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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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33-0702205
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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PAGE
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·
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our expectations regarding the sales and marketing of our products, including our enoxaparin product;
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·
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our expectations regarding the integrity of our supply chain for our products, including the risks associated with our single source suppliers;
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·
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the timing and likelihood of FDA approvals and regulatory actions on our product candidates, manufacturing activities and product marketing activities;
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·
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our ability to advance product candidates in our platforms into successful and completed clinical trials and our subsequent ability to successfully commercialize our product candidates;
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·
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our ability to compete in the development and marketing of our products and product candidates;
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·
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the potential for adverse application of environmental, health and safety and other laws and regulations on our operations;
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·
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our expectations for market acceptance of our new products and proprietary drug delivery technologies;
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·
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the potential for our marketed products to be withdrawn due to patient adverse events or deaths, or if we fail to secure FDA approval for products subject to the Prescription Drug Wrap-Up program;
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·
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our expectations in obtaining insurance coverage and adequate reimbursement for our products from third-party payers;
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·
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the amount of price concessions or exclusion of suppliers adversely affecting our business;
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·
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our ability to establish and maintain intellectual property on our products and our ability to successfully defend these in cases of alleged infringement;
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·
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the implementations of our business strategies, product candidates and technology;
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·
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the potential for exposure to product liability claims;
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·
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future acquisitions or investments;
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·
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our ability to expand internationally;
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·
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economic and industry trends and trend analysis;
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·
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our ability to remain in compliance with laws and regulations that currently apply or become applicable to our business both in the United States and internationally; and
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·
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our financial performance expectations, including our expectations regarding our revenue, cost of revenue, gross profit or gross margin, operating expenses, including changes in research and development, sales and marketing and general and administrative expenses, and our ability to achieve and maintain future profitability.
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March 31, 2015
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December 31,
2014
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||||||
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ASSETS
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(unaudited)
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||||||
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Current Assets:
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|||||||
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Cash and cash equivalents
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$
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68,588
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$
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67,828
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Restricted cash and restricted short-term investments
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1,495
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1,495
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|||||
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Accounts receivable, net
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21,653
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22,852
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||||
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Inventories, net
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84,887
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82,332
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||||
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Income tax refund and deposits
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2,333
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273
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||||||
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Prepaid expenses and other assets
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3,934
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3,683
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|||||
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Deferred tax assets
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19,707
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19,533
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||||
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Total current assets
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202,597
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197,996
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||||
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Property, plant, and equipment, net
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138,276
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138,289
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||||
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Goodwill and intangible assets, net
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41,326
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42,565
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||||||
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Other assets
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4,447
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3,588
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||||
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Deferred tax assets
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9,856
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6,932
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||||
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||||||||
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Total assets
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$
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396,502
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$
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389,370
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||||||||
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LIABILITIES AND EQUITY
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|||||||
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Current Liabilities:
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|||||||
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Accounts payable
|
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$
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18,948
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$
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10,161
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Accrued liabilities
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14,663
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13,144
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||||||
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Income taxes payable
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3,000
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3,123
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||||
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Accrued payroll and related benefits
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13,864
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11,449
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||||||
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Current portion of product return accrual
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2,042
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1,918
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||||||
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Current portion of deferred revenue
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6,886
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14,013
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||||||
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Current portion of long-term debt and capital leases
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12,531
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7,594
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||||
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Current portion of deferred tax liabilities
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156
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1,193
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||||||
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Total current liabilities
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72,090
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62,595
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|||||
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|||||||
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Long-term product return accrual
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539
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490
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||||
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Long-term reserve for income tax liabilities
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1,046
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499
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||||||
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Long-term deferred revenue
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1,821
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1,982
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||||
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Long-term debt and capital leases, net of current portion
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35,886
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36,106
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||||
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Long-term deferred tax liabilities
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5,839
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5,838
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||||
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Total liabilities
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117,221
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107,510
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||||||
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Commitments and Contingencies:
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|||||||
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Stockholders’ equity:
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|||||||
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Preferred stock: par value $.0001; authorized shares—20,000,000; no shares issued and outstanding
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—
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—
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||||
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Common stock: par value $.0001; authorized shares—300,000,000; issued and outstanding shares—44,662,037 and 44,646,767 at March 31, 2015 and December 31, 2014, respectively
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4
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4
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||||
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Additional paid-in capital
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223,313
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220,745
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Retained earnings
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62,445
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63,110
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||||
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Accumulated other comprehensive loss
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(4,647
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)
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(1,654
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)
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||||
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Treasury stock
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(1,834
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)
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(345
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)
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|||
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Total stockholders’ equity
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279,281
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281,860
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||||
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||||||||
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Total liabilities and stockholders’ equity
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$
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396,502
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$
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389,370
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|||
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Three Months Ended
March 31,
|
||||||||
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2015
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2014
|
|||||||
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Net revenues
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$ | 56,886 | $ | 45,870 | ||||
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Cost of revenue
|
43,606 | 33,362 | ||||||
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Gross profit
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13,280 | 12,508 | ||||||
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Operating expenses:
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||||||||
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Selling, distribution, and marketing
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1,522 | 1,259 | ||||||
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General and administrative
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12,451 | 6,845 | ||||||
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Research and development
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6,568 | 6,209 | ||||||
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Impairment of long-lived assets
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— | 164 | ||||||
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Total operating expenses
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20,541 | 14,477 | ||||||
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Loss from operations
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(7,261 | ) | (1,969 | ) | ||||
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Non-operating income (expense):
|
||||||||
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Interest income
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92 | 28 | ||||||
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Interest expense
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(341 | ) | (180 | ) | ||||
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Other income (expense), net
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1,313 | (350 | ) | |||||
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Total non-operating income (expense), net
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1,064 | (502 | ) | |||||
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Loss before income taxes
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(6,197 | ) | (2,471 | ) | ||||
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Income tax benefit
|
(5,532 | ) | (852 | ) | ||||
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Net loss
|
$ | (665 | ) | $ | (1,619 | ) | ||
|
Net loss per common share:
|
||||||||
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Basic
|
$ | (0.01 | ) | $ | (0.04 | ) | ||
|
Diluted
|
$ | (0.01 | ) | $ | (0.04 | ) | ||
|
Weighted-average shares used to compute net loss per common share:
|
||||||||
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Basic
|
44,601 | 38,769 | ||||||
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Diluted
|
44,601 | 38,769 | ||||||
|
Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Net loss
|
$ | (665 | ) | $ | (1,619 | ) | ||
|
Accumulated other comprehensive loss
|
||||||||
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Foreign currency translation adjustment
|
(2,993 | ) | — | |||||
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Total accumulated other comprehensive loss
|
(2,993 | ) | — | |||||
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Total comprehensive loss
|
$ | (3,658 | ) | $ | (1,619 | ) | ||
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Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Cash Flows From Operating Activities:
|
||||||||
|
Net loss
|
$ | (665 | ) | $ | (1,619 | ) | ||
|
Reconciliation to net cash provided by (used in) operating activities:
|
||||||||
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Impairment of long-lived assets
|
— | 165 | ||||||
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Loss on disposal of property, plant, and equipment
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4 | — | ||||||
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Depreciation and amortization of property, plant, and equipment
|
2,771 | 2,940 | ||||||
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Amortization of product rights, trademarks, and patents
|
481 | 475 | ||||||
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Imputed interest accretion
|
28 | — | ||||||
|
Employee share-based compensation expense
|
2,224 | 1,380 | ||||||
|
Non-employee share-based compensation expense
|
6 | 236 | ||||||
|
Reserve for income tax liabilities
|
547 | — | ||||||
|
Changes in deferred taxes
|
(4,111 | ) | — | |||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable, net
|
621 | 5,471 | ||||||
|
Inventories, net
|
(4,486 | ) | (9,131 | ) | ||||
|
Income tax refund and deposits
|
— | (912 | ) | |||||
|
Prepaid expenses and other assets
|
(2,311 | ) | (1,052 | ) | ||||
|
Income taxes payable
|
(131 | ) | (177 | ) | ||||
|
Accounts payable and accrued liabilities
|
6,360 | (3,611 | ) | |||||
|
Net cash provided by (used in) operating activities
|
1,338 | (5,835 | ) | |||||
|
Cash Flows From Investing Activities:
|
||||||||
|
Purchases of property, plant, and equipment
|
(3,780 | ) | (4,030 | ) | ||||
|
Capitalized labor, overhead, and interest on self-constructed assets
|
(395 | ) | (196 | ) | ||||
|
Deposits and other assets, net
|
(870 | ) | (571 | ) | ||||
|
Net cash used in investing activities
|
(5,045 | ) | (4,797 | ) | ||||
|
Cash Flows From Financing Activities:
|
||||||||
|
Net proceeds from equity plans
|
910 | — | ||||||
|
Repurchase of common stock
|
(572 | ) | — | |||||
|
Deferred offering cost
|
— | (147 | ) | |||||
|
Payments on treasury stock
|
(1,489 | ) | — | |||||
|
Proceeds from borrowing under lines of credit
|
— | 25,000 | ||||||
|
Repayments under lines of credit
|
— | (15,000 | ) | |||||
|
Proceeds from issuance of long-term debt
|
6,789 | — | ||||||
|
Principal payments on long-term debt
|
(1,193 | ) | (673 | ) | ||||
|
Net cash provided by financing activities
|
4,445 | 9,180 | ||||||
|
Effect of exchange rate changes on cash
|
22 | — | ||||||
|
Net increase (decrease) in cash and cash equivalents
|
760 | (1,452 | ) | |||||
|
Cash and cash equivalents at beginning of period
|
67,828 | 53,587 | ||||||
|
Cash and cash equivalents at end of period
|
$ | 68,588 | $ | 52,135 | ||||
|
Noncash Investing and Financing Activities:
|
||||||||
|
Equipment acquired under capital leases
|
$ | 9 | $ | — | ||||
|
Supplemental Disclosures of Cash Flow Information:
|
||||||||
|
Interest paid
|
$ | 469 | $ | 209 | ||||
|
Income taxes paid
|
$ | — | $ | 79 | ||||
|
Euros
|
U.S.
Dollars
|
|||||||
|
(in thousands)
|
||||||||
|
At Closing, April 2014
|
€ | 13,252 | $ | 18,352 | ||||
|
December 2014
|
4,899 | 5,989 | ||||||
|
December 2015
|
3,186 | 3,457 | ||||||
|
December 2016
|
3,186 | 3,457 | ||||||
|
December 2017
|
500 | 543 | ||||||
| € | 25,023 | $ | 31,798 | |||||
|
Fair Value
|
||||||||
|
Euros
|
U.S.
Dollars
|
|||||||
|
(in thousands)
|
||||||||
|
Inventory
|
€ | 15,565 | $ | 21,554 | ||||
|
Real property
|
4,800 | 6,647 | ||||||
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Machinery & equipment
|
6,800 | 9,417 | ||||||
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Intangibles
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80 | 111 | ||||||
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Goodwill
|
3,155 | 4,369 | ||||||
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Total assets acquired
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€ | 30,400 | $ | 42,098 | ||||
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Accrued liabilities
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€ | 2,425 | $ | 3,358 | ||||
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Deferred tax liabilities
|
3,155 | 4,369 | ||||||
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Total liabilities assumed
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5,580 | 7,727 | ||||||
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Total fair value of consideration transferred
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€ | 24,820 | $ | 34,371 | ||||
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Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(in thousands,
except per share data)
|
||||||||
|
Net revenues
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$ | 56,886 | $ | 45,888 | ||||
|
Net loss
|
(665 | ) | (2,606 | ) | ||||
|
Diluted net loss per share
|
$ | (0.01 | ) | $ | (0.07 | ) | ||
|
Three Months Ended
March 31,
|
||||||||
| 2015 | 2014 | |||||||
| (in thousands) | ||||||||
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Beginning balance
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$ | 11,872 | $ | 18,104 | ||||
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Provision related to sales made in the current period
|
42,372 |
41,642
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||||||
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Credits issued to third parties
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(42,909 | ) | ( 47,427 | ) | ||||
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Ending balance
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$ | 11,335 | $ |
12,319
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||||
|
Three Months Ended
March 31
|
||||||||
| 2015 | 2014 | |||||||
|
(in thousands)
|
||||||||
|
Beginning balance
|
$ | 2,408 | $ | 4,592 | ||||
|
Provision for product returns
|
803 |
140
|
||||||
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Credits issued to third parties
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(630 | ) | ( 313 | ) | ||||
|
Ending balance
|
$ | 2,581 | $ |
4,419
|
||||
|
Three Months Ended
March 31,
|
||||||||
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2015
|
2014
|
|||||||
|
(in thousands, except per share data)
|
||||||||
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Basic and dilutive numerator:
|
||||||||
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Net loss
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$ | (665 | ) | $ | (1,619 | ) | ||
|
Denominator:
|
||||||||
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Common shares outstanding
|
44,601 | 38,766 | ||||||
|
Contingently issuable shares - vested DSUs
|
— | 3 | ||||||
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Weighted-average common shares outstanding—basic
|
44,601 | 38,769 | ||||||
|
Net effect of dilutive securities:
|
||||||||
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Stock options
|
— | — | ||||||
|
Contingently issuable shares – nonvested DSUs
|
— | — | ||||||
|
Weighted-average common shares outstanding—diluted
|
44,601 | 38,769 | ||||||
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Net loss per common share—basic
|
$ | (0.01 | ) | $ | (0.04 | ) | ||
|
Net loss per common share—diluted
|
$ | (0.01 | ) | $ | (0.04 | ) | ||
|
-
|
Finished pharmaceutical products
|
|
-
|
Active pharmaceutical ingredients, or API
|
|
Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Net revenues:
|
||||||||
|
Finished pharmaceutical
products
|
$ | 50,872 | $ | 45,870 | ||||
|
API
|
6,014 | — | ||||||
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Total net revenues
|
56,886 | 45,870 | ||||||
|
Gross Profit:
|
||||||||
|
Finished pharmaceutical
products
|
12,853 | 12,508 | ||||||
|
API
|
427 | — | ||||||
|
Total gross profit
|
13,280 | 12,508 | ||||||
|
Operating expenses
|
20,541 | 14,477 | ||||||
|
Loss from operations
|
(7,261 | ) | (1,969 | ) | ||||
|
Non-operating income (expenses)
|
1,064 | (502 | ) | |||||
|
Loss before income taxes
|
$ | (6,197 | ) | $ | (2,471 | ) | ||
|
Net Revenue
|
Long-Lived Assets
|
|||||||||||||||
|
Three Months Ended
March 31,
|
March 31,
|
December 31,
|
||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
U.S.
|
$ | 52,960 | $ | 45,870 | $ | 101,229 | $ | 102,313 | ||||||||
|
China
|
— | — | 24,797 | 22,170 | ||||||||||||
|
France
|
3,926 | — | 12,250 | 13,806 | ||||||||||||
|
Total
|
$ | 56,886 | $ | 45,870 | $ | 138,276 | $ | 138,289 | ||||||||
|
% of Total Accounts
Receivable
|
% of Net
Revenue
|
|||||||||||||||
|
March 31,
|
December 31, |
Three Months Ended
March 31,
|
||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Actavis, Inc.
|
16 | % | 18 | % | 23 | % | 30 | % | ||||||||
|
AmerisourceBergen
|
17 | % | 5 | % | 16 | % | 15 | % | ||||||||
|
Cardinal Health
|
19 | % | 15 | % | 18 | % | 15 | % | ||||||||
|
MannKind Corporation
|
— | 21 | % | 10 | % | — | ||||||||||
|
McKesson
|
20 | % | 13 | % | 19 | % | 28 | % | ||||||||
|
·
|
Level 1
– Inputs to measure fair value are based on quoted prices (unadjusted) in active markets on identical assets or liabilities;
|
|
·
|
Level 2 –
Inputs to measure fair value are based on the following: a) quoted prices in active markets on similar assets or liabilities, b) quoted prices for identical or similar instruments in inactive markets, or c) observable (other than quoted prices) or collaborated observable market data used in a pricing model from which the fair value is derived; and
|
|
·
|
Level 3
– Inputs to measure fair value are unobservable and the assets or liabilities have little, if any, market activity; these inputs reflect the Company’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities based on best information available in the circumstances.
|
|
Total
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
Significant Other Observable Inputs
(Level 2)
|
Significant
Unobservable Inputs
(Level 3)
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Cash equivalents:
|
||||||||||||||||
|
Money market accounts
|
$ | 43,085 | $ | 43,085 | $ | — | $ | — | ||||||||
|
Restricted short-term investments:
|
||||||||||||||||
|
Certificates of deposit
|
1,495 | 1,495 | — | — | ||||||||||||
|
Fair value measurement as of March 31, 2015
|
$ | 44,580 | $ | 44,580 | $ | — | $ | — | ||||||||
|
Cash equivalents:
|
||||||||||||||||
|
Money market accounts
|
$ | 42,994 | $ | 42,994 | $ | — | $ | — | ||||||||
|
Restricted short-term investments:
|
||||||||||||||||
|
Certificates of deposit
|
1,495 | 1,495 | — | — | ||||||||||||
|
Fair value measurement as of December 31, 2014
|
$ | 44,489 | $ | 44,489 | $ | — | $ | — | ||||||||
|
Weighted-Average Life (Years)
|
Original Cost
|
Accumulated Amortization
|
Net Book Value
|
|||||||||||
|
(in thousands)
|
||||||||||||||
|
Definite-lived intangible assets
|
||||||||||||||
|
Product rights
|
12 | $ | 27,134 | $ | 21,338 | $ | 5,796 | |||||||
|
Patents
|
10 | 293 | 85 | 208 | ||||||||||
|
Trademarks
|
11 | 19 | 14 | 5 | ||||||||||
|
Land-use rights
|
39 | 2,540 | 239 | 2,301 | ||||||||||
|
Other intangible assets
|
1 | 592 | 509 | 83 | ||||||||||
|
Subtotal
|
12 | 30,578 | 22,185 | 8,393 | ||||||||||
|
Indefinite-lived intangible assets
|
||||||||||||||
|
Trademark
|
* | 29,225 | — | 29,225 | ||||||||||
|
Goodwill
|
||||||||||||||
|
Finished pharmaceutical products
|
* | 280 | — | 280 | ||||||||||
|
API
|
* | 3,428 | — | 3,428 | ||||||||||
|
Subtotal
|
* | 32,933 | — | 32,933 | ||||||||||
|
As of March 31, 2015
|
* | $ | 63,511 | $ | 22,185 | $ | 41,326 | |||||||
|
Weighted-Average Life (Years)
|
Original Cost
|
Accumulated Amortization
|
Net Book Value
|
|||||||||||
|
(in thousands)
|
||||||||||||||
|
Definite-lived intangible assets
|
||||||||||||||
|
Product rights
|
12 | $ | 27,134 | $ | 20,896 | $ | 6,238 | |||||||
|
Patents
|
10 | 293 | 78 | 215 | ||||||||||
|
Trademarks
|
11 | 19 | 15 | 4 | ||||||||||
|
Land-use rights
|
39 | 2,540 | 221 | 2,319 | ||||||||||
|
Other intangible assets
|
1 | 602 | 505 | 97 | ||||||||||
|
Subtotal
|
12 | 30,588 | 21,715 | 8,873 | ||||||||||
|
Indefinite-lived intangible assets
|
||||||||||||||
|
Trademark
|
* | 29,225 | — | 29,225 | ||||||||||
|
Goodwill
|
||||||||||||||
|
Finished pharmaceutical products
|
* | 280 | — | 280 | ||||||||||
|
API
|
* | 4,187 | — | 4,187 | ||||||||||
|
Subtotal
|
* | 33,692 | — | 33,692 | ||||||||||
|
As of December 31, 2014
|
* | $ | 64,280 | $ | 21,715 | $ | 42,565 | |||||||
|
March 31,
2015
|
December 31, 2014
|
|||||||
|
(in thousands)
|
||||||||
|
Beginning balance
|
$ | 4,467 | $ | 280 | ||||
|
Goodwill related to acquisition of business
|
— | 4,369 | ||||||
|
Currency translation and other adjustments
|
(759 | ) | (182 | ) | ||||
|
Ending balance
|
$ | 3,708 | $ | 4,467 | ||||
|
March 31,
2015
|
December 31,
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Raw materials and supplies
|
$ | 45,590 | $ | 41,996 | ||||
|
Work in process
|
19,534 | 16,221 | ||||||
|
Finished goods
|
20,643 | 24,755 | ||||||
|
Total inventory
|
85,767 | 82,972 | ||||||
|
Less reserve for excess and obsolete inventories
|
(880 | ) | (640 | ) | ||||
|
Total inventory, net
|
$ | 84,887 | $ | 82,332 | ||||
|
March 31,
2015
|
December 31,
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Building
|
$ | 67,354 | $ | 67,760 | ||||
|
Leasehold improvements
|
24,106 | 23,960 | ||||||
|
Land
|
6,890 | 7,020 | ||||||
|
Machinery and equipment
|
104,250 | 104,819 | ||||||
|
Furniture, fixtures, and automobiles
|
12,360 | 12,213 | ||||||
|
Construction in progress
|
28,516 | 25,068 | ||||||
|
Total property, plant, and equipment
|
243,476 | 240,840 | ||||||
|
Less accumulated depreciation and amortization
|
(105,200 | ) | (102,551 | ) | ||||
|
Total property, plant, and equipment, net
|
$ | 138,276 | $ | 138,289 | ||||
|
March 31,
2015
|
December 31,
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Loans with East West Bank
|
||||||||
|
Mortgage payable due January 2016
|
$ | 3,847 | $ | 3,887 | ||||
|
Mortgage payable due September 2016
|
2,269 | 2,289 | ||||||
|
Line of credit facility due March 2016
|
— | — | ||||||
|
Equipment loan due April 2017
|
2,621 | 2,923 | ||||||
|
Equipment loan due January 2019
|
5,903 | — | ||||||
|
Loans with Cathay Bank
|
||||||||
|
Mortgage payable due April 2021
|
4,526 | 4,549 | ||||||
|
Revolving line of credit due May 2016
|
— | — | ||||||
|
Acquisition loan due April 2019
|
20,410 | 20,870 | ||||||
|
Loans with Seine-Normandie Water Agency
|
||||||||
|
French government loan 1 due March 2018
|
45 | — | ||||||
|
French government loan 2 due June 2020
|
153 | — | ||||||
|
French government loan 3 due July 2021
|
380 | — | ||||||
|
Payment obligation to Merck
|
7,307 | 8,160 | ||||||
|
Equipment under Capital Leases
|
956 | 1,022 | ||||||
|
Total debt and capital leases
|
48,417 | 43,700 | ||||||
|
Less current portion of long-term debt and capital leases
|
12,531 | 7,594 | ||||||
|
Long-term debt and capital leases, net of current portion
|
$ | 35,886 | $ | 36,106 | ||||
|
Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Loss before taxes
|
$ | (6,197 | ) | $ | (2,471 | ) | ||
|
Income tax benefit
|
(5,532 | ) | (852 | ) | ||||
|
Net loss
|
$ | (665 | ) | $ | (1,619 | ) | ||
|
Income tax benefit as a percentage of income before income taxes
|
(89.3 | )% | (34.5 | )% | ||||
|
Three Months Ended
March 31,
2015
|
||||
|
(in thousands)
|
||||
|
Stockholders’ equity as of December 31, 2014
|
$ | 281,860 | ||
|
Net loss
|
(665 | ) | ||
|
Accumulated other comprehensive loss
|
(2,993 | ) | ||
|
Repurchase of common stock
|
(572 | ) | ||
|
Exercise of stock options
|
910 | |||
|
Nonemployee share-based compensation expense
|
6 | |||
|
Employee share-based compensation expense
|
2,224 | |||
|
Treasury stock
|
(1,489 | ) | ||
|
Stockholders’ equity as of March 31, 2015
|
$ | 279,281 | ||
|
Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Average volatility
|
27.5 | % | 27.8 | % | ||||
|
Risk-free interest rate
|
1.3 | % | 1.3 | % | ||||
|
Weighted-average expected life in years
|
4.7 | 4.3 | ||||||
|
Dividend yield rate
|
0.0 | % | 0.0 | % | ||||
|
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value
(1)
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Outstanding as of December 31, 2014
|
11,371,891 | $ | 15.12 | |||||||||||||
|
Options granted
|
1,914,679 | 15.81 | ||||||||||||||
|
Options exercised
|
(74,817 | ) | 12.55 | |||||||||||||
|
Options cancelled
|
(4,020 | ) | 14.21 | |||||||||||||
|
Options expired
|
(27,305 | ) | 28.28 | |||||||||||||
|
Outstanding as of March 31, 2015
|
13,180,428 | $ | 15.21 | 4.78 | $ | 21,639 | ||||||||||
|
Exercisable as of March 31, 2015
|
6,594,669 | $ | 16.81 | 3.42 | $ | 10,654 | ||||||||||
|
|
(1)
|
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s common stock for those awards that have an exercise price below the estimated fair value at March 31, 2015.
|
|
Three Months Ended
March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(in thousands, except per share data)
|
||||||||
|
Weighted-average grant date fair value
|
$ | 3.53 | $ | 3.20 | ||||
|
Intrinsic value of options exercised
|
189 | — | ||||||
|
Cash received
|
910 | — | ||||||
|
Total fair value of the options vested during the year
|
1,423 | 526 | ||||||
|
Options
|
Weighted-Average
Grant Date
Fair Value
|
|||||||
|
Nonvested as of December 31, 2014
|
5,090,591 | $ | 3.34 | |||||
|
Options granted
|
1,914,679 | 3.53 | ||||||
|
Options vested
|
(415,491 | ) | 3.43 | |||||
|
Options forfeited
|
(4,020 | ) | 5.20 | |||||
|
Nonvested as of March 31, 2015
|
6,585,759 | 3.39 | ||||||
|
Total DSUs Issued
|
Total Fair Market
Value of DSUs Issued
as Compensation
(1)
|
|||||||
|
(in thousands)
|
||||||||
|
DSUs outstanding at December 31, 2014
|
503,010 | |||||||
|
DSUs granted
|
452,420 | $ | 6,764 | |||||
|
DSUs forfeited
|
(2,256 | ) | ||||||
|
Common stock delivered
|
(58,803 | ) | ||||||
|
DSUs surrendered for taxes
|
(37,052 | ) | ||||||
|
DSUs outstanding at March 31, 2015
|
857,319 | |||||||
|
(1)
|
The total fair market value is derived from the number of DSUs granted times the current stock price on the date of grant.
|
|
Three Months Ended March 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(in thousands)
|
||||||||
|
Cost of revenues
|
$ | 488 | $ | 293 | ||||
|
Operating expenses:
|
||||||||
|
Selling, distribution and marketing
|
40 | 21 | ||||||
|
General and administrative
|
1,490 | 1,176 | ||||||
|
Research and development
|
212 | 126 | ||||||
|
Total share-based compensation
|
$ | 2,230 | $ | 1,616 | ||||
|
Three Months Ended
March 31,
|
Change
|
|||||||||||||||
|
2015
|
2014
|
Dollars
|
%
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Net revenues
|
||||||||||||||||
|
Finished pharmaceutical products
|
||||||||||||||||
|
Enoxaparin
|
$ | 23,842 | $ | 26,071 | $ | (2,229 | ) | (9 | %) | |||||||
|
Other products
|
27,030 | 19,799 | 7,231 | 37 | % | |||||||||||
|
Total finished pharmaceutical products
|
$ | 50,872 | $ | 45,870 | $ | 5,002 | 11 | % | ||||||||
|
API
|
6,014 | — | 6,014 | 100 | % | |||||||||||
|
Total net revenues
|
$ | 56,886 | $ | 45,870 | $ | 11,016 | 24 | % | ||||||||
|
Cost of revenues
|
||||||||||||||||
|
Finished pharmaceutical products
|
$ | 38,019 | $ | 33,362 | $ | 4,657 | 14 | % | ||||||||
|
API
|
5,587 | — | 5,587 | 100 | % | |||||||||||
|
Total cost of revenues
|
$ | 43,606 | $ | 33,362 | $ | 10,244 | 31 | % | ||||||||
|
Gross profit
|
$ | 13,280 | $ | 12,508 | $ | 772 | 6 | % | ||||||||
|
as % of net revenues
|
23 | % | 27 | % | ||||||||||||
|
Three Months Ended
March 31,
|
Change
|
|||||||||||||||
|
2015
|
2014
|
Dollars
|
%
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Selling, distribution, and marketing
|
$ | 1,522 | $ | 1,259 | $ | 263 | $ | 21 | % | |||||||
|
General and administrative
|
12,451 | 6,845 | 5,606 | 82 | % | |||||||||||
|
Three Months Ended
March 31,
|
Change
|
|||||||||||||||
|
2015
|
2014
|
Dollars
|
%
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Research and development
|
$ | 6,568 | $ | 6,209 | $ | 359 | 6 | % | ||||||||
|
Three Months Ended
March 31,
|
Change
|
|||||||||||||||
|
2015
|
2014
|
Dollars
|
%
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Salaries and personnel-related expenses
|
$ | 3,018 | $ | 2,798 | $ | 220 | 8 | % | ||||||||
|
Pre-launch inventory
|
— | 683 | (683 | ) | (100 | %) | ||||||||||
|
Clinical trials
|
98 | — | 98 | 100 | % | |||||||||||
|
FDA fees
|
115 | — | 115 | 100 | % | |||||||||||
|
Testing, operating and lab supplies
|
1,555 | 1,135 | 420 | 37 | % | |||||||||||
|
Depreciation and amortization
|
1,008 | 717 | 291 | 41 | % | |||||||||||
|
Other expenses
|
774 | 876 | (102 | ) | (12 | %) | ||||||||||
|
Total research and development expenses
|
$ | 6,568 | $ | 6,209 | $ | 359 | 6 | % | ||||||||
|
Three Months Ended
March 31,
|
Change
|
|||||||||||||||
|
2015
|
2014
|
Dollars
|
%
|
|||||||||||||
|
(in thousands)
|
||||||||||||||||
|
Income tax benefit
|
$ | 5,532 | $ | 852 | $ | 4,680 | 549 | % | ||||||||
|
Effective tax rate
|
89 | % | 34 | % | ||||||||||||
|
Three Months Ended March 31,
2015
|
||||
|
(in thousands)
|
||||
|
Statement of Cash Flow Data:
|
||||
|
Net cash provided by (used in)
|
||||
|
Operating activities
|
$ | 1,338 | ||
|
Investing activities
|
(5,045 | ) | ||
|
Financing activities
|
4,445 | |||
|
Effect of exchange rate changes on cash
|
22 | |||
|
Net increase in cash and cash equivalents
|
$ | 760 | ||
|
March 31,
2015
|
December 31,
2014
|
Change
|
||||||||||
|
(in thousands)
|
||||||||||||
|
Short-term debt and current portion of long-term debt
|
$ | 12,531 | $ | 7,594 | $ | 4,937 | ||||||
|
Long-term debt
|
35,886 | 36,106 | (220 | ) | ||||||||
|
Total debt
|
$ | 48,417 | $ | 43,700 | $ | 4,717 | ||||||
|
(c)
|
Issuer Purchases of Equity Securities
|
|
Period
|
Total Number of Shares Purchased
(1)
|
Average Price Paid per Share
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs
|
||||||||||||
|
January 1 – January 31, 2015
|
58,500 | $ | 11.85 | 58,500 | — | |||||||||||
|
February 1 – February 28, 2015
|
28,800 | 12.77 | 28,800 | — | ||||||||||||
|
March 1 – March 31, 2015
|
29,000 | 14.65 | 29,000 | — | ||||||||||||
|
(1)
|
During the first quarter of 2015, we repurchased shares of our common stock as part of the $10.0 million share buyback program authorized by our Board of Directors in November 2014.
|
|
AMPHASTAR PHARMACEUTICALS, INC.
(Registrant)
|
||
|
By:
|
/s/ JACK Y. ZHANG
|
|
|
Jack Y. Zhang
|
||
|
Chief Executive Officer
(Principal Executive Officer)
|
|
AMPHASTAR PHARMACEUTICALS, INC.
(Registrant)
|
||
|
By:
|
/s/ WILLIAM J. PETERS
|
|
|
William J. Peters
|
||
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
Exhibit
No.
|
Description
|
|
|
31.1
|
Certification of Chief Executive Officer Pursuant to Rules 13a-14(a) Under the Securities Exchange Act of 1934.
|
|
|
31.2
|
Certification of Chief Financial Officer Pursuant to Rules 13a-14(a) Under the Securities Exchange Act of 1934.
|
|
|
32.1#
|
Certification of Chief Executive Officer Pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
32.2#
|
Certification of Chief Financial Officer Pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
101.INS
|
XBRL Instance Document.
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definitions Linkbase Document.
|
|
|
#
|
The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference.
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|