Eli Lilly 2004 Annual Report Download - page 14

FINANCIALS
12
Diabetes care products, composed primarily of Hu-
mulin, biosynthetic human insulin; Humalog, our insulin
analog; and Actos, an oral agent for the treatment of
type 2 diabetes, had aggregate worldwide revenues of
$2.61 billion in 2004, an increase of 2 percent. Diabetes
care revenues in the U.S. decreased 6 percent, to $1.49
billion. Diabetes care revenues outside the U.S. in-
creased 14 percent, to $1.12 billion. Humulin sales in the
U.S. decreased 19 percent, driven primarily by volume
declines due to competitive pressures. Humulin sales
outside the U.S. increased 7 percent. Humalog sales in
the U.S. increased 3 percent as increased prices offset
slight volume declines. Humalog sales outside the U.S.
increased 16 percent, to $416.2 million. Actos revenues,
the majority of which represent service revenues from a
copromotion agreement in the U.S. with Takeda Phar-
maceuticals North America (Takeda), increased 5 per-
cent in 2004. Actos is manufactured by Takeda Chemical
Industries, Ltd., and sold in the U.S. by Takeda.
Sales of Gemzar, a product approved to fi ght vari-
ous cancers, increased 8 percent in the U.S. largely due
to the May 2004 approval for the treatment of late-stage
metastatic breast cancer. Gemzar sales increased
31 percent outside the U.S., driven by strong volume
growth in a number of cancer indications as well as
favorable foreign exchange rates.
Sales of Evista, a product for the prevention and
treatment of osteoporosis, increased 1 percent in the
U.S. due to continued competitive pressures. Outside
the U.S., Evista maintained a strong growth rate of 32
percent, driven by volume growth in several markets
and the early 2004 launch of the product in Japan.
Strattera, the only nonstimulant medicine approved
for the treatment of attention-defi cit hyperactivity disor-
der in children, adolescents, and adults, was launched
in the U.S. in January 2003 and in the United Kingdom in
July 2004. In 2004, Strattera generated an 80 percent in-
crease over 2003 sales despite a very competitive land-
scape. In December 2004, we added a bolded warning
to the product label, which indicates that the medication
should be discontinued in patients with jaundice (yellowing
of the skin or whites of the eyes) or in the event of labora-
tory evidence of liver injury. We expect the 2005 growth
rate to moderate signifi cantly as a result of the substan-
tial increase in the sales base and anticipated wholesaler
destocking due to our restructured arrangements with our
U.S. wholesalers, which is discussed further in Financial
Expectations for 2005.
Forteo, an osteoporosis treatment for patients at
high risk for a fracture, generated $238.6 million in sales
in 2004, which continues its strong growth trajectory fol-
lowing its U.S. launch in December 2002 and European
launches in late 2003 and during 2004.
Xigris, a treatment for severe sepsis, had 2004 sales
growth of 12 percent in the U.S. compared with 2003,
while sales outside the U.S. increased 56 percent during
the same period.
The erectile dysfunction treatment Cialis was
launched in the U.S. in December 2003 by Lilly and ICOS
Corporation. The $552.3 million of worldwide Cialis sales
in 2004, an increase of 172 percent compared to 2003,
comprises $130.6 million of sales in our territories, which
are reported in our net sales, and $421.7 million of sales
in the joint-venture territories. Within the joint-venture
territories, U.S. sales of Cialis were $206.6 million for
2004. In early 2004, Lilly ICOS began a direct-to-consum-
er advertising campaign in the U.S. Cialis continues
to increase its market share in most major markets in
this extremely competitive category.
Alimta was launched in the U.S. in February 2004 for
the treatment of malignant pleural mesothelioma and in
August for second-line treatment of non-small-cell lung
cancer (NSCLC). In addition, in September 2004, Alimta was
granted marketing authorization by the European Commis-
sion for both the treatment of malignant pleural mesothe-
lioma and as a second-line treatment of non-small-cell lung
cancer. Alimta was launched in several European countries
in the second half of 2004, with additional European market
launches scheduled in 2005. We are encouraged by early
sales results for Alimta, which exceeded our expectations
by generating $142.6 million in 2004.
Cymbalta was launched in the U.S. in late August
2004 for the treatment of major depressive disorder and
in September 2004 for the treatment of diabetic periph-
eral neuropathic pain. Cymbalta has been well accepted,
generating $93.9 million in sales in 2004.
Symbyax, launched in the U.S. in January 2004, com-
bines olanzapine (the active ingredient in Zyprexa) and
fl uoxetine (the active ingredient in Prozac) to treat bipolar
depression. Symbyax is the fi rst FDA-approved medication
for this diffi cult-to-treat condition. Symbyax sales in 2004
did not meet our expectations. Several initiatives are under-
way to reposition the product in the marketplace.
Animal health product sales in the U.S. increased 9
percent, while sales outside the U.S. increased 10 percent,
led by Tylan®, Rumensin®, and Paylean®.
Thirteen Key Products Collectively
Delivered 17 Percent Increase in
Net Sales
($ millions; percentages represent
changes from 2003)
The company’s established key
products—Gemzar, Zyprexa, Evista,
Humalog, and Actos—grew $528 million
(7 percent) and generated $8.2 billion
of total net sales in 2004. In addition,
sales of our newly launched growth
products—Strattera, Forteo, Alimta,
Cymbalta, Symbyax, Cialis (non-joint-
venture territories), Xigris, and Yen-
treve—doubled, generating $1.5 billion
of net sales in 2004. We expect our newer
products to approximate 20 percent of
total sales in 2005. Combined, all our
key products grew 17 percent.
Established Newly Launched
Key Products Growth Products
Gemzar
Zyprexa
Evista
Humalog
Actos
Strattera
Forteo
Alimta
Cymbalta
Symbyax
Cialis
Xigris
Yentreve +$4 NM
+$41 +26%
+$57 +78%
+$70 NM
+$94 NM
+$143 NM
+$173 +265%
+$296 +80%
+$22 +5%
+$80 +8%
+$91 +10%
+$143 +3%
+$193 +19%