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Filed
by MedImmune, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14d-2 of the Securities Exchange Act of 1934
Subject Company: Aviron
Commission File No. 000-20815
JP Morgan H&Q
20th Annual Healthcare Conference
January 10, 2002
DISCLOSURE NOTICE:
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 Aviron will be integrated successfully or without unanticipated costs.
Aviron stockholders and other investors are urged 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 by MedImmune with the Securities and Exchange Commission and the related solicitation/recommendation statement which has been 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.
- •
- MedImmune
Introduction
- •
- Aviron
Acquisition and Strategic Rationale
- •
- FluMist™
Opportunity
- •
- Conclusions
- •
- Founded
1988, IPO 1991
- •
- Headquarters
in Gaithersburg, MD
- •
- $10B
market cap
- •
- S&P
500, S&P 100, NASDAQ 100
- •
- Profitable
since 1998
- -
- $540M
2000 revenues (72% 3-year CAGR)
- -
- $1.1B
assets ($655M cash)
- -
- $204M LTM cash flow (38% of revenues)
Synagis® |
||||
|
• • |
Humanized MAb to prevent serious RSV disease in high risk infants 2000-2001 season end-user sales $490M |
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Ethyol® |
||||
|
• • • |
Chemoprotectant in ovarian and NSCLC Radioprotectant in head and neck cancer Q3 annualized end-user sales $65M |
||
CytoGam® |
||||
|
• • |
Attenuation of cytomegalovirus disease in solid organ transplantation patients 2000 end-user sales $36M |
||
- •
- Vertically
integrated
- -
- 900 employees:
- -
- Three manufacturing plants:
250 R&D, 300 S&M, 200 Mfg, 150 SG&A
- -
- Three sales forces:
- •
- R&D
focus in infectious disease, immunology and oncology
- •
- Core competencies in antibodies and vaccines
Gaithersburg, Frederick & Nijmegen
Hospital (60), Pediatric (90) & Oncology (60)
- •
- $1.5B
transaction value
- •
- $47.41
per AVIR share (28% premium) at 11/30/01
- •
- Stock-for-stock,
tax free exchange offer
- •
- 1.075
MEDI shares for each AVIR share
- •
- Equity
ownership
- -
- 86% MEDI
- -
- 14% AVIR
- •
- Exchange
offer expired midnight last night
- -
- 94% of AVIR shares tendered
- •
- Anticipate closing by Monday
Strategic Rationale
Excellent Strategic Fit
- •
- Scientific
and medical overlap
- -
- Infectious disease
- -
- Respiratory disease
- -
- Vaccine technology
- -
- Pediatrics
- •
- Leverages
infrastructure and capabilities
- -
- 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 |
||
• |
Mfg./QC/QA |
Gail Wasserman, PhD Ed Goley Ben Machielse |
||
• |
Marketing |
Jeff Hackman |
Strategic Rationale
Excellent Financial Fit
- •
- Dilutive
in 2002
- •
- Neutral
to cash EPS in 2003
- •
- Double
digit accretion thereafter
- •
- 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)
- •
- 77%
to 80% gross margin
- •
- 15%
to 17% R&D
- •
- 21%
to 23% SG&A
- •
- Over 40% EBITDA and pre-tax margins
Strategic Rationale
Create Premier Biotech Company
- •
- Two
blockbuster products
- -
- Synagis®
- -
- FluMist™
- •
- Rich
pipeline
- -
- Antibodies and vaccines
- -
- 12 products in clinical testing
- •
- Proven
ability to deliver
- -
- Product approvals
- -
- Manufacturing scale-up
- -
- Commercial success
- -
- Financial results
- •
- Most
common medically attended acute respiratory illness
- -
- Fever, chills, myalgia, cough, sore throat, nasal congestion, headache, malaise
- •
- Annual
U.S. disease burden
- -
- 20-50M
people infected
- -
- 20,000-50,000
deaths
- -
- 70M
lost work days and 38 M lost school days
- -
- Costs nearly $15B
Sources: MMWR 2001; American Lung Association, 3/01
Glezen WP. Emerging infections: pandemic influenza. Epidemiol Rev. 1996; 18(1),64-76.
- •
- Vaccination
is primary method for prevention
- -
- Annual
vaccination
- -
- Inactivated vaccine
- •
- Three
manufacturers
- -
- Aventis
Pasteur
- -
- Medeva/Evans
- -
- American Home Products
- •
- 80 million
doses sold annually in U.S.
- -
- Growing
at 10%
- -
- Price
doubled to approximately $5 recently
- -
- Expected to reach $10 soon
- •
- Anticipate proprietary vaccine pricing for FluMist™
|
FluMist™ |
|
• >20,000 vaccinated in ~20 studies • Positively viewed by pediatric community • Anticipated by recommending bodies • Significant public health impact |
- •
- Biologics
License Application submitted October 2000
- •
- Pre-licensure
inspections 1H 2001
- -
- Clinical
sites
- -
- Manufacturing sites
- •
- Form 483
observations responded to July 2001
- •
- FDA advisory committee (VRBPAC) July 26-27, 2001
FluMist™ Efficacy
- •
- Strong endorsement overall
- •
- Limited data in children under 18 months
FluMist™ Safety
- •
- FDA analysis in progress
- •
- Database incomplete
- •
- Provisional rejection by Committee
- •
- Issues
highlighted
- —
- Pneumonia
- —
- Concurrent immunizations
- •
- Complete Response Letter received August 2001
- •
- FDA requested additional information and clarification on clinical results and manufacturing
- •
- Response
submitted January 8, 2002
- -
- Significant new data and additional analyses
- -
- Final study reports for Kaiser and Texas trials
- -
- Objective to obtain 2002 approval
- •
- Indication
- -
- Prevention
of influenza in healthy individuals
>18 months and <65 years
- •
- Clinical
Pharmacology
- -
- 93% efficacy
- -
- 37% reduction in flu-associated febrile otitis media
- -
- Reduction in direct/indirect costs
- •
- Precautions/Warnings
- -
- Do not use in persons with history of asthma/wheezing
- -
- Do not administer with other vaccines
- •
- Side
Effects
- -
- Mild URI symptoms in some vaccinees
- -
- Low incidence of fever
- •
- Dosage/Administration
- -
- 0.5cc Intranasally (0.25 cc in each nostril)
- -
- One dose per season, except first use in children <9 years old (two doses)
FluMist™
Product Development Strategy
- •
- Post-marketing
studies planned
- -
- Concurrent immunizations
- -
- Subjects with asthma or history of wheezing
- •
- Yield improvements and capacity expansion
- •
- Product
enhancements
- -
- Liquid formulation in Phase 3
- -
- Room temperature formulation in development
- -
- Cell culture production in research
- •
- Aviron & AHP co-promote in U.S.; AHP distributes ex-U.S.
- •
- AHP records all end-user sales
- •
- Aviron manufactures frozen FluMist™
- •
- Aviron/AHP share manufacturing of liquid FluMist™
- •
- AHP pays (reimburses) sales and marketing expenses
- •
- Co-fund clinical development costs
- •
- Aviron receives approximately 50% of WW end-user sales and profit
- •
- Tremendous disease burden
- •
- New approach to immunization
- •
- Data supports efficacy
- •
- Complete Response Letter reply addresses remaining issues
- •
- Data support high likelihood of approval
- •
- Proven
Success of MedImmune
- -
- Product development
- -
- Commercialization
- -
- Financial results
- •
- FluMist™ offers a near term product opportunity with blockbuster potential
- •
- Aviron acquisition accelerates growth, diversifies revenues, strengthens pipeline, and creates a premier biotech company
Agenda
MedImmune
MedImmune
Aviron Acquisition
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
Influenza
Influenza
FluMist™ Regulatory Status
Advisory Committee Outcome
FluMist™ Regulatory Status
Potential Label
FluMist™ Product Development Strategy
FluMist™ Commercial Structure
FluMist™ Opportunity
Combined Pipeline
Conclusion