MEDIMMUNE PLANS TO ACHIEVE $2 BILLION IN REVENUES BY
2009.
MedImmune, Inc. (NASDAQ:MEDI), Gaithersburg, Md., expects to
achieve $2 billion in total revenues by 2009, driven by investments in
its pipeline and the continued growth of its currently marketed
products.
MedImmune has announced results from two Phase 3 studies showing
that the refrigerator-stable formulation of FluMist(TM) (Influenza Virus
Vaccine Live, Intranasal) was statistically significantly more effective
than the injectable influenza vaccine in preventing culture-confirmed
influenza. These data reaffirmed MedImmune's commitment to
developing and commercializing FluMist. If successful, MedImmune expects
peak annual FluMist sales in excess of $500 million in the U.S. and
approximately $800 million worldwide.
David M. Mott, MedImmune's president and chief executive
officer, stated, "We are encouraged by the initial results from
Phase 3 clinical trials with the refrigerator-stable version of FluMist
and excited by its potential to substantially improve public health. We
are equally excited about the surge in productivity in the rest of our
pipeline, which we expect will result in having four Phase 3 programs
underway in 2005 and the addition of three new clinical targets per year
for the next three years. These R&D investments over the next few
years are expected to drive significant long-term revenue and earnings
growth for our shareholders."
As the company implements its five-year plan, MedImmune projects
full-year 2004 earnings per share (EPS) to range from $0.50 to $0.60, as
the company accelerates its investment in research and development
(R&D) to approximately 20 percent of product sales. MedImmune
projects that it will nearly double EPS to a range of $1.00 to $1.10 by
2007 and achieve a compounded annual growth rate (CAGR) in EPS of 25
percent to 30 percent for the 2004 through 2009 period.
Revenues
MedImmune forecasts 2004 total revenues to range from $1.12 billion
to $1.16 billion, driven primarily by product sales growing at a low
double-digit growth rate. MedImmune projects total revenues will reach
approximately $1.5 billion in 2007 and approximately $2 billion by 2009.
-- The primary contributor to revenue in 2004 will be sales of
MedImmune's flagship product, Synagis(R) (palivizumab). MedImmune
projects worldwide Synagis revenues to grow by approximately 10 percent
in 2004 and to reach $1 billion in 2005. By 2009, MedImmune projects
that the five-year revenue CAGR for Synagis will be in the mid-to-high
single- digits.
-- MedImmune forecasts worldwide Ethyol(R) (amifostine) revenues to
increase approximately 10 percent in 2004, and to generate a five-year
CAGR in the low double-digits for the period ending in 2009.
Expenses
The primary driver behind MedImmune's increased commitment to
R&D is its intention to continue developing FluMist and its plan to
introduce at least two new products between 2007 and 2009. To achieve
this objective, MedImmune expects to have four products in Phase 3
clinical trials in 2005 and to file three new Investigational New Drug
(IND) applications per year in each of 2004, 2005 and 2006. In 2003, the
company filed INDs for Numax(TM), a potential next-generation antibody
targeting respiratory syncytial virus; an anti-IL-9 antibody targeting
asthma; and siplizumab, an antibody targeting CD2 for T-cell lymphoma.
In 2004, MedImmune also expects Selling, General &
Administrative expenses to be approximately 36 percent of product sales,
gross margins to be in the range of 67 percent to 68 percent, and its
tax rate to be approximately 37 percent.
FluMist(TM) Update
MedImmune maintains its belief that FluMist is a significant
advance in the prevention of influenza disease. Notwithstanding its
commitment to the future of FluMist, MedImmune does not expect the
vaccine to be a meaningful contributor to revenue growth before 2007,
when the company hopes to launch the refrigerator-stable version of
FluMist (CAIV-T) in the United States. In 2004, FluMist-related revenue
is currently forecast to be in the range of $45 to $55 million,
including revenues related to vaccine sold for the 2003/2004 influenza
season. From 2004 to 2006, MedImmune expects to focus its efforts on
developing FluMist into a superior influenza vaccine preferred by
pediatricians, with particular attention toward developing CAIV-T (now
in Phase 3 development) and extending the indicated population to
include individuals below the age of five years and above the age of 49
years.
Discussions remain ongoing with Wyeth, MedImmune's partner for
FluMist, regarding the commercial and product development plan for the
vaccine. No final decisions have been made regarding price, production
or Wyeth's role for 2004 and beyond. Under the current agreements,
Wyeth's co-development and co- promotion rights in the U.S. revert
to MedImmune in approximately ten years, and outside the U.S.,
Wyeth's rights revert to MedImmune in the future as well. Should
Wyeth exit the partnership earlier than as described under the current
agreements, MedImmune would write-off approximately $75 million in
unamortized intangibles associated with the Wyeth agreements, as well as
assume responsibility for all future investment. Excluding the one-time
write-off, MedImmune projects Wyeth's exit from the partnership
would decrease EPS by $0.10 to $.20 annually through 2007, but increase
EPS by up to $0.20 by 2009.
FluMist - Phase 3 Clinical Trial Results
Wyeth has completed preliminary analyses of two Phase 3 trials
comparing the refrigerator-stable formulation of FluMist to the
injectable influenza vaccine (TIV). In each trial, CAIV-T showed
statistically significant superior efficacy over TIV against culture
confirmed influenza with no statistically significant increase in
wheezing episodes.
The first trial, referred to as Study 514, included approximately
2,200 infants and children from six months through 71 months of age with
a history of recurrent respiratory infections. Children receiving CAIV-T
in this study had a 53-percent lower incidence of culture-confirmed
influenza than those receiving TIV. The second trial, referred to as
Study 515, included approximately 2,200 children from six years through
17 years of age with a history of asthma. Children receiving CAIV-T in
this study had a 35-percent lower incidence of culture-confirmed
influenza than those receiving TIV. Further analysis of the preliminary
results from both of these studies will be completed over the next
several months and prepared for presentation at appropriate medical
venues, as well as for submission to U.S. and foreign regulatory
authorities.
Additional Guidance
-- MedImmune enjoys a strong financial position with approximately
$1.9 billion in cash and marketable securities on the balance sheet at
year-end 2003 and expects to continue to generate cash from operations
in the future.
-- MedImmune expects to invest approximately $100 million annually
in capital expenditures over the next few years as it completes
investments in a number of R&D, manufacturing and administrative
facilities.
-- In 2004, MedImmune expects to call the remaining $168 million in
principal of the Aviron 5.25% 2008 convertible debentures.
-- The company is reinitiating its share repurchase program and
currently has $270 million remaining from last year's $500 million
authorization with which to repurchase shares.
Guidance for 2004 First Quarter
For the first quarter of 2004, MedImmune projects revenues of $485
million to $510 million and earnings of $0.40 to $0.43 per diluted
share.
Note on Guidance Format
MedImmune's guidance is presented in accordance with generally
accepted accounting principles (GAAP). In 2002 and 2003, MedImmune
provided both GAAP and adjusted guidance, as well as reconciliation
between the two, as a convenience to its investors. MedImmune's
adjusted guidance in those years excluded certain amounts associated
with the acquisition of MedImmune Vaccines in 2002 to present the
results in the same manner as the company views the performance of its
business and the resulting underlying trends. In 2003, the full-year
difference between MedImmune's GAAP and adjusted results were $0.04
on a diluted earnings per share basis. Going forward, MedImmune
currently believes that its GAAP results will be comparable for
year-over-year comparisons and has discontinued the use of adjusted
guidance.
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, visit http://www.medimmune.com or call
301/527-4358.
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