BASIS OF PRESENTATION AND ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2014 |
Accounting Policies [Abstract] | ' |
Basis of Presentation and Consolidation | ' |
Basis of Presentation and Consolidation |
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The accompanying condensed consolidated financial statements are unaudited and have been prepared by Cubist Pharmaceuticals, Inc. ("we," "our," or "us") in accordance with accounting principles generally accepted in the United States of America (GAAP) and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. The year-end condensed consolidated financial statements were derived from audited financial statements, but certain information and footnote disclosures required by GAAP normally included in our annual consolidated financial statements have been condensed or omitted. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements, which are contained in our Annual Report on Form 10-K for the year ended December 31, 2013 (2013 Form 10-K), filed with the Securities and Exchange Commission (SEC) on February 25, 2014. The condensed consolidated financial statements, in the opinion of management, reflect all normal and recurring adjustments necessary for a fair statement of our financial position and results of operations. Certain reclassifications have been made to prior year amounts to conform to the current year presentation. Also, included in prepaid expenses and other current assets, and other assets on our condensed consolidated balance sheet are $1.4 million and $0.7 million, respectively, of restricted cash as of September 30, 2014. |
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The accompanying condensed consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Our results of operations for the three and nine months ended September 30, 2014, include the effects of our acquisitions of Optimer Pharmaceuticals, Inc. (Optimer), and Trius Therapeutics, Inc. (Trius), which we acquired in October 2013 and September 2013, respectively. In addition, our results of operations for the three and nine months ended September 30, 2013, include the results of Trius from September 11, 2013, the date of acquisition. |
Use of Estimates | ' |
Use of Estimates |
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The preparation of financial statements in conformity with GAAP requires extensive use of estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. The most significant assumptions are employed in estimates used in determining the values of: inventory; investments; acquisition-date fair value and subsequent fair value estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (IPR&D) and other intangible assets; accrued clinical research costs; contingent consideration; income taxes; stock-based compensation; product rebate, chargeback and return accruals; as well as in estimates used in accounting for contingencies and revenue recognition. Actual results could differ from these estimates. |
Concentration of Risk | ' |
Concentration of Risk |
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Our accounts receivable as of September 30, 2014 and December 31, 2013, primarily represent amounts due to us from wholesalers, including AmerisourceBergen Drug Corporation, Cardinal Health, Inc. and McKesson Corporation. We perform ongoing credit evaluations of our key wholesalers, distributors and other customers, and generally do not require collateral. For the three and nine months ended September 30, 2014 and 2013, we did not have any significant write-offs of accounts receivable, and our days sales outstanding has not significantly changed since December 31, 2013. |
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| Percentage of Total Accounts Receivable Balance as of | | | | | | | | | | | | |
| September 30, 2014 | | December 31, 2013 | | | | | | | | | | | | |
AmerisourceBergen Drug Corporation | 17% | | 18% | | | | | | | | | | | | |
Cardinal Health, Inc. | 18% | | 17% | | | | | | | | | | | | |
McKesson Corporation | 22% | | 18% | | | | | | | | | | | | |
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| Percentage of Total Net Revenues for the Three Months Ended September 30, | | Percentage of Total Net Revenues for the Nine Months Ended September 30, | | | | | | | | |
| 2014 | | 2013 | | 2014 | | 2013 | | | | | | | | |
AmerisourceBergen Drug Corporation | 18% | | 18% | | 17% | | 19% | | | | | | | | |
Cardinal Health, Inc. | 16% | | 17% | | 17% | | 17% | | | | | | | | |
McKesson Corporation | 21% | | 18% | | 19% | | 18% | | | | | | | | |
IPR&D | ' |
IPR&D |
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IPR&D acquired in a business combination is capitalized on our condensed consolidated balance sheets at its acquisition-date fair value, net of any accumulated impairment losses. Until the underlying project is completed, these assets are accounted for as indefinite-lived intangible assets, subject to impairment testing. Once the project is completed, the carrying value of the intangible asset is amortized over its estimated useful life. Post-acquisition research and development expenses related to the acquired IPR&D are expensed as incurred. |
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IPR&D is tested for impairment on an annual basis, or more frequently if impairment indicators are present. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to its revised fair value with the related impairment charge recognized in the period in which the impairment occurs. If the fair value of the asset becomes impaired as the result of unfavorable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any other information regarding the prospects of successfully developing or commercializing our product candidates, we could incur significant charges in the period in which the impairment occurs. The valuation techniques utilized in performing impairment tests incorporate significant assumptions and judgments to estimate the fair value, and the use of different valuation techniques or different assumptions could result in materially different fair value estimates. |
Revenue Recognition | ' |
Revenue Recognition |
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Our principal sources of revenue during the periods presented were: (i) product revenues of CUBICIN® (daptomycin for injection), DIFICID® (fidaxomicin) and ENTEREG® (alvimopan) in the United States (U.S.); (ii) revenues derived from sales of CUBICIN and DIFICID by our international distribution partners; (iii) license fees and milestone payments that are derived from collaboration, license and commercialization agreements with other biopharmaceutical companies; and (iv) prior to our acquisition of Optimer, service revenues derived from our co-promotion agreement with Optimer for the promotion and support of DIFICID in the U.S., which was terminated on October 24, 2013, as a result of our acquisition of Optimer. Product revenue amounts exclude sales of DIFICID prior to our acquisition of Optimer. The U.S. Food and Drug Administration (FDA) approved SIVEXTRO® (tedizolid phosphate) in the U.S. on June 20, 2014, for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). We commercially launched SIVEXTRO in the U.S. at the end of the second quarter of 2014. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, and collectibility of the resulting receivable is reasonably assured. |
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U.S. Product Revenues, net |
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All revenues from product sales are recorded net of applicable provisions and allowances in the same period the related sales are recorded. |
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Gross U.S. product revenues were offset by provisions for the three and nine months ended September 30, 2014 and 2013, as follows: |
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2014 | | 2013 | | 2014 | | 2013 |
| (in thousands) |
Gross U.S. product revenues | $ | 350,471 | | | $ | 277,999 | | | $ | 954,586 | | | $ | 796,217 | |
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Provisions offsetting U.S. product revenues: | | | | | | | |
Contractual adjustments | (21,443 | ) | | (13,249 | ) | | (63,262 | ) | | (43,281 | ) |
Governmental rebates | (37,145 | ) | | (21,154 | ) | | (93,724 | ) | | (56,589 | ) |
Total provisions offsetting product revenues | (58,588 | ) | | (34,403 | ) | | (156,986 | ) | | (99,870 | ) |
U.S. product revenues, net | $ | 291,883 | | | $ | 243,596 | | | $ | 797,600 | | | $ | 696,347 | |
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Certain of our product sales qualify for rebates or discounts from standard list pricing due to contractual agreements or government-sponsored programs. Our contractual adjustments include provisions for returns, pricing and early payment discounts extended to our external customers, as well as wholesaler distribution fees, and other commercial rebates. Our governmental rebates represent estimated amounts for government-mandated rebates and discounts relating to federal and state programs, such as Medicaid, the Veterans' Administration and Department of Defense (DoD) programs, the Medicare Part D Coverage Gap Discount Program and certain other qualifying federal and state government programs. Estimates and assumptions for reserves are analyzed quarterly. We reversed approximately $6.0 million and $14.1 million of revenue reserves during the three and nine months ended September 30, 2013, respectively, primarily consisting of Medicaid program rebates as a result of receiving claims information from certain state governments and additional data regarding the usage of CUBICIN by managed care organizations. |
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International Product Revenues |
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Sales with international distribution partners are based upon contractually predetermined transfer price arrangements. Once our distribution partner sells the product to a third party, we may also be owed an additional payment or royalty. Certain agreements with our distribution partners contain multiple elements in which we have continuing performance obligations. In arrangements for which we determine that the undelivered elements cannot be separated from the delivered elements, payments from distribution partners for product are recorded as deferred revenue and amortized to international product revenues over the remaining performance obligation. |
Basic and Diluted Net Income (loss) Per Share | ' |
Basic and Diluted Net Income (Loss) Per Share |
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Basic net income (loss) per common share has been computed by dividing net income (loss) by the weighted average number of shares outstanding during the period. Diluted net income (loss) per common share has been computed by dividing diluted net income (loss) by the weighted average diluted number of shares outstanding during the period. Except where the result would be antidilutive to net income, diluted net income per common share has been computed assuming the conversion of obligations and the elimination of the interest expense related to our 2.50% convertible senior notes due 2017 (2017 Notes), 1.125% convertible senior notes due 2018 (2018 Notes), 1.875% convertible senior notes due 2020 (2020 Notes), the exercise of stock options, the exercise of warrants issued in connection with the convertible bond hedge transactions discussed below, and the vesting of restricted stock units (RSUs), as well as their related income tax effects. |
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In September 2013, in connection with the issuance of the 2018 Notes and 2020 Notes, we entered into convertible bond hedge transactions. The convertible bond hedges are not considered for purposes of calculating the number of diluted shares outstanding, as their effect would be antidilutive. The convertible bond hedges are generally expected, but not guaranteed, to reduce the potential dilution upon conversion of the 2018 Notes and 2020 Notes. See Note H., "Debt," for additional information. |
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The following table sets forth the computation of basic and diluted net income (loss) per common share for the periods presented: |
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2014 | | 2013 | | 2014 | | 2013 |
| (in thousands, except share and per share data) |
Net income (loss), basic | $ | 22,829 | | | $ | (33,895 | ) | | $ | 71,090 | | | $ | (12,565 | ) |
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Effect of dilutive securities: | | | | | | | | | |
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Interest on 2017 Notes, net of tax | 772 | | | — | | | 2,343 | | | — | |
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Debt issuance costs related to 2017 Notes, net of tax | 104 | | | — | | | 315 | | | — | |
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Debt discount amortization related to 2017 Notes, net of tax | 1,100 | | | — | | | 3,265 | | | — | |
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Net income (loss), diluted | $ | 24,805 | | | $ | (33,895 | ) | | $ | 77,013 | | | $ | (12,565 | ) |
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Shares used in calculating basic net income (loss) per common share | 75,834,443 | | | 67,841,665 | | | 75,400,064 | | | 66,122,521 | |
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Effect of dilutive securities: | | | | | | | | | |
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Options to purchase shares of common stock and RSUs | 2,318,634 | | | — | | | 2,658,833 | | | — | |
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2017 Notes convertible into shares of common stock | 7,842,650 | | | — | | | 7,842,763 | | | — | |
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Shares used in calculating diluted net income (loss) per common share | 85,995,727 | | | 67,841,665 | | | 85,901,660 | | | 66,122,521 | |
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Basic net income (loss) per common share | $ | 0.3 | | | $ | (0.50 | ) | | $ | 0.94 | | | $ | (0.19 | ) |
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Diluted net income (loss) per common share | $ | 0.29 | | | $ | (0.50 | ) | | $ | 0.9 | | | $ | (0.19 | ) |
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Potential common shares excluded from the calculation of diluted net income (loss) per common share, as their inclusion would have been antidilutive, were as follows: |
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| Three Months Ended September 30, | | Nine Months Ended September 30, | | | | |
| 2014 | | 2013 | | 2014 | | 2013 | | | | |
Options to purchase shares of common stock and RSUs | 904,954 | | | 8,739,777 | | | 750,827 | | | 8,739,777 | | | | | |
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Warrants | 9,705,442 | | | 9,705,442 | | | 9,705,442 | | | 9,705,442 | | | | | |
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2020 Notes convertible into shares of common stock | 5,459,311 | | | 5,459,311 | | | 5,459,311 | | | 5,459,311 | | | | | |
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2018 Notes convertible into shares of common stock | 4,246,131 | | | 4,246,131 | | | 4,246,131 | | | 4,246,131 | | | | | |
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2017 Notes convertible into shares of common stock | — | | | 7,842,943 | | | — | | | 7,842,943 | | | | | |
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At our annual meeting of shareholders in June 2014, our stockholders approved an amendment to our Restated Certificate of Incorporation to increase the number of authorized shares of our common stock from 150.0 million to 300.0 million. |
Accumulated Other Comprehensive Income | ' |
Accumulated Other Comprehensive Income |
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Accumulated other comprehensive income consists of unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments. Amounts recorded to accumulated other comprehensive income for the three and nine months ended September 30, 2014 and 2013, were not material. Additionally, there were no material reclassifications out of accumulated other comprehensive income for the three and nine months ended September 30, 2014 and 2013. |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In June 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. The standard clarifies that a performance target that affects vesting and could be achieved after the requisite service period be treated as a performance condition. Additionally, compensation cost should be recognized in the period in which it becomes probable that the performance condition will be achieved. This ASU is effective for annual periods and interim periods within those annual periods beginning after December 15, 2015, and early adoption is permitted. We elected to adopt this standard in the third quarter of 2014, and the adoption of this ASU did not have a material impact on our consolidated financial statements. |
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In May 2014, the FASB issued ASU No. 2014-09—Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Accounting Standards Codification 605, Revenue Recognition. This ASU stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. This ASU is effective for annual and interim reporting periods beginning on or after December 15, 2016, and early adoption is not permitted. The ASU permits the use of two transition methods, either retrospectively to each prior reporting period presented or as a cumulative-effect adjustment as of the date of adoption. We have not yet selected a transition method, and are currently evaluating the impact of the adoption of this ASU on our consolidated financial statements. |