Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 28, 2023 | Jun. 30, 2022 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-40880 | ||
Entity Registrant Name | XERIS BIOPHARMA HOLDINGS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 87-1082097 | ||
Entity Address, Address Line One | 180 N. LaSalle Street | ||
Entity Address, Address Line Two | Suite 1600 | ||
Entity Address, City or Town | Chicago | ||
Entity Address, State or Province | IL | ||
Entity Address, Postal Zip Code | 60601 | ||
City Area Code | 844 | ||
Local Phone Number | 445-5704 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | XERS | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 209.3 | ||
Entity Common Stock, Shares Outstanding | 137,288,602 | ||
Entity Central Index Key | 0001867096 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | KPMG LLP |
Auditor Location | Chicago, Illinois |
Auditor Firm ID | 185 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 121,966,000 | $ 67,271,000 |
Short-term Investments | 0 | 35,162,000 |
Trade accounts receivable, net | 30,830,000 | 17,456,000 |
Inventory | 24,735,000 | 18,118,000 |
Prepaid expenses and other current assets | 9,287,000 | 4,589,000 |
Total current assets | 186,818,000 | 142,596,000 |
Property and equipment, net | 5,516,000 | 6,627,000 |
Operating lease right-of-use assets | 3,992,000 | 0 |
Goodwill | 22,859,000 | 22,859,000 |
Intangible Assets, Net (Excluding Goodwill) | 120,607,000 | 131,450,000 |
Other assets | 4,730,000 | 829,000 |
Total assets | 344,522,000 | 304,361,000 |
Current Liabilities | ||
Accounts payable | 4,606,000 | 8,924,000 |
Current operating lease liabilities | 1,580,000 | 0 |
Other accrued liabilities | 36,786,000 | 49,088,000 |
Accrued trade discounts and rebates | 16,818,000 | 15,041,000 |
Accrued returns reserve | 11,173,000 | 4,000,000 |
Other current liabilities | 2,658,000 | 1,987,000 |
Total current liabilities | 73,621,000 | 79,040,000 |
Long-term debt, net of unamortized debt issuance costs | 187,075,000 | 88,067,000 |
Non-current operating lease liabilities | 9,402,000 | 0 |
Contingent value rights | 25,688,000 | 22,531,000 |
Supply agreement liability, less current portion | 0 | 5,991,000 |
Deferred rent | 0 | 6,883,000 |
Deferred tax liabilities | 3,518,000 | 4,942,000 |
Other liabilities | 31,000 | 1,676,000 |
Total liabilities | 299,335,000 | 209,130,000 |
Commitments and contingencies (Note 9) | ||
Stockholders' Equity | ||
Preferred stock, par value $0.0001 | 0 | 0 |
Common stock, par value $0.0001 | 14,000 | 13,000 |
Additional paid in capital | 599,966,000 | 555,359,000 |
Accumulated deficit | (554,770,000) | (460,110,000) |
Accumulated other comprehensive income (loss) | (23,000) | (31,000) |
Total stockholders' equity | 45,187,000 | 95,231,000 |
Total liabilities and stockholders' equity | $ 344,522,000 | $ 304,361,000 |
Preferred stock shares issued (in shares) | 0 |
Consolidated Balance Sheets Par
Consolidated Balance Sheets Parenthetical - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position Parenthetical [Abstract] | ||
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock shares outstanding (in shares) | 0 | 0 |
Preferred stock shares issued (in shares) | 0 | |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock shares authorized (in shares) | 350,000,000 | 350,000,000 |
Common stock shares issues (in shares) | 136,273,090 | 124,873,316 |
Common stock shares outstanding (in shares) | 136,273,090 | 124,873,316 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Net sales | $ 110,248 | $ 49,590 |
Operating expenses | ||
Cost of goods sold | 22,634 | 13,318 |
Research and development | 20,966 | 25,160 |
Selling, general and administrative | 137,745 | 125,718 |
Amortization of Intangible Assets | 10,843 | 550 |
Total operating expenses | 192,188 | 164,746 |
Loss from operations | (81,940) | (115,156) |
Other income (expense) | ||
Interest and other income | 2,578 | 313 |
Interest expense | 15,325 | 7,180 |
Change in fair value of warrants | 1,760 | (702) |
Change in fair value of contingent value rights | (3,157) | 0 |
Other income (expense) | (14,144) | (7,569) |
Net loss before benefit from income taxes | (96,084) | (122,725) |
Benefit from income taxes | 1,424 | 0 |
Net loss | (94,660) | (122,725) |
Other comprehensive income (loss), net of tax | ||
Unrealized gains (losses) on investments | 7 | (38) |
Foreign currency translation adjustments | 1 | 1 |
Comprehensive loss | $ (94,652) | $ (122,762) |
Net loss per common share - basic (in dollars per share) | $ (0.70) | $ (1.55) |
Net loss per common share - Diluted (in dollars per share) | $ (0.70) | $ (1.55) |
Weighted average common shares outstanding - basic (in shares) | 135,628,721 | 79,027,062 |
Weighted average common shares outstanding - Diluted (in shares) | 135,628,721 | 79,027,062 |
Product revenue, net | ||
Net sales | $ 109,263 | $ 49,280 |
Royalty, contract and other revenue | ||
Net sales | $ 985 | $ 310 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Shares, Issued, Beginning Balance at Dec. 31, 2020 | 59,611,202 | ||||
Stockholders' Equity Attributable to Parent, Beginning Balance at Dec. 31, 2020 | $ 33,761 | $ 6 | $ 371,134 | $ 6 | $ (337,385) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (122,725) | (122,725) | |||
Issuance of common stock upon equity offerings, shares | 6,553,398 | ||||
Issuance of common stock upon equity offerings, value | 26,925 | $ 1 | 26,924 | ||
Issuance of common stock in connection with the Transactions (in shares) | 58,082,606 | ||||
Issuance of common stock in connection with the Transactions | 137,655 | $ 6 | 137,649 | ||
Issuance of equity awards to Strongbridge equity award holders in connection with the Transactions | 7,964 | 7,964 | |||
Exercise and vesting of stock options, shares | 93,399 | ||||
Exercise and vesting of stock options, value | 199 | 199 | |||
Stock Issued During Period, Shares, Vesting Of Restricted Stock Units | 316,772 | ||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | (534) | (534) | |||
Stock-based compensation | 11,381 | 11,381 | |||
Issuance of common stock through employee stock purchase plan (in shares) | 215,939 | ||||
Issuance of common stock through employee stock purchase plan, value | 642 | 642 | |||
Other comprehensive loss | (37) | (37) | |||
Shares, Issued at Dec. 31, 2021 | 124,873,316 | ||||
Stockholders' Equity Attributable to Parent at Dec. 31, 2021 | 95,231 | $ 13 | 555,359 | (31) | (460,110) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (94,660) | (94,660) | |||
Issuance of common stock upon equity offerings, shares | 10,238,908 | ||||
Issuance of common stock upon equity offerings, value | $ 30,000 | $ 1 | 29,999 | ||
Exercise and vesting of stock options, shares | 11,228 | 11,228 | |||
Exercise and vesting of stock options, value | $ 8 | 8 | |||
Adjustments to Additional Paid in Capital, Warrant Issued | 2,080 | 2,080 | |||
Stock Issued During Period, Shares, Vesting Of Restricted Stock Units | 477,771 | ||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures | (468) | (468) | |||
Stock-based compensation | 12,160 | 12,160 | |||
Issuance of common stock through employee stock purchase plan (in shares) | 671,867 | ||||
Issuance of common stock through employee stock purchase plan, value | 828 | 828 | |||
Other comprehensive loss | 8 | 8 | |||
Shares, Issued at Dec. 31, 2022 | 136,273,090 | ||||
Stockholders' Equity Attributable to Parent at Dec. 31, 2022 | $ 45,187 | $ 14 | $ 599,966 | $ (23) | $ (554,770) |
Consolidated Statement of Cash
Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (94,660) | $ (122,725) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 1,399 | 1,329 |
Amortization of Intangible Assets | 10,843 | 550 |
Amortization of investments | (184) | (413) |
Amortization of debt issuance costs | 1,559 | 961 |
Amortization of operating right-of-use assets | 426 | 0 |
Deferred income tax benefit | (1,424) | 0 |
Stock-based compensation | 12,160 | 11,381 |
Loss on extinguishment of debt | (1,223) | 0 |
Loss on disposal of property and equipment | 236 | 0 |
Gain on the remeasurement of lease liabilities | (1,084) | 0 |
Change in fair value of warrants | (1,760) | 702 |
Change in fair value of contingent value rights | 3,157 | 0 |
Changes in operating assets and liabilities | ||
Trade accounts receivable | 13,374 | 6,237 |
Prepaid expenses and other current assets | 3,887 | (3,290) |
Inventory | 7,465 | 7,418 |
Accounts payable | (4,318) | 5,527 |
Other accrued liabilities | (11,384) | 12,556 |
Accrued trade discounts and rebates | 1,777 | 4,213 |
Accrued returns reserve | 7,173 | 1,110 |
Supply agreement liabilities | (5,280) | 0 |
Operating lease liabilities | (899) | 0 |
Other | 2,507 | (1,187) |
Net cash used in operating activities | (102,891) | (95,535) |
Cash flows from investing activities | ||
Capital expenditures | (524) | (1,085) |
Payments to Acquire Investments | 0 | (43,020) |
Sales and maturities of investments | 34,985 | 103,600 |
Cash acquired through acquisition of business | 0 | 38,469 |
Net cash used in investing activities | 34,461 | 97,964 |
Cash flows from financing activities | ||
Proceeds from equity offerings | 30,000 | 27,000 |
Payments of Stock Issuance Costs | 0 | (54) |
Proceeds from issuance of debt | 146,214 | 0 |
Repayments of Long-term Debt | 43,496 | 0 |
Payments of debt issuance costs | 4,876 | 0 |
Payments for loss on extinguishment of debt | (737) | 0 |
Proceeds from issuance of employee stock purchase plan shares | 828 | 642 |
Proceeds from exercise of stock awards | 8 | 193 |
Repurchase of common stock withheld for taxes | 468 | 534 |
Net cash provided by financing activities | 127,473 | 27,247 |
Effect of exchange rate on cash and cash equivalents | 0 | (3) |
Increase (decrease) in cash and cash equivalents | 59,043 | 29,673 |
Cash and cash equivalents, beginning of period | 67,271 | 37,598 |
Cash and cash equivalents, end of period | 126,314 | 67,271 |
Supplemental schedule of cash flow information | ||
Cash paid for interest | 10,859 | 7,294 |
Supplemental schedule of non-cash investing and financing activities | ||
Issuance of warrants related to loan agreement | 2,080 | 0 |
Initial operating lease right-of-use assets for adoption of ASU 2016-02 | 0 | |
Stock issued in connection with the Acquisition | 0 | 137,655 |
Initial fair value of equity awards and PIPE warrants consideration at acquisition date | 0 | 8,871 |
Initial fair value of contingent consideration at acquisition date | 0 | 22,531 |
Cash flows from operating activities: | ||
Cash and cash equivalents | 121,966 | 67,271 |
Restricted cash included in Other assets | 4,348 | 0 |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | 126,314 | 67,271 |
Accounting Standards Update 2016-02 | ||
Supplemental schedule of non-cash investing and financing activities | ||
Initial operating lease right-of-use assets for adoption of ASU 2016-02 | (6,277) | 0 |
Initial current and non-current operating lease liabilities for adoption of ASU 2016-02 | $ 14,013 | $ 0 |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Parenthetical) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) [Abstract] | ||
Shares withheld for tax (in shares) | 231,324 | 141,644 |
Organization and Nature of the
Organization and Nature of the Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Nature of the Business | Organization and nature of the business Nature of business Xeris Biopharma Holdings, Inc. ("Xeris Biopharma" or the "Company") is a growth-oriented biopharmaceutical company committed to improving patients' lives by developing and commercializing clinically meaningful products across a range of therapies. The Company currently has three commercially available products: Gvoke, a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia; Keveyis, the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis ("PPP"); and Recorlev, approved by the Food and Drug Administration ("FDA") in December 2021, a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome. The Company also has a pipeline of development programs to bring new products forward using its proprietary formulation science, XeriSol TM and XeriJect TM . On October 5, 2021, Xeris Pharmaceuticals, Inc. ("Xeris Pharma") acquired Strongbridge Biopharma plc ("Strongbridge"), a biopharmaceutical company commercializing therapies for rare diseases with significant unmet needs. Immediately following the acquisition and related transactions, both Xeris Pharma and Strongbridge became wholly-owned subsidiaries of Xeris Biopharma. The common stock of Xeris Pharma and the ordinary shares of Strongbridge were de-registered after completion of the Transactions (as defined below in Note 4). On October 6, 2021, Xeris Biopharma’s common stock, par value $0.0001 per share, commenced trading on the Nasdaq Global Select Market (“Nasdaq”) under the ticker symbol "XERS". See "Note 4 – Business combination" for a more detailed description of the Transactions. As used herein, the "Company" or "Xeris" refers to Xeris Pharma when referring to periods prior to the acquisition of Strongbridge on October 5, 2021 and to Xeris Biopharma when referring to periods on or subsequent to October 5, 2021. Throughout this document, unless otherwise noted, references to Gvoke include Gvoke PFS, Gvoke HypoPen, Gvoke Kit and Ogluo (glucagon). Liquidity and capital resources The Company has incurred operating losses since inception and has an accumulated deficit of $554.8 million as of December 31, 2022. The Company expects to continue to incur net losses for at least the next 12 months beyond the issuance date of these consolidated financial statements. Based on the Company’s current operating plans, existing working capital at December 31, 2022, capital raised in 2022, the Company believes that its cash resources are sufficient to sustain operations and capital expenditure requirements for at least the next 12 months from the issuance date of these consolidated financial statements. If needed, the Company may elect to finance its operations through equity or debt financing along with revenues. There can be no assurance that such funding may be available to the Company on acceptable terms, or at all, or that the Company will be able to successfully market and sell Gvoke, Keveyis and Recorlev. Market volatility resulting from COVID-19, geopolitical instability resulting from the ongoing military conflict between Russia and Ukraine, rising interest rates, inflationary pressures, the tightening of lending standards or other factors could also adversely impact the Company's ability to access capital as and when needed. The issuance of equity securities may result in dilution to stockholders. If the Company raises additional funds through the issuance of additional debt, which may have rights, preferences and privileges senior to those of the Company's common stockholders, the terms of the debt could impose significant restrictions on the Company's operations. The failure to raise funds as and when needed could have a negative impact on the Company's financial condition and ability to pursue its business strategies. If additional funding is not secured when required, the Company may need to delay or curtail its operations until such funding is received, which would have a material adverse impact on the business prospects and results of operations. Significant risks The Company is subject to a number of risks similar to other specialty pharmaceutical companies, including, but not limited to, successful commercialization and market acceptance of available products and any future products, if and when approved, successful development of the product candidates, the development of new technological innovations by competitors, and protection of intellectual property. The ongoing COVID-19 pandemic has resulted in significant governmental measures being implemented to control the spread of the virus and has caused the Company to modify its business practices (including remote work for most of its employees from time to time). While the Company cannot predict the scope and severity, these developments and measures could materially and adversely affect the business, results of operations and financial condition. The Company is continuing to closely monitor the impact of the COVID-19 pandemic on all aspects of the business and is taking steps to minimize the impact on the business. However, the extent to which COVID-19 impacts the business, results of operations or financial condition will depend on the extent and severity of the continued spread of COVID-19 globally, the effectiveness of actions taken to contain the pandemic or treat its impact, and the resulting economic consequences, among others. Furthermore, if the Company or any of the third parties with whom the Company engages were to experience shutdowns or other business disruptions, the Company's ability to conduct the business in the manner and |
Basis of presentation and summa
Basis of presentation and summary of significant accounting policies and estimates | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation and summary of significant accounting policies and estimates | Basis of presentation and summary of significant accounting policies and estimates Basis of presentation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP"). In the opinion of management, the accompanying consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented. The results of operations for such periods are not necessarily indicative of the results that may be expected for any future period. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") issued by the Financial Accounting Standards Board ("FASB"). Basis of consolidation These consolidated financial statements include the financial statements of Xeris Biopharma Holdings, Inc. and subsidiaries. All intercompany transactions have been eliminated. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses included in the financial statements and accompanying notes. Actual results could differ from those estimates. Revenue recognition The Company applies the guidance in ASC 606, Revenue Recognition , to all contracts with customers within the scope of the standard. The Company sells product primarily to wholesalers or a specialty pharmacy that subsequently resell to retail pharmacies or patients. The Company enters into arrangements with payors, group purchasing organizations, and healthcare providers that provide for government-mandated or privately-negotiated rebates, chargebacks and discounts related to the Company’s products. The Company currently sells Gvoke, Keveyis and Recorlev in the United States only. Revenue is recognized when the Company's customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods or services, which is when the Company's obligations under the terms of the contract with the customer are satisfied, based on the consideration the Company expects to receive in exchange for those goods or services. Revenues are recorded at the net product sales price, which includes estimated allowances for patient copay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to the pharmaceutical wholesaler or other customer. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, adjustments are made to these allowances in the period in which the actual results or updates to estimates become known. Patient Copay Assistance Program The Company offers savings programs to commercially insured patients under which the cost of a prescription to a patient is discounted. The Company reimburses pharmacies for this discount through a third-party vendor. The Company records an accrual to reduce gross sales for the estimated copay on units sold to wholesalers and other customers. The estimate is based on estimated percentages of products that will be prescribed to qualified patients, expected patient utilization of the discount program, average assistance paid based on reporting from the third-party vendor as well as industry data and estimated levels of inventory in the distribution channel. Accrued copay fees are recorded as a reduction of product revenue and included in accrued trade discounts and rebates on the consolidated balance sheets. Commercial Rebates The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, to provide rebates with respect to utilization of the products and contracted formulary status. The Company accrues estimated rebates based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and records the rebate as a reduction of product revenue. Accrued commercial rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Government Rebates The Company participates in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Program. The Company accrues estimated rebates and discounts based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and records the rebates as a reduction of product revenue. Accrued government rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Chargebacks The Company arranges with certain commercial and government entities allowing them to buy products directly from wholesalers at specific prices. These entities purchase products through wholesalers at the discounted price and the wholesalers charge the difference between their list price and the discounted price back to the Company. The Company accrues estimated chargebacks based on estimated percentages of products sold to these entities, contract prices, and estimated levels of inventory in the distribution channel and records the chargebacks as a reduction of product revenue. Accrued chargebacks are recorded as an allowance against trade receivables on the consolidated balance sheets. Product Returns For some products, the Company's customers generally have the right to return product during the period beginning six months prior to the product expiration date and up to one year after the product expiration date. The Company does not have extensive history of product returns and uses various factors to estimate the provision for returns, including the launch date of products, third-party industry data for comparable products in the market and estimated channel inventory data. In a reporting period, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. While the Company believes that the returns reserve is sufficient to avoid a significant reversal of revenue in future periods, if it were to increase or decrease the rate by 1%, it would have a $1.1 million impact on revenue in the year ended December 31, 2022. The Company records estimated product returns in accrued returns reserve on the consolidated balance sheets and as a reduction of product revenue. Prompt Payment Discounts As an incentive for prompt payment, the Company offers a discount to most customers. The Company expects that all eligible customers will comply with the contractual terms to earn the discount, and, therefore, the Company accrues the discount on all eligible sales. The Company records the discount as an allowance against trade accounts receivable on the consolidated balance sheets and as a reduction of product revenue. Service Fees The Company records service fees paid to the wholesaler and specialty pharmacy customers for distribution and inventory management services as a reduction to product revenue. The Company accrues estimated service fees based on contractually determined amounts. Accrued service fees are included in accrued trade discounts and rebates on the consolidated balance sheets. Concentration of credit risk For the years ended December 31, 2022 and 2021, four customers accounted for 96% and 95% of the Company’s gross product revenue, respectively. At both December 31, 2022 and December 31, 2021, the same four customers accounted for 99% of the trade accounts receivable, net. Cost of goods sold Cost of goods sold includes primarily product costs, which include all costs directly related to the purchase of raw materials, charges from contract manufacturing organizations, and manufacturing overhead costs, including shipping and distribution charges. Cost of goods sold also includes losses on excess, slow-moving or obsolete inventory and inventory purchase commitments, if any. Manufacturing costs for Gvoke and Recorlev incurred prior to approval and initial commercialization were expensed as research and development expenses. The Company does not incur material cost of goods sold related to royalty, contract and other revenue. Research and development expenses Research and development expenses are expensed as incurred. Research and development expenses include salaries, stock compensation and other personnel-related costs, consulting fees, fees paid for contract research and development services including those for preclinical and clinical trials, laboratory equipment and facilities costs, and other external costs. In addition, manufacturing costs of products prior to approval and initial commercialization are expensed as research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are received, the services are performed, or the arrangement is terminated. Stock-based compensation expense The Company accounts for stock-based compensation awards in accordance with ASC 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments, including stock options, restricted stock units and employee stock purchases, to be recognized in the statements of operations based on their grant date fair values. The Company estimates the grant date fair value of each option award using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, the risk-free interest rate and the expected dividend yield of the common stock. Restricted stock units are valued based on the fair market value of the Company’s common stock on the date they were granted. The Company recognizes stock-based compensation expense equal to the grant date fair value of stock options, restricted stock units and employee stock purchases on a straight-line basis over the requisite service period. The Company accounts for forfeitures as they are incurred. Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines the deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company's policy is to include interest and penalties related to uncertain tax positions, if any, within the provision for taxes in the statements of operations and comprehensive loss. For the years ended December 31, 2022 and 2021, the Company did not accrue any interest or penalties on uncertain tax positions. Cash and cash equivalents The Company considers all demand deposits with financial institutions and highly liquid investments with an original maturity of three months or less when purchased as cash equivalents. Restricted Cash Restricted cash includes amounts required to be held as a security deposit in the form of letters of credit for the Company to secure leases and state licenses. Investments The Company classifies investments in debt securities as available-for-sale investments. Investments classified as short-term on the balance sheets have original maturities of greater than 90 days but less than one year. Inventory Inventory is stated at the lower of cost or net realizable value, using the first-in, first-out convention. Inventory consists of raw materials, work in process and finished goods. The Company has entered into manufacturing and supply agreements for the manufacture or purchase of raw materials and production supplies. The Company’s inventory includes the direct purchase cost of materials and supplies, charges from contract manufacturing organizations and manufacturing overhead costs. The Company reviews inventory to assess if there is obsolete or excess inventory and records a charge to cost of goods sold if and when applicable. Property and equipment Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years Impairment of long-lived assets The Company periodically evaluates long-lived assets for potential impairment in accordance with ASC 360, Property, Plant and Equipment . Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company recognized no impairment charges for the years ended December 31, 2022 and 2021, respectively. Business combinations The Company accounts for business combinations using the acquisition method of accounting in accordance with ASC 805, Business Combinations . Identifiable assets acquired and liabilities assumed are recorded at their acquisition date fair values. The excess of the fair value of purchase consideration over the fair values of the identifiable assets and liabilities is recorded as goodwill. Acquisition related costs are expensed as incurred. Upon acquisition, the accounts and results of operations are consolidated as of and subsequent to the acquisition date. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets. The Company utilizes commonly accepted valuation techniques, such as the income approach in establishing the fair value of intangible assets. See “Note 4 – Business combination” for additional detail. Goodwill The Company tests goodwill for impairment on an annual basis or whenever events occur that may indicate possible impairment. Goodwill is recorded as the difference, if any, between the aggregate consideration paid for an acquisition and the fair value of the net tangible and identified intangible assets acquired under a business combination. Goodwill is reviewed for impairment at a reporting unit level annually in the fourth quarter, or more frequently if events or circumstances indicate that the goodwill might be impaired. The Company first assesses qualitative factors to determine whether it is necessary to perform the quantitative goodwill impairment test. If, after assessing the totality of events or circumstances, the Company determines that it is not more likely than not that the fair value of the net assets is less than their carrying amount, then the quantitative goodwill impairment test is unnecessary. If, based on the qualitative assessment, it is determined that it is more likely than not that the fair value of the net assets is less than their carrying amount, then the Company proceeds to perform the quantitative goodwill impairment test. In connection with the annual impairment test conducted in the fourth quarter of 2022 and 2021, the Company performed a qualitative assessment in connection with the annual goodwill impairment evaluation and determined that it was more likely than not that the fair value of the net assets exceeded their carrying value. Intangible assets Acquired definite life intangible assets are amortized using the straight-line method over their respective estimated useful lives. The Company evaluates the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. The identified intangible assets are reviewed for impairment whenever events or changes in business circumstances arise that may indicate that the carrying amount of its intangible assets may not be recoverable. These events and changes can include significant current period operating losses or negative cash flows associated with the use of an intangible asset, or group of assets, combined with a history of such factors, significant changes in the manner of use of the assets, and current expectations that it is more likely than not that an intangible asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. When impairment indicators are present, the Company compares undiscounted future cash flows to the asset group’s carrying value to determine if the asset group is recoverable. If the carrying values are in excess of undiscounted expected future cash flows, the Company measures any impairment by comparing the fair value of the asset or asset group to its carrying value. No impairment expense was recorded for identified intangible assets during the year ended December 31, 2022 and 2021. For further discussion of identified intangible assets, see “Note 9 – Intangible assets”. Debt issuance costs Debt issuance costs incurred in connection with financing arrangements are amortized to interest expense over the life of the respective financing arrangement using the effective interest method. Debt issuance costs, net of related amortization, reduce the carrying value of the related debt. Contingent considerations The fair value of the Contingent Value Rights (“CVRs") is calculated by using a discounted cash flow method for the Keveyis patent milestone and an option pricing method for the Recorlev and Keveyis sales milestones. In the case of Keveyis milestones, the Company applies a scenario-based method and weights them based on the possible achievement of the milestone. This fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined in ASC 820, Fair Value Measurement . The key assumptions used include the discount rate and sales growth. The estimated value of the CVR consideration is based upon available information and certain assumptions which the Company's management believes are reasonable under the circumstances. The ultimate payout under the CVRs may differ materially from the assumptions used in determining the fair value of the CVR consideration. This value is then remeasured for future expected payout as well as the increase in fair value due to the time value of money. These gains or losses, if any, are recognized in the consolidated statements of operations and comprehensive loss. Deferred rent Certain of the Company’s lease agreements provide for scheduled rent increases during the lease term and also for abatement of some or all rental payments for a period of time after the occupancy date. In addition, certain of the Company’s lease agreements provide for tenant improvement allowances whereby the landlord funded the cost to build out the space. The Company records a liability for such lease incentives which is amortized to rent expense on a straight-line basis throughout the lease term. The Company adopted ASU 2016-02 on January 1, 2022 and the deferred rent balance was recorded as a reversal of right-of-use assets under the new standard. Warrant liability Warrants required to be settled in cash are accounted for as liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity. The fair value of these warrants are remeasured each reporting period using the Black-Scholes option-pricing model which considers the expected term of the warrants as well as the risk-free interest rate and expected volatility of the Company's common stock. The liability is recorded in other current liabilities on the consolidated balance sheets. Generally, changes in the fair value of the warrant liabilities are recorded in the consolidated statements of operations and comprehensive loss. Fair value of financial instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a non-recurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash, cash equivalents, restricted cash, accounts receivable, prepaid expenses and other current assets, and accounts payable, are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Amended and Restated Loan and Security Agreement approximates fair value due to the variable interest rate on the debt. Items measured at fair value on a recurring basis include the Company’s investments, warrants and CVRs. The fair value of the convertible senior notes is determined from using current interest rates based on credit ratings and the remaining term of maturity. Segment reporting Operating segments are identified as components of an enterprise for which separate discrete financial information is available and utilized by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company operates in one segment. New accounting pronouncements Adopted accounting standards In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) . This standard addresses issuers' accounting for certain modifications or exchanges of freestanding equity-classified written call options. This standard is effective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this standard in first quarter 2022 and it did not have a material impact on the financial statements. In October 2020, the FASB issued ASU 2020-10, Codification Improvements, to make incremental improvements to GAAP and address stakeholder suggestions, including, among other things, clarifying that the requirement to provide comparative information in the financial statements extends to the corresponding disclosures section. This standard will be effective for the Company for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted this standard as of the reporting period beginning January 1, 2022 and it did not have a material impact on the financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard eliminates certain exceptions in the current guidance related to the approach for intra-period tax allocation and the methodology for calculating income taxes in an interim period and amends other aspects of the guidance to help clarify and simplify United States GAAP. This standard is effective for the Company for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted this standard as of the reporting period beginning January 1, 2022 and it did not have a material impact on the financial statements. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to record a right-of-use ("ROU") asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases will be classified as either operating or finance leases under the new guidance. Operating leases will result in straight-line expense in the income statement, similar to current operating leases, and finance leases will result in more expense being recognized in the earlier years of the lease term, similar to current capital leases. This standard is effective for the Company for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. The FASB has extended the effective date of this standard for certain companies. As amended in ASU 2020-05, this standard will be effective for the Company for fiscal years beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted the new standard on January 1, 2022, using the modified retrospective approach by recognizing and measuring leases without revising comparative period information or disclosures. The Company elected the transition package of three practical expedients permitted within the standard, which among other things, allows for the carryforward of historical lease classifications. The Company made an accounting policy election to keep leases with terms of twelve months or less off the balance sheet and recognize those lease payments on a straight-line basis over the lease term. The Company recorded a $14.0 million lease liability equal to the present value of lease payments and a $6.3 million operating lease ROU asset, which is the corresponding lease liability adjusted for unamortized lease incentives. The impact of these changes at adoption had no impact on net income or shareholders’ equity. Prior periods were not restated under the new standard. See "Note 18 - Leases" for further details . The impact to the Company’s opening consolidated balance sheets as of January 1, 2022 was as follows (in thousands): As Reported Effect of Adopting Balance at December 31, 2021 ASC 842 January 1, 2022 Assets Right-of-use assets — 6,277 6,277 Other assets 829 (373) 456 Liabilities and stockholders’ equity Other accrued liabilities 49,088 (1,022) 48,066 Current operating lease liabilities — 1,028 1,028 Deferred rent 6,883 (6,883) — Other liabilities 1,676 (204) 1,472 Non-current operating lease liabilities — 12,985 12,985 Pending accounting standards In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This standard eliminates certain accounting models to simplify the accounting for convertible instruments, expands the disclosure requirements related to the terms and features of convertible instruments, and amends the guidance for the derivatives scope exception for contracts settled in an entity’s own equity. This standard enhances the consistency of earnings-per-share ("EPS") calculations by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted EPS calculations and disclosures. This standard is effective for the Company for fiscal years beginning after December 15, 2023. Early adoption is permitted but not earlier than periods beginning after December 15, 2020. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting . This standard provides optional expedients for application of GAAP, if certain criteria are met, to contracts and other transactions that reference London Inter-bank Offered Rate ("LIBOR") or other reference rates that are expected to be discontinued because of reference rate reform. This standard is effective for all entities as of March 12, 2020 through December 31, 2022. On December 21, 2022, the FASB issued ASU 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, which extends the period of time entities can utilize the reference rate reform relief guidance under ASU 2020-04 from December 31, 2022 to December 31, 2024. The Company does not currently expect the adoption of this new standard to have a material impact on the financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This standard requires entities to estimate an expected lifetime credit loss on financial assets ranging from short-term trade accounts receivable to long-term financings and report credit losses using an expected losses model rather than the incurred losses model that was previously used and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if the fair value increases. This standard would have been effective for the Company for fiscal years beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021. The effective date of ASC Topic 326 was then delayed until fiscal years beginning after December 15, 2022 for SEC filers that are eligible to be smaller reporting companies under the SEC’s definition, as well as private companies and not-for-profit entities. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements. |
Disaggregated revenue
Disaggregated revenue | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregated revenue | Disaggregated revenue The Company’s revenue is comprised primarily of sales of products and royalty revenue. Depending on the type of contract, the method of accounting and timing of revenue recognition may differ. Below is a description of the Company’s different types of revenue. • Product revenue - The Company sells product primarily to wholesalers or a specialty pharmacy who subsequently resell to retail pharmacies or patients. The Company enters into arrangements with payors, group purchasing organizations, and healthcare providers that provide for government-mandated or privately negotiated rebates, chargebacks and discounts related to the Company’s products. Revenue is recognized at the point in time when the Company's customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods or services, which is when the Company's obligations under the terms of the contract with the customer are satisfied, based on the consideration the Company expects to receive in exchange for those goods or services. • Royalty, contract and other revenue - Royalty and contract revenue is recognized as earned in accordance with contract terms when it can be reasonably estimated and collectability is reasonably assured. The disaggregated revenue by primary products is as follows: Years Ended December 31, 2022 2021 Product revenue (in thousands): Gvoke $ 52,527 $ 38,917 Keveyis 49,307 10,363 Recorlev 7,429 — Product revenue, net 109,263 49,280 Royalty, contract and other revenue 985 310 Total revenue $ 110,248 $ 49,590 |
Business combination
Business combination | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Business combination | Business combination On October 5, 2021 (the "acquisition closing date"), Xeris Pharma completed the acquisition of Strongbridge (the "Acquisition") pursuant to the Transaction Agreement, dated as of May 24, 2021, among Xeris Pharma, Strongbridge, Xeris Biopharma and Wells MergerSub, Inc. (the "Transaction Agreement"). Upon completion of the Acquisition, (a) the Company acquired Strongbridge by means of a scheme of arrangement (the "Scheme") under Irish law pursuant to which the Company acquired all of the outstanding ordinary shares of Strongbridge ("Strongbridge Shares") in exchange for (i) 0.7840 of a share of the Company’s common stock ("Company Shares") and cash in lieu of fractions of Company Shares in exchange for each Strongbridge Share held by such Strongbridge Shareholders and (ii) one (1) non-tradeable Contingent Value Right ("CVR"), worth up to a maximum of $1.00 per Strongbridge Share settleable in cash, additional Company Shares, or a combination of cash and additional Company Shares, at the Company’s sole election and (b) MergerSub merged with and into Xeris Pharma, with Xeris Pharma, as the surviving corporation in the merger (the “Merger,” and the Merger together with the Acquisition, the "Transactions"). Upon completion of the Merger, (a) each share of Xeris Pharma common stock was assumed by the Company and converted into the right to receive one Company Share and any cash in lieu of fractional entitlements due to a Xeris Pharma shareholder and (b) each Xeris Pharma option, stock appreciation right, restricted share award and other Xeris Pharma share based award that was outstanding was assumed by the Company and converted into an equivalent equity award of the Company, which award was subject to the same number of shares and the same terms and conditions as were applicable to the Xeris Pharma award in respect of which it was issued. On October 6, 2021, the Company’s common stock, par value $0.0001 per share, commenced trading on the Nasdaq Global Select Market ("Nasdaq") under the ticker symbol "XERS". See "Note 16 – Stock compensation plans" for a more detailed description of the equity award plans assumed in the Transactions. See "Note 13 – Warrants" for a more detailed description of the warrants assumed in the Transactions. The Acquisition was accounted for as a business combination using the acquisition method of accounting under the provisions of ASC 805, Business Combinations . The Acquisition has and will continue to diversify and increase the Company’s revenue base into the specialized commercial platforms and expand the development pipeline. Additionally, the Company has achieved significant synergies by eliminating redundant processes and reducing headcount, most notably within the commercial, executive and general and administrative functions. Acquisition consideration The acquisition-date fair value of the consideration transferred totaled $169.1 million, which consisted of the following: Fair value of consideration transferred (in thousands, except share number) Xeris Biopharma Holdings, Inc. common shares (58,082,606 shares) $ 137,655 Unexercised Strongbridge options assumed by Xeris Pharma and converted into options to purchase Company Shares 6,404 Strongbridge warrants 2,467 Contingent consideration (Contingent value rights) 22,531 Total consideration $ 169,057 The fair value of the common stock issued was determined based on the closing market price of shares of the Company’s common stock on the acquisition date. There were no changes to the purchase price allocation in 2022 and the measurement period closed on June 30, 2022. The fair value of the equity accounting warrants, which were assumed by the Company in connection with the Transactions, was determined using the Black-Scholes valuation model, which considers the expected terms of the warrants from the acquisition closing date as well as the risk-free interest rate, new exercise price after the 0.7840 conversion rate multiplied by and a volatility of 89.63% (a weighting of 60% of Xeris volatility and 40% of Strongbridge volatility is used). The fair value of the private placement warrants which were assumed by the Company in connection with the Transactions, was determined using the Black-Scholes valuation model which considers the expected terms of the private placement warrants from the acquisition closing date as well as the risk-free interest rate, current exercise price of $2.50 multiplied by (the average of Xeris Pharma closing prices for the 20-day period ending three three The CVRs represent contingent additional consideration of up to $1.00 for each CVR, payable to CVR holders, to satisfy future performance milestones, settleable in cash, common stock, or a combination of cash and common stock, at the Company's sole election. The CVRs are conditioned upon the achievement of the following: • Keveyis Milestone: $0.25 per CVR, upon the earlier of the first listing of any patent in the FDA's Orange Book for Keveyis by the end of 2023 or the first achievement of at least $40 million in net revenue of Keveyis in 2023; • 2023 Recorlev Milestone: $0.25 per CVR, upon the first achievement of at least $40 million in net revenue of Recorlev in 2023; and • 2024 Recorlev Milestone: $0.50 per CVR, upon the first achievement of at least $80 million in net revenue of Recorlev in 2024. Refer to "Note 14 - Fair Value Measurements", for information related to the fair value measurements on CVRs and valuation methods utilized. As of the acquisition closing date, there were approximately 74.1 million CVRs. There will be additional issuances of up to 10.5 million CVRs to holders of Strongbridge rollover options and assumed warrants upon exercise. Purchase price allocation In accordance with ASC 805, Xeris Pharma was determined to be the accounting acquirer in the Acquisition. The Company has applied the acquisition method of accounting that requires, among other things, that identifiable assets acquired and liabilities assumed generally be recognized on the balance sheet at fair value as of the acquisition date. In determining the fair value, the Company utilized various forms of the income, cost and market approaches depending on the asset or liability being fair valued. The estimation of fair value required significant judgment related to future net cash flows (including revenue, operating expenses, and working capital), discount rates reflecting the risk inherent in each cash flow stream, competitive trends, market comparables and other factors. Inputs were generally determined by taking into account historical data (supplemented by current and anticipated market conditions), trends and growth rates. The table below presents the estimated fair value that was allocated to Strongbridge’s assets and liabilities based upon fair values as determined by the Company (in thousands): Fair Value Cash and cash equivalents $ 38,469 Trade accounts receivable 4,344 Inventory 1,862 Prepaid expenses and other current assets 4,683 Property and equipment 161 IPR&D 121,000 Other intangible asset 11,000 Other assets 860 Total identifiable assets acquired 182,379 Accounts payable (279) Other accrued liabilities (13,703) Accrued trade discounts and rebates (4,844) Supply agreement liability (12,000) Deferred tax liabilities (4,942) Other liabilities (413) Total liabilities assumed (36,181) Net identifiable assets acquired 146,198 Goodwill 22,859 Net assets acquired $ 169,057 There were no changes to the purchase price allocation in 2022 and the measurement period closed on June 30, 2022. The following is a description of the methods used to determine the fair values of significant assets and liabilities. In-process research and development ("IPR&D") and other intangible asset The IPR&D intangible asset represents the recording of the acquired IPR&D indefinite-lived intangible asset related to Recorlev. The other intangible asset represents the commercial product in the form of Keveyis. The fair value for the IPR&D and other intangible assets were based on assumptions developed by management and other information compiled by management including, but not limited to, discounted future expected cash flows. The fair value of intangibles relies heavily on projected future net cash flows including, but not limited to, key assumptions for revenue and operating expenses. The discount rates used for intangible assets are based on current market rates and reflect the risk inherent in each cash flow stream. The estimated useful life of the intangible asset of Keveyis is five years which reflects the time period in which the Company expects to receive the benefits of the related cash flows. Goodwill The excess of the consideration transferred over the fair value of assets acquired and liabilities assumed was recognized as goodwill. Goodwill is generated from operational synergies and cost savings the Company expects to achieve from the combined operations and Strongbridge’s knowledgeable and experienced workforce. The majority of the goodwill is not expected to be deductible for tax purposes. Transaction costs In connection with the Transactions, the Company incurred significant expenses in 2021, including transaction costs (e.g., bankers' fees, legal fees, consultant fees, etc.). Such transaction costs totaled $8.6 million and were fully recorded in the selling, general and administrative expenses in 2021 through the first half of 2022. Supplemental pro forma information The following unaudited supplemental pro forma financial information assumes the companies were combined as of January 1, 2020. The pro forma financial information as presented below is for informational purposes only and is based on estimates and assumptions that have been made solely for purposes of developing such pro forma information. This is not necessarily indicative of the results of operations that would have been achieved if the Acquisition had taken place on January 1, 2020, nor is it necessarily indicative of future results. Consequently, actual results could differ materially from the unaudited pro forma financial information presented below. The following table presents the pro forma operating results as if Strongbridge had been included in the Company's consolidated statements of operations and comprehensive loss as of January 1, 2020 (unaudited, in thousands): Years Ended December 31, 2022 2021 Revenue $ 110,248 $ 79,509 Net loss $ (94,660) $ (160,342) These amounts have been calculated after applying the Company’s accounting policies and adjusting the results of Xeris to reflect the additional depreciation and amortization that would have been charged assuming the fair value adjustments to intangible assets had been applied on January 1, 2020. The unaudited supplemental pro forma information above does not include any cost saving synergies from operating efficiencies. There is a tax impact on the pro forma adjustments due to deferred tax liabilities being greater than the deferred tax assets in Ireland. For the other non-Irish entities, there is no tax impact of the pro forma adjustments reflected as both companies are, and have been for some time, in net operating loss positions and have full valuation allowances against their net deferred tax assets on both a historical and pro forma basis. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory [Line Items] | |
Inventory Disclosure [Text Block] | Inventory The components of inventories consisted of the following (in thousands): December 31, 2022 December 31, 2021 Raw materials $ 7,410 $ 5,181 Work in process 11,367 7,442 Finished goods 5,958 5,495 Inventory $ 24,735 $ 18,118 Inventory reserves were $1.3 million and $1.0 million at December 31, 2022 and December 31, 2021, respectively. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property and equipment Property and equipment consisted of the following (in thousands): December 31, 2022 December 31, 2021 Lab equipment $ 3,841 $ 3,739 Furniture and fixtures 1,355 1,355 Computer equipment 474 307 Office equipment 8 28 Software 307 307 Leasehold improvements 5,065 5,026 Total property and equipment 11,050 10,762 Less: accumulated depreciation and amortization (5,534) (4,135) Property and equipment, net $ 5,516 $ 6,627 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible assets Identified intangible assets consisted of the following (in thousands): Life (Years) December 31, 2022 December 31, 2021 Gross assets Accumulated amortization Net Gross assets Accumulated amortization Net Definite-lived intangible asset - Keveyis 5 $ 11,000 $ (2,750) $ 8,250 $ 11,000 $ (550) $ 10,450 Definite-lived intangible asset - Recorlev 14 121,000 (8,643) 112,357 121,000 — 121,000 Total intangible assets $ 132,000 $ (11,393) $ 120,607 $ 132,000 $ (550) $ 131,450 Keveyis is the developed product rights obtained from Strongbridge's acquisition of the United States marketing rights to Keveyis (dichlorphenamide) from Taro Pharmaceuticals North America, Inc. ("Taro"). Recorlev was acquired as a result of the Acquisition and was approved by the FDA on December 30, 2021. The IPR&D asset was reclassified as a definite-lived intangible asset in 2021 and began being amortized on a straight-line basis over an estimated useful life of 14 years assigned based on the economic life and remaining patent life. As of December 31, 2022 and 2021, the Company reviewed the indicators for impairment and concluded that no impairment of its definite-lived intangible assets existed. As of December 31, 2022, expected amortization expense for intangible assets subject to amortization for the next five years is as follows (in thousands): 2023 $ 10,843 2024 10,843 2025 10,843 2026 10,293 2027 8,643 Thereafter 69,142 Total $ 120,607 |
Other Accrued Liabilities (Note
Other Accrued Liabilities (Notes) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses [Abstract] | |
Other Accrued Liabilities | Other accrued liabilities Other accrued liabilities consisted of the following (in thousands): December 31, 2022 December 31, 2021 Accrued employee costs $ 13,400 $ 19,638 Supply agreement - current portion 6,720 6,009 Accrued supply chain costs 562 595 Accrued marketing costs 2,593 3,237 Accrued research and development costs 1,411 1,998 Accrued restructuring charges 2,799 6,715 Accrued interest expense 4,656 1,413 Accrued Strongbridge transaction costs — 1,839 Accrued other costs 4,645 7,644 Other accrued liabilities $ 36,786 $ 49,088 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term debt Convertible Senior Notes In June 2020, Xeris Pharma completed a public offering of $86.3 million aggregate principal amount of Xeris Pharma's 5.00% Convertible Senior Notes due 2025 (the "Convertible Notes"), including $11.3 million pursuant to the underwriters' option to purchase additional notes, which was exercised in full in July 2020. Xeris Pharma incurred debt issuance costs of $5.1 million in connection with the issuance of the Convertible Notes. Xeris Pharma used $20.0 million and $4.2 million of the net proceeds from the sale to prepay a portion of the principal amount on the Term A Loan (as defined below) and the remaining amount of borrowings outstanding under the PPP Loan (as defined below), respectively. The Convertible Notes are governed by the terms of a base indenture for senior debt securities dated June 30, 2020 (the "Base Indenture"), between Xeris Pharma and U.S. Bank National Association, as trustee, as supplemented by the first supplemental indenture thereto dated June 30, 2020 (the "First Supplemental Indenture"), between U.S. Bank National Association, as trustee, and the second supplemental indenture thereto dated October 5, 2021 (the "Supplemental Indenture" and together with the Base Indenture and First Supplemental Indenture, the "Indenture"), among the Company, Xeris Pharma and U.S. Bank National Association, as trustee. The Convertible Notes bear cash interest at the rate of 5.00% per annum, payable semi-annually in arrears on January 15 and July 15 of each year, beginning on January 15, 2021, to holders of record at the close of business on the preceding January 1 and July 1, respectively. The Convertible Notes will mature on July 15, 2025, unless earlier converted or redeemed or repurchased by the Company. At any time before the close of business on the second scheduled trading day immediately before the maturity date, holders of Convertible Notes may convert their Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The conversion rate for the Convertible Notes will initially be 326.7974 shares of the Company’s common stock per $1,000 principal amount of Convertible Notes, which represents an initial conversion price of approximately $3.06 per share of common stock, and is subject to adjustment under the terms of the Convertible Notes. In the event of certain circumstances, the Company will increase the conversion rate, provided that the conversion rate will not exceed 367.6470 shares of the Company's common stock per $1,000 principal amount of Convertible Notes. In the second half of 2020, $8.4 million in principal amount of Convertible Notes were converted into 2,736,591 shares of Xeris Pharma’s common stock at the conversion rate of 326.7974 shares per $1,000 principal amount of Convertible Notes. Additionally, in the fourth quarter of 2020, Xeris Pharma entered into separate, privately negotiated exchange agreements with certain holders of Convertible Notes to exchange $30.7 million in principal amount of Convertible Notes for 10,435,200 shares of Xeris Pharma’s common stock. Xeris Pharma recognized a $2.6 million loss related to the convertible note exchange transactions. The Convertible Notes are senior, unsecured obligations and are equal in right of payment with Xeris Pharma's existing and future senior, unsecured indebtedness, senior in right of payment to its future indebtedness, if any, that is expressly subordinated to the Convertible Notes, and effectively subordinated to its existing and future secured indebtedness to the extent of the value of the collateral securing that indebtedness. The Convertible Notes are structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables, and (to the extent Xeris Pharma is not a holder thereof) preferred equity, if any, of the Company’s other direct and indirect subsidiaries. As a result of the Transactions, and pursuant to the Second Supplemental Indenture, the Convertible Notes are no longer convertible into shares of common stock of Xeris Pharma common stock. Instead, subject to the terms and conditions of the Indenture, the Convertible Notes will be exchangeable into cash and shares of common stock of the Company in proportion to the transaction consideration payable pursuant to the Transaction Agreement, and the "Reference Property" provisions in the Indenture. Pursuant to the Second Supplemental Indenture, the Company agreed to guarantee (a) the full and punctual payment when due of all monetary obligations of Xeris Pharma under the Indenture and (b) the full and punctual performance within applicable grace periods of all other obligations of Xeris Pharma under the Indenture. The fair value of the convertible senior notes is determined from using current interest rates based on credit ratings and the remaining term of maturity. As of December 31, 2022, the fair value of the convertible senior notes was approximately $40.5 million. Loan Agreement In September 2019, Xeris Pharma entered into an Amended and Restated Loan and Security Agreement (the "Amended Loan Agreement") with Oxford Finance LLC ("Oxford"), as the collateral agent (in such capacity, the "Collateral Agent") and a lender, and Silicon Valley Bank, as a lender ("SVB", and together with Oxford, the "Prior Lenders"), which amended and restated that certain Loan and Security Agreement dated February 28, 2018 with the Prior Lenders in its entirety. The Amended Loan Agreement provided for the Prior Lenders to extend up to $85.0 million in term loans to Xeris Pharma in three tranches, of which $60.0 million was drawn down in September 2019. In March 2022, the Company, Xeris Pharma and certain subsidiary guarantors of the Company entered into a Credit Agreement and Guaranty (the "Hayfin Loan Agreement") with the lenders from time to time parties thereto (the "Lenders") and Hayfin Services LLP, as administrative agent for the Lenders (in such capacity, together with its successors and assigns, the "Agent"), pursuant to which the Company and its subsidiaries party thereto granted a first priority security interest on substantially all of their assets, including intellectual property, subject to certain exceptions. The Hayfin Loan Agreement provided for the Lenders to extend $100.0 million in term loans to the Company on the closing date and up to an additional $50.0 million in delayed draw term loans during the one year period immediately following the closing date (collectively, the "Loans"). On December 28, 2022, the Company borrowed the full amount of such $50.0 million delayed draw term loan under the Hayfin Loan Agreement. In conjunction with the execution of the Hayfin Loan Agreement, the Amended Loan Agreement balance of $43.5 million was repaid in full and fees of $2.1 million in connection with the loan repayment were paid. In addition to utilizing the proceeds to repay the obligations under the Amended Loan Agreement in full, the proceeds will otherwise be used for general corporate purposes. After repayment, the Loans may not be re-borrowed. All of the Loans incur interest at a floating per annum rate in an amount equal to the sum of (i) 9.0% (or 8.0% per annum if the replacement rate in effect is the Wall Street Journal Prime Rate) plus (ii) the greater of (x) (1) CME Group Benchmark Administration Limited (CBA) Term SOFR (or the replacement rate, if applicable) if CBA Term SOFR is greater than 1.00% plus 0.26161% or (2) 1.00% if CME Term SOFR is less than 1.00% and (y) one percent (1.00%) per annum (or 2.0% per annum if the replacement rate in effect is the Wall Street Journal Prime Rate). Following the borrowing of the delayed draw term loans in December 2022, the Company has incurred total debt issuance costs of approximately $3.6 million related to the Hayfin Loan Agreement, which are being amortized to interest expense over the life of the loan using the effective interest method. The remaining balance of unamortized debt issuance costs have been reflected as a direct reduction to the loan balance. The effective interest rate, including the amortization of debt discount and debt issuance costs, amounts to 11.8%, maturing March 2027. The debt outstanding under the Hayfin Loan Agreement approximates fair value due to the variable interest rate on the debt. The Loans will mature on March 8, 2027; provided, however, that the Loans will mature on January 15, 2025 if the Convertible Notes are still outstanding as of such date and either (i) the maturity date thereof has not been extended to a date on or after September 4, 2027 or (ii) the Company has not received net cash proceeds from one or more permitted equity raises or permitted raises of convertible debt which, together with no more than $15.0 million of cash on hand, is sufficient to redeem and discharge the Convertible Notes in full. The Hayfin Loan Agreement allows the Company to voluntarily prepay the outstanding amounts thereunder. The Company is subject to an early prepayment fee equal to (i) for any prepayment that occurs prior to the second anniversary of the closing date, the applicable make-whole amount, (ii) for any prepayment that occurs after the second anniversary of the closing date but on or prior to the fourth anniversary of the closing date: (x) the amount of any principal so prepaid, multiplied by (y) for any prepayment that occurs (A) after the second anniversary of the closing date and on or prior to the third anniversary of the closing date, five percent (5.0%), (B) after the third anniversary of the closing date and on or prior to the fourth anniversary of the closing date, three percent (3.0%), and (C) after the fourth anniversary of the closing date, zero percent (0.0%). The Hayfin Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to incur additional indebtedness, grant liens, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case subject to certain exceptions. Associated with the Hayfin Loan Agreement, the Lenders also received warrants to purchase 1,315,789 shares of the common stock of the Company at a price of $2.28 per share. Refer to "Note 13 - Warrants" for further information on the warrants. On September 29, 2022, the Company entered into Amendment No. 1 to Credit Agreement and Guaranty ("Amendment No. 1") with Xeris Pharma, the Lenders parties thereto and the Agent, to amend the Hayfin Loan Agreement. Amendment No. 1 provides for the Lenders’ consent to and allows for the issuance of the letter of credit that was issued to the landlord under the Amended and Restated Lease dated September 29, 2022 between Xeris Pharma and Fulton Ogden Venture, LLC, as the landlord, for the premises located at 1375 West Fulton Street in Chicago. The components of debt are as follows (in thousands): December 31, 2022 December 31, 2021 Convertible Notes $ 47,175 $ 47,175 Loan facility 144,487 43,500 Less: unamortized debt issuance costs (4,587) (2,608) Long-term debt, net of unamortized debt issuance costs $ 187,075 $ 88,067 The following table sets forth the Company’s future minimum principal payments on the Convertible Note and the loan facility (in thousands): 2023 $ — 2024 — 2025 47,175 2026 — 2027 150,000 $ 197,175 |
Stockholders' equity
Stockholders' equity | 12 Months Ended |
Dec. 31, 2022 | |
Reverse Stock Split and Initial Public Offering [Abstract] | |
Stockholders' equity | Stockholders' equity The Company’s 375.0 million authorized shares of stock are divided into 350.0 million shares of common stock, par value $0.0001 per share, and 25.0 million shares of undesignated preferred stock, par value $0.0001 per share. At December 31, 2022, none of the 25.0 million shares of preferred stock were outstanding, and the Company has no present plans to issue any shares of preferred stock. The Company’s board of directors has the authority, without action by the Company’s stockholders, to designate and issue the preferred stock in one or more series and to designate the rights, preferences, limitations and privileges of each series of preferred stock, which may be greater than the rights of the Company’s common stock. The Company has not paid any cash dividends on the common stock during the periods presented. In March 2021, the Company completed a registered direct offering of 6,553,398 shares of the common stock at a price of $4.12 per share. Net proceeds from the equity offering were approximately $26.9 million after deducting offering expenses. On October 5, 2021, the Company completed the acquisition of Strongbridge. Upon completion of the Merger, (a) each share of Xeris Pharma common stock was assumed by the Company and converted into the right to receive one Company Share and any cash in lieu of fractional entitlements due to a Xeris Pharma shareholder and (b) each Xeris Pharma option, stock appreciation right, restricted share award and other Xeris Pharma share based award that was outstanding was assumed by the Company and converted into an equivalent equity award of the Company, which award was subject to the same number of shares and the same terms and conditions as were applicable to the Xeris Pharma award in respect of which it was issued. Upon completion of the Merger, the Company acquired all of the outstanding Strongbridge Shares in exchange for (i) 0.7840 of a share of the Company Shares and cash in lieu of fractions of Company Shares in exchange for each Strongbridge Share held by such Strongbridge Shareholders and (ii) one CVR. Strongbridge’s outstanding equity awards were treated as set forth in the Transaction Agreement, such that (i) each Strongbridge Share Award was vested and settled for Strongbridge Shares immediately prior to the effective time of the Scheme, (ii) each Strongbridge Option became fully vested and exercisable immediately prior to the effective time of the Scheme, (iii) each unexercised Strongbridge Option was assumed by the Company and converted into an option to purchase Company Shares. On January 3, 2022, the Company entered into a securities purchase agreement in connection with a private placement with an affiliate of Armistice Capital, LLC (“Armistice”) for aggregate gross proceeds of approximately $30.0 million. In accordance with the purchase agreement, the Company issued to Armistice an aggregate of (i) 10,238,908 shares of the Company’s common stock, par value $0.0001 per share at a purchase price of $2.93 per share, and (ii) warrants to purchase an aggregate of 5,119,454 shares of the Company's common stock at an exercise price of $3.223 per share. The warrants became exercisable immediately upon the closing of the transaction and have a term of five years from the earliest of the date (a) of effectiveness of the resale registration statement, which was February 7, 2022, (b) all of the shares and the Company's common stock issuable upon exercise of the warrants (the "Warrant Shares") have been sold pursuant to Rule 144 or may be sold pursuant to Rule 144 without the requirement for the Company to be in compliance with the current public information required under Rule 144 and without volume or manner-of-sale restrictions, (c) following the one-year anniversary of the date of closing provided that the holder of Shares or Warrant Shares is not an affiliate of the Company, or (d) all of the shares and Warrant Shares may be sold pursuant to an exemption from registration under Section 4(a)(1) of the Securities Act without volume or manner-of-sale restrictions. |
Warrants (Notes)
Warrants (Notes) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants [Abstract] | |
Other Liabilities Disclosure | Warrants On completion of the Strongbridge Acquisition, (a) each outstanding and unexercised Strongbridge warrant (except private placement warrants) was assumed by the Company such that, upon exercise, the applicable holders will have the right to have delivered to them the reference property (as such term is defined in the Strongbridge assumed warrants) and (b) each outstanding and unexercised Strongbridge private placement warrant was assumed by the Company such that the applicable holders will have the right to subscribe for Company Shares, in accordance with certain terms of the Strongbridge private placement warrants. The assumed Strongbridge private placement warrants expired in June 2022. Associated with the Armistice securities purchase agreement disclosed in "Note 15 - Stockholders' equity", the Company also issued warrants (the "Armistice Warrants") to purchase an aggregate of 5,119,454 shares of the Company's common stock at an exercise price of $3.223 per share. The warrants became exercisable immediately upon the closing of the transaction and have a term of five years from the earliest of the date (a) of effectiveness of the resale registration statement, which was February 7, 2022, (b) all of the shares of the Company’s common stock issued or issuable to Armistice under the securities purchase agreement and all shares of the Company's common stock issuable upon exercise of the warrants (the "Warrant Shares") have been sold pursuant to Rule 144 or may be sold pursuant to Rule 144 without the requirement for the Company to be in compliance with the current public information required under Rule 144 and without volume or manner-of-sale restrictions, (c) following the one-year anniversary of the date of closing provided that the holder of Shares or Warrant Shares is not an affiliate of the Company, or (d) all of the shares and Warrant Shares may be sold pursuant to an exemption from registration under Section 4(a)(1) of the Securities Act without volume or manner-of-sale restrictions. Associated with the Hayfin Loan Agreement disclosed in "Note 12 - Long-term debt", the Lenders also received warrants to purchase 1,315,789 shares of the common stock of the Company at a price of $2.28 per share. The warrants are (i) exercisable until the seventh (7th) anniversary of the closing date; (ii) freely transferable and detachable from the Loans; and (iii) subject to customary warrant holder rights and protections, including structural-based anti-dilution protection and adjustments for stock dividends, splits, combinations, reclassifications and the like. As of December 31, 2022, the following warrants were outstanding: Warrants classified as liabilities: Outstanding Warrants Exercise Price per Warrant Expiration Date 2018 Term A Warrants 53,720 $11.169 February 2025 2018 Term B Warrants 40,292 $11.169 September 2025 94,012 Warrants classified as equities: Warrants in connection with CRG loan agreement 309,122 $9.410 July 2024 Warrants in connection with CRG loan amendment in January 2018 978,628 $12.760 January 2025 Warrants in connection with Avenue Capital loan agreement 209,633 $2.390 May 2025 Warrants in connection with Avenue Capital loan agreement 209,633 $2.390 December 2025 Warrants in connection with Horizon and Oxford loan agreement 125,999 $3.130 December 2026 Warrants in connection with Armistice securities purchase agreement 5,119,454 $3.223 February 2027 Warrants in connection with Hayfin loan agreement 1,315,789 $2.280 March 2029 8,268,258 The Company recognized gains of $49,000 and $35,000 upon the change in fair value of the warrants during the year ended December 31, 2022 related to the 2018 Term A Warrants and the 2018 Term B Warrants, respectively. The Company recognized gains of $1.7 million related to the change in fair value and the expiration of the assumed Strongbridge private placement warrants in June 2022. The Company recognized gains (losses) of $(768,000), $39,000 and $27,000 upon the change in fair value of the warrants during the year ended December 31, 2021 related to the assumed Strongbridge private placement warrants, the 2018 Term A Warrants and the 2018 Term B Warrants, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and contingencies Commitments Commitments to Taro Upon the completion of Strongbridge acquisition, the Company also acquired the supply agreement Strongbridge had with Taro to produce Keveyis. Strongbridge was obligated to purchase annual minimum amounts of product totaling approximately $29.1 million over a six-year period from Taro. As of December 31, 2022, the remaining obligation under the Supply Agreement was $8.0 million. The term of the agreement with Taro was renewed for an additional two years beyond the termination of the orphan exclusivity period. If Taro declines to renew the agreement during the next renewal period, the Company has the right to manufacture the product on its own or have the product manufactured by a third party on its behalf. The Company is also required to reimburse Taro for a royalty obligation resulting from its sale of Keveyis to the Company. As of December 31, 2022, the Company had unused letters of credit of $4.3 million, which were issued primarily to secure leases. These letters of credit are collateralized by $4.3 million of restricted cash, which is recorded in other assets in the consolidated balance sheets. Leases We have obligations under operating leases for office and laboratory spaces. For a description of the Company's leases, please see "Note 18 - Leases". Contingencies CVR liability Upon closing the Transactions, the Company entered into a CVR Agreement. Each CVR entitles its holder to receive additional consideration of up to $1.00, to satisfy future performance milestones, settleable in cash, common stock, or a combination of cash and common stock, at the Company's sole election. As of the acquisition closing date, there were approximately 74.1 million CVRs. There will be additional issuances of up to 10.5 million CVRs to holders of Strongbridge rollover options and assumed warrants upon exercise. Litigation From time to time, the Company may become involved in various legal actions arising in the ordinary course of business. As of December 31, 2022, management was not aware of any existing, pending or threatened legal actions that would have a material impact on the financial position or results of operations of the Company. Long Term Debt In the event the Convertible Notes are still outstanding as of January 15, 2025 and the maturity date thereof has not been extended to a date on or after September 4, 2027, then unless the Company has received net cash proceeds from one or more permitted equity raises or permitted raises of convertible debt which, together with no more than $15.0 million of cash on hand, is sufficient to redeem and discharge the Convertible Notes in full, the loans outstanding under the Hayfin Loan Agreement will mature on January 15, 2025. |
Restructuring costs
Restructuring costs | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring costs | Restructuring costs After the completion of the Acquisition on October 5, 2021, the Company undertook a strategic restructuring to streamline the organization and realize operating expense synergies. The costs associated with the restructuring include employee termination costs. The Company incurred total restructuring costs of approximately $11.1 million related to this plan, which has been fully recorded through 2022. Costs of $1.5 million were incurred in the year ended December 31, 2022, with the majority incurred in the first quarter of 2022. The majority of the restructuring costs are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. The Company anticipates the restructuring related to the Strongbridge acquisition to be complete by the fourth quarter of 2023. The restructuring reserve is included in other accrued liabilities in the consolidated balance sheets. The following table summarizes the initial restructuring reserve in connection with the Strongbridge acquisition and the payments made during the years ended December 31, 2022 and 2021 (in thousands): Restructuring Costs Restructuring costs $ 9,657 Payments (2,944) Balance accrued at December 31, 2021 $ 6,713 Restructuring costs $ 1,488 Payments (5,402) Balance accrued at December 31, 2022 $ 2,799 |
Stock Compensation Plan (Notes)
Stock Compensation Plan (Notes) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock Compensation Plan | Stock compensation plan In 2011, the Company adopted the 2011 Stock Option Issuance Plan (the "2011 Plan") and subsequently amended it to authorize the Board of Directors to issue up to 4,714,982 incentive stock option and non-qualified stock option awards. The 2018 Stock Option and Incentive Plan (the "2018 Plan") was adopted by the Board of Directors in April 2018 and approved by the Company's stockholders in June 2018 to award up to 1,822,000 shares of common stock. This plan became effective on the date immediately prior to the effectiveness of the Company's IPO registration statement. The 2018 Plan replaced the 2011 Plan as the Board of Directors decided not to make additional awards under the 2011 Plan following the closing of the IPO, which occurred in June 2018. The 2018 Plan allows the compensation committee to make equity-based and cash-based incentive awards to the Company's officers, employees, directors and other key persons (including consultants). No grants of stock options or other awards may be made under the 2018 Plan after the tenth anniversary of the effective date. The 2018 Plan provides that the number of shares reserved and available for issuance under the plan will automatically increase each January 1, beginning on January 1, 2019, and each January 1 thereafter, by 4% of the outstanding number of shares of the Company's common stock on the immediately preceding December 31, or such lesser number of shares as determined by the compensation committee. This number is subject to adjustment in the event of a stock split, stock dividend or other change affecting the Company's common stock. On January 1, 2022 and 2021, the number of shares of common stock available for issuance under the 2018 Plan was automatically increased by 4,994,933 shares and 2,384,448 shares, respectively. As of December 31, 2022, there were 3,380,363 shares of common stock available for future issuance under the 2018 Plan. The 2018 Employee Stock Purchase Plan (the "ESPP") was adopted by the Board of Directors in April 2018 and approved by the Company's stockholders in June 2018 to issue up to 193,000 shares of common stock to participating employees. Through the ESPP, eligible employees may authorize payroll deductions of up to 15% of their compensation to purchase up to the number of shares of common stock determined by dividing $25,000 by the closing market price of Xeris common stock on the offering date. The purchase price per share at each purchase date is equal to 85% of the lower of (i) the closing market price per share of Xeris common stock on the employee’s offering date or (ii) the closing market price per share of Xeris common stock on the purchase date. Each offering period has a six-month duration and purchase interval with a purchase date of the last business day of June and December each year. This plan became effective on the date immediately prior to the effectiveness of the Company's IPO registration statement. The ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2019 and each January 1 thereafter through January 1, 2028, by the least of (i) 1% of the outstanding number of shares of our common stock on the immediately preceding December 31; (ii) 386,000 shares or (iii) such lesser number of shares as determined by the ESPP administrator. On January 1, 2022 and 2021, the number of shares of common stock available for issuance under the ESPP increased by 386,000 shares and 386,000 shares, respectively. The number of shares reserved under the ESPP is subject to adjustment in the event of a stock split, stock dividend or other change affecting the Company's common stock. The Company issued 671,867 shares at a weighted average price of $1.45 per share during the year ended December 31, 2022. As of December 31, 2022, there were 191,860 shares available for issuance under the ESPP. The Equity Inducement Plan (the "Inducement Plan") was adopted by the Board of Directors in February 2019. The Inducement Plan was adopted without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan allows the Company to make stock option or restricted stock unit awards to prospective employees of the Company as an inducement to such individuals to commence employment with the Company. The Company uses this Inducement Plan to help it attract and retain prospective employees who are necessary to support the commercialization of products and the expansion of the Company generally. The Company initially reserved 750,000 shares of common stock for the issuance of awards under the Inducement Plan. This number is subject to adjustment in the event of a stock split, stock dividend or other change affecting the Company's common stock. As of December 31, 2022, there were 305,349 shares of common stock available for future issuance under the Inducement Plan. Assumed Plans At the effective time of the Scheme, Strongbridge’s outstanding equity awards were treated as set forth in the Transaction Agreement, such that (i) each award (other than options to buy shares, each a "Strongbridge Share Award") denominated in Strongbridge Shares was vested and settled for Strongbridge Shares immediately prior to the effective time of the Scheme, (ii) each Strongbridge Option became fully vested and exercisable immediately prior to the effective time of the Scheme, (iii) each unexercised Strongbridge Option was assumed by the Company and converted into an option to purchase Company shares (each, a "Strongbridge Rollover Option"), with the exercise price per Company share and the number of Company shares underlying the Strongbridge Rollover Option adjusted to reflect the conversion from Strongbridge Shares into Company shares, provided that each Strongbridge Rollover Option will continue to have, and be subject to, the same terms and conditions that applied to the corresponding Strongbridge Rollover Option (except for terms rendered inoperative by reason of the Acquisition or for immaterial administrative or ministerial changes that are not adverse to any holder other than in any de minimis respect), provided that the terms of each Strongbridge Rollover Option with an exercise price of $4.50 or less (prior to the adjustment described above) were amended to provide that it shall remain exercisable for a period of time following the effective time of the Scheme equal to the lesser of (A) the maximum remaining term of such corresponding Strongbridge Option and (B) the fourth anniversary of the effective date of the Merger, in each case regardless of whether the holder of such Strongbridge Rollover Option experiences a termination of employment or service on or following the effective time of the Scheme. On the acquisition closing date, the Company assumed all then-outstanding stock options and shares available and reserved for issuance under some legacy equity incentive plans of Strongbridge, including the Strongbridge 2015 equity compensation plan and Strongbridge 2017 inducement plan (collectively, the "Assumed Plans"). Shares reserved under the Assumed Plans will be available for future grants. The Company also assumed all then-outstanding stock options from the rest of the legacy equity incentive plans of Strongbridge without assuming the shares available and reserved for issuance under these plans. The number of shares subject to stock options outstanding under all Strongbridge legacy equity incentive plans are included in the tables below. As of December 31, 2022, there were 3,674,889 shares reserved for future grants under the Assumed Plans. CVRs were also issued to the holders of Strongbridge vested and unexercised options that were outstanding and assumed by the Company at the acquisition date, provided that in no event shall such holder be entitled to any payments with respect to such CVR unless the corresponding option has been exercised on or prior to any such payment. Stock options Stock options are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Stock option awards typically vest over either two three seven The fair value of each option is estimated on the date of grant using a Black-Scholes option valuation model that uses the assumptions noted in the following table. The expected term of options represents the period of time that options granted are expected to be outstanding. The risk-free interest rate for periods during the contractual life of the option is based on the United States Treasury yield curve in effect at the time of grant. The expected stock price volatility assumption is based on the historical volatilities of a peer group of publicly traded companies as well as the historical volatility of the Company's common stock since the Company began trading subsequent to the IPO in June 2018 over the period corresponding to the expected life as of the grant date. The expected dividend yield is based on the expected annual dividend as a percentage of the market value of the Company’s ordinary shares as of the grant date. The fair value of stock options granted was estimated with the following weighted average assumptions: Years Ended December 31, 2022 2021 Expected term (years) 5.5 6.0 Risk-free interest rate 3.01% 1.15% Expected volatility 80.18% 76.34% Expected dividends — — Stock option activity under the 2011 Plan, 2018 Plan, Inducement Plan and Assumed Plans for the year ended December 31, 2022 was as follows: Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Outstanding - December 31, 2021 11,362,336 $ 5.86 5.62 Granted 175,000 2.10 Exercised (11,228) 0.69 Forfeited (87,680) 5.25 Expired (1,738,267) 8.31 Outstanding - December 31, 2022 9,700,161 $ 5.37 4.76 Exercisable - December 31, 2022 9,032,882 $ 5.44 4.51 Vested and expected to vest at December 31, 2022 9,700,161 $ 5.37 4.76 The weighted average fair value of awards granted during the year ended December 31, 2022 was $1.43 per share. At December 31, 2022, there was a total of $1.7 million of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 1.4 years. Restricted Stock Units The Company grants Restricted Stock Units ("RSU"s) to employees. RSUs that are granted vest over either three A summary of outstanding RSU awards and the activity for the year ended December 31, 2022 was as follows: Number of Units Weighted Average Grant Date Fair Value Unvested balance - December 31, 2021 2,005,041 $ 5.15 Granted 4,477,850 2.71 Vested (708,970) 5.46 Forfeited (518,361) 2.90 Unvested balance - December 31, 2022 5,255,560 $ 3.25 As of December 31, 2022, there was $10.3 million of unrecognized stock-based compensation expense related to RSUs, which is expected to be recognized over the weighted-average remaining vesting period of 1.8 years. Employee Stock Purchase Plan The fair value of the ESPP Plan shares was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions: Years Ended December 31, 2022 2021 Expected term (years) 0.5 0.5 Risk-free interest rate 1.18 % 0.08 % Expected volatility 79.50 % 77.40 % Expected dividends — — The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, RSUs and the ESPP (in thousands): Years Ended December 31, 2022 2021 Cost of goods sold $ — $ 106 Research and development 1,593 1,696 Selling, general and administrative 10,567 9,579 Total stock-based compensation expense $ 12,160 $ 11,381 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company has non-cancellable operating leases for office and laboratory space, which expire at various times in 2031 and 2037. The non-cancellable lease agreements provide for monthly lease payments which increase during the term of each lease agreement. On September 29, 2022, Xeris Pharma entered into an Amended and Restated Lease (the “Lease”) with Fulton Ogden Venture, LLC (“Landlord”) whereby Xeris Pharma will lease approximately 87,032 square feet of office and laboratory space at 1375 West Fulton Street, Chicago, Illinois (the “Premises”), which Premises includes Xeris Pharma’s existing laboratory space. The term of the original lease commenced on January 1, 2021 as to Xeris Pharma’s existing space at 1375 West Fulton Street, and the Lease will commence on the later of the substantial completion of the Landlord’s improvement work and April 1, 2023 (“Expansion Commencement Date”) as to the expansion portion of the Premises, and for the entire Premises, the term will expire on the earlier of the last day of the One Hundred Fifty-Sixth (156 th ) full calendar month following the Expansion Commencement Date and March 31, 2037, unless extended or earlier terminated pursuant to the terms of the Lease. Xeris Pharma has the option to extend the term of the Lease for two successive five-year periods, subject to the terms and conditions of the Lease. In addition, the Lease contains customary default provisions, including, without limitation, those relating to payment default and bankruptcy events. The lease on the expansion portion of the Premises has not yet commenced but created significant rights and obligations for us. The estimated initial operating lease liability related to the expansion portion of the Premises is approximately $22.8 million and operating lease ROU asset is approximately $23.1 million upon commencement in 2023. Real estate leases often require that the Company pays maintenance, real estate taxes and insurance in addition to rent. These payments are generally variable and based on actual costs incurred by the lessor. Therefore, these amounts are not included in the consideration of the contract when determining the ROU asset and lease liability, but are reflected as variable lease expenses. All of the Company's leases are classified as operating leases, which are included as operating lease ROU assets and current and non-current operating lease liabilities in the consolidated balance sheets. The Company’s operating lease costs are included in operating expenses in the accompanying consolidated statements of operations and comprehensive loss. The Company's lease agreements do not contain any material residual value guarantees or material restrictive covenants. A majority of the Company's lease agreements include fixed rental payments. Certain of the lease agreements include fixed rental payments that are adjusted periodically by a fixed rate. The fixed payments, including the effects of changes in the fixed rate or amount, and renewal options reasonably certain to be exercised, are included in the measurement of the related lease liability. Most of the real estate leases include one or more options to renew, with renewal terms that can extend the lease term from one As the interest rate implicit in the lease is not readily determinable, the Company uses the incremental borrowing rate as the discount rate. The Company considers observable inputs as of the effective date of the ASC 842 adoption including the credit rating, existing borrowings and other relevant borrowing rates, such as risk-free rates like the United States Treasury rate, and then adjusting as necessary for the appropriate leas term. The incremental borrowing rate is reassessed if there is a change to the lease term or if a modification occurs and it is not accounted for as a separate contract. As of December 31, 2022, the Company’s operating leases had a weighted-average remaining lease term of 7.6 years and a weighted-average discount rate of 11.4%. Supplemental cash flow information related to the Company’s operating and finance leases was as follows (in thousands): Year Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $2,159 Right of use assets obtained in exchange for new lease obligations: Operating leases — The Company reports the amortization of operating lease ROU assets and the change in operating lease liabilities on a net basis in other in the operating activities of the accompanying consolidated statements of cash flows. The components of lease expense were as follows (in thousand): Lease cost Year Ended Operating lease expense 1,799 Variable lease cost 1,091 Sublease income (212) Total lease cost 2,678 As of December 31, 2022, maturities of lease liabilities are summarized as follows (in thousands): 2023 $ 1,586 2024 1,556 2025 1,820 2026 1,869 2027 1,918 Thereafter 10,674 Total lease payments 19,423 Less: Effect of discounting to net present value (8,441) Present value of lease liabilities $ 10,982 Operating lease liabilities, current 1,580 Operating lease liabilities, non-current 9,402 Total operating lease liabilities $ 10,982 Fiscal 2021 Activity Before Adoption of Topic 842 The Company leases office facilities under various noncancelable operating leases. Rental expense for operating leases was approximately $2.4 million for the year ended December 31, 2021. Under the previous lease accounting prior to the adoption of ASC 842, future minimum annual rental commitments for operating leases as of December 31, 2021 were as follows (in thousands): 2022 $ 1,813 2023 2,031 2024 1,981 2025 1,931 2026 1,982 Thereafter 11,741 Total minimum lease payments $ 21,479 |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are classified and disclosed in one of the following categories: Level 1: Measured using unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2: Measured using quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs, other than quoted prices in active markets, that are observable either directly or indirectly. Level 3: Measured based on prices or valuation models that require inputs that are both significant to the fair value measurement and less observable from objective sources (i.e., supported by little or no market activity). Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for the financial assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. The following tables present the Company’s fair value hierarchy for those assets and liabilities measured at fair value as of December 31, 2022 and December 31, 2021 (in thousands): Total as of December 31, 2022 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 121,966 $ 121,966 $ — $ — Liabilities Contingent value rights $ 25,688 $ — $ — $ 25,688 Warrant liabilities $ 9 $ — $ — $ 9 Total as of December 31, 2021 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 67,271 $ 67,271 $ — $ — Investments: Corporate securities 12,067 — 12,067 — Commercial paper 21,773 — 21,773 — Foreign government 1,322 — 1,322 — Total investments $ 35,162 $ — $ 35,162 $ — Liabilities Contingent value rights $ 22,531 $ — $ — $ 22,531 Warrant liabilities $ 1,769 $ — $ — $ 1,769 Contingent Value Rights Upon completion of the Merger described in "Note 4 – Business combination", the Company acquired all of the outstanding Strongbridge Shares in exchange for (i) 0.7840 of a share of the Company Shares and cash in lieu of fractions of Company Shares in exchange for each Strongbridge Share held by such Strongbridge Shareholders and (ii) one CVR. Strongbridge’s outstanding equity awards were treated as set forth in the Transaction Agreement, such that (i) each Strongbridge Share Award was vested and settled for Strongbridge Shares immediately prior to the effective time of the Scheme, (ii) each Strongbridge Option became fully vested and exercisable immediately prior to the effective time of the Scheme, (iii) each unexercised Strongbridge Option was assumed by the Company and converted into an option to purchase Company Shares. Contingent consideration obligations are recorded at their estimated fair values and these obligations are revalued each reporting period until the related contingencies are resolved. The CVRs are adjusted to fair value using the methods described above at the end of each reporting period. Significant changes which increase or decrease the probabilities of achieving the related milestones or shorten or lengthen the time required to achieve such events would result in corresponding increases or decreases in the fair values of these obligations. The Company has determined that the CVR liabilities' fair values are Level 3 items within the fair value hierarchy. The following table presents the change in the CVR liabilities (in thousands): Balance at the Acquisition $ 22,531 Change in fair value of CVRs — Balance at December 31, 2021 22,531 Change in fair value of CVRs 3,157 Balance at December 31, 2022 $ 25,688 Refer to "Note 19 – Commitments and contingencies" for additional information on the CVRs. Warrant liability The fair value of the Company’s warrant liabilities is based on a Black-Scholes valuation, which considers the expected term of the warrants as well as the risk-free interest rate and expected volatility of the Company's common stock. The uncertainty of the fair value measurement due to the use of unobservable inputs and interrelationships between these unobservable inputs could result in higher or lower fair value measurement. The Company has determined that the warrant liabilities' fair values are Level 3 items within the fair value hierarchy. The following table presents the change in the warrant liabilities (in thousands): Balance at December 31, 2020 $ 159 Assumption of Strongbridge private placement warrants 908 Change in fair value of warrants 702 Balance at December 31, 2021 1,769 Change in fair value of warrants and expiration of Strongbridge private placement warrants (1,760) Balance at December 31, 2022 $ 9 There were no transfers between any of the levels of the fair value hierarchy during the years ended December 31, 2022 and 2021. |
Short-term investments
Short-term investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-term investments | Short-term investments The Company classifies investments in debt securities as available-for-sale. The debt securities are reported at fair value with unrealized gains or losses recorded in accumulated other comprehensive income (loss) in the consolidated balance sheets. Refer to "Note 14 - Fair Value Measurements", for information related to the fair value measurements and valuation methods utilized. There were no short-term investments as of December 31, 2022. The following table represents the Company’s available-for-sale investments by major security type as of December 31, 2021 (in thousands): December 31, 2021 Amortized Gross Unrealized Gross Unrealized Losses Total Investments: Commercial paper $ 21,773 $ — $ — $ 21,773 Corporate securities 12,072 2 (7) 12,067 Foreign government securities 1,324 — (2) 1,322 Total available-for-sale investments $ 35,169 $ 2 $ (9) $ 35,162 The Company reviews available-for-sale investments for other-than-temporary impairment loss periodically. The Company considers factors such as the duration, severity of and reason for the decline in value, the potential recovery period and the Company's intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the years ended December 31, 2022 and 2021, the Company did not recognize any other-than-temporary impairment losses. All marketable securities with unrealized losses have been in a loss position for less than twelve months. |
Net loss per common share
Net loss per common share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net loss per common share | Net loss per common share Basic and diluted net loss per common share are determined by dividing net loss applicable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the shares issuable upon conversion, exercise or vesting of Convertible Notes, warrants, stock option awards and RSUs have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares outstanding used to calculate both basic and diluted net loss per common share are the same. The following potentially dilutive securities were excluded from the computation of diluted weighted average common shares outstanding due to their anti-dilutive effect: As of December 31, 2022 2021 Shares to be issued upon conversion of Convertible Notes 15,416,667 15,416,667 Vested and unvested stock options 9,700,161 11,362,336 Restricted stock units 5,255,560 2,005,041 Warrants 8,362,270 6,373,452 Total anti-dilutive securities excluded from EPS computation 2 38,734,658 35,157,496 2 Total anti-dilutive securities exclude CVRs which are settleable in cash, additional Xeris Biopharma shares, or a combination, at the election of the Company. |
Other Employee Benefit Plans
Other Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Compensation and Employee Benefit Plans | Other employee benefit plans Defined Contribution Plan The Company sponsors an employee retirement plan qualifying under Section 401(k) of the Internal Revenue Code for all eligible employees in the United States. Employees become eligible to contribute to the plan upon meeting certain age requirements and 30 days of service. Commencing in 2019, the Company began discretionary matching employee contributions up to certain limits. For the years ended December 31, 2022 and 2021, the Company made $1.7 million and $0.7 million of matching contributions to the plan, respectively. Deferred Compensation Plan |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income taxes A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate of 21% to the Company’s effective income tax rate is as follows (in thousands): Years Ended December 31, 2022 2021 Federal tax benefit at statutory rate $ (20,178) $ (25,772) State tax benefit, net of federal benefit (4,325) (4,422) Research and development and orphan drug credits (320) (350) Uncertain tax positions 94 (302) Permanent adjustments to expenses 726 1,779 Stock-based compensation 414 901 Return to provision adjustment (1,103) (2,450) Statutory tax rate differential 1,600 663 Changes in valuation allowance 21,162 29,642 Other 506 311 Total income tax benefit $ (1,424) $ — The benefit for income taxes for 2022 was attributable to the amortization of the deferred tax liability set up with the Acquisition and it represented the foreign deferred income tax benefit. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A valuation allowance is required to be established or maintained when, based on currently available information, it is more likely than not that all or a portion of a deferred tax asset will not be realized. The guidance on accounting for income taxes provides important factors in determining whether a deferred tax asset will be realized, including whether there has been sufficient taxable income in recent years and whether sufficient income can reasonably be expected in future years in order to utilize the deferred tax asset. For the years ended December 31, 2022 and 2021, the Company evaluated the need to maintain a valuation allowance for deferred tax assets based on the assessment of whether it is more likely than not that deferred tax benefits will be realized through the generation of future taxable income. Appropriate consideration is given to all available evidence, both positive and negative, in assessing the need for a valuation allowance. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating losses $ 111,631 $ 100,790 Federal research and orphan drug credits 8,836 7,184 Stock-based compensation 5,714 3,177 Other temporary differences 32,977 27,094 Valuation allowance (159,043) (137,881) Total assets 115 364 Deferred tax liabilities: Fixed and intangible assets (11) (197) Other deferred tax liabilities (3,622) (5,109) Total liabilities (3,633) (5,306) Net deferred tax liabilities $ (3,518) $ (4,942) As of December 31, 2022, the Company had federal net operating loss carryforwards of $501.4 million and various state net operating loss carryforwards of $345.3 million. As of December 31, 2021, the Company had federal net operating loss carryforwards of $475.7 million and various state net operating loss carryforwards of $309.7 million. Net operating loss carryforwards for the United States federal income tax purposes that were generated prior to January 1, 2018 have a twenty-year carryforward life, and the earliest layers will begin to expire in 2025. Under the Tax Cuts and Jobs Act of 2017, federal net operating losses incurred in 2018 and later years may be carried forward indefinitely, but the deductibility of such net operating losses is limited to 80% of the current year’s taxable income. The United States state net operating loss carryforwards will start to expire in 2029 for the earliest net operating loss layers to the extent there is not sufficient state taxable income to utilize those net operating loss carryforwards. At December 31, 2022, the Company had $6.7 million and $3.1 million of federal and state income tax credits, respectively, to reduce future tax liabilities. At December 31, 2021, the Company had $5.4 million and $2.5 million of federal and state income tax credits, respectively, to reduce future tax liabilities. The federal income tax credits consist primarily of orphan drug credits and research and development credits. The United States state income tax credits consist primarily of California and Illinois research and development credits. Both the United States federal orphan drug credits and research and development credits have a twenty-year carryforward life. The United States federal orphan drug credits and research and development credits will both begin to expire in 2025 and the state research and development credits will begin to expire in 2022. A reconciliation of the beginning and ending amounts of valuation allowances for the years ended December 31, 2022 and 2021 is as follows (in thousands): Valuation allowance at December 31, 2020 $ (92,493) Increase for 2021 activity (45,388) Valuation allowance at December 31, 2021 (137,881) Increase for 2022 activity (21,162) Valuation allowance at December 31, 2022 $ (159,043) The Company is required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken, or are expected to be taken, on an income tax return. The changes in the Company's uncertain income tax positions for the years ended December 31, 2022 and 2021, excluding interest and penalties, consisted of the following (in thousands): December 31, 2022 2021 Beginning balance - uncertain tax positions $ 627 $ 929 Increases related to tax positions taken during the current year 92 17 Increases/(decreases) related to tax positions taken during the prior year 3 (319) Ending balance - uncertain tax positions $ 722 $ 627 For the year ended December 31, 2022, the increase in current year uncertain tax positions was attributable primarily to the United States federal orphan drug credits and research and development credits and the decrease related to tax positions taken during the prior year was a result of return to provision adjustments. In the Company’s balance sheet, uncertain tax positions of $0.7 million were offset against deferred tax assets. Tax years prior to 2019 generally are not subject to examination by the Internal Revenue Service or state or local taxing authorities. The Company policy is to include interest and penalties related to uncertain tax penalties, if any, within the provision for taxes in the statements of operations. During the years ended December 31, 2022 and 2021, the Company incurred no interest and penalties related to income taxes. |
Basis of presentation and sum_2
Basis of presentation and summary of significant accounting policies and estimates (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Revenue recognition | Revenue recognition The Company applies the guidance in ASC 606, Revenue Recognition , to all contracts with customers within the scope of the standard. The Company sells product primarily to wholesalers or a specialty pharmacy that subsequently resell to retail pharmacies or patients. The Company enters into arrangements with payors, group purchasing organizations, and healthcare providers that provide for government-mandated or privately-negotiated rebates, chargebacks and discounts related to the Company’s products. The Company currently sells Gvoke, Keveyis and Recorlev in the United States only. Revenue is recognized when the Company's customer (e.g., a wholesaler or specialty pharmacy) obtains control of promised goods or services, which is when the Company's obligations under the terms of the contract with the customer are satisfied, based on the consideration the Company expects to receive in exchange for those goods or services. Revenues are recorded at the net product sales price, which includes estimated allowances for patient copay assistance programs, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns, all of which are recorded at the time of sale to the pharmaceutical wholesaler or other customer. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, adjustments are made to these allowances in the period in which the actual results or updates to estimates become known. Patient Copay Assistance Program The Company offers savings programs to commercially insured patients under which the cost of a prescription to a patient is discounted. The Company reimburses pharmacies for this discount through a third-party vendor. The Company records an accrual to reduce gross sales for the estimated copay on units sold to wholesalers and other customers. The estimate is based on estimated percentages of products that will be prescribed to qualified patients, expected patient utilization of the discount program, average assistance paid based on reporting from the third-party vendor as well as industry data and estimated levels of inventory in the distribution channel. Accrued copay fees are recorded as a reduction of product revenue and included in accrued trade discounts and rebates on the consolidated balance sheets. Commercial Rebates The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, to provide rebates with respect to utilization of the products and contracted formulary status. The Company accrues estimated rebates based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and records the rebate as a reduction of product revenue. Accrued commercial rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Government Rebates The Company participates in certain federal and state government rebate programs such as the Medicaid Drug Rebate Program, TRICARE Retail Refunds Program, and Medicare Part D Program. The Company accrues estimated rebates and discounts based on actual average rebate amounts and estimated percent of product that will be prescribed to qualified patients and records the rebates as a reduction of product revenue. Accrued government rebates are included in accrued trade discounts and rebates on the consolidated balance sheets. Chargebacks The Company arranges with certain commercial and government entities allowing them to buy products directly from wholesalers at specific prices. These entities purchase products through wholesalers at the discounted price and the wholesalers charge the difference between their list price and the discounted price back to the Company. The Company accrues estimated chargebacks based on estimated percentages of products sold to these entities, contract prices, and estimated levels of inventory in the distribution channel and records the chargebacks as a reduction of product revenue. Accrued chargebacks are recorded as an allowance against trade receivables on the consolidated balance sheets. Product Returns For some products, the Company's customers generally have the right to return product during the period beginning six months prior to the product expiration date and up to one year after the product expiration date. The Company does not have extensive history of product returns and uses various factors to estimate the provision for returns, including the launch date of products, third-party industry data for comparable products in the market and estimated channel inventory data. In a reporting period, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. While the Company believes that the returns reserve is sufficient to avoid a significant reversal of revenue in future periods, if it were to increase or decrease the rate by 1%, it would have a $1.1 million impact on revenue in the year ended December 31, 2022. The Company records estimated product returns in accrued returns reserve on the consolidated balance sheets and as a reduction of product revenue. Prompt Payment Discounts As an incentive for prompt payment, the Company offers a discount to most customers. The Company expects that all eligible customers will comply with the contractual terms to earn the discount, and, therefore, the Company accrues the discount on all eligible sales. The Company records the discount as an allowance against trade accounts receivable on the consolidated balance sheets and as a reduction of product revenue. Service Fees The Company records service fees paid to the wholesaler and specialty pharmacy customers for distribution and inventory management services as a reduction to product revenue. The Company accrues estimated service fees based on contractually determined amounts. Accrued service fees are included in accrued trade discounts and rebates on the consolidated balance sheets. |
New accounting pronouncements | New accounting pronouncements Adopted accounting standards In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) . This standard addresses issuers' accounting for certain modifications or exchanges of freestanding equity-classified written call options. This standard is effective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this standard in first quarter 2022 and it did not have a material impact on the financial statements. In October 2020, the FASB issued ASU 2020-10, Codification Improvements, to make incremental improvements to GAAP and address stakeholder suggestions, including, among other things, clarifying that the requirement to provide comparative information in the financial statements extends to the corresponding disclosures section. This standard will be effective for the Company for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted this standard as of the reporting period beginning January 1, 2022 and it did not have a material impact on the financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard eliminates certain exceptions in the current guidance related to the approach for intra-period tax allocation and the methodology for calculating income taxes in an interim period and amends other aspects of the guidance to help clarify and simplify United States GAAP. This standard is effective for the Company for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted this standard as of the reporting period beginning January 1, 2022 and it did not have a material impact on the financial statements. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to record a right-of-use ("ROU") asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases will be classified as either operating or finance leases under the new guidance. Operating leases will result in straight-line expense in the income statement, similar to current operating leases, and finance leases will result in more expense being recognized in the earlier years of the lease term, similar to current capital leases. This standard is effective for the Company for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. The FASB has extended the effective date of this standard for certain companies. As amended in ASU 2020-05, this standard will be effective for the Company for fiscal years beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The Company adopted the new standard on January 1, 2022, using the modified retrospective approach by recognizing and measuring leases without revising comparative period information or disclosures. The Company elected the transition package of three practical expedients permitted within the standard, which among other things, allows for the carryforward of historical lease classifications. The Company made an accounting policy election to keep leases with terms of twelve months or less off the balance sheet and recognize those lease payments on a straight-line basis over the lease term. The Company recorded a $14.0 million lease liability equal to the present value of lease payments and a $6.3 million operating lease ROU asset, which is the corresponding lease liability adjusted for unamortized lease incentives. The impact of these changes at adoption had no impact on net income or shareholders’ equity. Prior periods were not restated under the new standard. See "Note 18 - Leases" for further details . The impact to the Company’s opening consolidated balance sheets as of January 1, 2022 was as follows (in thousands): As Reported Effect of Adopting Balance at December 31, 2021 ASC 842 January 1, 2022 Assets Right-of-use assets — 6,277 6,277 Other assets 829 (373) 456 Liabilities and stockholders’ equity Other accrued liabilities 49,088 (1,022) 48,066 Current operating lease liabilities — 1,028 1,028 Deferred rent 6,883 (6,883) — Other liabilities 1,676 (204) 1,472 Non-current operating lease liabilities — 12,985 12,985 Pending accounting standards In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This standard eliminates certain accounting models to simplify the accounting for convertible instruments, expands the disclosure requirements related to the terms and features of convertible instruments, and amends the guidance for the derivatives scope exception for contracts settled in an entity’s own equity. This standard enhances the consistency of earnings-per-share ("EPS") calculations by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted EPS calculations and disclosures. This standard is effective for the Company for fiscal years beginning after December 15, 2023. Early adoption is permitted but not earlier than periods beginning after December 15, 2020. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting . This standard provides optional expedients for application of GAAP, if certain criteria are met, to contracts and other transactions that reference London Inter-bank Offered Rate ("LIBOR") or other reference rates that are expected to be discontinued because of reference rate reform. This standard is effective for all entities as of March 12, 2020 through December 31, 2022. On December 21, 2022, the FASB issued ASU 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, which extends the period of time entities can utilize the reference rate reform relief guidance under ASU 2020-04 from December 31, 2022 to December 31, 2024. The Company does not currently expect the adoption of this new standard to have a material impact on the financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This standard requires entities to estimate an expected lifetime credit loss on financial assets ranging from short-term trade accounts receivable to long-term financings and report credit losses using an expected losses model rather than the incurred losses model that was previously used and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if the fair value increases. This standard would have been effective for the Company for fiscal years beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021. The effective date of ASC Topic 326 was then delayed until fiscal years beginning after December 15, 2022 for SEC filers that are eligible to be smaller reporting companies under the SEC’s definition, as well as private companies and not-for-profit entities. The Company is currently evaluating the impact the adoption of this new standard will have on the financial statements. |
Basis of presentation and sum_3
Basis of presentation and summary of significant accounting policies and estimates (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Useful Lives | Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years Property and equipment consisted of the following (in thousands): December 31, 2022 December 31, 2021 Lab equipment $ 3,841 $ 3,739 Furniture and fixtures 1,355 1,355 Computer equipment 474 307 Office equipment 8 28 Software 307 307 Leasehold improvements 5,065 5,026 Total property and equipment 11,050 10,762 Less: accumulated depreciation and amortization (5,534) (4,135) Property and equipment, net $ 5,516 $ 6,627 |
Summary of ASU 2016-12 Adoption Impact | The impact to the Company’s opening consolidated balance sheets as of January 1, 2022 was as follows (in thousands): As Reported Effect of Adopting Balance at December 31, 2021 ASC 842 January 1, 2022 Assets Right-of-use assets — 6,277 6,277 Other assets 829 (373) 456 Liabilities and stockholders’ equity Other accrued liabilities 49,088 (1,022) 48,066 Current operating lease liabilities — 1,028 1,028 Deferred rent 6,883 (6,883) — Other liabilities 1,676 (204) 1,472 Non-current operating lease liabilities — 12,985 12,985 |
Disaggregated revenue (Tables)
Disaggregated revenue (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | The disaggregated revenue by primary products is as follows: Years Ended December 31, 2022 2021 Product revenue (in thousands): Gvoke $ 52,527 $ 38,917 Keveyis 49,307 10,363 Recorlev 7,429 — Product revenue, net 109,263 49,280 Royalty, contract and other revenue 985 310 Total revenue $ 110,248 $ 49,590 |
Business combination (Tables)
Business combination (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of Business Acquisitions, by Acquisition | The acquisition-date fair value of the consideration transferred totaled $169.1 million, which consisted of the following: Fair value of consideration transferred (in thousands, except share number) Xeris Biopharma Holdings, Inc. common shares (58,082,606 shares) $ 137,655 Unexercised Strongbridge options assumed by Xeris Pharma and converted into options to purchase Company Shares 6,404 Strongbridge warrants 2,467 Contingent consideration (Contingent value rights) 22,531 Total consideration $ 169,057 The table below presents the estimated fair value that was allocated to Strongbridge’s assets and liabilities based upon fair values as determined by the Company (in thousands): Fair Value Cash and cash equivalents $ 38,469 Trade accounts receivable 4,344 Inventory 1,862 Prepaid expenses and other current assets 4,683 Property and equipment 161 IPR&D 121,000 Other intangible asset 11,000 Other assets 860 Total identifiable assets acquired 182,379 Accounts payable (279) Other accrued liabilities (13,703) Accrued trade discounts and rebates (4,844) Supply agreement liability (12,000) Deferred tax liabilities (4,942) Other liabilities (413) Total liabilities assumed (36,181) Net identifiable assets acquired 146,198 Goodwill 22,859 Net assets acquired $ 169,057 |
Business Acquisition, Pro Forma Information | The following table presents the pro forma operating results as if Strongbridge had been included in the Company's consolidated statements of operations and comprehensive loss as of January 1, 2020 (unaudited, in thousands): Years Ended December 31, 2022 2021 Revenue $ 110,248 $ 79,509 Net loss $ (94,660) $ (160,342) |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory [Line Items] | |
Schedule of Inventory | The components of inventories consisted of the following (in thousands): December 31, 2022 December 31, 2021 Raw materials $ 7,410 $ 5,181 Work in process 11,367 7,442 Finished goods 5,958 5,495 Inventory $ 24,735 $ 18,118 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property and equipment are carried at cost less accumulated depreciation. Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the respective assets: Lab equipment 5 years Computer equipment 3 years Leasehold improvements Lesser of useful life or lease term Software 3-5 years Furniture and fixtures 5 years Office equipment 5 years Property and equipment consisted of the following (in thousands): December 31, 2022 December 31, 2021 Lab equipment $ 3,841 $ 3,739 Furniture and fixtures 1,355 1,355 Computer equipment 474 307 Office equipment 8 28 Software 307 307 Leasehold improvements 5,065 5,026 Total property and equipment 11,050 10,762 Less: accumulated depreciation and amortization (5,534) (4,135) Property and equipment, net $ 5,516 $ 6,627 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | Identified intangible assets consisted of the following (in thousands): Life (Years) December 31, 2022 December 31, 2021 Gross assets Accumulated amortization Net Gross assets Accumulated amortization Net Definite-lived intangible asset - Keveyis 5 $ 11,000 $ (2,750) $ 8,250 $ 11,000 $ (550) $ 10,450 Definite-lived intangible asset - Recorlev 14 121,000 (8,643) 112,357 121,000 — 121,000 Total intangible assets $ 132,000 $ (11,393) $ 120,607 $ 132,000 $ (550) $ 131,450 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | As of December 31, 2022, expected amortization expense for intangible assets subject to amortization for the next five years is as follows (in thousands): 2023 $ 10,843 2024 10,843 2025 10,843 2026 10,293 2027 8,643 Thereafter 69,142 Total $ 120,607 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses [Abstract] | |
Other Accrued Liabilities | Other accrued liabilities consisted of the following (in thousands): December 31, 2022 December 31, 2021 Accrued employee costs $ 13,400 $ 19,638 Supply agreement - current portion 6,720 6,009 Accrued supply chain costs 562 595 Accrued marketing costs 2,593 3,237 Accrued research and development costs 1,411 1,998 Accrued restructuring charges 2,799 6,715 Accrued interest expense 4,656 1,413 Accrued Strongbridge transaction costs — 1,839 Accrued other costs 4,645 7,644 Other accrued liabilities $ 36,786 $ 49,088 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The components of debt are as follows (in thousands): December 31, 2022 December 31, 2021 Convertible Notes $ 47,175 $ 47,175 Loan facility 144,487 43,500 Less: unamortized debt issuance costs (4,587) (2,608) Long-term debt, net of unamortized debt issuance costs $ 187,075 $ 88,067 |
Schedule of Maturities of Long-term Debt | The following table sets forth the Company’s future minimum principal payments on the Convertible Note and the loan facility (in thousands): 2023 $ — 2024 — 2025 47,175 2026 — 2027 150,000 $ 197,175 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | As of December 31, 2022, the following warrants were outstanding: Warrants classified as liabilities: Outstanding Warrants Exercise Price per Warrant Expiration Date 2018 Term A Warrants 53,720 $11.169 February 2025 2018 Term B Warrants 40,292 $11.169 September 2025 94,012 Warrants classified as equities: Warrants in connection with CRG loan agreement 309,122 $9.410 July 2024 Warrants in connection with CRG loan amendment in January 2018 978,628 $12.760 January 2025 Warrants in connection with Avenue Capital loan agreement 209,633 $2.390 May 2025 Warrants in connection with Avenue Capital loan agreement 209,633 $2.390 December 2025 Warrants in connection with Horizon and Oxford loan agreement 125,999 $3.130 December 2026 Warrants in connection with Armistice securities purchase agreement 5,119,454 $3.223 February 2027 Warrants in connection with Hayfin loan agreement 1,315,789 $2.280 March 2029 8,268,258 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases (Topic 840) | Under the previous lease accounting prior to the adoption of ASC 842, future minimum annual rental commitments for operating leases as of December 31, 2021 were as follows (in thousands): 2022 $ 1,813 2023 2,031 2024 1,981 2025 1,931 2026 1,982 Thereafter 11,741 Total minimum lease payments $ 21,479 |
Restructuring costs (Tables)
Restructuring costs (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table summarizes the initial restructuring reserve in connection with the Strongbridge acquisition and the payments made during the years ended December 31, 2022 and 2021 (in thousands): Restructuring Costs Restructuring costs $ 9,657 Payments (2,944) Balance accrued at December 31, 2021 $ 6,713 Restructuring costs $ 1,488 Payments (5,402) Balance accrued at December 31, 2022 $ 2,799 |
Stock Compensation Plan (Tables
Stock Compensation Plan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The fair value of stock options granted was estimated with the following weighted average assumptions: Years Ended December 31, 2022 2021 Expected term (years) 5.5 6.0 Risk-free interest rate 3.01% 1.15% Expected volatility 80.18% 76.34% Expected dividends — — |
Share-based Compensation, Activity | Stock option activity under the 2011 Plan, 2018 Plan, Inducement Plan and Assumed Plans for the year ended December 31, 2022 was as follows: Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Outstanding - December 31, 2021 11,362,336 $ 5.86 5.62 Granted 175,000 2.10 Exercised (11,228) 0.69 Forfeited (87,680) 5.25 Expired (1,738,267) 8.31 Outstanding - December 31, 2022 9,700,161 $ 5.37 4.76 Exercisable - December 31, 2022 9,032,882 $ 5.44 4.51 Vested and expected to vest at December 31, 2022 9,700,161 $ 5.37 4.76 |
Share-based Payment Arrangement, Expensed and Capitalized, Amount | The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, RSUs and the ESPP (in thousands): Years Ended December 31, 2022 2021 Cost of goods sold $ — $ 106 Research and development 1,593 1,696 Selling, general and administrative 10,567 9,579 Total stock-based compensation expense $ 12,160 $ 11,381 |
Schedule of Nonvested Restricted Stock Units Activity | A summary of outstanding RSU awards and the activity for the year ended December 31, 2022 was as follows: Number of Units Weighted Average Grant Date Fair Value Unvested balance - December 31, 2021 2,005,041 $ 5.15 Granted 4,477,850 2.71 Vested (708,970) 5.46 Forfeited (518,361) 2.90 Unvested balance - December 31, 2022 5,255,560 $ 3.25 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Lease Cost | Supplemental cash flow information related to the Company’s operating and finance leases was as follows (in thousands): Year Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $2,159 Right of use assets obtained in exchange for new lease obligations: Operating leases — The components of lease expense were as follows (in thousand): Lease cost Year Ended Operating lease expense 1,799 Variable lease cost 1,091 Sublease income (212) Total lease cost 2,678 |
Schedule of Operating Lease Maturities (Topic 842) | As of December 31, 2022, maturities of lease liabilities are summarized as follows (in thousands): 2023 $ 1,586 2024 1,556 2025 1,820 2026 1,869 2027 1,918 Thereafter 10,674 Total lease payments 19,423 Less: Effect of discounting to net present value (8,441) Present value of lease liabilities $ 10,982 Operating lease liabilities, current 1,580 Operating lease liabilities, non-current 9,402 Total operating lease liabilities $ 10,982 |
Schedule of Future Minimum Rental Payments for Operating Leases (Topic 840) | Under the previous lease accounting prior to the adoption of ASC 842, future minimum annual rental commitments for operating leases as of December 31, 2021 were as follows (in thousands): 2022 $ 1,813 2023 2,031 2024 1,981 2025 1,931 2026 1,982 Thereafter 11,741 Total minimum lease payments $ 21,479 |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The following tables present the Company’s fair value hierarchy for those assets and liabilities measured at fair value as of December 31, 2022 and December 31, 2021 (in thousands): Total as of December 31, 2022 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 121,966 $ 121,966 $ — $ — Liabilities Contingent value rights $ 25,688 $ — $ — $ 25,688 Warrant liabilities $ 9 $ — $ — $ 9 Total as of December 31, 2021 Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash and money market funds $ 67,271 $ 67,271 $ — $ — Investments: Corporate securities 12,067 — 12,067 — Commercial paper 21,773 — 21,773 — Foreign government 1,322 — 1,322 — Total investments $ 35,162 $ — $ 35,162 $ — Liabilities Contingent value rights $ 22,531 $ — $ — $ 22,531 Warrant liabilities $ 1,769 $ — $ — $ 1,769 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table presents the change in the CVR liabilities (in thousands): Balance at the Acquisition $ 22,531 Change in fair value of CVRs — Balance at December 31, 2021 22,531 Change in fair value of CVRs 3,157 Balance at December 31, 2022 $ 25,688 Balance at December 31, 2020 $ 159 Assumption of Strongbridge private placement warrants 908 Change in fair value of warrants 702 Balance at December 31, 2021 1,769 Change in fair value of warrants and expiration of Strongbridge private placement warrants (1,760) Balance at December 31, 2022 $ 9 |
Short-term investments (Tables)
Short-term investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Debt Securities, Available-for-sale | The following table represents the Company’s available-for-sale investments by major security type as of December 31, 2021 (in thousands): December 31, 2021 Amortized Gross Unrealized Gross Unrealized Losses Total Investments: Commercial paper $ 21,773 $ — $ — $ 21,773 Corporate securities 12,072 2 (7) 12,067 Foreign government securities 1,324 — (2) 1,322 Total available-for-sale investments $ 35,169 $ 2 $ (9) $ 35,162 |
Net loss per common share (Tabl
Net loss per common share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities were excluded from the computation of diluted weighted average common shares outstanding due to their anti-dilutive effect: As of December 31, 2022 2021 Shares to be issued upon conversion of Convertible Notes 15,416,667 15,416,667 Vested and unvested stock options 9,700,161 11,362,336 Restricted stock units 5,255,560 2,005,041 Warrants 8,362,270 6,373,452 Total anti-dilutive securities excluded from EPS computation 2 38,734,658 35,157,496 2 Total anti-dilutive securities exclude CVRs which are settleable in cash, additional Xeris Biopharma shares, or a combination, at the election of the Company. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount | The following table summarizes the reporting of total stock-based compensation expense resulting from stock options, RSUs and the ESPP (in thousands): Years Ended December 31, 2022 2021 Cost of goods sold $ — $ 106 Research and development 1,593 1,696 Selling, general and administrative 10,567 9,579 Total stock-based compensation expense $ 12,160 $ 11,381 |
Summary of Valuation Allowance [Table Text Block] | A reconciliation of the beginning and ending amounts of valuation allowances for the years ended December 31, 2022 and 2021 is as follows (in thousands): Valuation allowance at December 31, 2020 $ (92,493) Increase for 2021 activity (45,388) Valuation allowance at December 31, 2021 (137,881) Increase for 2022 activity (21,162) Valuation allowance at December 31, 2022 $ (159,043) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate of 21% to the Company’s effective income tax rate is as follows (in thousands): Years Ended December 31, 2022 2021 Federal tax benefit at statutory rate $ (20,178) $ (25,772) State tax benefit, net of federal benefit (4,325) (4,422) Research and development and orphan drug credits (320) (350) Uncertain tax positions 94 (302) Permanent adjustments to expenses 726 1,779 Stock-based compensation 414 901 Return to provision adjustment (1,103) (2,450) Statutory tax rate differential 1,600 663 Changes in valuation allowance 21,162 29,642 Other 506 311 Total income tax benefit $ (1,424) $ — |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating losses $ 111,631 $ 100,790 Federal research and orphan drug credits 8,836 7,184 Stock-based compensation 5,714 3,177 Other temporary differences 32,977 27,094 Valuation allowance (159,043) (137,881) Total assets 115 364 Deferred tax liabilities: Fixed and intangible assets (11) (197) Other deferred tax liabilities (3,622) (5,109) Total liabilities (3,633) (5,306) Net deferred tax liabilities $ (3,518) $ (4,942) |
Summary of Positions for which Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Table Text Block] | The Company is required to recognize the financial statement effects of a tax position when it is more likely than not, based on the technical merits, that the position will be sustained upon examination. The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken, or are expected to be taken, on an income tax return. The changes in the Company's uncertain income tax positions for the years ended December 31, 2022 and 2021, excluding interest and penalties, consisted of the following (in thousands): December 31, 2022 2021 Beginning balance - uncertain tax positions $ 627 $ 929 Increases related to tax positions taken during the current year 92 17 Increases/(decreases) related to tax positions taken during the prior year 3 (319) Ending balance - uncertain tax positions $ 722 $ 627 |
Organization and Nature of th_2
Organization and Nature of the Business Narrative (Details) $ / shares in Units, $ in Thousands | Dec. 31, 2022 USD ($) commerciallyAvailableProduct $ / shares | Dec. 31, 2021 USD ($) $ / shares | Oct. 06, 2021 $ / shares |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number Of Commercially Available Products | commerciallyAvailableProduct | 3 | ||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Accumulated deficit | $ | $ 554,770 | $ 460,110 |
Basis of presentation and sum_4
Basis of presentation and summary of significant accounting policies and estimates - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2022 | |
Concentration Risk [Line Items] | |||
Revenue product return description | For some products, the Company's customers generally have the right to return product during the period beginning six months prior to the product expiration date and up to one year after the product expiration date. The Company does not have extensive history of product returns and uses various factors to estimate the provision for returns, including the launch date of products, third-party industry data for comparable products in the market and estimated channel inventory data. In a reporting period, the Company may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels, inventory dating, prescription data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. | ||
Revenue performance obligation, product return, rate increase (decrease) scenario, percent | 1% | ||
Revenue performance obligation, product return, impact on revenue of 1% increase (decrease) | $ 1,100 | ||
Present value of lease liabilities | 10,982 | ||
Right-of-use assets | $ 3,992 | $ 0 | |
Accounting Standards Update 2016-02 | |||
Concentration Risk [Line Items] | |||
Present value of lease liabilities | $ 14,000 | ||
Right-of-use assets | $ 6,300 | ||
Revenue Benchmark | Customer Concentration Risk | Four Customers | Product revenue, net | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 96% | 95% | |
Accounts Receivable | Customer Concentration Risk | Four Customers | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 99% | 99% |
Basis of presentation and sum_5
Basis of presentation and summary of significant accounting policies and estimates - Schedule of Property and Equipment Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Lab equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 5 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 3 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 5 years |
Office equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 5 years |
Software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 3 years |
Software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 5 years |
Basis of presentation and sum_6
Basis of presentation and summary of significant accounting policies and estimates - Summary of ASU 2016-02 Adoption Impact (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right-of-use assets | $ 3,992 | $ 0 | |
Other assets | 4,730 | 829 | |
Other accrued liabilities | 36,786 | 49,088 | |
Current operating lease liabilities | 1,580 | 0 | |
Deferred rent | 0 | 6,883 | |
Other liabilities | 31 | 1,676 | |
Non-current operating lease liabilities | $ 9,402 | $ 0 | |
Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right-of-use assets | $ 6,300 | ||
Cumulative Effect, Period of Adoption, Adjustment | Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right-of-use assets | 6,277 | ||
Other assets | (373) | ||
Other accrued liabilities | (1,022) | ||
Current operating lease liabilities | 1,028 | ||
Deferred rent | (6,883) | ||
Other liabilities | (204) | ||
Non-current operating lease liabilities | 12,985 | ||
Cumulative Effect, Period of Adoption, Adjusted Balance | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right-of-use assets | 6,277 | ||
Other assets | 456 | ||
Other accrued liabilities | 48,066 | ||
Current operating lease liabilities | 1,028 | ||
Deferred rent | 0 | ||
Other liabilities | 1,472 | ||
Non-current operating lease liabilities | $ 12,985 |
Revenue from Contract with Cust
Revenue from Contract with Customer (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Net sales | $ 110,248 | $ 49,590 |
Product revenue, net | ||
Disaggregation of Revenue [Line Items] | ||
Net sales | 109,263 | 49,280 |
Gvoke | ||
Disaggregation of Revenue [Line Items] | ||
Net sales | 52,527 | 38,917 |
Keveyis | ||
Disaggregation of Revenue [Line Items] | ||
Net sales | 49,307 | 10,363 |
Recorlev | ||
Disaggregation of Revenue [Line Items] | ||
Net sales | 7,429 | 0 |
Royalty, contract and other revenue | ||
Disaggregation of Revenue [Line Items] | ||
Net sales | $ 985 | $ 310 |
Business combination (Details)
Business combination (Details) $ / shares in Units, contingentValueRight in Millions | 12 Months Ended | ||||
Oct. 05, 2021 USD ($) conversionRate contingentValueRight $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) $ / shares | Oct. 06, 2021 $ / shares | |
Business Acquisition [Line Items] | |||||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Goodwill | $ 22,859,000 | $ 22,859,000 | |||
Depreciation Depletion and Amortization, not including asset impairments | 1,400,000 | 1,300,000 | |||
Warrants | |||||
Business Acquisition [Line Items] | |||||
Class Of Warrant Or Right, Multiplier Period | 20 days | ||||
Strongbridge | |||||
Business Acquisition [Line Items] | |||||
Business Combination, Shares Conversion Rate | conversionRate | 0.7840 | ||||
Contingent Value Right Maximum Value Per Right | $ / shares | $ 1 | ||||
Business Combination, Contingent Consideration, Payable Per Contingent Value Right | $ 1 | ||||
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares | shares | 58,082,606 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Cash and Equivalents | $ 38,469,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Assets, Receivables | 4,344,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Inventory | 1,862,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Assets, Prepaid Expense and Other Assets | 4,683,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Property, Plant, and Equipment | 161,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Indefinite-Lived Intangible Assets | 121,000,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Finite-Lived Intangibles | 11,000,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Other Noncurrent Assets | 860,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets | 182,379,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Accounts Payable | (279,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Accrued Liabilities, Other | (13,703,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Accrued Trade Discounts And Rebates | (4,844,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Supply Agreement | (12,000,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Deferred Tax Liabilities | (4,942,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Noncurrent Liabilities, Other | (413,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Liabilities | (36,181,000) | ||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Net | 146,198,000 | ||||
Goodwill | 22,859,000 | ||||
Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net | 169,057,000 | ||||
Business Combination, Consideration Transferred | 169,057,000 | ||||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 137,655,000 | ||||
Business Combination, Consideration Transferred, Value Of Options Assumed | 6,404,000 | ||||
Business Combination, Consideration Transferred, Value Of Warrants Assumed | 2,467,000 | ||||
Business Combination, Consideration Transferred, Other | $ 22,531,000 | ||||
Business Combination, Contingent Consideration, Number Of Additional Contingent Value Rights To Be Issued | contingentValueRight | 10.5 | ||||
Business Combination, Contingent Consideration, Number Of Contingent Value Rights | contingentValueRight | 74.1 | ||||
Business Acquisition, Pro Forma Revenue | 110,248,000 | 79,509,000 | |||
Business Acquisition, Pro Forma Net Income (Loss) | (94,660,000) | $ (160,342,000) | |||
Expected volatility | 89.63% | ||||
Goodwill, Purchase Accounting Adjustments | $ 0 | ||||
Strongbridge | Commercial Product Kaveyis | |||||
Business Acquisition [Line Items] | |||||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 5 years | ||||
Strongbridge | Xeris | |||||
Business Acquisition [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Weighted Average Volatility Rate Per Entity | 60% | ||||
Strongbridge | Stonebridge | |||||
Business Acquisition [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Weighted Average Volatility Rate Per Entity | 40% | ||||
Strongbridge | Achievement In Net Sales Of Keveyis In 2023 | |||||
Business Acquisition [Line Items] | |||||
Business Combination, Contingent Consideration, Payable Per Contingent Value Right | $ 0.25 | ||||
Business Combination, Contingent Consideration, Net Sales Threshold | 40,000,000 | ||||
Strongbridge | Achievement In Net Sales Of Recorlev In 2023 | |||||
Business Acquisition [Line Items] | |||||
Business Combination, Contingent Consideration, Payable Per Contingent Value Right | 0.25 | ||||
Business Combination, Contingent Consideration, Net Sales Threshold | 40,000,000 | ||||
Strongbridge | Achievement In Net Sales Of Recorlev In 2024 | |||||
Business Acquisition [Line Items] | |||||
Business Combination, Contingent Consideration, Payable Per Contingent Value Right | 0.50 | ||||
Business Combination, Contingent Consideration, Net Sales Threshold | $ 80,000,000 | ||||
Strongbridge | Selling, General and Administrative Expenses [Member] | |||||
Business Acquisition [Line Items] | |||||
Business Combination, Transaction Costs | $ 8,600,000 | ||||
Strongbridge | Warrants | |||||
Business Acquisition [Line Items] | |||||
Class Of Warrant Or Right, Multiplier Period | 20 days | ||||
Exercise Price Per Warrant | $ / shares | $ 2.50 | ||||
Class Of Warrant Or Right, Threshold Trading Days | 3 days | ||||
Strongbridge | Warrants | Measurement Input, Price Volatility | |||||
Business Acquisition [Line Items] | |||||
Warrants and Rights Outstanding, Measurement Input | 0.50 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Inventory Valuation Reserves | $ 1,300 | $ 1,000 |
Inventory Components of Invento
Inventory Components of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Raw materials | $ 7,410 | $ 5,181 |
Work in process | 11,367 | 7,442 |
Finished goods | 5,958 | 5,495 |
Inventory | $ 24,735 | $ 18,118 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 11,050 | $ 10,762 |
Less: accumulated depreciation and amortization | (5,534) | (4,135) |
Property and equipment, net | 5,516 | 6,627 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,841 | 3,739 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,355 | 1,355 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 474 | 307 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 8 | 28 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 307 | 307 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,065 | $ 5,026 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation Depletion and Amortization, not including asset impairments | $ 1,400 | $ 1,300 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross assets | $ 132,000 | $ 132,000 |
Accumulated amortization | (11,393) | (550) |
Net | $ 120,607 | 131,450 |
Developed Technology Rights - Keveyis | ||
Finite-Lived Intangible Assets [Line Items] | ||
Life (Years) | 5 years | |
Gross assets | $ 11,000 | 11,000 |
Accumulated amortization | (2,750) | (550) |
Net | $ 8,250 | 10,450 |
Developed Technology Rights - Recorlev | ||
Finite-Lived Intangible Assets [Line Items] | ||
Life (Years) | 14 years | |
Gross assets | $ 121,000 | 121,000 |
Accumulated amortization | (8,643) | 0 |
Net | $ 112,357 | $ 121,000 |
Intangible Assets - Expected Am
Intangible Assets - Expected Amortization (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2023 | $ 10,843 | |
2024 | 10,843 | |
2025 | 10,843 | |
2026 | 10,293 | |
2027 | 8,643 | |
Thereafter | 69,142 | |
Net | $ 120,607 | $ 131,450 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses [Abstract] | ||
Accrued employee costs | $ 13,400 | $ 19,638 |
Supply agreement - current portion | 6,720 | 6,009 |
Accrued supply chain costs | 562 | 595 |
Accrued marketing and selling costs | 2,593 | 3,237 |
Accrued research and development costs | 1,411 | 1,998 |
Accrued restructuring charges | 2,799 | 6,715 |
Accrued interest expense | 4,656 | 1,413 |
Accrued Strongbridge transaction costs | 0 | 1,839 |
Accrued other costs | 4,645 | 7,644 |
Other accrued liabilities | $ 36,786 | $ 49,088 |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Dec. 28, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) shares | Dec. 31, 2020 USD ($) shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) | Jul. 07, 2020 USD ($) | Sep. 30, 2019 USD ($) tranche | |
Debt Instrument [Line Items] | ||||||||
Convertible notes purchased, due to exercise of underwriter option | $ 11,300,000 | |||||||
Principal amount of convertible notes converted | $ 8,400,000 | |||||||
Issuance of common stock upon conversion of convertible notes, shares | shares | 2,736,591 | |||||||
Principal amount of convertible notes converted privately | $ 30,700,000 | |||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities privately exchanged | shares | 10,435,200 | |||||||
Loss on the convertible note exchange transactions | $ 2,600,000 | |||||||
Proceeds from issuance of debt | $ 146,214,000 | $ 0 | ||||||
Payments of debt issuance costs | $ 4,876,000 | 0 | ||||||
Outstanding warrants | shares | 94,012 | |||||||
Interest expense | $ (15,325,000) | (7,180,000) | ||||||
Amortization of debt issuance costs | 1,559,000 | 961,000 | ||||||
Loss on extinguishment of debt | $ 1,223,000 | 0 | ||||||
Warrants In Connection With Hayfin Loan Agreement Due March 2029 | ||||||||
Debt Instrument [Line Items] | ||||||||
Outstanding warrants | shares | 1,315,789 | |||||||
Exercise Price Per Warrant | $ / shares | $ 2.28 | |||||||
Convertible Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Face Amount | $ 144,487,000 | 43,500,000 | $ 86,300,000 | |||||
Cash interest per annum on convertible notes | 5% | 5% | ||||||
Debt Issuance Costs, Gross | $ 5,100,000 | |||||||
Initial conversion rate for Convertible Notes | shares | 326.7974 | 326.7974 | ||||||
Per principal amount of Convertible Notes | $ 1,000 | $ 1,000 | ||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 3.06 | |||||||
Maximum conversion rate of Convertible Notes | shares | 367.6470 | |||||||
Term A Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Face Amount | $ 60,000,000 | |||||||
Repayments of Notes Payable | 20,000,000 | |||||||
PPP Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayments of Notes Payable | $ 4,200,000 | |||||||
Amended Loan and Security Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 85,000,000 | |||||||
Debt Instrument, Number Of Tranches | tranche | 3 | |||||||
Secured Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Face Amount | $ 100,000,000 | |||||||
Delayed Draw Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Face Amount | 50,000,000 | |||||||
Proceeds from issuance of debt | $ 50,000,000 | |||||||
Hayfin Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Face Amount | 43,500,000 | |||||||
Debt Instrument, Payment Of Fees | $ 2,100,000 | |||||||
Debt Instrument, Interest Rate During Period | 9% | |||||||
Debt Instrument, Interest Rate, Replacement Rate | 8% | |||||||
Debt Instrument, Replacement Rate | 1% | |||||||
Debt Instrument, Basis Spread on Variable Rate | 0.26161% | |||||||
Payments of debt issuance costs | $ 3,600,000 | |||||||
Debt Instrument, Interest Rate, Effective Percentage | 11.80% | |||||||
Debt Instrument, Covenant, Maximum Cash On Hand | $ 15,000,000 | |||||||
Debt Instrument, Covenant, Prepayment Fee One, Percentage | 5% | |||||||
Debt Instrument, Covenant, Prepayment Fee Two, Percentage | 3% | |||||||
Debt Instrument, Covenant, Prepayment Fee Three, Percentage | 0% | |||||||
Hayfin Loan | Prime Rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt Instrument, Basis Spread on Variable Rate | 2% | |||||||
Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Amortization of debt issuance costs | $ 1,600,000 | $ 1,000,000 |
Long-Term Debt - Components of
Long-Term Debt - Components of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 07, 2020 |
Debt Instrument [Line Items] | |||
Unamortized Debt Issuance Expense | $ (4,587) | $ (2,608) | |
Long-term debt, net of unamortized debt issuance costs | 187,075 | 88,067 | |
Senior Loans | |||
Debt Instrument [Line Items] | |||
Debt Instrument, Face Amount | 47,175 | 47,175 | |
Convertible Notes | |||
Debt Instrument [Line Items] | |||
Debt Instrument, Face Amount | $ 144,487 | $ 43,500 | $ 86,300 |
Long-Term Debt - Future Princip
Long-Term Debt - Future Principal Payments (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 0 |
2024 | 0 |
2025 | 47,175 |
2026 | 0 |
2027 | 150,000 |
Long-term debt total | $ 197,175 |
Stockholders' equity (Details)
Stockholders' equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||||
Jan. 03, 2022 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 06, 2021 | Mar. 17, 2021 | |
Class of Stock [Line Items] | ||||||
Total common stock and preferred stock authorized shares | 375,000,000 | |||||
Common stock shares authorized (in shares) | 350,000,000 | 350,000,000 | ||||
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Preferred stock shares authorized (in shares) | 25,000,000 | 25,000,000 | 6,553,398 | |||
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Shares issued (in usd per share) | $ 4.12 | |||||
Net proceeds from issuance of public offering | $ 26.9 | |||||
Warrants In Connection With Armistice Securities Purchase Agreement | ||||||
Class of Stock [Line Items] | ||||||
Warrants term | 5 years | |||||
Private Placement | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from sale of stock | $ 30 | |||||
Private Placement | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Common stock par value (in dollars per share) | $ 0.0001 | |||||
Stock issued (in shares) | 10,238,908 | |||||
Price per share of stock issued (in dollars per share) | $ 2.93 | |||||
Private Placement | Warrants | ||||||
Class of Stock [Line Items] | ||||||
Stock issued (in shares) | 5,119,454 | |||||
Price per share of stock issued (in dollars per share) | $ 3.223 |
Warrants Narrative (Details)
Warrants Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Warrant or Right [Line Items] | ||
Outstanding warrants | 94,012 | |
Change in fair value of warrants and expiration of Strongbridge private placement warrants | $ (1,760) | $ 702 |
Term A Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Outstanding warrants | 53,720 | |
Exercise Price Per Warrant | $ 11.169 | |
Change in fair value of warrants and expiration of Strongbridge private placement warrants | $ 49 | 39 |
Term B Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Outstanding warrants | 40,292 | |
Exercise Price Per Warrant | $ 11.169 | |
Change in fair value of warrants and expiration of Strongbridge private placement warrants | $ 35 | 27 |
Assumed Strongbridge Private Placement Warrants | ||
Class of Warrant or Right [Line Items] | ||
Change in fair value of warrants and expiration of Strongbridge private placement warrants | $ 1,700 | $ (768) |
Warrants In Connection With Armistice Securities Purchase Agreement | ||
Class of Warrant or Right [Line Items] | ||
Outstanding warrants | 5,119,454 | |
Exercise Price Per Warrant | $ 3.223 | |
Warrants term | 5 years |
Warrants Schedule of Stockholde
Warrants Schedule of Stockholders' Equity Note, Warrants or Rights (Details) | Dec. 31, 2022 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 94,012 |
Term A Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 53,720 |
Exercise Price Per Warrant | $ / shares | $ 11.169 |
Term B Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 40,292 |
Exercise Price Per Warrant | $ / shares | $ 11.169 |
Warrants In Connection With Horizon and Oxford Loan Agreement | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 125,999 |
Exercise Price Per Warrant | $ / shares | $ 3.130 |
Warrants In Connection With CRG Loan Agreement | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 309,122 |
Exercise Price Per Warrant | $ / shares | $ 9.410 |
Warrants In Connection With CRG Loan Amendment Dated January 2028 | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 978,628 |
Exercise Price Per Warrant | $ / shares | $ 12.760 |
Warrants In Connection With Avenue Capital Loan Agreement Due May 2025 | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 209,633 |
Exercise Price Per Warrant | $ / shares | $ 2.390 |
Warrants In Connection With Avenue Capital Loan Agreement Due December 2025 | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 209,633 |
Exercise Price Per Warrant | $ / shares | $ 2.390 |
Warrants In Connection With Armistice Securities Purchase Agreement | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 5,119,454 |
Exercise Price Per Warrant | $ / shares | $ 3.223 |
Warrants In Connection With Hayfin Loan Agreement Due March 2029 | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 1,315,789 |
Exercise Price Per Warrant | $ / shares | $ 2.28 |
Total Warrants Assumed | |
Class of Warrant or Right [Line Items] | |
Outstanding warrants | 8,268,258 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ / shares in Units, contingentValueRight in Millions, $ in Millions | 12 Months Ended | 72 Months Ended | |
Dec. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | Oct. 05, 2021 contingentValueRight $ / shares | |
Letter of Credit | |||
Other Commitments [Line Items] | |||
Line of Credit Facility, Remaining Borrowing Capacity | $ 4.3 | ||
Letter of Credit | Collateral Pledged | |||
Other Commitments [Line Items] | |||
Restricted Cash | 4.3 | ||
Strongbridge | |||
Other Commitments [Line Items] | |||
Contingent Value Right Maximum Value Per Right | $ / shares | $ 1 | ||
Business Combination, Contingent Consideration, Number Of Contingent Value Rights | contingentValueRight | 74.1 | ||
Business Combination, Contingent Consideration, Number Of Additional Contingent Value Rights To Be Issued | contingentValueRight | 10.5 | ||
Purchase Commitment | |||
Other Commitments [Line Items] | |||
Purchase Commitment, Remaining Minimum Amount Committed | $ 8 | ||
Number of years extended beyond termination of orphan exclusivity period | 2 years | ||
Purchase Commitment | Subsequent Event | |||
Other Commitments [Line Items] | |||
Purchase commitment term | 6 years | ||
Purchase Commitment | Forecast | |||
Other Commitments [Line Items] | |||
Long-term Purchase Commitment, Amount | $ 29.1 |
Restructuring costs (Details)
Restructuring costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring Cost and Reserve [Line Items] | ||
Accrued restructuring charges | $ 2,799 | $ 6,715 |
2021 Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring and Related Cost, Expected Cost | 11,100 | |
Employee Severance | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring costs | 1,488 | 9,657 |
Payments | 5,402 | 2,944 |
Accrued restructuring charges | 2,799 | 6,713 |
Employee Severance | 2021 Restructuring Plan | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring and Related Cost, Incurred Cost | $ 1,500 | |
Relocation | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring costs | 300 | |
Accrued restructuring charges | $ 2 |
Stock Compensation Plan Narrati
Stock Compensation Plan Narrative (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 05, 2021 | Mar. 31, 2019 | Jun. 30, 2018 | Dec. 31, 2011 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,822,000 | 4,714,982 | |||||
Least amount of annual increase of shares available for issuance | 386,000 | ||||||
Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 1,700,000 | ||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 4 months 24 days | ||||||
Options | Minimum | Share-based Payment Arrangement, Tranche One | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 2 years | ||||||
Options | Minimum | Share-based Payment Arrangement, Tranche Two | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | ||||||
Options | Minimum | Share-based Payment Arrangement, Tranche Three | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||||||
Exchange Offer | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 7 years | ||||||
Exchange Offer | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||
Stonebridge Rollover Option | Stonebridge | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | $ 4.50 | ||||||
Restricted stock units | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 10,300,000 | ||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 9 months 18 days | ||||||
Restricted stock units | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | ||||||
Restricted stock units | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||||||
2018 Stock Option and Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentage shares available for issuance automatically increase annually | 4% | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 4,994,933 | 2,384,448 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 3,380,363 | ||||||
Employee Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 193,000 | ||||||
Maximum employee payroll deduction percentage | 15% | ||||||
Common stock value, tax limit on employee stock purchase plan | $ 25,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 85% | ||||||
Percentage shares available for issuance automatically increase annually | 1% | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 386,000 | 386,000 | |||||
Issuance of common stock through employee stock purchase plan (in shares) | 671,867 | ||||||
Share price (in usd per share) | $ 1.45 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 191,860 | ||||||
Equity Inducement Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 750,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 305,349 | ||||||
Assumed Plans | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 3,674,889 |
Stock Compensation Plan Share-b
Stock Compensation Plan Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years 6 months | 6 years |
Risk-free interest rate | 3.01% | 1.15% |
Expected volatility | 80.18% | 76.34% |
Expected dividends | 0% | 0% |
Employee Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 months | 6 months |
Risk-free interest rate | 1.18% | 0.08% |
Expected volatility | 79.50% | 77.40% |
Expected dividends | 0% | 0% |
Stock Compensation Plan Employe
Stock Compensation Plan Employee Stock Award Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 9,700,161 | 11,362,336 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 5.37 | $ 5.86 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 4 years 9 months 3 days | 5 years 7 months 13 days |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 175,000 | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2.10 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | (11,228) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 0.69 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Number of Shares | (87,680) | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price | $ 5.25 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | (1,738,267) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price | $ 8.31 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 9,032,882 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 5.44 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 9,700,161 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ 5.37 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 4 years 6 months 3 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 4 years 9 months 3 days | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.43 |
Stock Compensation Plan Stock-B
Stock Compensation Plan Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 12,160 | $ 11,381 |
Research and development expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 1,593 | 1,696 |
Selling, General and Administrative Expenses [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 10,567 | 9,579 |
Cost of Sales | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 0 | $ 106 |
Stock Compensation Plan Restric
Stock Compensation Plan Restricted stock units, activity (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 9,700,161 | 11,362,336 |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 175,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value | $ 3.25 | $ 5.15 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | 2.71 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value | 5.46 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeitures, Weighted Average Grant Date Fair Value | $ 2.90 | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 10.3 | |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 9 months 18 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 5,255,560 | 2,005,041 |
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 4,477,850 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | (708,970) | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period | (518,361) |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 USD ($) | Apr. 01, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 29, 2022 leaseExtension ft² | |
Lessee, Lease, Description [Line Items] | ||||
Present value of lease liabilities | $ 10,982 | |||
Right-of-use assets | $ 0 | $ 3,992 | ||
Remaining lease term, weighted-average | 7 years 7 months 6 days | |||
Lease discount rate, weighted-average | 11.40% | |||
Operating lease rent expense | $ 2,400 | |||
Minimum | ||||
Lessee, Lease, Description [Line Items] | ||||
Renewal term | 1 year | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Renewal term | 5 years | |||
Fulton Ogden Venture, LLC | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease square footage | ft² | 87,032 | |||
Number of options to extend | leaseExtension | 2 | |||
Renewal term | 5 years | |||
Forecast | Fulton Ogden Venture, LLC | ||||
Lessee, Lease, Description [Line Items] | ||||
Present value of lease liabilities | $ 22,800 | |||
Right-of-use assets | $ 23,100 |
Leases - Summary of Lease Cost
Leases - Summary of Lease Cost Information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows for operating leases | $ 2,159 |
Right of use assets obtained in exchange for new lease obligations: | |
Operating leases | 0 |
Lease cost | |
Operating lease expense | 1,799 |
Variable lease cost | 1,091 |
Sublease income | (212) |
Total lease cost | $ 2,678 |
Leases - Schedule of Operating
Leases - Schedule of Operating Lease Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 1,586 | |
2024 | 1,556 | |
2025 | 1,820 | |
2026 | 1,869 | |
2027 | 1,918 | |
Thereafter | 10,674 | |
Total lease payments | 19,423 | |
Less: Effect of discounting to net present value | (8,441) | |
Present value of lease liabilities | 10,982 | |
Current operating lease liabilities | 1,580 | $ 0 |
Non-current operating lease liabilities | 9,402 | $ 0 |
Operating lease liability | $ 10,982 |
Leases - Schedule of Operatin_2
Leases - Schedule of Operating Lease Minimum Payments (Details) $ in Thousands | Dec. 31, 2021 USD ($) |
Leases [Abstract] | |
2022 | $ 1,813 |
2023 | 2,031 |
2024 | 1,981 |
2025 | 1,931 |
2026 | 1,982 |
Thereafter | 11,741 |
Total minimum lease payments | $ 21,479 |
Fair value measurements - Fair
Fair value measurements - Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation (Details) $ in Thousands | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Oct. 05, 2021 conversionRate | Dec. 31, 2020 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and money market funds | $ 121,966 | $ 67,271 | ||
Investments | 35,162 | |||
Contingent value rights | 25,688 | 22,531 | ||
Other current liabilities | 9 | 1,769 | ||
Stonebridge | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Business Combination, Shares Conversion Rate | conversionRate | 0.7840 | |||
Fair Value, Inputs, Level 1 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and money market funds | 121,966 | 67,271 | ||
Investments | 0 | |||
Contingent value rights | 0 | 0 | ||
Other current liabilities | 0 | 0 | ||
Fair Value, Inputs, Level 2 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and money market funds | 0 | 0 | ||
Investments | 35,162 | |||
Contingent value rights | 0 | 0 | ||
Other current liabilities | 0 | 0 | ||
Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and money market funds | 0 | 0 | ||
Investments | 0 | |||
Contingent value rights | 25,688 | 22,531 | ||
Other current liabilities | $ 9 | 1,769 | $ 159 | |
Corporate securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 12,067 | |||
Corporate securities | Fair Value, Inputs, Level 1 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 0 | |||
Corporate securities | Fair Value, Inputs, Level 2 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 12,067 | |||
Corporate securities | Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 0 | |||
Commercial paper | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 21,773 | |||
Commercial paper | Fair Value, Inputs, Level 1 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 0 | |||
Commercial paper | Fair Value, Inputs, Level 2 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 21,773 | |||
Commercial paper | Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 0 | |||
Foreign Government Investments | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 1,322 | |||
Foreign Government Investments | Fair Value, Inputs, Level 1 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 0 | |||
Foreign Government Investments | Fair Value, Inputs, Level 2 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | 1,322 | |||
Foreign Government Investments | Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investments | $ 0 |
Fair value measurements - CVR a
Fair value measurements - CVR and Warrants Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants Liabilities [Roll Forward] | ||
Balance at December 31, 2021 | $ 1,769 | |
Change in fair value of warrants and expiration of Strongbridge private placement warrants | (1,760) | $ 702 |
Balance at December 31, 2022 | 9 | 1,769 |
Fair Value, Inputs, Level 3 [Member] | ||
Warrants Liabilities [Roll Forward] | ||
Balance at December 31, 2021 | 1,769 | 159 |
Assumption of Strongbridge private placement warrants | 908 | |
Change in fair value of warrants and expiration of Strongbridge private placement warrants | (1,760) | 702 |
Balance at December 31, 2022 | 9 | 1,769 |
CVR Liabilities | Fair Value, Inputs, Level 3 [Member] | ||
Contingent Value Rights [Roll Forward] | ||
Balance at December 31, 2021 | 22,531 | |
Change in fair value of CVRs | 3,157 | 0 |
Balance at December 31, 2022 | $ 25,688 | $ 22,531 |
Short-term investments (Details
Short-term investments (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Short-term Investments | $ 0 | $ 35,162,000 |
Amortized Cost | 35,169,000 | |
Gross Unrealized Gains | 2,000 | |
Gross Unrealized Losses | (9,000) | |
Total Fair Value | 35,162,000 | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 21,773,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Total Fair Value | 21,773,000 | |
Corporate securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 12,072,000 | |
Gross Unrealized Gains | 2,000 | |
Gross Unrealized Losses | (7,000) | |
Total Fair Value | 12,067,000 | |
Foreign government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 1,324,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (2,000) | |
Total Fair Value | $ 1,322,000 |
Net loss per common share - Ant
Net loss per common share - Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 38,734,658 | 35,157,496 |
Shares to be issued upon conversion of Convertible Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,416,667 | 15,416,667 |
Vested and unvested stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 9,700,161 | 11,362,336 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,255,560 | 2,005,041 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 8,362,270 | 6,373,452 |
Other Employee Benefit Plans (D
Other Employee Benefit Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Defined Contribution Plan, Matching Contributions | $ 1,700 | $ 700 |
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 100% | |
Deferred compensation, accrued interest rate | 2% | |
Deferred Compensation Arrangement with Individual, Compensation Expense | $ 1,600 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 21% | ||
Operating loss carryforwards | $ 501,400,000 | $ 475,700,000 | |
Operating loss carryforwards, various states | $ 345,300,000 | 309,700,000 | |
Deduction percentage limit for net operating losses | 80% | ||
Federal research income tax credits, gross of valuation allowance | $ 6,700,000 | 5,400,000 | |
State research income tax credits, gross of valuation allowance | 3,100,000 | 2,500,000 | |
Uncertain tax positions | 722,000 | 627,000 | $ 929,000 |
Income tax interest and penalties expense | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal tax benefit at statutory rate | $ (20,178) | $ (25,772) |
State tax benefit, net of federal benefit | (4,325) | (4,422) |
Research and development and orphan drug credits | (320) | (350) |
Uncertain tax positions | 94 | (302) |
Permanent adjustments to expenses | 726 | 1,779 |
Stock-based compensation | 414 | 901 |
Return to provision adjustment | (1,103) | (2,450) |
Statutory tax rate differential | 1,600 | 663 |
Changes in valuation allowance | 21,162 | 29,642 |
Other | 506 | 311 |
Total income tax benefit | $ (1,424) | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | |||
Net operating losses | $ 111,631 | $ 100,790 | |
Federal research and orphan drug credits | 8,836 | 7,184 | |
Stock-based compensation | 5,714 | 3,177 | |
Other temporary differences | 32,977 | 27,094 | |
Deferred Tax Assets, Valuation Allowance | (159,043) | (137,881) | $ (92,493) |
Total assets | 115 | 364 | |
Fixed and intangible assets | (11) | (197) | |
Other deferred tax liabilities | (3,622) | (5,109) | |
Total liabilities | (3,633) | (5,306) | |
Net deferred tax liabilities | $ (3,518) | $ (4,942) |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance Rollfoward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Valuation Allowance [Roll Forward] | ||
Valuation allowance, beginning balance | $ (137,881) | $ (92,493) |
Increase for activity | (21,162) | (45,388) |
Valuation allowance, ending balance | $ (159,043) | $ (137,881) |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Beginning balance - uncertain tax positions | $ 627 | $ 929 |
Increases related to tax positions taken during the current year | 92 | 17 |
Increases/(decreases) related to tax positions taken during the prior year | 3 | |
Increases/(decreases) related to tax positions taken during the prior year | (319) | |
Ending balance - uncertain tax positions | $ 722 | $ 627 |
Uncategorized Items - xers-2022
Label | Element | Value |
CVR Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Contingent Value Rights Outstanding | xers_ContingentValueRightsOutstanding | $ 22,531,000 |