EX-99.1 2 a50725085ex99-1.htm EXHIBIT 99.1 a50725085ex99-1.htm
Exhibit 99.1
 
Slide 1
 Teva R&D in Focus - Respiratory Webinar for the investment communityOctober 8th, 2013
 
 

 
 
Slide 2
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995 This document contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
 
 

 
 
Slide 3
Teva R&D in Focus webinar series
 
 

 
 
Slide 4
Teva R&D in Focus : schedule Other Placeholder: 4  High-value Gx  NTEs  CNS (MS)  Respiratory  October 8, 2013  December 5, 2013  Early 2014  Early 2014
 
 

 
 
Slide 5
Teva R&D Strategy Establish leadership in  High-value Gx  Build a unique platform for  NTEs  Sustain and leverage strengths in   CNS  Achieve leading presence in  Respiratory
 
 

 
 
Slide 6
Teva R&D in Focus - Respiratory: speakers Tushar Shah, M.D.Senior Vice President, Head of Global Respiratory R&D20 years in respiratory R&D roles6 years at Teva, 5 in Altana, 9 at GSK Numerous INDs, 8 NDA submissions (incl. Advair) Hans LuijendijkVice President, Head of Global Respiratory Commercial25 years in sales, marketing, R&D and strategic roles4 years at Teva, 8 at AstraZeneca, 13 at GSK
 
 

 
 
Slide 7
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
 
 

 
 
Slide 8
Teva Respiratory today – the topline A broad-based R&D Strategy: 10 clinical stage programs Targeting all major drug classesProprietary devices addressing unmet needsAB-rated strategy in US13 submissions in next 5 yearsTargeting classes with aggregate value of $20BStrong growth expected: From a $1B franchise today……to a multi-billion $ franchise by end of decade
 
 

 
 
Slide 9
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
 
 

 
 
Slide 10
Teva Respiratory today:  a ~$1B business (excl. generics)  ~$1B 2013E  2012  * Qnasl® in US, local brands in EU  $856M  Qvar®  ProAir®  Other*  Other*  Qvar®  ProAir®
 
 

 
 
Slide 11
(Gp:) #4  Teva: A significant player in respiratory today WW Sales ($)  #5  Source: IMS MIDAS Q2’13 Asthma and COPD ‘R3’, Teva sales excluding generics  US Sales ($)  #4
 
 

 
 
Slide 12
Strong track record in US market Strong brand performance:  ProAir® (with dose counter): #1 in albuterol category (52% share*)Qvar®: #2 in inhaled corticosteroid(ICS) category (28% share*)Qnasl®:  non-aqueous nasal spray for allergic rhinitis (recently launched) An integrated approach: Product differentiation that addresses unmet needsPublished clinical benefitEffective specialty sales force:400 reps, rank equal/better than category leaders (intent to prescribe)Leading payer access, strong pharmacy initiatives * Share of total prescriptions ; Source:  IMS NPA, MAT ending June, 2013
 
 

 
 
Slide 13
Agenda Teva Respiratory today our strategy ICS/LABA class Teva's role R&D approach capabilities pipeline Teva-MicroDose Platform RSV program Commercial implications
 
 

 
 
Slide 14
Our Strategy in Respiratory Enhance value of existing brands (Qvar® and ProAir®): Introduce next-generation based on novel inhalersEnter new high-value drug classes in Asthma/COPD: Launch differentiated products based on novel inhalersExpand geographically: All EU countries, significant ROW marketsEnter adjacent disease areas (e.g. RSV)Launch AB-rated products in US
 
 

 
 
Slide 15
We are developing products in all major drug classes ICS/LABA  Antichol/ ß-agonist  SABA: Short Acting  ß2-AgonistLABA : Long Acting ß2-AgonistICS:  Inhaled Corticosteroids  LAMA : Long-Acting Muscarinic Antagonists  WW market: $32B (12 months ending in Q2/2013)  Source : IMS MIDAS Q2 2013  Reslizumab  ProAir® Spiromax ®  DuoResp® Spiromax®FS Spiromax®FS MDIAB-rated ICS/LABA  Qvar BAIFP Spiromax®AB-rated ICS  LAMA BAIAB-rated LAMA  LAMA  ICS  SABA  Anti-cytokines  LABA
 
 

 
 
Slide 16
Multiple approaches to address unmet needs  Differentiated products based on innovative devices  Novel molecules   AB-rated  Teva-MicroDose  Spiromax®
 
 

 
 
Slide 17
Current inhaled therapy: significant limitations Inappropriate inhaler use(device errors / coordination) Inadequate adherence (% of prescribed doses taken) Reduced effectiveness Patients under-utilize inhaled medicines with negative health outcomes
 
 

 
 
Slide 18
Inappropriate inhaler use: prevalent and associated with poor clinical outcomes Giraud et al. Eur Respir J 2002; 19: 246–251  Asthma Instability Score*  % of the population  n=3709p <0.0001  * Asthma Instability Score is a composite index of: Symptom frequency / Rescue medication / Nocturnal awaking/ Exercise-induced dyspnea / Emergency-care visit / Global perception of evolution  Inappropriate inhaler use  Appropriate inhaler use
 
 

 
 
Slide 19
Improving inhaled therapy - Simpler intuitive inhalers- Consistency across inhalers  - Reduced dosing frequency- Monitoring  Inappropriate inhaler use(device errors / coordination)  Inadequate adherence (% of prescribed doses taken)  PROBLEMS  SOLUTIONS
 
 

 
 
Slide 20
Spiromax®: designed to be simple and intuitive 1 Open  2 Inhale  3 Close  Intuitive  Easy to use  Easy to educate
 
 

 
 
Slide 21
Spiromax® : preferred by patients 21 No preference 65% Preference: Spiromax® vs. Diskus® N=17 71% Preference: Spiromax® vs. Turbuhaler®  N=63 GFK Research, August 2013 (market study conducted in EU, sponsored by Teva)
No preference
 
 

 
 
Slide 22
Device has significant influence on prescribing 22 How would you rank the influence of delivery device over your prescribing decision?* * Pulmonologist survey, Jefferies Research, 2013 1  No impact 6.7 10 Very significant impact "An old but well-known drug in a new, more reliable inhaler is probably more useful than a new drug in an old – flawed - inhaler“** **  Virchow JC, et al. Respir Med 2008; 102:10-19 ; Virchow JC. Respir Med 2004; 98:S28-S34
 
 

 
 
Slide 23
23 Broad use of a single device reduces patient errors 23 Body: Most patients on maintenance therapy also use albuterol (rescue) Using different devices significantly increases errors* We will offer maintenance and rescue medication in similar devices To From  FS Spiromax ®  ProAir® Spiromax® Maintenance (e.g. ICS/LABA)  Reliever/Rescue (Albuterol) + * van der Palen J, et al. Eur Respir J 1999; 14:1034-7 +
 
 

 
 
Slide 24
Agenda Teva Respiratory today Our Strategy ICS/LABA class: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
 
 

 
 
Slide 25
ICS/LABA is the largest respiratory drug class 25  SABA: Short Acting  ß2-Agonist LABA : Long Acting ß2-Agonist ICS:  Inhaled Corticosteroids LAMA : Long-Acting Muscarinic Antagonists Source : IMS MIDAS Q2 2013  ICS/LABA  Antichol/ ß-agonist  LAMA  ICS  SABA  Anti- cytokines  LABA
 
 

 
 
Slide 26
ICS / LABA class: market evolution 26 Differentiated ICS/LABA products will generate significant sales from 2014 No AB-rated Advair® before 2018 Other Placeholder: 26  Differentiated ICS/LABA AB-rated Advair® & Symbicort® (US)  Advair® Symbicort® Foster®, Dulera® (Gp:) $14B (Gp:) 2018 (Gp:) 2013 (Gp:) 2023  Differentiated ICS/LABA  (Breo®/Relvar®, QMF149, Flutiform®,  DuoResp®, FS Spiromax, others) Source: Teva respiratory market model
 
 

 
 
Slide 27
27 Differentiated ICS/LABA DuoResp (EU)Same molecules as Symbicort ® FS Spiromax (US) FS Spiromax  (EU) Same molecules as Advair® 2013 2015 First ICS/LABA Spiromax® submitted in EU2 additional ICS/LABA Spiromax® submissions in 2015 (Gp:) $14B (Gp:) 2018 (Gp:) 2013 (Gp:) 2023 AB-rated Advair® & Symbicort® (US) Advair®Symbicort®Foster®, Dulera® Differentiated ICS/LABA (Breo®/Relvar®, QMF149, Flutiform®,  DuoResp®, FS Spiromax, others)
 
 

 
 
Slide 28
28 (Gp:) 2013 (Gp:) 2023  AB-rated Advair® AB-rated Symbicort® Title: We are developing AB-rated Advair® and Symbicort®, and will submit an AB-rated Advair® in 2017 (Gp:) 2018 (Gp:) 2013 (Gp:) 2023 Advair® Symbicort® Foster®, Dulera® AB-rated Advair® & Symbicort® (US) Differentiated ICS/LABA (Breo®/Relvar®, QMF149, Flutiform®,  DuoResp®, FS Spiromax®, others)
 
 

 
 
Slide 29
29 Summary We are targeting key opportunities in ICS/LABA Unmet medical needs addressed via proprietary devices Focused AB-rated strategy in the US Similar approach in key existing and emerging classes (ICS, LAMA, LAMA/LABA, etc.) 29 T
 
 

 
 
Slide 30
Agenda Teva Respiratiory today Our strategy ICS/:ABA market: Teva's role R&D approach: Capabilities, pipeline MicroDose: Platform, RSV program Commercial implications 30
 
 

 
 
Slide 31
31 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 31
 
 

 
 
Slide 32
 
32 Capabilities Leading MDI manufacturer globally: 55 million units/yr Global respiratory R&D site network: 250 employees, $100M’s invested in infrastructure Unique skill set in CMC, Clinical, Regulatory Recent track record: QNASL® – FDA approval (one review cycle) ProAir® dose counter – FDA approval (one review cycle) DuoResp® Spiromax®– EU submission
 
 

 
 
Slide 33
33 Title: Deep pipeline: 10 clinical programs ; 5 in Phase II, III Other Placeholder: 33 * BAI : breath actuated inhaler – designed as simple and intuitive device based on MDI DuoResp Spiromax Asthma, COPD ProAir Spiromax QVAR BAI Reslizumab Fluticasone Propionate Spiromax Salmeterol MDI 2:1 1:1 LAMA BAI Teva-Microdose MDT637 RSV preclinical programs AB-rated products for US market Multiple 4 2 3 1 Pre-Clinical Phase i Phase ii Phase iii Filed
 
 

 
 
Slide 34
34 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 34
 
 

 
 
Slide 35
35 Title: R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines 35
 
 

 
 
Slide 36
36 DuoResp® Spiromax® Other Placeholder: ICS/LABA - maintenance therapy Same molecules as Symbicort®(Budesonide/Formoterol) Intuitive Spiromax device with dose counter Achieved bioequivalence according to EU guidelines Submitted in EU in 1/2013 (centralized procedure) Other Placeholder: 36
 
 

 
 
Slide 37
37 Title: DuoResp® Spiromax®: bioequivalence to Symbicort® achieved in all parameters Other Placeholder: 37  0.80 1.25 1.060.96 0.80 1.25 1.12 0.98 0.80 1.25 1.05 0.98 0.80 1.25 1.16 0.98 0.80 1.251.01 0.91 0.80 1.251.08 0.96 0.80 1.25 1.02 0.94  0.80  1.25  1.04  0.95  Bioequivalence interval  PK ratio and 90% CI of Spiromax to Symbicort® (320/9 dose)  Budesonide  Formoterol  Lung absorption  Total absorption  AUC0-last  Cmax  AUC0-last  Cmax  L. Weisfeld, et al.  Oral Presentation. ERS 9/2013 Slide: 38 Title:  Spiromax®: preferred by physicians vs. Turbuhaler®
 
 

 
 
Slide 38
 
38 Spiromax®: preferred by physicians vs. Turbuhaler® 38 76% Undecided N=181 Which is a better device? GFK Research, August 2013 (market study conducted in EU, sponsored by Teva)
 
 

 
 
Slide 39
 
 
 
 

 
 
Slide 40
 
39 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines 39
 
 

 
 
Slide 41
41 Title: ProAir® Spiromax® - Status Other Placeholder: Successfully completed Phase I and II studies Completing Phase III (four clinical trials) and two pediatric phase 1 and 2 trials this year NDA submission under 505(b)(2): Mid-2014 41
 
 

 
 
Slide 42
 
42 R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiormax® ProAir® Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder:
 
 

 
 
Slide 43
43 FS Spiromax® Other Placeholder: ICS/LABA - maintenance therapy Same molecules as Advair® (Fluticasone/Salmeterol) Intuitive Spiromax device with dose counter Device consistency with rescue medication Improved therapeutic index demonstrated in Phase II 43
 
 

 
 
Slide 44
 
44 300 200 100 0 Data on file, Teva Pharmaceuticals Time (hr) Baseline-adjusted FEV1 (mL) 0.5 1 2 3 4 5 6 9 12 Salmeterol 5 different salmeterol doses  in FS Spiromax® (fluticasone/salmeterol) administered : Salmeterol component increasing: 0, 6.25, 12.5, 25, 50 mcg Fluticasone component was constant (100 mcg) in all 5 doses Improvement in lung function (FEV1) was measured 12 hours following admin. 12.5 mcg 25 mcg 6.25 mcg 0 mcg 50 mcg
 
 

 
 
Slide 45
 
45 45 300 200 100 0 Data on file, Teva Pharmaceuticals Time (hr) Baseline-adjusted FEV1 (mL) 0.5 1 2 3 4 5 6 9 12 FS Spiromax® 100 mcg fluticasone /12.5 mcg salmeterol Advair® 100 mcg fluticasone /50 mcg salmeterol Title: FS Spiromax® provided similar bronchodilation with four-fold lower salmeterol dose compared to Advair® Trial also included one dose of Advair®: 100 mcg fluticasone / 50 mcg salmeterol
 
 

 
 
Slide 46
 
46 FS Spiromax®: same effective dose - 40% of the systemic exposure Other Placeholder: 46  = 0.4 *systemic exposure : AUC [0-t] pg hr/mL  Systemic exposure*….  FS Spiromax® 100 mcg fluticasone /12.5 mcg salmeterol
 Advair® 100 mcg fluticasone /50 mcg salmeterol (40%)
 
 

 
 
Slide 47
47 FS Spiromax®: Improves lung delivery     Same clinical effect as Advair® achieved with significantly lower dose  Leading to less systemic exposure  Improved therapeutic index Other Placeholder: 47
 
 

 
 
Slide 48
 
Title: FS Spiromax® - Status Other Placeholder: Initiating Phase III early 2014 NDA submission under 505(b)(2) in 2015 Other Placeholder: 48
 
 

 
 
Slide 49
Title: R&D Approach Other Placeholder: Capabilities, track record, pipeline Deep-dive into 3 programs: DuoResp® Spiromax® ProAir®Spiromax® FS Spiromax® Perspective on draft FDA guidelines Other Placeholder: 49
 
 
 

 
 
Slide 50
Title: New FDA draft guideline removes a key obstacle to approval of AB-rated Advair® Other Placeholder: 50 Dose response pharmaco-dynamics DOABLE Single 4-week bioequivalence study HIGHLY CHALLENGING Prior requirements Draft Guideline
 
 

 
 
Slide 51
Title: Rest of guideline remain the same Other Placeholder: 51
 
 

 
 
Slide 52
Title: Developing AB-rated products will still be difficult Other Placeholder: 52 Body: CMC challenges: Developing a new dry powder device that matches Diskus® Demonstration of robust stability Need to achieve this at commercial scale PK and PD bioequivalence challenges In EU, slightly simpler guidelines in place > 4 years: Numerous attempts to develop generics by many companies Multiple failures / setbacks No successful development to date by a major company We anticipate first US launch by others in 2018
 
 
 

 
 
Slide 53
We are aggressively developing an AB-rated Advair® Other Placeholder: 53 Based on internally developed blister-based device Expected to meet FDA guidelines for comparability to Advair Diskus®  Leverage our considerable expertise and knowledge Working with fluticasone, salmeterol, and lactose Developing and manufacturing dry powder devices Conducting PK Bioequivalence and clinical asthma trials  Submission planned for 2017
 
 
 

 
 
Slide 54
Teva is perfectly situated to succeed in AB-rated respiratory products Multiple programs underway: AB-rated Advair® AB-rated Symbicort® Others
 
 
 

 
 
Slide 55
Teva Respiratory today Our strategy ICS/LABA market: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
 
 
 

 
 
Slide 56
Nebulizers: used to treat the young and the elderly Other Placeholder: 56 Inhalers (Gp:) Nebulizers Young children & the elderly More able patients
 
 
 

 
 
Slide 57
Current nebulizers have significant limitations Other Placeholder: Considerable effort to prepare dose Long dosing time (5-20 minutes) No feedback Inefficient and inexact dosing Large and bulky Most use mains electricity Cleaning is cumbersome Other Placeholder: 57
 
 
 

 
 
Slide 58
Teva-MicroDose is designed to be a unique type of nebulizer Other Placeholder: 58 Other Placeholder: Dose preparation not needed Fast  dosing: 30 seconds Feedback (LED) Exact and efficient dose Battery operated Small and portable Remote monitoring Easy to clean
 
 
 

 
 
Slide 59
Teva-MicroDose : preferred delivery modality for young children and the elderly Other Placeholder: 59  Inhalers Young children & the elderly More able patients Teva-MicroDose Physicians surveyed* would switch to a Teva-MicroDose device: 77% of their poorly-controlled patients currently on nebulizer 46% of their well-controlled patients currently on nebulizer * National Analysts Worldwide, Global survey, Fall 2012,  81 MDs
 
 
 

 
 
Slide 60
Inhalers Young children & the elderly More able patients Title: Teva-MicroDose: potential to be a preferred device for some patients currently treated with inhalers Teva-MicroDose * National Analysts Worldwide, Global survey, Fall 2012,  81 MDs Physicians surveyed* would switch to a Teva-MicroDose device: 72% of their poorly-controlled patients currently on inhaler 29% of their well-controlled patients currently on inhaler
 
 
 

 
 
Slide 61
Pipeline based on Teva-MicroDose device Other Placeholder: MDT637 (RSV) - enters phase II Multiple pre-clinical programs 61
 
 
 

 
 
Slide 62
Respiratory Syncytial Virus (RSV): a large unmet need Other Placeholder: A major disease in young children Most frequent cause of hospitalization of infants and young children in industrialized countries 85 000 to 144 000 RSV-associated hospitalizations of infants in US each year A major problem in COPD patients 14 000 to 62 000 RSV-associated hospitalizations of the elderly in US each year Cause of 160 000 deaths globally each year Ribavirin is only approved treatment Minimal use due to limited efficacy, side effects 62 Source: World Health Organization, Acute Respiratory Infections (2009)
 
 
 

 
 
Slide 63
MDT637 Small molecule targeting the RSV fusion protein Delivered to lungs in Teva-Microdose device Developed for treatment of RSV infection in infants Potential additional indications to study: Prophylaxis in infants Elderly (primarily COPD patients) 63
 
 
 

 
 
Slide 64
Antiviral activity demonstrated in a highly predictive preclinical model Cotton rats inoculated on Day 0 ; viral titers assessed on Day 4 MDT637 reduced viral load by 2.3 log1
In comparison, ribavirin reduced viral load by 1.25-1.35 log in same model2 64 1. Antiviral Res. 2005; 68: 18-26. Data for RSV Long Stain shown. 2. Antiviral Res. 1987; 7(4): 211-220 (Gp:) Placebo (Gp:) Day 0 (QD) (Gp:) Day 0 (BID) (Gp:) Day 1 (BID) (Gp:) Day 1 (2X BID) (Gp:) Day 0-3 (QD) (Gp:) Dosage Scheme (Gp:) RSV viral titer (TCID50 Log10/g Lung (Gp:) P<0.05 (Gp:) P<0.01 (Gp:) P<0.01 (Gp:) 2.1 Log (Gp:) 2.3 Log (Gp:) 2.3 Log (Gp:) Limit of  detectable reduction (2.3 log reduction) RSV B (Washington/18537/’62) shown to have equivalent sensitivity to MDT-637
 
 
 

 
 
Slide 65
Phase 1 program successfully concluded Low systemic exposure No pulmonary adverse events No clinically significant changes in pulmonary function, ECG, laboratory values, vitals or physical exam  65  Single Ascending Dose (Healthy)  Multiple Ascending Dose (Healthy)  Single Ascending Dose (Asthmatics)  No significant adverse events in all 3 studies: Effective doses achieved and sustained Drug levels quantified 15 min., 6 and 24 hours post dose All >RSV IC50
 
 
 

 
 
Slide 66
MDT-637 : next steps Phase 2a studies to begin in 4Q3013 NDA submission 2017 66
 
 
 

 
 
Slide 67
Summary Strong capabilities and infrastructure Deep pipeline: 10 clinical stage programs Spiromax® : significant clinical data, platform validated Teva-MicroDose: game changing platformfor children & elderly AB-rated Advair®: submission in 2017 67
 
 
 

 
 
Slide 68
Teva Respiratory today Our strategy ICS/LABA market: Teva's role R&D approach: Capabilities, pipeline Teva-MicroDose: Platform, RSV program Commercial implications
 
 
 

 
 
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5 years ; 13 submissions 69 2013 2014 2015 2016 2017 DuoResp Spiromax (EU) Advair AB-rated (US) FS MDI (EU) FS Spiromax (EU) FS Spiromax (US) ICS / LABA ProAir Spiromax (US)
 SABA Fluticasone Spiromax (US) Qvar BAI (US) ICS LAMA BAI (US) LAMA BAI (EU) LAMA Microdose RSV Reslizumab IV Reslizumab SC New classes
 
 
 

 
 
Slide 70
Expected total respiratory revenue 70 $1B $2B $4B Today (2013) In 5 years (2018) In 10 years (2023) $1B $2B $4B Currently marketed brands + pipeline
 
 
 

 
 
Slide 71
R&D in Focus: Respiratory – the bottom line A broad-based R&D Strategy: 10 clinical stage programs Targeting all major drug classes Proprietary devices addressing unmet needsAB-rated strategy in US 13 submissions in next 5 years Targeting classes with aggregate value of $20B Strong growth expected: From a $1B franchise today. to a multi-billion $ franchise by end of decade 71
 
 
 

 
 
Slide 72
 
Thank you