e8vk
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 21, 2008
ELI LILLY AND COMPANY
(Exact name of registrant as specified in its charter)
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Indiana
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001-06351
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35-0470950 |
(State or Other Jurisdiction
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(Commission
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(I.R.S. Employer |
of Incorporation)
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File Number)
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Identification No.) |
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Lilly Corporate Center
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46285 |
Indianapolis, Indiana
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(Zip Code) |
(Address of Principal |
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Executive Offices) |
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Registrants telephone number, including area code: (317) 276-2000
No Change
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On April 21, 2008, we issued a press release announcing our results of operations for the quarter
ended March 31, 2008, including, among other things, an income statement for those periods. In
addition, on the same day we are holding a teleconference for analysts and media to discuss those
results. The teleconference will be web cast on our web site. The press release and related
financial statements are attached to this Form 8-K as Exhibit 99.
We provide non-GAAP financial information that differs from financial statements reported in
conformity to U.S. generally accepted accounting principles (GAAP). In the press release
attached as Exhibit 99, we used non-GAAP financial measures in comparing the financial results for
the first quarter of 2008 with the same period of 2007. Those measures include operating income,
income before taxes, income taxes, effective tax rate, net income, and earnings per share without
the effect of several items affecting the relevant accounting periods:
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The following items in the first quarter of 2007 (described in more detail in our Form
8-K dated April 16, 2007): |
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Restructuring charges associated with previously announced manufacturing decisions. |
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In-process research and development charges associated with the acquisition of ICOS
Corporation (which closed on January 29, 2007) and an in-licensing transaction with OSI
Pharmaceuticals. |
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The following items in the first quarter of 2008 (described in more detail in the press
release attached as Exhibit 99): |
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A tax benefit from resolution of a substantial portion of an IRS audit of the
companys federal income tax returns for the years 2001 to 2004. |
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Asset impairments, restructuring (exit costs), and other special charges primarily
related to the decision to terminate the development of the companys AIR Insulin
program. |
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In-process research and development charges associated with an in-licensing
transaction with BioMS Medical. |
In the press release attached as Exhibit 99, we also provided financial expectations for the full
year 2008. In addition to providing earnings per share expectations on a GAAP basis, we provided
earnings per share expectations as they would have been without certain items. The relevant items
include those described above for the first quarter of 2008 and the items below in 2007:
2
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The following items in the fourth quarter of 2007: |
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Acquired in-process research and development charges for compounds acquired from
Macrogenics and Glenmark. |
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Asset impairments and restructuring related primarily to previously announced site
closures and other special charges related to Zyprexa product liability. |
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A charge for a reduction in our expected product liability insurance recoveries in the
third quarter of 2007. |
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The in-process research and development charges associated with the acquisitions of
Hypnion, Inc. and Ivy Animal Health, Inc. in the second quarter of 2007. |
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The following items in the first quarter of 2007: |
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Restructuring charges associated with previously announced manufacturing decisions. |
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Acquired in-process research and development charges associated with the acquisition
of ICOS Corporation (which closed on January 29, 2007) and an in-licensing transaction
with OSI Pharmaceuticals. |
The items identified above are typically highly variable, difficult to predict, and of a size that
could have a substantial impact on our reported operations for a period. We believe that this
non-GAAP information is useful to investors and may help them evaluate our ongoing operations.
This information can assist in making meaningful period-over-period comparisons and in identifying
operating trends that would otherwise be masked or distorted by these types of items. Management
uses this non-GAAP information internally to evaluate the performance of the business, including to
allocate resources and to evaluate results relative to incentive compensation targets.
Investors should consider this non-GAAP information in addition to, not as a substitute for or
superior to, measures of financial performance prepared in accordance with GAAP. For the reasons
described above for use of non-GAAP information, our prospective earnings may be affected by future
matters, similar to those identified above, as to which prospective quantification generally is not
feasible.
The information in this Item 2.02 and the press release attached as Exhibit 99 are considered
furnished to the Commission and are not deemed filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended.
Item 9.01. Financial Statements and Exhibits
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Exhibit Number |
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Description |
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99
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Press release dated April 21, 2008, together with related attachments |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ELI LILLY AND COMPANY |
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(Registrant) |
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By: |
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/s/ Derica W. Rice |
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Name: |
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Derica W. Rice |
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Title: |
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Senior Vice President and Chief |
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Financial Officer |
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Dated: April 21, 2008 |
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4
EXHIBIT INDEX
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Exhibit Number |
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Exhibit |
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99
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Press release dated April 21, 2008, together with related attachments. |
5
exv99w1
Exhibit 99.1
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Eli Lilly and Company |
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Lilly Corporate Center |
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Indianapolis, Indiana 46285 |
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U.S.A. |
www.lilly.com
Date: April 21, 2008
For Release: Immediately
Refer to: (317) 276-5795 Mark E. Taylor
Lilly Reports Solid First-Quarter Results
Company delivers double-digit sales growth
Eli Lilly and Company (NYSE: LLY) today announced financial results for the first quarter of 2008.
Financial results are presented on both a reported and a pro forma basis. Reported results were
prepared in accordance with generally accepted accounting principles (GAAP) and include all sales
and expenses recognized by the company during the period. Pro forma results assume the ICOS
acquisition was completed January 1, 2007.
First-Quarter Highlights Reported Results
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Sales increased 14 percent, to $4.808 billion. |
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Products launched this decade Alimta®, Byetta®,
Cialis®, Cymbalta®, Forteo®, Strattera®,
Symbyax®, Xigris® and Yentreve® collectively grew
33 percent, to $1.678 billion, and accounted for 35 percent of total sales, compared
with 30 percent of total sales in the first quarter of 2007. |
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Net income and earnings per share grew to $1.064 billion and $.97,
respectively, compared with first-quarter 2007 net income of $508.7 million and
earnings per share of $.47. |
First-Quarter Highlights Pro Forma Results
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Sales increased 12 percent, to $4.808 billion. |
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Sales of products launched this decade collectively grew 26 percent and
represented 35 percent of total sales. |
Product Sales Highlights
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% Change |
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First Quarter |
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Over/(Under) |
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(Dollars in millions) |
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2008 |
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2007 |
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2007 |
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Zyprexa® |
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$ |
1,120.2 |
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$ |
1,108.0 |
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1 |
% |
Cymbalta |
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605.1 |
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441.8 |
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37 |
% |
Gemzar® |
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426.2 |
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376.9 |
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13 |
% |
Humalog® |
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407.4 |
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339.5 |
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20 |
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Cialis1 |
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336.9 |
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193.1 |
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74 |
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Evista® |
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261.1 |
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263.8 |
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(1 |
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Humulin® |
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257.7 |
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225.8 |
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14 |
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Alimta |
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247.2 |
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187.8 |
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32 |
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Forteo |
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185.0 |
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153.4 |
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21 |
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Strattera |
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148.0 |
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139.9 |
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6 |
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Total Sales Reported |
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$ |
4,807.6 |
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$ |
4,226.1 |
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14 |
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Total Sales Pro forma |
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$ |
4,807.6 |
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$ |
4,298.8 |
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12 |
% |
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1 |
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These amounts represent the reported Cialis sales in Lillys financial statements and
do not include Cialis sales from the joint-venture countries prior to the ICOS acquisition on
January 29, 2007. Total worldwide Cialis sales for the first quarter of 2008 of $336.9 million
represent 27 percent growth over the first quarter of 2007. |
Significant Events Over the Last Three Months
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On April 1, 2008, John C. Lechleiter, Ph.D., assumed the role of chief executive officer
of Eli Lilly and Company, replacing Sidney Taurel. Taurel will remain chairman of the
companys board of directors until December 31, 2008, at which time he will retire from the
board and from the company. |
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The company terminated development of its AIR® Insulin program, which was
being conducted in partnership with Alkermes, Inc. The program had been in Phase III
clinical development as a potential treatment for type 1 and type 2 diabetes. Lilly noted
that this decision is not a result of any observations during AIR Insulin trials relating
to the safety of the product, but rather was a result of increasing uncertainties in the
regulatory |
- 2 -
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environment, and a thorough evaluation of the evolving commercial and clinical potential of
the product compared to existing medical therapies. |
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The company received a not-approvable letter from the U.S. Food and Drug Administration
(FDA) for Zyprexa long-acting injection for the treatment and maintenance treatment of
schizophrenia in adults. In its letter, the FDA said it needs more information to better
understand the risk and underlying cause of excessive sedation events that have been
observed in about 1 percent of patients in clinical trials. |
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The FDA accepted and gave priority review status to the New Drug Application for
prasugrel. The company, along with its partner Daiichi Sankyo Company, Limited, is seeking
FDA approval for prasugrel as a treatment for patients with acute coronary syndrome being
managed with percutaneous coronary intervention. The company also recently submitted
prasugrel to the European Medicines Agency (EMEA) for the same indication. |
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The European Commission approved a new indication for Forsteo® for the treatment of
osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at
increased risk for fracture. The company has also received an approvable letter from the
FDA for Forteo for the same indication. |
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The company reached agreement with the state of Alaska to settle a lawsuit filed by the
state over use of Zyprexa by the states Medicaid program. The agreement includes no
admission of wrongdoing on the companys part. |
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The company entered into a licensing and collaboration agreement with Transition
Therapeutics Inc. granting Lilly exclusive worldwide rights to develop and commercialize
Transitions gastrin-based therapies, including the lead compound TT-223, which is
currently in early Phase II testing as a potential treatment for type 2 diabetes. |
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The company launched Humalog KwikPen, a new insulin pen prefilled with the Humalog
brand of insulins. |
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The company initiated enrollment of a Phase III clinical trial studying LY450139, an
investigational gamma-secretase inhibitor for the treatment of mild to moderate Alzheimers
disease. |
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European health authorities approved Alimta in combination with cisplatin as a
first-line treatment for non-small-cell lung cancer patients with other than predominantly
squamous cell histology. |
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The company, along with its partner, Amylin Pharmaceuticals, Inc., submitted Byetta as a
monotherapy treatment for type 2 diabetes to the FDA. |
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The company announced a streamlining of a portion of its manufacturing operations in
Indianapolis and is offering a voluntary exit program to employees in selected areas. In
total, the voluntary program is expected to reduce the companys Indianapolis employment by
up to 500 people, predominantly in manufacturing but with a small portion in selected areas
of research and development. |
Following strong performance in 2007, Lilly continued to deliver solid financial results in the
first quarter of 2008, commented John Lechleiter, Ph.D., Lilly president and new chief executive
officer. Double-digit sales growth was once again primarily driven by volume. The sales growth of
Cymbalta, Cialis, Alimta, Forteo and Humalog was especially encouraging. We also made appropriate
investments in R&D to accelerate the progress of our mid-stage pipeline, resulting in six molecules
advancing to the next stage on clinical development this past quarter, while at the same time
delivering strong earnings per share growth for the quarter.
First-Quarter Reported Results
Worldwide reported sales for the quarter were $4.808 billion, an increase of 14 percent compared
with the first quarter of 2007. Worldwide sales volume increased 8 percent, while exchange rates
and selling prices contributed 5 percent and 1 percent of sales growth, respectively.
Gross margin as a percent of sales decreased by 1.3 percentage points, to 76.9 percent. This
decrease was primarily due to the impact of foreign exchange rates, offset in part by manufacturing
expenses growing at a slower rate than sales.
Overall, marketing, selling and administrative expenses rose 16 percent, to $1.551 billion. This
increase was due to the impact of the ICOS acquisition, increased marketing expenses in support of
key products (primarily Cymbalta, Cialis and Humalog), the impact of foreign exchange rates, and
increased legal costs, including a $15.0 million settlement related to Zyprexa litigation with the
state of Alaska. Research and development expenses were $877.1 million, or 18 percent of sales.
Compared with the first quarter of 2007, research and development expenses grew 5 percent. This
increase was primarily due to increased discovery research and late-stage clinical trial costs,
offset by lower prasugrel clinical trial costs and the first-quarter-2007 costs associated
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with the consequences of the FDAs rejection of Lillys appeal of the approvable letter for
ArxxantTM and the withdrawal of the Arxxant application in Europe.
The company recognized asset impairment, restructuring (exit costs), and other special charges of
$145.7 million in the first quarter of 2008. The charge is primarily related to the decision to
terminate the development of AIR Insulin. Components of this charge include non-cash charges of
$40.9 million for the write-down of impaired manufacturing assets that had no use beyond the AIR
Insulin program, as well as charges of $91.7 million for estimated contractual obligations and
wind-down costs associated with the termination of clinical trials and certain development
activities, and costs associated with the patient program to transition patients from AIR Insulin.
This amount includes an estimate of Alkermes wind-down costs for which the company is
contractually obligated. The wind-down activities and patient programs should be substantially
complete by the end of 2008. The remaining component of this charge, $13.1 million, is related to
exit costs incurred in this quarter related to strategic decisions made in prior periods.
Other income decreased by $18.0 million, to $20.3 million, primarily due to the acquisition of
ICOS. Prior to the acquisition of ICOS, the results of the Lilly ICOS joint venture were presented
in other income. Subsequent to the acquisition, all sales and expenses associated with Cialis are
included in their respective lines on Lillys income statement.
In the first quarter of 2008, the company reported an income tax benefit of $8.0 million. This
income tax benefit includes a discrete benefit of $210.3 million in the first quarter of 2008 that
was a result of the conclusion of a substantial portion of the IRS audit of the companys federal
income tax returns for years 2001 through 2004. The reported effective tax rate for the first
quarter of 2007 was 29.3 percent, because the in-process research and development charge associated
with the acquisition of ICOS was not deductible.
Reported net income and earnings per share increased to $1.064 billion and $.97, respectively,
compared with first-quarter 2007 net income of $508.7 million and earnings per share of $.47 due
primarily to the in-process research and development charge associated with the ICOS acquisition in
the first quarter of 2007 and the resolution of the IRS tax audit in the first quarter of 2008.
First-quarter 2008 reported results also include an $87.0 million charge (pre-tax) related to
acquired in-process research and development associated with the BioMS Medical in-
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licensing transaction, as well as a charge related to asset impairments and restructuring (exit
costs) primarily associated with the termination of the AIR Insulin program.
First-Quarter Pro Forma Results
Worldwide pro forma sales for the first quarter of 2008 were $4.808 billion, an increase of 12
percent compared with the first quarter of 2007. Worldwide pro forma sales volume increased 6
percent, while exchange rates and selling prices contributed 5 and 1 percentage points of the sales
growth, respectively. Gross margin as a percent of sales decreased by 1.3 percentage points, to
76.9 percent. Marketing, selling and administrative expenses and research and development expenses
increased 13 percent and 4 percent, respectively. Total operating expenses, defined as the sum of
research and development, marketing, selling and administrative expenses, grew 9 percent. Other
income increased $3.5 million. The effective tax rate was 22 percent.
Significant Items Affecting Net Income
Net income for the first quarter of 2008 and the first quarter of 2007 were affected by the
following significant items that are reflected in our financial results.
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First Quarter |
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% Growth |
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2008 |
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2007 |
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E.P.S. (reported) |
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$ |
.97 |
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.47 |
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106 |
% |
Benefit from resolution of IRS audit |
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(.19 |
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Asset impairments and restructuring
charges |
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.09 |
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.08 |
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In-process research and development
charges associated with BioMS Medical
in-licensing (2008) and ICOS
acquisition and OSI in-licensing (2007) |
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.05 |
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.29 |
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Pro forma as if the ICOS acquisition
was completed on January 1, 2007 |
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(.01 |
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Totals |
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$ |
.92 |
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$ |
.83 |
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11 |
% |
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Zyprexa
In the first quarter of 2008, Zyprexa sales totaled $1.120 billion, a 1 percent increase compared
with the first quarter of 2007. U.S. sales of Zyprexa decreased 5 percent, to $499.3 million, due
to decreased demand. Zyprexa sales in international markets increased 6 percent, to $620.9 million,
driven by the favorable impact of foreign exchange rates. Demand outside the U.S. decreased
slightly, as the impact of generic competition in Canada and Germany offset growth in Japan and
several European markets.
Cymbalta
For the first quarter of 2008, Cymbalta generated $605.1 million in sales, an increase of 37
percent compared with the first quarter of 2007. U.S. sales of Cymbalta increased 32 percent, to
$511.1 million, driven primarily by strong demand. Sales outside the U.S. were $94.0 million, an
increase of 69 percent, driven primarily by higher demand, as well as the favorable impact of
foreign exchange rates.
Gemzar
Gemzar sales totaled $426.2 million in the first quarter on 2008, an increase of 13 percent from
the first quarter of 2007. Sales in the U.S. increased 8 percent, to $175.7 million, due to higher
prices and increased demand, while sales outside the U.S. increased 17 percent, to $250.5 million,
as a result of the favorable impact of foreign exchange rates and increased demand.
Humalog
For the first quarter of 2008, worldwide Humalog sales increased 20 percent, to $407.4 million.
Sales in the U.S. increased 13 percent to $238.6 million, driven by higher demand and increased
prices. Sales outside the U.S. increased 31 percent to $168.8 million, driven by strong demand and
the favorable impact of foreign exchange rates.
Cialis
Cialis sales for the first quarter of 2008 were $336.9 million. Worldwide sales of Cialis grew 27
percent compared with first-quarter 2007. U.S. sales of Cialis were $123.0 million in the first
quarter, a 25 percent increase compared with the first quarter of 2007, driven by higher prices and
increased demand. Sales of Cialis outside the U.S. increased 28 percent, to $214.0 million, driven
primarily by higher demand and the favorable impact of foreign exchange rates.
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Prior to the acquisition of ICOS on January 29, 2007, Cialis sales in Lilly territories were
reported in Lillys revenue, while Lillys 50 percent share of the joint-venture territory sales,
net of expenses, was reported in Lillys other income. After the acquisition of ICOS, all Cialis
sales are reported in Lillys revenue.
Evista
Evista sales were $261.1 million in the first quarter of 2008, a 1 percent decrease compared with
the first quarter of 2007. U.S. sales of Evista were essentially flat at $171.3 million, as a
result of higher prices, offset by lower demand. Sales outside the U.S. decreased 2 percent, to
$89.8 million, driven by lower demand and lower prices, partially offset by favorable exchange
rates.
Humulin
Worldwide Humulin sales increased 14 percent in the first quarter of 2008, to $257.7 million. U.S.
sales increased 9 percent, to $93.1 million, due to higher prices, partially offset by lower
demand. Sales outside the U.S. increased 17 percent, to $164.6 million, driven by the favorable
impact of foreign exchange rates and increased demand, partially offset by lower prices.
Alimta
For the first quarter of 2008, Alimta generated sales of $247.2 million, an increase of 32 percent
compared with the first quarter of 2007. U.S. sales of Alimta increased 17 percent, to $121.9
million, due primarily to increased demand, while sales outside the U.S. increased 50 percent, to
$125.3 million, due primarily to increased demand and the favorable impact of foreign exchange
rates, partially offset by lower prices.
Forteo
First-quarter sales of Forteo were $185.0 million, a 21 percent increase compared with the first
quarter of 2007. U.S. sales of Forteo increased 10 percent, to $118.3 million, driven primarily by
increased volume caused by variations in wholesaler buying patterns, as well as by higher prices.
Sales outside the U.S. grew 45 percent, to $66.7 million, due to higher demand and the favorable
impact of foreign exchange rates.
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Strattera
During the first quarter of 2008, Strattera generated $148.0 million of sales, an increase of 6
percent compared with the first quarter of 2007. U.S. sales decreased 2 percent, to $115.5 million,
due to a decline in demand, offset in part by higher prices. Sales outside the U.S. increased 47
percent, to $32.6 million, due primarily to higher demand and the favorable impact of foreign
exchange rates.
Other Diabetes Care Products
As previously disclosed, Lillys U.S. marketing rights with respect to Actos® expired in
September 2006; however, Lilly will continue to receive royalties from Takeda Pharmaceuticals North
America at a declining rate through September 2009. Lilly continues to market the product in many
countries outside the U.S. In the first quarter of 2008, Actos generated $84.1 million of revenue
for Lilly, the majority of which was outside the U.S. Actos revenue decreased 2 percent versus the
first quarter of 2007.
Worldwide sales of Byetta were $169.0 million in the first quarter of 2008, a 15 percent increase
compared with the first quarter of 2007. U.S. Byetta sales grew 8 percent, to $158.5 million.
Byetta sales outside the U.S. were $10.5 million. Lilly reports as revenue its 50 percent share of
Byettas gross margin in the U.S., 100 percent of Byetta sales outside the U.S., and its sales of
Byetta pen delivery devices to its partner, Amylin Pharmaceuticals. For the first quarter, Lilly
recognized revenue totaling $82.7 million, representing a 16 percent increase compared with the
first quarter of 2007.
Animal Health
Worldwide sales of animal health products in the first quarter of 2008 were $235.3 million, an
increase of 9 percent compared with the first quarter of 2007. U.S. sales grew 16 percent, to
$107.6 million, driven by the acquisition of Ivy Animal Health, Inc. and the launch of
ComfortisTM, a new companion animal product. Sales outside the U.S. grew 4 percent, to
$127.7 million, driven primarily by the favorable impact of exchange rates.
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2008 Financial Guidance
The companys full-year 2008 earnings guidance is now $3.90 to $4.05 per share. As noted in the
table below, the change from earlier guidance results from the tax benefit of $.19 per share
resulting from the resolution of the IRS tax audit, a $.09 per share charge related to asset
impairments and restructuring (exit costs) primarily related to the termination of the AIR Insulin
program, and a $.05 per share charge related to the in-licensing transaction with BioMS Medical.
Absent these items, the companys expected 2008 earnings per share would have remained in the range
of $3.85 to $4.00. See the table below for further detail. The companys full-year 2008 guidance
does not reflect potential charges related to the recently-announced voluntary exit program.
Excluding the effect of the resolution of the IRS tax audit, the estimated effective tax rate has
been revised to approximately 22 percent from the previously stated 23 percent. This reduction is
the result of a more favorable forecast of the mix of income between the companys domestic and
international operations and the alignment of the companys practices with the conclusions of the
most recent IRS audit. No other elements of the companys previously issued line item guidance
have been changed.
2008 Earnings Per Share Expectations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
Expectations |
|
|
Results |
|
|
% Growth |
|
E.P.S. (reported) |
|
$3.90 to $4.05 |
|
$ |
2.71 |
|
|
44% to 49% |
Benefit from resolution of IRS audit |
|
|
(.19 |
) |
|
|
|
|
|
|
|
|
Asset impairments and restructuring
charges |
|
|
.09 |
|
|
|
.15 |
|
|
|
|
|
Charge for a reduction in expected
insurance recoveries |
|
|
|
|
|
|
.06 |
|
|
|
|
|
In-process research & development
charges associated with BioMS
Medical in-licensing (2008) and
ICOS, Hypnion, and Ivy acquisitions
and OSI, MacroGenics and Glenmark
in-licensings (2007) |
|
|
.05 |
|
|
|
.63 |
|
|
|
|
|
Pro forma as if the ICOS
acquisition was completed on
January 1, 2007 |
|
|
|
|
|
|
(.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
$3.85 to $4.00 |
|
$ |
3.54 |
|
|
9% to 13% |
|
|
|
|
|
|
|
|
|
|
|
Webcast of Conference Call
- 10 -
As previously announced, investors and the general public can access a live webcast of the
first-quarter 2008 financial results conference call through a link on Lillys website at
www.lilly.com. The conference call will be held today from 8:00 a.m. to 9:00 a.m. Eastern Daylight
Time (EDT) and will be available for replay via the website through May 23, 2008.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class
and best-in-class pharmaceutical products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers through medicines and information for some of the
worlds most urgent medical needs. Additional information about Lilly is available at
www.lilly.com; Lillys clinical trial registry is available at www.lillytrials.com.
F-LLY
This press release contains forward-looking statements that are based on managements current
expectations, but actual results may differ materially due to various factors. There are
significant risks and uncertainties in pharmaceutical research and development. There can be no
guarantees with respect to pipeline products that the products will receive the necessary clinical
and manufacturing regulatory approvals or that they will prove to be commercially successful. The
companys results may also be affected by such factors as competitive developments affecting
current products; rate of sales growth of recently launched products; the timing of anticipated
regulatory approvals and launches of new products; regulatory actions regarding currently marketed
products; other regulatory developments and government investigations; patent disputes and other
litigation involving current and future products; the impact of governmental actions regarding
pricing, importation, and reimbursement for pharmaceuticals; changes in tax law; asset impairments
and restructuring charges; acquisitions and business development transactions; and the impact of
exchange rates. For additional information about the factors that affect the companys business,
please see the companys latest Form 10-K filed February 2008. The company undertakes no duty to
update forward-looking statements.
# # #
Actos® (pioglitazone hydrochloride, Takeda)
AIR® (Alkermes, Inc.)
Alimta® (pemetrexed, Lilly)
Arxxantä (ruboxistaurin mesylate, Lilly)
Byetta® (exenatide injection, Amylin Pharmaceuticals)
Cialis® (tadalafil, Lilly)
ComfortisTM (Lilly)
Cymbalta® (duloxetine hydrochloride, Lilly)
Evista® (raloxifene hydrochloride, Lilly)
Forsteo® (teriparatide of recombinant DNA origin injection, Lilly)
Forteo® (teriparatide of recombinant DNA origin injection, Lilly)
Gemzar® (gemcitabine hydrochloride, Lilly)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Humulin® (human insulin of recombinant DNA origin, Lilly)
KwikPenTM (Lilly)
Strattera® (atomoxetine hydrochloride, Lilly)
- 11 -
Symbyax® (olanzapine fluoxetine combination, or OFC, Lilly)
Xigris® (drotrecogin alfa (activated), Lilly)
Yentreve® (duloxetine hydrochloride, Lilly)
Zyprexa® (olanzapine, Lilly)
Eli Lilly and Company Employment Information
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Worldwide Employees |
|
|
40,300 |
|
|
|
40,600 |
|
- 12 -
Eli Lilly and Company
Operating Results (Unaudited) REPORTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31 |
|
|
|
2008 |
|
|
2007 |
|
|
% Chg. |
|
Net sales |
|
$ |
4,807.6 |
|
|
$ |
4,226.1 |
|
|
|
14 |
% |
Cost of sales |
|
|
1,111.3 |
|
|
|
922.5 |
|
|
|
20 |
% |
Research and development |
|
|
877.1 |
|
|
|
834.2 |
|
|
|
5 |
% |
Marketing, selling and
administrative |
|
|
1,550.5 |
|
|
|
1336.8 |
|
|
|
16 |
% |
Acquired in-process research
and development |
|
|
87.0 |
|
|
|
328.5 |
|
|
|
N/M |
|
Asset impairments,
restructuring and other special
charges |
|
|
145.7 |
|
|
|
123.0 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,036.0 |
|
|
|
681.1 |
|
|
|
52 |
% |
Net interest income (expense) |
|
|
(3.5 |
) |
|
|
4.0 |
|
|
|
|
|
Joint-venture income |
|
|
0.0 |
|
|
|
11.0 |
|
|
|
|
|
Net other income |
|
|
23.8 |
|
|
|
23.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
20.3 |
|
|
|
38.3 |
|
|
|
|
|
Income before income taxes |
|
|
1,056.3 |
|
|
|
719.4 |
|
|
|
47 |
% |
Income taxes |
|
|
(8.0 |
) |
|
|
210.7 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,064.3 |
|
|
$ |
508.7 |
|
|
|
109 |
% |
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.97 |
|
|
$ |
0.47 |
|
|
|
106 |
% |
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.97 |
|
|
$ |
0.47 |
|
|
|
106 |
% |
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
0.47 |
|
|
$ |
0.425 |
|
|
|
11 |
% |
Weighted-average shares
outstanding (thousands)
basic |
|
|
1,093,866 |
|
|
|
1,089,732 |
|
|
|
|
|
Weighted-average shares
outstanding (thousands)
diluted |
|
|
1,094,056 |
|
|
|
1,089,879 |
|
|
|
|
|
N/M not meaningful
- 13 -
Eli Lilly and Company
Operating Results (Unaudited) PRO FORMA
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31 |
|
|
|
2008 |
|
|
2007(a) |
|
|
% Chg. |
|
Net sales |
|
$ |
4,807.6 |
|
|
$ |
4,298.8 |
|
|
|
12 |
% |
Cost of sales |
|
|
1,111.3 |
|
|
|
938.4 |
|
|
|
18 |
% |
Research and development |
|
|
877.1 |
|
|
|
846.2 |
|
|
|
4 |
% |
Marketing, selling and
administrative |
|
|
1,550.5 |
|
|
|
1372.7 |
|
|
|
13 |
% |
Acquired in-process research
and development |
|
|
87.0 |
|
|
|
328.5 |
|
|
|
N/M |
|
Asset impairments,
restructuring and other special
charges |
|
|
145.7 |
|
|
|
123.0 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,036.0 |
|
|
|
690.0 |
|
|
|
50 |
% |
Net interest income (expense) |
|
|
(3.5 |
) |
|
|
(65.5 |
) |
|
|
|
|
Joint-venture income |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
|
|
Net other income |
|
|
23.8 |
|
|
|
82.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
20.3 |
|
|
|
16.8 |
|
|
|
|
|
Income before income taxes |
|
|
1,056.3 |
|
|
|
706.8 |
|
|
|
49 |
% |
Income taxes |
|
|
(8.0 |
) |
|
|
209.6 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,064.3 |
|
|
$ |
497.2 |
|
|
|
114 |
% |
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.97 |
|
|
$ |
0.46 |
|
|
|
111 |
% |
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.97 |
|
|
$ |
0.46 |
|
|
|
111 |
% |
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
0.47 |
|
|
$ |
0.425 |
|
|
|
11 |
% |
Weighted-average shares
outstanding (thousands)
basic |
|
|
1,093,866 |
|
|
|
1,089,732 |
|
|
|
|
|
Weighted-average shares
outstanding (thousands)
diluted |
|
|
1,094,056 |
|
|
|
1,089,879 |
|
|
|
|
|
N/M not meaningful
|
|
|
(a) |
|
In accordance with generally accepted accounting principles (GAAP), the 2007 financial
statement has been restated assuming the acquisition of ICOS was completed by Lilly
effective January 1, 2007. |
- 14 -