corresp
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Amgen Inc. |
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One Amgen Center Drive |
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Thousand Oaks, CA 91320-1799 |
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Phone: 805.447.1000 |
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May 13, 2011
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VIA EDGAR
Ms. Sasha S. Parikh
Staff Accountant
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
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Re: |
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Amgen Inc.
Form 10-K for the Year Ended December 31, 2010
Definitive Proxy filed April 7, 2011
File No. 0-12477 |
Dear Ms. Parikh:
We are responding to the Staffs comment letter dated April 15, 2011 regarding the review of
the above-referenced filings of Amgen Inc. (we, Amgen or the Company). We have set forth
below our responses to the inquiries raised in the letter. For ease of reference, we have included
the Staffs comments in their entirety in bold and italicized text preceding each of our responses.
Form 10-K for the Year Ended December 31, 2010
Research and Development and Selected Product Candidates, page 33
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1. |
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In order to help us evaluate your disclosure about your research and
development activities, please provide us the following information: |
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A description of your research and development process. In your response,
please describe the key management activities you undertake in your
modality-independent approach to research and development, including a description
of your process for identifying targets and choosing the best modality to address
the target. Please explain how you monitor development progress for individual
projects (e.g. board reviews), your criteria for prioritizing and funding projects,
your key decision points for determining |
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 2 of 17
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project continuance or termination and the financial measures used to evaluate
performance of your research and development function. Clarify whether you manage
projects individually or whether you concentrate management based on groupings of
projects, such as those in later stages of development versus earlier stages of
development versus discovery. |
The Company supplementally advises the Staff as follows:
Guiding Principles
Our vision is to deliver therapeutics that can make a meaningful difference in patients lives. To
help achieve this, Amgen applies four guiding principles to its research and development (R&D)
process.
The first is to focus our efforts on developing therapies that have a beneficial effect on patients
suffering from the greatest unmet medical needs. These areas of need currently include oncology,
hematology, inflammation, bone, nephrology, cardiovascular and general medicine, which includes
neurology. Beginning with an unmet medical need, our scientists study the course of a disease to
identify targets where a potential drug may have a beneficial effect.
The Companys second guiding principle is to take a modality-independent approach to R&Dthat is,
once we identify targets, we then choose the modality we believe is best suited to address a
specific target. As such, the Companys discovery research programs may yield targets that lead to
the development of human therapeutics delivered as large molecules (such as proteins, antibodies
and peptibodies) or small molecules. Large and small molecules each have unique and inherent
advantages and disadvantages. Although multiple factors can be involved in the selection of a
modality, key criteria include the molecular nature of the target, anatomical location/distribution
of the target, whether the target is intracellular or extracellular in nature and whether we want
to block or activate the intrinsic activity of the target. Our modality-independent approach
provides the Company with the flexibility to leverage the advantageous aspects of a particular
approach that we believe are best suited to interdict a disease, without being tied to one
particular modality.
The Companys third major emphasis is to study disease in patients. All too often, our industry
has found that experimental models have little predictive value with respect to human disease,
which often results in the failure of clinical trials and escalation of drug development costs.
While it is significantly more complicated to study disease in humans, we believe that this is the
only way to successfully develop human therapeutics. Defining the key elements of disease in
patient populations drives our R&D investment and the potential
therapeutics we pursue.
The Companys fourth guiding principle is seamless integration. We strive to integrate our
organization by incorporating the perspectives from sales and marketing, clinical development and
basic research into all of our drug development programs. There are important insights that come
to basic research and clinical development from understanding the medical marketplace,
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Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 3 of 17
and vice versa. Aligning our priorities across these functions helps ensure that we develop
potential therapeutics in a manner that we expect to address unmet medical needs and meet the
changing demands of the marketplace.
Monitoring the Development Process
To bring vital medicines to patients, we rigorously test product candidates. Our process to
develop potential therapeutics is organized into stages, each involving a unique set of
requirements, tests and studies that must be completed in order for the potential therapeutic to
progress to the next stage of development.
The process begins with our scientists studying the course of a disease. This enables them to
identify points in the disease where a treatment may have an effect. Multiple Amgen teams
simultaneously study many different diseases in need of treatment. When we find one or more points
in a disease to target, then our scientists test thousands of molecules for activity against that
target. Usually only a small number are active and have the right characteristics to warrant
further study. We then decide which of these molecules is most promising and test whether it has
the characteristics necessary to help patients with a serious illness.
Once we have selected a molecule, our next goal is to be able to test it in humans to determine if
the molecule will be safe and effective when used in people. After thoroughly analyzing a
molecules safety to determine whether it is ready for testing in humans, we then seek approval
from regulatory agencies to begin clinical trials.
In small Phase 1 clinical studies conducted either in healthy volunteers or in people with the
targeted disease we gather preliminary data regarding the safety and efficacy of the product
candidate and establish a range of doses for further testing.
In Phase 2 clinical studies, we attempt to test the product candidate in enough patients suffering
from the targeted disease to assess the product candidates effectiveness and we continue to
evaluate its safety. Phase 2 studies can also help determine dosing and a treatment schedule.
Phase 3 trials are designed to confirm the safety and effectiveness of a product candidate in large
numbers of patients with the targeted disease. If the outcome is successful, we generally submit
the product candidate to regulatory agencies for their approval. Once approved, we monitor safety
for as long as the product is prescribed to patients. From time to time, we may seek regulatory
approval to update manufacturing methods or to conduct new clinical trials to add new indications
to treat other unmet medical needs.
Over the course of this development process, there are several review points, or portals, where
the product candidate is evaluated to determine if it should advance to the next stage of
development. Portal examples include identifying a molecule as a viable clinical candidate,
progressing the product candidate into preclinical testing, deciding to begin testing in humans
3
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 4 of 17
(Phase 1) and initiating Phase 2 and Phase 3 studies. These portals are governed by
executive-level cross functional review boards that evaluate scientific, medical, manufacturing,
commercial and financial information to assess the value of the product candidate to patients and
Amgen. These review boards, which are explained in greater detail below, determine whether to
advance a product candidate to the next stage, collect more data, out-license the molecule or
terminate the program. A number of factors are considered by the review boards in making these
decisions. The deciding factor or factors leading to each decision to advance, collect more data
for, out-license or terminate a program can vary by stage and on the particular facts and
circumstances around each program. Factors considered in such decisions include, but are not
limited to, safety profile of the product candidate, efficacy of the product candidate towards the
identified target, competitive landscape in the target therapeutic area, capabilities of the
Company to successfully develop the product candidate, partnership commitments or requirements and
the potential opportunity relative to other programs in our pipeline.
The composition of the portal governance boards changes as molecules progress from early to late
stages of development, but all relevant functional and regional perspectives are always
represented.
Research programs are managed individually by cross-functional teams (Product Strategy Teams, or
PSTs) who also receive management oversight from more senior leaders (Therapeutic Area Steering
Committees, or TASCs). The TASCs are responsible for managing a cluster of products based on
their therapeutic area of expertise. Both PSTs and TASCs are accountable to distinct governance
review boards. Earlier stage programs, or programs in early discovery through Phase 1, are
governed by the Early Review Board (ERB). Late stage programs, or programs in Phase 2 or later,
and marketed products are governed by the Late Stage Review Board (XRB). Investments at the
Phase 2 trial and later stages of development are the most significant and therefore the XRB
includes senior executive leadership representation from several functions, including R&D,
Manufacturing, Commercial and Finance. Additionally, the ERB and XRB make portfolio management
decisions for early stage programs and late stage and marketed product programs, respectively.
Finally, we provide programmatic updates to our Board of Directors on a periodic basis to keep them
informed of development progress.
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Quantify the number of projects that were in preclinical development and
Phase 1, Phase 2 and Phase 3 of clinical development and those for which a
submission requesting regulatory approval was filed as of December 31, 2010. |
The Company supplementally advises the Staff as follows:
4
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 5 of 17
The table below quantifies the number of projects that, as of February 9, 2011,1 were in
Phase 3, Phase 2 and Phase 1.
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# of programs |
Phase 3
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9 |
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Phase 2
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14 |
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Phase 1
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21 |
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These figures correspond to the projects listed under Phase 3 Programs, Phase 2 Programs and Phase
1 Programs in the table on page 35 of the Form 10-K for the fiscal year ended December 31, 2010
(the 2010 Form 10-K). We respectfully direct the attention of the Staff to the language in the
paragraph preceding the table on page 35 of the 2010 Form 10-K, in which we explain that each
target indication for product candidates in phase 3 is listed separately. Molecules in earlier
phases of development are listed by their most advanced phase of development (e.g., a cancer
therapy being studied in both Phase 2 and Phase 1 clinical trials for
different tumor types would be listed in Phase 2).
The Company respectfully submits that information regarding the quantity of our preclinical
research programs is not material to investors. Preclinical research is by its nature highly
experimental and, as would be expected of such activities, has relatively high failure rates. We
may test thousands of molecules (hundreds of which may not even go beyond in vitro testing) to
address a single disease target, and as a consequence of this high rate of throughput, our
preclinical program portfolio may change significantly during the course of a year. Further, even
successful preclinical research must then be continued in many years of human clinical trials as
the investigational product advances through Phases 1, 2 and 3, with many molecules failing at some
stage of the process. Given that the vast majority of molecules examined in preclinical research
never become commercialized human therapeutics, we historically have not described our preclinical
research portfolio in our periodic reports. Furthermore, we respectfully submit that knowing this
number over time would not provide investors with a helpful measurement of the Companys
preclinical research given the wide variations in scope, type and nature of the preclinical
programs themselves. For example, during the course of a year the Company could terminate a large
number of very early stage in vitro preclinical programs while simultaneously moving forward with a
small number of larger in vivo preclinical research programs. Over this period, while the absolute
number of preclinical programs would have declined, the remaining programs may be at a more
advanced stage of preclinical development (albeit a stage with the relatively high
failure rates discussed above). Consequently, we have not included
in our periodic report disclosure any quantification of our preclinical program portfolio, and do
not propose to add such information in the future.
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1 |
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February 9, 2011 is the date of the pipeline
information provided in the chart on page 35 of our Form 10-K for the year
ended December 31, 2010. |
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Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 6 of 17
The following table provides the pending regulatory submissions which were filed in major markets
(i.e., United States and the European Union) as of February 9, 2011:
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Program |
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US Filing Date |
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EU Filing Date |
XGEVA SRE (skeletal related events)
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5/2010 (approval 11/2010)
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6/2010 |
Vectibix®
1st/2nd line
mCRC (metastatic colorectal cancer)
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11/2010 (1st line) & 10/2010 (2nd Line)
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4/2010 |
From time to time the Company requests marketing authorization approval by the applicable
regulatory authorities in new territories or countries where our products were not previously
marketed. The Company does not disclose filings in these non-major markets in our periodic reports
because we do not deem them material.
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A breakout of research and development expenses incurred during 2010, if
practicable by development phase (i.e., preclinical, Phases 1, 2 and 3) and by
therapeutic class. |
The Company supplementally advises the Staff that we manage R&D expenses on a functional basis that
crosses all phases of development and therapeutic classes. More specifically, the Company manages
R&D expenses across its major functions, including Discovery Research, Translational Sciences,
Development, Regulatory and Safety, and R&D Administration on a portfolio basis, each of which can
cross multiple therapeutic areas and phases of development. This functional approach in R&D is
consistent with our expense management approach across the Company.
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For each project in the table on page 35, provide the month and the year
that it entered that phase. |
The Company supplementally provides the Staff with the information set forth on Appendix 1. The
Company respectfully advises the Staff that it does not believe that information regarding when
individual programs enter various phases of development is material to investors prior to the
programs entering Phase 3. As each program is different and clinical trials being conducted vary
significantly by study design, specified endpoint(s) and expected duration, the time when a
particular phase of development begins does not necessarily correlate to when an investor can
reasonably expect to see clinical trial results. Further, because of the highly experimental
nature of clinical trials and resulting high failure rates, timing information about these earlier
stage programs also fails to provide investors with material information about when a particular
clinical program will result in a meaningful commercial benefit to the Company. Consequently, the
Companys Phase 1 and Phase 2 product candidates are listed in the Companys Annual Report on Form
10-K on an annual basis, with generally no reference to the start date of the
respective programs. As product candidates move into Phase 3, however, the Company provides more
detail in its periodic reports regarding the development of these products, as the probability
6
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 7 of 17
of successful commercialization and the level of spending have increased significantly beyond prior
phases of development. The Companys practice is to include in each quarters periodic report the
material changes in our pipeline which in our view include the entry of a program into Phase 3
of development, the termination of a program after entering Phase 3 and the filing for marketing
approval of a product candidate with the applicable regulatory agencies in major markets that
have occurred during that quarterly period.
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For each project in the table on page 35, identify the significant patents
associated with the project and their expiration date. |
The Company respectfully directs the attention of the Staff to pages 7 through 17 of the 2010 Form
10-K, where we have listed the material patents for each of the Companys currently marketed
products. The Company respectfully submits that patent information for its investigational
products that have not yet been approved or commercialized is generally not material to the
Companys stockholders. However, if and when a particular late-stage program becomes material to
our stockholders, we include in our periodic reports additional information about that program,
including information about the significant patents related to that program. For example, we
respectfully direct the attention of the Staff to page 16 of our Annual Report on Form 10-K for the
year ended December 31, 2009 (the 2009 Form 10-K), where we list the outstanding material patents
for denosumab, which at that time had become material to stockholders as of the period covered by
the filing despite not yet having been approved for commercial sale or use by the FDA or any other
regulatory agency.
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For each project in the table on page 35, tell us the projects added to and
deleted from the table since 2009. For those removed from this table clarify
whether they were commercialized or terminated. For each terminated project,
if any, tell us the events and their timing leading to your decision to
terminate the project. |
The Company supplementally advises the Staff as follows:
The intent of the Companys pipeline disclosure is to present the current state of our pipeline as
a whole at the time of the Annual Report on Form 10-K. In addition, as explained above, material
changes in our pipeline during the year (the entry of a program into Phase 3 of development, the
termination of a program after entering Phase 3 and the filing for marketing approval of the
product candidate with the applicable regulatory agencies in major markets) are disclosed in our
periodic reports for the quarters in which such changes occur. When compared to the pipeline table
contained in the Companys 2009 Form 10-K, the pipeline table contained in the 2010 Form 10-K
reflects that we (i) added five new Phase 1 programs and one new Phase 2 program, (ii) filed for
regulatory approval for three Phase 3 programs and (iii) terminated three Phase 2 programs and one
Phase 3 program.
The Company reported in its Form 10-Q for the period ended September 30, 2010 the termination of
the Phase 3 program (Vectibix® in combination with platinum-based
7
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 8 of 17
chemotherapy
in recurrent and/or metastatic head and neck cancer) as a result of its failure to
meet its primary endpoint, which was statistically significant improvement in overall survival. We
supplementally advise the Staff that the Company terminated the three Phase 2 programs due to
failure to achieve a competitive commercial profile. However, given the earlier phase of
development of these programs, separate disclosure of their termination was not considered material
to investors.
The following table illustrates the changes across our portfolio from the 2009 Form 10-K to the
2010 Form 10-K:
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Summary |
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Total |
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Description |
New Phase 1 Programs
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5 |
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AMG 139, AMG 181, AMG 319, AMG 337, AMG 780 |
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New Phase 2 Programs
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1 |
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Sensipar®/Mimpara® Post Renal Transplant |
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Filed / Approved
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3 |
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Denosumab-Bone Loss induced by hormone ablation,
Denosumab-Cancer related bone damage (SRE),
Denosumab- Postmenopausal osteoporosis |
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Terminated Programs
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4 |
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AMG 108 (Phase 2), AMG 222 (Phase 2), AMG 223 (Phase 2),
Vectibix® Recurrent and/or metastatic head and
neck cancer (Phase 3) |
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Tell us about the projects that are not listed in the table on page 35 and
the reason not listed. |
The Company supplementally advises the Staff that every project conducted in humans was listed in
the table on page 35 of the 2010 Form 10-K. The Company excluded preclinical programs from the
table for the reasons outlined above.
Managements Discussion and Analysis of Financial condition and Results of Operations
Financial Condition, Liquidity and Capital Resources, page 78
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2. |
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You disclose that of your $17.4 billion in cash, cash equivalents and
marketable securities at December 31, 2010, $15.1 billion was generated from operations
in foreign tax jurisdictions that is intended to be invested indefinitely outside the
U.S. You also disclose that in February 2011, you repaid $2.5 billion in Convertible
Notes. Please provide us proposed revised disclosure to be included in future periodic
reports that specifically discusses how you repaid the $2.5 billion in Convertible
Notes and how you have the wherewithal to continue to
meet your obligations in the U.S. when the vast majority of your cash, cash
equivalents and marketable securities are outside the U.S. |
8
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 9 of 17
The Company supplementally advises the Staff as follows:
Our worldwide operations generate significant annual operating cash flows. For the three years
ended December 31, 2010, our cash flows from operations aggregated $5.8 billion, $6.3 billion and
$6.0 billion, respectively. A substantial portion of these operating cash flows was generated by
and is available for use in our U.S. operations. In addition, as discussed in our response to
Comment 4 below, the Company is vertically integrated with operations in the United States and
various foreign jurisdictions. These operations benefit the Companys worldwide activities and
result in intercompany payments from and to our U.S. operations. The timing of these intercompany
payments varies and as such, influences our U.S. cash flows on an interim basis.
The Company proposes to enhance its Managements Discussion and Analysis of Financial Condition and
Results of Operations (MD&A) disclosures with respect to Financial Condition, Liquidity and
Capital Resources in its future periodic reports beginning with our Form 10-Q for the quarter
ending June 30, 2011. The Companys proposed disclosure to be included in the MD&A section of such
future periodic reports is as follows:
We believe existing funds, cash generated from operations and existing sources of
and access to financing are adequate to satisfy our working capital, capital
expenditure and debt service requirements, our plans to pay dividends and
opportunistically repurchase stock, as well as other business initiatives we plan to
strategically pursue, including acquisitions and licensing activities, for the
foreseeable future. We anticipate that our liquidity needs can be met through a
variety of sources, including cash provided by operating activities, sale of
marketable securities, borrowings through commercial paper and/or our syndicated
credit facility and access to other debt markets and equity markets. With respect
to our U.S. operations, we believe that existing funds intended for use in the U.S.
(U.S. funds), cash generated from our U.S. operations, including intercompany
payments and receipts, and existing sources of and access to financing in the U.S.
are adequate to continue to meet our U.S. obligations (as well as our plans to pay
dividends and opportunistically repurchase stock with U.S. funds) for the
foreseeable future. In February 2011, we repaid our 2011 Convertible Notes with an
aggregate principal balance of $2.5 billion with available U.S. funds. (See Item
1A. Risk Factors Current economic conditions may magnify certain risks that
affect our business.)
Notes to Consolidated Financial Statements
4. Income Taxes, page F-14
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3. |
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On page F-16 you disclose that your undistributed earnings from foreign
operations include income from manufacturing operations in Puerto Rico that are subject
to tax incentive grants that expire in 2020. Please provide us proposed revised
disclosure to be included in future periodic reports that |
9
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 10 of 17
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quantifies the benefit, in terms of dollars and earnings per share impact,
associated with these Puerto Rican tax incentive grants. Please see SAB 11:C. |
The Company respectfully directs the Staff to Note 4, page F-16 of our 2010 Form 10-K, which
provides a reconciliation of the federal statutory income tax rate to our effective tax rate (the
statutory to effective tax rate reconciliation table) and
discloses decreases from the statutory
tax rate due to Foreign earnings, including earnings invested indefinitely of 19.1%, 19.6% and
16.7% for each of the three years in the period ended December 31, 2010. Substantially all of this
reduction in our effective tax rate (or tax benefit) results from foreign income associated with
the Companys operations conducted in Puerto Rico that are subject to a tax incentive grant. The
Company respectfully suggests that the dollar effect of the tax benefit can be calculated by
multiplying each years percentage by pre-tax book income and the per share impact of the tax
benefit can be calculated by dividing the dollar effect by the number of shares used to compute
that years diluted earnings per share.
The Company proposes to enhance its disclosures with respect to the benefit of our Puerto Rico tax
incentive grant in our future periodic reports beginning with our Form 10-K for the year ending
December 31, 2011. The Companys proposed disclosure to be included in the Income Tax Note to our
Consolidated Financial Statements is as follows (using our 2010 Form 10-K disclosures as an
example):
The reconciliation between the federal statutory rate and our effective tax rate is
as follows:
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Years ended December 31, |
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2010 |
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2009 |
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2008 |
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Federal statutory rate applied to
income before income taxes |
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35.0 |
% |
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35.0 |
% |
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35.0 |
% |
Foreign earnings, including earnings
invested indefinitely |
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(19.1 |
)% |
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(19.6 |
)% |
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(16.7 |
)% |
State taxes |
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1.6 |
% |
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1.1 |
% |
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1.4 |
% |
Audit settlements |
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(3.1 |
)% |
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(4.2 |
)% |
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0.0 |
% |
Credits, primarily
research and experimentation |
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(0.9 |
)% |
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(0.8 |
)% |
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(1.1 |
)% |
Other, net |
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(0.5 |
)% |
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0.0 |
% |
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0.6 |
% |
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Effective tax rate |
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13.0 |
% |
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11.5 |
% |
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19.2 |
% |
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We do not provide for U.S. income taxes on undistributed earnings of our
foreign operations that are intended to be invested indefinitely outside of the
United States. Substantially all of the benefit from foreign earnings on our
effective tax rate results from foreign income associated with the Companys
operations conducted in Puerto Rico that is subject to a tax incentive grant that
expires in 2020.
10
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 11 of 17
For the years ended December 31, 2010, 2009 and 2008, our total foreign income
before income taxes was approximately $3.1 billion, $3.1 billion and $2.6 billion,
respectively. At December 31, 2010, cumulative foreign earnings amounted to
approximately $17.2 billion. If these earnings were repatriated to the U.S., we
would be required to accrue and pay approximately $6.1 billion of additional income
taxes based on the current tax rates in effect.
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4. |
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Your foreign operations accounted for 29%, 28%, and 27% of your revenues and
58%, 60% and 52% of your pre-tax income in 2010, 2009 and 2008, respectively. Please
provide us proposed MD&A disclosure to be included in future periodic reports
explaining the underlying reasons for the disproportionate pre-tax income of your
foreign operations in relation to your foreign sales. Please also discuss in this
proposed disclosure the reasons why your effective tax rate of 13.0% in 2010, 11.5% in
2009 and 19.2%, in 2008 is significantly lower than the statutory rate of 35%,
including the countries that account for the majority of the lower effective tax rate. |
The Company supplementally advises the Staff as follows:
Sales revenues are reported based on the location in which sales are made to third parties. The
Company currently generates the majority of its sales revenues in the United States. Pre-tax
income is reported based on the location of the operations giving rise to the pre-tax income.
Certain operations of the Company are performed in foreign jurisdictions. The worldwide pre-tax
income associated with such operations is treated as foreign income based on the tax laws and
principles of the respective taxing jurisdictions. For example, the Company conducts significant
operations outside the United States in Puerto Rico pertaining to manufacturing, distribution and
other related functions to meet its worldwide product demand. Income from the Companys operations
in Puerto Rico is subject to a tax incentive grant that expires in 2020. In addition, as we
disclose in the MD&A section on page 85 of the 2010 Form 10-K, our effective tax rate reflects the
impact of undistributed foreign earnings for which no U.S. taxes have been provided because such
earnings are intended to be invested indefinitely outside the United States.
The Company proposes to enhance its MD&A disclosures with respect to foreign earnings and the
effective tax rate in its future periodic reports beginning with our Form 10-K for the year ending
December 31, 2011. The Companys proposed disclosure to be included in the MD&A section of our
future Annual Reports on Form 10-K is as follows:
The Company is a vertically integrated enterprise with operations in the U.S. and
various foreign jurisdictions. The Company is subject to income tax in the foreign
jurisdictions where it conducts activities based on the tax laws and principles of
such jurisdictions and the functions, risks and activities performed
therein. The Companys pre-tax income is therefore attributed to domestic or
foreign sources based on the operations performed in each location and the tax
11
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 12 of 17
laws and principles of the respective taxing jurisdictions. For example, the
Company conducts significant operations outside the United States in Puerto Rico
pertaining to manufacturing, distribution and other related functions to meet its
worldwide product demand. Income from the Companys operations in Puerto Rico is
subject to a tax incentive grant that expires in 2020.
Our effective tax rate reflects the impact of undistributed foreign earnings for
which no U.S. taxes have been provided because such earnings are intended to be
invested indefinitely outside the United States. Substantially all of this benefit
is attributable to the Companys foreign income associated with the Companys
operations conducted in Puerto Rico.
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5. |
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Based on your tax provision disclosure on page F-14 and your disclosure of
foreign pre-tax income on page F-16, it appears that your effective foreign tax rate
was 5.0% in 2010 and 2009 and 5.5% in 2008. However, based on the impact of the
foreign tax rate differential presented in your tax rate reconciliation on page F-16,
it appears that your effective foreign tax rate should be approximately 2.2% in 2010,
2.1% in 2009 and 2.8% in 2008. Please explain to us how you computed the 19.1%, 19.6%
and 16.7% foreign rate differential reconciling item for 2010, 2009 and 2008,
respectively, and identify for us the significant components of these reconciling
items. Also, in your response please explain to us the apparent discrepancy between
the effective foreign tax rates identified in the first two sentences of this comment. |
The Company supplementally advises the Staff as follows:
The foreign rate differential reconciling items are calculated as the amount of tax that would be
paid if the foreign income was subject to the statutory rate of 35%, less the provision for foreign
taxes, net of foreign tax credits, divided by consolidated pre-tax income. Substantially all of
this benefit is attributable to the Companys foreign income associated with the Companys
operations conducted in Puerto Rico.
The difference between the effective tax rate calculated using the tax provision disclosure on page
F-14 of the Form 2010 10-K and the statutory to effective tax rate reconciliation table on page
F-16 of the 2010 Form 10-K relates to certain foreign taxes that do not impact our effective tax
rate due to the related offsetting U.S. foreign tax credits discussed above.
19. Contingencies and commitments
Contingencies, page F-38
|
6. |
|
Your note discloses several pending legal proceedings, yet you do not appear to
disclose your policy for the accounting for contingencies or the disclosures required
by ASC Section 450-20-50. Please provide us proposed policy note |
12
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 13 of 17
|
|
|
disclosure to be included in future periodic reports that indicates your policy for
accounting for loss and gain contingencies. In addition, in a risk factor on page
55 and in MD&A on page 85, you disclose that litigation and government
investigations could result in a material adverse impact on your results of
operations, financial condition or cash flows. As a result, it appears at least
reasonably possible that a loss may have been incurred. Therefore, please provide
us proposed revised disclosure to be included in future periodic reports that
discloses: |
|
|
|
The amounts accrued for loss contingencies accrued as required by ASC
450-20-50-1, and |
|
|
|
An estimate of the possible loss or range of loss or a statement that such
an estimate cannot be made for loss contingencies that are at least reasonably
possible but not accrued, either because it is not probable that a loss has
been incurred or the amount of loss cannot be reasonably estimated, as required
by ASC 450-20-50-3 and 50-4. If you cannot make an estimate, please disclose
the facts and circumstances that prevent you from making such an estimate as
well as a discussion of what is being sought in those proceedings. |
The Company respectfully directs the attention of the Staff to page F-38 of the 2010 Form
10-K, under Note 19, Contingencies and commitments, that contains the following disclosure
regarding the Companys policy for accounting for contingencies:
In the ordinary course of business, we are involved in various legal proceedings
and other matters, including those discussed in this Note, which are complex in
nature and have outcomes that are difficult to predict. We record accruals for
such contingencies to the extent that we conclude that it is probable that a
liability will be incurred and the amount of the related loss can be reasonably
estimated. While it is not possible to accurately predict or determine the
eventual outcome of these items, one or more of these items currently pending
could have a material adverse effect on our consolidated results of operations,
financial position or cash flows.
The Company respectfully submits that its disclosures are consistent with the guidance in ASC
450-20-50. Specifically, the Company records accruals for contingent liabilities when management
is able to conclude that a loss is both probable and reasonably estimable, as required under ASC
450-20-25-2. When a loss is both probable and estimable, the Company discloses the amount of
accrual for litigation loss contingencies when required by ASC 450-20-50-1, including when it
determines that specific disclosure of the amount accrued may be necessary in order to prevent the
financial statements from being misleading.
When a loss is not both probable and estimable, the Company assesses whether disclosure of a
loss contingency should be made (even where an appropriate accrual cannot be determined) based on
whether there is at least a reasonable possibility that a loss or an additional
13
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 14 of 17
loss may be incurred. In determining whether an estimate of possible loss or range of loss may
be determined, the Company reviews all of the facts and circumstances relating to each legal
proceeding. The Company thoroughly analyzes the procedural posture and substance of each claim,
the facts in dispute in a particular matter (including facts revealed in discovery, substantive
rulings by the court, advice of experts and counsel, information gleaned through settlement
discussions and other information), relevant statutes or case law and their likely applicability to
the matter, the Companys available legal defenses, its litigation strategies and opportunities for
settlement. This analysis is based on managements best judgment of each litigation matter and is
made upon advice of, and in consultation with, counsel.
The Company has concluded that, with respect to its litigation matters disclosed in Note 19
(which are incorporated by reference into the Legal Proceedings section of the 2010 Form 10-K), it
cannot reasonably estimate possible losses associated with those matters. To do so would, for
example, require broad speculation about possible conduct or decisions of litigation
counterparties, factfinders and tribunals, an assessment of novel claims or claims that are at
preliminary stages of adjudication, or an assessment of future actions or decisions that could be
viewed as unlikely or unusual. An assessment as to the possible losses that the Company might
incur would require the Company to make a judgment for which there would be generally no reasonable
basis.
As a result, the Company believes a range of possible loss is not estimable for asserted and
probable unasserted claims. In future filings, the Company will, consistent with ASC 450-20-50-4,
include a statement that such an estimate cannot be made.
The Company respectfully acknowledges its statement in a risk factor on page 55 and in the
MD&A section on page 85 of the 2010 Form 10-K that certain pending litigation and governmental
proceedings could have a material adverse effect on our consolidated results of operations,
financial position or cash flows. The Company does not intend for this disclosure to imply that it
is reasonably possible a litigation loss has in fact been incurred within the meaning of applicable
accounting literature. In fact, the Company is unable to give an estimate of possible losses or
range of losses and includes the discussion of these risks pursuant to the Companys disclosure
obligation under Item 503(c) of Regulation S-K, as required under Item 1A of Form 10-K. The
Company respectfully submits that, although the legal proceedings at issue do not represent a loss
that is both probable and reasonably estimable within the meaning of ASC 450-20-25-2, one or more
of such legal proceedings nonetheless could result in liability to the Company that could have a
material adverse effect on the Companys consolidated results of operations, financial position or
cash flows.
For the foregoing reasons, the Company respectfully submits that its disclosures are
consistent with the guidance in ASC 450-20-50.
14
Sasha S. Parikh
Securities and Exchange Commission
May 13, 2011
Page 15 of 17
Definitive Proxy filed April 7, 2011
|
7. |
|
We have not yet reviewed the Part III information that is included in your Form
10-K. We may have further comments after reviewing that information and we will not be
able to clear our review of your filing until we have the opportunity to resolve any
resulting comments. |
The Company acknowledges that the Staff may have additional comments following its review of
the Part III information contained in the Companys definitive proxy statement filed April 7, 2011.
* * * *
Pursuant to your request, the Company acknowledges that: (i) it is responsible for the
adequacy and accuracy of the disclosure in its filings; (ii) Staff comments or changes to
disclosure in response to Staff comments do not foreclose the Commission from taking any action
with respect to the filings; and (iii) the Company may not assert Staff comments as a defense in
any proceeding initiated by the Commission or any person under the federal securities laws of the
United States.
Please contact Charles K. Ruck of Latham & Watkins LLP at (714) 540-1235 or me at (805)
447-9358 should you have further comments or if you require any additional information.
|
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Respectfully yours,
|
|
|
/s/ Jonathan M. Peacock
|
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Jonathan M. Peacock |
|
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Executive Vice President and
Chief Financial Officer |
|
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cc: |
|
Mark Brunhofer, the Commission
Karen Ubell, the Commission
Jennifer Riegel, the Commission
David J. Scott, Esq., Amgen Inc.
Charles K. Ruck, Esq., Latham & Watkins LLP
Christian W. Nolet, Ernst & Young LLP |
15
Appendix 1
|
|
|
|
|
|
|
|
|
Timing of Entry into |
Molecule |
|
Disease/Condition |
|
Phase* |
Phase 3 Programs |
|
|
|
|
AMG 386
|
|
Ovarian cancer
|
|
11/2010 |
Ganitumab (AMG 479)
|
|
Pancreatic cancer
|
|
4/2011 |
Aranesp® (darbepoetin alfa)
|
|
Anemia in heart failure
|
|
6/2006 |
Motesanib
|
|
First-line non-small cell lung cancer
|
|
7/2007 |
Prolia® (denosumab)
|
|
Male osteoporosis
|
|
10/2009 |
Sensipar®/Mimpara® (cinacalcet)
|
|
Cardiovascular disease in patients with
secondary hyperparathyroidism and chronic
kidney disease undergoing maintenance dialysis
|
|
8/2006 |
Vectibix® (panitumumab)
|
|
First- and second-line colorectal cancer
|
|
6/2006 |
XGEVATM (denosumab)
|
|
Prevention of bone metastases in prostate cancer
|
|
2/2006 |
XGEVATM (denosumab)
|
|
Prevention of bone metastases in breast cancer
|
|
6/2010 |
|
|
|
|
|
Phase 2 Programs* |
|
|
|
|
AMG 386
|
|
Various cancer types
|
|
5/2007-8/2009 |
Ganitumab (AMG 479)
|
|
Various cancer types
|
|
3/2008-2/2010 |
AMG 785
|
|
Bone-related conditions, including
postmenopausal osteoporosis and fracture
healing
|
|
6/2009-6/2010 |
|
|
|
|
|
AMG 827
|
|
Inflammatory diseases
|
|
12/2009-11/2010 |
AMG 853
|
|
Asthma
|
|
12/2009 |
Conatumumab
|
|
Various cancer types
|
|
1/2008-9/2009 |
Denosumab
|
|
Rheumatoid arthritis
|
|
8/2004 |
Motesanib
|
|
First-line breast cancer
|
|
11/2005 |
Nplate® (romiplostim)
|
|
Chemotherapy-induced thrombocytopenia
|
|
2/2006 |
Nplate® (romiplostim)
|
|
Myelodysplastic syndromes
|
|
7/2005 |
Omecamtiv mecarbil (AMG 423)
|
|
Heart failure
|
|
4/2011 |
Rilotumumab (AMG 102)
|
|
Various cancer types
|
|
1/2007-10/2009 |
Sensipar®/Mimpara® (cinacalcet)
|
|
Post Renal Transplant
|
|
12/2009 |
Vectibix® (panitumumab)
|
|
Locally advanced head and neck cancer
|
|
10/2007 |
|
|
|
|
|
Phase 1 Programs |
|
|
|
|
AMG 139
|
|
Inflammatory diseases
|
|
4/2010 |
|
|
|
* |
|
For programs in which multiple potential
indications are being studied, date ranges reflects time period during which
multiple clinical trials were initiated. |
16
|
|
|
|
|
|
|
|
|
Timing of Entry into |
Molecule |
|
Disease/Condition |
|
Phase* |
AMG 145
|
|
Hypercholesterolemia
|
|
7/2009 |
AMG 151
|
|
Type 2 diabetes
|
|
3/2009 |
AMG 157
|
|
Asthma
|
|
10/2008 |
AMG 167
|
|
Bone-related conditions
|
|
5/2009 |
AMG 181
|
|
Ulcerative colitis
|
|
7/2010 |
AMG 191
|
|
Inflammatory diseases
|
|
10/2008 |
AMG 208
|
|
Various cancer types
|
|
12/2008 |
AMG 221
|
|
Type 2 diabetes
|
|
8/2005 |
AMG 319
|
|
Hematologic malignancies
|
|
4/2011 |
AMG 337
|
|
Various cancer types
|
|
12/2010 |
AMG 557
|
|
Systemic lupus erythematosus
|
|
11/2006 |
AMG 745
|
|
Muscle-wasting disorders
|
|
12/2005 |
AMG 747
|
|
Neuroscience
|
|
1/2009 |
AMG 761
|
|
Asthma
|
|
2/2009 |
AMG 780
|
|
Various cancer types
|
|
8/2010 |
AMG 811
|
|
Systemic lupus erythematosus
|
|
12/2007 |
AMG 820
|
|
Various cancer types
|
|
3/2008 |
AMG 888
|
|
Various cancer types
|
|
9/2008 |
AMG 900
|
|
Various cancer types
|
|
8/2009 |
Dulanermin (rhApo2L/TRAIL)
|
|
Various cancer types
|
|
7/2004 |
17