Attached files

file filename
8-K - FORM 8-K - ENDO HEALTH SOLUTIONS INC.d305049d8k.htm
EX-99.2 - CERTAIN SUPPLEMENTAL INFORMATION NOT INCLUDED IN THE PRESS RELEASE - ENDO HEALTH SOLUTIONS INC.d305049dex992.htm

Exhibit 99.1

 

LOGO

CONTACT:

 

Investors/Media       Media
Blaine Davis       KevinWiggins
(610) 459-7158       (610) 459-7281
Investors      
Jonathan Neely      
(610) 459-6645      

ENDO PHARMACEUTICALS REPORTS STRONG FOURTH QUARTER FINANCIAL RESULTS; PROVIDES 2012 FINANCIAL GUIDANCE

 

   

Total quarterly revenues of $803 million increase 57 percent versus prior year; branded pharmaceuticals revenues grow 16 percent, reflecting strong performance of OPANA® ER, Voltaren® Gel and LIDODERM®; Generics revenues grow 23 percent on a pro forma basis

 

   

Reported quarterly diluted EPS of $0.30 versus $0.77 for prior year

 

   

Adjusted diluted EPS of $1.40 reflecting growth of 32 percent from 2010

 

   

Reported annual diluted EPS of $1.55, down 30 percent from prior year; adjusted diluted EPS of $4.69, reflecting growth of 35 percent from 2010

 

   

Company issues 2012 guidance for revenue of $3.15 to $3.30 billion and adjusted diluted EPS of $5.00 to $5.20; expects reported or GAAP diluted EPS of $2.60 to $2.80

CHADDS FORD, Pa., Feb. 24, 2012— Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the fourth quarter of 2011.

Total revenues during the fourth quarter of 2011 increased 57 percent to $803.4 million, compared with $511.2 million in the same quarter of 2010. Net income for the three months ended Dec. 31, 2011, was $36.6 million, compared with $93.0 million in the comparable 2010 period.

Additionally, adjusted net income for the three months ended Dec. 31, 2011, was $168.2 million, up 32 percent, compared with $127.6 million in the same period in 2010. Reported diluted earnings per share for the quarter ended Dec. 31, 2011, were $0.30

 

1


compared with $0.77 reported in the fourth quarter of 2010. Adjusted diluted earnings per share for the same period were $1.40, up 32 percent from $1.06 reported in 2010.

“Endo has built a diversified platform of healthcare businesses that span branded pharmaceuticals, generics, medical devices and services, and our 2011 financial performance reinforces the execution of our growth strategy and evolution through acquisition, as well as the organic contributions and strengths of each of our business segments,” said Dave Holveck, president and CEO of Endo. “We look forward to updating our investors on the sustainable growth story of our diversified business and how we are exploring new ways to deliver integrated solutions that create value for key constituencies.”

FINANCIAL PERFORMANCE AT A GLANCE

 

($ in thousands, except per share amounts)  
     4th Quarter            Twelve Months Ended
December 31
        
     2011      2010      Change     2011      2010      Change  

Total Revenues

   $ 803,406       $ 511,190         57   $ 2,730,121       $ 1,716,229         59

Reported Net Income

     36,594         92,985         (61 )%      187,613         259,006         (28 )% 

Reported Diluted EPS

     0.30         0.77         (61 )%      1.55         2.20         (30 )% 

Adjusted Net Income

     168,186         127,641         32     568,153         410,361         38

Adjusted Diluted EPS

   $ 1.40       $ 1.06         32   $ 4.69       $ 3.48         35

BRANDED PHARMACEUTICALS

Branded pharmaceutical sales of $458 million for the fourth quarter 2011 represented an increase of 16 percent versus the prior year. The fourth quarter performance of OPANA ER, Voltaren Gel and LIDODERM contributed to a strong full year for Endo’s branded pharmaceuticals segment, which grew 13 percent versus 2010. In the fourth quarter, OPANA ER net sales grew 46 percent on prescription growth of 40 percent. Voltaren Gel net sales grew 23 percent on prescription growth of 34 percent. Net sales of LIDODERM grew 12 percent on flat prescription growth. The increase in LIDODERM net sales reflects changes as of mid November 2011, with respect to royalty obligations

 

2


among Endo, Hind Healthcare, Inc., and Teikoku Seiyaku Co., Ltd.; changes which have been previously described in our filings with the U.S. Securities and Exchange Commission.

On Dec. 12, 2011, we announced the receipt of U.S. Food and Drug Administration (FDA) approval of our new formulation of OPANA ER designed to be crush-resistant. The approval represents a significant milestone for Endo’s branded pharmaceuticals portfolio. Endo believes that this new formulation of OPANA ER, coupled with our long-term commitment to awareness and education around the appropriate use of opioids, will benefit patients, physicians and payers. Additionally, a new patent was issued during the 4th quarter, (U.S. patent number 8,075,872) covering the new formulation of OPANA ER and is expected to provide protection until November 2023 for the new formulation of Opana ER.

On Jan. 6, 2012, Endo announced the signing of a worldwide license and development agreement with U.S.-based BioDelivery Sciences International for BEMA® Buprenorphine. The addition of BEMA Buprenorphine reflects Endo’s continued commitment to its Branded Pharmaceuticals pain franchise and will broaden Endo’s portfolio of therapeutics, allowing it to offer an integrated suite of products that currently include OPANA ER, Voltaren Gel and LIDODERM, as well as a broad range of generic pain products.

GENERICS

Generics sales of $151 million for the fourth quarter 2011 represented an increase of 131 percent over last year, reflecting Endo’s acquisition of Qualitest Pharmaceuticals in November 2010. For the twelve months ended December 31, 2011, generic sales increased approximately $420 million, an increase of 287 percent, driven by the acquisition of Qualitest Pharmaceuticals. On a pro forma basis, generics sales grew 21 percent in 2011, reflecting the ability to capitalize on new business opportunities in generic pharmaceuticals.

 

3


DEVICES

Devices sales, driven by the June 2011 acquisition of American Medical Systems (AMS), were $142 million for the fourth quarter. Men’s Health, led by sales of the AMS 800® Artificial Urinary Sphincter, grew 7 percent on a pro forma basis in the fourth quarter of 2011, compared with same period last year. Benign prostatic hyperplasia (BPH), led by the increasing share of procedural volumes for the GreenLight XPS™ console and the accompanying MoXy fiber, grew 1 percent on a pro forma basis in the fourth quarter of 2011. Women’s Health continued to experience pressure in the fourth quarter of 2011, following a September FDA Advisory Committee meeting, which met to discuss the use of surgical mesh products in the repair of pelvic organ prolapse and stress urinary incontinence.

SERVICES

Services sales of $52 million for the fourth quarter 2011 represented an increase of 2 percent over last year, as a result of improved access to equipment for patients and physicians. The company expects improved top-line growth from the Services segment in 2012 and beyond from an expanding set of partnerships in our Endocare® cryoablation therapy as well as our pilot programs involving the sales of this device through the AMS channel. In the fourth quarter of 2011, HealthTronics Inc., completed the strategic acquisitions of Intuitive Medical Software (IMS) and meridianEMR, Inc., two providers of electronic medical records for urologists, that provide access to approximately 1,850 urologists using data platforms that will enhance service offerings in urology practice management.

Balance Sheet Update

During the fourth quarter of 2011, Endo made payments of approximately $140 million to reduce the outstanding principal of term-loan debt associated with the acquisition of AMS. For the full year ending Dec. 31, 2011, Endo made payments of approximately $290 million to reduce the outstanding principal of term-loan debt associated with the acquisition of AMS. At Dec. 31, 2011, the company’s debt to adjusted EBITDA ratio is

 

4


3.0 times. The company believes that it will achieve its objective of reducing its debt to adjusted EBITDA ratio to 2.0 to 2.5 times in 2013.

 

5


2012 FINANCIAL GUIDANCE

Endo’s estimates are based on projected results for the twelve months ended Dec. 31, 2012. The company’s guidance for reported (GAAP) earnings per share does not include any estimates for the potential future changes in the fair value of contingent consideration, certain separation benefits, asset impairment charges or for potential new corporate development transactions. For the full year ended Dec. 31, 2012, Endo estimates:

 

   

Total revenue between $3.15 billion and $3.30 billion

 

   

Total Branded Pharmaceuticals segment revenue between $1.740 billion and $1.800 billion

 

   

Total Generics segment revenue between $635 million and $675 million

 

   

Total Devices segment revenue between $530 million and $570 million

 

   

Total Services segment revenue between $240 million and $260 million

 

   

Reported (GAAP) diluted earnings per share between $2.60 and $2.80

 

   

Adjusted diluted earnings per share between $5.00 and $5.20

 

   

Cash flow from operations between $750 million and $850 million

 

   

Capital expenditures to be approximately $100 million

Endo’s 2012 guidance is based on certain current assumptions including:

 

   

Adjusted gross margin between 68 percent and 69 percent

 

   

Adjusted effective tax rate of between 30.5 percent and 31.5 percent

 

   

Weighted average number of common shares outstanding of 122 million shares for the year ended Dec. 31, 2012

 

   

Manufacturing of the new formulation of Opana ER to be at commercial scale by early Q2

 

   

Manufacturing of Voltaren Gel to an alternate Novartis location with product returning to market in limited capacity in early Q2, and returning to full capacity by end of Q2

 

   

Continued pressure in our AMS female surgical mesh business as a result of 2011 FDA Advisory Committee meeting

 

   

Strong business performance from our branded business portfolio of products and from Generics

 

6


Conference Call Information

Endo will conduct a conference call with financial analysts to discuss this news release today at 8:30 a.m. ET. Investors and other interested parties may call 800-561-2718 (domestic) or +1 617-614-3525 (international) and enter passcode 29896529. Please dial in 10 minutes prior to the scheduled start time.

A replay of the call will be available from Feb. 24 at 10:30 p.m. ET until 12:00 p.m. ET on Mar. 9, 2012 by dialing 888-286-8010 (domestic) or +1 617-801-6888 (international) and entering passcode 35294180.

A simultaneous webcast of the call can be accessed by visiting www.endo.com. In addition, a replay of the webcast will be available until 12:00 p.m. ET on Mar. 9, 2012. The replay can be accessed by clicking on “Events” in the Investor Relations section of the website.

 

7


Supplemental Financial Information

The following tables provide a reconciliation of our reported (GAAP) statements of operations to our adjusted statements of operations for each of the three months ended Dec. 31, 2011 and Dec. 31, 2010 (in thousands, except per share data):

 

Three Months Ended December 31, 2011 (unaudited)    Actual
Reported

(GAAP)
    Adjustments     Adjusted  

REVENUES

   $ 803,406      $ —        $ 803,406   

COSTS AND EXPENSES:

      

Cost of revenues

     294,781        (61,449 )(1)      233,332   

Selling, general and administrative

     242,656        (17,225 )(2)      225,431   

Research and development

     55,432        (752 )(3)      54,680   

Asset impairment charges

     93,398        (93,398 )(4)      —     

Acquisition-related items, net

     4,121        (4,121 )(5)      —     
  

 

 

   

 

 

   

 

 

 

OPERATING INCOME

   $ 113,018      $ 176,945      $ 289,963   
  

 

 

   

 

 

   

 

 

 

INTEREST EXPENSE, NET

     50,882        (4,938 )(6)      45,944   

LOSS ON EXTINGUISHMENT OF DEBT, NET

     3,371        (3,371 )(7)      —     

OTHER INCOME, NET

     (491     —          (491
  

 

 

   

 

 

   

 

 

 

INCOME BEFORE INCOME TAX

   $ 59,256      $ 185,254      $ 244,510   
  

 

 

   

 

 

   

 

 

 

INCOME TAX

     9,343        53,662 (8)      63,005   
  

 

 

   

 

 

   

 

 

 

CONSOLIDATED NET INCOME

   $ 49,913      $ 131,592      $ 181,505   
  

 

 

   

 

 

   

 

 

 

Less: Net income attributable to noncontrolling interests

     (13,319     —          (13,319
  

 

 

   

 

 

   

 

 

 

NET INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

   $ 36,594      $ 131,592      $ 168,186   
  

 

 

   

 

 

   

 

 

 

DILUTED EARNINGS PER SHARE

   $ 0.30        $ 1.40   

DILUTED WEIGHTED AVERAGE SHARES

     120,418          120,418   

Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

 

(1) To exclude amortization of commercial intangible assets related to marketed products of $51,925, the impact of inventory step-up recorded as part of acquisition accounting of $8,720, and certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company’s operations of $804.
(2) To exclude certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company’s operations of $3,419, amortization of customer relationships of $2,543 and the accrual of an unfavorable court decision and attorneys’ fees in the matter of Allmed Systems Inc. d/b/a Lisa Laser USA, Inc. and Lisa Laser Products OHG. vs. HealthTronics, Inc. of $11,263, which is currently pending appeal.
(3) To exclude milestone payments to partners.
(4) To exclude asset impairment charges.
(5) To exclude acquisition-related costs of $4,026 and a loss of $95 recorded to reflect the change in fair value of the contingent consideration associated with the Qualitest acquisition.
(6) To exclude additional interest expense as a result of adopting ASC 470-20.
(7) To exclude the unamortized debt issuance costs written off and recorded as a loss on extinguishment of debt upon our 2011 prepayments on our Term Loan indebtedness.
(8) To reflect the cash tax savings results from our recent acquisitions and the tax effect of the pre-tax adjustments above at applicable tax rates.

 

8


Three Months Ended December 31, 2010 (unaudited)    Actual
Reported

(GAAP)
    Adjustments     Adjusted  

REVENUES

   $ 511,190      $ —        $ 511,190   

COSTS AND EXPENSES:

      

Cost of revenues

     169,548        (35,119 )(1)      134,429   

Selling, general and administrative

     143,203        (675 )(2)      142,528   

Research and development

     39,256        (4,650 )(3)      34,606   

Asset impairment charges

     22,000        (22,000 )(4)      —     

Acquisition-related items, net

     (12,339     12,339 (5)      —     
  

 

 

   

 

 

   

 

 

 

OPERATING INCOME

   $ 149,522      $ 50,105      $ 199,627   
  

 

 

   

 

 

   

 

 

 

INTEREST EXPENSE, NET

     13,834        (4,476 )(6)      9,358   

OTHER INCOME, NET

     (1,454     —          (1,454
  

 

 

   

 

 

   

 

 

 

INCOME BEFORE INCOME TAX

   $ 137,142      $ 54,581      $ 191,723   
  

 

 

   

 

 

   

 

 

 

INCOME TAX

     31,409        19,925 (7)      51,334   
  

 

 

   

 

 

   

 

 

 

CONSOLIDATED NET INCOME

   $ 105,733      $ 34,656      $ 140,389   
  

 

 

   

 

 

   

 

 

 

Less: Net income attributable to noncontrolling interests

     (12,748     —          (12,748
  

 

 

   

 

 

   

 

 

 

NET INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

   $ 92,985      $ 34,656      $ 127,641   
  

 

 

   

 

 

   

 

 

 

DILUTED EARNINGS PER SHARE

   $ 0.77        $ 1.06   

DILUTED WEIGHTED AVERAGE SHARES

     120,516          120,516   

Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

 

(1) To exclude amortization of commercial intangible assets related to marketed products of $30,244 and the impact of inventory step-up recorded as part of acquisition accounting of $4,875.
(2) To exclude certain costs and separation benefits incurred in connection with continued efforts to enhance the Company’s operations.
(3) To exclude milestone and upfront payments to partners.
(4) To exclude asset impairment charges.
(5) To exclude acquisition-related costs of $41,231 as well as the impact, under purchasing accounting, of a gain recorded to reflect the change in the company’s current estimate of fair value, in accordance with GAAP, of the contingent consideration associated with the Indevus acquisition of ($53,570).
(6) To exclude additional interest expense as a result of adopting ASC 470-20 of $4,508 and to exclude amortization of the premium on debt acquired from Indevus of ($32).
(7) To reflect the cash tax savings resulting from the Indevus, HealthTronics, Penwest and Qualitest acquisitions and the tax effect of the pre-tax adjustments above at applicable tax rates.

 

9


The following tables provide a reconciliation of our reported (GAAP) statements of operations to our adjusted statements of operations for each of the twelve months ended Dec. 31, 2011 and Dec.31, 2010 (in thousands, except per share data):

 

Twelve Months Ended December 31, 2011(unaudited)    Actual
Reported

(GAAP)
    Adjustments     Adjusted  

REVENUES

   $ 2,730,121      $ —        $ 2,730,121   

COSTS AND EXPENSES:

      

Cost of revenues

     1,065,208        (245,089 )(1)      820,119   

Selling, general and administrative

     824,534        (37,402 )(2)      787,132   

Research and development

     182,286        (19,098 )(3)      163,188   

Asset impairment charges

     116,089        (116,089 )(4)      —     

Acquisition-related items, net

     33,638        (33,638 )(5)      —     
  

 

 

   

 

 

   

 

 

 

OPERATING INCOME

   $ 508,366      $ 451,316      $ 959,682   
  

 

 

   

 

 

   

 

 

 

INTEREST EXPENSE, NET

     148,024        (18,952 )(6)      129,072   

LOSS ON EXTINGUISHMENT OF DEBT, NET

     11,919        (11,919 )(7)      —     

OTHER INCOME, NET

     (3,268     2,636 (8)      (632
  

 

 

   

 

 

   

 

 

 

INCOME BEFORE INCOME TAX

   $ 351,691      $ 479,551      $ 831,242   
  

 

 

   

 

 

   

 

 

 

INCOME TAX

     109,626        99,011 (9)      208,637   
  

 

 

   

 

 

   

 

 

 

CONSOLIDATED NET INCOME

   $ 242,065      $ 380,540      $ 622,605   
  

 

 

   

 

 

   

 

 

 

Less: Net income attributable to noncontrolling interests

     (54,452     —          (54,452
  

 

 

   

 

 

   

 

 

 

NET INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

   $ 187,613      $ 380,540      $ 568,153   
  

 

 

   

 

 

   

 

 

 

DILUTED EARNINGS PER SHARE

   $ 1.55        $ 4.69   

DILUTED WEIGHTED AVERAGE SHARES

     121,178          121,178   

Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

 

(1) To exclude amortization of commercial intangible assets related to marketed products of $184,496, the impact of inventory step-up recorded as part of acquisition accounting of $49,438, certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company’s operations of $2,155 and milestone payments to partners of $9,000.
(2) To exclude certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company’s operations of $19,666, amortization of customer relationships of $6,473 and the accrual of an unfavorable court decision and attorneys’ fees in the matter of Allmed Systems Inc. d/b/a Lisa Laser USA, Inc. and Lisa Laser Products OHG. vs. HealthTronics, Inc. of $11,263, which is currently pending appeal.
(3) To exclude milestone payments to partners.
(4) To exclude asset impairment charges.
(5) To exclude acquisition-related costs of $41,001 and a gain of $(7,363) recorded to reflect the change in fair value of the contingent consideration associated with the Indevus and Qualitest acquisitions.
(6) To exclude additional interest expense as a result of adopting ASC 470-20.
(7) To exclude the unamortized debt issuance costs written off and recorded as a loss on extinguishment of debt of $8,548 upon the early termination of our 2010 Credit Facility and $3,371 upon our 2011 prepayments on our Term Loan indebtedness.
(8) To exclude a gain on hedging activities for foreign currencies.
(9) To reflect the cash tax savings results from our recent acquisitions and the tax effect of the pre-tax adjustments above at applicable tax rates.

 

10


Twelve Months Ended December 31, 2010 (unaudited)    Actual
Reported

(GAAP)
    Adjustments     Adjusted  

REVENUES

   $ 1,716,229      $ —        $ 1,716,229   

COSTS AND EXPENSES:

      

Cost of revenues

     504,757        (90,263 )(1)      414,494   

Selling, general and administrative

     547,605        (16,733 )(2)      530,872   

Research and development

     144,525        (24,362 )(3)      120,163   

Asset impairment charges

     35,000        (35,000 )(4)      —     

Acquisition-related items, net

     18,976        (18,976 )(5)      —     
  

 

 

   

 

 

   

 

 

 

OPERATING INCOME

   $ 465,366      $ 185,334      $ 650,700   
  

 

 

   

 

 

   

 

 

 

INTEREST EXPENSE, NET

     46,601        (16,983 )(6)      29,618   

OTHER INCOME, NET

     (1,933     (239 )(7)      (2,172
  

 

 

   

 

 

   

 

 

 

INCOME BEFORE INCOME TAX

   $ 420,698      $ 202,556      $ 623,254   
  

 

 

   

 

 

   

 

 

 

INCOME TAX

     133,678        51,201 (8)      184,879   
  

 

 

   

 

 

   

 

 

 

CONSOLIDATED NET INCOME

   $ 287,020      $ 151,355      $ 438,375   
  

 

 

   

 

 

   

 

 

 

Less: Net income attributable to noncontrolling interests

     (28,014     —          (28,014
  

 

 

   

 

 

   

 

 

 

NET INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

   $ 259,006      $ 151,355      $ 410,361   
  

 

 

   

 

 

   

 

 

 

DILUTED EARNINGS PER SHARE

   $ 2.20        $ 3.48   

DILUTED WEIGHTED AVERAGE SHARES

     117,951          117,951   

Notes to reconciliation of our GAAP statements of operations to our adjusted statements of operations:

 

(1) To exclude amortization of commercial intangible assets related to marketed products of $83,974 and the impact of inventory step-up recorded as part of acquisition accounting of $6,289.
(2) To exclude certain costs incurred with connection with continued efforts to enhance the Company’s operations.
(3) To exclude a milestone-like payment and milestone and upfront payments to partners of $23,850 and certain costs incurred in connection with continued efforts to enhance the cost structure of the company of $512.
(4) To exclude asset impairment charges.
(5) To exclude acquisition-related costs of $70,396 as well as the impact, under purchase accounting, of a gain recorded to reflect the change in the company’s current estimate of fair value, in accordance with GAAP, of the contingent consideration associated with the Indevus acquisition of ($51,420).
(6) To exclude additional interest expense as a result of adopting ASC 470-20 of $17,296 and to exclude amortization of the premium on debt acquired from Indevus of ($313).
(7) To exclude changes in fair value of financial instruments, net.
(8) To reflect the cash tax savings resulting from the Indevus, HealthTronics, Penwest and Qualitest acquisitions and the tax effect of the pre-tax adjustments above at applicable tax rates.

See Endo’s Current Report on Form 8-K filed today with the Securities and Exchange Commission for additional non-GAAP reconciliations and for an explanation of Endo’s reasons for using non-GAAP measures.

 

11


Reconciliation of Projected GAAP Diluted Earnings Per Share to Adjusted Diluted

Earnings Per Share Guidance for 2012

 

     Year Ending
December 31, 2012
 

Projected GAAP diluted income per common share

   $ 2.60      To    $ 2.80   

Upfront and milestone-related payments to partners

   $ 0.76         $ 0.76   

Amortization of commercial intangible assets and inventory step-up

   $ 1.89         $ 1.89   

Acquisition and integration costs related to recent acquisitions.

   $ 0.10         $ 0.10   

Interest expense adjustment for ASC 470-20 and other treasury related items

   $ 0.21         $ 0.21   

Tax effect of pre-tax adjustments at the applicable tax rates and certain other expected cash tax savings as a result of recent acquisitions

   ($ 0.56      ($ 0.56

Diluted adjusted income per common share guidance

   $ 5.00      To    $ 5.20   

The company’s guidance is being issued based on certain assumptions including:

 

   

Certain of the above amounts are based on estimates and there can be no assurance that Endo will achieve these results.

 

   

Includes all completed business development transactions as of February 24, 2012.

About Endo

Endo Pharmaceuticals Holdings is a U.S.-based, specialty healthcare solutions company with a diversified business model, operating in three key business segments - branded pharmaceuticals, generics and devices and services. We deliver an innovative suite of complementary products and services to meet the needs of patients in areas such as pain management, pelvic health, urology, endocrinology and oncology. For more information about Endo Pharmaceuticals Holdings and its businesses Endo Pharmaceuticals Inc., American Medical Systems, HealthTronics and Qualitest Pharmaceuticals, please visit http://www.endo.com/.

 

12


(Tables Attached)

The following tables present Endo’s unaudited Net Revenues for the three and twelve months ended Dec.31, 2011 and 2010:

Endo Pharmaceuticals Holdings Inc.

Net Revenues (unaudited)

(in thousands)

 

     Three Months Ended
December 31
    Twelve Months Ended
December 31
 
     2011      2010      Percent
Growth
    2011      2010      Percent
Growth
 

Branded Pharmaceuticals

                

LIDODERM®

   $ 232,252       $ 207,649         12   $ 825,181       $ 782,609         5

OPANA® ER

     109,118         74,734         46     384,339         239,864         60

Voltaren® Gel

     38,488         31,309         23     142,701         104,941         36

PERCOCET®

     21,835         30,919         (29 )%      104,600         121,347         (14 )% 

FROVA®

     15,994         15,401         4     58,180         59,299         (2 )% 

SUPPRELIN® LA

     13,683         13,096         4     50,115         46,910         7

VANTAS®

     8,366         4,001         109     18,978         16,990         12

VALSTAR®

     5,301         4,756         11     21,521         14,120         52

FORTESTA® Gel

     5,401         —           NM        14,869         —           NM   

Other Branded Products1

     4,224         10,071         (58 )%      21,751         68,599         (68 )% 

Royalty and Other Revenue

     3,813         3,274         16     15,532         12,893         20
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Branded Pharmaceuticals

   $ 458,475       $ 395,210         16   $ 1,657,767       $ 1,467,572         13

Total Generics

   $ 151,423       $ 65,522         131   $ 566,854       $ 146,513         287

Devices

                

Men’s Health

   $ 69,520       $ —           NM      $ 145,836       $ —           NM   

Women’s Health

     39,482         —           NM        85,509         —           NM   

BPH Therapy

     32,966         —           NM        68,954         —           NM   
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Devices

   $ 141,968       $ —           NM      $ 300,299       $ —           NM   

Total Services

   $ 51,540       $ 50,458         2   $ 205,201       $ 102,144         101
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Revenue

   $ 803,406       $ 511,190         57   $ 2,730,121       $ 1,716,229         59
  

 

 

    

 

 

      

 

 

    

 

 

    

 

1 

To conform to current year presentation, net sales from our immediate-release formulation of OPANA have been reclassified and are now included within other branded product results.

 

13


The following table presents Endo’s unaudited Pro forma Net Revenues for the eight quarters ended Dec. 31, 2011 giving effect to the AMS acquisition, the Qualitest acquisition, the Penwest acquisition and the HealthTronics, Inc. acquisition as if they had occurred on Jan. 1, 2010 :

Endo Pharmaceuticals Holdings Inc.

Net Pro Forma Revenues (unaudited)

(in thousands)

 

     2010      2011         
     Q1      Q2      Q3      Q4      Q1     Q2      Q3      Q4  

Branded Pharmaceuticals

                      

LIDODERM®

   $ 182,607       $ 196,090       $ 196,263       $ 207,649       $ 189,725      $ 195,840       $ 207,364       $ 232,252   

OPANA® ER

     49,766         56,555         58,809         74,734         84,615        92,853         97,753         109,118   

Voltaren® Gel

     20,362         26,323         26,947         31,309         31,298        36,655         36,260         38,488   

PERCOCET®

     28,673         31,805         29,950         30,919         26,960        27,675         28,130         21,835   

FROVA®

     15,082         14,680         14,136         15,401         13,208        14,163         14,815         15,994   

SUPPRELIN® LA

     10,587         12,209         11,018         13,096         11,222        12,515         12,695         13,683   

VANTAS®

     4,389         4,960         3,640         4,001         3,545        2,054         5,013         8,366   

VALSTAR®

     3,750         4,016         1,598         4,756         4,801        5,124         6,295         5,301   

FORTESTA® Gel

     —           —           —           —           (969     2,028         8,409         5,401   

Other Branded Products1

     19,257         19,799         19,472         10,071         6,970        5,609         4,948         4,224   

Royalty and Other Revenue

     5,911         3,647         4,101         3,325         4,221        3,751         3,829         3,813   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total Branded Pharmaceuticals

   $ 340,384       $ 370,084       $ 365,934       $ 395,261       $ 375,596      $ 398,267       $ 425,511       $ 458,475   

Total Generics

   $ 105,809       $ 112,075       $ 126,663       $ 122,791       $ 134,409      $ 133,047       $ 147,975       $ 151,423   

Devices

                      

Men’s Health

   $ 64,480       $ 61,361       $ 55,177       $ 65,221       $ 67,407      $ 47,790       $ 66,548       $ 69,520   

Women’s Health

     42,748         44,491         41,192         48,816         45,325        46,689         38,240         39,482   

BPH Therapy

     25,911         29,176         26,890         32,615         28,054        29,784         26,731         32,966   

Uterine Health2

     1,787         1,340         770         341         —          —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total Devices

   $ 134,926       $ 136,368       $ 124,029       $ 146,993       $ 140,786      $ 124,263       $ 131,519       $ 141,968   

Total Services3

   $ 48,389       $ 50,300       $ 51,686       $ 50,458       $ 50,103      $ 49,485       $ 54,073       $ 51,540   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total Revenue

   $ 629,508       $ 668,827       $ 668,312       $ 715,503       $ 700,894      $ 705,062       $ 759,078       $ 803,406   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

 

1 

To conform to current year presentation, net sales from our immediate-release formulation of Opana have been reclassified and are now included within other branded product results.

2 

The uterine health product line, Her Option® was sold to a third party in February 2010. Revenues for 2010 consist of end-customer revenue earned prior to the date of sale, in addition to revenue earned as part of the product supply agreement with CooperSurgical, Inc., which continued through the fourth quarter of 2010.

3 

The services segment does not include the pro forma impact of pre-acquisition revenues from the recently acquired electronic medical records providers, Intuitive Medical Software (IMS) and meridianEMR, Inc.

 

14


The following table presents unaudited condensed consolidated Balance Sheet data at Dec. 31, 2011 and Dec. 31, 2010:

 

     December 31,
2011
     December 31,
2010
 

ASSETS

     

CURRENT ASSETS:

     

Cash and cash equivalents

   $ 547,620       $ 466,214   

Accounts receivable, net

     733,222         547,807   

Inventories, net

     262,419         178,805   

Other assets

     244,835         166,708   
  

 

 

    

 

 

 

Total current assets

   $ 1,788,096       $ 1,359,534   

PROPERTY, PLANT AND EQUIPMENT, NET

     297,731         215,295   

GOODWILL

     2,558,041         715,005   

OTHER INTANGIBLES, NET

     2,504,124         1,531,760   

OTHER ASSETS

     144,591         90,795   
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 7,292,583       $ 3,912,389   
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

CURRENT LIABILITIES:

     

Accounts payable and accrued expenses

   $ 993,216       $ 710,835   

Other current liabilities

     128,562         24,993   
  

 

 

    

 

 

 

Total current liabilities

   $ 1,121,778       $ 735,828   

DEFERRED INCOME TAXES

     617,677         217,334   

LONG-TERM DEBT, LESS CURRENT PORTION, NET

     3,424,329         1,045,801   

OTHER LIABILITIES

     89,208         110,097   

STOCKHOLDERS’ EQUITY:

     

Total Endo Pharmaceuticals Holdings Inc. stockholders’ equity

   $ 1,977,690       $ 1,741,591   

Noncontrolling interests

     61,901         61,738   
  

 

 

    

 

 

 

Total stockholders’ equity

   $ 2,039,591       $ 1,803,329   
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 7,292,583       $ 3,912,389   
  

 

 

    

 

 

 

 

15


The following table presents unaudited condensed consolidated statement of cash flow data for the twelve months ended Dec. 31, 2011 and 2010:

 

     2011     2010  

OPERATING ACTIVITIES:

    

Consolidated net income

   $ 242,065      $ 287,020   

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

    

Depreciation and amortization

     237,414        108,404   

Stock-based compensation

     46,013        22,909   

Amortization of debt issuance costs and premium / discount

     32,788        22,013   

Asset impairment charges

     116,089        35,000   

Other

     (71,835     (65,372

Changes in assets and liabilities which provided cash:

     99,581        43,672   
  

 

 

   

 

 

 

Net cash provided by operating activities

     702,115        453,646   
  

 

 

   

 

 

 

INVESTING ACTIVITIES:

    

Purchases of property, plant and equipment, net

     (59,383     (19,891

Proceeds from investments and sales of trading securities

     85,025        231,125   

Acquisition, net of cash acquired

     (2,393,397     (1,105,040

Other

     (6,337     (2,517
  

 

 

   

 

 

 

Net cash used in investing activities

     (2,374,092     (896,323
  

 

 

   

 

 

 

FINANCING ACTIVITIES:

    

Proceeds from debt, net of principal payments

     1,891,584        279,955   

Deferred financing fees

     (82,504     (13,563

Purchase of common stock

     (34,702     (58,974

Distributions to noncontrolling interests

     (53,997     (28,870

Other

     32,300        21,881   
  

 

 

   

 

 

 

Net cash provided by financing activities

     1,752,681        200,429   
  

 

 

   

 

 

 

Effect of foreign exchange rate

     702        —     

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     81,406        (242,248

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

     466,214        708,462   
  

 

 

   

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

   $ 547,620      $ 466,214   
  

 

 

   

 

 

 

 

16


Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption “Risk Factors” in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

#####

 

17