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þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 65-0403311 | |
(State or other jurisdiction of incorporation or | (I.R.S. Employer Identification No.) | |
organization) | ||
30831 Huntwood Avenue, Hayward, CA | 94544 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filero | Accelerated filerþ | Non-accelerated filero | Smaller reporting companyo | |||
(Do not check if a smaller reporting company) |
PART I: FINANCIAL INFORMATION | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
7 | ||||||||
40 | ||||||||
64 | ||||||||
64 | ||||||||
PART II: OTHER INFORMATION | ||||||||
65 | ||||||||
68 | ||||||||
69 | ||||||||
70 | ||||||||
70 | ||||||||
70 | ||||||||
71 | ||||||||
72 | ||||||||
73 | ||||||||
Exhibit 10.1.1 | ||||||||
Exhibit 10.1.2 | ||||||||
Exhibit 10.7 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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March 31, | December 31, | |||||||
2010 | 2009 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 83,747 | $ | 31,770 | ||||
Short-term investments | 46,615 | 58,599 | ||||||
Accounts receivable, net | 324,692 | 185,854 | ||||||
Inventory, net | 52,015 | 49,130 | ||||||
Current portion of deferred product manufacturing costs-alliance agreements | 11,435 | 11,624 | ||||||
Current portion of deferred income taxes | 35,109 | 32,286 | ||||||
Prepaid expenses and other current assets | 3,963 | 4,748 | ||||||
Total current assets | 557,576 | 374,011 | ||||||
Property, plant and equipment, net | 102,330 | 101,650 | ||||||
Deferred product manufacturing costs-alliance agreements | 95,986 | 96,619 | ||||||
Deferred income taxes, net | 44,570 | 48,544 | ||||||
Other assets | 16,993 | 12,358 | ||||||
Goodwill | 27,574 | 27,574 | ||||||
Total assets | $ | 845,029 | $ | 660,756 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 33,249 | $ | 23,295 | ||||
Accrued expenses | 64,758 | 62,055 | ||||||
Accrued income taxes payable | 78,582 | 31,627 | ||||||
Accrued profit sharing and royalty expenses | 41,307 | 53,695 | ||||||
Current portion of deferred revenue-alliance agreements | 33,433 | 33,196 | ||||||
Total current liabilities | 251,329 | 203,868 | ||||||
Deferred revenue-alliance agreements | 219,727 | 224,522 | ||||||
Other liabilities | 12,212 | 10,139 | ||||||
Total liabilities | $ | 483,268 | $ | 438,529 | ||||
Commitments and contingencies (Note 18) | ||||||||
Stockholders’ equity: | ||||||||
Preferred Stock, $0.01 par value, 2,000,000 shares authorized, 0 shares outstanding at March 31, 2010 and December 31, 2009 | $ | — | $ | — | ||||
Common stock, $0.01 par value, 90,000,000 shares authorized and 62,723,482 and 62,210,089 shares issued at March 31, 2010 and December 31, 2009, respectively | 627 | 622 | ||||||
Additional paid-in capital | 230,908 | 223,239 | ||||||
Treasury stock - 243,729 shares | (2,157 | ) | (2,157 | ) | ||||
Accumulated other comprehensive loss | (177 | ) | (524 | ) | ||||
Retained earnings | 132,313 | 828 | ||||||
361,514 | 222,008 | |||||||
Noncontrolling interest | 247 | 219 | ||||||
Total stockholders’ equity | 361,761 | 222,227 | ||||||
Total liabilities and stockholders’ equity | $ | 845,029 | $ | 660,756 | ||||
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Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2010 | 2009 | |||||||
(unaudited) | (unaudited) | |||||||
Revenues: | ||||||||
Global Product Sales, net | $ | 309,105 | $ | 39,121 | ||||
Private Label product sales | 672 | 1,297 | ||||||
Rx Partner | 4,903 | 10,736 | ||||||
OTC Partner | 1,765 | 1,858 | ||||||
Research Partner | 3,385 | 2,611 | ||||||
Promotional Partner | 3,503 | 3,284 | ||||||
Other | — | 6 | ||||||
Total revenues | 323,333 | 58,913 | ||||||
Cost of revenues | 79,576 | 26,250 | ||||||
Gross profit | 243,757 | 32,663 | ||||||
Operating expenses: | ||||||||
Research and development | 18,309 | 15,789 | ||||||
Patent litigation | 1,984 | 1,017 | ||||||
Litigation settlement | — | 237 | ||||||
Selling, general and administrative | 12,485 | 11,485 | ||||||
Total operating expenses | 32,778 | 28,528 | ||||||
Income from operations | 210,979 | 4,135 | ||||||
Other (expense) income, net | (18 | ) | 55 | |||||
Interest income | 82 | 149 | ||||||
Interest expense | (46 | ) | (294 | ) | ||||
Income before income taxes | 210,997 | 4,045 | ||||||
Provision for income taxes | 79,484 | 1,836 | ||||||
Net income before noncontrolling interest | 131,513 | 2,209 | ||||||
Add back (profit) loss attributable to noncontrolling interest | (28 | ) | 10 | |||||
Net income | $ | 131,485 | $ | 2,219 | ||||
Net Income per share: | ||||||||
Basic | $ | 2.16 | $ | 0.04 | ||||
Diluted | $ | 2.06 | $ | 0.04 | ||||
Weighted average common shares outstanding: | ||||||||
Basic | 61,008,015 | 59,711,133 | ||||||
Diluted | 63,865,678 | 60,222,215 | ||||||
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Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2010 | 2009 | |||||||
(unaudited) | (unaudited) | |||||||
Cash flows from operating activities: | ||||||||
Net income | $ | 131,485 | $ | 2,219 | ||||
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||
Depreciation | 2,946 | 2,544 | ||||||
Amortization of 3.5% Debentures discount and deferred financing costs | — | 150 | ||||||
Amortization of Wachovia Credit Agreement deferred financing costs | 25 | — | ||||||
Bad debt expense | 91 | 23 | ||||||
Deferred income taxes (benefit) | 1,889 | (3,027 | ) | |||||
Provision for uncertain tax positions | 12 | 218 | ||||||
Tax benefit related to the exercise of employee stock options | (738 | ) | — | |||||
Deferred revenue-Alliance Agreements | 5,495 | 19,723 | ||||||
Deferred product manufacturing costs-Alliance Agreements | (3,427 | ) | (9,919 | ) | ||||
Deferred revenue recognized-Alliance Agreements | (10,053 | ) | (15,205 | ) | ||||
Amortization deferred product manufacturing costs-Alliance Agreements | 4,249 | 7,666 | ||||||
Accrued profit sharing and royalty expense | 41,307 | 72 | ||||||
Profit sharing and royalty payments | (53,695 | ) | (252 | ) | ||||
Payments on exclusivity period fee | — | (3,000 | ) | |||||
Payments on accrued litigation settlements | (5,865 | ) | (4,007 | ) | ||||
Share-based compensation expense | 2,873 | 1,437 | ||||||
Accretion of interest income on short-term investments | (64 | ) | (36 | ) | ||||
Changes in assets and liabilities: | ||||||||
Accounts receivable | (138,929 | ) | (18,530 | ) | ||||
Inventory | (2,885 | ) | 2,546 | |||||
Prepaid expenses and other assets | (3,870 | ) | 2,042 | |||||
Accounts payable, accrued expenses and income taxes payable | 64,678 | (3,481 | ) | |||||
Other liabilities | 2,088 | 734 | ||||||
Net cash provided by (used in) operating activities | $ | 37,612 | $ | (18,083 | ) | |||
Cash flows from investing activities: | ||||||||
Purchase of short-term investments | (23,055 | ) | (27,810 | ) | ||||
Maturities of short-term investments | 35,103 | 18,245 | ||||||
Purchases of property, plant and equipment | (3,116 | ) | (3,881 | ) | ||||
Net cash provided by (used in) investing activities | $ | 8,932 | $ | (13,446 | ) | |||
Cash flows from financing activities: | ||||||||
Repayment of long-term debt | — | (36 | ) | |||||
Tax benefit related to the exercise of employee stock options | 738 | — | ||||||
Proceeds from exercise of stock options and ESPP | 4,695 | 334 | ||||||
Net cash provided by financing activities | $ | 5,433 | $ | 298 | ||||
Net increase (decrease) in cash and cash equivalents | $ | 51,977 | $ | (31,231 | ) | |||
Cash and cash equivalents, beginning of period | $ | 31,770 | $ | 69,275 | ||||
Cash and cash equivalents, end of period | $ | 83,747 | $ | 38,044 | ||||
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Three Months Ended | ||||||||
March 31, | March 31, | |||||||
(in $000s) | 2010 | 2009 | ||||||
Cash paid for interest | $ | 46 | $ | 169 | ||||
Cash paid for income taxes | $ | 30,710 | $ | 63 | ||||
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Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
March 31, 2010 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper | $ | 16,278 | $ | 7 | $ | — | $ | 16,285 | ||||||||
Government sponsored enterprise obligations | 27,535 | 9 | (4 | ) | 27,540 | |||||||||||
Corporate bonds | 2,563 | 1 | — | 2,564 | ||||||||||||
Certificates of deposit | 239 | — | — | 239 | ||||||||||||
Total short-term investments | $ | 46,615 | $ | 17 | $ | (4 | ) | $ | 46,628 | |||||||
Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2009 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper | $ | 13,387 | $ | 4 | $ | (1 | ) | $ | 13,390 | |||||||
Government sponsored enterprise obligations | 41,953 | 32 | (1 | ) | 41,984 | |||||||||||
Corporate bonds | 3,021 | 1 | (1 | ) | 3,021 | |||||||||||
Certificates of deposit | 238 | — | — | 238 | ||||||||||||
Total short-term investments | $ | 58,599 | $ | 37 | $ | (3 | ) | $ | 58,633 | |||||||
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March 31, | December 31, | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Gross accounts receivable | $ | 398,648 | $ | 254,094 | ||||
Less: Chargeback reserve | (27,637 | ) | (21,448 | ) | ||||
Less: Rebate reserve | (31,716 | ) | (37,781 | ) | ||||
Less: Other deductions | (14,603 | ) | (9,011 | ) | ||||
Accounts receivable, net | $ | 324,692 | $ | 185,854 | ||||
(in $000’s) | March 31, | December 31 | ||||||
Chargeback reserve | 2010 | 2009 | ||||||
Beginning balance | $ | 21,448 | $ | 4,056 | ||||
Provision recorded during the period | 56,168 | 126,105 | ||||||
Credits issued during the period | (49,979 | ) | (108,713 | ) | ||||
Ending balance | $ | 27,637 | $ | 21,448 | ||||
(in $000’s) | March 31, | December 31 | ||||||
Rebate reserve | 2010 | 2009 | ||||||
Beginning balance | $ | 37,781 | $ | 4,800 | ||||
Provision recorded during the period | 34,824 | 72,620 | ||||||
Credits issued during the period | (40,889 | ) | (39,639 | ) | ||||
Ending balance | $ | 31,716 | $ | 37,781 | ||||
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March 31, | December 31, | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Raw materials | $ | 34,286 | $ | 30,758 | ||||
Work in process | 2,858 | 2,768 | ||||||
Finished goods | 16,235 | 17,051 | ||||||
Total inventory, net | $ | 53,379 | $ | 50,577 | ||||
Less: Non-current inventory, net | (1,364 | ) | (1,447 | ) | ||||
Total inventory-current, net | $ | 52,015 | $ | 49,130 | ||||
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March 31, | December 31, | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Land | $ | 2,270 | $ | 2,270 | ||||
Buildings and improvements | 78,286 | 77,778 | ||||||
Equipment | 61,332 | 59,612 | ||||||
Office furniture and equipment | 7,585 | 7,425 | ||||||
Construction-in-progress | 6,077 | 4,880 | ||||||
Property, plant and equipment, gross | $ | 155,550 | $ | 151,965 | ||||
Less: Accumulated depreciation | (53,220 | ) | (50,315 | ) | ||||
Property, plant and equipment, net | $ | 102,330 | $ | 101,650 | ||||
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March 31 | December 31 | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Payroll-related expenses | $ | 10,184 | $ | 15,274 | ||||
Product returns | 28,599 | 22,114 | ||||||
Shelf stock adjustments | 138 | 225 | ||||||
Medicaid rebates | 16,848 | 9,759 | ||||||
Physician detailing sales force fees | 2,410 | 2,449 | ||||||
Legal and professional fees | 4,126 | 3,660 | ||||||
Litigation settlements | — | 5,865 | ||||||
Other | 2,453 | 2,709 | ||||||
Total accrued expenses | $ | 64,758 | $ | 62,055 | ||||
(in $000’s) | March 31 | December 31 | ||||||
Product Return Reserve | 2010 | 2009 | ||||||
(in $000’s) | ||||||||
Beginning balance | $ | 22,114 | $ | 13,675 | ||||
Provision related to sales recorded in the period | 7,400 | 11,847 | ||||||
Credits issued during the period | (915 | ) | (3,408 | ) | ||||
Ending balance | $ | 28,599 | $ | 22,114 | ||||
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Three Months | ||||||||
Ended | Inception | |||||||
(in $000’s) | March 31, | Through | ||||||
Deferred revenue | 2010 | Dec 31, 2009 | ||||||
Beginning balance | $ | 202,032 | $ | — | ||||
Additions: | ||||||||
Cost-sharing | 175 | 6,653 | ||||||
Product-related deferrals | 4,841 | 410,616 | ||||||
Sub-total | 5,016 | 417,269 | ||||||
Exclusivity charges | — | (50,600 | ) | |||||
Forgiveness of advance deposit | — | 6,000 | ||||||
Forgiveness of interest | — | 4,370 | ||||||
Stock repurchase | — | 2,157 | ||||||
Total additions | $ | 5,016 | $ | 379,196 | ||||
Less: amounts recognized: | ||||||||
Forgiveness of advance deposit | $ | (54 | ) | $ | (2,802 | ) | ||
Forgiveness of interest | (39 | ) | (2,045 | ) | ||||
Stock repurchase | (19 | ) | (1,008 | ) | ||||
Cost-sharing | (126 | ) | (3,092 | ) | ||||
Product-related revenue | (4,664 | ) | (168,217 | ) | ||||
Total amount recognized | (4,902 | ) | (177,164 | ) | ||||
Total deferred revenue | $ | 202,146 | $ | 202,032 | ||||
Three Months | ||||||||
(in $000’s) | Ended | Inception | ||||||
Deferred product | March 31, | Through | ||||||
manufacturing costs | 2010 | Dec 31, 2009 | ||||||
Beginning balance | $ | 94,040 | $ | — | ||||
Additions | 2,987 | 175,565 | ||||||
Less amounts amortized | (2,705 | ) | (81,525 | ) | ||||
Total deferred product manufacturing costs | $ | 94,322 | $ | 94,040 | ||||
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Three Months | ||||||||
Ended | Inception | |||||||
(in $000’s) | March 31 | Through | ||||||
Deferred revenue | 2010 | Dec 31, 2009 | ||||||
Beginning balance | $ | 16,162 | $ | — | ||||
Additions: | ||||||||
Upfront fees and milestone payments | — | 8,436 | ||||||
Cost-sharing and other | — | 1,642 | ||||||
Product-related deferrals | 479 | 83,826 | ||||||
Total additions | $ | 479 | $ | 93,904 | ||||
Less: amount recognized: | ||||||||
Upfront fees and milestone payments | (69 | ) | (7,745 | ) | ||||
Cost-sharing and other | (187 | ) | (1,550 | ) | ||||
Product-related revenue | (1,509 | ) | (68,447 | ) | ||||
Total amount recognized | (1,765 | ) | (77,742 | ) | ||||
Total deferred revenue | $ | 14,876 | $ | 16,162 | ||||
Three Months | ||||||||
(in $000’s) | Ended | Inception | ||||||
Deferred product | March 31, | Through | ||||||
manufacturing costs | 2010 | Dec 31, 2009 | ||||||
Beginning balance | $ | 14,203 | $ | — | ||||
Additions: | 440 | 77,870 | ||||||
Less: amount amortized: | (1,544 | ) | (63,667 | ) | ||||
Total deferred product manufacturing costs | $ | 13,099 | $ | 14,203 | ||||
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Three Months | ||||||||
Ended | Inception | |||||||
(in $000’s) | March 31, | Through | ||||||
Deferred revenue | 2010 | Dec 31, 2009 | ||||||
Beginning balance | $ | 39,487 | $ | — | ||||
Additions: | ||||||||
Upfront fees and milestone payments | — | 52,000 | ||||||
Product-related deferrals | — | — | ||||||
Total additions | $ | — | $ | 52,000 | ||||
Less: amounts recognized: | ||||||||
Upfront fees and milestone payments | (3,385 | ) | (12,513 | ) | ||||
Product-related revenue | — | — | ||||||
Total amount recognized | (3,385 | ) | (12,513 | ) | ||||
Total deferred revenue | $ | 36,102 | $ | 39,487 | ||||
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Three Months Ended: | ||||||||
March 31, | March 31, | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Manufacturing expenses | $ | 898 | $ | 349 | ||||
Research and development | 898 | 602 | ||||||
Selling, general & administrative | 1,077 | 486 | ||||||
Total | $ | 2,873 | $ | 1,437 | ||||
Weighted Average | ||||||||
Number of Shares | Exercise Price | |||||||
Under Option | per Share | |||||||
Outstanding at December 31, 2009 | 8,229,818 | $ | 9.87 | |||||
Options granted | — | $ | — | |||||
Options exercised | (488,359 | ) | $ | 8.61 | ||||
Options forfeited | (32,363 | ) | $ | 8.97 | ||||
Outstanding at March 31, 2010 | 7,709,096 | $ | 9.96 | |||||
Vested and expected to vest at March 31, 2010 | 7,850,433 | $ | 10.01 | |||||
Options exercisable at March 31, 2010 | 4,339,478 | $ | 11.39 | |||||
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Weighted Average | ||||||||
Restricted | Number of Restricted | Grant-Date | ||||||
Stock Awards | Stock Awards | Fair Value | ||||||
Non-vested at December 31, 2009 | 1,152,923 | $ | 7.72 | |||||
Granted | 37,200 | $ | 13.65 | |||||
Vested | (108,020 | ) | $ | 8.43 | ||||
Forfeited | (8,823 | ) | $ | 7.88 | ||||
Non-vested at March 31, 2010 | 1,073,280 | $ | 7.85 | |||||
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Three Months Ended: | ||||||||
March 31, | March 31 | |||||||
(in $000’s except per share amounts) | 2010 | 2009 | ||||||
Numerator: | ||||||||
Net income | $ | 131,485 | $ | 2,219 | ||||
Denominator: | ||||||||
Weighted average common shares outstanding | 61,008,015 | 59,711,133 | ||||||
Effect of dilutive options and common stock purchase warrants | 2,857,663 | 511,082 | ||||||
Diluted weighted average common shares outstanding | 63,865,678 | 60,222,215 | ||||||
Basic net income per share | $ | 2.16 | $ | 0.04 | ||||
Diluted net income per share | $ | 2.06 | $ | 0.04 | ||||
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Three Months Ended: | ||||||||
March 31, | March 31, | |||||||
(in $000’s) | 2010 | 2009 | ||||||
Net income | $ | 131,485 | $ | 2,219 | ||||
Currency translation adjustments | 347 | (700 | ) | |||||
Comprehensive income | 131,832 | 1,519 | ||||||
Comprehensive income attributable to the noncontrolling interest | — | — | ||||||
Comprehensive income attributable to Impax Laboratories, Inc. | $ | 131,832 | $ | 1,519 | ||||
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(in $000’s) | Global | Impax | Corporate | Total | ||||||||||||
Three Months Ended March 31, 2010 | Division | Division | and Other | Company | ||||||||||||
Revenue, net | $ | 319,830 | $ | 3,503 | $ | — | $ | 323,333 | ||||||||
Cost of revenue | 76,432 | 3,144 | — | 79,576 | ||||||||||||
Research and development | 9,435 | 8,874 | — | 18,309 | ||||||||||||
Patent Litigation | 1,984 | — | — | 1,984 | ||||||||||||
Income (loss) before provision for income taxes | $ | 228,645 | $ | (9,324 | ) | $ | (8,324 | ) | $ | 210,997 |
(in $000’s) | Global | Impax | Corporate | Total | ||||||||||||
Three Months Ended March 31, 2009 | Division | Division | and Other | Company | ||||||||||||
Revenue, net | $ | 55,629 | $ | 3,284 | $ | — | $ | 58,913 | ||||||||
Cost of revenue | 23,233 | 3,017 | — | 26,250 | ||||||||||||
Research and development | 10,275 | 5,514 | — | 15,789 | ||||||||||||
Patent Litigation | 1,017 | — | — | 1,017 | ||||||||||||
Income (loss) before provision for income taxes | $ | 18,510 | $ | (6,287 | ) | $ | (8,178 | ) | $ | 4,045 |
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Quarter Ended: | ||||
(in $000’s except per share amounts) | March 31, 2010 | |||
Revenue: | ||||
Gross Global Product Sales | $ | 425,986 | ||
Less: | ||||
Chargebacks | 56,168 | |||
Rebates | 29,425 | |||
Product Returns | 7,400 | |||
Other credits | 23,888 | |||
Global Product Sales, net | 309,105 | |||
Private Label product sales | 672 | |||
Rx Partner | 4,903 | |||
OTC Partner | 1,765 | |||
Research Partner | 3,385 | |||
Promotional Partner | 3,503 | |||
Other | — | |||
Total revenues | 323,333 | |||
Gross profit | 243,757 | |||
Net income | $ | 131,485 | ||
Net income per share (basic) | $ | 2.16 | ||
Net income per share (diluted) | $ | 2.06 | ||
Weighted Average: | ||||
common shares outstanding: | ||||
Basic | 61,008,015 | |||
Diluted | 63,865,678 | |||
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Quarter Ended: | ||||
(in $000’s except per share amounts) | March 31, 2009 | |||
Revenues: | ||||
Gross Global Product Sales | $ | 78,696 | ||
Less: | ||||
Chargebacks | 22,638 | |||
Rebates | 10,819 | |||
Product Returns | 3,256 | |||
Other credits | 2,862 | |||
Global Product Sales, net | 39,121 | |||
Private Label product sales | 1,297 | |||
Rx Partner | 10,736 | |||
OTC Partner | 1,858 | |||
Research Partner | 2,611 | |||
Promotional Partner | 3,284 | |||
Other | 6 | |||
Total revenues | 58,913 | |||
Gross profit | 32,663 | |||
Net income | $ | 2,219 | ||
Net income per share (basic) | $ | 0.04 | ||
Net income per share (diluted) | $ | 0.04 | ||
Weighted average common shares outstanding: | ||||
Basic | 59,711,133 | |||
Diluted | 60,222,215 | |||
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ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION |
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(in $000’s) | March 31, | December 31 | ||||||
Chargeback reserve | 2010 | 2009 | ||||||
Beginning balance | $ | 21,448 | $ | 4,056 | ||||
Provision recorded during the period | 56,168 | 126,105 | ||||||
Credits issued during the period | (49,979 | ) | (108,713 | ) | ||||
Ending balance | $ | 27,637 | $ | 21,448 | ||||
Provision as a percent of Gross Global Product Sales | 13 | % | 24 | % | ||||
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(in $000’s) | March 31, | December 31 | ||||||
Rebate reserve | 2010 | 2009 | ||||||
Beginning balance | $ | 37,781 | $ | 4,800 | ||||
Provision recorded during the period | 34,824 | 72,620 | ||||||
Credits issued during the period | (40,889 | ) | (39,639 | ) | ||||
Ending balance | $ | 31,716 | $ | 37,781 | ||||
Provision as a percent of Gross Global Product Sales | 8 | % | 14 | % | ||||
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(in $000’s) | March 31, | December 31 | ||||||
Product Returns Reserve | 2010 | 2009 | ||||||
Beginning balance | $ | 22,114 | $ | 13,675 | ||||
Provision related to sales recorded in the period | 7,400 | 11,847 | ||||||
Credits issued during the period | (915 | ) | (3,408 | ) | ||||
Ending balance | $ | 28,599 | $ | 22,114 | ||||
Provision as a percent of Gross Global Product Sales | 2 | % | 2 | % | ||||
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Three Months Ended | Increase/ | |||||||||||||||
March 31 | March 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2010 | 2009 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Total revenues | $ | 323,333 | $ | 58,913 | $ | 264,420 | 449 | % | ||||||||
Gross profit | 243,757 | 32,663 | 211,094 | 646 | % | |||||||||||
Income from operations | 210,979 | 4,135 | 206,844 | nm | ||||||||||||
Income before income taxes | 210,997 | 4,045 | 206,952 | nm | ||||||||||||
Provision for income taxes | 79,484 | 1,836 | 77,648 | nm | ||||||||||||
131,513 | 2,209 | 129,304 | nm | |||||||||||||
Non-controlling interest | (28 | ) | 10 | (38 | ) | (380 | )% | |||||||||
Net income | $ | 131,485 | $ | 2,219 | $ | 129,266 | nm | |||||||||
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Three Months Ended | Increase/ | |||||||||||||||
March 31 | March 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2010 | 2009 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenues: | ||||||||||||||||
Global Product Sales, net | $ | 309,105 | $ | 39,121 | $ | 269,984 | 690 | % | ||||||||
Private Label product sales | 672 | 1,297 | (625 | ) | (48 | )% | ||||||||||
Rx Partner | 4,903 | 10,736 | (5,833 | ) | (54 | )% | ||||||||||
OTC Partner | 1,765 | 1,858 | (93 | ) | (5 | )% | ||||||||||
Research Partner | 3,385 | 2,611 | 774 | 30 | % | |||||||||||
Other | — | 6 | (6 | ) | 100 | % | ||||||||||
Total revenues | 319,830 | 55,629 | 264,201 | 475 | % | |||||||||||
Cost of revenues | 76,432 | 23,233 | 53,199 | 229 | % | |||||||||||
Gross profit | 243,398 | 32,396 | 211,002 | 651 | % | |||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 9,435 | 10,275 | (840 | ) | (8 | )% | ||||||||||
Patent litigation | 1,984 | 1,017 | 967 | 95 | % | |||||||||||
Selling, general and administrative | 3,334 | 2,594 | 740 | 29 | % | |||||||||||
Total operating expenses | 14,753 | 13,886 | 867 | 6 | % | |||||||||||
Income from operations | $ | 228,645 | $ | 18,510 | $ | 210,135 | nm | |||||||||
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Three Months Ended, | Increase/ | |||||||||||||||
March 31 | March 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2010 | 2009 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Promotional Partner revenue | $ | 3,503 | $ | 3,284 | 219 | 7 | % | |||||||||
Cost of revenues | 3,144 | 3,017 | 127 | 4 | % | |||||||||||
Gross profit | 359 | 267 | 92 | 34 | % | |||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 8,874 | 5,514 | 3,360 | 61 | % | |||||||||||
Selling, general and administrative | 809 | 1,040 | (231 | ) | (22 | )% | ||||||||||
Total operating expenses | 9,683 | 6,554 | 3,129 | 48 | % | |||||||||||
Loss from operations | $ | (9,324 | ) | $ | (6,287 | ) | (3,037 | ) | (48 | )% | ||||||
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Three Months Ended | Increase/ | |||||||||||||||
March 31 | March 31 | �� | (Decrease) | |||||||||||||
(in $000’s) | 2010 | 2009 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Litigation settlement | $ | — | $ | 237 | (237 | ) | (100 | )% | ||||||||
General and administrative expenses | 8,342 | 7,851 | 491 | 6 | % | |||||||||||
Total operating expenses | 8,342 | 8,088 | 254 | 3 | % | |||||||||||
Loss from operations | (8,342 | ) | (8,088 | ) | (254 | ) | (3 | )% | ||||||||
Other income (expense), net | (18 | ) | 55 | (73 | ) | (133) | % | |||||||||
Interest income | 82 | 149 | (67 | ) | (45 | )% | ||||||||||
Interest expense | (46 | ) | (294 | ) | 248 | 84 | % | |||||||||
Provision for income taxes | $ | 79,484 | $ | 1,836 | 77,648 | nm |
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• | revisions to the Medicaid rebate program by: (a) increasing the rebate percentage for branded drugs dispensed after December 31, 2009 to 23.1% of the average manufacturer price, referred to as “AMP,” with limited exceptions, (b) increasing the rebate for outpatient generic, multiple source drugs dispensed after December 31, 2009 to 13% of AMP; (c) changing the definition of AMP; and (d) effective January 1, 2011, the Medicaid rebate program will be extended to Medicaid managed care plans, with limited exception; |
• | the imposition of annual fees upon manufacturers or importers of branded prescription drugs, which fees will be in amounts determined by the Secretary of Treasury based upon market share and other data; |
• | providing a 50% discount on brand-name prescriptions filled in the Medicare Part D coverage gap beginning in 2011; |
• | imposing increased penalties for the violation of fraud and abuse laws and funding for anti-fraud activities; and |
• | creating a new pathway for approval of biosimilar biological products and granting an exclusivity period of 12 years for branded drug manufacturers of biological products before biosimilar products can be approved for marketing in the U.S. |
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Total | ||||||||||||||
Number of | ||||||||||||||
Shares (or | ||||||||||||||
Units) | ||||||||||||||
Purchased | Maximum Number (or | |||||||||||||
as Part of | Approximate Dollar | |||||||||||||
Average | Publicly | Value) of Shares (or | ||||||||||||
Total Number of | Price Paid | Announced | Units) that May Yet | |||||||||||
Shares (or Units) | Per Share | Plans or | Be Purchased Under | |||||||||||
Period | Purchased(1) | (or Unit) | Programs | the Plans or Programs | ||||||||||
January 1, 2010 to January 31, 2010 | — | — | — | — | ||||||||||
February 1, 2010 to February 28, 2010 | 36,463 shares of common stock | $ | 13.79 | — | — | |||||||||
March 1, 2010 to March 31, 2010 | 7,829 shares of common stock | $ | 16.48 | — | — |
(1) | Represents shares of our common stock that we accepted during the indicated periods as a tax withholding from certain of our employees in connection with the vesting of shares of restricted stock pursuant to the terms of our 2002 Plan. |
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Exhibit No. | Description of Document | |||
10.1.1 | Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, amended and restated as of December 31, 2007 and effective as of January 1, 2008.* | |||
10.1.2 | Amendment to Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, effective as of January 1, 2009.* | |||
10.2 | Employment Agreement dated as of January 1, 2010 between the Company and Larry Hsu, Ph.D.* (1) | |||
10.3 | Employment Agreement dated as of January 1, 2010 between the Company and Arthur A. Koch, Jr.* (1) | |||
10.4 | Employment Agreement dated as of January 1, 2010 between the Company and Christopher Mengler, R.Ph.* (1) | |||
10.5 | Employment Agreement dated as of January 1, 2010 between the Company and Michael J. Nestor.* (1) | |||
10.6 | Employment Agreement dated as of January 1, 2010 between the Company and Charles V. Hildenbrand.* (1) | |||
10.7 | Fourth Amendment to Amended and Restated Loan and Security Agreement, dated as of March 19, 2010, by and among the Company and Wachovia Bank, National Association. | |||
11.1 | Statement re computation of per share earnings (incorporated by reference to Note 14 to the Notes to the unaudited interim Consolidated Financial Statements in this Quarterly Report on Form 10-Q). | |||
31.1 | Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
31.2 | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
32.1 | Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
32.2 | Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* | Management contract, compensatory plan or arrangement. | |
(1) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010. |
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Date: May 6, 2010 | Impax Laboratories, Inc. | |||
By: | /s/ Larry Hsu, Ph.D. | |||
Name: | Larry Hsu, Ph.D. | |||
Title: | President and Chief Executive Officer (Principal Executive Officer) | |||
By: | /s/ Arthur A. Koch, Jr. | |||
Name: | Arthur A. Koch Jr. | |||
Title: | Senior Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) |
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Exhibit No. | Description of Document | |||
10.1.1 | Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, amended and restated as of December 31, 2007 and effective as of January 1, 2008.* | |||
10.1.2 | Amendment to Impax Laboratories, Inc. Executive Non-Qualified Deferred Compensation Plan, effective as of January 1, 2009.* | |||
10.2 | Employment Agreement dated as of January 1, 2010 between the Company and Larry Hsu, Ph.D.* (1) | |||
10.3 | Employment Agreement dated as of January 1, 2010 between the Company and Arthur A. Koch, Jr.* (1) | |||
10.4 | Employment Agreement dated as of January 1, 2010 between the Company and Christopher Mengler, R.Ph.* (1) | |||
10.5 | Employment Agreement dated as of January 1, 2010 between the Company and Michael J. Nestor.* (1) | |||
10.6 | Employment Agreement dated as of January 1, 2010 between the Company and Charles V. Hildenbrand.* (1) | |||
10.7 | Fourth Amendment to Amended and Restated Loan and Security Agreement, dated as of March 19, 2010, by and among the Company and Wachovia Bank, National Association. | |||
11.1 | Statement re computation of per share earnings (incorporated by reference to Note 14 to the Notes to the unaudited interim Consolidated Financial Statements in this Quarterly Report on Form 10-Q). | |||
31.1 | Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
31.2 | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
32.1 | Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
32.2 | Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* | Management contract, compensatory plan or arrangement. | |
(1) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010. |
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