[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2004
| Delaware | 0-19131 | 52-1555759 |
| (State or other jurisdiction of | (Commission File No.) | (I.R.S. Employer Identification No.) |
| incorporation or organization) |
One MedImmune Way,
Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code (301) 398-0000
35 West Watkins Mill
Road, Gaithersburg, MD 20878
(Former name, former address and former fiscal year, if changed since last report)
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 [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined by Rule 12b-2 of the Exchange Act). Yes [X] No [ ]As of April 30, 2004, 248,753,764 shares of Common Stock, par value $0.01 per share, were outstanding.
MEDIMMUNE, INC.
Index to Form 10-Q
| Page | ||||
|---|---|---|---|---|
| Part I-- FINANCIAL INFORMATION |
||||
| Item 1. Consolidated Financial Statements | ||||
| Consolidated Balance Sheets | 1 | |||
| Consolidated Statements of Operations | 2 | |||
| Condensed Consolidated Statements of Cash Flows | 3 | |||
| Notes to Consolidated Financial Statements | 4-9 | |||
| Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations | 10-18 | |||
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 18 | |||
| Item 4. Controls and Procedures | 19 | |||
| Part II-- OTHER INFORMATION | ||||
| Item 1. Legal Proceedings | 20 | |||
| Item 2. Changes in Securities, Use of Preceeds and Issuer Purchases of Equity Securities | 20 | |||
| Item 3. Defaults Upon Senior Securities | 20 | |||
| Item 4. Submission of Matters to a Vote of Security Holders | 20 | |||
| Item 5. Other Information | 20 | |||
| Item 6. Exhibits and Reports on Form 8-K | 20 | |||
Trademark information: Synagis® (palivizumab), CytoGam® (cytomegalovirus immune globulin intravenous (human)), RespiGam® (respiratory syncytial virus immune globulin intravenous (human)), and Vitaxin® are registered trademarks of MedImmune, Inc. NumaxTM is a trademark of MedImmune, Inc. Ethyol® (amifostine) and NeuTrexin® (trimetrexate glucuronate for injection) are registered trademarks of MedImmune Oncology, Inc. FluMistTM (Influenza Virus Vaccine Live, Intranasal) is a trademark of MedImmune Vaccines, Inc. |
_________________
Unless otherwise indicated, this quarterly report is as of March 31, 2004. This quarterly report will not be updated as a result of new information or future events.
(in thousands)
| March 31, | December 31, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2004 |
2003 | |||||||
| (Unaudited) | ||||||||
| ASSETS: | ||||||||
| Cash and cash equivalents | $ | 300,371 | $ | 515,502 | ||||
| Marketable securities | 288,113 | 272,765 | ||||||
| Trade receivables, net | 149,847 | 161,229 | ||||||
| Inventory, net | 59,308 | 91,703 | ||||||
| Deferred tax assets | 22,699 | 29,322 | ||||||
| Other current assets | 23,387 | 32,233 | ||||||
| Total Current Assets | 843,725 | 1,102,754 | ||||||
| Marketable securities | 1,370,307 | 1,111,882 | ||||||
| Property and equipment, net | 281,657 | 273,597 | ||||||
| Deferred tax assets, net | 106,962 | 151,280 | ||||||
| Intangible assets, net | 92,592 | 96,694 | ||||||
| Goodwill | 13,614 | 13,614 | ||||||
| Other assets | 51,516 | 44,849 | ||||||
| Total Assets | $ | 2,760,373 | $ | 2,794,670 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY: | ||||||||
| Accounts payable | $ | 19,342 | $ | 22,116 | ||||
| Accrued expenses | 246,221 | 217,915 | ||||||
| Product royalties payable | 82,936 | 81,808 | ||||||
| Advances from Wyeth | 24,401 | 51,910 | ||||||
| Taxes Payable | 25,294 | 120 | ||||||
| Other current liabilities | 11,899 | 16,846 | ||||||
| Total Current Liabilities | 410,093 | 390,715 | ||||||
| Long-term debt | 506,903 | 681,223 | ||||||
| Obligations to Evans | 21,765 | 21,627 | ||||||
| Other liabilities | 1,790 | 1,887 | ||||||
| Total Liabilities | 940,551 | 1,095,452 | ||||||
| Commitments and Contingencies | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Preferred stock, $.01 par value; authorized 5,525 shares; none issued or | ||||||||
| outstanding | -- | -- | ||||||
| Common stock, $.01 par value; authorized 420,000 shares; outstanding | ||||||||
| 248,258 at March 31, 2004 and 248,036 at December 31, 2003 | 2,545 | 2,543 | ||||||
| Paid-in capital | 2,675,430 | 2,673,059 | ||||||
| Deferred compensation | (889 | ) | (1,379 | ) | ||||
| Accumulated deficit | (661,908 | ) | (772,936 | ) | ||||
| Accumulated other comprehensive income | 34,446 | 27,733 | ||||||
| 2,049,624 | 1,929,020 | |||||||
| Less: Treasury stock at cost; 6,239 shares at March 31, 2004 and December 31, 2003 | ||||||||
| 2003 | (229,802 | ) | (229,802 | ) | ||||
| Total Shareholders' Equity | 1,819,822 | 1,699,218 | ||||||
| Total Liabilities and Shareholders' Equity | $ | 2,760,373 | $ | 2,794,670 | ||||
The accompanying notes are an integral part of these financial statements.
(in thousands, except per share data)
| For the | ||||||||
|---|---|---|---|---|---|---|---|---|
| three months ended | ||||||||
| March 31, | ||||||||
| 2004 |
2003 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 483,209 | $ | 431,109 | ||||
| Other revenue | 5,792 | 3,511 | ||||||
| Total revenues | 489,001 | 434,620 | ||||||
| Costs and expenses: | ||||||||
| Cost of sales | 158,193 | 103,340 | ||||||
| Research and development | 49,764 | 31,671 | ||||||
| Selling, general and administrative | 123,732 | 115,244 | ||||||
| Other operating expenses | 1,818 | 21,456 | ||||||
| Total expenses | 333,507 | 271,711 | ||||||
| Operating income | 155,494 | 162,909 | ||||||
| Interest income | 16,673 | 12,990 | ||||||
| Interest expense | (2,166 | ) | (1,799 | ) | ||||
| Gain (loss) on investment activities | 6,234 | (257 | ) | |||||
| Earnings before income taxes | 176,235 | 173,843 | ||||||
| Provision for income taxes | 65,207 | 64,322 | ||||||
| Net earnings | $ | 111,028 | $ | 109,521 | ||||
| Basic earnings per share | $ | 0.45 | $ | 0.44 | ||||
| Shares used in calculation of basic earnings per share | 248,180 | 251,499 | ||||||
| Diluted earnings per share | $ | 0.44 | $ | 0.43 | ||||
| Shares used in calculation of diluted earnings per share | 250,896 | 256,514 | ||||||
The accompanying notes are an integral part of these financial statements.
(in thousands)
| For the three months ended | ||||||||
|---|---|---|---|---|---|---|---|---|
| March 31, | ||||||||
| 2004 |
2003 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net earnings | $ | 111,028 | $ | 109,521 | ||||
| Adjustments to reconcile net earnings to net cash provided by operating activities: | ||||||||
| Deferred taxes | 45,371 | 66,247 | ||||||
| Deferred revenue | (122 | ) | (1,676 | ) | ||||
| Advances from Wyeth | (27,509 | ) | -- | |||||
| Depreciation and amortization | 10,624 | 10,736 | ||||||
| Amortization of premium on marketable securities | 3,541 | 3,258 | ||||||
| Amortization of deferred compensation | 360 | 1,641 | ||||||
| Amortization of premium on convertible subordinated notes | (391 | ) | (466 | ) | ||||
| Amortization of bond issuance costs | 891 | -- | ||||||
| Realized (gains) losses on investments | (6,234 | ) | 257 | |||||
| Gain on early redemption of convertible notes | (1,010 | ) | -- | |||||
| Losses on write downs of inventory | 18,572 | 20,786 | ||||||
| Increase (decrease) in sales allowances | 18,082 | (3,500 | ) | |||||
| Other | (632 | ) | 449 | |||||
| Other changes in assets and liabilities | 62,686 | 16,583 | ||||||
| Net cash provided by operating activities | 235,257 | 223,836 | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Increase in marketable securities | (251,935 | ) | (106,926 | ) | ||||
| Capital expenditures | (14,472 | ) | (21,793 | ) | ||||
| Investments in strategic alliances | (12,500 | ) | -- | |||||
| Net cash used in investing activities | (278,907 | ) | (128,719 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from issuance of common stock | 1,424 | 8,182 | ||||||
| Debt prepayments | (172,677 | ) | -- | |||||
| Repayments on long-term obligations | (220 | ) | (206 | ) | ||||
| Net cash (used in) provided by financing activities | (171,473 | ) | 7,976 | |||||
| Effect of exchange rate changes on cash | (8 | ) | (54 | ) | ||||
| Net (decrease) increase in cash and cash equivalents | (215,131 | ) | 103,039 | |||||
| Cash and cash equivalents at beginning of period | 515,502 | 130,056 | ||||||
| Cash and cash equivalents at end of period | $ | 300,371 | $ | 233,095 | ||||
The accompanying notes are an integral part of these financial statements.
MedImmune, Inc., a Delaware corporation (together with its subsidiaries, the Company), is a biotechnology company headquartered in Gaithersburg, Maryland. The Company currently actively markets four products, Synagis, Ethyol, CytoGam, and FluMist, and maintains a diverse research and development pipeline. The Company is focused on developing vaccines and antibodies that address significant medical needs in the areas of infectious diseases, immunology and oncology.
General
The financial information presented
for the three months ended March 31, 2004 (Q1 2004) and for the three months
ended March 31, 2003 (Q1 2003) is unaudited. In the opinion of the
Companys management, the financial information presented herein contains all
adjustments, which consist only of normal recurring adjustments, necessary for a fair
presentation of results for the interim periods presented. Interim results are not
necessarily indicative of results for an entire year or for any subsequent interim period.
These consolidated financial statements should be read in conjunction with the
Companys annual report on Form 10-K for the year ended December 31, 2003.
Stock-based Compensation
Compensation costs attributable to
stock option and similar plans are recognized based on any excess of the quoted market
price of the stock on the date of grant over the amount the employee is required to pay to
acquire the stock, in accordance with the intrinsic-value method under Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees
(APB 25). Such amount, if any, is accrued over the related vesting period.
In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure (SFAS 148). SFAS 148 amends SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, SFAS 148 amends the disclosure requirements of SFAS 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. The alternative methods of transition and additional disclosure requirements of SFAS 148 were effective January 1, 2003.
The following table illustrates the effect on net earnings and earnings per share if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in millions, except per share data):
| Q1 | Q1 | |||||||
|---|---|---|---|---|---|---|---|---|
| 2004 |
2003 | |||||||
| Net earnings, as reported | $ | 111.0 | $ | 109.5 | ||||
| Add: stock-based employee compensation expense included in historical results for the | ||||||||
| vesting of stock options assumed in conjunction with the acquisition of Aviron, | ||||||||
| calculated in accordance with FIN 44, Accounting for Certain Transactions Involving | ||||||||
| Stock Compensation-an Interpretation of APB 25, net of related tax effect | 0.2 | 1.0 | ||||||
| Deduct: stock-based employee compensation expense determined under the fair value based | ||||||||
| method for all awards, net of related tax effect | (16.2 | ) | (24.3 | ) | ||||
| Pro forma net earnings | $ | 95.0 | $ | 86.2 | ||||
| Basic earnings per share, as reported | $ | 0.45 | $ | 0.44 | ||||
| Basic earnings per share, pro forma | $ | 0.38 | $ | 0.34 | ||||
| Diluted earnings per share, as reported | $ | 0.44 | $ | 0.43 | ||||
| Diluted earnings per share, pro forma | $ | 0.38 | $ | 0.34 | ||||
Reclassifications
Certain prior year amounts have been
reclassified to conform to the current presentation.
Intangible assets are stated at amortized cost. The Company reviews its intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Intangible assets at March 31, 2004 are comprised of the following (in millions):
| Worldwide collaboration with Wyeth | $ | 90.0 | |||
| Contract manufacturing agreement with Evans | 39.0 | ||||
| Other intangible assets | 0.4 | ||||
| 129.4 | |||||
| Less accumulated amortization | (36.8 | ) | |||
| $ | 92.6 | ||||
Amortization of intangible assets is computed on the straight-line method based on the estimated useful lives of the assets. Amortization expense for Q1 2004 and Q1 2003 was $4.4 million and $4.2 million, respectively. As of March 31, 2004, FluMist inventory includes approximately $0.3 million of amortization costs associated with the contract manufacturing agreement with Evans. The estimated aggregate amortization for the Evans agreement for the remainder of 2004 through 2006 is as follows: 2004, $6.5 million; 2005, $8.7 million; and 2006, $4.4 million.
As a result of entering into agreements to dissolve the collaboration with Wyeth during April 2004 (see Note 11), assuming consummation of the transactions contemplated by these agreements, the Company will record a permanent impairment loss of $73.0 million during the quarter ended June 30, 2004 to write off the remaining unamortized cost of the intangible asset.
Inventory, net of write-downs, is comprised of the following (in millions):
| March 31, | December 31, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2004 |
2003 | |||||||
| By Component | ||||||||
| Raw Materials, net | $ | 11.8 | $ | 11.6 | ||||
| Work in Process, net | 38.4 | 39.3 | ||||||
| Finished Goods, net | 9.1 | 40.8 | ||||||
| $ | 59.3 | $ | 91.7 | |||||
During Q1 2004, the Company recorded permanent inventory write downs totaling $13.5 million in cost of goods sold to reflect total FluMist inventories at net realizable value. During Q1 2003, prior to regulatory approval, the Company recorded permanent inventory write downs totaling $19.6 million to other operating expenses to reflect total FluMist inventories at net realizable value.
The following is a reconciliation of the denominators of the diluted EPS computation for Q1 2004 and Q1 2003. There are no reconciling items to the numerator for the EPS computation for the periods reported (in millions).
| Q1 | Q1 | |||||||
|---|---|---|---|---|---|---|---|---|
| 2004 |
2003 | |||||||
| Denominator: | ||||||||