Pernix Therapeutics Reports Third Quarter 2012 Financial Results

Third Quarter of 2012 Net Revenues Increased Approximately 6.3% to $18.1 Million From $17.1 Million in the Third Quarter of 2011

Announced Agreement to Acquire Cypress Pharmaceuticals and Hawthorn Pharmaceuticals

Macoven Launched Generic Spinosad for the Treatment of Head Lice

Completed Acquisition of Great Southern Laboratories

THE WOODLANDS, Texas--()--Pernix Therapeutics Holdings, Inc. (“Pernix” or the “Company”) (NYSE MKT: PTX), a specialty pharmaceutical company, today announced financial results for the third quarter and nine months ended September 30, 2012.

Financial Results

For the third quarter of 2012, net revenues increased 6.3% to $18.1 million, compared to $17.1 million for the third quarter of 2011. Total net revenues consisted of 56% branded products, 32% generic products, and 12% manufacturing revenues in the third quarter of 2012.

The net loss for the third quarter of 2012 was approximately $(0.3) million, or $(0.01) per basic and diluted share, compared to net income of $2.0 million, or $0.08 per basic and diluted share, for the third quarter of 2011.

Cooper Collins, President and Chief Executive Officer of Pernix, said, “During the third quarter, we launched Omeclamox-Pak®, which is steadily making progress. Macoven introduced generic Spinosad for the treatment of head lice, which is already gaining traction in just two months after the launch, and we have made efficiency and quality improvements at Great Southern Labs. Today, we announced that we entered into an agreement to acquire Cypress Pharmaceuticals and Hawthorn Pharmaceuticals, which are an excellent combination with Pernix and are expected to provide strong growth for the Company in the future.”

Earnings before interest, taxes, depreciation and amortization (EBITDA, a non-GAAP measure) was $0.2 million for the third quarter of 2012, compared to EBITDA of $3.5 million for the third quarter of 2011. See the table at the end of this press release for a reconciliation of net income to EBITDA and adjusted EBITDA. The third quarter 2012, as compared to the third quarter 2011, was impacted by certain operating activities initiated in recent months including (i) an operating loss of approximately $513,000 from Great Southern Laboratories of which the majority was incurred in the acquisition month of July 2012, (ii) an operating loss on the Omeclamox-Pak product of approximately $400,000, (iii) the expenses incurred in the development of the Company’s OTC cough products utilizing the recently licensed cough intellectual property of approximately $107,000, and (iv) the expenses incurred pursuant to the Company’s previously announced pediatric prescription development program of approximately $105,000, along with an increase in stock compensation expense primarily related to a restricted stock issuance in March 2012 of approximately $321,000. In total, these investments in new products, acquisitions, development and personnel impacted EBITDA by approximately $1.5 million for the quarter.

Selling, general and administrative (SG&A) expenses in the third quarter of 2012 increased by approximately $4.3 to $9.8 million, compared to $5.5 million for the third quarter of 2011. The increase was primarily due to hiring and training of the Company’s new gastroenterology sales force, expenses associated with the launch of Omeclamox-Pak®, an increase in stock compensation expense, and acquisition and operating expenses related to Great Southern Laboratories.

Depreciation and amortization expense was $ 0.9 million for the third quarter of 2012, compared to $0.6 million for the third quarter of 2011. The Company recognized an income tax benefit of $0.4 million for the third quarter of 2012, compared to income tax expense of $0.9 million in the third quarter of 2011.

For the nine months ended September 30, 2012, net revenues increased 10% to $43.1 million, compared to $39.2 million for the prior year period. Total net revenues consisted of 60% branded products, 35% generic products, and 5% manufacturing revenues for the first nine months of 2012.

The net loss for the nine months ended September 30, 2012 was approximately $(10,911), or $0.00 per basic and diluted share, compared to net income of approximately $4.5 million, or $0.19 per basic and diluted share, for the prior year period.

EBITDA was $2.2 million for the nine months ended September 30, 2012, compared to EBITDA of $8.8 million for the prior year period. See the table at the end of this press release for a reconciliation of net income to EBITDA and adjusted EBITDA. The nine months ended September 30, 2012, as compared to the same period in 2011, was impacted by certain operating activities initiated in recent months including (i) an operating loss of approximately $513,000 from Great Southern Laboratories (ii) an operating loss on the Omeclamox-Pak product of approximately $1,450,000, (iii) the expenses incurred in the development of the Company’s OTC cough products utilizing the recently licensed cough intellectual property of approximately $337,000, and (iv) the expenses incurred pursuant to the Company’s previously announced pediatric prescription development program of approximately $137,000, along with an increase in stock compensation expense primarily related to a restricted stock issuance in March 2012 and stock option issuances after September 30, 2011 of approximately $1,029,000. In total, these investments in new products, product development, acquisitions and personnel impacted EBITDA by approximately $3.5 million.

SG&A expenses in the nine months ended September 30, 2012 increased by approximately $8.7 million to $24.3 million, compared to $15.6 million for the prior year period. As previously stated, the increase was primarily due to hiring and training of the Company’s new gastroenterology sales force, pre-launch expenses associated with Omeclamox-Pak®, an increase in stock compensation expense and acquisition and operating expenses related to Great Southern Laboratories.

Depreciation and amortization expense was $2.3 million for the nine months ended September 30, 2012, compared to $1.7 million for the prior year period. The Company recognized an income tax benefit of $0.2 million for the nine months ended September 30, 2012, compared to an income tax expense of $2.5 million in the prior year period.

Completed the Acquisition of Great Southern Laboratories

On July 2, 2012, Pernix completed its acquisition of the business assets of Great Southern Laboratories (“GSL”), a pharmaceutical contract manufacturing company located in Houston, Texas. The Company closed on the related real estate on August 30, 2012. Upon the final closing, the Company paid an aggregate of approximately $4.9 million, and assumed certain liabilities for substantially all of GSL’s assets including the land and buildings in which GSL operates. GSL has an established manufacturing facility with an existing base of customers in the pharmaceutical industry, which is expected to provide the Company with additional income and potential cost savings. The Company acquired the GSL assets through a wholly-owned subsidiary, Pernix Manufacturing, LLC, and continues to operate the business under the name Great Southern Laboratories.

Financial Position and Guidance

As of September 30, 2012, the Company had $37.0 million of cash and cash equivalents.

The Company expects the combined revenues of Pernix, with the addition of Cypress and Hawthorn to be in the range of $135-$145 million for the full year 2013. The Company is not issuing guidance for the full year 2012.

Conference Call Information

Management will host a conference call today at 9:00 a.m. EST to discuss its financial results for the third quarter and nine months ended September 30, 2012. The conference call will feature remarks from Cooper Collins, President and Chief Executive Officer, and David Becker, Chief Financial Officer. To participate in the live conference call, please dial (888) 364-3109 (U.S.) or (719) 325-2432 (International), and provide passcode 9218466. A live webcast of the call will also be available on the investor relations section of the Company’s website, www.pernixtx.com. Please allow extra time prior to the webcast to register and download and install any necessary audio software.

A replay of the call will be available through November 21, 2012. To access the replay, please dial (888) 203-1112 (U.S.) or (719) 457-0820 (International), and provide passcode 9218466. 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 is a specialty pharmaceutical company primarily focused on the sales, marketing, manufacturing and development of branded, generic and OTC pharmaceutical products. The Company manages a portfolio of branded and generic products. The Company’s branded products for the pediatrics market 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 treatments for cough and cold (BROVEX®, ALDEX® and PEDIATEX®). The Company’s branded products for gastroenterology include OMECLAMOX-PAK®, a 10-day treatment for H. pylori infection and duodenal ulcer disease, and REZYST™, a probiotic blend to promote dietary management. The Company promotes its branded pediatric and gastroenterology products through its sales force. Pernix markets its generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals. The Company’s wholly-owned subsidiary, Pernix Manufacturing, LLC, doing business as Great Southern Laboratories, manufactures and packages products for the pharmaceutical industry in a wide range of dosage-forms. A product candidate utilizing cough-related intellectual property is in development for the U.S. OTC market. Founded in 1996, the Company is based in The Woodlands, TX.

Additional information about Pernix is available on the Company’s website located at www.pernixtx.com.

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

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Company’s Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

   

PERNIX THERAPEUTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

September 30,
2012

December 31,
2011

(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 37,037,057 $ 34,551,180
Accounts receivable, net 20,786,923 20,601,360
Inventory, net 6,981,146 6,261,162
Prepaid expenses and other current assets 2,319,860 2,144,203
Prepaid taxes 1,713,675

Deferred income tax assets   5,168,000     4,552,000  
Total current assets 74,006,661 68,109,905
Property and equipment, net 6,961,435 911,948
Other assets:
Investments 6,355,262 4,451,831
Intangible assets, net 24,062,367 8,876,504
Other long-term assets   193,783     213,783  
Total assets $ 112,119,508   $ 82,563,971  
 
LIABILITIES
Current liabilities:
Accounts payable $ 5,915,601 $ 2,987,913
Accrued personnel expense 1,691,677 2,044,121
Accrued allowances 14,887,900 17,006,409
Income taxes payable

585,931
Other accrued expenses 3,107,302 1,565,918
Contracts payable 1,750,000 1,290,000
Debt – short term 248,946

Line of Credit  

    6,000,000  
Total current liabilities 27,601,426 31,480,292
Long-term liabilities
Contracts payable

600,000
Debt – long term 1,439,845
Deferred income taxes   4,465,000     860,000  
Total liabilities   33,506,271     32,940,292  
Commitments and contingencies
STOCKHOLDERS' EQUITY
Common stock, $.01 par value, 90,000,000 shares authorized, 31,143,639 and 27,820,004 issued, 29,070,829 and 25,749,137 outstanding at September 30, 2012 and December 31, 2011, respectively 290,708 257,491
Treasury stock, at cost (2,072,810 and 2,070,867 shares held at September 30, 2012 and December 31, 2011, respectively) (3,772,410 ) (3,751,890 )
Additional paid-in capital 56,886,190 30,185,292
Retained earnings 21,832,507 21,843,418
Accumulated other comprehensive income   3,376,242     1,089,368  
Total stockholders' equity   78,613,237     49,623,679  
Total liabilities and stockholders' equity $ 112,119,508   $ 82,563,971  
 
   

PERNIX THERAPEUTICS HOLDINGS, INC.

CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME

 
Three Months Ended September 30, Nine Months Ended September 30,
2012   2011 2012   2011
Net sales $ 18,134,158 $ 17,064,196 $ 43,115,517 $ 39,203,944
Costs and expenses:
Cost of product sales 7,759,761 7,684,233 15,861,461 13,069,161
Selling, general and administrative expenses 9,837,217 5,542,274 24,302,513 15,555,478
Research and development expense 332,971 147,138 511,694 717,802

Loss from the operations of the joint venture with SEEK

100,614 240,195 691,865
Royalties expense, net

32,461

377,273
Depreciation and amortization expense   885,982     603,528     2,320,589     1,690,827  
 
Total costs and expenses   18,815,931     14,110,248     43,236,452     32,102,406  
 
Income from operations   (681,773 )   2,953,948     (120,935 )   7,101,538  
 
Other income (expense):
Interest expense, net   7,431     (37,300 )   (59,976 )   (129,964 )
Total other income, net   7,431     (37,300 )   (59,976 )   (129,964 )
 
Income (loss) before income taxes (674,342 ) 2,916,648 (180,911 ) 6,971,574
Income tax provision (benefit)   (404,000 )   922,000     (170,000 )   2,500,000  
 
Net income (loss) $ (270,342 ) $ 1,994,648 $ (10,911 ) $ 4,471,574
Unrealized gain on securities, net of income tax 808,374

2,286,874

Comprehensive income $ 538,032 1,994,648 2,275,963 4,471,574
 
Net income (loss) per share, basic $ (0.01 ) $ 0.08   $ 0.00   $ 0.19  
Net income (loss) per share, diluted $ (0.01 ) $ 0.08   $ 0.00   $ 0.19  
 
Weighted-average common shares, basic   29,069,119     24,841,554     27,765,275     23,401,910  
 
Weighted-average common shares, diluted   29,069,119     25,147,191     27,765,275     23,737,231  
 

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. Adjusted EBITDA further eliminates the effect of stock-based compensation. EBITDA and adjusted EBITDA should not be considered in isolation from or as a substitute for net income.

 
PERNIX THERAPEUTICS HOLDINGS, INC.
EBITDA Reconciliation Table
(Unaudited)
 
  Three Months Ended Sept. 30,   Nine Months Ended Sept. 30,
2012   2011 2012   2011
GAAP Net Income (loss) $ (270,342 ) $ 1,994,648 $ (10,911 ) $ 4,471,574
Plus:
Income tax expense (benefit) $ (404,000 ) 922,000 (170,000 ) 2,500,000
Depreciation and amortization 885,982 603,528 2,320,589 1,690,827
Interest expense, net   (7,431 )   37,300   59,976     129,964
EBITDA $ 204,209   $ 3,557,476 $ 2,199,654   $ 8,792,365
 
Adjustments to EBITDA:
Stock-based compensation   678,149     357,372   1,901,568     872,269
Adjusted EBITDA $ 882,358   $ 3,914,848 $ 4,101,222   $ 9,664,634
 

Contacts

Pernix Therapeutics Holdings, Inc.
Joseph T. Schepers, 800-793-2145 ext. 3002
Director, Investor Relations
jschepers@pernixtx.com

Contacts

Pernix Therapeutics Holdings, Inc.
Joseph T. Schepers, 800-793-2145 ext. 3002
Director, Investor Relations
jschepers@pernixtx.com