☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
March 31, 2018
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to _______________
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Impax Laboratories, LLC
|
||
(Exact name of registrant as specified in its charter)
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||
Delaware
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65-0403311
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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30831 Huntwood Avenue, Hayward, CA
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94544
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(Address of principal executive offices)
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(Zip Code)
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(510) 240-6000
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(Registrant’s telephone number, including area code)
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Impax Laboratories, Inc.
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||
(Former name, former address and former fiscal year, if changed since last report)
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer (Do not check if a smaller reporting company)
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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PART I - FINANCIAL INFORMATION
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||
Item 1.
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Financial Statements.
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|
- Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017
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||
- Consolidated Statements of Operations for the three months ended March 31, 2018 and 2017
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||
- Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2018 and 2017
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||
- Consolidated Statements of Cash Flows for the three months ended March 31, 2018 and 2017
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||
- Notes to Interim Consolidated Financial Statements
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||
Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk.
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Item 4.
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Controls and Procedures.
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PART II - OTHER INFORMATION
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||
Item 1.
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Legal Proceedings.
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Item 1A.
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Risk Factors.
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds.
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Item 3.
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Defaults Upon Senior Securities.
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Item 4.
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Mine Safety Disclosures.
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Item 5.
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Other Information.
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Item 6.
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Exhibits.
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SIGNATURES
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March 31, 2018
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|
December 31, 2017
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||||
Assets
|
|
|
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||||
Current assets:
|
|
|
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||||
Cash and cash equivalents
|
$
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104,192
|
|
|
$
|
181,778
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Accounts receivable, net
|
226,373
|
|
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240,753
|
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||
Inventory, net
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158,591
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|
|
158,471
|
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||
Prepaid expenses and other current assets
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20,211
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|
|
21,086
|
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||
Income tax receivable
|
68,294
|
|
|
61,201
|
|
||
Assets held for sale
|
—
|
|
|
32,266
|
|
||
Total current assets
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577,661
|
|
|
695,555
|
|
||
Property, plant and equipment, net
|
123,288
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|
|
124,813
|
|
||
Intangible assets, net
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248,994
|
|
|
262,467
|
|
||
Goodwill
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207,329
|
|
|
207,329
|
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||
Other non-current assets
|
63,626
|
|
|
61,136
|
|
||
Total assets
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$
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1,220,898
|
|
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$
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1,351,300
|
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Liabilities and Stockholders' Equity
|
|
|
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||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
65,261
|
|
|
$
|
81,093
|
|
Accrued expenses
|
268,676
|
|
|
248,127
|
|
||
Liabilities held for sale
|
—
|
|
|
7,170
|
|
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Current portion of long-term debt, net
|
17,859
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|
|
17,848
|
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Total current liabilities
|
351,796
|
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|
354,238
|
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Long-term debt, net
|
771,216
|
|
|
769,524
|
|
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Deferred income taxes
|
660
|
|
|
3,226
|
|
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Other non-current liabilities
|
37,623
|
|
|
37,111
|
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||
Total liabilities
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1,161,295
|
|
|
1,164,099
|
|
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Commitments and contingencies (Notes 17 & 18)
|
|
|
|
|
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||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.01 par value, 2,000,000 shares authorized; No shares issued or outstanding at March 31, 2018 and December 31, 2017
|
—
|
|
|
—
|
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Common stock, $0.01 par value, 150,000,000 shares authorized;
74,080,636 issued and 73,836,907 outstanding shares at March 31, 2018; 74,234,076 issued and 73,990,347 outstanding shares at December 31, 2017 |
741
|
|
|
742
|
|
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Treasury stock at cost: 243,729 shares at March 31, 2018 and December 31, 2017
|
(2,157
|
)
|
|
(2,157
|
)
|
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Additional paid-in capital
|
563,974
|
|
|
559,632
|
|
||
Accumulated deficit
|
(503,004
|
)
|
|
(372,445
|
)
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Accumulated other comprehensive income
|
49
|
|
|
1,429
|
|
||
Total stockholders’ equity
|
59,603
|
|
|
187,201
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,220,898
|
|
|
$
|
1,351,300
|
|
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Three Months Ended March 31,
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||||||
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2018
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|
2017
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||||
Revenues:
|
|
|
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||||
Impax Generics, net
|
$
|
83,141
|
|
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$
|
134,147
|
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Impax Specialty Pharma, net
|
59,214
|
|
|
50,256
|
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Total revenues
|
142,355
|
|
|
184,403
|
|
||
Cost of revenues
|
112,075
|
|
|
120,232
|
|
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Cost of revenues impairment charges
|
—
|
|
|
39,280
|
|
||
Gross profit
|
30,280
|
|
|
24,891
|
|
||
Operating expenses:
|
|
|
|
||||
Selling, general and administrative
|
57,323
|
|
|
47,055
|
|
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Research and development
|
12,296
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|
|
22,489
|
|
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In-process research and development impairment charges
|
—
|
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6,079
|
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Litigation, settlements and related charges
|
85,537
|
|
|
1,072
|
|
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Total operating expenses
|
155,156
|
|
|
76,695
|
|
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Loss from operations
|
(124,876
|
)
|
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(51,804
|
)
|
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Other income (expense):
|
|
|
|
||||
Interest expense, net
|
(13,692
|
)
|
|
(13,226
|
)
|
||
Loss on sale of assets
|
(385
|
)
|
|
—
|
|
||
Loss on debt extinguishment
|
—
|
|
|
(1,215
|
)
|
||
Other, net
|
731
|
|
|
(1,285
|
)
|
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Loss before income taxes
|
(138,222
|
)
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(67,530
|
)
|
||
(Benefit from) provision for income taxes
|
(7,290
|
)
|
|
30,901
|
|
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Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
|
|
|
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||||
Net loss per common share:
|
|
|
|
||||
Basic
|
$
|
(1.81
|
)
|
|
$
|
(1.37
|
)
|
Diluted
|
$
|
(1.81
|
)
|
|
$
|
(1.37
|
)
|
Weighted-average common shares outstanding:
|
|
|
|
||||
Basic
|
72,265,794
|
|
|
71,594,472
|
|
||
Diluted
|
72,265,794
|
|
|
71,594,472
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
Other comprehensive loss, net of tax:
|
|
|
|
||||
Change in foreign currency translation adjustments
|
(531
|
)
|
|
8,655
|
|
||
Foreign currency translation adjustments reclassified to other non-operating income
|
(849
|
)
|
|
—
|
|
||
Other comprehensive (loss) income
|
(1,380
|
)
|
|
8,655
|
|
||
Comprehensive loss
|
$
|
(132,312
|
)
|
|
$
|
(89,776
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
17,977
|
|
|
25,751
|
|
||
Non-cash interest expense
|
6,763
|
|
|
6,312
|
|
||
Share-based compensation expense
|
4,816
|
|
|
6,957
|
|
||
Deferred income taxes, net and uncertain tax positions
|
(2,591
|
)
|
|
32,195
|
|
||
Intangible asset impairment charges
|
—
|
|
|
45,359
|
|
||
Loss on sale of assets
|
385
|
|
|
—
|
|
||
Loss on debt extinguishment
|
—
|
|
|
1,215
|
|
||
Other
|
53
|
|
|
(245
|
)
|
||
Changes in certain assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
14,754
|
|
|
43,033
|
|
||
Inventory
|
2,460
|
|
|
(19,153
|
)
|
||
Prepaid expenses and other assets
|
(8,513
|
)
|
|
(6,525
|
)
|
||
Accounts payable and accrued expenses
|
8,811
|
|
|
806
|
|
||
Other liabilities
|
537
|
|
|
2,531
|
|
||
Net cash (used in) provided by operating activities
|
(85,480
|
)
|
|
39,805
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of property, plant and equipment
|
(3,958
|
)
|
|
(8,679
|
)
|
||
Proceeds from cash surrender value of life insurance policy
|
—
|
|
|
529
|
|
||
Proceeds from sale of assets
|
17,755
|
|
|
—
|
|
||
Net cash provided by (used in) investing activities
|
13,797
|
|
|
(8,150
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Repayment of term loan
|
(5,000
|
)
|
|
(55,000
|
)
|
||
Payment of deferred financing fees
|
—
|
|
|
(818
|
)
|
||
Payment of withholding taxes related to restricted stock awards
|
(982
|
)
|
|
(448
|
)
|
||
Proceeds from exercises of stock options and ESPP
|
505
|
|
|
170
|
|
||
Net cash used in financing activities
|
(5,477
|
)
|
|
(56,096
|
)
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(426
|
)
|
|
1,560
|
|
||
Net decrease in cash and cash equivalents
|
(77,586
|
)
|
|
(22,881
|
)
|
||
Cash and cash equivalents, beginning of period
|
181,778
|
|
|
180,133
|
|
||
Cash and cash equivalents, end of period
|
$
|
104,192
|
|
|
$
|
157,252
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
4,393
|
|
|
$
|
3,871
|
|
Cash paid for income taxes
|
2,329
|
|
|
3,500
|
|
•
|
Chargebacks - The Company has agreements establishing contract prices for certain products with certain indirect customers, such as retail pharmacy chains, group purchasing organizations, managed care organizations, hospitals and government agencies who purchase products from drug wholesalers. The contract prices are lower than the prices the customer would otherwise pay to the wholesaler, and the price difference is referred to as a chargeback, which generally takes the form of a credit memo issued by the Company to reduce the invoiced gross selling price charged to the wholesaler. An estimated accrued provision for chargeback deductions is recognized at the time of product shipment. The primary factors considered when estimating the provision for chargebacks are the average historical chargeback credits given, the mix of products shipped, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business. The Company also monitors actual chargebacks granted and compares them to the estimated provision for chargebacks to assess the reasonableness of the chargeback reserve at each quarterly balance sheet date.
|
•
|
Rebates and Administrative Fees - The Company maintains various rebate and administrative fee programs with its customers in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The rebates generally take the form of a credit memo to reduce the invoiced gross selling price charged to a customer for products shipped. An estimated accrued provision for rebate deductions is recognized at the time of product shipment. The primary factors the Company considers when estimating the provision for rebates are the average historical experience of aggregate credits issued, the mix of products shipped and the historical relationship of rebates as a percentage of total gross product sales, the contract terms and conditions of the various rebate programs in effect at the time of shipment, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business. The Company also monitors actual rebates granted and compares them to the estimated provision for rebates to assess the reasonableness of the rebate reserve at each quarterly balance sheet date.
|
•
|
Distribution Service Fees - The Company pays distribution service fees to several of its wholesaler customers related to sales of its Impax Products. The wholesalers are generally obligated to provide the Company with periodic outbound sales information as well as inventory levels of the Company’s Impax Products held in their warehouses. Additionally, the wholesalers have agreed to manage the variability of their purchases and inventory levels within specified days on hand limits. An accrued provision for distribution service fees is recognized at the time products are shipped to wholesalers.
|
•
|
Returns - The Company allows its customers to return for credit expired product under the terms of its published Returns Goods Policy. The Company estimates and recognizes an accrued provision for product returns as a percentage of gross sales based upon historical experience. The product return reserve is estimated using a historical lag period, which is the time between when the product is sold and when it is ultimately returned, and estimated return rates which may be adjusted based on various assumptions including: changes to internal policies and procedures, business practices, commercial terms with customers, and the competitive position of each product; the amount of inventory in the wholesale and retail supply chain; the introduction of new products; and changes in market sales information. The Company also considers other factors, including significant market changes which may impact future expected returns and actual product returns. The Company monitors actual returns on a quarterly basis and may record specific provisions for returns it believes are not covered by historical percentages.
|
•
|
Shelf-Stock Adjustments - Based upon competitive market conditions, the Company may reduce the selling price of certain Impax Generics division products. The Company may issue a credit against the sales amount to a customer based upon their remaining inventory of the product in question, provided the customer agrees to continue to make future purchases of product from the Company. This type of customer credit is referred to as a shelf-stock adjustment, which is the difference between the initial sales price and the revised lower sales price, multiplied by an estimate of the number of product units on hand at a given date. Decreases in selling prices are discretionary decisions made by the Company in response to market conditions, including estimated launch dates of competing products and declines in market price. The Company records an estimate for shelf-stock adjustments in the period it agrees to grant such a credit memo to a customer.
|
•
|
Cash Discounts - The Company offers cash discounts to its customers, generally
2%
to
3%
of the gross selling price, as an incentive for paying within invoice terms, which generally range from
30
to
90
days. An estimate of cash discounts is recorded in the same period when revenue is recognized.
|
•
|
Medicaid and Other U.S. Government Pricing Programs - As required by law, the Company provides a rebate on drugs dispensed under the Medicaid program, Medicare Part D, TRICARE, and other U.S. government pricing programs. The Company determines its estimated government rebate accrual primarily based on historical experience of claims submitted by the various states and other jurisdictions and any new information regarding changes in the various programs which may impact the Company’s estimate of government rebates. In determining the appropriate accrual amount, the Company considers historical payment rates and processing lag for outstanding claims and payments. The Company records estimates for government rebates as a deduction from gross sales, with a corresponding adjustment to accrued liabilities.
|
•
|
Level 1
- Inputs are quoted prices for identical instruments in active markets.
|
•
|
Level 2
- Inputs are quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.
|
•
|
Level 3
- Inputs are unobservable and reflect the Company's own assumptions, based on the best information available, including the Company's own data.
|
|
As of March 31, 2018
|
||||||||||||||||||
|
|
|
|
|
Fair Value Measurement Based on
|
||||||||||||||
|
Carrying
Amount |
|
Fair Value
|
|
Quoted Prices in Active Markets
(Level 1) |
|
Significant
Other Observable Inputs (Level 2) |
|
Significant Unobservable
Inputs (Level 3) |
||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
||||||||||
Deferred Compensation Plan asset
(1)
|
$
|
42,594
|
|
|
$
|
42,594
|
|
|
$
|
—
|
|
|
$
|
42,594
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
||||||||||
Term Loan Facility due August 2021, current portion
(2)
|
$
|
20,000
|
|
|
$
|
20,000
|
|
|
$
|
—
|
|
|
$
|
20,000
|
|
|
$
|
—
|
|
Term Loan Facility due August 2021, long-term portion
(2)
|
$
|
300,000
|
|
|
$
|
300,000
|
|
|
$
|
—
|
|
|
$
|
300,000
|
|
|
$
|
—
|
|
2% Convertible Senior Notes due June 2022
(3)
|
$
|
600,000
|
|
|
$
|
597,000
|
|
|
$
|
597,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Deferred Compensation Plan liabilities
(1)
|
$
|
33,899
|
|
|
$
|
33,899
|
|
|
$
|
—
|
|
|
$
|
33,899
|
|
|
$
|
—
|
|
Contingent consideration
(4)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
As of December 31, 2017
|
||||||||||||||||||
|
|
|
|
|
Fair Value Measurement Based on
|
||||||||||||||
|
Carrying
Amount |
|
Fair Value
|
|
Quoted Prices in Active Markets
(Level 1) |
|
Significant
Other Observable Inputs (Level 2) |
|
Significant Unobservable
Inputs (Level 3) |
||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
||||||||||
Deferred Compensation Plan asset
(1)
|
$
|
43,023
|
|
|
$
|
43,023
|
|
|
$
|
—
|
|
|
$
|
43,023
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
||||||||||
Term Loan Facility due August 2021, current portion
(2)
|
$
|
20,000
|
|
|
$
|
20,000
|
|
|
$
|
—
|
|
|
$
|
20,000
|
|
|
$
|
—
|
|
Term Loan Facility due August 2021, long-term portion
(2)
|
$
|
305,000
|
|
|
$
|
305,000
|
|
|
$
|
—
|
|
|
$
|
305,000
|
|
|
$
|
—
|
|
2% Convertible Senior Notes due June 2022
(3)
|
$
|
600,000
|
|
|
$
|
579,378
|
|
|
$
|
579,378
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Deferred Compensation Plan liabilities
(1)
|
$
|
33,413
|
|
|
$
|
33,413
|
|
|
$
|
—
|
|
|
$
|
33,413
|
|
|
$
|
—
|
|
Contingent consideration
(4)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
(1)
|
The Deferred Compensation Plan liabilities are non-current liabilities recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense in the Company’s consolidated statements of operations. The calculation of the Deferred Compensation Plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants and is included in the line items captioned “Other non-current liabilities” on the Company’s consolidated balance sheets. The Company invests participant contributions in corporate-owned life insurance policies (COLIs), for which the cash surrender value is included in the line item captioned “Other non-current assets” on the Company’s consolidated balance sheets.
|
(2)
|
The difference between the amount shown as the carrying value in the above tables and the amount shown on the Company’s consolidated balance sheets at
March 31, 2018
and
December 31, 2017
represents the unaccreted discount related to deferred debt issuance costs.
|
(3)
|
The difference between the amount shown as the carrying value in the above tables and the amount shown on the Company’s consolidated balance sheets at
March 31, 2018
and
December 31, 2017
represents the unaccreted discounts related to deferred debt issuance costs and bifurcation of the conversion feature of the notes.
|
(4)
|
Under the terms of the Termination Agreement which was effective August 3, 2016 and was executed as part of our acquisition of certain assets from Teva Pharmaceuticals USA, Inc. and Allergan plc, the ("Teva Transaction"). the Company could be contractually obligated to make payments up to
$40.0 million
based on the achievement of certain commercial and time-based milestones associated with is methylphenidate hydrochloride product. A discounted cash flow calculation model was used to value the contingent consideration using significant unobservable inputs, including the probability and timing of successful product launch, the expected number of product competitors in the market at the time of launch (as defined in the Termination Agreement) and the expected number of such competitors in the market o the one-year launch anniversary date. The Company conducted a review of the underlying inputs and assumptions at March 31, 2018 and December 31, 2017, and based on timing and probability of the product launch, and corresponding number of competitors expected to be in the market at both launch and the one-year anniversary of launch, the Company concluded that the fair value of its contingent consideration was
zero
.
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Gross accounts receivable
(1)
|
$
|
512,113
|
|
|
$
|
634,059
|
|
Less: Rebate reserve
|
(112,019
|
)
|
|
(181,611
|
)
|
||
Less: Chargeback reserve
|
(100,516
|
)
|
|
(136,891
|
)
|
||
Less: Distribution services reserve
|
(16,545
|
)
|
|
(11,037
|
)
|
||
Less: Discount reserve
|
(10,801
|
)
|
|
(14,344
|
)
|
||
Less: Uncollectible accounts reserve
(2)
|
(45,859
|
)
|
|
(49,423
|
)
|
||
Accounts receivable, net
|
$
|
226,373
|
|
|
$
|
240,753
|
|
(1)
|
Includes estimated
$44.3 million
as of
March 31, 2018
and
December 31, 2017
, receivable due from Turing Pharmaceuticals AG ("Turing") for reimbursement of Daraprim® chargebacks and Medicaid rebate liabilities pursuant to an Asset Purchase Agreement between the Company and Turing dated August 7, 2015 (the "Turing APA"). In accordance with the terms of the Turing APA and in accordance with federal laws and regulations, the Company receives, and is initially responsible for processing and paying (subject to reimbursement by Turing), all chargebacks and rebates resulting from utilization by Medicaid, Medicare and other federal, state and local government programs, health plans and other health care providers for products sold under the Company's labeler code. Under the terms of the Turing APA, Turing is responsible for liabilities related to chargebacks and rebates that arise as a result of Turing's marketing or selling related activities in connection with Daraprim®. Refer to "Note 18. Legal and Regulatory Matters" for a description of the Company's suit against Turing related to, among other matters, Turing's failure to reimburse the Company for chargebacks and Medicaid rebate liabilities when due.
|
(2)
|
As a result of the uncertainty of collection from Turing that developed during the first quarter of 2016, the Company recorded a reserve of
$48.0 million
as of March 31, 2016, which represented the full amount of the estimated receivable due from Turing. During the fourth quarter of 2016, the Company received a
$7.7 million
payment from Turing. During the three month period ended March 31, 2018, there were
no
changes to the
$44.3 million
estimated receivable due from Turing that was fully reserved.
|
|
Three Months Ended
|
|
Year Ended
|
||||
Rebate reserve
|
March 31, 2018
|
|
December 31, 2017
|
||||
Beginning balance
|
$
|
181,611
|
|
|
$
|
293,816
|
|
Provision recorded during the period for Impax Generics rebates
|
104,339
|
|
|
642,447
|
|
||
Credits issued during the period for Impax Generics rebates
|
(173,931
|
)
|
|
(754,652
|
)
|
||
Ending balance
|
$
|
112,019
|
|
|
$
|
181,611
|
|
|
Three Months Ended
|
|
Year Ended
|
||||
Chargeback reserve
|
March 31, 2018
|
|
December 31, 2017
|
||||
Beginning balance
|
$
|
136,891
|
|
|
$
|
151,978
|
|
Provision recorded during the period
|
248,590
|
|
|
1,212,039
|
|
||
Credits issued during the period
|
(284,965
|
)
|
|
(1,227,126
|
)
|
||
Ending balance
|
$
|
100,516
|
|
|
$
|
136,891
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
65,275
|
|
|
$
|
63,732
|
|
Work in process
|
12,510
|
|
|
3,046
|
|
||
Finished goods
|
94,272
|
|
|
104,187
|
|
||
Total inventory
|
172,057
|
|
|
170,965
|
|
||
Less: Non-current inventory
|
13,466
|
|
|
12,494
|
|
||
Total inventory - current
|
$
|
158,591
|
|
|
$
|
158,471
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Land
|
$
|
3,500
|
|
|
$
|
3,500
|
|
Buildings and improvements
|
94,608
|
|
|
96,775
|
|
||
Equipment
|
82,639
|
|
|
82,442
|
|
||
Office furniture and equipment
|
10,527
|
|
|
11,082
|
|
||
Construction-in-progress
|
46,990
|
|
|
46,622
|
|
||
Property, plant and equipment, gross
|
238,264
|
|
|
240,421
|
|
||
Less: Accumulated depreciation
|
(114,976
|
)
|
|
(115,608
|
)
|
||
Property, plant and equipment, net
|
$
|
123,288
|
|
|
$
|
124,813
|
|
|
|
Marketed Product Rights
|
|
IPR&D and Royalties
|
|
Total Company
|
||||||||||||
|
|
Gross Carrying Value
|
Accumulated Amortization
|
Intangible Assets, Net
|
|
Non-amortized Value
|
|
Intangible Assets, Net
|
||||||||||
Balance as of December 31, 2017
|
|
$
|
430,009
|
|
$
|
(205,545
|
)
|
$
|
224,464
|
|
|
$
|
38,003
|
|
|
$
|
262,467
|
|
Additions
|
|
—
|
|
—
|
|
—
|
|
|
1,000
|
|
|
1,000
|
|
|||||
Amortization
|
|
—
|
|
(14,473
|
)
|
(14,473
|
)
|
|
—
|
|
|
(14,473
|
)
|
|||||
Balance as of March 31, 2018
|
|
$
|
430,009
|
|
$
|
(220,018
|
)
|
$
|
209,991
|
|
|
$
|
39,003
|
|
|
$
|
248,994
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Payroll-related expenses
|
$
|
16,267
|
|
|
$
|
38,415
|
|
Product returns
|
80,781
|
|
|
76,293
|
|
||
Accrued shelf stock
|
13,165
|
|
|
7,525
|
|
||
Government rebates
|
52,934
|
|
|
73,970
|
|
||
Accrued litigation settlements
(1)
|
51,900
|
|
|
4,900
|
|
||
Legal and professional fees
|
12,185
|
|
|
14,005
|
|
||
Estimated Teva and Allergan chargebacks and rebates
(2)
|
13,277
|
|
|
13,277
|
|
||
Accrued profit sharing and royalty expenses
|
11,713
|
|
|
8,373
|
|
||
Other
|
16,454
|
|
|
11,369
|
|
||
Total accrued expenses
|
$
|
268,676
|
|
|
$
|
248,127
|
|
(1)
|
See “Note 18. Legal and Regulatory Matters” for a description of the claims and settlements.
|
(2)
|
In connection with our August 2016 acquisition of certain assets from Teva Pharmaceuticals USA, Inc. ("Teva") and Allergan plc ("Allergan") in the Teva Transaction, the Company agreed to manage the payment process for certain commercial chargebacks and rebates on behalf of Teva and Allergan related to products each of Teva and Allergan sold into the channel prior to the Company's acquisition of the products. On August 18, 2016, the Company received a payment totaling
$42.4 million
from Teva and Allergan, which represented their combined estimate of the amount of commercial chargebacks and rebates to be paid by the Company on their behalf to wholesalers who purchased products from Teva and Allergan prior to the closing. Pursuant to the agreed upon transition services, Teva and Allergan are obligated to reimburse the Company for additional payments related to chargebacks and rebates for products they sold into the channel prior to the closing and made on their behalf in excess of the
$42.4 million
. If the total payments made by the Company on behalf of Teva and Allergan are less than
$42.4 million
, the Company is obligated to refund the difference to Teva and/or Allergan. As of
March 31, 2018
, the Company had paid
$29.1 million
related to chargebacks and rebates on behalf of Teva and/or Allergan as described above and
$13.3 million
remained in accrued expenses on the Company's consolidated balance sheet.
|
|
Three Months Ended
|
|
Year Ended
|
||||
Returns reserve
|
March 31, 2018
|
|
December 31, 2017
|
||||
Beginning balance
|
$
|
76,293
|
|
|
$
|
72,888
|
|
Provision related to sales recorded in the period
|
19,709
|
|
|
47,709
|
|
||
Credits issued during the period
|
(15,221
|
)
|
|
(44,304
|
)
|
||
Ending balance
|
$
|
80,781
|
|
|
$
|
76,293
|
|
(i)
|
If during any calendar quarter commencing after the quarter ending September 30, 2015 (and only during such calendar quarter) the last reported sale price of the Company’s common stock for at least
20
trading days (whether or not consecutive) during a period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than
130%
of the conversion price on each applicable trading day; or
|
(ii)
|
If during the
five
business day period after any
10
consecutive trading day period (the “measurement period”) in which the trading price per
$1,000
of principal amount of Notes for each trading day of the measurement period was less than
98%
of the product of the last report sale price of the Company’s common stock and the conversion rate on each such trading day; or
|
(iii)
|
Upon the occurrence of corporate events specified in the Indenture.
|
Shares issued
|
74,081
|
|
Stock options outstanding
(1)
|
3,042
|
|
Conversion of Notes payable
(2)
|
9,471
|
|
Warrants outstanding (see below)
|
9,471
|
|
Total shares of common stock issued and reserved for issuance
|
96,065
|
|
|
Three Months Ended March 31,
|
|
||||||
|
2018
|
|
2017
|
|
||||
Basic Loss Per Common Share:
|
|
|
|
|
||||
Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
|
Weighted-average common shares outstanding
|
72,266
|
|
|
71,594
|
|
|
||
Basic loss per share
|
$
|
(1.81
|
)
|
|
$
|
(1.37
|
)
|
|
|
|
|
|
|
||||
Diluted Loss Per Common Share:
|
|
|
|
|
||||
Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
|
Add-back of interest expense on outstanding convertible notes payable, net of tax
|
—
|
|
(1)
|
—
|
|
(1)
|
||
Adjusted net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding
|
72,266
|
|
|
71,594
|
|
|
||
Weighted-average incremental shares related to assumed exercise of warrants and stock options, vesting of non-vested shares and ESPP share issuance
|
—
|
|
(2)
|
—
|
|
(2)
|
||
Weighted-average incremental shares assuming conversion of outstanding notes payable
|
—
|
|
(1)
|
—
|
|
(1)
|
||
Diluted weighted-average common shares outstanding
|
72,266
|
|
(2)
|
71,594
|
|
(2)
|
||
Diluted loss per share
|
$
|
(1.81
|
)
|
|
$
|
(1.37
|
)
|
|
(1)
|
For the three months ended
March 31, 2018
and 2017, the Company incurred a net loss, which cannot be diluted, so basic and diluted loss per common share were the same. Accordingly, there were no numerator or denominator adjustments related to the Company’s outstanding Notes.
|
(2)
|
For the three months ended
March 31, 2018
and 2017, the Company incurred a net loss, which cannot be diluted, so basic and diluted loss per common share were the same. As of
March 31, 2018
, shares issuable but not included in the Company's calculation of diluted EPS, which could potentially dilute future earnings, included
9.47 million
warrants outstanding,
9.47 million
shares for conversion of outstanding Notes payable,
3.04 million
stock options outstanding and
1.56 million
non-vested restricted stock awards. As of
March 31, 2017
, shares issuable but not included in the Company's calculation of diluted EPS, which could potentially dilute future earnings, include
9.47 million
warrants outstanding,
9.47 million
shares for conversion of outstanding Notes payable,
3.34 million
stock options outstanding and
2.21 million
non-vested restricted stock awards.
|
Stock Options
|
Number of
Shares Under Option |
|
Weighted-
Average Exercise Price per Share |
|||
Outstanding at December 31, 2017
|
3,174,997
|
|
|
$
|
18.36
|
|
Options exercised
|
(127,648
|
)
|
|
9.28
|
|
|
Options forfeited
|
(5,080
|
)
|
|
8.38
|
|
|
Outstanding at March 31, 2018
|
3,042,269
|
|
|
$
|
18.76
|
|
Options exercisable at March 31, 2018
|
1,875,982
|
|
|
$
|
20.08
|
|
Restricted Stock Awards
|
Number of
Restricted Stock Awards |
|
Weighted-
Average Grant Date Fair Value |
|||
Non-vested at December 31, 2017
|
1,861,489
|
|
|
$
|
25.36
|
|
Vested
|
(103,144
|
)
|
|
26.54
|
|
|
Forfeited
|
(197,661
|
)
|
|
26.15
|
|
|
Non-vested at March 31, 2018
|
1,560,684
|
|
|
$
|
25.19
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cost of revenues
|
$
|
520
|
|
|
$
|
1,584
|
|
Selling, general and administrative
|
3,196
|
|
|
1,423
|
|
||
Research and development
|
1,100
|
|
|
3,950
|
|
||
Total
|
$
|
4,816
|
|
|
$
|
6,957
|
|
•
|
Consolidating all of Generic R&D, U.S. manufacturing and packing operations to its Hayward, California facility;
|
•
|
Continuing the previously announced closure of the Middlesex, New Jersey manufacturing site, which will now include the closure of the Middlesex Generic R&D site as further discussed below under "Middlesex, New Jersey Manufacturing and Packaging Operations" and "Middlesex, New Jersey Generic R&D";
|
•
|
Reorganizing certain functions including quality, engineering and supply chain operations as further described below under "Technical Operations Reduction-in-Force";
|
•
|
Reviewing strategic alternatives for the Company’s Taiwan facility, including a sale of the facility as further described below under "Sale of Impax Laboratories (Taiwan), Inc." and
|
•
|
Rationalizing the generic portfolio to eliminate low-value products and streamline operations such as the Company's divestment during the second quarter of 2017 of
29
ANDAs and
one
NDA for approved non-strategic generic products, the vast majority of which were not marketed, and all acquired as part of the Tower Acquisition, as described above under "Note 8. Intangible Assets and Goodwill."
|
Type of Cost
|
Amount Incurred
|
||
Employee retention and severance payments
|
$
|
12,752
|
|
Technical transfer of products
|
9,716
|
|
|
Asset impairment and accelerated depreciation charges
|
20,900
|
|
|
Facilities lease terminations and asset retirement obligations
|
209
|
|
|
Legal and professional fees
|
9
|
|
|
Total estimated restructuring charges
|
$
|
43,586
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Employee retention and severance payments
|
|
$
|
25
|
|
|
$
|
1,480
|
|
Technical transfer of products
|
|
172
|
|
|
1,188
|
|
||
Asset impairment and accelerated depreciation charges
|
|
—
|
|
|
1,561
|
|
||
Facilities lease terminations and asset retirement obligations
|
|
—
|
|
|
93
|
|
||
Total
|
|
$
|
197
|
|
|
$
|
4,322
|
|
|
|
Balance as of
|
|
Expensed/
|
|
|
|
|
|
Balance as of
|
||||||||||
|
|
December 31, 2017
|
|
Accrued Expense
|
|
Cash Payments
|
|
Non-Cash Items
|
|
March 31, 2018
|
||||||||||
Employee retention and severance payments
|
|
$
|
7,386
|
|
|
$
|
25
|
|
|
$
|
(7,073
|
)
|
|
$
|
—
|
|
|
$
|
338
|
|
Technical transfer of products
|
|
—
|
|
|
172
|
|
|
(172
|
)
|
|
—
|
|
|
—
|
|
|||||
Legal and professional fees
|
|
209
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
209
|
|
|||||
Total
|
|
$
|
7,595
|
|
|
$
|
197
|
|
|
$
|
(7,245
|
)
|
|
$
|
—
|
|
|
$
|
547
|
|
•
|
Designation of a development candidate
. Following the designation of a development candidate, generally, IND-enabling animal studies for a new development candidate take
12
to
18
months to complete.
|
•
|
Initiation of a Phase I clinical trial
. Generally, Phase I clinical trials take
one
to
two
years to complete.
|
•
|
Initiation or completion of a Phase II clinical trial
. Generally, Phase II clinical trials take
one
to
three
years to complete.
|
•
|
Initiation or completion of a Phase III clinical trial
. Generally, Phase III clinical trials take
two
to
four
years to complete.
|
•
|
Completion of a bioequivalence study
. Generally, bioequivalence studies take
three
months to
one
year to complete.
|
•
|
Filing or acceptance of regulatory applications for marketing approval such as a New Drug Application in the United States or Marketing Authorization Application in Europe
. Generally, it takes
six
to
12
months to prepare and submit regulatory filings and
two
months for a regulatory filing to be accepted for substantive review.
|
•
|
Marketing approval in a major market, such as the United States or Europe
. Generally it takes
one
to
three
years after an application is submitted to obtain approval from the applicable regulatory agency.
|
•
|
Marketing approval in a major market, such as the United States or Europe for a new indication of an already-approved product
. Generally it takes
one
to
three
years after an application for a new indication is submitted to obtain approval from the applicable regulatory agency.
|
•
|
First commercial sale in a particular market
,
such as in the United States or Europe
.
|
•
|
Product sales in excess of a pre-specified threshold, such as annual sales exceeding
$100.0 million
.
The amount of time to achieve this type of milestone depends on several factors including but not limited to the dollar amount of the threshold, the pricing of the product and the pace at which customers begin using the product.
|
Three Months Ended March 31, 2018
|
Impax
Generics |
|
Impax
Specialty Pharma |
|
Corporate
and Other |
|
Total
Company |
||||||||
Revenues, net
|
$
|
83,141
|
|
|
$
|
59,214
|
|
|
$
|
—
|
|
|
$
|
142,355
|
|
Cost of revenues
|
95,037
|
|
|
17,038
|
|
|
—
|
|
|
112,075
|
|
||||
Selling, general and administrative
|
7,556
|
|
|
17,620
|
|
|
32,147
|
|
|
57,323
|
|
||||
Research and development
|
9,616
|
|
|
2,680
|
|
|
—
|
|
|
12,296
|
|
||||
Litigation, settlements and related charges
|
84,597
|
|
|
940
|
|
|
—
|
|
|
85,537
|
|
||||
(Loss) income before income taxes
|
$
|
(113,665
|
)
|
|
$
|
20,936
|
|
|
$
|
(45,493
|
)
|
|
$
|
(138,222
|
)
|
Three Months Ended March 31, 2017
|
Impax
Generics |
|
Impax
Specialty Pharma |
|
Corporate
and Other |
|
Total
Company |
||||||||
Revenues, net
|
$
|
134,147
|
|
|
$
|
50,256
|
|
|
$
|
—
|
|
|
$
|
184,403
|
|
Cost of revenues
|
103,335
|
|
|
16,897
|
|
|
—
|
|
|
120,232
|
|
||||
Cost of revenues impairment charges
|
39,280
|
|
|
—
|
|
|
—
|
|
|
39,280
|
|
||||
Selling, general and administrative
|
6,468
|
|
|
16,330
|
|
|
24,257
|
|
|
47,055
|
|
||||
Research and development
|
17,396
|
|
|
5,093
|
|
|
—
|
|
|
22,489
|
|
||||
In-process research and development impairment charges
|
6,079
|
|
|
—
|
|
|
—
|
|
|
6,079
|
|
||||
Litigation, settlements and related charges
|
368
|
|
|
704
|
|
|
—
|
|
|
1,072
|
|
||||
(Loss) income before income taxes
|
$
|
(38,779
|
)
|
|
$
|
11,232
|
|
|
$
|
(39,983
|
)
|
|
$
|
(67,530
|
)
|
Segment
|
|
Product Family
|
|
Three Months Ended March 31, 2018
|
|
||||
|
|
|
|
$
|
%
|
|
|||
Impax Specialty Pharma
|
|
Rytary® family
|
|
$
|
26,508
|
|
19
|
%
|
(1)
|
Impax Generics
|
|
Epinephrine Auto-Injector family (generic Adrenaclick®)
|
|
$
|
14,783
|
|
10
|
%
|
(2)
|
Impax Specialty Pharma
|
|
Albenza family
|
|
$
|
13,607
|
|
10
|
%
|
(3)
|
Impax Specialty Pharma
|
|
Oxymorphone HCI ER family
|
|
$
|
13,387
|
|
9
|
%
|
(4)
|
Impax Specialty Pharma
|
|
Zomig® family
|
|
$
|
10,478
|
|
7
|
%
|
(5)
|
Segment
|
|
Product Family
|
|
Three Months Ended March 31, 2017
|
|
||||
|
|
|
|
$
|
%
|
|
|||
Impax Generics
|
|
Epinephrine Auto-Injector family (generic Adrenaclick®)
|
|
$
|
20,318
|
|
11
|
%
|
(2)
|
Impax Generics
|
|
Rytary® family
|
|
$
|
19,905
|
|
11
|
%
|
(1)
|
Impax Specialty Pharma
|
|
Oxymorphone HCI ER family
|
|
$
|
18,970
|
|
10
|
%
|
(4)
|
Impax Specialty Pharma
|
|
Budesonide family
|
|
$
|
15,827
|
|
9
|
%
|
(6)
|
Impax Generics
|
|
Amphetamine Salts ER (CII) family (generic Adderall®)
|
|
$
|
12,173
|
|
7
|
%
|
(7)
|
|
|
|
||
(in thousands, except share and per share amounts)
|
|
Quarter Ended March 31, 2018
|
||
Revenue:
|
|
|
||
Impax Generics, gross
|
|
$
|
474,043
|
|
Less:
|
|
|
||
Chargebacks
|
|
240,041
|
|
|
Rebates
|
|
104,339
|
|
|
Product Returns
|
|
16,174
|
|
|
Other credits
|
|
31,329
|
|
|
Impax Generic Product sales, net
|
|
82,160
|
|
|
|
|
|
||
Rx Partner
|
|
909
|
|
|
Other Revenues
|
|
72
|
|
|
Impax Generic Division revenues, net
|
|
83,141
|
|
|
|
|
|
||
Impax Specialty Pharma, gross
|
|
97,215
|
|
|
Less:
|
|
|
||
Chargebacks
|
|
8,548
|
|
|
Rebates
|
|
5,601
|
|
|
Product Returns
|
|
3,535
|
|
|
Other credits
|
|
20,317
|
|
|
Impax Specialty Pharma, net
|
|
59,214
|
|
|
|
|
|
||
Total revenues
|
|
142,355
|
|
|
|
|
|
||
Gross Profit
|
|
30,280
|
|
|
|
|
|
||
Net Loss
|
|
$
|
(130,932
|
)
|
|
|
|
||
Net loss per common share:
|
|
|
||
Basic
|
|
$
|
(1.81
|
)
|
Diluted
|
|
$
|
(1.81
|
)
|
|
|
|
||
Weighted-average common shares outstanding:
|
|
|
||
Basic
|
|
72,265,794
|
|
|
Diluted
|
|
72,265,794
|
|
(in thousands, except share and per share amounts)
|
|
Quarter Ended March 31, 2017
|
||
Revenue:
|
|
|
||
Impax Generics, gross
|
|
$
|
630,672
|
|
Less:
|
|
|
||
Chargebacks
|
|
298,744
|
|
|
Rebates
|
|
164,792
|
|
|
Product Returns
|
|
9,733
|
|
|
Other credits
|
|
28,481
|
|
|
Impax Generic Product sales, net
|
|
128,922
|
|
|
|
|
|
||
Rx Partner
|
|
5,159
|
|
|
Other Revenues
|
|
66
|
|
|
Impax Generic Division revenues, net
|
|
134,147
|
|
|
|
|
|
||
Impax Specialty Pharma, gross
|
|
84,133
|
|
|
Less:
|
|
|
||
Chargebacks
|
|
9,828
|
|
|
Rebates
|
|
4,483
|
|
|
Product Returns
|
|
1,844
|
|
|
Other credits
|
|
17,722
|
|
|
Impax Specialty Pharma, net
|
|
50,256
|
|
|
|
|
|
||
Other Revenues
|
|
—
|
|
|
Impax Specialty Pharma, net
|
|
50,256
|
|
|
|
|
|
||
Total revenues
|
|
184,403
|
|
|
|
|
|
||
Gross profit
|
|
24,891
|
|
|
|
|
|
||
Net loss
|
|
$
|
(98,431
|
)
|
|
|
|
||
Net loss per common share:
|
|
|
||
Basic
|
|
$
|
(1.37
|
)
|
Diluted
|
|
$
|
(1.37
|
)
|
|
|
|
||
Weighted-average common shares outstanding:
|
|
|
||
Basic
|
|
71,594,472
|
|
|
Diluted
|
|
71,594,472
|
|
•
|
Shares of Impax common stock ceased trading on the NASDAQ Global Select Market (“Nasdaq”) at the close of business on May 4, 2018. On May 4, 2018, Nasdaq filed a notification on Form 25 with the SEC with respect to shares of Impax common stock to request removal of Impax common stock from listing on the NASDAQ and from registration under Section 12(b) of the Securities and Exchange Act of 1934, as amended.
|
•
|
In accordance with the terms of the BCA, in connection with the Closing on May 4, 2018, (i) each share of Impax common stock was cancelled and automatically converted into the right to receive
one
fully paid and nonassessable share of Class A common stock of Amneal Pharmaceuticals, Inc. (“Class A Common Stock”); (ii) approximately
1.3 million
of Impax common stock issued with respect to unvested restricted stock awards issued and outstanding immediately prior to the Closing were fully vested and exchanged for shares of Class A Common Stock; and (iii) approximately
3.0 million
outstanding stock options issued under the Impax equity plans or as inducement grants outstanding immediately prior to the Closing were fully vested and exchanged into for options to acquire a number of shares of Class A Common Stock equal to the number of shares of Impax Common Stock subject to such Impax Option immediately prior to the Closing at a price per share equal to the exercise price per share of Impax common stock otherwise purchasable pursuant to such Impax option.
|
•
|
In connection with the Closing, the Company repaid in full all outstanding amounts under its Amended and Restated Credit Agreement, dated as of August 3, 2016 and as amended on March 27, 2017 by and among Impax, Royal Bank of Canada, as administrative agent and collateral agent, and the lenders and other parties from time to time party thereto (the “Credit Agreement”), and terminated the Credit Agreement and all commitments by the lenders to extent further credit thereunder.
|
•
|
In connection with the Closing, on May 4, 2018, the Company, Amneal Pharmaceuticals, Inc. and Wilmington Trust, National Association, as trustee (the “Trustee”), entered into the Second Supplemental Indenture (the “Second Supplemental Indenture”) with respect to the Indenture dated as of June 30, 2015 (the “Indenture”), as amended by the First Supplemental Indenture dated as of November 6, 2017, governing the Company’s
2.00%
Convertible Senior Notes due 2022 (the “Notes”). The Second Supplemental Indenture (x) made New Amneal a party to the Indenture and (y) changed the right to convert each $1,000 principal amount of the Notes into a right to convert such principal amount of Notes into shares of Class A Common Stock, cash or a combination of cash and shares of Class A Common Stock, at the Company’s election, in each case reflecting a conversion rate of 15.7853 shares of Class A Common Stock per $1,000 principal amount of Notes surrendered for conversion.
|
•
|
As of May 4, 2018 and subsequent to that date, certain executives separated from their respective positions at Impax. Each of these separations constituted a termination of employment by Impax without cause following a change of control for purposes of the executives’ respective employment agreements. These executives will receive certain termination benefits during the second quarter in accordance with their employment agreements.
|
|
Three Months Ended March 31,
|
|
Increase / (Decrease)
|
|||||||||||
|
2018
|
|
2017
|
|
Dollars
|
|
Percentage
|
|||||||
Total revenues
|
$
|
142,355
|
|
|
$
|
184,403
|
|
|
$
|
(42,048
|
)
|
|
(23
|
)%
|
Gross profit
|
30,280
|
|
|
24,891
|
|
|
5,389
|
|
|
22
|
%
|
|||
Loss from operations
|
(124,876
|
)
|
|
(51,804
|
)
|
|
(73,072
|
)
|
|
*
|
|
|||
Loss before income taxes
|
(138,222
|
)
|
|
(67,530
|
)
|
|
(70,692
|
)
|
|
*
|
|
|||
(Benefit from) provision for income taxes
|
(7,290
|
)
|
|
30,901
|
|
|
(38,191
|
)
|
|
*
|
|
|||
Net loss
|
$
|
(130,932
|
)
|
|
$
|
(98,431
|
)
|
|
$
|
(32,501
|
)
|
|
(33
|
)%
|
|
Three Months Ended March 31,
|
|
Increase / (Decrease)
|
|||||||||||
|
2018
|
|
2017
|
|
Dollars
|
|
Percentage
|
|||||||
Revenues:
|
|
|
|
|
|
|
|
|||||||
Impax Generics, net
|
$
|
83,141
|
|
|
$
|
134,147
|
|
|
$
|
(51,006
|
)
|
|
(38
|
)%
|
Cost of revenues
|
95,037
|
|
|
103,335
|
|
|
(8,298
|
)
|
|
(8
|
)%
|
|||
Cost of revenues impairment charges
|
—
|
|
|
39,280
|
|
|
(39,280
|
)
|
|
*
|
|
|||
Gross loss
|
(11,896
|
)
|
|
(8,468
|
)
|
|
(3,428
|
)
|
|
(40
|
)%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
7,556
|
|
|
6,468
|
|
|
1,088
|
|
|
17
|
%
|
|||
Research and development
|
9,616
|
|
|
17,396
|
|
|
(7,780
|
)
|
|
(45
|
)%
|
|||
In-process research and development
impairment charges |
—
|
|
|
6,079
|
|
|
(6,079
|
)
|
|
*
|
|
|||
Litigation, settlements and related charges
|
84,597
|
|
|
368
|
|
|
84,229
|
|
|
*
|
|
|||
Total operating expenses
|
101,769
|
|
|
30,311
|
|
|
71,458
|
|
|
*
|
|
|||
Loss from operations
|
$
|
(113,665
|
)
|
|
$
|
(38,779
|
)
|
|
$
|
(74,886
|
)
|
|
*
|
|
|
Three Months Ended March 31,
|
|
Increase / (Decrease)
|
|||||||||||
|
2018
|
|
2017
|
|
Dollars
|
|
Percentage
|
|||||||
Revenues:
|
|
|
|
|
|
|
|
|||||||
Rytary®, net
|
$
|
26,508
|
|
|
$
|
19,905
|
|
|
$
|
6,603
|
|
|
33
|
%
|
Zomig®, net
|
10,478
|
|
|
9,857
|
|
|
621
|
|
|
6
|
%
|
|||
All other Specialty Pharma Products, net
|
22,228
|
|
|
20,494
|
|
|
1,734
|
|
|
8
|
%
|
|||
Total revenues
|
59,214
|
|
|
50,256
|
|
|
8,958
|
|
|
18
|
%
|
|||
Cost of revenues
|
17,038
|
|
|
16,897
|
|
|
141
|
|
|
1
|
%
|
|||
Gross profit
|
42,176
|
|
|
33,359
|
|
|
8,817
|
|
|
26
|
%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
17,620
|
|
|
16,330
|
|
|
1,290
|
|
|
8
|
%
|
|||
Research and development
|
2,680
|
|
|
5,093
|
|
|
(2,413
|
)
|
|
(47
|
)%
|
|||
Litigation, settlements and related charges
|
940
|
|
|
704
|
|
|
236
|
|
|
34
|
%
|
|||
Total operating expenses
|
21,240
|
|
|
22,127
|
|
|
(887
|
)
|
|
(4
|
)%
|
|||
Income from operations
|
$
|
20,936
|
|
|
$
|
11,232
|
|
|
$
|
9,704
|
|
|
86
|
%
|
|
Three Months Ended March 31,
|
|
Increase / (Decrease)
|
|||||||||||
|
2018
|
|
2017
|
|
Dollars
|
|
Percentage
|
|||||||
General and administrative expenses
|
$
|
32,147
|
|
|
$
|
24,257
|
|
|
$
|
7,890
|
|
|
33
|
%
|
Unallocated corporate expenses
|
(32,147
|
)
|
|
(24,257
|
)
|
|
(7,890
|
)
|
|
(33
|
)%
|
|||
Interest expense, net
|
(13,692
|
)
|
|
(13,226
|
)
|
|
(466
|
)
|
|
(4
|
)%
|
|||
Loss on sale of assets
|
(385
|
)
|
|
—
|
|
|
(385
|
)
|
|
*
|
|
|||
Loss on debt extinguishment
|
—
|
|
|
(1,215
|
)
|
|
1,215
|
|
|
*
|
|
|||
Other income (expense), net
|
731
|
|
|
(1,285
|
)
|
|
2,016
|
|
|
*
|
|
|||
Loss before income taxes
|
(45,493
|
)
|
|
(39,983
|
)
|
|
(5,510
|
)
|
|
(14
|
)%
|
|||
(Benefit from) provision for income taxes
|
$
|
(7,290
|
)
|
|
$
|
30,901
|
|
|
$
|
(38,191
|
)
|
|
*
|
|
(i)
|
If during any calendar quarter commencing after the quarter ending September 30, 2015 (and only during such calendar quarter) the last reported sale price of our common stock for at least
20
trading days (whether or not consecutive) during a period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than
130%
of the conversion price on each applicable trading day; or
|
(ii)
|
If during the
five
business day period after any
10
consecutive trading day period (the “measurement period”) in which the trading price per
$1,000
of principal amount of Notes for each trading day of the measurement period was less than
98%
of the product of the last report sale price of our common stock and the conversion rate on each such trading day; or
|
(iii)
|
Upon the occurrence of corporate events specified in the Indenture.
|
Period
|
|
Total Number of Shares (or Units) Purchased(1)
|
|
Average
Price Paid Per Share (or Unit) |
|
Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or programs
|
|||
January 1, 2018 to January 31, 2018
|
|
7,286
|
|
|
$17.33
|
|
—
|
|
|
—
|
|
February 1, 2018 to February 28, 2018
|
|
21,840
|
|
|
$20.95
|
|
—
|
|
|
—
|
|
March 1, 2018 to March 31, 2018
|
|
20,301
|
|
|
$19.51
|
|
—
|
|
|
—
|
|
(1)
|
Represents shares of our common stock that we accepted during the indicated periods as a tax withholding from certain of our employees in connection with the vesting of shares of restricted stock pursuant to the terms of our 2002 Plan.
|
Exhibit No.
|
|
Description of Document
|
|
Statement re computation of per share earnings (incorporated by reference to Note. 11 in the Notes to Interim Consolidated Financial Statements in this Quarterly Report on Form 10-Q).
|
|
|
|
|
|
Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
|
|
|
|
|
|
Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
|
|
|
|
|
|
Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
|
|
|
|
|
|
Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
|
|
|
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The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017, (ii) Consolidated Statements of Operations for each of the three months ended March 31, 2018 and 2017, (iii) Consolidated Statements of Comprehensive Loss for each of the three months ended March 31, 2018 and 2017, (iv) Consolidated Statements of Cash Flows for each of the three months ended March 31, 2018 and 2017 and (v) Notes to Interim Consolidated Financial Statements.*
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Date: May 10, 2018
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Impax Laboratories, LLC
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(Registrant)
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By:
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/s/ Robert Stewart
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Robert Stewart
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President and Chief Executive Officer
(Principal Executive Officer)
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By:
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/s/ Bryan M. Reasons
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Bryan M. Reasons
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Chief Financial Officer and
Senior Vice President, Finance
(Principal Financial and Accounting Officer)
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1.
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I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2018
of Impax Laboratories, LLC;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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May 10, 2018
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By:
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/s/ Robert Stewart
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Robert Stewart
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President and Chief Executive Officer
(Principal Executive Officer)
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1.
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I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2018
of Impax Laboratories, LLC;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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May 10, 2018
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By:
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/s/ Bryan M. Reasons
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Bryan M. Reasons
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Chief Financial Officer and Senior Vice President,
Finance
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(1)
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the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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May 10, 2018
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By:
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/s/ Robert Stewart
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Robert Stewart
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President and Chief Executive Officer
(Principal Executive Officer)
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(1)
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the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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May 10, 2018
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By:
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/s/ Bryan M. Reasons
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Bryan M. Reasons
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Chief Financial Officer and Senior Vice President, Finance
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