Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 03, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2019 | |
Document Transition Report | false | |
Entity File Number | 001-35060 | |
Entity Registrant Name | PACIRA BIOSCIENCES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 51-0619477 | |
Entity Address, Address Line One | 5 Sylvan Way, Suite 300 | |
Entity Address, City or Town | Parsippany | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07054 | |
City Area Code | 973 | |
Local Phone Number | 254-3560 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | PCRX | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 41,730,807 | |
Entity Central Index Key | 0001396814 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus (Q1,Q2,Q3,FY) | Q3 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 85,139,000 | $ 132,526,000 |
Short-term investments | 180,505,000 | 250,928,000 |
Accounts receivable, net | 42,573,000 | 38,000,000 |
Inventories, net | 60,238,000 | 48,569,000 |
Prepaid expenses and other current assets | 10,392,000 | 7,946,000 |
Total current assets | 378,847,000 | 477,969,000 |
Long-term investments | 70,577,000 | 25,871,000 |
Fixed assets, net | 104,856,000 | 108,670,000 |
Right-of-use assets, net | 35,756,000 | 0 |
Goodwill | 99,547,000 | 62,040,000 |
Intangible assets, net | 106,354,000 | 0 |
Equity investment and other assets | 11,552,000 | 14,803,000 |
Total assets | 807,489,000 | 689,353,000 |
Current liabilities: | ||
Accounts payable | 16,064,000 | 14,368,000 |
Accrued expenses | 61,002,000 | 45,865,000 |
Lease liabilities | 5,043,000 | 0 |
Convertible senior notes | 0 | 338,000 |
Contingent consideration | 13,591,000 | 0 |
Income taxes payable | 138,000 | 90,000 |
Total current liabilities | 95,838,000 | 60,661,000 |
Convertible senior notes | 302,081,000 | 290,592,000 |
Lease liabilities | 38,882,000 | 0 |
Contingent consideration | 22,206,000 | 0 |
Other liabilities | 2,320,000 | 16,874,000 |
Total liabilities | 461,327,000 | 368,127,000 |
Commitments and contingencies (Note 16) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding at September 30, 2019 and December 31, 2018 | 0 | 0 |
Common stock, par value $0.001; 250,000,000 shares authorized; 41,700,320 shares issued and outstanding at September 30, 2019; 41,222,799 shares issued and outstanding at December 31, 2018 | 42,000 | 41,000 |
Additional paid-in capital | 740,183,000 | 709,691,000 |
Accumulated deficit | (394,510,000) | (388,226,000) |
Accumulated other comprehensive income (loss) | 447,000 | (280,000) |
Total stockholders’ equity | 346,162,000 | 321,226,000 |
Total liabilities and stockholders’ equity | $ 807,489,000 | $ 689,353,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 41,700,320 | 41,222,799 |
Common stock, shares outstanding | 41,700,320 | 41,222,799 |
Treasury stock at cost, shares | 0 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Collaborative Licensing and Development Revenue | $ 0 | $ 0 | $ 0 | $ 3,000,000 |
Revenues: | ||||
Total revenues | 104,685,000 | 83,448,000 | 298,602,000 | 242,163,000 |
Operating expenses: | ||||
Cost of goods sold | 22,304,000 | 19,065,000 | 74,809,000 | 62,866,000 |
Research and development | 20,255,000 | 14,897,000 | 52,466,000 | 41,514,000 |
Selling, general and administrative | 50,128,000 | 44,179,000 | 146,559,000 | 132,619,000 |
Amortization of acquired intangible assets | 1,967,000 | 0 | 3,736,000 | 0 |
Acquisition-related charges and product discontinuation, net | 7,618,000 | 1,259,000 | 12,266,000 | 1,511,000 |
Total operating expenses | 102,272,000 | 79,400,000 | 289,836,000 | 238,510,000 |
Income from operations | 2,413,000 | 4,048,000 | 8,766,000 | 3,653,000 |
Other (expense) income: | ||||
Interest income | 1,736,000 | 1,586,000 | 5,709,000 | 4,493,000 |
Interest expense | (5,940,000) | (5,642,000) | (17,631,000) | (16,195,000) |
Other, net | (4,025,000) | (694,000) | (4,051,000) | (699,000) |
Total other expense, net | (8,229,000) | (4,750,000) | (15,973,000) | (12,401,000) |
Income (loss) before income taxes | (5,816,000) | (702,000) | (7,207,000) | (8,748,000) |
Income tax (expense) benefit | (271,000) | 62,000 | 1,079,000 | (8,000) |
Net loss | $ (6,087,000) | $ (640,000) | $ (6,128,000) | $ (8,756,000) |
Earnings Per Share, Basic and Diluted | $ (0.15) | $ (0.02) | $ (0.15) | $ (0.21) |
Weighted average common shares outstanding: | ||||
Basic (in shares) | 41,645 | 40,995 | 41,423 | 40,833 |
Product [Member] | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 104,350,000 | $ 82,708,000 | $ 297,080,000 | $ 237,713,000 |
Royalty [Member] | ||||
Revenue from Contract with Customer, Including Assessed Tax | $ 335,000 | $ 740,000 | $ 1,522,000 | $ 1,450,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (6,087) | $ (640) | $ (6,128) | $ (8,756) |
Other comprehensive income (loss): | ||||
Net unrealized gain (loss) on investments | (53) | 304 | 727 | 213 |
Total other comprehensive income (loss) | (53) | 304 | 727 | 213 |
Comprehensive loss | $ (6,140) | $ (336) | $ (5,401) | $ (8,543) |
CONSOLIDATED STATEMENT OF STOCK
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Convertible Senior Notes Due 2019 | Convertible Senior Notes Due 2019Additional Paid-In Capital |
Increase (Decrease) in Stockholders' Equity | |||||||
Cumulative effect adjustment of the adoption of Accounting Standards Updates | Accounting Standards Update 2018-07 | $ (20) | $ 20 | |||||
Balances (in shares) at Dec. 31, 2017 | 40,669,000 | ||||||
Balance at beginning of period at Dec. 31, 2017 | $ 279,483 | $ 41 | 669,032 | (389,136) | $ (454) | ||
Increase (Decrease) in Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 207,000 | ||||||
Exercise of stock options | 4,474 | $ 0 | 4,474 | ||||
Vested restricted stock units (in shares) | 150,000 | ||||||
Vested restricted stock units | 0 | $ 0 | |||||
Shares issued under employee stock purchase plan (shares) | 35,000 | ||||||
Shares issued under employee stock purchase plan | 952 | 952 | |||||
Stock-based compensation | 23,539 | 23,539 | |||||
Net unrealized gain (loss) on investments | 213 | 213 | |||||
Net loss | (8,756) | (8,756) | |||||
Balances (in shares) at Sep. 30, 2018 | 41,061,000 | ||||||
Balance at end of period at Sep. 30, 2018 | 301,266 | $ 41 | 697,977 | (396,511) | (241) | ||
Balances (in shares) at Jun. 30, 2018 | 40,955,000 | ||||||
Balance at beginning of period at Jun. 30, 2018 | 290,513 | $ 41 | 686,888 | (395,871) | (545) | ||
Increase (Decrease) in Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 104,000 | ||||||
Exercise of stock options | 2,981 | 2,981 | |||||
Vested restricted stock units (in shares) | 2,000 | ||||||
Vested restricted stock units | 0 | ||||||
Stock-based compensation | 8,108 | 8,108 | |||||
Net unrealized gain (loss) on investments | 304 | 304 | |||||
Net loss | (640) | (640) | |||||
Balances (in shares) at Sep. 30, 2018 | 41,061,000 | ||||||
Balance at end of period at Sep. 30, 2018 | 301,266 | $ 41 | 697,977 | (396,511) | (241) | ||
Balances (in shares) at Dec. 31, 2018 | 41,223,000 | ||||||
Balance at beginning of period at Dec. 31, 2018 | 321,226 | $ 41 | 709,691 | (388,226) | (280) | ||
Increase (Decrease) in Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 251,000 | ||||||
Exercise of stock options | 4,995 | $ 1 | 4,994 | ||||
Vested restricted stock units (in shares) | 190,000 | ||||||
Vested restricted stock units | $ 0 | $ 0 | |||||
Shares issued under employee stock purchase plan (shares) | 35,766 | 36,000 | |||||
Shares issued under employee stock purchase plan | $ 1,270 | 1,270 | |||||
Stock-based compensation | 24,461 | 24,461 | |||||
Retirement of equity component of 2019 convertible senior notes | $ (233) | $ (233) | |||||
Net unrealized gain (loss) on investments | 727 | 727 | |||||
Net loss | (6,128) | (6,128) | |||||
Balances (in shares) at Sep. 30, 2019 | 41,700,000 | ||||||
Balance at end of period at Sep. 30, 2019 | 346,162 | $ 42 | 740,183 | (394,510) | 447 | ||
Balances (in shares) at Jun. 30, 2019 | 41,606,000 | ||||||
Balance at beginning of period at Jun. 30, 2019 | 341,650 | $ 42 | 729,531 | (388,423) | 500 | ||
Increase (Decrease) in Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 92,000 | ||||||
Exercise of stock options | 1,408 | 1,408 | |||||
Vested restricted stock units (in shares) | 2,000 | ||||||
Vested restricted stock units | 0 | $ 0 | |||||
Stock-based compensation | 9,244 | 9,244 | |||||
Net unrealized gain (loss) on investments | (53) | (53) | |||||
Net loss | (6,087) | (6,087) | |||||
Balances (in shares) at Sep. 30, 2019 | 41,700,000 | ||||||
Balance at end of period at Sep. 30, 2019 | 346,162 | $ 42 | $ 740,183 | (394,510) | $ 447 | ||
Increase (Decrease) in Stockholders' Equity | |||||||
Cumulative effect adjustment of the adoption of Accounting Standards Updates | (156) | (156) | |||||
Cumulative effect adjustment of the adoption of Accounting Standards Updates | Accounting Standards Update 2014-09 | $ 1,361 | $ 1,361 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net loss | $ (6,128,000) | $ (8,756,000) |
Adjustments to reconcile net loss to net cash provided by operating activities: | ||
Depreciation of fixed assets and amortization of intangible assets | 14,486,000 | 9,114,000 |
Amortization of unfavorable lease obligation and debt issuance costs | 1,273,000 | 1,186,000 |
Amortization of debt discount | 10,216,000 | 9,512,000 |
Loss on disposal and impairment of fixed assets | 998,000 | 10,000 |
Stock-based compensation | 24,461,000 | 23,539,000 |
Business Combination, Contingent Consideration Arrangements, Change in Amount of Contingent Consideration, Liability | 7,327,000 | 0 |
Loss on equity investment | (3,957,000) | (854,000) |
Changes in operating assets and liabilities (net of MyoScience, Inc. acquisition): | ||
Accounts receivable, net | (3,567,000) | (2,265,000) |
Inventories, net | (9,967,000) | (3,473,000) |
Prepaid expenses and other assets | (2,451,000) | (1,412,000) |
Accounts payable | 829,000 | (1,400,000) |
Accrued expenses and income taxes payable | 4,004,000 | (71,000) |
Other liabilities | (822,000) | 812,000 |
Net cash provided by operating activities | 44,616,000 | 27,650,000 |
Investing activities: | ||
Acquisition of MyoScience, Inc. (net of cash acquired) | (118,683,000) | 0 |
Purchases of fixed assets | (5,662,000) | (12,271,000) |
Purchases of investments | (220,091,000) | (182,750,000) |
Sales of investments | 248,365,000 | 345,602,000 |
Payment of contingent consideration | 0 | (6,842,000) |
Equity Investment | (1,622,000) | 0 |
Net cash (used in) provided by investing activities | (97,693,000) | 143,739,000 |
Financing activities: | ||
Proceeds from exercises of stock options | 4,991,000 | 4,474,000 |
Proceeds from shares issued under employee stock purchase plan | 1,270,000 | 952,000 |
Repayment of 2019 convertible senior notes | (338,000) | 0 |
Conversion premium on convertible senior notes | (233,000) | 0 |
Net cash provided by financing activities | 5,690,000 | 5,426,000 |
Net (decrease) increase in cash and cash equivalents | (47,387,000) | 176,815,000 |
Cash and cash equivalents, beginning of period | 132,526,000 | 54,126,000 |
Cash and cash equivalents, end of period | 85,139,000 | 230,941,000 |
Supplemental cash flow information: | ||
Cash paid for interest | 4,102,000 | 4,108,000 |
Income Taxes Paid, Net | 702,000 | 146,000 |
Non-cash investing and financing activities: | ||
Net increase in contingent consideration liabilities | 28,470,000 | 0 |
Net increase (decrease) in accrued fixed assets | $ 1,663,000 | $ (130,000) |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | DESCRIPTION OF BUSINESS Pacira BioSciences, Inc. and its subsidiaries (collectively, the “Company” or “Pacira”) is a leading provider of non-opioid pain management options to advance and improve outcomes for health care practitioners and their patients. The Company’s long-acting, local analgesic, EXPAREL ® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam ® , a unique and proprietary delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, the Company added iovera° ® to its commercial offering with its acquisition of MyoScience, Inc., or MyoScience. The iovera° system is a handheld cryoanalgesia device used to deliver a precise, controlled application of cold temperature to only targeted nerves. The Company changed its name from Pacira Pharmaceuticals, Inc. to Pacira BioSciences, Inc. upon completing the acquisition of MyoScience in order to better reflect a broadening portfolio of innovative non-opioid pain management and regenerative health solutions. See Note 4, MyoScience Acquisition , for more information. Pacira is subject to risks common to companies in similar industries and stages, including, but not limited to, competition from larger companies, reliance on revenue from two products, reliance on a limited number of manufacturing sites, new technological innovations, dependence on key personnel, reliance on third-party service providers and sole source suppliers, protection of proprietary technology, compliance with government regulations and risks related to cybersecurity. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principles of Consolidation These interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP, and in accordance with the rules and regulations of the United States Securities and Exchange Commission, or SEC, for interim reporting. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in complete annual financial statements have been condensed or omitted. Therefore, these interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . The condensed consolidated financial statements at September 30, 2019 , and for the three and nine month periods ended September 30, 2019 and 2018 , are unaudited, but include all adjustments (consisting of only normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the financial information set forth herein in accordance with GAAP. The condensed consolidated balance sheet at December 31, 2018 is derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . The condensed consolidated financial statements as presented reflect certain reclassifications from previously issued financial statements to conform to the current year presentation. The accounts of wholly-owned subsidiaries are included in the condensed consolidated financial statements. Intercompany accounts and transactions have been eliminated in consolidation. The results of operations for these interim periods are not necessarily indicative of results that may be expected for any other interim periods or for the full year. Concentration of Major Customers The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers (including AmerisourceBergen Health Corporation, Cardinal Health, Inc. and McKesson Drug Company), but shipments of the product are sent directly to individual accounts, such as hospitals, ambulatory surgery centers and individual doctors. The Company also sells EXPAREL directly to ambulatory surgery centers and physicians. The Company sells its bupivacaine liposome injectable suspension for use in animals to a third party licensee and sells iovera° directly to end users. The table below includes the percentage of revenue comprised by the Company’s three largest wholesalers in each period presented: Three Months Ended Nine Months Ended 2019 2018 2019 2018 Largest wholesaler 34% 34% 34% 34% Second largest wholesaler 29% 30% 29% 30% Third largest wholesaler 27% 26% 26% 26% Total 90% 90% 89% 90% Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-02, Leases (Topic 842) , and subsequently issued clarifications and corrections to the update by issuing ASU 2018-10 in July 2018. This update required lessees to recognize lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous authoritative guidance. For income statement purposes, the new standard retained a dual model similar to Accounting Standards Codification, or ASC, 840, requiring leases to be classified as either operating or financing. Operating leases continue to result in straight-line expense while financing leases result in a front-loaded expense pattern (similar to previous accounting guidance by lessees for operating and capital leases, respectively, under ASC 840). The Company adopted ASU 2016-02 on January 1, 2019 using the effective date method. There were practical expedients available to the Company at transition that it elected to apply upon adoption. The Company did not re-assess (i) whether its contracts contained a lease under the new definition of a lease and (ii) the classification of those leases. There were no initial direct costs previously capitalized on the consolidated balance sheet. In addition, the Company applied hindsight in the determination of the lease terms, in the assessment of the likelihood that a lease renewal, termination or purchase option will be exercised, and in the assessment of any potential impairments that existed on the right-of-use, or ROU, assets recognized at adoption. The Company also elected not to recognize a ROU asset and lease liability for those leases with a remaining lease term of 12 months or less. At adoption on January 1, 2019, the lease liability was equal to the present value of future lease payments and a ROU asset was recorded based on the lease liability, adjusted for items such as prepaid and accrued lease payments. The Company recorded $36.5 million of lease liabilities and $27.6 million of ROU assets as of January 1, 2019, the difference representing previously recorded lease-related assets and liabilities. There was a cumulative-effect adjustment to retained earnings of $0.2 million upon adoption. Refer to Note 7, Leases , for further information on the Company’s existing leases. The lease liability recognized upon adoption was based upon the present value of the sum of the remaining minimum lease payments (as previously identified under ASC 840), determined using the discount rate as of the date of adoption. The discount rate was based on the Company’s incremental borrowing rate on a collateralized basis over a similar remaining term and in a similar economic environment. Recent Accounting Pronouncements Not Adopted as of September 30, 2019 In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. Entities will now use forward-looking information to better form their credit loss estimates. This update also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an entity’s portfolio. This standard will become effective for the Company beginning January 1, 2020, with early adoption permitted. The Company does not expect there to be a significant impact from the adoption of ASU 2016-13 on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework. The purpose of the update is to improve the effectiveness of the fair value measurement disclosures that allows for clear communication of information that is most important to the users of financial statements. There were certain required disclosures that have been removed or modified. In addition, the update added the following disclosures: (i) changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and (ii) the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The standard will become effective for the Company beginning January 1, 2020. The Company does not expect there to be a significant impact from the adoption of ASU 2018-13 on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The update provides guidance to determine which implementation costs to capitalize as they relate to the service contract and which costs to expense. In addition, the update further defines the term of the hosting arrangement to include the non-cancelable period of the arrangement plus periods covered by (i) an option to extend the arrangement if the customer is reasonably certain to exercise that option; (ii) an option to terminate the arrangement if the customer is reasonably certain not to exercise the termination option and (iii) an option to extend (or not to terminate) the arrangement in which exercise of the option is in the control of the vendor. Any expense related to the capitalized implementation costs should be recorded in the same financial statement line item in the consolidated statements of operations as the fees associated with the hosting element of the arrangement, and the payments for capitalized implementation costs should be classified in the same manner as payments made for fees associated with the hosting element in the consolidated statements of cash flows. This standard will become effective for the Company beginning January 1, 2020. The amendments may be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company expects to apply ASU 2018-15 on a prospective basis. The Company will apply this standard to future implementation costs incurred. The impact of ASU 2018-15 will be dependent upon future projects entered into by the Company subsequent to the date of adoption. In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which provides amendments to the recognition and measurement of certain financial assets and financial liabilities. One of those amendments requires that equity securities without readily determinable fair values accounted for under the measurement alternative be re-measured when an orderly transaction is identified for an identical or similar investment of the same issuer. This standard will become effective for the Company beginning January 1, 2020. The Company does not expect there to be a significant impact from the adoption of ASU 2019-04 on its consolidated financial statements. Other pronouncements issued by the FASB or other authoritative accounting standards groups with future effective dates are either not applicable or not significant to the consolidated financial statements of the Company. Significant Accounting Policies Leases Effective January 1, 2019, the Company recognizes ROU assets and lease liabilities at the commencement of its lease agreements. The leases are evaluated at commencement to determine whether they should be classified as operating or financing leases. Lease costs associated with operating leases are recognized on a straight-line basis, while lease costs for financing leases are recognized over the lease term using the effective interest method. To date, the Company does not have any financing leases. The amount of ROU assets and lease liabilities to be recognized is impacted by the type of lease payments, the lease term and the incremental borrowing rate. Variable lease payments are not included at commencement and are recognized in the period in which they are incurred. The lease term is based on the contractual term and is adjusted for any renewal options or termination rights that are reasonably certain to be exercised. The incremental borrowing rate is based on the rate the Company estimates it would pay on a collateralized basis over a similar term in a similar economic environment. Acquisitions In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values with some exceptions. Assets acquired and liabilities assumed in a business combination that arise from contingencies are generally recognized at fair value. If fair value cannot be determined, the asset or liability is recognized if probable and reasonably estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair value measures that do not reflect the Company’s intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company’s condensed consolidated financial statements after the date of the acquisition. If the Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an acquisition of assets rather than as a business combination and, therefore, no goodwill would be recorded. Contingent Consideration Subsequent to an acquisition, the Company measures contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as acquisition-related charges. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales, costs of goods sold and regulatory approvals. In the absence of new information, changes in fair value reflect the passage of time towards achievement of the milestones, and are accrued based on an accretion schedule. Intangible Assets Intangible assets with definite useful lives are amortized on a straight-line basis over their estimated useful lives and are reviewed for impairment if certain events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Intangible assets are recorded at cost, net of accumulated amortization. The Company evaluates the recoverability of intangible assets periodically and takes into account events and circumstances which may indicate that an impairment exists. Segment Reporting The Company is managed and operated as a single business focused on the discovery, development, manufacture, marketing, distribution and sale of non-opioid pain management options. The Company is managed by a single management team, and, consistent with its organizational structure, the Chief Executive Officer and Chairman manages and allocates resources at a consolidated level. Accordingly, the Company views its business as one reportable operating segment to evaluate performance, allocate resources, set operational targets and forecast its future period financial results. |
REVENUE
REVENUE | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE | REVENUE Revenue from Contracts with Customers The Company’s sources of revenue include (i) sales of EXPAREL/bupivacaine liposome injectable suspension in the United States, or U.S.; (ii) sales of iovera° in the U.S.; (iii) royalties based on sales of its bupivacaine liposome injectable suspension product for use in animals and (iv) license fees and milestone payments. The majority of the Company’s revenue is derived from net product sales of EXPAREL. As such, the following disclosure only relates to revenue associated with net EXPAREL product sales. Net Product Sales The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers based on orders of the product placed by end-users which include hospitals, ambulatory surgery centers and doctors. EXPAREL is delivered directly to the end-user without the wholesaler ever taking physical possession of the product. Product revenue is recognized when control of the promised goods are transferred to the customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for transferring those goods. EXPAREL revenue is recorded at the time the product is delivered to the end-user. Revenues from sales of products are recorded net of returns allowances, prompt payment discounts, wholesaler service fees, volume rebates and chargebacks. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale, using the most likely amount method for the gross to net adjustments, except for returns, which is based on the expected value method. The Company includes these estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved. The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis. Accounts Receivable The majority of accounts receivable arise from product sales and represent amounts due from wholesalers, hospitals, ambulatory surgery centers and doctors. Payment terms generally range from zero to 37 days from the date of the transaction, and accordingly, there is no significant financing component. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. At contract inception, the Company assesses the goods promised in its contracts with customers and identifies a performance obligation for each promise to transfer to the customer a good that is distinct. When identifying individual performance obligations, the Company considers all goods promised in the contract regardless of whether explicitly stated in the customer contract or implied by customary business practices. The Company’s contracts with customers require it to transfer an individual distinct product, which represents a single performance obligation. The Company’s performance obligation with respect to its product sales is satisfied at a point in time, which transfers control upon delivery of EXPAREL to its customers. The Company considers control to have transferred upon delivery because the customer has legal title to the asset, physical possession of the asset has been transferred, the customer has significant risks and rewards of ownership of the asset and the Company has a present right to payment at that time. Disaggregated Revenue The following table represents disaggregated net product sales in the periods presented as follows (in thousands): Three Months Ended Nine Months Ended Net Product Sales 2019 2018 2019 2018 EXPAREL / bupivacaine liposome injectable suspension $ 101,711 $ 82,708 $ 292,406 $ 237,713 iovera° 2,639 — 4,674 — Total net product sales $ 104,350 $ 82,708 $ 297,080 $ 237,713 |
MYOSCIENCE ACQUISITION
MYOSCIENCE ACQUISITION | 9 Months Ended |
Sep. 30, 2019 | |
Business Combinations [Abstract] | |
MYOSCIENCE ACQUISITION | MYOSCIENCE ACQUISITION On April 9, 2019, the Company acquired MyoScience (the “MyoScience Acquisition”), a privately-held medical device company, pursuant to the terms of an Agreement and Plan of Merger (the “Merger Agreement”), under which MyoScience became a wholly-owned subsidiary of the Company and was renamed Pacira CryoTech, Inc., or CryoTech. The MyoScience Acquisition added iovera° to the Company’s commercial offering. The iovera° system is a novel, United States Food and Drug Administration, or FDA, approved, non-opioid treatment that immediately alleviates pain for up to 90 days by applying intense cold to only targeted nerves in a process called cryoanalgesia. The consideration included an initial cash payment of $120.0 million , reduced by $1.0 million for post-closing purchase price adjustments and indemnification obligations incurred to date, and the fair value of contingent consideration in the amount of $28.5 million . The contingent consideration consists of contingent milestone payments up to an aggregate of $100.0 million upon the achievement of certain regulatory and commercial milestones, of which up to $25.0 million may be payable in shares of the Company’s common stock if achieved in 2020. Per the terms of the Merger Agreement, the Company’s obligation to make milestone payments is limited to those milestones achieved between January 1, 2019 and December 31, 2023, and are to be paid within 60 days of the end of the fiscal quarter of achievement. In the third quarter of 2019, the Company met a regulatory milestone which was previously accrued and will result in a $7.0 million payment to be made in the fourth quarter of 2019. The Company also expects to meet another regulatory milestone which was previously accrued that would result in a $5.0 million payment to be made in 2020. For more information regarding contingent milestone payments subsequent to September 30, 2019, refer to Note 17, Subsequent Events . The Company has accounted for the MyoScience Acquisition using the acquisition method of accounting and, accordingly, has included the assets acquired, liabilities assumed and results of operations in the condensed consolidated financial statements from April 10, 2019 onward, the day following the acquisition date. The excess of the purchase price over the fair value of identifiable net assets acquired represents goodwill. This goodwill is primarily attributable to the value of combining iovera° and EXPAREL as a safe and effective non-opioid multimodal regimen for pain management, as well as the synergies of merging operations. The primary assets and liabilities of the business acquired include developed technology and customer relationship intangible assets, equipment, inventory, receivables, payables and accrued expenses. Inventory has been recorded at its estimated selling price less costs of distribution and a reasonable profit, and the intangible assets acquired (including developed technology and customer relationships) have been recorded at fair value as determined by the Company’s management with the assistance of a third-party valuation specialist. The acquired goodwill and intangible assets are currently not deductible for tax purposes. However, the Company is considering certain tax elections that would allow for the future deduction of acquired goodwill and intangible assets. See Note 8, Goodwill and Intangible Assets , for more information. The total consideration for the MyoScience Acquisition was $147.5 million , which consisted of the following (in thousands): Purchase Price Amount Cash paid, adjusted for working capital items $ 119,038 Fair value of contingent consideration 28,470 Total $ 147,508 The preliminary purchase price allocation is based on estimates, assumptions, valuations and other studies which have not yet been finalized. Prior to the finalization of the purchase price allocation, if information becomes available that would indicate it is probable that unknown events had occurred and the amounts can be reasonably estimated, such items will be included in the final purchase price allocation and may change the carrying value of goodwill. The Company is finalizing its valuation of the intangible assets and tax analyses, and anticipates finalizing the purchase price allocation as the information necessary to complete the analysis is obtained, but no later than one year after the acquisition date. The following tables set forth the preliminary allocation of the MyoScience Acquisition purchase price to the estimated fair value of the net assets acquired at the acquisition date (in thousands): Amounts Recognized at the Acquisition Date (Unaudited) ASSETS ACQUIRED Current assets $ 5,275 Non-current assets (other than intangible assets) 1,044 Intangible assets (excluding goodwill) 110,090 Total assets acquired (excluding goodwill) $ 116,409 LIABILITIES ASSUMED Current liabilities $ 4,436 Deferred tax liabilities, net 1,828 Other non-current liabilities 144 Total liabilities assumed 6,408 Total identifiable net assets acquired 110,001 Goodwill 37,507 Total consideration transferred $ 147,508 CryoTech results from the acquisition date of April 10, 2019 through September 30, 2019, which are included in the condensed consolidated statements of operations, are as follows (in thousands): Classification in Condensed Consolidated Statements of Operations Acquisition Date Through September 30, 2019 Total revenues $ 4,674 Net loss $ (5,555 ) Unaudited Pro Forma Summary of Operations The following table shows the unaudited pro forma summary of operations for the three months ended September 30, 2018 and the nine months ended September 30, 2019 and 2018, as if the MyoScience Acquisition had occurred on January 1, 2018. This pro forma information does not purport to represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2018, and is not indicative of what such results would be expected for any future period (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2018 2019 2018 Total revenues $ 84,916 $ 301,051 $ 245,721 Net loss $ (6,944 ) $ (10,633 ) $ (27,663 ) Pro forma basic and diluted net loss per share $ (0.17 ) $ (0.26 ) $ (0.68 ) The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of the Company and MyoScience. The summary pro forma financial information primarily reflects the following pro forma adjustments: • Removal of the acquisition-related transaction fees and costs, including certain stock-based compensation and other compensation expenses related to the acquisition, from the nine months ended September 30, 2019; • Removal of the income tax benefit resulting from the Company decreasing its existing valuation allowance on deferred tax assets from the nine months ended September 30, 2019; • Removal of MyoScience’s loss on extinguishment of debt and warrant expense in the nine months ended September 30, 2019; • Removal of MyoScience’s interest expense; • Adjustments to the Company’s interest income for the cash used to acquire MyoScience; and • The addition of amortization expense on the acquired developed technology and customer relationship intangible assets. |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | INVENTORIES The components of inventories, net are as follows (in thousands): September 30, December 31, 2019 2018 Raw materials $ 18,798 $ 19,193 Work-in-process 17,472 9,711 Finished goods 23,968 19,665 Total $ 60,238 $ 48,569 The Company is required to perform stability testing on select lots of EXPAREL. In October 2019, a single validation lot of EXPAREL manufactured at the Company’s contract manufacturing site located in the United Kingdom did not meet its required stability specification. The Company has temporarily halted production on the line while it investigates the root cause of the failure. Inventory from this line totals approximately $10.5 million . Depending on the outcome of the investigation and discussions with the FDA, it may be determined that some or all of this inventory may be unsellable. At this stage, no determination of an amount is possible. |
FIXED ASSETS
FIXED ASSETS | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS | FIXED ASSETS Fixed assets, net, summarized by major category, consist of the following (in thousands): September 30, December 31, 2019 2018 Machinery and equipment $ 68,342 $ 67,431 Leasehold improvements 60,355 57,955 Computer equipment and software 8,381 8,131 Office furniture and equipment 1,625 1,548 Construction in progress 38,421 35,163 Total 177,124 170,228 Less: accumulated depreciation (72,268 ) (61,558 ) Fixed assets, net $ 104,856 $ 108,670 For the three months ended September 30, 2019 and 2018, depreciation expense was $3.6 million and $3.5 million, respectively, and for the three months ended both September 30, 2019 and 2018, there was less than $0.1 million of capitalized interest on the construction of manufacturing sites. For the nine months ended September 30, 2019 and 2018, depreciation expense was $10.7 million and $9.1 million , respectively. For the nine months ended September 30, 2019 there was less than $0.1 million of capitalized interest on the construction of manufacturing sites, and for the nine months ended September 30, 2018, capitalized interest was $0.7 million . At September 30, 2019 and December 31, 2018 , total fixed assets, net, includes leasehold improvements and manufacturing process equipment located in Europe in the amount of $65.1 million and $64.6 million , respectively. During the nine months ended September 30, 2019 , the Company recorded increases to its asset retirement obligations, or AROs, of $0.3 million due to a revision in estimated future cash flows related to the AROs (including those resulting from the MyoScience Acquisition). Accretion expense was $0.1 million and $0.2 million in the three and nine months ended September 30, 2019 , respectively. |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
LEASES | LEASES The Company leases its EXPAREL manufacturing, research and development, warehouse and former DepoCyt(e) manufacturing facilities in San Diego, California, its iovera° manufacturing, research and development and warehouse facility in Fremont, California and its corporate headquarters in Parsippany, New Jersey. These leases have remaining terms between one year and eleven years , some of which provide renewal options at the then-current market value, along with one that contains the right to terminate the lease after four years . The Company also has a lease with Thermo Fisher Scientific Pharma Services (“Thermo Fisher”) (formerly Patheon UK Limited), for the use of their facility in Swindon, England, which is embedded in agreements the Company has with Thermo Fisher. A portion of the associated monthly base fees has been allocated to the lease component based on a relative fair value basis. The Company’s facility in Fremont, California, is dedicated to the iovera° product line and consists of approximately 20,000 square feet of mixed use manufacturing, research and development and office space. For a description of the Company’s other material properties, refer to its Annual Report on Form 10-K for the year ended December 31, 2018 . The operating lease costs for the facilities include lease and non-lease components, such as common area maintenance and other common operating expenses, along with executory costs such as insurance and real estate taxes. Total operating lease costs are as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, Operating Lease Costs 2019 2018 2019 2018 Fixed lease costs $ 1,585 $ 2,659 4,544 5,750 Variable lease costs 403 495 1,233 1,305 Total $ 1,988 $ 3,154 $ 5,777 $ 7,055 Supplemental cash flow information related to operating leases is as follows (in thousands): Nine Months Ended September 30, 2019 Cash paid for operating lease liabilities, net of lease incentive $ 5,247 Right-of-use assets recorded in exchange for lease obligations $ 38,419 The Company has elected to net the amortization of the ROU asset and the reduction of the lease liability principal in accrued expenses in the condensed consolidated statement of cash flows. The Company has measured its operating lease liabilities at an estimated discount rate in which it could borrow on a collateralized basis over the remaining term for each operating lease. The weighted average remaining lease term and the weighted average discount rate are summarized as follows: September 30, 2019 Weighted average remaining lease term 9.66 years Weighted average discount rate 7.62% Maturities of the Company’s operating lease liabilities are as follows (in thousands): Year Aggregate Minimum Payments Due 2019 (remaining three months) $ 2,039 2020 7,662 2021 5,359 2022 5,486 2023 5,616 2024 through 2030 37,208 Total lease payments 63,370 Less: imputed interest (19,445 ) Total operating lease liabilities $ 43,925 The Company has entered into three lease agreements (not included in the table above) for which there are future obligations but the leases have not yet commenced as of September 30, 2019 (in thousands): Year Aggregate Minimum Payments Due 2019 (remaining three months) $ 27 2020 2,607 2021 4,878 2022 4,937 2023 5,081 2024 through 2030 35,848 Total future lease payments $ 53,378 As of December 31, 2018, aggregate annual minimum payments due under the Company’s lease obligations were as follows (in thousands): Year Aggregate Minimum Payments Due 2019 $ 8,140 2020 7,621 2021 5,295 2022 5,417 2023 5,543 2024 through 2030 14,329 Total $ 46,345 |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | GOODWILL AND INTANGIBLE ASSETS Goodwill Skyepharma Acquisition In March 2007, the Company acquired from SkyePharma Holding, Inc. (now a subsidiary of Vectura Group plc), or Skyepharma, its California operating subsidiary named Pacira Pharmaceuticals, Inc. (the “Skyepharma Acquisition”). The Company’s goodwill arose in April 2012 from a contingent milestone payment to Skyepharma in connection with the Skyepharma Acquisition. The Skyepharma Acquisition was accounted for under Statement of Financial Accounting Standards 141, Accounting for Business Combinations , which was the effective GAAP standard at the Skyepharma Acquisition date. In connection with the Skyepharma Acquisition, the Company agreed to milestone payments for DepoBupivacaine products, including EXPAREL, as follows: (i) $10.0 million upon the first commercial sale in the United States (met April 2012); (ii) $4.0 million upon the first commercial sale in a major E.U. country (United Kingdom, France, Germany, Italy and Spain); (iii) $8.0 million when annual net sales collected reach $100.0 million (met September 2014); (iv) $8.0 million when annual net sales collected reach $250.0 million (met June 2016); and (v) $32.0 million when annual net sales collected reach $500.0 million . For purposes of meeting future potential milestone payments, annual net sales are measured on a rolling quarterly basis. As part of the Skyepharma Acquisition, the Company agreed to pay certain earn-out payments based on a percentage of net sales of DepoBupivacaine products collected, including EXPAREL, for the term during which such sales were covered by a valid claim in certain patent rights related to EXPAREL and other biologics products. The last patents for which a valid claim existed expired on September 18, 2018 and thus, the only remaining obligations to Skyepharma are the two unmet milestone payments totaling $36.0 million . Any remaining milestone payments will be treated as additional costs of the Skyepharma Acquisition and, therefore, recorded as goodwill if and when each contingency is resolved. There was no change in the carrying value of goodwill related to the Skyepharma Acquisition during the three and nine months ended September 30, 2019 . MyoScience Acquisition In connection with the MyoScience Acquisition, the Company recorded goodwill totaling $37.5 million . The acquired goodwill is currently not deductible for tax purposes. However, the Company is considering certain tax elections that would allow for the future deduction of this acquired goodwill. See Note 4, MyoScience Acquisition , for more information. The change in the carrying value of the Company’s goodwill is summarized as follows (in thousands): Carrying Value of Goodwill Balance at December 31, 2018 $ 62,040 Goodwill arising from the MyoScience Acquisition 37,507 Balance at September 30, 2019 $ 99,547 Intangible Assets MyoScience Acquisition Intangible assets, net, consist of the developed technology and customer relationships that were acquired in the MyoScience Acquisition and are summarized as follows (in thousands): September 30, 2019 Gross Carrying Value Accumulated Intangible Estimated Developed technology $ 110,000 $ (3,732 ) $ 106,268 14 Years Customer relationships 90 (4 ) 86 10 Years Total intangible assets $ 110,090 $ (3,736 ) $ 106,354 There were no intangible assets, net, at December 31, 2018. Amortization expense on intangible assets for the three and nine months ended September 30, 2019 was $2.0 million and $3.7 million , respectively. There was no amortization expense on intangible assets for the three and nine months ended September 30, 2018 . For the remaining three months of 2019, amortization expense on intangible assets will be $2.0 million . Assuming no changes in the gross carrying amount of these intangible assets, the future amortization expense on intangible assets will be $7.9 million annually through 2032 and $2.2 million in 2033. These acquired intangible assets are currently not deductible for tax purposes. However, the Company is considering certain tax elections that would allow for the future deduction of these acquired intangible assets. |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Senior Notes Due 2022 On March 13, 2017, the Company completed a private placement of $345.0 million in aggregate principal amount of 2.375% convertible senior notes due 2022, or 2022 Notes, and entered into an indenture, or 2022 Indenture, with respect to the 2022 Notes. The 2022 Notes accrue interest at a fixed rate of 2.375% per year, payable semiannually in arrears on April 1 st and October 1 st of each year. The 2022 Notes mature on April 1, 2022. The total debt composition of the 2022 Notes is as follows (in thousands): September 30, December 31, 2019 2018 2.375% convertible senior notes due 2022 $ 345,000 $ 345,000 Deferred financing costs (4,577 ) (5,850 ) Discount on debt (38,342 ) (48,558 ) Total debt, net of debt discount and deferred financing costs $ 302,081 $ 290,592 Holders may convert their 2022 Notes prior to October 1, 2021 only if certain circumstances are met, including if during the previous calendar quarter, the last reported sales price of the Company’s common stock was greater than 130% of the conversion price then applicable for at least 20 out of the last 30 consecutive trading days of the quarter. During the quarter ended September 30, 2019 , this condition for conversion was not met. On or after October 1, 2021, until the close of business on the second scheduled trading day immediately preceding April 1, 2022, holders may convert their 2022 Notes at any time. Upon conversion, holders will receive the principal amount of their 2022 Notes and any excess conversion value, calculated based on the per share volume-weighted average price for each of the 40 consecutive trading days during the observation period (as more fully described in the 2022 Indenture). For both the principal and excess conversion value, holders may receive cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s option. The initial conversion rate for the 2022 Notes is 14.9491 shares of common stock per $1,000 principal amount, which is equivalent to an initial conversion price of $66.89 per share of the Company’s common stock. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. The initial conversion price of the 2022 Notes represents a premium of approximately 37.5% to the closing sale price of $48.65 per share of the Company’s common stock on the Nasdaq Global Select Market on March 7, 2017, the date that the Company priced the private offering of the 2022 Notes. As of September 30, 2019 , the 2022 Notes had a market price of $987 per $1,000 principal amount. In the event of conversion, holders would forgo all future interest payments, any unpaid accrued interest and the possibility of stock price appreciation. Upon the receipt of conversion requests, the settlement of the 2022 Notes will be paid pursuant to the terms of the 2022 Indenture. In the event that all of the 2022 Notes are converted, the Company would be required to repay the $345.0 million in principal value and any conversion premium in any combination of cash and shares of its common stock (at the Company’s option). Prior to April 1, 2020, the Company may not redeem the 2022 Notes. On or after April 1, 2020, the Company may redeem for cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s option, all or part of the 2022 Notes if the last reported sale price (as defined in the 2022 Indenture) of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading-day period ending within five trading days prior to the date on which the Company provides notice of redemption. The redemption price will equal the sum of (i) 100% of the principal amount of the 2022 Notes being redeemed, plus (ii) accrued and unpaid interest, including additional interest, if any, to, but excluding, the redemption date. In addition, calling the 2022 Notes for redemption will constitute a “make whole fundamental change” (as defined in the 2022 Indenture) and will, in certain circumstances, increase the conversion rate applicable to the conversion of such notes if it is converted in connection with the redemption. No sinking fund is provided for the 2022 Notes. While the 2022 Notes are currently classified on the Company’s consolidated balance sheet at September 30, 2019 as long-term debt, the future convertibility and resulting balance sheet classification of this liability will be monitored at each quarterly reporting date and will be analyzed dependent upon market prices of the Company’s common stock during the prescribed measurement periods. In the event that the holders of the 2022 Notes have the right to convert the 2022 Notes at any time during the prescribed measurement period, the 2022 Notes would then be considered a current obligation and classified as such. Convertible Senior Notes Due 2019 On February 1, 2019, the Company’s 3.25% convertible senior notes due 2019, or 2019 Notes, matured, and the Company paid the remaining $0.3 million of principal in full, plus a $0.2 million conversion premium in cash. The 2019 Notes accrued interest at a fixed rate of 3.25% per year and were payable semiannually in arrears on February 1 st and August 1 st of each year. Interest Expense The following table sets forth the total interest expense recognized in the periods presented (dollar amounts in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Contractual interest expense $ 2,048 $ 2,051 $ 6,146 $ 6,153 Amortization of debt issuance costs 429 411 1,273 1,219 Amortization of debt discount 3,467 3,228 10,216 9,512 Capitalized interest (Note 6) (4 ) (48 ) (4 ) (689 ) Total $ 5,940 $ 5,642 $ 17,631 $ 16,195 Effective interest rate on convertible senior notes 7.81 % 7.81 % 7.81 % 7.81 % |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in the principal or most advantageous market in an orderly transaction. To increase consistency and comparability in fair value measurements, the FASB established a three-level hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of fair value measurements are: • Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. • Level 2—Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. • Level 3—Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. The carrying value of financial instruments including cash and cash equivalents, accounts receivable and accounts payable approximate their respective fair values due to the short-term nature of these items. The fair value of the Company’s convertible senior notes at September 30, 2019 are calculated utilizing market quotations from an over-the-counter trading market for these notes (Level 2). The fair value of the Company’s acquisition-related contingent consideration is reported at fair value on a recurring basis (Level 3). The carrying amount and fair values of the Company’s convertible senior notes and acquisition-related contingent consideration are as follows (in thousands): Financial Liabilities Carrying Value Fair Value Measurements Using September 30, 2019 Level 1 Level 2 Level 3 2.375% convertible senior notes due 2022 (1)(2) $ 302,081 $ — $ 340,472 $ — Acquisition-related contingent consideration (3) $ 35,797 $ — $ — $ 35,797 (1) The closing price of the Company’s common stock was $38.07 per share at September 30, 2019 compared to a conversion price of $66.89 per share. Currently, the conversion price is above the stock price. The maximum conversion premium that can be due on the 2022 Notes is approximately 5.2 million shares of the Company’s common stock, which assumes no increases in the conversion rate for certain corporate events. (2) Reported at historical cost. (3) Reported at fair value on a recurring basis. Financial Liabilities Measured at Fair Value on a Recurring Basis The Company has recognized contingent consideration in the amount of $35.8 million as of September 30, 2019 . The contingent consideration was recognized as part of the MyoScience Acquisition in April 2019. Refer to Note 4, MyoScience Acquisition , for more information. The Company’s contingent consideration obligations are recorded at their estimated fair values and are revalued each reporting period until the related contingencies are resolved. For the three and nine months ended September 30, 2019, the Company recognized $7.3 million of fair value adjustments related to contingent consideration, which have been included in acquisition-related charges in the condensed consolidated statements of operations. The Company has measured the fair value of its contingent consideration using a probability-weighted discounted cash flow approach that is based on unobservable inputs and a Monte Carlo simulation. These inputs include, as applicable, estimated probabilities and the timing of achieving specified commercial and regulatory milestones; estimated forecasts of revenue and costs and the discount rate used to calculate the present value of estimated future payments. Significant changes may increase or decrease the probabilities of achieving the related commercial and regulatory events, shorten or lengthen the time required to achieve such events, or increase or decrease estimated forecasts. The following table includes the key assumptions used in the valuation of the Company’s contingent consideration: Assumption Ranges Utilized as of September 30, 2019 Discount rates 5.29% to 5.64% Probabilities of payment for regulatory milestones 0% to 100% (1) Projected years of payment for regulatory milestones 2019 to 2023 Projected years of payment for commercial milestones Up to 4.25 years (1) One of the regulatory milestones was met during the three months ended September 30, 2019, requiring a payment in the amount of $7.0 million to be made in the fourth quarter of 2019. The maximum remaining potential payments related to the contingent consideration from the MyoScience Acquisition are $80.0 million . The change in the Company’s contingent consideration recorded at fair value using Level 3 measurements is as follows (in thousands): Fair Value Balance at December 31, 2018 $ — New financial liabilities entered into on date of MyoScience Acquisition (April 9, 2019) 28,470 Fair value adjustments and accretion 7,327 Balance at September 30, 2019 $ 35,797 Investments Short-term investments consist of asset-backed securities collateralized by credit card receivables, investment grade commercial paper and corporate bonds with maturities greater than three months, but less than one year. Long-term investments consist of asset-backed securities collateralized by credit card receivables and corporate bonds with maturities greater than one year. Net unrealized gains and losses from the Company’s short-term and long-term investments are reported in other comprehensive income (loss). At September 30, 2019 , all of the Company’s short-term investments are classified as available for sale investments and are determined to be Level 2 instruments, which are measured at fair value using standard industry models with observable inputs. The fair value of the commercial paper is measured based on a standard industry model that uses the three-month U.S. Treasury bill rate as an observable input. The fair value of the asset-backed securities and corporate bonds is principally measured or corroborated by trade data for identical issues in which related trading activity is not sufficiently frequent to be considered a Level 1 input or that of comparable securities. At September 30, 2019 , all short-term and long-term investments had an “A” or better rating by Standard & Poor’s. The following summarizes the Company’s investments at September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 Investments Cost Gross Gross Fair Value Short-term: Asset-backed securities $ 29,044 $ 60 $ — $ 29,104 Commercial paper 34,788 41 — 34,829 Corporate bonds 116,273 299 — 116,572 Subtotal 180,105 400 — 180,505 Long-term: Asset-backed securities 16,518 23 (7 ) 16,534 Corporate bonds 54,012 48 (17 ) 54,043 Subtotal 70,530 71 (24 ) 70,577 Total $ 250,635 $ 471 $ (24 ) $ 251,082 December 31, 2018 Investments Cost Gross Gross Fair Value Short-term: Asset-backed securities $ 34,873 $ — $ (33 ) $ 34,840 Commercial paper 45,035 — (30 ) 45,005 Corporate bonds 171,289 — (206 ) 171,083 Subtotal 251,197 — (269 ) 250,928 Long-term: Asset-backed securities 9,383 5 — 9,388 Corporate bonds 16,499 — (16 ) 16,483 Subtotal 25,882 5 (16 ) 25,871 Total $ 277,079 $ 5 $ (285 ) $ 276,799 Certain assets and liabilities are measured at fair value on a nonrecurring basis, including assets and liabilities acquired in a business combination, any related contingent consideration arising from an acquisition and long-lived assets, which would be recognized at fair value if deemed to be impaired or if reclassified as assets held for sale. The fair value in these instances would be determined using Level 3 inputs. TELA Bio, Inc. At December 31, 2018, the Company held a $14.1 million investment in convertible preferred B shares of TELA Bio, Inc., or TELA Bio, a privately-held surgical reconstruction company that markets its proprietary OviTex TM portfolio of products for ventral hernia repair and abdominal wall reconstruction. In June 2019, the Company made an additional cash investment of $1.6 million in TELA Bio’s convertible preferred B shares. In September 2019, the investment was deemed to be impaired when an offer was made to sell the Company’s shares in TELA Bio for an amount less than the Company’s carrying amount. The fair value of the investment was based on an initial public offering estimated price range less a discount for a lack of liquidity. The Company recognized an impairment charge of $5.4 million , which was recorded in other, net in its consolidated statements of operations for the three and nine months ended September 30, 2019. In the three and nine months ended September 30, 2018, the Company recorded a loss of $0.9 million on an unexercised purchase option in TELA Bio, which was recorded in other, net in its consolidated statements of operations. Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments, long-term investments and accounts receivable. The Company maintains its cash and cash equivalents with high-credit quality financial institutions. Such amounts may exceed federally-insured limits. As of September 30, 2019 , three wholesalers each accounted for over 10% of the Company’s accounts receivable, at 34% , 30% and 29% , respectively. At December 31, 2018 , three wholesalers each accounted for over 10% of the Company’s accounts receivable, at 32% , 32% and 29% , respectively. For additional information regarding the Company’s wholesalers, see Note 2 , Summary of Significant Accounting Policies . Revenues are primarily derived from major wholesalers and pharmaceutical companies that generally have significant cash resources. The Company performs ongoing credit evaluations of its customers as warranted and generally does not require collateral. Allowances for doubtful accounts receivable are maintained based on historical payment patterns, aging of accounts receivable and the Company’s actual write-off history. As of September 30, 2019 and December 31, 2018 , no allowances for doubtful accounts were deemed necessary by the Company on its accounts receivable. |
STOCK PLANS
STOCK PLANS | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
STOCK PLANS | STOCK PLANS Stock Incentive Plans In June 2019, the Company’s stockholders approved the Amended and Restated 2011 Stock Incentive Plan, or 2011 Plan. The 2011 Plan was amended to increase the number of shares of common stock authorized for issuance as equity awards under the plan by 3,000,000 shares. Stock-Based Compensation The Company recognized stock-based compensation expense in the periods presented as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Cost of goods sold $ 1,243 $ 1,179 $ 3,490 $ 3,431 Research and development 1,297 1,122 3,772 2,770 Selling, general and administrative 6,704 5,807 17,199 17,338 Total $ 9,244 $ 8,108 $ 24,461 $ 23,539 Stock-based compensation from: Stock options (employee awards) $ 6,257 $ 5,270 $ 16,509 $ 16,452 Stock options (consultant awards) 161 209 408 449 Restricted stock units (employee awards) 2,639 2,479 6,950 6,088 Employee stock purchase plan 187 150 594 550 Total $ 9,244 $ 8,108 $ 24,461 $ 23,539 Equity Awards The following tables contain information about the Company’s stock option and restricted stock unit, or RSU, activity for the nine months ended September 30, 2019 : Stock Options Number of Options Weighted Average Exercise Price Outstanding at December 31, 2018 5,722,818 $ 41.69 Granted 1,792,978 42.81 Exercised (251,169 ) 19.88 Forfeited (258,353 ) 41.51 Expired (125,316 ) 59.20 Outstanding at September 30, 2019 6,880,958 42.46 Restricted Stock Units Number of Units Weighted Average Grant Date Fair Value Unvested at December 31, 2018 577,964 $ 42.14 Granted 303,168 43.57 Vested (190,586 ) 45.56 Forfeited (49,611 ) 41.04 Unvested at September 30, 2019 640,935 41.88 The weighted average fair value of stock options granted during the nine months ended September 30, 2019 was $20.97 per share. The fair values of stock options granted were estimated using the Black-Scholes option valuation model with the following weighted average assumptions: Black-Scholes Weighted Average Assumption Nine Months Ended September 30, 2019 Expected dividend yield None Risk-free interest rate 2.02% Expected volatility 53.88% Expected term of options 5.22 years Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan, or ESPP, features two six-month offering periods per year, running from January 1 to June 30 and July 1 to December 31. Under the ESPP, employees may elect to contribute after-tax earnings to purchase shares at 85% of the closing fair market value of the Company’s common stock on either the offering date or the purchase date, whichever is less. During the nine months ended September 30, 2019 , 35,766 shares were purchased and issued through the ESPP. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Accumulated Other Comprehensive Income (Loss) The following table illustrates the changes in the balances of the Company’s accumulated other comprehensive income (loss) for the periods presented (in thousands): Nine Months Ended Net unrealized gains (losses) from available for sale investments: 2019 2018 Balance at beginning of period $ (280 ) $ (454 ) Other comprehensive income before reclassifications 727 213 Amounts reclassified from accumulated other comprehensive income (loss) — — Balance at end of period $ 447 $ (241 ) |
NET INCOME (LOSS) PER SHARE
NET INCOME (LOSS) PER SHARE | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
NET INCOME (LOSS) PER SHARE | NET INCOME (LOSS) PER SHARE Basic net income (loss) per share is calculated by dividing the net income (loss) attributable to common shares by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per common share is calculated by dividing the net income (loss) attributable to common shares by the weighted average number of common shares outstanding plus dilutive potential common shares outstanding during the period. Potential common shares include the shares of common stock issuable upon the exercise of outstanding stock options, the vesting of RSUs, the purchase of shares from the ESPP (using the treasury stock method) as well as the conversion of the excess conversion value on the 2022 Notes. As discussed in Note 9, Debt, the Company has the option to pay cash for the aggregate principal amount due upon the conversion of its 2022 Notes. Since it is the Company’s intent to settle the principal amount of its 2022 Notes in cash, the potentially dilutive effect of such notes on net income (loss) per share is computed under the treasury stock method. The Company settled the principal and conversion premium of its 2019 Notes in cash. Potential common shares are excluded from the diluted net income (loss) per share computation to the extent they would be antidilutive. Because the Company reported a net loss for each of the three and nine month periods ended September 30, 2019 and 2018 , no potentially dilutive securities have been included in the computation of diluted net loss per share for those periods. The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2019 and 2018 (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Numerator: Net loss $ (6,087 ) $ (640 ) $ (6,128 ) $ (8,756 ) Denominator: Weighted average common shares outstanding—basic and diluted 41,645 40,995 41,423 40,833 Net loss per share: Basic and diluted net loss per common share $ (0.15 ) $ (0.02 ) $ (0.15 ) $ (0.21 ) The following outstanding stock options, RSUs and ESPP purchase options are antidilutive in the periods presented (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Weighted average number of stock options 5,443 5,988 4,816 5,392 Weighted average number of RSUs 266 618 154 528 Weighted average ESPP purchase options 33 29 23 32 Total 5,742 6,635 4,993 5,952 |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
TAXES | INCOME TAXES Income (loss) before income taxes is as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Income (loss) before income taxes: Domestic $ (3,234 ) $ 1,839 $ 2,345 $ (7,382 ) Foreign (2,582 ) (2,541 ) (9,552 ) (1,366 ) Total loss before income taxes $ (5,816 ) $ (702 ) $ (7,207 ) $ (8,748 ) For the three months ended September 30, 2019 and 2018, the Company recorded income tax expense of $0.3 million and an income tax benefit of $0.1 million , respectively. For the nine months ended September 30, 2019 and 2018, the Company recorded an income tax benefit of $1.1 million and an income tax expense of less than $0.1 million , respectively. The income tax benefit for the nine months ended September 30, 2019 is primarily related to the MyoScience Acquisition and a $1.8 million reduction in the Company’s valuation allowance on its deferred tax assets due to the MyoScience Acquisition, partially offset by current state income taxes. Due to net operating losses, or NOLs, carried forward, and the repeal of the corporate minimum tax, no current federal income tax expense was recorded for 2018 or 2019. The utilization of the Company’s NOLs has not resulted in any deferred federal tax expense because there was a full valuation allowance recorded with respect to the NOLs. |
ACQUISITION-RELATED CHARGES AND
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET | (e) Discontinuation In June 2017, the Company’s board of directors approved the discontinuation of all future production of DepoCyt ® (U.S. and Canada) and DepoCyte ® (European Union) due to persistent technical issues specific to the DepoCyt(e) manufacturing process. As of June 30, 2017, the Company had ceased all production of DepoCyt(e). Cash payments related to the DepoCyt(e) manufacturing facility are expected to continue through the end of its lease term in August 2020. In April 2018, the Company received formal notice of the termination of a Supply Agreement and a Distribution Agreement (and all related agreements as subsequently amended) from Mundipharma International Corporation Limited and Mundipharma Medical Company, respectively (collectively, “Mundipharma”). The Company is currently engaged in settlement discussions with Mundipharma. Summary of Acquisition-Related Restructuring Activities and DepoCyt(e) Discontinuation Costs At January 1, 2019, there was a balance sheet reclassification from the lease cost reserves related to the DepoCyt(e) discontinuation to lease liabilities in the amount of $1.5 million , recognized as part of the transition to the ASU 2016-02. See Note 2, Summary of Significant Accounting Policies , for more information. The Company’s acquisition-related restructuring and DepoCyt(e) discontinuation costs as of September 30, 2019 are summarized below (in thousands): Acquisition-Related Separation Costs Acquisition-Related Asset Write-Downs DepoCyt(e) Lease Costs Asset Retirement Obligations, Other Restructuring and Discontinuation Costs Total Balance at December 31, 2018 $ — $ — $ 1,970 $ 282 $ 2,252 Charges incurred 480 193 — 167 840 Cash payments made (321 ) — — (307 ) (628 ) Other, including non-cash activity — (193 ) — — (193 ) Reclassifications — — (1,970 ) 455 (1,515 ) Balance at September 30, 2019 $ 159 $ — $ — $ 597 $ 756 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Litigation From time to time, the Company has been and may again become involved in legal proceedings arising in the ordinary course of its business, including those related to patents, product liability and government investigations. Except as described below, the Company is not presently a party to any legal proceedings which it believes to be material, and is not aware of any pending or threatened litigation against the Company which it believes could have a material adverse effect on its business, operating results, financial condition or cash flows. In April 2015, the Company received a subpoena from the U.S. Department of Justice, U.S. Attorney’s Office for the District of New Jersey, requiring the production of a broad range of documents pertaining to marketing and promotional practices related to EXPAREL. The Company is cooperating with the government’s inquiry. The Company can make no assurances as to the time or resources that will need to be devoted to this inquiry or its final outcome, or the impact, if any, of this inquiry or any proceedings on its business, financial condition, results of operations and cash flows. |
Subsequent Events (Notes)
Subsequent Events (Notes) | 3 Months Ended |
Dec. 31, 2019 | |
Subsequent Event [Line Items] | |
Subsequent Events [Text Block] | NOTE 17—SUBSEQUENT EVENTS Contingent Consideration In November 2019, the Company received new regulatory information and now expects to achieve an additional $10.0 million contingent regulatory milestone related to the MyoScience Acquisition, which can be made in either cash or shares of the Company’s common stock, or a combination thereof, at the election of MyoScience shareholders. As a result, in the fourth quarter of 2019, the Company expects to record a charge to acquisition-related charges of approximately $9.0 million . For more information regarding contingent milestone payments related to the MyoScience Acquisition, refer to Note 4, MyoScience Acquisition . |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation These interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP, and in accordance with the rules and regulations of the United States Securities and Exchange Commission, or SEC, for interim reporting. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in complete annual financial statements have been condensed or omitted. Therefore, these interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . The condensed consolidated financial statements at September 30, 2019 , and for the three and nine month periods ended September 30, 2019 and 2018 , are unaudited, but include all adjustments (consisting of only normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the financial information set forth herein in accordance with GAAP. The condensed consolidated balance sheet at December 31, 2018 is derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . The condensed consolidated financial statements as presented reflect certain reclassifications from previously issued financial statements to conform to the current year presentation. The accounts of wholly-owned subsidiaries are included in the condensed consolidated financial statements. Intercompany accounts and transactions have been eliminated in consolidation. The results of operations for these interim periods are not necessarily indicative of results that may be expected for any other interim periods or for the full year. |
Concentration of Major Customers | Concentration of Major Customers The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers (including AmerisourceBergen Health Corporation, Cardinal Health, Inc. and McKesson Drug Company), but shipments of the product are sent directly to individual accounts, such as hospitals, ambulatory surgery centers and individual doctors. The Company also sells EXPAREL directly to ambulatory surgery centers and physicians. The Company sells its bupivacaine liposome injectable suspension for use in animals to a third party licensee and sells iovera° directly to end users. The table below includes the percentage of revenue comprised by the Company’s three largest wholesalers in each period presented: Three Months Ended Nine Months Ended 2019 2018 2019 2018 Largest wholesaler 34% 34% 34% 34% Second largest wholesaler 29% 30% 29% 30% Third largest wholesaler 27% 26% 26% 26% Total 90% 90% 89% 90% |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-02, Leases (Topic 842) , and subsequently issued clarifications and corrections to the update by issuing ASU 2018-10 in July 2018. This update required lessees to recognize lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous authoritative guidance. For income statement purposes, the new standard retained a dual model similar to Accounting Standards Codification, or ASC, 840, requiring leases to be classified as either operating or financing. Operating leases continue to result in straight-line expense while financing leases result in a front-loaded expense pattern (similar to previous accounting guidance by lessees for operating and capital leases, respectively, under ASC 840). The Company adopted ASU 2016-02 on January 1, 2019 using the effective date method. There were practical expedients available to the Company at transition that it elected to apply upon adoption. The Company did not re-assess (i) whether its contracts contained a lease under the new definition of a lease and (ii) the classification of those leases. There were no initial direct costs previously capitalized on the consolidated balance sheet. In addition, the Company applied hindsight in the determination of the lease terms, in the assessment of the likelihood that a lease renewal, termination or purchase option will be exercised, and in the assessment of any potential impairments that existed on the right-of-use, or ROU, assets recognized at adoption. The Company also elected not to recognize a ROU asset and lease liability for those leases with a remaining lease term of 12 months or less. At adoption on January 1, 2019, the lease liability was equal to the present value of future lease payments and a ROU asset was recorded based on the lease liability, adjusted for items such as prepaid and accrued lease payments. The Company recorded $36.5 million of lease liabilities and $27.6 million of ROU assets as of January 1, 2019, the difference representing previously recorded lease-related assets and liabilities. There was a cumulative-effect adjustment to retained earnings of $0.2 million upon adoption. Refer to Note 7, Leases , for further information on the Company’s existing leases. The lease liability recognized upon adoption was based upon the present value of the sum of the remaining minimum lease payments (as previously identified under ASC 840), determined using the discount rate as of the date of adoption. The discount rate was based on the Company’s incremental borrowing rate on a collateralized basis over a similar remaining term and in a similar economic environment. Recent Accounting Pronouncements Not Adopted as of September 30, 2019 In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. Entities will now use forward-looking information to better form their credit loss estimates. This update also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an entity’s portfolio. This standard will become effective for the Company beginning January 1, 2020, with early adoption permitted. The Company does not expect there to be a significant impact from the adoption of ASU 2016-13 on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework. The purpose of the update is to improve the effectiveness of the fair value measurement disclosures that allows for clear communication of information that is most important to the users of financial statements. There were certain required disclosures that have been removed or modified. In addition, the update added the following disclosures: (i) changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and (ii) the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The standard will become effective for the Company beginning January 1, 2020. The Company does not expect there to be a significant impact from the adoption of ASU 2018-13 on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The update provides guidance to determine which implementation costs to capitalize as they relate to the service contract and which costs to expense. In addition, the update further defines the term of the hosting arrangement to include the non-cancelable period of the arrangement plus periods covered by (i) an option to extend the arrangement if the customer is reasonably certain to exercise that option; (ii) an option to terminate the arrangement if the customer is reasonably certain not to exercise the termination option and (iii) an option to extend (or not to terminate) the arrangement in which exercise of the option is in the control of the vendor. Any expense related to the capitalized implementation costs should be recorded in the same financial statement line item in the consolidated statements of operations as the fees associated with the hosting element of the arrangement, and the payments for capitalized implementation costs should be classified in the same manner as payments made for fees associated with the hosting element in the consolidated statements of cash flows. This standard will become effective for the Company beginning January 1, 2020. The amendments may be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company expects to apply ASU 2018-15 on a prospective basis. The Company will apply this standard to future implementation costs incurred. The impact of ASU 2018-15 will be dependent upon future projects entered into by the Company subsequent to the date of adoption. In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which provides amendments to the recognition and measurement of certain financial assets and financial liabilities. One of those amendments requires that equity securities without readily determinable fair values accounted for under the measurement alternative be re-measured when an orderly transaction is identified for an identical or similar investment of the same issuer. This standard will become effective for the Company beginning January 1, 2020. The Company does not expect there to be a significant impact from the adoption of ASU 2019-04 on its consolidated financial statements. Other pronouncements issued by the FASB or other authoritative accounting standards groups with future effective dates are either not applicable or not significant to the consolidated financial statements of the Company. |
Leases | Leases Effective January 1, 2019, the Company recognizes ROU assets and lease liabilities at the commencement of its lease agreements. The leases are evaluated at commencement to determine whether they should be classified as operating or financing leases. Lease costs associated with operating leases are recognized on a straight-line basis, while lease costs for financing leases are recognized over the lease term using the effective interest method. To date, the Company does not have any financing leases. The amount of ROU assets and lease liabilities to be recognized is impacted by the type of lease payments, the lease term and the incremental borrowing rate. Variable lease payments are not included at commencement and are recognized in the period in which they are incurred. The lease term is based on the contractual term and is adjusted for any renewal options or termination rights that are reasonably certain to be exercised. The incremental borrowing rate is based on the rate the Company estimates it would pay on a collateralized basis over a similar term in a similar economic environment. |
Acquisitions [Policy Text Block] | Acquisitions In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values with some exceptions. Assets acquired and liabilities assumed in a business combination that arise from contingencies are generally recognized at fair value. If fair value cannot be determined, the asset or liability is recognized if probable and reasonably estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair value measures that do not reflect the Company’s intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company’s condensed consolidated financial statements after the date of the acquisition. If the Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an acquisition of assets rather than as a business combination and, therefore, no goodwill would be recorded. |
Contingent Consideration [Policy Text Block] | Contingent Consideration Subsequent to an acquisition, the Company measures contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as acquisition-related charges. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales, costs of goods sold and regulatory approvals. In the absence of new information, changes in fair value reflect the passage of time towards achievement of the milestones, and are accrued based on an accretion schedule. |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Intangible Assets Intangible assets with definite useful lives are amortized on a straight-line basis over their estimated useful lives and are reviewed for impairment if certain events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Intangible assets are recorded at cost, net of accumulated amortization. The Company evaluates the recoverability of intangible assets periodically and takes into account events and circumstances which may indicate that an impairment exists. |
Segment Reporting, Policy [Policy Text Block] | Segment Reporting The Company is managed and operated as a single business focused on the discovery, development, manufacture, marketing, distribution and sale of non-opioid pain management options. The Company is managed by a single management team, and, consistent with its organizational structure, the Chief Executive Officer and Chairman manages and allocates resources at a consolidated level. Accordingly, the Company views its business as one reportable operating segment to evaluate performance, allocate resources, set operational targets and forecast its future period financial results. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of percentage of revenue comprised by the three largest customers (i.e. wholesalers or commercial partners) | The table below includes the percentage of revenue comprised by the Company’s three largest wholesalers in each period presented: Three Months Ended Nine Months Ended 2019 2018 2019 2018 Largest wholesaler 34% 34% 34% 34% Second largest wholesaler 29% 30% 29% 30% Third largest wholesaler 27% 26% 26% 26% Total 90% 90% 89% 90% |
REVENUE (Tables)
REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregated Revenue | The following table represents disaggregated net product sales in the periods presented as follows (in thousands): Three Months Ended Nine Months Ended Net Product Sales 2019 2018 2019 2018 EXPAREL / bupivacaine liposome injectable suspension $ 101,711 $ 82,708 $ 292,406 $ 237,713 iovera° 2,639 — 4,674 — Total net product sales $ 104,350 $ 82,708 $ 297,080 $ 237,713 |
MYOSCIENCE ACQUISITION (Tables)
MYOSCIENCE ACQUISITION (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Business Combinations [Abstract] | |
Schedule of Business Acquisition | CryoTech results from the acquisition date of April 10, 2019 through September 30, 2019, which are included in the condensed consolidated statements of operations, are as follows (in thousands): Classification in Condensed Consolidated Statements of Operations Acquisition Date Through September 30, 2019 Total revenues $ 4,674 Net loss $ (5,555 ) The total consideration for the MyoScience Acquisition was $147.5 million , which consisted of the following (in thousands): Purchase Price Amount Cash paid, adjusted for working capital items $ 119,038 Fair value of contingent consideration 28,470 Total $ 147,508 Amounts Recognized at the Acquisition Date (Unaudited) ASSETS ACQUIRED Current assets $ 5,275 Non-current assets (other than intangible assets) 1,044 Intangible assets (excluding goodwill) 110,090 Total assets acquired (excluding goodwill) $ 116,409 LIABILITIES ASSUMED Current liabilities $ 4,436 Deferred tax liabilities, net 1,828 Other non-current liabilities 144 Total liabilities assumed 6,408 Total identifiable net assets acquired 110,001 Goodwill 37,507 Total consideration transferred $ 147,508 |
Unaudited Pro Forma Summary of Operations | The following table shows the unaudited pro forma summary of operations for the three months ended September 30, 2018 and the nine months ended September 30, 2019 and 2018, as if the MyoScience Acquisition had occurred on January 1, 2018. This pro forma information does not purport to represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2018, and is not indicative of what such results would be expected for any future period (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2018 2019 2018 Total revenues $ 84,916 $ 301,051 $ 245,721 Net loss $ (6,944 ) $ (10,633 ) $ (27,663 ) Pro forma basic and diluted net loss per share $ (0.17 ) $ (0.26 ) $ (0.68 ) |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of components of inventories | The components of inventories, net are as follows (in thousands): September 30, December 31, 2019 2018 Raw materials $ 18,798 $ 19,193 Work-in-process 17,472 9,711 Finished goods 23,968 19,665 Total $ 60,238 $ 48,569 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets summarized by major category | Fixed assets, net, summarized by major category, consist of the following (in thousands): September 30, December 31, 2019 2018 Machinery and equipment $ 68,342 $ 67,431 Leasehold improvements 60,355 57,955 Computer equipment and software 8,381 8,131 Office furniture and equipment 1,625 1,548 Construction in progress 38,421 35,163 Total 177,124 170,228 Less: accumulated depreciation (72,268 ) (61,558 ) Fixed assets, net $ 104,856 $ 108,670 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Summary of operating lease cost and other operating lease information | The weighted average remaining lease term and the weighted average discount rate are summarized as follows: September 30, 2019 Weighted average remaining lease term 9.66 years Weighted average discount rate 7.62% Three Months Ended Nine Months Ended September 30, September 30, Operating Lease Costs 2019 2018 2019 2018 Fixed lease costs $ 1,585 $ 2,659 4,544 5,750 Variable lease costs 403 495 1,233 1,305 Total $ 1,988 $ 3,154 $ 5,777 $ 7,055 Supplemental cash flow information related to operating leases is as follows (in thousands): Nine Months Ended September 30, 2019 Cash paid for operating lease liabilities, net of lease incentive $ 5,247 Right-of-use assets recorded in exchange for lease obligations $ 38,419 |
Schedule of maturities of operating lease liabilities | Maturities of the Company’s operating lease liabilities are as follows (in thousands): Year Aggregate Minimum Payments Due 2019 (remaining three months) $ 2,039 2020 7,662 2021 5,359 2022 5,486 2023 5,616 2024 through 2030 37,208 Total lease payments 63,370 Less: imputed interest (19,445 ) Total operating lease liabilities $ 43,925 |
Schedule of maturities of operating lease liabilities | The Company has entered into three lease agreements (not included in the table above) for which there are future obligations but the leases have not yet commenced as of September 30, 2019 (in thousands): Year Aggregate Minimum Payments Due 2019 (remaining three months) $ 27 2020 2,607 2021 4,878 2022 4,937 2023 5,081 2024 through 2030 35,848 Total future lease payments $ 53,378 |
Schedule of maturities of operating lease liabilities | As of December 31, 2018, aggregate annual minimum payments due under the Company’s lease obligations were as follows (in thousands): Year Aggregate Minimum Payments Due 2019 $ 8,140 2020 7,621 2021 5,295 2022 5,417 2023 5,543 2024 through 2030 14,329 Total $ 46,345 |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The change in the carrying value of the Company’s goodwill is summarized as follows (in thousands): Carrying Value of Goodwill Balance at December 31, 2018 $ 62,040 Goodwill arising from the MyoScience Acquisition 37,507 Balance at September 30, 2019 $ 99,547 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of composition of the Company's debt and financing obligations | The total debt composition of the 2022 Notes is as follows (in thousands): September 30, December 31, 2019 2018 2.375% convertible senior notes due 2022 $ 345,000 $ 345,000 Deferred financing costs (4,577 ) (5,850 ) Discount on debt (38,342 ) (48,558 ) Total debt, net of debt discount and deferred financing costs $ 302,081 $ 290,592 |
Schedule of total interest expense recognized related to the Notes | The following table sets forth the total interest expense recognized in the periods presented (dollar amounts in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Contractual interest expense $ 2,048 $ 2,051 $ 6,146 $ 6,153 Amortization of debt issuance costs 429 411 1,273 1,219 Amortization of debt discount 3,467 3,228 10,216 9,512 Capitalized interest (Note 6) (4 ) (48 ) (4 ) (689 ) Total $ 5,940 $ 5,642 $ 17,631 $ 16,195 Effective interest rate on convertible senior notes 7.81 % 7.81 % 7.81 % 7.81 % |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of carrying amount and fair value of the long-term debt | The carrying amount and fair values of the Company’s convertible senior notes and acquisition-related contingent consideration are as follows (in thousands): Financial Liabilities Carrying Value Fair Value Measurements Using September 30, 2019 Level 1 Level 2 Level 3 2.375% convertible senior notes due 2022 (1)(2) $ 302,081 $ — $ 340,472 $ — Acquisition-related contingent consideration (3) $ 35,797 $ — $ — $ 35,797 (1) The closing price of the Company’s common stock was $38.07 per share at September 30, 2019 compared to a conversion price of $66.89 per share. Currently, the conversion price is above the stock price. The maximum conversion premium that can be due on the 2022 Notes is approximately 5.2 million shares of the Company’s common stock, which assumes no increases in the conversion rate for certain corporate events. (2) Reported at historical cost. (3) Reported at fair value on a recurring basis. |
Schedule of key assumptions used in the valuation of contingent consideration | The following table includes the key assumptions used in the valuation of the Company’s contingent consideration: Assumption Ranges Utilized as of September 30, 2019 Discount rates 5.29% to 5.64% Probabilities of payment for regulatory milestones 0% to 100% (1) Projected years of payment for regulatory milestones 2019 to 2023 Projected years of payment for commercial milestones Up to 4.25 years (1) One of the regulatory milestones was met during the three months ended September 30, 2019, requiring a payment in the amount of $7.0 million to be made in the fourth quarter of 2019. |
Schedule of change in contingent consideration recorded at fair value using Level 3 measurements | The change in the Company’s contingent consideration recorded at fair value using Level 3 measurements is as follows (in thousands): Fair Value Balance at December 31, 2018 $ — New financial liabilities entered into on date of MyoScience Acquisition (April 9, 2019) 28,470 Fair value adjustments and accretion 7,327 Balance at September 30, 2019 $ 35,797 |
Schedule of short-term investments | The following summarizes the Company’s investments at September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 Investments Cost Gross Gross Fair Value Short-term: Asset-backed securities $ 29,044 $ 60 $ — $ 29,104 Commercial paper 34,788 41 — 34,829 Corporate bonds 116,273 299 — 116,572 Subtotal 180,105 400 — 180,505 Long-term: Asset-backed securities 16,518 23 (7 ) 16,534 Corporate bonds 54,012 48 (17 ) 54,043 Subtotal 70,530 71 (24 ) 70,577 Total $ 250,635 $ 471 $ (24 ) $ 251,082 December 31, 2018 Investments Cost Gross Gross Fair Value Short-term: Asset-backed securities $ 34,873 $ — $ (33 ) $ 34,840 Commercial paper 45,035 — (30 ) 45,005 Corporate bonds 171,289 — (206 ) 171,083 Subtotal 251,197 — (269 ) 250,928 Long-term: Asset-backed securities 9,383 5 — 9,388 Corporate bonds 16,499 — (16 ) 16,483 Subtotal 25,882 5 (16 ) 25,871 Total $ 277,079 $ 5 $ (285 ) $ 276,799 |
STOCK PLANS (Tables)
STOCK PLANS (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule of recognized stock-based compensation in consolidated statements of operations | The Company recognized stock-based compensation expense in the periods presented as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Cost of goods sold $ 1,243 $ 1,179 $ 3,490 $ 3,431 Research and development 1,297 1,122 3,772 2,770 Selling, general and administrative 6,704 5,807 17,199 17,338 Total $ 9,244 $ 8,108 $ 24,461 $ 23,539 Stock-based compensation from: Stock options (employee awards) $ 6,257 $ 5,270 $ 16,509 $ 16,452 Stock options (consultant awards) 161 209 408 449 Restricted stock units (employee awards) 2,639 2,479 6,950 6,088 Employee stock purchase plan 187 150 594 550 Total $ 9,244 $ 8,108 $ 24,461 $ 23,539 |
Schedule of the Company's stock option activity and related information | The following tables contain information about the Company’s stock option and restricted stock unit, or RSU, activity for the nine months ended September 30, 2019 : Stock Options Number of Options Weighted Average Exercise Price Outstanding at December 31, 2018 5,722,818 $ 41.69 Granted 1,792,978 42.81 Exercised (251,169 ) 19.88 Forfeited (258,353 ) 41.51 Expired (125,316 ) 59.20 Outstanding at September 30, 2019 6,880,958 42.46 Restricted Stock Units Number of Units Weighted Average Grant Date Fair Value Unvested at December 31, 2018 577,964 $ 42.14 Granted 303,168 43.57 Vested (190,586 ) 45.56 Forfeited (49,611 ) 41.04 Unvested at September 30, 2019 640,935 41.88 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule of accumulated other comprehensive income (loss) | The following table illustrates the changes in the balances of the Company’s accumulated other comprehensive income (loss) for the periods presented (in thousands): Nine Months Ended Net unrealized gains (losses) from available for sale investments: 2019 2018 Balance at beginning of period $ (280 ) $ (454 ) Other comprehensive income before reclassifications 727 213 Amounts reclassified from accumulated other comprehensive income (loss) — — Balance at end of period $ 447 $ (241 ) |
NET INCOME (LOSS) PER SHARE (Ta
NET INCOME (LOSS) PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of computation of basic and diluted loss per share | The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2019 and 2018 (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Numerator: Net loss $ (6,087 ) $ (640 ) $ (6,128 ) $ (8,756 ) Denominator: Weighted average common shares outstanding—basic and diluted 41,645 40,995 41,423 40,833 Net loss per share: Basic and diluted net loss per common share $ (0.15 ) $ (0.02 ) $ (0.15 ) $ (0.21 ) |
Schedule of potential dilutive effect of the securities excluded from the calculation of diluted loss per share | The following outstanding stock options, RSUs and ESPP purchase options are antidilutive in the periods presented (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Weighted average number of stock options 5,443 5,988 4,816 5,392 Weighted average number of RSUs 266 618 154 528 Weighted average ESPP purchase options 33 29 23 32 Total 5,742 6,635 4,993 5,952 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign | Income (loss) before income taxes is as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Income (loss) before income taxes: Domestic $ (3,234 ) $ 1,839 $ 2,345 $ (7,382 ) Foreign (2,582 ) (2,541 ) (9,552 ) (1,366 ) Total loss before income taxes $ (5,816 ) $ (702 ) $ (7,207 ) $ (8,748 ) |
ACQUISITION-RELATED CHARGES A_2
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET | Acquisition-Related Separation Costs Acquisition-Related Asset Write-Downs DepoCyt(e) Lease Costs Asset Retirement Obligations, Other Restructuring and Discontinuation Costs Total Balance at December 31, 2018 $ — $ — $ 1,970 $ 282 $ 2,252 Charges incurred 480 193 — 167 840 Cash payments made (321 ) — — (307 ) (628 ) Other, including non-cash activity — (193 ) — — (193 ) Reclassifications — — (1,970 ) 455 (1,515 ) Balance at September 30, 2019 $ 159 $ — $ — $ 597 $ 756 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) | 9 Months Ended |
Sep. 30, 2019product | |
Sales Revenue, Net | Product Concentration Risk | |
Concentration Risk [Line Items] | |
Concentration of products (in products) | 2 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019customersegment | Sep. 30, 2018 | |
Concentration of Major Customers | ||||
Number of reportable segments | segment | 1 | |||
Concentration risk by major customer | ||||
Concentration of Major Customers | ||||
Number of major customers | customer | 3 | |||
Net revenue | Concentration risk by major customer | ||||
Concentration of Major Customers | ||||
Percentage of revenue from customers to total revenue | 90.00% | 90.00% | 89.00% | 90.00% |
Net revenue | Concentration risk by major customer | Largest wholesaler | ||||
Concentration of Major Customers | ||||
Percentage of revenue from customers to total revenue | 34.00% | 34.00% | 34.00% | 34.00% |
Net revenue | Concentration risk by major customer | Second largest wholesaler | ||||
Concentration of Major Customers | ||||
Percentage of revenue from customers to total revenue | 29.00% | 30.00% | 29.00% | 30.00% |
Net revenue | Concentration risk by major customer | Third largest wholesaler | ||||
Concentration of Major Customers | ||||
Percentage of revenue from customers to total revenue | 27.00% | 26.00% | 26.00% | 26.00% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES New Accounting Pronouncements or change in Accounting Policy (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Total operating lease liabilities | $ 43,925 | ||
ROU asset | $ 35,756 | $ 0 | |
Accounting Standards Update 2016-02 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Total operating lease liabilities | $ 36,500 | ||
ROU asset | 27,600 | ||
Cumulative-effect adjustment to retained earnings | $ 200 |
REVENUE (Details)
REVENUE (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Total net product sales | $ 104,350 | $ 82,708 | $ 297,080 | $ 237,713 |
EXPAREL/bupivacaine liposome injectable suspension [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total net product sales | 101,711 | 82,708 | 292,406 | 237,713 |
iovera° | ||||
Disaggregation of Revenue [Line Items] | ||||
Total net product sales | $ 2,639 | $ 0 | $ 4,674 | $ 0 |
Minimum | ||||
Disaggregation of Revenue [Line Items] | ||||
Accounts Receivable, Additional Narrative Disclosure | P0D | |||
Maximum | ||||
Disaggregation of Revenue [Line Items] | ||||
Accounts Receivable, Additional Narrative Disclosure | P37D |
MYOSCIENCE ACQUISITION (Details
MYOSCIENCE ACQUISITION (Details) - USD ($) $ in Thousands | Apr. 09, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Business Acquisition [Line Items] | |||||
Income (loss) before income taxes | $ (5,816) | $ (702) | $ (7,207) | $ (8,748) | |
Valuation allowance on deferred tax assets | 1,800 | 1,800 | |||
Acquisition-related contingent consideration | 7,000 | 7,000 | |||
Myoscience Acquisition | |||||
Business Acquisition [Line Items] | |||||
Initial cash payment | 120,000 | ||||
Fair value of contingent consideration | $ 28,470 | ||||
Contingent consideration | 100,000 | ||||
Contingent consideration maximum amount payable in shares | $ 25,000 | ||||
Payment term | 60 days | ||||
Total consideration transferred | 147,508 | ||||
Net income (loss) | $ (6,944) | (10,633) | $ (27,663) | ||
Acquisition-related contingent consideration | 35,800 | 35,800 | |||
Scenario, Forecast | Achievement of Regulatory Milestone | |||||
Business Acquisition [Line Items] | |||||
Acquisition-related contingent consideration | $ 5,000 | $ 5,000 |
MYOSCIENCE ACQUISITION - Schedu
MYOSCIENCE ACQUISITION - Schedule of Business Acquisition (Details) - USD ($) $ in Thousands | Apr. 09, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Business Acquisition [Line Items] | ||||||||
Acquisition-related contingent consideration | $ 7,000 | $ 7,000 | ||||||
Goodwill | 99,547 | 99,547 | $ 62,040 | |||||
Revenues | 104,685 | $ 83,448 | 298,602 | $ 242,163 | ||||
Myoscience Acquisition | ||||||||
Business Acquisition [Line Items] | ||||||||
Acquisition-related contingent consideration | 35,800 | 35,800 | ||||||
Goodwill, Translation and Purchase Accounting Adjustments | 1,000 | |||||||
Cash paid, adjusted for working capital items | $ 119,038 | |||||||
Fair value of contingent consideration | 28,470 | |||||||
Total | 147,508 | |||||||
Current assets | 5,275 | |||||||
Non-current assets (other than intangible assets) | 1,044 | |||||||
Intangible assets (excluding goodwill) | 110,090 | |||||||
Total assets acquired (excluding goodwill) | 116,409 | |||||||
Current liabilities | 4,436 | |||||||
Deferred tax liabilities, net | 1,828 | |||||||
Other non-current liabilities | 144 | |||||||
Total liabilities assumed | 6,408 | |||||||
Total identifiable net assets acquired | 110,001 | |||||||
Goodwill | 37,507 | |||||||
Total consideration transferred | $ 147,508 | |||||||
Revenues | $ 4,674 | |||||||
Net loss | $ (5,555) | |||||||
Achievement of Regulatory Milestone [Domain] | ||||||||
Business Acquisition [Line Items] | ||||||||
Acquisition-related contingent consideration | 7,000 | 7,000 | ||||||
Scenario, Forecast | Achievement of Regulatory Milestone [Member] | ||||||||
Business Acquisition [Line Items] | ||||||||
Acquisition-related contingent consideration | $ 5,000 | $ 5,000 | ||||||
Scenario, Forecast | Subsequent Event | Achievement of Development and Commercial Milestones | ||||||||
Business Acquisition [Line Items] | ||||||||
Acquisition-related contingent consideration | $ 10,000 |
MYOSCIENCE ACQUISITION - Unaudi
MYOSCIENCE ACQUISITION - Unaudited Pro Forma Summary of Operations (Details) - Myoscience Acquisition - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Business Acquisition [Line Items] | |||
Total revenues | $ 84,916 | $ 301,051 | $ 245,721 |
Net income (loss) | $ (6,944) | $ (10,633) | $ (27,663) |
Business Acquisition, Pro Forma Earnings Per Share, Basic And Diluted | $ (170) | $ (260) | $ (680) |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Raw materials | $ 18,798 | $ 19,193 |
Work-in-process | 17,472 | 9,711 |
Finished goods | 23,968 | 19,665 |
Total | 60,238 | $ 48,569 |
Maximum [Member] | ||
Inventory Valuation Reserves | $ 10,500 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
FIXED ASSETS | |||||
Total | $ 177,124 | $ 177,124 | $ 170,228 | ||
Less: accumulated depreciation | (72,268) | (72,268) | (61,558) | ||
Fixed assets, net | 104,856 | 104,856 | 108,670 | ||
Depreciation expense | 3,600 | $ 3,500 | 10,700 | $ 9,100 | |
Capitalized interest (Note 4) | $ 100 | $ 700 | |||
Foreign property, plant and equipment, net | 65,100 | 65,100 | 64,600 | ||
Increase (Decrease) in Asset Retirement Obligations | 300 | ||||
Asset Retirement Obligation, Accretion Expense | 100 | 200 | |||
Machinery and equipment | |||||
FIXED ASSETS | |||||
Total | 68,342 | 68,342 | 67,431 | ||
Leasehold improvements | |||||
FIXED ASSETS | |||||
Total | 60,355 | 60,355 | 57,955 | ||
Computer equipment and software | |||||
FIXED ASSETS | |||||
Total | 8,381 | 8,381 | 8,131 | ||
Office furniture and equipment | |||||
FIXED ASSETS | |||||
Total | 1,625 | 1,625 | 1,548 | ||
Construction in progress | |||||
FIXED ASSETS | |||||
Total | 38,421 | 38,421 | $ 35,163 | ||
Capitalized interest (Note 4) | $ 100 | $ 100 |
LEASES -Narrative (Details)
LEASES -Narrative (Details) | 9 Months Ended |
Sep. 30, 2019ft² | |
Lease term renewal | 4 years |
Weighted average remaining lease term | 9 years 7 months 28 days |
Weighted average discount rate | 7.62% |
Minimum | |
Term of contract | 1 year |
Maximum | |
Term of contract | 11 years |
Fremont, California | Building | |
Operating lease, area (in sq ft) | 20,000 |
LEASES -Summary of operating le
LEASES -Summary of operating lease cost and other operating lease information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating lease costs: | ||||
Fixed lease costs | $ 1,585 | $ 2,659 | $ 4,544 | $ 5,750 |
Variable lease costs | 403 | 495 | 1,233 | 1,305 |
Total | $ 1,988 | $ 3,154 | 5,777 | $ 7,055 |
Cash paid for operating lease liabilities, net of lease incentive | ||||
Right-of-use assets recorded in exchange for lease obligations | $ 5,247 | |||
Weighted average remaining lease term | 9 years 7 months 28 days | 9 years 7 months 28 days | ||
Weighted average discount rate | 7.62% | 7.62% | ||
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | $ 38,419 |
LEASES -Schedule of maturities
LEASES -Schedule of maturities of operating lease liabilities (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
2019 (remaining three months) | $ 2,039 |
2020 | 7,662 |
2021 | 5,359 |
2022 | 5,486 |
2023 | 5,616 |
2024 through 2030 | 37,208 |
Total lease payments | 63,370 |
Less: imputed interest | (19,445) |
Total operating lease liabilities | $ 43,925 |
LEASES -Schedule of maturitie_2
LEASES -Schedule of maturities of operating lease liabilities (lease not yet commenced) (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($)contract | |
Leases [Abstract] | |
Number of leases not yet commenced | contract | 3 |
2019 (remaining three months) | $ 27 |
2020 | 2,607 |
2021 | 4,878 |
2022 | 4,937 |
2023 | 5,081 |
2024 through 2030 | 35,848 |
Total future lease payments | $ 53,378 |
LEASES -Schedule of maturitie_3
LEASES -Schedule of maturities of operating lease liabilities (prior year) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 8,140 |
2020 | 7,621 |
2021 | 5,295 |
2022 | 5,417 |
2023 | 5,543 |
2024 through 2030 | 14,329 |
Total | $ 46,345 |
GOODWILL AND INTANGIBLE ASSET_2
GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Apr. 09, 2019 | Dec. 31, 2018 | |
Goodwill | ||||||
Goodwill recorded in connection with the acquisition | $ 99,547,000 | $ 99,547,000 | $ 62,040,000 | |||
Intangible assets, net | 106,354,000 | 106,354,000 | 0 | |||
Amortization of acquired intangible assets | 1,967,000 | $ 0 | 3,736,000 | $ 0 | ||
Amortization expense, remainder of fiscal year | 2,000,000 | 2,000,000 | ||||
Amortization expense, 2020-2032 | 7,900,000 | 7,900,000 | ||||
Amortization expense, 2033 | 2,200,000 | 2,200,000 | ||||
Upon first commercial sale in the United States | ||||||
Goodwill | ||||||
Milestone payments for EXPAREL agreed in connection with acquisition | 10,000,000 | 10,000,000 | ||||
Upon first commercial sale in a major EU country (United Kingdom, France, Germany, Italy and Spain) | ||||||
Goodwill | ||||||
Milestone payments for EXPAREL agreed in connection with acquisition | 4,000,000 | 4,000,000 | ||||
When annual net sales collected reach $100.0 million | ||||||
Goodwill | ||||||
Milestone payments for EXPAREL agreed in connection with acquisition | 8,000,000 | 8,000,000 | ||||
Annual net sales threshold | 100,000,000 | 100,000,000 | ||||
When annual net sales collected reach $250.0 million | ||||||
Goodwill | ||||||
Milestone payments for EXPAREL agreed in connection with acquisition | 8,000,000 | 8,000,000 | ||||
Annual net sales threshold | 250,000,000 | 250,000,000 | ||||
When annual net sales collected reach $500.0 million | ||||||
Goodwill | ||||||
Milestone payments for EXPAREL agreed in connection with acquisition | 32,000,000 | 32,000,000 | ||||
Annual net sales threshold | $ 500,000,000 | $ 500,000,000 | ||||
Skye Pharma Holding Inc. | ||||||
Goodwill | ||||||
Total Milestone Payments Yet to be Paid for Sale of Product in Connection with Acquisition | $ 36,000,000 | |||||
Myoscience Acquisition | ||||||
Goodwill | ||||||
Goodwill recorded in connection with the acquisition | $ 37,507,000 |
GOODWILL AND INTANGIBLE ASSET_3
GOODWILL AND INTANGIBLE ASSETS - Goodwill Rollforward (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Goodwill [Roll Forward] | |
Balance at December 31, 2018 | $ 62,040 |
Goodwill arising from the MyoScience Acquisition | 37,507 |
Balance at September 30, 2019 | $ 99,547 |
GOODWILL AND INTANGIBLE ASSET_4
GOODWILL AND INTANGIBLE ASSETS - Schedule of Intangible Assets (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of acquired intangible assets | $ 1,967,000 | $ 0 | $ 3,736,000 | $ 0 |
Gross Carrying Value | 110,090,000 | 110,090,000 | ||
Accumulated Amortization | (3,736,000) | (3,736,000) | ||
Intangible Assets, Net | 106,354,000 | 106,354,000 | ||
Developed technology | ||||
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Gross Carrying Value | 110,000,000 | 110,000,000 | ||
Accumulated Amortization | (3,732,000) | (3,732,000) | ||
Intangible Assets, Net | 106,268,000 | $ 106,268,000 | ||
Estimated Useful Life | 14 years | |||
Customer relationships | ||||
Acquired Finite-Lived Intangible Assets [Line Items] | ||||
Gross Carrying Value | 90,000 | $ 90,000 | ||
Accumulated Amortization | (4,000) | (4,000) | ||
Intangible Assets, Net | $ 86,000 | $ 86,000 | ||
Estimated Useful Life | 10 years |
DEBT (Details)
DEBT (Details) - Unsecured Debt - Convertible Senior Notes Due 2022 - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Mar. 13, 2017 |
Debt Instrument [Line Items] | |||
Stated interest rate (as a percent) | 2.375% | 2.375% | |
Convertible senior notes, gross | $ 345,000 | $ 345,000 | |
Deferred financing costs | (4,577) | (5,850) | |
Discount on debt | (38,342) | (48,558) | |
Total debt, net of debt discount and deferred financing costs | $ 302,081 | $ 290,592 |
DEBT (Details 2)
DEBT (Details 2) - USD ($) | Feb. 01, 2019 | Mar. 13, 2017 | Sep. 30, 2019 | Mar. 07, 2017 |
DEBT AND FINANCING OBLIGATIONS | ||||
Settlement period - convertible debt conversion request | 40 days | |||
Closing sale price (in dollars per share) | $ 38.07 | |||
Repayments of debt | $ 300,000 | |||
Repayment of Conversion Premium | $ 200,000 | |||
Convertible Senior Notes Due 2022 | ||||
DEBT AND FINANCING OBLIGATIONS | ||||
Initial conversion rate of common stock per $1000 of principal amount of Notes (in shares) | 14.9491 | |||
Initial conversion price of notes into common stock (in dollars per share) | $ 66.89 | |||
Convertible debt, premium on common stock | 37.50% | |||
Closing sale price (in dollars per share) | $ 48.65 | |||
Debt issuance costs, amortization period | 5 years | |||
Convertible Senior Notes Due 2022 | Conversion terms prior to close of business on business day immediately proceeding October 1, 2021 | ||||
DEBT AND FINANCING OBLIGATIONS | ||||
Convertible debt, common stock closing sales price minimum, number of trading days | 20 days | |||
Convertible debt, number of consecutive trading days | 30 days | |||
Convertible debt, common stock closing sales price minimum as percentage of conversion price | 130.00% | |||
Principal amount used for debt instrument conversion ratio | $ 1,000 | |||
Market price per $1000 of principal amount of notes | 987 | |||
Convertible Senior Notes Due 2022 | Debt Redemption Terms on or after April 1, 2020 | ||||
DEBT AND FINANCING OBLIGATIONS | ||||
Convertible debt, common stock closing sales price minimum, number of trading days | 20 days | |||
Convertible debt, number of consecutive trading days | 30 days | |||
Convertible debt, common stock closing sales price minimum as percentage of conversion price | 130.00% | |||
Debt Instrument Conversion Obligation Number of Trading Days Prior to Date on which Entity Provides Notice of Redemption | 5 days | |||
Debt Instrument, Percentage of Principal Amount for Computation of Redemption Price | 100.00% | |||
Convertible Senior Notes Due 2019 | ||||
DEBT AND FINANCING OBLIGATIONS | ||||
Stated interest rate (as a percent) | 3.25% | |||
Principal amount used for debt instrument conversion ratio | $ 1,000 | |||
Unsecured Debt | Convertible Senior Notes Due 2022 | ||||
DEBT AND FINANCING OBLIGATIONS | ||||
Debt issued in private placement | $ 345,000,000 | |||
Stated interest rate (as a percent) | 2.375% | 2.375% |
DEBT (Details 3)
DEBT (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Amortization of debt discount | $ 10,216 | $ 9,512 | ||
Capitalized interest (Note 6) | $ (100) | $ (700) | ||
Effective interest rate on convertible senior notes | 7.81% | 7.81% | 7.81% | 7.81% |
Convertible Senior Notes Due 2019 | ||||
Contractual interest expense | $ 2,048 | $ 2,051 | $ 6,146 | $ 6,153 |
Amortization of debt issuance costs | 429 | 411 | 1,273 | 1,219 |
Amortization of debt discount | 3,467 | 3,228 | 10,216 | 9,512 |
Capitalized interest (Note 6) | (4) | (48) | (4) | (689) |
Total | $ 5,940 | $ 5,642 | $ 17,631 | $ 16,195 |
FINANCIAL INSTRUMENTS (Details)
FINANCIAL INSTRUMENTS (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($)customer | Dec. 31, 2017customer | Dec. 31, 2018USD ($) | |
Concentration Risk [Line Items] | |||||
Investment in convertible preferred B shares | $ 14,100,000 | ||||
Additional cash investments in TELA Bio's convertible preferred B shares | $ 1,600,000 | ||||
Number of major customers | customer | 3 | 3 | |||
Amount of allowance for doubtful accounts | $ 0 | $ 0 | $ 0 | ||
Acquisition-related contingent consideration | 7,000,000 | $ 7,000,000 | |||
Accounts receivable | Credit risk | Major customer one | |||||
Concentration Risk [Line Items] | |||||
Concentration risk (as a percent) | 34.00% | 32.00% | |||
Accounts receivable | Credit risk | Major customer two | |||||
Concentration Risk [Line Items] | |||||
Concentration risk (as a percent) | 30.00% | 32.00% | |||
Accounts receivable | Credit risk | Major customer three | |||||
Concentration Risk [Line Items] | |||||
Concentration risk (as a percent) | 29.00% | 29.00% | |||
Myoscience Acquisition | |||||
Concentration Risk [Line Items] | |||||
Acquisition-related contingent consideration | 35,800,000 | $ 35,800,000 | |||
Change in fair value of the contingent consideration since acqusition | $ 7,300,000 | $ 7,300,000 | |||
Remaining term of the milestone achievement period (in years) | 4 years 3 months |
FINANCIAL INSTRUMENTS (Details
FINANCIAL INSTRUMENTS (Details 1) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Mar. 13, 2017 | Sep. 30, 2019 | Mar. 07, 2017 |
Fair Value Measurements | |||
Acquisition-related contingent consideration | $ 7,000 | ||
Closing sale price (in dollars per share) | $ 38.07 | ||
Convertible Senior Notes Due 2022 | |||
Fair Value Measurements | |||
Closing sale price (in dollars per share) | $ 48.65 | ||
Initial conversion price of notes into common stock (in dollars per share) | $ 66.89 | ||
Convertible Senior Notes Due 2022 | Level 1 | |||
Fair Value Measurements | |||
Convertible senior notes | $ 0 | ||
Convertible Senior Notes Due 2022 | Level 2 | |||
Fair Value Measurements | |||
Convertible senior notes | 340,472 | ||
Convertible Senior Notes Due 2022 | Level 3 | |||
Fair Value Measurements | |||
Convertible senior notes | 0 | ||
Convertible Senior Notes Due 2022 | Carrying Value | |||
Fair Value Measurements | |||
Convertible senior notes | 302,081 | ||
Maximum | Convertible Senior Notes Due 2022 | |||
Fair Value Measurements | |||
Debt Instrument, Convertible, Conversion Premium, Shares | 5.2 | ||
Myoscience Acquisition | |||
Fair Value Measurements | |||
Acquisition-related contingent consideration | 35,800 | ||
Myoscience Acquisition | Level 1 | |||
Fair Value Measurements | |||
Acquisition-related contingent consideration | 0 | ||
Myoscience Acquisition | Level 2 | |||
Fair Value Measurements | |||
Acquisition-related contingent consideration | 0 | ||
Myoscience Acquisition | Level 3 | |||
Fair Value Measurements | |||
Acquisition-related contingent consideration | 35,797 | ||
Myoscience Acquisition | Carrying Value | |||
Fair Value Measurements | |||
Acquisition-related contingent consideration | $ 35,797 | ||
Unsecured Debt | Convertible Senior Notes Due 2022 | |||
Fair Value Measurements | |||
Stated interest rate (as a percent) | 2.375% | 2.375% |
FINANICIAL INSTRUMENTS (Details
FINANICIAL INSTRUMENTS (Details 2) - Myoscience Acquisition | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Projected years of payment for regulatory milestones | 4 years 3 months |
Contingent Consideration | Minimum | Fair Value, Inputs, Level 3 | Measurement Input, Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input, contingent consideration | 0.0529 |
Contingent Consideration | Minimum | Fair Value, Inputs, Level 3 | Measurement Input, Expected Milestone Payment | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input, contingent consideration | 0 |
Contingent Consideration | Maximum | Fair Value, Inputs, Level 3 | Measurement Input, Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input, contingent consideration | 0.0564 |
Contingent Consideration | Maximum | Fair Value, Inputs, Level 3 | Measurement Input, Expected Milestone Payment | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input, contingent consideration | 1 |
FINANCIAL INSTRUMENTS (Detail_2
FINANCIAL INSTRUMENTS (Details 3) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Total Milestone Payments Yet To Be Paid in Connection with MyoScience Acquisition | $ 80,000 | $ 80,000 |
Contingent Consideration | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at December 31, 2018 | 0 | |
New financial liabilities entered into on date of MyoScience Acquisition (April 9, 2019) | 28,470 | |
Fair value adjustments | 7,300 | 7,327 |
Balance at September 30, 2019 | $ 35,797 | $ 35,797 |
FINANCIAL INSTRUMENTS (Detail_3
FINANCIAL INSTRUMENTS (Details 4) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Measurements | |||
Unrealized Gain (Loss) on Investments | $ 5,400 | ||
Realized Investment Gains (Losses) | $ 900 | ||
Level 2 | |||
Fair Value Measurements | |||
Cost | $ 250,635 | $ 277,079 | |
Gross Unrealized Gains | 471 | 5 | |
Gross Unrealized Losses | (24) | (285) | |
Fair Value | 251,082 | 276,799 | |
Short-term Investments | Level 2 | |||
Fair Value Measurements | |||
Cost | 180,105 | 251,197 | |
Gross Unrealized Gains | 400 | 0 | |
Gross Unrealized Losses | 0 | (269) | |
Fair Value | 180,505 | 250,928 | |
Long-Term Investments | Level 2 | |||
Fair Value Measurements | |||
Cost | 70,530 | 25,882 | |
Gross Unrealized Gains | 71 | 5 | |
Gross Unrealized Losses | (24) | (16) | |
Fair Value | 70,577 | 25,871 | |
Long-Term Investments | Asset-backed securities | Level 2 | |||
Fair Value Measurements | |||
Cost | 16,518 | 9,383 | |
Gross Unrealized Gains | 23 | 5 | |
Gross Unrealized Losses | (7) | 0 | |
Fair Value | 16,534 | 9,388 | |
Long-Term Investments | Corporate bonds | Level 2 | |||
Fair Value Measurements | |||
Cost | 54,012 | 16,499 | |
Gross Unrealized Gains | 48 | 0 | |
Gross Unrealized Losses | (17) | (16) | |
Fair Value | 54,043 | 16,483 | |
Short-term Investments | Asset-backed securities | Level 2 | |||
Fair Value Measurements | |||
Cost | 29,044 | 34,873 | |
Gross Unrealized Gains | 60 | 0 | |
Gross Unrealized Losses | 0 | (33) | |
Fair Value | 29,104 | 34,840 | |
Short-term Investments | Commercial paper | Level 2 | |||
Fair Value Measurements | |||
Cost | 34,788 | 45,035 | |
Gross Unrealized Gains | 41 | 0 | |
Gross Unrealized Losses | 0 | (30) | |
Fair Value | 34,829 | 45,005 | |
Short-term Investments | Corporate bonds | Level 2 | |||
Fair Value Measurements | |||
Cost | 116,273 | 171,289 | |
Gross Unrealized Gains | 299 | 0 | |
Gross Unrealized Losses | 0 | (206) | |
Fair Value | $ 116,572 | $ 171,083 |
STOCK PLANS (Details)
STOCK PLANS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-Based Compensation | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 3,000,000 | 3,000,000 | ||
Document Period End Date | Sep. 30, 2019 | |||
Stock-based compensation expense | $ 9,244 | $ 8,108 | $ 24,461 | $ 23,539 |
Compensation expense from stock options, employees | 6,257 | 5,270 | 16,509 | 16,452 |
Compensation expense from stock options, non-employee awards | 161 | 209 | 408 | 449 |
Restricted Stock or Unit Expense | 2,639 | 2,479 | 6,950 | 6,088 |
Compensation expense from employee stock purchase plan | 187 | 150 | 594 | 550 |
Stock-based compensation | 9,244 | 8,108 | $ 24,461 | 23,539 |
Purchase price of common stock, ESPP (as a percent) | 85.00% | |||
Shares issued under employee stock purchase plan (shares) | 35,766 | |||
Cost of goods sold | ||||
Share-Based Compensation | ||||
Stock-based compensation expense | 1,243 | 1,179 | $ 3,490 | 3,431 |
Research and development | ||||
Share-Based Compensation | ||||
Stock-based compensation expense | 1,297 | 1,122 | 3,772 | 2,770 |
Selling, general and administrative | ||||
Share-Based Compensation | ||||
Stock-based compensation expense | $ 6,704 | $ 5,807 | $ 17,199 | $ 17,338 |
STOCK PLANS (Details 2)
STOCK PLANS (Details 2) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Weighted Average Exercise Price | |
Weighted average fair value (in dollars per share) | $ 20.97 |
Employee Stock Option | |
Number of Options | |
Outstanding beginning of period (in shares) | shares | 5,722,818 |
Granted (in shares) | shares | 1,792,978 |
Exercised (in shares) | shares | (251,169) |
Forfeited (in shares) | shares | (258,353) |
Expired (in shares) | shares | (125,316) |
Outstanding end of period (in shares) | shares | 6,880,958 |
Weighted Average Exercise Price | |
Outstanding beginning of period (in dollars per share) | $ 41.69 |
Granted (in dollars per share) | 42.81 |
Exercised (in dollars per share) | 19.88 |
Forfeited (in dollars per share) | 41.51 |
Expired (in dollars per share) | 59.20 |
Outstanding at end of period (in dollars per share) | $ 42.46 |
STOCK PLANS (Details 3)
STOCK PLANS (Details 3) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested at beginning of period (shares) | shares | 577,964 |
Granted (shares) | shares | 303,168 |
Vested (shares) | shares | (190,586) |
Forfeited (shares) | shares | (49,611) |
Unvested at end of period (shares) | shares | 640,935 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Unvested at beginning of period (usd per share) | $ / shares | $ 42.14 |
Granted (usd per share) | $ / shares | 43.57 |
Vested (usd per share) | $ / shares | 45.56 |
Forfeited (usd per share) | $ / shares | 41.04 |
Unvested at end of period (usd per share) | $ / shares | $ 41.88 |
Employee Stock Option | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Risk free interest rate (as a percent) | 2.02% |
Expected volatility (as a percent) | 53.88% |
Expected term of options | 5 years 2 months 19 days |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||
Balance at beginning of period | $ (280) | |
Balance at end of period | 447 | |
Accumulated Net Unrealized Investment Gain (Loss) | ||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||
Balance at beginning of period | (280) | $ (454) |
Other comprehensive loss before reclassifications | 727 | 213 |
Balance at end of period | 447 | (241) |
Reclassification from AOCI, Current Period, Net of Tax, Attributable to Parent | $ 0 | $ 0 |
NET INCOME (LOSS) PER SHARE (De
NET INCOME (LOSS) PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Numerator for basic and diluted loss per share | ||||
Net loss | $ (6,087) | $ (640) | $ (6,128) | $ (8,756) |
Denominator | ||||
Weighted average common shares outstanding (in shares) | 41,645 | 40,995 | 41,423 | 40,833 |
Net loss per share: | ||||
Basic and diluted net income (loss) per common share (in USD per share) | $ (0.15) | $ (0.02) | $ (0.15) | $ (0.21) |
NET INCOME (LOSS) PER SHARE (_2
NET INCOME (LOSS) PER SHARE (Details 2) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
EARNINGS PER SHARE | ||||
Total | 5,742 | 6,635 | 4,993 | 5,952 |
Employee Stock Option | ||||
EARNINGS PER SHARE | ||||
Total | 5,443 | 5,988 | 4,816 | 5,392 |
Restricted Stock Units (RSUs) | ||||
EARNINGS PER SHARE | ||||
Total | 266 | 618 | 154 | 528 |
Employee Stock | ||||
EARNINGS PER SHARE | ||||
Total | 33 | 29 | 23 | 32 |
INCOME TAXES INCOME TAXES (Deta
INCOME TAXES INCOME TAXES (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||||
Domestic | $ (3,234) | $ 1,839 | $ 2,345 | $ (7,382) |
Foreign | (2,582) | (2,541) | (9,552) | (1,366) |
Income (loss) before income taxes | (5,816) | (702) | (7,207) | (8,748) |
Income Tax Expense (Benefit) | 271 | (62) | (1,079) | $ 8 |
Income tax expense (less than) | $ 100 | (100) | ||
Valuation allowance on deferred tax assets | $ 1,800 | $ 1,800 |
ACQUISITION-RELATED CHARGES A_3
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Business Acquisition [Line Items] | |||||
Non-recurring charge related to discontinuation | $ 100 | $ 1,300 | $ 100 | $ 1,500 | |
Myoscience Acquisition | |||||
Business Acquisition [Line Items] | |||||
Acquisition-related costs | 7,600 | 12,100 | |||
Advisory Costs | Myoscience Acquisition | |||||
Business Acquisition [Line Items] | |||||
Acquisition-related costs | 200 | 4,100 | |||
Separation Costs, Asset Write-downs, and Other Restructuring Charges | Myoscience Acquisition | |||||
Business Acquisition [Line Items] | |||||
Acquisition-related costs | 100 | 700 | |||
Accounting Standards Update 2016-02 | |||||
Business Acquisition [Line Items] | |||||
Business Exit Costs | $ (1,500) | ||||
Contingent Consideration | |||||
Business Acquisition [Line Items] | |||||
Fair value adjustments | $ 7,300 | $ 7,327 |
ACQUISITION-RELATED CHARGES A_4
ACQUISITION-RELATED CHARGES AND PRODUCT DISCONTINUATION, NET - DepoCyte Product Discontinuance (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
DepoCyte Discontinuation [Line Items] | |||||
Discontinued Operation, Tax Effect of Gain (Loss) from Disposal of Discontinued Operation | $ 100 | $ 1,300 | $ 100 | $ 1,500 | |
DepoCyte Discontinuation [Roll Forward] | |||||
Acquisition-Related Separation Costs, Beginning Balance | $ 0 | 0 | |||
Acquisition-Related Separation Costs, Charges Incurred | 480 | ||||
Acquisition-Related Separation Costs, Cash Payments Made | (321) | ||||
Acquisition-Related Separation Costs, Ending Balance | 159 | 159 | |||
Acquisition-Related Asset Write-Downs, Charges Incurred | 193 | ||||
Acquisition-Related Asset Write-Downs, Other, Including Non-Cash Activity | (193) | ||||
DepoCyt(e) Lease Costs, Beginning Balance | 1,970 | 1,970 | |||
DepoCyt(e) Lease Costs, Ending Balance | 0 | 0 | |||
Asset Retirement Obligations, Other Restructuring and Discontinuation Costs, Beginning Balance | 282 | 282 | |||
Asset Retirement Obligations, Other Restructuring and Discontinuation Costs, Charges Incurred | 167 | ||||
Asset Retirement Obligations, Other Restructuring and Discontinuation Costs, Cash Payments Made | (307) | ||||
Asset Retirement Obligations, Other Restructuring and Discontinuation Costs, Ending Balance | 597 | 597 | |||
Total, Beginning Balance | 2,252 | 2,252 | |||
Total, Charges Incurred | (7,618) | $ (1,259) | (12,266) | $ (1,511) | |
Total, Cash Payments Made | (628) | ||||
Total, Ending Balance | $ 756 | 756 | |||
DepoCyte | |||||
DepoCyte Discontinuation [Roll Forward] | |||||
Total, Charges Incurred | $ 840 | ||||
Accounting Standards Update 2016-02 | |||||
DepoCyte Discontinuation [Roll Forward] | |||||
Total, Reclassifications | $ (1,500) |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Dec. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2019 | |
Subsequent Event [Line Items] | |||
Acquisition-related contingent consideration | $ 7,000 | $ 7,000 | |
Scenario, Forecast | Achievement of Regulatory Milestone | |||
Subsequent Event [Line Items] | |||
Acquisition-related contingent consideration | 5,000 | 5,000 | |
Scenario, Forecast | Achievement of Development and Commercial Milestones | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Acquisition-related contingent consideration | $ 10,000 | ||
Contingent Consideration [Member] | |||
Subsequent Event [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | $ 7,300 | $ 7,327 | |
Contingent Consideration [Member] | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | $ 9,000 |