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MORGAN
HEALTHCARE CONFERENCE
ROBERT A. BRADWAY
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
JANUARY 9, 2017
YoY
$17.0
6%
8.4
0%
8.6
12%
53%
4 pts
$8.74
12%
Item
Revenue
Non-GAAP EPS
*Through September 30, 2016; All income statement items for 2016, except revenue, are non-GAAP financial measuresif 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
Provided January 9, 2017, 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.
12%
38%
8%
YTD
19%
7%
19%
22%
8%
2012
14%
$6.5 7%
2013
12%
YTD
YTD
$17.3
53%
+15 points
2014
Revenues
2015
2016*
2012
17%
2013
2014
2015
2016*
2012
2013
2014
2015
2016*
Non-GAAP EPS
*2016 growth rates based on the nine months ended September 30, 2016, versus the nine months ended September 30, 2015; Non-GAAP financial measureif 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
Provided January 9, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
7
materially; Amgen disclaims any duty to update.
53%
52%54%
50%
40%
38%
Peers
30%
20%
10%
0%
2016
2013
2018 Commitment
10
11
CARDIOVASCULAR
Cardiovascular disease remains the worlds leading cause of death with societal
costs of over $600B annually
With mortality rates increasing for the first time in decades, Amgen is
committed to developing innovative medicines in this area
Atherosclerosis
Heart Failure
Repatha*
AMG 899 (CETP inhibitor)
Corlanor*
Omecamtiv mecarbil
Phase 2
ASGR1 inhibitor
AMG 986
Preclinical
Phase 1
Lp(a) inhibitor
Preclinical
CETP = cholesteryl ester transfer protein; CV = cardiovascular
*Mortality benefit not approved in current U.S. labeling; Developed in collaboration with Cytokinetics within an alliance with Servier
Provided January 9, 2017, 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
4,000
3,000
appropriate patients
NBRx share
of 55%
in Q4 2016
14
ONCOLOGY/HEMATOLOGY
XGEVA
Regulatory submission for prevention of SREs in multiple myeloma in 2017
New formulation of oprozomib entering clinic in 2017
SRE = skeletal-related event
Provided January 9, 2017, 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.
16
Additional BiTEs in the clinic for AML (CD33) and multiple myeloma (BCMA)
17
NEUROSCIENCE
Migraine
CGRP = calcitonin gene-related peptide; BLA = biologics license application; PAC1 = pituitary adenylate cyclase-activating polypeptide type I receptor
BACE = beta-site amyloid precursor protein-cleaving enzyme-1
Provided January 9, 2017, 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.
19
BONE HEALTH
since launch
35%+
CAGR
$1.3
$1.0
$0.7
$0.5
2012
2013
2014
2015
(romosozumab)
2016
EVENITY trade name provisionally approved by FDA, developed in collaboration with UCB globally, as well as Astellas in Japan
Provided January 9, 2017, 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.
21
expected Q2 2017
ARCH will contribute to EU submission
22
LIFECYCLE MANAGEMENT
24
BIOSIMILARS
FDA approved
HUMIRA ~ $16B
ABP 980
Herceptin ~ $7B
ABP 215
Avastin ~ $7B
ABP 710
Phase 3
REMICADE ~ $8B
ABP 798
Phase 3
RITUXAN ~ $8B
ABP 959
Phase 1
Soliris ~ $3B
ABP 494
Process development
ERBITUX ~ $2B
Molecules #8#10
Process development
~ $11B
AMJEVITA
Total
~ $60B+
*Per EvaluatePharma (December 8, 2016); numbers may not add due to rounding
Provided January 9, 2017, 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.
26
CAPITAL ALLOCATION
OUT-LICENSE
AMG 282/Asthma
28
$2.44 30%
$1.88 30%
$1.12
$1.44 31%
29%
$0.56
2011
2012
2013
2014
2015
2016
LTM = last twelve months; *FCF yield based on market capitalization as of January 3, 2017; Represents annualized dividend after September 2011 initiation;
2017 annualized dividend based on Q1 dividend payable March 8, 2016, future dividends subject to discretion of the Companys Board of Directors
Provided January 9, 2017, 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.
29
2017
31
Parsabiv
EVENITY (romosozumab)*
ABP 215 (biosimilar Avastin)
Submissions
Erenumab
XGEVA multiple myeloma
ABP 980 (biosimilar Herceptin)
BLINCYTO Ph+ R/R ALL
Pivotal Data
Repatha FOURIER
EVENITY ARCH*
Other
Parsabiv and EVENITY trade names provisionally approved by FDA; *Developed in collaboration with UCB globally, as well as Astellas in Japan; Developed in
collaboration with Cytokinetics within an alliance with Servier; mCRC = metastatic colorectal cancer; Ph+ = Philadelphia chromosome-positive
Provided January 9, 2017, 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.
32
2018 Commitments
Status
Double-digit growth,
on average
~ 52%54%
> $1.5B
~ 60%, on average
All items are non-GAAP financial measuresif this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically,
see reconciliations available at: www.amgen.com within the Investors section; *20142018 average
Provided January 9, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
33
long-term growth
Significant cash returns to shareholders
We are well on our way to achieving our commitments
for 2018
Provided January 9, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
34
RECONCILIATIONS
Amgen Inc.
Reconciliations of GAAP to Non-GAAP Measures
($ In millions)
(Unaudited)
Nine months ended September 30,
2016
2015
GAAP operating expenses
Adjustments to operating expenses:
Adjustments to cost of sales
Adjustments to research and development expenses
Adjustments to selling, general and administrative expenses
Certain net charges pursuant to our restructuring initiative (a)
Expense related to various legal proceedings
Acquisition-related adjustments (b)
Total adjustments to operating expenses
Non-GAAP operating expenses
9,717
9,689
(935)
(63)
(159)
(15)
(105)
(1)
(1,278)
8,439
(887)
(117)
(119)
(41)
(73)
(12)
(1,249)
8,440
7,309
6,437
8,470
6,191
1,147
26
105
1,278
8,587
1,010
166
73
1,249
7,686
1,377
114
91
1,582
10,052
1,546
596
(3)
129
16
2,284
8,475
16,229
15,615
20,944
2015
45.0%
7.9%
52.9%
$
5,787
1,278
(412)
(28)
6,625
$
$
758
7.63
8.74
41.2%
8.0%
49.2%
$
5,139
1,249
(404)
(15)
5,969
$
$
767
6.70
7.78
40.4%
7.6%
48.0%
$
6,939
1,582
(496)
(71)
7,954
$
$
766
9.06
10.38
19,327
5,867
5,577
986
71
14
34
1,105
6,972
470
347
64
59
940
6,517
18,192
16,639
32.0%
11.8%
43.9%
$
5,158
2,284
(717)
(25)
6,700
$
$
770
6.70
8.70
2012
32.3%
6.1%
38.3%
33.5%
5.6%
39.2%
5,081
4,345
1,105
12
22
(376)
(30)
5,814
940
140
(329)
23
5,119
$
$
765
6.64
7.60
$
$
787
5.52
6.51
The adjustments related primarily to asset impairments, accelerated depreciation and other charges related to the closure of our facilities, as well as severance. 2015 also included gains recognized on the sale of assets related to our site closures.
(b) The adjustments related primarily to non-cash amortization of intangible assets acquired in business combinations. For the nine months ended September 30, 2016, the adjustments also included a $73-million charge resulting from the
reacquisition of Prolia, XGEVA and Vectibix license agreements in certain markets from Glaxo Group Limited.
(c)
The adjustments related to the recognition of an additional year of the non-tax deductible branded prescription drug fee, as required by final regulations issued by the Internal Revenue Service.
(d) The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, this results in a tax impact at the
U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets, whereas the tax impact of other adjustments, including restructuring expense, depends on whether the amounts are deductible in the
respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions.
(e)
The adjustments related to certain prior period items excluded from non-GAAP earnings, resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities, and a change in interpretation of tax law, as applicable. The
2016 adjustments related primarily to the impact from the adoption of Accounting Standards Update 2016-09, Improvements to Employee Share-Based Payment Accounting , related to stock options that were previously excluded from non-GAAP
measures.
36
Amgen Inc.
Reconciliations of Free Cash Flow
($ In millions)
(Unaudited)
Nine months ended
September 30, 2016
Operating Cash Flow
Capital Expenditures
Free Cash Flow
7,254
(511)
6,743
37
2,060
(205)
1,855
Amgen Inc.
Reconciliation of Future GAAP to Non-GAAP Financial Measures
Management has presented herein certain forward-looking statements about the Companys future financial performance that include non-GAAP net income
for various years through December 31, 2018. This nonGAAP financial measure is derived by excluding certain amounts, expenses or income, from the
corresponding financial measures determined in accordance with GAAP. The determination of the amounts that are excluded from this non-GAAP financial
measure is a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts recognized
in a given period. We are unable to present a quantitative reconciliation of the aforementioned forward-looking non-GAAP financial measure to its most
directly comparable forward-looking GAAP financial measure because management cannot reliably predict all of the necessary components of such GAAP
measure. Historically, management has excluded the following items from this non-GAAP financial measure, and such items may also be excluded in future
periods and could be significant:
Expenses related to the acquisition of businesses, including amortization and / or impairment of acquired intangible assets, including in-process
research and development, adjustments to contingent consideration, integration costs, severance and retention costs and transaction costs;
Charges associated with restructuring or cost saving initiatives, including but not limited to asset impairments, accelerated depreciation,
severance costs and lease abandonment charges;
Legal settlements or awards;
The tax effect of the above items; and
Non-routine settlements with tax authorities.
38
ROBERT A. BRADWAY
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
JANUARY 9, 2017