Annual Report on Form 20-F

Transcription

1 Annual Report on Form 20-F

2 2 Teva at a Glance Founded in 1901 by three young pharmacists, today Teva Pharmaceutical Industries Ltd. is a leader in the global pharmaceutical industry, providing medicines essential to people s health all over the world. 1 out of every 7 prescriptions in the United States and 1 out of every 6 prescriptions in the U.K. is filled with a Teva product. Ranks among the top 10 pharmaceutical companies in the world The largest global producer of generic medicines Established specialty medicines business Operates in 60 countries, and distributes products all over the world Approximately 45,000 employees 64 billion tablets and capsules manufactured in 55,000+ product variants 1,000 molecules Chairman Dr. Phillip Frost President & CEO Erez Vigodman Web address NYSE ticker TEVA

3 3 Financial Highlights Amounts in millions of U.S. dollars except per share amounts Net revenues 20,314 20,317 18,312 16,121 13,899 Gross profit GAAP 10,707 10,652 9,515 9,065 7,367 Gross profit NON GAAP* 11,895 12,071 10,705 9,669 8,119 Operating income - GAAP 1,649 2,205 3,109 3,871 2,405 Operating income - NON GAAP* 5,198 5,715 5,253 4,933 3,853 Net income attributable to Teva - GAAP Net income attributable to Teva - NON GAAP* Earnings per share attributable to Teva - GAAP Diluted ($) Earnings per share attributable to Teva - NON GAAP* Diluted ($) 1,269 1,963 2,759 3,331 2,000 4,255 4,671 4,438 4,134 3, * See non GAAP reconciliation beginning on page 79 of our Annual Report on Form 20 - F Dividends per share in the past 5 years* * According to USD/NIS exchange rate in Feb $0.91 $1.14 $ $ $0.68 Net revenues Other* 10% Generics 49% ROW** 19% US 52% by segment by markets Specialty 41% Europe* 29% * Other activities include our OTC business with P&G, distribution services primarily in Israel and Hungary, and sales of medical devices * All members of the European Union, Switzerland, Norway, Albania and the countries of former Yugoslavia. ** Primarily Japan, Canada, Latin America, Israel and Russia

4 Our Business Generics Specialty Chemical and therapeutic equivalents of originator pharmaceuticals in a variety of dosage forms: tablets, capsules, ointments, creams, liquids, injectables and inhalants. Strong innovation power focused on key therapeutic areas such as central nervous system (CNS), respiratory and oncology. NTEs New Therapeutic Entities - known molecules that are formulated, delivered or used in a novel way to address unmet patient needs. API Active Pharmaceutical Ingredients Integrated R&D Generic and Specialty R&D TGO - Teva Global Operations OTC Over-the-counter medicine joint venture with P&G

5 5 Generics Teva is the number 1 generics company in the world, providing affordable access to medicines for patients and healthcare systems. Leader in the U.S. Leader in Europe Leader in Canada No. 3 in Japan Generics net revenues $9.9 B US 42% ROW 23% Generics net revenues by markets Europe 35% A broad range of basic chemical entities and specialized product families such as sterile products, hormones, narcotics, high-potency drugs and cytotoxic substances More than 400 generic products approved in the U.S. and over 1,000 approved in Europe A leader in quality manufacturing of generics, with state-of-the-art facilities using advanced testing equipment Moving Forward Complex Generics We seek to establish leadership in high-value generics through coordinated global R&D activities, both by pursuing first-to-market opportunities and by developing complex generic products. We will augment our commercial growth strategy in generics with our R&D capabilities in order to sustain our advantages in complex oral and inhalation delivery methods and grow our capabilities in other complex technologies, such as injectables, liposomal drug delivery, long-acting release and others. API Our generics business also includes our world leading API (Active Pharmaceutical Ingredients) manufacturing business - the ingredients that provide the drug with its therapeutic activity. API sales to third parties $692 M We have operations around the globe, producing approximately 300 APIs in many therapeutic areas We produce APIs not only for our own use but also for many other pharmaceutical companies

6 6 Specialty We have a focused and robust global specialty pharmaceutical business Our specialty business focuses on several core franchises, most significantly medicines for central nervous system (CNS) disorders (with a strong emphasis on multiple sclerosis - MS, neurodegenerative disorders, and pain) and respiratory medicines, as well as other areas such as oncology and women s health. Specialty net revenues $8.4 B Europe 20% ROW 8% Specialty revenues by market US 72% Women s health 5% Respiratory 11% Oncology 12% Other specialty 7% Specialty by therapeutic areas CNS 65% We are expanding our pipeline and portfolio in therapeutic areas where we have significant market presence, infrastructure, patient support and know-how In CNS, we have a strong legacy with Copaxone, the leading global treatment for relapsing-remitting multiple sclerosis. In January 2014, the FDA approved Copaxone 40 mg/ml. This formulation will allow for a more convenient dosing regimen of only three times a week Teva global specialty R&D focuses on development of novel specialty products in our key therapeutic areas of CNS and respiratory, with select projects in additional areas, to address unmet patient needs Moving Forward Our strategy is based on building our portfolio and pipeline in therapeutic areas where we have demonstrated strengths, and expanding our presence in related areas through strategic partnerships Our Leading brands CNS Copaxone for relapsing remitting multiple sclerosis Azilect for Parkinson s disease Nuvigil for sleep disorders Oncology Treanda for certain hematological cancers Various biologics for support of cancer patients Respiratory QVAR for the treatment of asthma ProAir HFA, the leading quick relief inhaler for bronchospasm Women s Health Comprehensive portfolio of contraceptive products and others

7 7 OTC - Over the Counter PGT Healthcare - a winning partnership with a world leader - Procter & Gamble PGT in-market sales $1.5 B PGT Healthcare has recorded year over year double-digit growth since its establishment, ahead of the overall OTC market A unique collaboration which combines the core technology and go-to-market strengths of Teva with the consumer understanding and branding strengths of P&G, to develop and commercialize branded OTC medicines Includes the branded OTC medicines of the two companies in categories such as cough/cold and allergy, digestive wellness, vitamins, minerals and supplements (VMS) & analgesics Operates in all markets outside North America, in more than 65 countries New Therapeutic Entities (NTEs) Leveraging our strong capabilities in generics and specialty R&D, Teva is building its NTE development program into a major growth engine for the company Through the NTE program, we are developing late-stage products from known molecules that offer important improvements for patients These advances can lead to better adherence, lower costs and ultimately, better health outcomes To date, we have 14 new NTE products in development, including: > Four abuse deterrent tablets for the treatment of pain > Long-acting injections for the treatment of schizophrenia > Four fixed-dose combinations for the treatment of HIV 250 formulators Teva is unique GENERIC R&D Preclinical development 1000 product files Clinical development 15 complex tech. Global regulatory Proprietary tech. Therapeutic areas knowledge Injectable device dev. SPECIALTY R&D Unprecedented scale Integration of established generic and specialty skills Disciplined process Dedicated resources Combining technological and drug development capabilities in a unique integrated R&D organization

8 8 Teva Global Integrated R&D Our integrated generic and specialty R&D organization is one of our primary competitive advantages Generic R&D Capabilities in a wide range of dosage forms and therapeutic areas as well as in specialized product families and technologies Specialty R&D Clinical development strengths and ability to identify unmet medical needs Maximize our ability to identify and act upon new opportunities Our specialty pipeline Selected pipeline products in clinical development, by therapeutic area and stage: Approved Submitted Phase III Phase II Phase I CNS Respiratory Oncology Women s health Cardiovascular Others

9 9 Teva Global Operations In, Teva produced approximately 64 billion tablets & capsules and over 700 million sterile units We operate 50 pharmaceutical plants in North America, Europe, Latin America, Asia and Israel, with two additional sites currently under construction These plants manufacture solid dosage forms, sterile injectables, liquids, semi-solids, inhalers and medical devices Our two primary manufacturing technologies, solid dosage forms and injectables, are available in North America, Latin America, Europe and Israel In December 2012, we announced a cost reduction program intended to result in $2 billion of savings by the end of We are focusing particular attention on improving our procurement systems by leveraging our purchasing power and improving our production network, supply chain, and resources deployment processes

10 Our markets Teva has evolved into a truly global powerhouse. We operate in 60 countries, and distribute our products all over the world. United States Europe ROW United States net revenues $10.4 B Europe net revenues $6.0 B ROW net revenues $3.9 B Specialty 58% Other 2% Generics 40% Generics 58% Other 14% Specialty 28% Other 25% Specialty 17% by business by business by business Generics 58%

11

12 Investor Relations Kevin Mannix VP, Head of Global Investor Relations Tel: +1 (215) Tomer Amitai Senior Director, Investor Relations Tel: +972 (3) Pharmaceutical Industries Ltd. Corporate Communications Iris Beck Codner SVP, Chief Communications Officer Tel: +972 (3) Corporate Headquarters 5 Basel St., P.O.Box 3190 Petach Tikva , Israel Tel: +972 (3) Fax: +972 (3)