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www.lilly.com
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Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
VIA EDGAR
July 12, 2010
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporate Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
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Re:
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Eli Lilly and Company |
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Form 10-K for the Fiscal Year Ended December 31, 2009 |
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File Number 001-06351 |
Dear Mr. Rosenberg:
Eli Lilly and Company (Lilly) submits this response to your letter dated June 7, 2010 commenting on
our Form 10-K for the year ended December 31, 2009, our DEF 14A filed March 8, 2010, and our Form
10-Q for the quarter ended March 31, 2010. For ease of reference we have repeated your comments
prior to our responses.
Comment:
Item 7. Managements Discussion and Analysis of Results of Operations and Financial
Condition
Executive Overview, page 18
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For each project discussed on pages 19 and 20 related to your late-stage
pipeline that you deemed significant, as well as for each project in the earlier stages
of development that you deem significant, please revise your disclosure to address the
following : |
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The nature, objective, and current status of the project and the extent that
its success relies on parties other than you; |
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The costs incurred during each period presented and to date; |
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The nature, timing and estimated costs of the efforts necessary to complete
the project; |
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The anticipated completion dates; |
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The risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and liquidity
if the project is not completed timely; and |
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The period in which material net cash inflows from significant projects are
expected to commence. |
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Please disclose your criteria for deeming a project significant. For the remainder of
projects that you do not deem significant, summarize the number of programs and cost for
each period by therapeutic category or other descriptive class/category showing
preclinical versus clinical, and provide an estimate of the nature, timing and cost to
complete these programs. |
Response:
Pharmaceutical research and development is lengthy and highly uncertain. The process from
discovery to regulatory approval typically takes 12 to 15 years or longer, and very few discoveries
ever become approved medicines. Even after a potential drug begins human testing (Phase I clinical
trials), the historical odds of it becoming an approved drug are only 10 to 15 percent. Because of
the long timelines and uncertainties surrounding the early pipeline, we have focused our
disclosures on late stage projects (which we define as projects in Phase III clinical trials having
a 60%-70% probability of being approved for sale and projects submitted for regulatory review),
with only general information regarding the earlier stages of our pipeline. Our historical
practice has been to provide in the MD&A updates on late-stage projects at significant milestones:
beginning of Phase III, suspension or termination of the project, filing for regulatory approval,
and any response to our filings from the regulatory agency. We believe this practice provides
investors with the information they need to understand our pipeline, based upon knowledge of
current FDA review and approval trends. This is also the information they need to anticipate when
the project might begin to generate positive cash flows.
Approval and Launch Timelines. We follow industry practice, to not provide specific
estimates of timelines for approval and launch of individual projects in development. There are
several reasons for this. First, we do not believe this type of disclosure is required. Second, we
do not want to make our specific product approval and launch timelines public for competitive
reasons. Finally, there is significant risk and uncertainty in drug development and regulatory
review. This uncertainty makes it very difficult to estimate timelines with any degree of accuracy,
even within a 12 18 month window due to scientific and regulatory delays (many of which may be
out of our control), and raises concerns that estimates of timing could even be misleading by
implying a greater degree of certainty than actually exists.
We have historically disclosed a summary of drug candidates in development by the stage of clinical
trials (e.g., Phase I, II, or III). These disclosures normally have been made in the annual
report, in Investor Relations presentations, and on our corporate website. We have an extensive
pipeline of new drug candidates, including a current portfolio of more than 60 potential new drugs
in human testing and over 100 earlier stage products. Given our historical practice, the reasons
discussed in the paragraph above, and the fact that each project represents
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only a small portion of
our overall pipeline, none of which individually is significant or material, we do not believe it
is appropriate to single out any of these projects for disclosure of anticipated timing. However,
in future filings we will include, and update as necessary, a listing and description of the
molecules in Phase III clinical testing in our pipeline and those under regulatory review.
Additionally, we will provide expected FDA submission dates when the submission timing becomes
reasonably definite, which is contingent on various factors (i.e. clinical trial results,
enrollment and results, data requests from regulators, etc).
Project Costs. You also requested additional disclosure regarding historical cost incurred
and the nature and estimated cost of the efforts necessary to complete the projects. We believe
the disclosure of the phase the projects are in (i.e. Phase II or Phase III clinical trials)
informs the reader of the nature of the efforts necessary to complete the projects (completion of
clinical trials). We expect the cost of each of the individual products in development not to be
significant or material to our consolidated R&D expense on an annual basis. We will include in
future filings, starting with the 2010 Form 10-K under Item 1, Description of Business, a
description of each phase of development (i.e. Phase I, Phase II, and Phase III) and the general
time period of each phase to give investors who may not be familiar with pharmaceutical development
greater insights as to both the nature of the activities and the timing of movement through the
phases of development.
We operate in an industry in which the risk of failure of research projects in development is very
high. One way in which we manage this risk is by investing in a diversified portfolio of research
projects. With regard to the impact of delays on our results of operations and financial condition,
it is unlikely, due to the long-term nature of the project, that delays or failure in any one of
these individual projects would have a material impact on our results of operations or
financial condition in the near term; however, we would make appropriate disclosure if the impact
were to be material. We address these R&D related risks in Item 1 (page 8) and Item 1a (page 11)
of our Form 10-K.
We manage our R&D spend in total. A delay in or termination of one project will not by itself
necessarily cause us to significantly change our total R&D spend. Our current practice has been to
provide in the our MD&A (under Financial Expectations) of our Form 10-Qs and Form 10-K, guidance
of the range of our anticipated total R&D expense for the current year along with other line item
earnings estimates. We generally initiate subsequent year guidance beginning with a press release
issued in December of the prior year (e.g., guidance on 2010 R&D expense was provided in a press
release issued in December 2009). These press releases are furnished in a Form 8-K. We update this
guidance as necessary on a quarterly basis in MD&A.
In conclusion, we will expand our disclosures in accordance with your suggestions to the extent
that we believe such additional information would be considered by a reasonable investor to be
important to the understanding of our business, financial condition, and results of operations.
These additional disclosures would include the three items referred to above as well as other
changes responsive to your comments if and when they become material to our company in the future.
Comment:
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Financial Condition, page 25
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You disclose that the loss of patent exclusivity could result in a rapid and
severe decline in revenue from the affected products. Please revise to disclose the
factors that will determine whether this decline will be rapid and severe. Please
include in your discussion the ease or difficulty for other companies to develop
generic products. To the extent that you are aware of any competitors products in
development and nearing commercialization that are expected to compete with any of your
key patented-protected products when exclusivity ends in the next three years, please
disclose as applicable. Further, please include disclosure to support your assertion
that the growth in your remaining business will mitigate the effect of the loss of
revenues from the products that will lose effective exclusivity. This disclosure
should specify why you believe this is to be true and provide specifics of where the
growth will come from and to what extent. |
Response:
Patent protection of pharmaceutical products is critical to success in the research-based
pharmaceutical industry. As we have disclosed for several years in Item 1 of our Form 10-K, with
the exception of biologic products, the introduction of generic products upon the loss of patent
exclusivity is common in the industry, generally resulting in a rapid and severe decline in the
related branded products revenue. This has long been true in the U.S. but has a growing impact
outside the U.S. as well. We experienced this issue with the loss of patent exclusivity in 2001
for Prozac in the United States and more recently Zyprexa and Gemzar outside the United States.
This impact has been discussed in previous Form 10-Ks (Zyprexa specifically discussed in our 2008
Form 10-K and Gemzar in our 2009 Form 10-K).
In considering our disclosure in the 2009 Form 10-K, we recognized that we are entering a unique
period because several products will lose patent exclusivity in the next several years. These
patent expiration dates are widely known to investors, having been previously disclosed in Item 1
of our Form 10-K (in 2009 on page 5, under Our Intellectual Property Portfolio) for many years.
However, we determined it was now appropriate to bring greater prominence to this issue in MD&A as
well as Item 1A, Risk Factors. Thus, we included in our Financial Condition section of MD&A a
specific reference to the expected expiries in 2010 and 2011, as well as an expanded discussion in
Risk Factors of the expected expiries through 2017.
While generic product introductions are common in our industry, it is not for us to determine the
ease or difficulty for other companies to develop and secure approvals for generic products.
For competitive reasons, we do not discuss product development or manufacturing details with
generic drug companies. We do not know, in terms of time spent or cost, the extent of research and
development these companies perform to develop a generic product. We generally do know, however,
which generic manufacturers are seeking approvals for generic versions of our products because of
(a) the Paragraph IV notices they must provide us under the Hatch Waxman laws if they seek to
challenge our U.S. patents (see our discussion of this in Item 1 of our 10-K under Patents and
Intellectual Property Protection), or (b) public notices
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from the FDA of preliminary approvals
granted to generic companies prior to expiration of our patents. We discuss those notices and the
Hatch Waxman patent litigation for our key products both in the MD&A (beginning on page 31 of the
2009 Form 10-K) and Footnotes (beginning on page 71 of the 2009 Form 10-K), listing the companies
known to be seeking approval from the FDA. In future filings, we will provide a specific
cross-reference in other sections of our Form 10-K to the Hatch Waxman patent litigation
discussion. We have disclosed in past filings, on Form 10-K, that generic forms of Zyprexa and
Gemzar are being marketed in countries outside the U.S. We would expect rapid and severe declines
in the revenues of those branded products following the loss of patent exclusivity because supplies
of generic substitutes are available.
We expect that the impact of the revenue lost from loss of patent exclusivity through 2012 will be
mitigated by the growth of our existing business. We expect this growth to come from
existing products that do not lose exclusivity during this period, as well as growth in emerging
markets, Japan, and our animal health segment. Due to the risks and uncertainties of our business,
we do not believe it is appropriate to project revenue on a product by product basis; however, we
believe that it would be significant for investors to know our view on an overall basis even if we
do not discuss specifics. We do not propose to provide product-specific forward-looking
information. We generally provide disclosure if we expect trends to change materially and will
continue to do so. We provide macro growth trends of our sales annually in Financial Condition
section of our Form 10-K and we believe this is sufficient disclosure.
In conclusion, we believe our disclosure is adequate and appropriately signals to investors the
upcoming expected loss of patent exclusivity. However, going forward we will provide in MD&A
additional language that cross references to other sections of our Form 10-K our discussion of
pending patent litigation and known potential generic competition. We will also note that the
near-term mitigation of patent loses is expected to come from growth in patent-protected products,
the emerging markets, Japan and our animal health segment. We will continue to monitor the loss of
and challenges to our branded product patent protection, providing updates in future filings.
Additionally, we will continue to provide and update financial guidance when information is
available and known.
Comment:
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You disclose that you plan to reduce your expected cost structure by $1 billion
by the end of 2011. Please disclose the nature of the efficiencies and the estimated
amount of these reductions in expenses by line item for 2010 and 2011. |
Response:
The context of our stated goal to reduce the cost structure by $1 billion is a reduction from
our then anticipated 2011 spend, as opposed to historical actual cost. Progress toward this goal
is in various stages depending upon affected areas; some business areas are in the execution stage
while others are in the planning and design stage. In future filings we will give additional
details by disclosing, This savings will come from a series of actions, including reducing a
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targeted 5,500 positions by the end of 2011 (excluding strategic sales force additions in
high-growth emerging markets and Japan), outsourcing activities, and consolidating certain
activities to become more efficient. We expect the majority of the savings to occur in the
marketing, selling and administrative line item in the consolidated statement of operations, and to
a lesser extent cost of sales and R&D.
To the extent any savings will be realized in 2010, the portion of the estimated amount of these
reductions is already reflected in our financial expectations for 2010 (page 30 of our Form 10-K).
We periodically update our guidance as additional facts become known or significant events occur,
which will include updating the impact of the cost structure reductions in future quarterly and
annual filings, as necessary. We will do the same for our financial expectations for 2011 when
more information is known. We do not plan to reconcile the precise $1 billion of savings in future
filings because it is a savings versus prior internal plans, which were never made public. In
future filings, we will note that the impact of our projected savings is already embedded in our
forward-looking guidance. If cost containment efforts are material to comparisons of operating
results in any period, we will note this for each affected income statement line item in our future
MD&A filings.
Comment:
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Item 8. Financial Statements and Supplementary Data
Segment Information, page 39 |
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Please revise your disclosure to include the amount of revenue from each major
customer as required by ASC 280-10-50-42 for all three years for which financial
statements are presented. |
Response:
In future filings, we will include the range of revenue from each major customer for all three
years for which an income statement is presented, in accordance with ASC 280-10-50-42. We also
note that the percentages have not changed materially for several years.
Comment:
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Notes to Consolidated Financial Statements
Note 2: Implementation of New Financial Accounting Pronouncements, page 46 |
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Please note that the FASB Accounting Standards Codification became effective on
July 1, 2009. As a result, all non-SEC accounting and financial reporting standards
have been superseded. Please revise any references to accounting standards accordingly
such as the reference to the provisions of a FSP on page 47. |
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Response:
We eliminated most of the references to non-SEC accounting and financial reporting standards, but
we believe in this section it was appropriate to include these references during the transition
year. In light of this comment, in future filings we will not refer to superseded non-SEC
accounting and financial reporting standards.
Comment:
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Note 12: Income Taxes, page 65 |
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Since the amount of deferred tax assets classified as Other represents
approximately 16% of total deferred tax assets as of December 31, 2009, please disclose
the significant items that are included in this balance. |
Response:
None of the deferred tax asset items aggregated in Other for 2009 exceeded $70 million. Given
the balance of our deferred tax assets (over $3.1 billion), deferred tax liabilities (over $2.6
billion) and the size of our balance sheet overall (over $27 billion in assets), we determined
these were not significant enough to require separate disclosure. On an annual basis, we review
what is material based on the account balance, modifying the disclosure threshold if there is a
significant change, and analyze the components of the other category to verify that there are no
significant items.
Comment:
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Note 13: Retirement Benefits, page 67 |
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Level 3 assets of your defined benefit pension plans at December 31, 2009
comprise 35% of total plan assets. Please disclose the inputs used to determine the
fair value of Level 3 plan assets. Refer to ASC 715-20-50-1. |
Response:
We will modify our future presentation, beginning in our 2010 Form 10-K, to include a summarized
description of the inputs used to determine the fair value of Level 3 plan assets.
Comment:
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You disclose Including the investment losses due to overall market conditions
in 2001, 2002, and 2008, our 20-year annualized rate of return on our U.S. defined
benefit pension plans and retiree health benefit plan was approximately 8.3 percent as
of December 31, 2009. Please revise your disclosure to explain the extent to which
the overall rate of return on plan assets assumption of 8.8 percent and 9.0 |
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percent for
2009 and 2008, respectively was based on historical returns, the extent to which
adjustments were made to those historical returns in order to reflect expectations of
future returns, and how those adjustments were determined as required by ASC
715-20-50-1. |
Response:
Rather than using past performance, we and our investment partners conduct a strategic asset
allocation study every 3 to 4 years. We base our expected return on these asset allocation studies
rather than past performance. With this in mind, we will modify our presentation to reflect this
focus on future expectations, as noted by the revised language below that we will include in our
2010 Form 10-K.
In evaluating the expected return on plan assets, we conduct an asset allocation study every 3 to
4 years to determine our overall investment strategy and our expected rate of return going
forward based on long term views of asset class returns and expected volatility. Annually, we
review and compare our assumptions with historical results, current market conditions, our current
and expected asset allocations, and consider the views of leading financial advisers and economists
for future asset class returns.
Comment:
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Please disclose the assumptions used in the determination of expense amounts
for all three years for which a statement of operations is presented as required by ASC
715-20-50-1. |
Response:
We will modify our future presentation to include the assumptions for all three years for which a
statement of operations is presented.
Comment:
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DEF 14A filed December 29, 2009 |
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Executive Compensation |
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Compensation Discussion and Analysis, page 28 |
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You disclose that the compensation committee considered individual performance
in setting base salary and target grant values. You also disclose that individual
performance takes into account accomplishment of certain objectives that had been
established at the beginning of the year, however, your analysis does not disclose the
individual performance goals used to determine your executive officers base |
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salary or
target grant values within the companys equity incentive programs. Please provide us
with draft disclosure for your 2011 proxy statement which provides your 2010 individual
performance goals for each of your named executive officers. To the extent the
objectives are quantified, the discussion in your proxy statement should also be
quantified. Please also confirm that in your 2011 proxy
statement you will discuss the achievement of the performance goals and provide a
discussion of how the level of achievement will affect the actual determination of base
salary to be paid and equity incentive target grant values. |
Response:
As discussed between Bronwen Mantlo of our office and Karen Ubell of the Commission staff, the
compensation committee determines base salary and target equity grant values at the beginning of
each calendar year, taking into account individual performance for the just-concluded calendar
year. In setting base salary and target grant values for 2010, the committee considered the
performance of the named executive officers for 2009; thus, our 2011 proxy will contain a
discussion of 2009 individual performance.
The Role of Individual Performance Objectives in Salary and Equity Targets. Each named
executive officer establishes personal objectives for the year. In the case of the CEO, the
objectives are agreed upon between the CEO and the independent directors; in the case of the
remaining NEOs, the objectives are agreed upon between the NEO and the CEO. At the end of the
year, the parties measure progress relative to the objectives. The committee considers this data
along with other data in its subjective judgment of the overall individual performance of the NEO.
Other data considered typically includes assessments of the individuals commitment to ethics,
integrity, and diversity, the contribution of the executive to the companys long-term future, the
leadership demonstrated by the executive at the corporate level, and achievement of business
results other than those specified in the objectives. The committee exercises judgment in
determining the impact of individual performance on salary and equity targets; the process is not
formulaic.
Your comment can be interpreted to request us to disclose each NEOs complete list of
objectives and accomplishments relative to those objectives in effect, to publicize the
individuals performance appraisals. We recognize that shareholders should have a reasonable
understanding of how NEOs individual performance affected their compensation, and we are prepared
to provide additional information on our NEOs accomplishments relative to their objectives.
However, we believe that detailed disclosure of the type your comment appears to suggest would be
inappropriate and detrimental to shareholder interests, as it could lead to disclosure of
competitively sensitive information, violate reasonable expectations of employee privacy, damage
morale, and lead to retention problems. Issuers faced with such detailed disclosures would be
tempted to homogenize the objective-setting process for NEOs to avoid damaging disclosures an
ironic result that certainly cannot be in the shareholders best interests. Our concerns about
excessively detailed disclosure regarding individual performance would apply to any compensation
program, but they apply with particular force where, as in Lillys case, individual performance is
used not as part of a formula but as an input into the committees collective, overall judgment
about compensation amounts.
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For the 2011 proxy, we propose disclosure along the following lines in connection with the impact
of NEOs individual performance on salary and equity targets:
The Committees Processes and Analyses
The compensation committee uses several tools to help it structure compensation programs that meet
company objectives. Among those are:
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Assessment of individual performance. |
The independent directors, under the direction of the lead director, meet with the CEO in private
session at or near the beginning of the year to agree upon the CEOs performance objectives for the
year. At the end of the year, the independent directors meet with the CEO and in executive session
to assess the performance of the CEO based on his or her achievement of the agreed-upon objectives,
other accomplishments, contribution to the companys performance, ethics and integrity, and other
leadership attributes.
For the other executive officers, the committee receives a performance assessment and compensation
recommendation from the CEO and also exercises its judgment based on these inputs and also on the
boards interactions with the executive officer. As with the CEO, the executives performance is
assessed based on the executives achievement of objectives established between the executive and
the CEO, the executives other accomplishments, contribution to the companys performance, ethics
and integrity, and other leadership attributes.
Base Salary
In setting base salaries for 2010, the committee considered the following:
. . . .
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Individual Performance. Base salary increases were based in
part on individual performance assessments for 2009 as described above under
The Committees Processes and Analyses. The committee applied its judgment
in determining the impact of individual performance on base salary increases.
The committee considered these 2009 accomplishments: |
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John C. Lechleiter Under Dr. Lechleiter
leadership, the company: |
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Delivered strong pro forma revenue growth (5 percent actual
vs. 3 percent plan) and pro forma non-GAAP EPS growth (16
percent actual vs. 8 percent plan) |
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Held the growth of marketing, selling and administrative
expense at a rate slower than sales while increasing our
investment in research and development as a percentage of sales |
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Exceeded its targeted product pipeline milestones (100
actual vs. 84 targeted) |
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Announced and began implementation of sweeping
organizational changes designed to speed development, improve
competitiveness in key therapeutic areas and geographies, and
reduce our cost base |
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Effectively integrated the ImClone acquisition, the largest
in the companys history. |
The committee also noted Dr. Lechleiters successful accomplishment of his objectives to implement
the Corporate Integrity Agreement and reinforce ethics and compliance across the company, engage
with the new Administration and Congress on matters of importance to Lilly, continue to place
emphasis on business development, ensure robust succession management plans for all key roles, and
as incoming chairman, foster continued effectiveness of the Lilly board of directors and board
processes.
Notwithstanding Dr. Lechleiters strong performance, the committee agreed with Dr. Lechleiters
request that his base salary and incentive plan targets not be increased for 2010.
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Bryce N. Carmine The committee noted that under Mr.
Carmines leadership of the sales and marketing organization, worldwide revenue
growth of 5 percent exceeded plan as noted above with all geographic regions
contributing to above-plan growth, notwithstanding slower than expected initial
sales of Effient. Cost-containment measures led to sales and marketing
expenses growing only 1 percent, slightly below plan. The committee also noted
Mr. Carmines successful accomplishment of his objective to reinforce a culture
of high performance with high integrity in the sales and marketing organization
and his strong leadership in the companys organizational redesign efforts. |
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Jan N. Lundberg Dr. Lundberg began employment with the
company in January 2010. |
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Derica W. Rice Under Mr. Rices leadership as chief
financial officer, expense reduction efforts contributed to the above-plan
earnings growth noted above, despite below-plan results of the Elanco animal
health segment. In addition, the company strengthened its balance sheet
through strong operating cash flows, careful management of capital
expenditures, and the successful refinancing (in a difficult financial market)
of the short-term debt incurred in 2008 to acquire ImClone. The committee also
noted Mr. Rices successful accomplishment of his objectives to ensure proper
internal controls and financial compliance and to drive business transformation
efforts, his commitment to diversity and succession management, and his
leadership role in the design of the companys new global shared services
functions. |
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Robert A. Armitage The committee noted Mr. Armitages
successful accomplishment of his objectives to mitigate the companys risks
related to several legal matters, including Zyprexa-related litigation matters,
the |
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defense of the companys worldwide patents on Lilly products, and the
implementation of the companys Corporate Integrity Agreement. In addition,
the committee recognized Mr. Armitages continued industry leadership in
shaping intellectual property laws and policies to foster pharmaceutical
innovation, his support for diversity, succession management initiatives, and
his commitment to ethics and integrity. |
. . . .
Equity Incentives
. . . .
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Target Grant Values. For 2009, the committee established target grant values based
on . . . individual performance (as described above under Base Salary), . . . |
Comment:
Form 10-Q for the quarter ended March 31, 2010
Notes to Consolidated Condensed Financial Statements
Note 4: Collaborations
Boehringer Ingelheim, page 11
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In March 2010 you terminated your collaborative marketing agreement with
Boehringer Ingelheim (BI). Your disclosure states in connection with the arrangement,
we paid BI approximately $400 million and will also pay a royalty to BI on our sales in
these countries through 2012. We record these costs as intangible assets and will
amortize to marketing, selling and administrative expenses over the life of the
original agreement, which is through 2015. Please provide us your basis for
capitalizing the $400 million payment as an asset and tell us the useful life of the
asset. Also, please explain why it would not be appropriate to expense the royalties
as incurred. Finally, please revise your disclosure in MD&A to describe how the
termination will affect sales of Cymbalta including the expected effect on results of
operations and financial position. |
Response:
As background, we originally identified the compound duloxetine and began developing it as a drug.
In 2002, we entered into an arrangement with BI pursuant to which they acquired the rights to
co-develop and jointly market duloxetine in certain countries, primarily major Europe (Marketing
Rights). In accordance with the terms of the arrangement, BI would share in the promotional
efforts and costs, and receive a share of the duloxetine revenue in the form of a co-promotion
fee in the countries in which they co-promoted the product. These rights and obligations were to
extend through the life of the patent in each of the countries. In 2004, duloxetine was launched
under the brand name Cymbalta. We manufactured and supplied
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duloxetine to the market, and recorded the sales of the product in the countries where we
co-promoted along with BI.
In the first quarter of 2010, we reacquired the Marketing Rights previously licensed to BI through
termination of the original agreements. (Because BI had originally acquired the rights to jointly
market duloxetine through a license agreement, the legal form of our reacquisition of the rights
was termination of the license agreement.) By reacquiring the Marketing Rights, we now have
exclusive rights to market duloxetine in the countries that were previously shared with BI through
the patent expiration. We have also been relieved of having to share with BI the revenue generated
from sales of duloxetine for the remaining term of the original agreement. We will retain all
future duloxetine revenue, thereby providing incremental cash flow. As a consequence, the
Marketing Rights reacquired meet the conceptual definition of an asset because with the Marketing
Rights come probable future economic benefits in the form of incremental positive cash flows.
The concepts statements provide the following characteristics of an asset:
An asset has three essential characteristics: (a) it embodies a probable future benefit that
involves a capacity, singly or in combination with other assets, to contribute directly or
indirectly to future net cash inflows, (b) a particular entity can obtain the benefit and control
others access to it, and (c) the transaction or other event giving rise to the entitys right to
or control of the benefit has already occurred. Assets commonly have other features that help
identify themfor example, assets may be acquired at a cost and they may be tangible, exchangeable,
or legally enforceable. However, those features are not essential characteristics of assets. Their
absence, by itself, is not sufficient to preclude an items qualifying as an asset. That is, assets
may be acquired without cost, they may be intangible, and although not exchangeable they may be
usable by the entity in producing or distributing other goods or services. Similarly, although the
ability of an entity to obtain benefit from an asset and to control others access to it generally
rests on a foundation of legal rights, legal enforceability of a claim to the benefit is not a
prerequisite for a benefit to qualify as an asset if the entity has the ability to obtain and
control the benefit in other ways.
The Marketing Rights we reacquired had the three characteristics of an asset: (a) they will
contribute directly to future net cash inflows, (b) we control the Marketing Rights and without
them, no other party can market Cymbalta, and (c) the transaction giving rise to our control of the
Marketing Rights has already occurred (it was effective in the first quarter of 2010). Based on
this analysis, we concluded that the Marketing Rights reacquired met the conceptual definition of
an asset and, therefore, the cost of reacquiring the Marketing Rights should be capitalized as an
intangible asset.
Our cost of acquiring these Marketing Rights was $400 million up-front plus contingent payments in
the form of a royalty paid on sales in certain countries through 2012. This was not a penalty or
termination cost. This was the negotiated cost of reacquiring the Marketing Rights from BI. We
capitalized the $400 million at the time of the transaction. Any additional amounts to be paid out
as contingent consideration will also be capitalized as part of the cost of the asset. The useful
life of the asset is the period in which incremental positive cash flows will be generated the
remaining term of the original agreement. We previously disclosed that this is through 2015.
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We did not address the impact of this transaction on sales of Cymbalta or the expected effect on
results of operations and financial position in our first quarter MD&A because it is not expected
to be material to our revenues, operating results, or financial position. If it was anticipated to
be material, we would have updated our financial guidance for the year. We will address the impact
in future filings if it becomes material.
As requested, we acknowledge that:
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We are responsible for the adequacy and accuracy of the disclosure in our
filing; |
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Staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and |
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Eli Lilly 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. |
If you have any questions about these responses or require additional information, please contact
me at 317-276-2024.
Sincerely,
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ELI LILLY AND COMPANY
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/s/ Arnold C. Hanish
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Arnold C. Hanish |
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Vice President, Finance and
Chief Accounting Officer |
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