MEDI Medimmune (MM)

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/. DATASOURCE: 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 Web site: http://www.medimmune.com/ http://www.flumist.com/

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