MedImmune Reconfirms 2009 Financial Targets of $2 Billion in Revenues and $2.00 in Earnings Per Diluted Share, Excluding Share-Based Compensation Expense, at 2006 Analyst Day

MedImmune Reconfirms 2009 Financial Targets of $2 Billion in Revenues and $2.00 in Earnings Per Diluted Share, Excluding Share-Based Compensation Expense, at 2006 Analyst Day

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 at http://www.medimmune.com/.

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 business experts."

  Key Highlights

   * 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
     pipeline."

   * 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
        shares.

"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 below.

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 forward-looking statements.

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.

Live Webcast

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.

About FluMist

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 muscle aches.

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.

About Synagis

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 http://www.medimmune.com/pdf/products/synagis_pi.pdf.

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/.

Website: http://www.medimmune.com/
Website: http://www.flumist.com/



Issuers of news releases and not PR Newswire are solely responsible for the accuracy of the content.
Terms and conditions, including restrictions on redistribution, apply.



Copyright © 1996-2003 PR Newswire Association LLC. All Rights Reserved.
A
United Business Media company.