UNITED STATES
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 MARCH 31, 2003
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:
0-20772
QUESTCOR PHARMACEUTICALS, INC.
| CALIFORNIA | 33-0476164 | |
| (State or other jurisdiction | (I.R.S.Employer | |
| of incorporation or organization) | 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 o
Indicate by check mark whether Registrant is an accelerated filer (as defined in Rule 12B-2 of the Act). Yes o No x
At May 9, 2003 there were 38,992,419 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 | ||||
| Item 1 | Financial Statements and Notes (Unaudited) | |||
| Condensed Consolidated Balance SheetsMarch 31, 2003 and December 31, 2002 | 3 | |||
| Condensed Consolidated Statements of Operationsfor the three months ended March 31, 2003 and 2002 | 4 | |||
| Condensed Consolidated Statements of Cash Flowsfor the three months ended March 31, 2003 and 2002 | 5 | |||
| Notes to Condensed Consolidated Financial Statements | 6 | |||
| Independent Accountants Review Report | 11 | |||
| Item 2 | Managements Discussion and Analysis of Financial Condition and Results of Operations | 12 | ||
| Item 3 | Quantitative and Qualitative Disclosures about Market Risk | 16 | ||
| Item 4 | Disclosure Controls and Procedures | 16 | ||
| PART II. OTHER INFORMATION | ||||
| Item 1 | Legal Proceedings | 17 | ||
| Item 2 | Changes in Securities and Use of Proceeds | 17 | ||
| Item 3 | Defaults upon Senior Securities | 17 | ||
| Item 4 | Submission of Matters to a Vote of Security Holders | 17 | ||
| Item 5 | Other Information | 17 | ||
| Item 6 | Exhibits and Reports | 17 | ||
| Signatures | 18 | |||
| Certifications | 19 | |||
2
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARES)
| March 31, | December 31, | |||||||||||
| 2003 | 2002 | |||||||||||
| (Unaudited) | (Note 1) | |||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ | 11,822 | $ | 6,156 | ||||||||
Short-term investments |
3,113 | 1,350 | ||||||||||
Accounts receivable, net of allowance for doubtful accounts of $20 at March 31, 2003 and
December 31, 2002 |
1,561 | 1,590 | ||||||||||
Inventories, net |
1,063 | 391 | ||||||||||
Prepaid expenses and other current assets |
911 | 979 | ||||||||||
Total current assets |
18,470 | 10,466 | ||||||||||
Property and equipment, net |
696 | 585 | ||||||||||
Purchased technology, net |
269 | 382 | ||||||||||
Goodwill and other indefinite lived intangible assets |
479 | 479 | ||||||||||
Deposits and other assets |
846 | 854 | ||||||||||
Total assets |
$ | 20,760 | $ | 12,766 | ||||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ | 2,111 | $ | 1,230 | ||||||||
Accrued compensation |
428 | 794 | ||||||||||
Other accrued liabilities |
1,046 | 1,205 | ||||||||||
Short-term debt and current portion of long-term debt |
230 | 218 | ||||||||||
Current portion of capital lease obligations |
| 1 | ||||||||||
Total current liabilities |
3,815 | 3,448 | ||||||||||
Convertible debentures, (face amount of $4,000), net of deemed discount of $969 at March 31, 2003
and $1,092 at December 31, 2002 |
3,031 | 2,908 | ||||||||||
Other non-current liabilities |
822 | 833 | ||||||||||
Commitments |
||||||||||||
Preferred stock, no par value, 7,500,000 shares authorized; 2,155,715 Series A shares issued and
outstanding at March 31, 2003 and December 31, 2002 (aggregate liquidation of $10,000 at March
31, 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 March 31, 2003, net of issuance costs |
9,178 | | ||||||||||
Common
stock, no par value, 75,000,000 shares authorized; 38,992,419 and 38,676,592 shares issued
and outstanding at March 31, 2003 and December 31, 2002, respectively |
79,070 | 77,528 | ||||||||||
Deferred compensation |
(30 | ) | (22 | ) | ||||||||
Accumulated deficit |
(80,206 | ) | (76,968 | ) | ||||||||
Accumulated other comprehensive loss |
(1 | ) | (42 | ) | ||||||||
Total stockholders equity |
8,011 | 496 | ||||||||||
Total liabilities and stockholders equity |
$ | 20,760 | $ | 12,766 | ||||||||
See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
| Three Months Ended | |||||||||||
| March 31, | March 31, | ||||||||||
| 2003 | 2002 | ||||||||||
Revenues: |
|||||||||||
Net product sales |
$ | 2,362 | $ | 3,806 | |||||||
Contract research and grant revenue |
9 | 45 | |||||||||
Technology revenue |
250 | | |||||||||
Royalty revenue |
| 3 | |||||||||
Total revenues |
2,621 | 3,854 | |||||||||
Operating costs and expenses: |
|||||||||||
Cost of product sales |
675 | 634 | |||||||||
Sales and marketing |
1,485 | 1,375 | |||||||||
General and administrative |
1,318 | 1,531 | |||||||||
Research and development |
611 | 428 | |||||||||
Depreciation and amortization |
169 | 344 | |||||||||
Total operating costs and expenses |
4,258 | 4,312 | |||||||||
Loss from operations |
(1,637 | ) | (458 | ) | |||||||
Non-cash amortization of deemed discount on convertible debentures |
(131 | ) | (44 | ) | |||||||
Interest income, net |
4 | 27 | |||||||||
Other income (expense), net |
(77 | ) | 71 | ||||||||
Rental income, net |
71 | 72 | |||||||||
Net loss |
$ | (1,770 | ) | $ | (332 | ) | |||||
Non-cash deemed dividend related to beneficial conversion feature of Series B Preferred Stock |
1,301 | | |||||||||
Dividends
on Series B Preferred Stock |
167 | | |||||||||
Net loss available to common stockholders |
$ | (3,238 | ) | $ | (332 | ) | |||||
Basic
and diluted net loss per share available to common stockholders |
$ | (0.08 | ) | $ | (0.01 | ) | |||||
Weighted average shares of common stock outstanding |
38,677 | 37,843 | |||||||||
See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(IN THOUSANDS)
| Three Months Ended | |||||||||
| March 31, | March 31, | ||||||||
| 2003 | 2002 | ||||||||
OPERATING ACTIVITIES |
|||||||||
Net loss |
$ | (1,770 | ) | $ | (332 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||
Stock based compensation expense |
8 | 263 | |||||||
Amortization of deemed discount on convertible debentures |
131 | 44 | |||||||
Amortization of deferred compensation |
7 | 4 | |||||||
Depreciation and amortization |
169 | 344 | |||||||
Deferred rent expense |
(11 | ) | (11 | ) | |||||
Other-than-temporary loss on investment |
51 | | |||||||
Loss on the sale of investments |
13 | | |||||||
(Gain)/loss on the sale of equipment, net |
13 | (2 | ) | ||||||
Changes in operating assets and liabilities: |
|||||||||
Accounts receivable |
29 | (280 | ) | ||||||
Inventories |
(672 | ) | 64 | ||||||
Prepaid expenses and other current assets |
59 | (817 | ) | ||||||
Accounts payable |
881 | 424 | |||||||
Accrued compensation and employee benefits |
(366 | ) | (108 | ) | |||||
Other accrued liabilities |
(327 | ) | 46 | ||||||
Net cash flows used in operating activities |
(1,785 | ) | (361 | ) | |||||
INVESTING ACTIVITIES |
|||||||||
Purchase of property and equipment |
(194 | ) | (67 | ) | |||||
Purchases of short-term investments |
(2,048 | ) | | ||||||
Proceeds from maturities and sales of short-term investments |
263 | | |||||||
Proceeds from sale of property and equipment |
15 | 13 | |||||||
Decrease in other assets |
| 44 | |||||||
Net cash flows used in investing activities |
(1,964 | ) | (10 | ) | |||||
FINANCING ACTIVITIES |
|||||||||
Issuance of common stock, net |
| 348 | |||||||
Issuance
of Series B preferred stock and warrants, net |
9,404 | | |||||||
Issuance of convertible debentures |
| 4,000 | |||||||
Short-term borrowings |
288 | 1,019 | |||||||
Repayment of note payable to bank |
| (5,000 | ) | ||||||
Repayment of short-term and long-term debt |
(276 | ) | (102 | ) | |||||
Repayments of capital lease obligations |
(1 | ) | (14 | ) | |||||
Net cash flows provided by financing activities |
9,415 | 251 | |||||||
Increase/(decrease) in cash and cash equivalents |
5,666 | (120 | ) | ||||||
Cash and cash equivalents at beginning of period |
6,156 | 10,183 | |||||||
Cash and cash equivalents at end of period |
$ | 11,822 | $ | 10,063 | |||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
|||||||||
Cash paid for interest |
$ | 87 | $ | 33 | |||||
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED MARCH 31, 2003 FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (The Company) is a specialty pharmaceutical company that markets and sells brand name prescription drugs and ethically promoted healthcare products. The Company focuses on the treatment of acute and critical care conditions, including central nervous system (CNS) diseases and gastroenterological disorders. The Companys strategy is to acquire pharmaceutical products that it believes have sales growth potential, are promotion sensitive 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 commonly used in treating patients with infantile spasm, and is approved for the treatment of certain CNS disorders with an inflammatory component including the treatment of flares associated with Multiple Sclerosis (MS); 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 and Inulin in Sodium Chloride, which are both injectable agents that assess 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. Emitasol is used for the treatment of acute chemotherapy induced nausea and vomiting, as well as functional dyspepsia and other motor disturbances of the gastrointestinal tract. Emitasol is currently marketed in Korea and is available under the trade name Pramidin® in Italy.
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 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. 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 the 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 (APB 25) 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 deemed fair market 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 SFAS 148, 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 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 share if we had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):
| Three months ended March 31, | |||||||||
| 2003 | 2002 | ||||||||
Net loss available to common stockholders as reported |
$ | (3,238 | ) | $ | (332 | ) | |||
Add: Stock-based employee compensation expense included in
reported net loss |
7 | 4 | |||||||
Deduct: Total stock-based employee compensation expense
determined under fair value method for all awards |
(356 | ) | (355 | ) | |||||
Pro forma net loss available to common stockholders |
$ | (3,587 | ) | $ | (683 | ) | |||
Basic and diluted net loss per share available to common
stockholders: |
|||||||||
As reported |
$ | (0.08 | ) | $ | (0.01 | ) | |||
Pro forma |
$ | (0.09 | ) | $ | (0.02 | ) | |||
3. REVENUE RECOGNITION
Revenues from product sales of Acthar, Ethamolin, Glofil-125, Inulin and VSL#3 are recognized based upon shipping terms, net of estimated reserves for sales returns, government chargebacks, Medicaid rebates, and discounts. Revenue is recognized upon shipment of product, provided the title to the products has been transferred at the point of shipment. If title of product transfers at point of receipt by the customer, revenue is recognized upon customer receipt of the shipment. The Company records estimated sales allowances against product revenues for expected returns, chargebacks, Medicaid rebates and discounts based on historical sales returns, chargebacks, and Medicaid rebates, analysis of return merchandise authorization and other known factors such as shelf life of products, as required. The Company continually assesses the historical returns and other experience including customers compliance with return goods policy and adjusts its allowances as appropriate. The Companys return policy allows customers to return expired product for exchange within six months beyond the expiration date. Effective August 12, 2002 the Company changed its return goods policy such that it no longer issues credit memorandums for returns. Rather, returns are exchanged for replacement product, and estimated costs for such exchanges, which include actual product material costs and related shipping charges, are included in Cost of product sales. Returns are subject to quality assurance reviews prior to acceptance. The Company sells product to wholesalers, who in turn sell its products to pharmacies and hospitals. In the case of VSL#3, the Company sells directly to consumers. The Company does not require collateral from its customers.
Revenue earned under collaborative research agreements is recognized as the research services are performed. Amounts received in advance of services to be performed are recorded as deferred revenue until the services are performed.
The Company has received government grants which support the Companys research effort in specific research projects. These grants provide for reimbursement of approved costs incurred as defined in the various awards.
6
The Company has received payments in exchange for proprietary licenses related to technology and patents. The Company classifies these payments as Technology Revenue. These payments are recognized as revenues upon receipt of cash and the transfer of intellectual property, data and other rights licensed, assuming no continuing material obligations exist.
Shipping and handling costs are included in Cost of product sales.
4. CASH AND CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
The Company considers highly liquid investments with maturities from the date of purchase of three months or less to be cash equivalents. At March 31, 2003, the Company had cash, cash equivalents and short-term investments of $14,935,000.
Following is a summary of investments, at fair value, based on quoted market prices for these investments (in thousands):
| Gross | Gross | Estimated | |||||||||||
| March 31, 2003 | Amortized Cost | Unrealized Loss | Fair Value | ||||||||||
Cash equivalents: |
|||||||||||||
Money Market Funds |
$ | 7,581 | $ | | $ | 7,581 | |||||||
Commercial Paper |
3,247 | | 3,247 | ||||||||||
Corporate Bonds |
752 | | 752 | ||||||||||
| $ | 11,580 | | $ | 11,580 | |||||||||
Short-term investments: |
|||||||||||||
Commercial Paper |
$ | 499 | $ | (1 | ) | $ | 498 | ||||||
Corporate Bonds |
2,559 | | 2,559 | ||||||||||
Corporate Equity Investments |
56 | | 56 | ||||||||||
| $ | 3,114 | $ | (1 | ) | $ | 3,113 | |||||||
| Gross | Gross | Estimated | |||||||||||
| December 31, 2002 | Amortized Cost | Unrealized Loss | Fair Value | ||||||||||
Cash equivalents: |
|||||||||||||
Money Market Funds |
$ | 5,400 | $ | | $ | 5,400 | |||||||
Commercial Paper |
499 | | 499 | ||||||||||
| $ | 5,899 | $ | | $ | 5,899 | ||||||||
Short-term investments: |
|||||||||||||
Commercial Paper |
$ | 498 | $ | | $ | 498 | |||||||
Corporate Bonds |
761 | | 761 | ||||||||||
Corporate Equity Investments |
133 | (42 | ) | 91 | |||||||||
| $ | 1,392 | $ | (42 | ) | |||||||||