GAITHERSBURG, Md., Dec. 6 /PRNewswire-FirstCall/ -- Highlighting its
proven strengths in discovering, developing and commercializing multiple
innovative products in several disease categories, MedImmune, Inc.
(Nasdaq: MEDI) today will provide an overview of its opportunities for
long-term growth at its 2006 Analyst Day. MedImmune executives plan to discuss
the company's technological and scientific capabilities and goals focused on
driving the company's financial results in 2009 to approximately $2 billion in
revenue and $2.00 in earnings per diluted share (EPS), excluding share-based
compensation expense. At today's meeting, MedImmune is reconfirming its 2006
guidance of $1.3 billion in revenues and an EPS range of $0.17 to $0.22,
excluding share-based compensation expense. The event, which will run from
9:00 a.m. to 4:30 p.m. eastern time, will be webcast via the company's website
David M. Mott, chief executive officer and president, stated, "Having
completed a significant multi-year investment in every aspect of the business
-- from the commercial organization to operations to our robust pipeline -- we
are poised to return to a pattern of robust financial growth as we approach
the middle of our five-year plan. As an established leader in pediatric
respiratory diseases, MedImmune expects continued growth from its largest
currently marketed product, Synagis(R) (palivizumab), and is ready to
implement a first-rate launch of refrigerated FluMist(R) (Influenza Virus
Vaccine Live, Intranasal) in 2007 and of Numax(R) in 2008, assuming timely
approval by the U.S. Food & Drug Administration (FDA). We also expect
royalties from our human papillomavirus vaccine technology to drive
substantial growth over the next several years. Finally, we have a firm belief
in our potential to deliver innovative products to patients from the largest
pipeline in the company's history thanks to our world-class management team
and the dedication of our scientific, medical, manufacturing, commercial, and
* RSV Franchise: MedImmune is the industry leader in the development of
innovative pediatric products targeting RSV. With its currently
marketed Synagis, the potential future market introduction of Numax and
several other RSV-targeted products in development, the company
believes that its franchise is stronger than ever and related worldwide
sales are expected to grow by a compounded average rate of
approximately 10 percent from 2006 to 2009.
-- Synagis: During 2006, MedImmune made a number of changes and
enhancements to its U.S. sales and marketing organization focused on
improving effectiveness and efficiency. The company believes these
changes are driving improvements in the business. MedImmune's
distribution partner outside the U.S., Abbott International,
continues to make excellent progress building the worldwide Synagis
brand. For the 2006-2007 RSV season, worldwide sales of Synagis are
expected to grow by approximately 10 percent. As previously stated,
worldwide sales of Synagis in calendar year 2006 are expected to be
approximately even with calendar year 2005, reflecting a stronger
second half of 2006.
-- Numax: MedImmune will discuss the current data profile for Numax,
the company's next-generation anti-RSV MAb, including the recently
announced results of its pivotal Phase 3 clinical trial results in
which Numax was compared directly to Synagis. In this study, Numax
demonstrated a 26-percent relative reduction versus Synagis in RSV
hospitalizations among high risk infants showing non-inferiority of
Numax compared to Synagis. The trial also showed a 50-percent
relative reduction in the incidence of outpatient medically attended
lower respiratory infections caused by RSV.
"MedImmune believes that the current data profile for Numax
establishes the value of the product in advancing RSV prevention,"
commented Edward M. Connor, M.D., executive vice president and chief
medical officer. "The results from our head-to-head Phase 3 study
indicate that Numax may have the potential to further strengthen
MedImmune's RSV franchise by offering high-risk infants additional
protection against RSV disease."
* Influenza franchise: MedImmune will describe its current plans to
launch the refrigerated formulation of FluMist with an expanded label
in 2007. The company is currently waiting for the FDA to complete its
review of two previously submitted supplemental biologics license
applications (sBLAs) focused on: 1) allowing the company to manufacture
a more convenient formulation (moving from the current frozen
formulation to a refrigerated formulation), and 2) expanding the
approved usage from the current population of healthy individuals 5 to
49 years of age to include children as young as one year of age who do
not have a history of wheezing or asthma.
"We are actively preparing for our launch of our new live, attenuated,
thimerosal-free intranasal vaccine," said Mark Twyman, vice president
and general manager, vaccines. "Our immediate goal is to help reduce
the serious burden of influenza disease among school-aged children with
a well-tolerated and effective vaccine that is also less painful to
receive than the traditional shot. Beyond that, we are confident in
future growth opportunities for FluMist and our influenza vaccine
franchise through additional label and geographical expansion, the
implementation of cell-culture manufacturing, pandemic vaccine
production and the out-licensing of intellectual property to other
vaccine manufacturers around the use of reverse genetics technologies."
* Pipeline: MedImmune is advancing the largest pipeline in its history,
with about 45 programs at various stages of development and
commercialization in three key areas of therapeutic focus: infectious
disease, cancer and inflammatory disease.
"We continue to build on our core scientific strengths in antibodies
and vaccines by incorporating cutting-edge technologies and
implementing best practices to maximize the efficiency and quality of
research and development efforts," stated James F. Young, Ph.D.,
president, research and development. "Key components of our approach
include integrating translational science methods, evolving governance
practices, and instituting scalable processes and infrastructure to
support and sustain MedImmune's rapid growth. Ultimately, our goal is
to discover and develop innovative products that fulfill our mission of
'advancing science to improve human health' while delivering
sustainable long-term growth for the company."
* Manufacturing and Process Development: MedImmune continues to
demonstrate its strengths in biological process development and
manufacturing across multiple technologies and products. It is an
industry leader in protein engineering, cell-culture production,
vaccine manufacturing and technological enhancements, such as the
virus-like particle technology that helped lead to the development of
vaccines to prevent cervical cancer caused by human papillomavirus.
"Since we began commercially producing Synagis in 1999, MedImmune has
become a world leader in high-yield cell culture process development,"
stated Bernardus N.M. Machielse, Drs., executive vice president,
operations. "Today, we are poised to use this expertise to support
development of cell-culture based influenza vaccines as part of our
commitment to helping protect U.S. citizens in the event of an
influenza pandemic. We are also preparing for broad-scale increases in
commercial production by expanding our cell-culture manufacturing
facilities in Frederick, Maryland, in support of our maturing
* Management: During 2006, MedImmune has substantially enhanced the
strength and depth of its management ranks. Most recently the company
expanded the leadership in its development organization with the
elevation of three new vice presidents and augmented its medical
affairs leadership with an additional vice president.
"Over the last year, we have been pleased to promote several highly
qualified internal leaders in our operations, clinical and development
areas, while supplementing our existing strengths with world-class
professionals in product portfolio management, infectious disease
medicine, government contracting, and sales and marketing," said Mr.
Mott. "As such, we have built an extraordinarily talented team of
senior leaders at MedImmune that are working together to provide better
medicines to patients, new medical options for physicians, rewarding
careers to employees and increased value to shareholders."
* Financial Guidance: MedImmune is providing an update to its previously
issued guidance for 2006, 2007 and 2009. MedImmune's guidance below
excludes share-based compensation expense for all periods mentioned. In
the aggregate, MedImmune expects that the impact of share-based
compensation expense before taxes will be approximately $32 million in
2006; $31 million to $33 million in 2007; and $55 million to $60
million in 2009. The associated impact to diluted EPS will be
approximately $0.10 for 2006, $0.09 to $0.10 for 2007, and $0.16 to
$0.18 for 2009.
-- 2006: MedImmune expects total revenue in 2006 to be approximately
$1.3 billion and its 2006 diluted EPS to be in the range of $0.17 to
$0.22. MedImmune also anticipates that, as a percentage of product
sales, in 2006: gross margins will be approximately 73 percent; R&D
will be approximately 38 percent; and SG&A will range from 40 to 42
percent. MedImmune also expects that in 2006 its tax rate will be
approximately 42 percent of pretax income; net other income will be
approximately 10 percent of product sales; and that it will end the
year with approximately 247 million diluted shares.
-- 2007: MedImmune anticipates that total revenue for 2007 will grow to
approximately $1.5 billion and that diluted EPS will be in the range
of $0.90 to $0.95. MedImmune also anticipates that, as a percentage
of product sales, in 2007: gross margins will be about 74 percent;
R&D will be in the range of 28 to 30 percent; and SG&A will be about
35 percent. MedImmune also expects that in 2007 its tax rate will
be approximately 36 percent of pretax income; its net other income
will be approximately 3 to 4 percent of product sales; and that it
will end the year with approximately 245 million diluted shares.
-- 2009: MedImmune anticipates that total revenue for 2009 will grow to
approximately $2 billion and that diluted EPS will be approximately
$2.00. MedImmune also anticipates that, as a percentage of product
sales, in 2009: gross margins will be in the range of 76 to 78
percent; R&D will be in the range of 27 to 29 percent; and SG&A will
be about 25 percent. MedImmune also expects that in 2009 its tax
rate will be approximately 36 percent of pretax income; its net
other income will be approximately 2 to 3 percent of product sales;
and that it will end the year with approximately 245 million diluted
"The years 2004 through 2006 marked a period of substantial investment in
our business. MedImmune is now poised to enter a new period of robust
financial growth with revenues increasing at a compound annual rate in excess
of 15 percent through 2009, margins expanding significantly, and earnings
growing approximately ten-fold," said Mr. Mott.
Guidance and objectives provided by the company are projections and are
based upon numerous assumptions, many of which MedImmune cannot control and
that may not develop as MedImmune expects. For a discussion of the risks
associated with these forward-looking statements, see the Disclosure Notice
DISCLOSURE NOTICE AND FORWARD LOOKING STATEMENTS
This announcement contains forward-looking statements regarding
MedImmune's future financial performance and business prospects. Those
statements involve substantial risks and uncertainties and contain statements
with 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 for
reasons set forth in MedImmune's Annual Report on Form 10-K for the year ended
December 31, 2005, its subsequent quarterly reports on Form 10-Q, its current
reports on Form 8-K filed for events occurring in 2006 and other public
disclosures and filings with the U.S. Securities and Exchange Commission.
Consequently, actual results may differ materially from those projected in the
MedImmune is also developing several products for potential future
marketing and the overall success of these development efforts is important
for the company's long-term prospects. 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 is received,
such products will 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 is offering a live webcast of its Analyst & Investor Day, which
will start today, Wednesday, December 6, 2006 at 9:00 a.m. eastern time. The
live webcast may be accessed in the investor section of MedImmune's website,
http://www.medimmune.com. A replay of the webcast will also be available via
the MedImmune website until January 3, 2007.
FluMist is indicated for active immunization for the prevention of disease
caused by influenza A and B viruses in healthy children and adolescents, 5 to
17 years of age, and healthy adults, 18 to 49 years of age. There are risks
associated with all vaccines, including FluMist. Like any vaccine, FluMist
does not protect 100 percent of individuals vaccinated. In studies of people
between the ages of 5 and 49 years, runny nose was the most commonly reported
side effect. Other common side effects included various cold-like symptoms,
such as headache, cough, sore throat, tiredness/weakness, irritability, and
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune system
problems. Pregnant women and people with certain medical conditions, asthma,
or reactive airways disease should not get FluMist.
Please see the Prescribing Information at
http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com,
or call 1-877-633-4411 for additional information.
Synagis is indicated for the prevention of serious lower respiratory tract
disease caused by RSV in pediatric patients at high risk of RSV disease and is
administered by intramuscular injection. Safety and efficacy were established
in infants with bronchopulmonary dysplasia (BPD), infants with a history of
premature birth (less than or equal to 35 weeks gestational age), and children
with hemodynamically significant congenital heart disease (CHD). Synagis has
been used in over 900,000 children since introduction in 1998. The first dose
of Synagis should be administered prior to commencement of the RSV season.
Patients, including those who develop an RSV infection, should continue to
receive monthly doses throughout the season.
Very rare cases of anaphylaxis (less than one case per 100,000 patients)
and rare hypersensitivity reactions have been reported with Synagis. Cases of
anaphylaxis were reported following re-exposure to Synagis and rare severe
hypersensitivity reactions occurred on initial exposure or re-exposure. If a
severe hypersensitivity reaction occurs, therapy with Synagis should be
permanently discontinued. If milder hypersensitivity reaction occurs, caution
should be used on re-administration of Synagis.
In clinical trials, the most common adverse events occurring at least 1
percent more frequently in Synagis-treated patients than controls were upper
respiratory infection, otitis media, fever, and rhinitis. Cyanosis and
arrhythmia were seen in children with CHD.
For full prescribing information for Synagis, see the company's website at
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious disease,
cancer and inflammatory diseases. With more than 2,500 employees worldwide,
MedImmune is headquartered in Maryland. For more information, visit the
company's website at http://www.medimmune.com.
SOURCE MedImmune, Inc.
CONTACT: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358, or Beatrice Pierre, +1-301-398-4905, all of MedImmune