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MedImmune
Contacts:
Lori Weiman
Senior Director, Corporate Communications
301-527-4321
Will
Roberts
Manager, Investor Relations
301-527-4358
On December 3, 2001, MedImmune announced that it has entered into a definitive merger agreement under which it will acquire Aviron through an exchange offer and merger transaction. Attached and incorporated herein by reference in its entirety as Exhibit 1 is a copy of a slide-show presentation given to investors by MedImmune to further explain the transaction.
Filed by MedImmune, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
Subject Company: Aviron
Commission File No. 000-20815
Jennison Associates Presentation
December 2001
This presentation may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's and Aviron's filings with the SEC. MedImmune and Aviron are developing 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. There can be no assurance that the offer and merger will close or that Aviron will be integrated successfully or without unanticipated costs.
We urge Aviron stockholders and other investors to read the registration statement on Form S-4, Schedule TO, preliminary prospectus, supplements, final prospectus and other exchange offer documents which have been filed or will be filed by MedImmune with the Securities and Exchange Commission and the related solicitation/recommendation statement filed by Aviron with the SEC. These documents contain important information which should be read carefully before any decision is made with respect to the offer. Documents filed with the SEC are available for free at the SEC's website at www.sec.gov. Documents are available for free from MacKenzie Partners, Inc., 800-322-2885.
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- MedImmune Overview
- •
- Aviron Acquisition
— Transaction Details
— Strategic Rationale
— FluMist™ Opportunity
— Aviron Pipeline Overview
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- Founded 1988, IPO 1991; headquarters in Gaithersburg, MD
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- $10B market cap, S&P 500, S&P 100, NASDAQ 100
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- Profitable since "98; $1.1B in assets; $655M in cash; $204M in LTM operating cash flow (38% of revenues)
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- Three core marketed products; focused on infectious disease, immunology and oncology
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- Vertically integrated
— 900 employees; 250-person R&D organization
— Two manufacturing plants: MD & Netherlands
— Three sales forces: hospital, pediatric & oncology
— New headquarters/R&D facility early 2003
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Synagis® | |
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• Humanized monoclonal antibody — Only MAb approved for infectious disease • Launched in U.S. September 1998 • Prevention of serious lower respiratory tract disease caused by RSV in high risk infants • Approved in 46 countries; ABT ex-US distributor, co-promotes in U.S. |
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Worldwide Synagis® Sales Seasonal Comparison (millions) |
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Ethyol® | |
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• Cytoprotectant agent — Reduce cisplatin toxicities in ovarian and NSCLC (1996) — Prevent radiation induced xerostomia in H/N (1999) • MEDI regained U.S. marketing rights October '01 • Schering-Plough ROW distributor • Current annualized worldwide sales $65M ($44M U.S.) |
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- $1.5B transaction value
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- $47.41 per AVIR share (28% premium) at 11/30/01
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- Stock-for-stock, tax free exchange offer
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- 1.075 MEDI shares for each AVIR share
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- Equity ownership
- •
- Standard closing conditions
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- Anticipate closing 1Q '02
— 86% MEDI
— 14% AVIR
Strategic Rationale
Excellent Strategic Fit
- •
- Scientific and medical overlap
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- Leverages infrastructure and capabilities
— Infectious disease
— Respiratory disease
— Vaccine technology
— Pediatrics
— Product development
— Regulatory
— Manufacturing/QA/QC
— Marketing and sales
Strategic Rationale
Unique Ability to Assess and Execute
| • R&D | Jim Young, PhD | |
• Clinical |
Frank Top, MD Ed Connor, MD |
|
• Regulatory |
Peter Patriarca, MD |
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• Mfg./QC/QA |
Gail Wasserman, PhD Ed Goley Ben Machielse |
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• Marketing |
Jeff Hackman |
Strategic Rationale
Excellent Financial Fit
- •
- Dilutive in 2002
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- Neutral to cash EPS in 2003
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- Double digit accretion thereafter
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- Accelerates growth targets '03-'06
— 25% annual revenue growth
— 30% annual EPS growth
Strategic Rationale
Excellent Financial Fit
| Financial Goals |
2002 |
2003 |
2006 |
|||
|---|---|---|---|---|---|---|
| Revenues | $900M | $1.1-$1.25B | >$2.1B | |||
| Cash EPS | $0.65-$0.70 | $1.15-$1.20 | >$2.50 |
2006 Operating Metrics (Goals)
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- 77% to 80% gross margin
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- 15% to 17% R&D
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- 21% to 23% SG&A
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- Over 40% EBITDA and pre-tax margins
Strategic Rationale
Create Premier Biotech Company
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- Two blockbuster products
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- Rich pipeline
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- Proven ability to deliver
— Synagis®
— FluMist™
— Antibodies and vaccines
— Four in Phase 3, five in Phase 2
— Product approvals
— Manufacturing scale-up
— Commercial success
— Financial results
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- Most common cause of medically attended acute respiratory illness
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- Acute febrile illness (up to 104oF)
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- High risk of mortality and other severe complications
— Chills, myalgia, cough, sore throat, nasal congestion, headache, malaise
— Pneumonia and influenza—6th leading cause of death in the US
- •
- Every Year in the U.S.
— 25-50 Million People Infected
— 20,000-50,000 Deaths
— 70 Million Lost Work Days
— 38 Million Lost School Days
— Costs Nearly $15 Billion
Source: MMWR 2001
Source: American Lung Association, 3/01
Influenza-related Morbidity and Mortality
Glezen WP. Emerging infections: pandemic influenza. Epidemiol Rev. 1996; 18(1), 64-76.
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- Vaccination is primary method for prevention
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- Three manufacturers
—Annual vaccination
— Inactivated vaccine
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- 80 million doses sold annually in U.S.
- •
- Anticipate proprietary vaccine pricing for FluMist™
—Aventis Pasteur
— Medeva/Evans
— American Home Products
—Growing at 10%
— Price doubled to approximately $5 recently
— Expected to reach $10 soon
FluMist™ |
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| Live | Active viral replication | X >20,000 vaccinated in ~20 studies | ||
Attenuated |
Mild Infection |
X Positively viewed by pediatric community |
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Cold-adapted Temperature-sensitive |
Replication restricted mainly to nasopharynx |
X Anticipated by recommending bodies |
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Trivalent |
A (H3N2, H1N1), B |
X Significant public health impact |
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Dose = 0.5 ml (~107 TCID50) 0.25 ml into each nostril |
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| Endpoint |
% Efficacy |
95% CI |
||
|---|---|---|---|---|
| Culture Confirmed Flu | 91.7 | 87.7, 94.4 | ||
Febrile Illness |
93.6 |
89.7, 96.0 |
||
Otitis Media |
96.2 |
87.6, 98.8 |
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Lower Respiratory Illness |
95.2 |
62.2, 99.4 |
| Endpoint |
% Reduction |
P-Value |
|||
|---|---|---|---|---|---|
| Missed daycare/preschool/school days | |||||
| Any Illness | 12.8 | 0.07 | |||
| Culture Positive Illness | 93.2 | <0.001 | |||
| Healthcare Provider Visits | |||||
| Any Illness | 11.2 | 0.02 | |||
| Culture Positive Illness | 92.1 | <0.001 | |||
| Parental Lost Work | |||||
| Any Illness | 12.6 | 0.17 | |||
| Culture Positive Illness | 93.0 | <0.001 | |||
Frozen FluMist BLA
Under FDA Review
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- BLA Submission: October 31, 2000
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- Pre-licensure inspections conducted 1H 2001
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- FDA advisory committee (VRBPAC): July 26-27, 2001
— 10 month PDUFA calendar
— Clinical sites
— Manufacturing sites
| Question 1: | Are the data adequate to support the efficacy of FluMist? | |
Adults 18-64 years of age? Yes 13-2 |
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Children 1-17 years of age? Yes 8-7 |
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Children 2-17 years of age? Yes 13-2 |
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Question 2: |
Are the data adequate to support the safety of FluMist in the population in which an indication is being sought (i.e., 1-64 years)? |
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No 10-4 |
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6 of 10 no votes were provisional pending final FDA data analysis |
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Issues |
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• Pneumonia |
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• Asthma |
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• Concurrent use |
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| |
FluMist |
Placebo |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study |
|||||||||||||
| N |
Cases |
>21d |
N |
Cases |
>21d |
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| AV006-Y1 | 1070 | 8 | 6 | 532 | 2 | 1 | |||||||
| AV006-Y2 | 917 | 2 | 1 | 441 | 0 | 0 | |||||||
| AV007 | 400 | 1 | 1 | 100 | 0 | 0 | |||||||
| AV0012-Y1 | 4298 | 2 | 1 | ||||||||||
| AV0012-Y2 | 5251 | 6 | 4 | ||||||||||
| AV0015 | 949 | 1 | 1 | ||||||||||
| AV0017 | 1175 | 3 | 3 | 70 | 0 | 0 | |||||||
| AV0019 | 6495 | 14 | 10 | 3238 | 10 | 6 | |||||||
| Total | 20,555 | 37 | 27 | 4,381 | 12 | 7 | |||||||
| Percent | 0.18 | % | 0.13 | % | 0.21 | % | 0.16 | % | |||||
Asthma Episodes (All Doses)
AV019—Healthy Children
| Age |
FluMist n/N |
Placebo n/N |
Rate per 1000 person-months FluMist/Placebo |
p Value |
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|---|---|---|---|---|---|---|---|---|
| 1-17 years | 58 / 6473 | 30 / 3216 | 4.6 / 4.8 | p=0.422 | ||||
| 1-8 years | 45 / 3769 | 21 / 1868 | 5.1 / 4.8 | p=0.418 | ||||
| 18-36 months | 16 / 728 | 2 / 369 | 9.3 / 2.3 | p=0.019 | ||||
| 12-17 months | 1 / 171 | 3 / 90 | 2.5 / 14.4 | p=0.067 |
Safety Database
(approximate number of participants)
| |
Pre-Aviron Data Set |
Included in BLA |
Included in Safety Update |
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|---|---|---|---|---|---|---|
| Healthy Children | 2,600 | 6,000 | 18,000 | |||
| Healthy Adults | 4,600 | 3,700 | 4,000 | |||
| High Risk | 900 | 700 | 2,000 | |||
| Total | 8,100 | 10,400 | 24,000 |
- •
- Complete response letter received 8/31/01
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- FDA requested additional information and clarification on clinical & manufacturing data
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- Response planned by December 31, 2001
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- FDA will re-start review clock (6 months)
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- Optimistic that available data will satisfy FDA
| Indication | Prevention of influenza in healthy persons age 18mo - 64yrs | |
ClinPharm |
93% Efficacy 37% ARROW flu-assoc. febrile otitis media Reduction in direct/indirect costs |
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Precautions/ warnings |
Do not administer to persons with prior Hx wheezing; do not administer with other vaccines |
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Side Effects |
Mild URI Sx in 20-50% Significant fever 2-5% |
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Dosage/admin |
0.5 cc intranasally (0.25 cc/nostril) 2 doses 30-60d apart for age <9yrs |
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Conclusions |
X Important medical advance
X New approach to immunization
X Data supports efficacy
X Draft clinical responses address major CR issues
X Primary issues that may affect timing and labeling
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- Concomitant immunization data
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- Wheezing/asthma
X Data support high likelihood of approval
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- AHP (Wyeth-Lederle Vaccines) alliance
- •
- Aviron manufactures frozen FluMist
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- Aviron/AHP share manufacturing of liquid FluMist
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- AHP pays (reimburses) sales and marketing expenses
- •
- Co-funding of clinical development costs
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- Aviron receives approximately 50% of worldwide end-user sales and operating profit
— U.S. co-promotion
— AHP distributes Ex-U.S.
— AHP records end-user sales
- •
- FluMist Enhancements
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- Herpes Simplex Vaccine
- •
- Cytomegalovirus Vaccine
- •
- Parainfluenza Virus-3/bovine PIV-3 Vaccine Hybrid
- •
- RSV Vaccine/bovine PIV-3 Vaccine Hybrid
—Liquid presentation
—Sterile filtration for virus harvest
—Reduced NAF
—Plasmid rescue for development of MVS
—Cell culture production
—Mapping of mutations in MDV
- •
- Excellent strategic fit
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- Excellent financial fit
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- Creates premier biotech company
DISCLOSURE NOTICE
Agenda
MedImmune, Inc.
Strong R&D Pipeline
Aviron Acquisition
Transaction Details
Strategic Rationale Excellent Strategic Fit
Strategic Rationale Unique Ability to Assess and Execute
Strategic Rationale Excellent Financial Fit
Strategic Rationale Excellent Financial Fit
Strategic Rationale Create Premier Biotech Company
The FluMist Opportunity
Influenza
Impact of Influenza
Influenza-related Morbidity and Mortality
Influenza
Efficacy
Frozen FluMist BLA Under FDA Review
VRBPAC Efficacy Discussion
VRBPAC: Safety Discussion
Pediatric Pneumonia
Asthma Episodes (All Doses) AV019—Healthy Children
Safety Database (approximate number of participants)
Complete Response Letter
Potential Label
FluMist™ Commercial Structure
R&D Programs
Aviron Acquisition