2) that the Company's software vendors, third parties and others will be correct in their assertions that they are Year 2000 ready, and 3) that the Company's estimate of the cost of systems preparation for Year 2000 readiness will prove ultimately to be accurate. ____________________ THE STATEMENTS IN THIS QUARTERLY REPORT THAT ARE NOT DESCRIPTIONS OF HISTORICAL FACTS ARE FORWARD-LOOKING STATEMENTS. SUCH STATEMENTS REFLECT MANAGEMENT'S CURRENT VIEWS, ARE BASED ON CERTAIN ASSUMPTIONS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES, INCLUDING BUT NOT LIMITED TO, REGULATORY APPROVAL TIMING, PRODUCT DEMAND AND MARKET ACCEPTANCE RISKS, PATENT AND INTELLECTUAL PROPERTY RISKS, YEAR 2000 RISKS, THE EARLY STAGE OF PRODUCT DEVELOPMENT AND RELIANCE ON THIRD-PARTY MANUFACTURERS INCLUDING, BUT NOT LIMITED TO, CAPACITY AND SUPPLY CONSTRAINTS, PRODUCTION YIELDS, REGULATORY APPROVAL TIMING AND FOREIGN EXCHANGE RISKS, AS WELL AS OTHER RISKS DETAILED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE CURRENTLY ANTICIPATED AS A RESULT OF THE FOREGOING OR OTHER FACTORS. 12 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: None (b) Reports on Form 8-K:
Report Date Event reported 7/17/98 Biotransplant and MedImmune Report Phase II Results of BTI-322 to Treat Graft-Versus-Host Disease in Transplant Patients 7/24/98 MedImmune Revenues Increase Over 400 Percent in First Half 8/12/98 Abbott Laboratories and MedImmune Announce Submission of Application for European Marketing Approval of Synagis 9/9/98 FDA Approves Additional Manufacturing Facility for MedImmune's Synagis 9/9/98 Phase 3 Results for MedImmune's Synagis Published in Pediatrics 9/16/98 MedImmune and Chiron Enter Agreement on Vaccine Adjuvant Technology 9/16/98 MedImmune Appoints Melvin Booth President & Chief Operating Officer
13 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. MEDIMMUNE, INC. (Registrant) Date: November 13, 1998 /s/David M. Mott Vice Chairman and Chief Financial Officer 14 EX-27 2 FINANCIAL DATA SCHEDULE
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM MEDIMMUNE, INC'S QUARTERLY REPORT ON FORM 10-Q FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1998 AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FILING. 1,000 9-MOS DEC-31-1998 SEP-30-1998 22,422 77,928 16,188 0 24,136 144,045 69,020 0 219,656 34,360 83,878 0 0 267 99,989 219,656 73,224 107,769 43,661 126,299 0 0 3,061 (16,415) 0 (16,415) 0 0 0 (16,415) (0.62) (0.62)
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