Ted Quiroz Director, Global Clinical Supply Chain Amgen Inc.
to serve patients Enbrel (etanercept) EPOGEN (Epoetin alfa) Aranesp (Darbepoetin alfa) Sensipar (cinacalcet HCl) Vectibix (panitumumab)
We aspire to be the best human therapeutics company. We will live the Amgen values and use science and innovation to dramatically improve people s lives. Our Goals Deliver the Best Pipeline- Corporate Build the Best Pipeline- Operations Supply Every Patient Every Time- Operations
How does a company develop 28 therapies, conduct over 200 clinical trials, serve over 40,000 patients, in 48 countries?
& $ (!! " $ ( ( % $ ' $ # & $ $ % " # "!!! Phase 1 ( & % $ $ -. - ( &! $ ( # #! $ ( * * + & ", " # * * " # # * * )! ) Phase 2! %! $ ( & ' (! %! %!# ) " # # Phase 3
! " Clinical trials entering unfamiliar, recently developing infrastructures Fierce competition for enrolling new patients globally Sustaining cold or frozen shipments through multi-connection international locations The movement of biologics differs significantly compared to small molecule Ambient products are easier to move- Maintaining temperature is critical Less concern about shock and vibe- Proteins are more sensitive Stability profile takes longer to establish Transport validation potentially complex, nontransparent lanes Safely securing comparator products through international sources Keen global partner management tactics Coordination across opposite time zones Awareness of cultural differences Infrastructure- Limited presence globally
In our company, Global Clinical Supply Chain Management plays a key role in coordinating and managing the variables related to Amgen s pipeline from concept to delivery Gather requirements with R&D- Review demand and set forecasts Plan overall study needs- Pre-clinical and Clinical Build inventories working with Manufacturing Define label and packaging needs Work with partners to ensure delivery of product Transportation Distribution Provide ongoing Support- Customer Service Systems- IVR set up, testing and issue management Reconciliation Manage daily activities with depots in LA, Asia, and NA Clinical Supply Chain Management plays an expanded role compared to traditional roles from other companies
# $ " " %& ' With entry into new countries, it is critical to define the supply chain needs To manage multiple countries, multiple products, different country requirements Solution: Develop cross Functional Study Teams Aligned through therapeutic areas and products Global Regulatory Affairs provides critical information per country Transportation lanes- Qualification process Preferred vendors versus in country expertise ImportExport needs Dedicated experts In country experts- consultants and CROs Utilize vendors that best meet your need- Expertise still emerging Cold Chain Reliability- Fully understand cold chain products Demonstrate competency to reduce product risk- Contingency planning Execute accurate, detailed contracts with vendors- KPIs Note: Rapid growth can lead to missing the details
$ " " %& ' Competition for new patients globally- Enter new countries quickly and efficiently Expanded label content In-house labeling and packaging operations Amgen Distribution Centers Master service agreements Movement of Refrigerated and Frozen drug product Transport validation- Robust testing program Transport Packaging Configurations- Manufacturing in global locations Provide packaging materials to support trials- depots or LSPs Securing Comparators globally Source local when possible- Improve distribution lead times and costs Minimize re-labeling when possible Ensure blinding strategy can be supported- 2-8 C versus ambient pack outs Partner relationships Infrastructure- Expand presence globally through partners Time zone differences- Meet partners regularly Cultural differences- Understand the do s and don ts
Back up
' Be science-based Compete intensely and win Work in teams Create value for patients, staff, and stockholders Trust and respect each other Ensure quality Collaborate, communicate, and be accountable Be ethical
(" 1980: 1985: 1991: 1994: 2002: 2005: Amgen founded (original name: AMGen) NEUPOGEN (Filgrastim) discovered NEUPOGEN launched, named Product of the Year by Fortune Magazine Amgen receives US Department of Commerce National Medal of Technology Neulasta (pegfilgrastim) launched Amgen acquired Immunex, including ENBREL Kepivance (palifermin) launched 1980 1985 1990 1995 2000 2004 1983: 1989: 2001: 2004: IPO (Ticker Symbol: AMGN) EPOGEN (Epoetin alfa) discovered Enbrel (etanercept) discovered by Immunex EPOGEN launched, named Product of the Year by Fortune Magazine Aranesp (darbepoetin alfa) launched Sensipar (cinacalcet HCl) launched Tularik acquisition completed
( This presentation contains forward-looking statements that are based on management s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of January 25, 2007 and expressly disclaims any duty to update information contained in this presentation. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company s results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign), difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. This presentation includes GAAP and non-gaap financial measures. In accordance with the requirements of SEC Regulation G, reconciliations between these two measures, if these slides are in hardcopy, accompany the hardcopy presentation or, if these slides are delivered electronically, are available on the Company's website at www.amgen.com within the Investors section.