NEW YORK, Dec. 10 /PRNewswire-FirstCall/ -- -- Company remains
focused on speeding innovation to patients and delivering greater
value to customers. -- Five strategic business units prepared to
maximize growth opportunities in multiple therapeutic areas and
geographies. -- Lilly advances ranking to ninth in worldwide
pharmaceutical sales; fastest growing top 10 pharma company in the
U.S., major Europe and globally. -- R&D pipeline boasts more
than 60 molecules in clinical development, including 25 in Phases
II and III. -- Company expects 10 Phase III molecules in 2011,
plans to launch 2 new medicines per year beginning in 2013. --
Continued strong cash flow expected to fund R&D investment and
business development transactions, while at least maintaining the
current dividend. -- 2010 EPS guidance set at $4.65 to $4.85,
excluding the potential impact of health care reform in the U.S. --
Longer-term guidance reconfirmed at low double-digit compound
annual EPS growth between 2007 and 2011 At its annual meeting today
with the investment community, Eli Lilly and Company (NYSE:LLY)
highlighted how its innovation-based strategy will enable it to
better serve patients and compete effectively in a challenging
health care environment. The company also detailed the progress
being made in its labs and across its five new business units on an
expanding pipeline of innovative molecules and marketed medicines,
and provided investors with the company's financial guidance for
2010. "In 2009, Lilly has once again exhibited strong performance
in a tough environment, and we've continued with a series of
actions aimed at speeding innovation to patients and delivering
greater value to our customers," said John C. Lechleiter, Ph.D.,
Lilly's president and chief executive officer. "Through these
actions and more, we are transforming Lilly to compete and to win
in an ever more demanding and challenging environment. We see a
divergence of strategies among our peers to deal with these
challenges, including the wave of consolidation this year. Many
companies are seeking to lower risk by reducing their focus on
innovative medicines. This is not our path. Our strategy is to
create value by accelerating the flow of innovative new medicines
that provide improved outcomes for individual patients. We aim to
discover, develop, or acquire innovative new therapies - medicines
that make a real difference for patients and deliver clear value
for payers." Steven M. Paul, M.D., executive vice president,
science and technology and president of Lilly Research
Laboratories, reinforced the company's commitment to innovation. "I
believe that there's never been a more compelling case for
innovative medicines. Our strategy is dependent upon our pipeline
of potential medicines. I am encouraged by the fact that today we
have the strongest pipeline in our history. We currently have more
than 60 new molecules in clinical development, including 25 in
Phases II and III, targeting unmet medical needs in areas such as
Alzheimer's disease, cancer and diabetes, among others. We are
excited by both the quantity and the quality of these molecules,
and their potential to improve patient's lives." Paul expanded on
the efforts being made in Lilly's research and development
organization. "By ramping up our efforts in discovery research, we
have nearly doubled the number of new molecules moving into the
clinic each and every year. As a result, we have tripled the number
of potential new medicines in our clinical pipeline since 2004.
Through the acquisition of ImClone and other actions, we have
increased our portfolio of biotechnology-based molecules, which now
represents over one-third of our clinical-stage pipeline. We are
also applying creative approaches to every point in the R&D
chain to develop more medicines more quickly at lower cost.
Initiatives such as our phenotypic drug discovery program (PD2),
numerous risk-sharing collaborations, the early-stage work of our
virtual Chorus team and our new Development Center of Excellence
will further accelerate development, and increasingly tailor
molecules for those patients most likely to benefit from them.
Through these efforts, we expect to have at least 10 molecules in
Phase III clinical development by the end of 2011 and plan to
launch two new medicines per year beginning in 2013 and to sustain
a steady flow of innovation thereafter." Derica Rice, Lilly senior
vice president and chief financial officer, provided commentary on
the company's current financial performance and forward-looking
expectations. "Lilly is completing another year of strong operating
performance, delivering solid earnings growth resulting from
volume-based sales growth, improving gross margins and tightening
control of operating expenses. Looking ahead to 2010, we expect to
once again deliver good sales and earnings growth, excluding the
potential impact of health care reform legislation in the U.S. We
also expect to generate solid cash flow in the coming years to fund
continued investment in research and development, as well as to
fund our dividend and anticipated business development activity. We
continue to expect to deliver low double-digit compound annual
earnings-per-share growth between 2007 and 2011. We are taking the
steps necessary to prepare our operations for the upcoming
challenges of patent expiries. We are committed to becoming leaner,
more focused, more customer-oriented and more competitive." Based
on IMS Health data(1), for the 12 months ending June 2009, Lilly
has moved into the ninth spot among the top 10 companies ranked by
worldwide pharmaceutical sales. Among these top 10 companies, Lilly
was the fastest growing globally and the fastest growing in the
United States and major Europe; the fourth-fastest growing in the
pharmerging markets; and the sixth-fastest growing in Japan. The
company recently refocused its operations around five business
units to create a clear line of sight to the customer. The five
business units cover oncology, diabetes, established markets,
emerging markets and animal health. The following sections
highlight each of these five business units, including the
performance of key marketed products and updates on the status of
select late-stage and mid-stage pipeline molecules. (1) IMS Health
data for Europe does not include Spain hospital data. IMS Health
data for the pharmerging mar-kets does not include India, Russia or
hospital data for Brazil, Mexico or Turkey. Established Markets The
established markets business unit is the company's largest. It will
operate in the U.S., Europe, Japan, Canada, Australia and New
Zealand, and includes the neuroscience, cardiovascular and
musculoskeletal therapeutic areas, as well as the autoimmune
disease platform. Currently, this unit accounts for more than half
of the company's revenues and more than half of its clinical stage
pipeline. The company's two best-selling medicines, Zyprexa® and
Cymbalta®, are part of this business unit, as are several important
growth products, including Cialis® and Effient(TM). The established
markets pipeline includes Phase II and Phase III molecules
targeting Alzheimer's disease, schizophrenia, depression and
rheumatoid arthritis, among others. Cymbalta sales for the first
three quarters of 2009 have grown 13 percent in the U.S. and 15
percent internationally. The U.S. demand for Cymbalta has been
aided by improved payer access in 2009, due in large part to
achieving Tier 2 unrestricted status with two significant
commercial payers. In the U.S., Cymbalta continues to outperform
other promoted medicines in an antidepressant and pain market that
has seen increasing use of generics and relatively modest growth
overall. Cymbalta's international growth has been driven by recent
approvals for depression in new markets, complemented by growth
from other indications in existing markets. Plans are in place to
enter the Japanese market in the near future. Cymbalta is under
regulatory review for chronic pain in the U.S., and was recently
approved by both Mexico and Brazil for this indication. The company
expects additional international regulatory submissions in 2010.
Zyprexa continues to be the company's best-selling medicine. More
than half of Zyprexa's sales now come from international markets,
although U.S. Zyprexa sales still grew 4 percent in the first nine
months of 2009. Zyprexa has obtained approvals for additional
indications in the U.S. in 2009, and awaits final action from the
FDA on Zyprexa Relprevv®, or long-acting injection. Lilly
re-launched Zyprexa in Germany in early 2009 after the successful
appeal of a patent decision. Share of market is stable in other EU
countries and continues to grow in Japan. In other Asian nations,
including China, the company expects current strong sales trend to
continue. Cialis (tadalafil) continues to demonstrate solid growth.
Over the first three quarters of 2009, Cialis has grown 4 percent
to $1.1 billion in sales worldwide, while the global ED market has
grown only 1 percent. In the U.S., Cialis has grown 17 percent and
has achieved market leadership with urologists. Internationally,
Cialis is now available in more than 100 countries and is the
market leader in more than 20, including 6 of the top 8
international markets. Tadalafil also has been studied for
pulmonary arterial hypertension (PAH) and benign prostatic
hyperplasia (BPH). The PAH indication was approved by the FDA in
May and launched in August by Lilly's partner, United Therapeutics,
under the brand name Adcirca(TM). In October, Lilly received PAH
approval in Japan, where it has partnered with Nippon Shinyaku. In
November, Lilly received PAH approval in Europe and Canada. Lilly
maintains full rights to the PAH indication in all markets outside
of the U.S. and Japan. The BPH Phase III program is ongoing and
will complete recruitment late next year. The company expects to
submit for approval of the BPH indication in the U.S. and Japan in
2011, and in the EU in 2012. With the launches of Effient in the
U.S. and Europe earlier this year for treatment of patients with
acute coronary syndrome (ACS) undergoing percutaneous coronary
intervention (PCI), the company is optimistic about its potential
in this important market segment. In the U.S., Lilly and
Daiichi-Sankyo launched Effient in early August and are diligently
executing sales and marketing plans to gain payer and hospital
formulary access. Outside the U.S., Lilly and Daiichi Sankyo
launched Efient in Germany and the U.K. in April 2009. The
companies anticipate launches in France, Italy and Spain in 2010.
Lilly has also launched Efient in Australia and Argentina, and
anticipates launching the medicine in 24 additional countries
outside of the U.S. and Europe in 2010. Lilly and Daiichi-Sankyo
are also pursuing additional ongoing studies, including the TRILOGY
ACS study in medically managed patients. Key molecules in the
established markets business unit pipeline include: -- Semagacestat
- This gamma secretase inhibitor is currently being studied in two
large multi-national pivotal Phase III trials - IDENTITY and
IDENTITY-2 - to assess its effect on the progression of Alzheimer's
disease. Enrollment in the IDENTITY trial was completed in the
third quarter of 2009 and includes over 1,500 patients in 20
different countries. Enrollment in IDENTITY-2 is progressing
rapidly and is expected to be completed in the first half of 2010.
-- Solanezumab - A monoclonal antibody, the company's A-beta
antibody holds the potential for slowing down the progression of
Alzheimer's disease. Enrollment began in May 2009 in two
multi-national Phase III registration studies - EXPEDITION and
EXPEDITION 2. Each study will enroll 1,000 subjects for an 18-month
treatment duration. -- mGlu 2/3 Prodrug - An open-label study
continues for this potential schizophrenia compound currently in
Phase II of clinical development. The company plans to proceed with
further efficacy testing, and anticipates initiating two large
studies in the first half of 2010. -- iGluR5 Receptor Antagonist -
Work on this pain compound continues to progress. Phase II studies
began in osteoarthritis and diabetic peripheral neuropathic pain in
the second quarter of 2009. Other pain indications are also being
considered, including migraine prevention. -- Insomnia Compound
LY2624803 - A Phase II study is ongoing and recently completed
enrollment ahead of plan. Results are expected in the first half of
2010. -- IL-17 antibody - This molecule continues to be studied for
its potential in rheumatoid arthritis (RA) and in other autoimmune
disorders. In August, a Phase IIb trial for IL-17 was initiated in
RA designed to further elucidate the molecule's safety and efficacy
and to establish a dosing regimen for Phase III trials. This trial
is expected to conclude in early 2011. -- BAFF antagonist -
Enrollment was recently completed in two Phase II clinical trials
for rheumatoid arthritis and, earlier this year, a Phase II study
was initiated in patients with relapsing-remitting multiple
sclerosis. Oncology With the acquisition of ImClone and the
progression of its own pipeline, Lilly is well along the way to
building an oncology powerhouse. Within the oncology business unit,
Lilly's three key cancer medicines - Alimta®, Gemzar® and Erbitux®
- account for 14 percent of the company's worldwide revenue. Lilly
also has one of the largest clinical stage oncology pipelines in
the industry, with 23 assets - more than one-third of the total
pipeline. The need for new and better treatments is staggering: the
World Health Organization estimates 12 million cancer-related
deaths per year by 2030. Over the first three quarters of 2009,
Alimta has been the company's fastest growing product, reaching
worldwide sales of $1.2 billion. U.S. sales have grown 46 percent,
driven by market share growth in nonsquamous non-small cell lung
cancer (NSCLC). Outside the U.S., Alimta has grown 37 percent. The
company plans to pursue additional indications for Alimta, either
as monotherapy, or in combination with other oncolytics. Gemzar
sales have exceeded $1.0 billion in the first three quarters of
2009. In the U.S., Gemzar remains the standard of care for
pancreatic cancer, and has held steady in NSCLC. Gemzar lost patent
exclusivity in Europe in March of 2009, resulting in rapid generic
penetration. Gemzar continues to grow in other markets, including
Japan and China. The company continues to work with its partners,
Bristol Myers Squibb and Merck KGaA, to maximize the growth
potential of Erbitux. Erbitux is currently approved in certain
indications for colorectal cancer and head and neck cancer. It is
being studied for additional indications for these cancers, as well
as lung cancer, gastric cancer and others. Key molecules in the
oncology business unit pipeline include: -- Ramucirumab (IMC-1121B)
- Enrollment in a global Phase III study in first-line breast
cancer is ongoing, and a second Phase III study in gastric cancer
began enrollment in October 2009. Two to three additional Phase III
ramucirumab studies are projected to begin in 2010. Several
additional Phase II trials are expected to be initiated next year,
including trials in brain and bladder cancers and additional
studies in colorectal and breast cancers. This is in addition to
Phase II trials that have been initiated in renal cancer, melanoma,
and cancers of the liver, lung, colon, ovary and prostate. --
Necitumumab (IMC- 11F8) - Two Phase III studies of necitumumab have
been initiated in non-small cell lung cancer. The first of these
commenced dosing in November 2009 and the second study is expected
to commence before the end of 2009. A pivotal trial in colorectal
cancer will follow. -- Cixutumumab (IMC-A12) - Phase II testing of
cixutumumab continues in breast, prostate, colorectal, liver,
neuroendocrine and head and neck cancers, as well as sarcoma. Phase
III trials of cixutumumab in various tumor types are planned to
begin in 2010. -- Enzastaurin - Enzastaurin is currently being
evaluated in a Phase III clinical trial for maintenance therapy for
diffuse large B-cell lymphoma. U.S. regulatory submission remains
targeted for mid-2013. Enzastaurin is also being evaluated in
several Phase II studies for hematologic malignancies and
glioblastoma. -- Tasisulam - A Phase III study of tasisulam in 2nd
line metastatic melanoma was initiated in the fourth quarter of
2009. Tasisulam was also recently granted orphan drug designation
for melanoma by the FDA. Additional cancers being explored in
tasisulam clinical trials include breast, ovarian, lung and renal
cancers as well as acute leukemia. -- Survivin ASO - Currently in
Phase II, this second-generation antisense oligonucleotide (ASO) is
being studied in prostate cancer and acute myeloid leukemia.
Additional Phase II studies in other tumor types are expected to
begin during the first half of 2010. -- IMC-3G3 - A Phase II study
of 3G3 was initiated in 2009 in ovarian cancer and a second Phase
II trial is planned in 2010 in lung cancer. A Phase 1 trial was
completed in 2009 in prostate cancer. Diabetes Lilly has long been
a leader in diabetes care, and has refocused its efforts in this
important therapeutic area with the creation of a diabetes business
unit that includes a dedicated asset base and a portfolio of
commercially-successful products and promising pipeline
opportunities. Lilly is one of only a few companies positioned to
compete globally in the insulins business. The company remains
firmly committed to its insulins franchise and is making the
investments necessary in key geographies to further strengthen its
competitive position. In addition, Lilly intends to maintain a
leading role in the rapidly emerging area of GLP-based therapy. The
need for new and improved treatments for patients with diabetes is
great: an estimated 285 million people are expected to be affected
worldwide in 2010. Humalog® sales for the first three quarters of
2009 have grown 12 percent worldwide, including 21 percent growth
in the U.S. market. Humalog has continued to show growth in total
prescriptions in the U.S. over the past year. In addition, the
company continues to launch its flagship pre-filled pen, Humalog
KwikPen(TM), in markets around the world, and will continue to do
so in 2010. Byetta® remains the first and only GLP-1 receptor
agonist available in the U.S. market. Since the initial effects of
last year's FDA safety alert on Byetta's U.S. performance, the
company and its partner, Amylin Pharmaceuticals, have slowed the
erosion of prescriptions and are focused on returning Byetta to
growth. Internationally, Byetta has been launched in approximately
60 countries, including most major markets. The company is pleased
with the uptake of Byetta in many markets, including the major five
European markets. Byetta was recently launched in China and is
under regulatory review in Canada and Japan. Key molecules in the
diabetes business unit pipeline include: -- Exenatide once weekly -
The company continues to develop exenatide once weekly with its
partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. The
companies submitted exenatide once weekly for U.S. regulatory
review in the second quarter of 2009. The application was accepted
for review by the FDA in the third quarter of 2009. Regulatory
action is expected by the end of the first quarter of 2010.
European submission is expected to occur by the end of the second
quarter of 2010. -- GLP-Fc - An adaptive, seamless Phase II/III
trial, comparing GLP-Fc with both placebo and a positive control,
sitagliptin, is proceeding. The company is also finalizing its full
Phase III clinical program, known as AWARD, and will begin
enrolling patients in the first quarter of 2010. To address the
recent FDA guidance regarding mitigation of cardiovascular (CV)
risk, a large CV outcomes trial is planned that will likely begin
in the first quarter of 2011. Based on the company's current
expectations, GLP-Fc could be submitted for U.S. regulatory review
as early as late-2012. -- Teplizumab- The safety and efficacy of
teplizumab is currently being studied in both children and adults
with newly-diagnosed type 1 diabetes mellitus in two global,
pivotal Phase III clinical trials - Protégé and Protégé Encore. The
Protégé trial completed enrollment in 2009. Patients who have
completed the two-year protocol are currently transitioning into an
extension phase evaluating the long-term safety and durability of
teplizumab. Protégé Encore, the second global pivotal Phase III
clinical trial began enrolling patients in June 2009. Regulatory
submission could occur in 2012. Emerging Markets The emerging
markets business unit will include many of the world's
fastest-growing markets, including six of the so-called
"pharmerging markets" - China, Russia, Brazil, Mexico, South Korea,
and Turkey. Lilly aims to increase its presence in these countries
and others where strong growth rates for pharmaceuticals are
projected over the next decade. The creation of an emerging markets
business unit will increase the company's focus on these areas and
best position Lilly to serve growing patient needs among two-thirds
of the world's population. This opportunity comes as the
established pharmaceutical markets face slower growth. According to
an analysis published by IMS, the seven pharmerging markets (the
six named above plus India) will contribute over a third of global
pharmaceutical market growth through 2013. Currently, these markets
accounted for 9 percent of the company's revenue in the first nine
months of 2009. The company has a three-part strategy aimed at
driving profitable growth in the emerging markets: 1. Maximize
Lilly's core assets, including both patented and post-patent
medicines. Two key tactics are to accelerate new product launches
and to capitalize on longer product lifecycles in select countries
such as China. 2. Add select non-Lilly medicines to build upon core
therapeutic areas, especially diabetes, oncology and neuroscience,
to accelerate top-line growth. This could include product
acquisitions and co-promotion or co-marketing agreements. 3.
Establish local alliances to more effectively access fast-growing
market segments in select countries where the company's current
infrastructure is not well suited to capture growth. The company's
top emerging market priority is China. In 2009, the company
significantly expanded its presence in China. Lilly is currently
the 11th ranked multi-national pharmaceutical company in China,
with sales of over $200 million in 2008. Through the first nine
months of 2009, Lilly's sales in China grew 20 percent, the company
doubled the size of its affiliate from 1,100 to about 2,200
employees, and is currently building a second manufacturing plant
in Suzhou to produce insulin. Animal Health The animal health
business unit provides both diversification and growth potential to
the company's operations. Elanco is currently the sixth largest
animal health company in the industry and its sales continue to
grow at a rate faster than the overall animal health market,
bolstered by recent acquisitions and the launch of its companion
animal business. Year-to-date 2009 animal health sales exceeded
$850.0 million. Elanco maintains the top position in the medicated
feed additives and dairy segments and also ranks first in research
and development output in the U.S., delivering more new molecules
over the past six years than any other company in its industry. In
the companion animal segment, Elanco is growing faster than the
competition, driven by the growth of Comfortis®. In 2010, Elanco is
planning for 7 new product launches and expanded indications,
including two new companion animal products. Elanco is positioned
to double revenue in five years with five strategic initiatives: 1.
Increased investment and industry leadership in innovation; 2.
Continued growth and increased presence in the companion animal
business, 3. Greater investment and focus on emerging market
opportunities; 4. Transforming its manufacturing cost structure to
better support innovation growth and emerging market opportunities;
and 5. A further-enhanced business unit model to amplify "best in
industry" employee engagement and focused execution. With strategic
investments in research and development, along with focused efforts
to accelerate growth in key emerging markets and the companion
animal segment, Elanco is positioned to deliver double-digit annual
income growth over the next five years. 2009 Financial Guidance The
company confirmed its current financial guidance for 2009. The
company expects its full-year 2009 earnings per share to be in the
range of $3.90 to $4.00 on a reported basis, or $4.30 to $4.40 on a
pro forma non-GAAP basis. 2009 Earnings Per Share Expectations:
2009 2008 Expectations Results % Growth ------------ -------
-------- Earnings (Loss) per share (reported) $3.90 to $4.00
($1.89) NM Financial impact of ImClone acquisition, including in-
process research and development and other charges - 4.46 Charges
related to Zyprexa litigation .13 1.20 Asset impairments and
restructuring charges (included in asset impairments, restructuring
and other special charges) .26 .30 Asset impairments (included in
cost of sales) - .04 In-process research and development charges
associated with SGX acquisition and in- licensing transactions with
BioMS and TransPharma - .10 Benefit from resolution of IRS audit in
the first quarter of 2008 - (.19) Pro forma as if the ImClone
acquisition was completed on January 1, 2008 - (.20) --------------
------- Earnings per share (pro forma non-GAAP) $4.30 to $4.40
$3.82 13% to 15% -------------- ------- NM - not meaningful Numbers
in the 2009 Expectations column do not add due to rounding The
company expects low- to mid-single digit total revenue growth on a
pro-forma basis and mid-single digit revenue growth on a reported
basis. The company expects gross margin as a percent of total
revenue to increase for the full year, driven primarily by the
beneficial foreign exchange impact in the first nine months of 2009
compared to the first nine months of 2008. For the fourth quarter
of 2009, the company expects a decrease in gross margin as a
percent of total revenue compared to the fourth quarter of 2008.
Marketing, selling, and administrative expenses are projected to
show flat to low-single digit growth. Research and development
expenses are projected to grow in the high-single digits on a pro
forma non-GAAP basis and in the low-double digits on a reported
basis. Other income is expected to be a net loss of between $200
million and $250 million. The effective tax rate is expected to be
approximately 21 percent on a pro forma non-GAAP basis and
approximately 20 percent on a reported basis. Capital expenditures
are expected to be less than $1.0 billion. The company expects
continued strong operating cash flow. 2010 Financial Guidance The
company provided financial guidance for 2010, excluding the
potential impact of health care reform in the U.S. In 2010, the
company expects earnings per share of $4.65 to $4.85 on both a
reported and pro forma non-GAAP basis. 2010 Earnings Per Share
Expectations: 2010 2009 Expectations Expectations % Growth
------------ ------------ -------- Earnings per share (reported)
$4.65 to $4.85 $3.90 to $4.00 16% to 24% Charges related to Zyprexa
litigation - .13 Asset impairments and restructuring charges
(included in asset impairments, restructuring and other special
charges) - .26 -------------- -------------- Earnings per share
(pro forma non-GAAP) $4.65 to $4.85 4.30 to $4.40 6% to 13%
-------------- -------------- The company expects volume-driven
revenue growth in the high-single digits, driven primarily by
Alimta, Cymbalta, Humalog, Cialis, Effient and the exenatide
franchise. The company anticipates that gross margin as a percent
of revenue will be flat to declining. Excluding the effect of
foreign exchange rates on international inventories sold, the
company expects gross margin as a percent of revenue to increase.
Marketing, selling and administrative expenses are projected to
grow in the low- to mid-single digits while research and
development expenses are projected to grow in the low-double
digits. Other income is expected to be a net loss of between $150.0
and $200.0 million, and the tax rate is expected to be
approximately 22 percent. Cash flows are expected to be sufficient
to fund capital expenditures of approximately $1.0 billion,
anticipated business development activity and the company's
dividend. Longer-term Financial Commentary The company reaffirmed
its commitment to deliver low double-digit compound annual earnings
per share growth between 2007 and 2011, excluding the potential
impact of health care reform in the U.S. Looking further out, the
company also provided a general perspective on possible financial
performance during the major patent expiry years of 2012 to 2014
and beyond. During this time, the company anticipates annual
revenue of at least $20.0 billion. Gross margins as a percent of
revenue could be between 75 and 80 percent. Operating expenses, the
sum of selling, general and administrative expenses and research
and development expenses, as a percent of revenue could be in the
mid 50s. The tax rate could be higher than today, possibly 25
percent. Under this scenario, net income would exceed $3.0 billion
and operating cash flow would exceed $4.0 billion. This level of
operating cash flow would solidly position the company to fund
research and development, capital expenditures and the dividend. As
the company plans for this challenging time period, it believes it
will generate sufficient operating cash flow to enable it to
execute on its innovation-based strategy, reward shareholders and
successfully and independently emerge from the major patent expiry
years with bright prospects for future growth. Webcast of
Investment Community Meeting A live webcast of the Lilly Investment
Community meeting, along with presentation slides, is available
through a link on Lilly's web site at http://www.lilly.com/. The
meeting will start today at 8:30 a.m. Eastern Time and last until
approximately 12:30 p.m. The webcast will be available for replay
through January 8, 2010. Lilly, a leading innovation-driven
corporation, is developing a growing portfolio of 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
world's most urgent medical needs. More information about Lilly is
available at http://www.lilly.com/. C-LLY This press release
contains forward-looking statements that are based on management's
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 company's results may also be affected by such factors as
competitive developments affecting current products; the rate of
sales growth of recently launched products; the timing of
anticipated regulatory approvals and launches of new 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; business
development transactions; changes in tax law; asset impairments and
restructuring charges and the impact of exchange rates. For
additional information about the factors that affect the company's
business, please see the company's latest Form 10-K, filed February
2009, and Form 10-Q filed October 2009. The company undertakes no
duty to update forward-looking statements. Alimta® (pemetrexed,
Lilly) Adcirca(TM) (tadalafil, Lilly) Byetta® (exenatide injection,
Amylin Pharmaceuticals) Cialis® (tadalafil, Lilly) Comfortis(TM)
(Lilly) Cymbalta® (duloxetine hydrochloride, Lilly) Effient(TM)
(prasugrel, Lilly) Erbitux® (cetuximab, ImClone Systems, Lilly)
Gemzar® (gemcitabine hydrochloride, Lilly) Humalog® (insulin lispro
injection of recombinant DNA origin, Lilly) KwikPen(TM) (Lilly)
Zyprexa® (olanzapine, Lilly) Zyprexa Relprevv® (olanzapine depot
injection, Lilly) (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGODATASOURCE: Eli
Lilly and Company CONTACT: Mark Taylor (media), +1-317-354-7045,
Phil Johnson (investors), +1-317-655-6874, or Angela Sekston
(media), +1-317-332-1593
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