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Summary of Significant Accounting Policies
12 Months Ended
Dec. 31, 2012
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

  • Basis of Presentation and Principles of Consolidation

        The accompanying consolidated financial statements of United Therapeutics and its wholly owned subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). All intercompany balances and transactions have been eliminated in consolidation. On March 31, 2011, we sold our wholly-owned telemedicine subsidiary, Medicomp, Inc. (Medicomp). Accordingly, the operating results of Medicomp for each of the two years in the period ended December 31, 2011 have been reclassified and presented within discontinued operations on our consolidated statements of operations. This change in presentation had no impact on net income as previously reported. We did not recast our consolidated statements of cash flows for the years ended December 31, 2011 and 2010 to reflect the classification of Medicomp as a discontinued operation as the impact is not significant to those statements (refer to Note 17—Sale of Medicomp, Inc.).

  • Use of Estimates

        The preparation of the consolidated financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. We base our estimates on assumptions regarding historical experience, currently available information and anticipated developments that we believe are reasonable and appropriate. However, because the use of estimates involves an inherent degree of uncertainty, actual results could differ from those estimates. Our significant accounting policies that require use of subjective and/or complex judgment and estimates impact the following financial statement areas: revenue recognition, share-based compensation, marketable investments, fair value measurements (including those relating to our acquisitions), income taxes, goodwill and other intangible assets, and obligations related to our Supplemental Executive Retirement Plan.

  • Fair Value of Financial Instruments

        The carrying amounts of cash and cash equivalents, accounts receivables, accounts payable, and accrued expenses approximate fair value because of their short maturities. The fair values of our marketable investments and 1.0% Convertible Senior Notes due September 15, 2016 (2016 Convertible Notes) are reported in Notes 4—Marketable Investments and 5—Fair Value Measurements, respectively. The recorded value of our $70.0 million mortgage loan approximates its fair value as it bears a variable rate of interest that we believe approximates the market rate of interest for debt with similar credit risk profiles, terms and maturities. Refer to Note 8—Debt—Mortgage Financing—Wells Fargo.

  • Fair Value Measurements

        Fair value is a market-based measurement, not an entity-specific measurement. The objective of a fair value measurement is to estimate the price to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date under current market conditions. Such transactions to sell an asset or transfer a liability are assumed to occur in the principal market for that asset or liability, or in the absence of the principal market, the most advantageous market for the asset or liability.

        Assets and liabilities subject to fair value measurement disclosures are required to be classified according to a three-level fair value hierarchy with respect to the inputs (or assumptions) used to determine fair value. Observable inputs such as unadjusted quoted market prices for identical assets or liabilities are given the highest priority within the hierarchy (Level 1). When observable inputs are unavailable, the use of unobservable inputs is permitted—i.e., inputs that a reporting entity believes market participants would use in pricing that are developed based on the best information available. Unobservable inputs are given the lowest priority within the hierarchy (Level 3). The level in which an asset or liability is disclosed within the fair value hierarchy is based on the lowest level input that is significant to the related fair value measurement in its entirety. The guidance under the fair value measurement framework applies to other existing accounting guidance in the Financial Accounting Standard Board (FASB) codification that requires or permits fair value measurements. Refer to related disclosures at Note 5—Fair Value Measurements to these consolidated financial statements.

  • Cash Equivalents

        Cash equivalents consist of highly liquid investments with maturities of three months or less from the date of acquisition and include money market funds, commercial paper, and certificates of deposit.

  • Marketable Investments

        Substantially all of our marketable investments are debt securities that we classify as held-to-maturity because of our positive intent and ability to hold the securities until maturity. Held-to-maturity securities are classified as either current or non-current assets on our consolidated balance sheets based on their contractual maturity dates and recorded at amortized cost, adjusted for the amortization of discounts or premiums. Related discounts and premiums are amortized over the term of these securities as an adjustment to yield using the effective interest method.

        We monitor our investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of an investment exceeds its fair value and the decline in value is determined to be other-than-temporary, we record an impairment charge within earnings attributable to the estimated credit loss. In determining whether a decline in the value of an investment is other-than-temporary, we evaluate currently available factors that may include, among others: (1) general market conditions, (2) the duration and extent to which fair value has been less than the carrying value, (3) the investment issuer's financial condition and business outlook, and (4) our assessment as to whether it is more likely than not that we will be required to sell a security prior to recovery of its amortized cost basis.

  • Trade Receivables

        Trade receivables consist of short-term amounts due from customers and are stated at the amount we expect to collect. We establish an allowance for doubtful accounts, if any, based on our assessment of the collectability of specific customer accounts.

  • Inventories

        Inventories are stated at the lower of cost (first-in, first-out method) or market (current replacement cost) and consist of the following, net of reserves (in thousands):

 
  December 31,  
 
  2012   2011  

Raw materials

  $ 13,603   $ 9,171  

Work in progress

    11,708     14,222  

Finished goods

    11,943     22,588  
           

Total inventories(1)

  $ 37,254   $ 45,981  
           

(1)
During the year ended December 31, 2012, we increased our reserves for obsolescence by $8.9 million which represents the cost of the nebulizer incorporated into our Tyvaso Inhalation System expected to be rendered obsolete based on the pending commercial release in 2013 of our improved nebulizer, the TD-100.
  • Goodwill and Other Intangible Assets

        The carrying amount of goodwill is not amortized but is subject to annual impairment testing. We evaluate goodwill for impairment during the fourth quarter of each year, or more frequently if impairment indicators exist. In determining whether goodwill is impaired, we compare the estimated fair value of the reporting unit to which goodwill has been assigned to its carrying value (Step 1 of the goodwill impairment test). If the carrying amount of a reporting unit exceeds its fair value, then the amount of an impairment loss, if any, is measured as the excess of the carrying amount of goodwill over its implied fair value (Step 2 of the goodwill impairment test).

        In February 2011, we entered into an agreement to sell our wholly-owned subsidiary, Medicomp, Inc. (Medicomp). Based on the estimated fair value of the purchase consideration, we wrote off the carrying value of Medicomp's goodwill at December 31, 2010 and recognized a related impairment charge of $6.2 million, which has been included within the results of discontinued operations on our consolidated statement of operations for the year ended December 31, 2010.

        Intangible assets subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an intangible asset may not be recoverable. Impairment losses are measured and recognized to the extent the carrying value of such assets exceed their fair values.

        Goodwill and other intangible assets comprise the following (in thousands):

 
  As of December 31, 2012   As of December 31, 2011  
 
  Gross   Accumulated
Amortization
  Net   Gross   Accumulated
Amortization
  Net  

Goodwill(1)

  $ 10,530   $   $ 10,530   $ 8,123   $   $ 8,123  

Other intangible assets(1):

                                     

Technology, patents and tradenames

    4,859     (2,825 )   2,034     4,766     (1,999 )   2,767  

Customer relationships and non-compete agreements

    4,749     (2,232 )   2,517     4,653     (1,658 )   2,995  

Contract-based(2)

    2,020     (693 )   1,327     8,350     (148 )   8,202  
                           

Total

  $ 22,158   $ (5,750 ) $ 16,408   $ 25,892   $ (3,805 ) $ 22,087  
                           

(1)
Includes foreign currency translation adjustments.

(2)
Refer to Note 16—Acquisitions—Revivicor, Inc.

        We are amortizing other intangible assets over an estimated weighted average life of 6.5 years. Related amortization expense for the years ended December 31, 2012, 2011 and 2010, was $2.1 million, $1.7 million and $1.6 million, respectively. As of December 31, 2012, aggregate amortization expense relating to intangible assets for each of the five succeeding years and thereafter is estimated as follows (in thousands):

Year Ended December 31,
   
 

2013

  $ 1,957  

2014

    1,540  

2015

    1,185  

2016

    656  

2017

    450  

Thereafter

    90  
       

 

  $ 5,878  
       
  • Property, Plant and Equipment

        Property, plant and equipment is recorded at cost and depreciated over its estimated useful life using the straight-line method. The estimated useful lives of property, plant and equipment by major category are as follows:

Buildings

  25-39 Years

Building improvements

  10-39 Years

Furniture, equipment and vehicles

  3-15 Years

Leasehold improvements

  Remaining lease term, or the estimated useful life of the improvement, whichever is shorter

        Property, plant and equipment consists of the following (in thousands):

 
  As of December 31,  
 
  2012   2011  

Land

  $ 38,104   $ 21,723  

Buildings, building improvements and leasehold improvements

    393,174     249,289  

Buildings under construction

    4,302     72,511  

Furniture, equipment and vehicles

    96,096     75,801  
           

 

    531,676     419,324  

Less—accumulated depreciation

    (77,991 )   (53,278 )
           

Property, plant and equipment, net

  $ 453,685   $ 366,046  
           

        Depreciation expense for the years ended December 31, 2012, 2011 and 2010 was $25.0 million, $18.2 million and $17.6 million, respectively.

        Buildings under construction consists of direct costs relating to our construction projects, including capitalized interest. We completed the expansion of our corporate headquarters located in Maryland and our North Carolina facility during the first and second quarters of 2012, respectively. For the years ended December 31, 2012 and 2011, we capitalized $905,000 and $842,000 of interest expense, respectively.

  • Treasury Stock

        Treasury stock is recorded at cost, including commissions and fees. The cost of treasury shares sold is determined using the first-in, first-out method. Related gains and losses on sales of treasury stock are recognized as adjustments to stockholders' equity.

  • Revenue Recognition

    Remodulin and Tyvaso

        We sell both Remodulin and Tyvaso to our specialty pharmaceutical distributors under similar contractual arrangements. Sales of Remodulin and Tyvaso are recognized when title and risk of ownership pass to our distributors upon satisfactory delivery—i.e., when all of our performance obligations under these distributor arrangements have been satisfied. We record sales of Remodulin and Tyvaso net of various product sales allowances in the period that associated revenues are recognized. These sales allowances include estimated rebates, prompt payment discounts and service fees to our distributors. Calculating these sales allowances involves the use of significant estimates and judgments and information from external sources.

        We derive our provisions for rebates from an analysis of historical levels of rebates to both state Medicaid agencies and third-party payers by product, relative to sales of each product. In formulating our estimates, we also consider the impact of anticipated changes in our product pricing, sales trends and government rebate programs, particularly as they relate to eligibility requirements and/or rebate pricing. Since rebate eligibility and pricing requirements can differ for Remodulin and Tyvaso, we analyze rebate data separately for each of these products.

        We estimate prompt pay discounts based on observed payment behavior. Our distributors have routinely taken advantage of these discounts and we expect them to continue to do so.

        We pay our distributors for contractual services rendered and accrue for related fees based on contractual rates applied to the estimated units of service provided by distributors for a given financial reporting period.

        Our distributors do not possess return rights; however, we provide exchange rights in the event that product is damaged during shipment or expires. Exchanges for damaged product are highly infrequent. In the event that Remodulin or Tyvaso has been damaged during shipment and we have been promptly notified as required under our distributor arrangements, we do not recognize revenue on that shipment until damaged product has been replaced. Replacement of damaged product generally occurs within several days after we are notified of the damage. Furthermore, the number of product exchanges due to expiration has been minimal because we sell Remodulin and Tyvaso with a remaining shelf life in excess of one year and our distributors typically carry a thirty- to sixty-day supply of our products at any given time. In addition, we closely track inventory levels in the distribution channels. Except for contractual minimum inventory levels to prevent shortages of drug supply, we do not require, nor do we provide incentives for our distributors to assume, inventory levels of Remodulin or Tyvaso beyond what would be considered reasonable and customary in the ordinary course of business.

        The financial effects of exchange rights for Remodulin and Tyvaso have been immaterial and we expect the volume of exchanges to be consistent with historical levels. Specifically, exchanges of Remodulin and Tyvaso have comprised substantially less than one percent of the volume of the units that we sell. Because historical and anticipated future exchanges of Remodulin and Tyvaso have been and are expected to be immaterial, we do not record a reserve for estimated exchange rights in the period of sale. Lastly, we closely monitor product exchange data for both of these therapies to ensure that our assumptions continue to be reasonable, appropriate and current.

  • Adcirca

        Adcirca is manufactured for us by Eli Lilly and Company (Lilly) and distributed through Lilly's pharmaceutical wholesaler network. Specifically, Lilly handles all of the administrative functions associated with the sale of Adcirca on our behalf, including the receipt and processing of customer purchase orders, shipment to customers, and invoicing and collection of customer payments. In addition, sales terms for Adcirca include return rights that extend throughout the distribution channel. We recognize sales of Adcirca on a gross basis (net of allowances) upon delivery to customers due to the following factors: (1) we are responsible for the acceptability of the product purchased by wholesalers; (2) we bear all inventory risk, as title and risk of loss pass to us at the shipping point from Lilly's manufacturing facility; (3) we assume credit risk if Lilly is unable to collect amounts due from customers; and (4) we assume the risk and cost of a product recall, if required.

        We recognize sales of Adcirca net of: (1) estimated rebates (including discounts required under Medicare Part D); (2) prompt pay discounts; (3) allowances for product returns; and (4) wholesaler fees. We estimate our liability for rebates based on an analysis of historical levels of rebates to both Medicaid and commercial third-party payers. In addition, we determine our obligation for prescription drug discounts required for Medicare Part D patients within the coverage gap based on estimations of the number of Medicare Part D patients and the period such patients will remain within the coverage gap. We base our estimates for prompt pay discounts on observed customer payment behavior and expectations regarding the future utilization of such discounts. We derive estimates relating to the allowance for returns from published industry data specific to specialty pharmaceuticals and will continue to do so until we have sufficient historical data on which to base our allowance. In addition, we compare patient prescription data for Adcirca to sales of Adcirca on a quarterly basis to ensure a reasonable relationship between prescription and sales trends. To date, we have not identified any unusual patterns in the volume of prescriptions relative to sales that would warrant reconsideration of, or adjustment to, the methodology we currently employ to estimate our allowance for returns. Lastly, wholesaler fees are based on contractual percentages of sales to wholesalers.

  • Research and Development

        Research and development costs are expensed as incurred except for refundable payments made in advance of services to be provided to us. Related expenses consist of internal labor and overhead, costs to acquire pharmaceutical products and product rights for development, materials used in clinical trials and amounts paid to third parties for services and materials relating to drug development and clinical trials.

        We recognize the following as research and development expense in the period related costs are incurred:

  • Costs associated with in-house or contracted production activities prior to receiving FDA approval for such facilities, or for major unproven changes to our production processes;

    Costs incurred in licensing the rights to technologies in the research and development stage that have no alternative future uses; and

    Up-front payments made in connection with arrangements to obtain license and distribution rights to pharmaceutical product candidates prior to regulatory approval, absent any alternative future uses.

    Share-Based Compensation

        Share-based awards that require cash settlement upon exercise, such as those granted under our Share Tracking Award Plans, are classified as a liability. Accordingly, the fair value of related cash settled awards is re-measured at each reporting date until awards are exercised or are otherwise no longer outstanding. Related changes in the fair value of outstanding cash-settled awards at each financial reporting date are recognized as adjustments to share-based compensation expense.

        Generally, the fair value of a stock option grant is measured on its grant date and related compensation expense is recognized ratably over the requisite service period. Compensation expense is recognized in its entirety based on the grant-date fair value for stock option awards that vest immediately upon issuance. Compensation expense is accrued for performance-based stock option grants when we determine it is probable that the performance criteria will be met. We issue new shares of our common stock upon the exercise of stock options.

        We estimate the fair value of stock to be purchased through our employee stock purchase plan at the beginning of an offering period, or grant date, and recognize related compensation expense ratably over the requisite service period (the offering period). We will issue new shares of our common stock upon the end of each offering period, or exercise date.

  • Income Taxes

        Income taxes are accounted for in accordance with the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using the enacted tax rates that are expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance when, in our judgment, it is more likely than not that some or all of the deferred tax assets will not be realized.

        Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more likely than not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the largest amount that is more than 50 percent likely to be realized upon ultimate settlement. It is our policy to record interest and penalties related to uncertain tax positions as a component of income tax expense.

  • Earnings (Loss) per Share

        Basic earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period, plus the potential dilutive effect of other securities if such securities were converted or exercised. During periods in which we incur net losses, both basic and diluted loss per share is calculated by dividing the net loss by the weighted average shares outstanding—potentially dilutive securities are excluded from the calculation because their effect would be anti-dilutive.

  • Concentrations of Credit Risk, Products, Revenues and Customers

    Concentration of credit risk

        Financial instruments that are exposed to credit risk consist of cash, money market funds, commercial paper, marketable investments, and trade receivables. We maintain our cash and money market funds with financial institutions that are federally insured. While balances deposited in these institutions often exceed Federal Deposit Insurance Corporation limits, we have not experienced any losses on related accounts to date. Furthermore, we limit our risk exposure by maintaining funds in financial institutions that we believe are creditworthy and financially sound. Our investments in marketable debt securities have been issued by corporate entities and federally sponsored agencies with high credit ratings. We mitigate the risks associated with holding these types of securities by investing in highly-rated securities with relatively short maturities that we believe do not subject us to undue investment or credit risk. At any given time, our trade receivables are concentrated among a small number of principal customers. If any of these financial institutions, issuers or customers fail to perform their obligations under the terms of these financial instruments, our maximum exposure to potential losses would equal amounts reported on our consolidated balance sheets.

  • Concentration of products, revenues, and customers

        In the United States, we sell Remodulin and Tyvaso to three distributors. During the years ended December 31, 2012, 2011 and 2010, net sales of Remodulin and Tyvaso to these three distributors accounted for 78 percent, 81 percent and 84 percent, respectively, of our total net revenues. During the years ended December 31, 2012, 2011 and 2010, net sales of Remodulin accounted for 50 percent, 58 percent and 68 percent, respectively, of our total net revenues. Net sales of Tyvaso during the years ended December 31, 2012, 2011 and 2010 comprised 36 percent, 32 percent and 26 percent, respectively of our total net revenues.

        At December 31, 2012 and 2011, 60 percent and 68 percent, respectively, of our accounts receivable were due from our three U.S.-based distributors.

        During the years ended December 31, 2012, 2011 and 2010, we derived 56 percent, 61 percent and 65 percent of our total net revenues from one customer. Estimated net revenues from that customer were as follows (in thousands):

 
  Year Ended December 31,  
 
  2012   2011   2010  

Accredo Health Group, Inc. 

  $ 514,095   $ 455,504   $ 387,251