GAITHERSBURG, Md., Oct 24, 2002 /PRNewswire-FirstCall via COMTEX/ --Highlights for the 2002 Third Quarter and First Nine Months * Total revenues increase 53 percent in quarter and 43 percent year-to-date * Worldwide Synagis(R) (palivizumab) sales were $30 million in the quarter; sales in the nine-month period up 33 percent * Ethyol(R) (amifostine) sales reach $20 million for quarter and $55 million year-to-date * Response to FluMist(TM) Second Complete Response Letter submitted to FDA in August * Rights to newly discovered respiratory virus in-licensed
MedImmune,
Inc. (Nasdaq: MEDI) today announced that total revenues increased 53 percent to
$73 million in the 2002 third quarter and 43 percent to $466 million in the
first nine months of the year. Worldwide sales of Synagis, the company's
flagship product used to prevent respiratory syncytial virus (RSV) in high-risk
infants, contributed $30 million to revenues in the third quarter and $356
million in the nine-month period. Sales of Synagis are seasonal and occur
primarily in the fourth and first quarters of the year, coinciding with the
prevalence of RSV in the Northern Hemisphere during the winter months. Sales of
Ethyol, the company's first oncology product, reached $20 million in the quarter
and $55 million through the first nine months of 2002. Demand for Ethyol has
continued to trend steadily upwards since MedImmune reacquired all U.S. rights
of the product on October 1, 2001.
"We continue to make great progress in all areas of the business," commented
David Mott, MedImmune's chief executive officer. "Our sales forces have done a
tremendous job throughout 2002 at increasing sales of Synagis and Ethyol. During
the third quarter, we took another step in becoming the industry leader in
respiratory infectious diseases when we acquired the worldwide rights to a newly
discovered respiratory virus and submitted our response to the FDA's second
Complete Response Letter for FluMist. Last week we announced successful results
from a Phase 3 study for Synagis in congenital heart disease patients, which we
hope will help continue to expand the usefulness of Synagis, particularly in
Europe, in preventing RSV-related hospitalizations in high-risk children."
MedImmune reported a net loss of $36 million, or $0.14 per share, for the 2002
third quarter and a net loss of $1.2 billion, or $4.75 per share, for the first
nine months of 2002. The losses reflect the impact of a $1.2 billion in-process
research and development charge associated with the purchase of Aviron (now
known as MedImmune Vaccines). FluMist, which is a nasally delivered flu vaccine
currently under FDA review, was acquired as a part of the merger with Aviron on
January 10, 2002. In 2001, MedImmune reported a net loss of $19 million, or
$0.09 per share, for the third quarter, and net income of $50 million, or $0.23
per diluted share, for the nine-month period.
MedImmune also announced "adjusted" results for 2002, which exclude certain
amounts associated with the acquisition of MedImmune Vaccines. MedImmmune
computes "adjusted" earnings by adding back amounts that are related to the
acquisition of Aviron, including: the in-process research and development
charge; amortization of intangible assets; compensation expense associated with
the assumption and acceleration of unvested stock options, retention and
severance payments; and amortization of premium on convertible subordinated
notes. The amounts for both the quarter and nine-month period are detailed in
the notes to the accompanying consolidated statement of operations. MedImmune
believes the "adjusted" results are more indicative of the underlying trends in
the operations of the business, and will continue to provide "adjusted" results
in addition to reporting earnings in accordance with generally accepted
accounting principles (GAAP).
Third Quarter Adjusted Results
For the 2002 third quarter, MedImmune's adjusted losses were $32 million, or
$0.13 per share.
Gross margins for the 2002 third quarter were 62 percent, up three percentage
points over the 2001 quarter. This increase is largely due to the impact of an
inventory write-off in the 2001 quarter, partially offset by additional royalty
payments in 2002 related to domestic Synagis sales.
Research and development expenses rose to $31 million in the 2002 third quarter
from $21 million last year. The increases, due largely to the inclusion of
MedImmune Vaccines' on-going activities and the cost of in- licensing the human
metapneumovirus technology, were partially offset by reduced spending in other
areas of research and development.
Selling, general and administrative costs in the third quarter of 2002 increased
to $48 million from $44 million in the 2001 period, due primarily to the
acquisition of MedImmune Vaccines, higher marketing expenses for Synagis and
Ethyol, and the cost associated with settling a contractual dispute. The
comparison to last year is affected by a charge in the 2001 third quarter for
termination payments associated with the return of marketing rights for Ethyol.
Other operating expenses in the third quarter of 2002 were $21 million compared
to $2 million in the third quarter last year, primarily due to costs associated
with the manufacture of FluMist.
Results for the quarter also reflect approximately $11 million in impairment
losses on certain equity investments that have been affected by the downward
movement in the capital markets.
Nine Month Adjusted Results
MedImmune's adjusted earnings for the first nine months of 2002 were $14
million, or $0.06 per diluted share.
Gross margins for the nine-month period in 2002 were 73 percent, down two
percentage points from the comparable period last year, largely due to
additional royalty payments in 2002 related to domestic Synagis sales.
Research and development expenses rose to $105 million in the 2002 period from
$62 million in the 2001 period, largely due to the inclusion of MedImmune
Vaccines' on-going activities, the cost of in-licensing the human
metapneumovirus technology, and the progress of the research pipeline over the
course of 2002.
Selling, general and administrative costs in the 2002 nine-month period
increased to $186 million from $128 million in the 2001 period due primarily to:
the acquisition of MedImmune Vaccines; higher sales and marketing expenses for
Synagis and Ethyol; increases in infrastructure costs to support the growth of
the business; and costs associated with the settlement of a contractual dispute.
Other operating expenses in the 2002 nine-month period were $54 million compared
to $8 million in the 2001 period, primarily due to costs associated with the
manufacture of FluMist.
Cash and marketable securities at September 30, 2002 were $1.2 billion compared
to $778 million at December 31, 2001, primarily reflecting cash and securities
received as a part of the acquisition of Aviron and positive cash flow from
operations.
Looking Ahead in 2002
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 calendar quarters when RSV is most prevalent in the
Northern Hemisphere. Results for the second and third quarters will reflect this
seasonality. The guidance and objectives provided below are projections and
assume the continued growth and success of MedImmune's existing business,
including sales of Synagis and Ethyol. Further, the guidance provided below
assumes FluMist will be approved in the U.S. during 2003. FluMist was acquired
as a part of MedImmune's acquisition of Aviron, a formerly public company whose
2001 financial results were filed on July 10, 2002 with the U.S. Securities and
Exchange Commission through an 8-K submission. The projections provided here 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 for the quarter ending December 31, 2002:
* Total revenues: approximately $350 million
* Adjusted diluted earnings per share: $0.31 to $0.33
* GAAP earnings per share: $0.30 to $0.32
Webcast
MedImmune is offering a live webcast of a discussion by MedImmune management of
its earnings and other business results on Thursday, October 24, 2002 at 8:00
a.m. ET. 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 October 31, 2002. An audio replay of the webcast will be
available beginning at 11:00 a.m. ET on October 24, 2002 until midnight October
31, 2002 by calling 719-457-0820. The pass code for the audio replay is 613119.
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 11 products in clinical testing.
MedImmune employs approximately 1,600 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 October
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, Synagis; whether FluMist receives clearance by
the Food and Drug Administration and, if it does, whether it will be
successfully launched; 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, 2001 and
in its periodic reports on Forms 10-Q and 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.
MedImmune, Inc.
Condensed Consolidated Statement of Operations (Unaudited)(1)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2002 2001 2002 2001
Revenues:
Product sales $59,233 $39,991 $437,231 $303,508
Other revenue 13,401 7,419 28,758 22,468
72,634 47,410 465,989 325,976
Costs and expenses:
Cost of sales 22,296 16,340 117,815 76,270
Research and
development 31,822(2) 21,224 110,436(2) 61,616
Selling, general and
administrative 51,197(3) 44,228 194,191(3) 128,170
Other operating
expenses 24,118(4) 2,074 68,111(4) 7,669
Acquired in-process
research and
development - - 1,179,321(6) -
129,433 83,866 1,669,874 273,725
Interest income, net 10,949(5) 9,038 30,217(5) 27,971
Loss on investment
activities (10,557) - (10,666) -
(Loss) earnings before
income taxes (56,407) (27,418) (1,184,334) 80,222
(Benefit) provision
for income taxes (20,115) (8,444) (1,728) 29,768
Net (loss) earnings $(36,292) $(18,974) $(1,182,606) $50,454
Basic (loss) earnings
per share $(0.14) $(0.09) $(4.75) $0.24
Shares used in
computing basic
(loss) earnings
per share 250,830 213,876 249,080 213,075
Diluted (loss)
earnings per share $(0.14) $(0.09) $(4.75) $0.23
Shares used in
computing diluted
(loss) earnings
per share 250,830 213,876 249,080 219,864
Notes:
(1) As of January 10, 2002, the company has included the results of
operations for MedImmune Vaccines, Inc., formerly Aviron, which was
acquired through an exchange offer and merger transaction valued at
$1.6 billion.
(2) Includes acquisition-related amounts of $1.1 million for the three
months and $3.9 million for the nine months, principally for stock
compensation expense for unvested stock options assumed in conjunction
with the merger transaction. For the nine months, an additional $1.8
million is included relating to retention payments and stock
compensation expense for acceleration of stock options for certain
executives of the acquired entity, bringing the total for nine months
to $5.7 million.
(3) Includes acquisition-related amounts of $2.7 million for the three
months and $8.6 million for the nine months, principally for
amortization of intangible assets and stock compensation expense for
unvested stock options assumed in conjunction with the merger
transaction.
(4) Includes acquisition-related amounts of $3.4 million for the three
months and $10.4 million for the nine months, principally for
amortization of intangible assets and stock compensation expense for
unvested stock options assumed in conjunction with the merger
transaction. For the nine months, an additional $4.0 million is
included relating to retention payments and stock compensation expense
for acceleration of stock options for certain executives of the
acquired entity, bringing the total for nine months to $14.4 million.
(5) Includes acquisition-related amounts of $0.5 million for the three
months and $1.4 million for the nine months related to the
amortization of the premium on MedImmune Vaccine's Convertible
Subordinated Notes.
(6) Represents the fair value of purchased in-process technology of $1.2
billion, primarily related to MedImmune Vaccine's lead product
candidate, FluMist, which has not been approved by the FDA.
MedImmune, Inc.
Selected Financial Information Excluding Certain
Acquisition-Related Amounts(1)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2002 2001 2002 2001
Revenues:
Product sales $59,233 $39,991 $437,231 $303,508
Other revenue 13,401 7,419 28,758 22,468
72,634 47,410 465,989 325,976
Costs and expenses:
Cost of sales 22,296 16,340 117,815 76,270
Research and
development 30,730 21,224 104,780 61,616
Selling, general and
administrative 48,468 44,228 185,559 128,170
Other operating
expenses 20,687 2,074 53,662 7,669
Acquired in-process
research and
development - - - -
122,181 83,866 461,816 273,725
Interest income, net 10,483 9,038 28,865 27,971
Loss on investment
activities (10,557) - (10,666) -
(Loss) earnings before
income taxes (49,621) (27,418) 22,372 80,222
(Benefit) provision
for income taxes (17,793) (8,444) 7,948 29,768
Net (loss) earnings $(31,828) $(18,974) $14,424 $50,454
Basic (loss) earnings
per share $(0.13) $(0.09) $0.06 $0.24
Shares used in
computing basic
(loss) earnings
per share 250,830 213,876 249,080 213,075
Diluted (loss)
earnings per share $(0.13) $(0.09) $0.06 $0.23
Shares used in
computing diluted
(loss) earnings per
share 250,830 213,876 251,711 219,864
Note:
(1) As of January 10, 2002, the company has included the results of
operations for MedImmune Vaccines, Inc., formerly Aviron, which was
acquired through an exchange offer and merger transaction valued at
$1.6 billion. Certain acquisition-related amounts, as detailed in the
Notes to the Condensed Consolidated Statement of Operations, have been
excluded for purposes of this presentation.
MedImmune, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
September 30, December 31,
2002 2001(1)
unaudited
Assets:
Cash and marketable securities $1,233,758 $777,690
Trade and contract receivables, net 43,722 127,960
Inventory, net 53,304 52,691
Deferred taxes, net 303,791 163,641
Property and equipment, net 167,161 95,402
Goodwill and intangible assets, net 132,432 -
Other assets 13,229 19,471
$1,947,397 $1,236,855
Liabilities and shareholders' equity:
Accounts payable $7,675 $5,873
Accrued expenses 99,474 160,154
Other liabilities 41,380 17,011
Long term debt 222,859 9,544
Shareholders' equity 1,576,009 1,044,273
$1,947,397 $1,236,855
Common shares outstanding 250,924 214,484
Note:
(1) Certain prior year amounts have been reclassified to conform with
current year presentation.
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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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