Exhibit 99.1
Contact:
Laurie W. Little
Valeant Pharmaceuticals
949-461-6002
laurie.little@valeant.com
VALEANT PHARMACEUTICALS REPORTS
THIRD QUARTER FINANCIAL RESULTS
| • | | Revenue up 31%, 45% at constant exchange rates |
|
| • | | GAAP EPS $0.45, Cash EPS $0.58 |
|
| • | | GAAP Cash Flow from Operations $52 million; Adjusted Cash Flow from Operations $65 million |
|
| • | | Increased guidance for 2009 is Cash EPS of $2.10 — $2.20 |
|
| • | | Both NDA and MAA submissions for retigabine completed in October |
ALISO VIEJO, Calif., November 2, 2009 — Valeant Pharmaceuticals International (NYSE: VRX) today announced third quarter financial results for 2009.
“Valeant continues to perform well, generating strong earnings growth in the third quarter,” stated J. Michael Pearson, chairman and chief executive officer. “All of our businesses are growing and generating positive cash flows this quarter. In particular, I would like to note our 18% organic growth rate from total product sales, at constant currency, and our $65 million of adjusted cashflow from operations.”
Revenues:
Total revenue was $220.3 million in the third quarter of 2009 as compared to $168.4 million in the third quarter of 2008, an increase of 31%.
Product sales in the Specialty Pharmaceuticals segment were $101.6 million in the third quarter of 2009, as compared to $70.1 million in the third quarter of 2008, an increase of 45%. At constant exchange rates, Specialty Pharmaceuticals product sales increased 47%. Within the Specialty Pharmaceuticals segment, alliance and service revenue was $25.6 million in the third quarter of 2009, which included an $8.5 million profit share related to the 1% clindamycin and 5% benzoyl peroxide product (IDP-111) that was launched by Mylan in August 2009, $5.0 million related to the Dow services business, and $3.8 million of revenue from the GlaxoSmithKline (GSK) collaboration. Because the company entered into the GSK
collaboration agreement in October 2008 and acquired Dow in December 2008, no alliance or service revenue was recorded in the third quarter of 2008.
Product sales in Branded Generics — Latin America were $40.7 million in the third quarter of 2009 as compared to $42.6 million in the same period in 2008, a decrease of 5%. At constant exchange rates, product sales in Latin America in the third quarter of 2009 increased 19% as compared to the third quarter of 2008.
Product sales in Branded Generics — Europe were $40.2 million in the third quarter of 2009 as compared to $40.4 million in the same period in 2008, essentially flat. At constant exchange rates, product sales in Europe in the third quarter of 2009 increased 29% as compared to the third quarter of 2008.
Ribavirin royalties were $12.2 million in the third quarter of 2009 as compared to $15.2 million in the third quarter of 2008, a decrease of 20%. This expected decrease is entirely attributable to the expiration of royalty terms in certain European countries on the ten-year anniversary of product launches in the respective countries.
Operating Expenses/Earnings:
The company’s cost of goods sold was 29% of product sales for the third quarter of 2009 as compared to 28% in the third quarter of 2008.
Selling, general and administrative expenses decreased 6% in the third quarter of 2009 to $67.2 million as compared to $71.5 million in the third quarter of 2008, primarily attributable to the benefit of cost reduction activities and exchange rates, partially offset by increased costs attributable to acquisitions.
Research and development costs decreased 51% to $11.3 million in the third quarter of 2009 as compared to $23.2 million in the same period in 2008 primarily as a result of the company’s new leveraged R&D model.
Net interest expense increased to $12.8 million in the third quarter of 2009 as compared to $7.0 million in the third quarter of 2008, reflecting interest expense related to $365 million aggregate principal amount of senior notes issued in June 2009.
Income from continuing operations was $37.6 million for the third quarter of 2009, or $0.45 per diluted share, as compared to a loss from continuing operations of $7.3 million, or a loss of $0.08 per diluted share, for the third quarter of 2008. On a non-GAAP Cash EPS basis, adjusted income from continuing operations was $48.8 million, or $0.58 per diluted share, in the third quarter of 2009 as compared to adjusted income from continuing operations of $16.7 million, or $0.19 per diluted share, in the third quarter of 2008.
GAAP cashflow from operations for the third quarter of 2009 was $52 million, which includes the impact of ASC 470-20 (FSP APB 14-1) and acquisition transaction costs. Adjusted cashflow from operations for the third quarter of 2009 was $65 million.
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2009 Guidance:
The company is updating its previous Cash EPS target and is now targeting Cash EPS between $2.10 and $2.20 in 2009, up from prior guidance of $1.90 to $2.10.
Retigabine Update:
The company, along with its collaboration partner GSK, completed both the New Drug Application (NDA) and the Marketing Authorisation Application (MAA) submissions for retigabine on October 30, 2009.
Conference Call and Webcast Information:
Valeant will host a conference call and a live Internet webcast along with a slide presentation today at 10:00 a.m. EST (7:00 a.m. PST) to discuss its third quarter financial results for 2009. The dial-in number to participate on this call is (877) 295-5743, confirmation code 34747409. International callers should dial (973) 200-3961, confirmation code 34747409. A replay will be available approximately two hours following the conclusion of the conference call through November 16, 2009 and can be accessed by dialing (800) 642-1687, or (706) 645-9291, confirmation code 34747409. The company will webcast the conference call live over the Internet. The webcast may be accessed through the investor relations section of Valeant’s corporate Web site at www.valeant.com.
About Valeant:
Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.
Forward-looking Statements:
This press release may contain forward-looking statements, including, but not limited to, statements regarding guidance with respect to expected non-GAAP cash earnings per share. Forward-looking statements may be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company’s most recent annual or quarterly report filed with the Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements.
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Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Non-GAAP Information:
To supplement the consolidated financial results prepared in accordance with generally accepted accounting principles (GAAP), the company uses non-GAAP financial measures that exclude certain items, such as acquisition transaction fees, special charges and credits including acquired IPR&D, restructuring, asset impairments and dispositions, amortization expense, gain on early extinguishment of debt, the new non-cash accounting charge for interest on the convertible debt related to ASC 470-20 (FSP APB 14-1), which the company adopted on January 1, 2009, and the non-GAAP tax effect of such charges. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the company’s core operating results and trends for the periods presented. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. A reconciliation of GAAP to non-GAAP measures can be found in the table below. The company has provided guidance with respect to Cash Earnings Per Share, which is a non-GAAP financial measure that represents earnings per share, excluding certain items, such as acquisition transaction fees included within SG&A, special charges and credits including acquired IPR&D, restructuring, asset impairments and dispositions, amortization expense, gain on early extinguishment of debt, the new non-cash accounting charge for interest on the company’s convertible debt related to ASC 470-20 (FSP APB 14-1) and the tax effect of such charges. The company has not provided a reconciliation of these forward-looking non-GAAP financial measures due to the difficulty in forecasting and quantifying the exact amount of the items excluded from the non-GAAP financial measures that will be included in the comparable GAAP financial measures.
Financial Tables, including a reconciliation of GAAP to non-GAAP financial measures, follow.
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Table 1
Valeant Pharmaceuticals International
Statement of Income
For the Three and Nine Months Ended September 30, 2009 and 2008
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | | | | | | Nine Months Ended | | | | |
| | September 30, | | | | | | | September 30, | | | | |
(In thousands, except per share data) | | 2009 | | | 2008 | | | % Change | | | 2009 | | | 2008 | | | % Change | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Product sales | | $ | 182,529 | | | $ | 153,181 | | | | 19 | % | | $ | 502,227 | | | $ | 431,142 | | | | 16 | % |
Service revenue | | | 5,035 | | | | — | | | | NM | | | | 17,379 | | | | — | | | | NM | |
Alliance revenue (a) | | | 32,754 | | | | 15,243 | | | | 115 | % | | | 70,333 | | | | 42,821 | | | | 64 | % |
| | | | | | | | | | | | | | | | | | | | |
Total revenues | | | 220,318 | | | | 168,424 | | | | 31 | % | | | 589,939 | | | | 473,963 | | | | 24 | % |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Cost of goods sold | | | 52,295 | | | | 42,698 | | | | 22 | % | | | 134,742 | | | | 126,327 | | | | 7 | % |
Cost of services | | | 4,047 | | | | — | | | | NM | | | | 13,710 | | | | — | | | | NM | |
Selling, general and administrative (“SG&A”) | | | 67,230 | | | | 71,458 | | | | -6 | % | | | 193,981 | | | | 211,669 | | | | -8 | % |
Research and development costs, net | | | 11,296 | | | | 23,239 | | | | -51 | % | | | 29,176 | | | | 75,100 | | | | -61 | % |
Special charges and credits including acquired in-process research and development (b) | | | — | | | | — | | | | NM | | | | 1,974 | | | | — | | | | NM | |
Restructuring, asset impairments and dispositions | | | 307 | | | | 3,527 | | | | NM | | | | 3,212 | | | | 4,294 | | | | NM | |
Amortization expense | | | 17,616 | | | | 11,488 | | | | 53 | % | | | 51,725 | | | | 37,616 | | | | 38 | % |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | 152,791 | | | | 152,410 | | | | 0 | % | | | 428,520 | | | | 455,006 | | | | -6 | % |
| | | | | | | | | | | | | | | | | | | | |
Income from operations | | | 67,527 | | | | 16,014 | | | | | | | | 161,419 | | | | 18,957 | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Interest expense, net | | | (12,843 | ) | | | (6,987 | ) | | | | | | | (26,847 | ) | | | (23,736 | ) | | | | |
Gain (loss) on early extinguishment of debt | | | (155 | ) | | | (14,882 | ) | | | | | | | 7,221 | | | | (14,882 | ) | | | | |
Other expense, net including translation and exchange | | | (1,350 | ) | | | (1,556 | ) | | | | | | | (786 | ) | | | (3,389 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Income (loss) from continuing operations before income taxes | | | 53,179 | | | | (7,411 | ) | | | | | | | 141,007 | | | | (23,050 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Provision (benefit) for income taxes | | | 15,545 | | | | (148 | ) | | | | | | | 39,541 | | | | 33,726 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Income (loss) from continuing operations | | | 37,634 | | | | (7,263 | ) | | | | | | | 101,466 | | | | (56,776 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Income (loss) from discontinued operations, net | | | (354 | ) | | | 210,154 | | | | | | | | (131 | ) | | | 187,134 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Net income | | $ | 37,280 | | | $ | 202,891 | | | | | | | $ | 101,335 | | | $ | 130,358 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Earnings per share: | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Basic: | | | | | | | | | | | | | | | | | | | | | | | | |
Income (loss) from continuing operations | | $ | 0.46 | | | $ | (0.08 | ) | | | | | | $ | 1.23 | | | $ | (0.64 | ) | | | | |
Discontinued operations | | | — | | | | 2.39 | | | | | | | | — | | | | 2.10 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Basic earnings per share | | $ | 0.46 | | | $ | 2.31 | | | | | | | $ | 1.23 | | | $ | 1.46 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Shares used in per share computation | | | 81,907 | | | | 87,988 | | | | | | | | 82,407 | | | | 89,123 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Diluted: | | | | | | | | | | | | | | | | | | | | | | | | |
Income (loss) from continuing operations | | $ | 0.45 | | | $ | (0.08 | ) | | | | | | $ | 1.21 | | | $ | (0.64 | ) | | | | |
Discontinued operations | | | (0.01 | ) | | | 2.39 | | | | | | | | — | | | | 2.10 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Diluted earnings per share | | $ | 0.44 | | | $ | 2.31 | | | | | | | $ | 1.21 | | | $ | 1.46 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Shares used in per share computation | | | 83,869 | | | | 87,988 | | | | | | | | 84,040 | | | | 89,123 | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | |
(a) | | See Table 3. |
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(b) | | Special charges and credits including acquired in-process research and development for the nine months ended September 30, 2009 relates primarily to the acquisition of product rights to market Opana in Canada, Australia and New Zealand. |
Table 2
Valeant Pharmaceuticals International
Reconciliation of GAAP EPS to Cash EPS
For the Three and Nine Months Ended September 30, 2009 and 2008
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
(In thousands, except per share data) | | 2009 | | | 2008 | | | 2009 | | | 2008 | |
| | | | | | | | | | | | | | | | |
Income (loss) from continuing operations | | $ | 37,634 | | | $ | (7,263 | ) | | $ | 101,466 | | | $ | (56,776 | ) |
| | | | | | | | | | | | | | | | |
Non-GAAP adjustments(a): | | | | | | | | | | | | | | | | |
Acquisition transaction fees | | | 2,832 | | | | — | | | | 3,741 | | | | — | |
Special charges and credits including acquired in-process research and development | | | — | | | | — | | | | 1,974 | | | | — | |
Restructuring, asset impairments and dispositions | | | 307 | | | | 3,527 | | | | 3,212 | | | | 4,294 | |
Amortization expense | | | 17,616 | | | | 11,488 | | | | 51,725 | | | | 37,616 | |
| | | | | | | | | | | | |
| | | 20,755 | | | | 15,015 | | | | 60,652 | | | | 41,910 | |
ASC 470-20 (FSP APB 14-1) interest | | | 2,176 | | | | 3,797 | | | | 8,350 | | | | 11,176 | |
(Gain) loss on early extinguishment of debt | | | 155 | | | | 14,882 | | | | (7,221 | ) | | | 14,882 | |
Tax | | | (11,911 | ) | | | (9,715 | ) | | | (33,463 | ) | | | 17,376 | |
| | | | | | | | | | | | |
Total adjustments | | | 11,175 | | | | 23,979 | | | | 28,318 | | | | 85,344 | |
| | | | | | | | | | | | | | | | |
Adjusted income from continuing operations | | $ | 48,809 | | | $ | 16,716 | | | $ | 129,784 | | | $ | 28,568 | |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
GAAP earnings (loss) per share — diluted | | $ | 0.45 | | | $ | (0.08 | ) | | $ | 1.21 | | | $ | (0.64 | ) |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Cash earnings per share — diluted | | $ | 0.58 | | | $ | 0.19 | | | $ | 1.54 | | | $ | 0.32 | |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Shares used in diluted per share calculation — GAAP earnings (loss) per share | | | 83,869 | | | | 87,988 | | | | 84,040 | | | | 89,123 | |
| | | | | | | | | | | | |
| | | | | | �� | | | | | | | | | | |
Shares used in adjusted diluted per share calculation — Cash earnings per share | | | 83,869 | | | | 89,788 | | | | 84,040 | | | | 90,321 | |
| | | | | | | | | | | | |
| | |
(a) | | To supplement the financial measures prepared in accordance with generally accepted accounting principles (GAAP), the company uses non-GAAP financial measures notably cash earnings per share, organic growth and adjusted cash flow from operations that exclude certain items, such as acquisition transaction fees, special charges and credits including acquired in-process research and development, restructuring, asset impairments and dispositions, amortization expense, ASC 470-20 (FSP APB 14-1) interest, gain (loss) on early extinguishment of debt, the non-GAAP tax effect of such charges, fluctuations in exchange rates and product sales from recent acquisitions. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the company’s core operating results and trends for the periods presented. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measure |
|
| | This table includes Cash Earnings Per Share, which is a non-GAAP financial measure that represents earnings per share, excluding acquisition transaction fees included within SG&A, special charges and credits including acquired in-process research and development, restructuring, asset impairments and dispositions, amortization expense, ASC 470-20 (FSP APB 14-1) interest, gain on early extinguishment of debt and the non-GAAP tax effect of such charges. |
Table 3
Valeant Pharmaceuticals International
Statement of Revenue — by Segment
For the Three and Nine Months Ended September 30, 2009 and 2008
(In thousands)
3.1 Revenue
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
| | | | | | | | | | % | | | | | | | | | | | % | |
| | 2009 | | | 2008 | | | Change | | | 2009 | | | 2008 | | | Change | |
Specialty pharmaceuticals | | | | | | | | | | | | | | | | | | | | | | | | |
U.S. | | | | | | | | | | | | | | | | | | | | | | | | |
Dermatology (a) | | $ | 27,194 | | | $ | 17,116 | | | | 59 | % | | $ | 87,648 | | | $ | 60,109 | | | | 46 | % |
Neurology & Other | | | 48,162 | | | | 31,421 | | | | 53 | % | | | 126,014 | | | | 87,787 | | | | 44 | % |
| | | | | | | | | | | | | | | | | | | | |
Total U.S. (a) | | | 75,356 | | | | 48,537 | | | | 55 | % | | | 213,662 | | | | 147,896 | | | | 44 | % |
Canada | | | 15,831 | | | | 15,203 | | | | 4 | % | | | 46,150 | | | | 42,827 | | | | 8 | % |
Australia (a) | | | 10,429 | | | | 6,384 | | | | 63 | % | | | 24,750 | | | | 18,044 | | | | 37 | % |
| | | | | | | | | | | | | | | | | | | | |
| | | 101,616 | | | | 70,124 | | | | 45 | % | | | 284,562 | | | | 208,767 | | | | 36 | % |
Divested business | | | — | | | | — | | | | NM | | | | — | | | | 5,784 | | | | NM | |
| | | | | | | | | | | | | | | | | | | | |
Specialty pharmaceuticals product sales | | | 101,616 | | | | 70,124 | | | | 45 | % | | | 284,562 | | | | 214,551 | | | | 33 | % |
Alliance | | | 20,594 | | | | — | | | | NM | | | | 32,351 | | | | — | | | | — | |
Service | | | 5,035 | | | | — | | | | NM | | | | 17,379 | | | | — | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total specialty pharmaceuticals revenue | | | 127,245 | | | | 70,124 | | | | 81 | % | | | 334,292 | | | | 214,551 | | | | 56 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Branded generics — Latin America product sales | | | 40,679 | | | | 42,627 | | | | -5 | % | | | 108,061 | | | | 99,708 | | | | 8 | % |
Branded generics — Europe product sales(a) | | | 40,234 | | | | 40,430 | | | | 0 | % | | | 109,604 | | | | 116,883 | | | | -6 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Alliances (ribavirin royalties only) | | | 12,160 | | | | 15,243 | | | | -20 | % | | | 37,982 | | | | 42,821 | | | | -11 | % |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total revenue | | $ | 220,318 | | | $ | 168,424 | | | | 31 | % | | $ | 589,939 | | | $ | 473,963 | | | | 24 | % |
| | | | | | | | | | | | | | | | | | | | |
Total product sales included above | | $ | 182,529 | | | $ | 153,181 | | | | 19 | % | | $ | 502,227 | | | $ | 431,142 | | | | 16 | % |
3.2 Currency impact and revenue excluding currency impact(b)(c)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
| | | | | | 2009 | | | | | | | | | | | | | | | 2009 | | | | | | | | |
| | 2009 | | | excluding | | | | | | | | | | | 2009 | | | excluding | | | | | | | | |
| | currency | | | currency | | | | | | | % | | | currency | | | currency | | | | | | | % | |
| | impact | | | impact | | | 2008 | | | Change | | | impact | | | impact | | | 2008 | | | Change | |
Specialty pharmaceuticals | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
U.S. | | $ | — | | | $ | 75,356 | | | $ | 48,537 | | | | 55 | % | | $ | — | | | $ | 213,662 | | | $ | 147,896 | | | | 44 | % |
Canada | | | 1,012 | | | | 16,843 | | | | 15,203 | | | | 11 | % | | | 6,880 | | | | 53,030 | | | | 42,827 | | | | 24 | % |
Australia | | | 717 | | | | 11,146 | | | | 6,384 | | | | 75 | % | | | 4,766 | | | | 29,516 | | | | 18,044 | | | | 64 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 1,729 | | | | 103,345 | | | | 70,124 | | | | 47 | % | | | 11,646 | | | | 296,208 | | | | 208,767 | | | | 42 | % |
Divested business | | | — | | | | — | | | | — | | | | NM | | | | — | | | | — | | | | 5,784 | | | | NM | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Specialty pharmaceuticals product sales | | | 1,729 | | | | 103,345 | | | | 70,124 | | | | | | | | 11,646 | | | | 296,208 | | | | 214,551 | | | | | |
Alliance | | | — | | | | 20,594 | | | | — | | | | | | | | — | | | | 32,351 | | | | — | | | | | |
Service | | | 98 | | | | 5,133 | | | | — | | | | | | | | 635 | | | | 18,014 | | | | — | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total specialty pharmaceuticals revenue | | | 1,827 | | | | 129,072 | | | | 70,124 | | | | 84 | % | | | 12,281 | | | | 346,573 | | | | 214,551 | | | | 62 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Branded generics — Latin America product sales | | | 10,062 | | | | 50,741 | | | | 42,627 | | | | 19 | % | | | 29,468 | | | | 137,529 | | | | 99,708 | | | | 38 | % |
Branded generics — Europe product sales | | | 12,076 | | | | 52,310 | | | | 40,430 | | | | 29 | % | | | 41,037 | | | | 150,641 | | | | 116,883 | | | | 29 | % |
Alliances (ribavirin royalties only) | | | — | | | | 12,160 | | | | 15,243 | | | | -20 | % | | | — | | | | 37,982 | | | | 42,821 | | | | -11 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total revenue | | $ | 23,965 | | | $ | 244,283 | | | $ | 168,424 | | | | 45 | % | | $ | 82,786 | | | $ | 672,725 | | | $ | 473,963 | | | | 42 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Total product sales included above | | $ | 23,867 | | | $ | 206,396 | | | $ | 153,181 | | | | 35 | % | | $ | 82,151 | | | $ | 584,378 | | | $ | 431,142 | | | | 36 | % |
3.3 Alliance Revenue
| | | | | | | | | | | | | | | | | | | | |
| | | | | | Three Months Ended | | | Nine Months Ended | |
| | | | | | September 30, | | | September 30, | |
| | Segment | | | 2009 | | | 2008 | | | 2009 | | | 2008 | |
Ribavirin royalty | | Alliances | | $ | 12,160 | | | $ | 15,243 | | | $ | 37,982 | | | $ | 42,821 | |
1% clindamycin and 5% benzoyl peroxide (IDP111) profit share | | Specialty | | | 8,535 | | | | — | | | | 8,535 | | | | — | |
Other royalties | | Specialty | | | 2,281 | | | | — | | | | 7,920 | | | | — | |
License payments | | Specialty | | | 6,000 | | | | — | | | | 6,000 | | | | — | |
GSK collaboration | | Specialty | | | 3,778 | | | | — | | | | 9,896 | | | | — | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Total alliance revenue | | | | | | $ | 32,754 | | | $ | 15,243 | | | $ | 70,333 | | | $ | 42,821 | |
| | | | | | | | | | | | | | | | |
| | |
(a) | | Product sales in the U.S., Australia, Branded generics — Latin America and Branded generics — Europe in the three months ended September 30, 2009 include the sales of products acquired in the fourth quarter of 2008 from Coria in the U.S. and DermaTech in Australia, products acquired in the second quarter 2009 from Emo-Farm in Branded generics — Europe and in Australia and products acquired in the third quarter 2009 from Tecnofarma S.A de C.V. in Branded generics — Latin America of $10.8 million, $3.0 million, $3.0 million, $1.8 million and $4.7 million, and $30.0 million, $6.7 million, $5.3 million, $2.3 million and $4.7 million in the nine months ended September 30, 2009, respectively. |
|
(b) | | Note: Currency effect for constant currency sales is determined by comparing 2009 reported amounts adjusted to exclude currency impact, calculated using 2008 monthly average exchange rates, to the actual 2008 reported amounts. Constant currency sales is not a GAAP-defined measure of revenue growth. Constant currency sales as defined and presented by us may not be comparable to similar measures reported by other companies. |
|
(c) | | See footnote (a) to Table 2. |
Table 4
Valeant Pharmaceuticals International
Statement of Cost of Goods Sold and Non-GAAP Operating Income — by Segment
For the Three and Nine Months Ended September 30, 2009 and 2008
(In thousands)
4.1 Cost of goods sold
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
| | | | | | % of | | | | | | | % of | | | | | | | % of | | | | | | | % of | |
| | | | | | product | | | | | | | product | | | | | | | product | | | | | | | product | |
| | 2009 | | | sales | | | 2008 | | | sales | | | 2009 | | | sales | | | 2008 | | | sales | |
Specialty pharmaceuticals | | $ | 22,246 | | | | 22 | % | | $ | 15,918 | | | | 23 | % | | $ | 55,790 | | | | 20 | % | | $ | 45,585 | | | | 21 | % |
Branded generics — Latin America | | | 13,141 | | | | 32 | % | | | 13,600 | | | | 32 | % | | | 30,637 | | | | 28 | % | | | 37,145 | | | | 37 | % |
Branded generics — Europe | | | 16,852 | | | | 42 | % | | | 13,191 | | | | 33 | % | | | 48,253 | | | | 44 | % | | | 44,489 | | | | 38 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Corporate | | | 56 | | | | | | | | (11 | ) | | | | | | | 62 | | | | | | | | (892 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | $ | 52,295 | | | | 29 | % | | $ | 42,698 | | | | 28 | % | | $ | 134,742 | | | | 27 | % | | $ | 126,327 | | | | 29 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
4.2 Non-GAAP operating income excluding currency impact(a)(b)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | |
| | September 30, | |
| | | | | | | | | | | | | | 2009 | | | | | | | | | | | |
| | | | | | | | | | 2009 | | | excluding | | | | | | | | | | | |
| | | | | | % of | | | currency | | | currency | | | % of | | | | | | | % of | |
| | 2009 | | | revenue | | | impact | | | impact | | | revenue | | | 2008 | | | revenue | |
Specialty pharmaceuticals | | $ | 64,449 | | | | 51 | % | | $ | 680 | | | $ | 65,129 | | | | 50 | % | | $ | 5,043 | | | | 7 | % |
Branded generics — Latin America | | | 13,078 | | | | 32 | % | | | 3,118 | | | | 16,196 | | | | 32 | % | | | 11,171 | | | | 26 | % |
Branded generics — Europe | | | 12,009 | | | | 30 | % | | | 3,616 | | | | 15,625 | | | | 30 | % | | | 16,005 | | | | 40 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 89,536 | | | | 43 | % | | | 7,414 | | | | 96,950 | | | | 42 | % | | | 32,219 | | | | 21 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Alliances & Corporate | | | (1,254 | ) | | | | | | | — | | | | (1,254 | ) | | | | | | | (1,189 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | $ | 88,282 | | | | 40 | % | | $ | 7,414 | | | $ | 95,696 | | | | 39 | % | | $ | 31,030 | | | | 18 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
|
| | Nine Months Ended | |
| | September 30, | |
| | | | | | | | | | | | | | 2009 | | | | | | | | | | | |
| | | | | | | | | | 2009 | | | excluding | | | | | | | | | | | |
| | | | | | % of | | | currency | | | currency | | | % of | | | | | | | % of | |
| | 2009 | | | revenue | | | impact | | | impact | | | revenue | | | 2008 | | | revenue | |
Specialty pharmaceuticals | | $ | 158,533 | | | | 47 | % | | $ | 4,616 | | | $ | 163,149 | | | | 47 | % | | $ | 9,532 | | | | 4 | % |
Branded generics — Latin America | | | 40,692 | | | | 38 | % | | | 11,384 | | | | 52,076 | | | | 38 | % | | | 16,047 | | | | 16 | % |
Branded generics — Europe | | | 29,303 | | | | 27 | % | | | 10,137 | | | | 39,440 | | | | 26 | % | | | 35,779 | | | | 31 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 228,528 | | | | 41 | % | | | 26,137 | | | | 254,665 | | | | 40 | % | | | 61,358 | | | | 14 | % |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Alliances & Corporate | | | (6,457 | ) | | | | | | | — | | | | (6,457 | ) | | | | | | | (490 | ) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | $ | 222,071 | | | | 38 | % | | $ | 26,137 | | | $ | 248,208 | | | | 37 | % | | $ | 60,868 | | | | 13 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | |
(a) | | See footnote (a) to Table 2 and footnote (b) to Table 3. |
|
(b) | | Non-GAAP operating income of $88.3 million and $222.1 million for the three and nine months ended September 30, 2009 excludes the following GAAP items from GAAP operating income of $67.5 million and $161.4 million: acquisition transaction fees included within SG&A of $2.8 million and $3.8 million, special charges and credits including acquired in-process research and development of $0 and $2.0 million, restructuring, asset impairments and dispositions of $0.2 million and $3.2 million and amortization expense of $17.6 million and $51.7 million, respectively. Non-GAAP operating income of $31.0 million and $60.9 million for the three and nine months ended September 30, 2008 excludes the following GAAP items from GAAP operating income of $16.0 million and $19.0 million: restructuring, asset impairments and dispositions of $3.5 million and $4.3 million and amortization expense of $11.5 million and $37.6 million, respectively. |
Table 5
Valeant Pharmaceuticals International
Consolidated Balance Sheet and Other Data
(In thousands)
5.1 Cash
| | | | | | | | |
| | As of | | | As of | |
| | September 30, | | | December 31, | |
| | 2009 | | | 2008 | |
| | | | | | | | |
Cash and cash equivalents | | $ | 261,559 | | | $ | 199,582 | |
Marketable securities | | | 124,350 | | | | 19,193 | |
| | | | | | |
Total cash and marketable securities | | $ | 385,909 | | | $ | 218,775 | |
| | | | | | |
5.2 Summary of Cash Flow Statement
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
| | 2009 | | | 2008 | | | 2009 | | | 2008 | |
Cash flow provided by (used in): | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Operating activities, continuing operations (GAAP) | | $ | 51,580 | | | $ | 2,589 | | | $ | 133,863 | | | $ | 58,646 | |
Effect of ASC 470-20 (FSP APB 14-1) (a)(b) | | | 12,351 | | | | — | | | | 35,338 | | | | — | |
Acquisition transaction fees (a)(b) | | | 861 | | | | — | | | | 1,727 | | | | — | |
| | | | | | | | | | | | |
Operating activities, continuing operations (Non-GAAP) (a)(b) | | | 64,792 | | | | 2,589 | | | | 170,928 | | | | 58,646 | |
Operating activities, discontinued operations | | | (426 | ) | | | 13,986 | | | | (2,860 | ) | | | 9,632 | |
| | | | | | | | | | | | | | | | |
Investing activities (GAAP) (c) | | | (48,157 | ) | | | 424,567 | | | | (235,751 | ) | | | 512,284 | |
Acquisition transaction fees (a)(b) | | | (861 | ) | | | — | | | | (1,727 | ) | | | — | |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Investing activities (Non-GAAP) (a)(b)(c) | | | (49,018 | ) | | | 424,567 | | | | (237,478 | ) | | | 512,284 | |
| | | | | | | | | | | | | | | | |
Financing activities (GAAP) (c) | | | (90,401 | ) | | | (374,017 | ) | | | 171,374 | | | | (373,463 | ) |
Effect of ASC 470-20 (FSP APB 14-1) (a)(b) | | | (12,351 | ) | | | — | | | | (35,338 | ) | | | — | |
| | | | | | | | | | | | |
Financing activities (Non-GAAP) (a)(b)(c) | | | (102,752 | ) | | | (374,017 | ) | | | 136,036 | | | | (373,463 | ) |
| | | | | | | | | | | | | | | | |
Effect of exchange rate changes on cash and cash equivalents (c) | | | 3,343 | | | | (12,162 | ) | | | (4,649 | ) | | | 4,799 | |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Net increase (decrease) in cash and cash equivalents (c) | | | (84,061 | ) | | | 54,963 | | | | 61,977 | | | | 211,898 | |
Net increase (decrease) in marketable securities (c) | | | 16,991 | | | | (33,935 | ) | | | 105,157 | | | | (2,373 | ) |
| | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Net increase (decrease) in cash and marketable securities (c) | | $ | (67,070 | ) | | $ | 21,028 | | | $ | 167,134 | | | $ | 209,525 | |
| | | | | | | | | | | | |
| | |
(a) | | See footnote (a) to Table 2. |
|
(b) | | Cash flow for the three and nine months ended September 30, 2009 includes $12.4 million and $35.3 million relating to payments of accreted interest on long-term debt and notes payable made during these periods as determined by and pursuant to ASC 470-20 (FSP APB 14-1), $0 million and $9.0 million for acquisition transaction fees related to the purchase of Emo-Farm in Poland, $0.7 million and $0.7 million for acquisition fees related to the purchase of Tecnofarma in Mexico and $0.2 million and $0.2 million for acquisition fees related to the purchase of PFI in Australia, respectively. |
|
(c) | | Includes results from discontinued operations. |
5.3 GSK Collaboration — Retagibine
| | | | |
| | Three Months Ended | |
| | September 30, | |
| | | | |
Valeant SG&A | | $ | 9 | |
Valeant R&D | | | 7,456 | |
| | | |
| | | 7,465 | |
GSK incurred cost | | | 10,019 | |
| | | |
| | $ | 17,484 | |
| | | |
| | | | |
Equalization (difference between individual partner costs and 50% of total) | | $ | (1,277 | ) |
| | | |
| | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2009 | |
| | | | | | Alliance | | | | | | | |
| | Balance sheet | | | revenue | | | SG&A | | | R&D | |
Accounting impact | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Upfront payment from GSK | | $ | 125,000 | | | $ | — | | | $ | — | | | $ | — | |
Release from upfront payment in prior quarters | | | (30,481 | ) | | | — | | | | — | | | | — | |
Incurred cost in current quarter | | | — | | | | — | | | | 9 | | | | 7,456 | |
Release from upfront payment in current quarter | | | (12,520 | ) | | | (3,778 | ) | | | (358 | ) | | | (8,384 | ) |
| | | | | | | | | | | | | | | |
Remaining upfront payment from GSK | | $ | 81,999 | | | | — | | | | — | | | | — | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Equalization payable to GSK | | $ | (1,277 | ) | | | — | | | | 349 | | | | 928 | |
| | | | | | | | | | | | |
| | | | | | $ | (3,778 | ) | | $ | — | | | $ | — | |
| | | | | | | | | | | | | |
| | |
Valeant Pharmaceuticals International Reconciliation of Product Sales Excluding Acquisitions and Currency Impact For the Three Months Ended September 30, 2009 and 2008 (In thousands) | | Supplemental Table |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | Three Months Ended | | | | | | | Three Months Ended | | | | |
| | September 30, 2009 | | | September 30, 2008 | | | | |
| | | | | | | | | | | | | | | | | | | | | | Q3 2009 | |
| | | | | | | | | | | | | | 2009 | | | | | | | growth at | |
| | | | | | 2009 | | | | | | | excluding | | | | | | | constant | |
| | | | | | acquisition | | | 2009 | | | currency & | | | | | | | currency, net | |
| | 2009 | | | impact at | | | currency | | | acquisition | | | | | | | of | |
| | as reported | | | 2009 rates | | | impact | | | impact | | | 2008 as reported | | | acquisitions | |
Specialty pharmaceuticals | | | | | | | | | | | | | | | | | | | | | | | | |
U.S. | | $ | 75,356 | | | $ | (10,756 | ) | | $ | — | | | $ | 64,600 | | | $ | 48,537 | | | | 33 | % |
Canada | | | 15,831 | | | | — | | | | 1,012 | | | | 16,843 | | | | 15,203 | | | | 11 | % |
Australia | | | 10,429 | | | | (4,857 | ) | | | 446 | | | | 6,018 | | | | 6,384 | | | | -6 | % |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Specialty pharmaceuticals product sales | | | 101,616 | | | | (15,613 | ) | | | 1,458 | | | | 87,461 | | | | 70,124 | | | | 25 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Branded generics — Latin America product sales | | | 40,679 | | | | (4,673 | ) | | | 8,786 | | | | 44,792 | | | | 42,627 | | | | 5 | % |
Branded generics — Europe product sales | | | 40,234 | | | | (3,038 | ) | | | 11,050 | | | | 48,246 | | | | 40,430 | | | | 19 | % |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total product sales | | $ | 182,529 | | | $ | (23,324 | ) | | $ | 21,294 | | | $ | 180,499 | | | $ | 153,181 | | | | 18 | % |
| | | | | | | | | | | | | | | | | | | |
See footnote (a) to Table 2.