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| PTX > SEC Filings for PTX > Form 10-Q on 15-May-2012 | All Recent SEC Filings |
15-May-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 condensed 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 and generic 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 over-the-counter ("OTC") businesses. We manage a portfolio of branded and generic products and theobromine, a non-codeine, cough suppressant product candidate 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®). We also market REZYST IM™, a proprietary probiotic blend to promote dietary management. The Company promotes its branded products through an established U.S. sales force. Pernix also markets generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals.
Pernix was incorporated in November 1996 and is headquartered in The Woodlands, Texas and employs approximately 85 people full-time.
Our business strategy is to:
? Promote products through our sales and marketing organization of approximately 55 sales representatives, plus our new gastro sales force of approximately 25 sales repesentatives, 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 exclusive rights to the joint venture intellectual property assets in the United States and Canada.
? 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. We are currently establishing 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.
? 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.
Certain products in our portfolio are marketed without a United States Food and Drug Administration ("FDA") approved marketing application because we consider them to be identical, related or similar to products that have existed in the market without an FDA-approved marketing application, and which were thought not to require pre-market approval, or which were approved only on the basis of safety, at the time they entered the marketplace, subject to FDA enforcement policies established with the FDA's Drug Efficacy Study Implementation, or DESI, program. On March 2, 2011, the FDA announced the removal of certain unapproved prescription cough, cold and allergy products from the U.S. market. The FDA announcement has not resulted in a material adverse impact on our results of operations or financial condition, nor do we expect it to in future periods.
Acquisitions and License Agreements, Co-Promotions and Collaborations
On May 14, 2012, we acquired the exclusive rights from SEEK, our joint venture partner, to commercialize and market products utilizing the intellectual property (IP) in the areas of cough, cold, sinus and allergy in the United States and Canada. SEEK will retain exclusive rights to commercialize and develop Theobromine outside the United States and Canada in connection with the termination of our joint venture with SEEK. SEEK will retain exclusive rights to commercialize and develop the commercial property outside the United States and Canada. Under the terms of the agreement, we paid SEEK $5 million in connection with the termination of our joint venture with SEEK, and will pay royalties to SEEK on sales of products utilizing the joint venture IP in the United States and Canada. We will also receive royalties from SEEK product sales outside of the United States and Canada. As a result, we will no longer share in the development costs outside the United States and Canada.
In January 2012, we entered into a license and supply agreement with a private company for Omeclamox®, a new FDA-approved prescription product to treat gastroenterology disease. Under the terms of the agreement, we obtained exclusive marketing rights to this product in the United States. We paid an up-front license fee of $2.0 million and expect to pay an additional fee of $2.0 million upon commercial launch of Omeclamox®. In addition to these license fees, the agreement calls for us to pay royalties and milestone payments based on the sales of the product. Pernix is currently establishing a gastroenterology sales force and plans to launch Omeclamox-Pak® in the summer of 2012. Omeclamox-Pak® is a triple combination medication taken orally to treat Helicobacter pylori (H. pylori) infection and eradicate duodenal ulcer disease in adults.
Omeclamox-Pak® is a ten-day therapy of omeprazole delayed-release capsules (20 mg), clarithromycin tablets (500 mg) and amoxicillin capsules (500 mg) for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adult patients. The product is co-packaged in twice-daily patient compliance packs and was approved by the U.S. Food and Drug Administration (FDA) in 2011.
H. pylori are a bacterium acquired largely by people living in developing countries. Researchers suspect the bacteria are passed through contact with human saliva and waste, or contaminated food and water. If H. pylori is left untreated, it can damage the stomach and small intestine wall causing peptic ulcer disease, specifically duodenal ulcers. Symptoms of H. pylori-induced duodenal ulcers generally surface in adults and may include burning pain in the abdomen, nausea, vomiting, and bloating and weight loss. According to the National Institutes of Health, approximately 20 percent of people under 40 years old and half of adults over 60 years of age are infected.
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.
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.
First Quarter 2012 Highlights
The following summarizes certain key financial measures as of, and for, the three months ended March 31, 2012:
? Cash and cash equivalents totaled $39.2 million as of March 31, 2012.
? Net revenues were approximately $14.5 million and $10.1 million for the three months ended March 31, 2012 and 2011, respectively.
? Net income before taxes was approximately $ 2.0 million and $1.7 million for the three months ended March 31, 2012 and 2011, respectively. Net income was approximately $1.2 million and $1.0 million for the three months ended March 31, 2012 and 2011, respectively.
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 acquisition 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;
? 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 Notes 1 and 12 to our Condensed Consolidated Financial Statements for the three months ended March 31, 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 registered direct offering in July 2011 and 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, and 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 months ended March 31, 2012 and 2011:
Three Months Ended
March 31,
2012 2011
Upper respiratory, allergy and antibiotic products $ 11,552 $ 17,662
Dietary supplements and medical food products 3,031 212
Dermatology products (including Natroba) 1,500 378
Other generic products 4,088 -
Co-promotion and other revenue 594 1,166
Gross Revenues 20,765 19,418
Sales Allowances (6,283 ) (9,323 )
Net Revenues $ 14,482 $ 10,095
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During the three months ended March 31, 2012, Macoven's sales of generic products accounted for approximately 39% of total gross product sales revenue.
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 March 31, 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 March 31, 2012 and December 31, 2011 was approximately
$340,000 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
Provision - current year sales 1,077 1,728 3,051
Payments and credits (1,924 ) (2,708 ) (3,325 )
Balance at March 31, 2012 $ 4,865 $ 4,863 $ 5,177
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Product Returns. Consistent with industry practice, we offer contractual return rights that allow our customers to return the majority of our products within an 18-month period, from six months prior to and up to twelve months subsequent to the expiration date of our products. Most of our products have a 24 to 36-month shelf life from the date of manufacture. We adjust our estimate of product returns if we become aware of other factors that we believe could significantly impact our expected returns. These factors include our estimate of inventory levels of our 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 and competitive issues such as new product entrants and other known changes in sales trends. We estimated returns at 5% to 10% of sales of branded products (currently 7% on sales of NATROBA) during the first quarter of 2012 and 5% to 7% for generic products based upon historical data and other facts and circumstances that may impact future expected returns to derive the average return percentages of our products. Under our co-promotion agreement with ParaPRO, certain returns of Natroba sold within the first year of launch will be reimbursed by ParaPRO up to 65%. We review the reserve quarterly and adjust it accordingly. 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 three months ended March 31, 2012 would have affected pre-tax earnings by approximately $203,000.
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 March 31, 2012, a 1% difference in the provision assumptions based on utilization would have effected pre-tax earnings by approximately $40,000 and a 1% difference in the provisions based on reimbursement rates would have affected pre-tax earnings by approximately $20,000.
Price Adjustments. Our estimates of price adjustments which include customer rebates, service fees, chargebacks and other discounts 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 three months ended March 31, 2012, a 1% difference in the assumptions based on the applicable sales would have affected pre-tax earnings by approximately $333,000.
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 20% 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 certain pharmaceutical ingredients. Pernix partners with third parties to manufacture all of its products and product candidates.
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.
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, including products utilizing our IP acquired in connection with the termination of our joint venture with SEEK in the areas of cough, cold, sinus and allergy in the United States and Canada. See Note 12, Subsequent Events, to our Condensed Consolidated Financial Statements for the three months ended March 31, 2012 and 2011 contained in Part I, Item I of this Quarterly Report on From 10-Q for a discussion of our acquisition of the exclusive rights to the theobromine intellectual property in the United States and Canada.
Loss from the Operations of the Joint Venture
See Note 4, Investment in Joint Venture, to our Condensed Consolidated Financial Statements for the three months ended March 31, 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 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.
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 March 31, 2012 and 2011
Net Revenues. Net revenues were approximately $14,482,000 and $10,095,000 for the three months ended March 31, 2012 and 2011, respectively, an increase of approximately $4,387,000, or 43.5%. The increase in net revenues during the three months ended March 31, 2012 was due to a combination of reductions in Medicaid rebate expense of approximately $3,400,000 and in chargebacks of approximately $519,000 and an increase in gross product sales of approximately $2,016,000 offset by a decrease in collaboration and other revenue of approximately $668,000 and an increase in other gross-to-net deductions such as . . .
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