Fourth Quarter 2001 Revenues Reach $293 Million and Net Earnings
Grow to $99 Million
2001 Highlights
* Revenues reach $619 million and net earnings grow 34 percent
* Announced $1.5 billion acquisition of Aviron
* Reacquired U.S. marketing rights for Ethyol(R) (amifostine) effective
October 1
* Gained FDA approval for industry-leading Enhanced Yield Manufacturing
process for Synagis(R) (palivizumab)
* In-licensed new antibody technologies: IL-9 for asthma and EphA2 for
cancer
* Nine clinical trials initiated and enrollment complete in 12 trials
GAITHERSBURG, Md., Jan. 24 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq:
MEDI) today reported that net earnings for the year ended December 31, 2001
increased 34 percent to $149 million, or $0.68 per diluted share, on total
revenues of $619 million. In 2000, net earnings were $111 million, or $0.50 per
diluted share, on total revenues of $540 million. Revenue growth was primarily
driven by increases in worldwide sales of Synagis. During 2001, worldwide sales
of Synagis to wholesalers and distributors grew 21 percent to $516 million ($480
million in the U.S.) from $427 million ($399 million in the U.S.) in 2000.
"2001 was our fourth straight record year for revenues and earnings," said David
M. Mott, MedImmune's chief executive officer. "During 2001, we also made several
important strategic investments in our future, including the $1.5 billion
acquisition of Aviron, the acquisition of U.S. marketing rights for Ethyol, and
the in-licensing of the IL-9 asthma and EphA2 cancer programs. We advanced our
R&D pipeline, initiating nine new clinical trials and completing patient
enrollment in 12 trials. We capitalized on an R&D breakthrough with the FDA
licensure of the Enhanced Yield Process for production of Synagis. We generated
over $250 million in free cashflow, and ended the year with $788 million in cash
and marketable securities and more than $1.2 billion in assets. We enter 2002
with a continued passion for advancing science, improving patients' lives and
creating shareholder value."
Additional Results for the Year Ended December 31, 2001
Gross margins for 2001 improved to 76 percent from 74 percent in 2000 due to a
change in product mix and improved manufacturing efficiencies for Synagis.
Selling, general and administrative costs increased to $195 million in 2001 from
$157 million in 2000 due primarily to costs associated with the previously
announced reacquisition of U.S. rights to Ethyol from ALZA Corporation in the
2001 third quarter, and an increase in sales support for Synagis. Total research
and development costs increased to $83 million in 2001 from $66 million in 2000
due to a larger number of active clinical trials. Other operating expenses in
both 2001 and 2000 were approximately $9 million.
Results for the Fourth Quarter Ended December 31, 2001
Total revenues for the 2001 fourth quarter grew 23 percent to $293 million from
$238 million in the 2000 fourth quarter. Contributing to the increase in total
revenues was a 21-percent increase in product sales, driven primarily by $250
million in worldwide sales of Synagis ($238 million in U.S.) to wholesalers and
distributors. This compares to the fourth quarter of 2000 when worldwide sales
of Synagis to wholesalers and distributors totaled $212 million ($201 million in
U.S.). Resales of Synagis by wholesalers and distributors to end-user customers
during the 2001 fourth quarter are estimated to have grown 34 percent to $254
million ($225 million in the U.S.) from an estimated $189 million ($170 million
in the U.S.) for the 2000 fourth quarter.
Net earnings for the 2001 fourth quarter grew 24 percent to $99 million, or
$0.45 per diluted share, from $79 million, or $0.36 per diluted share, in the
2000 fourth quarter. Gross margins in the 2001 fourth quarter increased to 77
percent from 76 percent in the 2000 quarter due to a change in product mix and
improved manufacturing efficiencies for Synagis. Selling, general and
administrative costs grew to $67 million for the 2001 quarter from $59 million
in the 2000 quarter due to an increase in sales support for Synagis. As a result
of a greater number of active research, development and clinical programs,
research and development expenses increased to $21 million in the 2001 quarter
from $18 million in the 2000 quarter. Other operating expenses decreased to $2
million in the 2001 quarter compared to $3 million in the 2000 quarter.
Looking Ahead in 2002
MedImmune is providing the following forward-looking information as a
convenience to investors. The guidance and objectives assume both the continued
growth and success of MedImmune's existing business (primarily including sales
of Synagis, Ethyol and CytoGam and the regulatory approval and successful launch
of FluMist(TM) in the U.S. in third-quarter 2002. FluMist was acquired as a part
of MedImmune's acquisition of Aviron, a formerly public company whose 2001
financial results will be subsequently filed with the U.S. Securities and
Exchange Commission through an 8-K submission. These projections are based upon
numerous assumptions, many of which MedImmune cannot control and which may not
develop as MedImmune expects. Consequently, actual results may differ materially
from the guidance and objectives described herein. Please refer to the
Disclosure Notice below. Guidance and objectives provided below refer to cash
earnings per share which exclude the impact of any in-process R&D writeoffs,
amortization of intangibles, transaction-related expenses and other one-time
items.
For the year ending December 31, 2002:
* Cash earnings per share are projected to be in the range of $0.65 to
$0.70
* Total revenues are projected to reach approximately $900 million
* For the 2001-2002 RSV season, worldwide end-user sales of Synagis are
projected to increase to $600 to $620 million
* Gross margins are projected to be approximately 74 percent
* Research and development expenses are projected to be in the range of
15 to 16 percent of total revenues
* Selling, general and administrative expenses are projected to be in
the range of 28 to 29 percent of total revenues
* Other operating expense is expected to range from $70 to $75 million
(driven by manufacturing start-up costs for FluMist in anticipation of
regulatory approval)
* The tax rate is projected to be approximately 35 percent in 2002
For the quarter ending March 31, 2002:
* Cash earnings per share are projected to range from $0.27 to $0.29
* Total revenues are projected to range from $315 to $325 million
Webcast
MedImmune is offering a live webcast of a discussion by MedImmune management of
its earnings and other business results on Thursday, January 24, 2002 at 4:30
p.m. EST. The live webcast may be accessed on MedImmune's website at
http://www.medimmune.com . A replay of the webcast will also be available via
our website until January 31, 2002. An audio replay of the webcast will be
available beginning at 7:30 p.m. EST on January 24, 2002 until 5:00 p.m. January
31, 2002 by calling 719-457-0820. The passcode for the audio replay is 573086.
MedImmune is a leading biotechnology company focused on researching, developing
and commercializing products to prevent or treat infectious disease, autoimmune
disease and cancer. MedImmune currently markets three products, Synagis(R)
(palivizumab), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune
globulin intravenous (human)), and has 12 products in clinical testing.
MedImmune employs over 1,400 people, is headquartered in Gaithersburg, Maryland,
and has additional operations in Frederick, Maryland, as well as Pennsylvania,
California, the United Kingdom and the Netherlands. For more information on
MedImmune, visit the company's website at http://www.medimmune.com .
Synagis(R) 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 http://www.medimmune.com ).
Ethyol(R) 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 http://www.medimmune.com ).
CytoGam(R) is marketed for the prophylaxis against cytomegalovirus disease
associated with transplantation of kidney, lung, liver, pancreas, and heart (see
full prescribing information at http://www.medimmune.com ). FluMist(TM) is
MedImmune's investigational live attenuated intranasal influenza vaccine
currently under review by the U.S. Food and Drug Administration.
DISCLOSURE NOTICE: The information contained in this document is as of January
24, 2002, 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 the quarterly average selling price
of Synagis to wholesalers and distributors. 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.
MedImmune, Inc. Selected Financial Information
(in thousands, except per share data)
Condensed Consolidated Statements of Operations
Three Months Year Ended
Ended December 31, December 31,
2001 2000 2001 2000
Revenues: (unaudited)
Product sales $276,021 $227,394 $579,529 $495,803
Other revenue 16,682 10,778 39,150 44,692
292,703 238,172 618,679 540,495
Costs and expenses:
Cost of sales 62,437 54,504 138,707 127,320
Research and
development 21,369 17,591 82,985 66,296
Selling, general
and administrative 66,671 59,256 194,841 157,330
Other operating
expenses 1,937 3,443 9,606 9,231
152,414 134,794 426,139 360,177
Interest income, net 7,955 8,589 35,926 29,095
Earnings before
income taxes and
cumulative effect of
a change in
accounting principle 148,244 111,967 228,466 209,413
Provision for income
taxes 49,738 32,525 79,506 64,436
Earnings before
cumulative effect of
a change in
accounting principle 98,506 79,442 148,960 144,977
Cumulative effect of
a change in accounting
principle, net of
tax benefit - - - (33,821)
Net earnings $98,506 $79,442 $148,960 $111,156
Basic earnings per share:
Earnings before
cumulative effect of
a change in
accounting principle $0.46 $0.38 $0.70 $0.69
Cumulative effect
of a change in
accounting principle,
net of tax benefit - - - (0.16)
Net earnings $0.46 $0.38 $0.70 $0.53
Shares used in
computing basic
earnings per share 214,273 211,068 213,378 209,101
Diluted earnings per share:
Earnings before
cumulative effect of
a change in
accounting principle $0.45 $0.36 $0.68 $0.66
Cumulative effect of
a change in accounting
principle, net of tax
benefit - - - (0.16)
Net earnings $0.45 $0.36 $0.68 $0.50
Shares used in
computing diluted
earnings per share 220,582 220,816 220,101 220,428
Condensed Consolidated Balance Sheets
December 31, December 31,
2001 2000
Assets:
Cash and marketable securities $787,690 $526,254
Trade and contract receivables, net 110,491 121,294
Inventory, net 52,691 48,965
Deferred taxes, net 163,641 217,080
Property and equipment, net 95,402 86,383
Other assets 9,471 6,599
$1,219,386 $1,006,575
Liabilities and shareholders' equity:
Accounts payable $5,873 $3,090
Accrued expenses 142,685 112,712
Other liabilities 17,011 36,889
Long term debt 9,544 10,302
Shareholders' equity 1,044,273 843,582
$1,219,386 $1,006,575
Common shares outstanding 214,484 211,348
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SOURCE MedImmune, Inc.
CONTACT: Lori Weiman, Senior Director, Corporate Communications,
+1-301-527-4321, or William Roberts, Manager, Investor Relations,
+1-301-527-4358, both of MedImmune, Inc.
URL: http://www.medimmune.com
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