Meeting Highlights
* Preparing to Launch FluMist(TM), the Company's Second Potential
Blockbuster Product
* Expecting to Surpass $1 Billion in Revenues for First Time in 2003
* Expanding Clinical Programs Focused on Infectious Diseases,
Cancer and Immunological Disorders
* Planning to File Eight New Investigational New Drug Applications
(INDS) in the Next Eight Quarters
* Enhancing Infrastructure and Systems to Support Product and Corporate
Growth
GAITHERSBURG, Md., June 27 /PRNewswire-FirstCall/ -- Highlighting recent
commercial and product development accomplishments, as well as its robust
research program, MedImmune, Inc. (Nasdaq: MEDI) today will provide analysts
and investors an overview of its opportunities for long-term growth at a
Business Review Meeting to be held in Gaithersburg, Maryland. Senior
MedImmune executives will describe the future potential of the company's key
products; the strength of its pipeline; and the launch plans for FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal), MedImmune's recently approved
intranasal flu vaccine. In conjunction with the meeting, the company is
reconfirming its full-year guidance and increasing its guidance for the second
quarter.
David M. Mott, MedImmune's chief executive officer, said, "Today,
MedImmune is at the beginning of its next major growth cycle. We are enjoying
fantastic revenue growth, primarily due to our fifth consecutive, record-
setting season for Synagis(R) (palivizumab) with over $734 million in
worldwide sales reported for the 2002-2003 RSV season through the end of the
first quarter 2003. In the future, we expect FluMist(TM), which was approved
for marketing last week by the U.S. Food and Drug Administration (FDA), to
also help drive our revenue and earnings growth. Our commercial success is
paralleled by exciting developments in our well-diversified pipeline of future
product candidates."
MedImmune announced that it expects its key drivers to continue to deliver
strong revenues and earnings growth, maintaining its record of success
exemplified by a 30-percent, three-year compounded annual growth rate for
revenues for 1999-2002. In 2003, the company expects to surpass $1 billion in
revenues for the first time and to set record earnings in the range of $0.88
to $0.93 per diluted share on an adjusted basis. The company's 2003 earnings
guidance in accordance with generally accepted accounting principles (GAAP) is
$0.84 to $0.89 per diluted share, also a record.
MedImmune expects to advance several important clinical programs targeting
diseases that currently have poor, if any, medical options, while moving eight
new preclinical projects into clinical trials over the next eight quarters.
In 2003, MedImmune's goals include:
* adding four new targets to its research portfolio;
* moving two molecules into clinical testing, Numax(TM), a second
generation anti-RSV monoclonal antibody (MAb) and an antibody targeting
IL-9 (Interleukin-9) for application in asthma;
* initiating several Phase 2 trials with Vitaxin(TM), a MAb with anti-
angiogenic properties that has applications in both cancer and
immunology;
* supporting the preparations for initiating Phase 3 clinical studies for
its human papillomavirus (HPV) vaccine to prevent cervical cancer; and,
* filing a supplement to its Biological License Application (BLA) with the
FDA for potential manufacture of liquid Synagis.
MedImmune also looks forward to receiving the FDA's response to Phase 3
data supporting the use of Synagis in infants with congenital heart disease,
which the company submitted to the agency in December 2002.
Key Growth Drivers
MedImmune's key growth drivers for near-term revenues include Synagis,
FluMist and Ethyol.
Synagis
"Synagis is now the standard of care for prevention of a serious lower
respiratory tract disease caused by respiratory syncytial virus (RSV) in high-
risk infants," said Melvin D. Booth, MedImmune president and chief operating
officer. "From 2001 to 2002, we experienced a 29-percent increase in year-
over-year sales. We expect strong growth to continue with 20 to 24 percent
year-over-year sales growth in 2003."
Synagis has experienced continued growth based on its solid safety profile
and proven efficacy. Further opportunity for the product may come from
increased use in infants born with congenital heart disease, expanded
awareness among family practitioners, and broader international sales. In
addition, in the second half of 2003, MedImmune plans to submit to the FDA a
supplement to its BLA for a liquid formulation of Synagis, a product
improvement option that could simplify its use in physicians' offices and
clinics.
FluMist
FluMist was granted marketing approval by the FDA on June 17, 2003 as the
first influenza vaccine delivered as a nasal mist available in the United
States for healthy people.
"Everyone is susceptible to the flu," said Armando Anido, R.Ph.,
MedImmune's senior vice president, sales and marketing. "Initially, we will
educate consumers on the burden of this illness as we seek to provide broad
access to the product through doctors' offices, pharmacies and workplaces."
MedImmune and its marketing partner, Wyeth Vaccines, will target the use of
FluMist for school-aged children, adults in frequent contact with children,
and health-minded working adults. The initial potential target population for
the product as indicated includes the 160 million healthy Americans between
the ages of 5 and 49.
FluMist will be available in many physicians' offices and pharmacies in
time for this flu season. MedImmune expects to manufacture four million to
six million doses of FluMist for this inaugural season. From sales, royalties
and milestone payments, MedImmune expects to generate $120 million to $140
million in revenues from FluMist in 2003.
Ethyol
Ethyol, the company's first marketed oncology product, is used to reduce
selected toxic side effects of certain chemotherapy and radiation therapy when
used to treat cancers of the lung, ovary or head and neck. Since MedImmune
acquired 100 percent of the U.S. marketing rights from Alza Corp. in October
2001, sales have resurged and shown a strong year-over-year growth for the
last several quarters. In the first quarter of 2003, Ethyol sales increased
49 percent to $27 million.
MedImmune hopes to continue to drive acceptance of Ethyol in the future by
conducting clinical studies that have the potential to expand the product's
current label. In mid-2003, MedImmune plans to start a Phase 2 study with
Ethyol to evaluate the potential to reduce radiation-induced pneumonitis and
esophagitis in non-small cell lung cancer patients undergoing radiation
therapy. This study will include subcutaneous administration of Ethyol, which
if successful, may improve the product's ease-of-use in the radiation
oncologist's office.
Advancing Clinical Programs in Infectious Disease, Cancer and Immunology
MedImmune is advancing a number of potentially medically important
clinical programs, including those for Vitaxin, HPV vaccine, Numax, and an
antibody targeting IL-9.
Vitaxin
Edward M. Connor, M.D., MedImmune's senior vice president, clinical
development, said, "Vitaxin is one of our most interesting molecules in
clinical development today because of its mechanism of action targeting
alpha-V beta-3, a protein implicated in angiogenesis, the growth and
metastasis of tumors, as well as in the damage done to bone in rheumatoid
arthritis (RA). We currently believe that if Vitaxin can be successfully
developed to block alpha-V beta-3, it might also be instrumental in inhibiting
the advancement of these devastating and life-threatening diseases."
MedImmune intends to begin a number of Phase 2 studies in the second half
of 2003, including one study in patients with moderate-to-severe RA, and two
oncology studies in melanoma and prostate cancer patients. Data from the
company's recently completed Phase 1 RA study may be presented at the World
Congress on Inflammation this August.
HPV Vaccine
Encouraging Phase 2 data for MedImmune's HPV vaccine were presented by
MedImmune's partner for this project, GlaxoSmithKline (GSK), on April 14,
2003, at the EUROGIN Meeting in Paris. The presented data showed that the
vaccine was 100-percent effective in preventing persistent HPV infection in
patients receiving three doses within the protocol. HPV is often associated
with cervical cancer, the second most common cancer in women with 437,000
cases each year and 200,000 deaths annually worldwide. The company expects
GSK to move the HPV vaccine into Phase 3 clinical trials within the next year.
Numax
"Following through on our commitment to continually improve upon our
existing products," said Dr. Connor, "we plan to file an IND in the third
quarter for Numax, our next generation anti-RSV antibody. This new and
potentially more potent RSV antibody may, if successfully developed, allow us
to improve efficacy, reduce dosing, or expand into additional indications."
To date, preclinical studies have demonstrated an enhanced potency profile
for Numax, relative to Synagis, with more than twenty-fold improvements in
neutralizing RSV in tissue culture and a reduction of RSV in the lungs of
cotton rats.
Anti-IL-9 MAb
"We intend to file an IND later this year for a stand alone antibody
therapy for the prevention of asthma exacerbations," said Dr. Connor. "Moving
into the asthma disease area is a natural progression for MedImmune, a leader
in the development of antibodies for respiratory disease."
MedImmune's anti-IL-9 MAb targets a key inflammatory-cell molecule that is
overexpressed during human asthmatic response. MedImmune believes that
antibodies against IL-9 may help decrease asthma reactions in the airway and
lungs.
Expanding Research and Development Activities
MedImmune's stated research goal is to add four new research targets each
year. To accomplish this, MedImmune relies on in-house discovery capabilities
and carefully selected in-licensing agreements that provide access to new
science and technologies. During the meeting James F. Young, Ph.D.,
president, research and development, will highlight a number of the company's
current research activities, including MedImmune's recent in-licensing of
MT103 from Micromet AG.
* MT103 is a Bi-Specific T-Cell Engager (BiTE) targeting the CD19 protein
found on B cells. Micromet has initiated two European Phase 1 studies
of MT103 in non-Hodgkin's lymphoma (NHL) and plans to initiate a Phase 1
study in chronic lymphocytic leukemia (CLL) later this year. MedImmune
will be responsible for all clinical development within the U.S.,
including the early stage clinical trials scheduled to begin in 2004.
* EphA2 is a protein overexpressed on number of aggressive tumors,
including breast, colon, prostate, lung and skin cancers. Data
published in Cancer Research indicate that antibodies designed to
interact with EphA2 could be used to both regulate tumor cell growth and
prevent metastasis, while sparing normal cells. MedImmune is currently
investigating multiple monoclonal antibodies from which it plans to
select a lead molecule in the second half of 2003, possibly leading to
an IND filing in the first half of 2004.
* PCDGF is a secreted growth factor overexpressed in breast, ovarian
carcinomas, renal cell carcinoma, and multiple myeloma. MedImmune has
several candidate MAbs and is attempting to identify PCDGF receptors on
tumor cells, with the potential filing of an IND in the second half of
2004.
* HAAH is the enzyme Human Aspartyl (Asparaginyl) Beta-Hydroxylase, which
is overexpressed on the cell surface of a wide variety of tumors.
MedImmune is moving forward with testing the efficacy of anti-HAAH MAbs
in mice.
* Human metapneumovirus (hMPV) is a newly described virus causing a
significant percentage of respiratory infections in children worldwide.
The company acquired exclusive worldwide rights to antibodies and
vaccines targeting hMPV in 2002.
* Vaccines targeting RSV, parainfluenza virus type-3 (PIV-3) and hMPV are
in preclinical development using a bovine PIV-3 vector. MedImmune has
identified vaccine candidates for all three viruses using this
technology and is evaluating the potential to create one vaccine that
will prevent two or more of these respiratory viruses. The company
anticipates that it will be in a position to file an IND for such
vaccines in the first half of 2004.
Commenting specifically on hMPV, Dr. Young said: "Through our research of
hMPV, we plan to work toward development of both antibodies and vaccines.
Recognizing that hMPV is in some ways similar to RSV, we may seek to create a
combination therapy or vaccine that will prevent both viruses, thereby
potentially reducing the incidence of these common respiratory infections in
children."
Investing in the Infrastructure
MedImmune continues to invest in its future, not only through advancing
and expanding its pipeline, but by increasing the capacity of many aspects of
its infrastructure. Commenting on this, Mr. Booth said, "Throughout the last
12 months, we have invested in all of the pieces within our operational
infrastructure -- from sales and marketing to manufacturing to our facilities
and systems.
"During the meeting, Mr. Booth will highlight the company's commitment to
world-class manufacturing operations, citing process improvements at the
Synagis manufacturing center in Frederick, Maryland. Recently, the company
implemented an enhanced yield process (EYP) for Synagis that more than triples
the protein production, leading to increased efficiencies and reduced
manufacturing costs.
Mr. Booth will also underline the company's commitment to future core
corporate growth exhibited by the company's capital projects currently
underway, including the construction of the new state-of-the-art research
facility in Gaithersburg, Maryland; the bulk production facility for FluMist
in the United Kingdom; and the blend and fill facility for FluMist in
Pennsylvania.
Increasing Guidance for Second Quarter; Reconfirming Full Year Guidance
MedImmune's financial guidance includes guidance in accordance with GAAP
and adjusted guidance, as well as 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
MedImmune is reconfirming its full year guidance for 2003, which was
previously stated at the company's Annual Shareholder's Meeting on May 22,
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 revenues: 20% to 24% over 2002
- Ethyol revenues: 20% to 25% over 2002
- Total FluMist revenues (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 2002 loss of
$4.40 per share)
* 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
MedImmune is increasing its guidance for the second quarter of 2003 due to
stronger product sales and the timing associated with initiating certain
research and development programs. 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: $0.02 to $0.05 (previously $0.00 to $0.02)
- GAAP: $0.01 to $0.04 (previously ($0.01) to $0.01)
* Total revenues: $110 million to $120 million (previously $95 million to
$105 million)
Business Review Meeting Webcast
MedImmune is offering a live webcast of its Business Review Meeting, which
will start today, Friday, June 27, 2003 at 10:00 a.m. Eastern Time. The live
webcast may be accessed from the home page and in the investor section of
MedImmune's website, www.medimmune.com. A replay of the webcast will also be
available via our website until July 11, 2003.
About MedImmune, Inc.
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), FluMist(TM) (Influenza Virus Vaccine Live,
Intranasal), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune
globulin intravenous (human)), and has additional products in clinical
testing. MedImmune employs approximately 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 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. FluMist is indicated 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.
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. 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
June 27, 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 supply of Synagis and 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 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 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
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- 06/27/2003
/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: MTC HEA
SU: CCA ERP
JV-MB
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