Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 16, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MNKD | ||
Entity Registrant Name | MannKind Corporation | ||
Entity Central Index Key | 0000899460 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity File Number | 000-50865 | ||
Entity Tax Identification Number | 13-3607736 | ||
Entity Address, Address Line One | 1 Casper Street | ||
Entity Address, City or Town | Danbury | ||
Entity Address, State or Province | CT | ||
Entity Address, Postal Zip Code | 06810 | ||
City Area Code | 818 | ||
Local Phone Number | 661-5000 | ||
Entity Common Stock, Shares Outstanding | 270,418,215 | ||
Entity Public Float | $ 1,084,416,366 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Incorporation, State or Country Code | DE | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Firm ID | 34 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | Los Angeles, California | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement (the “Proxy Statement”) for the 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission not later than April 29, 2024 are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Document Financial Statement Error Correction [Flag] | false |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues: | |||
Total revenues | $ 198,962 | $ 99,770 | $ 75,442 |
Expenses: | |||
Cost of goods sold | 20,863 | 16,003 | 16,833 |
Research and development | 31,283 | 19,721 | 12,312 |
Selling | 51,776 | 53,753 | 45,528 |
General and administrative | 42,538 | 37,720 | 31,889 |
Asset impairment | 106 | ||
Loss (gain) on foreign currency transaction | 1,916 | (4,811) | (6,567) |
Loss on purchase commitments | 339 | ||
Total expenses | 190,284 | 163,880 | 122,464 |
Income (loss) from operations | 8,678 | (64,110) | (47,022) |
Other income (expense): | |||
Interest income, net | 6,154 | 2,513 | 112 |
Interest expense on financing liability | (9,825) | (9,758) | (1,373) |
Interest expense | (15,151) | (15,011) | (15,204) |
Interest expense on liability for sale of future royalties | (185) | ||
Loss on available-for-sale securities | (170) | (932) | |
Loss on extinguishment of debt | (17,200) | ||
Other income (expense) | 122 | (102) | (239) |
Total other expense | (19,055) | (23,290) | (33,904) |
Loss before income tax expense | (10,377) | (87,400) | (80,926) |
Income tax expense | (1,561) | ||
Net loss | $ (11,938) | $ (87,400) | $ (80,926) |
Net loss per share - basic | $ (0.04) | $ (0.34) | $ (0.32) |
Net loss per share - diluted | $ (0.04) | $ (0.34) | $ (0.32) |
Weighted average shares used to compute net loss per share - basic | 267,014 | 257,092 | 249,244 |
Weighted average shares used to compute net loss per share - diluted | 267,014 | 257,092 | 249,244 |
Commercial product sales | |||
Revenues: | |||
Total revenues | $ 74,029 | $ 56,247 | $ 39,168 |
Collaborations and services | |||
Revenues: | |||
Total revenues | 52,954 | 27,924 | 36,274 |
Expenses: | |||
Cost of revenue | 41,908 | 41,494 | $ 22,024 |
Royalties | |||
Revenues: | |||
Total revenues | $ 71,979 | $ 15,599 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 238,480 | $ 69,767 |
Short-term investments | 56,619 | 101,079 |
Accounts receivable, net | 14,901 | 16,801 |
Inventory | 28,545 | 21,772 |
Prepaid expenses and other current assets | 34,848 | 25,477 |
Total current assets | 373,393 | 234,896 |
Property and equipment, net | 84,220 | 45,126 |
Goodwill | 1,931 | 2,428 |
Other intangible asset | 1,073 | 1,153 |
Long-term investments | 7,155 | 1,961 |
Other assets | 7,426 | 9,718 |
Total assets | 475,198 | 295,282 |
Current liabilities: | ||
Accounts payable | 9,580 | 11,052 |
Accrued expenses and other current liabilities | 42,036 | 35,553 |
Financing liability — current | 9,809 | 9,565 |
Midcap credit facility - current | 20,000 | |
Liability for sale of future royalties - current | 9,756 | |
Deferred revenue — current | 9,085 | 1,733 |
Recognized loss on purchase commitments — current | 3,859 | 9,393 |
Total current liabilities | 104,125 | 67,296 |
Mann Group convertible note | 8,829 | 8,829 |
Accrued interest - Mann Group convertible note | 56 | 55 |
Financing liability — long term | 94,319 | 94,512 |
Midcap credit facility - long term | 13,019 | 39,264 |
Senior convertible notes | 226,851 | 225,397 |
Liability for sale of future royalties - long term | 136,054 | |
Recognized loss on purchase commitments — long term | 60,942 | 62,916 |
Operating lease liability | 3,925 | 5,343 |
Deferred revenue — long term | 69,794 | 37,684 |
Milestone liabilities | 3,452 | 4,524 |
Total liabilities | 721,366 | 545,820 |
Commitments and contingencies (Note 16) | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2023 and 2022 | ||
Common stock, $0.01 par value - 800,000,000 and 400,000,000 shares authorized as of December 31, 2023 and 2022, respectively, and 270,034,495 and 263,793,305 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 2,700 | 2,638 |
Additional paid-in capital | 2,980,539 | 2,964,293 |
Accumulated deficit | (3,229,407) | (3,217,469) |
Total stockholders' deficit | (246,168) | (250,538) |
Total liabilities and stockholders' deficit | $ 475,198 | $ 295,282 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Undesignated preferred stock, par value | $ 0.01 | $ 0.01 |
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Undesignated preferred stock, shares issued | 0 | 0 |
Undesignated preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 800,000,000 | 400,000,000 |
Common stock, shares issued | 270,034,495 | 263,793,305 |
Common stock, shares outstanding | 270,034,495 | 263,793,305 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss (numerator) | $ (11,938) | $ (87,400) | $ (80,926) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) shares in Thousands, $ in Thousands | Total | Convertible Notes The Mann Group L L C | 2024 Convertible Notes | 2024 Convertible Note Interest | Convertible Note Interest The Mann Group L L C | Common Stock | Common Stock Convertible Notes The Mann Group L L C | Common Stock 2024 Convertible Notes | Common Stock 2024 Convertible Note Interest | Common Stock Convertible Note Interest The Mann Group L L C | Additional Paid-in Capital | Additional Paid-in Capital Convertible Notes The Mann Group L L C | Additional Paid-in Capital 2024 Convertible Notes | Additional Paid-in Capital 2024 Convertible Note Interest | Additional Paid-in Capital Convertible Note Interest The Mann Group L L C | Accumulated Deficit |
Beginning Balance at Dec. 31, 2020 | $ (180,419) | $ 2,421 | $ 2,866,303 | $ (3,049,143) | ||||||||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 242,118 | |||||||||||||||
Net issuance of common stock associated with restricted stock units and stock options | (498) | $ 16 | (514) | |||||||||||||
Net issuance of common stock associated with restricted stock units and stock options (in shares) | 1,572 | |||||||||||||||
Issuance of common stock under employee stock purchase plan | 1,090 | $ 5 | 1,085 | |||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 527 | |||||||||||||||
Stock-based compensation expense | 12,200 | 12,200 | ||||||||||||||
Issuance of common stock pursuant to conversion notes | $ 9,573 | $ 5,000 | $ 427 | $ 38 | $ 17 | $ 2 | $ 9,535 | $ 4,983 | $ 425 | |||||||
Issuance of common stock pursuant to conversion notes (in shares) | 3,830 | 1,667 | 170 | |||||||||||||
Issuance of common stock pursuant to payoff of the 2024 convertible note interest | $ 143 | $ 143 | ||||||||||||||
Issuance of common stock pursuant to payoff of the 2024 convertible note interest (in shares) | 27 | |||||||||||||||
Issuance of at-the-market offering | 1,886 | $ 6 | 1,880 | |||||||||||||
Issuance of at-the-market offering (in shares) | 578 | |||||||||||||||
Issuance costs associated with at-the-market offering | (38) | (38) | ||||||||||||||
Premium on Mann Group convertible note | 22,107 | 22,107 | ||||||||||||||
Issuance of common stock from market price stock purchase | 106 | 106 | ||||||||||||||
Issuance of common stock from market price stock purchase (in shares) | 25 | |||||||||||||||
Issuance of common stock pursuant to a warrant conversion | $ 10 | (10) | ||||||||||||||
Issuance of common stock pursuant to a warrant conversion (shares) | 964 | |||||||||||||||
Net loss | (80,926) | (80,926) | ||||||||||||||
Ending Balance at Dec. 31, 2021 | (209,349) | $ 2,515 | 2,918,205 | (3,130,069) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2021 | 251,478 | |||||||||||||||
Net issuance of common stock associated with restricted stock units and stock options | 319 | $ 22 | 297 | |||||||||||||
Net issuance of common stock associated with restricted stock units and stock options (in shares) | 2,242 | |||||||||||||||
Issuance of common stock under employee stock purchase plan | 2,082 | $ 6 | 2,076 | |||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 686 | |||||||||||||||
Stock-based compensation expense | 13,447 | 13,447 | ||||||||||||||
Issuance of common stock pursuant to conversion notes | $ 9,596 | 674 | $ 39 | $ 2 | $ 9,557 | 672 | ||||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 3,838 | 237 | ||||||||||||||
Issuance of at-the-market offering | 19,790 | $ 51 | 19,739 | |||||||||||||
Issuance of at-the-market offering (in shares) | 5,060 | |||||||||||||||
Issuance costs associated with at-the-market offering | (381) | (381) | ||||||||||||||
Issuance of common stock from market price stock purchase | 684 | $ 3 | 681 | |||||||||||||
Issuance of common stock from market price stock purchase (in shares) | 252 | |||||||||||||||
Net loss | (87,400) | (87,400) | ||||||||||||||
Ending Balance at Dec. 31, 2022 | (250,538) | $ 2,638 | 2,964,293 | (3,217,469) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2022 | 263,793 | |||||||||||||||
Net issuance of common stock associated with restricted stock units and stock options | (10,162) | $ 41 | (10,203) | |||||||||||||
Net issuance of common stock associated with restricted stock units and stock options (in shares) | 4,169 | |||||||||||||||
Issuance of common stock under employee stock purchase plan | 1,668 | $ 5 | 1,663 | |||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 507 | |||||||||||||||
Stock-based compensation expense | 17,649 | 17,649 | ||||||||||||||
Issuance of common stock pursuant to conversion notes | $ 222 | $ 1 | $ 221 | |||||||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 51 | |||||||||||||||
Issuance of at-the-market offering | 6,887 | $ 15 | 6,872 | |||||||||||||
Issuance of at-the-market offering (in shares) | 1,478 | |||||||||||||||
Issuance costs associated with at-the-market offering | (108) | (108) | ||||||||||||||
Issuance of common stock from market price stock purchase | 152 | 152 | ||||||||||||||
Issuance of common stock from market price stock purchase (in shares) | 36 | |||||||||||||||
Net loss | (11,938) | (11,938) | ||||||||||||||
Ending Balance at Dec. 31, 2023 | $ (246,168) | $ 2,700 | $ 2,980,539 | $ (3,229,407) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2023 | 270,034 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (11,938) | $ (87,400) | $ (80,926) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Stock-based compensation | 17,649 | 13,447 | 12,200 |
Write-off of inventory | 4,574 | 2,202 | 1,902 |
Depreciation and amortization | 4,535 | 3,325 | 1,986 |
Amortization of debt discount and issuance costs | 2,085 | 2,092 | 1,709 |
(Gain) loss on foreign currency transaction | 1,916 | (4,811) | (6,567) |
Amortization of right-of-use assets | 1,301 | 2,987 | 1,258 |
Loss on available-for-sale securities | 170 | 932 | |
Interest on liability for sale of future royalties | 185 | ||
Interest on financing liability | 31 | 9,552 | 1,372 |
Net (accretion) amortization of investments | (925) | 707 | 520 |
Other, net | (339) | 17 | |
Loss on extinguishment of debt, net | 17,200 | ||
Asset impairment | 106 | ||
Interest on milestone right | 3,663 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 2,345 | (11,807) | (776) |
Inventory | (11,347) | (5,670) | (4,081) |
Prepaid expenses and other current assets | (9,421) | (15,552) | (360) |
Other assets | 263 | 523 | (138) |
Accounts payable | (1,473) | 4,096 | 1,374 |
Accrued expenses and other current liabilities | 6,606 | (723) | 8,814 |
Deferred revenue | 39,462 | 19,047 | (14,567) |
Recognized loss on purchase commitments | (9,424) | (5,709) | (5,892) |
Operating lease liabilities | (2,385) | (3,309) | (2,135) |
Accrued interest on Mann Group convertible note | (4,919) | ||
Deposits from customer | (4,950) | 4,950 | |
Net cash provided by (used in) operating activities | 34,094 | (80,679) | (61,709) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Proceeds from held-to-maturity debt securities | 119,166 | 107,340 | 59,060 |
Purchase of held-to-maturity debt securities | (79,095) | (74,536) | (196,131) |
Purchase of property and equipment | (42,441) | (7,589) | (11,466) |
Acquisition of V-Go | (15,341) | ||
Proceeds from insurance claim | 382 | ||
Purchase of available-for-sale securities | (5,000) | (3,000) | |
Net cash provided by (used in) investing activities | (1,988) | 4,874 | (151,537) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from sale of future royalties | 150,000 | ||
Issuance costs associated with sale of future royalties | (4,050) | ||
Proceeds from market price stock purchase plan and employee stock purchase plan | 1,820 | 2,766 | 106 |
Payments for taxes related to net issuance of common stock associated with restricted stock units and stock options | (10,162) | 319 | (498) |
Principal payment on financing liability | (189) | (18) | |
Milestone payment | (924) | (1,088) | (5,000) |
Proceeds from Senior convertible notes | 230,000 | ||
Issuance costs associated with Senior convertible notes | (7,268) | ||
Proceeds from the sale-leaseback transaction | 102,250 | ||
Issuance costs associated with at-the-market offering / sale-leaseback transaction | (3,120) | ||
Deposit for the sale-leaseback transaction | (2,000) | ||
Principal payments on Mann Group convertible note | (35,051) | ||
Payment on MidCap credit facility | (6,667) | (10,000) | |
Payment of MidCap credit facility prepayment penalty | (1,000) | ||
Net cash provided by financing activities | 136,607 | 21,388 | 270,267 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 168,713 | (54,417) | 57,021 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 69,767 | 124,184 | 67,163 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 238,480 | 69,767 | 124,184 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | |||
Interest paid in cash | 18,279 | 8,852 | 11,268 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Reclassification of Midcap credit facility from long-term to current | 26,667 | ||
Reclassification of investments from long-term to current | 6,404 | 82,850 | 32,654 |
Non-cash construction in progress, property and equipment | 1,691 | 1,298 | 1,264 |
Right-of-use asset modification | 728 | 3,793 | 278 |
Goodwill adjustment for a net reduction in liabilities | 497 | ||
Receivable for insurance claim on damaged equipment | 445 | ||
Accrued issuance costs associated with liability for sale of future royalties | 325 | ||
Payments on debt and interest through common stock issuance | 222 | 10,270 | 15,143 |
Reclassification of Thirona convertible notes and interest receivable from long-term to current | 7,375 | ||
Issuance of common stock under employee stock purchase plan | 1,090 | ||
Addition of right-of-use-asset | 1,812 | 1,425 | |
Contingent milestone liability | 610 | ||
The Mann Group L L C | |||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Interest on Mann Group convertible note | 224 | 325 | 1,598 |
At The Market Issuance | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from at-the-market-offering | 6,887 | 19,790 | 1,886 |
Issuance costs associated with at-the-market offering / sale-leaseback transaction | $ (108) | $ (381) | $ (38) |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Description of Business | 1. Description of Business Business — MannKind Corporation and its subsidiaries (the “Company”) is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. The Company’s signature technologies, Technosphere dry-powder formulations and Dreamboat inhalation devices, offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation. The Company is currently commercializing Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. The first product to come out of the orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder received approval from the U.S. Food and Drug Administration (“FDA”) in May 2022 for the treatment of pulmonary arterial hypertension (PAH) and for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Company's development and marketing partner, United Therapeutics ("UT") began commercializing Tyvaso DPI in June 2022 and is obligated to pay the Company a royalty on net sales of the product. The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT. Basis of Presentation — The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated. Reclassifications — Certain amounts reported in prior years have been reclassified to conform with the current year presentation. Changes were made to the consolidated statements of cash flows to present the amortization of debt discount and issuance costs and net investment (accretion) amortization separately from amortization and depreciation expense. Additionally, changes were made to our effective income tax rate reconciliation table in Note 18 – Income Taxes to separate officers compensation from permanent items . Segment Information — Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as one segment operating in the United States of America. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Financial Statement Estimates — The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and notes. Actual results could differ from those estimates or assumptions. Management considers many factors in selecting appropriate financial accounting policies, and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. These effects could have a material impact on the estimates and assumptions used in the preparation of the consolidated financial statements. The more significant estimates include revenue recognition, including gross-to-net adjustments, stand-alone selling price considerations for recognition of collaboration revenue, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, stock-based compensation, the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, the valuation allowance recorded against net deferred tax assets, and expected cash flows from royalties received in connection with UT's net revenue for the sale of Tyvaso DPI. Revenue Recognition — The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has two types of contracts with customers: (i) contracts for commercial product sales with wholesale distributors, specialty and retail pharmacies, and durable medical equipment suppliers ("DMEs") and (ii) collaboration arrangements. Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells its products to a limited number of wholesale distributors, specialty and retail pharmacies, and DMEs in the U.S. (collectively, its “Customers”). Wholesale distributors subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty and retail pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company recognizes revenue on product sales to a retail pharmacy as the product is dispensed to patients. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below. Free Goods Program — From time to time, the Company offers programs to potential new patients that allow them to obtain free goods (prescription fills) from a pharmacy. The Company excludes such amounts related to these programs from both gross and net revenue. The cost of product associated with the free goods program is recognized as cost of goods sold in the consolidated statements of operations. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgment is required in estimating gross-to-net adjustments, including historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, claim submission time lags and inventory levels in the distribution channel. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analysis also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the current period estimates of gross-to-net adjustments and therefore, the transaction price was not reduced further during the current period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net revenue from commercial product sales and earnings in the period such variances become known. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company’s current return reserve percentage is estimated to be in the single digits. Adjustments to the returns reserve have been made in the past and may be necessary in the future based on revised estimates to the Company’s assumptions. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase products from the Company. Customers charge the Company for the difference between what they pay for products and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit. Government Rebates — The Company is subject to discount obligations under Medicare and state Medicaid programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Estimates around Medicaid have historically required significant judgment due to timing lags in receiving invoices for claims from states. For Afrezza, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for products that have been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. Payer Rebates — The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates, including estimates for product that has been recognized as revenue, but which remains in the distribution channel, and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with the products that have been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Revenue Recognition — Revenue — Collaborations and Services — The Company enters into licensing, research or other agreements under which the Company licenses certain rights to its product candidates to third parties, conducts research or provides other services to third parties. The terms of these arrangements may include, but are not limited to payment to the Company of one or more of the following: up-front license fees; development, regulatory, and commercial milestone payments; payments for commercial manufacturing and clinical supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract. With respect to the Company's significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the “CSA”), the Company has identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of the product (“Next-Gen R&D Services”); and (3) a material right associated with current and future manufacturing and supply of product (“Manufacturing Services”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services performance obligation as required by ASC 606. Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT. See Note 11 – Collaboration, Licensing and Other Arrangements . If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. For further information, see Note 11 – Collaboration, Licensing and Other Arrangements. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices. Whenever the Company determines that an arrangement should be accounted for over time, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. If these milestones are not considered probable at the inception of the collaboration, the milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is improbable at inception and subsequently deemed probable of achievement, such will be added to the transaction price, resulting in a cumulative adjustment to revenue. If the milestone is achieved after the performance period has been completed and all performance obligations have been delivered, the Company will recognize the milestone payment as revenue in its entirety in the period the milestone was achieved. The Company’s collaboration agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaboration agreements. The Company grants licenses to its intellectual property, supplies raw materials, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaboration agreements must generally be accounted for pursuant to ASC 606. For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception. The Company assessed the CSA agreement with UT and determined that a material right existed for the manufacturing services performance obligation. The transaction price is allocated to the material right as well as the remaining performance obligations in accordance with ASC 606. The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. Revenue Recognition — Royalties — The Company recognizes royalty revenue for a sales-based or usage-based royalty if it is promised in exchange for an intellectual property license. The royalty revenue is recognized as the latter of the subsequent sale of the product occurs or if the performance obligation to which the royalty has been allocated has been satisfied or partially satisfied. The Company’s collaboration agreement with UT entitles it to receive a 10 % royalty on net sales of Tyvaso DPI for the license of the Company’s IP that was considered to be interdependent with the development activities that supported the approval of Tyvaso DPI. Although the Company recognizes a 10 % royalty on net revenue from the sale of Tyvaso DPI as revenue, it will only collect 9 % of future royalties due to its sale of 1 % of future royalties in December 2023 as detailed in Note 16 – Commitments and Contingencies . The Company’s net revenue and cost of revenue and goods sold as shown on the consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Year Ended December 31, 2023 2022 2021 Net revenue: Product revenue (1) $ 126,054 $ 81,073 $ 39,435 Services (2) 929 3,098 36,007 Royalties (3) 71,979 15,599 — Total net revenue $ 198,962 $ 99,770 $ 75,442 _________________________ (1) Amounts represent the net revenue from Afrezza and V-Go sales to wholesalers and specialty pharmacies and Tyvaso DPI to UT. (2) Amounts represent revenue generated from the Company’s collaboration arrangements, including Next-Gen R&D Services (as defined in Note 11) for UT as well as arrangements with other collaboration partners. See Note 11 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Year Ended December 31, 2023 2022 2021 Cost of goods sold and cost of revenue: Product revenue $ 61,989 $ 55,071 $ 16,833 Services 782 2,426 22,024 Total cost of goods sold and cost of revenue $ 62,771 $ 57,497 $ 38,857 The Company follows accounting guidance in measuring revenue and certain judgments affect the application of its revenue policy. For example, in connection with its existing collaboration agreements, the Company has recorded on its consolidated balance sheets short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on the Company’s current project development plan and, if the development plan should change in the future, the Company may recognize a different amount of deferred revenue over the next 12 -month period. Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. Cost of Goods Sold — Cost of goods sold includes material, labor costs and manufacturing overhead. Cost of goods sold also includes a component of current period manufacturing costs in excess of costs capitalized into inventory (“excess capacity costs”). These costs, in addition to the impact of the revaluation of inventory for standard costing, and write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold excludes the cost of insulin purchased under the Company’s Insulin Supply Agreement (the “Insulin Supply Agreement”) with Amphastar Pharmaceuticals, Inc. (“Amphastar”). All insulin inventory on hand was written off and the full purchase commitment contract to purchase future insulin was accrued as a recognized loss on purchase commitments as of the end of 2016. Cost of Revenues – Collaborations and Services — Cost of revenues – for collaborations and services includes material, labor costs, manufacturing overhead, and excess capacity costs. These costs, in addition to the write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of revenues – for collaborations and services also includes the cost of product development. Research and Development ("R&D") — Clinical trial expenses result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials. R&D costs are expensed as incurred. Clinical study and certain research costs are recognized over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Nonrefundable advance payments for services to be received in the future for use in R&D activities are recorded as prepaid assets and expensed in the period when the services are performed. Cash and Cash Equivalents — The Company considers all highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash to be cash equivalents. As of December 31, 2023 and 2022 , cash equivalents were comprised of money market funds, corporate bonds and commercial paper with original maturities less than 90 days from the date of purchase. Held-to-Maturity Investments — The Company’s investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of December 31, 2023 and 2022 , the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company assesses whether it has any intention to sell the investment before maturity, whether any declines in fair value are the result of credit losses, as well as whether there were other-than-temporary impairments associated with the available for sale investment. The Company intends to hold its investments until maturity; therefore, these investments are stated at amortized cost. The investments with maturities less than 12 months are included in short-term investments and investments with maturities in excess of twelve months are included in long-term investments in the consolidated balance sheets. The amortization or accretion of the Company’s investments is recognized as interest income in the consolidated statements of operations. Available-for-Sale Investment — In June 2021, the Company purchased a $ 3.0 million convertible promissory note (the “Thirona convertible note”) issued by Thirona Bio, Inc. (“Thirona”). In January 2022, the Company purchased an additional $ 5.0 million convertible promissory note issued by Thirona. Unless earlier converted into conversion shares pursuant to the note purchase agreement, the aggregate principal of $ 8.0 million and accrued interest shall be due and payable by Thirona on demand by the Company at any time after the maturity date. The Thirona convertible notes were amended in February 2023 to extend the maturity date from December 31, 2022 to June 30, 2024. The Thirona convertible notes are general unsecured obligations of Thirona and accrue interest at a rate of 6 % per annum. The Thirona convertible notes are classified as available-for-sale securities and are included in prepaid expenses and other current assets in the consolidated balance sheets. The Company periodically assesses whether it has any intention to sell the investment, determines the fair value of its available-for-sale investments using level 3 inputs and assesses whether there were other-than-temporary impairments associated with the investment. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized, while unrealized losses related to credit risk are reported through earnings in the period incurred. In June 2021, the Company and Thirona also entered into a collaboration agreement to develop a compound for the treatment of fibrotic lung diseases. See Note 11 – Collaboration, Licensing and Other Arrangements . Concentration of Credit Risk — Financial instruments that potentially subject the Company to concentration of credit risk consisted of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consisted of interest-bearing money market funds and U.S. Treasury securities with original or remaining maturities of 90 days or less at the time of purchase. Investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. The cash equivalents and investments are regularly monitored by management. Accounts Receivable and Allowance for Credit Losses — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for credit losses if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for credit losses. The allowance for expected credit losses is based primarily on past collections experience relative to the length of time receivables are past due. However, when available evidence reasonably supports an assumption that future economic conditions will differ from current and historical payment collections, an adjustment is reflected in the allowance for expected credit losses. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. Pre-Launch Inventory — An improvement to the manufacturing process for the Company’s primary excipient fumaryl diketopiperazine (“FDKP”) was demonstrated to be viable and management expects to realize an economic benefit in the future as a result of such process improvement. Accordingly, the Company is required to assess whether to capitalize inventory costs related to such excipient prior to validation of the improved manufacturing process and adoption of the new supplier. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of modifying the Company’s manufacturing processes, feedback from technical experts and regulatory agencies on the changes being effected and the amount of inventory that is likely to be used in commercial production. The shelf life of the excipient will be determined as part of the validation process; in the interim, the Company must assess the available stability data to determine whether there is likely to be adequate shelf life to support anticipated future sales occurring beyond |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisition | 3. Acquisition In May 2022 , the Company purchased certain assets and assumed certain liabilities associated with the V-Go wearable insulin delivery device from Zealand Pharma A/S and Zealand Pharma US, Inc. (together “Zealand”). Under the terms of the agreement with Zealand, the Company paid up-front consideration of $ 15.3 million for certain assets and assumed liabilities related to V-Go. In addition, the Company will be obligated to make one-time, sales-based milestone payments to Zealand totaling up to a maximum of $ 10.0 million upon the achievement of specified annual revenue milestones between $ 40 million and $ 100 million. The total purchase consideration for V-Go was as follows (in thousands): Fair value of consideration: Amount Cash consideration $ 15,341 Fair value of contingent consideration (1) 610 Total $ 15,951 ___________________________ (1) Subsequent changes in the fair value are reported in general and administrative expenses. See Note 12 – Fair Value of Financial Instruments for subsequent fair value disclosures. The fair value of the contingent milestone liability was estimated using the Monte Carlo simulation method for the calculation of the potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market-based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 2.95 %, dividend yield of 0 %, volatility of 65 %, period of 15 years and credit risk of 12 %. The transaction was accounted for using the acquisition method of accounting, which requires, among other things, the assets acquired and liabilities assumed to be recognized at their respective fair values as of the acquisition date. The excess of the purchase price over those fair values was recorded as goodwill, which will be amortized over a period of 15 years for tax purposes. The estimates and assumptions used include the projected timing and amount of future cash flows and discount rates to reflect the risk inherent in the future cash flows. In May 2023, the Company finalized the fair value for assets acquired and liabilities assumed for V-Go. Inventory of $ 11.2 million consisted of raw materials, semi-finished goods and finished goods. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 inputs not observable in the market. Property and equipment and assumed liabilities were recorded at their carrying amounts which were deemed to approximate their fair values based on level 3 unobservable inputs. The fair values of the right-of-use assets and lease liabilities for assumed operating leases were assessed in accordance with ASC 842, Leases , based on discounted cash flow from lease payments, utilizing the Company’s incremental borrowing rate of 7.25 %. The fair value of the intangible asset was determined by applying the income approach based on significant level 3 unobservable inputs. The income approach estimates fair value based on the present value of cash flow that the assets could be expected to generate in the future. The Company developed internal estimates for expected cash flows in the present value calculation using inputs and significant assumptions that include historical revenues and earnings, long-term growth rate, discount rate, contributory asset charges and future tax rates, among others. The information below reflects the preliminary amounts of identifiable assets acquired and liabilities assumed as of May 31, 2023 (in thousands): Amount Assets: Inventory (1) $ 11,152 Property and equipment 2,921 Goodwill (1) 1,931 Intangible asset - Developed technology 1,200 Operating lease right-of-use assets 1,812 Total assets 19,016 Liabilities: Liabilities assumed (1) 1,253 Operating lease liability 1,812 Total liabilities 3,065 Net assets acquired $ 15,951 ___________________________ (1) Through May 2023, goodwill related to the acquisition of V-Go was adjusted for a reduction in rebate-related liabilities partially offset by a reserve for inventory obsolescence. The Company incurred acquisition-related costs of approximately $ 0.4 million for the year ended December 31, 2022 . There were no acquisition-related costs incurred for the year ended December 31, 2023 . |
Investments
Investments | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of Investments [Abstract] | |
Investments | 4. Investments Cash Equivalents — Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase that are readily convertible into cash. Available-for-Sale Investment — The Thirona convertible notes are classified as available-for-sale securities and are included in prepaid expenses and other current assets in the consolidated balance sheets. Available-for-sale investments are subsequently measured at fair value with realized gains and losses reported in other income (expense) in the consolidated statements of operations. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income (loss) until realized. The Company determines the fair value of its available-for-sale investments using level 3 inputs and evaluates the fair value of its investment in Thirona by applying a Monte Carlo simulation model. For each of the years ended December 31, 2023 and 2022 , the Company recognized $ 0.5 million of interest income on investment. The Company's investment in Thirona is comprised of two notes with aggregate face value of $ 8.0 million and stated interest rate of 6 %. As of December 31, 2023 and 2022 , the fair value of the Company's investment in Thirona was $ 6.9 million and $ 7.1 million, respectively. In addition, the Company determined that there were related credit losses on the investment of $ 0.2 million and $ 0.9 million during the years ended December 31, 2023 and 2022 , respectively, which were recognized in the consolidated statements of operations. No unrealized holding gain or loss was recognized in accumulated other comprehensive income (loss) during the years ended December 31, 2023, 2022,- and 2021. Held-to-Maturity Investments — Investments consist of highly liquid investments that are intended to facilitate liquidity and capital preservation. The amortization or accretion of the Company’s investments is recognized as interest income in the consolidated statements of operations and was approximately $ 1.6 million and $ 0.7 million for the years ended December 31, 2023 and 2022 , respectively. No allowance for credit losses on held-to-maturity securities was required as of December 31, 2023 or 2022. The contractual maturities of the Company’s held-to-maturity investments are summarized below (in thousands): December 31, 2023 December 31, 2022 Amortized Aggregate Amortized Aggregate Due in one year or less (1) $ 115,263 $ 115,374 $ 152,862 $ 156,976 Due after one year through five years 7,155 7,197 1,961 1,948 Total $ 122,418 $ 122,571 $ 154,823 $ 158,924 ___________________________ (1) The investments due in one year or less include cash equivalents of $ 58.6 million as of December 31, 2023 and $ 51.8 million as of December 31, 2022 . The fair value of the cash equivalents, long-term and short-term investments are disclosed below (in millions): December 31, 2023 Investment Level Amortized Cost Gross Unrealized Estimated Commercial bonds and paper Level 2 $ 43.3 $ 0.1 $ 43.4 Money market funds Level 1 69.6 — 69.6 U.S. Treasuries Level 2 9.5 0.1 9.6 Total cash equivalents and investments 122.4 0.2 122.6 Less: cash equivalents ( 58.6 ) — ( 58.6 ) Total Investments $ 63.8 $ 0.2 $ 64.0 December 31, 2022 Investment Level Amortized Cost Gross Unrealized Estimated Commercial bonds and paper Level 2 $ 66.8 $ ( 0.6 ) $ 66.2 Money market funds Level 1 51.8 — 51.8 U.S. Treasuries Level 2 36.3 ( 0.6 ) 35.7 Total cash equivalents and investments 154.9 ( 1.2 ) 153.7 Less: cash equivalents ( 51.8 ) — ( 51.8 ) Total Investments $ 103.1 $ ( 1.2 ) $ 101.9 As of December 31, 2023 , there was $ 0.5 million of accrued interest receivable included in prepaid expense and other current assets in our consolidated balance sheets. As of December 31, 2022 , there was $ 0.6 million of accrued interest receivable and $ 5.1 million of amount receivable on matured investment. |
Accounts Receivable
Accounts Receivable | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Accounts Receivable | 5. Accounts Receivable Accounts receivable, net consists of the following (in thousands): December 31, 2023 December 31, 2022 Accounts receivable – commercial Accounts receivable, gross $ 20,199 $ 19,359 Wholesaler distribution fees and prompt pay discounts ( 2,469 ) ( 2,536 ) Reserve for returns ( 6,215 ) ( 4,108 ) Allowance for credit losses ( 157 ) — Total accounts receivable – commercial, net 11,358 12,715 Accounts receivable – collaborations and services 3,543 4,086 Total accounts receivable, net $ 14,901 $ 16,801 As of December 31, 2023 , the allowances for credit losses and doubtful accounts for commercial accounts receivable of $ 0.2 million was related to $ 0.2 million of accounts receivable for Zealand. As of December 31, 2022, the allowances for credit losses and doubtful accounts for commercial accounts receivable was de minimis . As of December 31, 2023 and 2022 , the Company had three wholesale distributors representing approximately 85 % and 74 % of gross sales and 74 % and 79 % of commercial accounts receivable, respectively. As of December 31, 2023 , there was no allowance for credit losses for accounts receivable for collaborations and services. The Company had one collaboration partner, UT, that comprised 100 % of the collaboration and services net accounts receivable as of December 31, 2023 and approximately 100 % and 98 % of gross revenue from collaborations and services for the years ended December 31, 2023 and 2022, respectively. The Company recognizes revenue net of gross-to-net adjustments. The activities and ending reserve balance consists of the following (in thousands): December 31, 2023 December 31, 2022 Prompt Pay Discount Reserve, Allowance for Wholesale Distribution Fees Beginning balance $ 6,644 $ 4,493 Provisions 18,977 17,471 Deductions ( 16,780 ) ( 15,320 ) Ending balance $ 8,841 $ 6,644 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | 6. Inventories Inventories consist of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 6,262 $ 5,739 Work-in-process 13,646 13,815 Finished goods 8,637 2,218 Total inventory $ 28,545 $ 21,772 Work-in-process and finished goods as of December 31, 2023 and 2022 include conversion costs and exclude the cost of insulin. All insulin inventory on hand was written off and the projected loss on the purchase commitment contract to purchase future insulin was accrued as of the end of 2016. Raw materials inventory included $ 0.8 million of pre-launch inventory as of December 31, 2023 and 2022, which consisted of FDKP received in November 2019. The Company analyzed its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company also performed an assessment of projected sales and evaluated the lower of cost or net realizable value and the potential excess inventory on hand as of December 31, 2023 and 2022. Inventory that was forecasted to become obsolete due to expiration as well as inventory that does not meet acceptable standards is recorded in costs of goods sold in the consolidated statements of operations and a reserve for inventory in our consolidated balance sheets. As a result of this assessment there were inventory write-offs of $ 4.6 million and $ 2.2 million for the years ended December 31, 2023 and 2022 , respectively. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 7. Property and Equipment Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) December 31, 2023 December 31, 2022 Land — $ 875 $ 875 Buildings 39 - 40 17,389 17,389 Building improvements 5 - 40 46,357 38,952 Machinery and equipment 3 - 15 60,410 58,542 Furniture, fixtures and office equipment 5 - 10 3,070 2,976 Computer equipment and software 3 8,658 8,246 Construction in progress — 48,997 16,706 Total property and equipment 185,756 143,686 Less accumulated depreciation ( 101,536 ) ( 98,560 ) Total property and equipment, net $ 84,220 $ 45,126 Depreciation expense related to property and equipment for the years ended December 31, 2023, 2022 and 2021 was $ 4.5 million, $ 3.3 million and $ 2.0 million, respectively. During the years ended December 31, 2023 and 2022 , the Company retired $ 2.1 million and $ 2.4 million, respectively of manufacturing equipment, computer hardware and software, computer equipment, lab equipment, and building improvements, as it was no longer in service. The net book value for the disposed assets during the years ended December 31, 2023 and 2022 was $ 0.6 million and de minimis , respectively. In November 2021 , the Company sold certain land, building and improvements located in Danbury, CT (the “Property”) to an affiliate of Creative Manufacturing Properties (the “Purchaser”) for a sales price of $ 102.3 million, subject to terms and conditions contained in a purchase and sale agreement. Effective with the closing of this transaction, the Company entered into a 20 -year lease agreement with the Purchaser (the “Sale-Leaseback Transaction”). The sale of the Property and subsequent lease did not result in the transfer of control of the Property to the Purchaser; therefore, the Sale-Leaseback Transaction qualified as a failed sale leaseback transaction whereby the lease is accounted for as a finance lease and the Property remains as a long-lived asset of the Company and is depreciated at its remaining useful life of 20 years or less. See Note 16 – Commitments and Contingencies . |
Goodwill and Other Intangible A
Goodwill and Other Intangible Asset | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Asset | 8. Goodwill and Other Intangible Asset Goodwill — Goodwill represents the excess of the purchase price over the identifiable tangible and intangible assets acquired plus liabilities assumed arising from business combinations. The balance of goodwill was approximately $ 1.9 million and $ 2.4 million as of December 31, 2023 and 2022, respectively, as a result of the Company's acquisition of V-Go in May 2022. Through May 2023, goodwill related to the acquisition of V-Go was adjusted for a reduction in rebate-related liabilities partially offset by a reserve for inventory obsolescence. Goodwill is tested at least annually for impairment by assessing qualitative factors in determining whether it is more likely than not that the fair value of net assets is below their carrying amounts. See Note 2 – Summary of Significant Accounting Policies . Other Intangible Asset — Other intangible asset consisted of the following (in thousands): Estimated December 31, 2023 December 31, 2022 Useful Cost Accumulated Net Book Value Cost Accumulated Net Book Value Developed technology 15 $ 1,200 $ ( 127 ) $ 1,073 $ 1,200 $ ( 47 ) $ 1,153 Amortization expense related to the other intangible asset was $ 0.1 million and de minimis for the years ended December 31, 2023 and 2022, respectively. The estimated annual amortization expense for the other intangible asset for the years ended December 31, 2024 through 2028 will be approximately $ 0.1 million per year and $ 0.7 million, thereafter. The Company evaluates its other intangible asset for potential impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. See Note 2 – Summary of Significant Accounting Policies . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 9. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities were comprised of the following (in thousands): December 31, 2023 December 31, 2022 Salary and related expenses $ 19,506 $ 14,906 Discounts and allowances for commercial product sales 9,541 8,504 Accrued interest 2,153 2,201 State income tax liability 1,561 — Deferred lease liability 1,423 1,304 Professional fees 979 1,136 Current portion of milestone rights liability 752 924 Returns reserve for acquired product 601 1,013 Danbury facility buildout 316 846 Other 5,204 4,719 Accrued expenses and other current liabilities $ 42,036 $ 35,553 The provision for discounts and allowances for commercial product sales is reflected as a component of net revenues. The activities and ending balances consisted of the following (in thousands): December 31, 2023 December 31, 2022 Discounts and allowances for commercial product sales: Beginning balance $ 8,504 $ 4,227 Provisions 34,980 23,369 Deductions ( 33,943 ) ( 20,603 ) V-Go opening balance sheet — 1,511 Ending balance $ 9,541 $ 8,504 |
Borrowings
Borrowings | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Borrowings | 10. Borrowings Carrying amount of the Company’s borrowings consisted of the following (in thousands): December 31, 2023 December 31, 2022 Senior convertible notes $ 226,851 $ 225,397 MidCap credit facility 33,019 39,264 Mann Group convertible note 8,829 8,829 Total debt – net carrying amount $ 268,699 $ 273,490 The following table provides a summary of the Company’s principal balance of debt and key terms: Amount Due Terms December 31, 2023 December 31, 2022 Annual Interest Maturity Date Conversion Price Senior convertible notes $ 230.0 million $ 230.0 million 2.50 % March 2026 $ 5.21 MidCap credit facility $ 33.3 million $ 40.0 million one-month 1 % floor) 6.25 %; 8.25 % (1 ) August 2025 N/A Mann Group convertible note $ 8.8 million $ 8.8 million 2.50 % December 2025 $ 2.50 _________________________ (1) In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). The maturities of the Company’s borrowings as of December 31, 2023 are as follows (in thousands): Amounts 2024 $ 20,000 2025 22,163 2026 230,000 Total principal payments 272,163 Unamortized discount and prepayment fee ( 313 ) Debt issuance costs ( 3,151 ) Total debt $ 268,699 Senior convertible notes – In March 2021, the Company issued $ 230.0 million aggregate principal amount of Senior convertible notes in a private offering. The Senior convertible notes were issued pursuant to an indenture, dated March 4, 2021 (the “Indenture”), between the Company and U.S. Bank National Association, as trustee. The Senior convertible notes are general unsecured obligations of the Company and will mature on March 1, 2026 , unless earlier converted, redeemed or repurchased by the Company. The Senior convertible notes will bear cash interest from March 4, 2021 at an annual rate of 2.50 % payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021. The Senior convertible notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding December 1, 2025, only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2021 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock, par value $ 0.01 per share, for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price for the Senior convertible notes on each applicable trading day; (2) during the five business day period after any ten consecutive trading day period in which the trading price (as defined in the Indenture) per $ 1,000 principal amount of the Senior convertible notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the common stock and the conversion rate on each such trading day; (3) if the Company calls such Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date, but only with respect to the Senior convertible notes called (or deemed called) for redemption; or (4) upon the occurrence of specified corporate events as set forth in the Indenture. On or after December 1, 2025 until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at any time, regardless of the foregoing circumstances. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the common stock or a combination of cash and shares of common stock, at the Company’s election, in the manner and subject to the terms and conditions provided in the Indenture. The initial conversion rate is 191.8281 shares of common stock per $ 1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $ 5.21 per share of common stock). The initial conversion price of the Senior convertible notes represents a premium of approximately 30 % to the last reported sale price of the common stock on the Nasdaq Global Market on March 1, 2021. The conversion rate for the Senior convertible notes is subject to adjustment under certain circumstances in accordance with the terms of the Indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date of the Senior convertible notes or if the Company delivers a notice of redemption in respect of the Senior convertible notes, the Company will, in certain circumstances, increase the conversion rate of the Senior convertible notes for a holder who elects to convert its Senior convertible notes in connection with such a corporate event or convert its Notes called for redemption during the related redemption period (as defined in the Indenture), as the case may be. The Company may not redeem the Senior convertible notes prior to March 6, 2024. The Company may redeem for cash all or any portion of the Senior convertible notes, at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of common stock has been at least 130 % of the conversion price for the Senior convertible notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100 % of the principal amount of the Senior convertible notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company elects to redeem less than all of the outstanding Senior convertible notes, at least $ 75.0 million aggregate principal amount of Senior convertible notes must be outstanding and not subject to redemption as of the relevant redemption notice date. No sinking fund is provided for the Senior convertible notes. If the Company undergoes a fundamental change (as defined in the Indenture), then, subject to certain conditions and except as described in the Indenture, holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100 % of the principal amount of the Senior convertible notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Indenture includes customary covenants and sets forth certain events of default after which the Senior convertible notes may be declared immediately due and payable. If certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries) occur, 100 % of the principal of and accrued and unpaid interest on the Senior convertible notes will automatically become due and payable. If an event of default with respect to the Senior convertible notes, other than certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries), occurs and is continuing, the trustee, by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Senior convertible notes by notice to the Company and the trustee, may, and the trustee at the request of such holders shall, declare 100 % of the principal of and accrued and unpaid interest, if any, on all the Senior convertible notes to be due and payable. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company so elects, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture will, for the first 365 days after the occurrence of such an event of default consist exclusively of the right to receive additional interest on the Senior convertible notes as set forth in the Indenture . The Indenture provides that the Company shall not consolidate with or merge with or into, or sell, convey, transfer or lease all or substantially all of the consolidated properties and assets of the Company and its subsidiaries, taken as a whole, to, another person (other than any such sale, conveyance, transfer or lease to one or more of the Company’s direct or indirect wholly owned subsidiaries), unless: (i) the resulting, surviving or transferee person (if not the Company) is a corporation organized and existing under the laws of the United States of America, any State thereof or the District of Columbia, and such corporation (if not the Company) expressly assumes by supplemental indenture all of the Company’s obligations under the Senior convertible notes and the Indenture; and (ii) immediately after giving effect to such transaction, no default or event of default has occurred and is continuing under the Indenture. The Company’s net proceeds from the March 2021 offering were approximately $ 222.7 million, after deducting the initial purchasers’ discounts and commissions and the estimated offering expenses payable by the Company. As of December 31, 2023 and 2022 , the unamortized debt issuance cost was $ 3.1 million and $ 4.6 million, respectively. MidCap credit facility — In August 2019, the Company entered into the MidCap credit facility and borrowed the first advance of $ 40.0 million (“Tranche 1”) in August 2019 and the second advance of $ 10.0 million (“Tranche 2”) in December 2020. In April 2021, $ 10.0 million was prepaid. Under the terms of the MidCap credit facility, a third advance of $ 60.0 million (“Tranche 3”) became available to the Company after the Tyvaso DPI approval by the FDA through June 30, 2022 (see Note 11 – Collaboration, Licensing and Other Arrangements ). The Company did not exercise its right to borrow Tranche 3. The MidCap credit facility has been amended several times, including in April 2021 when the parties agreed to, among other things, (i) increase the amount available under the third advance from $ 25.0 million to $ 60.0 million and extend the date through which the third advance is available to June 30, 2022 , (ii) amend the conditions to the third advance of $60.0 million being available to draw, including certain milestone conditions associated with Tyvaso DPI, (iii) remove the Company’s obligation to issue a warrant to purchase shares of the Company’s common stock upon drawing down the third advance, (iv) extend the interest-only period until September 1, 2023 and extend the maturity date until August 1, 2025 , (v) amend the financial covenant relating to trailing 12 month minimum Afrezza net revenue, (vi) decrease the minimum cash covenant, (vii) decrease the interest rate on any amounts outstanding, now or in the future, under the MidCap credit facility, (viii) permit the Company to make certain acquisitions, subject to requirements, and (ix) permit the Company to make investments of up to an additional $ 9.0 million so long as the Company has $ 90.0 million or more of unrestricted cash and short-term investments following such investment. Concurrent with entering into this amendment, the Company made a $ 10.0 million principal prepayment against outstanding term loans under the MidCap credit facility and paid a related $ 1.0 million exit fee in lieu of the unaccrued portion of the original exit fee and prepayment penalties that would otherwise have been due with respect to the partial prepayment. The prepayment penalty of $ 1.0 million related to the payment of $ 10.0 million was capitalized and is being amortized over the remaining life of the debt. As of December 31, 2023 and 2022 , the unamortized debt discount was $ 0.1 million and $ 0.2 million, respectively, and the unamortized prepayment penalty was $ 0.2 million and $ 0.5 million, respectively. In August 2022, the Company entered into the tenth amendment to the MidCap credit facility to change the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). Tranche 1 and Tranche 2 accrue interest at an annual rate equal to the lesser of (i) 8.25 % and (ii) the one-month SOFR (subject to a one-month SOFR floor of 1.00 %) plus 6.25 %. Interest on each term loan advance is due and payable monthly in arrears. Principal on each term loan advance under Tranche 1 and Tranche 2 are payable in 24 equal monthly installments that began September 1, 2023 , until paid in full on August 1, 2025 . The Company has the option to prepay its existing term loans, in whole or in part, subject to early termination fees in an amount equal to 1.00 % of principal prepaid. The Company’s obligations under the MidCap credit facility are secured by a security interest on substantially all of its assets, including intellectual property. The MidCap credit facility, as amended, contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant relating to trailing twelve month minimum Afrezza net revenue, tested on a monthly basis, unless the Company has $ 90.0 million or more of unrestricted cash and short-term investments. As of December 31, 2023, the Company was in compliance with the financial covenant. The MidCap credit facility also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, listing of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, the agent and the lenders may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the MidCap credit facility. During the existence of an event of default, interest on the term loans could be increased by 2.00 %. Mann Group convertible note — In August 2019, the Company issued a $ 35.0 million note that is convertible into shares of the Company’s common stock at $ 2.50 per share (the “Mann Group convertible note”) as part of a restructuring of its then existing indebtedness to Mann Group. The Mann Group convertible note originally accrued interest at the rate of 7.00 % per year on the principal amount, payable quarterly in arrears on the first day of each calendar quarter beginning October 1, 2019 . In April 2021, the Company repaid the entire principal amount of $ 35.1 million outstanding under the Mann Group non-convertible note, together with all accrued and unpaid interest thereon. On the same date, the Company and Mann Group amended the Mann Group convertible note, pursuant to which the parties agreed to (i) reduce the interest rate from 7.0% to 2.5 % effective on April 22, 2021, and (ii) extend the maturity date from November 3, 2024 to December 31, 2025 . The amendment to the Mann Group convertible note resulted in a debt extinguishment with a substantial premium based on the fair value post extinguishment. The fair value in excess of the face amount of $ 18.4 million contributed to a loss on extinguishment of $ 22.1 million in the consolidated statement of operations for the year ended December 31, 2021 and resulted in a corresponding debt premium of $ 22.1 million which was recognized as additional paid-in capital in the consolidated balance sheet as of December 31, 2021. The accounting for the $ 22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The Company wrote off a de minimis amount of debt issuance cost. The principal and any accrued and unpaid interest under the Mann Group convertible note may be converted, at the option of Mann Group, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at a conversion rate of 400 shares per $ 1,000 of principal and/or accrued and unpaid interest, which is equal to a conversion price of $ 2.50 per share. The conversion rate will be subject to adjustment under certain circumstances described in the Mann Group convertible note. Interest on the convertible note will be payable in kind by adding the amount thereof to the principal amount; provided that with respect to interest accruing from and after January 1, 2021, the Company may, at its option, elect to pay any such interest on any interest payment date, if certain conditions are met, in shares of the Company’s common stock at a price per shall equal to the last reported sale price on the trading day immediately prior to the payment date. Pursuant to the terms of the Mann Group convertible note, Mann Group converted $ 3.0 million of accrued interest and $ 7.0 million of principal into 1.2 million shares and 2.8 million shares, respectively, of the Company’s common stock in the fourth quarter of 2020. During the year ended December 31, 2021, Mann Group converted $ 0.4 million of interest and $ 9.6 million of principal into 4,000,000 shares of common stock. During the year ended December 31, 2022, Mann Group converted $ 10.0 million of principal and capitalized interest into 4,000,000 shares of common stock. In addition, the Company paid $ 0.3 million of interest by issuing the Mann Group 75,487 shares of common stock during the year ended December 31, 2022. During the year ended December 31, 2023, Mann Group converted $ 0.2 million of interest into 50,844 shares of common stock. Amortization of the premium and accretion of debt issuance costs related to all borrowings for the years ended December 31, 2023, 2022 and 2021 are as follows (in thousands): Year Ended December 31, 2023 2022 2021 Amortization of debt discount and prepayment fee $ 423 $ 431 $ 377 Amortization of debt issuance cost 1,454 1,453 1,215 |
Collaboration, Licensing and Ot
Collaboration, Licensing and Other Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration, Licensing and Other Arrangements | 11. Collaboration, Licensing and Other Arrangements Revenue from collaborations and services were as follows (in thousands): Year Ended December 31, 2023 2022 2021 UT CSA Agreement (1) $ 52,025 $ 24,826 $ 267 UT License Agreement (2) 782 2,426 34,145 Cipla License and Distribution Agreement 147 147 147 Vertice Pharma Co-Promotion Agreement — 325 1,147 Other — 200 323 Receptor CLA — — 245 Total revenue from collaborations and services $ 52,954 $ 27,924 $ 36,274 _________________________ (1) Amounts consist of revenue recognized for Manufacturing Services and sales of product to UT for the periods presented. (2) Amounts consist of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented. The activity related to deferred revenue and the related revenue recognized for collaborations and services is as follows (in thousands): December 31, 2023 December 31, 2022 Deferred revenue: Beginning balance $ 39,417 $ 20,370 Additions 92,416 46,971 Revenue — collaborations and services ( 52,954 ) ( 27,924 ) Ending balance $ 78,879 $ 39,417 United Therapeutics License Agreement — In September 2018, the Company and UT entered into an exclusive global license and collaboration agreement (the “UT License Agreement”), pursuant to which UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI. The Company is responsible for manufacturing Tyvaso DPI. Total revenue from UT was as follows (in thousands): Year Ended December 31, 2023 2022 2021 UT Revenue UT CSA Agreement $ 52,025 $ 24,826 $ 267 UT License Agreement 782 2,426 34,145 Royalties — Collaborations (1) 71,979 15,599 — Total revenue from UT $ 124,786 $ 42,851 $ 34,412 _________________________ (1) Amounts consist of royalties associated with the UT License Agreement. The contract assets related to the royalties is included in prepaid expense and other current assets in the consolidated balance sheets . In October 2018, the Company and UT entered into the UT License Agreement for the collaboration and development of Tyvaso DPI. Pursuant to this agreement, the Company receives a 10 % royalty on net sales of Tyvaso DPI. In December 2023, the Company sold a 1 % royalty on future net sales of Tyvaso DPI to a royalty purchaser, with the Company retaining a 9 % royalty. In August 2021, the Company and UT entered into the CSA, pursuant to which the Company is responsible for manufacturing and supplying to UT, and UT is responsible for purchasing from the Company on a cost-plus basis. In addition, UT is responsible for supplying treprostinil at its expense in quantities necessary to enable the Company to manufacture Tyvaso DPI as required by the CSA. The activities and deliverables under the CSA and UT License Agreement resulted in distinct performance obligations which include: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI ("R&D Services and License"); (2) development activities for the next generation of Tyvaso DPI ("Next-Gen R&D Services"); and (3) a material right associated with current and future commercial manufacturing and supply of product ("Manufacturing Services and Product Sales"). There have been various amendments to the UT License Agreement and the CSA since inception. As amended, the term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) UT provides notice to the Company at least 24 months in advance of such renewal that UT does not wish to renew the CSA or (ii) the Company provides notice to UT at least 48 months in advance of such renewal that the Company does not wish to renew the CSA . The Company and UT each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party. The Company accounted for the contract modification as if it were part of the existing contract since the amendment modified the scope and price of the CSA by extending the term and increasing the occupancy rate. The effect of the modification on the transaction price and on the measure of progress is recognized as an adjustment to revenue as of the date of modification. The modification did not result in a change in the activities and deliverables under the CSA. In December 2022, the Company and UT agreed to fund an additional $ 39.5 million to support capital and continuous improvement activities and $ 2.3 million in the development of alternative manufacturing processes. The Company determined that the capital and continuous improvements should be combined with the manufacturing services performance obligation and the alternative manufacturing processes should be combined with the Next-Gen R&D Services. The total revised anticipated cash flows of $ 722.3 million from the transaction was allocated to the three distinct performance obligations as follows (dollars in millions). Anticipated Cash Flow Revenue Allocation Recognition Method Progress Measure Revenue Total anticipated cash flow (1) $ 722.3 Distinct Performance Obligation R&D Services and License $ — Over time Ratably Aug 2021 - Oct 2021 Next-Gen R&D Services $ 10.0 Over time Input % of completion of costs Manufacturing Services and (2) $ 712.3 Point in time Transfer of control __________________________ (1) The total anticipated cash flow includes a transaction price of $ 120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA. (2) The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $ 220.8 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received. As of December 31, 2023 , deferred revenue consisted of $ 77.5 million, of which $ 8.9 million was classified as current and $ 68.6 million was classified as long-term on the consolidated balance sheet. As of December 31, 2022 , deferred revenue consisted of $ 37.9 million, of which $ 1.6 million was classified as current and $ 36.3 million was classified as long-term on the consolidated balance sheet. The increase in deferred revenue is primarily related to the capital improvements for the expansion of our manufacturing facility. The Company determined that the revenue recognition associated with the capital improvements should be combined with the manufacturing services performance obligation. Thirona Collaboration Agreement — In June 2021, the Company and Thirona entered into a collaboration agreement to evaluate the therapeutic potential of Thirona’s compound for the treatment of pulmonary fibrosis. If initial studies are promising, the Company can exercise certain rights to seek a full license to the compound for clinical development and commercialization. The parties will perform their respective obligations and provide reasonable support for research, clinical development and regulatory strategy. The collaboration agreement was accounted for under ASC 808, Collaborative Agreements ; however, no consideration was exchanged between the parties. The costs incurred by the Company were expensed as R&D in the consolidated statements of operations. On February 28, 2023, the collaboration agreement was amended to extend the term through June 2024. In accordance with the amendment, the Company agreed to fund a minimum of $ 1.1 million to be expended on a revised development plan prepared by Thirona, of which $ 0.7 million was funded during the year ended December 31, 2023. Biomm Supply and Distribution Agreement — In May 2017, the Company and Biomm S.A. (“Biomm”) entered into a supply and distribution agreement for the commercialization of Afrezza in Brazil. Under this agreement, Biomm was responsible for pursuing regulatory approvals of Afrezza in Brazil, including from the Agência Nacional de Vigilância Sanitária (“ANVISA”) and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos (“CMED”), both of which were received. Biomm commenced product sales in January 2020. No shipments of product were made to Biomm during the year ended December 31, 2023, 2022 or 2021. Cipla License and Distribution Agreement — In May 2018 , the Company and Cipla Ltd. (“Cipla”) entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $ 2.2 million nonrefundable license fee. Under the terms of the agreement, Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla. The Company has the potential to receive an additional regulatory milestone payment, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. The nonrefundable licensing fee was recorded in deferred revenue and is being recognized in net revenue – collaborations over 15 years, representing the estimated period to satisfy the performance obligation. The additional milestone payments represent variable consideration for which the Company has not recognized any revenue because of the uncertainty of obtaining marketing approval. As of December 31, 2023 , the deferred revenue balance was $ 1.4 million, of which $ 0.2 million was classified as current and $ 1.2 million was classified as long term in the consolidated balance sheets. As of December 31, 2022 , the deferred revenue balance was $ 1.5 million, of which $ 0.1 million is classified as current and $ 1.4 million is classified as long term in the consolidated balance sheets. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 12. Fair Value of Financial Instruments The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement. The Company uses the exit price method for estimating the fair value of loans for disclosure purposes. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy, as follows: Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. The carrying amounts reported in the consolidated financial statements for cash, accounts receivable, accounts payable, and accrued expenses and other current liabilities (excluding the Milestone Rights liability) approximate their fair value due to their relatively short maturities. The fair value of the Senior convertible notes, MidCap credit facility, Mann Group convertible note, Milestone Rights liability and Financing liability are disclosed below. Financial Liabilities — The following tables set forth the fair value of the Company’s financial instruments (Level 3 in the fair value hierarchy) (in millions): December 31, 2023 Fair Value Carrying Amount Significant Financial liabilities: Senior convertible notes (1) $ 226.9 $ 231.3 MidCap credit facility (2) 33.0 35.5 Mann Group convertible note (3) 8.8 14.4 Milestone rights (4) 3.9 11.9 Contingent milestone liability (5) 0.3 0.3 Financing liability (6) 104.1 106.8 _________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 11 %, volatility of 62.7 % and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 224.1 million and $ 238.9 million, respectively. (2) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 12 %. A change in yield of + or – 2 % would result in a fair value of $ 35.0 million and $ 36.0 million, respectively. (3) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 13 % and volatility of 62.7 % to the straight note and a binomial option pricing model for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 14.2 million and $ 14.7 million, respectively. (4) Fair value was determined by applying a Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 3.88 %, dividend yield of 0 %, volatility of 50 %, period of 8 years and credit risk of 17 % . (5) Fair value was determined by using the Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 4.01 %, dividend yield of 0 %, volatility of 43 %, period of 15 years and credit risk of 17 % . (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. December 31, 2022 Fair Value Carrying Value Significant Financial liabilities: Senior convertible notes (1) $ 225.4 $ 253.9 MidCap credit facility (2) 39.3 41.1 Mann Group convertible note (3) 8.8 20.8 Milestone rights (4) 4.8 12.6 Contingent milestone liability (5) 0.6 1.0 Financing liability (6) 104.1 103.2 __________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 13 %, volatility of 75.8 % and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 245.0 million and $ 263.4 million, respectively. (2) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 12 %. A change in yield of + or – 2 % would result in a fair value of $ 40.0 million and $ 42.4 million, respectively. (3) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 13 % and volatility of 77.8 % to the straight note and a binomial option pricing model for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 20.5 million and $ 21.2 million, respectively. (4) Fair value was determined by applying a Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 3.99 %, dividend yield of 0 %, volatility of 50 %, period of 8 years and credit risk of 17 % . (5) Fair value was determined by using the Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market-based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 4.01 %, dividend yield of 0 %, volatility of 43 %, period of 15 years and credit risk of 17 % . (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 10 %. Milestone Rights Liability — The fair value measurement of the Milestone Rights liability is sensitive to the discount rate and the timing of achievement of milestones. The Company utilized Monte-Carlo Simulation Method to simulate the Afrezza net sales under a neutral framework to estimate the payment. The Company then discounted the future expected payments at cost of debt with a term equal to the simulated time to payout based on cumulative sales. See Note 16 – Commitments and Contingencies . Contingent milestone liability — The acquisition of V-Go in May 2022 resulted in a contingent milestone liability which could result in obligations to the seller if certain revenue thresholds are met. The initial fair value of the contingent milestone liability was recorded as an adjustment to the purchase price. Subsequent changes in the fair value are reported in general and administrative expenses. See Note 3 – Acquisition. Financing Liability — The Sale-Leaseback Transaction in November 2021 resulted in a financing liability. See Note 16 – Commitments and Contingencies . |
Common and Preferred Stock
Common and Preferred Stock | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Common and Preferred Stock | 13. Common and Preferred Stock In May 2023, the Company’s stockholders, upon recommendation of the Company’s board of directors, approved an amendment to our Amended and Restated Certificate of Incorporation to increase the authorized number of shares of common stock from 400,000,000 shares to 800,000,000 shares. The Company is authorized to issue 800,000,000 shares of common stock, par value $ 0.01 per share, and 10,000,000 shares of undesignated preferred stock, par value $ 0.01 per share, issuable in one or more series as designated by the Company’s board of directors. No other class of capital stock is authorized. As of December 31, 2023 and 2022 , 270,034,495 and 263,793,305 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding. In February 2018, the Company entered into a controlled equity offering sales agreement (the “CF Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company’s common stock having an aggregate offering price of up to $ 50.0 million or such other amount as may be permitted by the Sales Agreement. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. During the year ended December 31, 2023, the Company sold 1,478,090 shares of common stock at a weighted average purchase price of $ 4.66 per share for gross proceeds of approximately $ 6.9 million pursuant to the CF Sales Agreement. During the year ended December 31, 2022, the Company sold 5,059,856 shares of common stock at a weighted average purchase price of $ 3.91 per share for gross proceeds of approximately $ 19.8 million pursuant to the CF Sales Agreement. During the year ended December 31, 2021, the Company sold an aggregate of 578,063 shares of the Company’s common stock at a weighted average purchase price of $ 3.26 per share for aggregate gross proceeds of approximately $ 1.9 million pursuant to the Sales Agreement. In February 2021, the Company converted $ 5.0 million principal amount of 2024 convertible notes into 1,666,667 shares of the Company’s common stock. In October 2021, MidCap exercised 1,171,614 and 111,853 warrants issued in association with Tranches 1 and 2, respectively, under the MidCap credit facility, as amended, to purchase an aggregate of 1,283,467 shares of the Company’s common stock through a cashless exercise that resulted in the net issuance of 964,113 shares. See Note 10 – Borrowings . In December 2021, the Mann Group converted $ 0.4 million of interest and $ 9.6 million of principal into 4.0 million shares of common stock. See Note 10 – Borrowings. During the year ended December 31, 2021, the Company received $ 0.1 million from the market price stock purchase plan (“MPSPP”) for 25,000 shares of common stock. During the year ended December 31, 2022, Mann Group converted $ 10.0 million of principal and capitalized interest into 4,000,000 shares of common stock. In addition, the Company paid interest by issuing Mann Group 75,487 shares of common stock. During the year ended December 31, 2022, the Company received $ 0.7 million from the MPSPP for 252,176 shares of common stock. During the year ended December 31, 2023, the Company paid interest on the Mann Group convertible note by issuing 50,844 shares of common stock. During the year ended December 31, 2023, the Company received $ 0.2 million from the MPSPP for 36,004 shares of common stock. Subsequent to December 31, 2023 , the Company received $ 1.4 million from the MPSPP for 416,099 shares of common stock. For shares of common stock issued pursuant to the Company's 2004 employee stock purchase plan ("ESPP"), see Note 15 – Stock Award Plans . |
Earnings Per Common Share ("EPS
Earnings Per Common Share ("EPS") | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Earnings Per Common Share ("EPS") | 14. Earnings per Common Share (“EPS”) Basic EPS excludes dilution for potentially dilutive securities and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted EPS reflects the potential dilution under the treasury method that could occur if securities or other contracts to issue common stock were exercised or converted into common stock and the if-converted method for convertible debt securities. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted EPS as they would be antidilutive. The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts): Year Ended December 31, 2023 2022 2021 EPS — basic and diluted: Net loss (numerator) $ ( 11,938 ) $ ( 87,400 ) $ ( 80,926 ) Weighted average common shares (denominator) 267,014 257,092 249,244 Net loss per share $ ( 0.04 ) $ ( 0.34 ) $ ( 0.32 ) Common shares issuable represents incremental shares of common stock which consist of stock options, restricted stock units, warrants, and shares that could be issued upon conversion of the Senior convertible notes and the Mann Group convertible notes. Potentially dilutive securities outstanding which were considered antidilutive are summarized as follows (in shares): Year Ended December 31, 2023 2022 2021 Senior convertible notes 44,120,463 44,120,463 44,120,463 RSUs and Market RSUs (1) 7,855,144 18,886,710 7,609,025 Common stock options and PNQs 8,400,611 9,074,587 10,655,146 Mann Group convertible notes 3,370,000 3,370,000 7,370,000 Employee stock purchase plan — — 243,375 Total shares 63,746,218 75,451,760 69,998,009 _________________________ (1) Market RSUs issued in 2021, 2022, and 2023 are included at the share delivery of 0 %, 140 %, and 0 %, respectively, in accordance with a valuation assessment obtained as of December 31, 2023. |
Stock Award Plans
Stock Award Plans | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Award Plans | 15. Stock Award Plans In May 2023, the Company’s stockholders, upon recommendation of the Company’s board of directors, approved an amendment to the Company’s 2018 Equity Incentive Plan (the "2018 Plan") to increase the number of shares of common stock that may be issued under the 2018 Plan by 25,000,000 shares. Effective upon the approval of the 2018 Plan by the Company’s stockholders in May 2018, no additional awards have been or may be granted under the 2013 Equity Incentive Plan (the "2013 Plan"). Any Prior Plans’ (as defined below) returning shares will increase the number of shares issuable under the 2018 Plan. The Prior Plans’ returning shares are shares subject to outstanding stock awards granted under the 2013 Plan or the 2004 Equity Incentive Plan (collectively, “Prior Plans”) that, from and after the effective date of the 2018 Plan, (i) expire or terminate for any reason prior to exercise or settlement, (ii) are forfeited, cancelled or otherwise returned to the Company because of the failure to meet a contingency or condition required for the vesting of such shares, or (iii) other than with respect to outstanding stock options and stock appreciation rights granted under the Prior Plans with an exercise or strike price of at least 100 % of the fair market value of the underlying common stock on the date of grant, are reacquired or withheld (or not issued) by the Company to satisfy a tax withholding obligation in connection with a stock award. The 2018 Plan provides for the granting of stock awards including stock options and restricted stock units to employees, directors and consultants. The Company’s board of directors or its compensation committee determines eligibility, vesting schedules and criteria, and exercise prices for stock awards granted under the 2018 Plan. Options and restricted stock unit awards under the 2018 Plan, or the Prior Plans expire not more than ten years from the date of the grant and are exercisable upon vesting. Stock options that vest over time generally vest over four years . Current time-based vesting stock option grants vest and become exercisable at the rate of 25 % after one year and ratably on a monthly basis over a period of 36 months thereafter. The Company also issues PNQ awards with performance conditions. For PNQs, the Company evaluates the probability that the performance conditions will be met and estimates the service period for recognition of the associated expense. RSUs with time-based vesting generally vest at a rate of 25 % per year over four years with consideration satisfied by service to the Company. Certain RSUs issued to nonemployee directors vest immediately upon grant, but the underlying shares of common stock will not be delivered until there is a separation of service such as resignation, retirement or death. The Company also issued Market RSUs. The grant date fair value and the effect of the market conditions was estimated using a Monte Carlo valuation. Market RSUs issued during the year ended December 31, 2023 had a grant date fair value of $ 9.40 per share and will vest on July 15, 2026 provided that the closing price of the Company’s common stock on such vesting date is not less than the closing price on July 1, 2023. The fair value of the Market RSUs was determined using a share price of $ 4.55 , risk-free interest rate of 4.19 %, volatility of 74 %, and a dividend yield of 0 %. The number of shares delivered on the vesting date is determined by the percentile ranking of MannKind total shareholder return (TSR) over the period from July 1, 2023 until June 30, 2026 relative to the TSR of the Russell 3000 Pharmaceutical & Biotechnology Index over the same period, as follows: less than 25 th percentile= 0 % of target, 25 th percentile= 50 % of target, 50 th percentile= 100 % of target, 75 th percentile= 200 % of target, 90 th percentile or higher= 300 % maximum. Payout values will be interpolated between the percentile rankings above. The resulting stock-based compensation expense will be recognized over the service period regardless of whether the market conditions are achieved, as long as the service condition is satisfied. The following table summarizes information about the Company’s stock-based award plans as of December 31, 2023: Outstanding Outstanding Shares Available 2013 Equity Incentive Plan 2,966,524 — — 2018 Equity Incentive Plan 5,434,087 12,363,934 26,374,063 Total 8,400,611 12,363,934 26,374,063 Share-based payment transactions are recognized as compensation cost based on the fair value of the instrument on the date of grant. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options. The expected term of an option granted is based on combining historical exercise data with expected weighted time outstanding. Expected weighted time outstanding is calculated by assuming the settlement of outstanding awards is at the midpoint between the remaining weighted average vesting date and the expiration date. The Company recognizes forfeitures as they occur. During the years ended December 31, 2023, 2022 and 2021 , the Company recorded RSU and option-based stock compensation expense of $ 17.0 million, $ 12.8 million and $ 11.5 million, respectively, and employee stock purchase plan compensation of $ 0.6 million, $ 0.6 million and $ 0.7 million, respectively. Total stock-based compensation expense recognized in the consolidated statements of operations is included in the following categories (in thousands): Year Ended December 31, 2023 2022 2021 Cost of goods sold $ 1,589 $ 329 $ 407 Cost of revenue — collaborations and services 897 1,425 1,708 Research and development 1,442 1,044 614 Selling 2,291 1,194 2,578 General and administrative 11,430 9,455 6,893 Total $ 17,649 $ 13,447 $ 12,200 The following table summarizes information relating to stock options: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2023 9,074,587 $ 3.06 5.10 $ 29,512 Granted — — Exercised ( 445,376 ) 1.57 Forfeited ( 3,420 ) 2.53 Expired ( 225,180 ) 30.97 Outstanding as of December 31, 2023 8,400,611 $ 2.39 4.07 $ 15,153 Exercisable as of December 31, 2023 7,938,892 $ 2.40 4.12 $ 14,450 There were no options granted in the years ended December 31, 2023 and 2022. Total fair value of stock options vested during the years ended December 31, 2023, 2022 and 2021 was $ 2.8 million, $ 3.2 million and $ 2.3 million, respectively. The total intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 1.3 million, $ 2.4 million and $ 1.7 million, respectively. Intrinsic value is measured using the fair market value at the date of exercise for options exercised or as of December 31 for outstanding options, less the applicable exercise price. Cash received from the exercise of options during the years ended December 31, 2023, 2022 and 2021 was approximately $ 1.2 million, $ 3.0 million and $ 1.0 million, respectively. As of December 31, 2023, 2022 and 2021 , the Company recognized $ 0.3 million, $ 0.1 million and $ 0.1 million, respectively, of compensation costs related to the performance-based stock options. As of December 31, 2023 and 2022 , there were zero and $ 0.2 million, respectively of unrecognized compensation costs related to performance-based stock options subject to performance conditions. The following table summarizes information relating to restricted stock units: Number of Weighted Outstanding as of January 1, 2023 11,838,329 $ 3.65 Granted 7,531,650 5.17 Vested ( 6,053,264 ) 3.41 Forfeited ( 952,781 ) 4.80 Outstanding as of December 31, 2023 12,363,934 4.61 Total fair value of restricted stock units vested during the years ended December 31, 2023, 2022 and 2021 was $ 20.6 million, $ 4.4 million and $ 6.7 million, respectively. Intrinsic value of restricted stock units vested is measured using the closing share price on the day prior to the vest date. The total grant date fair value of restricted stock units outstanding as of December 31, 2023, 2022 and 2021 was $ 57.0 million, $ 43.2 million and $ 19.3 million, respectively. As of December 31, 2023 , there was $ 0.6 million of unrecognized compensation expense related to options and PNQs and $ 16.4 million of unrecognized compensation expense related to restricted stock units and market-based stock units, which are expected to be recognized over the weighted average period of 0.24 to 2.11 years. The Company evaluates stock awards with performance conditions as to the probability that the performance conditions will be met and uses that information to estimate the date at which those performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. Employee Stock Purchase Plan The Company provides all employees, including executive officers, the ability to purchase common stock at a discount under the ESPP. The ESPP is designed to comply with Section 423 of the Internal Revenue Code and provides all employees with the opportunity to purchase up to $ 25,000 worth of common stock (based on the undiscounted fair market value at the commencement of the offering period) each year at a purchase price that is the lower of 85 % of the fair market value of the common stock on either the date of purchase or the commencement of the offering period. An employee may not purchase more than 5,000 shares of common stock on any purchase date. The executives’ rights under the ESPP are the same as those of all other employees. In May 2023, the Company’s stockholders, upon recommendation of the Company’s board of directors, approved an amendment to the Company’s ESPP to increase the number of shares of common stock authorized for issuance under the ESPP by an additional 3,000,000 shares. The Company issued 0.5 million, 0.7 million and 0.5 million shares of common stock pursuant to the ESPP for the years ended December 31, 2023, 2022 and 2021 , respectively. There were approximately 2.9 million shares of common stock available for issuance under the ESPP as of December 31, 2023 . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Guarantees and Indemnifications — In the ordinary course of its business, the Company makes certain indemnities, commitments and guarantees under which it may be required to make payments in relation to certain transactions. The Company, as permitted under Delaware law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal and therefore has not recorded any liability for these indemnities in the consolidated balance sheets. The Company accrues for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable and the amount can be reasonably estimated. No such losses have been recorded to date. Litigation — The Company is subject to legal proceedings and claims which arise in the ordinary course of its business. As of December 31, 2023 , the Company was in the process of settling an ordinary course litigious matter. Although the Company disagrees with the claims asserted, the Company has accrued a settlement amount of $ 0.2 million, which it believes will resolve the matter. The amount is included in accrued expenses and other current liabilities in the consolidated balance sheets, and in other income (expense) in the consolidated statements of operations. The Company does not anticipate the final disposition of any additional matters will have a material adverse effect on the results of operations, financial position or cash flows of the Company and no additional accruals have been recorded. The Company maintains liability insurance coverage to protect the Company’s assets from losses arising out of or involving activities associated with ongoing and normal business operations. The Company records a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company’s policy is to accrue for legal expenses in connection with legal proceedings and claims as they are incurred. Contingencies — Milestone Rights — In July 2013, the Company entered into the Milestone Rights Agreement with the Original Milestone Purchasers, pursuant to which the Company granted the Milestone Rights to receive payments up to $ 90.0 million upon the occurrence of specified strategic and sales milestones, of which $ 55.0 million remains payable to the Milestone Purchasers upon achievement of such milestones as of December 31, 2023. The Milestone Rights Agreement includes customary representations and warranties and covenants by the Company, including restrictions on transfers of intellectual property related to Afrezza. The Milestone Rights are subject to acceleration in the event the Company transfers its intellectual property related to Afrezza in violation of the terms of such agreement. During the second quarters of 2023 and 2022, the Company achieved Afrezza net sales milestones as specified by the Milestone Rights and the portion of the $ 5.0 million payments that related to the Milestone Rights liability on our consolidated balance sheets was approximately $ 0.9 million and $ 1.1 million for the payments made in 2023 and 2022, respectively, and represented the fair value as determined in 2013 (the most recent measurement date). As of December 31, 2023, the remaining Milestone Rights liability balance was $ 3.9 million and consisted of $ 0.8 million of current liability, which was presented as accrued expenses and other current liabilities, and $ 3.1 million of long-term liability, which was presented as milestone liabilities in our consolidated balance sheets. As of December 31, 2022, the remaining Milestone Rights liability balance was $ 4.8 million and consisted of $ 0.9 million of current liability and $ 3.9 million of long-term liability. The value of the Milestone Rights liability was based on initial fair value estimates calculated using the income approach and reduced by milestone achievement payments made. Liability for Sale of Future Royalties — On December 27, 2023 (the “Inception Date”), the Company executed a Purchase and Sale Agreement (the “PSA”) with Sagard Healthcare Partners Funding Borrower SPE 2, LP (“Sagard”). Pursuant to the PSA, Sagard paid the Company $ 150.0 million (the “Upfront Proceeds”), net of $ 0.4 million in reimbursements of Sagard’s fees and expenses (the “Reimbursements”), for the purchase of a 1 % royalty on future net sales of Tyvaso DPI by UT under the terms of the LCA (the “Sagard Royalty”). Sagard will also pay the Company a milestone of $ 50.0 million if net sales of Tyvaso DPI meet or exceed $ 1.9 billion for any twelve consecutive months on or prior to December 31, 2026 (“Net Sales Threshold A”), or a milestone of $ 45.0 million if net Sales Threshold A is not met and net sales of Tyvaso DPI meet or exceed $ 2.3 billion for any twelve consecutive months on or prior to September 30, 2027 (“Net Sales Threshold B”), resulting in a purchase price not to exceed $ 200.0 million (the “Purchase Price”). If Net Sales Thresholds A and B are not met and net sales of Tyvaso DPI meet or exceed $ 3.5 billion for any calendar year after September 30, 2027, no royalties will be payable to Sagard for the remainder of that year. The PSA applies to net sales of Tyvaso DPI generated during October 1, 2023 (the “Commencement Date”) through December 31, 2042 (the “Termination Date”) and will automatically terminate upon payment of the final royalty owed to Sagard thereafter. Upon the Termination Date, ownership of the Sagard Royalty will revert to the Company. Given the Company’s continuing involvement with the generation of Tyvaso DPI revenue under the LCA and CSA, which includes the Company’s supply and manufacture of Tyvaso DPI, and the Company’s retention and associated defense and maintenance obligations of the intellectual property required in the manufacture of Tyvaso DPI, the Upfront Proceeds were recorded as a liability for sale of future royalties (the “Royalty Liability”) on the consolidated balance sheets, and any proceeds from future milestones will be added to the Royalty Liability balance upon receipt. Although the Company is not obligated to repay any portion of the Purchase Price to Sagard, the Royalty Liability under the PSA is secured by a security interest granted to Sagard in the underlying 1 % royalty rights and any proceeds therefrom. As a result of the PSA, transaction costs totaling $ 4.4 million (including the Reimbursements) (the "Transaction Costs") are reported net of the Royalty Liability balance and amortized to interest expense in the consolidated statements of operations over the life of the PSA using the effective interest method. The Company will continue to recognize the full 10 % of future royalty revenues in its consolidated statements of operations, with the Sagard Royalty being non-cash revenue for the Company. As royalty payments are remitted to Sagard, the balance of the Royalty Liability will be effectively repaid as it is amortized over the life of the PSA. To amortize the Royalty Liability, the Company estimated the total amount of future royalty payments to be made to Sagard over the life of the PSA. The excess of those future estimated royalty payments over the Purchase Price proceeds received is recognized in the consolidated statements of operations as non-cash interest expense over the life of the PSA utilizing an imputed effective interest rate. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate may vary during the term of the agreement depending on a number of factors, including the amount and timing of forecasted royalty payments which affects the timing and ultimate amount of reductions to the liability. The Company will evaluate the effective interest rate periodically based on its forecasted royalty payments utilizing the prospective method. The Company periodically assesses the forecasted royalty payments using a combination of historical results, internal projections and forecasts from external sources, which are level 3 inputs. The carrying value of the Royalty Liability approximates fair value as of December 31, 2023 and is based on current estimates of future royalties expected to be remitted to Sagard over the term of the agreement. To the extent such payments, or the timing of such payments, are materially different than original estimates, the Company will prospectively adjust the effective interest rate and amortization of the Royalty Liability. The Company’s effective annual interest rate on the Royalty Liability was approximately 11.1 % during the period of the Inception Date through December 31, 2023, during which time the Company recorded $ 0.2 million in non-cash interest expense and de minimis amortization of the Transaction Costs in the consolidated statements of operations. Non-cash revenue recognized by the Company during the period of the Commencement Date through December 31, 2023 was $ 2.1 million and is payable to Sagard by UT. Sale-Leaseback Transaction — In November 2021, the Company sold the Property to the Purchaser for a sales price of $ 102.3 million, subject to terms and the conditions contained in a purchase and sale agreement. See Note 7 – Property and Equipment. Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser entered into a lease agreement (the “Lease”), pursuant to which the Company leased the Property from the Purchaser for an initial term of 20 years, with four renewal options of five years each. The total annual rent under the Lease starts at approximately $ 9.5 million per year, subject to a 50% rent abatement during the first year of the Lease, and will increase annually by (i) 2.5% in the second through fifth year of the Lease and (ii) 3% in the sixth and each subsequent year of the Lease, including any renewal term. The Company is responsible for payment of operating expenses, property taxes and insurance for the Property. The Purchaser will hold a security deposit of $ 2.0 million during the Lease term. Pursuant to the terms of the Lease, the Company has four options to repurchase the Property, in 2026, 2031, 2036 and 2041, for the greater of (i) $ 102.3 million and (ii) the fair market value of the Property. Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser also entered into a right of first refusal agreement (the “ROFR”), pursuant to which the Company has a right to re-purchase the Property from the Purchaser in accordance with terms and conditions set forth in the ROFR. Specifically, if the Purchaser receives, and is willing to accept, a bona fide purchase offer for the Property from a third-party purchaser, the Company has certain rights of first refusal to purchase the Property on the same material terms as proposed in such bona fide purchase offer. As of December 31, 2023, the related financing liability was $ 104.1 million, which was recognized in the Company’s consolidated balance sheet and of which $ 94.3 million was long-term and $ 9.8 million was current. As of December 31, 2022, the related financing liability was $ 104.1 million, of which $ 94.5 million was long-term and $ 9.6 million was current. Cash paid for interest on the financing liability totaled $ 9.6 million during each of the years ended December 31, 2023 and 2022. Financing liability information was as follows (dollars in thousands): December 31, 2023 December 31, 2022 Weighted average remaining lease term (in years) 17.8 18.8 Weighted average discount rate 9.0 % 9.0 % Year Ended December 31, 2023 2022 2021 Interest expense on financing liability $ 9,825 $ 9,758 $ 1,373 The Company's remaining financing liability payments were as follows (in thousands): December 31, 2023 2024 $ 10,018 2025 10,269 2026 10,533 2027 10,849 2028 11,174 Thereafter 177,278 Total 230,121 Interest payments ( 123,318 ) Debt issuance costs ( 2,675 ) Total financing liability $ 104,128 Commitments — In July 2014, the Company entered into the Insulin Supply Agreement with Amphastar pursuant to which Amphastar manufactures for and supplies to the Company certain quantities of recombinant human insulin for use in Afrezza. Under the terms of the Insulin Supply Agreement, Amphastar is responsible for manufacturing the insulin in accordance with the Company’s specifications and agreed-upon quality standards. On December 22, 2023, the Company and Amphastar amended the Insulin Supply Agreement to extend the term, restructure the annual purchase commitments and include a capacity fee for certain future periods. The Company's remaining purchase commitments and estimated capacity fee liability as of December 31, 2023, as well as pre-amendment purchase commitments as of September 30, 2023, were as follows (€ in millions): December 31, 2023 September 30, 2023 Remaining Purchase Commitments Estimated Capacity Fees Remaining Purchase Commitments 2023 — — 2.4 2024 2.9 — 14.6 2025 — 1.5 15.5 2026 (1) 4.2 2.0 19.4 2027 6.0 1.0 9.2 2028 6.0 1.0 — 2029 6.0 1.0 — 2030 6.0 1.0 — 2031 8.0 0.5 — 2032 8.0 0.5 — 2033 8.0 0.5 — 2034 4.4 0.5 — Total 59.5 9.5 61.1 __________________________ (1) If there is a delay in the availability of insulin with FDA approved inclusion bodies and supply does not begin in 2026 as currently expected, the Company will incur a capacity fee of € 750,000 per quarter that the product is not available for purchase. Pursuant to the amendment, the term of the Insulin Supply Agreement expires on the later of December 31, 2034 or until the completion of the total remaining purchase commitment quantities, unless terminated earlier, and can be renewed for additional, successive two-year terms upon 12 months’ written notice given prior to the end of the initial term or any additional two-year term. The Company and Amphastar each have normal and customary termination rights, including termination for a material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, the Company may terminate the Insulin Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days’ prior written notice to Amphastar if a controlling regulatory authority withdraws approval for Afrezza, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Insulin Supply Agreement require the Company to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. The Company periodically reviews the terms of the long-term Insulin Supply Agreement and assesses the need for any accrual for estimated losses, such as lower of cost or net realizable value that will not be recovered by future product sales. The recognized loss on purchase commitments of $ 64.8 million and $ 72.3 million is included in our consolidated balance sheets as of December 31, 2023 and 2022, respectively, and is reduced as inventory items are received or such liability is extinguished. As a result of the increase in future cash flows for the excess capacity fees and extended term included in the amendment of the Insulin Supply Agreement, the Company analyzed the need for additional estimated losses and concluded that an increase in the recognized loss on purchase commitments was not required as the net realizable value of inventory resulting from the purchase commitment was in excess of the carrying value. Increases in costs associated with the amendment will be recognized through inventory as incurred. Vehicle Leases – During the second quarter of 2018, the Company entered into a master lease agreement with Enterprise Fleet Management Inc. The monthly payment inclusive of maintenance fees, insurance and taxes is approximately $ 0.1 million. The lease expense is included in selling expenses in the consolidated statements of operations. Office Leases — In May 2017, the Company executed an office lease with Russell Ranch Road II LLC for the Company’s corporate offices in Westlake Village, California, which was renewed in April 2022. Pursuant to the renewal, the monthly lease payments of $ 79,543 began in February 2023 and are subject to 3 % annual increases, plus the estimated cost of maintaining the property and common areas by the landlord, and are further subject to a six-month base rent concession beginning February 2023. The Company is also entitled to a one-time allowance up to $ 0.9 million as reimbursement for tenant improvements or the purchase of furniture, fixtures or equipment. Of the $ 0.9 million allowance, an amount up to $ 0.7 million may be applied as an additional base rent concession. The Company has no further right to extend the lease term beyond July 31, 2028. In May 2022, the Company assumed certain leased real property (the “Marlborough Lease”) in connection with the V-Go acquisition. The Marlborough Lease pertains to certain premises in a building located in Marlborough, Massachusetts. The monthly payments of $ 28,895 began in June 2022, subject to approximately 3 % annual increases through February 28, 2026. The Company also acquired rights to a manufacturing service agreement where V-Go is manufactured using Company-owned equipment located at the manufacturing facility. The Company determined that this arrangement results in an embedded lease which granted the Company exclusive use of space within the manufacturing facility. The Company assessed the embedded lease cost to be $ 14,370 per month through February 28, 2026. Lease information was as follows (dollars in thousands): December 31, 2023 December 31, 2022 Operating lease right-of-use assets (1) $ 4,685 $ 6,714 Operating lease liability-current (2) $ 1,423 $ 1,304 Operating lease liability-long-term 3,925 5,343 Total $ 5,348 $ 6,647 Weighted average remaining lease term (in years) 3.7 4.6 Weighted average discount rate 7.3 % 7.3 % __________________________ (1) Operating right-of-use assets related to vehicles, offices and the manufacturing facility are included in other assets in the consolidated balance sheets. (2) Operating lease liability – current are included in accrued expenses and other current liabilities in the consolidated balance sheets. Year Ended December 31, 2023 2022 2021 Operating lease costs $ 1,675 $ 1,525 $ 863 Variable lease costs 104 274 515 Cash paid 1,068 1,823 1,867 The Company's future minimum office and vehicle lease payments were as follows (in thousands): December 31, 2023 2024 $ 1,496 2025 1,861 2026 1,140 2027 1,072 2028 643 Total 6,212 Interest expense ( 864 ) Total operating lease liability $ 5,348 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 17. Employee Benefit Plans The Company administers a defined contribution 401(k) savings retirement plan for its employees. The Company may make discretionary matching contributions. For the years ended December 31, 2023, 2022 and 2021 , the Company matched each participant’s deferral at the rate of 50 % of each participant’s deferral up to the first 10 % of compensation. Participants hired after March 31, 2021 became vested in Company contributions at 100 % after two years of service. Participants are vested in Company contributions at 50 % after one year of service and are 100 % vested after two years of service. The Company’s total discretionary matching contributions were $ 2.9 million, $ 1.8 million and $ 1.5 million for the years ended December 31, 2023, 2022 and 2021 , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 18. Income Taxes Loss from continuing operations before provision for income taxes for the Company’s domestic and international operations was as follows (in thousands): Year Ended December 31, 2023 2022 2021 United States $ ( 10,377 ) $ ( 87,400 ) $ ( 80,926 ) Foreign — — — Loss before provision for income taxes $ ( 10,377 ) $ ( 87,400 ) $ ( 80,926 ) As of December 31, 2023 , the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. The Company has incurred operating losses since inception. Accordingly, the net deferred tax assets have been fully reserved. The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2023 2022 2021 Current U.S. federal $ — $ — $ — U.S. state 1,555 — — Non-U.S. — — — Total current 1,555 — — Deferred U.S. federal ( 190 ) ( 5,606 ) ( 5,170 ) U.S. state 7,002 ( 4,334 ) ( 14,461 ) Non-U.S. — — — Total deferred 6,812 ( 9,940 ) ( 19,631 ) Valuation allowance (6,806 ) 9,940 19,631 Net deferred 6 — — Total $ 1,561 $ — $ — Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. A valuation allowance is established when uncertainty exists as to whether all or a portion of the net deferred tax assets will be realized. Components of the net deferred tax assets are approximately as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 506,641 $ 542,537 Research and development credits 77,007 78,804 Capitalized research costs 14,225 4,369 Milestone Rights 1,006 1,331 Accrued expenses 3,760 2,675 Loss on purchase commitment 22,806 23,117 Non-qualified stock option expense 3,559 7,686 Capitalized patent costs 6,720 8,058 Other 3,405 3,204 Lease liability 1,280 1,624 Interest expense limitation 2,782 10,991 Depreciation 21,134 22,157 Deferred product revenue and costs 346 370 Sale of future royalties 34,848 - Total deferred tax assets 699,519 706,923 Valuation allowance ( 698,228 ) ( 705,034 ) Net deferred tax assets $ 1,291 $ 1,889 Deferred tax liabilities: Right of use asset $ ( 1,121 ) $ ( 1,640 ) Other prepaids ( 176 ) ( 249 ) Total deferred tax liabilities ( 1,297 ) ( 1,889 ) Net deferred tax assets $ ( 6 ) $ — The Company’s effective tax rate differs from the statutory federal income tax rate as follows: Year Ended December 31, 2023 2022 2021 Federal tax benefit rate 21.0 % 21.0 % 21.0 % State tax expense (net of federal benefit) - 11.8 % 0.0 % 0.0 % Permanent items - 2.8 % - 0.1 % - 4.4 % Officers compensation - 35.3 % - 1.1 % 0.0 % Stock based compensation - 5.6 % 0.4 % 0.3 % Tax attribute expirations 0.4 % - 13.2 % - 5.9 % Valuation allowance 9.1 % - 7.2 % - 11.2 % Other deferred adjustments 10.0 % 0.2 % 0.2 % Effective income tax rate - 15.0 % 0.0 % 0.0 % As of December 31, 2023 and 2022, management assessed the realizability of deferred tax assets. Management evaluated the need for an amount of any valuation allowance for deferred tax assets on a jurisdictional basis. This evaluation utilizes the framework contained in ASC 740, Income Taxes, wherein management analyzes all positive and negative evidence available at the balance sheet date to determine whether all or some portion of our deferred tax assets will not be realized. Under this guidance, a valuation allowance must be established for deferred tax assets when it is more likely than not (a probability level of more than 50 percent) that they will not be realized. In assessing the realization of the Company's deferred tax assets, the Company considers all available evidence, both positive and negative. In concluding on the evaluation, management placed significant emphasis on guidance in ASC 740, which states that “a cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome.” Based upon available evidence as of December 31, 2023, it was concluded on a more-likely-than-not basis that all deferred tax assets were not realizable. Accordingly, a valuation allowance of $ 698.2 million has been recorded to offset these deferred tax assets. During the years ended December 31, 2023 and 2022, the change in valuation allowance was $ 6.8 million and $ 9.9 million, respectively. As of December 31, 2023 , the Company had federal and state net operating loss carryforwards of approximately $ 2.0 billion and $ 1.3 billion available, respectively, to reduce future taxable income. $ 494.0 million of the federal losses do not expire and the remaining federal losses have started expiring, beginning in the current year through various future dates. Pursuant to IRC Sections 382 and 383, annual use of the Company’s federal and California net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. As a result of the Company's initial public offering, an ownership change within the meaning of IRC Section 382 occurred in August 2004. As a result, federal net operating loss and credit carryforwards of approximately $ 105.8 million are subject to an annual use limitation of approximately $ 13.0 million. The annual limitation is cumulative and therefore, if not fully utilized in a year can be utilized in future years in addition to the Section 382 limitation for those years. We have completed a Section 382 analysis beginning from the date of our initial public offering through December 31, 2023, to determine whether additional limitations may be placed on the net operating loss carryforwards and other tax attributes, and no additional changes in ownership that met Section 382 study ownership change threshold has been identified through December 31, 2023. There is a risk that changes in ownership may occur in tax years after December 31, 2023. If a change in ownership were to occur, our net operating loss carryforwards and other tax attributes could be further limited or restricted. If limited, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, related to the Company’s operations in the U.S. will not impact the Company’s effective tax rate. As of December 31, 2023 , the Company had $ 54.2 million of U.S. federal research and development credits which expire beginning in 2024 , and $ 22.8 million of state research and development credits. The Company also had two types of credits in Connecticut of which $ 19.8 million do not expire and the $ 1.1 million of the R&D credit expired at the end of 2023 . The Company files U.S. federal and state income tax returns in jurisdictions with varying statutes of limitations. In the normal course of business the Company is subject to examination by taxing authorities throughout the country. These audits could include examining the timing and amount of deductions, the allocation of income among various tax jurisdictions and compliance with federal, state, and local tax laws. The Company's tax years since 2018 remain subject to examination by federal, state and foreign tax authorities. A reconciliation of beginning and ending amounts of unrecognized tax benefits was as follows (in thousands): Year Ended December 31, 2023 2022 2021 Unrecognized Tax Benefit Beginning of Year $ 268,902 $ 268,902 $ 268,902 Gross increases for tax positions of prior years — — — Gross decreases for tax positions of current year — — — Settlements — — — Lapse of statute of limitations — — — End of Year $ 268,902 $ 268,902 $ 268,902 As of December 31, 2023, 2022 and 2021, the Company has not recognized a liability for unrecognized tax benefits. If any were recognized, it would affect the Company’s effective tax rate. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the years ended December 31, 2023, 2022 and 2021 , the Company did no t recognize any interest and/or penalties. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Business | Business — MannKind Corporation and its subsidiaries (the “Company”) is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. The Company’s signature technologies, Technosphere dry-powder formulations and Dreamboat inhalation devices, offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation. The Company is currently commercializing Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. The first product to come out of the orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder received approval from the U.S. Food and Drug Administration (“FDA”) in May 2022 for the treatment of pulmonary arterial hypertension (PAH) and for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Company's development and marketing partner, United Therapeutics ("UT") began commercializing Tyvaso DPI in June 2022 and is obligated to pay the Company a royalty on net sales of the product. The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT. |
Basis of Presentation | Basis of Presentation — The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). |
Principles of Consolidation | Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated. |
Reclassifications | Reclassifications — Certain amounts reported in prior years have been reclassified to conform with the current year presentation. Changes were made to the consolidated statements of cash flows to present the amortization of debt discount and issuance costs and net investment (accretion) amortization separately from amortization and depreciation expense. Additionally, changes were made to our effective income tax rate reconciliation table in Note 18 – Income Taxes to separate officers compensation from permanent items . |
Segment Information | Segment Information — Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as one segment operating in the United States of America. |
Financial Statement Estimates | Financial Statement Estimates — The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and notes. Actual results could differ from those estimates or assumptions. Management considers many factors in selecting appropriate financial accounting policies, and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. These effects could have a material impact on the estimates and assumptions used in the preparation of the consolidated financial statements. The more significant estimates include revenue recognition, including gross-to-net adjustments, stand-alone selling price considerations for recognition of collaboration revenue, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, stock-based compensation, the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, the valuation allowance recorded against net deferred tax assets, and expected cash flows from royalties received in connection with UT's net revenue for the sale of Tyvaso DPI. |
Revenue Recognition | Revenue Recognition — The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has two types of contracts with customers: (i) contracts for commercial product sales with wholesale distributors, specialty and retail pharmacies, and durable medical equipment suppliers ("DMEs") and (ii) collaboration arrangements. |
Revenue Recognition - Net Revenue - Commercial Product Sales | Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells its products to a limited number of wholesale distributors, specialty and retail pharmacies, and DMEs in the U.S. (collectively, its “Customers”). Wholesale distributors subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty and retail pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company recognizes revenue on product sales to a retail pharmacy as the product is dispensed to patients. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below. Free Goods Program — From time to time, the Company offers programs to potential new patients that allow them to obtain free goods (prescription fills) from a pharmacy. The Company excludes such amounts related to these programs from both gross and net revenue. The cost of product associated with the free goods program is recognized as cost of goods sold in the consolidated statements of operations. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgment is required in estimating gross-to-net adjustments, including historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, claim submission time lags and inventory levels in the distribution channel. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analysis also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the current period estimates of gross-to-net adjustments and therefore, the transaction price was not reduced further during the current period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net revenue from commercial product sales and earnings in the period such variances become known. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company’s current return reserve percentage is estimated to be in the single digits. Adjustments to the returns reserve have been made in the past and may be necessary in the future based on revised estimates to the Company’s assumptions. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase products from the Company. Customers charge the Company for the difference between what they pay for products and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit. Government Rebates — The Company is subject to discount obligations under Medicare and state Medicaid programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Estimates around Medicaid have historically required significant judgment due to timing lags in receiving invoices for claims from states. For Afrezza, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for products that have been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. Payer Rebates — The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates, including estimates for product that has been recognized as revenue, but which remains in the distribution channel, and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with the products that have been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. |
Revenue Recognition- Net Revenue - Collaborations and Services | Revenue Recognition — Revenue — Collaborations and Services — The Company enters into licensing, research or other agreements under which the Company licenses certain rights to its product candidates to third parties, conducts research or provides other services to third parties. The terms of these arrangements may include, but are not limited to payment to the Company of one or more of the following: up-front license fees; development, regulatory, and commercial milestone payments; payments for commercial manufacturing and clinical supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract. With respect to the Company's significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the “CSA”), the Company has identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of the product (“Next-Gen R&D Services”); and (3) a material right associated with current and future manufacturing and supply of product (“Manufacturing Services”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services performance obligation as required by ASC 606. Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT. See Note 11 – Collaboration, Licensing and Other Arrangements . If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. For further information, see Note 11 – Collaboration, Licensing and Other Arrangements. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices. Whenever the Company determines that an arrangement should be accounted for over time, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. If these milestones are not considered probable at the inception of the collaboration, the milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is improbable at inception and subsequently deemed probable of achievement, such will be added to the transaction price, resulting in a cumulative adjustment to revenue. If the milestone is achieved after the performance period has been completed and all performance obligations have been delivered, the Company will recognize the milestone payment as revenue in its entirety in the period the milestone was achieved. The Company’s collaboration agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaboration agreements. The Company grants licenses to its intellectual property, supplies raw materials, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaboration agreements must generally be accounted for pursuant to ASC 606. For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception. The Company assessed the CSA agreement with UT and determined that a material right existed for the manufacturing services performance obligation. The transaction price is allocated to the material right as well as the remaining performance obligations in accordance with ASC 606. The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. Revenue Recognition — Royalties — The Company recognizes royalty revenue for a sales-based or usage-based royalty if it is promised in exchange for an intellectual property license. The royalty revenue is recognized as the latter of the subsequent sale of the product occurs or if the performance obligation to which the royalty has been allocated has been satisfied or partially satisfied. The Company’s collaboration agreement with UT entitles it to receive a 10 % royalty on net sales of Tyvaso DPI for the license of the Company’s IP that was considered to be interdependent with the development activities that supported the approval of Tyvaso DPI. Although the Company recognizes a 10 % royalty on net revenue from the sale of Tyvaso DPI as revenue, it will only collect 9 % of future royalties due to its sale of 1 % of future royalties in December 2023 as detailed in Note 16 – Commitments and Contingencies . The Company’s net revenue and cost of revenue and goods sold as shown on the consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Year Ended December 31, 2023 2022 2021 Net revenue: Product revenue (1) $ 126,054 $ 81,073 $ 39,435 Services (2) 929 3,098 36,007 Royalties (3) 71,979 15,599 — Total net revenue $ 198,962 $ 99,770 $ 75,442 _________________________ (1) Amounts represent the net revenue from Afrezza and V-Go sales to wholesalers and specialty pharmacies and Tyvaso DPI to UT. (2) Amounts represent revenue generated from the Company’s collaboration arrangements, including Next-Gen R&D Services (as defined in Note 11) for UT as well as arrangements with other collaboration partners. See Note 11 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Year Ended December 31, 2023 2022 2021 Cost of goods sold and cost of revenue: Product revenue $ 61,989 $ 55,071 $ 16,833 Services 782 2,426 22,024 Total cost of goods sold and cost of revenue $ 62,771 $ 57,497 $ 38,857 The Company follows accounting guidance in measuring revenue and certain judgments affect the application of its revenue policy. For example, in connection with its existing collaboration agreements, the Company has recorded on its consolidated balance sheets short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on the Company’s current project development plan and, if the development plan should change in the future, the Company may recognize a different amount of deferred revenue over the next 12 -month period. |
Milestone Payments | Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. |
Cost of Goods Sold | Cost of Goods Sold — Cost of goods sold includes material, labor costs and manufacturing overhead. Cost of goods sold also includes a component of current period manufacturing costs in excess of costs capitalized into inventory (“excess capacity costs”). These costs, in addition to the impact of the revaluation of inventory for standard costing, and write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold excludes the cost of insulin purchased under the Company’s Insulin Supply Agreement (the “Insulin Supply Agreement”) with Amphastar Pharmaceuticals, Inc. (“Amphastar”). All insulin inventory on hand was written off and the full purchase commitment contract to purchase future insulin was accrued as a recognized loss on purchase commitments as of the end of 2016. |
Cost of Revenues | Cost of Revenues – Collaborations and Services — Cost of revenues – for collaborations and services includes material, labor costs, manufacturing overhead, and excess capacity costs. These costs, in addition to the write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of revenues – for collaborations and services also includes the cost of product development. |
Research and Development | Research and Development ("R&D") — Clinical trial expenses result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials. R&D costs are expensed as incurred. Clinical study and certain research costs are recognized over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Nonrefundable advance payments for services to be received in the future for use in R&D activities are recorded as prepaid assets and expensed in the period when the services are performed. |
Cash and Cash Equivalents | Cash and Cash Equivalents — The Company considers all highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash to be cash equivalents. As of December 31, 2023 and 2022 , cash equivalents were comprised of money market funds, corporate bonds and commercial paper with original maturities less than 90 days from the date of purchase. |
Held-to-Maturity Investments | Held-to-Maturity Investments — The Company’s investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of December 31, 2023 and 2022 , the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company assesses whether it has any intention to sell the investment before maturity, whether any declines in fair value are the result of credit losses, as well as whether there were other-than-temporary impairments associated with the available for sale investment. The Company intends to hold its investments until maturity; therefore, these investments are stated at amortized cost. The investments with maturities less than 12 months are included in short-term investments and investments with maturities in excess of twelve months are included in long-term investments in the consolidated balance sheets. The amortization or accretion of the Company’s investments is recognized as interest income in the consolidated statements of operations. |
Available-for-Sale Investment | Available-for-Sale Investment — In June 2021, the Company purchased a $ 3.0 million convertible promissory note (the “Thirona convertible note”) issued by Thirona Bio, Inc. (“Thirona”). In January 2022, the Company purchased an additional $ 5.0 million convertible promissory note issued by Thirona. Unless earlier converted into conversion shares pursuant to the note purchase agreement, the aggregate principal of $ 8.0 million and accrued interest shall be due and payable by Thirona on demand by the Company at any time after the maturity date. The Thirona convertible notes were amended in February 2023 to extend the maturity date from December 31, 2022 to June 30, 2024. The Thirona convertible notes are general unsecured obligations of Thirona and accrue interest at a rate of 6 % per annum. The Thirona convertible notes are classified as available-for-sale securities and are included in prepaid expenses and other current assets in the consolidated balance sheets. The Company periodically assesses whether it has any intention to sell the investment, determines the fair value of its available-for-sale investments using level 3 inputs and assesses whether there were other-than-temporary impairments associated with the investment. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized, while unrealized losses related to credit risk are reported through earnings in the period incurred. In June 2021, the Company and Thirona also entered into a collaboration agreement to develop a compound for the treatment of fibrotic lung diseases. See Note 11 – Collaboration, Licensing and Other Arrangements . |
Concentration of Credit Risk | Concentration of Credit Risk — Financial instruments that potentially subject the Company to concentration of credit risk consisted of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consisted of interest-bearing money market funds and U.S. Treasury securities with original or remaining maturities of 90 days or less at the time of purchase. Investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. The cash equivalents and investments are regularly monitored by management. |
Accounts Receivable and Allowance for Credit Loss | Accounts Receivable and Allowance for Credit Losses — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for credit losses if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for credit losses. The allowance for expected credit losses is based primarily on past collections experience relative to the length of time receivables are past due. However, when available evidence reasonably supports an assumption that future economic conditions will differ from current and historical payment collections, an adjustment is reflected in the allowance for expected credit losses. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. |
Pre Launch Inventory | Pre-Launch Inventory — An improvement to the manufacturing process for the Company’s primary excipient fumaryl diketopiperazine (“FDKP”) was demonstrated to be viable and management expects to realize an economic benefit in the future as a result of such process improvement. Accordingly, the Company is required to assess whether to capitalize inventory costs related to such excipient prior to validation of the improved manufacturing process and adoption of the new supplier. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of modifying the Company’s manufacturing processes, feedback from technical experts and regulatory agencies on the changes being effected and the amount of inventory that is likely to be used in commercial production. The shelf life of the excipient will be determined as part of the validation process; in the interim, the Company must assess the available stability data to determine whether there is likely to be adequate shelf life to support anticipated future sales occurring beyond the expected adoption date of the new raw material. If management is aware of any specific material risks or contingencies other than the normal regulatory reporting process, or if the criteria for capitalizing inventory produced prior to adoption are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as R&D expense in the period incurred. |
Inventories | Inventories — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company uses a contract manufacturing organization outside of the U.S. for certain stages of V-Go inventory. The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value. The Company analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company performs an assessment of projected sales and evaluates the lower of cost or net realizable value and the potential excess inventory on hand at the end of each reporting period. |
Property and Equipment | Property and Equipment — Property and equipment is recorded at historical cost, net of accumulated depreciation. Depreciation expense is recorded over the assets’ useful lives on a straight-line basis. See Note 7 – Property and Equipment . |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets — Long-lived assets include property and equipment, operating lease right-of-use assets and other intangible assets. The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Assets are considered to be impaired if the carrying value is considered to be unrecoverable. If the Company believes an asset to be impaired, the impairment recognized is the amount by which the carrying value of the asset exceeds the fair value of the asset. Fair value is determined using the market, income or cost approaches as appropriate for the asset. Any write-downs are treated as permanent reductions in the carrying amount of the asset and recognized as an operating loss. |
Acquistitions | Acquisitions — The Company first determines whether a set of assets acquired constitute a business and should be accounted for as a business combination. If the assets acquired do not constitute a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by means of the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process R&D (“IPR&D”) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination (including the assumption of an acquiree’s liability arising from an acquisition it consummated prior to the Company’s acquisition) are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies have been resolved. The resulting changes in fair values are recorded in earnings. In contrast, asset acquisitions are accounted for by using a cost accumulation and allocation model. Under this model, the cost of the acquisition is allocated to the assets acquired and liabilities assumed. IPR&D projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated. See Note 3 – Acquisition . |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets — The fair value of acquired intangible assets is determined using an income-based approach referred to as the excess earnings method utilizing Level 3 fair value inputs. Market participant valuations assume a global view considering all potential jurisdictions and indications based on discounted after-tax cash flow projections, risk adjusted for estimated probability of technical and regulatory success. The Company tests for impairment annually on a reporting unit basis, at the beginning of the Company’s fourth fiscal quarter and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying amount. To the extent the carrying amount of a reporting unit is less than its estimated fair value, an impairment charge will be recorded. Finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life. Estimated useful lives are determined considering the period assets are expected to contribute to future cash flows. Finite-lived intangible assets are tested for impairment when facts or circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds the projected undiscounted pretax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value (discounted after-tax cash flows) is recognized. |
Recognized Loss on Purchase Commitments | Recognized Loss on Purchase Commitments — The Company reviews the terms of the long-term supply agreements and assesses the need for any accrual for estimated losses, such as lower of cost or net realizable value, that will not be recovered by future product sales. The recognized loss on purchase commitments is reduced as inventory items are received or as the liability is extinguished. See Note 16 – Commitments and Contingencies. |
Milestone Rights Liability | Milestone Rights Liability — In July 2013, in conjunction with the execution of a (now repaid) loan agreement with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”), the Company entered into a Milestone Rights Purchase Agreement (the “Milestone Rights Agreement”) pursuant to which the Company issued certain milestone rights to Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÀRL, (the “Original Milestone Purchasers”). The foregoing milestone rights provided the Original Milestone Purchasers certain rights to receive payments of up to $ 90.0 million upon the occurrence of specified strategic and Afrezza sales milestones, $ 55.0 million of which remains payable as of December 31, 2023, upon achievement of such milestones (collectively, the “Milestone Rights”). In December 2021, the Milestone Rights were purchased by Barings Global Special Situations Credit Fund 4 (Delaware), L.P. and Barings Global Special Situations Credit 4 (LUX) S.ar.l. (together the “Milestone Purchasers”). As a result, the Milestone Purchasers have assumed the obligations of the Original Milestone Purchasers and are now entitled to all rights under the Milestone Rights Agreement. The Milestone Rights liability is reported at fair value at the date of the agreement which is periodically offset against payments. See Note 12 – Fair Value of Financial Instruments . The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s consolidated statements of operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event. See Note 9 – Accrued Expenses and Other Current Liabilities and Note 16 – Commitments and Contingencies . |
Fair Value of Financial Instruments | Fair Value of Financial Instruments —The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. |
Income Taxes | Income Taxes — The provisions for federal, foreign, state and local income taxes are calculated on pre-tax income based on current tax law and include the cumulative effect of any changes in tax rates from those used previously in determining deferred tax assets and liabilities. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. A valuation allowance is recorded to reduce net deferred income tax assets to amounts that are more likely than not to be realized. For uncertain tax positions, the Company determines whether it is “more likely than not” that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit can be recorded in the financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Penalties, if probable and reasonably estimable, are recognized as a component of income tax expense. The Company has reduced its deferred tax assets for uncertain tax positions but has not recorded liabilities for income tax expense, penalties, or interest. |
Contingencies | Contingencies — The Company records a loss contingency for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates. |
Stock-Based Compensation | Stock-Based Compensation — Share-based payments to employees, including grants of restricted stock units (“RSUs”), performance-based non-qualified stock options awards (“PNQs”), restricted stock units with market conditions (“Market RSUs”), options and the compensatory elements of employee stock purchase plans, are recognized in the consolidated statements of operations based upon the fair value of the awards at the grant date. RSUs are valued based on the market price on the grant date. Market RSUs are valued using a Monte Carlo valuation model and RSUs with performance conditions are evaluated for the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options and the compensatory elements of employee stock purchase plans. |
Net Income or (Loss) Per Share of Common Stock | Net Income (Loss) Per Share of Common Stock — Basic net income (loss) per share excludes dilution for potentially dilutive securities and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income or loss per share reflects the potential dilution under the treasury method that could occur if securities or other contracts to issue common stock were exercised or converted into common stock and the if-converted method for convertible debt securities. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted net loss per share as they would be anti-dilutive. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards — In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company is currently evaluating the impact of the guidance on its consolidated financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740) . This ASU requires disaggregated information about a public entity’s effective tax rate reconciliation as well as additional information on income taxes paid. This ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is also permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of the guidance on its consolidated financial statement disclosures. In October 2023, the FASB issued ASU 2023-06, which amends the disclosure and presentation requirements related to various Codification subtopics. The ASU was issued in response to the SEC’s August 2018 final rule that updates and simplifies disclosure requirements the SEC believed were “redundant, duplicative, overlapping, outdated, or superseded.” The new guidance is intended to align U.S. GAAP and SEC requirements while facilitating the application of U.S. GAAP for all entities. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. We are currently evaluating the impact of the guidance on our consolidated financial statements. From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial position or results of operations upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Revenue and Cost of Revenue and Goods Sold Generated From Product Sales, Services and Royalties | The Company’s net revenue and cost of revenue and goods sold as shown on the consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Year Ended December 31, 2023 2022 2021 Net revenue: Product revenue (1) $ 126,054 $ 81,073 $ 39,435 Services (2) 929 3,098 36,007 Royalties (3) 71,979 15,599 — Total net revenue $ 198,962 $ 99,770 $ 75,442 _________________________ (1) Amounts represent the net revenue from Afrezza and V-Go sales to wholesalers and specialty pharmacies and Tyvaso DPI to UT. (2) Amounts represent revenue generated from the Company’s collaboration arrangements, including Next-Gen R&D Services (as defined in Note 11) for UT as well as arrangements with other collaboration partners. See Note 11 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Year Ended December 31, 2023 2022 2021 Cost of goods sold and cost of revenue: Product revenue $ 61,989 $ 55,071 $ 16,833 Services 782 2,426 22,024 Total cost of goods sold and cost of revenue $ 62,771 $ 57,497 $ 38,857 |
Acquisition (Tables)
Acquisition (Tables) - V-Go | 12 Months Ended |
Dec. 31, 2023 | |
Business Acquisition [Line Items] | |
Schedule of Purchase Consideration | The total purchase consideration for V-Go was as follows (in thousands): Fair value of consideration: Amount Cash consideration $ 15,341 Fair value of contingent consideration (1) 610 Total $ 15,951 ___________________________ (1) Subsequent changes in the fair value are reported in general and administrative expenses. See Note 12 – Fair Value of Financial Instruments for subsequent fair value disclosures. |
Schedule of Preliminary Amounts of Identifiable Assets Acquired and Liabilities Assumed | The information below reflects the preliminary amounts of identifiable assets acquired and liabilities assumed as of May 31, 2023 (in thousands): Amount Assets: Inventory (1) $ 11,152 Property and equipment 2,921 Goodwill (1) 1,931 Intangible asset - Developed technology 1,200 Operating lease right-of-use assets 1,812 Total assets 19,016 Liabilities: Liabilities assumed (1) 1,253 Operating lease liability 1,812 Total liabilities 3,065 Net assets acquired $ 15,951 ___________________________ (1) Through May 2023, goodwill related to the acquisition of V-Go was adjusted for a reduction in rebate-related liabilities partially offset by a reserve for inventory obsolescence. |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of Investments [Abstract] | |
Schedule of Contractual Maturities of Held to Maturity Investments | The contractual maturities of the Company’s held-to-maturity investments are summarized below (in thousands): December 31, 2023 December 31, 2022 Amortized Aggregate Amortized Aggregate Due in one year or less (1) $ 115,263 $ 115,374 $ 152,862 $ 156,976 Due after one year through five years 7,155 7,197 1,961 1,948 Total $ 122,418 $ 122,571 $ 154,823 $ 158,924 ___________________________ The investments due in one year or less include cash equivalents of $ 58.6 million as of December 31, 2023 and $ 51.8 million as of December 31, 2022 . |
Schedule of Fair Value of Cash Equivalents, Long and Short Term Investments | The fair value of the cash equivalents, long-term and short-term investments are disclosed below (in millions): December 31, 2023 Investment Level Amortized Cost Gross Unrealized Estimated Commercial bonds and paper Level 2 $ 43.3 $ 0.1 $ 43.4 Money market funds Level 1 69.6 — 69.6 U.S. Treasuries Level 2 9.5 0.1 9.6 Total cash equivalents and investments 122.4 0.2 122.6 Less: cash equivalents ( 58.6 ) — ( 58.6 ) Total Investments $ 63.8 $ 0.2 $ 64.0 December 31, 2022 Investment Level Amortized Cost Gross Unrealized Estimated Commercial bonds and paper Level 2 $ 66.8 $ ( 0.6 ) $ 66.2 Money market funds Level 1 51.8 — 51.8 U.S. Treasuries Level 2 36.3 ( 0.6 ) 35.7 Total cash equivalents and investments 154.9 ( 1.2 ) 153.7 Less: cash equivalents ( 51.8 ) — ( 51.8 ) Total Investments $ 103.1 $ ( 1.2 ) $ 101.9 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consists of the following (in thousands): December 31, 2023 December 31, 2022 Accounts receivable – commercial Accounts receivable, gross $ 20,199 $ 19,359 Wholesaler distribution fees and prompt pay discounts ( 2,469 ) ( 2,536 ) Reserve for returns ( 6,215 ) ( 4,108 ) Allowance for credit losses ( 157 ) — Total accounts receivable – commercial, net 11,358 12,715 Accounts receivable – collaborations and services 3,543 4,086 Total accounts receivable, net $ 14,901 $ 16,801 |
Schedule of Activities and Ending Reserve Balance | The Company recognizes revenue net of gross-to-net adjustments. The activities and ending reserve balance consists of the following (in thousands): December 31, 2023 December 31, 2022 Prompt Pay Discount Reserve, Allowance for Wholesale Distribution Fees Beginning balance $ 6,644 $ 4,493 Provisions 18,977 17,471 Deductions ( 16,780 ) ( 15,320 ) Ending balance $ 8,841 $ 6,644 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventories consist of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 6,262 $ 5,739 Work-in-process 13,646 13,815 Finished goods 8,637 2,218 Total inventory $ 28,545 $ 21,772 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) December 31, 2023 December 31, 2022 Land — $ 875 $ 875 Buildings 39 - 40 17,389 17,389 Building improvements 5 - 40 46,357 38,952 Machinery and equipment 3 - 15 60,410 58,542 Furniture, fixtures and office equipment 5 - 10 3,070 2,976 Computer equipment and software 3 8,658 8,246 Construction in progress — 48,997 16,706 Total property and equipment 185,756 143,686 Less accumulated depreciation ( 101,536 ) ( 98,560 ) Total property and equipment, net $ 84,220 $ 45,126 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Asset (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Other Intangible Asset | Other Intangible Asset — Other intangible asset consisted of the following (in thousands): Estimated December 31, 2023 December 31, 2022 Useful Cost Accumulated Net Book Value Cost Accumulated Net Book Value Developed technology 15 $ 1,200 $ ( 127 ) $ 1,073 $ 1,200 $ ( 47 ) $ 1,153 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities were comprised of the following (in thousands): December 31, 2023 December 31, 2022 Salary and related expenses $ 19,506 $ 14,906 Discounts and allowances for commercial product sales 9,541 8,504 Accrued interest 2,153 2,201 State income tax liability 1,561 — Deferred lease liability 1,423 1,304 Professional fees 979 1,136 Current portion of milestone rights liability 752 924 Returns reserve for acquired product 601 1,013 Danbury facility buildout 316 846 Other 5,204 4,719 Accrued expenses and other current liabilities $ 42,036 $ 35,553 |
Schedule of Provision for Discounts and Allowances for Commercial Product Sales | The provision for discounts and allowances for commercial product sales is reflected as a component of net revenues. The activities and ending balances consisted of the following (in thousands): December 31, 2023 December 31, 2022 Discounts and allowances for commercial product sales: Beginning balance $ 8,504 $ 4,227 Provisions 34,980 23,369 Deductions ( 33,943 ) ( 20,603 ) V-Go opening balance sheet — 1,511 Ending balance $ 9,541 $ 8,504 |
Borrowings (Tables)
Borrowings (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Carrying Amount of Borrowings | Carrying amount of the Company’s borrowings consisted of the following (in thousands): December 31, 2023 December 31, 2022 Senior convertible notes $ 226,851 $ 225,397 MidCap credit facility 33,019 39,264 Mann Group convertible note 8,829 8,829 Total debt – net carrying amount $ 268,699 $ 273,490 |
Schedule of Line of Credit Facility Debt and Key Terms | The following table provides a summary of the Company’s principal balance of debt and key terms: Amount Due Terms December 31, 2023 December 31, 2022 Annual Interest Maturity Date Conversion Price Senior convertible notes $ 230.0 million $ 230.0 million 2.50 % March 2026 $ 5.21 MidCap credit facility $ 33.3 million $ 40.0 million one-month 1 % floor) 6.25 %; 8.25 % (1 ) August 2025 N/A Mann Group convertible note $ 8.8 million $ 8.8 million 2.50 % December 2025 $ 2.50 _________________________ (1) In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). |
Schedule of Maturities of the Company's Borrowings | The maturities of the Company’s borrowings as of December 31, 2023 are as follows (in thousands): Amounts 2024 $ 20,000 2025 22,163 2026 230,000 Total principal payments 272,163 Unamortized discount and prepayment fee ( 313 ) Debt issuance costs ( 3,151 ) Total debt $ 268,699 |
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs | Amortization of the premium and accretion of debt issuance costs related to all borrowings for the years ended December 31, 2023, 2022 and 2021 are as follows (in thousands): Year Ended December 31, 2023 2022 2021 Amortization of debt discount and prepayment fee $ 423 $ 431 $ 377 Amortization of debt issuance cost 1,454 1,453 1,215 |
Collaboration, Licensing and _2
Collaboration, Licensing and Other Arrangements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of Total Revenue from Collaboration and Services | Revenue from collaborations and services were as follows (in thousands): Year Ended December 31, 2023 2022 2021 UT CSA Agreement (1) $ 52,025 $ 24,826 $ 267 UT License Agreement (2) 782 2,426 34,145 Cipla License and Distribution Agreement 147 147 147 Vertice Pharma Co-Promotion Agreement — 325 1,147 Other — 200 323 Receptor CLA — — 245 Total revenue from collaborations and services $ 52,954 $ 27,924 $ 36,274 _________________________ (1) Amounts consist of revenue recognized for Manufacturing Services and sales of product to UT for the periods presented. (2) Amounts consist of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented. |
Schedule of Deferred Revenue Related to Revenue Recognized for Collaborations and Services | The activity related to deferred revenue and the related revenue recognized for collaborations and services is as follows (in thousands): December 31, 2023 December 31, 2022 Deferred revenue: Beginning balance $ 39,417 $ 20,370 Additions 92,416 46,971 Revenue — collaborations and services ( 52,954 ) ( 27,924 ) Ending balance $ 78,879 $ 39,417 |
Schedule of Effect of Modification on Transaction Price | The Company determined that the capital and continuous improvements should be combined with the manufacturing services performance obligation and the alternative manufacturing processes should be combined with the Next-Gen R&D Services. The total revised anticipated cash flows of $ 722.3 million from the transaction was allocated to the three distinct performance obligations as follows (dollars in millions). Anticipated Cash Flow Revenue Allocation Recognition Method Progress Measure Revenue Total anticipated cash flow (1) $ 722.3 Distinct Performance Obligation R&D Services and License $ — Over time Ratably Aug 2021 - Oct 2021 Next-Gen R&D Services $ 10.0 Over time Input % of completion of costs Manufacturing Services and (2) $ 712.3 Point in time Transfer of control __________________________ (1) The total anticipated cash flow includes a transaction price of $ 120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA. (2) The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $ 220.8 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received. |
United Therapeutics Corporation | |
Schedule of Total Revenue from Collaboration and Services | Total revenue from UT was as follows (in thousands): Year Ended December 31, 2023 2022 2021 UT Revenue UT CSA Agreement $ 52,025 $ 24,826 $ 267 UT License Agreement 782 2,426 34,145 Royalties — Collaborations (1) 71,979 15,599 — Total revenue from UT $ 124,786 $ 42,851 $ 34,412 _________________________ Amounts consist of royalties associated with the UT License Agreement. The contract assets related to the royalties is included in prepaid expense and other current assets in the consolidated balance sheets |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | The following tables set forth the fair value of the Company’s financial instruments (Level 3 in the fair value hierarchy) (in millions): December 31, 2023 Fair Value Carrying Amount Significant Financial liabilities: Senior convertible notes (1) $ 226.9 $ 231.3 MidCap credit facility (2) 33.0 35.5 Mann Group convertible note (3) 8.8 14.4 Milestone rights (4) 3.9 11.9 Contingent milestone liability (5) 0.3 0.3 Financing liability (6) 104.1 106.8 _________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 11 %, volatility of 62.7 % and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 224.1 million and $ 238.9 million, respectively. (2) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 12 %. A change in yield of + or – 2 % would result in a fair value of $ 35.0 million and $ 36.0 million, respectively. (3) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 13 % and volatility of 62.7 % to the straight note and a binomial option pricing model for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 14.2 million and $ 14.7 million, respectively. (4) Fair value was determined by applying a Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 3.88 %, dividend yield of 0 %, volatility of 50 %, period of 8 years and credit risk of 17 % . (5) Fair value was determined by using the Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 4.01 %, dividend yield of 0 %, volatility of 43 %, period of 15 years and credit risk of 17 % . (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. December 31, 2022 Fair Value Carrying Value Significant Financial liabilities: Senior convertible notes (1) $ 225.4 $ 253.9 MidCap credit facility (2) 39.3 41.1 Mann Group convertible note (3) 8.8 20.8 Milestone rights (4) 4.8 12.6 Contingent milestone liability (5) 0.6 1.0 Financing liability (6) 104.1 103.2 __________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 13 %, volatility of 75.8 % and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 245.0 million and $ 263.4 million, respectively. (2) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 12 %. A change in yield of + or – 2 % would result in a fair value of $ 40.0 million and $ 42.4 million, respectively. (3) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 13 % and volatility of 77.8 % to the straight note and a binomial option pricing model for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 20.5 million and $ 21.2 million, respectively. (4) Fair value was determined by applying a Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 3.99 %, dividend yield of 0 %, volatility of 50 %, period of 8 years and credit risk of 17 % . (5) Fair value was determined by using the Monte Carlo simulation method for the calculation of th e potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market-based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 4.01 %, dividend yield of 0 %, volatility of 43 %, period of 15 years and credit risk of 17 % . (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 10 %. |
Earnings Per Common Share ("E_2
Earnings Per Common Share ("EPS") (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Components of Basic and Diluted EPS Computations | The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts): Year Ended December 31, 2023 2022 2021 EPS — basic and diluted: Net loss (numerator) $ ( 11,938 ) $ ( 87,400 ) $ ( 80,926 ) Weighted average common shares (denominator) 267,014 257,092 249,244 Net loss per share $ ( 0.04 ) $ ( 0.34 ) $ ( 0.32 ) |
Potential Dilutive Securities Outstanding that are Considered Antidilutive | Potentially dilutive securities outstanding which were considered antidilutive are summarized as follows (in shares): Year Ended December 31, 2023 2022 2021 Senior convertible notes 44,120,463 44,120,463 44,120,463 RSUs and Market RSUs (1) 7,855,144 18,886,710 7,609,025 Common stock options and PNQs 8,400,611 9,074,587 10,655,146 Mann Group convertible notes 3,370,000 3,370,000 7,370,000 Employee stock purchase plan — — 243,375 Total shares 63,746,218 75,451,760 69,998,009 _________________________ (1) Market RSUs issued in 2021, 2022, and 2023 are included at the share delivery of 0 %, 140 %, and 0 %, respectively, in accordance with a valuation assessment obtained as of December 31, 2023. |
Stock Award Plans (Tables)
Stock Award Plans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Based Award Plans | The following table summarizes information about the Company’s stock-based award plans as of December 31, 2023: Outstanding Outstanding Shares Available 2013 Equity Incentive Plan 2,966,524 — — 2018 Equity Incentive Plan 5,434,087 12,363,934 26,374,063 Total 8,400,611 12,363,934 26,374,063 |
Stock Based Compensation Expense Recognized in Consolidated Statements of Operations by Category | Total stock-based compensation expense recognized in the consolidated statements of operations is included in the following categories (in thousands): Year Ended December 31, 2023 2022 2021 Cost of goods sold $ 1,589 $ 329 $ 407 Cost of revenue — collaborations and services 897 1,425 1,708 Research and development 1,442 1,044 614 Selling 2,291 1,194 2,578 General and administrative 11,430 9,455 6,893 Total $ 17,649 $ 13,447 $ 12,200 |
Summary of Stock Options Outstanding | The following table summarizes information relating to stock options: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2023 9,074,587 $ 3.06 5.10 $ 29,512 Granted — — Exercised ( 445,376 ) 1.57 Forfeited ( 3,420 ) 2.53 Expired ( 225,180 ) 30.97 Outstanding as of December 31, 2023 8,400,611 $ 2.39 4.07 $ 15,153 Exercisable as of December 31, 2023 7,938,892 $ 2.40 4.12 $ 14,450 |
Summary of Restricted Stock Unit Activity | The following table summarizes information relating to restricted stock units: Number of Weighted Outstanding as of January 1, 2023 11,838,329 $ 3.65 Granted 7,531,650 5.17 Vested ( 6,053,264 ) 3.41 Forfeited ( 952,781 ) 4.80 Outstanding as of December 31, 2023 12,363,934 4.61 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Term and Discount Rate | Financing liability information was as follows (dollars in thousands): December 31, 2023 December 31, 2022 Weighted average remaining lease term (in years) 17.8 18.8 Weighted average discount rate 9.0 % 9.0 % Lease information was as follows (dollars in thousands): December 31, 2023 December 31, 2022 Operating lease right-of-use assets (1) $ 4,685 $ 6,714 Operating lease liability-current (2) $ 1,423 $ 1,304 Operating lease liability-long-term 3,925 5,343 Total $ 5,348 $ 6,647 Weighted average remaining lease term (in years) 3.7 4.6 Weighted average discount rate 7.3 % 7.3 % __________________________ (1) Operating right-of-use assets related to vehicles, offices and the manufacturing facility are included in other assets in the consolidated balance sheets. (2) Operating lease liability – current are included in accrued expenses and other current liabilities in the consolidated balance sheets. |
Summary of Lease Information | Year Ended December 31, 2023 2022 2021 Interest expense on financing liability $ 9,825 $ 9,758 $ 1,373 Year Ended December 31, 2023 2022 2021 Operating lease costs $ 1,675 $ 1,525 $ 863 Variable lease costs 104 274 515 Cash paid 1,068 1,823 1,867 |
Summary of Financing Liability Payments | The Company's remaining financing liability payments were as follows (in thousands): December 31, 2023 2024 $ 10,018 2025 10,269 2026 10,533 2027 10,849 2028 11,174 Thereafter 177,278 Total 230,121 Interest payments ( 123,318 ) Debt issuance costs ( 2,675 ) Total financing liability $ 104,128 |
Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements | The Company's remaining purchase commitments and estimated capacity fee liability as of December 31, 2023, as well as pre-amendment purchase commitments as of September 30, 2023, were as follows (€ in millions): December 31, 2023 September 30, 2023 Remaining Purchase Commitments Estimated Capacity Fees Remaining Purchase Commitments 2023 — — 2.4 2024 2.9 — 14.6 2025 — 1.5 15.5 2026 (1) 4.2 2.0 19.4 2027 6.0 1.0 9.2 2028 6.0 1.0 — 2029 6.0 1.0 — 2030 6.0 1.0 — 2031 8.0 0.5 — 2032 8.0 0.5 — 2033 8.0 0.5 — 2034 4.4 0.5 — Total 59.5 9.5 61.1 __________________________ (1) If there is a delay in the availability of insulin with FDA approved inclusion bodies and supply does not begin in 2026 as currently expected, the Company will incur a capacity fee of € 750,000 per quarter that the product is not available for purchase. |
Schedule of Future Minimum Office And Vehicle Lease Payments | The Company's future minimum office and vehicle lease payments were as follows (in thousands): December 31, 2023 2024 $ 1,496 2025 1,861 2026 1,140 2027 1,072 2028 643 Total 6,212 Interest expense ( 864 ) Total operating lease liability $ 5,348 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Loss from Continuing Operations Before Provision for Income Taxes | Loss from continuing operations before provision for income taxes for the Company’s domestic and international operations was as follows (in thousands): Year Ended December 31, 2023 2022 2021 United States $ ( 10,377 ) $ ( 87,400 ) $ ( 80,926 ) Foreign — — — Loss before provision for income taxes $ ( 10,377 ) $ ( 87,400 ) $ ( 80,926 ) |
Provision for Income Taxes | The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2023 2022 2021 Current U.S. federal $ — $ — $ — U.S. state 1,555 — — Non-U.S. — — — Total current 1,555 — — Deferred U.S. federal ( 190 ) ( 5,606 ) ( 5,170 ) U.S. state 7,002 ( 4,334 ) ( 14,461 ) Non-U.S. — — — Total deferred 6,812 ( 9,940 ) ( 19,631 ) Valuation allowance (6,806 ) 9,940 19,631 Net deferred 6 — — Total $ 1,561 $ — $ — |
Components of Net Deferred Tax Assets | Components of the net deferred tax assets are approximately as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 506,641 $ 542,537 Research and development credits 77,007 78,804 Capitalized research costs 14,225 4,369 Milestone Rights 1,006 1,331 Accrued expenses 3,760 2,675 Loss on purchase commitment 22,806 23,117 Non-qualified stock option expense 3,559 7,686 Capitalized patent costs 6,720 8,058 Other 3,405 3,204 Lease liability 1,280 1,624 Interest expense limitation 2,782 10,991 Depreciation 21,134 22,157 Deferred product revenue and costs 346 370 Sale of future royalties 34,848 - Total deferred tax assets 699,519 706,923 Valuation allowance ( 698,228 ) ( 705,034 ) Net deferred tax assets $ 1,291 $ 1,889 Deferred tax liabilities: Right of use asset $ ( 1,121 ) $ ( 1,640 ) Other prepaids ( 176 ) ( 249 ) Total deferred tax liabilities ( 1,297 ) ( 1,889 ) Net deferred tax assets $ ( 6 ) $ — |
Effective Tax Rate | The Company’s effective tax rate differs from the statutory federal income tax rate as follows: Year Ended December 31, 2023 2022 2021 Federal tax benefit rate 21.0 % 21.0 % 21.0 % State tax expense (net of federal benefit) - 11.8 % 0.0 % 0.0 % Permanent items - 2.8 % - 0.1 % - 4.4 % Officers compensation - 35.3 % - 1.1 % 0.0 % Stock based compensation - 5.6 % 0.4 % 0.3 % Tax attribute expirations 0.4 % - 13.2 % - 5.9 % Valuation allowance 9.1 % - 7.2 % - 11.2 % Other deferred adjustments 10.0 % 0.2 % 0.2 % Effective income tax rate - 15.0 % 0.0 % 0.0 % |
Summary of Positions for which Significant Change in Unrecognized Tax Benefits | A reconciliation of beginning and ending amounts of unrecognized tax benefits was as follows (in thousands): Year Ended December 31, 2023 2022 2021 Unrecognized Tax Benefit Beginning of Year $ 268,902 $ 268,902 $ 268,902 Gross increases for tax positions of prior years — — — Gross decreases for tax positions of current year — — — Settlements — — — Lapse of statute of limitations — — — End of Year $ 268,902 $ 268,902 $ 268,902 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 Segment | Aug. 31, 2019 USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||
Number of operating segment | Segment | 1 | |
MidCap Credit Facility | ||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||
Minimum cash covenant | $ | $ 90 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) € in Millions | 1 Months Ended | 12 Months Ended | ||||||||
Jan. 01, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 EUR (€) | Sep. 30, 2023 EUR (€) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jul. 01, 2013 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Accretion or amortization | $ 1,600,000 | $ 700,000 | ||||||||
Allowance for credit losses | $ 0 | 0 | ||||||||
Purchase of available-for-sale securities | 5,000,000 | $ 3,000,000 | ||||||||
Percentage of future royalties | 1% | |||||||||
Loss on purchase commitments | € | € 59.5 | € 61.1 | ||||||||
MidCap Credit Facility | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Principal amount | $ 33,300,000 | 40,000,000 | ||||||||
Milestone Rights Liability | Deerfield | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Contingent liability remain payable | 900,000 | 1,100,000 | $ 55,000,000 | |||||||
Contingent liability for milestone payments | $ 5,000,000 | $ 5,000,000 | ||||||||
Convertible Promissory Note | Thirona Bio, Inc. | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Purchase of available-for-sale securities | $ 5,000,000 | $ 3,000,000 | ||||||||
Interest rate | 6% | |||||||||
Investment securities | 6,900,000 | 7,100,000 | ||||||||
Available-for-Sale Investment, credit losses | 200,000 | 900,000 | ||||||||
Principal amount | 8,000,000 | |||||||||
Insulin | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Loss on purchase commitments | $ 64,800,000 | $ 72,300,000 | ||||||||
Tyvaso DPI | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Percentage of royalty on net sales | 10% | |||||||||
Percentage of royalty on net revenue | 10% | |||||||||
Percentage of future royalties | 9% | |||||||||
Minimum | AFREZZA product sales | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Sales return right following product expiration in months | 6 months | |||||||||
Maximum | Milestone Rights Liability | Deerfield | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Contingent liability for milestone payments | $ 90,000,000 | |||||||||
Maximum | AFREZZA product sales | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Sales return right following product expiration in months | 12 months |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail 1) | Dec. 31, 2023 |
Collaborations and services | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2024-01-01 | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining performance obligation, Expected timing of satisfaction, period | 12 months |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Revenue and Cost of Revenue and Goods Sold Generated From Product Sales, Services and Royalties (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 198,962 | $ 99,770 | $ 75,442 |
Operating Expenses | 62,771 | 57,497 | 38,857 |
Product Revenue | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 126,054 | 81,073 | 39,435 |
Operating Expenses | 61,989 | 55,071 | 16,833 |
Services | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 929 | 3,098 | 36,007 |
Operating Expenses | 782 | 2,426 | $ 22,024 |
Royalties | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 71,979 | $ 15,599 |
Acquisition - Additional Inform
Acquisition - Additional Information (Detail) | 12 Months Ended | ||||
May 31, 2022 USD ($) yr | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | May 31, 2023 USD ($) | [1] | |
Business Acquisition [Line Items] | |||||
Incremental borrowing rate | 7.25% | 7.30% | 7.30% | ||
V-Go | |||||
Business Acquisition [Line Items] | |||||
Inventory | $ 11,200,000 | $ 11,152,000 | |||
Acquisition-related costs | $ 0 | $ 400,000 | |||
V-Go | Risk-Free Rate | |||||
Business Acquisition [Line Items] | |||||
Measurement inputs | 0.0295 | ||||
V-Go | Dividend Yield | |||||
Business Acquisition [Line Items] | |||||
Measurement inputs | 0 | ||||
V-Go | Volatility | |||||
Business Acquisition [Line Items] | |||||
Measurement inputs | 0.65 | ||||
V-Go | Period | |||||
Business Acquisition [Line Items] | |||||
Measurement inputs | yr | 15 | ||||
V-Go | Credit Risk | |||||
Business Acquisition [Line Items] | |||||
Measurement inputs | 0.12 | ||||
V-Go | |||||
Business Acquisition [Line Items] | |||||
Asset acquisition, date of acquisition agreement | May 31, 2022 | ||||
Asset acquisition, up-front consideration | $ 15,341,000 | ||||
Goodwill amortization period | 15 years | ||||
V-Go | Maximum | |||||
Business Acquisition [Line Items] | |||||
Sales-based milestone payments payable | $ 10,000,000 | ||||
Annual revenue milestones ranges for milestone payments | 100,000,000 | ||||
V-Go | Minimum | |||||
Business Acquisition [Line Items] | |||||
Annual revenue milestones ranges for milestone payments | $ 40,000,000 | ||||
[1] Through May 2023, goodwill related to the acquisition of V-Go was adjusted for a reduction in rebate-related liabilities partially offset by a reserve for inventory obsolescence. |
Acquisition - Schedule of Purch
Acquisition - Schedule of Purchase Consideration (Detail) - V-Go $ in Thousands | May 31, 2022 USD ($) | |
Fair value of consideration: | ||
Cash consideration | $ 15,341 | |
Fair value of contingent consideration | 610 | [1] |
Total | $ 15,951 | |
[1] Subsequent changes in the fair value are reported in general and administrative expenses. See Note 12 – Fair Value of Financial Instruments for subsequent fair value disclosures. |
Acquisition - Schedule of Preli
Acquisition - Schedule of Preliminary Amounts of Identifiable Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | May 31, 2023 | Dec. 31, 2022 | May 31, 2022 | ||
Assets: | ||||||
Goodwill | $ 1,931 | $ 2,428 | ||||
V-Go | ||||||
Assets: | ||||||
Inventory | $ 11,152 | [1] | $ 11,200 | |||
Property and equipment | 2,921 | |||||
Goodwill | [1] | 1,931 | ||||
Intangible asset - Developed technology | 1,200 | |||||
Operating lease right-of-use assets | 1,812 | |||||
Total assets | 19,016 | |||||
Liabilities: | ||||||
Liabilities assumed | [1] | 1,253 | ||||
Operating lease liability | 1,812 | |||||
Total liabilities | 3,065 | |||||
Net assets acquired | $ 15,951 | |||||
[1] Through May 2023, goodwill related to the acquisition of V-Go was adjusted for a reduction in rebate-related liabilities partially offset by a reserve for inventory obsolescence. |
Investments - Additional Inform
Investments - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) Note | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Schedule Of Investments [Line Items] | |||
Interest on available for sale investment | $ 500,000 | $ 500,000 | |
Accretion or amortization | 1,600,000 | 700,000 | |
Allowance for credit losses | $ 0 | 0 | |
Accrued interest receivable | 600,000 | ||
Amount receivable on matured investment | 5,100,000 | ||
Convertible Promissory Note | Thirona Bio, Inc. | |||
Schedule Of Investments [Line Items] | |||
Number of notes | Note | 2 | ||
Amount Due | $ 8,000,000 | ||
Stated interest rate | 6% | ||
Investment securities | $ 6,900,000 | 7,100,000 | |
Available-for-Sale Investment, credit losses | 200,000 | 900,000 | |
Unrealized holding gain or loss | 0 | $ 0 | $ 0 |
Prepaid Expenses and Other Current Assets | |||
Schedule Of Investments [Line Items] | |||
Accrued interest receivable | $ 500,000 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Held to Maturity Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Securities, Held-to-Maturity, Maturity [Abstract] | |||
Amortized cost basis, due in one year or less | [1] | $ 115,263 | $ 152,862 |
Amortized cost basis due after one year through five years | 7,155 | 1,961 | |
Amortized cost basis, total | 122,418 | 154,823 | |
Aggregate fair value, due in one year or less | [1] | 115,374 | 156,976 |
Aggregate fair value, due after one year through five years | 7,197 | 1,948 | |
Aggregate fair value, total | $ 122,571 | $ 158,924 | |
[1] The investments due in one year or less include cash equivalents of $ 58.6 million as of December 31, 2023 and $ 51.8 million as of December 31, 2022 . |
Investments - Schedule of Con_2
Investments - Schedule of Contractual Maturities of Held to Maturity Investments (Parenthetical) (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule Of Held To Maturity Securities [Line Items] | ||
Cash and cash equivalents | $ 238,480 | $ 69,767 |
Due in One Year or Less | ||
Schedule Of Held To Maturity Securities [Line Items] | ||
Cash and cash equivalents | $ 58,600 | $ 51,800 |
Investments - Schedule of Fair
Investments - Schedule of Fair Value of Cash Equivalents, Long and Short Term Investments (Detail) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Amortized Cost | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | $ 122.4 | $ 154.9 |
Less: cash equivalents | (58.6) | (51.8) |
Total Investments | 63.8 | 103.1 |
Amortized Cost | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 43.3 | 66.8 |
Amortized Cost | Money Market Funds | Fair Value, Inputs, Level 1 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 69.6 | 51.8 |
Amortized Cost | U.S. Treasuries | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 9.5 | 36.3 |
Gross Unrealized Holding Gains (Losses) | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 0.2 | (1.2) |
Total Investments | 0.2 | (1.2) |
Gross Unrealized Holding Gains (Losses) | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 0.1 | (0.6) |
Gross Unrealized Holding Gains (Losses) | U.S. Treasuries | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 0.1 | (0.6) |
Estimated Fair Value | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 122.6 | 153.7 |
Less: cash equivalents | (58.6) | (51.8) |
Total Investments | 64 | 101.9 |
Estimated Fair Value | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 43.4 | 66.2 |
Estimated Fair Value | Money Market Funds | Fair Value, Inputs, Level 1 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | 69.6 | 51.8 |
Estimated Fair Value | U.S. Treasuries | Fair Value, Inputs, Level 2 | ||
Schedule of Investments [Line Items] | ||
Total cash equivalents and investments | $ 9.6 | $ 35.7 |
Schedule of Accounts Receivable
Schedule of Accounts Receivable, Net (Detail) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts Receivable [Line Items] | ||
Total accounts receivable, net | $ 14,901,000 | $ 16,801,000 |
Allowance for credit losses | 0 | |
Commercial product sales | ||
Accounts Receivable [Line Items] | ||
Accounts receivable, gross | 20,199,000 | 19,359,000 |
Wholesaler distribution fees and prompt pay discounts | (2,469,000) | (2,536,000) |
Reserve for returns | (6,215,000) | (4,108,000) |
Total accounts receivable, net | 11,358,000 | 12,715,000 |
Allowance for credit losses | (157,000) | |
Collaborations and services | ||
Accounts Receivable [Line Items] | ||
Total accounts receivable, net | $ 3,543,000 | $ 4,086,000 |
Accounts Receivable - Additiona
Accounts Receivable - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2023 USD ($) Distributor | Dec. 31, 2022 USD ($) Distributor | |
Accounts Receivable [Line Items] | ||
Number of wholesale distributors | Distributor | 3 | 3 |
Percentage of gross sales from major wholesale distributors | 85% | 74% |
Allowance for credit losses and doubtful accounts | $ 0 | |
Percentage of revenue from major customers collaborations and services | 100% | 98% |
United Therapeutics Corporation | ||
Accounts Receivable [Line Items] | ||
Percentage of collaborations and services net accounts receivables | 100% | |
Zealand | ||
Accounts Receivable [Line Items] | ||
Allowance for credit losses and doubtful accounts | $ 200,000 | |
Accounts receivable | $ 200,000 | |
Commercial product sales | ||
Accounts Receivable [Line Items] | ||
Percentage of accounts receivable from major wholesale distributors | 74% | 79% |
Allowance for credit losses and doubtful accounts | $ 157,000 | |
Accounts receivable | $ 20,199,000 | $ 19,359,000 |
Schedule of Activities and Endi
Schedule of Activities and Ending Reserve Balance (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reserve Balance [Abstract] | ||
Beginning balance | $ 6,644 | $ 4,493 |
Provisions | 18,977 | 17,471 |
Deductions | (16,780) | (15,320) |
Ending balance | $ 8,841 | $ 6,644 |
Inventories - Components of Inv
Inventories - Components of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 6,262 | $ 5,739 |
Work-in-process | 13,646 | 13,815 |
Finished goods | 8,637 | 2,218 |
Total inventory | $ 28,545 | $ 21,772 |
Inventories - Additional Inform
Inventories - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory [Line Items] | |||
Inventory write-offs | $ 4,574 | $ 2,202 | $ 1,902 |
Pre-launch Inventory | |||
Inventory [Line Items] | |||
Raw materials inventory | $ 800 | $ 800 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 185,756 | $ 143,686 |
Less accumulated depreciation | (101,536) | (98,560) |
Total property and equipment, net | 84,220 | 45,126 |
Land | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 875 | 875 |
Buildings | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 17,389 | 17,389 |
Buildings | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 39 years | |
Buildings | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 40 years | |
Building Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 46,357 | 38,952 |
Building Improvements | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Building Improvements | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 40 years | |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 60,410 | 58,542 |
Machinery and Equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Machinery and Equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 15 years | |
Furniture, fixtures and office equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 3,070 | 2,976 |
Furniture, fixtures and office equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Furniture, fixtures and office equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Life (Years) | 10 years | |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 8,658 | 8,246 |
Estimated Useful Life (Years) | 3 years | |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 48,997 | $ 16,706 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |||
Nov. 08, 2021 | Nov. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | |||||
Depreciation Expense | $ 4.5 | $ 3.3 | $ 2 | ||
Net book value of disposed assets | 0.6 | ||||
Casper L L C | |||||
Property Plant And Equipment [Line Items] | |||||
Sale price | $ 102.3 | $ 102.3 | |||
Sale leaseback transaction, lease agreement period. | 20 years | ||||
Sale leaseback transaction, date | November 2021 | ||||
Manufacturing Equipment, Computer Hardware and Software, Computer Equipment, Lab Equipment, and Building Improvements | |||||
Property Plant And Equipment [Line Items] | |||||
Amount of divestiture of long-lived | $ 2.1 | $ 2.4 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Asset - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Goodwill | $ 1,931 | $ 2,428 |
2024 | 100 | |
2025 | 100 | |
2026 | 100 | |
2027 | 100 | |
2028 | 100 | |
After 2028 | 700 | |
Other Intangible Asset | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization expense | $ 100 | $ 100 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Asset - Summary of Other Intangible Asset (Detail) - Developed Technology - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite Lived Intangible Assets [Line Items] | ||
Estimated Useful Life (Years) | 15 years | |
Cost | $ 1,200 | $ 1,200 |
Accumulated Amortization | (127) | (47) |
Net Book Value | $ 1,073 | $ 1,153 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Salary and related expenses | $ 19,506 | $ 14,906 |
Discounts and allowances for commercial product sales | 9,541 | 8,504 |
Accrued interest | 2,153 | 2,201 |
State income tax liability | 1,561 | |
Deferred lease liability | 1,423 | 1,304 |
Professional fees | 979 | 1,136 |
Current portion of milestone rights liability | 752 | 924 |
Returns reserve for acquired product | 601 | 1,013 |
Danbury facility buildout | 316 | 846 |
Other | 5,204 | 4,719 |
Accrued expenses and other current liabilities | $ 42,036 | $ 35,553 |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Schedule of Provision for Discounts and Allowances for Commercial Product Sales (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Discounts and allowances for commercial product sales: | ||
Beginning balance | $ 8,504 | $ 4,227 |
Provisions | 34,980 | 23,369 |
Deductions | (33,943) | (20,603) |
V-Go opening balance sheet | 1,511 | |
Ending balance | $ 9,541 | $ 8,504 |
Borrowings - Summary of Carryin
Borrowings - Summary of Carrying Amount of Borrowings (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Senior convertible notes | $ 226,851 | $ 225,397 |
Mann Group convertible note | 226,851 | 225,397 |
Total debt — net carrying amount | 268,699 | 273,490 |
Related Party | ||
Debt Instrument [Line Items] | ||
Mann Group convertible note | 8,829 | 8,829 |
MidCap Credit Facility | ||
Debt Instrument [Line Items] | ||
Credit Facility | $ 33,019 | $ 39,264 |
Borrowings - Schedule of Line o
Borrowings - Schedule of Line of Credit Facility Debt and Key Terms (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Aug. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 04, 2021 | ||
Senior Convertible Notes | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 230 | $ 230 | ||||
Annual interest rate | 2.50% | 2.50% | ||||
Maturity date | 2026-03 | |||||
Conversion price | $ 5.21 | $ 5.21 | ||||
MidCap Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 33.3 | $ 40 | ||||
Maturity date | 2025-08 | |||||
MidCap Credit Facility | SOFR | ||||||
Debt Instrument [Line Items] | ||||||
Annual interest rate | 6.25% | 6.25% | [1] | |||
Interest rate floor | 1% | 1% | [1] | 1% | ||
Interest rate cap | 8.25% | 8.25% | [1] | 8.25% | ||
The Mann Group L L C | Convertible Promissory Note | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 8.8 | $ 8.8 | ||||
Accrued interest paid-in-kind | $ 0.4 | |||||
Annual interest rate | 2.50% | [1] | 2.50% | |||
Maturity date | 2025-12 | |||||
Conversion price | $ 2.5 | |||||
[1] In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). |
Borrowings - Schedule of Line_2
Borrowings - Schedule of Line of Credit Facility Debt and Key Terms (Parenthetical) (Detail) - MidCap Credit Facility | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Debt Instrument [Line Items] | ||||
Maturity date | 2025-08 | |||
SOFR | ||||
Debt Instrument [Line Items] | ||||
Annual interest rate | 6.25% | 6.25% | [1] | |
Interest rate floor | 1% | 1% | [1] | 1% |
Interest rate cap | 8.25% | 8.25% | [1] | 8.25% |
[1] In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). |
Borrowings - Schedule of Maturi
Borrowings - Schedule of Maturities of the Company's Borrowings (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
2024 | $ 20,000 | |
2025 | 22,163 | |
2026 | 230,000 | |
Total principal payments | 272,163 | |
Unamortized discount | (313) | |
Debt issuance costs | (3,151) | |
Total debt — net carrying amount | $ 268,699 | $ 273,490 |
Borrowings - Senior Convertible
Borrowings - Senior Convertible Notes - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||||
Apr. 22, 2021 | Mar. 04, 2021 USD ($) d $ / shares | Aug. 31, 2019 | Dec. 31, 2023 USD ($) d $ / shares | Dec. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) $ / shares | Mar. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||||
Maturity date | Dec. 31, 2025 | Nov. 03, 2024 | |||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||
Proceeds from offering after deducting initial purchasers discounts and commissions and estimated offering expenses payable | $ 230,000,000 | ||||||
Senior Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 230,000,000 | $ 230,000,000 | |||||
Maturity date | Mar. 01, 2026 | ||||||
Annual interest rate | 2.50% | 2.50% | |||||
Common stock, par value | $ / shares | $ 0.01 | ||||||
Number of trading days | d | 20 | 20 | |||||
Consecutive trading days | d | 30 | 30 | |||||
Conversion price percentage | 130% | 130% | |||||
Principal amount per share | $ / shares | $ 1,000 | $ 1,000 | |||||
Measurement period percentage | 98% | ||||||
Conversion price | $ / shares | $ 5.21 | $ 5.21 | |||||
Initial conversion price of premium percentage | 30% | ||||||
No of convertible shares | 191.8281 | ||||||
Redemption period start date | Mar. 06, 2024 | ||||||
Redemption price percentage | 100% | ||||||
Sinking fund | $ 0 | ||||||
Debt instrument redemption description | The Company may redeem for cash all or any portion of the Senior convertible notes, at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of common stock has been at least 130% of the conversion price for the Senior convertible notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Senior convertible notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company elects to redeem less than all of the outstanding Senior convertible notes, at least $75.0 million aggregate principal amount of Senior convertible notes must be outstanding and not subject to redemption as of the relevant redemption notice date. No sinking fund is provided for the Senior convertible notes. | ||||||
Percentage of repurchase price | 100% | ||||||
Debt default, description | If certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries) occur, 100% of the principal of and accrued and unpaid interest on the Senior convertible notes will automatically become due and payable. If an event of default with respect to the Senior convertible notes, other than certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries), occurs and is continuing, the trustee, by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Senior convertible notes by notice to the Company and the trustee, may, and the trustee at the request of such holders shall, declare 100% of the principal of and accrued and unpaid interest, if any, on all the Senior convertible notes to be due and payable. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company so elects, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture will, for the first 365 days after the occurrence of such an event of default consist exclusively of the right to receive additional interest on the Senior convertible notes as set forth in the Indenture | ||||||
Proceeds from offering after deducting initial purchasers discounts and commissions and estimated offering expenses payable | $ 222,700,000 | ||||||
Unamortized debt issuance cost | $ 3,100,000 | $ 4,600,000 | |||||
Senior Convertible Notes | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding principal amount redeemed | $ 75,000,000 | ||||||
Senior Convertible Notes | Private Placement | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 230,000,000 |
Borrowings - MidCap Credit Faci
Borrowings - MidCap Credit Facility - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||||||||
Apr. 22, 2021 USD ($) | Aug. 06, 2019 | Aug. 31, 2022 | Apr. 30, 2021 USD ($) | Dec. 31, 2020 Installment | Aug. 31, 2019 USD ($) Installment | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | Oct. 31, 2021 shares | Mar. 31, 2021 USD ($) | ||
Debt Instrument [Line Items] | ||||||||||||
Maturity date | Dec. 31, 2025 | Nov. 03, 2024 | ||||||||||
Debt instrument payment term description | Principal on each term loan advance under Tranche 1 and Tranche 2 are payable in 24 equal monthly installments that began September 1, 2023, until paid in full on August 1, 2025. | |||||||||||
Unamortized debt discount | $ 313,000 | |||||||||||
On or After April 23, 2023 Through Maturity Date | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Early Termination Fees Percentage | 1% | |||||||||||
MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Prepaid of borrowing | $ 10,000,000 | $ 10,000,000 | ||||||||||
Principal prepayment against outstanding term loans | $ 10,000,000 | |||||||||||
Debt instrument, prepayment penalty | 1,000,000 | 1,000,000 | ||||||||||
Unamortized debt discount | 100,000 | $ 200,000 | ||||||||||
Debt Instrument unamortized prepayment penalty. | $ 200,000 | $ 500,000 | ||||||||||
Minimum cash covenant | $ 90,000,000 | |||||||||||
Interest on loans increased, percentage | 2% | |||||||||||
MidCap Credit Facility | SOFR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate floor | 1% | 1% | [1] | 1% | ||||||||
Tranche 1 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Maturity date | Aug. 01, 2025 | |||||||||||
Debt Instrument, Interest Rate, Effective Percentage | 8.25% | |||||||||||
Debt Instrument Payment Number of Equal Monthly Installments | Installment | 24 | |||||||||||
Line Of Credit Facility Principal Payment Start Date | Sep. 01, 2023 | |||||||||||
Tranche 1 | SOFR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 6.25% | |||||||||||
Interest rate floor | 1% | |||||||||||
Tranche 1 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Advance of borrowing | $ 40,000,000 | |||||||||||
Warrants to purchase of common stock | shares | 1,171,614 | |||||||||||
Tranche 2 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Maturity date | Aug. 01, 2025 | |||||||||||
Debt Instrument, Interest Rate, Effective Percentage | 8.25% | 8.25% | ||||||||||
Debt Instrument Payment Number of Equal Monthly Installments | Installment | 24 | |||||||||||
Line Of Credit Facility Principal Payment Start Date | Sep. 01, 2023 | |||||||||||
Tranche 2 | SOFR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 6.25% | |||||||||||
Interest rate floor | 1% | |||||||||||
Tranche 2 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Advance of borrowing | $ 10,000,000 | |||||||||||
Warrants to purchase of common stock | shares | 111,853 | |||||||||||
Tranche 3 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Amount available under credit facility | $ 60,000,000 | $ 60,000,000 | $ 25,000,000 | |||||||||
Debt instrument advance available date | Jun. 30, 2022 | |||||||||||
Debt instrument extended interest-only date | Sep. 01, 2023 | |||||||||||
Maturity date | Aug. 01, 2025 | |||||||||||
Debt instrument payment term description | The MidCap credit facility has been amended several times, including in April 2021 when the parties agreed to, among other things, (i) increase the amount available under the third advance from $25.0 million to $60.0 million and extend the date through which the third advance is available to June 30, 2022, (ii) amend the conditions to the third advance of $60.0 million being available to draw, including certain milestone conditions associated with Tyvaso DPI, (iii) remove the Company’s obligation to issue a warrant to purchase shares of the Company’s common stock upon drawing down the third advance, (iv) extend the interest-only period until September 1, 2023 and extend the maturity date until August 1, 2025, (v) amend the financial covenant relating to trailing 12 month minimum Afrezza net revenue, (vi) decrease the minimum cash covenant, (vii) decrease the interest rate on any amounts outstanding, now or in the future, under the MidCap credit facility, (viii) permit the Company to make certain acquisitions, subject to requirements, and (ix) permit the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash and short-term investments following such investment. | |||||||||||
Maximum value of additional investment limit | $ 9,000,000 | |||||||||||
Debt instrument minimum unrestricted cash and short-term investments | $ 90,000,000 | |||||||||||
[1] In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). |
Borrowings - Mann Group Promiss
Borrowings - Mann Group Promissory Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 22, 2021 | Aug. 31, 2019 USD ($) $ / shares | Dec. 31, 2020 USD ($) shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | ||
Debt Instrument [Line Items] | |||||||
Debt instrument payment term description | Principal on each term loan advance under Tranche 1 and Tranche 2 are payable in 24 equal monthly installments that began September 1, 2023, until paid in full on August 1, 2025. | ||||||
Maturity date | Dec. 31, 2025 | Nov. 03, 2024 | |||||
Loss on extinguishment of debt, net | $ 17,200 | ||||||
The Mann Group L L C | Convertible Promissory Note | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 8,800 | $ 8,800 | |||||
Senior notes, effective interest rate | 2.50% | [1] | 2.50% | ||||
Conversion price | $ / shares | $ 2.5 | ||||||
Debt issuance amount | $ 7,000 | $ 10,000 | $ 9,600 | ||||
Conversion of notes to common shares, shares | shares | 2,800,000 | 50,844 | 4,000,000 | 4,000,000 | |||
Interest Expense Debt | $ 300 | ||||||
Common stock issued to pay interest | shares | 50,844 | 75,487 | |||||
The Mann Group L L C | Convertible Promissory Note | Accrued Interest | |||||||
Debt Instrument [Line Items] | |||||||
Debt issuance amount | $ 3,000 | $ 200 | $ 10,000 | $ 400 | |||
Conversion of notes to common shares, shares | shares | 1,200,000 | ||||||
The Mann Group L L C | Promissory Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument fair value in excess of face amount | 18,400 | ||||||
Loss on extinguishment of debt, net | 22,100 | ||||||
Debt premium recognized in additional paid-in capital | $ 22,100 | ||||||
The Mann Group L L C | New Loan Arrangement | Convertible Promissory Note | |||||||
Debt Instrument [Line Items] | |||||||
No of convertible shares | 400 | ||||||
Principal amount per share | $ / shares | $ 1,000 | ||||||
Conversion price | $ / shares | $ 2.50 | ||||||
The Mann Group L L C | New Loan Arrangement | Promissory Notes | |||||||
Debt Instrument [Line Items] | |||||||
Senior notes, effective interest rate | 2.50% | 7% | |||||
Debt instrument payment term description | quarterly | ||||||
Debt instrument, date of first required interest payment | Oct. 01, 2019 | ||||||
The Mann Group L L C | Privately Negotiated Exchange Agreement | Loan Arrangement | |||||||
Debt Instrument [Line Items] | |||||||
Common stock price per share | $ / shares | $ 2.50 | ||||||
The Mann Group L L C | Privately Negotiated Exchange Agreement | Loan Arrangement | Convertible Promissory Note | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 35,000 | ||||||
The Mann Group L L C | Privately Negotiated Exchange Agreement | New Loan Arrangement | Non-Convertible Note | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 35,100 | ||||||
[1] In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). |
Borrowings - Schedule of Amorti
Borrowings - Schedule of Amortization of Premium and Accretion of Debt Issuance Costs (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |||
Amortization of debt discount and prepayment fee | $ 423 | $ 431 | $ 377 |
Amortization of debt issuance cost | $ 1,454 | $ 1,453 | $ 1,215 |
Collaboration, Licensing and _3
Collaboration, Licensing and Other Arrangements - Schedule of Revenue from Collaborations and Services (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | $ 198,962 | $ 99,770 | $ 75,442 |
United Therapeutics Corporation | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 124,786 | 42,851 | 34,412 |
United Therapeutics Corporation | Commercial Supply Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 52,025 | 24,826 | 267 |
United Therapeutics Corporation | License Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 782 | 2,426 | 34,145 |
Collaborations and services | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 52,954 | 27,924 | 36,274 |
Collaborations and services | License and Distribution Agreement | Cipla Ltd | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 147 | 147 | 147 |
Collaborations and services | Co-Promotion Agreement | Vertice Pharma | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 325 | 1,147 | |
Collaborations and services | Other | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 200 | 323 | |
Collaborations and services | Collaboration and License Agreement | Receptor CLA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 245 | ||
Collaborations and services | United Therapeutics Corporation | Commercial Supply Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | 52,025 | 24,826 | 267 |
Collaborations and services | United Therapeutics Corporation | License Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from collaborations and services | $ 782 | $ 2,426 | $ 34,145 |
Collaboration, Licensing and _4
Collaboration, Licensing and Other Arrangements - Schedule of Deferred Revenue Related to Revenue Recognized for Collaborations and Services (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Beginning balance | $ 39,417 | $ 20,370 |
Additions | 92,416 | 46,971 |
Revenue — collaborations and services | (52,954) | (27,924) |
Ending balance | $ 78,879 | $ 39,417 |
Collaboration, Licensing and _5
Collaboration, Licensing and Other Arrangements - Summary of UT Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from UT | $ 198,962 | $ 99,770 | $ 75,442 |
United Therapeutics Corporation | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from UT | 124,786 | 42,851 | 34,412 |
United Therapeutics Corporation | Commercial Supply Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from UT | 52,025 | 24,826 | 267 |
United Therapeutics Corporation | License Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from UT | 782 | 2,426 | $ 34,145 |
United Therapeutics Corporation | Royalties Arrangement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenue from UT | $ 71,979 | $ 15,599 |
Collaboration, Licensing and _6
Collaboration, Licensing and Other Arrangements - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Oct. 31, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Feb. 28, 2023 | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | $ 78,879,000 | $ 39,417,000 | $ 78,879,000 | $ 39,417,000 | $ 20,370,000 | ||||
Deferred revenue — current | 9,085,000 | 1,733,000 | 9,085,000 | 1,733,000 | |||||
Deferred revenue - non-current | $ 69,794,000 | 37,684,000 | 69,794,000 | 37,684,000 | |||||
Total revenue from UT | 198,962,000 | 99,770,000 | 75,442,000 | ||||||
Collaborations and services | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 52,954,000 | 27,924,000 | 36,274,000 | ||||||
AFREZZA product sales | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 74,029,000 | 56,247,000 | 39,168,000 | ||||||
United Therapeutics Corporation | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 124,786,000 | 42,851,000 | 34,412,000 | ||||||
United Therapeutics Corporation | Manufacturing Services | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Funding for development of alternative manufacturing processes | 2,300,000 | ||||||||
United Therapeutics Corporation | Commercialization And Continuous Improvement Activities | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Funding for capital improvements | 39,500,000 | ||||||||
Thirona Bio, Inc. | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Minimum amount to expended | $ 1,100,000 | ||||||||
Funded amount | $ 700,000 | ||||||||
Collaboration and License Agreement | United Therapeutics Corporation | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Royalty percentage | 10% | ||||||||
Royalty future net sales percentage | 1% | ||||||||
Royalty retaining percentage | 9% | ||||||||
License agreement description | There have been various amendments to the UT License Agreement and the CSA since inception. As amended, the term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) UT provides notice to the Company at least 24 months in advance of such renewal that UT does not wish to renew the CSA or (ii) the Company provides notice to UT at least 48 months in advance of such renewal that the Company does not wish to renew the CSA | ||||||||
Total anticipated cash flows | [1] | 722,300,000 | 722,300,000 | ||||||
Deferred revenue | $ 77,500,000 | 37,900,000 | $ 77,500,000 | 37,900,000 | |||||
Deferred revenue — current | 8,900,000 | 1,600,000 | 8,900,000 | 1,600,000 | |||||
Deferred revenue - non-current | 68,600,000 | 36,300,000 | 68,600,000 | 36,300,000 | |||||
Collaboration and License Agreement | United Therapeutics Corporation | Manufacturing Services | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total anticipated cash flows | 722,300,000 | 722,300,000 | |||||||
Allocated transaction price | 220,800,000 | ||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Manufacturing Services | Transaction Price For The Contractual Obligations | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total anticipated cash flows | 120,000,000 | 120,000,000 | |||||||
Collaboration and License Agreement | United Therapeutics Corporation | Next-Gen R&D Services | Transaction Price For The Performance Obligations | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total anticipated cash flows | 602,300,000 | 602,300,000 | |||||||
Commercial Supply Agreement | United Therapeutics Corporation | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 52,025,000 | 24,826,000 | 267,000 | ||||||
Commercial Supply Agreement | United Therapeutics Corporation | Collaborations and services | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 52,025,000 | 24,826,000 | 267,000 | ||||||
Supply and Distribution Agreement | AFREZZA product sales | Biomm | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | 0 | 0 | 0 | ||||||
License and Distribution Agreement | Cipla Ltd | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue | 1,400,000 | 1,500,000 | 1,400,000 | 1,500,000 | |||||
Deferred revenue — current | 200,000 | 100,000 | 200,000 | 100,000 | |||||
Deferred revenue - non-current | $ 1,200,000 | $ 1,400,000 | 1,200,000 | 1,400,000 | |||||
Marketing and distribution agreement date | 2018-05 | ||||||||
License and Distribution Agreement | Collaborations and services | Cipla Ltd | |||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Total revenue from UT | $ 147,000 | $ 147,000 | $ 147,000 | ||||||
[1] The total anticipated cash flow includes a transaction price of $ 120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA. |
Collaboration, Licensing and _7
Collaboration, Licensing and Other Arrangements - Revenue Allocation (Detail) - Collaboration and License Agreement - United Therapeutics Corporation - Over Time $ in Millions | 1 Months Ended |
Dec. 31, 2022 USD ($) | |
R&D Services and License | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Progress Measure | Ratably |
Recognition Period | Aug 2021 - Oct 2021 |
Next-Gen R&D Services | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Total transaction price | $ 10 |
Progress Measure | Input |
Recognition Period | % of completion of costs |
Collaboration, Licensing and _8
Collaboration, Licensing and Other Arrangements - Schedule of Revised Anticipated Cash Flows from Transactions Allocated Performance Obligations (Detail) - Collaboration and License Agreement - United Therapeutics Corporation $ in Millions | 1 Months Ended | |
Dec. 31, 2022 USD ($) | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Total anticipated cash flows | $ 722.3 | [1] |
R&D Services and License | Over Time | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Progress Measure | Ratably | |
Recognition Period | Aug 2021 - Oct 2021 | |
Next-Gen R&D Services | Over Time | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Anticipated Revenue Allocation | $ 10 | |
Progress Measure | Input | |
Recognition Period | % of completion of costs | |
Manufacturing Services and Product Sales | Point In Time | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Anticipated Revenue Allocation | $ 712.3 | [2] |
Recognition Period | Transfer of control | [2] |
Manufacturing Services | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Total anticipated cash flows | $ 722.3 | |
[1] The total anticipated cash flow includes a transaction price of $ 120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA. The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $ 220.8 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received. |
Collaboration, Licensing and _9
Collaboration, Licensing and Other Arrangements - Schedule of Revised Anticipated Cash Flows from Transactions Allocated Performance Obligations (Parenthetical) (Detail) - United Therapeutics Corporation - Collaboration and License Agreement $ in Millions | 1 Months Ended | |
Dec. 31, 2022 USD ($) | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total anticipated cash flows | $ 722.3 | [1] |
Manufacturing Services | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total anticipated cash flows | 722.3 | |
Allocated transaction price | 220.8 | |
Manufacturing Services | Transaction Price For The Contractual Obligations | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total anticipated cash flows | 120 | |
Next-Gen R&D Services | Transaction Price For The Performance Obligations | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total anticipated cash flows | $ 602.3 | |
[1] The total anticipated cash flow includes a transaction price of $ 120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA. |
Collaboration, Licensing and_10
Collaboration, Licensing and Other Arrangements - Additional Information (Detail 1) - License and Distribution Agreement - Cipla Ltd - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2018-06-01 $ in Millions | May 31, 2018 USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Deferred revenue recognition period | 15 years |
Anticipated Revenue Allocation | $ 2.2 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Detail) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Carrying Amount | MidCap Credit Facility | ||
Financial liabilities: | ||
Total financial liabilities fair value | $ 33 | $ 39.3 |
Carrying Amount | Senior Convertible Notes | ||
Financial liabilities: | ||
Total financial liabilities fair value | 226.9 | 225.4 |
Carrying Amount | Mann Group Convertible Notes | ||
Financial liabilities: | ||
Total financial liabilities fair value | 8.8 | 8.8 |
Carrying Amount | Milestone Rights | ||
Financial liabilities: | ||
Total financial liabilities fair value | 3.9 | 4.8 |
Carrying Amount | Contingent Milestone Liability | ||
Financial liabilities: | ||
Total financial liabilities fair value | 0.3 | 0.6 |
Carrying Amount | Financing Liability | ||
Financial liabilities: | ||
Total financial liabilities fair value | 104.1 | 104.1 |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | MidCap Credit Facility | ||
Financial liabilities: | ||
Total financial liabilities fair value | 35.5 | 41.1 |
Estimate of Fair Value Measurement | Senior Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 231.3 | 253.9 |
Estimate of Fair Value Measurement | Mann Group Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 14.4 | 20.8 |
Estimate of Fair Value Measurement | Milestone Rights | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 11.9 | 12.6 |
Estimate of Fair Value Measurement | Contingent Milestone Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 0.3 | 1 |
Estimate of Fair Value Measurement | Financing Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | $ 106.8 | $ 103.2 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Parenthetical) (Detail) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
MidCap Credit Facility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 12 | 12 |
Note payable, percentage of interest rate increases (decreases) | 2% | 2% |
MidCap Credit Facility | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 35 | $ 40 |
MidCap Credit Facility | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 36 | $ 42.4 |
Mann Group Convertible Notes | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 13 | 13 |
Note payable, percentage of interest rate increases (decreases) | 2% | 2% |
Mann Group Convertible Notes | Volatility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 62.7 | 77.8 |
Mann Group Convertible Notes | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 14.2 | $ 20.5 |
Mann Group Convertible Notes | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 14.7 | $ 21.2 |
Senior Convertible Notes | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 11 | 13 |
Note payable, percentage of interest rate increases (decreases) | 2% | 2% |
Senior Convertible Notes | Volatility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 62.7 | 75.8 |
Senior Convertible Notes | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 224.1 | $ 245 |
Senior Convertible Notes | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 238.9 | $ 263.4 |
Milestone Rights | Risk-Free Rate | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 3.88 | 3.99 |
Milestone Rights | Dividend Yield | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 0 | 0 |
Milestone Rights | Volatility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 50 | 50 |
Milestone Rights | Period | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 8 | 8 |
Milestone Rights | Credit Risk | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 17 | 17 |
Contingent Milestone Liability | Risk-Free Rate | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 4.01 | 4.01 |
Contingent Milestone Liability | Dividend Yield | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 0 | 0 |
Contingent Milestone Liability | Volatility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 43 | 43 |
Contingent Milestone Liability | Period | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 15 | 15 |
Contingent Milestone Liability | Credit Risk | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 17 | 17 |
Financing Liability | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 9.5 | 10 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jan. 01, 2024 | Feb. 28, 2021 | Feb. 28, 2018 | Dec. 31, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2023 | Oct. 31, 2021 | |
Class of Stock [Line Items] | |||||||||
Common stock, shares authorized | 800,000,000 | 400,000,000 | 400,000,000 | ||||||
Common stock, par value | $ 0.01 | $ 0.01 | |||||||
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||
Undesignated preferred stock, par value | $ 0.01 | $ 0.01 | |||||||
Common stock, shares issued | 270,034,495 | 263,793,305 | |||||||
Common stock, shares outstanding | 270,034,495 | 263,793,305 | |||||||
Undesignated preferred stock, shares outstanding | 0 | 0 | |||||||
Proceeds from market price stock purchase plan | $ 0.2 | $ 0.7 | $ 0.1 | ||||||
Market price stock purchase plan | 36,004 | 252,176 | 25,000 | ||||||
MidCap Credit Facility | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock, shares issued | 964,113 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,283,467 | ||||||||
Convertible Promissory Note | The Mann Group L L C | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of common stock to note holders | 2,800,000 | 50,844 | 4,000,000 | 4,000,000 | |||||
Conversion of notes accrued interest to common shares, value | $ 0.4 | ||||||||
Debt issuance amount | $ 7 | $ 10 | $ 9.6 | ||||||
Common stock issued to pay interest | 50,844 | 75,487 | |||||||
2024 Convertible Notes | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of common stock to note holders | 1,666,667 | ||||||||
Debt issuance amount | $ 5 | ||||||||
Tranche 1 | MidCap Credit Facility | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants to purchase of common stock | 1,171,614 | ||||||||
Tranche 2 | MidCap Credit Facility | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants to purchase of common stock | 111,853 | ||||||||
Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares sold during the period | 1,478,000 | 5,060,000 | 578,000 | ||||||
Contolled Equity Offering Sales Agreement | Cantor Fitzgerald | Common Stock | Maximum | |||||||||
Class of Stock [Line Items] | |||||||||
Amount of net proceeds from issuance of securities | $ 50 | ||||||||
At Market Issuance Sales Agreement | Cantor Fitzgerald | Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Amount of net proceeds from issuance of securities | $ 6.9 | $ 19.8 | $ 1.9 | ||||||
Number of shares sold during the period | 1,478,090 | 5,059,856 | 578,063 | ||||||
Exchange price per share | $ 4.66 | ||||||||
At Market Issuance Sales Agreement | Cantor Fitzgerald | Common Stock | Weighted Average | |||||||||
Class of Stock [Line Items] | |||||||||
Exchange price per share | $ 3.91 | $ 3.26 | |||||||
Subsequent Event | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from market price stock purchase plan | $ 1.4 | ||||||||
Market price stock purchase plan | 416,099 |
Earnings Per Common Share ("E_3
Earnings Per Common Share ("EPS") - Components of Basic and Diluted EPS Computations (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
EPS — basic and diluted: | |||
Net loss (numerator) | $ (11,938) | $ (87,400) | $ (80,926) |
Weighted average common shares (denominator) | 267,014 | 257,092 | 249,244 |
Net loss per share, Basic | $ (0.04) | $ (0.34) | $ (0.32) |
Net loss per share, Diluted | $ (0.04) | $ (0.34) | $ (0.32) |
Earnings Per Common Share ("E_4
Earnings Per Common Share ("EPS") - Potential Dilutive Securities Outstanding that are Considered Antidilutive (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 63,746,218 | 75,451,760 | 69,998,009 |
Senior Convertible Notes | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 44,120,463 | 44,120,463 | 44,120,463 |
RSUs and Market RSUs | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 7,855,144 | 18,886,710 | 7,609,025 |
Common Stock Options and PNQs | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 8,400,611 | 9,074,587 | 10,655,146 |
Mann Group Convertible Notes | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 3,370,000 | 3,370,000 | 7,370,000 |
Employee Stock Purchase Plan | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from computation of earnings per share | 243,375 |
Earnings Per Common Share ("E_5
Earnings Per Common Share ("EPS") - Potential Dilutive Securities Outstanding that are Considered Antidilutive (Parenthetical) (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
RSU | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Share delivery percentage in accordance with valuation assessment obtained | 0% | 140% | 0% |
Stock Award Plans - Additional
Stock Award Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||||
Jul. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2023 | May 31, 2020 | May 16, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity incentive plan, number of shares available for grant increased by shares | 3,000,000 | ||||||
Stock-based compensation | $ 17,649,000 | $ 13,447,000 | $ 12,200,000 | ||||
Options issued or granted | 0 | 0 | |||||
Fair value of stock options vested | $ 2,800,000 | $ 3,200,000 | 2,300,000 | ||||
Total intrinsic value of options exercised | 1,300,000 | 2,400,000 | 1,700,000 | ||||
Cash received from the exercise of options | 1,200,000 | 3,000,000 | 1,000,000 | ||||
Total fair value of restricted stock units vested | 20,600,000 | 4,400,000 | 6,700,000 | ||||
Total grant date fair value of restricted stock units outstanding | 57,000,000 | 43,200,000 | 19,300,000 | ||||
Issuance of common stock under employee stock purchase plan | 1,668,000 | 2,082,000 | 1,090,000 | ||||
Common Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Issuance of common stock under employee stock purchase plan | $ 5,000 | $ 6,000 | $ 5,000 | ||||
Issuance of common stock under employee stock purchase plan (in shares) | 507,000 | 686,000 | 527,000 | ||||
ESPP | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock available for issuance | 2,900,000 | ||||||
Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Issuance of common stock under employee stock purchase plan | $ 25,000 | ||||||
Issuance of common stock under employee stock purchase plan (in shares) | 5,000 | ||||||
Employee | ESPP | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Discount on purchase price percentage of fair market value | 85% | ||||||
Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 10 years | ||||||
Unrecognized compensation expense, weighted average period for recognition | 2 years 1 month 9 days | 2 years 2 months 19 days | |||||
Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 4 years | ||||||
Unrecognized compensation expense, weighted average period for recognition | 2 months 26 days | ||||||
Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 36 months | ||||||
Vesting rights percentage | 25% | ||||||
Restricted Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 4 years | ||||||
Restricted Stock | Tranche One | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting rights percentage | 25% | ||||||
RSUs | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Grant date fair value per share | $ 9.40 | ||||||
Vesting date | Jul. 15, 2026 | ||||||
Common stock price per share | $ 4.55 | ||||||
Risk-free interest rate | 4.19% | ||||||
Volatility | 74% | ||||||
Dividend yield | 0% | ||||||
Unrecognized compensation expense related to non-option | $ 16,400,000 | ||||||
RSUs | Less than 25th Percentile | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentile | 25% | ||||||
Percent of target | 0% | ||||||
RSUs | 25th Percentile | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentile | 25% | ||||||
Percent of target | 50% | ||||||
RSUs | 50th Percentile | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentile | 50% | ||||||
Percent of target | 100% | ||||||
RSUs | 75th Percentile | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentile | 75% | ||||||
Percent of target | 200% | ||||||
RSUs | 90th Percentile or Higher | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentile | 90% | ||||||
RSUs | Maximum | 90th Percentile or Higher | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percent of target | 300% | ||||||
RSUs and Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation | $ 17,000,000 | $ 12,800,000 | $ 11,500,000 | ||||
Employee Stock Purchase Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation | 600,000 | 600,000 | 700,000 | ||||
Performance-based Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost | 300,000 | 100,000 | $ 100,000 | ||||
Unrecognized compensation expense related to options | 0 | $ 200,000 | |||||
Options and Performance-based Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Unrecognized compensation expense related to options | $ 600,000 | ||||||
2018 Equity Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity incentive plan, number of shares available for grant increased by shares | 25,000,000 | ||||||
Exercise or strike price of fair market value of underlying common stock on date of grant reacquired or withheld | 100% | ||||||
2013 Equity Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity incentive plan, shares | 0 |
Stock Award Plans - Stock Based
Stock Award Plans - Stock Based Award Plans (Detail) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 8,400,611 | 9,074,587 |
Outstanding Restricted Stock Units | 12,363,934 | 11,838,329 |
Shares Available for Future Issuance | 26,374,063 | |
2013 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 2,966,524 | |
2018 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 5,434,087 | |
Outstanding Restricted Stock Units | 12,363,934 | |
Shares Available for Future Issuance | 26,374,063 |
Stock Award Plans - Stock Bas_2
Stock Award Plans - Stock Based Compensation Expense Recognized in Consolidated Statements of Operations by Category (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 17,649 | $ 13,447 | $ 12,200 |
Cost of Goods Sold | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 1,589 | 329 | 407 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 1,442 | 1,044 | 614 |
Cost of Revenue - Collaborations and Services | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 897 | 1,425 | 1,708 |
Selling | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 2,291 | 1,194 | 2,578 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 11,430 | $ 9,455 | $ 6,893 |
Stock Award Plans - Summary of
Stock Award Plans - Summary of Stock Options Outstanding (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Outstanding at January 1, 2023 | 9,074,587 | |
Exercised | (445,376) | |
Forfeited | (3,420) | |
Expired | (225,180) | |
Outstanding at December 31, 2023 | 8,400,611 | 9,074,587 |
Exercisable at December 31, 2023 | 7,938,892 | |
Weighted Average Exercise Price per Share | ||
Outstanding at January 1, 2023 | $ 3.06 | |
Exercised | 1.57 | |
Forfeited | 2.53 | |
Expired | 30.97 | |
Outstanding at December 31, 2023 | 2.39 | $ 3.06 |
Exercisable at December 31, 2023 | $ 2.40 | |
Weighted Average Remaining Contractual Term (Years) | ||
Outstanding | 4 years 25 days | 5 years 1 month 6 days |
Exercisable at December 31, 2023 | 4 years 1 month 13 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Outstanding | $ 15,153 | $ 29,512 |
Exercisable at December 31, 2023 | $ 14,450 |
Stock Award Plans - Summary o_2
Stock Award Plans - Summary of Restricted Stock Unit Activity (Detail) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Number of Shares | |
Outstanding at January 1, 2023 | shares | 11,838,329 |
Granted | shares | 7,531,650 |
Vested | shares | (6,053,264) |
Forfeited | shares | (952,781) |
Outstanding at December 31, 2023 | shares | 12,363,934 |
Weighted Average Grant Date Fair Value per Share | |
Outstanding at January 1, 2023 | $ / shares | $ 3.65 |
Granted | $ / shares | 5.17 |
Vested | $ / shares | 3.41 |
Forfeited | $ / shares | 4.80 |
Outstanding at December 31, 2023 | $ / shares | $ 4.61 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | 1 Months Ended | 12 Months Ended | |||||||||||
Dec. 27, 2023 USD ($) ConsecutiveMonth | Nov. 08, 2021 USD ($) | Feb. 28, 2023 USD ($) | Jun. 30, 2022 USD ($) | Nov. 30, 2021 USD ($) | Nov. 30, 2017 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 EUR (€) | Sep. 30, 2023 EUR (€) | Jun. 30, 2023 USD ($) | Jul. 01, 2013 USD ($) | |
Commitments And Contingencies [Line Items] | |||||||||||||
Litigation settlement amount | $ 200,000 | ||||||||||||
Milestone liabilities | 3,452,000 | $ 4,524,000 | |||||||||||
Milestone payment | (924,000) | (1,088,000) | $ (5,000,000) | ||||||||||
Operating lease costs | 1,675,000 | 1,525,000 | $ 863,000 | ||||||||||
Financing liability | 104,100,000 | 104,100,000 | |||||||||||
Financing liability, long term | 94,319,000 | 94,512,000 | |||||||||||
Financing liability, short term | 9,809,000 | 9,565,000 | |||||||||||
Cash paid for interest on financing liability | $ 9,600,000 | 9,600,000 | |||||||||||
Supply Agreement expiration period | Dec. 31, 2034 | ||||||||||||
Supply Agreement renewal period | 2 years | ||||||||||||
Loss on purchase commitments | € | € 59.5 | € 61.1 | |||||||||||
Operating lease, right-of-use asset | $ 4,685,000 | $ 6,714,000 | |||||||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets | Other assets | ||||||||||
Operating lease, liability | $ 5,348,000 | $ 6,647,000 | |||||||||||
Description of right to extension of lease term | The Company has no further right to extend the lease term beyond July 31, 2028. | ||||||||||||
Tyvaso DPI | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Royalty commencement date | Oct. 01, 2023 | ||||||||||||
Royalty termination date | Dec. 31, 2042 | ||||||||||||
Insulin | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Loss on purchase commitments | $ 64,800,000 | 72,300,000 | |||||||||||
Equipment | V-Go | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Lease Cost | $ 14,370 | ||||||||||||
Master Lease Agreement with Enterprise | Vehicle Leases | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Operating lease rent expenses | 100,000 | ||||||||||||
Marlborough Lease | Buildings | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Operating lease rent expenses | $ 28,895 | ||||||||||||
Percentage of annual increase in lease payment | 3% | ||||||||||||
Casper L L C | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Sale price | $ 102,300,000 | $ 102,300,000 | |||||||||||
Lease initial term | 20 years | ||||||||||||
Lease renewal option | 4 years | ||||||||||||
Lease renewal options | renewal options of five years | ||||||||||||
Lessee,option to extend [true false] | true | ||||||||||||
Operating lease costs | $ 9,500,000 | ||||||||||||
Lease, description | The total annual rent under the Lease starts at approximately $9.5 million per year, subject to a 50% rent abatement during the first year of the Lease, and will increase annually by (i) 2.5% in the second through fifth year of the Lease and (ii) 3% in the sixth and each subsequent year of the Lease, including any renewal term. | ||||||||||||
Security deposit | $ 2,000,000 | ||||||||||||
Lease repurchase description | the Company has four options to repurchase the Property, in 2026, 2031, 2036 and 2041, for the greater of (i) $102.3 million and (ii) the fair market value of the Property. | ||||||||||||
Minimum | Casper L L C | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Lease repurchase, amount | $ 102,300,000 | ||||||||||||
Deerfield | Milestone Rights Liability | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Contingent liability for milestone payments | $ 5,000,000 | $ 5,000,000 | |||||||||||
Contingent liability remain payable | 900,000 | 1,100,000 | $ 55,000,000 | ||||||||||
Remaining milestone rights liability | 3,900,000 | 4,800,000 | |||||||||||
Milestone rights liability, current | 800,000 | 900,000 | |||||||||||
Milestone liabilities | 3,100,000 | $ 3,900,000 | |||||||||||
Deerfield | Milestone Rights Liability | Maximum | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Contingent liability for milestone payments | $ 90,000,000 | ||||||||||||
Russell Ranch Road II LLC | Office Lease | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Operating lease rent expenses | $ 79,543 | ||||||||||||
Percentage of annual increase in lease payment | 3% | ||||||||||||
Russell Ranch Road II LLC | Maximum | Office Lease | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Reimbursement for tenant improvements | $ 900,000 | ||||||||||||
Additional base rent concession | $ 700,000 | ||||||||||||
Sagard | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Upfront proceeds | $ 150,000,000 | ||||||||||||
Reimbursements | $ 400,000 | ||||||||||||
Percentage of royalty on future net sales | 1% | ||||||||||||
Sagard | Remainder of Year | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Royalties | $ 0 | ||||||||||||
Sagard | Tyvaso DPI | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Purchase price | 200,000,000 | ||||||||||||
Sagard | Tyvaso DPI | Net Sales Threshold A | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Milestone payment | (50,000,000) | ||||||||||||
Net sales | $ 1,900,000,000 | ||||||||||||
Number of consecutive months | ConsecutiveMonth | 12 | ||||||||||||
Sagard | Tyvaso DPI | Net Sales Threshold B | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Milestone payment | $ (45,000,000) | ||||||||||||
Net sales | $ 2,300,000,000 | ||||||||||||
Number of consecutive months | ConsecutiveMonth | 12 | ||||||||||||
Sagard | Tyvaso DPI | Net Sales Thresholds A and B | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Net sales | $ 3,500,000,000 | ||||||||||||
Sagard | Royalty Liability | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Royalty rights | 1% | ||||||||||||
Transaction costs | $ 4,400,000 | ||||||||||||
Percentage of Future Royalty Revenues | 10% | ||||||||||||
Effective interest rate | 1,110% | ||||||||||||
Non-cash interest expense | 200,000 | ||||||||||||
Non-cash revenue recognized | $ 2,100,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Financing Liability Lease Term and Discount Rate (Detail) | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term (in years) | 17 years 9 months 18 days | 18 years 9 months 18 days |
Weighted average discount rate | 9% | 9% |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Financing Liability Costs (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Interest expense on financing liability | $ 9,825 | $ 9,758 | $ 1,373 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Financing Liability Payments (Detail) $ in Thousands | Dec. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
2024 | $ 10,018 |
2025 | 10,269 |
2026 | 10,533 |
2027 | 10,849 |
2028 | 11,174 |
Thereafter | 177,278 |
Total | 230,121 |
Interest payments | (123,318) |
Debt issuance costs | (2,675) |
Total financing liability | $ 104,128 |
Commitments and Contingencies_5
Commitments and Contingencies - Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements (Detail) - EUR (€) € in Millions | Dec. 31, 2023 | Sep. 30, 2023 |
Purchase Obligation, Fiscal Year Maturity [Abstract] | ||
Remaining Purchase Commitments, 2023 | € 2.4 | |
Remaining Purchase Commitments, 2024 | € 2.9 | 14.6 |
Remaining Purchase Commitments, 2025 | 15.5 | |
Remaining Purchase Commitments, 2026 | 4.2 | 19.4 |
Remaining Purchase Commitments, 2027 | 6 | 9.2 |
Remaining Purchase Commitments, 2028 | 6 | |
Remaining Purchase Commitments, 2029 | 6 | |
Remaining Purchase Commitments, 2030 | 6 | |
Remaining Purchase Commitments, 2031 | 8 | |
Remaining Purchase Commitments, 2032 | 8 | |
Remaining Purchase Commitments, 2033 | 8 | |
Remaining Purchase Commitments, 2034 | 4.4 | |
Remaining Purchase Commitments, Total | 59.5 | € 61.1 |
Estimated Capacity Fees, 2025 | 1.5 | |
Estimated Capacity Fees, 2026 | 2 | |
Estimated Capacity Fees, 2027 | 1 | |
Estimated Capacity Fees, 2028 | 1 | |
Estimated Capacity Fees, 2029 | 1 | |
Estimated Capacity Fees, 2030 | 1 | |
Estimated Capacity Fees, 2031 | 0.5 | |
Estimated Capacity Fees, 2032 | 0.5 | |
Estimated Capacity Fees, 2033 | 0.5 | |
Estimated Capacity Fees, 2034 | 0.5 | |
Estimated Capacity Fees, Total | € 9.5 |
Commitments and Contingencies_6
Commitments and Contingencies - Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements (Parenthetical) (Detail) | Dec. 31, 2023 EUR (€) |
Purchase Obligation, Fiscal Year Maturity [Abstract] | |
Capacity fee | € 750,000 |
Commitments and Contingencies_7
Commitments and Contingencies - Schedule of Lease Term and Discount Rate (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease, right-of-use asset | $ 4,685 | $ 6,714 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets | |
Operating lease liability-current | $ 1,423 | $ 1,304 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities | |
Operating lease liability | $ 3,925 | $ 5,343 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Operating lease liability | Operating lease liability | |
Total | $ 5,348 | $ 6,647 | |
Weighted average remaining lease term (in years) | 3 years 8 months 12 days | 4 years 7 months 6 days | |
Incremental borrowing rate | 7.30% | 7.30% | 7.25% |
Commitments and Contingencies_8
Commitments and Contingencies - Summary of Lease Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease costs | $ 1,675 | $ 1,525 | $ 863 |
Variable lease costs | 104 | 274 | 515 |
Cash paid | $ 1,068 | $ 1,823 | $ 1,867 |
Commitments and Contingencies_9
Commitments and Contingencies - Schedule of Future Minimum Office And Vehicle Lease Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments And Contingencies [Line Items] | ||
Operating lease, liability | $ 5,348 | $ 6,647 |
office and vehicle | ||
Commitments And Contingencies [Line Items] | ||
Year 1 | 1,496 | |
Year 2 | 1,861 | |
Year 3 | 1,140 | |
Year 4 | 1,072 | |
Year 5 | 643 | |
Total | 6,212 | |
Interest expense | (864) | |
Operating lease, liability | $ 5,348 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Benefit Plans And Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employer matching contribution deferral rate | 50% | 50% | 50% |
Total discretionary matching contributions | $ 2.9 | $ 1.8 | $ 1.5 |
One Year Service | |||
Defined Benefit Plans And Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employers matching contribution vesting percentage | 50% | ||
Two Year Service | |||
Defined Benefit Plans And Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employers matching contribution vesting percentage | 100% | ||
Maximum | |||
Defined Benefit Plans And Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employer matching contribution, percent of employees' compensation | 10% | 10% | 10% |
Loss from Continuing Operations
Loss from Continuing Operations Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (10,377) | $ (87,400) | $ (80,926) |
Loss before income tax expense | $ (10,377) | $ (87,400) | $ (80,926) |
Provision for Income Taxes (Det
Provision for Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current | |||
U.S. state | $ 1,555,000 | ||
Total current | 1,555,000 | ||
Deferred | |||
U.S. federal | 190,000 | $ (5,606,000) | $ (5,170,000) |
U.S. state | 7,002,000 | (4,334,000) | (14,461,000) |
Total deferred | 6,812,000 | (9,940,000) | (19,631,000) |
Valuation allowance | 6,800,000 | $ 9,940,000 | $ 19,631,000 |
Net deferred | 6 | ||
Total | $ 1,561,000 |
Components of Net Deferred Tax
Components of Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 506,641 | $ 542,537 |
Research and development credits | 77,007 | 78,804 |
Capitalized research costs | 14,225 | 4,369 |
Milestone Rights | 1,006 | 1,331 |
Accrued expenses | 3,760 | 2,675 |
Loss on purchase commitment | 22,806 | 23,117 |
Non-qualified stock option expense | 3,559 | 7,686 |
Capitalized patent costs | 6,720 | 8,058 |
Other | 3,405 | 3,204 |
Lease liability | 1,280 | 1,624 |
Interest expense limitation | 2,782 | 10,991 |
Depreciation | 21,134 | 22,157 |
Deferred product revenue and costs | 346 | 370 |
Sale of future royalties | 34,848 | |
Total deferred tax assets | 699,519 | 706,923 |
Valuation allowance | (698,228) | (705,034) |
Net deferred tax assets | 1,291 | 1,889 |
Deferred tax liabilities: | ||
Right of use asset | (1,121) | (1,640) |
Other prepaids | (176) | (249) |
Total deferred tax liabilities | (1,297) | $ (1,889) |
Net deferred tax assets | $ (6) |
Effective Tax Rate (Detail)
Effective Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Federal tax benefit rate | 21% | 21% | 21% |
State tax expense (net of federal benefit) | (11.80%) | 0% | 0% |
Permanent items | (2.80%) | (0.10%) | (4.40%) |
Officers compensation | (35.30%) | (1.10%) | 0% |
Stock based compensation | (5.60%) | 0.40% | 0.30% |
Tax attribute expirations | 0.40% | (13.20%) | (5.90%) |
Valuation allowance | 9.10% | (7.20%) | (11.20%) |
Other deferred adjustments | 10% | 0.20% | 0.20% |
Effective income tax rate | (15.00%) | 0% | 0% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2004 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||||
Valuation allowance of deferred tax assets | $ 698,228,000 | $ 705,034,000 | ||
Change in the valuation allowance | 6,800,000 | 9,940,000 | $ 19,631,000 | |
Federal operating loss carryforwards | 2,000,000,000 | |||
State operating loss carryforwards | 1,300,000,000 | |||
Federal operation loss carryforwards, not subject to expiration | $ 494,000,000 | |||
Operating loss carryforwards, limitations on use | Pursuant to IRC Sections 382 and 383, annual use of the Company’s federal and California net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. | |||
Net operating loss carryforwards | $ 105,800,000 | |||
Net operating loss and credit carryforwards, annual use limitation | $ 13,000,000 | |||
Research and development credit expired | 2023 | |||
Research and development credits expire | $ 1,100,000 | |||
Unrecognized income tax interest and penalties | 0 | $ 0 | $ 0 | |
Federal | ||||
Income Taxes [Line Items] | ||||
Research and development credits not expire | $ 54,200,000 | |||
Research and development credits begin to expire | 2024 | |||
State | ||||
Income Taxes [Line Items] | ||||
Research and development credits not expire | $ 22,800,000 | |||
Connecticut | ||||
Income Taxes [Line Items] | ||||
Research and development credits not expire | $ 19,800,000 |
Income Taxes - Summary of Posit
Income Taxes - Summary of Positions for which Significant Change in Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Beginning of Year | $ 268,902 | $ 268,902 | $ 268,902 |
Gross increases for tax positions of prior years | 0 | 0 | 0 |
End of Year | $ 268,902 | $ 268,902 | $ 268,902 |