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8-K - FORM 8-K - Impax Laboratories, LLCipxl20140805_8k.htm

Exhibit 99.1

 

 

Impax’s Second Quarter 2014 Revenues Increased 45% to $188.1 Million

 

 

Second Quarter 2014 Adjusted Diluted EPS Increased to $0.60; GAAP Diluted EPS Increased to $0.50

 

Company Updates 2014 Financial Guidance

 

HAYWARD, Calif. (August 6, 2014) – Impax Laboratories, Inc. (NASDAQ: IPXL) today reported total revenues increased 45.1% to $188.1 million for the second quarter ended June 30, 2014, compared to $129.6 million in the prior year period. Adjusted diluted earnings per share increased to $0.60 for the second quarter 2014, compared to $0.23 per diluted share in the prior year period. On a GAAP basis, diluted earnings per share increased to $0.50 for the second quarter 2014, compared to $0.08 per diluted share in the prior year period.

 

Second quarter 2014 adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) increased $40.0 million to $76.2 million, compared to $36.2 million in the prior year period. Cash, cash equivalents and short-term investments were $413.0 million as of June 30, 2014.

 

“We delivered strong revenue growth of 45%, adjusted gross margins of 64%, and nearly tripled our adjusted net income this quarter, compared to last year’s second quarter” said Fred Wilkinson, president and chief executive officer of Impax Laboratories. “We experienced strong performance by several key generic products, including the successful launch of authorized generic RENVELA®, as well as continued growth of Zomig® nasal spray in our brand division.”

 

“We remain excited about the business development and M&A landscape, which consists of a number of strategic prospects that fit our acquisition criteria. In July we acquired two generic products - Ursodiol tablets and Lamotrigine orally disintegrating tablets - as part of our strategy to expand our product offerings.”

 

“As previously announced, the FDA completed their inspections at both our Taiwan and Hayward facilities, both of which resulted in Form 483’s being issued. We are preparing responses for the FDA, while continuing to advance our quality improvement initiatives.”

 

“We continue to analyze our internal generic and brand pipelines to identify opportunities for improvement that will drive growth and will communicate our progress as these plans are finalized.”

 

 
1

 

 

Business Segment Information

 

The Company has two reportable segments, the Global Pharmaceuticals Division (generic products and services) and the Impax Pharmaceuticals 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.

 

Global Pharmaceuticals Division Information

   

Three Months Ended

   

Six Months Ended

 

(unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Revenues:

                               

Global Product sales, net

  $ 163,961     $ 89,758     $ 270,078     $ 187,563  

Rx Partner

    9,204       3,668       11,639       6,781  

Other revenues

    3,229       539       3,817       1,258  

Total revenues

    176,394       93,965       285,534       195,602  

Cost of revenues

    69,872       54,727       126,894       116,171  

Gross profit

    106,522       39,238       158,640       79,431  

Operating expenses:

                               

Research and development

    10,745       9,291       21,962       21,002  

Patent litigation expense

    1,767       4,304       3,940       8,582  

Selling, general and administrative

    4,572       3,882       6,955       8,926  

Total operating expenses

    17,084       17,477       32,857       38,510  

Income from operations

  $ 89,438     $ 21,761     $ 125,783     $ 40,921  
                                 

Gross margin

    60.4 %     41.8 %     55.6 %     40.6 %

Adjusted gross profit (1)

  $ 117,219     $ 46,641     $ 183,108     $ 102,235  

Adjusted gross margin (1)

    66.5 %     49.6 %     64.1 %     52.3 %

 

(1) 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.

 

 

Global Product sales, net increased 82.7% to $164.0 million in the second quarter 2014, compared to $89.8 million in the prior year period. The increase was driven by higher sales of several key generic products, including the mid-April launch of the Company’s allotment of a specified number of bottles of authorized generic RENVELA®.

 

Rx Partner revenues increased $5.5 million to $9.2 million in the second quarter 2014, compared to $3.7 million in the prior year period. The increase was the result of profit share earned of $3.3 million under the Company’s agreement with Perrigo Company, plc related to the launch of generic Astepro®, as well as higher profit share earned under the Company’s agreement with Teva Pharmaceutical Industries, Limited of $2.2 million.

 

Gross margin in the second quarter 2014 increased to 60.4%, compared to gross margin of 41.8% in the prior year period. Adjusted gross margin in the second quarter 2014 increased to 66.5%, compared to adjusted gross margin of 49.6% in the prior year period. The increase in gross margin and adjusted gross margin was due to the favorable contribution from several key generic products, including authorized generic RENVELA®.

 

 
2

 

 

Total Global Pharmaceuticals operating expenses in the second quarter 2014 decreased to $17.1 million, compared to $17.5 million in the prior year period, due to reduced patent litigation expenses.

 

 

Impax Pharmaceuticals Division Information

   

Three Months Ended

   

Six Months Ended

 

(unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Revenues:

                               

Impax Product sales, net

  $ 11,460     $ 35,334     $ 20,769     $ 81,855  

Other revenues

    267       332       536       663  

Total revenues

    11,727       35,666       21,305       82,518  

Cost of revenues

    8,477       16,017       12,551       45,190  

Gross profit

    3,250       19,649       8,754       37,328  

Operating expenses:

                               

Research and development

    10,507       6,249       21,031       14,143  

Selling, general and administrative

    11,734       11,836       20,955       24,599  

Total operating expenses

    22,241       18,085       41,986       38,742  

(Loss) income from operations

  $ (18,991 )   $ 1,564     $ (33,232 )   $ (1,414 )
                                 

Gross margin

    27.7 %     55.1 %     41.1 %     45.2 %

Adjusted gross profit (1)

  $ 3,980     $ 25,444     $ 10,214     $ 54,852  

Adjusted gross margin (1)

    33.9 %     71.3 %     47.9 %     66.5 %

 

(1) 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.

 

 

Impax Product sales, net decreased 67.6% to $11.5 million in the second quarter 2014, compared to $35.3 million in the prior year period, due to lower sales of Zomig® tablet and orally disintegrating tablet products from the loss of exclusivity in May 2013, partially offset by higher sales of Zomig nasal spray which has patents expiring as late as May 2021.

 

Gross margin in the second quarter 2014 decreased to 27.7%, compared to 55.1% in the prior year period, due to an increase in inventory reserves. Adjusted gross margin in the second quarter 2014 decreased to 33.9%, compared to adjusted gross margin of 71.3% in the prior year period, primarily due to an increase in inventory reserves.

 

Total Impax Pharmaceuticals operating expenses in the second quarter 2014 increased to $22.2 million, compared to $18.1 million in the prior year period, due to an increase in research and development activity.

 

 
3

 

 

Corporate and Other

   

Three Months Ended

   

Six Months Ended

 

(unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

General and administrative expenses

  $ 16,511     $ 17,557     $ 30,384     $ 29,468  

Loss from operations

  $ (16,511 )   $ (17,557 )   $ (30,384 )   $ (29,468 )

 

General and administrative expenses in the second quarter 2014 decreased to $16.5 million, compared to $17.6 million in the prior year period. The decrease is primarily due to employee severance costs of $5.4 million included in the second quarter 2013, for which there was no comparable amount in the current year period. Excluding the severance charges, adjusted general and administrative expenses in the second quarter 2014 increased $4.3 million, compared to the prior year period due to the inclusion of executive management transitional expenses, and higher expenses for incentive compensation and litigation.

 

 

2014 Financial Guidance

 

Impax Laboratories full year 2014 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 updated its estimated adjusted 2014 financial guidance as noted below.

 

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

Total research and development (R&D) expenses across the generic and brand divisions of approximately $82.0 million to $88.0 million; generic R&D expenses of approximately $46.0 million to $49.0 million and brand R&D expenses of approximately $36.0 million to $39.0 million.

Patent litigation expenses of approximately $11.0 million to $13.0 million.

Selling, general and administrative expenses of approximately $115.0 million to $120.0 million.

Capital expenditures of approximately $40.0 million to $45.0 million.

Hayward facility remediation costs of approximately $25.0 million to $30.0 million.

Effective tax rate of approximately 32% to 34% on a GAAP basis, which assumes that the U.S. R&D tax credit is renewed for 2014. The R&D tax credit expired on December 31, 2013. 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 on August 6, 2014 at 8:30 a.m. ET to discuss its results. The call 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 67408949. 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).

 

 
4

 

 

About Impax Laboratories, Inc.

 

Impax Laboratories, Inc. (Impax) is a technology based 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 Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals 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.

 

"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 impact of consolidation of the Company’s customer base; the impact of competition; the substantial portion of our total revenues derived from sales of a limited number of products; 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; the Company’s inexperience in conducting clinical trials and submitting new drug applications; 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 our industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure; 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 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; the restrictions imposed by the Company’s credit facility; 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.

 

 
5

 

  

Company Contact:

Mark Donohue

Investor Relations and Corporate Communications

(215) 558-4526          

www.impaxlabs.com 

 

 
6

 

 

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,

 
   

2014

   

2013

   

2014

   

2013

 

Revenues:

                               

Global Pharmaceuticals Division, net

  $ 176,394     $ 93,965     $ 285,534     $ 195,602  

Impax Pharmaceuticals Division, net

    11,727       35,666       21,305       82,518  

Total revenues

    188,121       129,631       306,839       278,120  

Cost of revenues

    78,349       70,744       139,445       161,361  

Gross profit

    109,772       58,887       167,394       116,759  

Operating expenses:

                               

Research and development

    21,252       15,540       42,993       35,145  

Patent litigation expense

    1,767       4,304       3,940       8,582  

Selling, general and administrative

    32,817       33,275       58,294       62,993  

Total operating expenses

    55,836       53,119       105,227       106,720  

Income from operations

    53,936       5,768       62,167       10,039  

Other income, net

    31       2,997       107       152,453  

Interest income

    365       315       753       591  

Interest expense

    93       (45 )     28       (328 )

Income before income taxes

    54,425       9,035       63,055       162,755  

Provision for income taxes

    19,354       3,416       21,559       51,694  

Net income

  $ 35,071     $ 5,619     $ 41,496     $ 111,061  
                                 

Net income per share:

                               

Basic

  $ 0.52     $ 0.08     $ 0.61     $ 1.67  

Diluted

  $ 0.50     $ 0.08     $ 0.59     $ 1.62  
                                 

Weighted average common shares outstanding:

                               

Basic

    68,095,159       66,748,864       67,899,894       66,618,889  

Diluted

    70,313,491       68,287,948       70,195,329       68,382,004  

 

 
7

 

 

Impax Laboratories, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

 

   

June 30,

   

December 31,

 
   

2014

   

2013

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 159,139     $ 184,612  

Short-term investments

    253,888       228,521  

Accounts receivable, net

    163,896       112,993  

Inventory, net

    84,796       70,107  

Deferred income taxes

    50,844       50,788  

Prepaid expenses and other assets

    6,985       12,721  

Total current assets

    719,548       659,742  

Property, plant and equipment, net

    194,076       188,191  

Other assets

    94,593       91,746  

Intangible assets, net

    22,770       29,670  

Goodwill

    27,574       27,574  

Total assets

  $ 1,058,561     $ 996,923  
                 

Liabilities and Stockholders' Equity

               

Current liabilities:

               

Accounts payable and accrued expenses

  $ 140,853     $ 138,347  

Accrued profit sharing and royalty expenses

    13,079       11,560  

Deferred revenue

    2,417       3,983  

Total current liabilities

    156,349       153,890  

Deferred revenue

    3,733       4,267  

Other liabilities

    29,738       28,563  

Total liabilities

    189,820       186,720  

Total stockholders' equity

    868,741       810,203  

Total liabilities and stockholders' equity

  $ 1,058,561     $ 996,923  

 

 

 

 
8

 

 

Impax Laboratories, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited, amounts in thousands)

   

Six Months Ended

 
   

June 30,

 
   

2014

   

2013

 

Cash flows from operating activities:

               

Net income

  $ 41,496     $ 111,061  

Adjustments to reconcile net income to net cash provided by operating activities:

               

Depreciation and amortization

    16,303       24,179  

Provision for inventory reserves

    10,320       22,536  

Intangible asset impairment charges

    2,876       -  

Charge for licensing agreement

    2,000       -  

Accretion of interest income on short-term investments

    (421 )     (335 )

Deferred income tax benefit

    (4,786 )     (6,873 )

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

    (1,507 )     (446 )

Recognition of deferred revenue

    (2,100 )     (2,226 )

Accrued profit sharing and royalty expense

    23,582       38,011  

Payments of profit sharing and royalty expense

    (22,063 )     (27,392 )

Share-based compensation expense

    9,520       10,503  

Changes in assets and liabilities which (used) provided cash

    (62,800 )     126  

Net cash provided by operating activities

    12,420       169,144  

Cash flows from investing activities:

               

Purchase of short-term investments

    (235,388 )     (220,284 )

Maturities of short-term investments

    210,442       147,948  

Purchases of property, plant and equipment

    (18,271 )     (20,075 )

Payments for licensing agreements

    (3,000 )     -  

Net cash used in investing activities

    (46,217 )     (92,411 )

Cash flows from financing activities:

               

Proceeds from exercise of stock options and ESPP

    7,660       4,351  

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

    1,507       446  

Net cash provided by financing activities

    9,167       4,797  

Effect of exchange rate changes on cash and cash equivalents

    (843 )     (709 )

Net (decrease) increase in cash and cash equivalents

    (25,473 )     80,821  

Cash and cash equivalents, beginning of period

    184,612       142,162  

Cash and cash equivalents, end of period

  $ 159,139     $ 222,983  

 

 
9

 

 

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 income, GAAP net income 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 inclusion 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 income to adjusted net income.

   

Three months ended

   

Six months ended

 

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

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Net income

  $ 35,071     $ 5,619     $ 41,496     $ 111,061  

Adjusted to add (deduct):

                               

Amortization and acquisition-related costs (a)

    2,594       6,225       5,024       13,367  

Hayward facility remediation costs (b)

    8,651       4,562       17,168       6,498  

Employee severance (c)

    182       7,988       860       7,988  

Payments received from litigation settlement (d)

    -       (3,000 )     -       (153,049 )

Intangible asset impairment charges (e)

    -       -       2,876       -  

Provision for inventory reserve (f)

    -       -       -       18,053  

R&D partner milestone payment (g)

    -       -       -       2,000  

Loss on asset disposal (h)

    -       -       -       881  

Payment for licensing agreement (i)

    -       -       2,000       -  

Income tax effect

    (4,204 )     (5,476 )     (10,649 )     34,401  

Adjusted net income

  $ 42,294     $ 15,918     $ 58,775     $ 41,200  
                                 

Adjusted net income per diluted share

  $ 0.60     $ 0.23     $ 0.84     $ 0.60  

Net income per diluted share

  $ 0.50     $ 0.08     $ 0.59     $ 1.62  

 

(a)

Resulting from the second quarter 2014 payment to Perrigo Company in conjunction with the Company’s at risk launch of generic Astepro®, the June 2012 agreement with TOLMAR, Inc., (Tolmar) and the January 2012 agreement with AstraZeneca. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(b)

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

 

 
10

 

 

(c)

The three months and six months ended June 30, 2014 expenses are included in “Cost of revenues” on the Consolidated Statements of Operations. Refer to the “Non-GAAP Financial Measures” tables for the allocation of the prior year amounts on the Consolidated Statement of Operations.

(d)

Reflects the receipt of a pre-tax payment of $102.0 million from Endo Health Solutions Inc. in connection with a settlement and license agreement and $48.0 million from Shire LLC (Shire) in connection with the settlement of litigation relating to supply of authorized generic Adderall XR® products to the Company. Included in “Other income, net” on the Consolidated Statements of Operations.

(e)

In June 2012, the Company entered into an agreement with Tolmar which granted to the Company an exclusive license to commercialize up to 11 generic topical prescription drug products, including nine then currently approved products and two products then pending approval at the FDA, in the United States and its territories. During the first quarter 2014, as a result of a decline in pricing on a currently approved product, the Company revised the projections for the Tolmar 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 for the Global Pharmaceuticals Division.

(f)

An inventory reserve charge relating to discontinued products, a reserve of pre-launch inventory for RYTARYTM and other generic products as a result of the delay in the anticipated regulatory approvals. Included in “Cost of revenues” on the Consolidated Statements of Operations.

(g)

The Company recorded a $2.0 million milestone payment in the first quarter of 2013 under the terms of a research and development partnership agreement. Included in “Research and development” expense on the Consolidated Statements of Operations.

(h)

Included in “Other income, net” on the Consolidated Statements of Operations.

(i)

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.

 

 
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Impax Laboratories, Inc.

Non-GAAP Financial Measures

 

The following table reconciles reported net income to adjusted EBITDA.

   

Three months ended

   

Six months ended

 

(Unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Net income

  $ 35,071     $ 5,619     $ 41,496     $ 111,061  

Adjusted to add (deduct):

                               

Interest income

    (365 )     (315 )     (753 )     (591 )

Interest expense

    (93 )     45       (28 )     328  

Depreciation and other

    5,694       5,556       11,279       10,812  

Income taxes

    19,354       3,416       21,559       51,694  

EBITDA

    59,661       14,321       73,553       173,304  
                                 

Adjusted to add (deduct):

                               

Amortization and acquisition-related costs

    2,594       6,225       5,024       13,367  

Hayward facility remediation costs

    8,651       4,562       17,168       6,498  

Employee severance

    182       7,988       860       7,988  

Payments received from litigation settlement

    -       (3,000 )     -       (153,049 )

Intangible asset impairment charges

    -       -       2,876       -  

Provision for inventory reserve

    -       -       -       18,053  

R&D partner milestone payment

    -       -       -       2,000  

Loss on asset disposal

    -       -       -       881  

Payment for licensing agreement

    -       -       2,000       -  

Share-based compensation

    5,134       6,144       9,520       10,503  

Adjusted EBITDA

  $ 76,222     $ 36,240     $ 111,001     $ 79,545  

 

 
12

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

 

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

 

(Unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Cost of revenues

  $ 78,349     $ 70,744     $ 139,445     $ 161,361  

Adjusted to deduct:

                               

Amortization and acquisition-related costs

    2,594       6,225       5,024       13,367  

Hayward facility remediation costs

    8,651       4,562       17,168       6,498  

Employee severance

    182       2,411       860       2,411  

Intangible asset impairment charge

    -       -       2,876       -  

Provision for inventory reserve

    -       -       -       18,053  

Adjusted cost of revenues

  $ 66,922     $ 57,546     $ 113,517     $ 121,032  
                                 

Adjusted gross profit (1)

  $ 121,199     $ 72,085     $ 193,322     $ 157,088  

Adjusted gross margin (1)

    64.4 %     55.6 %     63.0 %     56.5 %
                                 

Research and development expenses

  $ 21,252     $ 15,540     $ 42,993     $ 35,145  

Adjusted to deduct:

                               

Payment for licensing agreement (2)

    -       -       2,000       -  

Employee severance (3)

    -       91       -       91  

R&D partner milestone payment (3)

    -       -       -       2,000  

Adjusted research and development expenses

  $ 21,252     $ 15,449     $ 40,993     $ 33,054  
                                 

Selling, general and administrative expenses

  $ 32,817     $ 33,275     $ 58,294     $ 62,993  

Adjusted to deduct:

                               

Employee severance (4)

    -       5,486       -       5,486  

Adjusted selling, general and administrative expenses

  $ 32,817     $ 27,789     $ 58,294     $ 57,507  

 

(1)

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.

(2)

Included within the Impax Pharmaceuticals Division reported results.

(3)

Included within the Global Pharmaceuticals Division reported results.

(4)

Included within Corporate and Other general and administrative expenses.

 

 
13

 

 

Impax Laboratories, Inc.

Non-GAAP Financial Measures

 

The following tables reconcile the Global Pharmaceuticals Division and the Impax Pharmaceuticals Division reported cost of revenues to adjusted cost of revenues, adjusted gross profit and adjusted gross margin.

 

Global Pharmaceuticals Division Information

   

Three months ended

   

Six months ended

 

(unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Cost of revenues

  $ 69,872     $ 54,727     $ 126,894     $ 116,171  

Adjusted to deduct:

                               

Amortization and acquisition-related costs

    1,864       430       3,564       859  

Hayward facility remediation costs

    8,651       4,562       17,168       6,498  

Employee severance

    182       2,411       860       2,411  

Provision for inventory reserve

    -       -       -       13,036  

Intangible asset impairment charge

    -       -       2,876       -  

Adjusted cost of revenues

  $ 59,175     $ 47,324     $ 102,426     $ 93,367  
                                 

Adjusted gross profit (1)

  $ 117,219     $ 46,641     $ 183,108     $ 102,235  

Adjusted gross margin (1)

    66.5 %     49.6 %     64.1 %     52.3 %

 

Impax Pharmaceuticals Division Information

   

Three months ended

   

Six Months Ended

 

(unaudited, amounts in thousands)

 

June 30,

   

June 30,

 
   

2014

   

2013

   

2014

   

2013

 

Cost of revenues

  $ 8,477     $ 16,017     $ 12,551     $ 45,190  

Adjusted to deduct:

                               

Amortization and acquisition-related costs

    730       5,795       1,460       12,507  

Provision for inventory reserve

    -       -       -       5,017  

Adjusted cost of revenues

  $ 7,747     $ 10,222     $ 11,091     $ 27,666  
                                 

Adjusted gross profit (1)

  $ 3,980     $ 25,444     $ 10,214     $ 54,852  

Adjusted gross margin (1)

    33.9 %     71.3 %     47.9 %     66.5 %

 

(1)

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.

 

 

 14