Endo Pharmaceuticals Reports Third Quarter 2005 Financial Results

Endo Pharmaceuticals
Holdings Inc. (Nasdaq: ENDP), a specialty pharmaceutical company with market
leadership in pain management, today reported financial results for the three
months and nine months ended September 30, 2005.
Net sales for the third quarter were $245.2 million compared with $160.3
million in the third quarter of 2004, an increase of 53%. Net income for the
three months ended September 30, 2005 was $66.6 million compared with $41.4
million in the comparable 2004 period. As detailed in the Supplemental
Financial Information below, adjusted net income for the three months ended
September 30, 2005 was $77.1 million compared with $41.4 million in the same
period in 2004.
Diluted earnings per share for the three months ended September 30, 2005
were $0.50 compared with $0.31 in the comparable 2004 period. As detailed in
the Supplemental Financial Information below, adjusted diluted earnings per
share for the three months ended September 30, 2005 were $0.58 compared with
$0.31 in the same period in 2004.
"Our strong financial performance in the third quarter primarily reflects
the continued strong growth of Lidoderm(R), our topical analgesic patch, and
the successful launch late in the second quarter of all four strengths of our
generic extended-release oxycodone tablets," said Peter A. Lankau, president
and chief executive officer.
"We continue to believe that we will be able to achieve total 2005 net
sales of approximately $800 million to $825 million," said Lankau. "Further,
we reaffirm our previous guidance for Lidoderm(R) net sales, which we continue
to expect to be approximately $390 million to $400 million in 2005. In
addition, we continue to anticipate adjusted diluted earnings per share to be
approximately $1.68 to $1.73. Of course, there can be no assurance of Endo
achieving these results. With the projected growth of Lidoderm(R) as well as
the further progression of our substantial development pipeline including
oxymorphone ER and IR, we believe we are well-positioned for the future."

Year-to-Date Results
For the first nine months of 2005, Endo's net sales were $579.4 million
compared with $457.8 million in the comparable 2004 period, an increase of
27%. Net income for the nine months ended September 30, 2005 was $129.4
million compared with $114.1 million in the comparable 2004 period. As
detailed in the Supplemental Financial Information below, adjusted net income
for the nine months ended September 30, 2005 was $152.4 million compared with
$122.7 million in the same period in 2004.
Diluted earnings per share for the nine months ended September 30, 2005
were $0.97 compared with $0.86 in the comparable 2004 period. As detailed in
the Supplemental Financial Information below, adjusted earnings per share for
the nine months ended September 30, 2005 were $1.14 per diluted share compared
with $0.92 in the comparable 2004 period.
Adjusted diluted earnings per share estimates for the full year 2005
exclude: stock compensation costs and associated taxes related to the Endo
Pharma LLC stock option plans; estimated and actual upfront and milestone
payments to partners, and; the costs associated with the write-off of the
transdermal fentanyl patch inventory and the unamortized portion of the
upfront license fee that Endo paid Noven in February 2004.

Use of Non-GAAP Measures -- Consolidated EBITDA, Adjusted Net Income and
Adjusted Diluted Earnings per Share:
Consolidated EBITDA, Adjusted Net Income and Adjusted Diluted Earnings per
Share are non-GAAP financial measures. These non-GAAP financial measures are
not prepared in accordance with accounting principles generally accepted in
the United States and may be different from non-GAAP financial measures used
by other companies. Endo refers to these non-GAAP financial measures in
making operating decisions because it believes they provide meaningful
supplemental information regarding the company's operational performance. For
instance, Endo believes that these non-GAAP financial measures facilitate its
internal comparisons to its historical operating results and comparisons to
competitors' results. The company includes these non-GAAP financial measures
in its earnings announcements because it believes they are useful to investors
in allowing for greater transparency related to supplemental information used
by Endo in its financial and operational decision-making. In addition, Endo
has historically reported similar non-GAAP financial measures to its investors
and believes that the inclusion of comparative numbers provides consistency in
its financial reporting at this time. Further, Endo believes that these non-
GAAP financial measures may be useful to investors, as it is aware that
certain of its significant stockholders utilize these measures to evaluate its
financial performance. Finally, these measures are considered by the
Compensation Committee of Endo's Board of Directors in assessing the
performance and compensation of substantially all of its employees, including
its executive officers. Investors are encouraged to review the reconciliation
of the non-GAAP financial measures used in this earnings announcement to their
most directly comparable GAAP financial measures as provided with the
financial statements included in this press release and are encouraged to read
the definition of Consolidated EBITDA and the description of the reconciling
items at the end of this press release.

Supplemental Financial Information
A reconciliation of net income as determined by GAAP to adjusted net
income for the three months ended September 30, 2005 and September 30, 2004 is
as follows:


(Unaudited)
Three Months Ended
September 30,
2005 2004
(in thousands,
except per share
data)

GAAP net income $66,553 $41,377
Add: Income tax 40,862 25,349
GAAP income before income tax 107,415 66,726
Add: Upfront and milestone payments to partners 6,500 -
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee 10,515 -
Adjusted income before income tax 124,430 66,726
Pro forma income tax 47,335 25,349
Adjusted net income $77,095 $41,377

Diluted weighted average shares outstanding 133,532 132,460

GAAP diluted earnings per share $0.50 $0.31
Add: Upfront and milestone payments to
partners, net of tax 0.03 -
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee, net of tax 0.05 -
Adjusted diluted earnings per share $0.58 $0.31


A reconciliation of net income as determined by GAAP to adjusted net
income for the nine months ended September 30, 2005 and September 30, 2004 is
as follows:


(Unaudited)
Nine Months Ended
September 30,
2005 2004
(in thousands,
except per share
data)

GAAP net income $129,414 $114,099
Add: Income tax 79,319 69,865
GAAP income before income tax 208,733 183,964
Add: Upfront and milestone payments to partners 26,500 10,000
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee 10,515 -
Add: Termination of development agreement - 3,800
Adjusted income before income tax 245,748 197,764
Pro forma income tax 93,385 75,106
Adjusted net income $152,363 $122,658

Diluted weighted average shares outstanding 133,122 132,688

GAAP diluted earnings per share $0.97 $0.86
Add: Upfront and milestone payments to
partners, net of tax 0.12 0.04
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee, net of tax 0.05 -
Add: Termination of development agreement, net
of tax - 0.02
Adjusted diluted earnings per share $1.14 $0.92


The following table presents a reconciliation of net income as determined
by GAAP to consolidated EBITDA for the three months ended September 30, 2005
and September 30, 2004:


(Unaudited)
Three Months Ended
September 30,
2005 2004
(in thousands)

GAAP net income $66,553 $41,377
Add: Income tax 40,862 25,349
Less: Interest income, net (2,689) (578)
GAAP operating income 104,726 66,148
Add: Depreciation and amortization 4,144 2,985
Add: Upfront and milestone payments to partners 6,500 -
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee 10,515 -
Consolidated EBITDA $125,885 $69,133

The following table presents a reconciliation of net income as determined
by GAAP to consolidated EBITDA for the nine months ended September 30, 2005
and September 30, 2004:

(Unaudited)
Nine Months Ended
September 30,
2005 2004
(in thousands)

GAAP net income $129,414 $114,099
Add: Income tax 79,319 69,865
Less: Interest income, net (6,657) (796)
GAAP operating income 202,076 183,168
Add: Depreciation and amortization 11,438 7,074
Add: Upfront and milestone payments to
partners 26,500 10,000
Add: Write-off of transdermal fentanyl patch
inventory and unamortized portion of the
license fee 10,515 -
Add: Termination of development agreement - 3,800
Consolidated EBITDA $250,529 $204,042


Product Review

Lidoderm(R). For the three months ended September 30, 2005, net sales of
Lidoderm(R) were $124.3 million compared with $83.8 million in the same period
in 2004, a 48% increase. For the first nine months of 2005, net sales of
Lidoderm(R) rose 39% to $288.9 million compared with $207.3 million in the
same period a year ago. Prescription growth for Lidoderm(R) was up 35% and
dispensed unit growth was up 37% in the third quarter of 2005 over the
comparable 2004 period. Prescription growth for Lidoderm(R) was up 39% and
dispensed unit growth was up 41% for the nine months ended September 30, 2005
over the comparable 2004 period. The company estimates that prescription
demand for Lidoderm(R) in the third quarter of 2005 was approximately $115
million.

Percocet(R). Net sales of Percocet(R) were $28.8 million for the three
months ended September 30, 2005 compared with $26.0 million in the same period
in 2004. Net sales of Percocet(R) were $81.0 million for the first nine
months ended September 30, 2005 compared with $70.4 million in the same period
in 2004. The company estimates that prescription demand for Percocet(R) in
the 2005 third quarter was approximately $27 million.

Frova(R). Net sales of Frova(R) were $10.3 million and $25.1 million for
the three and nine months ended September 30, 2005, respectively. As
previously announced, during the first quarter of 2005 the company increased
the size of its sales forces and realigned its sales representatives and their
management to capitalize on the product opportunities for both Lidoderm(R) and
Frova(R).

DepoDur(R). Net sales of DepoDur(R) were $0.7 million and $3.0 million
for the three and nine months ended September 30, 2005, respectively. The
company began promoting DepoDur(R) in early 2005 with its 70-representative
hospital sales force. The launch phase of this product is expected to continue
into 2006.

Other branded products. Combined sales of all other branded products were
$2.7 million for the three months ended September 30, 2005 compared with $2.8
million in the comparable period in 2004. Combined sales of all other branded
products were $8.1 million for the nine months ended September 30, 2005
compared with $10.3 million in the comparable period in 2004.

Oxycodone extended-release. In June 2005, the company began commercial
sale of all four strengths of its extended-release oxycodone tablets, the
generic equivalent of Purdue Pharma's OxyContin(R). Net sales of extended-
release oxycodone tablets were $49.3 million and $78.5 million for the three
and nine months ended September 30, 2005, respectively. The net sales during
the second quarter of 2005 were reflective of typical launch quantity
purchases, and by the end of the third quarter of 2005, customer inventory
levels were at expected operating levels.

The company's launch of this product followed the June 7, 2005 unanimous
affirmance by the U.S. Court of Appeals for the Federal Circuit of the
decision issued in Endo's favor by the U.S. District Court of the Southern
District of New York on January 5, 2004. On June 21, 2005, Purdue filed a
petition with the Federal Circuit seeking rehearing of the case by the Federal
Circuit panel that issued the June 7, 2005 decision or, alternatively, by the
entire court. On July 22, 2005, the Federal Circuit Court of Appeals
requested that Endo submit a response brief as part of its review process of
Purdue's petition for rehearing and rehearing en banc. Endo submitted this
response on August 1, 2005. The company remains confident that the prior
decision of the Federal Circuit Court will remain in effect and intends to
continue to pursue its antitrust claims against Purdue.

Other generic products. For the third quarter, due to increased generic
competition with both Endocet(R) and the company's morphine sulfate extended-
release tablets, net sales from the company's other generic products decreased
to $29.2 million from $42.7 million in 2004. Net sales from the company's
other generic products decreased to $94.8 million for the nine months ended
September 30, 2005 compared with $164.7 million in the same period in 2004.
The company expects this additional competition to continue to adversely
impact its market share and price of both Endocet(R) and its morphine sulfate
extended-release tablets.

Note to Investors
Endo will conduct a conference call with financial analysts to discuss
this news release today at 11:00 a.m. ET. Investors and other interested
parties may access the conference call by dialing (800) 305-2862 (domestic) or
(706) 634-1979 (international). Please dial in 10 minutes prior to the
scheduled start time. A replay of the call will be available from October 20,
2005 at 1:00 p.m. ET by dialing (800) 642-1687 (domestic) or (706) 645-9291
(international), passcode 1465997, and will run until 12:00 a.m. ET on October
27, 2005.
A simultaneous webcast of the call for interested investors and others may
be accessed by visiting http://www.endo.com. In addition, a replay of the webcast
will be available until 12:00 a.m. ET on October 27, 2005. The replay can be
accessed by clicking on "Events" in the Investor Relations section of the
website.

About Endo
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty
pharmaceutical company with market leadership in pain management products.
Through its Endo Pharmaceuticals Inc. subsidiary, the company researches,
develops, produces and markets a broad product offering of both branded and
generic pharmaceuticals, meeting the needs of healthcare professionals and
consumers alike. More information, including this and past press releases of
Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com.

Forward-Looking Statements
This press release contains forward-looking statements, within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, as amended, that are based on management's beliefs and
assumptions, current expectations, estimates and projections. Statements that
are not historical facts, including statements which are preceded by, followed
by, or that include, the words "believes," "anticipates," "plans," "expects"
or similar expressions and statements are forward-looking statements. Endo's
estimated or anticipated future results, product performance or other non-
historical facts are forward-looking and reflect Endo's current perspective on
existing trends and information. Many of the factors that will determine the
Company's future results are beyond the ability of the Company to control or
predict. These statements are subject to risks and uncertainties and,
therefore, actual results may differ materially from those expressed or
implied by these forward-looking statements. The reader should not rely on any
forward-looking statement. The Company undertakes no obligation to update any
forward-looking statements whether as a result of new information, future
events or otherwise. Several important factors, in addition to the specific
factors discussed in connection with these forward-looking statements
individually, could affect the future results of Endo and could cause those
results to differ materially from those expressed in the forward-looking
statements contained in this press release. Important factors that may affect
future results include, but are not limited to: market acceptance of the
Company's products and the impact of competitive products and pricing;
dependence on sole source suppliers; the success of the Company's product
development activities and the timeliness with which regulatory authorizations
and product launches may be achieved; successful compliance with extensive,
costly, complex and evolving governmental regulations and restrictions; the
availability on commercially reasonable terms of raw materials and other third
party manufactured products; exposure to product liability and other lawsuits
and contingencies; dependence on third party suppliers, distributors and
collaboration partners; the ability to timely and cost effectively integrate
acquisitions; uncertainty associated with pre-clinical studies and clinical
trials and regulatory approval; uncertainty of market acceptance of new
products; the difficulty of predicting FDA approvals; risks with respect to
technology and product development; the effect of competing products and
prices; uncertainties regarding intellectual property protection;
uncertainties as to the outcome of litigation; changes in operating results;
impact of competitive products and pricing; product development; changes in
laws and regulations; customer demand; possible future litigation;
availability of future financing and reimbursement policies of government and
private health insurers and others; and other risks and uncertainties detailed
in Endo's filings with the Securities and Exchange Commission, including its
Registration Statement on Form S-3 filed with the SEC on April 30, 2004, as
amended and in Endo's Registration Statement on Form S-3 filed with the SEC on
September 2, 2005, as amended . Readers should evaluate any statement in light
of these important factors.

The following tables present Endo's unaudited net sales for the three
months and nine months ended September 30, 2005 and September 30, 2004:

Endo Pharmaceuticals Holdings Inc.
Net Sales (unaudited)
(in thousands)

Three Months Ended
September 30,
2005 2004

Lidoderm(R) $124,337 $83,758
Percocet(R) 28,771 26,044
Frova(R) 10,278 5,019
DepoDur(R) 740 -
Other Brands 2,673 2,834
Total Brands $166,799 $117,655

Oxycodone ER $49,266 $-
Other Generics 29,176 42,694
Total Generics $78,442 $42,694

Total Net Sales $245,241 $160,349

Endo Pharmaceuticals Holdings Inc.
Net Sales (unaudited)
(in thousands)

Nine Months Ended
September 30,
2005 2004

Lidoderm(R) $288,901 $207,349
Percocet(R) 80,955 70,412
Frova(R) 25,086 5,019
DepoDur(R) 2,996 -
Other Brands 8,142 10,290
Total Brands $406,080 $293,070

Oxycodone ER $78,485 $-
Other Generics 94,810 164,736
Total Generics $173,295 $164,736

Total Net Sales $579,375 $457,806

The following table presents Endo's consolidated statements of operations
for the three months and nine months ended September 30, 2005 and September
30, 2004:

Endo Pharmaceuticals Holdings Inc.
Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)

Three Months Ended Nine Months Ended
September 30, September 30,
2005 2004 2005 2004

NET SALES $245,241 $160,349 $579,375 $457,806
COST OF SALES 61,399 38,203 133,242 99,991
GROSS PROFIT 183,842 122,146 446,133 357,815
COSTS AND EXPENSES:
Selling, general and
administrative 47,309 43,512 156,984 125,271
Research and development 22,148 9,501 70,120 38,502
Depreciation and amortization 4,144 2,985 11,438 7,074
Loss on disposal of other
intangible, including
license termination
fee of $3,000 - - - 3,800

Impairment of other
intangible asset 5,515 - 5,515 -

OPERATING INCOME 104,726 66,148 202,076 183,168
INTEREST INCOME, Net 2,689 578 6,657 796
INCOME BEFORE INCOME TAX 107,415 66,726 208,733 183,964
INCOME TAX 40,862 25,349 79,319 69,865
NET INCOME $66,553 $41,377 $129,414 $114,099

NET INCOME PER SHARE:

Basic $ 0.50 $ 0.31 $ 0.98 $ 0.87
Diluted $ 0.50 $ 0.31 $ 0.97 $ 0.86

WEIGHTED AVERAGE SHARES:

Basic 132,376 131,804 132,075 131,792
Diluted 133,532 132,460 133,122 132,688


The following table presents the Endo's unaudited condensed consolidated
balance sheet data at September 30, 2005 and December 31, 2004:

Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Balance Sheet Data (unaudited)
(in thousands)

September 30, December 31,
2005 2004
ASSETS
Cash and cash equivalents $410,487 $278,034
Accounts receivable, net 258,547 139,039
Inventory 62,920 71,415
Other current assets 102,420 79,089
Total current assets 834,374 567,577
Property and equipment, net 34,322 28,875
Goodwill 181,079 181,079
Other intangibles, net 100,874 117,258
Note receivable 47,960 45,047
Other assets 14,497 7,655
TOTAL ASSETS $1,213,106 $947,491

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $391,499 $273,248
Other liabilities 25,064 18,293

Total stockholders' equity 796,543 655,950

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $1,213,106 $947,491

The following table presents condensed consolidated cash flow data for the
nine months ended September 30, 2005 and September 30, 2004:


Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Cash Flow Data (unaudited)
(in thousands)

Nine Months Ended
September 30,
2005 2004

Net cash provided by operating activities $171,659 $70,596
Net cash used in investing activities (25,111) (106,188)
Net cash used in financing activities (14,095) (9,001)
Net increase (decrease) in cash and cash
equivalents $132,453 $(44,593)

Cash and cash equivalents, beginning of period
inning of period $278,034 $229,573
Cash and cash equivalents, end of period $410,487 $184,980

Net Cash Used in Financing Activities
During the nine months ended September 30, 2005, net cash used in
financing activities includes the $21.4 million payment to Endo Pharma LLC, a
limited liability company that currently holds the majority of Endo common
stock, in which affiliates of Kelso & Company and certain other members of
management have an interest. This payment was made pursuant to the tax-
sharing agreement between the company and Endo Pharma LLC, which requires the
company, under certain circumstances, to pay Endo Pharma LLC the amount of the
tax benefits that are usable by the company as a result of the exercise of
stock options granted pursuant to the Endo Pharma LLC Stock Option Plans,
which stock options are exercisable only into shares of Endo common stock held
by Endo Pharma LLC and, accordingly, do not dilute the ownership of the
company's public stockholders. Additionally, during the fourth quarter of
2005, the company will make a payment of approximately $21 million to Endo
Pharma LLC for the remaining 50% of the 2004 tax benefit.
On October 12, 2005, as part of the sale of 33,350,000 shares of our
common stock, approximately 19.5 million shares underlying stock options
granted under the Endo Pharma LLC stock option plans were exercised at a
market price of $26.04, with a weighted average exercise price of $2.72, and
an assumed tax rate of 38.4%. Assuming the attributable compensation charge
deductions are usable to reduce our taxes in 2005, which will permit us to
apply for a refund of previously paid taxes, we are obligated, under our
amended tax-sharing agreement, to pay to Endo Pharma LLC an additional tax
benefit amount of approximately $175 million. Fifty percent of the estimated
tax benefit amount attributable to the October 12, 2005 offering and any
additional tax benefits attributable to the exercise of stock options granted
under the Endo Pharma LLC stock option plans in 2005 will be due within 15
business days of the date we receive an opinion on our final audited 2005
financial statements from our independent registered public accounting firm
(which we estimate will occur within 60 days of our fiscal year-end of
December 31, 2005) and the remaining tax benefit amount attributable to 2005
is due within 30 business days of the date on which we file our 2005 tax
return with the Internal Revenue Service. Additionally, we anticipate that up
to 2.3 million additional stock options granted under the Endo Pharma LLC
stock option plans will be exercised prior to January 1, 2006 and, therefore,
assuming exercise at a market price of $26.04, with a weighted average
exercise price of $2.72, an assumed tax rate of 38.4% and assuming the
attributable compensation charge deductions are usable to reduce our taxes in
2005, we will be obligated, under our amended tax-sharing agreement, to pay to
Endo Pharma LLC an additional tax benefit amount of approximately $21 million
in 2006. All payments that have been, or will be, made or accrued pursuant to
the tax-sharing agreement have been, or will be, reflected as a reduction of
stockholders' equity in our consolidated financial statements. The exercise of
stock options under the Endo Pharma LLC stock option plans do not result in
the issuance of additional shares in the company and will not dilute the
ownership of our public stockholders. The estimated tax benefit amount
payable to Endo Pharma LLC attributable to Endo Pharma LLC stock options
exercised may increase if certain holders of Endo Pharma LLC stock options
exercise stock options in addition to those noted above.

Definition of Consolidated EBITDA
Endo's amended and restated credit facility defines Consolidated EBITDA as
consolidated net income for the applicable period plus, without duplication
and to the extent deducted from revenues in determining consolidated net
income for that period, the sum of (a) the aggregate amount of consolidated
cash interest expense for the period, (b) the aggregate amount of letter of
credit fees paid during the period, (c) the aggregate amount of income tax
expense for the period, (d) all amounts attributable to depreciation and
amortization for the period, (e) all extraordinary and non-recurring charges
during the period (provided that the amount of charges added to consolidated
net income pursuant to this clause (e) that are incurred in connection with
any transfer of manufacturing operations shall not exceed $10 million during
any fiscal year of Endo or $20 million in the aggregate) and (f) all other
non-cash charges during the period; and minus, without duplication and to the
extent added to revenues in determining consolidated net income for such
period, the sum of (i) all extraordinary gains during the period and (ii) all
other non-cash gains during such period, all as determined on a consolidated
basis with respect to Endo and its subsidiaries in accordance with generally
accepted accounting principles.

Reconciling Items
Upfront and milestone payments to partners represent contractual payments
which will be made to development partners based upon the successful
achievement of certain defined milestones. Termination of development
agreement represents a termination payment paid to Lavipharm Laboratories Inc.
of $3.0 million and the write-off the unamortized portion of the intangible
asset related to the license of the products of $0.8 million. Write-off of
transdermal fentanyl patch inventory of $5.0 million and unamortized portion
of the license fee of $5.5 million represents the costs related to the U.S.
Food & Drug Administration decision that it will not approve Noven's
Abbreviated New Drug Application for its developmental transdermal fentanyl
patch.

CONTACT:
Bill Newbould
(610) 558-9800

Author:  

Email:    

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