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 statements about the planned
completion of the tender offer and the merger, 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 May 8, 2012 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) and 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. Our business performance could affect or limit the ability of our Board of
Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
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 hard copy, accompany the hard copy presentation or, if these slides are delivered
electronically, are available on the Company's website at www.amgen.com within the Investors section.
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 2
3. 2012 Is Off to a Strong Start
• Record first quarter for both revenues and adjusted EPS*
• Broad strength across our product portfolio
– Neulasta®/NEUPOGEN® grew 9%; Enbrel® grew 7%
– XGEVA® and Prolia® contributed over $240M
– Our growth-phase products grew 22%
• ESA business now represents a much smaller proportion
of our overall sales
• Pipeline continues to advance (with recent compelling data
from AMG 145† and AMG 827††; initiation of our phase 3
program for AMG 785 in PMO)
• Partnership and acquisition activity have enhanced
our pipeline and adds to our business internationally
*Adjusted, non-GAAP financial measure—if this slide is in hard copy, see reconciliations accompanying the presentation, or if this
slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section.
†Phase 1b; ††Phase 2
ESA = erythropoiesis-stimulating agent; PMO = postmenopausal osteoporosis
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 3
4. We See Growth Potential in Our
Neulasta®/NEUPOGEN® Franchise
• Potential growth in Neulasta®/NEUPOGEN® franchise
through our focus on first and every cycle use
– Unit growth in both US and EU for Neulasta®
in Q1, which is now ~80% of the franchise
• 40% of patients not receiving G-CSF with first
and every cycle of chemotherapy
• Continued Neulasta® growth in Europe despite
the availability of G-CSF biosimilars
G-CSF = granulocyte colony-stimulating factor
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 4
5. We Are Looking at Ways to Further
Grow Enbrel®
• With strong performance and extended exclusivity
we are investing in ENBREL for the short and
long term
– Positive response to recent DTC TV campaign
– Increasing share in patients new to biologics
• We don’t expect to see ENBREL biosimilar
competition for the foreseeable future
• We continue to develop strategies to ensure
patient access
DTC = direct to consumer
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 5
6. Our ESA Business Now Represents a
Much Smaller Proportion of Overall Sales
• Q1 ESA sales represented 25% of total sales vs
~50% 5 years ago
• Declines in our ESA business were more than offset
by revenue gains of our denosumab franchise
• We expect to compete effectively with peginesatide
and believe EPOGEN®’s attributes are well
appreciated for the dialysis setting
• We believe any significant further dose declines
will result in an increase in transfusions
• We continue to expect stabilization in the Aranesp®
business by mid-year
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 6
7. XGEVA®/Prolia® Have Significant
Growth Potential
• XGEVA® is taking unit share and growing the overall
SRE segment
• We will continue to launch XGEVA® in key European
markets throughout the year
• We are expanding the prescriber base for Prolia®
• Initial indicators on our DTC TV campaign
with Blythe Danner are positive
SRE = skeletal-related event
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 7
8. Our Pipeline Continues to Advance
AMG 145
• Phase 2 studies as monotherapy, in combination with statin therapy,
in heterozygous familial hypercholesterolemia, and in statin intolerant
subjects are completely enrolled—data expected this year
AMG 785*
• Phase 3 study in PMO initiated
• Phase 2 fracture healing data expected this year
Sensipar®/Mimpara®
• Phase 3 EVOLVE data expected mid-year
Talimogene Laherparepvec (T-VEC)
• Interim phase 3 melanoma data (durable response) expected in Q4
for internal review
• Overall survival data expected 2013
Brodalumab (AMG 827)
• Phase 3 psoriasis study initiation this year
*AMG 785 is being developed in collaboration with UCB
EVOLVE = Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 8
9. We Have Taken Decisive Actions to Optimize
Our Pipeline and Expand Internationally
• AstraZeneca partnership enables us to fund a
greater number of opportunities in our pipeline
• Planned acquisition of KAI brings an experimental
intravenous therapy for CKD patients with SHPT
that is administered coincident with dialysis
• Integration of Micromet is proceeding smoothly
and we are focused on advancing blinatumomab
programs in R/R ALL and NHL
• Recently announced planned acquisition of
Mustafa Nevzat provides a platform for future
growth in Turkey and the surrounding region
CKD = chronic kidney disease
SHPT = secondary hyperparathyroidism
R/R ALL = relapsed/refractory acute lymphoblastic leukemia
NHL = non-Hodgkin lymphoma
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 9
10. We Are Executing on Our Capital
Allocation Plan
• We purchased 21 million shares in Q1 at an average
price of $67.92 per share
– At the end of Q1, we had $3.6B in authorization
remaining and will continue to repurchase our shares
in the open market
• We will continue to increase our dividend
meaningfully over time
• We seek to improve our return on equity over time
• We will also continue to grow cash flows
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 10
11. Beyond 2012 We See Significant Growth
Opportunities
• Growing contribution of recently launched products
• Increased confidence in long-term outlook for
Enbrel® and margin expansion driven by change
in profit share with Pfizer
• Products emerging from R&D pipeline
• Growing international presence and entry
into biosimilars
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 11
13. Amgen Inc.
Condensed Consolidated Statements of Income and
Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
Three months ended Three months ended
March 31, 2012 March 31, 2011
GAAP Adjustments "Adjusted" GAAP Adjustments "Adjusted"
Revenues:
Product sales................................................................ $ 3,901 $ - $ 3,901 $ 3,618 $ - $ 3,618
Other revenues............................................................. 147 - 147 88 - 88
Total revenues...................................................... 4,048 - 4,048 3,706 - 3,706
Operating expenses:
Cost of sales (excludes amortization of certain
acquired intangible assets presented below)....... 679 (13) (a) 666 564 (24) (a) 540
Research and development.......................................... 736 (13) (b) 723 736 (33) (b) 703
Selling, general and administrative............................... 1,076 (19) (c) 1,057 1,023 (12) (c) 1,011
Amortization of certain acquired intangible assets....... 74 (74) (d) - 74 (74) (d) -
Other……...................................................................... 6 (6) (e) - 16 (16) (e) -
Total operating expenses..................................... 2,571 (125) 2,446 2,413 (159) 2,254
Operating income................................................................ 1,477 125 1,602 1,293 159 1,452
Interest expense, net........................................................... 235 (34) (f) 201 135 (44) (f) 91
Interest and other income, net............................................ 124 - 124 148 - 148
Income before income taxes............................................... 1,366 159 1,525 1,306 203 1,509
Provision for income taxes.................................................. 182 56 (g) 238 181 70 (g) 251
Net income.......................................................................... $ 1,184 $ 103 $ 1,287 $ 1,125 $ 133 $ 1,258
Earnings per share:
Basic............................................................................. $ 1.50 $ 1.63 $ 1.21 $ 1.35
Diluted (h)...................................................................... $ 1.48 $ 1.61 $ 1.20 $ 1.34
Average shares used in calculation
of earnings per share:
Basic............................................................................. 791 791 933 933
Diluted (h)...................................................................... 800 799 941 940
(a) - (h) See explanatory notes on the following pages.
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 13
14. Amgen Inc.
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
Three months ended
March 31,
2012 2011
(a) Adjustments to cost of sales:
Incremental expense resulting from accelerating depreciation and/or accruing losses for facility operating $ (10) $ (21)
leases as a result of our transaction with Boehringer Ingelheim involving our Fremont, California
manufacturing facility (the BI transaction)
Stock option expense (i) (3) (3)
Total adjustments to cost of sales $ (13) $ (24)
(b) Adjustments to research and development expenses:
Acquisition-related expenses $ (7) $ (7)
Non-cash amortization of R&D technology intangible assets acquired in business combinations
in prior years - (17)
Stock option expense (i) (6) (9)
Total adjustments to research and development expenses $ (13) $ (33)
(c) Adjustments to selling, general and administrative expenses:
Acquisition-related expenses $ (12) $ (2)
Stock option expense (i) (7) (10)
Total adjustments to selling, general and administrative expenses $ (19) $ (12)
(d) Adjustments to amortization of certain acquired intangible assets:
Non-cash amortization of product technology rights acquired in a prior year business combination $ (74) $ (74)
(e) Adjustments to other operating expenses:
Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations $ (1) $ (16)
Expense resulting from changes in the estimated fair values of the contingent consideration
obligations related to a prior year business combination (2) -
Expense related to certain legal proceedings (3) -
Total adjustments to other operating expenses $ (6) $ (16)
(f) Adjustments to interest expense, net:
Non-cash interest expense associated with our convertible notes $ (34) $ (44)
(g) Adjustments to provision for income taxes:
Income tax effect of the above adjustments (j) $ 56 $ 65
Income tax benefit related to certain prior period charges excluded from "Adjusted" earnings - 5
Total adjustments to provision for income taxes $ 56 $ 70
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 14
15. Amgen Inc.
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
(h) The following table presents the computations for GAAP and "Adjusted" diluted EPS, computed under the treasury stock method.
"Adjusted" EPS presented below excludes stock option expense:
Three months ended Three months ended
March 31, 2012 March 31, 2011
GAAP "Adjusted" GAAP "Adjusted"
Income (Numerator):
Net income for basic and diluted EPS………………………………………………………..…………………………$ 1,184 $ 1,287 $ 1,125 $ 1,258
Shares (Denominator):
Weighted-average shares for basic EPS………………………………………………….…………………………… 791 791 933 933
Effect of dilutive securities……………………………………………………………………...………………………… 9 8 (*) 8 7 (*)
Weighted-average shares for diluted EPS……………………………………………...……………………………… 800 799 941 940
Diluted EPS $ 1.48 $ 1.61 $ 1.20 $ 1.34
(*) Dilutive securities used to compute "Adjusted" diluted EPS for the three months ended March 31, 2012 and 2011 were computed under the treasury stock method
assuming that we do not expense stock options.
(i) For the three months ended March 31, 2012 and 2011, the total pre-tax expense for employee stock options was $16 million and $22 million, respectively.
"Adjusted" diluted EPS including the impact of stock option expense for the three months ended March 31, 2012 and 2011 was as follows:
Three months ended
March 31,
2012 2011
"Adjusted" diluted EPS, excluding stock option expense………………………………….……………………………$ 1.61 $ 1.34
Impact of stock option expense (net of tax)……………………………………………………...…………………… (0.02) (0.02)
"Adjusted" diluted EPS, including stock option expense………………………………...…………………………… $ 1.59 $ 1.32
(j) The tax effect of the adjustments between our GAAP and “Adjusted” results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the
applicable tax jurisdiction(s). Generally, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including amortization of intangible assets and non-cash
interest expense associated with our convertible notes, whereas the tax impact of other adjustments, including stock option expense, depends on whether the amounts are
deductible in the tax jurisdictions where the expenses are incurred or the asset is located and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax
rates for the adjustments to our GAAP results noted in notes (a) - (f) above, for the three months ended March 31, 2012 and 2011 were 35.2% and 32.0%, respectively.
Provided May 8, 2012 as part of an oral presentation and is qualified by such,
contains forward-looking statements, actual results may vary materially;
Amgen disclaims any duty to update. 15