FRAZER, Pa., Oct. 28 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today reported third quarter 2010 sales of $707.1 million, a 32 percent increase compared to sales of $535.2 million for the third quarter 2009. Basic income per common share for the quarter was $1.76. Excluding amortization expense and certain other items, basic adjusted income per common share for the quarter was $2.27, a 34 percent increase over the $1.70 for the third quarter of 2009. Adjusted net income for the third quarter of 2010 was $170.7 million, a 35 percent increase over the $126.7 million for the third quarter of 2009.
Central nervous system (CNS) franchise sales were $354.3 million during the quarter, a 19 percent increase compared to the same period last year. Pain franchise sales were $131.2 million, a 10 percent increase versus third quarter 2009. Oncology franchise sales were $132.9 million, a 60 percent increase over the same period last year due to strong sales of TREANDA® (bendamustine HCL) for Injection. Other product sales were $88.8 million, an increase of 153 percent versus third quarter of 2009 primarily due to the acquisition of Mepha in the second quarter of 2010.
"We achieved record earnings and cash flow from operations in the quarter while continuing to expand our global product offerings," said Kevin Buchi, Chief Operating Officer. "Our robust cash flow generation gives us the flexibility to invest in our rich pipeline while continuing our active business development efforts, positioning us very well for the future."
The company is updating its guidance for full year 2010. Total sales guidance is $2.69-$2.73 billion. This includes expected CNS franchise sales of $1.34-$1.37 billion, pain franchise sales of $510-$530 million, oncology franchise sales of $500-$520 million, and other product sales of $325-$345 million. Full year R&D and SG&A guidance is $430-$450 million and $910-$930 million, respectively. Adjusted net income guidance is increased to $617-$632 million and basic adjusted income per common share guidance is increased to $8.20-$8.40, assuming 75.2 million basic shares outstanding.
Cephalon is introducing full year 2011 sales guidance of $2.96-$3.04 billion. This includes CNS franchise sales of $1.39-$1.43 billion, pain franchise sales of $540-$570 million, oncology franchise sales of $570-$600 million, and other product sales of $420-$450 million. R&D and SG&A guidance for 2011 are $505-$525 million and $970 million-$1 billion, respectively.
The company also is introducing adjusted net income guidance for full year 2011 of $652-$668 million. Cephalon is introducing 2011 adjusted net income per common share guidance of $8.45-$8.65, assuming 77.2 million basic shares outstanding.
Basic adjusted income per common share guidance for both the full-year 2010 and full-year 2011 is reconciled below and is subject to the assumptions set forth therein. References in this press release to basic income per common share, basic adjusted income per common share, basic adjusted income per common share guidance, adjusted net income, adjusted net income guidance, adjusted net income per common share, adjusted net income per common share guidance refer to those metrics on an "attributable to Cephalon" basis and do not include any income or losses attributable to noncontrolling interests.
The Cephalon management will discuss the company's third quarter 2010 performance in a conference call with investors beginning at 5:00 p.m. U.S. EDT today. To participate in the conference call, dial +913-312-0678 and refer to conference code 4886405. Investors can listen to the call live by logging on to the company's website at www.cephalon.com and clicking on "Investor Information," then "Webcast." The conference call will be archived and available to investors for one week after the call.
About Cephalon, Inc.Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries.
More information on Cephalon and its products is available at http://www.cephalon.com
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; sales, adjusted net income and basic adjusted income per common share guidance for full-year 2010 and full-year 2011 and SG&A and R&D guidance for the full-year 2010 and full-year 2011; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
This press release and/or the financial results attached to this press release include "Adjusted Net Income," "Basic Adjusted Income per Common Share," "Adjusted Net Income Guidance," "Basic Adjusted Income per Common Share Guidance," and "Diluted Adjusted Income Per Common Share," amounts that are considered "non-GAAP financial measures" under SEC rules. As required, we have provided reconciliations of these measures. Additional required information is located in the Form 8-K furnished to the SEC in connection with this press release.Contacts:Media:
Investors:Candace Steele Flippin
Robert (Chip) Merritt610-727-6231
firstname.lastname@example.orgJoseph Marczely610email@example.comCEPHALON, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share data)(Unaudited)Three Months EndedNine Months EndedSeptember 30,September 30,2010200920102009REVENUES:Net sales
9,91614,18944,29528,583716,993549,4122,040,4881,617,193COSTS AND EXPENSES:Cost of sales
151,93990,456427,721293,633Research and development
110,96699,157317,604304,266Selling, general and administrative
226,791194,068689,900618,314Change in fair value of contingent consideration
2,3131,0627,6383,944Acquired in-process research and development
-6,000-46,118497,256390,7431,449,1771,266,275INCOME FROM OPERATIONS
219,737158,669591,311350,918OTHER INCOME (EXPENSE):Interest income
(24,989)(26,495)(78,895)(63,213)Other income (expense), net
(2,846)3,775(19,449)42,418(26,927)(20,899)(94,206)(17,340)INCOME BEFORE INCOME TAXES
192,810137,770497,105333,578INCOME TAX EXPENSE
131,54895,097324,278210,919NET LOSS ATTRIBUTABLE TO NONCONTROLLING INTEREST
9527,6257,85135,150NET INCOME ATTRIBUTABLE TO CEPHALON, INC.
246,069BASIC INCOME PER COMMON SHARE ATTRIBUTABLE TO CEPHALON, INC.
3.44DILUTED INCOME PER COMMON SHARE ATTRIBUTABLE TO CEPHALON, INC.
3.17WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING ATTRIBUTABLE TO CEPHALON, INC.
75,20174,64775,12871,541WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING-ASSUMING DILUTIONATTRIBUTABLE TO CEPHALON, INC.
79,77378,43180,76177,552CEPHALON, INC. AND SUBSIDIARIESReconciliation of GAAP Net Income to Adjusted Net Income Attributable to Cephalon, Inc.(Unaudited)Three Months EndedSeptember 30,20102009GAAP NET INCOME ATTRIBUTABLE TO CEPHALON, INC.
2,722Cost of sales adjustments
(1)Research and development adjustments
(2)Selling, general and administrative adjustments
(3)Change in fair value of contingent consideration adjustment
(5)In-process research and development adjustments
(6)Interest expense adjustment
(7)Other income adjustment
(8)Income tax adjustment
(9)*Noncontrolling Interest adjustments:Other revenues
-(3)Research and development
2836,295Selling, general and administrative240827Other expense
-23Less amount attributable to noncontrolling interest
(523)(7,532)38,18423,983ADJUSTED NET INCOME ATTRIBUTABLE TO CEPHALON, INC.
26,705BASIC ADJUSTED INCOME PER COMMON SHARE
.70DILUTED ADJUSTED INCOME PER COMMON SHARE
.62WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING
75,20174,647WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING-ASSUMING DILUTION
79,77378,431* Amounts recorded by our Variable Interest Entities that have been excluded from net income attributable to Cephalon, Inc.Notes to Reconciliation of GAAP Net Income to Adjusted Net Income(1) To exclude the on-going amortization of acquired intangible assets ($31.4M in 2010; $26.4M in 2009), accelerated depreciation related to restructuring ($4.2M in 2010; $5.0M in 2009), amortization of inventory revaluation related to Mepha ($5.2M in 2010), offset by the gain recognized in connection with an agreement to reduce our excess modafinil purchase commitments ($9.5M in 2009).(2) In 2010, to exclude the impairment of an investment ($2.0M). In 2009, to exclude accelerated depreciation related to restructuring ($0.3M) and charges related to payment for research and development collaboration ($1.0M).(3) In 2010, to exclude proceeds related to the settlement of litigation in Europe ($2.1M), offset by charges related to the acquisition of Mepha ($0.2M). In 2009, to exclude charges related to the acquisition of Arana Therapeutics Limited ($0.6M). (4) To exclude the change in fair value of the Ception contingent consideration.(5) To exclude costs related to restructurings.(6) To exclude charges incurred in exchange for license rights to certain of XOMA Ltd.’s proprietary antibody library materials.(7) To exclude imputed interest expense associated with convertible debt ($15.1M in 2010; $17.0M in 2009).(8) In 2009, to exclude $0.4M gain on foreign exchange of Australian Dollar acquisition funds. (9) To reflect the tax effect of pre-tax adjustments at applicable tax rates and certain other tax adjustments primarily related to changes in valuation allowances and other changes in tax assets and liabilities.CEPHALON, INC. AND SUBSIDIARIESReconciliation of GAAP Net Income to Adjusted Net Income Attributable to Cephalon, Inc.(Unaudited)Nine Months EndedSeptember 30,20102009GAAP NET INCOME ATTRIBUTABLE TO CEPHALON, INC.
246,069 Cost of sales adjustments24,225
(1)Research and development adjustments2,690
(2)Selling, general and administrative adjustments9,581
(3)Change in fair value of contingent consideration adjustment,314
(4)- Restructuring charges7,638
(5)In-process research and development adjustments- 46,118
(6)Interest expense adjustment50,072
(7)Other (income) expense adjustment,567
(8)Arana noncontrolling interest adjustments- (819)
(9)Income tax adjustment(64,293)
(10)*Noncontrolling Interest adjustments:Other revenues(31)30 Research and development ,377 25,519 Selling, general and administrative3,462 7,373 Interest income(7)(182)Interest expense54 ,299 Other expense33 Income taxes(3,848)47 Less amount attributable to noncontrolling interest(6,273)(34,119)47,794 92,428 ADJUSTED NET INCOME ATTRIBUTABLE TO CEPHALON, INC.
338,497 BASIC ADJUSTED INCOME PER COMMON SHARE
4.73 DILUTED ADJUSTED INCOME PER COMMON SHARE
4.36 WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING
75,12871,541WEIGHTED AVERAGE NUMBER OF COMMONSHARES OUTSTANDING-ASSUMING DILUTION80,761 77,552 * Amounts recorded by our Variable Interest Entities that have been excluded from net income attributable to Cephalon, Inc.Notes to Reconciliation of GAAP Net Income to Adjusted Net Income(1) To exclude the on-going amortization of acquired intangible assets ($89.4M in 2010; $70.6M in 2009), accelerated depreciation related to restructuring ($14.9M in 2010; $14.0M in 2009), amortization of inventory revaluation related to Mepha ($10.5M in 2010) and the write-off of modafinil purchase commitments in excess of estimated requirements ($9.4M in 2010; $3.0M in 2009), offset by the gain recognized in connection with an agreement to reduce our excess modafinil purchase commitments ($9.5M in 2009).(2) To exclude accelerated depreciation related to restructuring ($0.7M in 2010; $0.9M in 2009), the impairment of an investment ($2.0M in 2010), charges related to payments for several research and development collaborations ($2.0M in 2009) and charges related to our transaction with Arana Therapeutics Limited ($1.5M in 2009).(3) In 2010, to exclude charges related to the acquisition of Mepha ($10.3M), the acquisition of Ception noncontrolling interest ($1.4M), offset by proceeds related to the settlement of litigation in Europe ($2.1M). In 2009, to exclude charges related to the acquisition of Arana Therapeutics Limited ($7.8M) and charges related to our settlement with Takeda ($6.5M) to resolve our remaining contractual arrangements. (4) To exclude the change in fair value of the Ception contingent consideration.(5) To exclude costs related to restructurings.(6) In 2009, to exclude charges related to the deconsolidation of Acusphere ($9.3M), the acquisition of worldwide license rights related to LUPUZOR from ImmuPharma ($30.0M), license rights for bendamustine hydrochloride in China and Hong Kong ($0.8M) and license rights to certain of XOMA Ltd.’s proprietary antibody library materials ($6.0M).(7) To exclude imputed interest expense associated with convertible debt ($50.1M in 2010; $40.5M in 2009).(8) In 2010, to exclude the following losses related to the acquisition of Mepha AG:- $9.1M loss on foreign exchange derivative instruments; and- $2.5M loss on foreign exchange of Swiss Franc acquisition funds. In 2009, to exclude the following gains and losses related to the acquisition of Arana Therapeutics Limited:- $6.6M gain on pre-bid Arana holding; - $2.8M loss on contingent consideration (90% ownership incentive payment);- $10.0M gain on excess of net assets over consideration; - $19.0M gain on foreign exchange derivative instruments; - $5.6M gain on foreign exchange of Australian Dollar acquisition funds; and- $1.6M gain on dividend income related to our initial purchase of Arana shares. (9) To exclude the portion of non-cash charges related to our acquisition of Arana Therapeutics Limited that are reflected in (8) above but do not affect net income because they are attributed to noncontrolling interests.(10) To reflect the tax effect of pre-tax adjustments at applicable tax rates and certain other tax adjustments primarily related to; changes in valuation allowances and other changes in tax assets and liabilities.CEPHALON, INC. AND SUBSIDIARIESCONSOLIDATED SALES DETAIL(In thousands)(Unaudited)Three Months Ended%September 30,Increase20102009(Decrease)United StatesEuropeTotalUnited StatesEuropeTotalUnited StatesEuropeTotalSales:CNSProprietary CNSPROVIGIL
9,5771,02510,60211,5601,34012,900(17)(24)(18)Other Proprietary CNS
26,784-26,78426,703-26,7030-0Other Proprietary Pain
8,295-8,29519,332-19,332(57)0(57)Other Generic Pain
103,911-103,91154,532-54,53291-91Other Proprietary Oncology
535,22322%78%32%Nine Months Ended%September 30,Increase20102009(Decrease)United StatesEuropeTotalUnited StatesEuropeTotalUnited StatesEuropeTotalSales:CNSProprietary CNSPROVIGIL
28,9943,51132,50537,0583,87140,929(22)(9)(21)Other Proprietary CNS
80,467-80,46783,807-83,807(4)-(4)Other Proprietary Pain
32,609-32,60966,834-66,834(51)0(51)Other Generic Pain
284,900-284,900160,549-160,54977-77Other Proprietary Oncology
462,871$ 1,996,193$ 1,308,412$
280,198$ 1,588,61017%65%26% Europe- Primarily Europe, Middle East and Africa Proprietary products are products which are sold under patent coverage. Generic products are products sold without patent coverage in the primary sales territory. Patent coverage may exist in other territories. CEPHALON, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(In thousands, except share data)(Unaudited)September 30, December 31, 20102009CURRENT ASSETS: Cash and cash equivalents
,647,635 Receivables, net
450,614376,076 Inventory, net
295,880240,576 Deferred tax assets, net
225,031243,246 Other current assets
66,78758,423Total current assets
12,59412,427 PROPERTY AND EQUIPMENT, net
833,358590,284 INTANGIBLE ASSETS, net
1,234,181981,857 DEBT ISSUANCE COSTS
15,36218,862 OTHER ASSETS
4,658,095CURRENT LIABILITIES: Current portion of long-term debt, net
818,925 Accounts payable
100,91788,829 Accrued expenses
507,408430,209Total current liabilities
1,252,4221,337,963 LONG-TERM DEBT
384,638363,696 DEFERRED TAX LIABILITIES, net
219,091159,328 OTHER LIABILITIES
178,245207,307EQUITY:Cephalon Stockholders' Equity Common stock, $0.01 par value
784780 Additional paid-in capital
2,407,5632,534,070 Treasury stock, at cost
(216,597)(208,427) Accumulated earnings (deficit)
153,470(178,659) Accumulated other comprehensive income
164,888114,194Total Cephalon stockholders' equity
4,658,095CEPHALON, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited)Nine Months EndedSeptember 30,20102009CASH FLOWS FROM OPERATING ACTIVITIES:Net income
210,919Adjustments to reconcile net income to net cash provided by operating activities:Deferred income tax expense (benefit)
(27,976)(40,182)Depreciation and amortization
163,049136,403Stock-based compensation expense
31,74036,710Amortization of debt discount and debt issuance costs
51,31841,273Loss (gain) on foreign exchange contracts
9,499(26,754)Gain on acquisition of Arana
-(10,008)IPR&D from Acusphere deconsolidation
1,749(5,079)Changes in operating assets and liabilities:Receivables
7,48032,206Accounts payable, accrued expenses and deferred revenues
5,047(43,059)Net cash provided by operating activities
650,540517,131CASH FLOWS FROM INVESTING ACTIVITIES:Purchases of property and equipment
(34,989)(43,647)Proceeds from sale of property and equipment
4,748-Cash balance from consolidation of variable interest entity
-52,563Investment in Ception
-(75,000)Acquisition of Arana, net of cash acquired
-(232,527)Acquisition of Mepha, net of cash acquired
(549,463)-Purchases of investments
(60)(9,292)(Cash settlements of) proceeds from foreign exchange contracts
(9,499)26,754Sales and maturities of available-for-sale investments
-5,074Net cash used for investing activities
(589,263)(276,075)CASH FLOWS FROM FINANCING ACTIVITIES:Proceeds from sale of common stock
-288,000Proceeds from exercises of common stock options
15,1836,701Windfall tax benefits from stock-based compensation
-1,259Acquisition of treasury stock
(33)(29)Acquisition of Ception NCI
(299,289)-Payments on and retirements of long-term debt
(222,079)(11,246)Net proceeds from issuance of convertible subordinated notes
-484,719Proceeds from sale of warrants
-37,640Purchase of convertible note hedge
-(121,040)Net cash (used for) provided by financing activities
(506,218)686,004EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
6,2962,295NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
(438,645)929,355CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
1,647,635524,459CASH AND CASH EQUIVALENTS, END OF PERIOD
,208,990$ 1,453,814CEPHALON, INC. AND SUBSIDIARIESReconciliation of Projected GAAP Basic Income per Common Shareto Basic Adjusted Income Per Common Share Guidance(Unaudited)Twelve Months EndedTwelve Months EndedDecember 31, 2010December 31, 2011Projected GAAP basic income per common share
7.11Amortization of current intangibles
1.41Accelerated depreciation adjustment- CIMA
0.01Accelerated depreciation adjustment- Mitry-Mory
-Cost of sales adjustments
-Research and development adjustments
-Selling, general and administrative adjustments
-Change in fair value of contingent consideration adjustments
0.04Other income (expense) adjustments
-Interest expense adjustments
0.84Tax effect of pre-tax adjustments at the applicable tax rates
(0.76)Basic adjusted income per common share guidance
$8.65The company’s guidance is being issued based on certain assumptions including: - Adjusted effective tax rate of approximately 33.5% in 2010 and 33.0% in 2011; - Weighted average number of common shares outstanding of 75.2 and 77.2 million shares for the years ended December 31, 2010 and 2011, respectively; and - No generic competition for AMRIX and FENTORA in 2011.
|SOURCE Cephalon, Inc.|
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