UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended December 31, 2004,
or
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 |
Commission File No. 0-18728
INDEVUS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 04-3047911 | |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) | |
| One Ledgemont Center 99 Hayden Avenue Lexington, Massachusetts |
02421-7966 | |
| (Address of principal executive offices) | (Zip Code) | |
Registrants telephone number, including area code: (781) 861-8444
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 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 such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12(b)-2 of the Exchange Act.) Yes x No ¨
Indicate the number of shares outstanding of each of the issuers class of common stock, as of the latest practicable date.
| Class: |
Outstanding at February 8, 2005 | |
| Common Stock $.001 par value | 46,969,811 shares |
INDEX TO FORM 10-Q
| PAGE | ||||
| PART I. FINANCIAL INFORMATION | ||||
| Item 1. |
||||
| Consolidated Balance Sheets as of December 31, 2004 and September 30, 2004 |
3 | |||
| Consolidated Statements of Operations for the Three Months ended December 31, 2004 and 2003 |
4 | |||
| Consolidated Statements of Cash Flows for the Three Months ended December 31, 2004 and 2003 |
5 | |||
| 6 | ||||
| Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
8 | ||
| Item 3. |
14 | |||
| Item 4 |
15 | |||
| PART II. OTHER INFORMATION | ||||
| Item 1 |
15 | |||
| Item 5. |
16 | |||
| Item 6. |
16 | |||
| 17 | ||||
2
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Amounts in thousands except share data)
| December 31, 2004 |
September 30, 2004 |
|||||||
| ASSETS | ||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 106,553 | $ | 127,099 | ||||
| Marketable securities |
24,498 | 26,423 | ||||||
| Accounts receivable |
2,638 | 7,042 | ||||||
| Inventories |
2,883 | 1,160 | ||||||
| Prepaids and other current assets |
3,928 | 3,082 | ||||||
| Total current assets |
140,500 | 164,806 | ||||||
| Marketable securities |
3,041 | 3,486 | ||||||
| Property and equipment, net |
698 | 546 | ||||||
| Insurance claim receivable |
1,258 | 1,258 | ||||||
| Prepaid debt issuance costs |
2,338 | 2,503 | ||||||
| Other assets |
1,205 | 1,239 | ||||||
| Total assets |
$ | 149,040 | $ | 173,838 | ||||
| LIABILITIES | ||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 4,572 | $ | 6,361 | ||||
| Accrued expenses |
13,447 | 13,707 | ||||||
| Accrued interest |
2,075 | 950 | ||||||
| Deferred revenue |
12,500 | 12,500 | ||||||
| Total current liabilities |
32,594 | 33,518 | ||||||
| Convertible Notes |
72,000 | 72,000 | ||||||
| License fees payable |
100 | 100 | ||||||
| Deferred revenue |
128,125 | 131,250 | ||||||
| Minority interest |
8 | 8 | ||||||
| STOCKHOLDERS DEFICIT | ||||||||
| Preferred stock, $.001 par value, 5,000,000 shares authorized; |
||||||||
| Series B, 239,425 shares issued and outstanding (liquidation preference at December 31, 2004 $3,026) |
3,000 | 3,000 | ||||||
| Series C, 5,000 shares issued and outstanding (liquidation preference at December 31, 2004 $502) |
500 | 500 | ||||||
| Common stock, $.001 par value, 80,000,000 shares authorized; 47,825,896 shares issued at December 31 and September 30, 2004 |
48 | 48 | ||||||
| Additional paid-in capital |
308,293 | 309,050 | ||||||
| Accumulated deficit |
(390,052 | ) | (368,903 | ) | ||||
| Accumulated other comprehensive loss |
(200 | ) | (131 | ) | ||||
| Treasury stock, at cost, 870,335 and 1,057,125 shares at December 31 and September 30, 2004, respectively |
(5,376 | ) | (6,602 | ) | ||||
| Total stockholders deficit |
(83,787 | ) | (63,038 | ) | ||||
| Total liabilities and stockholders deficit |
$ | 149,040 | $ | 173,838 | ||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
3
CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended December 31, 2004 and 2003
(Unaudited)
(Amounts in thousands except per share data)
| Three months ended December 31, |
||||||||
| 2004 |
2003 |
|||||||
| Revenues: |
||||||||
| Product revenue |
$ | 3,467 | $ | 785 | ||||
| Contract and license fees |
2,296 | 142 | ||||||
| Total revenues |
5,763 | 927 | ||||||
| Costs and expenses: |
||||||||
| Cost of product revenue |
2,480 | 315 | ||||||
| Research and development |
5,878 | 7,554 | ||||||
| Marketing, general and administrative |
17,481 | 4,016 | ||||||
| Total costs and expenses |
25,839 | 11,885 | ||||||
| Loss from operations |
(20,076 | ) | (10,958 | ) | ||||
| Investment income |
674 | 222 | ||||||
| Interest expense |
(1,292 | ) | (1,292 | ) | ||||
| Minority interest |
| 4 | ||||||
| Loss before income taxes |
(20,694 | ) | (12,024 | ) | ||||
| Provision for income taxes |
(455 | ) | | |||||
| Net loss |
$ | (21,149 | ) | $ | (12,024 | ) | ||
| Net loss per common share, basic and diluted |
$ | (0.44 | ) | $ | (0.25 | ) | ||
| Weighted average common shares outstanding, basic and diluted |
47,826 | 47,211 | ||||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended December 31, 2004 and 2003
(Unaudited)
(Amounts in thousands)
| For the three months ended December 31, |
||||||||
| 2004 |
2003 |
|||||||
| Cash flows from operating activities: |
||||||||
| Net loss |
$ | (21,149 | ) | $ | (12,024 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Depreciation and amortization |
80 | 6 | ||||||
| Amortization of convertible note issuance costs |
165 | 165 | ||||||
| Changes in assets and liabilities: |
||||||||
| Accounts receivable |
4,404 | (53 | ) | |||||
| Inventories |
(1,723 | ) | | |||||
| Prepaid and other assets |
(824 | ) | (614 | ) | ||||
| Accounts payable |
(1,789 | ) | (667 | ) | ||||
| Deferred revenue |
(3,125 | ) | | |||||
| Accrued expenses and other liabilities |
855 | 2,320 | ||||||
| Net cash used in operating activities |
(23,106 | ) | (10,867 | ) | ||||
| Cash flows from investing activities: |
||||||||
| Capital expenditures |
(232 | ) | (5 | ) | ||||
| Purchase of marketable securities |
| (3,210 | ) | |||||
| Proceeds from maturities and sales of marketable securities |
2,314 | 2,692 | ||||||
| Net cash provided by (used in) investing activities |
2,082 | (523 | ) | |||||
| Cash flows from financing activities: |
||||||||
| Net proceeds from issuance of common and treasury stock |
478 | 371 | ||||||
| Net cash provided by financing activities |
478 | 371 | ||||||
| Net change in cash and cash equivalents |
(20,546 | ) | (11,019 | ) | ||||
| Cash and cash equivalents at beginning of period |
127,099 | 57,717 | ||||||
| Cash and cash equivalents at end of period |
$ | 106,553 | $ | 46,698 | ||||
The accompanying notes are an integral part of these unaudited consolidated financial statements.
5
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
A. Basis of Presentation
The consolidated interim financial statements included herein have been prepared by Indevus Pharmaceuticals, Inc. (Indevus or the Company) without audit, pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations and cash flows of the Company. The unaudited consolidated financial statements included herein should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Companys Form 10-K for the fiscal year ended September 30, 2004.
Certain prior year amounts have been reclassified to conform to fiscal 2005 classifications.
Indevus is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of product candidates, including SANCTURA (trospium chloride), approved by the U.S. Food and Drug Administration for the treatment of overactive bladder (OAB), and multiple compounds in clinical development.
B. Inventories
Inventories are stated at the lower of cost or market with cost determined under the first-in, first-out (FIFO) method.
The components of inventory are as follows:
| December 31, 2004 |
September 30, 2004 | |||||
| Raw materials |
$ | 2,148,000 | $ | 488,000 | ||
| Finished goods |
735,000 | 672,000 | ||||
| $ | 2,883,000 | $ | 1,160,000 | |||
Inventories consist solely of SANCTURA. Raw materials consist of tablets of SANCTURA in bulk form purchased from the Companys supplier, Madaus A.G. Finished goods consist of SANCTURA tablets packaged in bottles for resale and blister packages for distribution as samples.
C. Basic and Diluted Loss per Common Share
During the three month period ended December 31, 2004, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) the notes convertible into 10,817,000 shares of Common Stock at a conversion price of $6.656 per share and which are convertible through July 15, 2008 and (ii) options to purchase 1,306,000 shares of Common Stock at prices ranging from $6.68 to $20.13 with expiration dates ranging up to September 28, 2014. Additionally, during the three month period ended December 31, 2004, potentially dilutive securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for the period, were as follows: (i) options to purchase 9,468,000 shares of Common Stock at prices ranging from $1.22 to $6.61 with expiration dates ranging up to August 17, 2014; (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock and (iii) warrants to purchase 10,000 shares of Common Stock with an exercise price of $6.19 and an expiration date of July 17, 2006.
During the three month period ended December 31, 2003, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) the notes convertible into 10,817,000 shares of Common Stock at a conversion price of $6.656 per share and which are convertible through July 15, 2008 (ii) options to purchase 3,206,000 shares of Common Stock at prices ranging from $5.72 to $20.13 with expiration dates ranging up to May 13, 2012 and (iii) warrants to purchase 55,000 shares of Common Stock with exercise prices ranging from $5.00 to $7.13 and with expiration dates ranging up to July 17, 2006. Additionally, during the three month period ended December 31, 2003 securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for the period, were as follows: (i) options to purchase 6,985,000 shares of Common Stock at prices ranging from $1.22 to $5.32 with expiration dates ranging up to June 3, 2013; and (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock.
Certain of the above securities contain anti-dilution provisions which may result in a change in the exercise price or number of shares issuable upon exercise or conversion of such securities.
6
INDEVUS PHARMACEUTICALS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
D. Pro Forma Net Loss Information
The Company applies Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations, in accounting for its employee stock-based compensation plans. The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of FASB Statement No. 123 (SFAS No. 148). Had compensation expense for the Companys employee stock option plans been determined based on the fair value at the grant date for awards under these plans using a Black-Scholes option pricing model consistent with the methodology prescribed under SFAS No. 148, the Companys net loss and net loss per share would have approximated the pro forma amounts indicated below:
| Three months ended December 31, |
||||||||
| 2004 |
2003 |
|||||||
| As reported net loss |
$ | (21,149,000 | ) | $ | (12,024,000 | ) | ||
| Noncash compensation expense included in reported net income, net of tax |
$ | | $ | | ||||
| Compensation expense determined under the fair-value method for all awards, net of tax |
$ | (665,000 | ) | $ | (302,000 | ) | ||
| Pro forma net loss |
$ | (21,814,000 | ) | $ | (12,326,000 | ) | ||
| As reported net loss per common share: |
||||||||
| Basic |
$ | (0.44 | ) | $ | (0.25 | ) | ||
| Diluted |
$ | (0.44 | ) | $ | (0.25 | ) | ||
| Pro forma net loss per common share: |
||||||||
| Basic |
$ | (0.46 | ) | $ | (0.26 | ) | ||
| Diluted |
$ | (0.46 | ) | $ | (0.26 | ) | ||
E. Comprehensive Loss
Comprehensive loss for the three month periods ended December 31, 2004 and 2003, respectively, is as follows:
| Three Months Ended December 31, |
||||||||
| 2004 |
2003 |
|||||||
| Net loss |
$ | (21,149,000 | ) | $ | (12,024,000 | ) | ||
| Change in unrealized net gain or (loss) on investments |
(69,000 | ) | (30,000 | ) | ||||
| Comprehensive loss |
$ | (21,218,000 | ) | $ | (12,054,000 | ) | ||
F. Facilities Lease
In December 2004, the Company entered into a lease agreement for new corporate headquarters in Lexington, MA. This lease for approximately 45,000 square feet provides for an initial term of 66 months, commencing upon occupancy. The aggregate minimum rental commitment is approximately $5,400,000. The Company expects to occupy its new facilities in June 2005, prior to the April 2007 expiration of the lease period of its current facilities. The Company expects to record a charge related to the future nonutilization of its current facilities in the period when the Company ceases to use such facilities.
G. SANCTURA
In April 2004, we entered into a co-promotion and licensing agreement with Odyssey Pharmaceuticals, Inc., a specialty branded subsidiary of PLIVA d.d. (PLIVA) (the PLIVA Agreement) for the U.S. commercialization of SANCTURA (trospium chloride) launched in August 2004. Pursuant to the PLIVA Agreement, on September 27, 2004, the Company made formal notification to PLIVA with respect to the termination of the co-promotion period of the Agreement, thereby converting the Agreement into a royalty-bearing structure (the Conversion). The Conversion became effective on November 29, 2004 as of which date approximately 200 of the Companys primary care sales representatives became PLIVA employees. Under this royalty-bearing structure, the Company receives royalties from PLIVA based on net sales of SANCTURA, and PLIVA is responsible for promotional and advertising costs. Additionally, for the three years commencing November 29, 2004, PLIVA commenced