Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Oct. 31, 2013 | |
Document And Entity Information | ' | ' |
Entity Registrant Name | 'NPS PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0000890465 | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Effective Date | 30-Sep-13 | ' |
Document Period Start Date | 1-Jan-13 | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Well-known Seasoned Issuer | 'Yes | ' |
Entity Voluntary Filers | 'No | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Large Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 102,101,240 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets | ' | ' |
Cash and cash equivalents | $46,267 | $17,471 |
Marketable investment securities | 131,334 | 83,244 |
Accounts receivable | 31,986 | 30,276 |
Inventory | 27,580 | 0 |
Prepaid expenses | 4,211 | 4,317 |
Other current assets | 2,235 | 1,743 |
Total current assets | 243,613 | 137,051 |
Property and equipment, net | 3,860 | 4,193 |
Goodwill | 9,429 | 9,429 |
Intangibles, net | 19,750 | 0 |
Debt issuance costs, net | 361 | 436 |
Total assets | 277,013 | 151,109 |
Current Liabilities | ' | ' |
Accounts payable and accrued expenses | 24,207 | 23,289 |
Convertible notes payable | 16,545 | 0 |
Current portion of non-recourse debt | 6,670 | 6,278 |
Total current liabilities | 47,422 | 29,567 |
Convertible notes payable | 0 | 16,545 |
Non-recourse debt, less current portion | 132,387 | 153,024 |
Other liabilities | 5,372 | 6,614 |
Total liabilities | 185,181 | 205,750 |
Commitments and contingencies (notes 6 and 8) | ' | ' |
Stockholders' equity (deficit): | ' | ' |
Preferred stock, $0.001 par value. Authorized 5,000,000 shares; issued and outstanding no shares | 0 | 0 |
Common stock, $0.001 par value. Authorized 175,000,000 shares; issued and outstanding 102,087,311 shares and 86,799,049 shares, respectively | 102 | 87 |
Additional paid-in capital | 1,122,168 | 954,452 |
Accumulated other comprehensive income | 19 | 5 |
Accumulated deficit | -1,030,457 | -1,009,185 |
Total stockholders' equity (deficit) | 91,832 | -54,641 |
Total liabilities and stockholders' equity (deficit) | $277,013 | $151,109 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Stockholders' deficit | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 175,000,000 | 175,000,000 |
Common stock, shares issued | 102,087,311 | 86,779,049 |
Common stock, shares outsatnding | 102,087,311 | 86,779,049 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenues: | ' | ' | ' | ' |
Product sales, net | $11,037 | $0 | $16,492 | $0 |
Royalties | 28,129 | 27,012 | 84,613 | 78,453 |
Sale of royalty rights | 0 | 0 | 0 | 25,000 |
Other | 36 | 7 | 36 | 7 |
Total revenues | 39,202 | 27,019 | 101,141 | 103,460 |
Operating expenses: | ' | ' | ' | ' |
Cost of goods sold | 1,077 | 0 | 1,615 | 0 |
Research and development | 18,798 | 17,957 | 65,381 | 70,797 |
Selling, general and administrative | 17,558 | 8,329 | 46,228 | 25,769 |
Total operating expenses | 37,433 | 26,286 | 113,224 | 96,566 |
Operating income (loss) | 1,769 | 733 | -12,083 | 6,894 |
Other income (expense) | ' | ' | ' | ' |
Interest income, net | 108 | 64 | 221 | 224 |
Interest expense | -2,959 | -4,444 | -9,388 | -14,445 |
Other | -5 | 323 | -18 | 795 |
Total other expense, net | -2,856 | -4,057 | -9,185 | -13,426 |
Loss before income tax expense | -1,087 | -3,324 | -21,268 | -6,532 |
Income tax expense | 0 | 0 | 4 | 0 |
Net loss | ($1,087) | ($3,324) | ($21,272) | ($6,532) |
Net loss per common and potential common share | ' | ' | ' | ' |
Basic | ($0.01) | ($0.04) | ($0.22) | ($0.08) |
Diluted | ($0.01) | ($0.04) | ($0.22) | ($0.08) |
Weighted average common and potential common shares outstanding | ' | ' | ' | ' |
Basic | 102,227 | 86,947 | 96,034 | 86,910 |
Diluted | 102,227 | 86,947 | 96,034 | 86,910 |
Condensed_Conslidated_Statemen
Condensed Conslidated Statements of Comprehensive Income (Loss) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Statement of Comprehensive Income [Abstract] | ' | ' | ' | ' |
Net (loss) | ($1,087) | ($3,324) | ($21,272) | ($6,532) |
Unrealized gains (losses) on securities: | ' | ' | ' | ' |
Unrealized holding (losses) gains arising during period | 89 | 35 | 16 | 141 |
Reclassification for recognized gain (loss) on marketable investment securities during the period | 0 | 0 | -2 | -3 |
Net unrealized (loss) gain on marketable investment securities | 89 | 35 | 14 | 138 |
Foreign currency translation (loss) gain | -9 | -8 | 0 | -13 |
Other comprehensive income | 80 | 27 | 14 | 125 |
Comprehensive loss | ($1,007) | ($3,297) | ($21,258) | ($6,407) |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ' | ' |
Net loss | ($21,272) | ($6,532) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 1,871 | 799 |
Accretion of premium on marketable investment securities | 1,962 | 1,550 |
Shares issued for payment of services | 549 | 0 |
Non-cash interest expense | 8,674 | 13,727 |
Non-cash royalties | -29,831 | -45,878 |
Compensation expense on share-based awards | 7,343 | 4,879 |
Realized gain on sale of marketable investment securities | -2 | -3 |
(Increase) decrease in operating assets: | ' | ' |
Accounts receivable | -4,041 | -14,865 |
Inventory | 6,118 | 0 |
Prepaid expenses, other current assets and other assets | 528 | 3,182 |
(Decrease) increase in operating liabilities: | ' | ' |
Accounts payable and accrued expenses | 4,263 | 2,176 |
Other liabilities | -1,242 | -1,168 |
Net cash used in operating activities | -25,080 | -42,133 |
Cash flows from investing activities: | ' | ' |
Sales of marketable investment securities | 6,451 | 2,526 |
Maturities of marketable investment securities | 58,251 | 76,914 |
Purchases of marketable investment securities | -114,738 | -67,668 |
Acquisitions of property and equipment | -608 | -858 |
Net cash (used in) provided by investing activities | -50,644 | 10,914 |
Cash flows from financing activities: | ' | ' |
Net proceeds from the sale of common stock | 93,454 | 0 |
Net proceeds from the exercise of stock options | 11,684 | 903 |
Shares withheld for the payment of taxes | -618 | 0 |
Net cash provided by financing activities | 104,520 | 903 |
Effect of exchange rate changes on cash | 0 | -13 |
Net increase (decrease) in cash and cash equivalents | 28,796 | -30,329 |
Cash and cash equivalents at beginning of period | 17,471 | 82,401 |
Cash and cash equivalents at end of period | 46,267 | 52,072 |
Supplemental Disclosures of Cash Flow Information | ' | ' |
Cash paid for interest | 712 | 714 |
Cash paid for income taxes | 4 | 0 |
Supplemental Disclosure of Non-cash Investing and Financing Activities | ' | ' |
6.1 million shares of NPS common stock issued in connection with the Takeda Termination and Transition agreement, see note 10 | 55,403 | 0 |
Unrealized gains on marketable investment securities | 14 | 138 |
Accrued acquisition of property and equipment | 69 | 45 |
Noncash reduction of debt | $20,245 | $44,971 |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Parenthetical) | 9 Months Ended |
Sep. 30, 2013 | |
Statement of Cash Flows [Abstract] | ' |
6.1 million shares of NPS common stock issued | 6,100,000 |
Description_of_Business_and_Si
Description of Business and Significant Accounting Policies - Note 1 | 9 Months Ended |
Sep. 30, 2013 | |
Description of Business and Significant Accounting Policies Disclosure | ' |
Basis of Presentation and Significant Accounting Policies [Text Block] | ' |
(1) Description of Business and Significant Accounting Policies | |
The accompanying unaudited condensed consolidated financial statements included herein have been prepared by NPS Pharmaceuticals, Inc. (NPS or the Company) in accordance with the rules and regulations of the United States Securities and Exchange Commission (SEC). The condensed consolidated financial statements are comprised of the financial statements of NPS and its subsidiaries collectively referred to as the Company. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by U.S. generally accepted accounting principles has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2013. | |
These condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2012, included in NPS' 2012 Annual Report on Form 10-K filed with the SEC. | |
The preparation of the condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. generally accepted accounting principles. Actual results could differ from these estimates. | |
Subsequent Events | |
The Company has evaluated all events and transactions since September 30, 2013. The Company did not have any material recognized or non-recognized subsequent events. | |
Significant Accounting Policies | |
There were no material changes in the Company's significant accounting policies from those at December 31, 2012; however, the following information, which relates to the U.S. launch of Gattex in February 2013, is in addition to, and should be read in conjunction with, the accounting policies included in the Company's Annual Report on Form 10-K for the year ended December 31, 2012. | |
Product Sales. Product sales represent U.S. sales of Gattex, which was approved by the U.S. Food and Drug Administration (FDA) in December 2012. The Company recognizes revenue from Gattex product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer is reasonably assured, the Company has no further performance obligations, and returns can be reasonably estimated. | |
All prescriptions for Gattex, received directly by NPS from the patient's physician, are handled through NPS Advantage, the Company's data management and patient support program, which investigates and determines the patient's insurance coverage for Gattex. Once coverage is confirmed, NPS forwards the prescription to the specialty pharmacy (SP) who then re-confirms the coverage and dispenses Gattex to the patient. The Company sells Gattex directly to a limited number of SPs and a specialty distributor (SD) who dispense product to patients, hospitals or U.S. government entities. The Company invoices and records revenue when the SPs or SD receives Gattex from the Company's third-party logistics warehouse. The Company's SPs order product to fill prescriptions that have been approved for reimbursement by payers. | |
Specific considerations for Gattex sold in the U.S. are as follows: | |
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. The allowance for rebates is based on statutory discount rates and expected utilization. The Company's estimate for expected utilization for rebates is based in part on actual and pending prescriptions for which it has validated the insurance benefits. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase from the Company's SPs or SD. Contracted customers, which currently consist primarily of Public Health Service institutions and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The Company's SPs or SD, in turn, charge back the difference between the price initially paid by the SP or SD and the discounted price paid to the SP or SD by the customer. The allowance for chargebacks is based on actual and expected sales to the SPs and SD. | |
SP and SD Fees and Deductions: The Company's SPs and its SD are offered prompt payment discounts and are paid fees for their services and data. | |
Product returns: The Company will accept product that is damaged or defective when shipped directly to the SP or SD from the Company's third-party logistics provider or for product that is returned with more than two (2) months remaining until the expiration date from its SP or SD only. The Company will not provide any credit for product that has been labeled for or sent to a patient. Product returned is generally not resalable as the product must be temperature-controlled throughout the supply chain and such control is difficult to confirm. The Company makes a reasonable estimate of future potential product returns based on the number of prescriptions that have been approved for reimbursement and sent to an SP with each corresponding shipment of Gattex that has been sent to each respective SP. The Company also has the visibility to see current inventory levels and the current shelf life at the SPs and SD and has the ability to control the amount of product that is sold to the SPs and SD. At the end of each reporting period, the Company determines a product returns reserve by evaluating the units held in its distribution channel, the underlying demand for such units and the risk of potential product returns. At September 30, 2013 the Company recorded a product returns reserve of approximately $119,000 that it believes could be returned in the future. | |
Product sales are recorded net of accruals for estimated rebates, chargebacks, discounts, and other deductions (collectively, sales deductions) and returns. With the exception of allowances for prompt payment, allowances for sales deductions and returns are included in accounts payable and accrued expenses in the accompanying consolidated balance sheets. | |
Inventory. Inventories are stated at the lower of cost or estimated realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products after regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes-down such inventories as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to cost of goods sold to write down such unmarketable inventory to its estimated realizable value. | |
Income_Loss_Per_Common_Share_N
Income (Loss) Per Common Share - Note 2 | 9 Months Ended |
Sep. 30, 2013 | |
Income (Loss) Per Common Share | ' |
(2) Income (Loss) Per Common Share | |
Basic net income (loss) per common share is the amount of income (loss) for the period divided by the weighted average shares of common stock outstanding during the reporting period. Diluted income (loss) per common share is the amount of income (loss) for the period plus interest expense on convertible debt divided by the sum of weighted average shares of common stock outstanding during the reporting period and weighted average shares that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares. | |
Potential common shares of approximately 7.4 million and 6.7 million during the three and nine months ended September 30, 2013, respectively and 6.7 million and 8.9 million during the three and nine months ended September 30, 2012, respectively that could potentially dilute basic income per share in the future were not included in the computation of diluted income (loss) per share because to do so would have been anti-dilutive for the periods presented. Potential dilutive common shares related to convertible debt were approximately 3.0 million common shares for the three and nine months ended September 30, 2013 and 2012, respectively. Additionally, potential dilutive common shares related to stock options, restricted stock and restricted stock units were 4.4 million and 3.6 million common shares for the three and nine months ended September 30, 2013, respectively, and 4.9 million and 4.8 million common shares, for the three and nine months ended September 30, 2012, respectively. | |
Fair_Value_Measurement_Note_3
Fair Value Measurement - Note 3 | 9 Months Ended | ||||||||||||||
Sep. 30, 2013 | |||||||||||||||
Fair Value Measurement Disclosure | ' | ||||||||||||||
Fair Value Measurement | ' | ||||||||||||||
(3) Fair Value Measurement | |||||||||||||||
The Company's financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. The three levels are as follows: | |||||||||||||||
Level 1- Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. | |||||||||||||||
Level 2- Inputs are other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). | |||||||||||||||
Level 3- Inputs are unobservable and reflect the Company's assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available. | |||||||||||||||
Summary of Assets Recorded at Fair Value | |||||||||||||||
In accordance with the fair value hierarchy described above, the following table shows the fair value of the Company's financial assets (only marketable investment securities) that are required to be measured at fair value as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||||||||||
As of September 30, 2013: | Level 1 | Level 2 | Level 3 | Total | |||||||||||
Marketable investment securities | $ | 120,618 | $ | 10,716 | $ | - | $ | 131,334 | |||||||
As of December 31, 2012: | Level 1 | Level 2 | Level 3 | Total | |||||||||||
Marketable investment securities | $ | 67,723 | $ | 15,521 | $ | - | $ | 83,244 | |||||||
As of September 30, 2013 and December 31, 2012, the fair values of the Company's Level 2 securities were $10.7 million and $15.5 million, respectively. These securities are certificates of deposit or commercial paper issued by domestic companies with an original maturity of greater than ninety days but less than 18 months. These securities are currently rated A-1 or higher. The Company's cash equivalents are classified within Level 1 or Level 2 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets. These investments are initially valued at the transaction price and subsequently valued utilizing third party pricing providers or other market observable data. Data used in the analysis include reportable trades, broker/dealer quotes, bids and offers, benchmark yields and credit spreads. The Company validates the prices provided by its third party pricing providers by reviewing their pricing methods, analyzing pricing inputs and confirming that the securities have traded in normally functioning markets. The Company did not adjust or override any fair value measurements provided by its pricing providers as of September 30, 2013 or December 31, 2012. | |||||||||||||||
As of September 30, 2013 and December 31, 2012, the Company did not have any investments in Level 3 securities. | |||||||||||||||
There were no transfers of assets or liabilities between level 1 and level 2 during the three or nine months ended September 30, 2013 and 2012. | |||||||||||||||
The carrying amounts reflected in the condensed consolidated balance sheets for certain short-term financial instruments including accounts receivable, accounts payable, accrued expenses, and other liabilities approximate fair value due to their short-term nature except that the estimated fair value and carrying value of a royalty liability to the Brigham and Women's Hospital related to sales of cinacalcet HCl using a discounted cash flow model is approximately $4.2 million and $5.6 million, respectively, at September 30, 2013 and $4.8 million and $6.6 million, respectively, at December 31, 2012. | |||||||||||||||
Summary of Liabilities Recorded at Carrying Value | |||||||||||||||
The fair and carrying value of our debt instruments are detailed as follows (in thousands): | |||||||||||||||
As of September 30, 2013 | As of December 31, 2012 | ||||||||||||||
Fair | Carrying | Fair | Carrying | ||||||||||||
Value | Value | Value | Value | ||||||||||||
5.75% Convertible Notes | $ | 96,748 | $ | 16,545 | $ | 28,131 | $ | 16,545 | |||||||
Sensipar Notes | 60,588 | 61,065 | 79,129 | 80,234 | |||||||||||
PTH 1-84 (Europe, CIS and Turkey) | |||||||||||||||
-Secured Debt | 27,597 | 42,790 | 28,605 | 42,816 | |||||||||||
Regpara-Secured Debt | 38,661 | 35,202 | 48,887 | 36,252 | |||||||||||
Total | $ | 223,594 | $ | 155,602 | $ | 184,752 | $ | 175,847 | |||||||
The fair values of the Company's convertible notes were estimated using the (i) terms of the convertible notes; (ii) rights, preferences, privileges, and restrictions of the underlying security; (iii) time until any restriction(s) are released; (iv) fundamental financial and other characteristics of the Company; (v) trading characteristics of the underlying security (exchange, volume, price, and volatility); and (vi) precedent sale transactions. The fair values of the Company's non-recourse Sensipar notes, PTH 1-84 (Europe, Commonwealth of Independent States (CIS) and Turkey)-secured debt and Regpara-secured debt were estimated using a discounted cash flow model. Within the hierarchy of fair value measurements, these are Level 3 fair values. | |||||||||||||||
Financial_Instruments_Note_4
Financial Instruments - Note 4 | 9 Months Ended | ||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||
Financial Instruments Disclosure | ' | ||||||||||||||||||
Financial Instruments | ' | ||||||||||||||||||
(4) Financial Instruments | |||||||||||||||||||
Financial instruments that potentially subject the Company to concentrations of credit risk are accounts receivable and marketable investment securities. The majority of the Company's accounts receivable are payable by pharmaceutical companies and specialty pharmacies and collateral is generally not required from these companies. Substantially all of the Company's royalty revenues for the three and nine months ended September 30, 2013 and 2012 were from three and four licensees, respectively, and substantially all of the Company's accounts receivable balances at September 30, 2013 and December 31, 2012 were from three licensees. Substantially all of the Company's product sales revenues for the three and nine months ended September 30, 2013 and substantially all of the Company's trade accounts receivable balances at September 30, 2013 were from six specialty pharmacies. The Company's portfolio of marketable investment securities is subject to concentration limits set within the Company's investment policy that help to mitigate its credit exposure. | |||||||||||||||||||
The following is a summary of the Company's marketable investment securities (in thousands): | |||||||||||||||||||
Gross | Gross | ||||||||||||||||||
unrealized | unrealized | ||||||||||||||||||
Amortized | holding | holding | Fair | ||||||||||||||||
cost | gains | losses | value | ||||||||||||||||
As of September 30, 2013: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 94,058 | $ | 19 | $ | -45 | $ | 94,032 | |||||||||||
Government agency | 37,284 | 22 | -4 | 37,302 | |||||||||||||||
Total marketable investment securites | $ | 131,342 | $ | 41 | $ | -49 | $ | 131,334 | |||||||||||
Gross | Gross | ||||||||||||||||||
unrealized | unrealized | ||||||||||||||||||
Amortized | holding | holding | Fair | ||||||||||||||||
cost | gains | losses | value | ||||||||||||||||
As of December 31, 2012: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 50,822 | $ | 3 | $ | -31 | $ | 50,794 | |||||||||||
Government agency | 32,444 | 10 | -4 | 32,450 | |||||||||||||||
Total marketable investment securites | $ | 83,266 | $ | 13 | $ | -35 | $ | 83,244 | |||||||||||
Marketable investment securities available for sale in an unrealized loss position as of September 30, 2013 and December 31, 2012 are summarized as follows (in thousands): | |||||||||||||||||||
Held for less than 12 months | Held for more than 12 months | Total | |||||||||||||||||
Unrealized | Unrealized | Unrealized | |||||||||||||||||
Fair value | losses | Fair value | losses | Fair value | losses | ||||||||||||||
As of September 30, 2013: | |||||||||||||||||||
Available for Sale: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 76,958 | $ | 45 | $ | - | $ | - | $ | 76,958 | $ | 45 | |||||||
Government agency | 7,828 | 4 | - | - | 7,828 | 4 | |||||||||||||
$ | 84,786 | $ | 49 | $ | - | $ | - | $ | 84,786 | $ | 49 | ||||||||
As of December 31, 2012: | |||||||||||||||||||
Available for Sale: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 37,974 | $ | 31 | $ | - | $ | - | $ | 37,974 | $ | 31 | |||||||
Government agency | 7,110 | 4 | - | - | 7,110 | 4 | |||||||||||||
$ | 45,084 | $ | 35 | $ | - | $ | - | $ | 45,084 | $ | 35 | ||||||||
Summary of Contractual Maturities | |||||||||||||||||||
Maturities of marketable investment securities are as follows at September 30, 2013 and December 31, 2012(in thousands): | |||||||||||||||||||
As of September 30, 2013 | As of December 31, 2012 | ||||||||||||||||||
Amortized | Amortized | ||||||||||||||||||
cost | Fair value | cost | Fair value | ||||||||||||||||
Due within one year | $ | 106,268 | $ | 106,249 | $ | 65,637 | $ | 65,632 | |||||||||||
Due after one year through five years | 25,074 | 25,085 | 17,629 | 17,612 | |||||||||||||||
Due after five years | - | - | - | - | |||||||||||||||
Total debt securities | $ | 131,342 | $ | 131,334 | $ | 83,266 | $ | 83,244 | |||||||||||
Impairments | |||||||||||||||||||
No impairment losses were recognized through earnings related to available for sale securities during the three and nine months ended September 30, 2013 and 2012. | |||||||||||||||||||
Proceeds from Available for Sale Securities | |||||||||||||||||||
The proceeds from maturities and sales of available for sale securities and resulting realized gains and losses, were as follows (in thousands): | |||||||||||||||||||
For the Three Months | For the Nine Months | ||||||||||||||||||
Ended September 30, | Ended September 30, | ||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||
Proceeds from sales and maturities | $ | 18,045 | $ | 22,858 | $ | 64,702 | $ | 79,440 | |||||||||||
Realized gains | - | - | 2 | 3 | |||||||||||||||
Realized losses | - | - | - | - | |||||||||||||||
Inventory_Note_5
Inventory - Note 5 | 9 Months Ended |
Sep. 30, 2013 | |
Inventory Disclosure | ' |
Inventory | ' |
(5) Inventory | |
Inventories, stated at the lower of cost or market, consisted of raw materials of $27.5 million and finished goods of $97,000 as of September 30, 2013. The Company began to capitalize inventory after the FDA approval of Gattex in December 2012. The Company acquired approximately $16.6 million of Revestive raw materials and $17.1 million of PTH raw materials related to the March 18, 2013 Transition and Termination Agreement with Takeda (See note 10). During June 2013, certain lots of this PTH inventory were designated for research and development activities and were accordingly expensed during the period. | |
Longterm_Debt_Note_6
Long-term Debt - Note 6 | 9 Months Ended | ||||||
Sep. 30, 2013 | |||||||
Long-Term Debt Disclosure | ' | ||||||
Long-Term Debt | ' | ||||||
(6) Long-term Debt | |||||||
The following table reflects the carrying value of the Company's long-term debt under various financing arrangements as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||
September 30, | December 31, | ||||||
2013 | 2012 | ||||||
Convertible notes | $ | 16,545 | $ | 16,545 | |||
Non-recourse debt | 139,057 | 159,302 | |||||
Total debt | 155,602 | 175,847 | |||||
Less current portion | 23,215 | 6,278 | |||||
Total long-term debt | $ | 132,387 | $ | 169,569 | |||
(a) Convertible Notes | |||||||
The Company has $16.5 million of its 5.75% Convertible Notes (5.75% Convertible Notes) outstanding as of September 30, 2013. The 5.75% Convertible Notes originated from an August 2007 private placement of $50.0 million in 5.75% Convertible Notes due August 7, 2014. The 5.75% Convertible Notes accrue interest at an annual rate of 5.75% payable quarterly in arrears on the first day of the succeeding calendar quarter commencing January 1, 2008. As of September 30, 2013, the Company classified the 5.75% Convertible Notes as current debt. Accrued interest on the 5.75% Convertible Notes was $0 as of September 30, 2013 and December 31, 2012. The holders may convert all or a portion of the 5.75% Convertible Notes into common stock at any time, subject to certain limitations, on or before August 7, 2014. The 5.75% Convertible Notes are convertible into common stock at a conversion price of $5.44 per share (see below), subject to adjustments in certain events. The 5.75% Convertible Notes are unsecured debt obligations and rank equally in right of payment with all existing and future unsecured senior indebtedness. The 5.75% Convertible Notes provide for certain events of default, including payment defaults, breaches of covenants and certain events of bankruptcy, insolvency and reorganization. The 5.75% Convertible Notes also provide that if there shall occur a fundamental change, as defined, at any time prior to the maturity of the Note, then the holder shall have the right, at the Holder's option, to require the Company to redeem the notes, or any portion thereof plus accrued interest and liquidated damages, if any. If a change of control, as defined, occurs and if the holder converts notes in connection with any such transaction, the Company will pay a make whole premium by increasing the conversion rate applicable to the notes. If any event of default occurs and is continuing, the principal amount of the 5.75% Convertible Notes, plus accrued and unpaid interest, if any, may be declared immediately due and payable. The Company incurred debt issuance costs of approximately $600,000, which have been deferred and which are being amortized over a seven-year period, unless earlier converted, in which case the unamortized costs are recorded in additional paid-in capital. The effective interest rate on the 5.75% Convertible Notes, including debt issuance costs, is 5.9%. | |||||||
Pursuant to the Registration Rights Agreement, the Company has filed a shelf registration statement with the SEC, covering a resale of the common stock issuable upon conversion of the 5.75% Convertible Notes. The registration statement has been declared effective. The Company agreed to use its reasonable best efforts to keep the registration statement effective until the earlier of (i) the date as of which holders may sell all of the securities covered by the registration statement without restriction pursuant to Rule 144(k) promulgated under the Securities Act of 1933 or (ii) the date on which holders shall have sold all of the securities covered by the registration statement. If the Company fails to comply with these covenants or suspends use of the registration statement for periods of time that exceed what is permitted under the Registration Rights Agreement, the Company is required to pay liquidated damages in an amount equivalent to 1% per annum of (a) the principal amount of the notes outstanding, or (b) the conversion price of each underlying share of common stock that has been issued upon conversion of a note, in each case, until the Company is in compliance with these covenants. The Company believes the likelihood of such an event occurring is remote and, as such, the Company has not recorded a liability as of September 30, 2013. | |||||||
(b) Non-recourse Debt | |||||||
Sensipar and Mimpara-Secured Non-recourse Debt | |||||||
As of September 30, 2013 and December 31, 2012, the outstanding principal balances on Sensipar and Mimpara-secured non-recourse debt were $61.1 million and $80.2 million, respectively. The Sensipar and Mimpara-secured debt is non-recourse to the Company and solely secured and serviced by Sensipar and Mimpara (cinacalcet HCl) royalties. The Company amended its agreement with Amgen effective September 30, 2011 whereby Amgen advanced $145.0 million of Sensipar and Mimpara royalties to the Company (Sensipar Notes). The Sensipar Notes accrue interest at an annual rate of 9%, compounded quarterly and payable forty-five days after the close of each quarter. The payment of the royalty advance and discount shall be satisfied solely by Amgen's withholding of royalties and except in the event of a breach of certain customary representations and warranties under the agreement, the Company will have no obligation to repay any unsettled amount. The Company further amended the agreement with Amgen effective June 29, 2012, limiting the royalty offset of the royalty advance up to $8.0 million per quarter with royalties in excess of $8.0 million paid to the Company for the respective quarter, thereby extending the royalty advance repayment period. After the payment of the royalty advance and a 9 percent per annum discount on the balance of the advance, Amgen will resume paying NPS all royalties earned through December 31, 2018. As of September 30, 2013 and December 31, 2012, the Company classified $6.7 million and $6.3 million, respectively, of the Sensipar Notes as current based on royalty payments accrued as of September 30, 2013 and December 31, 2012. Accrued interest on the Sensipar Notes was approximately $665,000 and $874,000 as of September 30, 2013 and December 31, 2012, respectively. The Company incurred debt issuance costs of $96,000, which are being amortized using the effective interest method. The effective interest rate on the Sensipar Notes, including debt issuance costs, is approximately 9%. | |||||||
PTH 1-84-Secured (Europe, CIS and Turkey) Non-recourse Debt | |||||||
As of September 30, 2013 and December 31, 2012, the outstanding principal balances on PTH 1-84-secured (Europe, CIS and Turkey) debt were $42.8 million, respectively. In July 2007, the Company entered into an agreement with DRI Capital, or DRI, formerly Drug Royalty L.P.3, in which the Company sold to DRI its right to receive future royalty payments due under its license agreement with Takeda. Under the agreement, DRI paid the Company an up-front purchase price of $50.0 million. If and when DRI receives two and a half times the amount paid to the Company, the agreement will terminate and the remainder of the royalties, if any, will revert back to the Company. In connection with the Company's July 2007 agreement with DRI, the Company granted DRI a security interest in its license agreement with Takeda for PTH 1-84 (Europe, CIS and Turkey) and certain of its patents and other intellectual property underlying that agreement. In the event of a default by NPS under the agreement with DRI, DRI would be entitled to enforce its security interest against the property described above. The Company determined the initial up-front purchase price is debt and is being amortized using the effective interest method over the estimated life of approximately 14 years. Accrued interest under the DRI agreement was $0 as of September 30, 2013 and December 31, 2012, respectively. As of September 30, 2013, $45.5 million has been paid to DRI. On March 18, 2013, Takeda terminated the license agreement and returned the rights to NPS (See note 10). NPS is obligated to use its commercially reasonable efforts to negotiate, execute and deliver a new license agreement for the licensed technology in the territory on terms similar to the Takeda agreement or any other arrangement for the exploitation of the licensed technology, in each case providing for the payment of royalties or other consideration to the same extent and for the same period of time that royalties are currently payable to DRI. The Company is currently in discussions with DRI regarding the optimal product development strategy for PTH 1-84, which requires DRI's consent. This obligation is required for a period of twelve months following the termination of the Takeda agreement. If the Company does not complete such negotiation, execution and delivery and obtain DRI's consent, during such twelve month period, then DRI has the right to negotiate, execute and deliver a new license agreement for the licensed technology on terms no more extensive (when taken as a whole), without NPS' permission, than the terms contained in the Takeda agreement. The repayment of the remaining $42.8 million is secured solely by future royalty payments arising from sales of the licensed product. The PTH 1-84-secured (Europe, CIS and Turkey) debt is non-recourse to the Company. | |||||||
REGPARA-Secured Non-recourse Debt | |||||||
As of September 30, 2013 and December 31, 2012, the outstanding principal balances on REGPARA-secured debt were $35.2 and $36.3 million, respectively. In February 2010, the Company entered into an agreement with an affiliate of DRI, in which the Company sold to DRI its right to receive future royalty payments arising from sales of REGPARA® (cinacalcet HC1) under its license agreement with Kyowa Hakko Kirin. Under the agreement, DRI paid the Company an upfront purchase price of $38.4 million. If and when DRI receives two and a half times the amount paid to the Company, the agreement will terminate and the remainder of the royalties, if any, will revert back to the Company. In connection with the Company's February 2010 agreement with DRI, the Company granted DRI a security interest in its license agreement with Kyowa Hakko Kirin for REGPARA and certain of its patents and other intellectual property underlying that agreement. In the event of a default by NPS under the agreement with DRI, DRI would be entitled to enforce its security interest against NPS and the property described above. The Company classified the initial upfront purchase price as debt which is being amortized using the effective interest method over the estimated life of approximately 10 years. As of September 30, 2013 and December 31, 2012, the Company classified $0 and $0, respectively, of the REGPARA-secured debt as current based on royalty payments accrued as of September 30, 2013 and December 31, 2012. Accrued interest under the DRI agreement was $0 and $3.1 million as of September 30, 2013 and December 31, 2012, respectively. Through September 30, 2013, $27.9 million has been paid to DRI. The repayment of the remaining $35.2 million principal as of September 30, 2013, is secured solely by future royalty payments arising from sales of REGPARA by Kyowa Hakko Kirin. The effective interest rate under the agreement, including issuance costs, is approximately 16.4%. The REGPARA-secured debt is non-recourse to the Company. | |||||||
Income_Taxes_Note_7
Income Taxes - Note 7 | 9 Months Ended |
Sep. 30, 2013 | |
Income Taxes Disclosure | ' |
Income Taxes | ' |
(7) Income Taxes | |
The Company accounts for penalties or interest related to uncertain tax positions as part of its provision for income taxes. Due to the Company's net operating loss carryforwards, any adjustment related to a liability would not be expected to result in a cash tax liability. Accordingly, the Company has not accrued for penalties or interest for the U.S. (both federal and state) as of September 30, 2013 and December 31, 2012. Assuming the continued existence of a full valuation allowance on the Company's net deferred tax assets, future recognition of any of the Company's unrecognized tax benefits would not impact the effective tax rate. | |
The Company files income tax returns in various jurisdictions with varying statutes of limitations. The statute of limitations for income tax audits in the U.S. will commence upon utilization of net operating losses and will expire three years from the filing of the tax return. In August 2012, the IRS completed its examination of the Company's U.S. federal income tax returns for the year ended December 31, 2009. In May 2013, the State of New Jersey completed its examination of the Company's New Jersey income tax returns through the year ended December 31, 2010. There were no adjustments as a result of these examinations. | |
Commitment_and_Contingencies_N
Commitment and Contingencies - Note 8 | 9 Months Ended |
Sep. 30, 2013 | |
Commitments and Contingencies Disclosure | ' |
Commitments and Contingencies | ' |
(8) Commitments and Contingencies | |
The Company has agreed to indemnify, under certain circumstances, certain manufacturers and service providers from and against any and all losses, claims, damages or liabilities arising from services provided by such manufacturers and service providers or from any use, including clinical trials, or sale by the Company or any Company agent of any product supplied by the manufacturers. The Company has entered into long-term agreements with various third-party contract manufacturers for the production and packaging of the active pharmaceutical ingredient and drug product. Under the terms of these various contracts, the Company may be required to purchase certain minimum quantities of product each year. | |
Stock_Options_Note_9
Stock Options - Note 9 | 9 Months Ended | |||||||||||
Sep. 30, 2013 | ||||||||||||
Stock Option Plans | ' | |||||||||||
(9) Stock Options | ||||||||||||
The Company recognized $2.2 million and $7.3 million of compensation expense during the three and nine months ended September 30, 2013, respectively and $1.4 million and $4.9 million during the three and nine months ended September 30, 2012, respectively, related to all stock based compensation. As of September 30, 2013, there was $18.4 million of total unrecognized compensation cost related to all unvested share-based compensation arrangements that is expected to be recognized over a weighted-average period of 2.64 years. | ||||||||||||
During the year ended December 31, 2010, the Company's Board of Directors awarded a total of 1,130,700 performance condition options to certain of the Company's employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the grant date and the individuals fulfilling a service condition (continued employment). As of September 30, 2013, the performance criteria of 825,340 of these options had been satisfied and will become exercisable based on the following vesting schedule: 25% on each of the first four anniversaries of the date of grant, which was February 20, 2010 (the date of grant). The Company recognized $122,000 and $366,000 of compensation expense during the three and nine months ended September 30, 2013, respectively and $33,000 and $349,000 of compensation expense during the three and nine months ended September 30, 2012, respectively, related to these options. The next performance criteria is the acceptance of the BLA filing for Natpara by the FDA. This acceptance would trigger approximately $111,000 of compensation expense related to these options. The BLA filing for Natpara was submitted to the FDA in October 2013. | ||||||||||||
The Company utilized the Black-Scholes option pricing model to determine the grant date fair value of these awards. As of September 30, 2013, except for the 825,340 options discussed above, the Company does not believe that the achievement of the remaining performance criteria is probable and therefore, has not recognized any compensation expense related to these options during the three and nine months ended September 30, 2013 and 2012, respectively. Compensation expense will be recognized only once the performance condition is probable of being achieved and then only the cumulative amount related to the service condition that has been fulfilled. | ||||||||||||
On May 7, 2013, the Company held its Annual Meeting of Stockholders. At the Annual Meeting, the Company's stockholders approved an amendment to the Company's 2005 Omnibus Incentive Plan to, among other things, increase by 3,500,000 the shares reserved for issuance under the Plan. | ||||||||||||
A summary of activity related to aggregate stock options under all plans is indicated in the following table (in thousands, except per share amounts): | ||||||||||||
As of September 30, 2013 | ||||||||||||
Weighted | Weighted | |||||||||||
Number | average | average remaining | Aggregate | |||||||||
of | exercise | contractual | intrinsic | |||||||||
options | price | term | value | |||||||||
(in thousands) | (in years) | (in thousands) | ||||||||||
Options outstanding at beginning | ||||||||||||
of year | 7,390 | $ | 6.75 | |||||||||
Options granted | 2,107 | 10.18 | ||||||||||
Options exercised | 1,995 | 5.79 | ||||||||||
Options forfeited/expired | 361 | 13.75 | ||||||||||
Options outstanding at September 30, 2013 | 7,141 | 7.67 | 7.57 | $ | 172,323 | |||||||
Vested and expected to vest | 6,676 | 7.53 | 7.47 | $ | 162,085 | |||||||
Options exercisable at September 30, 2013 | 3,138 | $ | 6.40 | 6.01 | $ | 79,723 | ||||||
Takeda_Termination_and_Transit
Takeda Termination and Transition Agreement - Note 10 | 9 Months Ended |
Sep. 30, 2013 | |
Takeda Termination and Transition Agreement Disclosure | ' |
Termination and Transition Agreement | ' |
(10) Takeda Termination and Transition Agreement | |
On March 18, 2013, the Company entered into a Termination and Transition Agreement (the Agreement), with Takeda GmbH (Takeda GmbH), and Takeda Pharma A/S (Takeda Pharma and, together with Takeda GmbH, Takeda). | |
The Agreement provides for the termination of the license agreement, dated July 2, 2007, as amended, which granted Takeda Pharma the exclusive license to sell, market and commercialize recombinant human parathyroid hormone 1-84 [rDNA origin] (rhPTH 1-84) worldwide, except for the U.S., Israel, and Japan, and a non-exclusive license to manufacture and develop rhPTH 1-84 (the rhPTH 1-84 License Agreement). Pursuant to the rhPTH 1-84 License Agreement the rights were returned to the Company without consideration. Preotact is the brand name that Takeda Pharma has used to market rhPTH 1-84 for the treatment of osteoporosis in certain of its licensed territories. The Company is developing rhPTH 1-84 in the U.S. under the trade name Natpara for the treatment of hypoparathyroidism. | |
The Agreement also provides for the termination of the license agreement, dated September 24, 2007, as amended, which granted Takeda GmbH the exclusive license to develop and commercialize teduglutide worldwide, except for North America and Israel (the Revestive License Agreement). Takeda GmbH developed and obtained approval in the EU in August 2012 for teduglutide under the trade name Revestive for the treatment of Short Bowel Syndrome (SBS) in adults. The Company obtained U.S. Food and Drug Administration approval in the U.S. in December 2012 for teduglutide under the trade name Gattex for adult patients with SBS who are dependent on parenteral support. As a result of the termination of the License Agreements, the Company now has the exclusive rights worldwide to develop and commercialize teduglutide and PTH, except as noted in Note 6, whereby DRI would be owed a royalty for sales of PTH in the territory. | |
Takeda assigned to NPS its assets related to the two products, including all of its active pharmaceutical ingredient inventory and information related to the products' continued development, manufacture, and commercialization, including life cycle management assets. Takeda received 6.1 million shares of NPS common stock that were valued at $54.9 million as of the date of the transaction. Takeda will also earn a $30.0 million milestone payment in the first calendar year that combined worldwide net sales of both products exceed $750 million. This milestone includes an early payment trigger upon a qualified change of control. NPS has the option of making this milestone payment in cash or NPS common stock. | |
The Company engaged an independent valuation firm to assist it in determining the fair value of the assets acquired. Using these fair values, the Company assigned $16.6 million to the Revestive active pharmaceutical ingredient (API), $17.1 million to the PTH API and $20.7 million to the Revestive product rights. The Company capitalized the Revestive and PTH API as inventory and capitalized the product rights to intangibles, net on the Company's balance sheet due to the fact that Revestive and Preotact are approved in the EU for SBS and Osteoporosis, respectively. | |
Capital_Stock_Note_11
Capital Stock - Note 11 | 9 Months Ended |
Sep. 30, 2013 | |
Capital Stock Disclosure | ' |
Capital Stock | ' |
(11) Capital Stock | |
In May 2013, the Company completed a public sale of 6,900,000 shares of its common stock at a per share price of $14.53. Net proceeds to the Company from the sale totaled approximately $93.5 million, after deducting expenses and the commission in connection with the offering paid by the Company. | |
Recent_Accounting_Pronouncemen
Recent Accounting Pronouncements - Note 12 | 9 Months Ended |
Sep. 30, 2013 | |
Recent Accounting Pronouncements Disclosure | ' |
Recent Accounting Pronouncements | ' |
(12) Recent Accounting Pronouncements | |
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position, results of operations or disclosures upon adoption. | |
In February 2013, the FASB issued ASU 2013-02 Reporting of Amounts Reclassified out of Accumulated Other Comprehensive Income (ASU 2013-02), an Accounting Standards Update to the Comprehensive Income Topic in the Accounting Standards Codifications (ASC). This update requires separate presentation of the components that are reclassified out of accumulated other comprehensive income either on the face of the financial statements or in the notes to the financial statements. This update also requires companies to disclose the income statement line items impacted by any significant reclassifications, such as the realized gain on marketable investment securities. These items are required for both interim and annual reporting for public companies and became effective for the Company beginning with its quarterly report on Form 10-Q for the period ending March 31, 2013. The Company adopted this ASU on January 1, 2013. The adoption of this ASU did not have a material impact on the Company's financial position or results of operations. | |
Basis_of_Presentation_Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Notes to Financial Statements | ' |
Principles of Consolidation | ' |
The accompanying unaudited condensed consolidated financial statements included herein have been prepared by NPS Pharmaceuticals, Inc. (NPS or the Company) in accordance with the rules and regulations of the United States Securities and Exchange Commission (SEC). The condensed consolidated financial statements are comprised of the financial statements of NPS and its subsidiaries collectively referred to as the Company. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by U.S. generally accepted accounting principles has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2013. | |
These condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2012, included in NPS' 2012 Annual Report on Form 10-K filed with the SEC. | |
Use of Estimates | ' |
The preparation of the condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. generally accepted accounting principles. Actual results could differ from these estimates. | |
Subsequent Events | ' |
The Company has evaluated all events and transactions since September 30, 2013. The Company did not have any material recognized or non-recognized subsequent events. | |
Product Sales | ' |
Product Sales. Product sales represent U.S. sales of Gattex, which was approved by the U.S. Food and Drug Administration (FDA) in December 2012. The Company recognizes revenue from Gattex product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer is reasonably assured, the Company has no further performance obligations, and returns can be reasonably estimated. | |
All prescriptions for Gattex, received directly by NPS from the patient's physician, are handled through NPS Advantage, the Company's data management and patient support program, which investigates and determines the patient's insurance coverage for Gattex. Once coverage is confirmed, NPS forwards the prescription to the specialty pharmacy (SP) who then re-confirms the coverage and dispenses Gattex to the patient. The Company sells Gattex directly to a limited number of SPs and a specialty distributor (SD) who dispense product to patients, hospitals or U.S. government entities. The Company invoices and records revenue when the SPs or SD receives Gattex from the Company's third-party logistics warehouse. The Company's SPs order product to fill prescriptions that have been approved for reimbursement by payers. | |
Specific considerations for Gattex sold in the U.S. are as follows: | |
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. The allowance for rebates is based on statutory discount rates and expected utilization. The Company's estimate for expected utilization for rebates is based in part on actual and pending prescriptions for which it has validated the insurance benefits. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase from the Company's SPs or SD. Contracted customers, which currently consist primarily of Public Health Service institutions and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The Company's SPs or SD, in turn, charge back the difference between the price initially paid by the SP or SD and the discounted price paid to the SP or SD by the customer. The allowance for chargebacks is based on actual and expected sales to the SPs and SD. | |
SP and SD Fees and Deductions: The Company's SPs and its SD are offered prompt payment discounts and are paid fees for their services and data. | |
Product returns: The Company will accept product that is damaged or defective when shipped directly to the SP or SD from the Company's third-party logistics provider or for product that is returned with more than two (2) months remaining until the expiration date from its SP or SD only. The Company will not provide any credit for product that has been labeled for or sent to a patient. Product returned is generally not resalable as the product must be temperature-controlled throughout the supply chain and such control is difficult to confirm. The Company makes a reasonable estimate of future potential product returns based on the number of prescriptions that have been approved for reimbursement and sent to an SP with each corresponding shipment of Gattex that has been sent to each respective SP. The Company also has the visibility to see current inventory levels and the current shelf life at the SPs and SD and has the ability to control the amount of product that is sold to the SPs and SD. At the end of each reporting period, the Company determines a product returns reserve by evaluating the units held in its distribution channel, the underlying demand for such units and the risk of potential product returns. At September 30, 2013 the Company recorded a product returns reserve of approximately $119,000 that it believes could be returned in the future. | |
Product sales are recorded net of accruals for estimated rebates, chargebacks, discounts, and other deductions (collectively, sales deductions) and returns. With the exception of allowances for prompt payment, allowances for sales deductions and returns are included in accounts payable and accrued expenses in the accompanying consolidated balance sheets. | |
Inventory | ' |
Inventory. Inventories are stated at the lower of cost or estimated realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products after regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes-down such inventories as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to cost of goods sold to write down such unmarketable inventory to its estimated realizable value. | |
Income (Loss) per Common Share | ' |
Basic net income (loss) per common share is the amount of income (loss) for the period divided by the weighted average shares of common stock outstanding during the reporting period. Diluted income (loss) per common share is the amount of income (loss) for the period plus interest expense on convertible debt divided by the sum of weighted average shares of common stock outstanding during the reporting period and weighted average shares that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares. | |
Fair Value of Financial Instruments | ' |
The Company's financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. The three levels are as follows: | |
Level 1- Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. | |
Level 2- Inputs are other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). | |
Level 3- Inputs are unobservable and reflect the Company's assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available. | |
The fair values of the Company's convertible notes were estimated using the (i) terms of the convertible notes; (ii) rights, preferences, privileges, and restrictions of the underlying security; (iii) time until any restriction(s) are released; (iv) fundamental financial and other characteristics of the Company; (v) trading characteristics of the underlying security (exchange, volume, price, and volatility); and (vi) precedent sale transactions. The fair values of the Company's non-recourse Sensipar notes, PTH 1-84 (Europe, Commonwealth of Independent States (CIS) and Turkey)-secured debt and Regpara-secured debt were estimated using a discounted cash flow model. Within the hierarchy of fair value measurements, these are Level 3 fair values. | |
Income Taxes | ' |
The Company accounts for penalties or interest related to uncertain tax positions as part of its provision for income taxes. Due to the Company's net operating loss carryforwards, any adjustment related to a liability would not be expected to result in a cash tax liability. Accordingly, the Company has not accrued for penalties or interest for the U.S. (both federal and state) as of September 30, 2013 and December 31, 2012. Assuming the continued existence of a full valuation allowance on the Company's net deferred tax assets, future recognition of any of the Company's unrecognized tax benefits would not impact the effective tax rate. | |
Fair_Value_Measurement_Tables
Fair Value Measurement (Tables) | 9 Months Ended | ||||||||||||||
Sep. 30, 2013 | |||||||||||||||
Notes to Financial Statements | ' | ||||||||||||||
Fair Value Measurement (Tables) | ' | ||||||||||||||
In accordance with the fair value hierarchy described above, the following table shows the fair value of the Company's financial assets (only marketable investment securities) that are required to be measured at fair value as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||||||||||
As of September 30, 2013: | Level 1 | Level 2 | Level 3 | Total | |||||||||||
Marketable investment securities | $ | 120,618 | $ | 10,716 | $ | - | $ | 131,334 | |||||||
As of December 31, 2012: | Level 1 | Level 2 | Level 3 | Total | |||||||||||
Marketable investment securities | $ | 67,723 | $ | 15,521 | $ | - | $ | 83,244 | |||||||
Fair and Carrying Value of Debt Instruments | ' | ||||||||||||||
The fair and carrying value of our debt instruments are detailed as follows (in thousands): | |||||||||||||||
As of September 30, 2013 | As of December 31, 2012 | ||||||||||||||
Fair | Carrying | Fair | Carrying | ||||||||||||
Value | Value | Value | Value | ||||||||||||
5.75% Convertible Notes | $ | 96,748 | $ | 16,545 | $ | 28,131 | $ | 16,545 | |||||||
Sensipar Notes | 60,588 | 61,065 | 79,129 | 80,234 | |||||||||||
PTH 1-84 (Europe, CIS and Turkey) | |||||||||||||||
-Secured Debt | 27,597 | 42,790 | 28,605 | 42,816 | |||||||||||
Regpara-Secured Debt | 38,661 | 35,202 | 48,887 | 36,252 | |||||||||||
Total | $ | 223,594 | $ | 155,602 | $ | 184,752 | $ | 175,847 | |||||||
Financial_Instruments_Tables
Financial Instruments (Tables) | 9 Months Ended | ||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||
Notes to Financial Statements | ' | ||||||||||||||||||
Marketable investment securities | ' | ||||||||||||||||||
The following is a summary of the Company's marketable investment securities (in thousands): | |||||||||||||||||||
Gross | Gross | ||||||||||||||||||
unrealized | unrealized | ||||||||||||||||||
Amortized | holding | holding | Fair | ||||||||||||||||
cost | gains | losses | value | ||||||||||||||||
As of September 30, 2013: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 94,058 | $ | 19 | $ | -45 | $ | 94,032 | |||||||||||
Government agency | 37,284 | 22 | -4 | 37,302 | |||||||||||||||
Total marketable investment securites | $ | 131,342 | $ | 41 | $ | -49 | $ | 131,334 | |||||||||||
Gross | Gross | ||||||||||||||||||
unrealized | unrealized | ||||||||||||||||||
Amortized | holding | holding | Fair | ||||||||||||||||
cost | gains | losses | value | ||||||||||||||||
As of December 31, 2012: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 50,822 | $ | 3 | $ | -31 | $ | 50,794 | |||||||||||
Government agency | 32,444 | 10 | -4 | 32,450 | |||||||||||||||
Total marketable investment securites | $ | 83,266 | $ | 13 | $ | -35 | $ | 83,244 | |||||||||||
Marketable investment securities available for sale in an unrealized loss position | ' | ||||||||||||||||||
Marketable investment securities available for sale in an unrealized loss position as of September 30, 2013 and December 31, 2012 are summarized as follows (in thousands): | |||||||||||||||||||
Held for less than 12 months | Held for more than 12 months | Total | |||||||||||||||||
Unrealized | Unrealized | Unrealized | |||||||||||||||||
Fair value | losses | Fair value | losses | Fair value | losses | ||||||||||||||
As of September 30, 2013: | |||||||||||||||||||
Available for Sale: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 76,958 | $ | 45 | $ | - | $ | - | $ | 76,958 | $ | 45 | |||||||
Government agency | 7,828 | 4 | - | - | 7,828 | 4 | |||||||||||||
$ | 84,786 | $ | 49 | $ | - | $ | - | $ | 84,786 | $ | 49 | ||||||||
As of December 31, 2012: | |||||||||||||||||||
Available for Sale: | |||||||||||||||||||
Debt securities: | |||||||||||||||||||
Corporate | $ | 37,974 | $ | 31 | $ | - | $ | - | $ | 37,974 | $ | 31 | |||||||
Government agency | 7,110 | 4 | - | - | 7,110 | 4 | |||||||||||||
$ | 45,084 | $ | 35 | $ | - | $ | - | $ | 45,084 | $ | 35 | ||||||||
Maturities of marketable investment securities | ' | ||||||||||||||||||
Summary of Contractual Maturities | |||||||||||||||||||
Maturities of marketable investment securities are as follows at September 30, 2013 and December 31, 2012(in thousands): | |||||||||||||||||||
As of September 30, 2013 | As of December 31, 2012 | ||||||||||||||||||
Amortized | Amortized | ||||||||||||||||||
cost | Fair value | cost | Fair value | ||||||||||||||||
Due within one year | $ | 106,268 | $ | 106,249 | $ | 65,637 | $ | 65,632 | |||||||||||
Due after one year through five years | 25,074 | 25,085 | 17,629 | 17,612 | |||||||||||||||
Due after five years | - | - | - | - | |||||||||||||||
Total debt securities | $ | 131,342 | $ | 131,334 | $ | 83,266 | $ | 83,244 | |||||||||||
Proceeds from maturities and sales of available for sale securities and resulting gain and losses | ' | ||||||||||||||||||
The proceeds from maturities and sales of available for sale securities and resulting realized gains and losses, were as follows (in thousands): | |||||||||||||||||||
For the Three Months | For the Nine Months | ||||||||||||||||||
Ended September 30, | Ended September 30, | ||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||
Proceeds from sales and maturities | $ | 18,045 | $ | 22,858 | $ | 64,702 | $ | 79,440 | |||||||||||
Realized gains | - | - | 2 | 3 | |||||||||||||||
Realized losses | - | - | - | - | |||||||||||||||
Longterm_Debt_Tables
Long-term Debt (Tables) | 9 Months Ended | ||||||
Sep. 30, 2013 | |||||||
Notes to Financial Statements | ' | ||||||
Long-term Debt (Tables) | ' | ||||||
The following table reflects the carrying value of the Company's long-term debt under various financing arrangements as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||
September 30, | December 31, | ||||||
2013 | 2012 | ||||||
Convertible notes | $ | 16,545 | $ | 16,545 | |||
Non-recourse debt | 139,057 | 159,302 | |||||
Total debt | 155,602 | 175,847 | |||||
Less current portion | 23,215 | 6,278 | |||||
Total long-term debt | $ | 132,387 | $ | 169,569 | |||
Stock_Options_Tables
Stock Options (Tables) | 9 Months Ended | |||||||||||
Sep. 30, 2013 | ||||||||||||
Stock Options Tables | ' | |||||||||||
Disclosure Of Share-Based Compensation Arrangements By Share-Based Payment Award | ' | |||||||||||
A summary of activity related to aggregate stock options under all plans is indicated in the following table (in thousands, except per share amounts): | ||||||||||||
As of September 30, 2013 | ||||||||||||
Weighted | Weighted | |||||||||||
Number | average | average remaining | Aggregate | |||||||||
of | exercise | contractual | intrinsic | |||||||||
options | price | term | value | |||||||||
(in thousands) | (in years) | (in thousands) | ||||||||||
Options outstanding at beginning | ||||||||||||
of year | 7,390 | $ | 6.75 | |||||||||
Options granted | 2,107 | 10.18 | ||||||||||
Options exercised | 1,995 | 5.79 | ||||||||||
Options forfeited/expired | 361 | 13.75 | ||||||||||
Options outstanding at September 30, 2013 | 7,141 | 7.67 | 7.57 | $ | 172,323 | |||||||
Vested and expected to vest | 6,676 | 7.53 | 7.47 | $ | 162,085 | |||||||
Options exercisable at September 30, 2013 | 3,138 | $ | 6.40 | 6.01 | $ | 79,723 | ||||||
Basis_of_Presentation_Product_
Basis of Presentation (Product Returns Narrative) (Details) (USD $) | Sep. 30, 2013 |
Basis Of Presentation Product Returns Narrative Details | ' |
Allowance for product returns | $119,000 |
Income_Loss_Per_Share_Narrativ
Income (Loss) Per Share (Narrative) (Details) | 3 Months Ended | 9 Months Ended | ||
In Millions, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Anti-dilutive shares | 7.4 | 6.7 | 6.7 | 8.9 |
Convertible Notes Payable | ' | ' | ' | ' |
Anti-dilutive shares | 3 | 3 | 3 | 3 |
Stock Options Restricted Stock And Restricted Stock Units | ' | ' | ' | ' |
Anti-dilutive shares | 4.4 | 4.9 | 3.6 | 4.8 |
Fair_Value_Measurement_Securit
Fair Value Measurement (Securities) (Details 1) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Marketable investment securities | $131,334 | $83,244 |
Level 1 | ' | ' |
Marketable investment securities | 120,618 | 67,723 |
Level 2 | ' | ' |
Marketable investment securities | 10,716 | 15,521 |
Level 3 | ' | ' |
Marketable investment securities | $0 | $0 |
Fair_Value_Measurement_Debt_In
Fair Value Measurement (Debt Instruments) (Details 2) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Debt instruments, fair value | $223,594 | $184,752 |
Debt instruments, carrying value | 155,602 | 175,847 |
Convertible Notes | ' | ' |
Debt instruments, fair value | 96,718 | 28,131 |
Debt instruments, carrying value | 16,545 | 16,545 |
Sensipar Notes | ' | ' |
Debt instruments, fair value | 60,588 | 79,129 |
Debt instruments, carrying value | 61,065 | 80,234 |
PTH 1-84-(Europe, CIS and Turkey)-Secured Debt | ' | ' |
Debt instruments, fair value | 27,597 | 28,605 |
Debt instruments, carrying value | 42,790 | 42,816 |
Regpara-Secured Debt | ' | ' |
Debt instruments, fair value | 38,661 | 48,887 |
Debt instruments, carrying value | $35,202 | $36,252 |
Fair_Value_Measurement_Liabili
Fair Value Measurement (Liabilities Narrative) (Details 3) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Millions, unless otherwise specified | ||
Fair Value Measurement Liabilities Narrative Details 3 | ' | ' |
Brigham Women's Hospital royalty liability, fair value | $4.20 | $4.80 |
Brigham Women's Hospital royalty liability, carrying value | $5.60 | $6.60 |
Financial_Instruments_Fair_Val
Financial Instruments (Fair Value Of Investments) (Details 1) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Amortized cost | $131,342 | $83,266 |
Gross unrealized holding gains | 41 | 13 |
Gross unrealized holding losses | -49 | -35 |
Fair value | 131,334 | 83,244 |
Corporate | ' | ' |
Amortized cost | 94,058 | 50,822 |
Gross unrealized holding gains | 19 | 3 |
Gross unrealized holding losses | -45 | -31 |
Fair value | 94,032 | 50,794 |
Government agency | ' | ' |
Amortized cost | 37,284 | 32,444 |
Gross unrealized holding gains | 22 | 10 |
Gross unrealized holding losses | -4 | -4 |
Fair value | $37,302 | $32,450 |
Financial_Instruments_Fair_Val1
Financial Instruments (Fair Value Of Investments) (Details 2) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Marketable investment securities available for sale in an unrealized loss position | ' | ' |
In Loss Position for Less Than 12 Months, Fair Value | $84,786 | $45,084 |
In Loss Position for Less Than 12 Months, Gross Unrealized Losses | 49 | 35 |
In Loss Position for More Than 12 Months, Fair Value | 0 | 0 |
In Loss Position for More Than 12 Months, Gross Unrealized Losses | 0 | 0 |
Total, Fair Value | 84,786 | 45,084 |
Total, Gross Unrealized Losses | 49 | 35 |
Corp | ' | ' |
Marketable investment securities available for sale in an unrealized loss position | ' | ' |
In Loss Position for Less Than 12 Months, Fair Value | 76,958 | 37,974 |
In Loss Position for Less Than 12 Months, Gross Unrealized Losses | 45 | 31 |
In Loss Position for More Than 12 Months, Fair Value | 0 | 0 |
In Loss Position for More Than 12 Months, Gross Unrealized Losses | 0 | 0 |
Total, Fair Value | 76,958 | 37,974 |
Total, Gross Unrealized Losses | 45 | 31 |
Gov Agency | ' | ' |
Marketable investment securities available for sale in an unrealized loss position | ' | ' |
In Loss Position for Less Than 12 Months, Fair Value | 7,828 | 7,110 |
In Loss Position for Less Than 12 Months, Gross Unrealized Losses | 4 | 4 |
In Loss Position for More Than 12 Months, Fair Value | 0 | 0 |
In Loss Position for More Than 12 Months, Gross Unrealized Losses | 0 | 0 |
Total, Fair Value | 7,828 | 7,110 |
Total, Gross Unrealized Losses | $4 | $4 |
Financial_Instruments_Contract
Financial Instruments (Contractual Maturities) (Details 3) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Financial Instruments Contractual Maturities Details 3 | ' | ' |
Due within one year, amortized cost | $106,268 | $65,637 |
Due after one year through five years, amortized cost | 25,074 | 17,629 |
Due after five years through ten years, amortized cost | 0 | 0 |
Due after ten years, amortized cost | 0 | 0 |
Due within one year, fair value | 65,637 | 65,632 |
Due after one year through five years, fair value | 17,629 | 17,612 |
Due after five years through ten years, fair value | 0 | ' |
Due after ten years, fair value | 0 | ' |
Total debt securities, amortized cost | 131,342 | 83,266 |
Total debt securities, fair value | $131,334 | $83,244 |
Financial_Instruments_Proceeds
Financial Instruments (Proceeds) (Details 4) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Financial Instruments Proceeds Details 4 | ' | ' | ' | ' |
Proceeds from sales and maturities | $18,045 | $22,858 | $64,702 | $79,440 |
Realized gains | 0 | 0 | 2 | 3 |
Realized losses | $0 | $0 | $0 | $0 |
Financial_Instruments_Narrativ
Financial Instruments (Narrative) (Details 5) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Financial Instruments Narrative Details 5 | ' | ' | ' | ' |
Impairment losses | $0 | $0 | $0 | $0 |
Inventory_Narrative_Details
Inventory (Narrative) (Details) (USD $) | Sep. 30, 2013 | Mar. 31, 2013 |
Inventory Narrative Details | ' | ' |
Revestive raw materials | $16,600,000 | $16,600,000 |
PTH raw materials | 17,100,000 | 17,100,000 |
Total raw materials | 27,500,000 | ' |
Finished goods | $97,000 | ' |
Longterm_Debt_Details_1
Long-term Debt (Details 1) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Long-Term Debt Details 1 | ' | ' |
Convertible notes | $16,545 | $16,545 |
Non-recourse debt | 139,057 | 159,302 |
Total debt | 155,602 | 175,847 |
Less current portion | 23,215 | 6,278 |
Total long-term debt | $132,387 | $169,569 |
Longterm_Debt_Narrative_Detail
Long-term Debt (Narrative) (Details 2) (USD $) | 9 Months Ended | |
In Millions, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Convertible Notes | ' | ' |
Debt outstanding | $16.50 | $16.50 |
Debt classified as current | 16.5 | ' |
Month and year of issue | 31-Aug-07 | ' |
Number of interest payments, per year | ' | '4 |
Effective interest rate | ' | 5.90% |
Debt amount originally issued | ' | 50 |
Net proceeds upon original issuance | ' | 49.4 |
Deferred debt issuance costs amortization period, in years | ' | '7 years |
Interest accrued | 0 | 0 |
Debt due date | 'August 7, 2014 | ' |
Conversion price of 5.75% convertible notes, per share | $5.44 | ' |
Sensipar and Mimpara-Secured Non-recourse Debt Sensipar Notes | ' | ' |
Debt outstanding | 61.1 | 80.2 |
Debt classified as current | 6.7 | 6.3 |
Month and year of issue | 30-Sep-11 | ' |
Month and year of amendment | 'June 2012 | ' |
Interest rate | ' | 9.00% |
Effective interest rate | ' | 9.00% |
Debt amount originally issued | ' | 145 |
Net proceeds upon original issuance | ' | 144.9 |
Interest accrued | 0.7 | 0.9 |
Quarterly limit of royalty offset of the royalty advance | 8 | ' |
PTH 1-84-Secured (Europe, CIS and Turkey)Non-recourse Debt | ' | ' |
Debt outstanding | 42.8 | 42.8 |
Month and year of issue | 31-Jul-07 | ' |
Debt amount originally issued | ' | 50 |
Net proceeds upon original issuance | ' | 50 |
Interest accrued | 0 | 0 |
Interest and principal paid to date | ' | 45.5 |
REGPARA-Secured Non-recourse Debt | ' | ' |
Debt outstanding | 35.2 | 36.3 |
Debt classified as current | 0 | 0 |
Month and year of issue | 28-Feb-10 | ' |
Interest rate | ' | 16.40% |
Effective interest rate | ' | 16.40% |
Debt amount originally issued | ' | 38.4 |
Net proceeds upon original issuance | ' | 38.4 |
Deferred debt issuance costs amortization period, in years | ' | '10 years |
Interest accrued | 0 | 3.1 |
Interest and principal paid to date | ' | $27.90 |
Income_Taxes_Narrative_of_Expe
Income Taxes (Narrative of Expense) (Details) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Income Taxes Narrative Of Expense Details | ' | ' |
Accrued penalties and interest | $0 | $0 |
Other Information Pertaining to Income Taxes | ' | ' |
The Company files income tax returns in various jurisdictions with varying statutes of limitations. The statute of limitations for income tax audits in the U.S. will commence upon utilization of net operating losses and will expire three years from the filing of the tax return. In August 2012, the IRS completed its examination of the Company's U.S. federal income tax returns for the year ended December 31, 2009. In May 2013, the State of New Jersey completed its examination of the Company's New Jersey income tax returns through the year ended December 31, 2010. There were no adjustments as a result of these examinations. | ||
Stock_Options_Compensation_Exp
Stock Options (Compensation Expense Narrative) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Millions, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Stock Options Compensation Expense Narrative Details | ' | ' | ' | ' |
Compensation expense on share-based awards | $2.20 | $1.40 | $7.30 | $4.90 |
Unrecognized compensation cost | $18.40 | ' | $18.40 | ' |
Weighted average period over which unrecognized compensation is expected to be recognized, in years | ' | ' | '2 years 7 months 20 days | ' |
Stock_Options_Performance_Cond
Stock Options (Performance Conditions Options Narrative) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Share-based Compensation Expense | $2,200,000 | $1,400,000 | $7,300,000 | $4,900,000 |
Performance Condition Options | ' | ' | ' | ' |
Description of award | ' | ' | ' | ' |
During the year ended December 31, 2010, the Company's Board of Directors awarded a total of 1,130,700 performance condition options to certain of the Company's employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the grant date and the individuals fulfilling a service condition (continued employment). As of June 30, 2013, the performance criteria of 825,340 of these options had been satisfied and will become exercisable based on the following vesting schedule: 25% on each of the first four anniversaries of the date of grant, which was February 20, 2010 (the date of grant). The Company recognized $83,000 and $244,000 of compensation expense during the three and six months ended June 30, 2013, respectively and $32,000 and $316,000 of compensation expense during the three and six months ended June 30, 2012, respectively, related to these options. The next performance criteria is the acceptance of the BLA filing for Natpara by the FDA. This acceptance would trigger approximately $98,000 of compensation expense related to these options. | ||||
The Company utilized the Black-Scholes option pricing model to determine the grant date fair value of these awards. As of June 30, 2013, except for the 825,340 options discussed above, the Company does not believe that the achievement of the remaining performance criteria is probable and therefore, has not recognized any compensation expense related to these options during the three and six months ended June 30, 2013 and 2012, respectively. Compensation expense will be recognized only once the performance condition is probable of being achieved and then only the cumulative amount related to the service condition that has been fulfilled. | ||||
On May 7, 2013, the Company held its Annual Meeting of Stockholders. At the Annual Meeting, the Company's stockholders approved an amendment to the Company's 2005 Omnibus Incentive Plan to, among other things, increase by 3,500,000 the shares reserved for issuance under the Plan. | ||||
Share-based Compensation Expense | $83,000 | $11,000 | $244,000 | $11,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,130,700 | ' | 1,130,700 | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | ' | ' | ' | 3,500,000 |
Stock_Options_Aggregate_Activi
Stock Options (Aggregate Activity Under Stock Option Plans) (Details) (USD $) | 9 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 |
Stock Options Aggregate Activity Under Stock Option Plans Details | ' |
Options outstanding at beginning of year | 7,390,000 |
Options granted | 2,107,000 |
Options exercised | 1,995,000 |
Options forfeited/expired | 361,000 |
Options outstanding at September 30, 2013 | 7,141,000 |
Weighted-average exercise price of options outstanding, beginning of year | $6.75 |
Weighted-average exercise price of options granted during period | $10.18 |
Weighted-average exercise price of options exercised during the period | $5.79 |
Weighted-average exercise price of options forfeited/expired during the period | $13.75 |
Weighted-average exercise price of options outstanding, at June 30, 2013 | $7.67 |
Weighted-average remaining contractual term of options outstanding, at September 30, 2013 | '7 years 6 months 25 days |
Aggregate intrinsic value of options outstanding, at September 30, 2013 | $172,323 |
Options Vested and Expected to Vest, Number of Shares | 6,676,000 |
Options Vested and Expected to Vest, Weighted-Average Exercise Price Per Share | $7.53 |
Options Vested and Expected to Vest, Weighted-Average Remaining Contractual Term | '7 years 5 months 19 days |
Options Vested and Expected to Vest, Aggregate Intrinsic Value | 162,085 |
Options Exercisable, Number of Shares | 3,614,000 |
Options Exercisable, Weighted-Average Exercise Price Per Share | $6.40 |
Options Exercisable, Weighted-Average Remaining Contractual Term | '6 years 0 months 4 days |
Options Exercisable, Aggregate Intrinsic Value | $79,723 |
Takeda_Termination_and_Transit1
Takeda Termination and Transition Agreement (Narrative) (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Mar. 31, 2013 | |
Takeda Termination And Transition Agreement Narrative Details | ' | ' |
Shares of Common Stock issued | 6,100,000 | ' |
Value of Common Stock issued | $54,900,000 | ' |
Future milestone payment in cash or common stock | 30,000,000 | ' |
Milestone payment trigger amount on worldwide net sales | 750,000,000 | ' |
Assets acquired: | ' | ' |
Revestive raw materials | 16,600,000 | 16,600,000 |
PTH raw materials | 17,100,000 | 17,100,000 |
Revestive product rights | $20,700,000 | ' |
Capital_Stock_Narrative_Detail
Capital Stock (Narrative) (Details) (USD $) | 9 Months Ended |
In Millions, except Share data, unless otherwise specified | Sep. 30, 2013 |
Capital Stock Narrative Details | ' |
Stock Issued During Period, Shares, New Issues | 6,900,000 |
Stock Issued During Period, Per Share, New Issues | $14.53 |
Stock Issued During Period, Value, New Issues | $93.50 |