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PTX > SEC Filings for PTX > Form 10-Q on 14-Nov-2012All Recent SEC Filings

Show all filings for PERNIX THERAPEUTICS HOLDINGS, INC.

Form 10-Q for PERNIX THERAPEUTICS HOLDINGS, INC.


14-Nov-2012

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion is designed to provide a better understanding of our unaudited consolidated financial statements, including a brief discussion of our business and products, key factors that impact our performance and a summary of our operating results. You should read the following Management's Discussion and Analysis of Financial Condition and Results of Operations together with our unaudited condensed consolidated financial statements and the related notes included in "Part I-Item 1. Financial Statements" of this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2011. In addition to historical information, the following discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results could differ materially from those anticipated by the forward-looking statements due to important factors including, but not limited to, those set forth under "Part I-Item1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2011.

Executive Overview

Strategy

Pernix Therapeutics Holdings, Inc. ("Pernix" or the "Company") is a specialty pharmaceutical company focused on the sales, marketing, manufacturing and development of branded, generic and over-the-counter ("OTC") pharmaceutical products for pediatric and adult indications in a variety of therapeutic areas. We expect to continue to execute our growth strategy which includes the horizontal integration of our branded prescription, generic and OTC businesses. We manage a portfolio of branded and generic products, as well as a non-codeine antitussive drug in development. Our 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 prescription treatments for cough and cold (BROVEX®, ALDEX® and PEDIATEX®). Our 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. We promote our branded pediatric and gastroenterology products through our sales force. We market our generic products through our wholly-owned subsidiary, Macoven Pharmaceuticals.

On November 13, 2012, the Company entered into a definitive agreement to acquire Cypress Pharmaceuticals, Inc. ("Cypress"), a privately-owned generic pharmaceutical company, and Hawthorne Pharmaceuticals, Inc. ("Hawthorne"), a privately-owned branded pharmaceutical company. Under the agreement, Pernix could pay up to $101 million, which includes up-front payments of $68.5 million in cash and $12.5 million in equity, $10 million payable in cash in December 2013, and an additional $10 million in milestone payments payable in cash and equity. The Company has received a commitment for a $60 million credit facility, subject to certain conditions. MidCap Financial will serve as Sole Bookrunner, Administrative Agent and Joint Lead Arranger for the credit facility. Cypress and Hawthorne, founded in 1993, are headquartered in Madison, MS and have 170 employees, including 115 sales reps. Hawthorne offers a wide array of branded pharmaceutical products, including allergy, respiratory, iron deficiency, nephrology, and pain management. Cypress offers a broad range of generic pharmaceutical products in the areas of cough and cold, nutritional supplements, analgesics, urinary tract, women's health, pre-natal vitamins, and dental health.

On July 2, 2012, we completed our acquisition of the business assets of Great Southern Laboratories ("GSL"), a pharmaceutical contract manufacturing company located in Houston, Texas. We closed on the related real estate on August 30, 2012. Upon the final closing, we paid an aggregate of approximately $4.6 million, and assumed certain liabilities totaling approximately $5.5 million, 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 us with additional income and potential cost savings. We acquired the GSL assets through a wholly-owned subsidiary, Pernix Manufacturing, LLC, and continues to operate the business under the name Great Southern Laboratories.

Pernix is the surviving corporation of a 2010 merger between Pernix Therapeutics, Inc., or PTI, and Golf Trust of America, Inc., or GTA. The words "we," "us" or "our" refers to Pernix and its consolidated subsidiaries, except where the context otherwise requires.

Pernix was incorporated in November 1996 and is headquartered in The Woodlands, Texas and employs approximately 166 people full-time, 58 of which are employed at Great Southern Laboratories which Pernix acquired on July 2, 2012.

Our business strategy is to:

? promote products through our sales and marketing organization of approximately 74 sales representatives, primarily in highly populated states, targeting pediatric and high-prescribing physicians;

? develop and launch generic and authorized generic products through Macoven, our wholly-owned subsidiary;

? launch new line extensions and new formulations of our currently marketed products;


? maximize the value of our non-codeine antitussive drug in development;

? continue to diversify and expand our product portfolio through acquisitions, co-promotions and in-licensing agreements;

? leverage our business model by expanding into additional therapeutic areas. For example, in May 2012, we established a sales force of approximately 30 representatives, consisting of new and existing representatives, dedicated to gastroenterology following our entry into the license agreement described below;

? integrate and maximize the value of our recently acquired manufacturing assets and facility, Great Southern Laboratories; and

? adapt quickly to a rapidly changing pharmaceutical environment, and operate as a quick, nimble, and agile company.

We believe that if we continue to implement this strategy successfully, we can deliver consistent long-term revenue and earnings growth.

Acquisitions and License Agreements, Co-Promotions and Collaborations

We have and continue to grow our business through the use of acquisitions, license agreements, co-promotions and collaborations. We enter into acquisition, license and co-promotion agreements to acquire, develop, commercialize and market products and product candidates. In certain of these agreements, we market the products of others and remit a specified profit share to them. In certain other agreements, the contracted third party under the agreement markets products to which we have rights and remits a specified profit share to us. Collaborative agreements often include research and development efforts and/or capital funding requirements of the parties necessary to bring a product candidate to market. License, co-promotion and collaboration agreements may require royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the product, as well as expense reimbursements or payments to third-party licensors.

Restructure of Natroba Agreement

See Note 10 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Acquisition of Pharmaceutical Manufacturing Company

See Note 6 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q. As noted above, we expect to utilize the manufacturing plant that we recently acquired to manufacture several of our products moving forward which we expect to result in a reduction in the cost of certain of our products.

Acquisition of New Product

See Note 7 to our Condensed Consolidated Financial Statements for the three and six months ended June 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.


Termination of Joint Venture

See Notes 5 and 7 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

License of Gastroenterology Product.

For discussion regarding the license we acquired related to Omeclamox-Pak®, see Note 7 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Collaborations

Development of Late-stage Pediatric Product. For discussion regarding a development agreement that we entered into with a private company for a prescription product for the pediatrics market, see Note 13 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Third Quarter 2012 Highlights

The following summarizes certain key financial measures as of, and for, the three months ended September 30, 2012:

? Cash and cash equivalents equaled $37.0 million as of September 30, 2012.

? Net revenues were approximately $18.1 million.

? Net loss before taxes was approximately $0.7 million.

Opportunities and Trends

There continue to be unmet patient needs in the pediatric area as well as other therapeutic areas. We believe that we can systematically focus our efforts on developing and acquiring products or acquiring the assets of other companies whose products or assets can meet these needs. We also believe that future growth will be realized in the execution of branded and generic development opportunities outside the pediatric area. We believe the combination of product development and acquisitions will enhance our growth opportunities. Additionally, we will continue to leverage our industry relationships to identify and take advantage of new product opportunities.

We are operating in challenging economic and industry environments. The challenges we face are compounded by the continued uncertainty around the impact of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, which we refer to collectively herein as Health Care Reform. Given this business climate, we will continue to focus on managing and deploying our available cash efficiently and strengthening our industry relationships in order to be well-positioned to identify and capitalize upon potential growth opportunities.


As we execute our strategy, we will monitor and evaluate success through the following measures:

? Net product sales generated from our existing products;

? Revenues generated from co-promotion agreements;

? Revenues generated from our recently acquired manufacturing facility;

? Progress of our development pipeline (as discussed below); and

? Acquisition of products and product rights that align with our strategy and that offer potential for sustainable growth.

See Note 1 to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for our discussion of net proceeds received from our controlled equity offering in April 2012 that is expected to fund future acquisitions and for general corporate purposes.

Financial Operations Overview

The discussion in this section describes our income statement categories. For a discussion of our results of operations, see "Results of Operations" below.

Net Revenues

Pernix's net revenues consist of net product sales and revenue from co-promotion and other revenue sharing arrangements. Pernix recognizes product sales net of estimated allowances for product returns, price adjustments (customer rebates, service fees, chargebacks and other discounts), government program rebates (Medicaid, Medicare and other government sponsored programs) and prompt pay discounts. The primary factors that determine Pernix's net product sales are the level of demand for Pernix's products, unit sales prices, the applicable federal and supplemental government program rebates, contracted rebates, services fees, chargebacks and other discounts that Pernix may offer. In addition to our own product portfolio, we have entered into co-promotion agreements and other revenue sharing arrangements with various parties in return for a percentage of revenue on sales we generate or on sales they generate.


The following table sets forth a summary of Pernix's net revenues for the three and nine months ended September 30, 2012 and 2011:

                                              Three Months Ended           Nine Months Ended
                                                September 30,                September 30,
                                              2012         2011           2012         2011

Upper respiratory, allergy and
antibiotic products                        $    6,815     $  10,810     $  27,056     $  40,376
ENT                                               415             ?           415             ?
Gastroenterology                                1,987             ?         4,279             ?
Medical food products                             287           117           761           625
Dermatology products (including Natroba)        4,076         7,709         5,980         9,962
Other generic products                          6,790         4,398        19,129         5,947
Gross product sales                            20,370        23,034        57,620        56,910
Sales allowances                               (5,510 )      (6,785 )     (19,313 )     (21,408 )
Net product sales                              14,860        16,249        38,307        35,502
Manufacturing revenue                           2,094             ?         2,094             ?
Collaboration and other revenue                 1,180           815         2,715         3,702
Net Revenues                               $   18,134     $  17,064     $  43,116     $  39,204

Allowances for Prompt Pay Discounts, Product Returns, Price Adjustments, and
Medicaid Rebates

 The following table sets forth a summary of our allowances for product returns,
government rebate programs and price adjustments as of September 30,
2012.  Prompt pay discounts are recorded as a reduction of accounts receivable
and revenue and, therefore, are not included in the table below. The allowance
for prompt pay discounts as of September 30, 2012 and December 31, 2011 was
approximately $370,000 and $393,000, respectively.

                                                                            Government
                                                         Product             Program             Price
                                                         Returns             Rebates          Adjustments
                                                     (in thousands)       (in thousands)     (in thousands)
Balance at December 31, 2010                         $         4,313     $          4,432       $      1,744
Adjustments to provision for prior year sales                    498                1,137                300
Provision - current year sales                                 4,784                9,969             12,311
Payments and credits                                          (3,883 )             (9,695 )           (8,904 )
Balance at December 31, 2011                                   5,712                5,843              5,451
Assumed liability in product acquisition                           ?                  187                  ?
Adjustments to provision for prior year sales                    620                    ?                  ?
Provision - current year sales                                 3,677                4,101              9,716
Payments and credits                                          (5,366 )             (5,406 )           (9,648 )
Balance at September 30, 2012                        $         4,643     $          4,725       $      5,519


Product Returns. Consistent with industry practice, the Company offers contractual return rights that allow its customers to return the majority of its products within an 18-month period, commencing from six months prior to and up to twelve months subsequent to the product expiration date. The Company's products have a 24 to 36-month expiration period from the date of manufacture. The Company adjusts its estimate of product returns if it becomes aware of other factors that it believes could significantly impact its expected returns. These factors include its estimate of inventory levels of its products in the distribution channel, the remaining shelf life of the product, review of consumer consumption data as reported by external information management companies, actual and historical return rates for expired lots, the forecast of future sales of the product, competitive issues such as new product entrants and other known changes in sales trends. The Company estimated returns at 5% to 14% of sales of branded products during the third quarter of 2012. The Company is accruing 14% on launch sales of Omeclamox-Pak®. The Company estimated returns at 7% on sales of generic products on sales during the second and third quarters of 2012. The returns estimate on generic products was increased approximately 2% effective April 1, 2012 from prior periods due to the potential impact of changes in Medicaid coverage on certain products. Return estimates are based upon historical data and other facts and circumstances that may impact future expected returns to derive an average return percentage of our products. In connection with our new agreement with ParaPRO, we are working with them to revise the terms for the handling of any returns of Natroba. In the interim, returns will be handled as previously disclosed. The returns reserve may be adjusted as we accumulate sales history and returns experience on this portfolio of products. The Company reviews and adjusts these reserves quarterly. If estimates regarding product demand are inaccurate, if changes in the competitive environment affect demand for certain products, or if other unforeseen circumstances effect a product's salability, actual returns could differ and such differences could be material. For example, a 1% difference in our provision assumptions for the nine months ended September 30, 2012 would have affected pre-tax earnings by approximately $595,000.

Government Program Rebates . The liability for government program rebates is estimated based on historical and current rebate redemption and utilization rates contractually submitted by each state's program administrator and assumptions regarding future Medicaid utilization for each product sold. As we become aware of changing circumstances regarding the Medicaid and Medicare coverage of our products, we will continue to incorporate such changing circumstances into the estimates and assumptions that we use to calculate government program rebates. If our estimates and assumptions prove inaccurate, we may be subject to higher or lower government program rebates. For example, with respect to the provision for the nine months ended September 30, 2012, a 1% difference in the provision assumptions based on utilization would have effected pre-tax earnings by approximately $127,000 and a 1% difference in the provisions based on reimbursement rates would have affected pre-tax earnings by approximately $45,000.

Price Adjustments . Our estimates of price adjustments which include customer rebates, service fees, and chargebacks are based on our estimated mix of sales to various third-party payors who are entitled either contractually or statutorily to discounts from the listed prices of our products and contracted service fees with our wholesalers. In the event that the sales mix to third-party payors or the contract fees paid to the wholesalers are different from our estimates, we may be required to pay higher or lower total price adjustments than originally estimated. For example, for the nine months ended September 30, 2012, a 1% difference in the assumptions based on the applicable sales would have affected pre-tax earnings by approximately $946,000.

We, from time to time, offer certain promotional product-related incentives to our customers. These programs include sample cards to retail consumers, certain product incentives to pharmacy customers and other sales stocking allowances. For example, we have initiated coupon programs for certain of our promoted products whereby we offer a point-of-sale subsidy to retail consumers. We estimate our liabilities for these coupon programs based on redemption information provided by a third party claims processing organization. We account for the costs of these special promotional programs as a reduction of gross revenue when applicable products are sold to the wholesalers or other retailers. For the nine months ended September 30, 2012, a 1% difference in the assumption applied to coupon utilization would have affected pre-tax earnings by approximately $36,000.

Any price adjustments that are not contractual but that are offered at the time of sale are recorded as a reduction of revenue when the sales order is recorded. These adjustments are not accrued as they are offered on a non-recurring basis at the time of sale and are recorded as an expense at the time of the sale. These allowances may be offered at varying times throughout the year or may be associated with specific events such as a new product launch or to reintroduce a product. Approximately 15% of the provision relates to point-of-sale discounts to the wholesaler.


Prompt Payment Discounts. We typically require our customers to remit payments within the first 30 days for branded products (60 to 120 days for generics, depending on the customer and the products purchased). We offer wholesale distributors a prompt payment discount if they make payments within these deadlines. This discount is generally 2%, but may be higher in some instances due to product launches and/or industry expectations. Because our wholesale distributors typically take advantage of the prompt pay discount, we accrue 100% of the prompt pay discounts, based on the gross amount of each invoice, at the time of our original sale, and apply earned discounts at the time of payment. This allowance is recorded as a reduction of accounts receivable and revenue. We adjust the accrual periodically to reflect actual experience. Historically, these adjustments have not been material. We do not anticipate that future changes to our estimates of prompt payment discounts will have a material impact on our net revenue.

Cost of Product Sales

Our cost of product sales is primarily comprised of the costs of manufacturing and distributing Pernix's pharmaceutical products and samples and collaboration expense related to co-promotional agreements with third parties. In particular, cost of product sales includes third-party manufacturing, packaging and distribution costs and the cost of active pharmaceutical ingredients. Pernix partners with third parties to manufacture the majority of its products and product candidates. We expect to utilize Great Southern Laboratories, the manufacturing plant that we recently acquired, to manufacture several of our products moving forward which we expect to result in a reduction in the cost of certain of our products.

Most of our manufacturing arrangements are not subject to long-term agreements and generally may be terminated by either party without penalty at any time. Changes in the price of raw materials and manufacturing costs could adversely affect Pernix's gross margins on the sale of its products. Changes in Pernix's mix of products sold also affect its cost of product sales.

The cost of NATROBA is included in our cost of product sales from August 2011 (the month of launch). We pay wholesale average cost less a nominal discount when we purchase NATROBA inventory. Under the original agreement with ParaPRO, we received a contracted cost of goods rebate per unit when the product shipped to retailers in our specified territories. Under the renegotiated terms effective August 24, 2012, we receive a flat co-promotion fee on NATROBA per unit based on prescriptions in our specified territories. Because of the structure of the NATROBA agreement, we recognize significantly lower margins on sales of NATROBA as compared to the other products we market.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses consist primarily of salaries, benefits and commissions as well as public company costs, professional and consulting fees, sales data costs, insurance, and company overhead.

Research and Development Expenses

Research and development expenses consist of costs incurred in identifying, developing and testing products and product candidates. Pernix either expenses research and development costs as incurred or if Pernix pays manufacturers a prepaid research and development fee, Pernix will expense such fee ratably over the term of the development. Pernix believes that significant investment in research and development is important to its competitive position and may, in the future, increase its expenditures for research and development to realize the potential of the product candidates that it is developing or may develop.

Loss from the Operations of the Joint Venture

See Note 5, Investments, to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.


Other Income and Expenses

Depreciation Expense. Depreciation expense is recognized for our property and equipment, which depreciates over the estimated useful life of the asset using the straight-line method.

Amortization Expense. Amortization expense is recognized for certain of our intangible assets, consisting primarily of licensing and acquisition agreements, including but not limited to, the customer relationships acquired in the acquisition of GSL in July 2012, the license related to the non-codeine antitussive drug in development acquired in May 2012, the gastroenterology license acquired in February 2012, CEDAX in March 2010 and Macoven in September 2010, which are amortized over their estimated useful lives using the straight-line method. See Note 7, Intangible Assets, to our Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2012 and 2011 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Income Taxes. Deferred taxes are recognized for the tax consequences of "temporary differences" by applying enacted statutory tax rates applicable to . . .

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