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| PTX > SEC Filings for PTX > Form 10-Q on 14-Aug-2012 | All Recent SEC Filings |
14-Aug-2012
Quarterly Report
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 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.
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 the manufacturing assets and facility acquired from Great Southern Laboratories in June 2012; 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 12 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.
Acquisition of Pharmaceutical Manufacturing Company
See Note 12 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. 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.
Acquisition of New Product
See Note 12 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 4 and 5 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.
License of Gastroenterology Product.
For discussion regarding the license we acquired related to Omeclamox-Pak®, see Note 5 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.
Collaborations
Development of Late-stage Pediatric Product. In March 2012, we entered into a product development agreement with a private company for a prescription product for the pediatrics market. Under the terms of the agreement, Pernix obtained exclusive marketing rights to this late-stage development product in the United States, and Pernix will pay the costs related to the development of the product. Pernix expects to invest approximately $6 million over an estimated 36-month period for development and regulatory expenses related to this product candidate, and Pernix's development partner will manage the development program. Pernix and its development partner expect to commence pivotal phase III studies in the next 12 months.
Second Quarter 2012 Highlights
The following summarizes certain key financial measures as of, and for, the three months ended June 30, 2012:
? Cash and cash equivalents equaled $50.5 million as of June 30, 2012.
? Net revenues were approximately $10.5 million.
? Net (loss) income before taxes was approximately ($1.5) 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;
? 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 six months ended June 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.
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 six months ended June 30, 2012 and 2011:
Three Months Ended Six Months Ended
June 30, June 30,
2012 2011 2012 2011
Upper respiratory, allergy and
antibiotic products $ 8,688 $ 12,151 $ 20,242 $ 29,812
Gastroenterology 2,292 ? 2,292 ?
Medical food products 175 275 473 487
Dermatology products (including Natroba) 405 1,569 1,904 1,946
Other generic products 5,422 1,631 12,339 1,632
Collaboration and other revenue 1,037 1,721 1,534 2,887
Gross Revenues 18,019 17,347 38,784 36,764
Sales Allowances (7,520 ) (5,302 ) (13,803 ) (14,624 )
Net Revenues $ 10,499 $ 12,045 $ 24,981 $ 22,140
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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 June 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 June 30, 2012 and December 31, 2011 was approximately
$301,000 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
Adjustments to provision for prior year sales 500 ? ?
Provision - current year sales 2,331 3,087 7,106
Payments and credits (3,227 ) (4,509 ) (5,892 )
Balance at June 30, 2012 $ 5,316 $ 4,421 $ 6,665
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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 second quarter of 2012. The Company is accruing 14% on launch sales of Omeclamox-Pak® which may be adjusted in the future as actual historical returns data is accumulated. The Company estimated returns at 7% on sales of generic products on sales during the second quarter of 2012. The returns estimate on generic products was increased from prior periods due to 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. In addition to the accrual on sales during the three months ended June 30, 2012, the Company recorded an additional returns allowance of $500,000 as a result of the loss of Medicaid coverage on certain generic products. 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 six months ended June 30, 2012 would have affected pre-tax earnings by approximately $373,000.
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 three months ended June 30, 2012, a 1% difference in the provision assumptions based on utilization would have effected pre-tax earnings by approximately $89,000 and a 1% difference in the provisions based on reimbursement rates would have affected pre-tax earnings by approximately $33,000.
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 six months ended June 30, 2012, a 1% difference in the assumptions based on the applicable sales would have affected pre-tax earnings by approximately $601,000.
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. 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 13% 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 all 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 and then receive a contracted cost of goods rebate when the product ships to retailers in our specified territories, resulting in significantly lower margins on sales of NATROBA as compared to the other products we market. In connection with our new agreement with ParaPRO, we are working with them regarding the cost we pay for Natroba. In the interim, the cost and related rebate we receive will continue to be pursuant to the original supply and distribution agreement
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 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 4, Investment in Joint Venture, 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.
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 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 5, Intangible Assets, 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.
Income Taxes. Deferred taxes are recognized for the tax consequences of "temporary differences" by applying enacted statutory tax rates applicable to future years to the difference between the financial statement carrying amounts and the tax bases of existing assets and liabilities. The effect on deferred taxes for a change in tax rates is recognized in income in the period that includes the enactment date. Pernix will recognize future tax benefits to the extent that realization of such benefits is more likely than not.
Critical Accounting Estimates
For information regarding our critical accounting policies and estimates please refer to "Management's Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Estimates" contained in our annual report on Form 10-K for the year ended December 31, 2011 and Note 2 to our condensed consolidated financial statements contained therein. There have been no material changes to the critical accounting policies previously disclosed in that report.
Results of Operations
Comparison of the Three Months Ended June 30, 2012 and 2011
Net Revenues. Net revenues were approximately $10,499,000 and $12,045,000 for the three months ended June 30, 2012 and 2011, respectively, a decrease of approximately $1,546,000 or 12.8%. The decrease in net revenues during the three months ended June 30, 2012 was primarily due to an increase in deductions from revenue of approximately $2,218,000 and a decrease in co-promotion revenue of approximately $685,000 offset by an increase in gross product sales of approximately $1,357,000. The increase in gross product sales was attributed to gross sales from the launch of Omeclamox-Pak® of approximately $2,168,000. The increase in gross revenue was offset by an increase in deductions from gross product sales revenue (including allowances for returns, government program rebates and price adjustments) of approximately $2,218,000, or 41.8%, due primarily to an increase in the allowance for coupon redemptions and chargebacks related to the launch of Omeclamox-Pak® in addition to an increase in the allowances for sales discounts, retailer rebates,vendor fees and product sales returns.
Cost of Product Sales. Cost of product sales was approximately $3,411,000 and $3,429,000 for the three months ended June 30, 2012 and 2011, respectively, a decrease of approximately $18,000, or 0.5%. The decrease in cost of product . . .
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