MedImmune Reports Results For First Six Months Of 2001
Six Month Highlights
- Revenues reach $279 million
- Sales of Synagis® grow 29 percent
- Four new clinical trials started
- Initial clinical data for Siplizumab presented at International Psoriasis Symposium
- Acquisition of IL-9 from Genaera Corporation completed
Gaithersburg, MD, July 25, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) today announced that total revenues for the first six months of 2001 increased to $279 million from $241 million in the first six months of 2000. Driving revenue growth for the 2001 six-month period was a 29-percent increase in sales of Synagis (palivizumab) to wholesalers and distributors to $236 million ($220 million in the U.S.) from $184 million ($176 million in the U.S.) for the same period in 2000. Resales of Synagis by wholesalers and distributors to end-users (primarily hospitals and pediatricians) are estimated to have grown approximately 51 percent during the first six months of 2001 to $287 million ($265 million in the U.S.) from approximately $190 million ($178 million in the U.S.) for the same period of the previous year, reflecting a reduction in the amount of inventory held by distributors and wholesalers at the end of the 2000/2001 season. Synagis is the company's flagship product used to prevent respiratory syncytial virus (RSV) in high-risk infants. RSV is most commonly active in the Northern Hemisphere from late September to early May.
"We are pleased to report that sales of Synagis for the full 2000/2001 RSV season reached $480 million," stated David M. Mott, MedImmune's chief executive officer and vice chairman. "In addition to our strong financial performance, we are pleased with our progress in research and development thus far in 2001. We have commenced four new clinical trials, presented the first clinical results for siplizumab (MEDI-507) at the International Psoriasis Symposium in June, and added an exciting new preclinical target for asthma with the acquisition of IL-9 from Genaera."
Additional Results for Six Months Ended June 30, 2001
Product sales for the first six months of 2001 increased to $264 million from $221 million in the first six months of 2000. As mentioned above, sales of Synagis grew to $236 million ($220 million in the U.S.) during the first six months of 2001 from $184 million ($176 million in the U.S.) in 2000. Sales of CytoGam® (cytomegalovirus immune globulin intravenous (human)) in the 2001 period totaled $16 million and sales of Ethyol® (amifostine) were $6 million. In the 2000 period, sales of CytoGam totaled $20 million and Ethyol sales were $11 million. As stated above, total revenues for the six month period grew to $279 million in 2001 from $241 million in 2000.
MedImmune's net earnings for the first six months of 2001 grew to $69 million, or $0.32 per diluted share, from net earnings for the first six months of 2000 of $57 million, or $0.26 per diluted share, before the cumulative effect of a change in accounting principle for the 2000 period. Including the cumulative effect of a change in accounting principle, the company's net earnings for the first six months of 2000 were $23 million, or $0.11 per diluted share. Gross margins improved to 77 percent in the first six months of 2001 from 74 percent for the comparable 2000 period due to a change in product mix and improved manufacturing efficiencies for Synagis. Selling, general and administrative costs increased to $84 million in the 2001 period from $74 million in 2000 due primarily to an increase in sales support for Synagis. Total research and development costs increased 19 percent to $40 million in the 2001 period from $34 million in the 2000 period due to a larger number of active clinical trials. Other operating expenses increased to $6 million in the first six months of 2001 from $3 million in 2000.
Results for the Quarter Ended June 30, 2001
Product sales for the 2001 second quarter increased to $28 million from $25 million in the 2000 quarter. Driving the growth in product sales for the 2001 quarter was a 105-percent increase in sales of Synagis to wholesalers and distributors to $15 million ($8 million in the U.S.) from $7 million ($5 million in the U.S.) in the 2000 second quarter. Resales of Synagis by wholesalers and distributors to end-users during the 2001 second quarter are estimated to have increased about 102 percent to approximately $33 million ($29 million in the U.S.) from $16 million ($15 million in the U.S.) for the 2000 second quarter, again reflecting a reduction of wholesaler and distributor inventories at the end of the RSV season. Sales of CytoGam for the 2001 quarter totaled $8 million, while Ethyol sales totaled $3 million. In the second quarter of 2000, CytoGam sales totaled $10 million and Ethyol sales were $6 million. Total revenues for the 2001 quarter were $33 million compared to $35 million in the second quarter of 2000.
MedImmune's net loss for the 2001 second quarter was $9 million, or $0.04 per share, compared to a net loss of $5 million, or $0.03 per share, in the 2000 second quarter. Gross margins in the 2001 second quarter improved to 75 percent from 53 percent in the 2000 second quarter due to a change in product mix and improved manufacturing efficiencies for Synagis. Selling, general and administrative costs were $24 million for the 2001 second quarter compared to $23 million in the 2000 quarter. Due to a greater number of active research and clinical programs, research and development expenses increased 18 percent to $22 million in the 2001 quarter from $18 million in the second quarter of 2000.
Other operating expenses were $3 million in the 2001 quarter compared to $1 million in the 2000 quarter.
Cash and marketable securities at June 30, 2001 were $706 million compared to $526 million at December 31, 2000, primarily reflecting positive cash flow from operations.
Looking Ahead in 2001
The following forward-looking information is being provided as a convenience to investors. Investors should note that sales of Synagis occur primarily during the fourth and first quarters when RSV is most prevalent in the community. Results for the second and third quarters will reflect this seasonality. 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 $0.80 to $0.82
- Product sales are projected to grow 15 to 20 percent over 2000
- Worldwide end-user sales of Synagis are projected to increase to:
- $525 to $540 million for calendar year 2001
- $585 to $605 million for the 2001-2002 RSV season
- Total revenues are projected to exceed $600 million
- Gross margins are projected to improve modestly from 2000
- Research and development expenses are projected to increase 25 to 28 percent
- Selling, general and administrative expenses are projected to decrease modestly from 2000 as a percent of total revenues
- The tax rate is projected to be approximately 34 percent in 2001
For the quarter ending September 30, 2001:
- Diluted earnings per share are projected to range from $0.01 to $0.03
- Total revenues are projected to range from $57 to $62 million
MedImmune is offering a live webcast of a discussion by MedImmune management of its earnings and other business results on Wednesday, July 25, 2001 at 4:30 p.m. EDT. 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 August 1, 2001. An audio replay of the webcast will be available beginning at 8:00 p.m. EDT on July 25, 2001 until midnight August 1, 2001 by calling (719) 457-0820. The passcode for the audio replay is 629351.
Synagis® (palivizumab) 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). 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). 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, 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. 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 July 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 on Form 10-K for the year ended December 31, 2000 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 sells Synagis to wholesalers and distributors. MedImmune compiles and reports estimated amounts of resales of Synagis by those wholesalers and distributors to their end-user customers (primarily hospitals and pediatricians) based on unit resale data supplied to MedImmune by its wholesalers and distributors, multiplied by MedImmune's quarterly average selling price of Synagis. 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.
2001 Q2 Condensed Statements of Operations & Condensed Balance Sheets