SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Schedule TO
Tender Offer Statement under Section 14(d)(1) or 13(e)(1)
of the Securities Exchange Act of 1934
Myogen, Inc.
(Name of Subject Company (Issuer))
Mustang Merger Sub, Inc. (Offeror)
Gilead Sciences, Inc. (Parent of Offeror)
(Names of Filing Persons)
COMMON STOCK, PAR VALUE $0.001 PER SHARE
(Title of Class of Securities)
62856E104
(CUSIP Number of Class of Securities)
Gregg Alton
Senior Vice President and General Counsel
Gilead Sciences, Inc.
333 Lakeside Drive,
Foster City, California 94404
Tel: ( 650) 574-3000
(Name, address, and telephone number of person authorized to receive notices
and communications on behalf of filing persons)
with copies to:
Richard E. Climan, Esq.
David A. Lipkin, Esq.
Cooley Godward Kronish LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, CA 94306-2155
Tel: (650) 843-5000
Fax: (650) 849-7400
Calculation of Filing Fee
| Transaction Valuation | Amount of Filing Fee | |
| Not Applicable | Not Applicable |
| ¨ | Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number or the form or schedule and the date of its filing. |
| x | Check the box if the filing relates to preliminary communications made before the commencement of a tender offer. |
Check the appropriate boxes below to designate any transactions to which the statement relates:
| x | third-party tender offer subject to Rule 14d-1. |
| ¨ | issuer tender offer subject to Rule 13e-4. |
| ¨ | going-private transaction subject to Rule 13e-3. |
| ¨ | amendment to Schedule 13D under Rule 13d-2. |
Check the following box if the filing is a final amendment reporting the results of the tender offer: ¨
Gilead to Acquire Myogen
(Announced October 2, 2006)
Safe Harbor Disclaimer
This presentation contains “forward-looking” information (within the meaning of the Private Securities Litigation Reform Act of 1995) that involves substantial risk and uncertainty. Actual results may differ materially based on a variety of factors, particularly those relating to the development and marketing of pharmaceutical products as described in the “Risk Factors” section of Gilead’s SEC reports, including the report on Form 10-K for the year ended December 31, 2005.
Safe Harbor Disclaimer (cont’d)
This is neither an offer to purchase nor a solicitation of an offer to sell Myogen shares. The tender offer will only be made through an offer to purchase, letter of transmittal and related tender offer materials. At the time the expected tender offer is commenced, Gilead will file these tender offer materials with the Securities and Exchange Commission and Myogen will file a solicitation/ recommendation statement with respect to the offer. The tender offer materials and the solicitation/recommendation statement will contain important information. Stockholders are urged to read this information carefully before making any decisions about the tender offer. The tender offer materials, certain other offer materials, and the solicitation/recommendation statement will be sent free of charge to all stockholders of Myogen.
Gilead 2006 Highlights
First half 2006 revenues of $1.38 billion $3.3 billion in total cash as of June 30, 2006* U.S. filing and approval of Atripla
– First one pill, once daily antiretroviral regimen
Acquisition of Raylo (Edmonton, Alberta, Canada)
– Provides manufacturing site to support scale-up and commercial manufacturing of our growing product pipeline (GS 9137, GS 9132)
Acquisition of Corus (Seattle, WA)
– Provides a near-term product opportunity with aztreonam lysine for cystic fibrosis
– Establishes a center of pulmonology expertise
*Does not include the impact of either the Corus acquisition (closed 8/4/06) or Raylo acquisition (anticipated to close in Q406)
Vision for Myogen
Near-term and long-term revenue potential
Strengthens focus on products for pulmonary diseases
Adds key employees and expertise
Why Myogen?
Ambrisentan provides significant near-term and long-term revenue potential
– Anticipated Q406 NDA filing
– Has the profile to become the endothelin receptor antagonist of choice for pulmonary hypertension
2005 ERA market $480 million (Tracleer)
total global market for PAH $900 million (2005)
– Potential for expansion into other indications
Further strengthens Gilead’s focus on small molecules for pulmonary disease
– Synergy with Corus/aztreonam lysine for cystic fibrosis
leverage R&D expertise in respiratory disorders for new product formulations
– Targeted sales forces focused on specialty pulmonologists
– Additional respiratory licensing and M&A opportunities
Myogen Expands Gilead’s Respiratory Franchise
Current Gilead
Anti-infectives
HIV
Hepatitis
Antifungals
Gilead Vision: 2007 and Beyond
Expand Pulmonary Franchise
Respiratory Therapies $26 Billion Market
Anti-infectives for Respiratory Diseases
Pulmonary Arterial Hypertension
($900 Million+ Market)
Corus: Inhaled Antibiotics for CF
Myogen: Endothelin Receptor Antagonist for PAH
Transaction Overview
Cash tender offer at $52.50 per share
Transaction value of $2,477 M(1)
Tender offer expected to close within Q406
– Subject to minimum tender requirement and Hart-Scott-Rodino (antitrust) clearance
| (1) |
|
Based on basic shares outstanding and exercisable options “in the money” (Treasury). |
Myogen’s Product Pipeline
Product Class Clinical Indication(s) Stage Partnerships
Flolan® IV prostacyclin Pulmonary arterial hypertension Marketed ($3.75—4.5 M in 2006E*) 3-year U.S. distribution rights from GSK
Ambrisentan Endothelin receptor antagonist Pulmonary arterial hypertension Phase III completed GSK commercialization rights ex-U.S.; Licensed from Abbott
Darusentan Endothelin receptor antagonist Resistant hypertension Phase III Licensed from Abbott
Cardiac Hypertrophic Signaling Novel targets including HDAC inhibitors Heart failure Discovery Novartis – discovery/development partnership with co- promotion/profit sharing option by Myogen
*Guidance provided by Myogen on Q206 earnings release; recognize Flolan revenue net of the transfer price from GSK and specialty pharmacy distribution costs
PAH Facts and Figures
Pulmonary arterial hypertension (PAH)
– Rare disease, typically progressive and fatal, characterized by complex, non-specific signs and symptoms and difficult to detect in early stages
untreated median survival ~ 2.8 years from diagnosis
Prevalence/incidence
– PAH afflicts approximately 200,000-250,000 patients worldwide
affects between 50,000-100,000* Americans with ~5,000 newly diagnosed cases reported annually
Demographics
– PAH occurs twice as frequently in females as in males and tends to be diagnosed between the ages of 20 and 50
– Limited existing therapies (ERA, PDE-5 inhibitors, prostacyclin analogs)
– Concentrated physician base (120 U.S. specialist centers)
Source(s): Decision Resources, Cardium, Pulmonary Hypertension, 2005 (prevalence data from DR primary market research/MD survey * Pfizer estimate
Ambrisentan: Best in Class Potential
Pivotal Phase III studies complete (ARIES I and II)
Clinical studies to date have demonstrated:
– Similar efficacy as Tracleer (Actelion)
– Better safety profile (significantly less liver toxicity) and fewer drug-drug interactions (coumadin, sildenafil)
– High potency and bioavailability allowing low doses for therapeutic effect
– Multiple dose options
– Once daily dosing
On track for Q406 U.S. NDA filing
– Designated orphan drug status
Darusentan:
Candidate for Resistant Hypertension
Resistant hypertension
– Defined as uncontrolled blood pressure while on appropriate three-drug+ regimen
– ~ 7 million drug-treated hypertensive patients on 3+ drug regimens (ACE inhibitor, ARBs, beta blockers, calcium channel blockers, diuretics)
Estimated 2—3 million U.S. patients (30—40%) are resistant or uncontrolled
Currently in Phase III studies in resistant hypertension
– Positive Phase IIb results
– Phase III initiated
Myogen Personnel to Support Clinical Programs
Currently ~160 Myogen employees at site in Westminster, CO (near Denver)
Maintain Westminster site as an R&D center
Analyses underway to evaluate synergies
Ambrisentan U.S. Launch Plans
Myogen currently has a total sales team of 17 promoting Flolan Grow sales team to 75-100 by the time of ambrisentan launch (by year-end 2007) Commercial organization to report into EVP Commercial (Kevin Young) and be run out of California-based headquarters
Impact on Gilead’s P&L
REVENUES
Contribution from 2 additional marketed products
– Flolan (minimal impact)
– Ambrisentan U.S. in 2007
– GSK Royalty (Ambrisentan EU) in 2008
EXPENSES
Sales & Marketing
Increased spend to launch ambrisentan in the U.S.
Clinical Development
Increased clinical spend
Discovery Research
Increased discovery spend
– Minimal due to Novartis collaboration
G&A
Maintain site
Rationalization of overlapping positions and functions
Gilead’s Pipeline:
Potential for Multiple Product Launches through 2011
2007
2008
2009
2010
2011
Ambrisentan—PAH (U.S.)
Atripla—HIV (EU)
Aztreonam lysine—CF (U.S.) GS 9137—HIV (U.S.) Tenofovir DF—HBV (U.S.) Ambrisentan—PAH (EU)
Tenofovir DF—HBV (EU) Aztreonam lysine—CF (EU) GS 9137—HIV (EU)
Why Myogen?
Ambrisentan provides significant near-term and long-term revenue potential
– Anticipated Q406 NDA filing
– Has the profile to become the endothelin receptor antagonist of choice for pulmonary hypertension
2005 ERA market $480 million (Tracleer)
total global market for PAH $900 million (2005)
– Potential for expansion into other indications
Further strengthens Gilead’s focus on small molecules for pulmonary disease
– Synergy with Corus/aztreonam lysine for cystic fibrosis
leverage R&D expertise in respiratory disorders for new product formulations
– Targeted sales forces focused on specialty pulmonologists
– Additional respiratory licensing and M&A opportunities
