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): February 21, 2002
(February 20, 2002)
ENDO PHARMACEUTICALS HOLDINGS INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 39040 13-4022871
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(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation)
100 Painters Drive
Chadds Ford, Pennsylvania 19317
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(Address of principal executive offices) (Zip Code)
(610) 558-9800
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(Registrant's telephone number, including area code)
N/A
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(Former name or former address, if changed since last report)
Item 7. Financial Statements and Exhibits.
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(a) Financial Statements of Business Acquired.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Exhibits.
Exhibit Number Description
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99.1 Press release issued by Endo Pharmaceuticals
Holdings Inc. on February 20, 2002
Item 9. Regulation FD Disclosure.
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On February 20, 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
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Name: Carol A. Ammon
Title: President & Chief Executive Officer
Dated: February 21, 2002
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on February 20, 2002
Exhibit 99.1
Contact: Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
Endo Pharmaceuticals Achieves Strong
2001 Financial Results
-- Results Reflect Strength of Product Line and New Strengths of Percocet(R)--
-- 2001 Results Exceed Previous Guidance, 2002 Guidance Raised --
CHADDS FORD, PA, February 20, 2002 -- Endo Pharmaceuticals
Holdings Inc. (Nasdaq: ENDP; ENDPW), a market leader in pain management,
today reported its financial results for the year and quarter ended
December 31, 2001.
For the year ended December 31, 2001, Endo's net sales grew 28% to
$252.0 million from $197.4 million for the same period in 2000. Operating
loss decreased to $27.9 million from $147.9 million in the comparable 2000
period. Net loss decreased to $36.5 million from $156.8 million in the
comparable 2000 period. Consolidated EBITDA increased by 17% to $79.5
million from $67.7 million over the comparable 2000 period. Full year 2001
included a $23.0 million increase in selling, general and administrative
("SG&A") expense and a $13.0 million increase in research and development
("R&D") expense, primarily supporting new product marketing and new product
development.
Carol A. Ammon, President and Chief Executive Officer of Endo
Pharmaceuticals, said, "We are extremely pleased with our 2001 financial
results. We continue to invest in research and development and sales and
marketing as well as the infrastructure to support our continued growth.
During the fourth quarter of 2001, we successfully launched our new
strengths of Percocet(R) and thus far are very satisfied with their market
acceptance. We also are excited that both Lidoderm(R) and our
extended-release morphine sulfate product continue to perform strongly and
gain market share.
"Moreover, we have improved Endo's financial position. Having
successfully completed a public offering of an additional 12.9 million
shares of common stock in the fourth quarter of 2001, we used the proceeds,
for, among other things, the repayment of the Company's outstanding term
loans. We believe 2002 will be another year of growth for Endo. As a result
of the anticipated continued strength of our product line, we believe that
we are well positioned to achieve net sales in 2002 of approximately $280
million and consolidated EBITDA of $90 million. Of course, there can be no
assurance of Endo achieving these numbers."
In addition, Endo announced that John W. Lyle has resigned as
Chairman and as a Director of the Company in order to be able to more
actively pursue other interests. Mr. Lyle will continue to support Endo's
marketing efforts pursuant to the agreement he entered into with the
Company in connection with the Company's acquisition of Algos
Pharmaceutical Corporation in July 2000. Ms. Ammon stated, "We thank John
for his service on our Board of Directors over the past year and a half,
and we look forward to his continued contributions to our company's
success."
The Company also announced that the Board of Directors had
selected Carol A. Ammon to serve as Chairman of the Board, which will be in
addition to her current role as President and Chief Executive Officer of
the Company.
For the fourth quarter ended December 31, 2001, Endo's net sales
increased to $78.5 million from $77.6 million for the same period in 2000.
As expected, the Company continued to experience generic erosion of its
Percocet(R) product during the fourth quarter of 2001. This erosion was
offset, in part, by the launch of its new strengths of Percocet(R). In
addition, net sales of Lidoderm(R) and other products increased during the
fourth quarter of 2001. Operating income increased 73% to $7.6 million from
$4.4 million. Net income increased to $8.0 million from a net loss of
($3.3) million in the comparable 2000 period. Earnings per share increased
to $.08 per diluted share for the fourth quarter of 2001 compared to a net
loss per diluted share of ($.04) in the comparable 2000 period.
Consolidated EBITDA decreased by 36% to $23.6 million from $37.1 million
over the comparable 2000 period. This decrease in consolidated EBITDA
occurred primarily due to an $8.8 million increase in SG&A expense and a
$3.6 million increase in R&D expense in 2001.
During the fourth quarter of 2000, Endo recorded a $15.3 million
non-cash charge resulting from the vesting of stock options pursuant to the
Endo Pharma LLC stock option plans. Stock options granted pursuant to the
Endo Pharma LLC stock option plans vest if Endo's common stock reaches
certain defined thresholds. These options are exercisable for shares
currently held by Endo Pharma LLC, and their exercise will not dilute the
ownership of other holders of Endo common stock. Excluding this charge,
Endo would have recorded net income of $11.2 million or $.13 per share in
the fourth quarter of 2000.
During the fourth quarter of 2001, Endo determined that the
utilization of its deferred tax benefits was more likely than not based on
its anticipated future taxable income in the foreseeable future.
Accordingly, Endo reversed its valuation reserves that had been recorded
against those deferred tax assets. The reversal of the reserves established
in connection with the acquisition of Algos Pharmaceutical Corporation
(Algos) in July 2000 were recorded as a reduction of goodwill. The reversal
of the reserves recorded subsequent to the Algos acquisition were recorded
as an increase to income tax benefit. In addition, during the fourth
quarter of 2001, the Company extinguished its term loan and recorded this
charge as an extraordinary item.
Year-End Results
Net sales for the year ended December 31, 2001 increased by 28% to
$252.0 million from $197.4 million in the comparable 2000 period. Operating
loss for the year ended December 31, 2001 decreased to $27.9 million from
$147.9 million in the comparable 2000 period. Pro Forma Consolidated EBITDA
(as defined in endnote (1) below) for the year ended December 31, 2001
increased to $79.5 million from $62.1 million in the comparable 2000
period. A reconciliation of operating loss as determined by GAAP to Pro
Forma Consolidated EBITDA is as follows:
(Unaudited)
Year Ended
December 31,
(in thousands)
2001 2000
---- ----
GAAP operating loss $(27,898) $(147,902)
Depreciation and amortization 49,234 27,624
Non-cash manufacturing charges 20,934 18,683
Compensation related to stock options 37,253 15,300
Purchased in-process R&D - 133,200
Non-cash separation benefits - 20,782
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Subtotal: Consolidated EBITDA $79,523 $67,687
Operating loss of Algos - (8,525)
Depreciation and amortization of Algos - 128
Merger and other related costs - 1,583
Cash separation benefits - 1,252
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Pro Forma Consolidated EBITDA $ 79,523 $62,125
======== =======
Fourth Quarter Results
Net sales for the three months ended December 31, 2001 increased
by 1% to $78.5 million from $77.6 million in the comparable 2000 period.
Operating income for the three months ended December 31, 2001 increased to
$7.6 million from $4.4 million in the comparable 2000 period. Consolidated
EBITDA (as defined in endnote (1) below) for the three months ended
December 31, 2001 decreased to $23.6 million from $37.1 million in the
comparable 2000 period. A reconciliation of operating income as determined
by GAAP to consolidated EBITDA is as follows:
(Unaudited)
Three Months Ended
December 31,
(in thousands)
2001 2000
---- ----
GAAP operating income $7,648 $4,420
Depreciation and amortization 12,064 12,583
Non-cash manufacturing charges 3,924 4,762
Non-cash compensation charges - 15,300
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Consolidated EBITDA $23,636 $37,065
======== =======
Endo's results have fluctuated in the past, and may continue to
fluctuate. These fluctuations are primarily due to the timing of new
product launches, purchasing patterns of Endo's customers, market
acceptance of our products and the impact of competitive products and
pricing.
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.
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. Forward-looking statements are not
historical facts and include information regarding the Company's possible
or assumed results of operations. Also, statements or expressions that are
preceded by, followed by, or that include, the words "believes,"
"anticipates," "plans," "expects," "intends," "estimates" or similar
expressions 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.
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, and in Endo's Registration Statement on Form S-3 dated October 17,
2001. Readers should evaluate any statement in light of these important
factors.
The following table presents Endo's consolidated statements of operations
for the three months and years ended December 31, 2001 and December 31,
2000:
Endo Pharmaceuticals Holdings Inc.
Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2001 2000 2001 2000
---- ---- ---- ----
NET SALES $78,472 $77,593 $251,979 $197,429
COST OF SALES 20,588 19,454 74,891 63,041
----------------- ------ -------- --------
GROSS PROFIT 57,884 58,139 177,088 134,388
COSTS AND EXPENSES:
Selling, general and administrative 24,574 15,835 79,505 56,537
Research and development 13,598 10,001 38,994 26,012
Depreciation and amortization 12,064 12,583 49,234 27,624
Compensation related to stock options - 15,300 37,253 15,300
Purchased in-process research and development - - - 133,200
Merger and other related costs - - - 1,583
Separation benefits - - - 22,034
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OPERATING INCOME (LOSS) 7,648 4,420 (27,898) (147,902)
INTEREST EXPENSE, Net 1,833 3,729 10,962 15,119
------------ ------------ ------------ ----------
INCOME (LOSS) BEFORE INCOME TAX
(BENEFIT) AND EXTRAORDINARY ITEM 5,815 691 (38,860) (163,021)
------------ ------------ ------------- ----------
INCOME TAX (BENEFIT) (3,579) 3,997 (3,753) (6,181)
------------ ------------ ------------- ----------
INCOME (LOSS) BEFORE EXTRAORDINARY ITEM 9,394 (3,306) (35,107) (156,840)
------------ ------------ ------------- ---------
EXTRAORDINARY ITEM - Loss on Early
Extinguishment of Debt (1,435) - (1,435) -
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NET INCOME (LOSS) $7,959 $ (3,306) $(36,542) $(156,840)
============ ============ ============ ==========
BASIC NET INCOME (LOSS) PER SHARE:
Income (Loss) Before Extraordinary Item $.09 $(.04) $(.38) $(1.97)
Extraordinary Item $(.01) - $(.02) -
Net Income (Loss) $.08 $(.04) $(.40) $(1.97)
DILUTED NET INCOME (LOSS) PER SHARE:
Income (Loss) Before Extraordinary Item $.09 $(.04) $(.38) $(1.97)
Extraordinary Item $(.01) - $(.02) -
Net Income (Loss) $.08 $(.04) $(.40) $(1.97)
WEIGHTED AVERAGE SHARES:
Basic 98,526 89,139 91,505 79,454
Diluted 98,649 89,139 91,505 79,454
The following table presents Endo's unaudited condensed consolidated
balance sheet data at December 31, 2001 and December 31, 2000:
Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Balance Sheet Data (unaudited)
(in thousands)
December 31,
2001 2000
---- ----
ASSETS
Cash and cash equivalents $95,357 $59,196
Other current assets 145,568 113,858
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Total current assets 240,925 173,054
Property and equipment, net 9,883 5,742
Goodwill and other intangibles, net 194,813 284,560
Deferred income taxes 23,420 736
Restricted cash 150 150
Other assets 1,804 3,598
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TOTAL ASSETS $470,995 $467,840
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current portion of long-term debt $91,259 $36,371
Other current liabilities 84,407 63,924
------ ------
Total current liabilities 175,666 100,295
Long-term debt, less current portion - 162,154
Other liabilities 207 7,218
Total stockholders' equity 295,122 198,173
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $470,995 $467,840
======== ========
The following table presents condensed consolidated cash flow data for the
years ended December 31, 2001 and December 31, 2000:
Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Cash Flow Data (unaudited)
(in thousands)
Year Ended
December 31,
2001 2000
---- ----
Net cash provided by operating activities $80,486 $35,069
Net cash (used in) provided by investing activities (6,546) 18,077
Net cash provided by (used in) financing activities (37,779) (15,978)
-------- --------
Net increase in cash and cash equivalents $36,161 $37,168
Cash and cash equivalents, beginning of period $59,196 $22,028
------- -------
Cash and cash equivalents, end of period $95,357 $59,196
======= =======
The following table presents Endo's unaudited net sales for the
three months and year ended December 31, 2001 and December 31, 2000:
Endo Pharmaceuticals Holdings Inc.
Net Sales (unaudited)
(in thousands)
Three Months Ended Year Ended
December 31, December 31,
2001 2000 2001 2000
---- ---- ---- ----
Percocet(R)
$28,136 $38,115 $100,967 $92,366
Lidoderm(R) 13,945 9,706 40,878 22,539
Other Brands 9,146 14,064 25,824 35,375
-------- ------- -------- --------
Total Brands $51,227 $61,885 $167,669 $150,280
Total Generics $27,245 $15,708 $84,310 $47,149
-------- -------- -------- --------
Total Net Sales $78,472 $77,593 $251,979 $197,429
======== ======= ========= ========
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. This and past press releases
of Endo Pharmaceuticals Holdings Inc. are available at Endo's Web site at
http://www.endo.com.
(1) Definition of Consolidated EBITDA: Endo's 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 and Pro Forma 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.
Compensation related to stock options is the non-cash charge resulting from
the vesting of stock options pursuant to the Endo Pharma LLC stock option
plans. Stock options granted pursuant to the Endo Pharma LLC stock option
plans vest if Endo's common stock reaches certain defined thresholds. These
options are exercisable for shares currently held by Endo Pharma LLC, and
their exercise will not dilute the ownership of other holders of Endo
common stock. Non-cash separation benefits is the non-cash charge resulting
from the acceleration of vesting of stock options held by two former
executives pursuant to two separation and release agreements entered into
by Endo in 2000. The assets acquired and liabilities assumed, results of
operations and cash flows of Algos have been included in Endo's financial
results prospectively for reporting periods beginning July 17, 2000. Pro
forma adjustments for Algos reflect results as if Algos was acquired on
January 1, 2000. Merger and other related costs are fees incurred in the
merger with Algos. Cash separation benefits is the cash charge related to
the severance recorded for two former executives.
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