JP Morgan Healthcare Conference
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1 January 8, 2008 JP Morgan Healthcare Conference Kevin Sharer CEO
2 Safe Harbor Statement 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 8, 2008 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 payers, 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 healthcare 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 within the Investors section. 2
3 One Year Ago, We Were in a Good Spot $100 $90 Amgen Stock Price $14 Amgen Revenue and Adjusted EPS* CAGR ($ Billions, except EPS) Revenue 29% $14.2 Adj. EPS* 27% $80 $75.85 $12 $10.6 $70 $10 $60 $8 $50 $6 $5.5 $40 $4 $3.90 $2.40 $30 $2 $1.39 $20 Jan-02 Jan-03 Jan-04 Jan-05 Jan-06 Jan *Adjusted EPS is a non-gaap financial measure and excludes for the applicable periods, restructuring charges, impact of expensing stock options, and various other expenses if this slide is in hardcopy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: within the Investors section. 3 $0
4 2007 Was a Difficult Year Amgen Stock Price Amgen P/E Ratio* $80 17 $75 $70 $65 $60 $55 $50 $45 $40 Jan-07 Apr-07 Jul-07 Oct Jan-07 Apr-07 Jul-07 Oct-07 *P/E calculated using monthly historical 2007 adjusted EPS from First Call consensus 4
5 Safety Related Concerns and Actions Took Their Toll on ESA Revenue $ Billions $2.0 $1.6 $1.6 $1.4 US Aranesp Oncology US Aranesp Nephrology International Aranesp EPOGEN $1.2 $0.8 $0.4 $ Q Q3 ESA = Erythropoietin Stimulating Agent 5
6 However, We Took Decisive and Effective Actions to Protect EPS and Fund and Advance the Pipeline Reduced staff by 13% Cut operating expenses and reduced capital expenditures Sought partners for marketed and pipeline products, including denosumab in Japan Continued outreach efforts 6
7 We Are Working With Regulatory Agencies to Explore the Benefit/Risk Balance of our ESA Franchise New labeling Pharmacovigilance program Full transparency Two FDA advisory panels in 2007 and one planned in
8 Despite the Unexpected Hit to Operating Income We expect 2007 adjusted EPS* to be above our current guidance ($ ) and close to the low end of our initial 2007 adjusted EPS guidance range ($ ) We successfully advanced the pipeline Vectibix registered in Europe K-RAS insights Committed 13 new molecules to development two from outreach efforts Acquired two companies Alantos and Ilypsa *Adjusted EPS is a non-gaap financial measure and excludes for the applicable periods, restructuring charges, impact of expensing stock options, and various other expenses if this slide is in hardcopy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: within the Investors section. 8
9 2008 Is Full of Challenges and Opportunities ESA dialogue continues NCD restricts physician discretion in Medicare more than label Biosimilars in Europe will play out Denosumab PMO data will emerge We will advance ten molecules into mid-stage clinical trials We will continue to seek pipeline partners and pursue our outreach program NCD = National Coverage Determination PMO = Post-Menopausal Osteoporosis 9
10 So, How Does the Business Look Right Now? ESA revenue stable, but ESA dialogue not over and 2008 will bear the full year impact Remaining products at or slightly above our October year-end internal projections Cost actions implemented effectively We will be prepared for whatever comes our way Today, we can provide a bit of 2008 cost context Revenue and adjusted EPS guidance to be provided at a later date 10
11 Here Is Some 2008 Cost Context Outlook for adjusted expenses* On track to deliver announced restructuring cost savings COGS as a percent of sales will be similar to Q3 07 R&D as a percentage of sales will decline slightly versus 2006 levels SG&A excluding the Wyeth profit share is expected to be slightly lower than 2006 Due to increased Enbrel sales, Wyeth profit share is expected to be ~ 1/3 of SG&A in 2008 vs ~ 1/4 in 2006 *Adjusted EPS is a non-gaap financial measure and excludes for the applicable periods, restructuring charges, impact of expensing stock options, and various other expenses if this slide is in hardcopy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: within the Investors section. 11
12 Our 2008 Focus Work with FDA and EMEA on ESA label and safety exploration/assessment Keep shareholder value creation as a top priority Operate the business to optimize financial results 2007 was a real lesson in how to do it Advance and enrich the pipeline with particular focus on denosumab Motivate, challenge, and retain our top talent Communicate with shareholders often, openly, and responsively FDA = Food and Drug Administration EMEA = European Medicines Agency 12
13 January 8, 2008 JP Morgan Healthcare Conference Kevin Sharer CEO
14 Reconciliations
15 Reconciliation of GAAP Earnings (Loss) Per Share to "Adjusted" Earnings Per Share (Unaudited) Results for the years ended December 31, GAAP earnings (loss) per share $ 1.03 $ (1.21) $ 1.69 $ 1.81 $ 2.93 $ 2.48 Adjustments to GAAP earnings (loss) per share: Write-off of acquired in-process research and development (a) (a) (a) Amortization of acquired intangible assets, product technology rights (b) 0.17 (b) 0.16 (b) 0.17 (b) 0.17 (b) Stock option expense (c) Amortization of acquired intangible assets, R&D technology rights (d) Impairment of non-enbrel related intangible asset (e) Other merger-related expenses (f) 0.04 (f) 0.02 (f) 0.01 (f) 0.02 (f) Write-off of manufacturing asset Tax liability related to repatriation of certain foreign earnings Legal settlements awards and cost recoveries - (0.12) (0.02) (0.01) Amgen Foundation contribution Termination of collaboration agreements 0.12 (0.03) Other Adjustment for interest expense on convertible notes (g) "Adjusted" earnings per share $ 1.18 $ 1.39 (h) $ 1.90 $ 2.40 $ 3.20 $ 3.90 Notes: (a) To exclude the non-cash expense associated with writing off the acquired in-process (f) To exclude, for the applicable periods, merger related expenses incurred due to the research and development related to the acquisitions of Abgenix, Inc. ("Abgenix") and acquisitions of Abgenix, Avidia, Tularik and Immunex, primarily related to incremental Avidia, Inc. ("Avidia") in 2006, Tularik, Inc. ("Tularik") in 2004 and Immunex Corporation costs associated with retention, integration and/or recording inventory acquired at ("Immunex") in fair value which is in excess of our standard cost. (b) To exclude the ongoing, non-cash amortization of acquired intangible assets, primarily (g) Pursuant to the if-converted method of calculating EPS, the numerator for "Adjusted" ENBREL, related to the Immunex acquisition. EPS in 2002 reflects the avoidance of interest expense incurred, net of tax, related to (c) To exclude the impact of stock option expense recorded in accordance with Statement of the assumed conversion of the convertible notes due in 2032 ("2032 Convertible Notes"). Financial Accounting Standards ("SFAS") No. 123R. Effective January 1, 2006, Amgen The conversion of such debt and the avoidance of interest expense is not assumed for adopted SFAS No. 123R. calculating the GAAP EPS because its impact is anti-dilutive due to the GAAP net loss in (d) To exclude the ongoing, non-cash amortization of the intangible asset, XenoMouse (h) Due to the GAAP net loss in 2002, shares used in calculating the GAAP loss per share technology, acquired with the Abgenix acquisition. exclude the impact of stock options and convertible notes because their impact was (e) To exclude the impairment of a non-enbrel related intangible asset previously acquired anti-dilutive. Shares used in calculating the '"Adjusted" earnings per share for 2002 in the Immunex acquisition. include the impact of dilutive stock options (27 million shares) and 2032 Convertible Notes (29 million shares) under the treasury stock and "if-converted" methods, respectively. 15
16 Amgen Inc. Reconciliation of "Adjusted" Earnings Per Share Guidance to GAAP Earnings Per Share Guidance for the Year Ending December 31, 2007 "Adjusted" earnings per share guidance - excluding stock option expense... (a) $ $ 4.23 Known adjustments to arrive at GAAP earnings: Restructuring costs... (b) (0.51) - (0.53) Write-off of Alantos and Ilypsa acquired in-process research & development... (c) (0.53) Amortization of acquired intangible assets, product technology rights... (d) (0.16) Stock option expense... (e) (0.10) - (0.12) Tax settlement... (f) 0.08 Write-off of excess inventory... (g) (0.07) Amortization of acquired intangible assets, R&D technology rights... (h) (0.04) Write-off the cost of a semi-completed manufacturing asset... (i) (0.03) Write-off of deferred financing and related costs... (j) (0.03) Other merger-related expenses... (k) (0.02) GAAP earnings per share guidance... $ $ (a) (b) (c) (d) On January 8, 2008, the Company stated that it expects 2007 adjusted earnings per share ("EPS") to be above its previously announced (October 24, 2007) guidance range of $ $4.23, and close to the low end of the Company's January 25, 2007 adjusted EPS guidance of $ $4.50, excluding stock option expense and certain other expenses. To exclude restructuring related costs including asset impairment charges, accelerated depreciation, loss accruals for certain leases and staff separation costs. To exclude the non-cash expense associated with writing-off the acquired IPR&D related to the acquisitions of Alantos Pharmaceuticals Holding, Inc. ("Alantos") and Ilypsa, Inc. ("Ilypsa"). To exclude the ongoing, non-cash amortization of acquired product technology rights, primarily ENBREL, related to the Immunex acquisition. (e) To exclude the estimated stock option expense associated with Amgen's adoption of SFAS No. 123R. (f) (g) (h) (i) (j) (k) To exclude the income tax benefit recognized as the result of resolving certain non-routine transfer pricing issues with the Internal Revenue Service for prior periods. To exclude the write-off of inventory principally due to changing regulatory and reimbursement environments. To exclude the ongoing, non-cash amortization of the Research & Development technology intangible assets acquired with the Abgenix and Avidia acquisitions. To exclude the impact of writing-off the cost of a semi-completed manufacturing asset that will not be used due to a change in manufacturing strategy. To exclude the pro rata portion of the deferred financing and related costs that were immediately charged to interest expense as a result of certain holders of the convertible notes due in 2032 exercising their March 1, 2007 put option and the related convertible notes being repaid in cash. To exclude other merger related expenses incurred due to the Tularik, Abgenix, Avidia, Alantos and Ilypsa acquisitions. 16
17 Amgen Inc. Reconciliation of GAAP to "Adjusted" Cost of Sales (In millions) (Unaudited) Three Months Ended September 30, 2007 GAAP COS Adjustments "Adjusted" COS Cost of sales ("COS") (excludes amortization of acquired intangible assets)... $ 792 $ (4) (a) $ 585 (113) (b) (90) (c) (a) To exclude the impact of stock option expense recorded in accordance with SFAS No. 123R. (b) The following table summarizes the (expense)/income amounts impacting COS related to the restructuring plan: Separation costs... $ 1 Asset impairment... (4) Accelerated depreciation... (110) Total... $ (113) To exclude the reversal of previously accrued expenses for bonuses and stock-based compensation awards, which was forfeited as a result of the employees' termination. To exclude asset impairment charges incurred in connection with the rationalization of our worldwide manufacturing operations. To exclude accelerated depreciation resulting from our decision to accelerate the closure of one of our ENBREL commercial bulk production operations in connection with the rationalization of our worldwide network of manufacturing facilities. The amount represents the excess of accelerated depreciation expense over the depreciation that would otherwise have been recorded if there were no plans to accelerate the closure of this manufacturing operation. (c) To exclude the write-off of inventory principally due to regulatory and reimbursement developments. 17
18 Amgen Inc. Reconciliation of Selected GAAP Operating Expense Amounts to "Adjusted" Amounts (In millions) (Unaudited) Year Ended December 31, 2006 GAAP Adjustments "Adjusted" Selected operating expenses: Research and development... $ 3,366 $ (104) (a) $ 3,191 (16) (b) (48) (c) (7) (d) Selling, general and administrative... 3,366 (120) (a) 3,234 (7) (b) (4) (d) (1) (e) (a) To exclude the impact of stock option expense recorded in accordance with SFAS No. 123R. (b) To exclude merger related expenses incurred due to the Abgenix acquisition, primarily related to incremental costs associated with retention and/or recording inventory acquired at fair value which is in excess of our standard cost. (c) To exclude the ongoing, non-cash amortization of the intangible asset, XenoMouse technology, acquired with the Abgenix acquisition. (d) To exclude merger related expenses incurred due to the Tularik Inc. acquisition, primarily related to incremental costs associated with retention and/or integration. (e) To exclude merger related expenses incurred due to the Avidia acquisition, primarily related to incremental costs associated with integration. 18
19 January 8, 2008 JP Morgan Healthcare Conference Kevin Sharer CEO
Other revenues Total revenues... 3,751-3,751 3,745-3,745
Condensed Consolidated Statements of Income and Reconciliation of GAAP Earnings to "Adjusted" Earnings (In millions, except per share data) Three Months Ended Three Months Ended December 31, 2008 December
More informationTotal revenue increased 15 percent during the first quarter of 2007 to $3,687 million versus $3,217 million in the first quarter of 2006.
Apr. 23, 2007 Amgen's First Quarter 2007 Revenue Increased 15 Percent to $3.7 Billion Amgen's First Quarter 2007 Adjusted Earnings Per Share (EPS) Increased 19 Percent To $1.08 First Quarter 2007 GAAP
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