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 MARCH 31, 2004 | ||
| 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 (State or other jurisdiction of incorporation or organization) |
33-0476164 (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 May 7, 2004 there were 51,060,220 shares of the Registrants common stock, no par value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
| (Unaudited) | (Note 1) | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 6,173 | $ | 3,220 | ||||
Accounts receivable, net of allowances of $60 at March 31, 2004 and
December 31, 2003, respectively |
1,976 | 2,161 | ||||||
Inventories, net |
1,017 | 1,050 | ||||||
Prepaid expenses and other current assets |
956 | 873 | ||||||
Total current assets |
10,122 | 7,304 | ||||||
Property and equipment, net |
720 | 609 | ||||||
Purchased technology, net |
13,473 | 13,709 | ||||||
Goodwill and other indefinite lived intangible assets |
479 | 479 | ||||||
Deposits and other assets |
820 | 828 | ||||||
Total assets |
$ | 25,614 | $ | 22,929 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,456 | $ | 1,402 | ||||
Accrued compensation |
312 | 358 | ||||||
Other accrued liabilities |
1,028 | 1,052 | ||||||
Short-term debt |
168 | 140 | ||||||
Convertible debentures, (face amount of $4,000), net of
deemed discount of $474 at March 31, 2004, current portion |
3,526 | | ||||||
Total current liabilities |
6,490 | 2,952 | ||||||
Convertible debentures, (face amount of $4,000), net of
deemed discount of $598 at December 31, 2003 |
| 3,402 | ||||||
Other non-current liabilities |
926 | 916 | ||||||
Commitments and contingencies |
||||||||
Preferred stock, no par value, 7,500,000 shares authorized;
2,155,715 Series A shares issued and outstanding at
March 31, 2004 and December 31, 2003 (aggregate
liquidation preference of $10,000 at March 31, 2004 and
December 31, 2003) |
5,081 | 5,081 | ||||||
Stockholders equity: |
||||||||
Preferred stock, no par value, 8,400 and 9,100 Series B shares
issued and
outstanding at March 31, 2004 and December
31, 2003, respectively,
net of issuance costs (aggregate liquidation preference of $8,400
and $9,100 at March 31, 2004 and December 31, 2003, respectively) |
7,578 | 8,278 | ||||||
Common stock, no par value, 105,000,000 shares authorized;
51,060,220 and 45,387,802 shares issued and outstanding at March
31, 2004 and December 31, 2003, respectively |
88,377 | 85,232 | ||||||
Deferred compensation |
(21 | ) | (17 | ) | ||||
Accumulated deficit |
(82,817 | ) | (82,915 | ) | ||||
Total stockholders equity |
13,117 | 10,578 | ||||||
Total liabilities and stockholders equity |
$ | 25,614 | $ | 22,929 | ||||
See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Revenues: |
||||||||
Net product sales |
$ | 5,148 | $ | 2,362 | ||||
Technology, contract research, grant and royalty revenue |
| 259 | ||||||
Total revenues |
5,148 | 2,621 | ||||||
Operating costs and expenses: |
||||||||
Cost of product sales |
856 | 675 | ||||||
Selling, general and administrative |
3,028 | 2,803 | ||||||
Research and development |
578 | 611 | ||||||
Depreciation and amortization |
298 | 169 | ||||||
Total operating costs and expenses |
4,760 | 4,258 | ||||||
Income (loss) from operations |
388 | (1,637 | ) | |||||
Non-cash amortization of deemed discount on
convertible debentures |
(131 | ) | (131 | ) | ||||
Interest income (expense), net |
(72 | ) | 4 | |||||
Other income (expense), net |
3 | (77 | ) | |||||
Rental income, net |
82 | 71 | ||||||
Net income (loss) |
270 | (1,770 | ) | |||||
Non-cash deemed dividend related to beneficial
conversion feature of Series B Preferred Stock |
| 1,301 | ||||||
Dividends on Series B Preferred Stock |
172 | 167 | ||||||
Net income (loss) applicable to common stockholders |
$ | 98 | $ | (3,238 | ) | |||
Basic and diluted net income (loss) per share
applicable to common stockholders |
$ | 0.00 | $ | (0.08 | ) | |||
Shares used in computing basic and diluted net income (loss)
per share applicable to common stockholders |
50,032 | 38,677 | ||||||
See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
OPERATING ACTIVITIES |
||||||||
Net income (loss) |
$ | 270 | $ | (1,770 | ) | |||
Adjustments to reconcile net income (loss) to net
cash provided by (used in) operating activities: |
||||||||
Stock-based compensation expense |
10 | 8 | ||||||
Amortization of deemed discount on convertible debentures |
131 | 131 | ||||||
Amortization of deferred compensation |
2 | 7 | ||||||
Depreciation and amortization |
298 | 169 | ||||||
Other-than-temporary loss on investment |
| 51 | ||||||
Deferred rent expense |
10 | (11 | ) | |||||
Loss on the sale of investments |
| 13 | ||||||
Loss on the sale of equipment, net |
| 13 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
185 | 29 | ||||||
Inventories |
33 | (672 | ) | |||||
Prepaid expenses and other current assets |
(67 | ) | 59 | |||||
Accounts payable |
54 | 881 | ||||||
Accrued compensation |
(46 | ) | (366 | ) | ||||
Other accrued liabilities |
(24 | ) | (327 | ) | ||||
Net cash flows provided by (used in) operating activities |
856 | (1,785 | ) | |||||
INVESTING ACTIVITIES |
||||||||
Purchase of property and equipment |
(173 | ) | (194 | ) | ||||
Purchase of short-term investments |
| (2,048 | ) | |||||
Proceeds from maturities and sales of short-term investments |
| 263 | ||||||
Proceeds from sale of property and equipment |
| 15 | ||||||
Decrease in other assets |
1 | | ||||||
Net cash flows used in investing activities |
(172 | ) | (1,964 | ) | ||||
FINANCING ACTIVITIES |
||||||||
Issuance of common stock, net of issuance costs |
2,409 | | ||||||
Issuance of Series B preferred stock and warrants, net of
issuance costs |
| 9,404 | ||||||
Short-term borrowings |
211 | 288 | ||||||
Repayment of short-term and long-term debt |
(183 | ) | (276 | ) | ||||
Payment of Series B preferred stock dividends |
(168 | ) | | |||||
Repayments of capital lease obligations |
| (1 | ) | |||||
Net cash flows provided by financing
activities |
2,269 | 9,415 | ||||||
Increase in cash and cash equivalents |
2,953 | 5,666 | ||||||
Cash and cash equivalents at beginning of period |
3,220 | 6,156 | ||||||
Cash and cash equivalents at end of period |
$ | 6,173 | $ | 11,822 | ||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION: |
||||||||
Cash paid for interest |
$ | 83 | $ | 87 | ||||
NON-CASH INVESTING AND FINANCING ACTIVITIES: |
||||||||
Common stock
issued upon conversion of Series B preferred stock and accrued dividends
for Series B preferred stock |
$ | 704 | $ | | ||||
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED MARCH 31, 2004 FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company that acquires, markets and sells brand name prescription drugs through a U.S. direct sales force and international distributors. The Company focuses on the treatment of central nervous system (CNS) diseases and gastroenterological disorders which are served by a limited group of physicians such as neurologists, gastroenterologists, and bariatric surgeons. The Companys strategy is to acquire pharmaceutical products that it believes have sales growth potential, are promotionally responsive to a focused and targeted sales and marketing effort and complement the Companys existing products, and can be acquired at a reasonable valuation relative to our cost of capital. 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 also 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, 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. The Company acquired Nascobal, a nasal gel formulation of Cyanocobalamin USP (Vitamin B-12), from Nastech Pharmaceutical Company, Inc. in June 2003 and began distributing Nascobal in July 2003. The Company markets Nascobal for patients with Crohns Disease and MS, or who have undergone gastric bypass surgery, since 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.
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, 2003, as filed on March 30, 2004 with the Securities and Exchange Commission. The accompanying balance sheet at December 31, 2003 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, 2004. 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 market 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 market value. Deferred compensation for options granted to employees is determined as the difference between the 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 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.
The following table illustrates the effect on net income (loss) per share applicable to common stockholders if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):
6
| Three months ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Net income (loss) applicable to common
stockholders as reported |
$ | 98 | $ | (3,238 | ) | |||
Add: Stock-based employee
compensation expense included
in reported net loss |
5 | 7 | ||||||
Deduct: Total stock-based
employee compensation
expense determined
under fair value
method for all awards |
(145 | ) | (356 | ) | ||||
Net loss applicable to common
stockholders, pro forma |
$ | (42 | ) | $ | (3,587 | ) | ||
Basic and diluted net income (loss)
per share applicable to common
stockholders: |
||||||||
As reported |
$ | 0.00 | $ | (0.08 | ) | |||
Pro forma |
$ | (0.00 | ) | $ | (0.09 | ) | ||
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.
3. REVENUE RECOGNITION
Revenues from product sales of Acthar, Nascobal, Ethamolin, Glofil-125, Inulin and VSL#3 are recognized based upon shipping terms, net of estimated reserves for government chargebacks, Medicaid rebates, and payment 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 government chargebacks, Medicaid rebates and payment discounts based on historical chargebacks and discounts, as required. The Companys return policy allows customers to return expired product for exchange within six months beyond the expiration date. 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 records returns allowances for expected returns based upon historical returns, analysis of return merchandise authorizations and other factors such as shelf life. The Company routinely assesses the historical returns and other experience including customers compliance with return goods policy and adjusts its allowances as appropriate. Allowances for Medicaid rebates, government chargebacks and product returns are $589,000 and $582,000 at March 31, 2004 and December 31, 2003, respectively, and are included in Other Accrued Liabilities. 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.
The Company has received government grants that support the Companys research efforts in specific research projects. These grants provide for reimbursement of approved costs incurred as defined in the various awards.
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.
4. CASH AND CASH EQUIVALENTS
The Company considers highly liquid investments with maturities from the date of purchase of three months or less to be cash equivalents. The Company had cash and cash equivalents of $6,173,000 and $3,220,000 at March 31, 2004 and December 31, 2003, respectively, all in money market funds. The fair value of the funds approximated cost.
7
During the quarter ended March 31, 2003, the Company recognized an other-than-temporary loss of $51,000 and a realized loss of $13,000 related to its equity investment in Rigel Pharmaceuticals, Inc. (Rigel). These amounts are included in Other Income (Expense) on the accompanying Consolidated Statement of Operations. The Company liquidated its investment in Rigel common stock in the second quarter of fiscal year 2003.
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist of the following (in thousands):
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
Raw materials |
$ | 575 | $ | 534 | ||||
Work in process |
| 197 | ||||||
Finished goods |
795 | 660 | ||||||
Less allowance for excess and obsolete inventories |
(353 | ) | (341 | ) | ||||
| $ | 1,017 | $ | 1,050 | |||||
6. PURCHASED TECHNOLOGY AND INTANGIBLE ASSETS
Goodwill and assembled workforce no longer subject to amortization amounted to $479,000 at March 31, 2004 and December 31, 2003. The Company performed an impairment test of goodwill and assembled workforce as of December 31, 2003, which did not result in an impairment charge. The Company will continue to monitor the carrying value of goodwill and assembled workforce through the annual impairment tests or more frequently if indicators of potential impairment exist. As of March 31, 2004, no indicators of potential impairment existed. No such impairment losses have been recorded to date.
Purchased technology at March 31, 2004 includes $14.2 million related to the Nascobal acquisition. The Nascobal purchased technology is being amortized over its estimated life of 15 years. Accumulated amortization for the Nascobal purchased technology is $751,000 as of March 31, 2004.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences while the officer or director is or was serving at the Companys request in such capacity. The potential future indemnification limit is to the fullest extent permissible under California law; however, the Company has a director and officer insurance policy that limits its exposure and may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements as of March 31, 2004.
From time to time, the Company may become involved in claims and other legal matters arising in the ordinary course of business. Management is not currently aware of any such matters that will have a material adverse affect on the financial position, results of operations or cash flows of the Company.
8. NET INCOME (LOSS) PER SHARE APPLICABLE TO COMMON STOCKHOLDERS
Basic and diluted net income (loss) per share applicable to common stockholders is based on net income (loss) applicable to common stockholders for the relevant period, divided by the weighted average number of common shares outstanding during the period. Diluted earnings per share applicable to common stockholders gives effect to all potentially dilutive common shares outstanding during the period such as options, warrants, convertible preferred stock, and contingently issuable shares. Diluted net income per share applicable to common stockholders has not been presented separately for the period ended March 31, 2004 as basic net income per share is $0.00. Diluted net loss per share applicable to common stockholders has not been presented separately for the period ended March 31, 2003 since, due to the Companys net loss position, it is anti-dilutive. If the Companys net income per share applicable to common stockholders had been $0.01 or greater for the period ended March 31, 2004, then shares used in calculating diluted earnings per share applicable to common stockholders would have included, if dilutive, the effect of the outstanding 9,447,104 stock options to purchase common shares, 11,080,492 convertible preferred shares, 2,531,644 common shares issuable upon conversion of debentures, placement unit options for 127,678 common shares and 4,559,407 warrants to purchase common shares.
8
9. EQUITY TRANSACTIONS
In January 2004 the Company entered into agreements with some of its existing investors and issued 4,878,201 shares of common stock in exchange for $2,399,050 in cash and the surrender of outstanding warrants to purchase 3,878,201 shares of common stock. The warrants retired represented approximately 46% of the Companys warrants outstanding as of December 31, 2003. The warrants surrendered were included as consideration at their aggregate fair value of $743,000 which was determined using a Black-Scholes valuation method. The purchase price of the common stock, which was payable in cash and surrender of outstanding warrants, was $0.644 per share, which was the volume weighted average price of the Companys common stock for the five trading days prior to the agreement to the terms of the transaction. Sigma Tau participated in the transaction, purchasing 759,493 shares of common stock for aggregate consideration of $489,000 in cash and the surrender of 759,493 warrants to purchase common stock.
In January 2004, shares of the Companys Series B Preferred Stock with a stated value of $600,000 plus accrued dividends of $2,000 were converted into 640,147 shares of common stock.
In March 2004, shares of the Companys Series B Preferred Stock with a stated value of $100,000 plus accrued dividends of $1,600 were converted into 107,995 shares of common stock.
10. 2004 DIRECTORS STOCK OPTION PLAN
In February 2004, the Board of Directors adopted the 2004 Non-Employee Directors Equity Incentive Plan (the 2004 Plan). The adoption of the 2004 Plan is subject to shareholder approval at the Companys 2004 Annual Meeting of Shareholders. Under the terms of the 2004 Plan, 1,250,000 shares of the Companys common stock would be authorized for grants of non-qualified stock options to non-employee directors of the Company. The 2004 Plan provides for the granting of 25,000 options to purchase common stock upon appointment as a non-employee director and an additional 15,000 options each January thereafter upon reappointment. Such option grants will vest over four years and the exercise price of the options is 85% of the fair market value on the date of grant. Additionally, the 2004 Plan provides for the annual granting of 10,000 options to members of committees of the Board of Directors and an additional 7,500 options to chairmen of committees. Such option grants will have an exercise price equal to 100% of the fair market value of the Companys common stock on the date of the grant and will become fully vested at the time of grant. The maximum term of the options granted under the 2004 Plan is ten years.
11. SERIES B CONVERTIBLE PREFERRED STOCK
In January 2003, the Company completed a private placement of Series B Convertible Preferred Stock and warrants to purchase common stock to various investors. Gross proceeds to the Company from the private placement were $10 million. Net of issuance costs, the proceeds to the Company were $9.4 million. Of the original $10 million stated value, Series B Convertible Preferred Stock having a stated value of $1.6 million has been converted into common stock through March 31, 2004.
The holders of the Series B Convertible Preferred Stock have the right, upon the occurrence of certain designated optional redemption events, to require the Company to redeem the Series B Preferred Stock at 100% of stated value, together with all accrued and unpaid dividends and interest. The redemption events are all within the control of the Company. Therefore, in accordance with EITF Topic D-98, the Company has classified the Series B Preferred Stock in permanent equity. In addition, the Company initially recorded the Series B Preferred Stock at its fair value on the date of issuance. The Company has elected not to adjust the carrying value of the Series B Preferred Stock to the redemption value of such shares, since it is uncertain whether or when the redemption events will occur. Subsequent adjustments to increase the carrying value to the redemption value will be made when it becomes probable that such redemption will occur. As of March 31, 2004, the redemption value of the Series B Preferred Stock was $8.4 million.
The purchasers of the Series B Preferred Stock also received for no additional consideration warrants exercisable for an aggregate of 3,399,911 shares of Common Stock at an exercise price of $1.0824 per share, subject to certain anti-dilution adjustments. The warrants expire in January 2007. The warrants issued to the Series B holders were assigned a value of $1,527,000 which decreased the carrying value of the preferred stock. The warrants were valued using the Black-Scholes method with the following assumptions: a risk free interest rate of 3%; an expiration date of January 15, 2007; volatility of 82% and a dividend yield of 0%. In connection with the issuance of the Series B Preferred Stock and warrants, the Company recorded $1,301,000 related to the beneficial conversion feature on the Series B Preferred Stock as a deemed dividend, which increased the carrying value of the preferred stock. A beneficial conversion feature is present because the effective conversion price of the Series B Preferred Stock was less than the fair value of the Common Stock on the commitment date. For the quarter ended March 31, 2003, the deemed dividend increased the loss applicable to common stockholders in the calculation of basic and diluted net loss per common share.
9
12. RELATED PARTY TRANSACTIONS
In December 2001, the Company entered into a promotion agreement with VSL Pharmaceuticals Inc. (VSL), a private company owned in part by the major shareholders of Sigma Tau. Sigma Tau beneficially owned approximately 28% of the Companys outstanding stock as of March 31, 2004. In June 2002, the Company signed an amendment to the promotion agreement. Effective January 1, 2004, the promotion agreement and all amendments were assigned by VSL to Sigma Tau Pharmaceuticals, Inc. Under these agreements, the Company has agreed to purchase VSL#3 from VSL at a stated price, and has also agreed to promote, sell, warehouse and distribute the VSL#3 product direct to customers at its cost and expense, subject to certain expense reimbursements. Revenues from sales of VSL#3 are recognized when product is shipped to the customer. The Company does not accept returns of VSL#3. VSL#3 revenue for the quarter ending March 31, 2004 was $336,000 and is included in Net Product Sales. Included in Accounts Payable is $114,000 for amounts owed to VSL at March 31, 2004. An access fee to VSL is calculated quarterly, which varies based upon sales and costs incurred by the Company subject to reimbursement under certain circumstances. For the quarter ended March 31, 2004, the amount of the access fee was $67,000 and is included in Selling, General and Administrative expense in the accompanying Consolidated Statement of Operations. During the quarter ended March 31, 2004 the Company paid $240,000 to VSL for the purchase of VSL#3 product and access fees.
In January 2002, the Company entered into a royalty agreement with Glenridge Pharmaceuticals LLC (Glenridge). Kenneth R. Greathouse, the Companys former Vice President of Commercial Operations, is a part owner of Glenridge. Effective September 30, 2003, Mr. Greathouse ceased to be an officer of Questcor. The agreement calls for the payment of royalties on a quarterly basis on the net sales of Acthar. The Company paid Glenridge $69,000 and $95,000 in the quarters ended March 31, 2004 and 2003, respectively, related to royalties on Acthar sales. The Company has accrued $56,000 for royalties earned in the quarter ended March 31, 2004, which is included in Other Accrued Liabilities in the accompanying Consolidated Balance Sheet.
13. COMPREHENSIVE INCOME (LOSS)
Comprehensive income (loss) is comprised of net income (loss) and the change in unrealized holding gains and losses on available-for-sale securities.
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Net income (loss) |
$ | 270 | $ | (1,770 | ) | |||
Change in unrealized gains(losses) on
available-for-sale securities |
| 41 | ||||||
Comprehensive income (loss) |
$ | 270 | $ | (1,729 | ) | |||
10
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Except for the historical information contained herein, the following discussion contains forward-looking statements that involve risks and uncertainties, including statements regarding the period of time during which our existing capital resources and income from various sources will be adequate to satisfy our capital requirements. Our actual results could differ materially from those discussed herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this section, as well as those discussed in our annual report on Form 10-K for the fiscal year ended December 31, 2003, including Item 1 Business of Questcor Risk Factors, as well as factors discussed in any documents incorporated by reference herein or therein. Whenever used in this Quarterly Report, the terms Questcor, Company, we, our, ours, and us refer to Questcor Pharmaceuticals, Inc. and its consolidated subsidiaries.
Overview
We are a specialty pharmaceutical company that acquires, markets and sells brand name prescription drugs through our U.S. direct sales force and international distributors. We focus on the treatment of central nervous system (CNS) diseases and gastroenterological disorders which are served by a limited group of physicians such as neurologists, gastroenterologists and bariatric surgeons. Our strategy is to acquire pharmaceutical products that we believe have sales growth potential, are promotionally responsive to a focused and targeted sales and marketing effort and complement our existing products, and can be acquired at a reasonable valuation relative to our cost of capital. We currently market five products in the United States:
| | 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 also commonly used in treating patients with infantile spasm; | |||
| | Nascobal®, the only prescription nasal gel used for the treatment of various Vitamin B-12 deficiencies including Vitamin B-12 deficiencies associated with Crohns disease, gastric bypass surgery and 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, 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. | |||
In June 2003, we acquired Nascobal, an FDA approved nasal gel formulation of Cyanocobalamin USP (Vitamin B-12), from Nastech Pharmaceutical Company, Inc. (Nastech) for $14.2 million. We also agreed to acquire the rights to Nascobal spray, an improved dosage form, for which there will be two contingent payments to Nastech of $2 million each. Upon approval by the FDA of an NDA filed by Nastech for Nascobal spray, Nastech is obligated to transfer the NDA to us, and we are obligated to pay $2 million to Nastech. Upon subsequent issuance of a patent for the nasal spray, we are obligated to pay an additional $2 million to Nastech. We began distributing Nascobal in July 2003. We are marketing Nascobal for patients with Crohns Disease and MS, and patients who 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. We are also marketing Nascobal for patients who have undergone gastric bypass surgery, have inflammatory bowel disease, or other conditions that lead to a malabsorbtive state.
Consistent with our focus on sales and marketing, our spending on research and development activities is minimal. Expenses incurred for the Acthar manufacturing site transfer and medical and regulatory affairs are classified as Research and Development Expenses in the accompanying Consolidated Statements of Operations. We have entered into agreements with pharmaceutical and biotechnology companies to further the development of certain acquired technology. In June 2002, we signed a definitive License Agreement with Fabre Kramer Pharmaceuticals, Inc. (Fabre Kramer), whereby we granted Fabre Kramer exclusive worldwide rights to develop and commercialize HypnostatTM (intranasal triazolam for the treatment of insomnia) and PanistatTM (intranasal alprazolam for the treatment of panic disorders). We have granted rights to Rigel Pharmaceuticals, Inc. (Rigel) of South San Francisco, California for our antiviral drug discovery program, and granted rights to Dainippon Pharmaceuticals Co., Ltd. (Dainippon) of Osaka, Japan for our antibacterial program.
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We have incurred an accumulated deficit of $82.8 million at March 31, 2004. At March 31, 2004, we had $6.2 million in cash and cash equivalents. Results of operations may vary significantly from quarter to quarter depending on, among other factors, the results of our sales efforts, timing of expiration of our products and the resulting shipment of replacement product under our exchange policy, the availability of finished goods from our sole-source manufacturers, the timing of certain expenses including the Acthar site transfer costs and various market research and marketing planning expenses, the seasonality of sales of Ethamolin, the acquisition of marketed products, the establishment of strategic alliances and corporate partnering arrangements and the receipt of milestone payments.
Critical Accounting Policies
Our managements discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our estimates, including those related to product returns, sales allowances, bad debts, inventories, investments and intangible assets. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements.
Product Returns, Rebates and Sales Allowances
We have estimated allowances for product returns from wholesalers and pharmacies, government chargebacks for goods purchased by certain Federal government organizations including the Veterans Administration, Medicaid rebates to all states for goods purchased by patients covered by Medicaid, and cash discounts for prompt payment. We estimate our allowances by utilizing historical information for existing products and data obtained from external sources. For new products, we estimate our allowances for product returns, government chargebacks and rebates on specific terms for product returns, chargebacks and rebates, and our experience with similar products.
We have an exchange policy in which we exchange replacement product for product returns. The estimated costs for such potential exchanges, which include actual product costs and related shipping charges, are included in Cost of Product Sales. In estimating returns for each product, we analyze (i) historical returns and sales patterns, (ii) current inventory on hand at wholesalers and in the distribution channel, and the remaining shelf life of that inventory (ranging from 18 months to 3 years for all products except Glofil), and (iii) changes in demand measured by prescriptions as provided by an independent third party source and our internal estimates. For Glofil, we accept no returns for expired product. We routinely assess our historical experience including customers compliance with our exchange policy, and we adjust our allowances as appropriate.
In December 2002, we noted that certain customers were not complying with our exchange policy. These customers were deducting from amounts owed to us the full price of expired Acthar they planned to return to us. We reached an agreement with these customers to reverse these short-remittances and to accept replacement product. Certain customers received an administration fee from us. It remains our customers standard practice to deduct from payments to us the amount of the sales value of expired product, or returns receivable, that they have requested authorization to return. The returns receivable is $408,000 at March 31, 2004, primarily due to the return materials authorization requests for expired product from batches of Acthar that expired in November 2002, May 2003 and January 2004 and Ethamolin that expired in October 2003, January 2004 and February 2004. Customers have indicated that they will reimburse us for these deductions upon the replacement of expired units in accordance with our exchange policy, however, our experience has been the timing of such reimbursements is slower than the collection of our normal trade receivables. As of March 31, 2004, replacement units have been shipped with respect to approximately one third of the amounts owing to us and we are seeking reimbursement from these customers. As long as our customers standard practice is to deduct amounts related to the return of expired product, a returns receivable will arise. Should our customers not comply with our exchange policy, the amounts deducted by them for returns may not be collectible, and we would increase our allowance for bad debts.
Our exchange policy is not commonplace in the pharmaceutical industry. The standard policy in the industry is to issue credit memoranda in exchange for expired product that is returned. Our customers have expressed dissatisfaction with our exchange policy, and, although they have complied to date, our ability to enforce this policy in the future on customers whose influence and resources are far greater than ours may be minimal. If our customers do not comply with our exchange policy, our options may be limited. We
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could either not sell our products to them or we could be forced to change our exchange policy to allow for the issuance of credit memoranda in exchange for returned expired products. Under such a policy, we would no longer issue replacement product. The issuance of credit memoranda would negatively impact cash flow in the short-term but may increase future sales as shipment of replacement product at no cost would no longer occur.
Should we be forced to change to a returns policy in which credit memoranda are issued in exchange for expired product, an allowance for returns (credit memoranda) would be necessary and would be recorded with an offset to net product sales at the time of the policy change. The allowance would be based on an estimate of the future credit memoranda to be issued based upon historical return rates by product, applied to the quantity of product sold that has not yet expired. Further, if such a policy change were made the currently recorded allowance for product exchanges would be eliminated resulting in a reduction of cost of product sales. With respect to Acthar, the historical return rate has been approximately 18% to 20% due to the short shelf life of Acthar and the nature of the disease for which it is prescribed. A change in our business policy to a return for credit memoranda basis would have a significant negative financial impact at the time of the change. If we adopted a policy of issuing credit memoranda for expired product in the future, we may need allowances of up to $2 million to $3 million based on historical return rates for each product. A change in our exchange policy to issuing credit memoranda for expired product would be considered a change in accounting estimate and would be accounted for on a prospective basis. The impact of such a change would be to reduce net product sales by the amount of the estimated future credit memoranda to be issued offset by a reduction in cost of product sales for the elimination of the allowance for product replacement.
In March 2004, one of our three largest customers communicated to us that they do not want to continue complying with our exchange policy and would like to be issued credit memoranda for expired product. We have met with this customer and they have agreed to continue to adhere to our exchange policy for the time being. However, we offered, and are awaiting a response to, a proposal to the customer to transition in the future to a policy of issuing credit memoranda for returned product. Under the proposal, we would change to a credit memorandum policy for this customer commencing with shipments from the next lot of each product to be released. The next lot of Acthar would be released in June 2004, Nascobal would be released later in 2004 and Ethamolin in 2006. We would continue with the exchange policy through the return period (six months after expiration) for all lots of each product that have been shipped to date or that are currently being shipped for each product. In effect, under the transition plan the exchange policy would continue until all the currently released unexpired lots have passed their six month return period. Under the proposal for Acthar the current exchange policy would continue until June 2005, Ethamolin continues until October 2006 and Nascobal continues until May 2006, which is six months after the expiration of the lots already sold or currently being sold. Upon release of the new lot of each product, shipments thereafter would be subject to a credit memo policy for returns. Should our customer accept our proposal to transition to a policy in which credit memoranda are issued in exchange for expired product, an allowance for returns (credit memoranda) on future shipments would be necessary and would be recorded with an offset to net product sales as shipments from the new lots are released. The allowance would be based on an estimate of the future credit memoranda to be issued based upon historical return rates by product, applied to the quantity of product sold under the credit memo policy that has not yet expired. We are awaiting a response from the customer to our proposal. We do not know if this policy will be accepted in full by the customer.
In April 2004, another of our three largest customers verbally communicated their intention to implement new procedures which may impact our exchange policy. Preliminary discussion indicates that the customers new procedures may require us to change some of the administrative processes for handling returns. We are awaiting specifics as to their new procedures and the administrative changes that they request and at this time we are unable to assess the impact on the exchange policy or Questcors financial results.
In estimating Medicaid rebates, we match the actual rebates to the quantity of product sold by pharmacies on a product-by-product basis to arrive at an actual rebate percentage. This historical percentage is used to estimate a rebate percentage that is applied to the sales to which the rebates apply to arrive at the rebate expense (allowance) for the period. In particular, we consider allowable prices by Medicaid. In estimating government chargeback allowances, we analyze actual chargeback amounts by product and apply historical chargeback rates to sales to which chargebacks apply, typically sales to the Veterans Administration and other U.S. government organizations. We routinely assess our experience with Medicaid rebates and government chargebacks and adjust the allowances accordingly.
For qualified customers, we grant payment terms of 2%, net 30 days. Allowances for cash discounts are estimated based upon historical experience and the amount of trade accounts receivable subject to the cash discounts.
If actual product returns, government chargebacks, Medicaid rebates and cash discounts are greater than our estimates, or if our customers fail to adhere to our exchange policy, additional allowances may be required. To date, the actual amounts have approximated our estimates.
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Inventories
We maintain inventory reserves primarily for obsolescence (due to the expiration of shelf life of a product). In estimating inventory obsolescence reserves, we analyze on a product-by-product basis (i) the expiration date, (ii) our sales forecasts, and (iii) historical demand. Judgment is required in determining whether the forecasted sales information is sufficiently reliable to enable us to reasonably estimate inventory obsolescence. If actual future usage and demand for our products are less favorable than those projected by our management, additional inventory write-offs may be required in the future.
Intangible Assets
We have intangible assets related to purchased technology, goodwill and other acquired intangibles. The determination of related estimated useful lives and whether or not these assets are impaired involves significant judgment. Changes in strategy and/or market conditions could significantly impact these judgments and require adjustments to recorded asset balances. In accordance with SFAS 144, we review intangible assets, as well as other long-lived assets, for impairment whenever events or circumstances indicate that the carrying amount may not be fully recoverable. In accordance with SFAS 142, we review goodwill and other intangible assets with no definitive lives for impairment on an annual basis. Our fair value is compared to the carrying value of our net assets, including the intangible assets. If the fair value is greater than the carrying amount, then no impairment is indicated. To date, no impairment has been indicated.
Results of Operations
Three months ended March 31, 2004 compared to the three months ended March 31, 2003:
Total Revenues
| Three Months Ended | ||||||||||||||||
| March 31, |
||||||||||||||||
| Increase/ | % | |||||||||||||||
| 2004 |
2003 |
(Decrease) |
Change |
|||||||||||||
| (in $000s) | ||||||||||||||||
Net product sales |
$ | 5,148 | $ | 2,362 | $ | 2,786 | 118 | % | ||||||||
Technology, contract research, grant and royalty revenue |
| 259 | (259 | ) | | |||||||||||
Total revenues |
$ | 5,148 | $ | 2,621 | $ | 2,527 | 96 | % | ||||||||
Total revenues for the quarter ended March 31, 2004 increased $2,527,000, or 96%, from the quarter ended March 31, 2003 due to increases in net product sales.
Net product sales for the quarter ended March 31, 2004 increased by $2,786,000, or 118%, from the quarter ended March 31, 2003. The increase in net product sales is primarily the result of revenue from sales of Nascobal, which was introduced in July 2003, and also reflects higher net product sales of Acthar and Ethamolin in the period. Net product sales for the first quarter of 2004 were positively affected by seasonal demand for Ethamolin. We believe that Ethamolin sales will be significantly reduced in the remaining quarters of 2004. In addition, net product sales for the first quarter of 2004 include $325,000 of shipments to wholesalers at the beginning of the quarter for orders received in December 2003. We expect quarterly fluctuations in the net sales of all of our products due to the timing of shipments, seasonality of demand and the reallocation of promotional efforts for each product.
The lower net product sales of Acthar in the first quarter of 2003 on a comparative basis reflects the negative effect of our decision in the first quarter of 2003 to briefly discontinue normal wholesaler shipments of Acthar and to limit shipments to critical care and emergency care situations only, due to the relatively short dating of Acthar in our inventory and at the wholesale level. The increase in net product sales of Ethamolin in the first quarter of 2004 over the first quarter of 2003 was partially the result of lower shipments in the first quarter of 2003 resulting from the impact of the advanced buying by wholesalers of Ethamolin in mid-2002,