MedImmune Sets New Revenue and Earnings Records
Net Earnings Grow 65 Percent in Fourth Quarter 2000*
*Excluding impact of cumulative effect of accounting principle change and one-time items
- Revenues Increase 41 Percent
- Synagis Sales Grow 46 Percent
- Net Earnings and EPS More than Double to $147 Million and $0.67*
Gaithersburg, MD, January 25, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) today reported a 37-percent increase in total revenues for the 2000 fourth quarter over the same period in 1999. Total revenues of $238.2 million in the 2000 fourth quarter included product sales of $227.4 million and $10.8 million in other revenues. Total revenues of $173.7 million in the 1999 fourth quarter included product sales of $171.5 million and $2.2 million in other revenues. The primary growth driver for the 2000 quarter was a 40-percent increase in worldwide sales of Synagis® (palivizumab) to $211.8 million ($201.0 million in the U.S.) from $151.1 million ($147.3 million in the U.S) in the 1999 fourth quarter. Also contributing to product sales for the 2000 fourth quarter were $8.0 million in worldwide sales of CytoGam® (Cytomegalovirus Immune Globulin Intravenous (Human)) and $5.0 million in revenues from Ethyol® (amifostine). In the 1999 fourth quarter, sales of CytoGam totaled $12.4 million and Ethyol revenues totaled $6.0 million.
“2000 was another excellent year for MedImmune,” said David M. Mott, MedImmune's chief executive officer. “We recorded our third consecutive year of both record revenues and record earnings, driven by compound annual growth in revenues of 72 percent over the same period. We generated over $250 million in free cashflow in 2000 and we now have over $1 billion in assets. During 2000 we made tremendous progress in moving forward with our seven products currently in clinical testing and we also identified a number of new preclinical product candidates for future development. In 2001, we look forward to delivering another record year of financial results and to making even greater progress on bringing our next products to the marketplace.”
Additional Fourth Quarter Results
Net earnings excluding one-time items for the 2000 fourth quarter grew 65 percent to $81.6 million, or $0.37 per diluted share. Net earnings including one-time items in the 2000 fourth quarter were $79.4 million, or $0.36 per diluted share. Excluding one-time items in the 1999 fourth quarter, net earnings were $49.4 million, or $0.23 per diluted share. Including one-time items, net earnings for the 1999 fourth quarter were $34.2 million, or $0.16 per diluted share. One-time items in the 2000 quarter were associated with the company's plasma production activities and consist of the write-off of certain equipment and by-product inventory. One-time items in 1999 were transaction expenses associated with the completed acquisition of U.S. Bioscience, Inc. in November 1999.
Gross margins for both the 2000 and 1999 fourth quarters excluding one-time items were 77 percent. Selling, general and administrative costs rose to $59.3 million in the 2000 fourth quarter from $41.9 million in 1999 fourth quarter excluding one-time items, reflecting the impact of higher co-promotion-related expenses for Synagis® and certain legal expenses. Research and development expenses increased to $17.6 million in the fourth quarter 2000 from $16.2 million in fourth quarter 1999, reflecting the progression of several clinical programs. Other operating expenses excluding one-time items in the fourth quarter 2000 grew slightly to $1.4 million from $1.1 million in 1999 fourth quarter.
For the year ended December 31, 2000, MedImmune reported revenues of $540.5 million, a 41-percent increase over 1999 when revenues totaled $383.4 million. Product sales in 2000 totaled $495.8 million and included $427.0 million in sales of Synagis, $36.5 million in sales of CytoGam, and $21.4 million in revenues from sales of Ethyol. In 1999, product sales of $356.8 million included $293.0 million in sales of Synagis, $34.7 million in sales of CytoGam, and $19.6 million in revenues from sales of Ethyol. Other revenues in 2000 totaled $44.7 million, compared to $26.6 million in 1999.
Net earnings in 2000 were $147.2 million, or $0.67 per diluted share, excluding one-time items and the impact of the cumulative effect of a change in accounting principle as a result of implementing the SEC's Staff Accounting Bulletin No. 101 (see details below). Including one-time items and before the cumulative effect adjustment in 2000, net earnings were $145.0 million, or $0.66 per diluted share. Net earnings in 2000 were $111.2 million, or $0.50 per diluted share. Excluding one-time items in 1999, net earnings were $68.7 million, or $0.33 per diluted share. Including one-time items, net earnings for 1999 were $93.4 million, or $0.44 per diluted share. One-time items in 2000 were associated with the company's plasma production activities and consist of the write-off of certain equipment and by-product inventory. One-time items in 1999 were related to the acquisition of U.S. Bioscience. These one-time items included a tax benefit of $41.0 million, accounted for in the second quarter of 1999, associated with the reversal of the valuation allowance on U.S. Bioscience's deferred tax asset, and $1.8 million and $19.4 million of merger related costs accounted for in the third and fourth quarters of 1999, respectively, less the related tax effect.
Gross margins for both 2000 and 1999 excluding one-time items were 75 percent. Selling, general and administrative expenses in 2000 rose to $157.3 million from $118.2 million in 1999 excluding one-time items, primarily reflecting increased promotional and co-promotional expenses related to Synagis and certain legal expenses. Research and development costs increased in 2000 to $66.3 million from $59.6 million in 1999, reflecting a larger number of active clinical studies. Other operating expenses excluding one-time items for 2000 were $7.2 million, a decrease of 59 percent from the previous year when other operating expenses totaled $17.4 million, primarily reflecting decreased start-up costs for MedImmune's manufacturing facility in Frederick, Maryland.
Cash and marketable securities at December 31, 2000 nearly doubled to $526.3 million from $270.4 million at December 31, 1999.
Impact of SAB 101
MedImmune's fourth quarter and full year results have been adjusted in this release to reflect implementation of the U.S. Securities and Exchange Commission Staff Accounting Bulletin No. 101. An 8-K was filed on January 25, 2001 to show the impact of this change in accounting principle on the first three quarters of 2000.
SAB No. 101 generally provides that nonrefundable up-front fees received under collaborative agreements be recognized over future periods rather than upon receipt. As a result of the implementation of SAB No. 101, the company recognized $4.0 million and $21.1 million in additional revenue for the three months and year ended December 31, 2000, respectively. The cumulative effect of changing the accounting policy for the company's recognition of up-front nonrefundable fees received under collaborative agreements resulted in a non-cash charge of $33.8 million net of tax for the year ended December 31, 2000. If the company had not been required to implement SAB No. 101, the reported earnings per share on a diluted basis before one-time items would have been $0.36 and $0.61 for the three months and year ended December 31, 2000, respectively.
Looking Ahead to 2001
The following forward-looking information is being provided as a convenience to investors. These projections are based upon numerous assumptions which MedImmune cannot control and which may not develop as MedImmune expects. Consequently, actual results may differ materially from the projections made here. Please refer to the Disclosure Notice below:
For the year ending December 31, 2001:
- Diluted earnings per share are projected to be in the range of $0.80 to $0.85
- Product sales are projected to grow in the range of 15 to 20 percent over 2000
- Total revenues are projected to exceed $600 million
- Gross margins are projected to be comparable to 2000
- Research and development expenses are projected to increase 15 to 20 percent over 2000
- Selling, general and administrative expenses are projected to decrease approximately 2 to 5 percent from 2000 as a percent of total revenues
- The tax rate is projected to be approximately 35 percent in 2001
Worldwide end-user sales of Synagis are projected to grow 25 to 30 percent for the current RSV season and 20 to 25 percent next season as follows:
- 2000-2001 RSV season: $465 to $485 million ($425 to $435 million in the U.S.
- 2001- 2002 RSV season: $580 to $600 million ($500 to $510 million in the U.S.)
For the quarter ending March 31, 2001:
- Diluted earnings per share are projected to range from $0.34 to $0.36
- Total revenues are projected to range from $240 to $250 million
MedImmune is offering a live webcast of a discussion by MedImmune management of its earnings and other business results on Thursday, January 25, 2001 at 5:00 p.m. EST. The live webcast may be accessed on MedImmune's website at www.medimmune.com. A replay of the webcast will also be available via our website until February 1, 2001. An audio replay of the webcast will be available beginning at 8:00 p.m. EST on January 25, 2001 until midnight February 1, 2001 by calling (719) 457-0820. The passcode for the audio replay is 426425.
Synagis® is marketed for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere from October through May (see full prescribing information at www.medimmune.com/ medimmune/products/synagispi.htm). Ethyol® is marketed for the reduction of both cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer or non-small cell lung cancer (“NSCLC”) and moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid (see full prescribing information at www.medimmune.com/medimmune/ products/ethyol.htm). CytoGam® is marketed for the prophylaxis against cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart (see full prescribing information at www.medimmune.com/medimmune/ products/cytopi1.htm).
MedImmune, Inc. is a fully integrated biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands, and an oncology subsidiary in West Conshohocken, Pennsylvania. For more information on MedImmune, visit the company's website at www.medimmune.com.
DISCLOSURE NOTICE: The information contained in this document is as of January 25, 2001, and will not be updated as a result of new information or future events. This document contains forward - looking statements regarding MedImmune's future financial performance and business prospects. Those statements involve substantial risks and uncertainties. You can identify those statements by the fact that they contain words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “project” or other terms of similar meaning. Those statements reflect management's current beliefs and are based on numerous assumptions which MedImmune cannot control and which may not develop as MedImmune expects. Consequently, actual results may differ materially from those projected in the forward - looking statements. Among the factors that could cause actual results to differ materially are: seasonal demand for and continued supply of our principal product; availability of competitive products in the market; availability of third-party reimbursement for the cost of our products; effectiveness and safety of our products; exposure to product liability and other types of lawsuits; foreign currency exchange rate fluctuations; changes in generally accepted accounting principles; growth in costs and expenses; the impact of acquisitions, divestitures and other unusual items; and the risks, uncertainties and other matters discussed in MedImmune's Annual Report of Form 10-K for the year ended December 31, 1999 and in its periodic reports on Forms 10-Q and 8-K (if any) filed with the U.S. Securities and Exchange Commission. MedImmune cautions that RSV disease occurs primarily during the winter months; MedImmune believes its operating results will reflect that seasonality for the foreseeable future. MedImmune is also developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.
2000 Q4 Condensed Statements of Operations & Condensed Balance Sheets