BOTHELL, Wash. and INDIANAPOLIS, Jan. 18 /PRNewswire-FirstCall/ --
Lilly ICOS LLC (Lilly ICOS) (NYSE:LLY) (NASDAQ:ICOS) is releasing
its financial results for the fourth quarter and year ended
December 31, 2006. Cialis (tadalafil)(1) Net Sales: (in millions)
Three Months Ended Year Ended December 31, December 31,
------------------ ------------------ 2006 2005 2006 2005 ------
------ ------ ------ Lilly ICOS Territories: United States $106.0
$81.6 $377.3 $272.9 Europe(2) 84.7 65.3 299.1 244.5 Canada and
Mexico 24.0 18.6 78.8 59.3 ------ ------ ------ ------ Total Lilly
ICOS 214.7 165.5 755.2 576.7 Royalty Territories 54.5 45.0 215.8
169.9 ------ ------ ------ ------ Worldwide Total $269.2 $210.5
$971.0 $746.6 ====== ====== ====== ====== In December 2006, Lilly
ICOS submitted a supplemental New Drug Application to the U.S. Food
and Drug Administration for 5 mg and 2.5 mg once-a-day dosing of
Cialis for the treatment of erectile dysfunction (ED). Earlier in
2006, regulatory submissions occurred in Europe and Canada for
Cialis as a once-a- day treatment for ED. Patient enrollment is
ongoing in a Phase 3 clinical study of tadalafil for the treatment
of pulmonary arterial hypertension and a Phase 2b clinical study of
tadalafil for the treatment of benign prostatic hyperplasia. 2006
Fourth Quarter Financial Results For the three months ended
December 31, 2006, Lilly ICOS reported net income of $99.9 million,
compared to $61.4 million for the three months ended December 31,
2005. Net income for the 2006 fourth quarter was consistent with
the guidance provided by ICOS Corporation in its press release on
December 14, 2006. Reported net income of $99.9 million, in the
2006 fourth quarter, includes the impact of an increase in
wholesaler inventories, an adjustment to royalty income for prior
periods and changes in currency exchange rates on non-U.S. revenues
and expenses, which collectively total approximately $3.8 million
and were not considered in the December 14, 2006 guidance. Total
Lilly ICOS revenue for the fourth quarter of 2006 was $226.7
million, compared to $174.5 million for the fourth quarter of 2005.
It is estimated that there was a $2.1 million increase in U.S.
wholesaler inventories at December 31, 2006, compared to September
30, 2006. Lilly ICOS revenue for the fourth quarter of 2006
included $12.0 million in royalties on sales reported by Lilly,
compared to $9.0 million in royalty revenue for the fourth quarter
of 2005. Royalty revenue in the fourth quarter of 2006 includes
$1.1 million related to reconciliations of third party sales for
prior periods. In the U.S., market share of total prescriptions of
Cialis was 27.1% for the three months ended December 2006, an
increase of 0.8 percentage points compared to the three months
ended September 2006(3). Based on total prescriptions, the U.S. ED
market grew 4.1%, for the three months ended December 2006,
compared to the three months ended September 2006. Across Europe,
Canada, and Mexico, Cialis captured 35.6% of aggregate market share
(tablets shipped from wholesalers to pharmacies) for the three
months ended November 2006, an increase of 0.2 percentage points
compared to the three months ended August 2006(4). Compared to the
2006 third quarter, changes in currency exchange rates (primarily
the Euro and British Pound) added approximately $0.8 million to
reported net income in the 2006 fourth quarter. Selling, general
and administrative expenses increased $9.9 million from the fourth
quarter of 2005, to $94.4 million in the fourth quarter of 2006.
The increase was primarily due to increased U.S. consumer marketing
expenses, partially offset by the impact of refinements in the U.S.
sales force configuration. 2006 Full-Year Financial Results For the
year ended December 31, 2006, Lilly ICOS reported net income of
$320.3 million, compared to $37.8 million for the year ended
December 31, 2005, primarily reflecting a $224.4 million increase
in worldwide sales of Cialis and a $96.8 million reduction in
selling, general and administrative costs. Total Lilly ICOS revenue
for 2006 was $800.9 million, compared to $610.7 million for 2005.
Lilly ICOS revenue for 2006 includes $45.7 million in royalties on
sales reported by Lilly, compared to $34.0 million in royalty
revenue for 2005. Royalty revenue for 2006 includes $2.6 million
related to reconciliations of third party sales. The increase in
total revenue reflects the impact of market share gains, market
growth and price increases. Cost of sales totaled $59.7 million in
2006, including royalties payable by Lilly ICOS equal to 5% of its
net product sales. Cost of sales, as a percentage of net product
sales, was 7.9% in 2006, compared to 8.2% in 2005. The percentage
decrease was primarily the result of price increases in 2005 and
2006. Selling, general and administrative expenses were $363.0
million for the year ended December 31, 2006, compared to $459.8
million for the year ended December 31, 2005. The decrease was
primarily due to refinements in the U.S. sales force configuration
and lower consumer marketing expenses. Pending Acquisition of ICOS
Corporation by Eli Lilly and Company On December 18, 2006, ICOS
Corporation (ICOS) announced that it had amended the Agreement and
Plan of Merger with Eli Lilly and Company (Lilly), whereby Lilly
will acquire all of the outstanding stock of ICOS for a purchase
price of $34 per share in cash, which Lilly has indicated is its
best and final offer. A special meeting of the shareholders of ICOS
is to be held on January 25, 2007, to vote on the merger. Closing
of the transaction is expected shortly after the special
shareholders meeting, subject to customary closing conditions
including the favorable vote of a majority of the outstanding
chairs of ICOS. About Lilly ICOS LLC Lilly ICOS LLC, a joint
venture equally owned by ICOS and Lilly, is marketing Cialis in
North America and Europe for the treatment of erectile dysfunction.
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 needs such as benign prostatic hyperplasia, pulmonary
arterial hypertension, cancer, psoriasis and inflammatory diseases.
Eli Lilly and Company, 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, Indiana,
Lilly provides answers - through medicines and information - for
some of the world's most urgent medical needs. F-LLY 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. Such
forward-looking statements are based on current expectations,
estimates and projections about the industry, management beliefs
and certain assumptions made by the managements of ICOS and Lilly.
Investors are cautioned that matters subject to forward-looking
statements involve risks and uncertainties, including economic,
competitive, governmental, technological, legal and other factors
discussed in the two companies' respective filings with the
Securities and Exchange Commission, which may affect the business
and prospects of the two companies and Lilly ICOS. Results and the
timing and outcome of events may differ materially from those
expressed or implied by the forward-looking statements in this
press release. More specifically, there can be no assurance that
Cialis will achieve sustained commercial success or that competing
products will not pre- empt market opportunities that might exist
for the product. The forward-looking statements contained in this
press release represent ICOS' and Lilly's judgments as of the date
of this release. Neither ICOS nor Lilly undertake any obligation to
update any forward-looking statements. Where to Find Additional
Information About the Proposed Acquisition by Eli Lilly and Company
A special meeting of ICOS shareholders will be held on January 25,
2007 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 http://www.sec.gov/, at
ICOS' website at http://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. Lilly ICOS LLC Condensed
Consolidated Statements of Operations (in thousands) (unaudited)
Three Months Ended Twelve Months Ended December 31, December 31,
--------------------- --------------------- 2006 2005 2006 2005
-------- -------- -------- -------- Revenue: Product sales, net
$214,667 $165,501 $755,180 $576,734 Royalties 11,989 8,997 45,727
33,969 -------- -------- -------- -------- Total revenue 226,656
174,498 800,907 610,703 -------- -------- -------- --------
Expenses: Cost of sales 16,904 13,200 59,687 47,264 Selling,
general and administrative 94,353 84,416 363,042 459,827 Research
and development 15,454 15,494 57,863 65,816 -------- --------
-------- -------- Total expenses 126,711 113,110 480,592 572,907
-------- -------- -------- -------- Net income $99,945 $61,388
$320,315 $37,796 ======== ======== ======== ======== Lilly ICOS LLC
SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2006
--------------------------------------------- Q1 Q2 Q3 Q4 TOTAL
---- ---- ---- ---- --------- Revenue: Product sales, net: United
States $82,537 $93,779 $94,946 $106,022 $377,284 Europe 67,586
71,374 75,427 84,645 299,032 Canada and Mexico 17,151 17,508 20,205
24,000 78,864 -------- -------- -------- -------- -------- Total
product sales, net 167,274 182,661 190,578 214,667 755,180
Royalties 11,088 11,642 11,008 11,989 45,727 -------- --------
-------- -------- -------- Total revenue 178,362 194,303 201,586
226,656 800,907 -------- -------- -------- -------- --------
Expenses: Cost of sales 13,382 14,370 15,031 16,904 59,687 Selling,
general and administrative 86,517 90,342 91,830 94,353 363,042
Research and development 13,502 13,820 15,087 15,454 57,863
-------- -------- -------- -------- -------- Total expenses 113,401
118,532 121,948 126,711 480,592 -------- -------- -------- --------
-------- Net income (loss) $64,961 $75,771 $79,638 $99,945 $320,315
======== ======== ======== ======== ======== Lilly ICOS LLC
SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2005
--------------------------------------------- Q1 Q2 Q3 Q4 TOTAL
---- ---- ---- ---- --------- Revenue: Product sales, net: United
States $42,744 $71,118 $77,438 $81,615 $272,915 Europe 56,264
60,925 61,992 65,311 244,492 Canada and Mexico 12,186 13,839 14,727
18,575 59,327 -------- -------- -------- -------- -------- Total
product sales, net 111,194 145,882 154,157 165,501 576,734
Royalties 7,790 9,010 8,172 8,997 33,969 -------- -------- --------
-------- -------- Total revenue 118,984 154,892 162,329 174,498
610,703 -------- -------- -------- -------- -------- Expenses: Cost
of sales 9,752 11,934 12,378 13,200 47,264 Selling, general and
administrative 137,027 126,232 112,152 84,416 459,827 Research and
development 13,874 18,413 18,035 15,494 65,816 --------- --------
-------- -------- -------- Total expenses 160,653 156,579 142,565
113,110 572,907 --------- -------- -------- -------- -------- Net
income (loss) $(41,669) $(1,687) $19,764 $61,388 $37,796 =========
======== ======== ======== ======== (1) Cialis(R) is a registered
trademark of Lilly ICOS LLC. (2) Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom. (3) IMS Health, IMS National
Prescription Audit Plus(TM) (total prescriptions), December 2006.
(4) IMS Health, IMS MIDAS (tablets from wholesalers to pharmacies),
November 2006. DATASOURCE: Lilly ICOS LLC CONTACT: Mark Taylor of
Eli Lilly and Company, +1-317-276-5795; or Lacy Fitzpatrick of ICOS
Corporation, +1-425-415-2207
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