e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2005
OR
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|
o |
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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: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
(State or other jurisdiction
of incorporation or organization)
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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 þ No o
Indicate by check mark whether Registrant is an accelerated filer (as defined in Rule 12b-2 of
the Act). Yes o No þ
Indicate by check mark whether Registrant is a shell company
(as defined in Rule 12b-2 of the Act). Yes o No þ
At November 7, 2005 there were 52,880,502 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
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
|
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|
|
|
|
|
|
|
|
September 30, |
|
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December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
|
(Unaudited) |
|
|
(Note 1) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,341 |
|
|
$ |
8,729 |
|
Accounts receivable, net of allowances for doubtful accounts of $167 and $40 at
September 30, 2005 and December 31, 2004, respectively |
|
|
1,983 |
|
|
|
2,349 |
|
Inventories, net |
|
|
1,536 |
|
|
|
1,769 |
|
Prepaid expenses and other current assets |
|
|
1,341 |
|
|
|
839 |
|
Assets held for sale, net |
|
|
14,203 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
23,404 |
|
|
|
13,686 |
|
Property and equipment, net |
|
|
486 |
|
|
|
614 |
|
Purchased technology, net |
|
|
|
|
|
|
12,758 |
|
Goodwill |
|
|
299 |
|
|
|
299 |
|
Deposits and other assets |
|
|
731 |
|
|
|
816 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
24,920 |
|
|
$ |
28,173 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
837 |
|
|
$ |
1,103 |
|
Accrued compensation |
|
|
649 |
|
|
|
974 |
|
Sales-related reserves |
|
|
2,570 |
|
|
|
1,683 |
|
Other accrued liabilities |
|
|
495 |
|
|
|
598 |
|
Short-term debt and current portion of long-term debt and capital lease obligation |
|
|
692 |
|
|
|
349 |
|
Convertible debentures (face amount of $4,000), net of deemed discount of $103
at December 31, 2004 |
|
|
|
|
|
|
3,897 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
5,243 |
|
|
|
8,604 |
|
Long-term debt and long-term portion of capital lease obligation |
|
|
1,508 |
|
|
|
2,021 |
|
Other non-current liabilities |
|
|
914 |
|
|
|
886 |
|
Preferred stock, no par value, 7,500,000 shares authorized; 2,155,715 Series A shares
issued and outstanding at September 30, 2005 and December 31, 2004 (aggregate
liquidation preference of $10,000 at September 30, 2005 and December 31, 2004) |
|
|
5,081 |
|
|
|
5,081 |
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, no par value, 8,375 and 8,400 Series B shares issued and
outstanding at September 30, 2005 and December 31, 2004, respectively, net of
issuance costs (aggregate liquidation preference of $8,375 and $8,400 at
September 30, 2005 and December 31, 2004, respectively) |
|
|
7,553 |
|
|
|
7,578 |
|
Common stock, no par value, 105,000,000 shares authorized; 52,875,815 and
51,216,488 shares issued and outstanding at September 30, 2005 and December 31,
2004, respectively |
|
|
89,360 |
|
|
|
88,436 |
|
Deferred compensation |
|
|
(6 |
) |
|
|
(10 |
) |
Accumulated deficit |
|
|
(84,733 |
) |
|
|
(84,423 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
12,174 |
|
|
|
11,581 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
24,920 |
|
|
$ |
28,173 |
|
|
|
|
|
|
|
|
See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
3,558 |
|
|
$ |
3,869 |
|
|
$ |
12,346 |
|
|
$ |
13,107 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales (exclusive of amortization of purchased
technology) |
|
|
522 |
|
|
|
843 |
|
|
|
2,297 |
|
|
|
2,660 |
|
Selling, general and administrative |
|
|
2,298 |
|
|
|
3,415 |
|
|
|
7,140 |
|
|
|
8,958 |
|
Research and development |
|
|
536 |
|
|
|
522 |
|
|
|
1,597 |
|
|
|
1,521 |
|
Depreciation and amortization |
|
|
319 |
|
|
|
306 |
|
|
|
953 |
|
|
|
905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
3,675 |
|
|
|
5,086 |
|
|
|
11,987 |
|
|
|
14,044 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(117 |
) |
|
|
(1,217 |
) |
|
|
359 |
|
|
|
(937 |
) |
Non-cash amortization of deemed discount on convertible debentures |
|
|
|
|
|
|
(130 |
) |
|
|
(108 |
) |
|
|
(392 |
) |
Interest income |
|
|
29 |
|
|
|
24 |
|
|
|
87 |
|
|
|
48 |
|
Interest expense |
|
|
(38 |
) |
|
|
(118 |
) |
|
|
(247 |
) |
|
|
(282 |
) |
Other income, net |
|
|
5 |
|
|
|
5 |
|
|
|
6 |
|
|
|
8 |
|
Rental income, net |
|
|
67 |
|
|
|
70 |
|
|
|
181 |
|
|
|
212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(54 |
) |
|
|
(1,366 |
) |
|
|
278 |
|
|
|
(1,343 |
) |
Non-cash deemed dividend related to beneficial conversion feature of
Series B Preferred Stock |
|
|
|
|
|
|
|
|
|
|
84 |
|
|
|
|
|
Dividends on Series B Preferred Stock |
|
|
168 |
|
|
|
168 |
|
|
|
504 |
|
|
|
508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders |
|
$ |
(222 |
) |
|
$ |
(1,534 |
) |
|
$ |
(310 |
) |
|
$ |
(1,851 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common shareholders |
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
applicable to common shareholders |
|
|
52,813 |
|
|
|
51,111 |
|
|
|
52,236 |
|
|
|
50,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
278 |
|
|
$ |
(1,343 |
) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
15 |
|
|
|
22 |
|
Amortization of deemed discount on convertible debentures |
|
|
108 |
|
|
|
392 |
|
Amortization of deferred compensation |
|
|
4 |
|
|
|
5 |
|
Depreciation and amortization |
|
|
953 |
|
|
|
905 |
|
Deferred rent expense |
|
|
28 |
|
|
|
31 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
366 |
|
|
|
394 |
|
Inventories |
|
|
(16 |
) |
|
|
(501 |
) |
Prepaid expenses and other current assets |
|
|
(335 |
) |
|
|
259 |
|
Accounts payable |
|
|
(266 |
) |
|
|
277 |
|
Accrued compensation |
|
|
(325 |
) |
|
|
633 |
|
Sales-related reserves |
|
|
887 |
|
|
|
508 |
|
Other accrued liabilities |
|
|
(103 |
) |
|
|
(57 |
) |
|
|
|
|
|
|
|
Net cash flows provided by operating activities |
|
|
1,594 |
|
|
|
1,525 |
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(22 |
) |
|
|
(205 |
) |
Purchase of short-term investments |
|
|
|
|
|
|
(999 |
) |
Acquisition of purchased technology |
|
|
(2,000 |
) |
|
|
|
|
Proceeds from sale of property and equipment |
|
|
1 |
|
|
|
1 |
|
(Increase) decrease in other assets |
|
|
80 |
|
|
|
(10 |
) |
|
|
|
|
|
|
|
Net cash flows used in investing activities |
|
|
(1,941 |
) |
|
|
(1,213 |
) |
|
|
|
|
|
|
|
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Issuance of common stock, net of issuance costs |
|
|
129 |
|
|
|
2,452 |
|
Long-term borrowings |
|
|
|
|
|
|
2,147 |
|
Short-term borrowings |
|
|
191 |
|
|
|
569 |
|
Repayment of short-term and long-term debt |
|
|
(361 |
) |
|
|
(452 |
) |
Redemption of convertible debentures |
|
|
(4,000 |
) |
|
|
|
|
Payment of Series B preferred stock dividends |
|
|
|
|
|
|
(504 |
) |
|
|
|
|
|
|
|
Net cash flows provided by (used in) financing activities |
|
|
(4,041 |
) |
|
|
4,212 |
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents |
|
|
(4,388 |
) |
|
|
4,524 |
|
Cash and cash equivalents at beginning of period |
|
|
8,729 |
|
|
|
3,220 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
4,341 |
|
|
$ |
7,744 |
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
247 |
|
|
$ |
283 |
|
|
|
|
|
|
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Deemed dividend related to beneficial conversion feature of Series B preferred stock |
|
$ |
84 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Common stock issued in lieu of quarterly cash dividends on Series B preferred stock |
|
$ |
672 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Common stock issued upon conversion of Series B preferred stock and accrued dividends
for Series B preferred stock |
|
$ |
24 |
|
|
$ |
704 |
|
|
|
|
|
|
|
|
Equipment acquired under capital lease |
|
$ |
|
|
|
$ |
44 |
|
|
|
|
|
|
|
|
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company that
focuses on developing and commercializing novel therapeutics for the treatment of neurological
disorders. The Company focuses on the treatment of diseases and disorders of the central nervous
system (CNS), which are served by a limited group of physicians such as neurologists. 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,
complement the Companys therapeutic focus on neurology and can be acquired at a reasonable
valuation relative to the Companys cost of capital. In addition, through corporate collaborations,
the Company intends to develop new medications focused on its target markets. During the three and
nine month periods ended September 30, 2005, the Company owned four products that are distributed
in the United States: H.P. 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®, a 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; and Glofil®-125,
an injectable agent that assesses how well the kidney is working by measuring glomerular filtration
rate, or kidney function. The Companys agreement to promote and sell VSL#3®, a patented probiotic
marketed as a dietary supplement to promote normal gastrointestinal function, expired in January
2005.
On October 17, 2005, the Company completed the sale of its non-core products Nascobal,
Ethamolin and Glofil-125 to QOL Medical LLC (QOL) for aggregate proceeds of $28.3 million.
Further details on this transaction are provided in Note 15 Sale of Nascobal, Ethamolin, and
Glofil-125 and in the accompanying Managements Discussion and Analysis of Financial Condition and
Results of Operations.
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/A for the year ended December 31,
2004. The accompanying balance sheet at December 31, 2004 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, 2005. 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 No. 123), the Company has elected to follow Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to Employees (APBO No. 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 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 No. 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.
6
The following table illustrates the effect on net loss per share applicable to common
shareholders if the Company had applied the fair value recognition provisions of SFAS No. 123 to
stock-based employee compensation (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss applicable to common shareholders as reported |
|
$ |
(222 |
) |
|
$ |
(1,534 |
) |
|
$ |
(310 |
) |
|
$ |
(1,851 |
) |
Add: Stock-based employee compensation expense included in
reported net loss |
|
|
1 |
|
|
|
1 |
|
|
|
4 |
|
|
|
8 |
|
Deduct: Total stock-based employee compensation expense
determined under fair value method for all awards |
|
|
(113 |
) |
|
|
(168 |
) |
|
|
(341 |
) |
|
|
(510 |
) |
Add: Adjustment to stock-based employee compensation due to
forfeitures of unvested options, primarily related to CEO
resignation |
|
|
|
|
|
|
359 |
|
|
|
|
|
|
|
359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders, pro forma |
|
$ |
(334 |
) |
|
$ |
(1,342 |
) |
|
$ |
(647 |
) |
|
$ |
(1,994 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense for options granted to non-employees has been determined in accordance
with SFAS No. 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.
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123R,
Share-Based Payment, a revision to SFAS No. 123, Accounting for Stock-Based Compensation. SFAS
No. 123R eliminates the Companys ability to use the intrinsic value method of accounting under
APBO No. 25 and generally requires a public entity to reflect on its income statement, instead of
pro forma disclosures in its financial footnotes, the cost of employee services received in
exchange for an award of equity instruments based on the grant-date fair value of the award. The
grant-date fair value will be estimated using option-pricing models adjusted for the unique
characteristics of those equity instruments. SFAS No. 123R is effective generally for public
companies as of the beginning of the first interim or annual reporting period that begins after
December 15, 2005. SFAS No. 123R applies to all awards granted after the required effective date,
to awards that are unvested as of the effective date, and to awards modified, repurchased, or
cancelled after that date. As of the required effective date, all public entities that used the
fair-value-based method for either recognition or disclosure under the original SFAS No. 123 will
apply this revised statement. Under SFAS No. 123R, the Company must determine the appropriate fair
value model to be used for valuing share-based payments, the amortization method for compensation
cost and the transition method to be used at date of adoption. The transition methods include
modified prospective and modified retrospective adoption options. Under the modified prospective
method, compensation cost is recognized beginning with the effective date (a) based on the
requirements of SFAS No. 123R for all share-based payments granted after the effective date and (b)
based on the requirements of SFAS No. 123 for all awards granted to employees prior to the
effective date of SFAS No. 123R that remain unvested on the effective date. The modified
retrospective method includes the requirements of the modified prospective method described above,
but also permits entities to restate based on the amounts previously recognized under SFAS No. 123
for purposes of pro forma disclosures for all prior periods presented. The Company is currently
evaluating the requirements of SFAS No. 123R and will adopt this statement at the effective date.
The Company expects that the adoption of this statement may have a material effect on its financial
statements.
3. REVENUE RECOGNITION
Revenues from product sales are recognized based upon shipping terms, net of estimated
reserves for government chargebacks, Medicaid rebates, payment discounts, and returns for credit.
Revenue is recognized upon customer receipt of the shipment, provided the title to the product
transfers at the point of receipt by the customer. If the title to the product transfers at the
point of shipment, revenue is recognized upon shipment of the product.
The Company records estimated sales reserves against product revenues for government
chargebacks, Medicaid rebates, payment discounts and product returns for credit memoranda. The
Companys policy of issuing credit memoranda for expired product, which became effective for
product lots released after May 31, 2004, allows customers to return expired product for credit
within a six-month period after the expiration date. Customers who return expired product from
production lots released after May 31, 2004 will be issued credit memoranda equal to the sales
value of the product returned, and the estimated amount of such credit memoranda is
7
recorded as a liability with a corresponding reduction in gross product sales. This reserve
will be reduced as future credit memoranda are issued, with an offset to accounts receivable.
The Companys product exchange policy, which applies to product lots released prior to June 1,
2004, allows customers to return expired product for exchange within a six-month period after the
expiration date. Returns from these product lots 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 inspection prior to
acceptance. For Glofil-125 and VSL#3 the Company accepts no returns for expired product.
The Company records estimated sales reserves for expected product exchanges and credit
memoranda based upon historical return rates by product, analysis of return merchandise
authorizations, returns received, sales patterns, current inventory on hand at wholesalers, changes
in prescription demand, and other factors such as shelf life. The Company records estimated sales
reserves for Medicaid rebates and government chargebacks by analyzing historical rebate and
chargeback percentages, allowable Medicaid prices, and other factors, as required. Significant
judgment is inherent in the selection of assumptions and in the interpretation of historical
experience as well as the identification of external and internal factors affecting the estimate of
reserves for product returns, Medicaid rebates and government chargebacks. The Company routinely
assesses the historical returns and other experience including customers compliance with return
goods policy and adjusts its reserves as appropriate.
Reserves for government chargebacks, Medicaid rebates, product exchanges, and product returns
for credit memoranda were $2.6 million and $1.7 million at September 30, 2005 and December 31,
2004, respectively, and are classified as Sales-Related Reserves in the Consolidated Balance
Sheets. The reserves at September 30, 2005 include $2.0 million for estimated product returns for
credit memoranda on product lots of Acthar, Nascobal, and Ethamolin released and shipped after May
31, 2004.
In connection with the sale of Nascobal, Ethamolin and Glofil-125, the Company is responsible
for all Medicaid rebates and government chargebacks on sales of these products by the Company
through October 17, 2005. The Company is responsible for product returns on sales of these
products by the Company through October 17, 2005, but only to the extent of actual returns of these
products through January 31, 2006. Subsequent to October 17, 2005, the Company no longer has
access to Nascobal and Ethamolin product inventories to facilitate product replacements under the
Companys product replacement policy. As a result, credit will be provided on all returns of these
products through January 31, 2006. The difference between the amount of credit issued on the
divested products and the amounts accrued in the Companys product replacement and credit
memorandum reserves will be considered in the determination of the computed gain on the sale of the
divested products. As of September 30, 2005, the Company had product replacement and credit
memoranda returns reserves related to these products of $576,000.
The Company sells product to wholesalers, who in turn sell these products to pharmacies and
hospitals. In the case of VSL#3, the Company sold directly to consumers. The Company does not
require collateral from its customers.
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 $4.3
million and $8.7 million at September 30, 2005 and December 31, 2004, respectively. All cash
equivalents are in money market funds and commercial paper. The fair value of the funds
approximated cost.
As described in Note 15 Sale of Nascobal, Ethamolin, and Glofil-125, the Company estimates
net cash proceeds of $22.2 million from the sale of the Companys non-core products.
8
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Raw materials |
|
$ |
1,161 |
|
|
$ |
1,239 |
|
Work in process |
|
|
|
|
|
|
228 |
|
Finished goods |
|
|
422 |
|
|
|
409 |
|
Less allowance for excess and obsolete inventories |
|
|
(47 |
) |
|
|
(107 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,536 |
|
|
$ |
1,769 |
|
|
|
|
|
|
|
|
The Company has included the net book value of inventories of Nascobal, Ethamolin and
Glofil-125 as of September 30, 2005 totaling $249,000 in assets held for sale on the accompanying
Consolidated Balance Sheet. As described in Note 15 Sale of Nascobal, Ethamolin, and Glofil-125,
the Company sold these products on October 17, 2005. All product inventories were included in the
purchase price for these products.
6. INTANGIBLE ASSETS
Goodwill no longer subject to amortization amounted to $299,000 at September 30, 2005 and
December 31, 2004. The Company performed an impairment test of goodwill (including assembled
workforce) during the quarter ended December 31, 2004, which resulted in an impairment charge of
$180,000 related to the assembled workforce. The Company will continue to monitor the carrying
value of the remaining goodwill through the annual impairment tests or more frequently if
indicators of potential impairment exist. As of September 30, 2005, no indicators of potential
impairment existed.
The Company has included the net book value of the intangible asset purchased technology as of
September 30, 2005 totaling $14.0 million in assets held for sale on the accompanying Consolidated
Balance Sheet. Purchased technology at September 30, 2005 includes the $14.2 million cost to
acquire Nascobal in June 2003 and the $2.0 million paid by the Company in February 2005 related to
the transfer of the New Drug Application (NDA) for the Nascobal nasal spray from Nastech
Pharmaceutical Company Inc. (Nastech), less accumulated amortization of $2.2 million. The
Nascobal purchased technology was amortized over its estimated life of 15 years through September
30, 2005. As described in Note 15 Sale of Nascobal, Ethamolin, and Glofil-125, the Company sold
Nascobal on October 17, 2005, which will result in recording the net book value of the Nascobal
purchased technology as part of the gain on sale of the Companys non-core products.
7. CONVERTIBLE DEBENTURES
In March 2002, the Company issued $4.0 million of 8% convertible debentures to SF Capital
Partners Ltd. (SFCP), and Defiante Farmaceutica Lda (Defiante), a wholly-owned subsidiary of
Sigma-Tau Finanziaria SpA (Sigma-Tau), a significant shareholder and affiliate of the Company.
Sigma-Tau beneficially owned approximately 26% of the Companys outstanding common stock as of
September 30, 2005. The Company paid interest on the debentures at a rate of 8% per annum on a
quarterly basis. The debentures were convertible into 2,531,644 shares of the Companys common
stock at a fixed conversion price of $1.58 per share (subject to adjustment for stock splits and
reclassifications).
On March 8, 2005, the Company and Defiante entered into an amendment to the convertible
debenture issued by the Company in favor of Defiante, extending the maturity date to April 15,
2005. On March 10, 2005, the Company and SFCP entered into an amendment to the convertible
debenture issued by the Company in favor of SFCP, extending the maturity date to April 15, 2005 and
amending certain of the terms of the Companys option to repay the SFCP debenture in shares of
common stock at the maturity date.
On April 15, 2005, the Company redeemed both convertible debentures in full in cash totaling
$4.0 million, plus accrued interest to April 15, 2005.
9
8. SECURED PROMISSORY NOTE
In July 2004, the Company issued a $2.2 million secured promissory note to Defiante. The
interest rate on the note was 9.83% per annum. Repayment of the note consisted of interest only for
the first twelve months, with monthly principal and interest payments thereafter through August
2008. The note was secured by the Nascobal intellectual property including the NDA for the spray
formulation.
As described in Note 15 Sale of Nascobal, Ethamolin, and Glofil-125, the Company paid off
the total outstanding principal and accrued interest of $2.1 million on October 17, 2005 in
connection with the sale of Nascobal.
9. 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 September
30, 2005.
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.
10. NET INCOME (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Basic and diluted net loss per share applicable to common shareholders is based on net loss
applicable to common shareholders for the relevant period, divided by the weighted average number
of common shares outstanding during the period. Diluted net income per share applicable to common
shareholders would give effect to all potentially dilutive common shares outstanding during the
period such as options, warrants, convertible preferred stock, and contingently issuable shares.
Diluted net loss per share applicable to common shareholders has not been presented separately for
the periods ended September 30, 2005 and 2004 as, due to the Companys net loss position, it is
anti-dilutive. If the Company had net income per share applicable to common shareholders of $0.01
or greater for the three and nine month periods ended September 30, 2005, then shares used in
calculating diluted earnings per share applicable to common shareholders would have included, if
dilutive, the effect of the outstanding options to purchase 6,482,853 common shares, 11,053,930
convertible preferred shares, placement unit options for 127,679 common shares and warrants to
purchase 4,539,407 common shares.
11. EQUITY TRANSACTIONS
In April 2005, the Company issued 1,344,000 shares of common stock in a private placement to
holders of its Series B Preferred Stock. The shares were issued in lieu of the quarterly cash
dividends payable on April 1, 2005, July 1, 2005, October 1, 2005 and January 1, 2006, and had an
aggregate value equal to the dividends otherwise payable on those dates, with the shares of common
stock so issued valued at fair market value based upon a ten-day weighted average trading price
formula through March 29, 2005 (See Note 12 Series B Convertible Preferred Stock).
In July 2005, shares of the Companys Series B Preferred Stock with a stated value of $25,000,
less prepaid dividends of $1,400, were converted into 25,027 shares of common stock.
12. 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 $10.0 million. Net of issuance costs, the proceeds to the Company
were $9.4 million. Of the original $10.0 million stated value, Series B Convertible Preferred Stock
having a stated value of $1.6 million has been converted into common stock, resulting in a stated
value of $8.4 million for Series B Convertible Preferred Stock as of September 30, 2005.
10
According to the terms of the private placement agreement, each holder of Series B Convertible
Preferred Stock is entitled to a quarterly dividend at an initial rate of 8% per year, which will
increase to 10% per year on and after January 1, 2006, and to 12% on and after January 1, 2008. The
dividends are paid in cash on a quarterly basis. In addition, on the occurrence of designated
events, including the failure to maintain Net Cash, Cash Equivalent and Eligible Investment
Balances, as defined in the Companys Certificate of Determination of Series B Preferred Stock (the
Certificate of Determination), of at least 50% of the aggregate stated value of the outstanding
shares of Series B Preferred Stock, the dividend rate will increase by an additional 6% per year.
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
$0.9412, as adjusted by agreement dated June 13, 2003, per share, subject to certain anti-dilution
adjustments. The expiration date of the warrants was January 15, 2007. In January 2004 warrants to
purchase 373,990 shares of common stock were surrendered as consideration, along with cash, for the
issuance of 373,990 shares of common stock.
In March 2005, the Company and all of the holders of the outstanding shares of Series B
Preferred Stock of the Company entered into a Series B Preferred Shareholder Agreement and Waiver.
Pursuant to such agreement (i) the holders waived certain rights to receive additional dividends
through March 31, 2006, (ii) the holders, with respect to dividends payable on April 1, 2005, July
1, 2005, October 1, 2005 and January 1, 2006, accepted as full and complete payment of all such
dividend payments the issuance by the Company to them in a private placement of shares of the
Companys common stock having an aggregate value equal to the dividends otherwise payable on those
dates, with the shares of common stock so issued valued at fair market value based upon a ten-day
weighted average trading price formula through March 29, 2005, and (iii) the expiration date of the
warrants to purchase shares of the Companys common stock held by the holders was extended for one
year, until January 15, 2008.
As a result of the extension of the warrant expiration date, the Company revalued the warrants
issued to the Series B Preferred Stockholders, resulting in an incremental value of $84,000 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 3.9%; an
expiration date of January 15, 2008; volatility of 59% and a dividend yield of 0%. In connection
with the revaluation, in March 2005 the Company recorded $84,000 related to the beneficial
conversion feature on the Series B Preferred Stock as an additional deemed dividend, which
increased the carrying value of the Series B Preferred Stock. For the nine months ended September
30, 2005, the deemed dividend increased the net loss applicable to common shareholders in the
calculation of basic and diluted net loss per common share.
In July 2005, shares of the Companys Series B Preferred Stock with a stated value of $25,000,
less prepaid stock dividends of $1,400, were converted into 25,027 shares of common stock.
13. RELATED PARTY TRANSACTIONS
In December 2001, the Company entered into a promotion agreement with VSL Pharmaceuticals
Inc., and its successor, Sigma-Tau Pharmaceuticals Inc. (Sigma-Tau Pharmaceuticals), a private
company owned in part by the major shareholders of Sigma-Tau. The promotion agreement expired in
January 2005, in accordance with its terms. Under these agreements, the Company agreed to purchase
VSL#3 from Sigma-Tau Pharmaceuticals at a stated price, and also agreed to promote, sell, warehouse
and distribute the VSL#3 product directly to customers at its cost and expense, subject to certain
expense reimbursements. The Company did not accept returns of VSL#3. There was no VSL#3 revenue for
the quarter ended September 30, 2005, as the agreement expired in January 2005, and minimal revenue
for the nine month period ended September 30, 2005. An access fee to Sigma-Tau Pharmaceuticals was
calculated quarterly, which varied based upon sales and costs incurred by the Company subject to
reimbursement under certain circumstances and is included in selling, general and administrative
expense in the accompanying Consolidated Statements of Operations. The Company recorded a cost
reimbursement of $44,000 in the nine months ended September 30, 2005, which reduced selling,
general and administrative expense. The Company recorded an expense of $258,000 related to the
VSL#3 access fee in the nine months ended September 30, 2004. During the nine months ended
September 30, 2005 and 2004, the Company paid $79,000 and $379,000, respectively, to Sigma-Tau
Pharmaceuticals for the purchase of VSL#3 product.
14. COMPREHENSIVE INCOME (LOSS)
For the three and nine month periods ended September 30, 2005 and 2004, net loss was the same
as comprehensive loss.
11
15. SALE OF NASCOBAL, ETHAMOLIN AND GLOFIL-125
On October 17, 2005 (the Closing Date), the Company sold its Nascobal,
Ethamolin and Glofil-125 product lines (the Product
Lines) to QOL Medical LLC (QOL) pursuant
to an Asset Purchase Agreement (the Agreement) between the Company and QOL executed as of the
same date. Pursuant to the Agreement, QOL paid the Company an aggregate purchase price of $28.3
million and assumed the potential obligation to pay $2.0 million to Nastech upon the issuance by
the U.S. Patent and Trademark Office of a patent on Nascobal nasal spray. Of the $28.3
million aggregate proceeds from the transaction, $2.1 million was paid to Defiante, to satisfy in
full all amounts outstanding on the Closing Date under the promissory note issued by the Company on
July 31, 2004, in favor of Defiante. In addition, $2.0 million was paid to Nastech, the prior
owner of Nascobal, and the Companys supplier of Nascobal product, as an inducement for Nastech to
provide additional intellectual property and contractual rights to QOL and for Nastech to consent
to the assignment to QOL of its supply agreement and its asset purchase agreement with the Company.
After these payments, other transaction costs and expenses, and estimated federal and state income
taxes, the Companys net proceeds from the transaction are estimated to be approximately $22.2
million. The Company intends to use the net proceeds from the transaction to further its
previously announced strategy to focus on products that treat diseases and disorders of the central
nervous system, for working capital and for other general corporate purposes. The Company
estimates a net gain from the sale of the Product Lines of approximately $10.0 million. Pursuant
to the terms of the Agreement, the Company made certain representations and warranties concerning
the Product Lines and the Companys authority to enter into the Agreement and consummate the
transactions contemplated thereby. The Company also made certain covenants which survived the
Closing Date, including a covenant not to operate a business that competes, on a worldwide basis,
with the Product Lines for a period of six years from the Closing Date. In the event of a breach
of the representations, warranties or covenants made by the Company, QOL will have the right,
subject to certain limitations, to seek indemnification from the Company for any damages that it
has suffered as result of such breach.
The following Unaudited Pro Forma Condensed Consolidated Balance Sheet as of September 30,
2005 has been prepared as if the disposition of the Product Lines occurred on September 30, 2005.
The following Unaudited Pro Forma Condensed Consolidated Statement of Operations for the Nine
Months Ended September 30, 2005 has been prepared as if the disposition of the Product Lines
occurred on January 1, 2005. The unaudited pro forma financial information was prepared in
accordance with Article 11 of the United States Securities and Exchange Commission Regulation S-X.
The historical pro forma financial information as of September 30, 2005 and for the nine months
ended September 30, 2005 was derived from the financial statements included in this Quarterly
Report on Form 10-Q. The unaudited pro forma financial information should be read in conjunction
with this report. The unaudited pro forma financial information and the related notes are provided
for information purposes only and do not purport to be indicative of the results which would have
been obtained had the Product Lines been sold on the dates indicated or which may be expected to
occur in the future. The operating results of the Product Lines for the nine months ended
September 30, 2005 represent the revenues and directly related expenses only of the Product Lines
and do not purport to represent all the costs, expenses and results associated with a stand alone,
separate company. In accordance with Article 11 of Regulation S-X, the Unaudited Pro Forma
Condensed Consolidated Statements of Operations reflect only the pro forma impacts of the
disposition of the Product Lines to the Companys continuing operations and exclude the impact of
the estimated non-recurring gain and income taxes on the sale of the Product Lines. The estimated
gain and income taxes were considered in the determination of the pro forma accumulated deficit as
of September 30, 2005 as presented on the Unaudited Pro Forma Condensed Consolidated Balance Sheet
and further disclosed in note (F) of the Notes To Unaudited Pro forma Condensed Consolidated
Financial Statements.
12
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED BALANCE SHEET
AS OF SEPTEMBER 30, 2005
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma |
|
|
|
|
|
|
|
|
|
Historical |
|
|
Adjustments |
|
|
Notes |
|
|
Pro Forma |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,341 |
|
|
$ |
22,250 |
|
|
|
(A |
) |
|
$ |
26,591 |
|
Accounts receivable, net |
|
|
1,983 |
|
|
|
|
|
|
|
|
|
|
|
1,983 |
|
Inventories, net |
|
|
1,536 |
|
|
|
|
|
|
|
|
|
|
|
1,536 |
|
Prepaid expenses and other current assets |
|
|
1,341 |
|
|
|
|
|
|
|
|
|
|
|
1,341 |
|
Assets held for sale, net |
|
|
14,203 |
|
|
|
(14,203 |
) |
|
|
(B |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
23,404 |
|
|
|
8,047 |
|
|
|
|
|
|
|
31,451 |
|
Property and equipment, net |
|
|
486 |
|
|
|
|
|
|
|
|
|
|
|
486 |
|
Goodwill |
|
|
299 |
|
|
|
|
|
|
|
|
|
|
|
299 |
|
Deposits and other assets |
|
|
731 |
|
|
|
|
|
|
|
|
|
|
|
731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
24,920 |
|
|
$ |
8,047 |
|
|
|
|
|
|
$ |
32,967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
837 |
|
|
$ |
|
|
|
|
|
|
|
$ |
837 |
|
Accrued compensation |
|
|
649 |
|
|
|
|
|
|
|
|
|
|
|
649 |
|
Sales-related reserves |
|
|
2,570 |
|
|
|
500 |
|
|
|
(C |
) |
|
|
3,070 |
|
Other accrued liabilities |
|
|
495 |
|
|
|
23 |
|
|
|
(D |
) |
|
|
518 |
|
Short-term debt and current portion
of long-term debt and capital lease obligation |
|
|
692 |
|
|
|
(692 |
) |
|
|
(D |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
5,243 |
|
|
|
(169 |
) |
|
|
|
|
|
|
5,074 |
|
Long-term debt and long-term portion of capital lease obligation |
|
|
1,508 |
|
|
|
(1,508 |
) |
|
|
(E |
) |
|
|
|
|
Other non-current liabilities |
|
|
914 |
|
|
|
29 |
|
|
|
(E |
) |
|
|
943 |
|
Preferred stock, no par value, 7,500,000 shares authorized;
2,155,715 Series A shares issued and outstanding
(aggregate liquidation preference of $10,000) |
|
|
5,081 |
|
|
|
|
|
|
|
|
|
|
|
5,081 |
|
Shareholders equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, no par value, 8,375 Series B shares
issued and outstanding, net of issuance costs
(aggregate liquidation preference of $8,375) |
|
|
7,553 |
|
|
|
|
|
|
|
|
|
|
|
7,553 |
|
Common stock, no par value, 105,000,000 shares
authorized; 52,875,815 shares issued and outstanding |
|
|
89,360 |
|
|
|
|
|
|
|
|
|
|
|
89,360 |
|
Deferred compensation |
|
|
(6 |
) |
|
|
|
|
|
|
|
|
|
|
(6 |
) |
Accumulated deficit |
|
|
(84,733 |
) |
|
|
9,695 |
|
|
|
(F |
) |
|
|
(75,038 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
12,174 |
|
|
|
9,695 |
|
|
|
|
|
|
|
21,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
24,920 |
|
|
$ |
8,047 |
|
|
|
|
|
|
$ |
32,967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited pro forma condensed consolidated financial statements.
13
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2005
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma |
|
|
|
|
|
|
|
|
|
Historical |
|
|
Adjustments |
|
|
Notes |
|
|
Pro Forma |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
12,346 |
|
|
$ |
(5,299 |
) |
|
|
(G |
) |
|
$ |
7,047 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales (exclusive of amortization of purchased
technology) |
|
|
2,297 |
|
|
|
(785 |
) |
|
|
(H |
) |
|
|
1,512 |
|
Selling, general and administrative |
|
|
7,140 |
|
|
|
(112 |
) |
|
|
(I |
) |
|
|
7,028 |
|
Research and development |
|
|
1,597 |
|
|
|
(415 |
) |
|
|
(I |
) |
|
|
1,182 |
|
Depreciation and amortization |
|
|
953 |
|
|
|
(805 |
) |
|
|
(J |
) |
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
11,987 |
|
|
|
(2,117 |
) |
|
|
|
|
|
|
9,870 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
359 |
|
|
|
(3,182 |
) |
|
|
|
|
|
|
(2,823 |
) |
Non-cash amortization of deemed discount on convertible debentures |
|
|
(108 |
) |
|
|
|
|
|
|
|
|
|
|
(108 |
) |
Interest income |
|
|
87 |
|
|
|
582 |
|
|
|
(K |
) |
|
|
669 |
|
Interest expense |
|
|
(247 |
) |
|
|
144 |
|
|
|
(L |
) |
|
|
(103 |
) |
Other income, net |
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
6 |
|
Rental income, net |
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
278 |
|
|
|
(2,456 |
) |
|
|
|
|
|
|
(2,178 |
) |
Non-cash deemed dividend related to beneficial conversion feature of
Series B Preferred Stock |
|
|
84 |
|
|
|
|
|
|
|
|
|
|
|
84 |
|
Dividends on Series B Preferred Stock |
|
|
504 |
|
|
|
|
|
|
|
|
|
|
|
504 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders |
|
$ |
(310 |
) |
|
$ |
(2,456 |
) |
|
|
|
|
|
$ |
(2,766 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common shareholders |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
applicable to common shareholders |
|
|
52,236 |
|
|
|
52,236 |
|
|
|
|
|
|
|
52,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited pro forma condensed consolidated financial statements.
14
NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(A) The pro forma net cash adjustment totaled $22.2 million. This represented the aggregate
proceeds of $28.3 million from the sale of the Product Lines offset by the pay-off by the Company
of $2.2 million in outstanding debt as of September 30, 2005 that was collateralized by the
Nascobal product rights, a $2.0 million payment by the Company to Nastech related to the assumption
by QOL of the supply agreement to manufacture Nascobal, estimated deal related costs of $1.6
million, and estimated federal and state income taxes of $300,000.
(B) The Company classified the net book value of inventories of the Product Lines and Nascobal
purchased technology of $249,000 and $14.0 million, respectively, as assets held for sale as of
September 30, 2005. These assets were eliminated for pro forma purposes.
(C) In connection with the sale of the Product Lines, the Company is responsible for all Medicaid
rebates and government chargebacks on sales of the Product Lines by the Company through October 17,
2005. The Company is responsible for product returns on sales of the Product Lines by the Company
through October 17, 2005, but only to the extent of actual returns of the Product Lines through
January 31, 2006. Subsequent to October 17, 2005, the Company no longer has access to inventories
of the Product Lines to facilitate product replacements under the Companys product replacement
policy. As a result, credit will be provided on all returns of the Product Lines through January
31, 2006. As of September 30, 2005, the Company had product replacement and returns reserves
related to the Product Lines of $576,000. The Company estimates that the amount of credit issued on
the Product Lines will be approximately $500,000 greater than the amounts accrued in the Companys
product replacement and credit memorandum reserves.
(D) In connection with the sale of the rights to Nascobal, the Company paid-off the current and
long-term portions of the Companys $2.2 million outstanding debt as of September 30, 2005 that was
collateralized by the Nascobal product rights of which $669,000 was included in current liabilities
as of September 30, 2005. In addition, for pro forma purposes, the Company reclassified the
current portion of its other short-term debt and capital lease obligation of $23,000 to other
accrued liabilities.
(E) In connection with the sale of the rights to Nascobal, the Company paid-off the current and
long-term portions of the Companys $2.2 million outstanding debt as of September 30, 2005 that was
collateralized by the Nascobal product rights of which $1.5 million was classified as long-term
debt as of September 30, 2005. In addition, for pro forma purposes, the Company reclassified the
long-term portion of its other long-term debt and capital lease obligation of $29,000 to other
non-current liabilities.
(F) Accumulated deficit as of September 30, 2005 decreased for pro forma purposes by $9.7 million
resulting from an estimated $10.0 million pre-tax gain on the sale of the Product Lines, assuming
for pro forma purposes that the Product Lines were sold on September 30, 2005, less estimated
federal and state income taxes of $300,000. The pre-tax gain on the sale of the Product Lines
represented the aggregate proceeds of $28.3 million less the $2.0 million payment to the
manufacturer of Nascobal, net purchased technology of $14.0 million as of September 30, 2005, net
inventories of 249,000 as of September 30, 2005, the pro forma product returns reserve adjustment
of $500,000, and estimated deal related costs of $1.6 million. The estimated income taxes result
from the limitation of the use of the Companys net operating loss carry forwards when calculating
alternative minimum taxable income.
(G) The Company had net product sales of $5.3 million related to the Product Lines for the nine
months ended September 30, 2005 that was eliminated for pro forma purposes.
(H) The Company had cost of product sales of $785,000 related to the Product Lines for the nine
months ended September 30, 2005 that was eliminated for pro forma purposes.
(I) The Company had selling, general, and administrative expenses and research and development
costs directly related to the Product Lines of $527,000 during the nine months ended September 30,
2005 that were eliminated for pro forma purposes.
(J) The Company had product rights amortization of $805,000 related to the Product Lines for the
nine months ended September 30, 2005 that was eliminated for pro forma purposes.
(K) The Company recorded a pro forma adjustment to interest income of $582,000 for the nine months
ended September 30, 2005 assuming the transactions described herein and the Companys average risk
free interest rate of 2.8% for the nine months ended September 30, 2005.
15
(L) In connection with the sale of the rights to Nascobal, the Company paid-off the current and
long-term portions of the Companys $2.2 million outstanding debt as of September 30, 2005 that was
collateralized by the Nascobal product rights and eliminated interest expense related to this debt
of $144,000 for the nine months ended September 30, 2005.
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/A for the fiscal year ended December 31, 2004, 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 focuses on developing and commercializing novel
therapeutics for the treatment of neurological disorders. We focus on the treatment of diseases and
disorders of the central nervous system (CNS), which are served by a limited group of physicians
such as neurologists. 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, complement our therapeutic focus on neurology and can be acquired at a reasonable valuation
relative to our cost of capital. During the three and nine month periods ended September 30, 2005,
we owned and distributed four products in the United States:
|
|
|
H.P. 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, a 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; and |
|
|
|
|
Glofil-125, an injectable agent that assesses how well the kidney is working by
measuring glomerular filtration rate, or kidney function. |
In January 2005, our agreement to promote and sell VSL#3 expired in accordance with its terms.
Our strategy, which we announced in April 2005, is to focus on developing and commercializing
products that treat CNS diseases and disorders. As part of this strategy, we are initially focusing
our promotional efforts on Acthar, our neurological product. We also intend to pursue the licensing
and acquisition of products that are consistent with our focus on neurology. In addition, we intend
to develop new products that have the potential to address significant unmet medical needs in the
CNS field, using both our own intellectual property and intellectual property licensed from other
companies. In connection with this strategy, on October 17, 2005, we sold our non-core products
Nascobal, Ethamolin, and Glofil-125 for aggregate proceeds of $28.3 million. Further details
regarding the sale of these products are described in this Managements Discussion and Analysis of
Financial Condition and Results of Operations and in Note 15 Sale of Nascobal, Ethamolin, and
Glofil-125 of the accompanying Notes to Consolidated Financial Statements.
Consistent with our prior focus on sales and marketing, our spending on research and
development activities to date is modest. Expenses incurred for the Acthar manufacturing site
transfer and medical and regulatory affairs are classified as Research and Development Expenses in
the accompanying unaudited Consolidated Statements of Operations. We expect our research and
development spending to increase in the future as we implement our new strategy. 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
16
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 a
development agreement with Rigel Pharmaceuticals, Inc. of South San Francisco, California for our
antiviral drug discovery program, and a development agreement with Dainippon Pharmaceuticals Co.,
Ltd. of Osaka, Japan for our antibacterial program.
We have incurred an accumulated deficit of $84.7 million at September 30, 2005. At September
30, 2005, we had $4.3 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, prescription demand for our products, inventory levels of our products at wholesalers,
timing of expiration of our products, shipment of replacement product under our product exchange
policy, future credit memoranda to be issued under our credit memoranda policy, the availability of
finished goods from our sole-source manufacturers, the timing of certain expenses, the acquisition
of marketed products, and the establishment of strategic alliances and corporate partnering
arrangements.
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 sales reserves, product returns, bad debts, inventories 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 Reserves
We have estimated reserves for product returns from wholesalers, hospitals 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 reserves by utilizing
historical information for existing products and data obtained from external sources. For new
products, we estimate our reserves for product returns, government chargebacks and rebates on
specific terms for product returns, chargebacks and rebates, and our experience with similar
products.
Significant judgment is inherent in the selection of assumptions and the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimates of our reserves for product returns, government chargebacks, and Medicaid rebates. We
believe that the assumptions used to estimate these sales reserves are the most reasonably likely
assumptions considering known facts and circumstances. However, our product return activity,
government chargebacks received, and Medicaid rebates paid could differ significantly from our
estimates because our analysis of product shipments, prescription trends and the amount of product
in the distribution channel may not be accurate. If actual product returns, government chargebacks,
and Medicaid rebates are significantly different from our estimates, or if the wholesalers fail to
adhere to our exchange or credit memoranda policy, such differences would be accounted for in the
period in which they become known. To date, actual amounts have been consistent with our estimates.
We have a product exchange policy, effective for product lots released prior to June 1, 2004,
in which we ship replacement product for expired product returned to us within six months after
expiration. The estimated costs for such potential exchanges, which include actual product costs
and related shipping charges, are included in cost of product sales. A reserve for estimated
returns on shipments of product lots released and shipped prior to June 1, 2004 has been recorded
as a liability in the amount of $128,000 as of September 30, 2005. This reserve reflects an
estimate of future product replacements, applied to the quantity of product shipped from lots
subject to the product exchange policy. The reserve will be reduced as future product replacements
occur, with an offset to product inventories.
During the second quarter of 2004 we implemented a transition plan for expired product returns
from the product exchange policy to a credit memoranda policy for the return of expired product
within six months after the expiration date. Expired product returned
from lots released after May 31, 2004 is subject to a credit memoranda policy in which a
credit memoranda will be issued for the
17
original purchase price of the returned product. A reserve
for the sales value of estimated returns on shipments of product lots released and shipped after
May 31, 2004 has been recorded as a liability in the amount of $2.0 million as of September 30,
2005 with a corresponding reduction in gross product sales. This reserve reflects an estimate of
future credit memoranda to be issued, applied to the quantity of product shipped from lots subject
to the credit memoranda policy. The reserve will be reduced as future credit memoranda are issued,
with an offset to accounts receivable. Total sales-related reserves increased to $2.6 million at
September 30, 2005 from $1.7 million at December 31, 2004. The increase in total sales-related
reserves includes an increase of $899,000 for reserves recorded under our credit memoranda policy
in the first nine months of 2005.
In estimating returns for each product, we analyze (i) historical returns and sales patterns,
(ii) current inventory on hand at wholesalers and the remaining shelf life of that inventory
(ranging from 18 months to 3 years for all products except
Glofil-125, which is not subject to our
product return policy), and (iii) changes in demand measured by prescriptions or other data as
provided by an independent third party source and our internal estimates. We believe that the
information obtained from wholesalers regarding inventory levels and from independent third parties
regarding prescription demand is reliable, but we are unable to independently verify the accuracy
of such data. For Glofil-125, we accept no returns for expired product. We routinely assess our
historical experience including customers compliance with our product exchange policy, and we
adjust our reserves as appropriate.
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 estimated rebate reserve for the period. We also consider allowable
prices by Medicaid. In estimating government chargeback reserves, we analyze actual chargeback
amounts by product and apply historical chargeback rates to sales to which chargebacks apply. We
routinely assess our experience with Medicaid rebates and government chargebacks and adjust the
reserves accordingly.
For qualified customers, we grant payment terms of 2%, net 30 days. Allowances for cash
discounts are estimated based upon the amount of trade accounts receivable as of the period end
that are subject to the cash discounts.
In connection with the sale of Nascobal, Ethamolin and Glofil-125, we are responsible for all
Medicaid rebates and government chargebacks on our sales of these products through October 17,
2005. We are responsible for product returns on our sales of these products through October 17,
2005, but only to the extent of actual returns of these products through January 31, 2006.
Subsequent to October 17, 2005, we no longer have access to Nascobal and Ethamolin product
inventories to facilitate product replacements under our product replacement policy. As a result,
credit will be provided on all returns of these products through January 31, 2006. The difference
between the amount of credit issued on the divested products and the amounts accrued in our product
replacement and credit memorandum reserves will be considered in the determination of the computed
gain on the sale of the divested products. As of September 30, 2005, we had product replacement
and returns reserves related to these products of $576,000.
Inventories
We maintain inventory reserves primarily for excess and obsolete inventory (due to the
expiration of shelf life of a product). In estimating inventory excess and 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 excess and obsolete
inventory. 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.
We intend to control inventory levels of our products purchased by our customers. Customer
inventories may be compared to both internal and external databases to determine adequate inventory
levels. We may monitor our product shipments to customers and compare these shipments against
prescription demand for our individual products.
Intangible Assets
As of September 30, 2005, we have intangible assets related to purchased technology and
goodwill. The determination of related estimated useful lives and whether or not these assets are
impaired involves significant judgment. Changes in strategy or market conditions could
significantly impact these judgments and require adjustments to recorded asset balances. In
accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, 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 No. 142, Goodwill and Other Intangible Assets, 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
18
intangible assets. If the fair value is greater than the
carrying amount, then no impairment is indicated. As of September 30, 2005, no impairment has been
indicated.
Results of Operations
Three months ended September 30, 2005 compared to the three months ended September 30, 2004:
Total Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Net product sales |
|
$ |
3,558 |
|
|
$ |
3,869 |
|
|
$ |
(311 |
) |
|
|
(8 |
)% |
Total revenues for the quarter ended September 30, 2005, which consisted of net product sales
only, decreased $311,000, or 8%, from the quarter ended September 30, 2004. Third quarter 2004 net
product sales included $372,000 in net product sales of VSL#3. There were no VSL#3 net product
sales for the third quarter of 2005, as our promotion agreement with Sigma-Tau Pharmaceuticals
expired in January 2005. Third quarter 2005 net product sales of Acthar were $2.0 million, which
increased $39,000, or 2%, as compared to net product sales in the third quarter of 2004. The
increase in net product sales of Acthar consisted of a 16% increase in average selling price
offset by a 14% decline in units sold. Net product sales for the three months ended September 30,
2005 included $1.6 million of net product sales related to the divested products.
We review the amount of inventory of our products at the wholesale level in order to help
assess the demand for our products. We may choose to defer sales in situations where we believe
inventory levels are already adequate. We expect quarterly fluctuations in net product sales due to
the timing of shipments, changes in wholesaler inventory levels, expiration dates of products sold,
the timing of replacement units shipped under our product exchange policy, the impact of reserves
provided for under our credit memoranda policy and the allocation of promotional efforts.
Cost of Product Sales
Cost of product sales for the quarter ended September 30, 2005 decreased $321,000, or 38%, to
$522,000 from $843,000 for the quarter ended September 30, 2004. Cost of product sales as a
percentage of net product sales was 14.7% for the quarter ended September 30, 2005, as compared to
21.8% for the quarter ended September 30, 2004. Cost of product sales includes material cost,
packaging, warehousing and distribution, product liability insurance, royalties, quality control,
quality assurance and write-offs of excess or obsolete inventory. The decrease in cost of product
sales and our improvement in product margin is primarily due to a decrease in (a) material,
shipping and other costs of $183,000 resulting from the expiration of the VSL#3 promotion agreement
with Sigma-Tau Pharmaceuticals in January 2005, (b) product replacement costs of $62,000 resulting
from product shipments in the third quarter of 2005 that were subject to our credit memoranda
return policy, rather than our product replacement policy, (c) Acthar royalties of $67,000
resulting from the inclusion of our credit memo returns reserves as an offset in computing net
sales subject to royalties, and (d) distribution costs of $38,000 resulting from a contractual
offset to our third quarter 2005 distribution fees due to one of our wholesalers. We expect per
unit material costs for Acthar to increase in the future due to higher contract manufacturing and
laboratory costs, which we anticipate could decrease our gross margin on Acthar. Cost of product
sales for the three months ended September 30, 2005 included $223,000 of direct product costs
related to the divested products.
19
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
2,298 |
|
|
$ |
3,415 |
|
|
$ |
(1,117 |
) |
|
|
(33 |
)% |
Selling, general and administrative expenses for the quarter ended September 30, 2005
decreased $1.1 million from the quarter ended September 30, 2004. The decrease was primarily due to
$920,000 in severance-related charges in the third quarter of 2004 associated with the departure of
our former Chief Executive Officer, lower salaries and related expenses in 2005 resulting from
personnel changes and the realignment of the sales force, and a $145,000 reduction in access fees
and other direct operating costs related to the promotion of VSL#3 resulting from the expiration of
the promotion agreement with Sigma-Tau Pharmaceuticals in January 2005. The decreases were
partially offset by higher professional fees as compared to the quarter ended September 30, 2004.
Research and Development
Research and development expenses for the quarter ended September 30, 2005 were $536,000, an
increase of $14,000 as compared to $522,000 for the quarter ended September 30, 2004. The costs
included in research and development relate primarily to our medical and regulatory affairs
compliance activities and manufacturing site transfers. Research and development expenses for the
three months ended September 30, 2005 included $138,000 of direct expenses related to the divested
products.
In 2003, we transferred the Acthar final fill and packaging process to our contract
manufacturer, Chesapeake Biological Laboratories Inc. (CBL), and produced our first lot of Acthar
finished vials. In 2004, we transferred the Acthar active pharmaceutical ingredient (API)
manufacturing process to our contract manufacturer, BioVectra dcl (BioVectra), and produced the
first BioVectra API lot. We also selected a new contract laboratory to perform three bioassays
associated with the release of API and finished vials. Two of these bioassays have been
successfully transferred to the contract laboratory and were approved by the FDA in June 2005. We
have experienced delays and cost overruns in the validation of the third assay, potency. In 2004,
we conducted additional studies aimed at identifying critical differences in the way the potency
assay is performed at the contract laboratory as compared with the previous laboratory. Some
differences were identified and corrected, however, results were still not acceptable. Work on this
assay transfer was restarted in the second quarter of 2005. Our former contract manufacturer has
agreed to perform any potency assays we require through 2006. In the remainder of fiscal year 2005,
the costs which we plan to incur related to the API manufacturing site transfer and the bioassay
transfers are expected to be less than the costs incurred in 2004.
Depreciation and Amortization
Depreciation and amortization expense for the quarter ended September 30, 2005 increased to
$319,000 from $306,000 for the quarter ended September 30, 2004. This increase was due primarily to
the amortization of the $2.0 million we paid to Nastech in February of 2005 upon the approval of
the NDA for Nascobal nasal spray. The Nascobal purchased technology is being amortized over 15
years. Depreciation and amortization expense for the three months ended September 30, 2005
included $277,000 of amortization expense related to the divested products.
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
September 30, |
|
Increase/ |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
|
(in $000s) |
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
|
|
|
$ |
(130 |
) |
|
$ |
130 |
|
Interest income |
|
|
29 |
|
|
|
24 |
|
|
|
5 |
|
Interest expense |
|
|
(38 |
) |
|
|
(118 |
) |
|
|
80 |
|
Other income |
|
|
5 |
|
|
|
5 |
|
|
|
|
|
Rental income, net |
|
|
67 |
|
|
|
70 |
|
|
|
(3 |
) |
We did not record any non-cash amortization of deemed discount on convertible debentures for
the quarter ended September 30, 2005 as compared to $130,000 for the quarter ended September 30,
2004. The deemed discount was fully amortized as of March 15,
20
2005 when the convertible debentures were scheduled to mature. The convertible debentures were
issued in March 2002. In March 2005, the maturity date of the convertible debentures was extended
to April 15, 2005, on which date we redeemed such convertible debentures in full in cash.
Interest income for the quarter ended September 30, 2005 increased by $5,000 from the quarter
ended September 30, 2004. The increase was primarily due to higher interest rates in the third
quarter of 2005 compared to the same period in 2004. Interest expense for the quarter ended
September 30, 2005 decreased by $80,000 from the quarter ended September 30, 2004. The decrease was
due to the redemption of our convertible debentures in April 2005. Interest expense for the three
months ended September 30, 2005 consists of interest expense on the $2.2 million promissory note we
issued to a wholly-owned subsidiary of Sigma-Tau, Defiante Farmaceutica Lda, in July 2004. The
promissory note was paid off on October 17, 2005 in connection with the sale of our non-core
products.
Rental income, net, for the quarter ended September 30, 2005 decreased by $3,000 from the
quarter ended September 30, 2004. Rental income, net, arises primarily from the lease and sublease
of our former headquarters facility in Hayward, California. We have been notified by our tenant
that they will be vacating the Hayward facility on July 31, 2006. We are beginning the process to
search for a new tenant. We are obligated to pay rent on this facility of $6.0 million through
2012.
Series B Preferred Stock Dividends
Preferred Stock dividends of $168,000 for each of the quarters ended September 30, 2005 and
2004 represent the 8% dividend paid quarterly to our Series B Preferred Stockholders. The dividend
for the quarters ended September 30, 2005 and 2004 were paid in common stock and cash,
respectively. In March 2005, we reached agreement with all of the holders of the outstanding shares
of our Series B Preferred Stock to accept a private placement of shares of our common stock having
an aggregate value equal to the dividends payable on April 1, 2005, July 1, 2005, October 1, 2005
and January 1, 2006. The dividend rate increases to 10% on January 1, 2006.
Nine months ended September 30, 2005 compared to the nine months ended September 30, 2004:
Total Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Net product sales |
|
$ |
12,346 |
|
|
$ |
13,107 |
|
|
$ |
(761 |
) |
|
|
(6 |
)% |
Total revenues for the nine months ended September 30, 2005, which consisted of net product
sales only, decreased $761,000, or 6%, from the nine months ended September 30, 2004. Net product
sales for the nine months ended September 30, 2004 included $1.1 million in net product sales of
VSL#3. Net product sales of VSL#3 were $71,000 during the nine months ended September 30, 2005, as
our promotion agreement with Sigma-Tau Pharmaceuticals expired in January 2005. Net product sales
of Acthar during the nine months ended September 30, 2005 were $7.0 million, which increased $1.8
million, or 35%, as compared to net product sales in the same period of 2004. The increase in net
product sales of Acthar consisted of a 15% increase in average selling price and a 25% increase in
units sold offset by an increase in Acthar sales reserves to 21% of gross sales during the nine
months ended September 30, 2005 from 16% for the same period in 2004. The increase in Acthar sales
reserves as a percent of gross sales was due to an increase in the credit memo returns reserve as
lots of Acthar transitioned from our product replacement policy and an increase in the Acthar
Medicaid rebate reserve resulting from our price increases in 2005. Net product sales for the nine
months ended September 30, 2005 included $5.3 million of net product sales related to the divested
products.
Cost of Product Sales
Cost of product sales for the nine months ended September 30, 2005 decreased $363,000, or 14%,
to $2.3 million from $2.7 million for the nine months ended September 30, 2004. Cost of product
sales as a percentage of net product sales was 19% for the nine months ended September 30, 2005 as
compared to 20% for the same period in 2004. The decrease in cost of product sales and our
improved product margin was primarily due to decreases in direct material and shipping related
costs of approximately $463,000 as a result of the expiration of the VSL#3 promotion agreement with
Sigma-Tau Pharmaceuticals in January 2005 and product replacement costs of $87,000 resulting from
product shipments during the nine months ended September 30, 2005 that were subject to our credit
memoranda return policy, rather than our product replacement policy, offset by an increase of
$240,000 for routine product
21
quality control and assurance activities, primarily related to Acthar. We expect per unit
material costs for Acthar to increase in the future due to higher contract manufacturing and
laboratory costs, which we anticipate could decrease our gross margin on Acthar. Cost of product
sales for the nine months ended September 30, 2005 included $785,000 of direct product costs
related to the divested products.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
7,140 |
|
|
$ |
8,958 |
|
|
$ |
(1,818 |
) |
|
|
(20 |
)% |
Selling, general and administrative expenses for the nine months ended September 30, 2005
decreased $1.8 million from the nine months ended September 30, 2004. The decrease was primarily
due to $920,000 in severance-related charges in the third quarter of 2004 associated with the
departure of our former Chief Executive Officer, lower salaries and related expenses in 2005
resulting from personnel changes and the realignment of our sales force, and a $512,000 reduction
in access fees and other direct operating costs related to the promotion of VSL#3 resulting from
the expiration of the promotion agreement with Sigma-Tau Pharmaceuticals in January 2005. Selling,
general and administrative expenses for the nine months ended September 30, 2005 included $112,000
of direct expenses related to the divested products.
Research and Development
Research and development expenses for the nine months ended September 30, 2005 were $1.6
million, an increase of $76,000 as compared to $1.5 million for the nine months ended September 30,
2004. The increase as compared to the same period in 2004 was due primarily to increased regulatory
fees, patent-related legal fees and consulting costs, offset by decreased Acthar manufacturing site
transfer costs. Research and development expenses for the nine months ended September 30, 2005
included $415,000 of direct expenses related to the divested products.
Depreciation and Amortization
Depreciation and amortization expense for the nine months ended September 30, 2005 increased
to $953,000 from $905,000 for the nine months ended September 30, 2004, primarily due to the
amortization of the $2.0 million we paid to Nastech in February of 2005 upon the approval of the
NDA for Nascobal nasal spray. The Nascobal purchased technology is being amortized over 15 years.
Depreciation and amortization expense for the nine months ended September 30, 2005 included
$805,000 of amortization expense related to the divested products.
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
September 30, |
|
Increase/ |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
|
(in $000s) |
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
(108 |
) |
|
$ |
(392 |
) |
|
$ |
284 |
|
Interest income |
|
|
87 |
|
|
|
48 |
|
|
|
39 |
|
Interest expense |
|
|
(247 |
) |
|
|
(282 |
) |
|
|
35 |
|
Other income |
|
|
6 |
|
|
|
8 |
|
|
|
(2 |
) |
Rental income, net |
|
|
181 |
|
|
|
212 |
|
|
|
(31 |
) |
Non-cash amortization of deemed discount on convertible debentures for the nine months ended
September 30, 2005 decreased by $284,000 from the nine months ended September 30, 2004, due to the
deemed discount being fully amortized as of March 15, 2005, when the convertible debentures were
scheduled to mature. In March 2005, the maturity date of the convertible debentures was extended to
April 15, 2005, on which date we redeemed such convertible debentures in full in cash.
Interest income for the nine months ended September 30, 2005 increased by $39,000 from the
nine months ended September 30, 2004. The increase was primarily due to higher cash balances during
the first quarter of 2005 and higher interest rates in the nine
22
months ended September 30, 2005. Interest expense for the nine months ended September 30, 2005
decreased by $35,000 from the nine months ended September 30, 2004. Interest expense consists
primarily of interest on our convertible debentures and on the $2.2 million promissory note we
issued to a wholly-owned subsidiary of Sigma-Tau, Defiante Farmaceutica Lda, in July 2004. The
decrease was primarily due the decrease in interest expense on the convertible debentures redeemed
in April 2005, partially offset by an additional six months of interest in 2005 on the $2.2 million
promissory note. We paid-off the outstanding balance of the promissory note on October 17, 2005 in
connection with the sale of our non-core products. Interest expense for the nine months ended
September 30, 2005 included $144,000 of interest on the promissory note that was paid off on
October 17, 2005.
Rental income, net, for the nine months ended September 30, 2005 decreased by $31,000 from the
nine months ended September 30, 2004. The decrease in rental income, net, relates primarily to a
sublease that was not renewed on our building in Carlsbad, California. Rental income, net, arises
primarily from the lease and sublease of our former headquarters facility in Hayward, California.
We have been notified by our tenant that they will be vacating the Hayward facility on July 31,
2006. We are beginning the process to search for a new tenant. We are obligated to pay rent on
this facility of $6.0 million through 2012.
Series B Preferred Stock Dividends
Preferred Stock dividends of $504,000 and $508,000 for the nine months ended September 30,
2005 and 2004, respectively, represent the 8% dividends paid quarterly to our Series B Preferred
Stockholders. The dividends for the nine months ended September 30, 2005 and 2004 were paid in
common stock and cash, respectively. The dividend rate increases to 10% on January 1, 2006.
The non-cash deemed dividend of $84,000 for the nine months ended September 30, 2005 is
related to the revaluation of the warrants issued to the Series B Preferred Stockholders, which
resulted in an incremental value of $84,000 that decreased the carrying value of the preferred
stock. In connection with the revaluation, the Company recorded $84,000 related to the beneficial
conversion feature on the Series B Preferred Stock as an additional deemed dividend, which
increased the carrying value of the Series B Preferred Stock. For the nine months ended September
30, 2005, the deemed dividend increased the net loss applicable to common shareholders in the
calculation of basic and diluted net loss per common share.
Liquidity and Capital Resources
We have funded our activities to date principally through various issuances of equity
securities and debt. We have also funded our activities to date to a lesser extent through product
sales. In addition, we expect to generate net cash proceeds of approximately $22.2 million from
the sale of our non-core products.
At September 30, 2005, we had cash and cash equivalents of $4.3 million compared to $8.7
million at December 31, 2004. The decrease in our cash balance is due primarily to the redemption
of our convertible debentures in cash totaling $4.0 million in April 2005. At September 30, 2005,
our working capital was $18.2 million compared to $5.1 million at December 31, 2004. The increase
in our working capital was principally due to the classification of $14.0 million of net purchased
technology as of September 30, 2005 within assets held for sale, which represents the purchased
technology associated with our Nascobal product that we sold in October 2005. This increase was
offset by the $2.0 million payment we made to Nastech upon approval of the NDA for the Nascobal
spray in February 2005.
As of March 31, 2005, we had 8% convertible debentures with a face value of $4.0 million
outstanding, $2.0 million issued to Defiante, and $2.0 million issued to SF Capital Partners Ltd.
(SFCP), an institutional investor. Under the original terms of the debentures, we could redeem
SFCPs debenture at maturity for stock, subject to certain limitations, and we could redeem
Defiantes debenture for stock at maturity, provided the market price of our common stock at the
time of redemption was greater than $1.50 per share (representing the five day average closing sale
price of our common stock immediately prior to March 15, 2002). If the price of our common stock
was not greater than $1.50 per share on March 15, 2005, we would have been required to pay $2.0
million in cash to Defiante to redeem the convertible debenture.
The original maturity date of the debentures was March 15, 2005. On March 8, 2005, we entered
into an amendment to the debenture with Defiante, extending the maturity date to April 15, 2005. On
March 10, 2005, we entered into an amendment to the debenture with SFCP, extending the maturity
date to April 15, 2005 and amending certain of the terms of our option to repay the SFCP debenture
in shares of common stock at the maturity date. On April 15, 2005, we redeemed both convertible
debentures in cash totaling $4.0 million, plus accrued interest.
23
In connection with our acquisition of Nascobal, we also agreed to acquire the rights to
Nascobal nasal spray, an alternative dosage form of Vitamin B-12. In February 2005, upon approval
by the FDA of an NDA filed by Nastech in December 2003 for Nascobal nasal spray, Nastech was
obligated to transfer the NDA to us, and we were obligated to pay $2.0 million to Nastech. We made
the $2.0 million payment to Nastech in February 2005.
In July 2004, we issued a $2.2 million secured promissory note to Defiante. We paid this note
off on October 17, 2005 in connection with the sale of our non-core products. The note was secured
by the Nascobal intellectual property including the NDA for the spray formulation. The note,
bearing interest at 9.83% per annum, required interest only payments for the first twelve months,
with monthly principal and interest payments thereafter through August 2008.
In August 2004, Mr. Charles J. Casamento resigned as Chairman, President and CEO of the
Company. Under the separation agreement entered into by us and Mr. Casamento, and consistent with
certain terms of his employment agreement, we (i) will continue to pay Mr. Casamento his regular
monthly base salary of $38,208 for 18 months, (ii) paid the prorated portion of his 2004 annual
bonus potential in the amount of $136,294 in August 2004, and (iii) extended the exercise period
for 18 months of 129,251 stock options with an exercise price of $1.25 per share. All other stock
options held by Mr. Casamento expired on November 3, 2004. Although certain payments are being paid
on a monthly basis over the 18 months, Mr. Casamento will not be performing further services for
us, other than part-time consulting services, if requested by the Company.
In January 2003, we completed a private placement of Series B Convertible Preferred Stock and
warrants to purchase common stock to various healthcare investors. Our gross proceeds from the
private placement were $10.0 million. Net of issuance costs, our proceeds were $9.4 million. The
Series B Preferred Stock had an aggregate stated value at the time of issuance of $10.0 million and
is entitled to a quarterly dividend at an initial rate of 8% per year, which will increase to 10%
per year on and after January 1, 2006, and to 12% on and after January 1, 2008. The dividends are
paid in cash on a quarterly basis. In addition, on the occurrence of designated events the dividend
rate will increase by an additional 6% per year.
On March 29, 2005, we entered into a Series B Preferred Shareholder Agreement and Waiver with
all of the holders of the outstanding shares of our Series B Preferred Stock. Pursuant to such
agreement (i) the holders waived certain rights to receive additional dividends through March 31,
2006, (ii) the holders, with respect to dividends payable on April 1, 2005, July 1, 2005, October
1, 2005 and January 1, 2006, accepted as full and complete payment of all such dividend payments
the issuance by us to them in a private placement of shares of our common stock having an aggregate
value equal to the dividends otherwise payable on those dates, with the shares of common stock so
issued valued at fair market value based upon a ten-day weighted average trading price formula
through March 29, 2005, and (iii) the expiration date of the warrants to purchase shares of our
common stock held by the holders was extended for one year, until January 15, 2008. Accordingly, on
April 1, 2005, we issued 1,344,000 shares of common stock in a private placement to holders of our
Series B Convertible Preferred Stock.
The Series B Preferred Stock is entitled to a liquidation preference over our common stock and
Series A Preferred Stock upon a liquidation, dissolution or winding up of Questcor. The Series B
Preferred Stock is convertible at the option of the holder into our common stock at a conversion
price of $0.9412 per share, subject to certain anti-dilution adjustments. To date, Series B
Preferred Stock having a stated value of $1.6 million and accrued and unpaid dividends, net of
prepaid dividends, of $16,000 have been converted into 1,749,939 shares of common stock. We have
the right commencing on January 1, 2006 (assuming specified conditions are met) to redeem the
Series B Preferred Stock at a price of 110% of stated value, together with all accrued and unpaid
dividends and arrearage interest. In addition, upon the occurrence of designated Optional
Redemption Events, the holders have the right to require us to redeem the Series B Preferred Stock
at 100% of its stated value ($8.4 million at September 30, 2005), together with all accrued and
unpaid dividends and accrued interest. The terms of the Series B Preferred Stock contain a variety
of affirmative and restrictive covenants, including limitations on indebtedness and liens. Each
share of Series B Preferred Stock is generally entitled to a number of votes equal to 0.875 times
the number of shares of common stock issuable upon conversion of such share of Series B Preferred
Stock. 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 our common stock at an exercise price
of $1.0824 per share, subject to certain anti-dilution adjustments. In June 2003, the exercise
price of the warrants was adjusted to $0.9412 per share. In March 2005, the expiration date of the
warrants was extended from January 2007 to January 2008. In January 2004 warrants to purchase
373,990 shares of common stock were surrendered as consideration, along with cash, for the issuance
of 373,990 shares of common stock.
Based on our internal forecasts and projections, we believe that our cash on hand at September
30, 2005 and the net cash generated from the sale of our non-core products will be sufficient to
fund operations through at least September 30, 2006, unless a substantial portion of our cash is
used for product acquisitions and our revenues are significantly less than we expect.
24
Our future funding requirements will depend on many factors, including: our existing cash
balance; the implementation of our business strategy; the timing and extent of product sales;
returns of expired product; the acquisition and licensing of products, technologies or compounds,
if any; the repositioning of our product portfolio; our ability to manage growth; competing
technological and market developments; costs involved in filing, prosecuting, defending and
enforcing patent and intellectual property claims; the receipt of licensing or milestone fees from
current or future collaborative and license agreements, if established; the timing of regulatory
approvals; the timing and successful completion of the Acthar bioassay transfer; payment of
dividends and compliance to prevent additional dividend events; any expansion or acceleration of
our development programs or optional redemption events, and other factors.
If our cash balance and our revenues are not sufficient to meet our obligations, or if we are
unable to maintain compliance with certain covenants when applicable and thus avoid the payment of
additional dividends of 6% to the holders of our Series B Convertible Preferred Stock, or if we
have insufficient funds to acquire additional products or expand our operations, we will seek to
raise additional capital through public or private equity financing or from other sources. However,
traditional asset-based debt financing has not been available on acceptable terms. Additionally, we
may seek to raise additional capital whenever conditions in the financial markets are favorable,
even if we do not have an immediate need for additional cash at that time. There can be no
assurance that we will be able to obtain additional funds on desirable terms or at all.
RISK FACTORS
We have a history of operating losses and may never generate sufficient revenue to achieve profitability.
We have a history of recurring operating losses. Our accumulated deficit through September 30,
2005 was $84.7 million, of which $222,000 and $1.5 million represented the net loss applicable to
common shareholders for the three months ended September 30, 2005 and 2004, respectively, and
$310,000 and $1.9 million represented the net loss applicable to common shareholders for the nine
months ended September 30, 2005 and 2004, respectively. To date, our revenues have been generated
principally from sales of Acthar, Nascobal, Ethamolin, Glofil-125, Inulin and VSL#3. In October
2005, we sold Nascobal, Ethamolin and Glofil-125, and accordingly we will no longer be selling such
products. The promotion agreement for VSL#3 expired in January 2005, and we will no longer be
selling VSL#3. We discontinued selling Inulin in September 2003. We do not expect Emitasol,
Hypnostat or Panistat to be commercially available for a number of years, if at all.
Our ability to achieve a consistent, profitable level of operations will be dependent in large
part upon our ability to:
|
|
|
develop, finance and implement an effective promotional strategy for Acthar, |
|
|
|
|
finance and acquire additional marketed products, |
|
|
|
|
finance operations until consistent positive cash flows are achieved, |
|
|
|
|
transfer the Acthar potency bioassay, |
|
|
|
|
continue to receive product from our sole-source contract manufacturer on a timely basis and at acceptable costs, |
|
|
|
|
continue to control our operating expenses, and |
|
|
|
|
ensure customers compliance with our sales and product return policies. |
If we are unable to generate sufficient revenues from sales of Acthar, or if we are unable to
contain costs and expenses, we may not achieve profitability and may ultimately be unable to fund
our operations.
If our revenues from product sales decline or fail to grow, we may not have sufficient revenues to fund our operations.
We currently rely exclusively on sales of Acthar. We expect to continue to rely on sales of
this product in the foreseeable future. We review external data sources to estimate customer demand
for Acthar. In the event that demand for Acthar is less than our sales to wholesalers, excess
inventory may result at the wholesaler level, which may impact future product sales. If the supply
of Acthar available at the wholesale level exceeds the future demand, our future revenues from the
sales of Acthar may be affected adversely.
25
We monitor the amount of Acthar at the wholesale level as well as prescription data obtained
from third party sources to help assess product demand. Although our goal is to actively promote
Acthar, and we have no reason to believe that our promotion of Acthar will not be successful, we
cannot predict whether the demand for Acthar will continue in the future or that we will continue
to generate significant revenues from sales of Acthar. We may choose, in the future, to reallocate
our sales and promotion efforts for Acthar which may result in a decrease in revenues from this
product. If the demand for Acthar declines, or if we are forced to reduce the price, or if returns
of expired products are higher than anticipated, or if we are forced to re-negotiate contracts or
terms, or if our customers do not comply with our existing policies, our revenues from the sale of
Acthar would decline. If the cost to produce Acthar increases, and we are unable to raise the price
correspondingly, our gross margins on the sale of Acthar would decline. If our revenues from the
sale of Acthar decline or fail to grow, our total revenues, gross margins and operating results
would be harmed and we may not have sufficient revenues to fund our operations.
Our business will be harmed if we are unable to implement our growth strategy successfully.
Our growth strategy primarily includes the following components:
|
|
|
Initially focusing our promotional efforts on Acthar, our neurological product, |
|
|
|
|
Acquiring additional pharmaceutical products that have sales growth potential, are
promotionally responsive to a focused and targeted sales and marketing effort, complement
our therapeutic focus on neurology and can be acquired at a reasonable valuation
relative to our cost of capital, and |
|
|
|
|
Developing new medications focused on our target markets through corporate
collaborations. |
Any failure on our part to implement any or all of our growth strategies successfully
would likely have a material adverse effect on our financial condition.
If we are unsuccessful in completing the Acthar potency bioassay transfer, we may be unable to
meet the demand for Acthar and lose potential revenues.
Any delays or problems associated with the transfer of the Acthar potency bioassay to a new
contract laboratory could reduce the amount of the product that will be available for sale and
adversely affect our operating results. We have selected a new contract laboratory to perform
three bioassays associated with the release of API and finished goods. Two of these bioassays have
been successfully transferred to the contract laboratory. We have experienced delays and cost
overruns in the validation of the third assay, potency. ZLB has agreed to support Questcor through
2006 by continuing to conduct the potency testing and assist us on the potency assay transfer. Work
on this assay transfer restarted in mid-2005. There can be no assurances that we will be
successful in transferring this assay. If this laboratory is unable to validate this specific
assay, we may be forced to find a new contractor to complete this work, which in turn could
increase our costs substantially. If we are unable to validate the potency assay and receive FDA
approval before the end of 2006, we will not be able to release API and finished goods and
therefore we may not be able to meet the expected demand for Acthar.
We have little or no control over our wholesalers buying patterns, which may impact future
revenues, exchanges and excess inventory.
We sell our products primarily through major drug wholesalers located in the United States.
Consistent with the pharmaceutical industry, most of our revenues are derived from the three
largest drug wholesalers. These wholesalers represented over 81% of our gross product sales for
fiscal year 2004. While we attempt to estimate inventory levels of our products at the three
largest wholesalers using inventory data obtained from them, historical prescription information
and historical purchase patterns, this process is inherently imprecise. We rely solely upon the
wholesalers to effect the distribution allocation of our products. There can be no assurance that
these wholesalers will adequately manage their local and regional inventories to avoid outages or
inventory build-ups. On occasion we note that the wholesalers buy quantities of product in excess
of the quantities being sold by them, resulting in increasing inventories.
Acthar has an expiration date that is 18 months from date of manufacture. We will generally
accept for exchange or credit pharmaceutical products returned within the six month period
following the expiration date. We establish reserves for these exchanges or credit memoranda at the
time of sale. There can be no assurance that we will be able to accurately forecast the reserve
requirements needed to provide for exchanges or credit memoranda issued in the future. Although our
estimates are reviewed quarterly for
26
reasonableness, our product return activity could differ significantly from our estimates
because our analysis of product shipments, prescription trends and the amount of product in the
distribution channel may not be accurate. Judgment is required in estimating these reserves. Actual
amounts could be significantly different from the estimates and such differences are accounted for
in the period in which they become known.
We do not control or significantly influence the purchasing patterns of the drug wholesalers
who purchase our products. These are sophisticated companies that purchase our products in a manner
consistent with their industry practices and perceived business interests. Our sales are subject to
the purchase requirements of the major wholesalers, which, presumably, are based upon their
projected demand levels. Purchases by any customer, during any period, may be above or below actual
prescription volumes of one or more of our products during the same period, resulting in increases
or decreases in product inventory existing in the distribution channel.
We provide reserves for potentially excess, dated or otherwise impaired inventory. Reserves
for excess finished goods and work-in-process inventories are based on an analysis of expected
future sales that will occur before the inventory on hand expires. Reserves for raw material
inventories are based on viability and projected future use. Judgment is required in estimating
reserves for excess or impaired inventories. Actual amounts of required reserves could be different
from the estimates and such differences are accounted for in the period in which they become known.
Our inability to secure additional funding could lead to a loss of your investment.
We anticipate that our capital resources based on our internal forecasts and projections will
be adequate to fund operations and capital expenditures through at least September 30, 2006. If we
experience unanticipated cash requirements and if revenues are less than we expect, we could be
required to raise additional capital. Regardless, we may seek additional funds before the end of
2006, through public or private equity financing or from other sources. Additionally, we may seek
to raise capital whenever conditions in the financial markets are favorable, even if we do not have
an immediate need for additional cash at that time. There can be no assurance that additional funds
can be obtained on desirable terms or at all.
If revenues from product sales are less than we expect or if further capital resources are not
available, or if such resources cannot be obtained on attractive terms to us, this may further
limit our ability to fund operations. Our future capital requirements will depend on many factors,
including the following:
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existing product sales performance, |
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successfully implementing our growth strategy, |
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achieving better operating efficiencies, |
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maintaining customer compliance with our policies, |
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obtaining product from our sole-source contract manufacturers and completing the Acthar potency bioassay, and |
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acquiring or developing additional products. |
We may obtain additional financing through public or private debt or equity financings.
However, additional financing may not be available to us on acceptable terms, if at all. Further,
additional equity financings will be dilutive to our stockholders. If sufficient capital is not
available, then we may be required to reduce our operations or to delay, reduce the scope of,
eliminate or divest one or more of our products or manufacturing efforts.
If we are unable to contract with third party contract manufacturers, we may be unable to meet the
demand for our products and lose potential revenues.
We rely on contract manufacturers to produce our marketed product, Acthar, and will likely do
the same for other products that we may develop, commercialize or acquire in the future. Contract
manufacturers may not be able to meet our needs with respect to timing, cost, quantity or quality.
All our manufacturers are sole-source manufacturers and no currently qualified alternative
suppliers exist.
27
If we are unable to contract for a sufficient supply of our required products and services on
acceptable terms, or if we should encounter delays or difficulties in our relationships with our
manufacturers, or if the required approvals by the FDA and other regulatory authorities do not
occur on a timely basis, we will lose sales. Moreover, contract manufacturers that we may use must
continually adhere to current good manufacturing practices enforced by the FDA. If the facilities
of these manufacturers cannot pass an inspection, we may lose FDA approval of our products. Failure
to obtain products for sale for any reason may result in an inability to meet product demand and a
loss of potential revenues.
If our third party distributors are unable to distribute our products or the costs to distribute
our products increase substantially, we will lose potential revenues and profits.
We transferred certain product distribution functions, including warehousing, shipping and
quality control studies, to third party distributors. The outsourcing of these functions is
complex, and we may experience difficulties at the third party contractor level that could reduce,
delay or stop shipments of our products. If we encounter such distribution problems, our products
could become unavailable and we could lose revenues, or the costs to distribute these products
could become higher than we anticipated.
In fiscal year 2004, 81% of our gross product sales were derived from the three largest drug
wholesalers. Two of these three wholesalers mandate a distribution fee for handling our products.
If other wholesalers institute similar fees, or if such fees increase in magnitude in the future,
our costs to distribute products will increase, and our gross profit margins will decline.
The Company has experienced changes in key personnel which will have an uncertain impact on future
operations.
On February 18, 2005, Mr. James L. Fares was named President and Chief Executive Officer,
succeeding Mr. Charles J. Casamento who resigned as Chairman, President and Chief Executive Officer
on August 5, 2004. On March 8, 2005, Mr. Steve Cartt was named Executive Vice President of
Commercial Development. We are highly dependent on the services of our President and Chief
Executive Officer, Mr. James L. Fares and our Executive Vice President of Commercial Development,
Mr. Steve Cartt. If we were to lose Mr. Fares or Mr. Cartt, as employees, our business could be
harmed.
We do not carry key person life insurance for our senior management or other personnel.
Additionally, the future potential growth and expansion of our business is expected to place
increased demands on our management skills and resources. Although some changes in staffing levels
are expected during 2005, recruiting and retaining management and operational personnel to perform
sales and marketing, financial operations, business development, regulatory affairs, quality
assurance, medical affairs and contract manufacturing in the future will also be critical to our
success. We do not know if we will be able to attract and retain skilled and experienced management
and operational personnel in the future on acceptable terms given the intense competition among
numerous pharmaceutical and biotechnology companies for such personnel. If we are unable to hire
necessary skilled personnel in the future, our business could be harmed.
Our products may not be accepted by the market, which may result in lower future revenues as well
as a decline in our competitive positioning.
Acthar and any products that we successfully acquire or develop in the future, if approved for
marketing, may never achieve market acceptance. These products, if successfully developed, will
compete with drugs and therapies manufactured and marketed by major pharmaceutical and other
biotechnology companies. Physicians, patients or the medical community in general may not accept
and utilize the products that we may develop or that our corporate partners may develop.
The degree of market acceptance of our commercial products and any products that we
successfully develop will depend on a number of factors, including:
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The establishment and demonstration of the clinical efficacy and safety of the product candidates, |
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Their potential advantage over alternative treatment methods and competing products, |
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Reimbursement policies of government and third party payers, and |
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Our ability to market and promote the products effectively. |
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The failure of our products to achieve market acceptance may result in lower future revenues
as well as a decline in our competitive positioning.
A large percentage of our voting stock is beneficially owned by a small number of stockholders,
who in the future could attempt to take control of our management and operations or exercise
voting power to advance their own best interests and not necessarily those of other stockholders.
As of September 30, 2005, Sigma-Tau Finanziaria SpA and its affiliates (Sigma-Tau)
beneficially own, directly or indirectly, approximately 22% of the voting power of our outstanding
voting capital stock, and they beneficially own approximately 26% of our outstanding common stock.
Additionally, we have several other stockholders who own significant amounts of our voting capital
stock, as reported on various Schedule 13Ds filed with the Securities and Exchange Commission.
Accordingly, these stockholders, acting individually or together, could control the outcome of
certain shareholder votes, including votes concerning the election of directors, the adoption or
amendment of provisions in our Articles of Incorporation, and the approval of mergers and other
significant corporate transactions. This level of concentrated ownership may, at a minimum, have
the effect of delaying or preventing a change in the management or voting control of us by a third
party. It may also place us in the position of having these large stockholders take control of us
and having new management inserted and new objectives adopted.
If competitors develop and market products that are more effective than ours, our commercial
opportunity will be reduced or eliminated.
The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid
and significant technological change. A number of companies are pursuing the development of
pharmaceuticals and products that target the same diseases and conditions that we target. For
example, there are products on the market that compete with Acthar. Moreover, technology controlled
by third parties that may be advantageous to our business may be acquired or licensed by
competitors of ours, preventing us from obtaining this technology on favorable terms, or at all.
Our ability to compete will depend on our ability to create and maintain scientifically
advanced technology, and to develop, acquire and commercialize pharmaceutical products based on
this technology, as well as our ability to attract and retain qualified personnel, obtain patent
protection, or otherwise develop proprietary technology or processes, and secure sufficient capital
resources for the expected substantial time period between technological conception and commercial
sales of products based upon our technology.
Many of the companies developing competing technologies and products have significantly
greater financial resources and expertise in development, manufacturing, obtaining regulatory
approvals, and marketing than we do. Other smaller companies may also prove to be significant
competitors, particularly through collaborative arrangements with large and established companies.
Academic institutions, government agencies and other public and private research organizations
may also seek patent protection and establish collaborative arrangements for clinical development,
manufacturing, and marketing of products similar to ours. These companies and institutions will
compete with us in recruiting and retaining qualified sales and marketing and management personnel,
as well as in acquiring technologies complementary to our programs. We will face competition with
respect to:
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product efficacy and safety, |
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the timing and scope of regulatory approvals, |
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availability of resources, |
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price, and |
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patent position, including potentially dominant patent positions of others. |
If our competitors succeed in developing technologies and drugs that are more effective or
less costly than any that we develop or acquire, our technology and future drugs may be rendered
obsolete and noncompetitive. In addition, our competitors may succeed in obtaining the approval of
the FDA or other regulatory approvals for drug candidates more rapidly than we will. Companies that
complete clinical trials, obtain required regulatory agency approvals and commence commercial sale
of their drugs before their competitors may achieve a significant competitive advantage, including
patent and FDA marketing exclusivity rights that would delay
29
our ability to market specific products. We do not know if drugs resulting from the joint
efforts of our existing or future collaborative partners will be able to compete successfully with
our competitors existing products or products under development or whether we will obtain
regulatory approval in the U.S. or elsewhere.
If we fail to maintain or enter into new contracts related to collaborations and in-licensed or
acquired technology and products, our product development and commercialization could be delayed.
Our business model has been dependent on our ability to enter into licensing and acquisition
arrangements with commercial or academic entities to obtain technology for commercialization or
marketed products. If we are unable to enter into any new agreements in the future, our development
and commercialization efforts will be delayed. Disputes may arise regarding the inventorship and
corresponding rights in inventions and know-how resulting from the joint creation or use of
intellectual property by us and our licensors or scientific collaborators. We may not be able to
negotiate additional license and acquisition agreements in the future on acceptable terms, if at
all. In addition, current license and acquisition agreements may be terminated, and we may not be
able to maintain the exclusivity of our exclusive licenses.
If collaborators do not commit sufficient development resources, technology, regulatory
expertise, manufacturing, marketing and other resources towards developing, promoting and
commercializing products incorporating our discoveries, the progress of our licensed products
development will be stalled. Further, competitive conflicts may arise among these third parties
that could prevent them from working cooperatively with us. The amount and timing of resources
devoted to these activities by the parties could depend on the achievement of milestones by us and
otherwise generally may be controlled by other parties. In addition, we expect that our agreements
with future collaborators will likely permit the collaborators to terminate their agreements upon
written notice to us. This type of termination would substantially reduce the likelihood that the
applicable research program or any lead candidate or candidates would be developed into a drug
candidate, would obtain regulatory approvals and would be manufactured and successfully
commercialized.
If none of our collaborations are successful in developing and commercializing products, or if
we do not receive milestone payments or generate revenues from royalties sufficient to offset our
significant investment in product development and other costs, then our business could be harmed.
Disagreements with our collaborators could lead to delays or interruptions in, or termination of,
development and commercialization of certain potential products or could require or result in
litigation or arbitration, which could be time-consuming and expensive and may result in lost
revenues and substantial legal costs which could negatively impact our results from operations. In
addition, if we are unable to acquire new marketed products on a timely basis at an appropriate
purchase price and terms, we may not reach profitability and may not generate sufficient cash to
fund operations.
If we are unable to protect our proprietary rights, we may lose our competitive position and
future revenues.
Our success will depend in part on our ability to:
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obtain patents for our products and technologies, |
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protect trade secrets, |
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operate without infringing upon the proprietary rights of others, and |
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prevent others from infringing on our proprietary rights. |
We will only be able to protect our proprietary rights from unauthorized use by third parties
to the extent that these rights are covered by valid and enforceable patents or are effectively
maintained as trade secrets and are otherwise protectable under applicable law. We will attempt to
protect our proprietary position by filing U.S. and foreign patent applications related to our
proprietary products, technology, inventions and improvements that are important to the development
of our business.
The patent positions of biotechnology and biopharmaceutical companies involve complex legal
and factual questions and, therefore, enforceability cannot be predicted with certainty. Patents,
if issued, may be challenged, invalidated or circumvented. Thus, any patents that we own or license
from third parties may not provide any protection against competitors. Pending patent applications
we may file in the future, or those we may license from third parties, may not result in patents
being issued. Also, patent rights may not provide us with proprietary protection or competitive
advantages against competitors with similar technology. Furthermore, others
30
may independently develop similar technologies or duplicate any technology that we have
developed or we will develop. The laws of some foreign countries may not protect our intellectual
property rights to the same extent as do the laws of the United States.
In addition to patents, we rely on trade secrets and proprietary know-how. We currently seek
protection, in part, through confidentiality and proprietary information agreements. These
agreements may not provide meaningful protection or adequate remedies for proprietary technology in
the event of unauthorized use or disclosure of confidential and proprietary information. The
parties may not comply with or may breach these agreements. Furthermore, our trade secrets may
otherwise become known to, or be independently developed by competitors.
Our success will further depend, in part, on our ability to operate without infringing the
proprietary rights of others. If our activities infringe on patents owned by others, we could incur
substantial costs in defending ourselves in suits brought against a licensor or us. Should our
products or technologies be found to infringe on patents issued to third parties, the manufacture,
use and sale of our products could be enjoined, and we could be required to pay substantial
damages. In addition, we, in connection with the development and use of our products and
technologies, may be required to obtain licenses to patents or other proprietary rights of third
parties, which may not be made available on terms acceptable to us, if at all.
Since we must obtain regulatory approval to market our products in the United States and in
foreign jurisdictions, we cannot predict whether or when we will be permitted to commercialize our
products.
Any products that we develop are subject to regulation by federal, state and local
governmental authorities in the United States, including the FDA, and by similar agencies in other
countries. Any product that we develop must receive all relevant regulatory approvals or clearances
before it may be marketed in a particular country. The regulatory process, which includes extensive
preclinical studies and clinical trials of each product to establish its safety and efficacy, is
uncertain, can take many years, and requires the expenditure of substantial resources. Data
obtained from preclinical and clinical activities are susceptible to varying interpretations that
could delay, limit or prevent regulatory approval or clearance. In addition, delays or rejections
may be encountered based upon changes in regulatory policy during the period of product development
and the period of review of any application for regulatory approval or clearance for a product.
Delays in obtaining regulatory approvals or clearances could:
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stall the marketing, selling and distribution of any products that our corporate partners or we develop, |
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impose significant additional costs on our corporate partners and us, |
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diminish any competitive advantages that we or our corporate partners may attain, and |
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decrease our ability to receive royalties and generate revenues and profits. |
Regulatory approval, if granted, may entail limitations on the indicated uses for which a new
product may be marketed that could limit the potential market for the product. Product approvals,
once granted, may be withdrawn if problems occur after initial marketing. Furthermore,
manufacturers of approved products are subject to pervasive review, including compliance with
detailed regulations governing FDA good manufacturing practices. The FDA periodically revises the
good manufacturing practices regulations. Failure to comply with applicable regulatory requirements
can result in warning letters, fines, injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, refusal of the government to grant marketing
applications and criminal prosecution.
In addition, we cannot predict the extent of government regulations or the impact of new
governmental regulations that may result in a delay in the development, production and marketing of
our products. As such, we may be required to incur significant costs to comply with current or
future laws or regulations.
Our ability to generate revenues is affected by the availability of reimbursement on our products,
and our ability to generate revenues will be diminished if we fail to obtain an adequate level of
reimbursement for our products from third party payors.
In both domestic and foreign markets, sales of our products will depend in part on the
availability of reimbursement from third party payors such as state and federal governments (for
example, under Medicare and Medicaid programs in the United States) and private insurance plans. In
certain foreign markets, the pricing and profitability of our products generally are subject to
government controls. In the United States, there have been, and we expect there will continue to
be, a number of state and federal proposals that limit the amount that state or federal governments
will pay to reimburse the cost of drugs. We believe the increasing emphasis on
31
managed care in the United States has and will continue to put pressure on the price and usage
of our products, which may also impact product sales. Further, when a new therapeutic is approved,
the reimbursement status and rate of such a product is uncertain. In addition, current
reimbursement policies for existing products may change at any time. Changes in reimbursement or
our failure to obtain reimbursement for our products may reduce the demand for, or the price of,
our products, which could result in lower product sales or revenues, thereby weakening our
competitive position and negatively impacting our results of operations.
In the United States, proposals have called for substantial changes in the Medicare and
Medicaid programs. Any such changes enacted may require significant reductions from currently
projected government expenditures for these programs. The Medicare Prescription Drug Improvement
Act, enacted in December 2003, provides for, among other things, an immediate reduction in the
Medicare reimbursement rates for many drugs administered in a physicians office. The Medicare Act,
as well as other changes in government legislation or regulation or in private third party payors
policies toward reimbursement for our products, may reduce or eliminate reimbursement of our
products costs. Driven by budget concerns, Medicaid managed care systems have been implemented in
several states and local metropolitan areas. If the Medicare and Medicaid programs implement
changes that restrict the access of a significant population of patients to innovative medicines,
the market acceptance of these products may be reduced. We are unable to predict what impact the
Medicare Act or other future legislation, if any, relating to third party reimbursement, will have
on our product sales.
To facilitate the availability of our products for Medicaid patients, we have contracted with
the Center for Medicare and Medicaid Services. As a result, we pay quarterly rebates consistent
with the utilization of our products by individual states. We also give discounts under contract on
purchases or reimbursements of pharmaceutical products by certain other federal and state agencies
and programs. If these discounts and rebates become burdensome to us and we are not able to sell
our products through these channels, our net sales could decline.
Our business is subject to changing regulation of corporate governance and public disclosure that
has increased both our costs and the risk of noncompliance.
Because our common stock is publicly traded, we are subject to certain rules and regulations
of federal, state and financial market exchange entities charged with the protection of investors
and the oversight of companies whose securities are publicly traded. These entities, including the
Public Company Accounting Oversight Board, the SEC and the American Stock Exchange, have recently
issued new requirements and regulations and continue developing additional regulations and
requirements in response to recent corporate scandals and laws enacted by Congress, most notably
the Sarbanes-Oxley Act of 2002. Our efforts to comply with these new regulations have resulted in,
and are likely to continue resulting in, increased general and administrative expenses and
diversion of management time and attention from revenue-generating activities to compliance
activities.
In particular, our efforts to prepare to comply with Section 404 of the Sarbanes-Oxley Act and
related regulations for fiscal years ending on or after July 15, 2007 regarding our managements
required assessment of our internal control over financial reporting and our independent auditors
attestation of that assessment will require the commitment of significant financial and managerial
resources. Although management believes that ongoing efforts to assess our internal control over
financial reporting will enable management to provide the required report, and our independent
auditors to provide the required attestation, under Section 404, we can give no assurance that such
efforts will be completed on a timely and successful basis to enable our management and independent
auditors to provide the required report and attestation in order to comply with SEC rules effective
for us.
Moreover, because the new and changed laws, regulations and standards are subject to varying
interpretations in many cases due to their lack of specificity, their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This evolution may
result in continuing uncertainty regarding compliance matters and additional costs necessitated by
ongoing revisions to our disclosure and governance practices.
Our stock price has a history of volatility, and an investment in our stock could decline in
value.
The price of our common stock, like that of other specialty pharmaceutical companies, is
subject to significant volatility. Our stock price has ranged in value from $0.38 to $1.09 over the
last two years. Any number of events, both internal and external to us, may continue to affect our
stock price. These include, without limitation, the quarterly and yearly revenues and earnings or
losses; our ability to acquire and market appropriate pharmaceuticals; announcement by us or our
competitors regarding product development efforts, including the status of regulatory approval
applications; the outcome of legal proceedings, including claims filed by us against third parties
to enforce our patents and claims filed by third parties against us relating to patents held by the
third parties; the launch of
32
competing products; our ability to obtain product from our contract manufacturers; the
resolution of (or failure to resolve) disputes with collaboration partners and corporate
restructuring by us.
If product liability lawsuits are successfully brought against us or we become subject to other
forms of litigation, we may incur substantial liabilities and costs and may be required to limit
commercialization of our products.
Our business will expose us to potential liability risks that are inherent in the testing,
manufacturing and marketing of pharmaceutical products. The use of any drug candidates ultimately
developed by us or our collaborators in clinical trials may expose us to product liability claims
and possible adverse publicity. These risks will expand for any of our drug candidates that receive
regulatory approval for commercial sale and for those products we currently market. Product
liability insurance for the pharmaceutical industry is generally expensive, if available at all. We
currently have product liability insurance for claims up to $10,000,000. However, if we are unable
to maintain insurance coverage at acceptable costs, in a sufficient amount, or at all, or if we
become subject to a product liability claim, our reputation, stock price and ability to devote the
necessary resources to the commercialization of our products could be negatively impacted.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at September 30, 2005 has not changed materially from December 31,
2004, and reference is made to the more detailed disclosures of market risk included in our Annual
Report on Form 10-K/A for the fiscal year ended December 31, 2004.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and management
is required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not applicable
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable
ITEM 5. OTHER INFORMATION
Not applicable
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ITEM 6. EXHIBITS
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Exhibit No. |
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Description |
31
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Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32*
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Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002. |
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* |
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These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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QUESTCOR PHARMACEUTICALS, INC. |
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Date:
November 14, 2005
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By:
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/s/ JAMES L. FARES |
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James L. Fares |
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President and Chief Executive Officer |
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By:
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/s/ GEORGE STUART |
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George Stuart |
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Chief Financial Officer |
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Exhibit Index
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Exhibit No. |
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Description |
31
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Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32*
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Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002. |
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* |
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These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
exv31
EXHIBIT 31
Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, James L. Fares, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
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a) |
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designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and |
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c) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants internal
control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have
a significant role in the registrants internal control over financial reporting. |
Date:
November 14, 2005
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/s/ JAMES L. FARES
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James L. Fares |
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Chief Executive Officer |
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Certification of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, George Stuart, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
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a) |
|
designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and |
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c) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants internal
control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have
a significant role in the registrants internal control over financial reporting. |
Date:
November 14, 2005
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/s/ GEORGE STUART
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George Stuart |
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Chief Financial Officer |
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exv32
EXHIBIT 32
CERTIFICATIONS
On
November 14, 2005, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2005 (the Form 10-Q) with the Securities and Exchange
Commission. Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of
2002, the following certifications are being made to accompany the Form 10-Q:
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Questcor Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2005 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: November 14, 2005 |
/s/ JAMES L. FARES
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James L. Fares |
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Chief Executive Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Questcor Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2005 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: November 14, 2005 |
/s/ GEORGE STUART
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George Stuart |
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Chief Financial Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.