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
CV Therapeutics, Inc.
(Name of Subject Company (Issuer))
Apex 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)
126667104
(CUSIP Number of Class of Securities)
Gregg H. Alton, Esq.
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:
David A. Lipkin, Esq.
Michelle Sonu Park, Esq.
Brandee L. Shtevi, 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 CV Therapeutics Announced March 12, 2009 |
 Slide 2 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, 2008. |
 Slide 3 Safe Harbor Disclaimer (cont’d) This is neither an offer to purchase nor a solicitation of an offer to sell CV Therapeutics 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 CV Therapeutics 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 CV Therapeutics. |
 Slide 4 Gilead’s Platform Spans Four Therapeutic Areas Atripla Atripla Truvada Truvada Viread Viread Emtriva Emtriva Elvitegravir Elvitegravir (Ph III) GS 9350 (Ph I) GS 9350 (Ph I) Integrase Integrase FDR FDR (Ph I) PAH PAH Letairis Letairis Flolan Flolan Cicletanine Cicletanine (Ph II) (Ph II) Resistant Resistant Hypertension Hypertension Darusentan Darusentan (Ph III) (Ph III) HBV HBV Hepsera Hepsera Viread Viread HCV HCV GS 9450 (Ph II) GS 9450 (Ph II) GS 9190 (Ph II) GS 9190 (Ph II) NASH NASH GS 9450 (Ph II) GS 9450 (Ph II) HIV/AIDS HIV/AIDS Cardiovascular Cardiovascular Liver Disease Liver Disease Respiratory Respiratory Influenza Influenza Tamiflu Tamiflu CF CF Aztreonam Aztreonam Lysine Lysine (Applications Pending) (Applications Pending) GS 9310 / 11 (Ph II) GS 9310 / 11 (Ph II) GS 9411 (Ph I) GS 9411 (Ph I) Bronchiectasis Bronchiectasis Aztreonam Aztreonam Lysine Lysine (Ph II) (Ph II) IPF IPF Ambrisentan Ambrisentan (Ph III) (Ph III) |
 Slide 5 2008 Financial Highlights Full year total revenues of $5.34 billion, up 26 percent over 2007 Full year product sales of $5.08 billion, up 36 percent over 2007 Cash flow from operations of $2.2 billion Non-GAAP operating margin of 51% from product sales (1) $3.24 billion in cash, cash equivalents and marketable securities as of December 31, 2008 (1) Excludes the impact of stock-based compensation expense.
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 Slide 6 Organizational Strengths Gilead’s reputation as an innovative company resonates across our key audiences Productive drug discovery and development track record – Seven product approvals over the last seven years Efficient organizational structure Maintain strong connections with the communities we serve |
 Slide 7 Vision for CV Therapeutics Ranexa for chronic angina with new, stronger US label – Specialty sales force detailing cardiologists Lexiscan opportunity in EU Proven development and regulatory organization – Improved opportunity for Letairis and darusentan Pipeline of cardiovascular products Improved future earnings profile and growth rate Bolsters Gilead’s presence in the
cardiovascular space by providing: |
 Slide 8 Transaction Overview Cash tender offer at $20.00 per share Transaction value of $1.4 B Tender offer expected to close within Q2 09 – Subject to minimum tender requirement and Hart-Scott-Rodino (antitrust) clearance |
 Slide 9 Contribution from 2 additional marketed products – Ranexa (US sales and EU royalty) – Lexiscan (North American royalty, unpartnered in the EU and Japan) Increased spend for sales and marketing Increased clinical spend Increased discovery spend Maintain site Rationalization of overlapping positions and functions Contribution from 2 additional marketed products – Ranexa (US sales and EU royalty) – Lexiscan (North American royalty, unpartnered in the EU and Japan) Increased spend for sales and marketing Increased clinical spend Increased discovery spend Maintain site Rationalization of overlapping positions and functions REVENUES REVENUES EXPENSES EXPENSES Sales & Marketing Clinical Development Discovery Research G&A Sales & Marketing Clinical Development Discovery Research G&A Impact on Gilead’s P&L * * Expected to be dilutive in 2009, neutral to accretive in 2010, and accretive in 2011 and beyond. |
 Slide 10 CV Therapeutics’ Products and Pipeline Would Significantly Augment Gilead’s Cardiovascular Efforts Product MOA Clinical Indication(s) Stage Partnerships Ranexa ® (ranolazine ER) Late sodium channel inhibitor Chronic Angina Marketed (US and EU) Licensed from Roche, Menarini has E.U. rights (CV Therapeutics has co-promote in UK & Germany) Lexiscan ® (regadenoson) A 2 a-adenosine receptor agonist Myocardial Perfusion Imaging Marketed Astellas has North American rights Unpartnered Ex-NA Adentri ® (CVT-124) A 1 -adenosine receptor antagonist Acute Heart Failure Phase III Biogen Idec has worldwide rights Tecadenoson A 1 -adenosine receptor agonist Atrial Fibrillation Phase II Unpartnered CVT-6883 A 2b -adenosine receptor antagonist Pulmonary Diseases (asthma, COPD, IPF) Phase I Unpartnered CVT-3619 Partial A 1 - adenosine receptor agonist Diabetes Phase I Unpartnered |
 Slide 11 Ranexa: Granted New U.S. Indication in November 2008 Ranexa is indicated for the treatment of chronic angina. Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers. |
 Slide 12 Chronic Angina: US Patient Waterfall 75 10,197 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000 11,000 1,071 Refractory Angina 3,4,5 Diabetes/Angina Ranexa Pts 6 1,784 (25%) 1,499 (21%) 7,138 Treated Angina 2 Angina Prevalence 1 3,854 Other 268 HF, 225 7% Chronic HF/Angina 70% 15% Patients (000s) 1AHA Statistical Update. Heart Disease and Stroke Statistics – 2009 update. 2 F.C. Wiest, et. al. Suboptimal Pharmacotherapeutic Management of Chronic Stable Angina in the Primary Care setting. Am J Med. 2004;117:234 –241. 3 Gilead Market Research. 4Diabetes rate in angina patients in the CARISA trial 23% and in the Marisa trial was 24.1%. 5Cardiovascular Resource Group Report (Heart Failure 2008–2017). 6Trx data analysis (Wolters Kluwer). Refractory angina patients include patients with symptoms despite maximum tolerated doses of Beta Blockers, Calcium Channel Blockers, and Long Acting Nitrates Significant portions of treated and refractory angina patients have co- morbidities (Diabetes, Heart Failure). |
 Slide 13 Provides Opportunity to Relaunch Ranexa Sales and marketing roadmap for relaunch – Size salesforce appropriately (currently 170 reps) – Target specialty and intervention cardiologists who treat refractory angina patients – Leverage proven medical education model Favorable revisions to the label based on proven safety in outcomes study in 6,500 high-risk coronary patients (MERLIN) – Removed contraindications for diltiazem and verapamil – Can be used with major classes of cardio-protective drugs – HbA1c reduction now referenced – Claims for safe reductions in ventricular tachycardia, supraventricular tachycardia, new onset atrial fibrillation, bradycardia |
 Slide 14 Limitations of older therapies – Beta Blockers: bradycardia (especially in the elderly), fatigue, drowsiness and depression – Calcium Channel Blockers: may cause bradycardia, dizziness and peripheral edema – Long Acting Nitrates: occurrence of tolerance, headaches, dizziness and contraindicated with ED drugs COURAGE trial supports medical management prior to stenting 10% growth in the angina population since 2006 – Currently 9.8M patients in US, with 500K new patients annually Angina Largely Underserved by Previous Classes of Drugs 1 – AHA 2009 Heart & Stroke Stats (500k is pts older than 45) 1 |
 Slide 15 64% YOY Growth in US Ranexa Sales Growth through 11/6/08 was with old label Increasingly favorable managed care status ($ in millions) $15.3 $18.4 $20.9 $22.0 $25.4 $30.3 $31.5 $12.0 Q1'07 Q2'07 Q3'07 Q4'07 Q1'08 Q2'08 Q3'08 Q4'08 |
 Slide 16 Ranexa Opportunity in Europe Menarini has EU rights to Ranexa – Strong cardiology commercial presence in EU – Launched in UK and Germany (March 2009) – Other EU countries to follow In most European countries, 20,0000 - 40,000 individuals per million suffer from angina 1 – European Heart Journal, 2006 Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). |
 Slide 17 Successful Lexiscan U.S. Launch Lexiscan ® (regadenoson) launched by Astellas in the U.S. in June 2008 ($46 M sales in 2008) Already taking substantial portion of pharma stress market Expanding Myocardial Perfusion Imaging (MPI) market 1 – "Stress Protocols and Tracers" section of the ASNC Imaging Guidelines for
Nuclear Cardiology Procedures ) 1996 1998 2000 2002 2004 2006 MPI Scans (in millions) Pharma Stress (in millions) 7.7 3.4 7.1 3.1 6.0 2.5 5.0 1.8 4.0 1.2 3.4 0.9 |
 Slide 18 Regadenoson EU Filing in 2009, Potential Launch in 2010 Ex-US rights unpartnered; MAA submission planned in 2009 – Based on US NDA including 10 clinical trials in 1,651 patients Eligibility for centralized filing confirmed EMEA pre-submission meeting completed Will work to define commercialization strategy 1 – NEJM 360:213, 2009 2 – Multiple detector computed tomography |
 Slide 19 Adentri for Acute Heart Failure A 1 adenosine antagonist which maintains renal function while facilitating diuresis in patients with heart failure Licensed to Biogen Idec in1997 – Potential for milestone and royalty payments Ongoing Phase III study (TRIDENT-1; began 8/08) – Assess the efficacy and safety of IV Adentri ® dosed up to 5 days on body weight in ADHF patients with impaired renal function 1 – JACC Vol 50, No. 7, 2007 Phase II Results Change from Baseline in Urine Volume -400 -200 0 400 600 800 Day 1 Day 6 Day 10 3 mg 15 mg 75 mg 225 mg Placebo 200 |
 Slide 20 Tecadenoson for Rapid Atrial Fibrillation A 1 adenosine receptor agonist which produces rapid rate control without drop in blood pressure Phase III results in PSVT patients – Rapidly convert PSVT in up to 90% of patients to normal heart rhythm – No significant adverse symptoms or hemodynamic side effects – Development in PSVT halted due to small market opportunity Completed second Phase II in rapid atrial fibrillation (AF) patients in Q308 – Intravenous tecadenoson co-administered with ultra low doses of beta-blockers – Demonstrated synergy in providing adequate rate control during atrial fibrillation without decreasing blood pressure – Determining future development strategy in AF |
 Slide 21 CVT-3619 for Diabetes A small molecule partial A 1 adenosine receptor agonist – Orally bioavailable, once-a-day dosing Inhibitor of adipose tissue lipolysis: lowers circulating FFA1 – Improves insulin sensitivity – Decreases plasma triglycerides by inhibiting the breakdown of triglycerides from the liver – May raise HDL Completed first Phase 1 study – Safe and well-tolerated up to 1800 mg – No significant effect on HR, BP and PR interval – Appears to elicit reduction in circulating FFA – Plan to start multiple ascending dose study in 2009 FFA Activate A 1 agonist Triglycerides Insulin Sensitivity HDL Proposed Physiologic Cascade: 1 – Based on preclinical data |
 Slide 22 CVT-6883 for Pulmonary Disease (Asthma, COPD, IPF) Proprietary small molecule that is anti-fibrotic, anti- inflammatory and anti-angiogenic First in class selective antagonist of A 2B adenosine receptor mediated actions (does not attenuate A 1 , A 2A , or A 3 -receptor mediated actions) Completed three Phase 1 studies – Good oral absorption – Safe and well tolerated at concentrations that exceed 100x receptor binding affinity – PK coverage consistent with once/day dosing – Number of patients exposed >100 |
 Slide 23 Gilead’s Platform Spans Four Therapeutic Areas Atripla Atripla Truvada Truvada Viread Viread Emtriva Emtriva Elvitegravir Elvitegravir (Ph III) (Ph III) GS 9350 (Ph I) GS 9350 (Ph I) Integrase Integrase FDR FDR (Ph I) (Ph I) PAH PAH Letairis Letairis Flolan Flolan Cicletanine Cicletanine (Ph II) (Ph II) Resistant Resistant Hypertension Hypertension Darusentan Darusentan (Ph III) (Ph III) HBV HBV Hepsera Hepsera Viread Viread HCV HCV GS 9450 (Ph II) GS 9450 (Ph II) GS 9190 (Ph II) GS 9190 (Ph II) NASH NASH GS 9450 (Ph II) GS 9450 (Ph II) HIV/AIDS HIV/AIDS Cardiovascular Cardiovascular Influenza Influenza Tamiflu Tamiflu CF CF Aztreonam Aztreonam Lysine Lysine (Applications Pending) (Applications Pending) GS 9310 / 11 (Ph II) GS 9310 / 11 (Ph II) GS 9411 (Ph I) GS 9411 (Ph I) Bronchiectasis Bronchiectasis Aztreonam Aztreonam Lysine Lysine (Ph II) (Ph II) IPF IPF Ambrisentan Ambrisentan (Ph III) (Ph III) Respiratory Respiratory Liver Disease Liver Disease |
 Slide 24 CV Therapeutics Product Portfolio Significantly Augments This Platform Gilead Gilead Tamiflu Tamiflu - - Influenza Influenza Aztreonam Aztreonam Lysine - Lysine - CF CF GS 9310 / 11 - GS 9310 / 11 - CF CF GS 9411 - GS 9411 - CF CF Aztreonam Aztreonam Lysine - Lysine - Bronchiestasis Bronchiestasis Ambrisentan Ambrisentan - - IPF IPF CV Therapeutics CV Therapeutics CVT-6883 - CVT-6883 - Pulmonary Diseases Pulmonary Diseases Respiratory Respiratory Gilead Gilead Letairis Letairis - - PAH PAH Flolan Flolan - - PAH PAH Cicletanine Cicletanine - - PAH PAH Darusentan Darusentan - - Resistant Hypertension Resistant Hypertension CV Therapeutics CV Therapeutics Ranexa Ranexa - - Angina Angina Lexiscan Lexiscan - - MPI MPI Adentri Adentri - - Acute Heart Failure Acute Heart Failure Tecadenoson Tecadenoson - - Atrial Atrial Fibrillation Fibrillation CVT-3619 - CVT-3619 - Diabetes Diabetes Cardiovascular / Metabolic Cardiovascular / Metabolic |
 Slide 25 Gilead and CV Therapeutics: Strength in Partnership S&M relaunch resource Commercial Operations infrastructure Medical Affairs experience European operating affiliates Gilead Revised Ranexa label US Cardiology sales team Cardiovascular clinical know-how Managed Care network CV Therapeutics CV Therapeutics |
 Slide 26 Vision for CV Therapeutics Ranexa for chronic angina with new, stronger US label – Specialty sales force detailing cardiologists Lexiscan opportunity in EU Proven development and regulatory organization – Improved opportunity for Letairis and darusentan Pipeline of cardiovascular products Improved future earnings profile and growth rate Bolsters Gilead’s presence in the cardiovascular space by providing: |