Net Revenues Increased 120% to $17.1 Million from $7.8 Million in the Third Quarter of 2010

Transcription

1 Pernix Therapeutics Holdings Reports Third Quarter 2011 Financial Results November 15, :55 PM ET Net Revenues Increased 120% to $17.1 Million from $7.8 Million in the Third Quarter of 2010 Strong Net Revenue Growth Due Primarily to the Launches of CEDAX 180 mg Formulation, Natroba, and Generic Products Adjusted EBITDA Increased 34% to $3.6 Million from $2.7 Million in the Third Quarter of 2010 THE WOODLANDS, Texas, November 15, 2011 Pernix Therapeutics Holdings, Inc. ( Pernix ) (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, today announced financial results for the three and nine months ended September 30, Financial Results For the third quarter of 2011, net revenues increased by 120% to $17.1 million, compared to $7.8 million for the third quarter of The increase in net revenues was due primarily to higher volume of product sales resulting from the launch of the Company s new CEDAX product formulation, Natroba, and certain generic products. Net income for the third quarter of 2011 was $2.0 million, or $0.08 per basic and diluted share, compared to $2.4 million, or $0.10 per basic and diluted share for the third quarter of Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA, a non-gaap measure) increased 34% to $3.6 million for the third quarter of 2011, compared to $2.7 million for the third quarter of See the table at the end of this press release for a reconciliation of EBITDA and adjusted EBITDA to net income. Cooper Collins, President and Chief Executive Officer of Pernix, said, Pernix continued to deliver strong revenue growth, driven by the new CEDAX 180mg formulation, the launch of Natroba, and additional generic products. Going forward, we believe the Company is in a solid financial position and will continue to grow its branded pediatric and generic businesses. We are also currently evaluating licensing and acquisition opportunities to expand into other therapeutic areas that are expected to further broaden our product portfolio and leverage our business platform. Selling, general and administrative ( SG&A ) expenses in the third quarter of 2011 increased to $5.4 million, compared to $3.5 million for the third quarter of The increase was primarily due to higher salaries, bonuses, commissions, incentives and stock compensation expense. The increase in commissions was due to greater gross sales and the higher commission rates paid on sales of Natroba. Depreciation and amortization expense increased to $0.6 million for the third quarter of 2011, compared to $0.3 million for the third quarter of The increase is due to the amortization under certain acquisition agreements, including CEDAX and Macoven. The Company also recognized $0.1 million in expenses related to its joint venture with SEEK for the development of Theobromine during the third quarter of The Company recognized an income tax expense of $0.9 million for the third quarter of 2011 and For the nine months ended September 30, 2011, net revenues increased by 87% to $39.2 million, compared to $21.0 million for the prior year period. The increase in net revenues was due primarily to higher volume of product sales resulting from the launch of the Company s new CEDAX product formulation, Natroba, and certain new generic products. Net income for the nine months ended September 30, 2011 was $4.5 million, or $0.19 per basic and diluted share, compared to $7.9 million, or $0.33 per basic and diluted share, for the prior year period. Adjusted EBITDA increased 17% to $8.8 million for the nine months ended September 30, 2011, compared to $7.5 million for the prior year period. See the table at the end of this press release for a reconciliation of EBITDA and adjusted EBITDA to net income. Page 1/5

2 SG&A expenses for the nine months ended September 30, 2011 increased to $14.9 million, compared to $9.4 million for the nine months ended September 30, The increase was primarily due to similar factors that impacted SG&A in the third quarter of Depreciation and amortization expenses increased to $1.7 million for the nine months ended September 30, 2011, compared to $0.5 million for the prior year period. The Company also recognized $0.7 million in expenses related to its joint venture with SEEK for the development of Theobromine during the nine months ended September 30, For the nine months ended September 30, 2011, the Company recognized an income tax expense of $2.5 million, compared to an income tax expense of $45,000 for the prior year period. Business Update Natroba (spinosad) Topical Suspension, 0.9% Under the exclusive co-promotion agreement with ParaPRO, LLC, Pernix launched Natroba with its pediatric sales force in August Natroba received U.S. Food and Drug Administration (FDA) approval in January 2011 as a prescription medication indicated for the topical treatment of head lice infestations in patients four years of age and older. Natroba treats head lice using spinosad, a compound derived from a soil microbe. In Phase III clinical studies, Natroba was shown to be more effective at eliminating head lice infestations than permethrin 1%. Natroba is a novel therapy that does not require nit combing. The U.S. Centers for Disease Control and Prevention estimates between 6 to 12 million cases of head lice infestations each year in the United States. Most cases of head lice occur in children ages 3 to 12 years old. It is a highly-communicable condition among school-age children. Natroba is a prescription, topical treatment for use only on the hair and scalp as directed by a physician. The most common adverse events were: application site redness (3%), redness and irritation of the eyes (2%), and application site irritation (1%). For additional safety information, see the patient and full prescribing information at Theobromine (BC 1036) In March 2011, Pernix and its joint venture partner SEEK, a leading U.K. drug discovery and development group, appointed a financial advisor in connection with an auction of Theobromine (BC 1036), a non-codeine, non-narcotic, antitussive drug candidate in late-stage development for the treatment of persistent cough. While the joint venture has not received an offer to purchase the Theobromine assets that was acceptable by its Board of Directors, the joint venture continues to evaluate opportunities and expects to continue discussions with interested parties to maximize the value of this asset. The joint venture expects to initiate its pivotal Phase III trial in the European Union in the first quarter of 2012, and is currently evaluating over-the-counter strategies in certain countries, including the United States. Financial Position As of September 30, 2011, the Company had $27.6 million of cash and cash equivalents. On July 27, 2011, Pernix completed an underwritten registered direct offering of 4,000,000 shares of common stock at a price of $7.00 per share. The offering, led by Aisling Capital and OrbiMed Advisors LLC, consisted of 3,000,000 shares of primary stock and 1,000,000 shares of secondary stock. Net proceeds from the sale of the shares of common stock sold by the Company, after deducting underwriting commissions and offering expenses, were $19.3 million. Conference Call Information Management will host a conference call today at 9:00 am EST to discuss its financial results for the third quarter of The conference call will feature remarks from Cooper Collins, President and Chief Executive Officer, and Tracy Clifford, Page 2/5

3 Chief Financial Officer. To participate in the live conference call, please dial (877) (U.S.) or (719) (International), and provide passcode A live webcast of the call will also be available on the investor relations section of the Company s website, Please allow extra time prior to the webcast to register for the webcast and to download and install any necessary audio software. A replay of the call will be available through November 22, To access the replay, please dial (888) (U.S.) or (719) (International), and provide passcode An online archive of the webcast will be available on the Company s website for 30 days following the call. About Pernix Therapeutics Holdings, Inc. Pernix Therapeutics Holdings, Inc. is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded and generic pharmaceutical products primarily for the pediatric market. The Company manages a portfolio of branded and generic products, and Theobromine, a non-codeine, cough suppressant product candidate in development. The Company s branded products include CEDAX, an antibiotic for middle ear infections, Natroba, a topical treatment for head lice marketed under an exclusive co-promotion agreement with ParaPRO, LLC, and a family of prescription treatments for cough and cold (Brovex, Aldex and Pediatex). The Company promotes its branded products through an established U.S. sales force and markets generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals. Founded in 1999, the Company is based in The Woodlands, TX. Additional information about Pernix is available on the Company s website located at Non-GAAP Financial Measures Pernix is disclosing non-gaap financial measures in this press release. Primarily due to acquisitions, Pernix believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with U.S. generally accepted accounting principles (GAAP). In addition to disclosing its financial results determined in accordance with GAAP, Pernix is disclosing non-gaap results that exclude items such as amortization expense and certain other expense and revenue items in order to supplement investors and other readers understanding and assessment of the Company s financial performance. Whenever Pernix uses a non-gaap measure, it will provide a reconciliation of non-gaap financial measures to the most closely applicable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-gaap measures set forth herein and should consider non-gaap measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Cautionary Notice Regarding Forward-Looking Statements The Company wishes to caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. No assurances can be given regarding the future performance of the Company. The Company wishes to advise readers that factors could affect the Company s financial performance and could cause the Company s actual results for future periods to differ materially from any opinions or statements expressed with respect to future periods in any current statements. The Company does not undertake, and specifically declines any obligation, to update any forwardlooking statements to reflect events or circumstances occurring after the date such statements are made. PERNIX THERAPEUTICS HOLDINGS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS ASSETS Current assets: September 30,2011 (unaudited) December 31, 2010 Page 3/5

4 Cash and cash equivalents $ 27,563,124 $ 8,260,059 Restricted cash 501,906 Accounts receivable, net 23,649,809 14,758,240 Inventory, net 7,518,636 4,145,734 Prepaid expenses and other current assets 1,653,244 1,930,062 Deferred tax assets 4,330,000 2,494,000 Total current assets 64,714,813 32,090,001 Property and equipment, net 1,279,233 1,213,850 Other assets: Investment in joint venture 1,810,949 1,502,814 Intangible assets, net 9,458,971 10,961,900 Other long-term assets 264, ,967 Total assets $ 77,528,933 $ 46,033,532 LIABILITIES Current liabilities: Accounts payable $ 4,767,906 $ 2,248,342 Accrued expenses 3,354,439 2,167,525 Accrued allowances 15,565,888 10,488,674 Income taxes payable 1,278,201 2,149,052 Contract payable 1,290,000 2,200,000 Total current liabilities 26,256,434 19,253,593 Long-term liabilities Line of credit 6,000,000 5,000,000 Contracts payable 900,000 1,800,000 Deferred income taxes 497,000 1,075,000 Total liabilities 33,653,434 27,128,593 Commitments and contingencies EQUITY Preferred stock, $0.01 par value, 10,000,000 shares authorized, no shares outstanding Common stock, $.01 par value, 90,000,000 shares authorized, 27,795,931 and 24,698,594 issued, 25,725,064 and 22,627,727 outstanding at September 30, 2011 and December 31, 2010, respectively Treasury stock, at cost (2,070,867 shares held at September 30, 2011 and December 31, 2010, respectively) 257, ,277 (3,751,890) (3,751,890) Additional paid-in capital 29,402,747 8,934,735 Retained earnings 17,967,391 13,495,817 Total equity 43,875,499 18,904,939 Total liabilities and equity $ 77,528,933 $ 46,033,532 Back to Press Releases PERNIX THERAPEUTICS HOLDINGS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, Page 4/5

5 Net sales $ 17,064,196 $ 7,753,086 $ 39,203,944 $ 20,947,836 Costs and expenses: Cost of product sales 7,815,353 1,410,193 13,699,890 3,269,992 Selling, general and administrative expenses 5,411,154 3,505,467 14,924,749 9,383,584 Research and development expense 147, , , ,986 Loss from the operations of the joint venturewith SEEK 100, ,865 Royalties expense, net 32, , , ,307 Depreciation and amortization expense 603, ,004 1,690, ,973 Total costs and expenses 14,110,248 5,673,707 32,102,406 14,257,842 Income from operations 2,953,948 2,079,379 7,101,538 6,689,994 Other income (expense): Other income 277, ,762 Gain from bargain purchase 881, ,950 Interest expense, net (37,300 ) 8,803 (129,964 ) 16,447 Total other income, net (37,300 ) 1,168,140 (129,964 ) 1,176,159 Income before income taxes 2,916,648 3,247,519 6,971,574 7,866,153 Income tax provision 922, ,747 2,500,000 45,374 Net income $ 1,994,648 $ 2,385,772 $ 4,471,574 $ 7,820,779 Net income per share, basic $ 0.08 $ 0.10 Supplemental Financial Information The following table presents a reconciliation of Pernix s net income to EBITDA and Adjusted EBITDA. The Company defines EBITDA as net income plus interest, income tax expense, depreciation and amortization and presents these measures to assist investors in evaluating Pernix s operating performance and comparing the Company s results with those of other companies. EBITDA and adjusted EBITDA should not be considered in isolation from or as a substitute for net income. Three Months Ended Nine Months Ended September 30, September 30, GAAP Net Income $1,994,468 $2,385,772 $ 4,471,574 $ 7,820,779 Plus: Income tax expense 922, ,747 2,500,000 45,374 Depreciation and amortization 603, ,004 1,690, ,973 Interest expense, net 37,300 (8,803 ) 129,964 (16,447 ) EBITDA 3,557,296 3,538,720 8,792,365 8,408,679 Non-recurring items: Gain from bargain purchase (881,950 ) (881,950 ) Adjusted EBITDA $3,557,296 $2,656,770 $ 8,792,365 $ 7,526,729 Page 5/5