Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 27, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36257 | |
Entity Registrant Name | TRAVERE THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-4842691 | |
Entity Address, Address Line One | 3611 Valley Centre Drive | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92130 | |
City Area Code | 888 | |
Local Phone Number | 969-7879 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | TVTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 60,717,176 | |
Entity Central Index Key | 0001438533 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 83,288 | $ 84,772 |
Available-for-sale debt securities, at fair value (amortized cost $439,411, allowance for credit losses of $0 as of June 30, 2021; amortized cost $276,111, allowance for credit losses of $0 as of December 31, 2020) | 439,502 | 276,817 |
Accounts receivable, net | 11,860 | 15,925 |
Inventory, net | 7,409 | 7,608 |
Prepaid expenses and other current assets | 7,339 | 8,143 |
Tax receivable | 400 | 17,142 |
Total current assets | 549,798 | 410,407 |
Property and equipment, net | 11,720 | 9,418 |
Other non-current assets | 34,361 | 33,489 |
Intangible assets, net | 149,951 | 153,189 |
Goodwill | 936 | 936 |
Total assets | 746,766 | 607,439 |
Current liabilities: | ||
Accounts payable | 8,343 | 12,133 |
Accrued expenses | 62,465 | 56,793 |
Other current liabilities | 8,869 | 6,334 |
Business combination-related contingent consideration, current portion | 17,300 | 17,400 |
Total current liabilities | 96,977 | 92,660 |
Convertible debt | 220,861 | 215,339 |
Other non-current liabilities | 43,725 | 40,527 |
Business combination-related contingent consideration, less current portion | 52,900 | 47,700 |
Total liabilities | 414,463 | 396,226 |
Stockholders' Equity: | ||
Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of June 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock $0.0001 par value; 200,000,000 shares authorized; 60,710,876 and 52,248,431 issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 6 | 5 |
Additional paid-in capital | 1,011,692 | 797,985 |
Accumulated deficit | (678,754) | (585,875) |
Accumulated other comprehensive loss | (641) | (902) |
Total stockholders' equity | 332,303 | 211,213 |
Total liabilities and stockholders' equity | $ 746,766 | $ 607,439 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Available-for-sale debt securities, amortized cost | $ 439,411 | $ 276,111 |
Available-for-sale debt securities, allowance for credit losses | $ 0 | $ 0 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock shares authorized (in shares) | 200,000,000 | 100,000,000 |
Common stock shares issued (in shares) | 60,710,876 | 52,248,431 |
Common stock shares outstanding (in shares) | 60,710,876 | 52,248,431 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Net product sales | $ 54,617 | $ 48,430 | $ 102,024 | $ 96,199 |
Operating expenses: | ||||
Cost of goods sold | 1,651 | 1,494 | 3,296 | 2,864 |
Research and development | 51,807 | 30,790 | 99,753 | 61,038 |
Selling, general and administrative | 34,965 | 34,971 | 71,743 | 68,110 |
Change in fair value of contingent consideration | 1,509 | 4,286 | 10,096 | 2,363 |
Total operating expenses | 89,932 | 71,541 | 184,888 | 134,375 |
Operating loss | (35,315) | (23,111) | (82,864) | (38,176) |
Other income (expenses), net: | ||||
Other income (expense), net | 216 | 426 | (877) | 235 |
Interest income | 988 | 1,316 | 1,397 | 3,291 |
Interest expense | (4,852) | (4,634) | (10,173) | (9,521) |
Total other expense, net | (3,648) | (2,892) | (9,653) | (5,995) |
Loss before income taxes | (38,963) | (26,003) | (92,517) | (44,171) |
Income tax (expense) benefit | (49) | (65) | (362) | 18,911 |
Net loss | $ (39,012) | $ (26,068) | $ (92,879) | $ (25,260) |
Basic net loss per common share (in dollars per share) | $ (0.64) | $ (0.58) | $ (1.59) | $ (0.57) |
Diluted net loss per common share (in dollars per share) | $ (0.64) | $ (0.58) | $ (1.59) | $ (0.57) |
Basic weighted average common shares outstanding (in shares) | 60,571,259 | 44,763,843 | 58,431,770 | 43,943,370 |
Diluted weighted average common shares outstanding (in shares) | 60,571,259 | 44,763,843 | 58,431,770 | 43,943,370 |
Comprehensive loss: | ||||
Net loss | $ (39,012) | $ (26,068) | $ (92,879) | $ (25,260) |
Foreign currency translation | (227) | (247) | 875 | (56) |
Unrealized gain (loss) on debt securities | (152) | 3,146 | (614) | 729 |
Comprehensive loss | $ (39,391) | $ (23,169) | $ (92,618) | $ (24,587) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (92,879) | $ (25,260) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 12,694 | 11,507 |
Non-cash interest expense | 759 | 893 |
Amortization of discounts/premiums on investments, net | 660 | 337 |
Amortization of debt discount and issuance costs | 5,522 | 5,147 |
Provision for inventory | 962 | 662 |
Share-based compensation | 14,767 | 11,474 |
ESPP expense | 437 | 390 |
Change in fair value of contingent consideration | 10,096 | 2,363 |
Payments related to change in fair value of contingent consideration | (3,602) | (8,674) |
Other | 1,807 | 274 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 4,056 | 3,979 |
Inventory | (764) | (875) |
Tax receivable | 17,011 | (18,714) |
Other current and non-current operating assets | (1,224) | (2,508) |
Change in lease assets and liabilities, net | 5,492 | 0 |
Accounts payable and accrued expenses | 4,681 | (16,407) |
Other current and non-current operating liabilities | (453) | (196) |
Net cash used in operating activities | (19,978) | (35,608) |
Cash Flows From Investing Activities: | ||
Purchase of fixed assets | (4,598) | (518) |
Cash paid for intangible assets | (8,979) | (8,532) |
Proceeds from the sale/maturity of debt securities | 242,064 | 153,146 |
Purchase of debt securities | (406,000) | (36,743) |
Net cash provided by (used in) investing activities | (177,513) | 107,353 |
Cash Flows From Financing Activities: | ||
Payment of acquisition-related contingent consideration | (1,399) | (6,101) |
Payment of guaranteed minimum royalty | (1,050) | (1,050) |
Proceeds from exercise of stock options | 3,074 | 431 |
Proceeds from issuances under employee stock purchase plan | 1,275 | 1,098 |
Net cash provided by financing activities | 196,056 | 103,022 |
Effect of exchange rate changes on cash | (49) | (33) |
Net change in cash and cash equivalents | (1,484) | 174,734 |
Cash and cash equivalents, beginning of year | 84,772 | 62,436 |
Cash and cash equivalents, end of period | 83,288 | 237,170 |
At-The-Market Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | 4,878 | 0 |
Underwritten Equity Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | $ 189,278 | $ 108,644 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 43,088,921 | ||||
Beginning balance at Dec. 31, 2019 | $ 221,196 | $ 4 | $ 636,910 | $ 726 | $ (416,444) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 11,474 | 11,474 | |||
Issuance of common stock under the equity incentive plan and proceeds from exercise (in shares) | 241,409 | ||||
Issuance of common stock under the equity incentive plan and proceeds from exercise | 431 | 431 | |||
Equity offering (in shares) | 7,475,000 | ||||
Equity offering, net of issuance costs | 108,644 | $ 1 | 108,643 | ||
Unrealized gain (loss) on debt securities | 729 | 729 | |||
Foreign currency translation adjustments | (56) | (56) | |||
ESPP stock purchase and expense (in shares) | 97,544 | ||||
ESPP stock purchase and expense | 1,487 | 1,487 | |||
Net loss | (25,260) | (25,260) | |||
Ending balance (in shares) at Jun. 30, 2020 | 50,902,874 | ||||
Ending balance at Jun. 30, 2020 | 318,645 | $ 5 | 758,945 | 1,399 | (441,704) |
Beginning balance (in shares) at Mar. 31, 2020 | 43,153,215 | ||||
Beginning balance at Mar. 31, 2020 | 225,748 | $ 4 | 642,880 | (1,500) | (415,636) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 5,760 | 5,760 | |||
Issuance of common stock under the equity incentive plan and proceeds from exercise (in shares) | 177,115 | ||||
Issuance of common stock under the equity incentive plan and proceeds from exercise | 371 | 371 | |||
Equity offering (in shares) | 7,475,000 | ||||
Equity offering, net of issuance costs | 108,644 | $ 1 | 108,643 | ||
Unrealized gain (loss) on debt securities | 3,146 | 3,146 | |||
Foreign currency translation adjustments | (247) | (247) | |||
ESPP stock purchase and expense (in shares) | 97,544 | ||||
ESPP stock purchase and expense | 1,291 | 1,291 | |||
Net loss | (26,068) | (26,068) | |||
Ending balance (in shares) at Jun. 30, 2020 | 50,902,874 | ||||
Ending balance at Jun. 30, 2020 | 318,645 | $ 5 | 758,945 | 1,399 | (441,704) |
Beginning balance (in shares) at Dec. 31, 2020 | 52,248,431 | ||||
Beginning balance at Dec. 31, 2020 | 211,213 | $ 5 | 797,985 | (902) | (585,875) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 14,767 | 14,767 | |||
Issuance of common stock under the equity incentive plan and proceeds from exercise (in shares) | 646,872 | ||||
Issuance of common stock under the equity incentive plan and proceeds from exercise | 3,074 | 3,074 | |||
Equity offering (in shares) | 7,716,686 | ||||
Equity offering, net of issuance costs | 194,157 | $ 1 | 194,156 | ||
Unrealized gain (loss) on debt securities | (614) | (614) | |||
Foreign currency translation adjustments | 875 | 875 | |||
ESPP stock purchase and expense (in shares) | 98,887 | ||||
ESPP stock purchase and expense | 1,710 | 1,710 | |||
Net loss | (92,879) | (92,879) | |||
Ending balance (in shares) at Jun. 30, 2021 | 60,710,876 | ||||
Ending balance at Jun. 30, 2021 | 332,303 | $ 6 | 1,011,692 | (641) | (678,754) |
Beginning balance (in shares) at Mar. 31, 2021 | 60,435,730 | ||||
Beginning balance at Mar. 31, 2021 | 362,689 | $ 6 | 1,002,687 | (262) | (639,742) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 7,288 | 7,288 | |||
Issuance of common stock under the equity incentive plan and proceeds from exercise (in shares) | 176,259 | ||||
Issuance of common stock under the equity incentive plan and proceeds from exercise | 319 | 319 | |||
Equity offering, net of issuance costs | (98) | (98) | |||
Unrealized gain (loss) on debt securities | (152) | (152) | |||
Foreign currency translation adjustments | (227) | (227) | |||
ESPP stock purchase and expense (in shares) | 98,887 | ||||
ESPP stock purchase and expense | 1,496 | 1,496 | |||
Net loss | (39,012) | (39,012) | |||
Ending balance (in shares) at Jun. 30, 2021 | 60,710,876 | ||||
Ending balance at Jun. 30, 2021 | $ 332,303 | $ 6 | $ 1,011,692 | $ (641) | $ (678,754) |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | DESCRIPTION OF BUSINESS Organization and Description of Business Travere Therapeutics, Inc. (“we”, “our”, “us”, “Travere” and the “Company”) refers to Travere Therapeutics, Inc., a Delaware corporation, as well as our direct and indirect subsidiaries. Travere is a fully integrated biopharmaceutical company headquartered in San Diego, California focused on identifying, developing and delivering life-changing therapies to people with rare diseases. We regularly evaluate and, where appropriate, act on opportunities to expand our product pipeline through licenses and acquisitions of products in areas that will serve patients with serious or rare diseases and that we believe offer attractive growth characteristics. The ongoing novel coronavirus (COVID-19) pandemic has resulted in travel restrictions, quarantines, “stay-at-home” and “shelter-in-place” orders and extended shutdown of certain businesses around the world. While the impact of the COVID-19 pandemic did not have a material adverse effect on our financial position or results of operations for the six months ended June 30, 2021, these governmental actions and similar actions that may be enacted in the future, and the widespread economic disruption arising from the pandemic, have the potential to materially impact our business and influence our business decisions. The extent and duration of the pandemic is unknown, and the future effects on our business are uncertain and difficult to predict. The Company is continuing to monitor the events and circumstances surrounding the COVID-19 pandemic, which may require adjustments to the Company’s estimates and assumptions in the future. Clinical Programs: Sparsentan , also known as RE-021, is an investigational product candidate with a dual mechanism of action, selective endothelin receptor antagonist (“ERA”), with in vitro selectivity toward endothelin receptor type A, and a potent angiotensin receptor blocker (“ARB”). Sparsentan is currently being evaluated in two pivotal Phase 3 clinical studies in the following indications: • Focal segmental glomerulosclerosis ("FSGS") is a rare kidney disease characterized by proteinuria where the glomeruli become progressively scarred. FSGS is a leading cause of end-stage renal disease. • Immunoglobulin A nephropathy ("IgAN") is an immune-complex-mediated glomerulonephritis characterized by hematuria, proteinuria, and variable rates of progressive renal failure. IgAN is the most common primary glomerular disease. Pegtibatinase (TVT-058) is a novel investigational human enzyme replacement candidate being evaluated for the treatment of classical homocystinuria (HCU). Classical HCU is a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to vision, skeletal, circulatory and central nervous system issues. Pegtibatinase (TVT-058) is currently being tested in a Phase 1/2 double blind, randomized, placebo-controlled dose escalation study to assess its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects in patients with classical HCU. Pegtibatinase (TVT-058) has been granted Rare Pediatric Disease and Fast Track designations by the FDA, as well as orphan drug designation in the United States and Europe. We acquired pegtibatinase (TVT-058) as part of the November 2020 acquisition of Orphan Technologies Limited. Chenodal (chenodeoxycholic acid or CDCA) is a naturally occurring bile acid that is approved for the treatment of people with radiolucent stones in the gallbladder. CTX is a rare, progressive and underdiagnosed bile acid synthesis disorder affecting many parts of the body. In January 2020, we randomized the first patients in our Phase 3 RESTORE Study to evaluate the effects of Chenodal in adult and pediatric patients with CTX, and the study enrollment remains open. The pivotal study is intended to support an NDA submission for marketing authorization of Chenodal for CTX in the United States. Preclinical Programs: The Company is a participant in two Cooperative Research and Development Agreements ("CRADAs"), which form a multi-stakeholder approach to pool resources with leading experts, and incorporate the patient perspective early in the therapeutic identification and development process. We have partnered with the National Institutes of Health’s National Center for Advancing Translational Sciences ("NCATS") and leading patient advocacy organizations, CDG Care and Alagille Syndrome Alliance, aimed at the identification of potential small molecule therapeutics for NGLY1 deficiency and Alagille syndrome, respectively. There are no treatment options currently approved for these diseases. Approved products: • Chenodal (chenodiol tablets) is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. • Cholbam® (cholic acid capsules) is approved in the United States for the treatment of bile acid synthesis disorders due to single enzyme defects and is further indicated for adjunctive treatment of patients with peroxisomal disorders. |
BASIS OF PRESENTATION AND SIGNI
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2020 10-K filed with the SEC on March 1, 2021. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions for Form 10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for annual financial statements, but reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair statement of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of the results that may be expected for any future periods. The December 31, 2020 balance sheet information was derived from the audited financial statements as of that date. A summary of the significant accounting policies applied in the preparation of the accompanying condensed consolidated financial statements follows: Principles of Consolidation The unaudited condensed consolidated financial statements represent the consolidation of the accounts of the Company and its subsidiaries in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect substantially all the consideration it is entitled to in exchange for the goods or services it transfers to the customer. See Note 3 for further discussion. Research and Development Expenses Research and development expenses are comprised of salaries and bonuses, benefits, non-cash share-based compensation, license fees, costs paid to third-party contractors to perform research, conduct clinical trials and pre/non-clinical trials, develop drug materials, and associated overhead expenses and facilities. We also incur indirect costs that are not allocated to specific programs because such costs benefit multiple development programs and allow us to increase our pharmaceutical development capabilities. These consist of internal shared resources related to the development and maintenance of systems and processes applicable to all of our programs. Clinical Trial Expenses Our clinical trials are conducted pursuant to contracts with contract research organizations ("CROs") that support conducting and managing clinical trials. The financial terms and activities of these agreements vary from contract to contract and may result in uneven expense levels. Generally, these agreements set forth activities that drive the recording of expenses such as start-up, initiation activities, enrollment, treatment of patients, or the completion of other clinical trial activities. Expenses related to clinical trials are accrued based on our estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts we are obligated to pay under our clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we adjust our accruals accordingly on a prospective basis. Revisions to our contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. We currently have three Phase 3 clinical trials in process that are in varying stages of activity, with ongoing non-clinical support trials. As such, clinical trial expenses will vary depending on all the factors set forth above and may fluctuate significantly from quarter to quarter. Intangible Assets with Cost Accumulation Model In 2014, the Company entered into a license agreement with Mission Pharmacal in which the Company obtained the exclusive right to license the trademark of Thiola. The acquisition of the Thiola license qualified as an asset acquisition under the principles of ASC 805 in effect at the time of acquisition. The license agreement requires the Company to make royalty payments based on net sales of Thiola. The liability for royalties in excess of the annual contractual minimum is recognized in the period in which the royalties become probable and estimable, which is typically in the period corresponding with the respective sales. The Company records an offsetting increase to the cost basis of the asset under the cost accumulation model. The additional cost basis is subsequently amortized over the remaining life of the license agreement. Consistent with all prior periods since Thiola was acquired, the Company has not accrued any liability for royalties in excess of the annual contractual minimum at June 30, 2021, as such royalties are not yet probable and estimable. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption. In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. The ASU includes amendments to the guidance on convertible instruments and the derivative scope exception for contracts in an entity's own equity and simplifies the accounting for convertible instruments which include beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, the ASU will require entities to use the "if-converted" method when calculating diluted earnings per share for convertible instruments. The ASU is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company's assessment of the impact of the new standard on the Company's financial statements is ongoing. |
REVENUE RECOGNITION
REVENUE RECOGNITION | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE RECOGNITION | REVENUE RECOGNITION Product Revenue, Net Product sales consist of Bile Acid products (Chenodal and Cholbam) and Tiopronin products (Thiola and Thiola EC). The Company sells its products through direct-to-patient distributors worldwide, with more than 99% of the revenue generated in North America. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs upon delivery to the customer. The Company receives payments from its product sales based on terms that generally are within 30 days of delivery of product to the patient. Deductions from Revenue Revenues from product sales are recorded at the net sales price, which includes provisions resulting from discounts, rebates and co-pay assistance that are offered to customers, health care providers, payors and other indirect customers relating to the Company’s sales of its products. These provisions are based on the amounts earned or to be claimed on the related sales and are classified as a reduction of accounts receivable (if the amount is payable to a customer) or as a current liability (if the amount is payable to a party other than a customer). Where appropriate, these reserves take into consideration the Company’s historical experience, current contractual and statutory requirements and specific known market events and trends. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. If actual results in the future vary from the Company’s provisions, the Company will adjust the provision, which would affect net product revenue and earnings in the period such variances become known. Our historical experience is that such adjustments have been immaterial. Government Rebates: We calculate the rebates that we will be obligated to provide to government programs and deduct these estimated amounts from our gross product sales at the time the revenues are recognized. Allowances for government rebates and discounts are established based on actual payer information, which is reasonably estimated at the time of delivery, and the government-mandated discounts applicable to government-funded programs. Rebate discounts are included in other current liabilities in the accompanying consolidated balance sheets. Commercial Rebates: We calculate the rebates that we incur due to contracts with certain commercial payors and deduct these amounts from our gross product sales at the time the revenues are recognized. Allowances for commercial rebates are established based on actual payer information, which is reasonably estimated at the time of delivery. Rebate discounts are included in other current liabilities in the accompanying consolidated balance sheets. Prompt Pay Discounts: We offer discounts to certain customers for prompt payments. We accrue for the calculated prompt pay discount based on the gross amount of each invoice for those customers at the time of sale. Product Returns: Consistent with industry practice, we offer our customers a limited right to return product purchased directly from the Company, which is principally based upon the product’s expiration date. Generally, shipments are only made upon a patient prescription thus returns are minimal. Co-pay Assistance: We offer a co-pay assistance program, which is intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an identification of claims and the cost per claim associated with product that has been recognized as revenue. The following table summarizes net product revenues for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Bile acid products $ 24,974 $ 21,573 $ 46,938 $ 43,854 Tiopronin products 29,643 26,857 55,086 52,345 Total net product revenue $ 54,617 $ 48,430 $ 102,024 $ 96,199 |
DEBT SECURITIES
DEBT SECURITIES | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
DEBT SECURITIES | DEBT SECURITIESThe Company's debt securities as of June 30, 2021 and December 31, 2020 were comprised of available-for-sale corporate and government debt securities. These securities are carried at fair value, with the unrealized gains and losses reported in accumulated other comprehensive income (loss), unless an impairment is determined to be the result of credit-related factors or the Company intends to sell the security or it is more likely than not that the Company will be required to sell the security before recovery. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income. Realized gains and losses and declines in value that are determined to be the result of credit losses, if any, on available-for-sale securities are included in other income or expense. Unrealized losses that are determined to be credit-related are also recorded as an allowance against the amortized cost basis. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. All available-for-sale securities are classified as current assets, even if the maturity when acquired by the Company is greater than one year due to the ability to liquidate within the next 12 months. During the six months ended June 30, 2021, investment activity for the Company included $242.1 million in maturities and $406.0 million in purchases, all relating to debt based marketable securities. Debt securities consisted of the following ( in thousands ): June 30, 2021 December 31, 2020 Commercial paper $ 178,837 $ 135,145 Corporate debt securities 226,351 98,646 Securities of government sponsored entities 34,314 43,026 Total debt securities $ 439,502 $ 276,817 The following is a summary of short-term debt securities classified as available-for-sale as of June 30, 2021 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Commercial paper Less than 1 $ 178,865 $ 3 $ (31) $ 178,837 Corporate debt securities Less than 1 117,411 212 (29) 117,594 Securities of government-sponsored entities Less than 1 31,824 — (5) 31,819 Total maturity less than 1 year 328,100 215 (65) 328,250 Corporate debt securities 1 to 2 108,811 6 (60) 108,757 Securities of government-sponsored entities 1 to 2 2,500 — (5) 2,495 Total maturity 1 to 2 years 111,311 6 (65) 111,252 Total available-for-sale securities $ 439,411 $ 221 $ (130) $ 439,502 The following is a summary of short-term debt securities classified as available-for-sale as of December 31, 2020 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Commercial paper Less than 1 $ 135,161 $ 1 $ (17) $ 135,145 Corporate debt securities Less than 1 92,906 723 — 93,629 Securities of government-sponsored entities Less than 1 43,031 — (5) 43,026 Total maturity less than 1 year 271,098 724 (22) 271,800 Corporate debt securities 1 to 2 5,013 4 — 5,017 Total available-for-sale securities $ 276,111 $ 728 $ (22) $ 276,817 The primary objective of the Company’s investment portfolio is to preserve capital and liquidity while enhancing overall returns. The Company’s investment policy limits interest-bearing security investments to certain types of instruments issued by institutions with primarily investment grade credit ratings and places restrictions on maturities and concentration by asset class and issuer. The Company reviews the available-for-sale debt securities for declines in fair value below the cost basis each quarter. For any security whose fair value is below its amortized cost basis, the Company first evaluates whether it intends to sell the impaired security, or will otherwise be more likely than not required to sell the security before recovery. If either are true, the amortized cost basis of the security is written down to its fair value at the reporting date. If neither circumstance holds true, the Company assesses whether any portion of the unrealized loss is a result of a credit loss. Any amount deemed to be attributable to credit loss is recognized in the income statement, with the amount of the loss limited to the difference between fair value and amortized cost and recorded as an allowance for credit losses. The portion of the unrealized loss related to factors other than credit losses is recognized in other comprehensive income (loss). The following is a summary of available-for-sale debt securities in an unrealized loss position with no credit losses reported as of June 30, 2021 ( in thousands ): Less Than 12 Months 12 Months or Greater Total Description of Securities Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Commercial paper $ 132,356 $ 31 $ — $ — $ 132,356 $ 31 Corporate debt securities 142,673 89 — — 142,673 89 Securities of government-sponsored entities 7,565 10 — — 7,565 10 Total $ 282,594 $ 130 $ — $ — $ 282,594 $ 130 The following is a summary of available-for-sale debt securities in an unrealized loss position with no credit losses reported as of December 31, 2020 ( in thousands ): Less Than 12 Months 12 Months or Greater Total Description of Securities Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Commercial paper $ 112,148 $ 17 $ — $ — $ 112,148 $ 17 Corporate debt securities — — — — — — Securities of government-sponsored entities 43,026 5 — — 43,026 5 Total $ 155,174 $ 22 $ — $ — $ 155,174 $ 22 As of June 30, 2021 and December 31, 2020, the Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis. The Company does not believe the unrealized losses incurred during the period are due to credit-related factors. Liquidity issues that arose from economic circumstances surrounding the COVID-19 pandemic have continued to ease and unrealized losses observed in early 2020 have been substantially recovered. The credit ratings of the securities held remain of the highest quality, and while certain securities in the portfolio may be downgraded momentarily, the Federal Reserve has allowed institutions to continue to issue debt where there is need, with the government itself purchasing such securities. Moreover, the Company continues to receive payments of interest and principal as they become due, and our expectation is that those payments will continue to be received timely. Uncertainty surrounding the COVID-19 pandemic, as well as other factors unknown to us at this time, may cause actual results to differ and require adjustments to the Company’s estimates and assumptions in the future. |
ACQUISITIONS AND DISPOSITIONS
ACQUISITIONS AND DISPOSITIONS | 6 Months Ended |
Jun. 30, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
ACQUISITIONS AND DISPOSITIONS | ACQUISITIONS AND DISPOSITIONS Acquisition of Orphan Technologies Limited In November 2020, the Company completed the acquisition of Orphan Technologies Limited (“Orphan”), including Orphan’s rare metabolic disorder drug OT-58, renamed pegtibatinase (TVT-058). The Company acquired Orphan by purchasing all of its outstanding shares. In exchange for the shares, the Company made an upfront cash payment at closing of $90.0 million plus closing adjustments, net liabilities assumed, and transaction expenses of $1.2 million, $1.8 million, and $4.2 million, respectively. Under the Agreement, the Company has also agreed to make contingent cash payments up to an aggregate of $427.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Agreement, as well as additional tiered mid-single digit royalty payments based upon future net sales of any pegtibatinase (TVT-058) products in the US and Europe, subject to certain reductions as set forth in the Agreement, and a contingent payment in the event a pediatric rare disease voucher for any pegtibatinase (TVT-058) product is granted. The Company has applied the principles of ASC 805 in determining the proper accounting treatment for the acquisition. Substantially all of the value of the assets acquired is concentrated within pegtibatinase (TVT-058), and as of the acquisition date, the Company does not anticipate any economic benefit to be derived from pegtibatinase (TVT-058) other than the primary indication. Accordingly, the transaction is treated as an asset acquisition with amounts charged to expense for the acquired in-process research and development on the date of acquisition. In accordance with ASC 450, contingent cash payments will be accrued for when it is probable that a liability has been incurred and the amount can be reasonably estimated. As of June 30, 2021, no contingent cash payments have been accrued. |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
LEASES | LEASES As of June 30, 2021, the Company had one operating lease with Kilroy Realty, L.P. (the "Landlord") for office space located in San Diego, California, which was entered into in April 2019 and subsequently amended in May 2020. Coinciding with our ability to direct the use of the office space, which occurred in phases over 2020, and utilizing a discount rate equal to our borrowing rate, the Company established ROU assets totaling $34.6 million and lease liabilities totaling $34.5 million. The total ROU asset and lease liability at measurement were each offset by lease incentives associated with tenant improvement allowances totaling $7.9 million. The initial term of the office lease ends in August 2028, and the Landlord has granted the Company an option to extend the term of the lease by a period of 5 years. At this time, it is not reasonably certain that we will extend the term of the lease and therefore the renewal period has been excluded from the aforementioned ROU asset and lease liability measurements. The measurement of the lease term occurs from the February 2021 occupancy date of the office space delivered in September 2020. The aggregate base rent due over the initial term of the lease is approximately $49.5 million. Following is a schedule of the future minimum rental commitments for our operating leases reconciled to the lease liability and ROU asset as of June 30, 2021 ( in thousands ): June 30, 2021 2021 $ 1,842 2022 6,020 2023 6,200 2024 6,386 2025 6,578 Thereafter 18,535 Total undiscounted future minimum payments 45,561 Lease incentives payable by lessor (566) Present value discount (9,456) Total lease liability 35,539 Unamortized lease incentives, less incentives payable by lessor (6,485) Cash payments in excess of straight-line lease expense (4,638) Total ROU asset $ 24,416 As of June 30, 2021, the ROU asset of $24.4 million was recorded to the Condensed Consolidated Balance Sheets as non-current Other Assets . As of June 30, 2021, the current and non-current portions of the lease liability were recorded to the Condensed Consolidated Balance Sheets as follows ( in thousands ): June 30, 2021 Other current liabilities $ 2,623 Other non-current liabilities 32,916 Total lease liabilities $ 35,539 For the three and six months ended June 30, 2021, the Company recorded $1.2 million and $2.4 million in expense related to operating leases, including amortized tenant improvement allowances. For the three and six months ended June 30, 2020, the Company recorded a credit to expense of $0.2 million and zero in expense related to operating leases, including amortized tenant improvement allowances. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS Financial Instruments and Fair Value The Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. The valuation techniques used to measure the fair value of the Company’s debt securities and all other financial instruments, all of which have counter-parties with high credit ratings, were valued based on quoted market prices or model driven valuations using significant inputs derived from or corroborated by observable market data. Based on the fair value hierarchy, the Company classified debt securities within Level 2. The Company acquired two businesses, related to the Cholbam and Chenodal products, whose purchase price included potential future payments that are contingent on the achievement of certain milestones and percentages of future net sales derived from the products acquired. The Company recorded contingent consideration liabilities at their fair value on the acquisition date and revalues them at the end of each reporting period. In estimating the fair value of the Company’s contingent consideration, the Company uses a Monte Carlo Simulation. The determination of the contingent consideration liabilities requires significant judgements including the appropriateness of the valuation model and reasonableness of estimates and assumptions included in the forecasts of future net sales and the discount rates applied to such forecasts. Changes in these estimates and assumptions could have a significant impact on the fair value of the contingent consideration liabilities. Discount rates used to determine the fair value at June 30, 2021 and December 31, 2020 are as follows: Revenue Discount Payment Discount Cholbam Chenodal June 30, 2021 6.5% 7.5% 7.85% December 31, 2020 6.5% 8.5% 7.45% Based on the fair value hierarchy, the Company classified the fair value measurement of contingent consideration within Level 3 because valuation inputs are based on projected revenues discounted to a present value. Financial instruments with carrying values approximating fair value include cash and cash equivalents, accounts receivable, and accounts payable, due to their short-term nature. As of June 30, 2021, the fair value of the Company's 2.5% Convertible Senior Notes due 2025 was $234.7 million, which was estimated utilizing market quotations, and are considered Level 2. The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of June 30, 2021 ( in thousands ): As of June 30, 2021 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash and Cash Equivalents $ 83,288 $ 83,288 $ — $ — Debt securities, available-for-sale 439,502 — 439,502 — Total $ 522,790 $ 83,288 $ 439,502 $ — Liabilities: Business combination-related contingent consideration $ 70,200 $ — $ — $ 70,200 Total $ 70,200 $ — $ — $ 70,200 The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of December 31, 2020 ( in thousands ): As of December 31, 2020 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash and Cash Equivalents $ 84,772 $ 84,772 $ — $ — Debt securities, available-for-sale 276,817 — 276,817 — Total $ 361,589 $ 84,772 $ 276,817 $ — Liabilities: Business combination-related contingent consideration 65,100 — — 65,100 Total $ 65,100 $ — $ — $ 65,100 The following table sets forth a summary of changes in the estimated fair value of the Company's Level 3 business combination-related contingent consideration for the six months ended June 30, 2021 ( in thousands ): Fair Value Measurements of Acquisition-Related Contingent Consideration Balance at January 1, 2021 $ 65,100 Changes in the fair value of contingent consideration 10,096 Contractual payments (2,276) Contractual payments included in accrued liabilities at June 30, 2021 (2,606) Foreign currency impact (114) Balance at June 30, 2021 $ 70,200 For the three and six months ended June 30, 2021, the Company incurred charges of $1.5 million and $10.1 million in operating expenses on the Condensed Consolidated Statements of Operations and Comprehensive Loss for the change in fair value of the contingent consideration liabilities. For the three and six months ended June 30, 2021, the change in fair value of contingent consideration is due to the timing of future payments and changes in market driven discount rates. For the three and six months ended June 30, 2020, the Company incurred charges of $4.3 million and $2.4 million in operating expenses on the Condensed Consolidated Statements of Operations and Comprehensive Loss for the change in fair value of the contingent consideration liabilities. The value changed due to the timing of future payments and changes in market driven discount rates. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | INTANGIBLE ASSETS As of June 30, 2021, the net book value of amortizable intangible assets was approximately $150.0 million. The following table sets forth amortizable intangible assets as of June 30, 2021 and December 31, 2020 ( in thousands ): June 30, 2021 December 31, 2020 Finite-lived intangible assets $ 273,332 $ 264,676 Less: accumulated amortization (123,381) (111,487) Net carrying value $ 149,951 $ 153,189 The following table summarizes amortization expense for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 288 $ 289 $ 574 $ 578 Selling, general and administrative 5,848 4,996 11,514 9,881 Total amortization expense $ 6,136 $ 5,285 $ 12,088 $ 10,459 |
CONVERTIBLE NOTES PAYABLE
CONVERTIBLE NOTES PAYABLE | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE NOTES PAYABLE | CONVERTIBLE NOTES PAYABLE Convertible Senior Notes Due 2025 On September 10, 2018, the Company completed its registered underwritten public offering of $276.0 million aggregate principal amount of 2.50% Convertible Senior Notes due 2025 ("2025 Notes"), and entered into a base indenture and supplemental indenture agreement ("2025 Indenture") with respect to the 2025 Notes. The 2025 Notes will mature on September 15, 2025 ("Maturity Date”), unless earlier repurchased, redeemed, or converted. The 2025 Notes are senior unsecured obligations of the Company and bear interest at an annual rate of 2.50%, payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2019. The composition of the Company’s 2025 Notes are as follows ( in thousands ): June 30, 2021 December 31, 2020 2.50% convertible senior notes due 2025 $ 276,000 $ 276,000 Unamortized debt discount (51,314) (56,384) Unamortized debt issuance costs (3,825) (4,277) Total 2025 Notes, net of unamortized debt discount and debt issuance costs $ 220,861 $ 215,339 The net proceeds from the issuance of the 2025 Notes were approximately $267.2 million, after deducting commissions and the offering expenses payable by the Company. A portion of the net proceeds from the 2025 Notes was used by the Company to repurchase $23.4 million aggregate principal amount of its then-outstanding 4.5% senior convertible notes due 2019 in privately-negotiated transactions. Holders may convert their 2025 Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2018 (and only during such calendar quarter), if the last reported sale price per share of the Company’s common stock for each of at least 20 trading days, whether or not consecutive, during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter exceeds 130% of the conversion price on the applicable trading day; (2) during the five consecutive business days immediately after any 10 consecutive trading day period (“measurement period”) if the trading price per $1,000 principal amount of 2025 Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on the Company’s common stock; (4) if the Company calls the 2025 Notes for redemption; and (5) at any time from, and including, May 15, 2025 until the close of business on the scheduled trading day immediately before the Maturity Date. The Company will settle conversions by paying or delivering, as applicable, 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 election, based on the applicable conversion rate. The initial conversion rate for the 2025 Notes is 25.7739 shares of the Company’s common stock per $1,000 principal amount of 2025 Notes, which represents an initial conversion price of approximately $38.80 per share. If a “make-whole fundamental change” (as defined in the 2025 Indenture) occurs, then the Company will, in certain circumstances, increase the conversion rate for a specified period of time. The 2025 Notes will be redeemable, in whole or in part, at the Company’s option at any time, and from time to time, on or after September 15, 2022 and, in the case of any partial redemption, on or before the 40th scheduled trading day before the Maturity Date, at a cash redemption price equal to the principal amount of the 2025 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice. If a fundamental change (as defined in the 2025 Indenture) occurs, then, subject to certain exceptions, holders may require the Company to repurchase their 2025 Notes at a cash repurchase price equal to the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. As of June 30, 2021, the 2025 Notes had a market price of $851 per $1,000 or $234.7 million principal amount. In the event of conversion, holders would forgo all future interest payments, any unpaid accrued interest and the possibility of further stock price appreciation. Upon the receipt of conversion requests, the settlement of the 2025 Notes will be paid pursuant to the terms of the 2025 Indenture. In the event that all of the 2025 Notes are converted, the Company would be required to repay the $276.0 million principal amount and any conversion premium in any combination of cash and shares of its common stock at the Company’s option. In addition, calling the 2025 Notes for redemption will constitute a “make-whole fundamental change." The 2025 Notes are the Company’s general unsecured obligations that rank senior in right of payment to all of its indebtedness that is expressly subordinated in right of payment to the 2025 Notes, and equal in right of payment to the Company’s unsecured indebtedness. The 2025 Notes are classified on the Company’s Condensed Consolidated Balance Sheets at June 30, 2021 as long-term convertible debt. Under ASC 470-20, Debt with Conversion and Other Options, an entity must separately account for the liability and equity components of convertible debt instruments (such as the 2025 Notes) that may be settled entirely or partially in cash upon conversion, in a manner that reflects the issuer’s economic interest cost. The liability component of the instrument is valued in a manner that reflects the market interest rate for a similar nonconvertible instrument at the date of issuance. The initial carrying value of the liability component was $198.6 million. The equity component of $77.4 million, representing the conversion option, was determined by deducting the fair value of the liability component from the par value of the 2025 Notes and was recorded in additional paid-in capital on the consolidated balance sheet at the issuance date. That equity component is treated as a discount on the liability component of the 2025 Notes, which is amortized over the seven-year term of the 2025 Notes using the effective interest rate method. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company allocated the total transaction costs of approximately $8.8 million related to the issuance of the 2025 Notes to the liability and equity components of the 2025 Notes based on their relative values. Transaction costs attributable to the liability component are amortized to interest expense over the seven-year term of the 2025 Notes, and transaction costs attributable to the equity component are netted with the equity component in stockholders’ equity. The effective interest rate on the liability components of the 2025 Notes for the period from the date of issuance through June 30, 2021 was 7.7%. The following table sets forth total interest expense recognized related to the 2025 Notes ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Contractual interest expense $ 1,725 $ 1,725 $ 3,450 $ 3,450 Amortization of debt discount 2,560 2,371 5,071 4,698 Amortization of debt issuance costs 226 225 451 449 Total interest expense for the 2025 Notes $ 4,511 $ 4,321 $ 8,972 $ 8,597 The 2025 Notes do not contain any financial or operating covenants or any restrictions on the payment of dividends, the issuance of other indebtedness or the issuance or repurchase of securities by the Company. The 2025 Indenture contains customary events of default with respect to the 2025 Notes, including that upon certain events of default, 100% of the principal and accrued and unpaid interest on the 2025 Notes will automatically become due and payable. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses at June 30, 2021 and December 31, 2020 consisted of the following ( in thousands ): June 30, 2021 December 31, 2020 Government rebates payable $ 11,756 $ 10,707 Compensation related costs 12,656 17,912 Accrued royalties and contingent consideration 8,340 7,857 Research and development 21,534 10,166 Selling, general and administrative 4,541 3,944 Miscellaneous accrued 3,638 6,207 Total accrued expenses $ 62,465 $ 56,793 |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
NET LOSS PER COMMON SHARE | NET LOSS PER COMMON SHARE Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding stock options, restricted stock units, and shares issuable upon conversion of the 2025 Notes, are considered to be common stock equivalents and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive. Basic and diluted net loss per share is calculated as follows (net loss amounts are stated in thousands) : Three Months Ended June 30, 2021 2020 Shares Net Loss Loss per common share Shares Net Loss Loss per common share Basic and diluted loss per share 60,571,259 $ (39,012) $ (0.64) 44,763,843 $ (26,068) $ (0.58) Six Months Ended June 30, 2021 2020 Shares Net Loss Loss per common share Shares Net Loss Loss per common share Basic and diluted loss per share 58,431,770 $ (92,879) $ (1.59) 43,943,370 $ (25,260) $ (0.57) The following common stock equivalents have been excluded because they were anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Restricted stock 1,591,426 1,517,338 1,614,123 1,437,383 Convertible debt 7,113,402 7,113,402 7,113,402 7,113,402 Options 9,367,565 8,479,710 9,298,480 8,327,753 Total anti-dilutive shares 18,072,393 17,110,450 18,026,005 16,878,538 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Research Collaboration and Licensing Agreements As part of the Company's research and development efforts, the Company enters into research collaboration and licensing agreements with unrelated companies, scientific collaborators, universities, and consultants. These agreements contain varying terms and provisions which include fees and milestones to be paid by the Company, services to be provided, and ownership rights to certain proprietary technology developed under the agreements. Some of these agreements contain provisions which require the Company to pay royalties, in the event the Company sells or licenses any proprietary products developed under the respective agreements. Legal Proceedings From time to time in the normal course of business, the Company is subject to various legal matters such as threatened or pending claims or litigation. Although the results of claims and litigation cannot be predicted with certainty, the Company does not believe it is a party to any claim or litigation the outcome of which, if determined adversely to it, would individually or in the aggregate be reasonably expected to have a material adverse effect on its results of operations or financial condition. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION Restricted Stock Units Service Based Restricted Stock Units The following table summarizes the Company’s service based restricted stock unit activity during the six months ended June 30, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2020 1,109,942 $ 17.84 Granted 800,797 25.49 Vested (365,492) 17.96 Forfeited/canceled (77,784) 21.42 Unvested June 30, 2021 1,467,463 $ 21.80 At June 30, 2021, unamortized stock compensation for service based restricted stock units was $28.0 million, with a weighted-average recognition period of 2.8 years. Performance Based Restricted Stock Units The following table summarizes the Company’s performance based restricted stock unit activity during the six months ended June 30, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2020 167,500 $ 16.48 Granted — — Vested (75,000) 15.46 Forfeited/canceled — — Unvested June 30, 2021 92,500 $ 17.31 At June 30, 2021, unamortized stock compensation for performance based restricted stock units was less than $0.1 million, with a weighted-average recognition period of 0.7 years. Stock Options The following table summarizes stock option activity during the six months ended June 30, 2021: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 8,242,996 $18.97 6.43 $ 71,641 Granted 1,518,307 26.36 Exercised (206,380) 14.90 Forfeited/canceled (225,803) 22.98 Outstanding at June 30, 2021 9,329,120 $20.17 6.42 $ 4,922 At June 30, 2021, unamortized stock compensation for stock options was $37.2 million, with a weighted-average recognition period of 2.7 years. At June 30, 2021, outstanding options to purchase 6.2 million shares of common stock were exercisable with a weighted-average exercise price per share of $19.23. Share-Based Compensation The following table sets forth total share-based compensation for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 2,845 $ 2,332 $ 5,847 $ 4,458 Selling, general & administrative 4,665 3,622 9,357 7,406 Total $ 7,510 $ 5,954 $ 15,204 $ 11,864 |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXESFor the six months ended June 30, 2021, we recognized an income tax expense of $0.4 million as compared to an income tax benefit of $18.9 million for the six months ended June 30, 2020. The change is primarily related to provisions of the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") concerning net operating loss carrybacks which were effected in 2020. |
INVENTORY
INVENTORY | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory, net of reserves, consisted of the following at June 30, 2021 and December 31, 2020 ( in thousands ): June 30, 2021 December 31, 2020 Raw materials $ 4,099 $ 3,219 Finished goods 3,310 4,389 Total inventory $ 7,409 $ 7,608 The inventory reserve was $3.5 million and $3.6 million at June 30, 2021 and December 31, 2020, respectively. |
ACCOUNTS RECEIVABLE
ACCOUNTS RECEIVABLE | 6 Months Ended |
Jun. 30, 2021 | |
Receivables [Abstract] | |
ACCOUNTS RECEIVABLE | ACCOUNTS RECEIVABLEAccounts receivable, net of reserves for prompt pay discounts and expected credit losses, was $11.9 million and $15.9 million at June 30, 2021 and December 31, 2020, respectively. The total reserves for both periods were immaterial.The Company's evaluation and application of ASU No. 2016-13, Financial Instruments - Credit Losses for the current period included an assessment of our aged trade receivables balances and their underlying credit risk characteristics. Our evaluation of past events, current conditions, and reasonable and supportable forecasts about the future resulted in an expectation of immaterial credit losses. |
EQUITY OFFERINGS
EQUITY OFFERINGS | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
EQUITY OFFERINGS | EQUITY OFFERINGS Underwritten Public Offering of Common Stock In June 2020, the Company sold an aggregate of 7.5 million shares of its common stock in an underwritten public offering, at a price of $15.50 per share. The net proceeds to the Company from the offering, after deducting the underwriting discounts and offering expenses, were $108.7 million. In February 2021, the Company sold an aggregate of 7.5 million shares of its common stock in an underwritten public offering, at a price of $26.75 per share. The net proceeds to the Company from the offering, after deducting the underwriting discounts and offering expenses, were $189.3 million. At-the-Market Equity Offering In February 2020, the Company entered into an Open Market Sale Agreement ("ATM Agreement") with Jefferies LLC, as agent (“Jefferies”), pursuant to which the Company may offer and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $100.0 million. Shares will be sold pursuant to the Company's effective registration statement on Form S-3 (Registration Statement No. 333-227182), as previously filed with the Securities and Exchange Commission. Through June 30, 2021, the Company has sold a total of 1,051,992 shares under the ATM Agreement, resulting in net proceeds of $28.6 million. $4.9 million of this total relates to the settlement of 184,186 shares in the first quarter of 2021. As of June 30, 2021, an aggregate of $71.4 million remained eligible for sale under the facility. Authorized Shares of Common Stock On May 14, 2021, in connection with the Company’s 2021 Annual Meeting of Stockholders, the Company’s stockholders approved, among other matters, a Certificate of Amendment (“Certificate of Amendment”) to the Company’s Certificate of Incorporation to increase the number of shares of common stock authorized for issuance thereunder from 100,000,000 to 200,000,000. Effective May 18, 2021, the Certificate of Amendment was filed with the Secretary of State of the State of Delaware. |
BASIS OF PRESENTATION AND SIG_2
BASIS OF PRESENTATION AND SIGNIFICANT ACCCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements represent the consolidation of the accounts of the Company and its subsidiaries in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation. |
Revenue Recognition | Revenue RecognitionThe Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect substantially all the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Deductions from Revenue Revenues from product sales are recorded at the net sales price, which includes provisions resulting from discounts, rebates and co-pay assistance that are offered to customers, health care providers, payors and other indirect customers relating to the Company’s sales of its products. These provisions are based on the amounts earned or to be claimed on the related sales and are classified as a reduction of accounts receivable (if the amount is payable to a customer) or as a current liability (if the amount is payable to a party other than a customer). Where appropriate, these reserves take into consideration the Company’s historical experience, current contractual and statutory requirements and specific known market events and trends. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. If actual results in the future vary from the Company’s provisions, the Company will adjust the provision, which would affect net product revenue and earnings in the period such variances become known. Our historical experience is that such adjustments have been immaterial. Government Rebates: We calculate the rebates that we will be obligated to provide to government programs and deduct these estimated amounts from our gross product sales at the time the revenues are recognized. Allowances for government rebates and discounts are established based on actual payer information, which is reasonably estimated at the time of delivery, and the government-mandated discounts applicable to government-funded programs. Rebate discounts are included in other current liabilities in the accompanying consolidated balance sheets. Commercial Rebates: We calculate the rebates that we incur due to contracts with certain commercial payors and deduct these amounts from our gross product sales at the time the revenues are recognized. Allowances for commercial rebates are established based on actual payer information, which is reasonably estimated at the time of delivery. Rebate discounts are included in other current liabilities in the accompanying consolidated balance sheets. Prompt Pay Discounts: We offer discounts to certain customers for prompt payments. We accrue for the calculated prompt pay discount based on the gross amount of each invoice for those customers at the time of sale. Product Returns: Consistent with industry practice, we offer our customers a limited right to return product purchased directly from the Company, which is principally based upon the product’s expiration date. Generally, shipments are only made upon a patient prescription thus returns are minimal. Co-pay Assistance: We offer a co-pay assistance program, which is intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an identification of claims and the cost per claim associated with product that has been recognized as revenue. |
Research and Development Expense | Research and Development Expenses Research and development expenses are comprised of salaries and bonuses, benefits, non-cash share-based compensation, license fees, costs paid to third-party contractors to perform research, conduct clinical trials and pre/non-clinical trials, develop drug materials, and associated overhead expenses and facilities. We also incur indirect costs that are not allocated to specific programs because such costs benefit multiple development programs and allow us to increase our pharmaceutical development capabilities. These consist of internal shared resources related to the development and maintenance of systems and processes applicable to all of our programs. |
Clinical Trial Expenses | Clinical Trial Expenses Our clinical trials are conducted pursuant to contracts with contract research organizations ("CROs") that support conducting and managing clinical trials. The financial terms and activities of these agreements vary from contract to contract and may result in uneven expense levels. Generally, these agreements set forth activities that drive the recording of expenses such as start-up, initiation activities, enrollment, treatment of patients, or the completion of other clinical trial activities. Expenses related to clinical trials are accrued based on our estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts we are obligated to pay under our clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we adjust our accruals accordingly on a prospective basis. Revisions to our contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. We currently have three Phase 3 clinical trials in process that are in varying stages of activity, with ongoing non-clinical support trials. As such, clinical trial expenses will vary depending on all the factors set forth above and may fluctuate significantly from quarter to quarter. |
Intangible Assets with Cost Accumulation Model | Intangible Assets with Cost Accumulation Model In 2014, the Company entered into a license agreement with Mission Pharmacal in which the Company obtained the exclusive right to license the trademark of Thiola. The acquisition of the Thiola license qualified as an asset acquisition under the principles of ASC 805 in effect at the time of acquisition. The license agreement requires the Company to make royalty payments based on net sales of Thiola. The liability for royalties in excess of the annual contractual minimum is recognized in the period in which the royalties become probable and estimable, which is typically in the period corresponding with the respective sales. The Company records an offsetting increase to the cost basis of the asset under the cost accumulation model. The additional cost basis is subsequently amortized over the remaining life of the license agreement. Consistent with all prior periods since Thiola was acquired, the Company has not accrued any liability for royalties in excess of the annual contractual minimum at June 30, 2021, as such royalties are not yet probable and estimable. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption. In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. The ASU includes amendments to the guidance on convertible instruments and the derivative scope exception for contracts in an entity's own equity and simplifies the accounting for convertible instruments which include beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, the ASU will require entities to use the "if-converted" method when calculating diluted earnings per share for convertible instruments. The ASU is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company's assessment of the impact of the new standard on the Company's financial statements is ongoing. |
Marketable Securities | The primary objective of the Company’s investment portfolio is to preserve capital and liquidity while enhancing overall returns. The Company’s investment policy limits interest-bearing security investments to certain types of instruments issued by institutions with primarily investment grade credit ratings and places restrictions on maturities and concentration by asset class and issuer. |
Fair Value Measurement | Financial Instruments and Fair Value The Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. |
Income (Loss) Per Share | Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding stock options, restricted stock units, and shares issuable upon conversion of the 2025 Notes, are considered to be common stock equivalents and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive. |
REVENUE RECOGNITION (Tables)
REVENUE RECOGNITION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Summary of net product revenue | The following table summarizes net product revenues for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Bile acid products $ 24,974 $ 21,573 $ 46,938 $ 43,854 Tiopronin products 29,643 26,857 55,086 52,345 Total net product revenue $ 54,617 $ 48,430 $ 102,024 $ 96,199 |
DEBT SECURITIES (Tables)
DEBT SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities | Debt securities consisted of the following ( in thousands ): June 30, 2021 December 31, 2020 Commercial paper $ 178,837 $ 135,145 Corporate debt securities 226,351 98,646 Securities of government sponsored entities 34,314 43,026 Total debt securities $ 439,502 $ 276,817 |
Debt securities available for sale | The following is a summary of short-term debt securities classified as available-for-sale as of June 30, 2021 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Commercial paper Less than 1 $ 178,865 $ 3 $ (31) $ 178,837 Corporate debt securities Less than 1 117,411 212 (29) 117,594 Securities of government-sponsored entities Less than 1 31,824 — (5) 31,819 Total maturity less than 1 year 328,100 215 (65) 328,250 Corporate debt securities 1 to 2 108,811 6 (60) 108,757 Securities of government-sponsored entities 1 to 2 2,500 — (5) 2,495 Total maturity 1 to 2 years 111,311 6 (65) 111,252 Total available-for-sale securities $ 439,411 $ 221 $ (130) $ 439,502 The following is a summary of short-term debt securities classified as available-for-sale as of December 31, 2020 ( in thousands ): Remaining Contractual Maturity Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value Commercial paper Less than 1 $ 135,161 $ 1 $ (17) $ 135,145 Corporate debt securities Less than 1 92,906 723 — 93,629 Securities of government-sponsored entities Less than 1 43,031 — (5) 43,026 Total maturity less than 1 year 271,098 724 (22) 271,800 Corporate debt securities 1 to 2 5,013 4 — 5,017 Total available-for-sale securities $ 276,111 $ 728 $ (22) $ 276,817 |
Schedule of securities in an unrealized loss position | The following is a summary of available-for-sale debt securities in an unrealized loss position with no credit losses reported as of June 30, 2021 ( in thousands ): Less Than 12 Months 12 Months or Greater Total Description of Securities Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Commercial paper $ 132,356 $ 31 $ — $ — $ 132,356 $ 31 Corporate debt securities 142,673 89 — — 142,673 89 Securities of government-sponsored entities 7,565 10 — — 7,565 10 Total $ 282,594 $ 130 $ — $ — $ 282,594 $ 130 The following is a summary of available-for-sale debt securities in an unrealized loss position with no credit losses reported as of December 31, 2020 ( in thousands ): Less Than 12 Months 12 Months or Greater Total Description of Securities Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Commercial paper $ 112,148 $ 17 $ — $ — $ 112,148 $ 17 Corporate debt securities — — — — — — Securities of government-sponsored entities 43,026 5 — — 43,026 5 Total $ 155,174 $ 22 $ — $ — $ 155,174 $ 22 |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Schedule of future minimum rent commitments | Following is a schedule of the future minimum rental commitments for our operating leases reconciled to the lease liability and ROU asset as of June 30, 2021 ( in thousands ): June 30, 2021 2021 $ 1,842 2022 6,020 2023 6,200 2024 6,386 2025 6,578 Thereafter 18,535 Total undiscounted future minimum payments 45,561 Lease incentives payable by lessor (566) Present value discount (9,456) Total lease liability 35,539 Unamortized lease incentives, less incentives payable by lessor (6,485) Cash payments in excess of straight-line lease expense (4,638) Total ROU asset $ 24,416 |
Supplemental balance sheet information | As of June 30, 2021, the current and non-current portions of the lease liability were recorded to the Condensed Consolidated Balance Sheets as follows ( in thousands ): June 30, 2021 Other current liabilities $ 2,623 Other non-current liabilities 32,916 Total lease liabilities $ 35,539 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of discount rates used in valuation | Discount rates used to determine the fair value at June 30, 2021 and December 31, 2020 are as follows: Revenue Discount Payment Discount Cholbam Chenodal June 30, 2021 6.5% 7.5% 7.85% December 31, 2020 6.5% 8.5% 7.45% |
Schedule of fair value on a recurring basis | The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of June 30, 2021 ( in thousands ): As of June 30, 2021 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash and Cash Equivalents $ 83,288 $ 83,288 $ — $ — Debt securities, available-for-sale 439,502 — 439,502 — Total $ 522,790 $ 83,288 $ 439,502 $ — Liabilities: Business combination-related contingent consideration $ 70,200 $ — $ — $ 70,200 Total $ 70,200 $ — $ — $ 70,200 The following table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under the appropriate level of the fair value hierarchy as of December 31, 2020 ( in thousands ): As of December 31, 2020 Total carrying and estimated fair value Quoted prices in active markets Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets: Cash and Cash Equivalents $ 84,772 $ 84,772 $ — $ — Debt securities, available-for-sale 276,817 — 276,817 — Total $ 361,589 $ 84,772 $ 276,817 $ — Liabilities: Business combination-related contingent consideration 65,100 — — 65,100 Total $ 65,100 $ — $ — $ 65,100 |
Schedule of summary of changes in estimated acquisition related contingent consideration | The following table sets forth a summary of changes in the estimated fair value of the Company's Level 3 business combination-related contingent consideration for the six months ended June 30, 2021 ( in thousands ): Fair Value Measurements of Acquisition-Related Contingent Consideration Balance at January 1, 2021 $ 65,100 Changes in the fair value of contingent consideration 10,096 Contractual payments (2,276) Contractual payments included in accrued liabilities at June 30, 2021 (2,606) Foreign currency impact (114) Balance at June 30, 2021 $ 70,200 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of finite-lived amortizable intangible assets | The following table sets forth amortizable intangible assets as of June 30, 2021 and December 31, 2020 ( in thousands ): June 30, 2021 December 31, 2020 Finite-lived intangible assets $ 273,332 $ 264,676 Less: accumulated amortization (123,381) (111,487) Net carrying value $ 149,951 $ 153,189 |
Schedule of amortization expense | The following table summarizes amortization expense for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 288 $ 289 $ 574 $ 578 Selling, general and administrative 5,848 4,996 11,514 9,881 Total amortization expense $ 6,136 $ 5,285 $ 12,088 $ 10,459 |
CONVERTIBLE NOTES PAYABLE (Tabl
CONVERTIBLE NOTES PAYABLE (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt instruments | The composition of the Company’s 2025 Notes are as follows ( in thousands ): June 30, 2021 December 31, 2020 2.50% convertible senior notes due 2025 $ 276,000 $ 276,000 Unamortized debt discount (51,314) (56,384) Unamortized debt issuance costs (3,825) (4,277) Total 2025 Notes, net of unamortized debt discount and debt issuance costs $ 220,861 $ 215,339 The effective interest rate on the liability components of the 2025 Notes for the period from the date of issuance through June 30, 2021 was 7.7%. The following table sets forth total interest expense recognized related to the 2025 Notes ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Contractual interest expense $ 1,725 $ 1,725 $ 3,450 $ 3,450 Amortization of debt discount 2,560 2,371 5,071 4,698 Amortization of debt issuance costs 226 225 451 449 Total interest expense for the 2025 Notes $ 4,511 $ 4,321 $ 8,972 $ 8,597 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses at June 30, 2021 and December 31, 2020 consisted of the following ( in thousands ): June 30, 2021 December 31, 2020 Government rebates payable $ 11,756 $ 10,707 Compensation related costs 12,656 17,912 Accrued royalties and contingent consideration 8,340 7,857 Research and development 21,534 10,166 Selling, general and administrative 4,541 3,944 Miscellaneous accrued 3,638 6,207 Total accrued expenses $ 62,465 $ 56,793 |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of basic and diluted net loss per share | Basic and diluted net loss per share is calculated as follows (net loss amounts are stated in thousands) : Three Months Ended June 30, 2021 2020 Shares Net Loss Loss per common share Shares Net Loss Loss per common share Basic and diluted loss per share 60,571,259 $ (39,012) $ (0.64) 44,763,843 $ (26,068) $ (0.58) Six Months Ended June 30, 2021 2020 Shares Net Loss Loss per common share Shares Net Loss Loss per common share Basic and diluted loss per share 58,431,770 $ (92,879) $ (1.59) 43,943,370 $ (25,260) $ (0.57) |
Schedule of common stock options, convertible debt and restricted stock units anti-dilutive | The following common stock equivalents have been excluded because they were anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Restricted stock 1,591,426 1,517,338 1,614,123 1,437,383 Convertible debt 7,113,402 7,113,402 7,113,402 7,113,402 Options 9,367,565 8,479,710 9,298,480 8,327,753 Total anti-dilutive shares 18,072,393 17,110,450 18,026,005 16,878,538 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Schedule of service based restricted stock activity | The following table summarizes the Company’s service based restricted stock unit activity during the six months ended June 30, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2020 1,109,942 $ 17.84 Granted 800,797 25.49 Vested (365,492) 17.96 Forfeited/canceled (77,784) 21.42 Unvested June 30, 2021 1,467,463 $ 21.80 |
Schedule of performance based restricted stock activity | The following table summarizes the Company’s performance based restricted stock unit activity during the six months ended June 30, 2021: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Unvested December 31, 2020 167,500 $ 16.48 Granted — — Vested (75,000) 15.46 Forfeited/canceled — — Unvested June 30, 2021 92,500 $ 17.31 |
Schedule of stock option issuances and balances outstanding | The following table summarizes stock option activity during the six months ended June 30, 2021: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 8,242,996 $18.97 6.43 $ 71,641 Granted 1,518,307 26.36 Exercised (206,380) 14.90 Forfeited/canceled (225,803) 22.98 Outstanding at June 30, 2021 9,329,120 $20.17 6.42 $ 4,922 |
Schedule of share based compensation expenses | The following table sets forth total share-based compensation for the three and six months ended June 30, 2021 and 2020 ( in thousands ): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 2,845 $ 2,332 $ 5,847 $ 4,458 Selling, general & administrative 4,665 3,622 9,357 7,406 Total $ 7,510 $ 5,954 $ 15,204 $ 11,864 |
INVENTORY (Tables)
INVENTORY (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory, net of reserves, consisted of the following at June 30, 2021 and December 31, 2020 ( in thousands ): June 30, 2021 December 31, 2020 Raw materials $ 4,099 $ 3,219 Finished goods 3,310 4,389 Total inventory $ 7,409 $ 7,608 |
REVENUE RECOGNITION (Details)
REVENUE RECOGNITION (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Net product revenue | $ 54,617 | $ 48,430 | $ 102,024 | $ 96,199 |
Bile acid products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenue | 24,974 | 21,573 | 46,938 | 43,854 |
Tiopronin products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenue | $ 29,643 | $ 26,857 | $ 55,086 | $ 52,345 |
Geographic Concentration Risk | Revenue from Contract with Customer | North America | ||||
Disaggregation of Revenue [Line Items] | ||||
Concentration risk, percentage | 99.00% |
DEBT SECURITIES - Additional In
DEBT SECURITIES - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||
Proceeds from sale of debt securities | $ 242,100 | |
Purchase of debt securities | $ 406,000 | $ 36,743 |
DEBT SECURITIES - Marketable Se
DEBT SECURITIES - Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Total debt securities | $ 439,502 | $ 276,817 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total debt securities | 178,837 | 135,145 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total debt securities | 226,351 | 98,646 |
Securities of government sponsored entities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total debt securities | $ 34,314 | $ 43,026 |
DEBT SECURITIES - Available for
DEBT SECURITIES - Available for Sale Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities, available-for-sale, amortized cost basis, current | $ 328,100 | $ 271,098 |
Debt securities, available for sale unrealized gain, current | 215 | 724 |
Debt securities available for sale unrealized loss, current | (65) | (22) |
Debt securities, available-for-sale, current | 328,250 | 271,800 |
Debt securities, available-for-sale, amortized cost basis, noncurrent | 111,311 | |
Debt securities, available for sale unrealized gain, noncurrent | 6 | |
Debt securities available for sale unrealized loss, noncurrent | (65) | |
Debt securities, available-for-sale, noncurrent | 111,252 | |
Debt securities, available-for-sale, amortized cost | 439,411 | 276,111 |
Debt securities, available for sale, unrealized gains | 221 | 728 |
Debt securities, available-for-sale, unrealized gain (loss) | (130) | (22) |
Total available-for-sale securities | 439,502 | 276,817 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities, available-for-sale, amortized cost basis, current | 178,865 | 135,161 |
Debt securities, available for sale unrealized gain, current | 3 | 1 |
Debt securities available for sale unrealized loss, current | (31) | (17) |
Debt securities, available-for-sale, current | 178,837 | 135,145 |
Total available-for-sale securities | 178,837 | 135,145 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities, available-for-sale, amortized cost basis, current | 117,411 | 92,906 |
Debt securities, available for sale unrealized gain, current | 212 | 723 |
Debt securities available for sale unrealized loss, current | (29) | 0 |
Debt securities, available-for-sale, current | 117,594 | 93,629 |
Debt securities, available-for-sale, amortized cost basis, noncurrent | 108,811 | 5,013 |
Debt securities, available for sale unrealized gain, noncurrent | 6 | 4 |
Debt securities available for sale unrealized loss, noncurrent | (60) | 0 |
Debt securities, available-for-sale, noncurrent | 108,757 | 5,017 |
Total available-for-sale securities | 226,351 | 98,646 |
Securities of government sponsored entities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Debt securities, available-for-sale, amortized cost basis, current | 31,824 | 43,031 |
Debt securities, available for sale unrealized gain, current | 0 | 0 |
Debt securities available for sale unrealized loss, current | (5) | (5) |
Debt securities, available-for-sale, current | 31,819 | 43,026 |
Debt securities, available-for-sale, amortized cost basis, noncurrent | 2,500 | |
Debt securities, available for sale unrealized gain, noncurrent | 0 | |
Debt securities available for sale unrealized loss, noncurrent | (5) | |
Debt securities, available-for-sale, noncurrent | 2,495 | |
Total available-for-sale securities | $ 34,314 | $ 43,026 |
DEBT SECURITIES - Securities in
DEBT SECURITIES - Securities in an Unrealized Loss Position (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, fair value | $ 282,594 | $ 155,174 |
Less than 12 months, unrealized losses | 130 | 22 |
12 months or greater, fair value | 0 | 0 |
12 months or greater, unrealized losses | 0 | 0 |
Total, fair value | 282,594 | 155,174 |
Total, unrealized losses | 130 | 22 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, fair value | 132,356 | 112,148 |
Less than 12 months, unrealized losses | 31 | 17 |
12 months or greater, fair value | 0 | 0 |
12 months or greater, unrealized losses | 0 | 0 |
Total, fair value | 132,356 | 112,148 |
Total, unrealized losses | 31 | 17 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, fair value | 142,673 | 0 |
Less than 12 months, unrealized losses | 89 | 0 |
12 months or greater, fair value | 0 | 0 |
12 months or greater, unrealized losses | 0 | 0 |
Total, fair value | 142,673 | 0 |
Total, unrealized losses | 89 | 0 |
Securities of government-sponsored entities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, fair value | 7,565 | 43,026 |
Less than 12 months, unrealized losses | 10 | 5 |
12 months or greater, fair value | 0 | 0 |
12 months or greater, unrealized losses | 0 | 0 |
Total, fair value | 7,565 | 43,026 |
Total, unrealized losses | $ 10 | $ 5 |
ACQUISITIONS AND DISPOSITIONS (
ACQUISITIONS AND DISPOSITIONS (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Nov. 30, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | |
Business Acquisition [Line Items] | |||
Business combination-related contingent consideration | $ 70,200 | $ 65,100 | |
Orphan Technologies Limited | |||
Business Acquisition [Line Items] | |||
Cash paid for acquisition | $ 90,000 | ||
Closing price adjustments | 1,200 | ||
Liabilities assumed in acquisition | 1,800 | ||
Acquisition transaction costs | 4,200 | ||
Business combination-related contingent consideration | $ 427,000 |
LEASES - Additional Information
LEASES - Additional Information (Details) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021USD ($)lease | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)lease | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Apr. 30, 2019USD ($) | |
Leases [Abstract] | ||||||
Number of operating leases | lease | 1 | 1 | ||||
ROU asset | $ 24,416,000 | $ 24,416,000 | $ 34,600,000 | |||
Lease liability | 35,539,000 | 35,539,000 | 34,500,000 | |||
Lease incentive receivable | $ 7,900,000 | |||||
Operating lease extension term | 5 years | |||||
Aggregate base rent | $ 49,500,000 | |||||
Operating lease expense | $ 1,200,000 | $ 2,400,000 | ||||
Credit to operating lease expense | $ 200,000 | $ 0 |
LEASES - Future Minimum Rent Co
LEASES - Future Minimum Rent Commitments (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2021 | $ 1,842 | |
2022 | 6,020 | |
2023 | 6,200 | |
2024 | 6,386 | |
2025 | 6,578 | |
Thereafter | 18,535 | |
Total undiscounted future minimum payments | 45,561 | |
Lease incentives payable by lessor | (566) | |
Present value discount | (9,456) | |
Total lease liability | 35,539 | $ 34,500 |
Unamortized lease incentives, less incentives payable by lessor | (6,485) | |
Cash payments in excess of straight-line lease expense | (4,638) | |
Total ROU asset | $ 24,416 | $ 34,600 |
LEASES - Supplemental Balance S
LEASES - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |
Other current liabilities | $ 2,623 | |
Other non-current liabilities | 32,916 | |
Total lease liabilities | $ 35,539 | $ 34,500 |
FAIR VALUE MEASUREMENTS - Addit
FAIR VALUE MEASUREMENTS - Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)business | Jun. 30, 2020USD ($) | Sep. 10, 2018 | |
Business Acquisition [Line Items] | |||||
Number of businesses acquired | business | 2 | ||||
Fair value of convertible debt | $ 234,700 | $ 234,700 | |||
Change in fair value of contingent consideration | $ 1,509 | $ 4,286 | $ 10,096 | $ 2,363 | |
Senior Notes | Senior Notes Due 2025 | |||||
Business Acquisition [Line Items] | |||||
Interest rate percentage | 2.50% | 2.50% | 2.50% |
FAIR VALUE MEASUREMENTS - Disco
FAIR VALUE MEASUREMENTS - Discount Rates Used (Details) | Jun. 30, 2021 | Dec. 31, 2020 |
Payment Discount | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.0785 | 0.0745 |
Cholbam | Revenue Discount | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.065 | 0.065 |
Chenodal | Revenue Discount | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.075 | 0.085 |
FAIR VALUE MEASUREMENTS - Asset
FAIR VALUE MEASUREMENTS - Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Assets: | ||||
Cash and cash equivalents | $ 83,288 | $ 84,772 | $ 237,170 | $ 62,436 |
Total debt securities | 439,502 | 276,817 | ||
Total | 522,790 | 361,589 | ||
Liabilities: | ||||
Business combination-related contingent consideration | 70,200 | 65,100 | ||
Total | 70,200 | 65,100 | ||
Quoted prices in active markets (Level 1) | ||||
Assets: | ||||
Cash and cash equivalents | 83,288 | 84,772 | ||
Total debt securities | 0 | 0 | ||
Total | 83,288 | 84,772 | ||
Liabilities: | ||||
Business combination-related contingent consideration | 0 | 0 | ||
Total | 0 | 0 | ||
Significant other observable inputs (Level 2) | ||||
Assets: | ||||
Cash and cash equivalents | 0 | 0 | ||
Total debt securities | 439,502 | 276,817 | ||
Total | 439,502 | 276,817 | ||
Liabilities: | ||||
Business combination-related contingent consideration | 0 | 0 | ||
Total | 0 | 0 | ||
Significant unobservable inputs (Level 3) | ||||
Assets: | ||||
Cash and cash equivalents | 0 | 0 | ||
Total debt securities | 0 | 0 | ||
Total | 0 | 0 | ||
Liabilities: | ||||
Business combination-related contingent consideration | 70,200 | 65,100 | ||
Total | $ 70,200 | $ 65,100 |
FAIR VALUE MEASUREMENTS - Acqui
FAIR VALUE MEASUREMENTS - Acquisition-related Contingent Consideration (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Change in fair value of contingent consideration | $ 1,509 | $ 4,286 | $ 10,096 | $ 2,363 |
Level 3 | ||||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Beginning balance | 65,100 | |||
Change in fair value of contingent consideration | 10,096 | |||
Contractual payments | (2,276) | |||
Contractual payments included in accrued liabilities at June 30, 2021 | (2,606) | |||
Foreign currency impact | (114) | |||
Ending balance | $ 70,200 | $ 70,200 |
INTANGIBLE ASSETS - Additional
INTANGIBLE ASSETS - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Net book value of amortizable intangible assets | $ 149,951 | $ 153,189 |
INTANGIBLE ASSETS - Amortizable
INTANGIBLE ASSETS - Amortizable Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Finite-lived intangible assets | $ 273,332 | $ 264,676 |
Less: accumulated amortization | (123,381) | (111,487) |
Net carrying value | $ 149,951 | $ 153,189 |
INTANGIBLE ASSETS - Amortizatio
INTANGIBLE ASSETS - Amortization (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | $ 6,136 | $ 5,285 | $ 12,088 | $ 10,459 |
Research and development | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | 288 | 289 | 574 | 578 |
Selling, general and administrative | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Total amortization expense | $ 5,848 | $ 4,996 | $ 11,514 | $ 9,881 |
CONVERTIBLE NOTES PAYABLE - Add
CONVERTIBLE NOTES PAYABLE - Additional Information (Details) $ / shares in Units, $ in Millions | Sep. 10, 2018USD ($) | Jun. 30, 2021USD ($)day$ / shares |
Debt Instrument [Line Items] | ||
Fair value of convertible debt | $ 234.7 | |
Senior Notes | Senior Notes Due 2025 | ||
Debt Instrument [Line Items] | ||
Long-term debt, excluding current maturities | $ 276 | $ 276 |
Interest rate percentage | 2.50% | 2.50% |
Proceeds from issuance of debt | $ 267.2 | |
Debt instrument, convertible, threshold percentage of stock price trigger | 130.00% | |
Conversion ratio | 0.0257739 | |
Conversion price (in dollars per share) | $ / shares | $ 38.80 | |
Convertible debt, market price (in dollars per share) | $ / shares | $ 0.851 | |
Debt conversion, liability | $ 198.6 | |
Debt conversion, equity | $ 77.4 | |
Debt instrument term | 7 years | |
Debt issuance costs, net | $ 8.8 | |
Debt instrument, interest rate, effective percentage | 7.70% | |
Debt redeemable upon bankruptcy insolvency | 100.00% | |
Senior Notes | Convertible Notes Due 2019 | ||
Debt Instrument [Line Items] | ||
Interest rate percentage | 4.50% | |
Debt instrument, repurchase amount | $ 23.4 | |
Senior Notes | Convertible Notes Due 2019 | Debt Conversion, Scenario One | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold trading days | day | 20 | |
Debt instrument, convertible, threshold consecutive trading days | day | 30 | |
Debt instrument, convertible, threshold percentage of stock price trigger | 130.00% | |
Senior Notes | Convertible Notes Due 2019 | Debt Conversion, Scenario Two | ||
Debt Instrument [Line Items] | ||
Debt instrument, convertible, threshold trading days | day | 5 | |
Debt instrument, convertible, threshold consecutive trading days | day | 10 | |
Debt instrument, convertible, threshold percentage of stock price trigger | 98.00% |
CONVERTIBLE NOTES PAYABLE - Com
CONVERTIBLE NOTES PAYABLE - Composition of Notes (Details) - Senior Notes - Senior Notes Due 2025 - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Sep. 10, 2018 |
Debt Instrument [Line Items] | |||
Interest rate percentage | 2.50% | 2.50% | |
2.50% convertible senior notes due 2025 | $ 276,000 | $ 276,000 | |
Unamortized debt discount | (51,314) | (56,384) | |
Unamortized debt issuance costs | (3,825) | (4,277) | |
Total 2025 Notes, net of unamortized debt discount and debt issuance costs | $ 220,861 | $ 215,339 |
CONVERTIBLE NOTES PAYABLE - Sch
CONVERTIBLE NOTES PAYABLE - Schedule of Interest Expense (Details) - Senior Notes - Senior Notes Due 2025 - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Debt Instrument [Line Items] | ||||
Contractual interest expense | $ 1,725 | $ 1,725 | $ 3,450 | $ 3,450 |
Amortization of debt discount | 2,560 | 2,371 | 5,071 | 4,698 |
Amortization of debt issuance costs | 226 | 225 | 451 | 449 |
Total interest expense for the 2025 Notes | $ 4,511 | $ 4,321 | $ 8,972 | $ 8,597 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Government rebates payable | $ 11,756 | $ 10,707 |
Compensation related costs | 12,656 | 17,912 |
Accrued royalties and contingent consideration | 8,340 | 7,857 |
Research and development | 21,534 | 10,166 |
Selling, general and administrative | 4,541 | 3,944 |
Miscellaneous accrued | 3,638 | 6,207 |
Total accrued expenses | $ 62,465 | $ 56,793 |
NET LOSS PER COMMON SHARE - EPS
NET LOSS PER COMMON SHARE - EPS Reconciliation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share [Abstract] | ||||
Basic shares outstanding (in shares) | 60,571,259 | 44,763,843 | 58,431,770 | 43,943,370 |
Diluted shares outstanding (in shares) | 60,571,259 | 44,763,843 | 58,431,770 | 43,943,370 |
Net loss | $ (39,012) | $ (26,068) | $ (92,879) | $ (25,260) |
Basic net loss per common share (in dollars per share) | $ (0.64) | $ (0.58) | $ (1.59) | $ (0.57) |
Diluted net loss per common share (in dollars per share) | $ (0.64) | $ (0.58) | $ (1.59) | $ (0.57) |
NET LOSS PER COMMON SHARE - Ant
NET LOSS PER COMMON SHARE - Antidilutive Shares (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Total anti-dilutive shares | ||||
Anti-dilutive shares excluded from the calculation (in shares) | 18,072,393 | 17,110,450 | 18,026,005,000 | 16,878,538,000 |
Restricted stock | ||||
Total anti-dilutive shares | ||||
Anti-dilutive shares excluded from the calculation (in shares) | 1,591,426 | 1,517,338 | 1,614,123,000 | 1,437,383,000 |
Convertible debt | ||||
Total anti-dilutive shares | ||||
Anti-dilutive shares excluded from the calculation (in shares) | 7,113,402 | 7,113,402 | 7,113,402,000 | 7,113,402,000 |
Options | ||||
Total anti-dilutive shares | ||||
Anti-dilutive shares excluded from the calculation (in shares) | 9,367,565 | 8,479,710 | 9,298,480,000 | 8,327,753,000 |
SHARE-BASED COMPENSATION - Serv
SHARE-BASED COMPENSATION - Service Based Restricted Stock Activity (Details) - Restricted stock units $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Number of Restricted Stock Units | |
Beginning balance (in shares) | shares | 1,109,942 |
Granted (in shares) | shares | 800,797 |
Vested (in shares) | shares | (365,492) |
Forfeited/canceled (in shares) | shares | (77,784) |
Ending balance (in share) | shares | 1,467,463 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 17.84 |
Granted (in dollars per share) | $ / shares | 25.49 |
Vested (in dollars per share) | $ / shares | 17.96 |
Forfeited/canceled (in dollars per share) | $ / shares | 21.42 |
Ending balance (in dollars per share) | $ / shares | $ 21.80 |
Unamortized stock compensation expense | $ | $ 28 |
Weighted-average recognition period (in years) | 2 years 9 months 18 days |
SHARE-BASED COMPENSATION - Perf
SHARE-BASED COMPENSATION - Performance Based Restricted Stock Activity (Details) - Performance Shares $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Number of Restricted Stock Units | |
Beginning balance (in shares) | shares | 167,500 |
Granted (in shares) | shares | 0 |
Vested (in shares) | shares | (75,000) |
Forfeited/canceled (in shares) | shares | 0 |
Ending balance (in share) | shares | 92,500 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 16.48 |
Granted (in dollars per share) | $ / shares | 0 |
Vested (in dollars per share) | $ / shares | 15.46 |
Forfeited/canceled (in dollars per share) | $ / shares | 0 |
Ending balance (in dollars per share) | $ / shares | $ 17.31 |
Unamortized stock compensation expense | $ | $ 0.1 |
Weighted-average recognition period (in years) | 8 months 12 days |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Weighted Average Exercise Price | ||
Number of shares exercisable (in shares) | shares | 6,200,000 | |
Weighted average exercise price (in dollars per share) | $ / shares | $ 19.23 | |
Stock Options | ||
Shares Underlying Options | ||
Beginning balance (in shares) | shares | 8,242,996 | |
Granted (in shares) | shares | 1,518,307 | |
Exercised (in shares) | shares | (206,380) | |
Forfeited/canceled (in shares) | shares | (225,803) | |
Ending balance (in shares) | shares | 9,329,120 | 8,242,996 |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ / shares | $ 18.97 | |
Granted (in dollars per share) | $ / shares | 26.36 | |
Exercised (in dollars per share) | $ / shares | 14.90 | |
Forfeited/canceled (in dollars per share) | $ / shares | 22.98 | |
Ending balance (in dollars per share) | $ / shares | $ 20.17 | $ 18.97 |
Weighted Average Remaining Contractual Life (years) | 6 years 5 months 1 day | 6 years 5 months 4 days |
Aggregate Intrinsic Value (in thousands) | $ | $ 4,922 | $ 71,641 |
Unamortized stock compensation expense | $ | $ 37,200 | |
Weighted-average recognition period (in years) | 2 years 8 months 12 days |
SHARE-BASED COMPENSATION - St_2
SHARE-BASED COMPENSATION - Stock based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 7,510 | $ 5,954 | $ 15,204 | $ 11,864 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 2,845 | 2,332 | 5,847 | 4,458 |
Selling, general & administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,665 | $ 3,622 | $ 9,357 | $ 7,406 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense (benefit) | $ 49 | $ 65 | $ 362 | $ (18,911) |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,099 | $ 3,219 |
Finished goods | 3,310 | 4,389 |
Total inventory | 7,409 | 7,608 |
Inventory reserve | $ 3,500 | $ 3,600 |
ACCOUNTS RECEIVABLE (Details)
ACCOUNTS RECEIVABLE (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Receivables [Abstract] | ||
Accounts receivable, net | $ 11,860 | $ 15,925 |
EQUITY OFFERINGS (Details)
EQUITY OFFERINGS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 17 Months Ended | ||||||
Feb. 28, 2021 | Jun. 30, 2020 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | May 18, 2021 | May 17, 2021 | Dec. 31, 2020 | Feb. 29, 2020 | |
Class of Stock [Line Items] | ||||||||||
Common stock shares authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | 100,000,000 | 100,000,000 | |||||
Underwritten Equity Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares authorized in sale (in shares) | 7,500,000 | 7,500,000 | ||||||||
Sales price per share (in dollars per share) | $ 26.75 | $ 15.50 | $ 15.50 | |||||||
Proceeds from issuance of common stock | $ 189,300 | $ 108,700 | $ 189,278 | $ 108,644 | ||||||
At-The-Market Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares authorized in sale (in shares) | 184,186 | 1,051,992 | ||||||||
Proceeds from issuance of common stock | $ 4,900 | 4,878 | $ 0 | $ 28,600 | ||||||
Aggregate offering amount authorized | $ 100,000 | |||||||||
Remaining offering amount authorized | $ 71,400 | $ 71,400 |