Attached files

file filename
8-K - FORM 8-K - Impax Laboratories, LLCc20764e8vk.htm
Exhibit 99.1
(IMPAX LOGO)
Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
Impax Laboratories Reports Second Quarter 2011 Financial Results
HAYWARD, Calif. (August 2, 2011) — Impax Laboratories, Inc. (NASDAQ: IPXL) today reported second quarter ended June 30, 2011 financial results.
“Our second quarter 2011 revenues and earnings were lower than the prior year period primarily due to higher second quarter 2010 sales from the remaining exclusive period of generic Flomax®. However, our second quarter 2011 revenues improved sequentially over the first quarter 2011 revenues and exceeded our expectations,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “The sequential improvement was primarily due to the late April receipt of our supplier’s initial product shipment from 2011 quota of generic Adderall XR® which resulted in second quarter generic Adderall XR® product sales of $58.2 million, as compared to $36.1 million in the first quarter of 2011.”
Dr. Hsu continued, “We began to receive generic Adderall XR® product supply from our supplier’s 2011 quota during the quarter, although below our request for quantities sufficient to satisfy strong customer demand. The supply helped us alleviate some of the customer backorder for the product. Nonetheless, our second quarter 2011 sales of the product were still lower than the prior year period and customer demand for generic Adderall XR ® continues to exceed available supply. We continue to pursue every available means to acquire sufficient product to meet this demand. In the third quarter of 2011, assuming continued receipt of scheduled shipments, our generic Adderall XR® sales could be similar to second quarter 2011 levels, while fourth quarter expectations will depend on additional updated shipment information from our supplier in August and September 2011.”
Second Quarter 2011 Results
                                 
    Three Months Ended June 30,  
(unaudited, amounts in millions)   2011     2010     $ change     % change  
Revenues
                               
Generic and brand products and services
  $ 64.0     $ 62.3     $ 1.7       3 %
Generic Adderall XR ®
    58.2       63.3       (5.1 )     (8 %)
Generic Flomax®
    3.7       27.4       (23.7 )     (87 %)
 
                       
Total Revenues
  $ 125.9     $ 153.0     $ (27.1 )     (18 %)
 
                       
  Total revenue was $125.9 million compared to $153.0 million in the prior year period primarily due to higher second quarter 2010 sales from the remaining exclusive period of generic Flomax®, whereby the Company had contractual market exclusivity starting on March 2, 2010 and continuing for the succeeding eight week period. The entry of competing generic versions of Flomax® into the market in late April 2010 resulted in both price erosion and reduction in the Company’s market share.
  Earnings before interest, taxes, depreciation and amortization (EBITDA), excluding adjusted items, was $25.6 million compared to $54.8 million in the prior year period (generic Flomax® contributed $22.3 million to the second quarter 2010 EBITDA, excluding adjusted items).

 

 


 

  Net income, excluding adjusted items, was $15.1 million compared to $32.8 million in the prior year period (generic Flomax® contributed $14.1 million to the second quarter 2010 net income, excluding adjusted items).
  Net income per diluted share, excluding adjusted items, was $0.22 compared to $0.50 in the prior year period (generic Flomax® contributed $0.22 to the second quarter 2010 net income per diluted share, excluding adjusted items).
  Net income was $12.6 million, or $0.19 per diluted share, compared to $31.3 million, or $0.48 per diluted share in the prior year period.
Please refer to “Non-GAAP Financial Measures” below for a reconciliation of GAAP to non-GAAP items.
Dr. Hsu further stated, “We are working expeditiously to resolve the manufacturing observations raised in the warning letter to the satisfaction of the U.S. Food and Drug Administration (FDA). In late June 2011, we submitted our warning letter response and will continue to cooperate with the FDA to resolve the observations. We have already made significant manufacturing and quality control systems improvements and believe we have addressed a number of the FDA’s observations. Upon our internal completion, we will request a re-inspection of our Hayward facility by the FDA, the timing of which is wholly dependent upon the FDA’s availability. Based on our most recent estimate, we expect to incur charges of approximately $10.0 million in 2011 related to the development and implementation of manufacturing and quality control systems improvements associated with our response to the observations raised in the warning letter.”
“This current interruption has not impacted our ability to execute our long-term growth strategy. We have a significant pipeline of generic products pending at the FDA and continue to file Abbreviated New Drug Applications which we believe will create additional product launch opportunities. Regarding our brand business, we remain on schedule to file a New Drug Application for IPX066, our leading brand product candidate for Parkinson’s Disease, in the fourth quarter of 2011. We also remain active pursuing external opportunities with the potential to further drive future growth,” concluded Dr. Hsu.

 

2


 

Segment Information — Second Quarter 2011
The Company has two reportable segments, the Global Pharmaceuticals Division (generic products & services) and the Impax Pharmaceuticals Division (brand products & services) and does not allocate general corporate services to either segment.
Global Pharmaceuticals Division Information
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
(unaudited, amounts in thousands)   2011     2010     2011     2010  
Revenues:
                               
Global Product sales, net
  $ 111,125     $ 137,977     $ 203,463     $ 447,754  
RX Partner
    4,866       5,802       7,548       10,705  
OTC Partner
    1,184       2,309       3,127       4,074  
Research Partner
    3,384       3,384       9,769       6,769  
 
                       
Total Revenues
    120,559       149,472       223,907       469,302  
Cost of revenues
    63,257       65,599       110,431       142,031  
 
                       
Gross profit
    57,302       83,873       113,476       327,271  
 
                       
Operating expenses:
                               
Research and development
    13,466       10,354       23,242       19,789  
Patent litigation
    2,209       1,769       3,983       3,753  
Selling, general and administrative
    2,938       3,688       5,870       7,023  
 
                       
Total operating expenses
    18,613       15,811       33,095       30,565  
 
                       
Income from operations
  $ 38,689     $ 68,062     $ 80,381     $ 296,706  
 
                       
Global Pharmaceuticals Division revenues in the second quarter of 2011 were $120.6 million compared to $149.5 million in the prior year period, the reduction in revenues were driven by a decrease in Global Product sales, net, as discussed below.
For the second quarter of 2011, Global Product sales, net, were $111.1 million, down $26.9 million from the prior year period due to a $23.8 million decline in sales of generic Flomax® as noted above, and a $5.1 million decline in sales of authorized generic Adderall XR® products, partially offset by higher sales of our fenofibrate products. The decrease in sales of authorized generic Adderall XR® was principally the result of product supply disruptions.
Gross profit of $57.3 million represents a 48% gross margin in the second quarter of 2011, and was lower than the 56% gross margin for the prior year period primarily due to higher sales of our generic Flomax® products in the second quarter of 2010 which carried a higher average gross margin during the contractual market exclusivity period.
Total generic operating expenses of $18.6 million in the second quarter of 2011 increased $2.8 million over the prior year period primarily due to higher spending on research and development.

 

3


 

Impax Pharmaceuticals Division Information
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
(unaudited, amounts in thousands)   2011     2010     2011     2010  
Revenues:
                               
Rx Partner
  $ 1,437     $     $ 2,875     $  
Promotional Partner
    3,535       3,500       7,070       7,003  
Research Partner
    329       110       659       110  
 
                       
Total revenues
    5,301       3,610       10,604       7,113  
Cost of revenues
    2,901       3,293       5,841       6,437  
 
                       
Gross profit
    2,400       317       4,763       676  
 
                       
Operating expenses:
                               
Research and development
    10,512       10,755       20,227       19,629  
Selling, general and administrative
    1,377       738       2,483       1,547  
 
                       
Total operating expenses
    11,889       11,493       22,710       21,176  
 
                       
Loss from operations
  $ (9,489 )   $ (11,176 )   $ (17,947 )   $ (20,500 )
 
                       
Impax Pharmaceuticals Division revenues in the second quarter of 2011 increased $1.7 million to $5.3 million over the prior year period due to the addition of Rx Partner revenues.
In the second quarter of 2011, the Company recognized $1.4 million of Rx Partner revenue related to the $11.5 million up-front payment (recognized over 24 months) received under the License, Development and Commercialization Agreement with Glaxo Group Limited which was entered into in December 2010.
The loss from operations in the second quarter of 2011 is a result of the Company’s strategy to invest in research and development to develop brand products which provide longer product life cycles and the potential for significantly higher profit margins than generic products.
Corporate and Other
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
(unaudited, amounts in thousands)   2011     2010     2011     2010  
General and administrative expenses
  $ 11,194     $ 7,592     $ 23,735     $ 15,934  
 
                       
Loss from operations
  $ (11,194 )   $ (7,592 )   $ (23,735 )   $ (15,934 )
 
                       
Corporate general and administrative expenses in the second quarter of 2011 increased $3.6 million compared to the prior year period primarily due to an increase in legal fees.
Cash and short-term investments were $335.5 million as of June 30, 2011, as compared to $348.4 million as of December 31, 2010. The decline is primarily due to capital expenditures during the six month period ended June 30, 2011.

 

4


 

2011 Financial Outlook

The Company updated its full year 2011 financial outlook as noted below.
  Cash flows from operating activities, less capital expenditures (Free Cash Flow), planned to be positive.
  Gross margins as a percent of total revenues of approximately 50%.
  Total research and development expenses across the generic and brand divisions to approximate $87 million with generic R&D of approximately $47 million and brand R&D of approximately $40 million.
  Patent litigation expenses of approximately $13 million.
  Selling, general and administrative expenses of approximately $65 million.
  Updated August 2011 — Effective tax rate of approximately 34% to 36%.
  Capital expenditures to be approximately $69 million.
Conference Call Information
The Company will host a conference call today at 11:00 a.m. EDT to discuss its results. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. 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). The access conference code is 83298478.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. 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 branded products. Impax markets its generic products through its Global Pharmaceuticals Division and markets third-party branded products through the Impax Pharmaceuticals Division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. 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, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceuticals and healthcare industries, the regulatory environment, the ability to protect the Company’s intellectual property, exposure to product liability claims 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 Impax 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


 

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,  
    2011     2010     2011     2010  
Revenues:
                               
Global Pharmaceuticals Division
  $ 120,559     $ 149,472     $ 223,907     $ 469,302  
Impax Pharmaceuticals Division
    5,301       3,610       10,604       7,113  
 
                       
Total Revenues
    125,860       153,082       234,511       476,415  
 
                               
Cost of revenues
    66,158       68,892       116,272       148,468  
 
                       
Gross profit
    59,702       84,190       118,239       327,947  
 
                       
 
                               
Operating expenses:
                               
Research and development
    23,978       21,109       43,469       39,418  
Patent litigation
    2,209       1,769       3,983       3,753  
Selling, general and administrative
    15,509       12,018       32,088       24,504  
 
                       
Total operating expenses
    41,696       34,896       79,540       67,675  
 
                       
Income from operations
    18,006       49,294       38,699       260,272  
Other expense, net
    (545 )     (25 )     (540 )     (42 )
Interest income
    290       192       611       274  
Interest expense
    (11 )     (23 )     (28 )     (70 )
 
                       
Income before income taxes
    17,740       49,438       38,742       260,434  
Provision for income taxes
    5,214       18,130       12,358       97,613  
 
                       
Net income before noncontrolling interest
    12,526       31,308       26,384       162,821  
Add back loss attributable to noncontrolling interest
    24       40       29       12  
 
                       
Net Income
  $ 12,550     $ 31,348     $ 26,413     $ 162,833  
 
                       
 
                               
Net Income per share:
                               
Basic
  $ 0.20     $ 0.51     $ 0.41     $ 2.65  
 
                       
Diluted
  $ 0.19     $ 0.48     $ 0.39     $ 2.51  
 
                       
 
                               
Weighted average common shares outstanding:
                               
Basic
    64,024,483       61,876,599       63,709,258       61,444,707  
Diluted
    67,654,047       65,538,805       67,401,018       64,887,770  

 

6


 

Impax Laboratories, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
                 
    June 30,     December 31,  
    2011     2010  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 138,182     $ 91,796  
Short-term investments
    197,342       256,605  
Accounts receivable, net
    121,070       82,054  
Inventory, net
    46,038       44,549  
Deferred product manufacturing costs
    1,371       2,012  
Deferred income taxes
    40,465       39,271  
Prepaid expenses and other current assets
    10,060       4,407  
 
           
Total current assets
    554,528       520,694  
 
           
Property, plant and equipment, net
    111,413       106,280  
Deferred product manufacturing costs
    7,900       8,223  
Deferred income taxes, net
    6,470       5,069  
Other assets
    35,689       25,478  
Goodwill
    27,574       27,574  
 
           
Total assets
  $ 743,574     $ 693,318  
 
           
 
               
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 18,484     $ 18,812  
Accrued expenses
    73,048       72,788  
Accrued income taxes payable
          2,393  
Accrued profit sharing and royalty expenses
    27,818       14,147  
Deferred revenue
    23,413       18,276  
 
           
Total current liabilities
    142,763       126,416  
 
           
Deferred revenue
    27,484       44,195  
Other liabilities
    17,152       14,558  
 
           
Total liabilities
    187,399       185,169  
Total stockholders’ equity
    556,175       508,149  
 
           
Total liabilities and stockholders’ equity
  $ 743,574     $ 693,318  
 
           

 

7


 

Impax Laboratories, Inc.
Consolidated Statements of Cash Flows
(unaudited, amounts in thousands)
                 
    Six Months Ended June 30,  
    2011     2010  
Cash flows from operating activities:
               
Net income
  $ 26,413     $ 162,833  
Adjustments to reconcile net income to net cash (used in) provided by operating activities:
               
Depreciation and amortization
    8,338       6,068  
Amortization of Credit Agreement deferred financing costs
    13       25  
Accretion of interest income on short-term investments
    (461 )     (168 )
Deferred income taxes
    3,046       7,026  
Provision for uncertain tax positions
    79       24  
Tax benefit related to the exercise of employee stock options
    (5,641 )     (4,329 )
Deferred revenue
    1,887       21,764  
Deferred product manufacturing costs
    (1,061 )     (8,791 )
Recognition of deferred revenue
    (13,461 )     (21,658 )
Amortization deferred product manufacturing costs
    2,026       9,425  
Accrued profit sharing and royalty expense
    44,789       71,902  
Payments of profit sharing and royalty expense
    (31,121 )     (94,925 )
Payments of accrued litigation settlements
          (5,865 )
Share-based compensation expense
    6,133       5,234  
Bad debt expense
    125       153  
Changes in assets and liabilities:
               
Accounts receivable
    (39,141 )     49,686  
Inventory
    (1,489 )     6,554  
Prepaid expenses and other assets
    (15,389 )     (7,852 )
Accounts payable, accrued expenses and income taxes payable
    (2,815 )     29,151  
Other liabilities
    2,487       1,859  
 
           
Net cash (used in) provided by operating activities
    (15,243 )     228,116  
 
           
 
               
Cash flows from investing activities:
               
Purchase of short-term investments
    (180,274 )     (195,450 )
Maturities of short-term investments
    239,998       103,551  
Purchases of property, plant and equipment
    (14,569 )     (7,690 )
 
           
Net cash provided by (used in) investing activities
    45,155       (99,589 )
 
           
 
               
Cash flows from financing activities:
               
Tax benefit related to the exercise of employee stock options
    5,641       4,329  
Proceeds from exercise of stock options and ESPP
    10,833       12,818  
 
           
Net cash provided by financing activities
    16,474       17,147  
 
           
 
               
Net increase in cash and cash equivalents
    46,386       145,674  
Cash and cash equivalents, beginning of period
    91,796       31,770  
 
           
Cash and cash equivalents, end of period
  $ 138,182     $ 177,444  
 
           

 

8


 

Impax Laboratories, Inc.
Second Quarter 2011

Non-GAAP Financial Measures
Net income excluding adjusted items, net income per diluted share excluding adjusted items, and EBITDA excluding adjusted items, are not measures of financial performance under generally accepted accounting principles (GAAP) and should not be construed as substitutes for, or superior to, net income, and net income per diluted share 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 calculation of net income excluding adjusted items, net income per diluted share excluding adjusted items and EBITDA excluding adjusted items, 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 net income excluding adjusted items.
                                 
    Three months ended     Six months ended  
    June 30,     June 30,  
(Unaudited, in millions, except per share amounts)   2011     2010     2011     2010  
Net income
  $ 12.6     $ 31.3     $ 26.4     $ 162.8  
Adjusted to add (deduct):
                               
Share-based compensation
    3.2       2.4       6.0       5.2  
Employee severance
                0.8        
Income tax effect
    (0.7 )     (0.9 )     (1.3 )     (2.0 )
 
                       
Net income excluding adjusted items
  $ 15.1     $ 32.8     $ 32.0     $ 166.1  
 
                       
 
                               
Net income excluding adjusted items per diluted share
  $ 0.22     $ 0.50     $ 0.45     $ 2.56  
Net income per diluted share
  $ 0.19     $ 0.48     $ 0.38     $ 2.51  
The following table reconciles reported net income to EBITDA excluding adjusted items.
                                 
    Three months ended     Six months ended  
    June 30,     June 30,  
(Unaudited, amounts in millions)   2011     2010     2011     2010  
Net income
  $ 12.6     $ 31.3     $ 26.4     $ 162.8  
Adjusted to add (deduct):
                               
Interest income
    (0.3 )     (0.2 )     (0.6 )     (0.3 )
Interest expense
    0.0       0.0       0.0       0.1  
Depreciation and amortization
    4.9       3.1       8.3       6.1  
Income taxes
    5.2       18.1       12.4       97.6  
 
                       
EBITDA
    22.4       52.4       46.5       266.3  
 
                       
 
                               
Adjusted to add:
                               
Share-based compensation
    3.2       2.4       6.0       5.2  
Severance
                0.8        
 
                       
EBITDA excluding adjusted items
  $ 25.6     $ 54.8     $ 53.4     $ 271.5  
 
                       

 

9