SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
July 25, 2002 (July 25, 2002)
ENDO PHARMACEUTICALS HOLDINGS INC.
(Exact name of registrant as specified in its charter)
DELAWARE 39040 13-4022871
(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation)
100 Painters Drive
Chadds Ford, Pennsylvania 19317
(Address of principal executive offices) (Zip Code)
(610) 558-9800
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Item 7. Financial Statements and Exhibits.
(a) Financial Statements of Business Acquired.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Exhibits.
Exhibit Number Description
99.1 Press Release of Endo Pharmaceuticals Holdings Inc.
dated July 25, 2002
Item 9. Regulation FD Disclosure.
On July 25, 2002, the Registrant issued a press release, a copy of
which is filed herewith as Exhibit 99.1 and is incorporated herein by
reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
ENDO PHARMACEUTICALS HOLDINGS INC.
(Registrant)
By: /s/ CAROL A. AMMON
Name: Carol A. Ammon
Title: President & Chief Executive Officer
Dated: July 25, 2002
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press Release of Endo Pharmaceuticals Holdings Inc.
dated July 25, 2002
Exhibit 99.1
[ENDO LOGO]
For Immediate Release CONTACTS:
Bill Newbould
Endo Pharmaceuticals
(610) 558-9800
Jeremy Fielding/Jon Morgan
Kekst & Company
(212) 521-4800
Endo Pharmaceuticals Reports Strong Second Quarter Results
- Continued Growth of Lead Products Drives Performance -
- Company Raises 2002 Guidance -
CHADDS FORD, Pa., July 25, 2002 -- Endo Pharmaceuticals Holdings Inc. (Nasdaq:
ENDP; ENDPW), a market leader in pain management, today reported its financial
results for the second quarter and six months ended June 30, 2002.
Net sales grew by 59% to $107.9 million in the second quarter of 2002 compared
with $67.9 million for the same period in 2001. For the quarter, net income
rose to $22.0 million, or $0.22 per diluted share, in 2002 versus $2.7
million, or $0.03 per diluted share, in the year-ago second quarter. On a pro
forma basis, excluding the amortization of goodwill and workforce-in-place to
reflect new accounting standards adopted on January 1, 2002, net income in the
second quarter of 2001 was $9.6 million, or $0.11 per diluted share.
Consolidated EBITDA for the three months ended June 30, 2002 rose 70% to $45.1
million from $26.6 million in the comparable period a year ago.
"These outstanding top- and bottom-line results continue to be driven by the
strong growth of our core product line, reflecting our leadership position in
pain management," said Carol A. Ammon, chairman and chief executive officer.
She noted that sales of Percocet(R) have continued to accelerate following the
successful introduction of two new strengths in November 2001. Also showing
excellent growth during the quarter were Lidoderm(R), the first FDA-approved
product for the treatment of pain associated with post-herpetic neuralgia, and
Endo's generic extended-release morphine sulfate product. "As a result of this
performance, combined with our continued confidence in the underlying strength
of our business, we are raising our previous guidance for 2002 net sales from
$300 million to $350 million, and for consolidated EBITDA from $100 million to
$125 million. Of course, there can be no assurance of the company achieving
these numbers," Ammon said.
Year-to-Date Results
For the six months, net sales were $174.9 million in 2002, up 63% from $107.2
million in 2001. Net income was $27.4 million, or $0.27 per diluted share,
versus a net loss of $11.5 million, or $0.13 per diluted share, in the first
half of 2001. On a pro forma basis, excluding the amortization of goodwill and
workforce-in-place to reflect new accounting standards adopted on January 1,
2002, the six-month results in 2001 reflect net income of $8.0 million, or
$0.09 per diluted share. Consolidated EBITDA of $60.9 million for the first
half of 2002 was nearly double the $31.2 million reported in the same period
of 2001.
Supplemental Financial Information
The following table presents a reconciliation of operating income as
determined by GAAP to consolidated EBITDA the three months ended June 30, 2002
and June 30, 2001:
(Unaudited)
Three Months Ended
June 30,
2002 2001
---- ----
(in thousands)
GAAP operating income $36,702 $6,659
Depreciation and amortization 691 12,377
Non-cash manufacturing charges 6,384 7,554
Non-recurring manufacturing transfer costs 1,301 -
------- -------
Consolidated EBITDA $45,078 $26,590
======= =======
The following table presents a reconciliation of operating income as
determined by GAAP to consolidated EBITDA the six months ended June 30, 2002
and June 30, 2001:
(Unaudited)
Six Months Ended
June 30,
2002 2001
---- ----
(in thousands)
GAAP operating income (loss) $47,073 $(4,071)
Depreciation and amortization 1,476 24,776
Non-cash manufacturing charges 11,081 10,471
Non-recurring manufacturing transfer costs 1,301 -
------- -------
Consolidated EBITDA $60,931 $31,176
======= =======
Product Review
Percocet(R). Sales of Percocet(R) were $40.6 million for the three months
ended June 30, 2002, a gain of 12% from $36.2 million in the same period of
2001. For the first half, sales were $64.1 million in 2002 versus $56.4
million in 2001, a 14% increase. "Driving this growth was the continued
success of Percocet's(R) most recent formulations, 7.5/325 and 10/325, which
provide effective pain management at a reduced dose of acetaminophen," Ammon
noted.
Lidoderm(R). For the second quarter of 2002, sales of Lidoderm(R) grew to
$25.8 million from $7.0 million in the 2001 second quarter, and rose to $35.8
million for the six months in 2002 versus $10.7 million in the same period a
year ago. "Lidoderm continues to grow at an impressive rate, reflecting broad
market acceptance of the product's clinical utility," said Ammon.
Other branded products. Combined sales of all other branded products were $4.3
million and $9.6 million for the quarter and six months in 2002 compared with
$3.6 million and $8.6 million in the respective periods of 2001.
Generic products. Led by growth in morphine sulfate extended-release tablets
and Endocet(R), sales from generic products rose to $37.2 million in the
second quarter, up 77% from $21.0 million in the year-ago quarter, and
increased to $65.4 million for the first six months, a 107% increase from
$31.6 million in the first half of 2001.
As previously announced, Endo has exercised its option to convert its
specialty sales force to Endo employees from the contract sales organization
Ventiv Health US Sales Inc., effective July 1, 2002. "Based on the success of
Lidoderm(R) and our new strengths of Percocet(R), we've strengthened our
internal sales capabilities, bringing in-house 70 representatives and seven
district managers from the Ventiv sales force," Ammon said. For the remainder
of its sales force, which is composed of 160 pharmaceutical sales
representatives as well as their management, Endo continues to contract with
Ventiv.
Note to Investors
Endo will conduct a conference call with financial analysts to discuss this
news release today at 11:00 a.m. EDT. Investors and other interested parties
may access the conference call by dialing (800) 474-8920 (domestic) or (719)
457-2727 (international). Please dial in 10 minutes prior to the scheduled
start time. A replay of the call will be available from July 25, 2002 at 2:00
p.m. by dialing (888) 203-1112 (domestic) or (719) 457-0820 (international),
passcode 795907, and will run until 12:00 a.m. on August 1, 2002.
A simultaneous webcast of the call for interested investors and others may be
accessed by visiting www.endo.com. In addition, a replay of the webcast will
be available until August 4, 2002. The replay can be accessed by clicking on
"Events" in the Investor Relations section of the company's web site.
About Endo
Endo Pharmaceuticals is a fully integrated specialty pharmaceutical company
with market leadership in pain management products. 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 about the company, including this and past
press releases of Endo Pharmaceuticals Holdings Inc., is available online at
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. 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 obligations 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 the Endo and could cause those results to differ materially from
those expressed in the forward-looking statements contained herein. 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 Registration Statement on Form S-4 filed with
the Securities and Exchange Commission on June 9, 2000, as amended. Readers
should evaluate any statement in light of these important factors.
(Tables Attached)
The following table presents Endo's unaudited net sales for the three months
and six months ended June 30, 2002 and June 30, 2001:
Endo Pharmaceuticals Holdings Inc.
Net Sales (unaudited)
(in thousands)
Three Months Ended Six Months Ended
June 30, June 30,
-------- --------
2002 2001 2002 2001
---- ---- ---- ----
Percocet(R) $40,610 $36,242 $64,078 $56,401
Lidoderm(R) 7,022 35,836 10,665
25,834
Other Brands 4,295 3,589 9,621 8,591
------- ----- -------- -------
Total Brands $70,739 $46,853 $109,535 $75,657
Total Generics $37,163 $21,004 $65,393 $31,582
-------- -------- -------- --------
Total Net Sales $107,902 $67,857 $174,928 $107,239
======== ======== ======== ========
The following table presents Endo's consolidated statements of operations for
the three months and six months ended June 30, 2002 and June 30, 2001:
Endo Pharmaceuticals Holdings Inc.
Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2002 2001 2002 2001
---- ---- ---- ----
NET SALES $107,902 $67,857 $174,928 $107,239
COST OF SALES 27,805 21,032 46,696 33,681
-------- ------- -------- --------
GROSS PROFIT 80,097 46,825 128,232 73,558
COSTS AND EXPENSES:
Selling, general and administrative 27,562 19,453 51,145 35,343
Research and development 15,142 8,336 28,538 17,510
Depreciation and amortization 691 12,377 1,476 24,776
-------- ------- -------- --------
OPERATING INCOME (LOSS) 36,702 6,659 47,073 (4,071)
INTEREST EXPENSE, Net 1,649 2,903 3,271 6,443
-------- ------- -------- --------
INCOME (LOSS) BEFORE INCOME TAX 35,053 3,756 43,802 (10,514)
-------- ------- -------- --------
INCOME TAX 13,052 1,025 16,425 993
-------- ------- -------- --------
NET INCOME (LOSS) $22,001 $2,731 $27,377 $(11,507)
======== ====== ======= =========
NET INCOME (LOSS) PER SHARE:
Basic $.22 $.03 $ .27 $ (.13)
Diluted $.22 $.03 $ .27 $ (.13)
NET INCOME
Pro Forma to Exclude Amortization of Goodwill
and Workforce-in-Place $22,001 $9,554 $27,377 $7,982
======= ====== ======= ======
NET INCOME PER SHARE
Pro Forma to Exclude Amortization of Goodwill and
Workforce-in-Place:
Basic $.22 $.11 $ .27 $ .09
Diluted $.22 $.11 $ .27 $ .09
WEIGHTED AVERAGE SHARES:
Basic 102,064 89,139 102,064 89,139
Diluted 102,271 89,213 102,276 89,139
The following table presents the Endo's unaudited condensed consolidated
balance sheet data at June 30, 2002 and December 31, 2001:
Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Balance Sheet Data (unaudited)
(in thousands)
June 30, December 31,
2002 2001
---- ----
ASSETS
Cash and cash equivalents $151,835 $95,357
Other current assets 182,407 145,568
------------ ------------
Total current assets 334,242 240,925
Property and equipment, net 9,590 9,883
Goodwill 181,079 182,318
Other Intangibles, net 12,125 12,495
Deferred income taxes 17,167 23,420
Restricted cash 150 150
Other assets 1,764 1,804
------------ ------------
TOTAL ASSETS $556,117 $470,995
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current portion of long-term debt $94,707 $91,259
Other current liabilities 145,421 84,407
------------ ------------
Total current liabilities 240,128 175,666
Long-term debt, less current portion - -
Other liabilities 217 207
Total stockholders' equity 315,772 295,122
------------ ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $556,117 $470,995
============ ============
The following table presents condensed consolidated cash flow data for the six
months ended June 30, 2002 and June 30, 2001:
Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Cash Flow Data (unaudited)
(in thousands)
Six Months Ended
June 30,
2002 2001
---- ----
Net cash provided by operating activities $64,031 $39,342
Net cash used in investing activities (827) (2,000)
Net cash used in financing activities (6,726) (29,511)
-------- --------
Net increase in cash and cash equivalents $56,478 $7,831
Cash and cash equivalents, beginning of period $95,357 $59,196
-------- --------
Cash and cash equivalents, end of period $151,835 $67,027
======== ========
Effective January 1, 2002, Endo adopted the new goodwill accounting standards
and will no longer amortize goodwill and workforce-in-place. The pro forma
effect of the adoption of these new accounting standards, including the pro
forma effect on income taxes for the three months ended June 30, 2002 and June
30, 2001, is as follows:
(Unaudited)
Three Months Ended
June 30,
2002 2001
---- ----
(in thousands, except per share
data)
Reported net income $22,001 $2,731
Add back: Goodwill amortization - 10,225
Add back: Amortization of workforce-in-place - 1,487
Less: Pro forma income tax - (4,889)
------- ------
Adjusted net income $22,001 $9,554
======= ======
Basic earnings per share:
Reported net income $.22 $.03
Add back: Goodwill amortization - .11
Add back: Amortization of workforce-in-place - .02
Less: Pro forma income tax - (.05)
------- ------
Adjusted net income $.22 $.11
======= ======
Diluted earnings per share:
Reported net income $.22 $.03
Add back: Goodwill amortization - .11
Add back: Amortization of workforce-in-place - .02
Less: Pro forma income tax - (.05)
------- ------
Adjusted net income $.22 $.11
======= ======
Effective January 1, 2002, Endo adopted the new goodwill accounting standards
and will no longer amortize goodwill and workforce-in-place. The pro forma
effect of the adoption of these new accounting standards, including the pro
forma effect on income taxes for the six months ended June 30, 2002 and June
30, 2001, is as follows:
(Unaudited)
Six Months Ended
June 30,
2002 2001
---- ----
(in thousands, except per share
data)
Reported net income (loss) $27,377 $(11,507)
Add back: Goodwill amortization - 20,450
Add back: Amortization of workforce-in-place - 2,974
Less: Pro forma income tax - (3,935)
------- ------
Adjusted net income $27,377 $7,982
======= ======
Basic earnings (loss) per share:
Reported net income (loss) $.27 $(.13)
Add back: Goodwill amortization - .23
Add back: Amortization of workforce-in-place - .03
Less: Pro forma income tax - (.04)
------- ------
Adjusted net income $.27 $.09
======= ======
Diluted earnings (loss) per share:
Reported net income (loss) $.27 $(.13)
Add back: Goodwill amortization - .23
Add back: Amortization of workforce-in-place - .03
Less: Pro forma income tax - (.04)
------- ------
Adjusted net income $.27 $.09
======= ======
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.
Operating Income (Loss) to Consolidated EBITDA Reconciling Items:
Non-cash manufacturing charges reflect the present value of non-interest
bearing promissory notes issued annually to Bristol-Myers Squibb Pharma
Company ("BMS") (formerly the DuPont Pharmaceuticals Company) over the initial
five-year term of the manufacturing and supply agreement with BMS.
Non-recurring manufacturing transfer costs represent the costs incurred to
transfer certain products from BMS to alternative manufacturers. Endo
anticipates incurring these costs during 2002 and 2003.
- XXX -