Icos (NASDAQ:ICOS)
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ICOS Corporation (Nasdaq:ICOS) today announced that, in advance of the
special meeting of its shareholders on December 19, 2006, it is
providing preliminary financial estimates for the fourth quarter and
full year 2006, a preliminary financial outlook for 2007 and a
development update. The purpose of the special meeting will be to
consider and vote upon a proposal to approve the Agreement and Plan of
Merger, which was unanimously approved by the company's board of
directors on October 16, 2006, with Eli Lilly and Company (NYSE:LLY),
whereby Lilly will acquire all of the outstanding stock of ICOS for a
purchase price of $32 per share in cash.
In light of the pending merger with Lilly, ICOS believes it is important
to update its shareholders on the expected financial performance of
Lilly ICOS LLC and the company for the fourth quarter and full year 2006
and its preliminary outlook for Lilly ICOS LLC and the company for 2007.
For the quarter and year ending December 31, 2006, ICOS currently
estimates the following ranges of worldwide Cialis®
(tadalafil)(a) net product sales, net income
for Lilly ICOS LLC and net income and diluted earnings per share for
ICOS:
4Q 2006
2006
Worldwide Cialis Net Sales (millions)
$255-$265
$955-$965
Lilly ICOS LLC Net Income (millions)
$90-$100
$310-$320
ICOS Net Income (millions) (1)
$11-$15
$21-$25
ICOS Diluted Earnings Per Share (1)
$0.17-$0.22
$0.33-$0.38
(1) Presented on a fully-taxed basis,
assuming a 35% effective income tax rate. Primarily because of net
operating loss carryforwards, ICOS does not expect to recognize or
pay significant income taxes in 2006. Based on expected tax rates,
ICOS estimates a range of fourth quarter 2006 net income of $17
million-$22 million and a range of fourth quarter 2006 diluted
earnings per share of $0.26-$0.34. Based on expected tax rates,
ICOS estimates a range of full year 2006 net income of $32
million-$37 million and a range of full year 2006 diluted earnings
per share of $0.49-$0.57.
Results for the fourth quarter of 2006 will not necessarily be
indicative of results in future periods. Historically, due to the timing
of sales, expenses and other factors, the company’s
fourth quarter results have reflected certain seasonal effects.
For 2007, ICOS’ current outlook for worldwide
Cialis net product sales, net income for Lilly ICOS LLC and net income
and diluted earnings per share for ICOS are set forth in the table
below. ICOS cautions that these projections are subject to significant
risks and uncertainties as they involve numerous assumptions, including
the absence of any significant adverse events. Actual results in 2007
could differ materially from the outlook below.
2007
Worldwide Cialis Net Sales (millions)
$1,100-$1,150
Lilly ICOS LLC Net Income (millions)
$410-$445
ICOS Net Income (millions) (2)
$52-$63
ICOS Diluted Earnings Per Share (2)
$0.78-$0.94
(2) Presented on a fully-taxed basis,
assuming a 35% effective income tax rate. Primarily because of net
operating loss carryforwards, ICOS does not expect to recognize or
pay significant income taxes in 2007. Based on expected tax rates,
ICOS estimates a range of 2007 net income and diluted earnings per
share of $78 million-$94 million and $1.17 per share-$1.41 per
share, respectively.
The estimates for ICOS and Lilly ICOS LLC for 2006 and 2007 are based on
2006 average foreign currency exchange rates and do not include any
costs related to the pending merger with Lilly. These estimates reflect
solely the views of ICOS management and do not necessarily reflect the
views of Lilly.
Cialis Once-A-Day Update
As anticipated, Lilly ICOS LLC has submitted a supplemental New Drug
Application (sNDA) to the Food and Drug Administration (FDA) for 5 mg
and 2.5 mg once-a-day dosing for Cialis (tadalafil) for the treatment of
erectile dysfunction (ED). Cialis is currently approved for the
treatment of ED on an as-needed basis.
Research and Development Update
ICOS continues to evaluate possible new product candidates in its
discovery and preclinical research programs. Previously, the company
stated that its two most advanced discovery and preclinical research
compounds were expected to enter initial clinical safety studies in late
2006 or early 2007. As expected, the company has begun dosing patients
with an oral leukocyte function-associated antigen one (LFA-1)
antagonist, that is potentially useful in the treatment of psoriasis, in
a Phase 1 clinical study. ICOS continues to expect that it will begin
dosing patients with a cell cycle checkpoint/DNA repair inhibitor, that
has the potential to improve the effectiveness of radiation and
chemotherapy treatments, in a Phase 1 study in late 2006 or early 2007.
The company currently estimates that, even assuming success in
preclinical testing, it will take at least 12 months before its next
preclinical program could begin clinical testing.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. ED affects an estimated 189
million men worldwide(3). Experts believe that
80-90 percent of ED cases are related to a physical or medical
condition, like diabetes, cardiovascular diseases, and prostate cancer
treatment, while 10-20 percent are due to psychological causes(4)(5).
In many cases, however, both psychological and physical factors
contribute to the condition(6).
About Cialis
Cialis® (tadalafil)
is approved for the treatment of erectile dysfunction, and is the only
oral ED tablet clinically proven to work up to 36 hours. Cialis is
available by prescription only and is not for everyone. Men taking
nitrates, often used for chest pain, should not take Cialis. Such a
combination could cause a sudden, unsafe drop in blood pressure. The
most common side effects with Cialis were headache, upset stomach,
delayed backache or muscle ache. As with any ED tablet, in the rare
event of priapism (an erection lasting more than four hours), men should
seek immediate medical attention to avoid long-term injury. Men should
not drink alcohol in excess with Cialis.
Cialis does not protect a man or his partner from sexually transmitted
diseases, including HIV. In rare instances, men taking prescription ED
tablets (including Cialis) reported a sudden decrease or loss of vision.
It's not possible to determine if these events are related directly to
the ED tablets or to other factors. If a man has a sudden decrease or
loss of vision, he should stop taking any ED tablet and seek immediate
medical attention. Men should discuss their medical conditions and all
medications with their doctors to ensure Cialis is right for them and
that they are healthy enough for sexual activity.
Individual results may vary. Cialis has not been studied for multiple
attempts per dose. For full patient information and/or full prescribing
information, visit http://www.cialis.com.
About ICOS Corporation
ICOS Corporation, a biotechnology company headquartered in Bothell,
Washington, is dedicated to bringing innovative therapeutics to
patients. ICOS is working to develop treatments for serious unmet
medical conditions such as benign prostatic hyperplasia, pulmonary
arterial hypertension, cancer and psoriasis. Additional information
about ICOS is available at www.icos.com.
Except for historical information contained herein, this press release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
concerning expected future results of operations. In some cases, you can
identify forward-looking statements by terminology such as "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend," "may,"
"might," "plan," "possible," "potential," "predict," "should" or "will"
or the negative of such terms or other comparable terminology.
Forward-looking statements are only predictions that provide our current
expectations or forecasts of future events. These forward-looking
statements involve risks and uncertainties that may cause our results
and the timing and outcome of events to differ materially from those
expressed in or implied by the forward-looking statements, including
risks associated with product commercialization, research and clinical
development, regulatory approvals, manufacturing, collaboration
arrangements, liquidity, competition, intellectual property claims,
litigation and other risks detailed in our latest Quarterly Report on
Form 10-Q and our other public filings with the Securities and Exchange
Commission.
Any or all of our forward-looking statements in this press release and
in any other public statements that we make may turn out to be wrong.
Inaccurate assumptions we might make and known and unknown risks,
uncertainties and other factors may cause our actual results,
performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, based on the
information available to us at the time the statements are made, we
cannot guarantee future results, performance or achievements. You should
not place undue reliance on these forward-looking statements.
The forward-looking statements contained in this press release represent
our judgment as of the date of this release. Except as required under
federal securities laws and regulations, we undertake no obligation to
publicly update any forward-looking statements, whether as a result of
new information, future events or otherwise. The biotechnology and
pharmaceutical businesses are risky and there can be no assurance that
any of our products or product candidates will achieve commercial
success or that competing therapies will not pre-empt market
opportunities that might exist for any of our products or product
candidates.
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Where to Find Additional Information About the Proposed Acquisition by
Eli Lilly and Company
A special shareholder meeting will be held on December 19, 2006 to
obtain shareholder approval of the proposed transaction. ICOS has filed
with the Securities and Exchange Commission and distributed to its
shareholders a definitive proxy statement and other relevant documents
in connection with the special shareholder meeting for the proposed
transaction. ICOS shareholders are urged to read the definitive proxy
statement and other relevant materials because they contain important
information about ICOS, Lilly and the proposed transaction. Investors
may obtain a free copy of these materials and other documents filed by
ICOS with the Securities and Exchange Commission at the SEC’s
website at www.sec.gov, at ICOS’
website at www.ICOS.com or by sending
a written request to ICOS at 22021 20th Avenue SE, Bothell, Washington
98021, attention: General Counsel.
ICOS and its directors, executive officers and certain other members of
management and employees may be deemed to be participants in soliciting
proxies from its shareholders in favor of the proposed merger.
Information regarding the persons who may, under the rules of the SEC,
be considered to be participants in the solicitation of ICOS’
shareholders in connection with the proposed transaction is set forth in
ICOS’ definitive proxy statement for its
special meeting. Additional information regarding these individuals and
any interest they have in the proposed transaction is set forth in the
definitive proxy statement on file with the SEC.
(3)Data were extrapolated from Feldman HA,
Goldstein I, Hatzichristou DG, Krane RJ. Impotence and its Medical and
Psychosocial Correlates: Results of the Massachusetts Male Aging Study,
Journal of Urology. Vol. 151, 54-61, January 1994 and World Population
Projection Program Of United Nations (2002 Revision) with indirect
standardization.
(4)Shabsigh, R. (2002). Back To Great Sex:
Overcome ED and Reclaim Lost Intimacy. New York: Kensington.
(5)Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp.
Data accessed 11.20.03
(6)Lue, Tom F. Erectile Dysfunction. N Engl J
Med 2000; 342: 1802-1813.
(a) Cialis®
is a registered trademark of Lilly ICOS LLC.