UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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, 2003 | ||
| OR | ||
| [ ] | 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: 0-20772
QUESTCOR PHARMACEUTICALS, INC.
| CALIFORNIA | 33-0476164 | |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700
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 prior that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [x] No [ ]
Indicate by check mark whether Registrant is an accelerated filer (as defined in Rule 12B-2 of the Act). Yes [ ] No [x]
At November 6, 2003 there were 44,379,058 shares of the Registrants common stock, no par value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
| Page | ||||||
| PART I. FINANCIAL INFORMATION | 3 | |||||
| Item 1 | Financial Statements and Notes (Unaudited) | 3 | ||||
| Condensed Consolidated Balance SheetsSeptember 30, 2003 and December 31, 2002 | 3 | |||||
| Condensed Consolidated Statements of Operationsfor the three and nine months ended September 30, 2003 and 2002 | 4 | |||||
| Condensed Consolidated Statements of Cash Flowsfor the nine months ended September 30, 2003 and 2002 | 5 | |||||
| Notes to Condensed Consolidated Financial Statements | 6 | |||||
| Independent Accountants Review Report | 14 | |||||
| Item 2 | Managements Discussion and Analysis of Financial Condition and Results of Operations | 15 | ||||
| Item 3 | Quantitative and Qualitative Disclosures about Market Risk | 22 | ||||
| Item 4 | Controls and Procedures | 22 | ||||
| PART II. OTHER INFORMATION | 22 | |||||
| Item 1 | Legal Proceedings | 22 | ||||
| Item 2 | Changes in Securities and Use of Proceeds | 22 | ||||
| Item 3 | Defaults Upon Senior Securities | 23 | ||||
| Item 4 | Submission of Matters to a Vote of Security Holders | 23 | ||||
| Item 5 | Other Information | 23 | ||||
| Item 6 | Exhibits and Reports on Form 8-K | 23 | ||||
| Signatures | 24 | |||||
2
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARES)
| September 30, | December 31, | |||||||||||
| 2003 | 2002 | |||||||||||
| (Unaudited) | (Note 1) | |||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ | 2,284 | $ | 6,156 | ||||||||
Short-term investments |
2,537 | 1,350 | ||||||||||
Accounts receivable, net of allowances of
$75 at September 30, 2003 and $49 at December 31, 2002 |
2,144 | 1,590 | ||||||||||
Inventories, net |
1,087 | 391 | ||||||||||
Prepaid expenses and other current assets |
589 | 979 | ||||||||||
Total current assets |
8,641 | 10,466 | ||||||||||
Property and equipment, net |
657 | 585 | ||||||||||
Purchased technology, net |
13,994 | 382 | ||||||||||
Goodwill and other indefinite lived intangible assets |
479 | 479 | ||||||||||
Deposits and other assets |
832 | 854 | ||||||||||
Total assets |
$ | 24,603 | $ | 12,766 | ||||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ | 1,025 | $ | 1,230 | ||||||||
Accrued compensation |
519 | 794 | ||||||||||
Other accrued liabilities |
1,058 | 1,205 | ||||||||||
Payable relating to product acquisition |
2,183 | | ||||||||||
Short-term debt and current portion of long-term debt |
153 | 218 | ||||||||||
Current portion of capital lease obligations |
| 1 | ||||||||||
Total current liabilities |
4,938 | 3,448 | ||||||||||
Convertible debentures, (face amount of $4,000), net
of deemed discount of $721 at September 30, 2003 and
$1,092 at December 31, 2002 |
3,279 | 2,908 | ||||||||||
Other non-current liabilities |
928 | 833 | ||||||||||
Commitments and Contingencies |
||||||||||||
Preferred stock, no par value, 7,500,000 shares
authorized; 2,155,715 Series A shares issued and
outstanding at September 30, 2003 and December 31, 2002
(aggregate liquidation preference of $10,000 at September
30, 2003 and December 31, 2002) |
5,081 | 5,081 | ||||||||||
Stockholders equity: |
||||||||||||
Preferred stock, no par value, 10,000
Series B shares issued and outstanding at
September 30, 2003, net of issuance costs
(aggregate liquidation preference of
$10,000 at September 30, 2003) |
9,178 | | ||||||||||
Common stock, no par value, 105,000,000
shares authorized; 44,342,808 and
38,676,592 shares issued and outstanding at
September 30, 2003 and December 31, 2002,
respectively |
84,263 | 77,528 | ||||||||||
Deferred compensation |
(20 | ) | (22 | ) | ||||||||
Accumulated deficit |
(83,044 | ) | (76,968 | ) | ||||||||
Accumulated other comprehensive loss |
| (42 | ) | |||||||||
Total stockholders equity |
10,377 | 496 | ||||||||||
Total liabilities and
stockholders equity |
$ | 24,603 | $ | 12,766 | ||||||||
See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
| Three Months Ended | Nine Months Ended | |||||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||||
Revenues: |
||||||||||||||||||
Net product sales |
$ | 3,943 | $ | 3,772 | $ | 9,185 | $ | 10,885 | ||||||||||
Grant and royalty revenue |
24 | 26 | 58 | 158 | ||||||||||||||
Technology revenue |
| | 250 | 250 | ||||||||||||||
Services revenue from a related party |
| 50 | | 150 | ||||||||||||||
Total revenues |
3,967 | 3,848 | 9,493 | 11,443 | ||||||||||||||
Operating costs and expenses: |
||||||||||||||||||
Cost of product sales |
796 | 881 | 2,620 | 2,243 | ||||||||||||||
Selling, general and administrative |
2,630 | 2,892 | 7,950 | 8,666 | ||||||||||||||
Research and development |
590 | 582 | 1,912 | 1,692 | ||||||||||||||
Depreciation and amortization |
441 | 262 | 822 | 921 | ||||||||||||||
Total operating costs and expenses |
4,457 | 4,617 | 13,304 | 13,522 | ||||||||||||||
Loss from operations |
(490 | ) | (769 | ) | (3,811 | ) | (2,079 | ) | ||||||||||
Non-cash amortization of deemed discount
on convertible debentures |
(130 | ) | (130 | ) | (391 | ) | (305 | ) | ||||||||||
Interest income (expense), net |
(18 | ) | (11 | ) | (32 | ) | 3 | |||||||||||
Other income (expense), net |
5 | (151 | ) | (75 | ) | (261 | ) | |||||||||||
Rental income, net |
57 | 66 | 194 | 212 | ||||||||||||||
Net loss |
(576 | ) | (995 | ) | (4,115 | ) | (2,430 | ) | ||||||||||
Non-cash deemed dividend related to
beneficial conversion feature of Series B
Preferred Stock |
| | 1,394 | | ||||||||||||||
Dividends on Series B Preferred Stock |
200 | | 567 | | ||||||||||||||
Net loss applicable to common stockholders |
$ | (776 | ) | $ | (995 | ) | $ | (6,076 | ) | $ | (2,430 | ) | ||||||
Shares used in computing basic and diluted
net loss per share applicable to
common stockholders |
44,275 | 38,632 | 40,987 | 38,317 | ||||||||||||||
Basic and diluted net loss per share
applicable to common stockholders |
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.15 | ) | $ | (0.06 | ) | ||||||
See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(IN THOUSANDS)
| Nine Months Ended | |||||||||
| September 30, | September 30, | ||||||||
| 2003 | 2002 | ||||||||
OPERATING ACTIVITIES |
|||||||||
Net loss |
$ | (4,115 | ) | $ | (2,430 | ) | |||
Adjustments to reconcile net loss to net cash
used in operating activities: |
|||||||||
Stock-based compensation expense |
40 | 311 | |||||||
Amortization of deemed discount on convertible debentures |
391 | 305 | |||||||
Amortization of deferred compensation |
44 | | |||||||
Depreciation and amortization |
822 | 921 | |||||||
Other-than-temporary loss on investment |
51 | 367 | |||||||
Deferred rent expense |
29 | (77 | ) | ||||||
Loss on the sale of investments |
14 | | |||||||
(Gain)/loss on the sale of equipment, net |
9 | (37 | ) | ||||||
Changes in operating assets and liabilities: |
|||||||||
Accounts receivable |
(554 | ) | 260 | ||||||
Inventories |
(631 | ) | (340 | ) | |||||
Prepaid expenses and other current assets |
366 | (523 | ) | ||||||
Accounts payable |
(205 | ) | 275 | ||||||
Accrued compensation |
(275 | ) | 192 | ||||||
Other accrued liabilities |
(147 | ) | 536 | ||||||
Other non-current liabilities |
67 | | |||||||
Net cash flows used in operating activities |
(4,094 | ) | (240 | ) | |||||
INVESTING ACTIVITIES |
|||||||||
Purchase of property and equipment |
(307 | ) | (323 | ) | |||||
Purchase of short-term investments |
(3,029 | ) | | ||||||
Acquisition of purchased technology |
(12,113 | ) | | ||||||
Proceeds from maturities and sales of short-term investments |
1,818 | | |||||||
Proceeds from sale of property and equipment |
23 | 51 | |||||||
Decrease in other assets |
2 | 142 | |||||||
Net cash flows used in investing activities |
(13,606 | ) | (130 | ) | |||||
FINANCING ACTIVITIES |
|||||||||
Issuance of common stock, net of issuance costs |
5,058 | 557 | |||||||
Issuance of Series B preferred stock and
warrants, net of issuance costs |
9,404 | | |||||||
Issuance of convertible debentures |
| 4,000 | |||||||
Short-term borrowings |
465 | 1,172 | |||||||
Repayment of note payable to bank |
| (5,000 | ) | ||||||
Repayment of short-term and long-term debt |
(531 | ) | (1,296 | ) | |||||
Payment of Series B preferred stock dividends |
(567 | ) | | ||||||
Repayments of capital lease obligations |
(1 | ) | (43 | ) | |||||
Net cash flows provided by/(used in) financing activities |
13,828 | (610 | ) | ||||||
Decrease in cash and cash equivalents |
(3,872 | ) | (980 | ) | |||||
Cash and cash equivalents at beginning of period |
6,156 | 10,183 | |||||||
Cash and cash equivalents at end of period |
$ | 2,284 | $ | 9,203 | |||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|||||||||
Cash paid for interest |
$ | 250 | $ | 150 | |||||
Amount payable relating to product acquisition |
$ | 2,183 | $ | | |||||
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED SEPTEMBER 30, 2003 FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company that acquires, develops, markets and sells brand name prescription drugs through a U.S. direct sales force and overseas distributors. The Company focuses on the treatment of conditions, including central nervous system (CNS) diseases and gastroenterological disorders which are served by a concentrated group of physicians, such as neurologists and gastroenterologists. The Companys strategy is to acquire pharmaceutical products that it believes have sales growth potential, are promotionally responsive to a focused, targeted sales and marketing effort and complement the Companys existing products. In addition, through corporate collaborations, the Company intends to develop new patented intranasal formulations of previously FDA approved drugs. The Company currently markets five products in the U.S.: HP Acthar® Gel (Acthar), an injectable drug that is approved for the treatment of certain CNS disorders with an inflammatory component including the treatment of flares associated with Multiple Sclerosis (MS) and is commonly used in treating patients with infantile spasm; Nascobal®, the only prescription nasal gel used for the treatment of various Vitamin B-12 deficiencies; Ethamolin®, an injectable drug used to treat enlarged weakened blood vessels at the entrance to the stomach that have recently bled, known as esophageal varices; Glofil®-125, which is an injectable agent that assesses how well the kidney is working by measuring glomerular filtration rate, or kidney function; and VSL#3, a patented probiotic marketed as a dietary supplement to promote normal gastrointestinal function. Probiotics are living organisms in food and dietary supplements, which, upon ingestion in certain numbers, improve the health of the host beyond their inherent basic nutrition. Due to minimal demand and increasing production costs, the Company discontinued marketing and selling Inulin in Sodium Chloride on September 30, 2003. On June 17, 2003, the Company acquired Nascobal®, a nasal gel formulation of Cyanocobalamin USP (Vitamin B-12), from Nastech Pharmaceutical Company, Inc. (Nastech). The Company began distributing Nascobal in July 2003. The Company markets Nascobal for patients with severe deficiencies of Vitamin B-12 associated with MS and Crohns Disease as these patients are at high risk of developing severe deficiencies of Vitamin B-12 due to a compromised ability to absorb Vitamin B-12 through the gastrointestinal system. In June 2002, the Company signed a license agreement with Fabre Kramer Pharmaceuticals, Inc., whereby Fabre Kramer will manage and provide funding for the clinical development programs for Hypnostat (an intranasal triazolam for the treatment of insomnia) and Panistat (an intranasal alprazolam for the treatment of panic disorders).
The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States and applicable Securities and Exchange Commission regulations for interim financial information. These financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. The unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes included in the Companys Annual Report on Form 10-K for the year ended December 31, 2002, as filed on March 26, 2003 with the Securities and Exchange Commission. The accompanying balance sheet at December 31, 2002 has been derived from the audited financial statements at that date. In the opinion of the Companys management, all adjustments (consisting of normal recurring adjustments) considered necessary for the fair presentation of interim financial information have been included. Operating results for the interim periods presented are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. Certain amounts in the prior quarters financial statements have been reclassified to conform with the current quarters presentation. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.
2. RECENTLY ISSUED ACCOUNTING STANDARDS
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. This Statement establishes new standards for how an issuer classifies and measures certain financial instruments with characteristics of both liabilities and equity. It requires that an issuer classify a financial instrument that is within its scope as a liability (or an asset in some circumstances). This Statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The adoption of SFAS No. 150 on July 1, 2003 did not have a material impact on the Consolidated Financial Statements.
In November 2002, the Emerging Issues Task Force (or EITF) of the Financial Accounting Standards Board (or FASB) issued EITF 00-21, Revenue Arrangements with Multiple Deliverables, which addresses certain aspects of the accounting for arrangements that involve the delivery or performance of multiple products, services and/or rights to use assets. Under EITF 00-21, revenue arrangements with multiple deliverables should be divided into separate units of accounting if the deliverables meet certain criteria, including whether the fair value of the delivered items can be determined and whether there is evidence of fair value of the undelivered items. In addition, the consideration should be allocated among the separate units of accounting based on their fair values, and the applicable revenue recognition criteria should be considered separately for each of the separate units of accounting. EITF 00-21
6
is effective for revenue arrangements the Company enters into after June 30, 2003. The adoption of EITF 00-21 did not have a material impact on the Consolidated Financial Statements as of September 30, 2003. The Company will evaluate the impact of EITF 00-21 on future revenue arrangements it enters into.
3. STOCK-BASED COMPENSATION
The Company generally grants stock options to its employees for a fixed number of shares with an exercise price equal to the fair value of the shares on the date of grant. As allowed under Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (SFAS 123), the Company has elected to follow Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees and related interpretations in accounting for stock awards to employees. Accordingly, no compensation expense is recognized in the Companys financial statements in connection with stock options granted to employees with exercise prices not less than fair value. Deferred compensation for options granted to employees is determined as the difference between the fair value of the Companys common stock on the date options were granted and the exercise price. For purposes of disclosures pursuant to SFAS 123, as amended by Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation Transition and Disclosure, the estimated fair value of options is amortized to expense over the options vesting periods.
Compensation expense for options granted to non-employees has been determined in accordance with SFAS 123 and EITF 96-18, Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in conjunction with Selling Goods or Services, as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Compensation expense for options granted to non-employees is periodically re-measured as the underlying options vest.
The following table illustrates the effect on net loss per common share if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net loss applicable to common stockholders as reported |
$ | (776 | ) | $ | (995 | ) | $ | (6,076 | ) | $ | (2,430 | ) | |||||
Add: Stock-based employee compensation expense
included in reported net loss |
37 | 2 | 51 | 9 | |||||||||||||
Deduct: Total stock-based employee compensation
expense determined under fair value method for all
awards |
(343 | ) | (303 | ) | (1,010 | ) | (1,076 | ) | |||||||||
Net loss applicable to common stockholders, pro forma |
$ | (1,082 | ) | $ | (1,296 | ) | $ | (7,035 | ) | $ | (3,497 | ) | |||||
Basic and diluted net loss per share
applicable to common stockholders: |
|||||||||||||||||
As reported |
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.15 | ) | $ | (0.06 | ) | |||||