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8-K - FORM 8-K - Impax Laboratories, LLCipxl20150807_8k.htm
EX-99.2 - EXHIBIT 99.2 - Impax Laboratories, LLCex99-2.htm

Exhibit 99.1

 

 

 

Impax Reports Second Quarter 2015 Financial Results

 

 

—  Impax Revenues Increased 14% to $214 Million in Second Quarter 2015 —

 

—  Adjusted Diluted EPS of $0.34; GAAP Net Loss of $0.03 Per Diluted Share—

 

—  Announced Sale of Daraprim® for $55 Million —

 

—  Company Updates Full Year 2015 Financial Guidance —

 

HAYWARD, Calif., August 10, 2015 – Impax Laboratories, Inc. (NASDAQ: IPXL) today reported second quarter 2015 financial results for the period ending June 30, 2015.

 

Total revenues for the second quarter 2015 increased 14% to $214.2 million, compared to $188.1 million in the prior year period. The increase was primarily due to the addition of product revenues from the Company’s acquisition on March 9, 2015 of Tower Holdings, Inc. and Lineage Therapeutics Inc. (together with its subsidiaries, “Tower”), and sales from new brand and generic product launched in 2015.

 

Adjusted diluted earnings per share (EPS) for the second quarter of 2015 was $0.34, compared to the second quarter 2014 adjusted diluted EPS of $0.60. While total revenues increased in the second quarter 2015 as noted above, adjusted EPS decreased in the current year period primarily due to the absence of sales of high-margin authorized generic RENVELA® in the current period, compared to revenues of $49.1 million from the product in the second quarter 2014. Also impacting the second quarter 2015 results were higher interest expense in connection with the financing for the Company’s acquisition of Tower during the current period and a higher tax rate compared to the prior year period.

 

On a GAAP basis, the Company reported a loss of $0.03 per diluted share for the second quarter 2015, compared to income of $0.50 per diluted share in the prior year period. GAAP EPS during the current period was impacted by the items noted above, as well as a charge for loss on the extinguishment of debt and higher amortization expense in connection with the Tower acquisition during the current period.

 

Fred Wilkinson, President and Chief Executive Officer of Impax, stated, “We delivered strong revenue growth in the second quarter driven by the addition of product sales from the Tower acquisition, as well as solid execution of recent product launches. The addition of the Tower generic product line coupled with the recent launch of six products from the Generics division more than offset the lost sales of authorized generic RENVELA during the quarter. Our Specialty Pharma division achieved profitability for the first time in two years as revenues more than tripled to $39.5 million compared to the same period last year, driven by the launch of RYTARY®, continued growth of Zomig® Nasal Spray and the addition of the brand products from Tower.”

 

“Although total Company revenues increased by almost 14% in the second quarter, the overall gross margin declined primarily due to the addition of new generic products with lower margins compared to the margin of authorized generic RENVELA. Gross margin was also impacted by lower sales of our epinephrine auto-injector product during the current quarter due to a temporary supply disruption from our supplier. We have resolved the supply shortage and are in the process of re-stocking our customers. While we currently expect our gross margin to improve during the second half of 2015, we have revised our full year 2015 gross margin guidance from the previously stated mid 50% range to the low 50% range as a result of the product sales mix in the first half of this year.”

 

 

 
Page 1 of 16

 

 

“The integration of the Tower acquisition is essentially complete. We continue to focus on achieving the strategic benefits of this transaction and the previously identified synergies of approximately $20 million by the end of 2016. Our attention will now be aimed at improving our supply chain by increasing the efficiency of our internal and external network which is intended to improve product flow and capture cost efficiencies.”

 

“This morning we announced the sale of Daraprim®, a non-core asset we acquired in the Tower acquisition, for $55 million, recovering approximately 8% of the $700 million acquisition price. In late June, we adjusted our capital structure by issuing a convertible bond offering with a 2% coupon and terminated our term loan which had a floating interest rate of 5.5%, resulting in significant annual cash interest savings. The adjusted capital structure and the proceeds from the asset sale provide additional resources and balance sheet flexibility to pursue strategic growth opportunities,” Mr. Wilkinson concluded.

 

Business Segment Information

 

The Company has two reportable segments, the Impax Generics Division (generic products and services) and the Impax Specialty Pharma Division (brand products and services) and does not allocate general corporate services to either segment. All information presented is on a GAAP basis unless otherwise noted on an adjusted basis.

 

 
Page 2 of 16

 

 

Impax Generics Division Information

(Unaudited, amounts in thousands)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Revenues:

                               

Impax Generics Product sales, net

  $ 171,273     $ 163,961     $ 297,232     $ 270,078  

Rx Partner

    2,579       9,204       4,818       11,639  

Other revenues

    827       3,229       1,370       3,817  

Total revenues

    174,679       176,394       303,420       285,534  

Cost of revenues

    110,767       69,872       186,880       126,894  

Gross profit

    63,912       106,522       116,540       158,640  

Operating expenses:

                               

Research and development

    12,891       10,745       23,754       21,962  

Patent litigation expense

    1,332       1,767       2,110       3,940  

Selling, general and administrative

    7,284       4,572       11,570       6,955  

Total operating expenses

    21,507       17,084       37,434       32,857  

Income from operations

  $ 42,405     $ 89,438     $ 79,106     $ 125,783  
                                 

Gross margin

    36.6 %     60.4 %     38.4 %     55.6 %

Adjusted gross profit (a)

  $ 75,215     $ 117,219     $ 133,483     $ 183,108  

Adjusted gross margin (a)

    43.1 %     66.5 %     44.0 %     64.1 %

 

(a) Adjusted gross profit is calculated as total revenues less adjusted cost of revenues. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. Refer to the "Non-GAAP Financial Measures" for a reconciliation of GAAP to non-GAAP items.

 

Total revenues for the Impax Generics division decreased $1.7 million to $174.7 million in the second quarter 2015, compared to $176.4 million in the prior year period. The decrease was primarily due to the absence of authorized generic RENVELA sales during the current period compared to revenues of $49.1 million in the second quarter 2014, and significantly lower sales of generic digoxin as a result of additional competition during the current period. Also, Rx Partner and other generic revenues declined $9.0 million in the second quarter 2015, compared to the prior year period, primarily due to the receipt of $9.0 million in the second quarter 2014 from profit share and milestone payments earned pursuant to agreements with a couple of third-party pharmaceutical companies for which there were no comparable amounts in the current year period. The decrease in total revenues was partially offset by the addition of product sales from the Tower acquisition and sales from six generic products launched during the second quarter 2015.

 

Gross margin in the second quarter 2015 decreased to 36.6%, compared to gross margin of 60.4% in the prior year period. Adjusted gross margin in the second quarter 2015 decreased to 43.1%, compared to adjusted gross margin of 66.5% in the prior year period. The decrease in gross margin and adjusted gross margin was primarily the result of the favorable contribution from sales of authorized generic RENVELA in the second quarter 2014 for which there were no sales in the current quarter. In addition, the lower gross margin and adjusted gross margin in the second quarter 2015 was due to the current year impact of higher sales of lower margin generic products, additional competition on generic digoxin, and the temporary supply disruption of the epinephrine auto-injector product as noted above.

 

 

 
Page 3 of 16

 

 

Total operating expenses in the second quarter 2015 increased to $21.5 million, compared to $17.1 million in the prior year period, primarily due to higher selling, general and administrative expenses and research and development expenses.

 

Impax Specialty Pharma Division Information

(Unaudited, amounts in thousands)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Revenues:

                               

Impax Specialty Pharma Product sales, net

  $ 39,275     $ 11,460     $ 53,403     $ 20,769  

Other revenues

    228       267       455       536  

Total revenues

    39,503       11,727       53,858       21,305  

Cost of revenues

    18,564       8,477       26,313       12,551  

Gross profit

    20,939       3,250       27,545       8,754  

Operating expenses:

                               

Research and development

    4,104       10,507       8,203       21,031  

Patent litigation expense

    162       -       344       -  

Selling, general and administrative

    12,912       11,734       27,768       20,955  

Total operating expenses

    17,178       22,241       36,315       41,986  

Income (loss) from operations

  $ 3,761     $ (18,991 )   $ (8,770 )   $ (33,232 )
                                 

Gross margin

    53.0 %     27.7 %     51.1 %     41.1 %

Adjusted gross profit (a)

  $ 31,837     $ 3,980     $ 41,362     $ 10,214  

Adjusted gross margin (a)

    80.6 %     33.9 %     76.8 %     47.9 %

 

(a) Adjusted gross profit is calculated as total revenues less adjusted cost of revenues. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. Refer to the "Non-GAAP Financial Measures" for a reconciliation of GAAP to non-GAAP items.

 

Total revenue for the Impax Specialty Pharma division increased $27.8 million to $39.5 million in the second quarter 2015, compared to $11.7 million in the prior year period, due to the launch of RYTARY at the end of the first quarter 2015 and the addition of product sales from the Tower acquisition.

 

Gross margin in the second quarter 2015 increased to 53.0%, compared to 27.7% in the prior year period, due to new product sales as noted above. Gross margins during the prior year period included the impact of a $3.6 million reserve for pre-launch inventory related to RYTARY as a result of a Complete Response Letter received in 2014 for which there was no similar amounts included in cost of revenues in the current year period. Adjusted gross margin in the second quarter 2015 increased to 80.6%, compared to adjusted gross margin of 33.9% in the prior year period, primarily due to the items noted above.

 

 

 
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Total operating expenses in the second quarter 2015 decreased to $17.2 million, compared to $22.2 million in the prior year period, as lower research and development expenses were partially offset by an increase in brand selling expenses relating to the launch of RYTARY.

 

Corporate and Other

(Unaudited, amounts in thousands)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

General and administrative expenses

  $ 28,113     $ 16,511     $ 59,131     $ 30,384  

Loss from operations

  $ (28,113 )   $ (16,511 )   $ (59,131 )   $ (30,384 )

  

General and administrative expenses in the second quarter 2015 increased $11.6 million to $28.1 million, compared to $16.5 million in the prior year period. The increase was primarily driven by business development expenses including integration-related activities from the Tower acquisition, the addition of expenses from the acquired companies, higher information technology costs, increased legal expenses and higher share-based compensation expense, compared to the prior year period.

 

Cash and cash equivalents were $190.3 million as of June 30, 2015, compared to $414.9 million as of December 31, 2014. The decrease was due to the cash used during the current period to pay the purchase price in the Tower acquisition.

 

Interest expense in the second quarter 2015 was $7.0 million, an increase of $7.0 million, compared to the prior year period, primarily related to borrowings under the Company’s $435 million senior secured term loan in connection with the Tower acquisition. Interest expense in the second quarter 2015 included $0.7 million in amortization of deferred financing costs. The term loan was repaid in its entirety and terminated on June 30, 2015.

 

The effective reported tax rate was 59.3% in the second quarter of 2015, compared with 35.6% in the prior year period as a result of a change in the timing and mix of U.S. and foreign income. The effective non-GAAP tax rate was 37.6% in the second quarter 2015, compared with 35.8% in the prior year period. Neither period includes the benefit of certain expired U.S. tax provisions, including the R&D tax credit.

 

 

 
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2015 Financial Guidance

 

The Company’s full year 2015 financial guidance has been updated as of August 10, 2015, as noted below. The Company’s full year 2015 estimates are based on management’s current belief about prescription trends, pricing levels, inventory levels, and the anticipated timing of future product launches and events. The Company’s estimates exclude the impact from any products for which the Company has not yet received approval from the U.S. Food and Drug Administration.

 

 

UPDATED - Adjusted gross margins as a percent of total revenue are expected to be in the low 50% range (previously mid 50% range).

 

UPDATED - Adjusted total research and development (R&D) expenses across the generic and brand divisions of approximately $75 million to $80 million (previously $80 million to $85 million). This includes patent litigation expenses.

 

Adjusted selling, general and administrative expenses of approximately $170 million to $180 million.

 

NEW - Adjusted interest expense of approximately $14 million.

 

Capital expenditures of approximately $45 million to $50 million.

 

Effective tax rate of approximately 34% to 36% on a GAAP basis, which assumes that the U.S. R&D tax credit is renewed for 2015. The R&D tax credit expired on December 31, 2014. The Company anticipates that its non-GAAP effective tax rate may experience volatility as the Company’s tax benefits may be high compared to the Company’s operating income or loss.

 

Conference Call Information 

 

The Company will host a conference call with a slide presentation on August 10, 2015 at 8:30 a.m. ET to discuss its results. The call and presentation can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 80278042. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers).

 

About Impax Laboratories, Inc.

 

Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com.

 

 

 
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"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

 

To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company’s ability to promptly correct the issues raised in the warning letter and Form 483 observations received from the FDA; the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the impact of competition; the Company’s ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements ; the Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the Company’s lack of a license partner for commercialization of IPX066 outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply chain; the Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions and investments; the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the acquisition, the retention of certain key employees of the acquired business being difficult, the Company’s and the acquired business’s expected or targeted future financial and operating performance and results, the combined company’s capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with the acquisition within the expected time-frames or at all, the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

 

 
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Company Contact:

Mark Donohue

Investor Relations and Corporate Communications

(215) 558-4526          

www.impaxlabs.com 

 

 
Page 8 of 16

 

 

Impax Laboratories, Inc.

Consolidated Statements of Operations

(unaudited, amounts in thousands, except share and per share data)

 

   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Revenues:

                               

Impax Generics, net

  $ 174,679     $ 176,394     $ 303,420     $ 285,534  

Impax Specialty Pharma, net

    39,503       11,727       53,858       21,305  

Total revenues

    214,182       188,121       357,278       306,839  

Cost of revenues

    129,331       78,349       213,193       139,445  

Gross profit

    84,851       109,772       144,085       167,394  

Operating expenses:

                               

Research and development

    16,995       21,252       31,957       42,993  

Patent litigation expense

    1,494       1,767       2,454       3,940  

Selling, general and administrative

    48,309       32,817       98,469       58,294  

Total operating expenses

    66,798       55,836       132,880       105,227  

Income from operations

    18,053       53,936       11,205       62,167  

Other income, net

    961       31       795       107  

Loss on extinguishment of debt

    (16,903 )     -       (16,903 )     -  

Interest income

    294       365       578       753  

Interest expense

    (6,953 )     93       (10,928 )     28  

(Loss) income before income taxes

    (4,548 )     54,425       (15,253 )     63,055  

(Benefit) provision for income taxes

    (2,696 )     19,354       (7,068 )     21,559  

Net (loss) income

  $ (1,852 )   $ 35,071     $ (8,185 )   $ 41,496  
                                 

Net (loss) income per share:

                               

Basic

  $ (0.03 )   $ 0.52     $ (0.12 )   $ 0.61  

Diluted

  $ (0.03 )   $ 0.50     $ (0.12 )   $ 0.59  
                                 

Weighted average common shares outstanding:

                               

Basic

    69,338,789       68,095,159       69,154,357       67,899,894  

Diluted

    69,338,789       70,313,491       69,154,357       70,195,329  

 

 
Page 9 of 16

 

 

Impax Laboratories, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

 

   

June 30,

   

December 31,

 
   

2015

   

2014

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 190,291     $ 214,873  

Short-term investments

    -       199,983  

Accounts receivable, net

    241,720       146,490  

Inventory, net

    123,433       80,570  

Deferred income taxes

    84,157       54,825  

Prepaid expenses and other assets

    63,416       33,710  

Total current assets

    703,017       730,451  

Property, plant and equipment, net

    214,630       188,169  

Derivative asset

    147,000       -  

Other assets

    69,942       106,292  

Intangible assets, net

    740,453       26,711  

Goodwill

    157,267       27,574  

Total assets

  $ 2,032,309     $ 1,079,197  
                 

Liabilities and Stockholders' Equity

               

Current liabilities:

               

Accounts payable and accrued expenses

  $ 184,013     $ 142,446  

Accrued profit sharing and royalty expenses

    41,655       15,346  

Deferred revenue

    907       907  

Total current liabilities

    226,575       158,699  

Long-term debt

    414,391       -  

Derivative liability

    167,000       -  

Deferred revenue

    2,949       3,403  

Deferred tax liability

    196,745       -  

Other liabilities

    36,964       29,218  

Total liabilities

    1,044,624       191,320  

Total stockholders' equity

    987,685       887,877  

Total liabilities and stockholders' equity

  $ 2,032,309     $ 1,079,197  

 

 

 

 
Page 10 of 16

 

 

Impax Laboratories, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited, amounts in thousands)

 

   

Six Months Ended

 
   

June 30,

 
   

2015

   

2014

 

Cash flows from operating activities:

               

Net (loss) income

  $ (8,185 )   $ 41,496  

Adjustments to reconcile net income to net cash (used in) provided by operating activities:

               

Depreciation and amortization

    30,714       16,303  

Provision for inventory reserves

    (6,597 )     10,320  

Intangible asset impairment charges

    -       2,876  

Charge for licensing agreement

    -       2,000  

Loss on early extinguishment of debt

    16,903       -  

Accretion of interest income on short-term investments

    (81 )     (421 )

Deferred income tax

    (9,464 )     (4,786 )

Tax impact related to the exercise of employee stock options

    (4,319 )     (1,507 )

Deferred revenue

    (454 )     (2,100 )

Accrued profit sharing and royalty expense

    62,193       23,582  

Payments of profit sharing and royalty expense

    (41,957 )     (22,063 )

Share-based compensation expense

    13,559       9,520  

Changes in assets and liabilities which used cash

    (84,897 )     (62,800 )

Net cash (used in) provided by operating activities

    (32,585 )     12,420  

Cash flows from investing activities:

               

Payment for acquisition, net of cash acquired

    (697,183 )     -  

Purchase of short-term investments

    -       (235,388 )

Maturities of short-term investments

    200,064       210,442  

Purchases of property, plant and equipment

    (8,482 )     (18,271 )

Proceeds from sale of assets

    4,000       -  

Payment for licensing agreement

    (5,550 )     (3,000 )

Net cash used in investing activities

    (507,151 )     (46,217 )

Cash flows from financing activities:

               

Proceeds from issuance of term loan, gross

    435,000       -  

Repayment of term loan

    (435,000 )     -  

Payment of deferred financing fees

    (36,440 )     -  

Proceeds from sale of convertible notes, net of issuance costs

    600,000       -  

Purchase of bond hedge derivative asset

    (147,000 )     -  

Proceeds from sale of warrants

    88,320       -  

Proceeds from exercise of stock options and ESPP

    5,383       7,660  

Tax impact related to the exercise of employee stock options and restricted stock

    4,319       1,507  

Net cash provided by financing activities

    514,582       9,167  

Effect of exchange rate changes on cash and cash equivalents

    572       (843 )

Net decrease in cash and cash equivalents

    (24,582 )     (25,473 )

Cash and cash equivalents, beginning of period

    214,873       184,612  

Cash and cash equivalents, end of period

  $ 190,291     $ 159,139  

 

 
Page 11 of 16

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

 

Adjusted net income, adjusted net income per diluted share, EBITDA, adjusted EBITDA, adjusted cost of revenues, adjusted research and development expenses and adjusted selling, general and administrative expenses are not measures of financial performance under generally accepted accounting principles (GAAP) and should not be construed as substitutes for, or superior to, GAAP net (loss) income, GAAP net income (loss) per diluted share, GAAP cost of revenues, GAAP research and development expenses and GAAP selling, general and administrative expenses as a measure of financial performance. However, management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the Company’s operations and to better understand its business. Further, management believes the addition of non-GAAP financial measures provides meaningful supplementary information to, and facilitates analysis by, investors in evaluating the Company’s financial performance, results of operations and trends. The Company’s calculations of adjusted net income, adjusted net income per diluted share, EBITDA, adjusted EBITDA, adjusted cost of revenues, adjusted research and development expenses and adjusted selling, general and administrative expenses, may not be comparable to similarly designated measures reported by other companies, since companies and investors may differ as to what type of events warrant adjustment.

 

The following table reconciles reported net (loss) income to adjusted net income.

(Unaudited, amounts in thousands, except per share and per share data)

 

   

Three months ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Net (loss) income

  $ (1,852 )   $ 35,071     $ (8,185 )   $ 41,496  

Adjusted to add (deduct):

                               

Amortization (a)

    12,622       2,594       16,908       5,024  

Hayward facility remediation costs(b)

    2,697       8,651       5,845       17,168  

Employee severance (c)

    2,643       182       5,054       860  

Intangible asset impairment charges (d)

    -       -       -       2,876  

Payment for licensing agreement (e)

    -       -       -       2,000  

Business development expenses (f)

    3,901       -       11,289       -  

Fair value of inventory step-up (g)

    4,239       -       5,363       -  

Ticking Fees (h)

    -       -       2,317       -  

Loss on extinguishment of debt (i)

    16,903       -       16,903       -  

Deferred financing costs (j)

    749       -       928       -  

Income tax effect

    (17,456 )     (4,204 )     (25,630 )     (10,649 )

Adjusted net income

  $ 24,446     $ 42,294     $ 30,792     $ 58,775  
                                 

Adjusted net income per diluted share

  $ 0.34     $ 0.60     $ 0.43     $ 0.84  

Net (loss) income per diluted share

  $ (0.03 )   $ 0.50     $ (0.12 )   $ 0.59  
                                 

Diluted weighted average common shares outstanding

    72,550,756       70,313,491       72,447,049       70,195,329  

 

 

 
Page 12 of 16

 

  

Impax Laboratories, Inc.

Non-GAAP Financial Measures

 

(a)

Primarily resulting from the March 2015 acquisition of Tower (including its operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC) and Lineage. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(b)

Remediation costs related to the Hayward, CA manufacturing facility. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(c)

Related to the closing of the Company’s packaging and distribution facilities. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(d)

During the first quarter 2014, as a result of a decline in pricing on a currently approved Tolmar product, the Company revised the projections for the product and performed an intangible asset impairment analysis. Based on the results of this analysis, the Company recorded a $2.9 million charge to cost of revenues. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(e)

In January 2014, the Company entered into an agreement with DURECT Corporation and paid an upfront fee of $2.0 million. Included in “Research and development” expense on the Consolidated Statements of Operations.

(f)

Professional fees related to business development activities including Tower integration-related activities. Included in “Selling, general and administrative” expenses on the Consolidated Statements of Operations.

(g)

Fair value adjustment of inventory as a result of purchase accounting for the Tower acquisition. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(h)

Fees incurred relating to the Company’s $435.0 million term loan to lock in the financing terms beginning from the lenders' commitment of the term loan to the actual allocation of the term loan upon the closing of the Tower transaction. Included in “Interest expense” on the Consolidated Statements of Operations.

(i)

Loss on the extinguishment and repayment of the $435.0 million term loan due to the write-off of $16.9 million of deferred financing costs. Included in on the Consolidated Statements of Operations.

(j)

Amortization of financing costs related to the Company’s $435.0 million term loan. Included in “Interest expense” on the Consolidated Statements of Operations.

 

 

 
Page 13 of 16

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

(Unaudited, amounts in thousands)

  

The following table reconciles reported net (loss) income to adjusted EBITDA.

 

   

Three months ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Net (loss) income

  $ (1,852 )   $ 35,071     $ (8,185 )   $ 41,496  

Adjusted to add (deduct):

                               

Interest income

    (294 )     (365 )     (578 )     (753 )

Interest expense

    6,953       (93 )     10,928       (28 )

Depreciation and other

    7,648       5,694       13,806       11,279  

Income taxes

    (2,696 )     19,354       (7,068 )     21,559  

EBITDA

    9,759       59,661       8,903       73,553  
                                 

Adjusted to add (deduct):

                               

Amortization

    12,622       2,594       16,908       5,024  

Hayward facility remediation costs

    2,697       8,651       5,845       17,168  

Employee severance

    2,643       182       5,054       860  

Intangible asset impairment charges

    -       -       -       2,876  

Payment for licensing agreement

    -       -       -       2,000  

Business development expenses

    3,901       -       11,289       -  

Fair value of inventory step-up

    4,239       -       5,363       -  

Loss on extinguishment of debt

    16,903       -       16,903       -  

Share-based compensation

    7,071       5,134       13,559       9,520  

Adjusted EBITDA

  $ 59,835     $ 76,222     $ 83,824     $ 111,001  

 

 
Page 14 of 16

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

(Unaudited, amounts in thousands)

 

The following table reconciles total Company reported cost of revenues, research and development expenses, and selling, general and administrative expenses to adjusted cost of revenues, adjusted gross profit, adjusted gross margin, adjusted research and development expenses, and adjusted selling, general and administrative expenses.

 

   

Three months ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Cost of revenues

  $ 129,331     $ 78,349     $ 213,193     $ 139,445  

Adjusted to deduct:

                               

Amortization

    12,622       2,594       16,908       5,024  

Hayward facility remediation costs

    2,697       8,651       5,845       17,168  

Employee severance

    2,643       182       2,643       860  

Intangible asset impairment charge

    -       -       -       2,876  

Fair value of inventory step-up

    4,239       -       5,363       -  

Adjusted cost of revenues

  $ 107,130     $ 66,922     $ 182,434     $ 113,517  
                                 

Adjusted gross profit (a)

  $ 107,052     $ 121,199     $ 174,844     $ 193,322  

Adjusted gross margin (a)

    50.0 %     64.4 %     48.9 %     63.0 %
                                 

Research and development expenses

  $ 16,995     $ 21,252     $ 31,957     $ 42,993  

Adjusted to deduct:

                               

Payment for licensing agreement

    -       -       -       2,000  

Adjusted research and development expenses

  $ 16,995     $ 21,252     $ 31,957     $ 40,993  
                                 

Selling, general and administrative expenses

  $ 48,309     $ 32,817     $ 98,469     $ 58,294  

Adjusted to deduct:

                               

Business development expenses

    3,901       -       11,289       -  

Employee severance

    -       -       2,411       -  

Adjusted selling, general and administrative expenses

  $ 44,408     $ 32,817     $ 84,769     $ 58,294  

 

(a)

Adjusted gross profit is calculated as total revenues less adjusted cost of revenues. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.

 

 

 

 
Page 15 of 16

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

(Unaudited, amounts in thousands)

 

The following tables reconcile the Impax Generics and Impax Specialty Pharma Divisions reported cost of revenues to adjusted cost of revenues, adjusted gross profit and adjusted gross margin.

 

Impax Generics Division Information

 

   

Three months ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Cost of revenues

  $ 110,767     $ 69,872     $ 186,880     $ 126,894  

Adjusted to deduct:

                               

Amortization

    5,238       1,864       7,455       3,564  

Hayward facility remediation costs

    2,697       8,651       5,845       17,168  

Employee severance

    2,643       182       2,643       860  

Intangible asset impairment charge

    -       -       -       2,876  

Fair value of inventory step-up

    725       -       1,000       -  

Adjusted cost of revenues

  $ 99,464     $ 59,175     $ 169,937     $ 102,426  
                                 

Adjusted gross profit (a)

  $ 75,215     $ 117,219     $ 133,483     $ 183,108  

Adjusted gross margin (a)

    43.1 %     66.5 %     44.0 %     64.1 %

 

 

Impax Specialty Pharma Division Information

 

   

Three months ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2015

   

2014

   

2015

   

2014

 

Cost of revenues

  $ 18,564     $ 8,477     $ 26,313     $ 12,551  

Adjusted to deduct:

                               

Amortization

    7,384       730       9,454       1,460  

Fair value of inventory step-up

    3,514       -       4,363       -  

Adjusted cost of revenues

  $ 7,666     $ 7,747     $ 12,496     $ 11,091  
                                 

Adjusted gross profit (a)

  $ 31,837     $ 3,980     $ 41,362     $ 10,214  

Adjusted gross margin (a)

    80.6 %     33.9 %     76.8 %     47.9 %

 

 

(a)

Adjusted gross profit is calculated as total revenues less adjusted cost of revenues. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.

Page 16 of 16