Growth and Success through Partnering & Outsourcing

2 Teva Salt Lake City- Contract Manufacturing Capability: Purpose: The Teva Salt Lake City (SLC) facility is considered a specialty manufacturing facility that partners with a variety of pharmaceutical companies who utilize the organization as a contract manufacturing organization (CMO). Background: SLC manufactures products as Prescription(Rx), Generic(GRx), and Over the Counter(OTC). Many of the top 10 pharmaceutical companies utilize Teva Salt Lake City to manufacture their products. Contract / partner manufacturing can build relationships between competing pharma companies in order to:  Decrease COGs  Increasing FTM opportunities  Reduce risk

3  Overview  Benefits  Manufacturing for the Competition  Risks  Regulations Agenda

4 Overview  Why do companies use contract manufacturing organizations  Big Pharma companies are consolidating  End of blockbuster drugs  Personalized medicine  Plant closings  Elimination of R&D  The FDA seems to be overwhelmed and is now becoming more risk averse  PDUFA V 2012:  Communication availability between applicants and the FDA review team  Additional review time for the agency to meet with applicants  Assessments will evaluate parameters that have an have not achieved the product goals  GDUFA I 2014:  Complete response letters to be provided to the applicant  Division level deficiency review  Prompt communication of easily correctable deficiencies  First cycle post complete response meetings  Expedited PIV (day 1 submissions)

5 Overview  The more risk averse the big pharma companies become the more they need good partners.  Reduces the risk of a failing product with their name on it  Technical resources (such as: quality, regulatory, etc) are more available and specialized  Pharma companies can do more with less  The Blockbuster Drug Pipeline is coming to an end  Companies are looking for ways to extend patents, brand recognition, and new indications for existing products  Small / Specialty pharma companies do not want to invest in production capability  High risk / high reward models  Focus to create a unique drug / drug delivery IP

6  Overview  Benefits  Manufacturing for the Competition  Risks  Regulations Agenda

7 Benefits  Advantages of Contract Manufacturing  Partners have no capital expenditure for plant or equipment  Flexibility. Products are based on current business trends.  Diversification. Big pharma companies tend to work with multiple CMOs which provides flexibility  The CMOs perform the “mundane” operations whereas the management team from the partner can focus on alternate activities.  Specialization of the CMO and resources / equipment  CMOs help minimize risks and uncertainty with partners who they trust that can bring something novel to market.  CMOs have expertise in the technical arena which can assist in product / manufacturing navigation  CMOs have ~60% less reduced risk of RTRs from worldwide agencies  The collective understanding / learning of CMOs involve how to coordinate diverse production skills and integration of multiple technologies.  Teva SLC takes these new technologies to a new level for our partners.  The products manufactured in SLC are new markets / delivery systems for 90%+ of our partners

8  Overview  Benefits  Manufacturing for the Competition  Risks  Regulations Agenda

9 Manufacturing for the Competition In House Manufacturing Contract Manufacturing Product Knowledge Base Manufacturing Capabilities Improving Value Reduction of COGs

10  Provides a stable revenue  No need to control critical market fluctuations  Unpredictable volumes / markets are not considered during manufacturing forecast  Activities are contractually agreed upon prior to execution  Innovation and CMO capabilities are enhanced in key areas and not focused on a broader scope / market  The solid dosage market is expected to expand over the next five years at an annual rate of 12.5% and as much as $55 billion will be spent by 2017 on CMO-based solid dosage manufacturing. 1 Manufacturing for the Competition 1 The Benefits of Contract Manufacturing. Pharmaceutical Online 25 Oct 2012.

11  Overview  Benefits  Manufacturing for the Competition  Risks  Regulations Agenda

12 Risks  Lack of control  CMOs are dependent on the customers and their marketing campaigns in order to impact volume  Project successes are difficult to predict  CMOs can meet all project demands and a pharma company can cancel the product  Being reactive rather than proactive  You must react to customer requests  Timing  Delivery schedules  International markets  Audits  CMOs must manage multiple organizational demands from the partners. Sometimes the quality group doesn’t communicate with their own technical team, etc…  Protection of our technology  Our facility has highly technical equipment to manufacture our specialty products.  Cost efficient processes to ensure profitability to the company  Potential competition for Teva brand product  Utilization of skilled resources for the competitor market  Sustaining skilled employees and keeping them

13  Overview  Benefits  Manufacturing for the Competition  Risks  Regulations Agenda

14 Regulations  The FDA created a draft guidance:  Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements  The guidance applies to the commercial manufacturing of APIs, intermediates, finished drug products, combination products, and biological drug products.  It defines the who and what of contract manufacturing  Establishes quality agreement requirements  A comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units for each party involved.  Identifies roles and responsibilities

15 Regulations  The CMO is responsible for maintaining compliance at all necessary markets & regulatory authorities.  Example: if the product is to be marketed in Korea, the KFDA will audit the CMO not the partner  The CMO will be audited by the partners in order to ensure compliance as well.  Most pharma companies have internal quality audit teams that visit CMOs to identify critical / major / minor issues prior to the regulatory agency arriving on site.  CMOs standards and criteria with regulatory agencies are heightened due to the varying products and potential impact if there is a compliance issue.

16 Future  The future for the Teva SLC site is bright!  The SLC facility has on-going development activities with partners as addressed throughout the presentation as well as Teva brand products.  The SLC facility is also engaged with the Teva Specialty products  The SLC facility is also getting ready with the manufacturing of First to file PIV GRx products  The SLC facility is also engaged in bringing new unique technologies to the site for Teva future products  The site is currently engaged with the long term master plan

17 Contact Information Habib Nasirullah- Site General Manager SLC: