Exhibit 99
Date: October 19, 2006
Lilly ICOS LLC Reports Record Sales for Third Quarter of 2006
- Worldwide Sales of Cialis Exceed $245 Million -
- Net Income was $79.6 Million for 2006 Third Quarter -
- Patient Enrollment Underway in Phase 2b Clinical Study for Symptoms of BPH -
Bothell, WASH. and Indianapolis, IND. - October 19, 2006 - Lilly ICOS LLC (Lilly
ICOS) (NYSE: LLY and Nasdaq: ICOS) is releasing its financial results for the
2006 third quarter, ended September 30. Worldwide sales of Cialis(R)
(tadalafil)(1) totaled $245.6 million in the third quarter of 2006, an increase
of 26% compared to the third quarter of 2005. Net income was $79.6 million for
the 2006 third quarter, compared to $19.8 million in the 2005 third quarter.
Cialis Net Sales:
- -----------------
(in millions)
Three Months Ended Nine Months Ended
September 30, September 30,
--------------------------------- ---------------------------------
2006 2005 2006 2005
----------------- --------------- ----------------- ---------------
Lilly ICOS Territories:
United States $ 94.9 $ 77.5 $ 271.3 $ 191.3
Europe(2) 75.5 62.0 214.4 179.2
Canada and Mexico 20.2 14.7 54.9 40.7
----------------- --------------- ----------------- ---------------
Total Lilly ICOS 190.6 154.2 540.6 411.2
Royalty Territories 55.0 40.9 161.2 124.9
----------------- --------------- ----------------- ---------------
Worldwide Total $ 245.6 $195.1 $ 701.8 $ 536.1
================= =============== ================= ===============
In August 2006, patient enrollment began in a Phase 2b clinical study evaluating
the efficacy and safety of tadalafil in men with symptoms of benign prostatic
hyperplasia (BPH). The double-blind, placebo-controlled Phase 2b clinical study
is designed to enroll more than 1,000 patients, administered one of four doses
of tadalafil or placebo once-a-day for 12 weeks. This trial may serve as a
pivotal study to support regulatory filings seeking approval of tadalafil for
the treatment of symptoms of BPH.
- ---------------------
(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.
1
Financial Results
- -----------------
Lilly ICOS reported net income of $79.6 million for the three months ended
September 30, 2006, compared to $19.8 million for the three months ended
September 30, 2005, reflecting a $50.5 million (26%) increase in worldwide sales
of Cialis and a $20.3 million (18%) reduction in selling, general and
administrative expenses.
Total Lilly ICOS revenue for the third quarter of 2006 was $201.6 million,
compared to $162.3 million for the third quarter of 2005, an increase of 24%.
The increase primarily reflects the impact of market share gains, market growth
and price increases.
The $20.3 million (18%) decrease in selling, general and administrative
expenses, in the third quarter of 2006, compared to the third quarter of 2005,
was primarily due to refinements in the U.S. sales force configuration and lower
consumer marketing expenditures in the third quarter of 2006.
Research and development expenses were $15.1 million in the third quarter of
2006, compared to $18.0 million in the third quarter of 2005. The decrease was
primarily the result of completing, in 2005, a BPH Phase 2 clinical study as
well as other regulatory studies, partially offset by increased costs associated
with the pulmonary arterial hypertension and BPH clinical studies in 2006.
For the nine months ended September 30, 2006, Lilly ICOS reported net income of
$220.4 million, compared to a net loss of $23.6 million for the nine months
ended September 30, 2005. The improvement was primarily due to the $165.7
million (31%) increase in worldwide sales of Cialis and a $106.7 million (28%)
reduction in selling, general and administrative expenses.
About Lilly ICOS LLC
- --------------------
Lilly ICOS LLC, a joint venture equally owned by ICOS Corporation and Eli Lilly
and Company, 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 conditions such as benign prostatic
hyperplasia, hypertension, pulmonary arterial hypertension, cancer 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.
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.
2
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.
--Selected financial data follows--
3
Lilly ICOS LLC
Condensed Consolidated Statements of Operations
(in thousands)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
----------------------------------- ----------------------------------
2006 2005 2006 2005
--------------- ---------------- --------------- ---------------
Revenue:
Product sales, net $ 190,578 $ 154,157 $ 540,513 $ 411,233
Royalties 11,008 8,172 33,738 24,972
--------------- ---------------- --------------- ---------------
Total revenue 201,586 162,329 574,251 436,205
--------------- ---------------- --------------- ---------------
Expenses:
Cost of sales 15,031 12,378 42,783 34,064
Selling, general and administrative 91,830 112,152 268,689 375,411
Research and development 15,087 18,035 42,409 50,322
--------------- ---------------- --------------- ---------------
Total expenses 121,948 142,565 353,881 459,797
--------------- ---------------- --------------- ---------------
Net income (loss) $ 79,638 $ 19,764 $ 220,370 $ (23,592)
=============== ================ =============== ===============
4
Lilly ICOS LLC
SUMMARIZED OPERATING RESULTS
(in thousands)
(unaudited)
2006 2005
------------------------------------ ----------------------------------------------
Q1 Q2 Q3 TOTAL Q1 Q2 Q3 Q4 TOTAL
-------- -------- -------- --------- --------- -------- -------- -------- ---------
Revenue:
Product sales, net:
United States $82,537 $93,779 $94,946 $271,262 $42,744 $71,118 $77,438 $81,615 $272,915
Europe 67,586 71,374 75,427 214,387 56,264 60,925 61,992 65,311 244,492
Canada and Mexico 17,151 17,508 20,205 54,864 12,186 13,839 14,727 18,575 59,327
-------- ----------------- --------- --------- -------- -------- -------- ---------
Total product sales, net 167,274 182,661 190,578 540,513 111,194 145,882 154,157 165,501 576,734
Royalties 11,088 11,642 11,008 33,738 7,790 9,010 8,172 8,997 33,969
-------- -------- -------- --------- --------- -------- -------- -------- ---------
Total revenue 178,362 194,303 201,586 574,251 118,984 154,892 162,329 174,498 610,703
-------- -------- -------- --------- --------- -------- -------- -------- ---------
Expenses:
Cost of sales 13,382 14,370 15,031 42,783 9,752 11,934 12,378 13,200 47,264
Selling, general and
administrative 86,517 90,342 91,830 268,689 137,027 126,232 112,152 84,416 459,827
Research and development 13,502 13,820 15,087 42,409 13,874 18,413 18,035 15,494 65,816
-------- -------- -------- --------- --------- -------- -------- -------- ---------
Total expenses 113,401 118,532 121,948 353,881 160,653 156,579 142,565 113,110 572,907
-------- -------- -------- --------- --------- -------- -------- -------- ---------
Net income (loss) $64,961 $75,771 $79,638 $220,370 $(41,669) $(1,687) $19,764 $61,388 $37,796
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