Impax Laboratories, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware
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001-34263
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65-0403311
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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30831 Huntwood Avenue, Hayward, CA
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94544
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code:
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(510) 240-6000
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Not Applicable
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(Former name or former address, if changed since last report)
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o |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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(d)
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Exhibits.
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Exhibit No.
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Description
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99.1
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Press release issued October 30, 2012.
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Dated: October 30, 2012 |
IMPAX LABORATORIES, INC.
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||
By:
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/s/ Larry Hsu, Ph.D. | ||
Name: Larry Hsu, Ph.D. | |||
Title: President and Chief Executive Officer |
Exhibit No.
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Description
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99.1
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Press release issued October 30, 2012.
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● |
Adjusted net income increased $15.3 million to $32.5 million in the third quarter 2012, or $0.48 per diluted share, compared to $17.2 million, or $0.26 per diluted share, in the prior year period. This increase was primarily driven by United States (U.S.) sales of Zomig® which was licensed from AstraZeneca pursuant to the previously disclosed January 2012 License Agreement. Adjusted results exclude acquisition-related costs, as well as other items noted below.
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● |
GAAP net income increased $2.8 million to $20.0 million in the third quarter 2012, or $0.29 per diluted share, compared to $17.2 million, or $0.26 per diluted share, in the prior year period.
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● |
Total revenues increased 21% to $145.6 million in the third quarter 2012, compared to $119.8 million in the prior year period, primarily due to U.S. sales of Zomig®. Partially offsetting this increase were lower generic Rx Partner and Research Partner revenues, as well as the completion in June 2012 of a three-year brand product promotional agreement for which there was no revenue recognized in the third quarter 2012 compared to the prior year period.
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● |
Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), increased to $56.6 million in the third quarter 2012, compared to $32.5 million in the prior year period.
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(unaudited, amounts in thousands)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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||||||||||||||
2012
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2011
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2012
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2011
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|||||||||||||
Revenues:
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||||||||||||||||
Global Product sales, net
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$ | 99,463 | $ | 97,661 | $ | 342,105 | $ | 301,124 | ||||||||
Rx Partner
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(792 | ) | 12,621 | 4,652 | 20,169 | |||||||||||
OTC Partner
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763 | 879 | 2,237 | 4,006 | ||||||||||||
Research Partner
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996 | 3,385 | 7,765 | 13,154 | ||||||||||||
Total revenues
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100,430 | 114,546 | 356,759 | 338,453 | ||||||||||||
Cost of revenues
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44,106 | 54,196 | 177,690 | 164,627 | ||||||||||||
Gross profit
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56,324 | 60,350 | 179,069 | 173,826 | ||||||||||||
Operating expenses:
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||||||||||||||||
Research and development
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12,392 | 11,487 | 35,190 | 34,728 | ||||||||||||
Patent litigation (recovery) expense
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(371 | ) | 2,114 | 6,581 | 6,097 | |||||||||||
Selling, general and administrative
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3,790 | 3,694 | 11,482 | 8,892 | ||||||||||||
Total operating expenses
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15,811 | 17,295 | 53,253 | 49,717 | ||||||||||||
Income from operations
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$ | 40,513 | $ | 43,055 | $ | 125,816 | $ | 124,109 |
(unaudited, amounts in thousands)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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||||||||||||||
2012
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2011
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2012
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2011
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|||||||||||||
Revenues:
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||||||||||||||||
Impax Product sales, net
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$ | 43,327 | $ | - | $ | 71,422 | $ | - | ||||||||
Rx Partner
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1,500 | 1,438 | 4,375 | 4,313 | ||||||||||||
Research Partner
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330 | 330 | 989 | 989 | ||||||||||||
Promotional Partner
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- | 3,535 | 7,070 | 10,605 | ||||||||||||
Total revenues
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45,157 | 5,303 | 83,856 | 15,907 | ||||||||||||
Cost of revenues
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23,454 | 2,999 | 44,522 | 8,840 | ||||||||||||
Gross profit
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21,703 | 2,304 | 39,334 | 7,067 | ||||||||||||
Operating expenses:
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||||||||||||||||
Research and development
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7,620 | 7,352 | 23,507 | 27,580 | ||||||||||||
Selling, general and administrative
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12,498 | 1,632 | 22,266 | 4,116 | ||||||||||||
Total operating expenses
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20,118 | 8,984 | 45,773 | 31,696 | ||||||||||||
Income (loss) from operations
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$ | 1,585 | $ | (6,680 | ) | $ | (6,439 | ) | $ | (24,629 | ) |
(unaudited, amounts in thousands)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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||||||||||||||
2012
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2011
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2012
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2011
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General and administrative expenses
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$ | 12,639 | $ | 10,992 | $ | 41,282 | $ | 35,398 | ||||||||
Loss from operations
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$ | (12,639 | ) | $ | (10,992 | ) | $ | (41,282 | ) | $ | (35,398 | ) |
● |
UPDATED - Total R&D expenses across the generic and brand divisions to approximate $86.0 million with generic R&D of approximately $48.0 million and brand R&D of approximately $38.0 million.
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● |
UPDATED - Patent litigation expenses of approximately $13.0 million. In the third quarter 2012, the Company received a $5.0 million patent litigation settlement reimbursement.
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● |
SG&A expenses of approximately $113.0 million.
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● |
Gross margins as a percent of total revenues of approximately 60%.
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● |
UPDATED - Effective tax rate of approximately 35%.
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● |
Capital expenditures of approximately $78.0 million.
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● |
With the recent additional competition on fenofibrate capsules and generic Adderall XR®, the Company expects its total revenues for the fourth quarter of 2012 to decline by approximately 15% to 20% from the third quarter of 2012.
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Three Months Ended September 30,
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Nine Months Ended September 30,
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|||||||||||||||
2012
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2011
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2012
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2011
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|||||||||||||
Revenues:
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||||||||||||||||
Global Pharmaceuticals Division
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$ | 100,430 | $ | 114,546 | $ | 356,759 | $ | 338,453 | ||||||||
Impax Pharmaceuticals Division
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45,157 | 5,303 | 83,856 | 15,907 | ||||||||||||
Total revenues
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145,587 | 119,849 | 440,615 | 354,360 | ||||||||||||
Cost of revenues
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67,560 | 57,195 | 222,212 | 173,467 | ||||||||||||
Gross profit
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78,027 | 62,654 | 218,403 | 180,893 | ||||||||||||
Operating expenses:
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||||||||||||||||
Research and development
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20,012 | 18,839 | 58,697 | 62,308 | ||||||||||||
Patent litigation (recovery) expense
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(371 | ) | 2,114 | 6,581 | 6,097 | |||||||||||
Selling, general and administrative
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28,927 | 16,318 | 75,030 | 48,406 | ||||||||||||
Total operating expenses
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48,568 | 37,271 | 140,308 | 116,811 | ||||||||||||
Income from operations
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29,459 | 25,383 | 78,095 | 64,082 | ||||||||||||
Other income (expense), net
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46 | 69 | (129 | ) | (470 | ) | ||||||||||
Interest income
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272 | 268 | 771 | 879 | ||||||||||||
Interest expense
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(145 | ) | (53 | ) | (607 | ) | (81 | ) | ||||||||
Income before income taxes
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29,632 | 25,667 | 78,130 | 64,410 | ||||||||||||
Provision for income taxes
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9,635 | 8,486 | 27,166 | 20,844 | ||||||||||||
Net income before noncontrolling interest
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19,997 | 17,181 | 50,964 | 43,566 | ||||||||||||
Add back loss attributable to noncontrolling interest
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40 | 39 | 110 | 67 | ||||||||||||
Net income
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$ | 20,037 | $ | 17,220 | $ | 51,074 | $ | 43,633 | ||||||||
Net income per share:
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Basic
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$ | 0.30 | $ | 0.27 | $ | 0.78 | $ | 0.68 | ||||||||
Diluted
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$ | 0.29 | $ | 0.26 | $ | 0.75 | $ | 0.65 | ||||||||
Weighted average common shares outstanding:
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Basic
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65,797,722 | 64,387,413 | 65,451,926 | 63,937,796 | ||||||||||||
Diluted
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68,366,849 | 66,986,758 | 68,230,487 | 67,318,658 |
September 30,
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December 31,
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|||||||
2012
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2011
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Assets
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Current assets:
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Cash and cash equivalents
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$ | 172,692 | $ | 104,419 | ||||
Short-term investments
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167,046 | 241,995 | ||||||
Accounts receivable, net
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97,770 | 153,773 | ||||||
Inventory, net
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78,674 | 54,177 | ||||||
Deferred tax asset
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43,170 | 37,853 | ||||||
Prepaid expenses and other assets
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24,040 | 7,718 | ||||||
Total current assets
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583,392 | 599,935 | ||||||
Property, plant and equipment, net
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171,126 | 118,158 | ||||||
Other assets
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64,941 | 45,942 | ||||||
Intangible assets, net
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54,172 | 2,250 | ||||||
Goodwill
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27,574 | 27,574 | ||||||
Total assets
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$ | 901,205 | $ | 793,859 | ||||
Liabilities and Stockholders' Equity
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Current liabilities:
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Accounts payable and accrued expenses
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$ | 121,742 | $ | 93,071 | ||||
Accrued profit sharing and royalty expenses
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9,159 | 40,766 | ||||||
Accrued product licensing payments
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40,000 | - | ||||||
Deferred revenue
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12,328 | 23,024 | ||||||
Total current liabilities
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183,229 | 156,861 | ||||||
Deferred revenue
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15,092 | 17,131 | ||||||
Other liabilities
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21,242 | 16,861 | ||||||
Total liabilities
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219,563 | $ | 190,853 | |||||
Total stockholders' equity
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681,642 | 603,006 | ||||||
Total liabilities and stockholders' equity
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$ | 901,205 | $ | 793,859 |
Nine Months Ended
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||||||||
September 30,
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||||||||
2012
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2011
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|||||||
Cash flows from operating activities:
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||||||||
Net income
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$ | 51,074 | $ | 43,633 | ||||
Adjustments to reconcile net income to net cash provided by operating activities:
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||||||||
Depreciation and amortization
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23,273 | 11,903 | ||||||
Accretion of interest income on short-term investments
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(473 | ) | (665 | ) | ||||
Recognition of deferred charge – Zomig® prepaid royalty
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24,997 | - | ||||||
In-process research and development charge
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1,550 | - | ||||||
Deferred income taxes
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(23,437 | ) | 4,464 | |||||
Tax benefit related to the exercise of employee stock options
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(3,515 | ) | (6,086 | ) | ||||
Deferred revenue
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1,738 | 2,182 | ||||||
Deferred product manufacturing costs
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(2,743 | ) | (1,275 | ) | ||||
Recognition of deferred revenue
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(16,236 | ) | (19,489 | ) | ||||
Amortization of deferred product manufacturing costs
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2,775 | 2,494 | ||||||
Accrued profit sharing and royalty expense
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67,427 | 67,210 | ||||||
Payments of profit sharing and royalty expense
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(99,034 | ) | (58,759 | ) | ||||
Share-based compensation expense
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12,146 | 9,632 | ||||||
Bad debt expense
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- | 163 | ||||||
Changes in certain assets and liabilities:
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||||||||
Accounts receivable
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56,003 | (24,112 | ) | |||||
Inventory
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(24,497 | ) | (5,577 | ) | ||||
Prepaid expenses and other assets
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47,446 | (9,606 | ) | |||||
Accounts payable and accrued expenses
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23,019 | (6,871 | ) | |||||
Other liabilities
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5,774 | 1,213 | ||||||
Net cash provided by operating activities
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147,287 | 10,454 | ||||||
Cash flows from investing activities:
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||||||||
Purchase of short-term investments
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(177,461 | ) | (280,602 | ) | ||||
Maturities of short-term investments
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252,883 | 316,277 | ||||||
Purchases of property, plant and equipment
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(58,618 | ) | (18,433 | ) | ||||
Payment for product licensing rights
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(111,000 | ) | - | |||||
Net cash (used in) provided by investing activities
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(94,196 | ) | 17,242 | |||||
Cash flows from financing activities:
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||||||||
Tax benefit related to the exercise of employee stock options and restricted stock
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3,515 | 6,086 | ||||||
Proceeds from exercise of stock options and ESPP
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11,667 | 12,632 | ||||||
Net cash provided by financing activities
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15,182 | 18,718 | ||||||
Net increase in cash and cash equivalents
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68,273 | 46,414 | ||||||
Cash and cash equivalents, beginning of period
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104,419 | 91,796 | ||||||
Cash and cash equivalents, end of period
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$ | 172,692 | $ | 138,210 |
(Unaudited, amounts in millions, except per share data)
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Three months ended September 30,
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Nine months ended September 30,
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||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
Net income
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$ | 20.0 | $ | 17.2 | $ | 51.1 | $ | 43.6 | ||||||||
Adjusted to add (deduct):
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||||||||||||||||
Amortization and acquisition-related costs(a)
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22.1 | - | 36.4 | - | ||||||||||||
Generic product withdrawal costs(b)
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2.0 | - | 2.0 | - | ||||||||||||
Patent litigation settlement reimbursement(c)
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(5.0 | ) | - | (5.0 | ) | - | ||||||||||
Gross profit earned on Zomig® Agreement
|
- | - | 46.2 | - | ||||||||||||
Acquisition related in process R&D
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- | - | 1.6 | - | ||||||||||||
Employee severance
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- | - | 1.9 | 0.8 | ||||||||||||
Inventory adjustment
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- | - | 3.5 | - | ||||||||||||
Lower of cost or market charge
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- | - | 1.7 | - | ||||||||||||
Income tax effect
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(6.6 | ) | - | (30.4 | ) | (0.3 | ) | |||||||||
Adjusted net income
|
$ | 32.5 | $ | 17.2 | $ | 109.0 | $ | 44.1 | ||||||||
Net income adjusted per diluted share
|
$ | 0.48 | $ | 0.26 | $ | 1.60 | $ | 0.66 | ||||||||
Net income per diluted share
|
$ | 0.29 | $ | 0.26 | $ | 0.75 | $ | 0.65 |
(Unaudited, amounts in millions)
|
Three months ended September 30,
|
Nine months ended September 30,
|
||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
Net income
|
$ | 20.0 | $ | 17.2 | $ | 51.1 | $ | 43.6 | ||||||||
Adjusted to add (deduct):
|
||||||||||||||||
Interest income
|
(0.3 | ) | (0.3 | ) | (0.8 | ) | (0.9 | ) | ||||||||
Interest expense
|
0.1 | 0.1 | 0.6 | 0.1 | ||||||||||||
Depreciation and other
|
4.3 | 3.5 | 11.9 | 11.9 | ||||||||||||
Income taxes
|
9.6 | 8.5 | 27.2 | 20.8 | ||||||||||||
EBITDA
|
33.7 | 29.0 | 90.0 | 75.5 | ||||||||||||
Adjusted to add:
|
||||||||||||||||
Amortization and acquisition-related costs(a)
|
22.1 | - | 36.4 | - | ||||||||||||
Generic product withdrawal costs(b)
|
2.0 | - | 2.0 | - | ||||||||||||
Patent litigation settlement reimbursement(c)
|
(5.0 | ) | - | (5.0 | ) | - | ||||||||||
Gross profit earned on Zomig® Agreement
|
- | - | 46.2 | - | ||||||||||||
Acquisition related in process R&D
|
- | - | 1.6 | - | ||||||||||||
Employee severance
|
- | - | 1.9 | 0.8 | ||||||||||||
Inventory adjustment
|
- | - | 3.5 | - | ||||||||||||
Lower of cost or market charge
|
- | - | 1.7 | - | ||||||||||||
Share-based compensation
|
3.8 | 3.5 | 12.1 | 9.6 | ||||||||||||
Adjusted EBITDA
|
$ | 56.6 | $ | 32.5 | $ | 190.4 | $ | 85.9 |
(a)
|
Amortization and acquisition-related costs from the January 2012 Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited and the June 2012 Development, Distribution and Supply Agreement with TOLMAR, Inc.
|
(b)
|
The Company recorded a charge of $2.0 million related to the voluntary withdrawal from the market of bupropion XL 300 mg, manufactured by Impax and marketed through our Strategic Alliance Agreement with Teva.
|
(c)
|
The Company received $5.0 million for reimbursement of legal fees pursuant to the settlement of litigation.
|
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