SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the quarterly period ended September 30, 2002 |
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the transition period from ____________ to __________. |
Commission file number: 39040
ENDO PHARMACEUTICALS HOLDINGS INC.
Delaware | 13-4022871 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification Number) |
Indicate by check ü whether the registrant: (1) has filed all reports required to be filed by Sections 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES þ NO o
The aggregate number of shares of the Registrants common stock outstanding as of November 14, 2002 was 102,064,450.
ENDO PHARMACEUTICALS
HOLDINGS INC.
REPORT ON FORM 10-Q
FOR THE QUARTERLY
PERIOD ENDED SEPTEMBER 30, 2002
TABLE OF CONTENTS
Page | ||||||
PART I. FINANCIAL INFORMATION
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Item 1.
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Financial Statements | |||||
Consolidated Balance Sheets (Unaudited)
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||||||
September 30, 2002 and December 31, 2001
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1 | |||||
Consolidated Statements of Operations (Unaudited)
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||||||
Three Months and Nine Months Ended September 30, 2002 and 2001
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2 | |||||
Consolidated Statements of Cash Flows (Unaudited)
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||||||
Nine Months Ended September 30, 2002 and 2001
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3 | |||||
Notes to Consolidated Financial Statements (Unaudited)
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4 | |||||
Item 2.
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Managements Discussion and Analysis of Financial Condition and Results of Operations | 12 | ||||
Overview
|
12 | |||||
Critical Accounting Policies
|
12 | |||||
Results of Operations
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13 | |||||
Goodwill and Other Intangibles
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13 | |||||
Compensation Related to Stock Options
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14 | |||||
Other Events
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15 | |||||
Net Sales
|
16 | |||||
Three Months Ended September 30, 2002
Compared to the Three Months Ended September 30, 2001
|
17 | |||||
Nine Months Ended September 30, 2002 Compared to the Nine
Months Ended September 30, 2001
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18 | |||||
Liquidity and Capital Resources
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20 | |||||
Item 3.
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Quantitative and Qualitative Disclosures About Market Risk | 21 | ||||
Item 4.
|
Controls and Procedures | 21 |
PART II. OTHER INFORMATION
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||||||
Item 1.
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Legal Proceedings | 22 | ||||
Item 2.
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Changes in Securities and Use of Proceeds | 23 | ||||
Item 3.
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Defaults Upon Senior Securities | 23 | ||||
Item 4.
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Submission of Matters to a Vote of Security Holders | 23 | ||||
Item 5.
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Other Information | 23 | ||||
Item 6.
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Exhibits and Reports on Form 8-K | 24 | ||||
Signatures | 25 | |||||
Certifications | 26 |
Forward Looking Statements
We have made forward-looking statements in this document within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements, including estimates of future net sales and consolidated EBITDA contained in the section titled Managements Discussion and Analysis of Financial Condition and Results of Operations, are subject to risks and uncertainties. Forward-looking statements include the information concerning our possible or assumed results of operations. Also, statements including words such as believes, expects, anticipates, intends, estimates, or similar expressions are forward-looking statements. We have based these forward-looking statements on our current expectations and projections about the growth of our business, our financial performance and the development of our industry. Because these statements reflect our current views concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described in Managements Discussion and Analysis of Financial Condition and Results of Operations, Business and elsewhere in this Report could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this Report. Important factors that could cause our actual results to differ materially from the expectations reflected in the forward-looking statements in this Report include, among others:
We do not undertake any obligation to update our forward-looking statements after the date of this Report for any reason, even if new information becomes available or other events occur in the future.
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands, except share data)
September 30, | December 31, | |||||||
2002 | 2001 | |||||||
ASSETS | ||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$ | 36,545 | $ | 95,357 | ||||
Accounts receivable, net
|
111,203 | 85,329 | ||||||
Inventories
|
33,259 | 27,766 | ||||||
Prepaid expenses
|
4,615 | 5,527 | ||||||
Deferred income taxes
|
42,574 | 26,946 | ||||||
Total current assets
|
228,196 | 240,925 | ||||||
PROPERTY AND EQUIPMENT, Net
|
10,477 | 9,883 | ||||||
GOODWILL
|
181,079 | 182,318 | ||||||
OTHER INTANGIBLES, Net
|
11,940 | 12,495 | ||||||
DEFERRED INCOME TAXES
|
24,678 | 23,420 | ||||||
RESTRICTED CASH
|
150 | |||||||
OTHER ASSETS
|
1,665 | 1,804 | ||||||
TOTAL ASSETS
|
$ | 458,035 | $ | 470,995 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable
|
$ | 46,977 | $ | 30,705 | ||||
Accrued expenses
|
70,276 | 50,176 | ||||||
Income taxes payable
|
2,681 | 3,526 | ||||||
Current portion of long-term debt
|
91,259 | |||||||
Total current liabilities
|
119,934 | 175,666 | ||||||
OTHER LIABILITIES
|
231 | 207 | ||||||
COMMITMENTS AND CONTINGENCIES
|
||||||||
STOCKHOLDERS EQUITY
|
||||||||
Preferred Stock, $.01 par value; 40,000,000 shares
authorized; none issued Common Stock, $.01 par value; 175,000,000 shares authorized;
102,064,450 and 102,063,950 issued and outstanding at September 30, 2002
and December 31, 2001, respectively
|
1,021 | 1,021 | ||||||
Additional paid-in capital
|
552,995 | 519,316 | ||||||
Accumulated deficit
|
(216,146 | ) | (225,215 | ) | ||||
Total Stockholders Equity
|
337,870 | 295,122 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY
|
$ | 458,035 | $ | 470,995 | ||||
See Notes to Consolidated Financial Statements
1
ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except share data)
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2002 | 2001 | 2002 | 2001 | |||||||||||||
NET SALES
|
$ | 110,554 | $ | 66,268 | 285,482 | $ | 173,507 | |||||||||
COST OF SALES
|
24,392 | 20,622 | 71,088 | 54,303 | ||||||||||||
GROSS PROFIT
|
86,162 | 45,646 | 214,394 | 119,204 | ||||||||||||
COSTS AND EXPENSES:
|
||||||||||||||||
Selling, general and administrative
|
28,753 | 19,588 | 79,898 | 54,931 | ||||||||||||
Research and development
|
15,352 | 7,886 | 43,890 | 25,396 | ||||||||||||
Depreciation and amortization
|
692 | 12,394 | 2,168 | 37,170 | ||||||||||||
Compensation related to stock
options - primarily selling, general and administrative
|
40,406 | 37,253 | 40,406 | 37,253 | ||||||||||||
Purchased in-process research and development
|
13,334 | 13,334 | ||||||||||||||
Manufacturing transfer fee
|
9,000 | 9,000 | ||||||||||||||
OPERATING (LOSS) INCOME
|
(21,375 | ) | (31,475 | ) | 25,698 | (35,546 | ) | |||||||||
INTEREST EXPENSE, Net of interest income of $376, $607, $1,024 and
$2,423 respectively
|
1,031 | 2,686 | 4,302 | 9,129 | ||||||||||||
(LOSS) INCOME BEFORE INCOME TAX (BENEFIT)
|
(22,406 | ) | (34,161 | ) | 21,396 | (44,675 | ) | |||||||||
INCOME TAX (BENEFIT)
|
(4,098 | ) | (1,168 | ) | 12,327 | (175 | ) | |||||||||
NET (LOSS) INCOME
|
$ | (18,308 | ) | $ | (32,993 | ) | $ | 9,069 | $ | (44,500 | ) | |||||
NET (LOSS) INCOME PER SHARE:
|
||||||||||||||||
Basic
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | |||||
Diluted
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | |||||
NET (LOSS) INCOME PRO FORMA
TO EXCLUDE AMORTIZATION OF GOODWILL AND WORKFORCE-IN-PLACE:
|
$ | (18,308 | ) | $ | (13,868 | ) | $ | 9,069 | $ | (5,886 | ) | |||||
NET (LOSS) INCOME PER SHARE PRO FORMA TO EXCLUDE AMORTIZATION OF GOODWILL AND
WORKFORCE-IN-PLACE:
|
||||||||||||||||
Basic
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | |||||
Diluted
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | |||||
WEIGHTED AVERAGE SHARES:
|
||||||||||||||||
Basic
|
102,064 | 89,139 | 102,064 | 89,139 | ||||||||||||
Diluted
|
102,064 | 89,139 | 102,245 | 89,139 |
See Notes to Consolidated Financial Statements
2
ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
Nine Months Ended | |||||||
September 30, | |||||||
2002 | 2001 | ||||||
OPERATING ACTIVITIES:
|
|||||||
Net Income (Loss)
|
$ | 9,069 | $ | (44,500 | ) | ||
Adjustments to reconcile net
income (loss) to net cash provided by operating activities:
|
|||||||
Depreciation and amortization
|
2,168 | 37,170 | |||||
Purchased in-process research
and development
|
13,334 | ||||||
Amortization of deferred
financing costs
|
290 | 1,165 | |||||
Accretion of promissory notes
|
4,627 | 3,771 | |||||
Deferred income taxes
|
(14,304 | ) | (1,100 | ) | |||
Compensation related to stock options
|
40,406 | 37,253 | |||||
Changes in assets and
liabilities which provided (used) cash:
|
|||||||
Accounts receivable
|
(25,874 | ) | (1,107 | ) | |||
Inventories
|
(5,493 | ) | 9,489 | ||||
Other assets
|
925 | (2,049 | ) | ||||
Accounts payable
|
16,272 | 5,515 | |||||
Accrued expenses
|
42,639 | 8,473 | |||||
Income taxes payable
|
(845 | ) | (2,364 | ) | |||
Other liabilities
|
16,266 | ||||||
Net cash provided by operating
activities
|
83,214 | 67,982 | |||||
INVESTING ACTIVITIES:
|
|||||||
Purchase of property and equipment
|
(2,221 | ) | (4,928 | ) | |||
Acquisition of BML Pharmaceuticals
|
(14,190 | ) | |||||
Net cash used in investing
activities
|
(16,411 | ) | (4,928 | ) | |||
FINANCING ACTIVITIES:
|
|||||||
Repayments of long-term debt
|
(118,889 | ) | (32,941 | ) | |||
Exercise of Endo Pharmaceuticals
Holdings Inc. stock options
|
4 | ||||||
Repurchase of Class A
Transferable and Class B Non-Transferable Warrants
|
(6,730 | ) | |||||
Net cash used in financing
activities
|
(125,615 | ) | (32,941 | ) | |||
NET (DECREASE) INCREASE IN CASH
AND CASH EQUIVALENTS
|
(58,812 | ) | 30,113 | ||||
CASH AND CASH EQUIVALENTS,
BEGINNING OF PERIOD
|
95,357 | 59,196 | |||||
CASH AND CASH EQUIVALENTS, END
OF PERIOD
|
$ | 36,545 | $ | 89,309 | |||
SUPPLEMENTAL INFORMATION:
|
|||||||
Interest Paid
|
$ | 430 | $ | 6,622 | |||
Income Taxes Paid
|
$ | 27,479 | $ | 2,189 | |||
SCHEDULE OF NON-CASH INVESTING
AND FINANCING ACTIVITIES
|
|||||||
Promissory Note issued under
Manufacturing & Supply Agreement
|
$ | 23,000 | $ | 21,301 | |||
Adjustment to fair value of net
assets acquired in the Algos merger due to lease termination
|
$ | 3,131 |
See Notes to Consolidated Financial Statements.
3
ENDO PHARMACEUTICALS HOLDINGS
INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
FOR THE NINE
MONTHS ENDED SEPTEMBER 30, 2002
1. CONSOLIDATED FINANCIAL STATEMENTS
In the opinion of management, the accompanying condensed consolidated financial statements of Endo Pharmaceuticals Holdings Inc. (the Company or we) and its subsidiaries, which are unaudited, include all normal and recurring adjustments necessary to present fairly the Companys financial position as of September 30, 2002 and the results of operations and cash flows for the periods presented. The accompanying consolidated balance sheet as of December 31, 2001 is derived from the Companys audited financial statements. Certain information and footnote disclosure normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted as promulgated by Accounting Principles Board Opinion No. 28 and Rule 10.01 of Regulation S-X under the Securities Act of 1933. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto as of and for the year ended December 31, 2001 contained in the Companys Annual Report on Form 10-K. Certain reclassifications have been made to the prior periods financial statements to conform with the classifications used in 2002.
2. RECENT ACCOUNTING PRONOUNCEMENTS
In June 1998, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 133, Accounting for Derivative Instruments and Hedging Activities, which was effective for all fiscal years beginning after June 15, 2000. SFAS No. 133, as amended by SFAS No. 137 and SFAS No. 138, establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts and for hedging activities. All derivatives, whether designated in hedging relationships or not, are required to be recorded on the balance sheet at fair value. If the derivative is designated in a fair value hedge, the changes in the fair value of the derivative and the hedged item are recognized in earnings. If the derivative is designated as a cash flow hedge, changes in the fair value of the derivative are recorded in other comprehensive income (OCI) and are recognized in the income statement when the hedged item affects earnings. SFAS No. 133 defines new requirements for designation and documentation of hedging relationships as well as ongoing effectiveness assessments in order to use hedge accounting. A derivative that does not qualify as a hedge is marked to fair value through earnings.
At January 1, 2001, we recorded $228,000 as an accumulated transition adjustment as a reduction to earnings.
In June 2001, the FASB, issued SFAS No. 141, Business Combinations, and SFAS No. 142, Goodwill and Other Intangible Assets. SFAS No. 141 was effective for all business combinations completed after June 30, 2001. SFAS No. 142 is effective for fiscal years beginning after December 15, 2001. SFAS No. 141 requires that all business combinations be accounted for under the purchase method only and that certain acquired intangible assets in a business combination be recognized as assets apart from goodwill. SFAS No. 142 establishes revised reporting requirements for goodwill and other intangible assets. See notes 3 and 9 to the consolidated financial statements.
4
3. GOODWILL AND OTHER INTANGIBLES
Effective January 1, 2002, we adopted the provisions of SFAS No. 142, Goodwill and Other Intangible Assets, and will no longer amortize goodwill and workforce in place.
Our goodwill and other intangible assets consist of the following (in thousands):
September 30, 2002 |
December 31, 2001 |
|||||||
Goodwill
|
$ | 181,079 | $ | 182,318 | ||||
Amortizable Intangibles:
|
||||||||
Licenses
|
$ | 11,000 | $ | 11,000 | ||||
Patents
|
3,200 | 3,200 | ||||||
14,200 | 14,200 | |||||||
Less accumulated amortization
|
(2,260 | ) | (1,705 | ) | ||||
Other Intangibles, net
|
$ | 11,940 | $ | 12,495 | ||||
We have one reportable segment, pharmaceutical products. Goodwill arose as a result of the August 26, 1997 acquisition of certain branded and generic pharmaceutical products, related rights and certain assets of DuPont Pharmaceuticals Company (DuPont, formerly The DuPont Merck Pharmaceutical Company, DuPont Merck Pharma and Endo Laboratories, L.L.C.) and the July 17, 2000 acquisition of Algos Pharmaceutical Corporation (Algos). Although goodwill arose in two separate transactions, the components of our operating segment have been integrated and are managed as one reporting unit. Our components extensively share assets and other resources with the other components of our business. In addition, our components do not maintain discrete financial information. Accordingly, the components of our business have been aggregated into one reporting unit and will be evaluated as such for goodwill impairment. Goodwill will be evaluated for impairment on an annual basis on January 1st of each year unless events or circumstances indicate that an impairment has occurred between annual dates. Goodwill has been evaluated for impairment upon the adoption of SFAS No. 142 and no impairment has been identified.
Effective January 1, 2002, the carrying amount of workforce-in-place was reclassified as goodwill. The cost of license fees is capitalized and is being amortized on a straight-line basis over their estimated useful life of twenty years. The cost of acquired patents is capitalized and is being amortized on a straight-line basis over their estimated useful life of seventeen years.
The pro forma effect of the adoption of SFAS No. 141 and SFAS No. 142 is as follows:
(Unaudited) Three Months Ended September 30, |
(Unaudited) Nine Months Ended September 30, |
|||||||||||||||
2002 | 2001 | 2002 | 2001 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Reported net (loss) income
|
$ | (18,308 | ) | $ | (32,993 | ) | $ | 9,069 | $ | (44,500 | ) | |||||
Add back: Goodwill amortization
|
| 10,225 | | 30,675 | ||||||||||||
Add back: Amortization of workforce-in-place
|
| 1,487 | | 4,461 | ||||||||||||
Add back: Pro forma income tax benefit
|
| 7,413 | | 3,478 | ||||||||||||
Adjusted net (loss) income
|
$ | (18,308 | ) | $ | (13,868 | ) | $ | 9,069 | $ | (5,886 | ) | |||||
Basic earnings (loss) per share:
|
||||||||||||||||
Reported net (loss) income
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | |||||
Add back: Goodwill amortization
|
| .11 | | .34 | ||||||||||||
5 |
(Unaudited) Three Months Ended September 30, |
(Unaudited) Nine Months Ended September 30, |
|||||||||||||||
2002 | 2001 | 2002 | 2001 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Add back: Amortization of workforce-in-place
|
| .02 | | .05 | ||||||||||||
Add back: Pro forma income tax benefit
|
| .08 | | .04 | ||||||||||||
Adjusted net (loss) income
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | |||||
Diluted earnings (loss) per share:
|
||||||||||||||||
Reported net (loss) income
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | |||||
Add back: Goodwill amortization
|
| .11 | | .34 | ||||||||||||
Add back: Amortization of workforce-in-place
|
| .02 | | .05 | ||||||||||||
Add back: Pro forma income tax benefit
|
| .08 | | .04 | ||||||||||||
Adjusted net (loss) income
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | |||||
Estimated amortization of intangibles for the five fiscal years subsequent to December 31, 2001 is as follows (in thousands):
2002 | $ | 741 | |
2003 | 741 | ||
2004 | 741 | ||
2005 | 741 | ||
2006 | 741 |
4. COMPENSATION RELATED TO STOCK OPTIONS
Endo Pharma LLC 1997 Executive and Employee Stock Option Plans
On November 25, 1997, the Company established the 1997 Employee Stock Option Plan and the 1997 Executive Stock Option Plan (collectively, the 1997 Stock Option Plans). Pursuant to the recapitalization of the Company which took place on July 17, 2000 in connection with our acquisition of Algos (the Recapitalization), the 1997 Stock Option Plans were amended and restated. The Endo Pharma LLC Amended and Restated 1997 Employee Stock Option Plan and the Endo Pharma LLC Amended and Restated 1997 Executive Stock Option Plan (collectively, the Endo Pharma LLC 1997 Stock Option Plans) reserve an aggregate of 25,615,339 shares of Common Stock of the Company held by Endo Pharma LLC (an affiliate of Kelso & Company in which certain members of management have an interest) for issuance. Stock options granted under the Endo Pharma LLC 1997 Stock Option Plans expire no later than December 31, 2012 unless an initial public offering of the Company Common Stock held by Endo Pharma LLC occurs, in which case the stock options granted will expire on August 26, 2007. The effect of the Recapitalization has been reflected in the accompanying financial statements. Subsequent to the July 17, 2000 acquisition of Algos, the exercise of stock options pursuant to the Endo Pharma LLC 1997 Stock Option Plans does not result in the issuance of additional shares in the Company.
The Class C stock options vest in four discrete tranches contingent upon (i) the Common Stock of the Company exceeding a defined closing price threshold for ninety consecutive trading days, (ii) the closing price of the Common Stock of the Company on the last trading day of such ninety consecutive trading day period being greater than or equal to 85% of the defined closing price and (iii) the holder being a director, officer or employee of the Company or any of its subsidiaries on such date. The defined closing price thresholds are as follows:
6
MorphiDex® is Approved On or Prior to December 31, 2002 |
MorphiDex® is Not Approved On or Prior to December 31, 2002 |
|||||||||
Option Class |
Common Stock Closing Price Threshold |
Common Stock Closing Price Threshold |
||||||||
C1A and C1B | $ | 6.06 | $ | 4.28 | ||||||
C2 | $ | 9.38 | $ | 6.62 | ||||||
C3 | $ | 14.99 | $ | 10.58 | ||||||
C4 | $ | 24.50 | $ | 17.29 |
If each of these share price targets are achieved resulting in the vesting of each tranche of options, the Company will record non-cash compensation charges related to such vesting. Under performance-based options, the measurement of expense is recorded as a non-cash charge at the time performance is achieved and is calculated as the difference between the market price of the stock and the exercise price of the options. If these charges are recorded by the Company in connection with the above options, they will be significant. They will, however, not result in the issuance of additional shares of Company Common Stock. The aforementioned conditions have been achieved for the Class C1A, Class C1B and Class C2 stock options, and therefore these stock options have vested. Accordingly, a non-cash compensation charge of $15.3 million was recorded in the fourth quarter of 2000 for the vesting of the Class C1A and Class C1B stock options, and a non-cash compensation charge of $37.3 million was recorded in the third quarter of 2001 for the vesting of the Class C2 stock options.
As indicated in the table above, if the U.S. Food and Drug Administration (the FDA) does not approve MorphiDex(®) for any pain indication prior to December 31, 2002, the Common Stock Closing Price Threshold for the Endo Pharma LLC 1997 Stock Option Plans will be adjusted which will result in the vesting of the outstanding Class C3 stock options. This does not result, however, in the issuance of additional shares of Company Common Stock. Under performance-based options, the measurement of expense is recorded as a non-cash charge at the time performance is achieved and is calculated as the difference between the market price of the stock and the exercise price of the options. As previously disclosed, the Company does not believe that MorphiDex(®) will be approved by the FDA for any pain indication prior to December 31, 2002. Accordingly, the Company recorded a non-cash compensation charge of $40.4 million in the third quarter of 2002 for the probable vesting of the Class C3 stock options. Under variable plan accounting, this non-cash compensation charge will be adjusted during the fourth quarter when the actual vesting event occurs based on the then market price of the stock. See note 8 to the consolidated financial statements.
The Class C1A, C1B, C2, C3 and C4 stock options are generally exercisable, if vested, upon the earlier of (i) the occurrence of a sale, disposition or transfer of Common Stock, after which neither Kelso & Company nor Endo Pharma LLC any longer own any shares of Common Stock or (ii) January 1, 2006.
Endo Pharma LLC 2000 Supplemental Executive and Employee Stock Option Plans
Pursuant to the Merger and Recapitalization of the Company on July 17, 2000, the Endo Pharma LLC 2000 Supplemental Employee Stock Option Plan and the Endo Pharma LLC 2000 Supplemental Executive Stock Option Plan (collectively, the Endo Pharma LLC 2000 Supplemental Stock Option Plans) were established. The Endo Pharma LLC 2000 Supplemental Stock Option Plans reserve an aggregate of 10,672,314 shares of Common Stock of the Company held by Endo Pharma LLC for issuance. The Endo Pharma LLC 2000 Supplemental Stock Option Plans are only effective on January 1, 2003 in the event that we have not received the approval from the FDA for MorphiDex(®) for any pain indication prior to December 31, 2002. Stock options granted under the Endo Pharma LLC 2000 Supplemental Stock Option Plans expire no later than December 31, 2012 unless an initial public offering of the Company Common Stock held by Endo Pharma LLC occurs, in which case the stock options granted will expire on August 26, 2007. The exercise of stock options pursuant to the Endo Pharma LLC 2000 Supplemental Stock Option Plans does not result in the issuance of additional shares in the Company; however, the issuance of
7
these stock options and/or attainment of defined common stock price targets may result in additional non-cash compensation charges to the Company. These charges may be substantial. The Endo Pharma LLC 2000 Supplemental Stock Option Plans are not currently effective, therefore no options have been granted. See note 8 to the consolidated financial statements.
Endo Pharmaceuticals Holdings Inc. 2000 Stock Incentive Plan
All the options we have granted pursuant to the Endo Pharmaceuticals Holdings Inc. 2000 Stock Incentive Plan have exercise prices equal to the market price of our stock on the date granted and, under accounting principles generally accepted in the United States, a measurement date had occurred on the date of grant. Consequently, we do not expect to incur a charge upon the vesting or exercise of those options.
5. WARRANTS
Class A Transferable Warrants and Class B Non-Transferable Warrants
The Class A Transferable Warrants and Class B Non-Transferable Warrants are exercisable at an exercise price of $.01 per share into a specified number of shares of Common Stock depending on the timing of the FDAs approval of MorphiDex® for one or more pain indications. If the FDA approves MorphiDex® for any pain indication on or before March 31, 2003, these warrants become exercisable on the fifth business day following the date on which we receive such approval. These warrants will remain exercisable for a period of six months after the exercisability date, at which time they will expire. If the FDA does not approve MorphiDex® by March 31, 2003, each of these warrants expires without any payment therefor. See note 8 to the consolidated financial statements.
If the FDA approves MorphiDex® on or prior to March 31, 2003, then upon exercise of these warrants, each warrant will be exercisable into 0.263158 shares of Common Stock. If the FDA does not approve MorphiDex® before March 31, 2003, each of these warrants becomes void and all rights in respect of these warrants will cease. See note 8 to the consolidated financial statements.
On December 5, 2001, we commenced a tender offer to purchase up to 13,500,000 of our outstanding Class A Transferable Warrants and any and all of our outstanding Class B Non-Transferable Warrants. This tender offer expired at midnight on January 25, 2002. As of December 31, 2001, there were outstanding 17,810,526 of these warrants. We accepted an aggregate of 8,585,262 Class A Transferable Warrants and Class B Non-Transferable Warrants for payment at a purchase price of $0.75 per warrant. We used cash on hand to finance the purchase of the tendered warrants. Following the purchase by us, there are outstanding 9,225,264 of these warrants. See note 8 to the consolidated financial statements.
Pre-Merger Endo Warrants
The warrants issued to Endo Pharma LLC (an affiliate of Kelso & Company in which certain members of management have an interest) in connection with the Merger are exercisable at an exercise price of $.01 per share into a specified number of shares of Common Stock if the FDA does not approve MorphiDex® for any pain indication prior to December 31, 2002. As of September 30, 2002, there were outstanding 71,328,424 of these warrants. If the FDA does not approve MorphiDex® before December 31, 2002, then these warrants become exercisable and upon exercise, each warrant will be exercisable into 0.416667 shares of Common Stock for a total of 29,720,177 shares of Common Stock. See note 8 to the consolidated financial statements.
6. RELATED PARTY TRANSACTIONS
On July 14, 2000, Endo Pharma LLC was formed to ensure that the stock options granted pursuant to the 1997 Employee Stock Option Plan and the 1997 Executive Stock Option Plan (collectively, as amended and restated, the Endo Pharma LLC 1997 Stock Option Plans) diluted only the pre-Merger holders of Endo Common Stock (see note 4 to the consolidated financial statements). Subsequent to the Merger, only currently outstanding shares of Common Stock of the Company held by Endo Pharma LLC will be issued upon the exercise of these stock options.
8
Because Endo Pharma LLC, and not the Company, will provide the shares issued upon the exercise of the options, the Company has entered into a tax sharing agreement with Endo Pharma LLC under which the Company will pay to Endo Pharma LLC the amount of the tax benefits it receives as a result of the exercise of these stock options into shares of Common Stock held by Endo Pharma LLC for the years in which these tax benefits arise. As of September 30, 2002, approximately 1.1 million of these stock options have been exercised into shares of Common Stock held by Endo Pharma LLC by former employees. These stock option exercises may permit the Company to deduct for income tax purposes compensation of approximately $8 million, which may result in a tax benefit amount of approximately $3 million. Under the terms of the tax sharing agreement discussed above, the Company must pay any such tax benefit amounts to Endo Pharma LLC only upon the occurrence of a liquidity event, which is generally defined as (a) a sale of greater than 20% on a fully diluted basis of the common equity of the Company (either through a primary offering by the Company or a secondary sale by Endo Pharma LLC or a combination of both), (b) a change in control of the Company or (c) a sale of all or substantially all of the assets of the Company. In accordance with the tax sharing agreement, no payments have been made or accrued.
7. COMMITMENTS AND CONTINGENCIES
We have entered into employment agreements with certain members of management.
We have entered into certain collaboration agreements with third parties for the development of pain management products. These agreements require us to share in the development costs of such products and grant marketing rights to us for such products. If any of our third party partners are unable to fund their portion of the particular collaboration project with us, this may adversely affect our results of operations and cash flows in the foreseeable future.
As described in note 9 to the consolidated financial statements, upon FDA approval of BMLs lead pipeline product, ImmunolTM, we will pay the former shareholders of BML a $32 million payment and an earn-out based on a percentage of net sales of certain products in BMLs pipeline.
As described in note 10 to the consolidated financial statements, we entered into a license agreement (License Agreement) with DURECT Corporation (DURECT) to develop and commercialize DURECTs CHRONOGESICTM (sufentanil) Pain Therapy System for the U.S. and Canada. Once CHRONOGESICs clinical trials have restarted or beginning on June 30, 2004 (whichever is earlier), Endo will be obligated to fund 50% of the CHRONOGESICs ongoing development costs. Endo will also reimburse DURECT for a portion of its prior development costs upon the achievement of certain milestones. Milestone payments made by Endo under the License Agreement could total up to $52.0 million. In addition, the License Agreement also contains terms and conditions customary for this type of arrangement, including representations, warranties, indemnities and termination rights. With respect to termination rights, the License Agreement permits Endo to terminate its continued participation under a number of circumstances, one of which could require Endo to pay DURECT $10.0 million.
We are, and may in the future be, subject to various claims or legal proceedings arising out of the normal course of business with respect to commercial matters, including product liabilities, patent infringement matters, governmental regulation and other actions. We cannot predict the timing or outcome of these claims or proceedings. Currently, the Company is not involved in any claim and/or legal proceeding with respect to which the amount of ultimate liability will, in the opinion of management, materially affect our financial position, results of operations or liquidity.
8. OTHER EVENTS
On June 24, 2002, we announced the results from the first of our three Phase III clinical trials for our development product, MorphiDex®. No statistically significant difference in average daily morphine dose was observed in the morphine sulfate:dextromethorphan group compared to the morphine sulfate group. In addition, we observed no statistically significant difference in the percentage change from baseline in daily morphine dose averaged by week from the commencement of the double-blind study period to the completion of the double-blind study period.
9
On October 28, 2002, we announced the results from the second of our three Phase III clinical trials for our development product, MorphiDex®. No statistically significant difference in analgesia was observed in the MorphiDex® group compared to the morphine sulfate alone group. In addition, the study did not meet its secondary endpoint, a reduction in analgesic tolerance for patients administered MorphiDex®.
While we
expect to be able to announce the results of the third of these clinical trials
in the fourth quarter of this year, the Company believes that the data that has
been generated to date would suggest that we will not have enough evidence to support
the filing of an amendment to the MorphiDex® New Drug Application. Accordingly,
it is not likely MorphiDex® will receive FDA approval prior to December 31, 2002.
As a result:
| As described in note 5 to the consolidated financial statements in this Report, the warrants held by Endo Pharma LLC (an affiliate of Kelso & Company in which certain members of management have an interest) will become exercisable on December 31, 2002 into 29,720,177 shares of Company Common Stock, thereby increasing Endo Pharma LLCs ownership of the Company from approximately 68.5% to approximately 75.6%; | |
| As described in note 4 to the consolidated financial statements in this Report, during the 2002 third quarter, we recorded a non-cash compensation charge of $40.4 million for the probable vesting of the outstanding Class C3 stock options granted under the Endo Pharma LLC 1997 Stock Option Plans. Under variable plan accounting, this non-cash compensation charge will be adjusted during the fourth quarter when the actual vesting event occurs based on the then market price of the stock. Neither the vesting nor the exercise of these stock options will result, however, in the issuance of additional shares of Company Common Stock because these stock options are exercisable only into shares of Company Common Stock that are held by Endo Pharma LLC. Accordingly, these stock options will not dilute the public shareholders; | |
| In addition, as described in note 4 to the consolidated financial statements in this Report, the Endo Pharma LLC 2000 Supplemental Stock Option Plans will become effective on January 1, 2003, resulting in the issuance of approximately 10.7 million stock options to certain employees and members of management on such date, approximately 9.2 million of which will be vested upon their issuance resulting in a significant non-cash compensation charge to the Company. These stock options will not result, however, in the issuance of additional shares of Company Common Stock because these stock options are exercisable only into shares of Company Common Stock that are held by Endo Pharma LLC. Accordingly, these stock options will not dilute the public shareholders. The weighted average exercise price of these options is $2.42 per share; and | |
| Finally, if MorphiDex® is not approved prior to March 31, 2003, the Class A Transferable Warrants and Class B Non-Transferable Warrants will expire and have no economic value. |
9. BML ACQUISITION
On July 29, 2002, our wholly owned subsidiary, Endo Pharmaceuticals Inc., acquired BML Pharmaceuticals, Inc. (BML), a privately held company, for an up-front payment of $14 million. In addition, upon FDA approval of BMLs lead pipeline product, Immunol TM, Endo Pharmaceuticals Inc. will pay the former shareholders of BML a $32 million payment and an earn-out based on a percentage of net sales of certain products in BMLs pipeline. BML will operate as a wholly owned subsidiary of Endo Pharmaceuticals Inc. We have accounted for the acquisition using the purchase method of accounting. In accordance with the purchase method of accounting, the purchase price is allocated to BMLs assets and liabilities based on their respective fair values on the date of the acquisition. The acquisition included an on-going project to research and develop a new pharmaceutical product. Based on preliminary estimates, the allocation of the fair value of the assets acquired and liabilities assumed included an allocation to purchased in-process research and development (IPRD) of $13.3 million which was immediately expensed in the consolidated statement of operations on the acquisition date. The Company expects to finalize the purchase price allocation in the fourth quarter of 2002, which may result in an adjustment to the preliminary allocation. The assets acquired and liabilities assumed, results of operations and cash flows of BML have been
10
included in the Companys financial statements and Managements Discussion and Analysis of Financial Conditions and Results of Operations prospectively for reporting periods beginning July 29, 2002.
10. CHRONOGESICTM LICENSE AGREEMENT
On November 8, 2002, our wholly owned subsidiary, Endo Pharmaceuticals Inc., entered into a Development, Commercialization and Supply License Agreement (License Agreement) with DURECT Corporation (DURECT). Under the terms of the agreement we have agreed to collaborate on the development and commercialization of DURECTs CHRONOGESICTM (sufentanil) Pain Therapy System for the U.S. and Canada. Under the terms of the agreement, we will have no obligation to fund any of the development costs until the clinical trials are restarted (which are currently anticipated to begin in the second half of 2003). In the event that the clinical trials have not restarted by December 31, 2003, then during the six-month period from January 1, 2004 until the earlier of (a) the recommencement of the clinical trials and (b) June 30, 2004, we will be responsible for 25% of the development costs actually incurred each month, up to an aggregate of $3.0 million of development costs for such period.
Once the CHRONOGESICs clinical trials have restarted or beginning on June 30, 2004 (whichever is earlier), Endo will be obligated to fund 50% of the CHRONOGESICs ongoing development costs. Endo will also reimburse DURECT for a portion of its prior development costs upon the achievement of certain milestones. Milestone payments made by Endo under the License Agreement could total up to $52.0 million.
In addition, under the License Agreement, DURECT licensed to Endo the exclusive promotional rights to the Product in the U.S. and Canada. Endo will be responsible for marketing, sales and distribution, including providing specialty sales representatives dedicated to supplying technical and training support. DURECT will be responsible for the manufacture of the Product. Endo and DURECT will share profits equally, based on projected financial performance of the Product.
Further, the License Agreement also contains terms and conditions customary for this type of arrangement, including representations, warranties, indemnities and termination rights. With respect to termination rights, the License Agreement permits Endo to terminate its continued participation under a number of circumstances, one of which could require Endo to pay DURECT $10.0 million.
Finally, in connection with the License Agreement, Endo has purchased approximately 1.5 million newly issued common shares of DURECT for approximately $5.0 million, representing approximately 3% of DURECTs outstanding common stock.
11
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Except for the historical information contained in this Report, this Report, including the following discussion, contains forward-looking statements that involve risks and uncertainties.
Overview
We, through our wholly owned subsidiary, Endo Pharmaceuticals Inc., are engaged in the research, development, sales and marketing of branded and generic prescription pharmaceuticals used primarily for the treatment and management of pain. Branded products comprised approximately 76%, 67% and 62% of net sales for the years ended December 31, 2000, 2001 and the nine months ended September 30, 2002, respectively. On August 26, 1997, an affiliate of Kelso & Company and the then members of management entered into an asset purchase agreement with the then DuPont Merck Pharmaceutical Company to acquire certain branded and generic pharmaceutical products and exclusive worldwide rights to a number of new chemical entities in the DuPont research and development pipeline from DuPont Merck through the newly-formed Endo Pharmaceuticals Inc.
On July 17, 2000, we completed our merger with Algos Pharmaceutical Corporation (Algos). In the merger, we issued to the former Algos stockholders, in the aggregate, 17,810,526 shares of our common stock and 17,810,526 warrants to purchase in the aggregate up to 20,575,507 additional shares of our common stock in certain circumstances as more fully described under notes 5 and 8 to the consolidated financial statements in this Report. In the merger, we also issued to our pre-merger stockholders, in the aggregate, 71,328,424 warrants to purchase in the aggregate up to 29,720,177 additional shares of common stock in certain other circumstances as more fully described under notes 5 and 8 to the consolidated financial statements in this Report.
The stock of Endo Pharmaceuticals Inc. is our only asset, and we have no other operations or business.
In May 2001, we entered into a long-term manufacturing and development agreement with Novartis Consumer Health, Inc., whereby Novartis has agreed to manufacture certain of our commercial products and products in development. We have incurred and expect to continue to incur significant costs associated with the preparation of Novartis manufacturing operations under this agreement. These costs primarily relate to the preparation of test batches of drug product for FDA approval and our own quality assessment and administrative costs relating to the shifting of existing production to Novartis.
Our quarterly 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 our customers, market acceptance of our products and the impact of competitive products and pricing.
Critical Accounting Policies
To understand our financial statements, it is important to understand our accounting policies. The preparation of our financial statements in conformity with accounting principles generally accepted in the United States (generally accepted accounting principles) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Some of these judgments can be subjective and complex, and, consequently, actual results may differ from these estimates. For any given individual estimate or assumption made by us, there may also be other estimates or assumptions that are reasonable. We believe, however, that given current facts and circumstances, it is unlikely that applying any such other reasonable judgment would cause a material adverse effect on our consolidated results of operations, financial position or cash flows for the periods represented in this Report.
Our most critical accounting policies include the determination of sales deductions for estimated chargebacks, rebates, sales incentives and allowances, royalties and returns and losses, the utilization of deferred tax assets and the assessment of impairment of goodwill and other intangible assets. Note 2 to our consolidated financial statements contained in our Annual Report on Form 10-K describes our significant accounting policies.
12
Results of Operations
Goodwill and Other Intangibles
Effective January 1, 2002, we adopted the provisions of SFAS No. 142, Goodwill and Other Intangible Assets and will no longer amortize goodwill and workforce in place.
Goodwill represents a significant portion of our assets and stockholders equity. As of September 30, 2002, goodwill comprised approximately 40% of our total assets and 54% of our stockholders equity. We assess the potential impairment of goodwill by comparing the fair value of goodwill to its carrying value for our one reporting unit. An impairment loss would be recognized when the estimated fair value is less than its carrying amount. As a result of the significance of goodwill, our results of operations and financial position in a future period could be negatively impacted should an impairment of goodwill occur.
We have one reportable segment, pharmaceutical products. Goodwill arose as a result of the August 26, 1997 acquisition of certain branded and generic pharmaceutical products, related rights and certain assets of DuPont Pharmaceuticals Company (DuPont Pharmaceuticals, formerly The DuPont Merck Pharmaceutical Company, DuPont Merck Pharma and Endo Laboratories, L.L.C.) and the July 17, 2000 acquisition of Algos. Although goodwill arose in two separate transactions, the components of our operating segment have been integrated and are managed as one reporting unit. Our components extensively share assets and other resources with the other components of our business and have similar economic characteristics. In addition, our components do not maintain discrete financial information. Accordingly, the components of our business have been aggregated into one reporting unit and will be evaluated as such for goodwill impairment. Goodwill will be evaluated for impairment on an annual basis on January 1st of each year unless events or circumstances indicate that an impairment has occurred between annual dates. Goodwill has been evaluated for impairment upon the adoption of SFAS No. 142 on January 1, 2002 and, based on the fair value of our reporting unit, no impairment has been identified.
Our goodwill and other intangible assets consist of the following (in thousands):
September 30,2002 | December 31, 2001 | ||||||
Goodwill
|
$ | 181,079 | $ | 182,318 | |||
Amortizable Intangibles:
|
|||||||
Licenses
|
$ | 11,000 | $ | 11,000 | |||
Patents
|
3,200 | 3,200 | |||||
14,200 | 14,200 | ||||||
Less accumulated amortization
|
(2,260 | ) | (1,705 | ) | |||
Other Intangibles, net
|
$ | 11,940 | $ | 12,495 | |||
Effective January 1, 2002, we reclassified the carrying amount of workforce-in-place as goodwill. The cost of license fees is capitalized and is being amortized on a straight-line basis over their estimated useful life of twenty years. The cost of acquired patents is capitalized and is being amortized on a straight-line basis over their estimated useful life of seventeen years.
13
The pro forma effect of the adoption of SFAS No. 141 and SFAS No. 142 is as follows:
(Unaudited) Three Months Ended September 30, |
(Unaudited) Nine Months Ended September 30, |
||||||||||||||
2002 | 2001 | 2002 | 2001 | ||||||||||||
(in thousands, except per share data) | |||||||||||||||
Reported net (loss) income
|
$ | (18,308 | ) | $ | (32,993 | ) | $ | 9,069 | $ | (44,500 | ) | ||||
Add back: Goodwill amortization
|
| 10,225 | | 30,675 | |||||||||||
Add back: Amortization of workforce-in-place
|
| 1,487 | | 4,461 | |||||||||||
Add back: Pro forma income tax benefit
|
| 7,413 | | 3,478 | |||||||||||
Adjusted net (loss) income
|
$ | (18,308 | ) | $ | (13,868 | ) | $ | 9,069 | $ | (5,886 | ) | ||||
Basic earnings (loss) per share:
|
|||||||||||||||
Reported net (loss) income
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | ||||
Add back: Goodwill amortization
|
| .11 | | .34 | |||||||||||
Add back: Amortization of workforce-in-place
|
| .02 | | .05 | |||||||||||
Add back: Pro forma income tax benefit
|
| .08 | | .04 | |||||||||||
Adjusted net (loss) income
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | ||||
Diluted earnings (loss) per share:
|
|||||||||||||||
Reported net (loss) income
|
$ | (.18 | ) | $ | (.37 | ) | $ | .09 | $ | (.50 | ) | ||||
Add back: Goodwill amortization
|
| .11 | | .34 | |||||||||||
Add back: Amortization of workforce-in-place
|
| .02 | | .05 | |||||||||||
Add back: Pro forma income tax
|
| .08 | | .04 | |||||||||||
Adjusted net (loss) income
|
$ | (.18 | ) | $ | (.16 | ) | $ | .09 | $ | (.07 | ) | ||||
Estimated amortization of intangibles for the five fiscal years subsequent to December 31, 2001 is as follows (in thousands):
2002 | $741 |
2003 | 741 |
2004 | 741 |
2005 | 741 |
2006 | 741 |
Compensation Related to Stock Options
During our fourth quarter ended December 31, 2000, we incurred a non-cash charge of $15.3 million, and during our third quarter ended September 30, 2001, we recorded a non-cash charge of $37.3 million, in each case for stock-based compensation relating to the vesting of options that were issued under the Endo Pharma LLC stock option plans. In addition, during our third quarter ended September 30, 2002, we recorded a non-cash compensation charge of $40.4 million for the probable vesting of the Class C3 stock options. Under variable plan accounting, this non-cash compensation charge will be adjusted during the fourth quarter of 2002 when the vesting event actually occurs based on the then market price of the stock. Under these plans, tranches of options vest when we attain certain stock price targets. As each tranche vests, we incur a non-cash charge representing the difference between the market price of the shares underlying the options and the exercise price of such options. We may in the future incur additional charges in relation to the Endo Pharma LLC options as a result of the attainment of other common stock price targets. These charges may be substantial. These options are exercisable into shares of common stock that are presently held by Endo Pharma LLC. As a result, the exercise of these options will not result in the issuance of additional shares of common stock.
14
In connection with the Algos merger and our related recapitalization on July 17, 2000, the Endo Pharma LLC 2000 Supplemental Employee Stock Option Plan and the Endo Pharma LLC 2000 Supplemental Executive Stock Option Plan (collectively, the Endo Pharma LLC 2000 Supplemental Stock Option Plans) were established. The Endo Pharma LLC 2000 Supplemental Stock Option Plans reserve an aggregate of 10,672,314 shares of our common stock that is held by Endo Pharma LLC for issuance. The Endo Pharma LLC 2000 Supplemental Stock Option Plans are only effective on January 1, 2003 in the event that we have not received the approval from the FDA of MorphiDex® for the treatment of pain by December 31, 2002. The exercise of stock options pursuant to the Endo Pharma LLC 2000 Supplemental Stock Option Plans does not result in the issuance of additional shares in the Company, however, the issuance of these stock options and/or attainment of defined common stock price targets may result in additional non-cash compensation charges to the Company. These charges may be substantial. The Endo Pharma LLC 2000 Supplemental Stock Option Plans are not currently effective, therefore no options have been granted.
All the options we have granted pursuant to the Endo Pharmaceuticals Holdings Inc. 2000 Stock Incentive Plan have exercise prices equal to the market price of our stock on the date granted and, under accounting principles generally accepted in the United States, a measurement date had occurred on the date of grant. Consequently, we do not expect to incur a charge upon the vesting or exercise of those options.
Other Events
On June 24, 2002, we announced the results from the first of our three Phase III clinical trials for our development product, MorphiDex®. No statistically significant difference in average daily morphine dose was observed in the morphine sulfate:dextromethorphan group compared to the morphine sulfate group. In addition, we observed no statistically significant difference in the percentage change from baseline in daily morphine dose averaged by week from the commencement of the double-blind study period to the completion of the double-blind study period.
On October 28, 2002, we announced the results from the second of our three Phase III clinical trials for our development product, MorphiDex®. No statistically significant difference in analgesia was observed in the MorphiDex® group compared to the morphine sulfate alone group. In addition, the study did not meet its secondary endpoint, a reduction in analgesic tolerance for patients administered MorphiDex®.
While we expect to be able to announce the results of the third of these clinical trials in the fourth quarter of this year, the Company believes that the data that has been generated to date would suggest that we will not have enough evidence to support the filing of an amendment to the MorphiDex® New Drug Application. Accordingly, it is not likely MorphiDex® will receive FDA approval prior to December 31, 2002. As a result:
| As described under note 5 to the consolidated financial statements in this Report, the warrants held by Endo Pharma LLC (an affiliate of Kelso & Company in which certain members of management have an interest) will become exercisable on December 31, 2002 into 29,720,177 shares of Company common stock, thereby increasing Endo Pharma LLCs ownership of the Company from approximately 68.5% to approximately 75.6%; |
| As described under note 4 to the consolidated financial statements in this Report, during the 2002 third quarter, we recorded a non-cash compensation charge of $40.4 million for the probable vesting of the outstanding Class C3 stock options granted under the Endo Pharma LLC 1997 Stock Option Plans. Under variable plan accounting, this non-cash compensation charge will be adjusted during the fourth quarter when the actual vesting event occurs based on the then market price of the stock. Neither the vesting nor the exercise of these stock options will result, however, in the issuance of additional shares of Company common stock because these stock options are exercisable only into shares of Company common stock that are held by Endo Pharma LLC. Accordingly, these stock options will not dilute the public shareholders; |
15
| In addition, as described under note 4 to the consolidated financial statements in this Report, the Endo Pharma LLC 2000 Supplemental Stock Option Plans will become effective on January 1, 2003, resulting in the issuance of approximately 10.7 million stock options to certain employees and members of management on such date, approximately 9.2 million of which will be vested upon their issuance resulting in a significant non-cash compensation charge to the Company. These stock options will not result, however, in the issuance of additional shares of Company common stock because these stock options are exercisable only into shares of Company common stock that are held by Endo Pharma LLC. Accordingly, these stock options will not dilute the public shareholders. The weighted average exercise price of these options is $2.42 per share; and |
| Finally, if MorphiDex® is not approved prior to March 31, 2003, the Class A Transferable Warrants and Class B Non-Transferable Warrants will expire and have no economic value. |
Net Sales
Our net sales consist of revenues from sales of our pharmaceutical products, less estimates for certain chargebacks, rebates, sales incentives and allowances, royalties and the cost of returns and losses. We estimate the accrual for sales deductions based on historical data, estimated future trends and other competitive factors. Net sales are recognized when products are shipped.
The following table presents our unaudited net sales by product category for the three months and nine months ended September 30, 2002 and 2001.
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||
2002 | 2001 | 2002 | 2001 | ||||||||
(in thousands, unaudited) | |||||||||||
Percocet®
|
$ | 36,585 | $ | 16,430 | $ | 100,663 | $ | 72,831 | |||
Lidoderm®
|
24,080 | 16,268 | 59,916 | 26,993 | |||||||
Other brands
|
6,048 | 8,087 | 15,669 | 16,678 | |||||||
Total brands
|
$ | 66,713 | $ | 40,785 | $ | 176,248 | $ | 116,442 | |||
Total generics
|
$ | 43,841 | $ | 25,483 | $ | 109,234 | $ | 57,065 | |||
Total net sales
|
$ | 110,554 | $ | 66,268 | $ | 285,482 | $ | 173,507 | |||
The following table presents our unaudited net sales of select products as a percentage of total net sales for the three months and nine months ended September 30, 2002 and 2001.
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
2002 | 2001 | 2002 | 2001 | |||||||||
(unaudited) | ||||||||||||
Percocet®
|
33 | % | 25 | % | 35 | % | 42 | % | ||||
Lidoderm®
|
22 | % | 25 | % | 21 | % | 16 | % | ||||
Other brands
|
5 | % | 12 | % | 6 | % | 9 | % | ||||
Total brands
|
60 | % | 62 | % | 62 | % | 67 | % | ||||
Total generics
|
40 | % | 38 | % | 38 | % | 33 | % | ||||
Total net sales
|
100 | % | 100 | % | 100 | % | 100 | % | ||||
16
17
difference between the market price of the shares of common stock underlying the options and the exercise price of such options. The Company may in the future incur additional charges in relation to the Endo Pharma LLC options. These charges may be substantial. These options are exercisable into shares of common stock that are presently held by Endo Pharma LLC. As a result, the exercise of these options will not result in the issuance of additional shares of common stock and will not dilute the public stockholders of Endo.
Nine Months Ended September 30, 2002 Compared to the Nine Months Ended September 30, 2001
18
due to the existing fixed cost nature of our manufacturing relationship with Bristol-Myers Squibb Pharma Company (formerly DuPont Pharmaceuticals), currently our most significant contract manufacturing relationship. If we achieve our forecast for revenue and product mix, we expect the increase in gross profits and gross profit margins to continue.
19
20
21
22
well as those that we may develop in the future. We, however, cannot predict the timing or outcome of any such litigation, or whether any such litigation will be brought against us.
23
Dates | Items |
July 25, 2002 | Items 7 & 9 |
July 31, 2002 | Items 7 & 9 |
August 1, 2002 | Items 5 & 7 |
August 23, 2002 | Items 7 & 9 |
August 28, 2002 | Items 5 & 7 |
September 17, 2002 | Items 7 & 9 |
24
SIGNATURES
ENDO PHARMACEUTICALS HOLDINGS INC. | |
(Registrant) | |
/S/ CAROL A. AMMON
|
|
Name: Carol A. Ammon | |
Title: Chairman and Chief Executive Officer | |
/S/ JEFFREY R. BLACK |
|
Name: Jeffrey R. Black | |
Title:
Senior Vice President and Chief Financial Officer
|
|
Date: November 14, 2002
25
CERTIFICATIONS
I, Carol A. Ammon, as Chairman and Chief Executive Officer of the Company, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Endo Pharmaceuticals Holdings Inc. |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a. | Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b. | Evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c. | Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; | |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent function): | |
a. | All significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and | |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. | |
Date: November 14, 2002 | /S/ CAROL A. AMMON Carol A. Ammon Chairman & Chief Executive Officer |
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CERTIFICATIONS
I, Jeffrey R. Black, as Chief Financial Officer of the Company, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Endo Pharmaceuticals Holdings Inc. |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a. | Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b. | Evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c. | Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; | |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent function): |
a. | All significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and | |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
Date: November 14, 2002 | /S/ JEFFREY R. BLACK Jeffrey R. Black Chief Financial Officer |
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Exhibit Index
Exhibit | |||
No. | Title | ||
2.1 | Amended and Restated Agreement and Plan of Merger, dated as of March 3, 2000 (the Merger Agreement), by and among Endo Pharmaceuticals Holdings Inc. (Endo), Endo Inc. and Algos Pharmaceutical Corporation (Algos) (incorporated herein by reference to Exhibit 2.1 of the Registration Statement on Form S-4 of the Registrant (Registration No. 333-39040) (the Registration Statement), filed with the Securities and Exchange Commission (the Commission) on June 9, 2000) | ||
2.2 | Amendment, dated as of April 17, 2000, to the Merger Agreement, by and between Endo, Endo Inc. and Algos (incorporated herein by reference to Exhibit 2.2 of the Registration Statement filed with the Commission on June 9, 2000) | ||
2.3 | Asset Purchase Agreement, dated as of August 27, 1997, by and between Endo Pharmaceuticals Inc. (Endo Pharmaceuticals) and The DuPont Merck Pharmaceutical Company (DuPont Merck Pharmaceutical) (incorporated here in by reference to Exhibit 2.3 of the Registration Statement filed with the Commission on June 9, 2000) | ||
3.1 | Amended and Restated Certificate of Incorporation of Endo (incorporated herein by reference to Exhibit 3.1 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
3.2 | Amended and Restated By-laws of Endo (incorporated herein by reference to Exhibit 3.2 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
4.1 | Amended and Restated Executive Stockholders Agreement, dated as of July 14, 2000, by and among Endo, Endo Pharma LLC (Endo LLC), Kelso Investment Associates V, L.P. (KIA V), Kelso Equity Partners V, L.P. (KEP V) and the Management Stockholders (as defined therein) (incorporated herein by reference to Exhibit 4.1 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
4.2 | Amended and Restated Employee Stockholders Agreement, dated as of July 14, 2000, by and among Endo, Endo LLC, KIA V, KEPV and the Employee Stockholders (as defined therein) (incorporated herein by reference to Exhibit 4.2 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
4.3 | Form of Stock Certificate of Endo Common Stock (incorporated herein by reference to Exhibit 4.3 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
4.4 | Registration Rights Agreement, dated as of July 17, 2000, by and between Endo and Endo LLC (incorporated herein by reference to Exhibit 4.4 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
10.1 | Endo Warrant Agreement, dated as of July 17, 2000, by and |
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Exhibit | |||
No. | Title | ||
between Endo and United States Trust Company of New York(incorporated herein by reference to Exhibit 10.1 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | |||
10.2 | Algos Warrant Agreement, dated as of July 17, 2000, by and between Endo and United States Trust Company of New York(incorporated herein by reference to Exhibit 10.2 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
10.3 | Form of Series A Warrant to Purchase Shares of Common Stock and Warrants of Endo (incorporated herein by reference to Exhibit 10.3 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.4 | Letter Agreement, dated as of November 26, 1999, by and among Algos, Endo, KIA V and KEP V (incorporated herein by reference to Exhibit 10.4 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.5 | Tax Sharing Agreement, dated as of July 17, 2000, by and among Endo, Endo Inc. and Endo LLC (incorporated herein byreference to Exhibit 10.5 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 15, 2000) | ||
10.6 | [Intentionally Omitted.] | ||
10.7 | Amended and Restated Credit Agreement, dated as of December 21, 2001, by and between Endo, Endo Pharmaceuticals, the Lenders Party Thereto and JPMorgan Chase Bank (incorporated by reference to Exhibit 10.7 of the Annual Report on Form 10-K for the Year Ended December 31, 2001 filed with the Commission on March 29, 2002) | ||
10.8 | [Intentionally Omitted.] | ||
10.9 | [Intentionally Omitted.] | ||
10.10 | Sole and Exclusive License Agreement, dated as of November 23, 1998, by and between Endo Pharmaceuticals and Hind Health Care, Inc. (incorporated herein by reference to Exhibit 10.10 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.11 | Analgesic License Agreement, dated as of October 27, 1997, by and among Endo Pharmaceuticals, Endo Laboratories, LLC and DuPont Merck Pharmaceutical (incorporated herein by reference to Exhibit 10.11 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.12 | Anti-Epileptic License Agreement, dated as of October 27, 1997, by and among Endo Pharmaceuticals, Endo Laboratories, LLC and DuPont Merck Pharmaceutical (incorporated herein by reference to Exhibit 10.12 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.13 | [Intentionally Omitted.] | ||
10.14 | Supply and Manufacturing Agreement, dated as of November 23, 1998, by and between Endo Pharmaceuticals and Teikoku Seiyaku Co., Ltd (incorporated herein by reference to Exhibit 10.14 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.15 | Supply Agreement, dated as of July 1, 1998, by and between Endo Pharmaceuticals and Mallinckrodt Inc. (Mallinckrodt) (incorporated herein by reference to Exhibit 10.15 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.16 | Supply Agreement for Bulk Narcotics Raw Materials, dated as of July 1, 1998, by and between Endo Pharmaceuticals and |
29
Exhibit | |||
No. | Title | ||
Mallinckrodt (incorporated herein by reference to Exhibit 10.16 of the Registration Statement filed with the Commission on June 9, 2000) | |||
10.17 | Manufacture and Supply Agreement, dated as of August 26, 1997, by and among Endo Pharmaceuticals, DuPont Merck Pharmaceutical and DuPont Merck Pharma (n/k/a Bristol-Myers Squibb Pharma Company) (incorporated herein by reference to Exhibit 10.17 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.18 | Amended and Restated Strategic Alliance Agreement, dated as of April 2, 2002, by and between Endo Pharmaceuticals and Penwest Pharmaceuticals Co. (incorporated herein by reference to Exhibit 10.18 of the Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2002 filed with the Commission on May 14, 2002) | ||
10.19 | Agreement, dated as of February 1, 2000, by and between Endo Pharmaceuticals and UPS Supply Chain Management, Inc.(f/k/a/ Livingston Healthcare Services Inc.) (incorporated herein by reference to Exhibit 10.19 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.20 | Medical Affairs Support Services Agreement, dated as of June 1, 1999, by and between Endo Pharmaceuticals and Kunitz andAssociates, Inc. (incorporated herein by reference to Exhibit 10.20 of the Registration Statement filed with the Commission on June 9, 2000) | ||
*10.21 | Endo Pharmaceuticals Holdings Inc. 2000 Stock Incentive Plan(incorporated herein by reference to Exhibit 10.21 of the Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2000 filed with the Commission on November 13, 2000) | ||
*10.22 | Endo LLC Amended and Restated 1997 Employee Stock Option Plan (incorporated herein by reference to Exhibit 10.22 of the Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2000 filed with the Commission on November 13, 2000) | ||
*10.23 | Endo LLC Amended and Restated 1997 Executive Stock Option Plan (incorporated herein by reference to Exhibit 10.23 of the Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2000 filed with the Commission on November 13, 2000) | ||
*10.24 | Endo LLC 2000 Amended and Restated Supplemental Employee Stock Option Plan (incorporated herein by reference toExhibit 10.24 of the Quarterly Report on Form 10-Q for theQuarter Ended September 30, 2000 filed with the Commission on November 13, 2000) | ||
*10.25 | Endo LLC 2000 Amended and Restated Supplemental Executive Stock Option Plan (incorporated herein by reference to Exhibit 10.25 of the Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2000 filed with the Commission on November 13, 2000) | ||
*10.26 | Employment Agreement, dated as of July 17, 2000, by and between Endo and John W. Lyle (incorporated herein by reference to Exhibit 10.26 of the Form 10-Q for the Quarter ended June 30, 2000 filed with the Commission on August 14, 2000) | ||
*10.27 | Amended and Restated Employment Agreement, dated as of September 1, 2001, by and between Endo Pharmaceuticals and Carol A. Ammon (incorporated herein by reference to Exhibit 10.27 of the Current Report on Form 8-K dated August 31, 2001) |
30
Exhibit | |||
No. | Title | ||
*10.28 | Amended and Restated Employment Agreement, dated as of September 1, 2001, by and between Endo Pharmaceuticals and Jeffrey R. Black (incorporated herein by reference to Exhibit 10.28 of the Current Report on Form 8-K dated August 31, 2001) | ||
*10.29 | Amended and Restated Employment Agreement, dated as of September 1, 2001, by and between Endo Pharmaceuticals and David Allen Harvey Lee, MD, Ph.D. (incorporated herein by reference to Exhibit 10.29 of the Current Report on Form 8-K dated August 31, 2001) | ||
*10.30 | Amended and Restated Employment Agreement, dated as September 1, 2001, by and between Endo Pharmaceuticals and Mariann T. MacDonald (incorporated herein by reference to Exhibit 10.30 of the Current Report on Form 8-K dated August 31, 2001) | ||
10.31 | Separation and Release Agreement, dated as of March 22, 2000, by and between Endo Pharmaceuticals, Endo and Osagie O. Imasogie (incorporated herein by reference to Exhibit10.31 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.32 | Separation and Release Agreement, dated as of April 20, 2000, by and between Endo Pharmaceuticals, Endo and Louis J. Vollmer (incorporated herein by reference to Exhibit 10.32 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.33 | Office Lease, dated as of August 26, 1997, by and between Endo Pharmaceuticals and Northstar Development Company (incorporated herein by reference to Exhibit 10.33 of the Registration Statement filed with the Commission on June 9, 2000) | ||
10.34 | Lease Agreement, dated as of May 5, 2000, by and between Endo Pharmaceuticals and Painters Crossing One Associates, L.P. (incorporated herein by reference to Exhibit 10.34 of the Registration Statement filed with the Commission on June 9, 2000) | ||
*10.35 | Amended and Restated Employment Agreement, dated as of September 1, 2001, by and between Endo and Caroline B. Manogue (formerly Berry) (incorporated herein by reference to Exhibit 10.35 of the Current Report on Form 8-K dated August 31, 2001) | ||
*10.36 | Amended and Restated Employment Agreement, dated as of September 1, 2001, by and between Endo and Peter A. Lankau (incorporated herein by reference to Exhibit 10.36 of the Current Report on Form 8-K dated August 31, 2001) | ||
10.37 | License Agreement, dated as of August 16, 1993, by and between Endo Pharmaceuticals (as successor in interest to Algos Pharmaceutical Corporation) and The Medical College of Virginia (incorporated herein by reference to Exhibit 10.4.1 of the registration statement on Form S-1 of Algos Pharmaceutical Corporation declared effective on September 25, 1996) | ||
10.38 | [Intentionally Omitted.] | ||
10.39 | Master Development and Toll Manufacturing Agreement, dated as of May 3, 2001, by and between Novartis Consumer Health, Inc. and Endo Pharmaceuticals (incorporated herein by reference to Exhibit 10.39 of the Form 10-Q for the Quarter Ended June 30, 2001 filed with the Commission on August 14, 2001) |
31
Exhibit | |||
No. | Title | ||
10.40 | [Intentionally Omitted.] | ||
10.41 | Service Agreement, dated as of February 1, 2001, by and between Endo Pharmaceuticals and Ventiv Health U.S. Sales Inc. (incorporated herein by reference to Exhibit 10.41 of the Current Report on Form 8-K dated August 31, 2001) | ||
10.42 | Development, Commercialization and Supply License Agreement, dated as of November 8, 2002, by and between DURECT Corporation and Endo Pharmaceuticals Inc. (incorporated herein by reference to Exhibit 10.42 of the Current Report on Form 8-K dated November 14, 2002) | ||
11 | Statement Regarding Computation of per Share Earnings | ||
99.1 | Certificate of the Chairman and Chief Executive Officer of Endo pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ||
99.2 | Certificate of the Chief Financial Officer of Endo pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
32