Endo Reports First Quarter Financial Results And Announces Return To Steady Supply Of Opana ER And Voltaren Gel

CHADDS FORD, Pa., May 1, 2012 /PRNewswire via COMTEX/ --

 

Total quarterly revenues of $691 million, increased 23 percent versus prior year; Driven by full quarter addition of AMS as well as Qualitest revenue growth of 8 percent.

Adjusted diluted EPS of $0.87, aligned with prior guidance of below $0.90.

Reported quarterly diluted loss per share of $0.75 versus earnings per share of $0.46 for prior year.

Management expects return to year-over-year adjusted diluted earnings growth for remainder of 2012.

OPANA ER and Voltaren Gel now in steady supply; Resolving temporary supply disruption announced in early January.

 

Endo (Nasdaq: ENDP) today reported financial results for the first quarter of 2012.

Total revenues during the first quarter of 2012 increased 23 percent to $691 million, compared with $560 million in the same quarter of 2011, reflecting organic growth and the acquisition of AMS. Endo incurred a net loss for the three months ended Mar. 31, 2012 of $87 million or $0.75 reported diluted loss per share, compared with net income of $56 million reported in the comparable 2011 period or $0.46 reported diluted earnings per share. The 2012 net loss was primarily driven by a one-time charge related to a first quarter 2012 accrual stemming from a 2010 litigation settlement with Impax Laboratories Inc. (Impax). Additionally, adjusted net income for the three months ended March 31, 2012, was $106 million, down 12 percent, compared with $120 million in the same period in 2011. Adjusted diluted earnings per share for first quarter 2012 were $0.87, down 13 percent from $1.00 reported in 2011.

"I'm extremely proud of the response by the organization in resolving the challenging, but temporary, constraints to supplies of some of our key pharmaceutical products," said Dave Holveck, president and CEO of Endo. "We are keenly focused on execution that creates the opportunity for us to continue to grow our products and services and execute our long-term vision of providing our customers with innovative healthcare solutions."

Reported diluted loss per share includes the impact of a pre-tax charge in the amount of $110 million for the period to reflect a one-time payment that the company now expects to make to Impax per the terms of Endo's 2010 settlement and license agreement with Impax. The company recognized a liability under this agreement upon successfully demonstrating, in response to the Novartis supply disruption, the ability to accelerate the manufacture and sale of the new formulation of OPANA ER, which occurred in March 2012.

 

 


 

1st Quarter


 


 

2012

2011

Change

Total Revenues

$690,633

$560,026

23%

Reported Net (Loss) Income

(87,345)

55,787

NM

Reported Diluted (Loss) Income per share

(0.75)

0.46

NM

Adjusted Net Income

106,300

120,178

(12)%

Adjusted Diluted EPS

$0.87

$1.00

(13)%

OPANA ER AND VOLTAREN GEL SUPPLY UPDATE

Endo also announced that it has now returned to steady supply of the new formulation of OPANA ER (oxymorphone HCL) designed to be crush-resistant and Voltaren Gel (diclofenac sodium topical gel) 1%. The company believes there is adequate product available for all appropriate patients, both existing and new starts, following a short-term supply disruption announced in early January.

"We are pleased to have these two important products back in steady supply across the country," said Julie McHugh, chief operating officer at Endo. "Endo's top priority is the health, well-being, and the continuity of care for our patients. Now that there is better accessibility to OPANA ER and Voltaren Gel, physicians should feel confident in prescribing these products for all appropriate patients."

 

 

Branded pharmaceutical sales of $364 million for the first quarter 2012 represented a decrease of 3 percent versus the prior year. In the first quarter, OPANA ER net sales declined 4 percent and the company did not have any sales of Voltaren Gel. As the company announced on Jan. 9, 2012, supplies of certain products including OPANA ER and Voltaren Gel were affected by the temporary closure of a Novartis-owned facility in Lincoln, Neb. Endo expects our return to normal supply conditions and return to promotional activities to facilitate a return to growth for OPANA ER and Voltaren Gel for the remainder of 2012.

Net sales of LIDODERM® grew 11 percent on flat prescription growth. The increase in LIDODERM net sales reflects changes as of mid-November 2011, with respect to royalty obligations among Endo, Hind Healthcare, Inc., and Teikoku Seiyaku Co., Ltd.; changes that have been previously described in our filings with the U.S. Securities and Exchange Commission.

During first quarter of 2012, Endo announced that it filed an amendment to its Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) calling on FDA to publicly address numerous concerns raised about approval requirements for generic versions of LIDODERM (lidocaine patch 5%). The amended CP highlights the growing scientific and regulatory support for requiring generic manufacturers to conduct comparative clinical endpoint studies to demonstrate bioequivalence to locally acting topical products like LIDODERM. The amended CP also raises several new issues that need to be resolved before FDA approves a generic formulation of LIDODERM.

Additional background information about LIDODERM and Endo's amended CP can be found at: www.endo.com/investors/overview

During first quarter of 2012, Endo announced the acquisition and issuance of additional intellectual property that will protect key commercial and developmental products within the branded pharmaceuticals segment.

On March 22, 2012, Endo announced the acquisition of U.S. patent 7,851,482 B2 for oxymorphone hydrochloride, the key active pharmaceutical ingredient in all formulations of OPANA, from Johnson Matthey plc. Johnson Matthey is a leading supplier of active pharmaceutical ingredients through its worldwide Fine Chemicals Division. The patent, now listed by Endo in the FDA's Orange Book, extends patent protection for its OPANA franchise, through 2029.

On April 3, 2012, the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent 8,147,866 to BioDelivery Sciences International (BDSI) that extends the exclusivity of the BioErodible MucoAdhesive (BEMA) drug delivery technology for BEMA Buprenorphine, a developmental product licensed previously by Endo, from 2020 to 2027.

 

 

Generic product sales of $145 million for the first quarter 2012 represented an increase of 8 percent over last year. Qualitest expects strong net sales growth for the remainder of 2012 driven by strong demand for its commercial products. Qualitest remains focused on process improvements and increased efficiencies in order to enhance manufacturing capacity.

 

 

Devices sales, driven by the June 2011 acquisition of American Medical Systems (AMS), were $130 million for the first quarter. Men's Health, led by sales of the AMS 800® Artificial Urinary Sphincter, were flat on a pro forma basis in the first quarter of 2012, compared with same period last year. Benign prostatic hyperplasia (BPH), led by the increasing share of procedural volumes for the GreenLight XPS(TM) console and the accompanying MoXy fiber, grew 3 percent on a pro forma basis in the first quarter of 2012. Women's Health sales declined 25 percent on a pro forma basis in the first quarter of 2012, compared with same period last year. Net sales declines in Women's Health were driven by year-over-year declines in procedural volumes. Procedural volumes stabilized sequentially in Women's Health as physician and patient education activities continue to improve understanding of the safety profiles for the company's effective surgical mesh therapy offerings.

 

 

Services sales of $52 million for the first quarter 2012 represented an increase of 3 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 the recent addition of an electronic medical records offering that is focused on practices specializing in urology, 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.

 

 

Endo now expects for full year 2012:

 

Reported (GAAP) diluted earnings per share between $1.75 and $1.95

 

Endo reiterated full year 2012 financial guidance as follows:

 

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

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

 

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.

 

 

During the first quarter of 2012, Endo made payments of approximately $219 million to reduce the outstanding principal of term-loan debt associated with the acquisition of AMS. 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.

 

 

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 866-510-0710 (domestic) or +1 617-597-5378 (international) and enter passcode 71552059. Please dial in 10 minutes prior to the scheduled start time.

A replay of the call will be available from May 1 at 10:30 p.m. ET until 12:00 p.m. ET on May 15, 2012 by dialing 888-286-8010 (domestic) or +1 617-801-6888 (international) and entering passcode 17794666.

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 May 15, 2012. The replay can be accessed by clicking on "Events" in the Investor Relations section of the website.

 

 

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 March 31, 2012 and March 31, 2011 (in thousands, except per share data):

Three Months Ended March 31, 2012 (unaudited)

Actual

Reported

(GAAP)

Adjustments


 

Adjusted

REVENUES

$ 690,633

$ --


 

$ 690,633


 


 


 


 


 

COSTS AND EXPENSES:


 


 


 


 

Cost of revenues

364,820

(161,238)

(1)

203,582

Selling, general and administrative

254,454

(13,867)

(2)

240,587

Research and development

88,688

(46,972)

(3)

41,716

Asset impairment charges

40,000

(40,000)

(4)

--

Acquisition-related items, net

3,749

(3,749)

(5)

--


 


 


 


 


 

OPERATING (LOSS) INCOME

$ (61,078 )

$ 265,826


 

$ 204,748


 


 


 


 


 

INTEREST EXPENSE, NET

46,896

(4,976)

(6)

41,920

LOSS ON EXTINGUISHMENT OF DEBT, NET

5,426

(5,426)

(7)

--

OTHER EXPENSE, NET

451

--


 

451


 


 


 


 


 

(LOSS) INCOME BEFORE INCOME TAX

$ (113,851 )

$ 276,228


 

$ 162,377


 


 


 


 


 

INCOME TAX

(39,326 )

82,583

(8)

43,257


 


 


 


 


 

CONSOLIDATED NET (LOSS) INCOME

$ (74,525 )

$ 193,645


 

$ 119,120


 


 


 


 


 

Less: Net income attributable to noncontrolling interests

(12,820 )

--


 

(12,820)


 


 


 


 


 

NET (LOSS) INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

$ (87,345)

$ 193,645


 

$ 106,300


 


 


 


 


 


 


 


 


 


 

DILUTED (LOSS) EARNINGS PER SHARE

$ (0.75)


 


 

$ 0.87

DILUTED WEIGHTED AVERAGE SHARES

117,052


 


 

122,591

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 $50,603, the impact of inventory step-up recorded as part of acquisition accounting of $1,262, the accrual for the payment to Impax related to sales of OPANA ER of $110,000, milestone payments and receipts of $(1,131) and certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company's operations of $504.

(2) To exclude certain integration costs and separation benefits incurred in connection with continued efforts to enhance the company's operations of $11,110 and amortization of customer relationships of $2,757.

(3) To exclude milestone payments to partners.

(4) To exclude asset impairment charges.

(5) To exclude acquisition-related costs of $3,876 and a gain of $(127) 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 2012 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.

Three Months Ended March 31, 2011 (unaudited)

Actual

Reported

(GAAP)

Adjustments


 

Adjusted

REVENUES

$ 560,026

$ --


 

$ 560,026


 


 


 


 


 

COSTS AND EXPENSES:


 


 


 


 

Cost of revenues

231,558

(50,997)

(1)

180,561

Selling, general and administrative

159,386

(3,462)

(2)

155,924

Research and development

42,130

(11,001)

(3)

31,129

Acquisition-related items, net

6,073

(6,073)

(4)

--


 


 


 


 


 

OPERATING INCOME

$ 120,879

$ 71,533


 

$ 192,412


 


 


 


 


 

INTEREST EXPENSE, NET

18,790

(4,541)

(5)

14,249

OTHER EXPENSE, NET

348

--


 

348


 


 


 


 


 

INCOME BEFORE INCOME TAX

$ 101,741

$ 76,074


 

$ 177,815


 


 


 


 


 

INCOME TAX

33,446

11,683

(6)

45,129


 


 


 


 


 

CONSOLIDATED NET INCOME

$ 68,295

$ 64,391


 

$ 132,686


 


 


 


 


 

Less: Net income attributable to noncontrolling interests

(12,508)

--


 

(12,508)


 


 


 


 


 

NET INCOME ATTRIBUTABLE TO ENDO PHARMACEUTICALS HOLDINGS INC.

$ 55,787

$ 64,391


 

$ 120,178


 


 


 


 


 


 


 


 


 


 

DILUTED EARNINGS PER SHARE

$ 0.46


 


 

$ 1.00

DILUTED WEIGHTED AVERAGE SHARES

120,761


 


 

120,761

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 $37,211 and the impact of inventory step-up recorded as part of acquisition accounting of $13,786.

(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 acquisition-related costs of $6,758 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 and Qualitest acquisitions of $(685).

(5) To exclude additional interest expense as a result of adopting ASC 470-20.

(6) 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.

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

$1.75

To

$1.95


 

Upfront and milestone-related payments to partners

$0.71


 

$0.71


 

Amortization of commercial intangible assets and inventory step-up

$1.87


 

$1.87


 

Acquisition and integration costs related to recent acquisitions.

$0.29


 

$0.29


 

One-time payment now expected to be made to Impax Labs

$0.90


 

$0.90


 

Impairment of long-lived assets

$0.33


 

$0.33


 

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

($1.06)


 

($1.06)


 

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 May 1, 2012.

Endo Pharmaceuticals Holdings Inc. (Endo) is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.

(Tables Attached)

The following tables present Endo's unaudited Net Revenues for the three months ended March 31, 2012 and 2011:


 


 

Endo Pharmaceuticals Holdings Inc.


 


 


 

Net Revenues (unaudited)


 


 


 

(in thousands)


 


 

Posted: May 2012


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