Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc. (Form: 10-Q, Received: 08/13/2014 16:17:38)
Table of Contents
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 10-Q
 
 
 
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2014
 
or
 
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from             to             
 
Commission file number 001-36509
 
 
AMPHASTAR PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
33-0702205
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
 
11570 6 th Street
Rancho Cucamonga, CA 91730
(Address of principal executive offices, including zip code)
 
(909) 980-9484
(Registrant’s telephone number, including area code)
 
 
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   ¨     No   x     
 
Indicate by check mark whether the Registrant (1) has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
¨
Accelerated filer
¨
       
Non-accelerated filer
x   (Do not check if a smaller reporting company)
Smaller reporting company
¨
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨     No   x
 
The number of shares outstanding of the Registrant’s only class of common stock as of August 8, 2014 was 44,644,159.
 
 
 
 
AMPHASTAR PHARMACEUTICALS, INC.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2014
 
Note About Forward-Looking Statements
 
Part I. FINANCIAL INFORMATION
 
   
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NOTE ABOUT FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains “forward-looking statements” that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking statements include, but are not limited to, statements about:
 
·
our expectations regarding the sales and marketing of our products, including our enoxaparin product;
 
·
our expectations regarding the integrity of our supply chain for our products, including the risks associated with our single source suppliers;
 
·
the timing and likelihood of FDA approvals and regulatory actions on our product candidates, manufacturing activities and product marketing activities;
 
·
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;
 
·
our ability to compete in the development and marketing of our products and product candidates;
 
·
the potential for adverse application of environmental, health and safety and other laws and regulations on our operations;
 
·
our expectations for market acceptance of our new products and proprietary drug delivery technologies;
 
·
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;
 
·
our expectations in obtaining insurance coverage and adequate reimbursement for our products from third-party payers;
 
·
the amount of price concessions or exclusion of suppliers adversely affecting our business;
 
·
our ability to establish and maintain intellectual property on our products and our ability to successfully defend these in cases of alleged infringement;
 
·
the implementations of our business strategies, product candidates and technology;
 
·
the potential for exposure to product liability claims;
 
·
our ability to expand internationally;
 
·
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
 
·
our financial performance expectations.
 
You should read this Quarterly Report and the documents that we reference elsewhere in this Quarterly Report completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks and uncertainties in greater detail in this Quarterly Report, particularly in Part II. Item 1A. “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report regardless of the time of delivery of this Quarterly Report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Quarterly Report.

Unless expressly indicated or the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Amphastar,” “Company,” “we,” “our,” and “us” refer to Amphastar Pharmaceuticals, Inc. and our subsidiaries, unless the context indicates otherwise.
 
 
PART I – FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS

AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; in thousands, except share data)
 
   
June 30,
 2014
   
December 31,
 2013
 
ASSETS
           
Current Assets:
           
Cash and cash equivalents
  $
64,081
    $ 53,587  
Restricted cash and restricted short-term investments
    1,495       1,325  
Accounts receivable, net
    18,598       24,585  
Inventories, net
    106,017       69,916  
Income tax refund and deposits
    4,241       2,429  
Prepaid expenses and other assets
    3,699       5,033  
Deferred tax assets
    16,096       16,096  
                 
Total current assets
    214,227       172,971  
Property, plant, and equipment, net
    133,991       116,619  
Goodwill and intangible assets, net
    39,330       40,163  
Other assets
    3,602       2,877  
Deferred tax assets
    6,118       6,118  
                 
Total assets
  $ 397,268     $ 338,748  
                 
LIABILITIES AND EQUITY
               
Current Liabilities:
               
Accounts payable
  $ 17,764     $ 20,380  
Accrued liabilities
    10,491       7,628  
Income taxes payable
    2,773       2,847  
Accrued payroll and related benefits
    10,846       9,161  
Current portion of product return accrual
    3,100       2,639  
Current portion of deferred revenue
    643       643  
Current portion of long-term debt and capital leases
    10,665       22,104  
 Total current liabilities
    56,282       65,402  
                 
Long-term product return accrual
    938       1,953  
Long-term deferred revenue
    2,303       2,625  
Long-term debt and capital leases, net of current portion
    42,850       10,069  
Deferred tax liabilities
    7,154       7,154  
                 
Total liabilities
    109,527       87,203  
Commitments and Contingencies:
               
Stockholders’ equity:
               
Preferred stock: par value $.0001; authorized shares—20,000,000; none issued
           
Common stock; par value $.0001; authorized shares—300,000,000; issued and outstanding shares—44,635,940 and 38,765,940 at June 30, 2014 and December 31, 2013, respectively
    4       4  
Additional paid-in capital
    216,995       177,732  
Retained earnings
    71,010       73,809  
Accumulated other comprehensive loss
    (268 )      
                 
Total stockholders’ equity
    287,741       251,545  
                 
Total liabilities and stockholders’ equity
  $ 397,268     $ 338,748  
 
 
See Accompanying Notes to Condensed Consolidated Financial Statements.
 
 
- 1 -

 
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share data)
 
   
Three Months Ended
June 30,
   
Six Months Ended
 June 30,
 
   
2014
   
2013
   
2014
   
2013
 
Net revenues
  $ 49,003     $ 62,524     $ 94,873     $ 115,487  
Cost of revenue
    34,007       35,035       67,368       68,440  
                                 
Gross profit
    14,996       27,489       27,505       47,047  
                                 
Operating expenses:
                               
Selling, distribution, and marketing
    1,352       1,203       2,612       2,597  
General and administrative
    8,638       6,513       15,484       13,420  
Research and development
    5,994       7,791       12,203       16,695  
Impairment of long-lived assets
    184             348        
                                 
Total operating expenses
    16,168       15,507       30,647       32,712  
                                 
Income (loss) from operations
    (1,172 )     11,982       (3,142 )     14,335  
                                 
Non-operating income (expense):
                               
Interest income
    32       47       60       96  
Interest expense, net
    (476 )     (237 )     (655 )     (542 )
Other income (expense), net
    (260 )     127       (610 )     222  
                                 
Total other income (expense), net
    (704 )     (63 )     (1,205 )     (224 )
                                 
Income (loss) before income taxes
    (1,876 )     11,919       (4,347 )     14,111  
Income tax expense (benefit)
    (696 )     4,109       (1,548 )     3,919  
                                 
Net income (loss)
  $ (1,180 )   $ 7,810     $ (2,799 )   $ 10,192  
                                 
Net income (loss) per common share:
                               
Basic
  $ (0.03 )   $ 0.20     $ (0.07 )   $ 0.26  
                                 
Diluted
  $ (0.03 )   $ 0.20     $ (0.07 )   $ 0.26  
                                 
Weighted-average shares used to compute net income (loss) per common share:
                               
Basic
    39,767       38,708       39,268       38,708  
                                 
Diluted
    39,767       38,847       39,268       38,846  
 
 
See Accompanying Notes to Condensed Consolidated Financial Statements.

AMPHASTAR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited; in thousands, except per share data)
 
   
Three Months Ended
June 30,
   
Six Months Ended
 June 30,
 
   
2014
   
2013
   
2014
   
2013
 
Net income (loss)
  $ (1,180 )   $ 7,810     $ (2,799 )   $ 10,192  
                                 
Other comprehensive loss
                               
      Foreign currency translation adjustment
    (268 )           (268 )      
Other comprehensive loss
    (268 )           (268 )      
                                 
Total comprehensive income (loss)
  $ (1,448 )   $ 7,810     $ (3,067 )   $ 10,192  

 
See Accompanying Notes to Condensed Consolidated Financial Statements.

 
- 3 -

 
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
 
                 
 
  
Six Months Ended
 June 30,
 
 
  
2014
   
2013
 
Cash Flows From Operating Activities:
  
             
Net income (loss)
  
$
(2,799
)
 
$
10,192
 
 
  
             
Reconciliation to net cash provided by (used in) operating activities:
  
             
Impairment of long-lived assets
  
 
348
     
 
Loss on disposal of property, plant, and equipment
  
 
44
     
32
 
Depreciation and amortization of property, plant, and equipment
  
 
6,036
     
5,397
 
Amortization of product rights, trademarks, and patents
  
 
956
     
950
 
Employee share-based compensation expense
  
 
3,546
     
2,348
 
Non-employee share-based compensation expense
  
 
475
     
474
 
Reserve for income tax liabilities
  
 
     
62
 
Changes in operating assets and liabilities:
  
             
Accounts receivable, net
  
 
5,987
     
4,327
 
Inventories, net
  
 
(14,788
)
   
(3,256
)
Income tax refund and deposits
  
 
(1,812
)
   
(3
)
Prepaid expenses and other assets
  
 
(93
)
   
744
 
Income taxes payable
  
 
(74
)
   
3,328
 
Accounts payable and accrued liabilities
  
 
(2,727
)
   
(2,774
)
 
  
             
Net cash provided by (used in) operating activities
  
 
(4,901
)
   
21,821
 
 
  
             
Cash Flows From Investing Activities:
  
             
Acquisition of business
   
(18,352
)
   
 
Purchases of property, plant, and equipment
  
 
(7,090
)
   
(9,545
)
Capitalized labor, overhead, and interest on self-constructed assets
  
 
(364
)
   
(330
)
Purchase of trademarks and other intangible assets
   
     
(28
)
Sales of short-term investments, net
  
 
     
513
 
Decrease (increase) in restricted cash
  
 
(170
)
   
50
 
Deposits and other assets, net
  
 
(739
)
   
(711
)
 
  
             
Net cash used in investing activities
  
 
(26,715
)
   
(10,051
)
 
  
             
Cash Flows From Financing Activities:
  
             
Net proceeds from issuance of common stock
   
38,018
     
 
Net proceeds from exercise of common stock options
  
 
571
     
13
 
Costs related to public offering
  
 
(1,920
)
   
 
Deferred offering cost
   
     
(168
)
Proceeds from borrowing under lines of credit
  
 
25,000
     
35,000
 
Repayments under lines of credit
   
(40,000
)
   
(40,000
)
Proceeds from issuance of long-term debt
   
26,505
     
 
Principal payments on long-term debt
  
 
(6,032
)
   
(874
)
 
  
             
Net cash provided by (used in) financing activities
  
 
42,142
     
(6,029
)
 
  
             
Effect of exchange rate changes on cash
   
(32
)
   
 
                 
Net increase in cash and cash equivalents
   
10,494
     
5,741
 
                 
Cash and cash equivalents at beginning of period
  
 
53,587
     
50,213
 
 
  
             
Cash and cash equivalents at end of period
  
$
64,081
   
$
55,954
 
 
  
             
Noncash Investing and Financing Activities:
               
Equipment acquired under capital leases
 
$
   
$
44
 
                 
Supplemental Disclosures of Cash Flow Information:
               
Interest paid
 
$
573
   
$
607
 
Income taxes paid
 
$
84
   
$
75
 

 
See Accompanying Notes to Condensed Consolidated Financial Statements.
 

AMPHASTAR PHARMACEUTICALS, INC.
(Unaudited)
 
1.   General

Amphastar Pharmaceuticals, Inc., a California corporation, was incorporated on February 29, 1996 and merged with and into Amphastar Pharmaceuticals, Inc., a Delaware corporation, in July 2004 (hereinafter referred to as “the Company”). The Company is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation products, including products with high technical barriers to market entry. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s inhalation products will be primarily distributed through drug retailers once they are brought to market.

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2013 and the notes thereto as filed with the Securities and Exchange Commission in the Company’s final prospectus for its initial public offering, or IPO, filed with the SEC pursuant to Rule 424(b) on June 25, 2014. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair statement of the Company’s consolidated financial position, results of operations, and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods.
 
2.  Summary of Significant Accounting Policies

Basis of Presentation

All significant intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. The unaudited condensed consolidated financial statements have been prepared in accordance with the requirements of Form 10-Q and Rule 10-01 of Regulation S-X. Some information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted pursuant to those rules and regulations. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company.

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: International Medication Systems, Limited, or IMS; Amphastar Laboratories, Inc.; Armstrong Pharmaceuticals, Inc., or Armstrong; Amphastar Nanjing Pharmaceuticals Co., Ltd., or ANP; and Amphastar France Pharmaceuticals, SAS, or AFP.

Use of Estimates

The preparation of consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for doubtful accounts and discounts, liabilities for product returns and chargebacks, reserves for excess or unsellable inventory, impairment of long-lived and intangible assets and goodwill, self-insured claims, workers’ compensation liabilities, litigation reserves, stock price volatilities for share-based compensation expense, fair market values of the Company’s common stock, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions.

Foreign Currency

The functional currency of the Company and its domestic and Chinese subsidiaries is the U.S. dollar, or USD.  The Company’s Chinese subsidiary, ANP, maintains its books of record in Chinese Yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign exchange gains and losses are reflected in the Company’s statement of operations.  The Company’s French subsidiary, AFP, maintains its books of record in Euros, which is the local currency in France and has been determined to be its functional currency. These books are translated to USD at the average exchange rates during the period.  Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date.  Equity is translated at the prevailing rate of exchange at the date of the equity transactions.  Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive income (loss).  Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure.

Comprehensive Income (Loss)

For the three and six months ended June 30, 2014, the Company includes its foreign currency translation adjustment as part of its comprehensive loss as a result of the acquisition of Merck, Sharpe & Dohme’s, or Merck’s, Active Pharmaceutical Ingredient, or API, manufacturing business in Éragny-sur-Epte, France in April 2014 (see Note 3).  For the three and six months ended June 30, 2013, net income equaled comprehensive income.

Financial Instruments

The carrying amounts of cash and cash equivalents, short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. A majority of the Company’s long-term obligations consist of variable rate debt and their carrying value approximates fair value. Their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. However, the Company has one fixed-rate, long-term mortgage for which the carrying value differs from the fair value and is not remeasured on a recurring basis (see Note 13).

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO  CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Deferred Income Taxes
 
The Company utilizes the liability method of accounting for income taxes. Under the liability method, deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. The Company has adopted the with-and-without methodology for determining when excess tax benefits from the exercise of share-based awards are realized. Under the with-and-without methodology, current year operating loss deductions and prior-year operating loss carryforwards are deemed to be utilized prior to the utilization of current-year excess tax benefits from share-based awards.

Business Combinations

Business combinations are accounted for in accordance with Accounting Standards Codification, or ASC 805, Business Combinations, using the acquisition method of accounting. The acquisition method of accounting requires an acquirer to recognize the assets acquired and the liabilities assumed at the acquisition date measured at their fair values as of that date. Fair value determinations are based on discounted cash flow analyses or other valuation techniques. In determining the fair value of the assets acquired and liabilities assumed in a material acquisition, the Company may utilize appraisals from third party valuation firms to determine fair values of some or all of the assets acquired and liabilities assumed, or may complete some or all of the valuations internally. In either case, the Company takes full responsibility for the determination of the fair value of the assets acquired and liabilities assumed. The value of goodwill reflects the excess of the fair value of the consideration conveyed to the seller over the fair value of the net assets received. Under the acquisition method of accounting, the Company will identify the acquirer and the closing date and apply applicable recognition principles and conditions.

Acquisition-related costs are costs the Company incurs to effect a business combination. The Company accounts for acquisition-related costs as expenses in the periods in which the costs are incurred.

Recent Accounting Pronouncements

In July 2013, the Financial Accounting Standards Board, or FASB, issued an Accounting Standard Update to the accounting guidance to address the diversity in practice related to the financial statement presentation of unrecognized tax benefits as either a reduction of a deferred tax asset or a liability when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. This guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.

In April 2014, the FASB issued an accounting standards update that raises the threshold for disposals to qualify as discontinued operations and allows companies to have significant continuing involvement with and continuing cash flows from or to the discontinued operation. It also requires additional disclosures for discontinued operations and new disclosures for individually material disposal transactions that do not meet the definition of a discontinued operation. This guidance will be effective for fiscal years beginning after December 15, 2014, which will be the Company's fiscal year 2015, with early adoption permitted. The Company does not expect the adoption of the guidance will have a material impact on the Company's consolidated financial statements.

In May 2014, the FASB issued an accounting standards update that creates a single source of revenue guidance for companies in all industries. The new standard provides guidance for all revenue arising from contracts with customers and affects all entities that enter into contracts to provide goods or services to their customers, unless the contracts are within the scope of other accounting standards. It also provides a model for the measurement and recognition of gains and losses on the sale of certain nonfinancial assets. This guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach and will be effective for fiscal years beginning after December 15, 2016, which will be the Company's fiscal year 2017. The Company has not yet evaluated the potential impact of adopting the guidance on the Company's consolidated financial statements.

In June 2014, the FASB issued an accounting standards update that requires a performance target that affects vesting of a share-based payment award and that could be achieved after the requisite service period to be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation cost should be recognized over the required service period, if it is probable that the performance target will be achieved. This guidance will be effective for fiscal years beginning after December 15, 2015, which will be the Company's fiscal year 2016, with early adoption permitted. The Company does not expect the adoption of the guidance will have a material impact on the Company's consolidated financial statements.

3.  Business Acquisition

Acquisition of Merck Sharpe & Dohme’s API Manufacturing Business
 
On April 30, 2014, the Company completed its acquisition of Merck Sharpe & Dohme’s, or Merck’s, API manufacturing business in Éragny-sur-Epte, France, which manufactures porcine insulin API and recombinant human insulin API. The purchase price of the transaction on April 30, 2014 totaled €24.8 million, or $34.4 million, subject to certain customary post-closing adjustments and currency exchange fluctuations. The terms of the purchase include multiple payments over four years as follows (see Note 13):
 
 
   
Euros
   
U.S.
Dollars
 
   
(in thousands)
 
At Closing, April 2014
  13,252     $ 18,352  
December 2014
    4,899       6,708  
December 2015
    3,186       4,363  
December 2016
    3,186       4,363  
December 2017
    500       685  
    25,023     $ 34,471  
 
 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
In order to facilitate the acquisition, the Company established a subsidiary in France, Amphastar France Pharmaceuticals, SAS, or AFP. The Company will continue the current site manufacturing activities, which consist of the manufacturing of porcine insulin API and recombinant human insulin API. As part of the transaction, the Company has entered into various additional agreements, including various supply agreements, as well as the assignment and licensing of patents under which Merck was operating at this facility. In addition, certain existing customer agreements have been assigned to AFP.

Prior to the Company’s purchase of Merck’s facility in Éragny-sur-Epte, France, Merck notified the Company of several items it had identified as part of its own internal auditing that relate to potential minor environmental issues.  The Company understands from Merck that it identified these items because the items were not in alignment with Merck’s own internal policies and procedures, and not because any of the items are in violation of any French environmental law or regulation.  Under a letter of understanding, or LOU, dated April 30, 2014, Merck has agreed to pay for the remediation costs up to certain dollar limits, and to date, all estimates suggest the cost of conducting the remediation will be less than those dollar limits.  The LOU also includes an indemnification provision that would require the Company to indemnify Merck for liability that might arise from performance of the remediation work itself but not for other types of liability.

The transaction will be accounted for as a business combination in accordance to ASC 805. The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:

   
Fair Value
 
   
Euros
   
U.S.
Dollars
 
   
(in thousands)
 
Inventory
  15,565     $ 21,554  
Real property
    4,800       6,647  
Machinery & equipment
    6,800       9,417  
Intangibles
    80       111  
Total assets acquired
  27,245     $ 37,729  
                 
Accrued liabilities
  2,425     $ 3,358  
                 
Total fair value of consideration transferred
  24,820     $ 34,371  
 
The Company’s accounting for this acquisition is preliminary.  The fair value estimates for the assets acquired and liabilities assumed were based upon preliminary calculations and valuations, and the Company’s estimates and assumptions are subject to change as the Company obtains additional information for its estimates during the measurement period (up to one year from the acquisition date) including the completion of our analysis to determine the acquisition date fair values of certain tax-related items and residual impact on purchase accounting.  The operations of the acquired business have been included in the Company’s condensed consolidated financial statements commencing on the acquisition date. The results of operations for this acquisition have not been separately presented because this acquisition is not material to the Company’s condensed consolidated results of operations.

The following unaudited pro forma financial information for the six months ended June 30, 2014 and 2013 gives effect to the transaction as if it had occurred on January 1, 2013.  Such unaudited pro forma information is based on historical financial information with respect to the transaction and does not reflect operational and administrative cost savings, or synergies, that management of the combined company estimates may be achieved as a result of the transaction.  The unaudited pro forma information primarily reflects the additional depreciation related to the fair value adjustment to property, plant and equipment acquired, valuation step up related to the fair value of inventory and additional interest expense associated with the financing obtained by the Company in connection with the acquisition.
 
   
Six Months Ended
June 30,
 
   
2014
   
2013
 
   
(in thousands,
except per share data)
 
Net revenues
  $
97,157
    $ 122,436  
Net income (loss)
    ( 4,028 )    
10,709
 
Diluted net income (loss) per share
  $ (0.10 )   $
0.28
 

Acquisition Loan with Cathay Bank 
 
On April 22, 2014, in conjunction with the Company’s acquisition of Merck’s API manufacturing business in Éragny-sur-Epte, France, the Company entered into a secured term loan with Cathay Bank as lender. The principal amount of the loan is $21.9 million and bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00%. Beginning on June 1, 2014 and through the maturity date, April 22, 2019, the Company must make monthly payments of principal and interest based on the then outstanding amount of the loan amortized over a 120-month period. On April 22, 2019, all amounts outstanding under the loan become due and payable, which would be approximately $12.0 million based upon an interest rate of 4.00%. The loan is secured by 65% of the issued and outstanding shares of stock in AFP and certain assets of the Company, including accounts receivable, inventory, certain investment property, goods, deposit accounts, and general intangibles but not including the Company’s equipment and real property.

The loan includes customary restrictions on, among other things, the Company’s ability to incur additional indebtedness, pay dividends in cash or make other distributions in cash, make certain investments, create liens, sell assets, and make loans. The loan also includes customary events of defaults, the occurrence and continuation of any of which provide Cathay Bank the right to exercise remedies against the Company and the collateral securing the loan. These events of default include, among other things, the Company’s failure to pay any amounts due under the loan, the Company’s insolvency, the occurrence of any default under certain other indebtedness or material agreements, and a final judgment against the Company that is not discharged in 30 days.

4.  Revenue Recognition

Generally, revenue is recognized at the time of product delivery to the Company’s customers. In some cases, revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements. The Company also records profit-sharing revenue stemming from a distribution agreement with Actavis, Inc., or Actavis (see Note 16). Profit-sharing revenue is recognized at the time Actavis sells the products to its customers. Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers, after the customer has accepted test samples of the products to be shipped.
 
  AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
The Company does not recognize product revenue unless the following fundamental criteria are met: (i) persuasive evidence of an arrangement exists, (ii) transfer of title has occurred, (iii) the price to the customer is fixed or determinable, and (iv) collection is reasonably assured. Furthermore, the Company does not recognize revenue until all customer acceptance requirements have been met. The Company estimates and records reductions to revenue for discounts, product returns, and pricing adjustments, such as wholesaler chargebacks, in the same period that the related revenue is recorded.

The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of accounting. Revenues are recognized for each unit of accounting based on revenue recognition criteria relevant to that unit. The Company does not have any revenue arrangements with multiple deliverables.

Provision for Wholesaler Chargebacks

The provision for chargebacks is a significant estimate used in the recognition of revenue. As part of its sales terms with wholesale customers, the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products at the time wholesalers resell them under the Company’s various contractual arrangements with third parties such as hospitals and group purchasing organizations. The Company estimates chargebacks at the time of sale to wholesalers based on wholesaler inventory stocking levels, historic chargeback rates, and current contract pricing.

The provision for chargebacks is reflected in net revenues and a reduction to accounts receivables.  The following table is an analysis of the chargeback provision:
 
   
Six Months Ended
June 30,
2014
   
Year Ended
December 31,
2013
 
   
(in thousands)
 
Beginning balance
  $ 18,104     $ 11,898  
Provision related to sales made in the current period
    78,890       213,075  
Credits issued to third parties
    (87,393 )     (206,869 )
Ending balance
  $ 9,601     $ 18,104  
 
Changes in chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by the wholesalers, and on the wholesaler customer mix. The approach that the Company uses to estimate chargebacks has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and makes adjustments when it believes that the actual chargebacks may differ from the estimates. The settlement of chargebacks generally occurs within 30 days after the sale to wholesalers.

Accrual for Product Returns

The Company offers most customers the right to return qualified excess or expired inventory for partial credit; however, products sold to Actavis are non-returnable.  The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods.  Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for estimated returns. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and the introduction of new competition.  Although these factors do not normally give the Company’s customers the right to return products outside of the regular return policy, the Company realizes that such factors could ultimately lead to increased returns. The Company analyzes these situations on a case-by-case basis and makes adjustments to the product return reserve as appropriate.

The provision for product returns is reflected in net revenues.  The following table is an analysis of product return liability:
 
   
Six Months Ended
June 30,
2014
   
Year Ended
December 31,
2013
 
   
(in thousands)
 
Beginning balance
  $ 4,592     $ 2,673  
Provision for product returns
    191       2,711  
Credits issued to third parties
    (745 )     (792 )
Ending balance
  $ 4,038     $ 4,592  
 
For the six months ended June 30, 2014 and for the year ended December 31, 2013, the Company’s aggregate product return rate was 1.2% and 1.4% of qualified sales, respectively.

If the product return provision percentage were to increase by 0.1% of qualified sales, then an additional provision of $1.0 million and $0.9 million would result for the six months ended June 30, 2014 and the year ended December 31, 2013, respectively.

5.  Income (Loss) per Share

Basic income (loss) per share is calculated based upon the weighted-average number of common shares outstanding during the period and contingently issuable shares such as fully vested deferred stock units, or DSUs, as of the date all necessary conditions for issuance have been met. Diluted income per share gives effect to all potential dilutive common shares outstanding during the period, such as stock options and nonvested DSUs.
 
 
  AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
As the Company reported a net loss for the three and six months ended June 30, 2014, the diluted net loss per share, as reported, is equal to the basic net loss per share since the effect of the assumed exercise of stock options and conversion of nonvested DSUs is anti-dilutive. Total stock options and nonvested DSUs excluded from the three and six months ended June 30, 2014, net loss per share were 12,309,229 and 510,699, respectively.

For the three and six months ended June 30, 2013, options to purchase 6,934,338 and 7,182,004 shares of common stock with a weighted-average exercise price of $19.35 and $19.05 per share, respectively, were excluded in the computation of diluted net income per share because the effect from the assumed exercise of these options would be anti-dilutive.

The following table provides the calculation of basic and diluted net income (loss) per common share for each of the periods presented:

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2014
   
2013
   
2014
   
2013
 
   
(in thousands, except per share data)
 
Basic and dilutive numerator:
                       
Net income (loss)
  $ (1,180 )   $ 7,810     $ (2,799 )   $ 10,192  
                                 
Denominator:
                               
Common shares outstanding
    39,764       38,706       39,265       38,696  
Contingently issuable shares - vested DSUs
    3       2       3       12  
Weighted-average common shares outstanding—basic
    39,767       38,708       39,268       38,708  
                                 
Net effect of dilutive securities:
                               
Stock options
          63             57  
Contingently issuable shares – nonvested DSUs
          76             81  
Weighted-average common shares outstanding—diluted
    39,767       38,847       39,268       38,846  
Net income (loss) per common share—basic
  $ (0.03 )   $ 0.20     $ (0.07 )   $ 0.26  
Net income (loss) per common share—diluted
  $ (0.03 )   $ 0.20     $ (0.07 )   $ 0.26  

6.  Segment Reporting

The Company’s business is the development, manufacture, and marketing of pharmaceutical products. The Company has determined that all of its product groups have similar economic characteristics and may be aggregated into a single operational segment for reporting purposes.

Net revenues and carrying values of long-lived assets of enterprises by geographic regions are as follows:
 
   
Net Revenue
   
Net Revenue
   
Long-Lived
Assets
 
                   
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
   
June 30,
   
December 31,
 
   
2014
   
2013
   
2014
   
2013
   
2014
   
2013
 
   
(in thousands)
 
U.S.
  $ 48,901     $ 62,524     $ 94,771     $ 115,487     $ 98,262     $ 99,398  
China
                            20,029       17,221  
France
    102             102             15,700        
Total
  $ 49,003     $ 62,524     $ 94,873     $ 115,487     $ 133,991     $ 116,619  

7.  Customer and Supplier Concentration

Customer Concentrations
 
Three large wholesale drug distributors, AmerisourceBergen Corporation, or AmerisourceBergen, Cardinal Health, Inc. or Cardinal, and McKesson Corporation, or McKesson, are all distributors of the Company’s products, as well as suppliers of a broad range of health care products. Actavis, Inc., has exclusive marketing rights of the Company’s enoxaparin product to the U.S. retail pharmacy market. These four customers individually and collectively represented a significant percentage of the Company’s net revenue for the three and six months ended June 30, 2014 and 2013 and accounts receivable as of June 30, 2014 and December 31, 2013.
 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
The following table provides accounts receivable and net revenues information for the Company’s major customers:

   
% of Total Accounts
Receivable
   
% of Net
Revenue
   
% of Net
Revenue
 
                   
   
June 30,
   
December 31,
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2014
   
2013
   
2014
   
2013
   
2014
   
2013
 
Actavis, Inc.
    45 %     44 %     35 %     37 %     33 %     35 %
AmerisourceBergen
    5 %     11 %     16 %     14 %     16 %     14 %
Cardinal Health
    15 %     7 %     14 %     14 %     15 %     14 %
McKesson
    13 %     13 %     22 %     25 %     25 %     25 %

The Company’s products are primarily sold in U.S. domestic markets. For the three and six months ended June 30, 2014 and 2013, foreign sales were minimal, therefore, the Company has little exposure to foreign currency price fluctuations on its sales and accounts receivable.

Supplier Concentrations

The Company depends on suppliers for raw materials, active pharmaceutical ingredients, and other components that are subject to stringent U.S. Food and Drug Administration, or FDA, requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations.

8.  Fair Value Measurements

The accounting standards of the Financial Accounting Standards Board, or FASB, define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability at the measurement date (an exit price). These standards also establish a hierarchy that prioritizes observable and unobservable inputs used in measuring fair value of an asset or liability, as described below:

·
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.

The Company measures fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The Company classifies its cash equivalents and short-term investments as Level 1 assets, as they are valued on a recurring basis using quoted market prices with no valuation adjustments applied. The Company does not hold any Level 2 or Level 3 instruments that are measured for fair value on a recurring basis.

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
The fair values of the Company’s financial assets and liabilities measured on a recurring basis, as of June 30, 2014 and December 31, 2013, are as follows:

   
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
  $ 44,100     $ 44,100     $     $  
Restricted short-term investments:
                               
Certificates of deposit
    1,495       1,495              
                                 
Fair value measurement as of June 30, 2014
  $ 45,595     $ 45,595     $     $  
                                 
Cash equivalents:
                               
Money market accounts
  $ 41,183     $ 41,183     $     $  
Restricted short-term investments:
                               
Certificates of deposit
    1,325       1,325              
                                 
Fair value measurement as of December 31, 2013
  $ 42,508     $ 42,508     $     $  
 
The fair value of the Company’s cash equivalents includes money market funds and certificates of deposit with maturities of one year or less. Short-term investments consist of certificate of deposit accounts that expire within 12 months for which market prices are readily available. The restrictions placed on the certificate of deposit accounts have a negligible effect on the fair value of these financial assets; these funds are restricted to meet the Company’s obligation for workers’ compensation claims.
 
The Company adopted the required fair value measurements and disclosures provisions related to nonfinancial assets and liabilities. These assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include long-lived assets, goodwill, and intangible assets for which the fair value of assets is determined as part of the related impairment test. As of June 30, 2014 and December 31, 2013, there were no significant adjustments to fair value for nonfinancial assets or liabilities.

9. Goodwill and Intangible Assets

Intangible assets include product rights, trademarks, patents, land-use rights, and goodwill. The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification:

   
Weighted-Average
Life (Years)
   
Original Cost
   
Accumulated
Amortization
   
Net Book Value
 
         
(in thousands)
 
Definite-lived intangible assets
                       
Product rights
  12     $ 27,134     $ 20,005     $ 7,129  
Patents
  10       293       63       230  
Trademarks
  11       17       13       4  
Land-use rights
  39       2,540       189       2,351  
Other intangible assets
  1       505       505        
Subtotal
  12       30,489       20,775       9,714  
Indefinite-lived intangible assets
                             
Trademark
  *       29,225             29,225  
Goodwill
  *       280             280  
AFP customers
  *       111             111  
Subtotal
  *       29,616             29,616  
As of June 30, 2014
  *     $ 60,105     $ 20,775     $ 39,330  

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
   
Weighted-Average
Life (Years)
   
Original Cost
   
Accumulated
Amortization
   
Net Book Value
 
         
(in thousands)
 
Definite-lived intangible assets
                       
Product rights
  12     $ 27,134     $ 19,114     $ 8,020  
Patents
  10       298       50       248  
Trademarks
  11       19       13       6  
Land-use rights
  39       2,540       156       2,384  
Other intangible assets
  1       505       505        
Subtotal
  11       30,496       19,838       10,658  
Indefinite-lived intangible assets
                             
Trademark
  *       29,225             29,225  
Goodwill
  *       280             280  
Subtotal
  *       29,505             29,505  
As of December 31, 2013
  *     $ 60,001     $ 19,838     $ 40,163  
_______________________________
  *   Intangible assets with indefinite lives have an undeterminable average life.

Primatene Mist Trademark

In January, 2009, the Company acquired the exclusive rights to the trademark, domain name, website and domestic marketing, distribution and selling rights related to Primatene Mist, an over-the-counter bronchodilator product, for a total consideration of $29.2 million, which is its carrying value as of June 30, 2014.

In determining the useful life of the trademark, the Company considered the following: the expected use of the intangible; the longevity of the brand; the legal, regulatory and contractual provisions that affect their maximum useful life; the Company’s ability to renew or extend the asset’s legal or contractual life without substantial costs; effects of the regulatory environment; expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors.

As a result of environmental concerns about Chlorofluorocarbons, or CFCs, the FDA issued a final ruling on January 16, 2009 that required the CFC formulation of its Primatene Mist product to be phased out by December 31, 2011. The former formulation of Primatene Mist contained CFCs as a propellant; however, the Company intends to use the trademark for a future version of Primatene Mist that utilizes hydrofluoroalkane, or HFA, as a propellant.

In 2013, the Company filed a new drug application, or NDA, for Primatene Mist HFA and received a Prescription Drug User Fee Act date set for May 2014.

In May 2014, the Company received a complete response letter, or CRL, from the FDA, which requires additional non-clinical information, label revisions and follow-up studies (label comprehension, behavioral and actual use) to assess consumers’ ability to use the device correctly to support approval of the product in the over-the-counter setting. Additionally, in the CRL for Primatene Mist HFA, the FDA noted current Good Manufacturing Practices, or cGMP, deficiencies in a recent inspection of the Company’s API supplier’s manufacturing facility, which produces epinephrine, and indicated that the Company’s NDA could not be approved until these issues were resolved. Subsequent to the receipt of the CRL, the supplier notified the Company that the cGMP deficiencies were satisfactorily resolved. Accordingly, the Company believes this condition for approval has been satisfied. The Company is in the process of generating the remaining data required by the CRL and will submit an NDA Amendment that it believes will address the FDA’s concerns. However, there can be no guarantee that any amendment to the Company’s NDA will result in timely approval of the product or approval at all.

Based on the Company’s filed version of Primatene Mist HFA, the Company’s plan to submit an NDA amendment to address the FDA’s concerns, the long history of the Primatene Mist trademark (marketed since 1963) and the Company’s perpetual rights to the trademark, the Company has determined that the trademark has an indefinite useful life. If the HFA version is approved by the FDA, it will be marketed under the same trade name; therefore, an impairment charge would not be required.

10. Inventories

Inventories are stated at the lower of cost or market, using the first-in, first-out method. Provisions are made for slow-moving, unsellable or obsolete items. Inventories consist of currently marketed products and products manufactured under contract.  Inventories consist of the following:

   
June 30,
2014
   
December 31,
2013
 
   
(in thousands)
 
Raw materials and supplies
  $ 51,162     $ 34,470  
Work in process
    22,770       14,698  
Finished goods
    34,184       26,501  
Total inventory
    108,116       75,669  
Less reserve for excess and obsolete inventories
    (2,099 )     (5,753 )
Total inventory, net
  $ 106,017     $ 69,916  
 
 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
11.  Property, Plant, and Equipment

Property, plant, and equipment consist of the following:

   
June 30,
2014
   
December 31,
2013
 
   
(in thousands)
 
Building
  $ 64,156     $ 58,898  
Leasehold improvements
    23,935       23,834  
Land
    7,174       5,805  
Machinery and equipment
    104,140       93,617  
Furniture, fixtures, and automobiles
    10,947       9,355  
Construction in progress
    19,800       15,685  
Total property, plant, and equipment
    230,152       207,194  
Less accumulated depreciation and amortization
    (96,161 )     (90,575 )
Total property, plant, and equipment, net
  $ 133,991     $ 116,619  

As of June 30, 2014 and December 31, 2013, the Company had $3.2 million and $3.4 million in capitalized manufacturing equipment that is intended to be used specifically for the manufacture of Primatene Mist HFA, respectively. The Company will continue to monitor developments with the FDA as it relates to its Primatene Mist HFA indefinite lived intangible asset in determining if there is an impairment for these related fixed assets (see Note 9).

12. Impairment of Long-Lived Assets

All of the Company’s impairments relate primarily to the write-off of certain manufacturing equipment related to abandoned projects. For the three months and six months ended June 30, 2014, the Company recorded an impairment loss of $0.2 million and $0.3 million, respectively. For the three and six months ended June 30, 2013, the Company did not record an impairment loss.

13. Debt

Debt consists of the following:

   
June 30,
2014
   
December 31,
2013
 
   
(in thousands)
 
Loans with East West Bank
           
             
Mortgage payable due January 2016
  $ 3,965     $ 4,041  
Mortgage payable due September 2016
    2,327       2,364  
Equipment loan due November 2014
    360       783  
Line of credit facility due March 2016
           
Equipment loan due April 2017
    3,518       4,103  
Line of credit facility due January 2019
           
                 
Loans with Cathay Bank
               
                 
Mortgage payable due April 2021
    4,591       4,624  
Revolving line of credit due May 2016
          15,000  
Acquisition loan due April 2019
    21,770        
                 
Payment obligation to Merck Sharpe & Dohme
    15,869        
                 
Equipment Under Capital Leases
    1,115       1,258  
Total debt and capital leases
    53,515       32,173  
Less current portion of long-term debt and capital leases
    10,665       22,104  
Long-term debt, net of current portion and capital leases
  $ 42,850     $ 10,069  

Loans with East West Bank

Mortgage Payable—Due January 2016

In December 2010, the Company refinanced an existing mortgage term loan, which had a principal balance outstanding of $4.5 million at December 31, 2010. The loan is payable in monthly installments with a final balloon payment of $3.8 million. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex, as well as one of its buildings at its Chino, California, complex. The loan bears a variable interest rate at the prime rate as published by The Wall Street Journal, with a minimum interest rate of 5.00%, and matures in January 2016.

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
Mortgage Payable—Due September 2016

In September 2006, the Company entered into a mortgage term loan in the principal amount of $2.8 million, which matures in September 2016. The loan is payable in monthly installments with a final balloon payment of $2.2 million plus interest. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The variable interest rate is equal to the three-month LIBOR plus 2.50%.

Equipment Loan—Due November 2014

In May 2009, the Company entered into an $8.0 million revolving credit facility that converted the outstanding principal balance of $3.2 million in November 2010 into an equipment loan. Borrowings under the facility are secured by equipment purchased with debt proceeds. The facility bears interest at the prime rate as published by The Wall Street Journal, with a minimum interest rate of 5.00%, and matures in November 2014.

Line of Credit Facility—Due March 2016

In March 2012, the Company entered into a $10.0 million line of credit   facility. Borrowings under the facility are secured by inventory and accounts receivable.  Borrowings under the facility bear interest at the prime rate as published by The Wall Street Journal . This facility was to mature in July 2014.  In April 2014, the Company extended the maturity date to March 2016.  As of June 30, 2014, the Company did not have any amounts outstanding under this facility.

Equipment Loan—Due April 2017

In March 2012, the Company entered into an $8.0 million revolving credit facility that converted the outstanding principal balance of $4.9 million in March 2013 into an equipment loan. Borrowings under the facility are secured by equipment purchased with debt proceeds. Borrowings under the facility bear interest at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 3.50%. This facility matures in April 2017.

Line of Credit Facility—Due January 2019

In July 2013, the Company entered into an $8.0 million line of credit facility.  Borrowings under the facility are secured by equipment. The facility bears interest at the prime rate as published in The Wall Street Journal plus 0.25% and matures in January 2019.  As of June 30, 2014, the Company did not have any amounts outstanding under this facility.

Loans with Cathay Bank

Mortgage Payable—Due April 2021
 
In March 2007, the Company entered into a mortgage term loan in the principal amount of $5.3 million, which matured in March 2014.  In April 2014, the Company refinanced the mortgage term loan, which had a principle balance outstanding of $4.6 million.  The loan is payable in monthly installments of $28.1 thousand with a final balloon payment of $3.9 million.  The loan is secured by the building at the Company’s Canton, Massachusetts, location and bears interest at a fixed rate of 5.42% and matures in April 2021.  As of June 30, 2014, the loan had a fair value of $4.9 million, compared to a book value of $4.6 million. The fair value of the loan was determined by using the interest rate associated with the Company’s mortgage loans with similar terms and collateral that has variable interest rates. The fair value of debt obligations is not measured on a recurring basis and the variable interest rate is deemed to be a Level 2 input for measuring fair value.

Revolving Line of Credit—Due May 2016

In April 2012, the Company entered into a $20.0 million revolving line of credit facility.  Borrowings under the facility are secured by inventory, accounts receivables, and intangibles held by the Company.  The facility bears interest at the prime rate as published by The Wall Street Journal with a minimum interest rate of 4.00%.  This revolving line of credit was to mature in May 2014.  In April 2014, the Company modified the facility to extend the maturity date to May 2016.   As of June 30, 2014, the Company did not have any amounts outstanding under this facility.

Acquisition Loan with Cathay Bank—Due April 2019 

On April 22, 2014, in conjunction with the Company’s acquisition of Merck’s API manufacturing business in Éragny-sur-Epte, France, the Company entered into a secured term loan with Cathay Bank as lender. The principal amount of the loan is $21.9 million and bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00%. Beginning on June 1, 2014 and through the maturity date, April 22, 2019, the Company must make monthly payments of principal and interest based on the then outstanding amount of the loan amortized over a 120-month period. On April 22, 2019, all amounts outstanding under the loan become due and payable, which would be approximately $12.0 million based upon an interest rate of 4.00%. The loan is secured by 65% of the issued and outstanding shares of stock in AFP and certain assets of the Company, including accounts receivable, inventory, certain investment property, goods, deposit accounts, and general intangibles but not including the Company’s equipment and real property.

The loan includes customary restrictions on, among other things, the Company’s ability to incur additional indebtedness, pay dividends in cash or make other distributions in cash, make certain investments, create liens, sell assets, and make loans. The loan also includes customary events of defaults, the occurrence and continuation of any of which provide Cathay Bank the right to exercise remedies against the Company and the collateral securing the loan. These events of default include, among other things, the Company’s failure to pay any amounts due under the loan, the Company’s insolvency, the occurrence of any default under certain other indebtedness or material agreements, and a final judgment against the Company that is not discharged in 30 days.

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
Payment obligation

Merck Sharpe & Dohme—Due December 2017
 
On April 30, 2014, in conjunction with the Company’s acquisition of Merck’s API manufacturing business in Éragny-sur-Epte, France, the Company entered into a commitment obligation with Merck, in the principal amount of €11.6 million, or $16.0 million, subject to currency exchange fluctuations.  The terms of the purchase price include annual payments over four years and bear a fixed interest rate of 3.00%. The final payment to Merck relating to this obligation is due December 2017.

As of June 30, 2014, the payment obligation had a book value of $15.9 million, which approximates fair value.  The fair value of the payment obligation was determined by using the interest rate associated with the Company’s acquisition loan with Cathay Bank that bears a variable interest rate at the prime rate as published by the Wall Street Journal , with a minimum interest rate of 4.00%.  The fair value of the debt obligation is not measured on a recurring basis and the variable interest rate is deemed to be a Level 2 input for measuring fair value.
 
Covenants

At June 30, 2014 and December 31, 2013, the Company was in compliance with its debt covenants, which include a minimum current ratio, minimum debt service coverage, minimum tangible net worth, and maximum debt-to-effective-tangible-net-worth ratio, computed on a consolidated basis in some instances and on a separate-company basis in others.

Equipment under Capital Leases

The Company entered into leases for certain equipment under capital leasing arrangements, which will expire at various times through 2018. The cost of equipment under capital leases was $1.5 million and $1.5 million at June 30, 2014 and December 31, 2013, respectively.

The accumulated amortization of equipment under capital leases was $0.3 million and $0.2 million at June 30, 2014 and December 31, 2013, respectively. Amortization of assets recorded under capital leases is included in depreciation and amortization expense in the accompanying consolidated financial statements.

14. Income Taxes

The following table sets forth the Company’s income tax provision for the periods indicated:
 
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2014
   
2013
   
2014
   
2013
 
   
(in thousands)
 
                         
Income (loss) before taxes
  $ (1,876 )   $ 11,919     $ (4,347 )   $ 14,111  
Income tax provision (benefit)
    (696 )     4,109       (1,548 )     3,919  
Net income (loss)
  $ (1,180 )   $ 7,810     $ (2,799 )   $ 10,192  
Income tax provision (benefit) as a percentage of income before income taxes
    (37.1 %)     34.5 %     (35.6 %)     27.8 %
 
The Company’s income tax benefit for the three and six months ended June 30, 2014 was (37.1%) and (35.6%) of income before income taxes, respectively.  The blended effective income tax rate expected for the year ended December 31, 2014 is 36.2%.  This tax provision rate factors in various domestic deductions and the impact of foreign operations on the Company’s overall tax rate. The Company’s income tax provision rate of 34.5% and 27.8% during the three and six months ended June 30, 2013, respectively factored in similar deductions as well as the impact of foreign operations.

Undistributed Earnings (Losses) from Foreign Operations

Deferred income taxes have not been provided on the accumulated undistributed losses of the Company’s foreign subsidiaries of approximately $5.8 million and $5.0 million as of June 30, 2014 and December 31, 2013, respectively. The Company does not have plans to repatriate its foreign earnings to the U.S. as dividends.

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
15. Stockholders' Equity

A summary of the changes in stockholders’ equity for the six months ended June 30, 2014 consisted of the following:

   
Six Months Ended
June 30,
2014
 
   
(in thousands)
 
       
Stockholders’ equity as of December 31, 2013
  $ 251,545  
Net loss
    (2,799 )
Other comprehensive loss
    (268 )
Common stock issued through initial public offering
    38,018  
Cost related to public offering
    (3,347 )
Exercise of stock options
    571  
Nonemployee share-based compensation expense
    475  
Employee share-based compensation expense
    3,546  
Stockholders’ equity as of June 30, 2014
  $ 287,741  

Accumulated Other Comprehensive Loss

For the Company’s recently acquired subsidiary in France, the Euro, which is the local currency in France, has been determined to be the functional currency.  The results of the Company’s French subsidiary’s operations are translated to U.S. dollars at the average exchange rates during the period.  Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date.  Equity is translated at the prevailing rate of exchange at the date of the equity transaction.  Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive loss for the three and six months ended June 30, 2014.

Common Stock

In June 2014, the Company completed an Initial Public Offering in which the Company sold 5,840,000 shares of its common stock, which included 1,200,000 shares of the Company’s common stock pursuant to the underwriters’ exercise of their over-allotment option, at a price to the public of $7.00 per share, resulting in gross proceeds of $40.9 million.  In connection with the offering, the Company paid $6.2 million in underwriting discounts, commissions, and offering costs, resulting in net proceeds of $34.7 million.

Share-Based Award Activity and Balances

The Company accounts for share-based compensation payments in accordance with FASB-issued accounting standards, which require measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees, directors, and nonemployees. Under these standards, the fair value of share-based payment awards is estimated at the grant date using an option-pricing model and the portion that is ultimately expected to vest is recognized as compensation cost over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of share-based awards and recognizes share-based compensation cost over the vesting period using the straight-line single option method.  Non-vested stock options held by non-employees are revalued using the Company’s estimate of fair value at each balance sheet date.

The weighted-averages for key assumptions used in determining the fair value of options granted during the three and six months ended June 30, 2014 and 2013 are as follows:

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2014
   
2013
   
2014
   
2013
 
                                 
Average volatility
    33.3 %     31.7 %     29.9 %     31.7 %
Risk-free interest rate
    2.2 %     1.5 %     1.7 %     1.5 %
Weighted-average expected life in years
    6.3       6.3       5.0       6.3  
Dividend yield rate
    0.0 %     0.0 %     0.0 %     0.0 %

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
Stock Options

A summary of option activity under all plans for the six months ended June 30, 2014 is presented below:

   
Options
   
Weighted-
Average
Exercise
Price
   
Weighted-
Average
Remaining
Contractual
Term (Years)
   
Aggregate
Intrinsic
Value (1)
 
                     
(in thousands)
 
Outstanding as of December 31, 2013
    10,771,755     $ 15.39              
Options granted
    1,661,862       15.04              
Options exercised
    (30,000 )     19.03              
Options cancelled
    (42,600 )     12.01              
Options expired
    (51,788 )     20.00              
Outstanding as of June 30, 2014
    12,309,229     $ 15.32       4.82     $ 224  
Exercisable as of June 30, 2014
    5,244,799     $ 18.64       3.03     $ 224  
_________________________
(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 June 30, 2014.

For the three and six months ended June 30, 2014, the Company recorded stock option expense related to employees under all plans of $1.8 million and $3.1 million, respectively. For the three and six months ended June 30, 2013, the Company recorded stock option expense related to employees under all plans of $1.0 million and $2.3 million, respectively.

Information relating to option grants and exercises is as follows:
 
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2014
   
2013
   
2014
   
2013
 
   
(in thousands, except per share data)
 
Weighted-average grant date fair value
  $ 5.33     $ 3.66     $ 4.02     $ 3.66  
Intrinsic value of options exercised
    (139 )     (4 )     (139 )     (4 )
Cash received
    571       13       571       13  
Total fair value of the options vested during the year
    290       301       816       855  
 
A summary of the status of the Company’s nonvested options as of June 30, 2014, and changes during the six months ended June 30, 2014, are presented below:

   
Options
   
Weighted-Average
Grant Date
Fair Value
 
Nonvested as of December 31, 2013
    5,617,554     $ 3.12  
Options granted
    1,661,862       4.02  
Options vested
    (172,386 )     4.73  
Options forfeited
    (42,600 )     4.31  
Nonvested as of June 30, 2014
    7,064,430       3.29  

As of June 30, 2014, there was $15.6 million of total unrecognized compensation cost, net of forfeitures, related to nonvested stock option based compensation arrangements granted under the Company’s 2005 Equity Incentive Award Plan, or the 2005 Plan. The cost is expected to be recognized over a weighted-average period of 2.6 years and will be adjusted for future changes in estimated forfeitures.

Deferred Stock Units

From 2007 through 2014, the Company granted restricted stock awards in the form of deferred stock units, or DSUs, to certain officers, consultants, and employees, either as compensation or in exchange for expiring stock options. The grantee receives one share of common stock at a specified future date for each DSU awarded. The DSUs may not be sold or otherwise transferred until certificates of common stock have been issued, recorded, and delivered to the participant. The DSUs do not have any voting or dividend rights prior to the issuance of certificates of the underlying common stock.

The Company issued DSUs that were treated as an accounting exchange for expiring stock options, whereby the fair value of the expiring stock options equaled the fair value of the DSUs at the date of the exchange. As such, the Company did not record any expense related to these award modifications.

Additionally, the Company issued DSUs to its Board of Directors and employees as compensation with a vesting period of up to five years.  The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period.  The Company recorded a total expense of $0.5 million and $0.7 million for the three and six months ended June 30, 2014, respectively, for these DSU awards, compared to the prior year expense for the three and six months ended June 30, 2013 of $0.1 million and $0.3 million, respectively.
 
 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
As of June 30, 2014, there was $6.0 million of total unrecognized compensation cost, net of forfeitures, related to nonvested DSU-based compensation arrangements granted under the 2005 Plan. The cost is expected to be recognized over a weighted-average period of 3.5 years and will be adjusted for future changes in estimated forfeitures.

Information relating to DSU grants and deliveries is as follows:

   
Total DSUs Issued
   
Total Fair Market
Value of DSUs Issued
as Compensation (1)
 
         
(in thousands)
 
DSUs outstanding at December 31, 2013
    98,495        
DSUs granted
    414,868     $ 5,974  
DSUs outstanding at June 30, 2014
    513,363          
____________________________
(1)
The total FMV is derived from the number of DSUs granted times the current stock price on the date of grant.

16. Commitments and Contingencies

Distribution Agreement with Actavis, Inc.

In May 2005, the Company entered into an agreement to grant certain exclusive marketing rights for its enoxaparin product to Andrx Pharmaceuticals, Inc., or Andrx, which generally extends to the U.S. retail pharmacy market. To obtain such rights, Andrx made a non-refundable, upfront payment of $4.5 million to the Company upon execution of the agreement.  Under the agreement, the Company is paid a fixed cost per unit sold to Andrx and also shares in the gross profits (as defined) from Andrx’s sales of the product in the U.S. retail pharmacy market. In November 2006, Watson Pharmaceuticals, Inc., or Watson, acquired Andrx and all of the rights and obligations associated with the agreement. The $4.5 million upfront payment was classified as deferred revenue on the accompanying consolidated balance sheets, as there had been no amortization through December 31, 2011.

In January 2012, the Federal Circuit Court issued a stay on the Preliminary Injunction (see Note 17) that had previously barred the Company from selling its generic enoxaparin product. This event, in addition to the Company’s product launch, establishes the beginning of the seven-year period in which Watson has the exclusive marketing rights for the Company’s enoxaparin product in the U.S. retail pharmacy market and the start of the Company’s recognition of the $4.5 million deferred revenue over this period on a straight-line basis. Watson has an option to renew the agreement for an additional three years.  As of June 30, 2014 and December 31, 2013, the balance of the deferred revenue was $2.9 million and $3.3 million, respectively.
 
In January 2013, Watson adopted Actavis, Inc. as its new global name. The agreement has a term that expires in January 2019 and can be extended by Actavis for an additional three years. The agreement may only be terminated prior to the end of the term by either party in the case of a breach of contract or insolvency of the other party, by the Company if Actavis fails to purchase a minimum number of units and by Actavis if an infringement claim is made against Actavis.

The Company manufactures its enoxaparin product for the retail market according to demand specifications of Actavis. Upon shipment of enoxaparin to Actavis, the Company recognizes product sales at an agreed transfer price and records the related cost of products sold. Based on the terms of the Company’s distribution agreement with Actavis, the Company is entitled to a share of the ultimate profits based on the eventual net revenue from enoxaparin sales by Actavis to the end user less the agreed transfer price originally paid by Actavis to the Company. Actavis provides the Company with a quarterly sales report that calculates the Company’s share of Actavis’ enoxaparin gross profit. The Company records its share of Actavis’ gross profit as a component of net revenue.

Operating Lease Agreements

The Company leases real and personal property, in the normal course of business, under various non-cancelable operating leases. The Company, at its option, can renew a substantial portion of its leases, at the market rate, for various renewal periods ranging from one to six years. Rental expense under these leases for the three and six months ended June 30, 2014 was approximately $1.4 million and $2.2 million, respectively, compared to the prior year three and six months ended June 30, 2013 when the expense was approximately $0.8 million and $1.6 million, respectively.

Purchase Commitments

As of June 30, 2014, the Company has entered into commitments to purchase equipment and raw materials for an aggregate of $8.7 million. The Company anticipates that most of these commitments will be fulfilled by 2015.

The Company has entered into agreements with a Chinese governmental entity to acquire land-use rights to real property in Nanjing, China. Under the terms of these agreements, the Company has committed to invest capital in its wholly-owned subsidiary, ANP, and to develop these properties as an API manufacturing facility for the Company’s pipeline. In conjunction with these agreements, ANP modified its business license on July 3, 2012 to increase its authorized capital. As of June 30, 2014, the Company had invested approximately $37.8 million in ANP of its registered capital commitment of $61.0 million. The Company has committed to invest an additional $23.2 million in ANP, which is currently due by December 2014. This requirement to invest in ANP will result in cash being transferred from the U.S. parent company to ANP.

 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
Per these agreements, in January 2010, the Company acquired certain land-use rights with a carrying value of $1.2 million.  In addition, the Company purchased additional land-use rights in November 2012 for $1.3 million.  The Company is committed to spend approximately $15.0 million in land development.  The agreements require the construction of fixed assets on the property and specified a timetable for the construction of these fixed assets. The current pace of development of the property is behind the schedules described in the purchase agreements and, per the purchase agreement, potential monetary penalties could result if the development is delayed or not completed in accordance with the guidelines stated in the purchase agreements. The Company is currently engaged in ongoing discussions with the Chinese governmental entity regarding the investment and the development of the properties. The Company believes that the Chinese governmental entity will accept its development plans for ANP.

Government Regulation

The Company’s products and facilities are subject to regulation by a number of federal and state governmental agencies. The Food and Drug Administration, or FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of the Company’s products.  The Drug Enforcement Administration, or DEA, maintains oversight over the Company’s products that are considered controlled substances.

On March 31, 2014 through April 4, 2014, the Company’s facility in Nanjing, China was subject to an inspection by the FDA. The inspection resulted in multiple observations on Form 483, an FDA form on which deficiencies are noted after an FDA inspection. The Company responded to those observations on April 25, 2014 and is in the process of implementing the required corrective actions.

On March 31, 2014 through April 3, 2014, the Company’s facility in Canton, MA was subject to a preapproval inspection by the FDA relating to the Company’s NDA for Primatene. The inspection did not result in any observations on Form 483.

From July 9, 2014 through August 8, 2014, the Company was subject to an inspection by the FDA. The inspection included a review of current Good Manufacturing Practices, preapproval inspections for two ANDAs currently being reviewed by the FDA, and a review of post-market adverse drug events. The inspections resulted in multiple observations on Form 483. The Company plans to respond to those observations by August 25, 2014.
 
AFP Environmental Indemnification

Prior to the Company’s purchase of Merck’s facility in Éragny-sur-Epte, France, Merck notified the Company of several items it had identified as part of its own internal auditing that relate to potential minor environmental issues.  The Company understands from Merck that it identified these items because the items were not in alignment with Merck’s own internal policies and procedures, and not because any of the items are in violation of any French environmental law or regulation.  Under a letter of understanding, or LOU, dated April 30, 2014, Merck has agreed to pay for the remediation costs up to certain dollar limits, and to date, all estimates suggest the cost of conducting the remediation will be less than those dollar limits.  The LOU also includes an indemnification provision that would require the Company to indemnify Merck for liability that might arise from performance of the remediation work itself but not for other types of liability.

17. Litigation

Enoxaparin Patent Litigation

In September 2011, Momenta Pharmaceuticals, Inc, or Momenta, a Boston-based pharmaceutical company, and Sandoz Inc, or Sandoz, the generic division of Novartis, initiated litigation against the Company for alleged patent infringement of two patents related to testing methods for batch release of enoxaparin, which the Company refers to as the “‘886 patent” and the “‘466 patent.” The lawsuit was filed in the United States District Court for the District of Massachusetts, or the District Court. In October 2011, the District Court issued a preliminary injunction barring the Company from selling its generic enoxaparin product and also requiring Momenta and Sandoz to post a $100.1 million bond. The preliminary injunction was stayed by the United States Court of Appeals for the Federal Circuit, or Federal Circuit, in January 2012 and reversed by the Federal Circuit in August 2012.

In January 2013, the Company moved for summary judgment of non-infringement of both patents. Momenta and Sandoz withdrew their allegations as to the ‘466 patent, and in July 2013, the District Court granted the Company’s motion for summary judgment of non-infringement of the ‘886 patent and denied Momenta and Sandoz’s motion for leave to amend infringement contentions. On January 24, 2014, the District Court judge entered final judgment in Amphastar’s favor on both patents. Momenta and Sandoz also filed a motion to collect attorney’s fees and costs relating to a discovery motion which the District Court granted. The parties have briefed the amount of attorney’s fees that should be imposed, which the Company believes should not exceed an amount of approximately $40.0 thousand. On January 30, 2014, Momenta and Sandoz filed a notice of appeal to the Federal Circuit appealing the court’s final judgment including summary judgment denying Momenta and Sandoz’s motion for leave to amend their infringement contentions. The Company intends to attempt to collect the $100.1 million bond posted by Momenta and Sandoz following the appeal   Momenta filed its opening appeal brief on June 27, 2014. Under the current briefing schedule for the appeal, the Company’s brief is due by September 25, 2014, and Momenta’s reply brief is due by October 13, 2014. A date for oral argument has not yet been set by the court of appeal.

False Claims Act Litigation
 
In January 2009, the Company filed a qui tam complaint in the U.S. District Court for the Central District of California alleging that Aventis Pharma S.A., or Aventis, through its acquisition of a patent through false and misleading statements to the U.S. Patent and Trademark Office, as well as through false and misleading statements to the FDA, overcharged the federal and state governments for its Lovenox product. If the Company is successful in this litigation, it could be entitled to a portion of any damage award that the government ultimately may recover from Aventis. In October 2011, the District Court unsealed the Company’s complaint. Since the complaint was unsealed, this case has steadily progressed and remains pending with discovery underway. On February 28, 2014, Aventis filed a motion for summary judgment on the issue of the adequacy of the Company’s notice letter to the government, and the District Court denied Aventis’ motion for summary judgment in a final order it issued on May 12, 2014. On June 9, 2014, at Aventis’ request, the District Court issued an order certifying for appeal its order denying Aventis’ motion for summary judgment. On June 9, 2014, Aventis filed with the United States Court of Appeals for the Ninth Circuit a petition for permission to appeal the District Court’s denial of Aventis’ motion for summary judgment, and the Company filed an opposition to Aventis’ petition on June 19, 2014. The District Court set an evidentiary hearing for July 7, 2014 on the “original source” issue, a key element under the False Claims Act.  The evidentiary hearing was conducted as scheduled, from July 7, 2014 through July 10, 2014, and the parties are expected to file post-hearing briefs. The Company filed its post-hearing brief on August 11, 2014, and Aventis’ post-hearing brief is due by September 10, 2014. The District Court set a hearing for closing argument on the original source issue for October 10, 2014.
 
 
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
Other Litigation

The Company is also subject to various other claims and lawsuits arising in the ordinary course of business. In the opinion of management, the ultimate resolution of these matters is not expected to have a materially adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.

18. Subsequent Event

Supply Agreement with MannKind Corporation

Subsequent to the quarter end, on July 31, 2014, the Company’s French subsidiary, Amphastar France Pharmaceuticals SAS, or AFP, entered in a supply agreement with MannKind Corporation, or MannKind, pursuant to which AFP will manufacture for and supply to MannKind certain quantities of recombinant human insulin, or Insulin, for use in MannKind’s product AFREZZA ® . Under the terms of the supply agreement, AFP will be responsible for manufacturing the Insulin in accordance with MannKind’s specifications and agreed-upon quality standards.  MannKind has agreed to purchase annual minimum quantities of Insulin under the supply agreement of an aggregate of approximately €120.1 million, or approximately $160.7 million, in calendar years 2015 through 2019.  MannKind may request to purchase additional quantities of Insulin over such annual minimum quantities.

Within five business days of executing of the agreement, MannKind made a non-refundable reservation fee to AFP in the amount of €11.0 million, or approximately $14.7 million.  Under the agreement, the non-refundable reservation fee is considered as partial payment for the purchase commitment quantity for 2015. The Company classified the amount as deferred revenue.

 Unless earlier terminated, the term of the supply agreement expires on December 31, 2019 and can be renewed for additional, successive two-year terms upon 12 months’ written notice given prior to the end of the initial term or any additional two-year term.  MannKind and AFP each have normal and customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy, or insolvency of the other party. In addition, MannKind may terminate the supply agreement upon two years’ prior written notice to AFP without cause or upon 30 days prior written notice to AFP if a controlling regulatory authority withdraws approval for AFREZZA ® ; provided, however, in the event of a termination pursuant to either of these scenarios, the provisions of the supply agreement require MannKind to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. 
 
 
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward looking statements

The following discussion of our financial condition and the results of operations should be read in conjunction with the “Condensed Consolidated Financial Statements” and notes thereto included elsewhere in this Quarterly Report on Form 10-Q, or Quarterly Report. This discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties, and other factors include, among others, those identified under the “Note Regarding Forward-Looking Statements,” above, and elsewhere in this Quarterly Report, particularly in Part II. Item 1A. “Risk Factors,” below.
 
Overview of Amphastar

Amphastar Pharmaceuticals, Inc., together with its wholly-owned subsidiaries, International Medication Systems, Limited, or IMS; Amphastar Laboratories, Inc.; Armstrong Pharmaceuticals, Inc., or Armstrong; Amphastar Nanjing Pharmaceuticals Co., Ltd., or ANP; and Amphastar France Pharmaceuticals, SAS, or AFP, (collectively, “Amphastar,” “ the Company,” or “we”), is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation products, including a portfolio of generic and proprietary products with high technical barriers to market entry.  Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.  The Company’s inhalation products will be primarily distributed through drug retailers when they are brought to the market.

2014 Significant Business Developments

During 2014, the Company announced the following transactions that impacted its results of operations and will continue to have an impact on its future operations.

Acquisition of Merck Sharpe & Dohme’s API Manufacturing Business

On April 30, 2014, the Company completed its acquisition of Merck Sharpe & Dohme’s, or Merck’s, active pharmaceutical ingredient, or API, manufacturing business in Éragny-sur-Epte, France, which manufactures porcine insulin API and recombinant human insulin API. The purchase price of the transaction on April 30, 2014 totaled €24.8 million, or $34.4 million, subject to certain customary post-closing adjustments and currency exchange fluctuations. The terms of the purchase include multiple payments over four years as follows:
 
   
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