GAITHERSBURG, Md., May 22 /PRNewswire-FirstCall/ -- At its Annual Meeting
of Shareholders held today in Gaithersburg, Maryland, MedImmune, Inc.
(Nasdaq: MEDI) provided an update on its corporate progress to its investors,
and reiterated its guidance issued on April 24, 2003.
During the Annual Meeting, shareholders approved all proposals outlined in
MedImmune's 2003 Proxy Statement, including the reelection of the Board of
Directors and the ratification of PricewaterhouseCoopers LLP as the company's
auditors. Other items approved were the 2003 Non-Employee Directors Stock
Option Plan, and amendments to the Restated Certification of Incorporation and
the 1999 Stock Option Plan.
David M. Mott, MedImmune's chief executive officer, told shareholders:
"MedImmune has a tremendous record of success having increased revenues at a
compound annual rate of 30 percent over the past three years and 48 percent
over the past decade. MedImmune is now one of the largest biotechnology
companies in the world at a $9 billion market capitalization, with three
marketed products, a robust R&D pipeline, more than $1.6 billion in cash and
marketable securities, and over 1,700 employees."
Mott added, "In 2003, our objectives include launching our second
potential blockbuster product, FluMist(TM), and surpassing $1 billion in
annual revenues for the first time."
MedImmune's Reconfirmed Financial Guidance
MedImmune's financial guidance, as originally provided on April 24, 2003
and as reconfirmed without change at today's Shareholders' Meeting, includes
guidance in accordance with generally accepted accounting principles (GAAP)
and adjusted guidance, as well as a reconciliation between the two, as a
convenience to its investors. MedImmune computes 2003 adjusted earnings by
adding back amounts that are related to the acquisition of MedImmune Vaccines,
Inc. (formerly Aviron) in January 2002. These amounts include: amortization
of intangible assets; compensation expense associated with the assumption and
vesting of unvested stock options, retention and severance payments; and
amortization of premium on convertible subordinated notes.
To reconcile MedImmune's adjusted guidance to its GAAP guidance for 2003,
the following acquisition-related expenses should be excluded from the GAAP
guidance: approximately $5 million in cost of sales; approximately $2 million
in R&D; approximately $9 million in SG&A; and approximately $4 million in
other operating expenses. In addition, approximately $2 million of net
interest income should be excluded from the GAAP guidance to reconcile to the
adjusted guidance. The guidance and objectives provided below are projections
and are based upon numerous assumptions, many of which MedImmune cannot
control and that may not develop as MedImmune expects. Consequently, actual
results may differ materially from the guidance and objectives described in
this release. Please refer to the Disclosure Notice below.
Guidance for the Year Ending December 31, 2003
Revenue Guidance for 2003
* Total revenues: $1.08 billion to $1.13 billion (27% to 33% growth
over 2002)
-- Product sales: 24% to 28% over 2002
-- Synagis(R) revenues: 20% to 24% over 2002
-- Ethyol(R) revenues: 20% to 25% over 2002
-- Total FluMist revenue (product sales and other revenues from
milestones and royalties): $120 million to $140 million
GAAP Guidance for 2003
* Earnings per diluted share: $0.84 to $0.89 (compared to a loss of
$4.40 per share for 2002)
* Gross margins: approximately 71% of product sales
* R&D: $152 million to $157 million
* SG&A: 34% to 35% of product sales
* Other operating expenses: $21 million to $24 million
* Tax rate: approximately 37%
Adjusted Guidance for 2003
* Earnings per diluted share: $0.88 to $0.93 (110% to 121% growth over
2002)
* Gross margins: approximately 71% of product sales
* R&D: $150 million to $155 million
* SG&A: 33% to 34% of product sales
* Other operating expenses: $17 million to $20 million
* Tax rate: approximately 37%
Guidance for the quarter ending June 30, 2003
The difference between the GAAP and adjusted guidance for the second
quarter of 2003 is approximately $5 million of net expenses associated with
the acquisition of MedImmune Vaccines.
* Earnings per diluted share:
-- Adjusted: $0.00 to $0.02
-- GAAP: $(0.01) to $0.01
* Total revenues: $95 million to $105 million
About MedImmune
MedImmune is a leading biotechnology company focused on researching,
developing and commercializing products to prevent or treat infectious
disease, autoimmune disease and cancer. MedImmune actively markets three
products, Synagis(R) (palivizumab), Ethyol(R) (amifostine) and CytoGam(R)
(cytomegalovirus immune globulin intravenous (human)), and has additional
products in clinical testing. MedImmune employs over 1,700 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 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 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 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(R) 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). FluMist(TM) is MedImmune's
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
May 22, 2003 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, Synagis; whether
FluMist receives clearance by the Food and Drug Administration and, if it
does, whether it will be successfully launched at a favorable price;
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, intellectual property or other
types of litigation; 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, 2002, its quarterly reports on Form 10-Q
and its current reports on Form 8-K 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 (including FluMist) 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. This press release contains certain
financial measures that are adjusted to exclude amounts required by GAAP, and
includes the most directly comparable GAAP measure for each adjusted measure,
as well as a reconciliation between the GAAP results and the adjusted results.
This press release can be found on MedImmune's website at
http://www.medimmune.com in the box marked "News" or with the archived press
releases on the Investor Summary page.
SOURCE MedImmune, Inc.
-0- 05/22/2003
/CONTACT: Investors: William Roberts, Senior Manager, Investor Relations,
+1-301-527-4358, or John Filler, Senior Analyst, Investor Relations,
+1-240-632-4086, or Media: Jamie Lacey, Associate Director, Public Relations,
+1-240-632-4035, all of MedImmune, Inc./
/Web site: http://www.medimmune.com/
(MEDI)
CO: MedImmune, Inc.
ST: Maryland
IN: BIO MTC
SU: ERP
CD-MV
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2791 05/22/2003 10:49 EDT http://www.prnewswire.com