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DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2013
DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES
1. DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES
 
Raptor Pharmaceutical Corp. (the "Company" or "Raptor") is a biopharmaceutical company focused on developing and commercializing life-altering therapeutics that treat debilitating and often fatal diseases.

The Company's first product, PROCYSBI™ (cysteamine bitartrate) delayed-release capsules ("PROCYSBI"), received marketing approval from the U.S. Food and Drug Administration ("FDA") on April 30, 2013 for the management of nephropathic cystinosis in adults and children six years and older. The Company officially launched PROCYSBI the week of June 17 in the U.S., and PROCYSBI became available for shipment to cystinosis patients. Since inception, the Company had been in its development stage as defined by Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") 915, Development Stage Entities. With the marketing approval of PROCYSBI and the commencement of marketing operations, the Company is no longer considered to be in the development stage. In the near-term, the Company's ability to generate revenues is entirely dependent upon sales of PROCYSBI in the U.S.

On June 25, 2013, the FDA's Office of Orphan Product Development granted Raptor orphan drug exclusivity for PROCYSBI which began on the date of FDA approval and lasts seven years, subject to certain exceptions.

On June 27, 2013, the European Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") issued a positive opinion recommending marketing authorization for PROCYSBI 25mg and 75mg gastro-resistant hard capsules of cysteamine (International Nonproprietary Name: mercaptamine bitartrate) for the treatment of proven nephropathic cystinosis. The positive opinion from CHMP must be ratified by the European Union ("EU") Commission in order to grant marketing authorization for PROCYSBI, which would cover all 28 EU member countries plus Iceland, Norway and Liechtenstein. On July 22, 2013, Raptor announced that the EU Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug exclusivity for PROCYSBI gastro-resistant hard capsules for the treatment of proven nephropathic cystinosis. If the positive opinion on exclusivity is ratified by the EU commission, PROCYSBI marketing exclusivity would begin on the date of EU approval and would last ten years, subject to certain exceptions. Final adoption of the opinions on drug approval and orphan exclusivity is expected from the European Commission in the coming months.

Raptor's pipeline also includes RP103 in Phase 2/3 development for Huntington's disease and RP103 in Phase 2b development for nonalcoholic fatty liver disease ("NAFLD") in children. Raptor's other preclinical programs are based upon novel drug candidates that are designed to treat primary liver cancer and various other diseases.
 
The Company is subject to a number of risks, including: the success of the U.S. launch of PROCYSBI; the ratification by the EU Commission of the EMA's recommendation to grant an authorization to market PROCYSBI in the EU; the need to raise capital through equity and/or debt financings; the uncertainty of whether the Company's research and development efforts will result in additional commercial products; competition from larger organizations; reliance on licensing the proprietary technology of others; dependence on key personnel; uncertain patent protection; and dependence on corporate partners and collaborators. See the section titled "Risk Factors" included elsewhere in this Quarterly Report on Form 10-Q.
 
Change in Fiscal Year End
 
In December 2012, Raptor's board of directors approved a change in the Company's fiscal year end from August 31 to December 31. The accompanying condensed consolidated financial statements cover the period from January 1, 2013 through June 30, 2013, representing the first six months of Raptor's newly adopted fiscal year. The prior year's comparable six month period covers December 1, 2011 through May 31, 2012, which is reported on the basis of Raptor's previous fiscal year end. As a result of the change in Raptor's fiscal year end, the quarterly periods of Raptor's newly adopted fiscal year do not coincide with the historical quarterly periods that Raptor had previously reported. The Company did not recast the results for the 2012 fiscal periods because the financial reporting processes in place at the time included certain procedures that were only performed on a quarterly basis. Consequently, to recast these periods would have been impractical and would not have been cost-justified. The Company believes the comparative information provided for the three and six month periods ended May 31, 2012 provides a meaningful comparison to the three and six month periods ended June 30, 2013 and there are no factors, seasonal or otherwise, that materially impact the comparability of information or trends.
 
Basis of Presentation
 
The accompanying condensed consolidated financial statements reflect the results of operations of Raptor and have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP") and in conjunction with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments (including normal recurring accruals) considered necessary for the fair presentation of the Company's consolidated financial position, results of operations and cash flows for the periods presented. This Form 10-Q should be read in conjunction with the audited financial statements and accompanying notes in the Company's Transition Report on Form 10-KT for the four-month period ended December 31, 2012, as amended.

The Company's condensed consolidated financial statements include the accounts of the Company's direct and indirect wholly owned subsidiaries, Raptor Pharmaceuticals Inc., formerly known as Raptor Therapeutics Inc. which merged with Raptor Discoveries Inc. in December 2012 prior to changing its name and Raptor European Products, LLC, such subsidiaries incorporated in Delaware on August 1, 2007, and February 14, 2012, respectively, and Raptor Pharmaceuticals Europe B.V. (domiciled in the Netherlands and formed on December 15, 2009), Raptor Pharmaceuticals France SAS (incorporated in France on October 30, 2012) and RPTP European Holdings C.V. (located in the Grand Caymans and formed on February 16, 2012). All intercompany accounts have been eliminated. The Company's condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Through June 30, 2013, the Company had accumulated losses of approximately $176.0 million. Management expects to incur further losses for the foreseeable future.

The Company believes that based upon its projected PROCYSBI sales and planned operations, its cash and cash equivalents as of June 30, 2013 of approximately $74.6 million and net cash proceeds of approximately $11.2 million received in July 2013 from sales of common stock under its "at-the-market" ("ATM") offering will be sufficient to meet its projected operational requirements and obligations through the end of 2014.
 
Use of Estimates
 
The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
 
Revenue Recognition

The Company recognizes revenue in accordance with the FASB ASC 605, Revenue Recognition, when the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed; the seller's price to the buyer is fixed or determinable and collectability is reasonably assured. The Company determines that persuasive evidence of an arrangement exists based on written contracts that defined the terms of the arrangements. Pursuant to the contract terms, the Company determines when title to products and associated risk of loss has passed onto the customer. The Company assesses whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. The Company assesses collectability based primarily on the customer's payment history and on the creditworthiness of the customer. Without sufficient credit history, the Company determines a customary collectability percentage.

PROCYSBI is currently only available for distribution from the Company's specialty pharmacy partner, which ships directly to the patient. PROCYSBI is not available in retail pharmacies. Prior authorization of coverage level by the patient's private insurance plan or government payor is a prerequisite to the shipment of PROCYSBI to a patient. Revenue is recognized once the product has been shipped by the specialty pharmacy and receipt confirmed by the patient.

The Company records revenue net of expected discounts, distributor fees, rebates, including those paid to government agencies, and returns. Allowances are recorded as a reduction of revenue at the time product sales are recognized. Allowances for government rebates and discounts are established based on the actual payor information, which is known at the time of shipment, and the government-mandated discounts applicable to government-funded programs.
 
Inventories and Cost of Sales

Inventories are stated at the lower of cost or market price with cost determined on a first-in, first-out basis. Inventories are reviewed periodically to identify slow-moving or obsolete inventory based on sales activity, both projected and historical, as well as product shelf-life. In evaluating the recoverability of inventories produced in preparation for product launches, the Company considers the probability that revenue will be obtained from the future sale of the related inventory. Prior to the approval of PROCYSBI by the FDA on April 30 2013, the Company recorded manufacturing costs relating to PROCYSBI as research and development expense. Subsequent to approval, the Company began capitalizing these costs as commercial inventory. As of June 30, 2013, the Company's capitalized inventory was approximately $0.2 million, all of which was considered finished goods. Upon launching PROCYSBI in mid-June 2013, the Company began recognizing costs of sales. During the quarter ended June 30, 2013, the Company recorded $0.4 million as cost of sales representing commercial inventory that was capitalized subsequent to FDA approval but written off due to an unanticipated minor change in the finished product presentation which is not expected to be repeated in the future. Cost of sales includes the cost of inventory sold and reserved, manufacturing and supply chain costs, product shipping and handling costs, amortization of licensing approval milestone payments and licensing royalties payable to the University of California, San Diego ("UCSD").

Comprehensive Loss
 
Components of comprehensive loss are reported in the Company's Condensed Consolidated Statements of Comprehensive Loss in the period in which they are recognized. The components of comprehensive loss include net loss and foreign currency translation adjustments.
 
Cash and Cash Equivalents
 
The Company considers all highly liquid investments with original maturities of three months or less, when purchased, to be cash equivalents. The Company maintains cash and cash equivalents, which consist principally of money market funds with high credit quality financial institutions. Such amounts exceed Federal Deposit Insurance Corporation insurance limits. Restricted cash represents compensating balances required by the Company's U.S. and European banks as collateral for credit cards.
 
Short-term Investments
 
The Company typically invests in short-term investments in high credit-quality funds in order to obtain higher yields on its cash available for investment. Short-term investments were $0 and approximately $22.1 million, as of June 30, 2013 and December 31, 2012, respectively. The Company is currently evaluating its short-term investment fund options and in the future may invest a portion of its cash and cash equivalents balance ($74.6 million as of June 30, 2013) in high credit-quality, and high-yielding short-term investment funds.
 
Such investments are not insured by the Federal Deposit Insurance Corporation. The Company completed an evaluation of its investments and determined that it did not have any other-than-temporary impairments at December 31, 2012. The investments were placed in financial institutions with strong credit ratings.
 
Accounts Receivable

Trade accounts receivable are recorded net of product sales allowances for prompt-payment discounts, chargebacks and doubtful accounts. Estimates for chargebacks and prompt-payment discounts are based on contractual terms and the Company's expectations regarding the utilization rates. As of June 30, 2013, the Accredo Health Group, Inc. ("Accredo"), Raptor's exclusive distributor in the U.S., is the Company's only significant customer for PROCYSBI in the U.S.

Functional Currency
 
The Company's consolidated functional currency is the U.S. dollar. Raptor Pharmaceuticals Europe B.V. ("BV"), Raptor Pharmaceuticals France SAS ("SAS") and RPTP European Holdings C.V. ("CV"), the Company's European subsidiaries and Cayman-based subsidiary, respectively, use the European Euro as their functional currency. At each quarter end, BV's, SAS's and CV's balance sheets are translated into U.S. dollars based upon the quarter-end exchange rate, while their statements of comprehensive loss are translated into U.S. dollars based upon an average of the Euro's value between the beginning and end date of the reporting period. BV's, SAS's and CV's equity are adjusted for any translation gain or loss.
 
Fair Value of Financial Instruments
 
The carrying amounts of certain of the Company's financial instruments including cash and cash equivalents, restricted cash, prepaid expenses, accounts payable, accrued liabilities and capital lease liability approximate fair value due either to length of maturity or interest rates that approximate prevailing market rates unless otherwise disclosed in these condensed consolidated financial statements. The warrant liability is carried at fair value which is determined using the Black-Scholes option valuation model at the end of each reporting period.
 
The Company uses a fair value approach to value certain assets and liabilities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The hierarchy consists of three levels:

·
Level one - Quoted market prices in active markets for identical assets or liabilities;
·
Level two - Inputs other than level one inputs that are either directly or indirectly observable; and
·
Level three - Unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use.
 
Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each quarter. Assets and liabilities measured at fair value on a recurring basis at June 30, 2013 and December 31, 2012 are summarized as follows:

(In thousands)
        
Assets
Level 1
 
Level 2
 
Level 3
 
June 30, 2013
 
 
        
Fair value of cash equivalents
 
$
69,142
  
$
0
  
$
0
  
$
69,142
 
Restricted cash
  
0
   
213
   
0
   
213
 
Total
 
$
69,142
  
$
213
  
$
0
  
$
69,355
 
 
                
Liabilities
                
Fair value of common stock warrants
 
$
0
  
$
0
  
$
13,468
  
$
13,468
 
Total
 
$
0
  
$
0
  
$
13,468
  
$
13,468
 
 
                
 
                
Assets
Level 1
 
Level 2
 
Level 3
 
December 31, 2012
 
 
                
Fair value of cash equivalents
 
$
35,069
  
$
0
  
$
0
  
$
35,069
 
Restricted cash
  
0
   
163
   
0
   
163
 
Short-term investments
  
22,096
   
0
   
0
   
22,096
 
Total
 
$
57,165
  
$
163
  
$
0
  
$
57,328
 
 
                
Liabilities
                
Fair value of common stock warrants
 
$
0
  
$
0
  
$
16,405
  
$
16,405
 
Total
 
$
0
  
$
0
  
$
16,405
  
$
16,405
 
 
Intangible Assets
 
Intangible assets include the intellectual property and other rights relating to DR Cysteamine (developed as PROCYSBI and RP103), capitalized licensing milestone payments to UCSD based upon drug approval and to an out-license acquired in the merger of the Company's subsidiary with and into Raptor Pharmaceuticals Corp. in September 2009 ("2009 Merger"). The intangible assets related to intellectual property of PROCYSBI/RP103 are amortized using the straight-line method over the estimated useful life of 20 years, which is the life of the intellectual property patents. The 20-year estimated useful life is also based upon the typical development, approval, marketing and life cycle management timelines of pharmaceutical drug products. Licensing milestone payments are amortized upon relevant regulatory approval through 2027, the remaining life of the patent. Intangible assets related to the out-license are amortized using the straight-line method over the estimated useful life of 16 years, which is the life of the intellectual property patents.
 
Goodwill
 
Goodwill represents the excess of the value of the purchase consideration over the identifiable assets acquired in the 2009 Merger. Goodwill is reviewed annually, or when an indication of impairment exists. When an impairment analysis is performed, if deemed necessary, a write-down in valuation is recorded.

Fixed Assets
 
Fixed assets, which mainly consist of leasehold improvements, furniture and fixtures, lab equipment, computer hardware and software and capital lease equipment, are stated at cost. Depreciation is computed using the straight-line method over the related estimated useful lives, except for leasehold improvements and capital lease equipment, which are depreciated over the shorter of the useful life of the asset or the lease term. Significant additions and improvements that have useful lives estimated at greater than one year are capitalized, while repairs and maintenance are charged to expense as incurred.

Impairment of Long-Lived Assets
 
The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset's fair value or discounted estimates of future cash flows.
 
Accrued Liabilities
 
Accrued liabilities include estimates of certain expenses for which the Company has not yet been invoiced and which requires management's judgment in determining appropriate expenses to accrue. For example, because of the nature of how clinical trials are invoiced by clinical sites, especially outside of the U.S. where there is a significant time lag between the services provided by the clinical site and the time the clinical site bills the Company for their services, the Company must estimate such clinical site expenses on a monthly basis as clinical trial expenses. Although the Company believes its accrued liabilities reflect the best information available to it, the Company's actual expenses could differ from its estimates.
 
Common Stock Warrant Liabilities
 
The warrants issued by the Company in the 2010 private placement contain a cash-out provision which may be triggered upon request by the warrant holders if the Company is acquired or upon the occurrence of certain other fundamental transactions involving the Company. This provision requires these warrants to be classified as liabilities and to be marked to market at each period-end commencing on August 31, 2010. The warrants issued by the Company in its December 2009 equity financing contain a conditional obligation that may require the Company to transfer assets to repurchase the warrants upon the occurrence of potential future events. Under FASB ASC Topic 480, Distinguishing Liabilities from Equity ("ASC 480"), a financial instrument that may require the issuer to settle the obligation by transferring assets is classified as a liability. Therefore, the Company has classified the warrants as liabilities and will mark them to fair value at each period end. The common stock warrants are re-measured at the end of every reporting period with the change in value reported in the Company's Condensed Consolidated Statements of Comprehensive Loss. Warrants which are recorded as liabilities that are exercised are re-measured and marked to market the day prior to exercise. Upon exercise of such warrants, the fair value of such warrants is reclassified to equity.
 
Deferred Offering Costs
 
Deferred offering costs represent expenses incurred to raise equity capital related to financing transactions which have not yet been completed as of the balance sheet dates.
 
Note Payable and Debt Issuance Costs
 
Note payable consists of the Company's loan agreement with HealthCare Royalty Partners II, L.P. ("HC Royalty"), as lender, under which Raptor agreed to borrow $50.0 million in two $25.0 million tranches. The first tranche was received in December 2012 and the second tranche was received on May 21, 2013. The loan bears interest at an annual fixed rate of 10.75% of outstanding principal and quarterly interest payments are included in interest expense in the Condensed Consolidated Statements of Comprehensive Loss. Principal payments, when made, reduce the note payable balance. There is a synthetic royalty component based on net product sales, including PROCYSBI, in a calendar year, and such royalty is payable quarterly. The royalty fees payable to HC Royalty are included as interest expense. Debt issuance costs, which were capitalized and included in other long-term assets, are being amortized over the life of the loan using the effective interest method. The amortization of debt issuance costs is included in interest expense in the Condensed Consolidated Statements of Comprehensive Loss.
 
Research and Development Costs
 
Research and development costs are charged to expense as incurred. Research and development expenses include medical, clinical, regulatory and scientists' salaries and benefits, lab collaborations, preclinical studies, clinical trials, clinical trial materials, commercial drug manufacturing prior to obtaining marketing approval, regulatory and clinical consultants, lab supplies, lab services, lab equipment maintenance and small equipment purchased to support the research laboratory, amortization of intangible assets and allocated human resources and facilities expenses. Research and development expenses are offset by contra-expenses, which are reimbursements of research and development expenses received either from research collaborators or from government grants or tax rebates.
 
Income Taxes
 
Income taxes are recorded under the liability method, under which deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
 
The Company's effective tax rate is 0% for income tax for the three and six months ended June 30, 2013. The Company has determined that its effective tax rate for fiscal year ended August 31, 2012 and the short tax year from September 1, 2012 to December 31, 2012 is 0%. Based on the weight of available evidence, including cumulative losses since inception and expected future losses, the Company has determined that it is more likely than not that the deferred tax asset amount will not be realized and therefore a full valuation allowance has been provided on the Company's net deferred tax assets.
 
Utilization of the Company's net operating loss ("NOL") carryovers may be subject to substantial annual limitation due to the ownership change rules under the Internal Revenue Code and similar state income tax law provisions including those related to the suspension and limitation of NOL carryovers for certain tax years. Such an annual limitation could result in the expiration of the NOL carryovers before utilization.
 
The Company accounts for income taxes under FASB ASC No. 740-10, Accounting for Uncertainty in Income Taxes. Under this approach, deferred tax assets and liabilities are recognized based on anticipated future tax consequences, using currently enacted tax laws attributed to temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts calculated for income tax purposes.
 
The Company's continuing practice is to recognize interest and/or penalties related to income tax matters as a component of income tax expense. As of June 30, 2013, there were no accrued interest or penalties related to uncertain tax positions. As of June 30, 2013, there were no unrecognized tax benefits for which the liability for such taxes were recognized as deferred liabilities.
 
The Company files U.S. Federal, California and other state income tax returns. In addition, the Company files income tax returns in France and the Netherlands. The Company is currently not subject to any income tax examinations. Due to the Company's NOLs, generally all tax years remain open.
 
Net Loss per Share
 
Net loss per share is calculated by dividing net loss by the weighted-average shares of common stock outstanding during the period. Diluted net income per share is calculated by dividing net income by the weighted-average shares of common stock outstanding and potential shares of common stock during the period. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted net loss per share as their effect is anti-dilutive. Potentially dilutive securities include:

 
 
For the six months ended
 
(In thousands)
 
June 30, 2013
 
 
May 31, 2012
 
Warrants to purchase common stock
 
 
2,213
 
 
 
5,188
 
Options to purchase common stock
 
 
8,336
 
 
 
6,095
 
 
 
 
 
 
 
 
 
 
Total potentially dilutive securities
 
 
10,549
 
 
 
11,283
 
 
 
 
 
 
 
 
 
 

Net loss per share, basic and diluted, was $(0.43) and $(0.06) for the three months ended June 30, 2013 and May 31, 2012, respectively, and $(0.73) and $(0.35) for the six months ended June 30, 2013 and May 31, 2012, respectively.

 Stock Option Plan
 
Effective September 1, 2006, the Company adopted the provisions of FASB ASC Topic 718, Accounting for Compensation Arrangements, ("ASC 718") (previously listed as Statement of Financial Accounting Standards ("SFAS") No. 123 (revised 2004), Share-Based Payment) in accounting for its stock option plans. Under ASC 718, compensation cost is measured at the grant date based on the fair value of the equity instruments awarded and is recognized over the period during which an employee is required to provide service in exchange for the award, or the requisite service period, which is usually the vesting period. The fair value of the equity award granted is estimated on the date of the grant. The Company accounts for stock options issued to third parties, including consultants, in accordance with the provisions of the FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees, ("ASC 505-50") (previously listed as Emerging Issues Task Force Consensus No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services). See Note 7, Stock Option Plans, for further discussion of employee stock-based compensation.

For the quarter ended June 30, 2013, stock-based compensation expense was based on the Black-Scholes option-pricing model assuming the following: risk-free interest rate of 0.92%; five year expected life; 78% volatility; 2.5% turnover rate; and 0% dividend rate.

The Black-Scholes inputs were based on the following factors:

·
the risk-free interest rate was based upon the Company's review of current constant maturity treasury bill rates for five years;
·
the expected life of five years was based upon the Company's assessment of the ten-year term of the stock options issued along with the fact that the Company is a commercial company and anticipates that option holders will commence exercising stock options that are fully vested;
·
the volatility was based on the actual annualized volatility of the Company's common stock price as quoted on NASDAQ since the closing of the 2009 Merger on September 30, 2009;
·
the turnover rate was based on an assessment of the Company's historical employee turnover; and
·
the dividend rate was based on the Company's current decision to not pay dividends on its stock during its current stage.
 
Reclassifications
 
Certain amounts previously reported under specific financial statement captions have been reclassified to be consistent with the current period presentation.