BASIS OF PRESENTATION AND ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2013 |
BASIS OF PRESENTATION AND ACCOUNTING POLICIES | ' |
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. (“Cubist” or the “Company”) in accordance with accounting principles generally accepted in the United States of America, or 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 the Company’s 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 for the year ended December 31, 2012, which are contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 27, 2013. The condensed consolidated financial statements, in the opinion of management, reflect all normal and recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations. |
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The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The assets acquired and liabilities assumed in connection with the Company’s acquisition of Trius Therapeutics, Inc., or Trius, on September 11, 2013, were recorded at their fair values as of the date of acquisition. The operating results of Trius have been consolidated with those of Cubist from the date of acquisition. See Note C., “Business Combinations and Acquisitions,” for additional information. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future period or the entire fiscal year. The accompanying condensed consolidated financial statements do not contemplate the impact of the Company’s acquisition of Optimer Pharmaceuticals, Inc., or Optimer, which was completed on October 24, 2013. See Note O., “Subsequent Events,” for additional information. |
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Use of Estimates | ' |
Use of Estimates |
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The preparation of financial statements in conformity with GAAP requires the extensive use of estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. The most significant assumptions are employed in estimates used in determining 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, or IPR&D, and other intangible assets; accrued clinical research costs; contingent consideration; income taxes; accounting for 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. |
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Fair Value Measurements | ' |
Fair Value Measurements |
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The accounting standard for fair value measurements defines fair value, establishes a framework for measuring fair value in accordance with GAAP, and requires detailed disclosures about fair value measurements. Under this standard, fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect certain market assumptions. This standard classifies these inputs into the following hierarchy: |
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Level 1 Inputs—Quoted prices for identical instruments in active markets. |
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Level 2 Inputs—Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. |
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Level 3 Inputs—Instruments with primarily unobservable value drivers. |
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The fair value hierarchy level is determined by asset class based on the lowest level of significant input. In periods of market inactivity, the observability of prices and inputs may be reduced for certain instruments. This condition could cause an instrument to be reclassified between Level 1 and Level 2 or between Level 2 and Level 3. During the three and nine months ended September 30, 2013, there were no transfers between Level 1, Level 2 and Level 3. |
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The carrying amounts of Cubist’s cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these amounts. Short-term and long-term investments primarily consist of available-for-sale securities as of September 30, 2013 and December 31, 2012, and are carried at fair value. |
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Concentration of Risk | ' |
Concentration of Risk |
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Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents, investments and accounts receivable. The Company’s cash and cash equivalents are held with several major financial institutions. The Company’s investments are restricted, in accordance with its investment policy, to a concentration limit per institution. |
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Cubist’s accounts receivable as of September 30, 2013 and December 31, 2012, primarily represent amounts due to the Company from wholesalers, including AmerisourceBergen Drug Corporation, Cardinal Health, Inc. and McKesson Corporation. Cubist performs ongoing credit evaluations of its key wholesalers, distributors and other customers and generally does not require collateral. For the three and nine months ended September 30, 2013 and 2012, Cubist did not have any significant write-offs of accounts receivable, and its days sales outstanding has not significantly changed since December 31, 2012. |
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| | Percentage of Total Accounts | | | | | | | | | |
Receivable Balance as of | | | | | | | | |
| | September 30, | | December 31, | | | | | | | | | |
2013 | 2012 | | | | | | | | |
AmerisourceBergen Drug Corporation | | 20 | % | 22 | % | | | | | | | | |
Cardinal Health, Inc. | | 17 | % | 18 | % | | | | | | | | |
McKesson Corporation | | 20 | % | 20 | % | | | | | | | | |
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| | Percentage of Total | | Percentage of Total | | | | | |
Net Revenues for | Net Revenues for | | | | |
the Three Months Ended | the Nine Months Ended | | | | |
September 30, | September 30, | | | | |
| | 2013 | | 2012 | | 2013 | | 2012 | | | | | |
AmerisourceBergen Drug Corporation | | 18 | % | 20 | % | 19 | % | 20 | % | | | | |
Cardinal Health, Inc. | | 17 | % | 18 | % | 17 | % | 19 | % | | | | |
McKesson Corporation | | 18 | % | 18 | % | 18 | % | 18 | % | | | | |
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IPR&D | ' |
IPR&D |
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IPR&D acquired in a business combination is capitalized on the Company’s condensed consolidated balance sheets at its acquisition-date fair value. 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 IPR&D is amortized over the estimated useful life of the asset. 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 the Company’s product candidates, Cubist 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. 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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The Company’s principal sources of revenue during the reporting period were: (i) sales of CUBICIN® (daptomycin for injection) and ENTEREG® (alvimopan) in the United States, or U.S.; (ii) revenues derived from sales of CUBICIN by Cubist’s international distribution partners; (iii) license fees and milestone payments that are derived from collaboration, license and commercialization agreements with other biopharmaceutical companies; and (iv) service revenues derived from Cubist’s co-promotion agreement with Optimer for the promotion and support of DIFICID® (fidaxomicin) in the U.S., which was terminated on October 24, 2013, as a result of the completion of Cubist’s acquisition of Optimer. See Note O., “Subsequent Events,” for additional information. 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 for returns, chargebacks, Medicaid program rebates, Medicare coverage gap discount program rebates, wholesaler management fees, volume-based rebates and discounts 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, 2013 and 2012, as follows: |
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| | Three Months Ended | | Nine Months Ended | |
September 30, | September 30, |
| | 2013 | | 2012 | | 2013 | | 2012 | |
| | (in thousands) | |
Gross U.S. product revenues | | $ | 277,999 | | $ | 250,881 | | $ | 796,217 | | $ | 716,906 | |
Provisions offsetting U.S. product revenues: | | | | | | | | | |
Contractual adjustments | | (13,249 | ) | (13,535 | ) | (43,281 | ) | (40,516 | ) |
Governmental rebates | | (21,154 | ) | (18,992 | ) | (56,589 | ) | (54,001 | ) |
Total provisions offsetting product revenues | | (34,403 | ) | (32,527 | ) | (99,870 | ) | (94,517 | ) |
U.S. product revenues, net | | $ | 243,596 | | $ | 218,354 | | $ | 696,347 | | $ | 622,389 | |
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Certain product sales qualify for rebates or discounts from standard list pricing due to government-sponsored programs or other contractual agreements. Contractual adjustments in the table above include provisions for returns, volume-based rebates, and pricing and early payment discounts extended to the Company’s external customers, as well as wholesaler distribution fees. Governmental rebates in the table above represent estimated amounts for Medicaid program rebates, Medicare coverage gap discount program rebates and chargebacks related to 340B/Public Health Service and Federal Supply Schedule drug pricing programs. Estimates and assumptions for reserves are analyzed quarterly. The Company reversed approximately $6.0 million and $14.1 million of revenue reserves, 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 during the three and nine months ended September 30, 2013, respectively. |
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Basic and Diluted Net (Loss) Income Per Share | ' |
Basic and Diluted Net (Loss) Income Per Share |
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Basic net (loss) income per common share has been computed by dividing net (loss) income by the weighted average number of shares outstanding during the period. Diluted net (loss) income per share has been computed by dividing diluted net (loss) income by the diluted number of shares outstanding during the period. Except where the result would be antidilutive to income from continuing operations, diluted net income per share has been computed assuming the conversion of convertible obligations and the elimination of the interest expense related to the Company’s 2.25% convertible subordinated notes due June 2013, or 2013 Notes, 2.50% convertible senior notes due 2017, or 2017 Notes, 1.125% convertible senior notes due 2018, or 2018 Notes, 1.875% convertible senior notes due 2020, or 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, or RSUs, as well as their related income tax effects. In 2012, Cubist retired the remainder of its 2013 Notes. |
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In September 2013, in connection with the issuance of the 2018 Notes and 2020 Notes, the Company entered into convertible bond hedge transactions, or convertible bond hedges. 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 and/or offset the cash payments Cubist is required to make upon conversion of the 2018 Notes and 2020 Notes. See Note J., “Debt,” and Note K., “Employee Stock Benefit Plans,” for additional information. |
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The following table sets forth the computation of basic and diluted net (loss) income per common share: |
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| | Three Months Ended | | Nine Months Ended | |
September 30, | September 30, |
| | 2013 | | 2012 | | 2013 | | 2012 | |
| | (in thousands, except share and per share amounts) | |
Net (loss) income, basic | | $ | (33,895 | ) | $ | 40,321 | | $ | (12,565 | ) | $ | 116,238 | |
Effect of dilutive securities: | | | | | | | | | |
Interest on 2017 Notes, net of tax | | — | | 1,853 | | — | | 5,469 | |
Debt issuance costs related to 2017 Notes, net of tax | | — | | 245 | | — | | 723 | |
Debt discount amortization related to 2017 Notes, net of tax | | — | | 2,296 | | — | | 6,659 | |
Interest on 2013 Notes, net of tax | | — | | 128 | | — | | — | |
Debt issuance costs related to 2013 Notes, net of tax | | — | | 17 | | — | | — | |
Debt discount amortization related to 2013 Notes, net of tax | | — | | 316 | | — | | — | |
Net (loss) income, diluted | | $ | (33,895 | ) | $ | 45,176 | | $ | (12,565 | ) | $ | 129,089 | |
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Shares used in calculating basic net (loss) income per common share | | 67,841,665 | | 64,048,673 | | 66,122,521 | | 63,521,491 | |
Effect of dilutive securities: | | | | | | | | | |
Options to purchase shares of common stock and RSUs | | — | | 2,262,445 | | — | | 2,305,428 | |
2017 Notes convertible into shares of common stock | | — | | 15,424,155 | | — | | 15,424,155 | |
2013 Notes convertible into shares of common stock | | — | | 1,121,639 | | — | | — | |
Shares used in calculating diluted net (loss) income per common share | | 67,841,665 | | 82,856,912 | | 66,122,521 | | 81,251,074 | |
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Net (loss) income per share, basic | | $ | (0.50 | ) | $ | 0.63 | | $ | (0.19 | ) | $ | 1.83 | |
Net (loss) income per share, diluted | | $ | (0.50 | ) | $ | 0.55 | | $ | (0.19 | ) | $ | 1.59 | |
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Potential common shares excluded from the calculation of diluted net (loss) income per share, as their inclusion would have been antidilutive, were: |
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| | Three Months Ended | | Nine Months Ended | | | | | |
September 30, | September 30, | | | | |
| | 2013 | | 2012 | | 2013 | | 2012 | | | | | |
Options to purchase shares of common stock and RSUs | | 8,739,777 | | 2,059,361 | | 8,739,777 | | 2,535,235 | | | | | |
Warrants | | 9,705,442 | | — | | 9,705,442 | | — | | | | | |
2020 Notes convertible into shares of common stock | | 5,459,311 | | — | | 5,459,311 | | — | | | | | |
2018 Notes convertible into shares of common stock | | 4,246,131 | | — | | 4,246,131 | | — | | | | | |
2017 Notes convertible into shares of common stock | | 7,842,943 | | — | | 7,842,943 | | — | | | | | |
2013 Notes convertible into shares of common stock | | — | | — | | — | | 2,521,856 | | | | | |
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Accumulated Other Comprehensive Income | ' |
Accumulated Other Comprehensive Income |
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In February 2013, the Financial Accounting Standards Board, or FASB, issued amended accounting guidance for reporting accumulated other comprehensive income. The amendments require a company to provide information about the amounts reclassified out of accumulated other comprehensive income by component. In addition, a company is required to present, either on the face of the statement where net income is presented or in the notes, significant amounts reclassified out of accumulated other comprehensive income by the respective line items of net income. The Company adopted this guidance on January 1, 2013. The Company did not recognize any realized gains or losses from sales of its available-for-sale securities and did not reclassify any amounts out of accumulated other comprehensive income during the three and nine months ended September 30, 2013. |
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Subsequent Events | ' |
Subsequent Events |
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Cubist considers events or transactions that have occurred after the balance sheet date of September 30, 2013, but prior to the filing of the financial statements with the SEC on this Form 10-Q to provide additional evidence relative to certain estimates or to identify matters that require additional recognition or disclosure. On October 24, 2013, Cubist completed the acquisition of Optimer. See Note O., “Subsequent Events,” for additional information. |
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Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In July 2013, the FASB issued an accounting standards update clarifying the presentation of an unrecognized tax benefit when a net operating loss, or NOL, carryforward, a similar tax loss, or a tax credit carryforward exists. The updated guidance requires the netting of unrecognized tax benefits against a deferred tax asset for a loss or other carryforward when settlement of the liability for an unrecognized tax benefit in this manner is available. The update is effective prospectively for reporting periods beginning after December 15, 2013, and early adoption and retrospective adoption are permitted. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. |
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