First Quarter 2004 Highlights
* Total revenues increased 13 percent to $489 million
* Supplemental biological license application filed for liquid Synagis(R)
* Positive data announced for CAIV-T, human papillomavirus vaccine, PCDGF
and EphA2 programs
* Completed enrollment in two Phase 2 Vitaxin(R) trials
* Initiated Phase 1 RSV treatment trial for Numax(TM)
* $168 million in MedImmune Vaccines 5.25% convertible debt redeemed
GAITHERSBURG, Md., April 21 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that total revenues for the 2004 first quarter
grew 13 percent over the 2003 first quarter to $489 million. This growth was
primarily due to increased worldwide sales of Synagis (palivizumab) to
$422 million in the 2004 first quarter. Reported worldwide sales of Synagis
in the 2003 first quarter were $391 million, which reflected a favorable
adjustment of approximately $14 million due to lower sales allowances. Absent
this favorable adjustment, growth in Synagis in the 2004 quarter would have
been 12 percent over the 2003 first quarter.
In the 2004 first quarter, MedImmune also recognized $31 million in
revenues related to FluMist(TM) (Influenza Virus Vaccine Live, Intranasal),
including transfer payments, royalties and reimbursements from Wyeth, the
company's co-promotion partner for the vaccine. As discussed in MedImmune's
March 1, 2004 guidance press release, discussions are ongoing with Wyeth
regarding their continued role, if any, in the development and
commercialization of FluMist. Further information will be provided when
discussions are concluded.
"During the first quarter of 2004, MedImmune made substantial progress on
a number of fronts," stated David M. Mott, president and chief executive
officer. "Net earnings were strong due to double-digit growth in revenues,
while several key clinical programs made solid progress. We completed
enrollment in two of our four Phase 2 clinical trials for Vitaxin; we
initiated a treatment study with Numax; we announced encouraging data from two
Phase 3 trials with CAIV-T; and our partners at GlaxoSmithKline presented
positive Phase 2 results for our joint human papillomavirus vaccine program.
We look forward to continuing to make progress on both the commercial and
development fronts throughout 2004."
MedImmune's net earnings for the 2004 first quarter were $111 million, or
$0.44 per diluted share, compared to net earnings of $110 million, or
$0.43 per diluted share in the 2003 first quarter.
Gross margins on product sales for the 2004 first quarter were 67 percent,
down nine percentage points from last year, largely due to the impact of
2003/2004 FluMist seasonal sales and cost of sales recognized in the first
quarter of 2004. Gross margins for the 2004 first quarter were also adversely
impacted by the write-down of the 2004/2005 FluMist seasonal inventory
produced in the first quarter 2004.
Research and development (R&D) expenses increased to $50 million in the
2004 first quarter from $32 million in the 2003 first quarter largely due to
increased expenses from ongoing and additional clinical and preclinical trials
for product candidates, including Vitaxin, Numax, FluMist and CAIV-T.
Selling, general and administrative (SG&A) costs in the 2004 first quarter
increased to $124 million from $115 million in the comparable 2003 period, due
primarily to increased legal costs and higher marketing and promotion
expenses, principally for Synagis.
Other operating expenses declined to $2 million in the 2004 first quarter.
In the 2003 first quarter, other operating expenses totaled $21 million and
included the costs for manufacturing FluMist prior to the vaccine's approval
in June 2003.
Cash and marketable securities at March 31, 2004 were $2.0 billion, up
from $1.9 billion at December 31, 2003, primarily due to cash flow from the
company's ongoing business operations, partially offset by the March 31, 2004
redemption of the outstanding $168 million principal amount of MedImmune
Vaccines' 5.25% convertible debentures due 2008.
2004 Guidance
As a convenience to investors, MedImmune provides guidance and objectives,
all of which 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.
For the year ending December 31, 2004, MedImmune's guidance remains
consistent with that discussed in the guidance press release issued on March
1, 2004. For the second quarter, 2004, MedImmune projects its revenues to be
in the range from $93 million to $98 million, and the loss per share for the
quarter is projected to range from $0.13 to $0.16. As a reminder, MedImmune's
quarterly results are significantly impacted by the seasonality of its
marketed products, primarily that of Synagis and FluMist, which are used to
prevent respiratory viruses that are prevalent during the winter months.
Conference Call & Webcast
MedImmune is offering a live webcast of a discussion by MedImmune
management of its earnings and other business results on Wednesday, April 21,
2004 at 8:00 a.m. eastern time. The live webcast may be accessed in the
investor section of MedImmune's website, www.medimmune.com. A replay of the
webcast will also be available via our website until April 28, 2004. An audio
replay of the webcast will be available, beginning at 10:00 a.m. eastern time
on April 21, 2004 and ending at midnight on April 28, 2004 by calling (888)
286-8010. The passcode for the audio replay is 80538634.
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 four
products, Synagis(R) (palivizumab), Ethyol(R) (amifostine), FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal), and CytoGam(R) (cytomegalovirus
immune globulin intravenous (human)), and has additional products in clinical
testing. MedImmune employs approximately 1,800 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 and its products, visit the company's
website at www.medimmune.com.
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. 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 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 gland. FluMist is marketed for active
immunization for the prevention of disease caused by influenza A and B viruses
in healthy children and adolescents, 5-17 years of age, and healthy adults,
18-49 years of age. CytoGam is marketed for the prophylaxis against
cytomegalovirus disease associated with transplantation of kidney, lung,
liver, pancreas, and heart. For full prescribing information of all of
MedImmune's products, see the company's website at www.medimmune.com.
DISCLOSURE NOTICE: The information contained in this document is as of
March 31, 2004 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 supply of Synagis and FluMist; the commercial viability of
FluMist; 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 and interest 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, 2003, its quarterly
reports on Form 10-Q, its current reports on Form 8-K and other filings with
the U.S. Securities and Exchange Commission. MedImmune cautions that RSV
disease and influenza occur 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. 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.
MedImmune, Inc.
Consolidated Statements of Operations (Unaudited) (1)
(in thousands, except per share data)
Three Months Ended March 31,
2004 2003
Revenues:
Product sales $483,209 $431,109
Other revenue 5,792 3,511
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
333,507 271,711
Interest income, net 14,507 11,191
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 computing
basic earnings per share 248,180 251,499
Diluted earnings per share $0.44 $0.43
Shares used in computing
diluted earnings per share 250,896 256,514
(1) Certain prior year amounts have been reclassified to conform to the
current presentation.
MedImmune, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
March 31, December 31,
2004 2003
(unaudited)
Assets:
Cash and marketable securities $1,958,790 $1,900,149
Trade and contract receivables, net 156,170 166,220
Inventory, net 59,308 91,703
Deferred taxes, net 129,660 180,602
Property and equipment, net 281,657 273,597
Goodwill and intangible assets, net 106,206 110,308
Other assets 68,582 72,091
$2,760,373 $2,794,670
Liabilities and shareholders' equity:
Accounts payable $19,342 $22,116
Accrued expenses 354,451 299,843
Advance from Wyeth 24,401 51,910
Other liabilities 34,587 39,507
Long term debt 507,770 682,076
Shareholders' equity 1,819,822 1,699,218
$2,760,373 $2,794,670
Common shares outstanding 248,258 248,036
SOURCE MedImmune, Inc.
-0- 04/21/2004
/CONTACT: Investors: John Filler, +1-301-398-4086, or Media: Jamie Lacey,
+1-301-398-4035, both of MedImmune, Inc./
/Web site: http://www.medimmune.com /
(MEDI)
CO: MedImmune, Inc.
ST: Maryland
IN: MTC HEA BIO
SU: ERN CCA
KC
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9031 04/21/2004 07:03 EDT http://www.prnewswire.com