Salix Pharmaceuticals Reports 3Q2012 Results
Salix markets XIFAXAN ® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP ® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), OSMOPREP ® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO ® (mesalamine) extended-release capsules 0.375 g, METOZOLV ® ODT (metoclopramide HCl), RELISTOR ® (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA ®, DEFLUX ®, PEPCID ® (famotidine) for Oral Suspension, Oral Suspension DIURIL ® (Chlorothiazide), AZASAN ® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC ® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC ® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT ® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT ® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR ® , LUMACAN ™ and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP, AZASAN and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.
For more information, please visit our Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook ( www.facebook.com/SalixPharma). Information on our Twitter feed, Facebook page and web site is not incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation; market acceptance for approved products; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.| Salix Pharmaceuticals, Ltd. | |||||||||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||||||||
| (In thousands, except per share data) | Three Months Ended | Nine Months Ended | |||||||||||||||||||
| September 30, | September 30, | September 30, | September 30, | ||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||||||||
| Revenues: | |||||||||||||||||||||
| Net product revenues | $ | 185,132 | $ | 146,247 | $ | 537,271 | $ | 385,306 | |||||||||||||
| Costs and Expenses: | |||||||||||||||||||||
| Cost of products sold | 26,471 | 24,056 | 93,918 | 67,884 | |||||||||||||||||
| Amortization of product rights and intangible assets | 11,345 | 2,890 | 34,034 | 8,017 | |||||||||||||||||
| Research and development | 32,819 | 24,814 | 86,677 | 85,294 | |||||||||||||||||
| Selling, general and administrative | 61,543 | 41,439 | 187,266 | 132,786 | |||||||||||||||||
| Intangible asset impairment charge | 41,600 | - | 41,600 | - | |||||||||||||||||
| Change in acquisition-related contingent consideration | (31,398 | ) | - | (31,398 | ) | - | |||||||||||||||
| Total costs and expenses | 142,380 | 93,199 | 412,097 | 293,981 | |||||||||||||||||
| Income from operations | 42,752 | 53,048 | 125,174 | 91,325 | |||||||||||||||||
| Loss on extinguishment of debt | - | - | (14,369 | ) | - | ||||||||||||||||
| Interest expense | (15,692 | ) | (8,080 | ) | (39,591 | ) | (23,932 | ) | |||||||||||||
| Interest and other income | 279 | 509 | 10,409 | 2,082 | |||||||||||||||||
| Income before income tax | 27,339 | 45,477 | 81,623 | 69,475 | |||||||||||||||||
| Income tax expense | 10,803 | 11,198 | 35,000 | 15,671 | |||||||||||||||||
| Net Income | $ | 16,536 | $ | 34,279 | $ | 46,623 | $ | 53,804 | |||||||||||||
| Income per share, basic | $ | 0.28 | $ | 0.58 | $ | 0.79 | $ | 0.92 | |||||||||||||
| Income per share, diluted | $ | 0.26 | $ | 0.55 | $ | 0.73 | $ | 0.89 | |||||||||||||
| Shares used in computing net income per share, basic | 58,755 | 59,076 | 58,671 | 58,573 | |||||||||||||||||
| Shares used in computing net income per share, diluted | 62,983 | 65,160 | 63,689 | 65,405 | |||||||||||||||||
| Reconciliation of GAAP Amounts to Non-GAAP Amounts: | |||||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||||
| We are disclosing our non-GAAP Condensed Consolidated Statements of Operations, as adjusted, to eliminate the impact of the $10.0 million Lupin payment that occured in February 2011, the loss on extinguishment of debt and non-cash adjustments related to the repurchase of a portion of our 2028 Notes in March 2012, the intangible asset impairment charge and change in acquisition-related contingent consideration that occurred in September 2012, the difference between income taxes paid and income taxes expensed, and non-cash depreciation, amortization, stock-based compensation and convertible debt interest expenses that occured in the three-month and nine-month periods ended September 30, 2012 and 2011, respectively. We believe these non-GAAP measures might provide investors additional relevant information, in part for purposes of historical comparison. In addition, we use these non-GAAP measures to analyze our performance in more detail and with better historical comparability; however, you should be aware that non-GAAP measures are not superior to nor a substitute for the comparable GAAP measures. A reconciliation of our non-GAAP measures to the comparable GAAP measures follows. | |||||||||||||||||||||
| Three Months Ended | Three Months Ended | ||||||||||||||||||||
| September 30, | September 30, | September 30, | September 30, | September 30, | September 30, | ||||||||||||||||
| 2012 | 2012 - Non-GAAP Adjustments | 2012- Non-GAAP as adjusted | 2011 | 2011 - Non-GAAP Adjustments | 2011 - Non-GAAP as adjusted | ||||||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||||||
| Revenues: | |||||||||||||||||||||
| Net product revenues | $ | 185,132 | $ | - | $ | 185,132 | $ | 146,247 | $ | - | $ | 146,247 | |||||||||
| Costs and Expenses: | |||||||||||||||||||||
| Cost of products sold | 26,471 | - | 26,471 | 24,056 | - | 24,056 | |||||||||||||||
| Amortization of product rights and intangible assets | 11,345 | (11,345 | ) | - | 2,890 | (2,890 | ) | - | |||||||||||||
| Research and development | 32,819 | (1,455 | ) | 31,364 | 24,814 | (2,531 | ) | 22,283 | |||||||||||||
| Selling, general and administrative | 61,543 | (5,824 | ) | 55,719 | 41,439 | (4,124 | ) | 37,315 | |||||||||||||
| Intangible asset impairment charge | 41,600 | (41,600 | ) | - | - | - | - | ||||||||||||||
| Change in acquisition-related contingent consideration | (31,398 | ) | 31,398 | - | - | - | - | ||||||||||||||
| Total costs and expenses | 142,380 | (28,826 | ) | 113,554 | 93,199 | (9,545 | ) | 83,654 | |||||||||||||
| Income from operations | 42,752 | 28,826 | 71,578 | 53,048 | 9,545 | 62,593 | |||||||||||||||
| Loss on extinguishment of debt | - | - | - | - | - | - | |||||||||||||||
| Interest expense | (15,692 | ) | 10,380 | (5,312 | ) | (8,080 | ) | 4,882 | (3,198 | ) | |||||||||||
| Interest and other income | 279 | - | 279 | 509 | - | 509 | |||||||||||||||
| Income before income tax | 27,339 | 39,206 | 66,545 | 45,477 | 14,427 | 59,904 | |||||||||||||||
| Income tax expense | 10,803 | (3,969 | ) | 6,834 | 11,198 | - | 11,198 | ||||||||||||||
| Net Income, as adjusted | $ | 16,536 | $ | 43,175 | $ | 59,711 | $ | 34,279 | $ | 14,427 | $ | 48,706 | |||||||||
| Income per share, basic | $ | 0.28 | $ | 0.73 | $ | 1.02 | $ | 0.58 | $ | 0.24 | $ | 0.82 | |||||||||
| Income per share, diluted | $ | 0.26 | $ | 0.69 | $ | 0.95 | $ | 0.55 | $ | 0.22 | $ | 0.77 | |||||||||
| Shares used in computing net income per share, basic | 58,755 | 58,755 | 58,755 | 59,076 | 59,076 | 59,076 | |||||||||||||||
| Shares used in computing net income per share, diluted | 62,983 | 62,983 | 62,983 | 65,160 | 65,160 | 65,160 | |||||||||||||||
| Nine Months Ended | Nine Months Ended | ||||||||||||||||||||
| September 30, | September 30, | September 30, | September 30, | September 30, | September 30, | ||||||||||||||||
| 2012 | 2012 - Non-GAAP Adjustments | 2012- Non-GAAP as adjusted | 2011 | 2011 - Non-GAAP Adjustments | 2011 - Non-GAAP as adjusted | ||||||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||||||||
| Revenues: | |||||||||||||||||||||
| Net product revenues | $ | 537,271 | $ | - | $ | 537,271 | $ | 385,306 | $ | - | $ | 385,306 | |||||||||
| Costs and Expenses: | |||||||||||||||||||||
| Cost of products sold | 93,918 | - | 93,918 | 67,884 | - | 67,884 | |||||||||||||||
| Amortization of product rights and intangible assets | 34,034 | (34,034 | ) | - | 8,017 | (8,017 | ) | - | |||||||||||||
| Research and development | 86,677 | (3,997 | ) | 82,680 | 85,294 | (15,816 | ) | 69,478 | |||||||||||||
| Selling, general and administrative | 187,266 | (15,990 | ) | 171,276 | 132,786 | (11,265 | ) | 121,521 | |||||||||||||
| Intangible asset impairment charge | 41,600 | (41,600 | ) | - | - | - | - | ||||||||||||||
| Change in acquisition-related contingent consideration | (31,398 | ) | 31,398 | - | - | - | - | ||||||||||||||
| Total costs and expenses | 412,097 | (64,223 | ) | 347,874 | 293,981 | (35,098 | ) | 258,883 | |||||||||||||
| Income from operations | 125,174 | 64,223 | 189,397 | 91,325 | 35,098 | 126,423 | |||||||||||||||
| Loss on extinguishment of debt | (14,369 | ) | 14,369 | - | - | - | - | ||||||||||||||
| Interest expense | (39,591 | ) | 25,262 | (14,329 | ) | (23,932 | ) | 14,334 | (9,598 | ) | |||||||||||
| Interest and other income | 10,409 | (9,325 | ) | 1,084 | 2,082 | - | 2,082 | ||||||||||||||
| Income before income tax | 81,623 | 94,529 | 176,152 | 69,475 | 49,432 | 118,907 | |||||||||||||||
| Income tax expense | 35,000 | (13,333 | ) | 21,667 | 15,671 | - | 15,671 | ||||||||||||||
| Net Income, as adjusted | $ | 46,623 | $ | 107,862 | $ | 154,485 | $ | 53,804 | $ | 49,432 | $ | 103,236 | |||||||||
| Income per share, basic | $ | 0.79 | $ | 1.84 | $ | 2.63 | $ | 0.92 | $ | 0.84 | $ | 1.76 | |||||||||
| Income per share, diluted | $ | 0.73 | $ | 1.69 | $ | 2.43 | $ | 0.89 | $ | 0.76 | $ | 1.64 | |||||||||
| Shares used in computing net income per share, basic | 58,671 | 58,671 | 58,671 | 58,573 | 58,573 | 58,573 | |||||||||||||||
| Shares used in computing net income per share, diluted | 63,689 | 63,689 | 63,689 | 65,405 | 65,405 | 65,405 | |||||||||||||||
| Salix Pharmaceuticals, Ltd. | |||||||||||||||||||||
| Condensed Consolidated Balance Sheets | |||||||||||||||||||||
| (In thousands) | September 30, | December 31, | |||||||||||||||||||
| 2012 | 2011 | ||||||||||||||||||||
| (unaudited) | (audited) | ||||||||||||||||||||
| Assets | |||||||||||||||||||||
| Cash and cash equivalents | $ | 775,903 | $ | 292,814 | |||||||||||||||||
| Accounts receivable, net | 213,766 | 151,207 | |||||||||||||||||||
| Inventory, net | 71,654 | 49,205 | |||||||||||||||||||
| Other assets | 759,578 | 819,743 | |||||||||||||||||||
| Total Assets | $ | 1,820,901 | $ | 1,312,969 | |||||||||||||||||
| Liabilities and Stockholders' Equity | |||||||||||||||||||||
| Accounts payable and other liabilities | $ | 1,288,306 | $ | 763,332 | |||||||||||||||||
| Total liabilities | 1,288,306 | 763,332 | |||||||||||||||||||
| Common stock | 59 | 59 | |||||||||||||||||||
| Additional paid-in-capital | 621,474 | 685,315 | |||||||||||||||||||
| Other comprehensive loss | 65 | (111 | ) | ||||||||||||||||||
| Accumulated deficit | (89,003 | ) | (135,626 | ) | |||||||||||||||||
| Total stockholders' equity | 532,595 | 549,637 | |||||||||||||||||||
| Total Liabilities and Stockholders' Equity | $ | 1,820,901 | $ | 1,312,969 | |||||||||||||||||
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